Teleradiology (TELEACE) system: results of a field trial

International Nuclear Information System (INIS)

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

1993-01-01

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

Soil stabilization field trial : interim report.

Science.gov (United States)

2001-04-01

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

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

Directory of Open Access Journals (Sweden)

Sefzat, David

2014-02-01

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

Malaria vaccines: lessons from field trials

Directory of Open Access Journals (Sweden)

Claudio J. Struchiner

1994-07-01

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

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

Directory of Open Access Journals (Sweden)

Anne eFocke

2013-07-01

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

Microwave bale moisture sensing: Field trial

Science.gov (United States)

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

7 CFR 1755.3 - Field trials.

Science.gov (United States)

2010-01-01

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

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

NARCIS (Netherlands)

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

2003-01-01

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

IAEA monitoring field trials workshop

International Nuclear Information System (INIS)

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

1995-01-01

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

Soil stabilization field trial : interim report II.

Science.gov (United States)

2002-02-01

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

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

Directory of Open Access Journals (Sweden)

Vojtech Huser

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

Feasibility and acceptability of the DSM-5 Field Trial procedures in the Johns Hopkins Community Psychiatry Programs†

Science.gov (United States)

Clarke, Diana E.; Wilcox, Holly C.; Miller, Leslie; Cullen, Bernadette; Gerring, Joan; Greiner, Lisa H.; Newcomer, Alison; Mckitty, Mellisha V.; Regier, Darrel A.; Narrow, William E.

2014-01-01

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) contains criteria for psychiatric diagnoses that reflect advances in the science and conceptualization of mental disorders and address the needs of clinicians. DSM-5 also recommends research on dimensional measures of cross-cutting symptoms and diagnostic severity, which are expected to better capture patients’ experiences with mental disorders. Prior to its May 2013 release, the American Psychiatric Association (APA) conducted field trials to examine the feasibility, clinical utility, reliability, and where possible, the validity of proposed DSM-5 diagnostic criteria and dimensional measures. The methods and measures proposed for the DSM-5 field trials were pilot tested in adult and child/adolescent clinical samples, with the goal to identify and correct design and procedural problems with the proposed methods before resources were expended for the larger DSM-5 Field Trials. Results allowed for the refinement of the protocols, procedures, and measures, which facilitated recruitment, implementation, and completion of the DSM-5 Field Trials. These results highlight the benefits of pilot studies in planning large multisite studies. PMID:24615761

Soil stabilization field trial : interim report III.

Science.gov (United States)

2003-11-01

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

Soil stabilization field trial : interim report I.

Science.gov (United States)

2001-04-01

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

Tomographic retrieval of cloud liquid water fields from a single scanning microwave radiometer aboard a moving platform – Part 1: Field trial results from the Wakasa Bay experiment

Directory of Open Access Journals (Sweden)

D. Huang

2010-07-01

Full Text Available Tomographic methods offer great potential for retrieving three-dimensional spatial distributions of cloud liquid water from radiometric observations by passive microwave sensors. Fixed tomographic systems require multiple radiometers, while mobile systems can use just a single radiometer. Part 1 (this paper examines the results from a limited cloud tomography trial with a single-radiometer airborne system carried out as part of the 2003 AMSR-E validation campaign over Wakasa Bay of the Sea of Japan. During this trial, the Polarimetric Scanning Radiometer (PSR and Microwave Imaging Radiometer (MIR aboard the NASA P-3 research aircraft provided a useful dataset for testing the cloud tomography method over a system of low-level clouds. We do tomographic retrievals with a constrained inversion algorithm using three configurations: PSR, MIR, and combined PSR and MIR data. The liquid water paths from the PSR retrieval are consistent with those from the MIR retrieval. The retrieved cloud field based on the combined data appears to be physically plausible and consistent with the cloud image obtained by a cloud radar. We find that some vertically-uniform clouds appear at high altitudes in the retrieved field where the radar shows clear sky. This is likely due to the sub-optimal data collection strategy. This sets the stage for Part 2 of this study that aims to define optimal data collection strategies using observation system simulation experiments.

RTOG: Updated results of randomized trials

International Nuclear Information System (INIS)

Curran, Walter J.

1997-01-01

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

Feasibility and acceptability of the DSM-5 Field Trial procedures in the Johns Hopkins Community Psychiatry Programs.

Science.gov (United States)

Clarke, Diana E; Wilcox, Holly C; Miller, Leslie; Cullen, Bernadette; Gerring, Joan; Greiner, Lisa H; Newcomer, Alison; McKitty, Mellisha V; Regier, Darrel A; Narrow, William E

2014-06-01

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) contains criteria for psychiatric diagnoses that reflect advances in the science and conceptualization of mental disorders and address the needs of clinicians. DSM-5 also recommends research on dimensional measures of cross-cutting symptoms and diagnostic severity, which are expected to better capture patients' experiences with mental disorders. Prior to its May 2013 release, the American Psychiatric Association (APA) conducted field trials to examine the feasibility, clinical utility, reliability, and where possible, the validity of proposed DSM-5 diagnostic criteria and dimensional measures. The methods and measures proposed for the DSM-5 field trials were pilot tested in adult and child/adolescent clinical samples, with the goal to identify and correct design and procedural problems with the proposed methods before resources were expended for the larger DSM-5 Field Trials. Results allowed for the refinement of the protocols, procedures, and measures, which facilitated recruitment, implementation, and completion of the DSM-5 Field Trials. These results highlight the benefits of pilot studies in planning large multisite studies. Copyright © 2013, American Psychiatric Association. All rights reserved.

PV domestic field trial. Third annual technical report

Energy Technology Data Exchange (ETDEWEB)

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

2004-07-01

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

Interpreting clinical trial results by deductive reasoning: In search of improved trial design.

Science.gov (United States)

Kurbel, Sven; Mihaljević, Slobodan

2017-10-01

Clinical trial results are often interpreted by inductive reasoning, in a trial design-limited manner, directed toward modifications of the current clinical practice. Deductive reasoning is an alternative in which results of relevant trials are combined in indisputable premises that lead to a conclusion easily testable in future trials. © 2017 WILEY Periodicals, Inc.

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

Energy Technology Data Exchange (ETDEWEB)

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

2012-04-15

presents and discusses the results of the testing. It was found that the different potential zones had negligible effect on the properties of the mainline and field joint coatings. The post-field trial properties of the mainline coatings were unaltered (i.e. same as pre-field trial) despite burial for over 2 years. Although the mechanical properties (flexibility and impact resistance) of the field joint coatings were acceptable, the coatings' water soak and cathodic disbondment resistance were far inferior to those of the mainline coating. This can be related to the comparably lower adhesion, and directly attributed to the adhesion promoting chromate pre-treatment used for mainline coatings, but not so for field joints. This is stipulated by environmental legislation. This is an area which needs to be addressed prior to X100 being used in any future project.

Results of the gas carrier reliquefaction plant trial

Directory of Open Access Journals (Sweden)

Y. Fatyhov

2007-12-01

Full Text Available In the paper results of the gas carrier reliquefaction plant trial are considered. Safe transportation of liquefied gases is explained. The construction of the ship on trial is described. Designed parameters of the reliquefaction plant are presented. Heat gain into cargo tanks is obtained. Volumetric capacity, cooling capacity, volumetric efficiency and power consumption of the compressors are determined. Results of the main engine trial, diesel generator trial, reliquefaction plant trial, and calculations performed after wards are represented in five tables. The results obtained may be used for optimisation calculations of gas carriers’ reliquefaction plants.

Trial manufacture of ITER toroidal field coil radial plate

International Nuclear Information System (INIS)

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

2012-01-01

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

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

International Nuclear Information System (INIS)

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

2012-01-01

discusses the results of the testing. It was found that the different potential zones had negligible effect on the properties of the mainline and field joint coatings. The post-field trial properties of the mainline coatings were unaltered (i.e. same as pre-field trial) despite burial for over 2 years. Although the mechanical properties (flexibility and impact resistance) of the field joint coatings were acceptable, the coatings' water soak and cathodic disbondment resistance were far inferior to those of the mainline coating. This can be related to the comparably lower adhesion, and directly attributed to the adhesion promoting chromate pre-treatment used for mainline coatings, but not so for field joints. This is stipulated by environmental legislation. This is an area which needs to be addressed prior to X100 being used in any future project.

Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

Science.gov (United States)

Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

2017-12-01

Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (ppublication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

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

International Nuclear Information System (INIS)

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

1999-01-01

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

Design and Management of Field Trials of Transgenic Cereals

Science.gov (United States)

Bedő, Zoltán; Rakszegi, Mariann; Láng, László

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

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

Directory of Open Access Journals (Sweden)

S. Kannan

2016-03-01

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

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

Directory of Open Access Journals (Sweden)

James E. Peterman

2015-08-01

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

Implications of HIV PrEP Trials Results

Science.gov (United States)

Anton, Peter; Fletcher, Courtney V.; DeGruttola, Victor; McGowan, Ian; Becker, Stephen; Zwerski, Sheryl; Burns, David

2011-01-01

Abstract Six randomized clinical trials have been implemented to examine the efficacy of tenofovir disoproxil fumarate (TDF) and/or TDF/emtricitabine (TDF/FTC) as preexposure prophylaxis for HIV-1 infection (PrEP). Although largely complementary, the six trials have many similar features. As the earliest results become available, an urgent question may arise regarding whether changes should be made in the conduct of the other trials. To consider this in advance, a Consultation on the Implications of HIV Pre-Exposure Prophylaxis (PrEP) Trials Results sponsored by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and the Bill and Melinda Gates Foundation (BMGF) was held on January 29, 2010, at the Natcher Conference Center, NIH, Bethesda, MD. Participants included basic scientists, clinical researchers (including investigators performing the current PrEP trials), and representatives from the U.S. Food and Drug Administration (FDA) and the agencies sponsoring the trials: the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Agency for International Development (USAID), the BMGF, and the U.S. NIH. We report here a summary of the presentations and highlights of salient discussion topics from this workshop. PMID:20969483

US genetic regulations: bacterial field trial to go ahead.

Science.gov (United States)

Budiansky, S

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

Evaluation of field trials of innovative practices in science education

OpenAIRE

Gerloff-Gasser, C; Büchel, K

2012-01-01

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

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

NARCIS (Netherlands)

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

2018-01-01

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

Field Trial of the Enhanced Data Authentication System (EDAS)

Energy Technology Data Exchange (ETDEWEB)

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

2016-05-01

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

Phytoremediation prospects of willow stands on contaminated sediment: a field trial

International Nuclear Information System (INIS)

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

2003-01-01

A field trial indicated increased degradation of mineral oil in sediments planted with willow. - Establishing fast growing willow stands on land disposed contaminated dredged sediment can result in the revaluation of this material and opens possibilities for phytoremediation. A field trial was designed to assess the impact of planting a willow stand (Salix viminalis L. 'Orm') on the dissipation of organic contaminants (mineral oil and PAHs) in dredged sediment. In addition, the accumulation of heavy metals (Cd, Cu, Pb and Zn) in the biomass was determined. After 1.5 years, a significant decrease of 57% in the mineral oil concentration in the sediment planted with willow was observed. Degradation of mineral oil in sediment which was left fallow, was only 15%. The mineral oil degradation under willow was most pronounced (79%) in the root zone of the stand. In the sediment which was left fallow there was a significant reduction of the total PAH content by 32% compared with a 23% reduction in the planted sediment. The moderate and selective metal uptake, measured in this study, limits the prospects for phytoextraction of metals from dredged sediment

Phytoremediation prospects of willow stands on contaminated sediment: a field trial

Energy Technology Data Exchange (ETDEWEB)

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

2003-11-01

A field trial indicated increased degradation of mineral oil in sediments planted with willow. - Establishing fast growing willow stands on land disposed contaminated dredged sediment can result in the revaluation of this material and opens possibilities for phytoremediation. A field trial was designed to assess the impact of planting a willow stand (Salix viminalis L. 'Orm') on the dissipation of organic contaminants (mineral oil and PAHs) in dredged sediment. In addition, the accumulation of heavy metals (Cd, Cu, Pb and Zn) in the biomass was determined. After 1.5 years, a significant decrease of 57% in the mineral oil concentration in the sediment planted with willow was observed. Degradation of mineral oil in sediment which was left fallow, was only 15%. The mineral oil degradation under willow was most pronounced (79%) in the root zone of the stand. In the sediment which was left fallow there was a significant reduction of the total PAH content by 32% compared with a 23% reduction in the planted sediment. The moderate and selective metal uptake, measured in this study, limits the prospects for phytoextraction of metals from dredged sediment.

Publication and non-publication of drug trial results: a 10-year cohort of trials in Norwegian general practice.

Science.gov (United States)

Brænd, Anja Maria; Straand, Jørund; Jakobsen, Rune Bruhn; Klovning, Atle

2016-04-11

Previously, we identified a 10-year cohort of protocols from applications to the Norwegian Medicines Agency 1998-2007, consisting of 196 drug trials in general practice. The aim of this study was to examine whether trial results were published and whether trial funding and conflicts of interest were reported. Cohort study of trials with systematic searches for published results. Clinical drug trials in Norwegian general practice. We performed systematic literature searches of MEDLINE, Embase and CENTRAL to identify publications originating from each trial using characteristics such as test drug, comparator and patient groups as search terms. When no publication was identified, we contacted trial sponsors for information regarding trial completion and reference to any publications. We determined the frequency of publication of trial results and trial characteristics associated with publication of results. Of the 196 trials, 5 were never started. Of the remaining 191 trials, 71% had results published in a journal, 11% had results publicly available elsewhere and 18% of trials had no results available. Publication was more common among trials with an active comparator drug (χ(2) test, p=0.040), with a larger number of patients (total sample size≥median, p=0.010) and with a longer trial period (duration≥median, p=0.025). Trial funding was reported in 85% of publications and increased over time, as did reporting of conflicts of interest among authors. Among the 134 main journal articles from the trials, 60% presented statistically significant results for the investigational drug, and the conclusion of the article was favourable towards the test drug in 78% of papers. We did not identify any journal publication of results for 29% of the general practice drug trials. Trials with an active comparator, larger and longer trials were more likely to be published. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a

Annual technical report. PV domestic field trial

Energy Technology Data Exchange (ETDEWEB)

NONE

2002-07-01

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

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

Science.gov (United States)

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

2011-01-01

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

[Maraviroc: clinical trials results].

Science.gov (United States)

Chidiac, C; Katlama, C; Yeni, P

2008-03-01

Just over a decade after identification of chemokine receptors CCR5 and CXCR4 as coreceptors for HIV, maraviroc (Celsentri), the first CCR5 antagonist, has recently obtained its Marketing Authorization in the United States and Europe, for treatment of treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable. CCR5 antagonists, after fusion inhibitor enfuvirtide available since 2003, also belong to entry inhibitors. These molecules, unlike previous antiretrovirals, do not target the virus but its target cell by blocking viral penetration. Maraviroc has shown its clinical efficacy in patients failing other antiretroviral classes. Its safety profile was similar to placebo in two large phase III trials. However, careful assessment of both hepatic and immunologic safety of this new therapeutic class is needed. Viral tropism testing has to be investigated before using maraviroc in the clinic, because CCR5 antagonists are not active against CXCR4 viruses. For the moment indicated for the treatment-experienced patient population, maraviroc could in the future benefit to other types of patients, depending on ongoing trials results.

Understanding the fate of black (pyrogenic) carbon in soil: Preliminary results from a long term field trial

Science.gov (United States)

Meredith, Will; Ascough, Philippa; Bird, Michael; Large, David; Shen, Licheng; Snape, Colin

2014-05-01

Black carbon (BC, also known as pyrogenic carbon) is an 'inert' form of carbon and has been proposed as a means of long-term carbon sequestration, particularly by amending soils and sediments with BC known as biochar. While there is abundant anecdotal evidence of biochar stability over extended timescales it is essential to gain a greater understanding of the degree and mechanisms of biochar degradation in the environment. This study aims to quantitatively assess the stability of biochar by investigating samples from field degradation trials first buried during 2009 in a tropical soil, and recovered after 12 and 36 month intervals. Catalytic hydropyrolysis (HyPy) is a novel analytical tool for the isolation of BC [1] in which high hydrogen pressure (150 bar) and a sulphided Mo catalyst reductively remove the non-BC fraction of the chars, and so isolate the most stable portion of the biochar, defined as BC(HyPy). This method also allows for the non-BC(HyPy) fraction of a sample, which from charcoal is known to include small ring PAHs (soil depth and pH to be investigated. Char stability (as measured by BC(HyPy) content) is dependent on both the feedstock and temperature of formation. HyPy is known to discriminate (in terms of BC isolation) against low temperature chars, composed of relatively small aromatic clusters [1], resulting in the low BC(HyPy) contents reported for the 305°C chars. Fresh charcoals, and those not subject to environmental degradation have display a similar distribution of aromatic clusters in the non-BC(HyPy) fraction, with 2 to 7 ring PAHs abundant [2]. However, environmentally degraded charcoals such as that from a Chinese river sediment, and an Australian river estuary [3] show a more restricted distribution with markedly fewer 2- and 3- ring PAH structures apparent. This may be evidence for the partial solubilisation of the charcoal as observed for a forest soil [4] and suggested as a mechanism for the transport of BC to the oceans [5

Design and field results of a walk-through EDS

Science.gov (United States)

Wendel, Gregory J.; Bromberg, Edward E.; Durfee, Memorie K.; Curby, William A.

1997-01-01

A walk-through portal sampling module which incorporates active sampling has been developed. The module uses opposing wands which actively brush the subjects exterior clothing to disturb explosive traces. These traces are entrained in an air stream and transported to a High Speed GC- chemiluminescence explosives detection system. This combination provides automatic screening of passengers at rates of 10 per minute. The system exhibits sensitivity and selectivity which equals or betters that available from commercially available manual equipment. The systems has been developed for deployment at border crossings, airports and other security screening points. Detailed results of laboratory tests and airport field trials are reviewed.

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

Science.gov (United States)

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

2018-03-05

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

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

International Nuclear Information System (INIS)

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

2013-01-01

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

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

Science.gov (United States)

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

2007-03-01

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

Transparency in ovarian cancer clinical trial results: ClinicalTrials.gov versus PubMed, Embase and Google scholar.

Science.gov (United States)

Roberto, Anna; Radrezza, Silvia; Mosconi, Paola

2018-04-10

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 ClinicalTrials.gov, and the frequency of non-publication of results in ClinicalTrials.gov and in PubMed, Embase and Google Scholar. We collected all trials on ovarian cancer identified as "completed status" in the ClinicalTrials.gov registry on 17 January 2017. We checked the availability of the results in ClinicalTrials.gov 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 ClinicalTrials.gov 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.

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

NARCIS (Netherlands)

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

2017-01-01

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

Distributed acoustic sensing technique and its field trial in SAGD well

Science.gov (United States)

Han, Li; He, Xiangge; Pan, Yong; Liu, Fei; Yi, Duo; Hu, Chengjun; Zhang, Min; Gu, Lijuan

2017-10-01

Steam assisted gravity drainage (SAGD) is a very promising way for the development of heavy oil, extra heavy oil and tight oil reservoirs. Proper monitoring of the SAGD operations is essential to avoid operational issues and improve efficiency. Among all the monitoring techniques, micro-seismic monitoring and related interpretation method can give useful information about the steam chamber development and has been extensively studied. Distributed acoustic sensor (DAS) based on Rayleigh backscattering is a newly developed technique that can measure acoustic signal at all points along the sensing fiber. In this paper, we demonstrate a DAS system based on dual-pulse heterodyne demodulation technique and did field trial in SAGD well located in Xinjiang Oilfield, China. The field trail results validated the performance of the DAS system and indicated its applicability in steam-chamber monitoring and hydraulic monitoring.

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

NARCIS (Netherlands)

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

2017-01-01

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

Field trials of aquifer protection in longwall mining of shallow coal seams in China

Energy Technology Data Exchange (ETDEWEB)

Zhang, D.S.; Fan, G.W.; Liu, Y.D.; Ma, L.Q. [State Key Laboratory of Coal Resource & Mine Safety, Xuzhou (China)

2010-09-15

The large-scale mining of shallow coal seams has a significant impact on the overlying aquifers and surface ecological environment. To protect the aquifers and maximize the coal resource recovery, field trials were undertaken during the operation of the LW32201 in Bulianta coal mine, Shendong, China. With a severely weathered rock (SWR) layer and two key strata (KS) in the overlying strata, aquifer protection in longwall mining (APLM) relies mainly on the rapid advance. In some localized zones, special measures should be taken to achieve the APLM, including lowering mining height, backfill and slurry injection. To further understand the mechanism and applicable conditions of the APLM and validate the effectiveness of the APLM, variation of the water table in the aquifer was observed as the longwall face passed through the zone. This paper also discusses the mechanism and basic requirements of the APLM and the relationship between the fall of the water table and the surface subsidence. The results of the field trials indicated that APLM in shallow coal seams could be successful under suitable conditions.

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

Science.gov (United States)

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

2016-09-01

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

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

NARCIS (Netherlands)

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

2015-01-01

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

The impact of farmers’ participation in field trials in creating awareness and stimulating compliance with the World Health Organization’s farm-based multiple-barrier approach

DEFF Research Database (Denmark)

Amponsah, Owusu; Vigre, Håkan; Schou, Torben Wilde

2016-01-01

-barrier approach field trials. The results of the study show that participation in the field trials has statistically significant effects on farmers’ awareness of the farm-based multiple-barrier approach. Compliance has, however, been undermined by the farmers’ perception that the cost of compliance is more......The results of a study aimed as assessing the extent to which urban vegetable farmers’ participation in field trials can impact on their awareness and engender compliance with the World Health Organization’s farm-based multiple-barrier approach are presented in this paper. Both qualitative...... and quantitative approaches have been used in this paper. One hundred vegetable farmers and four vegetable farmers’ associations in the Kumasi Metropolis in Ghana were covered. The individual farmers were grouped into two, namely: (1) participants and (2) non-participants of the farm-based multiple...

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

2012-08-15

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.)

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

Science.gov (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

2012-08-01

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.

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

Science.gov (United States)

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

2016-02-01

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

The TrialsTracker: Automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions.

Science.gov (United States)

Powell-Smith, Anna; Goldacre, Ben

2016-01-01

Background : Failure to publish trial results is a prevalent ethical breach with a negative impact on patient care. Audit is an important tool for quality improvement. We set out to produce an online resource that automatically identifies the sponsors with the best and worst record for failing to share trial results. Methods: A tool was produced that identifies all completed trials from clinicaltrials.gov, searches for results in the clinicaltrials.gov registry and on PubMed, and presents summary statistics for each sponsor online. Results : The TrialsTracker tool is now available. Results are consistent with previous publication bias cohort studies using manual searches. The prevalence of missing studies is presented for various classes of sponsor. All code and data is shared. Discussion: We have designed, built, and launched an easily accessible online service, the TrialsTracker, that identifies sponsors who have failed in their duty to make results of clinical trials available, and which can be maintained at low cost. Sponsors who wish to improve their performance metrics in this tool can do so by publishing the results of their trials.

Large-scale building integrated photovoltaics field trial. First technical report - installation phase

Energy Technology Data Exchange (ETDEWEB)

NONE

2004-07-01

This report summarises the results of the first eighteen months of the Large-Scale Building Integrated Photovoltaic Field Trial focussing on technical aspects. The project aims included increasing awareness and application of the technology, raising the UK capabilities in application of the technology, and assessing the potential for building integrated photovoltaics (BIPV). Details are given of technology choices; project organisation, cost, and status; and the evaluation criteria. Installations of BIPV described include University buildings, commercial centres, and a sports stadium, wildlife park, church hall, and district council building. Lessons learnt are discussed, and a further report covering monitoring aspects is planned.

Demonstration and field trial of a resilient hybrid NG-PON test-bed

Science.gov (United States)

Prat, Josep; Polo, Victor; Schrenk, Bernhard; Lazaro, Jose A.; Bonada, Francesc; Lopez, Eduardo T.; Omella, Mireia; Saliou, Fabienne; Le, Quang T.; Chanclou, Philippe; Leino, Dmitri; Soila, Risto; Spirou, Spiros; Costa, Liliana; Teixeira, Antonio; Tosi-Beleffi, Giorgio M.; Klonidis, Dimitrios; Tomkos, Ioannis

2014-10-01

A multi-layer next generation PON prototype has been built and tested, to show the feasibility of extended hybrid DWDM/TDM-XGPON FTTH networks with resilient optically-integrated ring-trees architecture, supporting broadband multimedia services. It constitutes a transparent common platform for the coexistence of multiple operators sharing the optical infrastructure of the central metro ring, passively combining the access and the metropolitan network sections. It features 32 wavelength connections at 10 Gbps, up to 1000 users distributed in 16 independent resilient sub-PONs over 100 km. This paper summarizes the network operation, demonstration and field trial results.

A low-cost repellent for malaria vectors in the Americas: results of two field trials in Guatemala and Peru

Directory of Open Access Journals (Sweden)

Sihuincha Moisés

2007-08-01

Full Text Available Abstract Background The cost of mosquito repellents in Latin America has discouraged their wider use among the poor. To address this problem, a low-cost repellent was developed that reduces the level of expensive repellent actives by combining them with inexpensive fixatives that appear to slow repellent evaporation. The chosen actives were a mixture of para-menthane-diol (PMD and lemongrass oil (LG. Methods To test the efficacy of the repellent, field trials were staged in Guatemala and Peru. Repellent efficacy was determined by human-landing catches on volunteers who wore the experimental repellents, control, or 15% DEET. The studies were conducted using a balanced Latin Square design with volunteers, treatments, and locations rotated each night. Results In Guatemala, collections were performed for two hours, commencing three hours after repellent application. The repellent provided >98% protection for five hours after application, with a biting pressure of >100 landings per person/hour. The 15% DEET control provided lower protection at 92% (p 46 landings per person/hour. The 20% DEET control provided significantly lower protection at 64% (p Conclusion In both locations, the PMD/LG repellent provided excellent protection up to six hours after application against a wide range of disease vectors including Anopheles darlingi. The addition of fixatives to the repellent extended its longevity while enhancing efficacy and significantly reducing its cost to malaria-endemic communities.

Analysis of the PISC II trials results

International Nuclear Information System (INIS)

Haines, N.

1988-01-01

The paper presents the analysis scheme of the Programme for the Inspection of Steel Components PISC II trial results. The objective of the PISC II exercise is to evaluate the effectiveness of current and advanced NDT techniques for inspection of reactor pressure vessel components. The analysis scheme takes data from the Round Robin Trial (RRT) and Destructive Examination, then reduces it to a manageable form in order to present useful conclusions on the effectiveness of NDT. A description is given of the data provided by RRT, the data analysis scheme, the definition of analysis parameters, and the main methods of data presentation. (U.K.)

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

Data.gov (United States)

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

Passive drainage and biofiltration of landfill gas: Australian field trial

International Nuclear Information System (INIS)

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

2007-01-01

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

An unattended verification station for UF6 cylinders: Field trial findings

Science.gov (United States)

Smith, L. E.; Miller, K. A.; McDonald, B. S.; Webster, J. B.; Zalavadia, M. A.; Garner, J. R.; Stewart, S. L.; Branney, S. J.; Todd, L. C.; Deshmukh, N. S.; Nordquist, H. A.; Kulisek, J. A.; Swinhoe, M. T.

2017-12-01

In recent years, the International Atomic Energy Agency (IAEA) has pursued innovative techniques and an integrated suite of safeguards measures to address the verification challenges posed by the front end of the nuclear fuel cycle. Among the unattended instruments currently being explored by the IAEA is an Unattended Cylinder Verification Station (UCVS), which could provide automated, independent verification of the declared relative enrichment, 235U mass, total uranium mass, and identification for all declared uranium hexafluoride cylinders in a facility (e.g., uranium enrichment plants and fuel fabrication plants). Under the auspices of the United States and European Commission Support Programs to the IAEA, a project was undertaken to assess the technical and practical viability of the UCVS concept. The first phase of the UCVS viability study was centered on a long-term field trial of a prototype UCVS system at a fuel fabrication facility. A key outcome of the study was a quantitative performance evaluation of two nondestructive assay (NDA) methods being considered for inclusion in a UCVS: Hybrid Enrichment Verification Array (HEVA), and Passive Neutron Enrichment Meter (PNEM). This paper provides a description of the UCVS prototype design and an overview of the long-term field trial. Analysis results and interpretation are presented with a focus on the performance of PNEM and HEVA for the assay of over 200 "typical" Type 30B cylinders, and the viability of an "NDA Fingerprint" concept as a high-fidelity means to periodically verify that material diversion has not occurred.

Field Trial Measurements to Validate a Stochastic Aircraft Boarding Model

Directory of Open Access Journals (Sweden)

Michael Schultz

2018-03-01

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

True fir spacing trials: 10-year results.

Science.gov (United States)

Robert O. Curtis

2008-01-01

Eighteen precommercial thinning trials were established in true fir-hemlock stands in the Olympic Mountains and the west side of the Cascade Range during the period 1987 through 1994. This paper updates a previous report, with results for the first 10 years after establishment. Results are given for (1) all trees, (2) the largest 80 per acre of any species, and (3)...

Disseminating results to clinical trial participants: a qualitative review of patient understanding in a post-trial population.

Science.gov (United States)

Darbyshire, Julie Lorraine; Price, Hermione Clare

2012-01-01

To identify the most appropriate format for results dissemination to maximise understanding of trial results. Qualitative. Of the original 58 4-T trial centres, 34 agreed to take part in this ancillary research. All participants from these centres were eligible. All 343 participants were sent questionnaires. The low response rate meant that we were unable to make any firm conclusions about the patients' preferred method of dissemination; however, we were able to comment on the level of understanding demonstrated by the trial participants. All 40 (12%) returned questionnaires were received from 15 centres. We received no questionnaires from over half of the centres. The questionnaires which were returned demonstrated broad satisfaction with the results letter, general enthusiasm for the trial and a variable level of understanding of the results; however, there was a high proportion of responders who were not clear on why the research was undertaken or what the results meant. The low response rate may be related to delays during the trial set-up process suggesting that interest in a study quickly wanes for both patients and centres. From this we deduce that rapid dissemination of results is needed if it is to have any impact at all. The responders are likely to reflect a biased cohort who were both enthusiastic about the research and who had a good experience during their 3 years in the 4-T trial. It is perhaps not surprising therefore that the overview is positive. That this population was still not fully informed about the purpose of the research would seem to confirm a low level of understanding among the general public which we suggest should be addressed during the consent process.

Results from a Field Trial of the Radio Frequency Based Cylinder Accountability and Tracking System at the Global Nuclear Fuel Americas Fuel Fabrication Facility

International Nuclear Information System (INIS)

Fitzgerald, Peter; Laughter, Mark D.; Martyn, Rose; Pickett, Chris A.; Rowe, Nathan C.; Younkin, James R.; Shephard, Adam M.

2010-01-01

The Cylinder Accountability and Tracking System (CATS) is a tool designed for use by the International Atomic Energy Agency (IAEA) to improve overall inspector efficiency through real-time unattended monitoring of cylinder movements, site specific rules-based event detection, and the capability to integrate many types of monitoring technologies. The system is based on the tracking of cylinder movements using (radio frequency) RF tags, and the collection of data, such as accountability weights, that can be associated with the cylinders. This presentation will cover the installation and evaluation of the CATS at the Global Nuclear Fuels (GNF) fuel fabrication facility in Wilmington, NC. This system was installed to evaluate its safeguards applicability, operational durability under operating conditions, and overall performance. An overview of the system design and elements specific to the GNF deployment will be presented along with lessons learned from the installation process and results from the field trial.

Field trial of a pulsed limestone diversion well

Science.gov (United States)

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

2013-01-01

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

Note on field trials of a new prototype solar still

Energy Technology Data Exchange (ETDEWEB)

Anand, S P

1977-01-01

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

Pyrolysis of attapulgite clay blended with yak dung enhances pasture growth and soil health: Characterization and initial field trials.

Science.gov (United States)

Rafiq, Muhammad Khalid; Joseph, Stephen D; Li, Fei; Bai, Yanfu; Shang, Zhanhuan; Rawal, Aditya; Hook, James M; Munroe, Paul R; Donne, Scott; Taherymoosavi, Sara; Mitchell, David R G; Pace, Ben; Mohammed, Mohanad; Horvat, Joseph; Marjo, Christopher E; Wagner, Avital; Wang, Yanlong; Ye, Jun; Long, Rui-Jun

2017-12-31

Recent studies have shown that the pyrolysis of biomass combined with clay can result in both lower cost and increase in plant yields. One of the major sources of nutrients for pasture growth, as well as fuel and building materials in Tibet is yak dung. This paper reports on the initial field testing in a pasture setting in Tibet using yak dung, biochar, and attapulgite clay/yak dung biochars produced at ratios of 10/90 and 50/50 clay to dung. We found that the treatment with attapulgite clay/yak dung (50/50) biochar resulted in the highest pasture yields and grass nutrition quality. We also measured the properties and yields of mixtures of clay/yak dung biochar used in the field trials produced at 400°C and 500°C to help determine a possible optimum final pyrolysis temperature and dung/clay ratio. It was observed that increasing clay content increased carbon stability, overall biochar yield, pore size, carboxyl and ketone/aldehyde functional groups, hematite and ferrous/ferric sulphate/thiosulphate concentration, surface area and magnetic moment. Decreasing clay content resulted in higher pH, CEC, N content and an enhanced ability to accept and donate electrons. The resulting properties were a complex function of both processing temperature and the percentage of clay for the biochars processed at both 400°C and 500°C. It is possible that the increase in yield and nutrient uptake in the field trial is related to the higher concentration of C/O functional groups, higher surface area and pore volume and higher content of Fe/O/S nanoparticles of multiple oxidation state in the 50/50 clay/dung. These properties have been found to significantly increase the abundance of beneficial microorganisms and hence improve the nutrient cycling and availability in soil. Further field trials are required to determine the optimum pyrolysis production conditions and application rate on the abundance of beneficial microorganisms, yields and nutrient quality. Copyright © 2017

Field trial using bone meal amendments to remediate mine waste derived soil contaminated with zinc, lead and cadmium

International Nuclear Information System (INIS)

Sneddon, I.R.; Orueetxebarria, M.; Hodson, M.E.; Schofield, P.F.; Valsami-Jones, E.

2008-01-01

Bone meal amendments are being considered as a remediation method for metal-contaminated wastes. In various forms (biogenic, geogenic or synthetic), apatite, the principal mineral constituent of bone, has shown promise as an amendment to remediate metal-contaminated soils via the formation of insoluble phosphates of Pb and possibly other metals. The efficacy of commercially available bovine bone meal in this role was investigated in a field trial at Nenthead, Cumbria with a mine waste derived soil contaminated with Zn, Pb and Cd. Two 5 m 2 plots were set up; the first as a control and the second, a treatment plot where the soil was thoroughly mixed with bone meal to a depth of 50 cm at a soil to amendment ratio of 25:1 by weight. An array of soil solution samplers (Rhizon SMS TM ) were installed in both plots and the soil pore water was collected and analysed for Ca, Cd, Zn and Pb regularly over a period of 2 a. Concurrently with the field trial, a laboratory trial with 800 mm high and 100 mm wide leaching columns was conducted using identical samplers and with soil from the field site. A substantial release of Zn, Pb, Cd and Ca was observed associated with the bone meal treatment. This release was transient in the case of the leaching columns, and showed seasonal variation in the case of the field trial. It is proposed that this effect resulted from metal complexation with organic acids released during breakdown of the bone meal organic fraction and was facilitated by the relatively high soil pH of 7.6-8.0. Even after this transient release effect had subsided or when incinerated bone meal was substituted in order to eliminate the organic fraction, no detectable decrease in dissolved metals was observed and no P was detected in solution, in contrast with an earlier small column laboratory study. It is concluded that due to the relative insolubility of apatite at above-neutral pH, the rate of supply of phosphate to soil solution was insufficient to result in

Screening of willow species for resistance to heavy metals: comparison of performance in a hydroponics system and field trials.

Science.gov (United States)

Watson, C; Pulford, I D; Riddell-Black, D

2003-01-01

The aim of this study was to ascertain whether metal resistance in willow (Salix) clones grown in a hydroponics screening test correlated with data from the same clones grown independently in a field trial. If so, results from a short-term, glasshouse-based system could be extrapolated to the field, allowing rapid identification of willows suitable for planting in metal-contaminated substrates without necessitating longterm field trials. Principal Components Analysis was used to show groups of clones and to assess the relative importance of the parameters measured in both the hydroponics system and the field; including plant response factors such as increase in stem height, as well as metal concentrations in plant tissues. The clones tested fell into two distinct groups. Salix viminalis clones and the basket willow Black Maul (S. triandra) were less resistant to elevated concentrations of heavy metals than a group of hardier clones, including S. burjatica 'Germany,' S.x dasyclados, S. candida and S. spaethii. The more resistant clones produced more biomass in the glasshouse and field, and had higher metal concentrations in the wood. The less resistant clones had greater concentrations of Cu and Ni in the bark, and produced less biomass in the glasshouse and field. Significant relationships were found between the response of the same clones grown the in short-term glasshouse hydroponics system and in the field.

Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial.

Science.gov (United States)

Maruani, Annabel; Boutron, Isabelle; Baron, Gabriel; Ravaud, Philippe

2014-09-19

To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation, to remind them of the legal requirement to post results. Cohort embedded pragmatic randomized controlled trial. Trials registered on ClinicalTrials.gov. 190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention (personalized emails structured as a survey and sent by one of us to responsible parties of the trials, indirectly reminding them of the legal requirement and potential penalties for non-compliance). The primary outcome was the proportion of results posted on ClinicalTrials.gov at three months. The secondary outcome was the proportion posted at six months. In a second step, two assessors blinded to the intervention group collected the date of the first results being received on ClinicalTrials.gov. A post hoc sensitivity analysis excluding trials wrongly included was performed. Among 379 trials included, 190 were randomized to receive the email intervention. The rate of posting of results did not differ at three months between trials with or without the intervention: 36/190 (19%) v 24/189 (13%), respectively (relative risk 1.5, 95% confidence interval 0.9 to 2.4, P=0.096) but did at six months: 46/190 (24%) v 27/189 (14%), 1.7, 1.1 to 2.6, P=0.014. In the sensitivity analysis, which excluded 48/379 trials (13%), 26/190 (14%) and 22/189 (12%), respectively, results were significant at three months (relative risk 5.1, 1.1 to 22.9, P=0.02) and at six months (4.1, 1.3 to 10.6, P=0.001). Sending email reminders about the FDA's legal requirement to post results at ClinicalTrials.gov improved significantly the posting rate at six months but not at three months.Trial registration ClinicalTrials.gov NCT01658254. © Maruani et al 2014.

Results of an Oncology Clinical Trial Nurse Role Delineation Study.

Science.gov (United States)

Purdom, Michelle A; Petersen, Sandra; Haas, Barbara K

2017-09-01

To evaluate the relevance of a five-dimensional model of clinical trial nursing practice in an oncology clinical trial nurse population. 
. Web-based cross-sectional survey.
. Online via Qualtrics.
. 167 oncology nurses throughout the United States, including 41 study coordinators, 35 direct care providers, and 91 dual-role nurses who provide direct patient care and trial coordination.
. Principal components analysis was used to determine the dimensions of oncology clinical trial nursing practice.
. Self-reported frequency of 59 activities.
. The results did not support the original five-dimensional model of nursing care but revealed a more multidimensional model.
. An analysis of frequency data revealed an eight-dimensional model of oncology research nursing, including care, manage study, expert, lead, prepare, data, advance science, and ethics.
. This evidence-based model expands understanding of the multidimensional roles of oncology nurses caring for patients with cancer enrolled in clinical trials.

Reducing Reforestation Costs in Lebanon: Adaptive Field Trials

Directory of Open Access Journals (Sweden)

Garabet (Garo Haroutunian

2017-05-01

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

Patient engagement in clinical trials: The Clinical Trials Transformation Initiative's leadership from theory to practical implementation.

Science.gov (United States)

Patrick-Lake, Bray

2018-02-01

Patient engagement is an increasingly important aspect of successful clinical trials. Over the past decade, as patient group involvement in clinical trials has continued to increase and diversify, the Clinical Trials Transformation Initiative has not only recognized the crucial role patients play in improving the clinical trial enterprise but also made a deep commitment to help grow and shape the emerging field of patient engagement. This article describes the evolution of patient engagement including the origins of the patient engagement movement; barriers to successful engagement and remaining challenges to full and valuable collaboration between patient groups and trial sponsors; and Clinical Trials Transformation Initiative's role in influencing the field through organizational practices, formal project work and resulting recommendations, and external advocacy efforts.

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

Directory of Open Access Journals (Sweden)

Ulber, Lena

2016-02-01

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

Primary HPV screening for cervical cancer prevention: results from European trials

DEFF Research Database (Denmark)

Lynge, Elsebeth; Rebolj, Matejka

2009-01-01

testing increased the detection of cervical intraepithelial neoplasia (CIN) grade 2+. Detection of CIN3+ was significantly increased in two trials (relative risks [RRs] 1.70 and 2.26), but not in three other trials (RRs 1.03, 1.09 and 1.31). In three trials, seven extra women had a false-positive test......Six European, randomized, controlled trials that will compare human papillomavirus (HPV) testing with cytological testing for cervical screening are under way. We reviewed the results published so far to compare the benefits and costs for participating women. At baseline screening, use of HPV...

Initial Field Trial of a Coach-Supported Web-Based Depression Treatment.

Science.gov (United States)

Schueller, Stephen M; Mohr, David C

2015-08-01

Early web-based depression treatments were often self-guided and included few interactive elements, instead focusing mostly on delivering informational content online. Newer programs include many more types of features. As such, trials should analyze the ways in which people use these sites in order to inform the design of subsequent sites and models of support. The current study describes of a field trial consisting of 9 patients with major depressive disorder who completed a 12-week program including weekly coach calls. Patients usage varied widely, however, patients who formed regular patterns tended to persist with the program for the longest. Future sites might be able to facilitate user engagement by designing features to support regular use and to use coaches to help establish patterns to increase long-term use and benefit.

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

International Nuclear Information System (INIS)

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

2013-01-01

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

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

Science.gov (United States)

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

2018-04-01

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

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

NARCIS (Netherlands)

René Bakker; Koen van Turnhout; Jasper Jeurens

2014-01-01

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

Conducting field trials for frost tolerance breeding in cereals.

Science.gov (United States)

Cattivelli, Luigi

2014-01-01

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

Bone metastasis: review and critical analysis of random allocation trials of local field treatment

International Nuclear Information System (INIS)

Ratanatharathorn, Vaneerat; Powers, William E.; Moss, William T.; Perez, Carlos A.

1999-01-01

Purpose: Compare and contrast reports of random allocation clinical trials of local field radiation therapy of metastases to bone to determine the techniques producing the best results (frequency, magnitude, and duration of benefit), and relate these to the goals of complete relief of pain and prevention of disability for the remaining life of the patient. Methods and Materials: Review all published reports of random allocation clinical trials, and perform a systematic analysis of the processes and outcomes of the several trial reports. Results: All trials were performed on selected populations of patients with symptomatic metastases and most studies included widely diverse groups with regard to: (a) site of primary tumor, (b) location, extent, size, and nature of metastases, (c) duration of survival after treatment. All trial reports lack sufficient detail for full and complete analysis. Much collected information is not now available for reanalysis and many important data sets were apparently never collected. Several of the variations in patient and tumor characteristics were found to be much more important than treatment dose in the outcome results. Treatment planning and delivery techniques were unsophisticated and probably resulted in a systematic delivery of less than the assigned dose to some metastases. In general the use and benefit of retreatment was greater in those patients who initially received lower doses but the basis and dose of retreatment was not documented. Follow-up of patients was varied with a large proportion of surviving patients lost to follow-up in several studies. The greatest difference in the reports is the method of calculation of results. The applicability of Kaplan-Meier actuarial analysis, censoring the lost and dead patients, as used in studies with loss to follow-up of a large number of patients is questionable. The censoring involved is 'informative' (the processes of loss relate to the outcome) and not acceptable since it

Pharmaceutical companies' policies on access to trial data, results, and methods: audit study.

Science.gov (United States)

Goldacre, Ben; Lane, Síle; Mahtani, Kamal R; Heneghan, Carl; Onakpoya, Igho; Bushfield, Ian; Smeeth, Liam

2017-07-26

Objectives  To identify the policies of major pharmaceutical companies on transparency of trials, to extract structured data detailing each companies' commitments, and to assess concordance with ethical and professional guidance. Design  Structured audit. Setting  Pharmaceutical companies, worldwide. Participants  42 pharmaceutical companies. Main outcome measures  Companies' commitments on sharing summary results, clinical study reports (CSRs), individual patient data (IPD), and trial registration, for prospective and retrospective trials. Results  Policies were highly variable. Of 23 companies eligible from the top 25 companies by revenue, 21 (91%) committed to register all trials and 22 (96%) committed to share summary results; however, policies commonly lacked timelines for disclosure, and trials on unlicensed medicines and off-label uses were only included in six (26%). 17 companies (74%) committed to share the summary results of past trials. The median start date for this commitment was 2005. 22 companies (96%) had a policy on sharing CSRs, mostly on request: two committed to share only synopses and only two policies included unlicensed treatments. 22 companies (96%) had a policy to share IPD; 14 included phase IV trials (one included trials on unlicensed medicines and off-label uses). Policies in the exploratory group of smaller companies made fewer transparency commitments. Two companies fell short of industry body commitments on registration, three on summary results. Examples of contradictory and ambiguous language were documented and summarised by theme. 23/42 companies (55%) responded to feedback; 7/1806 scored policy elements were revised in light of feedback from companies (0.4%). Several companies committed to changing policy; some made changes immediately. Conclusions  The commitments made by companies to transparency of trials were highly variable. Other than journal submission for all trials within 12 months, all elements of best practice

Phytostabilization of a Pb-contaminated mine tailing by various tree species in pot and field trial experiments.

