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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. A modest proposal for dropping poor arms in clinical trials.

    Science.gov (United States)

    Proschan, Michael A; Dodd, Lori E

    2014-08-30

    This paper presents a simple procedure for clinical trials comparing several arms with control. Demand for streamlining the evaluation of new treatments has led to phase III clinical trials with more arms than would have been used in the past. In such a setting, it is reasonable that some arms may not perform as well as an active control. We introduce a simple procedure that takes advantage of negative results in some comparisons to lessen the required strength of evidence for other comparisons. We evaluate properties analytically and use them to support claims made about multi-arm multi-stage designs.

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

    Directory of Open Access Journals (Sweden)

    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.

  4. Magnitude of blood pressure reduction in the placebo arms of modern hypertension trials: implications for trials of renal denervation.

    Science.gov (United States)

    Patel, Hitesh C; Hayward, Carl; Ozdemir, Baris Ata; Rosen, Stuart D; Krum, Henry; Lyon, Alexander R; Francis, Darrel P; di Mario, Carlo

    2015-02-01

    Early phase studies of novel interventions for hypertension, such as renal sympathetic denervation, are sometimes single-armed (uncontrolled). We explored the wisdom of this by quantifying the blood pressure fall in the placebo arms of contemporary trials of hypertension. We searched Medline up to June 2014 and identified blinded, randomized trials of hypertension therapy in which the control arm received placebo medication or a sham (placebo) procedure. For nonresistant hypertension, we have identified all such trials of drugs licensed by the US Food and Drug Administration since 2000 (5 drugs). This US Food and Drug Administration-related restriction was not applied to resistant hypertension trials. This produced 7451 patients, who were allocated to a blinded control from 52 trials of nonresistant hypertension and 694 patients from 8 trials of resistant hypertension (3 drugs and 2 interventions). Systolic blood pressure fell by 5.92 mm Hg (95% confidence interval, 5.14-6.71; Pblood pressure monitoring as an inclusion criterion (z=2.84; P=0.0045), in those with higher baseline blood pressures (z=-0.3; P=0.0001), and in those where the patients were prescribed a continuous background of antihypertensives (z=-2.72; P=0.0065). The nontrivial magnitude of these apparent blood pressure reductions with perfectly ineffective intervention (placebo) illustrates that efficacy explorations of novel therapies for hypertension, once safety is established, should be performed with a randomized, appropriately controlled, and blinded design.

  5. 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

    Aims To determine the cardiovascular benefits in those originally assigned atorvastatin in the Anglo-Scandinavian Cardiac Outcomes Trial-2.2 years after closure of the lipid-lowering arm of the trial (ASCOT-LLA). Methods and results The Blood Pressure Lowering Arm of the ASCOT trial (ASCOT...... mortality, all cause mortality, development of chronic stable angina, heart failure, and peripheral arterial disease. By the end of ASCOT-LLA, there was a 36% relative risk reduction in primary events (n = 254) in favour of atorvastatin [hazard ratio (HR) 0.64, 95% CI: 0.50-0.83, P = 0.0005]. At the end...... essentially unchanged and in the case of all cause mortality, the risk reduction of 15% now achieved borderline statistical significance (P = 0.02). Conclusion Carry-over benefits from those originally assigned atorvastatin but no longer taking the drug may account for unchanged relative risk reductions...

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

    Science.gov (United States)

    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

  7. Efficacy and toxicity differences in lung cancer populations in the era of clinical trials globalization: the 'common arm' approach.

    Science.gov (United States)

    Mack, Philip C; Gandara, David R; Lara, Primo N

    2012-12-01

    Historically, notable variability has been observed in clinical trial outcomes between different regions and populations worldwide, even when employing the same cytotoxic regimen in lung cancer. These divergent results underscore the inherent challenges in interpreting trials conducted abroad and raise questions regarding the general applicability of transnational clinical trials. Various reasons have been postulated to account for these differences in efficacy and toxicity, including trial design, eligibility criteria, patient demographics and, perhaps most intriguingly, population-related pharmacogenomics. However, without methodology to control for such variables, these hypotheses remain largely untested. The authors previously developed the 'common arm' approach in order to directly compare efficacy and toxicity results of trials simultaneously performed in different countries. By standardizing clinical trial-associated variables such as treatment regimens (dose, schedule, and so on), eligibility, staging, response and toxicity criteria, this approach has the potential to determine the underlying reasons for divergences in trial outcomes across countries, and whether population-associated polymorphisms contribute to these differences. In the past decade, Japanese and US investigators have applied the common arm analytic method to trials in both extensive-stage small-cell lung cancer (SCLC) and advanced nonSCLC. In the SCLC analysis, a comparison of the cisplatin/irinotecan arms from both trials revealed significant differences in response rates and overall survival. Significant differences were also observed in the distribution of gender and performance status. The common arm analysis in nonSCLC included two trials from Japan and one from the USA, each containing a 'common' carboplatin/paclitaxel arm. Clinical results were similar in the two Japanese trials, but were significantly different from the US trial with regard to survival, neutropenia, febrile

  8. 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...

  9. A randomized cross-over trial to detect differences in arm volume after low- and heavy-load resistance exercise among patients receiving adjuvant chemotherapy for breast cancer at risk for arm lymphedema

    DEFF Research Database (Denmark)

    Bloomquist, Kira; Hayes, Sandi; Adamsen, Lis;

    2016-01-01

    BACKGROUND: In an effort to reduce the risk of breast cancer-related arm lymphedema, patients are commonly advised to avoid heavy lifting, impacting activities of daily living and resistance exercise prescription. This advice lacks evidence, with no prospective studies investigating arm volume...... changes after resistance exercise with heavy loads in this population. The purpose of this study is to determine acute changes in arm volume after a session of low- and heavy-load resistance exercise among women undergoing adjuvant chemotherapy for breast cancer at risk for arm lymphedema. METHODS...... cancer and who may be at risk of developing arm lymphedema. TRIAL REGISTRATION: Current Controlled Trials ISRCTN97332727 . Registered 12 February 2015....

  10. Treating fibromyalgia with mindfulness-based stress reduction: results from a 3-armed randomized controlled trial.

    Science.gov (United States)

    Schmidt, Stefan; Grossman, Paul; Schwarzer, Barbara; Jena, Susanne; Naumann, Johannes; Walach, Harald

    2011-02-01

    Mindfulness-based stress reduction (MBSR) is a structured 8-week group program teaching mindfulness meditation and mindful yoga exercises. MBSR aims to help participants develop nonjudgmental awareness of moment-to-moment experience. Fibromyalgia is a clinical syndrome with chronic pain, fatigue, and insomnia as major symptoms. Efficacy of MBSR for enhanced well-being of fibromyalgia patients was investigated in a 3-armed trial, which was a follow-up to an earlier quasi-randomized investigation. A total of 177 female patients were randomized to one of the following: (1) MBSR, (2) an active control procedure controlling for nonspecific effects of MBSR, or (3) a wait list. The major outcome was health-related quality of life (HRQoL) 2 months post-treatment. Secondary outcomes were disorder-specific quality of life, depression, pain, anxiety, somatic complaints, and a proposed index of mindfulness. Of the patients, 82% completed the study. There were no significant differences between groups on primary outcome, but patients overall improved in HRQoL at short-term follow-up (P=0.004). Post hoc analyses showed that only MBSR manifested a significant pre-to-post-intervention improvement in HRQoL (P=0.02). Furthermore, multivariate analysis of secondary measures indicated modest benefits for MBSR patients. MBSR yielded significant pre-to-post-intervention improvements in 6 of 8 secondary outcome variables, the active control in 3, and the wait list in 2. In conclusion, primary outcome analyses did not support the efficacy of MBSR in fibromyalgia, although patients in the MBSR arm appeared to benefit most. Effect sizes were small compared to the earlier, quasi-randomized investigation. Several methodological aspects are discussed, e.g., patient burden, treatment preference and motivation, that may provide explanations for differences. In a 3-armed randomized controlled trial in female patients suffering from fibromyalgia, patients benefited modestly from a mindfulness

  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. Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE: a randomized controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Winstein Carolee J

    2013-01-01

    Full Text Available Abstract Background Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting. The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP, compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC. Two secondary objectives are to compare ASAP to a true (active monitoring only usual and customary (UCC therapy group and to compare DEUCC and UCC. Methods/design Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS hand domain is a secondary outcome measure. The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary

  13. A randomized clinical trial comparing advanced pneumatic truncal, chest, and arm treatment to arm treatment only in self-care of arm lymphedema.

    Science.gov (United States)

    Ridner, Sheila H; Murphy, Barbara; Deng, Jie; Kidd, Nancy; Galford, Emily; Bonner, Candace; Bond, Stewart M; Dietrich, Mary S

    2012-01-01

    Treatment of the truncal lymphatics prior to treatment of the lymphedematous arm is an accepted, although not empirically tested, therapeutic intervention delivered during decongestive lymphatic therapy (DLT). Breast cancer survivors with arm lymphedema are encouraged to use these techniques when performing simple lymphatic drainage as part of their life-long lymphedema self-care. Self-massage is at times difficult and pneumatic compression devices are used by many patients to assist with self-care. One such device, the Flexitouch(®) System, replicates the techniques used during DLT; however, the need for application of pneumatic compression in unaffected truncal areas to improve self-care outcomes in arm only lymphedema is not established. The objective of this study was to compare the therapeutic benefit of truncal/chest/arm advanced pneumatic compression therapy (experimental group) verses arm only pneumatic compression (control group) in self-care for arm lymphedema without truncal involvement using the Flexitouch(®) System. Outcomes of interest were self-reported symptoms, function, arm impedance ratios, circumference, volume, and trunk circumference. Forty-two breast cancer survivors, (21 per group), with Stage II lymphedema completed 30 days of home self-care using the Flexitouch(®) System. Findings revealed a statistically significant reduction in both the number of symptoms and overall symptom burden within each group; however, there were no statistically significant differences in these outcomes between the groups. There was no statistically significant overall change or differential pattern of change between the groups in function. A statistically significant reduction in bioelectrical impedance and arm circumference within both of the groups was achieved; however, there was no statistically significant difference in reduction between groups. These findings indicate that both configurations are effective, but that there may be no added benefit to

  14. Use of accelerometers as an ergonomic assessment method for arm acceleration-a large-scale field trial.

    Science.gov (United States)

    Estill, C F; MacDonald, L A; Wenzl, T B; Petersen, M R

    2000-09-01

    Ergonomists need easy-to-use, quantitative job evaluation methods to assess risk factors for upper extremity work-related musculoskeletal disorders in field-based epidemiology studies. One device that may provide an objective measure of exposure to arm acceleration is a wrist-worn accelerometer or activity monitor. A field trial was conducted to evaluate the performance of a single-axis accelerometer using an industrial population (n=158) known to have diverse upper limb motion characteristics. The second phase of the field trial involved an examination of the relationship between more traditional observation-based ergonomic exposure measures and the monitor output among a group of assembly-line production employees (n=48) performing work tasks with highly stereotypic upper limb motion patterns. As expected, the linear acceleration data obtained from the activity monitor showed statistically significant differences between three occupational groups known observationally to have different upper limb motion requirements. Among the assembly-line production employees who performed different short-cycle assembly work tasks, statistically significant differences were also observed. Several observation-based ergonomic exposure measures were found to explain differences in the acceleration measure among the production employees who performed different jobs: hand and arm motion speed, use of the hand as a hammer, and, negatively, resisting forearm rotation from the torque of a power tool. The activity monitors were found to be easy to use and non-intrusive, and to be able to distinguish arm acceleration among groups with diverse upper limb motion characteristics as well as between different assembly job tasks where arm monitors were performed repeatedly at a fixed rate.

  15. Thiol addition to protected allyl glycosides: an improved method for the preparation of spacer-arm glycosides

    NARCIS (Netherlands)

    Vliegenthart, J.F.G.; Seeventer, P.B. van; Dorst, J.A.L.M. van; Siemerink, J.F.; Kamerling, J.P.

    1997-01-01

    A useful method for the preparation of differently functionalized sulfide spacer-arm glycosides is presented. Several protected allyl glycosides were variously elongated via a radical addition reaction with pentanethiol, methyl 3-mercaptopropionate, or 2-mercaptoethanol. The hydroxyl function of pro

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

    DEFF Research Database (Denmark)

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

    2016-01-01

    BACKGROUND: TKM-130803, a small interfering RNA lipid nanoparticle product, has been developed for the treatment of Ebola virus disease (EVD), but its efficacy and safety in humans has not been evaluated. METHODS AND FINDINGS: In this single-arm phase 2 trial, adults with laboratory-confirmed EVD...... of admission. After 14 adults with EVD had received TKM-130803, the pre-specified futility boundary was reached, indicating a probability of survival to day 14 of ≤0.55, and enrolment was stopped. Pre-treatment geometric mean Ebola virus load in the 14 TKM-130803 recipients was 2.24 × 109 RNA copies/ml plasma...

  18. Application of a Dual-Arm Robot in Complex Sample Preparation and Measurement Processes.

    Science.gov (United States)

    Fleischer, Heidi; Drews, Robert Ralf; Janson, Jessica; Chinna Patlolla, Bharath Reddy; Chu, Xianghua; Klos, Michael; Thurow, Kerstin

    2016-10-01

    Automation systems with applied robotics have already been established in industrial applications for many years. In the field of life sciences, a comparable high level of automation can be found in the areas of bioscreening and high-throughput screening. Strong deficits still exist in the development of flexible and universal fully automated systems in the field of analytical measurement. Reasons are the heterogeneous processes with complex structures, which include sample preparation and transport, analytical measurements using complex sensor systems, and suitable data analysis and evaluation. Furthermore, the use of nonstandard sample vessels with various shapes and volumes results in an increased complexity. The direct use of existing automation solutions from bioscreening applications is not possible. A flexible automation system for sample preparation, analysis, and data evaluation is presented in this article. It is applied for the determination of cholesterol in biliary endoprosthesis using gas chromatography-mass spectrometry (GC-MS). A dual-arm robot performs both transport and active manipulation tasks to ensure human-like operation. This general robotic concept also enables the use of manual laboratory devices and equipment and is thus suitable in areas with a high standardization grade.

  19. School playground surfacing and arm fractures in children: a cluster randomized trial comparing sand to wood chip surfaces.

    Directory of Open Access Journals (Sweden)

    Andrew W Howard

    2009-12-01

    Full Text Available BACKGROUND: The risk of playground injuries, especially fractures, is prevalent in children, and can result in emergency room treatment and hospital admissions. Fall height and surface area are major determinants of playground fall injury risk. The primary objective was to determine if there was a difference in playground upper extremity fracture rates in school playgrounds with wood fibre surfacing versus granite sand surfacing. Secondary objectives were to determine if there were differences in overall playground injury rates or in head injury rates in school playgrounds with wood fibre surfacing compared to school playgrounds with granite sand surfacing. METHODS AND FINDINGS: The cluster randomized trial comprised 37 elementary schools in the Toronto District School Board in Toronto, Canada with a total of 15,074 students. Each school received qualified funding for installation of new playground equipment and surfacing. The risk of arm fracture from playground falls onto granitic sand versus onto engineered wood fibre surfaces was compared, with an outcome measure of estimated arm fracture rate per 100,000 student-months. Schools were randomly assigned by computer generated list to receive either a granitic sand or an engineered wood fibre playground surface (Fibar, and were not blinded. Schools were visited to ascertain details of the playground and surface actually installed and to observe the exposure to play and to periodically monitor the depth of the surfacing material. Injury data, including details of circumstance and diagnosis, were collected at each school by a prospective surveillance system with confirmation of injury details through a validated telephone interview with parents and also through collection (with consent of medical reports regarding treated injuries. All schools were recruited together at the beginning of the trial, which is now closed after 2.5 years of injury data collection. Compliant schools included 12 schools

  20. 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

  1. 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.

  2. Postdeployment Battlemind Training for the U.K. Armed Forces: A Cluster Randomized Controlled Trial

    Science.gov (United States)

    Mulligan, Kathleen; Fear, Nicola T.; Jones, Norman; Alvarez, Helen; Hull, Lisa; Naumann, Ulrike; Wessely, Simon; Greenberg, Neil

    2012-01-01

    Objective: Combat exposure can increase the risk of subsequent psychological ill-health in armed forces (AF) personnel. A U.S. postdeployment psycho-educational intervention, Battlemind, showed a beneficial effect on mental health in U.S. military personnel exposed to high combat levels. We evaluated the effectiveness of an anglicized version of…

  3. "N"-2 Repetition Costs Depend on Preparation in Trials "n"-1 and "n"-2

    Science.gov (United States)

    Scheil, Juliane; Kleinsorge, Thomas

    2014-01-01

    In task switching, a common result supporting the notion of inhibitory processes as a determinant of switch costs is the occurrence of "n"-2 repetition costs. Evidence suggests that this effect is not affected by preparation. However, the role of preparation on preceding trials has been neglected so far. In this study, evidence for an…

  4. 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

  5. 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

  6. What differences are detected by superiority trials or ruled out by noninferiority trials? A cross-sectional study on a random sample of two-hundred two-arms parallel group randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Courvoisier Delphine S

    2010-10-01

    Full Text Available Abstract Background The smallest difference to be detected in superiority trials or the largest difference to be ruled out in noninferiority trials is a key determinant of sample size, but little guidance exists to help researchers in their choice. The objectives were to examine the distribution of differences that researchers aim to detect in clinical trials and to verify that those differences are smaller in noninferiority compared to superiority trials. Methods Cross-sectional study based on a random sample of two hundred two-arm, parallel group superiority (100 and noninferiority (100 randomized clinical trials published between 2004 and 2009 in 27 leading medical journals. The main outcome measure was the smallest difference in favor of the new treatment to be detected (superiority trials or largest unfavorable difference to be ruled out (noninferiority trials used for sample size computation, expressed as standardized difference in proportions, or standardized difference in means. Student t test and analysis of variance were used. Results The differences to be detected or ruled out varied considerably from one study to the next; e.g., for superiority trials, the standardized difference in means ranged from 0.007 to 0.87, and the standardized difference in proportions from 0.04 to 1.56. On average, superiority trials were designed to detect larger differences than noninferiority trials (standardized difference in proportions: mean 0.37 versus 0.27, P = 0.001; standardized difference in means: 0.56 versus 0.40, P = 0.006. Standardized differences were lower for mortality than for other outcomes, and lower in cardiovascular trials than in other research areas. Conclusions Superiority trials are designed to detect larger differences than noninferiority trials are designed to rule out. The variability between studies is considerable and is partly explained by the type of outcome and the medical context. A more explicit and rational approach to

  7. 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

  8. 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.

  9. 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

  10. 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 ...

  11. 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.

  12. 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,…

  13. 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

  14. 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)

  15. 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.

  16. 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

  17. Association between Serum Phospholipid Fatty Acids and Intraprostatic Inflammation in the Placebo Arm of the Prostate Cancer Prevention Trial.

    Science.gov (United States)

    Nash, Sarah H; Schenk, Jeannette M; Kristal, Alan R; Goodman, Phillis J; Lucia, M Scott; Parnes, Howard L; Thompson, Ian M; Lippman, Scott M; Song, Xiaoling; Gurel, Bora; De Marzo, Angelo; Platz, Elizabeth A

    2015-07-01

    Inflammation may play an etiologic role in prostate cancer. Several dietary factors influence inflammation; studies have shown that long-chain n-3 polyunsaturated fatty acids are anti-inflammatory, whereas n-6 and trans fatty acids are proinflammatory. We evaluated whether serum phospholipid n-3, n-6, and trans fatty acids were associated with intraprostatic inflammation, separately in 191 prostate cancer cases and 247 controls from the placebo arm of the Prostate Cancer Prevention Trial (PCPT). Men without a prostate cancer diagnosis underwent prostate biopsy at trial end, and benign prostate tissue inflammation was evaluated in approximately three biopsy cores per man; this was expressed as no, some, or all cores with inflammation. In controls, serum eicosapentaenoic acid [OR of all cores with inflammation versus none (95% CI), 0.35 (0.14-0.89)] and docosahexaenoic acid [OR (95% CI), 0.42 (0.17-1.02)] were inversely associated with, whereas linoleic acid [OR (95% CI), 3.85 (1.41-10.55)] was positively associated with intraprostatic inflammation. Serum trans fatty acids were not associated with intraprostatic inflammation. No significant associations were observed in cases; however, we could not rule out a positive association with linoleic acid and an inverse association with arachidonic acid. Thus, in the PCPT, we found that serum n-3 fatty acids were inversely, n-6 fatty acids were positively, and trans fatty acids were not associated with intraprostatic inflammation in controls. Although, in theory, inflammation could mediate associations of serum fatty acids with prostate cancer risk, our findings cannot explain the epidemiologic associations observed with n-3 and n-6 fatty acids.

  18. 多臂星形聚乙二醇的合成%Preparation of multi-arm star polyethylene glycol

    Institute of Scientific and Technical Information of China (English)

    张海连; 郭晖; 向清祥

    2012-01-01

    Two carboxyl groups were introduced at the chain end of esterification product derived from the reaction between PEG and succinic anhydride and then, the product reacted with thionyl chloride to prepare CIOC -PEG -COCI. Furthermore, the resultant intermediate reacted with polyols, such as glycerol, pentaerythritol or D-sorbitol, to make three-, four-, or six-arm PEGs, respectively. The ultimate products were characterized by Fourier transform infrared spectroscopy (FTIR) and hydrogen nuclear magnetic resonance (1H-NMR). The number average molecular mass of three-, four-, or six-arm PEGs was 3 794, 4 738, and 6 432, respectively, as measured with the end group titration method. The results indicate that the aforementioned synthesis route is a feasible method to prepare multi-arm star PEG with carboxyl end group.%聚乙二酵(PEG)经与丁二酸酐发生酯化后,在两末端引入羧基,再与氯化亚砜反应得到聚乙二醇二酰氯,此产物再分别与丙三醇、季戊四醇或D-山梨醇等多元醇反应,可分别得到三臂、四臂和六臂星形PEG.用傅里叶变换红外光谱和核磁共振氢谱等对各产物进行了表征,端基分析法得到三臂、四臂和六臂PEG的数均分子量平均值分别为3794,4738,6432,表明采用上述合成路线可成功得到末端为羧基的多臂星形PEG.

  19. Impact of Two Adolescent Pregnancy Prevention Interventions on Risky Sexual Behavior: A Three-Arm Cluster Randomized Control Trial

    Science.gov (United States)

    Cunningham, Michael R.; van Zyl, Michiel A.; Antle, Becky F.; Langley, Cheri N.

    2016-01-01

    Objectives. To test the efficacy of Reducing the Risk (RTR) and Love Notes (LN) on reducing risky sexual behavior among youths yet to experience or cause a pregnancy. Methods. The four dependent variables were ever had sex, condom use, birth control use, and number of sexual partners at 3- and 6-month follow-up in a 3-arm cluster randomized controlled trial of 1448 impoverished youths, aged 14 to 19 years, in 23 community-based organizations in Louisville, Kentucky, from September 2011 through March 2014. Results. At 3 and 6 months, compared with the control condition, youths in RTR reported fewer sexual partners and greater use of birth control. At 6 months, LN participants reported greater use of birth control and condoms, fewer sexual partners, and were less likely to have ever had sex compared with the control condition. Conclusions. We provided additional evidence for the continued efficacy of RTR and the first rigorous study of LN, which embeds sex education into a larger curriculum on healthy relationships and violence prevention. PMID:27689500

  20. 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.

  1. 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...

  2. 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

  3. 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

    Directory of Open Access Journals (Sweden)

    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

  4. Trial Development of a Mobile Feeding Assistive Robotic Arm for People with Physical Disabilities of the Extremities

    Science.gov (United States)

    Uehara, Hideyuki; Higa, Hiroki; Soken, Takashi; Namihira, Yoshinori

    A mobile feeding assistive robotic arm for people with physical disabilities of the extremities has been developed in this paper. This system is composed of a robotic arm, microcontroller, and its interface. The main unit of the robotic arm can be contained in a laptop computer's briefcase. Its weight is 5kg, including two 12-V lead acid rechargeable batteries. This robotic arm can be also mounted on a wheelchair. To verify performance of the mobile robotic arm system, drinking tea task was experimentally performed by two able-bodied subjects as well as three persons suffering from muscular dystrophy. From the experimental results, it was clear that they could smoothly carry out the drinking task, and that the robotic arm could firmly grasp a commercially available 500-ml plastic bottle. The eating task was also performed by the two able-bodied subjects. The experimental results showed that they could eat porridge by using a spoon without any difficulty.

  5. A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax® suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079

    Directory of Open Access Journals (Sweden)

    Franck Annette

    2008-07-01

    Full Text Available Abstract Background Several randomized controlled trials have compared different suture materials and techniques for abdominal wall closure with respect to the incidence of incisional hernias after midline laparotomy and shown that it remains, irrespective of the methods used, considerably high, ranging from 9% to 20%. The development of improved suture materials which would reduce postoperative complications may help to lower its frequency. Design This is a historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety of MonoMax® suture material for abdominal wall closure in 150 patients with primary elective midline incisions. INSECT patients who underwent abdominal closure using Monoplus® and PDS® will serve as historical control group. The incidences of wound infections and of burst abdomen are defined as composite primary endpoints. Secondary endpoints are the frequency of incisional hernias within one year after operation and safety. To ensure adequate comparability in surgical performance and recruitment, the 4 largest centres of the INSECT-Trial will participate. After hospital discharge, the investigators will examine the enrolled patients again at 30 days and at 12 ± 1 months after surgery. Conclusion This historically controlled, single-arm, multi-centre, prospective ISSAAC trial aims to assess whether the use of an ultra-long-lasting absorbable monofilament suture material is safe and efficient. Trial registration NCT005725079

  6. 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

  7. 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.

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

    Science.gov (United States)

    Ang, Kai Keng; Guan, Cuntai; Phua, Kok Soon; Wang, Chuanchu; Zhou, Longjiang; Tang, Ka Yin; Ephraim Joseph, Gopal J; Kuah, Christopher Wee Keong; Chua, Karen Sui Geok

    2014-01-01

    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 min per session. The BCI-HK group received 1 h of BCI coupled with HK intervention, and the HK group received 1 h 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 min of therapist-assisted arm mobilization. The SAT group received 1.5 h 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.

  9. 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.

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

    Science.gov (United States)

    Eldridge, Sandra M; Lancaster, Gillian A; Campbell, Michael J; 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 pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

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

    Directory of Open Access Journals (Sweden)

    Sandra M Eldridge

    Full Text Available 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 pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

  12. 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.

  13. 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 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.

