Sample records for laboratory trials showed

  1. Laboratory and software applications for clinical trials: the global laboratory environment. (United States)

    Briscoe, Chad


    The Applied Pharmaceutical Software Meeting is held annually. It is sponsored by The Boston Society, a not-for-profit organization that coordinates a series of meetings within the global pharmaceutical industry. The meeting generally focuses on laboratory applications, but in recent years has expanded to include some software applications for clinical trials. The 2011 meeting emphasized the global laboratory environment. Global clinical trials generate massive amounts of data in many locations that must be centralized and processed for efficient analysis. Thus, the meeting had a strong focus on establishing networks and systems for dealing with the computer infrastructure to support such environments. In addition to the globally installed laboratory information management system, electronic laboratory notebook and other traditional laboratory applications, cloud computing is quickly becoming the answer to provide efficient, inexpensive options for managing the large volumes of data and computing power, and thus it served as a central theme for the meeting.

  2. Obtaining valid laboratory data in clinical trials conducted in resource diverse settings: lessons learned from a microbicide phase III clinical trial.

    Directory of Open Access Journals (Sweden)

    Tania Crucitti


    Full Text Available Over the last decade several phase III microbicides trials have been conducted in developing countries. However, laboratories in resource constrained settings do not always have the experience, infrastructure, and the capacity to deliver laboratory data meeting the high standards of clinical trials. This paper describes the design and outcomes of a laboratory quality assurance program which was implemented during a phase III clinical trial evaluating the efficacy of the candidate microbicide Cellulose Sulfate 6% (CS [1].In order to assess the effectiveness of CS for HIV and STI prevention, a phase III clinical trial was conducted in 5 sites: 3 in Africa and 2 in India. The trial sponsor identified an International Central Reference Laboratory (ICRL, responsible for the design and management of a quality assurance program, which would guarantee the reliability of laboratory data. The ICRL provided advice on the tests, assessed local laboratories, organized trainings, conducted supervision visits, performed re-tests, and prepared control panels. Local laboratories were provided with control panels for HIV rapid tests and Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG amplification technique. Aliquots from respective control panels were tested by local laboratories and were compared with results obtained at the ICRL.Overall, good results were observed. However, discordances between the ICRL and site laboratories were identified for HIV and CT/NG results. One particular site experienced difficulties with HIV rapid testing shortly after study initiation. At all sites, DNA contamination was identified as a cause of invalid CT/NG results. Both problems were timely detected and solved. Through immediate feedback, guidance and repeated training of laboratory staff, additional inaccuracies were prevented.Quality control guidelines when applied in field laboratories ensured the reliability and validity of final study data. It is essential that sponsors

  3. Laboratory research at the clinical trials of Veterinary medicinal Products


    ZHYLA M.I.


    The article analyses the importance of laboratory test methods, namely pathomorfological at conduct of clinical trials. The article focuses on complex laboratory diagnostics at determination of clinical condition of animals, safety and efficacy of tested medicinal product.

  4. Biochar: from laboratory mechanisms through the greenhouse to field trials (United States)

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


    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

  5. An inter-laboratory trial of the unified BARGE bioaccessibility method for arsenic, cadmium and lead in soil

    International Nuclear Information System (INIS)

    Wragg, Joanna; Cave, Mark; Basta, Nick; Brandon, Esther; Casteel, Stan; Denys, Sebastien; Gron, Christian; Oomen, Agnes; Reimer, Kenneth; Tack, Karine; Van de Wiele, Tom


    The Bioaccessibility Research Group of Europe (BARGE) has carried out an inter-laboratory trial of a proposed harmonised in vitro physiologically based ingestion bioaccessibility procedure for soils, called the Unified BARGE Method (UBM). The UBM includes an initial saliva phase and simulated stomach and intestine compartments. The trial involved the participation of seven laboratories (five European and two North American) providing bioaccessibility data for As (11 samples), Cd (9 samples) and Pb (13 samples) using soils with in vivo relative bioavailability data measured using a swine model. The results of the study were compared with benchmark criteria for assessing the suitability of the UBM to provide data for human health risk assessments. Mine waste and slag soils containing high concentrations of As caused problems of poor repeatability and reproducibility which were alleviated when the samples were run at lower soil to solution ratios. The study showed that the UBM met the benchmark criteria for both the stomach and stomach and intestine phase for As. For Cd, three out of four criteria were met for the stomach phase but only one for the stomach and intestine phase. For Pb two, out of four criteria were met for the stomach phase and none for the stomach and intestine phase. However, the study recommends tighter control of pH in the stomach phase extraction to improve between-laboratory variability, more reproducible in vivo validation data and that a follow up inter-laboratory trial should be carried out.

  6. An inter-laboratory trial of the unified BARGE bioaccessibility method for arsenic, cadmium and lead in soil

    Energy Technology Data Exchange (ETDEWEB)

    Wragg, Joanna [British Geological Survey, Nottingham (United Kingdom); Cave, Mark, E-mail: [British Geological Survey, Nottingham (United Kingdom); Basta, Nick [School of Environment and Natural Resources, Ohio State University, Columbus, OH, 43210-1085 (United States); Brandon, Esther [National Institute for Public Health and the Environment, Bilthoven (Netherlands); Casteel, Stan [College of Veterinary Medicine, University of Missouri, 65205 (United States); Denys, Sebastien [INERIS, Parc Technologique Alata, Verneuil-en-Halatte (France); Gron, Christian [DHI Water Environment Health, Horsholm (Denmark); Oomen, Agnes [National Institute for Public Health and the Environment, Bilthoven (Netherlands); Reimer, Kenneth [Environmental Sciences Group, Royal Military College of Canada, Kingston, Ontario (Canada); Tack, Karine [INERIS, Parc Technologique Alata, Verneuil-en-Halatte (France); Van de Wiele, Tom [Laboratory of Microbial Ecology and Technology, University of Ghent, Ghent (Belgium)


    The Bioaccessibility Research Group of Europe (BARGE) has carried out an inter-laboratory trial of a proposed harmonised in vitro physiologically based ingestion bioaccessibility procedure for soils, called the Unified BARGE Method (UBM). The UBM includes an initial saliva phase and simulated stomach and intestine compartments. The trial involved the participation of seven laboratories (five European and two North American) providing bioaccessibility data for As (11 samples), Cd (9 samples) and Pb (13 samples) using soils with in vivo relative bioavailability data measured using a swine model. The results of the study were compared with benchmark criteria for assessing the suitability of the UBM to provide data for human health risk assessments. Mine waste and slag soils containing high concentrations of As caused problems of poor repeatability and reproducibility which were alleviated when the samples were run at lower soil to solution ratios. The study showed that the UBM met the benchmark criteria for both the stomach and stomach and intestine phase for As. For Cd, three out of four criteria were met for the stomach phase but only one for the stomach and intestine phase. For Pb two, out of four criteria were met for the stomach phase and none for the stomach and intestine phase. However, the study recommends tighter control of pH in the stomach phase extraction to improve between-laboratory variability, more reproducible in vivo validation data and that a follow up inter-laboratory trial should be carried out.

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


    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.

  8. A step forward in molecular diagnostics of lyssaviruses--results of a ring trial among European laboratories.

    Directory of Open Access Journals (Sweden)

    Melina Fischer

    Full Text Available Rabies is a lethal and notifiable zoonotic disease for which diagnostics have to meet the highest standards. In recent years, an evolution was especially seen in molecular diagnostics with a wide variety of different detection methods published. Therefore, a first international ring trial specifically designed on the use of reverse transcription polymerase chain reaction (RT-PCR for detection of lyssavirus genomic RNA was organized. The trial focussed on assessment and comparison of the performance of conventional and real-time assays. In total, 16 European laboratories participated. All participants were asked to investigate a panel of defined lyssavirus RNAs, consisting of Rabies virus (RABV and European bat lyssavirus 1 and 2 (EBLV-1 and -2 RNA samples, with systems available in their laboratory. The ring trial allowed the important conclusion that conventional RT-PCR assays were really robust assays tested with a high concordance between different laboratories and assays. The real-time RT-PCR system by Wakeley et al. (2005 in combination with an intercalating dye, and the combined version by Hoffmann and co-workers (2010 showed good sensitivity for the detection of all RABV samples included in this test panel. Furthermore, all used EBLV-specific assays, real-time RT-PCRs as well as conventional RT-PCR systems, were shown to be suitable for a reliable detection of EBLVs. It has to be mentioned that differences were seen in the performance between both the individual RT-PCR systems and the laboratories. Laboratories which used more than one molecular assay for testing the sample panel always concluded a correct sample result. Due to the markedly high genetic diversity of lyssaviruses, the application of different assays in diagnostics is needed to achieve a maximum of diagnostic accuracy. To improve the knowledge about the diagnostic performance proficiency testing at an international level is recommended before using lyssavirus molecular

  9. Bamboo as Soil Reinforcement: A Laboratory Trial

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    Alhaji Mohammed MUSTAPHA


    Full Text Available A lateritic soil classified as A-6 under AASHTO soil classification system was reinforced with 0, 1, 2 and 3 bamboo specimens at laboratory trial level to evaluate its unconfined compressive strength (UCS and modulus of rigidity. The soil specimens were molded in cylindrical form of 38mm diameter and 76mm height while the bamboo specimens were trimmed in to circular plates of 34mm diameter and 3mm thickness. The trial soil specimens are: soil specimen without bamboo specimen (0 bamboo, soil specimen with one bamboo specimen in the center (1 bamboo, soil specimen with one bamboo specimen on top and one at the bottom (2 bamboos and soil specimen with one bamboo specimen on top, center and bottom (3 bamboos. Though, the dry density of the molded soil specimen decreased from 1.638Mg/m3 at 0 bamboo to 1.470Mg/m2 at 3 bamboos, the UCS increased from 226KN/m2 at 0 bamboo to 621KN/m2 at 3 bamboos. Also, for each of the 3 percentage strains (0.5, 1.0 and 1.5% considered, the modulus of rigidity increased with bamboo specimens.

  10. Beetroot Juice Improves On-Water 500 M Time-Trial Performance, and Laboratory-Based Paddling Economy in National and International-Level Kayak Athletes. (United States)

    Peeling, Peter; Cox, Gregory R; Bullock, Nicola; Burke, Louise M


    We assessed the ingestion of a beetroot juice supplement (BR) on 4-min laboratory-based kayak performance in national level male (n = 6) athletes (Study A), and on 500 m on-water kayak time-trial (TT) performance in international level female (n = 5) athletes (Study B). In Study A, participants completed three laboratory-based sessions on a kayak ergometer, including a 7 × 4 min step test, and two 4 min maximal effort performance trials. Two and a half hours before the warm-up of each 4 min performance trial, athletes received either a 70 ml BR shot containing ~4.8 mmol of nitrate, or a placebo equivalent (BRPLA). The distance covered over the 4 min TT was not different between conditions; however, the average VO2 over the 4 min period was significantly lower in BR (p = .04), resulting in an improved exercise economy (p = .05). In Study B, participants completed two field-based 500 m TTs, separated by 4 days. Two hours before each trial, athletes received either two 70 ml BR shots containing ~9.6 mmol of nitrate, or a placebo equivalent (BRPLA). BR supplementation significantly enhanced TT performance by 1.7% (p = .01). Our results show that in national-level male kayak athletes, commercially available BR shots (70 ml) containing ~4.8 mmol of nitrate improved exercise economy during laboratory-based tasks predominantly reliant on the aerobic energy system. Furthermore, greater volumes of BR (140 ml; ~9.6 mmol nitrate) provided to international-level female kayak athletes resulted in enhancements to TT performance in the field.

  11. Reducing communication delays and improving quality of care with a tuberculosis laboratory information system in resource poor environments: a cluster randomized controlled trial. (United States)

    Blaya, Joaquín A; Shin, Sonya S; Yagui, Martin; Contreras, Carmen; Cegielski, Peter; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Bayona, Jaime; Kim, Jihoon; Fraser, Hamish S F


    Lost, delayed or incorrect laboratory results are associated with delays in initiating treatment. Delays in treatment for Multi-Drug Resistant Tuberculosis (MDR-TB) can worsen patient outcomes and increase transmission. The objective of this study was to evaluate the impact of a laboratory information system in reducing delays and the time for MDR-TB patients to culture convert (stop transmitting). 78 primary Health Centers (HCs) in Lima, Peru. Participants lived within the catchment area of participating HCs and had at least one MDR-TB risk factor. The study design was a cluster randomized controlled trial with baseline data. The intervention was the e-Chasqui web-based laboratory information system. Main outcome measures were: times to communicate a result; to start or change a patient's treatment; and for that patient to culture convert. 1671 patients were enrolled. Intervention HCs took significantly less time to receive drug susceptibility test (DST) (median 11 vs. 17 days, Hazard Ratio 0.67 [0.62-0.72]) and culture (5 vs. 8 days, 0.68 [0.65-0.72]) results. The time to treatment was not significantly different, but patients in intervention HCs took 16 days (20%) less time to culture convert (p = 0.047). The eChasqui system reduced the time to communicate results between laboratories and HCs and time to culture conversion. It is now used in over 259 HCs covering 4.1 million people. This is the first randomized controlled trial of a laboratory information system in a developing country for any disease and the only study worldwide to show clinical impact of such a system. NCT01201941.

  12. Selection criteria limit generalizability of smoking pharmacotherapy studies differentially across clinical trials and laboratory studies: A systematic review on varenicline. (United States)

    Motschman, Courtney A; Gass, Julie C; Wray, Jennifer M; Germeroth, Lisa J; Schlienz, Nicolas J; Munoz, Diana A; Moore, Faith E; Rhodes, Jessica D; Hawk, Larry W; Tiffany, Stephen T


    The selection criteria used in clinical trials for smoking cessation and in laboratory studies that seek to understand mechanisms responsible for treatment outcomes may limit their generalizability to one another and to the general population. We reviewed studies on varenicline versus placebo and compared eligibility criteria and participant characteristics of clinical trials (N=23) and laboratory studies (N=22) across study type and to nationally representative survey data on adult, daily USA smokers (2014 National Health Interview Survey; 2014 National Survey on Drug Use and Health). Relative to laboratory studies, clinical trials more commonly reported excluding smokers who were unmotivated to quit and for specific medical conditions (e.g., cardiovascular disease, COPD), although both study types frequently reported excluding for general medical or psychiatric reasons. Laboratory versus clinical samples smoked less, had lower nicotine dependence, were younger, and more homogeneous with respect to smoking level and nicotine dependence. Application of common eligibility criteria to national survey data resulted in considerable elimination of the daily-smoking population for both clinical trials (≥47%) and laboratory studies (≥39%). Relative to the target population, studies in this review recruited participants who smoked considerably more and had a later smoking onset age, and were under-representative of Caucasians. Results suggest that selection criteria of varenicline studies limit generalizability in meaningful ways, and differences in criteria across study type may undermine efforts at translational research. Recommendations for improvements in participant selection and reporting standards are discussed. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  13. Pretreating dogwood seedlings with simulated acidic precipitation increases dogwood anthracnose symptoms in greenhouse-laboratory trials

    Energy Technology Data Exchange (ETDEWEB)

    Anderson, R.L.; Knighten, J. (USDA Forest Service, Resistance Screening Center, Asheville, NC (United States)); Berrange, P.; Lawton, K.A. (USDA Forest Service, Center for Forest Environmental Studies, Dry Branch, GA (United States)); Britton, K.O. (USDA Forest Service, Southeastern Forest Experiment Station, Athens, GA (United States))


    Dogwood anthracnose is the most damaging disease of flowering dogwood (Cornus florida L.) in a large part of the tree's natural range. It is caused by Discula destructiva infection. Previous attempts to inoculate C. florida to produce anthracnose symptoms have met with limited success except when the leaves were pretreated with acidic water, suggesting that acidic precipitation may predispose dogwoods to the disease. This hypothesis was tested in two greenhouse-laboratory studies in which year-old C. florida seedlings were randomly assigned to four treatments of simulated rain (pH 2.5, 3.5, 4.5, and 5.5) in 1989 and 1990. After 10 applications over a 42-d period, the seedlings were moved to a temperature-controlled laboratory, placed in plastic bags, humidified, and sprayed with a spore suspension of five D. destructiva isolates. About 30 d layter, the seedlings were examined for the percentage of leaves exhibiting anthracnose symptoms and disease severity on affected leaves. Both trials showed that as the acidity of the simulated rain increased, the incidence and severity of anthracnose leaf symptoms increased. The 1989 study included a soil lime treatment that showed the same trend but the overall occurrence and severity of symptoms was higher. 17 refs., 5 tabs.

  14. Forensic analysis of explosives using isotope ratio mass spectrometry (IRMS)--part 2: forensic inter-laboratory trial: bulk carbon and nitrogen stable isotopes in a range of chemical compounds (Australia and New Zealand). (United States)

    Benson, Sarah J; Lennard, Christopher J; Maynard, Philip; Hill, David M; Andrew, Anita S; Neal, Ken; Stuart-Williams, Hilary; Hope, Janet; Walker, G Stewart; Roux, Claude


    Comparability of data over time and between laboratories is a key issue for consideration in the development of global databases, and more broadly for quality assurance in general. One mechanism that can be utilized for evaluating traceability is an inter-laboratory trial. This paper addresses an inter-laboratory trial conducted across a number of Australian and New Zealand isotope ratio mass spectrometry (IRMS) laboratories. The main objective of this trial was to determine whether IRMS laboratories in these countries would record comparable values for the distributed samples. Four carbon containing and four nitrogen containing compounds were distributed to seven laboratories in Australia and one in New Zealand. The laboratories were requested to analyze the samples using their standard procedures. The data from each laboratory was evaluated collectively using International Standard ISO 13528 (Statistical methods for use in proficiency testing by inter-laboratory comparisons). "Warning signals" were raised against one participant in this trial. "Action signals" requiring corrective action were raised against four participants. These participants reviewed the data and possible sources for the discrepancies. This inter-laboratory trial was successful in providing an initial snapshot of the potential for traceability between the participating laboratories. The statistical methods described in this article could be used as a model for others needing to evaluate stable isotope results derived from multiple laboratories, e.g., inter-laboratory trials/proficiency testing. Ongoing trials will be conducted to improve traceability across the Australian and New Zealand IRMS community.

  15. Electronic laboratory system reduces errors in National Tuberculosis Program: a cluster randomized controlled trial. (United States)

    Blaya, J A; Shin, S S; Yale, G; Suarez, C; Asencios, L; Contreras, C; Rodriguez, P; Kim, J; Cegielski, P; Fraser, H S F


    To evaluate the impact of the e-Chasqui laboratory information system in reducing reporting errors compared to the current paper system. Cluster randomized controlled trial in 76 health centers (HCs) between 2004 and 2008. Baseline data were collected every 4 months for 12 months. HCs were then randomly assigned to intervention (e-Chasqui) or control (paper). Further data were collected for the same months the following year. Comparisons were made between intervention and control HCs, and before and after the intervention. Intervention HCs had respectively 82% and 87% fewer errors in reporting results for drug susceptibility tests (2.1% vs. 11.9%, P = 0.001, OR 0.17, 95%CI 0.09-0.31) and cultures (2.0% vs. 15.1%, P Chasqui users sent on average three electronic error reports per week to the laboratories. e-Chasqui reduced the number of missing laboratory results at point-of-care health centers. Clinical users confirmed viewing electronic results not available on paper. Reporting errors to the laboratory using e-Chasqui promoted continuous quality improvement. The e-Chasqui laboratory information system is an important part of laboratory infrastructure improvements to support multidrug-resistant tuberculosis care in Peru.

  16. Inter-laboratory ring trial to evaluate real-time reverse transcription polymerase chain reaction methods used for detection of infectious pancreatic necrosis virus in Chile

    Directory of Open Access Journals (Sweden)

    David Tapia


    Conclusions: Overall, the ring trial showed high values of sensitivity and specificity, with some problems of repeatability and inter-laboratory variability. This last issue needs to be addressed in order to allow harmonized diagnostic of IPNV within the country. We recommend the use of the NRL methods as validated and reliable qRT-PCR protocols for the detection of IPNV.

  17. New method for rearing Spodoptera frugiperda in laboratory shows that larval cannibalism is not obligatory

    Directory of Open Access Journals (Sweden)

    Cherre Sade Bezerra Da Silva


    Full Text Available New method for rearing Spodoptera frugiperda in laboratory shows that larval cannibalism is not obligatory. Here we show, for the first time, that larvae of the fall armyworm (FAW, Spodoptera frugiperda (Lepidoptera, Noctuidae, can be successfully reared in a cohort-based manner with virtually no cannibalism. FAW larvae were reared since the second instar to pupation in rectangular plastic containers containing 40 individuals with a surprisingly ca. 90% larval survivorship. Adult females from the cohort-based method showed fecundity similar to that already reported on literature for larvae reared individually, and fertility higher than 99%, with the advantage of combining economy of time, space and material resources. These findings suggest that the factors affecting cannibalism of FAW larvae in laboratory rearings need to be reevaluated, whilst the new technique also show potential to increase the efficiency of both small and mass FAW rearings.

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

    NARCIS (Netherlands)

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


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

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

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


    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.

  20. A Step Forward in Molecular Diagnostics of Lyssaviruses – Results of a Ring Trial among European Laboratories

    DEFF Research Database (Denmark)

    Fischer, Melina; Wernike, Kerstin; Freuling, Conrad M.


    Rabies is a lethal and notifiable zoonotic disease for which diagnostics have to meet the highest standards. In recent years, an evolution was especially seen in molecular diagnostics with a wide variety of different detection methods published. Therefore, a first international ring trial...... participants were asked to investigate a panel of defined lyssavirus RNAs, consisting of Rabies virus (RABV) and European bat lyssavirus 1 and 2 (EBLV-1 and -2) RNA samples, with systems available in their laboratory. The ring trial allowed the important conclusion that conventional RT-PCR assays were really...

  1. Laboratory-scale trials of electrolytic treatment on industrial wastewaters: microbiological aspects. (United States)

    Zanardini, E; Valle, A; Gigliotti, C; Papagno, G; Ranalli, G; Sorlini, C


    Animal, civil and industrial waste matter is a source of potential chemical, microbiological and air pollutants. In populated areas the presence of faecal bacteria and the production of malodorous compounds during waste storage and in the tanks of wastewater treatment plants, can cause concern. The general aim of the work was to study electrolytic waste treatment (recently applied on animal slurry) using low electric current across graphite and copper electrodes, determining its effect on the microflora of sludge, collected from the equalisation basin of an industrial aerobic wastewater treatment plant, and on odour emission abatement. Biochemical and enzymatic indicators like ATP content and a pool of 19 enzymatic activities were tested, comparing them with viable cell counts by traditional microbiological methods, to verify the validity of such indicators in monitoring the electrolytic treatment and to assess their correlation with odour reduction. The preliminary results of our laboratory-scale trials showed that in the presence of inert electrodes, such as graphite, metabolic activity is stimulated, whereas with copper electrodes the ATP content and some enzymatic activities are inhibited quite considerably after only four days, this being accompanied by a marked reduction in odour. Consideration was also given to the total copper released from the electrodes and its recovery using iron electrodes.

  2. Angiographic core laboratory reproducibility analyses: implications for planning clinical trials using coronary angiography and left ventriculography end-points. (United States)

    Steigen, Terje K; Claudio, Cheryl; Abbott, David; Schulzer, Michael; Burton, Jeff; Tymchak, Wayne; Buller, Christopher E; John Mancini, G B


    To assess reproducibility of core laboratory performance and impact on sample size calculations. Little information exists about overall reproducibility of core laboratories in contradistinction to performance of individual technicians. Also, qualitative parameters are being adjudicated increasingly as either primary or secondary end-points. The comparative impact of using diverse indexes on sample sizes has not been previously reported. We compared initial and repeat assessments of five quantitative parameters [e.g., minimum lumen diameter (MLD), ejection fraction (EF), etc.] and six qualitative parameters [e.g., TIMI myocardial perfusion grade (TMPG) or thrombus grade (TTG), etc.], as performed by differing technicians and separated by a year or more. Sample sizes were calculated from these results. TMPG and TTG were also adjudicated by a second core laboratory. MLD and EF were the most reproducible, yielding the smallest sample size calculations, whereas percent diameter stenosis and centerline wall motion require substantially larger trials. Of the qualitative parameters, all except TIMI flow grade gave reproducibility characteristics yielding sample sizes of many 100's of patients. Reproducibility of TMPG and TTG was only moderately good both within and between core laboratories, underscoring an intrinsic difficulty in assessing these. Core laboratories can be shown to provide reproducibility performance that is comparable to performance commonly ascribed to individual technicians. The differences in reproducibility yield huge differences in sample size when comparing quantitative and qualitative parameters. TMPG and TTG are intrinsically difficult to assess and conclusions based on these parameters should arise only from very large trials.

  3. Laboratory trials to infect insects and nematodes by some acaropathogenic Hirsutella strains (Mycota: Clavicipitaceous anamorphs). (United States)

    Bałazy, Stanisław; Wrzosek, Marta; Sosnowska, Danuta; Tkaczuk, Cezary; Muszewska, Anna


    Laboratory assays have been carried out to artificially infect insect larvae of the birch bark-beetle (Scolytus ratzeburgi Jans.-Coleoptera, Scolytidae) and codling moth Cydia pomonella L. -Lepidoptera, Tortricidae) as well as the potato cyst nematode-Globodera rostochiensis Wollenweber, sugar beet nematode-Heterodera schachtii Schmidt and root-knot nematode-Meloidogyne hapla Chif (Nematoda, Heteroderidae), by the phialoconidia of some fungal species of the genus Hirsutella. From among four species tested on insects only H. nodulosa Petch infected about 20% of S. ratzeburgi larvae, whereas H. kirchneri (Rostrup) Minter, Brady et Hall, H. minnesotensis Chen, Liu et Chen, and H. rostrata Bałazy et Wiśniewski did not affect insect larvae. Only single eggs of the root-knot nematode were infected by H. minnesotensis in the laboratory trials, whereas its larvae remained unaffected. No infection cases of the potato cyst nematode (G. rostochiensis) and sugar beet nematode eggs were obtained. Comparisons of DNA-ITS-region sequences of the investigated strains with GenBank data showed no differences between H. minnesotensis isolates from the nematodes Heterodera glycines Ichinohe and from tarsonemid mites (authors' isolate). A fragment of ITS 2 with the sequence characteristic only for H. minnesotensis was selected. Two cluster analyses indicated close similarity of this species to H. thompsonii as sister clades, but the latter appeared more heterogenous. Insect and mite pathogenic species H. nodulosa localizes close to specialized aphid pathogen H. aphidis, whereas the phytophagous mite pathogens H. kirchneri and H. gregis form a separate sister clade. Hirsutella rostrata does not show remarkable relations to the establishment of aforementioned groups. Interrelated considerations on the morphology, biology and DNA sequencing of investigated Hirsutella species state their identification more precisely and facilitate the establishment of systematic positions.

  4. Test Production of Anti-Corrosive Paint in Laboratory Scale

    International Nuclear Information System (INIS)

    Thein Thein Win, Daw; Khin Aye Tint, Daw; Wai Min Than, Daw


    The main purpose of this project is to produce the anti-corrosive paint in laboratory scale. In these experiments, local raw materials, natural resin (shellac), pine oil, turpentine and ethyl alcohol wer applied basically. Laboratory trials were undrtaken to determine the suitablity of raw materials ane their composition for anti-corrosive paint manufacture.The results obtained show that the anti-corrosive paint from experiment No.(30) is suitable for steel plate and this is also considered commercially economics

  5. Impact of providing fee data on laboratory test ordering: a controlled clinical trial. (United States)

    Feldman, Leonard S; Shihab, Hasan M; Thiemann, David; Yeh, Hsin-Chieh; Ardolino, Margaret; Mandell, Steven; Brotman, Daniel J


    Inpatient care providers often order laboratory tests without any appreciation for the costs of the tests. To determine whether we could decrease the number of laboratory tests ordered by presenting providers with test fees at the time of order entry in a tertiary care hospital, without adding extra steps to the ordering process. Controlled clinical trial. Tertiary care hospital. All providers, including physicians and nonphysicians, who ordered laboratory tests through the computerized provider order entry system at The Johns Hopkins Hospital. We randomly assigned 61 diagnostic laboratory tests to an "active" arm (fee displayed) or to a control arm (fee not displayed). During a 6-month baseline period (November 10, 2008, through May 9, 2009), we did not display any fee data. During a 6-month intervention period 1 year later (November 10, 2009, through May 9, 2010), we displayed fees, based on the Medicare allowable fee, for active tests only. We examined changes in the total number of orders placed, the frequency of ordered tests (per patient-day), and total charges associated with the orders according to the time period (baseline vs intervention period) and by study group (active test vs control). For the active arm tests, rates of test ordering were reduced from 3.72 tests per patient-day in the baseline period to 3.40 tests per patient-day in the intervention period (8.59% decrease; 95% CI, -8.99% to -8.19%). For control arm tests, ordering increased from 1.15 to 1.22 tests per patient-day from the baseline period to the intervention period (5.64% increase; 95% CI, 4.90% to 6.39%) (P fee data to providers at the time of order entry resulted in a modest decrease in test ordering. Adoption of this intervention may reduce the number of inappropriately ordered diagnostic tests.


    Directory of Open Access Journals (Sweden)

    Ewen McLean


    Full Text Available The feasibility of totally replacing the fishmeal component of marine shrimp (Litopenaeus vannamei diets was examined both in the laboratory setting and during a full–scale commercial trial. Animals were fed either a traditional fishmeal–based diet or one in which complete replacement of fishmeal, on a per protein basis, was manufactured using a yeast–based product, NuPro®. Laboratory studies determined that irrespective of diet fed, no difference in shrimp performance (weight gain, survival and SGR occurred. A field trial was thus activated to determine whether lab–scale studies were transferable to the commercial setting. Trials were conducted in earthen ponds from mid–June to early November 2005. Ponds were initially stocked with PL12–16 shrimp at a rate of 100,000 per hectare. At trial end, ponds receiving the NuPro®–based feed had equivalent growth to that of shrimp fed the traditional, fishmeal–based diet. Percent increase in weight from initial values and survival for the NuPro® ponds was 296, 269 and 275%, and 78, 76 and 85% respectively, whereas that for the fishmeal–based diet was 305% and 80% respectively. Noteworthy was that within pond size variation of L. vannamei was lower in NuPro® fed animals (±2.3 g when compared against animals receiving the traditional feed (±4.1 g. Overall observations from the field trial indicate the importance of the »bioreactor« pond with respect to the supply of energy to sustain shrimp growth potential.

  7. Operational trials of single- and multi-element CR-39 dosemeters for the DIDO and PLUTO reactors at the Harwell Laboratory

    International Nuclear Information System (INIS)

    Gallacher, G.G.; Perks, C.A.


    Single- and multi-element CR-39 dosemeters, developed at the Harwell Laboratory, and a commercially available multi-element CR-39 dosemeter (obtained from Track Analysis Systems Ltd), were evaluated for their potential as neutron dosemeters for personnel working at Harwell Laboratory's research reactors. Owing to the angular dependence of the CR-39 (processed using electrochemical etching), the single-element dosemeter was found to be impractical. Consequently, a multi-element dosemeter was developed, which consisted of a cube of side 36 mm with CR-39 elements (also processed using electrochemical etching) attached to each of the sides. Although this dosemeter was technically suitable for this type of dosimetry, it was considered to be unacceptably bulky in personnel trials. The commercially available CR-39 dosemeter tested was much smaller (the CR-39 was only chemically etched) and this was considered to be acceptable as a personnel dosemeter. In addition, trials with personnel working at active handling glove boxes indicated that single-element dosemeters might be adequate, but further work would be needed to verify this. (author)

  8. Using pathology-specific laboratory profiles in Clinical Pathology to reduce inappropriate test requesting: two completed audit cycles (United States)


    Background Systematic reviews have shown that, although well prepared, the Consensus Guidelines have failed to change clinical practice. In the healthcare district of Castelnovo né Monti (Reggio Emilia, Italy), it became necessary for the GPs and Clinical Pathologists to work together to jointly define laboratory profiles. Methods Observational study with two cycles of retrospective audit on test request forms, in a primary care setting. Objectives of the study were to develop pathology-specific laboratory profiles and to increase the number of provisional diagnoses on laboratory test request forms. A Multiprofessional Multidisciplinary Inter-hospital Work Team developed pathology-specific laboratory profiles for more effective test requesting. After 8 training sessions that used a combined strategy with multifaceted interventions, the 23 General Practitioners (GPs) in the trial district (Castelnovo nè Monti) tested the profiles; the 21 GPs in the Puianello district were the control group; all GPs in both districts participated in the trial. All laboratory tests for both healthcare districts are performed at the Laboratory located in the trial district. A baseline and a 1-year audit were performed in both districts on the GPs’ request forms. Results Seven pathology-specific laboratory profiles for outpatients were developed. In the year after the first audit cycle: 1) the number of tests requested in the trial district was distinctly lower than that in the previous year, with a decrease of about 5% (p < 0.001); 2) the provisional diagnosis on the request forms was 52.8% in the trial district and 42% in the control district (P < 0.001); 3) the decrease of the number of tests on each request form was much more marked in the trial district (8.73 vs. 10.77; p < 0.001). Conclusions The first audit cycle showed a significant decrease in the number of tests ordered only in the trial district. The combined strategy used in this study improved the

  9. A Six Sigma Trial For Reduction of Error Rates in Pathology Laboratory. (United States)

    Tosuner, Zeynep; Gücin, Zühal; Kiran, Tuğçe; Büyükpinarbaşili, Nur; Turna, Seval; Taşkiran, Olcay; Arici, Dilek Sema


    A major target of quality assurance is the minimization of error rates in order to enhance patient safety. Six Sigma is a method targeting zero error (3.4 errors per million events) used in industry. The five main principles of Six Sigma are defining, measuring, analysis, improvement and control. Using this methodology, the causes of errors can be examined and process improvement strategies can be identified. The aim of our study was to evaluate the utility of Six Sigma methodology in error reduction in our pathology laboratory. The errors encountered between April 2014 and April 2015 were recorded by the pathology personnel. Error follow-up forms were examined by the quality control supervisor, administrative supervisor and the head of the department. Using Six Sigma methodology, the rate of errors was measured monthly and the distribution of errors at the preanalytic, analytic and postanalytical phases was analysed. Improvement strategies were reclaimed in the monthly intradepartmental meetings and the control of the units with high error rates was provided. Fifty-six (52.4%) of 107 recorded errors in total were at the pre-analytic phase. Forty-five errors (42%) were recorded as analytical and 6 errors (5.6%) as post-analytical. Two of the 45 errors were major irrevocable errors. The error rate was 6.8 per million in the first half of the year and 1.3 per million in the second half, decreasing by 79.77%. The Six Sigma trial in our pathology laboratory provided the reduction of the error rates mainly in the pre-analytic and analytic phases.

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

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


    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.

  11. Sample requirements and design of an inter-laboratory trial for radiocarbon laboratories

    International Nuclear Information System (INIS)

    Bryant, Charlotte; Carmi, Israel; Cook, Gordon; Gulliksen, Steinar; Harkness, Doug; Heinemeier, Jan; McGee, Edward; Naysmith, Philip; Possnert, Goran; Scott, Marian; Plicht, Hans van der; Strydonck, Mark van


    An on-going inter-comparison programme which is focused on assessing and establishing consensus protocols to be applied in the identification, selection and sub-sampling of materials for subsequent 14 C analysis is described. The outcome of the programme will provide a detailed quantification of the uncertainties associated with 14 C measurements including the issues of accuracy and precision. Such projects have become recognised as a fundamental aspect of continuing laboratory quality assurance schemes, providing a mechanism for the harmonisation of measurements and for demonstrating the traceability of results. The design of this study and its rationale are described. In summary, a suite of core samples has been defined which will be made available to both AMS and radiometric laboratories. These core materials are representative of routinely dated material and their ages span the full range of the applied 14 C time-scale. Two of the samples are of wood from the German and Irish dendrochronologies, thus providing a direct connection to the master dendrochronological calibration curve. Further samples link this new inter-comparison to past studies. Sample size and precision have been identified as being of paramount importance in defining dating confidence, and so several core samples have been identified for more in-depth study of these practical issues. In addition to the core samples, optional samples have been identified and prepared specifically for either AMS and/or radiometric laboratories. For AMS laboratories, these include bone, textile, leather and parchment samples. Participation in the study requires a commitment to a minimum of 10 core analyses, with results to be returned within a year

  12. TAILORx Trial Shows Some Women with Breast Cancer May Forgo Chemotherapy (United States)

    A summary of results from the Trial Assigning Individualized Options for Treatment, or TAILORx, finds that women with early-stage hormone receptor-positive breast cancer have a low risk of recurrence based on a test for the expression of 21 genes.

  13. Safety in the Chemical Laboratory (United States)

    Steere, Norman V., Ed.


    Suggests laboratory instructors preserve the necessary evidence after an incident in classroom. Included is a checklist for gathering evidence that trial lawyers will need to present defense adequately. (CC)

  14. Performance of laboratories analysing welding fume on filter samples: results from the WASP proficiency testing scheme. (United States)

    Stacey, Peter; Butler, Owen


    This paper emphasizes the need for occupational hygiene professionals to require evidence of the quality of welding fume data from analytical laboratories. The measurement of metals in welding fume using atomic spectrometric techniques is a complex analysis often requiring specialist digestion procedures. The results from a trial programme testing the proficiency of laboratories in the Workplace Analysis Scheme for Proficiency (WASP) to measure potentially harmful metals in several different types of welding fume showed that most laboratories underestimated the mass of analyte on the filters. The average recovery was 70-80% of the target value and >20% of reported recoveries for some of the more difficult welding fume matrices were welding fume trial filter samples. Consistent rather than erratic error predominated, suggesting that the main analytical factor contributing to the differences between the target values and results was the effectiveness of the sample preparation procedures used by participating laboratories. It is concluded that, with practice and regular participation in WASP, performance can improve over time.

  15. Novel assessment tools to evaluate clinical and laboratory responses in a subset of patients enrolled in the Rituximab in Myositis trial. (United States)

    Rider, Lisa G; Yip, Adrienne L; Horkayne-Szakaly, Iren; Volochayev, Rita; Shrader, Joseph A; Turner, Maria L; Kong, Heidi H; Jain, Minal S; Jansen, Anna V; Oddis, Chester V; Fleisher, Thomas A; Miller, Frederick W


    We aimed to assess changes in myositis core set measures and ancillary clinical and laboratory data from the National Institutes of Health's subset of patients enrolled in the Rituximab in Myositis trial. Eighteen patients (5 dermatomyositis, 8 polymyositis, 5 juvenile dermatomyositis) completed more in-depth testing of muscle strength and cutaneous assessments, patient-reported outcomes, and laboratory tests before and after administration of rituximab. Percentage change in individual measures and in the definitions of improvement (DOIs) and standardized response means were examined over 44 weeks. Core set activity measures improved by 18-70% from weeks 0-44 and were sensitive to change. Fifteen patients met the DOI at week 44, 9 patients met a DOI 50% response, and 4 met a DOI 70% response. Muscle strength and function measures were more sensitive to change than cutaneous assessments. Constitutional, gastrointestinal, and pulmonary systems improved 44-70%. Patient-reported outcomes improved up to 28%. CD20+ B cells were depleted in the periphery, but B cell depletion was not associated with clinical improvement at week 16. This subset of patients had high rates of clinical response to rituximab, similar to patients in the overall trial. Most measures were responsive, and muscle strength had a greater degree of change than cutaneous assessments. Several novel assessment tools, including measures of strength and function, extra-muscular organ activity, fatigue, and health-related quality of life, are promising for use in future myositis trials. Further study of B cell-depleting therapies in myositis, particularly in treatment-naïve patients, is warranted.

  16. Full impact of laboratory information system requires direct use by clinical staff: cluster randomized controlled trial. (United States)

    Blaya, Joaquín A; Shin, Sonya; Contreras, Carmen; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Kim, Jihoon; Rodriguez, Pablo; Cegielski, Peter; Fraser, Hamish S F


    To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system. Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs. For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p60 days to arrive (pChasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting.

  17. Promoting Good Clinical Laboratory Practices and Laboratory Accreditation to Support Clinical Trials in Sub-Saharan Africa (United States)

    Shott, Joseph P.; Saye, Renion; Diakité, Moussa L.; Sanogo, Sintry; Dembele, Moussa B.; Keita, Sekouba; Nagel, Mary C.; Ellis, Ruth D.; Aebig, Joan A.; Diallo, Dapa A.; Doumbo, Ogobara K.


    Laboratory capacity in the developing world frequently lacks quality management systems (QMS) such as good clinical laboratory practices, proper safety precautions, and adequate facilities; impacting the ability to conduct biomedical research where it is needed most. As the regulatory climate changes globally, higher quality laboratory support is needed to protect study volunteers and to accurately assess biological parameters. The University of Bamako and its partners have undertaken a comprehensive QMS plan to improve quality and productivity using the Clinical and Laboratory Standards Institute standards and guidelines. The clinical laboratory passed the College of American Pathologists inspection in April 2010, and received full accreditation in June 2010. Our efforts to implement high-quality standards have been valuable for evaluating safety and immunogenicity of malaria vaccine candidates in Mali. Other disease-specific research groups in resource-limited settings may benefit by incorporating similar training initiatives, QMS methods, and continual improvement practices to ensure best practices. PMID:22492138

  18. Laboratory and clinical trials of cocamide diethanolamine lotion against head lice

    Directory of Open Access Journals (Sweden)

    Ian F. Burgess


    Full Text Available Context. During the late 1990s, insecticide resistance had rendered a number of treatment products ineffective; some companies saw this as an opportunity to develop alternative types of treatment. We investigated the possibility that a surfactant-based lotion containing 10% cocamide diethanolamine (cocamide DEA was effective to eliminate head louse infestation.Settings and Design. Initial in vitro testing of the lotion formulation versus laboratory reared body/clothing lice, followed by two randomised, controlled, community-based, assessor blinded, clinical studies.Materials and Methods. Preliminary laboratory tests were performed by exposing lice or louse eggs to the product using a method that mimicked the intended use. Clinical Study 1: Children and adults with confirmed head louse infestation were treated by investigators using a single application of aqueous 10% cocamide DEA lotion applied for 60 min followed by shampooing or a single 1% permethrin creme rinse treatment applied to pre-washed hair for 10 min. Clinical Study 2: Compared two treatment regimens using 10% cocamide DEA lotion that was concentrated by hair drying. A single application left on for 8 h/overnight was compared with two applications 7 days apart of 2 h duration, followed by a shampoo wash.Results. The initial laboratory tests showed a pediculicidal effect for a 60 min application but limited ovicidal effect. A longer application time of 8 h or overnight was found capable of killing all eggs but this differed between batches of test material. Clinical Study 1: Both treatments performed badly with only 3/23 (13% successful treatments using cocamide DEA and 5/25 (23.8% using permethrin. Clinical Study 2: The single overnight application of cocamide DEA concentrated by hair drying gave 10/56 (17.9% successes compared with 19/56 (33.9% for the 2 h application regimen repeated after 1 week. Intention to treat analysis showed no significant difference (p = 0.0523 between the

  19. Odour reduction strategies for biosolids produced from a Western Australian wastewater treatment plant: results from Phase I laboratory trials. (United States)

    Gruchlik, Yolanta; Heitz, Anna; Joll, Cynthia; Driessen, Hanna; Fouché, Lise; Penney, Nancy; Charrois, Jeffrey W A


    This study investigated sources of odours from biosolids produced from a Western Australian wastewater treatment plant and examined possible strategies for odour reduction, specifically chemical additions and reduction of centrifuge speed on a laboratory scale. To identify the odorous compounds and assess the effectiveness of the odour reduction measures trialled in this study, headspace solid-phase microextraction gas chromatography-mass spectrometry (HS SPME-GC-MS) methods were developed. The target odour compounds included volatile sulphur compounds (e.g. dimethyl sulphide, dimethyl disulphide and dimethyl trisulphide) and other volatile organic compounds (e.g. toluene, ethylbenzene, styrene, p-cresol, indole and skatole). In our laboratory trials, aluminium sulphate added to anaerobically digested sludge prior to dewatering offered the best odour reduction strategy amongst the options that were investigated, resulting in approximately 40% reduction in the maximum concentration of the total volatile organic sulphur compounds, relative to control.

  20. Clinical Trials

    Medline Plus

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

  1. Clinical Trials

    Medline Plus

    Full Text Available ... final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists ... part in clinical trials are vital to the process of improving medical care. Many people volunteer because ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... protect patients and help produce reliable study results. Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ...

  3. A 50-year research journey. From laboratory to clinic. (United States)

    Ross, John


    Prior important research is not always cited, exemplified by Oswald Avery's pioneering discovery that DNA is the genetic transforming factor; it was not cited by Watson and Crick 10 years later. My first laboratory research (National Institutes of Health 1950s) resulted in the clinical development of transseptal left heart catheterization. Laboratory studies on cardiac muscle mechanics in normal and failing hearts led to the concept of afterload mismatch with limited preload reserve. At the University of California, San Diego in La Jolla (1968) laboratory experiments on coronary artery reperfusion after sustained coronary occlusion showed salvage of myocardial tissue, a potential treatment for acute myocardial infarction proven in clinical trials of thrombolysis 14 years later. Among 60 trainees who worked with me in La Jolla, one-third were Japanese and some of their important laboratory experiments are briefly recounted, beginning with Sasayama, Tomoike and Shirato in the 1970 s. Recently, we developed a method for cardiac gene transfer, and subsequently we showed that gene therapy for the defect in cardiomyopathic hamsters halted the progression of advanced disease. Cardiovascular research and medicine are producing continuing advances in technologies for gene transfer and embryonic stem cell transplantation, targeting of small molecules, and tissue and organ engineering.

  4. Authentication scheme for routine verification of genetically similar laboratory colonies: a trial with Anopheles gambiae

    Directory of Open Access Journals (Sweden)

    Sutcliffe Alice C


    Full Text Available Abstract Background When rearing morphologically indistinguishable laboratory strains concurrently, the threat of unintentional genetic contamination is constant. Avoidance of accidental mixing of strains is difficult due to the use of common equipment, technician error, or the possibility of self relocation by adult mosquitoes ("free fliers". In many cases, laboratory strains are difficult to distinguish because of morphological and genetic similarity, especially when laboratory colonies are isolates of certain traits from the same parental strain, such as eye color mutants, individuals with certain chromosomal arrangements or high levels of insecticide resistance. Thus, proving genetic integrity could seem incredibly time-consuming or impossible. On the other hand, lacking proof of genetically isolated laboratory strains could question the validity of research results. Results We present a method for establishing authentication matrices to routinely distinguish and confirm that laboratory strains have not become physically or genetically mixed through contamination events in the laboratory. We show a specific example with application to Anopheles gambiae sensu stricto strains at the Malaria Research and Reference Reagent Resource Center. This authentication matrix is essentially a series of tests yielding a strain-specific combination of results. Conclusion These matrix-based methodologies are useful for several mosquito and insect populations but must be specifically tailored and altered for each laboratory based on the potential contaminants available at any given time. The desired resulting authentication plan would utilize the least amount of routine effort possible while ensuring the integrity of the strains.

  5. Thermotolerant Yeast Strains Adapted by Laboratory Evolution Show Trade-Off at Ancestral Temperatures and Preadaptation to Other Stresses

    DEFF Research Database (Denmark)

    Caspeta, Luis; Nielsen, Jens


    adaptive laboratory evolution, we previously isolated seven Saccharomyces cerevisiae strains with improved growth at 40°C. Here, we show that genetic adaptations to high temperature caused a growth trade-off at ancestral temperatures, reduced cellular functions, and improved tolerance of other stresses...... in the ancestral strain. The latter is an advantageous attribute for acquiring thermotolerance and correlates with the reduction of yeast functions associated with loss of respiration capacity. This trait caused glycerol overproduction that was associated with the growth trade-off at ancestral temperatures....... In combination with altered sterol composition of cellular membranes, glycerol overproduction was also associated with yeast osmotolerance and improved tolerance of high concentrations of glucose and ethanol. Our study shows that thermal adaptation of yeast is suitable for improving yeast resistance...

  6. RTOG: Updated results of randomized trials

    International Nuclear Information System (INIS)

    Curran, Walter J.


    Objective: To review the background, rationale and available results for recently completed randomized comparative clinical trials of the Radiation Therapy Oncology Group (RTOG), including inter group trials in which the RTOG has been the managing group or a major participant. When available, laboratory studies will be correlated with clinical results

  7. Clinical and biomarker changes in premanifest Huntington disease show trial feasibility: a decade of the PREDICT-HD study

    Directory of Open Access Journals (Sweden)

    Jane S Paulsen


    Full Text Available There is growing consensus that intervention and treatment of Huntington disease (HD should occur at the earliest stage possible. Various early-intervention methods for this fatal neurodegenerative disease have been identified, but preventive clinical trials for HD are limited by a lack of knowledge of the natural history of the disease and a dearth of appropriate outcome measures. Objectives of the current study are to document the natural history of premanifest HD progression in the largest cohort ever studied and to develop a battery of imaging and clinical markers of premanifest HD progression that can be used as outcome measures in preventive clinical trials. PREDICT-HD is a 32-site, international, observational study of premanifest HD, with annual examination of 1013 participants with premanifest HD and 301 gene-expansion negative controls between 2001 and 2012. Findings document 39 variables representing imaging, motor, cognitive, functional, and psychiatric domains, showing different rates of decline between premanifest Huntington disease and controls. Required sample size and models of premanifest HD are presented to inform future design of clinical and preclinical research. Preventive clinical trials in premanifest HD with participants who have a medium or high probability of motor onset are calculated to be as resource-effective as those conducted in diagnosed HD and could interrupt disease seven to twelve years earlier. Methods and measures for preventive clinical trials in premanifest HD more than a dozen years from motor onset are also feasible. These findings represent the most thorough documentation of a clinical battery for experimental therapeutics in stages of premanifest HD, the time period for which effective intervention may provide the most positive possible outcome for patients and their families affected by this devastating disease.

  8. Safety and toxicity of saw palmetto in the CAMUS trial. (United States)

    Avins, Andrew L; Lee, Jeannette Y; Meyers, Catherine M; Barry, Michael J


    Extracts of the saw palmetto berry are used by many men in the United States as self-treatment for lower urinary tract symptoms due to benign prostatic hyperplasia. While the most recent data from double-blind clinical trials do not support efficacy superior to that of placebo, there are sparse data on saw palmetto toxicity. A total of 369 patients were randomized in the CAMUS (Complementary and Alternative Medicine for Urological Symptoms) trial, of whom 357 were included in this modified intent to treat analysis. Participants were randomized to 320, 640 and 960 mg daily of an ethanolic saw palmetto extract or to an identical-appearing placebo in an escalating manner at 6-month intervals for a total of 18 months of followup. Adverse event assessments, vital signs, and blood and urine laboratory tests were obtained at regular intervals. There were no statistically significant differences between the groups in the rates of serious or nonserious adverse events, changes in vital signs, digital prostate examination findings or study withdrawal rates. Overall, there were no significant intergroup differences in laboratory test abnormalities, while differences in individual laboratory tests were rare and small in magnitude. No evidence of significant dose-response phenomena was identified. The saw palmetto extract used in the CAMUS trial showed no evidence of toxicity at doses up to 3 times the usual clinical dose during an 18-month period. Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  9. Predicting bioremediation of hydrocarbons: Laboratory to field scale

    International Nuclear Information System (INIS)

    Diplock, E.E.; Mardlin, D.P.; Killham, K.S.; Paton, G.I.


    There are strong drivers to increasingly adopt bioremediation as an effective technique for risk reduction of hydrocarbon impacted soils. Researchers often rely solely on chemical data to assess bioremediation efficiently, without making use of the numerous biological techniques for assessing microbial performance. Where used, laboratory experiments must be effectively extrapolated to the field scale. The aim of this research was to test laboratory derived data and move to the field scale. In this research, the remediation of over thirty hydrocarbon sites was studied in the laboratory using a range of analytical techniques. At elevated concentrations, the rate of degradation was best described by respiration and the total hydrocarbon concentration in soil. The number of bacterial degraders and heterotrophs as well as quantification of the bioavailable fraction allowed an estimation of how bioremediation would progress. The response of microbial biosensors proved a useful predictor of bioremediation in the absence of other microbial data. Field-scale trials on average took three times as long to reach the same endpoint as the laboratory trial. It is essential that practitioners justify the nature and frequency of sampling when managing remediation projects and estimations can be made using laboratory derived data. The value of bioremediation will be realised when those that practice the technology can offer transparent lines of evidence to explain their decisions. - Detailed biological, chemical and physical characterisation reduces uncertainty in predicting bioremediation.

  10. ABT-773 (Abbott Laboratories). (United States)

    Lawrence, L E


    ABT-773 is a macrolide antibacterial agent under development by Abbott Laboratories and Taisho Pharmaceutical Co Ltd for the potential treatment of bacterial infection [266579]. As of February 2001, ABT-773 had entered phase III trials in the US [398274]. Japanese phase II trials were expected to commence in June 2000 and a phase II trial is being designed for respiratory infections, with Abbott expecting filing in March 2002 [360455]. The bioavailability of ABT-773 in humans is unaffected by food [383228] and in a phase I, randomized, double-blind trial in healthy males only mild adverse effects, usually affecting the gastrointestinal system, were observed [383208]. Under an agreement, Abbott and Taisho are conducting joint research to discover new compounds; Abbott will have worldwide marketing, manufacturing and supply rights (except in Japan), and Taisho will receive royalties on Abbott's sales in consideration of granted rights. In Japan, the companies will co-market any resulting compounds [266579]. ABT-773 demonstrated good activity in vitro and in vivo against Streptococcus pneumoniae and Staphylococcus aureus [383229], [383231], and was highly potent even against macrolide-resistant [382149], [382150] and invasive [383782] S pneumoniae.

  11. Extremity dosimetry trial: Devonport royal dockyard

    International Nuclear Information System (INIS)

    Kenyon, R.; Collison, R.


