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Sample records for arm trial preparing

  1. Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sydes Matthew R

    2012-09-01

    Full Text Available Abstract Background Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE is a randomized controlled trial that follows a novel multi-arm, multi-stage (MAMS design. We describe methodological and practical issues arising with (1 stopping recruitment to research arms following a pre-planned intermediate analysis and (2 adding a new research arm during the trial. Methods STAMPEDE recruits men who have locally advanced or metastatic prostate cancer who are starting standard long-term hormone therapy. Originally there were five research and one control arms, each undergoing a pilot stage (focus: safety, feasibility, three intermediate ‘activity’ stages (focus: failure-free survival, and a final ‘efficacy’ stage (focus: overall survival. Lack-of-sufficient-activity guidelines support the pairwise interim comparisons of each research arm against the control arm; these pre-defined activity cut-off becomes increasingly stringent over the stages. Accrual of further patients continues to the control arm and to those research arms showing activity and an acceptable safety profile. The design facilitates adding new research arms should sufficiently interesting agents emerge. These new arms are compared only to contemporaneously recruited control arm patients using the same intermediate guidelines in a time-delayed manner. The addition of new research arms is subject to adequate recruitment rates to support the overall trial aims. Results (1 Stopping Existing Therapy: After the second intermediate activity analysis, recruitment was discontinued to two research arms for lack-of-sufficient activity. Detailed preparations meant that changes were implemented swiftly at 100 international centers and recruitment continued seamlessly into Activity Stage III with 3 remaining research arms and the control arm. Further regulatory and ethical approvals were not required because this was already included in the

  2. Some recommendations for multi-arm multi-stage trials.

    Science.gov (United States)

    Wason, James; Magirr, Dominic; Law, Martin; Jaki, Thomas

    2016-04-01

    Multi-arm multi-stage designs can improve the efficiency of the drug-development process by evaluating multiple experimental arms against a common control within one trial. This reduces the number of patients required compared to a series of trials testing each experimental arm separately against control. By allowing for multiple stages experimental treatments can be eliminated early from the study if they are unlikely to be significantly better than control. Using the TAILoR trial as a motivating example, we explore a broad range of statistical issues related to multi-arm multi-stage trials including a comparison of different ways to power a multi-arm multi-stage trial; choosing the allocation ratio to the control group compared to other experimental arms; the consequences of adding additional experimental arms during a multi-arm multi-stage trial, and how one might control the type-I error rate when this is necessary; and modifying the stopping boundaries of a multi-arm multi-stage design to account for unknown variance in the treatment outcome. Multi-arm multi-stage trials represent a large financial investment, and so considering their design carefully is important to ensure efficiency and that they have a good chance of succeeding. PMID:23242385

  3. Feasibility of a multidimensional home-based exercise programme for the elderly with structured support given by the general practitioner's surgery: Study protocol of a single arm trial preparing an RCT [ISRCTN58562962

    Directory of Open Access Journals (Sweden)

    Burghaus Ina

    2009-08-01

    Full Text Available Abstract Background Physical activity programmes can help to prevent functional decline in the elderly. Until now, such programmes use to target either on healthy community-dwelling seniors or on elderly living in special residences or care institutions. Sedentary or frail people, however, are difficult to reach when they live in their own homes. The general practitioner's (GP practice offers a unique opportunity to acquire these people for participation in activity programmes. We conceptualised a multidimensional home-based exercise programme that shall be delivered to the target group through cooperation between GPs and exercise therapists. In order to prepare a randomised controlled trial (RCT, a feasibility study is being conducted. Methods The study is designed as a single arm interventional trial. We plan to recruit 90 patients aged 70 years and above through their GPs. The intervention lasts 12 weeks and consists of physical activity counselling, a home-exercise programme, and exercise consultations provided by an exercise therapist in the GP's practice and via telephone. The exercise programme consists of two main components: 1. a combination of home-exercises to improve strength, flexibility and balance, 2. walking for exercise to improve aerobic capacity. Primary outcome measures are: appraisal by GP, undesirable events, drop-outs, adherence. Secondary outcome measures are: effects (a. motor tests: timed-up-and-go, chair rising, grip strength, tandem stand, tandem walk, sit-and-reach; b. telephone interview: PRISCUS-Physical Activity Questionnaire, Short Form-8 Health Survey, three month recall of frequency of falls, Falls Efficacy Scale, appraisal by participant, exercise performance, focus group discussion. Data analyses will focus on: 1. decision-making concerning the conduction of a RCT, 2. estimation of the effects of the programme, detection of shortcomings and identification of subgroups with contrary results, 3. feedback to

  4. Generation of "virtual" control groups for single arm prostate cancer adjuvant trials.

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    Zhenyu Jia

    Full Text Available It is difficult to construct a control group for trials of adjuvant therapy (Rx of prostate cancer after radical prostatectomy (RP due to ethical issues and patient acceptance. We utilized 8 curve-fitting models to estimate the time to 60%, 65%, … 95% chance of progression free survival (PFS based on the data derived from Kattan post-RP nomogram. The 8 models were systematically applied to a training set of 153 post-RP cases without adjuvant Rx to develop 8 subsets of cases (reference case sets whose observed PFS times were most accurately predicted by each model. To prepare a virtual control group for a single-arm adjuvant Rx trial, we first select the optimal model for the trial cases based on the minimum weighted Euclidean distance between the trial case set and the reference case set in terms of clinical features, and then compare the virtual PFS times calculated by the optimum model with the observed PFSs of the trial cases by the logrank test. The method was validated using an independent dataset of 155 post-RP patients without adjuvant Rx. We then applied the method to patients on a Phase II trial of adjuvant chemo-hormonal Rx post RP, which indicated that the adjuvant Rx is highly effective in prolonging PFS after RP in patients at high risk for prostate cancer recurrence. The method can accurately generate control groups for single-arm, post-RP adjuvant Rx trials for prostate cancer, facilitating development of new therapeutic strategies.

  5. Design and analysis of three-arm trials with negative binomially distributed endpoints.

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    Mütze, Tobias; Munk, Axel; Friede, Tim

    2016-02-20

    A three-arm clinical trial design with an experimental treatment, an active control, and a placebo control, commonly referred to as the gold standard design, enables testing of non-inferiority or superiority of the experimental treatment compared with the active control. In this paper, we propose methods for designing and analyzing three-arm trials with negative binomially distributed endpoints. In particular, we develop a Wald-type test with a restricted maximum-likelihood variance estimator for testing non-inferiority or superiority. For this test, sample size and power formulas as well as optimal sample size allocations will be derived. The performance of the proposed test will be assessed in an extensive simulation study with regard to type I error rate, power, sample size, and sample size allocation. For the purpose of comparison, Wald-type statistics with a sample variance estimator and an unrestricted maximum-likelihood estimator are included in the simulation study. We found that the proposed Wald-type test with a restricted variance estimator performed well across the considered scenarios and is therefore recommended for application in clinical trials. The methods proposed are motivated and illustrated by a recent clinical trial in multiple sclerosis. The R package ThreeArmedTrials, which implements the methods discussed in this paper, is available on CRAN. PMID:26388314

  6. Spontaneous improvement in randomised clinical trials: meta-analysis of three-armed trials comparing no treatment, placebo and active intervention

    DEFF Research Database (Denmark)

    Krogsbøll, Lasse Theis; Hróbjartsson, Asbjørn; Gøtzsche, Peter C

    2009-01-01

    were psychological in 17 trials, physical in 15 trials, and pharmacological in 5 trials. Overall, across all conditions and interventions, there was a statistically significant change from baseline in all three arms. The standardized mean difference (SMD) for change from baseline was -0.24 (95...... from baseline, and we aimed at quantifying these contributions. METHODS: Systematic review and meta-analysis, based on a Cochrane review of the effect of placebo interventions for all clinical conditions. We selected all trials that had randomised the patients to three arms: no treatment, placebo and...

  7. A multi-arm multi-stage clinical trial design for binary outcomes with application to tuberculosis

    OpenAIRE

    Bratton, D. J.; Phillips, P. P.; Parmar, M. K.

    2013-01-01

    Background Randomised controlled trials are becoming increasingly costly and time-consuming. In 2011, Royston and colleagues proposed a particular class of multi-arm multi-stage (MAMS) designs intended to speed up the evaluation of new treatments in phase II and III clinical trials. Their design, which controls the type I error rate and power for each pairwise comparison, discontinues randomisation to poorly performing arms at interim analyses if they fail to show a pre-specified level of ben...

  8. Comparison of intervention effects in split-mouth and parallel-arm randomized controlled trials: a meta-epidemiological study

    OpenAIRE

    Smaïl-Faugeron, Violaine; Fron-Chabouis, Hélène; Courson, Frédéric; Durieux, Pierre

    2014-01-01

    Background Split-mouth randomized controlled trials (RCTs) are popular in oral health research. Meta-analyses frequently include trials of both split-mouth and parallel-arm designs to derive combined intervention effects. However, carry-over effects may induce bias in split- mouth RCTs. We aimed to assess whether intervention effect estimates differ between split- mouth and parallel-arm RCTs investigating the same questions. Methods We performed a meta-epidemiological study. We systematically...

  9. Multi-armed Bandit Models for the Optimal Design of Clinical Trials: Benefits and Challenges

    Science.gov (United States)

    Villar, Sofía S.; Bowden, Jack; Wason, James

    2016-01-01

    Multi-armed bandit problems (MABPs) are a special type of optimal control problem well suited to model resource allocation under uncertainty in a wide variety of contexts. Since the first publication of the optimal solution of the classic MABP by a dynamic index rule, the bandit literature quickly diversified and emerged as an active research topic. Across this literature, the use of bandit models to optimally design clinical trials became a typical motivating application, yet little of the resulting theory has ever been used in the actual design and analysis of clinical trials. To this end, we review two MABP decision-theoretic approaches to the optimal allocation of treatments in a clinical trial: the infinite-horizon Bayesian Bernoulli MABP and the finite-horizon variant. These models possess distinct theoretical properties and lead to separate allocation rules in a clinical trial design context. We evaluate their performance compared to other allocation rules, including fixed randomization. Our results indicate that bandit approaches offer significant advantages, in terms of assigning more patients to better treatments, and severe limitations, in terms of their resulting statistical power. We propose a novel bandit-based patient allocation rule that overcomes the issue of low power, thus removing a potential barrier for their use in practice.

  10. Symbolic representations of weapons and preparations for conflict: The nuclear arms race

    Energy Technology Data Exchange (ETDEWEB)

    Bassin, E.L.

    1991-01-01

    This study investigates the process through which actors acquire weapons in preparation for a confrontation with some rival. A theory is developed to account for those preparations rooted in two social psychological perspectives; social exchange theory and symbolic interactionism. The empirical aspect of the study deals with the nuclear arms race between the US and Soviet Union. The first portion involves a qualitative analysis to uncover the meaning system. The second portion involves a quantitative test of the theory. Data cover all 53 long range strategic missile systems ever deployed by the US or USSR. Results lend support for the idea of a meaning-based theory of preparation for conflict. By operationalizing weapons as actors perceive the objects in their environment, the results of this study provide a higher level of fit than found in earlier arms race research.

  11. Symbolic representations of weapons and preparations for conflict: The nuclear arms race

    International Nuclear Information System (INIS)

    This study investigates the process through which actors acquire weapons in preparation for a confrontation with some rival. A theory is developed to account for those preparations rooted in two social psychological perspectives; social exchange theory and symbolic interactionism. The empirical aspect of the study deals with the nuclear arms race between the US and Soviet Union. The first portion involves a qualitative analysis to uncover the meaning system. The second portion involves a quantitative test of the theory. Data cover all 53 long range strategic missile systems ever deployed by the US or USSR. Results lend support for the idea of a meaning-based theory of preparation for conflict. By operationalizing weapons as actors perceive the objects in their environment, the results of this study provide a higher level of fit than found in earlier arms race research

  12. Armes

    OpenAIRE

    Camps, G.; Chenorkian, R.; Lhote, H.

    2013-01-01

    Préhistoire (G. Camps) Les armes des Paléoberbères de la Préhistoire ne présentent guère d’originalité mais à la documentation archéologique provenant de fouilles s’ajoute, en Afrique du Nord et au Sahara, une documentation iconographique d’une grande richesse que ne possèdent pas les autres pays riverains du bassin occidental de la Méditerranée. Durant les temps paléolithiques, les hommes qui occupèrent le Maghreb et le Sahara utilisèrent, en plus des outils et armes connus ailleurs ; biface...

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

    DEFF Research Database (Denmark)

    Dunning, Jake; Sahr, Foday; Rojek, Amanda;

    2016-01-01

    BACKGROUND: TKM-130803, a small interfering RNA lipid nanoparticle product, has been developed for the treatment of Ebola virus disease (EVD), but its efficacy and safety in humans has not been evaluated. METHODS AND FINDINGS: In this single-arm phase 2 trial, adults with laboratory-confirmed EVD...... of TKM-130803 at a dose of 0.3 mg/kg/d by intravenous infusion to adult patients with severe EVD was not shown to improve survival when compared to historic controls. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR201501000997429.......BACKGROUND: TKM-130803, a small interfering RNA lipid nanoparticle product, has been developed for the treatment of Ebola virus disease (EVD), but its efficacy and safety in humans has not been evaluated. METHODS AND FINDINGS: In this single-arm phase 2 trial, adults with laboratory-confirmed EVD...... received 0.3 mg/kg of TKM-130803 by intravenous infusion once daily for up to 7 d. On days when trial enrolment capacity was reached, patients were enrolled into a concurrent observational cohort. The primary outcome was survival to day 14 after admission, excluding patients who died within 48 h...

  14. Spontaneous improvement in randomised clinical trials: meta-analysis of three-armed trials comparing no treatment, placebo and active intervention

    Directory of Open Access Journals (Sweden)

    Gøtzsche Peter C

    2009-01-01

    Full Text Available Abstract Background It can be challenging for patients and clinicians to properly interpret a change in the clinical condition after a treatment has been given. It is not known to which extent spontaneous improvement, effect of placebo and effect of active interventions contribute to the observed change from baseline, and we aimed at quantifying these contributions. Methods Systematic review and meta-analysis, based on a Cochrane review of the effect of placebo interventions for all clinical conditions. We selected all trials that had randomised the patients to three arms: no treatment, placebo and active intervention, and that had used an outcome that was measured on a continuous scale or on a ranking scale. Clinical conditions that had been studied in less than three trials were excluded. Results We analysed 37 trials (2900 patients that covered 8 clinical conditions. The active interventions were psychological in 17 trials, physical in 15 trials, and pharmacological in 5 trials. Overall, across all conditions and interventions, there was a statistically significant change from baseline in all three arms. The standardized mean difference (SMD for change from baseline was -0.24 (95% confidence interval -0.36 to -0.12 for no treatment, -0.44 (-0.61 to -0.28 for placebo, and -1.01 (-1.16 to -0.86 for active treatment. Thus, on average, the relative contributions of spontaneous improvement and of placebo to that of the active interventions were 24% and 20%, respectively, but with some uncertainty, as indicated by the confidence intervals for the three SMDs. The conditions that had the most pronounced spontaneous improvement were nausea (45%, smoking (40%, depression (35%, phobia (34% and acute pain (25%. Conclusion Spontaneous improvement and effect of placebo contributed importantly to the observed treatment effect in actively treated patients, but the relative importance of these factors differed according to clinical condition and intervention.

  15. Effectiveness of alcohol brief intervention delivered by community pharmacists: study protocol of a two-arm randomised controlled trial

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    Dhital Ranjita

    2013-02-01

    Full Text Available Abstract Background There is strong evidence to support the effectiveness of Brief Intervention (BI in reducing alcohol consumption in primary healthcare. Methods and design This study is a two-arm randomised controlled trial to determine the effectiveness of BI delivered by community pharmacists in their pharmacies. Eligible and consenting participants (aged 18 years or older will be randomised in equal numbers to either a BI delivered by 17 community pharmacists or a non-intervention control condition. The intervention will be a brief motivational discussion to support a reduction in alcohol consumption and will take approximately 10 minutes to deliver. Participants randomised to the control arm will be given an alcohol information leaflet with no opportunity for discussion. Study pharmacists will be volunteers who respond to an invitation to participate, sent to all community pharmacists in the London borough of Hammersmith and Fulham. Participating pharmacists will receive 7 hours training on trial procedures and the delivery of BI. Pharmacy support staff will also receive training (4 hours on how to approach and inform pharmacy customers about the study, with formal trial recruitment undertaken by the pharmacist in a consultation room. At three month follow up, alcohol consumption and related problems will be assessed with the Alcohol Use Disorders Identification Test (AUDIT administered by telephone. Discussion The UK Department of Health’s stated aim is to involve community pharmacists in the delivery of BI to reduce alcohol harms. This will be the first RCT study to assess the effectiveness of BI delivered by community pharmacists. Given this policy context, it is pragmatic in design. Trial registration Current Controlled Trials ISRCTN95216873

  16. Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial

    OpenAIRE

    Lee, Seunghoon; Kim, Joo-Hee; Shin, Kyung-Min; Kim, Jung-Eun; Kim, Tae-Hun; Kang, Kyung-Won; Lee, Minhee; Jung, So-Young; Shin, Mi-Suk; Kim, Ae-Ran; Park, Hyo-Ju; Hong, Kwon-Eui; Choi, Sun-Mi

    2013-01-01

    Background The purpose of this study is to conduct a basic analysis of the effectiveness and safety of electroacupuncture in the treatment of painful diabetic neuropathy (PDN) as compared to placebo and usual care and to evaluate the feasibility of large-scale clinical research. Methods/design This study is a protocol for a three-armed, randomized, patient-assessor-blinded (to the type of treatment), controlled pilot trial. Forty-five participants with a ≥ six month history of PDN and a mean ...

  17. Biological 18[F]-FDG-PET image-guided dose painting by numbers for painful uncomplicated bone metastases: A 3-arm randomized phase II trial

    International Nuclear Information System (INIS)

    Background: Antalgic radiotherapy for bone metastases might be improved by implementing biological information in the radiotherapy planning using 18F-FDG-PET-CT based dose painting by numbers (DPBN). Materials and methods: Patients with uncomplicated painful bone metastases were randomized (1:1:1) and blinded to receive either 8 Gy in a single fraction with conventionally planned radiotherapy (arm A) or 8 Gy in a single fraction with DPBN (dose range between 610 Gy and 10 Gy) (arm B) or 16 Gy in a single fraction with DPBN (dose range between 1410 Gy and 18 Gy) (arm C). The primary endpoint was overall pain response at 1 month. The phase II trial was designed to select the experimental arm with sufficient promise of efficacy to continue to a phase III trial. Results: Forty-five patients were randomized. Eight (53%), 12 (80%) and 9 patients (60%) had an overall response to treatment in arm A, B and C, respectively. The estimated odds ratio of overall response for arm B vs. A is 3.5 (95% CI: 0.44–17.71, p = 0.12). The estimated odds ratio of arm C vs. A is 1.31 (95% CI: 0.31–5.58, p = 0.71). Conclusion: A single fraction of 8 Gy with DPBN will be further evaluated in a phase III-trial

  18. Video Helps Prepare Patients to Participate in Cancer Trials

    Science.gov (United States)

    Patients who took part in a tailored, video-based educational program had a better understanding of and fewer concerns about participating in clinical trials than patients who received text-based educational.

  19. Preparing for future efficacy trials of severe malaria vaccines.

    Science.gov (United States)

    Gonçalves, Bronner P; Prevots, D Rebecca; Kabyemela, Edward; Fried, Michal; Duffy, Patrick E

    2016-04-01

    Severe malaria is a major cause of mortality in children, but comprises only a small proportion of Plasmodium falciparum infections in naturally exposed populations. The evaluation of vaccines that prevent severe falciparum disease will require clinical trials whose primary efficacy endpoint will be severe malaria risk during follow-up. Here, we show that such trials are feasible with fewer than 1000 participants in areas with intense malaria transmission during the age interval when severe malaria incidence peaks. PMID:26923455

  20. The Anglo-Scandinavian Cardiac Outcomes Trial lipid lowering arm: extended observations 2 years after trial closure

    DEFF Research Database (Denmark)

    Sever, Peter S; Poulter, Neil R; Dahlof, Bjorn;

    2008-01-01

    -BPLA) compared two different antihypertensive treatment strategies on cardiovascular outcomes. ASCOT-LLA was a double-blind placebo-controlled trial of atorvastatin in those enrolled into ASCOT-BPLA with total cholesterol concentrations at baseline of <= 6.5 mmol/L. A total of 19 342 hypertensive patients were...... enrolled in ASCOT-BPLA and 10 305 were further assigned either atorvastatin, 10 mg, or placebo. ASCOT-LLA was stopped prematurely after a median 3.3 years follow-up because of substantial cardiovascular benefits in those assigned atorvastatin. Trial physicians were invited to offer atorvastatin to all...

  1. Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for cancer

    International Nuclear Information System (INIS)

    Background: A non-randomised phase II study suggested a therapeutic effect of hyperbaric oxygen (HBO) therapy on arm lymphoedema following adjuvant radiotherapy for early breast cancer, justifying further investigation in a randomised trial. Methods: Fifty-eight patients with ≥15% increase in arm volume after supraclavicular ± axillary radiotherapy (axillary surgery in 52/58 patients) were randomised in a 2:1 ratio to HBO (n = 38) or to best standard care (n = 20). The HBO group breathed 100% oxygen at 2.4 atmospheres absolute for 100 min on 30 occasions over 6 weeks. Primary endpoint was ipsilateral limb volume expressed as a percentage of contralateral limb volume. Secondary endpoints included fractional removal rate of radioisotopic tracer from the arm, extracellular water content, patient self-assessments and UK SF-36 Health Survey Questionnaire. Findings: Of 53/58 (91.4%) patients with baseline assessments, 46 had 12-month assessments (86.8%). Median volume of ipsilateral limb (relative to contralateral) at baseline was 133.5% (IQR 126.0-152.3%) in the control group, and 135.5% (IQR 126.5-146.0%) in the treatment group. Twelve months after baseline the median (IQR) volume of the ipsilateral limb was 131.2% (IQR 122.7-151.5%) in the control group and 133.5% (IQR 122.3-144.9%) in the treatment group. Results for the secondary endpoints were similar between randomised groups. Interpretation: No evidence has been found of a beneficial effect of HBO in the treatment of arm lymphoedema following primary surgery and adjuvant radiotherapy for early breast cancer.

  2. EEG signatures of arm isometric exertions in preparation, planning and execution.

    Science.gov (United States)

    Nasseroleslami, Bahman; Lakany, Heba; Conway, Bernard A

    2014-04-15

    The electroencephalographic (EEG) activity patterns in humans during motor behaviour provide insight into normal motor control processes and for diagnostic and rehabilitation applications. While the patterns preceding brisk voluntary movements, and especially movement execution, are well described, there are few EEG studies that address the cortical activation patterns seen in isometric exertions and their planning. In this paper, we report on time and time-frequency EEG signatures in experiments in normal subjects (n=8), using multichannel EEG during motor preparation, planning and execution of directional centre-out arm isometric exertions performed at the wrist in the horizontal plane, in response to instruction-delay visual cues. Our observations suggest that isometric force exertions are accompanied by transient and sustained event-related potentials (ERP) and event-related (de-)synchronisations (ERD/ERS), comparable to those of a movement task. Furthermore, the ERPs and ERD/ERS are also observed during preparation and planning of the isometric task. Comparison of ear-lobe-referenced and surface Laplacian ERPs indicates the contribution of superficial sources in supplementary and pre-motor (FC(z)), parietal (CP(z)) and primary motor cortical areas (C₁ and FC₁) to ERPs (primarily negative peaks in frontal and positive peaks in parietal areas), but contribution of deep sources to sustained time-domain potentials (negativity in planning and positivity in execution). Transient and sustained ERD patterns in μ and β frequency bands of ear-lobe-referenced and surface Laplacian EEG indicate the contribution of both superficial and deep sources to ERD/ERS. As no physical displacement happens during the task, we can infer that the underlying mechanisms of motor-related ERPs and ERD/ERS patterns do not only depend on change in limb coordinate or muscle-length-dependent ascending sensory information and are primary generated by motor preparation, direction

  3. Using pilot data to size a two-arm randomized trial to find a nearly optimal personalized treatment strategy.

    Science.gov (United States)

    Laber, Eric B; Zhao, Ying-Qi; Regh, Todd; Davidian, Marie; Tsiatis, Anastasios; Stanford, Joseph B; Zeng, Donglin; Song, Rui; Kosorok, Michael R

    2016-04-15

    A personalized treatment strategy formalizes evidence-based treatment selection by mapping patient information to a recommended treatment. Personalized treatment strategies can produce better patient outcomes while reducing cost and treatment burden. Thus, among clinical and intervention scientists, there is a growing interest in conducting randomized clinical trials when one of the primary aims is estimation of a personalized treatment strategy. However, at present, there are no appropriate sample size formulae to assist in the design of such a trial. Furthermore, because the sampling distribution of the estimated outcome under an estimated optimal treatment strategy can be highly sensitive to small perturbations in the underlying generative model, sample size calculations based on standard (uncorrected) asymptotic approximations or computer simulations may not be reliable. We offer a simple and robust method for powering a single stage, two-armed randomized clinical trial when the primary aim is estimating the optimal single stage personalized treatment strategy. The proposed method is based on inverting a plugin projection confidence interval and is thereby regular and robust to small perturbations of the underlying generative model. The proposed method requires elicitation of two clinically meaningful parameters from clinical scientists and uses data from a small pilot study to estimate nuisance parameters, which are not easily elicited. The method performs well in simulated experiments and is illustrated using data from a pilot study of time to conception and fertility awareness. PMID:26506890

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

    Science.gov (United States)

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

    2016-01-01

    Background TKM-130803, a small interfering RNA lipid nanoparticle product, has been developed for the treatment of Ebola virus disease (EVD), but its efficacy and safety in humans has not been evaluated. Methods and Findings In this single-arm phase 2 trial, adults with laboratory-confirmed EVD received 0.3 mg/kg of TKM-130803 by intravenous infusion once daily for up to 7 d. On days when trial enrolment capacity was reached, patients were enrolled into a concurrent observational cohort. The primary outcome was survival to day 14 after admission, excluding patients who died within 48 h of admission. After 14 adults with EVD had received TKM-130803, the pre-specified futility boundary was reached, indicating a probability of survival to day 14 of ≤0.55, and enrolment was stopped. Pre-treatment geometric mean Ebola virus load in the 14 TKM-130803 recipients was 2.24 × 109 RNA copies/ml plasma (95% CI 7.52 × 108, 6.66 × 109). Two of the TKM-130803 recipients died within 48 h of admission and were therefore excluded from the primary outcome analysis. Of the remaining 12 TKM-130803 recipients, nine died and three survived. The probability that a TKM-130803 recipient who survived for 48 h will subsequently survive to day 14 was estimated to be 0.27 (95% CI 0.06, 0.58). TKM-130803 infusions were well tolerated, with 56 doses administered and only one possible infusion-related reaction observed. Three patients were enrolled in the observational cohort, of whom two died. Conclusions Administration of TKM-130803 at a dose of 0.3 mg/kg/d by intravenous infusion to adult patients with severe EVD was not shown to improve survival when compared to historic controls. Trial registration Pan African Clinical Trials Registry PACTR201501000997429 PMID:27093560

  5. Effects of preparation time and trial type probability on performance of anti- and pro-saccades.

    Science.gov (United States)

    Pierce, Jordan E; McDowell, Jennifer E

    2016-02-01

    Cognitive control optimizes responses to relevant task conditions by balancing bottom-up stimulus processing with top-down goal pursuit. It can be investigated using the ocular motor system by contrasting basic prosaccades (look toward a stimulus) with complex antisaccades (look away from a stimulus). Furthermore, the amount of time allotted between trials, the need to switch task sets, and the time allowed to prepare for an upcoming saccade all impact performance. In this study the relative probabilities of anti- and pro-saccades were manipulated across five blocks of interleaved trials, while the inter-trial interval and trial type cue duration were varied across subjects. Results indicated that inter-trial interval had no significant effect on error rates or reaction times (RTs), while a shorter trial type cue led to more antisaccade errors and faster overall RTs. Responses following a shorter cue duration also showed a stronger effect of trial type probability, with more antisaccade errors in blocks with a low antisaccade probability and slower RTs for each saccade task when its trial type was unlikely. A longer cue duration yielded fewer errors and slower RTs, with a larger switch cost for errors compared to a short cue duration. Findings demonstrated that when the trial type cue duration was shorter, visual motor responsiveness was faster and subjects relied upon the implicit trial probability context to improve performance. When the cue duration was longer, increased fixation-related activity may have delayed saccade motor preparation and slowed responses, guiding subjects to respond in a controlled manner regardless of trial type probability. PMID:26829023

  6. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework

    OpenAIRE

    Eldridge, Sandra M.; Lancaster, Gillian A.; Michael J. Campbell; Thabane, Lehana; Hopewell, Sally; Coleman, Claire L.; Bond, Christine M

    2016-01-01

    We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of ...

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

    Directory of Open Access Journals (Sweden)

    Jake Dunning

    2016-04-01

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

  8. Analysis of an ordinal outcome in a multicentric randomized controlled trial: application to a 3- arm anti- malarial drug trial in Cameroon

    Directory of Open Access Journals (Sweden)

    Gwét Henri

    2010-06-01

    Full Text Available Abstract Background Malaria remains a burden in Sub-Saharan Countries. The strategy proposed by the World Health Organization (WHO is to systematically compare the therapeutic efficacy of antimalarial drugs using as primary outcome for efficacy, a four-category ordered criterion. The objective of the present work was to analyze the treatment effects on this primary outcome taking into account both a center-effect and individual covariates. A three-arm, three-centre trial of Amodiaquine (AQ, sulfadoxine-pyrimethamine (SP and their combination (AQ + SP, conducted by OCEAC-IRD in 2003, in 538 children with uncomplicated Plasmodium falciparum malaria, is used as an illustration. Methods Analyses were based on ordinal regression methods, assuming an underlying continuous latent variable, using either the proportional odds (PO or the proportional hazards (PH models. Different algorithms, corresponding to both frequentist- and bayesian-approaches, were implemented using the freely available softwares R and Winbugs, respectively. The performances of the different methods were evaluated on a simulated data set, and then they were applied on the trial data set. Results Good coverage probability and type-1 error for the treatment effect were achieved. When the methods were applied on the trial data set, results highlighted a significance decrease of SP efficacy when compared to AQ (PO, odds ratio [OR] 0.14, 95% confidence interval [CI] 0.04-0.57; hazard ratio [HR] 0.605, 95% CI 0.42-0.82, and an equal effectiveness between AQ + SP and AQ (PO, odds ratio [OR] 1.70, 95% confidence interval [CI] 0.25-11.44; hazard ratio [HR] 1.40, 95% CI 0.88-2.18. The body temperature was significantly related to the responses. The patient weights were marginally associated to the clinical response. Conclusion The proposed analyses, based on usual statistical packages, appeared adapted to take into account the full information contained in the four categorical outcome in

  9. A phase III randomized three-arm trial of physical therapist delivered pain coping skills training for patients with total knee arthroplasty: the KASTPain protocol

    Directory of Open Access Journals (Sweden)

    Riddle Daniel L

    2012-08-01

    Full Text Available Abstract Background Approximately 20% of patients report persistent and disabling pain following total knee arthroplasty (TKA despite an apparently normally functioning prosthesis. One potential risk factor for unexplained persistent pain is high levels of pain catastrophizing. We designed a three-arm trial to determine if a pain coping skills training program, delivered prior to TKA, effectively reduces function-limiting pain following the procedure in patients with high levels of pain catastrophizing. Methods/design The trial will be conducted at four University-based sites in the US. A sample of 402 patients with high levels of pain catastrophizing will be randomly assigned to either a pain coping skills training arm, an arthritis education control arm or usual care. Pain coping skills will be delivered by physical therapists trained and supervised by clinical psychologist experts. Arthritis education will be delivered by nurses trained in the delivery of arthritis-related content. The primary outcome will be change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Pain scale score 12 months following surgery. A variety of secondary clinical and economic outcomes also will be evaluated. Discussion The trial will be conducted at four University-based sites in the US. A sample of 402 patients with high levels of pain catastrophizing will be randomly assigned to either a pain coping skills training arm, an arthritis education control arm or usual care. Pain coping skills will be delivered by physical therapists trained and supervised by clinical psychologist experts. Arthritis education will be delivered by nurses trained in the delivery of arthritis-related content. The primary outcome will be change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Pain scale score 12 months following surgery. A variety of secondary clinical and economic outcomes also will be evaluated. Trial Registration NCT

  10. Preparation of 4-arm star PELA and its encapsulation of rotavirus for drug delivery.

    Science.gov (United States)

    Qingcong, Li; Xiaoxia, Pan; Hongli, Li; Minglong, Yuan

    2015-08-01

    A relatively high molecular weight of 4-arm star PELA was obtained by ring-opening polymerization of l-lactic acid O-carboxyanhydride with 4-arm-PEG in the presence of DMAP as an initiator. The results via(1)H NMR and (13)C NMR show that the end of the star PELA chain is a hydroxyl group and the central core is a PEG group. Rotavirus (strain SA11) was incorporated into 4-arm star PELA microspheres formulated by the water in oil in water emulsification solvent extraction method. The microspheres produced were spherical, and the mean diameter was 1.34 μm with a narrow size distribution. The drug release profile displayed a low burst release effect of 1.8% on the first day and a sustained release of antigen over 100 days. After the immunization of mice, the microsphere-entrapped RV elicited improved and long-lasting IgA and IgG antibody response in serum detected by ELISA in comparison to the free RV antigen. This study shows that 4-arm-PEG is an effective initiator for the ring-opening polymerization of Lac-OCA by DMAP as an initiator and that the resulting polymer is useful as a delivery system for the rotavirus vaccine. PMID:26073940

  11. Thermosensitive porphyrin-incorporated hydrogel with four-arm PEG-PCL copolymer: preparation, characterization and fluorescence imaging in vivo.

    Science.gov (United States)

    Lv, Feng; Mao, Lina; Liu, Tianjun

    2014-10-01

    A biodegradable thermosensitive hydrogel based on four-arm PEG-PCL copolymer was prepared with porphyrin as a fluorescence tag. Its structure and composition were characterized by FTIR, (1)H NMR and GPC. Sol-gel-sol transition was evaluated by the test tube-inverting method and rheological analysis. The optical properties of hydrogel were investigated by UV-vis and fluorescence spectroscopy in vitro and by fluorescence imaging system in vivo. The results show that the thermosensitive hydrogel possesses dual function of fluorescence and injectability in vivo with good biocompatibility. Consequently it can be potentially applied in biomedical field as a visible implant for in situ monitoring. PMID:25175208

  12. Testing coordinate measuring arms with a geometric feature-based gauge: in situ field trials

    Science.gov (United States)

    Cuesta, E.; Alvarez, B. J.; Patiño, H.; Telenti, A.; Barreiro, J.

    2016-05-01

    This work describes in detail the definition of a procedure for calibrating and evaluating coordinate measuring arms (AACMMs or CMAs). CMAs are portable coordinate measuring machines that have been widely accepted in industry despite their sensitivity to the skill and experience of the operator in charge of the inspection task. The procedure proposed here is based on the use of a dimensional gauge that incorporates multiple geometric features, specifically designed for evaluating the measuring technique when CMAs are used, at company facilities (workshops or laboratories) and by the usual operators who handle these devices in their daily work. After establishing the procedure and manufacturing the feature-based gauge, the research project was complemented with diverse in situ field tests performed with the collaboration of companies that use these devices in their inspection tasks. Some of the results are presented here, not only comparing different operators but also comparing different companies. The knowledge extracted from these experiments has allowed the procedure to be validated, the defects of the methodologies currently used for in situ inspections to be detected, and substantial improvements for increasing the reliability of these portable instruments to be proposed.

  13. Testing coordinate measuring arms with a geometric feature-based gauge: in situ field trials

    International Nuclear Information System (INIS)

    This work describes in detail the definition of a procedure for calibrating and evaluating coordinate measuring arms (AACMMs or CMAs). CMAs are portable coordinate measuring machines that have been widely accepted in industry despite their sensitivity to the skill and experience of the operator in charge of the inspection task. The procedure proposed here is based on the use of a dimensional gauge that incorporates multiple geometric features, specifically designed for evaluating the measuring technique when CMAs are used, at company facilities (workshops or laboratories) and by the usual operators who handle these devices in their daily work. After establishing the procedure and manufacturing the feature-based gauge, the research project was complemented with diverse in situ field tests performed with the collaboration of companies that use these devices in their inspection tasks. Some of the results are presented here, not only comparing different operators but also comparing different companies. The knowledge extracted from these experiments has allowed the procedure to be validated, the defects of the methodologies currently used for in situ inspections to be detected, and substantial improvements for increasing the reliability of these portable instruments to be proposed. (paper)

  14. A Compound Herbal Preparation (CHP) in the Treatment of Children with ADHD: A Randomized Controlled Trial

    Science.gov (United States)

    Katz, M.; Adar Levine, A.; Kol-Degani, H.; Kav-Venaki, L.

    2010-01-01

    Objective: Evaluation of the efficacy of a patented, compound herbal preparation (CHP) in improving attention, cognition, and impulse control in children with ADHD. Method: Design: A randomized, double-blind, placebo-controlled trial. Setting: University-affiliated tertiary medical center. Participants: 120 children newly diagnosed with ADHD,…

  15. PREPARATION AND CHARACTERIZATION OF INCLUSION COMPLEXES OF TWO-ARM LINEAR AND FOUR-ARM STAR-SHAPED POLY(ε-CAPROLACTONE)S WITH α-CYCLODEXTRIN

    Institute of Scientific and Technical Information of China (English)

    Lu Wang; Jing-liang Wang; Chang-ming Dong

    2006-01-01

    Both four-arm star-shaped poly(ε-caprolactone) (4sPCL) and two-arm linear PCL (2LPCL) were synthesized and their inclusion complexation with α-cyclodextrin (α-CD) were studied. The inclusion complexes (ICs) formed between the PCL polymers and α-CD were characterized by 1H-NMR, DSC, TGA, WAXD, and FT-IR, respectively. Both branch arm number and molecular weight of the PCL polymers have apparent effect on the stoichiometry (CL:CD, mol:mol) of these ICs. All these analytical results indicate that the branch arms of the PCL polymers are incorporated into the hydrophobicα-CD cavities and their original crystalline properties are completely suppressed. Moreover, the inclusion complexation between two-arm linear or four-arm star-shaped PCL polymers and α-CD not only enhances the thermal stability of the guest PCL polymers but also improves that of α-CD.

  16. Impact of NGO Training and Support Intervention on Diarrhoea Management Practices in a Rural Community of Bangladesh: An Uncontrolled, Single-Arm Trial

    OpenAIRE

    Rahman, Ahmed S.; Mohammad Rafiqul Islam; Koehlmoos, Tracey P; Mohammad Jyoti Raihan; Mohammad Mehedi Hasan; Tahmeed Ahmed; Larson, Charles P.

    2014-01-01

    PURPOSE/OBJECTIVE: The evolving Non-Governmental Organization (NGO) sector in Bangladesh provides health services directly, however some NGOs indirectly provide services by working with unlicensed providers. The primary objective of this study was to examine the impact of NGO training of unlicensed providers on diarrhoea management and the scale up of zinc treatment in rural populations. METHODS: An uncontrolled, single-arm trial for a training and support intervention on diarrhoea outcomes w...

  17. Prospective evaluation of 2% (w/v alcoholic chlorhexidine gluconate as an antiseptic agent for blood donor arm preparation

    Directory of Open Access Journals (Sweden)

    Sweta Shah

    2014-01-01

    Full Text Available Aim: A prospective study was undertaken to evaluate the use of 2% (w/v alcoholic chlorhexidine gluconate (2% AlcCHG in donor arm preparation, to monitor the contamination rate of blood products after the collection and to find incidence of transfusion associated bacteremia. Settings and Design: Optimal skin antisepsis of the phlebotomy site is essential to minimize the risk of contamination. Food and Drug Administration (FDA in India has recommended antisepsis with three-step regimen of spirit-10% povidone iodine-spirit for donor arm antisepsis, but not with chlorhexidine, which is recommended by many other authors. Material and Methods: A total of 795 donors were studied from July 2011 to January 2012. Spirit-10% povidone iodine-spirit was used for 398 donors and 2% AlcCHG was used for 397 donors with the two-step method for arm antisepsis. Swabs were collected before and after use of antiseptic agents for all the donors. All the blood products collected from donors with growth in post-antisepsis swabs were cultured. A total of 123 various blood products were cultured irrespective of the method and result of antisepsis was observed. A total of seven patients had mild transfusion reaction. The transfused blood products, blood and urine specimen of the patients who had transfusion reaction were also cultured. Results: Seven donors out of 398 donors had growth in post-antisepsis swab with spirit-10% povidone iodine-spirit protocol and three donors out of 397 donors had growth in post-antisepsis swab with 2% AlcCHG protocol. All blood products collected from donors who had growth in post-antisepsis swabs when cultured had no growth. There was no contamination of blood products. Conclusions: Two percent (w/v alcoholic chlorhexidine gluconate with two-step protocol can be used as an antiseptic agent for donor arm preparation without considerable cost difference. It is at par with spirit 10% povidone iodine spirit protocol as suggested by FDA in India

  18. The effects of a home-based arm ergometry exercise programme on physical fitness, fatigue and activity in polio survivors: protocol for a randomised controlled trial

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    Murray Deirdre

    2012-12-01

    Full Text Available Abstract Background Many Polio survivors have reduced mobility, pain and fatigue, which make access to conventional forms of aerobic exercise difficult. Inactivity leads to increased risk of health problems, many of which are prevalent among Polio survivors. Aerobic exercise programmes in Polio survivors should utilise stable muscle groups and should be designed to minimise exacerbation of pain and fatigue. A home-based arm ergometry aerobic exercise programme may represent an affordable and accessible exercise modality, incorporating exercise prescription principles in this group. Methods/design This is a prospective, single blinded, randomised controlled trial. There are two arms; exercise intervention using arm ergometers and control. Polio survivors meeting eligibility criteria will be recruited and randomly allocated to intervention or control groups. Participants allocated to the intervention group will receive a small arm ergometer and a polar heart rate monitor. They will carry out a home-based moderate intensity (50-70% HRMax aerobic exercise programme for eight weeks, following instruction by the treating physiotherapist. Assessments will occur at baseline and after eight weeks and will include tests of physical fitness, activity, energy cost of walking, fatigue and quality of life. Clinically feasible assessment tools including the Six Minute Arm Test, the Physical Activity Scale for People with Physical Disabilities questionnaire, the Physiological Cost Index, Fatigue Severity Scale and the SF-36v2 will be utilised. Discussion The efficacy of a home-based arm ergometry programme in Polio survivors will be examined. No previous trial has examined such a programme using a wide range of outcome measures pertinent to Polio survivors. This study will provide new information on the impact of arm ergometry on physical fitness, activity, body composition, fatigue, pain, muscle strength, and health related quality of life. Also, the study

  19. A single-arm Phase II validation study of preventing oxaliplatin-induced hypersensitivity reactions by dexamethasone: the AVOID trial

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    Yoshida Y

    2015-11-01

    Full Text Available Yoichiro Yoshida,1 Keiji Hirata,2 Hiroshi Matsuoka,3 Shigeyoshi Iwamoto,4 Masahito Kotaka,5 Hideto Fujita,6 Naoya Aisu,1 Seiichiro Hoshino,1 Takeo Kosaka,6 Kotaro Maeda,3 Fumiaki Kiyomi,7 Yuichi Yamashita1 1Department of Gastroenterological Surgery, Fukuoka University Faculty of Medicine, Fukuoka, Japan; 2Department of Surgery, Fukuoka Sanno Hospital, Fukuoka, Japan; 3Department of Surgery, Fujita Health University School of Medicine, Toyoake, Japan; 4Department of Surgery, Kansai Medical University Hirakata Hospital, Osaka, Japan; 5Gastrointestinal Cancer Center, Sano Hospital, Kobe, Japan; 6Department of Surgical Oncology, Kanazawa Medical University, Uchinada, Japan; 7Academia, Industry and Government Collaborative Research Institute of Translational Medicine for Life Innovation, Fukuoka University, Fukuoka, Japan Background: Patients with colorectal cancer treated with oxaliplatin are at risk of hypersensitivity reactions, with the incidence estimated to be 12%–20%. Coinfusion of dexamethasone and oxaliplatin could potentially reduce the incidence of these reactions, but oxaliplatin is reported to be incompatible with alkaline compounds in solution. However, in a previous retrospective study we found that the pH of a solution of dexamethasone and oxaliplatin was less than 7.4, and that hypersensitivity to oxaliplatin could have been prevented by coinfusion of dexamethasone. We aimed to evaluate the effectiveness of coinfusion of dexamethasone and oxaliplatin to prevent oxaliplatin-induced hypersensitivity reactions.Patients and methods: The AVOID trial was a prospective, multicenter, open-label, single-arm Phase II trial conducted from January to September 2013. The study included 73 patients who received capecitabine plus oxaliplatin (XELOX or XELOX plus bevacizumab therapy for colorectal cancer. In all patients, oxaliplatin was administered in combination with dexamethasone. The primary outcome measure was the presence of

  20. Double-blind placebo-controlled randomised trial of vitamin E and pentoxifylline in patients with chronic arm lymphoedema and fibrosis after surgery and radiotherapy for breast cancer

    International Nuclear Information System (INIS)

    Background and purpose: Treatment-induced arm lymphoedema is a common and distressing complication of curative surgery and radiotherapy for early breast cancer. A number of studies testing alpha-tocopherol (vitamin E) and pentoxifylline suggest evidence of clinical regression of superficial radiation-induced fibrosis but there is only very limited evidence from randomised trials. Arm lymphoedema after lymphatic radiotherapy and surgery has been used in the present study as a clinical system for testing these drugs in a double-blind placebo-controlled randomised phase II trial. Patients and methods: Sixty-eight eligible research volunteers with a minimum 20% increase in arm volume at a median 15.5 years (range 2-41) after axillary/supraclavicular radiotherapy (plus axillary surgery in 51/68 (75%) cases) were randomised to active drugs or placebo. All volunteers were given dl-alpha tocopheryl acetate 500 mg twice a day orally plus pentoxifylline 400 mg twice a day orally, or corresponding placebos, for 6 months. The primary endpoint was volume of the ipsilateral limb measured opto-electronically using a perometer and expressed as a percentage of the contralateral limb volume. Results: At 12 months post-randomisation, there was no significant difference between treatment and control groups in terms of arm volume. Absolute change in arm volume at 12 months was 2.5% (95% CI -0.40 to 5.3) in the treatment group compared to 1.2% (95% CI -2.8 to 5.1) in the placebo group. The difference in mean volume change between randomisation groups at 12 months was not statistically significant (P=0.6), -1.3% (95% CI -6.1 to 3.5), nor was there a significant difference in response at 6 months (P=0.7), where mean change in arm volume from baseline in the treatment and placebo groups was -2.3% (95% CI -7.9 to 3.4) and -1.1% (95% CI -3.9 to 1.7), respectively. There were no significant differences between randomised groups in terms of secondary endpoints, including tissue induration

  1. Improving BPH symptoms and sexual dysfunctions with a saw palmetto preparation? Results from a pilot trial.

    Science.gov (United States)

    Suter, Andreas; Saller, Reinhard; Riedi, Eugen; Heinrich, Michael

    2013-02-01

    In elderly men, benign prostatic hyperplasia (BPH) is a major risk factor for sexual dysfunctions (SDys). Additionally, the standard treatments for BPH symptoms, alpha blockers and 5-alpha-reductase inhibitors, cause SDys themselves. Preparations from saw palmetto berries are an efficacious and well-tolerated symptomatic treatment for mild to moderate BPH and have traditionally been used to treat SDys. We conducted an open multicentric clinical pilot trial to investigate whether the saw palmetto berry preparation Prostasan® influenced BPH symptoms and SDys. Eighty-two patients participated in the 8-week trial, taking one capsule of 320 mg saw palmetto extract daily. At the end of the treatment, the International Prostate Symptom Score was reduced from 14.4 ± 4.7 to 6.9 ± 5.2 (p BPH QoL-9 sex total improved from 137.3 ± 47.9 to 195.0 ± 56.3 (p BPH symptoms and reduced SDys. This was the first trial with saw palmetto to show improvement in BPH symptoms and SDys as well. [Corrections made here after initial online publication.] PMID:22522969

  2. Effects of Action Observational Training Plus Brain-Computer Interface-Based Functional Electrical Stimulation on Paretic Arm Motor Recovery in Patient with Stroke: A Randomized Controlled Trial.

    Science.gov (United States)

    Kim, TaeHoon; Kim, SeongSik; Lee, ByoungHee

    2016-03-01

    The purpose of this study was to investigate whether action observational training (AOT) plus brain-computer interface-based functional electrical stimulation (BCI-FES) has a positive influence on motor recovery of paretic upper extremity in patients with stroke. This was a hospital-based, randomized controlled trial with a blinded assessor. Thirty patients with a first-time stroke were randomly allocated to one of two groups: the BCI-FES group (n = 15) and the control group (n = 15). The BCI-FES group administered to AOT plus BCI-FES on the paretic upper extremity five times per week during 4 weeks while both groups received conventional therapy. The primary outcomes were the Fugl-Meyer Assessment of the Upper Extremity, Motor Activity Log (MAL), Modified Barthel Index and range of motion of paretic arm. A blinded assessor evaluated the outcomes at baseline and 4 weeks. All baseline outcomes did not differ significantly between the two groups. After 4 weeks, the Fugl-Meyer Assessment of the Upper Extremity sub-items (total, shoulder and wrist), MAL (MAL-Activity of Use and Quality of Movement), Modified Barthel Index and wrist flexion range of motion were significantly higher in the BCI-FES group (p BCI-based FES is effective in paretic arm rehabilitation by improving the upper extremity performance. The motor improvements suggest that AOT plus BCI-based FES can be used as a therapeutic tool for stroke rehabilitation. The limitations of the study are that subjects had a certain limited level of upper arm function, and the sample size was comparatively small; hence, it is recommended that future large-scale trials should consider stratified and lager populations according to upper arm function. PMID:26301519

  3. Brain-Computer Interface-based robotic end effector system for wrist and hand rehabilitation: results of a three-armed randomized controlled trial for chronic stroke

    Directory of Open Access Journals (Sweden)

    Kai Keng eAng

    2014-07-01

    Full Text Available The objective of this study was to investigate the efficacy of an Electroencephalography (EEG-based Motor Imagery (MI Brain-Computer Interface (BCI coupled with a Haptic Knob (HK robot for arm rehabilitation in stroke patients. In this three-arm, single-blind, randomized controlled trial; 21 chronic hemiplegic stroke patients (Fugl-Meyer Motor Assessment (FMMA score 10-50, recruited after pre-screening for MI BCI ability, were randomly allocated to BCI-HK, HK or Standard Arm Therapy (SAT groups. All groups received 18 sessions of intervention over 6 weeks, 3 sessions per week, 90 minutes per session. The BCI-HK group received 1 hour of BCI coupled with HK intervention, and the HK group received 1 hour of HK intervention per session. Both BCI-HK and HK groups received 120 trials of robot-assisted hand grasping and knob manipulation followed by 30 minutes of therapist-assisted arm mobilization. The SAT group received 1.5 hours of therapist-assisted arm mobilization and forearm pronation-supination movements incorporating wrist control and grasp-release functions. In all, 14 males, 7 females, mean age 54.2 years, mean stroke duration 385.1 days, with baseline FMMA score 27.0 were recruited. The primary outcome measure was upper-extremity FMMA scores measured mid-intervention at week 3, end-intervention at week 6, and follow-up at weeks 12 and 24. Seven, 8 and 7 subjects underwent BCI-HK, HK and SAT interventions respectively. FMMA score improved in all groups, but no intergroup differences were found at any time points. Significantly larger motor gains were observed in the BCI-HK group compared to the SAT group at weeks 3, 12 and 24, but motor gains in the HK group did not differ from the SAT group at any time point. In conclusion, BCI-HK is effective, safe, and may have the potential for enhancing motor recovery in chronic stroke when combined with therapist-assisted arm mobilization.

  4. Novel 4-Arm Poly(Ethylene Glycol-Block-Poly(Anhydride-Esters Amphiphilic Copolymer Micelles Loading Curcumin: Preparation, Characterization, and In Vitro Evaluation

    Directory of Open Access Journals (Sweden)

    Li Lv

    2013-01-01

    Full Text Available A novel 4-arm poly(ethylene glycol-block-poly(anhydride-esters amphiphilic copolymer (4-arm PEG-b-PAE was synthesized by esterization of 4-arm poly(ethylene glycol and poly(anhydride-esters which was obtained by melt polycondensation of α-, ω-acetic anhydride terminated poly(L-lactic acid. The obtained 4-arm PEG-b-PAE was characterized by 1H-NMR and gel permeation chromatography. The critical micelle concentration of 4-arm PEG-b-PAE was 2.38 μg/mL. The curcumin-loaded 4-arm PEG-b-PAE micelles were prepared by a solid dispersion method and the drug loading content and encapsulation efficiency of the micelles were 7.0% and 85.2%, respectively. The curcumin-loaded micelles were spherical with a hydrodynamic diameter of 151.9 nm. Curcumin was encapsulated within 4-arm PEG-b-PAE micelles amorphously and released from the micelles, faster in pH 5.0 than pH 7.4, presenting one biphasic drug release pattern with rapid release at the initial stage and slow release later. The hemolysis rate of the curcumin-loaded 4-arm PEG-b-PAE micelles was 3.18%, which was below 5%. The IC50 value of the curcumin-loaded micelles against Hela cells was 10.21 μg/mL, lower than the one of free curcumin (25.90 μg/mL. The cellular uptake of the curcumin-loaded micelles in Hela cell increased in a time-dependent manner. The curcumin-loaded micelles could induce G2/M phase cell cycle arrest and apoptosis of Hela cells.

  5. Improving Preclinic Preparation for Patients with Chronic Conditions in Quito, Ecuador: A Randomized Controlled Trial

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    K. Rodriguez

    2015-01-01

    Full Text Available Objectives. As in many settings, patients in community health centers in Ecuador do not complete previsit forms or receive assistance to identify questions and concerns they would like to address in brief clinic visits with physicians. We examined the comparative effectiveness of providing (1 a previsit form to complete; (2 a previsit form along with assistance in completing the form; and (3 usual care. Methods. Parallel, three-arm randomized controlled trial in two health centers serving indigent to low-income communities in Quito, Ecuador, among 199 adult patients who took medications for at least one chronic condition. Outcome measures were self-reported satisfaction with the visit, confidence in asking questions, and extent to which patients’ objectives were met. Results. Patients who received assistance in completing a previsit form were more than twice as likely as participants in usual care to report achieving everything they wanted during their visit (AOR 2.2, P=0.039. There were no differences in any outcomes between the groups who received the previsit form with no assistance and usual care. Conclusions. For high-quality patient-centered primary care, it is important to develop and test innovative and scalable interventions for patients and physicians to make the best use of limited clinic time.

  6. Defining feasibility and pilot studies in preparation for randomised controlled trials:development of a conceptual framework

    OpenAIRE

    Eldridge, Sandra M.; Lancaster, Gillian A.; Michael J. Campbell; Thabane, Lehana; Hopewell, Sally; Coleman, Claire L.; Bond, Christine M

    2016-01-01

    We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of ...