Science.gov (United States)

Meeinkuirt, Weeradej; Pokethitiyook, Prayad; Kruatrachue, Maleeya; Tanhan, Phanwimol; Chaiyarat, Rattanawat

2012-10-01

The potential of 6 tree species (Leucaena leucocephala, Acacia mangium, Peltophorum pterocarpum, Pterocarpus macrocarpus, Lagerstroemia floribunda, Eucalyptus camaldulensis) for phytoremediation of Pb in sand tailings (total Pb >9850 mg kg(-1)) from KEMCO Pb mine in Kanchanaburi province, Thailand, were investigated employing a pot experiment (3 months) and field trial experiment (12 months). In pot study E. camaldulensis treated with Osmocote fertilizer attained the highest total biomass (15.3 g plant(-1)) followed by P. pterocarpum (12.6 g plant(-1)) and A. mangium (10.8 g plant(-1)) both treated with cow manure. Cow manure application resulted in the highest root Pb accumulation (>10000 mg kg(-1)) in L. floribunda and P. macrocarpus. These two species also exhibited the highest Pb uptake (85-88 mg plant(-1)). Results from field trial also showed that Osmocote promoted the best growth performance in E. camaldulensis (biomass 385.7 g plant(-1), height 141.7 cm) followed by A. mangium (biomass 215.9 g plant(-1), height 102.7 cm), and they also exhibited the highest Pb uptake (600-800 microg plant(-1)). A. mangium with the addition of organic fertilizer was the best option for phytostabilization of Pb-contaminated mine tailing because it retained higher Pb concentration in the roots.

Field trials on the store dressing with rock phosphate

Directory of Open Access Journals (Sweden)

Pentti Hänninen

1960-01-01

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

Resultados experimentais com a cultura da Crotalaria juncea L. L., como planta produtora de celulose para papel Results from field trials with Crotalaria juncea L. as fiber plant for paper pulp

Directory of Open Access Journals (Sweden)

Júlio César Medina

1961-01-01

Full Text Available São apresentados e discutidos os resultados de vários experimentos de campo realizados na Estação Experimental de Tatuí, do Instituto Agronômico, com a Crotalaria juncea L. como planta produtora de celulose para papel. Êsses resultados permitem fazer recomendações úteis sôbre o melhoramento técnico da cultura e da produção, no concernente às questões de variedades, espaçamento, densidade de semeação, época de semeação e época de colheita dos caules.This paper reports the results obtained in sunn hemp (Crotalaria juncea L. field trials carried out at the Tatui Experiment Station, São Paulo State. The trials were designed to study the effect of varieties, spacing x rate of seeding, time of sowing and time of harvesting on sunn hemp fiber production as a raw material for paper pulp. From the results achieved in these trials, the following recommendations can be made for growing sunn hemp as a fiber plant for paper pulp in the State of São Paulo. VARIETY: to use the common variety that is normally sowed for green manuring. TIME OF SOWING: to sow the seeds during october. RATE OF SEED SOWING AND SPACING: to sow the seeds at the rate of 100 lbs/ acre in rows spaced 8 inches apart. TIME OF HARVESTING: to harvest the stalks for mechanical fiber extraction when the seed pods are in the mature stage.

Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions.

Directory of Open Access Journals (Sweden)

Stephanie Coronado-Montoya

Full Text Available A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified.CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses.108 (87% of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88% concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7. Of 21 trial registrations, 13 (62% remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases.The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice.

Characterization of a new fertilizer during field trials by hyperspectral imaging

Science.gov (United States)

Bonifazi, Giuseppe; Serranti, Silvia; Trella, Agata; Garcia Izquierdo, Carlos

2016-05-01

This work was carried out in the framework of the LIFE RESAFE Project (LIFE12 ENV/IT/000356) "Innovative fertilizer from urban waste, bio-char and farm residues as substitute of chemical fertilizers". The aim of RESAFE project is the production of a new fertilizer from waste for agricultural practices. The new fertilizer was tested on 5 different crops during field trials carried out in Spain: barley, corn, tomato, potato and melon. For each crop six different treatments were applied and compared to verify the quality of RESAFE fertilizer. Soil samples were collected at the beginning and at the end of the experiment. The possibility to apply hyperspectral imaging (HSI) to perform soil evolution monitoring and characterization in respect to the fertilizer utilization and quality of the resulting crops was investigated. Soil samples were acquired by HSI in the near infrared field (1000-1700 nm) and on the same samples classical chemical analyses were carried out with reference to total nitrogen, total organic carbon, C/N ratio, total organic matter. Hyperspectral data were analyzed adopting a chemometric approach through application of Principal Component Analysis (PCA) for exploratory purposes and Partial Least Squares Analysis (PLS) for estimation of chemical parameters. The results showed as the proposed hardware and software integrated architecture allows to implement low cost and easy to use analytical procedures able to quantitatively assess soil chemical-physical attributes according to different fertilization strategies, in respect of different environmental conditions and selected crops.

A randomized controlled trial of Human Papillomavirus (HPV testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial

Directory of Open Access Journals (Sweden)

Smith Laurie W

2010-03-01

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

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

National Research Council Canada - National Science Library

Fournier, Pierre

2002-01-01

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

Global health trials methodological research agenda:results from a priority setting exercise

OpenAIRE

Blazeby, Jane; Nasser, Mona; Soares-Weiser, Karla; Sydes, Matthew R.; Zhang, Junhua; Williamson, Paula R

2018-01-01

BackgroundMethodological research into the design, conduct, analysis and reporting of trials is essential to optimise the process. UK specialists in the field have established a set of top priorities in aid of this research. These priorities however may not be reflected in the needs of similar research in low to middle income countries (LMICs) with different healthcare provision, resources and research infrastructure. The aim of the study was to identify the top priorities for methodological ...

Chelation therapy after the Trial to Assess Chelation Therapy: results of a unique trial

Science.gov (United States)

Avila, Maria D.; Escolar, Esteban; Lamas, Gervasio A.

2014-01-01

Purpose of review EDTA chelation therapy has been in off-label use for the treatment of atherosclerosis. We review the results of the first large-scale randomized trial of this treatment. Recent findings The trial to assess chelation therapy was a $30 million National Institutes of Health-funded study of the safety and efficacy of EDTA-based chelation infusions in 1708 post-myocardial infarction (MI) patients. The trial to assess chelation therapy demonstrated a significant (P = 0.035) 18% reduction in a combined primary endpoint of death, MI, stroke, coronary revascularization, or hospitalization for angina. In diabetic patients the benefit was more extreme, with a 41% relative reduction in risk (P = 0.0002) and a 43% reduction in total mortality (P = 0.011). Safety data were favorable. A reduction of oxidative stress by chelation of toxic metals has been proposed as a possible mechanism of action. Summary Recent research suggests that EDTA chelation may be a well-tolerated and effective treatment for post-MI patients. Future replication and mechanistic studies are important prior to implementation in all post-MI patients. PMID:25023079

Trial of Engineer Educating of Manufacturing Field in Kagoshima National College of Technology

Science.gov (United States)

Nakamura, Itaru; Hombu, Mitsuyuki; Kusuhara, Yoshito; Kashine, Kenji; Sakasegawa, Eiichi; Tashima, Daisuke; Fukidome, Hiromi

In Kagoshima National College of Technology, based on investigation with “the job boost measure investigation work in a power supply area” undertaken in the 2005 fiscal year, we accepted the trust from Kyushu Bureau of Economy, Trade and Industry, and undertook “the small-and-medium-sized-enterprises personnel educating work which utilized the technical college etc.” for three years from the 2006 fiscal year to the 2008 fiscal year. As the trial of engineer educating according to the electrical engineering concept to the manufacturing field based on a conventional result, we act as a professor of the base technique for applying alternative energy (a fuel cell and a solar cell) in which social needs are powerful these days, and aim at aiming at cultivation of the problem-solving type engineer who can contribute to a low carbon society through manufacturing, we undertook this work according to the manufacturing bearer educating work (personnel educating and secured work of the manufacturing field) in the 2009 fiscal year of National Federation of Small Business Associations.

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

Data.gov (United States)

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

Molecular and risk-based approach to nutrient development for a proposed sub-surface biogasification field trial in a biogenic gas field

Energy Technology Data Exchange (ETDEWEB)

Lambo, Adewale J.; Strapoc, Dariusz; Pittenger, Michelle; Huizinga, Bradley [ConocoPhillips (Canada); Wood, Ladonna; Ashby, Matt [Taxon Biosciences (Canada)

2011-07-01

This paper presents the molecular and risk-based approach to nutrient development for a proposed sub-surface biogasification field trial in a biogenic gas field. From field sampling, variability was seen in water chemistry and environmental parameters across the field; DNA yield also varied across the field and showed distinct spatial variation. The composition of microbial populations and relative distribution of archaea populations in the Cooks Inlet water is represented using pie and bar charts. The nutrient recipe was developed using known information on nutrient requirements of mathematically correlated microbial associations. The process of on-site nutrient injection is explained. Some of the mitigation plans for the risks involved during the process include, among others, limiting biofilm prevalence and avoiding bio-plugging and bio-corrosion. Biofilm is likely to develop in the injection line but less likely in nutrient mixing due to the high nutrient concentration. From the study, it can be concluded that community composition correlates with field geochemical parameters and methane pathways.

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

Science.gov (United States)

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

2012-10-01

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

A cross-validation trial of an Internet-based prevention program for alcohol and cannabis: Preliminary results from a cluster randomised controlled trial.

Science.gov (United States)

Champion, Katrina E; Newton, Nicola C; Stapinski, Lexine; Slade, Tim; Barrett, Emma L; Teesson, Maree

2016-01-01

Replication is an important step in evaluating evidence-based preventive interventions and is crucial for establishing the generalizability and wider impact of a program. Despite this, few replications have occurred in the prevention science field. This study aims to fill this gap by conducting a cross-validation trial of the Climate Schools: Alcohol and Cannabis course, an Internet-based prevention program, among a new cohort of Australian students. A cluster randomized controlled trial was conducted among 1103 students (Mage: 13.25 years) from 13 schools in Australia in 2012. Six schools received the Climate Schools course and 7 schools were randomized to a control group (health education as usual). All students completed a self-report survey at baseline and immediately post-intervention. Mixed-effects regressions were conducted for all outcome variables. Outcomes assessed included alcohol and cannabis use, knowledge and intentions to use these substances. Compared to the control group, immediately post-intervention the intervention group reported significantly greater alcohol (d = 0.67) and cannabis knowledge (d = 0.72), were less likely to have consumed any alcohol (even a sip or taste) in the past 6 months (odds ratio = 0.69) and were less likely to intend on using alcohol in the future (odds ratio = 0.62). However, there were no effects for binge drinking, cannabis use or intentions to use cannabis. These preliminary results provide some support for the Internet-based Climate Schools: Alcohol and Cannabis course as a feasible way of delivering alcohol and cannabis prevention. Intervention effects for alcohol and cannabis knowledge were consistent with results from the original trial; however, analyses of longer-term follow-up data are needed to provide a clearer indication of the efficacy of the intervention, particularly in relation to behavioral changes. © The Royal Australian and New Zealand College of Psychiatrists 2015.

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

Science.gov (United States)

Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

2015-07-01

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

Three-day Field Treatment with Ingenol Disoxate (LEO 43204) for Actinic Keratosis: A Phase II Trial.

Science.gov (United States)

Siegel, Daniel M; Tyring, Stephen; Nahm, Walter K; Østerdal, Marie Louise; Petersen, Astrid H; Berman, Brian

2017-12-01

OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of ingenol disoxate gel using a once-daily, three-day field treatment regimen in patients with actinic keratosis. DESIGN: This was a Phase II, multicenter, open-label trial (clinicaltrials.gov: NCT02305888). SETTING: The study was conducted in 20 trial sites in the United States. PARTICIPANTS: Participants included patients with 5 to 20 clinically typical actinic keratosis lesions on the full face/chest (250cm 2 ), scalp (25-250cm 2 ), or the trunk/extremities (250cm 2 ). MEASUREMENTS: We measured incidence of dose-limiting events based on local skin responses. Percentage reduction in actinic keratosis lesion count from baseline, complete clearance, and partial clearance (≥75%) of actinic keratosis lesions were assessed at Week 8. RESULTS: Nine of 63 (14.3%) patients in the face/chest group reported dose-limiting events; zero of 63 patients in the scalp group reported dose-limiting events; and 11 of 62 (17.7%) patients in the trunk/extremities group reported dose-limiting events. Mean composite local skin response scores peaked at Day 4, then rapidly declined, reaching or approaching baseline levels by Week 4. Less than five percent of patients reported severe adverse events; the most common treatment-related adverse events were application site pain and pruritus. The reduction in actinic keratosis lesion count was 78.9, 76.3, and 69.1 percent for the face/chest, scalp, and trunk/extremities groups, respectively. Complete clearance was achieved in 36.5, 39.7, and 22.6 percent of patients in the face/chest, scalp, and trunk/extremities groups, respectively. Partial clearance was achieved in 71.4, 65.1, and 50.0 percent of patients in the face/chest, scalp, and trunk/extremities groups, respectively. CONCLUSION: Ingenol disoxate demonstrated adverse events and local skin reaction profiles similar to results seen in trials evaluating shorter two-day regimens and was effective in patients

Limited accessibility to designs and results of Japanese large-scale clinical trials for cardiovascular diseases

Directory of Open Access Journals (Sweden)

Tsutani Kiichiro

2011-04-01

Full Text Available Abstract Background Clinical evidence is important for improving the treatment of patients by health care providers. In the study of cardiovascular diseases, large-scale clinical trials involving thousands of participants are required to evaluate the risks of cardiac events and/or death. The problems encountered in conducting the Japanese Acute Myocardial Infarction Prospective (JAMP study highlighted the difficulties involved in obtaining the financial and infrastructural resources necessary for conducting large-scale clinical trials. The objectives of the current study were: 1 to clarify the current funding and infrastructural environment surrounding large-scale clinical trials in cardiovascular and metabolic diseases in Japan, and 2 to find ways to improve the environment surrounding clinical trials in Japan more generally. Methods We examined clinical trials examining cardiovascular diseases that evaluated true endpoints and involved 300 or more participants using Pub-Med, Ichushi (by the Japan Medical Abstracts Society, a non-profit organization, websites of related medical societies, the University Hospital Medical Information Network (UMIN Clinical Trials Registry, and clinicaltrials.gov at three points in time: 30 November, 2004, 25 February, 2007 and 25 July, 2009. Results We found a total of 152 trials that met our criteria for 'large-scale clinical trials' examining cardiovascular diseases in Japan. Of these, 72.4% were randomized controlled trials (RCTs. Of 152 trials, 9.2% of the trials examined more than 10,000 participants, and 42.8% examined between 1,000 and 10,000 participants. The number of large-scale clinical trials markedly increased from 2001 to 2004, but suddenly decreased in 2007, then began to increase again. Ischemic heart disease (39.5% was the most common target disease. Most of the larger-scale trials were funded by private organizations such as pharmaceutical companies. The designs and results of 13 trials were not

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

Science.gov (United States)

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

2016-07-01

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

Recent Advances and Field Trial Results Integrating Cosmic Ray Muon Tomography with Other Data Sources for Mineral Exploration

Science.gov (United States)

Schouten, D.

2015-12-01

CRM GeoTomography Technologies, Inc. is leading the way in applying muon tomography to discovery and definition of dense ore bodies for mineral exploration and resource estimation. We have successfully imaged volcanogenic massive sulfide (VMS) deposits at mines in North America using our suite of field-proven muon tracking detectors, and are at various stages of development for other applications. Recently we developed in-house inversion software that integrates data from assays, surface and borehole gravity, and underground muon flux measurements. We have found that the differing geophysical data sources provide complementary information and that dramatic improvements in inversion results are attained using various inversion performance metrics related to the excess tonnage of the mineral deposits, as well as their spatial extents and locations. This presentation will outline field tests of muon tomography performed by CRM Geotomography in some real world examples, and will demonstrate the effectiveness of joint muon tomography, assay and gravity inversion techniques in field tests (where data are available) and in simulations.

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

International Nuclear Information System (INIS)

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

2006-08-01

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

Government regulation and public opposition create high additional costs for field trials with GM crops in Switzerland.

Science.gov (United States)

Bernauer, Thomas; Tribaldos, Theresa; Luginbühl, Carolin; Winzeler, Michael

2011-12-01

Field trials with GM crops are not only plant science experiments. They are also social experiments concerning the implications of government imposed regulatory constraints and public opposition for scientific activity. We assess these implications by estimating additional costs due to government regulation and public opposition in a recent set of field trials in Switzerland. We find that for every Euro spent on research, an additional 78 cents were spent on security, an additional 31 cents on biosafety, and an additional 17 cents on government regulatory supervision. Hence the total additional spending due to government regulation and public opposition was around 1.26 Euros for every Euro spent on the research per se. These estimates are conservative; they do not include additional costs that are hard to monetize (e.g. stakeholder information and dialogue activities, involvement of various government agencies). We conclude that further field experiments with GM crops in Switzerland are unlikely unless protected sites are set up to reduce these additional costs.

A low-cost repellent for malaria vectors in the Americas: results of two field trials in Guatemala and Peru.

Science.gov (United States)

Moore, Sarah J; Darling, Samuel T; Sihuincha, Moisés; Padilla, Norma; Devine, Gregor J

2007-08-01

The cost of mosquito repellents in Latin America has discouraged their wider use among the poor. To address this problem, a low-cost repellent was developed that reduces the level of expensive repellent actives by combining them with inexpensive fixatives that appear to slow repellent evaporation. The chosen actives were a mixture of para-menthane-diol (PMD) and lemongrass oil (LG). To test the efficacy of the repellent, field trials were staged in Guatemala and Peru. Repellent efficacy was determined by human-landing catches on volunteers who wore the experimental repellents, control, or 15% DEET. The studies were conducted using a balanced Latin Square design with volunteers, treatments, and locations rotated each night. In Guatemala, collections were performed for two hours, commencing three hours after repellent application. The repellent provided >98% protection for five hours after application, with a biting pressure of >100 landings per person/hour. The 15% DEET control provided lower protection at 92% (p 46 landings per person/hour. The 20% DEET control provided significantly lower protection at 64% (p < 0.0001). In both locations, the PMD/LG repellent provided excellent protection up to six hours after application against a wide range of disease vectors including Anopheles darlingi. The addition of fixatives to the repellent extended its longevity while enhancing efficacy and significantly reducing its cost to malaria-endemic communities.

Respiratory alkalosis and primary hypocapnia in Labrador Retrievers participating in field trials in high-ambient-temperature conditions.

Science.gov (United States)

Steiss, Janet E; Wright, James C

2008-10-01

To determine whether Labrador Retrievers participating in field trials develop respiratory alkalosis and hypocapnia primarily in conditions of high ambient temperatures. 16 Labrador Retrievers. At each of 5 field trials, 5 to 10 dogs were monitored during a test (retrieval of birds over a variable distance on land [1,076 to 2,200 m]; 36 assessments); ambient temperatures ranged from 2.2 degrees to 29.4 degrees C. For each dog, rectal temperature was measured and a venous blood sample was collected in a heparinized syringe within 5 minutes of test completion. Blood samples were analyzed on site for Hct; pH; sodium, potassium, ionized calcium, glucose, lactate, bicarbonate, and total CO2 concentrations; and values of PvO2 and PvCO2. Scatterplots of each variable versus ambient temperature were reviewed. Regression analysis was used to evaluate the effect of ambient temperature ( 21 degrees C) on each variable. Compared with findings at ambient temperatures 21 degrees C; rectal temperature did not differ. Two dogs developed signs of heat stress in 1 test at an ambient temperature of 29 degrees C; their rectal temperatures were higher and PvCO2 values were lower than findings in other dogs. When running distances frequently encountered at field trials, healthy Labrador Retrievers developed hyperthermia regardless of ambient temperature. Dogs developed respiratory alkalosis and hypocapnia at ambient temperatures > 21 degrees C.

Results from the Xylitol for Adult Caries Trial (X-ACT)

Science.gov (United States)

Bader, James D.; Vollmer, William M.; Shugars, Daniel A.; Gilbert, Gregg H.; Amaechi, Bennett T.; Brown, John P.; Laws, Reesa L.; Funkhouser, Kimberly A.; Makhija, Sonia K.; Ritter, André V.; Leo, Michael C.

2013-01-01

Background Although caries is prevalent in adults, few preventive therapies have been tested in adult populations. This randomized clinical trial evaluated the effectiveness of xylitol lozenges in preventing caries in elevated caries-risk adults. Methods X-ACT was a three-site placebo-controlled randomized trial. Participants (n=691) ages 21–80 consumed five 1.0 g xylitol or placebo lozenges daily for 33 months. Clinical examinations occurred at baseline, 12, 24 and 33 months. Results Xylitol lozenges reduced the caries increment 11%. This reduction, which represented less than one-third of a surface per year, was not statistically significant. There was no indication of a dose-response effect. Conclusions Daily use of xylitol lozenges did not result in a statistically or clinically significant reduction in 33-month caries increment among elevated caries-risk adults. Clinical Implications These results suggest that xylitol used as a supplement in adults does not significantly reduce their caries experience. PMID:23283923

Field Trial Results of a 14-channel GPR Integrated with a U.S. Program for 3-D Utility Mapping

Science.gov (United States)

Anspach, James H.

2013-04-01

Existing underground utilities continue to be a leading cause of highway construction delay claims in the United States. Although 80-90% of existing utilities can typically be discovered and mapped using a wide range of geophysical tools, there is a recognizable need to improve the process. Existing shortcomings to the utility mapping process include a lack of viable depth attributes, long field occupation times, low experience level of the field technicians, and separate survey / geophysics functions. The U.S. National Academies and its Transportation Research Board recently concluded a project on alleviating the existing utility mapping shortcomings through the development of enhanced GPR. An existing commercial 400MHz 14-channel towed array was enhanced with positioning and interpretation hardware and software over a 3-year US 2M program. Field trials for effectiveness were conducted in a city suburb commercialized environment where the relative permittivity values averaged 9.4. The effectiveness of enhanced GPR was compared to traditional utility mapping techniques (Single Channel GPR, FDEM, Acoustic, Sondes, Gradiometric Magnetometers) during the project. The project area utilities included natural gas, water, electric, telephone, cable, storm, sanitary, traffic control, and several unknown function lines. Depths for these utilities were mostly unknown. 81% of known (from records and field appurtenance visual observation) utilities were detected via traditional geophysical means. These traditional geophysical means also detected 14% additional and previously "unknown" utilities. The enhanced GPR detected approximately 40% of the known and unknown utilities, and found an additional 6% of utilities that were previously undetected. These additional utilities were subsequently determined to be small diameter abandoned water and gas systems in very poor and broken condition. Although it did well with metallic water and gas lines, communication and electric

Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2014.

Science.gov (United States)

Deane, Bryan R; Porkess, Sheuli

2018-07-01

The objective of this study was to assess the timely disclosure of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) during 2014. This is the final extension of three previously reported studies of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, and in 2012 and 2013. The original study found that over a three-year period over three-quarters of all trials were disclosed within 12 months and almost 90% were disclosed by the end of the study (31 January 2013). The extension studies (2012 and 2013 approvals) both showed an improvement in results disclosure within 12 months to 90%, and an overall disclosure rate of 92% and 93% respectively by the end of the studies. The methodology used was exactly as previously reported. Various publicly available information sources were searched for both clinical trial registration and disclosure of results. All completed company-sponsored trials related to each new medicine approved for marketing by the EMA in 2014, carried out in patients and recorded on a clinical trials registry and/or included in an EMA European Public Assessment Report (EPAR), were included. Information sources were searched between 1 May and 31 July 2016. The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 July 2016 (end of survey). Of the completed trials associated with 32 new medicines licensed to 22 different companies in 2014, results of 93% (505/542) had been disclosed within 12 months, and results of 96% (518/542) had been disclosed by 31 July 2016. The disclosure rate within 12 months of 93% suggests that industry is continuing to achieve disclosure in a timely manner. The overall disclosure rate at study end of 96% indicates that the improvement in transparency

Clinical Trial Results Summary for Laypersons: A User Testing Study.

Science.gov (United States)

Raynor, D K; Myers, L; Blackwell, K; Kress, B; Dubost, A; Joos, A

2018-01-01

To apply "user testing" to maximize readability and acceptability of a Clinical Trial Results Laypersons Summary-a new European requirement. "User testing" (using questionnaire and semistructured interview) assessed whether people could find and understand key points. Findings were used to improve content and design, prior to retesting. Participants had a range of levels of health literacy and there was a higher education group. Participants accessed the summary on screen. In round 1 we tested 12 points of information. In round 2 a revised summary addressing round 1 findings was tested, leading to a third final version. In round 1, 2 of 12 points of information did not reach the target and interviews raised further format and content issues (some distracting technical explanations and inability to find or understand the 2 main study purposes). These findings informed revisions for the version tested in round 2, with 2 different points not reaching the target (inclusion criteria relating to duration of seasonal allergies and how researchers found out about participants' symptoms). Identified problems in both rounds were addressed and reflected in the final version. Despite improvements, participants did not consistently understand that summaries were intended for the public, or to only interpret results of single trials in the context of additional trials. All readers, including those with higher education, found the clear and straightforward language acceptable. Applying "user testing" resulted in a largely health-literate summary suitable for people across a range of backgrounds.

Technical implementation in support of the IAEA's remote monitoring field trial at the Oak Ridge Y-12 Plant

International Nuclear Information System (INIS)

Corbell, B.H.; Moran, B.W.; Pickett, C.A.; Whitaker, J.M.; Resnik, W.; Landreth, D.

1996-01-01

A remote monitoring system (RMS) field trial will be conducted for the International Atomic Energy Agency (IAEA) on highly enriched uranium materials in a vault at the Oak Ridge Y-12 Plant. Remote monitoring technologies are being evaluated to verify their capability to enhance the effectiveness and timeliness of IAEA safeguards in storage facilities while reducing the costs of inspections and burdens on the operator. Phase one of the field trial, which involved proving the satellite transmission of sensor data and safeguards images from a video camera activated by seals and motion sensors installed in the vault, was completed in September 1995. Phase two involves formal testing of the RMS as a tool for use by the IAEA during their tasks of monitoring the storage of nuclear material. The field trial to be completed during early 1997 includes access and item monitoring of nuclear materials in two storage trays. The RMS includes a variety of Sandia, Oak Ridge, and Aquila sensor technologies that provide video monitoring, radiation attribute measurements, and container identification to the on-site data acquisition system (DAS) by way of radio-frequency and Echelon LONWorks networks. The accumulated safeguards information will be transmitted to the IAEA via satellite (COMSAT/RSI) and international telephone lines

The trials methodological research agenda: results from a priority setting exercise

Science.gov (United States)

2014-01-01

Background Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. Methods An on-line Delphi survey of 48 UK Clinical Research Collaboration registered Clinical Trials Units (CTUs) was undertaken. During round one, CTU Directors were asked to identify important topics that require methodological research. During round two, their opinion about the level of importance of each topic was recorded, and during round three, they were asked to review the group’s average opinion and revise their previous opinion if appropriate. Direct reminders were sent to maximise the number of responses at each round. Results are summarised using descriptive methods. Results Forty one (85%) CTU Directors responded to at least one round of the Delphi process: 25 (52%) responded in round one, 32 (67%) responded in round two, 24 (50%) responded in round three. There were only 12 (25%) who responded to all three rounds and 18 (38%) who responded to both rounds two and three. Consensus was achieved amongst CTU Directors that the top three priorities for trials methodological research were ‘Research into methods to boost recruitment in trials’ (considered the highest priority), ‘Methods to minimise attrition’ and ‘Choosing appropriate outcomes to measure’. Fifty other topics were included in the list of priorities and consensus was reached that two topics, ‘Radiotherapy study designs’ and ‘Low carbon trials’, were not priorities. Conclusions This priority setting exercise has identified the research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. The use of robust methodology to identify these priorities will help ensure that this work informs the trials methodological research agenda, with

Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

Science.gov (United States)

Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

2016-01-28

Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome

True fir-hemlock spacing trials: design and first results.

Science.gov (United States)

Robert O. Curtis; Gary W. Clendenen; Jan A. Henderson

2000-01-01

A series of 18 precommercial thinning trials was established in true fir-hemlock stands in the Olympic Mountains and along the west side of the Cascade Range in Washington and Oregon from 1987 through 1994. This paper documents establishment of these installations and presents some preliminary observations and results. Substantial differences in growth rates in height...

Statistical analysis of nitrous oxide emission factors from pastoral agriculture field trials conducted in New Zealand

International Nuclear Information System (INIS)

Kelliher, F.M.; Cox, N.; Weerden, T.J. van der; Klein, C.A.M. de; Luo, J.; Cameron, K.C.; Di, H.J.; Giltrap, D.; Rys, G.

2014-01-01

Between 11 May 2000 and 31 January 2013, 185 field trials were conducted across New Zealand to measure the direct nitrous oxide (N 2 O) emission factors (EF) from nitrogen (N) sources applied to pastoral soils. The log(EF) data were analysed statistically using a restricted maximum likelihood (REML) method. To estimate mean EF values for each N source, best linear unbiased predictors (BLUPs) were calculated. For lowland soils, mean EFs for dairy cattle urine and dung, sheep urine and dung and urea fertiliser were 1.16 ± 0.19% and 0.23 ± 0.05%, 0.55 ± 0.19% and 0.08 ± 0.02% and 0.48 ± 0.13%, respectively, each significantly different from one another (p 12°, mean EFs were significantly lower. Thus, urine and dung EFs should be disaggregated for sheep and cattle as well as accounting for terrain. -- Highlights: • Nitrous oxide emission factors (EFs) for pastoral soils measured in 185 field trials. • For lowland, the mean (±standard error) urea nitrogen fertiliser EF was 0.5 ± 0.1%. • For lowland, mean dairy cattle urine and dung EFs were 1.2 and 0.2%, respectively. • For lowland, mean sheep urine and dung EFs were 0.6 and 0.1%, respectively. • For pastoral soils in terrain with slopes >12°, mean EFs were significantly lower. -- From 185 field trials, mean nitrous oxide emission factors for pastoral soils were 0.1% for sheep dung up to 1.2% for dairy cattle urine, while that for urea fertiliser was 0.5%

Limited accessibility to designs and results of Japanese large-scale clinical trials for cardiovascular diseases.

Science.gov (United States)

Sawata, Hiroshi; Ueshima, Kenji; Tsutani, Kiichiro

2011-04-14

Clinical evidence is important for improving the treatment of patients by health care providers. In the study of cardiovascular diseases, large-scale clinical trials involving thousands of participants are required to evaluate the risks of cardiac events and/or death. The problems encountered in conducting the Japanese Acute Myocardial Infarction Prospective (JAMP) study highlighted the difficulties involved in obtaining the financial and infrastructural resources necessary for conducting large-scale clinical trials. The objectives of the current study were: 1) to clarify the current funding and infrastructural environment surrounding large-scale clinical trials in cardiovascular and metabolic diseases in Japan, and 2) to find ways to improve the environment surrounding clinical trials in Japan more generally. We examined clinical trials examining cardiovascular diseases that evaluated true endpoints and involved 300 or more participants using Pub-Med, Ichushi (by the Japan Medical Abstracts Society, a non-profit organization), websites of related medical societies, the University Hospital Medical Information Network (UMIN) Clinical Trials Registry, and clinicaltrials.gov at three points in time: 30 November, 2004, 25 February, 2007 and 25 July, 2009. We found a total of 152 trials that met our criteria for 'large-scale clinical trials' examining cardiovascular diseases in Japan. Of these, 72.4% were randomized controlled trials (RCTs). Of 152 trials, 9.2% of the trials examined more than 10,000 participants, and 42.8% examined between 1,000 and 10,000 participants. The number of large-scale clinical trials markedly increased from 2001 to 2004, but suddenly decreased in 2007, then began to increase again. Ischemic heart disease (39.5%) was the most common target disease. Most of the larger-scale trials were funded by private organizations such as pharmaceutical companies. The designs and results of 13 trials were not disclosed. To improve the quality of clinical

Exploratory field trial of motorcycle autonomous emergency braking (MAEB): Considerations on the acceptability of unexpected automatic decelerations.

Science.gov (United States)

Savino, Giovanni; Pierini, Marco; Thompson, Jason; Fitzharris, Michael; Lenné, Michael G

2016-11-16

Autonomous emergency braking (AEB) acts to slow down a vehicle when an unavoidable impending collision is detected. In addition to documented benefits when applied to passenger cars, AEB has also shown potential when applied to motorcycles (MAEB). However, the feasibility of MAEB as practically applied to motorcycles in the real world is not well understood. In this study we performed a field trial involving 16 riders on a test motorcycle subjected to automatic decelerations, thus simulating MAEB activation. The tests were conducted along a rectilinear path at nominal speed of 40 km/h and with mean deceleration of 0.15 g (15% of full braking) deployed at random times. Riders were also exposed to one final undeclared brake activation with the aim of providing genuinely unexpected automatic braking events. Participants were consistently able to manage automatic decelerations of the vehicle with minor to moderate effort. Results of undeclared activations were consistent with those of standard runs. This study demonstrated the feasibility of a moderate automatic deceleration in a scenario of motorcycle travelling in a straight path, supporting the notion that the application of AEB on motorcycles is practicable. Furthermore, the proposed field trial can be used as a reference for future regulation or consumer tests in order to address safety and acceptability of unexpected automatic decelerations on a motorcycle.

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

NARCIS (Netherlands)

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

2015-01-01

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

Consent revisited: the impact of return of results on participants' views and expectations about trial participation.

Science.gov (United States)

Tarrant, Carolyn; Jackson, Clare; Dixon-Woods, Mary; McNicol, Sarah; Kenyon, Sara; Armstrong, Natalie

2015-12-01

Increasingly, the sharing of study results with participants is advocated as an element of good research practice. Yet little is known about how receiving the results of trials may impact on participants' perceptions of their original decision to consent. We explored participants' views of their decision to consent to a clinical trial after they received results showing adverse outcomes in some arms of the trial. Semi-structured interviews were conducted with a purposive sample of 38 women in the UK who participated in a trial of antibiotics in pregnancy. All had received results from a follow-up study that reported increased risk of adverse outcomes for children of participants in some of the trial intervention arms. Data analysis was based on the constant comparative method. Participants' original decisions to consent to the trial had been based on hope of personal benefit and assumptions of safety. On receiving the results, most made sense of their experience in ways that enabled them to remain content with their decision to take part. But for some, the results provoked recognition that their original expectations might have been mistaken or that they had not understood the implications of their decision to participate. These participants experienced guilt, a sense of betrayal by the maternity staff and researchers involved in the trial, and damage to trust. Sharing of study results is not a wholly benign practice, and requires careful development of suitable approaches for further evaluation before widespread adoption. © 2015 The Authors Health Expectations Published by John Wiley & Sons Ltd.

A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial)

International Nuclear Information System (INIS)

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

2010-01-01

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

Molecular breast imaging: First results from Italian-National-Institute-of-Health clinical trials

Energy Technology Data Exchange (ETDEWEB)

Cusanno, F. [Istituto Superiore di Sanita' and INFN gruppo Sanita, Viale Regina Elena 299, 00161 Rome (Italy)]. E-mail: francesco.cusanno@iss.infn.it; Cisbani, E. [Istituto Superiore di Sanita' and INFN gruppo Sanita, Viale Regina Elena 299, 00161 Rome (Italy); Colilli, S. [Istituto Superiore di Sanita' and INFN gruppo Sanita, Viale Regina Elena 299, 00161 Rome (Italy); Fratoni, R. [Istituto Superiore di Sanita' and INFN gruppo Sanita, Viale Regina Elena 299, 00161 Rome (Italy); Garibaldi, F. [Istituto Superiore di Sanita' and INFN gruppo Sanita, Viale Regina Elena 299, 00161 Rome (Italy); Giuliani, F. [Istituto Superiore di Sanita' and INFN gruppo Sanita, Viale Regina Elena 299, 00161 Rome (Italy); Gricia, M. [Istituto Superiore di Sanita' and INFN gruppo Sanita, Viale Regina Elena 299, 00161 Rome (Italy); Lucentini, M. [Istituto Superiore di Sanita' and INFN gruppo Sanita, Viale Regina Elena 299, 00161 Rome (Italy); Magliozzi, M.L. [Istituto Superiore di Sanita' and INFN gruppo Sanita, Viale Regina Elena 299, 00161 Rome (Italy); Santanvenere, F. [Istituto Superiore di Sanita' and INFN gruppo Sanita, Viale Regina Elena 299, 00161 Rome (Italy); Torrioli, S. [Istituto Superiore di Sanita' and INFN gruppo Sanita, Viale Regina Elena 299, 00161 Rome (Italy); Cinti, M.N. [University La Sapienza, Rome (Italy); Pani, R. [University La Sapienza, Rome (Italy); Pellegrini, R. [University La Sapienza, Rome (Italy); Simonetti, G. [University Tor Vergata, Rome (Italy); Schillaci, O. [University Tor Vergata, Rome (Italy); Del Vecchio, S. [CNR Napoli, Naples (Italy); Salvatore, M. [CNR Napoli, Naples (Italy); Majewski, S. [Jefferson Lab, Newport News (United States); De Vincentis, G. [University La Sapienza, Rome (Italy); Scopinaro, F. [University La Sapienza, Rome (Italy)

2007-02-01

Dedicated high resolution detectors are needed for detection of small tumors by molecular imaging with radionuclides. Absorptive collimation are typically used for imaging single photon emitters, but it results in a strong reduction in efficiency. Systems based on electronic collimation offer higher efficiency but they are complex and expensive. In case of scintimammography, dual-head detectors increase sensitivity and cancel out the dependence of the lesion depth. In the system presented here, pixellated scintillator arrays (NaI:Tl) were coupled to arrays of PSPMT's, HPK H8500 Flat Panel. A dual-head detector having field of view of 100x100 mm{sup 2} and 150x200 mm{sup 2} were designed and built. The electronic system allows readout of all the anode pad signals. First clinical trials, performed in the framework of the Scintimammography project of Italian National Institute of Health and University of Tor Vergata in Rome, and University of Naples, are presented.

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

DEFF Research Database (Denmark)

Korn, Matthias; Bødker, Susanne

2012-01-01

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

Exploring and reducing stress in young restaurant workers: results of a randomized field trial.

Science.gov (United States)

Petree, Robyn D; Broome, Kirk M; Bennett, Joel B

2012-01-01

Young adult restaurant workers face the dual stressors of work adjustment and managing personal responsibilities. We assessed a new psychosocial/health promotion training designed to reduce these stressors in the context of restaurant work. DESIGN . A cluster-randomized trial of a training program, with surveys administered approximately 2 weeks before training and both 6 and 12 months after training. A national restaurant chain. A total of 947 restaurant workers in 28 restaurants. Personal stress, exposure to problem coworkers, and personal and job characteristics. Team Resilience (TR) is an interactive program for stress management, teamwork, and work-life balance. TR focuses on "five Cs" of resilience: compassion, commitment, centering, community, and confidence. ANALYSIS . Mixed-model (multilevel) analysis of covariances. Compared with workers in control stores, workers in TR-trained stores showed significant reductions over time in exposure to problem coworkers (F[2, 80.60]  =  4.48; p  =  .01) and in personal stress (F[2, 75.28]  =  6.12; p  =  .003). The TR program may help young workers who face the challenges of emerging adulthood and work-life balance.

The Study of Indoor and Field Trials on 2×8 MIMO Architecture in TD-LTE Network

Directory of Open Access Journals (Sweden)

Xiang Zhang

2013-01-01

the networks are based on frequency division duplexing (FDD. In this paper, measurement methods of four MIMO transmission modes (TMs in time division-LTE (TD-LTE are studied and analyzed. Link level simulation is carried out to evaluate the downlink throughput for different signal-to-noise ratios and parameter settings. Furthermore, indoor and field tests are also presented in the paper to investigate how real-world propagation affects the capacity and the error performance of MIMO transmission scheme. For the indoor test, radio channel emulators are applied to generate realistic wireless fading channel, while in the field trials, a live TD-LTE experiment cellular network is built, which contains several evolved nodeBs (eNBs and a precommercial user equipment (UE. It is shown from both simulation and tests results that MIMO deployment gives a substantial performance improvement compared with the third generation wireless networks.

Evaluation of pulsing magnetic field effects on paresthesia in multiple sclerosis patients, a randomized, double-blind, parallel-group clinical trial.

Science.gov (United States)

Afshari, Daryoush; Moradian, Nasrin; Khalili, Majid; Razazian, Nazanin; Bostani, Arash; Hoseini, Jamal; Moradian, Mohamad; Ghiasian, Masoud

2016-10-01

Evidence is mounting that magnet therapy could alleviate the symptoms of multiple sclerosis (MS). This study was performed to test the effects of the pulsing magnetic fields on the paresthesia in MS patients. This study has been conducted as a randomized, double-blind, parallel-group clinical trial during the April 2012 to October 2013. The subjects were selected among patients referred to MS clinic of Imam Reza Hospital; affiliated to Kermanshah University of Medical Sciences, Iran. Sixty three patients with MS were included in the study and randomly were divided into two groups, 35 patients were exposed to a magnetic pulsing field of 4mT intensity and 15-Hz frequency sinusoidal wave for 20min per session 2 times per week over a period of 2 months involving 16 sessions and 28 patients was exposed to a magnetically inactive field (placebo) for 20min per session 2 times per week over a period of 2 months involving 16 sessions. The severity of paresthesia was measured by the numerical rating scale (NRS) at 30, 60days. The study primary end point was NRS change between baseline and 60days. The secondary outcome was NRS change between baseline and 30days. Patients exposing to magnetic field showed significant paresthesia improvement compared with the group of patients exposing to placebo. According to our results pulsed magnetic therapy could alleviate paresthesia in MS patients .But trials with more patients and longer duration are mandatory to describe long-term effects. Copyright © 2016 Elsevier B.V. All rights reserved.

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

OpenAIRE

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

2016-01-01

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

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

Science.gov (United States)

Pohorecki, Wladyslaw; Obryk, Barbara

2017-09-29

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

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

Directory of Open Access Journals (Sweden)

Poeze Martijn

2011-05-01

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

Diclofenac Potassium in Acute Postoperative Pain and Dysmenorrhoea: Results from Comprehensive Clinical Trial Reports

Directory of Open Access Journals (Sweden)

R. Andrew Moore

2018-01-01

Full Text Available We compared the efficacy of diclofenac potassium in unpublished clinical study reports (CSRs and published reports to examine publication bias, industry bias, and comprehensiveness. Novartis provided CSRs of randomised double-blind trials of diclofenac potassium involving postoperative patients following third molar extraction (3 trials, n=519, gynaecological surgery (3 trials, n=679, and dysmenorrhoea (2 trials, n=711 conducted in 1988–1990. Searches identified published reports of 6 trials. Information from 599/1909 patients was not published; trials with 846/1909 patients were published in a defunct journal. Greater methodological information in CSRs contributed to lesser risk of bias than published trials. Numbers needed to treat (NNT from CSRs for all six postoperative trials for at least 50% of maximum pain relief over 6 h were 2.2 (95% confidence interval, 1.9–2.6 and 2.1 (1.8–2.4 for 50 and 100 mg diclofenac potassium, respectively. A Cochrane review of published trial data reported NNTs of 2.1 and 1.9, and one comprehensive analysis reported NNTs of 2.2 and 2.1, respectively. All analyses had similar results for patients remedicating within 8 h. No data from dysmenorrhoea CSRs appeared in a Cochrane review. CSRs provide useful information and increase confidence. Stable efficacy estimates with standard study designs reduce the need for updating reviews.

Beyond PubMed: Searching the "Grey Literature" for Clinical Trial Results.

Science.gov (United States)

Citrome, Leslie

2014-07-01

Clinical trial results have been traditionally communicated through the publication of scholarly reports and reviews in biomedical journals. However, this dissemination of information can be delayed or incomplete, making it difficult to appraise new treatments, or in the case of missing data, evaluate older interventions. Going beyond the routine search of PubMed, it is possible to discover additional information in the "grey literature." Examples of the grey literature include clinical trial registries, patent databases, company and industrywide repositories, regulatory agency digital archives, abstracts of paper and poster presentations on meeting/congress websites, industry investor reports and press releases, and institutional and personal websites.