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

  12. Quantifying and visualizing site performance in clinical trials. (United States)

    Yang, Eric; O'Donovan, Christopher; Phillips, JodiLyn; Atkinson, Leone; Ghosh, Krishnendu; Agrafiotis, Dimitris K


    One of the keys to running a successful clinical trial is the selection of high quality clinical sites, i.e., sites that are able to enroll patients quickly, engage them on an ongoing basis to prevent drop-out, and execute the trial in strict accordance to the clinical protocol. Intuitively, the historical track record of a site is one of the strongest predictors of its future performance; however, issues such as data availability and wide differences in protocol complexity can complicate interpretation. Here, we demonstrate how operational data derived from central laboratory services can provide key insights into the performance of clinical sites and help guide operational planning and site selection for new clinical trials. Our methodology uses the metadata associated with laboratory kit shipments to clinical sites (such as trial and anonymized patient identifiers, investigator names and addresses, sample collection and shipment dates, etc.) to reconstruct the complete schedule of patient visits and derive insights about the operational performance of those sites, including screening, enrollment, and drop-out rates and other quality indicators. This information can be displayed in its raw form or normalized to enable direct comparison of site performance across studies of varied design and complexity. Leveraging Covance's market leadership in central laboratory services, we have assembled a database of operational metrics that spans more than 14,000 protocols, 1400 indications, 230,000 unique investigators, and 23 million patient visits and represents a significant fraction of all clinical trials run globally in the last few years. By analyzing this historical data, we are able to assess and compare the performance of clinical investigators across a wide range of therapeutic areas and study designs. This information can be aggregated across trials and geographies to gain further insights into country and regional trends, sometimes with surprising results. The

  13. Thermotolerant Yeast Strains Adapted by Laboratory Evolution Show Trade-Off at Ancestral Temperatures and Preadaptation to Other Stresses. (United States)

    Caspeta, Luis; Nielsen, Jens


    A major challenge for the production of ethanol from biomass-derived feedstocks is to develop yeasts that can sustain growth under the variety of inhibitory conditions present in the production process, e.g., high osmolality, high ethanol titers, and/or elevated temperatures (≥ 40 °C). Using adaptive laboratory evolution, we previously isolated seven Saccharomyces cerevisiae strains with improved growth at 40 °C. Here, we show that genetic adaptations to high temperature caused a growth trade-off at ancestral temperatures, reduced cellular functions, and improved tolerance of other stresses. Thermotolerant yeast strains showed horizontal displacement of their thermal reaction norms to higher temperatures. Hence, their optimal and maximum growth temperatures increased by about 3 °C, whereas they showed a growth trade-off at temperatures below 34 °C. Computational analysis of the physical properties of proteins showed that the lethal temperature for yeast is around 49 °C, as a large fraction of the yeast proteins denature above this temperature. Our analysis also indicated that the number of functions involved in controlling the growth rate decreased in the thermotolerant strains compared with the number in the ancestral strain. The latter is an advantageous attribute for acquiring thermotolerance and correlates with the reduction of yeast functions associated with loss of respiration capacity. This trait caused glycerol overproduction that was associated with the growth trade-off at ancestral temperatures. In combination with altered sterol composition of cellular membranes, glycerol overproduction was also associated with yeast osmotolerance and improved tolerance of high concentrations of glucose and ethanol. Our study shows that thermal adaptation of yeast is suitable for improving yeast resistance to inhibitory conditions found in industrial ethanol production processes. Yeast thermotolerance can significantly reduce the production costs of biomass

  14. Development of a Portable Motor Learning Laboratory (PoMLab). (United States)

    Takiyama, Ken; Shinya, Masahiro


    Most motor learning experiments have been conducted in a laboratory setting. In this type of setting, a huge and expensive manipulandum is frequently used, requiring a large budget and wide open space. Subjects also need to travel to the laboratory, which is a burden for them. This burden is particularly severe for patients with neurological disorders. Here, we describe the development of a novel application based on Unity3D and smart devices, e.g., smartphones or tablet devices, that can be used to conduct motor learning experiments at any time and in any place, without requiring a large budget and wide open space and without the burden of travel on subjects. We refer to our application as POrtable Motor learning LABoratory, or PoMLab. PoMLab is a multiplatform application that is available and sharable for free. We investigated whether PoMLab could be an alternative to the laboratory setting using a visuomotor rotation paradigm that causes sensory prediction error, enabling the investigation of how subjects minimize the error. In the first experiment, subjects could adapt to a constant visuomotor rotation that was abruptly applied at a specific trial. The learning curve for the first experiment could be modeled well using a state space model, a mathematical model that describes the motor leaning process. In the second experiment, subjects could adapt to a visuomotor rotation that gradually increased each trial. The subjects adapted to the gradually increasing visuomotor rotation without being aware of the visuomotor rotation. These experimental results have been reported for conventional experiments conducted in a laboratory setting, and our PoMLab application could reproduce these results. PoMLab can thus be considered an alternative to the laboratory setting. We also conducted follow-up experiments in university physical education classes. A state space model that was fit to the data obtained in the laboratory experiments could predict the learning curves

  15. Development of a Portable Motor Learning Laboratory (PoMLab.

    Directory of Open Access Journals (Sweden)

    Ken Takiyama

    Full Text Available Most motor learning experiments have been conducted in a laboratory setting. In this type of setting, a huge and expensive manipulandum is frequently used, requiring a large budget and wide open space. Subjects also need to travel to the laboratory, which is a burden for them. This burden is particularly severe for patients with neurological disorders. Here, we describe the development of a novel application based on Unity3D and smart devices, e.g., smartphones or tablet devices, that can be used to conduct motor learning experiments at any time and in any place, without requiring a large budget and wide open space and without the burden of travel on subjects. We refer to our application as POrtable Motor learning LABoratory, or PoMLab. PoMLab is a multiplatform application that is available and sharable for free. We investigated whether PoMLab could be an alternative to the laboratory setting using a visuomotor rotation paradigm that causes sensory prediction error, enabling the investigation of how subjects minimize the error. In the first experiment, subjects could adapt to a constant visuomotor rotation that was abruptly applied at a specific trial. The learning curve for the first experiment could be modeled well using a state space model, a mathematical model that describes the motor leaning process. In the second experiment, subjects could adapt to a visuomotor rotation that gradually increased each trial. The subjects adapted to the gradually increasing visuomotor rotation without being aware of the visuomotor rotation. These experimental results have been reported for conventional experiments conducted in a laboratory setting, and our PoMLab application could reproduce these results. PoMLab can thus be considered an alternative to the laboratory setting. We also conducted follow-up experiments in university physical education classes. A state space model that was fit to the data obtained in the laboratory experiments could predict the

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

    Directory of Open Access Journals (Sweden)

    Rufin eVanRullen


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


    Directory of Open Access Journals (Sweden)

    Andrew Galbraith


    Full Text Available The aim of the study was to assess the reliability of sprint performance in both field and laboratory conditions. Twenty-one male (mean ± s: 19 ± 1 years, 1.79 ± 0.07 m, 77.6 ± 7.1 kg and seventeen female team sport players (mean ± s: 21 ± 4 years, 1.68 ± 0. 07 m, 62.7 ± 4.7 kg performed a maximal 20-metre sprint running test on eight separate occasions. Four trials were conducted on a non-motorised treadmill in the laboratory; the other four were conducted outdoors on a hard-court training surface with time recorded by single-beam photocells. Trials were conducted in random order with no familiarisation prior to testing. There was a significant difference between times recorded during outdoor field trials (OFT and indoor laboratory trials (ILT using a non-motorised treadmill (3.47 ± 0.53 vs. 6.06 ±1.17s; p < 0.001. The coefficient of variation (CV for time was 2.55-4.22% for OFT and 5.1-7.2% for ILT. During ILT peak force (420.9 ± 87.7N, mean force (147.2 ± 24.7N, peak power (1376.8 ± 451.9W and mean power (514.8 ± 164.4W, and were measured. The CV for all ILT variables was highest during trial 1-2 comparison. The CV (95% confidence interval for the trial 3-4 comparison yielded: 9.4% (7.7-12. 1%, 7.9% (6.4-10.2%, 10.1% (8.2-13.1% and 6.2% (5.1-8.0% for PF, MF, PP and MP and respectively. The results indicate that reliable data can be derived for single maximal sprint measures, using fixed distance protocols. However, significant differences in time/speed over 20-m exist between field and laboratory conditions. This is primarily due to the frictional resistance in the non- motorised treadmill. Measures of force and power during ILT require at least 3 familiarisations to reduce variability in test scores

  18. Reasons for ineligibility in phase 1 and 2A HIV vaccine clinical trials at Kenya AIDS vaccine initiative (KAVI, Kenya.

    Directory of Open Access Journals (Sweden)

    Gloria S Omosa-Manyonyi


    Full Text Available With the persistent challenges towards controlling the HIV epidemic, there is an ongoing need for research into HIV vaccines and drugs. Sub-Saharan African countries--worst affected by the HIV pandemic--have participated in the conduct of clinical trials for HIV vaccines. In Kenya, the Kenya AIDS Vaccine Initiative (KAVI at the University of Nairobi has conducted HIV vaccine clinical trials since 2001.Participants were recruited after an extensive informed consent process followed by screening to determine eligibility. Screening included an assessment of risk behavior, medical history and physical examination, and if clinically healthy, laboratory testing. In the absence of locally derived laboratory reference ranges, the ranges used in these trials were derived from populations in the West.Two hundred eighty-one participants were screened between 2003 and 2006 for two clinical trials. Of these, 167 (59.4% met the inclusion/exclusion criteria. Overall, laboratory abnormalities based on the non-indigenous laboratory references used were the most frequent reasons (61.4% for ineligibility. Medical abnormalities contributed 30.7% of the total reasons for ineligibility. Based on the laboratory reference intervals now developed from East and Southern Africa, those ineligible due to laboratory abnormalities would have been 46.3%. Of the eligible participants, 18.6% declined enrollment.Participant recruitment for HIV vaccine clinical trials is a rigorous and time-consuming exercise. Over 61% of the screening exclusions in clinically healthy people were due to laboratory abnormalities. It is essential that laboratory reference ranges generated from local populations for laboratory values be used in the conduct of clinical trials to avoid unnecessary exclusion of willing participants and to avoid over-reporting of adverse events for enrolled participants.Protocol IAVI VRC V001 [1]. NCT00124007 Protocol IAVI 010 [2](registration with

  19. Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal. (United States)

    Ducar, Constance; Smith, Donna; Pinzon, Cris; Stirewalt, Michael; Cooper, Cristine; McElrath, M Juliana; Hural, John


    The HIV Vaccine Trials Network (HVTN) is a global network of 28 clinical trial sites dedicated to identifying an effective HIV vaccine. Cryopreservation of high-quality peripheral blood mononuclear cells (PBMC) is critical for the assessment of vaccine-induced cellular immune functions. The HVTN PBMC Quality Management Program is designed to ensure that viable PBMC are processed, stored and shipped for clinical trial assays from all HVTN clinical trial sites. The program has evolved by developing and incorporating best practices for laboratory and specimen quality and implementing automated, web-based tools. These tools allow the site-affiliated processing laboratories and the central Laboratory Operations Unit to rapidly collect, analyze and report PBMC quality data. The HVTN PBMC Quality Management Program includes five key components: 1) Laboratory Assessment, 2) PBMC Training and Certification, 3) Internal Quality Control, 4) External Quality Control (EQC), and 5) Assay Specimen Quality Control. Fresh PBMC processing data is uploaded from each clinical site processing laboratory to a central HVTN Statistical and Data Management Center database for access and analysis on a web portal. Samples are thawed at a central laboratory for assay or specimen quality control and sample quality data is uploaded directly to the database by the central laboratory. Four year cumulative data covering 23,477 blood draws reveals an average fresh PBMC yield of 1.45×10(6)±0.48 cells per milliliter of useable whole blood. 95% of samples were within the acceptable range for fresh cell yield of 0.8-3.2×10(6) cells/ml of usable blood. Prior to full implementation of the HVTN PBMC Quality Management Program, the 2007 EQC evaluations from 10 international sites showed a mean day 2 thawed viability of 83.1% and a recovery of 67.5%. Since then, four year cumulative data covering 3338 specimens used in immunologic assays shows that 99.88% had acceptable viabilities (>66%) for use in

  20. Laboratory mechanical parameters of composite resins and their relation to fractures and wear in clinical trials-A systematic review. (United States)

    Heintze, Siegward D; Ilie, Nicoleta; Hickel, Reinhard; Reis, Alessandra; Loguercio, Alessandro; Rousson, Valentin


    To evaluate a range of mechanical parameters of composite resins and compare the data to the frequency of fractures and wear in clinical studies. Based on a search of PubMed and SCOPUS, clinical studies on posterior composite restorations were investigated with regard to bias by two independent reviewers using Cochrane Collaboration's tool for assessing risk of bias in randomized trials. The target variables were chipping and/or fracture, loss of anatomical form (wear) and a combination of both (summary clinical index). These outcomes were modelled by time and material in a linear mixed effect model including random study and experiment effects. The laboratory data from one test institute were used: flexural strength, flexural modulus, compressive strength, and fracture toughness (all after 24-h storage in distilled water). For some materials flexural strength data after aging in water/saliva/ethanol were available. Besides calculating correlations between clinical and laboratory outcomes, we explored whether a model including a laboratory predictor dichotomized at a cut-off value better predicted a clinical outcome than a linear model. A total of 74 clinical experiments from 45 studies were included involving 31 materials for which laboratory data were also available. A weak positive correlation between fracture toughness and clinical fractures was found (Spearman rho=0.34, p=0.11) in addition to a moderate and statistically significant correlation between flexural strength and clinical wear (Spearman rho=0.46, p=0.01). When excluding those studies with "high" risk of bias (n=18), the correlations were generally weaker with no statistically significant correlation. For aging in ethanol, a very strong correlation was found between flexural strength decrease and clinical index, but this finding was based on only 7 materials (Spearman rho=0.96, p=0.0001). Prediction was not consistently improved with cutoff values. Correlations between clinical and laboratory

  1. Update on Eus Diagnostics, Infection Trials and Online Slide Collection

    DEFF Research Database (Denmark)

    Boutrup, Torsten Snogdal; Fry, Christian


    Following the presentation with an update on growth and sporulation of Aphanomyces invadans, by Christian Fry at last year’s annual meeting, we have conducted a series of infection trials. These infection trials have had several functions, both to establish an infection model in our laboratory...

  2. Development of performance assessment instrument based contextual learning for measuring students laboratory skills (United States)

    Susilaningsih, E.; Khotimah, K.; Nurhayati, S.


    The assessment of laboratory skill in general hasn’t specific guideline in assessment, while the individual assessment of students during a performance and skill in performing laboratory is still not been observed and measured properly. Alternative assessment that can be used to measure student laboratory skill is use performance assessment. The purpose of this study was to determine whether the performance assessment instrument that the result of research can be used to assess basic skills student laboratory. This research was conducted by the Research and Development. The result of the data analysis performance assessment instruments developed feasible to implement and validation result 62.5 with very good categories for observation sheets laboratory skills and all of the components with the very good category. The procedure is the preliminary stages of research and development stages. Preliminary stages are divided in two, namely the field studies and literature studies. The development stages are divided into several parts, namely 1) development of the type instrument, 2) validation by an expert, 3) a limited scale trial, 4) large-scale trials and 5) implementation of the product. The instrument included in the category of effective because 26 from 29 students have very high laboratory skill and high laboratory skill. The research of performance assessment instrument is standard and can be used to assess basic skill student laboratory.

  3. Circadian phase-shifting effects of a laboratory environment: a clinical trial with bright and dim light

    Directory of Open Access Journals (Sweden)

    Elliott Jeffrey A


    Full Text Available Abstract Background Our aims were to examine the influence of different bright light schedules on mood, sleep, and circadian organization in older adults (n = 60, ages 60–79 years with insomnia and/or depression, contrasting with responses of young, healthy controls (n = 30, ages 20–40 years. Methods Volunteers were assessed for one week in their home environments. Urine was collected over two 24-hour periods to establish baseline acrophase of 6-sulphatoxymelatonin (aMT6s excretion. Immediately following home recording, volunteers spent five nights and four days in the laboratory. Sleep periods were fixed at eight hours in darkness, consistent with the volunteers' usual sleep periods. Volunteers were randomly assigned to one of three light treatments (four hours per day within the wake period: (A two hours of 3,000 lux at 1–3 hours and 13–15 hours after arising; (B four hours of 3,000 lux at 6–10 hours after arising; (C four hours of dim placebo light at 6–10 hours after arising. Lighting was 50 lux during the remainder of wakefulness. The resulting aMT6s acrophase was determined during the final 30 hours in the laboratory. Results Neither mood nor total melatonin excretion differed significantly by treatment. For the three light treatments, significant and similar phase-response plots were found, indicating that the shift in aMT6s acrophase was dependent upon the circadian time of treatment. The changes in circadian timing were not significantly correlated to changes in sleep or mood. Conclusion The trial failed to demonstrate photoperiodic effects. The results suggest that even low levels of illumination and/or fixed timing of behavior had significant phase-shifting effects.

  4. Impact of an indigenous microbial enhanced oil recovery field trial on microbial community structure in a high pour-point oil reservoir

    Energy Technology Data Exchange (ETDEWEB)

    Zhang, Fan; Zhang, Xiao-Tao; Hou, Du-Jie [China Univ. of Geosciences, Beijing (China). The Key Lab. of Marine Reservoir Evolution and Hydrocarbon Accumulation Mechanism; She, Yue-Hui [Yangtze Univ., Jingzhou, Hubei (China). College of Chemistry and Environmental Engineering; Huazhong Univ. of Science and Technology, Wuhan (China). College of Life Science and Technology; Li, Hua-Min [Beijing Bioscience Research Center (China); Shu, Fu-Chang; Wang, Zheng-Liang [Yangtze Univ., Jingzhou, Hubei (China). College of Chemistry and Environmental Engineering; Yu, Long-Jiang [Huazhong Univ. of Science and Technology, Wuhan (China). College of Life Science and Technology


    Based on preliminary investigation of microbial populations in a high pour-point oil reservoir, an indigenous microbial enhanced oil recovery (MEOR) field trial was carried out. The purpose of the study is to reveal the impact of the indigenous MEOR process on microbial community structure in the oil reservoir using 16Sr DNA clone library technique. The detailed monitoring results showed significant response of microbial communities during the field trial and large discrepancies of stimulated microorganisms in the laboratory and in the natural oil reservoir. More specifically, after nutrients injection, the original dominant populations of Petrobacter and Alishewanella in the production wells almost disappeared. The expected desirable population of Pseudomonas aeruginosa, determined by enrichment experiments in laboratory, was stimulated successfully in two wells of the five monitored wells. Unexpectedly, another potential population of Pseudomonas pseudoalcaligenes which were not detected in the enrichment culture in laboratory was stimulated in the other three monitored production wells. In this study, monitoring of microbial community displayed a comprehensive alteration of microbial populations during the field trial to remedy the deficiency of culture-dependent monitoring methods. The results would help to develop and apply more MEOR processes. (orig.)

  5. Impact of an indigenous microbial enhanced oil recovery field trial on microbial community structure in a high pour-point oil reservoir. (United States)

    Zhang, Fan; She, Yue-Hui; Li, Hua-Min; Zhang, Xiao-Tao; Shu, Fu-Chang; Wang, Zheng-Liang; Yu, Long-Jiang; Hou, Du-Jie


    Based on preliminary investigation of microbial populations in a high pour-point oil reservoir, an indigenous microbial enhanced oil recovery (MEOR) field trial was carried out. The purpose of the study is to reveal the impact of the indigenous MEOR process on microbial community structure in the oil reservoir using 16Sr DNA clone library technique. The detailed monitoring results showed significant response of microbial communities during the field trial and large discrepancies of stimulated microorganisms in the laboratory and in the natural oil reservoir. More specifically, after nutrients injection, the original dominant populations of Petrobacter and Alishewanella in the production wells almost disappeared. The expected desirable population of Pseudomonas aeruginosa, determined by enrichment experiments in laboratory, was stimulated successfully in two wells of the five monitored wells. Unexpectedly, another potential population of Pseudomonas pseudoalcaligenes which were not detected in the enrichment culture in laboratory was stimulated in the other three monitored production wells. In this study, monitoring of microbial community displayed a comprehensive alteration of microbial populations during the field trial to remedy the deficiency of culture-dependent monitoring methods. The results would help to develop and apply more MEOR processes.

  6. Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL). (United States)

    Todd, Christopher A; Sanchez, Ana M; Garcia, Ambrosia; Denny, Thomas N; Sarzotti-Kelsoe, Marcella


    The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to be made available to National Institutes of Health (NIH) researchers. As a part of this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices (GCLP) that are traditionally used for laboratories conducting endpoint assays for human clinical trials. EQAPOL adapted these guidelines to the management of proficiency testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which are specifically designed for external proficiency management. Over the first two years of the contract, the EQAPOL Oversight Laboratories received training, developed standard operating procedures and quality management practices, implemented strict quality control procedures for equipment, reagents, and documentation, and received audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL, strengthen a laboratory's ability to perform critical assays and provide quality assessments of future potential vaccines. © 2013.

  7. Transmission trials, ITS2-PCR and RAPD-PCR show identity of Toxocara canis isolates from red fox and dog. (United States)

    Epe, C; Meuwissen, M; Stoye, M; Schnieder, T


    Toxocara canis isolates from dog and from red fox were compared in transmission trials and with molecular analysis using RAPD-PCR technique and comparison of the ITS2 sequence. After oral infection of bitches with 20,000 embryonated T. canis eggs of vulpine and canine origin, the vertical transmission to pup's was examined. All animals of both groups developed typical clinical symptoms of toxocarosis. The haematological, serological, parasitological and post mortem results showed no differences between both isolates except for the infectivity of T. canis stages in mice where the fox isolate showed a significant higher infectivity than the dog isolate. The RAPD-PCR showed a similarity coefficient of 0.95, similar to the range of intraspecific variation in Toxocara cati and Toxascaris leonina specimens as outgroups. The ITS2 comparison showed a 100% identity between both isolates with no intraspecific variations. Therefore, the study shows that the fox and the dog isolate of T. canis were identical in infectivity, transmission and molecular structure; a host adaptation could not be found and the fox has to be seen as a reservoir for T. canis infections in dogs. Considering the increasing number of foxes in urban areas the importance of helminth control in dogs is stressed.

  8. Quality of diets with fludized bed combustion residue treatment: II. Swine trials

    Energy Technology Data Exchange (ETDEWEB)

    Whitsel, T.J.; Reid, R.L.; Stout, W.L.; Hern, J.L.; Bennett, O.L.

    Growing pigs (Sus scrofa domesticus) were fed for an 8-wk period in two trials on diets produced on soils treated with fluidized bed combustion residue (FBCR) or limestone. Diets contained corn (Zea mays L.) and wheat (Triticum aestivum L.) mixtures with soybean (Glycine max (L.) Merr.) meal, supplemented with vegetables, fruits, and meat. Pigs were fed ad libitum and effects of diet treatment on rate of gain, N balance, blood composition, and element composition of the carcass and organs were determined. The FBCR diet caused a decrease (P<0.05 in Trial 1, P <0.07 in Trial 2) in body weight gains of pigs, but increased (P<0.05) N retention in one trial. Blood composition was not influenced markedly by diet treatment, with small but significant differences in serum Ca, triglycerides, certain amino acids, and whole blood Pb concentrations; effects were not consistent between trials. Urinary As concentration was slightly higher for pigs on FBCR diets. Analysis of the carcass and organs of pigs slaughtered posttrial showed significant differences in element levels from those of pretrial animals, but differences in tissue mineral concentrations related to diet treatment were few and inconsistent. Element concentrations in the organs of pigs were within normal ranges. No explanation for the depression in weight gain of pigs fed FBCR-treated diets was found. Except for the weight response, results support data from other trials with laboratory animals showing no apparent adverse effects of FBCR application to soils on nutritive quality of foods. 24 refs., 1 fig., 10 tabs.

  9. Heart rate variability during acute psychosocial stress: A randomized cross-over trial of verbal and non-verbal laboratory stressors. (United States)

    Brugnera, Agostino; Zarbo, Cristina; Tarvainen, Mika P; Marchettini, Paolo; Adorni, Roberta; Compare, Angelo


    Acute psychosocial stress is typically investigated in laboratory settings using protocols with distinctive characteristics. For example, some tasks involve the action of speaking, which seems to alter Heart Rate Variability (HRV) through acute changes in respiration patterns. However, it is still unknown which task induces the strongest subjective and autonomic stress response. The present cross-over randomized trial sought to investigate the differences in perceived stress and in linear and non-linear analyses of HRV between three different verbal (Speech and Stroop) and non-verbal (Montreal Imaging Stress Task; MIST) stress tasks, in a sample of 60 healthy adults (51.7% females; mean age = 25.6 ± 3.83 years). Analyses were run controlling for respiration rates. Participants reported similar levels of perceived stress across the three tasks. However, MIST induced a stronger cardiovascular response than Speech and Stroop tasks, even after controlling for respiration rates. Finally, women reported higher levels of perceived stress and lower HRV both at rest and in response to acute psychosocial stressors, compared to men. Taken together, our results suggest the presence of gender-related differences during psychophysiological experiments on stress. They also suggest that verbal activity masked the vagal withdrawal through altered respiration patterns imposed by speaking. Therefore, our findings support the use of highly-standardized math task, such as MIST, as a valid and reliable alternative to verbal protocols during laboratory studies on stress. Copyright © 2018 Elsevier B.V. All rights reserved.

  10. 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


    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

  11. Establishing guidelines for pharmacotherapy trials in bulimia nervosa and anorexia nervosa. (United States)

    Mitchell, J E; Tareen, B; Sheehan, W; Agras, S; Brewerton, T D; Crow, S; Devlin, M; Eckert, E; Halmi, K; Herzog, D; Marcus, M; Powers, P; Stunkard, A; Walsh, B T


    This paper addresses the lack of a standard protocol for pharmacotherapy trials for patients with bulimia nervosa (BN) and anorexia nervosa (AN). Twenty-two surveys were sent to established researchers in the field of eating disorders to elicit their opinions regarding medication trials, including baseline laboratory tests, the optimal length/frequency of medication management sessions, and the information that should or should not be included in these sessions. Sixteen of 22 researchers completed and returned the survey. Their answers are the basis of the data presented. We propose a battery of screening laboratory tests for both conditions. We suggest 30-45-min initial medication management sessions in both AN and BN trials with 15-min follow-ups to be held weekly for AN subjects, and weekly for 2 weeks, then biweekly for 2 weeks, then monthly, for BN subjects. We also recommend that published trials should include explicit details of medication management. Copyright 2000 John Wiley & Sons, Inc.

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

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


    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.

  13. Theory of planned behaviour variables and objective walking behaviour do not show seasonal variation in a randomised controlled trial. (United States)

    Williams, Stefanie L; French, David P


    Longitudinal studies have shown that objectively measured walking behaviour is subject to seasonal variation, with people walking more in summer compared to winter. Seasonality therefore may have the potential to bias the results of randomised controlled trials if there are not adequate statistical or design controls. Despite this there are no studies that assess the impact of seasonality on walking behaviour in a randomised controlled trial, to quantify the extent of such bias. Further there have been no studies assessing how season impacts on the psychological predictors of walking behaviour to date. The aim of the present study was to assess seasonal differences in a) objective walking behaviour and b) Theory of Planned Behaviour (TPB) variables during a randomised controlled trial of an intervention to promote walking. 315 patients were recruited to a two-arm cluster randomised controlled trial of an intervention to promote walking in primary care. A series of repeated measures ANCOVAs were conducted to examine the effect of season on pedometer measures of walking behaviour and TPB measures, assessed immediately post-intervention and six months later. Hierarchical regression analyses were conducted to assess whether season moderated the prediction of intention and behaviour by TPB measures. There were no significant differences in time spent walking in spring/summer compared to autumn/winter. There was no significant seasonal variation in most TPB variables, although the belief that there will be good weather was significantly higher in spring/summer (F = 19.46, p behaviour, or moderate the effects of TPB variables on intention or behaviour. Seasonality does not influence objectively measured walking behaviour or psychological variables during a randomised controlled trial. Consequently physical activity behaviour outcomes in trials will not be biased by the season in which they are measured. Previous studies may have overestimated the extent of

  14. Field trials show the fertilizer value of nitrogen in irrigation water

    Directory of Open Access Journals (Sweden)

    Mike Cahn


    Full Text Available Increased regulatory activity designed to protect groundwater from degradation by nitrate-nitrogen (NO3-N is focusing attention on the efficiency of agricultural use of nitrogen (N. One area drawing scrutiny is the way in which growers consider the NO3-N concentration of irrigation water when determining N fertilizer rates. Four drip-irrigated field studies were conducted in the Salinas Valley evaluating the impact of irrigation water NO3-N concentration and irrigation efficiency on the N uptake efficiency of lettuce and broccoli crops. Irrigation with water NO3-N concentrations from 2 to 45 milligrams per liter were compared with periodic fertigation of N fertilizer. The effect of irrigation efficiency was determined by comparing an efficient (110% to 120% of crop evapotranspiration, ETc and an inefficient (160% to 200% of ETc irrigation treatment. Across these trials, NO3-N from irrigation water was at least as efficiently used as fertilizer N; the uptake efficiency of irrigation water NO3-N averaged approximately 80%, and it was not affected by NO3-N concentration or irrigation efficiency.

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

    Directory of Open Access Journals (Sweden)

    Tor Ivar Eikaas


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

  16. Laboratory-supported influenza surveillance in Victorian sentinel general practices. (United States)

    Kelly, H; Murphy, A; Leong, W; Leydon, J; Tresise, P; Gerrard, M; Chibo, D; Birch, C; Andrews, R; Catton, M


    Laboratory-supported influenza surveillance is important as part of pandemic preparedness, for identifying and isolating candidate vaccine strains, for supporting trials of anti-influenza drugs and for refining the influenza surveillance case definition in practice. This study describes the implementation of laboratory-supported influenza surveillance in Victorian sentinel general practices and provides an estimate of the proportion of patients with an influenza-like illness proven to have influenza. During 1998 and 1999, 25 sentinel general practices contributed clinical surveillance data and 16 metropolitan practices participated in laboratory surveillance. Serological, virus-antigen detection, virus culture and multiplex polymerase chain reaction procedures were used to establish the diagnosis of influenza. Two laboratories at major teaching hospitals in Melbourne provided additional data on influenza virus identification. General practice sentinel surveillance and laboratory identification of influenza provided similar data on the pattern of influenza in the community between May and September. The clinical suspicion of influenza was confirmed in 49 to 54 per cent of cases seen in general practice.

  17. Larvicidal effect of disinfectant soap on Anopheles gambiae s.s (Diptera: Culicidae) in laboratory and semifield environs. (United States)

    Mdoe, France P; Nkwengulila, Gamba; Chobu, Mariam; Lyaruu, Lucile; Gyunda, Israel L; Mbepera, Saada; Xue, Rui-De; Kweka, Eliningaya J


    Mosquito larval control using chemicals and biological agents is of paramount importance in vector population and disease incidence reduction. A commercial synthetic disinfectant soap was evaluated against larvae of Anopheles gambiae s.s. in both laboratory and semi field conditions. Five concentrations of commercial synthetic disinfectant soap (0.0001, 0.001, 0.01, 0.1 and 1%) were prepared and evaluated against third instar larvae in laboratory and semi field environments. Mortality was scored at 12, 24, 48, and 72 hrs. Each dosage had 6 replicates, having twenty 3rd instar larvae of An.gambiae s.s. In the laboratory phase, all dosages had significantly higher larval mortalities than in controls, while in semi field conditions, the dosages of 0.0001, 0.001 and 0.01% had lower mortalities than laboratory trials. In the comparison between semi field and laboratory trials, only 0.1 and 1% dosage had significant difference with more mortality in semifield conditions. Proportions of larvae that died during mortality monitoring intervals in laboratory and semi field had significant differences only at 12 hrs and 72 hrs. The findings of this study have demonstrated that the mortality of larvae caused by commercial synthetic disinfectant soap is worth further studies in open water bodies. More studies are necessary to find out the effect of sunlight on the chemistry of the synthetic disinfectant and other variables in small scale full field trials.

  18. Laboratory evaluation of commercial interferon preparations

    International Nuclear Information System (INIS)

    Schoub, B.D.; Lyons, S.F.; Crespi, M.; Chiu, M.-N.; Lomnitzer, R.


    The antiviral, antiproliferative and natural killer-cell (NKC) stimulatory activities of four commercial therapeutic interferon preparations were assayed in a laboratory. The antiviral and antiproliferative activities of each preparation were relatively similar, but an unexpectedly high NKC stimulatory activity was found in one of them. In-house determination of antiviral activity and evaluation of the antiproliferative and NKC stimulation potential of interferon preparations are essential before rational clinical trials of this agent are carried out

  19. Clinical Trials

    Medline Plus

    Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... medical strategy, treatment, or device is safe and effective for humans. These studies also may show which ...

  20. Clinical Trials

    Medline Plus

    Full Text Available ... or strategies work best for certain illnesses or groups of people. Some clinical trials show a positive result. For example, the National Heart, Lung, and Blood Institute (NHLBI) sponsored a trial of two different ...

  1. 7 CFR 1755.3 - Field trials. (United States)


    ...; (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...

  2. Lactotripeptides Show No Effect on Human Blood Pressure: Results from a double-blind randomized controlled trial

    NARCIS (Netherlands)

    Engberink, M.F.; Schouten, E.G.; Kok, F.J.; Mierlo, van L.A.J.; Brouwer, I.A.; Geleijnse, J.M.


    Milk-derived peptides with ACE-inhibiting properties may have antihypertensive effects in humans. We conducted a randomized double-blind placebo-controlled trial to examine the blood pressure lowering potential of 2 ACE-inhibiting lactotripeptides, ie, Isoleucine-Proline-Proline and

  3. Safety and Toxicity of Saw palmetto in the Complementary and Alternative Medicine for Urological Symptoms (CAMUS) Trial (United States)

    Avins, Andrew L.; Lee, Jeannette Y.; Meyers, Catherine M.; Barry, Michael J.


    Purpose Extracts of the saw palmetto berry are used by many men in the U.S. as self-treatment for lower urinary tract symptoms due to benign prostatic hyperplasia. While the most recent data from double-blind clinical trials do not support efficacy superior to that of placebo, there are few data on the toxicity of saw palmetto. Materials and Methods 369 patients were randomized in the Complementary and Alternative Medicine for Urological Symptoms (CAMUS) trial; 357 participants are included in this modified intention-to-treat analysis. Participants were randomized to 320mg, 640mg, and 960mg daily of an ethanolic saw palmetto extract or an identical-appearing placebo, in an escalating manner at 6-month intervals, for a total of 18 months follow-up. Adverse-event assessments, vital signs, and blood and urine laboratory tests were obtained at regular intervals. Results There were no statistically significant differences between groups in rates of serious or non-serious adverse events, changes in vital signs, digital prostate exam findings, or study withdrawal rates. Overall, there were no significant inter-group differences in the occurrence of laboratory-test abnormalities; differences in individual laboratory tests were uncommon and small in magnitude. No evidence of significant dose-response phenomena were identified. Conclusions The saw palmetto extract used in the CAMUS trial showed no evidence of toxicity at doses up to three times the usual clinical dose over a period of 18 months. PMID:23063633

  4. Clinical Trials

    Medline Plus

    Full Text Available ... trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ...

  5. Validation of a PCR-based method for detection of food-borne thermotolerant Campylobacters in a multicenter collaborative trial

    DEFF Research Database (Denmark)

    Josefsen, Mathilde Hartmann; Cook, N.; D'Agostino, M.


    A PCR-based method for rapid detection of food-borne thermotolerant campylobacters was evaluated through a collaborative trial with 12 laboratories testing spiked carcass rinse samples. The method showed an interlaboratory diagnostic sensitivity of 96.7% and a diagnostic specificity of 100% for c......% for chicken samples, while these values were 94.2 and 83.3%, respectively, for pig samples....

  6. Effects of laboratory housing on exploratory behaviour, novelty discrimination and spatial reference memory in a subterranean, solitary rodent, the Cape mole-rat (Georychus capensis). (United States)

    Oosthuizen, Maria Kathleen; Scheibler, Anne-Gita; Bennett, Nigel Charles; Amrein, Irmgard


    A large number of laboratory and field based studies are being carried out on mole-rats, both in our research group and others. Several studies have highlighted the development of adverse behaviours in laboratory animals and have emphasised the importance of enrichment for captive animals. Hence we were interested in evaluating how laboratory housing would affect behavioural performance in mole-rats. We investigated exploratory behaviour, the ability to discriminate between novel and familiar environments and reference memory in the solitary Cape mole-rat (Georychus capensis). Our data showed that both wild and captive animals readily explore open spaces and tunnels. Wild animals were however more active than their captive counterparts. In the Y maze two trial discrimination task, wild animals failed to discriminate between novel and familiar environments, while laboratory housed mole-rats showed preferential spatial discrimination in terms of the length of time spent in the novel arm. The performance of the laboratory and wild animals were similar when tested for reference memory in the Y maze, both groups showed a significant improvement compared to the first day, from the 3rd day onwards. Wild animals made more mistakes whereas laboratory animals were slower in completing the task. The difference in performance between wild and laboratory animals in the Y-maze may be as a result of the lower activity of the laboratory animals. Laboratory maintained Cape mole-rats show classic behaviours resulting from a lack of stimulation such as reduced activity and increased aggression. However, they do display an improved novelty discrimination compared to the wild animals. Slower locomotion rate of the laboratory animals may increase the integration time of stimuli, hence result in a more thorough inspection of the surroundings. Unlike the captive animals, wild animals show flexibility in their responses to unpredictable events, which is an important requirement under

  7. Concordance between four European centres of PET reporting criteria designed for use in multicentre trials in Hodgkin lymphoma

    DEFF Research Database (Denmark)

    Barrington, Sally F; Qian, Wendi; Somer, Edward J


    To determine if PET reporting criteria for the Response Adapted Treatment in Hodgkin Lymphoma (RATHL) trial could enable satisfactory agreement to be reached between 'core' laboratories operating in different countries.......To determine if PET reporting criteria for the Response Adapted Treatment in Hodgkin Lymphoma (RATHL) trial could enable satisfactory agreement to be reached between 'core' laboratories operating in different countries....

  8. Improving patient safety via automated laboratory-based adverse event grading. (United States)

    Niland, Joyce C; Stiller, Tracey; Neat, Jennifer; Londrc, Adina; Johnson, Dina; Pannoni, Susan


    The identification and grading of adverse events (AEs) during the conduct of clinical trials is a labor-intensive and error-prone process. This paper describes and evaluates a software tool developed by City of Hope to automate complex algorithms to assess laboratory results and identify and grade AEs. We compared AEs identified by the automated system with those previously assessed manually, to evaluate missed/misgraded AEs. We also conducted a prospective paired time assessment of automated versus manual AE assessment. We found a substantial improvement in accuracy/completeness with the automated grading tool, which identified an additional 17% of severe grade 3-4 AEs that had been missed/misgraded manually. The automated system also provided an average time saving of 5.5 min per treatment course. With 400 ongoing treatment trials at City of Hope and an average of 1800 laboratory results requiring assessment per study, the implications of these findings for patient safety are enormous.

  9. Inter-laboratory study to characterize the detection of serum antibodies against porcine epidemic diarrhoea virus. (United States)

    Strandbygaard, Bertel; Lavazza, Antonio; Lelli, Davide; Blanchard, Yannick; Grasland, Béatrice; Poder, Sophie Le; Rose, Nicolas; Steinbach, Falko; van der Poel, Wim H M; Widén, Frederik; Belsham, Graham J; Bøtner, Anette


    Porcine epidemic diarrhea virus (PEDV) has caused extensive economic losses to pig producers in many countries. It was recently introduced, for the first time, into North America and outbreaks have occurred again in multiple countries within Europe as well. To assess the properties of various diagnostic assays for the detection of PEDV infection, multiple panels of porcine sera have been shared and tested for the presence of antibodies against PEDV in an inter-laboratory ring trial. Different laboratories have used a variety of "in house" ELISAs and also one commercial assay. The sensitivity and specificity of each assay has been estimated using a Bayesian analysis applied to the ring trial results obtained with the different assays in the absence of a gold standard. Although different characteristics were found, it can be concluded that each of the assays used can detect infection of pigs at a herd level by either the early European strains of PEDV or the recently circulating strains (INDEL and non-INDEL). However, not all the assays seem suitable for demonstrating freedom from disease in a country. The results from individual animals, especially when the infection has occurred within an experimental situation, show more variation. Copyright © 2016. Published by Elsevier B.V.

  10. Effect of caffeine on cycling time-trial performance in the heat. (United States)

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


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

  11. Genetically modified organisms in food and feed : annual report 2010 of the Dutch National Reference Laboratory

    NARCIS (Netherlands)

    Scholtens-Toma, I.M.J.; Molenaar, B.; Zaaijer, S.; Voorhuijzen, M.M.; Prins, T.W.; Kok, E.J.


    This is the annual report of the Dutch National Reference Laboratory (NRL) for Genetically Modified Food and Feed (RIKILT - Institue of Food Safety). The report gives an overview of the NRL activities carried out in 2010. In 2010 RIKILT participated in one ring trial for inter laboratory validation

  12. The effect of empowerment on the self-efficacy, quality of life and clinical and laboratory indicators of patients treated with hemodialysis: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Moattari Marzieh


    Full Text Available Abstract Background Hemodialysis patients face numerous physical and psychological stresses that result in reduced health. The aim of this study is to determine the impact of an empowerment program on self-efficacy, quality of life, clinical indicators of blood pressure and interdialytic weight gain, and laboratory results in these patients. Methods This randomized, controlled trial was conducted at Boo Ali Sina Dialysis Center, Shiraz, Iran. A total of 48 hemodialysis patients participated in this study. After acquisition of informed consent, eligible patients were randomly divided into two groups, control and experimental. Pre-test data were obtained by using a demographic data form and two questionnaires for self-efficacy and quality of life. Blood pressure and interdialytic weight gain were measured. We extracted laboratory data from patients’ charts. A six-week empowerment intervention that included four individual and two group counselling sessions was performed for the experimental group. Six weeks after intervention, post-test data were obtained from both groups in the same manner as the pre-test. Data were analyzed by ANCOVA using SPSS v11.5. Results There were no statistically significant differences in demographic variables between the groups. Pre-test mean scores for self-efficacy, quality of life, blood pressure, interdialytic weight gain and laboratory results did not differ between the groups. There was a significant difference between the experimental and control groups in terms of pre-to post-intervention changes in overall self-efficacy scores, stress reduction, and decision making, in addition to overall quality of life and all dimensions included within quality of life based on this questionnaire. Additionally, the pre- to post-intervention changes in systolic/diastolic blood pressures, interdialytic weight gain, hemoglobin and hematocrit levels significantly differed between the groups. Conclusion Our study demonstrates

  13. A data grid for imaging-based clinical trials (United States)

    Zhou, Zheng; Chao, Sander S.; Lee, Jasper; Liu, Brent; Documet, Jorge; Huang, H. K.


    Clinical trials play a crucial role in testing new drugs or devices in modern medicine. Medical imaging has also become an important tool in clinical trials because images provide a unique and fast diagnosis with visual observation and quantitative assessment. A typical imaging-based clinical trial consists of: 1) A well-defined rigorous clinical trial protocol, 2) a radiology core that has a quality control mechanism, a biostatistics component, and a server for storing and distributing data and analysis results; and 3) many field sites that generate and send image studies to the radiology core. As the number of clinical trials increases, it becomes a challenge for a radiology core servicing multiple trials to have a server robust enough to administrate and quickly distribute information to participating radiologists/clinicians worldwide. The Data Grid can satisfy the aforementioned requirements of imaging based clinical trials. In this paper, we present a Data Grid architecture for imaging-based clinical trials. A Data Grid prototype has been implemented in the Image Processing and Informatics (IPI) Laboratory at the University of Southern California to test and evaluate performance in storing trial images and analysis results for a clinical trial. The implementation methodology and evaluation protocol of the Data Grid are presented.

  14. Efficacy of the RADPAD Protection Drape in Reducing Operators' Radiation Exposure in the Catheterization Laboratory: A Sham-Controlled Randomized Trial. (United States)

    Vlastra, Wieneke; Delewi, Ronak; Sjauw, Krischan D; Beijk, Marcel A; Claessen, Bimmer E; Streekstra, Geert J; Bekker, Robbert J; van Hattum, Juliette C; Wykrzykowska, Joanna J; Vis, Marije M; Koch, Karel T; de Winter, Robbert J; Piek, Jan J; Henriques, José P S


    Interventional cardiologists are increasingly exposed to radiation-induced diseases like cataract and the stochastic risk of left-sided brain tumors. The RADPAD is a sterile, disposable, lead-free shield placed on the patient with the aim to minimize operator-received scatter radiation. The objective of the trial was to examine the RADPAD's efficacy in a real-world situation. In the current, double-blind, sham-controlled, all-comer trial, patients undergoing diagnostic catheterization or percutaneous coronary interventions were randomized in a 1:1:1 ratio to a radiation absorbing shield (RADPAD), standard treatment (NOPAD), or a sham shield (SHAMPAD). The sham shield allowed testing for shield-induced radiation behavior. The primary outcome was the difference in relative exposure of the primary operator between the RADPAD and NOPAD arms and was defined as the ratio between operator's exposure (E in µSv) and patient exposure (dose area product in mGy·cm 2 ), measured per procedure. A total of 766 consecutive coronary procedures were randomized to the use of RADPAD (N=255), NOPAD (N=255), or SHAMPAD (N=256). The use of RADPAD was associated with a 20% reduction in relative operator exposure compared with that of NOPAD ( P =0.01) and a 44% relative exposure reduction compared with the use of a SHAMPAD ( P RADPAD radiation shield reduced operator radiation exposure compared with procedures with NOPAD or SHAMPAD. This study supports the routine use of RADPAD in the catheterization laboratory. URL: Unique identifier: NCT03139968. © 2017 American Heart Association, Inc.

  15. Reprioritization of failures in a system failure mode and effects analysis by decision making trial and evaluation laboratory technique

    International Nuclear Information System (INIS)

    Seyed-Hosseini, S.M.; Safaei, N.; Asgharpour, M.J.


    In this paper an effective methodology related to decision making field has been developed for reprioritization of failure modes in a system Failure Mode and Effects Analysis (FMEA) for corrective actions. The proposed methodology can cover some of inherently shortcomings of conventional Risk Priority Number (RPN) method and like. The current prioritization methods have two main deficiencies as: they have not considered indirect relations between components and are deficient for systems with many subsystems or components. The proposed method called Decision Making Trial and Evaluation Laboratory (DEMATEL) is an effective approach for analyzing relation between components of a system in respect to its type (direct/indirect) and severity. The main advantages of DEMATEL are involving indirect relations in analyze, allocating as possible as unique ranks to alternatives and clustering alternatives in large systems. The demonstrated results have shown that DEMATEL method can be an efficient, complementary and confident approach for reprioritization of failure modes in a FMEA. For verification of proposed methodology, two illustrative practical examples are solved and obtained outcomes are reported

  16. Yuma Border Patrol Area Lighting Retrofit LED System Performance in a Trial Installation – Two Years Later

    Energy Technology Data Exchange (ETDEWEB)

    Wilkerson, Andrea M. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Sullivan, Gregory P. [Efficiency Solutions, Inc, Richland, WA (United States); Davis, Robert G. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)


    Documentation of the Yuma Sector Border Patrol Area lighting LED trial demonstration continues to provide a better understanding of LED technology performance in a high ambient temperature and high solar radiation environment. Measured data at the project site showed illuminances changing more rapidly than anticipated. As previously predicted, the causes for these observed changes are mostly if not completely explained by dirt accumulation. The laboratory measurements showed not only the effect of dirt on lumen output, but also on the distribution of light exiting the luminaire.

  17. Clinical Trials

    Medline Plus

    Full Text Available ... trial found that one of the combinations worked much better than the other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI ...

  18. External quality assurance performance of clinical research laboratories in sub-saharan Africa. (United States)

    Amukele, Timothy K; Michael, Kurt; Hanes, Mary; Miller, Robert E; Jackson, J Brooks


    Patient Safety Monitoring in International Laboratories (JHU-SMILE) is a resource at Johns Hopkins University that supports and monitors laboratories in National Institutes of Health-funded international clinical trials. To determine the impact of the JHU-SMILE quality assurance scheme in sub-Saharan African laboratories, we reviewed 40 to 60 months of external quality assurance (EQA) results of the College of American Pathologists (CAP) in these laboratories. We reviewed the performance of 8 analytes: albumin, alanine aminotransferase, creatinine, sodium, WBC, hemoglobin, hematocrit, and the human immunodeficiency virus antibody rapid test. Over the 40- to 60-month observation period, the sub-Saharan laboratories had a 1.63% failure rate, which was 40% lower than the 2011 CAP-wide rate of 2.8%. Seventy-six percent of the observed EQA failures occurred in 4 of the 21 laboratories. These results demonstrate that a system of remote monitoring, feedback, and audits can support quality in low-resource settings, even in places without strong regulatory support for laboratory quality.

  19. Fracture mapping in clays: the design and application of a mobile gas geochemistry laboratory for the analysis of soil gases

    International Nuclear Information System (INIS)

    Gregory, R.G.


    Integrated soil gas analyses for helium, radon, carbon dioxide, oxygen and organic gases allow the accurate interpretation of soil gas signatures as indicators of underlying structure. The most important features observed in the patterns of soil gas behaviour are large variations over faults and fractures. Structures such as these provide channelways for fluid movement in the upper crust. The construction of a mobile gas geochemistry laboratory for the analysis of soil gases at field investigation sites, and the subsequent trials carried out to evaluate the laboratory, clearly show that the soil gas investigation technique is accurate and viable as an independent site investigation method for the study of fracturing and groundwater movement around potential waste repository sites. (author)

  20. Clinical Trials

    Medline Plus

    Full Text Available ... from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative ... safe a treatment is or how well it works. Children (aged 18 and younger) get ... legal consent for their child to take part in a clinical trial. When ...

  1. Chemical control trials against Phytophthora capsici (Leon on pepper cultivations in Morocco

    Directory of Open Access Journals (Sweden)

    Pussemier, L.


    Full Text Available Chemical control trials against Phytophthora capsici (Leon on pepper cultivations in Morocco. Pepper protection trials against collar and root rot have been undertaken under laboratory and culture conditions using Aliette (80 % of phosethylaluminium and Ridomil M 58 (10 % of metalaxyl associated to 48 % of maneb. It has been proved that, contrary to Ridomil M 58, Aliette does not protect the hostplant when the Phytophthora capsici (Leon zoospores are used as inoculum. But both fongicides are active when inoculating with a mycelian suspension. Trials undertaken under plastic glasshouses confirmed the laboratory results both with an artificial inoculation and with a natural one on contaminated soil. Only Ridomil M 58 provides satisfactory protection during the first weeks after the treatment. When disease propagation conditions are particularly favorable (permanent presence of an active inoculum source, the protection given by repeated Ridomil M 58 applications gradually disappears after a few weeks.

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

    Directory of Open Access Journals (Sweden)

    Vojtech Huser

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

  3. Measurement of HbA1c in multicentre diabetes trials - should blood samples be tested locally or sent to a central laboratory: an agreement analysis. (United States)

    Arch, Barbara N; Blair, Joanne; McKay, Andrew; Gregory, John W; Newland, Paul; Gamble, Carrol


    Glycated haemoglobin (HbA1c) is an important outcome measure in diabetes clinical trials. For multicentre designs, HbA1c can be measured locally at participating centres or by sending blood samples to a central laboratory. This study analyses the agreement between local and central measurements, using 1-year follow-up data collected in a multicentre randomised controlled trial (RCT) of newly diagnosed children with type I diabetes. HbA1c measurements were routinely analysed both locally and centrally at baseline and then at 3, 6, 9 and 12 months and the data reported in mmol/mol. Agreement was assessed by calculating the bias and 95 % limits of agreement, using the Bland-Altman analysis method. A predetermined benchmark for clinically acceptable margin of error between measurements was subjectively set as ±10 % for HbA1c. The percentage of pairs of measurements that were classified as clinically acceptable was calculated. Descriptive statistics were used to examine the agreement within centres. Treatment group was not considered. Five hundred and ninety pairs of measurement, representing 255 children and 15 trial centres across four follow-up time points, were compared. There was no significant bias: local measurements were an average of 0.16 mmol/mol (SD = 4.5, 95 % CI -0.2 to 0.5) higher than central. The 95 % limits of agreement were -8.6 to 9.0 mmol/mol (local minus central). Eighty percent of local measurements were within ±10 % of corresponding central measurements. Some trial centres were more varied in the differences observed between local and central measurements: IQRs ranging from 3 to 9 mmol/mol; none indicated systematic bias. Variation in agreement between HbA1c measurements was greater than had been expected although no overall bias was detected and standard deviations were similar. Discrepancies were present across all participating centres. These findings have implications for the comparison of standards of clinical care between centres

  4. Bonding to oxide ceramics—laboratory testing versus clinical outcome. (United States)

    Kern, Matthias


    Despite a huge number of published laboratory bonding studies on dental oxide ceramics clinical long-term studies on resin bonded oxide ceramic restorations are rare. The purpose of this review is to present the best available clinical evidence for successful bonding of dental oxide ceramic restorations. Clinical trials with resin-bonded restorations that had no or only limited mechanical retention and were made from alumina or zirconia ceramic were identified using an electronic search in PubMed database. Overall 10 publications with clinical trials could be identified. Their clinical outcome was compared with that laboratory bond strength studies. Clinical data provide strong evidence that air-abrasion at a moderate pressure in combination with using phosphate monomer containing primers and/or luting resins provide long-term durable bonding to glass-infiltrated alumina and zirconia ceramic under the humid and stressful oral conditions. As simple and clinically reliable bonding methods to oxide ceramics exist, the rationale for development of alternative bonding methods might be reconsidered especially when these methods are more time consuming or require rather complicated and/or technique sensitive procedures. Copyright © 2014 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

  5. Ring trial 2016 for Bluetongue virus detection by real-time RT-PCR in France. (United States)

    Sailleau, Corinne; Viarouge, Cyril; Breard, Emmanuel; Vitour, Damien; Zientara, Stephan


    Since the unexpected emergence of BTV-8 in Northern Europe and the incursion of BTV-8 and 1 in France in 2006-2007, molecular diagnosis has considerably evolved. Several real-time RT-PCR (rtRT-PCR) methods have been developed and published, and are currently being used in many countries across Europe for BTV detection and typing. In France, the national reference laboratory (NRL) for orbiviruses develops and validates 'ready-to-use' kits with private companies for viral RNA detection. The regional laboratories network that was set up to deal with a heavy demand for analyses has used these available kits. From 2007, ring tests were organized to monitor the performance of the French laboratories. This study presents the results of 63 regional laboratories in the ring trial organized in 2016. Blood samples were sent to the laboratories. Participants were asked to use the rtRT-PCR methods in place in their laboratory, for detection of all BTV serotypes and specifically BTV-8. The French regional laboratories are able to detect and genotype BTV in affected animals. Despite the use of several methods (i.e. RNA extraction and different commercial rtRT-PCRs), the network is homogeneous. The ring trial demonstrated that the French regional veterinary laboratories have reliable and robust BTV diagnostic tools for BTV genome detection.

