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Sample records for included trials closed

  1. Molecular-state close-coupling theory including continuum states. I. Derivation of close-coupled equations

    International Nuclear Information System (INIS)

    Thorson, W.R.; Bandarage, G.

    1988-01-01

    We formulate a close-coupling theory of slow ion-atom collisions based on molecular (adiabatic) electronic states, and including the electronic continuum. The continuum is represented by packet states spanning it locally and constructed explicitly from exact continuum states. Particular attention is given to two fundamental questions: (1) Unbound electrons can escape from the local region spanned by the packet states. We derive close-coupled integral equations correctly including the escape effects; the ''propagator'' generated by these integral equations does not conserve probability within the close-coupled basis. Previous molecular-state formulations including the continuum give no account of escape effects. (2) Nonadiabatic couplings of adiabatic continuum states with the same energy are singular, reflecting the fact that an adiabatic description of continuum behavior is not valid outside a local region. We treat these singularities explicitly and show that an accurate representation of nonadiabatic couplings within the local region spanned by a set of packet states is well behaved. Hence an adiabatic basis-set description can be used to describe close coupling to the continuum in a local ''interaction region,'' provided the effects of escape are included. In principle, the formulation developed here can be extended to a large class of model problems involving many-electron systems and including models for Penning ionization and collisional detachment processes

  2. Assessing bias in osteoarthritis trials included in Cochrane reviews

    DEFF Research Database (Denmark)

    Hansen, Julie Bolvig; Juhl, Carsten Bogh; Boutron, Isabelle

    2014-01-01

    the first appearing forest plot for overall pain in the Cochrane review. Treatment effect sizes will be expressed as standardised mean differences (SMDs), where the difference in mean values available from the forest plots is divided by the pooled SD. To empirically assess the risk of bias in treatment......INTRODUCTION: The validity of systematic reviews and meta-analysis depends on methodological quality and unbiased dissemination of trials. Our objective is to evaluate the association of estimates of treatment effects with different bias-related study characteristics in meta...... benefits, we will perform stratified analyses of the trials from the included meta-analyses and assess the interaction between trial characteristics and treatment effect. A relevant study-level covariate is defined as one that decreases the between-study variance (τ(2), estimated as Tau...

  3. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

    International Nuclear Information System (INIS)

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M.; Lössl, Kristina

    2016-01-01

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users

  4. Closed-form solutions for linear regulator design of mechanical systems including optimal weighting matrix selection

    Science.gov (United States)

    Hanks, Brantley R.; Skelton, Robert E.

    1991-01-01

    Vibration in modern structural and mechanical systems can be reduced in amplitude by increasing stiffness, redistributing stiffness and mass, and/or adding damping if design techniques are available to do so. Linear Quadratic Regulator (LQR) theory in modern multivariable control design, attacks the general dissipative elastic system design problem in a global formulation. The optimal design, however, allows electronic connections and phase relations which are not physically practical or possible in passive structural-mechanical devices. The restriction of LQR solutions (to the Algebraic Riccati Equation) to design spaces which can be implemented as passive structural members and/or dampers is addressed. A general closed-form solution to the optimal free-decay control problem is presented which is tailored for structural-mechanical system. The solution includes, as subsets, special cases such as the Rayleigh Dissipation Function and total energy. Weighting matrix selection is a constrained choice among several parameters to obtain desired physical relationships. The closed-form solution is also applicable to active control design for systems where perfect, collocated actuator-sensor pairs exist.

  5. Lab-scale experiment of a closed thermochemical heat storage system including honeycomb heat exchanger

    International Nuclear Information System (INIS)

    Fopah-Lele, Armand; Rohde, Christian; Neumann, Karsten; Tietjen, Theo; Rönnebeck, Thomas; N'Tsoukpoe, Kokouvi Edem; Osterland, Thomas; Opel, Oliver

    2016-01-01

    A lab-scale thermochemical heat storage reactor was developed in the European project “thermal battery” to obtain information on the characteristics of a closed heat storage system, based on thermochemical reactions. The present type of storage is capable of re-using waste heat from cogeneration system to produce useful heat for space heating. The storage material used was SrBr 2 ·6H 2 O. Due to agglomeration or gel-like problems, a structural element was introduced to enhance vapour and heat transfer. Honeycomb heat exchanger was designed and tested. 13 dehydration-hydration cycles were studied under low-temperature conditions (material temperatures < 100 °C) for storage. Discharging was realized at water vapour pressure of about 42 mbar. Temperature evolution inside the reactor at different times and positions, chemical conversion, thermal power and overall efficiency were analysed for the selected cycles. Experimental system thermal capacity and efficiency of 65 kWh and 0.77 are respectively obtained with about 1 kg of SrBr 2 ·6H 2 O. Heat transfer fluid recovers heat at a short span of about 43 °C with an average of 22 °C during about 4 h, acceptable temperature for the human comfort (20 °C on day and 16 °C at night). System performances were obtained for a salt bed energy density of 213 kWh·m 3 . The overall heat transfer coefficient of the honeycomb heat exchanger has an average value of 147 W m −2  K −1 . Though promising results have been obtained, ameliorations need to be made, in order to make the closed thermochemical heat storage system competitive for space heating. - Highlights: • Lab-scale thermochemical heat storage is designed, constructed and tested. • The use of honeycomb heat exchanger as a heat and vapour process enhancement. • Closed system (1 kg SrBr 2 ·6H 2 O) able to give back 3/4 of initial thermal waste energy. • System storage capacity and thermal efficiency are respectively 65 kWh and 0.77.

  6. Sensor Life and Overnight Closed Loop: A Randomized Clinical Trial.

    Science.gov (United States)

    Tauschmann, Martin; Allen, Janet M; Wilinska, Malgorzata E; Ruan, Yue; Thabit, Hood; Acerini, Carlo L; Dunger, David B; Hovorka, Roman

    2017-05-01

    Closed-loop (CL) systems direct insulin delivery based on continuous glucose monitor (CGM) sensor values. CGM accuracy varies with sensor life, being least accurate on day 1 of sensor insertion. We evaluated the effect of sensor life (enhanced Enlite, Medtronic MiniMed, Northridge, CA) on overnight CL. In an open-label, randomized, 2-period, inpatient crossover pilot study, 12 adolescents on insulin pump (age 16.7 ± 1.9 years; HbA1c 66 ± 10 mmol/mol) attended a clinical research facility on 2 overnight occasions. In random order, participants received CL on day 1 or on day 3-4 after sensor insertion. During both periods, glucose was automatically controlled by a model predictive control algorithm informed by sensor glucose. Plasma glucose was measured every 30 to 60 min. During overnight CL (22:30 to 07:30), the proportion of time with plasma glucose readings in the target range (3.9-8.0 mmol/l, primary endpoint) when initiated on day 1 of sensor insertion vs day 3-4 were comparable (58 ± 32% day 1 vs 56 ± 36% day 3-4; P = .34), and there were no significant differences between interventions in terms of mean plasma glucose ( P = .26), percentage time above 8.0 mmol/l ( P = .49), and time spent below 3.9 mmol/l ( P = .93). Sensor accuracy varied with sensor life (mean absolute relative difference 19.8 ± 15.0% on day 1 and 13.7 ± 10.2% on day 3 to 4). Sensor glucose tended to under-read plasma glucose inflating benefits of CL on glucose control. In spite of differences in sensor accuracy, overnight CL glucose control informed by sensor glucose on day 1 or day 3-4 after sensor insertion was comparable. The model predictive controller appears to mitigate against sensor inaccuracies.

  7. The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials.

    Science.gov (United States)

    Welch, Mary Jane; Lally, Rachel; Miller, Jennifer E; Pittman, Stephanie; Brodsky, Lynda; Caplan, Arthur L; Uhlenbrauck, Gina; Louzao, Darcy M; Fischer, James H; Wilfond, Benjamin

    2015-10-01

    Policies have been developed to protect vulnerable populations in clinical research, including the US federal research regulations (45 Code of Federal Regulations 46 Subparts B, C, and D). These policies generally recognize vulnerable populations to include pregnant women, fetuses, neonates, children, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons. The aim has been to protect these populations from harm, often by creating regulatory and ethical checks that may limit their participation in many clinical trials. The recent increase in pragmatic clinical trials raises at least two questions about this approach. First, is exclusion itself a harm to vulnerable populations, as these groups may be denied access to understanding how health interventions work for them in clinical settings? Second, are groups considered vulnerable in traditional clinical trials also vulnerable in pragmatic clinical trials? We argue first that excluding vulnerable subjects from participation in pragmatic clinical trials can be harmful by preventing acquisition of data to meaningfully inform clinical decision-making in the future. Second, we argue that protections for vulnerable subjects in traditional clinical trial settings may not be translatable, feasible, or even ethical to apply in pragmatic clinical trials. We conclude by offering specific recommendations for appropriately protecting vulnerable research subjects in pragmatic clinical trials, focusing on pregnant women, fetuses, neonates, children, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons. © The Author(s) 2015.

  8. Conservative management or closed nailing for tibial shaft fractures. A randomised prospective trial.

    Science.gov (United States)

    Hooper, G J; Keddell, R G; Penny, I D

    1991-01-01

    We performed a prospective randomised trial on matched groups of patients with displaced tibial shaft fractures to compare conservative treatment with closed intramedullary nailing. The results showed conclusively that intramedullary nailing gave more rapid union with less malunion and shortening. Nailed patients had less time off work with a more predictable and rapid return to full function. We therefore consider that closed intramedullary nailing is the most efficient treatment for displaced fractures of the tibial shaft.

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

    Science.gov (United States)

    Stamenovic, Milorad; Dobraca, Amra; Smajlovic, Mersiha

    2018-01-01

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

  10. Enhancing Efficiency of Safeguards at Facilities that are Shutdown or Closed-Down, including those being Decommissioned

    Energy Technology Data Exchange (ETDEWEB)

    Moran, B. [Brookhaven National Lab. (BNL), Upton, NY (United States); Stern, W. [Brookhaven National Lab. (BNL), Upton, NY (United States); Colley, J. [Brookhaven National Lab. (BNL), Upton, NY (United States); Marzo, M. [Brookhaven National Lab. (BNL), Upton, NY (United States)

    2016-12-15

    International Atomic Energy Agency (IAEA) safeguards involves verification activities at a wide range of facilities in a variety of operational phases (e.g., under construction, start-up, operating, shutdown, closed-down, and decommissioned). Safeguards optimization for each different facility type and operational phase is essential for the effectiveness of safeguards implementation. The IAEA’s current guidance regarding safeguards for the different facility types in the various lifecycle phases is provided in its Design Information Examination (DIE) and Verification (DIV) procedure. 1 Greater efficiency in safeguarding facilities that are shut down or closed down, including those being decommissioned, could allow the IAEA to use a greater portion of its effort to conduct other verification activities. Consequently, the National Nuclear Security Administration’s Office of International Nuclear Safeguards sponsored this study to evaluate whether there is an opportunity to optimize safeguards approaches for facilities that are shutdown or closed-down. The purpose of this paper is to examine existing safeguards approaches for shutdown and closed-down facilities, including facilities being decommissioned, and to seek to identify whether they may be optimized.

  11. The manufacturing method of pyrographite tubing including those closed from one side and equipment for manufacturing of pyrographite tubing

    International Nuclear Information System (INIS)

    Wlodarski, R.; Nowicki, A.; Pekalska, L.; Szczepankiewicz, C.; Kuznicki, R.; Tulik, J.; Kaczmarek, B.

    1992-01-01

    The method as well as equipment for manufacturing of pyrographite tubing including those closed from one side has been worked out. The method consists in pyrolysis of aliphatic and aromatic hydrocarbons or their mixtures. The process runs under diminished pressure in the temperature range of 1700-2600 K. The layering of graphite is organized on graphite bars having big thermal expansion coefficient. The manufacturing equipment is installed inside an electric furnace. Construction details are described in the patent. 1 fig

  12. Reamed and unreamed intramedullary nailing for the treatment of open and closed tibial fractures: a subgroup analysis of randomised trials

    Science.gov (United States)

    Xue, Deting; Zheng, Qiang; Li, Hang; Qian, Shengjun; Zhang, Bo

    2009-01-01

    The choice between reamed and unreamed intramedullary nailing for the treatment of open and closed tibial fractures is an ongoing controversy. We carried out a comprehensive search strategy. Six eligible randomised controlled trials were included. Three reviewers independently assessed methodological quality and extracted outcome data. Analyses were performed using Review Manager 5.0. The results showed lower risks of tibial fracture nonunion and implant failures with reamed nails compared to unreamed nails in closed tibial fractures [relative risk (RR): 0.41, 95% confidence interval (CI): 0.21–0.89, P = 0.008 for nonunion and RR: 0.35, 95% CI: 0.22–0.56, P reamed and unreamed nails in open tibial fractures. In conclusion, our study recommended reamed nails for the treatment of closed tibial fractures. But the choice for open tibial fractures remains uncertain. PMID:19841919

  13. Closed-form solutions for linear regulator-design of mechanical systems including optimal weighting matrix selection

    Science.gov (United States)

    Hanks, Brantley R.; Skelton, Robert E.

    1991-01-01

    This paper addresses the restriction of Linear Quadratic Regulator (LQR) solutions to the algebraic Riccati Equation to design spaces which can be implemented as passive structural members and/or dampers. A general closed-form solution to the optimal free-decay control problem is presented which is tailored for structural-mechanical systems. The solution includes, as subsets, special cases such as the Rayleigh Dissipation Function and total energy. Weighting matrix selection is a constrained choice among several parameters to obtain desired physical relationships. The closed-form solution is also applicable to active control design for systems where perfect, collocated actuator-sensor pairs exist. Some examples of simple spring mass systems are shown to illustrate key points.

  14. Staff experiences of closing out a clinical trial involving withdrawal of treatment: qualitative study.

    Science.gov (United States)

    Lawton, Julia; White, David; Rankin, David; Elliott, Jackie; Taylor, Carolin; Cooper, Cindy; Heller, Simon; Hallowell, Nina

    2017-02-07

    The ending of a clinical trial may be challenging, particularly if staff are required to withdraw the investigated treatment(s); however, this aspect of trial work is surprisingly under-researched. To address this gap, we explored the experiences of staff involved in closing out a trial that entailed withdrawal of treatment (insulin pumps) from some patients. Interviews were conducted with n = 22 staff, recruited from seven trial sites. Data were analysed thematically. Staff described a myriad of ethical and emotional challenges at closeout, many of which had been unforeseen when the trial began. A key challenge for staff was that, while patients gave their agreement to participate on the understanding that pump treatment could be withdrawn, they often found themselves benefitting from this regimen in ways they could not have foreseen. Hence, as the trial progressed, patients became increasingly anxious about withdrawal of treatment. This situation forced staff to consider whether the consent patients had given at the outset remained valid; it also presented them with a dilemma at closeout because many of those who had wanted to remain on a pump did not meet the clinical criteria required for post-trial funding. When deciding whether to withdraw treatment, staff not only had to take funding pressures and patient distress into account, but they also found themselves caught between an ethic of Hippocratic individualism and one of utilitarianism. These conflicting pressures and ethical considerations resulted in staff decision-making varying across the sites, an issue that some described as a further source of ethical unease. Staff concluded that, had there been more advanced planning and discussion, and greater accountability to an ethics committee, some of the challenges they had confronted at closeout could have been lessened or even prevented. The same kinds of ethical issues that may vex staff at the beginning of a trial (e.g. patients having unrealistic

  15. Identification of Drug Characteristics for Implementing Multiregional Clinical Trials Including Japan.

    Science.gov (United States)

    Rokuda, Mitsuhiro; Matsumaru, Naoki; Tsukamoto, Katsura

    2018-02-01

    Multiregional clinical trials (MRCT) are a standard strategy used to improve global drug approval efficiency and the feasibility of clinical trials. Japan is the world's third largest drug market with a unique health care system, making it a key inclusion as an operational region for MRCT (MRCT-JP) for global drug development. We aimed to identify the factors required for efficient drug development by comprehensively reviewing the clinical trials of drugs approved in Japan to identify the factors associated with whether or not MRCT-JP is implemented. We surveyed the review reports and summaries of application data published by the Pharmaceuticals and Medical Devices Agency. We identified drugs for which the clinical trial data package included MRCT-JP and selected the same number of drugs for which the clinical trial data package did not include MRCT-JP from the most recent survey period for comparison. We also examined other publication information, in addition to the review reports, as necessary. The influence of each explanatory variable was analyzed by logistic regression analysis, with whether or not MRCT-JP was implemented as the explanatory variable. Statistical significance was set at 5%. In the survey period up to September 2017, 165 drugs developed with MRCT-JP were approved for manufacture and sale in Japan. "Respiratory system," "inhalation," "biological drug," and "under review" evaluation status for the United States, European Union, and other areas, "approved" evaluation status for the United States, "new ingredients," "priority review," "non-Japanese firm," and "Top 1-10" and "Top 11-20" drug sales rankings for pharmaceutical companies were identified as potential factors leading to the implementation of MRCT-JP. In contrast, "general anti-infectives for systemic use," "various," "external," "chemical compound," "unsubmitted" evaluation status for both the United States and European Union, and "Top 51+" drug sales rankings were potential factors for

  16. A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis – trial intervention including physician and treatment characteristics

    OpenAIRE

    Ortiz, Miriam; Witt, Claudia M; Binting, Sylvia; Helmreich, Cornelia; Hummelsberger, Josef; Pfab, Florian; Wullinger, Michael; Irnich, Dominik; Linde, Klaus; Niggemann, Bodo; Willich, Stefan N; Brinkhaus, Benno

    2014-01-01

    Background In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial’s participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers a...