Provenance trials of larch in Siberia

Energy Technology Data Exchange (ETDEWEB)

Milyutin, L.I. [V.N. Sukachev Inst. of Forest SB RAS, Krasnoyarsk (Russian Federation)

1995-12-31

Some results of provenance trials of larch in Siberia are given. These provenance trials were established in the last thirty years by efforts of V.N. Sukaczev Inst. of Forest. Provenances and species of larch were tested in some field trials distributed over Siberia between Lat. N 52 deg and 66 deg, Long. E 88 deg and 113 deg: near Krasnoyarsk, in Republic Khakasia (an altitudes of 800 and 1200 metres), in the Lower Yenisei near Turukhansk, in the west and south regions of Krasnoyarsk territory, in the Upper Lena, near Chita. 2 refs

Provenance trials of larch in Siberia

Energy Technology Data Exchange (ETDEWEB)

Milyutin, L I [V.N. Sukachev Inst. of Forest SB RAS, Krasnoyarsk (Russian Federation)

1996-12-31

Some results of provenance trials of larch in Siberia are given. These provenance trials were established in the last thirty years by efforts of V.N. Sukaczev Inst. of Forest. Provenances and species of larch were tested in some field trials distributed over Siberia between Lat. N 52 deg and 66 deg, Long. E 88 deg and 113 deg: near Krasnoyarsk, in Republic Khakasia (an altitudes of 800 and 1200 metres), in the Lower Yenisei near Turukhansk, in the west and south regions of Krasnoyarsk territory, in the Upper Lena, near Chita. 2 refs

Managing clinical trials

Directory of Open Access Journals (Sweden)

Kenyon Sara

2010-07-01

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

Cucumber cultivars for container gardening and the value of field trials for predicting Cucumber performance in containers

Science.gov (United States)

Cucumber (Cucumis sativus L.) is one of the most popular vegetable crops grown in U.S. home and urban gardens. The objectives of this study were to identify cultivars and planting densities for high yield of container-grown cucumbers. Additional objectives were to determine the value of field trials...

Patient reported outcome measures (PROMs) following forward planned field-in field IMRT: Results from the Cambridge Breast IMRT trial

International Nuclear Information System (INIS)

Mukesh, Mukesh B.; Qian, Wendi; Wilkinson, Jennifer S.; Dorling, Leila; Barnett, Gillian C.; Moody, Anne M.; Wilson, Charles; Twyman, Nicola; Burnet, Neil G.; Wishart, Gordon C.; Coles, Charlotte E.

2014-01-01

Background: The use of intensity-modulated radiotherapy (IMRT) in breast cancer reduces clinician-assessed breast tissue toxicity including fibrosis, telangectasia and sub-optimal cosmesis. Patient reported outcome measures (PROMs) are also important as they provide the patient’s perspective. This longitudinal study reports on (a) the effect of forward planned field-in-field IMRT (∼simple IMRT) on PROMs compared to standard RT at 5 years after RT, (b) factors affecting PROMs at 5 years after RT and (c) the trend of PROMs over 5 years of follow up. Methods: PROMs were assessed at baseline (pre-RT), 6, 24 and 60 months after completion of RT using global health (EORTC QLQ C30) and 4 breast symptom questions (BR23). Also, 4 breast RT-specific questions were included at 6, 24 and 60 months: change in skin appearance, firmness to touch, reduction in breast size and overall change in breast appearance since RT. The benefits of simple IMRT over standard RT at 5 years after RT were assessed using standard t-test for global health and logistic regression analysis for breast symptom questions and breast RT-specific questions. Clinical factors affecting PROMs at 5 years were investigated using a multivariate analysis. A repeated mixed model was applied to explore the trend over time for each of PROMs. Results: (89%) 727/815, 84%, 81% and 61% patients completed questionnaires at baseline, 6, 24 and 60 months respectively. Patients reported worse toxicity for all four BR23 breast symptoms at 6 months, which then improved over time (p < 0.0001). They also reported improvement in skin appearance and breast hardness over time (p < 0.0001), with no significant change for breast shrinkage (p = 0.47) and overall breast appearance (p = 0.13). At 5 years, PROMs assessments did not demonstrate a benefit for simple IMRT over standard radiotherapy. Large breast volume, young age, baseline surgical cosmesis and post-operative infection were the most important variables to affect PROMs

Joint remote data transmission field trial at Ahaus

International Nuclear Information System (INIS)

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

2001-05-01

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

Heat treatment trials for ITER toroidal field coils

International Nuclear Information System (INIS)

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

2012-01-01

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

Field trials of the phenomena of concern for psychiatric/mental health nursing: proposed methodology.

Science.gov (United States)

Wilson, H S

1989-10-01

An important step in the development of the American Nurses' Association (ANA) Task Force's Classification of Phenomena of Concern for Psychiatric/Mental Health Nursing is a plan for conducting field trials to determine interrater diagnostic reliability using the classification system. The ANA Task Force identified field testing as stage two in a three-stage process for completion of our work. In this article, we identify methodologic directions that will allow us to answer two important questions. First, what is the interrater reliability of the system of psychiatric nursing diagnoses when applied to clients by psychiatric/mental health nurse clinicians in their practice, and second, how do the clinicians who use this system view its usefulness for planning and evaluating nursing care?

Development of a compact underwater laser-induced breakdown spectroscopy (LIBS) system and preliminary results in sea trials.

Science.gov (United States)

Guo, Jinjia; Lu, Yuan; Cheng, Kai; Song, Jiaojian; Ye, Wangquan; Li, Nan; Zheng, Ronger

2017-10-10

The exploitation and research of deep-sea hydrothermal vent has been an issue of great interest in ocean research in recent years. Laser-induced breakdown spectroscopy (LIBS) has great potential for ocean application due to the capabilities of stand-off, multiphase, and multielement analysis. In this work, a newly developed compact 4000 m rated LIBS system (LIBSea) is introduced with preliminary results of sea trials. The underwater system consists of an Nd:YAG single-pulsed laser operating at 1064 nm, an optical fiber spectrometer, an optics module, and an electronic controller module. The whole system is housed in an L800  mm×ϕ258  mm pressure housing with an optical window on the end cap. It was deployed on the remote operated vehicle Faxian on the research vessel Kexue, and in June 2015 was successfully applied for hydrothermal field measurements at the Manus area. The obtained results are shown that the LIBS system is capable of detecting elements Li, Na, K, Ca, and Mg in the hydrothermal area. Profiles of LIBS signals of elements K and Ca have also been obtained during the sea trial. The results show that the K emission line is gradually broadened with depth from sea surface to sea floor (1800 m or so); the K intensity shows a hump shape with maximum value at about 1050 m. The Ca emission line is rapidly broadened below 400 m and slowly narrowed to the sea floor; the Ca intensity shows no obvious change below 400 m and increases continuously to sea floor. A very interesting finding is that the small fluctuations of intensity profile curve of Ca show a degree of correlation with seawater temperature change. The sea trial results prove the performance of LIBSea. After further optimization, it is hoped to apply the LIBS system to the in situ mineral deposits and hydrothermal vent fluid detection in deep sea.

Properties of plutonium-contaminated particles resulting from British Vixen B trials at Maralinga

International Nuclear Information System (INIS)

Burns, P.A.; Cooper, M.B.; Williams, G.A.; Johnston, P.N.

1990-12-01

Since 1984 a number of studies have been performed to investigate residual contamination at the former atomic weapons test site at Maralinga in South Australia, and to aid in the rehabilitation of the area. The largest site of plutonium contamination at Maralinga results from twelve Vixen B trials conduced at Taranaki in 1960, 1961 and 1963. Plutonium was dispersed along four major plumes from these trials. Measurements of the ratios of activities of 239 Pu and 240 Pu to 241 Am are presented for the plumes. These are identified with individual trials where possible. Some measurements have also been made of 235 U activities. An examination of meteorological and health physics survey data suggests that the most extensive part of the north-west plume results from a single trial, viz. Vixen B2 round 5 of 1961. It appears that the level of contamination in this plume was augmented by rainout of material, and the extent of the plume was enhanced by the considerable wind speed at the time. Results of proton-induced X-ray emission spectroscopy (PIXE), which provides elemental content and maps of the distribution of elements on the surface of some of the active particles, are presented, together with some other physical characteristics of the particles, in the expectation that these will aid in hazard assessment and with the development of techniques to rehabilitate the Taranaki site at Maralinga. 17 refs., 4 tabs., 1 fig

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

International Nuclear Information System (INIS)

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

2001-01-01

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

Wide Area Wind Field Monitoring Status & Results

Energy Technology Data Exchange (ETDEWEB)

Alan Marchant; Jed Simmons

2011-09-30

Volume-scanning elastic has been investigated as a means to derive 3D dynamic wind fields for characterization and monitoring of wind energy sites. An eye-safe volume-scanning lidar system was adapted for volume imaging of aerosol concentrations out to a range of 300m. Reformatting of the lidar data as dynamic volume images was successfully demonstrated. A practical method for deriving 3D wind fields from dynamic volume imagery was identified and demonstrated. However, the natural phenomenology was found to provide insufficient aerosol features for reliable wind sensing. The results of this study may be applicable to wind field measurement using injected aerosol tracers.

Multi-port versus single-port cholecystectomy: results of a multi-centre, randomised controlled trial (MUSIC trial).

Science.gov (United States)

Arezzo, Alberto; Passera, Roberto; Bullano, Alberto; Mintz, Yoav; Kedar, Asaf; Boni, Luigi; Cassinotti, Elisa; Rosati, Riccardo; Fumagalli Romario, Uberto; Sorrentino, Mario; Brizzolari, Marco; Di Lorenzo, Nicola; Gaspari, Achille Lucio; Andreone, Dario; De Stefani, Elena; Navarra, Giuseppe; Lazzara, Salvatore; Degiuli, Maurizio; Shishin, Kirill; Khatkov, Igor; Kazakov, Ivan; Schrittwieser, Rudolf; Carus, Thomas; Corradi, Alessio; Sitzman, Guenther; Lacy, Antonio; Uranues, Selman; Szold, Amir; Morino, Mario

2017-07-01

Single-port laparoscopic surgery as an alternative to conventional laparoscopic cholecystectomy for benign disease has not yet been accepted as a standard procedure. The aim of the multi-port versus single-port cholecystectomy trial was to compare morbidity rates after single-access (SPC) and standard laparoscopy (MPC). This non-inferiority phase 3 trial was conducted at 20 hospital surgical departments in six countries. At each centre, patients were randomly assigned to undergo either SPC or MPC. The primary outcome was overall morbidity within 60 days after surgery. Analysis was by intention to treat. The study was registered with ClinicalTrials.gov (NCT01104727). The study was conducted between April 2011 and May 2015. A total of 600 patients were randomly assigned to receive either SPC (n = 297) or MPC (n = 303) and were eligible for data analysis. Postsurgical complications within 60 days were recorded in 13 patients (4.7 %) in the SPC group and in 16 (6.1 %) in the MPC group (P = 0.468); however, single-access procedures took longer [70 min (range 25-265) vs. 55 min (range 22-185); P risk of incisional hernia following SPC do not appear to be justified. Patient satisfaction with aesthetic results was greater after SPC than after MPC.

Analysis and Thoughts about the Negative Results of International Clinical Trials on Acupuncture

Science.gov (United States)

Han, Yan-jing; Wang, Xiao-hong; Li, Chen; Liu, Wan-ning

2015-01-01

An increasing number of randomized controlled trials (RCTs) of acupuncture have proved the clinical benefits of acupuncture; however, there are some results that have shown negative results or placebo effects. The paper carried out an in-depth analysis on 33 RCTs in the 2011 SCI database, the quality of the reports was judged according to Jadad scores, and the “Necessary Information Included in Reporting Interventions in Clinical Trials of Acupuncture (STRICTA 2010)” was taken as the standard to analyze the rationality of the therapeutic principle. The difference between the methodology (Jadad) scores of the two types of research reports did not constitute statistical significance (P > 0.05). The studies with negative results or placebo effects showed the following deficiencies with respect to intervention details: (1) incompletely rational acupoint selection; (2) inconsistent ability of acupuncturists; (3) negligible needling response to needling; (4) acupuncture treatment frequency too low in most studies; and (5) irrational setting of placebo control. Thus, the primary basis for the negative results or placebo effects of international clinical trials on acupuncture is not in the quality of the methodology, but in noncompliance with the essential requirements proposed by acupuncture theory in terms of clinical manipulation details. PMID:26161126

Transversity results and computations in symplectic field theory

International Nuclear Information System (INIS)

Fabert, Oliver

2008-01-01

Although the definition of symplectic field theory suggests that one has to count holomorphic curves in cylindrical manifolds R x V equipped with a cylindrical almost complex structure J, it is already well-known from Gromov-Witten theory that, due to the presence of multiply-covered curves, we in general cannot achieve transversality for all moduli spaces even for generic choices of J. In this thesis we treat the transversality problem of symplectic field theory in two important cases. In the first part of this thesis we are concerned with the rational symplectic field theory of Hamiltonian mapping tori, which is also called the Floer case. For this observe that in the general geometric setup for symplectic field theory, the contact manifolds can be replaced by mapping tori M φ of symplectic manifolds (M,ω M ) with symplectomorphisms φ. While the cylindrical contact homology of M φ is given by the Floer homologies of powers of φ, the other algebraic invariants of symplectic field theory for M φ provide natural generalizations of symplectic Floer homology. For symplectically aspherical M and Hamiltonian φ we study the moduli spaces of rational curves and prove a transversality result, which does not need the polyfold theory by Hofer, Wysocki and Zehnder and allows us to compute the full contact homology of M φ ≅ S 1 x M. The second part of this thesis is devoted to the branched covers of trivial cylinders over closed Reeb orbits, which are the trivial examples of punctured holomorphic curves studied in rational symplectic field theory. Since all moduli spaces of trivial curves with virtual dimension one cannot be regular, we use obstruction bundles in order to find compact perturbations making the Cauchy-Riemann operator transversal to the zero section and show that the algebraic count of elements in the resulting regular moduli spaces is zero. Once the analytical foundations of symplectic field theory are established, our result implies that the

Early results from Magsat. [studies of near-earth magnetic fields

Science.gov (United States)

Langel, R. A.; Estes, R. H.; Mayhew, M. A.

1981-01-01

Papers presented at the May 27, 1981 meeting of the American Geophysical Union concerning early results from the Magsat satellite program, which was designed to study the near-earth magnetic fields originating in the core and lithosphere, are discussed. The satellite was launched on October 30, 1979 into a sun-synchronous (twilight) orbit, and re-entered the atmosphere on June 11, 1980. Instruments carried included a cesium vapor magnetometer to measure field magnitudes, a fluxgate magnetometer to measure field components and an optical system to measure fluxgate magnetometer orientation. Early results concerned spherical harmonic models, fields due to ionospheric and magnetospheric currents, the identification and interpretation of fields from lithospheric sources. The preliminary results confirm the possibility of separating the measured field into core, crustal and external components, and represent significant developments in analytical techniques in main-field modelling and the physics of the field sources.

Results of two randomised clinical trials of neutron therapy in rectal adenocarcinoma

International Nuclear Information System (INIS)

Duncan, W.; Arnott, S.J.; Jack, W.J.L.; Orr, J.A.; Kerr, G.R.; Williams, J.R.

1987-01-01

Two clinical trials of neutron therapy were instituted to compare fast neutron therapy with megavoltage therapy in inoperable adenocarcinoma of the rectum and in postoperative recurrent adenocarcinoma of the rectum and to evaluate local tumour control, radiation morbidity and survival rates. In both rectal trials, complete local regression and persistent local control of tumour were similar in each treatment group. Survival was poor and so there is little long-term experience of tumour control and morbidity. The possibility that the relatively poor penetration of the neutron beam had an adverse effect on the results of neutron therapy should be considered. (Auth.)

A randomised controlled trial to assess the effectiveness of offering study results as an incentive to increase response rates to postal questionnaires [ISRCTN26118436

Directory of Open Access Journals (Sweden)

Torgerson David J

2005-10-01

Full Text Available Abstract Background Postal questionnaires are widely used to collect outcome data on participants. However, a poor response to questionnaires will reduce the statistical power of the study and may introduce bias. A meta analysis of ten trials offering study results, largely in the fields of education and marketing, was shown to be ineffective, with the odds ratio for response with offering research findings is 0.92 (95% CI 0.75 to 1.11. However uncertainty still exists as it is uncertain whether results from such trials can be extrapolated to that of a health care setting. The aim of this study was to assess whether offering participants study results increases the response rates to postal questionnaires. Methods 1038 women aged over 70 years were remotely randomised by computer in a 3:1 ratio. 250 participants did not receive the offer of knowing the results of the trial and 788 participants were offered the results of the trial in a postal questionnaire. The main outcome measure was response rate. Chi square test was used to evaluate the overall differences in response rate between the two groups. An adjusted analysis, adjusting for whether the participant was taking calcium and age was also undertaken. Results The response rates were not significantly different Odds Ratio 0.88 (95% confidence intervals 0.48 to 1.63 p = 0.69. Conclusion Offering study results to women living in the community aged over 70 does not increase response rates to postal questionnaires. Although researchers have an ethical obligation to offer participants study results, since 10% of women did not wish to receive the results, investigators should give participants the option to opt out of receiving the study's results.

Why are clinicians not embracing the results from pivotal clinical trials in severe sepsis? A bayesian analysis.

Directory of Open Access Journals (Sweden)

Andre C Kalil

Full Text Available BACKGROUND: Five pivotal clinical trials (Intensive Insulin Therapy; Recombinant Human Activated Protein C [rhAPC]; Low-Tidal Volume; Low-Dose Steroid; Early Goal-Directed Therapy [EGDT] demonstrated mortality reduction in patients with severe sepsis and expert guidelines have recommended them to clinical practice. Yet, the adoption of these therapies remains low among clinicians. OBJECTIVES: We selected these five trials and asked: Question 1--What is the current probability that the new therapy is not better than the standard of care in my patient with severe sepsis? Question 2--What is the current probability of reducing the relative risk of death (RRR of my patient with severe sepsis by meaningful clinical thresholds (RRR >15%; >20%; >25%? METHODS: Bayesian methodologies were applied to this study. Odds ratio (OR was considered for Question 1, and RRR was used for Question 2. We constructed prior distributions (enthusiastic; mild, moderate, and severe skeptic based on various effective sample sizes of other relevant clinical trials (unfavorable evidence. Posterior distributions were calculated by combining the prior distributions and the data from pivotal trials (favorable evidence. MAIN FINDINGS: Answer 1--The analysis based on mild skeptic prior shows beneficial results with the Intensive Insulin, rhAPC, and Low-Tidal Volume trials, but not with the Low-Dose Steroid and EGDT trials. All trials' results become unacceptable by the analyses using moderate or severe skeptic priors. Answer 2--If we aim for a RRR>15%, the mild skeptic analysis shows that the current probability of reducing death by this clinical threshold is 88% for the Intensive Insulin, 62-65% for the Low-Tidal Volume, rhAPC, EGDT trials, and 17% for the Low-Dose Steroid trial. The moderate and severe skeptic analyses show no clinically meaningful reduction in the risk of death for all trials. If we aim for a RRR >20% or >25%, all probabilities of benefits become lower

Aleph Field Solver Challenge Problem Results Summary

Energy Technology Data Exchange (ETDEWEB)

Hooper, Russell [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Moore, Stan Gerald [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

2015-01-01

Aleph models continuum electrostatic and steady and transient thermal fields using a finite-element method. Much work has gone into expanding the core solver capability to support enriched modeling consisting of multiple interacting fields, special boundary conditions and two-way interfacial coupling with particles modeled using Aleph's complementary particle-in-cell capability. This report provides quantitative evidence for correct implementation of Aleph's field solver via order- of-convergence assessments on a collection of problems of increasing complexity. It is intended to provide Aleph with a pedigree and to establish a basis for confidence in results for more challenging problems important to Sandia's mission that Aleph was specifically designed to address.

Field trial of GABA-fortified rice plants and oral administration of milled rice in spontaneously hypertensive rats.

Science.gov (United States)

Kowaka, Emi; Shimajiri, Yasuka; Kawakami, Kouhei; Tongu, Miki; Akama, Kazuhito

2015-06-01

Hypertension is one of the most critical risk factors accompanying cardiovascular diseases. γ-Aminobutyric acid (GABA) is a non-protein amino acid that functions as a major neurotransmitter in mammals and also as a blood-pressure lowering agent. We previously produced GABA-fortified rice lines of a popular Japonica rice cultivar 'Koshihikari' by genetic manipulation of GABA shunt-related genes. In the study reported here, we grew these same novel rice lines in a field trial and administered the milled rice orally to rats. The yield parameters of the transgenic rice plants were almost unchanged compared to those of untransformed cv. 'Koshihikari' plants, while the rice grains of the transgenic plants contained a high GABA content (3.5 g GABA/kg brown rice; 0.75-0.85 GABA g/kg milled rice) in a greenhouse trial. Oral administration of a diet containing 2.5% GABA-fortified rice, with a daily intake for 8 weeks, had an approximately 20 mmHg anti-hypertensive effect in spontaneous hypertensive rats but not in normotensive Wistar-Kyoto rats. These results suggest that GABA-fortified rice may be applicable as a staple food to control or prevent hypertension.

Prospective, randomized, open-label, blinded-endpoint (PROBE) designed trials yield the same results as double-blind, placebo-controlled trials with respect to ABPM measurements.

Science.gov (United States)

Smith, David H; Neutel, Joel M; Lacourcière, Yves; Kempthorne-Rawson, Joan

2003-07-01

This meta-analysis aimed to determine whether ambulatory blood pressure monitoring (ABPM) results from double-blind, placebo-controlled (DBPC) and prospective, randomized, open-label, blinded-endpoint (PROBE) hypertension trials are statistically comparable. Two DBPC and three PROBE parallel-group studies were selected from an angiotensin II receptor blocker clinical programme. These were fixed-dose studies involving similar mild to moderate hypertensive patient populations. All used SpaceLabs 90207 ABPM devices, and each comprised a 4-week placebo period and a 4-8-week treatment period. Data from patients receiving telmisartan 80 mg were used to compare the results of DBPC (126 patients) and PROBE (734 patients) trials. The analysis had approximately 87% power to show equivalence between the two design types in terms of ruling out differences of >or= 3 mmHg in SBP and >or= 2 mmHg in DBP. Office blood pressure was also compared. The change from baseline in mean 24-h ambulatory SBP was -12.2 mmHg in DBPC trials and -12.3 mmHg in PROBE trials, a rounded difference of 0.2 mmHg [95% confidence interval (CI): -1.8, 2.1]. The change from baseline in mean 24-h ambulatory DBP was -7.7 mmHg in DBPC trials versus -7.9 mmHg in PROBE trials, a difference of 0.2 mmHg (95% CI: -1.1, 1.5). Ambulatory pulse pressure results were identical. Thus, changes in mean 24-h ambulatory blood pressure from the DBPC and PROBE trials in this meta-analysis are statistically equivalent in terms of ruling out a difference of >or= 3 mmHg in SBP and >or= 2 mmHg in DBP. This supports the validity of the PROBE design in assessing antihypertensive efficacy based on blinded ABPM measurements.

Intraoperative photodynamic therapy of bladder cancer with alasens (results of multicenter trial

Directory of Open Access Journals (Sweden)

E. V. Filonenko

2014-01-01

Full Text Available The results of multicenter prospective trial for efficacy of combined modality treatment: transurethral resection (TUR + photodynamic therapy (PDT with alasens for bladder cancer are represented in the article. Trials were organized by Research Institute of Organic Intermediates and Dyes and conducted according to clinical protocol approved by Ministry of Health of Russia, at the sites of leading Russian cancer clinical centers. The trial included 45 subjects with verified diagnosis of non-muscle-invasive bladder cancer. Patients underwent TUR of bladder with simultaneous PDT as anti-relapse treatment. Alasens was administered to patients as intravesicular instillation of 3% solution in volume of 50 ml with 1.5–2h exposure (prior to TUR. TUR was performed after instillation. PDT session was conducted immediately after the completion of TUR on a single occasion by means of combined local irradiation on tumor bed with diffuse irradiation on whole urinary bladder mucosa (light dose of local irradiation – 100 J/cm2, diffuse irradiation – 20 J/cm2. Good tolerance of the treatment was noticed, there were no complications. Among 45 patients included in the trial, 35 (78% completed 12 month protocol follow-up without relapse. The recurrence of bladder tumor was registered in 10 (22% cases 6–12 months after TUR+PDT including 3 patients with recurrence 6 months after treatment, 3–9 months and 4–12 months. These patients underwent repeated TUR, whereafter their follow-up in the settings of the clinical trial was disposed. Thus, PDT with alasens after TUR allowed to decrease the recurrence rate of non-muscle-invasive bladder cancer for 1st year after treatment to 22% versus 40–80% for TUR as monotherapy according to literature data. The obtained results were comparable by efficiency with TUR combined with methods of adjuvant treatment for bladder tumors (the recurrence rates for 1-year follow-up after TUR+chemotherapy – 36–44%, after TUR

Open-field exposure facilitates consummatory extinction.

Science.gov (United States)

Justel, Nadia; Psyrdellis, Mariana; Pautassi, Ricardo M

2016-12-07

During extinction, the organism learns that a conditioned stimulus or a conditioned response is no longer associated with an unconditioned stimulus, and as a consequence, a decrement in the response is presented. The exposure to novel situations (e.g. exploration of a novel open field) has been used widely to modulate (i.e. either enhance or deteriorate) learning and memory. The aim of the present study was to test whether open-field exposure could modulate consummatory extinction. The results indicated that open-field exposure accelerated the extinction response (i.e. experimental animals provided novelty exposure had lower consummatory behavior than control animals) when applied before - but not after - the first extinction trial, or when applied before the second extinction trial. The results suggest that environmental treatments such as novelty exposure provide a valuable, nonpharmacological alternative to potentially modulate extinction processes.

Household Air Pollution Intervention Implications: Findings from Qualitative Studies and a Field Trial of Clean Cookstoves in Two Rural Villages in India.

Science.gov (United States)

Alam, Ashraful; Tawale, Nanda; Patel, Archana; Dibley, Michael J; Jadhao, Sunil; Raynes-Greenow, Camille

2016-09-09

Exposure to household air pollution is estimated to be the 3rd largest contributor to the global burden of disease and the largest contributor in South Asia. Unacceptability of improved cook stoves by the intended user has been identified as a crucial factor hindering uptake and sustained use. We conducted a qualitative study to understand the socio-cultural factors that influence acceptance of improved cookstoves and conducted a systematic field trial in two rural villages in Maharashtra, India. The qualitative study used semi-structured in-depth interviews and focus group discussions. We included women primarily responsible for household cooking, their husbands, senior women in their households, and community health workers. We also conducted kitchen observations. The results indicated low awareness and knowledge of the health risks associated with traditional cookstove use although high prevalence of household air pollution (HAP) exposure symptoms among all groups. Women were resigned to using traditional cookstoves although they did not like them. The field trial findings were dominated by responses concerned with convenience and health advantages. We identify important issues to be considered when introducing an improved cookstove programme that will increase acceptability and potentially sustained used of improved cookstoves.

Transversity results and computations in symplectic field theory

Energy Technology Data Exchange (ETDEWEB)

Fabert, Oliver

2008-02-21

Although the definition of symplectic field theory suggests that one has to count holomorphic curves in cylindrical manifolds R x V equipped with a cylindrical almost complex structure J, it is already well-known from Gromov-Witten theory that, due to the presence of multiply-covered curves, we in general cannot achieve transversality for all moduli spaces even for generic choices of J. In this thesis we treat the transversality problem of symplectic field theory in two important cases. In the first part of this thesis we are concerned with the rational symplectic field theory of Hamiltonian mapping tori, which is also called the Floer case. For this observe that in the general geometric setup for symplectic field theory, the contact manifolds can be replaced by mapping tori M{sub {phi}} of symplectic manifolds (M,{omega}{sub M}) with symplectomorphisms {phi}. While the cylindrical contact homology of M{sub {phi}} is given by the Floer homologies of powers of {phi}, the other algebraic invariants of symplectic field theory for M{sub {phi}} provide natural generalizations of symplectic Floer homology. For symplectically aspherical M and Hamiltonian {phi} we study the moduli spaces of rational curves and prove a transversality result, which does not need the polyfold theory by Hofer, Wysocki and Zehnder and allows us to compute the full contact homology of M{sub {phi}} {approx_equal} S{sup 1} x M. The second part of this thesis is devoted to the branched covers of trivial cylinders over closed Reeb orbits, which are the trivial examples of punctured holomorphic curves studied in rational symplectic field theory. Since all moduli spaces of trivial curves with virtual dimension one cannot be regular, we use obstruction bundles in order to find compact perturbations making the Cauchy-Riemann operator transversal to the zero section and show that the algebraic count of elements in the resulting regular moduli spaces is zero. Once the analytical foundations of symplectic

Optimising and evaluating the characteristics of a multiple antigen ELISA for detection of Mycobacterium bovis infection in a badger vaccine field trial.

Directory of Open Access Journals (Sweden)

Inma Aznar

Full Text Available A long-term research programme has been underway in Ireland to evaluate the usefulness of badger vaccination as part of the national bTB (bovine tuberculosis control strategy. This culminated in a field trial which commenced in county Kilkenny in 2009 to determine the effects of badger vaccination on Mycobacterium bovis transmission in badgers under field conditions. In the present study, we sought to optimise the characteristics of a multiplex chemiluminescent assay for detection of M. bovis infection in live badgers. Our goal was to maximise specificity, and therefore statistical power, during evaluation of the badger vaccine trial data. In addition, we also aimed to explore the effects of vaccination on test characteristics. For the test optimisation, we ran a stepwise logistic regression with analytical weights on the converted Relative Light Units (RLU obtained from testing blood samples from 215 badgers captured as part of culling operations by the national Department of Agriculture, Food and the Marine (DAFM. The optimised test was applied to two other datasets obtained from two captive badger studies (Study 1 and Study 2, and the sensitivity and specificity of the test was attained separately for vaccinated and non-vaccinated badgers. During optimisation, test sensitivity was maximised (30.77%, while retaining specificity at 99.99%. When the optimised test was then applied to the captive badger studies data, we observed that test characteristics did not vary greatly between vaccinated and non-vaccinated badgers. However, a different time lag between infection and a positive test result was observed in vaccinated and non-vaccinated badgers. We propose that the optimized multiplex immunoassay be used to analyse the vaccine trial data. In relation to the difference in the time lag observed for vaccinated and non-vaccinated badgers, we also present a strategy to enable the test to be used during trial evaluation.

Pyramiding of transgenic Pm3 alleles in wheat results in improved powdery mildew resistance in the field.

Science.gov (United States)

Koller, Teresa; Brunner, Susanne; Herren, Gerhard; Hurni, Severine; Keller, Beat

2018-04-01

The combined effects of enhanced total transgene expression level and allele-specificity combination in transgenic allele-pyramided Pm3 wheat lines result in improved powdery mildew field resistance without negative pleiotropic effects. Allelic Pm3 resistance genes of wheat confer race-specific resistance to powdery mildew (Blumeria graminis f. sp. tritici, Bgt) and encode nucleotide-binding domain, leucine-rich repeat (NLR) receptors. Transgenic wheat lines overexpressing alleles Pm3a, b, c, d, f, and g have previously been generated by transformation of cultivar Bobwhite and tested in field trials, revealing varying degrees of powdery mildew resistance conferred by the transgenes. Here, we tested four transgenic lines each carrying two pyramided Pm3 alleles, which were generated by crossbreeding of lines transformed with single Pm3 alleles. All four allele-pyramided lines showed strongly improved powdery mildew resistance in the field compared to their parental lines. The improved resistance results from the two effects of enhanced total transgene expression levels and allele-specificity combinations. In contrast to leaf segment tests on greenhouse-grown seedlings, no allelic suppression was observed in the field. Plant development and yield scores of the pyramided lines were similar to the mean scores of the corresponding parental lines, and thus, the allele pyramiding did not cause any negative effects. On the contrary, in pyramided line, Pm3b × Pm3f normal plant development was restored compared to the delayed development and reduced seed set of parental line Pm3f. Allele-specific RT qPCR revealed additive transgene expression levels of the two Pm3 alleles in the pyramided lines. A positive correlation between total transgene expression level and powdery mildew field resistance was observed. In summary, allele pyramiding of Pm3 transgenes proved to be successful in enhancing powdery mildew field resistance.

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

Science.gov (United States)

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

2017-07-18

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

Prosthodontic maintenance of overdentures on zirconia implants: 1-year results of a randomized controlled trial.

Science.gov (United States)

Osman, Reham B; Ma, Sunyoung

2014-01-01

The purpose of this study was to determine the prosthodontic outcomes of one-piece zirconia implants and their attachment systems in edentulous participants with maxillary and mandibular overdentures after 1 year of a randomized controlled trial. Random allocation of 24 edentulous participants (age range: 45 to 86 years) into titanium (control) or zirconia (test) groups using onepiece implants and a planned unsplinted prosthodontic design was performed. Four maxillary implants (one midpalatal; three anterior crestal) and three mandibular implants (one midsymphyseal; two bilateral distal) were conventionally loaded with the overdentures. Similar attachment systems were used throughout: ball abutment-type patrices (diameter: 2.25 to 3.1 mm as part of the one-piece implants) and custommade plastic matrices (with or without metal housings depending on the patrix size). Prosthodontic outcomes were documented during the first year of the clinical trial. Following three deaths and two dropouts, there were 19 participants who were available at the 1-year recall. Of these participants, 3 had early maxillary implant failure and had to be converted to conventional maxillary complete dentures opposing mandibular implant overdentures. There were 79 maintenance events, 34 in the titanium (control) group and 45 in the zirconia (test) group. Patrix loss occurred as a result of three zirconia implant fractures (one mandibular and two crestal maxillary implants). Maintenance events were principally the replacement of matrices and overdenture fracture. Although relines and replacement overdentures also occurred, overall there were no significant differences in prosthodontic maintenance between the control and test groups. A six-field prosthodontic-success analysis table showed no statistically significant difference between the two groups; however, 50% of participants in each group were allocated to the retreatment (repair) field, which produced a low prosthodontic success rate

Electrokinetic remediation of plutonium-contaminated nuclear site wastes: Results from a pilot-scale on-site trial

International Nuclear Information System (INIS)

Agnew, Kieran; Cundy, Andrew B.; Hopkinson, Laurence; Croudace, Ian W.; Warwick, Phillip E.; Purdie, Philip

2011-01-01

This paper examines the field-scale application of a novel low-energy electrokinetic technique for the remediation of plutonium-contaminated nuclear site soils, using soil wastes from the Atomic Weapons Establishment (AWE) Aldermaston site, Berkshire, UK as a test medium. Soils and sediments with varying composition, contaminated with Pu through historical site operations, were electrokinetically treated at laboratory-scale with and without various soil pre-conditioning agents. Results from these bench-scale trials were used to inform a larger on-site remediation trial, using an adapted containment pack with battery power supply. 2.4 m 3 (ca. 4 tonnes) of Pu-contaminated soil was treated for 60 days at a power consumption of 33 kW h/m 3 , and then destructively sampled. Radiochemical data indicate mobilisation of Pu in the treated soil, and migration (probably as a negatively charged Pu-citrate complex) towards the anodic compartment of the treatment cell. Soil in the cathodic zone of the treatment unit was remediated to a level below free-release disposal thresholds (1.7 Bq/g, or <0.4 Bq/g above background activities). The data show the potential of this method as a low-cost, on-site tool for remediation of radioactively contaminated soils and wastes which can be operated remotely on working sites, with minimal disruption to site infrastructure or operations.

First field trial of a transmissible recombinant vaccine against myxomatosis and rabbit hemorrhagic disease.

Science.gov (United States)

Torres, J M; Sánchez, C; Ramírez, M A; Morales, M; Bárcena, J; Ferrer, J; Espuña, E; Pagès-Manté, A; Sánchez-Vizcaíno, J M

2001-08-14

As a novel approach for immunisation of wild rabbits, we have recently developed a transmissible vaccine against myxomatosis and rabbit hemorrhagic disease (RHD) based on a recombinant myxoma virus (MV) expressing the RHDV capsid protein [J. Virol. 74 (2000) 1114]. The efficacy and safety of the vaccine have been extensively evaluated under laboratory conditions. In this study, we report the first limited field trial of the candidate vaccine that was undertaken in an island of 34 Has containing a population of around 300 rabbits. Following administration by the subcutaneous route to 76 rabbits, the vaccine induced specific antibody responses against both myxomatosis and RHDV in all the inoculated rabbits. Furthermore, the recombinant virus exhibited a limited horizontal transmission capacity, promoting seroconversion of around 50% of the uninoculated rabbit population. No evidence of undesirable effects due to the recombinant virus field release was detected.

Performance of breast cancer screening using digital breast tomosynthesis: results from the prospective population-based Oslo Tomosynthesis Screening Trial.

Science.gov (United States)

Skaane, Per; Sebuødegård, Sofie; Bandos, Andriy I; Gur, David; Østerås, Bjørn Helge; Gullien, Randi; Hofvind, Solveig

2018-02-10

Digital breast tomosynthesis (DBT) has the potential to overcome limitations of conventional mammography. This study investigated the effects of addition of DBT on interval and detected cancers in population-based screening. Oslo Tomosynthesis Screening Trial (OTST) was a prospective, independent double-reading trial inviting women 50-69 years biennially, comparing full-field digital mammography (FFDM) plus DBT with FFDM alone. Performance indicators and characteristics of screen-detected and interval cancers were compared with two previous FFDM rounds. 24,301 consenting women underwent FFDM + DBT screening over a 2-year period. Results were compared with 59,877 FFDM examinations during prior rounds. Addition of DBT resulted in a non-significant increase in sensitivity (76.2%, 378/496, vs. 80.8%, 227/281, p = 0.151) and a significant increase in specificity (96.4%, 57229/59381 vs. 97.5%, 23427/24020, p < .001). Number of recalls per screen-detected cancer decreased from 6.7 (2530/378) to 3.6 (820/227) with DBT (p < .001). Cancer detection per 1000 women screened increased (6.3, 378/59877, vs. 9.3, 227/24301, p < .001). Interval cancer rate per 1000 screens for FFDM + DBT remained similar to previous FFDM rounds (2.1, 51/24301 vs. 2.0, 118/59877, p = 0.734). Interval cancers post-DBT were comparable to prior rounds but significantly different in size, grade, and node status from cancers detected only using DBT. 39.6% (19/48) of interval cancers had positive nodes compared with only 3.9% (2/51) of additional DBT-only-detected cancers. DBT-supplemented screening resulted in significant increases in screen-detected cancers and specificity. However, no significant change was observed in the rate, size, node status, or grade of interval cancers. ClinicalTrials.gov: NCT01248546.

On reporting results from randomized controlled trials with recurrent events

Directory of Open Access Journals (Sweden)

Sobolev Boris G

2008-05-01

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

Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series.

Science.gov (United States)

Adam, Gaelen P; Springs, Stacey; Trikalinos, Thomas; Williams, John W; Eaton, Jennifer L; Von Isenburg, Megan; Gierisch, Jennifer M; Wilson, Lisa M; Robinson, Karen A; Viswanathan, Meera; Middleton, Jennifer Cook; Forman-Hoffman, Valerie L; Berliner, Elise; Kaplan, Robert M

2018-04-16

We investigated whether information in ClinicalTrials.gov would impact the conclusions of five ongoing systematic reviews. We considered five reviews that included 495 studies total. Each review team conducted a search of ClinicalTrials.gov up to the date of the review's last literature search, screened the records using the review's eligibility criteria, extracted information, and assessed risk of bias and applicability. Each team then evaluated the impact of the evidence found in ClinicalTrials.gov on the conclusions in the review. Across the five reviews, the number of studies that had both a registry record and a publication varied widely, from none in one review to 43% of all studies identified in another. Among the studies with both a record and publication, there was also wide variability in the match between published outcomes and those listed in ClinicalTrials.gov. Of the 173 total ClinicalTrials.gov records identified across the five projects, between 11 and 43% did not have an associated publication. In the 14% of records that contained results, the new data provided in the ClinicalTrials.gov records did not change the results or conclusions of the reviews. Finally, a large number of published studies were not registered in ClinicalTrials.gov, but many of these were published before ClinicalTrials.gov's inception date of 2000. Improved prospective registration of trials and consistent reporting of results in ClinicalTrials.gov would help make ClinicalTrials.gov records more useful in finding unpublished information and identifying potential biases. In addition, consistent indexing in databases, such as MEDLINE, would allow for better matching of records and publications, leading to increased utility of these searches for systematic review projects.

Results from four Pinus patula water planting trials in the summer ...

African Journals Online (AJOL)

Planting with water is used by some forestry companies in South Africa to reduce post-planting water stress. Four trials were implemented to test the response in survival of Pinus patula to water applied at planting. Two trials each were situated in the KwaZulu-Natal Midlands and Mpumalanga escarpment. The first trial at ...

Combining auctions and performance-based payments in a forest enrichment field trial in Western Kenya.

Science.gov (United States)

Khalumba, Mercelyne; Wünscher, Tobias; Wunder, Sven; Büdenbender, Mirjam; Holm-Müller, Karin

2014-06-01

Cost-effectiveness is an important aspect in the assessment of payments for environmental services (PES) initiatives. In participatory field trials with communities in Western Kenya, we combined procurement auctions for forest enrichment contracts with performance-based payments and compared the outcomes with a baseline scenario currently used by the Kenyan Forest Service. Procurement auctions were the most cost-effective. The competitive nature of the auction reduced contracting expenses (provision costs), and the result-oriented payments provided additional incentives to care for the planted seedlings, resulting in their improved survival rates (service quantity). These gains clearly exceeded increases in transaction costs associated with conducting an auction. The number of income-poor auction participants and winners was disproportionately high and local institutional buy-in was remarkably strong. Our participatory approach may, however, require adaptations when conducted at a larger scale. Although the number of contracts we monitored was limited and prohibited the use of statistical tests, our study is one of the first to reveal the benefits of using auctions for PES in developing countries. © 2014 Society for Conservation Biology.

Gestational Weight Gain: Results from the Delta Healthy Sprouts Comparative Impact Trial

Directory of Open Access Journals (Sweden)

Jessica L. Thomson

2016-01-01

Full Text Available Introduction. Delta Healthy Sprouts trial was designed to test the comparative impact of two home visiting programs on weight status, dietary intake, and health behaviors of Southern African American women and their infants. Results pertaining to the primary outcome, gestational weight gain, are reported. Methods. Participants (n=82, enrolled early in their second trimester of pregnancy, were randomly assigned to one of two treatment arms. Gestational weight gain, measured at six monthly home visits, was calculated by subtracting measured weight at each visit from self-reported prepregnancy weight. Weight gain was classified as under, within, or exceeding the Institute of Medicine recommendations based on prepregnancy body mass index. Chi-square tests and generalized linear mixed models were used to test for significant differences in percentages of participants within recommended weight gain ranges. Results. Differences in percentages of participants within the gestational weight gain guidelines were not significant between treatment arms across all visits. Conclusions. Enhancing the gestational nutrition and physical activity components of an existing home visiting program is feasible in a high risk population of primarily low income African American women. The impact of these enhancements on appropriate gestational weight gain is questionable given the more basic living needs of such women. This trial is registered with ClinicalTrials.gov NCT01746394, registered 4 December 2012.

Guided Web-Based Cognitive Behavior Therapy for Perfectionism: Results From Two Different Randomized Controlled Trials.