  6. [Software for illustrating a cost-quality balance carried out by clinical laboratory practice]. (United States)

    Nishibori, Masahiro; Asayama, Hitoshi; Kimura, Satoshi; Takagi, Yasushi; Hagihara, Michio; Fujiwara, Mutsunori; Yoneyama, Akiko; Watanabe, Takashi


    We have no proper reference indicating the quality of clinical laboratory practice, which should clearly illustrates that better medical tests require more expenses. Japanese Society of Laboratory Medicine was concerned about recent difficult medical economy and issued a committee report proposing a guideline to evaluate the good laboratory practice. According to the guideline, we developed software that illustrate a cost-quality balance carried out by clinical laboratory practice. We encountered a number of controversial problems, for example, how to measure and weight each quality-related factor, how to calculate costs of a laboratory test and how to consider characteristics of a clinical laboratory. Consequently we finished only prototype software within the given period and the budget. In this paper, software implementation of the guideline and the above-mentioned problems are summarized. Aiming to stimulate these discussions, the operative software will be put on the Society's homepage for trial

  7. Co-firing Bosnian coals with woody biomass: Experimental studies on a laboratory-scale furnace and 110 MWe power unit

    Directory of Open Access Journals (Sweden)

    Smajevic Izet


    Full Text Available This paper presents the findings of research into cofiring two Bosnian cola types, brown coal and lignite, with woody biomass, in this case spruce sawdust. The aim of the research was to find the optimal blend of coal and sawdust that may be substituted for 100% coal in large coal-fired power stations in Bosnia and Herzegovina. Two groups of experimental tests were performed in this study: laboratory testing of co-firing and trial runs on a large-scale plant based on the laboratory research results. A laboratory experiment was carried out in an electrically heated and entrained pulverized-fuel flow furnace. Coal-sawdust blends of 93:7% by weight and 80:20% by weight were tested. Co-firing trials were conducted over a range of the following process variables: process temperature, excess air ratio and air distribution. Neither of the two coal-sawdust blends used produced any significant ash-related problems provided the blend volume was 7% by weight sawdust and the process temperature did not exceed 1250ºC. It was observed that in addition to the nitrogen content in the co-fired blend, the volatile content and particle size distribution of the mixture also influenced the level of NOx emissions. The brown coal-sawdust blend generated a further reduction of SO2 due to the higher sulphur capture rate than for coal alone. Based on and following the laboratory research findings, a trial run was carried out in a large-scale utility - the Kakanj power station, Unit 5 (110 MWe, using two mixtures; one in which 5%/wt and one in which 7%/wt of brown coal was replaced with sawdust. Compared to a reference firing process with 100% coal, these co-firing trials produced a more intensive redistribution of the alkaline components in the slag in the melting chamber, with a consequential beneficial effect on the deposition of ash on the superheater surfaces of the boiler. The outcome of the tests confirms the feasibility of using 7%wt of sawdust in combination

  8. The Interventional Arm of the Flexibility In Duty-Hour Requirements for Surgical Trainees Trial: First-Year Data Show Superior Quality In-Training Initiative Outcomes. (United States)

    Mirmehdi, Issa; O'Neal, Cindy-Marie; Moon, Davis; MacNew, Heather; Senkowski, Christopher

    With the implementation of strict 80-hour work week in general surgery training, serious questions have been raised concerning the quality of surgical education and the ability of newly trained general surgeons to independently operate. Programs that were randomized to the interventional arm of the Flexibility In duty-hour Requirements for Surgical Trainees (FIRST) Trial were able to decrease transitions and allow for better continuity by virtue of less constraints on duty-hour rules. Using National Surgical Quality Improvement Program Quality In-Training Initiative data along with duty-hour violations compared with old rules, it was hypothesized that quality of care would be improved and outcomes would be equivalent or better than the traditional duty-hour rules. It was also hypothesized that resident perception of compliance with duty hour would not change with implementation of new regulations based on FIRST trial. Flexible work hours were implemented on July 1, 2014. National Surgical Quality Improvement Program Quality In-Training Initiative information was reviewed from July 2014 to January 2015. Patient risk factors and outcomes were compared between institutional resident cases and the national cohort for comparison. Residents' duty-hour logs and violations during this period were compared to the 6-month period before the implementation of the FIRST trial. The annual Accreditation Council for Graduate Medical Education resident survey was used to assess the residents' perception of compliance with duty hours. With respect to the postoperative complications, the only statistically significant measures were higher prevalence of pneumonia (3.4% vs. 1.5%, p flexible duty hours. All other measures of postoperative surgical complications showed no difference. The total number of duty-hour violations decreased from 54 to 16. Had the institution not been part of the interventional arm of the FIRST trial, this number would have increased to 238. The residents

  9. Exploration of task performance tests in a physics laboratory (United States)

    Liu, Dan; El Turkey, Houssein


    In this article, we investigate the implementation of task performance tests in an undergraduate physics laboratory. Two performance tests were carried out over two semesters using the task of building a DC circuit. The first implementation in Spring 2014 had certain concerns such as the privacy of students’ testing and their ‘trial and error’ attempts. These concerns were addressed in Fall 2015 through implementing a second performance test. The second implementation was administered differently but the content of the two tests was the same. We discuss the validity of both implementations and present the correlation (or lack of) between the time that students needed to complete the tests and their grades from a paper-based laboratory assessment method.

  10. Blinding in randomized control trials: the enigma unraveled.

    Directory of Open Access Journals (Sweden)

    Vartika Saxena


    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.

  11. First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease.

    Directory of Open Access Journals (Sweden)

    Juan C Ramírez

    Full Text Available Real-Time PCR (qPCR testing is recommended as both a diagnostic and outcome measurement of etiological treatment in clinical practice and clinical trials of Chagas disease (CD, but no external quality assurance (EQA program provides performance assessment of the assays in use. We implemented an EQA system to evaluate the performance of molecular biology laboratories involved in qPCR based follow-up in clinical trials of CD. An EQA program was devised for three clinical trials of CD: the E1224 (NCT01489228, a pro-drug of ravuconazole; the Sampling Study (NCT01678599, that used benznidazole, both conducted in Bolivia; and the CHAGASAZOL (NCT01162967, that tested posaconazole, conducted in Spain. Four proficiency testing panels containing negative controls and seronegative blood samples spiked with 1, 10 and 100 parasite equivalents (par. eq./mL of four Trypanosoma cruzi stocks, were sent from the Core Lab in Argentina to the participating laboratories located in Bolivia and Spain. Panels were analyzed simultaneously, blinded to sample allocation, at 4-month intervals. In addition, 302 random blood samples from both trials carried out in Bolivia were sent to Core Lab for retesting analysis. The analysis of proficiency testing panels gave 100% of accordance (within laboratory agreement and concordance (between laboratory agreement for all T. cruzi stocks at 100 par. eq./mL; whereas their values ranged from 71 to 100% and from 62 to 100% at 1 and 10 par. eq./mL, respectively, depending on the T. cruzi stock. The results obtained after twelve months of preparation confirmed the stability of blood samples in guanidine-EDTA buffer. No significant differences were found between qPCR results from Bolivian laboratory and Core Lab for retested clinical samples. This EQA program for qPCR analysis of CD patient samples may significantly contribute to ensuring the quality of laboratory data generated in clinical trials and molecular diagnostics laboratories of

  12. [Qilin Pills for idiopathic oligoasthenospermia: A multi-centered randomized double-blind controlled clinical trial]. (United States)

    Mao, Jia-Ming; Jiang, Hui; Wang, Chuan-Hang; Ning, Ke-Qin; Liu, Ji-Hong; Yang, Shu-Wen; Li, Hai-Song; Zhou, Shao-Hu; Zhang, Zhi-Chao; Xu, Ji-Xiu; Huang, Yong-Han


    To evaluate the clinical efficacy and safety of Qilin Pills in the treatment of oligoasthenospermia in infertile men. This multi-centered randomized double-blind controlled clinical trial included 216 infertile males with oligoasthenospermia, 108 in the trial group and the other 108 in the control, the former treated with Qilin Pills at the dose of 6 g tid while the latter with Wuziyanzong Pills at 6 g bid, both for 12 weeks. We examined the total sperm count, sperm motility and the count of progressively motile sperm of the patients before and at 4, 8 and 12 weeks after medication and evaluated the safety of the drug based on the adverse events and the laboratory results of blood and urine routine examinations and liver and kidney function tests. Compared with the baseline, the patients in the trial group showed a significant time-dependent improvement after 4, 8 and 12 weeks of medication in sperm motility (21.75% vs 27.54%, 29.04% and 32.95%, P Pills can evidently improve the semen quality of oligoasthenospermia patients with no obvious adverse events.

  13. Quality control of the translation of the laboratory research into clinical practice

    International Nuclear Information System (INIS)

    Denekamp, J.


    This paper discusses the biological basis of new treatment strategies that are being introduced into the clinic in the form of controlled clinical trials. There is an increasing awareness of the need for quality assurance in the design, execution and analysis of these trials. However there is little awareness of the need to critically assess the biological basis of the trial design, to ensure that no other biological principles have been contravened in the attempt to optimise just one of the many parameters that determine the differential in sensitivity between tumours and normal tissues. Some examples are given of the changes that have recently occurred in the laboratory interpretation of both the mechanism of action and the therapeutic gain of several novel approaches. If these are not considered, the carefully controlled clinical trials may be wasted, because of being based on an incomplete consideration of all the interconnected biological factors. (author)

  14. Laboratory generation of gravitational waves

    International Nuclear Information System (INIS)

    Pinto, I.M.; Rotoli, G.


    The authors have performed calculations on the basic type of gravitational wave electromagnetic laboratory generators. Their results show that laboratory generations of gravitational wave is at limit of state-of-the-art of present-day giant electromagnetic field generation

  15. Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial. (United States)

    Arabi, Yaseen M; Alothman, Adel; Balkhy, Hanan H; Al-Dawood, Abdulaziz; AlJohani, Sameera; Al Harbi, Shmeylan; Kojan, Suleiman; Al Jeraisy, Majed; Deeb, Ahmad M; Assiri, Abdullah M; Al-Hameed, Fahad; AlSaedi, Asim; Mandourah, Yasser; Almekhlafi, Ghaleb A; Sherbeeni, Nisreen Murad; Elzein, Fatehi Elnour; Memon, Javed; Taha, Yusri; Almotairi, Abdullah; Maghrabi, Khalid A; Qushmaq, Ismael; Al Bshabshe, Ali; Kharaba, Ayman; Shalhoub, Sarah; Jose, Jesna; Fowler, Robert A; Hayden, Frederick G; Hussein, Mohamed A


    It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018., ID: NCT02845843 . Registered on 27 July 2016.

  16. Use of proficiency samples to assess diagnostic laboratories in France performing a Trichinella digestion assay. (United States)

    Vallée, Isabelle; Macé, Pauline; Forbes, Lorry; Scandrett, Brad; Durand, Benoit; Gajadhar, Alvin; Boireau, Pascal


    Routine diagnosis of animal trichinellosis for food safety and trade relies on a method of artificial digestion to free Trichinella muscle larvae from meat for subsequent identification by microscopy. As part of a quality control system, the French National Reference Laboratory (NRL) initiated ring trials to determine the sensitivity of the test performed in the 72 routine diagnostic laboratories in France. A method was devised to obtain calibrated meat samples containing known numbers of capsules with Trichinella spiralis muscle larvae. This method was based on an incomplete artificial digestion of Trichinella-infected mice carcasses to allow the collection of intact Trichinella capsules. Capsules were placed into a meatball of 100 +/- 2 g of pork and horsemeat to produce proficiency samples. Three categories of samples were prepared: small (3 to 5 capsules), medium (7 to 10), and large (12 to 15). The sensitivity was expressed as the percentage of muscle larvae recovered from each proficiency sample. Reproducibility was tested with ring trials organized between two NRLs (France and Canada), and a reference sensitivity of 84.9% was established. National ring trials were then organized in France, with the 72 routine diagnostic laboratories each receiving four proficiency samples per session. After five sessions, an improvement in the digest test sensitivity was observed. Results at the fifth session indicated sensitivities of 78.60% +/- 23.70%, 81.19% +/- 19.59%, and 80.52% +/- 14.71% muscle larvae for small, medium, and large samples, respectively. This study supports the use of proficiency samples to accurately evaluate the performance of routine diagnostic laboratories that conduct digestion tests for animal trichinellosis diagnosis.

  17. Reward-prospect interacts with trial-by-trial preparation for potential distraction. (United States)

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


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

  18. Time Trials--An AP Physics Challenge Lab (United States)

    Jones, David


    I have come to the conclusion that for high school physics classroom and laboratory experiences, simpler is better! In this paper I describe a very simple and effective lab experience that my AP students have thoroughly enjoyed year after year. I call this lab exercise "Time Trials." The experiment is simple in design and it is a lot of fun for…

  19. Impact of botanical extracts derived from Melia azedarach and Azadirachta indica on populations of Plutella xylostella and its natural enemies: A field test of laboratory findings

    NARCIS (Netherlands)

    Charleston, D.S.; Kfir, R.; Dicke, M.; Vet, L.E.M.


    Differences between results from ecological laboratory studies and what actually happens in the field can be large. Therefore, field experiments are essential to validate laboratory findings. In previous laboratory trials we investigated the impact of aqueous leaf extracts from the syringa tree,

  20. Impact of botanical extracts derived from Melia azedarach and Azadirachta indica on populations of Plutella xylostella and its natural enemies: a field test of laboratory findings

    NARCIS (Netherlands)

    Charleston, D.S.; Kfir, R.; Dicke, M.; Vet, L.E.M.


    Differences between results from ecological laboratory studies and what actually happens in the field can be large. Therefore, field experiments are essential to validate laboratory findings. In previous laboratory trials we investigated the impact of aqueous leaf extracts from the syringa tree,

  1. [View of a Laboratory Physician on the Present and Future of Clinical Laboratories]. (United States)

    Matsuo, Shuji


    It is meaningful to discuss the "present and future of laboratories" for the development of laboratories and education of medical technologists. Laboratory staff must be able to perform urgent high-quality tests and take part in so-called team-based medicine and should be proud of devising systems that efficiently provide laboratory data for all medical staff. On the other hand, there may be staff with a poor sense of professionalism who work no more than is expected and too readily ask firms and commercial laboratories to solve problems. Overwork caused by providing team-based medicine and a decrease in numbers of clinical chemists are concerns. The following are hoped for in the future. Firstly, laboratory staff will become conscious of their own high-level abilities and expand their areas of work, for example, bioscience, proteomics, and reproductive medicine. Secondly, a consultation system for medical staff and patients will be established. Thirdly, clinical research will be advanced, such as investigating unknown pathophysiologies using laboratory data and samples, and developing new methods of measurement. Lastly, it is of overriding importance that staff of laboratory and educational facilities will cooperate with each other to train the next generation. In conclusion, each laboratory should be appreciated, attractive, positive regarding its contribution to society, and show individuality.

  2. Direct fault dating trials at the Aespoe Hard Rock Laboratory

    International Nuclear Information System (INIS)

    Maddock, R.H.; Hailwood, E.A.


    Over seventy rock samples were collected from fault and fracture zones in the Aespoe Hard Rock Laboratory tunnel for a study of direct fault dating techniques. Following microstructural and mineralogical analysis, isotopic, palaeomagnetic and electron spin resonance (ESR) methods were employed in an attempt to determine the age of the most recent movements on the sampled faults. The larger fracture zones contain faultrock assemblages and microstructures which are consistent with a prolonged and polyphase movement history, although the cumulative displacements involved formation of fault gouge cemented by authigenic 'illite'. Dating studies were targeted particularly at the gouge but also at older fault rock and vein phases. ESR dating of quartz graines, separated from gouge from fracture zones NE-4 and NE-3, strongly indicates that the ESR signals have not been reset by fault movements for a minimum time period of several hundred thousand to one million years. Palaeomagnetic dating of gouge from fracture zone NE-4 shows that a stable component of magnetisation overlaps both Precambrian and Permo-Triassic parts of the apparent polar wander curve. The younger age of magnetisation is preferred on geological grounds and by comparison with the isotopic dating results. The magnetisation may correspond to a diagenetic event following fault movement. Palaeomagnetic ages determined on countryrock and epidote vein samples are largely consistent with independent age constraints. K-Ar dating of clay fractions (<2 to <0.05μm) separated from gouge from four faults, including fracture zones NE-4 and NE-3, gave model ages in the range 706-301Ma. Accounting for the effects of contamination by potassium-bearing porphyroclasts, it is likely that authigenic 'illite' was formed at least 250 million years ago, after the most recent significant fault movements. 100 refs., 60 figs., 26 tabs

  3. Juvenile female rats, but not male rats, show renewal, reinstatement, and spontaneous recovery following extinction of conditioned fear. (United States)

    Park, Chun Hui J; Ganella, Despina E; Kim, Jee Hyun


    Anxiety disorders emerge early, and girls are significantly more likely to develop anxiety compared to boys. However, sex differences in fear during development are poorly understood. Therefore, we investigated juvenile male and female rats in the relapse behaviors following extinction of conditioned fear. In all experiments, 18-d-old rats first received three white-noise-footshock pairings on day 1. On day 2, extinction involved 60 white-noise alone trials. In experiment 1, we examined renewal by testing the rats in either the same or different context as extinction on day 3. Male rats did not show renewal, however, female rats showed renewal. Experiment 2 investigated reinstatement by giving rats either a mild reminder footshock or context exposure on day 3. When tested the next day, male rats did not show reinstatement, whereas female rats showed reinstatement. Experiment 3 investigated spontaneous recovery by testing the rats either 1 or 5 d following extinction. Male rats did not show any spontaneous recovery whereas female rats did. Taken together, fear regulation appear to be different in males versus females from early in development, which may explain why girls are more prone to suffer from anxiety disorders compared to boys. © 2017 Park et al.; Published by Cold Spring Harbor Laboratory Press.

  4. Effect of individually tailored biopsychosocial workplace interventions on chronic musculoskeletal pain, stress and work ability among laboratory technicians: randomized controlled trial protocol. (United States)

    Jay, Kenneth; Brandt, Mikkel; Sundstrup, Emil; Schraefel, Mc; Jakobsen, Markus D; Sjøgaard, Gisela; Andersen, Lars L


    Among laboratory technicians, the prevalence of neck and shoulder pain is widespread possibly due to typical daily work tasks such as pipetting, preparing vial samples for analysis, and data processing on a computer including mouse work - all tasks that require precision in motor control and may result in extended periods of time spent in static positions.In populations characterized by intense chronic musculoskeletal pain and diagnosed conditions in conjunction with psycho-physiological symptoms such as stress-related pain and soreness and other disabling conditions, multifactorial approaches applying a combination of individually tailored physical and cognitive strategies targeting the areas most needed, may be an effective solution to the physical and mental health challenges.The aim of this study is therefore to investigate the effect of an individually tailored biopsychosocial intervention strategy on musculoskeletal pain, stress and work disability in lab technicians with a history of musculoskeletal pain at a single worksite in Denmark. In this single-blind two-armed parallel-group randomized controlled trial with allocation concealment, participants receive either an individualized multifactorial intervention or "usual care" for 10 weeks at the worksite. 1) female laboratory technician (18-67 years of age) and 2) Pain intensity ≥ 3 (0-10 Visual Analogue Scale) lasting ≥3 months with a frequency of ≥ 3 days per week in one or more of the following regions: i) upper back i) low back iii) neck, iv) shoulder, v) elbow and/or vi) hand. 1) life-threatening disease and 2) pregnancy. Stress, as measured by Cohen´s perceived stress questionnaire is not an inclusion criteria, thus participants can participate regardless of their stress level.We will implement an individualized intervention addressing biopsychosocial elements of musculoskeletal pain with the following components; i) increasing physical capacity through strength- and motor control

  5. Oak Ridge National Laboratory Institutional Plan FY 1984-FY 1989

    International Nuclear Information System (INIS)


    In this plan, Oak Ridge National Laboratory (ORNL) continues to be committed to scientific and technological research that is based on technical excellence and innovation and that provides a foundation for and a stimulus to broader and more sustained economic growth. DOE is being asked to assist in establishing a new program for Laboratory cooperation with industry, beginning with an initial focus on materials science. The current Institutional Plan thus projects growth in the materials science area as well as in other basic physical science areas and suggests a new initiative designed to extend the various technology transfer activities and to make them more effective by using ORNL as the trial Laboratory for some of these different approaches. This Institutional Plan projects a stable future for ORNL, with only modest amounts of growth in selected areas of research for the FY 1984-FY 1989 planning cycle. Summaries of the overall picture of the proposed budget and personnel levels for the current planning cycle are included. Scientific programs, laboratory resource development, and private sector interactions are discussed

  6. Managing laboratory automation


    Saboe, Thomas J.


    This paper discusses the process of managing automated systems through their life cycles within the quality-control (QC) laboratory environment. The focus is on the process of directing and managing the evolving automation of a laboratory; system examples are given. The author shows how both task and data systems have evolved, and how they interrelate. A BIG picture, or continuum view, is presented and some of the reasons for success or failure of the various examples cited are explored. Fina...

  7. Chronic cannabis users show altered neurophysiological functioning on Stroop task conflict resolution. (United States)

    Battisti, Robert A; Roodenrys, Steven; Johnstone, Stuart J; Pesa, Nicole; Hermens, Daniel F; Solowij, Nadia


    Chronic cannabis use has been related to deficits in cognition (particularly memory) and the normal functioning of brain structures sensitive to cannabinoids. There is increasing evidence that conflict monitoring and resolution processes (i.e. the ability to detect and respond to change) may be affected. This study examined the ability to inhibit an automatic reading response in order to activate a more difficult naming response (i.e. conflict resolution) in a variant of the discrete trial Stroop colour-naming task. Event-related brain potentials to neutral, congruent and incongruent trials were compared between 21 cannabis users (mean 16.4 years of near daily use) in the unintoxicated state and 19 non-using controls. Cannabis users showed increased errors on colour-incongruent trials (e.g. "RED" printed in blue ink) but no performance differences from controls on colour congruent (e.g. "RED" printed in red ink) or neutral trials (e.g. "*****" printed in green ink). Poorer incongruent trial performance was predicted by an earlier age of onset of regular cannabis use. Users showed altered expression of a late sustained potential related to conflict resolution, evident by opposite patterns of activity between trial types at midline and central sites, and altered relationships between neurophysiological and behavioural outcome measures not evident in the control group. These findings indicate that chronic use of cannabis may impair the brain's ability to respond optimally in the presence of events that require conflict resolution and hold implications for the ability to refrain from substance misuse and/or maintain substance abstention behaviours.

  8. Prioritizing factors affecting the hospital employees' productivity from the hospital managers' viewpoint using integrated decision-making trial and evaluation laboratory and analytic network process

    Directory of Open Access Journals (Sweden)

    Ardalan Feili


    Full Text Available Objectives: This study aimed to identify and prioritize factors affecting the hospital employees' productivity from the viewpoint of hospital managers working in the teaching hospitals affiliated to Iran, Shiraz University of Medical Sciences, in 2017. Materials and Methods: This was an applied, cross-sectional, and descriptive-analytical study conducted in 2017 in all teaching hospitals affiliated to Iran, Shiraz University of Medical Sciences. After identifying factors affecting hospital employees' productivity using the results of previous studies, all hospital managers (56 managers were selected as the study population using census method to prioritize the factors. The decision-making trial and evaluation laboratory (DEMATEL and analytic network process (ANP techniques were used for analyzing the collected data through Excel 2010 and Super Decision 2.8. Results: Fifteen factors affecting employees' productivity were determined using the results of previous studies which were classified into four clusters. The results of DEMATEL technique showed that “employees' attitude toward the organization” was the most affecting factor (r = 11.928 and also the most affected factor (c = 12.120, as well as the most important factor affecting the employees' productivity (r + c = 24.048. In addition, the results of ANP showed that the cluster of “leadership and management styles” (relative weight [RW] = 0.274 and its factors, especially “involving employees in the decision-making processes” (L1 (RW = 0.102 and “delegation of authority to the employees” (L2 (RW = 0.100 were the most important factors affecting the employees' productivity. Conclusion: According to the results, adopting an appropriate leadership style and providing participatory management, involving the employees in the hospital decision-making processes, etc., had significant effects on the increases in the employees' motivation and productivity.

  9. Human Laboratory Settings for Assessing Drug Craving; Implications for the Evaluation of Treatment Efficacy

    Directory of Open Access Journals (Sweden)

    Zahra Alam Mehrjerdi


    Full Text Available Research on assessing craving in laboratory settings often involves inducing and then measuring craving in subjects. Cue-induced craving is studied in laboratory settings using the cue reactivity paradigm, in which drug-related photos, videos, evocative scripts, olfactory cues, and paraphernalia may induce craving. Cue-induced craving evoked by drug-related stimuli could be associated with relapse and recurrence of drug addiction. In this article, the authors review different methods of assessing craving in laboratory settings and explain how human laboratory settings can bridge the gap between randomized clinical trials (RCTs and animal models on pharmacological treatments for drug dependence. The brief reviewed literature provides strong evidence that laboratory-based studies of craving may improve our understanding of how subjective reports of drug craving are related to objective measures of drug abuse and laboratory settings provide an opportunity to measure the degree to which they co-vary during pharmacological interventions. This issue has important implications inclinical studies.

  10. Human Laboratory Settings for Assessing Drug Craving Implications for the Evaluation of Treatment Efficacy

    Directory of Open Access Journals (Sweden)

    Zahra Alam Mehrjerdi


    Full Text Available Research on assessing craving in laboratory settings often involves inducing and then measuring craving in subjects. Cue-induced craving is studied in laboratory settings using the cue reactivity paradigm, in which drug-related photos, videos, evocative scripts, olfactory cues, and paraphernalia may induce craving. Cue-induced craving evoked by drug-related stimuli could be associated with relapse and recurrence of drug addiction. In this article, the authors review different methods of assessing craving in laboratory settings and explain how human laboratory settings can bridge the gap between randomized clinical trials (RCTs and animal models on pharmacological treatments for drug dependence. The brief reviewed literature provides strong evidence that laboratory-based studies of craving may improve our understanding of how subjective reports of drug craving are related to objective measures of drug abuse and laboratory settings provide an opportunity to measure the degree to which they co-vary during pharmacological interventions. This issue has important implications inclinical studies.

  11. Quantifying and visualizing site performance in clinical trials

    Directory of Open Access Journals (Sweden)

    Eric Yang


    Conclusions: The use of operational data from Covance Central Laboratories provides a unique perspective into the performance of clinical sites with respect to many important metrics such as patient enrollment and retention. These metrics can, in turn, be used to guide operational planning and site selection for new clinical trials, thereby accelerating recruitment, improving quality, and reducing cost.

  12. Results of the eurofoods trial on between-laboratory variation in the analysis of macronutrients in foods

    NARCIS (Netherlands)

    Hollman, Peter C. H.; Katan, M.B.


    In order to determine the influence of laboratory procedures on nutrient values in different food tables and data banks, an interlaboratory study was set up. Nineteen laboratories participated, and received well-homogenized samples of egg powder, full-fat milk powder, whole rye and wheat meal,

  13. Results of the Eurofood trials on between-laboratory variation in the analysis of macronutrient in foods.

    NARCIS (Netherlands)

    Hollman, P.C.H.; Katan, M.B.


    In order to determine the influence of laboratory procedures on nutrient values in different food tables and data banks, an interlaboratory study was set up. Nineteen laboratories participated, and received well-homogenized samples of egg powder, full-fat milk powder, whole rye and wheat meal,

  14. Tests for oil/dispersant toxicity: In situ laboratory assays

    International Nuclear Information System (INIS)

    Wright, D.A.; Coelho, G.M.; Aurand, D.V.


    As part of its readiness program in oil spill response, the Marine Pollution Control Unit (MPCU), Department of Transport, U.K. conducts annual field trials in the North Sea, approximately 30 nautical miles from the southeast coast of England. The trials take the form of controlled releases of crude oil or Medium Fuel/Gas Oil mix (MFO), with and without the application of Corexit 9527 dispersant. In 1994 and 1995 the authors conducted a series of in situ toxicity bioassays in association with these spills with included 48h LC50 tests for turbot (Scophthalmus maximus) and oyster (Crassostrea gigas) larvae, a 48 h oyster (C. gigas) embryonic development test and two full life-cycle assays using the copepods Acartia tonsa and Tisbe battagliai. Tests were also conducted in the Chesapeake Bay laboratory using estuarine species including the copepod Eurytemora affinis and the inland silverside Menidia beryllina. Here, the authors report on the results of these assays, together with 1996 in situ toxicity data resulting from Norwegian field trials in the northern North Sea

  15. [Safety in the Microbiology laboratory]. (United States)

    Rojo-Molinero, Estrella; Alados, Juan Carlos; de la Pedrosa, Elia Gómez G; Leiva, José; Pérez, José L


    The normal activity in the laboratory of microbiology poses different risks - mainly biological - that can affect the health of their workers, visitors and the community. Routine health examinations (surveillance and prevention), individual awareness of self-protection, hazard identification and risk assessment of laboratory procedures, the adoption of appropriate containment measures, and the use of conscientious microbiological techniques allow laboratory to be a safe place, as records of laboratory-acquired infections and accidents show. Training and information are the cornerstones for designing a comprehensive safety plan for the laboratory. In this article, the basic concepts and the theoretical background on laboratory safety are reviewed, including the main legal regulations. Moreover, practical guidelines are presented for each laboratory to design its own safety plan according its own particular characteristics. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  16. Clinical trials of homoeopathy. (United States)

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


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

  17. Korogwe Research Laboratory

    DEFF Research Database (Denmark)

    Knudsen, Jakob


    . It is a large vaccine trial programme simultaneously conducted in several countries in Africa funded by the Bill and Melinda Gates Foundation. The laboratory is an extension to a district hospital placed quite isolated and rural in the north-eastern part of Tanzania. It’s close to the equator and the climate...... and ceiling have been separated leaving a large space for natural ventilation creating a general chimney effect. To provide independent backup water supply all rainwater falling on the roof is collected and directed through a sand filter into a 100m3 subterranean water tank. All constructions, details...... and materials have been carefully selected to last a long time even in a future situation with limited maintenance. Except from the high-end lab equipment only local available materials have been used. All major spaces are reached from colonnades surrounding an inner calm and cool garden space equipped...

  18. Laboratory simulations show diabatic heating drives cumulus-cloud evolution and entrainment (United States)

    Narasimha, Roddam; Diwan, Sourabh Suhas; Duvvuri, Subrahmanyam; Sreenivas, K. R.; Bhat, G. S.


    Clouds are the largest source of uncertainty in climate science, and remain a weak link in modeling tropical circulation. A major challenge is to establish connections between particulate microphysics and macroscale turbulent dynamics in cumulus clouds. Here we address the issue from the latter standpoint. First we show how to create bench-scale flows that reproduce a variety of cumulus-cloud forms (including two genera and three species), and track complete cloud life cycles—e.g., from a “cauliflower” congestus to a dissipating fractus. The flow model used is a transient plume with volumetric diabatic heating scaled dynamically to simulate latent-heat release from phase changes in clouds. Laser-based diagnostics of steady plumes reveal Riehl–Malkus type protected cores. They also show that, unlike the constancy implied by early self-similar plume models, the diabatic heating raises the Taylor entrainment coefficient just above cloud base, depressing it at higher levels. This behavior is consistent with cloud-dilution rates found in recent numerical simulations of steady deep convection, and with aircraft-based observations of homogeneous mixing in clouds. In-cloud diabatic heating thus emerges as the key driver in cloud development, and could well provide a major link between microphysics and cloud-scale dynamics. PMID:21918112

  19. Improved Endpoints for Cancer Immunotherapy Trials (United States)

    Eggermont, Alexander M. M.; Janetzki, Sylvia; Hodi, F. Stephen; Ibrahim, Ramy; Anderson, Aparna; Humphrey, Rachel; Blumenstein, Brent; Wolchok, Jedd


    Unlike chemotherapy, which acts directly on the tumor, cancer immunotherapies exert their effects on the immune system and demonstrate new kinetics that involve building a cellular immune response, followed by changes in tumor burden or patient survival. Thus, adequate design and evaluation of some immunotherapy clinical trials require a new development paradigm that includes reconsideration of established endpoints. Between 2004 and 2009, several initiatives facilitated by the Cancer Immunotherapy Consortium of the Cancer Research Institute and partner organizations systematically evaluated an immunotherapy-focused clinical development paradigm and created the principles for redefining trial endpoints. On this basis, a body of clinical and laboratory data was generated that supports three novel endpoint recommendations. First, cellular immune response assays generate highly variable results. Assay harmonization in multicenter trials may minimize variability and help to establish cellular immune response as a reproducible biomarker, thus allowing investigation of its relationship with clinical outcomes. Second, immunotherapy may induce novel patterns of antitumor response not captured by Response Evaluation Criteria in Solid Tumors or World Health Organization criteria. New immune-related response criteria were defined to more comprehensively capture all response patterns. Third, delayed separation of Kaplan–Meier curves in randomized immunotherapy trials can affect results. Altered statistical models describing hazard ratios as a function of time and recognizing differences before and after separation of curves may allow improved planning of phase III trials. These recommendations may improve our tools for cancer immunotherapy trials and may offer a more realistic and useful model for clinical investigation. PMID:20826737

  20. Practical experience with graphical user interfaces and object-oriented design in the clinical laboratory. (United States)

    Wells, I G; Cartwright, R Y; Farnan, L P


    The computing strategy in our laboratories evolved from research in Artificial Intelligence, and is based on powerful software tools running on high performance desktop computers with a graphical user interface. This allows most tasks to be regarded as design problems rather than implementation projects, and both rapid prototyping and an object-oriented approach to be employed during the in-house development and enhancement of the laboratory information systems. The practical application of this strategy is discussed, with particular reference to the system designer, the laboratory user and the laboratory customer. Routine operation covers five departments, and the systems are stable, flexible and well accepted by the users. Client-server computing, currently undergoing final trials, is seen as the key to further development, and this approach to Pathology computing has considerable potential for the future.

  1. Building Capacity for HIV/AIDS Prevention Trials Research and ...

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

    A relatively small number of African sites have the clinical and laboratory capacity to design, manage and carry out HIV/AIDS prevention trials. This project is based on the premise that many of the required skills are already present at additional locations, but need further development. The grant will facilitate interaction ...

  2. Physical barriers formed from gelling liquids: 1. numerical design of laboratory and field experiments

    International Nuclear Information System (INIS)

    Finsterle, S.; Moridis, G.J.; Pruess, K.; Persoff, P.


    The emplacement of liquids under controlled viscosity conditions is investigated by means of numerical simulations. Design calculations are performed for a laboratory experiment on a decimeter scale, and a field experiment on a meter scale. The purpose of the laboratory experiment is to study the behavior of multiple gout plumes when injected in a porous medium. The calculations for the field trial aim at designing a grout injection test from a vertical well in order to create a grout plume of a significant extent in the subsurface

  3. Busted Butte report on laboratory radionuclide migration experiments in non-welded tuff under unsaturated conditions

    Energy Technology Data Exchange (ETDEWEB)

    Vandergraaf, T.T.; Drew, D.J.; Ticknor, K.V


    Three blocks of non-welded tuff, one nominally one cubic foot (trial block) and the other two, nominally one cubic metre (1 m{sup 3}), were excavated from the Busted Butte Test Facility on the Nevada Test Site and transported to the Atomic Energy of Canada Limited Whiteshell Laboratories in Pinawa, Manitoba. The trial block and one of the 1-m{sup 3} blocks were used for unsaturated flow experiments. The remaining 1-m{sup 3} block is being used for saturated flow experiments and will be reported on separately. After a vertical flow of synthetic transport solution was set up under unsaturated conditions, a suite of conservative and chemically reactive radionuclide tracers was injected at volumetric flow rates of 20 mL/hr in the trial block, and 10 mL/hr in the 1-m{sup 3} block. The duration of the migration experiment in the trial block was 87 days, while the migration experiment in the 1-m{sup 3} block was continuing after 600 days. Results obtained from the migration experiment in the trial block showed that transport of {sup 95m+99}Tc, injected as the pertechnetate (an)ion, was slightly faster than that of the transport solution, using tritiated water ({sup 3}H{sub 2}O) as a flow indicator. Retardation of {sup 237}Np was consistent with that predicted from results obtained in supporting static batch sorption studies. Post-migration analysis of the flow field in the trial block showed that the front of the {sup 22}Na had migrated about half the distance through the block, and that {sup 60}Co and {sup 137}Cs had been retained near the inlet. This observation agrees qualitatively with that predicted from the results from static batch sorption studies. In the larger scale experiment, the transport behavior of Tc is very similar to that of the transport solution at this point in time. None of the other radionuclide tracers have been detected in water collected from this block. This observation is consistent with the observations for the smaller block. (author)

  4. Standardization of glycohemoglobin results and reference values in whole blood studied in 103 laboratories using 20 methods. (United States)

    Weykamp, C W; Penders, T J; Miedema, K; Muskiet, F A; van der Slik, W


    We investigated the effect of calibration with lyophilized calibrators on whole-blood glycohemoglobin (glyHb) results. One hundred three laboratories, using 20 different methods, determined glyHb in two lyophilized calibrators and two whole-blood samples. For whole-blood samples with low (5%) and high (9%) glyHb percentages, respectively, calibration decreased overall interlaboratory variation (CV) from 16% to 9% and from 11% to 6% and decreased intermethod variation from 14% to 6% and from 12% to 5%. Forty-seven laboratories, using 14 different methods, determined mean glyHb percentages in self-selected groups of 10 nondiabetic volunteers each. With calibration their overall mean (2SD) was 5.0% (0.5%), very close to the 5.0% (0.3%) derived from the reference method used in the Diabetes Control and Complications Trial. In both experiments the Abbott IMx and Vision showed deviating results. We conclude that, irrespective of the analytical method used, calibration enables standardization of glyHb results, reference values, and interpretation criteria.

  5. Managing laboratory automation. (United States)

    Saboe, T J


    This paper discusses the process of managing automated systems through their life cycles within the quality-control (QC) laboratory environment. The focus is on the process of directing and managing the evolving automation of a laboratory; system examples are given. The author shows how both task and data systems have evolved, and how they interrelate. A BIG picture, or continuum view, is presented and some of the reasons for success or failure of the various examples cited are explored. Finally, some comments on future automation need are discussed.

  6. Implementation of a configurable laboratory information management system for use in cellular process development and manufacturing. (United States)

    Russom, Diana; Ahmed, Amira; Gonzalez, Nancy; Alvarnas, Joseph; DiGiusto, David


    Regulatory requirements for the manufacturing of cell products for clinical investigation require a significant level of record-keeping, starting early in process development and continuing through to the execution and requisite follow-up of patients on clinical trials. Central to record-keeping is the management of documentation related to patients, raw materials, processes, assays and facilities. To support these requirements, we evaluated several laboratory information management systems (LIMS), including their cost, flexibility, regulatory compliance, ongoing programming requirements and ability to integrate with laboratory equipment. After selecting a system, we performed a pilot study to develop a user-configurable LIMS for our laboratory in support of our pre-clinical and clinical cell-production activities. We report here on the design and utilization of this system to manage accrual with a healthy blood-donor protocol, as well as manufacturing operations for the production of a master cell bank and several patient-specific stem cell products. The system was used successfully to manage blood donor eligibility, recruiting, appointments, billing and serology, and to provide annual accrual reports. Quality management reporting features of the system were used to capture, report and investigate process and equipment deviations that occurred during the production of a master cell bank and patient products. Overall the system has served to support the compliance requirements of process development and phase I/II clinical trial activities for our laboratory and can be easily modified to meet the needs of similar laboratories.

  7. National survey on intra-laboratory turnaround time for some most common routine and stat laboratory analyses in 479 laboratories in China. (United States)

    Fei, Yang; Zeng, Rong; Wang, Wei; He, Falin; Zhong, Kun; Wang, Zhiguo


    To investigate the state of the art of intra-laboratory turnaround time (intra-TAT), provide suggestions and find out whether laboratories accredited by International Organization for Standardization (ISO) 15189 or College of American Pathologists (CAP) will show better performance on intra-TAT than non-accredited ones. 479 Chinese clinical laboratories participating in the external quality assessment programs of chemistry, blood gas, and haematology tests organized by the National Centre for Clinical Laboratories in China were included in our study. General information and the median of intra-TAT of routine and stat tests in last one week were asked in the questionnaires. The response rate of clinical biochemistry, blood gas, and haematology testing were 36% (479/1307), 38% (228/598), and 36% (449/1250), respectively. More than 50% of laboratories indicated that they had set up intra-TAT median goals and almost 60% of laboratories declared they had monitored intra-TAT generally for every analyte they performed. Among all analytes we investigated, the intra-TAT of haematology analytes was shorter than biochemistry while the intra-TAT of blood gas analytes was the shortest. There were significant differences between median intra-TAT on different days of the week for routine tests. However, there were no significant differences in median intra-TAT reported by accredited laboratories and non-accredited laboratories. Many laboratories in China are aware of intra-TAT control and are making effort to reach the target. There is still space for improvement. Accredited laboratories have better status on intra-TAT monitoring and target setting than the non-accredited, but there are no significant differences in median intra-TAT reported by them.

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

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


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

  9. Online general pre-laboratory training course for facilitating first year chemical laboratory use

    Directory of Open Access Journals (Sweden)

    Maria Limniou


    Full Text Available In Chemistry, practical work is a highly demanding process in which students should be well-prepared before and alert during,laboratory sessions. Various general difficulties such as the limited laboratory time and the lack of connections between theoryand practicals often do not allow students to actively participate in the learning process. The aim of this investigation is to studyhow an online general pre-laboratory training course inspired by cognitive load theory influenced the teaching of first yearchemistry students engaged in laboratory work. Two different groups of chemistry students (experimental group (EG andcontrol group (CG from the University of Manchester participated in this investigation. The EG group participated in the onlinepre-laboratory course before entering the laboratory, while the CG group performed the experiments following the traditionalteaching procedure. The comparison of students’ responses to the same assessments of fundamental chemical and basiclaboratory knowledge showed that overall the performance of the EG group of students was higher than that of the CGstudents. Overall, the EG students valued the opportunity to have an online training course. By creating a flexible learningenvironment which included animations, simulations and self-assessments, the general laboratory difficulties were overcome.These interactive learning features gave students the opportunity to engage in independent study, by which restrictions of timeand place were overcome.

  10. Trial Courts in the Judicial Process. (United States)

    McKnight, R. Neal


    Describes a college course which examines the organizational and behavioral characteristics of trial courts in the American judicial process. A major course objective is to help students understand the trial court process as a political process by showing how trial court organizations are involved in the allocation of social values. (RM)

  11. Electronic audit and feedback intervention with action implementation toolbox to improve pain management in intensive care: protocol for a laboratory experiment and cluster randomised trial. (United States)

    Gude, Wouter T; Roos-Blom, Marie-José; van der Veer, Sabine N; de Jonge, Evert; Peek, Niels; Dongelmans, Dave A; de Keizer, Nicolette F


    Audit and feedback is often used as a strategy to improve quality of care, however, its effects are variable and often marginal. In order to learn how to design and deliver effective feedback, we need to understand their mechanisms of action. This theory-informed study will investigate how electronic audit and feedback affects improvement intentions (i.e. information-intention gap), and whether an action implementation toolbox with suggested actions and materials helps translating those intentions into action (i.e. intention-behaviour gap). The study will be executed in Dutch intensive care units (ICUs) and will be focused on pain management. We will conduct a laboratory experiment with individual ICU professionals to assess the impact of feedback on their intentions to improve practice. Next, we will conduct a cluster randomised controlled trial with ICUs allocated to feedback without or feedback with action implementation toolbox group. Participants will not be told explicitly what aspect of the intervention is randomised; they will only be aware that there are two variations of providing feedback. ICUs are eligible for participation if they submit indicator data to the Dutch National Intensive Care Evaluation (NICE) quality registry and agree to allocate a quality improvement team that spends 4 h per month on the intervention. All participating ICUs will receive access to an online quality dashboard that provides two functionalities: gaining insight into clinical performance on pain management indicators and developing action plans. ICUs with access to the toolbox can develop their action plans guided by a list of potential barriers in the care process, associated suggested actions, and supporting materials to facilitate implementation of the actions. The primary outcome measure for the laboratory experiment is the proportion of improvement intentions set by participants that are consistent with recommendations based on peer comparisons; for the randomised

  12. Laboratory hematology in the history of Clinical Chemistry and Laboratory Medicine. (United States)

    Hoffmann, Johannes J M L


    For the occasion of the 50th anniversary of the journal Clinical Chemistry and Laboratory Medicine (CCLM), an historic overview of papers that the journal has published in the field of laboratory hematology (LH) is presented. All past volumes of CCLM were screened for papers on LH and these were categorized. Bibliographic data of these papers were also analyzed. CCLM published in total 387 LH papers. The absolute number of LH papers published annually showed a significant increase over the years since 1985. Also the share of LH papers demonstrated a steady increase (overall mean 5%, but mean 8% over the past 4 years). The most frequent category was coagulation and fibrinolysis (23.5%). Authors from Germany contributed the most LH papers to the journal (22.7%), followed by the Netherlands and Italy (16.3 and 13.2%, respectively). Recent citation data indicated that other publications cited LH review papers much more frequently than other types of papers. The history of the journal reflects the emergence and development of laboratory hematology as a separate discipline of laboratory medicine.

  13. A comparison of liquid and solid culture for determining relapse and durable cure in phase III TB trials for new regimens. (United States)

    Phillips, Patrick P J; Mendel, Carl M; Nunn, Andrew J; McHugh, Timothy D; Crook, Angela M; Hunt, Robert; Bateson, Anna; Gillespie, Stephen H


    Tuberculosis kills more people than any other infectious disease, and new regimens are essential. The primary endpoint for confirmatory phase III trials for new regimens is a composite outcome that includes bacteriological treatment failure and relapse. Culture methodology is critical to the primary trial outcome. Patients in clinical trials can have positive cultures after treatment ends that may not necessarily indicate relapse, which was ascribed previously to laboratory cross-contamination or breakdown of old lesions. Löwenstein-Jensen (LJ) medium was the previous standard in clinical trials, but almost all current and future trials will use the Mycobacteria Growth Indicator Tube (MGIT) system due to its simplicity and consistency of use, which will affect phase III trial results. LJ was used for the definition of the primary endpoint in the REMoxTB trial, but every culture was also inoculated in parallel into the MGIT system. The data from this trial, therefore, provide a unique opportunity to investigate and compare the incidence of false 'isolated positives' in liquid and solid media and their potential impact on the primary efficacy results. All post-treatment positive cultures were reviewed in the REMoxTB clinical trial. Logistic regression models were used to model the incidence of isolated positive cultures on MGIT and LJ. A total of 12,209 sputum samples were available from 1652 patients; cultures were more often positive on MGIT than LJ. In 1322 patients with a favourable trial outcome, 126 (9.5%) had cultures that were positive in MGIT compared to 34 (2.6%) patients with positive cultures on LJ. Among patients with a favourable outcome, the incidence of isolated positives on MGIT differed by study laboratory (p cultures in some patients even after adjusting for laboratory, p cultures, positive MGIT cultures were more likely to be associated with higher grade TB symptoms reported within 7 days either side of sputum collection in patients with an

  14. Randomized, blinded, controlled clinical trial shows no benefit of homeopathic mastitis treatment in dairy cows. (United States)

    Ebert, Fanny; Staufenbiel, Rudolf; Simons, Julia; Pieper, Laura


    Mastitis is one of the most common diseases in dairy production, and homeopathic remedies have been used increasingly in recent years to treat it. Clinical trials evaluating homeopathy have often been criticized for their inadequate scientific approach. The objective of this triple-blind, randomized controlled trial was to assess the efficacy of homeopathic treatment in bovine clinical mastitis. The study was conducted on a conventionally managed dairy farm between June 2013 and May 2014. Dairy cows with acute mastitis were randomly allocated to homeopathy (n = 70) or placebo (n = 92), for a total of 162 animals. The homeopathic treatment was selected based on clinical symptoms but most commonly consisted of a combination of nosodes with Streptococcinum, Staphylococcinum, Pyrogenium, and Escherichia coli at a potency of 200c. Treatment was administered to cows in the homeopathy group at least once per day for an average of 5 d. The cows in the placebo group were treated similarly, using a placebo preparation instead (lactose globules without active ingredients). If necessary, we also used allopathic drugs (e.g., antibiotics, udder creams, and anti-inflammatory drugs) in both groups. We recorded data relating to the clinical signs of mastitis, treatment, time to recovery, milk yield, somatic cell count at first milk recording after mastitis, and culling. We observed cows for up to 200 d after clinical recovery. Base-level data did not differ between the homeopathy and placebo groups. Mastitis lasted for an average of 6 d in both groups. We observed no significant differences in time to recovery, somatic cell count, risk of clinical cure within 14 d after disease occurrence, mastitis recurrence risk, or culling risk. The results indicated no additional effect of homeopathic treatment compared with placebo. The advantages or disadvantages of homeopathy should be carefully assessed for individual farms. Copyright © 2017 American Dairy Science Association. Published by

  15. Robotic Assisted Radical Cystectomy with Extracorporeal Urinary Diversion Does Not Show a Benefit over Open Radical Cystectomy: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Wei Shen Tan

    Full Text Available The number of robotic assisted radical cystectomy (RARC procedures is increasing despite the lack of Level I evidence showing any advantages over open radical cystectomy (ORC. However, several systematic reviews with meta-analyses including non-randomised studies, suggest an overall benefit for RARC compared to ORC. We performed a systematic review with meta-analysis of randomised controlled trials (RCTs to evaluate the perioperative morbidity and efficacy of RARC compared to ORC in patients with bladder cancer.Literature searches of Medline/Pubmed, Embase, Web of Science and databases up to 10th March 2016 were performed. The inclusion criteria for eligible studies were RCTs which compared perioperative outcomes of ORC and RARC for bladder cancer. Primary objective was perioperative and histopathological outcomes of RARC versus ORC while the secondary objective was quality of life assessment (QoL, oncological outcomes and cost analysis.Four RCTs (from 5 articles met the inclusion criteria, with a total of 239 patients all with extracorporeal urinary diversion. Patient demographics and clinical characteristics of RARC and ORC patients were evenly matched. There was no significant difference between groups in perioperative morbidity, length of stay, positive surgical margin, lymph node yield and positive lymph node status. RARC group had significantly lower estimated blood loss (p<0.001 and wound complications (p = 0.03 but required significantly longer operating time (p<0.001. QoL was not measured uniformly across trials and cost analysis was reported in one RCTs. A test for heterogeneity did highlight differences across operating time of trials suggesting that surgeon experience may influence outcomes.This study does not provide evidence to support a benefit for RARC compared to ORC. These results may not have inference for RARC with intracorporeal urinary diversion. Well-designed trials with appropriate endpoints conducted

  16. Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine

    Directory of Open Access Journals (Sweden)

    Carter Terrell


    Full Text Available Abstract Background A pivotal phase III study of the RTS,S/AS01 malaria candidate vaccine is ongoing in several research centres across Africa. The development and establishment of quality systems was a requirement for trial conduct to meet international regulatory standards, as well as providing an important capacity strengthening opportunity for study centres. Methods Standardized laboratory methods and quality assurance processes were implemented at each of the study centres, facilitated by funding partners. Results A robust protocol for determination of parasite density based on actual blood cell counts was set up in accordance with World Health Organization recommendations. Automated equipment including haematology and biochemistry analyzers were put in place with standard methods for bedside testing of glycaemia, base excess and lactacidaemia. Facilities for X-rays and basic microbiology testing were also provided or upgraded alongside health care infrastructure in some centres. External quality assurance assessment of all major laboratory methods was established and method qualification by each laboratory demonstrated. The resulting capacity strengthening has ensured laboratory evaluations are conducted locally to the high standards required in clinical trials. Conclusion Major efforts by study centres, together with support from collaborating parties, have allowed standardized methods and robust quality assurance processes to be put in place for the phase III evaluation of the RTS, S/AS01 malaria candidate vaccine. Extensive training programmes, coupled with continuous commitment from research centre staff, have been the key elements behind the successful implementation of quality processes. It is expected these activities will culminate in healthcare benefits for the subjects and communities participating in these trials. Trial registration NCT00866619

  17. Laboratory and Field Evaluation of Biodegradable Polyesters for Sustained Release of Isometamidium and Ethidium

    Directory of Open Access Journals (Sweden)

    S Geerts


    Full Text Available An overview is presented of the results obtained with biodegradable sustained release devices (SRDs containing a mixture of polymers and either isometamidium (ISMM or ethidium. Under controlled laboratory conditions (monthly challenge with tsetse flies infected with Trypanosoma congolense the protection period in SRD treated cattle could be extended by a factor 2.8 (for ethidium up to 4.2 (for ISMM as compared to animals treated intramuscularly with the same drugs. Using a competitive drug ELISA ISMM concentrations were detected up to 330 days after the implantation of the SRDs, whereas after i.m. injection the drug was no longer present three to four months post treatment. Two field trials carried out in Mali under heavy tsetse challenge showed that the cumulative infection rate was significantly lower in the ISMM-SRD implanted cattle than in those which received ISMM intramuscularly. Using ethidium SRD, however, contradictory results were obtained in field trials in Zambia and in Mali. The potential advantages and inconvenients of the use of SRDs are discussed and suggestions are made in order to further improve the currently available devices.

  18. Implementation of External Quality Assurance Trials for Immunohistochemically Determined Breast Cancer Biomarkers in Germany. (United States)

    von Wasielewski, Reinhard; Krusche, Claudia A; Rüschoff, Joseph; Fisseler-Eckhoff, Anette; Kreipe, Hans


    Besides typing and grading of breast cancer, Pathologists are involved in the determination of biomarkers, such as steroid hormone receptors and HER2, which are of utmost importance in adjuvant therapy. There have been concerns with regard to security and reproducibility of the biomarker assays done on tissue sections applying either immunohistochemistry or in-situ hybridisation. In order to assure the quality of these biomarker assays, a number of measures are required, among them external proficiency testing. Therefore, external quality assurance trials have been implemented in Germany. In the period of 2002-2007, 5 consecutive trials were conducted with up to 180 participating laboratories. Tissue microarrays with 20-24 different breast cancer samples including cell lines enabled that a huge number of pathologists were challenged with identical samples which provides the prerequisite for comparability. Because there is no legal duress to undergo external proficiency testing in histopathology, all laboratories that took part volunteered to do so. These innovative quality assurance trials (Qualitätsinitiative Pathologie, QuIP) will be continued in the future on an annual or bi-annual basis. Participation is recommended for pathology departments involved in the service for breast units. The organisational frame work of the trials is described here.

  19. PBI creams: a spontaneously mutated mouse strain showing wild animal-type reactivity. (United States)

    Hendrie, C A; Van Driel, K S; Talling, J C; Inglis, I R


    PBI creams are mice derived from warfarin-resistant wild stock that has been maintained under laboratory conditions since the 1970s. This study compares their behaviour to that of laboratory mice and wild house and wood mice. Animals were tested in a black/white box and a 2.64x1.4 m runway. In the black/white box, the behaviour of PBI creams was not significantly different from that of house mice and differed most from that of laboratory mice. Notably, the PBI creams showed the greatest activity and escape-orientated behaviours. When animals were approached by the experimenter in the open runway test, the PBI creams had higher flight speeds than both house and wood mice, whilst laboratory mice failed to respond. In the closed runway test where the animals could not escape, the PBI creams, house mice and wood mice all turned and attempted to run past the approaching experimenter, whilst the laboratory mice again failed to react. At the end of this test session, the time taken to catch each animal was recorded. It took less than 5 s to catch laboratory mice but significantly longer to catch the wild strains and the PBI creams (90-100 s for the latter). In these tests, the PBI creams showed wild animal-type reactivity, and as this behaviour has been retained in the laboratory colony for over 30 years, these animals may be useful in the study of the physiological and genetic basis of fear/anxiety in mice.