  7. Preparation of human ovarian cancer ascites-derived exosomes for a clinical trial.

    Science.gov (United States)

    Navabi, H; Croston, D; Hobot, J; Clayton, A; Zitvogel, L; Jasani, B; Bailey-Wood, R; Wilson, K; Tabi, Z; Mason, M D; Adams, M

    2005-01-01

    Despite initial response to chemotherapy, at least 50% of ovarian cancer patients will relapse within 18 months. Progression-free survival is related to tumour infiltration with cytotoxic T lymphocytes (CTL). We recently demonstrated that CD8+ T cell responses to recall antigens improve following tumour response to chemotherapy. Vaccination designed to expand CTL, specific for tumour-associated antigens, may be a means of improving outcome. We are planning a clinical trial in advanced ovarian cancer patients undergoing chemotherapy using a combination of a Toll-like receptor 3 (TLR3) agonist and tumour-associated ascites-derived exosomes. Tumour-derived exosomes are a potential source of tumour antigens able to induce CD8+ T cell responses when loaded on mature dendritic cells (DC). DC maturation can be achieved with Toll-like receptor (TLR) agonists, such as the GMP-grade synthetic double stranded RNA, poly[I]:poly[C12U] (Ampligen) which is a TLR-3 agonist. Here, we describe the development of a method suitable for the preparation of GMP-grade exosomes from the ascites fluid of ovarian cancer patients, and the methods used for the molecular and immunological characterisation of these exosomes preceding their use in a clinical trial. PMID:16061407

  8. Epidemiology of malaria in an area prepared for clinical trials in Korogwe, north-eastern Tanzania

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    Francis Filbert

    2009-07-01

    Full Text Available Abstract Background Site preparation is a pre-requesite in conducting malaria vaccines trials. This study was conducted in 12 villages to determine malariometric indices and associated risk factors, during long and short rainy seasons, in an area with varying malaria transmission intensities in Korogwe district, Tanzania. Four villages had passive case detection (PCD of fever system using village health workers. Methods Four malariometric cross-sectional surveys were conducted between November 2005 and May 2007 among individuals aged 0–19 years, living in lowland urban, lowland rural and highland strata. A total of 10,766 blood samples were collected for malaria parasite diagnosis and anaemia estimation. Blood smears were stained with Giemsa while haemoglobin level was measured by HaemoCue. Socio-economic data were collected between Jan-Apr 2006. Results Adjusting for the effect of age, the risk of Plasmodium falciparum parasitaemia was significantly lower in both lowland urban, (OR = 0.26; 95%CI: 0.23–0.29, p Conclusion Higher SES and use of bed nets in the lowland urban could be the important factors for low malaria infections in this stratum. Results obtained here were used together with those from PCD and DSS in selecting a village for Phase 1b MSP3 vaccine trial, which was conducted in the study area in year 2008.

  9. Study protocol for a three-armed randomized controlled trial to assess whether house screening can reduce exposure to malaria vectors and reduce malaria transmission in The Gambia

    Directory of Open Access Journals (Sweden)

    Milligan Paul J

    2008-06-01

    Full Text Available Abstract Background Mosquito-proofing homes was one of the principal methods of environmental management in the early 1900s. House screening provides protection against malaria by reducing exposure to malaria parasites and has the added benefit of protecting everyone sleeping in the house, avoiding issues of inequity within the household. The aim of this study is to determine whether house screening protects people against malaria in Africa. It is hoped that this study will mark the beginning of a series of trials assessing a range of environmental interventions for malaria control in Africa. Design A 3-armed randomised-controlled trial will be conducted in and around Farafenni town in The Gambia, West Africa, to assess whether screening windows, doors and closing eaves or installing netting ceilings in local houses can substantially reduce malaria transmission and anaemia compared to homes with no screening. Eligible houses will be sorted and stratified by location and the number of children in each house, then randomly allocated to the interventions in blocks of 5 houses (2 with full screening, 2 with screened ceilings and 1 control house without screening. Risk of malaria transmission will be assessed in each house by routine collections of mosquitoes using light traps and an anaemia prevalence study in children at the end of the main transmission period. Discussion Practical issues concerning intervention implementation, as well as the potential benefits and risks of the study, are discussed. Trial Registration ISRCTN51184253 – Screening-homes to prevent malaria

  10. Preparations for the next generation of clinical trials with proton therapy

    International Nuclear Information System (INIS)

    ). Why are proton centers not collaborating more closely? One reason is that they are r hindered by a lack of uniformity in medical and physics practices among the 20 proton centers presently treating patients. In some cases, where the differences are due to markedly dissimilar equipment, adequate uniformity may be difficult or impossible to achieve. Fortunately, however, in many areas the uniformity in practice can and should be improved though the adoption of common dosimetry and reporting methods. These efforts could, to a large extent, harmonize proton QA practices with the established corresponding methods for external-beam photon therapy. In addition, future protocol writers will need various site-specific and class solutions. Established methods from conventional therapy do not work well for some sites. For example, Moyers et al. describes difficulties with the ICRU 50 recommendations on prescribing and reporting doses (intended for photons) when applied to proton therapy of the lung. Hence, we aim to facilitate clear communication between the physicians who write the clinical trial protocols and physicists who are responsible for providing the dosimetry necessary to carry them out. The third and final area of preparation that we shall discuss is the standardization of QA methodologies for proton dosimetry. At MGH we have adopted many QA techniques from external-beam photon and electron experience. However, proton dosimetry, and hence the needs for a QA program, is in several ways quite different, owing to the unique properties of proton beams and also to the comparatively immature state of commercial proton therapy equipment, e.g. as compared to commercial electron linear accelerators. In addition, the conduct of multi-institutional clinical trials demands a high degree of consistency. A mechanism is required for conducting independent verification of the dose delivered to patients at institutions participating in clinical trials. In some cases, credentialing

  11. SMA CARNIVAL TRIAL PART II: a prospective, single-armed trial of L-carnitine and valproic acid in ambulatory children with spinal muscular atrophy.

    Directory of Open Access Journals (Sweden)

    John T Kissel

    Full Text Available BACKGROUND: Multiple lines of evidence have suggested that valproic acid (VPA might benefit patients with spinal muscular atrophy (SMA. The SMA CARNIVAL TRIAL was a two part prospective trial to evaluate oral VPA and L-carnitine in SMA children. Part 1 targeted non-ambulatory children ages 2-8 in a 12 month cross over design. We report here Part 2, a twelve month prospective, open-label trial of VPA and L-carnitine in ambulatory SMA children. METHODS: This study involved 33 genetically proven type 3 SMA subjects ages 3-17 years. Subjects underwent two baseline assessments over 4-6 weeks and then were placed on VPA and L-carnitine for 12 months. Assessments were performed at baseline, 3, 6 and 12 months. Primary outcomes included safety, adverse events and the change at 6 and 12 months in motor function assessed using the Modified Hammersmith Functional Motor Scale Extend (MHFMS-Extend, timed motor tests and fine motor modules. Secondary outcomes included changes in ulnar compound muscle action potential amplitudes (CMAP, handheld dynamometry, pulmonary function, and Pediatric Quality of Life Inventory scores. RESULTS: Twenty-eight subjects completed the study. VPA and carnitine were generally well tolerated. Although adverse events occurred in 85% of subjects, they were usually mild and transient. Weight gain of 20% above body weight occurred in 17% of subjects. There was no significant change in any primary outcome at six or 12 months. Some pulmonary function measures showed improvement at one year as expected with normal growth. CMAP significantly improved suggesting a modest biologic effect not clinically meaningful. CONCLUSIONS: This study, coupled with the CARNIVAL Part 1 study, indicate that VPA is not effective in improving strength or function in SMA children. The outcomes used in this study are feasible and reliable, and can be employed in future trials in SMA. TRIAL REGSITRATION: Clinicaltrials.gov NCT00227266.

  12. Using ecological momentary assessment in testing the effectiveness of an alcohol intervention: a two-arm parallel group randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Carmen V Voogt

    Full Text Available BACKGROUND: Alcohol consumption of college students has a fluctuating nature, which might impact the measurement of intervention effects. By using 25 follow-up time-points, this study tested whether intervention effects are robust or might vary over time. METHODS: Data were used from a two-arm parallel group randomized controlled trial applying ecological momentary assessment (EMA with 30 data time-points in total. Students between 18 and 24 years old who reported heavy drinking in the past six months and who were ready to change their alcohol consumption were randomly assigned to the experimental (n = 456: web-based brief alcohol intervention and control condition (n = 451: no intervention. Outcome measures were weekly alcohol consumption, frequency of binge drinking, and heavy drinking status. RESULTS: According to the intention-to-treat principle, regression analyses revealed that intervention effects on alcohol consumption varied when exploring multiple follow-up time-points. Intervention effects were found for a weekly alcohol consumption at 1, 2, 3, 4, and 7 weeks follow-up, b frequency of binge drinking at 1, 2, 7, and 12 weeks follow-up, and c heavy drinking status at 1, 2, 7, and 16 weeks follow-up. CONCLUSIONS: This research showed that the commonly used one and six month follow-up time-points are relatively arbitrary and not using EMA might bring forth erroneous conclusions on the effectiveness of interventions. Therefore, future trials in alcohol prevention research and beyond are encouraged to apply EMA when assessing outcome measures and intervention effectiveness. TRIAL REGISTRATION: Netherlands Trial Register NTR2665.

  13. Efficacy and safety of bilateral continuous theta burst stimulation (cTBS for the treatment of chronic tinnitus: design of a three-armed randomized controlled trial

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    Plontke Stefan K

    2009-08-01

    Full Text Available Abstract Background Tinnitus, the perception of sound and noise in absence of an auditory stimulus, has been shown to be associated with maladaptive neuronal reorganization and increased activity of the temporoparietal cortex. Transient modulation of tinnitus by repetitive transcranial magnetic stimulation (rTMS indicated that these areas are critically involved in the pathophysiology of tinnitus and suggested new treatment strategies. However, the therapeutic efficacy of rTMS in tinnitus is still unclear, individual response is variable, and the optimal stimulation area disputable. Recently, continuous theta burst stimulation (cTBS has been put forward as an effective rTMS protocol for the reduction of pathologically enhanced cortical excitability. Methods 48 patients with chronic subjective tinnitus will be included in this randomized, placebo controlled, three-arm trial. The treatment consists of two trains of cTBS applied bilaterally to the secondary auditory cortex, the temporoparietal associaction cortex, or to the lower occiput (sham condition every working day for four weeks. Primary outcome measure is the change of tinnitus distress as quantified by the Tinnitus Questionnaire (TQ. Secondary outcome measures are tinnitus loudness and annoyance as well as tinnitus change during and after treatment. Audiologic and speech audiometric measurements will be performed to assess potential side effects. The aim of the present trail is to investigate effectiveness and safety of a four weeks cTBS treatment on chronic tinnitus and to compare two areas of stimulation. The results will contribute to clarify the therapeutic capacity of rTMS in tinnitus. Trial registration The trial was registered with the clinical trials register of http://www.clinicaltrials.gov (NCT00518024.

  14. Observational trial of safe food handling behavior during food preparation using the example of Campylobacter spp.

    Science.gov (United States)

    Hoelzl, C; Mayerhofer, U; Steininger, M; Brüller, W; Hofstädter, D; Aldrian, U

    2013-03-01

    Campylobacter infections are one of the most prominent worldwide food-related diseases. The primary cause of these infections is reported to be improper food handling, in particular cross-contamination during domestic preparation of raw chicken products. In the present study, food handling behaviors in Austria were surveyed and monitored, with special emphasis on Campylobacter cross-contamination. Forty participants (25 mothers or fathers with at least one child ≤10 years of age and 15 elderly persons ≥60 years of age) were observed during the preparation of a chicken salad (chicken slices plus lettuce, tomato, and cucumber) using a direct structured observational scoring system. The raw chicken carcasses and the vegetable part of the salad were analyzed for Campylobacter. A questionnaire concerning knowledge, attitudes, and interests related to food safety issues was filled out by the participants. Only 57% of formerly identified important hygiene measures were used by the participants. Deficits were found in effective hand washing after contact with raw chicken meat, but proper changing and cleaning of the cutting board was noted. Campylobacter was present in 80% of raw chicken carcasses, albeit the contamination rate was generally lower than the limit of quantification (10 CFU/g). In the vegetable part of the prepared product, no Campylobacter was found. This finding could be due to the rather low Campylobacter contamination rate in the raw materials and the participants' use of some important food handling behaviors to prevent cross-contamination. However, if the initial contamination had been higher, the monitored deficits in safe food handling could lead to quantifiable risks, as indicated in other published studies. The results of the observational trial and the questionnaire indicated knowledge gaps in the food safety sector, suggesting that further education of the population is needed to prevent the onset of foodborne diseases. PMID:23462086

  15. Does the use of Nintendo Wii Sports™ improve arm function and is it acceptable to patients after stroke? Publication of the Protocol of the Trial of Wii™ in Stroke – TWIST

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    Adie K

    2014-10-01

    Full Text Available Katja Adie,1 Christine Schofield,1 Margie Berrow,2 Jennifer Wingham,3 Janet Freeman,1 John Humfryes,1 Colin Pritchard3 1Royal Cornwall Hospital Trust, Cornwall, UK; 2Peninsula Clinical Trials Unit, Plymouth University Schools of Medicine and Dentistry, Plymouth, Devon, UK; 3Royal Cornwall Hospital, Truro, Cornwall, UKIntroduction: Many stroke patients experience loss of arm function requiring rehabilitation, which is expensive, repetitive, and does not always translate into “real life.” Nintendo Wii Sports™ (Wii™ may offer task-specific training that is repetitive and motivating. The Trial of Wii™ in Stroke (TWIST is designed to investigate feasibility, efficacy, and acceptability using Wii™ to improve affected arm function for patients after stroke.Method: This is a randomized controlled trial (RCT, incorporating a qualitative study and health economics analysis that compares playing Wii™ versus arm exercises in patients receiving standard rehabilitation in a home setting within 6 months of stroke with a motor deficit of less than 5 on the MRC (Medical Research Council scale (arm. In this study, we expect to randomize 240 participants.Outcome measures: Primary outcome is change in affected arm function at 6 weeks follow-up in intervention and control group using the Action Research Arm Test. Secondary outcomes include occupational performance using the Canadian Occupational Performance Measure, quality of life using the Stroke Impact Scale, cost effectiveness analysis, and a qualitative study investigating factors that influence use of Wii™ for patients and carers.Conclusion: TWIST is the first UK RCT assessing the feasibility, cost effectiveness, and acceptability of Wii™ in stroke rehabilitation. The trial has been registered with ISRCTN 06807619 and UK CRN 11030. Results of the study will be published after completion of study in August 2014.Keywords: virtual reality, rehabilitation

  16. Clinical trials with fast neutrons in Europe

    International Nuclear Information System (INIS)

    There is an increasing number of European centres with facilities for fast neutron treatment. To prepare protocols for multi-centre trials and to make treatment results intercomparable, many obstacles have to be overcome. A provision for two dose levels in the neutron treatment arm of a trial could enable the estimation of the local cure rate for an acceptable late complication rate. The considerations on which future trials are based as well as the main characteristics of trials in progress in Europe are reported. (author)

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

    OpenAIRE

    Daouda Sissoko; Cedric Laouenan; Elin Folkesson; Abdoul-Bing M'Lebing; Abdoul-Habib Beavogui; Sylvain Baize; Alseny-Modet Camara; Piet Maes; Susan Shepherd; Christine Danel; Sara Carazo; Conde, Mamoudou N.; Jean-Luc Gala; Géraldine Colin; Hélène Savini

    2016-01-01

    Ebola virus disease (EVD) is a highly lethal condition for which no specific treatment has proven efficacy. In September 2014, while the Ebola outbreak was at its peak, the World Health Organization released a short list of drugs suitable for EVD research. Favipiravir, an antiviral developed for the treatment of severe influenza, was one of these. In late 2014, the conditions for starting a randomized Ebola trial were not fulfilled for two reasons. One was the perception that, given the high ...

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

    Science.gov (United States)

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

    2016-01-01

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

  19. Adverse Events from a Randomized, Multi-Arm, Placebo-Controlled Trial of Mebendazole in Children 12-24 Months of Age.

    Science.gov (United States)

    Joseph, Serene A; Montresor, Antonio; Casapía, Martín; Pezo, Lidsky; Gyorkos, Theresa W

    2016-07-01

    Large-scale deworming interventions, using anthelminthic drugs, are recommended in areas where the prevalence of soil-transmitted helminth infection is high. Anthelminthic safety has been established primarily in school-age children. Our objective was to provide evidence on adverse events from anthelminthic use in early childhood. A randomized multi-arm, placebo-controlled trial of mebendazole, administered at different times and frequencies, was conducted in children 12 months of age living in Iquitos, Peru. Children were followed up to 24 months of age. The association between mebendazole administration and the occurrence of a serious or minor adverse event was determined using logistic regression. There was a total of 1,686 administrations of mebendazole and 1,676 administrations of placebo to 1,760 children. Eighteen serious adverse events (i.e., 11 deaths and seven hospitalizations) and 31 minor adverse events were reported. There was no association between mebendazole and the occurrence of a serious adverse event (odds ratio [OR] = 1.21; 95% confidence interval [CI] = 0.47, 3.09) or a minor adverse event (OR = 0.84; 95% CI = 0.41, 1.72). Results from our trial support evidence of safety in administering mebendazole during early childhood. These results support World Health Organization deworming policy and the scaling up of interventions to reach children as of 12 months of age in endemic areas. PMID:27139441

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

    Directory of Open Access Journals (Sweden)

    Daouda Sissoko

    2016-03-01

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

  1. Preliminary evidence for cell membrane amelioration in children with cystic fibrosis by 5-MTHF and vitamin B12 supplementation: a single arm trial.

    Directory of Open Access Journals (Sweden)

    Cinzia Scambi

    Full Text Available BACKGROUND: Cystic fibrosis (CF is one of the most common fatal autosomal recessive disorders in the Caucasian population caused by mutations of gene for the cystic fibrosis transmembrane conductance regulator (CFTR. New experimental therapeutic strategies for CF propose a diet supplementation to affect the plasma membrane fluidity and to modulate amplified inflammatory response. The objective of this study was to evaluate the efficacy of 5-methyltetrahydrofolate (5-MTHF and vitamin B12 supplementation for ameliorating cell plasma membrane features in pediatric patients with cystic fibrosis. METHODOLOGY AND PRINCIPAL FINDINGS: A single arm trial was conducted from April 2004 to March 2006 in an Italian CF care centre. 31 children with CF aged from 3 to 8 years old were enrolled. Exclusion criteria were diabetes, chronic infections of the airways and regular antibiotics intake. Children with CF were supplemented for 24 weeks with 5-methyltetrahydrofolate (5-MTHF, 7.5 mg /day and vitamin B12 (0.5 mg/day. Red blood cells (RBCs were used to investigate plasma membrane, since RBCs share lipid, protein composition and organization with other cell types. We evaluated RBCs membrane lipid composition, membrane protein oxidative damage, cation content, cation transport pathways, plasma and RBCs folate levels and plasma homocysteine levels at baseline and after 24 weeks of 5-MTHF and vitamin B12 supplementation. In CF children, 5-MTHF and vitamin B12 supplementation (i increased plasma and RBC folate levels; (ii decreased plasma homocysteine levels; (iii modified RBC membrane phospholipid fatty acid composition; (iv increased RBC K(+ content; (v reduced RBC membrane oxidative damage and HSP70 membrane association. CONCLUSION AND SIGNIFICANCE: 5-MTHF and vitamin B12 supplementation might ameliorate RBC membrane features of children with CF. TRIAL REGISTRATION: ClinicalTrials.gov NCT00730509.

  2. Impact of NGO training and support intervention on diarrhoea management practices in a rural community of Bangladesh: an uncontrolled, single-arm trial.

    Directory of Open Access Journals (Sweden)

    Ahmed S Rahman

    Full Text Available PURPOSE/OBJECTIVE: The evolving Non-Governmental Organization (NGO sector in Bangladesh provides health services directly, however some NGOs indirectly provide services by working with unlicensed providers. The primary objective of this study was to examine the impact of NGO training of unlicensed providers on diarrhoea management and the scale up of zinc treatment in rural populations. METHODS: An uncontrolled, single-arm trial for a training and support intervention on diarrhoea outcomes was employed in a rural sub-district of Bangladesh during 2008. Two local NGOs and their catchment populations were chosen for the study. The intervention included training of unlicensed health care providers in the management of acute childhood diarrhoea, particularly emphasizing zinc treatment. In addition, community-based promotion of zinc treatment was carried out. Baseline and endline ecologic surveys were carried out in intervention and control villages to document changes in treatments received for diarrhoea in under-five children. RESULTS: Among surveyed household with an active or recent acute childhood diarrhoea episode, 69% sought help from a health provider. Among these, 62.8% visited an unlicensed private provider. At baseline, 23.9% vs. 22% of control and intervention group children with diarrhoea had received zinc of any type. At endline (6 months later this had changed to 15.3% vs. 30.2%, respectively. The change in zinc coverage was significantly higher in the intervention villages (p<0.01. Adherence with giving zinc for 10 days or more was significantly higher in the intervention households (9.2% vs. 2.5%; p<0.01. Child's age, duration of diarrhoea, type of diarrhoea, parental year of schooling as well as oral rehydration solution (ORS and antibiotic usage were significant predictors of zinc usage. CONCLUSION: Training of unlicensed healthcare providers through NGOs increased zinc coverage in the diarrhoea management of under-five children in

  3. Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN)

    Science.gov (United States)

    Griffin, D R; Dickenson, E J; Wall, P D H; Donovan, J L; Foster, N E; Hutchinson, C E; Parsons, N; Petrou, S; Realpe, A; Achten, J; Achana, F; Adams, A; Costa, M L; Griffin, J; Hobson, R; Smith, J

    2016-01-01

    Introduction Femoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome. Methods We will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02). Ethics and dissemination Ethical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer

  4. Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Four-Arm Randomized Trial on the Effectiveness of Electroacupuncture

    Directory of Open Access Journals (Sweden)

    M. Rostock

    2013-01-01

    Full Text Available Purpose. Chemotherapy-induced peripheral neuropathy (CIPN is a common and dose-limiting side effect of cytostatic drugs. Since there are no proven therapeutic procedures against CIPN, we were interested to define the role of electroacupuncture (EA from which preliminary data showed promising results. Methods. In a randomized trial with a group sequential adaptive design in patients with CIPN, we compared EA (LV3, SP9, GB41, GB34, LI4, LI11, SI3, and HT3; n=14 with hydroelectric baths (HB, n=14, vitamin B1/B6 capsules (300/300 mg daily; VitB, n=15, and placebo capsules (n=17. The statistical power in this trial was primarily calculated for proving EA only, so results of HB and VitB are pilot data. Results. CIPN complaints improved by 0.8±1.2 (EA, 1.7±1.7 (HB, 1.6±2.0 (VitB, and 1.3±1.3 points (placebo on a 10-point numeric rating scale without significant difference between treatment groups or placebo. In addition no significant differences in sensory nerve conduction studies or quality of life (EORTC QLQ-C30 were found. Conclusions. The used EA concept, HB, and VitB were not superior to placebo. Since, contrary to our results, studies with different acupuncture concepts showed a positive effect on CIPN, the effect of acupuncture on CIPN remains unclear. Further randomized, placebo controlled studies seem necessary. This trial is registered with DRKS00004448.

  5. Web-based screening and brief intervention for poly-drug use among teenagers: study protocol of a multicentre two-arm randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Arnaud Nicolas

    2012-09-01

    Full Text Available Abstract Background Mid to late adolescence is characterised by a vulnerability to problematic substance use since the consumption of alcohol and illicit drugs is frequently initiated and increased in this life period. While the detrimental long- and short-term effects of problematic consumption patterns in adolescence pose a major public health concern, current prevention programs targeting alcohol- and other substance-using adolescents are scarce. The study described in this protocol will test the effectiveness of a web-based brief intervention aimed at reducing problematic alcohol use and promoting abstinence from illegal drugs in adolescents with risky substance use aged 16 to 18 years old in four EU-countries. Methods/design To determine the effectiveness of our web-BI, we apply a two-arm randomized controlled trial (RCT study design, with baseline assessment at study entry and a three month follow-up assessment. Adolescents aged 16 to 18 years from Belgium, the Czech Republic, Germany, and Sweden will be randomly assigned to either the fully electronically delivered brief intervention group (N = 400 or an assessment only control group (N = 400 depending on their screening for risky substance use (using the CRAFFT. Recruitment, informed consent, randomization, intervention and follow-up will be implemented online. Primary outcomes are reductions in frequency and quantity of use of alcohol and drugs other than alcohol over a 30 day period, as well as consumption per typical occasion. Secondary outcomes concern changes in substance use related cognitions including the constructs of the Theory of Planned Behaviour, implementation intentions, and stages of change. Moreover the study addresses a number of moderator variables, including age of first use, general psychopathology and quality of parent–child relationship. Discussion The trial is expected to contribute to the growing literature on theory- and web-based brief interventions

  6. Hydrogel Dressing Prepared From PVA/PVP/KC/CMC By Gamma Irradiation And Some Results Of Pre-Clinical Trial

    International Nuclear Information System (INIS)

    Hydrogel dressings were prepared from polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), kappa carrageenan (KC) and carboxymethyl chitosan (CMC) by gamma irradiation. The characteristics of prepared hydrogel dressing are suitable for covering and healing burn/wound of skin. The obtained results of pre-clinical trials showed that hydrogel dressing did not cause skin irritation, the healing time of the third-degree burn covered hydrogel dressing was faster than 5 days to compared the burn covered pool-oil soaked gauze. The healing process of the burned skin area was estimated in pictorial histology. (author)

  7. A Parallel-Arm Randomized Controlled Trial to Assess the Effects of a Far-Infrared-Emitting Collar on Neck Disorder

    Directory of Open Access Journals (Sweden)

    Yung-Sheng Lin

    2015-09-01

    Full Text Available The purpose of this study is to assess the beneficial effects of a far-infrared-emitting collar (FIRC on the management of neck disorders. A neck disorder is generalized as neck muscle pain and its relative mental disorders because the etiologies of the neck’s multidimensional syndrome are either muscle impairment or psychiatric distress. This is the first study to determine the efficacy of a FIRC by evaluating objective physical evidence and psychometric self-reports using a parallel-arm randomized sham-controlled and single-blinded design. In this trial, 60 participants with neck disorders were observed at baseline and post-intervention. Compared to the placebo group after a 30-min intervention, the FIRC demonstrated a statistically significant biological effect in elevating skin temperature and promoting blood circulation with p-values 0.003 and 0.020, respectively. In addition, FIRC application significantly reduced neck muscle tension, relieved pain, ameliorated fatigue, improved depression, and decreased anxiety. The FIRC could therefore be a potential treatment for neck disorders.

  8. Does the use of Nintendo Wii Sports™ improve arm function and is it acceptable to patients after stroke? Publication of the Protocol of the Trial of Wii™ in Stroke – TWIST

    OpenAIRE

    Adie, Katja

    2014-01-01

    Katja Adie,1 Christine Schofield,1 Margie Berrow,2 Jennifer Wingham,3 Janet Freeman,1 John Humfryes,1 Colin Pritchard3 1Royal Cornwall Hospital Trust, Cornwall, UK; 2Peninsula Clinical Trials Unit, Plymouth University Schools of Medicine and Dentistry, Plymouth, Devon, UK; 3Royal Cornwall Hospital, Truro, Cornwall, UKIntroduction: Many stroke patients experience loss of arm function requiring rehabilitation, which is expensive, repetitive, and does not always translate into “real li...

  9. Oral and parenteral pyridostigmine in preparing Myasthenia Gravis patients for thymectomy;a randomized Clinical trial

    Directory of Open Access Journals (Sweden)

    Tadjeddein A

    2007-06-01

    Full Text Available Background: Respiratory failure and crisis is one of major complications of thymectomy in myasthenia gravis patients. There are different medication regimes for preparing these patients for surgery and reducing post-operative side effects. The goal of this study is to compare respiratory complications of oral vs. Parenteral preoperative administration of anticholinesterase agents for thymectomy in myasthenia gravis patients. Methods: This randomized controlled trial included 101 patients in class IIA or IIB of myasthenia gravis according to the Osserman classification system. The control group fasted for eight hours before surgery and oral anticholines-terase agents were replaced with parenteral ones. The case group also fasted for 8 hours before surgery, but pyridostigmine was continued at its usual dose until the time of operation and the last dose was given to patients with a small amount of water in the operating room on the operating bed. Results: There was no statistically meaningful difference between the two groups in terms of age, sex and pathologic findings. In comparison, the mean hospital stay for the case group was 3.98 days and 6.34 for the control group (p value = 0.003. There were eight cases of respiratory crisis or failure (16% in the control group but only 1 case (2% was observed in case group (p value = 0.014. Only one patient in the case group required re-intubation after the surgery; however, six patients in control group were re-intubated (p value = 0.053. Plasmapheresis was required for five patients in the control group and one patient in the case group (p value = 0.098. Tracheostomy was performed on two patients in the control group to accommodate prolonged intubation, but none of the case group required this procedure. Conclusion: This study shows that continuing oral anticholinesterase agents up to the time of operation, with the last dose at the operative theater, lowers the incidence of post-operative myasthenia

  10. Clinical Trials Legislation - preparing for the revision of the European Directive Scheduled for 2011.

    Science.gov (United States)

    Bilbault, Pascal; Belorgey, Chantal; Zannad, Faiez; Golinelli, Danielle; Pletan, Yannick

    2010-01-01

    The aim of the Round Table was to make recommendations with regard to the imminent revision of the European Directive on clinical drug trials (2001/20/CE). While recognising the importance of compliance with this Directive, which is not optimal in some member states of the European Union, it would be constructive to simplify further and harmonise its application in every country. Without necessarily resorting to a revision, some of the Directive's dispositions could be improved, such as the definition of "investigational medicinal products" (IMP) and what should be considered as "substantial amendements", as well as harmonising and improving the way in which Ethics Committees are run, either on a European Commission level, or by relying more on the European Network of Research Ethics Committees (EUREC) which already exists in several European member states. Other points in the Directive do require revision, especially those relating to: the definition of the respective roles of Ethics Committees and Competent Authorities, the simplification of safety information to Ethics Committees (giving them access to the Eudravigilance database for adverse reactions occurring during clinical trials and providing them with only new safety issues or with a summary of the Annual Safety Report), the possibility of one single European authorisation for the trial, centralised and/or decentralised, when the trial is multinational. The recommended changes could be made within the scope of a European Regulation, avoiding the need to transpose it at a later date into each country's regulations, which is a source of possible lack of harmonisation. More specifically, for trials with institutional sponsors and/or investigator driven trials such as "drug therapy strategy trials", modulating restrictions according to the "risk added by the research" would enable the trial's organisation to be simplified regarding monitoring, adverse reactions reporting and study drugs labelling. PMID

  11. The reduction of disability in community-dwelling frail older people: design of a two-arm cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Metzelthin Silke F

    2010-08-01

    Full Text Available Abstract Background Frailty among older people is related to an increased risk of adverse health outcomes such as acute and chronic diseases, disability and mortality. Although many intervention studies for frail older people have been reported, only a few have shown positive effects regarding disability prevention. This article presents the design of a two-arm cluster randomized controlled trial on the effectiveness, cost-effectiveness and feasibility of a primary care intervention that combines the most promising elements of disability prevention in community-dwelling frail older people. Methods/design In this study twelve general practitioner practices were randomly allocated to the intervention group (6 practices or to the control group (6 practices. Three thousand four hundred ninety-eight screening questionnaires including the Groningen Frailty Indicator (GFI were sent out to identify frail older people. Based on their GFI score (≥5, 360 participants will be included in the study. The intervention will receive an interdisciplinary primary care intervention. After a comprehensive assessment by a practice nurse and additional assessments by other professionals, if needed, an individual action plan will be defined. The action plan is related to a flexible toolbox of interventions, which will be conducted by an interdisciplinary team. Effects of the intervention, both for the frail older people and their informal caregivers, will be measured after 6, 12 and 24 months using postal questionnaires and telephone interviews. Data for the process evaluation and economic evaluation will be gathered continuously over a 24-month period. Discussion The proposed study will provide information about the usefulness of an interdisciplinary primary care intervention. The postal screening procedure was conducted in two cycles between December 2009 and April 2010 and turned out to be a feasible method. The response rate was 79.7%. According to GFI scores 29

  12. Novel 4-Arm Poly(Ethylene Glycol)-Block-Poly(Anhydride-Esters) Amphiphilic Copolymer Micelles Loading Curcumin: Preparation, Characterization, and In Vitro Evaluation

    OpenAIRE

    Li Lv; Yuanyuan Shen; Min Li; Xiaofen Xu; Mingna Li; Shengrong Guo; Shengtang Huang

    2013-01-01

    A novel 4-arm poly(ethylene glycol)-block-poly(anhydride-esters) amphiphilic copolymer (4-arm PEG-b-PAE) was synthesized by esterization of 4-arm poly(ethylene glycol) and poly(anhydride-esters) which was obtained by melt polycondensation of α -, ω -acetic anhydride terminated poly(L-lactic acid). The obtained 4-arm PEG-b-PAE was characterized by 1H-NMR and gel permeation chromatography. The critical micelle concentration of 4-arm PEG-b-PAE was 2.38  μ g/mL. The curcumin-loaded 4-arm PEG-b-PA...

  13. Efficacy of a Multi-level Intervention to Reduce Injecting and Sexual Risk Behaviors among HIV-Infected People Who Inject Drugs in Vietnam: A Four-Arm Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Vivian F Go

    Full Text Available Injecting drug use is a primary driver of HIV epidemics in many countries. People who inject drugs (PWID and are HIV infected are often doubly stigmatized and many encounter difficulties reducing risk behaviors. Prevention interventions for HIV-infected PWID that provide enhanced support at the individual, family, and community level to facilitate risk-reduction are needed.455 HIV-infected PWID and 355 of their HIV negative injecting network members living in 32 sub-districts in Thai Nguyen Province were enrolled. We conducted a two-stage randomization: First, sub-districts were randomized to either a community video screening and house-to-house visits or standard of care educational pamphlets. Second, within each sub-district, participants were randomized to receive either enhanced individual level post-test counseling and group support sessions or standard of care HIV testing and counseling. This resulted in four arms: 1 standard of care; 2 community level intervention; 3 individual level intervention; and 4 community plus individual intervention. Follow-up was conducted at 6, 12, 18, and 24 months. Primary outcomes were self-reported HIV injecting and sexual risk behaviors. Secondary outcomes included HIV incidence among HIV negative network members.Fewer participants reported sharing injecting equipment and unprotected sex from baseline to 24 months in all arms (77% to 4% and 24% to 5% respectively. There were no significant differences at the 24-month visit among the 4 arms (Wald = 3.40 (3 df; p = 0.33; Wald = 6.73 (3 df; p = 0.08. There were a total of 4 HIV seroconversions over 24 months with no significant difference between intervention and control arms.Understanding the mechanisms through which all arms, particularly the control arm, demonstrated both low risk behaviors and low HIV incidence has important implications for policy and prevention programming.ClinicalTrials.gov NCT01689545.

  14. Differences in Patient Outcomes of Prevalence, Interval, and Screen-Detected Lung Cancers in the CT Arm of the National Lung Screening Trial

    Science.gov (United States)

    Massion, Pierre P.; Thompson, Zachary J.; Eschrich, Steven A.; Balagurunathan, Yoganand; Goldof, Dmitry; Aberle, Denise R.; Gillies, Robert J.

    2016-01-01

    Lung cancer screening identifies cancers with heterogeneous behaviors. Some lung cancers will be identified among patients who had prior negative CT screens and upon follow-up scans develop a de novo nodule that was determined to be cancerous. Other lung cancers will be identified among patients who had one or more prior stable positive scans that were not determined to be lung cancer (indeterminate pulmonary nodules), but in follow-up scans was diagnosed with an incidence lung cancer. Using data from the CT arm of the National Lung Screening Trial, this analysis investigated differences in patient characteristics and survival endpoints between prevalence-, interval-, and screen-detected lung cancers, characterized based on sequence of screening results. Lung cancers immediately following a positive baseline (T0), and prior to the T1 screen, formed the prevalence cohort. Interval cancers were diagnosed following a negative screen at any time point prior to the next screening round. Two cohorts of screen-detected lung cancers (SDLC) were identified that had a baseline positive screen that was that was not determined to be lung cancer (i.e., an indeterminate pulmonary nodule), but in follow-up scans was diagnosed with an incidence lung cancer 12 (SDLC1) or 24 (SDLC2) months later. Two other incidence cohorts had screen-detected lung cancers that had baseline negative screen and upon follow-up scans developed a de novo nodule determined to be cancerous at 12 (SDLC3) or 24 (SDLC4) months later. Differences in patient characteristics, progression-free survival (PFS), and overall survival (OS) were assessed. The lung cancer-specific death rate was higher for SDLC3/SDLC4 compared to SDLC1/SDLC2 lung cancers (136.6/1,000 person-years vs. 71.3/1,000 person-years, P lung cancers (HR = 1.00). Lung cancer patients who develop a de novo nodule that determined to be cancerous (i.e., at least one negative CT screen prior to cancer diagnosis) had poorer survival outcomes compared

  15. Immunotherapeutic trials with auto-vaccine prepared from head and neck malignancy

    International Nuclear Information System (INIS)

    The cancer of the oral cavity is one of the commonly occurring cancers in India. The long term survivals are very few in spite of multiple modalities and therapeutic trials especially in inoperable advanced cases which can not be treated with conventional therapy. Efforts were therefore made to immunize such patients with autochthonous irradiated cell vaccine to trigger their innate and acquired defence. The immune status of the individual patient and their serum immunoglobulins were estimated before and after the course of vaccine. Slight or moderate improvements were observed in few cases. (author)

  16. Preparing for microbicide trials in Rwanda: Focus group discussions with Rwandan women and men

    NARCIS (Netherlands)

    N. Veldhuijzen; J. Nyinawabega; M. Umulisa; B. Kankindi; E. Geubbels; P. Basinga; J. Vyankandondera; J. van de Wijgert

    2006-01-01

    The acceptability and feasibility of microbicide studies and future microbicide use are influenced by existing norms and values regarding sexual and contraceptive behaviour. In preparation for microbicide research in Rwanda, focus group discussions were conducted to assess sexual and contraceptive b

  17. Lavender-thymol as a new topical aromatherapy preparation for episiotomy: A randomised clinical trial.

    Science.gov (United States)

    Marzouk, T; Barakat, R; Ragab, A; Badria, F; Badawy, A

    2015-01-01

    The objective of this study was to evaluate the effectiveness of topical lavender-thymol in promoting episiotomy healing. This placebo-controlled, single-blinded, randomised clinical trial involved 60 primiparous women. REEDA score was used to evaluate the outcome of the trial. On the 7th post-partum day, women in Placebo-treated group had worse Redness, Edema, Ecchymosis, Discharge and Approximation (REEDA) score of 3.93 ± 3.65 compared with those in Lavender-thymol-treated group (2.03 ± 1.7) with significant difference (P = 0.013). Visual analogue Scale (VAS) score for pain at episiotomy in Lavender-thymol-treated group was 3.5 ± 1.9, whereas in Placebo-treated group it was 2.1 ± 2.2 (p = 0.011) for dyschezia, 3.8 ± 1.7 and 2.8 ± 1.6 in Placebo- and Lavender-thymol-treated women, respectively (p = 0.023). At 7th post-partum week, dyspareunia was more severe in Placebo-treated group compared with that in Lavender-thymol-treated group (5.3 ± 2.7 vs 2.7 ± 1.5 and p aromatherapy using lavender-thymol was highly effective, suitable and safe for episiotomy wound care with little or no expected side effects compared with that using placebo. PMID:25384116

  18. BNCT enhanced fast neutron therapy: in vitro studies for preparing a clinical trial at the Essen cyclotron

    International Nuclear Information System (INIS)

    At the University Hospital Essen a cyclotron producing d(14)+Be fast neutrons is used routinely for patient treatment. Fast neutrons have demonstrated their potential to sterilize glioblastoma but could not show a clinical benefit because of lethal damages to healthy brain. At depth, fast neutrons are thermalized allowing neutron capture reactions, which can be used to enhance the applied dose. A selective increase of the dose to the tumor cells by BNCT may offer a chance to an effective treatment. In order to prepare a clinical trial in vitro experiments were performed. MeWo cells were irradiated in a tissue equivalent phantom at a depth of 6.5 cm. 91% 10B enriched BSH was used to generate BNC effects. For a total dose of 1 Gy the thermal fluence rate was 3.4x1010 cm-2. An amount of 960 ppm 10B present in the cell medium during irradiation led to a reduction of the cell survival from 3.6% (neutron alone) to 0.2%. If the irradiation was performed after incubation of the cells in BSH, but in a medium without BSH the survival was 1.6%. The in vitro set up demonstrates the capacity of BSH to considerably increase the biological effects of the neutron irradiation and add arguments for the opening of a clinical trial. (author)

  19. Robotic arm

    Science.gov (United States)

    Kwech, Horst

    1989-04-18

    A robotic arm positionable within a nuclear vessel by access through a small diameter opening and having a mounting tube supported within the vessel and mounting a plurality of arm sections for movement lengthwise of the mounting tube as well as for movement out of a window provided in the wall of the mounting tube. An end effector, such as a grinding head or welding element, at an operating end of the robotic arm, can be located and operated within the nuclear vessel through movement derived from six different axes of motion provided by mounting and drive connections between arm sections of the robotic arm. The movements are achieved by operation of remotely-controllable servo motors, all of which are mounted at a control end of the robotic arm to be outside the nuclear vessel.

  20. Robotic arm

    International Nuclear Information System (INIS)

    A robotic arm positionable within a nuclear vessel by access through a small diameter opening and having a mounting tube supported within the vessel and mounting a plurality of arm sections for movement lengthwise of the mounting tube as well as for movement out of a window provided in the wall of the mounting tube is disclosed. An end effector, such as a grinding head or welding element, at an operating end of the robotic arm, can be located and operated within the nuclear vessel through movement derived from six different axes of motion provided by mounting and drive connections between arm sections of the robotic arm. The movements are achieved by operation of remotely-controllable servo motors, all of which are mounted at a control end of the robotic arm to be outside the nuclear vessel. 23 figs

  1. A trial preparation of phantom for use in both x-ray computed tomography and ultrasonography

    International Nuclear Information System (INIS)

    Effective clinical diagnosis by XCT and US may be assisted by prior evaluation of basic data with an experimental phantom that can be used in both XCT and US. This paper describes a phantom prepared for this purpose. Materials are warm water, gelatine powder, powder soap (containing 98% surface active agent) and salad oil. Table 1 shows the recipe. Gelatine powder is first dissolved in warm water, to which powder soap and salad oil are added. After sufficient stirring, the mixture is placed into a vessel and allowed to stand 24 hours for solidification. (author)

  2. 卟啉四臂星型聚乳酸的制备与表征%PREPARATION AND CHARACTERIZATION OF FOUR ARMED STAR POLYLACTIC ACID WITH PORPHYRIN CORE

    Institute of Scientific and Technical Information of China (English)

    李建忠; 姜飞; 万晓波

    2012-01-01

    利用本体聚合方法,采用辛酸亚锡为催化剂,四氨基苯基卟啉为引发剂,引发丙交酯开环聚合,制备四臂星型聚乳酸功能高分子材料.采用1 H-NMR,FTIR,GPC等对星型聚合物的分子结构、分子量及其分布等进行了研究.利用溶液浇铸成膜方法,制备了聚乳酸薄膜材料;并利用XRD方法,研究了聚乳酸薄膜的结构.研究表明,利用四氨基苯基卟啉为引发剂,合成了以卟啉为核的四臂星型聚合物,其溶液浇铸薄膜具有正交晶系α晶型结构,而线型聚乳酸呈非晶态结构.利用紫外可见吸收光谱研究了星型聚乳酸的光谱性质,结果表明合成聚合物具有锡卟啉的光学特性.%Star poly (lactic acid) was successfully synthesized via bulk ring opening polymerization of lactide using meso-tetra(p-aminophenyl) porphyrin (TAPP)as initiator and stannous octanoate (Sn(Oct)2)as catalyst under vacuum. Molecular structure of the four armed poly ( lactic acid) was characterized via H-NMR and FTIR. It was confirmed that the star poly (lactic acid) was comprised with four-armed polymer chain and a tin porphyrin core. The molecular weight was also studied via GPC and H-NMR,and molecular weight distribution was also characterized (Mw/Mn =1.97). Both star poly (lactic acid) film and linear poly (lactic acid) film were prepared using solution-casting method. Structural analysis via X-ray diffraction indicates that the star poly (lactic acid) films display the orthorhombic α-crystalline form, while linear poly (lactic acid) films display amorphous structure. The photoelectron study of the functional poly (lactic acid) via UV-Vis absorption spectra reveals that the star poly (lactic acid) displays photoelectric property of tin porphyrin.

  3. Effect of 635nm Low-level Laser Therapy on Upper Arm Circumference Reduction: A Double-blind, Randomized, Sham-controlled Trial

    OpenAIRE

    Nestor, Mark S.; Zarraga, Matthew B.; Park, Hyunhee

    2012-01-01

    Objective: To assess the safety and efficacy of low-level laser therapy as a noninvasive method for reducing upper arm circumference. Design: Randomized, double-blind study whereby healthy subjects (N=40) with a body mass index of 20 to 35kg/m2 received three 20-minute low-level laser therapy (N=20) or sham treatments (N=20) each week for two weeks. Measurements: Upper arm circumference was measured after three and six treatments and two weeks post-treatment. Primary success criterion was the...

  4. Effectiveness of a Chinese herbal medicine preparation in the treatment of cough in uncomplicated upper respiratory tract infection: a randomised double-blinded placebo-control trial

    OpenAIRE

    WCW, Wong; A, Lee; AT, Lam; KT, Li; CYM, Leung; PC, Leung; ELY, Wong; JL, Tang

    2006-01-01

    Background Rigorous scientific and well-designed clinical trials to evaluate the effect of traditional Chinese medicine (TCM) is lacking. We, therefore, designed this study to evaluate the effectiveness of a commonly used TCM preparation in treating acute cough of uncomplicated URTI in adults and to search for a safe, effective and affordable alternative treatment for this common condition. Methods A randomised, double-blinded, placebo-control study comparing this TCM preparation with a place...

  5. Study on methyl iodide prepared without acute toxicant and its trial application in iodine adsorber test

    International Nuclear Information System (INIS)

    This paper studied a method of substitution, which substituted the non-toxic chlorotrimethylsilane (Me3SiCl) /sodium iodide (NaI) for the acutely toxic dimethyl sulphate (DMS) as a dealkylating agent for the first time to react with phosphate methylesters in preparing the gaseous radioactive methyl iodide. Comparative tests were carried out between substitution method and DMS method to measure respective cleaning efficiencies of iodine absorber both in lab and in the ventilation system of nuclear power plant. The impact of the substitutes on the organic material components of methyl iodide generator was also evaluated. The results showed that the substitution method was comparable to the former DMS method, and the substitutes was also compatible with the generator. Therefore, the substitution method can be preliminary judged applicable to both workshop and in-place tests of iodine adsorber in nuclear power plants. (authors)

  6. Using Ecological Momentary Assessment in Testing the Effectiveness of an Alcohol Intervention: A Two-Arm Parallel Group Randomized Controlled Trial

    NARCIS (Netherlands)

    Voogt, C.V.; Kuntsche, E.N.; Kleinjan, M.; Poelen, E.A.P.; Lemmers, A.C.J.; Engels, R.C.M.E.

    2013-01-01

    Background Alcohol consumption of college students has a fluctuating nature, which might impact the measurement of intervention effects. By using 25 follow-up time-points, this study tested whether intervention effects are robust or might vary over time. Methods Data were used from a two-arm paralle

  7. Efficacy of an internet-based self-help intervention to reduce co-occurring alcohol misuse and depression symptoms in adults: study protocol of a three-arm randomised controlled trial

    Science.gov (United States)

    Schaub, Michael P; Blankers, Matthijs; Lehr, Dirk; Boss, Leif; Riper, Heleen; Dekker, Jack; Goudriaan, Anna E; Maier, Larissa J; Haug, Severin; Amann, Manuel; Dey, Michelle; Wenger, Andreas; Ebert, David D

    2016-01-01

    Introduction In the general population, alcohol use disorder and depression more often occur together than any other combination of a mental illness with a substance use disorder. It is important to have a cost-effective intervention that is able to reach at-risk individuals in the early stages of developing alcohol use disorders and depression disorders. Methods and analysis This paper presents the protocol for a 3-arm multicentre randomised controlled trial (RCT) to test the efficacy and cost-effectiveness of the combined internet-based self-help intervention Take Care of You (TCOY) to reduce alcohol misuse and depression symptoms in comparison with a waiting list control group and a comparable intervention focusing on problematic alcohol use only. The active interventions consist of modules designed to reduce alcohol use, based on the principles of motivational interviewing and methods of cognitive behavioural therapy, together with additional modules in the combined study arm to reduce symptoms of depression. Data will be collected at baseline, as well as at 3 and 6 months postrandomisation. The primary outcome is the quantity of alcohol used in the past 7 days. A number of secondary outcome measures will be studied. These include the Centre of Epidemiologic Studies of Depression Scale (CES-D) and a combined measure with the criteria of values below the cut-off for severe alcohol use disorder and for CES-D. Data analysis will follow the intention-to-treat principle using (generalised) linear mixed models. In order to investigate the interventions’ cost-utility and cost-effectiveness, a full economic evaluation will be performed. Ethics and dissemination This RCT will be executed in compliance with the Helsinki Declaration and has been approved by 2 local Ethics Committees. Results will be reported at conferences and in peer-reviewed publications. Participant-friendly summaries of trial findings will be published on the TCOY websites. Trial registration

  8. A comparison of a new multinomial stopping rule with stopping rules of fleming and gehan in single arm phase II cancer clinical trials

    Directory of Open Access Journals (Sweden)

    Tu Dongsheng

    2011-06-01

    Full Text Available Abstract Background Response rate (RR alone may be insensitive to drug activity in phase II trials. Early progressive disease (EPD could improve sensitivity as well as increase stage I stopping rates. This study compares the previously developed dual endpoint stopping rule (DESR, which incorporates both RR and EPD into a two-stage, phase II trial, with rules using only RR. Methods Stopping rules according to the DESR were compared with studies conducted under the Fleming (16 trials or Gehan (23 trials designs. The RR hypothesis for the DESR was consistent with the comparison studies (ralt = 0.2, rnul = 0.05. Two parameter sets were used for EPD rates of interest and disinterest respectively (epdalt, epdnul: (0.4, 0.6 and (0.3, 0.5. Results Compared with Fleming, the DESR was more likely to allow stage two of accrual and to reject the null hypothesis (Hnul after stage two, with rejection being more common with EPD parameters (0.4, 0.6 than (0.3, 0.5. Compared with Gehan, both DESR parameter sets accepted Hnul in 15 trials after stage I compared with 8 trials by Gehan, with consistent conclusions in all 23 trials after stage II. Conclusions The DESR may reject Hnul when EPD rates alone are low, and thereby may improve phase II trial sensitivity to active, cytostatic drugs having limited response rates. Conversely, the DESR may invoke early stopping when response rates are low and EPD rates are high, thus shortening trials when drug activity is unlikely. EPD parameters should be chosen specific to each trial.

  9. A three-arm randomised controlled trial comparing Gonadotrophin Releasing Hormone (GnRH agonist long regimen versus GnRH agonist short regimen versus GnRH antagonist regimen in women with a history of poor ovarian response undergoing in vitro fertilisation (IVF treatment: Poor responders intervention trial (PRINT

    Directory of Open Access Journals (Sweden)

    Braude Peter

    2007-12-01

    Full Text Available Abstract Background Poor response to ovarian stimulation with exogenous gonadotrophins occurs in 9–24% of women undergoing in vitro fertilisation (IVF treatment, which represents an estimated 4000–10,000 women per year in the UK. Poor responders often have their treatment cycle cancelled because of expected poor outcome. One treatment strategy that may influence outcome is the choice of pituitary suppression regimen prior to the initiation of ovarian stimulation. The three commonly used pituitary suppression regimens in IVF treatment are: (1 the GnRH agonist long regimen, (2 the GnRH agonist short regimen and (3 the GnRH antagonist regimen. A systematic review of randomised controlled trials of these pituitary suppression regimens has shown the evidence to be either inconclusive or inconsistent. We therefore designed a three arm randomised trial to evaluate the effectiveness of these regimens in women who had poor ovarian response in a previous IVF treatment cycle. Methods/design Consenting, eligible women will be randomised to one of the three regimens using an internet-based trial management programme that ensures allocation concealment and employs block randomisation and minimisation for prognostic variables. The primary outcome is the number of oocytes retrieved. Other outcomes include total dose of follicle stimulating hormone (FSH used for ovarian stimulation, mature oocytes retrieved, embryos available for transfer, implantation rate and clinical pregnancy rate. The sample size for this trial has been estimated as 102 participants with 34 participants in each of the three arms. Appropriate interim analysis will be conducted by a Data Monitoring and Ethics Committee (DMEC, and the final analysis will be by intention to treat. Trial registration ISRCTN27044628

  10. Targeting young drinkers online: the effectiveness of a web-based brief alcohol intervention in reducing heavy drinking among college students: study protocol of a two-arm parallel group randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lemmers Lex ACJ

    2011-04-01

    Full Text Available Abstract Background The prevalence of heavy drinking among college students and its associated health related consequences highlights an urgent need for alcohol prevention programs targeting 18 to 24 year olds. Nevertheless, current alcohol prevention programs in the Netherlands pay surprisingly little attention to the drinking patterns of this specific age group. The study described in this protocol will test the effectiveness of a web-based brief alcohol intervention that is aimed at reducing alcohol use among heavy drinking college students aged 18 to 24 years old. Methods/Design The effectiveness of the What Do You Drink web-based brief alcohol intervention will be tested among 908 heavy drinking college students in a two-arm parallel group randomized controlled trial. Participants will be allocated at random to either the experimental (N = 454: web-based brief alcohol intervention or control condition (N = 454: no intervention. The primary outcome measure will be the percentage of participants who drink within the normative limits of the Dutch National Health Council for low-risk drinking. These limits specify that, for heavy alcohol use, the mean consumption cannot exceed 14 or 21 glasses of standard alcohol units per week for females and males, respectively, while for binge drinking, the consumption cannot exceed five or more glasses of standard alcohol units on one drinking occasion at least once per week within one month and six months after the intervention. Reductions in mean weekly alcohol consumption and frequency of binge drinking are also primary outcome measures. Weekly Ecological Momentary Assessment will measure alcohol-related cognitions, that is, attitudes, self-efficacy, subjective norms and alcohol expectancies, which will be included as the secondary outcome measures. Discussion This study protocol describes the two-arm parallel group randomized controlled trial developed to evaluate the effectiveness of a web-based brief

  11. Modelling and simulation of the Positive and Negative Syndrome Scale (PANSS) time course and dropout hazard in placebo arms of schizophrenia clinical trials

    NARCIS (Netherlands)

    Pilla Reddy, Venkatesh; Kozielska, Magdalena; Johnson, Martin; Suleiman, Ahmed Abbas; Vermeulen, An; Liu, Jing; de Greef, Rik; Groothuis, Geny M M; Danhof, Meindert; Proost, Johannes H

    2012-01-01

    BACKGROUND AND OBJECTIVES: The likelihood of detecting a therapeutic signal of an effective drug for schizophrenia is impeded by a high placebo effect and by high dropout of patients. Several unsuccessful trials of schizophrenia, at least partly due to highly variable placebo effects, have indicated

  12. Influence of combined botanical extract preparation on body composition – results from double blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Łucja Pilaczyńska-Szcześniak

    2006-09-01

    Full Text Available Introduction: Obesity is becoming a great cause of concern in many countries. To shift the energy balance towards expenditure, dietary supplements should be designed to increase thermogenesis, lipolysis, loss of body water, and activation of digestive enzymes. Material and methods: Double blind randomized placebo-controlled clinical trial to evaluate a botanical water extract composed of green tea extract, bean peel and asparagus. During 56 days of the study body composition, anthropometric measurements and biochemical parameters were estimated in fifty-one healthy, moderately obese subjects. Results: Forty-two subjects completed the study according to the protocol. In the active preparation group, weight, BMI, percent of body fat, waist, hip and waist-to-hip ratio were not statistically different compared to placebo. The sum of skinfolds differed significantly. When selecting a subgroup of patients with hypercholesterolaemia (n=21, in the active extract group the change in body composition index (BCI and fat mass (FM were significant (p=0.037 and p=0.019 respectively in patients with hypercholesterolaemia when compared to normocholesterolaemic patients. Fat-free mass (FFM did not change significantly in the active extract group (p=0.083 when hypercholesterolaemic and normocholesterolaemic patients were compared. None of the parallel parameters (FM and FFM change, BCI changed significantly in the placebo group when compared to hypercholesterolaemic and normocholesterolaemic subjects. Conclusions: There was no statistically significant change in weight, BMI or percent of body fat measured by bioimpedance in the active extract and placebo groups. Obese patients with hypercholesterolaemia benefited from the active extract, with reduced total fat mass and a positive influence on the body composition improvement index.