  17. Robustness assessments are needed to reduce bias in meta-analyses that include zero-event randomized trials

    DEFF Research Database (Denmark)

    Keus, F; Wetterslev, J; Gluud, C

    2009-01-01

    of statistical method on inference. RESULTS: In seven meta-analyses of seven outcomes from 15 trials, there were zero-event trials in 0 to 71.4% of the trials. We found inconsistency in significance in one of seven outcomes (14%; 95% confidence limit 0.4%-57.9%). There was also considerable variability...... in the confidence limits, the intervention-effect estimates, and heterogeneity for all outcomes. CONCLUSIONS: The statistical method may influence the inference drawn from a meta-analysis that includes zero-event trials. Robustness assessments are needed to reduce bias in meta-analyses that include zero......OBJECTIVES: Meta-analysis of randomized trials with binary data can use a variety of statistical methods. Zero-event trials may create analytic problems. We explored how different methods may impact inferences from meta-analyses containing zero-event trials. METHODS: Five levels of statistical...

  18. A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis--trial intervention including physician and treatment characteristics.

    Science.gov (United States)

    Ortiz, Miriam; Witt, Claudia M; Binting, Sylvia; Helmreich, Cornelia; Hummelsberger, Josef; Pfab, Florian; Wullinger, Michael; Irnich, Dominik; Linde, Klaus; Niggemann, Bodo; Willich, Stefan N; Brinkhaus, Benno

    2014-04-06

    In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial's participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers and physicians. ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) was a three-armed, randomised, controlled multicentre trial. 422 SAR patients were randomised to semi-standardised acupuncture plus rescue medication (RM, cetirizine), sham acupuncture plus RM or RM alone. We sent a questionnaire to trial physicians in order to evaluate their characteristics regarding their education about and experience in providing acupuncture. During the trial, acupuncturists were asked to diagnose all of their patients according to Chinese Medicine (CM) as a basis for the semi-standardised, individualized intervention in the acupuncture group. Every acupuncture point used in this trial had to be documented after each session Acupuncture was administered in outpatient clinics by 46 (mean age 47 ± 10 years; 24 female/ 22 male) conventionally-trained medical doctors (67% with postgraduate specialization such as internal or family medicine) with additional extensive acupuncture training (median 500 hours (1st quartile 350, 3rd quartile 1000 hours with 73% presenting a B-diploma in acupuncture training (350 hours)) and experience (mean 14 years in practice). The most reported traditional CM diagnosis was 'wind-cold invading the lung' (37%) and 'wind-heat invading the lung' (37%), followed by 'lung and spleen qi deficiency' (9%). The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group (15.7 ± 2.5 vs. 10.0 ± 1.6). The trial interventions were

  19. Post-trial sleep sequences including transition sleep are involved in avoidance learning of adult rats.

    Science.gov (United States)

    Mandile, P; Vescia, S; Montagnese, P; Piscopo, S; Cotugno, M; Giuditta, A

    2000-07-01

    High resolution computerized EEG analyses, and behavioral observations were used to identify slow wave sleep (SS), paradoxical sleep (PS) and transition sleep (TS) in adult male Wistar rats exposed to a session of two-way active avoidance training. Of the four sleep sequences that could be identified, two included TS (SS-->TS-->W and SS-->TS-->PS), while the other two did not (SS-->W and SS-->PS). Comparison of post-trial sleep variables between fast learning rats (FL, reaching criterion in the training session), slow learning rats (SL, reaching criterion in the retention session the following day), and non learning rats (NL, failing to reach criterion) indicated that the total amounts of SS, TS and PS of the SS-->TS-->PS sequence was markedly higher in FL rats than in SL rats. In addition, in comparison with the corresponding baseline period, the average duration and total amount of SS and TS episodes of the SS-->TS-->PS sequence increased in FL rats, while the number of SS-->TS-->W sequences decreased. On the other hand, the average duration of SS episodes increased in the SS-->TS-->W and SS-->W sequences of SL rats, and in the SS-->W and SS-->TS-->PS sequences of NL rats. Correlative analyses between number of avoidances and post-trial sleep variables demonstrated that avoidances were directly correlated with the duration of SS episodes of the SS-->TS-->PS sequence and with the duration of TS episodes of the SS-->TS-->W sequence, but inversely correlated with the number and amount of SS episodes of the SS-->W sequence and with the duration and amount of SS episodes of the SS-->PS sequence. On the whole, the data supported the view that TS-containing sleep sequences are involved in long-term storage of novel adaptive behavior, while sleep sequences lacking TS are involved in the maintenance of innate behavioral responses.

  20. Milligan-Morgan (Open) Versus Ferguson Haemorrhoidectomy (Closed): A Systematic Review and Meta-Analysis of Published Randomized, Controlled Trials.

    Science.gov (United States)

    Bhatti, Muhammad I; Sajid, Muhammad Shafique; Baig, Mirza K

    2016-06-01

    The purpose of this article is to systematically analyse the randomized, controlled trials (RCTs) comparing Ferguson or closed haemorrhoidectomy (CH) versus open haemorrhoidectomy (OH) or Milligan-Morgan haemorrhoidectomy in the management of haemorrhoidal disease (HD). RCTs on the effectiveness of CH and OH in the management of HD were analysed systematically using RevMan(®), and combined outcome was expressed as odds ratio (OR) and standardized mean difference. Eleven CRTs encompassing 1326 patients were analysed systematically. There was significant heterogeneity among included trials. Therefore, in the random effects model, CH was associated with a reduced post-operative pain (SMD, -0.36; 95 % CI, -0.64, -0.07; z = 2.45; p = 0.01), faster wound healing (OR, 0.08; 95 % CI, 0.02, 0.24; z = 4.33; p SMD, 6.10; 95 % CI, 3.21, 8.98; z = 4.13; p SMD, -0.33; 95 % CI, -0.68, 0.03; z = 1.82; p = 0.07), length of hospital stay, post-operative complications, HD recurrence and risk of surgical site infection were similar in both groups. CH has clinically measurable advantages over OH in terms of reduced post-operative pain, lower risk of post-operative bleeding and faster wound healing.

  1. Effect of closed drainage system on edema and ecchymosis following rhinoplasty: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Kamran Asadi

    2013-08-01

    Full Text Available Background: The aim of this study was to minimize edema and ecchymosis following rhinoplasty through a closed drainage system to address concealed hemorrhage.Methods: This study was designed as a prospective، double blinded, randomized contr-olled study. Fifty one patients who underwent septorhinoplasty were included in this study and divided in two groups. In group A, a closed drainage system was applied in the most dependent posterior septal area following septal harvesting. Concealed bloody secretions were drained out of mouth in a vacutaner tube during three concecutive post operative days. In control group, group B, exactly the same classic rhinoplasty opera-tion by the same surgeon was done as for study group except omitting the closed drainage system. Degree of supra-tip and eyelid edema was evaluated on post operative days through photographic and software image analysis. Edema and ecchymosis rating of eyelids and ecchymosis of paranasal and cheek area done based on photographic analysis by independent plastic surgeons using a defined grading system.Results: Eyelid ecchymosis was reduced significantly on post operative day 14 in the study group (P=0.03. Ecchymosis of paranasal and check was reduced considerably likewise on days 7 and 14 in group A using Mann-Whitney test (P=0.03. There was no significant deference regarding supra tip edema on post operative days. The same hold true for the eyelids edema.Conclusion: Significant decrement observed in eyelids ecchymosis on day 14 and para-nasal and cheek ecchymosis on postoperative days 7 and 14 in study group. There were no positive effects regarding supra tip and eyelid edema reduction using closed drainage system to evacuate concealed haemorrhage in posterior septum space. There could be different etio-pathologies for two common morbidities following rhinoplasty that should be addressed separately.

  2. Do we have to Include HCI Issues in Clinical Trials of Medical Devices?

    DEFF Research Database (Denmark)

    Nielsen, Lene; Christensen, Lars Rune; Sabers, Anne

    2017-01-01

    Digital devices play an important role in medical treatment and will in the future play a larger role in connection to cures of health-related issues. Traditionally medicine has been tested by clinical double blind, randomized trials to document the efficacy and safety profile. When it comes...... to the use of digital devices in treatments the protocols from the field of medicine is adopted. The question is whether or not this evidence based approach is useful when dealing with digital devices and whether the understanding of the efficiency of a treatment can be obtained without also looking...... at usability and lifestyle issues. Based on a case study of epilepsy, a literature study of protocols for investigating treatments using digital medical devices, the set-up of studies, the design of a current protocol for clinical trials, and finally preliminary results, we discuss if clinical trials have...

  3. Estimation of hull girder vertical bending moments including non-linear and flexibility effects using closed form expressions

    DEFF Research Database (Denmark)

    Pedersen, Preben Terndrup; Jensen, Jørgen Juncher

    2009-01-01

    -induced loads are evaluated for specific operational profiles. Non-linearity in the wave bending moment is modeled using results derived from a second-order strip theory and water entry solutions for wedge type sections. Hence, bow flare slamming is accounted for through a momentum type of approach....... The stochastic properties of this non-linear response are calculated through a monotonic Hermite transformation. In addition, the impulse loading due to e.g. bottom slamming or a rapid change in bow flare is included using a modal expansion in the two lowest vertical vibration modes. These whipping vibrations...

  4. Time to consider sharing data extracted from trials included in systematic reviews

    Directory of Open Access Journals (Sweden)

    Luke Wolfenden

    2016-11-01

    Full Text Available Abstract Background While the debate regarding shared clinical trial data has shifted from whether such data should be shared to how this is best achieved, the sharing of data collected as part of systematic reviews has received little attention. In this commentary, we discuss the potential benefits of coordinated efforts to share data collected as part of systematic reviews. Main body There are a number of potential benefits of systematic review data sharing. Shared information and data obtained as part of the systematic review process may reduce unnecessary duplication, reduce demand on trialist to service repeated requests from reviewers for data, and improve the quality and efficiency of future reviews. Sharing also facilitates research to improve clinical trial and systematic review methods and supports additional analyses to address secondary research questions. While concerns regarding appropriate use of data, costs, or the academic return for original review authors may impede more open access to information extracted as part of systematic reviews, many of these issues are being addressed, and infrastructure to enable greater access to such information is being developed. Conclusion Embracing systems to enable more open access to systematic review data has considerable potential to maximise the benefits of research investment in undertaking systematic reviews.

  5. Rating of Included Trials on the Efficacy–Effectiveness Spectrum : development of a new tool for systematic reviews

    NARCIS (Netherlands)

    Wieland, L. Susan; Berman, Brian M.; Altman, Douglas G.; Barth, Jürgen; Bouter, Lex M.; D'Adamo, Christopher R.; Linde, Klaus; Moher, David; Mullins, C. Daniel; Treweek, Shaun; Tunis, Sean; van der Windt, Danielle A.; Zwarenstein, Merrick; Witt, Claudia

    2017-01-01

    Background and Objective Randomized trials may be designed to provide evidence more strongly related to efficacy or effectiveness of an intervention. When systematic reviews are used to inform clinical or policy decisions, it is important to know the efficacy–effectiveness nature of the included

  6. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose).

    Science.gov (United States)

    Morrison, Nick; Gibson, Kathleen; McEnroe, Scott; Goldman, Mitchel; King, Ted; Weiss, Robert; Cher, Daniel; Jones, Andrew

    2015-04-01

    Whereas thermal ablation of incompetent saphenous veins is highly effective, all heat-based ablation techniques require the use of perivenous subfascial tumescent anesthesia, involving multiple needle punctures along the course of the target vein. Preliminary evidence suggests that cyanoacrylate embolization (CAE) may be effective in the treatment of incompetent great saphenous veins (GSVs). We report herein early results of a randomized trial of CAE vs radiofrequency ablation (RFA) for the treatment of symptomatic incompetent GSVs. Two hundred twenty-two subjects with symptomatic GSV incompetence were randomly assigned to receive either CAE (n = 108) with the VenaSeal Sapheon Closure System (Sapheon, Inc, Morrisville, NC) or RFA (n = 114) with the ClosureFast system (Covidien, Mansfield, Mass). After discharge, subjects returned to the clinic on day 3 and again at months 1 and 3. The study's primary end point was closure of the target vein at month 3 as assessed by duplex ultrasound and adjudicated by an independent vascular ultrasound core laboratory. Statistical testing focused on showing noninferiority with a 10% delta conditionally followed by superiority testing. No adjunctive procedures were allowed until after the month 3 visit, and missing month 3 data were imputed by various methods. Secondary end points included patient-reported pain during vein treatment and extent of ecchymosis at day 3. Additional assessments included general and disease-specific quality of life surveys and adverse event rates. All subjects received the assigned intervention. By use of the predictive method for imputing missing data, 3-month closure rates were 99% for CAE and 96% for RFA. All primary end point analyses, which used various methods to account for the missing data rate (14%), showed evidence to support the study's noninferiority hypothesis (all P ecchymosis in the treated region was present after CAE compared with RFA (P ecchymosis. Copyright © 2015 Society for Vascular

  7. Effect on attendance by including focused information on spirometry in preventive health checks: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ørts, Lene Maria; Løkke, Anders; Bjerregaard, Anne-Louise; Maindal, Helle Terkildsen; Sandbæk, Annelli

    2016-12-01

    Early detection of lung diseases can help to reduce their severity. Lung diseases are among the most frequently occurring and serious diseases worldwide; nonetheless, many patients remain undiagnosed. Preventive health checks including spirometry can detect lung diseases at early stages; however, recruitment for health checks remains a challenge, and little is known about what motivates the attendance. The aim of the study is to examine whether focused information on spirometry in the invitation compared to general information will impact the attendance rate in preventive health checks. This randomized, controlled trial tests the effect of information on spirometry embedded in the Check your Health Preventive Program (CHPP). The CHPP is an open-label, household cluster-randomized, controlled trial offering a preventive health check to 30- to -49-year-olds in a Danish municipality from 2012 to 2017 (n = 26,216). During 2015-2016, 4356 citizens aged 30-49 years will be randomized into two groups. The intervention group receives an invitation which highlights the value and contents of spirometry as part of a health check and information about lung diseases. The comparison group receives a standard invitation containing practical information and specifies the contents of the general health check. Outcomes are (1) differences in attendance rates measured by the proportion of citizens attending each of the two study groups and (2) proportion of persons at risk defined by smoking status and self-reported lung symptoms in the study groups. The proportion of participants with abnormal spirometry assessed at the preventive health check will be compared between the two study groups. The results from the present study will inform future recruitment strategies to health checks. The developed material on content, value, and information about lung disease is feasible and transferable to other populations, making it easy to implement if effective. ClinicalTrials.gov: NCT

  8. Closing the knowledge gap on cardiovascular disease in type 2 diabetes: the EMPA-REG OUTCOME trial and beyond

    Directory of Open Access Journals (Sweden)

    Elif A Oral

    2016-09-01

    Full Text Available Type 2 diabetes mellitus (T2DM is associated with marked cardiovascular (CV morbidity and mortality, including heartfailure (HF. Until recently, an oral glucose-lowering agent that improved hyperglycemia as well as provided CV benefits in patients with T2DM and cardiovascular disease (CVD was lacking. The newest class of glucose-lowering agents, sodium glucose cotransporter 2 (SGLT2 inhibitors, includes canagliflozin, dapagliflozin, and empagliflozin. Prior to the release of the LEADER trial results, the recent EMPA-REG OUTCOME study was the only dedicated CV trial to demonstrate a reduction in major adverse cardiac events, CV mortality, and all-cause mortality and a reduction in hospitalization for HF with empagliflozin, given on top of standard-of-care therapy in patients with T2DM and CVD. This paper summarizes the results from EMPA-REG OUTCOME and discusses their significance and clinical implications.