  20. Sustainable development of a GCP-compliant clinical trials platform in Africa: the malaria clinical trials alliance perspective. (United States)

    Ogutu, Bernhards R; Baiden, Rita; Diallo, Diadier; Smith, Peter G; Binka, Fred N


    The Malaria Clinical Trials Alliance (MCTA), a programme of INDEPTH network of demographic surveillance centres, was launched in 2006 with two broad objectives: to facilitate the timely development of a network of centres in Africa with the capacity to conduct clinical trials of malaria vaccines and drugs under conditions of good clinical practice (GCP); and to support, strengthen and mentor the centres in the network to facilitate their progression towards self-sustaining clinical research centres. Sixteen research centres in 10 African malaria-endemic countries were selected that were already working with the Malaria Vaccine Initiative (MVI) or the Medicines for Malaria Venture (MMV). All centres were visited to assess their requirements for research capacity development through infrastructure strengthening and training. Support provided by MCTA included: laboratory and facility refurbishment; workshops on GCP, malaria diagnosis, strategic management and media training; and training to support staff to undertake accreditation examinations of the Association of Clinical Research Professionals (ACRP). Short attachments to other network centres were also supported to facilitate sharing practices within the Alliance. MCTA also played a key role in the creation of the African Media & Malaria Research Network (AMMREN), which aims to promote interaction between researchers and the media for appropriate publicity and media reporting of research and developments on malaria, including drug and vaccine trials. In three years, MCTA strengthened 13 centres to perform GCP-compliant drug and vaccine trials, including 11 centres that form the backbone of a large phase III malaria vaccine trial. MCTA activities have demonstrated that centres can be brought up to GCP compliance on this time scale, but the costs are substantial and there is a need for further support of other centres to meet the growing demand for clinical trial capacity. The MCTA experience also indicates that

  1. Implementing the Science Assessment Standards: Developing and validating a set of laboratory assessment tasks in high school biology (United States)

    Saha, Gouranga Chandra

    Very often a number of factors, especially time, space and money, deter many science educators from using inquiry-based, hands-on, laboratory practical tasks as alternative assessment instruments in science. A shortage of valid inquiry-based laboratory tasks for high school biology has been cited. Driven by this need, this study addressed the following three research questions: (1) How can laboratory-based performance tasks be designed and developed that are doable by students for whom they are designed/written? (2) Do student responses to the laboratory-based performance tasks validly represent at least some of the intended process skills that new biology learning goals want students to acquire? (3) Are the laboratory-based performance tasks psychometrically consistent as individual tasks and as a set? To answer these questions, three tasks were used from the six biology tasks initially designed and developed by an iterative process of trial testing. Analyses of data from 224 students showed that performance-based laboratory tasks that are doable by all students require careful and iterative process of development. Although the students demonstrated more skill in performing than planning and reasoning, their performances at the item level were very poor for some items. Possible reasons for the poor performances have been discussed and suggestions on how to remediate the deficiencies have been made. Empirical evidences for validity and reliability of the instrument have been presented both from the classical and the modern validity criteria point of view. Limitations of the study have been identified. Finally implications of the study and directions for further research have been discussed.

  2. Trial of Immune Globulin in Infant Botulism

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap


    Full Text Available A 5-year, randomized, double-blind, placebo-controlled trial of the orphan drug Human Botulism Immune Globulin Intravenous (BIG-IV in 122 infants in California with confirmed infant botulism (75 caused by type A Clostridium botulinum toxin, and 47 by type B toxin was conducted at the California Department of Health Services, Richmond, CA; National Botulism Surveillance and Reference Laboratory, CDC and P, Atlanta; and Division of Biostatistics, University of California, Berkeley.

  3. Phase 1 trial of vamorolone, a first-in-class steroid, shows improvements in side effects via biomarkers bridged to clinical outcomes. (United States)

    Hoffman, Eric P; Riddle, Valerie; Siegler, Maxime A; Dickerson, Daniel; Backonja, Miroslav; Kramer, William G; Nagaraju, Kanneboyina; Gordish-Dressman, Heather; Damsker, Jesse M; McCall, John M


    Glucocorticoid drugs are highly effective anti-inflammatory agents, but chronic use is associated with extensive pharmacodynamic safety concerns that have a considerable negative impact on patient quality of life. Vamorolone (VBP15) is a first-in-class steroidal multi-functional drug that shows potent inhibition of pro-inflammatory NFkB pathways via high-affinity binding to the glucocorticoid receptor, high affinity antagonism for the mineralocorticoid receptor, and membrane stabilization properties. Pre-clinical data in multiple mouse models of inflammation showed retention of anti-inflammatory efficacy, but loss of most or all side effects. We report first-in-human Phase 1 clinical trials (86 healthy adult males), with single ascending doses (0.1-20.0 mg/kg), and multiple ascending doses (1.0-20 mg/kg/day; 14 days treatment). Vamorolone was well-tolerated at all dose levels. Vamorolone showed pharmacokinetic and metabolism profiles similar to prednisone. Biomarker studies showed loss of side effects of traditional glucocorticoid drugs (bone fragility, metabolic disturbance, immune suppression). Suppression of the adrenal axis was 10-fold less than prednisone. The crystallographic structure of vamorolone was solved, and compared to prednisone and dexamethasone. There was overlap in structure, but differences in conformation at the C-ring where glucocorticoids interact with Asn564 of the glucocorticoid receptor. The predicted loss of Asn564 binding to vamorolone may underlie the loss of gene transcriptional activity. Vamorolone is a dissociative steroid that retains high affinity binding and nuclear translocation of both glucocorticoid (agonist) and mineralocorticoid (antagonist) receptors, but does not show pharmacodynamic safety concerns of existing glucocorticoid drugs at up to 20 mg/kg/day. Copyright © 2018 The Author(s). Published by Elsevier Inc. All rights reserved.

  4. Clinical pharmacology quality assurance program: models for longitudinal analysis of antiretroviral proficiency testing for international laboratories. (United States)

    DiFrancesco, Robin; Rosenkranz, Susan L; Taylor, Charlene R; Pande, Poonam G; Siminski, Suzanne M; Jenny, Richard W; Morse, Gene D


    Among National Institutes of Health HIV Research Networks conducting multicenter trials, samples from protocols that span several years are analyzed at multiple clinical pharmacology laboratories (CPLs) for multiple antiretrovirals. Drug assay data are, in turn, entered into study-specific data sets that are used for pharmacokinetic analyses, merged to conduct cross-protocol pharmacokinetic analysis, and integrated with pharmacogenomics research to investigate pharmacokinetic-pharmacogenetic associations. The CPLs participate in a semiannual proficiency testing (PT) program implemented by the Clinical Pharmacology Quality Assurance program. Using results from multiple PT rounds, longitudinal analyses of recovery are reflective of accuracy and precision within/across laboratories. The objectives of this longitudinal analysis of PT across multiple CPLs were to develop and test statistical models that longitudinally: (1) assess the precision and accuracy of concentrations reported by individual CPLs and (2) determine factors associated with round-specific and long-term assay accuracy, precision, and bias using a new regression model. A measure of absolute recovery is explored as a simultaneous measure of accuracy and precision. Overall, the analysis outcomes assured 97% accuracy (±20% of the final target concentration of all (21) drug concentration results reported for clinical trial samples by multiple CPLs). Using the Clinical Laboratory Improvement Act acceptance of meeting criteria for ≥2/3 consecutive rounds, all 10 laboratories that participated in 3 or more rounds per analyte maintained Clinical Laboratory Improvement Act proficiency. Significant associations were present between magnitude of error and CPL (Kruskal-Wallis P Kruskal-Wallis P < 0.001).

  5. External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance.

    Directory of Open Access Journals (Sweden)

    Sean C Murphy

    Full Text Available Nucleic acid testing (NAT for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally <0.5 log10 parasites/mL except for one laboratory where the EQA effort identified likely reasons for a general quantitative shift. The within-laboratory variation for all assays was low at <10% coefficient of variation across a range of parasite densities. Based on this study, we propose to create a Molecular Malaria Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide.

  6. Clinical Trials

    Medline Plus

    Full Text Available ... records can quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines ... and materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. ( ...

  8. The relaxation exercise and social support trial-resst: study protocol for a randomized community based trial

    Directory of Open Access Journals (Sweden)

    Nakkash Rima


    Full Text Available Abstract Background Studies suggests a possible link between vaginal discharge and common mental distress, as well as highlight the implications of the subjective burden of disease and its link with mental health. Methods/Design This is a community-based intervention trial that aims to evaluate the impact of a psycho-social intervention on medically unexplained vaginal discharge (MUVD in a group of married, low-income Lebanese women, aged 18-49, and suffering from low to moderate levels of anxiety and/or depression. The intervention consisted of 12 sessions of structured social support, problem solving techniques, group discussions and trainer-supervised relaxation exercises (twice per week over six weeks. Women were recruited from Hey el Selloum, a southern disadvantaged suburb of Beirut, Lebanon, during an open recruitment campaign. The primary outcome was self-reported MUVD, upon ruling out reproductive tract infections (RTIs, through lab analysis. Anxiety and/or depression symptoms were the secondary outcomes for this trial. These were assessed using an Arabic validated version of the Hopkins Symptoms Checklist-25 (HSCL-25. Assessments were done at baseline and six months using face-to face interviews, pelvic examinations and laboratory tests. Women were randomized into either intervention or control group. Intent to treat analysis will be used. Discussion The results will indicate whether the proposed psychosocial intervention was effective in reducing MUVD (possibly mediated by common mental distress. Trial Registration The trial is registered at the Wellcome Trust Registry, ISRCTN assigned: ISRCTN: ISRCTN98441241

  9. Productivity of Veterans Health Administration laboratories: a College of American Pathologists Laboratory Management Index Program (LMIP) study. (United States)

    Valenstein, Paul N; Wang, Edward; O'Donohue, Tom


    The Veterans Health Administration (VA) operates the largest integrated laboratory network in the United States. To assess whether the unique characteristics of VA laboratories impact efficiency of operations, we compared the productivity of VA and non-VA facilities. Financial and activity data were prospectively collected from 124 VA and 131 non-VA laboratories enrolled in the College of American Pathologists Laboratory Management Index Program (LMIP) during 2002. In addition, secular trends in 5 productivity ratios were calculated for VA and non-VA laboratories enrolled in LMIP from 1997 through 2002. Veterans Health Administration and non-VA facilities did not differ significantly in size. Inpatients accounted for a lower percentage of testing at VA facilities than non-VA facilities (21.7% vs 37.3%; P benefits; P depreciation, and maintenance than their non-VA counterparts (all P <.001), resulting in lower overall cost per on-site test result (2.64 dollars vs 3.40 dollars; P <.001). Cost per referred (sent-out) test did not differ significantly between the 2 groups. Analysis of 6-year trends showed significant increases in both VA (P <.001) and non-VA (P =.02) labor productivity (on-site tests/total FTE). Expenses at VA laboratories for labor per test, consumables per test, overall expense per test, and overall laboratory expense per discharge decreased significantly during the 6-year period (P <.001), while in non-VA facilities the corresponding ratios showed no significant change. Overall productivity of VA laboratories is superior to that of non-VA facilities enrolled in LMIP. The principal advantages enjoyed by the VA are higher-than-average labor productivity (tests/FTE) and lower-than-average consumable expenses.

  10. Laboratory Safety in the Biology Lab. (United States)

    Ritch, Donna; Rank, Jane


    Reports on a research project to determine if students possess and comprehend basic safety knowledge. Shows a significant increase in the amount of safety knowledge gained when students are exposed to various topics in laboratory safety and are held accountable for learning the information as required in a laboratory safety course. (Author/MM)

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

    Directory of Open Access Journals (Sweden)

    Emili Balaguer-Ballester

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

  12. Lab Plays Central Role in Groundbreaking National Clinical Trial in Precision Medicine | Frederick National Laboratory for Cancer Research (United States)

    The Molecular Characterization Laboratory at the Frederick National Laboratory for Cancer Research lies at the heart of an ambitious new approach for testing cancer drugs that will use the newest tools of precision medicine to select the best treatme

  13. Grey literature in meta-analyses of randomized trials of health care interventions. (United States)

    Hopewell, S; McDonald, S; Clarke, M; Egger, M


    The inclusion of grey literature (i.e. literature that has not been formally published) in systematic reviews may help to overcome some of the problems of publication bias, which can arise due to the selective availability of data. To review systematically research studies, which have investigated the impact of grey literature in meta-analyses of randomized trials of health care interventions. We searched the Cochrane Methodology Register (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to 20 May 2005), the Science Citation Index (June 2005) and contacted researchers who may have carried out relevant studies. A study was considered eligible for this review if it compared the effect of the inclusion and exclusion of grey literature on the results of a cohort of meta-analyses of randomized trials. Data were extracted from each report independently by two reviewers. The main outcome measure was an estimate of the impact of trials from the grey literature on the pooled effect estimates of the meta-analyses. Information was also collected on the area of health care, the number of meta-analyses, the number of trials, the number of trial participants, the year of publication of the trials, the language and country of publication of the trials, the number and type of grey and published literature, and methodological quality. Five studies met the inclusion criteria. All five studies showed that published trials showed an overall greater treatment effect than grey trials. This difference was statistically significant in one of the five studies. Data could be combined for three of the five studies. This showed that, on average, published trials showed a 9% greater treatment effect than grey trials (ratio of odds ratios for grey versus published trials 1.09; 95% CI 1.03-1.16). Overall there were more published trials included in the meta-analyses than grey trials (median 224 (IQR 108-365) versus 45(IQR 40-102)). Published trials had more participants on average. The most

  14. Phoenix's Wet Chemistry Laboratory Units (United States)


    This image shows four Wet Chemistry Laboratory units, part of the Microscopy, Electrochemistry, and Conductivity Analyzer (MECA) instrument on board NASA's Phoenix Mars Lander. This image was taken before Phoenix's launch on August 4, 2007. The Phoenix Mission is led by the University of Arizona, Tucson, on behalf of NASA. Project management of the mission is by NASA's Jet Propulsion Laboratory, Pasadena, Calif. Spacecraft development is by Lockheed Martin Space Systems, Denver.

  15. A randomized, placebo-controlled trial of memantine for functional disability in amyotrophic lateral sclerosis. (United States)

    de Carvalho, Mamede; Pinto, Susana; Costa, João; Evangelista, Teresinha; Ohana, Bemjamim; Pinto, Anabela


    Our objective is to describe the results of a phase II/III, 12-months, double-blinded, single-centre, randomized, parallel (1:1), clinical trial performed to evaluate the efficacy and safety of memantine in ALS. Patients with probable or definite ALS of less than 36 months disease duration and progression over a one-month lead-in period were randomly assigned to placebo or memantine at 20 mg/day. The primary endpoint was 12-months ALSFRS decline. Forced vital capacity, manual muscle testing, visual analogue scale, quality of life, motor unit number estimation and neurophysiological index were the secondary endpoints. The number of patients included was based on the assumption of a 50% change in the ALSFRS decline. Safety and adverse events were evaluated. Sixty-three patients were included in the trial. Memantine did not show more adverse events or laboratory changes than placebo. Primary and secondary outcomes were not different between groups by intention-to-treat and per-protocol analysis. The most sensitive measurements were neurophysiological, which declined linearly over time. In conclusion, the results of this study show that memantine is well tolerated and safe in ALS patients. We did not observe any evidence of efficacy for memantine but we cannot exclude a positive outcome on survival.

  16. Nontyphoidal Salmonella: An Occupational Hazard for Clinical Laboratory Workers


    Barker, Anna; Duster, Megan; Van Hoof, Sarah; Safdar, Nasia


    Laboratory-acquired infections due to nontyphoidal Salmonella are rare. Yet, recent outbreaks in microbiology teaching laboratories show that these species are still an appreciable occupational hazard for laboratory employees. This article presents two cases of nontyphoidal Salmonella that occurred at the authors' institution—an infected patient and a clinical laboratory worker who acquired the infection by handling this patient's specimens.

  17. Effective teaching of manual skills to physiotherapy students: a randomised clinical trial. (United States)

    Rossettini, Giacomo; Rondoni, Angie; Palese, Alvisa; Cecchetto, Simone; Vicentini, Marco; Bettale, Fernanda; Furri, Laura; Testa, Marco


    To date, despite the relevance of manual skills laboratories in physiotherapy education, evidence on the effectiveness of different teaching methods is limited. Peyton's four-step and the 'See one, do one' approaches were compared for their effectiveness in teaching manual skills. A cluster randomised controlled trial was performed among final-year, right-handed physiotherapy students, without prior experience in manual therapy or skills laboratories. The manual technique of C1-C2 passive right rotation was taught by different experienced physiotherapist using Peyton's four-step approach (intervention group) and the 'See one, do one' approach (control group). Participants, teachers and assessors were blinded to the aims of the study. Primary outcomes were quality of performance at the end of the skills laboratories, and after 1 week and 1 month. Secondary outcomes were time required to teach, time required to perform the procedure and student satisfaction. A total of 39 students were included in the study (21 in the intervention group and 18 in the control group). Their main characteristics were homogeneous at baseline. The intervention group showed better quality of performance in the short, medium and long terms (F 1,111  = 35.91, p physiotherapy student competence in C1-C2 passive mobilisation. © 2017 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

  18. A randomised trial of enteral glutamine supplementation for very preterm children showed no beneficial or adverse long-term neurodevelopmental outcomes

    NARCIS (Netherlands)

    Twilhaar, E.S.; de Kieviet, J.F.; Oosterlaan, J.; van Elburg, R.M.


    Aim This study evaluated the long-term effects of enteral glutamine supplementation on neurodevelopmental outcomes of a Dutch cohort of very preterm children at 13 years of age. Methods The cohort was enrolled in a randomised placebo-controlled trial between 2001 and 2003 in which infants received

  19. A randomised trial of enteral glutamine supplementation for very preterm children showed no beneficial or adverse long-term neurodevelopmental outcomes

    NARCIS (Netherlands)

    Twilhaar, E. Sabrina; de Kieviet, Jorrit F.; Oosterlaan, Jaap; van Elburg, Ruurd M.


    This study evaluated the long-term effects of enteral glutamine supplementation on neurodevelopmental outcomes of a Dutch cohort of very preterm children at 13 years of age. The cohort was enrolled in a randomised placebo-controlled trial between 2001-2003 in which infants received glutamine- or

  20. Introduction to a Special Issue of the Journal of Immunological Methods: Building global resource programs to support HIV/AIDS clinical trial studies. (United States)

    Sanchez, Ana M; Denny, Thomas N; O'Gorman, Maurice


    This Special Issue of the Journal of Immunological Methods includes 16 manuscripts describing quality assurance activities related to virologic and immunologic monitoring of six global laboratory resource programs that support international HIV/AIDS clinical trial studies: Collaboration for AIDS Vaccine Discovery (CAVD); Center for HIV/AIDS Vaccine Immunology (CHAVI); External Quality Assurance Program Oversight Laboratory (EQAPOL); HIV Vaccine Trial Network (HVTN); International AIDS Vaccine Initiative (IAVI); and Immunology Quality Assessment (IQA). The reports from these programs address the many components required to develop comprehensive quality control activities and subsequent quality assurance programs for immune monitoring in global clinical trials including: all aspects of processing, storing, and quality assessment of PBMC preparations used ubiquitously in HIV clinical trials, the development and optimization of assays for CD8 HIV responses and HIV neutralization, a comprehensive global HIV virus repository, and reports on the development and execution of novel external proficiency testing programs for immunophenotyping, intracellular cytokine staining, ELISPOT and luminex based cytokine measurements. In addition, there are articles describing the implementation of Good Clinical Laboratory Practices (GCLP) in a large quality assurance laboratory, the development of statistical methods specific for external proficiency testing assessment, a discussion on the ability to set objective thresholds for measuring rare events by flow cytometry, and finally, a manuscript which addresses a framework for the structured reporting of T cell immune function based assays. It is anticipated that this series of manuscripts covering a wide range of quality assurance activities associated with the conduct of global clinical trials will provide a resource for individuals and programs involved in improving the harmonization, standardization, accuracy, and sensitivity of

  1. Pilot trial on separation conditions for diaper recycling. (United States)

    Kim, Kyung-Shin; Cho, Hee-Sun


    By utilizing laboratory-scale tests, the optimal separation conditions for diaper recycling were identified, and then, these conditions were validated by a pilot trial. In this research, we determined the mass balances derived during various processing steps and identified the most feasible procedures to use for separating each material in the output flow. The results showed that drum screening was not able to remove all the fiber and super absorbent particles (SAP) in the plastic-rich fraction and that cellulose enzyme treatment can be a good solution. To achieve better separation of fibers and SAP, slot screening followed by a cleaner is a potential option. A feasible diaper recycling process was recommended based on these results. This process involves screening and enzymatic treatment for the plastic fraction, and screening, cleaning, and thickening for the fiber fraction. Treatment procedures were also proposed for the SAP fraction and rejected materials. Copyright © 2017. Published by Elsevier Ltd.

  2. A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia (United States)

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


    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:, 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

  3. Feasibility of establishing a biosafety level 3 tuberculosis culture laboratory of acceptable quality standards in a resource-limited setting: an experience from Uganda. (United States)

    Ssengooba, Willy; Gelderbloem, Sebastian J; Mboowa, Gerald; Wajja, Anne; Namaganda, Carolyn; Musoke, Philippa; Mayanja-Kizza, Harriet; Joloba, Moses Lutaakome


    Despite the recent innovations in tuberculosis (TB) and multi-drug resistant TB (MDR-TB) diagnosis, culture remains vital for difficult-to-diagnose patients, baseline and end-point determination for novel vaccines and drug trials. Herein, we share our experience of establishing a BSL-3 culture facility in Uganda as well as 3-years performance indicators and post-TB vaccine trials (pioneer) and funding experience of sustaining such a facility. Between September 2008 and April 2009, the laboratory was set-up with financial support from external partners. After an initial procedure validation phase in parallel with the National TB Reference Laboratory (NTRL) and legal approvals, the laboratory registered for external quality assessment (EQA) from the NTRL, WHO, National Health Laboratories Services (NHLS), and the College of American Pathologists (CAP). The laboratory also instituted a functional quality management system (QMS). Pioneer funding ended in 2012 and the laboratory remained in self-sustainability mode. The laboratory achieved internationally acceptable standards in both structural and biosafety requirements. Of the 14 patient samples analyzed in the procedural validation phase, agreement for all tests with NTRL was 90% (P 80% in all years from NTRL, CAP, and NHLS, and culture was 100% for CAP panels and above regional average scores for all years with NHLS. Quarterly DST scores from WHO-EQA ranged from 78% to 100% in 2010, 80% to 100% in 2011, and 90 to 100% in 2012. From our experience, it is feasible to set-up a BSL-3 TB culture laboratory with acceptable quality performance standards in resource-limited countries. With the demonstrated quality of work, the laboratory attracted more research groups and post-pioneer funding, which helped to ensure sustainability. The high skilled experts in this research laboratory also continue to provide an excellent resource for the needed national discussion of the laboratory and quality management systems.

  4. Single-Trial Inference on Visual Attention

    DEFF Research Database (Denmark)

    Dyrholm, Mads; Kyllingsbæk, Søren; Vangkilde, Signe Allerup


    In this paper we take a step towards single-trial behavioral modeling within a Theory of Visual Attention (TVA). In selective attention tasks, such as the Partial Report paradigm, the subject is asked to ignore distractors and only report stimuli that belong to the target class. Nothing about...... Report trial. This result retrodicts a latent attentional state of the subject using the observed response from that particular trial and thus differs from other predictions made with TVA which are based on expected values of observed variables. We show an example of the result in single-trial analysis...

  5. Predicting skin sensitization potential and inter-laboratory reproducibility of a human Cell Line Activation Test (h-CLAT) in the European Cosmetics Association (COLIPA) ring trials. (United States)

    Sakaguchi, Hitoshi; Ryan, Cindy; Ovigne, Jean-Marc; Schroeder, Klaus R; Ashikaga, Takao


    Regulatory policies in Europe prohibited the testing of cosmetic ingredients in animals for a number of toxicological endpoints. Currently no validated non-animal test methods exist for skin sensitization. Evaluation of changes in cell surface marker expression in dendritic cell (DC)-surrogate cell lines represents one non-animal approach. The human Cell Line Activation Test (h-CLAT) examines the level of CD86 and CD54 expression on the surface of THP-1 cells, a human monocytic leukemia cell line, following 24h of chemical exposure. To examine protocol transferability, between-lab reproducibility, and predictive capacity, the h-CLAT has been evaluated by five independent laboratories in several ring trials (RTs) coordinated by the European Cosmetics Association (COLIPA). The results of the first and second RTs demonstrated that the protocol was transferable and basically had good between-lab reproducibility and predictivity, but there were some false negative data. To improve performance, protocol and prediction model were modified. Using the modified prediction model in the first and second RT, accuracy was improved. However, about 15% of the outcomes were not correctly identified, which exposes some of the limitations of the assay. For the chemicals evaluated, the limitation may due to chemical being a weak allergen or having low solubility (ex. alpha-hexylcinnamaldehyde). The third RT evaluated the modified prediction model and satisfactory results were obtained. From the RT data, the feasibility of utilizing cell lines as surrogate DC in development of in vitro skin sensitization methods shows promise. The data also support initiating formal pre-validation of the h-CLAT in order to fully understand the capabilities and limitations of the assay. Copyright 2010 Elsevier Ltd. All rights reserved.

  6. Clinical Trials

    Medline Plus

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

  7. Blood pressure response to caffeine shows incomplete tolerance after short-term regular consumption. (United States)

    Lovallo, William R; Wilson, Michael F; Vincent, Andrea S; Sung, Bong Hee; McKey, Barbara S; Whitsett, Thomas L


    Caffeine acutely raises blood pressure (BP). The clinical significance of this effect depends on whether BP responses persist in persons who consume caffeine on a daily basis. Accordingly, the ability of caffeine to raise BP after 5 days of regular daily intake was tested in a randomized controlled trial. Individual differences in tolerance formation were then examined. Men (n=49) and women (n=48) completed a double-blind, crossover trial conducted over 4 weeks. During each week, subjects abstained for 5 days from dietary caffeine and instead used capsules totaling 0 mg, 300 mg, and 600 mg of caffeine per day in 3 divided doses. On day 6, in the laboratory, they used capsules with either 0 mg or 250 mg of caffeine at 9:00 am and 1:00 pm. Systolic/diastolic BP increases as a result of 250 mg of caffeine remained significant (P7.90, P <0.001). The sexes did not differ in degree of tolerance formation. Daily caffeine consumption failed to eliminate the BP response to repeated challenge doses of caffeine in half of the healthy adults who were tested. Caffeine may therefore cause persistent BP effects in persons who are regular consumers, even when daily intake is at moderately high levels.

  8. Acceleration to failure in geophysical signals prior to laboratory rock failure and volcanic eruptions (Invited) (United States)

    Main, I. G.; Bell, A. F.; Greenhough, J.; Heap, M. J.; Meredith, P. G.


    The nucleation processes that ultimately lead to earthquakes, volcanic eruptions, rock bursts in mines, and landslides from cliff slopes are likely to be controlled at some scale by brittle failure of the Earth’s crust. In laboratory brittle deformation experiments geophysical signals commonly exhibit an accelerating trend prior to dynamic failure. Similar signals have been observed prior to volcanic eruptions, including volcano-tectonic earthquake event and moment release rates. Despite a large amount of effort in the search, no such statistically robust systematic trend is found prior to natural earthquakes. Here we describe the results of a suite of laboratory tests on Mount Etna Basalt and other rocks to examine the nature of the non-linear scaling from laboratory to field conditions, notably using laboratory ‘creep’ tests to reduce the boundary strain rate to conditions more similar to those in the field. Seismic event rate, seismic moment release rate and rate of porosity change show a classic ‘bathtub’ graph that can be derived from a simple damage model based on separate transient and accelerating sub-critical crack growth mechanisms, resulting from separate processes of negative and positive feedback in the population dynamics. The signals exhibit clear precursors based on formal statistical model tests using maximum likelihood techniques with Poisson errors. After correcting for the finite loading time of the signal, the results show a transient creep rate that decays as a classic Omori law for earthquake aftershocks, and remarkably with an exponent near unity, as commonly observed for natural earthquake sequences. The accelerating trend follows an inverse power law when fitted in retrospect, i.e. with prior knowledge of the failure time. In contrast the strain measured on the sample boundary shows a less obvious but still accelerating signal that is often absent altogether in natural strain data prior to volcanic eruptions. To test the

  9. Laboratory 3.0: Manufacturing technologies laboratory virtualization with a student-centred methodology

    Directory of Open Access Journals (Sweden)

    Albert Fabregat-Sanjuan


    Full Text Available This paper presents a blended-learning strategy for improving the teaching method applied in the laboratory subject Manufacturing Technologies. The teaching method has been changed from a predominantly teacher-centred to an active learning system with a student-centred focus and e-learning activities. In face-to-face classes, a game-based learning platform has been used. This methodology ensured engaging classes at the same time that provided a useful live feedback for students and teachers. The virtualization of the laboratory was achieved by two different e-learning activities, self-assessment tasks and video clips. These e-learning tools have been used not only to improve the students’ learning but also to enhance their motivation. The results from academic outputs show a significant improvement after the new blended learning method is applied. Moreover, a student satisfaction survey shows the positive impact of the methodology on the students’ engagement and motivation.

  10. Clinical Trials

    Medline Plus

    Full Text Available ... a laboratory (lab), where scientists first develop and test new ideas. If an approach seems promising, the next step may involve animal testing. This shows how the approach affects a ...

  11. Multicenter Collaborative Trial Evaluation of a Method for Detection of Human Adenoviruses in Berry Fruit

    NARCIS (Netherlands)

    Agostino, D' C.; Cook, N.; Bartolo, Di I.; Ruggeri, F.M.; Berto, A.; Martelli, F.; Banks, M.; Vasickova, P.; Kralik, P.; Pavlik, I.; Kokkinos, P.; Vantarakis, A.; Söderberg, K.; Maunula, L.; Verhaelen, K.; Rutjes, S.; Roda Husman, De A.M.; Hakze-van der Honing, van der R.W.; Poel, van der W.H.M.; Kaupke, A.; Kozyra, I.; Rzezutka, A.; Prodanov, J.; Lazic, S.; Petrovic, T.; Carratala, A.; Gironés, R.; Diez-Valcarce, M.; Hernandez, M.; Rodriguez-Lazaro, D.


    The qualitative performance characteristics of a qPCR-based method to detect human adenoviruses in raspberries were determined through a collaborative trial involving 11 European laboratories. The method incorporated a sample process control (murine norovirus) and an internal amplification control.

  12. Market trials of irradiated chicken

    International Nuclear Information System (INIS)

    Fox, John A.; Olson, Dennis G.


    The potential market for irradiated chicken breasts was investigated using a mail survey and a retail trial. Results from the mail survey suggested a significantly higher level of acceptability of irradiated chicken than did the retail trial. A subsequent market experiment involving actual purchases showed levels of acceptability similar to that of the mail survey when similar information about food irradiation was provided

  13. Retention of the "first-trial effect" in gait-slip among community-living older adults. (United States)

    Liu, Xuan; Bhatt, Tanvi; Wang, Shuaijie; Yang, Feng; Pai, Yi-Chung Clive


    "First-trial effect" characterizes the rapid adaptive behavior that changes the performance outcome (from fall to non-fall) after merely a single exposure to postural disturbance. The purpose of this study was to investigate how long the first-trial effect could last. Seventy-five (≥ 65 years) community-dwelling older adults, who were protected by an overhead full body harness system, were retested for a single slip 6-12 months after their initial exposure to a single gait-slip. Subjects' body kinematics that was used to compute their proactive (feedforward) and reactive (feedback) control of stability was recorded by an eight-camera motion analysis system. We found the laboratory falls of subjects on their retest slip were significantly lower than that on the novel initial slip, and the reactive stability of these subjects was also significantly improved. However, the proactive stability of subjects remains unchanged between their initial slip and retest slip. The fall rates and stability control had no difference among the 6-, 9-, and 12-month retest groups, which indicated a maximum retention on 12 months after a single slip in the laboratory. These results highlighted the importance of the "first-trial effect" and suggested that perturbation training is effective for fall prevention, with lower trial doses for a long period (up to 1 year). Therefore, single slip training might benefit those older adults who could not tolerate larger doses in reality.

  14. Text Messaging Improves Participation in Laboratory Testing in Adolescent Liver Transplant Patients. (United States)

    McKenzie, Rebecca B; Berquist, William E; Foley, Megan A; Park, K T; Windsheimer, Jered E; Litt, Iris F

    In solid organ transplant patients, non-participation in all aspects of the medical regimen is a prevalent problem associated with adverse consequences particularly in the adolescent and young adult (AYA) age group. This study is the first to evaluate the feasibility, utility and impact of a text messaging (TM) intervention to improve participation in laboratory testing in adolescent liver transplant patients. AYA patients, aged 12 to 21 years, were recruited for a prospective pilot trial evaluating a TM intervention delivered over a 1-year period. The intervention involved automated TM reminders with feedback administered according to a prescribed laboratory testing frequency. Participation rate in laboratory testing after the intervention was compared to the year prior. Patient responses and feedback by text and survey were used to assess feasibility, acceptability and use of the intervention. Forty-two patients were recruited and 33 patients remained enrolled for the study duration. Recipients of the TM intervention demonstrated a significant improvement in participation rate in laboratory testing from 58% to 78% (Prate was also significantly higher than in non-intervention controls (P=.003). There was a high acceptability, response rate and a significant correlation with reported versus actual completion of laboratory tests by TM. TM reminders significantly improved participation in laboratory testing in AYA liver transplant patients. The intervention demonstrated feasibility, acceptability, and use with a high proportion of patients who engaged in and perceived a benefit from using this technology.

  15. Implementation of a new 'community' laboratory CD4 service in a rural health district in South Africa extends laboratory services and substantially improves local reporting turnaround time. (United States)

    Coetzee, L M; Cassim, N; Glencross, D K


    The CD4 integrated service delivery model (ITSDM) provides for reasonable access to pathology services across South Africa (SA) by offering three new service tiers that extend services into remote, under-serviced areas. ITSDM identified Pixley ka Seme as such an under-serviced district. To address the poor service delivery in this area, a new ITSDM community (tier 3) laboratory was established in De Aar, SA. Laboratory performance and turnaround time (TAT) were monitored post implementation to assess the impact on local service delivery. Using the National Health Laboratory Service Corporate Data Warehouse, CD4 data were extracted for the period April 2012-July 2013 (n=11,964). Total mean TAT (in hours) was calculated and pre-analytical and analytical components assessed. Ongoing testing volumes, as well as external quality assessment performance across ten trials, were used to indicate post-implementation success. Data were analysed using Stata 12. Prior to the implementation of CD4 testing at De Aar, the total mean TAT was 20.5 hours. This fell to 8.2 hours post implementation, predominantly as a result of a lower pre-analytical mean TAT reducing from a mean of 18.9 to 1.8 hours. The analytical testing TAT remained unchanged after implementation and monthly test volumes increased by up to 20%. External quality assessment indicated adequate performance. Although subjective, questionnaires sent to facilities reported improved service delivery. Establishing CD4 testing in a remote community laboratory substantially reduces overall TAT. Additional community CD4 laboratories should be established in under-serviced areas, especially where laboratory infrastructure is already in place.

  16. The behavior of an opponent alters pacing decisions in 4-km cycling time trials. (United States)

    Konings, Marco J; Schoenmakers, Patrick P J M; Walker, Andrew J; Hettinga, Florentina J


    The present study aimed to explore how athletes respond to different behaviors of their opponents. Twelve moderately to highly physically active participants with at least two years of cycling experience completed four 4-km time trials on a Velotron cycle ergometer. After a familiarization time trial (FAM), participants performed three experimental time trials in randomized order with no opponent (NO), a virtual opponent who started slower and finished faster compared to FAM (OP-SLOWFAST), or a virtual opponent who started faster and finished slower compared to FAM (OP-FASTSLOW). Repeated-measures ANOVAs (Ppower output, velocity and RPE. OP-SLOWFAST and OP-FASTSLOW were completed faster compared to NO (385.5±27.5, 385.0±28.6, and 390.6±29.3s, respectively). An interaction effect for condition×distance (F=3.944, Ppower outputs by the participants in the initial 750m compared to a slower starting opponent. The present study is the first to show that the behavior of an opponent affects pacing-related decisions in laboratory-controlled conditions. Our findings support the recently proposed interdependence of perception and action, and emphasize the interaction with the environment as an important determinant for an athlete's pacing decisions, especially during the initial stages of a race. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Quality assurance handbook for measurement laboratories

    International Nuclear Information System (INIS)

    Delvin, W.L.


    This handbook provides guidance in the application of quality assurance to measurement activities. It is intended to help those persons making measurements in applying quality assurance to their work activities by showing how laboratory practices and quality assurance requirements are integrated to provide control within those activities. The use of the guidance found in this handbook should help provide consistency in the interpretation of quality assurance requirements across all types of measurement laboratories. This handbook also can assist quality assurance personnel in understanding the relationships between laboratory practices and quality assurance requirements. The handbook is composed of three chapters and several appendices. Basic guidance is provided by the three chapters. In Chapter 1, the role of quality assurance in obtaining quality data and the importance of such data are discussed. Chapter 2 presents the elements of laboratory quality assurance in terms of practices that can be used in controlling work activities to assure the acquisition of quality data. Chapter 3 discusses the implementation of laboratory quality assurance. The appendices provide supplemental information to give the users a better understanding of the following: what is quality assurance; why quality assurance is required; where quality assurance requirements come from; how those requirements are interpreted for application to laboratory operations; how the elements of laboratory quality assurance relate to various laboratory activities; and how a quality assurance program can be developed

  18. The fIXationof nitrogen in urea ammoniated wheat straw by means ...

    African Journals Online (AJOL)

    The fixation of nitrogen in urea ammoniated wheat straw by means of different acids was investigated in two laboratory trials and in a voluntary-intake trial with adult SA Mutton Merino wethers. Results from the laboratory trials showed hydrochloric and sulphuric acid to be superior to phosphoric and acetic acid as fixation ...

  19. CpG plus radiotherapy: a review of preclinical works leading to clinical trial

    Energy Technology Data Exchange (ETDEWEB)

    Mason, Kathy A.; Hunter, Nancy R., E-mail: [Department of Experimental Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX (United States)


    Studies performed three decades ago in our laboratory supported the hypothesis that radiation efficacy may be augmented by bacterial extracts that stimulate non-specific systemic antitumor immune responses. Application to the clinic was halted by unacceptable side effects and toxicities resulting from exposure to whole bacterial pathogens. Later scientific advances demonstrated that DNA isolated from bacteria was immunostimulatory and could be reproduced with synthetic oligodeoxynucleotides (ODNs), thus fueling the transition from bugs to drugs. Unmethylated CpG motifs within bacterial DNA induce activation of Toll-like receptor 9 and subsequently activate antigen-specific cellular immune responses. CpG ODNs have demonstrated favorable toxicity profiles in phase I clinical trials. We showed that this potent immunoadjuvant can be used in combination with radiation therapy to enhance local and systemic responses of several murine tumors. Studies demonstrated that enhanced tumor response is mediated in part by the host immune system. Antitumor efficacy was diminished in immunocompromised mice. Animals cured by combination of radiation and CpG ODN were resistant to subsequent tumor rechallenge. This body of work contributes to our understanding of the dynamic interplay between tumor irradiation and the host immune system and may facilitate translation to clinical trials.

  20. CpG plus radiotherapy: a review of preclinical works leading to clinical trial

    International Nuclear Information System (INIS)

    Mason, Kathy A.; Hunter, Nancy R.


    Studies performed three decades ago in our laboratory supported the hypothesis that radiation efficacy may be augmented by bacterial extracts that stimulate non-specific systemic antitumor immune responses. Application to the clinic was halted by unacceptable side effects and toxicities resulting from exposure to whole bacterial pathogens. Later scientific advances demonstrated that DNA isolated from bacteria was immunostimulatory and could be reproduced with synthetic oligodeoxynucleotides (ODNs), thus fueling the transition from bugs to drugs. Unmethylated CpG motifs within bacterial DNA induce activation of Toll-like receptor 9 and subsequently activate antigen-specific cellular immune responses. CpG ODNs have demonstrated favorable toxicity profiles in phase I clinical trials. We showed that this potent immunoadjuvant can be used in combination with radiation therapy to enhance local and systemic responses of several murine tumors. Studies demonstrated that enhanced tumor response is mediated in part by the host immune system. Antitumor efficacy was diminished in immunocompromised mice. Animals cured by combination of radiation and CpG ODN were resistant to subsequent tumor rechallenge. This body of work contributes to our understanding of the dynamic interplay between tumor irradiation and the host immune system and may facilitate translation to clinical trials.

  1. Evaluation of the analytic performance of laboratories: inter-laboratorial study of the spectroscopy of atomic absorption

    International Nuclear Information System (INIS)

    Wong Wong, S. M.


    The author made an inter-laboratorial study, with the participation of 18 national laboratories, that have spectrophotometer of atomic absorption. To evaluate the methods of analysis of lead, sodium, potasium, calcium, magnesium, zinc, copper, manganese, and iron, in the ambit of mg/l. The samples, distributed in four rounds to the laboratories, were prepared from primary patterns, deionized and distilled water. The study evaluated the homogeneity and stability, and verified its concentration, using as a reference method, the spectrometry method of Inductively Coupled Plasma emission (1CP). To obtain the characteristics of analytic performance, it applied the norm ASTM E 691. To evaluated the analytic performance, it used harmonized protocol of the International Union of Pure and applied chemistry (IUPAC). The study obtained the 29% of the laboratories had a satisfactory analytic performance, 9% had a questionable performance and 62% made an unsatisfactory analytic performance, according to the IUPAC norm. The results of the values of the characteristic performance method, show that there is no intercomparability between the laboratories, which is attributed to the different methodologies of analysis. (S. Grainger)

  2. Variation in the measurement of DNA damage by comet assay measured by the ECVAG dagger inter-laboratory validation trial

    DEFF Research Database (Denmark)

    Forchhammer, Lykke; Johansson, Clara; Loft, Steffen


    the level of DNA damage in monocyte-derived THP-1 cells by either visual classification or computer-aided image analysis of pre-made slides, coded cryopreserved samples of cells and reference standard cells (calibration curve samples). The reference standard samples were irradiated with ionizing radiation...... by the different laboratories as evidenced by an inter-laboratory coefficient of variation (CV) of 47%. Adjustment of the primary comet assay end points by a calibration curve prepared in each laboratory reduced the CV to 28%, a statistically significant reduction (P test). A large fraction...

  3. Draft Strategic Laboratory Missions Plan. Volume II

    International Nuclear Information System (INIS)


    This volume described in detail the Department's research and technology development activities and their funding at the Department's laboratories. It includes 166 Mission Activity Profiles, organized by major mission area, with each representing a discrete budget function called a Budget and Reporting (B ampersand R) Code. The activities profiled here encompass the total research and technology development funding of the laboratories from the Department. Each profile includes a description of the activity and shows how the funding for that activity is distributed among the DOE laboratories as well as universities and industry. The profiles also indicate the principal laboratories for each activity, as well as which other laboratories are involved. The information in this volume is at the core of the Strategic Laboratory Mission Plan. It enables a reader to follow funds from the Department's appropriation to a specific activity description and to specific R ampersand D performing institutions. This information will enable the Department, along with the Laboratory Operations Board and Congress, to review the distribution of R ampersand D performers chosen to execute the Department's missions

  4. Draft Strategic Laboratory Missions Plan. Volume II

    Energy Technology Data Exchange (ETDEWEB)



    This volume described in detail the Department`s research and technology development activities and their funding at the Department`s laboratories. It includes 166 Mission Activity Profiles, organized by major mission area, with each representing a discrete budget function called a Budget and Reporting (B & R) Code. The activities profiled here encompass the total research and technology development funding of the laboratories from the Department. Each profile includes a description of the activity and shows how the funding for that activity is distributed among the DOE laboratories as well as universities and industry. The profiles also indicate the principal laboratories for each activity, as well as which other laboratories are involved. The information in this volume is at the core of the Strategic Laboratory Mission Plan. It enables a reader to follow funds from the Department`s appropriation to a specific activity description and to specific R & D performing institutions. This information will enable the Department, along with the Laboratory Operations Board and Congress, to review the distribution of R & D performers chosen to execute the Department`s missions.

  5. Web-Based Virtual Laboratory for Food Analysis Course (United States)

    Handayani, M. N.; Khoerunnisa, I.; Sugiarti, Y.


    Implementation of learning on food analysis course in Program Study of Agro-industrial Technology Education faced problems. These problems include the availability of space and tools in the laboratory that is not comparable with the number of students also lack of interactive learning tools. On the other hand, the information technology literacy of students is quite high as well the internet network is quite easily accessible on campus. This is a challenge as well as opportunities in the development of learning media that can help optimize learning in the laboratory. This study aims to develop web-based virtual laboratory as one of the alternative learning media in food analysis course. This research is R & D (research and development) which refers to Borg & Gall model. The results showed that assessment’s expert of web-based virtual labs developed, in terms of software engineering aspects; visual communication; material relevance; usefulness and language used, is feasible as learning media. The results of the scaled test and wide-scale test show that students strongly agree with the development of web based virtual laboratory. The response of student to this virtual laboratory was positive. Suggestions from students provided further opportunities for improvement web based virtual laboratory and should be considered for further research.

  6. Noise study in laboratories with exhaust fans

    International Nuclear Information System (INIS)

    Shaikh, G.H.; Hashmi, R.; Shareef, A.


    Noise study has been carried out in 25 laboratories fitted with exhaust fans. We have studied A- Weighted equivalent sound pressure levels (dB(A) LAeJ and equivalent octave band sound pressure levels (dB L/sub eq/ in each of the laboratories surveyed. The data collected has been analyzed for Preferred Speech Interference Levels (PSIL). The results show that the interior noise levels in these laboratories vary from 59.6 to 72.2 dB(A) L/sub Aeq/, which are very high and much beyond the interior noise limits recommended for laboratories. Some ways and means to limit emission of high-level noise from exhaust fans are also discussed. (author)

  7. Can harmonized regulation overcome intra-European differences? Insights from a European Phase III stem cell trial. (United States)

    Hauskeller, Christine


    Harmonized regulation of research with human stem cells in Europe has shaped innovation in regenerative medicine. Findings from a Phase III academic clinical trial of an autologous cell procedure illustrate the obstacles that a multinational trial faces. A typology of the obstacles encountered, may help other teams embarking upon trials. The findings throw light on the situation of clinician-scientists in clinical innovation, as the expertise to run scientific trials is very complex. The innovation route of clinical translation takes insufficient account of the interdependencies between multiple social and cultural factors from outside the laboratory and the clinic. For ethical reasons, however, academic and business routes to stem cell treatments ought to be enabled by the regulators. Suggestions arise, how academics can prepare for trials, that academic research needs better institutional support and that new models of medical innovation may need to be developed for regenerative medicine.

  8. Preliminary findings of a randomized trial of non-pharmaceutical interventions to prevent influenza transmission in households.

    Directory of Open Access Journals (Sweden)

    Benjamin J Cowling


    Full Text Available There are sparse data on whether non-pharmaceutical interventions can reduce the spread of influenza. We implemented a study of the feasibility and efficacy of face masks and hand hygiene to reduce influenza transmission among Hong Kong household members.We conducted a cluster randomized controlled trial of households (composed of at least 3 members where an index subject presented with influenza-like-illness of <48 hours duration. After influenza was confirmed in an index case by the QuickVue Influenza A+B rapid test, the household of the index subject was randomized to 1 control or 2 surgical face masks or 3 hand hygiene. Households were visited within 36 hours, and 3, 6 and 9 days later. Nose and throat swabs were collected from index subjects and all household contacts at each home visit and tested by viral culture. The primary outcome measure was laboratory culture confirmed influenza in a household contact; the secondary outcome was clinically diagnosed influenza (by self-reported symptoms. We randomized 198 households and completed follow up home visits in 128; the index cases in 122 of those households had laboratory-confirmed influenza. There were 21 household contacts with laboratory confirmed influenza corresponding to a secondary attack ratio of 6%. Clinical secondary attack ratios varied from 5% to 18% depending on case definitions. The laboratory-based or clinical secondary attack ratios did not significantly differ across the intervention arms. Adherence to interventions was variable.The secondary attack ratios were lower than anticipated, and lower than reported in other countries, perhaps due to differing patterns of susceptibility, lack of significant antigenic drift in circulating influenza virus strains recently, and/or issues related to the symptomatic recruitment design. Lessons learnt from this pilot have informed changes for the main study in NCT00425893 HKCTR-365.

  9. An analysis of registered clinical trials in otolaryngology from 2007 to 2010: (United States)

    Witsell, David L; Schulz, Kristine A; Lee, Walter T; Chiswell, Karen


    To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. Database analysis. Trial registration data downloaded from and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to for further analysis. Chi-square tests were used to explore differences between groups. A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. Analysis of otolaryngology-related clinical research as listed in can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

  10. Applying decision trial and evaluation laboratory as a decision tool for effective safety management system in aviation transport

    Directory of Open Access Journals (Sweden)

    Ifeanyichukwu Ebubechukwu Onyegiri


    Full Text Available In recent years, in the aviation industry, the weak engineering controls and lapses associated with safety management systems (SMSs are responsible for the seemingly unprecedented disasters. A previous study has confirmed the difficulties experienced by safety managers with SMSs and the need to direct research to this area of investigation for more insights and progress in the evaluation and maintenance of SMSs in the aviation industry. The purpose of this work is to examine the application of Decision Trial and Evaluation Laboratory (DEMATEL to the aviation industry in developing countries with illustration using the Nigerian aviation survey data for the validation of the method. The advantage of the procedure over other decision making methods is in its ability to apply feedback in its decision making. It also affords us the opportunity of breaking down the complex aviation SMS components and elements which are multi-variate in nature through the analysis of the contributions of the diverse system criteria from the perspective of cause and effects, which in turn yields easier and yet more effective aviation transportation accident pre-corrective actions. In this work, six revised components of an SMS were identified and DEMATEL was applied to obtain their direct and indirect impacts and influences on the overall SMS performance. Data collection was by the survey questionnaire, which served as the initial direct-relation matrix, coded in Matlab software for establishing the impact relation map (IRM. The IRM was then plotted in MS Excel spread-sheet software. From our results, safety structure and regulation has the highest impact level on an SMS with a corresponding positive relation level value. In conclusion, the results agree with those of previous researchers that used grey relational analysis. Thus, DEMATEL serves as a great tool and resource for the safety manager.

  11. An inter-laboratory validation of a real time PCR assay to measure host excretion of bacterial pathogens, particularly of Mycobacterium bovis.

    Directory of Open Access Journals (Sweden)

    Emma R Travis

    Full Text Available Advances in the diagnosis of Mycobacterium bovis infection in wildlife hosts may benefit the development of sustainable approaches to the management of bovine tuberculosis in cattle. In the present study, three laboratories from two different countries participated in a validation trial to evaluate the reliability and reproducibility of a real time PCR assay in the detection and quantification of M. bovis from environmental samples. The sample panels consisted of negative badger faeces spiked with a dilution series of M. bovis BCG Pasteur and of field samples of faeces from badgers of unknown infection status taken from badger latrines in areas with high and low incidence of bovine TB (bTB in cattle. Samples were tested with a previously optimised methodology. The experimental design involved rigorous testing which highlighted a number of potential pitfalls in the analysis of environmental samples using real time PCR. Despite minor variation between operators and laboratories, the validation study demonstrated good concordance between the three laboratories: on the spiked panels, the test showed high levels of agreement in terms of positive/negative detection, with high specificity (100% and high sensitivity (97% at levels of 10(5 cells g(-1 and above. Quantitative analysis of the data revealed low variability in recovery of BCG cells between laboratories and operators. On the field samples, the test showed high reproducibility both in terms of positive/negative detection and in the number of cells detected, despite low numbers of samples identified as positive by any laboratory. Use of a parallel PCR inhibition control assay revealed negligible PCR-interfering chemicals co-extracted with the DNA. This is the first example of a multi-laboratory validation of a real time PCR assay for the detection of mycobacteria in environmental samples. Field studies are now required to determine how best to apply the assay for population-level b

  12. Laboratory, Epidemiological, and Human Intervention Studies Show That Tea (Camellia sinensis) May Be Useful in the Prevention of Obesity12


    Grove, Kimberly A.; Lambert, Joshua D.


    Tea (Camellia sinensis, Theaceae) and tea polyphenols have been studied for the prevention of chronic diseases, including obesity. Obesity currently affects >20% of adults in the United States and is a risk factor for chronic diseases such as type II diabetes, cardiovascular disease, and cancer. Given this increasing public health concern, the use of dietary agents for the prevention of obesity would be of tremendous benefit. Whereas many laboratory studies have demonstrated the potential eff...

  13. Studies on fact of 14C-lindane in soil and chickpea plants under laboratory conditions

    International Nuclear Information System (INIS)

    Meguenni, H.


    The degradation of 14 C-lindane (γ-1,2,3,4,5,6 - hexachlorocyclohexane) was investigated under laboratory conditions. Chickpea plants and soil were treated with 14 C-lindane. The results indicated a decrease of lindane on the plant surface from 36.6% to 6.5% and a corresponding increase in extractable residues from within the plant from 12.5% to 34.5% during the 60 days of the trial. In the soil, extractable residues decreased from 47.4% to 31.2%. Bound residues in both plant and soil remained low throughout the trial. After 60 days, the chickpea plants took up 16.4% of the lindane applied to the soil. (author). 2 refs, 7 figs

  14. The IAEA Laboratories at Seibersdorf

    International Nuclear Information System (INIS)


    The film shows the history, development and activities at the IAEA's Laboratory in Seibersdorf. Recent developments in plant breeding and insect pest control (sterile insect technique) and training facilities for fellows from member states are presented

  15. Design of laboratory radiotracer studies in marine radioecology

    International Nuclear Information System (INIS)

    Schulte, E.H.


    A condensed description of methods used in laboratory radiotracer studies in marine radioecology is presented showing also the difficulties which may be encountered in order to obtain realistic and comparable information on the general behaviour of radionuclides in marine organisms. Practical guidance on the choice of the biological material and how to setup laboratory experiments and to control properly important experimental conditions are given. Key parameters like concentration factors and biological half-lives are defined and the theoretical estimation and practical determination of input, uptake, accumulation and loss of radionuclides in marine biota are formulated by the aid of mathematical equations. Examples of uptake and loss curves obtained in the laboratory are shown. The importance of some environmental factors (temperature, food, growth) on uptake and loss of radionuclides are demonstrated. Comparison of experimental and field data of concentration factors is reported to show the difficulty in extrapolating from laboratory experiments to nature. (author)

  16. Teaching Creative Thinking Skills with Laboratory Work

    Directory of Open Access Journals (Sweden)

    Nur Khoiri


    Full Text Available Research on figuring out the ways to teach creative thinking skills via learning processes has been carried out. One of the methods applied to be efficient to teach creative thinking skills is laboratory work. Laboratory work is an important process in learning physics since students tend to find it hard to understand physical concepts if they are only taught verbally. Students will understand better when they are given real life examples and are allowed to learn the concepts through the laboratory work, whenever possible. The research was conducted at SMAN 1 Bringin by employing the quasi-experiment pre-test - post-test control group design. Creative thinking skills were measured based on four indicators: flexibility, fluency, originality, and detail. Results show that laboratory work was suitable to improve students’ fluent thinking ability with 77% students showing improvement, and it was also a fit to improve students’ original thinking with 84% students showing improvement. The experiment class revealed a gain of 0.51, taken from an average pre-test score of 45.64 compared to the average post-test score of 73.5, which is an increase of 27.86. Meanwhile, the control class resulted in a gain of 0.40, taken from an average pre-test score of 39.11 compared to the average post-test score of 83.44, which is an increase of 24.33.