  14. SYNTHESIS AND CHARACTERIZATION OF FOUR-ARMED BLOCK POLY(STYRENE-b-p-NITRO PHENYL METHACRYLATE) PREPARED BY THE ATRP METHOD

    Institute of Scientific and Technical Information of China (English)

    Cai-yuan Pan; Lei Tao; Ye Liu

    2002-01-01

    A novel tetrafunctional initiator, C[CH2O(CH2)3OOCCH(Br)CH3]4 (1), was synthesized through the reaction oftetraol with α-bromopropionyl chloride, and then was used as initiator of atom transfer radical polymerization (ATRP) in thepreparation of 4-armed polystyrene (PSt) with narrow polydispersity. The structure, molecular weight and molecular weightdistribution (MWD) of each arm were studied by 1H-NMR and GPC data of hydrolyzed products of the 4-armed PSt. TheATRP of St using 1/CuBr/bpy as initiator system is of "living" character based on the following evidence: narrow MWD,constant concentration of chain radical during the polymerization, control of molecular weight by the molar ratio of monomerconsumed to 1. The 4-armed poly(St-b-p-nitrophenyl methacrylate) [poly(St-b-NPMA)] was prepared by the ATRP ofNPMA using 4-armed PSt with terminal bromine as the initiator, and characterized by FT-IR, 1H-NMR spectra and GPCcurves. The micelles with PSt as core, and PNPMA as shell were formed by dropping DMSO into a solution of 4-armedpoly(St-b-NPMA) in DMF, as proved by laser light scatter (LLS) method.

  15. 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 ...

  16. Two Oral Midazolam Preparations in Pediatric Dental Patients: A Prospective Randomised Clinical Trial

    Directory of Open Access Journals (Sweden)

    Katayoun Salem

    2015-01-01

    Full Text Available Pharmacological sedation is an alternative behavior management strategy in pediatric dentistry. The aim of this study was to compare the behavioral and physiologic effects of “commercially midazolam syrup” versus “orally administered IV midazolam dosage form (extemporaneous midazolam (EF” in uncooperative pediatric dental patients. Eighty-eight children between 4 to 7 years of age received 0.2–0.5 mg/kg midazolam in this parallel trial. Physiologic parameters were recorded at baseline and every 15 minutes. Behavior assessment was conducted objectively by Houpt scale throughout the sedation and North Carolina at baseline and during injection and cavity preparation. No significant difference in behavior was noted by Houpt or North Carolina scale. Acceptable behavior (excellent, very good, and good was observed in 90.9% of syrup and 79.5% of EF subjects, respectively. Physiological parameters remained in normal range without significant difference between groups and no adverse effect was observed. It is concluded that EF midazolam preparation can be used as an acceptable alternative to midazolam syrup.

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

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    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.

  18. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  20. 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

    Directory of Open Access Journals (Sweden)

    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

  1. 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

  2. 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

  3. 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

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

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    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.

  5. 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

  6. 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

  7. Preparation of Well-Defined Propargyl-Terminated Tetra-Arm Poly(N-isopropylacrylamides and Their Click Hydrogels Crosslinked with β-cyclodextrin

    Directory of Open Access Journals (Sweden)

    Jianquan Wang

    2016-03-01

    Full Text Available As an important class of reversible deactivation radical polymerization (RDRP, reversible addition fragmentation chain transfer (RAFT polymerization has attracted great attention attributed to its facile and flexible features to prepare well-defined polymers with different complex structures. In addition, the combination of RAFT with click chemistry provides more effective strategies to fabricate advanced functional materials. In this work, a series of temperature responsive tetra-arm telechelic poly(N-isopropylacrylamides (PNIPAs with propargyl end groups were prepared for the first time through RAFT and subsequent aminolysis/Michael addition modification. The temperature sensitivities of their aqueous solutions were researched via turbidity measurement. It was found that the phase transition temperature of obtained PNIPAs increased with their molecular weights ascribed to their distinctions in the hydrophobic/hydrophilic balance. Subsequently, β-cyclodextrin (β-CD functionalized with azide moieties was used to crosslink the prepared propargyl-terminated tetra-arm PNIPAs through click chemistry, fabricating corresponding hydrogels with thermoresponse. Similar to their precursors, the hydrogels demonstrated the same dependence of volume phase transition temperature (VPTT on their molecular weights. In addition, the incorporation of β-CD and the residual groups besides crosslinking may provide a platform for imparting additional functions such as inclusion and adsorption as well as further functionalization.

  8. 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.

  9. 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

  10. 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.

  11. 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

  12. Role of blood pressure and other variables in the differential cardiovascular event rates noted in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA)

    DEFF Research Database (Denmark)

    Poulter, Neil R; Wedel, Hans; Dahlöf, Björn;

    2005-01-01

    Results of the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA) show significantly lower rates of coronary and stroke events in individuals allocated an amlodipine-based combination drug regimen than in those allocated an atenolol-based combination drug regimen (HR...... 0.86 and 0.77, respectively). Our aim was to assess to what extent these differences were due to significant differences in blood pressures and in other variables noted after randomisation....

  13. 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...

  14. 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

  15. Reducing substance involvement in college students: a three-arm parallel-group randomized controlled trial of a computer-based intervention.

    Science.gov (United States)

    Christoff, Adriana de Oliveira; Boerngen-Lacerda, Roseli

    2015-06-01

    The prevalence of alcohol and other drug use is high among college students. Reducing their consumption will likely be beneficial for society as a whole. Computer and web-based interventions are promising for providing behaviorally based information. The present study compared the efficacy of three interventions (computerized screening and motivational intervention [ASSIST/MBIc], non-computerized screening and motivational intervention [ASSIST/MBIi], and screening only [control]) in college students in Curitiba, Brazil. A convenience sample of 458 students scored moderate and high risk on the ASSIST. They were then randomized into the three arms of the randomized controlled trial (ASSIST/MBIc, ASSIST/MBIi [interview], and assessment-only [control]) and assessed at baseline and 3 months later. The ASSIST involvement scores decreased at follow-up compared with baseline in the three groups, suggesting that any intervention is better than no intervention. For alcohol, the specific involvement scores decreased to a low level of risk in the three groups and the MBIc group showed a positive outcome compared with control, and the scores for each question were reduced in the two intervention groups compared to baseline. For tobacco, involvement scores decreased in the three groups, but they maintained moderate risk. For marijuana, a small positive effect was observed in the ASSIST/MBIi and control groups. The ASSIST/MBIc may be a good alternative to interview interventions because it is easy to administer, students frequently use such computer-based technologies, and individually tailored content can be delivered in the absence of a counselor. PMID:25679364

  16. 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...

  17. 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.

  18. 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

    , on 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...

  19. 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

  20. 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

  1. 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

  2. Trial Preparation of Composite Raw Mat Glaze%复合生料无光釉的研制

    Institute of Scientific and Technical Information of China (English)

    吴大军

    2011-01-01

    This paper mainly describes the trial preparation of composite raw mat glaze,and discuss the influence of oxides such as MgO,CaO,ZnO,Al_2O_3,SiO_2 and the ratio Al_2O_3/SiO_2,the firing system as well as other on the mat glaze.%叙述了复合生料釉的研制过程,讨论了MgO、CaO、ZnO、Al_2O_3、SiO_2等氧化物及Al_2O_3/SiO_2比、烧成制度和其他因素对无光釉的影响。

  3. [Clinical trial of a Plantago major preparation in the treatment of chronic bronchitis].

    Science.gov (United States)

    Matev, M; Angelova, I; Koĭchev, A; Leseva, M; Stefanov, G

    1982-01-01

    Plantago major, according to literature data, has expectorant, antiphlogistic, pain-relieving effect. The experimental studies confirmed a spastic effect upon the smooth musculature of bronchi as well. Twenty five patients with chronic bronchitis were examined, with or without spastic character, with light and moderately severe deviations in ventilation indices. The treatment period was 25-30 days. A rapid effect on subjective complaints and objective findings was obtained in 80 per cent. Some indices of external respiration were favourably affected. The preparation is with a good tolerance, with no toxic effect on gastrointestinal tract, liver, kidneys, hemopoiesis. PMID:7101883

  4. 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.

  5. 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.

  6. 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)

    Schabath, Matthew B; 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 < 0.001). Moreover, PFS and OS were significantly lower for SDLC3/SDLC4 compared to SDLC1/SDLC2 (P < 0.004; P < 0.002, respectively). The findings were consistent when stratified by stage and histology

  7. [Clinical trial of a topical preparation containing urea, sunflower oil, evening primrose oil, wheat germ oil and sodium pyruvate, in several hyperkeratotic skin conditions].

    Science.gov (United States)

    Ferrando, J

    1986-01-01

    A topical clinical trial with preparations containing urea and sodium pyruvate has been made. It was used for diverse hyperkeratotic skin conditions (psoriasis, xerosis, pityriasis rubra pilaris, stuccokeratosis, seborrheic dermatitis, stasis dermatitis, pityriasis lichenoides chronica). A month later a clinical improvement was evident in all cases except in pityriasis lichenoides.

  8. 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

  9. A self-management program for employees with complaints of the arm, neck, or shoulder (CANS): study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Hutting, N.; Staal, J.B.; Heerkens, Y.F.; Engels, J.A.; Nijhuis-Van der Sanden, M.W.G.

    2013-01-01

    BACKGROUND: Complaints of the arm, neck, or shoulder (CANS) have a multifactorial origin and cause considerable work problems, including decreased work productivity, sickness absence, and, ultimately, job loss. There is a need for intervention programs for people with CANS. Self-management is an app

  10. 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

  11. 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

  12. 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

  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

    . 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...... hospitalization or death from any cause. The study has completed patient enrollment in December 2006 and is expected to end follow-up 1 year later. Conclusion: ATHENA will be the largest efficacy and safety trial of dronedarone, a multichannel blocker compound with properties from class I, II, III, and IV...

  14. 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.

  15. 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...

  16. 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

  17. 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.

  18. 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.

  19. Multiple applications of flurbiprofen and chlorhexidine chips in patients with chronic periodontitis: a randomized, double blind, parallel, 2-arms clinical trial

    Science.gov (United States)

    Machtei, Eli E; Hirsh, Ilan; Falah, Maher; Shoshani, Eyal; Avramoff, Avi; Penhasi, Adel

    2011-01-01

    Aim The aim of the present randomized, double blind, parallel, 2-arm clinical study was to examine the safety and efficacy of frequent applications of chlorhexidine chip (CHX) and flurbiprofen chip (FBP) in patients with chronic periodontitis. Methods Sixty patients were randomized into CHX and FBP groups. Following OHI and scaling and root planing (SRP), baseline pocket depth (PD) measurements, gingival recession and bleeding on probing (BOP) were performed and repeated at week 4 and 8. The assigned chip was placed at weeks 0, 1, 2, 3, 5, 7. Results Mean PD reduction in the CHX group was 2.08 mm (7.17 to 5.09, p < 0.0001). Mean PD reduction in the FBP group was 2.27 mm (6.72 to 4.45, p < 0.0001). Ninety-seven percentage and 95% of these sites exhibited PD reduction ≥1 mm, while 38% and 34% of the sites exhibited PD ≥3 mm (FBP and CHX, respectively). Clinical attachment level gain (1.66 and 1.95 mm, respectively) was statistically significant (p < 0.0001). Baseline BOP dropped from 98% and 100% to 24% and 30% for the CHX and FBP groups, respectively (p < 0.0001). Conclusion Frequent applications of CHX and FBP chips resulted in a significant improvement in the periodontal condition in these sites. Furthermore studies will be required to compare this new treatment regimen to SRP or SRP with single chip application. PMID:22092475

  20. Health education through analogies: preparation of a community for clinical trials of a vaccine against hookworm in an endemic area of Brazil.

    Directory of Open Access Journals (Sweden)

    Maria Flavia Gazzinelli

    Full Text Available BACKGROUND: Obtaining informed consent for clinical trials is especially challenging when working in rural, resource-limited areas, where there are often high levels of illiteracy and lack of experience with clinical research. Such an area, a remote field site in the northeastern part of the state of Minas Gerais, Brazil, is currently being prepared for clinical trials of experimental hookworm vaccines. This study was conducted to assess whether special educational tools can be developed to increase the knowledge and comprehension of potential clinical trial participants and thereby enable them to make truly informed decisions to participate in such research. METHODOLOGY/PRINCIPAL FINDINGS: An informational video was produced to explain the work of the research team and the first planned hookworm vaccine trial, using a pedagogical method based on analogies. Seventy-two adults living in a rural community of Minas Gerais were administered a structured questionnaire that assessed their knowledge of hookworm, of research and of the planned hookworm vaccine trial, as well as their attitudes and perceptions about the researchers and participation in future vaccine trials. The questionnaire was administered before being shown the educational video and two months after and the results compared. After viewing the video, significant improvements in knowledge related to hookworm infection and its health impact were observed: using a composite score combining related questions for which correct answers were assigned a value of 1 and incorrect answers a value of 0, participants had a mean score of 0.76 post-video compared to 0.68 pre-video (p = 0.0001. Similar improvements were seen in understanding the purpose of vaccination and the possible adverse effects of an experimental vaccine. Although 100% of participants expressed a positive opinion of the researchers even before viewing the film and over 90% said that they would participate in a hookworm vaccine

  1. The providing resources to enhance African American patients’ readiness to make decisions about kidney disease (PREPARED study: protocol of a randomized controlled trial

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    Ephraim Patti L

    2012-10-01

    Full Text Available Abstract Background Living related kidney transplantation (LRT is underutilized, particularly among African Americans. The effectiveness of informational and financial interventions to enhance informed decision-making among African Americans with end stage renal disease (ESRD and improve rates of LRT is unknown. Methods/design We report the protocol of the Providing Resources to Enhance African American Patients’ Readiness to Make Decisions about Kidney Disease (PREPARED Study, a two-phase study utilizing qualitative and quantitative research methods to design and test the effectiveness of informational (focused on shared decision-making and financial interventions to overcome barriers to pursuit of LRT among African American patients and their families. Study Phase I involved the evidence-based development of informational materials as well as a financial intervention to enhance African American patients’ and families’ proficiency in shared decision-making regarding LRT. In Study Phase 2, we are currently conducting a randomized controlled trial in which patients with new-onset ESRD receive 1 usual dialysis care by their nephrologists, 2 the informational intervention (educational video and handbook, or 3 the informational intervention in addition to the option of participating in a live kidney donor financial assistance program. The primary outcome of the randomized controlled trial will include patients’ self-reported rates of consideration of LRT (including family discussions of LRT, patient-physician discussions of LRT, and identification of a LRT donor. Discussion Results from the PREPARED study will provide needed evidence on ways to enhance the decision to pursue LRT among African American patients with ESRD. Trial registration ClinicalTrials.gov NCT01439516

  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. 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

  4. Treatment Extension of Pegylated Interferon Alpha and Ribavirin Does Not Improve SVR in Patients with Genotypes 2/3 without Rapid Virological Response (OPTEX Trial: A Prospective, Randomized, Two-Arm, Multicentre Phase IV Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Benjamin Heidrich

    Full Text Available Although sofosbuvir has been approved for patients with genotypes 2/3 (G2/3, many parts of the world still consider pegylated Interferon alpha (P and ribavirin (R as standard of care for G2/3. Patients with rapid virological response (RVR show response rates >80%. However, SVR (sustained virological response in non-RVR patients is not satisfactory. Longer treatment duration may be required but evidence from prospective trials are lacking. A total of 1006 chronic HCV genotype 2/3 patients treated with P/R were recruited into a German HepNet multicenter screening registry. Of those, only 226 patients were still HCV RNA positive at week 4 (non-RVR. Non-RVR patients with ongoing response after 24 weeks P-2b/R qualified for OPTEX, a randomized trial investigating treatment extension of additional 24 weeks (total 48 weeks, Group A or additional 12 weeks (total 36 weeks, group B of 1.5 μg/kg P-2b and 800-1400 mg R. Due to the low number of patients without RVR, the number of 150 anticipated study patients was not met and only 99 non-RVR patients (n=50 Group A, n=49 Group B could be enrolled into the OPTEX trial. Baseline factors did not differ between groups. Sixteen patients had G2 and 83 patients G3. Based on the ITT (intention-to-treat analysis, 68% [55%; 81%] in Group A and 57% [43%; 71%] in Group B achieved SVR (p= 0.31. The primary endpoint of better SVR rates in Group A compared to a historical control group (SVR 70% was not met. In conclusion, approximately 23% of G2/3 patients did not achieve RVR in a real world setting. However, subsequent recruitment in a treatment-extension study was difficult. Prolonged therapy beyond 24 weeks did not result in higher SVR compared to a historical control group.ClinicalTrials.gov NCT00803309.

  5. Usage and Dose Response of a Mobile Acceptance and Commitment Therapy App: Secondary Analysis of the Intervention Arm of a Randomized Controlled Trial

    Science.gov (United States)

    Lappalainen, Raimo; Välkkynen, Pasi; Sairanen, Essi; Lappalainen, Päivi; Karhunen, Leila; Peuhkuri, Katri; Korpela, Riitta; Kolehmainen, Marjukka; Ermes, Miikka

    2016-01-01

    Background Mobile phone apps offer a promising medium to deliver psychological interventions. A mobile app based on Acceptance and Commitment Therapy (ACT) was developed and studied in a randomized controlled trial (RCT). Objective To study usage metrics of a mobile ACT intervention and dose-response relationship between usage and improvement in psychological flexibility. Methods An RCT was conducted to investigate the effectiveness of different lifestyle interventions for overweight people with psychological stress. This paper presents a secondary analysis of the group that received an 8-week mobile ACT intervention. Most of the analyzed 74 participants were female (n=64, 86%). Their median age was 49.6 (interquartile range, IQR 45.4-55.3) years and their mean level of psychological flexibility, measured with the Acceptance and Action Questionnaire II, was 20.4 (95% confidence interval 18.3-22.5). Several usage metrics describing the intensity of use, usage of content, and ways of use were calculated. Linear regression analyses were performed to study the dose-response relationship between usage and the change in psychological flexibility and to identify the usage metrics with strongest association with improvement. Binary logistic regression analyses were further used to assess the role of usage metrics between those who showed improvement in psychological flexibility and those who did not. In addition, associations between usage and baseline participant characteristics were studied. Results The median number of usage sessions was 21 (IQR 11.8-35), the number of usage days was 15 (IQR 9.0-24), and the number of usage weeks was 7.0 (IQR 4.0-8.0). The participants used the mobile app for a median duration of 4.7 (IQR 3.2-7.2) hours and performed a median of 63 (IQR 46-98) exercises. There was a dose-response relationship between usage and the change in psychological flexibility. The strongest associations with psychological flexibility (results adjusted with gender

  6. Transfusion of pooled buffy coat platelet components prepared with photochemical pathogen inactivation treatment: the euroSPRITE trial

    NARCIS (Netherlands)

    D.J. van Rhenen (Dirk Jan); S. Marblie (Stephane); M. Laforet (Michel); K. Davis (Kathryn); M. Conlan (Maureen); B. Lioure (Bruno); H. Gulliksson (Hans); J.P. Cazenave; P. Metzel (Peyton); D. Pamphilon (Derwood); L. Corash (Laurence); J. Flament (Jocelyne); P. Ljungman (Per); H. Kluter; H. Vermeij (Hans); V. Mayaudon (Veronique); L. Lin (Lily); M.C. Kappers-Klunne (Mies); D. Buchholz (Don); G.E. de Greef (Georgine)

    2003-01-01

    textabstractA nucleic acid-targeted photochemical treatment (PCT) using amotosalen HCl (S-59) and ultraviolet A (UVA) light was developed to inactivate viruses, bacteria, protozoa, and leukocytes in platelet components. We conducted a controlled, randomized, double-blinded trial in thrombocytopenic

  7. 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.

  8. SmartPill® as an objective parameter for determination of severity and duration of postoperative ileus: study protocol of a prospective, two-arm, open-label trial (the PIDuSA study)

    Science.gov (United States)

    Vilz, Tim O; Pantelis, Dimitrios; Lingohr, Philipp; Fimmers, Rolf; Esmann, Anke; Randau, Thomas; Kalff, Jörg C; Coenen, Martin; Wehner, Sven

    2016-01-01

    Introduction Postoperative ileus (POI) is a frequent complication after abdominal surgery (AS). Until today, neither a prophylaxis nor an evidence-based therapy exists. This originates from the absence of objective parameters evaluating the severity and duration of POI resulting in clinical trials of modest quality. The SmartPill®, a capsule which frequently measures pH value, temperature and intraluminal pressure after swallowing, offers an elegant option for analysing gastrointestinal (GI) transit times and smooth muscle activity in vivo. As the use in patients in the first months after AS is not covered by the marketing authorisation, we aim to investigate the safety and feasibility of the SmartPill® immediately after surgery. Additionally, we analyse the influence of prokinetics and laxatives as well as standardised physiotherapy on postoperative bowel contractility, as scientific evidence of its effects is still lacking. Methods and analysis The PIDuSA study is a prospective, single-centre, two-arm, open-label trial. The SmartPill® will be applied to 55 patients undergoing AS having a high risk for POI and 10 patients undergoing extra-abdominal surgery rarely developing POI. The primary objective is the safety of the SmartPill® in patients after surgery on the basis of adverse device effects/serious adverse device effects (ADE/SADE). The sample size suggests that events with a probability of 3% could be seen with a certainty of 80% for at least once in the sample. Secondary objective is the analysis of postoperative intestinal activity in the GI tract in both groups. Furthermore, clinical signs of bowel motility disorders will be correlated to the data measured by the SmartPill® to evaluate its significance as an objective parameter for assessing POI severity. Additionally, effects of prokinetics, laxatives and physiotherapy on postoperative peristaltic activity recorded by the SmartPill® will be analysed. Ethics and dissemination The protocol was

  9. A Single-Arm, Proof-Of-Concept Trial of Lopimune (Lopinavir/Ritonavir as a Treatment for HPV-Related Pre-Invasive Cervical Disease.

    Directory of Open Access Journals (Sweden)

    Lynne Hampson

    Full Text Available Cervical cancer is the most common female malignancy in the developing nations and the third most common cancer in women globally. An effective, inexpensive and self-applied topical treatment would be an ideal solution for treatment of screen-detected, pre-invasive cervical disease in low resource settings.Between 01/03/2013 and 01/08/2013, women attending Kenyatta National Hospital's Family Planning and Gynaecology Outpatients clinics were tested for HIV, HPV (Cervista® and liquid based cervical cytology (LBC-ThinPrep®. HIV negative women diagnosed as high-risk HPV positive with high grade squamous intraepithelial lesions (HSIL were examined by colposcopy and given a 2 week course of 1 capsule of Lopimune (CIPLA twice daily, to be self-applied as a vaginal pessary. Colposcopy, HPV testing and LBC were repeated at 4 and 12 weeks post-start of treatment with a final punch biopsy at 3 months for histology. Primary outcome measures were acceptability of treatment with efficacy as a secondary consideration.A total of 23 women with HSIL were treated with Lopimune during which time no adverse reactions were reported. A maximum concentration of 10 ng/ml of lopinavir was detected in patient plasma 1 week after starting treatment. HPV was no longer detected in 12/23 (52.2%, 95%CI: 30.6-73.2%. Post-treatment cytology at 12 weeks on women with HSIL, showed 14/22 (63.6%, 95%CI: 40.6-82.8% had no dysplasia and 4/22 (18.2%, 95%CI: 9.9-65.1% were now low grade demonstrating a combined positive response in 81.8% of women of which 77.8% was confirmed by histology. These data are supported by colposcopic images, which show regression of cervical lesions.These results demonstrate the potential of Lopimune as a self-applied therapy for HPV infection and related cervical lesions. Since there were no serious adverse events or detectable post-treatment morbidity, this study indicates that further trials are clearly justified to define optimal regimes and the overall

  10. 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

  11. 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.

  12. 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.

  13. 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

  14. 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

  15. 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.

  16. 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.

  17. The FOCUS trial

    DEFF Research Database (Denmark)

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

    2015-01-01

    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 treatment...

  18. Looking for the new preparations for antibacterial therapy III. New antimicrobial agents from the quinolones group in clinical trials.

    Science.gov (United States)

    Karpiuk, Izabela; Tyski, Stefan

    2013-01-01

    There is an essential need for searching for the new compounds effective in the treatment of infections caused by multidrug-resistant bacteria. This paper is the third part of a series associated with the exploration of new antibacterial agents and it discusses the compounds belonging to the group of quinolones and substances possessing a hybrid structure composed of the quinolone molecule and other compounds. Eleven new substances at the stage of clinical trials are presented. Three of them belong to the group of non-fluorinated quinolone (nemonoxacin, ozenoxacin and KRP-AM 1977X), while six are the quinolones containing fluorine atom at 6 position of the carbon atom in the quinoline ring (zabofloxacin, finafloxacin, delafloxacin, JNJ-Q2, WCK771 and KPI-10). The remaining two compounds possess a hybrid construction composed of the quinolone structure and other molecules (cadazolid and CBR-2092). There is a chance in the near future, that the presented compounds can extend the range of existing antibacterial drugs and provide an alternative to currently available medicinal products.

  19. 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

  20. 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)

  1. The S228P mutation prevents in vivo and in vitro IgG4 Fab-arm exchange as demonstrated using a combination of novel quantitative immunoassays and physiological matrix preparation.

    Science.gov (United States)

    Silva, John-Paul; Vetterlein, Olivia; Jose, Joby; Peters, Shirley; Kirby, Hishani

    2015-02-27

    Human immunoglobulin G isotype 4 (IgG4) antibodies (Abs) are potential candidates for immunotherapy when reduced effector functions are desirable. IgG4 Abs are dynamic molecules able to undergo a process known as Fab arm exchange (FAE). This results in functionally monovalent, bispecific antibodies (bsAbs) with unknown specificity and hence, potentially, reduced therapeutic efficacy. IgG4 FAE is suggested to be an important biological mechanism that provides the basis for the anti-inflammatory activity attributed to IgG4 Abs. To date, the mechanism of FAE is not entirely understood and studies measuring FAE in ex vivo matrices have been hampered by the presence and abundance of endogenous IgG4 wild-type (WT) Abs. Using representative humanized WT IgG4 monoclonal Abs, namely, anti-IL-6 and anti-TNF, and a core-hinge stabilized serine 228 to proline (S228P) anti-IL-6 IgG4 mutant, it is demonstrated for the first time how anti-IgG4 affinity chromatography can be used to prepare physiologically relevant matrices for assessing and quantifying FAE. A novel method for quantifying FAE using a single MSD immunoassay is also reported and confirms previous findings that, dependent on the redox conditions, the S228P mutation can prevent IgG4 FAE to undetectable levels both in vitro and in vivo. Together, the findings and novel methodologies will allow researchers to monitor and quantify FAE of their own IgG4 molecules in physiologically relevant matrices.