  9. Robustness Assessments Are Needed to Reduce Bias in Meta-Analyses That Include Zero-Event Randomized Trials

    NARCIS (Netherlands)

    Keus, F.; Wetterslev, J.; Gluud, C.; Gooszen, H. G.; van Laarhoven, C. J. H. M.

    OBJECTIVES: Meta-analysis of randomized trials with binary data can use a variety of statistical methods. Zero-event trials may create analytic problems. We explored how different methods may impact inferences from meta-analyses containing zero-event trials. METHODS: Five levels of statistical

  10. Robustness assessments are needed to reduce bias in meta-analyses that include zero-event randomized trials.

    NARCIS (Netherlands)

    Keus, F.; Wetterslev, J.; Gluud, C.; Gooszen, H.G.; Laarhoven, C.J.H.M. van

    2009-01-01

    OBJECTIVES: Meta-analysis of randomized trials with binary data can use a variety of statistical methods. Zero-event trials may create analytic problems. We explored how different methods may impact inferences from meta-analyses containing zero-event trials. METHODS: Five levels of statistical

  11. Diverse Cone-Snail Species Harbor Closely Related Streptomyces Species with Conserved Chemical and Genetic Profiles, Including Polycyclic Tetramic Acid Macrolactams

    Directory of Open Access Journals (Sweden)

    Michelle Quezada

    2017-11-01

    Full Text Available Streptomyces are Gram-positive bacteria that occupy diverse ecological niches including host-associations with animals and plants. Members of this genus are known for their overwhelming repertoire of natural products, which has been exploited for almost a century as a source of medicines and agrochemicals. Notwithstanding intense scientific and commercial interest in Streptomyces natural products, surprisingly little is known of the intra- and/or inter-species ecological roles played by these metabolites. In this report we describe the chemical structures, biological properties, and biosynthetic relationships between natural products produced by Streptomyces isolated from internal tissues of predatory Conus snails, collected from the Great Barrier Reef, Australia. Using chromatographic, spectroscopic and bioassays methodology, we demonstrate that Streptomyces isolated from five different Conus species produce identical chemical and antifungal profiles – comprising a suite of polycyclic tetramic acid macrolactams (PTMs. To investigate possible ecological (and evolutionary relationships we used genome analyses to reveal a close taxonomic relationship with other sponge-derived and free-living PTM producing Streptomyces (i.e., Streptomyces albus. In-depth phylogenomic analysis of PTM biosynthetic gene clusters indicated PTM structure diversity was governed by a small repertoire of genetic elements, including discrete gene acquisition events involving dehydrogenases. Overall, our study shows a Streptomyces-Conus ecological relationship that is concomitant with specific PTM chemical profiles. We provide an evolutionary framework to explain this relationship, driven by anti-fungal properties that protect Conus snails from fungal pathogens.

  12. A comparison of different ways of including baseline counts in negative binomial models for data from falls prevention trials.

    Science.gov (United States)

    Zheng, Han; Kimber, Alan; Goodwin, Victoria A; Pickering, Ruth M

    2018-01-01

    A common design for a falls prevention trial is to assess falling at baseline, randomize participants into an intervention or control group, and ask them to record the number of falls they experience during a follow-up period of time. This paper addresses how best to include the baseline count in the analysis of the follow-up count of falls in negative binomial (NB) regression. We examine the performance of various approaches in simulated datasets where both counts are generated from a mixed Poisson distribution with shared random subject effect. Including the baseline count after log-transformation as a regressor in NB regression (NB-logged) or as an offset (NB-offset) resulted in greater power than including the untransformed baseline count (NB-unlogged). Cook and Wei's conditional negative binomial (CNB) model replicates the underlying process generating the data. In our motivating dataset, a statistically significant intervention effect resulted from the NB-logged, NB-offset, and CNB models, but not from NB-unlogged, and large, outlying baseline counts were overly influential in NB-unlogged but not in NB-logged. We conclude that there is little to lose by including the log-transformed baseline count in standard NB regression compared to CNB for moderate to larger sized datasets. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  13. Does ceasing exercise induce depressive symptoms? A systematic review of experimental trials including immunological and neurogenic markers.

    Science.gov (United States)

    Morgan, Julie A; Olagunju, Andrew T; Corrigan, Frances; Baune, Bernhard T

    2018-02-24

    Regular exercise in adults improves depressive symptoms (DS) and major depressive disorder (MDD), however the clinical effects of ceasing exercise are largely unknown. Seven databases were searched from inception to December 2017. Eligibility criteria included English language studies investigating the effects of ceasing exercise on DS or MDD in regularly active adults with or without prior DS or MDD. Blood based markers related to exercise cessation (EC) were assessed, if recorded. Studies investigating exercise follow-up periods were excluded. No studies investigated EC in MDD. Six studies including two RCTS and three studies investigating neurogenic and immune biological markers associated with DS met inclusion criteria (152 healthy adults, females n = 50/32.89%). Compared to baseline, EC increased DS after three days, one week, and two weeks. Female participants had significantly more DS than male participants. Following EC, no changes in brain derived neurotrophic factor (BDNF) or tumour necrosis factor alpha (TNF) were evident, however C-reactive protein (CRP) at week one and interleukin 6 (IL6) at week two were reduced. Quality concerns including risks of attrition and reporting bias limit our confidence in these results. Ceasing regular exercise increases DS in healthy adults, with greater DS in females than males. Contrary to the cytokine/inflammatory hypothesis of depression, DS were associated with reduced CRP and IL6 and without increased TNF. High quality trials are needed to extend this field of research in both healthy and MDD populations. Copyright © 2018 Elsevier B.V. All rights reserved.

  14. Rationale and methodology for a multicentre randomised trial of fibrinolysis for pulmonary embolism that includes quality of life outcomes.

    Science.gov (United States)

    Kline, Jeffrey A; Hernandez, Jackeline; Hogg, Melanie M; Jones, Alan E; Courtney, D Mark; Kabrhel, Christopher; Nordenholz, Kristen E; Diercks, Deborah B; Rondina, Matthew T; Klinger, James R

    2013-12-01

    Submassive pulmonary embolism (PE) has a low mortality rate but can degrade functional capacity. The present study aims to provide rationale, methodology, and initial findings of a multicentre, randomised trial of fibrinolysis for PE that used a composite end-point, including quality of life measures. This investigator-initiated study was funded by a contract between a corporate partner and the investigator's hospital (the prime site). The investigator was the Food and Drug Administration (FDA) sponsor. The prime site subcontracted, indemnified, and trained consortia members. Consenting, normotensive patients with PE and right ventricular strain (by echocardiography or biomarkers) received low-molecular-weight heparin and random assignment to a single bolus of tenecteplase or placebo in double-blinded fashion. The outcomes were: (i) in-hospital rate of intubation, vasopressor support, and major haemorrhage, or (ii) at 90 days, death, recurrent PE, or composite that defined poor quality of life (echocardiography, 6 min walk test and surveys). The planned sample size was n = 200. Eight sites enrolled 87 patients over 5 years. The ratio of patients screened for each enrolled was 7.4 to 1, equating to 11 h screening time per patient enrolled. Primary barrier to enrolment was the cost of screening. Two patients died (2.5%, 95%CI [0-8%]), one developed shock, but 18 (22%, 95%CI: [13-30%]) had a poor quality of life. An investigator-initiated, FDA-regulated, multicentre trial of fibrinolysis for submassive PE was conducted, but was limited by screening costs and a low mortality rate. Quality of life measurements might represent a more important patient-centred end-point. © 2013 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  15. Three dimensional model for particle saltation close to stream beds, including a detailed description of the particle interaction with turbulence and inter-particle collisions

    KAUST Repository

    Moreno, Pablo M.

    2011-05-19

    We present in this paper a new three-dimensional (3-D) model for bed-load sediment transport, based on a Lagrangian description. We analyze generalized sub-models for the velocities after collision and the representation of the bed-roughness. The free-flight sub-model includes the effect of several forces, such as buoyancy, drag, virtual mass, lift, Basset and Magnus, and also addresses the particle rotation. A recent methodology for saving computational time in the Basset force is also employed. The sub-models for the post-collision velocity and rotation are based on the conservation of linear and angular momentum during the collision with the bed. We develop a new 3-D representation for the bed roughness by using geometric considerations. In order to address the interaction of particles with the turbulent flow, we tracked the particles through a computed turbulent velocity field for a smooth flat plate. This velocity field was used as a surrogate of the 3-D turbulent conditions close to the bed in streams. We first checked that the basic turbulence statistics for this velocity field could be used to approximate those in an open-channel flow. We then analyzed the interaction of the sediment and the turbulence for a single and multiple particles. We compared numerical results with experimental data obtained by Niño and García (1998b). We show that model predictions are in good agreement with existing data, in the sand size range. © 2011 ASCE.

  16. Protocol for the immediate delivery versus expectant care of women with preterm prelabour rupture of the membranes close to term (PPROMT Trial [ISRCTN44485060

    Directory of Open Access Journals (Sweden)

    Buchanan Sarah L

    2006-03-01

    Full Text Available Abstract Background Preterm prelabour rupture of membranes (PPROM complicates up to 2% of all pregnancies and is the cause of 40% of all preterm births. The optimal management of women with PPROM prior to 37 weeks, is not known. Furthermore, diversity in current clinical practice suggests uncertainty about the appropriate clinical management. There are two options for managing PPROM, expectant management (a wait and see approach or early planned birth. Infection is the main risk for women in which management is expectant. This risk need to be balanced against the risk of iatrogenic prematurity if early delivery is planned. The different treatment options may also have different health care costs. Expectant management results in prolonged antenatal hospitalisation while planned early delivery may necessitate intensive care of the neonate for problems associated with prematurity. Methods/Design We aim to evaluate the effectiveness of early planned birth compared with expectant management for women with PPROM between 34 weeks and 366 weeks gestation, in a randomised controlled trial. A secondary aim is a cost analysis to establish the economic impact of the two treatment options and establish the treatment preferences of women with PPROM close to term. The early planned birth group will be delivered within 24 hours according to local management protocols. In the expectant management group birth will occur after spontaneous labour, at term or when the attending clinician feels that birth is indicated according to usual care. Approximately 1812 women with PPROM at 34–366 weeks gestation will be recruited for the trial. The primary outcome of the study is neonatal sepsis. Secondary infant outcomes include respiratory distress, perinatal mortality, neonatal intensive care unit admission, assisted ventilation and early infant development. Secondary maternal outcomes include chorioamnionitis, postpartum infection treated with antibiotics, antepartum

  17. Transition rates from schizotypal disorder to psychotic disorder for first-contact patients included in the OPUS trial. A randomized clinical trial of integrated treatment and standard treatment

    DEFF Research Database (Denmark)

    Nordentoft, Merete; Thorup, Anne; Petersen, Lone

    2006-01-01

    Only a few randomized clinical trials have tested the effect on transition rates of intervention programs for patients with sub-threshold psychosis-like symptoms.......Only a few randomized clinical trials have tested the effect on transition rates of intervention programs for patients with sub-threshold psychosis-like symptoms....

  18. Quality assessment of delineation and dose planning of early breast cancer patients included in the randomized Skagen Trial 1

    DEFF Research Database (Denmark)

    Francolini, Giulio; Thomsen, Mette S; Yates, Esben S

    2017-01-01

    BACKGROUND AND PURPOSE: To report on a Quality assessment (QA) of Skagen Trial 1, exploring hypofractionation for breast cancer patients with indication for regional nodal radiotherapy. MATERIAL AND METHODS: Deviations from protocol regarding target volume delineations and dose parameters (Dmin...

  19. One- and two-incision anterior cruciate ligament reconstruction: a biomechanical comparison including the effect of simulated closed-chain exercise.

    Science.gov (United States)

    Dalldorf, P G; Alexander, J; Lintner, D M

    1998-03-01

    The purpose of this study was to evaluate the effect of simulated closed-chain exercise on anterior translation in the anterior cruciate ligament (ACL) reconstructed knee comparing patellar tendon grafts secured with endoscopic and two-incision techniques. ACL reconstructions, were performed on five matched pairs of fresh frozen cadaver lower extremities. One of each pair had endoscopic (inside-out) placement of the femoral interference screw and other had outside-in femoral screw placement. A model for closed-chain exercise was developed to simulate half squat exercises using a custom apparatus on the Material Testing machine with a 356 N (80 lb) axial load and 40 N (9 lb) static hamstring force. Knee motion from near full extension to 60 degrees flexion was achieved by varying the quadricep force. One thousand squats were performed, and KT-1000 arthometry was done before and after cycling each specimen. The femur-graft-tibia constructs were then stressed to failure. Closed-chain cycling resulted in no significant change in anterior translation in either group. The mean maximum load to failure of the femur-graft-tibia construct was 340.4N in the one-incision group and 434.2 N in the two-incision group. P=.048 was considered statistically significant. Anterior translation did not increase after 1,000 simulated half knee bends in either the one- or two-incision groups. Shallow knee bends are an important part of aggressive rehabilitation programs, and our data support the position that these closed-chain exercises do not deleteriously affect the graft. Though the maximum strength to failure differed significantly between the one- and two-incision groups, both techniques offered sufficient strength to withstand an aggressive simulated rehabilitation protocol.

  20. Can the FDA improve oversight of foreign clinical trials?: Closing the information gap and moving towards a globalized regulatory scheme.

    Science.gov (United States)

    Ourso, André

    2012-01-01

    Currently, pharmaceutical companies' utilization of foreign clinical trial data is a ubiquitous and indispensable aspect of gaining approval to market drugs in the United States. Cost benefits, a larger pool of ready volunteer subjects, and greater efficiency in clinical testing are some of the reasons for conducting clinical trials overseas. Despite these advantages, lack of proper oversight may have serious public health implications regarding the integrity of clinical research, ethical treatment of human subjects, and drug safety. Due to the expansive global nature of foreign clinical trials, there are concerns with the FDA's ability to monitor and regulate these trials. This article examines the FDA's oversight of foreign clinical trials and the agency's limitations regulating these trials. In addition to looking at steps the FDA is taking to address these limitations, the article examines other potential regulatory and cooperative actions that can be taken to effectively monitor foreign clinical trials and to ensure data integrity and patient safety.

  1. Efficacy of physiotherapy including a craniocervical training programme for tension-type headache; a randomized clinical trial

    NARCIS (Netherlands)

    van Ettekoven, H.; Lucas, C.

    2006-01-01

    We conducted a multicentre, randomized controlled trial with blinded outcome assessment. The treatment period was 6 weeks with follow-up assessment immediately thereafter and after 6 months. The objective was to determine the effectiveness of a craniocervical training programme combined with

  2. Complete blood count risk score and its components, including RDW, are associated with mortality in the JUPITER trial.