  13. Lack of efficacy of a herbal preparation (RCM-102) for seasonal allergic rhinitis: a double blind, randomised, placebo-controlled trial

    OpenAIRE

    Lenon, George B; Li, C. G.; C. da Costa; Thien, F. C. K.; Shen, Y.; Xue, C. C. L.

    2012-01-01

    Background A herbal preparation, known as RMIT Chinese Medicine 102 (RCM-102) consisting of eight herbs which demonstrates inhibition of the release of key inflammatory mediators associated with seasonal allergic rhinitis (SAR) was used. This study evaluated the efficacy and safety of RCM-102 for SAR. Objective This study evaluated the efficacy and safety of RCM-102 for SAR. Methods This randomised placebo-controlled trial involved subjects aged between 18 and 65 who were randomly assigned to...

  14. Effects of natural childbirth preparation versus standard antenatal education on epidural rates, experience of childbirth and parental stress in mothers and fathers: a randomised controlled multicentre trial

    OpenAIRE

    Bergström, M; Kieler, H; Waldenström, U

    2009-01-01

    Objective To examine the effects of antenatal education focussing on natural childbirth preparation with psychoprophylactic training versus standard antenatal education on the use of epidural analgesia, experience of childbirth and parental stress in first-time mothers and fathers. Design Randomised controlled multicentre trial. Setting Fifteen antenatal clinics in Sweden between January 2006 and May 2007. Sample A total of 1087 nulliparous women and 1064 of their partners. Methods Natural gr...

  15. Vitrectomy with or without encircling band for pseudophakic retinal detachment: a multi-centre, three-arm, randomised clinical trial. VIPER Study Report No. 1—design and enrolment

    Science.gov (United States)

    Mazinani, B; Baumgarten, S; Schiller, P; Agostini, H; Helbig, H; Limburg, E; Hellmich, M; Walter, P

    2016-01-01

    Purpose Scleral buckling is currently used in addition to vitrectomy for the treatment of pseudophakic retinal detachment (PRD) to better support the vitreous base and better visualisation of the periphery. Aims The aims of this study are to evaluate (1) whether the combination of 20 G vitrectomy and scleral buckling is superior to 20 G vitrectomy alone (control) (confirmatory), and (2) whether transconjunctival 23/25 G vitrectomy is non-inferior to 20 G vitrectomy (both without scleral buckling) regarding operation success (exploratory). Methods The VIPER (Vitrectomy Plus Encircling Band Vs. Vitrectomy Alone For The Treatment Of Pseudophakic Retinal Detachment) study is an unmasked, multi-centre, three-arm randomised trial. Patients with PRD were eligible, excluding complicated retinal detachment or otherwise severe ophthalmologic impairment. Patients were randomised to one of three interventions: 20 G vitrectomy alone (control C), combination of 20 G vitrectomy and circumferential scleral buckling (experimental treatment E1) or 23/25 G vitrectomy alone (experimental treatment E2). The primary endpoint is the absence of any indication for a retina re-attaching procedure during 6 months of follow-up. Secondary endpoints include best corrected visual acuity, retina re-attaching procedures, complications and adverse events. Results From June 2011 to August 2013, 257 patients were enrolled in the study. The internet randomisation service assigned 100 patients each to the treatment arms C and E1, and 57 patients to treatment E2. The imbalance is due to the fact that several retinal surgeons did not qualify for performing E2. The random assignment was stratified and balanced (ie, 1:1 or 1:1:1 ratio) by surgeon. Conclusions The described study represents a methodologically rigorous protocol evaluating the benefits of three different vitrectomy approaches to PRD. The projected results will help to establish their overall efficacy and will permit

  16. Transplantation of autologous ex vivo expanded human conjunctival epithelial cells for treatment of pterygia: A prospective open-label single arm multicentric clinical trial

    Directory of Open Access Journals (Sweden)

    Viraf Sam Vasania

    2014-01-01

    Conclusion: We have, for the 1 st time, standardized a protocol for preparing autologous hCjEC grafts that can be safely transported to multiple centers across the country for transplantation. The clinical outcome was satisfactory for treating pterygia.

  17. Effects of neuromuscular electrical stimulation, laser therapy and LED therapy on the masticatory system and the impact on sleep variables in cerebral palsy patients: a randomized, five arms clinical trial

    Directory of Open Access Journals (Sweden)

    Giannasi Lilian

    2012-05-01

    Full Text Available Abstract Background Few studies demonstrate effectiveness of therapies for oral rehabilitation of patients with cerebral palsy (CP, given the difficulties in chewing, swallowing and speech, besides the intellectual, sensory and social limitations. Due to upper airway obstruction, they are also vulnerable to sleep disorders. This study aims to assess the sleep variables, through polysomnography, and masticatory dynamics, using electromiography, before and after neuromuscular electrical stimulation, associated or not with low power laser (Gallium Arsenide- Aluminun, =780 nm and LED (= 660 nm irradiation in CP patients. Methods/design 50 patients with CP, both gender, aged between 19 and 60 years will be enrolled in this study. The inclusion criteria are: voluntary participation, patient with hemiparesis, quadriparesis or diparetic CP, with ability to understand and respond to verbal commands. The exclusion criteria are: patients undergoing/underwent orthodontic, functional maxillary orthopedic or botulinum toxin treatment. Polysomnographic and surface electromyographic exams on masseter, temporalis and suprahyoid will be carry out in all sample. Questionnaire assessing oral characteristics will be applied. The sample will be divided into 5 treatment groups: Group 1: neuromuscular electrical stimulation; Group 2: laser therapy; Group 3: LED therapy; Group 4: neuromuscular electrical stimulation and laser therapy and Group 5: neuromuscular electrical stimulation and LED therapy. All patients will be treated during 8 consecutive weeks. After treatment, polysomnographic and electromiographic exams will be collected again. Discussion This paper describes a five arm clinical trial assessing the examination of sleep quality and masticatory function in patients with CP under non-invasive therapies. Trial registration The protocol for this study is registered with the Brazilian Registry of Clinical Trials - ReBEC RBR-994XFS Descriptors Cerebral Palsy

  18. A 3-Arm, Randomized, Controlled Trial of Heat-Sensitive Moxibustion Therapy to Determine Superior Effect among Patients with Lumbar Disc Herniation

    OpenAIRE

    Rixin Chen; Mingren Chen; Tongsheng Su; Meiqi Zhou; Jianhua Sun; Jun Xiong; Zhenhai Chi; Dingyi Xie; Bo Zhang

    2014-01-01

    Systematic reviews of moxibustion for LDH have identified ponderable evidence, especially for heat-sensitive moxibustion (HSM). Therefore, we designed and carried out the large sample trial to evaluate it. 456 patients were recruited from 4 centers in China and were randomly divided into three groups by the ratio of 1 : 1 : 1 to HSM (152) group, conventional moxibustion (152) group, and conventional drug plus acupuncture (152) group. Compared with usual care, there was a statistically signifi...

  19. Considerations for preparing a randomized population health intervention trial: lessons from a South African–Canadian partnership to improve the health of health workers

    Directory of Open Access Journals (Sweden)

    Annalee Yassi

    2014-05-01

    Full Text Available Background: Community-based cluster-randomized controlled trials (RCTs are increasingly being conducted to address pressing global health concerns. Preparations for clinical trials are well-described, as are the steps for multi-component health service trials. However, guidance is lacking for addressing the ethical and logistic challenges in (cluster RCTs of population health interventions in low- and middle-income countries. Objective: We aimed to identify the factors that population health researchers must explicitly consider when planning RCTs within North–South partnerships. Design: We reviewed our experiences and identified key ethical and logistic issues encountered during the pre-trial phase of a recently implemented RCT. This trial aimed to improve tuberculosis (TB and Human Immunodeficiency Virus (HIV prevention and care for health workers by enhancing workplace assessment capability, addressing concerns about confidentiality and stigma, and providing onsite counseling, testing, and treatment. An iterative framework was used to synthesize this analysis with lessons taken from other studies. Results: The checklist of critical factors was grouped into eight categories: 1 Building trust and shared ownership; 2 Conducting feasibility studies throughout the process; 3 Building capacity; 4 Creating an appropriate information system; 5 Conducting pilot studies; 6 Securing stakeholder support, with a view to scale-up; 7 Continuously refining methodological rigor; and 8 Explicitly addressing all ethical issues both at the start and continuously as they arise. Conclusion: Researchers should allow for the significant investment of time and resources required for successful implementation of population health RCTs within North–South collaborations, recognize the iterative nature of the process, and be prepared to revise protocols as challenges emerge.

  20. A STUDY ON THE EVALUATION OF EFFICACY AND SAFETY OF A MULTIHERBAL PREPARATION (ANDROMET IN ERECTILE DYSFUNCTION (ED: A RANDOMISED PLACEBO CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    Adhikari Anjan

    2011-05-01

    Full Text Available Erectile Dysfunction (ED is a common problem with various aetiology. Recent advance discovered many drugs with specific mechanism of action. But till now there is no drug or medicine which is therapeutically successful. In Ayurveda, there was many formulations which can be tried on patients of ED. Present study is a double blind controlled randomised trial of efficacy and safety of a multiherbal preparation on ED. 35 patient of ED completed treatment with the multiherbal preparation (Andromet TM compared with 15 patient of ED completed treatment with identical looking placebo as control. Results showed significant improvement in ED amongst the patients treated with multiherbal preparation (Andromet in comparison with placebo treated group.

  1. Protocol for an open-label, single-arm trial of HIV pre-exposure prophylaxis (PrEP) among people at high risk of HIV infection: the NSW Demonstration Project PRELUDE

    Science.gov (United States)

    Vaccher, S; Grulich, A; McAllister, J; Templeton, D J; Bloch, M; McNulty, A; Holden, J; Poynten, I M; Prestage, G; Zablotska, I

    2016-01-01

    Introduction Despite a number of HIV prevention strategies, the number of new HIV infections remains high. In Australia, over three-quarters of new HIV diagnoses are in gay and bisexual men (GBM). Pre-exposure prophylaxis (PrEP) has been shown to be effective at preventing new HIV infections in several randomised trials. The PRELUDE study aims to evaluate the implementation of PrEP in healthcare settings in New South Wales (NSW), Australia, among a sample of high-risk adults. Methods and analysis PRELUDE is an ongoing open-label, single-arm demonstration project, conducted in public and private clinics across NSW, Australia. Enrolment began in November 2014. The study is designed for 300 high-risk participants—mainly GBM and heterosexual women. Participants receive daily oral PrEP, composed of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), for up to 2.5 years. Quarterly study visits include testing for HIV and sexually transmitted infections (STIs), assessment of ongoing eligibility and side effects, and self-reported adherence. Following each study visit, online behavioural surveys are administered to collect information on medication adherence, risk behaviours and attitudes. Blood samples will be collected in a subset of patients 1, 6 and 12 months after PrEP initiation to measure FTC/TDF concentrations. Analyses using longitudinal regression models will focus on feasibility, adherence, safety, tolerability and effects of PrEP on behaviour. This study will inform PrEP policy and guide the implementation of PrEP in Australia in people at high risk of HIV. Ethics and dissemination The study will be conducted in accordance with the Declaration of Helsinki. All patients will provide written informed consent prior to participation in the study. Publications relating to each of the primary end points will be gradually released after 12 months of follow-up is complete. Trial registration number NCT02206555; Pre-results. PMID:27324719

  2. Methods of preparation of fatty acid methyl esters (FAME. Statistical assessment of the precision characteristics from a collaborative trial

    Directory of Open Access Journals (Sweden)

    Pérez-Camino, M. C.

    2000-12-01

    Full Text Available The official regulations for the control of the olive and olive pomace oils of the European Union (EU and International Olive Oil Council (IOOC include the determination of fatty acids in order to be applied to several purity criteria. The determination of fatty acids require the preparation of the fatty acid methyl esters (FAME for the subsequent analysis by gas chromatography with good precision and reproducibility. Among the methods used in the laboratories of both the industries and the official institutions looking after the olive oil control, the ones selected were: 1 cold methylation with methanolic potash and 2 hot methylation with sodium methylate followed by acidification with sulphuric acid in methanol and heating. A statistical assessment of the precision characteristics were performed on the determination of fatty acids using both methods by a collaborative trial following the directions included in the AOAC regulation (AOAC 1995. In oils with low acidities, the results obtained for both methylation methods were equivalent. However, the olivepomace oil sample (acidity 15.5% showed significative differences between the fatty acid compositions obtained using both methylation methods. Finally, the methylation with the acidic+basic method did not yield an increase of the trans-isomers of the fatty acids.Los métodos oficiales para el control del aceite de oliva y de orujo de oliva de la Unión Europea (UE y del Comité Oleícola Internacional (COI incluyen la determinación de ácidos grasos en la aplicación de varios criterios de pureza. La determinación de ácidos grasos requiere la preparación de los ésteres metílicos de los ácidos grasos (FAME y su posterior análisis mediante cromatografía de gases con una buena repetibilidad y reproducibilidad. Entre los muchos métodos usados por los laboratorios de la industria y de los organismos oficiales de control, se seleccionaron los siguientes: 1 metilación en frío con potasa

  3. Evaluation of a Dutch school-based depression prevention program for youths in highrisk neighborhoods: study protocol of a two-armed randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kindt Karlijn CM

    2012-03-01

    families and will reduce costs in health care. In addition, the results of the study advances current knowledge on the underlying mechanisms of the development of depression and may aid the improvement of depression prevention programs in general. Trial registration Dutch Trial Register NTR3110

  4. Exercise as an Intervention to Reduce Study-Related Fatigue among University Students: A Two-Arm Parallel Randomized Controlled Trial

    Science.gov (United States)

    de Vries, Juriena D.; van Hooff, Madelon L. M.; Geurts, Sabine A. E.; Kompier, Michiel A. J.

    2016-01-01

    that were found in this study imply that the intervention has the potential to promote regular exercise and accompanying beneficial effects in the longer run. Trial Registration Netherlands Trial Register NTR4412 PMID:27031610

  5. A 3-Arm, Randomized, Controlled Trial of Heat-Sensitive Moxibustion Therapy to Determine Superior Effect among Patients with Lumbar Disc Herniation

    Directory of Open Access Journals (Sweden)

    Rixin Chen

    2014-01-01

    Full Text Available Systematic reviews of moxibustion for LDH have identified ponderable evidence, especially for heat-sensitive moxibustion (HSM. Therefore, we designed and carried out the large sample trial to evaluate it. 456 patients were recruited from 4 centers in China and were randomly divided into three groups by the ratio of 1 : 1 : 1 to HSM (152 group, conventional moxibustion (152 group, and conventional drug plus acupuncture (152 group. Compared with usual care, there was a statistically significant reduction in mean M-JOA score at 2 weeks and 6 months for HSM (3.8 ± 2.6 versus 8.5 ± 2.9; 3.7 ± 2.2 versus 10.1 ± 2.9 and conventional moxibustion (7.9 ± 3.0 versus 8.5 ± 2.9; 8.9 ± 3.1 versus 10.1 ± 2.9. Compared with conventional moxibustion group, HSM group showed greater improvement in all the outcomes. The mean dose of moxibustion was 41.13 ± 5.26 (range 21–60 minutes in the HSM group. We found that HSM was more effective in treating patients with LDH, compared with conventional moxibustion and conventional drug plus acupuncture. This finding indicated that the application of moxibustion on the heat-sensitive points is a good moxibustion technique in treating disease.

  6. Exercise as an Intervention to Reduce Study-Related Fatigue among University Students: A Two-Arm Parallel Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Juriena D de Vries

    that the intervention has the potential to promote regular exercise and accompanying beneficial effects in the longer run.Netherlands Trial Register NTR4412.

  7. Triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for H pylori eradication: A comparative three-armed randomized clinical trial

    Institute of Scientific and Technical Information of China (English)

    Seyed Amir Mirbagheri; Mehrdad Hasibi; Mehdi Abouzari; Armin Rashidi

    2006-01-01

    AIM: To compare the effectiveness of triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for H pylori eradication in a comparative threearmed randomized clinical trial. METHODS: A total of 360 H pylori-positive patients suffering from dyspepsia and aging 24-79 years with a median age of 42 years were enrolled in the study and randomly allocated into the following three groups: group A (n = 120) received a standard 1-wk triple therapy (20mg omeprazole b.I.d., 1000 mg amoxicillin b.I.d., 500 mg clarithromycin b.I.d.); group B (n = 120) received a 10-d standard quadruple therapy (20 mg omeprazole b.I.d., 1000 mg amoxicillin b.I.d., 240 mg colloidal bismuth subcitrate b.I.d., and 500 mg metronidazole b.I.d.); group C (n = 120) received the new protocol, I.e. 375 mg sultamicillin (225 mg ampicillin plus 150 mg sulbactam) b.I.d. (before breakfast and dinner), instead of amoxicillin in the standard quadruple therapy for the same duration. Chi-square test with the consideration of P < 0.05 as significant was used to compare the eradication rates by intention-to-treat and per-protocol analyses in the three groups. RESULTS: The per-protocol eradication rate was 91.81% (101 patients from a total of 110) in group A, 85.84% (97patients from a total of 113) in group B, and 92.85% (104 patients from a total of 112) in group C. The intentionto-treat eradication rate was 84.17% in group A, 80.83% in group B, and 86.67% in group C. The new protocol yielded the highest eradication rates by both per-protocol and intention-to-treat analyses followed by the standard triple and quadruple regimens, respectively. However, the differences were not statistically significant between the three groups. CONCLUSION: The results of this study provide further support for the equivalence of triple and quadruple therapies in terms of effectiveness, compliance and sideeffect profile when administered as first-line treatmentfor Hpylori infection. Moreover, the new protocol

  8. Evaluation of a birth preparation program on lumbopelvic pain, urinary incontinence, anxiety and exercise: a randomized controlled trial

    OpenAIRE

    Miquelutti, Maria Amélia; Cecatti, José Guilherme; Makuch, Maria Yolanda

    2013-01-01

    Background Antenatal preparation programmes are recommended worldwide to promote a healthy pregnancy and greater autonomy during labor and delivery, prevent physical discomfort and high levels of anxiety. The objective of this study was to evaluate effectiveness and safety of a birth preparation programme to minimize lumbopelvic pain, urinary incontinence, anxiety, and increase physical activity during pregnancy as well as to compare its effects on perinatal outcomes comparing two groups of n...

  9. Biocompatibility and in vitro antineoplastic drug-loaded trial of titania nanotubes prepared by anodic oxidation of a pure titanium

    Institute of Scientific and Technical Information of China (English)

    2009-01-01

    TiO2 nanotube (NT) arrays have been prepared by anodic oxidation of a Ti sheet,and carbon-deposited TiO2 NT arrays have been prepared by annealing TiO2 NT arrays in carbon atmosphere. The biocompatibility of the as-prepared NT arrays was investigated by observing the growth of osteosarcoma (MG-63) cells on the NT arrays. The application of the TiO2 NT arrays as a drug delivery vehicle was investigated. Both the TiO2 NTs and the carbon-modified TiO2 NTs have good biocompatibility supporting the normal growth and adhesion of MG-63 cells with no need of extracellular matrix protein coating. The one end-opened TiO2 NTs can be easily filled with drugs,working as an efficient drug delivery vehicle.

  10. Preliminary Toxicity Analysis of 3-Dimensional Conformal Radiation Therapy Versus Intensity Modulated Radiation Therapy on the High-Dose Arm of the Radiation Therapy Oncology Group 0126 Prostate Cancer Trial

    Energy Technology Data Exchange (ETDEWEB)

    Michalski, Jeff M., E-mail: jmichalski@radonc.wustl.edu [Department of Radiation Oncology Washington University Medical Center, St. Louis, Missouri (United States); Yan, Yan [Radiation Therapy Oncology Group Statistical Center, Philadelphia, Pennsylvania (United States); Watkins-Bruner, Deborah [Emory University School of Nursing, Atlanta, Georgia (United States); Bosch, Walter R. [Department of Radiation Oncology Washington University Medical Center, St. Louis, Missouri (United States); Winter, Kathryn [Radiation Therapy Oncology Group Statistical Center, Philadelphia, Pennsylvania (United States); Galvin, James M. [Department of Radiation Oncology Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States); Bahary, Jean-Paul [Department of Radiation Oncology Centre Hospitalier de l' Université de Montréal-Notre Dame, Montreal, QC (Canada); Morton, Gerard C. [Department of Radiation Oncology Toronto-Sunnybrook Regional Cancer Centre, Toronto, ON (Canada); Parliament, Matthew B. [Department of Oncology Cross Cancer Institute, Edmonton, AB (Canada); Sandler, Howard M. [Department of Radiation Oncology Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California (United States)

    2013-12-01

    Purpose: To give a preliminary report of clinical and treatment factors associated with toxicity in men receiving high-dose radiation therapy (RT) on a phase 3 dose-escalation trial. Methods and Materials: The trial was initiated with 3-dimensional conformal RT (3D-CRT) and amended after 1 year to allow intensity modulated RT (IMRT). Patients treated with 3D-CRT received 55.8 Gy to a planning target volume that included the prostate and seminal vesicles, then 23.4 Gy to prostate only. The IMRT patients were treated to the prostate and proximal seminal vesicles to 79.2 Gy. Common Toxicity Criteria, version 2.0, and Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late morbidity scores were used for acute and late effects. Results: Of 763 patients randomized to the 79.2-Gy arm of Radiation Therapy Oncology Group 0126 protocol, 748 were eligible and evaluable: 491 and 257 were treated with 3D-CRT and IMRT, respectively. For both bladder and rectum, the volumes receiving 65, 70, and 75 Gy were significantly lower with IMRT (all P<.0001). For grade (G) 2+ acute gastrointestinal/genitourinary (GI/GU) toxicity, both univariate and multivariate analyses showed a statistically significant decrease in G2+ acute collective GI/GU toxicity for IMRT. There were no significant differences with 3D-CRT or IMRT for acute or late G2+ or 3+ GU toxicities. Univariate analysis showed a statistically significant decrease in late G2+ GI toxicity for IMRT (P=.039). On multivariate analysis, IMRT showed a 26% reduction in G2+ late GI toxicity (P=.099). Acute G2+ toxicity was associated with late G3+ toxicity (P=.005). With dose–volume histogram data in the multivariate analysis, RT modality was not significant, whereas white race (P=.001) and rectal V70 ≥15% were associated with G2+ rectal toxicity (P=.034). Conclusions: Intensity modulated RT is associated with a significant reduction in acute G2+ GI/GU toxicity. There is a trend for a

  11. HIV-1 drug resistance emergence among breastfeeding infants born to HIV-infected mothers during a single-arm trial of triple-antiretroviral prophylaxis for prevention of mother-to-child transmission: a secondary analysis.

    Directory of Open Access Journals (Sweden)

    Clement Zeh

    2011-03-01

    Full Text Available BACKGROUND: Nevirapine and lamivudine given to mothers are transmitted to infants via breastfeeding in quantities sufficient to have biologic effects on the virus; this may lead to an increased risk of a breastfed infant's development of resistance to maternal antiretrovirals. The Kisumu Breastfeeding Study (KiBS, a single-arm open-label prevention of mother-to-child HIV transmission (PMTCT trial, assessed the safety and efficacy of zidovudine, lamivudine, and either nevirapine or nelfinavir given to HIV-infected women from 34 wk gestation through 6 mo of breastfeeding. Here, we present findings from a KiBS trial secondary analysis that evaluated the emergence of maternal ARV-associated resistance among 32 HIV-infected breastfed infants. METHODS AND FINDINGS: All infants in the cohort were tested for HIV infection using DNA PCR at multiple study visits during the 24 mo of the study, and plasma RNA viral load for all HIV-PCR-positive infants was evaluated retrospectively. Specimens from mothers and infants with viral load >1,000 copies/ml were tested for HIV drug resistance mutations. Overall, 32 infants were HIV infected by 24 mo of age, and of this group, 24 (75% infants were HIV infected by 6 mo of age. Of the 24 infants infected by 6 mo, nine were born to mothers on a nelfinavir-based regimen, whereas the remaining 15 were born to mothers on a nevirapine-based regimen. All infants were also given single-dose nevirapine within 48 hours of birth. We detected genotypic resistance mutations in none of eight infants who were HIV-PCR positive by 2 wk of age (specimens from six infants were not amplifiable, for 30% (6/20 at 6 wk, 63% (14/22 positive at 14 wk, and 67% (16/24 at 6 mo post partum. Among the 16 infants with resistance mutations by 6 mo post partum, the common mutations were M184V and K103N, conferring resistance to lamivudine and nevirapine, respectively. Genotypic resistance was detected among 9/9 (100% and 7/15 (47% infected infants

  12. Enzyme-catalyzed preparation of supramolecular structured hydrogel of polypseudorotaxanes derived from the self-assembly of α-CDs with 3-arm p-hydroxyphenylpropionate terminated PEG

    Institute of Scientific and Technical Information of China (English)

    XIE Zhiguo; HOU Dandan; YE Lin; ZHANG Aiying; FENG Zengguo

    2007-01-01

    A kind of novel 3-D cross-1inked supramolecular structured hydrogels has been fabricated via enzymatic oxidative coupling of polypseudorotaxanes (PPRs) derived from the self-assembly of α-cyclodextrins (α-CDs) with 3-arm p-hydroxyphenylpropionate terminated PEG (3-HPPP) as a macromer by using horseradish peroxidase (HRP)/H2O2 catalytic system.The enzymatic cross-1inking of the macromer or PPRs made with a smaller amount of α-CDs was found to be much faster than that by ordinary chemical pathways,showing the promise to be used as the surgical adhesive and sealant which are needed to rapidly function in vivo.The gelation time was highly extended and the gel content was considerably decreased by increasing the α-CDs to macromer feeding molar ratio.Thereby these hydrogels exhibited a decreasing trend in dynamical mechanical properties with increasing the amount of α-CDs in regard to the blank hydrogel made without α-CD addition.

  13. Rationale and design of ATHENA: A placebo-controlled, double-blind, parallel arm trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular hospitalization or death from any cause in PatiENts with atrial fibrillation/atrial flutter

    DEFF Research Database (Denmark)

    Hohnloser, S.H.; Connolly, S.J.; Crijns, H.J.G.M.;

    2008-01-01

    Rationale and Design of ATHENA. Background: Atrial fibrillation (AF) is the most commonly encountered clinical arrhythmia, predominantly affecting elderly patients. There is a continued need for new antiarrhythmic drugs to treat the ever-increasing number of patients with this arrhythmia......ENts with Atrial fibrillation/atrial flutter) is the largest single antiarrhythmic drug trial ever conducted. More than 4,600 patients with a history of AF or atrial flutter (AFL) have been randomized to receive dronedarone 400 mg bid or matching placebo. The primary study endpoint is time to first....... Dronedarone is a new antiarrhythmic compound currently being developed for treatment of AF. Methods: The ATHENA trial (A placebo-controlled, double-blind, parallel arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in pati...

  14. Bowel Preparation for Colonoscopy with Sodium Phosphate Solution versus Polyethylene Glycol-Based Lavage: A Multicenter Trial

    Directory of Open Access Journals (Sweden)

    S. Schanz

    2008-01-01

    Full Text Available Background: Adequate bowel preparation is essential for accurate colonoscopy. Both oral sodium phosphate (NaP and polyethylene glycol-based lavage (PEG-ELS are used predominantly as bowel cleansing modalities. NaP has gained popularity due to low drinking volume and lower costs. The purpose of this randomized multicenter observer blinded study was to compare three groups of cleansing (NaP, NaP + sennosides, PEG-ELS + sennosides in reference to tolerability, acceptance, and cleanliness. Patient and Methods: 355 outpatients between 18 and 75 years were randomized into three groups (A, B, C receiving NaP = A, NaP, and sennosides = B or PEG-ELS and sennosides = C. Gastroenterologists performing colonoscopies were blinded to the type of preparation. All patients documented tolerance and adverse events. Vital signs, premedication, completeness, discomfort, and complications were recorded. A quality score (0–4 of cleanliness was generated. Results: The three groups were similar with regard to age, sex, BMI, indication for colonoscopy, and comorbidity. Drinking volumes (L (A = 4.33 + 1.2, B = 4.56 + 1.18, C = 4.93 + 1.71 were in favor of NaP (P = .005. Discomfort from ingested fluid was recorded in A = 39.8% (versus C: P = .015, B = 46.6% (versus C: P = .147, and C = 54.6%. Differences in tolerability and acceptance between the three groups were statistically not significant. No differences in adverse events and the cleanliness effects occurred in the three groups (P = .113. The cleanliness quality scores 0–2 were calculated in A: 77.7%, B: 86.7%, and C: 85.2%. Conclusions: These data fail to demonstrate significant differences in tolerability, acceptance, and preparation quality between the three types of bowel preparation for colonoscopy. Cleansing with NaP was not superior to PEG-ELS.

  15. An improved instrument mounting arm.

    Science.gov (United States)

    Gendeh, B S; Khalid, B A; Alberti, P W

    2001-02-01

    Although some form of commercial instrument mounting arm is available, a paucity of information in the literature may cause problems in selecting the most appropriate model for an ENT department wishing to trial their invention for use in the clinic or operating theatre. The instrument mounting arm described here is based on existing designs used by hobbyists and model makers for many years but the main benefit of this innovation is its multi-purpose use in the operating theatre and cost effectiveness since it is made of aluminum alloy. It is compact, stable and easily adjustable and can incorporate an endoscope holder or an operating end piece to mount various ENT instruments that offers considerable advantages to the unassisted operator. PMID:11320829

  16. Analysis of stroke in ATHENA: a placebo-controlled, double-blind, parallel-arm trial to assess the efficacy of dronedarone 400 mg BID for the prevention of cardiovascular hospitalization or death from any cause in patients with atrial fibrillation/atrial flutter

    DEFF Research Database (Denmark)

    Connolly, Stuart J; Crijns, Harry J G M; Torp-Pedersen, Christian;

    2009-01-01

    stroke has been evaluated in a randomized, double-blind clinical trial, ATHENA (A placebo-controlled, double-blind, parallel-arm Trial to assess the efficacy of dronedarone 400 mg BID for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation......BACKGROUND: Many patients with atrial fibrillation are at high risk for stroke and require antithrombotic therapy. Antiarrhythmic drugs have not previously been shown to reduce the risk of stroke in atrial fibrillation. The effect of dronedarone, a new multichannel-blocking antiarrhythmic drug, on....../atrial flutter). METHODS AND RESULTS: Patients with persistent or paroxysmal atrial fibrillation and at least 1 risk factor for cardiovascular hospitalization were randomized to receive dronedarone (400 mg BID) or double-blind matching placebo and followed up for a minimum of 1 year to a common termination at 30...

  17. Most Correlated Arms Identification

    OpenAIRE

    Liu, Che-Yu; Bubeck, Sébastien

    2014-01-01

    We study the problem of finding the most mutually correlated arms among many arms. We show that adaptive arms sampling strategies can have significant advantages over the non-adaptive uniform sampling strategy. Our proposed algorithms rely on a novel correlation estimator. The use of this accurate estimator allows us to get improved results for a wide range of problem instances.

  18. Efficacy of a children’s procedural preparation and distraction device on healing in acute burn wound care procedures: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Brown Nadia J

    2012-12-01

    Full Text Available Abstract Background The intense pain and anxiety triggered by burns and their associated wound care procedures are well established in the literature. Non-pharmacological intervention is a critical component of total pain management protocols and is used as an adjunct to pharmacological analgesia. An example is virtual reality, which has been used effectively to dampen pain intensity and unpleasantness. Possible links or causal relationships between pain/anxiety/stress and burn wound healing have previously not been investigated. The purpose of this study is to investigate these relationships, specifically by determining if a newly developed multi-modal procedural preparation and distraction device (Ditto™ used during acute burn wound care procedures will reduce the pain and anxiety of a child and increase the rate of re-epithelialization. Methods/design Children (4 to 12 years with acute burn injuries presenting for their first dressing change will be randomly assigned to either the (1 Control group (standard distraction or (2 Ditto™ intervention group (receiving Ditto™, procedural preparation and Ditto™ distraction. It is intended that a minimum of 29 participants will be recruited for each treatment group. Repeated measures of pain intensity, anxiety, stress and healing will be taken at every dressing change until complete wound re-epithelialization. Further data collection will aid in determining patient satisfaction and cost effectiveness of the Ditto™ intervention, as well as its effect on speed of wound re-epithelialization. Discussion Results of this study will provide data on whether the disease process can be altered by reducing stress, pain and anxiety in the context of acute burn wounds. Trial registration ACTRN12611000913976

  19. The arms race control

    International Nuclear Information System (INIS)

    Written in 1961, this paper presents the content of a book entitled 'The arms race control' where the author outlined the difference between disarmament and arms control, described the economic and moral role of arms race, the importance of force balance for international security. He wandered whether arms control could ensure this balance and whether nuclear balance meant force balance. Force balance then appears to be a precarious and unsteady component of international security. He commented the challenges of disarmament, recalled some arguments for a nuclear disarmament. Then he discussed what would be an arms control with or without disarmament (either nuclear or conventional)

  20. Safety of Placebo Controls in Pediatric Hypertension Trials

    OpenAIRE

    Smith, P. Brian; Li, Jennifer S.; Murphy, M. Dianne; Califf, Robert M.; Daniel K. Benjamin

    2008-01-01

    Many clinical trials, including those in pediatric populations, use a placebo arm for medical conditions for which there are readily available therapeutic interventions. Several short-term efficacy trials of antihypertensive medications performed in response to Food and Drug Administration-issued written requests have used a placebo arm; whether the use of a placebo arm is safe in children with hypertension is unknown. We sought to define the rates of adverse events in 10 short-term antihyper...

  1. Detecting Illegal Arms Trade

    OpenAIRE

    DellaVigna, Stefano; Ferrara, Eliana La

    2010-01-01

    Illegal arms are responsible for thousands of deaths in civil wars every year. Yet, their trade is very hard to detect. We propose a method to statistically detect illegal arms trade based on the investor knowledge embedded in financial markets. We focus on eight countries under UN arms embargo in the period 1990-2005, and analyze eighteen events during the embargo that suddenly increase or decrease conflict intensity. If the weapon-making companies are not trading or are trading legally, an ...

  2. ARM Mentor Selection Process

    Energy Technology Data Exchange (ETDEWEB)

    Sisterson, D. L. [Argonne National Lab. (ANL), Argonne, IL (United States)

    2015-10-01

    The Atmospheric Radiation Measurement (ARM) Program was created in 1989 with funding from the U.S. Department of Energy (DOE) to develop several highly instrumented ground stations to study cloud formation processes and their influence on radiative transfer. In 2003, the ARM Program became a national scientific user facility, known as the ARM Climate Research Facility. This scientific infrastructure provides for fixed sites, mobile facilities, an aerial facility, and a data archive available for use by scientists worldwide through the ARM Climate Research Facility—a scientific user facility. The ARM Climate Research Facility currently operates more than 300 instrument systems that provide ground-based observations of the atmospheric column. To keep ARM at the forefront of climate observations, the ARM infrastructure depends heavily on instrument scientists and engineers, also known as lead mentors. Lead mentors must have an excellent understanding of in situ and remote-sensing instrumentation theory and operation and have comprehensive knowledge of critical scale-dependent atmospheric processes. They must also possess the technical and analytical skills to develop new data retrievals that provide innovative approaches for creating research-quality data sets. The ARM Climate Research Facility is seeking the best overall qualified candidate who can fulfill lead mentor requirements in a timely manner.

  3. Managing new arms races

    International Nuclear Information System (INIS)

    The management of new arms races in the region of Asia-Pacific includes considerations of weapons trade and transfer in the region, with an emphasis on nuclear weapons proliferation. It deals with the problem of controlling the arms trade and the efforts to control conventional weapons and underlines the possible role and influence of Conference on Cooperation and Security in Europe (CSCE)

  4. Effects of PREPARE, a Multi-component, School-Based HIV and Intimate Partner Violence (IPV) Prevention Programme on Adolescent Sexual Risk Behaviour and IPV: Cluster Randomised Controlled Trial.

    Science.gov (United States)

    Mathews, Catherine; Eggers, Sander M; Townsend, Loraine; Aarø, Leif E; de Vries, Petrus J; Mason-Jones, Amanda J; De Koker, Petra; McClinton Appollis, Tracy; Mtshizana, Yolisa; Koech, Joy; Wubs, Annegreet; De Vries, Hein

    2016-09-01

    Young South Africans, especially women, are at high risk of HIV. We evaluated the effects of PREPARE, a multi-component, school-based HIV prevention intervention to delay sexual debut, increase condom use and decrease intimate partner violence (IPV) among young adolescents. We conducted a cluster RCT among Grade eights in 42 high schools. The intervention comprised education sessions, a school health service and a school sexual violence prevention programme. Participants completed questionnaires at baseline, 6 and 12 months. Regression was undertaken to provide ORs or coefficients adjusted for clustering. Of 6244 sampled adolescents, 55.3 % participated. At 12 months there were no differences between intervention and control arms in sexual risk behaviours. Participants in the intervention arm were less likely to report IPV victimisation (35.1 vs. 40.9 %; OR 0.77, 95 % CI 0.61-0.99; t(40) = 2.14) suggesting the intervention shaped intimate partnerships into safer ones, potentially lowering the risk for HIV. PMID:27142057

  5. Preparation and characterization of six-arm star-shaped poly(ε-caprolactone) with inositol%肌醇为核的星形聚己内酯的制备及表征

    Institute of Scientific and Technical Information of China (English)

    王翠伟; 刘超; 阳紫莹; 朱小卫; 孙洪范; 孔德领; 杨菁; 宋存先

    2014-01-01

    Objective To prepare a series of six-arm star-shaped poly(ε-caprolactone)(6-s-PCL) with different molecular weight and evaluate their biocompatibility.Methods The polymers were synthesized by stannous octoate catalyzed ring-opening polymerization of ε-caprolactone with inositol as multifunctional initiator.The structure of the polymers was characterized with Fourier transform infrared spectrometer(FT-IR) and nuclear magnetic resonance spectroscope(1H-NMR),the molecular weight and polydispersity index were tested by gel exclusion chromatography (GPC).The thermal behavior of polymers was analyzed by differential scanning calorimetry (DSC).Subsequently,the nanoparticles of 6-s-PCL were prepared by ultrasound/solvent evaporation method,and dynamic light scattering (DLS) was adopted to investigate the size and potential of nanoparticles.The cytotoxicity of 6-s-PCL was detected by water soluble tetrazolium salt reagent(WST-1) assay.Results The nanoparticles prepared from 6-s-PCL exhibited irregular spherical shape as shown by FT-IR and 1H-NMR,and the molecular weight determined by GPC was 22 822,31 459,and 49 533,respectively,and distributed unimodally.The result of DSC showed that the melting temperature(Tm),melting enthalpy(△H) and crystallinity(Xc) were increased with increasing molecular weight.The nanoparticles were in uniform oval shape,with mean diameter of 100-200 nm.In addition,the polymers showed excellent biocompatibility as demonstrated by WST-1 assay.Conclusion The 6-s-PCL is prepared successfully,which demonstrates good biocompatibility and might be an appropriate candidate as drug carriers.%目的 制备六臂星形聚己内酯并评价其生物相容性.方法 采用本体开环聚合法以ε-己内酯为单体,辛酸亚锡为催化剂,肌醇为多功能基团引发剂,合成一系列不同相对分子质量的六臂星形聚己内酯(6-s-PCk)(其中x为单体与引发剂的摩尔比).通过傅里叶红外光谱(FT-IR)、核磁共振氢谱(1H-NMR)、

  6. Nonspecific Arm Pain

    Directory of Open Access Journals (Sweden)

    Ali Moradi

    2013-12-01

    Full Text Available Nonspecific activity-related arm pain is characterized by an absence of objective physical findings and symptoms that do not correspond with objective pathophysiology. Arm pain without strict diagnosis is often related to activity, work-related activity in particular, and is often seen in patients with physically demanding work. Psychological factors such as catastrophic thinking, symptoms of depression, and heightened illness concern determine a substantial percentage of the disability associated with puzzling hand and arm pains. Ergonomic modifications can help to control symptoms, but optimal health may require collaborative management incorporating psychosocial and psychological elements of illness.

  7. Nonspecific Arm Pain

    Directory of Open Access Journals (Sweden)

    Ali Moradi

    2013-12-01

    Full Text Available   Nonspecific activity-related arm pain is characterized by an absence of objective physical findings and symptoms that do not correspond with objective pathophysiology. Arm pain without strict diagnosis is often related to activity, work-related activity in particular, and is often seen in patients with physically demanding work. Psychological factors such as catastrophic thinking, symptoms of depression, and heightened illness concern determine a substantial percentage of the disability associated with puzzling hand and arm pains. Ergonomic modifications can help to control symptoms, but optimal health may require collaborative management incorporating psychosocial and psychological elements of illness.

  8. An Elastica Arm Scale

    CERN Document Server

    Bosi, F; Corso, F Dal; Bigoni, D

    2015-01-01

    The concept of 'deformable arm scale' (completely different from a traditional rigid arm balance) is theoretically introduced and experimentally validated. The idea is not intuitive, but is the result of nonlinear equilibrium kinematics of rods inducing configurational forces, so that deflection of the arms becomes necessary for the equilibrium, which would be impossible for a rigid system. In particular, the rigid arms of usual scales are replaced by a flexible elastic lamina, free of sliding in a frictionless and inclined sliding sleeve, which can reach a unique equilibrium configuration when two vertical dead loads are applied. Prototypes realized to demonstrate the feasibility of the system show a high accuracy in the measure of load within a certain range of use. It is finally shown that the presented results are strongly related to snaking of confined beams, with implications on locomotion of serpents, plumbing, and smart oil drilling.

  9. ARM7-kehityskortti

    OpenAIRE

    Kukkonen, Henri

    2006-01-01

    Tämän opinnäytetyön tarkoituksena oli suunnitella ja toteuttaa ARM-mikro-ohjain pohjainen kehityskortti. Kortin tuli olla soveltuva ARM-ohjelmoinnin opettamiseen. Työssä myös selvitettiin ARM-mikro-ohjaimen ohjelmointiympäristön käyttöönotto. Teoriaosassa käsitellään ARM-arkkitehtuuria, työssä käytettyjen Atmelin AT91R40008-mikro-ohjaimen sekä Philipsin LPC2105-mikro-ohjaimen ominaisuuksia. Erityisesti työssä keskitytään kehityskorttien suunnitteluun. Kehityskortin vaatimuksina oli, että se ...

  10. ARM for Platform Application

    Science.gov (United States)

    Patte, Mathieu; Poupat, Jean-Luc; Le Meur, Patrick

    2015-09-01

    The activities described in this paper are part of the CNES R&T “Study of a Cortex-R ARM based architecture” performed by Airbus DS Space System & Electronics in 2014. With the support of CNES, Airbus DS has performed the porting of a representative space application software on an ARM based demonstration platform. This paper presents the platform itself, the activities performed at software level and the first results on this evaluation study.

  11. Hello to Arms

    Science.gov (United States)

    2005-01-01

    This image highlights the hidden spiral arms (blue) that were discovered around the nearby galaxy NGC 4625 by the ultraviolet eyes of NASA's Galaxy Evolution Explorer. The image is composed of ultraviolet and visible-light data, from the Galaxy Evolution Explorer and the California Institute of Technology's Digitized Sky Survey, respectively. Near-ultraviolet light is colored green; far-ultraviolet light is colored blue; and optical light is colored red. As the image demonstrates, the lengthy spiral arms are nearly invisible when viewed in optical light while bright in ultraviolet. This is because they are bustling with hot, newborn stars that radiate primarily ultraviolet light. The youthful arms are also very long, stretching out to a distance four times the size of the galaxy's core. They are part of the largest ultraviolet galactic disk discovered so far. Located 31 million light-years away in the constellation Canes Venatici, NGC 4625 is the closest galaxy ever seen with such a young halo of arms. It is slightly smaller than our Milky Way, both in size and mass. However, the fact that this galaxy's disk is forming stars very actively suggests that it might evolve into a more massive and mature galaxy resembling our own. The armless companion galaxy seen below NGC 4625 is called NGC 4618. Astronomers do not know why it lacks arms but speculate that it may have triggered the development of arms in NGC 4625.

  12. Acceptance Checklist for Clinical Effectiveness Pilot Trials: a systematic approach.

    OpenAIRE

    Charlesworth, G.; Burnell, K.; Hoe, J.; Orrell, M; Russell, I

    2013-01-01

    Conducting a pilot trial is important in preparing for, and justifying investment in, the ensuing larger trial. Pilot trials using the same design and methods as the subsequent main trial are ethically and financially advantageous especially when pilot and main trial data can be pooled. For explanatory trials in which internal validity is paramount, there is little room for variation of methods between the pilot and main trial. For pragmatic trials, where generalisability or external validity...

  13. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled

    DEFF Research Database (Denmark)

    Dahlöf, Björn; Sever, Peter S; Poulter, Neil R;

    2005-01-01

    The apparent shortfall in prevention of coronary heart disease (CHD) noted in early hypertension trials has been attributed to disadvantages of the diuretics and beta blockers used. For a given reduction in blood pressure, some suggested that newer agents would confer advantages over diuretics an...... and beta blockers. Our aim, therefore, was to compare the effect on non-fatal myocardial infarction and fatal CHD of combinations of atenolol with a thiazide versus amlodipine with perindopril....

  14. Evaluating the Effects of Aluminum-Containing and Non-Aluminum Containing Deodorants on Axillary Skin Toxicity During Radiation Therapy for Breast Cancer: A 3-Armed Randomized Controlled Trial

    Energy Technology Data Exchange (ETDEWEB)

    Lewis, Lucy, E-mail: Lucy.lewis@curtin.edu.au [Centre for Nursing Research, Sir Charles Gairdner Hospital, Nedlands, Western Australia (Australia); School of Nursing and Midwifery Curtin University, Perth (Australia); Carson, Sharron [Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia (Australia); Bydder, Sean [Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia (Australia); School of Surgery, The University of Western Australia, Crawley, Western Australia (Australia); Athifa, Mariyam [School of Nursing and Midwifery Curtin University, Perth (Australia); Williams, Anne M. [School of Nursing and Midwifery Curtin University, Perth (Australia); School of Nursing and Midwifery, Edith Cowan University, Perth, Western Australia (Australia); Bremner, Alexandra [School of Population Health, The University of Western Australia, Crawley, Western Australia (Australia)

    2014-11-15

    Purpose: Deodorant use during radiation therapy for breast cancer has been controversial as there are concerns deodorant use may exacerbate axillary skin toxicity. The present study prospectively determined the use of both aluminum-containing and non aluminum containing deodorants on axillary skin toxicity during conventionally fractionated postoperative radiation therapy for breast cancer. Methods and Materials: This 3-arm randomized controlled study was conducted at a single center, tertiary cancer hospital between March 2011 and April 2013. Participants were randomized to 1 of 2 experimental groups (aluminum-containing deodorant and soap or non–aluminum containing deodorant and soap) or a control group (soap). A total of 333 participants were randomized. Generalized estimating equations were used to estimate and compare the odds of experiencing high levels of sweating and skin toxicity in each of the deodorant groups to the odds in the control group. The study evaluated a range of endpoints including objective measurements of axilla sweating, skin toxicity, pain, itch and burning. Quality of life was assessed with a validated questionnaire. Results: Radiation characteristics were similar across all groups. Patients in the deodorant groups did not report significantly different ratings for axillary pain, itch, or burning compared with the control group. Patients in the aluminum-containing deodorant group experienced significantly less sweating than the control; the odds of their sweating being barely tolerable and frequently or always interfering with their daily activities was decreased by 85% (odds ratio, 0.15; 95% confidence interval, 0.03-0.91). Conclusions: We found no evidence that the use of either aluminum-containing or non–aluminum containing deodorant adversely effects axillary skin reaction during conventionally fractionated radiation therapy for breast cancer. Our analysis also suggests patients in the aluminum-containing deodorant arm had

  15. Evaluating the Effects of Aluminum-Containing and Non-Aluminum Containing Deodorants on Axillary Skin Toxicity During Radiation Therapy for Breast Cancer: A 3-Armed Randomized Controlled Trial

    International Nuclear Information System (INIS)

    Purpose: Deodorant use during radiation therapy for breast cancer has been controversial as there are concerns deodorant use may exacerbate axillary skin toxicity. The present study prospectively determined the use of both aluminum-containing and non aluminum containing deodorants on axillary skin toxicity during conventionally fractionated postoperative radiation therapy for breast cancer. Methods and Materials: This 3-arm randomized controlled study was conducted at a single center, tertiary cancer hospital between March 2011 and April 2013. Participants were randomized to 1 of 2 experimental groups (aluminum-containing deodorant and soap or non–aluminum containing deodorant and soap) or a control group (soap). A total of 333 participants were randomized. Generalized estimating equations were used to estimate and compare the odds of experiencing high levels of sweating and skin toxicity in each of the deodorant groups to the odds in the control group. The study evaluated a range of endpoints including objective measurements of axilla sweating, skin toxicity, pain, itch and burning. Quality of life was assessed with a validated questionnaire. Results: Radiation characteristics were similar across all groups. Patients in the deodorant groups did not report significantly different ratings for axillary pain, itch, or burning compared with the control group. Patients in the aluminum-containing deodorant group experienced significantly less sweating than the control; the odds of their sweating being barely tolerable and frequently or always interfering with their daily activities was decreased by 85% (odds ratio, 0.15; 95% confidence interval, 0.03-0.91). Conclusions: We found no evidence that the use of either aluminum-containing or non–aluminum containing deodorant adversely effects axillary skin reaction during conventionally fractionated radiation therapy for breast cancer. Our analysis also suggests patients in the aluminum-containing deodorant arm had

  16. Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network

    Science.gov (United States)

    A unique public-private collaboration today announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer. Squamous cell carcinom

  17. Hypnosis Antenatal Training for Childbirth (HATCh: a randomised controlled trial [NCT00282204

    Directory of Open Access Journals (Sweden)

    Baghurst Peter

    2006-03-01

    Full Text Available Abstract Background Although medical interventions play an important role in preserving lives and maternal comfort they have become increasingly routine in normal childbirth. This may increase the risk of associated complications and a less satisfactory birth experience. Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy. Methods/design A single centre, randomised controlled trial using a 3 arm parallel group design in the largest tertiary maternity unit in South Australia. Group 1 participants receive antenatal hypnosis training in preparation for childbirth administered by a qualified hypnotherapist with the use of an audio compact disc on hypnosis for re-enforcement; Group 2 consists of antenatal hypnosis training in preparation for childbirth using an audio compact disc on hypnosis administered by a nurse with no training in hypnotherapy; Group 3 participants continue with their usual preparation for childbirth with no additional intervention. Women > 34 and Discussion If effective, hypnosis would be a simple, inexpensive way to improve the childbirth experience, reduce complications associated with pharmacological interventions, yield cost savings in maternity care, and this trial will provide evidence to guide clinical practice.

  18. A sorrow shared is a sorrow halved? A three-arm randomized controlled trial comparing internet-based clinician-guided individual versus group treatment for social anxiety disorder.

    Science.gov (United States)

    Schulz, Ava; Stolz, Timo; Vincent, Alessia; Krieger, Tobias; Andersson, Gerhard; Berger, Thomas

    2016-09-01

    A growing body of evidence suggests that internet-based cognitive behavioural treatments (ICBT) are effective to treat social anxiety disorder (SAD). Whereas the efficacy of clinician-guided ICBT has been established, ICBT in a group format has not yet been systematically investigated. This three-arm RCT compared the efficacy of clinician-guided group ICBT (GT) with clinician guided individual ICBT (IT) and a wait-list (WL). A total of 149 individuals meeting the diagnostic criteria for SAD were randomly assigned to one of three conditions. Primary endpoints were self-report measures of SAD and diagnostic status taken at baseline, after the twelve-week intervention and at six-month follow-up. Secondary endpoints were symptoms of depression, interpersonal problems and general symptomatology. At post-treatment, both active conditions showed superior outcome regarding SAD symptoms (GT vs. WL: d = 0.84-0.74; IT vs. WL: d = 0.94-1.22). The two active conditions did not differ significantly in symptom reduction (d = 0.12-0.26, all ps > 0.63), diagnostic response rate or attrition. Treatment gains were maintained at follow-up. The group format reduced weekly therapist time per participant by 71% (IT: 17 min, GT: 5 min). Findings indicate that a clinician-guided group format is a promising approach in treating SAD. PMID:27423374

  19. Arm To Arm Interface Using Embedded C

    Directory of Open Access Journals (Sweden)

    Mohanraj.C

    2013-02-01

    Full Text Available Embedded systems are the most emerging field in these recent years. In this paper a different number of ARM processors (LPC2148 and LPC2378 are interconnected using C for distributed services. N numbers of processors are connected as the network and each processing devices are interlinked with each other, so that the each data that is processed by the devices and it can be used by the other device to activate their entire process. All the processed data’s are communicated to other device through Xbee interface card. LPC2148 and LPC2378 ARM processors are used in this prototype and winXtalk is used as a software terminal window. In this paper, the ultimate benefits of multiple processor interactions related to the embedded applications and design issues of processor interconnection are discussed. The features of multiple processor interaction in inter process communication and executions of embedded multitasking are also discussed. In modern embedded computing platform, embedded processor used in various applications like home automation, industrial control, medical system, access control, etc. In this paper, using embedded processor interactions, the several data communication is established.

  20. Probiotics in the treatment of acute rotavirus diarrhoea. A randomized, double-blind, controlled trial using two different probiotic preparations in Bolivian children

    Directory of Open Access Journals (Sweden)

    Grandy Giuseppe

    2010-08-01

    Full Text Available Abstract Background Evidence suggests that probiotics reduce rotavirus diarrhoea duration. Although there are several probiotic strains potentially useful, daily practice is often limited by the type and number of products locally available. In general, information about combined products is scarce. In this study we compare the effect of two probiotic products in the treatment of diarrhoea in children less than 2 years of age. Methods A Randomized double-blind controlled clinical trial in children hospitalized for acute rotavirus diarrhoea, in the Paediatric Centre Albina Patino, Cochabamba, Bolivia. Participants were children aged 1 - 23 months, who were randomly assigned to receive one of three treatments: Oral rehydration therapy plus placebo; Oral rehydration solution plus Saccharomyces boulardii; or Oral rehydration solution plus a compound containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum and Saccharomyces boulardii. Sample size was 20 per group and the outcomes were duration of diarrhoea, of fever, of vomiting and of hospitalization. Results 64 cases finished the protocol. On admission, patients' characteristics were similar. Median duration of diarrhoea (p = 0.04 in children who received the single species product (58 hours was shorter than in controls (84.5 hrs. Comparing children that received the single probiotic product and controls showed shorter duration of fever (18 vs 67 hrs (p = 0.0042 and the mixed probiotic of vomiting (0 vs 42.5 hrs (p = 0.041. There was no effect on duration of hospitalization (p = 0.31. When experimental groups were merged, statistical significance of changes increased (total duration of diarrhoea, fever and vomiting P = 0.025, P = 0.025 and P = 0.014, respectively. Conclusions Both products decreased the duration of diarrhoea compared to oral rehydration solution alone. This decrease was significant only for the single species product which also decreased the duration of

  1. Children In Armed Conflicts

    OpenAIRE

    Ranjan, Tejaswini

    2013-01-01

    This is a descriptive study. A child soldier is a child under the age of 18 that is recruited into the armed forces and engages in political violence. Child Soldiers are recruited by a state or non-state armed group and used as fighters, cooks, suicide bombers, human shields, messengers, spies, or for sexual purposes. This work of research describes the plight of child soldiers taking in context the scenario of different nations. The International mechanisms to combat this problem have also b...