  2. 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...

  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. 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.

  5. Effect of swim speed on leg-to-arm coordination in unilateral arm amputee front crawl swimmers.

    Science.gov (United States)

    Osborough, Conor; Daly, Daniel; Payton, Carl

    2015-01-01

    The aim of this study was to examine the effect of swimming speed on leg-to-arm coordination in competitive unilateral arm amputee front crawl swimmers. Thirteen well-trained swimmers were videotaped underwater during three 25-m front crawl trials (400 m, 100 m and 50 m pace). The number, duration and timing of leg kicks in relation to arm stroke phases were identified by video analysis. Within the group, a six-beat kick was predominantly used (n = 10) although some swimmers used a four-beat (n = 2) or eight-beat kick (n = 1). Swimming speed had no significant effect on the relative duration of arm stroke and leg kick phases. At all speeds, arm stroke phases were significantly different (P amputee swimmers functionally adapt their motor organisation to swim front crawl.

  6. 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

  7. 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...

  8. 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)、

  9. 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.

  10. 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.

  11. 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

  12. 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.

  13. 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 ...

  14. 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

  15. 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.

  16. 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.

  17. 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

  18. Phoenix Stretches its Arm

    Science.gov (United States)

    2008-01-01

    [figure removed for brevity, see original site] Click on image for animation The Phoenix spacecraft is scheduled to begin raising its robotic arm up and out of its stowed configuration on the third Martian day, or Sol 3 (May 28, 2008) of the mission. This artist's animation, based on engineering models, shows how Phoenix will accomplish this task. First, its wrist actuator will rotate, releasing its launch-restraint pin. Next, the forearm moves up, releasing the elbow launch-restraint pin. The elbow will then move up and over in small steps, a process referred to as 'staircasing.' This ensures that the arm's protective biobarrier wrap, now unpeeled and lying to the side of the arm, will not get in the way of the arm's deployment. The arm is scheduled to straighten all the way out on Sol 4 (May 29, 2008), after engineers have reviewed images and telemetry data from the spacecraft showing that the biobarrier material has been cleared. 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.

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

    Directory of Open Access Journals (Sweden)

    Mohammed T. Abbas

    2014-01-01

    Full Text Available 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.

  20. 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

  1. The COLOFOL trial

    DEFF Research Database (Denmark)

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

    2016-01-01

    in tumor location and stage distribution, with 5.6% more patients in the randomized group having colon cancer and 6.7% more patients having stage II disease. CONCLUSION: Patients in the two study arms were not only demographically similar, but also similar to nonincluded eligible patients, apart from stage......INTRODUCTION: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL...... population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24...

  2. 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.

  3. 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...

  4. 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

  5. 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.

  6. 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:…

  7. 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

  8. 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....

  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. 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 ...

  11. Silexan, an orally administered Lavandula oil preparation, is effective in the treatment of 'subsyndromal' anxiety disorder: a randomized, double-blind, placebo controlled trial.

    Science.gov (United States)

    Kasper, Siegfried; Gastpar, Markus; Müller, Walter E; Volz, Hans-Peter; Möller, Hans-Jürgen; Dienel, Angelika; Schläfke, Sandra

    2010-09-01

    This study was performed to investigate the anxiolytic efficacy of silexan, a new oral lavender oil capsule preparation, in comparison to placebo in primary care. In 27 general and psychiatric practices 221 adults suffering from anxiety disorder not otherwise specified (Diagnostic and Statistical Manual of Mental disorders-IV 300.00 or International Statistical Classification of Diseases and Related Health Problems, Tenth revision F41.9) were randomized to 80 mg/day of a defined, orally administered preparation from Lavandula species or placebo for 10 weeks with visits every 2 weeks. A Hamilton Anxiety Scale (HAMA) total score >or=18 and a total score >5 for the Pittsburgh Sleep Quality Index (PSQI) were required. The primary outcome measures were HAMA and PSQI total score decrease between baseline and week 10. Secondary efficacy measures included the Clinical Global Impressions scale, the Zung Self-rating Anxiety Scale, and the SF-36 Health Survey Questionnaire. Patients treated with silexan showed a total score decrease by 16.0+/-8.3 points (mean+/-SD, 59.3%) for the HAMA and by 5.5+/-4.4 points (44.7%) for the PSQI compared to 9.5+/-9.1 (35.4%) and 3.8+/-4.1 points (30.9%) in the placebo group (Poil preparation had a significant beneficial influence on quality and duration of sleep and improved general mental and physical health without causing any unwanted sedative or other drug specific effects. Lavandula oil preparation silexan is both efficacious and safe for the relief of anxiety disorder not otherwise specified. It has a clinically meaningful anxiolytic effect and alleviates anxiety related disturbed sleep.

  12. 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...

  13. 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

  14. 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...

  15. An Open-Label, Single-Arm, Phase 2 Trial of the Polo-Like Kinase Inhibitor Volasertib (BI 6727) in Patients With Locally Advanced or Metastatic Urothelial Cancer

    Science.gov (United States)

    Stadler, Walter M.; Vaughn, David J.; Sonpavde, Guru; Vogelzang, Nicholas J.; Tagawa, Scott T.; Petrylak, Daniel P.; Rosen, Peter; Lin, Chia-Chi; Mahoney, John; Modi, Sanjiv; Lee, Peter; Ernstoff, Marc S.; Su, Wu-Chou; Spira, Alexander; Pilz, Korinna; Vinisko, Richard; Schloss, Charles; Fritsch, Holger; Zhao, Charles; Carducci, Michael A.

    2015-01-01

    BACKGROUND Polo-like kinases (Plks) control multiple steps during the cell cycle, and Plk1 is overexpressed in urothelial cancer (UC). Volasertib (BI 6727), a Plk inhibitor, has demonstrated antitumor activity in several malignancies, including UC. In this phase 2 trial, the authors investigated volasertib as a second-line treatment in advanced/metastatic UC. METHODS Patients who progressed within 2 years of 1 prior chemotherapy regimen received 300 mg volasertib on day 1 every 3 weeks. The dose was escalated to 350 mg in cycle 2 if volasertib was tolerated in cycle 1. The primary endpoint was tumor response, which was assessed every 6 weeks; secondary endpoints were progression-free survival, overall survival, duration of response, safety, and pharmacokinetics. RESULTS Fifty patients were enrolled, and the median patient age was 68.5 years (range, 52-83 years). All patients had received prior platinum, 94% of patients had relapsed ≤2 years after prior therapy, 36% had liver metastases, and 54% had lung metastases. The median number of treatment cycles was 2 (range, 1-27 treatment cycles), and 23 patients were dose escalated at cycle 2. Seven patients (14%) had a partial response, 13 (26%) had stable disease, and 30 (60%) progressed within 6 weeks. The median response duration was 41 weeks (range, 29.1-77.3 weeks). The median progression-free survival was 1.4 months, and the median overall survival was 8.5 months. The most frequent grade 3 and 4 adverse events were neutropenia (28%), thrombocytopenia (20%), and anemia (16%). No cumulative toxicity was observed. CONCLUSIONS Volasertib as second-line treatment for advanced/metastatic UC had an acceptable safety profile but demonstrated insufficient antitumor activity for further evaluation as a monotherapy. PMID:24339028

  16. 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...

  17. 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

  18. ARM User Survey Report

    Energy Technology Data Exchange (ETDEWEB)

    Roeder, LR

    2010-06-22

    The objective of this survey was to obtain user feedback to, among other things, determine how to organize the exponentially growing data within the Atmospheric Radiation Measurement (ARM) Climate Research Facility, and identify users’ preferred data analysis system. The survey findings appear to have met this objective, having received approximately 300 responses that give insight into the type of work users perform, usage of the data, percentage of data analysis users might perform on an ARM-hosted computing resource, downloading volume level where users begin having reservations, opinion about usage if given more powerful computing resources (including ability to manipulate data), types of tools that would be most beneficial to them, preferred programming language and data analysis system, level of importance for certain types of capabilities, and finally, level of interest in participating in a code-sharing community.

  19. 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.

  20. 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

  1. 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 ...

  2. Safety and efficacy trial of adipose-tissue derived oral preparation V-6 Immunitor (V-6: results of open-label, two-month, follow-up study

    Directory of Open Access Journals (Sweden)

    Jirathitikal Vichai

    2010-02-01

    Full Text Available Abstract Background Chronic inflammations, atherosclerosis and obesity, are major risk factors for cardiovascular diseases. Immune modulation of the inflammatory response has shown promise in animal models of atherogenesis and metabolic disease. Tableted dietary supplement, V-6, containing pooled antigens derived from pig adipose tissue has been administered daily to 12 volunteers for 2 months. Results No significant changes were observed in liver ALT and AST enzymes, i.e., 28 vs 23.8 IU and 22.6 vs 24.8 IU, with p = 0.07 and p = 0.49, respectively. Creatinine decreased; 0.88 vs 0.84 mg/dL (p = 0.05 while BUN moved upward; 14.5 vs 17.5 mg/dL (p = 0.01, but both values remained within normal range. Blood glucose remained within normal range; 96.1 vs 101.1 mg/dL (p = 0.04. Complete blood cell analysis has not revealed any change except slight increase in hemoglobin; 13.13 to 13.96 g/dL (p = 0.0002; hematocrit and red blood cells count 40.3 to 42.3% (p = 0.02 and 5.15 to 5.35 × 106 cells/mm3 (p = 0.03 respectively. Blood pressure systolic and diastolic values were not affected, i.e., 116.1 vs 116.3 (p = 0.12 and 76.8 vs 76.6 (p = 0.99. Body weight and body mass index (BMI remained same; 66.4 vs 66.3 kg (p = 0.47 and 25.7 vs 25.6 kg/m2 (p = 0.2. Body fat deposit indices, such as abdomen; mid-arm; and thigh circumferences declined by 3.5 cm (p = 0.008; 1.2 cm (p = 0.004; and 3.0 cm (p = 0.0007 respectively. The total cholesterol and LDL levels did not change; 195.5 vs 195.1 (-0.2%; p = 0.8 and 113.4 vs 120.3 (6.1%; p = 0.08 respectively. Triglycerides have been reduced but not statistically significant; 168.1 vs 118 mg/dL (-29.8%; p = 0.2. In contrast, HDL content had risen by 29.7% from 39.4 to 51.1 mg/dL in all 12 patients (p = 0.000003. TG/HDL ratio - a marker of insulin resistance - was reduced from 4.78 to 2.56 (-46.5%; p = 0.04. Conclusions These results demonstrate that V-6 is safe and has a potential as an anti-atherogenic and overweight

  3. 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

  4. 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 C(n)-2TTNs (n = 6, 8, and 10) have been developed based on the results of theoretical calculation-inspired investigation. A hole mobility for amorphous C(n)-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 C(n)-2TTNs the mobilities become smaller as a consequence of a decrease in transfer integral values. C(n)-2TTNs are synthesized in a microflow reactor through photoreactions of the corresponding precursors. C(n)-2TTNs are then utilized in the fabrication of organic field-effect transistors (OFETs). Although spin-coated thin films of C(n)-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

  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. 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.

  7. An Intervention To Reduce Postpartum Depressive Symptoms: A Randomized Controlled Trial

    Science.gov (United States)

    Howell, Elizabeth A; Bodnar-Deren, Susan; Balbierz, Amy; Loudon, Holly; Mora, Pablo A.; Zlotnick, Caron; Wang, Jason; Leventhal, Howard

    2013-01-01

    Depressive symptoms and depression are a common complication of childbirth and a growing body of literature suggests that there are modifiable factors associated with their occurrence. We developed a behavioral educational intervention targeting these factors and successfully reduced postpartum depressive symptoms in a randomized trial among low-income black and Latina women. We now report results of 540 predominantly white, high income mothers in a second randomized trial. Mothers in the intervention arm received a 2-step intervention that prepared and educated mothers about modifiable factors associated with postpartum depressive symptoms (e.g., physical symptoms, low self-efficacy), bolstered social support, and enhanced management skills. The control arm received enhanced usual care. Participants were surveyed prior to randomization, 3-weeks, 3-months, and 6-months postpartum. Depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS of 10 or greater). Prevalence of depressive symptoms postpartum were unexpectedly low precluding detection of difference in rates of depressive symptoms among intervention vs. enhanced usual care post hospitalization: 3-weeks (6.0 % vs. 5.6%, p=.83), 3-months (5.1% vs. 6.5%, p=.53) and 6-months (3.6% vs. 4.6%, p=.53). PMID:24019052

  8. 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.

  9. 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.

  10. Design and experimental testing of the OctArm soft robot manipulator

    Science.gov (United States)

    Grissom, Michael D.; Chitrakaran, Vilas; Dienno, Dustin; Csencits, Matthew; Pritts, Michael; Jones, Bryan; McMahan, William; Dawson, Darren; Rahn, Chris; Walker, Ian

    2006-05-01

    This paper describes the development of the octopus biology inspired OctArm series of soft robot manipulators. Each OctArm is constructed using air muscle extensors with three control channels per section that provide two axis bending and extension. Within each section, mesh and plastic coupler constraints prevent extensor buckling. OctArm IV is comprised of four sections connected by endplates, providing twelve degrees of freedom. Performance of OctArm IV is characterized in a lab environment. Using only 4.13 bar of air pressure, the dexterous distal section provides 66% extension and 380° of rotation in less than .5 seconds. OctArm V has three sections and, using 8.27 bar of air pressure, the strong proximal section provides 890 N and 250 N of vertical and transverse load capacity, respectively. In addition to the in-lab testing, OctArm V underwent a series of field trials including open-air and in-water field tests. Outcomes of the trials, in which the manipulator demonstrated the ability for adaptive and novel manipulation in challenging environments, are described. OctArm VI is designed and constructed based on the in-lab performance, and the field testing of its predecessors. Implications for the deployment of soft robots in military environments are discussed.

  11. Robotic Arm Biobarrier Cable

    Science.gov (United States)

    2008-01-01

    This image, taken by the Surface Stereo Imager on NASA's Phoenix Mars Lander on the 14th Martian day of the mission (June 7, 2008), shows the cable that held the Robotic Arm's biobarrier in place during flight has snapped. The cable's springs retracted to release the biobarrier right after landing. To the lower right of the image a spring is visible. Extending from that spring is a length of cable that snapped during the biobarrier's release. A second spring separated from the cable when it snapped and has been photographed on the ground under the lander near one of the legs. 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.

  12. 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...

  13. 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 ...

  14. Intervention trial of previous nonattender invitation for breast screening.

    Science.gov (United States)

    Fleming, Padraic; Mooney, Therese; Wilson, Linda; Fitzpatrick, Patricia

    2016-11-01

    BreastCheck, the National Breast Screening Programme in the Republic of Ireland, invites women aged between 50 and 64 years biennially. A pilot intervention trial of invitation for screening of women not attending the previous appointment [previous nonattender (PNA)] was carried out that aimed at maximizing the efficiency of resources in terms of radiographer workload and scheduled appointment slots. The trial was conducted during screening round 5 at two of the regional units. The intervention arm implemented an alternative process for inviting PNA women, in which they were sent a letter inviting them to phone their screening unit to make an appointment at a convenient date/time. The control arm continued usual practice - that is, all PNA women were sent a single invitation letter with a scheduled appointment slot at a predetermined date/time. In the intervention arm, fewer PNAs took up their appointments (15.5%) compared with the control arm (18.3%; P<0.001). Uptake among PNAs fell in both arms between screening rounds 4 and 5 (intervention arm: 22.0% OSR 4, 15.5% OSR 5; control arm: 21.4% OSR 4, 18.3% OSR 5). There was a significant increase in mobile unit screening days saved because of the intervention and a significant improvement in the percentage of women reinvited for screening within 27 months in the intervention arm (85.5%). PNA recall and cancer detection rates were significantly higher compared with the general screened population. This trial showed an improvement in the efficiency of resource use. However, there was a higher cancer detection rate in PNA women. This trial provides important evidence for invitation policy for screening. PMID:26642321

  15. 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.

  16. 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.

  17. Arménie

    Directory of Open Access Journals (Sweden)

    François Verdier

    2012-04-01

    Full Text Available L’Arménie est une petite république du Caucase, à la limite sud–est de l’Europe, qui a gagné son autonomie en 1990 après l’ouverture du bloc soviétique. Le nouveau Ministère du Patrimoine a sollicité la coopération de la France pour mettre en place une nouvelle politique culturelle. Tout d’abord, une évaluation sur place de la situation dans les domaines des monuments historiques, de l’archéologie et de l’Inventaire a permis d’envisager les réponses à proposer. Pour la demande d’informatisation des dossiers d’inventaire déjà réalisés sous l’autorité de l’Académie de Saint–Petersbourg, nous avons proposé de former des chercheurs arméniens aux méthodes et techniques de l’Inventaire général. L’accueil d’une stagiaire pendant trois mois au service régional de l’Inventaire de Haute–Normandie a été suivi par la mise en place d’un équipement informatique à Yérévan, puis par l’accueil et la formation de techniciens informaticiens et photographes arméniens. De retour dans leur pays ils ont commencé à remettre en place un service d’inventaire dont le programme comprend la création d’une base de données patrimoniales, le recensement de la ville de Yérévan, la numérisation d’images pour la publication d’un indicateur du patrimoine et la préparation de dossiers de protection au titre du patrimoine mondial.The Armenian heritage comprises both archaeological remains of towns destroyed by never–ending wars and a number of old churches from the eleventh and twelfth centuries. Yerevan, the capital of Armenia, was founded three thousand years ago and is one of Europe’s oldest capitals. From 1925 it has developed according to an ambitious urban planning project. After the major political upheavals of 1991, a special ministry was created to look after the architectural and movable heritage of the country and to promote the Armenian national identity. A mission in Yerevan was

  18. 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.

  19. 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

  20. 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.

  1. 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.

  2. [Apothecaries' arms of Voltaire's family].

    Science.gov (United States)

    Chaigneau, M

    1998-01-01

    Apothecaries of Voltaire's family can be divided into two groups. Marceton Family: Claude Marceton, Hierosme and Pierre Testefolle, from Thouars. Arouet family: Jehan Arouet, Pierre Rochard and Jean Gougeard. Five of those apothecaries beand arms. PMID:11625327

  3. Bistable Head Positioning Arm Latch

    Science.gov (United States)

    Wasson, Ken; Endo, Juro; Mita, Masahiro; Abelein, Nathan

    A simple, low cost, yet effective device has been developed for immobilizing the head-arm assembly in a disk drive or similar mechanism during power-off conditions. The latching scheme also provides a consistent means of releasing the head-arm assembly from the immobilized position upon power up of the disk drive. The latch uses no electrical power in either immobilized or released state. This design is immune to extreme torque and linear shock forces applied to the disk drive case. The latch system can use the energy stored in the spinning disks to drive the head-arm assembly toward a safe position while simultaneously arming the latch mechanism to secure the head-arm assembly in the safe position upon arrival. A low energy five msec pulse of current drives the latch from one state to the other. Solenoids as presently used in latch mechanisms are bulky, expensive, have variable force characteristics, and often generate contaminants. The latch described in this paper is expected to replace such solenoids. It may also replace small magnet latches, which have limited latch force and apply unwanted torque to a proximate head positioning arm.

  4. Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Dabholkar Hamid

    2011-01-01

    Full Text Available Abstract Background There is a large treatment gap with few community services for people with schizophrenia in low income countries largely due to the shortage of specialist mental healthcare human resources. Community based rehabilitation (CBR, involving lay health workers, has been shown to be feasible, acceptable and more effective than routine care for people with schizophrenia in observational studies. The aim of this study is to evaluate whether a lay health worker led, Collaborative Community Based Care (CCBC intervention, combined with usual Facility Based Care (FBC, is superior to FBC alone in improving outcomes for people with schizophrenia and their caregivers in India. Methods/Design This trial is a multi-site, parallel group randomised controlled trial design in India. The trial will be conducted concurrently at three sites in India where persons with schizophrenia will be screened for eligibility and recruited after providing informed consent. Trial participants will be randomly allocated in a 2:1 ratio to the CCBC+FBC and FBC arms respectively using an allocation sequence pre-prepared through the use of permuted blocks, stratified within site. The structured CCBC intervention will be delivered by trained lay community health workers (CHWs working together with the treating Psychiatrist. We aim to recruit 282 persons with schizophrenia. The primary outcomes are reduction in severity of symptoms of schizophrenia and disability at 12 months. The study will be conducted according to good ethical practice, data analysis and reporting guidelines. Discussion If the additional CCBC intervention delivered by front line CHWs is demonstrated to be effective and cost-effective in comparison to usually available care, this intervention can be scaled up to expand coverage and improve outcomes for persons with schizophrenia and their caregivers in low income countries. Trial registration The trial is registered with the International Society

  5. 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, ...

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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 ...

  11. Participating in Clinical Trials

    Science.gov (United States)

    ... 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 ...

  12. 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.

  13. 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

  14. 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...

  15. 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.

  16. 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.

  17. 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

  18. 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

  19. Ranking the European armed forces

    NARCIS (Netherlands)

    Beeres, R.J.M.; Bogers, M.

    2012-01-01

    The degree of collectiveness aimed for in European defence policy raises issues such as burden sharing and relative performance measurement of the European Armed Forces (EAF). This paper compares EAF performance rates on three dimensions: input, throughput and output. In order to express performance

  20. 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).

  1. 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…

  2. 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

  3. Multiple Identifications in Multi-Armed Bandits

    CERN Document Server

    Bubeck, Sébastien; Viswanathan, Nitin

    2012-01-01

    We study the problem of identifying the top $m$ arms in a multi-armed bandit game. Our proposed solution relies on a new algorithm based on successive rejects of the seemingly bad arms, and successive accepts of the good ones. This algorithmic contribution allows to tackle other multiple identifications settings that were previously out of reach. In particular we show that this idea of successive accepts and rejects applies to the multi-bandit best arm identification problem.

  4. 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.

  5. 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 ...

  6. 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.

  7. 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

  8. 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 ( ...

  9. Regenerator cross arm seal assembly

    Science.gov (United States)

    Jackman, Anthony V.

    1988-01-01

    A seal assembly for disposition between a cross arm on a gas turbine engine block and a regenerator disc, the seal assembly including a platform coextensive with the cross arm, a seal and wear layer sealingly and slidingly engaging the regenerator disc, a porous and compliant support layer between the platform and the seal and wear layer porous enough to permit flow of cooling air therethrough and compliant to accommodate relative thermal growth and distortion, a dike between the seal and wear layer and the platform for preventing cross flow through the support layer between engine exhaust and pressurized air passages, and air diversion passages for directing unregenerated pressurized air through the support layer to cool the seal and wear layer and then back into the flow of regenerated pressurized air.

  10. 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 ...

  11. 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 ...

  12. 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 ...

  13. 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 ...

  14. 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 ...

  15. 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

  16. 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.

  17. 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

  18. 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…

  19. Photovoltaic Devices from Multi-Armed CdS Nanorods and Conjugated Polyme, Composites

    Institute of Scientific and Technical Information of China (English)

    LIU Yan-Shan; WANG Li; QIN Dong-Huan; CAO Yong

    2006-01-01

    We demonstrate the preparation of composite photovoltaic devices by using the blends of multi-armed CdS nanorods with conjugated polymer, poly[2-methoxy-5-(2'-ethylhexyloxy)-l,4-phenylenevinylene] (MEH-PPV). Multi-armed CdS nanorods are prepared by thermolysing single precursor cadmium ethylxanthate [Cd(exan)2] in pure hexadecylamine solution under ambient conditions. The photoluminescence of MEH-PPV can be ef fectively quenched in the composites at high CdS nanocrystal (nc-CdS)/MEH-PPV ratios. Post-treatment of the multi-armed CdS nanorods by refluxing in pyridine significantly increases the performance of the composite photovoltaic devices. Power conversion efficiency is obtained to be 0.17% under AM 1.5 illumination for this composite device.

  20. 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

  1. 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…

  2. 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.

  3. 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.

  4. [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

  5. 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.

  6. Narrative Arts in A Farewell to Arms

    Institute of Scientific and Technical Information of China (English)

    周鋆

    2015-01-01

    Most of Hemingway's contributions to literature lie in his artistic version,as well as his art of narration.This paper means to give an analysis of A Farewell to Arms from its art of narration.Drawing from theories of narratology,the dissertation focuses on the analysis of narrative time,narrative person and narrative voice as they are presented in A Farewell to Arms.The aim of this dissertation is to make an objective analysis of Hemingway's narrative power in A Farewell to Arms from narrative perspectives,and tries to find out why A Farewell to Arms are enduring and great.

  7. Immediate Effects of Smoking on Cardiorespiratory Responses During Dynamic Exercise: Arm Versus Leg Ergometry

    Directory of Open Access Journals (Sweden)

    Chien-Liang eChen

    2015-12-01

    Full Text Available Purpose: This study compared the immediate effects of smoking on cardiorespiratory responses to dynamic arm and leg exercises. Methods: This randomized crossover study recruited 14 college students. Each participant underwent 2 sets of arm-cranking (AC and leg-cycling (LC exercise tests. The testing sequences of the control trial (participants refrained from smoking for 8 hours before testing and the experimental trial (participants smoked 2 cigarettes were randomly chosen. We observed immediate changes in pulmonary function and heart rate variability after smoking and before the exercise test. The participants then underwent graded exercise tests of their arms and legs, respectively, until reaching exhaustion. We compared the peak work achieved and the time to exhaustion during the exercise tests with various cardiorespiratory indices [i.e., heart rate, oxygen consumption (VO2, minute ventilation (VE]. The main effects of the time and the trial, as well as their interaction effects on outcome measures, were investigated using repeated measure ANOVA.Results: Five minutes after smoking, the participants exhibited reduced forced vital capacities and forced expiratory volumes in the first second (P < .05, in addition to elevated resting heart rates (P < .001. The high-frequency, low-frequency, and the total power of the heart rate variability were also reduced (P < .05 at rest. For the exercise test periods, smoking reduced the time to exhaustion (P = .005 and the ventilatory threshold (P < .05 in the LC tests, whereas there were no significant effects in the AC tests. A trend analysis revealed a significant (P < .001 trial-by-time interaction effect for heart rate, VO2, and VE during the graded exercise test. Lower VO2 and VE levels were exhibited in the exercise response of the smoking trial than in that of the control LC trials, whereas there was no discernable inter-trial difference in the AC trials. Moreover, the differences in heart rate

  8. 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.

  9. 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

  10. 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...

  11. 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

  12. 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...

  13. 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.

    Science.gov (United States)

    White, David J; Cox, Katherine H M; Peters, Riccarda; Pipingas, Andrew; Scholey, Andrew B

    2015-11-01

    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 supplementation may have beneficial effects on mood, underpinned by elevated B-vitamins and lowered homocysteine in healthy young adults. PMID:26529011

  14. 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.