Science.gov (United States)

Rozental, Alexander; Shafran, Roz; Wade, Tracey D; Kothari, Radha; Egan, Sarah J; Ekberg, Linda; Wiss, Maria; Carlbring, Per; Andersson, Gerhard

2018-04-26

Perfectionism can become a debilitating condition that may negatively affect functioning in multiple areas, including mental health. Prior research has indicated that internet-based cognitive behavioral therapy can be beneficial, but few studies have included follow-up data. The objective of this study was to explore the outcomes at follow-up of internet-based cognitive behavioral therapy with guided self-help, delivered as 2 separate randomized controlled trials conducted in Sweden and the United Kingdom. In total, 120 participants randomly assigned to internet-based cognitive behavioral therapy were included in both intention-to-treat and completer analyses: 78 in the Swedish trial and 62 in the UK trial. The primary outcome measure was the Frost Multidimensional Perfectionism Scale, Concern over Mistakes subscale (FMPS CM). Secondary outcome measures varied between the trials and consisted of the Clinical Perfectionism Questionnaire (CPQ; both trials), the 9-item Patient Health Questionnaire (PHQ-9; Swedish trial), the 7-item Generalized Anxiety Disorder scale (GAD-7; Swedish trial), and the 21-item Depression Anxiety Stress Scale (DASS-21; UK trial). Follow-up occurred after 6 months for the UK trial and after 12 months for the Swedish trial. Analysis of covariance revealed a significant difference between pretreatment and follow-up in both studies. Intention-to-treat within-group Cohen d effect sizes were 1.21 (Swedish trial; 95% CI 0.86-1.54) and 1.24 (UK trial; 95% CI 0.85-1.62) for the FMPS CM. Furthermore, 29 (59%; Swedish trial) and 15 (43%; UK trial) of the participants met the criteria for recovery on the FMPS CM. Improvements were also significant for the CPQ, with effect sizes of 1.32 (Swedish trial; 95% CI 0.97-1.66) and 1.49 (UK trial; 95% CI 1.09-1.88); the PHQ-9, effect size 0.60 (95% CI 0.28-0.92); the GAD-7, effect size 0.67 (95% CI 0.34-0.99); and the DASS-21, effect size 0.50 (95% CI 0.13-0.85). The results are promising for the use of

Successful field trial of a multi-process phytoremediation system for remediation of petroleum impacted soils

Energy Technology Data Exchange (ETDEWEB)

Reid, N. [EBA Engineering Consultants Ltd., Calgary, AB (Canada); Greenberg, B.M. [Waterloo Univ., ON (Canada)]|[Waterloo Environmental Biotechnology Inc., Waterloo, ON (Canada)

2007-07-01

This presentation described a field trial of a new phytoremediation technology. The multi process phytoremediation system (MPPS) was designed for use in physical soil treatment and used seeds inoculated with plant growth promoting rhizobacteria (PGPR). The technology aerated the soil and photo-oxidized petroleum hydrocarbons (PHC) by exposing them to the light. In this study, 2 natural non-pathogenic strains of Pseudomonas putida were applied to seeds prior to planting. PGPR was used to create conditions suitable for the biodegradation of PHC, while also preserving natural soil structure and texture. High levels of microbial biomass in the soil were achieved. The presentation also provided details of a field study conducted in Hinton, Alberta which established vegetation in the treatment area in order to reduce PHC levels. The area was contaminated with compost invert drilling mud (CIDM) that had previously and unsuccessfully been treated with a biopile. The treatment plan consisted of aeration, soil sampling, and seeding. Soil and vegetation sampling was also conducted. Results of the study showed the vegetation was well established using the technique, and reduced hydrocarbon levels by between 17 and 53 per cent. It was concluded that continued hydrocarbon reduction levels are anticipated using the technology. tabs., figs.

Example-based illustrations of design, conduct, analysis and result interpretation of multi-regional clinical trials.

Science.gov (United States)

Quan, Hui; Mao, Xuezhou; Tanaka, Yoko; Binkowitz, Bruce; Li, Gang; Chen, Josh; Zhang, Ji; Zhao, Peng-Liang; Ouyang, Soo Peter; Chang, Mark

2017-07-01

Extensive research has been conducted in the Multi-Regional Clinical Trial (MRCT) area. To effectively apply an appropriate approach to a MRCT, we need to synthesize and understand the features of different approaches. In this paper, examples are used to illustrate considerations regarding design, conduct, analysis and interpretation of result of MRCTs. We start with a brief discussion of region definitions and the scenarios where different regions have differing requirements for a MRCT. We then compare different designs and models as well as the corresponding interpretation of the results. We highlight the importance of paying special attention to trial monitoring and conduct to prevent potential issues associated with the final trial results. Besides evaluating the overall treatment effect for the entire MRCT, we also consider other key analyses including quantification of regional treatment effects within a MRCT, and assessment of consistency of these regional treatment effects. Copyright © 2017 Elsevier Inc. All rights reserved.

Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey

Directory of Open Access Journals (Sweden)

Houston Helen

2010-12-01

Full Text Available Abstract Background Hundreds of thousands of volunteers take part in medical research, but many will never hear from researchers about what the study revealed. There is a growing demand for the results of randomised trials to be fed back to research participants both for ethical research practice and for ensuring their co-operation in a trial. This study aims to determine participants' preferences for type of leaflet (short versus long used to summarise the findings of a randomised trial; and to test whether certain characteristics explained participants' preferences. Methods 553 participants in a randomised trial about General Practitioners' access to Magnetic Resonance Imaging for patients presenting with suspected internal derangement of the knee were asked in the final follow-up questionnaire whether they would like to be fed back the results of the trial. Participants who agreed to this were included in a postal questionnaire survey asking about their preference, if any, between a short and a long leaflet and what it was about the leaflet that they preferred. Multinomial logistic regression was used to test whether certain demographics of responding participants along with treatment group explained whether a participant had a preference for type of leaflet or no preference. Results Of the participants who returned the final follow-up questionnaire, 416 (88% agreed to receive the results of the trial. Subsequently 132 (32% participants responded to the survey. Most participants preferred the longer leaflet (55% and the main reasons for this were the use of technical information (94% and diagrams (89%. There was weak evidence to suggest that gender might explain whether participants have a preference for type of leaflet or not (P = 0.084. Conclusions Trial participants want to receive feed back about the results and appear to prefer a longer leaflet. Males and females might require information to be communicated to them differently and should

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

Science.gov (United States)

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

2010-01-01

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

Cervical spine disease may result in a negative lumbar spinal drainage trial in normal pressure hydrocephalus: case report.

Science.gov (United States)

Komotar, Ricardo J; Zacharia, Brad E; Mocco, J; Kaiser, Michael G; Frucht, Stephen J; McKhann, Guy M

2008-10-01

In this case report, we present a patient with normal pressure hydrocephalus in whom a lumbar drainage trial yielded a false-negative result secondary to cervical spondylosis. An 80-year-old woman presented with classic symptoms of normal pressure hydrocephalus as well as evidence of cervical myelopathy. Magnetic resonance imaging of the brain and spine showed enlarged ventricles and single-level cervical canal narrowing. An initial lumbar drainage trial was performed, which revealed negative results. The patient then underwent cervical decompression and fusion. Despite this procedure, the patient's symptoms continued to worsen. A repeat lumbar drainage trial was performed with positive results. Subsequently, a ventriculoperitoneal shunt was placed, resulting in significant improvement of her symptoms. This case report illustrates how altered cerebrospinal fluid flow dynamics may impact the accuracy of the lumbar spinal drainage trial in patients with normal pressure hydrocephalus.

Contradictory results on the effects of magnetic fields

International Nuclear Information System (INIS)

Jokela, K.

1994-01-01

Magnetic fields are becoming a new problem for the authorities, because some studies indicate that they increase the risk of cancer. On the other hand, experimental studies with animals and cell cultures have not proved that magnetic fields can definitively cause cancer. The results of studies may, in fact, be misleading. The cancer risk seems to increase randomly, because there are usually no more than twenty or thirty people with cancer among the study population. Often the types of cancer vary even though the exposure conditions have been similar. It is also possible that some unknown factor associated with power lines and equipment increases the cancer risk. People are usually exposed to magnetic fields induced by the electricity network and electrical appliances in buildings. Magnetic fields can be reduced during the design of electrical installations and appliances; this is much easier than the reduction of existing fields. It is also relatively easy to limit magnetic fields caused by VDU's and many electrical appliances during the design phase. (orig.)

Radiotherapy with or without hyperthermia in the treatment of superficial localized breast cancer: results from five randomized controlled trials

International Nuclear Information System (INIS)

Vernon, Clare C.; Hand, Jeffrey W.; Field, Stanley B.; Machin, David; Whaley, Jill B.; Zee, Jacoba van der; Putten, Wim L.J. van; Rhoon, Gerard C. van; Dijk, Jan D.P. van; Gonzalez, Dionisio Gonzalez; Liu, F.-F.; Goodman, Phyllis; Sherar, Michael

1996-01-01

Purpose: Claims for the value of hyperthermia as an adjunct to radiotherapy in the treatment of cancer have mostly been based on small Phase I or II trials. To test the benefit of this form of treatment, randomized Phase III trials were needed. Methods and Materials: Five randomized trials addressing this question were started between 1988 and 1991. In these trials, patients were eligible if they had advanced primary or recurrent breast cancer, and local radiotherapy was indicated in preference to surgery. In addition, heating of the lesions and treatment with a prescribed (re)irradiation schedule had to be feasible and informed consent was obtained. The primary endpoint of all trials was local complete response. Slow recruitment led to a decision to collaborate and combine the trial results in one analysis, and report them simultaneously in one publication. Interim analyses were carried out and the trials were closed to recruitment when a previously agreed statistically significant difference in complete response rate was observed in the two larger trials. Results: We report on pretreatment characteristics, the treatments received, the local response observed, duration of response, time to local failure, distant progression and survival, and treatment toxicity of the 306 patients randomized. The overall CR rate for RT alone was 41% and for the combined treatment arm was 59%, giving, after stratification by trial, an odds ratio of 2.3. Not all trials demonstrated an advantage for the combined treatment, although the 95% confidence intervals of the different trials all contain the pooled odds ratio. The greatest effect was observed in patients with recurrent lesions in previously irradiated areas, where further irradiation was limited to low doses. Conclusion: The combined result of the five trials has demonstrated the efficacy of hyperthermia as an adjunct to radiotherapy for treatment of recurrent breast cancer. The implication of these encouraging results is that

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

Science.gov (United States)

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

2011-05-06

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

'It looks like you just want them when things get rough': civil society perspectives on negative trial results and stakeholder engagement in HIV prevention trials.

Science.gov (United States)

Koen, Jennifer; Essack, Zaynab; Slack, Catherine; Lindegger, Graham; Newman, Peter A

2013-12-01

Civil society organizations (CSOs) have significantly impacted on the politics of health research and the field of bioethics. In the global HIV epidemic, CSOs have served a pivotal stakeholder role. The dire need for development of new prevention technologies has raised critical challenges for the ethical engagement of community stakeholders in HIV research. This study explored the perspectives of CSO representatives involved in HIV prevention trials (HPTs) on the impact of premature trial closures on stakeholder engagement. Fourteen respondents from South African and international CSOs representing activist and advocacy groups, community mobilisation initiatives, and human and legal rights groups were purposively sampled based on involvement in HPTs. Interviews were conducted from February-May 2010. Descriptive analysis was undertaken across interviews and key themes were developed inductively. CSO representatives largely described positive outcomes of recent microbicide and HIV vaccine trial terminations, particularly in South Africa, which they attributed to improvements in stakeholder engagement. Ongoing challenges to community engagement included the need for principled justifications for selective stakeholder engagement at strategic time-points, as well as the need for legitimate alternatives to CABs as mechanisms for engagement. Key issues for CSOs in relation to research were also raised. © 2012 John Wiley & Sons Ltd.

A data grid for imaging-based clinical trials

Science.gov (United States)

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

2007-03-01

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.

Hodgkin's disease in children: Treatment with MOPP and low-dose, extended field irradiation without laparotomy. Late results and toxicity

International Nuclear Information System (INIS)

Jenkin, D.; Doyle, J.; Berry, M.; Blanchette, V.; Chan, H.; Doherty, M.; Freedman, M.; Greenberg, M.; Panzarella, T.; Saunders, F.

1990-01-01

The 10 year results of a trial of bimodal treatment of Hodgkin's disease in children with 6 cycles of MOPP and low-dose extended field irradiation, without staging laparotomy, were for 57 children in all stages as follows: survival 85%, relapse-free survival 80%, and survival-free of second relapse 86%. There were three fatal toxic events, two due to viral infection and one to a second malignant tumor (NHL). Three other patients developed a second malignant tumour, and one developed a thyroid adenoma. No patient developed acute leukemia. These results are compared with the results of treatment of surgically staged children by extended field irradiation alone, with bimodal treatment reserved for relapse or advanced disease at diagnosis. Initial bimodal treatment improved the overall 10 year survival free from a second relapse rate by 20% (86% vs. 66%). No major difference in treatment toxicity between these two groups has emerged during the first 10 years of follow-up. We conclude that, except for favourable CS-1 presentations, children with Hodgkin's disease confined to the lymphatic system should be given bimodal treatment, but that the least morbid effective combination remains to be determined

Publication Trend of Clinical Trials with Negative Results Funded by Pharmaceutical Industries for the 2007-2012 Period

Directory of Open Access Journals (Sweden)

Evert A. Jiménez-Cotes

2015-01-01

Full Text Available Abstract: Objective: To evaluate the results of clinical trials financed by the pharmaceutical industries during the period 2007-2012 in a general medical journal. Materials and methods: We performed an observational cross sectional study where originals clinical trials financed by the pharmaceutical industry published between 2007 and 2012 in the journal The New England Journal of Medicine (http://www.nejm.org were reviewed. Trend Chi2 test was used to evaluate the results of studies over the years. A database was created with different variables, identifying the number of publications and the period of greater publishing negatives studies, as well as the medical specialty and pharmaceutical industry funding. Results: 321 clinical trials were analyzed. The Odds Ratio was calculated for each year evaluated, finding a Chi2 of linear trend in negatives studies of 2.91 with value p 0.08 and positive studies of 1.16 with value p 0.28. It was found that in the period 2007-2009 123 studies were published, 40 % of which presented negative results; unlike the 2010-2012 period in which 198 clinical trials where published, 142 of them, showed positive results, OR 1.68, 95 % CI (1.02-2.78 value p 0.03. The highest figures of negative results were published in 2007: 44.7 %. Conclusions: A progressive decrease in the number of publications with annual general negative results has been observed. A statistically significant difference in the publication of negative studies per year was not found between the periods 2007-2012. The medical specialty that showed the largest number of total and negative publications in both periods was cardiology. The pharmaceutical industry that sponsored most total clinical trials with negative results in both periods did so through Merck, Glaxo SmithKline, and Sanofi-Aventis. 50% of neurology publications showed negative results.

Eurados trial performance test for neutron personal dosimetry

DEFF Research Database (Denmark)

Bordy, J.M.; Stadtmann, H.; Ambrosi, P.

2001-01-01

This paper reports on the results of a neutron trial performance test sponsored by the European Commission and organised by EURADOS. As anticipated, neutron dosimetry results were very dependent on the dosemeter type and the dose calculation algorithm. Fast neutron fields were generally well...

Planning and analyzing clinical trials with composite endpoints

CERN Document Server

Rauch, Geraldine; Kieser, Meinhard

2017-01-01

This book addresses the most important aspects of how to plan and evaluate clinical trials with a composite primary endpoint to guarantee a clinically meaningful and valid interpretation of the results. Composite endpoints are often used as primary efficacy variables for clinical trials, particularly in the fields of oncology and cardiology. These endpoints combine several variables of interest within a single composite measure, and as a result, all variables that are of major clinical relevance can be considered in the primary analysis without the need to adjust for multiplicity. Moreover, composite endpoints are intended to increase the size of the expected effects thus making clinical trials more powerful. The book offers practical advice for statisticians and medical experts involved in the planning and analysis of clinical trials. For readers who are mainly interested in the application of the methods, all the approaches are illustrated with real-world clinical trial examples, and the software codes requ...

Clinical trials for stem cell therapies

Directory of Open Access Journals (Sweden)

Lomax Geoff

2011-05-01

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

TOTAL REPLACEMENT OF FISHMEAL WITH AN ORGANICALLY CERTIFIED YEAST–BASED PROTEIN IN PACIFIC WHITE SHRIMP (Litopenaeus Vannamei DIETS: LABORATORY AND FIELD TRIALS

Directory of Open Access Journals (Sweden)

Ewen McLean

2006-04-01

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.

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.

1997-01-01

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)

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

Science.gov (United States)

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

2016-09-01

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

Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey.

Science.gov (United States)

Brealey, Stephen; Andronis, Lazaros; Dennis, Laura; Atwell, Christine; Bryan, Stirling; Coulton, Simon; Cox, Helen; Cross, Ben; Fylan, Fiona; Garratt, Andrew; Gilbert, Fiona; Gillan, Maureen; Hendry, Maggie; Hood, Kerenza; Houston, Helen; King, David; Morton, Veronica; Robling, Michael; Russell, Ian; Wilkinson, Clare

2010-12-01

Hundreds of thousands of volunteers take part in medical research, but many will never hear from researchers about what the study revealed. There is a growing demand for the results of randomised trials to be fed back to research participants both for ethical research practice and for ensuring their co-operation in a trial. This study aims to determine participants' preferences for type of leaflet (short versus long) used to summarise the findings of a randomised trial; and to test whether certain characteristics explained participants' preferences. 553 participants in a randomised trial about General Practitioners' access to Magnetic Resonance Imaging for patients presenting with suspected internal derangement of the knee were asked in the final follow-up questionnaire whether they would like to be fed back the results of the trial. Participants who agreed to this were included in a postal questionnaire survey asking about their preference, if any, between a short and a long leaflet and what it was about the leaflet that they preferred. Multinomial logistic regression was used to test whether certain demographics of responding participants along with treatment group explained whether a participant had a preference for type of leaflet or no preference. Of the participants who returned the final follow-up questionnaire, 416 (88%) agreed to receive the results of the trial. Subsequently 132 (32%) participants responded to the survey. Most participants preferred the longer leaflet (55%) and the main reasons for this were the use of technical information (94%) and diagrams (89%). There was weak evidence to suggest that gender might explain whether participants have a preference for type of leaflet or not (P = 0.084). Trial participants want to receive feed back about the results and appear to prefer a longer leaflet. Males and females might require information to be communicated to them differently and should be the focus of further research. The trial is registered

IAEA workshop and field trial at the Oak Ridge K-25 Site

International Nuclear Information System (INIS)

Hembree, D.M. Jr.; Ross, H.H.; Carter, J.A.

1995-03-01

In March 1994, members of the International Safeguards Department in the National Security Program Office (NSPO) hosted an environmental monitoring field trial workshop for International Atomic Energy Agency (IAEA) inspectors. The workshop was held at the Oak Ridge K-25 Site and its primary purpose was to train the inspectors in the techniques needed for effective environmental sample collection and handling. The workshop emphasized both sampling theory and practice. First, detailed techniques for swipe, vegetation, soil, biota, and water-associated sampling were covered in the classroom. Subsequently, the inspectors were divided into three groups for actual sample collection in and around the K-25 locale. The collected samples were processed by the Department of Energy (DOE) Network of Analytical Laboratories using established analytical techniques. This activity is part of the IAEA ''Programme 93+2 in. assessment of measures to enhance IAEA safeguards

Field reliability of competence to stand trial opinions: How often do evaluators agree, and what do judges decide when evaluators disagree?

Science.gov (United States)

Gowensmith, W Neil; Murrie, Daniel C; Boccaccini, Marcus T

2012-04-01

Despite many studies that examine the reliability of competence to stand trial (CST) evaluations, few shed light on "field reliability," or agreement among forensic evaluators in routine practice. We reviewed 216 cases from Hawaii, which requires three separate evaluations from independent clinicians for each felony defendant referred for CST evaluation. Results revealed moderate agreement. In 71% of initial CST evaluations, all evaluators agreed about a defendant's competence or incompetence (kappa = .65). Agreement was somewhat lower (61%, kappa = .57) in re-evaluations of defendants who were originally found incompetent and sent for restoration services. We also examined the decisions judges made about a defendant's CST. When evaluators disagreed, judges tended to make decisions consistent with the majority opinion. But when judges disagreed with the majority opinion, they more often did so to find a defendant incompetent than competent, suggesting a generally conservative approach. Overall, results reveal moderate agreement among independent evaluators in routine practice. But we discuss the potential for standardized training and methodology to further improve the field reliability of CST evaluations.

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

Science.gov (United States)

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

2017-01-01

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

Results of a Prospective Echocardiography Trial in International Space Station Crew

Science.gov (United States)

Hamilton, Douglas R.; Sargsyan, Ashot E.; Martin, David; Garcia, Kathleen M.; Melton, Shannon; Feiverson, Alan; Dulchavsky, Scott A.

2009-01-01

In the framework of an operationally oriented investigation, we conducted a prospective trial of a standard clinical echocardiography protocol in a cohort of long-duration crewmembers. The resulting primary and processed data appear to have no precedents. Our tele-echocardiography paradigm, including just-in-time e-training methods, was also assessed. A critical review of the imaging technique, equipment and setting limitations, and quality assurance is provided, as well as the analysis of "space normal" data.

Exact results for integrable asymptotically-free field theories

CERN Document Server

Evans, J M; Evans, Jonathan M; Hollowood, Timothy J

1995-01-01

An account is given of a technique for testing the equivalence between an exact factorizable S-matrix and an asymptotically-free Lagrangian field theory in two space-time dimensions. The method provides a way of resolving CDD ambiguities in the S-matrix and it also allows for an exact determination of the physical mass in terms of the Lambda parameter of perturbation theory. The results for various specific examples are summarized. (To appear in the Proceedings of the Conference on Recent Developments in Quantum Field Theory and Statistical Mechanics, ICTP, Trieste, Easter 1995).

Decreased Lung Perfusion After Breast/Chest Wall Irradiation: Quantitative Results From a Prospective Clinical Trial

Energy Technology Data Exchange (ETDEWEB)

Liss, Adam L., E-mail: adamliss68@gmail.com [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Marsh, Robin B. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Kapadia, Nirav S. [Department of Radiation Oncology, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (United States); McShan, Daniel L. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Rogers, Virginia E. [Division of Nuclear Medicine, Department of Radiology, University of Michigan, Ann Arbor, Michigan (United States); Balter, James M.; Moran, Jean M.; Brock, Kristy K.; Schipper, Matt J.; Jagsi, Reshma [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Griffith, Kent A. [Biostatistics Unit, University of Michigan, Ann Arbor, Michigan (United States); Flaherty, Kevin R. [Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan (United States); Frey, Kirk A. [Division of Nuclear Medicine, Department of Radiology, University of Michigan, Ann Arbor, Michigan (United States); Pierce, Lori J. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States)

2017-02-01

Purpose: To quantify lung perfusion changes after breast/chest wall radiation therapy (RT) using pre- and post-RT single photon emission computed tomography/computed tomography (SPECT/CT) attenuation-corrected perfusion scans; and correlate decreased perfusion with adjuvant RT dose for breast cancer in a prospective clinical trial. Methods and Materials: As part of an institutional review board–approved trial studying the impact of RT technique on lung function in node-positive breast cancer, patients received breast/chest wall and regional nodal irradiation including superior internal mammary node RT to 50 to 52.2 Gy with a boost to the tumor bed/mastectomy scar. All patients underwent quantitative SPECT/CT lung perfusion scanning before RT and 1 year after RT. The SPECT/CT scans were co-registered, and the ratio of decreased perfusion after RT relative to the pre-RT perfusion scan was calculated to allow for direct comparison of SPECT/CT perfusion changes with delivered RT dose. The average ratio of decreased perfusion was calculated in 10-Gy dose increments from 0 to 60 Gy. Results: Fifty patients had complete lung SPECT/CT perfusion data available. No patient developed symptoms consistent with pulmonary toxicity. Nearly all patients demonstrated decreased perfusion in the left lung according to voxel-based analyses. The average ratio of lung perfusion deficits increased for each 10-Gy increment in radiation dose to the lung, with the largest changes in regions of lung that received 50 to 60 Gy (ratio 0.72 [95% confidence interval 0.64-0.79], P<.001) compared with the 0- to 10-Gy region. For each increase in 10 Gy to the left lung, the lung perfusion ratio decreased by 0.06 (P<.001). Conclusions: In the assessment of 50 patients with node-positive breast cancer treated with RT in a prospective clinical trial, decreased lung perfusion by SPECT/CT was demonstrated. Our study allowed for quantification of lung perfusion defects in a prospective cohort of

Dispersant trial at ANO-2: Results from a short-term trial prior to SG replacement

International Nuclear Information System (INIS)

Fruzzetti, K.; Frattini, P.; Robbins, P.; Miller, A.; Varrin, R.; Kreider, M.

2002-01-01

Corrosion products in the secondary side of pressurized water reactor (PWR) steam generators (SGs) primarily deposit on the SG tubes. These deposits can inhibit heat transfer, lead to thermal-hydraulic instabilities through blockage of tube supports, and create occluded regions where corrosive species can concentrate along tubes and in tube-to-tube support plate crevices. The performance of the SGs is compromised not only by formation of an insulating scale, but by the removal of tubes from service due to corrosion. A potential strategy for minimizing deposition of corrosion products on SG internal surfaces is to use an online dispersant to help prevent the corrosion products from adhering to the steam generator surfaces. By inhibiting the deposition of the corrosion products, the dispersant can facilitate more effective removal from the SGs via blowdown. This type of strategy has been employed at fossil boilers for many decades. However, due to the use of inorganic (sulfur and other impurities) polymerization initiators, polymeric dispersants had not been utilized in the nuclear industry. Only recently has a poly-acrylic acid dispersant, developed by BetzDearborn (PAA), been available that meets the criteria for nuclear application. This paper summarizes the results of the short-term PAA dispersant trial in Winter/Spring 2000, lasting approximately 3 months, performed at Arkansas nuclear one unit 2 (ANO-2)-including the chronology of the trial, the increase in blowdown iron removal efficiency with use of the dispersant, and observed effects on SG performance. (authors)

Dispersant trial at ANO-2: Results from a short-term trial prior to SG replacement

Energy Technology Data Exchange (ETDEWEB)

Fruzzetti, K.; Frattini, P. [Electric Power Research Inst., Palo Alto, CA (United States); Robbins, P. [Entergy Operations, Arkansas Nuclear One, Russellville, AR (United States); Miller, A. [Pedro Point Technology, Inc., Pacifica, CA (United States); Varrin, R.; Kreider, M. [Dominion Engineering Inc., McLean, VA (United States)

2002-07-01

Corrosion products in the secondary side of pressurized water reactor (PWR) steam generators (SGs) primarily deposit on the SG tubes. These deposits can inhibit heat transfer, lead to thermal-hydraulic instabilities through blockage of tube supports, and create occluded regions where corrosive species can concentrate along tubes and in tube-to-tube support plate crevices. The performance of the SGs is compromised not only by formation of an insulating scale, but by the removal of tubes from service due to corrosion. A potential strategy for minimizing deposition of corrosion products on SG internal surfaces is to use an online dispersant to help prevent the corrosion products from adhering to the steam generator surfaces. By inhibiting the deposition of the corrosion products, the dispersant can facilitate more effective removal from the SGs via blowdown. This type of strategy has been employed at fossil boilers for many decades. However, due to the use of inorganic (sulfur and other impurities) polymerization initiators, polymeric dispersants had not been utilized in the nuclear industry. Only recently has a poly-acrylic acid dispersant, developed by BetzDearborn (PAA), been available that meets the criteria for nuclear application. This paper summarizes the results of the short-term PAA dispersant trial in Winter/Spring 2000, lasting approximately 3 months, performed at Arkansas nuclear one unit 2 (ANO-2)-including the chronology of the trial, the increase in blowdown iron removal efficiency with use of the dispersant, and observed effects on SG performance. (authors)

The power of statistical tests using field trial count data of non-target organisms in enviromental risk assessment of genetically modified plants

NARCIS (Netherlands)

Voet, van der H.; Goedhart, P.W.

2015-01-01

Publications on power analyses for field trial count data comparing transgenic and conventional crops have reported widely varying requirements for the replication needed to obtain statistical tests with adequate power. These studies are critically reviewed and complemented with a new simulation

The Frontier Fields: Survey Design and Initial Results

Energy Technology Data Exchange (ETDEWEB)

Lotz, J. M.; Koekemoer, A.; Grogin, N.; Mack, J.; Anderson, J.; Avila, R.; Barker, E. A.; Borncamp, D.; Durbin, M.; Gunning, H.; Hilbert, B.; Jenkner, H.; Khandrika, H.; Levay, Z.; Lucas, R. A.; MacKenty, J.; Ogaz, S. [Space Telescope Science Institute, 3700 San Martin Drive, Baltimore, MD 21218 (United States); Coe, D.; Capak, P.; Brammer, G., E-mail: lotz@stsci.edu [European Space Agency/Space Telescope Science Institute, 3700 Sam Martin Drive, Baltimore, MD 21218 (United States); and others

2017-03-01

What are the faintest distant galaxies we can see with the Hubble Space Telescope ( HST ) now, before the launch of the James Webb Space Telescope ? This is the challenge taken up by the Frontier Fields, a Director’s discretionary time campaign with HST and the Spitzer Space Telescope to see deeper into the universe than ever before. The Frontier Fields combines the power of HST and Spitzer with the natural gravitational telescopes of massive high-magnification clusters of galaxies to produce the deepest observations of clusters and their lensed galaxies ever obtained. Six clusters—Abell 2744, MACSJ0416.1-2403, MACSJ0717.5+3745, MACSJ1149.5+2223, Abell S1063, and Abell 370—have been targeted by the HST ACS/WFC and WFC3/IR cameras with coordinated parallel fields for over 840 HST orbits. The parallel fields are the second-deepest observations thus far by HST with 5 σ point-source depths of ∼29th ABmag. Galaxies behind the clusters experience typical magnification factors of a few, with small regions magnified by factors of 10–100. Therefore, the Frontier Field cluster HST images achieve intrinsic depths of ∼30–33 mag over very small volumes. Spitzer has obtained over 1000 hr of Director’s discretionary imaging of the Frontier Field cluster and parallels in IRAC 3.6 and 4.5 μ m bands to 5 σ point-source depths of ∼26.5, 26.0 ABmag. We demonstrate the exceptional sensitivity of the HST Frontier Field images to faint high-redshift galaxies, and review the initial results related to the primary science goals.

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

Science.gov (United States)

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

2015-01-01

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

Reliability of kinetic visual field testing in children with mutation-proven retinal dystrophies: Implications for therapeutic clinical trials.

Science.gov (United States)

Dedania, Vaidehi S; Liu, Jerry Y; Schlegel, Dana; Andrews, Chris A; Branham, Kari; Khan, Naheed W; Musch, David C; Heckenlively, John R; Jayasundera, K Thiran

2018-01-01

Kinetic visual field testing is used to monitor disease course in retinal dystrophy clinical care and treatment response in treatment trials, which are increasingly recruiting children. This study investigates Goldmann visual field (GVF) changes in young children with mutation-proven retinal dystrophies as they age and with progression of the retinal degeneration. Retrospective review of children ≤ 17 years old with a mutation-proven retinal dystrophy. Objective clinical disease activity was assessed by a retinal degeneration specialist masked to GVF results. Digital quantification of GVF area was performed. Twenty-nine children (58 eyes), ages 5-16, were identified. GVF area increased with age despite progression in 20 children and clinical stability in nine children. Mean ± standard error increase in GVF area/year was 333 ± 130 mm 2 (I4e, p = 0.012), 720 ± 155 mm 2 (III4e, p children with mutation-proven retinal dystrophies, there is a significant increase in GVF area with age, particularly those children with retinal dystrophies can be an unreliable measure of response to treatment and on which to base appropriate counseling about visual impairment.

Stock market returns and clinical trial results of investigational compounds: an event study analysis of large biopharmaceutical companies.

Science.gov (United States)

Hwang, Thomas J

2013-01-01

For biopharmaceutical companies, investments in research and development are risky, and the results from clinical trials are key inflection points in the process. Few studies have explored how and to what extent the public equity market values clinical trial results. Our study dataset matched announcements of clinical trial results for investigational compounds from January 2011 to May 2013 with daily stock market returns of large United States-listed pharmaceutical and biotechnology companies. Event study methodology was used to examine the relationship between clinical research events and changes in stock returns. We identified public announcements for clinical trials of 24 investigational compounds, including 16 (67%) positive and 8 (33%) negative events. The majority of announcements were for Phase 3 clinical trials (N = 13, 54%), and for oncologic (N = 7, 29%) and neurologic (N = 6, 24%) indications. The median cumulative abnormal returns on the day of the announcement were 0.8% (95% confidence interval [CI]: -2.3, 13.4%; P = 0.02) for positive events and -2.0% (95% CI: -9.1, 0.7%; P = 0.04) for negative events, with statistically significant differences from zero. In the day immediately following the announcement, firms with positive events were associated with stock price corrections, with median cumulative abnormal returns falling to 0.4% (95% CI: -3.8, 12.3%; P = 0.33). For firms with negative announcements, the median cumulative abnormal returns were -1.7% (95% CI: -9.5, 1.0%; P = 0.03), and remained significantly negative over the two day event window. The magnitude of abnormal returns did not differ statistically by indication, by trial phase, or between biotechnology and pharmaceutical firms. The release of clinical trial results is an economically significant event and has meaningful effects on market value for large biopharmaceutical companies. Stock return underperformance due to negative events is greater in magnitude and persists longer than

Ship-to-Ship Radiocommunication Trial by Using Wireless LAN

Directory of Open Access Journals (Sweden)

Yasuyuki Niwa

2015-12-01

In a former field radiocommunication trial, omni-directional antennas were used and a few hundred kbps throughput between two ships was measured, which was not enough for our research target (over 1Mbps. In order to get faster throughput, a field radiocommunication trial was carried out again with a few types of directional antennas and RSSI (Received Signal Strength Indication and the throughput between two ships was measured simultaneously. As a result, multi-path (2-path model affected by the reflection of the sea surface was confirmed and also the characteristics of the directional antennas such as half-power angle were confirmed, but the measured throughput was fast enough to meet our expectation.

Field trials show the fertilizer value of nitrogen in irrigation water

Directory of Open Access Journals (Sweden)

Mike Cahn

2017-04-01

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.

Dosimetry audit for a multi-centre IMRT head and neck trial

International Nuclear Information System (INIS)

Clark, Catharine H.; Hansen, Vibeke Nordmark; Chantler, Hannah; Edwards, Craig; James, Hayley V.; Webster, Gareth; Miles, Elizabeth A.; Guerrero Urbano, M. Teresa; Bhide, Shree A.; Bidmead, A. Margaret; Nutting, Christoper M.

2009-01-01

Background and purpose: PARSPORT was a multi-centre randomised trial in the UK which compared Intensity-Modulated Radiotherapy (IMRT) and conventional radiotherapy (CRT) for patients with head and neck cancer. The dosimetry audit goals were to verify the plan delivery in participating centres, ascertain what tolerances were suitable for head and neck IMRT trials and develop an IMRT credentialing program. Materials and methods: Centres enrolling patients underwent rigorous quality assurance before joining the trial. Following this each centre was visited for a dosimetry audit, which consisted of treatment planning system tests, fluence verification films, combined field films and dose point measurements. Results: Mean dose point measurements were made at six centres. For the primary planning target volume (PTV) the differences with the planned values for the IMRT and CRT arms were -0.6% (1.8% to -2.4%) and 0.7% (2.0% to -0.9%), respectively. Ninety-four percent of the IMRT fluence films for individual fields passed gamma criterion of 3%/3 mm and 75% of the films for combined fields passed gamma criterion 4%/3 mm (no significant difference between dynamic delivery and step and shoot delivery). Conclusions: This audit suggests that a 3% tolerance could be applied for PTV point doses. For dose distributions tolerances of 3%/3 mm on individual fields and 4%/3 mm for combined fields are proposed for multi-centre head and neck IMRT trials.

The Auroral Field-aligned Acceleration - Cluster Results

Science.gov (United States)

Vaivads, A.; Cluster Auroral Team

The four Cluster satellites cross the auroral field lines at altitudes well above most of acceleration region. Thus, the orbit is appropriate for studies of the generator side of this region. We consider the energy transport towards the acceleration region and different mechanisms for generating the potential drop. Using data from Cluster we can also for the first time study the dynamics of the generator on a minute scale. We present data from a few auroral field crossings where Cluster are in conjunction with DMSP satellites. We use electric and magnetic field data to estimate electrostatic po- tential along the satellite orbit, Poynting flux as well as the presence of plasma waves. These we can compare with data from particle and wave instruments on Cluster and on low latitude satellites to try to make a consistent picture of the acceleration region formation in these cases. Preliminary results show close agreement both between in- tegrated potential values at Cluster and electron peak energies at DMSP as well as close agreement between the integrated Poynting flux values at Cluster and the elec- tron energy flux at DMSP. At the end we draw a parallels between auroral electron acceleration and electron acceleration at the magnetopause.

Weathering of oils at sea: model/field data comparisons

International Nuclear Information System (INIS)

Daling, Per S.; Stroem, Tove

1999-01-01

The SINTEF Oil Weathering Model (OWM) has been extensively tested with results from full-scale field trials with experimental oil slicks in the Norwegian NOFO Sea trials in 1994 and 1995 and the AEA 1997 trials in UK. The comparisons between oil weathering values predicted by the model and ground-truth obtained from the field trials are presented and discussed. Good laboratory weathering data of the specific oil as input to the model is essential for obtaining reliable weathering predictions. Predications provided by the SINTEF-OWM enable oil spill personnel to estimate the most appropriate 'window of opportunity' for use of chemical dispersants under various spill situations. Pre-spill scenario analysis with the SINTEF Oil Spill Contingency and Response (OSCAR) model system, in which the SINTEF-OWM is one of several components, has become an important part of contingency plans as well as contingency training of oil spill personnel at refineries, oil terminals and offshore installations in Norway. (Author)

Measurement model choice influenced randomized controlled trial results.

Science.gov (United States)

Gorter, Rosalie; Fox, Jean-Paul; Apeldoorn, Adri; Twisk, Jos

2016-11-01

In randomized controlled trials (RCTs), outcome variables are often patient-reported outcomes measured with questionnaires. Ideally, all available item information is used for score construction, which requires an item response theory (IRT) measurement model. However, in practice, the classical test theory measurement model (sum scores) is mostly used, and differences between response patterns leading to the same sum score are ignored. The enhanced differentiation between scores with IRT enables more precise estimation of individual trajectories over time and group effects. The objective of this study was to show the advantages of using IRT scores instead of sum scores when analyzing RCTs. Two studies are presented, a real-life RCT, and a simulation study. Both IRT and sum scores are used to measure the construct and are subsequently used as outcomes for effect calculation. The bias in RCT results is conditional on the measurement model that was used to construct the scores. A bias in estimated trend of around one standard deviation was found when sum scores were used, where IRT showed negligible bias. Accurate statistical inferences are made from an RCT study when using IRT to estimate construct measurements. The use of sum scores leads to incorrect RCT results. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

1999-01-01

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.)

Leaching behaviour of incineration bottom ash in a reuse scenario: 12years-field data vs. lab test results.

Science.gov (United States)

Di Gianfilippo, Martina; Hyks, Jiri; Verginelli, Iason; Costa, Giulia; Hjelmar, Ole; Lombardi, Francesco

2018-03-01

Several types of standardized laboratory leaching tests have been developed during the past few decades to evaluate the leaching behaviour of waste materials as a function of different parameters, such as the pH of the eluate and the liquid to solid ratio. However, the link between the results of these tests and leaching data collected from the field (e.g. in disposal or reuse scenarios) is not always straightforward. In this work, we compare data obtained from an on-going large scale field trial, in which municipal solid waste incineration bottom ash is being tested as road sub-base material, with the results obtained from percolation column and pH-dependence laboratory leaching tests carried out on the bottom ash at the beginning of the test. The comparisons reported in this paper show that for soluble substances (e.g. Cl, K and SO 4 ), percolation column tests can provide a good indication of the release expected in the field with deviations usually within a factor of 3. For metals characterized by a solubility-controlled release, i.e. that depends more on eluate pH than the liquid to solid ratio applied, the results of pH-dependence tests describe more accurately the eluate concentration trends observed in the field with deviations that in most cases (around 80%) are within one order of magnitude (see e.g. Al and Cd). The differences between field and lab-scale data might be in part ascribed to the occurrence in the field of weathering reactions (e.g. carbonation) but also to microbial decomposition of organic matter that modifying leachate pH affect the solubility of several constituents (e.g. Ca, Ba and Cr). Besides, weathering reactions can result in enhanced adsorption of fulvic acids to iron/aluminum (hydr)oxides, leading to a decrease in the leaching of fulvic acids and hence of elements such as Cu, Ni and Pb that strongly depend on DOC leaching. Overall, this comparison shows that percolation column tests and pH-dependence tests can represent a reliable

Empirical trials of plant field guides.

Science.gov (United States)

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

2014-06-01

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

Translating laboratory compaction test results to field scale

NARCIS (Netherlands)

Roholl, J.A.; Thienen-Visser, K. van; Breunese, J.N.

2016-01-01

In recent studies on the surface subsidence caused by hydrocarbon recovery of the Groningen gas field, the predicted subsidence is overestimated if results of compaction experiments are not corrected by an empirical `upscaling factor'. In order to find an explanation for this `upscaling factor', an

The Results of a Randomized Control Trial Evaluation of the SPARK Literacy Program

Science.gov (United States)

Jones, Curtis J.; Christian, Michael; Rice, Andrew

2016-01-01

The purpose of this report is to present the results of a two-year randomized control trial evaluation of the SPARK literacy program. SPARK is an early grade literacy program developed by Boys & Girls Clubs of Greater Milwaukee. In 2010, SPARK was awarded an Investing in Innovation (i3) Department of Education grant to further develop the…

Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review.

Science.gov (United States)

Taljaard, Monica; Hemming, Karla; Shah, Lena; Giraudeau, Bruno; Grimshaw, Jeremy M; Weijer, Charles

2017-08-01

Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants-yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28

Achieving definitive results in long-chain polyunsaturated fatty acid supplementation trials of term infants: factors for consideration.

Science.gov (United States)

Meldrum, Suzanne J; Smith, Michael A; Prescott, Susan L; Hird, Kathryn; Simmer, Karen

2011-04-01

Numerous randomized controlled trials (RCTs) have been undertaken to determine whether supplementation with long-chain polyunsaturated fatty acids (LCPUFAs) in infancy would improve the developmental outcomes of term infants. The results of such trials have been thoroughly reviewed with no definitive conclusion as to the efficacy of LCPUFA supplementation. A number of reasons for the lack of conclusive findings in this area have been proposed. This review examines such factors with the aim of determining whether an optimal method of investigation for RCTs of LCPUFA supplementation in term infants can be ascertained from previous research. While more research is required to completely inform a method that is likely to achieve definitive results, the findings of this literature review indicate future trials should investigate the effects of sex, genetic polymorphisms, the specific effects of LCPUFAs, and the optimal tests for neurodevelopmental assessment. The current literature indicates a docosahexaenoic acid dose of 0.32%, supplementation from birth to 12 months, and a total sample size of at least 286 (143 per group) should be included in the methodology of future trials. © 2011 International Life Sciences Institute.

Results of the ANSWER Trial Using the PulseRider for the Treatment of Broad-Necked, Bifurcation Aneurysms.

Science.gov (United States)

Spiotta, Alejandro M; Derdeyn, Colin P; Tateshima, Satoshi; Mocco, Jay; Crowley, R Webster; Liu, Kenneth C; Jensen, Lee; Ebersole, Koji; Reeves, Alan; Lopes, Demetrius K; Hanel, Ricardo A; Sauvageau, Eric; Duckwiler, Gary; Siddiqui, Adnan; Levy, Elad; Puri, Ajit; Pride, Lee; Novakovic, Roberta; Chaudry, M Imran; Turner, Raymond D; Turk, Aquilla S

2017-07-01

The safety and probable benefit of the PulseRider (Pulsar Vascular, Los Gatos, California) for the treatment of broad-necked, bifurcation aneurysms was studied in the context of the prospective, nonrandomized, single arm clinical trial-the Adjunctive Neurovascular Support of Wide-neck aneurysm Embolization and Reconstruction (ANSWER) Trial. To present the results of the United States cases employing the PulseRider device as part of the ANSWER clinical trial. Aneurysms treated with the PulseRider device among sites enrolling in the ANSWER trial were prospectively studied and the results are summarized. Aneurysms arising at either the carotid terminus or basilar apex that were relatively broad necked were considered candidates for inclusion into the ANSWER study. Thirty-four patients were enrolled (29 female and 5 male) with a mean age of 60.9 years (27 basilar apex and 7 carotid terminus). Mean aneurysm height ranged from 2.4 to 15.9 mm with a mean neck size of 5.2 mm (range 2.3-11.6 mm). In all patients, the device was delivered and deployed. Immediate Raymond I or II occlusion was achieved in 82.4% and progressed to 87.9% at 6-month follow-up. A modified Rankin Score of 2 or less was seen in 94% of patients at 6 months. The results from the ANSWER trial demonstrate that the PulseRider device is safe and offers probable benefit as for the treatment of bifurcation aneurysms arising at the basilar apex or carotid terminus. As such, it represents a useful addition to the armamentarium of the neuroendovascular specialist. Copyright © 2017 by the Congress of Neurological Surgeons

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

Science.gov (United States)

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

2011-11-02

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

Variational methods for field theories

Energy Technology Data Exchange (ETDEWEB)

Ben-Menahem, S.

1986-09-01

Four field theory models are studied: Periodic Quantum Electrodynamics (PQED) in (2 + 1) dimensions, free scalar field theory in (1 + 1) dimensions, the Quantum XY model in (1 + 1) dimensions, and the (1 + 1) dimensional Ising model in a transverse magnetic field. The last three parts deal exclusively with variational methods; the PQED part involves mainly the path-integral approach. The PQED calculation results in a better understanding of the connection between electric confinement through monopole screening, and confinement through tunneling between degenerate vacua. This includes a better quantitative agreement for the string tensions in the two approaches. Free field theory is used as a laboratory for a new variational blocking-truncation approximation, in which the high-frequency modes in a block are truncated to wave functions that depend on the slower background modes (Boron-Oppenheimer approximation). This ''adiabatic truncation'' method gives very accurate results for ground-state energy density and correlation functions. Various adiabatic schemes, with one variable kept per site and then two variables per site, are used. For the XY model, several trial wave functions for the ground state are explored, with an emphasis on the periodic Gaussian. A connection is established with the vortex Coulomb gas of the Euclidean path integral approach. The approximations used are taken from the realms of statistical mechanics (mean field approximation, transfer-matrix methods) and of quantum mechanics (iterative blocking schemes). In developing blocking schemes based on continuous variables, problems due to the periodicity of the model were solved. Our results exhibit an order-disorder phase transition. The transfer-matrix method is used to find a good (non-blocking) trial ground state for the Ising model in a transverse magnetic field in (1 + 1) dimensions.