  2. PHENIX Muon Arms

    International Nuclear Information System (INIS)

    The PHENIX Muon Arms detect muons at rapidities of |y|=(1.2-2.4) with full azimuthal acceptance. Each muon arm must track and identify muons and provide good rejection of pions and kaons (∼10-3). In order to accomplish this we employ a radial field magnetic spectrometer with precision tracking (Muon Tracker) followed by a stack of absorber/low resolution tracking layers (Muon Identifier). The design, construction, testing and expected run parameters of both the muon tracker and the muon identifier are described

  3. PHENIX Muon Arms

    Energy Technology Data Exchange (ETDEWEB)

    Akikawa, H.; Al-Jamel, A.; Archuleta, J.B.; Archuleta, J.R.; Armendariz, R.; Armijo, V.; Awes, T.C.; Baldisseri, A.; Barker, A.B.; Barnes, P.D.; Bassalleck, B.; Batsouli, S.; Behrendt, J.; Bellaiche, F.G.; Bland, A.W.; Bobrek, M.; Boissevain, J.G.; Borel, H.; Brooks, M.L.; Brown, A.W.; Brown, D.S.; Bruner, N.; Cafferty, M.M.; Carey, T.A.; Chai, J.-S.; Chavez, L.L.; Chollet, S.; Choudhury, R.K.; Chung, M.S.; Cianciolo, V.; Clark, D.J.; Cobigo, Y.; Dabrowski, C.M.; Debraine, A.; DeMoss, J.; Dinesh, B.V.; Drachenberg, J.L.; Drapier, O.; Echave, M.A.; Efremenko, Y.V.; En' yo, H.; Fields, D.E.; Fleuret, F.; Fried, J.; Fujisawa, E.; Funahashi, H.; Gadrat, S.; Gastaldi, F.; Gee, T.F.; Glenn, A.; Gogiberidze, G.; Gonin, M.; Gosset, J.; Goto, Y.; Granier de Cassagnac, R.; Hance, R.H.; Hart, G.W.; Hayashi, N.; Held, S.; Hicks, J.S.; Hill, J.C.; Hoade, R.; Hong, B.; Hoover, A.; Horaguchi, T.; Hunter, C.T.; Hurst, D.E.; Ichihara, T.; Imai, K.; Isenhower, L.D.L. Davis; Isenhower, L.D.L. Donald; Ishihara, M.; Jang, W.Y.; Johnson, J.; Jouan, D.; Kamihara, N.; Kamyshkov, Y.; Kang, J.H.; Kapoor, S.S.; Kim, D.J.; Kim, D.-W.; Kim, G.-B.; Kinnison, W.W.; Klinksiek, S.; Kluberg, L.; Kobayashi, H.; Koehler, D.; Kotchenda, L.; Kuberg, C.H.; Kurita, K.; Kweon, M.J.; Kwon, Y.; Kyle, G.S.; LaBounty, J.J.; Lajoie, J.G.; Lee, D.M.; Lee, S.; Leitch, M.J.; Li, Z.; Liu, M.X.; Liu, X.; Liu, Y.; Lockner, E.; Lopez, J.D.; Mao, Y.; Martinez, X.B.; McCain, M.C.; McGaughey, P.L.; Mioduszewski, S.; Mischke, R.E.; Mohanty, A.K.; Montoya, B.C.; Moss, J.M.; Murata, J.; Murray, M.M.; Nagle, J.L.; Nakada, Y.; Newby, J.; Obenshain, F.; Palounek, A.P.T.; Papavassiliou, V.; Pate, S.F.; Plasil, F.; Pope, K.; Qualls, J.M.; Rao, G.; Read, K.F. E-mail: readkf@ornl.gov; Robinson, S.H.; Roche, G.; Romana, A.; Rosnet, P.; Roth, R.; Saito, N.; Sakuma, T.; Sandhoff, W.F.; Sanfratello, L.; Sato, H.D.; Savino, R.; Sekimoto, M.; Shaw, M.R.; Shibata, T.-A.; Sim, K.S.; Skank, H.D.; Smith, D.E.; Smith, G.D. [and others

    2003-03-01

    The PHENIX Muon Arms detect muons at rapidities of |y|=(1.2-2.4) with full azimuthal acceptance. Each muon arm must track and identify muons and provide good rejection of pions and kaons ({approx}10{sup -3}). In order to accomplish this we employ a radial field magnetic spectrometer with precision tracking (Muon Tracker) followed by a stack of absorber/low resolution tracking layers (Muon Identifier). The design, construction, testing and expected run parameters of both the muon tracker and the muon identifier are described.

  4. Bio-preparates support the productivity of potato plants grown under desert farming conditions of north Sinai: Five years of field trials.

    Science.gov (United States)

    Abbas, Mohammed T; Hamza, Mervat A; Youssef, Hanan H; Youssef, Gehan H; Fayez, Mohamed; Monib, Mohamed; Hegazi, Nabil A

    2014-01-01

    Organic agriculture as well as good agricultural practices (GAPs) intrigues the concern of both consumers and producers of agricultural commodities. Bio-preparates of various rhizospheric microorganisms (RMOs) are potential sources of biological inputs supporting plant nutrition and health. The response of open-field potatoes to the application of RMO bio-preparates, the biofertilizer "Biofertile" and the bioagent "Biocontrol", were experimented over 5 successive years under N-hunger of north Sinai desert soils. Both vegetative and tuber yields of a number of tested cultivars were significantly improved due to rhizobacterial treatments. In the majority of cases, the biofertilizer "Biofertile" did successfully supply ca. 50% of plant N requirements, as the yield of full N-fertilized plants was comparable to those received 50% N simultaneously with bio-preparates treatment. The magnitude of inoculation was cultivar-dependent; cvs. Valor and Oceania were among the most responsive ones. Bio-preparate introduction to the plant-soil system was successful via soaking of tubers and/or spraying the plant canopy. The "Biocontrol" formulation was supportive in controlling plant pathogens and significantly increased the fruit yields. The cumulative effect of both bio-preparates resulted in tuber yield increases of ca. 25% over control. PMID:25685470

  5. Gender Differences in Cardiovascular Tolerance to Short Arm Centrifugation

    Science.gov (United States)

    Fong, Kevin J.; Arya, Maneesh; Paloski, William H.

    2007-01-01

    In preparation for the NASA Artificial Gravity (AG) pilot study, the tolerability of the proposed AG parameters was tested in 11 ambulatory human subjects (6m, 5w) by exposing each to a short arm centrifuge trial. Subjects were oriented in the supine position (but inclined 6deg head down) on one arm of the centrifuge, and the rotation rate (30.6-33.4 rpm) and radial position of the feet were set to produce 2.5G of equivalent gravitational load at the force plate directly beneath the feet, 1G at the level of the mediastinum, and approximately 0.55G at the labyrinth. Amongst the 6 men participating in this preliminary study, 5 completed at least 60 minutes of the trial successfully with no adverse sequelae. However, amongst the female cohort the test was stopped by the medical monitor before 60 min in all but one case, with pre-syncope listed as the reason for termination in all cases. Mean time before abort of the centrifuge run amongst the women was 33.2 +/- 20.97 min. It is known that women have a greater predisposition to syncope during orthostatic stress, under normal tilt table conditions, during LBNP, and following space flight. The reasons for this difference are the subject of some debate, but anthropometric factors, the vasoactive effects of sex hormones, gender differences in susceptibility to motion sickness, catecholamine levels, ability to augment total peripheral resistance in response to orthostatic stress, and structural differences in cardiac anatomy and physiology have all been suggested. This finding led to the exclusion of women from the AG pilot study. Clearly if AG is to be employed as a multi-system countermeasure it must provide physiological protection at rotation rates within the tolerance limits of all potential astronauts. Further investigation of the responses of women to centrifugation will be necessary to determine how to adjust AG parameters for tolerance by female subjects before a more detailed investigation of the appropriate dose

  6. Replantation (Finger, Hand, or Arm)

    Science.gov (United States)

    ... Symptom Picker Hand and Arm Conditions Carpal Tunnel Ganglion Cysts Trigger Finger Arthritis Base of the Thumb See ... Symptom Picker Hand and Arm Conditions Carpal Tunnel Ganglion Cysts Trigger Finger Arthritis Base of the Thumb See ...

  7. Modernization of African Armed Forces

    DEFF Research Database (Denmark)

    Mandrup, Thomas

    2015-01-01

    Concept paper framing the debate at the Dakar Forum Workshop on Modernization of Armed forces in Africa.......Concept paper framing the debate at the Dakar Forum Workshop on Modernization of Armed forces in Africa....

  8. Preparing Students for Class: A Clinical Trial Testing the Efficacy between Multimedia Pre-Lectures and Textbooks in an Economics Course

    Science.gov (United States)

    Vazquez, Jose J.; Chiang, Eric P.

    2016-01-01

    Motivating students to come prepared to class is often a futile exercise. The consequences are magnified as more instructors adopt the flipped classroom teaching model, in which students are expected to come to class with some knowledge of the material. This paper analyzed the implementation of a pedagogical tool that addresses this problem:…

  9. Effect of Sitagliptin and Metformin on Prediabetes Progression to Type 2 Diabetes - A Randomized, Double-Blind, Double-Arm, Multicenter Clinical Trial: Protocol for the Sitagliptin and Metformin in PreDiabetes (SiMePreD) Study

    Science.gov (United States)

    2016-01-01

    Background The high prevalence and incidence of type 2 diabetes mellitus (DM), and its associated morbidity and mortality, has prompted growing international interest and effort in the primary prevention of this disease. Primary prevention is possible since type 2 DM is preceded by prediabetes, offering a window opportunity to treat patients, and prevent the emergence of advanced disease. Sitagliptin is an oral dipeptidyl peptidase-IV inhibitor that preserves existing beta cell function and increases beta cell mass. These two effects have been demonstrated both in vitro and in animal studies, and current clinical data show that sitagliptin is safe. Metformin, a biguanide, reduces insulin resistance and inhibits hepatic gluconeogenesis, and has an excellent safety profile. The combination of metformin and sitagliptin, targeting both characteristics of prediabetes (insulin resistance and progressive beta cell degeneration), may potentially slow or halt the progression from prediabetes to type 2 DM. This paper describes the rationale and design of the Sitagliptin and Metformin in PreDiabetes (SiMePreD) study. Objective The aim of this study is to determine the effect of sitagliptin and metformin on progression from prediabetes to type 2 DM. The objectives of the study are to determine the effects of metformin and placebo on glycemic endpoints, the effects of sitagliptin and metformin on glycemic endpoints, the effects of metformin and placebo on incidence of cardiovascular disease and death, and the effects of sitagliptin and metformin on incidence of cardiovascular disease and death. Methods This is a randomized, double-blind, multicenter clinical study that will determine if the combination of metformin and sitagliptin is effective in preventing the progression from prediabetes to type 2 DM. The study will contain two arms (metformin/sitagliptin and metformin/placebo). Primary endpoints include the number of subjects progressing from prediabetes to type 2 DM, the

  10. Evaluation of computer-tailored health education (‘E-health4Uth’ combined with personal counselling (‘E-health4Uth + counselling’ on adolescents’ behaviours and mental health status: design of a three-armed cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Bannink Rienke

    2012-12-01

    Full Text Available Abstract Background About 15% of adolescents in the Netherlands have mental health problems and many also have health risk behaviours such as excessive alcohol consumption, cigarette smoking, use of drugs, and having unsafe sex. Mental health problems and health risk behaviours may have adverse effects on the short and longer term. Therefore, in the Netherlands there is a considerable support for an additional public health examination at age 15–16 years. The study evaluates the effect of two options for such an additional examination. Adolescents in the ‘E-health4Uth’ group receive internet-based tailored health messages on their health behaviour and well-being. Adolescents in the ‘E-health4Uth + counselling’ group receive the computer-tailored messages combined with personal counselling for adolescents at risk of mental health problems. Methods and design A three-arm cluster randomised controlled trial will be conducted in the Netherlands among fourth-grade secondary school students. School classes are the unit of randomisation. Both intervention groups complete the computer-tailored program during one class session; the program focuses on nine topics related on health behaviour and well-being. For each topic a score is computed that can be compared with the Dutch health norms for adolescents. Based on the score, a message is presented that reflects the person’s current behaviour or well-being, the Dutch health norm, and offers advise to change unhealthy behaviour or to talk to a person they trust. Adolescents in the ‘E-health4Uth + counselling’ group are also invited for an appointment to see the nurse when they are at risk of mental health problems. The control group receives ‘care as usual’. The primary outcome measures are health behaviour (alcohol, drugs, smoking, safe sex and mental health status. The secondary outcome measure is health-related quality of life. Data will be collected with a questionnaire at baseline

  11. Clinical Trials

    Science.gov (United States)

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

  12. Multi-Armed Bandits in Metric Spaces

    CERN Document Server

    Kleinberg, Robert; Upfal, Eli

    2008-01-01

    In a multi-armed bandit problem, an online algorithm chooses from a set of strategies in a sequence of trials so as to maximize the total payoff of the chosen strategies. While the performance of bandit algorithms with a small finite strategy set is quite well understood, bandit problems with large strategy sets are still a topic of very active investigation, motivated by practical applications such as online auctions and web advertisement. The goal of such research is to identify broad and natural classes of strategy sets and payoff functions which enable the design of efficient solutions. In this work we study a very general setting for the multi-armed bandit problem in which the strategies form a metric space, and the payoff function satisfies a Lipschitz condition with respect to the metric. We refer to this problem as the "Lipschitz MAB problem". We present a complete solution for the multi-armed problem in this setting. That is, for every metric space (L,X) we define an isometry invariant which bounds f...

  13. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial

    DEFF Research Database (Denmark)

    Dahlöf, Björn; Sever, Peter S; Poulter, Neil R;

    2005-01-01

    The apparent shortfall in prevention of coronary heart disease (CHD) noted in early hypertension trials has been attributed to disadvantages of the diuretics and beta blockers used. For a given reduction in blood pressure, some suggested that newer agents would confer advantages over diuretics an...

  14. Randomised controlled trial of short bursts of a potent topical corticosteroid versus prolonged use of a mild preparation for children with mild or moderate atopic eczema

    OpenAIRE

    Thomas, K.S.; Armstrong, S J; Avery, A J; Li Wan Po, A; O'Neill, C; Young, S.; Williams, H C

    2002-01-01

    Objective To determine whether a three day burst of a potent corticosteroid is more effective than a mild preparation used for seven days in children with mild or moderate atopic eczema. Design Randomised, double blind, parallel group study of 18 weeks' duration. Setting 13 general practices and a teaching hospital in the Nottingham area. Participants 174 children with mild or moderate atopic eczema recruited from general practices and 33 from a hospital outpatie...

  15. Arm insulation and swimming in cold water.

    Science.gov (United States)

    Lounsbury, David S; Ducharme, Michel B

    2008-09-01

    To test whether adding insulation to the arms would improve cold water swimming performance by delaying swimming failure (SF). Novice (n = 7) and expert (n = 8) swimmers, clothed and equipped with a personal flotation device, each performed two trials in a swimming flume filled with 10 degrees C water. During free swimming (FS), subjects performed swimming until failure, followed by the Heat Escape Lessening Posture. In free swimming with additional insulation (FSA), subjects wore custom-fitted armbands. Trials ended when rectal temperature decreased to 34 degrees C or after 2 h of immersion. Measurements included: rectal and skin temperatures, heat flow, and various appraisals of swimming performance. FSA was thermally advantageous versus FS. Rectal temperature cooling rates during swimming (dT/dt Swim) were faster for FS compared to FSA (0.050 +/- 0.007 degrees C min(-1) vs. 0.042 +/- 0.006 degrees C min(-1), P skin temperature about 10 degrees C warmer, for approximately 70 min (P stroke rate (6.6 str min(-1)) and decreases in stroke length (0.24 m str(-1)) observed. In this simulation of cold water swimming survival, equipping subjects with neoprene armbands appears to have partially preserved muscle function, but with unimpressive effects on overall performance. SF is a complex entity, but is evidently related to both triceps skinfold and arm girth. PMID:18309510

  16. Robot arm apparatus

    Science.gov (United States)

    Nachbar, Henry D.

    1992-01-01

    A robot arm apparatus is provided for inspecting and/or maintaining an interior of a steam generator which has an outside wall and a port for accessing the interior of the steam generator. The robot arm apparatus includes a flexible movable conduit for conveying inspection and/or maintenance apparatus from outside the steam generator to the interior of the steam generator. The flexible conduit has a terminal working end which is translated into and around the interior of the steam generator. Three motors located outside the steam generator are employed for moving the terminal working end inside the steam generator in "x", "y", and "z" directions, respectively. Commonly conducted inspection and maintenance operations include visual inspection for damaged areas, water jet lancing for cleaning sludge deposits, core boring for obtaining sludge deposits, and scrubbing of internal parts.

  17. Microelectromechanical safe arm device

    Energy Technology Data Exchange (ETDEWEB)

    Roesler, Alexander W. (Tijeras, NM)

    2012-06-05

    Microelectromechanical (MEM) apparatus and methods for operating, for preventing unintentional detonation of energetic components comprising pyrotechnic and explosive materials, such as air bag deployment systems, munitions and pyrotechnics. The MEM apparatus comprises an interrupting member that can be moved to block (interrupt) or complete (uninterrupt) an explosive train that is part of an energetic component. One or more latching members are provided that engage and prevent the movement of the interrupting member, until the one or more latching members are disengaged from the interrupting member. The MEM apparatus can be utilized as a safe and arm device (SAD) and electronic safe and arm device (ESAD) in preventing unintentional detonations. Methods for operating the MEM apparatus include independently applying drive signals to the actuators coupled to the latching members, and an actuator coupled to the interrupting member.

  18. Kiikuv maja / Anu Arm

    Index Scriptorium Estoniae

    Arm, Anu

    2006-01-01

    Eesti Kunstiakadeemia esimese kursuse arhitektuuriüliõpilaste II semestri töö. Juhendaja arhitekt Andres Alver, ehitamise Pedaspeale organiseeris suvepraktika juhendaja arhitekt Jaan Tiidemann. Autor Anu Arm, kaasa töötasid ja valmis ehitasid: Ott Alver, Maarja Elm, Mari Hunt, Alvin Järving, Marten Kaevats, Riho Kerge, Reedik Poopuu, Anu Põime, Helen Rebane, Kaisa Saarva, Martin Tago, Reet Volt. Valmis: 19. VIII 2006

  19. Gerbils exhibit stable open-arms exploration across repeated testing on the elevated plus-maze.

    Science.gov (United States)

    Rico, Javier Leonardo; Penagos-Gil, Marion; Castañeda, Anderson F; Corredor, Karen

    2016-01-01

    Repeated testing on the elevated plus-maze (EPM) leads rats and mice to avoid the open-arms of the apparatus. The effect of multiple exposures to the EPM on the behavioral profile of gerbils is unknown. In this study, young and middle-aged gerbils were exposed to the EPM and four retests were carried out 24, 48, 72 and 96h after the first trial in order to determine whether animals exhibited open-arms avoidance. In addition, groups of young and middle-aged gerbils were exposed to the EPM for 20-min followed by a 5-min retest trial 24h apart to analyze the effect of a prolonged exposure to the EPM on open-arms exploration during first trial and retest. Gerbils exhibited high exploration of open-arms during the first trial and progressive locomotor decrease across repeated testing. Unlike previous reports for rats and mice, young gerbils showed a stable open-arms exploration both across multiple exposures and during a prolonged exposure to EPM. Middle-aged gerbils also exhibited a stable open-arms exploration during retest prior to the 20-min test. Results suggest a reliable repeated test paradigm for the EPM using our proposed methodology for gerbils. PMID:26621258

  20. Amorphous Solid Simulation and Trial Fabrication of the Organic Field-Effect Transistor of Tetrathienonaphthalenes Prepared by Using Microflow Photochemical Reactions: A Theoretical Calculation-Inspired Investigation.

    Science.gov (United States)

    Yamamoto, Atsushi; Matsui, Yasunori; Asada, Toshio; Kumeda, Motoki; Takagi, Kenichiro; Suenaga, Yu; Nagae, Kunihiko; Ohta, Eisuke; Sato, Hiroyasu; Koseki, Shiro; Naito, Hiroyoshi; Ikeda, Hiroshi

    2016-04-15

    The p-type organic semiconductor (OSC) material tetrathieno[2,3-a:3',2'-c:2″,3″-f:3‴,2‴-h]naphthalene (2TTN) and its alkyl-substituted derivatives Cn-2TTNs (n = 6, 8, and 10) have been developed based on the results of theoretical calculation-inspired investigation. A hole mobility for amorphous Cn-2TTNs (10(-2)-10(-3) cm(2) V(-1) s(-1)) was accurately predicted by using a novel statistical method in which the geometric mean of the mobilities for many individual small molecular flocks in an amorphous solid was obtained by using molecular mechanical molecular dynamics simulations and quantum chemical calculations. The simulation also suggests that upon increasing the length of alkyl chains in Cn-2TTNs the mobilities become smaller as a consequence of a decrease in transfer integral values. Cn-2TTNs are synthesized in a microflow reactor through photoreactions of the corresponding precursors. Cn-2TTNs are then utilized in the fabrication of organic field-effect transistors (OFETs). Although spin-coated thin films of Cn-2TTNs are crystalline, the hole mobilities (10(-2)-10(-3) cm(2) V(-1) s(-1)) of trial OFETs decrease upon elongation of the alkyl chains. This finding parallels the results of theoretical simulation. The simulation method for amorphous solids developed in this effort should become a useful tool in studies aimed at designing new OSC materials. PMID:27010327

  1. Results from a 1-year, open-label, single arm, multi-center trial evaluating the efficacy and safety of oral Deferasirox in patients diagnosed with low and int-1 risk myelodysplastic syndrome (MDS) and transfusion-dependent iron overload.

    Science.gov (United States)

    Nolte, F; Höchsmann, B; Giagounidis, A; Lübbert, M; Platzbecker, U; Haase, D; Lück, A; Gattermann, N; Taupitz, M; Baier, M; Leismann, O; Junkes, A; Schumann, C; Hofmann, W K; Schrezenmeier, H

    2013-01-01

    The majority of patients with myelodysplastic syndrome (MDS) present with anemia and will become dependent on regular transfusions of packed red blood cells (PRBC) with the risk of iron overload (IOL). Liver iron content best reflects the total body iron content, and measurement of liver iron concentration (LIC) by MRI is a validated tool for detection, but data in MDS is rather limited. Here we present the results of a multi-center trial evaluating the efficacy and safety of deferasirox (DFX) in low and intermediate-1 risk MDS patients with transfusion-dependent IOL. Three patients with transfusion frequency of > 4 units PRBC per month were initially treated with 30 mg/kg/day while in 46 patients with a lower transfusion burden deferasirox was initiated at 20 mg/kg/day, due to patient related reasons one patient received DFX in a dose of 6 mg/kg/day only. LIC was measured by MRI at baseline and end of study using the method by St. Pierre et al. The intention to treat population consisted of 50 MDS patients (28 male; 22 female) with a median age of 69 years who were treated with DFX for a median duration of 354 days. Mean daily dose of DFX was 19 mg/kg/day. Median serum ferritin level (SF) at baseline was 2,447 ng/mL and decreased to 1,685 ng/mL (reduction by 31 %) at end of study (p = 0.01). In 7 (13 %) patients the initially chosen dose had to be increased due to unsatisfactory efficacy of chelation therapy. For 21 patients, LIC measurement by liver MRI was performed at baseline and for 19 of these patients at the end of study: mean LIC decreased significantly from 16,8 mg/g dry tissue weight (± 8.3 mg/g dry tissue weight) at study entry to 10,8 mg/g dry tissue weight (± 10.4 mg/g dry tissue weight) at end of study (p = 0.01). Of all patients exposed to the study drug (n = 54), 28 (52 %) did not complete the 12 month study period most commonly due to AEs in 28 % (n = 15) and abnormal laboratory values in 7 % (n = 4

  2. Pragmatic trials in primary care. Methodological challenges and solutions demonstrated by the DIAMOND-study

    Directory of Open Access Journals (Sweden)

    Samsom Melvin

    2007-04-01

    Full Text Available Abstract Background Pragmatic randomised controlled trials are often used in primary care to evaluate the effect of a treatment strategy. In these trials it is difficult to achieve both high internal validity and high generalisability. This article will discuss several methodological challenges in designing and conducting a pragmatic primary care based randomised controlled trial, based on our experiences in the DIAMOND-study and will discuss the rationale behind the choices we made. From the successes as well as the problems we experienced the quality of future pragmatic trials may benefit. Discussion The first challenge concerned choosing the clinically most relevant interventions to compare and enable blinded comparison, since two interventions had very different appearances. By adding treatment steps to one treatment arm and adding placebo to both treatment arms both internal and external validity were optimized. Nevertheless, although blinding is essential for a high internal validity, it should be warily considered in a pragmatic trial because it decreases external validity. Choosing and recruiting a representative selection of participants was the second challenge. We succeeded in retrieving a representative relatively large patient sample by carefully choosing (few inclusion and exclusion criteria, by random selection, by paying much attention to participant recruitment and taking the participant's reasons to participate into account. Good and regular contact with the GPs and patients was to our opinion essential. The third challenge was to choose the primary outcome, which needed to reflect effectiveness of the treatment in every day practice. We also designed our protocol to follow every day practice as much as possible, although standardized treatment is usually preferred in trials. The aim of this was our fourth challenge: to limit the number of protocol deviations and increase external validity. Summary It is challenging to design

  3. Preparing Your Family for a New Baby

    Science.gov (United States)

    ... overwhelmed, look to your spouse, other relatives, and friends for support and an extra set of arms. Other ideas to help prepare your very young child for a new sibling include Look at picture books about a new ...

  4. Supporting the President's Arms Control and Nonproliferation Agenda: Transparency and Verification for Nuclear Arms Reductions

    International Nuclear Information System (INIS)

    The President's arms control and nonproliferation agenda is still evolving and the details of initiatives supporting it remain undefined. This means that DOE, NNSA, NA-20, NA-24 and the national laboratories can help define the agenda, and the policies and the initiatives to support it. This will require effective internal and interagency coordination. The arms control and nonproliferation agenda is broad and includes the path-breaking goal of creating conditions for the elimination of nuclear weapons. Responsibility for various elements of the agenda will be widely scattered across the interagency. Therefore an interagency mapping exercise should be performed to identify the key points of engagement within NNSA and other agencies for creating effective policy coordination mechanisms. These can include informal networks, working groups, coordinating committees, interagency task forces, etc. It will be important for NA-20 and NA-24 to get a seat at the table and a functional role in many of these coordinating bodies. The arms control and nonproliferation agenda comprises both mature and developing policy initiatives. The more mature elements such as CTBT ratification and a follow-on strategic nuclear arms treaty with Russia have defined milestones. However, recent press reports indicate that even the START follow-on strategic arms pact that is planned to be complete by the end of 2009 may take significantly longer and be more expansive in scope. The Russians called for proposals to count non-deployed as well as deployed warheads. Other elements of the agenda such as FMCT, future bilateral nuclear arms reductions following a START follow-on treaty, nuclear posture changes, preparations for an international nuclear security summit, strengthened international safeguards and multilateral verification are in much earlier stages of development. For this reason any survey of arms control capabilities within the USG should be structured to address potential needs across the

  5. Phase II, two-arm RTOG trial (94-11) of bischloroethyl-nitrosourea plus accelerated hyperfractionated radiotherapy (64.0 or 70.4 Gy) based on tumor volume (> 20 or ≤ 20 cm2, respectively) in the treatment of newly-diagnosed radiosurgery-ineligible glioblastoma multiforme patients

    International Nuclear Information System (INIS)

    Purpose: To compare survivorship, and acute and delayed toxicities following radiation therapy (RT) of radiosurgery-ineligible glioblastoma multiforme (GBM) patients treated with tumor volume-influenced, high-dose accelerated, hyperfractionated RT plus bischloroethyl-nitrosourea (BCNU), using prior RTOG malignant glioblastoma patients as historical controls. Methods and Materials: One hundred four of 108 patients accrued from June 1994 through May 1995 from 26 institutions were analyzable. Patients were histologically confirmed with GBM, and previously untreated. Treatment assignment (52 patients/arm) was based on tumor mass (TM), defined as the product of the maximum diameter and greatest perpendicular dimension of the titanium-gadolinium-enhanced postoperative MRI: Arm A, 64 Gy, TM > 20 cm2; or Arm B, 70.4 Gy, TM ≤ 20 cm2. Both Arms A and B received BCNU (80 mg/m2, under hyperhydration) days 1-3, 56-58, then 4 cycles, each 8 weeks, for a total of 6 treatment series. Results: During the 24 months immediately post-treatment, the overall median survival was 9.1 months in Arm A (64 Gy) and 11.0 months in Arm B (70.4 Gy). Median survival in recursive partitioning analysis (RPA) Class III/IV was 10.4 months in Arm A and 12.2 months in Arm B, while RPA Class V/VI was 7.6 months in Arm A and 6.1 months in Arm B. There were no grade 4 neurological toxicities in Arm A; 2 grade 4 neurological toxicities were observed in Arm B (1 motor deficit, 1 necrosis at 157 days post-treatment). Conclusion: This strategy of high-dose, accelerated hyperfractionated radiotherapy shortens overall RT treatment times while allowing dose escalation, and it provides the potential for combination with currently available, as well as newer, chemotherapy agents. Survival is comparable with previously published RTOG data, and toxicities are within acceptable limits.

  6. Disarmament and arms control

    International Nuclear Information System (INIS)

    This report discusses how far science and technology can provide methods of making arms control and disarmament agreements more controlable in an objective way. Two case studies have been considered, the test ban treaty and the verification of the number of strategic nuclear weapons. These lead to the conclusion that both science and politics are closely interwoven and that within what appear to be scientific arguments, political positions are being defended. Consequently scientists and technologists and the contexts in which they work, play a prominent role. (C.F.)

  7. Removable molar power arm

    OpenAIRE

    2013-01-01

    Attachment of force elements from the gingival hook of maxillary molar tubes during the retraction of the anterior teeth is very common in orthodontic practice. As the line of force passes below the center of resistance (CR) of molar, it results its mesial tipping and also anchorage loss. To overcome this problem, the line of force should pass along the CR of molar. This article highlights a method to overcome this problem by attaching a removable power arm to the headgear tube of molar tube ...

  8. Nuclear disarmament or survival of nuclear arms?

    International Nuclear Information System (INIS)

    START II has not yet been ratified by the US or Russian parliaments. Doubts may be raised over whether it will ever be. In the best case there will be more than 20,000 nuclear warheads in the arsenals of these two countries by the year 2003. All five nuclear states consider that nuclear weapons are an essential component of their national defense. It might sound childish but, the whole story is is so often childish: the five powers refuse to break their nuclear toys. They take even all possible measures to maintain and improve them and to ensure the survivability of their arsenals. To prepare for the next arms race..

  9. A response adaptive randomization platform trial for efficient evaluation of Ebola virus treatments: A model for pandemic response.

    Science.gov (United States)

    Berry, Scott M; Petzold, Elizabeth A; Dull, Peter; Thielman, Nathan M; Cunningham, Coleen K; Corey, G Ralph; McClain, Micah T; Hoover, David L; Russell, James; Griffiss, J McLeod; Woods, Christopher W

    2016-02-01

    The outbreak of Ebola virus disease in West Africa is the largest ever recorded. Numerous treatment alternatives for Ebola have been considered, including widely available repurposed drugs, but initiation of enrollment into clinical trials has been limited. The proposed trial is an adaptive platform design. Multiple agents and combinations will be investigated simultaneously. Additionally, new agents may enter the trial as they become available, and failing agents may be removed. In order to accommodate the many possible agents and combinations, a critical feature of this design is the use of response adaptive randomization to assign treatment regimens. As the trial progresses, the randomization ratio evolves to favor the arms that are performing better, making the design also suitable for all-cause pandemic preparedness planning. The study was approved by US and Sierra Leone ethics committees, and reviewed by the US Food and Drug Administration. Additionally, data management, drug supply lines, and local sites were prepared. However, in response to the declining epidemic seen in February 2015, the trial was not initiated. Sierra Leone remains ready to rapidly activate the protocol as an emergency response trial in the event of a resurgence of Ebola. (ClinicalTrials.gov Identifier: NCT02380625.) In summary, we have designed a single controlled trial capable of efficiently identifying highly effective or failing regimens among a rapidly evolving list of proposed therapeutic alternatives for Ebola virus disease and to treat the patients within the trial effectively based on accruing data. Provision of these regimens, if found safe and effective, would have a major impact on future epidemics by providing effective treatment options. PMID:26768569

  10. Initial formal toxicity evaluation of APC-2, a novel fluorescent tracer agent for real-time measurement of glomerular filtration rate in preparation for a first-in-man clinical trial

    Science.gov (United States)

    Bugaj, Joseph E.; Dorshow, Richard B.

    2014-03-01

    The fluorescent tracer agent 2,5-bis[N-(1-carboxy-2-hydroxy)]carbamoyl-3,6-diaminopyrazine, designated APC-2, has been developed with properties and attributes necessary for use as a direct measure of glomerular filtration rate (GFR). Comparison to known standard exogenous GFR agents in animal models has demonstrated an excellent correlation. A clinical trial to demonstrate this same correlation in humans is in preparation. A battery of formal toxicity tests necessary for regulatory clearance to proceed with a clinical trial has been recently completed on this new fluorescent tracer agent. These include single dose toxicity studies in rats and dogs to determine overall toxicity and toxicokinetics of the compound. Blood compatibility, mutation assay, chromosomal aberration assay, and several other assays were also completed. Toxicity assessments were based on mortality, clinical signs, body weight, food consumption and anatomical pathology. Blood samples were collected to assess pharmacokinetic parameters including half-life, area under the curve, and clearance. Urine samples were collected to assess distribution. Doses of up to 200-300 times the estimated human dose were administered. No test-article related effects were noted on body weight, food consumption, ophthalmic observations and no abnormal pathology was seen in either macroscopic or microscopic evaluations of any organs or tissues. All animals survived to scheduled sacrifice. Transient discoloration of skin and urine was noted at the higher dose levels in both species as expected from a highly fluorescent compound and was not considered pathological. Thus initial toxicology studies of this new fluorescent tracer agent APC-2 have resulted in no demonstrable pathological test article concerns.

  11. X-Armed Bandits

    CERN Document Server

    Bubeck, Sébastien; Stoltz, Gilles; Szepesvari, Csaba

    2010-01-01

    We consider a generalization of stochastic bandits where the set of arms, $\\cX$, is allowed to be a generic measurable space and the mean-payoff function is "locally Lipschitz" with respect to a dissimilarity function that is known to the decision maker. Under this condition we construct an arm selection policy, called HOO hierarchical optimistic optimization), with improved regret bounds compared to previous results for a large class of problems. In particular, our results imply that if $\\cX$ is the unit hypercube in a Euclidean space and the mean-payoff function has a finite number of global maxima around which the behavior of the function is locally H\\"older continuous with a known exponent, then the expected of HOO regret is bounded up to a logarithmic factor by $\\sqrt{n}$, i.e., the rate of growth of the regret is independent of the dimension of the space. We also prove the minimax optimality of our algorithm when the dissimilarity is a metric.

  12. The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial

    OpenAIRE

    Forster Anne; Young John; Barber Sally; Clegg Andrew; Iliffe Steve

    2011-01-01

    Abstract Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE) trial is a two arm, assessor blind pilot randomised controlled trial (RCT) to a...

  13. The FOCUS trial

    DEFF Research Database (Denmark)

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

    2015-01-01

    BACKGROUND: Cognitive deficits are a distinct feature among people at ultra-high risk (UHR) for psychosis and pose a barrier to functional recovery. Insufficient evidence exists on how to ameliorate these cognitive deficits in patients at UHR for psychosis and hence improve daily living and quality...... the cognitive training to their everyday lives. Follow-up assessments will be conducted at 6 and 12 months after randomisation. The primary outcome is the composite score on the Brief Assessment of Cognition in Schizophrenia at cessation of treatment after 6 months. Secondary outcomes are social and......-blinded clinical trial enrolling 126 patients meeting the standardised criteria of being at UHR for psychosis. Patients are recruited from psychiatric in- and outpatient facilities in the Copenhagen catchment area. Patients are randomised to one of the two treatment arms: cognitive remediation plus standard...

  14. LISA Long-Arm Interferometry

    Science.gov (United States)

    Thorpe, James I.

    2009-01-01

    An overview of LISA Long-Arm Interferometry is presented. The contents include: 1) LISA Interferometry; 2) Constellation Design; 3) Telescope Design; 4) Constellation Acquisition; 5) Mechanisms; 6) Optical Bench Design; 7) Phase Measurement Subsystem; 8) Phasemeter Demonstration; 9) Time Delay Interferometry; 10) TDI Limitations; 11) Active Frequency Stabilization; 12) Spacecraft Level Stabilization; 13) Arm-Locking; and 14) Embarassment of Riches.

  15. Poly(glycolide multi-arm star polymers: Improved solubility via limited arm length

    Directory of Open Access Journals (Sweden)

    Florian K. Wolf

    2010-06-01

    Full Text Available Due to the low solubility of poly(glycolic acid (PGA, its use is generally limited to the synthesis of random copolyesters with other hydroxy acids, such as lactic acid, or to applications that permit direct processing from the polymer melt. Insolubility is generally observed for PGA when the degree of polymerization exceeds 20. Here we present a strategy that allows the preparation of PGA-based multi-arm structures which significantly exceed the molecular weight of processable oligomeric linear PGA (<1000 g/mol. This was achieved by the use of a multifunctional hyperbranched polyglycerol (PG macroinitiator and the tin(II-2-ethylhexanoate catalyzed ring-opening polymerization of glycolide in the melt. With this strategy it is possible to combine high molecular weight with good molecular weight control (up to 16,000 g/mol, PDI = 1.4–1.7, resulting in PGA multi-arm star block copolymers containing more than 90 wt % GA. The successful linkage of PGA arms and PG core via this core first/grafting from strategy was confirmed by detailed NMR and SEC characterization. Various PG/glycolide ratios were employed to vary the length of the PGA arms. Besides fluorinated solvents, the materials were soluble in DMF and DMSO up to an average arm length of 12 glycolic acid units. Reduction in the Tg and the melting temperature compared to the homopolymer PGA should lead to simplified processing conditions. The findings contribute to broadening the range of biomedical applications of PGA.

  16. Multijoint arm stiffness during movements following stroke: implications for robot therapy

    Science.gov (United States)

    Piovesan, D.; Casadio, M.; Mussa-Ivaldi, F. A.; Morasso, P.G

    2015-01-01

    Impaired arm movements in stroke appear as a set of stereotypical kinematic patterns, characterized by abnormal joint coupling, which have a direct consequence on arm mechanics and can be quantified by the net arm stiffness at the hand. The current available measures of arm stiffness during functional tasks have limited clinical use, since they require several repetitions of the same test movement in many directions. Such procedure is difficult to obtain in stroke survivors who have lower fatigue threshold and increased variability compared to unimpaired individuals. The present study proposes a novel, fast quantitative measure of arm stiffness during movements by means of a Time-Frequency technique and the use of a reassigned spectrogram, applied on a trial-by-trial basis with a single perturbation. We tested the technique feasibility during robot mediated therapy, where a robot helped stroke survivors to regain arm mobility by providing assistive forces during a hitting task to 13 targets covering the entire reachable workspace. The endpoint stiffness of the paretic arm was estimated at the end of each hitting movements by suddenly switching of the assistive forces and observing the ensuing recoil movements. In addition, we considered how assistive forces influence stiffness. This method will provide therapists with improved tools to target the treatment to the individual’s specific impairment and to verify the effects of the proposed exercises. PMID:22275576

  17. Nuclear arms cleanup

    International Nuclear Information System (INIS)

    The Soviet Union's demise five years ago brought an end to the Cold War, the 45-year arms race between the Soviet superpower and the United States. The euphoria that greeted the end of this bloodless conflict has dampened somewhat, however, as U.S. officials and their counterparts in the former Soviet republics come to grips with its legacy: thousands of highly toxic and politically destabilizing nuclear weapons. With no more perceived need for much of their vast arsenals, the governments have agreed to dismantle large numbers of nuclear warheads. But the agencies involved in this task face a daunting technical and political problem: what to do with the thousands of tons of plutonium and uranium that are the main ingredients of nuclear weapons

  18. Physical Activity, Function, and Quality of Life: Design and Methods of the FlexToBa™ Trial

    OpenAIRE

    McAuley, Edward; Wójcicki, Thomas R.; White, Siobhan M.; Mailey, Emily L; Szabo, Amanda N.; Gothe, Neha; Olson, Erin A.; Mullen, Sean P.; Fanning, Jason; Motl, Robert W.; Rosengren, Karl; Estabrooks, Paul

    2011-01-01

    The Flexibility, Toning, and Balance (FlexToBa™) Trial is a two-armed randomized controlled trial which will contrast the effects of a DVD-delivered, home-based, physical activity intervention and a Healthy Aging attention control condition on physical activity, functional performance, functional limitations, and quality of life in low active, older adults. This innovative trial will recruit 300 participants across central Illinois who will be randomized into the intervention arm or control a...

  19. Lethal Prostate Cancer in the PLCO Cancer Screening Trial.

    Science.gov (United States)

    Shoag, Jonathan; Mittal, Sameer; Halpern, Joshua A; Scherr, Douglas; Hu, Jim C; Barbieri, Christopher E

    2016-07-01

    The Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial randomized men to usual care or annual prostate-specific antigen (PSA) screening for 6 yr and digital rectal examination for 4 yr. This trial found no difference between the intervention and usual care arms of the study in the primary end point of prostate cancer (PCa)-specific mortality. The PLCO trial results have had a major impact on health policy and the rate of PSA screening in the United States. We analyzed the 13-yr screening and outcomes data from the 151 participants who died of PCa in the screening arm of the trial to better understand how randomization to screening failed to prevent PCa death in these men. We found that of these men, 81 (53.6%) either were never screened as part of the trial or had an initial positive screen. Only 17 (11.3%) of those who died reached year 6 of the trial with a PSA <4.0 ng/ml. The men who died in the screening arm were also older at study entry than the average PLCO participant (66 vs 62 yr; p < 0.001). Our analysis should inform the interpretation of the PLCO trial and provide insight into future trial design. PMID:27166670

  20. International security and arms control

    International Nuclear Information System (INIS)

    The end of the cold war also ended the focus on the bilateral approach to arms control and disarmament. Key concepts of security needed to be revisited, along with their implications for the disarmament and arms control agenda. Though there is currently a unipolar global security environment, there remain important tasks on the multilateral arms control agenda. The major task is that of reducing and eliminating weapons of mass destruction, especially nuclear weapons. The author contends that maintaining reliance on the nuclear-weapons option makes little sense in a time when the major Powers are strengthening their partnerships in economics, trade, peacemaking and building. (author)

  1. ARM Lead Mentor Selection Process

    Energy Technology Data Exchange (ETDEWEB)

    Sisterson, DL

    2013-03-13

    The ARM Climate Research Facility currently operates more than 300 instrument systems that provide ground-based observations of the atmospheric column. To keep ARM at the forefront of climate observations, the ARM infrastructure depends heavily on instrument scientists and engineers, also known as Instrument Mentors. Instrument Mentors must have an excellent understanding of in situ and remote-sensing instrumentation theory and operation and have comprehensive knowledge of critical scale-dependent atmospheric processes. They also possess the technical and analytical skills to develop new data retrievals that provide innovative approaches for creating research-quality data sets.

  2. Optimal Design of Cluster Randomized Trials with Binary Outcomes

    OpenAIRE

    Wu, Sheng

    2015-01-01

    Cluster randomized trials (CRTs) are increasingly used in many fields including public health and medicine. We consider two-arm CRTs with binary outcomes with possibly unequal intraclass correlations coefficients (ICCs) in the two arms. The efficacy of the intervention may be measured in terms of the risk difference (RD), relative risk (RR) or odds ratio (OR). We define cost efficiency (CE) as the ratio of the precision of the efficacy measure to the study cost and develop optimal allocations...

  3. Stroke Trials Registry

    Science.gov (United States)

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

  4. NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) Trial

    Science.gov (United States)

    NCI's gateway for information about the NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) trial, in which patients with advanced cancer are assigned to treatment arms based on the molecular profiles of their disease.

  5. Being Prepared

    Institute of Scientific and Technical Information of China (English)

    Francois Essomba

    2011-01-01

    WITH the propensity for armed conflict high in Africa,the African Union (AU) has established an African Standby Force (ASF) to assist in preventing armed conflict or restore peace where war has broken out on the continent.Douala,Cameroon's economic capital,is to be the ASF's military base.

  6. Arms control: misplaced focus

    Energy Technology Data Exchange (ETDEWEB)

    Schwartz, W.A.; Derber, C.

    1986-03-01

    Most of the nuclear debate consists of arguments about which weapons systems should be built, controlled, canceled, frozen, or retired. Short of virtually complete, multilateral nuclear disarmament, however, no change in the pace, balance, or even the direction of the arms race can make much difference in the risk of nuclear war, the damage should one occur, or the division of international political power. This includes Star Wars, the nuclear freeze, and even large cuts in or stabilization of offensive nuclear arsenals. A better starting point for nuclear politics would be the insight that nuclear weapons have completely changed the logic of power as it has been handed down through the ages. Military force, perfected to its highest level, has invalidated itself - for in a nuclearized world, any resort to force by a nuclear power risks escalation to its ultimate level, and thus to oblivion for all. Trying to rationalize and control the ultimate force is far less realistic and important than limiting the provocation of conflict and the use of force at lower, non-nuclear levels - by the United States, it clients, and, to the extent possible, its adversaries. 13 references.

  7. ARM Standards Policy Committee Report

    Energy Technology Data Exchange (ETDEWEB)

    Cialella, A; Jensen, M; Koontz, A; McFarlane, S; McCoy, R; Monroe, J; Palanisamy, G; Perez, R; Sivaraman, C

    2012-09-19

    Data and metadata standards promote the consistent recording of information and are necessary to ensure the stability and high quality of Atmospheric Radiation Measurement (ARM) Climate Research Facility data products for scientific users. Standards also enable automated routines to be developed to examine data, which leads to more efficient operations and assessment of data quality. Although ARM Infrastructure agrees on the utility of data and metadata standards, there is significant confusion over the existing standards and the process for allowing the release of new data products with exceptions to the standards. The ARM Standards Policy Committee was initiated in March 2012 to develop a set of policies and best practices for ARM data and metadata standards.

  8. Torque-Wrench Extension Arm

    Science.gov (United States)

    Pacala, T. J.; Trujillo, D. D.; Laudenslager, J. B.

    1984-01-01

    Torque-wrench extension arm makes possible to apply torque to bolt, screw, or nut inaccessible to conventional wrenches or in areas where wrench cannot be manipulated. Used in narrow pockets and behind panels and walls.

  9. 21 CFR 890.3640 - Arm sling.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Arm sling. 890.3640 Section 890.3640 Food and... PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3640 Arm sling. (a) Identification. An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric...

  10. 49 CFR 234.223 - Gate arm.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Gate arm. 234.223 Section 234.223 Transportation... Maintenance Standards § 234.223 Gate arm. Each gate arm, when in the downward position, shall extend across... clearly viewed by approaching highway users. Each gate arm shall start its downward motion not less...

  11. Patterns of motor activity in the isolated nerve cord of the octopus arm.

    Science.gov (United States)

    Gutfreund, Yoram; Matzner, Henry; Flash, Tamar; Hochner, Binyamin

    2006-12-01

    The extremely flexible octopus arm provides a unique opportunity for studying movement control in a highly redundant motor system. We describe a novel preparation that allows analysis of the peripheral nervous system of the octopus arm and its interaction with the muscular and mechanosensory elements of the arm's intrinsic muscular system. First we examined the synaptic responses in muscle fibers to identify the motor pathways from the axial nerve cord of the arm to the surrounding musculature. We show that the motor axons project to the muscles via nerve roots originating laterally from the arm nerve cord. The motor field of each nerve is limited to the region where the nerve enters the arm musculature. The same roots also carry afferent mechanosensory information from the intrinsic muscle to the axial nerve cord. Next, we characterized the pattern of activity generated in the dorsal roots by electrically stimulating the axial nerve cord. The evoked activity, although far reaching and long lasting, cannot alone account for the arm extension movements generated by similar electrical stimulation. The mismatch between patterns of activity in the isolated cord and in an intact arm may stem from the involvement of mechanosensory feedback in natural arm extension. PMID:17179381

  12. Combinatorial Multi-Armed Bandit and Its Extension to Probabilistically Triggered Arms

    OpenAIRE

    Chen, Wei; Wang, Yajun; Yuan, Yang; Wang, Qinshi

    2014-01-01

    We define a general framework for a large class of combinatorial multi-armed bandit (CMAB) problems, where subsets of base arms with unknown distributions form super arms. In each round, a super arm is played and the base arms contained in the super arm are played and their outcomes are observed. We further consider the extension in which more based arms could be probabilistically triggered based on the outcomes of already triggered arms. The reward of the super arm depends on the outcomes of...

  13. The Randomized Controlled Trial on Preoperative Intestinal Antibiotics Preparation in Colorectal Cancer%结直肠癌术前肠道抗菌准备与否的随机对照研究

    Institute of Scientific and Technical Information of China (English)

    门树成; 黄宝俊; 徐惠绵

    2014-01-01

    Objective:To assess the necessity of preoperative intestinal preparation using oral antibiotic in colorectal cancer. Method:Selection from June 2011 to June 2012,the first hospital affiliated to China medical university at the records of 100 patients with colorectal cancer surgical oncology,using the random number table method divided into trial group and control group,50 cases each. Patients preoperative oral antibiotics do bowel preparation,other treatment with traditional way. Control lines of traditional intestinal preparation. After observing two groups of patients before surgery,fecal bacteria cue proportion and postoperative complications.Result:The preoperative intestinal flora,coccus and bacillus ratio were normal in both groups. There were some variation after surgery. 5 cases occurred disorder of coccus and bacillus ratio in test group,and 2 cases occurred diarrhea. However,13 cases occurred disorder of coccus and bacillus ratio in test group,and 8 cases occurred diarrhea. The difference was significant (P0.05).Conclusion:Preoperative intestinal preparation need not use oral antibiotic in colorectal cancer.%目的:探讨大肠癌术前口服肠道抗菌素行肠道准备的必要性。方法:选取2011年6月-2012年6月中国医科大学附属第一医院肿瘤外科收治的100例大肠癌患者,采用随机数字表法将其分为试验组和对照组,各50例。试验组术前未口服抗生素行肠道准备,其他治疗同传统方式。对照组术前行传统肠道准备。观察两组患者手术前、后粪便细菌球杆比例及术后并发症。结果:两组患者术前粪便细菌球杆比例均正常,术后大便细菌涂片检查肠道细菌球杆比例均有不同程度变化。试验组患者术后肠道细菌球杆比例失调者5例,程度相对较轻;腹泻2例。对照组术后肠道细菌球杆比例失调者13例,程度相对较重,腹泻8例。试验组术后肠道细菌球杆失调比例明显低于对照

  14. Empty arms : the effect of the arms trade on mothers and children

    OpenAIRE

    Southall, DP; O'Hare, BAM

    2002-01-01

    Trading in arms, both legal and illegal, is highly detrimental to the health of mothers and children in the countries where armed conflict occurs. But do the powerful arms trading countries want to address the problems they are causing?.

  15. 从预防心肌梗死的降压、降脂治疗和英-斯堪的纳维亚心脏病后果研究的临床试验中获得的启示%Perspectives from the antihypertensive and lipid-lowering treatment to prevent heart attack trial-lipid lowering trial and the Anglo-Scandinavian cardiac outcomes trial-lipid lowering arm

    Institute of Scientific and Technical Information of China (English)

    李莹莹; 杨杰孚

    2004-01-01

    综述目的:在确诊为高血压的患者中应用他汀类药物降LDL胆固醇的两项大型临床试验中,比较其试验设计、过程及结果.将这次结果纳入先前进行的关于降低胆固醇的临床试验,并对高血压患者亚组进行分析. 最新发现:预防心肌梗死的降压和降脂治疗临床试验(the AntihypertensiVe andLipid-Lowering Treatment to Prevent Heart Attack Trial,ALLHAT-LLT)中尚未发现引起总死亡率(主要终点),心血管死亡率及心血管事件的发生率明显的下降.该结果与英-斯堪的纳维亚心脏病后果研究的临床试验(theAnglo-Scandinavian Cardiac Outcomes Trial,ASCOT-LLA)的研究结果大相径庭.后者曾因冠心病死亡率及心梗发生率(主要终点)显著下降(36%)而提前终止试验.ASCOT-LLA还表明卒中的发生率明显下降(27%),同时使各种主要的血管事件发生率下降.这两次的试验条件相似,均包括10000人以上确诊为高血压并需药物治疗的患者;二者的治疗均选用单一固定剂量他汀类药物,前者为普伐他汀(40mg/d),后者为阿伐他汀(10mg/d).两次试验的主要差别在于ASCOT-LLA的对照组使用的是安慰剂,双盲设计,而ALLHAT-LLT的对照组则仍为常规治疗.总结:ASCOT-LLA试验结果的确表明在高血压患者中服用降脂药物能使LDL胆固醇明显降低并维持其在较低水平.而ALLHAT-LLT则因为未使用更为有效的药物,对照组中常规应用他汀类药物(剂量逐渐加大),缺乏对比效果而无法获得与ASCOT-LLA相同的结果.

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... treatment, screening, diagnostic, prevention, and supportive care trials. Treatment Trials In treatment trials, researchers may gather information about experimental treatments, ...

  17. Design of Robotic Arm Control System Mimics Human Arm Motion

    Directory of Open Access Journals (Sweden)

    A. Salam Al-Ammri

    2013-01-01

    Full Text Available This paper presents a control system to make the robotic hand mimic human hand motion in real time and offline mode. The human hand tracking system is a wearable sensing arm (potentiometers used to determine the position in space and to sense the grasping task of human hand. The maskable sensing arm was designed with same geometrical arrangement of robotic hand that needs to be controlled. The control software of a robot was implemented using Visual Basic and supported with graphical user interface (GUI. The control algorithm depends on joint to joint mapping method to match between the motions at each joint of portable sensing arm with corresponding joint of a robot in order to make the robot mimic the motion.