    Science.gov (United States)

    White, David J; Cox, Katherine H M; Peters, Riccarda; Pipingas, Andrew; Scholey, Andrew B

    2015-10-30

    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 vitamins and lowered homocysteine in healthy young adults.

  15. 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

  16. HPTN 071 (PopART: a cluster-randomized trial of the population impact of an HIV combination prevention intervention including universal testing and treatment: mathematical model.

    Directory of Open Access Journals (Sweden)

    Anne Cori

    Full Text Available BACKGROUND: The HPTN 052 trial confirmed that antiretroviral therapy (ART can nearly eliminate HIV transmission from successfully treated HIV-infected individuals within couples. Here, we present the mathematical modeling used to inform the design and monitoring of a new trial aiming to test whether widespread provision of ART is feasible and can substantially reduce population-level HIV incidence. METHODS AND FINDINGS: The HPTN 071 (PopART trial is a three-arm cluster-randomized trial of 21 large population clusters in Zambia and South Africa, starting in 2013. A combination prevention package including home-based voluntary testing and counseling, and ART for HIV positive individuals, will be delivered in arms A and B, with ART offered universally in arm A and according to national guidelines in arm B. Arm C will be the control arm. The primary endpoint is the cumulative three-year HIV incidence. We developed a mathematical model of heterosexual HIV transmission, informed by recent data on HIV-1 natural history. We focused on realistically modeling the intervention package. Parameters were calibrated to data previously collected in these communities and national surveillance data. We predict that, if targets are reached, HIV incidence over three years will drop by >60% in arm A and >25% in arm B, relative to arm C. The considerable uncertainty in the predicted reduction in incidence justifies the need for a trial. The main drivers of this uncertainty are possible community-level behavioral changes associated with the intervention, uptake of testing and treatment, as well as ART retention and adherence. CONCLUSIONS: The HPTN 071 (PopART trial intervention could reduce HIV population-level incidence by >60% over three years. This intervention could serve as a paradigm for national or supra-national implementation. Our analysis highlights the role mathematical modeling can play in trial development and monitoring, and more widely in evaluating the

  17. 'Pico-Bello-Klean study': effectiveness and patient tolerability of bowel preparation agents sodium picosulphate-magnesium citrate and polyethylene glycol before colonoscopy. A single-blinded randomized trial

    NARCIS (Netherlands)

    Munsterman, I.D.; Cleeren, E.; Ploeg, T. van der; Brohet, R.; Hulst, R van der

    2015-01-01

    OBJECTIVES: Adequate bowel preparation is an important step for an effective colonoscopy. Polyethylene glycol solution (Kleanprep) and sodium picosulphate with a magnesium citrate solution (Picoprep) are bowel cleansing agents registered and available for this purpose. So far, the results of studies

  18. 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...

  19. Rock Moved by Mars Lander Arm, Stereo View

    Science.gov (United States)

    2008-01-01

    The robotic arm on NASA's Phoenix Mars Lander slid a rock out of the way during the mission's 117th Martian day (Sept. 22, 2008) to gain access to soil that had been underneath the rock.The lander's Surface Stereo Imager took the two images for this stereo view later the same day, showing the rock, called 'Headless,' after the arm pushed it about 40 centimeters (16 inches) from its previous location. 'The rock ended up exactly where we intended it to,' said Matt Robinson of NASA's Jet Propulsion Laboratory, robotic arm flight software lead for the Phoenix team. The arm had enlarged the trench near Headless two days earlier in preparation for sliding the rock into the trench. The trench was dug to about 3 centimeters (1.2 inches) deep. The ground surface between the rock's prior position and the lip of the trench had a slope of about 3 degrees downward toward the trench. Headless is about the size and shape of a VHS videotape. The Phoenix science team sought to move the rock in order to study the soil and the depth to subsurface ice underneath where the rock had been. This left-eye and right-eye images for this stereo view were taken at about 12:30 p.m., local solar time on Mars. The scene appears three-dimensional when seen through blue-red glasses.The view is to the north northeast of the lander. The Phoenix Mission is led by the University of Arizona, Tucson, on behalf of NASA. Project management of the mission is by JPL, Pasadena, Calif. Spacecraft development was by Lockheed Martin Space Systems, Denver.

  20. 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.

  1. Xpert MTB/RIF - why the lack of morbidity and mortality impact in intervention trials?

    Science.gov (United States)

    Auld, Andrew F; Fielding, Katherine L; Gupta-Wright, Ankur; Lawn, Stephen D

    2016-08-01

    Compared with smear microscopy, the Xpert MTB/RIF assay (Xpert), with superior accuracy and capacity to diagnose rifampicin resistance, has advanced TB diagnostic capability. However, recent trials of Xpert impact have not demonstrated reductions in patient morbidity and mortality. We conducted a narrative review of Xpert impact trials to summarize which patient-relevant outcomes Xpert has improved and explore reasons for no observed morbidity or mortality reductions. We searched PubMed, Google Scholar, Cochrane Library and Embase and identified eight trials meeting inclusion criteria: three individually randomized, three cluster-randomized, and two pre-post trials. In six trials Xpert increased diagnostic yield of bacteriologically-confirmed TB from sputa and in four trials Xpert shortened time to TB treatment. However, all-cause mortality was similar between arms in all six trials reporting this outcome, and the only trial to assess Xpert impact on morbidity reported no impact. Trial characteristics that might explain lack of observed impact on morbidity and mortality include: higher rates of empiric TB treatment in microscopy compared with Xpert arms, enrollment of study populations not comprised exclusively of populations most likely to benefit from Xpert, and health system weaknesses. So far as equipoise exists, future trials that address past limitations are needed to inform Xpert use in resource-limited settings. PMID:27638038

  2. Design of a biomimetic robotic octopus arm

    Energy Technology Data Exchange (ETDEWEB)

    Laschi, C; Cianchetti, M [Advanced Robotics Technology and Systems Laboratory, Scuola Superiore Sant' Anna, Pisa (Italy); Mazzolai, B; Dario, P [Italian Institute of Technology, Genova (Italy); Mattoli, V [Centre of Research in Microengineering Laboratory, Scuola Superiore Sant' Anna, Pisa (Italy)], E-mail: cecilia.laschi@sssup.it

    2009-03-01

    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.

  3. Why we cannot grow a human arm.

    Science.gov (United States)

    Ricci, John L

    2013-11-01

    There are several significant issues that prevent us from growing a human arm now, or within the next 10-20 years. From a tissue engineering perspective, while we can grow many of the components necessary for construction of a human arm, we can only grow them in relatively small volumes, and when scaled up to large volumes we lack the ability to develop adequate blood/nerve supply. From a genetic engineering perspective, we will probably never be able to turn on the specific genes necessary to "grow an arm" unless it is attached to a fetus and this presents enormous ethical issues related to farming of human organs and structures. Perhaps the most daunting problem facing the transplantation of a tissue engineered or transplanted arm is that of re-innervation of the structure. Since the sensory and motor nerve cells of the arm are located outside of the structure, re-innervation requires those nerves to regenerate over relatively large distances to repopulate the nervous system of the arm. This is something with which we have had little success. We can grow repair parts, but "growing an arm" presents too many insurmountable problems. The best we could possibly do with tissue engineering or genetic engineering would be the equivalent of a fetal arm and the technical problems, costs, and ethical hurdles are enormous. A more likely solution is a functional, permanent, neuroelectronically-controlled prosthesis. These are nearly a reality today.

  4. 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…

  5. Books in Action: The Armed Services Editions.

    Science.gov (United States)

    Cole, John Y., Ed.

    In an effort to reach a wide audience, the Center for the Book in the Library of Congress presents this book in honor of the 40th anniversary celebration of the Armed Services Editions (ASE), the paperback books distributed during World War II. The titles of the essays and their authors are as follows: "The Armed Services Editions: An…

  6. Gender Integration and the Swedish Armed Forces

    DEFF Research Database (Denmark)

    Gustafsson, Daniel Marcus Sunil

    This paper discusses different gender aspects of the Swedish Armed Forces with specific references to sexual harassment and prostitution. By using the concept of Hegemonic Masculinity, sexual harassment of the women in the Swedish Armed Forces is explained in terms of a need of the men within...

  7. 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

  8. 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.

  9. 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...

  10. Design And Implementation Of Anthropomorphic Robotic Arm

    Directory of Open Access Journals (Sweden)

    Ashish Sharma

    2014-01-01

    Full Text Available The report focuses on the design and demonstration of an anthropomorphic robotic arm with seven degrees of freedom using readily available low-cost components to perform different real time human hand applications. The robotic arm consists of a shoulder, elbow, wrist and a five-finger gripper. It can perform different gripping actions, such as lateral, spherical, cylindrical and tip-holding gripping actions; each finger has three movable links. The actuator used for the robotic arm is a high torque dc servo motor and the five-finger gripper consists of five cables placed like tendons in the human arm. Implementation is done using a human hand glove which senses the motion from sensor technology to produce a proportional analog voltage, digitized via the microcontroller Atmel ATmega32. The microcontroller then through the processed signal controls the mechanical structure that is the robotic arm. Keywords –

  11. 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

    Science.gov (United States)

    White, David J.; Cox, Katherine H. M.; Peters, Riccarda; Pipingas, Andrew; Scholey, Andrew B.

    2015-01-01

    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. PMID:26529011

  12. 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.

  13. 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...

  14. First-line therapy in ovarian cancer trials.

    Science.gov (United States)

    Thigpen, Tate; duBois, Andreas; McAlpine, Jessica; DiSaia, Philip; Fujiwara, Keiichi; Hoskins, William; Kristensen, Gunnar; Mannel, Robert; Markman, Maurie; Pfisterer, Jacobus; Quinn, Michael; Reed, Nick; Swart, Ann Marie; Berek, Jonathan; Colombo, Nicoletta; Freyer, Gilles; Gallardo, Dolores; Plante, Marie; Poveda, Andres; Rubinstein, Lawrence; Bacon, Monica; Kitchener, Henry; Stuart, Gavin C E

    2011-05-01

    At the 4th Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup (GCIG) held in Vancouver, Canada, in June 2010, representatives of 23 cooperative research groups studying gynecologic cancers gathered to establish international consensus on issues critical to the conduct of large randomized trials. The process focused on 13 predetermined questions. Group A, 1 of the 3 discussion groups, addressed the first 5 questions, examining first-line therapies in newly diagnosed ovarian cancer patients. A1: What are the appropriate end points for different trials (maintenance, upfront chemotherapy trials including molecular drugs)? A2: Are there any subgroups defined by tumor biology who need specific treatment options/trials? A3: Is the 2004 GCIG-recommended standard comparator arm still valid? A4: What is the role of modifying dose, schedule, and delivery of chemotherapy? A5: What role does surgery play today?

  15. The transitive fallacy for randomized trials: If A bests B and B bests C in separate trials, is A better than C?

    Directory of Open Access Journals (Sweden)

    Kramer Barnett S

    2002-11-01

    Full Text Available Abstract Background If intervention A bests B in one randomized trial, and B bests C in another randomized trial, can one conclude that A is better than C? The problem was motivated by the planning of a randomized trial, where A is spiral-CT screening, B is x-ray screening, and C is no screening. On its surface, this would appear to be a straightforward application of the transitive principle of logic. Methods We extended the graphical approach for omitted binary variables that was originally developed to illustrate Simpson's paradox, applying it to hypothetical, but plausible scenarios involving lung cancer screening, treatment for gastric cancer, and antibiotic therapy for clinical pneumonia. Results Graphical illustrations of the three examples show different ways the transitive fallacy for randomized trials can arise due to changes in an unobserved or unadjusted binary variable. In the most dramatic scenario, B bests C in the first trial, A bests B in the second trial, but C bests A at the time of the second trial. Conclusion Even with large sample sizes, combining results from a previous randomized trial of B versus C with results from a new randomized trial of A versus B will not guarantee correct inference about A versus C. A three-arm trial of A, B, and C would protect against this problem and should be considered when the sequential trials are performed in the context of changing secular trends in important omitted variables such as therapy in cancer screening trials.

  16. 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.

  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. 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.

  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. 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.

  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.

  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. 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 ...

  4. 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 ...

  5. 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.

  6. 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

  7. 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

    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...... of 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...

  8. 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 ...

  9. Organising trials by themes

    NARCIS (Netherlands)

    Hop, M.E.C.M.

    2013-01-01

    In recent years in the Netherlands the demand for a different type of cultivar trial has increased: the themed trial. Themed trials gather information on one property of a range of garden plants, like their winter hardiness or scent, or research the suitability of a range of plants for a specific us

  10. 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.

  11. 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

  12. 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.

  13. Rapid learning of magnetic compass direction by C57BL/6 mice in a 4-armed 'plus' water maze.

    Directory of Open Access Journals (Sweden)

    John B Phillips

    Full Text Available Magnetoreception has been demonstrated in all five vertebrate classes. In rodents, nest building experiments have shown the use of magnetic cues by two families of molerats, Siberian hamsters and C57BL/6 mice. However, assays widely used to study rodent spatial cognition (e.g. water maze, radial arm maze have failed to provide evidence for the use of magnetic cues. Here we show that C57BL/6 mice can learn the magnetic direction of a submerged platform in a 4-armed (plus water maze. Naïve mice were given two brief training trials. In each trial, a mouse was confined to one arm of the maze with the submerged platform at the outer end in a predetermined alignment relative to magnetic north. Between trials, the training arm and magnetic field were rotated by 180(° so that the mouse had to swim in the same magnetic direction to reach the submerged platform. The directional preference of each mouse was tested once in one of four magnetic field alignments by releasing it at the center of the maze with access to all four arms. Equal numbers of responses were obtained from mice tested in the four symmetrical magnetic field alignments. Findings show that two training trials are sufficient for mice to learn the magnetic direction of the submerged platform in a plus water maze. The success of these experiments may be explained by: (1 absence of alternative directional cues (2, rotation of magnetic field alignment, and (3 electromagnetic shielding to minimize radio frequency interference that has been shown to interfere with magnetic compass orientation of birds. These findings confirm that mice have a well-developed magnetic compass, and give further impetus to the question of whether epigeic rodents (e.g., mice and rats have a photoreceptor-based magnetic compass similar to that found in amphibians and migratory birds.

  14. 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

  15. 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.

  16. 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.

  17. 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...

  18. 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...

  19. 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

  20. 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

  1. 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).

  2. 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

  3. The arms race between fishers

    Science.gov (United States)

    Rijnsdorp, Adriaan D.; Poos, Jan Jaap; Quirijns, Floor J.; HilleRisLambers, Reinier; De Wilde, Jan W.; Den Heijer, Willem M.

    An analysis of the changes in the Dutch demersal fishing fleet since the 1950s revealed that competitive interactions among vessels and gear types within the constraints imposed by biological, economic and fisheries management factors are the dominant processes governing the dynamics of fishing fleets. Double beam trawling, introduced in the early 1960s, proved a successful fishing method to catch deep burying flatfish, in particular sole. In less than 10 years, the otter trawl fleet was replaced by a highly specialised beam trawling fleet, despite an initial doubling of the loss rate of vessels due to stability problems. Engine power, size of the beam trawl, number of tickler chains and fishing speed rapidly increased and fishing activities expanded into previously lightly fished grounds and seasons. Following the ban on flatfish trawling within the 12 nautical mile zone for vessels of more than 300 hp in 1975 and with the restriction of engine power to 2000 hp in 1987, the beam trawl fleet bifurcated. Changes in the fleet capacity were related to the economic results and showed a cyclic pattern with a period of 6-7 years. The arms race between fishers was fuelled by competitive interactions among fishers: while the catchability of the fleet more than doubled in the ten years following the introduction of the beam trawl, a decline in catchability was observed in reference beam trawlers that remained the same. Vessel performance was not only affected by the technological characteristics but also by the number and characteristics of competing vessels.

  4. 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.

  5. 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...

  6. 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

  7. 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.

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

    Science.gov (United States)

    Ding, Hong; Yong, Ken-Tye; Roy, Indrajit; Hu, Rui; Wu, Fang; Zhao, Lingling; Law, Wing-Cheung; Zhao, Weiwei; Ji, Wei; Liu, Liwei; Bergey, Earl J.; Prasad, Paras N.

    2011-04-01

    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.

  9. 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.

  10. [Multicenter trial for sudden hearing loss therapy - planning and concept].

    Science.gov (United States)

    Plontke, S K; Girndt, M; Meisner, C; Probst, R; Oerlecke, I; Richter, M; Steighardt, J; Dreier, G; Weber, A; Baumann, I; Plößl, S; Löhler, J; Laszig, R; Werner, J A; Rahne, T

    2016-04-01

    Systemic steroids are widely used worldwide as a standard of care for primary therapy of idiopathic sudden sensorineural hearing loss (ISSHL). The German ISSHL guideline recommends high-dose steroids for primary therapy of ISSHL, without evidence from randomized controlled trials (RCTs). The rationale for the treatment of ISSHL using high dose steroids is only based on retrospective cohort studies.This article describes the planning and initiation of a multicenter, national, randomized, controlled clinical trial entitled Efficacy and safety of high dose glucocorticosteroid treatment for idiopathic sudden sensorineural hearing loss - a three-armed, randomized, triple-blind, multicenter trial (HODOKORT). This clinical trial aims to compare standard dose with two types of high-dose steroids for primary systemic therapy with respect to their efficacy in improving hearing, and thus communication ability, in patients with idiopathic sudden sensorineural hearing loss.This study is funded by the "Clinical Trials with High Patient Relevance" research program in the health research framework of the German Federal Ministry of Education and Research. It is one of two studies by the German Study Center of Clinical Trials of the German Society of Otorhinolaryngology, Head and Neck Surgery (DSZ-HNO). Planning and initiation was done in cooperation with the DSZ-HNO, the Coordination Center of Clinical Trials of the Martin-Luther-University Halle-Wittenberg, and the Study Center of the University Hospital Freiburg.

  11. Erythropoietin therapy after allogeneic hematopoietic cell transplantation: a prospective, randomized trial.

    Science.gov (United States)

    Jaspers, Aurélie; Baron, Frédéric; Willems, Evelyne; Seidel, Laurence; Hafraoui, Kaoutar; Vanstraelen, Gaetan; Bonnet, Christophe; Beguin, Yves

    2014-07-01

    We conducted a prospective randomized trial to assess hemoglobin (Hb) response to recombinant human erythropoietin (rhEPO) therapy after hematopoietic cell transplantation (HCT). Patients (N = 131) were randomized (1:1) between no treatment (control arm) or erythropoietin at 500 U/kg per week (EPO arm). Patients were also stratified into 3 cohorts: patients undergoing myeloablative HCT with rhEPO to start on day (D)28, patients given nonmyeloablative HCT (NMHCT) with rhEPO to start on D28, and patients also given NMHCT but with rhEPO to start on D0. The proportion of complete correctors (ie, Hb ≥13 g/dL) before D126 posttransplant was 8.1% in the control arm (median not reached) and 63.1% in the EPO arm (median, 90 days) (P < .001). Hb levels were higher and transfusion requirements decreased (P < .001) in the EPO arm, but not during the first month in the nonmyeloablative cohort starting rhEPO on D0. There was no difference in rates of thromboembolic events or other complications between the 2 arms. This is the first randomized trial to demonstrate that rhEPO therapy hastens erythroid recovery and decreases transfusion requirements when started one month after allogeneic HCT. There was no benefit to start rhEPO earlier after NMHCT.

  12. 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.

  13. Firm exit and armed conflict in Colombia

    OpenAIRE

    Camacho, Andriana; Rodriguez, Catherine

    2010-01-01

    This paper uses two unique panel data sets to study the causal effect that armed conflict has over entrepreneurial activity in Colombia. Using a fixed effect estimation methodology at the plant level and controlling for the possible endogeneity of armed conflict through the use of instrumental variables, we find that a one standard deviation in the number of guerrilla and paramilitary attacks in a municipality increases the probability of firm exit in 8.1 percentage points. This effect is str...

  14. 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.

  15. 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...

  16. 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 ...

  17. 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.

    Science.gov (United States)

    2015-09-01

    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 titered 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.

  18. 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

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

    NARCIS (Netherlands)

    Verbakel, N.J.; Langelaan, M.; Verheij, T.J.M.; Wagner, C.; Zwart, D.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 was

  20. 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

  1. Comparability of prostate trials

    DEFF Research Database (Denmark)

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

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...... of antiandrogen (flutamide, Anandron, or cyproterone acetate) added to castration. This paper reviews the different types of heterogeneity that might exist among trials that are involved in the overview: study design, randomization procedure, treatment evaluation, statistical evaluation, and data maturity...

  2. 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.

  3. Difluoromethane preparation

    NARCIS (Netherlands)

    Wiersma, A.; Sandt, E.J.A.; Van Bekkum, H.; Makkee, M.; Moulijn, J.A.

    1996-01-01

    Abstract of NL 9401574 (A) The invention relates to a method for preparing difluoromethane, wherein dichlorodifluoromethane or monochlorodifluoromethane is brought into contact with hydrogen in the presence of palladium on activated carbon, wherein the loading of the palladium on the activated c

  4. 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

  5. A novel elevated plus-maze procedure to avoid the one-trial tolerance problem

    Directory of Open Access Journals (Sweden)

    Peggy eSchneider

    2011-07-01

    Full Text Available The elevated plus-maze (EPM test is one of the most commonly used behavioural assays to evaluate anxiety-related behaviour in rodents. It is a rather economic test which usually uses a short (5 min protocol and does not require conditioning of the animals. The critical measure for anxiety is the time spent in the open arms of the maze. A confounding problem of the EPM is the so called one-trial tolerance (OTT, characterised by a marked decrease of open arm exploration in spite of treatment with anxiolytic acting benzodiazepines upon re-exposure to the EPM. This consistent finding is often raised as an evidence for the inappropriateness to re-test rodents in the EPM. However, a reliable re-test paradigm would broaden the usability and effectiveness of this test.Therefore, we tested how a prolongation of the inter-trial interval to 28 days (instead of the usual 24 hours, and an additional change of the testing room would affect the open arm time and other behaviours on the EPM. In two experiments, drug naive Wistar rats were exposed to the EPM on trial 1, and treated intraperitoneally with either vehicle or midazolam (0.25 mg/kg 30 min before trial 2. Then, trial 2 (28 days after trial 1 was carried out in either the same testing room (Exp. 1 or a second unfamiliar room (Exp. 2.Twenty-eight days after trial 1 the open arm time of the rats in the vehicle treated control rats of both experimental groups was comparable to that of the first trial, independent of the testing room. Most importantly, we found that the treatment with the benzodiazepine midazolam had a significantly anxiolytic-like (i.e. increase of open arm time effect in trial 2 only when conducted in the previously unfamiliar testing room (Exp. 2. We suggest that in order to reliably re-test the EPM and to prevent confounding effects due to the OTT, an inter-trial interval of 28 days and a change in testing rooms reinstates anxiolytic-like actions of benzodiazepines

  6. Crisis in Haiti: Two Hundred Years after Slaves Rose up against France, Armed Rebels Oust Haiti's Elected Leader

    Science.gov (United States)

    Social Education, 2004

    2004-01-01

    Haitians had expected 2004 to be a year of celebrations marking the 200th anniversary of independence from France following the only successful slave revolt of its time. Instead political violence exploded early in the year and armed gunmen took over cities demanding President Jean-Bertrand Aristide resign. Just as the rebels prepared to move in…

  7. 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

  8. 68 Ga-DOTA-TATE的制备及在神经内分泌肿瘤显像中的应用%Preparation of 68 Ga-DOTA-TATE and its clinical trial in neuroendocrine tumor

    Institute of Scientific and Technical Information of China (English)

    朱华; 于江媛; 李囡; 王风; 刘菲; 杨志

    2015-01-01

    Objective To develop an efficient and rapid method to synthesize 68 Ga⁃DOTA⁃TATE, and to perform PET/CT imaging on neuroendocrine tumor (NET) bearing mice and one patient. Methods 68GaCl3 was eluted by 0.05 mol/L HCl in 68 Ge⁃68 Ga generator, then added to pre⁃adjusted DOTA⁃TATE buffer, and heated for 15 min at 85 ℃, then filtered with 0.22 μm microfiltration membrane. The radiochemical purity and in vitro stability of 68 Ga⁃DOTA⁃TATE were analyzed with radio⁃HPLC. The biodistribution and PET/CT imaging on HT⁃29 colon cancer xenografts mice model were performed. After approved by Peking University Cancer Hospital Ethics Committee, a case of NET patient received 148 MBq 68 Ga⁃DOTA⁃TATE intravenous⁃ly, followed by a whole⁃body scan at 60 min post⁃injection. Results 68 Ga⁃DOTA⁃TATE was prepared in high radiochemical purity (>98%) and with specific activity of 55 GBq/μmol in 25 min. The tracer showed excellent in vitro stability and no acute toxicity. PET/CT imaging on mice model showed positive uptake in tumor tissues. PET/CT imaging on one NET patient showed positive uptake of 68 Ga⁃DOTA⁃TATE in primary and metastases lesions. Conclusions A rapid, high radiolabeling yield and high specific activity method to prepare 68 Ga⁃DOTA⁃TATE is established. 68 Ga⁃DOTA⁃TATE could be specifically uptaken by somatostatin receptor ( SSTR) positive NET with high affinity. It could serve as a useful tool for early diagnosis of SSTR positive NET and has clinical prospective for somatostatin⁃mediated targeting therapy.%目的:建立68 Ga⁃DOTA⁃TATE的快速标记方法,并对荷瘤鼠及神经内分泌肿瘤( NET)患者行PET/CT显像。方法用0.05 mol/L HCl从锗⁃镓发生器中直接淋洗出68GaCl3,加入预制的DOTA⁃TATE试剂盒,于85℃条件下保温15 min,经0.22μm微孔滤膜过滤,制得68 Ga⁃DOTA⁃TATE。采用放射性HPLC等方法分析68 Ga⁃DOTA⁃TATE的标记率及体内外稳

  9. 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.

  10. Spiral arms as cosmic ray source distributions

    Science.gov (United States)

    Werner, M.; Kissmann, R.; Strong, A. W.; Reimer, O.

    2015-04-01

    The Milky Way is a spiral galaxy with (or without) a bar-like central structure. There is evidence that the distribution of suspected cosmic ray sources, such as supernova remnants, 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 investigate and measure how the propagation of Galactic cosmic rays is affected by a cosmic ray source distribution associated with spiral arm structures. 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 finding have been obtained for low energy protons and electrons albeit at smaller magnitude. We find that even fractional contributions of a spiral arm component to the total cosmic ray source distribution influences the spectra on the Earth. This is apparent when compared to an axisymmetric radial source distribution as well as with respect to the Earth's position relative to the spiral arm structure. We demonstrate that the presence of a Galactic bar manifests itself as an overall excess of low energy electrons at the Earth. Using a spiral arm geometry as a cosmic ray source distributions offers a genuine new quality of modeling and is used to explain features in cosmic ray spectra at the Earth

  11. 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...