    Science.gov (United States)

    Horne, Benjamin D; Anderson, Jeffrey L; Muhlestein, Joseph B; Ridker, Paul M; Paynter, Nina P

    2015-04-01

    Previously, we showed that sex-specific complete blood count (CBC) risk scores strongly predicted risk of all-cause mortality in multiple sets of general medical patients. This study evaluated the CBC risk score in an independent, well-studied international primary risk population of lower-risk individuals initially free from cardiovascular (CV) disease. Observational secondary analysis of a randomized trial population. The previously derived and validated CBC score was evaluated for association with all-cause mortality among CV disease-free females (n = 6568) and males (n = 10,629) enrolled for up to 5 years in the Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial. Associations of the CBC score with CV mortality and with major CV disease were also tested. The CBC score predicted all-cause mortality, with univariable hazard ratio (HR) 4.83 (95% CI 3.70-6.31) for the third CBC score tertile vs. the first tertile, and HR 2.31 (CI 1.75-3.05) for the second tertile (p trend JUPITER endpoint (p trend = 0.015). c-statistics for mortality were 0.729 among all, and 0.722 and 0.750 for females and males, respectively. The CBC risk score was strongly associated with all-cause mortality among JUPITER trial participants and had good discrimination. It also predicted CV-specific outcomes. This CBC score may be useful in identifying cardiac disease-free individuals at increased risk of mortality. © The European Society of Cardiology 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  3. Effect of including fitness testing in preventive health checks on cardiorespiratory fitness and motivation: study protocol of a randomized controlled trial.

    Science.gov (United States)

    Høj, Kirsten; Skriver, Mette Vinther; Hansen, Anne-Louise Smidt; Christensen, Bo; Maindal, Helle Terkildsen; Sandbæk, Annelli

    2014-10-10

    Preventive health checks may identify individuals with an unhealthy lifestyle and motivate them to change behaviour. However, knowledge about the impact of the different components included in preventive health checks is deficient. The aim of this trial is to evaluate whether including cardiorespiratory fitness testing in preventive health checks 1) increases cardiorespiratory fitness level and motivation to change physical activity behaviour and 2) reduces physical inactivity prevalence and improves self-rated health compared with preventive health checks without fitness testing. An open-label, household-cluster, randomized controlled trial with a two-group parallel design is used. The trial is embedded in a population-based health promotion program, "Check your Health Preventive Program", in which all 30-49 year-old citizens in a Danish municipality are offered a preventive health check. In each arm of the trial, 750 citizens will be recruited (1,500 in total). The primary outcome is cardiorespiratory fitness level assessed by submaximal cycle ergometer testing after one year. An intermediate outcome is the percentage of participants increasing motivation for physical activity behaviour change between baseline and two-weeks follow-up assessed using the Transtheoretical Model's stages of change. Secondary outcomes include changes from baseline to one-year follow-up in physical inactivity prevalence measured by a modified version of the questions developed by Saltin and Grimby, and in self-rated health measures using the Short-Form 12, Health Survey, version 2. This trial will contribute to a critical appraisal of the value of fitness testing as part of preventive health checks. The conduction in real-life community and general practice structures makes the trial findings applicable and transferable to other municipalities providing support to decision-makers in the development of approaches to increase levels of physical activity and improve health. ClinicalTrials

  4. Completed and attempted suicides among 18,154 subjects with schizophrenia included in a large simple trial.

    Science.gov (United States)

    Fleischhacker, W Wolfgang; Kane, John M; Geier, Jamie; Karayal, Onur; Kolluri, Sheela; Eng, Sybil M; Reynolds, Robert F; Strom, Brian L

    2014-03-01

    To characterize subgroups of subjects with schizophrenia from the Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC) trial who either completed or attempted suicide and those who did not. The ZODIAC, conducted between February 2002 and March 2007, was an open-label, randomized, large simple trial of patients with schizophrenia (N = 18,154) followed up for 1 year by unblinded investigators providing usual care in 18 countries; the primary outcome measure was nonsuicide mortality. Every report on a completed or attempted suicide was independently adjudicated using a predefined algorithm. Primary analysis for the current report examined the association between completed or attempted suicides and the baseline variables using descriptive statistics and multivariate logistic regression models. Usage of "hard" or "soft" methods for attempted or completed suicide and distribution of suicide-related events by geographical region were also summarized. Overall incidences of subjects who either completed (35/18,154) or attempted (108/18,154) suicide were low, as were rates per person-time on assigned treatment analysis (0.24 for completed and 0.74 for attempted suicides per 100 person-years of exposure). The highest suicide-related mortality was seen among subjects recently diagnosed with schizophrenia. Among all potential baseline risk factors for completed suicide examined, the variables most associated with completed suicide were history of suicide attempts (OR = 2.6; 95% CI, 1.33-5.12) and usage of antidepressant medication (OR = 3.5; 95% CI, 0.84-14.85). History of > 5 hospitalizations in the past (OR = 2.1; 95% CI, 1.35-3.31) and history of suicide attempts (OR = 5.0; 95% CI, 3.21-7.76) were the variables most associated with attempted suicide among potential baseline risk factors for suicide attempts. Our results, obtained in a large prospective randomized study, confirm current clinical understanding regarding completed or attempted suicide in schizophrenia

  5. Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study.

    Science.gov (United States)

    Dechartres, Agnes; Trinquart, Ludovic; Atal, Ignacio; Moher, David; Dickersin, Kay; Boutron, Isabelle; Perrodeau, Elodie; Altman, Douglas G; Ravaud, Philippe

    2017-06-08

    Objective  To examine how poor reporting and inadequate methods for key methodological features in randomised controlled trials (RCTs) have changed over the past three decades. Design  Mapping of trials included in Cochrane reviews. Data sources  Data from RCTs included in all Cochrane reviews published between March 2011 and September 2014 reporting an evaluation of the Cochrane risk of bias items: sequence generation, allocation concealment, blinding, and incomplete outcome data. Data extraction  For each RCT, we extracted consensus on risk of bias made by the review authors and identified the primary reference to extract publication year and journal. We matched journal names with Journal Citation Reports to get 2014 impact factors. Main outcomes measures  We considered the proportions of trials rated by review authors at unclear and high risk of bias as surrogates for poor reporting and inadequate methods, respectively. Results  We analysed 20 920 RCTs (from 2001 reviews) published in 3136 journals. The proportion of trials with unclear risk of bias was 48.7% for sequence generation and 57.5% for allocation concealment; the proportion of those with high risk of bias was 4.0% and 7.2%, respectively. For blinding and incomplete outcome data, 30.6% and 24.7% of trials were at unclear risk and 33.1% and 17.1% were at high risk, respectively. Higher journal impact factor was associated with a lower proportion of trials at unclear or high risk of bias. The proportion of trials at unclear risk of bias decreased over time, especially for sequence generation, which fell from 69.1% in 1986-1990 to 31.2% in 2011-14 and for allocation concealment (70.1% to 44.6%). After excluding trials at unclear risk of bias, use of inadequate methods also decreased over time: from 14.8% to 4.6% for sequence generation and from 32.7% to 11.6% for allocation concealment. Conclusions  Poor reporting and inadequate methods have decreased over time, especially for sequence generation

  6. Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple-level designs.

    Science.gov (United States)

    Hemming, Karla; Lilford, Richard; Girling, Alan J

    2015-01-30

    Stepped-wedge cluster randomised trials (SW-CRTs) are being used with increasing frequency in health service evaluation. Conventionally, these studies are cross-sectional in design with equally spaced steps, with an equal number of clusters randomised at each step and data collected at each and every step. Here we introduce several variations on this design and consider implications for power. One modification we consider is the incomplete cross-sectional SW-CRT, where the number of clusters varies at each step or where at some steps, for example, implementation or transition periods, data are not collected. We show that the parallel CRT with staggered but balanced randomisation can be considered a special case of the incomplete SW-CRT. As too can the parallel CRT with baseline measures. And we extend these designs to allow for multiple layers of clustering, for example, wards within a hospital. Building on results for complete designs, power and detectable difference are derived using a Wald test and obtaining the variance-covariance matrix of the treatment effect assuming a generalised linear mixed model. These variations are illustrated by several real examples. We recommend that whilst the impact of transition periods on power is likely to be small, where they are a feature of the design they should be incorporated. We also show examples in which the power of a SW-CRT increases as the intra-cluster correlation (ICC) increases and demonstrate that the impact of the ICC is likely to be smaller in a SW-CRT compared with a parallel CRT, especially where there are multiple levels of clustering. Finally, through this unified framework, the efficiency of the SW-CRT and the parallel CRT can be compared. © 2014 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

  7. The effectiveness of a specially designed shoulder chair for closed reduction of acute shoulder dislocation in the emergency department: a randomised control trial.

    Science.gov (United States)

    Chung, Josephine Yuen Man; Cheng, Chi Hung; Graham, Colin A; Rainer, Timothy H

    2013-10-01

    The objective of this study was to demonstrate the effectiveness of a specially designed chair for closed reduction of acute shoulder dislocations. This was a prospective, non-blinded randomised controlled trial conducted in a university affiliated emergency department (ED). The inclusion criteria were (1) age ≥18 years; (2) anterior or posterior shoulder dislocation without fracture of the surgical neck of the humerus; (3) patient who is able to communicate and cooperate. Participants were randomly assigned using a computer generated random number sequence into one of two groups--either the traditional practice group or Oxford chair group. Administration of intravenous sedation was only permitted in the traditional practice group due to the concerns of sedation use in the sitting position while unsupported on the chair. The primary outcome measure was length of ED stay. The secondary outcome measures were length of time for the procedure, successful reduction rate, levels of pain experienced by patients in different time periods before and after the reduction. Sixty eligible patients were recruited, 30 in each group. The median lengths of stay in the ED in Oxford chair group (n=30) and traditional method group (n=30) were 152 min and 173 min respectively (p=0.183). The median procedure time was 3 min for the Oxford chair group compared to 5 min in the traditional method group (p=0.179). The success rate for the Oxford chair method was 77% (23/30). There were no statistically or clinically significant differences of pain score at any point. The chair method had a 77% success rate in reducing acute shoulder dislocations without sedation. There was no difference in pain level experienced by patients between the chair method and the traditional method. Patient factors, including patients who have had previous shoulder surgery and patients who have fracture dislocations, contribute to the reduced efficacy of the chair method. It remains possible that the chair method

  8. Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial.

    Science.gov (United States)

    Griffin, Damian; Parsons, Nick; Shaw, Ewart; Kulikov, Yuri; Hutchinson, Charles; Thorogood, Margaret; Lamb, Sarah E

    2014-07-24

    To investigate whether surgery by open reduction and internal fixation provides benefit compared with non-operative treatment for displaced, intra-articular calcaneal fractures. Pragmatic, multicentre, two arm, parallel group, assessor blinded randomised controlled trial (UK Heel Fracture Trial). 22 tertiary referral hospitals, United Kingdom. 151 patients with acute displaced intra-articular calcaneal fractures randomly allocated to operative (n=73) or non-operative (n=78) treatment. The primary outcome measure was patient reported Kerr-Atkins score for pain and function (scale 0-100, 100 being the best possible score) at two years after injury. Secondary outcomes were complications; hindfoot pain and function (American Orthopaedic Foot and Ankle Society score); general health (SF-36); quality of life (EQ-5D); clinical examination; walking speed; and gait symmetry. Analysis was by intention to treat. 95% follow-up was achieved for the primary outcome (69 in operative group and 74 in non-operative group), and a complete set of secondary outcomes were available for 75% of participants. There was no significant difference in the primary outcome (mean Kerr-Atkins score 69.8 in operative group v 65.7 in non-operative group; adjusted 95% confidence interval of difference -7.1 to 7.0) or in any of the secondary outcomes between treatment groups. Complications and reoperations were more common in those who received operative care (estimated odds ratio 7.5, 95% confidence interval 2.0 to 41.8). Operative treatment compared with non-operative care showed no symptomatic or functional advantage after two years in patients with typical displaced intra-articular fractures of the calcaneus, and the risk of complications was higher after surgery. Based on these findings, operative treatment by open reduction and internal fixation is not recommended for these fractures.Trial registration Current Controlled Trials ISRCTN37188541. © Griffin et al 2014.

  9. An exploratory randomised controlled trial of a premises-level intervention to reduce alcohol-related harm including violence in the United Kingdom

    Directory of Open Access Journals (Sweden)

    Moore Simon C

    2012-06-01

    Full Text Available Abstract Background To assess the feasibility of a randomised controlled trial of a licensed premises intervention to reduce severe intoxication and disorder; to establish effect sizes and identify appropriate approaches to the development and maintenance of a rigorous research design and intervention implementation. Methods An exploratory two-armed parallel randomised controlled trial with a nested process evaluation. An audit of risk factors and a tailored action plan for high risk premises, with three month follow up audit and feedback. Thirty-two premises that had experienced at least one assault in the year prior to the intervention were recruited, match paired and randomly allocated to control or intervention group. Police violence data and data from a street survey of study premises’ customers, including measures of breath alcohol concentration and surveyor rated customer intoxication, were used to assess effect sizes for a future definitive trial. A nested process evaluation explored implementation barriers and the fidelity of the intervention with key stakeholders and senior staff in intervention premises using semi-structured interviews. Results The process evaluation indicated implementation barriers and low fidelity, with a reluctance to implement the intervention and to submit to a formal risk audit. Power calculations suggest the intervention effect on violence and subjective intoxication would be raised to significance with a study size of 517 premises. Conclusions It is methodologically feasible to conduct randomised controlled trials where licensed premises are the unit of allocation. However, lack of enthusiasm in senior premises staff indicates the need for intervention enforcement, rather than voluntary agreements, and on-going strategies to promote sustainability. Trial registration UKCRN 7090; ISRCTN: 80875696

  10. A randomized controlled trial of Internet-Based Cognitive Behavior Therapy for perfectionism including an investigation of outcome predictors.

    Science.gov (United States)

    Rozental, Alexander; Shafran, Roz; Wade, Tracey; Egan, Sarah; Nordgren, Lise Bergman; Carlbring, Per; Landström, Andreas; Roos, Stina; Skoglund, Malin; Thelander, Elisabet; Trosell, Linnéa; Örtenholm, Alexander; Andersson, Gerhard

    2017-08-01

    Being highly attentive to details can be a positive feature. However, for some individuals, perfectionism can lead to distress and is associated with many psychiatric disorders. Cognitive behavior therapy has been shown to yield many benefits for those experiencing problems with perfectionism, but the access to evidence-based care is limited. The current study investigated the efficacy of guided Internet-based Cognitive Behavior Therapy (ICBT) and predictors of treatment outcome. In total, 156 individuals were included and randomized to an eight-week treatment or wait-list control. Self-report measures of perfectionism, depression, anxiety, self-criticism, self-compassion, and quality of life were distributed during screening and at post-treatment. Intention-to-treat were used for all statistical analyses. Moderate to large between-group effect sizes were obtained for the primary outcome measures, Frost Multidimensional Perfectionism Scale, subscales Concerns over Mistakes and Personal Standards, Cohen's d = 0.68-1.00, 95% Confidence Interval (CI) [0.36-1.33], with 35 (44.9%) of the patients in treatment being improved. Predictors were also explored, but none were related to treatment outcome. In sum, guided ICBT can be helpful for addressing problems with clinical perfectionism, but research of its long-term benefits is warranted. Copyright © 2017 Elsevier Ltd. All rights reserved.

  11. Tocilizumab use in pregnancy: Analysis of a global safety database including data from clinical trials and post-marketing data.