  18. Application of the Actor-Critic Architecture to Functional Electrical Stimulation Control of a Human Arm.

    Science.gov (United States)

    Thomas, Philip; Branicky, Michael; van den Bogert, Antonie; Jagodnik, Kathleen

    2009-01-01

    Clinical tests have shown that the dynamics of a human arm, controlled using Functional Electrical Stimulation (FES), can vary significantly between and during trials. In this paper, we study the application of the actor-critic architecture, with neural networks for the both the actor and the critic, as a controller that can adapt to these changing dynamics of a human arm. Development and tests were done in simulation using a planar arm model and Hill-based muscle dynamics. We begin by training it using a Proportional Derivative (PD) controller as a supervisor. We then make clinically relevant changes to the dynamics of the arm and test the actor-critic's ability to adapt without supervision in a reasonable number of episodes. Finally, we devise methods for achieving both rapid learning and long-term stability. PMID:20689654

  19. Creating a Reinforcement Learning Controller for Functional Electrical Stimulation of a Human Arm.

    Science.gov (United States)

    Thomas, Philip S; Branicky, Michael; van den Bogert, Antonie; Jagodnik, Kathleen

    2008-01-01

    Clinical tests have shown that the dynamics of a human arm, controlled using Functional Electrical Stimulation (FES), can vary significantly between and during trials. In this paper, we study the application of Reinforcement Learning to create a controller that can adapt to these changing dynamics of a human arm. Development and tests were done in simulation using a two-dimensional arm model and Hill-based muscle dynamics. An actor-critic architecture is used with artificial neural networks for both the actor and the critic. We begin by training it using a Proportional Derivative (PD) controller as a supervisor. We then make clinically relevant changes to the dynamics of the arm and test the actor-critic's ability to adapt without supervision in a reasonable number of episodes. PMID:22081795

  20. The effect of yoga on women with secondary arm lymphoedema from breast cancer treatment

    Directory of Open Access Journals (Sweden)

    Loudon Annette

    2012-05-01

    Full Text Available Abstract Background Women who develop secondary arm lymphoedema subsequent to treatment associated with breast cancer require life-long management for a range of symptoms including arm swelling, heaviness, tightness in the arm and sometimes the chest, upper body impairment and changes to a range of parameters relating to quality of life. While exercise under controlled conditions has had positive outcomes, the impact of yoga has not been investigated. The aim of this study is to determine the effectiveness of yoga in the physical and psycho-social domains, in the hope that women can be offered another safe, holistic modality to help control many, if not all, of the effects of secondary arm lymphoedema. Methods and design A randomised controlled pilot trial will be conducted in Hobart and Launceston with a total of 40 women receiving either yoga intervention or current best practice care. Intervention will consist of eight weeks of a weekly teacher-led yoga class with a home-based daily yoga practice delivered by DVD. Primary outcome measures will be the effects of yoga on lymphoedema and its associated symptoms and quality of life. Secondary outcome measures will be range of motion of the arm and thoracic spine, shoulder strength, and weekly and daily physical activity. Primary and secondary outcomes will be measured at baseline, weeks four, eight and a four week follow up at week twelve. Range of motion of the spine, in a self-nominated group, will be measured at baseline, weeks eight and twelve. A further outcome will be the women’s perceptions of the yoga collected by interview at week eight. Discussion The results of this trial will provide information on the safety and effectiveness of yoga for women with secondary arm lymphoedema from breast cancer treatment. It will also inform methodology for future, larger trials. Trial registration ACTRN12611000202965

  1. NASA's Asteroid Redirect Mission (ARM)

    Science.gov (United States)

    Abell, Paul; Mazanek, Dan; Reeves, David; Naasz, Bo; Cichy, Benjamin

    2015-11-01

    The National Aeronautics and Space Administration (NASA) is developing a robotic mission to visit a large near-Earth asteroid (NEA), collect a multi-ton boulder from its surface, and redirect it into a stable orbit around the Moon. Once returned to cislunar space in the mid-2020s, astronauts will explore the boulder and return to Earth with samples. This Asteroid Redirect Mission (ARM) is part of NASA’s plan to advance the technologies, capabilities, and spaceflight experience needed for a human mission to the Martian system in the 2030s. Subsequent human and robotic missions to the asteroidal material would also be facilitated by its return to cislunar space. Although ARM is primarily a capability demonstration mission (i.e., technologies and associated operations), there exist significant opportunities to advance our knowledge of small bodies in the synergistic areas of science, planetary defense, asteroidal resources and in-situ resource utilization (ISRU), and capability and technology demonstrations. In order to maximize the knowledge return from the mission, NASA is organizing an ARM Investigation Team, which is being preceded by the Formulation Assessment and Support Team. These teams will be comprised of scientists, technologists, and other qualified and interested individuals to help plan the implementation and execution of ARM. An overview of robotic and crewed segments of ARM, including the mission requirements, NEA targets, and mission operations, will be provided along with a discussion of the potential opportunities associated with the mission.

  2. Protocol for the CONVERT trial—Concurrent ONce-daily VErsus twice-daily RadioTherapy: an international 2-arm randomised controlled trial of concurrent chemoradiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage small cell lung cancer (LS-SCLC) and good performance status

    OpenAIRE

    Faivre-Finn, Corinne; Falk, Sally; Ashcroft, Linda; Bewley, Michelle; Lorigan, Paul; Wilson, Elena; Groom, Nicki; Snee, Michael; Fournel, Pierre; Cardenal, Felipe; Bezjak, Andrea; Blackhall, Fiona

    2016-01-01

    Introduction Concurrent ONce-daily VErsus twice-daily RadioTherapy (CONVERT) is the only multicentre, international, randomised, phase III trial open in Europe and Canada looking at optimisation of chemoradiotherapy (RT) in limited stage small cell lung cancer (LS-SCLC). Following on from the Turrisi trial of once-daily versus twice-daily (BD) concurrent chemoradiotherapy, there is a real need for a new phase III trial using modern conformal RT techniques and investigating higher once-daily r...

  3. Reporting of sample size calculation in randomised controlled trials: review

    OpenAIRE

    Charles, Pierre; Giraudeau, Bruno; Dechartres, Agnes; Baron, Gabriel; Ravaud, Philippe

    2009-01-01

    Objectives To assess quality of reporting of sample size calculation, ascertain accuracy of calculations, and determine the relevance of assumptions made when calculating sample size in randomised controlled trials. Design Review. Data sources We searched MEDLINE for all primary reports of two arm parallel group randomised controlled trials of superiority with a single primary outcome published in six high impact factor general medical journals between 1 January 2005 and 31 December 2006. All...

  4. The Pap smear screening as an occasion for smoking cessation and physical activity counselling: effectiveness of the SPRINT randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gorini Giuseppe

    2012-09-01

    Full Text Available Abstract Background The organized Cervical Cancer Screening Programme (CCSP in Italy might represent an occasion to deliver smoking cessation (SC counselling to women attending the Pap test examination. Evidence of effectiveness of physical activity (PA promotion and intervention in adjunct to SC counselling is not strong. Objective of the SPRINT trial was to evaluate the effectiveness of a standard SC counselling intervention delivered by trained midwives in the CCSP, and whether the adjunct of a PA counselling to the SC counselling might increase quit rates. Methods/Design We undertook a randomized controlled trial of 1,100 women undergoing the Pap examination in the three study centres Florence, Turin, and Mantua: 363 were randomly assigned to the SC counselling arm, 366 to the SC + PA counselling arm, and 371 to the control group. The intervention was a standard brief SC counselling combined with a brief counselling on increasing PA, and was tailored according to the Di Clemente-Prochaska motivational stages of change for SC and/or PA. Primary outcomes were quit rates, improvement in the motivational stages of change for SC, and reduced daily cigarette consumption. Analysis was by intention to treat. Results Participants randomized in both intervention arms and in the preparation stage of change for SC doubled their likelihood of quitting at 6-month follow-up in comparison to controls (odds ratio [OR]=2.1, 95% confidence interval [95% CI]:1.0-4.6. Moreover, participants in the intervention arms and in the contemplation stage were more likely to reduce their daily cigarette consumption after the intervention (OR=1.8, 95% CI:1.1-3.0. Our study did not show any effect of PA counselling on various outcomes. Conclusions Smoking cessation counselling delivered by midwives to smokers in preparation and contemplation stages of change during the Pap-smear screening was effective and should be recommended, given the high number of women attending

  5. Scanning ARM Cloud Radar Handbook

    Energy Technology Data Exchange (ETDEWEB)

    Widener, K; Bharadwaj, N; Johnson, K

    2012-06-18

    The scanning ARM cloud radar (SACR) is a polarimetric Doppler radar consisting of three different radar designs based on operating frequency. These are designated as follows: (1) X-band SACR (X-SACR); (2) Ka-band SACR (Ka-SACR); and (3) W-band SACR (W-SACR). There are two SACRs on a single pedestal at each site where SACRs are deployed. The selection of the operating frequencies at each deployed site is predominantly determined by atmospheric attenuation at the site. Because RF attenuation increases with atmospheric water vapor content, ARM's Tropical Western Pacific (TWP) sites use the X-/Ka-band frequency pair. The Southern Great Plains (SGP) and North Slope of Alaska (NSA) sites field the Ka-/W-band frequency pair. One ARM Mobile Facility (AMF1) has a Ka/W-SACR and the other (AMF2) has a X/Ka-SACR.

  6. 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)

    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

  7. Nuclear arms: ethics, strategy, politics

    Energy Technology Data Exchange (ETDEWEB)

    Woolsey, R.J. (ed.)

    1984-01-01

    The range of debate over strategy and arms control today is broader than it was in the late 1950s and early 1960s. In part this is because the early 1980s debate has involved questioning of the fundamental notion of deterrence - by no less than the American Catholic bishops. Today's debate has also seen a national nuclear freeze campaign that, although its congressional supporters have held firmly to a bilateral approach, was tilted perceptibly towards unilateralism by noncongressional leaders at their national conference in February 1983. In one way or another the authors wrestle with different aspects of one central question: could the beginning steps for any consensus be possible, in today's climate, on strategic issues. Ethical issues are addressed in the first 3 papers: Charles Krauthammer, On Nuclear Morality; Patrick Glynn, The Moral Case for the Arms Buildup; and Michael Quinlarc, Thinking Deterrence Through. Three chapters on strategic considerations include: Brent Snowcroft, Understanding the US Strategic Arsenal; William J. Perry, Technological Prospects for US Strategic Forces; and Richard Burt, The Strategic and Political Lessons of INF. Arms control and politics is treated in chapters by: Walter B. Slocombe, Arms Control: Prospects; and Colin S. Gray, Arms Control: Problems. The nonnuclear dimensions of strategy are discussed in chapters by Amory B. and L. Hunter Lovins, Reducing Vulnerability - The Energy Jugular; and Robert Kupperman, Vulnerable America. The chapters on space and defense are: Hans Mark, Arms Control and Space Technology; and Newt Gingrich and John Madison, Space and National Defense. The concluding chapters are by Sen. Sam Nunn, The Need to Reshape Military Stategy; and the editor, R. James Woolsey, The Politics of Vulnerability, 1980-1983.

  8. Participating in Clinical Trials

    Medline Plus

    Full Text Available Home > Health topics A-Z > Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks ... centers across the country. The National Institutes of Health funds much of this basic research. Screening Trials ...

  9. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Usually, trial participants must show signs of the disease or condition before they can join this type of trial. Prevention Trials Click for more information In prevention trials, ...

  10. Usual Care as the Control Group in Clinical Trials of Nonpharmacologic Interventions

    OpenAIRE

    Thompson, B Taylor; Schoenfeld, David

    2007-01-01

    We discuss the pros and cons of including usual care as a control arm in clinical trials of nonpharmacologic interventions. Usual care is a term used to describe the full spectrum of patient care practices in which clinicians have the opportunity (which is not necessarily seized) to individualize care. The decision to use usual care as the control arm should be based on the nature of the research question and the uniformity of usual-care practices. The use of a usual-care arm in a two-arm tri...

  11. The metabolic cost of two ranges of arm position height with and without hand weights during low impact aerobic dance.

    Science.gov (United States)

    Carroll, M W; Otto, R M; Wygand, J

    1991-12-01

    To determine the energy cost of low impact aerobic dance while varying arm movement height and the use of hand weights, 10 adults volunteered to participate in four choreographed trials. All trials consisted of identical leg movements. Arm movements, however, were performed above shoulder level both with and without 0.9-kg hand weights and below shoulder level both with and without 0.9-kg hand weights. Open circuit spirometry was employed throughout the 10-min videotape guided trials, and heart rate was measured by telemetry. Neither the use of hand weights nor the change in arm position height significantly altered the energy cost of low impact aerobic dance. However, heart rate responses were significantly different. Caution should be observed by aerobics instructors and participants as to the use of heart rate as an indicator of intensity for low impact aerobic dance. PMID:1780565

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

    OpenAIRE

    Helliwell Philip S; Turner Deborah E; Woodburn James

    2007-01-01

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

  13. Sequential control signals determine arm and trunk contributions to hand transport during reaching in humans.

    Science.gov (United States)

    Rossi, Elena; Mitnitski, Arnold; Feldman, Anatol G

    2002-01-15

    When reaching towards objects placed outside the arm workspace, the trunk assumes an active role in transport of the hand by contributing to the extent of movement while simultaneously maintaining the direction of reach. We investigated the spatial-temporal aspects of the integration of the trunk motion into reaching. Specifically, we tested the hypothesis that the efficiency ('gain') of the arm-trunk co-ordination determining the contribution of the trunk to the extent of hand movement may vary substantially with the phase of reaching. Sitting subjects made fast pointing movements towards ipsi- and a contralateral targets placed beyond the reach of the right arm so that a forward trunk motion was required to assist in transporting the hand to the target. Sight of the arm and target was blocked before the movement onset. In randomly selected trials, the trunk motion was unexpectedly prevented by an electromagnet. Subjects were instructed to make stereotypical movements whether or not the trunk was arrested. In non-perturbed trials, most subjects began to move the hand and trunk simultaneously. In trunk-blocked trials, it was impossible for the hand to cover the whole pointing distance but the hand trajectory and velocity profile initially matched those from the trials in which the trunk motion was free, approximately until the hand reached its peak velocity. The arm inter-joint co-ordination substantially changed in response to the trunk arrest at a minimal latency of 40 ms after the perturbation onset. The results suggest that when the trunk was free, the influence of the trunk motion on the hand trajectory and velocity profile was initially neutralized by appropriate changes in the arm joint angles. Only after the hand had reached its peak velocity did the trunk contribute to the extent of pointing. Previous studies suggested that the central commands underlying the transport component of arm movements are completed when the hand reaches peak velocity. These

  14. Supporting the President's Arms Control and Nonproliferation Agenda: Transparency and Verification for Nuclear Arms Reductions

    Energy Technology Data Exchange (ETDEWEB)

    Doyle, James E [Los Alamos National Laboratory; Meek, Elizabeth [Los Alamos National Laboratory

    2009-01-01

    The President's arms control and nonproliferation agenda is still evolving and the details of initiatives supporting it remain undefined. This means that DOE, NNSA, NA-20, NA-24 and the national laboratories can help define the agenda, and the policies and the initiatives to support it. This will require effective internal and interagency coordination. The arms control and nonproliferation agenda is broad and includes the path-breaking goal of creating conditions for the elimination of nuclear weapons. Responsibility for various elements of the agenda will be widely scattered across the interagency. Therefore an interagency mapping exercise should be performed to identify the key points of engagement within NNSA and other agencies for creating effective policy coordination mechanisms. These can include informal networks, working groups, coordinating committees, interagency task forces, etc. It will be important for NA-20 and NA-24 to get a seat at the table and a functional role in many of these coordinating bodies. The arms control and nonproliferation agenda comprises both mature and developing policy initiatives. The more mature elements such as CTBT ratification and a follow-on strategic nuclear arms treaty with Russia have defined milestones. However, recent press reports indicate that even the START follow-on strategic arms pact that is planned to be complete by the end of 2009 may take significantly longer and be more expansive in scope. The Russians called for proposals to count non-deployed as well as deployed warheads. Other elements of the agenda such as FMCT, future bilateral nuclear arms reductions following a START follow-on treaty, nuclear posture changes, preparations for an international nuclear security summit, strengthened international safeguards and multilateral verification are in much earlier stages of development. For this reason any survey of arms control capabilities within the USG should be structured to address potential needs

  15. Nuclear physicist, arms control advocate

    CERN Multimedia

    Chang, K

    2002-01-01

    Victor F. Weisskopf, a nuclear physicist who worked on the Manhattan Project to build the first atomic bomb in World War II and later became an ardent advocate of arms control, died Monday at his home in Newton, MA, USA. He was 93 (1 page).

  16. Rhetorical Histories and Arms Negotiations.

    Science.gov (United States)

    Kane, Thomas

    1988-01-01

    Argues that the use of historical events as rhetorical artifacts has sustained cold war assumptions and attitudes; that rhetorical events provide composites for rhetorical histories which become the basis for argumentative appeals; and that these rhetorical histories continue to permeate American diplomacy in general and arms negotiations in…

  17. Formative research in clinical trial development: attitudes of patients with arthritis in enhancing prevention trials

    OpenAIRE

    Taylor, Holly A.; Sugarman, Jeremy; Pisetsky, David S; Bathon, Joan

    2007-01-01

    In preparation for randomised controlled trials (RCTs) of disease‐modifying antirheumatic drugs in patients with early inflammatory arthritis (EIA), formative research was conducted to enhance the design of such trials. The objectives of this research were to (1) determine patients' educational needs as they relate to the necessary elements of informed consent; and (2) assess patients' interest in enrolling in a hypothetical prevention trial. In‐depth interviews were conducted with nine patie...

  18. 33 CFR 154.510 - Loading arms.

    Science.gov (United States)

    2010-07-01

    ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Loading arms. 154.510 Section 154... FACILITIES TRANSFERRING OIL OR HAZARDOUS MATERIAL IN BULK Equipment Requirements § 154.510 Loading arms. (a) Each mechanical loading arm used for transferring oil or hazardous material and placed into...

  19. 32 CFR 935.134 - Arm signals.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Arm signals. 935.134 Section 935.134 National... WAKE ISLAND CODE Motor Vehicle Code § 935.134 Arm signals. (a) Any person operating a motor vehicle and... signal for a turn or stop is made by fully extending the left arm as follows: (1) Left turn—extend...

  20. Estimation of Human Arm Joints Using Two Wireless Sensors in Robotic Rehabilitation Tasks

    Directory of Open Access Journals (Sweden)

    Arturo Bertomeu-Motos

    2015-12-01

    Full Text Available This paper presents a novel kinematic reconstruction of the human arm chain with five degrees of freedom and the estimation of the shoulder location during rehabilitation therapy assisted by end-effector robotic devices. This algorithm is based on the pseudoinverse of the Jacobian through the acceleration of the upper arm, measured using an accelerometer, and the orientation of the shoulder, estimated with a magnetic angular rate and gravity (MARG device. The results show a high accuracy in terms of arm joints and shoulder movement with respect to the real arm measured through an optoelectronic system. Furthermore, the range of motion (ROM of 50 healthy subjects is studied from two different trials, one trying to avoid shoulder movements and the second one forcing them. Moreover, the shoulder movement in the second trial is also estimated accurately. Besides the fact that the posture of the patient can be corrected during the exercise, the therapist could use the presented algorithm as an objective assessment tool. In conclusion, the joints’ estimation enables a better adjustment of the therapy, taking into account the needs of the patient, and consequently, the arm motion improves faster.

  1. Effects of patient safety culture interventions on incident reporting in general practice : A cluster randomised trial a cluster randomised trial

    NARCIS (Netherlands)

    Verbakel, Natasha J.; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

    2015-01-01

    Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial

  2. Performance of arm locking in LISA

    Science.gov (United States)

    McKenzie, Kirk; Spero, Robert E.; Shaddock, Daniel A.

    2009-11-01

    For the Laser Interferometer Space Antenna (LISA) to reach its design sensitivity, the coupling of the free-running laser frequency noise to the signal readout must be reduced by more than 14 orders of magnitude. One technique employed to reduce the laser frequency noise will be arm locking, where the laser frequency is locked to the LISA arm length. In this paper we detail an implementation of arm locking. We investigate orbital effects (changing arm lengths and Doppler frequencies), the impact of errors in the Doppler knowledge that can cause pulling of the laser frequency, and the noise limit of arm locking. Laser frequency pulling is examined in two regimes: at lock acquisition and in steady state. The noise performance of arm locking is calculated with the inclusion of the dominant expected noise sources: ultrastable oscillator (clock) noise, spacecraft motion, and shot noise. We find that clock noise and spacecraft motion limit the performance of dual arm locking in the LISA science band. Studying these issues reveals that although dual arm locking [A. Sutton and D. A. Shaddock, Phys. Rev. DPRVDAQ1550-7998 78, 082001 (2008)10.1103/PhysRevD.78.082001] has advantages over single (or common) arm locking in terms of allowing high gain, it has disadvantages in both laser frequency pulling and noise performance. We address this by proposing a modification to the dual arm-locking sensor, a hybrid of common and dual arm-locking sensors. This modified dual arm-locking sensor has the laser frequency pulling characteristics and low-frequency noise coupling of common arm locking, but retains the control system advantages of dual arm locking. We present a detailed design of an arm-locking controller and perform an analysis of the expected performance when used with and without laser prestabilization. We observe that the sensor phase changes beneficially near unity-gain frequencies of the arm-locking controller, allowing a factor of 10 more gain than previously believed

  3. Effects of Green Tea Extract on Insulin Resistance and Glucagon-Like Peptide 1 in Patients with Type 2 Diabetes and Lipid Abnormalities: A Randomized, Double-Blinded, and Placebo-Controlled Trial

    OpenAIRE

    Chia-Yu Liu; Chien-Jung Huang; Lin-Huang Huang; I-Ju Chen; Jung-Peng Chiu; Chung-Hua Hsu

    2014-01-01

    The aim of this study is to investigate the effect of green tea extract on patients with type 2 diabetes mellitus and lipid abnormalities on glycemic and lipid profiles, and hormone peptides by a double-blinded, randomized and placebo-controlled clinical trial. This trial enrolled 92 subjects with type 2 diabetes mellitus and lipid abnormalities randomized into 2 arms, each arm comprising 46 participants. Of the participants, 39 in therapeutic arm took 500 mg green tea extract, three times a ...

  4. Microbicide clinical trial adherence: insights for introduction.

    Science.gov (United States)

    Woodsong, Cynthia; MacQueen, Kathleen; Amico, K Rivet; Friedland, Barbara; Gafos, Mitzy; Mansoor, Leila; Tolley, Elizabether; McCormack, Sheena

    2013-01-01

    After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs. PMID:23561044

  5. Microbicide clinical trial adherence: insights for introduction

    Directory of Open Access Journals (Sweden)

    Cynthia Woodsong

    2013-04-01

    Full Text Available After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1 Adherence measurement in clinical trials, (2 Comprehension of use instructions/Instructions for use, (3 Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4 Partner influence on use, (5 Retention and continuation and (6 Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.

  6. How Do Clinical Trials Work?

    Science.gov (United States)

    ... Trials Clinical Trial Websites How Do Clinical Trials Work? If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  7. Telescopic arm with automatic advance

    International Nuclear Information System (INIS)

    By means of the telescopic arm TV cameras, tools or the like can be moved in and out of reactor pressure vessels. For pressure and traction driving element a curved steel band is used which is guided in the central axis of the telescopic arm by means of one adapting element each per telescopic member. On advancing the steel band, which can absorb considerable bending moments, is drawn out of a cartridge with a spool, by meanes of friction rollers. A nozzle-shaped device in front of the cartridge is flattering the steel band before winding it up. The free buckling length of the stell band is never greater than the distance between two adapting elements (part in the shape of a parallelpiped with a slot for guiding the steel band) resp. the length of a telescopic member. (UWI)

  8. 6. La critique des armes

    OpenAIRE

    Sommier, Isabelle

    2015-01-01

    Alors que les groupes d’extrême gauche se sont structurés au sortir des événements de 68 à partir de l’idée marxiste selon laquelle « l’arme de la critique ne saurait remplacer la critique des armes », ils se délitent au terme d’un processus inverse de mise en examen qui finit en acte d’accusation de l’usage politique de la violence en démocratie. Comment, pour reprendre la dichotomie léniniste, ce qui était hier considéré comme une « guerre juste » s’est-il transmué en une « guerre injuste »...

  9. Dual arm master controller concept

    International Nuclear Information System (INIS)

    The Advanced Servomanipulator (ASM) slave was designed with an anthropomorphic stance, gear/torque tube power drives, and modular construction. These features resulted in increased inertia, friction, and backlash relative to tape-driven manipulators. Studies were performed which addressed the human factors design and performance trade-offs associated with the corresponding master controller best suited for the ASM. The results of these studies, as well as the conceptual design of the dual arm master controller, are presented

  10. Dual arm master controller concept

    International Nuclear Information System (INIS)

    The Advanced Servomanipulator (ASM) slave was designed with an anthropomorphic stance, gear/torque tube power drives, and modular construction. These features resulted in increased inertia, friction, and backlash relative to tape-driven manipulators. Studies were performed which addressed the human factors design and performance trade-offs associated with the corresponding master controller best suited for the ASM. The results of these studies, as well as the conceptual design of the dual arm master controller, are presented. 6 references, 3 figures

  11. Hand-arm vibration syndrome.

    Science.gov (United States)

    Pelmear, P L; Taylor, W

    1994-02-01

    The hand-arm vibration syndrome affects workers who perform tasks that generate vibration. Raynaud's phenomenon and sensory impairment of the fingers are the predominant effects. A history of hand-arm vibration (HAV) exposure in a patient with these symptoms should alert the physician to the diagnosis. Referral to a special clinic or hospital department for multiple clinical tests is required to confirm the diagnosis and, using the Stockholm classification, to grade the severity in each hand. The assessment permits the patient to be monitored either for progression of or recovery from the syndrome. Avoidance of further vibration exposure is recommended, together with the prescription of a slow-release calcium channel blocker to improve peripheral circulation. Hand-arm vibration syndrome should be distinguished from carpal tunnel syndrome (CTS), which may have similar symptomatology but requires different treatments. Surgery is contraindicated in the former and should be the last resort for carpal tunnel syndrome in a worker requiring good grip-strength in future employment. PMID:8185734

  12. Photoelectric radar servo control system based on ARM+FPGA

    Science.gov (United States)

    Wu, Kaixuan; Zhang, Yue; Li, Yeqiu; Dai, Qin; Yao, Jun

    2016-01-01

    In order to get smaller, faster, and more responsive requirements of the photoelectric radar servo control system. We propose a set of core ARM + FPGA architecture servo controller. Parallel processing capability of FPGA to be used for the encoder feedback data, PWM carrier modulation, A, B code decoding processing and so on; Utilizing the advantage of imaging design in ARM Embedded systems achieves high-speed implementation of the PID algorithm. After the actual experiment, the closed-loop speed of response of the system cycles up to 2000 times/s, in the case of excellent precision turntable shaft, using a PID algorithm to achieve the servo position control with the accuracy of + -1 encoder input code. Firstly, This article carry on in-depth study of the embedded servo control system hardware to determine the ARM and FPGA chip as the main chip with systems based on a pre-measured target required to achieve performance requirements, this article based on ARM chip used Samsung S3C2440 chip of ARM7 architecture , the FPGA chip is chosen xilinx's XC3S400 . ARM and FPGA communicate by using SPI bus, the advantage of using SPI bus is saving a lot of pins for easy system upgrades required thereafter. The system gets the speed datas through the photoelectric-encoder that transports the datas to the FPGA, Then the system transmits the datas through the FPGA to ARM, transforms speed datas into the corresponding position and velocity data in a timely manner, prepares the corresponding PWM wave to control motor rotation by making comparison between the position data and the velocity data setted in advance . According to the system requirements to draw the schematics of the photoelectric radar servo control system and PCB board to produce specially. Secondly, using PID algorithm to control the servo system, the datas of speed obtained from photoelectric-encoder is calculated position data and speed data via high-speed digital PID algorithm and coordinate models. Finally, a

  13. Massage or music for pain relief in labour: a pilot randomised placebo controlled trial.

    Science.gov (United States)

    Kimber, L; McNabb, M; Mc Court, C; Haines, A; Brocklehurst, P

    2008-11-01

    Research on massage therapy for maternal pain and anxiety in labour is currently limited to four small trials. Each used different massage techniques, at different frequencies and durations, and relaxation techniques were included in three trials. Given the need to investigate massage interventions that complement maternal neurophysiological adaptations to labour and birth pain(s), we designed a pilot randomised controlled trial (RCT) to test the effects of a massage programme practised during physiological changes in pain threshold, from late pregnancy to birth, on women's reported pain, measured by a visual analogue scale (VAS) at 90 min following birth. To control for the potential bias of the possible effects of support offered within preparation for the intervention group, the study included 3 arms--intervention (massage programme with relaxation techniques), placebo (music with relaxation techniques) and control (usual care). The placebo offered a non-pharmacological coping strategy, to ensure that use of massage was the only difference between intervention and placebo groups. There was a trend towards slightly lower mean pain scores in the intervention group but these differences were not statistically significant. No differences were found in use of pharmacological analgesia, need for augmentation or mode of delivery. There was a trend towards more positive views of labour preparedness and sense of control in the intervention and placebo groups, compared with the control group. These findings suggest that regular massage with relaxation techniques from late pregnancy to birth is an acceptable coping strategy that merits a large trial with sufficient power to detect differences in reported pain as a primary outcome measure. PMID:18304848

  14. Single trial prediction of self-paced reaching directions from EEG signals

    Directory of Open Access Journals (Sweden)

    Eileen Yi Lee Lew

    2014-08-01

    Full Text Available Early detection of movement intention could possibly minimize the delays in the activation of neuroprosthetic devices. As yet, single trial analysis using non-invasive approaches for understanding such movement preparation remains a challenging task. We studied the feasibility of predicting movement directions in self-paced upper limb center-out reaching tasks, i.e., spontaneous movements executed without an external cue that can better reflect natural motor behavior in humans. We reported results of non-invasive electroencephalography (EEG recorded from mild stroke patients and able-bodied participants. Previous studies have shown that low frequency EEG oscillations are modulated by the intent to move and therefore, can be decoded prior to the movement execution. Motivated by these results, we investigated whether slow cortical potentials (SCPs preceding movement onset can be used to classify reaching directions and evaluated the performance using 5-fold cross-validation. For able-bodied subjects, we obtained an average decoding accuracy of 76% (chance level of 25% at 62.5ms before onset using the amplitude of on-going SCPs with above chance level performances between 875ms to 437.5ms prior to onset. The decoding accuracy for the stroke patients was on average 47% with their paretic arms. Comparison of the decoding accuracy across different frequency ranges (i.e., SCPs, delta, theta, alpha and gamma yielded the best accuracy using SCPs filtered between 0.1 to 1 Hz. Across all the subjects, including stroke subjects, the best selected features were obtained mostly from the fronto-parietal regions, hence consistent with previous neurophysiological studies on arm reaching tasks. In summary, we concluded that SCPs allow the possibility of single trial decoding of reaching directions at least 312.5ms before onset of reach.

  15. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study ... lifestyle changes, such as exercising more, getting more sleep, keeping mentally active, or eating nutritious foods, can ...

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks and Benefits Terms ... with Your Doctor Taking Medicines The information in this topic was provided by the National Library of ...

  17. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... that could identify a disease in its early stages. Usually, trial participants must show signs of the ... Trials Clinical trials of drugs are usually described based on their phase. The U.S. Food and Drug ...

  18. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... trial is to find out if an experimental drug, therapy, medical device, lifestyle change, or test will ... disease. Phases of Clinical Trials Clinical trials of drugs are usually described based on their phase. The ...

  19. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study that involves human subjects. The purpose of ...

  20. Towards sustainable clinical trials

    OpenAIRE

    Group, Sustainable Trials Study

    2007-01-01

    Currently, few researchers think about the carbon footprint of their trial. The Sustainable Trials Study Group reports that clinical trials are carbon intensive and suggests ways to make them more efficient

  1. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study that involves human subjects. The purpose ...

  2. The Impact of War on Children: A Review of Progress Since the 1996 United Nations Report on the Impact of Armed Conflict on Children.

    Science.gov (United States)

    Machel, Graca

    The outgrowth of a 1996 report on the impact of armed conflict on the well-being of children, and preparation for the 2000 International Conference on War-affected Children, this book examines progress made and obstacles encountered since 1996 in relieving the trauma of armed conflict. The stories recount family displacement, the rise of HIV/AIDS…

  3. Clinical trials of conformal therapy - physics aspects

    International Nuclear Information System (INIS)

    If Conformal Therapy (CFRT) hadn't existed, physicists would have invented it! So many of the concepts involved are physicist ones: 3-D dose calculation/planning, Beam's-Eye-View, Dose-Volume Histograms, Multileaf Collimators, Computer-Controlled Delivery, Megavoltage Imaging, Optimization, Inverse Planning, Tomotherapy, Biological Modeling, even Protons. All the above developments, many of them involving fairly expensive technology, are on trial. If we wish to be able to use and to continue development of these physicist tools in the future then it has to be demonstrated conclusively that CFRT results in improved clinical outcome. Physicists should therefore be in the front line of planning, executing and evaluating Clinical Trials of Conformal Therapy, by which I mean Randomized, Prospective Phase-III trials i.e. ones that have improved complication-free local control/survival as their endpoint. A prospective, randomized trial to assess the effect of reducing the volume of irradiated normal tissue on acute side-effects in pelvic radiotherapy (93% prostate or bladder ca.) has been carried out at our centre, on 266 patients. In both arms a 3-field, 6 MV x-ray technique was used with identical dose prescriptions; in the conventional arm rectangular fields were employed whereas in the conformal arm the fields were shaped with customized blocks drawn according to the Beam's-Eye-View of the target volume. Substantial differences in normal-tissue volumes (rectum, bladder etc.) were achieved: mean High-Dose Volume (∼ PTV) of 690 cm3 for the conformal technique vs 940 cm3 conventionally. Comprehensive quality-of-life questionnaire were completed before the start of treatment, weekly during and for 3 weeks after the end of treatment and then monthly for a further 2 months. A clear pattern of an increase during followed by a decrease after treatment in symptoms relating to bowel and bladder functions was observed for the patient group as a whole. However, a very extensive

  4. The Asteroid Redirect Mission (ARM)

    Science.gov (United States)

    Abell, Paul; Gates, Michele; Johnson, Lindley; Chodas, Paul; Mazanek, Dan; Reeves, David; Ticker, Ronald

    2016-07-01

    To achieve its long-term goal of sending humans to Mars, the National Aeronautics and Space Administration (NASA) plans to proceed in a series of incrementally more complex human spaceflight missions. Today, human flight experience extends only to Low-Earth Orbit (LEO), and should problems arise during a mission, the crew can return to Earth in a matter of minutes to hours. The next logical step for human spaceflight is to gain flight experience in the vicinity of the Moon. These cis-lunar missions provide a "proving ground" for the testing of systems and operations while still accommodating an emergency return path to the Earth that would last only several days. Cis-lunar mission experience will be essential for more ambitious human missions beyond the Earth-Moon system, which will require weeks, months, or even years of transit time. In addition, NASA has been given a Grand Challenge to find all asteroid threats to human populations and know what to do about them. Obtaining knowledge of asteroid physical properties combined with performing technology demonstrations for planetary defense provide much needed information to address the issue of future asteroid impacts on Earth. Hence the combined objectives of human exploration and planetary defense give a rationale for the Asteroid Re-direct Mission (ARM). Mission Description: NASA's ARM consists of two mission segments: 1) the Asteroid Redirect Robotic Mission (ARRM), the first robotic mission to visit a large (greater than ~100 m diameter) near-Earth asteroid (NEA), collect a multi-ton boulder from its surface along with regolith samples, demonstrate a planetary defense technique, and return the asteroidal material to a stable orbit around the Moon; and 2) the Asteroid Redirect Crewed Mission (ARCM), in which astronauts will take the Orion capsule to rendezvous and dock with the robotic vehicle, conduct multiple extravehicular activities to explore the boulder, and return to Earth with samples. NASA's proposed

  5. Preventing Interstate Armed Conflict : whose responsibility?

    OpenAIRE

    Otunba, Ganiyu

    2010-01-01

    This is a study of interstate armed conflict prevention. The concept of conflict, armed conflict and conflict prevention is defined and explained in order to be able to investigate if there is any single institution saddled with the responsibility of preventing interstate armed conflict and also to verify if adequate efforts are been put in this area which is of importance to mankind. The relationship between conflict prevention, conflict management and conflict resolution is also discussed s...

  6. Introduction to Reading and Visualizing ARM Data

    Energy Technology Data Exchange (ETDEWEB)

    Mather, James [Pacific Northwest National Laboratory

    2014-02-18

    Atmospheric Radiation Measurement (ARM) Program standard data format is NetCDF 3 (Network Common Data Form). The object of this tutorial is to provide a basic introduction to NetCDF with an emphasis on aspects of the ARM application of NetCDF. The goal is to provide basic instructions for reading and visualizing ARM NetCDF data with the expectation that these examples can then be applied to more complex applications.

  7. Theory of Robotics Arm Control with PLC

    OpenAIRE

    Safdar, Bilal

    2015-01-01

    This thesis was commissioned for Saimaa University of Applied Sciences with the aim of understanding the control system for a robotic arm. The Robotic Arm in this case was from Saimaa University of Applied Sciences. The main objective of this thesis was to understand a control system for the Robotic Arm using a programmable logic controller (PLC) along with gripper. The control system consisted of the electronic components (the PLC, a motor controller, a voltage regulator, a control pende...

  8. A comprehensive approach to nuclear arms control

    International Nuclear Information System (INIS)

    Cold war nuclear arms control was characterized by American Soviet hostility and the limits of verification; the end of the cold war allowed for a more cooperative approach. From this new situation emerged the idea of a new agenda for arms control and of exploring a more comprehensive approach to nuclear arms control. The author posits eight elements for such a comprehensive approach. Though such an approach seems unrealistic today, recent history teaches us to look beyond today's constraints. (author)

  9. Lever arm dysfunction in cerebral palsy gait

    OpenAIRE

    Theologis, Tim

    2013-01-01

    Skeletal structures act as lever arms during walking. Muscle activity and the ground reaction against gravity exert forces on the skeleton, which generate torque (moments) around joints. These lead to the sequence of movements which form normal human gait. Skeletal deformities in cerebral palsy (CP) affect the function of bones as lever arms and compromise gait. Lever arm dysfunction should be carefully considered when contemplating treatment to improve gait in children with CP.

  10. Dual arm master controller development

    International Nuclear Information System (INIS)

    The advanced servomanipulator (ASM) slave was designed with an anthropomorphic stance, gear/torque tube power drives, and modular construction. These features resulted in increased inertia, friction, and backlash relative to tape-driven manipulators. Studies were performed which addressed the human factors design and performance trade-offs associated with the corresponding master controller best suited for the ASM. The results of these studies, as well as the conceptual design of the dual arm master controller, are presented. This work was performed as part of the Consolidated Fuel Reprocessing Program at the Oak Ridge National Laboratory. 5 refs., 7 figs., 1 tab

  11. The Possible Models of Creative Therapies for the Child Victims of War and Armed Conflicts

    Science.gov (United States)

    Minou, Tabatabai

    2006-01-01

    After war and armed conflicts, the child victims of these events need protection and reintegration. In reality, the physical and psychic consequences of wars on children persist for some time after the war. In this regard, we must prepare the reintegration of these children into society. To reintegrate these children, we must think of both a…

  12. MODELING AND SIMULATION OF ROBOTIC HUMANOID ARM

    Directory of Open Access Journals (Sweden)

    RANJEET RANJAN

    2012-06-01

    Full Text Available In this paper block model and machine model of Robotic humanoid arm has been generated Using MATLAB Simulink. Equations of Kinematics are derived by using D-H notation. By this equation and inverse kinematicsparameters for the motion trajectory have been determined. Kinematic parameters are divided into two groups namely, link parameters and joint parameters. Geometric model and motion of robotic humanoid arm with two link model with 3 Degree of freedom and arm with palm and fingers with 18 degree of freedom has been realized. Virtual simulation of the arm is also first step in actually controlling the mechanical structure.

  13. Changing patterns of US arms transfers

    Energy Technology Data Exchange (ETDEWEB)

    Salomone, M.D.

    1985-01-01

    The thesis has three purposes. First is to explore the changing patterns of US arms transfers from Fiscal Year 1950 (FY 1950) through Fiscal Year 1980 (FY 1980). Second, is to describe and assess the decision-making process for arms transfers within the US Government. Third is to examine and critique the conventional wisdom concerning US arms transfers, to support that wisdom, or to offer an alternate empirically supported view. The conventional wisdom about US arms transfer is that they have been rising at an alarming rate, and that this is the result of an arms transfer decision-making process which is out of control. This belief is founded on an empirically based proposition that arms transfers have been rising at an alarming rate. However, this proposition has never been empirically validated. To explore this conventional wisdom, the author establishes the historical, political and defense policy contexts for US arms transfers over the period FY 1950 through FY 1980. The author critiques the conventional wisdom about US arms transfers, analyzes the many ways that arms transfers have been measured, and explores the impediments to accurate measurement and assessment of the phenomenon.

  14. Short children with a low midupper arm circumference respond to food supplementation

    DEFF Research Database (Denmark)

    Fabiansen, Christian; Phelan, Kevin P Q; Cichon, Bernardette;

    2016-01-01

    BACKGROUND: The management of children with moderate acute malnutrition (MAM) is based on food supplementation in outpatient programs. When midupper arm circumference (MUAC) is used as the sole admission criterion, it is common practice to exclude children with lengths <67 cm from treatment. The ...... children <67 cm in supplementary feeding programs if their MUAC is between 115 and 124 mm and their WHZ is ≥-2. This could benefit millions of children currently excluded from supplementary feeding. This trial was registered at www.controlled-trials.com as ISRCTN42569496....

  15. Retraining of interjoint arm coordination after stroke using robot-assisted time-independent functional training

    Directory of Open Access Journals (Sweden)

    Elizabeth B. Brokaw, MS

    2011-05-01

    Full Text Available We have developed a haptic-based approach for retraining of interjoint coordination following stroke called time-independent functional training (TIFT and implemented this mode in the ARMin III robotic exoskeleton. The ARMin III robot was developed by Drs. Robert Riener and Tobias Nef at the Swiss Federal Institute of Technology Zurich (Eidgenossische Technische Hochschule Zurich, or ETH Zurich, in Zurich, Switzerland. In the TIFT mode, the robot maintains arm movements within the proper kinematic trajectory via haptic walls at each joint. These arm movements focus training of interjoint coordination with highly intuitive real-time feedback of perform-ance; arm movements advance within the trajectory only if their movement coordination is correct. In initial testing, 37 nondisabled subjects received a single session of learning of a complex pattern. Subjects were randomized to TIFT or visual demonstration or moved along with the robot as it moved though the pattern (time-dependent [TD] training. We examined visual demonstration to separate the effects of action observation on motor learning from the effects of the two haptic guidance methods. During these training trials, TIFT subjects reduced error and interaction forces between the robot and arm, while TD subject performance did not change. All groups showed significant learning of the trajectory during unassisted recall trials, but we observed no difference in learning between groups, possibly because this learning task is dominated by vision. Further testing in stroke populations is warranted.

  16. Cortical Spiking Network Interfaced with Virtual Musculoskeletal Arm and Robotic Arm.

    Science.gov (United States)

    Dura-Bernal, Salvador; Zhou, Xianlian; Neymotin, Samuel A; Przekwas, Andrzej; Francis, Joseph T; Lytton, William W

    2015-01-01

    Embedding computational models in the physical world is a critical step towards constraining their behavior and building practical applications. Here we aim to drive a realistic musculoskeletal arm model using a biomimetic cortical spiking model, and make a robot arm reproduce the same trajectories in real time. Our cortical model consisted of a 3-layered cortex, composed of several hundred spiking model-neurons, which display physiologically realistic dynamics. We interconnected the cortical model to a two-joint musculoskeletal model of a human arm, with realistic anatomical and biomechanical properties. The virtual arm received muscle excitations from the neuronal model, and fed back proprioceptive information, forming a closed-loop system. The cortical model was trained using spike timing-dependent reinforcement learning to drive the virtual arm in a 2D reaching task. Limb position was used to simultaneously control a robot arm using an improved network interface. Virtual arm muscle activations responded to motoneuron firing rates, with virtual arm muscles lengths encoded via population coding in the proprioceptive population. After training, the virtual arm performed reaching movements which were smoother and more realistic than those obtained using a simplistic arm model. This system provided access to both spiking network properties and to arm biophysical properties, including muscle forces. The use of a musculoskeletal virtual arm and the improved control system allowed the robot arm to perform movements which were smoother than those reported in our previous paper using a simplistic arm. This work provides a novel approach consisting of bidirectionally connecting a cortical model to a realistic virtual arm, and using the system output to drive a robotic arm in real time. Our techniques are applicable to the future development of brain neuroprosthetic control systems, and may enable enhanced brain-machine interfaces with the possibility for finer control of

  17. Cortical spiking network interfaced with virtual musculoskeletal arm and robotic arm

    Directory of Open Access Journals (Sweden)

    Salvador eDura-Bernal

    2015-11-01

    Full Text Available Embedding computational models in the physical world is a critical step towards constraining their behavior and building practical applications. Here we aim to drive a realistic musculoskeletal arm model using a biomimetic cortical spiking model, and make a robot arm reproduce the same trajectories in real time. Our cortical model consisted of a 3-layered cortex, composed of several hundred spiking model-neurons, which display physiologically realistic dynamics. We interconnected the cortical model to a two-joint musculoskeletal model of a human arm, with realistic anatomical and biomechanical properties. The virtual arm received muscle excitations from the neuronal model, and fed back proprioceptive information, forming a closed-loop system. The cortical model was trained using spike timing-dependent reinforcement learning to drive the virtual arm in a 2D reaching task. Limb position was used to simultaneously control a robot arm using an improved network interface. Virtual arm muscle activations responded to motoneuron firing rates, with virtual arm muscles lengths encoded via population coding in the proprioceptive population. After training, the virtual arm performed reaching movements which were smoother and more realistic than those obtained using a simplistic arm model. This system provided access to both spiking network properties and to arm biophysical properties, including muscle forces. The use of a musculoskeletal virtual arm and the improved control system allowed the robot arm to perform movements which were smoother than those reported in our previous paper using a simplistic arm.This work provides a novel approach consisting of bidirectionally connecting a cortical model to a realistic virtual arm, and using the system output to drive a robotic arm in real time. Our techniques are applicable to the future development of brain neuro-prosthetic control systems, and may enable enhanced brain-machine interfaces with the possibility

  18. The Design of Humanoid Robot Arm Based on Morphological and Neurological Analysis of Human Arm

    OpenAIRE

    Moon, Yongseon; Ko, Nak Yong; Bae, Youngchul

    2009-01-01

    In this paper, we have presented the implementation and performance evaluation for SERCOS based humanoid robot arm by using morphological and neurological analysis of human arm. Moreover, we reviewed the possibility of application of these robot arms. First, we proposed robot development methodology of open architecture based on ISO15745 for "opening of humanoid robot." Then, we verified the method of implementation of humanoid robot arm and its application to the real world. We have implemen...

  19. Soldiers and Marksmen Under Fire: Monitoring Performance with Neural Correlates of Small Arms Fire Localization

    Directory of Open Access Journals (Sweden)

    Jason eSherwin

    2013-03-01

    Full Text Available Important decisions in the heat of battle occur rapidly and a key aptitude of a good combat soldier is the ability to determine whether he is under fire. This rapid decision requires the soldier to make a judgment in a fraction of a second, based on a barrage of multisensory cues coming from the auditory, tactile and visual domains. The present study uses an auditory oddball paradigm to examine listener ability to differentiate shooter locations from audio recordings of small arms fire. More importantly, we address the neural correlates involved in this rapid decision process by employing single-trial analysis of electroencephalography (EEG. In particular, we examine small arms expert listeners as they differentiate the sounds of small arms firing events recorded at different observer positions relative to a shooter. Using signal detection theory, we find clear neural signatures related to shooter firing angle by identifying the times of neural discrimination on a trial-to-trial basis. Similar to previous results in oddball experiments, we find common windows relative to the response and the stimulus when neural activity discriminates between target stimuli (forward fire: observer 0° to firing angle vs. standards (off-axis fire: observer 90° to firing angle. We also find, using windows of maximum discrimination, that auditory target vs. standard discrimination yields neural sources in Brodmann Area 19 (BA 19, i.e., in the visual cortex. In summary, we show that single-trial analysis of EEG yields informative scalp distributions and source current localization of discriminating activity when the small arms experts discriminate between forward and off-axis fire observer positions. Furthermore, this perceptual decision implicates brain regions involved in visual processing, even though the task is purely auditory. Finally, we utilize these techniques to quantify the level of expertise in these subjects for the chosen task, having implications for

  20. 31 CFR 543.301 - Arms or any related materiel.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Arms or any related materiel. 543.301... Definitions § 543.301 Arms or any related materiel. The term arms or any related materiel means arms or... of arms and related materiel and technical training and assistance intended solely for support of...

  1. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical ... to treat or cure a disease. Phases of Clinical Trials Clinical trials of drugs are usually described based ...

  2. Clinical Trials in Vision Research

    Science.gov (United States)

    ... Eye Health Information > Clinical Trials in Vision Research Clinical Trials in Vision Research Listen Clinical studies depend on ... vision research in the United States. Basics of Clinical Trials What is a clinical trial? Clinical trials are ...

  3. Results from a blind and a non-blind randomised trial run in parallel: experience from the Estonian Postmenopausal Hormone Therapy (EPHT Trial

    Directory of Open Access Journals (Sweden)

    Veerus Piret

    2012-04-01

    Full Text Available Abstract Background The Estonian Postmenopausal Hormone Therapy (EPHT Trial assigned 4170 potential participants prior to recruitment to blind or non-blind hormone therapy (HT, with placebo or non-treatment the respective alternatives. Before having to decide on participation, women were told whether they had been randomised to the blind or non-blind trial. Eligible women who were still willing to join the trial were recruited. After recruitment participants in the non-blind trial (N = 1001 received open-label HT or no treatment, participants in the blind trial (N = 777 remained blinded until the end of the trial. The aim of this paper is to analyse the effect of blinding on internal and external validity of trial outcomes. Methods Effect of blinding was calculated as the hazard ratio of selected chronic diseases, total mortality and all outcomes. For analysing the effect of blinding on external validity, the hazard ratios from women recruited to the placebo arm and to the non-treatment arm were compared with those not recruited; for analysing the effect of blinding on internal validity, the hazard ratios from the blind trial were compared with those from the non-blind trial. Results The women recruited to the placebo arm had less cerebrovascular disease events (HR 0.43; 95% CI: 0.26-0.71 and all outcomes combined (HR 0.76; 95% CI: 0.63-0.91 than those who were not recruited. Among women recruited or not recruited to the non-treatment arm, no differences were observed for any of the outcomes studied. Among women recruited to the trial, the risk for coronary heart disease events (HR 0.77; 95% CI: 0.64-0.93, cerebrovascular disease events (HR 0.66; 95%CI: 0.47-0.92, and all outcomes combined (HR 0.82; 95% CI: 0.72-0.94 was smaller among participants in the blind trial than in the non-blind trial. There was no difference between the blind and the non-blind trial for total cancer (HR 0.95; 95% CI: 0.64-1.42, bone fractures (0.93; 95% CI: 0

  4. De-Conflicting Canada’s Anti-Terrorism Legislation: Khawaja and the Ongoing Challenges of the ‘Armed Conflict’ Exclusion

    OpenAIRE

    Christopher K. Penny

    2016-01-01

    The definition of ‘terrorist activity’ is fundamental to Canada’s anti-terrorism legislation. Following the recent trial of Momin Khawaja before the Ontario Superior Court of Justice, it is clear that the ‘armed conflict’ exclusion – exempting wartime activities undertaken in accordance with international law – poses serious challenges to the coherence of this legislative regime, threatening the effectiveness of future domestic terrorism prosecutions. This article examines the ‘armed conflict...

  5. [Multicentre-clinical trial of the novel corticosteroid diflucortolone valerate in the forms of cream, ointment and fatty ointment. Part II: Comparative study with several commercial preparations (author's transl)].

    Science.gov (United States)

    Reckers, V R; Wendt, H

    1976-01-01

    6alpha,9-Difluoro-11beta-hydroxy-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione (diflucortolone valerate, Nerisona) in the forms of cream, ointment and fatty ointment was investigated against 5 commercial preparations with beta-methasone-17-valerate, fluocinonide, fluocinolone acetonide, flumetasone pivalate and desoximetasone in 15 simultaneously conducted and multicentre-clinical studies-all on double-blind contralateral studies-involving a total of 1923 patients. The Nerisona preparations proved to be highly effective-particularly in eczematous diseases- and comparable to the above-mentioned commercial preparations. Nerisona ointment was shown to be superior to flumetasone cream. The statistical reliability of such data is discussed. PMID:795434

  6. Coordinating arms and legs on a hybrid rehabilitation tricycle: the metabolic benefit of asymmetrical compared to symmetrical arm movements

    OpenAIRE

    Meyns, Pieter; Van De Walle, Patricia; Hoogkamer, Wouter; Kiekens, Carlotte; Desloovere, Kaat; Duysens, Jaak

    2014-01-01

    The most commonly used propulsion method for handcycling is moving the arms symmetrically. Previous studies indicated that during outdoor handcycling symmetrical arm movements are more efficient. During locomotor movements, however, arm movements are performed asymmetrically in combination with leg movements. We questioned which combination of arm and leg movements is more efficient during combined arm and leg cycling for stationary use.

  7. Clinical trials of homoeopathy.

    OpenAIRE

    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 MEASURE...

  8. Immobilization of pectinase on silica-based supports: Impacts of particle size and spacer arm on the activity.

    Science.gov (United States)

    Alagöz, Dilek; Tükel, S Seyhan; Yildirim, Deniz

    2016-06-01

    The pectinase was separately immobilized onto Florisil and nano silica supports through both glutaraldehyde and 3-glyoxypropyltrietoxysilane spacer arms. The effects of spacer arm, particle size of support and ionic liquids on the activities of pectinase preparations were investigated. The immobilization of pectinase onto Florisil and nano silica through 3-glyoxypropyltrietoxysilane spacer arm completely led to inactivation of enzyme; however, 10 and 75% pectinase activity were retained when it was immobilized through glutaraldehyde spacer arm onto Florisil and nano silica, respectively. The pectinase immobilized onto nano silica through glutaraldehyde spacer arm showed 6.3-fold higher catalytic efficiency than that of the pectinase immobilized onto Florisil through same spacer arm. A 2.3-fold increase in thermal stability of pectinase was provided upon immobilization onto nano silica at 35°C. The effects of IL/buffer mixture and volume ratio of IL/buffer mixture on the catalytic activities of free and immobilized pectinase preparations were also tested. All the pectinase preparations showed highest activity in 10% (v/v) 1-butyl-3-methylimidazolium hexafluorophosphate containing medium and their activities significantly affected from the concentration of 1-butyl-3-methylimidazolium hexafluorophosphate. PMID:26964525

  9. 78 FR 30731 - Armed Forces Day, 2013

    Science.gov (United States)

    2013-05-22

    ... hundred and thirty- seventh. (Presidential Sig.) [FR Doc. 2013-12402 Filed 5-21-13; 11:15 am] Billing code..., liberty, and the pursuit of happiness. And on Armed Forces Day, we honor those who serve bravely and... the United States at their homes on Armed Forces Day, and I urge citizens to learn more about...