  12. 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

  13. 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 ...

  14. 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 ...

  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. 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 ...

  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. 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...

  19. MIDAS: a practical Bayesian design for platform trials with molecularly targeted agents.

    Science.gov (United States)

    Yuan, Ying; Guo, Beibei; Munsell, Mark; Lu, Karen; Jazaeri, Amir

    2016-09-30

    Recent success of immunotherapy and other targeted therapies in cancer treatment has led to an unprecedented surge in the number of novel therapeutic agents that need to be evaluated in clinical trials. Traditional phase II clinical trial designs were developed for evaluating one candidate treatment at a time and thus not efficient for this task. We propose a Bayesian phase II platform design, the multi-candidate iterative design with adaptive selection (MIDAS), which allows investigators to continuously screen a large number of candidate agents in an efficient and seamless fashion. MIDAS consists of one control arm, which contains a standard therapy as the control, and several experimental arms, which contain the experimental agents. Patients are adaptively randomized to the control and experimental agents based on their estimated efficacy. During the trial, we adaptively drop inefficacious or overly toxic agents and 'graduate' the promising agents from the trial to the next stage of development. Whenever an experimental agent graduates or is dropped, the corresponding arm opens immediately for testing the next available new agent. Simulation studies show that MIDAS substantially outperforms the conventional approach. The proposed design yields a significantly higher probability for identifying the promising agents and dropping the futile agents. In addition, MIDAS requires only one master protocol, which streamlines trial conduct and substantially decreases the overhead burden. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27112322

  20. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  1. 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.

  2. 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.

  3. 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.

  4. 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...

  5. 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.

  6. Characterizing Spiral Arm and Interarm Star Formation

    Science.gov (United States)

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

    2016-08-01

    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 construct Hα maps including detailed corrections for dust extinction and stellar absorption to identify 391 H ii regions at 35 pc resolution over 12 kpc2. Using tracers sensitive to the underlying gravitational potential, we associate H ii regions with either arm (271) or interarm (120) environments. Using our full spectral coverage of each region, we find that most physical properties (luminosity, size, metallicity, ionization parameter) of H ii regions are independent of environment. We calculate the fraction of Hα luminosity due to the background of diffuse ionized gas (DIG) contaminating each H ii region, and find the DIG surface brightness to be higher within H ii regions than in the surroundings, and slightly higher within arm H ii regions. Use of the temperature-sensitive [S ii]/Hα line ratio instead of the Hα surface brightness to identify the boundaries of H ii regions does not change this result. Using the dust attenuation as a tracer of the gas, we find depletion times consistent with previous work (2 × 109 yr) with no differences between the arm and interarm, but this is very sensitive to the DIG correction. Unlike molecular clouds, which can be dynamically affected by the galactic environment, we see fairly consistent properties of H ii regions in both arm and interarm environments. This suggests either a difference in star formation and feedback in arms or a decoupling of dense star-forming clumps from the more extended surrounding molecular gas.

  7. 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...

  8. 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.

  9. Two-Armed, Mobile, Sensate Research Robot

    Science.gov (United States)

    Engelberger, J. F.; Roberts, W. Nelson; Ryan, David J.; Silverthorne, Andrew

    2004-01-01

    The Anthropomorphic Robotic Testbed (ART) is an experimental prototype of a partly anthropomorphic, humanoid-size, mobile robot. The basic ART design concept provides for a combination of two-armed coordination, tactility, stereoscopic vision, mobility with navigation and avoidance of obstacles, and natural-language communication, so that the ART could emulate humans in many activities. The ART could be developed into a variety of highly capable robotic assistants for general or specific applications. There is especially great potential for the development of ART-based robots as substitutes for live-in health-care aides for home-bound persons who are aged, infirm, or physically handicapped; these robots could greatly reduce the cost of home health care and extend the term of independent living. The ART is a fully autonomous and untethered system. It includes a mobile base on which is mounted an extensible torso topped by a head, shoulders, and two arms. All subsystems of the ART are powered by a rechargeable, removable battery pack. The mobile base is a differentially- driven, nonholonomic vehicle capable of a speed >1 m/s and can handle a payload >100 kg. The base can be controlled manually, in forward/backward and/or simultaneous rotational motion, by use of a joystick. Alternatively, the motion of the base can be controlled autonomously by an onboard navigational computer. By retraction or extension of the torso, the head height of the ART can be adjusted from 5 ft (1.5 m) to 6 1/2 ft (2 m), so that the arms can reach either the floor or high shelves, or some ceilings. The arms are symmetrical. Each arm (including the wrist) has a total of six rotary axes like those of the human shoulder, elbow, and wrist joints. The arms are actuated by electric motors in combination with brakes and gas-spring assists on the shoulder and elbow joints. The arms are operated under closed-loop digital control. A receptacle for an end effector is mounted on the tip of the wrist and

  10. 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...

  11. 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.

  12. The quest for the bionic arm.

    Science.gov (United States)

    Hutchinson, Douglas T

    2014-06-01

    The current state of research of upper extremity prosthetic devices is focused on creating a complete prosthesis with full motor and sensory function that will provide amputees with a near-normal human arm. Although advances are being made rapidly, many hurdles remain to be overcome before a functional, so-called bionic arm is a reality. Acquiring signals via nerve or muscle inputs will require either a reliable wireless device or direct wiring through an osseous-integrated implant. The best way to tap into the "knowledge" present in the peripheral nerve is yet to be determined.

  13. Use it and improve it or lose it: interactions between arm function and use in humans post-stroke.

    Directory of Open Access Journals (Sweden)

    Yukikazu Hidaka

    2012-02-01

    Full Text Available "Use it and improve it, or lose it" is one of the axioms of motor therapy after stroke. There is, however, little understanding of the interactions between arm function and use in humans post-stroke. Here, we explored putative non-linear interactions between upper extremity function and use by developing a first-order dynamical model of stroke recovery with longitudinal data from participants receiving constraint induced movement therapy (CIMT in the EXCITE clinical trial. Using a Bayesian regression framework, we systematically compared this model with competitive models that included, or not, interactions between function and use. Model comparisons showed that the model with the predicted interactions between arm function and use was the best fitting model. Furthermore, by comparing the model parameters before and after CIMT intervention in participants receiving the intervention one year after randomization, we found that therapy increased the parameter that controls the effect of arm function on arm use. Increase in this parameter, which can be thought of as the confidence to use the arm for a given level of function, lead to increase in spontaneous use after therapy compared to before therapy.

  14. A Phase 2 Randomized Trial of a Rifapentine plus Moxifloxacin-Based Regimen for Treatment of Pulmonary Tuberculosis

    Science.gov (United States)

    Conde, Marcus B.; Mello, Fernanda C. Q.; Duarte, Rafael Silva; Cavalcante, Solange C.; Rolla, Valeria; Dalcolmo, Margareth; Loredo, Carla; Durovni, Betina; Armstrong, Derek T.; Efron, Anne; Barnes, Grace L.; Marzinke, Mark A.; Savic, Radojka M.; Dooley, Kelly E.; Cohn, Silvia; Moulton, Lawrence H.; Chaisson, Richard E.; Dorman, Susan E.

    2016-01-01

    Background 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. Methods 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. Results 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

  15. 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 ...

  16. The effect of hormone therapy on women's quality of life in the first year of the Estonian Postmenopausal Hormone Therapy trial

    Directory of Open Access Journals (Sweden)

    Veerus Piret

    2012-04-01

    Full Text Available Abstract Background For postmenopausal women, the main reason to start hormone therapy (HT is to reduce menopausal symptoms and to improve quality of life (QOL. The aim of this study was to analyse the impact of HT on different aspects of symptom experience and QOL during a randomised trial. A total of 1823 postmenopausal women were recruited into the Estonian Postmenopausal Hormone Therapy (EPHT trial in 1999–2001. Women were randomised to blind HT, open-label HT, placebo or non-treatment arm. After one year in the trial, a questionnaire was mailed and 1359 women (75% responded, 686 in the HT arms and 673 in the non-HT arms. Mean age at filling in the questionnaire was 59.8 years. The questionnaire included Women's Health Questionnaire (WHQ to assess menopause specific QOL of middle-aged women together with a 17-item questionnaire on symptoms related to menopause, a question about painful intercourse, and a question about women's self-rated health. Results After one year in the trial, fewer women in the HT arms reported hot flashes, trouble sleeping, and sweating on the symptom questionnaire. According to WHQ, women in the HT arms had fewer vasomotor symptoms, sleep problems, and problems with sexual behaviour, but more menstrual symptoms; HT had no effect on depression, somatic symptoms, memory, attractiveness, or anxiety. A smaller proportion of women reported painful intercourse in the HT arms. There were no significant differences between the trial arms in women’s self-rated subjective health. Conclusions The results from the EPHT trial confirm that HT is not justified for treating symptoms, other than vasomotor symptoms, among postmenopausal women. WHQ proved to be a useful and sensitive tool to assess QOL in this age group of women.

  17. 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 cavity preparation are being demonstrated on mammoth ivory. This study indicates that freehand preparation employing an USPL system is possible but challenging, and accompanied by a variety of side-effects. The ablation rate with fixed handpiece is about 10 mm3/min. Factors like defocussing and blinding affect treatment efficiency. Laser sources with higher average output powers might be needed in order to reach sufficient preparation speeds.

  18. Comparability of prostate trials

    DEFF Research Database (Denmark)

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

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...... of antiandrogen (flutamide, Anandron, or cyproterone acetate) added to castration. This paper reviews the different types of heterogeneity that might exist among trials that are involved in the overview: study design, randomization procedure, treatment evaluation, statistical evaluation, and data maturity...... with a larger number of patients and a longer follow-up will contribute more to the overview's results....

  19. 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

  20. [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

  1. Does computer use affect the incidence of distal arm pain?

    DEFF Research Database (Denmark)

    Mikkelsen, Sigurd; Lassen, Christina Funch; Vilstrup, Imogen;

    2012-01-01

    To study how objectively recorded mouse and keyboard activity affects distal arm pain among computer workers.......To study how objectively recorded mouse and keyboard activity affects distal arm pain among computer workers....

  2. 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

  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. 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.

  5. 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

  6. 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.

  7. Light duty utility arm startup plan

    Energy Technology Data Exchange (ETDEWEB)

    Barnes, G.A.

    1998-09-01

    This plan details the methods and procedures necessary to ensure a safe transition in the operation of the Light Duty Utility Arm (LDUA) System. The steps identified here outline the work scope and identify responsibilities to complete startup, and turnover of the LDUA to Characterization Project Operations (CPO).

  8. 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.

  9. 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.

  10. 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)

  11. ATLAS software stack on ARM64

    CERN Document Server

    Smith, Joshua Wyatt; The ATLAS collaboration

    2016-01-01

    The ATLAS experiment explores new hardware and software platforms that, in the future, may be more suited to its data intensive workloads. One such alternative hardware platform is the ARM architecture, which is designed to be extremely power efficient and is found in most smartphones and tablets. CERN openlab recently installed a small cluster of ARM 64-bit evaluation prototype servers. Each server is based on a single-socket ARM 64-bit system on a chip, with 32 Cortex-A57 cores. In total, each server has 128 GB RAM connected with four fast memory channels. This paper reports on the port of the ATLAS software stack onto these new prototype ARM64 servers. This included building the "external" packages that the ATLAS software relies on. Patches were needed to introduce this new architecture into the build as well as patches that correct for platform specific code that caused failures on non-x86 architectures. These patches were applied such that porting to further platforms will need no or only very little adj...

  12. 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

  13. 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

  14. 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.

  15. 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.

  16. 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

  17. 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 ...

  18. 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, ...

  19. Anchor Trial Launch

    Science.gov (United States)

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

  20. 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 ...

  1. 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 ...

  2. 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 ...

  3. 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...

  4. ClinicalTrials.gov

    Data.gov (United States)

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

  5. 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 ...

  6. 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.

  7. 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

  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. Predictive validity of the Hand Arm Risk assessment Method (HARM)

    NARCIS (Netherlands)

    Douwes, M.; Boocock, M.; Coenen, P.; Heuvel, S. van den; Bosch, T.

    2014-01-01

    The Hand Arm Risk assessment Method (HARM) is a simplified risk assessment method for determining musculoskeletal symptoms to the arm, neck and/or shoulder posed by hand-arm tasks of the upper body. The purpose of this study was to evaluate the predictive validity of HARM using data collected from a

  10. 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, ...

  11. Nine-year change in statistical design, profile, and success rates of Phase II oncology trials.

    Science.gov (United States)

    Ivanova, Anastasia; Paul, Barry; Marchenko, Olga; Song, Guochen; Patel, Neerali; Moschos, Stergios J

    2016-01-01

    We investigated nine-year trends in statistical design and other features of Phase II oncology clinical trials published in 2005, 2010, and 2014 in five leading oncology journals: Cancer, Clinical Cancer Research, Journal of Clinical Oncology, Annals of Oncology, and Lancet Oncology. The features analyzed included cancer type, multicenter vs. single-institution, statistical design, primary endpoint, number of treatment arms, number of patients per treatment arm, whether or not statistical methods were well described, whether the drug was found effective based on rigorous statistical testing of the null hypothesis, and whether the drug was recommended for future studies.

  12. Anchoring the "floating arm": Use of proprioceptive and mirror visual feedback from one arm to control involuntary displacement of the other arm.

    Science.gov (United States)

    Brun, C; Guerraz, M

    2015-12-01

    Arm movement control takes advantage of multiple inputs, including those originating from the contralateral arm. In the mirror paradigm, it has been suggested that control of the unseen arm, hidden by the mirror, is facilitated by the reflection of the other, moving arm. Although proprioceptive feedback originating from the moving arm, (the image of which is reflected in the mirror), is always coupled with visual feedback in the mirror paradigm, the former has received little attention. We recently showed that the involuntary arm movement following a sustained, isometric contraction, known as the "floating arm" or "Kohnstamm phenomenon", was adjusted to the passive-motorized displacement of the other arm. However, provision of mirror feedback, that is, the reflection in the mirror of the passively moved arm, did not add to this coupling effect. Therefore, the interlimb coupling in the mirror paradigm may to a large extent have a proprioceptive origin rather than a visual origin. The objective of the present study was to decouple mirror feedback and proprioceptive feedback from the reflected, moving arm and evaluate their respective contributions to interlimb coupling in the mirror paradigm. First (in Experiment 1, under eyes-closed conditions), we found that masking the proprioceptive afferents of the passively moved arm (by co-vibrating the antagonistic biceps and triceps muscles) suppressed the interlimb coupling between involuntary displacement of one arm and passive displacement of the other. Next (in Experiment 2), we masked proprioceptive afferents of the passively moved arm and specifically evaluated mirror feedback. We found that interlimb coupling through mirror feedback (though significant) was weaker than interlimb coupling through proprioceptive feedback. Overall, the present results show that in the mirror paradigm, proprioceptive feedback is stronger and more consistent than visual-mirror feedback in terms of the impact on interlimb coupling.

  13. 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

  14. 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.

  15. 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.

  16. 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

  17. 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.

  18. 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

  19. 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

  20. 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...

  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. 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 180...

  3. 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...

  4. 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

  5. Design of a novel 3-DOF hybrid mechanical arm

    Institute of Scientific and Technical Information of China (English)

    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.

  6. 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.

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

    Energy Technology Data Exchange (ETDEWEB)

    Ding Hong; Yong, Ken-Tye; Roy, Indrajit; Hu Rui; Zhao Lingling; Law, Wing-Cheung; Ji Wei; Liu Liwei; Bergey, Earl J; Prasad, Paras N [Department of Chemistry, Institute for Lasers, Photonics and Biophotonics, University at Buffalo, State University of New York, Buffalo, NY 14260 (United States); Wu Fang [Department of Pharmaceutical Sciences, University at Buffalo, State University of New York, Buffalo, NY 14260 (United States); Zhao Weiwei, E-mail: bergeye@buffalo.edu, E-mail: pnprasad@buffalo.edu [Department of Microbiology and Immunology, University at Buffalo, State University of New York, Buffalo, NY 14215 (United States)

    2011-04-22

    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{sup -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 {alpha}{sub v{beta}3} 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.

  8. Suicide after leaving the UK armed forces--a cohort study.

    Directory of Open Access Journals (Sweden)

    Navneet Kapur

    2009-03-01

    Full Text Available BACKGROUND: Few studies have examined suicide risk in individuals once they have left the military. We aimed to investigate the rate, timing, and risk factors for suicide in all those who had left the UK Armed Forces (1996-2005. METHODS AND FINDINGS: We carried out a cohort study of ex-Armed Forces personnel by linking national databases of discharged personnel and suicide deaths (which included deaths receiving either a suicide or undetermined verdict. Comparisons were made with both general and serving populations. During the study period 233,803 individuals left the Armed Forces and 224 died by suicide. Although the overall rate of suicide was not greater than that in the general population, the risk of suicide in men aged 24 y and younger who had left the Armed Forces was approximately two to three times higher than the risk for the same age groups in the general and serving populations (age-specific rate ratios ranging from 170 to 290. The risk of suicide for men aged 30-49 y was lower than that in the general population. The risk was persistent but may have been at its highest in the first 2 y following discharge. The risk of suicide was greatest in males, those who had served in the Army, those with a short length of service, and those of lower rank. The rate of contact with specialist mental health was lowest in the age groups at greatest risk of suicide (14% for those aged under 20 y, 20% for those aged 20-24 y. CONCLUSIONS: Young men who leave the UK Armed Forces were at increased risk of suicide. This may reflect preservice vulnerabilities rather than factors related to service experiences or discharge. Preventive strategies might include practical and psychological preparation for discharge and encouraging appropriate help-seeking behaviour once individuals have left the services.

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. Camera Augmented Mobile C-arm

    Science.gov (United States)

    Wang, Lejing; Weidert, Simon; Traub, Joerg; Heining, Sandro Michael; Riquarts, Christian; Euler, Ekkehard; Navab, Nassir

    The Camera Augmented Mobile C-arm (CamC) system that extends a regular mobile C-arm by a video camera provides an X-ray and video image overlay. Thanks to the mirror construction and one time calibration of the device, the acquired X-ray images are co-registered with the video images without any calibration or registration during the intervention. It is very important to quantify and qualify the system before its introduction into the OR. In this communication, we extended the previously performed overlay accuracy analysis of the CamC system by another clinically important parameter, the applied radiation dose for the patient. Since the mirror of the CamC system will absorb and scatter radiation, we introduce a method for estimating the correct applied dose by using an independent dose measurement device. The results show that the mirror absorbs and scatters 39% of X-ray radiation.

  15. 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.

  16. 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.

  17. Diversity in the Danish Armed Forces

    DEFF Research Database (Denmark)

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

    The Danish Armed Forces face the functional imperative of becoming a smaller, professional expeditionary force and the societal imperative of including women and ethnic minorities. It currently lags behind its NATO partners in gender and ethnic diversity. Lessons to be learned from NATO members...... and realistic goals, systematically developing recruitment, development, and retention policies, and the superiority of an all-volunteer force over conscription in fulfilling this societal imperative....

  18. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

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

    2015-01-01

    The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct......, and reporting of clinical trials for knee OA we initially drafted recommendations through an iterative process. Members of the working group included representatives from industry and academia. After the working group members reviewed a final draft, they scored the appropriateness for recommendations. After...... and index knee, describing interventions, patient-reported and physical performance measures, structural outcome measures, biochemical biomarkers, and reporting recommendations. In summary, the working group identified 25 recommendations that represent the current best practices regarding clinical trials...

  19. The Perseus arm in the anticenter direction

    Science.gov (United States)

    Monguió, M.; Grosbøl, P.; Figueras, F.

    2015-05-01

    The stellar overdensity due to the Perseus arm has been detected in the anticenter direction through individual field stars. For that purpose, a Str&{uml;o}mgren photometric survey covering 16° ^2 was developed with the Wide Field Camera at the Isaac Newton Telescope. This photometry allowed us to compute individual physical parameters for these stars using a new method based on atmospheric models and evolutionary tracks. The analysis of the surface density as a function of distance for intermediate young stars in this survey allowed us to detect an overdensity at 1.6±0.2 kpc from the Sun, that can be associated with the Perseus arm, with a surface density amplitude of ˜14%. The significance of the detection is above 4σ for all the cases. The fit for the radial scale length of the Galactic disk provided values in the range [2.9,3.5] kpc for the population of the B4-A1 stars. We also analyzed the interstellar visual absorption distribution, and its variation as a function of distance is coherent with a dust layer before the Perseus arm location.

  20. Elastic lever arm model for myosin V

    CERN Document Server

    Vilfan, A

    2005-01-01

    We present a mechanochemical model for myosin V, a two-headed processive motor protein. We derive the properties of a dimer from those of an individual head, which we model both with a 4-state cycle (detached, attached with ADP.Pi, attached with ADP and attached without nucleotide) and alternatively with a 5-state cycle (where the power stroke is not tightly coupled to the phosphate release). In each state the lever arm leaves the head at a different, but fixed, angle. The lever arm itself is described as an elastic rod. The chemical cycles of both heads are coordinated exclusively by the mechanical connection between the two lever arms. The model explains head coordination by showing that the lead head only binds to actin after the power stroke in the trail head and that it only undergoes its power stroke after the trail head unbinds from actin. Both models (4- and 5-state) reproduce the observed hand-over-hand motion and fit the measured force-velocity relations. The main difference between the two models c...

  1. 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.

  2. Self-assembled targeted nanoparticles based on transferrin-modified eight-arm-polyethylene glycol–dihydroartemisinin conjugate

    Science.gov (United States)

    Liu, Kefeng; Dai, Lin; Li, Chunxiao; Liu, Jing; Wang, Luying; Lei, Jiandu

    2016-07-01

    Poor delivery of insoluble anticancer drugs has so far precluded their clinical application. In this study, an efficient tumor targeted-nanoparticle delivery system, transferrin-eight-arm-polyethylene glycol–dihydroartemisinin nanoparticles (TF-8arm-PEG-DHA NPs) for the vehiculation of dihydroartemisinin (DHA) was first prepared and evaluated for its targeting efficiency and cytotoxicity in vitro and in vivo to Lewis lung carcinoma (LLC) cells, which overexpress transferrin receptors (TFRs). The synthesized TF-8arm-PEG–DHA NPs had high solubility (~102 fold of free DHA), relatively high drug loading (~10 wt% DHA), long circulating half-life and moderate particle size (~147 nm). The in vitro cytotoxicity and in vivo tumor growth inhibition studies in LLC-tumor bearing mice confirmed the enhanced efficacy of TF-modified 8arm-PEG-DHA NPs compared to free DHA and non-modified 8arm-PEG-DHA NPs. All these results together supported that the formulation developed in this work exhibited great potential as an effective tumor targeting delivery system for insoluble anticancer drugs.

  3. 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

  4. 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

  5. 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.

  6. Trial-by-trial changes in a priori informational value of external cues and subjective expectancies in human auditory attention.

    Directory of Open Access Journals (Sweden)

    Antonio Arjona

    Full Text Available BACKGROUND: Preparatory activity based on a priori probabilities generated in previous trials and subjective expectancies would produce an attentional bias. However, preparation can be correct (valid or incorrect (invalid depending on the actual target stimulus. The alternation effect refers to the subjective expectancy that a target will not be repeated in the same position, causing RTs to increase if the target location is repeated. The present experiment, using the Posner's central cue paradigm, tries to demonstrate that not only the credibility of the cue, but also the expectancy about the next position of the target are changed in a trial by trial basis. Sequences of trials were analyzed. RESULTS: The results indicated an increase in RT benefits when sequences of two and three valid trials occurred. The analysis of errors indicated an increase in anticipatory behavior which grows as the number of valid trials is increased. On the other hand, there was also an RT benefit when a trial was preceded by trials in which the position of the target changed with respect to the current trial (alternation effect. Sequences of two alternations or two repetitions were faster than sequences of trials in which a pattern of repetition or alternation is broken. CONCLUSIONS: Taken together, these results suggest that in Posner's central cue paradigm, and with regard to the anticipatory activity, the credibility of the external cue and of the endogenously anticipated patterns of target location are constantly updated. The results suggest that Bayesian rules are operating in the generation of anticipatory activity as a function of the previous trial's outcome, but also on biases or prior beliefs like the "gambler fallacy".

  7. On the Complexity of Trial and Error

    CERN Document Server

    Bei, Xiaohui; Zhang, Shengyu

    2012-01-01

    Motivated by certain applications from physics, biochemistry, economics, and computer science, in which the objects under investigation are not accessible because of various limitations, we propose a trial-and-error model to examine algorithmic issues in such situations. Given a search problem with a hidden input, we are asked to find a valid solution, to find which we can propose candidate solutions (trials), and use observed violations (errors), to prepare future proposals. In accordance with our motivating applications, we consider the fairly broad class of constraint satisfaction problems, and assume that errors are signaled by a verification oracle in the format of the index of a violated constraint (with the content of the constraint still hidden). Our discoveries are summarized as follows. On one hand, despite the seemingly very little information provided by the verification oracle, efficient algorithms do exist for a number of important problems. For the Nash, Core, Stable Matching, and SAT problems,...

  8. Terrorists and Fair Trial: The Right to a Fair Trial for Alleged Terrorists Detained in Guantánamo Bay

    Directory of Open Access Journals (Sweden)

    Kai Ambos

    2013-09-01

    Full Text Available This paper inquires into whether the right to a fair trial can be restricted with regard to alleged terrorists within the framework of the ‘war on terror’. After briefly identifying the relevant sources of this right and its content, possible restrictions are analysed. The paper elaborates, in particular, on international humanitarian law, such as the Third and Fourth Geneva Convention, and international human rights law, such as the International Covenant on Civil and Political Rights and the American Declaration of the Rights and Duties of Man. It further deals with US constitutional law. We conclude that the right to a fair trial fully applies to alleged terrorists irrespective of the context of their detention (armed conflict or peace or the qualification of these terrorists (de facto or unlawful combatants and thus amounts to a general principle of transnational criminal law.