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

Directory of Open Access Journals (Sweden)

van den Hout Lieke

2011-11-01

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

Field line mapping results in the CNT stellarator

International Nuclear Information System (INIS)

Sarasola, X.; Pedersen, T. Sunn; Kremer, J.P.; Lefrancois, R.G.; Marksteiner, Q.; Ahmad, N.

2005-01-01

The Columbia Non-neutral Torus (CNT), located at Columbia University, is a toroidal, ultra-high vacuum stellarator designed to confine pure electron and other non-neutral plasmas. Its coil configuration is the simplest of any stellarator constructed, since it consists only of two pairs of circular planar copper coils. CNT started operation in November 2004. During its first months of operation a detailed mapping of the nested magnetic surfaces has been developed using the fluorescent method. An electron beam was emitted along a field line by a small moveable electron gun. Different beam energies (ranging from 50 to 200 eV) were used to perform the field line mapping. The e- beam emitted by the electron gun followed the field lines around the torus and hit two moveable ZnO coated aluminum rods that emit visible light when struck by the e-beam. For each position of the e- gun, the phosphor rods scanned the cross-section of the torus allowing a standard digital camera to record a single magnetic surface in a five second exposure. Multiple photos were taken and then manipulated and superposed using IDL software to create composite images of the nested magnetic surfaces. Detailed mapping of the magnetic flux surfaces was completed at a variety of magnetic configurations and at pressures in the 10 -8 Torr range. The experimental results were compared with numerical calculations demonstrating that the obtained measurements agree very well with numerical predictions. In particular, the current configuration has an ultralow aspect ratio (A≤ 1.9) and excellent magnetic surface quality with no detectable island structures or stochastic regions, except at the edge of the plasma where a predicted island chain is present. These experimental results will be presented along with details of the field line mapping system. (author)

Infant feeding bottle design, growth and behaviour: results from a randomised trial

Directory of Open Access Journals (Sweden)

Fewtrell MS

2012-03-01

Full Text Available Abstract Background Whether the design of an anti-vacuum infant feeding bottle influences infant milk intake, growth or behavior is unknown, and was the subject of this randomized trial. Methods Subjects 63 (36 male healthy, exclusively formula-fed term infants. Intervention Randomisation to use Bottle A (n = 31, one-way air valve: Philips Avent versus Bottle B (n = 32, internal venting system: Dr Browns. 74 breast-fed reference infants were recruited, with randomisation (n = 24 to bottle A (n = 11 or B (n = 13 if bottle-feeding was subsequently introduced. Randomisation stratified by gender and parity; computer-based telephone randomisation by independent clinical trials unit. Setting Infant home. Primary outcome measure infant weight gain to 4 weeks. Secondary outcomes (i milk intake (ii infant behaviour measured at 2 weeks (validated 3-day diary; (iii risk of infection; (iv continuation of breastfeeding following introduction of mixed feeding. Results Number analysed for primary outcome Bottle A n = 29, Bottle B n = 25. Primary outcome There was no significant difference in weight gain between randomised groups (0-4 weeks Bottle A 0.74 (SD 1.2 SDS versus bottle B 0.51 (0.39, mean difference 0.23 (95% CI -0.31 to 0.77. Secondary outcomes Infants using bottle A had significantly less reported fussing (mean 46 versus 74 minutes/day, p Breast-fed reference group There were no significant differences in primary or secondary outcomes between breast-fed and formula fed infants. The likelyhood of breastfeeding at 3 months was not significantly different in infants subsequently randomised to bottle A or B. Conclusion Bottle design may have short-term effects on infant behaviour which merit further investigation. No significant effects were seen on milk intake or growth; confidence in these findings is limited by the small sample size and this needs confirmation in a larger study. Trial registration Clinical Trials.gov NCT00325208.

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

NARCIS (Netherlands)

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

2014-01-01

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

Limited Chemotherapy and Shrinking Field Radiotherapy for Osteolymphoma (Primary Bone Lymphoma): Results From the Trans-Tasman Radiation Oncology Group 99.04 and Australasian Leukaemia and Lymphoma Group LY02 Prospective Trial

International Nuclear Information System (INIS)

Christie, David; Dear, Keith; Le, Thai; Barton, Michael; Wirth, Andrew; Porter, David; Roos, Daniel; Pratt, Gary

2011-01-01

Purpose: To establish benchmark outcomes for combined modality treatment to be used in future prospective studies of osteolymphoma (primary bone lymphoma). Methods and Materials: In 1999, the Trans-Tasman Radiation Oncology Group (TROG) invited the Australasian Leukemia and Lymphoma Group (ALLG) to collaborate on a prospective study of limited chemotherapy and radiotherapy for osteolymphoma. The treatment was designed to maintain efficacy but limit the risk of subsequent pathological fractures. Patient assessment included both functional imaging and isotope bone scanning. Treatment included three cycles of CHOP chemotherapy and radiation to a dose of 45 Gy in 25 fractions using a shrinking field technique. Results: The trial closed because of slow accrual after 33 patients had been entered. Accrual was noted to slow down after Rituximab became readily available in Australia. After a median follow-up of 4.3 years, the five-year overall survival and local control rates are estimated at 90% and 72% respectively. Three patients had fractures at presentation that persisted after treatment, one with recurrent lymphoma. Conclusions: Relatively high rates of survival were achieved but the number of local failures suggests that the dose of radiotherapy should remain higher than it is for other types of lymphoma. Disability after treatment due to pathological fracture was not seen.

PEGylated carboxyhemoglobin bovine (SANGUINATE): results of a phase I clinical trial.

Science.gov (United States)

Misra, Hemant; Lickliter, Jason; Kazo, Friedericke; Abuchowski, Abraham

2014-08-01

PEGylated carboxyhemoglobin bovine (SANGUINATE) is a dual action carbon monoxide releasing (CO)/oxygen (O2 ) transfer agent for the treatment of hypoxia. Its components inhibit vasoconstriction, decrease extravasation, limit reactive oxygen species production, enhance blood rheology, and deliver oxygen to the tissues. Animal models of cerebral ischemia, peripheral ischemia, and myocardial ischemia demonstrated SANGUINATE's efficacy in reducing myocardial infarct size, limiting necrosis from cerebral ischemia, and promoting more rapid recovery from hind limb ischemia. In a Phase I trial, three cohorts of eight healthy volunteers received single ascending doses of 80, 120, or 160 mg/kg of SANGUINATE. Two volunteers within each cohort served as a saline control. There were no serious adverse events. Serum haptoglobin decreased, but did not appear to be dose related. The T1/2 was dose dependent and ranged from 7.9 to 13.8 h. In addition to the Phase I trial, SANGUINATE was used under an expanded access emergency Investigational New Drug. SANGUINATE was found to be safe and well tolerated in a Phase I clinical trial, and therefore it will advance into further clinical trials in patients. © 2014 The Authors. Artificial Organs published by Wiley Periodicals, Inc. on behalf of International Center for Artificial Organs and Transplantation (ICAOT).

Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analyses

DEFF Research Database (Denmark)

Brok, J.; Thorlund, K.; Gluud, C.

2008-01-01

in 80% (insufficient information size). TSA(15%) and TSA(LBHIS) found that 95% and 91% had absence of evidence. The remaining nonsignificant meta-analyses had evidence of lack of effect. CONCLUSION: TSA reveals insufficient information size and potentially false positive results in many meta......OBJECTIVES: To evaluate meta-analyses with trial sequential analysis (TSA). TSA adjusts for random error risk and provides the required number of participants (information size) in a meta-analysis. Meta-analyses not reaching information size are analyzed with trial sequential monitoring boundaries...... analogous to interim monitoring boundaries in a single trial. STUDY DESIGN AND SETTING: We applied TSA on meta-analyses performed in Cochrane Neonatal reviews. We calculated information sizes and monitoring boundaries with three different anticipated intervention effects of 30% relative risk reduction (TSA...

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

Science.gov (United States)

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

2008-09-01

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

Influence of trial design, heterogeneity and regulatory environment on the results of clinical trials: An appraisal in the context of recent trials on acute stroke intervention

Directory of Open Access Journals (Sweden)

P R Srijithesh

2014-01-01

Full Text Available The outcome of randomized controlled trials can vary depending on the eligibility criteria of the patients entering into the trial, as well as the heterogeneity of the eligible population and/or the interventions. If the subject population and/or interventions are heterogeneous, the final outcome of the trial depends on the degree of concordance of effects of the subgroups of interventions on the subgroups of the subject population. The considerations that go into the calculation of sample size and determination of the study stopping rules also would affect the nature of the outcome of the study. In this paper we try to examine these phenomena with respect to the recent trials on endovascular therapy in acute ischemic stroke.

Field trial of a fast single-pass transmit-receive probe during Gentilly II steam generator tube inspection

International Nuclear Information System (INIS)

Obrutsky, L.; Cantin, M.; Renaud, J.; Cecco, V.; Lakhan, R.; Sullivan, S.

2000-01-01

A new generation of transmit-receive single-pass probes, denoted as C6 or X probe, was field tested during the Gentilly II, 2000 steam generator tube inspection. This probe has a performance equivalent to rotating probes and can be used for tubesheet and full-length inspection at an inspection speed equivalent to that of bobbin probes. Existing C3 transmit-receive probes have been demonstrated to be effective in detecting circumferential cracks. The C5 probe can detect both circumferential and axial cracks and volumetric defects but cannot discriminate between them. The C6 probe expands on the capabilities of both probes in a single probe head. It can simultaneously detect and discriminate between circumferential and axial cracks to satisfy different plugging criteria. It has excellent coverage, good defect detectability, and improved sizing and characterization. Probe data is displayed in C-scan format so that the amount of data to be analyzed is similar to rotating probes. The C6 probe will significantly decrease inspection time and the need for re-inspection and tube pulling. This paper describes the advantages of the probe and demonstrates its capabilities employing signals from tube samples with calibration flaws and laboratory induced cracks. It shows the results from the field trial of the probe at Gentilly II and describes the instrumentation, hardware and software used for the inspection. (author)

Field trial of a fast single-pass transmit-receive probe during Gentilly II steam generator tube inspection

International Nuclear Information System (INIS)

Obrutsky, L.; Cantin, M.; Renaud, J.; Cecco, V.; Lakhan, R.; Sullivan, S.

2000-01-01

A new generation of transmit-receive single-pass probes, denoted as C6 or X probe, was field-tested during the Gentilly II, 2000 steam generator tube inspection. This probe has a performance equivalent to rotating probes and can be used for tubesheet and full-length inspection at an inspection speed equivalent to that of bobbin probes. Existing C3 transmit-receive probes have been demonstrated to be effective in detecting circumferential cracks. The C5 probe can detect both circumferential and axial cracks and volumetric defects but cannot discriminate between them. The C6 probe expands on the capabilities of both probes in a single probe head. It can simultaneously detect and discriminate between circumferential and axial cracks to satisfy different plugging criteria. It has excellent coverage, good defect detectability, and improved sizing and characterization. Probe data is displayed in C-scan format so that the amount of data to be analyzed is similar to rotating probes. The C6 probe will significantly decrease inspection time and the need for re-inspection and tube pulling. This paper describes the advantages of the probe and demonstrates its capabilities employing signals from tube samples with calibration flaws and laboratory induced cracks. It shows the results from the field trial of the probe at Gentilly II and describes the instrumentation, hardware and software used for the inspection. (author)

Return of individual research results and incidental findings in the clinical trials cooperative group setting.

Science.gov (United States)

Ferriere, Michael; Van Ness, Brian

2012-04-01

The National Cancer Institute (NCI)-funded cooperative group cancer clinical trial system develops experimental therapies and often collects samples from patients for correlative research. The cooperative group bank (CGB) system maintains biobanks with a current policy not to return research results to individuals. An online survey was created, and 10 directors of CGBs completed the surveys asking about understanding and attitudes in changing policies to consider return of incidental findings (IFs) and individual research results (IRRs) of health significance. The potential impact of the 10 consensus recommendations of Wolf et al. presented in this issue are examined. Reidentification of samples is often not problematic; however, changes to the current banking and clinical trial systems would require significant effort to fulfill an obligation of recontact of subjects. Additional resources, as well as a national advisory board would be required to standardize implementation.

Learning From Past Failures of Oral Insulin Trials.

Science.gov (United States)

Michels, Aaron W; Gottlieb, Peter A

2018-07-01

Very recently one of the largest type 1 diabetes prevention trials using daily administration of oral insulin or placebo was completed. After 9 years of study enrollment and follow-up, the randomized controlled trial failed to delay the onset of clinical type 1 diabetes, which was the primary end point. The unfortunate outcome follows the previous large-scale trial, the Diabetes Prevention Trial-Type 1 (DPT-1), which again failed to delay diabetes onset with oral insulin or low-dose subcutaneous insulin injections in a randomized controlled trial with relatives at risk for type 1 diabetes. These sobering results raise the important question, "Where does the type 1 diabetes prevention field move next?" In this Perspective, we advocate for a paradigm shift in which smaller mechanistic trials are conducted to define immune mechanisms and potentially identify treatment responders. The stage is set for these interventions in individuals at risk for type 1 diabetes as Type 1 Diabetes TrialNet has identified thousands of relatives with islet autoantibodies and general population screening for type 1 diabetes risk is under way. Mechanistic trials will allow for better trial design and patient selection based upon molecular markers prior to large randomized controlled trials, moving toward a personalized medicine approach for the prevention of type 1 diabetes. © 2018 by the American Diabetes Association.

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

International Nuclear Information System (INIS)

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

2011-01-01

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

Comparison of results from different imputation techniques for missing data from an anti-obesity drug trial

DEFF Research Database (Denmark)

Jørgensen, Anders W.; Lundstrøm, Lars H; Wetterslev, Jørn

2014-01-01

BACKGROUND: In randomised trials of medical interventions, the most reliable analysis follows the intention-to-treat (ITT) principle. However, the ITT analysis requires that missing outcome data have to be imputed. Different imputation techniques may give different results and some may lead to bias...... of handling missing data in a 60-week placebo controlled anti-obesity drug trial on topiramate. METHODS: We compared an analysis of complete cases with datasets where missing body weight measurements had been replaced using three different imputation methods: LOCF, baseline carried forward (BOCF) and MI...

The Effect of Treatment Advances on the Mortality Results of Breast Cancer Screening Trials: A Microsimulation Model.

Science.gov (United States)

Birnbaum, Jeanette; Gadi, Vijayakrishna K; Markowitz, Elan; Etzioni, Ruth

2016-02-16

Mammography trials, which are the primary sources of evidence for screening benefit, were conducted decades ago. Whether advances in systemic therapies have rendered previously observed benefits of screening less significant is unknown. To compare the outcomes of breast cancer screening trials had they been conducted using contemporary systemic treatments with outcomes of trials conducted with previously used treatments. Computer simulation model of 3 virtual screening trials with similar reductions in advanced-stage cancer cases but reflecting treatment patterns in 1975 (prechemotherapy era), 1999, or 2015 (treatment according to receptor status). Meta-analyses of screening and treatment trials; study of dissemination of primary systemic treatments; SEER (Surveillance, Epidemiology, and End Results) registry. U.S. women aged 50 to 74 years. 10 and 25 years. Population. Mammography, chemotherapy, tamoxifen, aromatase inhibitors, and trastuzumab. Breast cancer mortality rate ratio (MRR) and absolute risk reduction (ARR) obtained by the difference in cumulative breast cancer mortality between control and screening groups. At 10 years, screening in a 1975 trial yielded an MRR of 90% and an ARR of 5 deaths per 10,000 women. A 2015 screening trial yielded a 10-year MRR of 90% and an ARR of 3 deaths per 10,000 women. Greater reductions in advanced-stage disease yielded a greater screening effect, but MRRs remained similar across trials. However, ARRs were consistently lower under contemporary treatments. When contemporary treatments were available only for early-stage cases, the MRR was 88%. Disease models simplify reality and cannot capture all breast cancer subtypes. Advances in systemic therapies for breast cancer have not substantively reduced the relative benefits of screening but have likely reduced the absolute benefits because of their positive effect on breast cancer survival. University of Washington and National Cancer Institute.

Predicting plant invasions under climate change: are species distribution models validated by field trials?

Science.gov (United States)

Sheppard, Christine S; Burns, Bruce R; Stanley, Margaret C

2014-09-01

Climate change may facilitate alien species invasion into new areas, particularly for species from warm native ranges introduced into areas currently marginal for temperature. Although conclusions from modelling approaches and experimental studies are generally similar, combining the two approaches has rarely occurred. The aim of this study was to validate species distribution models by conducting field trials in sites of differing suitability as predicted by the models, thus increasing confidence in their ability to assess invasion risk. Three recently naturalized alien plants in New Zealand were used as study species (Archontophoenix cunninghamiana, Psidium guajava and Schefflera actinophylla): they originate from warm native ranges, are woody bird-dispersed species and of concern as potential weeds. Seedlings were grown in six sites across the country, differing both in climate and suitability (as predicted by the species distribution models). Seedling growth and survival were recorded over two summers and one or two winter seasons, and temperature and precipitation were monitored hourly at each site. Additionally, alien seedling performances were compared to those of closely related native species (Rhopalostylis sapida, Lophomyrtus bullata and Schefflera digitata). Furthermore, half of the seedlings were sprayed with pesticide, to investigate whether enemy release may influence performance. The results showed large differences in growth and survival of the alien species among the six sites. In the more suitable sites, performance was frequently higher compared to the native species. Leaf damage from invertebrate herbivory was low for both alien and native seedlings, with little evidence that the alien species should have an advantage over the native species because of enemy release. Correlations between performance in the field and predicted suitability of species distribution models were generally high. The projected increase in minimum temperature and reduced

Application of Radiation Degraded Chitosan as Plant Growth Promoter. A Pilot Scale Production and Field Trial Study of Radiation Processed Chitosan as Plant Growth Promoter for Rice Crops

International Nuclear Information System (INIS)

Dahlan, Khairul Zaman Hj Mohd; Hashim, Kamaruddin; Bahari, Kamarudin

2010-01-01

The application of radiation processed chitosan as plant growth promoter has been carried out in the 24 hectares of rice crops. For the field trial, a pilot scale production of oligochitosan was established using gamma irradiation for partial degradation of chitosan powder of DDA 90% and followed by gamma irradiation of aqueous solution of 3% irradiated chitosan powder in 2% lactic acids (3CL2). Radiation dose of 50 kGy was selected for initial degradation of chitosan powder and followed by 12 kGy irradiation of 3CL2. A viscosity average molecular weight of ~10,000 of oligochitosan was obtained and subsequently used in the field trial of MR219 type of rice seeds on 24 hectares of rice plots. The seedlings were carried out after the rice seeds were soaked 24hrs in water and 30 minutes in 200ppm oligochitosan. The rice plots that were sprayed with oligochitosan were found to have higher resistant towards blast diseases. Oligochitosan of 40ppm was found to be effective as fungicides and resulted in the increase of yield of rice seeds of about 5%. (author)

Resource costing for multinational neurologic clinical trials: methods and results.

Science.gov (United States)

Schulman, K; Burke, J; Drummond, M; Davies, L; Carlsson, P; Gruger, J; Harris, A; Lucioni, C; Gisbert, R; Llana, T; Tom, E; Bloom, B; Willke, R; Glick, H

1998-11-01

We present the results of a multinational resource costing study for a prospective economic evaluation of a new medical technology for treatment of subarachnoid hemorrhage within a clinical trial. The study describes a framework for the collection and analysis of international resource cost data that can contribute to a consistent and accurate intercountry estimation of cost. Of the 15 countries that participated in the clinical trial, we collected cost information in the following seven: Australia, France, Germany, the UK, Italy, Spain, and Sweden. The collection of cost data in these countries was structured through the use of worksheets to provide accurate and efficient cost reporting. We converted total average costs to average variable costs and then aggregated the data to develop study unit costs. When unit costs were unavailable, we developed an index table, based on a market-basket approach, to estimate unit costs. To estimate the cost of a given procedure, the market-basket estimation process required that cost information be available for at least one country. When cost information was unavailable in all countries for a given procedure, we estimated costs using a method based on physician-work and practice-expense resource-based relative value units. Finally, we converted study unit costs to a common currency using purchasing power parity measures. Through this costing exercise we developed a set of unit costs for patient services and per diem hospital services. We conclude by discussing the implications of our costing exercise and suggest guidelines to facilitate more effective multinational costing exercises.

Reporting of noninferiority and equivalence randomized trials for major prostaglandins: A systematic survey of the ophthalmology literature

Directory of Open Access Journals (Sweden)

Rachlis Beth

2008-12-01

Full Text Available Abstract Background Standards for reporting clinical trials have improved the transparency of patient-important research. The Consolidated Standards of Reporting Trials (CONSORT published an extension to address noninferiority and equivalence trials. We aimed to determine the reporting quality of prostaglandin noninferiority and equivalence trials in the treatment of glaucoma. Methods We searched, independently and in duplicate, 6 electronic databases for eligible trials evaluating prostaglandins. We abstracted data on reporting of methodological criteria, including reporting of per-protocol [PP] and intention-to-treat [ITT] analysis, sample size estimation with margins, type of statistical analysis conducted, efficacy summaries, and use of hyperemia measures. Results Trials involving the four major prostaglandin groups (latanoprost, travoprost, bimatoprost, unoprostone were analyzed. We included 36 noninferiority and 11 equivalence trials. Seventeen out of the included 47 trials (36%, 95% Confidence Intervals [CI]: 24–51 were crossover designs. Only 3 studies (6%, 95% CI: 2–17 reported a presented results of both ITT and PP populations. Twelve studies (26%, 95% CI: 15–39 presented only ITT results but mentioned that PP population had similar results. Thirteen trials (28%, 95% CI: 17–42 presented only PP results with no mention of ITT population results while 17 studies (36%, 95% CI: 24–51 presented only ITT results with no mention of PP population results. Thirty-four (72%, 95% CI: 58–83 of studies adequately described their margin of noninferiority/equivalence. Sequence generation was reported in 22/47 trials (47%, 95% CI: 33–61. Allocation concealment was reported in only 10/47 (21%, 95% CI: 12–35 of the trials. Thirty-five studies (74%, 95% CI: 60–85 employed masking of at least two groups, 4/47 (9%, 95% CI: 3–20 masked only patients and 8/47 (17%, 95% CI: 9–30 were open label studies. Eight (17%, 95% CI: 9–30 of the

Eurados trial performance test for photon dosimetry

DEFF Research Database (Denmark)

Stadtmann, H.; Bordy, J.M.; Ambrosi, P.

2001-01-01

Within the framework of the EURADOS Action entitled Harmonisation and Dosimetric Quality Assurance in Individual Monitoring for External Radiation, trial performance tests for whole-body and extremity personal dosemeters were carried out. Photon, beta and neutron dosemeters were considered....... This paper summarises the results of the whole-body photon dosemeter test. Twenty-six dosimetry services from all EU Member States and Switzerland participated. Twelve different radiation fields were used to simulate various workplace irradiation fields. Dose values from 0.4 mSv to 80 mSv were chosen. From...

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

NARCIS (Netherlands)

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

2005-01-01

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

Clinical trials of homoeopathy.

Science.gov (United States)

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

1991-01-01

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

[Economic analysis of multinational clinical trials in oncology].

Science.gov (United States)

Lejeune, Catherine; Lueza, Béranger; Bonastre, Julia

2018-02-01

In oncology, as in other fields of medicine, international multicentre clinical trials came into being so as to include a sufficient number of subjects to investigate a clinical situation. The existence of tight budgetary constraints and the desire to make the best use of the resources available have resulted in the development of economic evaluations associated with these trials, which, thanks to their level of evidence and their size, provide particularly relevant material. Nonetheless, economic evaluations alongside international clinical trials raise specific questions of methodology with regard to both the design and the analysis of the results. Indeed, the costs of goods and services consumed, the types and quantities of resources, and medical practices vary from one country to another and within an individual country. Economic data from the different countries involved must be available so as to study and to take into account this variability, and appropriate techniques for cost estimations and analysis must be implemented to aggregate the results from several countries. From a review of the literature, the aim of this work was to provide an overview of the specific methodological features of economic evaluations alongside international clinical trials: analysis of efficacy data from several countries, collection of resources and real costs, methods to establish the monetary value of resources, methods to aggregate results accounting for the trial effect. Copyright © 2017 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

Approval procedures for clinical trials in the field of radiation oncology; Genehmigungsverfahren klinischer Studien im Bereich der Radioonkologie

Energy Technology Data Exchange (ETDEWEB)

Simon, Monique; Buettner, Daniel [Deutsches Konsortium fuer Translationale Krebsforschung (DKTK), Dresden (Germany); Deutsches Krebsforschungszentrum (DKFZ), Heidelberg (Germany); Medizinische Fakultaet und Universitaetsklinikum Carl Gustav Carus, Technische Universitaet Dresden, Klinik fuer Strahlentherapie und Radioonkologie und OncoRay - Nationales Zentrum fuer Strahlenforschung in der Onkologie, Dresden (Germany); Habeck, Matthias; Habeck, Uta; Brix, Gunnar [Bundesamt fuer Strahlenschutz (BfS), Fachbereich Strahlenschutz und Gesundheit, Neuherberg (Germany); Krause, Mechthild; Baumann, Michael [Deutsches Konsortium fuer Translationale Krebsforschung (DKTK), Dresden (Germany); Deutsches Krebsforschungszentrum (DKFZ), Heidelberg (Germany); Medizinische Fakultaet und Universitaetsklinikum Carl Gustav Carus, Technische Universitaet Dresden, Klinik fuer Strahlentherapie und Radioonkologie und OncoRay - Nationales Zentrum fuer Strahlenforschung in der Onkologie, Dresden (Germany); Helmholtz-Zentrum Dresden - Rossendorf, Institut fuer Radioonkologie und OncoRay - Nationales Zentrum fuer Strahlenforschung in der Onkologie, Dresden (Germany); Willich, Normann [Universitaetsklinikum Muenster, Klinik fuer Strahlentherapie - Radioonkologie, Muenster (Germany); Wenz, Frederik [Universitaetsmedizin Mannheim, Medizinische Fakultaet Mannheim, Universitaet Heidelberg, Klinik fuer Strahlentherapie und Radioonkologie, Mannheim (Germany); Schmidberger, Heinz [Universitaetsmedizin Mainz, Klinik fuer Radioonkologie und Strahlentherapie, Mainz (Germany); Debus, Juergen [Universitaetsklinikum Heidelberg, Klinik fuer Radioonkologie und Strahlentherapie, Heidelberg (Germany); Noelling, Torsten

2015-12-15

Application of ionizing radiation for the purpose of medical research in Germany needs to be approved by the national authority for radiation protection (Bundesamt fuer Strahlenschutz, BfS). For studies in the field of radiation oncology, differentiation between use of radiation for ''medical care (Heilkunde)'' versus ''medical research'' frequently leads to contradictions. The aim of this article is to provide principle investigators, individuals, and institutions involved in the process, as well as institutional review or ethics committees, with the necessary information for this assessment. Information on the legal frame and the approval procedures are also provided. A workshop was co-organized by the German Society for Radiation Oncology (DEGRO), the Working Party for Radiation Oncology (ARO) of the German Cancer Society (DKG), the German Society for Medical Physics (DGMP), and the German Cancer Consortium (DKTK) in October 2013. This paper summarizes the results of the workshop and the follow-up discussions between the organizers and the BfS. Differentiating between ''Heilkunde'' which does not need to be approved by the BfS and ''medical research'' is whether the specific application of radiation (beam quality, dose, schedule, target volume, etc.) is a clinically established and recognized procedure. This must be answered by the qualified physician(s) (''fachkundiger Arzt'' according to German radiation protection law) in charge of the study and the treatments of the patients within the study, taking into consideration of the best available evidence from clinical studies, guidelines and consensus papers. Among the important parameters for assessment are indication, total dose, and fractionation. Radiation treatments applied outside clinical trials do not require approval by the BfS, even if they are applied within a randomized or nonrandomized clinical trial

Field Test: Results of Tandem Walk Performance Following Long-Duration Spaceflight

Science.gov (United States)

Rosenberg, M. J. F.; Reschke, M. F.; Cerisano, J. M.; Kofman, I. S.; Fisher, E. A.; Gadd, N. E.; May-Phillips, T. R.; Lee, S. M. C.; Laurie, S. S.; Stenger, M. B.;

Bioenergy Ecosystem Land-Use Modelling and Field Flux Trial

Science.gov (United States)

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

2013-04-01

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

Missouri Work Zone Capacity : Results of Field Data Analysis

Science.gov (United States)

2011-06-01

This report presents the results of work zone field data analyzed on interstate highways in Missouri to determine : the mean breakdown and queue-discharge flow rates as measures of capacity. Several days of traffic data : collected at a work zone nea...

Competition Between Fusarium pseudograminearum and Cochliobolus sativus Observed in Field and Greenhouse Studies.

Science.gov (United States)

Troth, Erin E Gunnink; Johnston, Jeffrey A; Dyer, Alan T

2018-02-01

Among root pathogens, one of the most documented antagonisms is the suppression of Cochliobolus sativus by Fusarium (roseum) species. Unfortunately, previous studies involved single isolates of each pathogen and thus, provided no indication of the spectrum of responses that occur across the respective species. To investigate the variability in interactions between Cochliobolus sativus and Fusarium pseudograminearum, field and greenhouse trials were conducted that included monitoring of spring wheat plant health and monitoring of pathogen populations via quantitative real-time polymerase chain reaction. The interactions between two isolates of C. sativus and four isolates of F. pseudograminearum were explored in three geographically distinct wheat fields. To complement field trials and to limit potentially confounding environmental variables that are often associated with field studies, greenhouse trials were performed that investigated the interactions among and between three isolates of C. sativus and four isolates of F. pseudograminearum. Across field locations, C. sativus isolate Cs2344 consistently and significantly reduced Fusarium populations by an average of 20.1%. Similarly, F. pseudograminearum isolate Fp2228 consistently and significantly reduced C. sativus field populations by an average of 30.9%. No interaction was detected in the field between pathogen species with regards to disease or crop losses. Greenhouse results confirmed a powerful (>99%), broadly effective suppression of Fusarium populations by isolate Cs2344. Among greenhouse trials, additional isolate-isolate interactions were observed affecting Fusarium populations. Due to lower C. sativus population sizes in greenhouse trials, significant Fusarium suppression of C. sativus was only detected in one isolate-isolate interaction. This study is the first to demonstrate suppression of Fusarium spp. by C. sativus in field and greenhouse settings. These findings also reveal a complex competitive

Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial

OpenAIRE

Rushing, J.; Wing, R.; Wadden, T. A.; Knowler, W. C.; Lawlor, M.; Evans, M.; Killean, T.; Montez, M.; Espeland, M. A.; Zhang, P.

2017-01-01

Summary Objective The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10?years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention. Methods The ...

Renal Denervation: a Field in Flux.

Science.gov (United States)

Laffin, Luke J; Bakris, George L

2016-07-01

SYMPLICITY HTN-3 was a pivotal moment for renal denervation as a treatment option for resistant hypertension. Prior unblinded studies were called into question given the negative results of the first sham-controlled trial of renal denervation. Reevaluation of the renal denervation procedure demonstrated that a more precise approach was needed to adequately denervate the kidney. This new approach has been implemented in two ongoing clinical trials, one on and one off medications to assess the new procedure's efficacy and safety. These and other ongoing trials will be discussed in the context of older studies in this field. We focus on novel findings published following the release of SYMPLICITY HTN-3 data in early 2014 and look to the future of renal denervation in the treatment of primary hypertension.

Test results of BM109 magnet field stability during ramping

International Nuclear Information System (INIS)

Kristalinski, A.

1992-12-01

This report presents results of the measured lag between the current ramp and the following magnetic field rise in BM109 magnets. The purpose of these tests is to choose identical ramping programs for PC4AN1, PC4AN2 and PC4AN3 magnets. The lag occurs due to the large eddy currents in the magnets' solid iron cores. The experiment requires a magnetic field stability of 0.1% during beam presence. Using existing equipment and a program slope of 100 Amp/sec starting at Tl yields fields within the 0.05% of set value. Add to this 0.05% for P.S. regulation to meet the required field stability of 0.1%. This program yields annual savings of $200,000 (assuming 100% usage) . Additional savings can be made by using faster slopes, but this requires additional controls

Investigators' viewpoint of clinical trials in India: Past, present and future

Directory of Open Access Journals (Sweden)

Mohandas K Mallath

2017-01-01

Full Text Available India's success in producing food and milk for its population (Green Revolution and White Revolution happened because of scientific research and field trials. Likewise improving the health of Indians needs clinical research and clinical trials. A Large proportion of the sick Indians are poor, illiterate with no access to good health care. They are highly vulnerable to inducement and exploitation in clinical trials. The past two decades saw the rise and fall of clinical trials in India. The rise happened when our regulators created a favorable environment, and Indian investigators were invited to participate in global clinical trials. The gap between the demand and supply resulted in inadequate protection of the trial participants. Reports of abuses of the vulnerable trial participants followed by public interest litigations led to strengthening of regulations by the regulators. The stringent new regulations made the conduct of clinical trials more laborious and increased the cost of clinical trials in India. There was a loss of interest in sponsored clinical trials resulting in the fall in global clinical trials in India. Following repeated appeals by the investigators, the Indian regulators have recently relaxed some of the stringent regulations, while continuing to ensure the adequate patient protection. Clinical trials that are relevant to our population and conducted by well-trained investigators and monitored by trained and registered Ethics Committees will increase in the future. We must remain vigilant, avoid previous mistakes, and strive hard to protect the trial participants in the future trials.

Contemporary Aspects of Marketing in Clinical Trials Including Segments of IT and Technology Transfer

Science.gov (United States)

Stamenovic, Milorad; Dobraca, Amra; Smajlovic, Mersiha

2018-01-01

Introduction: The aim of this paper is to present the marketing strategy and the application of management (marketing management) and advertising in order to increase the efficiency of innovative approach in clinical trials that include and involve the use of new technologies and transfer of technologies. Material and Methods: This paper has a descriptive character and represents a narrative review of the literature and new model implementation. Results: Marketing models are primarily used to improve the inclusion of a larger (and appropriate) number of patients, but they can be credited for the stay and monitoring of patients in the trial. Regulatory mechanisms play an important role in the application of various marketing strategies within clinical trials. The value for the patient as the most important stakeholder is defined in the field of clinical trials according to Kotler’s value model for the consumer. Conclusion: In order to achieve the best results it is important to adequately examine all the elements of clinical trials and apply this knowledge in creation of a marketing plan that will be made in accordance with the legal regulations defined globally and locally. In this paper, two challenges have been highlighted for the adequate application of marketing tools in the field of clinical trials, namely: defining business elements in order to provide an adequate marketing approach for clinical trials and technology transfer and ensuring uniformity and regulatory affirmation of marketing attitudes in clinical trials in all regions in which they are carried out in accordance with ICH-GCP and valid regulations. PMID:29719318

Plastic straws for frozen semen. (A field evaluation).

Science.gov (United States)

Macpherson, J W; King, G J

1966-04-01

A field trial was conducted to compare the routine frozen semen methods presently used at this laboratory with those reported by French workers. When the extender used was sterile milk both methods resulted in fertility equal to the standard. Fertility results obtained with the French method employing Lactiphos extender were significantly lower than the standard.

Twenty-seven years of phase III trials for patients with extensive disease small-cell lung cancer: disappointing results.

Directory of Open Access Journals (Sweden)

Isao Oze

Full Text Available BACKGROUND: Few studies have formally assessed whether treatment outcomes have improved substantially over the years for patients with extensive disease small-cell lung cancer (ED-SCLC enrolled in phase III trials. The objective of the current investigation was to determine the time trends in outcomes for the patients in those trials. METHODS AND FINDINGS: We searched for trials that were reported between January 1981 and August 2008. Phase III randomized controlled trials were eligible if they compared first-line, systemic chemotherapy for ED-SCLC. Data were evaluated by using a linear regression analysis. RESULTS: In total, 52 trials were identified that had been initiated between 1980 and 2006; these studies involved 10,262 patients with 110 chemotherapy arms. The number of randomized patients and the proportion of patients with good performance status (PS increased over time. Cisplatin-based regimens, especially cisplatin and etoposide (PE regimen, have increasingly been studied, whereas cyclophosphamide, doxorubicin, and vincristine-based regimens have been less investigated. Multiple regression analysis showed no significant improvement in survival over the years. Additionally, the use of a PE regimen did not affect survival, whereas the proportion of patients with good PS and the trial design of assigning prophylactic cranial irradiation were significantly associated with favorable outcome. CONCLUSIONS AND SIGNIFICANCE: The survival of patients with ED-SCLC enrolled in phase III trials did not improve significantly over the years, suggesting the need for further development of novel targets, newer agents, and comprehensive patient care.

Adaptive genetic variability and differentiation of Croatian and Austrian Quercus robur L. populations at a drought prone field trial

Directory of Open Access Journals (Sweden)

Saša Bogdan

2017-07-01

Full Text Available Provenance trials, where populations of different geographical origin are tested in a common environment (common garden test, are a tool suited to allow the study of intraspecific adaptive genetic variation. Research of pedunculate oak (Quercus robur L. adaptive genetic variability through analyses of populations in common garden tests has a long tradition. However, pedunculated oak populations originating south-eastern from the Alps have been scarcely studied in this way. This study addresses the adaptive genetic variability and differentiation of pedunculate oak populations originating from Austria and Croatia in a provenance/progeny field trial. Studied plants were six years old and were growing at the trial for three years. After two years of unusually low precipitations height and survival were analysed. The total mean height of all plants in the trial was 137.8 cm and ranged from 123.0 cm to 151.8 cm. The overall mean survival rate was rather high (0.85. Mean population survival ranged from 0.64 to 0.94. Individual narrow-sense heritabilities (hi2, family mean heritabilities (hf2, the coefficients of additive genetic variation (CVA and quantitative genetic differentiation coefficients (QST were calculated. A multivariate regression tree (MRT analysis was used to determine the pattern of genetic differentiation of the populations. Individual heritabilities for height ranged between 0.00 and 0.39. Family mean heritabilities for height were rather low in most populations as well (<0.5. Family mean heritabilities for survival were higher than for height (ranging between 0.00 and 0.77. Calculated QST coefficients (0.25 for height and 0.14 for survival indicated between-population genetic differentiation. The populations were separated into two clusters by MRT analysis regarding a climatic variable, namely Hargreaves’ reference evapotranspiration. Populations originating from comparatively more humid habitats were grouped in the first

Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.

Science.gov (United States)

da Cruz, Lyndon; Dorn, Jessy D; Humayun, Mark S; Dagnelie, Gislin; Handa, James; Barale, Pierre-Olivier; Sahel, José-Alain; Stanga, Paulo E; Hafezi, Farhad; Safran, Avinoam B; Salzmann, Joel; Santos, Arturo; Birch, David; Spencer, Rand; Cideciyan, Artur V; de Juan, Eugene; Duncan, Jacque L; Eliott, Dean; Fawzi, Amani; Olmos de Koo, Lisa C; Ho, Allen C; Brown, Gary; Haller, Julia; Regillo, Carl; Del Priore, Lucian V; Arditi, Aries; Greenberg, Robert J

2016-10-01

The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP. Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II. Thirty participants in 10 centers in the United States and Europe. The worse-seeing eye of blind patients was implanted with the Argus II. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Secondary measures included functional vision performance on objectively scored real-world tasks. Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks. The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Chemical and microbiological water quality of subsurface agricultural drains during a field trial of liquid dairy manure effluent application rate and varying tillage practices, Upper Tiffin Watershed, southeastern Michigan

Science.gov (United States)

Haack, Sheridan Kidd; Duris, Joseph W.

2008-01-01

-water-quality single-sample criterion of 235 colony forming units per 100 milliliters in only 3 of 56 samples. Of these three samples, two were collected within 1 day post-LDME application from the treatment receiving 8,000 gal/acre LDME with no tillage (NT8000). The third sample was from the rolling-tine aerator treatment with 4,000 gal/acre LDME application rate after the first significant rainfall. Two wastewater chemicals and two bacterial genes (eaeA and stx1) detected in the LDME, but absent in field blank or pre-application samples, were detected in the 4-hour or 1-day postapplication NT8000 samples. No LDME-associated chemicals were detected in later samples from the NT8000 treatment, and none were detected in samples from other treatments after the first significant rainfall. Results of this field trial were somewhat equivocal with respect to the influence of LDME concentration and tillage practices on subsurface-drain water quality, both immediately after LDME application and in the longer term, after significant rainfall. Interpretation of study findings is limited by the fact that treatments were not replicated, and flow rate or discharge from the subsurface drains was not measured. Nevertheless, study results provide useful information about nutrient and bacteria concentrations in subsurface drains during the non-growing season. In addition, study results demonstrate some potential for the use of chemical and microbiological indicators of LDME transport to subsurface drains.

Yield and economic performance of organic and conventional cotton-based farming systems--results from a field trial in India.

Science.gov (United States)

Forster, Dionys; Andres, Christian; Verma, Rajeev; Zundel, Christine; Messmer, Monika M; Mäder, Paul

2013-01-01

The debate on the relative benefits of conventional and organic farming systems has in recent time gained significant interest. So far, global agricultural development has focused on increased productivity rather than on a holistic natural resource management for food security. Thus, developing more sustainable farming practices on a large scale is of utmost importance. However, information concerning the performance of farming systems under organic and conventional management in tropical and subtropical regions is scarce. This study presents agronomic and economic data from the conversion phase (2007-2010) of a farming systems comparison trial on a Vertisol soil in Madhya Pradesh, central India. A cotton-soybean-wheat crop rotation under biodynamic, organic and conventional (with and without Bt cotton) management was investigated. We observed a significant yield gap between organic and conventional farming systems in the 1(st) crop cycle (cycle 1: 2007-2008) for cotton (-29%) and wheat (-27%), whereas in the 2(nd) crop cycle (cycle 2: 2009-2010) cotton and wheat yields were similar in all farming systems due to lower yields in the conventional systems. In contrast, organic soybean (a nitrogen fixing leguminous plant) yields were marginally lower than conventional yields (-1% in cycle 1, -11% in cycle 2). Averaged across all crops, conventional farming systems achieved significantly higher gross margins in cycle 1 (+29%), whereas in cycle 2 gross margins in organic farming systems were significantly higher (+25%) due to lower variable production costs but similar yields. Soybean gross margin was significantly higher in the organic system (+11%) across the four harvest years compared to the conventional systems. Our results suggest that organic soybean production is a viable option for smallholder farmers under the prevailing semi-arid conditions in India. Future research needs to elucidate the long-term productivity and profitability, particularly of cotton and

Assessment of blinding success among dental implant clinical trials: A systematic review

Directory of Open Access Journals (Sweden)

Jafar Kolahi

2015-01-01

Full Text Available Introduction: It is widely believed that blinding is a cornerstone of randomized clinical trials and that significant bias may result from unsuccessful blinding. However, it is not enough to claim that a clinical trial is single- or double-blinded and that assessment of the success of blinding is ideal. The aim of this study was to evaluate the prevalence of assessment of blinding success among dental implant clinical trials and to introduce methods of blinding assessment to the implant research community. Methods: In November 2014, PubMed was searched by blinded and experienced researchers with the query "implant AND (blindFNx01 OR maskFNx01" using the following filters: (1 Article type: clinical trial; (2 Journal categories: dental journals; (3 Field: title/abstract. Consequently, title/abstract was reviewed in all relevant articles to find any attempt to assess the success of blinding in dental implant clinical trials. Results: The PubMed search results yielded 86 clinical trials. The point of interest is that when "blindFNx01 OR maskFNx01" was deleted from the query, the number of results increased to 1688 clinical trials. This shows that only 5% of dental implant clinical trials tried to use blinding. Disappointingly, we could not find any dental implant clinical trial reporting any attempt to assess the success of blinding. Conclusion: The current status of turning a blind eye to unblinding in dental implant clinical trials is not tolerable and needs to be improved. Researchers, protocol reviewers, local ethical committees, journal reviewers, and editors should make a concerted effort to incorporate, report, and publish such information to understand its potential impact on study results.