  10. Homosexuality in the Dutch Armed Forces 2006

    NARCIS (Netherlands)

    Anna Adolfsen; Saskia Keuzenkamp; m.m.v. Linda Mans

    2006-01-01

    Original title: Uniform uit de kast. This study looks at the attitudes of defence personnel to homosexuality. How do members of the military view homosexual colleagues? Can gays and lesbians working in the armed forces be open about their sexual preferences? Do they regard the armed forces as a gay

  11. Design of a biomimetic robotic octopus arm

    International Nuclear Information System (INIS)

    This paper reports the rationale and design of a robotic arm, as inspired by an octopus arm. The octopus arm shows peculiar features, such as the ability to bend in all directions, to produce fast elongations, and to vary its stiffness. The octopus achieves these unique motor skills, thanks to its peculiar muscular structure, named muscular hydrostat. Different muscles arranged on orthogonal planes generate an antagonistic action on each other in the muscular hydrostat, which does not change its volume during muscle contractions, and allow bending and elongation of the arm and stiffness variation. By drawing inspiration from natural skills of octopus, and by analysing the geometry and mechanics of the muscular structure of its arm, we propose the design of a robot arm consisting of an artificial muscular hydrostat structure, which is completely soft and compliant, but also able to stiffen. In this paper, we discuss the design criteria of the robotic arm and how this design and the special arrangement of its muscular structure may bring the building of a robotic arm into being, by showing the results obtained by mathematical models and prototypical mock-ups

  12. Small Arms Marksmanship Manual, NAVPERS 93863.

    Science.gov (United States)

    Bureau of Naval Personnel, Washington, DC.

    The Navy's small arms marksmanship training program is designed to achieve proficiency for Navy personnel in handling the rifle, pistol andshotgun. The minimum objective of this program is to qualify Navy personnel as "Marksman," and ensure that personnel who are issued small arms for security, recreation, or competitions are fully qualified in…

  13. Sudarshan Kriya yoga improves quality of life in healthy people living with HIV (PLHIV: results from an open label randomized clinical trial

    Directory of Open Access Journals (Sweden)

    N Mawar

    2015-01-01

    Full Text Available Background & objectives: Improving quality of life (QOL of healthy people living with HIV (PLHIV is critical needing home-based, long-term strategy. Sudarshan Kriya yoga (SKY intervention is acknowledged for its positive impact on health. It is hypothesised that SKY would improve PLHIV′s QOL, justifying an evaluation. Methods: In this open label randomized controlled pilot trial, 61 adult PLHIV with CD4 count more than 400 cells/µl and Karnofsky scale score above 70 were enrolled. Those with cardiac disease, jaundice, tuberculosis, or on antiretroviral therapy/yoga intervention were excluded. All were given standard care, randomized to SKY intervention (31: I-SKY and only standard of care in control (30: O-SOC arms. The I-SKY participants were trained for six days to prepare for daily practice of SKY at home for 30 min. A validated 31-item WHOQOL-HIVBREF questionnaire was used to document effect in both arms from baseline to three visits at 4 wk interval. Results: Baseline QOL scores, hypertension and CD4 count were similar in both arms. An overall 6 per cent improvement of QOL scores was observed in I-SKY group as compared to O-SOC group, after controlling for baseline variables like age, gender, education and occupation ( p0 =0.016; 12 per cent for physical ( p0 =0.004, 11 per cent psychological ( p0 =0.023 and 9 per cent level of independence ( p0 =0.001 domains. Improvement in I-SKY observed at post-training and in the SKY adherence group showed increase in these two domains. Conclusions: A significant improvement in QOL scores was observed for the three health related QOL domains in SKY intervention arm. This low cost strategy improved physical and psychological state of PLHIV calling for upscaling with effective monitoring for sustainability of quality of life.

  14. Arm locking with Doppler estimation errors

    Energy Technology Data Exchange (ETDEWEB)

    Yu Yinan; Wand, Vinzenz; Mitryk, Shawn; Mueller, Guido, E-mail: yinan@phys.ufl.ed [Department of Physics, University of Florida, Gainesville, FL 32611 (United States)

    2010-05-01

    At the University of Florida we developed the University of Florida LISA Interferometer Simulator (UFLIS) in order to study LISA interferometry with hardware in the loop at a system level. One of the proposed laser frequency stabilization techniques in LISA is arm locking. Arm locking uses an adequately filtered linear combination of the LISA arm signals as a frequency reference. We will report about experiments in which we demonstrated arm locking using UFLIS. During these experiments we also discovered a problem associated with the Doppler shift of the return beam. The initial arm locking publications assumed that this Doppler shift can perfectly be subtracted inside the phasemeter or adds an insignificant offset to the sensor signal. However, the remaining Doppler knowledge error will cause a constant change in the laser frequency if unaccounted for. Several ways to circumvent this problem have been identified. We performed detailed simulations and started preliminary experiments to verify the performance of the proposed new controller designs.

  15. Conflits armés et environnement

    OpenAIRE

    Dorsouma, Al–Hamandou; Bouchard, Michel-André

    2013-01-01

    Les conflits armés sont source de catastrophes majeures pour l’environnement. Dans les années 60, la défoliation de la jungle vietnamienne par l’armée américaine a interpellé la conscience collective sur la protection de l’environnement en situation de conflit armé (Pearce, 2000). La guerre du Golfe de 1990-1991, avec l’utilisation des armes à l’uranium appauvri et l’incendie des puits de pétrole a fait de la protection de l’environnement lors des conflits armés une préoccupation internationa...

  16. Evolution of prehension ability in an anthropomorphic neurorobotic arm

    Directory of Open Access Journals (Sweden)

    Gianluca Massera

    2007-11-01

    Full Text Available In this paper, we show how a simulated anthropomorphic robotic arm controlled by an artificial neural network can develop effective reaching and grasping behaviour through a trial and error process in which the free parameters encode the control rules which regulate the fine-grained interaction between the robot and the environment and variations of the free parameters are retained or discarded on the basis of their effects at the level of the global behaviour exhibited by the robot situated in the environment. The obtained results demonstrate how the proposed methodology allows the robot to produce effective behaviours thanks to its ability to exploit the morphological properties of the robot's body (i.e. its anthropomorphic shape, the elastic properties of its muscle-like actuators and the compliance of its actuated joints and the properties which arise from the physical interaction between the robot and the environment mediated by appropriate control rules.

  17. Human arm posture prediction in response to isometric endpoint forces.

    Science.gov (United States)

    Davoudabadi Farahani, Saeed; Andersen, Michael Skipper; de Zee, Mark; Rasmussen, John

    2015-11-26

    The ability to predict the musculoskeletal response to external loads has multiple applications for the design of machines with a human interface and for the prediction of outcomes of musculoskeletal interventions. In this study, we applied an inverse-inverse dynamics technique to investigate its ability to predict arm posture in response to isometric hand forces. For each subject, we made a three-dimensional musculoskeletal model using the AnyBody Modelling System (AMS). Then, we had each subject-specific model hold a weight anteriorly to the right shoulder joint at a distance of half of the arm length. We selected the glenohumeral abduction angle (GHAA) as the only free parameter. Subsequently, we used inverse-inverse dynamics to find the optimal GHAA that minimised a performance criterion with physiological constraints. In this study, we investigated the performance of two different objective functions: summation of squared muscle activity (SSMA) and summation of squared normalised joint torques (SSNJT). To validate the simulation results, arm posture responses to different isometric downward hand forces were measured for six healthy male subjects. Five trials were performed for each loading condition. The results showed that, with an increase in hand load, there was a reduced GHAA in all subjects. Another interesting finding was that self-selected postures for lighter tasks varied more than postures for heavier tasks for all subjects. To understand this, we investigated the curvature of the objective function as a function of the load and observed an increased curvature with increased load. This may explain the reduced intra-subject variations observed for increasing loads. PMID:26482735

  18. Arms Control and Strategic Stability

    Institute of Scientific and Technical Information of China (English)

    Hu; Yumin

    2014-01-01

    This essay intends to offer a comment on concepts, trends and attitudes concerning arms control and strategic stability with reference to the current international security situation. It also offers observations from two different perspectives about strategic stability: one proceeds from the concept of universal security and aims to prevent conflicts and instability from disrupting regional and international security environment on which nation states depend so much for their peaceful development; the other starts from maintaining the global leadership by a super power and aiming to contain any challenge that sways or is likely to sway its dominating status. If China and the United States commit themselves to the undertaking of a new type of major powers relationship that stresses win-win cooperation, they will be able to contribute greatly to a stable international security architecture that is good for world peaceful development.

  19. ICRESH-ARMS 2015 Conference

    CERN Document Server

    Ahmadi, Alireza; Verma, Ajit; Varde, Prabhakar

    2016-01-01

    Containing selected papers from the ICRESH-ARMS 2015 conference in Lulea, Sweden, collected by editors with years of experiences in Reliability and maintenance modeling, risk assessment, and asset management, this work maximizes reader insights into the current trends in Reliability, Availability, Maintainability and Safety (RAMS) and Risk Management. Featuring a comprehensive analysis of the significance of the role of RAMS and Risk Management in the decision making process during the various phases of design, operation, maintenance, asset management and productivity in Industrial domains, these proceedings discuss key issues and challenges in the operation, maintenance and risk management of complex engineering systems and will serve as a valuable resource for those in the field.

  20. Surface Sampler Arm Acquiring Sample

    Science.gov (United States)

    1976-01-01

    Operation of the surface sampler in obtaining Martian soil for Viking 2's molecular analysis experiment last Saturday (September 25) was closely monitored by one of the Lander cameras because of the precision required in trenching the small area--8 by 9 inches-surrounded by rocks. Dubbed 'Bonneville Salt Flats,' the exposure of thin crust appeared unique in contrast with surrounding materials and became a prime target for organic analysis in spite of potential hazards. Large rock in foreground is 8 inches high. At left, the sampler scoop has touched the surface, missing the rock at upper left by a comfortable 6 inches, and the backhoe has penetrated the surface about one-half inch. The scoop was then pulled back to sample the desired point and (second photo) the backhoe furrowed the surface pulling a piece of thin crust toward the spacecraft. The initial touchdown and retraction sequence was used to avoid a collision between a rock in the shadow of the arm and a plate joining the arm and scoop. The rock was cleared by 2 to 3 inches. The third picture was taken 8 minutes after the scoop touched the surface and shows that the collector head has acquired a quantity of soil. With surface sampler withdrawn (right), the foot-long trench is seen between the rocks. The trench is three inches wide and about 1 1/2 to 2 inches deep. The scoop reached to within 3 inches of the rock at far end of trench. Penetration appears to have left a cavernous opening roofed by the crust and only about one inch of undisturbed crust separates the deformed surface and the rock.

  1. GMCSF-armed vaccinia virus induces an antitumor immune response.

    Science.gov (United States)

    Parviainen, Suvi; Ahonen, Marko; Diaconu, Iulia; Kipar, Anja; Siurala, Mikko; Vähä-Koskela, Markus; Kanerva, Anna; Cerullo, Vincenzo; Hemminki, Akseli

    2015-03-01

    Oncolytic Western Reserve strain vaccinia virus selective for epidermal growth factor receptor pathway mutations and tumor-associated hypermetabolism was armed with human granulocyte-macrophage colony-stimulating factor (GMCSF) and a tdTomato fluorophore. As the assessment of immunological responses to human transgenes is challenging in the most commonly used animal models, we used immunocompetent Syrian golden hamsters, known to be sensitive to human GMCSF and semipermissive to vaccinia virus. Efficacy was initially tested in vitro on various human and hamster cell lines and oncolytic potency of transgene-carrying viruses was similar to unarmed virus. The hGMCSF-encoding virus was able to completely eradicate subcutaneous pancreatic tumors in hamsters, and to fully protect the animals from subsequent rechallenge with the same tumor. Induction of specific antitumor immunity was also shown by ex vivo co-culture experiments with hamster splenocytes. In addition, histological examination revealed increased infiltration of neutrophils and macrophages in GMCSF-virus-treated tumors. These findings help clarify the mechanism of action of GMCSF-armed vaccinia viruses undergoing clinical trials. PMID:25042001

  2. The Asteroid Redirect Mission (ARM)

    Science.gov (United States)

    Abell, Paul; Gates, Michele; Johnson, Lindley; Chodas, Paul; Mazanek, Dan; Reeves, David; Ticker, Ronald

    2016-07-01

    To achieve its long-term goal of sending humans to Mars, the National Aeronautics and Space Administration (NASA) plans to proceed in a series of incrementally more complex human spaceflight missions. Today, human flight experience extends only to Low-Earth Orbit (LEO), and should problems arise during a mission, the crew can return to Earth in a matter of minutes to hours. The next logical step for human spaceflight is to gain flight experience in the vicinity of the Moon. These cis-lunar missions provide a "proving ground" for the testing of systems and operations while still accommodating an emergency return path to the Earth that would last only several days. Cis-lunar mission experience will be essential for more ambitious human missions beyond the Earth-Moon system, which will require weeks, months, or even years of transit time. In addition, NASA has been given a Grand Challenge to find all asteroid threats to human populations and know what to do about them. Obtaining knowledge of asteroid physical properties combined with performing technology demonstrations for planetary defense provide much needed information to address the issue of future asteroid impacts on Earth. Hence the combined objectives of human exploration and planetary defense give a rationale for the Asteroid Re-direct Mission (ARM). Mission Description: NASA's ARM consists of two mission segments: 1) the Asteroid Redirect Robotic Mission (ARRM), the first robotic mission to visit a large (greater than ~100 m diameter) near-Earth asteroid (NEA), collect a multi-ton boulder from its surface along with regolith samples, demonstrate a planetary defense technique, and return the asteroidal material to a stable orbit around the Moon; and 2) the Asteroid Redirect Crewed Mission (ARCM), in which astronauts will take the Orion capsule to rendezvous and dock with the robotic vehicle, conduct multiple extravehicular activities to explore the boulder, and return to Earth with samples. NASA's proposed

  3. Cardiopulmonary Responses to Supine Cycling during Short-Arm Centrifugation

    Science.gov (United States)

    Vener, J. M.; Simonson, S. R.; Stocks, J.; Evettes, S.; Bailey, K.; Biagini, H.; Jackson, C. G. R.; Greenleaf, J. E.; Dalton, Bonnie P. (Technical Monitor)

    2001-01-01

    The purpose of this study was to investigate cardiopulmonary responses to supine cycling with concomitant +G(sub z) acceleration using the NASA/Ames Human Powered Short-Arm Centrifuge (HPC). Subjects were eight consenting males (32+/-5 yrs, 178+/-5 cm, 86.1+/- 6.2 kg). All subjects completed two maximal exercise tests on the HPC (with and without acceleration) within a three-day period. A two tailed t-test with statistical significance set at p less than or equal to 0.05 was used to compare treatments. Peak acceleration was 3.4+/-0.1 G(sub z), (head to foot acceleration). Peak oxygen uptake (VO2(sub peak) was not different between treatment groups (3.1+/-0.1 Lmin(exp -1) vs. 3.2+/-0.1 Lmin(exp -1) for stationary and acceleration trials, respectively). Peak HR and pulmonary minute ventilation (V(sub E(sub BTPS))) were significantly elevated (p less than or equal to 0.05) for the acceleration trial (182+/-3 BPM (Beats per Minute); 132.0+/-9.0 Lmin(exp -1)) when compared to the stationary trial (175+/-3 BPM; 115.5+/-8.5 Lmin(exp -1)). Ventilatory threshold expressed as a percent of VO2(sub peak) was not different for acceleration and stationary trials (72+/-2% vs. 68+/-2% respectively). Results suggest that 3.4 G(sub z) acceleration does not alter VO2(sub peak) response to supine cycling. However, peak HR and V(sub E(sub BTPS)) response may be increased while ventilatory threshold response expressed as a function of percent VO2(sub peak) is relatively unaffected. Thus, traditional exercise prescription based on VO2 response would be appropriate for this mode of exercise. Prescriptions based on HR response may require modification.

  4. The Move from Accuracy Studies to Randomized Trials in PET

    DEFF Research Database (Denmark)

    Siepe, Bettina; Hoilund-Carlsen, Poul Flemming; Gerke, Oke;

    2014-01-01

    Since the influential study by van Tinteren et al. published in The Lancet in 2002, there have been an increasing number of diagnostic randomized controlled trials (RCTs) investigating the benefit of PET. If they provide valid and useful information on the benefit, these studies can play an impor......Since the influential study by van Tinteren et al. published in The Lancet in 2002, there have been an increasing number of diagnostic randomized controlled trials (RCTs) investigating the benefit of PET. If they provide valid and useful information on the benefit, these studies can play...... of diagnostic randomized trials, in which PET was applied in only one arm. We covered published studies as well as registered unpublished and planned studies. We considered 3 quality indicators related to the usefulness of a trial to generate evidence for a clinical benefit: use of patient-important outcome...

  5. Effects of Four-Week Supplementation with a Multi-Vitamin/Mineral Preparation on Mood and Blood Biomarkers in Young Adults: A Randomised, Double-Blind, Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    David J. White

    2015-10-01

    Full Text Available This study explored the effects of four-week multi-vitamin and mineral (MVM supplementation on mood and neurocognitive function in healthy, young adults. Fifty-eight healthy adults, 18–40 years of age (M = 25.82 years, SD = 4.87 participated in this randomised, double-blind, placebo-controlled trial, in which mood and blood biomarkers were assessed at baseline and after four weeks of supplementation. Compared to placebo, MVM supplementation was associated with significantly lowered homocysteine and increased blood B-vitamin levels (p < 0.01. MVM treatment was also associated with significantly improved mood, as measured by reduced scores on the “depression-dejection” subscale of the Profile of Mood States (p = 0.018. These findings suggest that the four weeks of MVM supplementation may have beneficial effects on mood, underpinned by elevated B-vitamins and lowered homocysteine in healthy young adults.

  6. Serious adverse event reporting in investigator-initiated clinical trials.

    Science.gov (United States)

    Wallace, Sophie; Myles, Paul S; Zeps, Nikolajs; Zalcberg, John R

    2016-04-01

    Reporting adverse events (AEs) and serious AEs (SAEs) are practical steps to ensure safety for volunteers and patients in medical research involving medications, treatments and devices. However, the burden and cost of reporting should be proportionate with the public health benefit of this information. Unfortunately, in Australia there is clear evidence of ever-increasing requirements from sponsors and ethics committees to report AEs and SAEs unnecessarily, leading to a decrease in the uptake of research, particularly less well funded investigator-initiated trials. We believe that individual AE reports to ethics committees serve no useful purpose, because in most cases the study group identity (drug exposure) is not known in studies with blinded treatment arms and their value is limited. Pragmatic, investigator-initiated Phase IV clinical trials of post-marketed drugs or devices are needed to understand their role in everyday clinical practice. In this setting, the workload and costs of systematic, complete reporting of all AEs and SAEs (independent of whether these are treatment-related) is wasteful, and mostly unnecessary. A trial data safety and monitoring committee is in the unique position of being able to review safety information according to the blinded treatment arms of the study. This enables safety data to be analysed appropriately and a summary report provided to the trial steering committee, principal investigators and the relevant ethics committees in a meaningful way. Defined trial endpoints do not need to be reported as safety events (because they are being properly monitored and analysed). PMID:27031396

  7. Clinical Trial Results: A Clinical Trial Bazaar!

    OpenAIRE

    Fojo, Antonio Tito; Bates, Susan E.

    2014-01-01

    The Oncologist’s Clinical Trial Results section welcomes both positive and negative results in an effort to share information, speed discovery, and inform the field. Clinical Trial Results submissions have shown how succinctly the salient features of a submission can be presented, with more in-depth information to be found online.

  8. Augmented Designs to Assess Immune Response in Vaccine Trials

    OpenAIRE

    Follmann, Dean

    2006-01-01

    This article introduces methods for use in vaccine clinical trials to help determine whether the immune response to a vaccine is actually causing a reduction in the infection rate. This is not easy because immune response to the (say HIV) vaccine is only observed in the HIV vaccine arm. If we knew what the HIV-specific immune response in placebo recipients would have been, had they been vaccinated, this immune response could be treated essentially like a baseline covariate and an interaction ...

  9. Clinical trials of neutron radiotherapy in the united states

    International Nuclear Information System (INIS)

    The Radiation Therapy Oncology Group (RTOG) and the Medical Research Council (MRC) jointly sponsored a randomized trial for the treatment of advanced stage salivary gland tumors comparing neutron to conventional photon and/or electron radiotherapy. No improvement in survival was seen, the study demonstrated a striking and statistically significant difference in the local-regional control of unresectable salivary gland tumors (56 vs 17 %), favoring neutron beam irradiation. Subsequent clinical trials of neutron beam irradiation were initiated by the Neutron Therapy Collaborative Working Group (NTCWG) sponsored by the National Cancer Institute (NCI). A phase III trial comparing neutron to photon radiotherapy for inoperable regional non-small cell lung cancer showed no overall improvement in survival. A statistically significant improvement in survival was observed in the subset of patients with squamous cell histology. The NTCWG trial comparing fast-neutron therapy versus conventional photon irradiation in the treatment of advanced squamous cell carcinomas of the head and neck showed a statistically significant improvement in initial complete response (70 vs 52 %) favoring neutrons. Subsequent failures erased any difference in ultimate local(regional control rates and survival curves were essentially the same in both arms. The randomized study of the NTCWG for locally advanced prostate cancer demonstrated a significant decrease in local-regional failure (11 vs 32 %) at 5 years, favoring the neutron arm. Biochemical measures of disease control also favored the neutron arm with prostate specific antigen (PSA) levels elevated in 17 % of the neutron-treated patients compared to 45 % of he photon-treated patients at 5 years. At the 5-years analysis, no significant difference in survival was observed between the two arms; longer follow-up is necessary to assess the ultimate impact of improved local-regional control on survival. An analysis of complications in this series

  10. The evolution of neuroArm.

    Science.gov (United States)

    Sutherland, Garnette R; Wolfsberger, Stefan; Lama, Sanju; Zarei-nia, Kourosh

    2013-01-01

    Intraoperative imaging disrupts the rhythm of surgery despite providing an excellent opportunity for surgical monitoring and assessment. To allow surgery within real-time images, neuroArm, a teleoperated surgical robotic system, was conceptualized. The objective was to design and manufacture a magnetic resonance-compatible robot with a human-machine interface that could reproduce some of the sight, sound, and touch of surgery at a remote workstation. University of Calgary researchers worked with MacDonald, Dettwiler and Associates engineers to produce a requirements document, preliminary design review, and critical design review, followed by the manufacture, preclinical testing, and clinical integration of neuroArm. During the preliminary design review, the scope of the neuroArm project changed to performing microsurgery outside the magnet and stereotaxy inside the bore. neuroArm was successfully manufactured and installed in an intraoperative magnetic resonance imaging operating room. neuroArm was clinically integrated into 35 cases in a graded fashion. As a result of this experience, neuroArm II is in development, and advances in technology will allow microsurgery within the bore of the magnet. neuroArm represents a successful interdisciplinary collaboration. It has positive implications for the future of robotic technology in neurosurgery in that the precision and accuracy of robots will continue to augment human capability. PMID:23254809

  11. Naval arms control: Tons of options?

    International Nuclear Information System (INIS)

    Arms reductions have reached the US Navy, the most arms control averse of the US services, with budget-driven cuts in numbers of ships and personnel, and President Bush's unilateral withdrawal of tactical nuclear weapons. Soviet President Mikhail Gorbachev's rejoinder not only replicated the Bush initiative for naval weapons, but also called for the destruction of all those weapons, many of which would simply be placed in secure storage ashore under Bush's approach. Can formal, negotiated naval arms control agreements be far behind? Post-war history suggests that such naval arms agreements will remain out of reach. But post-war history has been confounded repeatedly by the events of the past three years. There are, in fact, negotiated naval limits that would enhance the predictability of US-Soviet military relations, and smooth the path of the naval retrenchment already underway on both sides. The Bush-Gorbachev reciprocal withdrawals of naval tactical nuclear arms deal with the most urgent and dangerous issue for naval arms control, improve the US Navy's survivability by drastically reducing the nuclear threat, and improve its flexibility by eliminating the security and political issues associated with carrying nuclear arms. It would be highly desirable, however, to formalize and verify these withdrawals, placing withdrawn weapons under jointly monitored, secure control, to preserve options for further cuts in the future

  12. Light duty utility arm walkdown report

    Energy Technology Data Exchange (ETDEWEB)

    Smalley, J.L.

    1998-09-25

    This document is a report of the Light Duty Utility Arm (LDUA) drawing walkdown. The purpose of this walkdown was to validate the essential configuration of the LDUA in preparation of deploying the equipment in a Hanford waste tank. The LDUA system has, over the course of its development, caused the generation of a considerable number of design drawings. The number of drawings is estimated to be well over 1,000. A large number consist of vendor type drawings, furnished by both Pacific Northwest National Laboratory (PNNL) and SPAR Aerospace Limited (SPAR). A smaller number, approximately 200, are H-6 type drawing sheets in the Project Hanford Management Contract (PHMC) document control system. A preliminary inspection of the drawings showed that the physical configuration of the LDUA did not match the documented configuration. As a result of these findings, a scoping walkdown of 20 critical drawing sheets was performed to determine if a problem existed in configuration management of the LDUA system. The results of this activity showed that 18 of the 20 drawing sheets were found to contain errors or omissions of varying concern. Given this, Characterization Engineering determined that a walkdown of the drawings necessary and sufficient to enable safe operation and maintenance of the LDUA should be performed. A review team was assembled to perform a review of all of the drawings and determine the set which would need to be verified through an engineering walkdown. The team determined that approximately 150 H-6 type drawing sheets would need to be verified, 12 SPAR/PNNL drawing sheets would need to be verified and converted to H-6 drawings, and three to six new drawings would be created (see Appendix A). This report documents the results of that walkdown.

  13. Light duty utility arm walkdown report

    International Nuclear Information System (INIS)

    This document is a report of the Light Duty Utility Arm (LDUA) drawing walkdown. The purpose of this walkdown was to validate the essential configuration of the LDUA in preparation of deploying the equipment in a Hanford waste tank. The LDUA system has, over the course of its development, caused the generation of a considerable number of design drawings. The number of drawings is estimated to be well over 1,000. A large number consist of vendor type drawings, furnished by both Pacific Northwest National Laboratory (PNNL) and SPAR Aerospace Limited (SPAR). A smaller number, approximately 200, are H-6 type drawing sheets in the Project Hanford Management Contract (PHMC) document control system. A preliminary inspection of the drawings showed that the physical configuration of the LDUA did not match the documented configuration. As a result of these findings, a scoping walkdown of 20 critical drawing sheets was performed to determine if a problem existed in configuration management of the LDUA system. The results of this activity showed that 18 of the 20 drawing sheets were found to contain errors or omissions of varying concern. Given this, Characterization Engineering determined that a walkdown of the drawings necessary and sufficient to enable safe operation and maintenance of the LDUA should be performed. A review team was assembled to perform a review of all of the drawings and determine the set which would need to be verified through an engineering walkdown. The team determined that approximately 150 H-6 type drawing sheets would need to be verified, 12 SPAR/PNNL drawing sheets would need to be verified and converted to H-6 drawings, and three to six new drawings would be created (see Appendix A). This report documents the results of that walkdown

  14. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... determine if the drug can be approved for use. A Phase I trial tests an experimental treatment ... the correct drug dosage. A Phase II trial uses more people (100 to 300). While the emphasis ...

  15. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... the body laboratory tests that check samples of blood, urine, or other body tissues genetic tests that look for genes linked to some types of disease. Diagnostic Trials In diagnostic trials, researchers ...

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical ... researchers may gather information about experimental treatments, their risks, and how well they work compare existing therapies ...

  17. Research Areas - Clinical Trials

    Science.gov (United States)

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

  18. Research Areas: Clinical Trials

    Science.gov (United States)

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

  19. ARM Climate Research Facility Annual Report 2005

    Energy Technology Data Exchange (ETDEWEB)

    J. Voyles

    2005-12-31

    Through the ARM Program, the DOE funded the development of several highly instrumented ground stations for studying cloud formation processes and their influence on radiative transfer, and for measuring other parameters that determine the radiative properties of the atmosphere. This scientific infrastructure, and resultant data archive, is a valuable national and international asset for advancing scientific knowledge of Earth systems. In fiscal year (FY) 2003, the DOE designated ARM sites as a national scientific user facility: the ARM Climate Research (ACRF). The ACRF has enormous potential to contribute to a wide range interdisciplinary science in areas such as meteorology, atmospheric aerosols, hydrology, biogeochemical cycling, and satellite validation, to name only a few.

  20. Pitch angle of galactic spiral arms

    International Nuclear Information System (INIS)

    One of the key parameters that characterizes spiral arms in disk galaxies is a pitch angle that measures the inclination of a spiral arm to the direction of galactic rotation. The pitch angle differs from galaxy to galaxy, which suggests that the rotation law of galactic disks determines it. In order to investigate the relation between the pitch angle of spiral arms and the shear rate of galactic differential rotation, we perform local N-body simulations of pure stellar disks. We find that the pitch angle increases with the epicycle frequency and decreases with the shear rate and obtain the fitting formula. This dependence is explained by the swing amplification mechanism.

  1. Arms control, nonproliferation, and US national security

    International Nuclear Information System (INIS)

    The continuation of the arms race and the failure of arms control and disarmament negotiations lend support to the belief that US and Soviet power, prestige, and security depend upon nuclear weapons. Therefore, the argument goes, the non-nuclear-weapon states (particularly those that are not allied with nuclear-weapon states and do not share their nuclear shield) may conclude that they would be well served by possession of these weapons. In this sense, the failure of nuclear arms reductions could create incentives for further proliferation

  2. Preparation of poly(epsilon-caprolactone)-based tissue engineering scaffolds by stereolithography

    NARCIS (Netherlands)

    Elomaa, Laura; Teixeira, Sandra; Hakala, Risto; Korhonen, Harri; Grijpma, Dirk W.; Seppala, Jukka V.

    2011-01-01

    A photocrosslinkable poly(epsilon-caprolactone) (PCL)-based resin was developed and applied using stereolithography. No additional solvents were required during the structure preparation process. Three-armed PCL oligomers of varying molecular weights were synthesized, functionalized with methacrylic

  3. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... was provided by the National Library of Medicine Topic last reviewed: December 2013 For an enhanced version of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is ...

  4. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... topic was provided by the National Library of Medicine Topic last reviewed: December 2013 For an enhanced version of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study ...

  5. A study of the Perkin-Elmer laboratory robotic system for analytical sample preparation

    Energy Technology Data Exchange (ETDEWEB)

    Hartenstein, S.D.; Delmastro, J.R.

    1988-09-01

    The purpose of this study was to evaluate the abilities of a Perkin-Elmer (PE) robotic system in performing complex analytical sample preparation procedures. Until this time, reports have been written describing the physical capabilities of the robotic arm marketed by PE and the use of this arm in a pick-and-place application at the Idaho Chemical Processing Plant (ICPP). Since the robotic arm is only capable of handling and transporting objects, the ability of the PE system is dependent upon the performance capabilities of the auxiliary devices marketed with the arm. 2 refs., 2 figs., 1 tab.

  6. Effects of switching to PI monotherapy on measures of lipoatrophy: meta-analysis of six randomized HIV clinical trials

    Directory of Open Access Journals (Sweden)

    J Arribas

    2012-11-01

    Full Text Available Background: Switching from triple combination treatment to protease inhibitor (PI monotherapy may prevent or reverse adverse events related to long-term nucleoside analogues. Lipoatrophy is associated with long-term use of thymidine analogues (zidovudine and stavudine. Methods: A detailed MEDLINE search was conducted to identify randomised clinical trials of triple combination treatment versus PI monotherapy. Summary results from analysis of changes in body composition (DEXA analysis were collected: the mean change in limb fat and trunk fat to Week 48 or 96, and the percentage of patients with lipoatrophy (20% reduction from baseline in limb fat or lipohypertrophy (20% rise from baseline in trunk fat. Results: Six randomised trials of PI monotherapy versus triple therapy with data on body composition changes, measured by DEXA scanning at baseline and Week 48 or 96, were identified: Abbott-613 (LPV/r vs ZDV/3TC/EFV, induction-maintenance trial, n=105, Monark (LPV/r vs ZDV/3TC/LPV/r, first-line trial, n=63, Kalesolo (LPV/r vs LPV/r +2NRTIs, switch trial, n=42, MONOI (DRV/r vs DRV/r + 2NRTIs, switch trial, n=156, MONARCH (DRV/r vs DRV/r + 2NRTIs, switch trial, n=30 and KRETA (LPV/r vs LPV/r + ABC/3TC, switch trial, n=74. In the meta-analysis, there were greater rises in limb fat in the PI monotherapy arms than the triple therapy arms (mean difference =277g, 95% CI=+36 to+517g, p=0.024. The percentage of patients with lipoatrophy was significantly lower in the PI monotherapy arms (4% than the triple therapy arms (20%, (p=0.0005. There was no difference between PI monotherapy and triple therapy for mean change in trunk fat (mean difference=−73g, 95% CI = −621 to +475g, p=ns. There was also no significant difference in the risk of lipohypertrophy between the PI monotherapy arms (32% and the triple therapy arms (27% (p=ns. In each of the four analyses, there was no evidence for heterogeneity of treatment effects between the trials (Cochran's Q

  7. Traditional invasive vs. minimally invasive esophagectomy: a multi-center, randomized trial (TIME-trial

    Directory of Open Access Journals (Sweden)

    de Lange Elly SM

    2011-01-01

    Full Text Available Abstract Background There is a rise in incidence of esophageal carcinoma due to increasing incidence of adenocarcinoma. Probably the only curative option to date is the use of neoadjuvant therapy followed by surgical resection. Traditional open esophageal resection is associated with a high morbidity and mortality rate. Furthermore, this approach involves long intensive care unit stay, in-hospital stay and long recovery period. Minimally invasive esophagectomy could reduce the morbidity and accelerate the post-operative recovery. Methods/Design Comparison between traditional open and minimally invasive esophagectomy in a multi-center, randomized trial. Patients with a resectable intrathoracic esophageal carcinoma, including the gastro-esophageal junction tumors (Siewert I are eligible for inclusion. Prior thoracic surgery and cervical esophageal carcinoma are indications for exclusion. The surgical technique involves a right thoracotomy with lung blockade and laparotomy either with a cervical or thoracic anastomosis for the traditional group. The minimally invasive procedure involves a right thoracoscopy in prone position with a single lumen tube and laparoscopy either with a cervical or thoracic anastomosis. All patients in both groups will undergo identical pre-operative and post-operative protocol. Primary endpoint of this study are post-operative respiratory complications within the first two post-operative weeks confirmed by clinical, radiological and sputum culture data. Secondary endpoints are the operative data, the post-operative data and oncological data such as quality of the specimen and survival. Operative data include duration of the operation, blood loss and conversion to open procedure. Post-operative data include morbidity (major and minor, quality of life tests and hospital stay. Based on current literature and the experience of all participating centers, an incidence of pulmonary complications for 57% in the traditional arm

  8. Adherence to yoga and exercise interventions in a 6-month clinical trial

    OpenAIRE

    de Haas M; Zajdel D; Kishiyama S; Flegal KE; BS, Oken

    2007-01-01

    Abstract Background To determine factors that predict adherence to a mind-body intervention in a randomized trial. Design We analyzed adherence data from a 3-arm trial involving 135 generally healthy seniors 65–85 years of age randomized to a 6-month intervention consisting of: an Iyengar yoga class with home practice, an exercise class with home practice, or a wait-list control group. Outcome measures included cognitive function, mood, fatigue, anxiety, health-related quality of life, and ph...

  9. Cognitive–behavioural therapy v. structured care for medically unexplained symptoms: randomised controlled trial

    OpenAIRE

    Sumathipala, A.; Siribaddana, S.; Abeysingha, M. R. N.; Silva, P.; Dewey, M; Prince, M.; Mann, A.H.

    2008-01-01

    Background A pilot trial in Sri Lanka among patients with medically unexplained symptoms revealed that cognitive–behavioural therapy (CBT) administered by a psychiatrist was efficacious. Aims To evaluate CBT provided by primary care physicians in a comparison with structured care. Method A randomised control trial (n=75 in each arm) offered six 30 min sessions of structured care or therapy. The outcomes of the two interventions were compared at 3 months, 6 months, 9 months and 12 months. Resu...

  10. Protocol of the Home-based Older People's Exercise (HOPE) trial

    OpenAIRE

    Iliffe, S. R.; Clegg, A.; Barber, S.; Young, J.; Forster, A.

    2011-01-01

    Background: Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design: The Home-Based Older People’s Exercise (HOPE) trial is a two arm, assessor blind pilot randomised controlled trial (RCT) to assess t...

  11. The spiral arms of the Milky Way: The relative location of each different arm tracer within a typical spiral arm width

    Energy Technology Data Exchange (ETDEWEB)

    Vallée, Jacques P., E-mail: jacques.vallee@nrc-cnrc.gc.ca [National Research Council Canada, National Science Infrastructure portfolio, Herzberg Astronomy and Astrophysics, 5071 West Saanich Road, Victoria, B.C., V9E 2E7 (Canada)

    2014-07-01

    From the Sun's location in the Galactic disk, different arm tracers (CO, H I, hot dust, etc.) have been employed to locate a tangent to each spiral arm. Using all various and different observed spiral arm tracers (as published elsewhere), we embark on a new goal, namely the statistical analysis of these published data (data mining) to statistically compute the mean location of each spiral arm tracer. We show for a typical arm cross-cut, a separation of 400 pc between the mid-arm and the dust lane (at the inner edge of the arm, toward the Galactic center). Are some arms major and others minor? Separating arms into two sets, as suggested by some, we find the same arm widths between the two sets. Our interpretation is that we live in a multiple (four-arm) spiral (logarithmic) pattern (around a pitch angle of 12°) for the stars and gas in the Milky Way, with a sizable interarm separation (around 3 kpc) at the Sun's location and the same arm width for each arm (near 400 pc from mid-arm to dust lane).

  12. The spiral arms of the Milky Way: The relative location of each different arm tracer within a typical spiral arm width

    International Nuclear Information System (INIS)

    From the Sun's location in the Galactic disk, different arm tracers (CO, H I, hot dust, etc.) have been employed to locate a tangent to each spiral arm. Using all various and different observed spiral arm tracers (as published elsewhere), we embark on a new goal, namely the statistical analysis of these published data (data mining) to statistically compute the mean location of each spiral arm tracer. We show for a typical arm cross-cut, a separation of 400 pc between the mid-arm and the dust lane (at the inner edge of the arm, toward the Galactic center). Are some arms major and others minor? Separating arms into two sets, as suggested by some, we find the same arm widths between the two sets. Our interpretation is that we live in a multiple (four-arm) spiral (logarithmic) pattern (around a pitch angle of 12°) for the stars and gas in the Milky Way, with a sizable interarm separation (around 3 kpc) at the Sun's location and the same arm width for each arm (near 400 pc from mid-arm to dust lane).

  13. Youth Armed Groups in Colombia

    Directory of Open Access Journals (Sweden)

    Linda Dale

    2014-09-01

    Full Text Available For the many years of Colombia’s civil war, youth have been trying to find their way in complicated and dangerous situations. A central component of this is their relationship with armed groups, something that has evolved considerably over the past ten years. This practice note examines the context within which these connections are formed and the implications this has for self/social identity and meaningful resistance. The ideas in this practice note are based on consultations with young Colombians, particularly those displaced from 2000-2013. These sessions included art activities, focus groups and individual interviews. Art activities involved descriptive and expressive projects so that participants could explore their feelings and memories of situations and experiences. This provided a base for group discussions where youth exchanged information and debated issues. A total of 34 workshops were held over a twelve year period. These consultations revealed how war flows all over young people, touching every aspect of their identity. The boundaries between the personal and political no longer exist in today’s civil wars, if indeed they every truly did. Young people growing up inside Colombia’s war understand this at a deep level. An acknowledgement of this pain – showing the connections between the personal and political dimensions of war – is, they would maintain, the basis for their personal healing as well as an important tool for the building of sustainable peace.

  14. AIDS Clinical Trials Group Network

    Science.gov (United States)

    ... Center Statistical and Data Management Center Glossaries Sites Clinical Trials About the Trial Process Trials Open to Enrollment Recent Study Results Access to Published Data Clinical Trials Resources Committees Executive Scientific Resource Community General Information ...

  15. Molecular clouds in the Carina arm

    Science.gov (United States)

    Cohen, R. S.; Grabelsky, D. A.; May, J.; Alvarez, H.; Bronfman, L.; Thaddeus, P.

    1985-01-01

    From a new survey of the 2.6 mm line of CO in the southern Milky Way, 37 molecular clouds were identified along the Carina arm from l = 282 deg to 336 deg with masses generally greater than 10 to the 5th solar mass. The clouds lie approximately every 700 pc along a spiral segment that is nearly 25 kpc long and has a pitch of about 10 deg. The total mass of these clouds is 40 x 10 to the 6th solar mass, or rougly 1 x 10 to the 6th solar mass each on average. The abrupt tangent point in molecular clouds at l = 280 deg and the characteristic loop structure in the l-v diagram are unmistakable evidence of a CO spiral arm in Carina. This arm apparently connects with the northern hemisphere Sagittarius arm to form a single 10 deg spiral which extends more than two-thirds of the way around the Galaxy.

  16. Arming and firing system for DISTANT RUNNER

    International Nuclear Information System (INIS)

    Sandia A and F systems Division 1132 provided arming and firing support for the DISTANT RUNNER Test Program at White Sands Missile Range. This report describes the field support and the firing system that was used

  17. Optimal control model of arm configuration in a reaching task

    Science.gov (United States)

    Yamaguchi, Gary T.; Kakavand, Ali

    1996-05-01

    It was hypothesized that the configuration of the upper limb during a hand static positioning task could be predicted using a dynamic musculoskeletal model and an optimal control routine. Both rhesus monkey and human upper extremity models were formulated, and had seven degrees of freedom (7-DOF) and 39 musculotendon pathways. A variety of configurations were generated about a physiologically measured configuration using the dynamic models and perturbations. The pseudoinverse optimal control method was applied to compute the minimum cost C at each of the generated configurations. Cost function C is described by the Crowninshield-Brand (1981) criterion which relates C (the sum of muscle stresses squared) to the endurance time of a physiological task. The configuration with the minimum cost was compared to the configurations chosen by one monkey (four trials) and by eight human subjects (eight trials each). Results are generally good, but not for all joint angles, suggesting that muscular effort is likely to be one major factor in choosing a preferred static arm posture.

  18. 49 CFR 234.255 - Gate arm and gate mechanism.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Gate arm and gate mechanism. 234.255 Section 234... Maintenance, Inspection, and Testing Inspections and Tests § 234.255 Gate arm and gate mechanism. (a) Each gate arm and gate mechanism shall be inspected at least once each month. (b) Gate arm movement shall...

  19. 27 CFR 479.193 - Arms Export Control Act.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false Arms Export Control Act... CERTAIN OTHER FIREARMS Other Laws Applicable § 479.193 Arms Export Control Act. For provisions relating to... exporting arms, ammunition, or implements of war, see the Arms Export Control Act (22 U.S.C. 2778), and...

  20. 31 CFR 547.301 - Arms or any related materiel.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Arms or any related materiel. 547.301... REGULATIONS General Definitions § 547.301 Arms or any related materiel. The term arms or any related materiel means arms or related materiel of all types, including military aircraft and equipment, but excludes:...

  1. 31 CFR 546.301 - Arms or any related materiel.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Arms or any related materiel. 546.301 Section 546.301 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE... Definitions § 546.301 Arms or any related materiel. The term arms or any related materiel shall mean arms...

  2. Understanding noninferiority trials

    Directory of Open Access Journals (Sweden)

    Seokyung Hahn

    2012-11-01

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

  3. Comparison of Arm and Interarm Molecular Clouds

    Science.gov (United States)

    Lee, Y.; Kim, H. G.; Moon, D. S.; Stark, A. A.

    1999-01-01

    The physical properties of the molecular clouds in the arm and interarm region of the inner Galalxy are compared. We used Bell Laboratories Galactic Plane 13CO Survey data and UMSB Galactic Plane 12CO Survey data. The LCO/M of the interarm molecular clouds is much smaller that of arm molecular clouds. Several physical properties, including abundance ratio of molecular clouds in two regions are discussed.

  4. Accounting for complex entities: implications for ARMS

    OpenAIRE

    Moss, Charles B.; Klinefelter, Danny A.

    2012-01-01

    Purpose – The purpose of this research is to examine the effect of accounting for complex organizational forms on data collection with the Agricultural Resource Management Survey (ARMS). Design/methodology/approach – This research reviews the literature from accounting theory along with the goals of data collection for policy analysis to draw conclusions about the applicability of accounting pronouncements. Findings – Historically, the financial data collected in ARMS were based on financial ...

  5. Making birthing safe for Pakistan women: a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Khan Muhammad

    2012-07-01

    Full Text Available Abstract Background Two out of three neonatal deaths occur in just 10 countries and Pakistan stands third among them. Maternal mortality is also high with most deaths occurring during labor, birth, and first few hours after birth. Enhanced access and utilization of skilled delivery and emergency obstetric care is the demonstrated strategy in reducing maternal and neonatal mortality. This trial aims to compare reduction in neonate mortality and utilization of available safe birthing and Emergency Obstetric and Neonatal Care services among pregnant mothers receiving ‘structured birth planning’, and/or ‘transport facilitation’ compared to routine care. Methods A pragmatic cluster randomized trial, with qualitative and economic studies, will be conducted in Jhang, Chiniot and Khanewal districts of Punjab, Pakistan, from February 2011 to May 2013. At least 29,295 pregnancies will be registered in the three arms, seven clusters per arm; 1 structured birth planning and travel facilitation, 2 structured birth planning, and 3 control arm. Trial will be conducted through the Lady Health Worker program. Main outcomes are difference in neonatal mortality and service utilization; maternal mortality being the secondary outcome. Cluster level analysis will be done according to intention-to-treat. Discussion A nationwide network of about 100,000 lady health workers is already involved in antenatal and postnatal care of pregnant women. They also act as “gatekeepers” for the child birthing services. This gate keeping role mainly includes counseling and referral for skill birth attendance and travel arrangements for emergency obstetric care (if required. The review of current arrangements and practices show that the care delivery process needs enhancement to include adequate information provision as well as informed “decision” making and planned “action” by the pregnant women. The proposed three-year research is to develop, through national

  6. Bioconjugated PLGA-4-arm-PEG branched polymeric nanoparticles as novel tumor targeting carriers

    International Nuclear Information System (INIS)

    In this study, we have developed a novel carrier, micelle-type bioconjugated PLGA-4-arm-PEG branched polymeric nanoparticles (NPs), for the detection and treatment of pancreatic cancer. These NPs contained 4-arm-PEG as corona, and PLGA as core, the particle surface was conjugated with cyclo(arginine-glycine-aspartate) (cRGD) as ligand for in vivo tumor targeting. The hydrodynamic size of the NPs was determined to be 150-180 nm and the critical micellar concentration (CMC) was estimated to be 10.5 mg l-1. Our in vitro study shows that these NPs by themselves had negligible cytotoxicity to human pancreatic cancer (Panc-1) and human glioblastoma (U87) cell lines. Near infrared (NIR) microscopy and flow cytometry demonstrated that the cRGD conjugated PLGA-4-arm-PEG polymeric NPs were taken up more efficiently by U87MG glioma cells, over-expressing the αvβ3 integrin, when compared with the non-targeted NPs. Whole body imaging showed that the cRGD conjugated PLGA-4-arm-PEG branched polymeric NPs had the highest accumulation in the pancreatic tumor site of mice at 48 h post-injection. Physical, hematological, and pathological assays indicated low in vivo toxicity of this NP formulation. These studies on the ability of these bioconjugated PLGA-4-arm-PEG polymeric NPs suggest that the prepared polymeric NPs may serve as a promising platform for detection and targeted drug delivery for pancreatic cancer.

  7. Impaired motor preparation and execution during standing reach in people with chronic stroke.

    Science.gov (United States)

    McCombe Waller, Sandy; Yang, Chieh-Ling; Magder, Laurence; Yungher, Don; Gray, Vicki; Rogers, Mark W

    2016-09-01

    Movement preparation of both anticipatory postural adjustments (APAs) and goal directed movement during a standing reaching task in adults with chronic hemiparesis and healthy controls was investigated. Using a simple reaction time paradigm, while standing on two separate force platforms, subjects received a warning light cue to "get ready to reach" followed 2.5s later by an imperative light cue to "reach as quickly as possible" with the paretic arm (matched arm for controls) to touch a target in front of them for a total of 90 trials. In 30 of the reaching trials a loud acoustic stimulus (LAS) of 123 dB was randomly - -200, or 0ms relative to the "go" cue. APA (postural) responses were characterized by the onset and maximal posterior displacement of center of pressure (CoP) and onset/offset of electromyography (EMG) from tibialis anterior (TA), soleus (SOL), while reach was characterized by onset and maximal forward displacement of the reach hand and onset of the anterior (AD), biceps brachii (BB) and middle deltoid (MD). Subjects with stroke, demonstrated a marked reduction in the occurrence of the StartReact responses for both APA and forward reach at all LAS time points indicating movement preparation dysfunction. Movement execution during a cued reach showed significant delays in APA and reach onsets, significant reduction in the magnitude of APA (posterior CoP displacement) and reach excursion, and an increased latency between the APA and reach compared to controls. EMG activation patterns for the TA and SOL demonstrated co contraction compared to the temporally sequenced pattern of control subjects. When LAS was provided at the "go" there were earlier but not significant differences in APA onset latency compared to reaching without LAS and significant delays in reach onset latency when compared to control subjects with or without LAS. An early burst of EMG in biceps brachii muscles with a further delay of the reach onset compared to reaching without LAS may

  8. Assemble four-arm DNA junctions into nanoweb

    Institute of Scientific and Technical Information of China (English)

    2001-01-01

    DNA is of structural polymorphism, which is useful in nanoarchitecture; especially, four-arm DNA junc tions can be used to assemble nanowebs. The static four-arm DNA junctions were designed and synthesized. One-arm DNA and two-arm DNA came out simultaneously with the four-arm DNA junction's formation. A new method, termed the two-step method, was proposed and the productivity of four-arm DNA junctions was increased. A nanoweb was assembled successfully, but it showed irregularity itself. It was not the same as we expected. We consider that it is aresult from the flexibility of four-arm DNA junction.

  9. The RAZOR (randomized open vs robotic cystectomy) trial: study design and trial update

    Science.gov (United States)

    Smith, Norm D.; Castle, Erik P.; Gonzalgo, Mark L.; Svatek, Robert S.; Weizer, Alon Z.; Montgomery, Jeffrey S.; Pruthi, Raj S.; Woods, Michael E.; Tollefson, Matthew K.; Konety, Badrinath R.; Shabsigh, Ahmad; Krupski, Tracey; Barocas, Daniel A.; Dash, Atreya; Quek, Marcus L.; Kibel, Adam S.; Parekh, Dipen J.

    2016-01-01

    The purpose of the RAZOR (randomized open vs robotic cystectomy) study is to compare open radical cystectomy (ORC) vs robot-assisted RC (RARC), pelvic lymph node dissection (PLND) and urinary diversion for oncological outcomes, complications and health-related quality of life (HRQL) measures with a primary endpoint of 2-year progression-free survival (PFS). RAZOR is a multi-institutional, randomized, non-inferior, phase III trial that will enrol at least 320 patients with T1–T4, N0–N1, M0 bladder cancer with ≈160 patients in both the RARC and ORC arms at 15 participating institutions. Data will be collected prospectively at each institution for cancer outcomes, complications of surgery and HRQL measures, and then submitted to trial data management services Cancer Research and Biostatistics (CRAB) for final analyses. To date, 306 patients have been randomized and accrual to the RAZOR trial is expected to conclude in 2014. In this study, we report the RAZOR trial experimental design, objectives, data safety, and monitoring, and accrual update. The RAZOR trial is a landmark study in urological oncology, randomizing T1–T4, N0–N1, M0 patients with bladder cancer to ORC vs RARC, PLND and urinary diversion. RAZOR is a multi-institutional, non-inferiority trial evaluating cancer outcomes, surgical complications and HRQL measures of ORC vs RARC with a primary endpoint of 2-year PFS. Full data from the RAZOR trial are not expected until 2016–2017. PMID:25626182

  10. Safety and efficacy of combination therapy of interferon-alpha2 + JAK1-2 Inhibitor in the philadelphia-negative chronic myeloproliferative neoplasms. Preliminary results from the danish combi-trial-an open label, single arm, non-randomized multicenter phase II study

    DEFF Research Database (Denmark)

    Mikkelsen, S. U.; Kjaer, L.; Skov, V.;

    2015-01-01

    IFNa2 as well. The purpose of this COMBI-trial is to evaluate the safety and efficacy of CT with IFNa2 and ruxolitinib. Patients and Methods: At the time of data cutoff, a total of 30 pts >18 years with prefibrotic or hyperproliferative PMF (n=7), PV (n=20) or post-PV MF (PPV-MF) (n=3) with or without......Background: The Philadelphia-negative, chronic myeloproliferative neoplasms (MPN) include essential thrombocythemia (ET), polycythemia vera (PV) and primary myelofibrosis (MF) (PMF). Chronic inflammation and a deregulated immune system are considered important for clonal evolution and disease...... progression. Ruxolitinib is a potent anti-inflammatory agent and has shown great benefit in MPN patients (pts), reducing spleen size and inflammation-mediated symptoms, thereby improving quality of life (QoL). Interferon-alpha2 (IFNa2) has been used successfully for decades in the treatment of MPN. However...

  11. ARM assembly language with hardware experiments

    CERN Document Server

    Elahi, Ata

    2015-01-01

    This book provides a hands-on approach to learning ARM assembly language with the use of a TI microcontroller. The book starts with an introduction to computer architecture and then discusses number systems and digital logic. The text covers ARM Assembly Language, ARM Cortex Architecture and its components, and Hardware Experiments using TILM3S1968. Written for those interested in learning embedded programming using an ARM Microcontroller. ·         Introduces number systems and signal transmission methods   ·         Reviews logic gates, registers, multiplexers, decoders and memory   ·         Provides an overview and examples of ARM instruction set   ·         Uses using Keil development tools for writing and debugging ARM assembly language Programs   ·         Hardware experiments using a Mbed NXP LPC1768 microcontroller; including General Purpose Input/Output (GPIO) configuration, real time clock configuration, binary input to 7-segment display, creating ...

  12. Arm & Interarm Star Formation in Spiral Galaxies

    CERN Document Server

    Foyle, Kelly; Walter, Fabian; Leroy, Adam

    2010-01-01

    We investigate the relationship between spiral arms and star formation in the grand-design spirals NGC 5194 and NGC 628 and in the flocculent spiral NGC 6946. Filtered maps of near-IR (3.6 micron) emission allow us to identify "arm regions" that should correspond to regions of stellar mass density enhancements. The two grand-design spirals show a clear two-armed structure, while NGC 6946 is more complex. We examine these arm and interarm regions, looking at maps that trace recent star formation - far-ultraviolet (GALEX NGS) and 24 micron emission (Spitzer, SINGS) - and cold gas - CO (Heracles) and HI (Things). We find the star formation tracers and CO more concentrated in the spiral arms than the stellar 3.6 micron flux. If we define the spiral arms as the 25% highest pixels in the filtered 3.6 micron images, we find that the majority (60%) of star formation tracers occurs in the interarm regions; this result persists qualitatively even when considering the potential impact of finite data resolution and diffu...