    Science.gov (United States)

    Hoeltzenbein, Maria; Beck, Evelin; Rajwanshi, Richa; Gøtestam Skorpen, Carina; Berber, Erhan; Schaefer, Christof; Østensen, Monika

    2016-10-01

    Analyze the cumulative evidence for pregnancy outcomes after maternal exposure to tocilizumab, an anti-interleukin-6-receptor monoclonal antibody used for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis. At present, published experience on tocilizumab use during pregnancy is very limited. We have analyzed all pregnancy-related reports documented in the Roche Global Safety Database until December 31, 2014 (n = 501). After exclusion of ongoing pregnancies, duplicates, and cases retrieved from the literature, 399 women were found to have been exposed to tocilizumab shortly before or during pregnancy, with pregnancy outcomes being reported in 288 pregnancies (72.2%). Of these 288 pregnancies, 180 were prospectively reported resulting in 109 live births (60.6%), 39 spontaneous abortions (21.7%), 31 elective terminations of pregnancy (17.2%), and 1 stillbirth. The rate of malformations was 4.5%. Co-medications included methotrexate in 21.1% of the prospectively ascertained cases. Compared to the general population, an increased rate of preterm birth (31.2%) was observed. Retrospectively reported pregnancies (n = 108) resulted in 55 live births (50.9%), 31 spontaneous abortions (28.7%), and 22 elective terminations (20.4%). Three infants/fetuses with congenital anomalies were reported in this group. No increased risks for adverse pregnancy outcomes were observed after paternal exposure in 13 pregnancies with known outcome. No indication for a substantially increased malformation risk was observed. Considering the limitations of global safety databases, the data do not yet prove safety, but provide information for physicians and patients to make informed decisions. This is particularly important after inadvertent exposure to tocilizumab, shortly before or during early pregnancy. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Comparison of a 'freeze-all' strategy including GnRH agonist trigger versus a 'fresh transfer' strategy including hCG trigger in assisted reproductive technology (ART): a study protocol for a randomised controlled trial.

    Science.gov (United States)

    Stormlund, Sacha; Løssl, Kristine; Zedeler, Anne; Bogstad, Jeanette; Prætorius, Lisbeth; Nielsen, Henriette Svarre; Bungum, Mona; Skouby, Sven O; Mikkelsen, Anne Lis; Andersen, Anders Nyboe; Bergh, Christina; Humaidan, Peter; Pinborg, Anja

    2017-07-31

    Pregnancy rates after frozen embryo transfer (FET) have improved in recent years and are now approaching or even exceeding those obtained after fresh embryo transfer. This is partly due to improved laboratory techniques, but may also be caused by a more physiological hormonal and endometrial environment in FET cycles. Furthermore, the risk of ovarian hyperstimulation syndrome is practically eliminated in segmentation cycles followed by FET and the use of natural cycles in FETs may be beneficial for the postimplantational conditions of fetal development. However, a freeze-all strategy is not yet implemented as standard care due to limitations of large randomised trials showing a benefit of such a strategy. Thus, there is a need to test the concept against standard care in a randomised controlled design. This study aims to compare ongoing pregnancy and live birth rates between a freeze-all strategy with gonadotropin-releasing hormone (GnRH) agonist triggering versus human chorionic gonadotropin (hCG) trigger and fresh embryo transfer in a multicentre randomised controlled trial. Multicentre randomised, controlled, double-blinded trial of women undergoing assisted reproductive technology treatment including 424 normo-ovulatory women aged 18-39 years from Denmark and Sweden. Participants will be randomised (1:1) to either (1) GnRH agonist trigger and single vitrified-warmed blastocyst transfer in a subsequent hCG triggered natural menstrual cycle or (2) hCG trigger and single blastocyst transfer in the fresh (stimulated) cycle. The primary endpoint is to compare ongoing pregnancy rates per randomised patient in the two treatment groups after the first single blastocyst transfer. The study will be performed in accordance with the ethical principles in the Helsinki Declaration. The study is approved by the Scientific Ethical Committees in Denmark and Sweden. The results of the study will be publically disseminated. NCT02746562; Pre-results. © Article author(s) (or their

  13. Summary report on close-coupled subsurface barrier technology: Initial field trials to full-scale demonstration

    International Nuclear Information System (INIS)

    Heiser, J.H.

    1997-09-01

    The primary objective of this project was to develop and demonstrate the installation and measure the performance of a close-coupled barrier for the containment of subsurface waste or contaminant migration. A close-coupled barrier is produced by first installing a conventional, low-cost, cement-grout containment barrier followed by a thin lining of a polymer grout. The resultant barrier is a cement-polymer composite that has economic benefits derived from the cement and performance benefits from the durable and resistant polymer layer. The technology has matured from a regulatory investigation of the issues concerning the use of polymers to laboratory compatibility and performance measurements of various polymer systems to a pilot-scale, single column injection at Sandia to full-scale demonstration. The feasibility of the close-coupled barrier concept was proven in a full-scale cold demonstration at Hanford, Washington and then moved to the final stage with a full-scale demonstration at an actual remediation site at Brookhaven National Laboratory (BNL). At the Hanford demonstration the composite barrier was emplaced around and beneath a 20,000 liter tank. The secondary cement layer was constructed using conventional jet grouting techniques. Drilling was completed at a 45 degree angle to the ground, forming a cone-shaped barrier. The primary barrier was placed by panel jet-grouting with a dual-wall drill stem using a two part polymer grout. The polymer chosen was a high molecular weight acrylic. At the BNL demonstration a V-trough barrier was installed using a conventional cement grout for the secondary layer and an acrylic-gel polymer for the primary layer. Construction techniques were identical to the Hanford installation. This report summarizes the technology development from pilot- to full-scale demonstrations and presents some of the performance and quality achievements attained

  14. Summary report on close-coupled subsurface barrier technology: Initial field trials to full-scale demonstration

    Energy Technology Data Exchange (ETDEWEB)

    Heiser, J.H. [Brookhaven National Lab., Upton, NY (United States). Environmental and Waste Technology Center; Dwyer, B. [Sandia National Lab., Albuquerque, NM (United States)

    1997-09-01

    The primary objective of this project was to develop and demonstrate the installation and measure the performance of a close-coupled barrier for the containment of subsurface waste or contaminant migration. A close-coupled barrier is produced by first installing a conventional, low-cost, cement-grout containment barrier followed by a thin lining of a polymer grout. The resultant barrier is a cement-polymer composite that has economic benefits derived from the cement and performance benefits from the durable and resistant polymer layer. The technology has matured from a regulatory investigation of the issues concerning the use of polymers to laboratory compatibility and performance measurements of various polymer systems to a pilot-scale, single column injection at Sandia to full-scale demonstration. The feasibility of the close-coupled barrier concept was proven in a full-scale cold demonstration at Hanford, Washington and then moved to the final stage with a full-scale demonstration at an actual remediation site at Brookhaven National Laboratory (BNL). At the Hanford demonstration the composite barrier was emplaced around and beneath a 20,000 liter tank. The secondary cement layer was constructed using conventional jet grouting techniques. Drilling was completed at a 45{degree} angle to the ground, forming a cone-shaped barrier. The primary barrier was placed by panel jet-grouting with a dual-wall drill stem using a two part polymer grout. The polymer chosen was a high molecular weight acrylic. At the BNL demonstration a V-trough barrier was installed using a conventional cement grout for the secondary layer and an acrylic-gel polymer for the primary layer. Construction techniques were identical to the Hanford installation. This report summarizes the technology development from pilot- to full-scale demonstrations and presents some of the performance and quality achievements attained.

  15. Open- and Closed-Skill Exercise Interventions Produce Different Neurocognitive Effects on Executive Functions in the Elderly: A 6-Month Randomized, Controlled Trial

    Directory of Open Access Journals (Sweden)

    Chia-Liang Tsai

    2017-09-01

    Full Text Available This study aimed to explore the effects of open- and closed-skill exercise interventions on the neurocognitive performance of executive functions in the elderly. Sixty-four healthy elderly males were randomly assigned to either a closed-skill (bike riding or brisk walking/jogging, n = 22, open-skill (table tennis, n = 21, or control (n = 21 group. Various neuropsychological [e.g., accuracy rates (AR and reaction time (RT] and electrophysiological [e.g., event-related potential (ERP P3 component] measures were assessed during a variant of the task-switching paradigm, as well as an N-back task at baseline and after either a 6-month exercise intervention or control period. The results showed that, when performing the task-switching paradigm, the two exercise groups relative to control group showed significantly faster RTs in the switch trials after the exercise intervention. However, the RT facilitation in the non-switch and switch trials post-exercise relative to pre-exercise only emerged in the open-skill group. In terms of the N-back task, the two exercise groups significantly increased ARs in the 1-back condition after the exercise intervention, and the beneficial AR effect on the 2-back condition only emerged in the closed-skill group. In addition, the two exercise groups exhibited significantly larger P3 amplitudes on the frontal-to-parietal cortex areas after the exercise intervention relative to the baseline when performing the two cognitive tasks. These neurocognitive results still remained unchanged even when the confounding factors (e.g., cardiorespiratory fitness, social participation, and BMI were controlled for. The present study concluded that, although 6-month open- and closed-skill exercise interventions facilitate overall electrophysiological effects (i.e., increased ERP P3 amplitudes on the frontal-to-parietal cortices in the elderly, the two exercise modes produced different levels of neuropsychologically beneficial effects on

  16. Including pork in the Mediterranean diet for an Australian population: Protocol for a randomised controlled trial assessing cardiovascular risk and cognitive function.

    Science.gov (United States)

    Wade, Alexandra T; Davis, Courtney R; Dyer, Kathryn A; Hodgson, Jonathan M; Woodman, Richard J; Keage, Hannah A D; Murphy, Karen J

    2017-12-22

    The Mediterranean diet is characterised by the high consumption of extra virgin olive oil, fruits, vegetables, grains, legumes and nuts; moderate consumption of fish, poultry, eggs and dairy; and low consumption of red meat and sweets. Cross sectional, longitudinal and intervention studies indicate that a Mediterranean diet may be effective for the prevention of cardiovascular disease and dementia. However, previous research suggests that an Australian population may find red meat restrictions difficult, which could affect long term sustainability of the diet. This paper outlines the protocol for a randomised controlled trial that will assess the cardiovascular and cognitive benefits of a Mediterranean diet modified to include 2-3 weekly serves of fresh, lean pork. A 24-week cross-over design trial will compare a modified Mediterranean diet with a low-fat control diet in at-risk men and women. Participants will follow each of the two diets for 8 weeks, with an 8-week washout period separating interventions. Home measured systolic blood pressure will be the primary outcome measure. Secondary outcomes will include body mass index, body composition, fasting blood lipids, C-reactive protein, fasting plasma glucose, fasting serum insulin, erythrocyte fatty acids, cognitive function, psychological health and well-being, and dementia risk. To our knowledge this research is the first to investigate whether an alternate source of protein can be included in the Mediterranean diet to increase sustainability and feasibility for a non-Mediterranean population. Findings will be significant for the prevention of cardiovascular disease and age-related decline, and may inform individuals, clinicians and public health policy. ACTRN12616001046493 . Registered 5 August 2016.

  17. Including the Copenhagen Adduction Exercise in the FIFA 11+ Provides Missing Eccentric Hip Adduction Strength Effect in Male Soccer Players: A Randomized Controlled Trial.

    Science.gov (United States)

    Harøy, Joar; Thorborg, Kristian; Serner, Andreas; Bjørkheim, André; Rolstad, Linn E; Hölmich, Per; Bahr, Roald; Andersen, Thor Einar

    2017-11-01

    The FIFA 11+ was developed as a complete warm-up program to prevent injuries in soccer players. Although reduced hip adduction strength is associated with groin injuries, none of the exercises included in the FIFA 11+ seem to specifically target hip adduction strength. To investigate the effect on eccentric hip adduction strength of the FIFA 11+ warm-up program with or without the Copenhagen adduction exercise. Randomized controlled trial; Level of evidence, 1. We recruited 45 eligible players from 2 U19 elite male soccer teams. Players were randomized into 2 groups; 1 group carried out the standard FIFA 11+ program, while the other carried out the FIFA 11+ but replaced the Nordic hamstring exercise with the Copenhagen adduction exercise. Both groups performed the intervention 3 times weekly for 8 weeks. Players completed eccentric strength and sprint testing before and after the intervention. Per-protocol analyses were performed, and 12 players were excluded due to low compliance (<67% of sessions completed). The main outcome was eccentric hip adduction strength (N·m/kg). Between-group analyses revealed a significantly greater increase in eccentric hip adduction strength of 0.29 Nm/kg (8.9%; P = .01) in favor of the group performing the Copenhagen adduction exercise, whereas no within-group change was noted in the group that used the standard FIFA 11+ program (-0.02 N·m/kg [-0.7%]; P = .69). Including the Copenhagen adduction exercise in the FIFA 11+ program increases eccentric hip adduction strength, while the standard FIFA 11+ program does not. Registration: Registration: ISRCTN13731446 (International Standard Randomised Controlled Trial Number registry).

  18. Right versus left radial artery access for coronary procedures: an international collaborative systematic review and meta-analysis including 5 randomized trials and 3210 patients.

    Science.gov (United States)

    Biondi-Zoccai, Giuseppe; Sciahbasi, Alessandro; Bodí, Vicente; Fernández-Portales, Javier; Kanei, Yumiko; Romagnoli, Enrico; Agostoni, Pierfrancesco; Sangiorgi, Giuseppe; Lotrionte, Marzia; Modena, Maria Grazia

    2013-07-01

    Radial artery access is a mainstay in the diagnosis and treatment of coronary artery disease. However, there is uncertainty on the comparison of right versus left radial access for coronary procedures. We thus undertook a systematic review and meta-analysis comparing right versus left radial access for coronary diagnostic and interventional procedures. Pertinent studies were searched in CENTRAL, Google Scholar, MEDLINE/PubMed, and Scopus, together with international conference proceedings. Randomized trials comparing right versus left radial (or ulnar) access for coronary diagnostic or interventional procedures were included. Risk ratios (RR) and weighted mean differences (WMD) were computed to generate point estimates (95% confidence intervals). A total of 5 trials (3210 patients) were included. No overall significant differences were found comparing right versus left radial access in terms of procedural time (WMD=0.99 [-0.53; 2.51]min, p=0.20), contrast use (WMD=1.71 [-1.32; 4.74]mL, p=0.27), fluoroscopy time (WMD=-35.79 [-3.54; 75.12]s, p=0.07) or any major complication (RR=2.00 [0.75; 5.31], p=0.49). However, right radial access was fraught with a significantly higher risk of failure leading to cross-over to femoral access (RR=1.65 [1.18; 2.30], p=0.003) in comparison to left radial access. Right and left radial accesses appear largely similar in their overall procedural and clinical performance during transradial diagnostic or interventional procedures. Nonetheless, left radial access can be recommended especially during the learning curve phase to reduce femoral cross-overs. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  19. Comparison of treatment effect estimates for pharmacological randomized controlled trials enrolling older adults only and those including adults: a meta-epidemiological study.

    Directory of Open Access Journals (Sweden)

    Valérie Seegers

    Full Text Available CONTEXT: Older adults are underrepresented in clinical research. To assess therapeutic efficacy in older patients, some randomized controlled trials (RCTs include older adults only. OBJECTIVE: To compare treatment effects between RCTs including older adults only (elderly RCTs and RCTs including all adults (adult RCTs by a meta-epidemiological approach. METHODS: All systematic reviews published in the Cochrane Library (Issue 4, 2011 were screened. Eligible studies were meta-analyses of binary outcomes of pharmacologic treatment including at least one elderly RCT and at least one adult RCT. For each meta-analysis, we compared summary odds ratios for elderly RCTs and adult RCTs by calculating a ratio of odds ratios (ROR. A summary ROR was estimated across all meta-analyses. RESULTS: We selected 55 meta-analyses including 524 RCTs (17% elderly RCTs. The treatment effects differed beyond that expected by chance for 7 (13% meta-analyses, showing more favourable treatment effects in elderly RCTs in 5 cases and in adult RCTs in 2 cases. The summary ROR was 0.91 (95% CI, 0.77-1.08, p = 0.28, with substantial heterogeneity (I(2 = 51% and τ(2 = 0.14. Sensitivity and subgroup analyses by type-of-age RCT (elderly RCTs vs RCTs excluding older adults and vs RCTs of mixed-age adults, type of outcome (mortality or other and type of comparator (placebo or active drug yielded similar results. CONCLUSIONS: The efficacy of pharmacologic treatments did not significantly differ, on average, between RCTs including older adults only and RCTs of all adults. However, clinically important discrepancies may occur and should be considered when generalizing evidence from all adults to older adults.