Bright Light for Weight Loss: Results of a Controlled Crossover Trial

Directory of Open Access Journals (Sweden)

Konstantin V. Danilenko

2013-02-01

Full Text Available Objective: To investigate whether bright light treatment can reduce body mass in overweight subjects irrespective of their seasonal (= light dependence. Methods: A crossover, placebo-controlled, randomized clinical trial was performed between November and April in Novosibirsk, Russia (55° N. The trial comprised a 3-week in-home session of morning bright light treatment using a device of light-emitting diodes and a 3-week placebo session by means of a deactivated ion generator, separated by an off-protocol period of at least 23 days. The number of placebo and light sessions was matched with respect to season. Data were obtained from 34 overweight women, aged 20-54 years, 10 were seasonal-dependent according to the Seasonal Pattern Assessment Questionnaire. Weekly measures included body weight, percentage body fat by bioimpedancemetry, and subjective scores (appetite, mood, energy levels. Results: Motivation and expectation towards weight loss were similar for the two intervention sessions. With light, compared to the placebo session, weight did not reduce significantly, but percentage fat, fat mass, and appetite were significantly lower (average fat reduction 0.35 kg. The latter two results remained significant after excluding seasonal-dependent subjects from the analysis. Irrespective of the type of intervention, seasonal-dependent subjects had greater weight and fat mass changes during treatment (decline p 0.036 or between sessions (regain p 0.003. Photoperiod (p = 0.0041, air temperature to a lesser extent (p = 0.012, but not sunshine (p = 0.29 was associated with the weight change (greater weight reduction if the second session was in spring. Conclusion: Morning bright light treatment reduces body fat and appetite in overweight women and may be included in weight control programs.

Type 2 diabetes prevention in the "real world": one-year results of the GOAL Implementation Trial.

Science.gov (United States)

Absetz, Pilvikki; Valve, Raisa; Oldenburg, Brian; Heinonen, Heikki; Nissinen, Aulikki; Fogelholm, Mikael; Ilvesmäki, Vesa; Talja, Martti; Uutela, Antti

2007-10-01

"Real-world" implementation of lifestyle interventions is a challenge. The Good Ageing in Lahti Region (GOAL) Lifestyle Implementation Trial was designed for the primary health care setting, with lifestyle and risk reduction objectives derived from the major diabetes prevention efficacy trials. We report on the program's effectiveness as well as findings related to the program's reach, adoption, and implementation. A total of 352 middle-aged participants with elevated type 2 diabetes risk were recruited from the health care centers in Päijät-Häme Province in Finland. The intervention included six group counseling sessions, delivered by trained public health nurses. Measurement was conducted at baseline and 12 months. Clinical risk factors were measured by study nurses, and lifestyle outcomes were analyzed from self-reports. Lifestyle outcomes were compared with the outcomes achieved in relevant efficacy trials, and within-subject changes were tested for risk reduction. At baseline, mean BMI was >32 kg/m2, and 25% of the participants had impaired glucose tolerance. At 12 months, 20% of participants achieved at least four of five key lifestyle outcomes, with these results being comparable with the reference trials. However, physical activity and weight loss goals were achieved significantly less frequently (65 vs. 86% and 12 vs. 43%, respectively). Several clinical risk factors decreased, more so among men than women. This trial demonstrates that lifestyle counseling can be effective and is feasible in real-world settings for individuals with elevated risk of type 2 diabetes. To increase program impact, program exposure and treatment intensity need to be increased.

Effects of a single inhalative exposure to formaldehyde on the open field behavior of mice.

Science.gov (United States)

Malek, Fathi A; Möritz, Klaus-Uwe; Fanghänel, Jochen

2004-02-01

The effects of formaldehyde on the explorative behavior and locomotor activity of mice after a single inhalative exposure were examined in an open field. Adult male mice were exposed to approximately 1.1 ppm, 2.3 ppm, or 5.2 ppm formaldehyde vapour for 2 hours and the open field test was carried out two hours after the end of exposure (trial 1) and repeated 24 hours thereafter (trial 2). The following behavioral parameters were quantitatively examined: numbers of crossed floor squares (inner, peripheral, total), sniffing, grooming, rearing, climbing, and incidence of fecal boli. The results of the first trial revealed that the motion activity was significantly reduced in all exposed groups. In the 1.1 ppm group, the frequency of rearing was reduced and that of floor sniffing increased. The exposure to the two higher formaldehyde concentrations caused a significant decrease in total numbers of floor squares crossed by the subjects, air sniffing, and rearing. The open field test on the next day (trial 2) showed that the frequencies of floor sniffing, grooming, and rearing in all formaldehyde groups were significantly altered. In the 2.5 ppm group, an increased incidence of fecal boli was observed. From the results obtained, we conclude that the exposure of male mice to formaldehyde vapour affects their locomotor and explorative activity in the open field, and that some open field parameters are still altered in the exposed animals even after 24 hours.

Study on the system development for evaluating long-term alteration of hydraulic field in Near Field 2

International Nuclear Information System (INIS)

Okutu, Kazuo; Morikawa, Seiji; Takamura, Hisashi

2003-02-01

For the high performance evaluation of reliability of TRU waste repository, the system development for evaluating long-term alteration in consideration of the changes action of barrier materials of hydraulic field in Near Field is required. In this research, the system development for evaluating long-term alteration of hydraulic field in Near Field was examined. The model evaluating each phenomena and the prototype system for chemical/mechanical analysis system were developed, and the method of coupling chemical with dynamic analysis was examined. To improve accuracy and propriety of this analysis system in the future, necessary development elements were arranged. The research result of this year is shown below. 1) Knowledge concerning the chemical phenomena in the near field evolution was rearranged. Experimental approaches and analysis methods were applied to the phenomena of which the knowledge can be obtained. Approaches to focus the model were applied to the phenomena for which knowledge is essentially difficult to obtain. The analysis model was improved using knowledge from natural analog and computational analyses. An analysis system was developed and the propriety of the model was demonstrated. 2) The model of bentonite material was developed by focusing attention on nonlinear swelling behavior. And the model of cement material was developed by focusing attention on deformation behavior influenced by leaching of calcium element which cause reducing of rigidity and strength. With regard to the bentonite model, to testify its propriety, the trial analysis result compared with the consolidation properties test data. Furthermore, the dynamic alteration action analysis system consisted of bentonite and cement model was developed, and trial analysis was performed. In this trial analysis, parameters of cation exchange ratio of Na-bentonite for Ca ion and leaching ratio of Ca from cement material were considered. On the one hand, as concerns rock, to include the

MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results.

Science.gov (United States)

Staats, Peter S; Benyamin, Ramsin M

2016-02-01

Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Prospective, multi-center, randomized controlled clinical trial. Twenty-six US interventional pain management centers. To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each

Recent Research Results in the Field of Electric Drives and Mechatronics

Directory of Open Access Journals (Sweden)

Jan Vittek

2003-01-01

Full Text Available The paper presents an overview of research results achieved in the field of Electrical Drives and Mechatronics for the period of three years. The achieved outputs are formed into three individual parts. In the field of Electric Drives the most significant outputs have been achieved in the development of a new control algorithms for a.c. drives under general name 'Forced Dynamics Control' , in improvement of shaft sensorless control methods and in implementation of developed algorithms via digital signal processors. In the field of Electric Traction the most important results have been gained in optimization of power of traction vehicles andat development of diagnostic systems for evaluation of technical conditions of traction devices. In the field of Electric Machines the most important outputs have been achieved in the research of modern electronically commutated electrical machines, their performances in steady and transient states, new design method for their configuration and new methods for automatic parameters identification. In the end the list of the most important publications for all three parts is enclosed.

Clinical Trials

Medline Plus

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. ...

Survival after relapse in patients with endometrial cancer : results from a randomized trial

NARCIS (Netherlands)

Creutzberg, CL; van Putten, WLJ; Koper, PC; Lybeert, MLM; Jobsen, JJ; Warlam-Rodenhuis, CC; De Winter, KAJ; Lutgens, LCHW; van den Bergh, ACM; van der Steen-Banasik, E; Beerman, H; van Lent, M

Objective. The aim of this study was to determine the rates of local control and survival after relapse in patients with stage I endometrial cancer treated in the multicenter randomized PORTEC trial. Methods, The PORTEC trial included 715 patients with stage I endometrial cancer, either grade I or 2

Does transfusion improve the outcome for HNSCC patients treated with radiotherapy? - Results from the randomized DAHANCA 5 and 7 trials

DEFF Research Database (Denmark)

Hoff, Camilla Molich; Lassen, Pernille; Eriksen, Jesper Grau

2011-01-01

of transfusion by the results from the randomized DAHANCA 5 trial, including 414 patients in the analysis. Aim of the current analysis was to gain additional power by adding patients from the continued subrandomization in the DAHANCA 7 trial, now including a total of almost 1200 patients. Material and methods...

Adaptive radiotherapy for head and neck cancer—Dosimetric results from a prospective clinical trial

International Nuclear Information System (INIS)

Schwartz, David L.; Garden, Adam S.; Shah, Shalin J.; Chronowski, Gregory; Sejpal, Samir; Rosenthal, David I.; Chen, Yipei; Zhang, Yongbin; Zhang, Lifei; Wong, Pei-Fong; Garcia, John A.; Kian Ang, K.; Dong, Lei

2013-01-01

Purpose: To conduct a clinical trial evaluating adaptive head and neck radiotherapy (ART). Methods: Patients with locally advanced oropharyngeal cancer were prospectively enrolled. Daily CT-guided setup and deformable image registration permitted mapping of dose to avoidance structures and CTVs. We compared four planning scenarios: (1) original IMRT plan aligned daily to marked isocenter (BB); (2) original plan aligned daily to bone (IGRT); (3) IGRT with one adaptive replan (ART1); and (4) actual treatment received by each study patient (IGRT with one or two adaptive replans, ART2). Results: All 22 study patients underwent one replan (ART1); eight patients had two replans (ART2). ART1 reduced mean dose to contralateral parotid by 0.6 Gy or 2.8% (paired t-test; p = 0.003) and ipsilateral parotid by 1.3 Gy (3.9%) (p = 0.002) over the IGRT alone. ART2 further reduced the mean contralateral parotid dose by 0.8 Gy or 3.8% (p = 0.026) and ipsilateral parotid by 4.1 Gy or 9% (p = 0.001). ART significantly reduced integral body dose. Conclusions: This pilot trial suggests that head and neck ART dosimetrically outperforms IMRT. IGRT that leverages conventional PTV margins does not improve dosimetry. One properly timed replan delivers the majority of achievable dosimetric improvement. The clinical impact of ART must be confirmed by future trials

Water Column Exploration Field Trial I (EX0904, EM302) aboard the NOAA Ship Okeanos Explorer in the Gorda Ridge, off the coasts of Oregon and California

Data.gov (United States)

National Oceanic and Atmospheric Administration, Department of Commerce — This cruise is a water column exploration field trial cruise, designed to test and refine operations for conducting water column exploration using NOAA Ship Okeanos...

Randomized controlled trials of HIV/AIDS prevention and treatment in Africa: results from the Cochrane HIV/AIDS Specialized Register.

Directory of Open Access Journals (Sweden)

Babalwa Zani

Full Text Available INTRODUCTION: To effectively address HIV/AIDS in Africa, evidence on preventing new infections and providing effective treatment is needed. Ideally, decisions on which interventions are effective should be based on evidence from randomized controlled trials (RCTs. Our previous research described African RCTs of HIV/AIDS reported between 1987 and 2003. This study updates that analysis with RCTs published between 2004 and 2008. OBJECTIVES: To describe RCTs of HIV/AIDS conducted in Africa and reported between 2004 and 2008. METHODS: We searched the Cochrane HIV/AIDS Specialized Register in September 2009. Two researchers independently evaluated studies for inclusion and extracted data using standardized forms. Details included location of trials, interventions, methodological quality, location of principal investigators and funders. RESULTS: Our search identified 834 RCTs, with 68 conducted in Africa. Forty-three assessed prevention-interventions and 25 treatment-interventions. Fifteen of the 43 prevention RCTs focused on preventing mother-to-child HIV transmission. Thirteen of the 25 treatment trials focused on opportunistic infections. Trials were conducted in 16 countries with most in South Africa (20, Zambia (12 and Zimbabwe (9. The median sample size was 628 (range 33-9645. Methods used for the generation of the allocation sequence and allocation concealment were adequate in 38 and 32 trials, respectively, and 58 reports included a CONSORT recommended flow diagram. Twenty-nine principal investigators resided in the United States of America (USA and 18 were from African countries. Trials were co-funded by different agencies with most of the funding obtained from USA governmental and non-governmental agencies. Nineteen pharmaceutical companies provided partial funding to 15 RCTs and African agencies co-funded 17 RCTs. Ethical approval was reported in 65 trials and informed consent in 61 trials. CONCLUSION: Prevention trials dominate the trial

Competitive Employment for Youth with Autism Spectrum Disorders: Early Results from a Randomized Clinical Trial

Science.gov (United States)

Wehman, Paul H.; Schall, Carol M.; McDonough, Jennifer; Kregel, John; Brooke, Valerie; Molinelli, Alissa; Ham, Whitney; Graham, Carolyn W.; Riehle, J. Erin; Collins, Holly T.; Thiss, Weston

2014-01-01

For most youth with autism spectrum disorders (ASD), employment upon graduation from high school or college is elusive. Employment rates are reported in many studies to be very low despite many years of intensive special education services. This paper presented the preliminary results of a randomized clinical trial of Project SEARCH plus ASD…

Power analysis of trials with multilevel data

CERN Document Server

Moerbeek, Mirjam

2015-01-01

Power Analysis of Trials with Multilevel Data covers using power and sample size calculations to design trials that involve nested data structures. The book gives a thorough overview of power analysis that details terminology and notation, outlines key concepts of statistical power and power analysis, and explains why they are necessary in trial design. It guides you in performing power calculations with hierarchical data, which enables more effective trial design.The authors are leading experts in the field who recognize that power analysis has attracted attention from applied statisticians i

The impact of radiologists' expertise on screen results decisions in a CT lung cancer screening trial

International Nuclear Information System (INIS)

Heuvelmans, Marjolein A.; Vliegenthart, Rozemarijn; Oudkerk, Matthijs; Jong, Pim A. de; Mali, Willem P.; Groen, Harry J.M.

2015-01-01

To evaluate the impact of radiological expertise on screen result decisions in a CT lung cancer screening trial. In the NELSON lung cancer screening trial, the baseline CT result was based on the largest lung nodule's volume. The protocol allowed radiologists to manually adjust screen results in cases of high suspicion of benign or malignant nodule nature. Participants whose baseline CT result was based on a solid or part-solid nodule were included in this study. Adjustments by radiologists at baseline were evaluated. Histology was the reference for diagnosis or to confirm benignity and stability on subsequent CT examinations. A total of 3,318 participants (2,796 male, median age 58.0 years) were included. In 195 participants (5.9 %) the initial baseline screen result was adjusted by the radiologist. Adjustment was downwards from positive or indeterminate to negative in two and 119 participants, respectively, and from positive to indeterminate in 65 participants. None of these nodules turned out to be malignant. In 9/195 participants (4.6 %) the screen result was adjusted upwards from negative to indeterminate or indeterminate to positive; two nodules were malignant. In one in 20 cases of baseline lung cancer screening, nodules were reclassified by the radiologist, leading to a reduction of false-positive screen results. (orig.)

Results of ITER toroidal field coil cover plate welding test

International Nuclear Information System (INIS)

Koizumi, Norikiyo; Matsui, Kunihiro; Shimizu, Tatsuya; Nakajima, Hideo; Iijima, Ami; Makino, Yoshinobu

2012-01-01

In ITER Toroidal Field (TF) coils, cover plates (CP) are welded to the teeth of the radial plate (RP) to fix conductors in the grooves of the RP. Though the total length of the welds is approximately 1.5 km and the height and width of the RP are 14 and 9 m, respectively, welding deformation of smaller than 1 mm for local out-of-plane distortion and smaller than several millimeters for in-plane deformation is required. Therefore, laser welding is used for CP welding to reduce welding deformation as much as possible. However, the gap in welding joints is expected to be a maximum of 0.5 mm. Thus, a laser welding technique to enable welding of joints with a gap of 0.5 mm in width has been developed. Applying this technology, a CP welding trial using an RP mock-up was successfully performed. The achieved local flatness, that is, the flatness of the cross-section of the RP mock-up, is 0.6 mm. The analysis using inherent strains, which are derived from the welding test using flat plates, also indicates that better local flatness can be achieved if the initial distortion is zero. In addition, the welding deformation of a full-scale RP is evaluated via analysis using the inherent strain. The analytical results show that in-plane deformation is approximately 5 mm and large out-of-plane deformation, consisting of approximately 5 mm-long wave distortion and a twist of approximately 1.5 mm in the RP cross-section, is generated. It is expected that the required profile can be achieved by determining the original geometry of an RP by simulating deformation during welding. It is also expected that the required local flatness of a DP can be achieved, since out-of-plane deformation can be reduced by increasing the number of RPs turned over during CP welding. A more detailed study is required. (author)

Evaluating the financial impact of clinical trials in oncology: results from a pilot study from the Association of American Cancer Institutes/Northwestern University clinical trials costs and charges project.

Science.gov (United States)

Bennett, C L; Stinson, T J; Vogel, V; Robertson, L; Leedy, D; O'Brien, P; Hobbs, J; Sutton, T; Ruckdeschel, J C; Chirikos, T N; Weiner, R S; Ramsey, M M; Wicha, M S

2000-08-01

Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials. Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer. The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P =.4) Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning

Research and field trials with a blend of ethanol in diesel oil

Energy Technology Data Exchange (ETDEWEB)

Egebaeck, K.E. [Autoemission K-E E Consultant, Nykoeping (Sweden)

1999-03-01

The aim of this report is to summarize the experiences acquired and data generated during the project named `The mixed fuel project` which was carried out during the years 1993 to 1997. The project was initiated after that some information had been collected in Australia, where a similar project was underway. The Australian project showed some interesting data and within that project an emulsifier had been developed - an emulsifier which has also been used in the Swedish project. In order to avoid a costly development of a method for blending ethanol in diesel oil, a form of co-operation was established between the people involved in Australia and those involved in Sweden. The content of ethanol in diesel oil used in Australia was 15 % and the investigations in Sweden reported further down in this report the ratio 15 % ethanol in MK 1 (an environmentally classified diesel fuel in Sweden) was the best alternative to be used also in Sweden. Twelve reports have been studied and used as references in order to summarize the results and experiences from the project. In order to fulfil the obligations of the project many institutions, private and community companies, consultants and universities in Sweden were involved. In the report presents the main results from the different investigations and field trials with ethanol-diesel fueled vehicles. It can be said that there are no technical problems connected to the use of ethanol-diesel fuel but the most serious drawback is the cost of the fuel. There is also a need for further development of the technology of making a homogenous emulsion of ethanol in diesel oil at a reasonable cost. The main advantage of using the mixed fuel is that the emission of particles is considerably reduced. The emission of CO{sub 2} is also reduced when the ethanol is produced from biomass using an environmentally friendly method 17 refs, 22 figs, 22 tabs

Effects of prenatal X-irradiation on open-field behavior in rats: application of randomized fostering technique and mapping results

International Nuclear Information System (INIS)

Tachibana, T.

1986-01-01

Sprague-Dawley (SD) rats were given X-irradiation (150 R) on Day 17 of gestation. After birth, all male pups were pooled once and then assigned randomly to irradiated mothers and control mothers. Offspring were administered an open-field test at about 7 weeks of age. The analysis was performed on the basis of two approaches: In the per subject approach, individual subject data (aggregation across Day 2 through Day 4) were treated as the basic unit of statistical analysis. In the per litter approach, double aggregation (aggregation across Day 2 through Day 4 for each subject and aggregation across subjects within each litter) was used. The per subject approach was slightly more sensitive as to the treatment effect, but it induced a reduction in the magnitude of eta squared. A principal component analysis was performed using eta squared together with those of several reference groups. Results were plotted on a map constructed from component scores. The characteristics of behavior in X-irradiated rats were very similar to those of the earlier stage of trials in terms of the location on the map. The postnatal maternal effect on open-field behavior was not serious and was adequately negligible in practice. A new fostering procedure was proposed and its advantages discussed

Field reversal experiments: FRX-A and FRX-B results

International Nuclear Information System (INIS)

Armstrong, W.T.; Linford, R.K.; Lipson, J.; Platts, D.A.; Sherwood, E.G.

1981-01-01

The equilibrium, stability, and confinement properties of the Field Reversed Configuration (FRC) are being studied in two theta pinch facilities referred to as FRX-A, and FRX-B. The configuration is a toroidal plasma confined in a purely poloidal field configuration containing both closed and open field lines. The FRX system produces highly elongated tori with major radius R=3 to 5 cm, minor radius a approx. 2 cm, and a full length l approx. 35 to 50 cm. Plasma conditions have ranged from T/sub e/ approx. 150 eV, T/sub i/ approx. 800 eV, and n/sub max/ approx. 10 15 /cm 3 to T/sub e/ approx. 100 eV, T/sub i/ approx. 150 eV, and n/sub max/ approx. 4 x 10 15 /cm 3 . The plasma remains in a stable equilibrium for up to 50 μs followed by an n = 2 rotational instability which results in termination of the FRC. The plasma behavior with respect to equilibrium, stability, and rotation is consistent with recent theoretical work in these areas

Changes of attachment characteristics during psychotherapy of patients with social anxiety disorder: Results from the SOPHO-Net trial.

Science.gov (United States)

Strauß, Bernhard; Altmann, Uwe; Manes, Susanne; Tholl, Anne; Koranyi, Susan; Nolte, Tobias; Beutel, Manfred E; Wiltink, Jörg; Herpertz, Stephan; Hiller, Wolfgang; Hoyer, Jürgen; Joraschky, Peter; Nolting, Björn; Ritter, Viktoria; Stangier, Ulrich; Willutzki, Ulrike; Salzer, Simone; Leibing, Eric; Leichsenring, Falk; Kirchmann, Helmut

2018-01-01

Within a randomized controlled trial contrasting the outcome of manualized cognitive-behavioral (CBT) and short term psychodynamic therapy (PDT) compared to a waiting list condition (the SOPHO-Net trial), we set out to test whether self-reported attachment characteristics change during the treatments and if these changes differ between treatments. 495 patients from the SOPHO-Net trial (54.5% female, mean age 35.2 years) who were randomized to either CBT, PDT or waiting list (WL) completed the partner-related revised Experiences in Close Relationships Questionnaire (ECR-R) before and after treatment and at 6 and 12 months follow-up. The Liebowitz Social Anxiety Scale (LSAS) was administered at pre-treatment, post-treatment, and at 6-month and 1-year follow-up. ECR-R scores were first compared to a representative healthy sample (n = 2508) in order to demonstrate that the clinical sample differed significantly from the non-clinical sample with respect to attachment anxiety and avoidance. LSAS scores correlated significantly with both ECR-R subscales. Post-therapy, patients treated with CBT revealed significant changes in attachment anxiety and avoidance whereas patients treated with PDT showed no significant changes. Changes between post-treatment and the two follow-ups were significant in both conditions, with minimal (insignificant) differences between treatments at the 12- month follow-up. The current study supports recent reviews of mostly naturalistic studies indicating changes in attachment as a result of psychotherapy. Although there were differences between conditions at the end of treatment, these largely disappeared during the follow-up period which is line with the other results of the SOPHO-NET trial. Controlled-trials.com ISRCTN53517394.

A randomized phase II dose-response exercise trial among colon cancer survivors: Purpose, study design, methods, and recruitment results.

Science.gov (United States)

Brown, Justin C; Troxel, Andrea B; Ky, Bonnie; Damjanov, Nevena; Zemel, Babette S; Rickels, Michael R; Rhim, Andrew D; Rustgi, Anil K; Courneya, Kerry S; Schmitz, Kathryn H

2016-03-01

Observational studies indicate that higher volumes of physical activity are associated with improved disease outcomes among colon cancer survivors. The aim of this report is to describe the purpose, study design, methods, and recruitment results of the courage trial, a National Cancer Institute (NCI) sponsored, phase II, randomized, dose-response exercise trial among colon cancer survivors. The primary objective of the courage trial is to quantify the feasibility, safety, and physiologic effects of low-dose (150 min·week(-1)) and high-dose (300 min·week(-1)) moderate-intensity aerobic exercise compared to usual-care control group over six months. The exercise groups are provided with in-home treadmills and heart rate monitors. Between January and July 2015, 1433 letters were mailed using a population-based state cancer registry; 126 colon cancer survivors inquired about participation, and 39 were randomized onto the study protocol. Age was associated with inquiry about study participation (Pclinical, or geographic characteristics were associated with study inquiry or randomization. The final trial participant was randomized in August 2015. Six month endpoint data collection was completed in February 2016. The recruitment of colon cancer survivors into an exercise trial is feasible. The findings from this trial will inform key design aspects for future phase 2 and phase 3 randomized controlled trials to examine the efficacy of exercise to improve clinical outcomes among colon cancer survivors. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinical Trials

Medline Plus

Full Text Available ... medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for ... other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results ...

Clinical Trials

Medline Plus

Full Text Available ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ... different ethnic groups sometimes respond differently than White men to the same medical approach. As a result, ...

Efficacy of an internet-based problem-solving training for teachers: results of a randomized controlled trial

NARCIS (Netherlands)

Ebert, D.D.; Lehr, D.; BoB, L.; Riper, H.; Cuijpers, P.; Andersson, G.; Thiart, H.; Heber, E.; Berking, M.

2014-01-01

Objective The primary purpose of this randomized controlled trial (RCT) was to evaluate the efficacy of internet-based problem-solving training (iPST) for employees in the educational sector (teachers) with depressive symptoms. The results of training were compared to those of a waitlist control

2D vs. 3D imaging in laparoscopic surgery-results of a prospective randomized trial.

Science.gov (United States)

Buia, Alexander; Stockhausen, Florian; Filmann, Natalie; Hanisch, Ernst

2017-12-01

3D imaging is an upcoming technology in laparoscopic surgery, and recent studies have shown that the modern 3D technique is superior in an experimental setting. However, the first randomized controlled clinical trial in this context dates back to 1998 and showed no significant difference between 2D and 3D visualization using the first 3D generation technique, which is now more than 15 years old. Positive results measured in an experimental setting considering 3D imaging on surgical performance led us to initiate a randomized controlled pragmatic clinical trial to validate our findings in daily clinical routine. Standard laparoscopic operations (cholecystectomy, appendectomy) were preoperatively randomized to a 2D or 3D imaging system. We used a surgical comfort scale (Likert scale) and the Raw NASA Workload TLX for the subjective assessment of 2D and 3D imaging; the duration of surgery was also measured. The results of 3D imaging were statistically significant better than 2D imaging concerning the parameters "own felt safety" and "task efficiency"; the difficulty level of the procedures in the 2D and 3D groups did not differ. Overall, the Raw NASA Workload TLX showed no significance between the groups. 3D imaging could be a possible advantage in laparoscopic surgery. The results of our clinical trial show increased personal felt safety and efficiency of the surgeon using a 3D imaging system. Overall of the procedures, the findings assessed using Likert scales in terms of own felt safety and task efficiency were statistically significant for 3D imaging. The individually perceived workload assessed with the Raw NASA TLX shows no difference. Although these findings are subjective impressions of the performing surgeons without a clear benefit for 3D technology in clinical outcome, we think that these results show the capability that 3D laparoscopy can have a positive impact while performing laparoscopic procedures.

Hair-sparing whole brain radiotherapy with volumetric arc therapy in patients treated for brain metastases: dosimetric and clinical results of a phase II trial

International Nuclear Information System (INIS)

De Puysseleyr, Annemieke; Ost, Piet; Van De Velde, Joris; Speleers, Bruno; Vercauteren, Tom; Goedgebeur, Anneleen; Van Hoof, Tom; Boterberg, Tom; De Neve, Wilfried; De Wagter, Carlos

2014-01-01

To report the dosimetric results and impact of volumetric arc therapy (VMAT) on temporary alopecia and hair-loss related quality of life (QOL) in whole brain radiotherapy (WBRT). The potential of VMAT-WBRT to reduce the dose to the hair follicles was assessed. A human cadaver was treated with both VMAT-WBRT and conventional opposed field (OF) WBRT, while the subcutaneously absorbed dose was measured by radiochromic films and calculated by the planning system. The impact of these dose reductions on temporary alopecia was examined in a prospective phase II trial, with the mean score of hair loss at 1 month after VMAT-WBRT (EORTC-QOL BN20) as a primary endpoint and delivering a dose of 20 Gy in 5 fractions. An interim analysis was planned after including 10 patients to rule out futility, defined as a mean score of hair loss exceeding 56.7. A secondary endpoint was the global alopecia areata severity score measured with the “Severity of Alopecia Tool” (SALT) with a scale of 0 (no hair loss) to 100 (complete alopecia). For VMAT-WBRT, the cadaver measurements demonstrated a dose reduction to the hair follicle volume of 20.5% on average and of 41.8% on the frontal-vertex-occipital medial axis as compared to OF-WBRT. In the phase II trial, a total of 10 patients were included before the trial was halted due to futility. The EORTC BN20 hair loss score following WBRT was 95 (SD 12.6). The average median dose to the hair follicle volume was 12.6 Gy (SD 0.9), corresponding to a 37% dose reduction compared to the prescribed dose. This resulted in a mean SALT-score of 75. Compared to OF-WBRT, VMAT-WBRT substantially reduces hair follicle dose. These dose reductions could not be related to an improved QOL or SALT score

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 ...

Public demonstration projects and field trials: Accelerating commercialisation of sustainable technology in solar photovoltaics

International Nuclear Information System (INIS)

Brown, James; Hendry, Chris

2009-01-01

The paper considers the role of government funded demonstration projects and field trials (DTs) in accelerating the commercialisation of new energy technologies that meet a public good but do not have immediate market appeal [Sagar, A.D., van der Zwaan, B., 2006. Technological innovation in the energy sector: R and D, deployment, and learning-by-doing. Energy Policy 34, 2601-2608]. Drawing on an original database of DTs in the EU, Japan and USA from 1973 to 2004, we review the history of DTs in photovoltaic technology for electricity generation, and its subsequent take up as a commercial energy source. We find that DTs that are aimed purely at discovering suitable market opportunities are less successful in achieving diffusion than projects that target a particular application and concentrate resources on it. The former nevertheless have a vital role to play in the learning process, while a targeted focus is often dependent on national industrial and institutional factors.

Results of verification and investigation of wind velocity field forecast. Verification of wind velocity field forecast model

International Nuclear Information System (INIS)

Ogawa, Takeshi; Kayano, Mitsunaga; Kikuchi, Hideo; Abe, Takeo; Saga, Kyoji

1995-01-01

In Environmental Radioactivity Research Institute, the verification and investigation of the wind velocity field forecast model 'EXPRESS-1' have been carried out since 1991. In fiscal year 1994, as the general analysis, the validity of weather observation data, the local features of wind field, and the validity of the positions of monitoring stations were investigated. The EXPRESS which adopted 500 m mesh so far was improved to 250 m mesh, and the heightening of forecast accuracy was examined, and the comparison with another wind velocity field forecast model 'SPEEDI' was carried out. As the results, there are the places where the correlation with other points of measurement is high and low, and it was found that for the forecast of wind velocity field, by excluding the data of the points with low correlation or installing simplified observation stations to take their data in, the forecast accuracy is improved. The outline of the investigation, the general analysis of weather observation data and the improvements of wind velocity field forecast model and forecast accuracy are reported. (K.I.)

Yield and economic performance of organic and conventional cotton-based farming systems--results from a field trial in India.

Directory of Open Access Journals (Sweden)

Dionys Forster

Full Text Available The debate on the relative benefits of conventional and organic farming systems has in recent time gained significant interest. So far, global agricultural development has focused on increased productivity rather than on a holistic natural resource management for food security. Thus, developing more sustainable farming practices on a large scale is of utmost importance. However, information concerning the performance of farming systems under organic and conventional management in tropical and subtropical regions is scarce. This study presents agronomic and economic data from the conversion phase (2007-2010 of a farming systems comparison trial on a Vertisol soil in Madhya Pradesh, central India. A cotton-soybean-wheat crop rotation under biodynamic, organic and conventional (with and without Bt cotton management was investigated. We observed a significant yield gap between organic and conventional farming systems in the 1(st crop cycle (cycle 1: 2007-2008 for cotton (-29% and wheat (-27%, whereas in the 2(nd crop cycle (cycle 2: 2009-2010 cotton and wheat yields were similar in all farming systems due to lower yields in the conventional systems. In contrast, organic soybean (a nitrogen fixing leguminous plant yields were marginally lower than conventional yields (-1% in cycle 1, -11% in cycle 2. Averaged across all crops, conventional farming systems achieved significantly higher gross margins in cycle 1 (+29%, whereas in cycle 2 gross margins in organic farming systems were significantly higher (+25% due to lower variable production costs but similar yields. Soybean gross margin was significantly higher in the organic system (+11% across the four harvest years compared to the conventional systems. Our results suggest that organic soybean production is a viable option for smallholder farmers under the prevailing semi-arid conditions in India. Future research needs to elucidate the long-term productivity and profitability, particularly of cotton

Solution to reinforcement learning problems with artificial potential field

Institute of Scientific and Technical Information of China (English)

XIE Li-juan; XIE Guang-rong; CHEN Huan-wen; LI Xiao-li

2008-01-01

A novel method was designed to solve reinforcement learning problems with artificial potential field. Firstly a reinforcement learning problem was transferred to a path planning problem by using artificial potential field(APF), which was a very appropriate method to model a reinforcement learning problem. Secondly, a new APF algorithm was proposed to overcome the local minimum problem in the potential field methods with a virtual water-flow concept. The performance of this new method was tested by a gridworld problem named as key and door maze. The experimental results show that within 45 trials, good and deterministic policies are found in almost all simulations. In comparison with WIERING's HQ-learning system which needs 20 000 trials for stable solution, the proposed new method can obtain optimal and stable policy far more quickly than HQ-learning. Therefore, the new method is simple and effective to give an optimal solution to the reinforcement learning problem.

Dutch iliac stent trial : Long-term results in patients randomized for primary or selective stent placement

NARCIS (Netherlands)

Klein, W.M.; van der Graaf, Y.; Seegers, J.; Spithoven, J.H.; Buskens, E.; van Baal, J.G.; Buth, J.; Moll, F.L.; Overtoom, T.T.C.; van Sambeek, M.R.H.M.; Mali, W.P.T.M.

Purpose: To determine long-term results of the prospective Dutch Iliac Stent Trial. Materials and Methods: The study protocol was approved by local institutional review boards. All patients gave written informed consent. Two hundred seventy-nine patients (201 men, 78 women; mean age, 58 years) with

Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial.

Science.gov (United States)

Rushing, J; Wing, R; Wadden, T A; Knowler, W C; Lawlor, M; Evans, M; Killean, T; Montez, M; Espeland, M A; Zhang, P

2017-03-01

The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10 years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention. The ILI was designed to promote weight loss and increase physical activity. It involved a combination of group plus individual intervention sessions, with decreasing frequency of contact over the 10 years. The intervention incorporated a variety of strategies, including meal replacement products, to improve weight loss outcomes. The costs of intervention delivery were derived from staff surveys of effort and from records of intervention materials from the 16 US academic clinical trial sites. Costs were calculated from the payer perspective and presented in 2012 dollars. During the first year, when intervention delivery was most intensive, the annual cost of intervention delivery, averaged (standard deviation) across clinical sites, was $2,864.6 ($513.3) per ILI participant compared with $202.4 ($76.6) per DSE participant. As intervention intensity declined, costs decreased, such that from years 5 to 9 of the trial, the annual cost of intervention was $1,119.8 ($227.7) per ILI participant and $102.9 ($33.0) per DSE participant. Staffing accounted for the majority of costs throughout the trial, with meal replacements and materials to promote adherence accounting for smaller shares. The sustained weight losses produced by the Look AHEAD intervention were supported by intervention costs that were within the range of other weight loss programmes. Future work will include an evaluation of the cost-effectiveness of the ILI and will contain additional follow-up data.

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

Science.gov (United States)

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

2010-09-10

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

Couple-Based Psychosexual Support Following Prostate Cancer Surgery: Results of a Feasibility Pilot Randomized Control Trial.

Science.gov (United States)

Robertson, Jane; McNamee, Phillip; Molloy, Gerry; Hubbard, Gill; McNeill, Alan; Bollina, Prasad; Kelly, Daniel; Forbat, Liz

2016-08-01

Surgery for prostate cancer can result in distressing side effects such as sexual difficulties, which are associated with lower levels of dyadic functioning. The study developed and tested an intervention to address sexual, relational, and emotional aspects of the relationship after prostate cancer by incorporating elements of family systems theory and sex therapy. To develop and test the feasibility and acceptability of relational psychosexual treatment for couples with prostate cancer, determine whether a relational-psychosexual intervention is feasible and acceptable for couples affected by prostate cancer, and determine the parameters for a full-scale trial. Forty-three couples were recruited for this pilot randomized controlled trial and received a six-session manual-based psychosexual intervention or usual care. Outcomes were measured before, after, and 6 months after the intervention. Acceptability and feasibility were established from recruitment and retention rates and adherence to the manual. The primary outcome measurement was the sexual bother subdomain of the Expanded Prostate Cancer Index Composite. The Hospital Anxiety and Depression Scale and the 15-item Systemic Clinical Outcome and Routine Evaluation (SCORE-15) were used to measure emotional and relational functioning, respectively. The intervention was feasible and acceptable. The trial achieved adequate recruitment (38%) and retention (74%) rates. The intervention had a clinically and statistically significant effect on sexual bother immediately after the intervention. Small decreases in anxiety and depression were observed for the intervention couples, although these were not statistically significant. Practitioners reported high levels of adherence to the manual. The clinically significant impact on sexual bother and positive feedback on the study's feasibility and acceptability indicate that the intervention should be tested in a multicenter trial. The SCORE-15 lacked specificity for this

Prosthetic above-knee femoropopliteal bypass grafting: five-year results of a randomized trial.

Science.gov (United States)

Green, R M; Abbott, W M; Matsumoto, T; Wheeler, J R; Miller, N; Veith, F J; Money, S; Garrett, H E

2000-03-01

This trial was designed to identify factors affecting patency rates of primary prosthetic above-knee femoropopliteal bypass grafts at 5 years. A multi-institutional, prospective trial randomized 240 patients to compare patency rates of Gore-tex and Hemashield above-knee femoropopliteal bypass grafts at 5 years. Univariate comparisons of patency between levels of each prognostic variable were made with the Kaplan-Meier method. Variables that had a univariate P value less than.25 or those known to be important were submitted to a Cox regression analysis. The patient survival rate at 5 years was 59.4%. There were no differences in primary or secondary patency rates at 5 years between the two graft materials (primary, 45% vs 43% and secondary, 68% vs 68%). The risk for graft occlusion was significantly increased for patients younger than 65 years (2.1; P =.001) and for grafts with a diameter less than 7 mm (1.65; P =.0219). Variables with no apparent independent effect on patency rates were smoking status, runoff, diabetes mellitus, sex, presenting symptoms, and postoperative treatment with aspirin or Coumadin. Noninvasive test results were not predictive of subsequent graft function. Although the type of prosthetic used for above-knee femoropopliteal bypass grafts does not affect 5-year patency rates, age and graft size do influence results. These factors should be considered before a prosthetic bypass grafting procedure. Furthermore, these data should serve as a contemporary standard, with which evolving and conventional procedures can be compared.

Guidelines for time-to-event end point definitions in breast cancer trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)†.

Science.gov (United States)

Gourgou-Bourgade, S; Cameron, D; Poortmans, P; Asselain, B; Azria, D; Cardoso, F; A'Hern, R; Bliss, J; Bogaerts, J; Bonnefoi, H; Brain, E; Cardoso, M J; Chibaudel, B; Coleman, R; Cufer, T; Dal Lago, L; Dalenc, F; De Azambuja, E; Debled, M; Delaloge, S; Filleron, T; Gligorov, J; Gutowski, M; Jacot, W; Kirkove, C; MacGrogan, G; Michiels, S; Negreiros, I; Offersen, B V; Penault Llorca, F; Pruneri, G; Roche, H; Russell, N S; Schmitt, F; Servent, V; Thürlimann, B; Untch, M; van der Hage, J A; van Tienhoven, G; Wildiers, H; Yarnold, J; Bonnetain, F; Mathoulin-Pélissier, S; Bellera, C; Dabakuyo-Yonli, T S

2015-05-01

Using surrogate end points for overall survival, such as disease-free survival, is increasingly common in randomized controlled trials. However, the definitions of several of these time-to-event (TTE) end points are imprecisely which limits interpretation and cross-trial comparisons. The estimation of treatment effects may be directly affected by the definitions of end points. The DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for randomized cancer clinical trials (RCTs) in breast cancer. A literature review was carried out to identify TTE end points (primary or secondary) reported in publications of randomized trials or guidelines. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points based on a validated consensus method that formalize the degree of agreement among experts. Recommended guidelines for the definitions of TTE end points commonly used in RCTs for breast cancer are provided for non-metastatic and metastatic settings. The use of standardized definitions should facilitate comparisons of trial results and improve the quality of trial design and reporting. These guidelines could be of particular interest to those involved in the design, conducting, reporting, or assessment of RCT. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Soil stabilization field trial : final report.

Science.gov (United States)

2006-01-01

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

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

Science.gov (United States)

2012-07-09

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

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

2010-10-01

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

Formulations of the endophytic bacterium Bacillus subtilis Tu-100 suppress Sclerotinia sclerotiorum on oilseed rape and improve plant vigor in field trials conducted at separate locations

Science.gov (United States)

Sclerotinia sclerotiorum causes serious yield losses in crops in The People’s Republic of China. Two formulations of oilseed rape seed containing the endophytic bacterium Bacillus subtilis Tu-100 were evaluated for suppression of this pathogen in field trials conducted at two independent locations....

Field trial of 160 Gb/s all-optical packet switching

NARCIS (Netherlands)

Liu, Y.; Herrera Llorente, J.; Raz, O.; Tangdiongga, E.; Marti, J.; Ramos, F.; Maxwell, G.D.; Poustie, A.; Mulvad, H.C.H.; Hill, M.T.; Waardt, de H.; Khoe, G.D.; Koonen, A.M.J.; Dorren, H.J.S.; Nakano, Y.

2007-01-01

We present the results of a transmission experiment, over 110 km of field installed fiber, for an all-optical 160 Gb/s packet switching system. The system uses in-band optical labels which are processed entirely in the optical domain using a narrow-band all-optical filter. The label decision

Soil acidification occurs under ambient conditions but is retarded by repeated drought: Results of a field-scale climate manipulation experiment

Energy Technology Data Exchange (ETDEWEB)

Kopittke, G.R.; Tietema, A., E-mail: A.Tietema@uva.nl; Verstraten, J.M.

2012-11-15

Acid atmospheric emissions within Europe and North America have decreased strongly since 1985 and most recent acidification studies have focused on the changes occurring within ecosystems as a result of this decreased deposition. This current study documents a soil acidification trend under ambient N deposition conditions over a 13 year period, suggesting that acidification continues to be a process of concern at this Calluna vulgaris dominated heathland with an acidic sandy soil. The annual manipulation of climatic conditions on this heathland simulated the predicted summer rainfall reduction (drought) and resulted in a long term retardation of the soil acidification trend. The pH of the soil solution significantly decreased over the course of the trial for both treatments, however, in the final 2 years the decline continued only in the Control treatment. This retardation is primarily associated with the reduction in rainfall leading to lower drainage rates, reduced loss of cations and therefore reduced lowering of the soil acid neutralizing capacity (ANC). However, a change in the underlying mechanisms also indicated that N transformations became less important in the Drought treatment. This change corresponded to an increase in groundcover of an air-pollution tolerant moss species and it is hypothesized that this increasing moss cover filtered an increasing quantity of deposited N, thus reducing the N available for transformation. A soil acidification lag time is expected to increase between the two treatments due to the cumulative disparity in cation retention and rates of proton formation. To the authors' knowledge, this is the first study in which such acidification trends have been demonstrated in a field-scale climate manipulation experiment. -- Highlights: Black-Right-Pointing-Pointer A unique investigation of acidification on a field-scale climate manipulation trial. Black-Right-Pointing-Pointer Soil acidification occurred over 13 years of ambient N

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

Energy Technology Data Exchange (ETDEWEB)

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

2016-06-15

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

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

Science.gov (United States)

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

2015-01-01

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

Extended wearing trial of Trifield lens device for 'tunnel vision'.

Science.gov (United States)

Woods, Russell L; Giorgi, Robert G; Berson, Eliot L; Peli, Eli

2010-05-01

Severe visual field constriction (tunnel vision) impairs the ability to navigate and walk safely. We evaluated Trifield glasses as a mobility rehabilitation device for tunnel vision in an extended wearing trial. Twelve patients with tunnel vision (5-22 degrees wide) due to retinitis pigmentosa or choroideremia participated in the 5-visit wearing trial. To expand the horizontal visual field, one spectacle lens was fitted with two apex-to-apex prisms that vertically bisected the pupil on primary gaze. This provides visual field expansion at the expense of visual confusion (two objects with the same visual direction). Patients were asked to wear these spectacles as much as possible for the duration of the wearing trial (median 8, range 6-60 weeks). Clinical success (continued wear, indicating perceived overall benefit), visual field expansion, perceived direction and perceived visual ability were measured. Of 12 patients, nine chose to continue wearing the Trifield glasses at the end of the wearing trial. Of those nine patients, at long-term follow-up (35-78 weeks), three reported still wearing the Trifield glasses. Visual field expansion (median 18, range 9-38 degrees) was demonstrated for all patients. No patient demonstrated adaptation to the change in visual direction produced by the Trifield glasses (prisms). For reported difficulty with obstacles, some differences between successful and non-successful wearers were found. Trifield glasses provided reported benefits in obstacle avoidance to 7 of the 12 patients completing the wearing trial. Crowded environments were particularly difficult for most wearers. Possible reasons for long-term discontinuation and lack of adaptation to perceived direction are discussed.