  13. Solution preparation

    International Nuclear Information System (INIS)

    Reviewed in this statement are methods of preparing solutions to be used in laboratory experiments to examine technical issues related to the safe disposal of nuclear waste from power generation. Each approach currently used to prepare solutions has advantages and any one approach may be preferred over the others in particular situations, depending upon the goals of the experimental program. These advantages are highlighted herein for three approaches to solution preparation that are currently used most in studies of nuclear waste disposal. Discussion of the disadvantages of each approach is presented to help a user select a preparation method for his particular studies. Also presented in this statement are general observations regarding solution preparation. These observations are used as examples of the types of concerns that need to be addressed regarding solution preparation. As shown by these examples, prior to experimentation or chemical analyses, laboratory techniques based on scientific knowledge of solutions can be applied to solutions, often resulting in great improvement in the usefulness of results

  14. Case numbers for a randomized clinical trial of boron neutron capture therapy for Glioblastoma multiforme

    International Nuclear Information System (INIS)

    Boron neutron capture therapy (BNCT) with Na2B12H11SH (BSH) or p-dihydroxyborylphenylalanine (BPA), and with a combination of both, was compared to radiotherapy with temozolomide, and the number of patients required to show statistically significant differences between the treatments was calculated. Whereas arms using BPA require excessive number of patients in each arm, a two-armed clinical trial with BSH and radiotherapy plus temozolomide is feasible. - Highlights: • BNCT of Glioblastoma with BPA is not more effective than RT+TMZ. • BNCT of Glioblastoma with BSH is probably more effective than RT+TMZ. • A clinical trial with patients of class V and an unmethylated MGMT gene should be conducted

  15. Cost-effectiveness of oral cancer screening: results from a cluster randomized controlled trial in India

    Directory of Open Access Journals (Sweden)

    Sujha Subramanian

    2009-03-01

    Full Text Available OBJECTIVE: To evaluate oral cancer screening by visual inspection. METHODS: A cluster randomized controlled trial was initiated in Trivandrum district, Kerala, India. Of 13 population clusters, seven were randomly allocated to three rounds of screening between 1996 and 2004, while standard care was provided in six (control arm. An activity-based approach was employed to calculate costs associated with various components of the screening trial. Information on the resources used and on clinical events in each trial arm was derived from trial databases. Total costs for each cluster were estimated in 2004 United States dollars (US$. The incremental cost per life-year saved was calculated for all eligible individuals and for high-risk individuals (i.e. tobacco or alcohol users. FINDINGS: The proportion of oral cancers detected at an early stage (i.e. stage I or II was higher in the intervention arm than the control arm (42% versus 24%, respectively. The incremental cost per life-year saved was US$ 835 for all individuals eligible for screening and US$ 156 for high-risk individuals. Oral cancer screening by visual inspection was performed for under US$ 6 per person. CONCLUSION: The most cost-effective approach to oral cancer screening by visual inspection is to offer it to the high-risk population. Targeted screening of this group will ensure that screening can be offered at a reasonable cost in a limited-resource setting.

  16. Group Lidcombe Program Treatment for Early Stuttering: A Randomized Controlled Trial

    Science.gov (United States)

    Arnott, Simone; Onslow, Mark; O'Brian, Sue; Packman, Ann; Jones, Mark; Block, Susan

    2014-01-01

    Purpose: This study adds to the Lidcombe Program evidence base by comparing individual and group treatment of preschoolers who stutter. Method: A randomized controlled trial of 54 preschoolers was designed to establish whether group delivery outcomes were not inferior to the individual model. The group arm used a rolling group model, in which a…

  17. Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi

    Directory of Open Access Journals (Sweden)

    Ndebele Paul M

    2012-11-01

    Full Text Available Abstract Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n=124 obtained low scores (lower than 75% on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used daily examples from the field of Agriculture because Malawi has an agro-based economy. Methods The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18 and intervention arms (n=18. The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study. Results The findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75% during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer’s exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001. Conclusions

  18. Overview of the aerial radiological measuring system (ARMS) program

    International Nuclear Information System (INIS)

    Since 1960 EG and G, Inc. has developed and maintained for the U.S. Energy Research and Development Administration (ERDA) a state-of-the-art radiation surveillance program called the Aerial Radiological Measuring System (ARMS). Radiological surveys covering more than 300,000 square miles have been performed. In addition to the radiation detector gear, the system includes an inertial navigation system, radar altimeter, meteorological probes, air sampler, air sample analyzer, multispectral cameras, aerial mapping camera and infrared scanner. The recently improved data acquisition system, REDAR, records all inputs digitally on magnetic tape and is readily mounted in fixed-wing aircraft or helicopters. The data analysis system, REDAC, is mounted in a mobile processing laboratory which accompanies the aircraft on surveys. Radiation isopleth maps, both for gross counts and selected isotopes, can be prepared in the field. Special computer software enables the ARMS to detect changes of less than 1.0 μR/hr in exposure rates between successive surveys of a given site

  19. Dual Arm Work Module Development and Appplications

    Energy Technology Data Exchange (ETDEWEB)

    Noakes, M.W.

    1999-04-25

    The dual arm work module (DAWM) was developed at Oak Ridge National Laboratory (ORNL) by the Robotics Technology Development Program (RTDP) as a development test bed to study issues related to dual arm manipulation, including platform cotilguration, controls, automation, operations, and tooling. The original platform was based on two Schilling Titan II manipulators mounted to a 5-degree-of- freedom (DOF) base fabricated by RedZone Robotics, Inc. The 5-DOF articulation provided a center torso rotation, linear actuation to change the separation between the arms, and arm base rotation joints to provide "elbows up," elbows down," or "elbows out" orientation. A series of tests were conducted on operations, tooling, and task space scene analysis (TSSA)-driven robotics for overhead transporter- mounted and crane hook-deployed scenarios. A concept was developed for DAWM deployment from a large remote work vehicle, but the project was redirected to support dismantlement of the Chicago Pile #5 (CP-5) reactor at Argonne National Laboratory in fiscal year (FY) 1997. Support of CP-5 required a change in focus of the dual arm technology from that of a development test bed to a system focussed for a specific end user. ORNL teamed with the Idaho National Environmental ,Engineering Laboratory, Sandia National Laboratory, and the Savannah River Technology Center to deliver a crane-deployed derivative of the DAWM, designated the dual arm work platform (DAWP). RTDP staff supported DAWP at CP-5 for one FY; Argonne staff continued operation through to dismantlement of the reactor internals. Lessons learned from this interaction were extensive. Beginning in FY 1999, dual arm development activities are again being pursued in the context of those lessons learned. This paper describes the progression of philosophy of the DAWM from initial test bed to lessons learned through interaction at CP-5 and to the present investigation of telerobotic assist of teleoperation and TSSA- driven robotics.

  20. Association between intramuscular fat in the arm following arm training and INSIG2

    DEFF Research Database (Denmark)

    Popadic Gacesa, J Z; Secher, N H; Momcilovic, M; Grujic, N G

    2014-01-01

    ) ; mean ± standard deviation) carried out a 12-week two-arm elbow extensor training (10 maximal extensions with 1 min recovery between bouts) five times per day, five times per week. For 17 volunteers, upper arm muscle and adipose tissue [subcutaneous (SCAT) and intramuscular (IMAT)] volumes were...

  1. Randomized clinical trial comparing sodium picosulfate with mannitol on the preparation FOR colonoscopy in hospitalized patients Ensaio clínico randomizado comparando picosulfato de sódio com manitol no preparo para colonoscopia em pacientes hospitalizados

    Directory of Open Access Journals (Sweden)

    Suzana Müller

    2007-09-01

    Full Text Available BACKGROUND: The cleansing of the colon for a colonoscopy exam must be complete so as to allow the visualization and inspection of the intestinal lumen. The ideal cleansing agent should be easily administered, have a low cost, and minimum collateral effects. Sodium picosulfate together with the magnesium citrate is a cathartic stimulant and mannitol is an osmotic laxative, both usually used for this purpose. AIMS: Assess the colon cleanliness comparing the use of mannitol and sodium picosulfate as well as evaluate the level of patient satisfaction, the presence of foam, pain, and abdominal distension in hospitalized patients undergoing colonoscopy. METHODS: A prospective, randomized, single-blind study with 80 patients that compared two groups: mannitol (40 and sodium picosulfate (40. Both groups received the same dietary orientation. The study was approved by the hospital’s Ethics and Research Committee. The endoscopist was blind to the type of preparation. Outcomes evaluated: level of the colon’s cleanliness, patient’s satisfaction, the presence of foam, abdominal pain and distension, and the duration of the exam. The data was analyzed by means of the chi-squared test for proportions and Mann-Whitney for independent samples. RESULTS: There were no statistically significant differences between the groups in relation to the level of the colon’s cleanliness, patient’s satisfaction, the presence of foam, abdominal pain, and the duration of the exam. Fifteen percent of the exams of the mannitol group were interrupted while from the sodium picosulfate group it was 5%. The presence of foam was similar for both groups. The average duration for carrying out the exam was 28.44 minutes for the mannitol group and 35.59 minutes for the sodium picosulfate group. Abdominal distension was more frequent in the mannitol group. If they would have to do the same exam, the answer was that 80% said yes from the mannitol group and 92.5% from the sodium

  2. A randomised double-blind clinical trial of two yellow fever vaccines prepared with substrains 17DD and 17D-213/77 in children nine-23 months old

    Directory of Open Access Journals (Sweden)

    2015-09-01

    Full Text Available This randomised, double-blind, multicentre study with children nine-23 months old evaluated the immunogenicity of yellow fever (YF vaccines prepared with substrains 17DD and 17D-213/77. YF antibodies were tittered before and 30 or more days after vaccination. Seropositivity and seroconversion were analysed according to the maternal serological status and the collaborating centre. A total of 1,966 children were randomised in the municipalities of the states of Mato Grosso do Sul, Minas Gerais and São Paulo and blood samples were collected from 1,714 mothers. Seropositivity was observed in 78.6% of mothers and 8.9% of children before vaccination. After vaccination, seropositivity rates of 81.9% and 83.2%, seroconversion rates of 84.8% and 85.8% and rates of a four-fold increase over the pre-vaccination titre of 77.6% and 81.8% were observed in the 17D-213/77 and 17DD subgroups, respectively. There was no association with maternal immunity. Among children aged 12 months or older, the seroconversion rates of 69% were associated with concomitant vaccination against measles, mumps and rubella. The data were not conclusive regarding the interference of maternal immunity in the immune response to the YF vaccine, but they suggest interference from other vaccines. The failures in seroconversion after vaccination support the recommendation of a booster dose in children within 10 years of the first dose.

  3. New treatment for nipple soreness in breastfeeding mothers: A clinical trial study

    Directory of Open Access Journals (Sweden)

    Reza Saeidi

    2015-06-01

    Full Text Available Background: A common, early postpartum concern of the breastfeeding mother is nipple pain. Because of a lack of effective treatment and opposing results about lanolin, we decided to compare the effect of lanolin ointment and aloe Vera gel on nipple soreness treatment. Methods: This clinical blind trial was performed in Mashhad, Iran, from February 2008 to May 2009. Sampling was nonrandom and purposive, and then samples were divided randomly into two groups. After first applying the preparation on their arms to check for allergy symptoms, mothers were instructed to then rub the preparation on their nipples three times a day for seven consecutive days, each application performed after feeding the baby. Mothers were to let the preparation dry and not to wash it before the next feeding. Researcher pretreatment at the third and seventh day filled out the Storr scale with interviews and examinations. There were no complications in mothers and infants because of the drug’s usage The data was then analyzed with Spss 11.5 and Mann-Whitney, Student’s t-test, and t-paired tests. Results: A total of 100 samples enrolled with 50 samples in the lanolin group and 50 samples in the aloe vera group. In aloe Vera group Nipple soreness scoring decreased significantly at the third day versus pretreatment (p=0.00 and also at the seventh day versus pretreatment and the third day (p=0.000. Nipple soreness scoring decreased significantly at the third day versus pretreatment (p=0.00 and also at the seventh day versus pretreatment and the third day (p=0.000, p=0.001. The two groups were homogenous at the pretreatment day (p=0.711, but there was a significant difference between the two groups at the third and seventh day (p=0.048, p=0.003. Conclusion: Aloe Vera is more effective than lanolin on nipple soreness healing.

  4. Core Muscle Activation in One-Armed and Two-Armed Kettlebell Swing.

    Science.gov (United States)

    Andersen, Vidar; Fimland, Marius S; Gunnarskog, Aril; Jungård, Georg-Andrè; Slåttland, Roy-Andrè; Vraalsen, Øyvind F; Saeterbakken, Atle H

    2016-05-01

    The aim of the study was to compare the electromyographic activity of rectus abdominis, oblique external, and lower and upper erector spinae at both sides of the truncus in 1-armed and 2-armed kettlebell swing. Sixteen healthy men performed 10 repetitions of both exercises using a 16-kg kettlebell in randomized order. For the upper erector spinae, the activation of the contralateral side during 1-armed swing was 24% greater than that of the ipsilateral side during 1-armed swing (p kettlebell swing with 1 arm resulted in greater neuromuscular activity for the contralateral side of the upper erector spinae and ipsilateral side of the rectus abdominis, and lower activation of the opposite side of the respective muscles. PMID:26473519

  5. ARM Airborne Carbon Measurements (ARM-ACME) and ARM-ACME 2.5 Final Campaign Reports

    Energy Technology Data Exchange (ETDEWEB)

    Biraud, S. C. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Tom, M. S. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Sweeney, C. [NOAA Earth Systems Research Lab., Boulder, CO (United States)

    2016-01-01

    We report on a 5-year multi-institution and multi-agency airborne study of atmospheric composition and carbon cycling at the Atmospheric Radiation Measurement (ARM) Climate Research Facility’s Southern Great Plains (SGP) site, with scientific objectives that are central to the carbon-cycle and radiative-forcing goals of the U.S. Global Change Research Program and the North American Carbon Program (NACP). The goal of these measurements is to improve understanding of 1) the carbon exchange of the Atmospheric Radiation Measurement (ARM) SGP region; 2) how CO2 and associated water and energy fluxes influence radiative-forcing, convective processes, and CO2 concentrations over the ARM SGP region, and 3) how greenhouse gases are transported on continental scales.

  6. Overexpectation and Trial Massing

    OpenAIRE

    Sissons, Heather T.; Miller, Ralph R.

    2009-01-01

    Three experiments were conducted to examine the interaction of overexpectation treatment and trial massing using a Pavlovian fear conditioning procedure with rats. In first-order conditioning, Experiment 1 found the overexpectation effect (i.e., decreased conditioned responding to a cue after compound training when the elements were previously reinforced), the trial spacing effect (i.e., decreased responding to a cue when reinforced trials are massed), and a counteraction between overexpectat...

  7. Compliance in clinical trials.

    OpenAIRE

    Pullar, T; Kumar, S; Feely, M

    1989-01-01

    Compliance with treatment can be an important determinant of the outcome of clinical trials. To date there is no completely satisfactory method of measuring compliance and some of the most widely used methods are inadequate. The various methods of measuring compliance and how they have been applied to clinical trials are described, and improvements in the standard of the measurement and reporting of compliance in clinical trials are suggested.

  8. Aerial measurement of radioactivity in the frame of ARM10 exercise; Aeroradiometrische Messungen im Rahmen der Uebung ARM10

    Energy Technology Data Exchange (ETDEWEB)

    Bucher, B.; Butterweck, G.; Rybach, L.; Schwarz, G.; Mayer, S.

    2011-06-15

    The measurement flights of the exercise ARM10 were performed between 5{sup th} and 8{sup th} of July 2010 under the direction of G. Scharding of the National Emergency Operations Centre (NAZ) and coordination by the Expert Group for Aeroradiometrics (FAR). According to the alternating schedule of the annual ARM exercises, the environs of the nuclear power plants Beznau (KKB) and Leibstadt (KKL) as well as those of the Paul Scherrer Institute (PSI) research facility and of the Intermediate Storage Facility for Nuclear Waste (ZWILAG) were inspected. In cooperation with German authorities the measuring area was extended with a region north of the Rhine river. The values measured over the premises of KKB, KKL, ZWILAG and PSI matched with the results obtained in previous years. On request by the Federal Office of Public Health (FOPH) areas near Posieux, Guettingen, Cadenazzo and Affoltern/ZH were inspected. These locations are intended as reference areas for the radiological surveillance of the environment by FOPH. In preparation of an international intercomparison exercise scheduled for 2011 in the field of in-situ gamma-spectrometry, an area located in the Dischma Valley was measured with airborne gamma-spectrometry. Measuring flights along three profiles supplemented aeroradiometric data in Swiss regions which were not covered before by airborne gamma-spectrometry.(authors)

  9. Spiral Arms as Cosmic Ray Source Distributions

    CERN Document Server

    Werner, M; Strong, A W; Reimer, O

    2014-01-01

    There is evidence that the distribution of suspected cosmic ray sources are associated with the spiral arm structure of galaxies. It is yet not clearly understood what effect such a cosmic ray source distribution has on the particle transport in our Galaxy. We use the PICARD code to perform high-resolution 3D simulations of electrons and protons in galactic propagation scenarios that include four-arm and two-arm logarithmic spiral cosmic ray source distributions with and without a central bar structure as well as the spiral arm configuration of the NE2001 model for the distribution of free electrons in the Milky Way. Results of these simulation are compared to an axisymmetric radial source distribution. Also, effects on the cosmic ray flux and spectra due to different positions of the Earth relative to the spiral structure are studied. We find that high energy electrons are strongly confined to their sources and the obtained spectra largely depend on the Earth's position relative to the spiral arms. Similar f...

  10. Efficacy of two educational interventions about inhalation techniques in patients with chronic obstructive pulmonary disease (COPD. TECEPOC: study protocol for a partially randomized controlled trial (preference trial

    Directory of Open Access Journals (Sweden)

    Leiva-Fernández Francisca

    2012-05-01

    Full Text Available Abstract Background Drugs for inhalation are the cornerstone of therapy in obstructive lung disease. We have observed that up to 75 % of patients do not perform a correct inhalation technique. The inability of patients to correctly use their inhaler device may be a direct consequence of insufficient or poor inhaler technique instruction. The objective of this study is to test the efficacy of two educational interventions to improve the inhalation techniques in patients with Chronic Obstructive Pulmonary Disease (COPD. Methods This study uses both a multicenter patients´ preference trial and a comprehensive cohort design with 495 COPD-diagnosed patients selected by a non-probabilistic method of sampling from seven Primary Care Centers. The participants will be divided into two groups and five arms. The two groups are: 1 the patients´ preference group with two arms and 2 the randomized group with three arms. In the preference group, the two arms correspond to the two educational interventions (Intervention A and Intervention B designed for this study. In the randomized group the three arms comprise: intervention A, intervention B and a control arm. Intervention A is written information (a leaflet describing the correct inhalation techniques. Intervention B is written information about inhalation techniques plus training by an instructor. Every patient in each group will be visited six times during the year of the study at health care center. Discussion Our hypothesis is that the application of two educational interventions in patients with COPD who are treated with inhaled therapy will increase the number of patients who perform a correct inhalation technique by at least 25 %. We will evaluate the effectiveness of these interventions on patient inhalation technique improvement, considering that it will be adequate and feasible within the context of clinical practice. Trial registration Current Controlled Trials ISRTCTN15106246

  11. A method to determine the orientation of the upper arm about its longitudinal axis during dynamic motions.

    Science.gov (United States)

    Gordon, Brian J; Dapena, Jesús

    2013-01-01

    Inaccuracy in determining the orientation of the upper arm about its longitudinal axis (twist orientation) has been a pervasive problem in sport biomechanics research. The purpose of this study was to develop a method to improve the calculation of the upper arm twist orientation in dynamic sports activities. The twist orientation of the upper arm is defined by the orientation of its mediolateral axis. The basis for the new method is that at any angle in the flexion/extension range of an individual's elbow, it is possible to define a true mediolateral axis and also a surrogate mediolateral axis perpendicular to the plane containing the shoulder, elbow and wrist joints. The difference between the twist orientations indicated by these two versions of the mediolateral axis will vary from one elbow angle to another, but if the elbow joint deforms equally in different activities, for any given subject the difference should be constant at any given value of the elbow angle. Application of the new method required individuals to execute sedate elbow extension trials prior to the dynamic trials. Three-dimensional motion analysis of the sedate extension trials allowed quantification of the difference between the true and surrogate mediolateral axes for all angles in the entire flexion/extension range of an individual's elbow. This made it possible to calculate in any dynamic trial the twist orientation defined by the true mediolateral axis from the twist orientation defined by the surrogate mediolateral axis. The method was tested on a wooden model of the arm. PMID:23141956

  12. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    OpenAIRE

    Krämer Jürgen; Knauer Christine; Mansmann Ulrich; Witte Steffen; Streitberger Konrad; Scharf Hanns-Peter; Victor Norbert

    2004-01-01

    Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third co...

  13. Baseline diabetes as a way to predict CV outcomes in a lipid-modifying trial: A meta-analysis of 330,376 patients from 47 landmark studies

    OpenAIRE

    Hermans, Michel; Bouenizabila, Evariste; Amoussou-guenou, Daniel K.; Ahn, Sylvie A; Rousseau, Michel

    2015-01-01

    Background: Diabetes is a major cardiovascular risk factor. However, its influence on the rate of occurrence of cardiovascular (CV) events during a clinical trial that included a diabetes subgroup has not yet been quantified. Aims: To establish equations relating baseline diabetes prevalence and incident CV events, based on comparator arms data of major lipid-modifying trials. Methods: Meta-analysis of primary outcomes (PO) rates of key prospective trials, for which the baseline proportion of...

  14. Fusion of hand and arm gestures

    Science.gov (United States)

    Coquin, D.; Benoit, E.; Sawada, H.; Ionescu, B.

    2005-12-01

    In order to improve the link between an operator and its machine, some human oriented communication systems are now using natural languages like speech or gesture. The goal of this paper is to present a gesture recognition system based on the fusion of measurements issued from different kind of sources. It is necessary to have some sensors that are able to capture at least the position and the orientation of the hand such as Dataglove and a video camera. Datagloge gives a measure of the hand posture and a video camera gives a measure of the general arm gesture which represents the physical and spatial properties of the gesture, and based on the 2D skeleton representation of the arm. The measurements used are partially complementary and partially redundant. The application is distributed on intelligent cooperating sensors. The paper presents the measurement of the hand and the arm gestures, the fusion processes, and the implementation solution.

  15. Chapitre VIII. Le commerce des armes

    OpenAIRE

    Gasteyger, Curt

    2015-01-01

    Si nous ne vendons pas d’armes, quelqu’un d’autre le fera à notre placeUn homme politique américain, soviétique, français ou anglais Une croissance phénoménale Les dépenses d’armement et la taille des forces armées augmentent plus rapidement dans les pays en voie de développement que dans le monde industriel. Pendant la décennie 1973-1982, les armées des pays du Sud se sont accrues de 2 538 000 hommes (la Chine étant comprise), alors que les effectifs de celles du Nord, avec une addition de 3...

  16. Adaptive Control Strategies for Flexible Robotic Arm

    Science.gov (United States)

    Bialasiewicz, Jan T.

    1996-01-01

    The control problem of a flexible robotic arm has been investigated. The control strategies that have been developed have a wide application in approaching the general control problem of flexible space structures. The following control strategies have been developed and evaluated: neural self-tuning control algorithm, neural-network-based fuzzy logic control algorithm, and adaptive pole assignment algorithm. All of the above algorithms have been tested through computer simulation. In addition, the hardware implementation of a computer control system that controls the tip position of a flexible arm clamped on a rigid hub mounted directly on the vertical shaft of a dc motor, has been developed. An adaptive pole assignment algorithm has been applied to suppress vibrations of the described physical model of flexible robotic arm and has been successfully tested using this testbed.

  17. Systems Approach to Arms Control Verification

    Energy Technology Data Exchange (ETDEWEB)

    Allen, K; Neimeyer, I; Listner, C; Stein, G; Chen, C; Dreicer, M

    2015-05-15

    Using the decades of experience of developing concepts and technologies for verifying bilateral and multilateral arms control agreements, a broad conceptual systems approach is being developed that takes into account varying levels of information and risk. The IAEA has already demonstrated the applicability of a systems approach by implementing safeguards at the State level, with acquisition path analysis as the key element. In order to test whether such an approach could also be implemented for arms control verification, an exercise was conducted in November 2014 at the JRC ITU Ispra. Based on the scenario of a hypothetical treaty between two model nuclear weapons states aimed at capping their nuclear arsenals at existing levels, the goal of this exercise was to explore how to use acquisition path analysis in an arms control context. Our contribution will present the scenario, objectives and results of this exercise, and attempt to define future workshops aimed at further developing verification measures that will deter or detect treaty violations.

  18. ARM Cloud Retrieval Ensemble Data Set (ACRED)

    Energy Technology Data Exchange (ETDEWEB)

    Zhao, C; Xie, S; Klein, SA; McCoy, R; Comstock, JM; Delanoë, J; Deng, M; Dunn, M; Hogan, RJ; Jensen, MP; Mace, GG; McFarlane, SA; O’Connor, EJ; Protat, A; Shupe, MD; Turner, D; Wang, Z

    2011-09-12

    This document describes a new Atmospheric Radiation Measurement (ARM) data set, the ARM Cloud Retrieval Ensemble Data Set (ACRED), which is created by assembling nine existing ground-based cloud retrievals of ARM measurements from different cloud retrieval algorithms. The current version of ACRED includes an hourly average of nine ground-based retrievals with vertical resolution of 45 m for 512 layers. The techniques used for the nine cloud retrievals are briefly described in this document. This document also outlines the ACRED data availability, variables, and the nine retrieval products. Technical details about the generation of ACRED, such as the methods used for time average and vertical re-grid, are also provided.

  19. Characterizing spiral arm and interarm star formation

    CERN Document Server

    Kreckel, K; Schinnerer, E; Groves, B; Adamo, A; Hughes, A; Meidt, S

    2016-01-01

    Interarm star formation contributes significantly to a galaxy's star formation budget, and provides an opportunity to study stellar birthplaces unperturbed by spiral arm dynamics. Using optical integral field spectroscopy of the nearby galaxy NGC 628 with VLT/MUSE, we identify 391 HII regions at 35pc resolution over 12 kpc^2. Using tracers sensitive to the underlying gravitational potential, we associate HII regions with either arm (271) or interarm (120) environments. We find that most HII region physical properties (luminosity, size, metallicity, ionization parameter) are independent of environment. We calculate the fraction of Halpha luminosity due to the diffuse ionized gas (DIG) background contaminating each HII region, and find the DIG surface brightness to be higher within HII regions compared to the surroundings, and slightly higher within arm HII regions. Use of the temperature sensitive [SII]/Halpha line ratio map instead of the Halpha surface brightness to identify HII region boundaries does not ch...

  20. Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial

    Directory of Open Access Journals (Sweden)

    Guallar Eliseo

    2010-12-01

    Full Text Available Abstract Background Overweight and obesity are highly prevalent among persons with serious mental illness. These conditions likely contribute to premature cardiovascular disease and a 20 to 30 percent shortened life expectancy in this vulnerable population. Persons with serious mental illness need effective, appropriately tailored behavioral interventions to achieve and maintain weight loss. Psychiatric rehabilitation day programs provide logical intervention settings because mental health consumers often attend regularly and exercise can take place on-site. This paper describes the Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE. The goal of the study is to determine the effectiveness of a behavioral weight loss intervention among persons with serious mental illness that attend psychiatric rehabilitation programs. Participants randomized to the intervention arm of the study are hypothesized to have greater weight loss than the control group. Methods/Design A targeted 320 men and women with serious mental illness and overweight or obesity (body mass index ≥ 25.0 kg/m2 will be recruited from 10 psychiatric rehabilitation programs across Maryland. The core design is a randomized, two-arm, parallel, multi-site clinical trial to compare the effectiveness of an 18-month behavioral weight loss intervention to usual care. Active intervention participants receive weight management sessions and physical activity classes on-site led by study interventionists. The intervention incorporates cognitive adaptations for persons with serious mental illness attending psychiatric rehabilitation programs. The initial intensive intervention period is six months, followed by a twelve-month maintenance period in which trained rehabilitation program staff assume responsibility for delivering parts of the intervention. Primary outcomes are weight loss at six and 18 months. Discussion Evidence-based approaches to the high burden

  1. Offset between stellar spiral arms and gas arms of the Milky Way

    CERN Document Server

    Hou, L G

    2015-01-01

    Spiral arms shown by different components may not be spatially coincident, which can constrain formation mechanisms of spiral structure in a galaxy. We reassess the spiral arm tangency directions in the Milky Way through identifying the bump features in the longitude plots of survey data for infrared stars, radio recombination lines (RRLs), star formation sites, CO, high density regions in clouds, and HI. The bump peaks are taken as indications for arm tangencies, which are close to the real density peaks near the spiral arm tangency point but often have $\\sim$ 1$^\\circ$ offset to the interior of spiral arms. The arm tangencies identified from the longitudes plots for RRLs, HII regions, methanol masers, CO, high density gas regions, and HI gas appear nearly the same Galactic longitude, and therefore there is no obvious offset for spiral arms traced by different gas components. However, we find obvious displacements of 1.3$^\\circ-$ 5.8$^\\circ$ between gaseous bump peaks from the directions of the maximum densi...

  2. A USPL functional system with articulated mirror arm for in-vivo applications in dentistry

    Science.gov (United States)

    Schelle, Florian; Meister, Jörg; Dehn, Claudia; Oehme, Bernd; Bourauel, Christoph; Frentzen, Mathias

    Ultra-short pulsed laser (USPL) systems for dental application have overcome many of their initial disadvantages. However, a problem that has not yet been addressed and solved is the beam delivery into the oral cavity. The functional system that is introduced in this study includes an articulated mirror arm, a scanning system as well as a handpiece, allowing for freehand preparations with ultra-short laser pulses. As laser source an Nd:YVO4 laser is employed, emitting pulses with a duration of tp Laser sources with higher average output powers might be needed in order to reach sufficient preparation speeds.

  3. Simulations of tidally induced spiral arms

    CERN Document Server

    Semczuk, Marcin

    2015-01-01

    The origin of grand design spiral structure in galaxies is still under debate but one of promising scenarios involves tidal interactions. We use N-body simulations to study the evolution of a Milky Way-size galaxy in a Virgo-like cluster. The galaxy is placed on a typical eccentric orbit and evolved for 10 Gyr. We find that grand design spiral arms are triggered by pericenter passages and later on they wind up and dissipate. The arms formed in the simulations are approximately logarithmic, but are also dynamic, transient and recurrent.

  4. The Marriage Market and Tajik Armed Conflict

    OpenAIRE

    Olga Shemyakina

    2009-01-01

    This paper explores the relationship between the 1992-1998 armed conflict in Tajikistan, sex ratios and the age at first marriage for women. The findings suggest that there is substantial and robust negative effect of temporal and regional exposure to armed conflict on entry into their first marriages by females in Tajikistan. Women born in 1975-1983, who lived in the conflict affected areas were about 30 percent less likely to enter marriage than women of the same age from the lesser affecte...

  5. Homosexuality in the Dutch Armed Forces 2006

    OpenAIRE

    Anna Adolfsen; Saskia Keuzenkamp; m.m.v. Linda Mans

    2006-01-01

    Original title: Uniform uit de kast. This study looks at the attitudes of defence personnel to homosexuality. How do members of the military view homosexual colleagues? Can gays and lesbians working in the armed forces be open about their sexual preferences? Do they regard the armed forces as a gay-friendly workplace, or do they have lots of negative experiences? At the request of the State Secretary for Defence, the Netherlands Institute for Social Research/SCP carried out a study on the acc...

  6. Phoenix Deploying its Robotic Arm Elbow

    Science.gov (United States)

    2008-01-01

    This animated gif is compiled of images from Phoenix's Stereo Surface Imager (SSI) taken on Sol 3. It shows the stair-step motion used to unstow the arm from a protective covering called the biobarrier. The last two moves allow the arm to stand straight up. The Phoenix Mission is led by the University of Arizona, Tucson, on behalf of NASA. Project management of the mission is by NASA's Jet Propulsion Laboratory, Pasadena, Calif. Spacecraft development is by Lockheed Martin Space Systems, Denver.

  7. The ARM unpiloted aerospace vehicle (UAV) program

    Energy Technology Data Exchange (ETDEWEB)

    Sowle, D. [Mission Research Corporation, Santa Barbara, CA (United States)

    1995-09-01

    Unmanned aerospace vehicles (UAVs) are an important complement to the DOE`s Atmospheric Radiation Measurement (ARM) Program. ARM is primarily a ground-based program designed to extensively quantify the radiometric and meteorological properties of an atmospheric column. There is a need for airborne measurements of radiative profiles, especially flux at the tropopause, cloud properties, and upper troposphere water vapor. There is also a need for multi-day measurements at the tropopause; for example, in the tropics, at 20 km for over 24 hours. UAVs offer the greatest potential for long endurance at high altitudes and may be less expensive than piloted flights. 2 figs.

  8. Key-hiding on the ARM platform

    OpenAIRE

    NILSSON Alexander; Andersson, Marcus; Axelsson, Stefan

    2014-01-01

    To combat the problem of encryption key recovery from main memory using cold boot-attacks, various solutions has been suggested, but most of these have been implemented on the x86 architecture, which is not prevalent in the smartphone market, where instead ARM dominates. One existing solution does exist for the ARM architecture but it is limited to key sizes of 128 bits due to not being able to utilise the full width of the CPU registers used for key storage. We developed a test-implementatio...

  9. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials ... 000 people. If the U.S. Food and Drug Administration agrees that the trial results are positive, they ...

  10. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P;

    1993-01-01

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

  11. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... can include imaging tests that produce pictures of what is inside the body laboratory tests that check samples of blood, urine, or other body tissues genetic tests that look for genes linked to some types of disease. Diagnostic Trials In diagnostic trials, researchers ...

  12. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical Trial Informed ... for more information Scientists usually do years of experiments in the laboratory and in animals before they even consider testing an experimental treatment ...

  13. The COLOFOL trial

    DEFF Research Database (Denmark)

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

    2016-01-01

    trial, comparing demographic characteristics between randomized patients and eligible patients not included in the study. MATERIALS AND METHODS: COLOFOL was designed as a pragmatic trial with wide inclusion criteria and few exclusion criteria, in order to obtain a sample reflecting the general patient...

  14. Miscanthus production field trials

    Energy Technology Data Exchange (ETDEWEB)

    Jones, B. [University Coll., Dublin (Ireland)

    1993-12-31

    Under the E.C. Joule program in 1989, a European network started on 18 sites a replicated production trial of an asian plant to produce biomass. The trials show that it is possible to successfully establish a Miscanthus crop under a wide range of climatic and edaphic conditions in Europe. Tests and results are presented. (TEC).

  15. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... disease or prevent a disease from returning. Supportive Care Trials In supportive care trials, researchers look for ways to make life ... groups, and various types of social interventions. Supportive care interventions are not intended to treat or cure ...

  16. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P; Christensen, I; Denis, L

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

  17. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical Trial Informed ... years of experiments in the laboratory and in animals before they even ... this early research occurs at universities and medical centers across the ...

  18. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... IV trial for drugs or devices takes place after the U.S. Food and Drug Administration approves their ...

  19. CLINICAL TRIALS.GOV

    Science.gov (United States)

    ClinicalTrials.gov provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The U.S. National Institutes of Health (NIH), through its National Library of Medi...

  20. Trial by Jury in Russian Military Courts

    Directory of Open Access Journals (Sweden)

    Nikolai P. Kovalev

    2008-07-01

    Full Text Available One of peculiar features of the military criminal justice system in Russia is that in some cases military defendants may apply for trial by jury. Unlike the existing U.S. court-martial jury and the Russian military jury of the early 1900s (World War I period which were comprised of the members of the armed forces, in modern Russia jurors trying military defendants are civilians. This article aims to provide a brief history of military jury in Russia and identify issues of independence and impartiality in Russian military courts with participation of lay decision-makers. In particular, the article will analyze two high-profile cases which resulted in acquittals of Russian officers accused of killing several Chechen civilians during counter-terrorist operations in Chechnya.

  1. [Forensic-medical aspects of injuries inflicted by nonlethal arms].

    Science.gov (United States)

    Babakhanian, A R; Babakhanian, R B; Isakov, V D

    2005-01-01

    Special literature (surgical, forensic-medical and criminalistic) is reviewed on classification, mechanisms of a harmful action and characteristics of injuries inflicted by non-lethal arms. Some details of such arms construction and damaging action are given. PMID:16130323

  2. STRUCTURED MOLECULAR GAS REVEALS GALACTIC SPIRAL ARMS

    International Nuclear Information System (INIS)

    We explore the development of structures in molecular gas in the Milky Way by applying the analysis of the brightness distribution function and the brightness distribution index (BDI) in the archival data from the Boston University-Five College Radio Astronomy Observatory 13CO J = 1-0 Galactic Ring Survey. The BDI measures the fractional contribution of spatially confined bright molecular emission over faint emission extended over large areas. This relative quantity is largely independent of the amount of molecular gas and of any conventional, pre-conceived structures, such as cores, clumps, or giant molecular clouds. The structured molecular gas traced by higher BDI is located continuously along the spiral arms in the Milky Way in the longitude-velocity diagram. This clearly indicates that molecular gas changes its structure as it flows through the spiral arms. Although the high-BDI gas generally coincides with H II regions, there is also some high-BDI gas with no/little signature of ongoing star formation. These results support a possible evolutionary sequence in which unstructured, diffuse gas transforms itself into a structured state on encountering the spiral arms, followed by star formation and an eventual return to the unstructured state after the spiral arm passage.

  3. Analytical forms of chaotic spiral arms

    Science.gov (United States)

    Harsoula, M.; Efthymiopoulos, C.; Contopoulos, G.

    2016-07-01

    We develop an analytical theory of chaotic spiral arms in galaxies. This is based on the Moser theory of invariant manifolds around unstable periodic orbits. We apply this theory to the chaotic spiral arms, which start from the neighbourhood of the Lagrangian points L1 and L2 at the end of the bar in a barred-spiral galaxy. The series representing the invariant manifolds starting at the Lagrangian points L1, L2, or unstable periodic orbits around L1 and L2, yield spiral patterns in the configuration space. These series converge in a domain around every Lagrangian point, called `Moser domain', and represent the orbits that constitute the chaotic spiral arms. In fact, these orbits are not only along the invariant manifolds, but also in a domain surrounding the invariant manifolds. We show further that orbits starting outside the Moser domain but close to it converge to the boundary of the Moser domain, which acts as an attractor. These orbits stay for a long time close to the spiral arms before escaping to infinity.

  4. Diversity in the Danish Armed Forces

    DEFF Research Database (Denmark)

    Schaub Jr, Gary John; Pradhan-Blach, Flemming; Larsen, Esben Salling; Larsen, Josefine Kühnel

    with more diverse militaries, such as the United States, Great Britain, and Canada, include recognition of diversity as a societal imperative to sustain the legitimacy of the armed forces, the necessity of systematically collecting and reporting personnel data to guide policy, the necessity of patience...

  5. Clinical applications: Mobile C-arm systems

    International Nuclear Information System (INIS)

    The introduction of the image intensifier opened up new perspectives in surgery and interventional radiology. This article traces the development of mobile C-arm systems from the first surgical systems to modern systems such as the BV Pulsera with 3D rotational imaging. (orig.)

  6. Verification and transparency in future arms control

    Energy Technology Data Exchange (ETDEWEB)

    Pilat, J.F.

    1996-09-01

    Verification`s importance has changed dramatically over time, although it always has been in the forefront of arms control. The goals and measures of verification and the criteria for success have changed with the times as well, reflecting such factors as the centrality of the prospective agreement to East-West relations during the Cold War, the state of relations between the United States and the Soviet Union, and the technologies available for monitoring. Verification`s role may be declining in the post-Cold War period. The prospects for such a development will depend, first and foremost, on the high costs of traditional arms control, especially those associated with requirements for verification. Moreover, the growing interest in informal, or non-negotiated arms control does not allow for verification provisions by the very nature of these arrangements. Multilateral agreements are also becoming more prominent and argue against highly effective verification measures, in part because of fears of promoting proliferation by opening sensitive facilities to inspectors from potential proliferant states. As a result, it is likely that transparency and confidence-building measures will achieve greater prominence, both as supplements to and substitutes for traditional verification. Such measures are not panaceas and do not offer all that we came to expect from verification during the Cold war. But they may be the best possible means to deal with current problems of arms reductions and restraints at acceptable levels of expenditure.

  7. Long arm decompression osteotomy for hallux limitus.

    Science.gov (United States)

    Robinson, Stephen C; Frank, Ryan P

    2005-04-01

    This article presents a new osteotomy for stage I or II hallux limitus. The long arm decompression osteotomy can be used to shorten and plantarflex the first metatarsal. The indications, surgical technique, advantages, and disadvantages are described in detail. PMID:15833423

  8. Molecular machines: Molecules bearing robotic arms

    Science.gov (United States)

    Aprahamian, Ivan

    2016-02-01

    Mass production at the nanoscale requires molecular machines that can control, with high fidelity, the spatial orientation of other reactive species. The demonstration of a synthetic system in which a molecular robotic arm can be used to manipulate the position of a chemical cargo is a significant step towards achieving this goal.

  9. 49 CFR 236.702 - Arm, semaphore.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Arm, semaphore. 236.702 Section 236.702 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION..., MAINTENANCE, AND REPAIR OF SIGNAL AND TRAIN CONTROL SYSTEMS, DEVICES, AND APPLIANCES Definitions § 236.702...

  10. Light duty utility arm software requirements specification

    Energy Technology Data Exchange (ETDEWEB)

    Kiebel, G.R.

    1995-12-18

    This document defines the software requirements for the integrated control and data acquisition system of the Light Duty Utility Arm (LDUA) System. It is intended to be used to guide the design of the application software, to be a basis for assessing the application software design, and to establish what is to be tested in the finished application software product.

  11. Well ARMed and FiRM

    DEFF Research Database (Denmark)

    Rasmussen, Kourosh Marjani; Zenios, Stavros A.

    2007-01-01

    diversification of mortgage loans of a homeowner and apply it to data from the Danish market. Even in the presence of mortgage origination costs it is shown that most risk averse homeowners will do well to consider a diversified portfolio of both fixed (FRM) and adjustable (ARM) rate mortgages. This is...

  12. Arms and the man - or child

    International Nuclear Information System (INIS)

    After almost half a century of remote technology research the telerobotic arm is still less dexterous than the nuclear industry might wish. The authors review R and D in this area of man-machine interfacing, and take a look down the road ahead. (author)

  13. Light duty utility arm software requirements specification

    International Nuclear Information System (INIS)

    This document defines the software requirements for the integrated control and data acquisition system of the Light Duty Utility Arm (LDUA) System. It is intended to be used to guide the design of the application software, to be a basis for assessing the application software design, and to establish what is to be tested in the finished application software product

  14. The extended arm of health professionals?

    DEFF Research Database (Denmark)

    Norlyk, Annelise; Martinsen, Bente

    2013-01-01

    responsibility for both the patient's well-being and for the patient's compliance with the daily regimen. Relatives were caught in a conflicting double role. They were the extended arm of the health professionals but also the caring, supporting partner. A tension arose between relatives' desire to help...

  15. Automation Using Robotic Arm in Rotor Packaging

    Directory of Open Access Journals (Sweden)

    GOPU G.

    2013-03-01

    Full Text Available Till date automation in small and medium scale industries has not enjoyed the same rate of growth as in other information technology sectors, lagging significantly behind automation in large batch production .The use of LabVIEW interfaced with micro-controller in controlling a robotic arm is a latest technique which is being implemented in this project. In medium scale industries packaging of rotors is done manually. This Process is time consuming and also requires manpower. Through this project our efforts are to increase the efficiency by building an automated system which would employ and also reduces manpower. It involves the use of a robotic arm which would identify the rotors positioning, pick it and then place it in the desired location. With the use of this system the process of packaging can be done effectively without any manpower and also does not require constant monitoring and guidance. The DC gear motors are used in actuating the robotic arm. Electromagnetic gripper is employed at the end of the arm which picks and places the helical rotor of weight 1.5 kg in the desired position for packaging and this mechanism is automated and controlled using LabVIEW. The complete set up is compact and versatile.

  16. Watchdog for ARM Radar Network Operations

    Energy Technology Data Exchange (ETDEWEB)

    2016-07-28

    WARNO is a software system designed to monitor the radars in the ARM Radar Network. It allows real time monitoring and tracking of instrument state and condition. It provides a web portal on the front end to interact with users, a REST API webpoint for interactions with third party systems, and an internal distributed architecture to allow it to be deployed at multiple sites.

  17. Light Duty Utility Arm Software Test Plan

    International Nuclear Information System (INIS)

    This plan describes how validation testing of the software will be implemented for the integrated control and data acquisition system of the Light Duty Utility Arm System (LDUA). The purpose of LDUA software validation testing is to demonstrate and document that the LDUA software meets its software requirements specification

  18. Dynamics of Non-steady Spiral Arms in Disk Galaxies

    Science.gov (United States)

    Baba, Junichi; Saitoh, Takayuki R.; Wada, Keiichi

    2013-01-01

    In order to understand the physical mechanisms underlying non-steady stellar spiral arms in disk galaxies, we analyzed the growing and damping phases of their spiral arms using three-dimensional N-body simulations. We confirmed that the spiral arms are formed due to a swing amplification mechanism that reinforces density enhancement as a seeded wake. In the damping phase, the Coriolis force exerted on a portion of the arm surpasses the gravitational force that acts to shrink the portion. Consequently, the stars in the portion escape from the arm, and subsequently they form a new arm at a different location. The time-dependent nature of the spiral arms originates in the continual repetition of this nonlinear phenomenon. Since a spiral arm does not rigidly rotate, but follows the galactic differential rotation, the stars in the arm rotate at almost the same rate as the arm. In other words, every single position in the arm can be regarded as the corotation point. Due to interaction with their host arms, the energy and angular momentum of the stars change, thereby causing radial migration of the stars. During this process, the kinetic energy of random motion (random energy) of the stars does not significantly increase, and the disk remains dynamically cold. Owing to this low degree of disk heating, short-lived spiral arms can recurrently develop over many rotational periods. The resultant structure of the spiral arms in the N-body simulations is consistent with the observational nature of spiral galaxies. We conclude that the formation and structure of spiral arms in isolated disk galaxies can be reasonably understood by nonlinear interactions between a spiral arm and its constituent stars.

  19. DYNAMICS OF NON-STEADY SPIRAL ARMS IN DISK GALAXIES

    International Nuclear Information System (INIS)

    In order to understand the physical mechanisms underlying non-steady stellar spiral arms in disk galaxies, we analyzed the growing and damping phases of their spiral arms using three-dimensional N-body simulations. We confirmed that the spiral arms are formed due to a swing amplification mechanism that reinforces density enhancement as a seeded wake. In the damping phase, the Coriolis force exerted on a portion of the arm surpasses the gravitational force that acts to shrink the portion. Consequently, the stars in the portion escape from the arm, and subsequently they form a new arm at a different location. The time-dependent nature of the spiral arms originates in the continual repetition of this nonlinear phenomenon. Since a spiral arm does not rigidly rotate, but follows the galactic differential rotation, the stars in the arm rotate at almost the same rate as the arm. In other words, every single position in the arm can be regarded as the corotation point. Due to interaction with their host arms, the energy and angular momentum of the stars change, thereby causing radial migration of the stars. During this process, the kinetic energy of random motion (random energy) of the stars does not significantly increase, and the disk remains dynamically cold. Owing to this low degree of disk heating, short-lived spiral arms can recurrently develop over many rotational periods. The resultant structure of the spiral arms in the N-body simulations is consistent with the observational nature of spiral galaxies. We conclude that the formation and structure of spiral arms in isolated disk galaxies can be reasonably understood by nonlinear interactions between a spiral arm and its constituent stars.

  20. Nonproliferation and arms control assessment of weapons-usable fissile material storage and excess plutonium disposition alternatives

    International Nuclear Information System (INIS)

    This report has been prepared by the Department of Energy's Office of Arms Control and Nonproliferation (DOE-NN) with support from the Office of Fissile Materials Disposition (DOE-MD). Its purpose is to analyze the nonproliferation and arms reduction implications of the alternatives for storage of plutonium and HEU, and disposition of excess plutonium, to aid policymakers and the public in making final decisions. While this assessment describes the benefits and risks associated with each option, it does not attempt to rank order the options or choose which ones are best. It does, however, identify steps which could maximize the benefits and mitigate any vulnerabilities of the various alternatives under consideration

  1. Fundamentals of clinical trials

    CERN Document Server

    Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

    2015-01-01

    This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

  2. Radioprotective preparation

    International Nuclear Information System (INIS)

    The invention is intended for radiation injuries prophylaxis in mammals. It has an well expressed radioprotective effect against acute gamma irradiation on cellular level as well as a prolonged action when applied up to 48 hours before the acute irradiation. The preparation is a coprecipitate of the natural tripeptide glutathione (reduced form) and polyvinyl pyrrolidone (pvp) in ratio 30-60/70-40. It is obtained by incubation method with subsequent lyophilization from water solution of the initial components. The molecular mass of the pvp is 20 till 360.103. 2 claims

  3. Effects of Study Design and Allocation on participant behaviour - ESDA: study protocol for a randomized controlled trial

    OpenAIRE

    Sheeran Paschal; Attia John; Wilson Amanda; McCambridge Jim; Kypri Kypros; Bowe Steve; Vater Tina

    2011-01-01

    Abstract Background What study participants think about the nature of a study has been hypothesised to affect subsequent behaviour and to potentially bias study findings. In this trial we examine the impact of awareness of study design and allocation on participant drinking behaviour. Methods/Design A three-arm parallel group randomised controlled trial design will be used. All recruitment, screening, randomisation, and follow-up will be conducted on-line among university students. Participan...

  4. Memantine Improves Attentional Processes in Fragile X-Associated Tremor/Ataxia Syndrome: Electrophysiological Evidence from a Randomized Controlled Trial

    OpenAIRE

    Jin-Chen Yang; Annette Rodriguez; Ashley Royston; Yu-Qiong Niu; Merve Avar; Ryan Brill; Christa Simon; Jim Grigsby; HAGERMAN, RANDI J; Olichney, John M.

    2016-01-01

    Progressive cognitive deficits are common in patients with fragile X-associated tremor/ataxia syndrome (FXTAS), with no targeted treatment yet established. In this substudy of the first randomized controlled trial for FXTAS, we examined the effects of NMDA antagonist memantine on attention and working memory. Data were analyzed for patients (24 in each arm) who completed both the primary memantine trial and two EEG recordings (at baseline and follow-up) using an auditory “oddball” task. Resul...

  5. 78 FR 26326 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2013-05-06

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Department of Defense, Defense Security... a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section...)(1) of the Arms Export Control Act, as amended (i) Prospective Purchaser: United Kingdom (ii)...

  6. 76 FR 60457 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2011-09-29

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Defense Security Cooperation Agency... of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of... Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1)of the Arms Export Control Act...

  7. 32 CFR 552.118 - Issuance from unit arms room.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Issuance from unit arms room. 552.118 Section 552... AND NATIONAL CEMETERIES REGULATIONS AFFECTING MILITARY RESERVATIONS Physical Security of Arms, Ammunition, and Explosives-Fort Lewis, Washington § 552.118 Issuance from unit arms room. When...

  8. 32 CFR 707.3 - Yard arm signaling lights.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 5 2010-07-01 2010-07-01 false Yard arm signaling lights. 707.3 Section 707.3... RESPECT TO ADDITIONAL STATION AND SIGNAL LIGHTS § 707.3 Yard arm signaling lights. Naval vessels may display, as a means of visual signaling, white all round lights at the ends of the yard arms. These...

  9. 77 FR 46417 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2012-08-03

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Department of Defense, Defense Security... a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section... Section 36(b)(1) Of the Arms Export Control Act, as amended (i) Prospective Purchaser: Thailand (ii)...

  10. 49 CFR 173.171 - Smokeless powder for small arms.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Smokeless powder for small arms. 173.171 Section 173.171 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS... Class 7 § 173.171 Smokeless powder for small arms. Smokeless powder for small arms which has...

  11. 77 FR 42707 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2012-07-20

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Defense Security Cooperation Agency... of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of... Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as amended (i)...

  12. 76 FR 60467 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2011-09-29

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Defense Security Cooperation Agency... of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of... Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act (i) Prospective...

  13. 78 FR 62588 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2013-10-22

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Defense Security Cooperation Agency... of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of... Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as amended (i)...

  14. 49 CFR 236.810 - Spectacle, semaphore arm.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Spectacle, semaphore arm. 236.810 Section 236.810 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... Spectacle, semaphore arm. That part of a semaphore arm which holds the roundels and to which the blade...

  15. 76 FR 60471 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2011-09-29

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Department of Defense, Defense Security... a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section... Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act,...

  16. 78 FR 62600 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2013-10-22

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Defense Security Cooperation Agency... of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of... Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act,...

  17. 33 CFR 127.1102 - Transfer hoses and loading arms.

    Science.gov (United States)

    2010-07-01

    ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Transfer hoses and loading arms... Transfer hoses and loading arms. (a) Each hose within the marine transfer area for LHG used for the... arm used for the transfer of LHG or its vapor must— (1) Be made of materials resistant to each...

  18. 78 FR 15004 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2013-03-08

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Defense Security Cooperation Agency... of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of... Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act,...

  19. 78 FR 46579 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2013-08-01

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Department of Defense, Defense Security... a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section... Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as Amended (i)...

  20. 77 FR 37879 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2012-06-25

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Department of Defense, Defense Security... a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section... Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act,...

  1. 48 CFR 908.7111 - Arms and ammunition.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Arms and ammunition. 908... ACQUISITION PLANNING REQUIRED SOURCES OF SUPPLIES AND SERVICES Acquisition of Special Items 908.7111 Arms and ammunition. Pursuant to 10 U.S.C. 4655, the Secretary of the Army is authorized to furnish arms,...

  2. 78 FR 50047 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2013-08-16

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Defense Security Cooperation Agency... of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of... Letter of Offer Pursuant to Section 36(b) (1) Of the Arms Export Control Act, as amended (i)...

  3. 77 FR 51780 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2012-08-27

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Department of Defense, Defense Security... a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section... Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as amended (i)...

  4. 77 FR 42711 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2012-07-20

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Department of Defense, Defense Security... a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section... Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as Amended (i)...

  5. 76 FR 76954 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2011-12-09

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Department of Defense, Defense Security... a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section... Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act,...

  6. 78 FR 72066 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2013-12-02

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Department of Defense, Defense Security... a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section... Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act,...

  7. 48 CFR 225.7702 - Acquisition of small arms.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Acquisition of small arms... Operations in Iraq or Afghanistan 225.7702 Acquisition of small arms. (a) Except as provided in paragraph (b) of this section, when acquiring small arms for assistance to the Army of Iraq, the Army...

  8. 77 FR 75617 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2012-12-21

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Defense Security Cooperation Agency... of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of... Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act,...

  9. 76 FR 56181 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2011-09-12

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Department of Defense, Defense Security... a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section... Section 36(b)(1) of the Arms Export Control Act, as amended (i) Prospective Purchaser: Peru (ii)...

  10. 76 FR 77809 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2011-12-14

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Defense Security Cooperation Agency... of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of... Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as Amended (i)...

  11. 78 FR 701 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2013-01-04

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Defense Security Cooperation Agency... of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of... Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as amended (i)...

  12. 76 FR 60455 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2011-09-29

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Department of Defense, Defense Security... a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section... Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act,...

  13. 77 FR 37881 - 36(b)(1) Arms Sales Notification

    Science.gov (United States)

    2012-06-25

    ... of the Secretary 36(b)(1) Arms Sales Notification AGENCY: Department of Defense, Defense Security... of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of... Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act,...

  14. Dynamics of Non-Steady Spiral Arms in Disk Galaxies

    CERN Document Server

    Baba, Junichi; Wada, Keiichi

    2012-01-01

    In order to understand the physical mechanisms underlying non-steady stellar spiral arms in disk galaxies, we analyzed the growing and damping phases of their spiral arms using three-dimensional $N$-body simulations. We confirmed that the spiral arms are formed due to a swing amplification mechanism that reinforces density enhancement as a seeded wake. In the damping phase, the Coriolis force exerted on a portion of the arm surpasses the gravitational force that acts to shrink the portion. Consequently, the stars in the portion escape from the arm, and subsequently they form a new arm at a different location. The time-dependent nature of the spiral arms are originated in the continual repetition of this non-linear phenomenon. Since a spiral arm does not rigidly rotate, but follows the galactic differential rotation, the stars in the arm rotate at almost the same rate as the arm. In other words, every single position in the arm can be regarded as the co-rotation point. Due to interaction with their host arms, ...