  20. A water-based training program that include perturbation exercises to improve stepping responses in older adults: study protocol for a randomized controlled cross-over trial

    Directory of Open Access Journals (Sweden)

    Tsedek Irit

    2008-08-01

    Full Text Available Abstract Background Gait and balance impairments may increase the risk of falls, the leading cause of accidental death in the elderly population. Fall-related injuries constitute a serious public health problem associated with high costs for society as well as human suffering. A rapid step is the most important protective postural strategy, acting to recover equilibrium and prevent a fall from initiating. It can arise from large perturbations, but also frequently as a consequence of volitional movements. We propose to use a novel water-based training program which includes specific perturbation exercises that will target the stepping responses that could potentially have a profound effect in reducing risk of falling. We describe the water-based balance training program and a study protocol to evaluate its efficacy (Trial registration number #NCT00708136. Methods/Design The proposed water-based training program involves use of unpredictable, multi-directional perturbations in a group setting to evoke compensatory and volitional stepping responses. Perturbations are made by pushing slightly the subjects and by water turbulence, in 24 training sessions conducted over 12 weeks. Concurrent cognitive tasks during movement tasks are included. Principles of physical training and exercise including awareness, continuity, motivation, overload, periodicity, progression and specificity were used in the development of this novel program. Specific goals are to increase the speed of stepping responses and improve the postural control mechanism and physical functioning. A prospective, randomized, cross-over trial with concealed allocation, assessor blinding and intention-to-treat analysis will be performed to evaluate the efficacy of the water-based training program. A total of 36 community-dwelling adults (age 65–88 with no recent history of instability or falling will be assigned to either the perturbation-based training or a control group (no training

  1. A water-based training program that include perturbation exercises to improve stepping responses in older adults: study protocol for a randomized controlled cross-over trial.

    Science.gov (United States)

    Melzer, Itshak; Elbar, Ori; Tsedek, Irit; Oddsson, Lars Ie

    2008-08-17

    Gait and balance impairments may increase the risk of falls, the leading cause of accidental death in the elderly population. Fall-related injuries constitute a serious public health problem associated with high costs for society as well as human suffering. A rapid step is the most important protective postural strategy, acting to recover equilibrium and prevent a fall from initiating. It can arise from large perturbations, but also frequently as a consequence of volitional movements. We propose to use a novel water-based training program which includes specific perturbation exercises that will target the stepping responses that could potentially have a profound effect in reducing risk of falling. We describe the water-based balance training program and a study protocol to evaluate its efficacy (Trial registration number #NCT00708136). The proposed water-based training program involves use of unpredictable, multi-directional perturbations in a group setting to evoke compensatory and volitional stepping responses. Perturbations are made by pushing slightly the subjects and by water turbulence, in 24 training sessions conducted over 12 weeks. Concurrent cognitive tasks during movement tasks are included. Principles of physical training and exercise including awareness, continuity, motivation, overload, periodicity, progression and specificity were used in the development of this novel program. Specific goals are to increase the speed of stepping responses and improve the postural control mechanism and physical functioning. A prospective, randomized, cross-over trial with concealed allocation, assessor blinding and intention-to-treat analysis will be performed to evaluate the efficacy of the water-based training program. A total of 36 community-dwelling adults (age 65-88) with no recent history of instability or falling will be assigned to either the perturbation-based training or a control group (no training). Voluntary step reaction times and postural stability

  2. A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.

    Science.gov (United States)

    Guo, J J; Tang, N; Yang, H L; Tang, T S

    2010-07-01

    We compared the outcome of closed intramedullary nailing with minimally invasive plate osteosynthesis using a percutaneous locked compression plate in patients with a distal metaphyseal fracture in a prospective study. A total of 85 patients were randomised to operative stabilisation either by a closed intramedullary nail (44) or by minimally invasive osteosynthesis with a compression plate (41). Pre-operative variables included the patients' age and the side and pattern of the fracture. Peri-operative variables were the operating time and the radiation time. Postoperative variables were wound problems, the time to union of the fracture, the functional American Orthopaedic Foot and Ankle surgery score and removal of hardware. We found no significant difference in the pre-operative variables or in the time to union in the two groups. However, the mean radiation time and operating time were significantly longer in the locked compression plate group (3.0 vs 2.12 minutes, p Foot and Ankle surgery scores, although the differences were not statistically significant (p = 0.234, p = 0.157, p = 0.897, p = 0.177 respectively). Three (6.8%) patients in the intramedullary nailing group and six (14.6%) in the locked compression plate group showed delayed wound healing, and 37 (84.1%) in the former group and 38 (92.7%) in the latter group expressed a wish to have the implant removed. We conclude that both closed intramedullary nailing and a percutaneous locked compression plate can be used safely to treat Orthopaedic Trauma Association type-43A distal metaphyseal fractures of the tibia. However, closed intramedullary nailing has the advantage of a shorter operating and radiation time and easier removal of the implant. We therefore prefer closed intramedullary nailing for patients with these fractures.

  3. Effects of standard training in the use of closed-circuit televisions in visually impaired adults: design of a training protocol and a randomized controlled trial

    Science.gov (United States)

    2010-01-01

    Background Reading problems are frequently reported by visually impaired persons. A closed-circuit television (CCTV) can be helpful to maintain reading ability, however, it is difficult to learn how to use this device. In the Netherlands, an evidence-based rehabilitation program in the use of CCTVs was lacking. Therefore, a standard training protocol needed to be developed and tested in a randomized controlled trial (RCT) to provide an evidence-based training program in the use of this device. Methods/Design To develop a standard training program, information was collected by studying literature, observing training in the use of CCTVs, discussing the content of the training program with professionals and organizing focus and discussion groups. The effectiveness of the program was evaluated in an RCT, to obtain an evidence-based training program. Dutch patients (n = 122) were randomized into a treatment group: normal instructions from the supplier combined with training in the use of CCTVs, or into a control group: instructions from the supplier only. The effect of the training program was evaluated in terms of: change in reading ability (reading speed and reading comprehension), patients' skills to operate the CCTV, perceived (vision-related) quality of life and tasks performed in daily living. Discussion The development of the CCTV training protocol and the design of the RCT in the present study may serve as an example to obtain an evidence-based training program. The training program was adjusted to the needs and learning abilities of individual patients, however, for scientific reasons it might have been preferable to standardize the protocol further, in order to gain more comparable results. Trial registration http://www.trialregister.nl, identifier: NTR1031 PMID:20219120

  4. Prevention of diabetes in overweight/obese children through a family based intervention program including supervised exercise (PREDIKID project): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Arenaza, Lide; Medrano, María; Amasene, María; Rodríguez-Vigil, Beatriz; Díez, Ignacio; Graña, Manuel; Tobalina, Ignacio; Maiz, Edurne; Arteche, Edurne; Larrarte, Eider; Huybrechts, Inge; Davis, Catherine L; Ruiz, Jonatan R; Ortega, Francisco B; Margareto, Javier; Labayen, Idoia

    2017-08-10

    The global pandemic of obesity has led to an increased risk for prediabetes and type-2 diabetes (T2D). The aims of the current project are: (1) to evaluate the effect of a 22-week family based intervention program, including supervised exercise, on insulin resistance syndrome (IRS) risk in children with a high risk of developing T2D and (2) to identify the profile of microRNA in circulating exosomes and in peripheral blood mononuclear cells in children with a high risk of developing T2D and its response to a multidisciplinary intervention program including exercise. A total of 84 children, aged 8-12 years, with a high risk of T2D will be included and randomly assigned to control (N = 42) or intervention (N = 42) groups. The control group will receive a family based lifestyle education and psycho-educational program (2 days/month), while the intervention group will attend the same lifestyle education and psycho-educational program plus the exercise program (3 days/week, 90 min per session including warm-up, moderate to vigorous aerobic activities, and strength exercises). The following measurements will be evaluated at baseline prior to randomization and after the intervention: fasting insulin, glucose and hemoglobin A1c; body composition (dual-energy X-ray absorptiometry); ectopic fat (magnetic resonance imaging); microRNA expression in circulating exosomes and in peripheral blood mononuclear cells (MiSeq; Illumina); cardiorespiratory fitness (cardiopulmonary exercise testing); dietary habits and physical activity (accelerometry). Prevention and identification of children with a high risk of developing T2D could help to improve their cardiovascular health and to reduce the comorbidities associated with obesity. ClinicalTrials.gov, ID: NCT03027726 . Registered on 16 January 2017.

  5. Cost-effectiveness of collaborative care including PST and an antidepressant treatment algorithm for the treatment of major depressive disorder in primary care; a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Beekman Aartjan TF

    2007-03-01

    Full Text Available Abstract Background Depressive disorder is currently one of the most burdensome disorders worldwide. Evidence-based treatments for depressive disorder are already available, but these are used insufficiently, and with less positive results than possible. Earlier research in the USA has shown good results in the treatment of depressive disorder based on a collaborative care approach with Problem Solving Treatment and an antidepressant treatment algorithm, and research in the UK has also shown good results with Problem Solving Treatment. These treatment strategies may also work very well in the Netherlands too, even though health care systems differ between countries. Methods/design This study is a two-armed randomised clinical trial, with randomization on patient-level. The aim of the trial is to evaluate the treatment of depressive disorder in primary care in the Netherlands by means of an adapted collaborative care framework, including contracting and adherence-improving strategies, combined with Problem Solving Treatment and antidepressant medication according to a treatment algorithm. Forty general practices will be randomised to either the intervention group or the control group. Included will be patients who are diagnosed with moderate to severe depression, based on DSM-IV criteria, and stratified according to comorbid chronic physical illness. Patients in the intervention group will receive treatment based on the collaborative care approach, and patients in the control group will receive care as usual. Baseline measurements and follow up measures (3, 6, 9 and 12 months are assessed using questionnaires and an interview. The primary outcome measure is severity of depressive symptoms, according to the PHQ9. Secondary outcome measures are remission as measured with the PHQ9 and the IDS-SR, and cost-effectiveness measured with the TiC-P, the EQ-5D and the SF-36. Discussion In this study, an American model to enhance care for patients with a

  6. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... care providers might be part of your treatment team. They will monitor your health closely. You may ...

  7. Real-world cure rates for hepatitis C virus treatments that include simeprevir and/or sofosbuvir are comparable to clinical trial results.

    Science.gov (United States)

    Bichoupan, Kian; Tandon, Neeta; Crismale, James F; Hartman, Joshua; Del Bello, David; Patel, Neal; Chekuri, Sweta; Harty, Alyson; Ng, Michel; Sigel, Keith M; Bansal, Meena B; Grewal, Priya; Chang, Charissa Y; Leong, Jennifer; Im, Gene Y; Liu, Lawrence U; Odin, Joseph A; Bach, Nancy; Friedman, Scott L; Schiano, Thomas D; Perumalswami, Ponni V; Dieterich, Douglas T; Branch, Andrea D

    2017-11-12

    To assess the real-world effectiveness and cost of simeprevir (SMV), and/or sofosbuvir (SOF)-based therapy for chronic hepatitis C virus (HCV) infection. The real-world performance of patients treated with SMV/SOF ± ribavirin (RBV), SOF/RBV, and SOF/RBV with pegylated-interferon (PEG) were analyzed in a consecutive series of 508 patients with chronic HCV infection treated at a single academic medical center. Patients with genotypes 1 through 4 were included. Rates of sustained virological response - the absence of a detectable serum HCV RNA 12 wk after the end of treatment [sustained virological response (SVR) 12] - were calculated on an intention-to-treat basis. Costs were calculated from the payer's perspective using Medicare/Medicaid fees and Redbook Wholesale Acquisition Costs. Patient-related factors associated with SVR12 were identified using multivariable logistic regression. SVR12 rates were as follows: 86% (95%CI: 80%-91%) among 178 patients on SMV/SOF ± RBV; 62% (95%CI: 55%-68%) among 234 patients on SOF/RBV; and 78% (95%CI: 68%-86%) among 96 patients on SOF/PEG/RBV. Mean costs-per-SVR12 were $174442 (standard deviation: ± $18588) for SMV/SOF ± RBV; $223003 (± $77946) for SOF/RBV; and $126496 (± $31052) for SOF/PEG/RBV. Among patients on SMV/SOF ± RBV, SVR12 was less likely in patients previously treated with a protease inhibitor [odds ratio (OR): 0.20, 95%CI: 0.06-0.56]. Higher bilirubin (OR: 0.47, 95%CI: 0.30-0.69) reduced the likelihood of SVR12 among patients on SOF/RBV, while FIB-4 score ≥ 3.25 reduced the likelihood of SVR12 (OR: 0.18, 95%CI: 0.05-0.59) among those on SOF/PEG/RBV. SVR12 rates for SMV and/or SOF-based regimens in a diverse real-world population are comparable to those in clinical trials. Treatment failure accounts for 27% of costs.

  8. Closed-loop control better than open-loop control of profofol TCI guided by BIS: a randomized, controlled, multicenter clinical trial to evaluate the CONCERT-CL closed-loop system.

    Science.gov (United States)

    Liu, Yu; Li, Min; Yang, Dong; Zhang, Xuena; Wu, Anshi; Yao, Shanglong; Xue, Zhanggang; Yue, Yun

    2015-01-01

    The CONCERT-CL closed-loop infusion system designed by VERYARK Technology Co., Ltd. (Guangxi, China) is an innovation using TCI combined with closed-loop controlled intravenous anesthesia under the guide of BIS. In this study we performed a randomized, controlled, multicenter study to compare closed-loop control and open-loop control of propofol by using the CONCERT-CL closed-loop infusion system. 180 surgical patients from three medical centers undergone TCI intravenous anesthesia with propofol and remifentanil were randomly assigned to propofol closed-loop group and propofol opened-loop groups. Primary outcome was global score (GS, GS = (MDAPE+Wobble)/% of time of bispectral index (BIS) 40-60). Secondary outcomes were doses of the anesthetics and emergence time from anesthesia, such as, time to tracheal extubation. There were 89 and 86 patients in the closed-loop and opened-loop groups, respectively. GS in the closed-loop groups (22.21±8.50) were lower than that in the opened-loop group (27.19±15.26) (p=0.009). The higher proportion of time of BIS between 40 and 60 was also observed in the closed-loop group (84.11±9.50%), while that was 79.92±13.17% in the opened-loop group, (p=0.016). No significant differences in propofol dose and time of tracheal extubation were observed. The frequency of propofol regulation in the closed-loop group (31.55±9.46 times/hr) was obverse higher than that in the opened-loop group (6.84±6.21 times/hr) (p=0.000). The CONCERT-CL closed-loop infusion system can automatically regulate the TCI of propofol, maintain the BIS value in an adequate range and reduce the workload of anesthesiologists better than open-loop system. ChiCTR ChiCTR-OOR-14005551.