  9. Randomized Phase 2 Trial of S1 and Oxaliplatin-Based Chemoradiotherapy With or Without Induction Chemotherapy for Esophageal Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Yoon, Dok Hyun [Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Jang, Geundoo [Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Department of Internal Medicine, Hallym Medical Center, Hallym University College of Medicine, Seoul (Korea, Republic of); Kim, Jong Hoon [Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Kim, Yong-Hee [Department of Thoracic Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Kim, Ji Youn [Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Kim, Hyeong Ryul [Department of Thoracic Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Jung, Hwoon-Yong; Lee, Gin-Hyug [Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Song, Ho Young [Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Cho, Kyung-Ja [Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Ryu, Jin-Sook [Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Kim, Sung-Bae, E-mail: sbkim3@amc.seoul.kr [Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of)

    2015-03-01

    Purpose: To assess, in a randomized, phase 2 trial, the efficacy and safety of chemoradiotherapy with or without induction chemotherapy (ICT) of S1 and oxaliplatin for esophageal cancer. Patients and Methods: Patients with stage II, III, or IVA esophageal cancer were randomly allocated to either 2 cycles of ICT (oxaliplatin 130 mg/m{sup 2} on day 1 and S1 at 40 mg/m{sup 2} twice daily on days 1-14, every 3 weeks) followed by concurrent chemoradiotherapy (CCRT) (46 Gy, 2 Gy/d with oxaliplatin 130 mg/m{sup 2} on days 1 and 21 and S1 30 mg/m{sup 2} twice daily, 5 days per week during radiation therapy) and esophagectomy (arm A), or the same CCRT followed by esophagectomy without ICT (arm B). The primary endpoint was the pathologic complete response (pCR) rate. Results: A total of 97 patients were randomized (arm A/B, 47/50), 70 of whom underwent esophagectomy (arm A/B, 34/36). The intention-to-treat pCR rate was 23.4% (95% confidence interval [CI] 11.2-35.6%) in arm A and 38% (95% CI 24.5% to 51.5%) in arm B. With a median follow-up duration of 30.3 months, the 2-year progression-free survival rate was 58.4% in arm A and 58.6% in arm B, whereas the 2-year overall survival rate was 60.7% and 63.7%, respectively. Grade 3 or 4 thrombocytopenia during CCRT was more common in arm A than in arm B (35.4% vs 4.1%). The relative dose intensity of S1 (89.5% ± 20.6% vs 98.3% ± 5.2%, P=.005) and oxaliplatin (91.4% ± 16.8% vs 99.0% ± 4.2%, P=.007) during CCRT was lower in arm A compared with arm B. Three patients in arm A, compared with none in arm B, died within 90 days after surgery. Conclusions: Combination chemotherapy of S1 and oxaliplatin is an effective chemoradiotherapy regimen to treat esophageal cancer. However, we failed to show that the addition of ICT to the regimen can improve the pCR rate.

  10. Effects of hand clasping and arm folding on academic performance

    Institute of Scientific and Technical Information of China (English)

    Zhenxiang Zang; Zaizhu Han; Yufeng Zang

    2008-01-01

    BACKGROUND: Similar to handedness, hand clasping and arm folding are also lateral preferences.Previous studies showed a variation frequency for hand clasping and arm folding among different populations.OBJECTIVE: To investigate the relationship between patterns of lateral preferences (hand clasping or arm folding) and academic performance of middle school students.DESIGN, TIME AND SETTINGS: Cross-sectional investigation. The data were collected in the Beijing Zhongguancun High School in Beijing in May 2007. Data analysis was performed in the State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University during June to July 2007.PARTICIPANTS: A total of 102 senior-grade students from Beijing Zhongguancun High School, including 58 males and 44 females, were selected for this study.METHODS: Different forms of hand clasping and arm folding were recorded. More specifically, hand clasping was either right-thumb-top or left-thumb-top, and arm folding was either right-arm-top or left-arm-top. Students with congruent preference used right-thumb-top-right-arm-top or left-thumb-top-left-arm-top, and incongruent preference was displayed by right-thumb-top-left-arm-top or left-thumb-top-right-arm-top. Academic performances were collected from mid-term exams in six subjects (Chinese, Mathematics, English, Physics, Chemistry, and Biology), with a total points = 100 for each. A three-way (hand clasping, arm folding, and sex) ANOVA was performed to determine the effect on academic performances.MAIN OUTCOME MEASURES: The relationship between hand clasping, arm folding, sex, and academic performance of students.RESULTS: (1) There was no significant difference in distribution frequency between right-thumb-top and left-thumb-top (P > 0.05), or between right-arm-top and left-arm-top (P > 0.05). The distribution frequency difference between boys and girls was not significant for any subtype (P > 0.05). (2) hand clasping had no significant main effect on any of the

  11. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

    OpenAIRE

    O’Cathain, A.; Hoddinott, P.; Lewin, S; Thomas, K J; Young, B; Adamson, J.; Jansen, J.F.M.; Mills, N; Moore, G.; Donovan, J.L.

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full trial. We present guidance that researchers, research funders and reviewers may wish to consider when assessing or undertaking qualitative research within feasibility studies for randomised controll...

  12. Does explicit expectation really affect preparation?

    Directory of Open Access Journals (Sweden)

    Valentin J. Umbach

    2012-10-01

    Full Text Available Expectation enables preparation for an upcoming event and supports performance if the anticipated situation occurs, as manifested in behavioral effects (e.g., decreased RT. However, demonstrating coincidence between expectation and preparation is not sufficient for attributing a causal role to the former. The content of explicit expectation may simply reflect the present preparation state. We targeted this issue by experimentally teasing apart demands for preparation and explicit expectations. Expectations often originate from our experience: we expect that events occurring with a high frequency in the past are more likely to occur again. In addition to expectation, other task demands can feed into action preparation. In four experiments, frequency-based expectation was pitted against a selective response deadline. In a three-choice reaction time task, participants responded to stimuli that appeared with varying frequency (60%, 30%, 10%. Trial-by-trial stimulus expectations were either captured via verbal predictions or induced by visual cues. Predictions as well as response times quickly conformed to the variation in stimulus frequency. After two (of five experimental blocks we forced participants by selective time pressure to respond faster to a less frequent stimulus. Therefore, participants had to prepare for one stimulus (medium frequency while often explicitly expecting a different one (high frequency. Response times for the less frequent stimulus decreased immediately, while explicit expectations continued to indicate the (unchanged presentation frequencies. Explicit expectations were thus not just reflecting preparation. In fact, participants responded faster when the stimulus matched the trial-wise expectations, even when task demands discouraged their use. In conclusion, we argue that explicit expectation feeds into preparatory processes instead of being a mere by-product.

  13. Up-front fludarabine impairs stem cell harvest in multiple myeloma: report from an interim analysis of the NMSG 13/03 randomized placebo controlled phase II trial

    DEFF Research Database (Denmark)

    Johnsen, Hans Erik; Knudsen, Lene Meldgaard; Mylin, Anne Kærsgaard;

    2009-01-01

    The impact of chemotherapy resistant B cells in multiple myeloma (MM) needs to be evaluated by in vivo targeted therapy. Here we report the conclusions from a phase II randomized, placebo controlled trial adding fludarabine to the induction with cyclophosphamide-dexamethasone. Based on an interim...... toxicity and safety analysis, the trial was stopped following inclusion of 34 of a planned 80 patients due to a reduced number of patients (4/17) actually harvested in the experimental arm compared to the control arm (11/17; p lower than 0.05). In conclusion, the scheduled fludarabine dosage in 2 cycles...

  14. Up-front fludarabine impairs stem cell harvest in multiple myeloma: report of the NMSG 13/03 randomized placebo controlled phase II trial

    DEFF Research Database (Denmark)

    Johnsen, Hans E.; Meldgaard Knudsen, Lene; Mylin, Anne K.;

    2009-01-01

    The impact of chemotherapy resistant B cells in multiple myeloma (MM) needs to be evaluated by in vivo targeted therapy. Here we report the conlusions from a phase II randomized, placebo controlled trial adding fludarabine to the induction with cyclophosphamide-dexamethasone. Based on an interim...... toxicity and safety analysis, the trial was stopped following inclusion of 34 of a planned 80 patients due to a reduced number of patients (4/17) actually harvested in the experimental arm compared to the control arm (11/17; p

  15. Are we drawing the right conclusions from randomised placebo-controlled trials? A post-hoc analysis of data from a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Bone Kerry M

    2009-06-01

    Full Text Available Abstract Background Assumptions underlying placebo controlled trials include that the placebo effect impacts on all study arms equally, and that treatment effects are additional to the placebo effect. However, these assumptions have recently been challenged, and different mechanisms may potentially be operating in the placebo and treatment arms. The objective of the current study was to explore the nature of placebo versus pharmacological effects by comparing predictors of the placebo response with predictors of the treatment response in a randomised, placebo-controlled trial of a phytotherapeutic combination for the treatment of menopausal symptoms. A substantial placebo response was observed but no significant difference in efficacy between the two arms. Methods A post hoc analysis was conducted on data from 93 participants who completed this previously published study. Variables at baseline were investigated as potential predictors of the response on any of the endpoints of flushing, overall menopausal symptoms and depression. Focused tests were conducted using hierarchical linear regression analyses. Based on these findings, analyses were conducted for both groups separately. These findings are discussed in relation to existing literature on placebo effects. Results Distinct differences in predictors were observed between the placebo and active groups. A significant difference was found for study entry anxiety, and Greene Climacteric Scale (GCS scores, on all three endpoints. Attitude to menopause was found to differ significantly between the two groups for GCS scores. Examination of the individual arms found anxiety at study entry to predict placebo response on all three outcome measures individually. In contrast, low anxiety was significantly associated with improvement in the active treatment group. None of the variables found to predict the placebo response was relevant to the treatment arm. Conclusion This study was a post hoc analysis

  16. CHARACTERISTICS OF SPIRAL ARMS IN LATE-TYPE GALAXIES

    Energy Technology Data Exchange (ETDEWEB)

    Honig, Z. N.; Reid, M. J., E-mail: mreid@cfa.harvard.edu [Harvard-Smithsonian Center for Astrophysics, 60 Garden Street, Cambridge, MA 02138 (United States)

    2015-02-10

    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. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

    NARCIS (Netherlands)

    O’Cathain, A.; Hoddinott, P.; Lewin, S.; Thomas, K.J.; Young, B.; Adamson, J.; Jansen, J.F.M.; Mills, N.; Moore, G.; Donovan, J.L.

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full t

  19. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    Science.gov (United States)

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  20. BLIND TRIALS EVALUATING IN VITRO INFECTIVITY OF CRYPTOSPORIDIUM PARVUM OOCYSTS USING CELL CULTURE IMMUNOFLUORESCENCE

    Science.gov (United States)

    An optimized cell culture-immunofluorescence (IFA) procedure, using the HCT-8 cell line, was evaluated in 'blind' trials to determine the sensitivity and reproducibility for measuring infectivity of flow cytometry prepared inocula of C. parvum oocysts. In separate trials, suspens...

  1. Unit: Indicating Acidity, Inspection Pack, National Trial Print.

    Science.gov (United States)

    Australian Science Education Project, Toorak, Victoria.

    The introductory core activities in this trial unit, prepared for students in grades seven through nine of Australian schools, use indicators derived from flower pigments to provide a more convenient measure of acidity than taste. Students are offered choices among seven options after completion of the core: "How Acidic is That?"; "What Colour is…

  2. 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 ... experimental treatment on a small group of often healthy people (20 to 80), to judge its safety ...

  3. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... to find out if an 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 ... universities and medical centers across the country. The National Institutes of ...

  4. 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 ... to obtain preliminary data on whether the drug works in people who have a certain disease or ...

  5. The ONTARGET trial programme

    DEFF Research Database (Denmark)

    Unger, Thomas; Kintscher, Ulrich; Kappert, Kai;

    2009-01-01

    consisting of cardiovascular death, non-fatal stroke or myocardial infarction and hospitalisation for congestive heart failure. Patient selection and study procedures followed the previous HOPE trial. In the parallel TRANSCEND study, nearly 6.000 patients, all intolerant to ACE inhibition, were subjected...

  6. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  7. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... are usually described based on their phase. The U.S. Food and Drug Administration typically requires Phase 1, ... hundred to about 3,000 people. If the U.S. Food and Drug Administration agrees that the trial ...

  8. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... Reports Clinician Tools Clinician Tools Home Guidelines and Best Practices Topic Reviews Algorithms, Screens, Toolkits Provider Education Provider ... about federally and privately supported clinical research in human volunteers. Site gives information about a trial's purpose, who may participate, locations, and phone ... Forms State and Local Resources Strat Plan FY 2014-2020 VA Plans, Budget, & ...

  9. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A B; Smith, G;

    2016-01-01

    of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. METHODS: This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using...

  10. Phase I trial of thymidylate synthase poly-epitope peptide (TSPP) vaccine in advanced cancer patients.

    Science.gov (United States)

    Cusi, Maria Grazia; Botta, Cirino; Pastina, Pierpaolo; Rossetti, Maria Grazia; Dreassi, Elena; Guidelli, Giacomo Maria; Fioravanti, Antonella; Martino, Elodia Claudia; Gandolfo, Claudia; Pagliuchi, Marco; Basile, Assunta; Carbone, Salvatore Francesco; Ricci, Veronica; Micheli, Lucia; Tassone, Pierfrancesco; Tagliaferri, Pierosandro; Pirtoli, Luigi; Correale, Pierpaolo

    2015-09-01

    Thymidylate synthase (TS) poly-epitope peptide (TSPP) is a 27-mer peptide vaccine containing the amino acidic sequences of three epitopes with HLA-A2.1-binding motifs of TS, an enzyme overexpressed in cancer cells, which plays a crucial role in DNA repair and replication. Based on the results of preclinical studies, we designed a phase Ib trial (TSPP/VAC1) to investigate, in a dose escalation setting, the safety and the biological activity of TSPP vaccination alone (arm A) or in combination with GM-CSF and IL-2 (arm B) in cancer patients. Twenty-one pretreated metastatic cancer patients, with a good performance status (ECOG ≤ 1) and no severe organ failure or immunological disease, were enrolled in the study (12 in arm A, nine in arm B) between April 2011 and January 2012, with a median follow-up of 28 months. TSPP resulted safe, and its maximal tolerated dose was not achieved. No grade 4 toxicity was observed. The most common adverse events were grade 2 dermatological reactions to the vaccine injection, cough, rhinitis, fever, poly-arthralgia, gastro-enteric symptoms and, to a lesser extent, moderate hypertension and hypothyroidism. We detected a significant rise in auto-antibodies and TS-epitope-specific CTL precursors. Furthermore, TSPP showed antitumor activity in this group of pretreated patients; indeed, we recorded one partial response and seven disease stabilizations (SD) in arm A, and three SD in arm B. Taken together, our findings provide the framework for the evaluation of the TSPP anti-tumor activity in further disease-oriented clinical trials. PMID:26031574

  11. Effects of age, sex and arm on the accuracy of arm position sense – Left-arm superiority in healthy right-handers

    Directory of Open Access Journals (Sweden)

    Lena eSchmidt

    2013-12-01

    Full Text Available Position sense is an important proprioceptive ability. Disorders of arm position sense (APS often occur after unilateral stroke, and are associated with a negative functional outcome. In the present study we assessed horizontal APS by measuring angular deviations from a visually defined target separately for each arm in a large group of healthy subjects. We analyzed the accuracy and instability of horizontal APS as a function of age, sex and arm. Subjects were required to specify verbally the position of their unseen arm on a 0-90° circuit by comparing the current position with the target position indicated by a LED lamp, while the arm was passively moved by the examiner. Eighty-seven healthy subjects participated in the study, ranging from 20 to 77 years, subdivided into three age groups. The results revealed that APS was not a function of age or sex, but was significantly better in the non-dominant (left arm in absolute but not in constant errors across all age groups of right-handed healthy subjects. This indicates a right-hemisphere superiority for left arm position sense in right-handers and neatly fits to the more frequent and more severe left-sided body-related deficits in patients with unilateral stroke (i.e. impaired arm position sense in left spatial neglect, somatoparaphrenia or in individuals with abnormalities of the right cerebral hemisphere. These clinical issues will be discussed.

  12. Pediatric Physical Therapy in Infancy : From Nightmare to Dream? A Two-Arm Randomized Trial

    NARCIS (Netherlands)

    Blauw-Hospers, Cornill H.; Dirks, Tineke; Hulshof, Lily J.; Bos, Arend F.; Hadders-Algra, Mijna

    2011-01-01

    Background. Systematic reviews have suggested that early intervention by means of specific motor training programs and general developmental programs in which parents learn how to promote infant development may be the most promising ways to promote infant motor and cognitive development of infants w

  13. Pilates vs. Balance Training in Health Community-Dwelling Seniors: a 3-arm, Randomized Controlled Trial.

    Science.gov (United States)

    Donath, L; Roth, R; Hürlimann, C; Zahner, L; Faude, O

    2016-03-01

    The study examined effects of traditional balance vs. mat-based Pilates training on balance and trunk strength in healthy community dwellers. Forty-eight seniors were either stratified to a balance training group (BAL, n=16, 69.1 (SD 5.8) y), Pilates training group (PIL, n=17, 70.8 (6.5) y) or control group (CON, n=15, 69.2 (6.1) y). BAL performed traditional balance training, while PIL conducted mat-based Pilates-exercises (8 weeks, 2 sessions/week 66 min each). Balance performance (single limb stance and perturbed kneeling, Y-Balance test), dynamic and isometric trunk flexion and extension were assessed during pre- and post-testing. According to the magnitude-based inference approach, substantial positive effects in favor of BAL compared to CON were found for the Y-balance score (right leg, effect size (d)=0.68; left leg, d=0.56), trunk extension (d=0.68) and single leg stance (right leg, d=0.61; left leg, d=0.38). Dynamic (d=0.32) and isometric (d=0.15) trunk flexion revealed unclear effects. For the Y-balance score (right leg, d=0.48, left leg, d=0.75) and single leg stance (right leg, +d=0.61%; left leg, d=0.67), interestingly, BAL substantially exceeded PIL. PIL vs. CON revealed unclear effects for most parameters (0.05Pilates training did not cause relevant adaptations in trunk strength and balance performance, whereas balance training substantially improved balance and trunk strength. PMID:26630547

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

    Directory of Open Access Journals (Sweden)

    Poh Catherine F

    2011-10-01

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

  15. Predictors of primary care referrals to a vascular disease prevention lifestyle program among participants in a cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Passey Megan E

    2012-08-01

    Full Text Available Abstract Background Cardiovascular disease accounts for a large burden of disease, but is amenable to prevention through lifestyle modification. This paper examines patient and practice predictors of referral to a lifestyle modification program (LMP offered as part of a cluster randomised controlled trial (RCT of prevention of vascular disease in primary care. Methods Data from the intervention arm of a cluster RCT which recruited 36 practices through two rural and three urban primary care organisations were used. In each practice, 160 eligible high risk patients were invited to participate. Practices were randomly allocated to intervention or control groups. Intervention practice staff were trained in screening, motivational interviewing and counselling and encouraged to refer high risk patients to a LMP involving individual and group sessions. Data include patient surveys; clinical audit; practice survey on capacity for preventive care; referral records from the LMP. Predictors of referral were examined using multi-level logistic regression modelling after adjustment for confounding factors. Results Of 301 eligible patients, 190 (63.1% were referred to the LMP. Independent predictors of referral were baseline BMI ≥ 25 (OR 2.87 95%CI:1.10, 7.47, physical inactivity (OR 2.90 95%CI:1.36,6.14, contemplation/preparation/action stage of change for physical activity (OR 2.75 95%CI:1.07, 7.03, rural location (OR 12.50 95%CI:1.43, 109.7 and smaller practice size (1–3 GPs (OR 16.05 95%CI:2.74, 94.24. Conclusions Providing a well-structured evidence-based lifestyle intervention, free of charge to patients, with coordination and support for referral processes resulted in over 60% of participating high risk patients being referred for disease prevention. Contrary to expectations, referrals were more frequent from rural and smaller practices suggesting that these practices may be more ready to engage with these programs. Trial registration ACTRN

  16. Sustained Uptake of a Hospital-Based Handwashing with Soap and Water Treatment Intervention (Cholera-Hospital-Based Intervention for 7 Days [CHoBI7]): A Randomized Controlled Trial.

    Science.gov (United States)

    George, Christine Marie; Jung, Danielle S; Saif-Ur-Rahman, K M; Monira, Shirajum; Sack, David A; Mahamud-ur Rashid; Mahmud, Md Toslim; Mustafiz, Munshi; Rahman, Zillur; Bhuyian, Sazzadul Islam; Winch, Peter J; Leontsini, Elli; Perin, Jamie; Begum, Farzana; Zohura, Fatema; Biswas, Shwapon; Parvin, Tahmina; Sack, R Bradley; Alam, Munirul

    2016-02-01

    Diarrhea is the second leading cause of death in children under 5 years of age globally. The time patients and caregivers spend at a health facility for severe diarrhea presents the opportunity to deliver water, sanitation, and hygiene (WASH) interventions. We recently developed Cholera-Hospital-Based Intervention for 7 days (CHoBI7), a 1-week hospital-based handwashing with soap and water treatment intervention, for household members of cholera patients. To investigate if this intervention could lead to sustained WASH practices, we conducted a follow-up evaluation of 196 intervention household members and 205 control household members enrolled in a randomized controlled trial of the CHoBI7 intervention 6 to 12 months post-intervention. Compared with the control arm, the intervention arm had four times higher odds of household members' handwashing with soap at a key time during 5-hour structured observation (odds ratio [OR]: 4.71, 95% confidence interval [CI]: 2.61, 8.49) (18% versus 50%) and a 41% reduction in households in the World Health Organization very high-risk category for stored drinking water (OR: 0.38, 95% CI: 0.15, 0.96) (58% versus 34%) 6 to 12 months post-intervention. Furthemore, 71% of observed handwashing with soap events in the intervention arm involved the preparation and use of soapy water, which was promoted during the intervention, compared to 9% of control households. These findings demonstrate that the hospital-based CHoBI7 intervention can lead to significant increases in handwashing with soap practices and improved stored drinking water quality 6 to 12 months post-intervention. PMID:26728766

  17. Sustained Uptake of a Hospital-Based Handwashing with Soap and Water Treatment Intervention (Cholera-Hospital-Based Intervention for 7 Days [CHoBI7]): A Randomized Controlled Trial.

    Science.gov (United States)

    George, Christine Marie; Jung, Danielle S; Saif-Ur-Rahman, K M; Monira, Shirajum; Sack, David A; Mahamud-ur Rashid; Mahmud, Md Toslim; Mustafiz, Munshi; Rahman, Zillur; Bhuyian, Sazzadul Islam; Winch, Peter J; Leontsini, Elli; Perin, Jamie; Begum, Farzana; Zohura, Fatema; Biswas, Shwapon; Parvin, Tahmina; Sack, R Bradley; Alam, Munirul

    2016-02-01

    Diarrhea is the second leading cause of death in children under 5 years of age globally. The time patients and caregivers spend at a health facility for severe diarrhea presents the opportunity to deliver water, sanitation, and hygiene (WASH) interventions. We recently developed Cholera-Hospital-Based Intervention for 7 days (CHoBI7), a 1-week hospital-based handwashing with soap and water treatment intervention, for household members of cholera patients. To investigate if this intervention could lead to sustained WASH practices, we conducted a follow-up evaluation of 196 intervention household members and 205 control household members enrolled in a randomized controlled trial of the CHoBI7 intervention 6 to 12 months post-intervention. Compared with the control arm, the intervention arm had four times higher odds of household members' handwashing with soap at a key time during 5-hour structured observation (odds ratio [OR]: 4.71, 95% confidence interval [CI]: 2.61, 8.49) (18% versus 50%) and a 41% reduction in households in the World Health Organization very high-risk category for stored drinking water (OR: 0.38, 95% CI: 0.15, 0.96) (58% versus 34%) 6 to 12 months post-intervention. Furthemore, 71% of observed handwashing with soap events in the intervention arm involved the preparation and use of soapy water, which was promoted during the intervention, compared to 9% of control households. These findings demonstrate that the hospital-based CHoBI7 intervention can lead to significant increases in handwashing with soap practices and improved stored drinking water quality 6 to 12 months post-intervention.

  18. The development of fabrication techniques for europia/iron cermets tips for coarse control arms in Dido and Pluto

    International Nuclear Information System (INIS)

    The applicability of cermet-fabrication techniques to the production of europia/iron cermets for use as coarse-control arm tips in the materials test reactors DIDO and PLUTO has been investigated. Spheroids of europia were prepared by a dry agglomeration process. These were sintered, dispersed in iron powder and pressed into plates; the plates were then sintered to densify the iron matrix. These stages were optimised to produce a strong cermet with a europia density of 2.75 g/cm3. The uniformity of distribution of the absorber particles was confirmed by radiography, and adequate neutron-absorption worth by measurements carried out in the GLEEP reactor. An outline flow sheet has been prepared for the manufacture of europia/iron cermet plates suitable for use in the tips of DIDO and PLUTO coarse-control arms. (U.K.)

  19. Randomized phase III trial (GORTEC 98-03) comparing re-irradiation plus chemotherapy versus methotrexate in patients with recurrent or a second primary head and neck squamous cell carcinoma, treated with a palliative intent

    International Nuclear Information System (INIS)

    Purpose: This randomized phase III trial investigated the potential benefit of concurrent re-irradiation, fluorouracil and hydroxyurea versus methotrexate for patients treated with palliative intent for recurrent or second primary head and neck squamous cell carcinoma (HNSCC) in previously irradiated area. Patients and methods: Patients with recurrent HNSCC or a second primary not amenable to curative-intent treatment were randomized to the R-RT arm (concurrent re-irradiation, fluorouracil and hydroxyurea) or to the Ch-T arm (methotrexate). The primary endpoint was overall survival (OS). Due to a very slow accrual, the trial was closed after inclusion of 57 patients. Results: Fifty-seven patients were included. All patients died in the two arms with a maximal follow-up of 5 years. Although four complete responses were achieved in R-RT arm, (none in Ch-T arm) re-irradiation did not improve OS compared with methotrexate (23% versus 22% at 1 year, NS). Sixteen patients experienced clinical grade ≥3 late toxicities (>6 months), 11 in R-RT arm and five in Ch-T arm. Conclusions: Premature discontinuation of the trial did not allow us to draw firm conclusions. However, there was no suggestion that concurrent re-irradiation, fluorouracil and hydroxyurea improved OS compared to methotrexate alone in patients treated with palliative intent for a recurrent or second primary HNSCC.