Perturbation theory for BAO reconstructed fields: One-loop results in the real-space matter density field

Science.gov (United States)

Hikage, Chiaki; Koyama, Kazuya; Heavens, Alan

2017-08-01

We compute the power spectrum at one-loop order in standard perturbation theory for the matter density field to which a standard Lagrangian baryonic acoustic oscillation (BAO) reconstruction technique is applied. The BAO reconstruction method corrects the bulk motion associated with the gravitational evolution using the inverse Zel'dovich approximation (ZA) for the smoothed density field. We find that the overall amplitude of one-loop contributions in the matter power spectrum substantially decreases after reconstruction. The reconstructed power spectrum thereby approaches the initial linear spectrum when the smoothed density field is close enough to linear, i.e., the smoothing scale Rs≳10 h-1 Mpc . On smaller Rs, however, the deviation from the linear spectrum becomes significant on large scales (k ≲Rs-1 ) due to the nonlinearity in the smoothed density field, and the reconstruction is inaccurate. Compared with N-body simulations, we show that the reconstructed power spectrum at one-loop order agrees with simulations better than the unreconstructed power spectrum. We also calculate the tree-level bispectrum in standard perturbation theory to investigate non-Gaussianity in the reconstructed matter density field. We show that the amplitude of the bispectrum significantly decreases for small k after reconstruction and that the tree-level bispectrum agrees well with N-body results in the weakly nonlinear regime.

Behavioral and locomotor measurements using an open field activity monitoring system for skeletal muscle diseases.

Science.gov (United States)

Tatem, Kathleen S; Quinn, James L; Phadke, Aditi; Yu, Qing; Gordish-Dressman, Heather; Nagaraju, Kanneboyina

2014-09-29

The open field activity monitoring system comprehensively assesses locomotor and behavioral activity levels of mice. It is a useful tool for assessing locomotive impairment in animal models of neuromuscular disease and efficacy of therapeutic drugs that may improve locomotion and/or muscle function. The open field activity measurement provides a different measure than muscle strength, which is commonly assessed by grip strength measurements. It can also show how drugs may affect other body systems as well when used with additional outcome measures. In addition, measures such as total distance traveled mirror the 6 min walk test, a clinical trial outcome measure. However, open field activity monitoring is also associated with significant challenges: Open field activity measurements vary according to animal strain, age, sex, and circadian rhythm. In addition, room temperature, humidity, lighting, noise, and even odor can affect assessment outcomes. Overall, this manuscript provides a well-tested and standardized open field activity SOP for preclinical trials in animal models of neuromuscular diseases. We provide a discussion of important considerations, typical results, data analysis, and detail the strengths and weaknesses of open field testing. In addition, we provide recommendations for optimal study design when using open field activity in a preclinical trial.

Field Trial and Molecular Characterization of RNAi-Transgenic Tomato Plants That Exhibit Resistance to Tomato Yellow Leaf Curl Geminivirus.

Science.gov (United States)

Fuentes, Alejandro; Carlos, Natacha; Ruiz, Yoslaine; Callard, Danay; Sánchez, Yadira; Ochagavía, María Elena; Seguin, Jonathan; Malpica-López, Nachelli; Hohn, Thomas; Lecca, Maria Rita; Pérez, Rosabel; Doreste, Vivian; Rehrauer, Hubert; Farinelli, Laurent; Pujol, Merardo; Pooggin, Mikhail M

2016-03-01

RNA interference (RNAi) is a widely used approach to generate virus-resistant transgenic crops. However, issues of agricultural importance like the long-term durability of RNAi-mediated resistance under field conditions and the potential side effects provoked in the plant by the stable RNAi expression remain poorly investigated. Here, we performed field trials and molecular characterization studies of two homozygous transgenic tomato lines, with different selection markers, expressing an intron-hairpin RNA cognate to the Tomato yellow leaf curl virus (TYLCV) C1 gene. The tested F6 and F4 progenies of the respective kanamycin- and basta-resistant plants exhibited unchanged field resistance to TYLCV and stably expressed the transgene-derived short interfering RNA (siRNAs) to represent 6 to 8% of the total plant small RNAs. This value outnumbered the average percentage of viral siRNAs in the nontransformed plants exposed to TYLCV-infested whiteflies. As a result of the RNAi transgene expression, a common set of up- and downregulated genes was revealed in the transcriptome profile of the plants selected from either of the two transgenic events. A previously unidentified geminivirus causing no symptoms of viral disease was detected in some of the transgenic plants. The novel virus acquired V1 and V2 genes from TYLCV and C1, C2, C3, and C4 genes from a distantly related geminivirus and, thereby, it could evade the repressive sequence-specific action of transgene-derived siRNAs. Our findings shed light on the mechanisms of siRNA-directed antiviral silencing in transgenic plants and highlight the applicability limitations of this technology as it may alter the transcriptional pattern of nontarget genes.

Variational estimate of the vacuum state of the SU(2) lattice gauge theory with a disordered trial wave function

International Nuclear Information System (INIS)

Heys, D.W.; Stump, D.R.

1984-01-01

The variational principle is used to estimate the ground state of the Kogut-Susskind Hamiltonian of the SU(2) lattice gauge theory, with a trial wave function for which the magnetic fields on different plaquettes are uncorrelated. This trial function describes a disordered state. The energy expectation value is evaluated by a Monte Carlo method. The variational results are compared to similar results for a related Abelian gauge theory. Also, the expectation value of the Wilson loop operator is computed for the trial state, and the resulting estimate of the string tension is compared to the prediction of asymptotic freedom

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

Science.gov (United States)

2011-08-08

...] Oral Rabies Vaccine Trial; Availability of a Risk Assessment and an Environmental Assessment AGENCY... environmental assessment relative to an oral rabies vaccination field trial in West Virginia. The environmental... rabies vaccine, analyzes the use of that vaccine in field safety and efficacy trials in West Virginia...

OARSI Clinical Trials Recommendations

DEFF Research Database (Denmark)

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

2015-01-01

The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...

Determining who responds better to a computer- vs. human-delivered physical activity intervention: results from the community health advice by telephone (CHAT) trial

Science.gov (United States)

2013-01-01

Background Little research has explored who responds better to an automated vs. human advisor for health behaviors in general, and for physical activity (PA) promotion in particular. The purpose of this study was to explore baseline factors (i.e., demographics, motivation, interpersonal style, and external resources) that moderate intervention efficacy delivered by either a human or automated advisor. Methods Data were from the CHAT Trial, a 12-month randomized controlled trial to increase PA among underactive older adults (full trial N = 218) via a human advisor or automated interactive voice response advisor. Trial results indicated significant increases in PA in both interventions by 12 months that were maintained at 18-months. Regression was used to explore moderation of the two interventions. Results Results indicated amotivation (i.e., lack of intent in PA) moderated 12-month PA (d = 0.55, p  0.12). Conclusions Results provide preliminary evidence for generating hypotheses about pathways for supporting later clinical decision-making with regard to the use of either human- vs. computer-delivered interventions for PA promotion. PMID:24053756

Adaptive designs in clinical trials

Directory of Open Access Journals (Sweden)

Suresh Bowalekar

2011-01-01

Full Text Available In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

Adaptive designs in clinical trials.

Science.gov (United States)

Bowalekar, Suresh

2011-01-01

In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA)/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

The impact of radiologists' expertise on screen results decisions in a CT lung cancer screening trial

Energy Technology Data Exchange (ETDEWEB)

Heuvelmans, Marjolein A.; Vliegenthart, Rozemarijn [University of Groningen, University Medical Center Groningen, Center for Medical Imaging - North East Netherlands, Groningen (Netherlands); University of Groningen / University Medical Center Groningen, Department of Radiology, Groningen (Netherlands); Oudkerk, Matthijs [University of Groningen, University Medical Center Groningen, Center for Medical Imaging - North East Netherlands, Groningen (Netherlands); Jong, Pim A. de; Mali, Willem P. [University Medical Center Utrecht, Department of Radiology, Utrecht (Netherlands); Groen, Harry J.M. [University of Groningen, University Medical Center Groningen, Department of Pulmonology, Groningen (Netherlands)

2014-11-04

To evaluate the impact of radiological expertise on screen result decisions in a CT lung cancer screening trial. In the NELSON lung cancer screening trial, the baseline CT result was based on the largest lung nodule's volume. The protocol allowed radiologists to manually adjust screen results in cases of high suspicion of benign or malignant nodule nature. Participants whose baseline CT result was based on a solid or part-solid nodule were included in this study. Adjustments by radiologists at baseline were evaluated. Histology was the reference for diagnosis or to confirm benignity and stability on subsequent CT examinations. A total of 3,318 participants (2,796 male, median age 58.0 years) were included. In 195 participants (5.9 %) the initial baseline screen result was adjusted by the radiologist. Adjustment was downwards from positive or indeterminate to negative in two and 119 participants, respectively, and from positive to indeterminate in 65 participants. None of these nodules turned out to be malignant. In 9/195 participants (4.6 %) the screen result was adjusted upwards from negative to indeterminate or indeterminate to positive; two nodules were malignant. In one in 20 cases of baseline lung cancer screening, nodules were reclassified by the radiologist, leading to a reduction of false-positive screen results. (orig.)

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 ...

Paternal inheritance of plastid-encoded transgenes in Petunia hybrida in the greenhouse and under field conditions

Directory of Open Access Journals (Sweden)

Patricia Horn

2017-12-01

Full Text Available As already demonstrated in greenhouse trials, outcrossing of transgenic plants can be drastically reduced via transgene integration into the plastid. We verified this result in the field with Petunia, for which the highest paternal leakage has been observed. The variety white 115 (W115 served as recipient and Pink Wave (PW and the transplastomic variant PW T16, encoding the uidA reporter gene, as pollen donor. While manual pollination in the greenhouse led to over 90% hybrids for both crossings, the transgenic donor resulted only in 2% hybrids in the field. Nevertheless paternal leakage was detected in one case which proves that paternal inheritance of plastid-located transgenes is possible under artificial conditions. In the greenhouse, paternal leakage occurred in a frequency comparable to published results. As expected natural pollination reduced the hybrid formation in the field from 90 to 7.6% and the transgenic donor did not result in any hybrid. Keywords: Paternal plastid inheritance, Transgene confinement, Greenhouse, Field trial, Pollen mediated gene flow

Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial

DEFF Research Database (Denmark)

Punthakee, Z; Bosch, J; Dagenais, G

2012-01-01

AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs (rosiglit......AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs...

Field Trial of LANL On-Line Advanced Enrichment Monitor for UF6 GCEP

Energy Technology Data Exchange (ETDEWEB)

Ianakiev, Kiril D. [Los Alamos National Laboratory; Lombardi, Marcie [Los Alamos National Laboratory; MacArthur, Duncan W. [Los Alamos National Laboratory; Parker, Robert F. [Los Alamos National Laboratory; Smith, Morag K. [Los Alamos National Laboratory; Keller, Clifford [Los Alamos National Laboratory; Friend, Peter [URENCO; Dunford, Andrew [URENCO

2012-07-13

The outline of this presentation is: (1) Technology basis of on-line enrichment monitoring; (2) Timescale of trial; (3) Description of installed equipment; (4) Photographs; (5) Results; (6) Possible further development; and (7) Conclusions. Summary of the good things about the Advanced Enrichment Monitor (AEM) performance is: (1) High accuracy - normally better than 1% relative, (2) Active system as accurate as passive system, (3) Fast and accurate detection of enrichment changes, (4) Physics is well understood, (5) Elegant method for capturing pressure signal, and (6) Data capture is automatic, low cost and fast. A couple of negative things are: (1) Some jumps in measured passive enrichment - of around +2% relative (due to clock errors?); and (2) Data handling and evaluation is off-line, expensive and very slow. Conclusions are: (1) LANL AEM is being tested on E23 plant at Capenhurst; (2) The trial is going very well; (3) AEM could detect production of HEU at potentially much lower cost than existing CEMO; (4) AEM can measure {sup 235}U assay accurately; (5) Active system using X-Ray source would avoid need for pressure measurement; (6) Substantial work lies ahead to go from current prototype to a production instrument.

Field trial of the spatial repellency of metofluthrin-impregnated plastic strip against mosquitoes in shelters without walls (Beruga) in Lombok, Indonesia.

OpenAIRE

Kawada, Hitoshi; Maekawa, Yoshihide; Takagi, Masahiro

2005-01-01

Field trials on the spatial repellency of metofluthrin-impregnated plastic strips for mosquitoes present in shelters without walls (beruga) were carried out in Lombok, Indonesia. A major reduction in the incidence of human biting by Culex quinquefasciatus was achieved, and the use of two strips per beruga repelled >60% of the mosquitoes for at least 11 wk while four strips repelled >60% of the mosquitoes for more than 15 weeks. The technique was found to be a practical long-term solution for ...

Expression of endogenous proteins in maize hybrids in a multi-location field trial in India.

Science.gov (United States)

Gutha, Linga R; Purushottam, Divakar; Veeramachaneni, Aruna; Tigulla, Sarita; Kodappully, Vikas; Enjala, Chandana; Rajput, Hitendrasinh; Anderson, Jennifer; Hong, Bonnie; Schmidt, Jean; Bagga, Shveta

2018-05-17

Genetically modified (GM) crops undergo large scale multi-location field trials to characterize agronomics, composition, and the concentration of newly expressed protein(s) [herein referred to as transgenic protein(s)]. The concentration of transgenic proteins in different plant tissues and across the developmental stages of the plant is considered in the safety assessment of GM crops. Reference or housekeeping proteins are expected to maintain a relatively stable expression pattern in healthy plants given their role in cellular functions. Understanding the effects of genotype, growth stage and location on the concentration of endogenous housekeeping proteins may provide insight into the contribution these factors could have on transgenic protein concentrations in GM crops. The concentrations of three endogenous proteins (actin, elongation factor 1-alpha, and glyceraldehyde 3-phosphate dehydrogenase) were measured in several different maize hybrids grown across multiple field locations over 2 years. Leaf samples were collected from healthy plants at three developmental stages across the growing seasons, and protein concentrations were quantified by indirect enzyme-linked immunosorbent assay (ELISA) for each protein. In general, the concentrations of these three endogenous proteins were relatively consistent across hybrid backgrounds, when compared within one growth stage and location (2-26%CV), whereas the concentrations of proteins in the same hybrid and growth stage across different locations were more variable (12-64%CV). In general, the protein concentrations in 2013 and 2014 show similar trends in variability. Some degree of variability in protein concentrations should be expected for both transgenic and endogenous plant-expressed proteins. In the case of GM crops, the potential variation in protein concentrations due to location effects is captured in the current model of multi-location field testing.

[Placebo-controlled trials in schizophrenia].

Science.gov (United States)

Melamed, Yuval; Davidson, Michael; Bleich, Avi

2004-03-01

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

Contemporary Aspects of Marketing in Clinical Trials Including Segments of IT and Technology Transfer.

Science.gov (United States)

Stamenovic, Milorad; Dobraca, Amra; Smajlovic, Mersiha

2018-01-01

The aim of this paper is to present the marketing strategy and the application of management (marketing management) and advertising in order to increase the efficiency of innovative approach in clinical trials that include and involve the use of new technologies and transfer of technologies. This paper has a descriptive character and represents a narrative review of the literature and new model implementation. Marketing models are primarily used to improve the inclusion of a larger (and appropriate) number of patients, but they can be credited for the stay and monitoring of patients in the trial. Regulatory mechanisms play an important role in the application of various marketing strategies within clinical trials. The value for the patient as the most important stakeholder is defined in the field of clinical trials according to Kotler's value model for the consumer. In order to achieve the best results it is important to adequately examine all the elements of clinical trials and apply this knowledge in creation of a marketing plan that will be made in accordance with the legal regulations defined globally and locally. In this paper, two challenges have been highlighted for the adequate application of marketing tools in the field of clinical trials, namely: defining business elements in order to provide an adequate marketing approach for clinical trials and technology transfer and ensuring uniformity and regulatory affirmation of marketing attitudes in clinical trials in all regions in which they are carried out in accordance with ICH-GCP and valid regulations.

Five-year safety and performance results from the Argus II Retinal Prosthesis System clinical trial

Science.gov (United States)

da Cruz, Lyndon; Dorn, Jessy D.; Humayun, Mark S.; Dagnelie, Gislin; Handa, James; Barale, Pierre-Olivier; Sahel, José-Alain; Stanga, Paulo E.; Hafezi, Farhad; Safran, Avinoam B.; Salzmann, Joel; Santos, Arturo; Birch, David; Spencer, Rand; Cideciyan, Artur V.; de Juan, Eugene; Duncan, Jacque L.; Eliott, Dean; Fawzi, Amani; Olmos de Koo, Lisa C.; Ho, Allen C.; Brown, Gary; Haller, Julia; Regillo, Carl; Del Priore, Lucian V.; Arditi, Aries; Greenberg, Robert J.

2016-01-01

Purpose The Argus® II Retinal Prosthesis System (Second Sight Medical Products, Inc., Sylmar, CA) was developed to restore some vision to patients blind from retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception due to end-stage RP. Design The study is a prospective, multicenter, single-arm, clinical trial. Within-patient controls included the non-implanted fellow eye and patients' native residual vision compared to their vision when using the System. Subjects There were 30 subjects in 10 centers in the U.S. and Europe. Methods The worse-seeing eye of blind patients was implanted with the Argus II System. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. Main Outcome Measures The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by three computer-based, objective tests. Secondary measures included functional vision performance on objectively-scored real-world tasks. Results Twenty-four out of 30 patients remained implanted with functioning Argus II Systems at 5 years post-implant. Only one additional serious adverse event was experienced since the 3-year time point. Patients performed significantly better with the System ON than OFF on all visual function tests and functional vision tasks. Conclusions The five-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada. PMID:27453256

TRIAL BURN RESULTS AND FUTURE ACTIVITES OF THE EPA MOBILE INCINERATOR

Science.gov (United States)

The EPA Mobile Incinerator has demonstrated its ability to successfully destroy dioxin. A trial burn conducted in 1987 demonstrated the incinerator's ability to destroy a wide variety of compounds. The destruction and removal efficiency (DRE) of carbon tetrachloride, hexachloro...

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

Science.gov (United States)

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

2018-05-01

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

Grain yield increase in cereal variety mixtures: A meta-analysis of field trials

DEFF Research Database (Denmark)

Kiær, Lars Pødenphant; Skovgaard, Ib; Østergård, Hanne

2009-01-01

on grain yield. To investigate the prevalence and preconditions for positive mixing effects, reported grain yields of variety mixtures and pure variety stands were obtained from previously published variety trials, converted into relative mixing effects and combined using meta-analysis. Furthermore...... as meeting the criteria for inclusion in the meta-analysis; on the other hand, nearly 200 studies were discarded. The accepted studies reported results on both winter and spring types of each crop species. Relative mixing effects ranged from 30% to 100% with an overall meta-estimate of at least 2.7% (p

Low-dose and high-dose acetylsalicylic acid, with and without dipyridamole: a review of clinical trial results

NARCIS (Netherlands)

Tijssen, J. G.

1998-01-01

Publication of the results of the second European Stroke Prevention Study (ESPS-2) provided the incentive for an update of the meta-analyses of aspirin and dipyridamole in the secondary prevention of stroke. After review of published randomized trials of prolonged treatment with aspirin,

Microbial control of Agrilus planipennis (Coleoptera: Buprestidae) with Beauveria bassiana strain GHA: field applications

Science.gov (United States)

Houping Liu; Leah S. Bauer

2008-01-01

The effects of Beauveria bassiana strain GHA, applied as BotaniGard ES, on newly colonised and well-established populations of emerald ash borer, Agrilus planipennis (Coleoptera: Buprestidae) were evaluated in the field using foliar and trunk sprays in Michigan in 2004-2005. Results from field trials at a newly colonised white ash...

Current clinical trials testing combinations of immunotherapy and radiation.

Science.gov (United States)

Crittenden, Marka; Kohrt, Holbrook; Levy, Ronald; Jones, Jennifer; Camphausen, Kevin; Dicker, Adam; Demaria, Sandra; Formenti, Silvia

2015-01-01

Preclinical evidence of successful combinations of ionizing radiation with immunotherapy has inspired testing the translation of these results to the clinic. Interestingly, the preclinical work has consistently predicted the responses encountered in clinical trials. The first example came from a proof-of-principle trial started in 2001 that tested the concept that growth factors acting on antigen-presenting cells improve presentation of tumor antigens released by radiation and induce an abscopal effect. Granulocyte-macrophage colony-stimulating factor was administered during radiotherapy to a metastatic site in patients with metastatic solid tumors to translate evidence obtained in a murine model of syngeneic mammary carcinoma treated with cytokine FLT-3L and radiation. Subsequent clinical availability of vaccines and immune checkpoint inhibitors has triggered a wave of enthusiasm for testing them in combination with radiotherapy. Examples of ongoing clinical trials are described in this report. Importantly, most of these trials include careful immune monitoring of the patients enrolled and will generate important data about the proimmunogenic effects of radiation in combination with a variety of immune modulators, in different disease settings. Results of these studies are building a platform of evidence for radiotherapy as an adjuvant to immunotherapy and encourage the growth of this novel field of radiation oncology. Copyright © 2015 Elsevier Inc. All rights reserved.

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

Science.gov (United States)

Kamijo, Keita; Takeda, Yuji

2013-08-01

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

Long term effectiveness on prescribing of two multifaceted educational interventions: results of two large scale randomized cluster trials.

Directory of Open Access Journals (Sweden)

Nicola Magrini

Full Text Available INTRODUCTION: Information on benefits and risks of drugs is a key element affecting doctors' prescribing decisions. Outreach visits promoting independent information have proved moderately effective in changing prescribing behaviours. OBJECTIVES: Testing the short and long-term effectiveness on general practitioners' prescribing of small groups meetings led by pharmacists. METHODS: Two cluster open randomised controlled trials (RCTs were carried out in a large scale NHS setting. Ad hoc prepared evidence based material were used considering a therapeutic area approach--TEA, with information materials on osteoporosis or prostatic hyperplasia--and a single drug oriented approach--SIDRO, with information materials on me-too drugs of 2 different classes: barnidipine or prulifloxacin. In each study, all 115 Primary Care Groups in a Northern Italy area (2.2 million inhabitants, 1737 general practitioners were randomised to educational small groups meetings, in which available evidence was provided together with drug utilization data and clinical scenarios. Main outcomes were changes in the six-months prescription of targeted drugs. Longer term results (24 and 48 months were also evaluated. RESULTS: In the TEA trial, one of the four primary outcomes showed a reduction (prescription of alfuzosin compared to tamsulosin and terazosin in benign prostatic hyperplasia: prescribing ratio -8.5%, p = 0.03. Another primary outcome (prescription of risedronate showed a reduction at 24 and 48 months (-7.6%, p = 0.02; and -9,8%, p = 0.03, but not at six months (-5.1%, p = 0.36. In the SIDRO trial both primary outcomes showed a statistically significant reduction (prescription of barnidipine -9.8%, p = 0.02; prescription of prulifloxacin -11.1%, p = 0.04, which persisted or increased over time. INTERPRETATION: These two cluster RCTs showed the large scale feasibility of a complex educational program in a NHS setting, and its potentially

Recruitment to and pilot results of the PACES randomized trial of physical exercise during adjuvant chemotherapy for colon cancer.

Science.gov (United States)

van Waart, Hanna; Stuiver, Martijn M; van Harten, Wim H; Geleijn, Edwin; de Maaker-Berkhof, Marianne; Schrama, Jolanda; Geenen, Maud M; Meerum Terwogt, Jetske M; van den Heiligenberg, Simone M; Hellendoorn-van Vreeswijk, Jeannette A J H; Sonke, Gabe S; Aaronson, Neil K

2018-01-01

We report the recruitment rate, reasons for and factors influencing non-participation, and descriptive results of a randomized controlled trial of two different exercise programs for patients with colon cancer undergoing adjuvant chemotherapy. Participants were randomized to a low-intensity, home-based program (Onco-Move), a moderate- to high-intensity, combined supervised resistance and aerobic exercise program (OnTrack), or Usual Care. Non-participants provided reasons for non-participation and were asked to complete a questionnaire assessing behavioral and attitudinal variables. Trial participants completed performance-based and self-reported outcome measures prior to randomization, at the end of chemotherapy, and at the 6-month follow-up. Twenty-three of 63 referred patients agreed to participate in the trial. All 40 non-participants provided reasons for non-participation. Forty-five percent of the non-participants completed the questionnaire. Those who did not want to exercise had higher fatigue scores at baseline and a more negative attitude toward exercise. Compliance to both programs was high and no adverse events occurred. On average, the colon cancer participants were able to maintain or improve their physical fitness levels and maintain or decrease their fatigue levels during chemotherapy and follow-up. Recruitment of patients with colon cancer to a physical exercise trial during adjuvant chemotherapy proved to be difficult, underscoring the need to develop more effective strategies to increase participation rates. Both home-based and supervised programs are safe and feasible in patients with colon cancer undergoing chemotherapy. Effectiveness needs to be established in a larger trial. Netherlands Trial Register - NTR2159.

OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis.

Science.gov (United States)

Kraus, V B; Blanco, F J; Englund, M; Henrotin, Y; Lohmander, L S; Losina, E; Önnerfjord, P; Persiani, S

2015-05-01

The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety of reasons but in particular, to determine whether biomarkers are useful in identifying those individuals most likely to receive clinically important benefits from an intervention; and to determine whether biomarkers are useful for identifying individuals at earlier stages of OA in order to institute treatment at a time more amenable to disease modification. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

[Microdose clinical trial--impact of PET molecular imaging].

Science.gov (United States)

Yano, Tsuneo; Watanabe, Yasuyoshi

2010-10-01

Microdose (MD) clinical trial and exploratory IND study including sub-therapeutic dose and therapeutic dose which are higher than microdoses are expected to bring about innovations in drug development. The outlines of guidances for microdose clinical trial and ICH-M3 (R2) issued by the MHLW in June, 2008, and February, 2010, are first explained, respectively, and some examples of their application to clinical developments of therapeutic drugs in the infection and cancer fields are introduced. Especially, thanks to the progress of molecular imaging research, a new field of drug development is explored by using imaging biomarkers for efficacy or safety evaluation which visualize biomarkers by PET imaging agents. Finally, the roadmap for drug development in infection and cancer fields utilizing PET molecular imaging is discussed.

Evaluating the Accuracy of Results for Teacher Implemented Trial-Based Functional Analyses.

Science.gov (United States)

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

2015-09-01

Trial-based functional analysis (TBFA) allows for the systematic and experimental assessment of challenging behavior in applied settings. The purposes of this study were to evaluate a professional development package focused on training three Head Start teachers to conduct TBFAs with fidelity during ongoing classroom routines. To assess the accuracy of the TBFA results, the effects of a function-based intervention derived from the TBFA were compared with the effects of a non-function-based intervention. Data were collected on child challenging behavior and appropriate communication. An A-B-A-C-D design was utilized in which A represented baseline, and B and C consisted of either function-based or non-function-based interventions counterbalanced across participants, and D represented teacher implementation of the most effective intervention. Results showed that the function-based intervention produced greater decreases in challenging behavior and greater increases in appropriate communication than the non-function-based intervention for all three children. © The Author(s) 2015.

Proteomic analysis of Sydney Rock oysters (Saccostrea glomerata) exposed to metal contamination in the field

International Nuclear Information System (INIS)

Thompson, Emma L.; Taylor, Daisy A.; Nair, Sham V.; Birch, Gavin; Hose, Grant C.; Raftos, David A.

2012-01-01

This study used proteomics to assess the impacts of metal contamination in the field on Sydney Rock oysters. Oysters were transplanted into Lake Macquarie, NSW, for two weeks in both 2009 and 2010. Two-dimensional electrophoresis identified changes in protein expression profiles of oyster haemolymph between control and metal contaminated sites. There were unique protein expression profiles for each field trial. Principal components analysis attributed these differences in oyster proteomes to the different combinations and concentrations of metals and other environmental variables present during the three field trials. Identification of differentially expressed proteins showed that proteins associated with cytoskeletal activity and stress responses were the most commonly affected biological functions in the Sydney Rock oyster. Overall, the data show that proteomics combined with multivariate analysis has the potential to link the effects of contaminants with biological consequences. - Highlights: ► Sydney Rock oyster haemolymph was analysed by proteomics after metal exposure in 3 field trials. ► 2-DE analysis was used to compare protein profiles between control and contaminated sites. ► Different protein expression profiles were revealed per field trial. ► Principal components analysis attributed profiles to different suites of metals and environmental variables per trial. ► The study highlights the need to do multiple field trials and to combine proteomic and enviro. data. - This study used proteomics to analyse impacts of metal contamination on Sydney Rock oyster (Saccostrea glomerata) haemolymph in multiple field trials.

Radiation breeding researches in gamma field. Results of researches

International Nuclear Information System (INIS)

Morishita, Toshikazu

2006-01-01

Abstract of radiation breeding researches and outline of gamma field in IRB (Institute of Radiation Breeding) are described. The gamma field is a circular field of 100 m radius with 88.8TBqCo-60 source at the center. The field is surrounded by a shielding dike of 8 m in height. The effects of gamma irradiation on the growing plants, mutant by gamma radiation and plant molecular biological researches using mutant varieties obtained by the gamma field are explained. For examples, Japanese pear, chrysanthemum, Cytisus, Eustoma grandiflorum, Manila grass, tea and rose are reported. The mutant varieties in the gamma field, nine mutant varieties of flower colors in chrysanthemum, evergreen mutant lines in Manila grass, selection of self-compatible mutants in tea plant, and the plants of the gamma field recently are shown. (S.Y.)

Magnetic resonance imaging/angiography and transcranial Doppler velocities in sickle cell anemia: results from the SWiTCH trial

OpenAIRE

Helton, Kathleen J.; Adams, Robert J.; Kesler, Karen L.; Lockhart, Alex; Aygun, Banu; Driscoll, Catherine; Heeney, Matthew M.; Jackson, Sherron M.; Krishnamurti, Lakshmanan; Miller, Scott T.; Sarnaik, Sharada A.; Schultz, William H.; Ware, Russell E.

2014-01-01

Children with SCA and stroke show severe parenchymal and vascular abnormalities that can be assessed using a vasculopathy grading scale.Results from the SWiTCH Trial support concerns about ineffectiveness of transfusion therapy in preventing cerebrovascular injury progression.

Study of lung density corrections in a clinical trial (RTOG 88-08)

International Nuclear Information System (INIS)

Orton, Colin G.; Chungbin, Suzanne; Klein, Eric E.; Gillin, Michael T.; Schultheiss, Timothy E.; Sause, William T.

1998-01-01

Purpose: To investigate the effect of lung density corrections on the dose delivered to lung cancer radiotherapy patients in a multi-institutional clinical trial, and to determine whether commonly available density-correction algorithms are sufficient to improve the accuracy and precision of dose calculation in the clinical trials setting. Methods and Materials: A benchmark problem was designed (and a corresponding phantom fabricated) to test density-correction algorithms under standard conditions for photon beams ranging from 60 Co to 24 MV. Point doses and isodose distributions submitted for a Phase III trial in regionally advanced, unresectable non-small-cell lung cancer (Radiation Therapy Oncology Group 88-08) were calculated with and without density correction. Tumor doses were analyzed for 322 patients and 1236 separate fields. Results: For the benchmark problem studied here, the overall correction factor for a four-field treatment varied significantly with energy, ranging from 1.14 ( 60 Co) to 1.05 (24 MV) for measured doses, or 1.17 ( 60 Co) to 1.05 (24 MV) for doses calculated by conventional density-correction algorithms. For the patient data, overall correction factors (calculated) ranged from 0.95 to 1.28, with a mean of 1.05 and distributional standard deviation of 0.05. The largest corrections were for lateral fields, with a mean correction factor of 1.11 and standard deviation of 0.08. Conclusions: Lung inhomogeneities can lead to significant variations in delivered dose between patients treated in a clinical trial. Existing density-correction algorithms are accurate enough to significantly reduce these variations

Field trial evaluation of the accumulation of omega-3 long chain polyunsaturated fatty acids in transgenic Camelina sativa: Making fish oil substitutes in plants

Directory of Open Access Journals (Sweden)

Sarah Usher

2015-12-01

Full Text Available The global consumption of fish oils currently exceeds one million tonnes, with the natural de novo source of these important fatty acids forming the base of marine foodwebs. Here we describe the first field-based evaluation of a terrestrial source of these essential nutrients, synthesised in the seeds of transgenic Camelina sativa plants via the heterologous reconstitution of the omega-3 long chain polyunsaturated fatty acid biosynthetic pathway. Our data demonstrate the robust nature of this novel trait, and the feasibility of making fish oils in genetically modified crops. Moreover, to our knowledge, this is the most complex example of plant genetic engineering to undergo environmental release and field evaluation. Keywords: Plant metabolic engineering, GM field trials, Omega-3 long chain polyunsaturated fatty acids, Fish oils, Camelina, Oilseeds

Clinical Trials

Medline Plus

Full Text Available ... these results are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding ... All types of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical ...

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 ...

Clinical Trials

Medline Plus

Full Text Available ... sponsored a trial of two different combinations of asthma treatments. The trial found that one of the ... much better than the other for moderate persistent asthma. The results provided important treatment information for doctors ...

Contamination control and revegetation (Field trials)

International Nuclear Information System (INIS)

Robison, William L.; Stone, Earl L.

1986-01-01

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

An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

Science.gov (United States)

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

2013-11-01

To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov 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 ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from ClinicalTrials.gov 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 ClinicalTrials.gov 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 ClinicalTrials.gov 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 ClinicalTrials.gov 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.

Results after ten years of field testing low-level radioactive waste forms using lysimeters

International Nuclear Information System (INIS)

McConnell, J.W. Jr.; Rogers, R.D.; Jastrow, J.D.; Sanford, W.E.; Larsen, I.L.; Sullivan, T.M.

1995-01-01

The Field Lysimeter Investigations: Low-Level Waste Data Base Development Program is obtaining information on the performance of radioactive waste forms. Ion-exchange resins from a commercial nuclear power station were solidified into waste forms using portland cement and vinyl esterstyrene. These waste forms are being tested to: (a) obtain information on performance of waste forms in typical disposal environments, (b) compare field results with bench leach studies, (c) develop a low-level waste data base for use in performance assessment source term calculations, and (d) apply the DUST computer code to compare predicted cumulative release to actual field data. The program, funded by the Nuclear Regulatory Commission (NRC), includes observed radionuclide releases from waste forms in field lysimeters. The purpose of this paper is to present the experimental results of two lysimeter arrays over 10 years of operation, and to compare those results to bench test results and to DUST code predicted releases. Further analysis of soil cores taken to define the observed upward migration of radionuclides in one lysimeter is also presented

Review of WAG Field Experience

DEFF Research Database (Denmark)

Christensen, Jes Reimer; Stenby, Erling Halfdan; Skauge, A.

2001-01-01

well spacing is in the order of 1000 m. For the fields reviewed, a common trend for the successful injections is an increased oil recovery in the range of 5 to 10% of the oil initially in place (OIIP). Very few field trials have been reported as unsuccessful, but operational problems are often noted...

A randomised comparison of radical radiotherapy with or without chemotherapy for patients with non-small cell lung cancer: Results from the Big Lung Trial

International Nuclear Information System (INIS)

Fairlamb, David; Milroy, Robert; Gower, Nicole; Parmar, Mahesh; Peake, Michael; Rudd, Robin; Souhami, Robert; Spiro, Stephen; Stephens, Richard; Waller, David

2005-01-01

Background: A meta-analysis of trials comparing primary treatment with or without chemotherapy for patients with non-small cell lung cancer published in 1995 suggested a survival benefit for cisplatin-based chemotherapy in each of the primary treatment settings studied, but it included many small trials, and trials with differing eligibility criteria and chemotherapy regimens. Methods: The Big Lung Trial was a large pragmatic trial designed to confirm the survival benefits seen in the meta-analysis, and this paper reports the findings in the radical radiotherapy setting. The trial closed before the required sample size was achieved due to slow accrual, with a total of 288 patients randomised to receive radical radiotherapy alone (146 patients) or sequential radical radiotherapy and cisplatin-based chemotherapy (142 patients). Results: There was no evidence that patients allocated sequential chemotherapy and radical radiotherapy had a better survival than those allocated radical radiotherapy alone, HR 1.07 (95% CI 0.84-1.38, P=0.57), median survival 13.0 months for the sequential group and 13.2 for the radical radiotherapy alone group. In addition, exploratory analyses could not identify any subgroup that might benefit more or less from chemotherapy. Conclusions: Despite not suggesting a survival benefit for the sequential addition of chemotherapy to radical radiotherapy, possibly because of the relatively small sample size and consequently wide confidence intervals, the results can still be regarded as consistent with the meta-analysis, and other similarly designed recently published large trials. Combining all these results suggests there may be a small median survival benefit with chemotherapy of between 2 and 8 weeks

Extended Wearing Trial of Trifield Lens Device for “Tunnel Vision”

Science.gov (United States)

Woods, Russell L.; Giorgi, Robert G.; Berson, Eliot L.; Peli, Eli

2009-01-01

Severe visual field constriction (tunnel vision) impairs the ability to navigate and walk safely. We evaluated Trifield glasses as a mobility rehabilitation device for tunnel vision in an extended wearing trial. Twelve patients with tunnel vision (5 to 22 degrees wide) due to retinitis pigmentosa or choroideremia participated in the 5-visit wearing trial. To expand the horizontal visual field, one spectacle lens was fitted with two apex-to-apex prisms that vertically bisected the pupil on primary gaze. This provides visual field expansion at the expense of visual confusion (two objects with the same visual direction). Patients were asked to wear these spectacles as much as possible for the duration of the wearing trial (median 8, range 6 to 60, weeks). Clinical success (continued wear, indicating perceived overall benefit), visual field expansion, perceived direction and perceived visual ability were measured. Of 12 patients, 9 chose to continue wearing the Trifield glasses at the end of the wearing trial. Of those 9 patients, at long-term follow-up (35 to 78 weeks), 3 reported still wearing the Trifield glasses. Visual field expansion (median 18, range 9 to 38, degrees) was demonstrated for all patients. No patient demonstrated adaptation to the change in visual direction produced by the Trifield glasses (prisms). For difficulty with obstacles, some differences between successful and non-successful wearers were found. Trifield glasses provided reported benefits in obstacle avoidance to 7 of the 12 patients completing the wearing trial. Crowded environments were particularly difficult for most wearers. Possible reasons for long-term discontinuation and lack of adaptation to perceived direction are discussed. PMID:20444130

X-Ray Processing of ChaMPlane Fields: Methods and Initial Results for Selected Anti-Galactic Center Fields

Science.gov (United States)

Hong, JaeSub; van den Berg, Maureen; Schlegel, Eric M.; Grindlay, Jonathan E.; Koenig, Xavier; Laycock, Silas; Zhao, Ping

2005-12-01

We describe the X-ray analysis procedure of the ongoing Chandra Multiwavelength Plane (ChaMPlane) Survey and report the initial results from the analysis of 15 selected anti-Galactic center observations (90degusing custom-developed analysis tools appropriate for Galactic sources but also of general use: optimum photometry in crowded fields using advanced techniques for overlapping sources, rigorous astrometry and 95% error circles for combining X-ray images or matching to optical/IR images, and application of quantile analysis for spectral analysis of faint sources. We apply these techniques to 15 anti-Galactic center observations (of 14 distinct fields), in which we have detected 921 X-ray point sources. We present logN-logS distributions and quantile analysis to show that in the hard band (2-8 keV) active galactic nuclei dominate the sources. Complete analysis of all ChaMPlane anti-Galactic center fields will be given in a subsequent paper, followed by papers on sources in the Galactic center and bulge regions.

Open Access Platforms in Spinal Cord Injury: Existing Clinical Trial Data to Predict and Improve Outcomes.

Science.gov (United States)

Kramer, John L K; Geisler, Fred; Ramer, Leanne; Plunet, Ward; Cragg, Jacquelyn J

2017-05-01

Recovery from acute spinal cord injury (SCI) is characterized by extensive heterogeneity, resulting in uncertain prognosis. Reliable prediction of recovery in the acute phase benefits patients and their families directly, as well as improves the likelihood of detecting efficacy in clinical trials. This issue of heterogeneity is not unique to SCI. In fields such as traumatic brain injury, Parkinson's disease, and amyotrophic lateral sclerosis, one approach to understand variability in recovery has been to make clinical trial data widely available to the greater research community. We contend that the SCI community should adopt a similar approach in providing open access clinical trial data.

Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)†.

Science.gov (United States)

Bellera, C A; Penel, N; Ouali, M; Bonvalot, S; Casali, P G; Nielsen, O S; Delannes, M; Litière, S; Bonnetain, F; Dabakuyo, T S; Benjamin, R S; Blay, J-Y; Bui, B N; Collin, F; Delaney, T F; Duffaud, F; Filleron, T; Fiore, M; Gelderblom, H; George, S; Grimer, R; Grosclaude, P; Gronchi, A; Haas, R; Hohenberger, P; Issels, R; Italiano, A; Jooste, V; Krarup-Hansen, A; Le Péchoux, C; Mussi, C; Oberlin, O; Patel, S; Piperno-Neumann, S; Raut, C; Ray-Coquard, I; Rutkowski, P; Schuetze, S; Sleijfer, S; Stoeckle, E; Van Glabbeke, M; Woll, P; Gourgou-Bourgade, S; Mathoulin-Pélissier, S

2015-05-01

The use of potential surrogate end points for overall survival, such as disease-free survival (DFS) or time-to-treatment failure (TTF) is increasingly common in randomized controlled trials (RCTs) in cancer. However, the definition of time-to-event (TTE) end points is rarely precise and lacks uniformity across trials. End point definition can impact trial results by affecting estimation of treatment effect and statistical power. The DATECAN initiative (Definition for the Assessment of Time-to-event End points in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for RCT in sarcomas and gastrointestinal stromal tumors (GIST). We first carried out a literature review to identify TTE end points (primary or secondary) reported in publications of RCT. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points. Recommendations were developed through a validated consensus method formalizing the degree of agreement among experts. Recommended guidelines for the definition of TTE end points commonly used in RCT for sarcomas and GIST are provided for adjuvant and metastatic settings, including DFS, TTF, time to progression and others. Use of standardized definitions should facilitate comparison of trials' results, and improve the quality of trial design and reporting. These guidelines could be of particular interest to research scientists involved in the design, conduct, reporting or assessment of RCT such as investigators, statisticians, reviewers, editors or regulatory authorities. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India.

Science.gov (United States)

Gass, Jonathon D; Misra, Anamika; Yadav, Mahendra Nath Singh; Sana, Fatima; Singh, Chetna; Mankar, Anup; Neal, Brandon J; Fisher-Bowman, Jennifer; Maisonneuve, Jenny; Delaney, Megan Marx; Kumar, Krishan; Singh, Vinay Pratap; Sharma, Narender; Gawande, Atul; Semrau, Katherine; Hirschhorn, Lisa R

2017-09-07

There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In the trial, over 6300 deliveries were observed and over 153,000 mother-baby pairs across 120 study sites were followed to assess health outcomes. We designed and implemented a robust and integrated DQA system to sustain high-quality data throughout the trial. We designed the Data Quality Monitoring and Improvement System (DQMIS) to reinforce six dimensions of data quality: accuracy, reliability, timeliness, completeness, precision, and integrity. The DQMIS was comprised of five functional components: 1) a monitoring and evaluation team to support the system; 2) a DQA protocol, including data collection audits and targets, rapid data feedback, and supportive supervision; 3) training; 4) standard operating procedures for data collection; and 5) an electronic data collection and reporting system. Routine audits by supervisors included double data entry, simultaneous delivery observations, and review of recorded calls to patients. Data feedback reports identified errors automatically, facilitating supportive supervision through a continuous quality improvement model. The five functional components of the DQMIS successfully reinforced data reliability, timeliness, completeness, precision, and integrity. The DQMIS also resulted in 98.33% accuracy across all data collection activities in the trial. All data collection activities demonstrated improvement in accuracy throughout implementation. Data collectors demonstrated a statistically significant (p = 0.0004) increase in accuracy throughout

Field Screening of Waterlogging Tolerance in Spring Wheat and Spring Barley

Directory of Open Access Journals (Sweden)

Tove Kristina Sundgren

2018-03-01

Full Text Available Improved waterlogging tolerance of wheat and barley varieties may alleviate yield constraints caused by heavy or long-lasting precipitation. The waterlogging tolerance of 181 wheat and 210 barley genotypes was investigated in field trials between 2013 and 2014. A subset of wheat genotypes were selected for yield trials in 2015 and 2016. Our aim was to: (1 characterize the waterlogging tolerance of genotypes with importance for Norwegian wheat and barley breeding, and (2 identify which phenotypic traits that most accurately determine the waterlogging tolerance of wheat in our field trials. Waterlogging tolerance was determined by principal component analysis (PCA where best linear unbiased predictors (BLUPs of the traits chlorosis, relative plant height, heading delay, relative spike number, relative biomass and an overall condition score were used as input variables. Six wheat and five barley genotypes were identified as consistently more tolerant in 2013 and 2014. This included the waterlogging tolerant CIMMYT line CETA/Ae. tauschii (895. Chlorosis and the overall condition score were the traits that best explained the yield response of the genotypes selected for the yield trials. Our results show that early stress symptoms did not necessarily reflect the ability to recover post treatment. Thus, records from full crop cycles appear as fundamental when screening populations with unknown tolerance properties.