  9. The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years.

    Science.gov (United States)

    Keene, David J; Mistry, Dipesh; Nam, Julian; Tutton, Elizabeth; Handley, Robert; Morgan, Lesley; Roberts, Emma; Gray, Bridget; Briggs, Andrew; Lall, Ranjit; Chesser, Tim Js; Pallister, Ian; Lamb, Sarah E; Willett, Keith

    2016-10-01

    Close contact casting (CCC) may offer an alternative to open reduction and internal fixation (ORIF) surgery for unstable ankle fractures in older adults. We aimed to (1) determine if CCC for unstable ankle fractures in adults aged over 60 years resulted in equivalent clinical outcome compared with ORIF, (2) estimate cost-effectiveness to the NHS and society and (3) explore participant experiences. A pragmatic, multicentre, equivalence randomised controlled trial incorporating health economic evaluation and qualitative study. Trauma and orthopaedic departments of 24 NHS hospitals. Adults aged over 60 years with unstable ankle fracture. Those with serious limb or concomitant disease or substantial cognitive impairment were excluded. CCC was conducted under anaesthetic in theatre by surgeons who attended training. ORIF was as per local practice. Participants were randomised in 1 : 1 allocation via remote telephone randomisation. Sequence generation was by random block size, with stratification by centre and fracture pattern. Follow-up was conducted at 6 weeks and, by blinded outcome assessors, at 6 months after randomisation. The primary outcome was the Olerud-Molander Ankle Score (OMAS), a patient-reported assessment of ankle function, at 6 months. Secondary outcomes were quality of life (as measured by the European Quality of Life 5-Dimensions, Short Form questionnaire-12 items), pain, ankle range of motion and mobility (as measured by the timed up and go test), patient satisfaction and radiological measures. In accordance with equivalence trial US Food and Drug Administration guidance, primary analysis was per protocol. We recruited 620 participants, 95 from the pilot and 525 from the multicentre phase, between June 2010 and November 2013. The majority of participants, 579 out of 620 (93%), received the allocated treatment; 52 out of 275 (19%) who received CCC later converted to ORIF because of loss of fracture reduction. CCC resulted in equivalent ankle

  10. Clinical Trials

    Medline Plus

    Full Text Available ... proven to work and you're in the group getting it, you might be among the first to benefit. If you're in a clinical trial and ... health closely. In late-phase clinical trials, possible benefits or ... trials have large groups of similar patients taking the same treatment the ...

  11. The effects of a cycling warm-up including high-intensity heavy-resistance conditioning contractions on subsequent 4 km time trial performance.

    Science.gov (United States)

    Chorley, Alan; Lamb, Kevin L

    2017-03-25

    Prior exercise has been shown to improve subsequent performance via different mechanisms. Sport-specific conditioning contractions can be used to exploit the 'post-activation potentiation' (PAP) phenomenon to enhance performance although this has rarely been investigated in short endurance events. The aim of this study was to compare a cycling warm-up with PAP-inducing conditioning contractions (CW) with a moderate intensity warm-up (MW) on performance and physiological outcomes of 4 km time trial. Ten well-trained male endurance cyclists (V[Combining Dot Above]O2max 65.3 ± 5.6 ml·kg·min) performed two 4 km cycling time trials following a 5-minute recovery after a warm-up at 60% of V[Combining Dot Above]O2max for 6.5-minutes (MW), and a warm-up with conditioning contractions (CW) consisting of 5 minutes at 60% of V[Combining Dot Above]O2max then 3 x 10-seconds at 70% of peak power interspersed with 30-seconds recovery. Blood lactate concentrations were measured before and after time trial. Expired gases were analysed along with time, power output (PO), and peak forces over each 500 m split. Following CW, mean completion time was reduced (1.7 ± 3.5 s p > 0.05), PO increased (5.1 ± 10.5 W p > 0.05) as did peak force per pedal stroke (5.7 ± 11 N p > 0.05) when compared to MW. V[Combining Dot Above]O2 increased (1.4 ± 1.6 ml·kg·min p cycling but work and recovery durations should be optimised for each athlete.

  12. Clinical Trials

    Medline Plus

    Full Text Available ... criteria differ from trial to trial. They include factors such as a patient's age and gender, the ... bias. "Bias" means that human choices or other factors not related to the protocol affect the trial's ...

  13. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  14. Implementation of the 2013 American College of Cardiology/American Heart Association Blood Cholesterol Guideline Including Data From the Improved Reduction of Outcomes: Vytorin Efficacy International Trial

    Science.gov (United States)

    Ziaeian, Boback; Dinkler, John; Watson, Karol

    2015-01-01

    Atherosclerotic cardiovascular disease (ASCVD) is a leading cause of morbidity and mortality in developed countries. The management of blood cholesterol through use of 3-hydroxy-3-methyl-glutaryl-CoA (HMG-CoA) reductase inhibitors (statins) in at-risk patients is a pillar of medical therapy for the primary and secondary prevention of cardiovascular disease. The recent 2013 American College of Cardiology/American Heart Association guideline on managing blood cholesterol provides an important framework for the effective implementation of risk-reduction strategies. The guideline identifies four cohorts of patients with proven benefits from statin therapy and streamlines the dosing and monitoring recommendations based on evidence from published, randomized controlled trials. Primary care physicians and cardiologists play key roles in identifying populations at elevated ASCVD risk. In providing a practical management overview of the current blood cholesterol guideline, we facilitate more informed discussions on treatment options between healthcare providers and their patients. PMID:26198559

  15. Te Ira Tangata: A Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in Maori who present to hospital after self harm

    Directory of Open Access Journals (Sweden)

    Wikiriwhi Karen

    2011-05-01

    Full Text Available Abstract Background Maori, the indigenous people of New Zealand, who present to hospital after intentionally harming themselves, do so at a higher rate than non-Maori. There have been no previous treatment trials in Maori who self harm and previous reviews of interventions in other populations have been inconclusive as existing trials have been under powered and done on unrepresentative populations. These reviews have however indicated that problem solving therapy and sending regular postcards after the self harm attempt may be an effective treatment. There is also a small literature on sense of belonging in self harm and the importance of culture. This protocol describes a pragmatic trial of a package of measures which include problem solving therapy, postcards, patient support, cultural assessment, improved access to primary care and a risk management strategy in Maori who present to hospital after self harm using a novel design. Methods We propose to use a double consent Zelen design where participants are randomised prior to giving consent to enrol a representative cohort of patients. The main outcome will be the number of Maori scoring below nine on the Beck Hopelessness Scale. Secondary outcomes will be hospital repetition at one year; self reported self harm; anxiety; depression; quality of life; social function; and hospital use at three months and one year. Discussion A strength of the study is that it is a pragmatic trial which aims to recruit Maori using a Maori clinical team and protocol. It does not exclude people if English is not their first language. A potential limitation is the analysis of the results which is complex and may underestimate any effect if a large number of people refuse their consent in the group randomised to problem solving therapy as they will effectively cross over to the treatment as usual group. This study is the first randomised control trial to explicitly use cultural assessment and management. Trial

  16. Intralesional immunotherapy with tuberculin purified protein derivative (PPD) in recalcitrant wart: A randomized, placebo-controlled, double-blind clinical trial including an extra group of candidates for cryotherapy.

    Science.gov (United States)

    Amirnia, Mehdi; Khodaeiani, Effat; Fouladi, Daniel F; Masoudnia, Sima

    2016-01-01

    Due to paucity of randomized clinical trials, intralesional immunotherapy has not been yet accepted as a standard therapeutic method. To examine the efficacy and safety of intralesional immunotherapy with tuberculin purified protein derivative (PPD) for treating recalcitrant wart. In this randomized, placebo-controlled, double-blind clinical trial, a total of 69 patients with recalcitrant warts received either intralesional PPD antigen (n = 35) or intralesional saline (n = 34) for six times at 2-week intervals. A third group of candidates for cryotherapy (n = 33) was also included. The decrease in lesion size (good: complete response, intermediate: 50-99% improvement, poor: cryotherapy patients, respectively (PPD versus placebo: p cryotherapy: p cryotherapy groups, respectively (p > 0.05). Intralesional immunotherapy with PPD antigen is highly effective and safe for treating recalcitrant warts. IRCT201407089844N3 in the Iranian Registry of Clinical Trials (IRCT).

  17. Analysis of virological efficacy in trials of antiretroviral regimens: drawbacks of not including viral load measurements after premature discontinuation of therapy

    DEFF Research Database (Denmark)

    Kirk, Ole; Pedersen, Court; Law, Matthew

    2002-01-01

    SIDA) starting their first HAART regimen. METHODS: Two classifications of defining virological response 48 weeks after starting the therapy to be evaluated were compared: 1) only patients remaining on the therapy and having a plasma viral load (pVL) below a given cut-off level at week 48 were classified...... as responders (ITT/s=f); and 2) patients with a pVL below a given cut-off at week 48 whether they remained on initial assigned therapy or switched therapy were responders (ITT/s incl). In both analyses, patients with missing data at week 48 were classified as failures (i.e., non-responders). RESULTS: According....../s=f, and 41-72% according to ITT/s incl. Among those who discontinued the therapy to be evaluated in these two trials, 13-45% (cohort: 39-74%) subsequently experienced a virological response at week 48. The subsequent response rates were associated with the reason for discontinuation (toxicity versus...

  18. Short- and medium-term efficacy of a Web-based computer-tailored nutrition education intervention for adults including cognitive and environmental feedback: randomized controlled trial.

    Science.gov (United States)

    Springvloet, Linda; Lechner, Lilian; de Vries, Hein; Candel, Math J J M; Oenema, Anke

    2015-01-19

    Web-based, computer-tailored nutrition education interventions can be effective in modifying self-reported dietary behaviors. Traditional computer-tailored programs primarily targeted individual cognitions (knowledge, awareness, attitude, self-efficacy). Tailoring on additional variables such as self-regulation processes and environmental-level factors (the home food environment arrangement and perception of availability and prices of healthy food products in supermarkets) may improve efficacy and effect sizes (ES) of Web-based computer-tailored nutrition education interventions. This study evaluated the short- and medium-term efficacy and educational differences in efficacy of a cognitive and environmental feedback version of a Web-based computer-tailored nutrition education intervention on self-reported fruit, vegetable, high-energy snack, and saturated fat intake compared to generic nutrition information in the total sample and among participants who did not comply with dietary guidelines (the risk groups). A randomized controlled trial was conducted with a basic (tailored intervention targeting individual cognition and self-regulation processes; n=456), plus (basic intervention additionally targeting environmental-level factors; n=459), and control (generic nutrition information; n=434) group. Participants were recruited from the general population and randomly assigned to a study group. Self-reported fruit, vegetable, high-energy snack, and saturated fat intake were assessed at baseline and at 1- (T1) and 4-months (T2) postintervention using online questionnaires. Linear mixed model analyses examined group differences in change over time. Educational differences were examined with group×time×education interaction terms. In the total sample, the basic (T1: ES=-0.30; T2: ES=-0.18) and plus intervention groups (T1: ES=-0.29; T2: ES=-0.27) had larger decreases in high-energy snack intake than the control group. The basic version resulted in a larger decrease in

  19. Nonoxynol-9 spermicide for prevention of vaginally acquired HIV and other sexually transmitted infections: systematic review and meta-analysis of randomised controlled trials including more than 5000 women.

    Science.gov (United States)

    Wilkinson, David; Tholandi, Maya; Ramjee, Gita; Rutherford, George W

    2002-10-01

    We aimed to determine the effectiveness of the vaginally administered spermicide nonoxynol-9 (N-9) among women for the prevention of HIV and other sexually transmitted infections (STIs). We did a systematic review of randomised controlled trials. Nine such trials including 5096 women, predominantly sex workers, comparing N-9 with placebo or no treatment, were included. Primary outcomes were new HIV infection, new episodes of various STIs, and genital lesions. Five trials included HIV and nine included STI outcomes, and all but one (2% of the data) contributed to the meta-analysis. Overall, relative risks of HIV infection (1.12, 95% confidence interval 0.88-1.42), gonorrhoea (0.91, 0.67-1.24), chlamydia (0.88, 0.77-1.01), cervical infection (1.01, 0.84-1.22), trichomoniasis (0.84, 0.69-1.02), bacterial vaginosis (0.88, 0.74-1.04) and candidiasis (0.97, 0.84-1.12) were not significantly different in the N-9 and placebo or no treatment groups. Genital lesions were more common in the N-9 group (1.18, 1.02-1.36). Our review has found no statistically significant reduction in risk of HIV and STIs, and the confidence intervals indicate that any protection that may exist is likely to be very small. There is some evidence of harm through genital lesions. N-9 cannot be recommended for HIV and STI prevention.

  20. A randomized, controlled trial of a multifaceted intervention including alcohol-based hand sanitizer and hand-hygiene education to reduce illness transmission in the home.

    Science.gov (United States)

    Sandora, Thomas J; Taveras, Elsie M; Shih, Mei-Chiung; Resnick, Elissa A; Lee, Grace M; Ross-Degnan, Dennis; Goldmann, Donald A

    2005-09-01

    Good hand hygiene may reduce the spread of infections in families with children who are in out-of-home child care. Alcohol-based hand sanitizers rapidly kill viruses that are commonly associated with respiratory and gastrointestinal (GI) infections. The objective of this study was to determine whether a multifactorial campaign centered on increasing alcohol-based hand sanitizer use and hand-hygiene education reduces illness transmission in the home. A cluster randomized, controlled trial was conducted of homes of 292 families with children who were enrolled in out-of-home child care in 26 child care centers. Eligible families had > or =1 child who was 6 months to 5 years of age and in child care for > or =10 hours/week. Intervention families received a supply of hand sanitizer and biweekly hand-hygiene educational materials for 5 months; control families received only materials promoting good nutrition. Primary caregivers were phoned biweekly and reported respiratory and GI illnesses in family members. Respiratory and GI-illness-transmission rates (measured as secondary illnesses per susceptible person-month) were compared between groups, adjusting for demographic variables, hand-hygiene practices, and previous experience using hand sanitizers. Baseline demographics were similar in the 2 groups. A total of 1802 respiratory illnesses occurred during the study; 443 (25%) were secondary illnesses. A total of 252 GI illnesses occurred during the study; 28 (11%) were secondary illnesses. The secondary GI-illness rate was significantly lower in intervention families compared with control families (incidence rate ratio [IRR]: 0.41; 95% confidence interval [CI]: 0.19-0.90). The overall rate of secondary respiratory illness was not significantly different between groups (IRR: 0.97; 95% CI: 0.72-1.30). However, families with higher sanitizer usage had a marginally lower secondary respiratory illness rate than those with less usage (IRR: 0.81; 95% CI: 0.65-1.09). A

  1. Efficacy and tolerability of renzapride in irritable bowel syndrome: a meta-analysis of randomized, controlled clinical trials including 2528 patients.

    Science.gov (United States)

    Mozaffari, Shilan; Nikfar, Shekoufeh; Abdollahi, Mohammad

    2014-02-24

    By targeting different subtypes of 5-hydroxytryptamine (5HT) receptors in the gastrointestinal (GI) tract, several drugs have been introduced for the management of irritable bowel syndrome (IBS). Renzapride is a full agonist for 5HT4 receptor and an antagonist to 5HT2b and 5HT3 receptors which is thought a promising therapeutic agent for constipation predominant IBS (C-IBS) patients due to its accelerating effect on the GI tract. In this meta-analysis, our aim was to evaluate the efficacy and tolerability of renzapride in the management of IBS. A search was done from 1992 to February 2013 for placebo-controlled trials that investigated the efficacy of renzapride in IBS. Relative risk (RR) for clinical efficacy in IBS patients treated for 5 weeks or less comparing renzapride to placebo was 1.07 (95% CI = 0.89-1.29, p = 0.38). This value for IBS patients treated for more than 5 weeks was 1.04 (95% CI = 0.78-1.239, p = 0.77). The RR for clinical efficacy in IBS patients treated with renzapride (4 mg) for 5 weeks or less and more than 5 weeks in comparison to placebo was 1.2 (95% CI = 0.97-1.48, p = 0.1) and 1.16 (95% CI = 0.98-1.37, p = 0.08), respectively, which were statistically non-significant but clinically important. The analysis of tolerability demonstrated that amongst different reported adverse effects, renzapride caused diarrhea more than placebo (RR = 1.61 with a 95% CI = 1.16-2.24, p = 0.004). The RR for withdrawals from renzapride compared to placebo was 1.58 (95% CI = 1.26-2.07, p = 0.0007). Renzapride is not superior to placebo in relieving IBS symptoms and causes significant incidences of diarrhea and drop-outs due to adverse effects in treated patients vs. placebo. Thus, this medicine might be a cost burden to patients without providing good effectiveness.

  2. Study protocol of a pragmatic, randomised controlled pilot trial: clinical effectiveness on smoking cessation of traditional and complementary medicine interventions, including acupuncture and aromatherapy, in combination with nicotine replacement therapy.