  17. Constructivist Learning Environment During Virtual and Real Laboratory Activities

    Directory of Open Access Journals (Sweden)

    Ari Widodo


    Full Text Available Laboratory activities and constructivism are two notions that have been playing significant roles in science education. Despite common beliefs about the importance of laboratory activities, reviews reported inconsistent results about the effectiveness of laboratory activities. Since laboratory activities can be expensive and take more time, there is an effort to introduce virtual laboratory activities. This study aims at exploring the learning environment created by a virtual laboratory and a real laboratory. A quasi experimental study was conducted at two grade ten classes at a state high school in Bandung, Indonesia. Data were collected using a questionnaire called Constructivist Learning Environment Survey (CLES before and after the laboratory activities. The results show that both types of laboratories can create constructivist learning environments. Each type of laboratory activity, however, may be stronger in improving certain aspects compared to the other. While a virtual laboratory is stronger in improving critical voice and personal relevance, real laboratory activities promote aspects of personal relevance, uncertainty and student negotiation. This study suggests that instead of setting one type of laboratory against the other, lessons and follow up studies should focus on how to combine both types of laboratories to support better learning.

  18. Statin treatment and stroke outcome in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial

    DEFF Research Database (Denmark)

    Goldstein, L.B.; Amarenco, P.; Zivin, J.


    BACKGROUND AND PURPOSE: Laboratory experiments suggest statins reduce stroke severity and improve outcomes. The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial was a placebo-controlled, randomized trial designed to determine whether treatment with atorvastatin reduces...... or 4), moderate (modified Rankin Scale score 3 or 2), and mild (modified Rankin Scale score 1 or 0) outcome ischemic strokes and transient ischemic attacks and an increase in the proportion of event-free subjects randomized to atorvastatin (P

  19. Predictors of smoking lapse in a human laboratory paradigm. (United States)

    Roche, Daniel J O; Bujarski, Spencer; Moallem, Nathasha R; Guzman, Iris; Shapiro, Jenessa R; Ray, Lara A


    During a smoking quit attempt, a single smoking lapse is highly predictive of future relapse. While several risk factors for a smoking lapse have been identified during clinical trials, a laboratory model of lapse was until recently unavailable and, therefore, it is unclear whether these characteristics also convey risk for lapse in a laboratory environment. The primary study goal was to examine whether real-world risk factors of lapse are also predictive of smoking behavior in a laboratory model of smoking lapse. After overnight abstinence, 77 smokers completed the McKee smoking lapse task, in which they were presented with the choice of smoking or delaying in exchange for monetary reinforcement. Primary outcome measures were the latency to initiate smoking behavior and the number of cigarettes smoked during the lapse. Several baseline measures of smoking behavior, mood, and individual traits were examined as predictive factors. Craving to relieve the discomfort of withdrawal, withdrawal severity, and tension level were negatively predictive of latency to smoke. In contrast, average number of cigarettes smoked per day, withdrawal severity, level of nicotine dependence, craving for the positive effects of smoking, and craving to relieve the discomfort of withdrawal were positively predictive of number of cigarettes smoked. The results suggest that real-world risk factors for smoking lapse are also predictive of smoking behavior in a laboratory model of lapse. Future studies using the McKee lapse task should account for between subject differences in the unique factors that independently predict each outcome measure.

  20. Clinical trials attitudes and practices of Latino physicians. (United States)

    Ramirez, Amelie G; Wildes, Kimberly; Talavera, Greg; Nápoles-Springer, Anna; Gallion, Kipling; Pérez-Stable, Eliseo J


    Ethnic differences in physicians' attitudes and behaviors related to clinical trials might partially account for disparities in clinical trial participation among Latino patients. Literature regarding Latino physicians' clinical trials attitudes and practices, in comparison to White physicians, was lacking. Cross-sectional data from randomly selected physicians (N=695), stratified by ethnicity, were analyzed to test associations of ethnicity with physicians' participation in and attitudes toward referral of patients to clinical trials. Chi-square analyses showed significant (pLatino physicians were significantly less involved in clinical trials than White physicians and found less scientific value in them, highlighting areas for future education and intervention.

  1. Smoking cue reactivity across massed extinction trials: negative affect and gender effects. (United States)

    Collins, Bradley N; Nair, Uma S; Komaroff, Eugene


    Designing and implementing cue exposure procedures to treat nicotine dependence remains a challenge. This study tested the hypothesis that gender and negative affect (NA) influence changes in smoking urge over time using data from a pilot project testing the feasibility of massed extinction procedures. Forty-three smokers and ex-smokers completed the behavioral laboratory procedures. All participants were over 17 years old, smoked at least 10 cigarettes daily over the last year (or the year prior to quitting) and had expired CO below 10 ppm at the beginning of the ~4-hour session. After informed consent, participants completed 45 min of baseline assessments, and then completed a series of 12 identical, 5-minute exposure trials with inter-trial breaks. Smoking cues included visual, tactile, and olfactory cues with a lit cigarette, in addition to smoking-related motor behaviors without smoking. After each trial, participants reported urge and negative affect (NA). Logistic growth curve models supported the hypothesis that across trials, participants would demonstrate an initial linear increase followed by a decrease in smoking urge (quadratic effect). Data supported hypothesized gender, NA, and gender×NA effects. Significant linear increases in urge were observed among high and low NA males, but not among females in either NA subgroup. A differential quadratic effect showed a significant decrease in urge for the low NA subgroup, but a non-significant decrease in urge in the high NA group. This is the first study to demonstrate gender differences and the effects of NA on the extinction process using a smoking cue exposure paradigm. Results could guide future cue reactivity research and exposure interventions for nicotine dependence. Copyright © 2010 Elsevier B.V. All rights reserved.

  2. Internal quality control indicators of cervical cytopathology exams performed in laboratories monitored by the External Quality Control Laboratory. (United States)

    Ázara, Cinara Zago Silveira; Manrique, Edna Joana Cláudio; Tavares, Suelene Brito do Nascimento; de Souza, Nadja Lindany Alves; Amaral, Rita Goreti


    To evaluate the impact of continued education provided by an external quality control laboratory on the indicators of internal quality control of cytopathology exams. The internal quality assurance indicators for cytopathology exams from 12 laboratories monitored by the External Quality Control Laboratory were evaluated. Overall, 185,194 exams were included, 98,133 of which referred to the period preceding implementation of a continued education program, while 87,061 referred to the period following this intervention. Data were obtained from the Cervical Cancer Database of the Brazilian National Health Service. Following implementation of the continued education program, the positivity index (PI) remained within recommended limits in four laboratories. In another four laboratories, the PI progressed from below the limits to within the recommended standards. In one laboratory, the PI remained low, in two laboratories, it remained very low, and in one, it increased from very low to low. The percentage of exams compatible with a high-grade squamous intraepithelial lesion (HSIL) remained within the recommended limits in five laboratories, while in three laboratories it progressed from below the recommended levels to >0.4% of the total number of satisfactory exams, and in four laboratories it remained below the standard limit. Both the percentage of atypical squamous cells of undetermined significance (ASC-US) in relation to abnormal exams, and the ratio between ASC-US and intraepithelial lesions remained within recommended levels in all the laboratories investigated. An improvement was found in the indicators represented by the positivity index and the percentage of exams compatible with a high-grade squamous intraepithelial lesion, showing that the role played by the external quality control laboratory in providing continued education contributed towards improving laboratory staff skills in detecting cervical cancer precursor lesions.

  3. Powder metallurgy at Savannah River Laboratory

    International Nuclear Information System (INIS)

    Peacock, H.B.


    Development of a powder metallurgical process for the manufacture of reactor grade fuel tubes is being carried out at the Savannah River Laboratory (SRL). Using the P/M technology, cores were isostatically compacted with 100 wt % U 3 O 8 and coextruded tubes fabricated which contain up to approx. 80% cores clad with aluminum. Irradiation tests were completed for tubes with up to 59 wt % oxide. Post-irradiation inspection showed no significant swelling for 40% burnup. Thermal testing of sections from irradiated tubes showed that the threshold temperature for blister formation increased as the fission density of oxide decreased. Procedures are discussed for making PM cores and extruded tubes at SRL. Both laboratory and full-scale tests are presented

  4. 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


    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

  5. Bioassay Laboratory (United States)

    Federal Laboratory Consortium — The Bioassay Laboratory is an accredited laboratory capable of conducting standardized and innovative environmental testing in the area of aquatic ecotoxicology. The...


    Federal Laboratory Consortium — Naval Academy Hydromechanics LaboratoryThe Naval Academy Hydromechanics Laboratory (NAHL) began operations in Rickover Hall in September 1976. The primary purpose of...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... research process. The process often begins in a laboratory (lab), where scientists first develop and test new ideas. If an approach seems promising, the next step may involve animal testing. This shows how the approach affects a ...

  8. ELISA testing for soy antigens in dry dog foods used in dietary elimination trials. (United States)

    Willis-Mahn, Christine; Remillard, Rebecca; Tater, Kathy


    The use of elimination diet trials is necessary in the diagnosis of food allergies and intolerances. The objective of this study was to determine in vitro if four over-the-counter (OTC) dry dog foods carrying a "no soy" claim and seven veterinary therapeutic dry dog foods designed for food elimination trials were suitable for a soybean elimination trial. A 100 g sample of each diet plus one soy positive and one soy negative control diet were submitted for enzyme-linked immunosorbent assay testing to an independent food laboratory. The positive control diet contained >25 ppm soy protein antigens and the negative control contained 25 ppm. Three veterinary therapeutic diets had less than the lowest detectable limit of soy protein and four were positive (>2.5 ppm). OTC dog food diets that claim to contain "no soy" may contain high concentrations of soy protein and, therefore, should not be used in soy elimination trials in suspect food allergic dogs. The veterinary therapeutic diet selected for a soy elimination trial needs to be carefully chosen based on diet history.

  9. Remote monitoring field trial. Application to automated air sampling. Report on Task FIN-E935 of the Finnish Support Programme to IAEA Safeguards

    International Nuclear Information System (INIS)

    Poellaenen, R.; Ilander, T.; Lehtinen, J.; Leppaenen, A.; Nikkinen, M.; Toivonen, H.; Ylaetalo, S.; Smartt, H.; Garcia, R.; Martinez, R.; Glidewell, D.; Krantz, K.


    An automated air sampling station has recently been developed by Radiation and Nuclear Safety Authority (STUK). The station is furnished with equipment that allows comprehensive remote monitoring of the station and the data. Under the Finnish Support Programme to IAEA Safeguards, STUK and Sandia National Laboratories (SNL) established a field trial to demonstrate the use of remote monitoring technologies. STUK provided means for real-lime radiation monitoring and sample authentication whereas SNL delivered means for authenticated surveillance of the equipment and its location. The field trial showed that remote monitoring can be carried out using simple means although advanced facilities are needed for comprehensive surveillance. Authenticated measurement data could be reliably transferred from the monitoring site to the headquarters without the presence of authorized personnel in the monitoring site. The operation of the station and the remote monitoring system were reliable. (orig.)

  10. Influence of experimental esophageal acidification on sleep bruxism: a randomized trial. (United States)

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


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

  11. The effect of extrinsic motivation on cycle time trial performance. (United States)

    Hulleman, Michiel; De Koning, Jos J; Hettinga, Florentina J; Foster, Carl


    Athletes occasionally follow pacing patterns that seem unreasonably aggressive compared with those of prerace performances, potentially because of the motivation provided by competition. This study evaluated the effect of extrinsic motivation on cyclists' time trial performance. Well-trained recreational cyclists (N=7) completed four 1500-m laboratory time trials including a practice trial, two self-paced trials, and a trial where a monetary reward was offered. Time, total power output, power output attributable to aerobic and anaerobic metabolic sources, VO2, and HR were measured. The time required for the second, third, and last (extrinsically motivated) time trials was 133.1 +/- 2.1, 134.1 +/- 3.4, and 133.6 +/- 3.0 s, respectively, and was not different (P>0.05). There were no differences for total (396 +/- 19, 397 +/- 23, and 401 +/- 17 W), aerobic (253 +/- 12, 254 +/- 10, and 246 +/- 13 W), and anaerobic (143 +/- 14, 143 +/- 21, and 155 +/- 11 W) power output. The highest VO2 was not different over consecutive time trials (3.76 +/- 0.19, 3.73 +/- 0.16, and 3.71 +/- 0.22 L x min(-1)). When ranked by performance, without reference to the extrinsic motivation (131.9 +/- 2.4, 133.4 +/- 2.4, and 135.4 +/- 2.5 s), there was a significant difference for the first 100 m and from 100 to 300 m in power output, with a larger total power (560 +/- 102, 491 +/- 82, and 493 +/- 93; and 571 +/- 94, 513 +/- 41, and 484 +/- 88 W) and power attributable to anaerobic sources (446 +/- 100, 384 +/- 80, and 324 +/- 43; and 381 +/- 87, 383 +/- 90, and 289 +/- 91 W) for the fastest trial. Extrinsic motivation did not change the time trial performance, suggesting that 1500-m performance is extremely stable and not readily changeable with simple external motivation. The results suggest that spontaneous improvement in performance for time trials of this duration is attributable to greater early power output, which is primarily attributable to anaerobic metabolic sources.

  12. A multilayer biomaterial for osteochondral regeneration shows superiority vs microfractures for the treatment of osteochondral lesions in a multicentre randomized trial at 2 years. (United States)

    Kon, Elizaveta; Filardo, Giuseppe; Brittberg, Mats; Busacca, Maurizio; Condello, Vincenzo; Engebretsen, Lars; Marlovits, Stefan; Niemeyer, Philipp; Platzer, Patrik; Posthumus, Michael; Verdonk, Peter; Verdonk, Renè; Victor, Jan; van der Merwe, Willem; Widuchowski, Wojciech; Zorzi, Claudio; Marcacci, Maurilio


    The increasing awareness on the role of subchondral bone in the etiopathology of articular surface lesions led to the development of osteochondral scaffolds. While safety and promising results have been suggested, there are no trials proving the real potential of the osteochondral regenerative approach. Aim was to assess the benefit provided by a nanostructured collagen-hydroxyapatite (coll-HA) multilayer scaffold for the treatment of chondral and osteochondral knee lesions. In this multicentre randomized controlled clinical trial, 100 patients affected by symptomatic chondral and osteochondral lesions were treated and evaluated for up to 2 years (51 study group and 49 control group). A biomimetic coll-HA scaffold was studied, and bone marrow stimulation (BMS) was used as reference intervention. Primary efficacy measurement was IKDC subjective score at 2 years. Secondary efficacy measurements were: KOOS, IKDC Knee Examination Form, Tegner and VAS Pain scores evaluated at 6, 12 and 24 months. Tissue regeneration was evaluated with MRI MOCART scoring system at 6, 12 and 24 months. An external independent agency was involved to ensure data correctness and objectiveness. A statistically significant improvement of all clinical scores was obtained from basal evaluation to 2-year follow-up in both groups, although no overall statistically significant differences were detected between the two treatments. Conversely, the subgroup of patients affected by deep osteochondral lesions (i.e. Outerbridge grade IV and OCD) showed a statistically significant better IKDC subjective outcome (+12.4 points, p = 0.036) in the coll-HA group. Statistically significant better results were also found for another challenging group: sport active patients (+16.0, p = 0.027). Severe adverse events related to treatment were documented only in three patients in the coll-HA group and in one in the BMS group. The MOCART score showed no statistical difference between the two groups. This

  13. Isotretinoin therapy: Any need for laboratory assessment? | Tallab ...

    African Journals Online (AJOL)

    Background: Recently studies showed the no need for laboratory follow up of patients on isotretinoin therapy. The aim of this study is to assess this issue. Patients and methods: A retrospective study on 400 patients was performed to analyze the laboratory data before and after isotretinoin therapy of acne vulgaris patients.

  14. Clinical Trials

    Medline Plus

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

  15. Laboratory operation during radiation emergency

    International Nuclear Information System (INIS)

    Bunata, M.; Prouza, Z.; Tecl, J.


    During radiation emergency, a special operation mode of laboratories of the Radiation Monitoring Network (hereinafter RMN) is expected. The principal factors differing the emergency mode from the normal one are the following: - significantly higher amount of analyzed samples; - high activities of the majority of the samples; - higher risk of personal and equipment contamination; - higher working and psychological demands on laboratory staff. The assuring of the radiation protection requirements of laboratory staff has to be the primary objective, nevertheless the risk of equipment contamination and of samples cross- contamination of course have to be as well taken into consideration. The presentation describes the experience of the RMN Central Laboratory of the National Radiation Protection Institute in Prague (SURO) which was obtained during realization of field tests, in which a radioactive matter was released. These tests allow us to evaluate the source term or radioactivity dispersal balance based on various detection methods with the aim to estimate exposure of the afflicted persons. Tests provided to simulate emergency working conditions in Central Laboratory - high number of contaminated samples, which have to be analyzed in a short time (short half-time of used radionuclide 99m Tc) using sophisticated laboratory techniques (gamma spectrometers, aerosols collectors, etc.). The testing shows the availability of the SURO laboratory to work during the radiation emergency and to participate on its determination. The suitable settings and the ideal number of staff have been found. The average analysis time was approximately 1 minute per sample and the sample results were available just a few minutes after the counting. Moreover, the settings avoided any danger and kept both the crew and the samples safe and secure from contamination. (authors)

  16. Laboratory operation during radiation emergency

    International Nuclear Information System (INIS)

    Bunata, M.; Tecl, J.; Prouza, Z.


    During radiation emergency, a special operation mode of laboratories of the Radiation Monitoring Network (hereinafter RMN) is expected. The principal factors differing the emergency mode from the normal one are the following: - significantly higher amount of analyzed samples; - high activities of the majority of the samples; - higher risk of personal and equipment contamination; - higher working and psychological demands on laboratory staff. The assuring of the radiation protection requirements of laboratory staff has to be the primary objective, nevertheless the risk of equipment contamination and of samples cross- contamination of course have to be as well taken into consideration. The presentation describes the experience of the RMN Central Laboratory of the National Radiation Protection Institute in Prague (SURO) which was obtained during realization of field tests, in which a radioactive matter was released. These tests allow us to evaluate the source term or radioactivity dispersal balance based on various detection methods with the aim to estimate exposure of the afflicted persons. Tests provided to simulate emergency working conditions in Central Laboratory -high number of contaminated samples, which have to be analyzed in a short time (short half-time of used radionuclide 99m Tc) using sophisticated laboratory techniques (gamma spectrometers, aerosols collectors, etc.). The testing shows the availability of the SURO laboratory to work during the radiation emergency and to participate on its determination. The suitable settings and the ideal number of staff have been found. The average analysis time was approximately 1 minute per sample and the sample results were available just a few minutes after the counting. Moreover, the settings avoided any danger and kept both the crew and the samples safe and secure from contamination. (authors)

  17. Large Cancer Drug Trial Helps Move Precision Medicine Toward the Mainstream | Frederick National Laboratory for Cancer Research (United States)

    A landmark cancer drug trial is helping set the stage for moving precision medicine into the mainstream of clinical practice, according to a new study. The study, reported in the Journal of Molecular Diagnostics, validates a procedure used in the dru

  18. Effect of Simulation on the Confidence of University Nursing Students in Applying Cardiopulmonary Assessment Skills: A Randomized Controlled Trial. (United States)

    Tawalbeh, Loai I


    Simulation is an effective teaching strategy. However, no study in Jordan has examined the effect of simulation on the confidence of university nursing students in applying heart and lung physical examination skills. The current study aimed to test the effect of simulation on the confidence of university nursing students in applying heart and lung physical examination skills. A randomized controlled trial design was applied. The researcher introduced the simulation scenario regarding cardiopulmonary examination skills. This scenario included a 1-hour PowerPoint presentation and video for the experimental group (n= 35) and a PowerPoint presentation and a video showing a traditional demonstration in the laboratory for the control group (n = 34). Confidence in applying cardiopulmonary physical examination skills was measured for both groups at baseline and at 1 day and 3 months posttest. A paired t test showed that confidence was significantly higher in the posttest than in the pretest for both groups. An independent t test showed a statistically significant difference (t(67) = -42.95, p skills. Both simulation and traditional training in the laboratory significantly improved the confidence of participants in applying cardiopulmonary assessment skills. However, the simulation training had a more significant effect than usual training in enhancing the confidence of nursing students in applying physical examination skills.

  19. Quality Assurance for Clinical Trials (United States)

    Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.


    Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

  20. Laboratory quality assurance

    International Nuclear Information System (INIS)

    Delvin, W.L.


    The elements (principles) of quality assurance can be applied to the operation of the analytical chemistry laboratory to provide an effective tool for indicating the competence of the laboratory and for helping to upgrade competence if necessary. When used, those elements establish the planned and systematic actions necessary to provide adequate confidence in each analytical result reported by the laboratory (the definition of laboratory quality assurance). The elements, as used at the Hanford Engineering Development Laboratory (HEDL), are discussed and they are qualification of analysts, written methods, sample receiving and storage, quality control, audit, and documentation. To establish a laboratory quality assurance program, a laboratory QA program plan is prepared to specify how the elements are to be implemented into laboratory operation. Benefits that can be obtained from using laboratory quality assurance are given. Experience at HEDL has shown that laboratory quality assurance is not a burden, but it is a useful and valuable tool for the analytical chemistry laboratory

  1. A Step Forward in Molecular Diagnostics of Lyssaviruses – Results of a Ring Trial among European Laboratories

    NARCIS (Netherlands)

    Fischer, M.; Wernike, K.; Freuling, C.M.; Müller, T.; Aylan, O.; Brochier, B.; Cliquet, F.; Vázquez-Morón, S.; Hostnik, P.; Huovilainen, A.; Isaksson, M.; Kooi, E.A.


    Rabies is a lethal and notifiable zoonotic disease for which diagnostics have to meet the highest standards. In recent years, an evolution was especially seen in molecular diagnostics with a wide variety of different detection methods published. Therefore, a first international ring trial

  2. Evaluating laboratory key performance using quality indicators in Alexandria University Hospital Clinical Chemistry Laboratories. (United States)

    Rizk, Mostafa M; Zaki, Adel; Hossam, Nermine; Aboul-Ela, Yasmin


    The performance of clinical laboratories plays a fundamental role in the quality and effectiveness of healthcare. To evaluate the laboratory performance in Alexandria University Hospital Clinical Laboratories using key quality indicators and to compare the performance before and after an improvement plan based on ISO 15189 standards. The study was carried out on inpatient samples for a period of 7 months that was divided into three phases: phase I included data collection for evaluation of the existing process before improvement (March-May 2012); an intermediate phase, which included corrective, preventive action, quality initiative and steps for improvement (June 2012); and phase II, which included data collection for evaluation of the process after improvement (July 2012-September 2012). In terms of the preanalytical indicators, incomplete request forms in phase I showed that the total number of received requests were 31 944, with a percentage of defected request of 33.66%; whereas in phase II, there was a significant reduction in all defected request items (Plaboratories.

  3. On the Viability of Supporting Institutional Sharing of Remote Laboratory Facilities (United States)

    Lowe, David; Dang, Bridgette; Daniel, Keith; Murray, Stephen; Lindsay, Euan


    Laboratories are generally regarded as critical to engineering education, and yet educational institutions face significant challenges in developing and maintaining high-quality laboratory facilities. Remote laboratories are increasingly being explored as a partial solution to this challenge, with research showing that--for the right learning…

  4. An Overview of Trials´Accreditation and Recognition of Brazilian Tests Used for the Safety Evaluation of Cosmetic Products

    Directory of Open Access Journals (Sweden)

    Luciana dos Santos Almeida


    Full Text Available For some time, Brazil has been appointed as one of the greatest consumers of cosmetic products in the world. Although cosmetics may seem harmless, destined exclusively to enhance personal appearance or to clean and protect the skin, hair and nails, new studies and events are highlighting the need to evaluate the safety of such products. The present work interrelated the lifecycle of a cosmetic product with the safety trials and tests applicable to some cycle phases. From this information, a survey was made of accredited Conformity Assessment Bodies (CAB and test facilities recognized by the General Coordination for Accreditation (CGCRE which are competent respectively to carry out safety trials and tests of cosmetics. Twenty five competent laboratories were identified to carry out chemical and/or biological trials of cosmetics, according to the legislation ABNT ISO IEC 17025:2005, and 10 test facilities recognized by the Compliance Monitoring Program that can carry out tests of the development of a product for register purposes, aiming at human health and safety. It is interesting to notice that Brazil has accredited laboratories to carry out trials that are critical for the health of the population, such as the levels of heavy metals and the presence of pathogens. On the other hand, CGCRE does not have a program to recognize safety clinical trials. The importance of this kind of study is understood, considering the world history of adverse reactions and the great consumption of cosmetics in the country.

  5. Clinical Trials

    Medline Plus

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

  6. R&W Club Frederick Hosts Second Annual Car Show | Poster (United States)

    A 1994 Ford Thunderbird, a 2006 Porsche 911-S, and a 1996 Chevy Camaro Z28 were just a few of the rides on display this summer at R&W Club Frederick’s second annual Car and Motorcycle Show. “It’s a chance to raise money for a good cause,” said Geoff Seidel, one of the organizers of the event and program director for the Coordinating Center for Clinical Trials, NCI Office of

  7. Online Adaptation and Over-Trial Learning in Macaque Visuomotor Control (United States)

    Braun, Daniel A.; Aertsen, Ad; Paz, Rony; Vaadia, Eilon; Rotter, Stefan; Mehring, Carsten


    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

  8. Safety and health practice among laboratory staff in Malaysian education sector (United States)

    Husna Che Hassan, Nurul; Rasdan Ismail, Ahmad; Kamilah Makhtar, Nor; Azwadi Sulaiman, Muhammad; Syuhadah Subki, Noor; Adilah Hamzah, Noor


    Safety is the most important issue in industrial sector such as construction and manufacturing. Recently, the increasing number of accident cases reported involving school environment shows the important of safety issues in education sector. Safety awareness among staff in this sector is crucial in order to find out the method to prevent the accident occurred in future. This study was conducted to analyze the knowledge of laboratory staff in term of safety and health practice in laboratory. Survey questionnaires were distributing among 255 of staff laboratory from ten District Education Offices in Kelantan. Descriptive analysis shows that the understanding of safety and health practice are low while doing some job activities in laboratory. Furthermore, some of the staff also did not implemented safety practice that may contribute to unplanned event occur in laboratory. Suggestion that the staff at laboratory need to undergo on Occupational Safety and Health training to maintain and create safe environment in workplaces.

  9. Biocarbon urinary conduit: laboratory experience and clinical applications. (United States)

    Kobashi, L I; Raible, D A


    A new urinary conduit utilizing pure vitreous carbon has been used successfully in dogs. Pure carbon appears to be inert with respect to urine and urothelium. Lack of urinary salt encrustation on the exposed surface provides a well-functioning urinary conduit for vesical drainage. Twenty-one vesicostomies were performed in dogs. Careful follow-up and histologic studies of removed specimens were done to establish the biocompatibility of pure carbon. All vesicostomies functioned well. A description of the device, protocol, and results of laboratory experimentation are outlined. The surgical procedure is explained in detail. Results encourage the clinical trial of these devices in humans. Indications include patients with neurogenic vesicla dysfunction and those with total urinary incontinence, both of which require permanent indwelling catheters.

  10. A trial of direct control of pine engraver beetles on a small logging unit (United States)

    W. L. Jackson


    Laboratory tests and small-scale field trials have shown the insecticide lindane to be highly toxic to pine engraver beetles. On the basis of that information, the insecticide was applied to fresh logging slash heavily infested with pine engraver beetles at Challenge Experimental Forest in 1959. Costs were reasonable and no insurmountable problems were encountered....

  11. Heterogeneity of Clinical Trials for Antihypertensive Drugs in Japan: Exploratory Analysis of Confirmatory Phase III Trials Used for Marketing Approval. (United States)

    Kaneko, Reina; Sano, Kota; Ono, Shunsuke


    The results of pivotal trials, which provide a rationale for marketing approval decisions for new drugs, are considered for various comparative purposes in postmarketing analyses. Using meta-regression analysis of 91 randomized controlled trials of 61 approved antihypertensive drugs in Japan, we show that mean baseline blood pressure (BP) of each arm was associated with predetermined entry criteria (EC), age, and trial start year (TSY). BP changes following treatment were associated with EC, subject characteristics (e.g., age, complications, baseline BP), study design (e.g., concomitant drug use), and TSY. Effect sizes were generally larger in trials for the first and second drugs in the same class than in trials for follow-on drugs. Results of pivotal trials may vary depending on many factors, suggesting possible challenges associated with the comparison of these results indirectly. Due to the heterogeneity in pivotal trials, caution should be exercised when comparing approved drugs and conducting meta-analyses retrospectively. © 2017, The American Society for Clinical Pharmacology and Therapeutics.

  12. 75 FR 80011 - Good Laboratory Practice for Nonclinical Laboratory Studies (United States)


    .... FDA-2010-N-0548] Good Laboratory Practice for Nonclinical Laboratory Studies AGENCY: Food and Drug... (FDA) is seeking comment on whether to amend the regulations governing good laboratory practices (GLPs..., 1978 (43 FR 60013). As stated in its scope (Sec. 58.1), this regulation prescribes good laboratory...

  13. Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial.

    LENUS (Irish Health Repository)

    Nichol, Alistair


    Traumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis.

  14. Trial-to-trial dynamics of selective long-term-memory retrieval with continuously changing retrieval targets. (United States)

    Kizilirmak, Jasmin M; Rösler, Frank; Khader, Patrick H


    How do we control the successive retrieval of behaviorally relevant information from long-term memory (LTM) without being distracted by other potential retrieval targets associated to the same retrieval cues? Here, we approach this question by investigating the nature of trial-by-trial dynamics of selective LTM retrieval, i.e., in how far retrieval in one trial has detrimental or facilitatory effects on selective retrieval in the following trial. Participants first learned associations between retrieval cues and targets, with one cue always being linked to three targets, forming small associative networks. In successive trials, participants had to access either the same or a different target belonging to either the same or a different cue. We found that retrieval times were faster for targets that had already been relevant in the previous trial, with this facilitatory effect being substantially weaker when the associative network changed in which the targets were embedded. Moreover, staying within the same network still had a facilitatory effect even if the target changed, which became evident in a relatively higher memory performance in comparison to a network change. Furthermore, event-related brain potentials (ERPs) showed topographically and temporally dissociable correlates of these effects, suggesting that they result from combined influences of distinct processes that aid memory retrieval when relevant and irrelevant targets change their status from trial to trial. Taken together, the present study provides insight into the different processing stages of memory retrieval when fast switches between retrieval targets are required. Copyright © 2014 Elsevier Inc. All rights reserved.

  15. The irradiation as alternative treatment for laboratory wastes

    International Nuclear Information System (INIS)

    Borrely, Sueli Ivone; Romanelli, Maria Fernanda; Silva, Giovana Pasqualini da; Castro, Daniela Marques


    The irradiation of effluents may be done by electron accelerator or gamma radiation source (cobalt-60). This technology has been developed as an alternative for several contaminants from different processes and sources. This paper shows the results of electron beam applied to liquid laboratories residues (effluents and standard solutions). Radiation doses were determined for the improvement of laboratories residues measured by detoxification of them. New technologies for residues treatment as well as decreasing contaminants generation is essential part of laboratories activities for environmental management for industry, universities and research institutions. (author)

  16. Laboratory-acquired brucellosis

    DEFF Research Database (Denmark)

    Fabiansen, C.; Knudsen, J.D.; Lebech, A.M.


    Brucellosis is a rare disease in Denmark. We describe one case of laboratory-acquired brucellosis from an index patient to a laboratory technician following exposure to an infected blood culture in a clinical microbiology laboratory Udgivelsesdato: 2008/6/9......Brucellosis is a rare disease in Denmark. We describe one case of laboratory-acquired brucellosis from an index patient to a laboratory technician following exposure to an infected blood culture in a clinical microbiology laboratory Udgivelsesdato: 2008/6/9...

  17. Novel precooling strategy enhances time trial cycling in the heat. (United States)

    Ross, Megan L R; Garvican, Laura A; Jeacocke, Nikki A; Laursen, Paul B; Abbiss, Chris R; Martin, David T; Burke, Louise M


    To develop and investigate the efficacy of a new precooling strategy combining external and internal techniques on the performance of a cycling time trial (TT) in a hot and humid environment. Eleven well-trained male cyclists undertook three trials of a laboratory-based cycling TT simulating the course characteristics of the Beijing Olympic Games event in a controlled hot and humid environment (32°C-35°C at 50%-60% relative humidity). The trials, separated by 3-7 d, were undertaken in a randomized crossover design and consisted of the following: 1) CON-no treatment apart from the ad libitum consumption of cold water (4°C), 2) STD COOL-whole-body immersion in cold (10°C) water for 10 min followed by wearing a cooling jacket, or 3) NEW COOL-combination of consumption of 14 g of ice slurry ("slushie") per kilogram body mass made from a commercial sports drink while applying iced towels. There was an observable effect on rectal temperature (T(rec)) before the commencement of the TT after both precooling techniques (STD COOL < NEW COOL < CON, P < 0.05), but pacing of the TT resulted in similar T(rec), HR, and RPE throughout the cycling protocol in all trials. NEW COOL was associated with a 3.0% increase in power (approximately 8 W) and a 1.3% improvement in performance time (approximately 1:06 min) compared with the CON trial, with the true likely effects ranging from a trivial to a large benefit. The effect of the STD COOL trial compared with the CON trial was "unclear." This new precooling strategy represents a practical and effective technique that could be used by athletes in preparation for endurance events undertaken in hot and humid conditions.

  18. Perceived barriers in accessing dental care among patients attending dental institute using decision-making trial and evaluation laboratory method

    Directory of Open Access Journals (Sweden)

    Ravneet Malhi


    Full Text Available Introduction: Utilization of dental service is a concept of expressing the extent of interaction between the service provider and the people for whom it is indented. However, one of the major issues in social welfare is the equitable provision of these services to the population. Aim: To determine the perceived barriers affecting access to the dental services in the dental institute. Materials and Methods: A cross-sectional survey was conducted in the dental institute during the month of February in the year 2014 using decision-making trial and evaluation laboratory (DEMATEL method. The study sample included the 364 subjects. The required data were collected using a specially designed and pretested questionnaire. The data were analyzed using SPSS 18.0 (SPSS Inc., Chicago, IL, USA and MATLAB 7.6.0. The mean, standard deviations were used to describe the data, and inferential statistics included one-way ANOVA and DEMATEL. Results: The five determinants of cost, inconvenience, fear, organization, and patient-dentist relationship were determined as barriers to access dental services. Based on subjects′ responses to the questions, the cost (54.75% agreed or strongly agreed was identified as the most important factor affecting the access to dental health care followed by dentist-patient relationship (48.57%, inconvenience (36.55%, fear (23.70%, and organization (14.02%. The difference was found to be statistically significant (P = 0.0001. When the hierarchy of the affecting and affected factors was calculated, based on the factor analysis by using DEMATEL method, the cost (R−J = 0.16 and organization (R−J = 1.15, were certain affecting determinant which influenced the access to dental services and inconvenience. Conclusion: The major barriers to oral health care utilization among our patients were cost, fear, and organization. Policymakers, administrators, and insurance organizations have a major role. Hence, the policies should be fair and

  19. Inter operability of smart field devices on an open field-bus: from laboratory tests to on-site applications

    International Nuclear Information System (INIS)

    Piguet, M.; Favennec, J.M.


    The paper presents a field trial held in EDF's R and D laboratories concerning smart field instruments (sensors, I/O modules, transmitters) operating on the WorldFIP field-bus. The trial put into operation a supervisory control and data acquisition (SCADA) system on the field-bus with available industrial field devices and software tools. The field trial enables EDF's teams to address the inter-operability issue regarding smart field devices and to prepare the forthcoming step from analog to fully digital measurement technology by evaluating new services and higher performances provided. Possible architectures for process control and on-site testing purposes have been identified. A first application for a flow-measuring rig is under way. It implements a WorldFIP field-bus based DCS with FIP/HART multiplexers, FIP and HART smart devices (sensors and actuators) and a field management system. (authors)

  20. Taking Science Online: Evaluating Presence and Immersion through a Laboratory Experience in a Virtual Learning Environment for Entomology Students (United States)

    Annetta, Leonard; Klesath, Marta; Meyer, John


    A 3-D virtual field trip was integrated into an online college entomology course and developed as a trial for the possible incorporation of future virtual environments to supplement online higher education laboratories. This article provides an explanation of the rationale behind creating the virtual experience, the Bug Farm; the method and…

  1. Errors in clinical laboratories or errors in laboratory medicine? (United States)

    Plebani, Mario


    Laboratory testing is a highly complex process and, although laboratory services are relatively safe, they are not as safe as they could or should be. Clinical laboratories have long focused their attention on quality control methods and quality assessment programs dealing with analytical aspects of testing. However, a growing body of evidence accumulated in recent decades demonstrates that quality in clinical laboratories cannot be assured by merely focusing on purely analytical aspects. The more recent surveys on errors in laboratory medicine conclude that in the delivery of laboratory testing, mistakes occur more frequently before (pre-analytical) and after (post-analytical) the test has been performed. Most errors are due to pre-analytical factors (46-68.2% of total errors), while a high error rate (18.5-47% of total errors) has also been found in the post-analytical phase. Errors due to analytical problems have been significantly reduced over time, but there is evidence that, particularly for immunoassays, interference may have a serious impact on patients. A description of the most frequent and risky pre-, intra- and post-analytical errors and advice on practical steps for measuring and reducing the risk of errors is therefore given in the present paper. Many mistakes in the Total Testing Process are called "laboratory errors", although these may be due to poor communication, action taken by others involved in the testing process (e.g., physicians, nurses and phlebotomists), or poorly designed processes, all of which are beyond the laboratory's control. Likewise, there is evidence that laboratory information is only partially utilized. A recent document from the International Organization for Standardization (ISO) recommends a new, broader definition of the term "laboratory error" and a classification of errors according to different criteria. In a modern approach to total quality, centered on patients' needs and satisfaction, the risk of errors and mistakes

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

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


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

  3. Central endoscopy reads in inflammatory bowel disease clinical trials: The role of the imaging core lab. (United States)

    Ahmad, Harris; Berzin, Tyler M; Yu, Hui Jing; Huang, Christopher S; Mishkin, Daniel S


    Clinical trials in inflammatory bowel disease (IBD) are evolving at a rapid pace by employing central reading for endoscopic mucosal assessment in a field that was, historically, largely based on assessments by local physicians. This transition from local to central reading carries with it numerous technical, operational, and scientific challenges, many of which can be resolved by imaging core laboratories (ICLs), a concept that has a longer history in clinical trials in a number of diseases outside the realm of gastroenterology. For IBD trials, ICLs have the dual goals of providing objective, consistent assessments of endoscopic findings using central-reading paradigms whilst providing important expertise with regard to operational issues and regulatory expectations. This review focuses on current approaches to using ICLs for central endoscopic reading in IBD trials. © The Author(s) 2014. Published by Oxford University Press and the Digestive Science Publishing Co. Limited.

  4. Identification of the students' critical thinking skills through biochemistry laboratory work report (United States)

    Anwar, Yunita Arian Sani; Senam, Laksono, Endang W.


    This work aims to (1) identify the critical thinking skills of student based on their ability to set up laboratory work reports, and (2) analyze the implementation of biochemistry laboratory work. The method of quantitative content analysis was employed. Quantitative data were in the form of critical thinking skills through the assessment of students' laboratory work reports and questionnaire data. Hoyo rubric was used to measure critical thinking skills with 10 indicators, namely clarity, accuracy, precision, consistency, relevance, evidence, reason, depth, breadth, and fairness. The research sample consisted of 105 students (35 male, 70 female) of Mataram University who took a Biochemistry course and 2 lecturers of Biochemistry course. The results showed students' critical thinking skills through laboratory work reports were still weak. Analysis of the questionnaire showed that three indicators become the biggest problems during the laboratory work implementation, namely, lecturers' involved in laboratory work implementation, the integration of laboratory work implementation of learning in the classroom has not been done optimally and laboratory work implementation as an effort to train critical thinking skills is not optimal yet.

  5. Spine device clinical trials: design and sponsorship. (United States)

    Cher, Daniel J; Capobianco, Robyn A


    Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (pdevices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. Extra-analytical quality indicators and laboratory performances. (United States)

    Sciacovelli, Laura; Aita, Ada; Plebani, Mario


    In the last few years much progress has been made in raising the awareness of laboratory medicine professionals about the effectiveness of quality indicators (QIs) in monitoring, and improving upon, performances in the extra-analytical phases of the Total Testing Process (TTP). An effective system for management of QIs includes the implementation of an internal assessment system and participation in inter-laboratory comparison. A well-designed internal assessment system allows the identification of critical activities and their systematic monitoring. Active participation in inter-laboratory comparison provides information on the performance level of one laboratory with respect to that of other participating laboratories. In order to guarantee the use of appropriate QIs and facilitate their implementation, many laboratories have adopted the Model of Quality Indicators (MQI) proposed by Working Group "Laboratory Errors and Patient Safety" (WG-LEPS) of IFCC, since 2008, which is the result of international consensus and continuous experimentation, and updating to meet new, constantly emerging needs. Data from participating laboratories are collected monthly and reports describing the statistical results and evaluating laboratory data, utilizing the Six Sigma metric, issued regularly. Although the results demonstrate that the processes need to be improved upon, overall the comparison with data collected in 2014 shows a general stability of quality levels and that an improvement has been achieved over time for some activities. The continuous monitoring of QI data allows identification all possible improvements, thus highlighting the value of participation in the inter-laboratory program proposed by WG-LEPS. The active participation of numerous laboratories will guarantee an ever more significant State-of-the-Art, promote the reduction of errors and improve quality of the TTP, thus guaranteeing patient safety. Copyright © 2017. Published by Elsevier Inc.

  7. Center-Within-Trial Versus Trial-Level Evaluation of Surrogate Endpoints (United States)

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


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

  8. New trial evaluates investigational drug for endometrial and breast cancers | Center for Cancer Research (United States)

    A new clinical trial is testing ONC201, an investigational drug that in laboratory studies has been shown to kill breast and endometrial cancer cells most likely by destroying mitochondria within the tumor cells. Mitochondria are the “powerhouse” of the cell, and blocking its activity may kill tumor cells and shrink tumors in human patients.

  9. Results of the in vitro ring trial:. Thorium and uranium isotopes in urine

    International Nuclear Information System (INIS)

    Hartmann, M.; Dalheimer, A.; Haenisch, K.


    On 22 September 2004 a workshop was held at the Berlin branch of the Federal Radiation Protection Office (BfS) on the in vitro ring trial ''Th isotopes and U isotopes in urine'' organised by the BfS head office for incorporation monitoring. The workshop was attended by 11 experts from the German, Austrian and Swiss incorporation measurement stations participating in the ring trial. The main focus of this second workshop was on the presentation of the results of the ring trial concerning Th and U isotopes in urine. According to paragraph 41 (8) of the Federal Radiation Protection Ordinance (StrlSchV 2001) one of the responsibilities of the head office for incorporation monitoring in terms of quality assurance is to have ring trials performed by the excretion analysis laboratories designated by the competent authorities as measurement stations. Section 5.2 of the Guideline on Requirements for Incorporation Monitoring Stations still in force (referred to in the following as the ''Requirements Guideline''/Guideline 1996) stipulates that incorporation measurement stations whose scope includes this type of measurement are obliged to participate in such ring trials. Inofficial and foreign incorporation measurement stations are also entitled to participate in ring trials organised by the head office. Ring trials may comprise either data acquisition or the dosimetric interpretation of data or both. By participating in ring trials measurement stations are supposed to demonstrate that the analysis and measurement methods they use are capable of supplying correct results with sufficient precision within the required time frame and of providing dosimetrically correct interpretations of activity increases

  10. Pretreatment data is highly predictive of liver chemistry signals in clinical trials. (United States)

    Cai, Zhaohui; Bresell, Anders; Steinberg, Mark H; Silberg, Debra G; Furlong, Stephen T


    The goal of this retrospective analysis was to assess how well predictive models could determine which patients would develop liver chemistry signals during clinical trials based on their pretreatment (baseline) information. Based on data from 24 late-stage clinical trials, classification models were developed to predict liver chemistry outcomes using baseline information, which included demographics, medical history, concomitant medications, and baseline laboratory results. Predictive models using baseline data predicted which patients would develop liver signals during the trials with average validation accuracy around 80%. Baseline levels of individual liver chemistry tests were most important for predicting their own elevations during the trials. High bilirubin levels at baseline were not uncommon and were associated with a high risk of developing biochemical Hy's law cases. Baseline γ-glutamyltransferase (GGT) level appeared to have some predictive value, but did not increase predictability beyond using established liver chemistry tests. It is possible to predict which patients are at a higher risk of developing liver chemistry signals using pretreatment (baseline) data. Derived knowledge from such predictions may allow proactive and targeted risk management, and the type of analysis described here could help determine whether new biomarkers offer improved performance over established ones.

  11. Aespoe hard rock laboratory Sweden

    International Nuclear Information System (INIS)


    The aim of the new Aespoe hard rock laboratory is to demonstrate state of the art of technology and evaluation methods before the start of actual construction work on the planned deep repository for spent nuclear fuel. The nine country OECD/NEA project in the Stripa mine in Sweden has been an excellent example of high quality international research co-operation. In Sweden the new Aespoe hard rock laboratory will gradually take over and finalize this work. SKB very much appreciates the continued international participation in Aespoe which is of great value for the quality efficiency, and confidence in this kind of work. We have invited a number of leading experts to this first international seminar to summarize the current state of a number of key questions. The contributions show the great progress that has taken place during the years. The results show that there is a solid scientific basis for using this knowledge on site specific preparation and work on actual repositories. (au)

  12. Laboratory Measurements of Particulate Matter Concentrations from Asphalt Pavement Abrasion

    Directory of Open Access Journals (Sweden)

    Fullová Daša


    Full Text Available The issue of emissions from road traffic is compounded by the fact that the number of vehicles and driven kilometres increase each year. Road traffic is one of the main sources of particulate matter and traffic volume is still increasing and has unpleasant impact on longevity of the pavements and the environment. Vehicle motions cause mechanical wearing of the asphalt pavement surface - wearing course by vehicle tyres. The contribution deals with abrasion of bituminous wearing courses of pavements. The asphalt mixtures of wearing courses are compared in terms of mechanically separated particulate matter. The samples of asphalt mixtures were rutted in wheel tracking machine. The particulate matter measurements were performed in laboratory conditions. The experimental laboratory measurements make it possible to sample particulates without contamination from exhaust emissions, abraded particles from vehicles, resuspension of road dust and climate affects. The contribution offers partial results of measurements on six trial samples of asphalt mixtures with different composition. It presents particulate matter morphology and the comparison of rutted asphalt samples in terms of PM mass concentrations and chemical composition.

  13. Efficacy of Supportive Therapy of Allergic Rhinitis by Stinging Nettle (Urtica dioica) root extract: a Randomized, Double-Blind, Placebo- Controlled, Clinical Trial. (United States)

    Bakhshaee, Mehdi; Mohammad Pour, Amir Hooshang; Esmaeili, Majid; Jabbari Azad, Farahzad; Alipour Talesh, Ghazal; Salehi, Maryam; Noorollahian Mohajer, Morteza


    The aim of this study was to survey the exact benefit of this herb in the management of clinical and laboratory signs and symptoms of allergic rhinitis. In a randomized double blind clinical trial, 74 patients with the signs and symptoms of allergic rhinitis and a positive skin prick test were selected and randomly divided into 2 groups who were taken Urtica dioica 150-mg, Urtidin ® F.C Tablet) or placebo for one month. Their signs and symptoms, eosinophil percentage on nasal smear, serum IgE, and interleukin IL-4, IL-5, interferon- γ) levels were recorded. Forty patients completed the trial. Based on the Sino- Nasal Outcome Test 22 SNOT-22), a significant improvement in clinical symptom severity was observed in both groups P Nettle P Nettle saw no significant changes P > .1). Intergroup pre- and post-treatment laboratory findings suggested that there was a significant difference in post-treatment changes of mean IFN γ levels between the study and placebo group P = 0.017). Although the current study showed certain positive effects of Nettle in the management of allergic rhinitis on controlling the symptoms based on the SNOT-22, similar effects were demonstrated by placebo as well. We believe that our limitations underscore the need for larger, longer term studies of Nettle for the treatment of allergic rhinitis.

  14. Improvement of AOAC Official Method 984.27 for the determination of nine nutritional elements in food products by Inductively coupled plasma-atomic emission spectroscopy after microwave digestion: single-laboratory validation and ring trial. (United States)

    Poitevin, Eric; Nicolas, Marine; Graveleau, Laetitia; Richoz, Janique; Andrey, Daniel; Monard, Florence


    A single-laboratory validation (SLV) and a ring trial (RT) were undertaken to determine nine nutritional elements in food products by inductively coupled plasma-atomic emission spectroscopy in order to improve and update AOAC Official Method 984.27. The improvements involved optimized microwave digestion, selected analytical lines, internal standardization, and ion buffering. Simultaneous determination of nine elements (calcium, copper, iron, potassium, magnesium, manganese, sodium, phosphorus, and zinc) was made in food products. Sample digestion was performed through wet digestion of food samples by microwave technology with either closed or open vessel systems. Validation was performed to characterize the method for selectivity, sensitivity, linearity, accuracy, precision, recovery, ruggedness, and uncertainty. The robustness and efficiency of this method was proved through a successful internal RT using experienced food industry laboratories. Performance characteristics are reported for 13 certified and in-house reference materials, populating the AOAC triangle food sectors, which fulfilled AOAC criteria and recommendations for accuracy (trueness, recovery, and z-scores) and precision (repeatability and reproducibility RSD and HorRat values) regarding SLV and RT. This multielemental method is cost-efficient, time-saving, accurate, and fit-for-purpose according to ISO 17025 Norm and AOAC acceptability criteria, and is proposed as an improved version of AOAC Official Method 984.27 for fortified food products, including infant formula.

  15. Secondary standards laboratories for ionizing radiation calibrations: the national laboratory interests

    International Nuclear Information System (INIS)

    Roberson, P.L.; Campbell, G.W.


    The national laboratories are probable candidates to serve as secondary standards laboratories for the federal sector. Representatives of the major Department of Energy laboratories were polled concerning attitudes toward a secondary laboratory structure. Generally, the need for secondary laboratories was recognized and the development of such a program was encouraged. The secondary laboratories should be reviewed and inspected by the National Bureau of Standards. They should offer all of the essential, and preferably additional, calibration services in the field of radiological health protection. The selection of secondary laboratories should be based on economic and geographic criteria and/or be voluntary. 1 ref., 2 tabs

  16. Calculating Outsourcing Strategies and Trials of Strength

    DEFF Research Database (Denmark)

    Christensen, Mark; Skærbæk, Peter; Tryggestad, Kjell

    . The alternative option was an immediate outsourcing strategy with facility services being the object of large cross-functional contracts for all Danish military establishments. By succeeding in presenting ‘internal optimization’ as an outsourcing option (as opposed to the usual ‘make’ option) this case...... outsourcing strategies during a series of trials of strength, 2. develops the concept of ‘trial of strength’ for accounting and organization research by showing how ‘the rules of the game’ for the trials of strength can become challenged and controversial, 3. shows that, in addition to the pervasive role......Public sector outsourcing is a program within a suite of contemporary reforms mobilizing private enterprises in the belief of a more efficient public sector. Danish Armed Forces outsourcing of its facility services and management emerged as an option in 1991. Two strategic options developed: one...

  17. In vitro development of donated frozen-thawed human embryos in a prototype static microfluidic device: a randomized controlled trial

    NARCIS (Netherlands)

    Kieslinger, Dorit C.; Hao, Zhenxia; Vergouw, Carlijn G.; Kostelijk, Elisabeth H.; Lambalk, Cornelis B.; le Gac, Severine

    Objective: To compare the development of human embryos in microfluidic devices with culture in standard microdrop dishes, both under static conditions. Design: Prospective randomized controlled trial. Setting: In vitro fertilization laboratory. Patient(s): One hundred eighteen donated frozen-thawed

  18. Laboratory Information Management Systems for Forensic Laboratories: A White Paper for Directors and Decision Makers

    Energy Technology Data Exchange (ETDEWEB)

    Anthony Hendrickson; Brian Mennecke; Kevin Scheibe; Anthony Townsend


    Modern, forensics laboratories need Laboratory Information Management Systems (LIMS) implementations that allow the lab to track evidentiary items through their examination lifecycle and also serve all pertinent laboratory personnel. The research presented here presents LIMS core requirements as viewed by respondents serving in different forensic laboratory capacities as well as different forensic laboratory environments. A product-development methodology was employed to evaluate the relative value of the key features that constitute a LIMS, in order to develop a set of relative values for these features and the specifics of their implementation. In addition to the results of the product development analysis, this paper also provides an extensive review of LIMS and provides an overview of the preparation and planning process for the successful upgrade or implementation of a LIMS. Analysis of the data indicate that the relative value of LIMS components are viewed differently depending upon respondents' job roles (i.e., evidence technicians, scientists, and lab management), as well as by laboratory size. Specifically, the data show that: (1) Evidence technicians place the most value on chain of evidence capabilities and on chain of custody tracking; (2) Scientists generally place greatest value on report writing and generation, and on tracking daughter evidence that develops during their analyses; (3) Lab. Managers place the greatest value on chain of custody, daughter evidence, and not surprisingly, management reporting capabilities; and (4) Lab size affects LIMS preference in that, while all labs place daughter evidence tracking, chain of custody, and management and analyst report generation as their top three priorities, the order of this prioritization is size dependent.

  19. Coronary Catheterization Laboratory Role for Post-Resuscitation Care Without ST Elevation Myocardial Infarction. (United States)

    Kumar, Kris; Lotun, Kapildeo


    Out of hospital cardiac arrest management of patients with non-ST myocardial infarction per current American Heart Association and European Resuscitation Council guidelines leave the decision in regard to early angiography up to the physician operators. Guidelines are clear on the positive impact of early intervention on survival and improvement on left ventricular function in patients presenting with cardiac arrest and ST elevation myocardial infarction on electrocardiogram. This review aims to analyze the data that current guidelines are based upon in regards to out of hospital cardiac arrest with electrocardiogram findings of non-ST elevation myocardial infarction as well as other clinical trials that support early angiography and reperfusion strategies as well as future studies that are in trial to study the role of the coronary catheterization laboratory in cardiac arrest. Copyright© Bentham Science Publishers; For any queries, please email at

  20. Mobile spectrometric laboratory

    International Nuclear Information System (INIS)

    Isajenko, K.A.; Lipinski, P.