  20. Augmented case-only designs for randomized clinical trials with failure time endpoints.

    Science.gov (United States)

    Dai, James Y; Zhang, Xinyi Cindy; Wang, Ching-Yun; Kooperberg, Charles

    2016-03-01

    Under suitable assumptions and by exploiting the independence between inherited genetic susceptibility and treatment assignment, the case-only design yields efficient estimates for subgroup treatment effects and gene-treatment interaction in a Cox model. However it cannot provide estimates of the genetic main effect and baseline hazards, that are necessary to compute the absolute disease risk. For two-arm, placebo-controlled trials with rare failure time endpoints, we consider augmenting the case-only design with random samples of controls from both arms, as in the classical case-cohort sampling scheme, or with a random sample of controls from the active treatment arm only. The latter design is motivated by vaccine trials for cost-effective use of resources and specimens so that host genetics and vaccine-induced immune responses can be studied simultaneously in a bigger set of participants. We show that these designs can identify all parameters in a Cox model and that the efficient case-only estimator can be incorporated in a two-step plug-in procedure. Results in simulations and a data example suggest that incorporating case-only estimators in the classical case-cohort design improves the precision of all estimated parameters; sampling controls only in the active treatment arm attains a similar level of efficiency.

  1. Design of Treatment Trials for Functional Gastrointestinal Disorders.

    Science.gov (United States)

    Irvine, E Jan; Tack, Jan; Crowell, Michael D; Gwee, Kok Ann; Ke, Meiyun; Schmulson, Max J; Whitehead, William E; Spiegel, Brennan

    2016-05-01

    This article summarizes recent progress and regulatory guidance on design of trials to assess the efficacy of new therapies for functional gastrointestinal disorders (FGIDs). The double-masked, placebo-controlled, parallel-group design remains the accepted standard for evaluating treatment efficacy. A control group is essential, and a detailed description of the randomization process and concealed allocation method must be included in the study report. The control will most often be placebo, but for therapeutic procedures and for behavioral treatment trials, respectively, a sham procedure and control intervention with similar expectation of benefit, but lacking the treatment principle, are recommended. Investigators should be aware of, and attempt to minimize, expectancy effects (placebo, nocebo, precebo). The primary analysis should be based on the proportion of patients in each treatment arm who satisfy a treatment responder definition or a prespecified clinically meaningful change in a patient-reported outcome measure. Data analysis should use the intention-to-treat principle. Reporting of results should follow the Consolidated Standards for Reporting Trials guidelines and include secondary outcome measures to support or explain the primary outcome and an analysis of harms data. Trials should be registered in a public location before initiation and results should be published regardless of outcome. PMID:27147123

  2. First generation leishmaniasis vaccines: a review of field efficacy trials.

    Science.gov (United States)

    Noazin, Sassan; Modabber, Farrokh; Khamesipour, Ali; Smith, Peter G; Moulton, Lawrence H; Nasseri, Kiumarss; Sharifi, Iraj; Khalil, Eltahir A G; Bernal, Ivan Dario Velez; Antunes, Carlos M F; Kieny, Marie Paule; Tanner, Marcel

    2008-12-01

    First generation candidate vaccines against leishmaniasis, prepared using inactivated whole parasites as their main ingredient, were considered as promising because of their relative ease of production and low cost. These vaccines have been the subject of many investigations over several decades and are the only leishmaniasis vaccine candidates which have undergone phase 3 clinical trial evaluation. Although the studies demonstrated the safety of the vaccines and several studies showed reasonable immunogenicity and some indication of protection, an efficacious prophylactic vaccine is yet to be identified. Despite this overall failure, these trials contributed significantly to increasing knowledge on human leishmaniasis immunology. To provide a collective view, this review discusses the methods and findings of field efficacy trials of first generation leishmaniasis vaccine clinical trials conducted in the Old and New Worlds.

  3. The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitisA and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitisB in perforated diverticulitis (NTR2037

    Directory of Open Access Journals (Sweden)

    Bruin Sjoerd C

    2010-10-01

    Full Text Available Abstract Background Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy. The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis. Methods/Design In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm. Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm. The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%. Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power = 90% in favour of the patients with resection with primary anastomosis. Secondary endpoints for both arms are the number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs. Discussion The Ladies trial is a nationwide multicentre randomised trial on perforated diverticulitis that will provide evidence on the merits of laparoscopic lavage and drainage for purulent generalised peritonitis and on the optimal resectional strategy

  4. HIV/AIDS Clinical Trials

    Science.gov (United States)

    ... Home Apps APIs Widgets Order Publications Skip Nav HIV/AIDS Clinical Trials Home > Clinical Trials Español small ... Renal (Kidney) Complications/Damage Skin Diseases FDA-Approved HIV Drugs Abacavir Atazanavir Atripla Cobicistat Combivir Complera Darunavir ...

  5. Cognitive benefits of social dancing and walking in old age: the Dancing Mind randomized controlled trial

    OpenAIRE

    Dafna eMerom; Anne eGrunseit; Ranmalee eEramudugolla; Barbarra eJefferis; Jade eMcneil; Anstey, Kaarin J

    2016-01-01

    Background: A physically active lifestyle has the potential to prevent cognitive decline and dementia, yet the optimal type of physical activity/exercise remains unclear. Dance is of special interest as it complex sensorimotor rhythmic activity with additional cognitive, social and affective dimensions. Objectives: to determine whether dance benefits executive function more than walking, an activity that is simple and functional. Methods: Two-arm randomised controlled trial among community-d...

  6. Cognitive Benefits of Social Dancing and Walking in Old Age: The Dancing Mind Randomized Controlled Trial

    OpenAIRE

    Merom, Dafna; Grunseit, Anne; Eramudugolla, Ranmalee; Jefferis, Barbara; McNeill, Jade; Anstey, Kaarin J

    2016-01-01

    Background A physically active lifestyle has the potential to prevent cognitive decline and dementia, yet the optimal type of physical activity/exercise remains unclear. Dance is of special interest as it complex sensorimotor rhythmic activity with additional cognitive, social, and affective dimensions. Objectives To determine whether dance benefits executive function more than walking, an activity that is simple and functional. Methods Two-arm randomized controlled trial a...

  7. Finasteride Concentrations and Prostate Cancer Risk: Results from the Prostate Cancer Prevention Trial

    OpenAIRE

    Chau, Cindy H.; Price, Douglas K.; Cathee Till; Goodman, Phyllis J.; Xiaohong Chen; Leach, Robin J; Johnson-Pais, Teresa L.; Hsing, Ann W.; Ashraful Hoque; Tangen, Catherine M.; Lisa Chu; Parnes, Howard L.; Schenk, Jeannette M.; Reichardt, Juergen K. V.; Thompson, Ian M

    2015-01-01

    Objective In the Prostate Cancer Prevention Trial (PCPT), finasteride reduced the risk of prostate cancer by 25%, even though high-grade prostate cancer was more common in the finasteride group. However, it remains to be determined whether finasteride concentrations may affect prostate cancer risk. In this study, we examined the association between serum finasteride concentrations and the risk of prostate cancer in the treatment arm of the PCPT and determined factors involved in modifying dru...

  8. Effectiveness of occupational therapy in Parkinson’s disease: study protocol for a randomized controlled trial

    OpenAIRE

    Sturkenboom, I.H.W.M.; Graff, M.J.L.; Borm, G.F.; Adang, E.M.M.; Nijhuis-Van der Sanden, M.W.G.; Bloem, B R.; Munneke, M.

    2013-01-01

    BACKGROUND: Occupational therapists may have an added value in the care of patients with Parkinson's disease whose daily functioning is compromised, as well as for their immediate caregivers. Evidence for this added value is inconclusive due to a lack of rigorous studies. The aim of this trial is to evaluate the (cost) effectiveness of occupational therapy in improving daily functioning of patients with Parkinson's disease. METHODS/DESIGN: A multicenter, assessor-blinded, two-armed randomized...

  9. Which dressing do donor site wounds need?: study protocol for a randomized controlled trial

    OpenAIRE

    Ubbink Dirk T; Gerbens Louise AA; Brölmann Fleur E; Eskes Anne M; Vermeulen Hester

    2011-01-01

    Abstract Background Donor site wounds after split-skin grafting are rather 'standard' wounds. At present, lots of dressings and topical agents for donor site wounds are commercially available. This causes large variation in the local care of these wounds, while the optimum 'standard' dressing for local wound care is unclear. This protocol describes a trial in which we investigate the effectiveness of various treatment options for these donor site wounds. Methods A 14-center, six-armed randomi...

  10. Intervention randomized controlled trials involving wrist and shoulder arthroscopy: a systematic review

    OpenAIRE

    Tadjerbashi, Kamelia; Rosales, Roberto S; Atroshi, Isam

    2014-01-01

    Background: Although arthroscopy of upper extremity joints was initially a diagnostic tool, it is increasingly used for therapeutic interventions. Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. We aimed to review the literature for intervention RCTs involving wrist and shoulder arthroscopy. Methods: We performed a systematic review for RCTs in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arth...

  11. A method for measurement of static lever arm

    Science.gov (United States)

    Ma, Xianglu; Qin, Shiqiao; Wang, Xingshu; Wu, Wei; Hu, Feng; Zheng, JiaXing

    2016-01-01

    Lever arm effect has to be considered in transfer alignment technology. Between static lever arm and dynamic lever arm, the former has larger amplitude, and it is the major error source in transfer alignment. How to measure and solve it become an important problem. This paper takes vehicle as a rigid body. Assume that static lever arm does not change in a short time, based on two inertial measurement units(IMU), data are measured and constituted several matrixes properly. After that, by using least square method, static lever arm is solved finally. Simulation experiments are implemented, results show that static lever arm can be solved effectively. Further study shows that, the precision of the method can be improved by preprocessing low pass filter.

  12. Kootenay Lake Fertilization Experiment, Year 15 (North Arm) and Year 3 (South Arm) (2006) Report

    Energy Technology Data Exchange (ETDEWEB)

    Schindler, E.U.; Sebastian, D.; Andrusak, G.F. [Fish and Wildlife Science and Allocation, Ministry of Environment, Province of British Columbia

    2009-07-01

    This report summarizes results from the fifteenth year (2006) of nutrient additions to the North Arm of Kootenay Lake and three years of nutrient additions to the South Arm. Experimental fertilization of the lake has been conducted using an adaptive management approach in an effort to restore lake productivity lost as a result of nutrient uptake in upstream reservoirs. The primary objective of the experiment is to restore kokanee (Oncorhynchus nerka) populations, which are the main food source for Gerrard rainbow trout (Oncorhynchus mykiss) and bull trout (Salvelinus confluentus). The quantity of agricultural grade liquid fertilizer (10-34-0, ammonium polyphosphate and 28-0-0, urea ammonium nitrate) added to the North Arm in 2006 was 44.7 tonnes of P and 248.4 tonnes of N. The total fertilizer load added to the South Arm was 257 tonnes of nitrogen; no P was added. Kootenay Lake has an area of 395 km{sup 2}, a maximum depth of 150 m, a mean depth of 94 m, and a water renewal time of approximately two years. Kootenay Lake is a monomictic lake, generally mixing from late fall to early spring and stratifying during the summer. Surface water temperatures generally exceed 20 C for only a few weeks in July. Results of oxygen profiles were similar to previous years with the lake being well oxygenated from the surface to the bottom depths at all stations. Similar to past years, Secchi disc measurements at all stations in 2006 indicate a typical seasonal pattern of decreasing depths associated with the spring phytoplankton bloom, followed by increasing depths as the bloom gradually decreases by the late summer and fall. Total phosphorus (TP) ranged from 2-7 {micro}g/L and tended to decrease as summer advanced. Over the sampling season dissolved inorganic nitrogen (DIN) concentrations decreased, with the decline corresponding to nitrate (the dominant component of DIN) being utilized by phytoplankton during summer stratification. Owing to the importance of epilimnetic nitrate

  13. Female Sprague Dawley Rats Show Impaired Spatial Memory in the 8-Arm Radial Maze under Dim Blue and Red Light

    Directory of Open Access Journals (Sweden)

    Michael Pirchl

    2010-01-01

    Full Text Available Light intensity and wavelength strongly influence mood and cognition in humans and rodent animal models. The aim of the present study was to explore if dim white (7.6–17.7 lux , blue (1.3–2.3 lux, and red light (0.8–1.4 lux affect spatial memory of male and female Sprague Dawley rats in the 8-arm radial maze. Our data show that spatial memory significantly improved within 5 daily learning sessions (each 5 trials under dim white light, which was not different between male and female rats. However, dim blue and red light significantly reduced spatial learning of female rats in the 8-arm radial maze in the last training session (session 5. In conclusion, we suggest that female Sprague Dawley rats show reduced learning under blue and red light.

  14. “I Want That”: Human-in-the-Loop Control of a Wheelchair-Mounted Robotic Arm

    Directory of Open Access Journals (Sweden)

    Katherine M. Tsui

    2011-01-01

    Full Text Available Wheelchair-mounted robotic arms have been commercially available for a decade. In order to operate these robotic arms, a user must have a high level of cognitive function. Our research focuses on replacing a manufacturer-provided, menu-based interface with a vision-based system while adding autonomy to reduce the cognitive load. Instead of manual task decomposition and execution, the user explicitly designates the end goal, and the system autonomously retrieves the object. In this paper, we present the complete system which can autonomously retrieve a desired object from a shelf. We also present the results of a 15-week study in which 12 participants from our target population used our system, totaling 198 trials.

  15. Hemispace asymmetries and laterality effects in arm positioning.

    Science.gov (United States)

    Imanaka, K; Abernethy, B; Yamauchi, M; Funase, K; Nishihira, Y

    1995-12-01

    Hemispace asymmetries and laterality effects were examined on an arm positioning reproduction task. Sixteen male subjects were asked to reproduce both abductive and adductive positioning movements with the left or right arm within either the left or the right hemispace. Hemispace was manipulated using a 90 degrees head-rotation paradigm. A left hemispace advantage in positioning accuracy was predicted for both left and right arm movements on the grounds that the perceptual-motor control of positioning movements made in left hemispace is primarily mediated by the right hemisphere which is known to be advantageous for tasks which are spatial in nature (Heilman, Bowers, & Watson, 1984). No arm laterality effects were predicted to occur because the proximal musculature involved in the control of arm movements is innervated from both contralateral and ipsilateral cerebral hemispheres (Brinkman & Kuypers, 1973). Results showed that the predicted left hemispace advantage was evident for the right arm on the positioning variability measure alone, whereas it was absent for all other possible conditions on all error measures. Laterality (arm) effects were absent as predicted. The experiment also demonstrated a greater degradation of reproduction performance under the "crossed" arm-hemispace conditions than under the "uncrossed" conditions. A plausible explanation for the uncrossed advantage for the task is that under normal conditions, a single hemisphere is primarily responsible for both controlling the contralateral arm and directing attention to the contralateral hemispace, and consequently potential interhemispheric interference is minimized. A clear response bias effect in movement reproduction was also evident as a function of the direction of concurrent arm movement and head rotation. Arm movements made in the same direction as head rotation were systematically undershot in reproduction to a much greater degree than arm movements made in the opposite direction to head

  16. Naval trends in ASEAN: is there a new arms race?

    OpenAIRE

    Jones, Frank Curtis

    1995-01-01

    Global military spending is decreasing. However this trend does not apply to some regions of the world, specifically Southeast Asia. This thesis describes the ongoing naval arms buildup in this region and examines why it is occurring when the rest of the world is decreasing military spending. Next, this thesis asks if this arms build-up is dangerous. Unlike many other arms races around the world, the Southeast Asian build-up is not particularly dangerous because of the parallel development of...

  17. THE POSITION OF RUSSIA IN THE WORLD ARMS MARKETS

    OpenAIRE

    Tuliakova I.R.

    2015-01-01

    The article is devoted to the role of Russia in the world arms market. Two world wars and arms race of the late twentieth century led to the formation of the defense- industrial complex. Russian military products are exported to many countries. Currently, Russia is the main supplier of arms to the world market. But there are serious limits to the expansion of military production

  18. ARM Operations and Engineering Procedure Mobile Facility Site Startup

    Energy Technology Data Exchange (ETDEWEB)

    Voyles, Jimmy W

    2015-05-01

    This procedure exists to define the key milestones, necessary steps, and process rules required to commission and operate an Atmospheric Radiation Measurement (ARM) Mobile Facility (AMF), with a specific focus toward on-time product delivery to the ARM Data Archive. The overall objective is to have the physical infrastructure, networking and communications, and instrument calibration, grooming, and alignment (CG&A) completed with data products available from the ARM Data Archive by the Operational Start Date milestone.

  19. Stronger than Justice : Armed Group Impunity for Sexual Violence

    OpenAIRE

    Muvumba Sellström, Angela

    2015-01-01

    What conditions lead to confidence among civil war combatants that they will not face accountability for perpetrating sexual violence? This study investigates the causes of impunity for sexual violence among armed actors. It develops a theoretical framework which identifies three explanations for armed group impunity for sexual violence, namely (1) flawed prohibitions inside an armed group; (2) negligent enforcement by its authorities; and (3) pardons in the form of amnesties during the peace...

  20. Gravitoinertial force level influences arm movement control

    Science.gov (United States)

    Fisk, J.; Lackner, J. R.; DiZio, P.

    1993-01-01

    1. The ability to move the forearm between remembered elbow joint angles immediately after rapid increases or decreases of the background gravitoinertial force (G) level was measured. The movements had been well-practiced in a normal 1G environment before the measurements in high-(1.8G) and low-force (0G) environments. The forearm and upper arm were always unsupported to maximize the influence of altered G-loading and to minimize extraneous cues about arm position. 2. Horizontal and vertical movement planes were studied to measure the effects of varying the G load in the movement plane within a given G background. Rapid and slow movements were studied to assess the role of proprioceptive feedback. 3. G level did not affect the amplitude of rapid movements, indicating that subjects were able to plan and to generate appropriate motor commands for the new G loading of the arm. The amplitude of slow movements was affected by G level, indicating that proprioceptive feedback is influenced by G level. 4. The effects of G level were similar for horizontal and vertical movements, indicating that proprioceptive information from supporting structures, such as the shoulder joint and muscles, had a role in allowing generation of the appropriate motor commands. 5. The incidence and size of dynamic overshoots were greater in 0G and for rapid movements. This G-related change in damping suggests a decrease in muscle spindle activity in 0G. A decrease in muscle spindle activity in 0G and an increase in 1.8G are consistent with the results of our prior studies on the tonic vibration reflex, locomotion, and perception of head movement trajectory in varying force backgrounds.

  1. The Trial of Katherine Harrison.

    Science.gov (United States)

    Woodward, Walter W.

    2003-01-01

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

  2. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

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

    2015-01-01

    starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...

  3. Well ARMed and FiRM

    DEFF Research Database (Denmark)

    Rasmussen, Kourosh Marjani; Zenios, Stavros A.

    2007-01-01

    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 particularly so if one......Individual homeowners are offered today a wide range of mortgage options for financing the purchase of a house. Usually, homeowners are also granted an option to repay the mortgage loan, and in some countries - such as Denmark - it is particularly efficient to do so as market conditions change...

  4. Upper arm elevation and repetitive shoulder movements

    DEFF Research Database (Denmark)

    Dalbøge, Annett; Hansson, Gert-Åke; Frost, Poul;

    2016-01-01

    OBJECTIVES: We recently constructed a general population job exposure matrix (JEM), The Shoulder JEM, based on expert ratings. The overall aim of this study was to convert expert-rated job exposures for upper arm elevation and repetitive shoulder movements to measurement scales. METHODS: The...... Spearman rank correlations and the explained variance[Formula: see text] according to linear regression analyses (36 job groups). We used the linear regression equations to convert the expert-rated job exposures for all 172 job groups into predicted measured job exposures. Bland-Altman analyses were used...

  5. ARM CLASIC ER2 CRS/EDOP

    Energy Technology Data Exchange (ETDEWEB)

    Gerald Heymsfield

    2010-12-20

    Data was taken with the NASA ER-2 aircraft with the Cloud Radar System and other instruments in conjunction with the DOE ARM CLASIC field campaign. The flights were near the SGP site in north Central Oklahoma and targeted small developing convection. The CRS is a 94 GHz nadir pointing Doppler radar. Also on board the ER-2 was the Cloud Physics Lidar (CPL). Seven science flights were conducted but the weather conditions did not cooperate in that there was neither developing convection, or there was heavy rain.

  6. ANALIZA KOMUNIKACIJSKIH PROTOKOLOV NA PLATFORMI ARM

    OpenAIRE

    Vegan, Janez

    2015-01-01

    Magistrsko delo obravnava zajem, analizo in prikaz signalov različnih komunikacijskih protokolov v realnem času. Podrobno so predstavljena strojna in programska oprema ter razvojna okolja, s pomočjo katerih smo realizirali sistem za analizo protokolov. V okviru magistrskega dela smo razvili program za platformo ARM, ki na LCD-zaslonu v realnem času prikazuje vsebino zajetih podatkov po protokolih IR (SIRC, NEC, RC6), I2C, SPI in UART. Razvili smo tudi program za stm32F100, ki oddaja v protoko...

  7. 'Great power' intervention in African armed conflicts

    DEFF Research Database (Denmark)

    Olsen, Gorm Rye

    2015-01-01

    to contribute to understanding the changing geopolitical environment and the current conditions for conflict management in Africa. The focus is not on trade and aid. The paper launches the hypothesis that the explanations why the US, China and the EU have intervened are basically identical. In spite......This paper asks why the United States (US), China and the European Union (EU) have intervened in a number of armed conflicts in Africa in the twenty-first century. Scrutiny and comparison of the motivations and interests of the three non-African actors in intervening in African crises are assumed...

  8. ARM assembly language fundamentals and techniques

    CERN Document Server

    Hohl, William

    2009-01-01

    Written by the director of ARM's worldwide academic program, this volume gives computer science professionals and students an edge, regardless of their preferred coding language. For those with some basic background in digital logic and high-level programming, the book examines code relevant to hardware and peripherals found on today's microcontrollers and looks at situations all programmers will eventually encounter. The book's carefully chosen examples teach easily transferrable skills that will help readers optimize routines and significantly streamline coding, especially in the embedded sp

  9. HS06 Benchmark for an ARM Server

    Science.gov (United States)

    Kluth, Stefan

    2014-06-01

    We benchmarked an ARM cortex-A9 based server system with a four-core CPU running at 1.1 GHz. The system used Ubuntu 12.04 as operating system and the HEPSPEC 2006 (HS06) benchmarking suite was compiled natively with gcc-4.4 on the system. The benchmark was run for various settings of the relevant gcc compiler options. We did not find significant influence from the compiler options on the benchmark result. The final HS06 benchmark result is 10.4.

  10. HS06 Benchmark for an ARM Server

    CERN Document Server

    Kluth, Stefan

    2013-01-01

    We benchmarked an ARM cortex-A9 based server system with a four-core CPU running at 1.1 GHz. The system used Ubuntu 12.04 as operating system and the HEPSPEC 2006 (HS06) benchmarking suite was compiled natively with gcc-4.4 on the system. The benchmark was run for various settings of the relevant gcc compiler options. We did not find significant influence from the compiler options on the benchmark result. The final HS06 benchmark result is 10.4.

  11. The professionalisation of the Netherlands armed force

    OpenAIRE

    Van Veldhuizen-Rothenbuecher, Ida

    2001-01-01

    The fall of the Berlin Wall and the end of the Cold War led in 1991 to the decision to gradually reduce and restructure the Netherlands armed forces. It was process consisting of dozens of reorganisations. The idea was that the reorganisation and reduction would go hand in hand, not only operationally but also financially. Firstly, only one in three men were actually still called up in order to fulfil conscription duties lasting more or less a year. There was one more condition for the transf...

  12. Age and disease at an arms length

    DEFF Research Database (Denmark)

    Lassen, Aske Juul

    How are the boundaries of disease and health, age, life and death negotiated through technology and active aging? The paper focuses on how disease and age are dealt with by active elderly at activity centres in the Copenhagen area. New health technologies lead to new expectations to the longevity...... a chronic (previously fatal) disease. The active elderly often stick to their image of themselves as active, youthful and energetic in spite of a chronic disease. Old age and disease is not what they identify with and seems to be conceived at an arms length. In the paper the author explores how health...

  13. Simulation of Octopus Arm Based on Coupled CPGs

    Directory of Open Access Journals (Sweden)

    Juan Tian

    2015-01-01

    Full Text Available The octopus arm has attracted many researchers’ interests and became a research hot spot because of its amazing features. Several dynamic models inspired by an octopus arm are presented to realize the structure with a large number of degrees of freedom. The octopus arm is made of a soft material introducing high-dimensionality, nonlinearity, and elasticity, which makes the octopus arm difficult to control. In this paper, three coupled central pattern generators (CPGs are built and a 2-dimensional dynamic model of the octopus arm is presented to explore possible strategies of the octopus movement control. And the CPGs’ signals treated as activation are added on the ventral, dorsal, and transversal sides, respectively. The effects of the octopus arm are discussed when the parameters of the CPGs are changed. Simulations show that the octopus arm movements are mainly determined by the shapes of three CPGs’ phase diagrams. Therefore, some locomotion modes are supposed to be embedded in the neuromuscular system of the octopus arm. And the octopus arm movements can be achieved by modulating the parameters of the CPGs. The results are beneficial for researchers to understand the octopus movement further.

  14. Design and Engineering of a Chess-Robotic Arm

    CERN Document Server

    Elouafiq, Ali

    2012-01-01

    In the scope of the "Chess-Bot" project, this study's goal is to choose the right model for the robotic arm that the "the Chess-Bot" will use to move the pawn from a cell to another. In this paper, there is the definition and the structure of a robot arm. Also, the different engineering and kinematics fundamentals of the robot and its components will be detailed. Furthermore, the different structures of robotic arms will be presented and compared based on different criteria. Finally, a model for "the Chess-Bot" arm will be synthesized based on accurate algorithms and equations.

  15. System For Research On Multiple-Arm Robots

    Science.gov (United States)

    Backes, Paul G.; Hayati, Samad; Tso, Kam S.; Hayward, Vincent

    1991-01-01

    Kali system of computer programs and equipment provides environment for research on distributed programming and distributed control of coordinated-multiple-arm robots. Suitable for telerobotics research involving sensing and execution of low level tasks. Software and configuration of hardware designed flexible so system modified easily to test various concepts in control and programming of robots, including multiple-arm control, redundant-arm control, shared control, traded control, force control, force/position hybrid control, design and integration of sensors, teleoperation, task-space description and control, methods of adaptive control, control of flexible arms, and human factors.

  16. Computer code ARM1 for solving the inverse kinematics of a six-link manipulator arm

    International Nuclear Information System (INIS)

    ARM1 is a FORTRAN 77 program for the numerical solutions of the inverse kinematics problems. This paper is a detailed description of the current program (version 1). The code is simple enough for practical use and besides has no particular restrictions except for the specification of memory size. Incorporated checking statements or routine are useful in identifying the accuracies of solutions obtained. (author)

  17. 40 CFR 63.11621 - What are the standards for new and existing prepared feeds manufacturing facilities?