  15. Design of a Dynamic Arm Support (DAS) for gravity compensation

    NARCIS (Netherlands)

    Kramer, Gijs; Römer, GertWillem R.B.E.; Stuyt, Harry J.A.

    2007-01-01

    The Dynamic Arm Support, or briefly the Das, is a new medical device that serves to compensate for lost arm function of the severely disabled. The target group suffers from insufficient muscle force to move its arms over the usual Range of Motion (RoM). The purpose of the Das is to assist its user d

  16. Effectiveness of Provider and Community Interventions to Improve Treatment of Uncomplicated Malaria in Nigeria: A Cluster Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Obinna Onwujekwe

    Full Text Available The World Health Organization recommends that malaria be confirmed by parasitological diagnosis before treatment using Artemisinin-based Combination Therapy (ACT. Despite this, many health workers in malaria endemic countries continue to diagnose malaria based on symptoms alone. This study evaluates interventions to help bridge this gap between guidelines and provider practice. A stratified cluster-randomized trial in 42 communities in Enugu state compared 3 scenarios: Rapid Diagnostic Tests (RDTs with basic instruction (control; RDTs with provider training (provider arm; and RDTs with provider training plus a school-based community intervention (provider-school arm. The primary outcome was the proportion of patients treated according to guidelines, a composite indicator requiring patients to be tested for malaria and given treatment consistent with the test result. The primary outcome was evaluated among 4946 (93% of the 5311 patients invited to participate. A total of 40 communities (12 in control, 14 per intervention arm were included in the analysis. There was no evidence of differences between the three arms in terms of our composite indicator (p = 0.36: stratified risk difference was 14% (95% CI -8.3%, 35.8%; p = 0.26 in the provider arm and 1% (95% CI -21.1%, 22.9%; p = 0.19 in the provider-school arm, compared with control. The level of testing was low across all arms (34% in control; 48% provider arm; 37% provider-school arm; p = 0.47. Presumptive treatment of uncomplicated malaria remains an ingrained behaviour that is difficult to change. With or without extensive supporting interventions, levels of testing in this study remained critically low. Governments and researchers must continue to explore alternative ways of encouraging providers to deliver appropriate treatment and avoid the misuse of valuable medicines.ClinicalTrials.gov NCT01350752.

  17. Trial manufacture of x-band accelerator disks

    International Nuclear Information System (INIS)

    In the X-band accelerator scheme of future linear colliders with normal conductor technology, major issue was the mass production of accelerator structures and microwave transmission devices with ultrahigh precision. Hitachi Ltd. has a technology of ultrahigh precision machining of soft metals, and made trial manufacturing of accelerator disks with ultrahigh precision during half a year from the spring of 2004 based on the blueprint prepared by KEK. The results of this trial are reported. (K.Y.)

  18. The Home-Based Older People's Exercise (HOPE trial: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Forster Anne

    2011-06-01

    Full Text Available Abstract Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE trial is a two arm, assessor blind pilot randomised controlled trial (RCT to assess the effectiveness of a 12 week exercise intervention (the HOPE programme designed to improve the mobility and functional abilities of frail older people living at home, compared with usual care. The primary outcome is the timed-up-and-go test (TUGT, measured at baseline and 14 weeks post-randomisation. Secondary outcomes include the Barthel Index of activities of daily living (ADL, EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D quality of life measure and the geriatric depression scale (GDS, measured at baseline and 14 weeks post-randomisation. We will record baseline frailty using the Edmonton Frail Scale (EFS, record falls and document muscle/joint pain. We will test the feasibility of collection of data to identify therapy resources required for delivery of the intervention. Discussion The HOPE trial will explore and evaluate a home-based exercise intervention for frail older people. Although previous RCTs have used operationalised, non-validated methods of measuring frailty, the HOPE trial is, to our knowledge, the first RCT of an exercise intervention for frail older people that includes a validated method of frailty assessment at baseline. Trial registration ISRCTN: ISRCTN57066881

  19. Embedded ARM Control Robotic Arm using BoaWeb server – a Survey

    Directory of Open Access Journals (Sweden)

    V.Sirisha

    2015-10-01

    Full Text Available In today’s market, the competing microprocessors are ARM (Advanced Risc Microprocessor, Intel, AMD. ARM is preferred since it has been powering portable devices for decades and has simple architecture to keep the energy waste to be minimum. The electronics advancements and embedded technology advancements have become a challenging field in today’s techno world. In paper, the diligent features of embedded systems are introduced. It deals about how a robot is controlled using embedded operating system and ARM. Based on the combination of ARM, DSP and ARM Linux, the robot is controlled. The paper introduces development of embedded robot control system using Wi-Fi and also IOT. The embedded control system design includes four aspects. i.e., system structure, functions, hardware design and software design. By using these aspects (hardware and software adjustments, many robotic applications can be developed. Due to the fast execution speed and reasonable Ethernet speed in ARM processor, this system can be used in industrial oriented applications where there is very much necessity of safety and security.

  20. Bacteriemia during endodontic treatment in relation to the technique of biomechanical preparation: randomized clinical trial Bacteriemia durante o tratamento endodôntico em função da técnica de preparo biomecânico: ensaio clínico randomizado

    Directory of Open Access Journals (Sweden)

    Adriane Tenório Dourado

    2005-12-01

    Full Text Available OBJECTIVE: The aim of this randomized clinical trial was to evaluate the frequency of bacteriemia during endodontic treatment, with comparison between two techniques for biomechanical preparation of the root canal system. MATERIALS AND METHODS: The sample comprised 50 patients aged 16 to 52 years, of both genders, which were divided into 2 groups with 25 patients each. Group I underwent biomechanical preparation by the step-back technique, and Group II was treated by the rotary technique with nickel-titanium instruments (K3. Patients were submitted to antisepsis of the oral cavity with chlorhexidine digluconate and three samples of blood were collected for blood culture: preoperatively, immediately after the biomechanical preparation and 10 minutes later. The significance level adopted was 5.0%, and analysis was performed by descriptive and inferential statistics by means of the Fisher's exact test, Fisher-Freeman-Halton test and Student's t test. Data were analyzed on the Statexact and SPSS softwares. RESULTS: All blood cultures achieved before and immediately after preparation were negative. On the other hand, with regard to the blood cultures collected 10 minutes after preparation, one (4% positive case was found for Group I. However, this difference was not statistically significant (p = 0.50. CONCLUSION: The frequency of bacteriemia was low and observed just for Group I.OBJETIVO: O objetivo deste ensaio clínico randomizado foi avaliar a freqüência de bacteriemia durante o tratamento endodôntico comparando duas técnicas de preparo biomecânico do sistema de canais radiculares. MATERIAIS E MÉTODOS: A amostra constou de 50 pacientes, com idade variando entre 16 e 52 anos e de ambos os sexos, sendo dividida em 2 grupos de 25 pacientes. No Grupo I, realizou-se o preparo biomecânico através da técnica escalonada com recuo progressivo programado, e, no Grupo II, por meio técnica rotatória, empregando instrumentos de níquel-titânio (K3

  1. Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT

    Directory of Open Access Journals (Sweden)

    Huisjes Anjoke JM

    2007-07-01

    Full Text Available Abstract Background Around 80% of intrauterine growth restricted (IUGR infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term. Methods/design The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ. Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term. The study aims to include 325 patients per arm. Discussion This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term. Trial registration Dutch Trial Register and ISRCTN

  2. Randomization in substance abuse clinical trials

    Directory of Open Access Journals (Sweden)

    Woolson Robert F

    2006-02-01

    Full Text Available Abstract Background A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distributions. Numerous randomization techniques, each with varying properties of randomness and balance, are suggested in the statistical literature. This paper reviews common randomization techniques often used in substance abuse research and an application from a National Institute on Drug Abuse (NIDA-funded clinical trial in substance abuse is used to illustrate several choices an investigator faces when designing a clinical trial. Results Comparisons and contrasts of randomization schemes are provided with respect to deterministic and balancing properties. Specifically, Monte Carlo simulation is used to explore the balancing nature of randomization techniques for moderately sized clinical trials. Results demonstrate large treatment imbalance for complete randomization with less imbalance for the urn or adaptive scheme. The urn and adaptive randomization methods display smaller treatment imbalance as demonstrated by the low variability of treatment allocation imbalance. For all randomization schemes, covariate imbalance between treatment arms was small with little variation between adaptive schemes, stratified schemes and unstratified schemes given that sample sizes were moderate to large. Conclusion We develop this paper with the goal of reminding substance abuse researchers of the broad array of randomization options available for clinical trial designs. There may be too quick a tendency for substance abuse researchers to implement the fashionable urn

  3. Motor commands for fast point-to-point arm movements are customized for small changes in inertial load.

    Science.gov (United States)

    Pinter, Ilona J; Bobbert, Maarten F; van Soest, A J Knoek; Smeets, Jeroen B J

    2011-12-01

    For repeated point-to-point arm movements it is often assumed that motor commands are customized in a trial-to-trial manner, based on previous endpoint error. To test this assumption, we perturbed movement execution without affecting the endpoint error by using a modest manipulation of inertia. Participants made point-to-point elbow flexion and extension movements in the horizontal plane, under the instruction to move as fast as possible from one target area to another. In selected trials the moment of inertia of the lower arm was increased or decreased by 25%. First, we found that an unexpected increase or decrease of inertia did not affect the open loop controlled part of the movement path (and thus endpoint error was not affected). Second, we found that when the increased or decreased inertia was presented repeatedly, after 5-11 trials motor commands were customized: the first 100ms of agonistic muscle activity in the smoothed and rectified electromyographic signal of agonistic muscles was higher for the high inertia compared to the low inertia. We conclude that endpoint error is not the only parameter that is used to evaluate if motor commands lead to movements as planned. PMID:21890379

  4. Validation of Heart Failure Events in the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT Participants Assigned to Doxazosin and Chlorthalidone

    Directory of Open Access Journals (Sweden)

    Leenen Frans HH

    2002-11-01

    Full Text Available Abstract Background The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT is a randomized, double-blind, active-controlled trial designed to compare the rate of coronary heart disease events in high-risk hypertensive participants initially randomized to a diuretic (chlorthalidone versus each of three alternative antihypertensive drugs: alpha-adrenergic blocker (doxazosin, ACE-inhibitor (lisinopril, and calcium-channel blocker (amlodipine. Combined cardiovascular disease risk was significantly increased in the doxazosin arm compared to the chlorthalidone arm (RR 1.25; 95% CI, 1.17–1.33; P P Methods and Results Baseline characteristics (age, race, sex, blood pressure did not differ significantly between treatment groups (P P = 0.83. Conclusion Results of the validation process supported findings of increased heart failure in the ALLHAT doxazosin treatment arm compared to the chlorthalidone treatment arm.

  5. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or prevent a disease. A clinical trial may compare experimental products or tests to those already available or may compare existing ...

  6. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... out if an experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or ... specific medical problem. These trials find out if lifestyle changes, such as exercising more, getting more sleep, ...

  7. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... radiotherapy. Click for more information Scientists usually do years of experiments in the laboratory and in animals ... term side effects. This phase can last several years. A Phase III trial gathers more information about ...

  8. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Drug Administration typically requires Phase 1, 2 and 3 trials to be conducted to determine if the ... subjects usually ranges from several hundred to about 3,000 people. If the U.S. Food and Drug ...

  9. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

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

    2015-01-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For eac...

  10. Clinical Trial Basics

    Science.gov (United States)

    ... Human Services Search the NIH Website NIH Employee Intranet Staff Directory En Español Site Menu Home Health ... am thinking about participating? Xsandra/iStock Risks and benefits Clinical trials involve risks, just as routine medical ...

  11. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... was provided by the National Library of Medicine Topic last reviewed: December 2013 For an enhanced version of this page please turn Javascript on. Participating in Clinical Trials ...

  12. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... ways of finding a disease before symptoms occur. These methods, often called screening tests, can include imaging ... getting a disease or a specific medical problem. These trials find out if lifestyle changes, such as ...

  13. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Researchers may study the role of caregivers, support groups, and various types of social interventions. Supportive care ... trial tests an experimental treatment on a small group of often healthy people (20 to 80), to ...

  14. ClinicalTrials.gov

    Data.gov (United States)

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

  15. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Learn More Participating in Clinical Trials Videos quiz yourself MedlinePlus for More Information National Institute on Aging Related Topics Talking with Your Doctor Taking Medicines The information in ...

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... in this topic was provided by the National Library of Medicine Topic last reviewed: December 2013 For ... on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials ...

  17. Polyp Prevention Trial

    Science.gov (United States)

    The primary objective of the Polyp Prevention Trial (PPT) is to determine whether a low fat, high fiber, high vegetable and fruit eating plan will decrease the recurrence of adenomatous polyps of the large bowel.

  18. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials Videos quiz yourself MedlinePlus for More Information National Institute on Aging Related Topics Talking with Your Doctor Taking Medicines The information in this topic was provided by the National ...

  19. A Global Obstacle-avoidance Map for Anthropomorphic Arms

    Directory of Open Access Journals (Sweden)

    Cheng Fang

    2014-07-01

    Full Text Available More and more humanoid robots are used in human society, and they face a wide variety of complicated manipulation tasks, which are mainly to be achieved by their anthropomorphic arms. Obstacle avoidance for the anthropomorphic arm must be a fundamental consideration to guarantee the successful implementation of these tasks. Different from traditional methods searching for feasible or optimal collision-free solutions for the anthropomorphic arm, a global obstacle- avoidance map for the whole arm is proposed to indicate the complete set of feasible solutions. In this map, the motion of the arm can be appropriately planned to intuitively control the configuration of the arm in motion. First, the cubic spline function is adopted to interpolate some well-chosen path points to generate a smooth collision-free path for the wrist of the anthropomorphic arm. Second, based on the path function of the wrist, the time and the self-rotation angle of the arm about the “shoulder-wrist” axis are used to parameterize all possible configurations of the arm so that a global two- dimensional map considering the obstacle avoidance can be established. Subsequently, a collision-free self-rotation angle profile of the arm can be well planned. Finally, the joint trajectories of a specific anthropomorphic arm, which correspond to the planned path of the wrist and self-rotation angle profile of the arm, can be solved on the basis of the general kinematic analysis of the anthropomorphic arm, and the specific structure. Several simulations are conducted to verify that the proposed collision-free motion planning method for anthropomorphic arms has some advantages and can be regarded as a convenient and intuitive tool to control the configuration of the anthropomorphic arm in motion, without collision with obstacles in its surroundings.

  20. Potential Risks and Mitigation Strategies Before the Conduct of a Clinical Trial: An Industry Perspective.

    Science.gov (United States)

    Bhagat, Seema; Kapatkar, Vaibhavi K; Mourya, Meenakshi; Roy, Sucheta; Jha, Shailendra; Reddy, Rajasekhar; Kadhe, Ganesh; Mane, Amey; Sawant, Sandesh

    2016-01-01

    Conduct of clinical trials has undergone substantial changes over the last two decades. Newer markets, evolving guidelines and documentation and high cost involved in conducting the trials have led pharmaceutical companies to prepare a risk mitigation plan. Extensive monitoring of potential risks is an essential element of clinical trials which helps to ensure quality and integrity of a clinical investigation. Every clinical trial has pre (before the trial), conduct and post phase. This article which has been developed as a result of extensive research at ground level by a reputed pharmaceutical company to identify the potential stages of risks that could affect the overall quality and safety of a trial and its outcome during the pre-phase of trial (the stage of the trial where the study design is being planned before initiation of the clinical trial). It includes risks associated with basic study concept, protocol design, Confidential Disclosure Agreement (CDA) and Clinical Trial Authorization (CTA) application signing, vendors of central drug laboratory, site and investigator selection, Clinical Research Coordinator (CRC) meet, Informed Consent Form (ICF), Case Report Form (CRF)/ Status Report Form (SRF) preparation, Ethics Committee (EC) submission, etc. have been highlighted. The risk based mitigation strategy (to develop an effective risk monitoring plan before staring a clinical trial) has also been suggested by authors. A well-tailored and integrated plan, recognition of potential risks and their mitigation strategy can result in the pre exclusion or end to end solution of all the risks associated with pre- phase of clinical trials. PMID:26435140

  1. Use of Auricular Acupressure to Improve the Quality of Life in Diabetic Patients with Chronic Kidney Diseases: A Prospective Randomized Controlled Trial

    OpenAIRE

    Shaoqing Wang; Zhaohui Chen; Ping Fu; Li Zang; Li Wang; Xi Zhai; Fang Gao; Aijing Huang; Yao Zhang

    2014-01-01

    Background. Diabetic patients with chronic kidney disease (CKD) suffer from low quality of life (QOL). We aim to assess the effectiveness of auricular acupressure for QOL improvement in these patients. Materials and Methods. Sixty-two participants were randomly assigned to an auricular or a control arm in a randomized controlled trial. Participants in the auricular arm were instructed to perform auricular acupressure 3–5 times per day for 3 months, when they were receiving conventional treatm...

  2. Internet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder versus waitlist control: study protocol for a randomised controlled trial

    OpenAIRE

    Allen, Adrian R.; Newby, Jill M; Smith, Jessica; Andrews, Gavin

    2015-01-01

    Background This randomised controlled trial (RCT) with two parallel arms will evaluate the efficacy of an internet-delivered six-lesson 10-week cognitive behavioural therapy (iCBT) intervention for posttraumatic stress disorder (PTSD). It will also investigate the association between changes in PTSD symptoms, intolerance of uncertainty (IU) and emotion regulation. Methods/Design Patients with PTSD will be recruited via the research arm of a not-for-profit clinical and research unit in Austral...

  3. The Norma arm region Chandra survey catalog: X-ray populations in the spiral arms

    Energy Technology Data Exchange (ETDEWEB)

    Fornasini, Francesca M. [Astronomy Department, University of California, 601 Campbell Hall, Berkeley, CA 94720 (United States); Tomsick, John A.; Bodaghee, Arash; Krivonos, Roman A. [Space Sciences Laboratory, 7 Gauss Way, University of California, Berkeley, CA 94720 (United States); An, Hongjun [Department of Physics, McGill University, Rutherford Physics Building, 3600 University Street, Montreal, QC H3A 2T8 (Canada); Rahoui, Farid [European Southern Observatory, Karl Schwarzschild-Strasse 2, D-85748 Garching bei München (Germany); Gotthelf, Eric V. [Columbia Astrophysics Laboratory, Columbia University, 550 West 120th Street, New York, NY 10027 (United States); Bauer, Franz E. [Instituto de Astrofísica, Facultad de Física, Pontificia Universidad Católica de Chile, 306, Santiago 22 (Chile); Stern, Daniel, E-mail: f.fornasini@berkeley.edu [Jet Propulsion Laboratory, California Institute of Technology, 4800 Oak Grove Drive, MS 169-506, Pasadena, CA 91109 (United States)

    2014-12-01

    We present a catalog of 1415 X-ray sources identified in the Norma Arm Region Chandra Survey (NARCS), which covers a 2° × 0.°8 region in the direction of the Norma spiral arm to a depth of ≈20 ks. Of these sources, 1130 are point-like sources detected with ≥3σ confidence in at least one of three energy bands (0.5-10, 0.5-2, and 2-10 keV), five have extended emission, and the remainder are detected at low significance. Since most sources have too few counts to permit individual classification, they are divided into five spectral groups defined by their quantile properties. We analyze stacked spectra of X-ray sources within each group, in conjunction with their fluxes, variability, and infrared counterparts, to identify the dominant populations in our survey. We find that ∼50% of our sources are foreground sources located within 1-2 kpc, which is consistent with expectations from previous surveys. Approximately 20% of sources are likely located in the proximity of the Scutum-Crux and near Norma arm, while 30% are more distant, in the proximity of the far Norma arm or beyond. We argue that a mixture of magnetic and nonmagnetic cataclysmic variables dominates the Scutum-Crux and near Norma arms, while intermediate polars and high-mass stars (isolated or in binaries) dominate the far Norma arm. We also present the cumulative number count distribution for sources in our survey that are detected in the hard energy band. A population of very hard sources in the vicinity of the far Norma arm and active galactic nuclei dominate the hard X-ray emission down to f{sub X} ≈ 10{sup –14} erg cm{sup –2} s{sup –1}, but the distribution curve flattens at fainter fluxes. We find good agreement between the observed distribution and predictions based on other surveys.

  4. The Norma arm region Chandra survey catalog: X-ray populations in the spiral arms

    International Nuclear Information System (INIS)

    We present a catalog of 1415 X-ray sources identified in the Norma Arm Region Chandra Survey (NARCS), which covers a 2° × 0.°8 region in the direction of the Norma spiral arm to a depth of ≈20 ks. Of these sources, 1130 are point-like sources detected with ≥3σ confidence in at least one of three energy bands (0.5-10, 0.5-2, and 2-10 keV), five have extended emission, and the remainder are detected at low significance. Since most sources have too few counts to permit individual classification, they are divided into five spectral groups defined by their quantile properties. We analyze stacked spectra of X-ray sources within each group, in conjunction with their fluxes, variability, and infrared counterparts, to identify the dominant populations in our survey. We find that ∼50% of our sources are foreground sources located within 1-2 kpc, which is consistent with expectations from previous surveys. Approximately 20% of sources are likely located in the proximity of the Scutum-Crux and near Norma arm, while 30% are more distant, in the proximity of the far Norma arm or beyond. We argue that a mixture of magnetic and nonmagnetic cataclysmic variables dominates the Scutum-Crux and near Norma arms, while intermediate polars and high-mass stars (isolated or in binaries) dominate the far Norma arm. We also present the cumulative number count distribution for sources in our survey that are detected in the hard energy band. A population of very hard sources in the vicinity of the far Norma arm and active galactic nuclei dominate the hard X-ray emission down to fX ≈ 10–14 erg cm–2 s–1, but the distribution curve flattens at fainter fluxes. We find good agreement between the observed distribution and predictions based on other surveys.

  5. A protocol for a trial of homeopathic treatment for irritable bowel syndrome

    Directory of Open Access Journals (Sweden)

    Peckham Emily J

    2012-11-01

    Full Text Available Abstract Background Irritable bowel syndrome is a chronic condition with no known cure. Many sufferers seek complementary and alternative medicine including homeopathic treatment. However there is much controversy as to the effectiveness of homeopathic treatment. This three-armed study seeks to explore the effectiveness of individualised homeopathic treatment plus usual care compared to both an attention control plus usual care and usual care alone, for patients with irritable bowel syndrome. Methods/design This is a three-armed pragmatic randomised controlled trial using the cohort multiple randomised trial methodology. Patients are recruited to an irritable bowel syndrome cohort from primary and secondary care using GP databases and consultants lists respectively. From this cohort patients are randomly selected to be offered, 5 sessions of homeopathic treatment plus usual care, 5 sessions of supportive listening plus usual care or usual care alone. The primary clinical outcome is the Irritable Bowel Syndrome Symptom Severity at 26 weeks. From a power calculation, it is estimated that 33 people will be needed for the homeopathic treatment arm and 132 for the usual care arm, to detect a minimal clinical difference at 80 percent power and 5 percent significance allowing for loss to follow up. An unequal group size has been used for reasons of cost. Analysis will be by intention to treat and will compare homeopathic treatment with usual care at 26 weeks as the primary analysis, and homeopathic treatment with supportive listening as an additional analysis. Discussion This trial has received NHS approval and results are expected in 2013. Trial registration Current Controlled Trials ISRCTN90651143

  6. Design of a novel 3-DOF hybrid mechanical arm

    Institute of Scientific and Technical Information of China (English)

    LI YanBiao; JIN ZhenLin; JI ShiMing

    2009-01-01

    Parameter optimization for a novel 3-DOF hybrid mechanical arm was presented by using a statistics method called the statistics parameters optimization method based on index atlases.Several kinematics and mechanics performance evaluation indices were proposed and discussed,according to the kinematics and mechanics analyses of the mechanical arm.Considering the assembly technique,a prototype of the 3-DOF hybrid mechanical arm was developed,which provided a basis for applications of the 3-DOF hybrid mechanical arm.The novel 3-DOF hybrid mechanical arm can be applied to the modern industrial fields requiring high stiffness,lower inertia and good technological efficiency.A novel 6-DOF hybrid humanoid mechanical arm was built,in which the present mechanical arm was connected with a spherical 3-DOF parallel manipulator.

  7. Repurposing historical control clinical trial data to provide safety context.

    Science.gov (United States)

    Bhuyan, Prakash; Desai, Jigar; Louis, Matthew St; Carlsson, Martin; Bowen, Edward; Danielson, Mark; Cantor, Michael N

    2016-02-01

    Billions of dollars spent, millions of subject-hours of clinical trial experience and an abundance of archived study-level data, yet why are historical data underutilized? We propose that historical data can be aggregated to provide safety, background incidence rate and context to improve the evaluation of new medicinal products. Here, we describe the development and application of the eControls database, which is derived from the control arms of studies of licensed products, and discuss the challenges and potential solutions to the proper application of historical data to help interpret product safety. PMID:26523771

  8. Development of a 3D immersive videogame to improve arm-postural coordination in patients with TBI

    Directory of Open Access Journals (Sweden)

    Cassavaugh Nicholas D

    2011-10-01

    Full Text Available Abstract Background Traumatic brain injury (TBI disrupts the central and executive mechanisms of arm(s and postural (trunk and legs coordination. To address these issues, we developed a 3D immersive videogame-- Octopus. The game was developed using the basic principles of videogame design and previous experience of using videogames for rehabilitation of patients with acquired brain injuries. Unlike many other custom-designed virtual environments, Octopus included an actual gaming component with a system of multiple rewards, making the game challenging, competitive, motivating and fun. Effect of a short-term practice with the Octopus game on arm-postural coordination in patients with TBI was tested. Methods The game was developed using WorldViz Vizard software, integrated with the Qualysis system for motion analysis. Avatars of the participant's hands precisely reproducing the real-time kinematic patterns were synchronized with the simulated environment, presented in the first person 3D view on an 82-inch DLP screen. 13 individuals with mild-to-moderate manifestations of TBI participated in the study. While standing in front of the screen, the participants interacted with a computer-generated environment by popping bubbles blown by the Octopus. The bubbles followed a specific trajectory. Interception of the bubbles with the left or right hand avatar allowed flexible use of the postural segments for balance maintenance and arm transport. All participants practiced ten 90-s gaming trials during a single session, followed by a retention test. Arm-postural coordination was analysed using principal component analysis. Results As a result of the short-term practice, the participants improved in game performance, arm movement time, and precision. Improvements were achieved mostly by adapting efficient arm-postural coordination strategies. Of the 13 participants, 10 showed an immediate increase in arm forward reach and single-leg stance time. Conclusion

  9. Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERAS® programme (ORANGE II – Trial: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van Dam Ronald M

    2012-05-01

    Full Text Available Abstract Background The use of lLaparoscopic liver resection in terms of time to functional recovery, length of hospital stay (LOS, long-term abdominal wall hernias, costs and quality of life (QOL has never been studied in a randomised controlled trial. Therefore, this is the subject of the international multicentre randomised controlled ORANGE II trial. Methods Patients eligible for left lateral sectionectomy (LLS of the liver will be recruited and randomised at the outpatient clinic. All randomised patients will undergo surgery in the setting of an ERAS programme. The experimental design produces two randomised arms (open and laparoscopic LLS and a prospective registry. The prospective registry will be based on patients that cannot be randomised because of the explicit treatment preference of the patient or surgeon, or because of ineligibility (not meeting the in- and exclusion criteria for randomisation in this trial. Therefore, all non-randomised patients undergoing LLS will be approached to participate in the prospective registry, thereby allowing acquisition of an uninterrupted prospective series of patients. The primary endpoint of the ORANGE II trial is time to functional recovery. Secondary endpoints are postoperative LOS, percentage readmission, (liver-specific morbidity, QOL, body image and cosmetic result, hospital and societal costs over 1 year, and long-term incidence of incisional hernias. It will be assumed that in patients undergoing laparoscopic LLS, length of hospital stay can be reduced by two days. A sample size of 55 patients in each randomisation arm has been calculated to detect a 2-day reduction in LOS (90% power and α = 0.05 (two-tailed. The ORANGE II trial is a multicenter randomised controlled trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing LLS within an enhanced recovery ERAS programme. Trial registration ClinicalTrials.gov NCT00874224.

  10. Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility: pragmatic randomised controlled trial

    OpenAIRE

    Bhattacharya, S; Harrild, K; Mollison, J; Wordsworth, S; Tay, C; Harrold, A; McQueen, D; Lyall, H; L. Johnston; Burrage, J; Grossett, S; Walton, H; Lynch, J; Johnstone, A.; Kini, S

    2008-01-01

    Objective To compare the effectiveness of clomifene citrate and unstimulated intrauterine insemination with expectant management for the treatment of unexplained infertility. Design Three arm parallel group, pragmatic randomised controlled trial. Setting Four teaching hospitals and a district general hospital in Scotland. Participants Couples with infertility for over two years, confirmed ovulation, patent fallopian tubes, and motile sperm. Intervention Expectant management, oral clomifene ci...

  11. A randomized phase II trial of tacrolimus, mycophenolate mofetil and sirolimus after non-myeloablative unrelated donor transplantation

    DEFF Research Database (Denmark)

    Kornblit, Brian; Maloney, David G; Storer, Barry E;

    2014-01-01

    The study is a randomized phase II trial investigating graft-versus-host disease prophylaxis after non-myeloablative (90 mg/m(2) fludarabine and 2 Gy total body irradiation) human leukocyte antigen matched unrelated donor transplantation. Patients were randomized as follows: arm 1 - tacrolimus 18...

  12. Complementary and Alternative Medicine Cancer Clinical Trials

    Science.gov (United States)

    ... Introduction Cancer CAM Clinical Trials Introduction What are clinical trials? A clinical trial is one of the final ... and effective. What are the different types of clinical trials? Treatment trials test new treatments (like a new ...

  13. Comparison communities in a cluster randomised trial innovate in response to 'being controlled'.

    Science.gov (United States)

    Hawe, Penelope; Riley, Therese; Gartrell, Alexandra; Turner, Karen; Canales, Claudia; Omstead, Darlene

    2015-05-01

    We conducted qualitative interviews among primary health care teams and community agencies in eight communities in Victoria, Australia which had (1) agreed to be part of a universal primary care and community development intervention to reduce post natal depression and promote maternal health; and (2) were randomised to the comparison arm. The purpose was to document their experience with and interpretation of the trial. Although 'control' in a controlled trial refers to the control of confounding of the trial result by factors other than allocation to the intervention, participants interpreted 'control' to mean restrictions on what they were allowed to do during the trial period. They had agreed not to use the Edinburgh Post Natal Depression Scale or the SF 36 in clinical practice and not to implement any of the elements of the intervention. We found that no elements of the intervention were implemented. However, the extension of the trial from three to five years made the trial agreement a strain. The imposition of trial conditions also encouraged a degree of lateral thinking and innovation in service delivery (quality improvement). This may have potentially contributed to the null trial results. The observations invite interrogation of intervention theory and consequent rethinking of the way contamination in a cluster trial is defined. PMID:25863725

  14. Dual arm robotic system with sensory input

    Science.gov (United States)

    Ozguner, U.

    1987-01-01

    The need for dual arm robots in space station assembly and satellite maintainance is of increasing significance. Such robots will be in greater demand in the future when numerous tasks will be assigned to them to relieve the direct intervention of humans in space. Technological demands from these robots will be high. They will be expected to perform high speed tasks with a certain degree of autonomy. Various levels of sensing will have to be used in a sophisticated control scheme. Ongoing research in control, sensing and real-time software to produce a two-arm robotic system than can accomplish generic assembly tasks is discussed. The control hierarchy and the specific control approach are discussed. A decentralized implementation of model-reference adaptive control using Variable Structure controllers and the incorporation of tactile feedback is considered.

  15. Parametric instabilities in the LCGT arm cavity

    Science.gov (United States)

    Yamamoto, K.; Uchiyama, T.; Miyoki, S.; Ohashi, M.; Kuroda, K.; Numata, K.

    2008-07-01

    We evaluated the parametric instabilities of LCGT (Japanese interferometric gravitational wave detector project) arm cavity. The number of unstable modes of LCGT is 10-times smaller than that of Advanced LIGO (USA). Since the strength of the instabilities of LCGT depends on the mirror curvature more weakly than that of Advanced LIGO, the requirement of the mirror curvature accuracy is easier to be achieved. The difference in the parametric instabilities between LCGT and Advanced LIGO is because of the thermal noise reduction methods (LCGT, cooling sapphire mirrors; Advanced LIGO, fused silica mirrors with larger laser beams), which are the main strategies of the projects. Elastic Q reduction by the barrel surface (0.2 mm thickness Ta2O5) coating is effective to suppress instabilities in the LCGT arm cavity. Therefore, the cryogenic interferometer is a smart solution for the parametric instabilities in addition to thermal noise and thermal lensing.

  16. Parametric instabilities in the LCGT arm cavity

    CERN Document Server

    Yamamoto, K; Miyoki, S; Ohashi, M; Kuroda, K; Numata, K

    2008-01-01

    We evaluated the parametric instabilities of LCGT (Japanese interferometric gravitational wave detector project) arm cavity. The number of unstable modes of LCGT is 10-times smaller than that of Advanced LIGO (U.S.A.). Since the strength of the instabilities of LCGT depends on the mirror curvature more weakly than that of Advanced LIGO, the requirement of the mirror curvature accuracy is easier to be achieved. The difference in the parametric instabilities between LCGT and Advanced LIGO is because of the thermal noise reduction methods (LCGT, cooling sapphire mirrors; Advanced LIGO, fused silica mirrors with larger laser beams), which are the main strategies of the projects. Elastic Q reduction by the barrel surface (0.2 mm thickness Ta$_2$O$_5$) coating is effective to suppress instabilities in the LCGT arm cavity. Therefore, the cryogenic interferometer is a smart solution for the parametric instabilities in addition to thermal noise and thermal lensing.

  17. MAGIC: Marine ARM GPCI Investigation of Clouds

    Energy Technology Data Exchange (ETDEWEB)

    Lewis, ER; Wiscombe, WJ; Albrecht, BA; Bland, GL; Flagg, CN; Klein, SA; Kollias, P; Mace, G; Reynolds, RM; Schwartz, SE; Siebesma, AP; Teixeira, J; Wood, R; Zhang, M

    2012-10-03

    The second Atmospheric Radiation Measurement (ARM) Mobile Facility (AMF2) will be deployed aboard the Horizon Lines cargo container ship merchant vessel (M/V) Spirit for MAGIC, the Marine ARM GPCI1 Investigation of Clouds. The Spirit will traverse the route between Los Angeles, California, and Honolulu, Hawaii, from October 2012 through September 2013 (except for a few months in the middle of this time period when the ship will be in dry dock). During this field campaign, AMF2 will observe and characterize the properties of clouds and precipitation, aerosols, and atmospheric radiation; standard meteorological and oceanographic variables; and atmospheric structure. There will also be two intensive observational periods (IOPs), one in January 2013 and one in July 2013, during which more detailed measurements of the atmospheric structure will be made.

  18. Special Gripper for a Robotic Arm

    Directory of Open Access Journals (Sweden)

    Miguel Angel SELLES

    2012-12-01

    Full Text Available New structures for gripping objects in robotic manipulation processes are oriented to the new arrangement of mechanical structures using new materials and processing technologies and innovative procedures for the implementation of contact gripping element links to an object with a high degree of adaptively of applications together with the ability to alter the structure of grip and limiting the intensity of the contact stiffness variation of snap elements custody and pliability. The application of elastomeric materials and surface finishes is important. This paper presents both a new gripper design for robot arms but also the search of the selected materials to make an experimental evaluation of technical parameters that are used to assess their application potential and suitability for the targeted applications. Also the results and conclusions for gripper testing in manipulation operations with two different robot arms are presented.

  19. A Phase 2 Randomized Trial of a Rifapentine plus Moxifloxacin-Based Regimen for Treatment of Pulmonary Tuberculosis.

    Directory of Open Access Journals (Sweden)

    Marcus B Conde

    Full Text Available The combination of rifapentine and moxifloxacin administered daily with other anti-tuberculosis drugs is highly active in mouse models of tuberculosis chemotherapy. The objective of this phase 2 clinical trial was to determine the bactericidal activity, safety, and tolerability of a regimen comprised of rifapentine, moxifloxacin, isoniazid, and pyrazinamide administered daily during the first 8 weeks of pulmonary tuberculosis treatment.Adults with sputum smear-positive pulmonary tuberculosis were randomized to receive either rifapentine (approximately 7.5 mg/kg plus moxifloxacin (investigational arm, or rifampin (approximately 10 mg/kg plus ethambutol (control daily for 8 weeks, along with isoniazid and pyrazinamide. The primary endpoint was sputum culture status at completion of 8 weeks of treatment.121 participants (56% of accrual target were enrolled. At completion of 8 weeks of treatment, negative cultures using Löwenstein-Jensen (LJ medium occurred in 47/60 (78% participants in the investigational arm vs. 43/51 (84%, p = 0.47 in the control arm; negative cultures using liquid medium occurred in 37/47 (79% in the investigational arm vs. 27/41 (66%, p = 0.23 in the control arm. Time to stable culture conversion was shorter for the investigational arm vs. the control arm using liquid culture medium (p = 0.03, but there was no difference using LJ medium. Median rifapentine area under the concentration-time curve (AUC0-24 was 313 mcg*h/mL, similar to recent studies of rifapentine dosed at 450-600 mg daily. Median moxifloxacin AUC0-24 was 28.0 mcg*h/mL, much lower than in trials where rifapentine was given only intermittently with moxifloxacin. The proportion of participants discontinuing assigned treatment for reasons other than microbiological ineligibility was higher in the investigational arm vs. the control arm (11/62 [18%] vs. 3/59 [5%], p = 0.04 although the proportions of grade 3 or higher adverse events were similar (5/62 [8%] in the

  20. Memories of the armed struggle in Argentina

    OpenAIRE

    Laura Margarita Pasquali

    2013-01-01

    This article presents and develops some of the edges on working of the guerrilla that emerge in the memories of the former militants of the armed organizations in Argentina. Beginig from this journey we will have access to the registration that one has presently on it, which will allows us to establish part of the subjective environment of the moment, the main characters consideration of the activism and their significance in the general context of the militancy.

  1. Financial Ratio Analysis using ARMS Data

    OpenAIRE

    2012-01-01

    The purpose of this research is to evaluate the financial performance measures calculated and reported by Economic Resource Service (ERS) from ARMS data. The evaluation includes the calculation method and the underlying assumptions used in obtaining the reported values. The financial measures calculated and reported are compared with those recommended by the Farm Financial Standards Council (FFSC). The underlying assumptions are identified by analyzing the software code used in calculating th...

  2. Planar Robot Arm Modelling and Control

    OpenAIRE

    Hernández González, Francisco

    2012-01-01

    The thesis objective is to model a one link robotic arm mounted on a sliding mobile platform and to investigate different control strategies under the effect of gravity and external force disturbance. For simplicity the robotic set up can be modelled and controlled as an inverted pendulum moving on a non constant sloping surface. Firstly the control is done on level ground. This lower mathematical complexity will be taken as an advantage to approach the analysis on aspects more related with c...

  3. Arms-control treaties: Review and revision

    International Nuclear Information System (INIS)

    The Non-Proliferation Treaty, which currently has 121 States as parties and comes up for review in 1985, stands among modern arms-control agreements that increasingly incorporate special legal clauses to facilitate their future adaptation to changing circumstances, conditions, and developments. This article examines, from legal and historical perspectives, what the concept of ''review'' entails and how it differs from ''revision'' as a legal instrument for peaceful change

  4. Automation Using Robotic Arm in Rotor Packaging

    OpenAIRE

    G. Gopu; ARJUN SHIBY M; NAGA ARJUN M; SHASHANK R; SINAN V

    2013-01-01

    Till date automation in small and medium scale industries has not enjoyed the same rate of growth as in other information technology sectors, lagging significantly behind automation in large batch production .The use of LabVIEW interfaced with micro-controller in controlling a robotic arm is a latest technique which is being implemented in this project. In medium scale industries packaging of rotors is done manually. This Process is time consuming and also requires manpower. Through this proj...

  5. The Temporal Structure of Vertical Arm Movements

    Science.gov (United States)

    Gaveau, Jérémie; Papaxanthis, Charalambos

    2011-01-01

    The present study investigates how the CNS deals with the omnipresent force of gravity during arm motor planning. Previous studies have reported direction-dependent kinematic differences in the vertical plane; notably, acceleration duration was greater during a downward than an upward arm movement. Although the analysis of acceleration and deceleration phases has permitted to explore the integration of gravity force, further investigation is necessary to conclude whether feedforward or feedback control processes are at the origin of this incorporation. We considered that a more detailed analysis of the temporal features of vertical arm movements could provide additional information about gravity force integration into the motor planning. Eight subjects performed single joint vertical arm movements (45° rotation around the shoulder joint) in two opposite directions (upwards and downwards) and at three different speeds (slow, natural and fast). We calculated different parameters of hand acceleration profiles: movement duration (MD), duration to peak acceleration (D PA), duration from peak acceleration to peak velocity (D PA-PV), duration from peak velocity to peak deceleration (D PV-PD), duration from peak deceleration to the movement end (D PD-End), acceleration duration (AD), deceleration duration (DD), peak acceleration (PA), peak velocity (PV), and peak deceleration (PD). While movement durations and amplitudes were similar for upward and downward movements, the temporal structure of acceleration profiles differed between the two directions. More specifically, subjects performed upward movements faster than downward movements; these direction-dependent asymmetries appeared early in the movement (i.e., before PA) and lasted until the moment of PD. Additionally, PA and PV were greater for upward than downward movements. Movement speed also changed the temporal structure of acceleration profiles. The effect of speed and direction on the form of acceleration

  6. About the principles of armed conflicts rights

    International Nuclear Information System (INIS)

    The international instruments approved in relation to restriction of war right are studied and their relevant clauses are interpreted in the article. The author lists the principles of choosing the ways and methods of conducting the war, and states that at present one of the aspects for regulation of the armed conflicts from the international and legal standpoint is to implement the operations for protection of peace or good will operations as well

  7. The Indo-Pakistani Arms Competition

    OpenAIRE

    Ido Oren

    1994-01-01

    The author applies to South Asia a theory of armament that he developed in the context of the superpowers' arms rivalry. The empirical findings are consistent with the results for the superpowers' case: India and Pakistan are found to have matched high levels of armaments with low levels and vice versa. Such results are analytically similar to empirical evidence on alliances showing that states, including India and Pakistan, often ally with the stronger against the weaker side. In both cases ...

  8. Tags and seals for arms control verification

    Energy Technology Data Exchange (ETDEWEB)

    DeVolpi, A.

    1990-09-18

    Tags and seals have long been recognized as important tools in arms control. The trend in control of armaments is to limit militarily significant equipment that is capable of being verified through direct and cooperative means, chiefly on-site inspection or monitoring. Although this paper will focus on the CFE treaty, the role of tags and seals for other treaties will also be addressed. Published technology and concepts will be reviewed, based on open sources. Arms control verification tags are defined as unique identifiers designed to be tamper-revealing; in that respect, seals are similar, being used as indicators of unauthorized access. Tamper-revealing tags might be considered as single-point markers, seals as two-point couplings, and nets as volume containment. The functions of an arms control tag can be considered to be two-fold: to provide field verification of the identity of a treaty-limited item (TLI), and to have a means of authentication of the tag and its tamper-revealing features. Authentication could take place in the field or be completed elsewhere. For CFE, the goal of tags and seals can be to reduce the overall cost of the entire verification system.

  9. Arms control agency faces uncertain future

    International Nuclear Information System (INIS)

    National security cognoscenti are busy sifting tea leaves trying to puzzle out the fate of arms control and nonproliferation policy in the new Administration. Of special concern to these policy gurus is the future of the semiautonomous Arms Control and Disarmament Agency (ACDA). ACDA's existence as a separate entity on the executive branch's organization chart is precarious. The agency has never functioned as intended since Congress created it in 1961. Its stock over the decades has ebbed and flowed, paralleling the prominence and clout of its director. And except for a few notable successes--the conclusion of the chemical weapons treaty being one--the agency's authority has plummeted in the past 14 years. Today, almost every interested party agrees that something has to be done, that the agency cannot continue as it now functions. Several recent studies have called for its rejuvenation. Still other studies have suggested that ACDA be dismantled, and those activities relevant to national security in a post-Cold War environment be shifted to and integrated into the State Department. Observers expect ACDA to evolve into an agency whose primary focus is on problems of proliferation. In a world in which tighter export controls on dual-use technologies, restraint on arms transfers, and economic assistance conditional on a recipients's security behavior will be the norm for security and stability, a role for ACDA as the U.S.'s nonproliferation nanny is not a bad one

  10. Humanoid Robot Arm Adaptive Control: Experimental Implementation

    Directory of Open Access Journals (Sweden)

    Said G. Khan

    2014-01-01

    Full Text Available In this study, a partially model based adaptive control of humanoid robot arm is presented. The aim of the adaptive control scheme is to deal with the uncertain parameters in its own dynamic model such as link masses or actuators inertias as well as to cope with changing dynamics in the tasks like passing objects between a human and a robot. The main idea here is to derive a dynamic model of the robot’s arm via a software package and parameterized it. Then, employ the adaptive control scheme to identify uncertain parameters such as link masses and actuator inertias online. This scheme will also be suitable for the tasks where robot is lifting weight and or passing an object to a human or vice versa (which is the ultimate goal of this work. The adaptive scheme is simulated and experimentally tested on the Bristol Robotics Laboratory humanoid Bristol- Elumotion-Robot-Torso (BERT Arm. Humanoid BERT robot is developed as a collaboration between Bristol Robotics Laboratory and Elumotion (a Bristol based robotic company.

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

    International Nuclear Information System (INIS)

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

  12. Health coaching by telephony to support self-care in chronic diseases: clinical outcomes from The TERVA randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Patja Kristiina

    2012-06-01

    Full Text Available Abstract Background The aim was to evaluate the effect of a 12-month individualized health coaching intervention by telephony on clinical outcomes. Methods An open-label cluster-randomized parallel groups trial. Pre- and post-intervention anthropometric and blood pressure measurements by trained nurses, laboratory measures from electronic medical records (EMR. A total of 2594 patients filling inclusion criteria (age 45 years or older, with type 2 diabetes, coronary artery disease or congestive heart failure, and unmet treatment goals were identified from EMRs, and 1535 patients (59% gave consent and were randomized into intervention or control arm. Final analysis included 1221 (80% participants with data on primary end-points both at entry and at end. Primary outcomes were systolic and diastolic blood pressure, serum total and LDL cholesterol concentration, waist circumference for all patients, glycated hemoglobin (HbA1c for diabetics and NYHA class in patients with congestive heart failure. The target effect was defined as a 10-percentage point increase in the proportion of patients reaching the treatment goal in the intervention arm. Results The proportion of patients with diastolic blood pressure initially above the target level decreasing to 85 mmHg or lower was 48% in the intervention arm and 37% in the control arm (difference 10.8%, 95% confidence interval 1.5–19.7%. No significant differences emerged between the arms in the other primary end-points. However, the target levels of systolic blood pressure and waist circumference were reached non-significantly more frequently in the intervention arm. Conclusions Individualized health coaching by telephony, as implemented in the trial was unable to achieve majority of the disease management clinical measures. To provide substantial benefits, interventions may need to be more intensive, target specific sub-groups, and/or to be fully integrated into local health care. Trial registration

  13. Complementary feeding: a Global Network cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Pasha Omrana

    2011-01-01

    Full Text Available Abstract Background Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. Methods/Design A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months; neurocognitive development (12 and 18 months; and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Discussion Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will

  14. Synergic Effect of Compression Therapy and Controlled Active Exercises Using a Facilitating Device in the Treatment of Arm Lymphedema

    Directory of Open Access Journals (Sweden)

    Maria de Fátima Guerreiro Godoy, Maria Regina Pereira, Antonio Helio Oliani, Jose Maria Pereira de Godoy

    2012-01-01

    Full Text Available Trial design: A randomized controlled trial was performed to evaluate the effect of the combination of compression therapy with active exercising using a facilitating apparatus on arm lymphedema. Method: Twenty women with a mean age of 63.3 years were evaluated; all had lymphedema resulting from breast cancer treatment. The inclusion criterion was a difference of 200 mL in size between arms. The apparatus used, called 'pulley system', is a vertical iron wheel fixed on a support at a distance of 10 cm from the patient's body. Participants were submitted to two series of active exercises using this facilitating device, one series using a compression sleeve and the other without. Each series consisted of four 12-minute sessions of exercises separated by 3-minute rest intervals. Volumetry was performed before and after each series of exercises. The paired t-test was utilized for statistical analysis (p-value < 0.05. Results: A significant mean reduction (p-value < 0.007 and non-significant mean increase (p-value < 0.2 in volumes were observed during exercising with and without compression, respectively. Conclusion: Controlled active exercising utilizing a facilitating apparatus while wearing a compression sleeve reduces the size of lymphedematous arms.

  15. Two-arm master/slave manipulator for nuclear facilities

    International Nuclear Information System (INIS)

    Several kinds of one-arm manipulators have been developed for remote maintenance in nuclear facilities to reduce personnel radiation exposure and to keep plant availability as high as possible. In those maintenance tasks, however, there are many that need two arms, e.g., one arm holds the work object and the other arm cuts it with a plasma torch. To answer this need, a dexterous two-arm master/slave manipulator has been developed based on the technology for one-arm manipulators. A prototype two-arm/slave manipulator is shown. The specifications for master and slave manipulators are listed. The prototype two-arm manipulator is undergoing laboratory performance tests. Preliminary results showed the maximum static operating forces were 0.4 N for the all-direct drive (DD)-type arm and 1.1 N for the semi-DD type. The payload for each arm of the slave manipulator was confirmed as 10 kgf, using mock pieces. The decommissioning tasks of cutting pipes and steel plates were successfully carried out

  16. CHARACTERISTICS OF SPIRAL ARMS IN LATE-TYPE GALAXIES

    International Nuclear Information System (INIS)

    We have measured the positions of large numbers of H II regions in four nearly face-on, late-type, spiral galaxies: NGC 628 (M74), NGC 1232, NGC 3184, and NGC 5194 (M51). Fitting log-periodic spiral models to segments of each arm yields local estimates of spiral pitch angle and arm width. While pitch angles vary considerably along individual arms, among arms within a galaxy, and among galaxies, we find no systematic trend with galactocentric distance. We estimate the widths of the arm segments from the scatter in the distances of the H II regions from the spiral model. All major arms in these galaxies show spiral arm width increasing with distance from the galactic center, similar to the trend seen in the Milky Way. However, in the outermost parts of the galaxies, where massive star formation declines, some arms reverse this trend and narrow. We find that spiral arms often appear to be composed of segments of ∼5 kpc length, which join to form kinks and abrupt changes in pitch angle and arm width; these characteristics are consistent with properties seen in the large N-body simulations of D'Onghia et al. and others

  17. Optimizing Armed Forces Capabilities for Hybrid Warfare – New Challenge for Slovak Armed Forces

    Directory of Open Access Journals (Sweden)

    Peter PINDJÁK

    2015-09-01

    Full Text Available The paper deals with the optimization of military capabilities of the Slovak Armed Forces for conducting operations in a hybrid conflict, which represents one of the possible scenarios of irregular warfare. Whereas in the regular warfare adversaries intend to eliminate the centers of gravity of each other, most often command and control structures, in irregular conflicts, the center of gravity shifts towards the will and cognitive perception of the target population. Hybrid warfare comprises a thoroughly planned combination of conventional military approaches and kinetic operations with subversive, irregular activities, including information and cyber operations. These efforts are often accompanied by intensified activities of intelligence services, special operation forces, and even mercenary and other paramilitary groups. The development of irregular warfare capabilities within the Slovak Armed Forces will require a progressive transformation process that may turn the armed forces into a modern and adaptable element of power, capable of deployment in national and international crisis management operations.

  18. Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice

    Directory of Open Access Journals (Sweden)

    Tulledge-Scheitel Sidna M

    2009-12-01

    Full Text Available Abstract Background Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1 preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE for postmenopausal women at risk for osteoporotic fractures; and (2 assess the feasibility and validity (i.e., absence of contamination of patient-level randomization (vs. cluster randomization in pilot trials of decision aid efficacy. Methods/Design This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of STEOPOROSIS CHOICE on five outcomes: (a patient knowledge regarding osteoporosis risk factors and treatment; (b quality of the decision-making process for both the patient and clinician; (c patient and clinician acceptability and satisfaction with the decision aid; (d rate of bisphosphonate use and adherence, and (e trial processes (e.g., ability to recruit participants, collect patient outcomes. To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination. Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months. Discussion This pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach -- decision aids -- to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform

  19. Adaptive trial designs.

    Science.gov (United States)

    Lai, Tze Leung; Lavori, Philip William; Shih, Mei-Chiung

    2012-01-01

    We review adaptive designs for clinical trials, giving special attention to the control of the Type I error in late-phase confirmatory trials, when the trial planner wishes to adjust the final sample size of the study in response to an unblinded analysis of interim estimates of treatment effects. We point out that there is considerable inefficiency in using the adaptive designs that employ conditional power calculations to reestimate the sample size and that maintain the Type I error by using certain weighted test statistics. Although these adaptive designs have little advantage over familiar group-sequential designs, our review also describes recent developments in adaptive designs that are both flexible and efficient. We also discuss the use of Bayesian designs, when the context of use demands control over operating characteristics (Type I and II errors) and correction of the bias of estimated treatment effects. PMID:21838549

  20. The B-VITAGE trial: A randomized trial of homocysteine lowering treatment of depression in later life

    Directory of Open Access Journals (Sweden)

    van Bockxmeer Frank

    2010-01-01

    Full Text Available Abstract Background Depression is a leading cause of disability worldwide and depressive symptoms are common in later life. Observational evidence suggests that depression is more prevalent among people with high plasma homocysteine (tHcy, but the results of randomized trials to date have been unable to show that lowering tHcy through the supplementation of vitamins B6, B12 and folate benefits depressive symptoms. We designed the B-VITAGE trial to determine whether adjunctive treatment with vitamins B6, B12 and folate increases the efficacy of standard antidepressant treatment. Methods/Design The B-VITAGE trial is a 12-month randomized, double-blind, placebo-controlled trial of daily citalopram (20 to 40 mg plus B12(0.4 mg, B6 (25 mg and folic acid (2 mg or citalopram (20 to 40 mg plus placebo for the treatment of depression in later life. The trial aims to recruit over 300 older adults with major depression (DSM-IV and has been powered to detect the impact of an intervention associated with moderate effect size. Depressive symptoms will be rated with the Montgomery-Åsberg Depression Rating Scale (MADRS. The trial has two main outcomes of interest: a reduction of 50% or more in the MADRS total score between baseline and week 12 and the remission of the depressive episode at weeks 12, 26 and 52 according to DSM-IV criteria. We hypothesize that subjects randomly allocated to the vitamin arm of the study will be more likely to show a clinically significant improvement and achieve and maintain remission of symptoms at 12, 26 and 52 weeks. Secondary outcomes of interest include compliance with treatment, reduction in the severity of depressive symptoms, switching to different antidepressants, the use of non-pharmacological antidepressant treatments, response to treatment according to MTHFRC677T genotype, and changes in cognitive function over 52 weeks. Conclusions The results of this trial will clarify whether the systematic use of B