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

Directory of Open Access Journals (Sweden)

Izabela Michalak

2016-10-01

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

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

Science.gov (United States)

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

2016-01-01

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

Meteorology and lidar data from the URAHFREP field trials

DEFF Research Database (Denmark)

Ott, Søren; Ejsing Jørgensen, Hans

2002-01-01

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

Scintimammography with technetium-99m methoxyisobutylisonitrile: results of a prospective European multicentre trial

Energy Technology Data Exchange (ETDEWEB)

Palmedo, H.; Biersack, H.J. [Bonn Univ. (Germany). Dept. of Nucl. Med.; Lastoria, S. [Department of Nuclear Medicine, National Cancer Institute of Naples (Italy); Maublant, J. [Department of Nuclear Medicine, Centre Jean Perrin in Clermont Ferrand (France); Prats, E. [Department of Nuclear Medicine, University Hospital of Zaragoza (Spain); Stegner, H.E. [Department of Gynecology, University of Hamburg (Germany); Bourgeois, P. [Department of Nuclear Medicine, Hospital St. Pierre in Bruxelles (Belgium); Hustinx, R. [Department of Nuclear Medicine, University Hospital in Liege (Belgium); Hilson, A.J.W. [Department of Nuclear Medicine, NHS Trust Hospital in London (United Kingdom); Bischof-Delaloye, A. [Department of Nuclear Medicine, University of Lausanne (Switzerland)

1998-04-01

The aim of the trial was to determine the diagnostic accuracy of scintimmammography with technetium-99m methoxyisobutylisonitrile ({sup 99m}Tc-MIBI) in the detection of primary breast cancer and to verify its clinical usefulness. A total of 246 patients with a suspicious breast mass or positive mammogram were included in this prospective European multicentre trial. At 5 min and 60 min (optional) p.i. two lateral prone images were acquired for 10 min each; 30 min p.i. one anterior image was acquired for 10 min. There were 253 lesions (195 palpable and 58 non-palpable), in respect of which histology revealed 165 cancers and 88 benign lesions. Institutional and blinded read results were correlated to core laboratory histopathology results obtained during excisional biopsy. Diagnostic accuracy for the detection of breast cancer was calculated per lesion. The overall sensitivity and specificity of blinded read scintimammography were 71% and 69%, respectively. For palpable lesions, the sensitivity of blinded read and institutional read scintimammography was 83% and 91%, respectively. Sensitivity was not dependent on the density of the breast tissue. Invasive ductal and invasive lobular cancers showed similar sensitivity. The sensitivity and specificity of mammography were 91% and 42%, respectively, and did not depend on the tumour size. In 60% of false-negative mammograms, {sup 99m}Tc-MIBI was able to diagnose malignancy (true-positive). High-quality imaging with {sup 99m}Tc-MIBI has a high diagnostic accuracy for the detection of primary breast cancer. Used as a complementary method, scintimammography with {sup 99m}Tc-MIBI can help to diagnose breast cancer at an earlier stage in patients with dense breasts. (orig.) With 6 figs., 12 tabs., 55 refs.

Olsalazine is contraindicated during pelvic radiation therapy: results of a double-blind, randomized clinical trial

International Nuclear Information System (INIS)

Martenson, James A.; Hyland, Glenn; Moertel, Charles G.; Mailliard, James A.; O'Fallon, Judith R.; Collins, Roger T.; Morton, Roscoe F.; Tewfik, Hamed H.; Moore, Randy L.; Frank, Albert R.; Urias, Rodolfo E.; Deming, Richard L.

1996-01-01

Purpose: A randomized clinical trial from Great Britain suggested a possible beneficial effect of acetylsalicylate in the prevention of radiation-induced bowel toxicity. Olsalazine is an orally administered drug designed to deliver 5-aminosalicylate to the large bowel with minimal systemic absorption. A randomized clinical trial was undertaken to assess the effectiveness of olsalazine in preventing acute diarrhea in patients receiving pelvic radiation therapy. Methods and Materials: Patients receiving pelvic radiation therapy were randomized, in double-blind fashion, to olsalazine 250 mg, two capsules twice daily, or an identical appearing placebo, two capsules twice daily. Patients were then evaluated weekly during radiation therapy for the primary study endpoint, diarrhea, as well as rectal bleeding, abdominal cramping, and tenesmus. Results: The study was closed early, after entry of 58 evaluable patients, when a preliminary analysis showed excessive diarrhea in patients randomized to olsalazine. The incidence and severity of diarrhea were worse in patients randomized to olsalazine (p 0.0036). Sixty percent of the patients randomized to olsalazine experienced Grade 3 or 4 diarrhea compared to only 14% randomized to placebo. There was also a trend toward higher incidence and greater severity of abdominal cramping in patients who were randomized to olsalazine (p = 0.084). Conclusion: Administration of olsalazine during pelvic radiation therapy resulted in an increased incidence and severity of diarrhea. Olsalazine is contraindicated in patients receiving pelvic radiation therapy

FIVE-YEAR RESULTS OF ADJUVANT RADIOTHER

Science.gov (United States)

Osa, Etin-Osa O.; DeWyngaert, Keith; Roses, Daniel; Speyer, James; Guth, Amber; Axelrod, Deborah; Kerimian, Maria Fenton; Goldberg, Judith D.; Formenti, Silvia C.

2015-01-01

Purpose/Objective A technique of prone breast radiotherapy delivered by a regimen of accelerated intensity modulated radiation therapy (IMRT) with a concurrent boost to the tumor bed, was developed at our institution. We report the five year results of this approach. Methods and Materials Between 2003–2006, 404 patients with Stage I–II breast cancer were prospectively enrolled into two consecutive protocols, institutional trials 03–30 and 05–181, that used the same regimen of 40.5Gy/15 fractions delivered to the index breast over 3 weeks, with a concomitant daily boost to the tumor bed of 0.5Gy (total dose=48Gy). All patients were treated after segmental mastectomy, had negative margins, and nodal assessment. Patients were set up prone: only if lung or heart volumes were in the field was a supine set-up attempted, and chosen if found to better spare these organs. Results 92% of patients were treated prone, 8% supine. 72% had stage I, 28% stage II invasive breast cancer. In-field lung volume ranged from 0 –228.27cc, mean: 19.65cc. In-field heart volume for left breast cancer patients ranged from 0–21.24cc, mean: 1.59cc. There was no heart in the field for right breast cancer patients. At a median follow-up of five years, the five-year cumulative incidence of isolated ipsilateral breast tumor recurrence was 0.82% (95% CI: 0.65–1.04). The five-year cumulative incidence of regional recurrence was 0.53% (95% CI:0.41–0.69) and the five-year overall cumulative death rate was 1.28% (95% CI: 0.48–3.38). 82% (95% CI: 77–85) of patients judged their final cosmetic result as excellent/good. Conclusions Prone accelerated IMRT with a concomitant boost results in excellent local control, optimal sparing of heart and lung, with good cosmesis. RTOG 10–05, a phase III, multi-institutional, randomized trial is ongoing and is evaluating the equivalence of a similar dose and fractionation approach to standard six weeks radiotherapy with a sequential boost. PMID

Positive outcomes influence the rate and time to publication, but not the impact factor of publications of clinical trial results.

Directory of Open Access Journals (Sweden)

Pilar Suñé

Full Text Available OBJECTIVES: Publication bias may affect the validity of evidence based medical decisions. The aim of this study is to assess whether research outcomes affect the dissemination of clinical trial findings, in terms of rate, time to publication, and impact factor of journal publications. METHODS AND FINDINGS: All drug-evaluating clinical trials submitted to and approved by a general hospital ethics committee between 1997 and 2004 were prospectively followed to analyze their fate and publication. Published articles were identified by searching Pubmed and other electronic databases. Clinical study final reports submitted to the ethics committee, final reports synopses available online and meeting abstracts were also considered as sources of study results. Study outcomes were classified as positive (when statistical significance favoring experimental drug was achieved, negative (when no statistical significance was achieved or it favored control drug and descriptive (for non-controlled studies. Time to publication was defined as time from study closure to publication. A survival analysis was performed using a Cox regression model to analyze time to publication. Journal impact factors of identified publications were recorded. Publication rate was 48·4% (380/785. Study results were identified for 68·9% of all completed clinical trials (541/785. Publication rate was 84·9% (180/212 for studies with results classified as positive and 68·9% (128/186 for studies with results classified as negative (p<0·001. Median time to publication was 2·09 years (IC95 1·61-2·56 for studies with results classified as positive and 3·21 years (IC95 2·69-3·70 for studies with results classified as negative (hazard ratio 1·99 (IC95 1·55-2·55. No differences were found in publication impact factor between positive (median 6·308, interquartile range: 3·141-28·409 and negative result studies (median 8·266, interquartile range: 4·135-17·157. CONCLUSIONS

Genomic Selection in Multi-environment Crop Trials.

Science.gov (United States)

Oakey, Helena; Cullis, Brian; Thompson, Robin; Comadran, Jordi; Halpin, Claire; Waugh, Robbie

2016-05-03

Genomic selection in crop breeding introduces modeling challenges not found in animal studies. These include the need to accommodate replicate plants for each line, consider spatial variation in field trials, address line by environment interactions, and capture nonadditive effects. Here, we propose a flexible single-stage genomic selection approach that resolves these issues. Our linear mixed model incorporates spatial variation through environment-specific terms, and also randomization-based design terms. It considers marker, and marker by environment interactions using ridge regression best linear unbiased prediction to extend genomic selection to multiple environments. Since the approach uses the raw data from line replicates, the line genetic variation is partitioned into marker and nonmarker residual genetic variation (i.e., additive and nonadditive effects). This results in a more precise estimate of marker genetic effects. Using barley height data from trials, in 2 different years, of up to 477 cultivars, we demonstrate that our new genomic selection model improves predictions compared to current models. Analyzing single trials revealed improvements in predictive ability of up to 5.7%. For the multiple environment trial (MET) model, combining both year trials improved predictive ability up to 11.4% compared to a single environment analysis. Benefits were significant even when fewer markers were used. Compared to a single-year standard model run with 3490 markers, our partitioned MET model achieved the same predictive ability using between 500 and 1000 markers depending on the trial. Our approach can be used to increase accuracy and confidence in the selection of the best lines for breeding and/or, to reduce costs by using fewer markers. Copyright © 2016 Oakey et al.

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

Science.gov (United States)

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

2010-01-01

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

Asian Americans and Cancer Clinical Trials: A Mixed-Methods Approach to Understanding Awareness and Experience

Science.gov (United States)

Paterniti, Debora A.; Chen, Moon S.; Chiechi, Christine; Beckett, Laurel A.; Horan, Nora; Turrell, Corinne; Smith, Ligaya; Morain, Claudia; Montell, Lisa; Gonzalez, Jose Luis; Davis, Sharon; Lara, Primo N.

2006-01-01

Cancer clinical trials have been based on low accrual rates. Barriers to recruitment of minority populations affect the generalizability and impact of trial findings for those populations. The authors undertook a mixed-methods approach to understanding levels of awareness and experiences with cancer clinical trials. A survey was administered to new cancer patients and their caretakers (family, close friends, or other social support) at outpatient oncology clinics. Field observations of the trial accrual process also were conducted by employing the grounded theory approach in qualitative methods. Comparison of survey results for Asian-American respondents and non-Asian respondents indicated that Asians were less likely to have heard the term “clinical trial” and were more likely to define a clinical trial as “an experiment” or “a test procedure in a clinic” than non-Asians. Asians were more likely to have employer-based insurance and to report understanding issues related to cost reimbursement. Asians were less likely to have been involved in or to know someone in a trial and reported less willingness than white respondents to consider trial participation. Qualitative observations suggested that Asians who presented for a potential trial were interested in the availability of a novel cancer therapy but were not eligible for available trials. Multiple strategies will be necessary to enhance awareness of and experience with accrual to cancer clinical trials for Asians, including richer understanding and increased involvement of Asians in cancer clinical trials and greater attention to the location and diversity of the Asian population in structuring study centers and evaluating trial results. PMID:16247795

First satellite mobile communication trials using BLQS-CDMA

Science.gov (United States)

Luzdemateo, Maria; Johns, Simon; Dothey, Michel; Vanhimbeeck, Carl; Deman, Ivan; Wery, Bruno

1993-01-01

In this paper, technical results obtained in the first MSBN Land mobile technical trial are reported. MSBN (Mobile Satellite Business Network) is a new program undertaken by the European Space Agency (ESA) to promote mobile satellite communication in Europe, in particular voice capability. The first phase of the MSBN system implementation plan is an experimental phase. Its purpose is to evaluate through field experiments the performance of the MSBN system prior to finalization of its specifications. Particularly, the objective is to verify in the field and possibly improve the performance of the novel satellite access technique BLQS-CDMA (Band Limited Quasi-Synchronous-Code Division Multiple Access), which is proposed as baseline for the MSBN.

Brief Report: HIV Drug Resistance in Adults Failing Early Antiretroviral Treatment: Results From the HIV Prevention Trials Network 052 Trial.

Science.gov (United States)

Fogel, Jessica M; Hudelson, Sarah E; Ou, San-San; Hart, Stephen; Wallis, Carole; Morgado, Mariza G; Saravanan, Shanmugam; Tripathy, Srikanth; Hovind, Laura; Piwowar-Manning, Estelle; Sabin, Devin; McCauley, Marybeth; Gamble, Theresa; Zhang, Xinyi C; Eron, Joseph J; Gallant, Joel E; Kumwenda, Johnstone; Makhema, Joseph; Kumarasamy, Nagalingeswaran; Chariyalertsak, Suwat; Hakim, James; Badal-Faesen, Sharlaa; Akelo, Victor; Hosseinipour, Mina C; Santos, Breno R; Godbole, Sheela V; Pilotto, Jose H; Grinsztejn, Beatriz; Panchia, Ravindre; Mayer, Kenneth H; Chen, Ying Q; Cohen, Myron S; Eshleman, Susan H

2016-07-01

Early initiation of antiretroviral treatment (ART) reduces HIV transmission and has health benefits. HIV drug resistance can limit treatment options and compromise use of ART for HIV prevention. We evaluated drug resistance in 85 participants in the HIV Prevention Trials Network 052 trial who started ART at CD4 counts of 350-550 cells per cubic millimeter and failed ART by May 2011; 8.2% had baseline resistance and 35.3% had resistance at ART failure. High baseline viral load and less education were associated with emergence of resistance at ART failure. Resistance at ART failure was observed in 7 of 8 (87.5%) participants who started ART at lower CD4 cell counts.

Risk of discontinuation of Advanced Therapy Medicinal Products clinical trials.

Science.gov (United States)

Hanna, Eve; Rémuzat, Cecile; Auquier, Pascal; Toumi, Mondher

2016-01-01

Advanced therapy medicinal products (ATMPs) constitute a class of innovative products that encompasses gene therapy, somatic cell therapy, and tissue-engineered products (TEP). There is an increased investment of commercial and non-commercial sponsors in this field and a growing number of ATMPs randomized clinical trials (RCT) and patients enrolled in such trials. RCT generate data to prove the efficacy of a new therapy, but the discontinuation of RCTs wastes scarce resources. Our objective is to identify the number and characteristics of discontinued ATMPs trials in order to evaluate the rate of discontinuation. We searched for ATMPs trials conducted between 1999 to June 2015 using three databases, which are Clinicaltrials.gov, the International Clinical Trials Registry Platform (ICTRP), and the EU Drug Regulating Authorities Clinical Trials (EudraCT). We selected the ATMPs trials after elimination of the duplicates. We identified the disease areas and the sponsors as commercial or non-commercial organizations. We classified ATMPs by type and trial status, that is, ongoing, completed, terminated, discontinued, and prematurely ended. Then, we calculated the rate of discontinuation. Between 1999 and June 2015, 143 withdrawn, terminated, or prematurely ended ATMPs clinical trials were identified. Between 1999 and June 2013, 474 ongoing and completed clinical trials were identified. Therefore, the rate of discontinuation of ATMPs trials is 23.18%, similar to that for non-ATMPs drugs in development. The probability of discontinuation is, respectively, 27.35, 16.28, and 16.34% for cell therapies, gene therapies, and TEP. The highest discontinuation rate is for oncology (43%), followed by cardiology (19.2%). It is almost the same for commercial and non-commercial sponsors; therefore, the discontinuation reason may not be financially driven. No failure risk rate per development phase is available for ATMPs. The discontinuation rate may prove helpful when assessing the

Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial.

Science.gov (United States)

Marsen, Tobias A; Beer, Justinus; Mann, Helmut

2017-02-01

Protein-energy wasting (PEW) is increasingly becoming a clinical problem in maintenance hemodialysis patients and guidelines call for nutritional interventions. Serum prealbumin (transthyretin) represents a critical nutritional marker positively correlated with patient survival and negatively correlated with morbidity. Nutritional counseling, oral supplementation as well as intradialytic parenteral nutrition (IDPN) are recommended to fight PEW, however clinical trials on their use are scarce. We conducted a prospective, multicenter, randomized, open-label, controlled, parallel-group Phase IV clinical trial in 107 maintenance hemodialysis patients suffering from PEW to assess the impact of IDPN on prealbumin and other biochemical and clinical parameters reflecting nutritional status. Patients randomized to the intervention group received standardized nutritional counseling plus IDPN three times weekly over 16 weeks followed by a treatment-free period of 12 weeks. The control group received standardized nutritional counseling only. Main trial inclusion criteria included moderate to severe malnutrition (SGA score B or C), maintenance hemodialysis therapy (3 times per week) for more than six months, and presence of two out of the following three criteria: albumin 30 mg/L at week 16 (48.7% vs. 31.8%). Prealbumin response to IDPN therapy was more prominent in patients suffering from moderate malnutrition (SGA score B) compared to patients with severe malnutrition (SGA score C). The results of this trial demonstrate for the first time that IDPN therapy, given three times weekly in a 16-week short-term intervention, results in a statistically significant and clinically relevant increase in mean serum prealbumin, a surrogate marker for outcome and survival in hemodialysis patients suffering from PEW, and is superior to nutritional counseling. Clinical trial registry:www.clinicaltrials.gov (NCT00501956). Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights

Doxycycline in the treatment of respiratory tract infections. Results of a pan-European multi-centre trial.

Science.gov (United States)

Pestel, M

1975-01-01

In the winter of 1973-4, general practitioners from seven European countries took part in a multi-centre trial of doxycycline in the treatment of infections of the respiratory tract. The carefully designed protocol was observed by all participants. A total of 1,747 patients were admitted to the trial; their ages ranged from 6 years to over 80. The commonest diagnoses (50%) were acute bronchitis and acute exacerbations of chronic bronchitis. On the recommended dosage of 200 mg doxycycline on the first day, followed by 100 mg daily thereafter (though 200 mg could be continued daily in severe cases), 87% of patients achieved good or very good results. Both subjective (pain) and objective (sputum volume and viscosity, temperature, cough) measures showed rapid improvement, usually by the third to fifth days. Side-effects were minimal and mainly gastrointestinal and caused only 4 patients to discontinue treatment. Overall, doxycycline proved its effectiveness and rapidity of action.

Botulinum toxin to improve results in cleft lip repair: a double-blinded, randomized, vehicle-controlled clinical trial.

Directory of Open Access Journals (Sweden)

Chun-Shin Chang

Full Text Available Most patients with facial scarring would value even a slight improvement in scar quality. Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing. The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds.In this double-blinded, randomized, vehicle-controlled, prospective clinical trial, 60 consecutive consenting adults undergoing cleft lip scar revision (CLSR surgery between July 2010 and March 2012 were randomized to receive botulinum toxin A (n = 30 or vehicle (normal saline; n = 30 injections into the subjacent orbicularis oris muscle immediately after wound closure. Scars were independently assessed at 6-months follow-up in blinded fashion using: Vancouver Scar Scale (VSS, Visual Analogue Scale (VAS and photographic plus ultrasound measurements of scar widths.58 patients completed the trial. All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group.Quality of surgical upper lip scars, which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle, is significantly improved by its temporary paralysis during wound healing.ClinicalTrials.gov NCT01429402.

1992-93 Results of geomorphological and field studies Volcanic Studies Program, Yucca Mountain Project

International Nuclear Information System (INIS)

Wells, S.G.

1993-10-01

Field mapping and stratigraphic studies were completed of the Black Tank volcanic center, which represents the southwestern most eruptive center in the Cima volcanic field of California. The results of this mapping are presented. Contacts between volcanic units and geomorphic features were field checked, incorporating data from eight field trenches as well as several exposures along Black Tank Wash. Within each of the eight trenches, logs were measured and stratigraphic sections were described. These data indicate that three, temporally separate volcanic eruptions occurred at the Black Tank center. The field evidence for significant time breaks between each stratigraphic unit is the presence of soil and pavement-bounded unconformities

Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: Results of a survey

Directory of Open Access Journals (Sweden)

Vale Claire L

2012-01-01

Full Text Available Abstract Background We aimed to establish levels of consumer involvement in randomised controlled trials (RCTs, meta-analyses and other studies carried out by the UK Medical Research Council (MRC Clinical Trials Unit across the range of research programs, predominantly in cancer and HIV. Methods Staff responsible for studies that were included in a Unit Progress Report (MRC CTU, April 2009 were asked to complete a semi-structured questionnaire survey regarding consumer involvement. This was defined as active involvement of consumers as partners in the research process and not as subjects of that research. The electronic questionnaires combined open and closed questions, intended to capture quantitative and qualitative information on whether studies had involved consumers; types of activities undertaken; recruitment and support; advantages and disadvantages of involvement and its perceived impact on aspects of the research. Results Between October 2009 and April 2010, 138 completed questionnaires (86% were returned. Studies had been conducted over a 20 year period from 1989, and around half were in cancer; 30% in HIV and 20% were in other disease areas including arthritis, tuberculosis and blood transfusion medicine. Forty-three studies (31% had some consumer involvement, most commonly as members of trial management groups (TMG [88%]. A number of positive impacts on both the research and the researcher were identified. Researchers generally felt involvement was worthwhile and some felt that consumer involvement had improved the credibility of the research. Benefits in design and quality, trial recruitment, dissemination and decision making were also perceived. Researchers felt they learned from consumer involvement, albeit that there were some barriers. Conclusions Whilst most researchers identified benefits of involving consumers, most of studies included in the survey had no involvement. Information from this survey will inform the development

Does transfusion improve the outcome for HNSCC patients treated with radiotherapy? - results from the randomized DAHANCA 5 and 7 trials

DEFF Research Database (Denmark)

Hoff, Camilla; Lassen, Pernille; Eriksen, Jesper Grau

2011-01-01

Patients with head and neck squamous cell carcinoma (HNSCC) and a low level of hemoglobin often have a poor response to radiation that may be related to hypoxia-induced radioresistance. We have previously published the importance of hemoglobin level and the effect of transfusion by the results fr...... the randomized DAHANCA 5 trial, including 414 patients in the analysis. Aim of the current analysis was to gain additional power by adding patients from the continued subrandomization in the DAHANCA 7 trial, now including a total of almost 1200 patients....

How Can the Evidence from Global Large-scale Clinical Trials for Cardiovascular Diseases be Improved?

Science.gov (United States)

Sawata, Hiroshi; Tsutani, Kiichiro

2011-06-29

Clinical investigations are important for obtaining evidence to improve medical treatment. Large-scale clinical trials with thousands of participants are particularly important for this purpose in cardiovascular diseases. Conducting large-scale clinical trials entails high research costs. This study sought to investigate global trends in large-scale clinical trials in cardiovascular diseases. We searched for trials using clinicaltrials.gov (URL: http://www.clinicaltrials.gov/) using the key words 'cardio' and 'event' in all fields on 10 April, 2010. We then selected trials with 300 or more participants examining cardiovascular diseases. The search revealed 344 trials that met our criteria. Of 344 trials, 71% were randomized controlled trials, 15% involved more than 10,000 participants, and 59% were funded by industry. In RCTs whose results were disclosed, 55% of industry-funded trials and 25% of non-industry funded trials reported statistically significant superiority over control (p = 0.012, 2-sided Fisher's exact test). Our findings highlighted concerns regarding potential bias related to funding sources, and that researchers should be aware of the importance of trial information disclosures and conflicts of interest. We should keep considering management and training regarding information disclosures and conflicts of interest for researchers. This could lead to better clinical evidence and further improvements in the development of medical treatment worldwide.

Ten years later: Evaluation of the effectiveness of 12.5% amitraz against a field population of Rhipicephalus (Boophilus) microplus using field studies, artificial infestation (Stall tests) and adult immersion tests.

Science.gov (United States)

Maciel, Willian Giquelin; Lopes, Welber Daniel Zanetti; Cruz, Breno Cayeiro; Gomes, Lucas Vinicius Costa; Teixeira, Weslen Fabrício Pires; Buzzulini, Carolina; Bichuette, Murilo Abud; Campos, Gabriel Pimentel; Felippelli, Gustavo; Soares, Vando Edésio; de Oliveira, Gilson Pereira; da Costa, Alvimar José

2015-12-15

Using field trials, artificial infestations (Stall tests) and in vitro adult immersion tests, the present study evaluated the acaricidal efficacy of 12.5% amitraz administered via whole body spraying against a Rhipicephalus (Boophilus) microplus population that did not have any contact with chemical products belonging to this acaricide family for 10 years (approximately 40 generations). Two natural infestation trials, two artificial infestation trials (Stall tests) and two adult immersion tests were performed in two different stages in 2005 and 2015. Between 2002 and 2015, the bovine herd of this property was formed by approximately 450 animals from the Simmental breed that were divided into nine paddocks formed by Cynodon dactylon (L.) Pers. For the natural infestation experiments in 2005 and 2015, we selected nearly 70 animals naturally infested with ticks from the same herd that belonged to the "São Paulo" farm located in São José do Rio Pardo, São Paulo, Brazil. Field studies were performed in the same paddock (9). To evaluate anti-R. (B.) microplus activity in the artificially infested cattle (Stall tests) and adult immersion tests, two experiments of each methodology were performed at CPPAR (the Center of Research in Animal Health located on the FCAV/UNESP campus in Jaboticabal, São Paulo, Brazil) in 2005 and 2015. R. (B.) microplus used in the artificial infestation, and adult immersion test experiments were obtained from paddocks 1-9 in 2005 and 2015 from the commercial farm where the field studies were performed. Based on the obtained results, it was possible to conclude that amitraz use in rotation with pyrethroids every 28 days for three consecutive years (2002-2004) previous to the beginning of the first trial (2005) was sufficient to generate a R. (B.) microplus strain resistant to amitraz. Moreover, using field trials, artificial infestations (Stall tests) and adult immersion tests, we verified that 40 generations of the tick species with no

A prototype tap test imaging system: Initial field test results

Science.gov (United States)

Peters, J. J.; Barnard, D. J.; Hudelson, N. A.; Simpson, T. S.; Hsu, D. K.

2000-05-01

This paper describes a simple, field-worthy tap test imaging system that gives quantitative information about the size, shape, and severity of defects and damages. The system consists of an accelerometer, electronic circuits for conditioning the signal and measuring the impact duration, a laptop PC and data acquisition and processing software. The images are generated manually by tapping on a grid printed on a plastic sheet laid over the part's surface. A mechanized scanner is currently under development. The prototype has produced images for a variety of aircraft composite and metal honeycomb structures containing flaws, damages, and repairs. Images of the local contact stiffness, deduced from the impact duration using a spring model, revealed quantitatively the stiffness reduction due to flaws and damages, as well as the stiffness enhancement due to substructures. The system has been field tested on commercial and military aircraft as well as rotor blades and engine decks on helicopters. Field test results will be shown and the operation of the system will be demonstrated.—This material is based upon work supported by the Federal Aviation Administration under Contract #DTFA03-98-D-00008, Delivery Order No. IA016 and performed at Iowa State University's Center for NDE as part of the Center for Aviation Systems Reliability program.

Clinical Trials

Medline Plus

Full Text Available ... products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ... cancer also increased. As a result, the U.S. Food and Drug Administration now recommends never using HT ... Clinical Trials Work If you take ...

Clinical trials: bringing research to the bedside.

Science.gov (United States)

Arvay, C A

1991-02-01

Over the years, clinical trials with their structured treatment plans and multicenter involvement have been instrumental in developing new treatments and establishing standard of care therapy. While clinical trials strive to advance medical knowledge, they provide scientifically sound, state of the art care and their use should be increased. The Brain Tumor Cooperative Group, one such NCI-sponsored cooperative group, has been the primary group for the treatment of malignant gliomas. As the field of neuro-oncology expands, the neuroscience nurse needs to develop an understanding of clinical trials and their operation. The nurse is in an optimal position to support medical research and the research participant.

The psychometric properties of the personality inventory for DSM-5 in an APA DSM-5 field trial sample.

Science.gov (United States)

Quilty, Lena C; Ayearst, Lindsay; Chmielewski, Michael; Pollock, Bruce G; Bagby, R Michael

2013-06-01

Section 3 of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) includes a hybrid model of personality pathology, in which dimensional personality traits are used to derive one of seven categorical personality disorder diagnoses. The Personality Inventory for DSM-5 (PID-5) was developed by the DSM-5 Personality and Personality Disorders workgroup and their consultants to produce a freely available instrument to assess the personality traits within this new system. To date, the psychometric properties of the PID-5 have been evaluated primarily in undergraduate student and community adult samples. In the current investigation, we extend this line of research to a psychiatric patient sample who participated in the APA DSM-5 Field Trial (Centre for Addiction and Mental Health site). A total of 201 psychiatric patients (102 men, 99 women) completed the PID-5 and the Revised NEO Personality Inventory (NEO PI-R). The internal consistencies of the PID-5 domain and facet trait scales were acceptable. Results supported the unidimensional structure of all trait scales but one, and the convergence between the PID-5 and analogous NEO PI-R scales. Evidence for discriminant validity was mixed. Overall, the current investigation provides support for the psychometric properties of this diagnostic instrument in psychiatric samples.

Field trial on the spatial repellency of metofluthrin-impregnated plastic strips for mosquitoes in shelters without walls (beruga) in Lombok, Indonesia.

Science.gov (United States)

Kawada, Hitoshi; Maekawa, Yoshihide; Takagi, Masahiro

2005-12-01

Field trials on the spatial repellency of metofluthrin-impregnated plastic strips for mosquitoes present in shelters without walls (beruga) were carried out in Lombok, Indonesia. A major reduction in the incidence of human biting by Culex quinquefasciatus was achieved, and the use of two strips per beruga repelled >60% of the mosquitoes for at least 11 wk while four strips repelled >60% of the mosquitoes for more than 15 weeks. The technique was found to be a practical long-term solution for the prevention of mosquito bites without using electricity or heat to evaporate the metofluthrin.

Full Scale Field Trial of the Low Temperature Mercury Capture Process

Energy Technology Data Exchange (ETDEWEB)

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

2012-05-21

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

Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models

Directory of Open Access Journals (Sweden)

Singla NK

2014-12-01

Full Text Available Neil K Singla,1 Jacques E Chelly,2 David R Lionberger,3 Joseph Gimbel,4 Luis Sanin,5 Jonathan Sporn,5 Ruoyong Yang,5 Raymond Cheung,5 Lloyd Knapp,6 Bruce Parsons5 1Lotus Clinical Research, Pasadena, CA, USA; 2Division of Acute Interventional Perioperative Pain, Department of Anesthesiology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; 3Department of Orthopedic Surgery, Baylor College of Medicine, Houston, TX, USA; 4Arizona Research Center, Phoenix, AZ, USA; 5Pfizer Inc., New York, NY, USA; 6Pfizer Inc., New London, CT, USA Purpose: To evaluate the efficacy and safety of pregabalin (150 or 300 mg/d as an adjunctive therapy for the treatment of postoperative pain. Patients and methods: This study reports findings from three separate, multicenter, randomized, double-blind, placebo-controlled trials of adjunctive pregabalin for the treatment of postoperative pain. Patients underwent one of three categories of surgical procedures (one procedure per study: elective inguinal hernia repair (post-IHR; elective total knee arthroplasty (post-TKA; or total abdominal hysterectomy (posthysterectomy. The primary endpoint in each trial, mean worst pain over the past 24 hours, was assessed 24 hours post-IHR and posthysterectomy, and 48 hours post-TKA. Patients rated their pain on a scale from 0 to 10, with higher scores indicating greater pain severity. Results: In total, 425 (post-IHR, 307 (post-TKA, and 501 (posthysterectomy patients were randomized to treatment. There were no statistically significant differences between the pregabalin and placebo groups with respect to the primary endpoint in any of the three trials. The least squares mean difference in worst pain, between 300 mg/d pregabalin and placebo, was -0.7 (95% confidence interval [CI] =-1.4, -0.1; Hochberg adjusted P=0.067 post-IHR; -0.34 (95% CI =-1.07, 0.39; P=0.362 post-TKA; and -0.2 (95% CI =-0.66, 0.31; P=0.471 posthysterectomy. Conclusion: There were no significant differences

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

Directory of Open Access Journals (Sweden)

Dalia M. Kamel

2017-01-01

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

Weak-field asymptotic theory of tunneling ionization: benchmark analytical results for two-electron atoms

International Nuclear Information System (INIS)

Trinh, Vinh H; Morishita, Toru; Tolstikhin, Oleg I

2015-01-01

The recently developed many-electron weak-field asymptotic theory of tunneling ionization of atoms and molecules in an external static electric field (Tolstikhin et al 2014, Phys. Rev. A 89, 013421) is extended to the first-order terms in the asymptotic expansion in field. To highlight the results, here we present a simple analytical formula giving the rate of tunneling ionization of two-electron atoms H − and He. Comparison with fully-correlated ab initio calculations available for these systems shows that the first-order theory works quantitatively in a wide range of fields up to the onset of over-the-barrier ionization and hence is expected to find numerous applications in strong-field physics. (fast track communication)

Technical Note: Experimental results from a prototype high-field inline MRI-linac

Energy Technology Data Exchange (ETDEWEB)

Liney, G. P., E-mail: gary.liney@sswahs.nsw.gov.au [Department of Medical Physics, Ingham Institute for Applied Medical Research, Liverpool NSW 2170 (Australia); Dong, B.; Zhang, K. [Department of Medical Physics, Ingham Institute for Applied Medical Research, Liverpool NSW 2170 (Australia); and others

2016-09-15

Purpose: The pursuit of real-time image guided radiotherapy using optimal tissue contrast has seen the development of several hybrid magnetic resonance imaging (MRI)-treatment systems, high field and low field, and inline and perpendicular configurations. As part of a new MRI-linac program, an MRI scanner was integrated with a linear accelerator to enable investigations of a coupled inline MRI-linac system. This work describes results from a prototype experimental system to demonstrate the feasibility of a high field inline MR-linac. Methods: The magnet is a 1.5 T MRI system (Sonata, Siemens Healthcare) was located in a purpose built radiofrequency (RF) cage enabling shielding from and close proximity to a linear accelerator with inline (and future perpendicular) orientation. A portable linear accelerator (Linatron, Varian) was installed together with a multileaf collimator (Millennium, Varian) to provide dynamic field collimation and the whole assembly built onto a stainless-steel rail system. A series of MRI-linac experiments was performed to investigate (1) image quality with beam on measured using a macropodine (kangaroo) ex vivo phantom; (2) the noise as a function of beam state measured using a 6-channel surface coil array; and (3) electron contamination effects measured using Gafchromic film and an electronic portal imaging device (EPID). Results: (1) Image quality was unaffected by the radiation beam with the macropodine phantom image with the beam on being almost identical to the image with the beam off. (2) Noise measured with a surface RF coil produced a 25% elevation of background intensity when the radiation beam was on. (3) Film and EPID measurements demonstrated electron focusing occurring along the centerline of the magnet axis. Conclusions: A proof-of-concept high-field MRI-linac has been built and experimentally characterized. This system has allowed us to establish the efficacy of a high field inline MRI-linac and study a number of the technical

Recent clinical trials in valvular heart disease.

Science.gov (United States)

Kiss, Daniel; Anwaruddin, Saif

2017-07-01

With widespread adoption of transcatheter aortic valve replacement, there has been a change in the approach to management of valvular heart disease. New interest has taken hold in transcatheter therapies for valvular heart disease, as well as research into pathophysiology and progression of disease. Additionally, several key trials have further refined our understanding of surgical management of valvular heart disease. This review will elucidate recent clinical trial data leading to changes in practice. There have been several landmark trials expanding the indications for transcatheter aortic valve replacement. Additionally, although still early, trials are beginning to demonstrate the feasibility and safety of transcatheter mitral valves. Options for transcatheter management of right-sided valvular disease continue to evolve, and these are areas of active investigation. The emergence of novel therapies for valvular heart disease has expanded the management options available, allowing physicians to better individualize treatment of patients with valvular heart disease. This review will focus on the recent (within 2 years) trials in this field of interest.

Adaptive trials for tuberculosis: early reflections on theory and practice.

Science.gov (United States)

Montgomery, C M

2016-08-01

Adaptive designs (ADs) have been proposed for anti-tuberculosis treatment trials. This call for innovation occurs against the backdrop of fundamental changes in the acceptable evidence base in anti-tuberculosis treatment. To contextualise ADs for tuberculosis (TB) and explore early responses from those working in the field. In this qualitative study investigating processes of theoretical and practical change in randomised controlled trials, 24 interviews were conducted with professionals involved in AD trials, half of whom worked in the TB field. Clinical trialists working on AD trials in TB are positive about the efficiency these designs offer, but remain cautious about their suitability. In addition to technical concerns, informants discussed the challenges of implementing AD in developing countries, including limited regulatory capacity to evaluate proposals, investments needed in infrastructure and site capacity, and challenges regarding informed consent. Respondents identified funding, interdisciplinary communication and regulatory and policy responses as additional concerns potentially affecting the success of AD for TB. Empirical research is needed into patient experiences of AD, including informed consent. Further consideration of the contexts of innovation in trial design is needed. These are fundamental to the successful translation of theory into practice.

Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial).

Science.gov (United States)

Généreux, Philippe; Lee, Arthur C; Kim, Christopher Y; Lee, Michael; Shlofmitz, Richard; Moses, Jeffrey W; Stone, Gregg W; Chambers, Jeff W

2015-06-15

Percutaneous coronary intervention of severely calcified lesions has historically been associated with major adverse cardiac event (MACE) rates as high as 30%. In the ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial, treatment of de novo severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) resulted in low rates of procedural and 30-day adverse ischemic events. The long-term results from this trial have not been reported. We sought to determine the 1-year outcomes after orbital atherectomy of severely calcified coronary lesions. ORBIT II was a single-arm trial enrolling 443 subjects at 49 US sites with severely calcified lesions usually excluded from randomized trials. OAS utilizes a centrifugal differential sanding mechanism of action for plaque modification prior to stent implantation. After OAS drug-eluting stents were implanted in 88.2% of the patients. The primary safety end point was 30-day MACE, the composite of cardiac death, myocardial infarction, or target vessel revascularization [TVR]. The present analysis reports the 1-year follow-up results from ORBIT II. One-year data were available in 433 of 443 patients (97.7%), with median follow-up time of 16.7 months. The 1-year MACE rate was 16.4%, including cardiac death (3.0%), myocardial infarction (9.7%), and target vessel revascularization (5.9%). The 1-year target lesion revascularization rate was 4.7%, and stent thrombosis occurred in 1 patient (0.2%). Independent predictors of 1-year MACE and target vessel revascularization were diameter stenosis at baseline and the use of bare-metal stents. In patients with severely calcified lesions who underwent percutaneous coronary intervention, the use of OAS was associated with low rates of 1-year adverse ischemic events compared with historical controls. This finding has important clinical implications for the selection of optimum treatment strategies for patients

Results of Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) trial

NARCIS (Netherlands)

D.R. Holmes Jr (David); J.R. Granett (Jeffrey); J.J. Popma (Jeffrey); P.J. Fitzgerald (Peter); D. Fischman (David); J.J. Ferguson (James); A.M. Lincoff (Michael); S. Goldberg (Sheldon); J.A. Brinker; R. Chan; B.R. Davis (Barry); M. Poland; A.M. Zeiher (Andreas); J.T. Willerson (James); S.B. King 3rd (Spencer); L.M. Shapiro; M. Savage (Michael); J.M. Lablanche (Jean Marc); J.E. Tcheng (James); L. Grip (Lars); P.W.J.C. Serruys (Patrick)

2002-01-01

textabstractBACKGROUND: Restenosis after percutaneous coronary intervention (PCI) is a major problem affecting 15% to 30% of patients after stent placement. No oral agent has shown a beneficial effect on restenosis or on associated major adverse cardiovascular events. In limited trials, the oral

Results of the ITER toroidal field model coil project

International Nuclear Information System (INIS)

Salpietro, E.; Maix, R.

2001-01-01

In the scope of the ITER EDA one of the seven largest projects was devoted to the development, manufacture and testing of a Toroidal Field Model Coil (TFMC). The industry consortium AGAN manufactured the TFMC based on on a conceptual design developed by the ITER EDA EU Home Team. The TFMC was completed and assembled in the test facility TOSKA of the Forschungszentrum Karlsruhe in the first half of 2001. The first testing phase started in June 2001 and lasted till October 2001. The first results have shown that the main goals of the project have been achieved

Developing a Framework of Innovative Trials to Support Water Companies Strategic Response to WFD

Science.gov (United States)

Whitehead, Jodie; Cherry, Katherine; Revens, Neasa; O'Hanlon, Thomas

2014-05-01

Slug control in high risk fields and catchments can have serious implications for water companies, threatening compliance with drinking water standards and challenging the Water Framework Directive's requirement that additional water treatment is avoided. Severn Trent Water has established a framework of innovative trails at a range of scales and locations to help shape the company's strategic, sustainable response to elevated metaldehyde concentrations at drinking water abstractions. Currently four contrasting trials are underway, two at the catchment scale, one at the field scale and one at the 'operational site' scale at locations across the English Midlands. This presentation provides an overview of the different approaches, their effectiveness to date and lessons learnt to aid strategy development. The first trial entitled Farmer's as Producers of Clean Water adopts a 'results orientated' approach, rewarding farmers for improvements in water quality at the catchment scale and allowing farmers to decide how best to manage the issue on their land with no prescribed measures. It acknowledges that co-ordinated action is needed across the catchment to see improvements in water quality, and that by incentivising outcomes rather than actions, land owners and farmers may take greater ownership of water quality issues. The second project explores the potential for a 'zero metaldehyde' catchment with all farmers throughout the catchment being financial supported to use a water friendly alternative to metaldehyde. This project is being compared to more voluntary approaches adopted elsewhere. The third project is a field scale trial to test the efficacy of alternative products to metaldehyde and different pellet formulations. Field drains are being sampled following heavy rain and crop damaged assessed to review the benefits to water quality and crops. The final project considers what Severn Trent Water can do from an operational perspective, investigating the size and

Determination of errors in derived magnetic field directions in geosynchronous orbit: results from a statistical approach

Science.gov (United States)

Chen, Yue; Cunningham, Gregory; Henderson, Michael

2016-09-01

This study aims to statistically estimate the errors in local magnetic field directions that are derived from electron directional distributions measured by Los Alamos National Laboratory geosynchronous (LANL GEO) satellites. First, by comparing derived and measured magnetic field directions along the GEO orbit to those calculated from three selected empirical global magnetic field models (including a static Olson and Pfitzer 1977 quiet magnetic field model, a simple dynamic Tsyganenko 1989 model, and a sophisticated dynamic Tsyganenko 2001 storm model), it is shown that the errors in both derived and modeled directions are at least comparable. Second, using a newly developed proxy method as well as comparing results from empirical models, we are able to provide for the first time circumstantial evidence showing that derived magnetic field directions should statistically match the real magnetic directions better, with averaged errors ˜ 5°. In addition, our results suggest that the errors in derived magnetic field directions do not depend much on magnetospheric activity, in contrast to the empirical field models. Finally, as applications of the above conclusions, we show examples of electron pitch angle distributions observed by LANL GEO and also take the derived magnetic field directions as the real ones so as to test the performance of empirical field models along the GEO orbits, with results suggesting dependence on solar cycles as well as satellite locations. This study demonstrates the validity and value of the method that infers local magnetic field directions from particle spin-resolved distributions.

Triple blind intervention field trial to compare the outcome parameters of the preventive package being administered by community animal health workers

International Nuclear Information System (INIS)