    The article presents the Mobile Spectrometric Laboratory used by Central Laboratory for Radiological Protection since year 2000. The equipment installed in the Mobile Laboratory and its uses is described. The results of international exercises and intercalibrations, in which the Laboratory participated are presented. (author)

  1. Geographic differences in time to culture conversion in liquid media: Tuberculosis Trials Consortium study 28. Culture conversion is delayed in Africa.

    Directory of Open Access Journals (Sweden)

    William R Mac Kenzie


    Full Text Available Tuberculosis Trials Consortium Study 28, was a double blind, randomized, placebo-controlled, phase 2 clinical trial examining smear positive pulmonary Mycobacterium tuberculosis. Over the course of intensive phase therapy, patients from African sites had substantially delayed and lower rates of culture conversion to negative in liquid media compared to non-African patients. We explored potential explanations of this finding.In TBTC Study 28, protocol-correct patients (n = 328 provided spot sputum specimens for M. tuberculosis culture in liquid media, at baseline and weeks 2, 4, 6 and 8 of study therapy. We compared sputum culture conversion for African and non-African patients stratified by four baseline measures of disease severity: AFB smear quantification, extent of disease on chest radiograph, cavity size and the number of days to detection of M. tuberculosis in liquid media using the Kaplan-Meier product-limit method. We evaluated specimen processing and culture procedures used at 29 study laboratories serving 27 sites.African TB patients had more extensive disease at enrollment than non-African patients. However, African patients with the least disease by the 4 measures of disease severity had conversion rates on liquid media that were substantially lower than conversion rates in non-African patients with the greatest extent of disease. HIV infection, smoking and diabetes did not explain delayed conversion in Africa. Some inter-site variation in laboratory processing and culture procedures within accepted practice for clinical diagnostic laboratories was found.Compared with patients from non-African sites, African patients being treated for TB had delayed sputum culture conversion and lower sputum conversion rates in liquid media that were not explained by baseline severity of disease, HIV status, age, smoking, diabetes or race. Further investigation is warranted into whether modest variation in laboratory processes substantially

  2. Clinical Trials

    Medline Plus

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

  3. Clinical Trials

    Medline Plus

    Full Text Available ... to-kol). This plan explains how the trial will work. The trial is led by a principal ... for the clinical trial. The protocol outlines what will be done during the clinical trial and why. ...

  4. Clinical Trials

    Medline Plus

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

  5. Clinical Trials

    Medline Plus

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

  6. Clinical Trials

    Medline Plus

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

  7. Clinical Trials

    Medline Plus

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

  8. Clinical Trials

    Medline Plus

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

  9. Infections in British clinical laboratories, 1986-87.


    Grist, N R; Emslie, J A


    During 1986-87 this continuing survey showed 15 specific infections in the staff of 235 laboratories, representing 28,524 person years of exposure. The community was the probable source of four of the five cases of tuberculosis and one of the five cases of salmonellosis. Occupational exposure was the probable cause of four infections by Shigella flexneri, three by Salmonella typhimurium, and one by S typhi, all affecting medical laboratory scientific officers (MLSOs) in microbiology. Occupati...

  10. 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.


    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

  11. A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder

    Directory of Open Access Journals (Sweden)

    Childress Ann C


    Full Text Available Abstract Background Lisdexamfetamine dimesylate (LDX is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD in children 6 to 12 years of age and in adults. In a previous laboratory school study, LDX demonstrated efficacy 2 hours postdose with duration of efficacy through 12 hours. The current study further characterizes the time course of effect of LDX. Methods Children aged 6 to 12 years with ADHD were enrolled in a laboratory school study. The multicenter study consisted of open-label, dose-optimization of LDX (30, 50, 70 mg/d, 4 weeks followed by a randomized, placebo-controlled, 2-way crossover phase (1 week each. Efficacy measures included the SKAMP (deportment [primary] and attention [secondary] and PERMP (attempted/correct scales (secondary measured at predose and at 1.5, 2.5, 5, 7.5, 10, 12, and 13 hours postdose. Safety measures included treatment-emergent adverse events (AEs, physical examination, vital signs, and ECGs. Results A total of 117 subjects were randomized and 111 completed the study. Compared with placebo, LDX demonstrated significantly greater efficacy at each postdose time point (1.5 hours to 13.0 hours, as measured by SKAMP deportment and attention scales and PERMP (P Conclusion In school-aged children (6 to 12 years with ADHD, efficacy of LDX was maintained from the first time point (1.5 hours up to the last time point assessed (13.0 hours. LDX was generally well tolerated, resulting in typical stimulant AEs. Trial registration Official Title: A Phase IIIb, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Dose-Optimization, Cross-Over, Analog Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate in Pediatric Subjects Aged 6–12 With Attention-Deficit/Hyperactivity Disorder. Identifier: NCT00500149

  12. Research programs at the Department of Energy National Laboratories. Volume 2: Laboratory matrix

    Energy Technology Data Exchange (ETDEWEB)



    For nearly fifty years, the US national laboratories, under the direction of the Department of Energy, have maintained a tradition of outstanding scientific research and innovative technological development. With the end of the Cold War, their roles have undergone profound changes. Although many of their original priorities remain--stewardship of the nation`s nuclear stockpile, for example--pressing budget constraints and new federal mandates have altered their focus. Promotion of energy efficiency, environmental restoration, human health, and technology partnerships with the goal of enhancing US economic and technological competitiveness are key new priorities. The multiprogram national laboratories offer unparalleled expertise in meeting the challenge of changing priorities. This volume aims to demonstrate each laboratory`s uniqueness in applying this expertise. It describes the laboratories` activities in eleven broad areas of research that most or all share in common. Each section of this volume is devoted to a single laboratory. Those included are: Argonne National Laboratory; Brookhaven National Laboratory; Idaho National Engineering Laboratory; Lawrence Berkeley Laboratory; Lawrence Livermore National Laboratory; Los Alamos National Laboratory; National Renewable Energy Laboratory; Oak Ridge National Laboratory; Pacific Northwest Laboratory; and Sandia National Laboratories. The information in this volume was provided by the multiprogram national laboratories and compiled at Lawrence Berkeley Laboratory.

  13. Inter-laboratory optimization of protein extraction, separation, and fluorescent detection of endogenous rice allergens. (United States)

    Satoh, Rie; Teshima, Reiko; Kitta, Kazumi; Lang, Gang-Hua; Schegg, Kathleen; Blumenthal, Kenneth; Hicks, Leslie; Labory-Carcenac, Bénédicte; Rouquié, David; Herman, Rod A; Herouet-Guicheney, Corinne; Ladics, Gregory S; McClain, Scott; Poulsen, Lars K; Privalle, Laura; Ward, Jason M; Doerrer, Nancy; Rascle, Jean-Baptiste


    In rice, several allergens have been identified such as the non-specific lipid transfer protein-1, the α-amylase/trypsin-inhibitors, the α-globulin, the 33 kDa glyoxalase I (Gly I), the 52-63 kDa globulin, and the granule-bound starch synthetase. The goal of the present study was to define optimal rice extraction and detection methods that would allow a sensitive and reproducible measure of several classes of known rice allergens. In a three-laboratory ring-trial experiment, several protein extraction methods were first compared and analyzed by 1D multiplexed SDS-PAGE. In a second phase, an inter-laboratory validation of 2D-DIGE analysis was conducted in five independent laboratories, focusing on three rice allergens (52 kDa globulin, 33 kDa glyoxalase I, and 14-16 kDa α-amylase/trypsin inhibitor family members). The results of the present study indicate that a combination of 1D multiplexed SDS-PAGE and 2D-DIGE methods would be recommended to quantify the various rice allergens.

  14. Sandia Laboratories technical capabilities. Auxiliary capabilities: environmental health information science

    International Nuclear Information System (INIS)


    Sandia Laboratories is an engineering laboratory in which research, development, testing, and evaluation capabilities are integrated by program management for the generation of advanced designs. In fulfilling its primary responsibility to ERDA, Sandia Laboratories has acquired extensive research and development capabilities. The purpose of this series of documents is to catalog the many technical capabilities of the Laboratories. After the listing of capabilities, supporting information is provided in the form of highlights, which show applications. This document deals with auxiliary capabilities, in particular, environmental health and information science. (11 figures, 1 table) (RWR)

  15. Queensland Mines plant trials with Caro's acid

    International Nuclear Information System (INIS)

    Lucas, G.C.; Fulton, E.J.; Vautier, F.E.; Waters, D.J.; Ring, R.J.


    Laboratory leach tests have been carried out to compare the effectiveness of Caro's acid (permonosulphuric acid) as an alternative oxidant to pyrolusite in the leaching of uranium ores. Results demonstrated that Caro's acid reduced acid consumption in leaching and the time required for neutralisation of tailings liquor. The uranium extraction was unaffected by choice of oxidant. A plant trial confirmed that significant savings in acid and lime usage can be achieved under plant conditions. Plant operations also demonstrated that Caro's acid has a number of significant operating advantages over pyrolusite. Queensland Mines Ltd. have recently decided to convert their leaching process from pyrolusite to Caro's acid

  16. The Helicobacter Eradication Aspirin Trial (HEAT: A Large Simple Randomised Controlled Trial Using Novel Methodology in Primary Care

    Directory of Open Access Journals (Sweden)

    Jennifer S. Dumbleton


    Discussion: HEAT is important medically, because aspirin is so widely used, and methodologically, as a successful trial would show that large-scale studies of important clinical outcomes can be conducted at a fraction of the cost of those conducted by industry, which in turn will help to ensure that trials of primarily medical rather than commercial interest can be conducted successfully in the UK.

  17. Implementation of the CNEN's safeguards laboratory

    International Nuclear Information System (INIS)

    Almeida, S.G. de


    The International Safeguards Agreements between Brazil and others countries has been concluded with the participation of the International Atomic Energy Agency (AIEA), and involve the Physical Protection and Control of Nuclear Material activities, which set up the National Safeguards System. The Safeguards Laboratory was constructed to the implementation and maintenance of this National Safeguards System, under responsability of CNEN's Safeguards Division, in order to carry out measurements of nuclear materials under safeguards. Technical requirements applied to the construction, setting up and operation of the laboratory are showed. The first results refer to the implementation of safeguards methods and techniques, as well as its participation within international scientific and technical co-operation programs in the safeguards area, through of them we wait its credencement by the AIEA as Regional Safeguards Laboratory for every countries of the Latin America. (Author) [pt

  18. Toxicity of emamectin benzoate to Cydia pomonella (L.) and Cydia molesta (Busck) (Lepidoptera: Tortricidae): laboratory and field tests. (United States)

    Ioriatti, Claudio; Anfora, Gianfranco; Angeli, Gino; Civolani, Stefano; Schmidt, Silvia; Pasqualini, Edison


    Emamectin benzoate is a novel macrocyclic lactone insecticide derived from naturally occurring avermectin molecules isolated by fermentation from the soil microorganism Streptomyces avermitilis Kim & Goodfellow. The present study aims to evaluate the toxicity of emamectin benzoate to codling moth, Cydia pomonella (L.), and oriental fruit moth, C. molesta (Busck), under laboratory and semi-field conditions. Dose response bioassays showed that emamectin benzoate had a high level of intrinsic toxicity to early-stage larvae of both species, and that contact activity might contribute significantly to mortality. In the semi-field trials, residual toxicity lasted for more than 1 week. Ovicidal activity was recorded only for C. pomonella (approximately 30%), irrespective of the concentrations tested. Field trials confirmed the efficacy of emamectin benzoate on codling moth when applied at 7 day intervals. Fruit damage, both from the first and second generations, was comparable with that on treatment with chlorpyrifos-ethyl, used as a chemical reference. Emamectin benzoate may be considered a valuable tool for the control of codling moth as a component of an IPM programme. Its collective advantages are: high efficacy, lack of cross-resistance with currently used products, control of secondary pests such as oriental fruit moth and selective toxicity that spares beneficials. 2008 Society of Chemical Industry

  19. Magnitude of effects in clinical trials published in high-impact general medical journals. (United States)

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


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

  20. Nanotechnology Characterization Laboratory (United States)

    Federal Laboratory Consortium — The Nanotechnology Characterization Laboratory (NCL) at the Frederick National Laboratory for Cancer Research performs preclinical characterization of nanomaterials...

  1. Semiconductor Electrical Measurements Laboratory (United States)

    Federal Laboratory Consortium — The Semiconductor Electrical Measurements Laboratory is a research laboratory which complements the Optical Measurements Laboratory. The laboratory provides for Hall...

  2. Part I: Virtual laboratory versus traditional laboratory: Which is more effective for teaching electrochemistry? Part II: The green synthesis of aurones using a deep eutectic solvent (United States)

    Hawkins, Ian C.

    The role of the teaching laboratory in science education has been debated over the last century. The goals and purposes of the laboratory are still debated and while most science educators consider laboratory a vital part of the education process, they differ widely on the purposes for laboratory and what methods should be used to teach laboratory. One method of instruction, virtual labs, has become popular among some as a possible way of capitalizing on the benefits of lab in a less costly and more time flexible format. The research regarding the use of virtual labs is limited and the few studies that have been done on General Chemistry labs do not use the virtual labs as a substitute for hands-on experiences, but rather as a supplement to a traditional laboratory program. This research seeks to determine the possible viability of a virtual simulation to replace a traditional hands-on electrochemistry lab in the General Chemistry II course sequence. The data indicate that for both content knowledge and the development of hands-on skills the virtual lab showed no significant difference in overall scores on the assessments, but that an individual item related to the physical set-up of a battery showed better scores for the hands-on labs over the virtual labs. Further research should be done to determine if these results are similar in other settings with the use of different virtual labs and how the virtual labs compare to other laboratories using different learning styles and learning goals. One often cited purpose of laboratory experiences in the context of preparing chemists is to simulate the experiences common in chemical research so graduate experience in a research laboratory was a necessary part of my education in the field of laboratory instruction. This research experience provided me the opportunity, to complete an organic synthesis of aurones using a deep eutectic solvent. These solvents show unique properties that make them a viable alternative to ionic


    These reports summarize pollution prevention opportunity assessments conducted jointly by EPA and DOE at the Geochemistry Laboratory and the Manufacturing and Fabrication Repair Laboratory at the Department of Energy's Sandia National Laboratories facility in Albuquerque, New Mex...

  4. Transparency in ovarian cancer clinical trial results: versus PubMed, Embase and Google scholar. (United States)

    Roberto, Anna; Radrezza, Silvia; Mosconi, Paola


    In recent years the question of the lack of transparency in clinical research has been debated by clinicians, researchers, citizens and their representatives, authors and publishers. This is particularly important for infrequent cancers such as ovarian cancer, where treatment still gives disappointing results in the majority of cases. Our aim was to assess the availability to the public of results in, and the frequency of non-publication of results in and in PubMed, Embase and Google Scholar. We collected all trials on ovarian cancer identified as "completed status" in the registry on 17 January 2017. We checked the availability of the results in and systematically identified published manuscripts on results. Out of 2725 trials on ovarian cancer identified, 752 were classified as "completed status". In those closed between 2008 and 2015, excluding phase I, the frequency of results in was 35%. Of the 752 completed studies the frequency of published results in PubMed, Embase or Google Scholar ranged from 57.9% to 69.7% in the last years. These findings show a lack of transparency and credibility of research. Citizens or patients' representatives, with the medical community, should continuously support initiatives to improve the publication and dissemination of clinical study results.

  5. Remune trial will stop; new trials planned. (United States)

    James, J S


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

  6. Bio Engineering Laboratory (United States)

    Federal Laboratory Consortium — Description/History: Chemistry and biology laboratoriesThe Bio Engineering Laboratory (BeL) is theonly full spectrum biotechnology capability within the Department...

  7. Citicoline for ischemic stroke: ICTUS trial

    Directory of Open Access Journals (Sweden)

    Vladimir Anatolyevich Parfenov


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

  8. Laboratory Tests of Multiplex Detection of PCR Amplicons Using the Luminex 100 Flow Analyzer

    Energy Technology Data Exchange (ETDEWEB)

    Venkateswaran, K.S.; Nasarabadi, S.; Langlois, R.G.


    Lawrence Livermore National Laboratory (LLNL) demonstrated the power of flow cytometry in detecting the biological agents simulants at JFT III. LLNL pioneered in the development of advanced nucleic acid analyzer (ANM) for portable real time identification. Recent advances in flow cytometry provide a means for multiplexed nucleic acid detection and immunoassay of pathogenic microorganisms. We are presently developing multiplexed immunoassays for the simultaneous detection of different simulants. Our goal is to build an integrated instrument for both nucleic acid analysis and immuno detection. In this study we evaluated the Luminex LX 100 for concurrent identification of more than one PCR amplified product. ANAA has real-time Taqman fluorescent detection capability for rapid identification of field samples. However, its multiplexing ability is limited by the combination of available fluorescent labels. Hence integration of ANAA with flow cytometry can give the rapidity of ANAA amplification and the multiplex capability of flow cytometry. Multiplexed flow cytometric analysis is made possible using a set of fluorescent latex microsphere that are individually identified by their red and infrared fluorescence. A green fluorochrome is used as the assay signal. Methods were developed for the identification of specific nucleic acid sequences from Bacillus globigii (Bg), Bacillus thuringensis (Bt) and Erwinia herbicola (Eh). Detection sensitivity using different reporter fluorochromes was tested with the LX 100, and also different assay formats were evaluated for their suitability for rapid testing. A blind laboratory trial was carried out December 22-27, 1999 to evaluate bead assays for multiplex identification of Bg and Bt PCR products. This report summarizes the assay development, fluorochrome comparisons, and the results of the blind trial conducted at LLNL for the laboratory evaluation of the LX 100 flow analyzer.

  9. Clinical Trials

    Medline Plus

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

  10. EDF plan for a dispersant injection trial

    International Nuclear Information System (INIS)

    Mercier, Stephane; Corredera, Geraldine; Alves-Vieira, Maria; Mansour, Carine; You, Dominique


    In its strategy for SG fouling control, EDF is considering the use of dispersant as a preventive remedy. A trial on Golfech 2 started in May 2012. The dispersant selected for the trial is Polyacrylic Acid (PAA). The main goals of the test are to check and quantify the gain on iron transport to blowdown, to evaluate the possible effects on secondary side chemistry and the operational costs of the injection - reactant, ion exchange resins and filters. The results of the test, if satisfying, will be used to set EDF strategy for dispersant long term use on its fleet. So, one concern about the trial is to make sure that the conclusions of this test will be applicable to a wide range of EDF plants. For that purpose, several criteria have been examined for the choice of the candidate plant such as fouling level, secondary circuit materials (presence or absence of copper alloys,...), SG tube material, thermal power margin, secondary side chemistry (amine used and pH applied). Before starting the trial, EDF had to take into account the international feedback and to adapt it to its specific requirements: the neutralization amine was switched from ETA to morpholine, additional work had been completed to validate the innocuousness of PAA injection for EDF plants... This work especially includes laboratory testing of secondary side corrosion cracking in the presence of PAA and water chemistries used in EdF plants. Moreover, investigation on the thermal stability of PAA and degradation products was completed and further evaluation of environmental impact was performed. A dedicated skid for the injection of PAA was implemented in Golfech Chemicals injection room. The installation and the process were notably designed to take into account the high viscosity of the commercial product, and the need to proceed to a good rinsing of the pipes without increasing the discharged effluents. The first available data from Golfech 2 trial are also provided and discussed. (authors)

  11. Clinical trials of boron neutron capture therapy [in humans] [at Beth Israel Deaconess Medical Center][at Brookhaven National Laboratory

    International Nuclear Information System (INIS)

    Wallace, Christine


    Assessment of research records of Boron Neutron Capture Therapy was conducted at Brookhaven National Laboratory and Beth Israel Deaconess Medical Center using the Code of Federal Regulations, FDA Regulations and Good Clinical Practice Guidelines. Clinical data were collected FR-om subjects' research charts, and differences in conduct of studies at both centers were examined. Records maintained at Brookhaven National Laboratory were not in compliance with regulatory standards. Beth Israel's records followed federal regulations. Deficiencies discovered at both sites are discussed in the reports

  12. The capacity of diagnostic laboratories in Kenya for detecting infectious diseases. (United States)

    Slotved, H-C; Yatich, Kennedy K; Sam, Shem Otoi; Ndhine, Edwardina Otieno


    The aim of this study is to present data of the diagnostic capacity of Kenyan laboratories to diagnose a number of human pathogens. The study is based on the data obtained from a biosecurity survey conducted in Kenya in 2014/2015 and data from the Statistical Abstract of Kenya for 2015. The biosecurity survey has previously been published; however, the survey also included information on laboratory capacity to handle a number of pathogens, which have not been published. Data were retrieved from the survey on 86 laboratory facilities. The data include information from relevant categories such as training laboratories, human diagnostic laboratories, veterinary diagnostic laboratories, and research laboratories. The disease incidence in Kenya ranges widely from malaria and diarrhea with an incidence rate of around 10.000 per year to diseases such as cholera and yellow fever with an incidence rate of 1 per year or less for all age groups. The data showed that diseases with the highest number of diagnostic facilities were mainly malaria-, HIV-, tuberculosis-, and diarrhea-related infectious diseases. The study generally shows that the laboratory facilities have the capacity of detecting the infectious diseases with the highest incidence rates. Furthermore, it seems that the number of facilities able to detect a particular disease is related to the incidence rate of the disease.

  13. Advanced Chemistry Laboratory (United States)

    Federal Laboratory Consortium — Description/History: Chemistry laboratoryThe Advanced Chemistry Laboratory (ACL) is a unique facility designed for working with the most super toxic compounds known...


    Federal Laboratory Consortium — This laboratory provides biomechanical and physical analyses for both military and commercial footwear. The laboratory contains equipment that is integral to the us...

  15. On cosmology in the laboratory. (United States)

    Leonhardt, Ulf


    In transformation optics, ideas from general relativity have been put to practical use for engineering problems. This article asks the question how this debt can be repaid. In discussing a series of recent laboratory experiments, it shows how insights from wave phenomena shed light on the quantum physics of the event horizon.

  16. Medical laboratories in sub-Saharan Africa that meet international quality standards. (United States)

    Schroeder, Lee F; Amukele, Timothy


    A recent survey of laboratories in Kampala, Uganda, demonstrated that only 0.3% of laboratories (3/954) met international quality standards. To benchmark laboratory quality throughout the rest of sub-Saharan Africa (SSA), we compiled a list of SSA laboratories meeting international quality standards. Accrediting bodies were queried via online registries or direct communication in May 2013. There were 380 laboratories accredited to international standards in SSA. Ninety-one percent were in South Africa. Thirty-seven of 49 countries had no laboratories accredited to international quality standards. Accredited laboratory density (per million people) in South Africa, Namibia, and Botswana were similar to those in many European countries. Single variable linear regression showed a correlation between accredited laboratory density and health expenditures per person (adjusted R(2) = 0.81, P clinical laboratory. For those that do, there is a strong correlation between country-specific accredited laboratory density and per-capita health expenditures. Copyright© by the American Society for Clinical Pathology.

  17. Government-industry-uUniversity and rResearch lLaboratories cCoordination for new product development: Session 2. Government research laboratory perspective

    International Nuclear Information System (INIS)

    Kuzay, T.M.


    This talk is the second in an expanded series of presentations on the Government-Industry-University and Research Laboratories Coordination for new product development, which is a timely and important public policy issue. Such interactions have become particularly timely in light of the present decline in funding for research and development (R ampersand D) in the nation''s budget and in the private sector. These interactions, at least in principle, provide a means to maximize benefits for the greater good of the nation by pooling the diminishing resources. National laboratories, which traditionally interacted closely with the universities in educational training, now are able to also participate closely with industry in joint R ampersand D thanks to a number of public laws legislated since the early 80s. A review of the experiences with such interactions at Argonne National Laboratory, which exemplifies the national laboratories, shows that, despite differences in their traditions and the missions, the national laboratory-industry-university triangle can work together

  18. Automated classification of eligibility criteria in clinical trials to facilitate patient-trial matching for specific patient populations. (United States)

    Zhang, Kevin; Demner-Fushman, Dina


    To develop automated classification methods for eligibility criteria in to facilitate patient-trial matching for specific populations such as persons living with HIV or pregnant women. We annotated 891 interventional cancer trials from based on their eligibility for human immunodeficiency virus (HIV)-positive patients using their eligibility criteria. These annotations were used to develop classifiers based on regular expressions and machine learning (ML). After evaluating classification of cancer trials for eligibility of HIV-positive patients, we sought to evaluate the generalizability of our approach to more general diseases and conditions. We annotated the eligibility criteria for 1570 of the most recent interventional trials from for HIV-positive and pregnancy eligibility, and the classifiers were retrained and reevaluated using these data. On the cancer-HIV dataset, the baseline regex model, the bag-of-words ML classifier, and the ML classifier with named entity recognition (NER) achieved macro-averaged F2 scores of 0.77, 0.87, and 0.87, respectively; the addition of NER did not result in a significant performance improvement. On the general dataset, ML + NER achieved macro-averaged F2 scores of 0.91 and 0.85 for HIV and pregnancy, respectively. The eligibility status of specific patient populations, such as persons living with HIV and pregnant women, for clinical trials is of interest to both patients and clinicians. We show that it is feasible to develop a high-performing, automated trial classification system for eligibility status that can be integrated into consumer-facing search engines as well as patient-trial matching systems. Published by Oxford University Press on behalf of the American Medical Informatics Association 2017. This work is written by US Government employees and is in the public domain in the US.

  19. A multicenter, randomized trial comparing synthetic surfactant with modified bovine surfactant extract in the treatment of neonatal respiratory distress syndrome

    NARCIS (Netherlands)

    Adams, E; Vollman, J; Giebner, D; Maurer, M; Dreyer, G; Bailey, L; Anderson, M; Mefford, L; Beaumont, E; Sutton, D; Puppala, B; Mangurten, HH; Secrest, J; Lewis, WJ; Carteaux, P; Bednarek, F; Welsberger, S; Gosselin, R; Pantoja, AF; Belenky, A; Campbell, P; Patole, S; Duenas, M; Kelly, M; Alejo, W; Lewallen, P; DeanLieber, S; Hanft, M; Ferlauto, J; Newell, RW; Bagwell, J; Levine, D; Lipp, RW; Harkavy, K; Vasa, R; Birenbaum, H; Broderick, KA; Santos, AQ; Long, BA; Gulrajani, M; Stern, M; Hopgood, G; Hegyi, T; Alba, J; Christmas, L; McQueen, M; Nichols, N; Brown, M; Quissell, BJ; Rusk, C; Marks, K; Gifford, K; Hoehn, G; Pathak, A; Marino, B; Hunt, P; Fox, [No Value; Sharpstein, C; Feldman, B; Johnson, N; Beecham, J; Balcom, R; Helmuth, W; Boylan, D; Frakes, C; Magoon, M; Reese, K; Schwersenski, J; Schutzman, D; Soll, R; Horbar, JD; Leahy, K; Troyer, W; Juzwicki, C; Anderson, P; Dworsky, M; Reynolds, L; Urrutia, J; Gupta, U; Adray, C

    Objective. To compare the efficacy of a synthetic surfactant (Exosurf Neonatal, Burroughs-Wellcome Co) and a modified bovine surfactant extract (Survanta, Ross Laboratories) in the treatment of neonatal respiratory distress syndrome (RDS). Design. Multicenter, randomized trial. Setting. Thirty-eight

  20. Lincoln Laboratory Grid (United States)

    Federal Laboratory Consortium — The Lincoln Laboratory Grid (LLGrid) is an interactive, on-demand parallel computing system that uses a large computing cluster to enable Laboratory researchers to...

  1. Photometrics Laboratory (United States)

    Federal Laboratory Consortium — Purpose:The Photometrics Laboratory provides the capability to measure, analyze and characterize radiometric and photometric properties of light sources and filters,...

  2. Blackroom Laboratory (United States)

    Federal Laboratory Consortium — FUNCTION: Enables evaluation and characterization of materials ranging from the ultraviolet to the longwave infrared (LWIR).DESCRIPTION: The Blackroom Laboratory is...

  3. Use of 'sham' radiotherapy in randomized clinical trials

    International Nuclear Information System (INIS)

    Schwarz, F.; Christie, D.


    The objective of this systematic review was to identify quality trials that use sham radiotherapy in their design and review them to determine its potential value. The Cochrane Library, Pubmed and a Reference Search served as data sources. Trials were included if they met a minimum quality score of 3 on a validated assessment instrument (which assesses randomization, control and blinding) and if they compared sham radiotherapy to active treatment. External beam therapy and brachytherapy trials were considered. Twenty-six trials were identified, collectively including 2663 participants in the period of 1970-2004. All the trials studied the value of radiotherapy for treatment or prevention of benign diseases, including multiple sclerosis, coronary artery restenosis, age-related macular degeneration and Graves' ophthalmopathy. There were no trials relating to the use of radiotherapy in the treatment of malignancy. This review showed that it is possible to carry out sham radiotherapy with due regard for ethical concerns, with effective blinding and high levels of patient acceptance. Large sample sizes with multicentre trial designs were achievable. Although the statistical philosophy for using sham radiotherapy in trials is legitimate, it is no longer routinely used.

  4. Laboratory Building

    Energy Technology Data Exchange (ETDEWEB)

    Herrera, Joshua M. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)


    This report is an analysis of the means of egress and life safety requirements for the laboratory building. The building is located at Sandia National Laboratories (SNL) in Albuquerque, NM. The report includes a prescriptive-based analysis as well as a performance-based analysis. Following the analysis are appendices which contain maps of the laboratory building used throughout the analysis. The top of all the maps is assumed to be north.

  5. Clinical Trials

    Medline Plus

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

  6. Knowledge and practices of pharmaceutical laboratory workers on laboratory safety

    Directory of Open Access Journals (Sweden)

    Esra Emerce


    Full Text Available Laboratories are classified as very hazardous workplaces. Objective: The aim of this descriptive study was to determine the knowledge and practice of laboratory safety by analysts and technicians in the laboratories of the Turkish Medicine and Medical Devices Agency. Methods:  85.0% (n=93 of the workers (n=109 was reached. A pre-tested, laboratory safety oriented, self-administered questionnaire was completed under observation. Results: Participants were mostly female (66,7%, had 12.8±8.2 years of laboratory experience and worked 24.6±10.3 hours per week. 53.8% of the employees generally worked with flammable and explosive substances, 29.0% with acute toxic or carcinogenic chemicals and 30.1% with physical dangers. Of all surveyed, 14.0% had never received formal training on laboratory safety. The proportion of ‘always use’ of laboratory coats, gloves, and goggles were 84.9%, 66.7%, and 6.5% respectively. 11.9% of the participants had at least one serious injury throughout their working lives and 24.7% had at least one small injury within the last 6 months. Among these injuries, incisions, bites and tears requiring no stiches (21.0% and the inhalation of chemical vapors (16.1% took first place. The mean value for the number of correct responses to questions on basic safety knowledge was 65.4±26.5, out of a possible 100. Conclusion: Overall, the participants have failed in some safety practices and have been eager to get regular education on laboratory safety.  From this point onwards, it would be appropriate for the employers to organize periodic trainings on laboratory safety.Keywords: Health personnel, laboratory personnel, occupational health, occupational safety, pharmacy

  7. Clinical results of stereotactic hellium-ion radiosurgery of the pituitary gland at Lawrence Berkeley Laboratory

    International Nuclear Information System (INIS)

    Levy, R.P.; Fabrikant, J.I.; Lyman, J.T.; Frankel, K.A.; Phillips, M.H.; Lawrence, J.H.; Tobias, C.A.


    The first therapeutic clinical trial using accelerated heavy-charged particles in humans was performed at Lawrence Berkeley Laboratory (LBL) for the treatment of various endocrine and metabolic disorders of the pituitary gland, and as suppressive therapy for adenohypophyseal hormone-responsive carcinomas and diabetic retinopathy. In acromegaly, Cushing's disease, Nelson's syndrome and prolactin-secreting tumors, the therapeutic goal in the 433 patients treated has been to destroy or inhibit the growth of the pituitary tumor and control hormonal hypersecretion, while preserving a functional rim of tissue with normal hormone-secreting capacity, and minimizing neurologic injury. An additional group of 34 patients was treated for nonsecreting chromophobe adenomas. This paper discusses the methods and results of stereotactic helium-ion radiosurgery of the pituitary gland at Lawrence Berkeley Laboratory. 11 refs

  8. Clinical results of stereotactic hellium-ion radiosurgery of the pituitary gland at Lawrence Berkeley Laboratory

    Energy Technology Data Exchange (ETDEWEB)

    Levy, R.P.; Fabrikant, J.I.; Lyman, J.T.; Frankel, K.A.; Phillips, M.H.; Lawrence, J.H.; Tobias, C.A.


    The first therapeutic clinical trial using accelerated heavy-charged particles in humans was performed at Lawrence Berkeley Laboratory (LBL) for the treatment of various endocrine and metabolic disorders of the pituitary gland, and as suppressive therapy for adenohypophyseal hormone-responsive carcinomas and diabetic retinopathy. In acromegaly, Cushing's disease, Nelson's syndrome and prolactin-secreting tumors, the therapeutic goal in the 433 patients treated has been to destroy or inhibit the growth of the pituitary tumor and control hormonal hypersecretion, while preserving a functional rim of tissue with normal hormone-secreting capacity, and minimizing neurologic injury. An additional group of 34 patients was treated for nonsecreting chromophobe adenomas. This paper discusses the methods and results of stereotactic helium-ion radiosurgery of the pituitary gland at Lawrence Berkeley Laboratory. 11 refs.

  9. Implementation of 5S Method for Ergonomic Laboratory (United States)

    Dila Sari, Amarria; Ilma Rahmillah, Fety; Prabowo Aji, Bagus


    This article discusses 5S implementation in Work System Design and Ergonomic Laboratory, Department of Industrial Engineering, Islamic University of Indonesia. There are some problems related to equipment settings for activity involving students such as files which is accumulated over the previous year practicum, as well as the movement of waste in the form of time due to the placement of goods that do not fit. Therefore, this study aims to apply the 5S method in DSK & E laboratory to facilitate the work processes and reduce waste. The project is performed by laboratory management using 5S methods in response to continuous improvement (Kaizen). Moreover, some strategy and suggestions are promoted to impose 5S system within the laboratory. As a result, the tidiness and cleanliness can be achieved that lead to the great performance of laboratory users. Score assessment before implementing 5S DSKE laboratory is at 64 (2.56) while the score after implementation is 32 (1.28) and shows an improvement of 50%. This has implications for better use in the laboratory area, save time when looking for tools and materials due to its location and good visual control, as well as improving the culture and spirit of ‘5S’ on staff regarding better working environment

  10. Fire preparedness measures in buildings with hot laboratories

    International Nuclear Information System (INIS)

    Oberlaender, B.C.


    Important hot laboratory safety issues are the general design/construction of the building with respect to fire, fire prevention, fire protection, administrative controls, and risk assessment. Within the network of the European Working Group Hot Laboratories and Remote Handling items concerning 'fire preparedness measures in hot laboratories' were screened and studied. Two questionnaires were sent to European hot laboratories; the first in November 2002 on 'fire preparedness measures, fire detection and fire suppression/extinguishing in lead shielded cells, concrete shielded cells' and the second in June 2003 on 'Fire preparedness measures in buildings with hot laboratories'. The questionnaires were filled in by a total of ten hot laboratories in seven European countries. On request of participants the answers were evaluated and 'anonymised' for presentation and discussion at the plenary meeting. The answers showed that many European hot laboratories are implementing improvements to their fire protection programmes to comply with more stringent requirements of the national authorities. The recommendations ('International guidelines for the fire protection of Nuclear Power Plants') given by the insurance pools are followed up with national variations. An ISO standard (ISO 17873) is in progress giving criteria for the design and the operation of ventilation systems as well as fire hazard management in nuclear installations others than reactors

  11. Road Transportable Analytical Laboratory system

    International Nuclear Information System (INIS)

    Finger, S.M.; Keith, V.F.; Spertzel, R.O.; De Avila, J.C.; O'Donnell, M.; Vann, R.L.


    This developmental effort clearly shows that a Road Transportable Analytical Laboratory System is a worthwhile and achievable goal. The RTAL is designed to fully analyze (radioanalytes, and organic and inorganic chemical analytes) 20 samples per day at the highest levels of quality assurance and quality control. It dramatically reduces the turnaround time for environmental sample analysis from 45 days (at a central commercial laboratory) to 1 day. At the same time each RTAL system will save the DOE over $12 million per year in sample analysis costs compared to the costs at a central commercial laboratory. If RTAL systems were used at the eight largest DOE facilities (at Hanford, Savannah River, Fernald, Oak Ridge, Idaho, Rocky Flats, Los Alamos, and the Nevada Test Site), the annual savings would be $96,589,000. The DOE's internal study of sample analysis needs projects 130,000 environmental samples requiring analysis in FY 1994, clearly supporting the need for the RTAL system. The cost and time savings achievable with the RTAL system will accelerate and improve the efficiency of cleanup and remediation operations throughout the DOE complex

  12. The Defense Department’s Enduring Contributions to Global Health. The Future of the U.S. Army and Navy Overseas Medical Laboratories (United States)


    Drug Resistance Laboratories 1520-1600 Kombewa Clinical Research Center (CRC) - Tour and Clinical Trials Program Brief LTC Louis Macareo and Agnes “ Mama ...can lead to AIDS, in which the body’s compromised immune system makes it more susceptible to the development of infections and cancers . For this reason

  13. EPIC Trial: education programme impact on serum phosphorous control in CKD 5D patients on hemodialysis

    Directory of Open Access Journals (Sweden)

    Carmen Tzanno Branco Martins

    Full Text Available Abstract Introduction: In stage 5D chronic kidney disease (CKD 5D patients, the encouragement of treatment adherence by health professionals is a significant clinical challenge. Objectives: This study evaluates the impact of a nutritional education programme on hyperphosphatemia, utilizing the transtheoretical model of behavior change (TMBC. Subjects and Methods: A prospective interventional study comprising 179 CKD 5D patients with hypophosphatemia. The 4-month educational programme took place during dialysis sessions. Demographic and laboratory data were evaluated, whilst the TMBC was utilized both pre- and post-intervention. Results: 132 patients showed a positive change and significant reduction in phosphate levels, whilst 47 patients showed a negative change and little reduction in phosphate levels. Positive changes were identified at different levels of literacy. 117/179 participants had ongoing treatment with sevelamer throughout the trial period. 61 patients with intact parathyroid hormone (iPTH 300 pg/ml also showed a decrease in phosphate levels. Conclusions: Nutritional education programmes can achieve excellent results when appropriately applied. An education programme may be effective across different literacy levels.

  14. Systematic reviews: I. The correlation between laboratory tests on marginal quality and bond strength. II. The correlation between marginal quality and clinical outcome. (United States)

    Heintze, Siegward D


    An accepted principle in restorative dentistry states that restorations should be placed with the best marginal quality possible to avoid postoperative sensitivity, marginal discoloration, and secondary caries. Different laboratory methods claim to predict the clinical performance of restorative materials, for example, tests of bond strength and microleakage and gap analysis. The purpose of this review was twofold: (1) find studies that correlated the results of bond strength tests with either microleakage or gap analysis for the same materials, and (2) find studies that correlated the results of microleakage and/or gaps with the clinical parameters for the same materials. Furthermore, influencing factors on the results of the laboratory tests were reviewed and assessed. For the first question, searches for studies were conducted in the MEDLINE database and IADR/AADR abtracts online with specific search and inclusion criteria. The outcome for each study was assessed on the basis of the statistical test applied in the study, and finally the number of studies with or without correlation was compiled. For the second question, results of the quantitative marginal analysis of Class V restorations published by the University of Zürich with the same test protocol and prospective clinical trials were searched that investigated the same materials for at least 2 years in Class V cavities. Pearson correlation coefficients were calculated for pooled data of materials and clinical outcome parameters such as retention loss, marginal discoloration, marginal integrity, and secondary caries. For the correlation of dye penetration and clinical outcome, studies on Class V restorations published by the same research institute were searched in MEDLINE that examined the same adhesive systems as the selected clinical trials. For the correlation bond strength/microleakage, 30 studies were included into the review, and for the correlation bond strength/gap analysis 18 studies. For both

  15. The Cost-Effective Laboratory: Implementation of Economic Evaluation of Laboratory Testing

    Directory of Open Access Journals (Sweden)

    Bogavac-Stanojevic Natasa


    Full Text Available Laboratory testing as a part of laboratory in vitro diagnostic (IVD has become required tool in clinical practice for diagnosing, monitoring and prognosis of diseases, as well as for prediction of treatment response. The number of IVD tests available in laboratory practice has increased over the past decades and is likely to further increase in the future. Consequently, there is growing concern about the overutilization of laboratory tests and rising costs for laboratory testing. It is estimated that IVD accounts for between 1.4 and 2.3% of total healthcare expenditure and less than 5% of total hospital cost (Lewin Group report. These costs are rather low when compared to pharmaceuticals and medical aids which account for 15 and 5%, respectively. On the other hand, IVD tests play an important role in clinical practice, as they influence from 60% to 70% of clinical decision-making. Unfortunately, constant increases in healthcare spending are not directly related to healthcare benefit. Since healthcare resources are limited, health payers are interested whether the benefits of IVD tests are actually worth their cost. Many articles have introduced frameworks to assess the economic value of IVD tests. The most appropriate tool for quantitative assessment of their economic value is cost-effectiveness (CEA and cost-utility (CUA analysis. The both analysis determine cost in terms of effectiveness or utilities (combine quantity and quality of life of new laboratory test against its alternative. On the other hand, some investigators recommended calculation of laboratory test value as product of two ratios: Laboratory test value = (Technical accuracy/Turnaround time × (Utility/Costs. Recently, some researches used multicriteria decision analysis which allows comparison of diagnostic strategies in terms of benefits, opportunities, costs and risks. All analyses are constructed to identify laboratory test that produce the greatest healthcare benefit with

  16. Virtual Laboratory "vs." Traditional Laboratory: Which Is More Effective for Teaching Electrochemistry? (United States)

    Hawkins, Ian; Phelps, Amy J.


    The use of virtual laboratories has become an increasing issue regarding science laboratories due to the increasing cost of hands-on laboratories, and the increase in distance education. Recent studies have looked at the use of virtual tools for laboratory to be used as supplements to the regular hands-on laboratories but many virtual tools have…


    Directory of Open Access Journals (Sweden)



    Full Text Available Alien crayfishes represent a common threat to aquatic ecosystems. Their spread in Europe is leading to more frequent contacts between different invasive species populations. Shelter can be an important factor in the resulting interactions. A laboratory experiment was designed to analyse the competition for shelter in similarly sized males of two species that show an invasive behaviour in Spain, Pacifastacus leniusculus and Procambarus clarkii. We carried out 24 heterospecific, six-hour trials, with 30 min behavioural observations per hour. Most often, red swamp crayfish were both the first (70.8% and the long-term winner (62.5%. Usually, the long-term winner was the first winner. Whenever shelter was occupied, a passive behaviour by unsheltered individuals was more frequent in signal crayfish than in red swamp crayfish. When both were unsheltered, signal crayfish displayed more often a passive behaviour. Although the observed behaviour might be explained as the result of dominance by the red swamp crayfish over the signal crayfish, shelter availability and class, as well as different growth patterns and population size structures, could change the intensity and the outcome of the encounters in the wild, where signal crayfish usually reach larger sizes than red swamp crayfish.

  18. Clinical Trials

    Medline Plus

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

  19. Calgary Laboratory Services

    Directory of Open Access Journals (Sweden)

    James R. Wright MD, PhD


    Full Text Available Calgary Laboratory Services provides global hospital and community laboratory services for Calgary and surrounding areas (population 1.4 million and global academic support for the University of Calgary Cumming School of Medicine. It developed rapidly after the Alberta Provincial Government implemented an austerity program to address rising health care costs and to address Alberta’s debt and deficit in 1994. Over roughly the next year, all hospital and community laboratory test funding within the province was put into a single budget, fee codes for fee-for-service test billing were closed, roughly 40% of the provincial laboratory budget was cut, and roughly 40% of the pathologists left the province of Alberta. In Calgary, in the face of these abrupt changes in the laboratory environment, private laboratories, publicly funded hospital laboratories and the medical school department precipitously and reluctantly merged in 1996. The origin of Calgary Laboratory Services was likened to an “unhappy shotgun marriage” by all parties. Although such a structure could save money by eliminating duplicated services and excess capacity and could provide excellent city-wide clinical service by increasing standardization, it was less clear whether it could provide strong academic support for a medical school. Over the past decade, iterations of the Calgary Laboratory Services model have been implemented or are being considered in other Canadian jurisdictions. This case study analyzes the evolution of Calgary Laboratory Services, provides a metric-based review of academic performance over time, and demonstrates that this model, essentially arising as an unplanned experiment, has merit within a Canadian health care context.

  20. Gun Dynamics Laboratory (United States)

    Federal Laboratory Consortium — The Gun Dynamics Laboratory is a research multi-task facility, which includes two firing bays, a high bay area and a second floor laboratory space. The high bay area...

  1. Computational Laboratory (United States)

    Federal Laboratory Consortium — This laboratory contains a number of commercial off-the-shelf and in-house software packages allowing for both statistical analysis as well as mathematical modeling...

  2. Laboratory hemostasis: milestones in Clinical Chemistry and Laboratory Medicine. (United States)

    Lippi, Giuseppe; Favaloro, Emmanuel J


    Hemostasis is a delicate, dynamic and intricate system, in which pro- and anti-coagulant forces cooperate for either maintaining blood fluidity under normal conditions, or else will prompt blood clot generation to limit the bleeding when the integrity of blood vessels is jeopardized. Excessive prevalence of anticoagulant forces leads to hemorrhage, whereas excessive activation of procoagulant forces triggers excessive coagulation and thrombosis. The hemostasis laboratory performs a variety of first, second and third line tests, and plays a pivotal role in diagnostic and monitoring of most hemostasis disturbances. Since the leading targets of Clinical Chemistry and Laboratory Medicine include promotion of progress in fundamental and applied research, along with publication of guidelines and recommendations in laboratory diagnostics, this journal is an ideal source of information on current developments in the laboratory technology of hemostasis, and this article is aimed to celebrate some of the most important and popular articles ever published by the journal in the filed of laboratory hemostasis.

  3. Mobile-Based Video Learning Outcomes in Clinical Nursing Skill Education: A Randomized Controlled Trial. (United States)

    Lee, Nam-Ju; Chae, Sun-Mi; Kim, Haejin; Lee, Ji-Hye; Min, Hyojin Jennifer; Park, Da-Eun


    Mobile devices are a regular part of daily life among the younger generations. Thus, now is the time to apply mobile device use to nursing education. The purpose of this study was to identify the effects of a mobile-based video clip on learning motivation, competence, and class satisfaction in nursing students using a randomized controlled trial with a pretest and posttest design. A total of 71 nursing students participated in this study: 36 in the intervention group and 35 in the control group. A video clip of how to perform a urinary catheterization was developed, and the intervention group was able to download it to their own mobile devices for unlimited viewing throughout 1 week. All of the students participated in a practice laboratory to learn urinary catheterization and were blindly tested for their performance skills after participation in the laboratory. The intervention group showed significantly higher levels of learning motivation and class satisfaction than did the control. Of the fundamental nursing competencies, the intervention group was more confident in practicing catheterization than their counterparts. Our findings suggest that video clips using mobile devices are useful tools that educate student nurses on relevant clinical skills and improve learning outcomes.

  4. Physical activity and trial-by-trial adjustments of response conflict. (United States)

    Kamijo, Keita; Takeda, Yuji


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

  5. Effect of individually tailored biopsychosocial workplace interventions on chronic musculoskeletal pain and stress among laboratory technicians

    DEFF Research Database (Denmark)

    Andersen, Kenneth Jay; Brandt, Mikkel; Hansen, Klaus


    pain using individually tailored physical and cognitive elements. STUDY DESIGN: This trial uses a single-blind randomized controlled design with allocation concealment in a 2-armed parallel group format among laboratory technicians. The trial "Implementation of physical exercise at the Workplace (IRMA...... 2014 (follow-up). METHODS: Participants (n = 112) were allocated to receive either physical, cognitive, and mindfulness group-based training (PCMT group) or a reference group (REF) for 10 weeks at the worksite. PCMT consisted of 4 major elements: 1) resistance training individually tailored to the pain...... affected area, 2) motor control training, 3) mindfulness, and 4) cognitive and behavioral therapy/education. Participants of the REF group were encouraged to follow ongoing company health initiatives. The predefined primary outcome measure was pain intensity (VAS scale 0 - 10) in average of the regions...

  6. Clinical trials in dentistry in India: Analysis from trial registry. (United States)

    Gowri, S; Kannan, Sridharan


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

  7. Increasing the Signal to Noise Ratio in a Chemistry Laboratory ...

    African Journals Online (AJOL)

    Increasing the Signal to Noise Ratio in a Chemistry Laboratory - Improving a Practical for Academic Development Students. ... Analysis of data collected in 2001 shows that the changes made a significant impact on the effectiveness of the laboratory session. South African Journal of Chemistry Vol.56 2003: 47-53 ...

  8. An overview of Quality Management System implementation in a research laboratory (United States)

    Molinéro-Demilly, Valérie; Charki, Abdérafi; Jeoffrion, Christine; Lyonnet, Barbara; O'Brien, Steve; Martin, Luc


    The aim of this paper is to show the advantages of implementing a Quality Management System (QMS) in a research laboratory in order to improve the management of risks specific to research programmes and to increase the reliability of results. This paper also presents experience gained from feedback following the implementation of the Quality process in a research laboratory at INRA, the French National Institute for Agronomic Research and details the various challenges encountered and solutions proposed to help achieve smoother adoption of a QMS process. The 7Ms (Management, Measurement, Manpower, Methods, Materials, Machinery, Mother-nature) methodology based on the Ishikawa `Fishbone' diagram is used to show the effectiveness of the actions considered by a QMS, which involve both the organization and the activities of the laboratory. Practical examples illustrate the benefits and improvements observed in the laboratory.

  9. Geomechanics Laboratory (United States)

    Federal Laboratory Consortium — The Geomechanics Laboratory allows its users to measure rock properties under a wide range of simulated service conditions up to very high pressures and complex load...

  10. Saxton Transportation Operations Laboratory (United States)

    Federal Laboratory Consortium — The Saxton Transportation Operations Laboratory (Saxton Laboratory) is a state-of-the-art facility for conducting transportation operations research. The laboratory...

  11. Nonanalytic Laboratory Automation: A Quarter Century of Progress. (United States)

    Hawker, Charles D


    Clinical laboratory automation has blossomed since the 1989 AACC meeting, at which Dr. Masahide Sasaki first showed a western audience what his laboratory had implemented. Many diagnostics and other vendors are now offering a variety of automated options for laboratories of all sizes. Replacing manual processing and handling procedures with automation was embraced by the laboratory community because of the obvious benefits of labor savings and improvement in turnaround time and quality. Automation was also embraced by the diagnostics vendors who saw automation as a means of incorporating the analyzers purchased by their customers into larger systems in which the benefits of automation were integrated to the analyzers.This report reviews the options that are available to laboratory customers. These options include so called task-targeted automation-modules that range from single function devices that automate single tasks (e.g., decapping or aliquoting) to multifunction workstations that incorporate several of the functions of a laboratory sample processing department. The options also include total laboratory automation systems that use conveyors to link sample processing functions to analyzers and often include postanalytical features such as refrigerated storage and sample retrieval.Most importantly, this report reviews a recommended process for evaluating the need for new automation and for identifying the specific requirements of a laboratory and developing solutions that can meet those requirements. The report also discusses some of the practical considerations facing a laboratory in a new implementation and reviews the concept of machine vision to replace human inspections. © 2017 American Association for Clinical Chemistry.

  12. Analysis of classical time-trial performance and technique-specific physiological determinants in elite female cross-country skiers

    Directory of Open Access Journals (Sweden)

    Øyvind Sandbakk


    Full Text Available The present study investigated the contribution of performance on uphill, flat, and downhill sections to overall performance in an international 10-km classical time-trial in elite female cross-country skiers, as well as the relationships between performance on snow and laboratory-measured physiological variables in the double poling (DP and diagonal (DIA techniques. Ten elite female cross-country skiers were continuously measured by a global positioning system device during an international 10-km cross-country skiing time-trial in the classical technique. One month prior to the race, all skiers performed a 5-min submaximal and 3-min self-paced performance test while roller skiing on a treadmill, both in the DP and DIA techniques. The time spent on uphill (r=0.98 and flat (r=0.91 sections of the race correlated most strongly with the overall 10-km performance (both p<0.05. Approximately 56% of the racing time was spent uphill, and stepwise multiple regression revealed that uphill time explained 95.5% of the variance in overall performance (p<0.001. Distance covered during the 3-min roller-skiing test and body-mass normalized peak oxygen uptake (VO2peak in both techniques showed the strongest correlations with overall time-trial performance (r=0.66-0.78, with DP capacity tending to have greatest impact on the flat and DIA capacity on uphill terrain (all p<0.05. Our present findings reveal that the time spent uphill most strongly determine classical time-trial performance, and that the major portion of the performance differences among elite female cross-country skiers can be explained by variations in technique-specific aerobic power.

  13. Quality assurance trials for Ki67 assessment in pathology. (United States)

    Raap, M; Ließem, S; Rüschoff, J; Fisseler-Eckhoff, A; Reiner, A; Dirnhofer, S; von Wasielewski, R; Kreipe, H


    Ki67 is a broadly used proliferation marker in surgical pathology with an obvious need for standardization to improve reproducibility of assessment. Here, we present results of the so far only existing round robin tests on Ki67, organized annually in Germany, Austria, and Switzerland from 2010 to 2015 with up to 160 participating laboratories (QuIP). In each quality assessment trial, eight probes from each breast cancer, neuroendocrine tumor, and malignant lymphoma were compiled on a tissue microarray (TMA). TMAs were stained in the participants' laboratories with antibodies and procedures also applied in their daily routine. Participating pathologists were expected to assign Ki67 values to one of four different categories for each tumor type. All local stainings and evaluations were reassessed by the organizing panel and compared to a preset standard. On average, 95% of participants reached the benchmark of over 80% concordance rates with the Ki67 category pre-established by the panel. Automatization and type of antibody did not affect the success rate. Concordance rates differed between tumor entities being highest in each tumor type with either very high or very low labeling indices. Lower rates were seen for intermediate Ki67 levels. Staining quality improved during the observation period as did inter-observer concordance with 85% of participants achieving excellent agreement (kappa > 0.8) in the first year and over 95% in 2015. In conclusion, regular external quality assurance trials have been established as a tool to improve the reproducibility and reliability of the prognostic and predictive proliferation marker Ki67.