    Science.gov (United States)

    2010-07-01

    ... prepared feed products containing chromium or manganese are loaded into trucks or railcars, you must use a... between the loading arm and the truck or railcar. (e) For the pelleting operations at prepared feeds... manufacturer's specifications are not available, you must develop and follow standard maintenance and...

  18. Physical activity as an aid to smoking cessation during pregnancy (LEAP trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ussher Michael

    2012-10-01

    Full Text Available Abstract Background Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date. Methods/design The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy, and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations. The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome. Discussion This trial will assess whether a PA intervention is effective when used for

  19. a randomized, controlled trial

    OpenAIRE

    Reinecke, Franziska

    2010-01-01

    The polycystic ovarian syndrome (PCOS) is characterized by hyperandrogenism and associated with obesity and impaired glucose metabolism. Despite the high prevalence of PCOS and the considerable clinical impact, the precise interplay between metabolism and hyperandrogenemia is not entirely clear. To analyse the effects of intravenous lipid and heparin infusion on circulating androgen levels in healthy women, we performed a randomized controlled cross-over trial. 12 healthy young women durin...

  20. Randomised clinical trial

    DEFF Research Database (Denmark)

    Meineche-Schmidt, V.; Christensen, E.; Bytzer, P.

    2011-01-01

    Background: Response to proton pump inhibitor (PPI) treatment in dyspepsia is unpredictable. Aim: To identify symptoms associated with response to esomeprazole in order to target patients for empirical treatment. Methods: Eight hundred and five uninvestigated, primary care patients with upper GI ....... Conclusions In patients with uninvestigated dyspepsia, PPI responders can be reliably identified by a simple pocket chart using symptoms and patient characteristics (ClinicalTrials.gov NCT00318968). © 2010 Blackwell Publishing Ltd....

  1. Effectiveness of Electronic Reminders to Improve Medication Adherence in Tuberculosis Patients: A Cluster-Randomised Trial.

    Directory of Open Access Journals (Sweden)

    Xiaoqiu Liu

    2015-09-01

    Full Text Available Mobile text messaging and medication monitors (medication monitor boxes have the potential to improve adherence to tuberculosis (TB treatment and reduce the need for directly observed treatment (DOT, but to our knowledge they have not been properly evaluated in TB patients. We assessed the effectiveness of text messaging and medication monitors to improve medication adherence in TB patients.In a pragmatic cluster-randomised trial, 36 districts/counties (each with at least 300 active pulmonary TB patients registered in 2009 within the provinces of Heilongjiang, Jiangsu, Hunan, and Chongqing, China, were randomised using stratification and restriction to one of four case-management approaches in which patients received reminders via text messages, a medication monitor, combined, or neither (control. Patients in the intervention arms received reminders to take their drugs and reminders for monthly follow-up visits, and the managing doctor was recommended to switch patients with adherence problems to more intensive management or DOT. In all arms, patients took medications out of a medication monitor box, which recorded when the box was opened, but the box gave reminders only in the medication monitor and combined arms. Patients were followed up for 6 mo. The primary endpoint was the percentage of patient-months on TB treatment where at least 20% of doses were missed as measured by pill count and failure to open the medication monitor box. Secondary endpoints included additional adherence and standard treatment outcome measures. Interventions were not masked to study staff and patients. From 1 June 2011 to 7 March 2012, 4,292 new pulmonary TB patients were enrolled across the 36 clusters. A total of 119 patients (by arm: 33 control, 33 text messaging, 23 medication monitor, 30 combined withdrew from the study in the first month because they were reassessed as not having TB by their managing doctor (61 patients or were switched to a different

  2. Ad-hoc Network Based on ARM-Linux%基于ARM-Linux的Ad-hoc组网

    Institute of Scientific and Technical Information of China (English)

    王晓华; 贾继洋

    2014-01-01

    Aiming to solve the problem of the contemporary communication system in the absence of any network, a new scheme of the Ad-hoc network based on ARM-Linux system is designed. Firstly, this paper introduces the transportation of the Linux2.6.36 and the driver of RT3070 on ARM11 platform. Then based on socket programming in TCP/IP, program designing of communication and tests are conducted on the ARM-Linux platform. Results have proved that the Ad-hoc network can use the least resources and costs to achieve reliable high rate communication. It is significant for practical application.%针对传统通信系统不能满足在无任何网络情况下的通信需求现状,设计并实现了一种由 ARM-Linux 系统及其外围部件组成的无线自组网(Ad-hoc)的通信方案.在 ARM11平台上完成了 Linux2.6.36操作系统和RT3070无线通信模块的驱动程序移植.利用基于TCP/IP协议的socket编程,编写测试程序,进行节点间无线通信传输实验.实验结果表明:本文搭建的Ad-hoc网络,可以用最少的资源和成本,实现节点间可靠的无线高速率通信,具有现实应用意义.

  3. NATO SOCMET trials

    Science.gov (United States)

    Jenden, C. M.

    1993-11-01

    During 1993, Canada, France, Germany and the United Kingdom will be participating in the Smoke and Obscurants Countermeasures Materials Evaluation Tests (SOCMET). The tests will be carried out under the auspices of the NATO Army Armaments Group, AC/225, Panel VI, Sub-Panel 7 whose interests include multispectral smoke screening systems. The tests will comprise two sets of trials; one under cold climate conditions in Quebec, Canada, during February/March 1993 and the other in temperate conditions in Bourges, France during September 1993. This paper provides an insight into the management and aims of SOCMET. The evaluations will be seeking to identify candidate materials which create effective obscurant screens in the visible, infrared and millimetric bands of the electromagnetic spectrum. These materials will be disseminated through a range area dispersal. A key element of the trials will be the evaluation of field test instrumentation which may eventually lead to the development of standardized evaluation techniques. Following the trials, a scientific workshop will be held to review the results. A final report will be presented to NATO which will form the basis of future collaborative developments on multispectral screening systems leading towards standard NATO documentation on smoke and obscurant systems.

  4. Addressing the expected survival benefit for clinical trial design in metastatic castration-resistant prostate cancer: Sensitivity analysis of randomized trials.

    Science.gov (United States)

    Massari, Francesco; Modena, Alessandra; Ciccarese, Chiara; Pilotto, Sara; Maines, Francesca; Bracarda, Sergio; Sperduti, Isabella; Giannarelli, Diana; Carlini, Paolo; Santini, Daniele; Tortora, Giampaolo; Porta, Camillo; Bria, Emilio

    2016-02-01

    We performed a sensitivity analysis, cumulating all randomized clinical trials (RCTs) in which patients with metastatic castration-resistant prostate cancer (mCRPC) received systemic therapy, to evaluate if the comparison of RCTs may drive to biased survival estimations. An overall survival (OS) significant difference according to therapeutic strategy was more likely be determined in RCTs evaluating hormonal drugs versus those studies testing immunotherapy, chemotherapy or other strategies. With regard to control arm, an OS significant effect was found for placebo-controlled trials versus studies comparing experimental treatment with active therapies. Finally, regarding to docetaxel (DOC) timing, the OS benefit was more likely to be proved in Post-DOC setting in comparison with DOC and Pre-DOC. These data suggest that clinical trial design should take into account new benchmarks such as the type of treatment strategy, the choice of the comparator and the phase of the disease in relation to the administration of standard chemotherapy.

  5. Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial

    OpenAIRE

    Platt, Jennica; Baxter, Nancy; Jones, Jennifer; Metcalfe, Kelly; Causarano, Natalie; Hofer, Stefan OP; ONeill, Anne; Cheng, Terry; Starenkyj, Elizabeth; Zhong, Toni

    2013-01-01

    Background The Pre-Consultation Educational Group Intervention pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients. Methods/design This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design. Setting: The University Health Netw...

  6. Europe, arms control and American security

    International Nuclear Information System (INIS)

    What has come to be called the Revolution of 1989 has swept away longstanding political and economic arrangements in Eastern Europe. Perhaps more important, it has also called into question the fundamental underpinnings of European security created during the nonpeace that followed World War II. In June 1990, the Warsaw Treaty Organization abandoned the notion that NATO was the ideological enemy. At the same time, NATO ministers agreed at Tunberry, Scotland, to consider defining the Atlantic Alliance as more of a partner of the Soviet Union than as an enemy. The Washington summit of May 1990 between president Mikhail Gorbachev and president George Bush further highlighted the recent changes in the Soviet Union and its former satellites. Issues going to the heart of the viability of the Soviet Union and the communist system of political and economic organization competed with German reunification as central themes. Arms control issues, particularly as they pertain in European military stability, became contingent and dependent on the development of a broader political and economic framework for a new Europe. Whether this framework is viable remains an open question as Gorbachev's role is challenged more and more within the Soviet Union. This paper deals with European arms control issues from the point of view of the United States and its own security interests. The United States involved its security inextricably with that of Western Europe as a conscious decision in the turmoil following World War II

  7. ARM Climate Research Facility Annual Report 2004

    Energy Technology Data Exchange (ETDEWEB)

    Voyles, J.

    2004-12-31

    Like a rock that slowly wears away beneath the pressure of a waterfall, planet earth?s climate is almost imperceptibly changing. Glaciers are getting smaller, droughts are lasting longer, and extreme weather events like fires, floods, and tornadoes are occurring with greater frequency. Why? Part of the answer is clouds and the amount of solar radiation they reflect or absorb. These two factors clouds and radiative transfer represent the greatest source of error and uncertainty in the current generation of general circulation models used for climate research and simulation. The U.S. Global Change Research Act of 1990 established an interagency program within the Executive Office of the President to coordinate U.S. agency-sponsored scientific research designed to monitor, understand, and predict changes in the global environment. To address the need for new research on clouds and radiation, the U.S. Department of Energy (DOE) established the Atmospheric Radiation Measurement (ARM) Program. As part of the DOE?s overall Climate Change Science Program, a primary objective of the ARM Program is improved scientific understanding of the fundamental physics related to interactions between clouds and radiative feedback processes in the atmosphere.

  8. Characterizing Truthful Multi-Armed Bandit Mechanisms

    CERN Document Server

    Babaioff, Moshe; Slivkins, Aleksandrs

    2008-01-01

    We consider a multi-round auction setting motivated by pay-per-click auctions for Internet advertising. In each round the auctioneer selects an advertiser and shows her ad, which is then either clicked or not. An advertiser derives value from clicks; the value of a click is her private information. Initially, neither the auctioneer nor the advertisers have any information about the likelihood of clicks on the advertisements. The auctioneer's goal is to design a (dominant strategies) truthful mechanism that (approximately) maximizes the social welfare. If the advertisers bid their true private values, our problem is equivalent to the "multi-armed bandit problem", and thus can be viewed as a strategic version of the latter. In particular, for both problems the quality of an algorithm can be characterized by "regret", the difference in social welfare between the algorithm and the benchmark which always selects the same "best" advertisement. We investigate how the design of multi-armed bandit algorithms is affect...

  9. ARM 7 BASED MP3 PLAYER

    Directory of Open Access Journals (Sweden)

    Ashiq V Mehta

    2014-02-01

    Full Text Available MP3 is a patented encoding format for digital audio which uses a form of lossy data compression. It is a common audio format for consumer audio streaming or storage, as well as a de facto standard of digital audio compression for the transfer and playback of music on most digital audio players. Since the MPEG-1 Layer III encoding technology is nowadays widely used it might be interesting to gain knowledge of how this powerful compression/decompression scheme actually functions. The MPEG-1 Layer III is capable of reducing the bit rate with a factor of 12 without almost any audible degradation. Arm7 lpc2148 is arm7tdmi-s core board microcontroller that uses 16/32-bit 64 pin (lqfp microcontroller no.lpc2148 from Philips (nxp.The hardware system of lpc2148 includes the necessary devices within only one mcu has such as usb, adc, dac, timer/counter, pwm, capture, i2c, spi, uart, and etc.

  10. Structured Molecular Gas Reveals Galactic Spiral Arms

    CERN Document Server

    Sawada, Tsuyoshi; Koda, Jin

    2012-01-01

    We explore the development of structures in molecular gas in the Milky Way by applying the analysis of the brightness distribution function (BDF) 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 formati...

  11. Boundary Layer Cloudiness Parameterizations Using ARM Observations

    Energy Technology Data Exchange (ETDEWEB)

    Bruce Albrecht

    2004-09-15

    This study used DOE ARM data and facilities to: (1) study macroscopic properties of continental stratus clouds at SGP and the factors controlling these properties, (2) develop a scientific basis for understanding the processes responsible for the formation of boundary layer clouds using ARM observations in conjunction with simple parametric models and LES, and (3) evaluate cumulus cloud characteristics retrieved from the MMCR operating at TWP-Nauru. In addition we have used high resolution 94 GHz observations of boundary layer clouds and precipitation to: (1) develop techniques for using high temporal resolution Doppler velocities to study large-eddy circulations and turbulence in boundary layer clouds and estimate the limitations of using current and past MMCR data for boundary layer cloud studies, (2) evaluate the capability and limitations of the current MMCR data for estimating reflectivity, vertical velocities, and spectral under low- signal-to-noise conditions associated with weak no n-precipitating clouds, (3) develop possible sampling modes for the new MMCR processors to allow for adequate sampling of boundary layer clouds, and (4) retrieve updraft and downdraft structures under precipitating conditions.

  12. Why START. [Strategic Arms Reduction Talks treaty

    Energy Technology Data Exchange (ETDEWEB)

    Mendelsohn, J.

    1991-04-01

    Barring some major unexpected downturn in US-Soviet relations, it seems likely that the long-awaited Strategic Arms Reduction Talks (START) treaty will be signed sometime in 1991. Under negotiation for the past nine years, public acceptance and Senate approval of a START treaty will be facilitated by the generally less confrontational East-West relationship which has evolved over that time, by the growing constraints on the US defense budget, and by the obvious merits of the treaty itself. Not only will the nearly complete START treaty be an extremely useful and powerful arms control agreement, it is also decidedly advantageous to US security interests. First and foremost, a START treaty will cap and reduce the steady buildup of nuclear weapons that has characterized the last 30 years of the US-Soviet strategic relationship. As a result of the basic outline originally agreed to at the Reykjavik summit, START will take a 25 to 35 percent bite out of existing nuclear arsenals, impose approximately a 50 percent cut in overall Soviet ballistic missile warheads and throw-weight (lifting power or payload capacity), and produce an exact 50 percent cut in Soviet SS-18 missiles.

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

    International Nuclear Information System (INIS)

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

  14. Locoregionally advanced carcinoma of the oropharynx: conventional radiotherapy vs. accelerated hyperfractionated radiotherapy vs. concomitant radiotherapy and chemotherapy - a multicenter randomized trial

    International Nuclear Information System (INIS)

    Purpose: To compare conventional fractionation radiation therapy (RT), Arm A, vs. split-course accelerated hyperfractionated RT (S-AHF), Arm B, vs. conventional fractionation RT plus concomitant chemotherapy (CT), Arm C, in terms of survival and toxicity for advanced, unresectable epidermoid tumors of oropharynx. Methods and Materials: Between January 1993 and June 1998, 192 previously untreated patients affected with Stage III and IV oropharyngeal carcinoma (excluding T1N1 and T2N1) were accrued in a multicenter, randomized Phase III trial (ORO 93-01). For Arms A and C, 66-70 Gy in 33-35 fractions, 5 days a week, were administered in 6.5-7 weeks to tumor and positive nodes. In Arm B, the dose delivered to tumor and involved nodes was 64-67.2 Gy, giving 2 fractions of 1.6 Gy every day with an interfraction interval of at least 4 h and preferably 6 h, 5 days a week. At 38.4 Gy, a 2-week split was planned; after the split, RT was resumed with the same modality. In Arm C, CT regimen consisted of carboplatin and 5-fluorouracil (CBDCA 75 mg/m2, Days 1-4; 5-FU 1,000 mg/m2 i.v. over 96 h, Days 1-4, recycling every 28 days (at 1st, 5th, and 9th week). Results: No statistically significant difference was detected in overall survival (p=0.129): 40% Arm A vs. 37% Arm B vs. 51% Arm C were alive at 24 months. Similarly, there was no statistically significant difference in terms of event-free survival (p=0.196): 20% for Arm A, 19% for Arm B, and 37% for Arm C were event free at 24 months. On the contrary, the 2-year disease-free survival was significantly different among the three arms (p = 0.022), with a superiority for Arm C. At 24 months, the proportion of patients without relapse was 42% for Arm C vs. 23% for Arm A and 20% for Arm B. Patients in Arm A less frequently developed G3+ acute mucositis than their counterparts in Arm B or C (14.7% vs. 40.3% vs. 44%). Regarding the CT-related acute toxicity, apart from 1 case of fatal nephrotoxicity, only hematologic G3+ (Grade 3 or

  15. Octopus-inspired multi-arm robotic swimming.

    Science.gov (United States)

    Sfakiotakis, M; Kazakidi, A; Tsakiris, D P

    2015-05-13

    The outstanding locomotor and manipulation characteristics of the octopus have recently inspired the development, by our group, of multi-functional robotic swimmers, featuring both manipulation and locomotion capabilities, which could be of significant engineering interest in underwater applications. During its little-studied arm-swimming behavior, as opposed to the better known jetting via the siphon, the animal appears to generate considerable propulsive thrust and rapid acceleration, predominantly employing movements of its arms. In this work, we capture the fundamental characteristics of the corresponding complex pattern of arm motion by a sculling profile, involving a fast power stroke and a slow recovery stroke. We investigate the propulsive capabilities of a multi-arm robotic system under various swimming gaits, namely patterns of arm coordination, which achieve the generation of forward, as well as backward, propulsion and turning. A lumped-element model of the robotic swimmer, which considers arm compliance and the interaction with the aquatic environment, was used to study the characteristics of these gaits, the effect of various kinematic parameters on propulsion, and the generation of complex trajectories. This investigation focuses on relatively high-stiffness arms. Experiments employing a compliant-body robotic prototype swimmer with eight compliant arms, all made of polyurethane, inside a water tank, successfully demonstrated this novel mode of underwater propulsion. Speeds of up to 0.26 body lengths per second (approximately 100 mm s(-1)), and propulsive forces of up to 3.5 N were achieved, with a non-dimensional cost of transport of 1.42 with all eight arms and of 0.9 with only two active arms. The experiments confirmed the computational results and verified the multi-arm maneuverability and simultaneous object grasping capability of such systems.

  16. The Depression in Visual Impairment Trial (DEPVIT: trial design and protocol

    Directory of Open Access Journals (Sweden)

    Margrain Tom H

    2012-07-01

    Full Text Available Abstract Background The prevalence of depression in people with a visual disability is high but screening for depression and referral for treatment is not yet an integral part of visual rehabilitation service provision. One reason for this may be that there is no good evidence about the effectiveness of treatments in this patient group. This study is the first to evaluate the effect of depression treatments on people with a visual impairment and co morbid depression. Methods /design The study is an exploratory, multicentre, individually randomised waiting list controlled trial. Participants will be randomised to receive Problem Solving Therapy (PST, a ‘referral to the GP’ requesting treatment according to the NICE’s ‘stepped care’ recommendations or the waiting list arm of the trial. The primary outcome measure is change (from randomisation in depressive symptoms as measured by the Beck’s Depression Inventory (BDI-II at 6 months. Secondary outcomes include change in depressive symptoms at 3 months, change in visual function as measured with the near vision subscale of the VFQ-48 and 7 item NEI-VFQ at 3 and 6 months, change in generic health related quality of life (EQ5D, the costs associated with PST, estimates of incremental cost effectiveness, and recruitment rate estimation. Discussion Depression is prevalent in people with disabling visual impairment. This exploratory study will establish depression screening and referral for treatment in visual rehabilitation clinics in the UK. It will be the first to explore the efficacy of PST and the effectiveness of NICE’s ‘stepped care’ approach to the treatment of depression in people with a visual impairment. Trial registration ISRCTN46824140

  17. “Smart” RCTs: Development of a Smartphone App for Fully Automated Nutrition-Labeling Intervention Trials

    Science.gov (United States)

    Li, Nicole; Dunford, Elizabeth; Eyles, Helen; Crino, Michelle; Michie, Jo; Ni Mhurchu, Cliona

    2016-01-01

    Background There is substantial interest in the effects of nutrition labels on consumer food-purchasing behavior. However, conducting randomized controlled trials on the impact of nutrition labels in the real world presents a significant challenge. Objective The Food Label Trial (FLT) smartphone app was developed to enable conducting fully automated trials, delivering intervention remotely, and collecting individual-level data on food purchases for two nutrition-labeling randomized controlled trials (RCTs) in New Zealand and Australia. Methods Two versions of the smartphone app were developed: one for a 5-arm trial (Australian) and the other for a 3-arm trial (New Zealand). The RCT protocols guided requirements for app functionality, that is, obtaining informed consent, two-stage eligibility check, questionnaire administration, randomization, intervention delivery, and outcome assessment. Intervention delivery (nutrition labels) and outcome data collection (individual shopping data) used the smartphone camera technology, where a barcode scanner was used to identify a packaged food and link it with its corresponding match in a food composition database. Scanned products were either recorded in an electronic list (data collection mode) or allocated a nutrition label on screen if matched successfully with an existing product in the database (intervention delivery mode). All recorded data were transmitted to the RCT database hosted on a server. Results In total approximately 4000 users have downloaded the FLT app to date; 606 (Australia) and 1470 (New Zealand) users met the eligibility criteria and were randomized. Individual shopping data collected by participants currently comprise more than 96,000 (Australia) and 229,000 (New Zealand) packaged food and beverage products. Conclusions The FLT app is one of the first smartphone apps to enable conducting fully automated RCTs. Preliminary app usage statistics demonstrate large potential of such technology, both for

  18. Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial

    Directory of Open Access Journals (Sweden)

    Seo Byung-Kwan

    2013-01-01

    Full Text Available Abstract Background Chronic non-specific low back pain is the most common medical problem for which patients seek complementary and alternative medical treatment, including bee venom acupuncture. However, the effectiveness and safety of such treatments have not been fully established by randomized clinical trials. The aim of this study is to determine whether bee venom acupuncture is effective for improving pain intensity, functional status and quality of life of patients with chronic non-specific low back pain. Methods/design This study is a randomized, double-blinded, sham-controlled clinical trial with two parallel arms. Fifty-four patients between 18 and 65 years of age with non-radicular chronic low back pain experiencing low back pain lasting for at least the previous three months and ≥4 points on a 10-cm visual analog scale for bothersomeness at the time of screening will be included in the study. Participants will be randomly allocated into the real or sham bee venom acupuncture groups and treated by the same protocol to minimize non-specific and placebo effects. Patients, assessors, acupuncturists and researchers who prepare the real or sham bee venom acupuncture experiments will be blinded to group allocation. All procedures, including the bee venom acupuncture increment protocol administered into predefined acupoints, are designed by a process of consensus with experts and previous researchers according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture. Bothersomeness measured using a visual analogue scale will be the primary outcome. Back pain-related dysfunction, pain, quality of life, depressive symptoms and adverse experiences will be measured using the visual analogue scale for pain intensity, the Oswestry Disability Index, the EuroQol 5-Dimension, and the Beck’s Depression Inventory. These measures will be recorded at baseline and 1, 2, 3, 4, 8 and 12 weeks. Discussion The results from this study

  19. Clinical Trials and Treatment of ATL

    Directory of Open Access Journals (Sweden)

    Kunihiro Tsukasaki

    2012-01-01

    Full Text Available ATL is a distinct peripheral T-lymphocytic malignancy associated with human T-cell lymphotropic virus type I (HTLV-1. The diversity in clinical features and prognosis of patients with this disease has led to its subtype-classification into four categories, acute, lymphoma, chronic, and smoldering types, defined by organ involvement, and LDH and calcium values. In case of acute, lymphoma, or unfavorable chronic subtypes (aggressive ATL, intensive chemotherapy like the LSG15 regimen (VCAP-AMP-VECP is usually recommended if outside of clinical trials, based on the results of a phase 3 trial. In case of favorable chronic or smoldering ATL (indolent ATL, watchful waiting until disease progression has been recommended, although the long-term prognosis was inferior to those of, for instance, chronic lymphoid leukemia. Retrospective analysis suggested that the combination of interferon alpha and zidovudine was apparently promising for the treatment of ATL, especially for types with leukemic manifestation. Allogeneic hematopoietic stem cell transplantation (allo-HSCT is also promising for the treatment of aggressive ATL possibly reflecting graft versus ATL effect. Several new agent trials for ATL are ongoing and in preparation, including a defucosylated humanized anti-CC chemokine receptor 4 monoclonal antibody, IL2-fused with diphtheria toxin, histone deacetylase inhibitors, a purine nucleoside phosphorylase inhibitor, a proteasome inhibitor, and lenalidomide.

  20. Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial

    Science.gov (United States)

    Aga, Anna-Birgitte; Olsen, Inge Christoffer; Lillegraven, Siri; Hammer, Hilde B; Uhlig, Till; Fremstad, Hallvard; Madland, Tor Magne; Lexberg, Åse Stavland; Haukeland, Hilde; Rødevand, Erik; Høili, Christian; Stray, Hilde; Noraas, Anne; Hansen, Inger Johanne Widding; Bakland, Gunnstein; Nordberg, Lena Bugge; van der Heijde, Désirée; Kvien, Tore K

    2016-01-01

    Objective To determine whether a treatment strategy based on structured ultrasound assessment would lead to improved outcomes in rheumatoid arthritis, compared with a conventional strategy. Design Multicentre, open label, two arm, parallel group, randomised controlled strategy trial. Setting Ten rheumatology departments and one specialist centre in Norway, from September 2010 to September 2015. Participants 238 patients were recruited between September 2010 and April 2013, of which 230 (141 (61%) female) received the allocated intervention and were analysed for the primary outcome. The main inclusion criteria were age 18-75 years, fulfilment of the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis, disease modifying anti-rheumatic drug naivety with indication for disease modifying drug therapy, and time from first patient reported swollen joint less than two years. Patients with abnormal kidney or liver function or major comorbidities were excluded. Interventions 122 patients were randomised to an ultrasound tight control strategy targeting clinical and imaging remission, and 116 patients were randomised to a conventional tight control strategy targeting clinical remission. Patients in both arms were treated according to the same disease modifying anti-rheumatic drug escalation strategy, with 13 visits over two years. Main outcome measures The primary endpoint was the proportion of patients with a combination between 16 and 24 months of clinical remission, no swollen joints, and non-progression of radiographic joint damage. Secondary outcomes included measures of disease activity, radiographic progression, functioning, quality of life, and adverse events. All participants who attended at least one follow-up visit were included in the full analysis set. Results 26 (22%) of the 118 analysed patients in the ultrasound tight control arm and 21 (19%) of the 112 analysed patients in the