  14. Certification of biological reference materials: participation of the Neutron Activation Laboratory (LAN-IPEN/CNEN-SP)

    International Nuclear Information System (INIS)

    Ticianelli, Regina B.; Figueiredo, Ana Maria G.


    Analytical laboratories have as one of their important goals to demonstrate their competence allowing international acceptance and comparison of analytical data. The IPEN Neutron Activation Laboratory (LAN-IPEN) has implemented its Quality Assurance Program which comprises, among other activities, the participation in intercomparison runs. As a part of this Quality Assurance Program, LAN-IPEN has participated in interlaboratorial trials to analyze two biological candidate reference materials: INCT-CF-3 Corn Flour and INCT-SBF-4 Soya Bean Flour from the Institute of Nuclear Chemistry And Technology (Warszawa, Poland). The elements Br, Ca, Co, Cs, Fe, K, Na, Rb and Zn were analyzed in the candidate reference materials by instrumental neutron activation analysis (INAA). The performance of the laboratory was statistically evaluated in relation to the consensus values for these materials using the Z-Score test. This laboratory evaluation method has been accepted as a standard by ISO/IUPAC. In the present study, adequate Z-Score values (|Z|<2) were observed for all of the analyzed elements, confirming the accuracy of the nuclear methodology employed. The contribution of LAN-IPEN in the certification of the reference materials analyzed was very important, since the results provided were used in the statistical evaluation of the certified value. (author)

  15. Role of a quality management system in improving patient safety - laboratory aspects. (United States)

    Allen, Lynn C


    The aim of this study is to describe how implementation of a quality management system (QMS) based on ISO 15189 enhances patient safety. A literature review showed that several European hospitals implemented a QMS based on ISO 9001 and assessed the impact on patient safety. An Internet search showed that problems affecting patient safety have occurred in a number of laboratories across Canada. The requirements of a QMS based on ISO 15189 are outlined, and the impact of the implementation of each requirement on patient safety is summarized. The Quality Management Program - Laboratory Services in Ontario is briefly described, and the experience of Ontario laboratories with Ontario Laboratory Accreditation, based on ISO 15189, is outlined. Several hospitals that implemented ISO 9001 reported either a positive impact or no impact on patient safety. Patient safety problems in Canadian laboratories are described. Implementation of each requirement of the QMS can be seen to have a positive effect on patient safety. Average laboratory conformance on Ontario Laboratory Accreditation is very high, and laboratories must address and resolve any nonconformities. Other standards, practices, and quality requirements may also contribute to patient safety. Implementation of a QMS based on ISO 15189 provides a solid foundation for quality in the laboratory and enhances patient safety. It helps to prevent patient safety issues; when such issues do occur, effective processes are in place for investigation and resolution. Patient safety problems in Canadian laboratories might have been prevented had effective QMSs been in place. Ontario Laboratory Accreditation has had a positive impact on quality in Ontario laboratories. Copyright © 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  16. [Future roles of clinical laboratories and clinical laboratory technologists in university hospitals]. (United States)

    Yokota, Hiromitsu; Yatomi, Yutaka


    Clinical laboratories in university hospitals should be operated with a good balance of medical practice, education, research, and management. The role of a clinical laboratory is to promptly provide highly reliable laboratory data to satisfy the needs of clinicians involved in medical practice and health maintenance of patients. Improvement and maintenance of the quality of the laboratory staff and environment are essential to achieve this goal. In order to implement these requirements efficiently, an appropriate quality management system should be introduced and established, and evaluated objectively by a third party (e.g. by obtaining ISO 15189 certification). ISO 15189 is an international standard regarding the quality and competence of clinical laboratories, and specifies a review of the efficient operational system and technical requirements such as competence in implementing practical tests and calibration. This means the results of laboratory tests reported by accredited laboratories withstand any international evaluation, which is very important to assure the future importance of the existence and management of clinical laboratories as well as internationalization of medical practice. "Education" and "research" have important implications in addition to "medical practice" and "management", as the roles that clinical laboratories should play in university hospitals. University hospital laboratories should be operated by keeping these four factors in good balance. Why are "education" and "research" required in addition to "medical practice" services? If individual clinical laboratory technologists can provide an appropriate response to this question, the importance of the existence of clinical laboratories would be reinforced, without being compromised.

  17. Laboratory Information System – Where are we Today?

    Directory of Open Access Journals (Sweden)

    Lukić Vera


    Full Text Available Wider implementation of laboratory information systems (LIS in clinical laboratories in Serbia has been initiated ten years ago. The first LIS in the Railway Health Care Institute has been implemented nine years ago. Before the LIS was initiated, manual admission procedures limited daily output of patients. Moreover, manual entering of patients data and ordering tests on analyzers was problematic and time consuming. After completing tests, laboratory personnel had to write results in patient register (with potential errors and provide invoices for health insurance organisation. First LIS brought forward some advantages with regards to these obstacles, but it also showed various weaknesses. These can be summarised in rigidity of system and inability to fulfil user expectation. After 4 years of use, we replaced this system with another LIS. Hence, the main aim of this paper is to evaluate advant ages of using LIS in laboratory of the Railway Health Care Institute and also to discuss further possibilities for its application. After implementing LIS, admission procedure has proven to be much faster. LIS enabled electronic requests, barcoded specimens prevent identification errors, bidirectional interface replaces redundant data entry steps, QC data are transferred automatically, results are electronically validated and automatically archived in data base, billing information is transferred electronically, and more. We also use some advanced options, like delta check, HIL feature, quality indicators and various types of reports. All steps in total testing process are drastically improved after the implementation of LIS, which had a positive impact on the quality of issued laboratory results. However, we expect development of some new features in the future, for example auto-verification and inventory management. On the example of the laboratory of the Railway Health Care Institute, we show that it is crucial that laboratory specialists have the main

  18. Reading Aloud: Does Previous Trial History Modulate the Joint Effects of Stimulus Quality and Word Frequency? (United States)

    O'Malley, Shannon; Besner, Derek


    No one would argue with the proposition that how we process events in the world is strongly affected by our experience. Nonetheless, recent experience (e.g., from the previous trial) is typically not considered in the analysis of timed cognitive performance in the laboratory. Masson and Kliegl (2013) reported that, in the context of the lexical…

  19. Recruitment to publicly funded trials--are surgical trials really different? (United States)

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


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

  20. Contextual information management: An example of independent-checking in the review of laboratory-based bloodstain pattern analysis. (United States)

    Osborne, Nikola K P; Taylor, Michael C


    This article describes a New Zealand forensic agency's contextual information management protocol for bloodstain pattern evidence examined in the laboratory. In an effort to create a protocol that would have minimal impact on current work-flow, while still effectively removing task-irrelevant contextual information, the protocol was designed following an in-depth consultation with management and forensic staff. The resulting design was for a protocol of independent-checking (i.e. blind peer-review) where the checker's interpretation of the evidence is conducted in the absence of case information and the original examiner's notes or interpretation(s). At the conclusion of a ten-case trial period, there was widespread agreement that the protocol had minimal impact on the number of people required, the cost, or the time to complete an item examination. The agency is now looking to adopt the protocol into standard operating procedures and in some cases the protocol has been extended to cover other laboratory-based examinations (e.g. fabric damage, shoeprint examination, and physical fits). The protocol developed during this trial provides a useful example for agencies seeking to adopt contextual information management into their workflow. Copyright © 2018 The Chartered Society of Forensic Sciences. Published by Elsevier B.V. All rights reserved.

  1. The Relationships between University Students' Chemistry Laboratory Anxiety, Attitudes, and Self-Efficacy Beliefs (United States)

    Kurbanoglu, N. Izzet; Akin, Ahmet


    The aim of this study is to examine the relationships between chemistry laboratory anxiety, chemistry attitudes, and self-efficacy. Participants were 395 university students. Participants completed the Chemistry Laboratory Anxiety Scale, the Chemistry Attitudes Scale, and the Self-efficacy Scale. Results showed that chemistry laboratory anxiety…

  2. Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial. (United States)

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


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

  3. Safety in laboratories: Indian scenario. (United States)

    Mustafa, Ajaz; Farooq, A Jan; Qadri, Gj; S A, Tabish


    Health and safety in clinical laboratories is becoming an increasingly important subject as a result of emergence of highly infectious diseases such as Hepatitis and HIV. A cross sectional study was carried out to study the safety measures being adopted in clinical laboratories of India. Heads of laboratories of teaching hospitals of India were subjected to a standardized, pretested questionnaire. Response rate was 44.8%. only 60% of laboratories had person in-charge of safety in laboratory. Seventy three percent of laboratories had safety education program regarding hazards. In 91% of laboratories staff is using protective clothing while working in laboratories. Hazardous material regulations are followed in 78% of laboratories. Regular health check ups are carried among laboratory staff in 43.4% of laboratories.Safety manual is available in 56.5% of laboratories. 73.9% of laboratories are equipped with fire extinguishers. Fume cupboards are provided in 34.7% of laboratories and they are regularly checked in 87.5% of these laboratories. In 78.26% of laboratories suitable measures are taken to minimize formation of aerosols.In 95.6% of laboratories waste is disposed off as per bio-medical waste management handling rules. Laboratory of one private medical college was accredited with NABL and safety parameters were better in that laboratory. Installing safety engineered devices apparently contributes to significant decrease in injuries in laboratories; laboratory safety has to be a part of overall quality assurance programme in hospitals. Accreditation has to be made necessary for all laboratories.

  4. Current studies and future perspectives of synchrotron radiation imaging trials in human patients

    Energy Technology Data Exchange (ETDEWEB)

    Longo, Renata, E-mail: [Department of Physics, University of Trieste, via Valerio 2 3410 Trieste (Italy); INFN- sezione di Trieste, via Valerio 2 3410 Trieste (Italy)


    The coherent and monochromatic x-ray beams available at the synchrotron radiation (SR) laboratories are ideal tools for the development and the initial application of new imaging techniques. In the present paper the history of the clinical studies in k-edge subtraction imaging with SR is summarized, including coronary angiography and bronchography. The results of the recent trial in phase-contrast mammography at Elettra (Trieste, Italy) are discussed, in order to assess the clinical impact of the new imaging modality and the potential interest in its translation to clinical practice. The direct measurement of linear attenuation coefficient obtained during the SR mammography trial is also discussed. The new program of phase-contrast breast CT under development at Elettra is presented. Recently, 3D breast imaging (tomosynthesis and cone beam breast CT) has been introduced in clinical practice with significant improvement in diagnostic accuracy. The aim of this research is to study the contribution of the phase-contrast to the image quality of breast CT. Increasing the image quality of the x-ray medical images at the level of the results obtained at the SR laboratories is highly desirable, hence the promising techniques for the translation of the phase-contrast imaging to the hospitals are briefly discussed.

  5. Current studies and future perspectives of synchrotron radiation imaging trials in human patients

    International Nuclear Information System (INIS)

    Longo, Renata


    The coherent and monochromatic x-ray beams available at the synchrotron radiation (SR) laboratories are ideal tools for the development and the initial application of new imaging techniques. In the present paper the history of the clinical studies in k-edge subtraction imaging with SR is summarized, including coronary angiography and bronchography. The results of the recent trial in phase-contrast mammography at Elettra (Trieste, Italy) are discussed, in order to assess the clinical impact of the new imaging modality and the potential interest in its translation to clinical practice. The direct measurement of linear attenuation coefficient obtained during the SR mammography trial is also discussed. The new program of phase-contrast breast CT under development at Elettra is presented. Recently, 3D breast imaging (tomosynthesis and cone beam breast CT) has been introduced in clinical practice with significant improvement in diagnostic accuracy. The aim of this research is to study the contribution of the phase-contrast to the image quality of breast CT. Increasing the image quality of the x-ray medical images at the level of the results obtained at the SR laboratories is highly desirable, hence the promising techniques for the translation of the phase-contrast imaging to the hospitals are briefly discussed.

  6. National laboratories

    International Nuclear Information System (INIS)

    Moscati, G.


    The foundation of a 'National Laboratory' which would support a Research center in synchrotron radiation applications is proposed. The essential features of such a laboratory differing of others centers in Brazil are presented. (L.C.) [pt

  7. Policies and practices in haemostasis testing among laboratories in Croatia: a survey on behalf of a Working Group for Laboratory Coagulation of the Croatian Society of Medical Biochemistry and Laboratory Medicine. (United States)

    Bronić, Ana; Herak, Desiree Coen; Margetić, Sandra; Milić, Marija


    The objective of this survey was to assess current policies and practice in haemostasis testing among both hospital and outpatient laboratories in Republic of Croatia. A questionnaire with seventy questions divided into nine sections was created in May 2015. Participants were asked about their practice related to test request form, sample collection, prothrombin time (PT) and activated partial thromboplastin time assays, other individual haemostasis assays, point-of-care testing (POCT), reporting of coagulation tests results and quality assurance of procedures, the personnel and other laboratory resources, as well as on issues related to education and implementation of additional coagulation assays in their laboratory. The survey was administered and data were collected between June and September 2015. A total survey response rate was 104/170 (61.2%). Most respondents were faced with incomplete information on prescribed therapy and diagnosis on the test request or inappropriate samples withdrawn on distant locations, but also do not have protocols for handling samples with high haematocrit values. Reporting of PT-INR and D-dimer results was different between laboratories. Although almost all laboratories developed a critical value reporting system, reporting a value to general practitioners is still a problem. Result on coagulation POCT testing showed that not all devices were supervised by laboratories, which is not in compliance with Croatian Chamber of Medical Biochemistry acts. Obtained results highlighted areas that need improvement and different practice patterns in particular field of haemostasis testing among laboratories. A harmonization of the overall process of haemostasis testing at national level should be considered and undertaken.

  8. Clinical Trials

    Medline Plus

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

  9. Clinical Trials

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

  10. Clinical Trials

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

  11. Clinical Trials

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

  12. Clinical Trials

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

  13. Clinical Trials

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

  14. Clinical Trials

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

  15. Clinical Trials

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

  16. Clinical Trials

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

  17. Clinical Trials

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

  18. Clinical Trials

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

  19. Clinical Trials

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

  20. Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial. (United States)

    Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C


    The Systolic Blood Pressure Intervention Trial is a multicenter, randomized clinical trial of 9361 participants with hypertension who are ≥50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal recruitment strategies and lessons learned during recruitment of the Systolic Blood Pressure Intervention Trial cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥75 years, women, and minorities. In collaboration with the National Institutes of Health Project Office and Systolic Blood Pressure Intervention Trial Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began on 8 November 2010 and ended on 15 March 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Recruitment was scheduled to last 24 months to enroll a target of 9250 participants; in just over 28 months, the trial enrolled 9361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by Systolic Blood Pressure Intervention Trial staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, Internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized/number screened) was 64% (9361 randomized/14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those aged ≥75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional

  1. Entrainment in Laboratory Simulations of Cumulus Cloud Flows (United States)

    Narasimha, R.; Diwan, S.; Subrahmanyam, D.; Sreenivas, K. R.; Bhat, G. S.


    A variety of cumulus cloud flows, including congestus (both shallow bubble and tall tower types), mediocris and fractus have been generated in a water tank by simulating the release of latent heat in real clouds. The simulation is achieved through ohmic heating, injected volumetrically into the flow by applying suitable voltages between diametral cross-sections of starting jets and plumes of electrically conducting fluid (acidified water). Dynamical similarity between atmospheric and laboratory cloud flows is achieved by duplicating values of an appropriate non-dimensional heat release number. Velocity measurements, made by laser instrumentation, show that the Taylor entrainment coefficient generally increases just above the level of commencement of heat injection (corresponding to condensation level in the real cloud). Subsequently the coefficient reaches a maximum before declining to the very low values that characterize tall cumulus towers. The experiments also simulate the protected core of real clouds. Cumulus Congestus : Atmospheric cloud (left), simulated laboratory cloud (right). Panels below show respectively total heat injected and vertical profile of heating in the laboratory cloud.

  2. Personalized laboratory medicine

    DEFF Research Database (Denmark)

    Pazzagli, M.; Malentacchi, F.; Mancini, I.


    diagnostic tools and expertise and commands proper state-of-the-art knowledge about Personalized Medicine and Laboratory Medicine in Europe, the joint Working Group "Personalized Laboratory Medicine" of the EFLM and ESPT societies compiled and conducted the Questionnaire "Is Laboratory Medicine ready...... in "omics"; 2. Additional training for the current personnel focused on the new methodologies; 3. Incorporation in the Laboratory of new competencies in data interpretation and counselling; 4. Improving cooperation and collaboration between professionals of different disciplines to integrate information...

  3. Clinical Trials

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

  4. Cold storage effects on egg hatch in laboratory-reared Culicoides variipennis sonorensis (Diptera: Ceratopogonidae). (United States)

    Hunt, G J; Tabachnick, W J


    The effects of cold storage (5 degrees C) on the hatching rates of laboratory-reared Culicoides variipennis sonorensis eggs were examined. Mortality increased with storage time. Average maximum embryo survivorship for 4 trials was 55.0 +/- 4.2 (+/- SEM) days. Alternating daily cycles of high and then low mean hatching rates occurred and possibly were due to location differences in temperature within the temperature-controlled rearing system. During cold storage at 5 degrees C, C. v. sonorensis eggs may be kept for ca. 28 days with an anticipated hatching rate of about 50%.

  5. Effects of cognitive therapy versus interpersonal psychotherapy in patients with major depressive disorder: a systematic review of randomized clinical trials with meta-analyses and trial sequential analyses. (United States)

    Jakobsen, J C; Hansen, J L; Simonsen, S; Simonsen, E; Gluud, C


    Major depressive disorder afflicts an estimated 17% of individuals during their lifetime at tremendous suffering and cost. Cognitive therapy and interpersonal psychotherapy are treatment options, but their effects have only been limitedly compared in systematic reviews. Using Cochrane systematic review methodology we compared the benefits and harm of cognitive therapy versus interpersonal psychotherapy for major depressive disorder. Trials were identified by searching the Cochrane Library's CENTRAL, Medline via PubMed, EMBASE, Psychlit, PsycInfo, and Science Citation Index Expanded until February 2010. Continuous outcome measures were assessed by mean difference and dichotomous outcomes by odds ratio. We conducted trial sequential analysis to control for random errors. We included seven trials randomizing 741 participants. All trials had high risk of bias. Meta-analysis of the four trials reporting data at cessation of treatment on the Hamilton Rating Scale for Depression showed no significant difference between the two interventions [mean difference -1.02, 95% confidence interval (CI) -2.35 to 0.32]. Meta-analysis of the five trials reporting data at cessation of treatment on the Beck Depression Inventory showed comparable results (mean difference -1.29, 95% CI -2.73 to 0.14). Trial sequential analysis indicated that more data are needed to definitively settle the question of a differential effect. None of the included trial reported on adverse events. Randomized trials with low risk of bias and low risk of random errors are needed, although the effects of cognitive therapy and interpersonal psychotherapy do not seem to differ significantly regarding depressive symptoms. Future trials should report on adverse events.

  6. Recovery of uranium from sea water - a laboratory study

    International Nuclear Information System (INIS)

    Jayawant, D.V.; Iyer, N.S.; Koppiker, K.S.


    Sea water contains traces of uranium, but the volume of sea water being enormous, the total quantity of uranium available from the sources is very large. From time to time, claims have been made elsewhere that a breakthrough has been made in developing a technology to recovery this uranium at an economic cost. Studies have been carried out at Uranium Extraction Division over a few years to develop a suitable technique to separate the uranium from sea water. Studies were primarily directed towards preparation of suitable inorganic ion exchangers and studying their properties. In this paper preparation of ion exchangers based on hydrous titanium oxide and the data collected in laboratory trials on their application for uranium adsorption from sea water are presented. (author). 11 refs., 2 tabs

  7. Reducing Trunk Compensation in Stroke Survivors: A Randomized Crossover Trial Comparing Visual and Force Feedback Modalities. (United States)

    Valdés, Bulmaro Adolfo; Schneider, Andrea Nicole; Van der Loos, H F Machiel


    To investigate whether the compensatory trunk movements of stroke survivors observed during reaching tasks can be decreased by force and visual feedback, and to examine whether one of these feedback modalities is more efficacious than the other in reducing this compensatory tendency. Randomized crossover trial. University research laboratory. Community-dwelling older adults (N=15; 5 women; mean age, 64±11y) with hemiplegia from nontraumatic hemorrhagic or ischemic stroke (>3mo poststroke), recruited from stroke recovery groups, the research group's website, and the community. In a single session, participants received augmented feedback about their trunk compensation during a bimanual reaching task. Visual feedback (60 trials) was delivered through a computer monitor, and force feedback (60 trials) was delivered through 2 robotic devices. Primary outcome measure included change in anterior trunk displacement measured by motion tracking camera. Secondary outcomes included trunk rotation, index of curvature (measure of straightness of hands' path toward target), root mean square error of hands' movement (differences between hand position on every iteration of the program), completion time for each trial, and posttest questionnaire to evaluate users' experience and system's usability. Both visual (-45.6% [45.8 SD] change from baseline, P=.004) and force (-41.1% [46.1 SD], P=.004) feedback were effective in reducing trunk compensation. Scores on secondary outcome measures did not improve with either feedback modality. Neither feedback condition was superior. Visual and force feedback show promise as 2 modalities that could be used to decrease trunk compensation in stroke survivors during reaching tasks. It remains to be established which one of these 2 feedback modalities is more efficacious than the other as a cue to reduce compensatory trunk movement. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  8. Integrated management system best practices in radioecological laboratories

    International Nuclear Information System (INIS)

    Carvalho, Claudia Aparecida Zerbinatti de


    The research aims to study the best practices to support a conceptual proposal for IMS - Integrated Management System (quality, environment, safety and health) applicable to Radioecology laboratories. The research design is organized into the following steps: in a first step, it was developed the bibliographic and documentary research in IMS, survey and study of standards (QMS ISO 9000 (2005), ISO 9001 (2008), ISO 9004 (2000), EMS ISO 14001 (2004) and OHSMS OHSAS 18001 (2007) and OHSAS 18002 (2008)), identification and characterization of processes in Radioecology Laboratories and study of best practices methodology and benchmarking; in the second stage of the research it was developed a case study (qualitative research, with questionnaires via e-mail and interviews, when possible), preceded by a survey and selection of international and national radioecology laboratories and then these laboratories were contacted and some of them agreed to participate in this research; in the third stage of the research it was built the framework of best practices that showed results that could support the conceptual proposal for the IMS Radioecology Laboratory; the fourth and final stage of research consisted in the construction of the proposed conceptual framework of SGI for Radioecology Laboratory, being then achieved the initial objective of the research. (author)

  9. Modular laboratories--cost-effective and sustainable infrastructure for resource-limited settings. (United States)

    Bridges, Daniel J; Colborn, James; Chan, Adeline S T; Winters, Anna M; Dengala, Dereje; Fornadel, Christen M; Kosloff, Barry


    High-quality laboratory space to support basic science, clinical research projects, or health services is often severely lacking in the developing world. Moreover, the construction of suitable facilities using traditional methods is time-consuming, expensive, and challenging to implement. Three real world examples showing how shipping containers can be converted into modern laboratories are highlighted. These include use as an insectary, a molecular laboratory, and a BSL-3 containment laboratory. These modular conversions have a number of advantages over brick and mortar construction and provide a cost-effective and timely solution to offer high-quality, user-friendly laboratory space applicable within the developing world. © The American Society of Tropical Medicine and Hygiene.

  10. MRI of Mouse Models for Gliomas Shows Similarities to Humans and Can Be Used to Identify Mice for Preclinical Trials

    Directory of Open Access Journals (Sweden)

    Jason A. Koutcher


    Full Text Available Magnetic resonance imaging (MRI has been utilized for screening and detecting brain tumors in mice based upon their imaging characteristics appearance and their pattern of enhancement. Imaging of these tumors reveals many similarities to those observed in humans with identical pathology. Specifically, high-grade murine gliomas have histologic characteristics of glioblastoma multiforme (GBM with contrast enhancement after intravenous administration of gadolinium diethylenetriamine pentaacetic acid (Gd-DTPA, implying disruption of the blood-brain barrier in these tumors. In contrast, low-grade murine oligodendrogliomas do not reveal contrast enhancement, similar to human tumors. MRI can be used to identify mice with brain neoplasms as inclusion criteria in preclinical trials.

  11. Laboratory EXAFS using photographic method

    Energy Technology Data Exchange (ETDEWEB)

    Joshi, S K [Government College, Badnawar (Dhar)-454660 (India); Gaur, A; Johari, A; Shrivastava, B D, E-mail: [School of Studies in Physics, Vikram University, Ujjain-456010 (India)


    Laboratory EXAFS facilities have been used since long. However, EXAFS data analysis has not been reported as yet for the spectra recorded photographically. Though from our laboratory we have been reporting various studies employing X-ray spectrographs using the photographic method of registration of EXAFS spectra, but the data has never been analyzed using the Fourier transformation method and fitting with standards. This paper reports the study of copper metal EXAFS spectra at the K-edge recorded photographically employing a 400 mm curved mica crystal Cauchois type spectrograph with 0.5 kW tungsten target X-ray tube. The data obtained in digital form with the help of a microphotometer has been processed using EXAFS data analysis programs Athena and Artemis. The experimental data for copper metal foil have been fitted with the theoretical standards. The results have been compared with those obtained from another laboratory EXAFS set up employing 12 kW Rigaku rotating anode, Johansson-type spectrometer with Si(311) monochromator crystal and scintillation counter. The results have also been compared with those obtained from SSRL. The parameters obtained for the first two shells from the photographic method are comparable with those obtained from the other two methods. The present work shows that the photographic method of registering EXAFS spectra in laboratory set up using fixed target X-ray tubes can also be used for getting structural information at least for the first two coordination shells.

  12. Laboratory EXAFS using photographic method

    International Nuclear Information System (INIS)

    Joshi, S K; Gaur, A; Johari, A; Shrivastava, B D


    Laboratory EXAFS facilities have been used since long. However, EXAFS data analysis has not been reported as yet for the spectra recorded photographically. Though from our laboratory we have been reporting various studies employing X-ray spectrographs using the photographic method of registration of EXAFS spectra, but the data has never been analyzed using the Fourier transformation method and fitting with standards. This paper reports the study of copper metal EXAFS spectra at the K-edge recorded photographically employing a 400 mm curved mica crystal Cauchois type spectrograph with 0.5 kW tungsten target X-ray tube. The data obtained in digital form with the help of a microphotometer has been processed using EXAFS data analysis programs Athena and Artemis. The experimental data for copper metal foil have been fitted with the theoretical standards. The results have been compared with those obtained from another laboratory EXAFS set up employing 12 kW Rigaku rotating anode, Johansson-type spectrometer with Si(311) monochromator crystal and scintillation counter. The results have also been compared with those obtained from SSRL. The parameters obtained for the first two shells from the photographic method are comparable with those obtained from the other two methods. The present work shows that the photographic method of registering EXAFS spectra in laboratory set up using fixed target X-ray tubes can also be used for getting structural information at least for the first two coordination shells.

  13. Clinical Trials

    Medline Plus

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

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

    Directory of Open Access Journals (Sweden)

    Joseph S Ross


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

  15. The transitive fallacy for randomized trials: If A bests B and B bests C in separate trials, is A better than C?

    Directory of Open Access Journals (Sweden)

    Kramer Barnett S


    Full Text Available Abstract Background If intervention A bests B in one randomized trial, and B bests C in another randomized trial, can one conclude that A is better than C? The problem was motivated by the planning of a randomized trial, where A is spiral-CT screening, B is x-ray screening, and C is no screening. On its surface, this would appear to be a straightforward application of the transitive principle of logic. Methods We extended the graphical approach for omitted binary variables that was originally developed to illustrate Simpson's paradox, applying it to hypothetical, but plausible scenarios involving lung cancer screening, treatment for gastric cancer, and antibiotic therapy for clinical pneumonia. Results Graphical illustrations of the three examples show different ways the transitive fallacy for randomized trials can arise due to changes in an unobserved or unadjusted binary variable. In the most dramatic scenario, B bests C in the first trial, A bests B in the second trial, but C bests A at the time of the second trial. Conclusion Even with large sample sizes, combining results from a previous randomized trial of B versus C with results from a new randomized trial of A versus B will not guarantee correct inference about A versus C. A three-arm trial of A, B, and C would protect against this problem and should be considered when the sequential trials are performed in the context of changing secular trends in important omitted variables such as therapy in cancer screening trials.

  16. Single-trial event-related potentials to significant stimuli. (United States)

    Rushby, Jacqueline A; Barry, Robert J


    The stimulus-response pattern of the skin conductance response (SCR) was used as a model of the Orienting Reflex (OR) to assess the P1, N1, P2, N2 and late positive complex (LPC/P300) components of the ERP in a simple habituation paradigm, in which a single series of 12 innocuous tones were presented at a very long interstimulus interval (2 min). To maintain their waking state during this boring task, participants were instructed to alternately close or open their eyes to each stimulus. None of the baseline-to-peak ERP measures showed trials effects comparable with the marked habituation over trials shown by the SCRs. Principal Components Analysis was used to decompose the ERP, yielding factors identified as the N1, N2, P3a, P3b and Novelty P3 components. An additional factor represented later eye-movement activity. No trial effects were apparent for the N1, N2, P3a or P3b components. The Novelty P3 showed marked response decrement over trials. These results are discussed in relation to current conceptualisations of the OR.

  17. Case report of Salmonella cross-contamination in a food laboratory. (United States)

    Rasschaert, Geertrui; De Reu, K; Heyndrickx, M; Herman, L


    This paper describes a case of Salmonella cross-contamination in a food laboratory. In 2012, chocolate bars shipped from Belgium to the USA were prevented from entering the USA because a Salmonella Rissen strain had been isolated from one of the chocolate bars in a Belgian food laboratory. However, a retrospective study of the Salmonella isolates sent from the laboratory to the Belgian National Reference Laboratory for Salmonella revealed that 7 weeks prior, a Salmonella Rissen strain has been isolated from fish meal in the same food laboratory. The chocolate bars were not expected to be contaminated with Salmonella because the ingredients all tested negative during the production process. Furthermore, because Salmonella Rissen is only rarely isolated from food, it was hypothesized that the two Salmonella Rissen isolates belonged to the same strain and that the second isolation event in this laboratory was caused by cross-contamination. To confirm this hypothesis, both Salmonella Rissen isolates were fingerprinted using different molecular techniques. To evaluate the discriminatory power of the techniques used, 11 other Salmonella Rissen isolates from different origins were included in the comparison. Pulsed-field gel electrophoresis, repetitive element palindromic PCR and three random amplified polymorphic DNA PCR assays were used. Repetitive element palindromic PCR and random amplified polymorphic DNA PCR assays were insufficiently discriminatory, whereas pulsed-field gel electrophoresis using the combination of two restriction enzymes showed sufficient discrimination to confirm the hypothesis. Although cross-contamination in food laboratories are rarely reported, cross-contamination can always occur. Laboratories should therefore always be aware of the possibility of cross-contamination, especially when enrichment is used in the microbiological analysis. Furthermore, it is advised that results showing isolates of the same serotype isolated in a short time frame

  18. External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance. (United States)

    Murphy, Sean C; Hermsen, Cornelus C; Douglas, Alexander D; Edwards, Nick J; Petersen, Ines; Fahle, Gary A; Adams, Matthew; Berry, Andrea A; Billman, Zachary P; Gilbert, Sarah C; Laurens, Matthew B; Leroy, Odile; Lyke, Kristen E; Plowe, Christopher V; Seilie, Annette M; Strauss, Kathleen A; Teelen, Karina; Hill, Adrian V S; Sauerwein, Robert W


    Nucleic acid testing (NAT) for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA) program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide.

  19. Cross-system evaluation of clinical trial search engines. (United States)

    Jiang, Silis Y; Weng, Chunhua


    Clinical trials are fundamental to the advancement of medicine but constantly face recruitment difficulties. Various clinical trial search engines have been designed to help health consumers identify trials for which they may be eligible. Unfortunately, knowledge of the usefulness and usability of their designs remains scarce. In this study, we used mixed methods, including time-motion analysis, think-aloud protocol, and survey, to evaluate five popular clinical trial search engines with 11 users. Differences in user preferences and time spent on each system were observed and correlated with user characteristics. In general, searching for applicable trials using these systems is a cognitively demanding task. Our results show that user perceptions of these systems are multifactorial. The survey indicated eTACTS being the generally preferred system, but this finding did not persist among all mixed methods. This study confirms the value of mixed-methods for a comprehensive system evaluation. Future system designers must be aware that different users groups expect different functionalities.

  20. Environmental monitoring report: Sandia Laboratories, 1976

    International Nuclear Information System (INIS)

    Simmons, T.N.


    Water and vegetation are monitored to determine Sandia Laboratories impact on the surrounding environment. Nonradioactive pollutants released are reported. Radioactive effluents are also reported and their person-rem contribution to the Albuquerque population is calculated. The environmental monitoring for calendar year 1976 shows that concentrations of radioactive materials in the Albuquerque area are typical of natural background for the area. An exception is a single onsite location where slightly abnormal uranium concentrations are expected. An estimated 0.044 person-rem Albuquerque area (80 km radius) population dose commitment results from calculated Sandia Laboratories releases. Over the same area 57,000 person-rem is accumulated from natural background. There were no measurable offsite radioactive effluent releases in CY 1976

  1. ATLAS Canada lightpath data transfer trial

    CERN Document Server

    Kost, C J; Caron, B; Hong, W


    Emerging grids play a significant role in the computational, data, storage, and network requirements of high energy physics experiments coming online in the next few years. One such requirement, the bulk transfer of data over advanced high speed optical networks is necessary as such experiments are highly distributed with resources and participants from research laboratories and institutions spanning the globe. This trial at the iGrid 2002 conference attempts to stress the feasibility of high speed bulk data transfer over an end-to-end lightpath, a dedicated point-to-point optical link. Specifically, the objective was to transfer 1 TB of Monte Carlo data from TRIUMF in Vancouver, Canada, to CERN in Geneva, Switzerland. A rate equivalent to transferring a full CD of data every 8 s was achieved. (15 refs).

  2. Spatiotemporal dynamics of random stimuli account for trial-to-trial variability in perceptual decision making (United States)

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


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

  3. A professional development model for medical laboratory scientists working in the microbiology laboratory. (United States)

    Amerson, Megan H; Pulido, Lila; Garza, Melinda N; Ali, Faheem A; Greenhill, Brandy; Einspahr, Christopher L; Yarsa, Joseph; Sood, Pramilla K; Hu, Peter C


    The University of Texas M.D. Anderson Cancer Center, Division of Pathology and Laboratory Medicine is committed to providing the best pathology and medicine through: state-of-the art techniques, progressive ground-breaking research, education and training for the clinical diagnosis and research of cancer and related diseases. After surveying the laboratory staff and other hospital professionals, the Department administrators and Human Resource generalists developed a professional development model for Microbiology to support laboratory skills, behavior, certification, and continual education within its staff. This model sets high standards for the laboratory professionals to allow the labs to work at their fullest potential; it provides organization to training technologists based on complete laboratory needs instead of training technologists in individual areas in which more training is required if the laboratory needs them to work in other areas. This model is a working example for all microbiology based laboratories who want to set high standards and want their staff to be acknowledged for demonstrated excellence and professional development in the laboratory. The PDM model is designed to focus on the needs of the laboratory as well as the laboratory professionals.

  4. Clinical Trials

    Medline Plus

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

  5. Clinical Trials

    Medline Plus

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

  6. ANFO truck burn trials

    Energy Technology Data Exchange (ETDEWEB)

    Rosen von, B.; Contestabile, E. [Natural Resources Canada, CANMET Canadian Explosives Research Laboratory, Ottawa, ON (Canada)


    This report describes the investigation of a tractor-trailer explosion. A truck loaded with 18,000 kg of commercial explosives, of which 13,000 kg was ammonium nitrate with fuel oil (ANFO), caught fire when it struck a rockcut near Walden, Ontario on August 5, 1998. The fire resulted in the detonation of the load. The Canadian Explosives Research Laboratory (CERL) conducted a test program to examine the suitability of existing explosive transportation regulations. Unconfined burns of ANFO were performed. The accident was recreated in two burn trials in an attempt to identify the mechanism that led from fire to detonation. Two full-scale tests were conducted using complete tractor-trailers, each in a jack-knifed position with most of the explosives placed on the ground in front of the trailer. ANFO was used in the first test to determine its response to thermal stimulus and the likelihood of detonation or explosion. The second test involved ANFO, a slurry and an emulsion. Thermocouples and video cameras were used to observe the burning characteristics of the explosives, the truck and its components. The explosives burned steadily for 80 minutes in each test. Many truck components, such as tires, spring brake chambers and the fuel tank ruptured violently due to the heat. Although no detonation occurred in the test trials, it was concluded that under favourable conditions, many truck components, might produce fragments with enough energy to initiate heat-sensitized explosives. It was suggested that a fragment impact caused the detonation at Walden. 4 refs., 7 tabs., 8 figs.

  7. Managing clinical trials

    Directory of Open Access Journals (Sweden)

    Kenyon Sara


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

  8. Chemistry as the defining science: discipline and training in nineteenth-century chemical laboratories. (United States)

    Jackson, Catherine M


    The institutional revolution has become a major landmark of late-nineteenth century science, marking the rapid construction of large, institutional laboratories which transformed scientific training and practice. Although it has served historians of physics well, the institutional revolution has proved much more contentious in the case of chemistry. I use published sources, mainly written by chemists and largely focused on laboratories built in German-speaking lands between about 1865 and 1900, to show that chemical laboratory design was inextricably linked to productive practice, large-scale pedagogy and disciplinary management. I argue that effective management of the novel risks inherent in teaching and doing organic synthesis was significant in driving and shaping the construction of late-nineteenth century institutional chemical laboratories, and that these laboratories were essential to the disciplinary development of chemistry. Seen in this way, the laboratory necessarily becomes part of the material culture of late-nineteenth century chemistry, and I show how this view leads not only to a revision of what is usually known as the laboratory revolution in chemistry but also to a new interpretation of the institutional revolution in physics. Copyright © 2011 Elsevier Ltd. All rights reserved.

  9. Clinical Trials

    Medline Plus

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

  10. Characterizing the Laboratory Market

    Energy Technology Data Exchange (ETDEWEB)

    Shehabi, Arman [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Ganeshalingam, Mohan [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); DeMates, Lauren [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Mathew, Paul [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Sartor, Dale [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)


    Laboratories are estimated to be 3-5 times more energy intensive than typical office buildings and offer significant opportunities for energy use reductions. Although energy intensity varies widely, laboratories are generally energy intensive due to ventilation requirements, the research instruments used, and other health and safety concerns. Because the requirements of laboratory facilities differ so dramatically from those of other buildings, a clear need exists for an initiative exclusively targeting these facilities. The building stock of laboratories in the United States span different economic sectors, include governmental and academic institution, and are often defined differently by different groups. Information on laboratory buildings is often limited to a small subsection of the total building stock making aggregate estimates of the total U.S. laboratories and their energy use challenging. Previous estimates of U.S. laboratory space vary widely owing to differences in how laboratories are defined and categorized. A 2006 report on fume hoods provided an estimate of 150,000 laboratories populating the U.S. based in part on interviews of industry experts, however, a 2009 analysis of the 2003 Commercial Buildings Energy Consumption Survey (CBECS) generated an estimate of only 9,000 laboratory buildings. This report draws on multiple data sources that have been evaluated to construct an understanding of U.S. laboratories across different sizes and markets segments. This 2016 analysis is an update to draft reports released in October and December 2016.

  11. Testing Delays Resulting in Increased Identification Accuracy in Line-Ups and Show-Ups. (United States)

    Dekle, Dawn J.


    Investigated time delays (immediate, two-three days, one week) between viewing a staged theft and attempting an eyewitness identification. Compared lineups to one-person showups in a laboratory analogue involving 412 subjects. Results show that across all time delays, participants maintained a higher identification accuracy with the showup…

  12. The Relaxation Exercise and Social Support Trial (RESST: a community-based randomized controlled trial to alleviate medically unexplained vaginal discharge symptoms

    Directory of Open Access Journals (Sweden)

    Kobeissi Loulou


    Full Text Available Abstract Background Symptoms such as medically unexplained vaginal discharge (MUVD are common and bothersome, leading to potentially unnecessary use of resources. Methods A community-based individually randomized controlled trial to assess the effectiveness of a relatively simple, culturally appropriate multi-component intervention on reducing reported MUVD, among women suffering from low-moderate levels of common mental distress. The setting was a socio-economically deprived, informal settlement in the southern suburbs of Beirut, Lebanon. The intervention comprised up to 12 group sessions implemented over a six-week period, each divided into a psychosocial and a relaxation exercise component. The primary outcome was self-reported MUVD, which was defined as a complaint of vaginal discharge upon ruling out reproductive tract infections (RTIs, through lab analysis. Anxiety and/or depression symptoms were the secondary outcomes for this trial. These were assessed using an Arabic validated version of the Hopkins Symptoms Checklist-25 (HSCL-25. Assessments were done at baseline and six months using face-to face interviews, pelvic examinations and laboratory tests. Women were randomized into either intervention or control group. Blinding on the intervention status was not possible for both logistic and ethical reasons, especially as knowledge of involvement in the intervention was integral to its delivery. Intent to treat analysis was used. Results Of 75 women randomized to the intervention, 48% reported MUVD at 6 months compared with 63% of 73 in the control group (difference of -15%, 95% confidence interval (CI -31%, 0%, p=0.067. Adjustments for baseline imbalances and any factors relating to consent had no appreciable effect on these results. The risk of MUVD was reduced in absolute terms by 2.4% for each intervention session attended (95% CI -4.9%, 0.0%, p=0.049. While there was also marginal evidence of a beneficial effect on anxiety, there was

  13. Business analytics of specialized medical biochemistry laboratory using profit and loss acount

    Directory of Open Access Journals (Sweden)

    Vikica Buljanović


    Full Text Available Introduction. By measuring the actual effectiveness of a medical biochemistry laboratory’s business operations, we can determine the accounting measure of laboratory’s profitability, where operating expenses of the laboratory are covered by the income generated from the services. A laboratory’s financial report can be based on a profit and loss account, which shows whether or not a business entity, i.e., the laboratory, is making a profit during a particular business period. Methods. Profitability of the Specialized Medical Biochemical Laboratory (Laboratory of the General County Hospital in Našice, Croatia, was determined using the profit and loss account for 2007. Business success was expressed using the accounting measures of marginal contribution, gross income, and operating income, which could show whether or not the laboratory was operating profitably. This procedure allowed us to identify indicators of successful or unsuccessful business operations of the Laboratory. Results. According to the profit and loss account, the operating profit was 719,926 HRK, i.e., the operating margin was 11.7%, indicating that the Laboratory was operating positively. After subtracting all operating expenses per 100 income units, 11.7 units profit remained from the Laboratory’s core business. Conclusion. The Specialized Medical Biochemical Laboratory of the General County Hospital in Našice generated income, i.e., it operated at a profit. The purpose of profit and loss account was to determine the Laboratory operations that had impact on its business effectiveness and could increase the actual profitability. If the laboratory operates at a loss, and no activities are undertaken that would reverse the business toward positive, the analysis may provide information on the cost for the society as a whole of the studied laboratory within the existing healthcare system.

  14. Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial. (United States)

    Krupp, L B; Hyman, L G; Grimson, R; Coyle, P K; Melville, P; Ahnn, S; Dattwyler, R; Chandler, B


    To determine whether post Lyme syndrome (PLS) is antibiotic responsive. The authors conducted a single-center randomized double-masked placebo-controlled trial on 55 patients with Lyme disease with persistent severe fatigue at least 6 or more months after antibiotic therapy. Patients were randomly assigned to receive 28 days of IV ceftriaxone or placebo. The primary clinical outcomes were improvement in fatigue, defined by a change of 0.7 points or more on an 11-item fatigue questionnaire, and improvement in cognitive function (mental speed), defined by a change of 25% or more on a test of reaction time. The primary laboratory outcome was an experimental measure of CSF infection, outer surface protein A (OspA). Outcome data were collected at the 6-month visit. Patients assigned to ceftriaxone showed improvement in disabling fatigue compared to the placebo group (rate ratio, 3.5; 95% CI, 1.50 to 8.03; p = 0.001). No beneficial treatment effect was observed for cognitive function or the laboratory measure of persistent infection. Four patients, three of whom were on placebo, had adverse events associated with treatment, which required hospitalization. Ceftriaxone therapy in patients with PLS with severe fatigue was associated with an improvement in fatigue but not with cognitive function or an experimental laboratory measure of infection in this study. Because fatigue (a nonspecific symptom) was the only outcome that improved and because treatment was associated with adverse events, this study does not support the use of additional antibiotic therapy with parenteral ceftriaxone in post-treatment, persistently fatigued patients with PLS.

  15. Clinical Trials

    Medline Plus

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

  16. Plant Line Trial Evaluation of Viable Non-Chromium Passivation Systems for Electrolytin Tinplate, ETP (TRP 9911)

    Energy Technology Data Exchange (ETDEWEB)

    John A. Sinsel


    Plant trial evaluations have been completed for two zirconium-based, non-chromium passivation systems previously identified as possible alternatives to cathodic dichromate (CDC) passivation for electrolytic tinplate (ETP). These trials were done on a commercial electrolytic tin plating line at Weirton Steel and extensive evaluations of the materials resulting from these trials have been completed. All this was accomplished as a collaborative effort under the AISI Technology Roadmap Program and was executed by seven North American Tin Mill Products producers [Bethlehem Steel (now acquired by International Steel Group (ISG)), Dofasco Inc., National Steel (now acquired by U.S. Steel), U.S. Steel, USS-Posco, Weirton Steel, and Wheeling-Pittsburgh Steel] with funding partially from the Department of Energy (DOE) and partially on an equal cost sharing basis among project participants. The initial phases of this project involved optimization of application procedures for the non-chromium systems in the laboratories at Bethlehem Steel and Betz Dearborn followed by extensive testing with various lacquer formulations and food simulants in the laboratories at Valspar and PPG. Work was also completed at Dofasco and Weirton Steel to develop methods to prevent precipitation of insoluble solids as a function of time from the zirconate system. The results of this testing indicated that sulfide staining characteristics for the non-chromium passivation systems could be minimized but not totally eliminated and neither system was found to perform quite as good, in this respect, as the standard CDC system. As for the stability of zirconate treatment, a method was developed to stabilize this system for a sufficient period of time to conduct plant trial evaluations but, working with a major supplier of zirconium orthosulfate, a method for long term stabilization is still under development.

  17. Sandia National Laboratories (United States)

    Gilliom, Laura R.


    Sandia National Laboratories has identified technology transfer to U.S. industry as a laboratory mission which complements our national security mission and as a key component of the Laboratory's future. A number of technology transfer mechanisms - such as CRADA's, licenses, work-for-others, and consortia - are identified and specific examples are given. Sandia's experience with the Specialty Metals Processing Consortium is highlighted with a focus on the elements which have made it successful. A brief discussion of Sandia's potential interactions with NASA under the Space Exploration Initiative was included as an example of laboratory-to-NASA technology transfer. Viewgraphs are provided.

  18. Laboratory exercises to teach clinically relevant chemistry of antibiotics. (United States)

    El Sayed, Khalid A; Chelette, Candace T


    To design, implement, and evaluate student performance on clinically relevant chemical and spectral laboratory exercises on antibiotics. In the first of 2 exercises, second-year pharmacy students enrolled in an integrated laboratory sequence course studied the aqueous stability of ß-lactam antibiotics using a spectral visual approach. In a second exercise, students studied the tendency of tetracycline, rifamycins, and fluoroquinolones to form insoluble chelate complexes (turbidity) with polyvalent metals. On a survey to assess achievement of class learning objectives, students agreed the laboratory activities helped them better retain important information concerning antibiotic stability and interactions. A significant improvement was observed in performance on examination questions related to the laboratory topics for 2012 and 2013 students compared to 2011 students who did not complete the laboratory. A 1-year follow-up examination question administered in a separate course showed >75% of the students were able to identify rifamycins-food interactions compared with laboratory exercises. The use of spectral visual approaches allowed students to investigate antibiotic stability and interactions, thus reinforcing the clinical relevance of medicinal chemistry. Students' performance on questions at the 1-year follow-up suggested increased retention of the concepts learned as a result of completing the exercises.

  19. A systematic review of nonrandomized controlled trials on the curative effects of aquatic exercise

    Directory of Open Access Journals (Sweden)

    Kamioka H


    Full Text Available Hiroharu Kamioka1, Kiichiro Tsutani2, Yoshiteru Mutoh3, Hiroyasu Okuizum4, Miho Ohta5, Shuichi Handa4, Shinpei Okada6, Jun Kitayuguchi7, Masamitsu Kamada7, Nobuyoshi Shiozawa8, Sang-Jun Park4, Takuya Honda4, Shoko Moriyama41Faculty of Regional Environment Science, Tokyo University of Agriculture, Tokyo, Japan; 2Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, 3Department of Physical and Health Education, Graduate School of Education, The University of Tokyo, Tokyo, Japan; 4Mimaki Onsen (Spa Clinic, Tomi City, Japan; 5Laboratory of Aqua, Health, and Sports Medicine, 6Physical Education and Medicine Research Foundation, Nagano, Japan; 7Physical Education and Medicine Research Center Unnan, Unnan City, Japan; 8Department of Longevity and Social Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, JapanBackground: The objectives of this review were to integrate the evidence of curative effects through aquatic exercise and assess the quality of studies based on a review of nonrandomized controlled trials (nRCTs.Methods: Study design was a systematic review of nonrandomized controlled trials. Trials were eligible if they were nonrandomized clinical trials. Studies included one treatment group in which aquatic exercise was applied. We searched the following databases from 2000 up to July 20, 2009: MEDLINE via PubMed, CINAHL, and Ichushi-Web.Results: Twenty-one trials met all inclusion criteria. Languages included were English (N = 9, Japanese (N = 11, and Korean (N = 1. Target diseases were knee and/or hip osteoarthritis, poliomyelitis, chronic kidney disease, discomforts of pregnancy, cardiovascular diseases, and rotator cuff tears. Many studies on nonspecific disease (healthy participants were included. All studies reported significant effectiveness in at least one or more outcomes. However results of evaluations with the TREND and CLEAR-NPT checklists generally

  20. Comparison of the analysis result between two laboratories using different methods

    International Nuclear Information System (INIS)

    Sri Murniasih; Agus Taftazani


    Comparison of the analysis result of volcano ash sample between two laboratories using different analysis methods. The research aims to improve the testing laboratory quality and cooperate with the testing laboratory from other country. Samples were tested at the Center for Accelerator of Science and Technology (CAST)-NAA laboratory using NAA, while at the University of Texas (UT) USA using ICP-MS and ENAA method. From 12 elements of target, CAST-NAA able to present 11 elements of data analysis. The comparison results shows that the analysis of the K, Mn, Ti and Fe elements from both laboratories have a very good comparison and close one to other. It is known from RSD values and correlation coefficients of the both laboratories analysis results. While observed of the results difference known that the analysis results of Al, Na, K, Fe, V, Mn, Ti, Cr and As elements from both laboratories is not significantly different. From 11 elements were reported, only Zn which have significantly different values for both laboratories. (author)

  1. GaInSn usage in the research laboratory

    International Nuclear Information System (INIS)

    Morley, N. B.; Burris, J.; Cadwallader, L. C.; Nornberg, M. D.


    GaInSn, a eutectic alloy, has been successfully used in the Magneto-Thermofluid Research Laboratory at the University of California-Los Angeles and at the Princeton Plasma Physics Laboratory for the past six years. This paper describes the handling and safety of GaInSn based on the experience gained in these institutions, augmented by observations from other researchers in the liquid metal experimental community. GaInSn is an alloy with benign properties and shows considerable potential in liquid metal experimental research and cooling applications

  2. Clinical Trials

    Medline Plus

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

  3. Clinical Trials

    Medline Plus

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

  4. Chemical Pathology Laboratory Tests in Pregnancy | Bolarin ...

    African Journals Online (AJOL)

    Thus, chemical pathology laboratory investigative test results during normal healthy pregnancy show significant differences from the normal reference intervals or ranges (i.e. non-pregnant woman's reference intervals or ranges) thereby causing misinterpretation as inappropriate or odd. This wrong interpretation of the ...

  5. Building for Biology: A Gene Therapy Trial Infrastructure

    Directory of Open Access Journals (Sweden)

    Samuel Taylor-Alexander


    Full Text Available In this article, we examine the construction of the infrastructure for a Phase II gene therapy trial for Cystic Fibrosis (CF. Tracing the development of the material technologies and physical spaces used in the trial, we show how the trial infrastructure took form at the uncertain intersection of scientific norms, built environments, regulatory negotiations, patienthood, and the biologies of both disease and therapy. We define infrastructures as material and immaterial (including symbols and affect composites that serve a selective distributive purpose and facilitate projects of making and doing. There is a politics to this distributive action, which is itself twofold, because whilst infrastructures enable and delimit the movement of matter, they also mediate the very activity for which they provide the grounds. An infrastructural focus allows us to show how purposeful connections are made in a context of epistemic and regulatory uncertainty. The gene therapy researchers were working in a context of multiple uncertainties, regarding not only how to do gene therapy, but also how to anticipate and enact ambiguous regulatory requirements in a context of limited resources (technical, spatial, and financial. At the same time, the trial infrastructure had to accommodate Cystic Fibrosis biology by bridging the gap between pathology and therapy. The consortium’s approach to treating CF required that they address concerns about contamination and safety while finding a way of getting a modified gene product into the lungs of the trial participants.

  6. Physical Sciences Laboratory (PSL) (United States)

    Federal Laboratory Consortium — PNNL's Physical Sciences Laboratory (PSL) houses 22 research laboratories for conducting a wide-range of research including catalyst formulation, chemical analysis,...

  7. Distributed Energy Technology Laboratory (United States)

    Federal Laboratory Consortium — The Distributed Energy Technologies Laboratory (DETL) is an extension of the power electronics testing capabilities of the Photovoltaic System Evaluation Laboratory...

  8. Optics/Optical Diagnostics Laboratory (United States)

    Federal Laboratory Consortium — The Optics/Optical Diagnostics Laboratory supports graduate instruction in optics, optical and laser diagnostics and electro-optics. The optics laboratory provides...

  9. Ketone Diester Ingestion Impairs Time-Trial Performance in Professional Cyclists

    Directory of Open Access Journals (Sweden)

    Jill J. Leckey


    Full Text Available We investigated the effect of pre- “race” ingestion of a 1,3-butanediol acetoacetate diester on blood ketone concentration, substrate metabolism and performance of a cycling time trial (TT in professional cyclists. In a randomized cross-over design, 10 elite male cyclists completed a ~31 km laboratory-based TT on a cycling ergometer programmed to simulate the 2017 World Road Cycling Championships course. Cyclists consumed a standardized meal [2 g/kg body mass (BM carbohydrate (CHO] the evening prior to a trial day and a CHO breakfast (2 g/kg BM CHO with 200 mg caffeine on the morning of a trial day. Cyclists were randomized to consume either the ketone diester (2 × 250 mg/kg or a placebo drink, followed immediately by 200 mL diet cola, given ~ 30 min before and immediately prior to commencing a 20 min incremental warm-up. Blood samples were collected prior to and during the warm-up, pre- and post- TT and at regular intervals after the TT. Urine samples were collected pre- and post- warm-up, immediately post TT and 60 min post TT. Pre-exercise ingestion of the diester resulted in a 2 ± 1% impairment in TT performance that was associated with gut discomfort and higher perception of effort. Serum β-hydroxybutyrate, serum acetoacetate, and urine ketone concentrations increased from rest following ketone ingestion and were higher than placebo throughout the trial. Ketone ingestion induces hyperketonemia in elite professional cyclists when in a carbohydrate fed state, and impairs performance of a cycling TT lasting ~50 min.

  10. Reducing bed rest time from five to three hours does not increase complications after cardiac catheterization: the THREE CATH Trial 1 (United States)

    Matte, Roselene; Hilário, Thamires de Souza; Reich, Rejane; Aliti, Graziella Badin; Rabelo-Silva, Eneida Rejane


    Abstract Objective: to compare the incidence of vascular complications in patients undergoing transfemoral cardiac catheterization with a 6F introducer sheath followed by 3-hour versus 5-hour rest. Methods: randomized clinical trial. Subjects in the intervention group (IG) ambulated 3 hours after sheath removal, versus 5 hours in the control group (CG). All patients remained in the catheterization laboratory for 5 hours and were assessed hourly, and were contacted 24, 48, and 72 h after hospital discharge. Results: the sample comprised 367 patients in the IG and 363 in the GC. During cath lab stay, hematoma was the most common complication in both groups, occurring in 12 (3%) IG and 13 (4%) CG subjects (P=0.87). Bleeding occurred in 4 (1%) IG and 6 (2%) CG subjects (P=0.51), and vasovagal reaction in 5 (1.4%) IG and 4 (1.1%) CG subjects (P=0.75). At 24-h, 48-h, and 72-h bruising was the most commonly reported complication in both groups. None of the comparisons revealed any significant between-group differences. Conclusion: the results of this trial show that reducing bed rest time to 3 hours after elective cardiac catheterization is safe and does not increase complications as compared with a 5-hour rest. Identifier: NCT-01740856 PMID:27463113

  11. Denver District Laboratory (DEN) (United States)

    Federal Laboratory Consortium — Program CapabilitiesDEN-DO Laboratory is a multi-functional laboratory capable of analyzing most chemical analytes and pathogenic/non-pathogenic microorganisms found...


    Chapman, W. Max


    Out-of-state flat-rate mail order contract laboratories operating from states which have little or no legal control over them can do business in California without obedience to regulations that govern laboratories located within the state. The flat-rate contract principle under which some out-of-state laboratories operate is illegal in California. The use of such laboratories increases physician liability. Legislation for the control of these laboratories is difficult to construct, and laws which might result would be awkward to administer. The best remedy is for California physicians not to use an out-of-state laboratory offering contracts or conditions that it could not legally offer if it were located in California. PMID:14165875

  13. Aerosolized avian influenza virus by laboratory manipulations. (United States)

    Li, Zhiping; Li, Jinsong; Zhang, Yandong; Li, Lin; Ma, Limin; Li, Dan; Gao, Feng; Xia, Zhiping


    Avian H5N1 influenza viruses present a challenge in the laboratory environment, as they are difficult to collect from the air due to their small size and relatively low concentration. In an effort to generate effective methods of H5N1 air removal and ensure the safety of laboratory personnel, this study was designed to investigate the characteristics of aerosolized H5N1 produced by laboratory manipulations during research studies. Normal laboratory procedures used to process the influenza virus were carried out independently and the amount of virus polluting the on-site atmosphere was measured. In particular, zootomy, grinding, centrifugation, pipetting, magnetic stirring, egg inoculation, and experimental zoogenetic infection were performed. In addition, common accidents associated with each process were simulated, including breaking glass containers, syringe injection of influenza virus solution, and rupturing of centrifuge tubes. A micro-cluster sampling ambient air pollution collection device was used to collect air samples. The collected viruses were tested for activity by measuring their ability to induce hemagglutination with chicken red blood cells and to propagate in chicken embryos after direct inoculation, the latter being detected by reverse-transcription PCR and HA test. The results showed that the air samples from the normal centrifugal group and the negative-control group were negative, while all other groups were positive for H5N1. Our findings suggest that there are numerous sources of aerosols in laboratory operations involving H5N1. Thus, laboratory personnel should be aware of the exposure risk that accompanies routine procedures involved in H5N1 processing and take proactive measures to prevent accidental infection and decrease the risk of virus aerosol leakage beyond the laboratory.

  14. Aerosolized avian influenza virus by laboratory manipulations

    Directory of Open Access Journals (Sweden)

    Li Zhiping


    Full Text Available Abstract Background Avian H5N1 influenza viruses present a challenge in the laboratory environment, as they are difficult to collect from the air due to their small size and relatively low concentration. In an effort to generate effective methods of H5N1 air removal and ensure the safety of laboratory personnel, this study was designed to investigate the characteristics of aerosolized H5N1 produced by laboratory manipulations during research studies. Results Normal laboratory procedures used to process the influenza virus were carried out independently and the amount of virus polluting the on-site atmosphere was measured. In particular, zootomy, grinding, centrifugation, pipetting, magnetic stirring, egg inoculation, and experimental zoogenetic infection were performed. In addition, common accidents associated with each process were simulated, including breaking glass containers, syringe injection of influenza virus solution, and rupturing of centrifuge tubes. A micro-cluster sampling ambient air pollution collection device was used to collect air samples. The collected viruses were tested for activity by measuring their ability to induce hemagglutination with chicken red blood cells and to propagate in chicken embryos after direct inoculation, the latter being detected by reverse-transcription PCR and HA test. The results showed that the air samples from the normal centrifugal group and the negative-control group were negative, while all other groups were positive for H5N1. Conclusions Our findings suggest that there are numerous sources of aerosols in laboratory operations involving H5N1. Thus, laboratory personnel should be aware of the exposure risk that accompanies routine procedures involved in H5N1 processing and take proactive measures to prevent accidental infection and decrease the risk of virus aerosol leakage beyond the laboratory.

  15. [Accreditation of medical laboratories]. (United States)

    Horváth, Andrea Rita; Ring, Rózsa; Fehér, Miklós; Mikó, Tivadar


    In Hungary, the National Accreditation Body was established by government in 1995 as an independent, non-profit organization, and has exclusive rights to accredit, amongst others, medical laboratories. The National Accreditation Body has two Specialist Advisory Committees in the health care sector. One is the Health Care Specialist Advisory Committee that accredits certifying bodies, which deal with certification of hospitals. The other Specialist Advisory Committee for Medical Laboratories is directly involved in accrediting medical laboratory services of health care institutions. The Specialist Advisory Committee for Medical Laboratories is a multidisciplinary peer review group of experts from all disciplines of in vitro diagnostics, i.e. laboratory medicine, microbiology, histopathology and blood banking. At present, the only published International Standard applicable to laboratories is ISO/IEC 17025:1999. Work has been in progress on the official approval of the new ISO 15189 standard, specific to medical laboratories. Until the official approval of the International Standard ISO 15189, as accreditation standard, the Hungarian National Accreditation Body has decided to progress with accreditation by formulating explanatory notes to the ISO/IEC 17025:1999 document, using ISO/FDIS 15189:2000, the European EC4 criteria and CPA (UK) Ltd accreditation standards as guidelines. This harmonized guideline provides 'explanations' that facilitate the application of ISO/IEC 17025:1999 to medical laboratories, and can be used as a checklist for the verification of compliance during the onsite assessment of the laboratory. The harmonized guideline adapted the process model of ISO 9001:2000 to rearrange the main clauses of ISO/IEC 17025:1999. This rearrangement does not only make the guideline compliant with ISO 9001:2000 but also improves understanding for those working in medical laboratories, and facilitates the training and education of laboratory staff. With the

  16. The impact of laboratory quality assurance standards on laboratory operational performance

    Directory of Open Access Journals (Sweden)

    E Ratseou


    Full Text Available It has become a trend for companies to implement and be certified to various quality management systems so as to improve consistency, reliability, and quality of product delivery to customers. The most common quality management systems adopted are the ISO 9000 series of standards for manufacturing and services related organisations, with ISO 17025 and Good Laboratory Practices (GLP standards adopted specifically by laboratories as quality assurance initiatives. There are various reports on the impact of the ISO 9000 series on organisational performance but no studies or reports have been done on the performance of laboratory standards. Therefore this article reports on a study conducted to investigate the impact of ISO 17025 and GLP on the operational performance of both commercial and non-commercial laboratories. A qualitative research study was conducted to examine the impact standards on the aspects of health and safety, supplier selection and performance, human resources, customer satisfaction and profitability of the laboratory. The data collected suggest that there is no difference in laboratory operational performance with or without the standards. In other words it appears that the basic fundamental requirements inherent with laboratories are sufficient to perform both operationally and optimally. This leads to the view that standards are implemented as a customer requirement and not as an operational requirement.

  17. Laboratory quality assurance and its role in the safeguards analytical laboratory evaluation (SALE) program

    International Nuclear Information System (INIS)

    Delvin, W.L.; Pietri, C.E.


    Since the late 1960's, strong emphasis has been given to quality assurance in the nuclear industry, particularly to that part involved in nuclear reactors. This emphasis has had impact on the analytical chemistry laboratory because of the importance of analytical measurements in the certification and acceptance of materials used in the fabrication and construction of reactor components. Laboratory quality assurance, in which the principles of quality assurance are applied to laboratory operations, has a significant role to play in processing, fabrication, and construction programs of the nuclear industry. That role impacts not only process control and material certification, but also safeguards and nuclear materials accountability. The implementation of laboratory quality assurance is done through a program plan that specifies how the principles of quality assurance are to be applied. Laboratory quality assurance identifies weaknesses and deficiencies in laboratory operations and provides confidence in the reliability of laboratory results. Such confidence in laboratory measurements is essential to the proper evaluation of laboratories participating in the Safeguards Analytical Laboratory Evaluation (SALE) Program

  18. Safety in the Chemical Laboratory: Safety in the Chemistry Laboratories: A Specific Program. (United States)

    Corkern, Walter H.; Munchausen, Linda L.


    Describes a safety program adopted by Southeastern Louisiana University. Students are given detailed instructions on laboratory safety during the first laboratory period and a test which must be completely correct before they are allowed to return to the laboratory. Test questions, list of safety rules, and a laboratory accident report form are…

  19. Vehicle Development Laboratory (United States)

    Federal Laboratory Consortium — FUNCTION: Supports the development of prototype deployment platform vehicles for offboard countermeasure systems.DESCRIPTION: The Vehicle Development Laboratory is...

  20. The need for a quality standard for assurance in medical research laboratories

    Directory of Open Access Journals (Sweden)

    S Cohen


    Full Text Available The objective of this article is to show the results of a research study conducted to evaluate the need for a quality standard specific for medical research laboratories based on the shortfalls of ISO 15189 when used for this purpose. A qualitative research methodology was used, which comprised of collecting data from 20 well-qualified and experienced medical laboratory personnel by means of interviews based on a framework developed from a literature review. The data were analysed by means of a thematic technique and the results were verified by a team of medical researchers. The seven themes arising from the analyses were inflexibility; ambiguity; unfair requirements; inappropriate focus; inadequacy for research; renewal; and acceptance for accreditation. The results indicated that the ISO 15189 standard in its present content does not totally suit medical research laboratories and shows support for the development of a standard specific for research laboratories.

  1. [Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial]. (United States)

    Rozenberg, P; Deruelle, P; Sénat, M-V; Desbrière, R; Winer, N; Simon, E; Ville, Y; Kayem, G; Boutron, I


    The data from literature show that trial of labor and elective repeat cesarean delivery after a prior cesarean delivery both present significant risks and benefits, and these risks and benefits differ for the woman and her fetus. The benefits to the woman can be at the expense of her fetus and vice-versa. This uncertainty is compounded by the scarcity of high-level evidence that preclude accurate quantification of the risks and benefits that could help provide a fair counseling about a trial of labor and elective repeat cesarean delivery. An interesting way of research is to evaluate the potential benefits of a decision rule associated to the ultrasound measurement of the lower uterine segment (LUS). Indeed, ultrasonography may be helpful in determining a specific risk for a given patient by measuring the thickness of the LUS, i,e, the thickness of the cesarean delivery scar area. Although only small and often methodologically biased data have been published, they look promising as their results are concordant: ultrasonographic measurements of the LUS thickness is highly correlated with the intraoperative findings at cesarean delivery. Furthermore, the thinner the LUS becomes on ultrasound, the higher the likelihood of a defect in the LUS. Finally, ultrasound assessment of LUS has an excellent negative predictive value for the risk of uterine defect. Therefore, this exam associated with a rule of decision could help to reduce the rate of elective repeat cesarean delivery and especially to reduce the fetal and maternal mortality and morbidity related to trial of labor after a prior cesarean delivery. This is a pragmatic open multicenter randomized trial with two parallel arms. Randomization will be centralized and computerized. Since blindness is impossible, an adjudication committee will evaluate the components of the primary composite outcome in order to avoid evaluation bias. An interim analysis will be planned mid-strength of the trial. Ultrasound will be

  2. Comparison of metformin and insulin versus insulin alone for type 2 diabetes: systematic review of randomised clinical trials with meta-analyses and trial sequential analyses. (United States)

    Hemmingsen, Bianca; Christensen, Louise Lundby; Wetterslev, Jørn; Vaag, Allan; Gluud, Christian; Lund, Søren S; Almdal, Thomas


    To compare the benefits and harms of metformin and insulin versus insulin alone as reported in randomised clinical trials of patients with type 2 diabetes. Systematic review of randomised clinical trials with meta-analyses and trial sequential analyses. The Cochrane Library, Medline, Embase, Science Citation Index Expanded, Latin American Caribbean Health Sciences Literature, and Cumulative Index to Nursing and Allied Health Literature until March 2011. We also searched abstracts presented at the American Diabetes Association and European Association for the Study of Diabetes Congresses, contacted relevant trial authors and pharmaceutical companies, hand searched reference lists of included trials, and searched the US Food and Drug Administration website. Two authors independently screened titles and abstracts for randomised clinical trials comparing metformin and insulin versus insulin alone (with or without placebo) in patients with type 2 diabetes, older than 18 years, and with an intervention period of at least 12 weeks. We included trials irrespective of language, publication status, predefined outcomes, antidiabetic interventions used before randomisation, and reported outcomes. We included 26 randomised trials with 2286 participants, of which 23 trials with 2117 participants could provide data. All trials had high risk of bias. Data were sparse for outcomes relevant to patients. Metformin and insulin versus insulin alone did not significantly affect all cause mortality (relative risk 1.30, 95% confidence interval 0.57 to 2.99) or cardiovascular mortality (1.70, 0.35 to 8.30). Trial sequential analyses showed that more trials were needed before reliable conclusions could be drawn regarding these outcomes. In a fixed effect model, but not in a random effects model, severe hypoglycaemia was significantly more frequent with metformin and insulin than with insulin alone (2.83, 1.17 to 6.86). In a random effects model, metformin and insulin resulted in reduced Hb

  3. Comparison of Smoke Yield Data Collected from Different Laboratories

    Directory of Open Access Journals (Sweden)

    Teillet B


    Full Text Available In the context of increasing tobacco product regulations, more requirements are observed for the reporting of smoke constituent yield data and its variability e.g., US Food and Drug Administration (FDA. The objective of this work was to evaluate the relevance of the short term standard deviation to describe the variability of measurements using the dataset of the CORESTA 2006 Joint Experiment which included a number of cigarette smoke constituents more recently identified by FDA for reporting. Their testing protocol required the analysis of Kentucky Reference cigarettes 2R4F and 1R5F performing five replicates run over consecutive days, repeated during three different time periods. This dataset provided access to different sources of smoke yield variability across measurements: short term and medium term within-laboratory variability and among-laboratory variability. For each reference cigarette, analysis of variance on one factor (laboratory combined with the Newman-Keuls multiple range test was performed to compare data generated across laboratories. Results showed that the expression of yield variability as an individual standard deviation (describing repeatability gives erroneous conclusions due to the major contribution of amonglaboratory variability not being taken into account. The different sources of variability can be taken into account in the comparison using the critical difference, as described in the ISO Standard 5725 part 6. This paper shows the importance of having i the appropriate statistical methods to compare results from different laboratories in order to avoid erroneous conclusions, and ii validated and standardized methods with known precision across laboratories. Moreover, it was demonstrated that the number of replicates had only a minor effect on product comparison on the basis of the critical difference as a function of repeatability and reproducibility of the methods.

  4. Joint probability of statistical success of multiple phase III trials. (United States)

    Zhang, Jianliang; Zhang, Jenny J


    In drug development, after completion of phase II proof-of-concept trials, the sponsor needs to make a go/no-go decision to start expensive phase III trials. The probability of statistical success (PoSS) of the phase III trials based on data from earlier studies is an important factor in that decision-making process. Instead of statistical power, the predictive power of a phase III trial, which takes into account the uncertainty in the estimation of treatment effect from earlier studies, has been proposed to evaluate the PoSS of a single trial. However, regulatory authorities generally require statistical significance in two (or more) trials for marketing licensure. We show that the predictive statistics of two future trials are statistically correlated through use of the common observed data from earlier studies. Thus, the joint predictive power should not be evaluated as a simplistic product of the predictive powers of the individual trials. We develop the relevant formulae for the appropriate evaluation of the joint predictive power and provide numerical examples. Our methodology is further extended to the more complex phase III development scenario comprising more than two (K > 2) trials, that is, the evaluation of the PoSS of at least k₀ (k₀≤ K) trials from a program of K total trials. Copyright © 2013 John Wiley & Sons, Ltd.

  5. A virtual laboratory notebook for simulation models. (United States)

    Winfield, A J


    In this paper we describe how we have adopted the laboratory notebook as a metaphor for interacting with computer simulation models. This 'virtual' notebook stores the simulation output and meta-data (which is used to record the scientist's interactions with the simulation). The meta-data stored consists of annotations (equivalent to marginal notes in a laboratory notebook), a history tree and a log of user interactions. The history tree structure records when in 'simulation' time, and from what starting point in the tree changes are made to the parameters by the user. Typically these changes define a new run of the simulation model (which is represented as a new branch of the history tree). The tree shows the structure of the changes made to the simulation and the log is required to keep the order in which the changes occurred. Together they form a record which you would normally find in a laboratory notebook. The history tree is plotted in simulation parameter space. This shows the scientist's interactions with the simulation visually and allows direct manipulation of the parameter information presented, which in turn is used to control directly the state of the simulation. The interactions with the system are graphical and usually involve directly selecting or dragging data markers and other graphical control devices around in parameter space. If the graphical manipulators do not provide precise enough control then textual manipulation is still available which allows numerical values to be entered by hand. The Virtual Laboratory Notebook, by providing interesting interactions with the visual view of the history tree, provides a mechanism for giving the user complex and novel ways of interacting with biological computer simulation models.

  6. NASA Space Radiation Laboratory (United States)

    Federal Laboratory Consortium — The NASA Space Radiation Laboratory (NSRL) at Brookhaven National Laboratory is a NASA funded facility, delivering heavy ion beams to a target area where scientists...

  7. Occupational radiation exposures in research laboratories

    International Nuclear Information System (INIS)

    Vaccari, S.; Papotti, E.; Pedrazzi, G.


    Radioactive sources are widely used in many research activities at University centers. In particular, the activities concerning use of sealed form ( 57 Co in Moessbauer application) and unsealed form ( 3 H, 14 C, 32 P in radioisotope laboratories) are analyzed. The radiological impact of these materials and potential effective doses to researchers and members of the public were evaluated to show compliance with regulatory limits. A review of the procedures performed by researchers and technicians in the research laboratories with the relative dose evaluations is presented in different situations, including normal operations and emergency situations, for example the fire. A study of the possible exposure to radiation by workers, restricted groups of people, and public in general, as well as environmental releases, is presented. (authors)

  8. Effectiveness of acupuncture for angina pectoris: a systematic review of randomized controlled trials. (United States)

    Yu, Changhe; Ji, Kangshou; Cao, Huijuan; Wang, Ying; Jin, Hwang Hye; Zhang, Zhe; Yang, Guanlin


    The purpose of this systematic review is to assess the effectiveness of acupuncture for angina pectoris. Eleven electronic databases were searched until January 2013. The study included randomized controlled trials that the effectiveness of acupuncture alone was compared to anti-angina medicines (in addition to conventional treatment) and the effectiveness of a combination of acupuncture plus anti-angina medicines was compared to anti-angina medicines alone. The trial selection, data extraction, quality assessment and data analytic procedures outlined in the 2011 Cochrane Handbook were involved. The study included 25 randomized controlled trials (involving 2,058 patients) that met our inclusion criteria. The pooled results showed that the number of patients with ineffectiveness of angina relief was less in the combined acupuncture-anti-angina treatment group than in the anti-angina medicines alone group (RR 0.33, 95% CI 0.23-0.47, p angina medicines alone group, fewer patients in the combined treatment group showed no ECG improvement (RR 0.50, 95% CI 0.40-0.62, p angina medicines alone for both outcome measures. Only four trials mentioned adverse effects. One trial found no significant difference between acupuncture and Chinese medicine, and three reported no adverse events. The quality of the trials was found to be low. The findings showed very low evidence to support the use of acupuncture for improving angina symptoms and ECG of angina patients. However, the quality of the trials included in this study was low. Large and rigorously designed trials are needed to confirm the potential benefit and adverse events of acupuncture.

  9. A natural mineral supplement provides relief from knee osteoarthritis symptoms: a randomized controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Kuskowski Michael A


    Full Text Available Abstract Background This small, pilot study evaluated the impact of treatment with a natural multi-mineral supplement from seaweed (Aquamin on walking distance, pain and joint mobility in subjects with moderate to severe osteoarthritis of the knee. Methods Subjects (n = 70 with moderate to severe osteoarthritis of the knee were randomized to four double-blinded treatments for 12 weeks: (a Glucosamine sulfate (1500 mg/d; (b Aquamin (2400 mg/d; (c Combined treatment composed of Glucosamine sulfate (1500 mg/d plus Aquamin (2400 mg/d and (d Placebo. Primary outcome measures were WOMAC scores and 6 Minute Walking Distances (6 MWD. Laboratory based blood tests were used as safety measures. Results Fifty subjects completed the study and analysis of the data showed significant differences between the groups for changes in WOMAC pain scores over time (p = 0.009 ANCOVA; however, these data must be reviewed with caution since significant differences were found between the groups at baseline for WOMAC pain and stiffness scores (p = 0.0039 and p = 0.013, respectively, ANOVA. Only the Aquamin and Glucosamine groups demonstrated significant improvements in symptoms over the course of the study. The combination group (like the placebo group did not show any significant improvements in OA symptoms in this trial. Within group analysis demonstrated significant improvements over time on treatment for the WOMAC pain, activity, composite and stiffness (Aquamin only scores as well as the 6 minute walking distances for subjects in the Aquamin and Glucosamine treatment groups. The Aquamin and Glucosamine groups walked 101 feet (+7% and 56 feet (+3.5% extra respectively. All treatments were well tolerated and the adverse events profiles were not significantly different between the groups. Conclusion This small preliminary study suggested that a multi mineral supplement (Aquamin may reduce the pain and stiffness of osteoarthritis of the knee over 12 weeks of treatment and

  10. 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


    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

  11. Intelligent Optics Laboratory (United States)

    Federal Laboratory Consortium — The Intelligent Optics Laboratory supports sophisticated investigations on adaptive and nonlinear optics; advancedimaging and image processing; ground-to-ground and...

  12. Lessons from the use of genetically modified Drosophila melanogaster in ecological studies: Hsf mutant lines show highly trait-specific performance in field and laboratory thermal assays

    DEFF Research Database (Denmark)

    Sørensen, Jesper Givskov; Loeschcke, Volker; Kristensen, Torsten Nygård


    . 2.  We have tested the importance of inducible heat shock proteins (Hsps) under different thermal conditions using two heat shock factor (Hsf) mutant lines (either able (Hsf+) or unable (Hsf0) to mount a heat stress response) and an outbred laboratory adapted wild-type line of Drosophila......1.  Laboratory studies on genetically modified strains may reveal important information on mechanisms involved in coping with thermal stress. However, to address the evolutionary significance of specific genes or physiological mechanisms, ecologically relevant field tests should also be performed...

  13. Chinese Herbal Medicine for Acute Mountain Sickness: A Systematic Review of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Jie Wang


    Full Text Available Objectives. We aimed to assess the current clinical evidence of Chinese herbal medicine for AMS. Methods. Seven electronic databases were searched until January 2013. We included randomized clinical trials testing Chinese herbal medicine against placebo, no drugs, Western drugs, or a combination of routine treatment drugs against routine treatment drugs. Study selection, data extraction, quality assessment, and data analyses were conducted according to Cochrane standards. Results. Nine randomized trials were included. The methodological quality of the included trials was evaluated as low. Two trials compared prescriptions of Chinese formula used alone with Western drugs. A meta-analysis showed a beneficial effect in decreasing the score of AMS (MD: −2.23 [−3.98, −0.49], P=0.01. Only one trial compared prescriptions of Chinese formula used alone with no drugs. A meta-analysis showed a significant beneficial effect in decreasing the score of AMS (MD: −6.00 [−6.45, −5.55], P<0.00001. Four trials compared Chinese formula used alone with placebo. A meta-analysis also showed a significant beneficial effect in decreasing the score of AMS (MD: −1.10 [−1.64, −0.55], P<0.0001. Two trials compared the combination of Chinese formula plus routine treatment drugs with routine treatment drugs. A meta-analysis showed a beneficial effect in decreasing the score of AMS (MD: −5.99 [−11.11, −0.86], P=0.02. Conclusions. No firm conclusion on the effectiveness and safety of Chinese herbal medicine for AMS can be made. More rigorous high-quality trials are required to generate a high level of evidence and to confirm the results.

  14. Soil/Rock Properties Laboratory (United States)

    Federal Laboratory Consortium — Soil/Rock Properties LaboratoryLocation: Spokane SiteThe Soil/Rock Properties Laboratory is contained in the soils bay, a 4,700 sq. ft. facility that provides space...


    Federal Laboratory Consortium — This laboratory contains equipment that performs a broad array of microbiological analyses for pathogenic and spoilage microorganisms. It performs challenge studies...


    Federal Laboratory Consortium — This laboratory conducts basic and applied human research studies to characterize cognitive performance as influenced by militarily-relevant contextual and physical...

  17. 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


    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

  18. REMOTE RF LABORATORY REQUIREMENTS: Engineers’ and Technicians’ Perspective

    Directory of Open Access Journals (Sweden)

    Nergiz Ercil CAGILTAY


    Full Text Available ABSTRACT This study aims to find out requirements and needs to be fulfilled in developing remote Radio Frequency (RF laboratory. Remote laboratories are newly emerging solutions for better supporting of e-learning platforms and for increasing their efficiency and effectiveness in technical education. By this way, modern universities aim to provide lifelong learning environments to extend their education for a wider area and support learners anytime and anywhere when they need help. However, as far as the authors concern, there is no study investigating the requirements and needs of remote laboratories in that particular field in the literature. This study is based on electrical engineers’ and technicians’ perspectives on the requirements of a remote laboratory in RF domain. Its scope covers investigation of the participants’ perceptions toward computer mediated communication and it attempts to answer the questions: which studying strategies are preferred by the learners and what kind of RF laboratory content should be provided. The analysis of the results showed that, geographic independence, finding quickly the elements of past communication and temporal independence are declared as the most important advantages of computer-mediated communication. However, reading significant amount of information is a problem of these environments. In the context of how to show the content, respondents want to see shorter text on the screen. Therefore the instructions should include little amount of text and must be supported with figures and interactive elements. The instructional materials developed for such learner groups should support both linear and non-linear instructions. While analyzing the content to be provided, we have seen that, most of the participants do not have access to high level equipments and traditional experiments are considered as the necessary ones for both engineers and technicians.

  19. Teaching acid/base physiology in the laboratory

    DEFF Research Database (Denmark)

    Friis, Ulla G; Plovsing, Ronni; Hansen, Klaus


    exercise in acid/base physiology that would provide students with unambiguous and reproducible data that clearly would illustrate the theory in practice. The laboratory exercise was developed to include both metabolic acidosis and respiratory alkalosis. Data were collected from 56 groups of medical...... students that had participated in this laboratory exercise. The acquired data showed very consistent and solid findings after the development of both metabolic acidosis and respiratory alkalosis. All results were consistent with the appropriate diagnosis of the acid/base disorder. Not one single group...... failed to obtain data that were compatible with the diagnosis; it was only the degree of acidosis/alkalosis and compensation that varied....

  20. Laboratory safety handbook (United States)

    Skinner, E.L.; Watterson, C.A.; Chemerys, J.C.


    Safety, defined as 'freedom from danger, risk, or injury,' is difficult to achieve in a laboratory environment. Inherent dangers, associated with water analysis and research laboratories where hazardous samples, materials, and equipment are used, must be minimized to protect workers, buildings, and equipment. Managers, supervisors, analysts, and laboratory support personnel each have specific responsibilities to reduce hazards by maintaining a safe work environment. General rules of conduct and safety practices that involve personal protection, laboratory practices, chemical handling, compressed gases handling, use of equipment, and overall security must be practiced by everyone at all levels. Routine and extensive inspections of all laboratories must be made regularly by qualified people. Personnel should be trained thoroughly and repetitively. Special hazards that may involve exposure to carcinogens, cryogenics, or radiation must be given special attention, and specific rules and operational procedures must be established to deal with them. Safety data, reference materials, and texts must be kept available if prudent safety is to be practiced and accidents prevented or minimized.

  1. A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial. (United States)

    Cutolo, Maurizio; Myerson, Gary E; Fleischmann, Roy M; Lioté, Frédéric; Díaz-González, Federico; Van den Bosch, Filip; Marzo-Ortega, Helena; Feist, Eugen; Shah, Kamal; Hu, ChiaChi; Stevens, Randall M; Poder, Airi


    Apremilast, an oral phosphodiesterase 4 inhibitor, downregulates intracellular inflammatory mediator synthesis by elevating cyclic adenosine monophosphate levels. The PALACE 2 trial evaluated apremilast efficacy and safety in patients with active psoriatic arthritis (PsA) despite prior conventional disease-modifying antirheumatic drugs and/or biologic therapy. Eligible patients were randomized (1:1:1) to placebo, apremilast 20 mg BID, or apremilast 30 mg BID. At Week 16, patients with swollen and tender joint count improvement 20% improvement in American College of Rheumatology response criteria (ACR20) at Week 16. In the intent-to-treat population (N = 484), ACR20 at Week 16 was achieved by more patients receiving apremilast 20 mg BID [37.4% (p = 0.0002)] and 30 mg BID [32.1% (p = 0.0060)] versus placebo (18.9%). Clinically meaningful improvements in signs and symptoms of PsA, physical function, and psoriasis were observed with apremilast through Week 52. The most common adverse events were diarrhea, nausea, headache, and upper respiratory tract infection. Diarrhea and nausea generally occurred early and usually resolved spontaneously with continued treatment. Laboratory abnormalities were infrequent and transient. Apremilast demonstrated clinical improvements in PsA for up to 52 weeks, including signs and symptoms, physical function, and psoriasis. No new safety signals were observed. identifier: NCT01212757.

  2. Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration.

    Directory of Open Access Journals (Sweden)

    Amelia Scott

    Full Text Available To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.Any clinical trial (as defined by ICMJE published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry and conducted after July 2005 (or 2007 for two journals was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6% were deemed unregistered, 61 (33.7% were retrospectively registered, 37 (20.4% had unclear POMs either in the article or the registry and 2 (1.1% were registered in an inaccessible trial registry. Only 60 (33.1% studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3% showed evidence of selective outcome reporting and 16 (26.7% demonstrated a change in participant numbers of 20% or more; only 26 (14

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

    Directory of Open Access Journals (Sweden)

    Matt David Thomas Hitchings


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

  4. First-year Engineering Education with the Creative Electrical Engineering Laboratory (United States)

    Tsukamoto, Takehiko; Sugito, Tetsumasa; Ozeki, Osamu; Ushiroda, Sumio

    The Department of Electrical and Electronic Engineering in Toyota National College of Technology has put great emphasis on fundamental subjects. We introduced the creative electrical engineering laboratory into the first-year engineering education since 1998. The laboratory concentrates on the practice exercise. The final questionnaire of students showed that our first-year education is very effective to promote students motivation and their scholastic ability in engineering.

  5. Prognostic value of site SYNTAX score and rationale for combining anatomic and clinical factors in decision making: Insights from the SYNTAX trial

    NARCIS (Netherlands)

    Y.-J. Zhang (Yao-Jun); A. Iqbal (Anwarul); C.A.M. Campos (Carlos); D. van Klaveren (David); C.V. Bourantas (Christos); K.D. Dawkins (Keith); A. Banning (Adrian); J. Escaned (Javier); T. de Vries (Ton); M-A.M. Morel (Marie-Angèle); V. Farooq (Vasim); Y. Onuma (Yoshinobu); H.M. Garcia-Garcia (Hector); G.W. Stone (Gregg); E.W. Steyerberg (Ewout); F.W. Mohr (Friedrich); P.W.J.C. Serruys (Patrick)


    textabstractBackground The results of SYNTAX trial have been reported based on "corelab" calculated SS (cSS). It has been shown that reproducibility of SS is better among the core laboratory technicians than interventional cardiologists. Thus, the prognostic value and clinical implication of the

  6. Central Laboratories Services (United States)

    Federal Laboratory Consortium — The TVA Central Laboratories Services is a comprehensive technical support center, offering you a complete range of scientific, engineering, and technical services....

  7. Embedded Processor Laboratory (United States)

    Federal Laboratory Consortium — The Embedded Processor Laboratory provides the means to design, develop, fabricate, and test embedded computers for missile guidance electronics systems in support...

  8. Geospatial Services Laboratory (United States)

    Federal Laboratory Consortium — FUNCTION: To process, store, and disseminate geospatial data to the Department of Defense and other Federal agencies.DESCRIPTION: The Geospatial Services Laboratory...

  9. [Theme: Using Laboratories. (United States)

    Pritchard, Jack; Braker, Clifton


    Pritchard discusses the opportunities for applied learning afforded by laboratories. Braker describes the evaluation of cognitive, affective, and psychomotor skills in the agricultural mechanics laboratory. (SK)

  10. Environmental Microbiology Laboratory (United States)

    Federal Laboratory Consortium — The Environmental Microbiology Laboratory, located in Bldg. 644 provides a dual-gas respirometer for measurement of oxygen consumption and carbon dioxide evolution...

  11. Adult Hematology and Clinical Chemistry Laboratory Reference Ranges in a Zimbabwean Population. (United States)

    Samaneka, Wadzanai P; Mandozana, Gibson; Tinago, Willard; Nhando, Nehemiah; Mgodi, Nyaradzo M; Bwakura-Dangarembizi, Mutsawashe F; Munjoma, Marshall W; Gomo, Zvenyika A R; Chirenje, Zvavahera M; Hakim, James G


    Laboratory reference ranges used for clinical care and clinical trials in various laboratories in Zimbabwe were derived from textbooks and research studies conducted more than ten years ago. Periodic verification of these ranges is essential to track changes over time. The purpose of this study was to establish hematology and chemistry laboratory reference ranges using more rigorous methods. A community-based cross-sectional study was carried out in Harare, Chitungwiza, and Mutoko. A multistage sampling technique was used. Samples were transported from the field for analysis at the ISO15189 certified University of Zimbabwe-University of California San Francisco Central Research Laboratory. Hematology and clinical chemistry reference ranges lower and upper reference limits were estimated at the 2.5th and 97.5th percentiles respectively. A total of 769 adults (54% males) aged 18 to 55 years were included in the analysis. Median age was 28 [IQR: 23-35] years. Males had significantly higher red cell counts, hemoglobin, hematocrit, and mean corpuscular hemoglobin compared to females. Females had higher white cell counts, platelets, absolute neutrophil counts, and absolute lymphocyte counts compared to males. There were no gender differences in eosinophils, monocytes, and absolute basophil count. Males had significantly higher levels of urea, sodium, potassium, calcium, creatinine, amylase, total protein, albumin and liver enzymes levels compared to females. Females had higher cholesterol and lipase compared with males. There are notable differences in the white cell counts, neutrophils, cholesterol, and creatinine kinase when compared with the currently used reference ranges. Data from this study provides new country specific reference ranges which should be immediately adopted for routine clinical care and accurate monitoring of adverse events in research studies.

  12. Characteristics of the radiation prevention metrology laboratory 'Cajavec' - Banjaluka

    International Nuclear Information System (INIS)

    Tomljenovic, I.; Ninkovic, M.; Kolonic, Dz.


    Radiation metrology laboratory built in the factory 'Cajavec' in Banja Luka, planed for gauge the detectors of ionization radiation. Laboratory as part of the large factory building , thus projected and formed according to positive radiation principles. Walls are constructed of basic concrete, main entrance of lead, approaching the radiation bench from the back side. Sound and light signal system connected with dosemeter for showing mini dose of radiation creating conditions for safe work of the dosemeterists. (author) [sr

  13. Sustainable Treatment and Reuse of Diluted Pig Manure Streams in Russia: From Laboratory Trials to Full-Scale Implementation

    NARCIS (Netherlands)

    Kalyuzhnyi, S.; Sklyar, V.; Epov, A.; Arkhipchenko, I.; Barboulina, I.; Orlova, O.; Kovalev, A.; Nozhevnikova, A.; Klapwijk, A.


    This article summarizes the results obtained during the laboratory and pilot development of integrated biologic and physicochemical treatment and reuse of diluted pig manure streams. The application of a straw filter was an effective means to separate the solid and liquid fractions of raw wastewater

  14. Modern clinical laboratory diagnostics

    International Nuclear Information System (INIS)

    Balakhovskij, I.S.


    Laboratory diagnosis is auxillary medical discipline studying specific laboratory symptoms of diseases, revealed by investigations of materials taken from patients. The structure of laboratory servie in our country and abroad, items of laboratory investigations, organizational principles are described. Attention is being given to the cost of analyses, the amount of conducted investigations, methods of result presentation, problems of accuracy, quality control and information content

  15. Tendências em medicina laboratorial Trends in laboratory medicine

    Directory of Open Access Journals (Sweden)

    Gustavo Aguiar Campana


    Full Text Available A patologia clínica/medicina laboratorial é uma especialidade direcionada à realização de exames complementares no auxílio ao diagnóstico, com impacto nos diferentes estágios da cadeia de saúde: prevenção, diagnóstico, prognóstico e acompanhamento terapêutico. Diversos elementos apontam para maior utilização da medicina diagnóstica no futuro. Para discutirmos as principais tendências na medicina laboratorial, descrevemos os fatores que colaboram e são fundamentais para o crescimento desse mercado denominados, neste estudo, drivers de crescimento. As principais tendências que terão forte impacto na medicina laboratorial, e que serão descritas neste artigo, são: ferramentas de gestão, inserção de novos testes no mercado e rol de procedimentos, qualidade dos serviços em medicina diagnóstica, modelos de operação, automação, consolidação e integração, tecnologia da informação, medicina personalizada e genética. Sabemos que a medicina diagnóstica demonstra sua importância ao participar de 70% das decisões clínicas, absorvendo uma pequena parte dos custos em saúde (cerca de 10%. Todas as tendências analisadas neste trabalho apontam para um crescimento na utilização dos exames laboratoriais e também para sua importância na cadeia de saúde. Esse novo posicionamento, somado às novas expectativas de alta resolubilidade, pressiona o mercado e as companhias que o compõem a buscar mudanças e novas estratégias de atuação.Clinical pathology/laboratory medicine, a specialty focused on performing complementary tests to aid diagnosis, has impact upon several stages of health care: prevention, diagnosis, prognosis, and therapeutic management. There are several factors that will foster the use of laboratory medicine in the future. In order to discuss the main trends in laboratory medicine, this article describes the major factors that have promoted growth in this market, which herein are referred to as growth

  16. Acoustic Technology Laboratory (United States)

    Federal Laboratory Consortium — This laboratory contains an electro-magnetic worldwide data collection and field measurement capability in the area of acoustic technology. Outfitted by NASA Langley...

  17. Wireless Emulation Laboratory (United States)

    Federal Laboratory Consortium — The Wireless Emulation Laboratory (WEL) is a researchtest bed used to investigate fundamental issues in networkscience. It is a research infrastructure that emulates...

  18. Sandia National Laboratories (United States)

    Federal Laboratory Consortium — For more than 60 years, Sandia has delivered essential science and technology to resolve the nation's most challenging security issues.Sandia National Laboratories...

  19. Photovoltaic Characterization Laboratory (United States)

    Federal Laboratory Consortium — NIST's PV characterization laboratory is used to measure the electrical performance and opto-electronic properties of solar cells and modules. This facility consists...

  20. Electro-Deposition Laboratory (United States)

    Federal Laboratory Consortium — The electro-deposition laboratory can electro-deposit various coatings onto small test samples and bench level prototypes. This facility provides the foundation for...

  1. Fuels Processing Laboratory (United States)

    Federal Laboratory Consortium — NETL’s Fuels Processing Laboratory in Morgantown, WV, provides researchers with the equipment they need to thoroughly explore the catalytic issues associated with...

  2. Composites Characterization Laboratory (United States)

    Federal Laboratory Consortium — The purpose of the Composites Characterization Laboratory is to investigate new and/or modified matrix materials and fibers for advanced composite applications both...

  3. Space Weather Laboratory (United States)

    Federal Laboratory Consortium — The Space Weather Computational Laboratory is a Unix and PC based modeling and simulation facility devoted to research analysis of naturally occurring electrically...

  4. Thermogravimetric Analysis Laboratory (United States)

    Federal Laboratory Consortium — At NETL’s Thermogravimetric Analysis Laboratory in Morgantown, WV, researchers study how chemical looping combustion (CLC) can be applied to fossil energy systems....

  5. Oil water laboratory

    International Nuclear Information System (INIS)

    P Junior, Oswaldo A.; Verli, Fernando; Lopes, Humberto E.


    Usually, the oily water effluent from petroleum processes needs to be treated prior to its environment discard and/or reuse. The synthesis of such water effluent residues in an Oily Water Laboratory - equipped with Water Treatment Pilot Scale Units - is fundamental to the study and effectiveness comparison among the typical industrial water treatment processes. The Oily Water Laboratory will allow the reproduction - in a small scale - of any oily water effluent produced in the industrial PETROBRAS units - such reproduction can be obtained by using the same fluids, oily concentration, salinity, process temperature, particle size distribution etc. Such Laboratory also allows the performance analysis of typical industrial equipment used throughout the water treatment schemes (e.g., hydro-cyclones), resulting in design and/or operational guidelines for these industrial scale schemes. In the particular niche of very small diameter oil droplet removal, more efficient and non-conventional schemes - such as centrifuges and/or membrane filtration - will be also studied in the Laboratory. In addition, the Laboratory shall be used in the certification of in-line oily water analyzers (e.g., TOC - Total Organic Carbon and OWC - Oil Wax Content). This paper describes the characteristics of such Laboratory and its main operational philosophy. (author)

  6. Laboratory Safety Awareness Among General Physics Undergraduate Students

    Directory of Open Access Journals (Sweden)

    C. O. Ponferrada


    Full Text Available Safety awareness in the laboratory is essential to reduce occupational risks. This study was conducted to determine the students’ safety awareness in a Physics laboratory. This study determined the student perception towards safety awareness by factors of gender and college from which students are enrolled. A sum of 324 students enrolled in Physics10 (Mechanics and Heat and Physics11 (Electricity and Magnetism in the Mindanao University of Science and Technology (MUST were randomly selected as survey respondents. A modified survey questionnaire was used as research instrument. The results show that the students had positive level of safety awareness and perceived positively on the preventive measures to reduce laboratory risk. Further, regardless of gender students enrolled in Physics 10 were more positively aware towards safety awareness than students enrolled in Physics 11. Similarly, a variation among the students perception towards safety awareness from the College of Engineering and Architecture (CEA and College of Industrial and Information Technology (CIIT occurred. Overall, present findings indicate a need to introduce laboratory safety awareness in Physics classes.

  7. The communication of laboratory investigations by university entrants (United States)

    Campbell, Bob; Kaunda, Loveness; Allie, Saalih; Buffler, Andy; Lubben, Fred


    The purpose of the study reported here was to analyse the ways in which unversity entrant science students carry out and communicate experimental activities and to identify a model to explain characteristic communication practices. The study was prompted by a need to inform the development of an introductory laboratory course. The students studied shared an educational background characterised by a lack of experience with laboratory work and scientific writing. Seven groups of three students were studied. The investigative strategies of these groups were observed. Laboratory reports were used to identify the ways in which students communicated these strategies. Data are presented that show a discrepancy between the strategies used and those reported. The results suggest that: (i) students' perceptions of the purpose of a laboratory task influence their decisions on what to report; (ii) understandings of laboratory procedures greatly influence their decision on what to report and on how much detail to include in a report and; (iii) knowledge of discourse rules contributes to effective reporting. It is concluded that students' communication of an investigation results from the differential operation of various perceptual filters that determine both the procedural and discourse elements of their reports. It is recommended that the communication of science should be taught explicitly and alongside the procedures and concepts of science.

  8. ABACC laboratories quality assurance through Secondary Standards Exchange Program

    International Nuclear Information System (INIS)

    Guidicini, Olga Mafra; Thompson, Jay; Soriano, Michael


    In September 1999, the Brazilian-Argentine Agency for Accounting and Control of Nuclear Materials (ABACC), with assistance from the New Brunswick Laboratory (NBL) of the U.S. Department of Energy, started a new cooperative activity with, among other objectives, the production and characterization of a traceable uranium secondary standard and the performance of the Third Round Robin for ABACC's laboratory network. Brazil and Argentina have fabricated UO 2 pellets for use as a secondary standard. Samples from the two batches were sent to NBL for the determination of the reference values for both uranium concentration (%U) and isotopic composition for each batch. ABACC and NBL then organized the Third ABACC Round Robin for Brazilian and Argentine laboratories that are part of the ABACC network. The laboratories comprising the network can be used to analyze real samples collected during the ABACC inspections. The Brazilian and Argentine pellets were distributed to all the laboratories together with the protocol to be followed for the uranium concentration analysis, the forms for reporting the measurement results, and natural UO 2 pellets (CETAMA OU1) to be used as reference material. For the laboratories with capability of measuring isotopics, NBL reference material CRM 125-A was provided. Several laboratories from each country provided results. As soon as the measurement results were sent to the organizers, they were statistically evaluated by NBL. During a meeting held at ABACC headquarters with the participation of NBL representatives, the ABACC technical support officer, and representatives of all the participant laboratories, the results were discussed and compared with the reference values. All the laboratories had the occasion, in an open discussion, to explain and show the difficulties and problems they faced during the exercise. ABACC had the opportunity not only to judge the quality of the measurements these laboratories performed, but also to determine

  9. Rapid Prototyping Laboratory (United States)

    Federal Laboratory Consortium — The ARDEC Rapid Prototyping (RP) Laboratory was established in December 1992 to provide low cost RP capabilities to the ARDEC engineering community. The Stratasys,...

  10. Geological Services Laboratory (United States)

    Federal Laboratory Consortium — Researchers use computed tomography (CT) scanners at NETL’s Geological Services Laboratory in Morgantown, WV, to peer into geologic core samples to determine how...

  11. Advanced Manufacturing Laboratory (United States)

    Federal Laboratory Consortium — The Advanced Manufacturing Laboratory at the University of Maryland provides the state of the art facilities for realizing next generation products and educating the...

  12. Combustion Research Laboratory (United States)

    Federal Laboratory Consortium — The Combustion Research Laboratory facilitates the development of new combustion systems or improves the operation of existing systems to meet the Army's mission for...

  13. Neural Systems Laboratory (United States)

    Federal Laboratory Consortium — As part of the Electrical and Computer Engineering Department and The Institute for System Research, the Neural Systems Laboratory studies the functionality of the...

  14. Investigating Student Perceptions of the Chemistry Laboratory and Their Approaches to Learning in the Laboratory (United States)

    Berger, Spencer Granett

    This dissertation explores student perceptions of the instructional chemistry laboratory and the approaches students take when learning in the laboratory environment. To measure student perceptions of the chemistry laboratory, a survey instrument was developed. 413 students responded to the survey during the Fall 2011 semester. Students' perception of the usefulness of the laboratory in helping them learn chemistry in high school was related to several factors regarding their experiences in high school chemistry. Students' perception of the usefulness of the laboratory in helping them learn chemistry in college was also measured. Reasons students provided for the usefulness of the laboratory were categorized. To characterize approaches to learning in the laboratory, students were interviewed midway through semester (N=18). The interviews were used to create a framework describing learning approaches that students use in the laboratory environment. Students were categorized into three levels: students who view the laboratory as a requirement, students who believe that the laboratory augments their understanding, and students who view the laboratory as an important part of science. These categories describe the types of strategies students used when conducting experiments. To further explore the relationship between students' perception of the laboratory and their approaches to learning, two case studies are described. These case studies involve interviews in the beginning and end of the semester. In the interviews, students reflect on what they have learned in the laboratory and describe their perceptions of the laboratory environment. In order to encourage students to adopt higher-level approaches to learning in the laboratory, a metacognitive intervention was created. The intervention involved supplementary questions that students would answer while completing laboratory experiments. The questions were designed to encourage students to think critically about the

  15. Prototype prosperity-diversity game for the Laboratory Development Division of Sandia National Laboratories

    Energy Technology Data Exchange (ETDEWEB)

    VanDevender, P.; Berman, M.; Savage, K.


    The Prosperity Game conducted for the Laboratory Development Division of National Laboratories on May 24--25, 1995, focused on the individual and organizational autonomy plaguing the Department of Energy (DOE)-Congress-Laboratories` ability to manage the wrenching change of declining budgets. Prosperity Games are an outgrowth and adaptation of move/countermove and seminar War Games. Each Prosperity Game is unique in that both the game format and the player contributions vary from game to game. This particular Prosperity Game was played by volunteers from Sandia National Laboratories, Eastman Kodak, IBM, and AT&T. Since the participants fully control the content of the games, the specific outcomes will be different when the team for each laboratory, Congress, DOE, and the Laboratory Operating Board (now Laboratory Operations Board) is composed of executives from those respective organizations. Nevertheless, the strategies and implementing agreements suggest that the Prosperity Games stimulate cooperative behaviors and may permit the executives of the institutions to safely explore the consequences of a family of DOE concert.

  16. [How do hospital clinical laboratories and laboratory testing companies cooperate and build reciprocal relations?]. (United States)

    Kawano, Seiji


    As the 2nd Joint Symposium of the Japanese Society of Laboratory Medicine and the Japanese Association of Laboratory Pathologists, the symposium on clinical test out-sourcing and branch laboratories was held at the 60th General Meeting of the Japanese Society of Laboratory Medicine on November 2nd, 2013 in Kobe. For the symposium, we conducted a questionnaire survey on the usage of clinical test out-sourcing and the introduction of branch laboratories to clinical laboratories of Japanese university hospitals, both private and public, between July 25th and August 20th, 2013. Seventy-two hospitals responded to the questionnaire survey, consisting of 41 public medical school hospitals and 31 private ones. According to the survey, the selection of each clinical test for out-sourcing was mainly determined by the capacities of hospital clinical laboratories and their equipment, as well as the profitability of each test. The main concerns of clinical laboratory members of university hospitals involved the continuity of measurement principles, traceability, and standardization of reference values for each test. They strongly requested the interchangeability and computerization of test data between laboratory testing companies. A branch laboratory was introduced to six hospitals, all of which were private medical college hospitals, out of 72 university hospitals, and eight of the other hospitals were open to its introduction. The merits and demerits of introducing a branch laboratory were also discussed. (Review).

  17. The management of clinical laboratories in Europe: a FESCC survey. Forum of the European Societies of Clinical Chemistry and Laboratory Medicine. (United States)

    de Kieviet, Wim; Blaton, Victor; Kovacs, Gabor L; Palicka, Vladimir; Pulkki, Kari


    The professional duties of the specialists in clinical chemistry differ from country to country in Europe. One of the main goals of the Strategic Plan of the Forum of the European Societies of Clinical Chemistry and Laboratory Medicine (FESCC; IFCC-Europe) is to promote a high scientific and professional standard in the field of clinical chemistry and laboratory medicine in Europe. This can be stimulated by the knowledge of the local conditions in each country and by striving towards a strong and harmonised position in all the European countries. In order to enhance the knowledge of the managerial situation of the specialists in clinical chemistry in Europe, FESCC launched a survey in September 2000. This survey provides information about the position of the specialists in clinical chemistry in the various disciplines in the medical laboratories and in hospitals, and about the advisory tasks and the managerial education during the post-graduate training in clinical chemistry. Of the 35 FESCC member countries 33 have participated in the survey (94%). The results show a rather heterogeneous situation in Europe caused by the local historical developments, the differences in academic background and the relative numbers of private and physicians' office laboratories. Large differences exist between the European countries in the disciplines of laboratory medicine that are headed by a specialist in clinical chemistry. In the different countries the clinical chemistry laboratories are headed by specialists in clinical chemistry in between 20% and 100% of the laboratories. The haematology, immunology, microbiology, therapeutic drug monitoring, molecular biology and haemostasis laboratories and departments of blood banking are headed by specialists in clinical chemistry in between 0% and 100% of the laboratories. The responsibilities for the various managerial tasks of the specialists in clinical chemistry show no uniformity in Europe. In the majority of the countries the

  18. Type 1 Diabetes TrialNet--an international collaborative clinical trials network. (United States)

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


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

  19. Energy Materials Research Laboratory (EMRL) (United States)

    Federal Laboratory Consortium — The Energy Materials Research Laboratory at the Savannah River National Laboratory (SRNL) creates a cross-disciplinary laboratory facility that lends itself to the...

  20. Quality assurance practices in Europe: a survey of molecular genetic testing laboratories (United States)

    Berwouts, Sarah; Fanning, Katrina; Morris, Michael A; Barton, David E; Dequeker, Elisabeth


    In the 2000s, a number of initiatives were taken internationally to improve quality in genetic testing services. To contribute to and update the limited literature available related to this topic, we surveyed 910 human molecular genetic testing laboratories, of which 291 (32%) from 29 European countries responded. The majority of laboratories were in the public sector (81%), affiliated with a university hospital (60%). Only a minority of laboratories was accredited (23%), and 26% was certified. A total of 22% of laboratories did not participate in external quality assessment (EQA) and 28% did not use reference materials (RMs). The main motivations given for accreditation were to improve laboratory profile (85%) and national recognition (84%). Nearly all respondents (95%) would prefer working in an accredited laboratory. In accredited laboratories, participation in EQA (Pquality assurance (Pquality implementation score (QIS), we showed that accredited laboratories (average score 92) comply better than certified laboratories (average score 69, Pquality indicators. We conclude that quality practices vary widely in European genetic testing laboratories. This leads to a potentially dangerous situation in which the quality of genetic testing is not consistently assured. PMID:22739339