    Science.gov (United States)

    Jang, Soobin; Park, Sunju; Jang, Bo-Hyoung; Park, Yu Lee; Lee, Ju Ah; Cho, Chung-Sik; Go, Ho-Yeon; Shin, Yong Cheol; Ko, Seong-Gyu

    2017-06-02

    participants in detail. As an ethical clinical trial, the control group will also be given conventional cessation treatments, including NRT and counselling. Participants will be screened and provided with a registration number to protect their personal information. Informed consent will be obtained from the participants prior to enrolling them in the trial. Participants will be allowed to withdraw at anytime without penalty. ClinicalTrials.gov (NCT02768025); pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  3. Can municipality-based post-discharge follow-up visits including a general practitioner reduce early readmission among the fragile elderly (65+ years old)? A randomized controlled trial

    OpenAIRE

    Thygesen, Lau Caspar; Fokdal, Sara; Gj?rup, Thomas; Taylor, Rod S.; Zwisler, Ann-Dorthe

    2015-01-01

    Objective. To evaluate how municipality-based post-discharge follow-up visits including a general practitioner and municipal nurse affect early readmission among high-risk older people discharged from a hospital department of internal medicine. Design and setting. Centrally randomized single-centre pragmatic controlled trial comparing intervention and usual care with investigator-blinded outcome assessment. Intervention. The intervention was home visits with a general practitioner and municip...

  4. Clinical Trials

    Medline Plus

    Full Text Available ... including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored ... risks. Other examples of clinical trials that test principles or strategies include studies that explore whether surgery ...

  5. Clinical Trials

    Medline Plus

    Full Text Available ... sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, ... and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually ...

  6. Clinical Trials

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    Full Text Available ... care providers might be part of your treatment team. They will monitor your health closely. You may ... taking part in a clinical trial. Your treatment team also may ask you to do other tasks. ...

  7. Closing Remarks.

    Science.gov (United States)

    Reed

    1996-01-01

    -related conditions were developed. * The only three drugs to date that have been specifically approved for the treatment of AIDS-AZT, DDI, and DDC-were developed under the guidance of the DCT, with Bruce Chabner as Scientific Director. * The first clinical trials conducted with each of these agents-AZT, DDI, and DDC-were performed in the Intramural Program of the DCT. * Concurrently, many of the exciting findings reported by the National Surgical Adjuvant Breast and Bowel Project over the past 10 years (as well as other cooperative groups) were a direct result of the strong support shown by Bruce Chabner during his tenure as Director of the Division of Cancer Treatment. Further, the list above does not include his personal labortory and clinical accomplishments, some of which are: * Development of the principles of use of important antimetabolites, such as methotrexate. * Elucidation of biochemical pathways affected, and the mechanisms of action, of antifols and other antimetabolites. * The conduct of seminal studies in the clinical staging of non-Hodgkin's lymphomas, using laparoscopy as a primary tool. * Important contributions to the development of multiagent regimens in the clinical treatment of lymphomas, and of Hodgkin's disease. * Developed and is editor of the textbook which is considered to be the primary reference source for anticancer chemotherapeutic agents [1]. With all of these accomplishments, his career is long from over. Having just become the Medical Director of the Cancer Center at the Massachusetts General Hospital, Bruce Chabner is uniquely poised to have an even more far-reaching impact on a discipline in which he has played such a strong seminal role. This author was never a postdoctoral fellow in Bruce Chabner's laboratory. However, more than any other single person, he has played a central role in my professional development. I know of many others for whom the same statement would be true. It is a pleasure for me to witness the launching of the second phase

  8. Clinical Trials

    Medline Plus

    Full Text Available ... list of NHLBI-sponsored clinical trials. NIH Clinical Research Studies Search for studies conducted within other Institutes at the NIH, including trials performed on our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

  9. Rationale, study protocol and the cluster randomization process in a controlled trial including 40,000 women investigating the effects of mindfetalness.

    Science.gov (United States)

    Rådestad, Ingela; Akselsson, Anna; Georgsson, Susanne; Lindgren, Helena; Pettersson, Karin; Steineck, Gunnar

    2016-12-01

    Shortening pre-hospital delay may decrease stillbirth rates and rates of babies born with a compromised health. Stillbirth may be preceded by a decrease in fetal movements. Mindfetalness has been developed as a response to the shortcomings of kick-counting for the monitoring of fetal movements by the pregnant woman. We do not know if practicing Mindfetalness may diminish pre-hospital delay. Nor do we know if practicing Mindfetalness may increase or decrease the percentage of women seeking health care for unfounded, from a medical perspective, worry for her fetus' well-being. This article describes the rationale, study protocol and the randomization process for a planned study randomly allocating 40,000 pregnant women to receive, or not receive, proactive information about practicing Mindfetalness. The unit of randomization is 63 antenatal clinics in the Stockholm area. Midwives in the antenatal clinics randomized to Mindfetalness will verbally inform about practicing Mindfetalness, hand out brochures (printed in seven languages) and inform about a website giving information about Mindfetalness. Routine care will continue in the control clinics. All information for the analyses, including the main endpoint of an Apgar score below 7 (e.g., 0-6 with stillbirth giving a score of 0), measured five minutes after birth, will be retrieved from population-based registers. We have randomized 33 antenatal clinics to Mindfetalness and 30 to routine care. In two clinics a pilot study has been performed. One of the clinics randomly allocated to inform about Mindfetalness will not do so (but will be included in the intention-to-treat analysis). In October 2016 we started to recruit women for the main study. The work up to now follows the outlined time schedule. We expect to present the first results concerning the effects of Mindfetalness during 2018. Copyright © 2016 Elsevier B.V. All rights reserved.

  10. Clinical Trials

    Medline Plus

    Full Text Available ... health closely. In late-phase clinical trials, possible benefits or risks of a treatment can be identified earlier than they would be in general medical practice. This is because late-phase trials have large groups of similar patients taking the same treatment ...

  11. Factors influencing the participation of older people in clinical trials - data analysis from the MAVIS trial.

    Science.gov (United States)

    Fearn, P; Avenell, A; McCann, S; Milne, A C; Maclennan, G

    2010-01-01

    Older people are less likely to be included in clinical trials. Little is known about factors influencing older people's decisions about participating in clinical trials. To examine the views of older people about participating in clinical trials. Postal questionnaire to 801 participants who had completed the MAVIS nutrition trial, aged 65 yrs and older. Closed and open questions sought participants' views about factors important to them when deciding to take part in a trial, features of the MAVIS trial they liked and disliked and changes they would suggest. 540 (59% of MAVIS trial participants) returned the questionnaire. The most important reasons reported for taking part in the trial were helping the research team and medical knowledge, and helping other older people. Participants valued good communication with the trial staff and good organisation. Participants reported concerns about swallowing pills and taking a placebo. Participants reported that future participation in trials could be influenced by poor health status. This questionnaire surveyed older participants who had taken part in a randomised controlled trial. It did not elicit the views of people who had withdrawn or never decided to take part in the trial. Older people report altruistic reasons for taking part in trials. Simple trial designs, which minimise demands on participants and maintain good communications should be preferred. Explaining the need for older people, despite poor health, to participate in trials may help the generalisability of clinical trials.

  12. Closed string field theory

    International Nuclear Information System (INIS)

    Strominger, A.

    1987-01-01

    A gauge invariant cubic action describing bosonic closed string field theory is constructed. The gauge symmetries include local spacetime diffeomorphisms. The conventional closed string spectrum and trilinear couplings are reproduced after spontaneous symmetry breaking. The action S is constructed from the usual ''open string'' field of ghost number minus one half. It is given by the associator of the string field product which is non-vanishing because of associativity anomalies. S does not describe open string propagation because open string states associate and can thereby be shifted away. A field theory of closed and open strings can be obtained by adding to S the cubic open string action. (orig.)

  13. Closing remarks

    International Nuclear Information System (INIS)

    Reig, J.

    2007-01-01

    Good afternoon. Before providing the closing remarks on behalf of the NEA, I would like to take this opportunity and make some personal reflections, if you allow me Mr. Chairman. I have had the opportunity to take part in the three workshops on public communication organised by the NEA. In the first one in Paris in 2000, representing my country, Spain, and in the two last ones in Ottawa in 2004 and Tokyo today, on behalf of the NEA. The topics for the three workshops follow a logical order, first the focus was on investing in trust in a time when public communication was becoming a big challenge for the regulators. Second, maintaining and measuring public confidence to assess how credible regulators are in front of the public; and finally here in Tokyo, transparency, which is a basic element to achieve trust and credibility. In my view, a regulatory decision has three main components, it has to be technically sound. legally correct and well communicated. The emphasis in the early years was in the technical matters, till legal issues became a key element to achieve the political acceptance from governments and local authorities. Finally the public communication aspects resulted into a major effort and challenge to achieve social acceptance. (author)

  14. Clinical Trials

    Medline Plus

    Full Text Available ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers ( ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including ... our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments ... sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of ...

  17. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials Are Important Clinical trials are a key research tool for advancing medical knowledge and patient ... that does the study uses the same protocol. Key information in a protocol includes how many patients ...

  18. Closed-loop double-vasopressor automated system vs manual bolus vasopressor to treat hypotension during spinal anaesthesia for caesarean section: a randomised controlled trial.

    Science.gov (United States)

    Sng, B L; Tan, H S; Sia, A T H

    2014-01-01

    Hypotension necessitating vasopressor administration occurs commonly during caesarean section under spinal anaesthesia. We developed a novel vasopressor delivery system that automatically administers phenylephrine or ephedrine based on continuous non-invasive arterial pressure monitoring. A phenylephrine bolus of 50 μg was given at 30-s intervals when systolic blood pressure fell control group used manual boluses of either phenylephrine 100 μg or ephedrine 8 mg, administered at 1-min intervals based on the same thresholds for systolic pressure and heart rate. This randomised, controlled, double-blinded trial involved 213 healthy women who underwent elective caesarean delivery under spinal anaesthesia using 11 mg hyperbaric bupivacaine with 15 μg fentanyl and 100 μg morphine. The automated vasopressor group had better systolic pressure control, with 37/106 (34.9%) having any beat-to-beat systolic pressure reading control group (p 120% of baseline, with 8/106 (7.5%) in the automated vasopressor group vs 14/107 (13.1%) in the control group, or total dose of vasopressors. The automated vasopressor group had lower median absolute performance error of 8.5% vs control of 9.8% (p = 0.013), and reduced incidence of nausea (1/106 (0.9%) vs 11/107 (10.3%), p = 0.005). Neonatal umbilical cord pH, umbilical lactate and Apgar scores were similar. Hence, our system afforded better control of maternal blood pressure and reduced nausea with no increase in reactive hypertension when compared with manual boluses. © 2013 The Association of Anaesthetists of Great Britain and Ireland.

  19. Closing Statement

    International Nuclear Information System (INIS)

    Varjoranta, T.

    2015-01-01

    For me, this week has been a success. I have been impressed with the range and depth of discussion that has taken place, not only in the formal sessions, but also in the coffee breaks, over lunch and into the evening. When we placed an international call for papers earlier this year, we did not expect that we would receive 400 abstracts and end up arranging 237 oral presentations and 91 poster sessions. There have been over 600 participants originating from 54 Member States and 11 invited organizations. A wealth of information and analysis arising from this week's deliberations is now available on the Agency website. This provides you with the chance to catch up on any presentations that you may have missed the first time, as well as providing a resource for future research and application. If you recall, the purpose of the symposium was to foster dialogue and exchange of information involving Member States, the nuclear industry and members of the broader nuclear non-proliferation community, including civil society. I believe we have succeeded on that score. We are living in a rapidly changing world and the nuclear world is no exception. More nuclear material and facilities are coming under safeguards all the time. International nuclear cooperation between States is intensifying with an expansion of trade and services in nuclear and related equipment, items and materials. Also, technologies are changing. Many older nuclear plants are being modernized and becoming more technologically sophisticated. The geographical focus of these expanding programmes also continues to change. Yet, our budget remains static. This means that the only way we can maintain our effectiveness in the face of rising demand for our services, is to become more productive. That is the backdrop to this symposium. The overarching theme was to link strategy, implementation and people: the three core processes of any business. As I said on Monday, the strength of the link between these three

  20. Close binary stars

    International Nuclear Information System (INIS)

    Larsson-Leander, G.

    1979-01-01

    Studies of close binary stars are being persued more vigorously than ever, with about 3000 research papers and notes pertaining to the field being published during the triennium 1976-1978. Many major advances and spectacular discoveries were made, mostly due to increased observational efficiency and precision, especially in the X-ray, radio, and ultraviolet domains. Progress reports are presented in the following areas: observational techniques, methods of analyzing light curves, observational data, physical data, structure and models of close binaries, statistical investigations, and origin and evolution of close binaries. Reports from the Coordinates Programs Committee, the Committee for Extra-Terrestrial Observations and the Working Group on RS CVn binaries are included. (Auth./C.F.)

  1. A double-blind, randomized trial, including frequent patient–physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST study

    Science.gov (United States)

    Hassanein, Mohamed; Abdallah, Khalifa; Schweizer, Anja

    2014-01-01

    Background Several observational studies were conducted with vildagliptin in patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan, showing significantly lower incidences of hypoglycemia with vildagliptin versus sulfonylureas, including gliclazide. It was of interest to complement the existing real-life evidence with data from a randomized, double-blind, clinical trial. Clinical Trials Identifier NCT01758380. Methods This multiregional, double-blind study randomized 557 patients with T2DM (mean glycated hemoglobin [HbA1c], 6.9%), previously treated with metformin and any sulfonylurea to receive either vildagliptin (50 mg twice daily) or gliclazide plus metformin. The study included four office visits (three pre-Ramadan) and multiple telephone contacts, as well as Ramadan-focused advice. Hypoglycemic events were assessed during Ramadan; HbA1c and weight were analyzed before and after Ramadan. Results The proportion of patients reporting confirmed (Ramadan was 3.0% with vildagliptin and 7.0% with gliclazide (P=0.039; one-sided test), and this was 6.0% and 8.7%, respectively, for any hypoglycemic events (P=0.173). The adjusted mean change pre- to post-Ramadan in HbA1c was 0.05%±0.04% with vildagliptin and −0.03%±0.04% with gliclazide, from baselines of 6.84% and 6.79%, respectively (P=0.165). In both groups, the adjusted mean decrease in weight was −1.1±0.2 kg (P=0.987). Overall safety was similar between the treatments. Conclusion In line with the results from previous observational studies, vildagliptin was shown in this interventional study to be an effective, safe, and well-tolerated treatment in patients with T2DM fasting during Ramadan, with a consistently low incidence of hypoglycemia across studies, accompanied by good glycemic and weight control. In contrast, gliclazide showed a lower incidence of hypoglycemia in the present interventional than the previous observational studies. This is suggested to be linked to the specific

  2. Real Closed Rings and Real Closed * Rings

    OpenAIRE

    Capco, Jose

    2007-01-01

    Here we try to distinguish and compare different notions of real closedness mainly one developed by N. Schwartz in his Habilitationschrift and the other developed by A. Sankaranand K. Varadarajan which we shall call real closed *. We stick to the definition of real closed rings as defined and characterized N. Schwartz and we try to determine and characterize real closed rings that are real closed *. The main result is that real closed rings have unique real closure * and that real closure of ...

  3. Closing the achievement gap through modification of neurocognitive and neuroendocrine function: results from a cluster randomized controlled trial of an innovative approach to the education of children in kindergarten.

    Directory of Open Access Journals (Sweden)

    Clancy Blair

    Full Text Available Effective early education is essential for academic achievement and positive life outcomes, particularly for children in poverty. Advances in neuroscience suggest that a focus on self-regulation in education can enhance children's engagement in learning and establish beneficial academic trajectories in the early elementary grades. Here, we experimentally evaluate an innovative approach to the education of children in kindergarten that embeds support for self-regulation, particularly executive functions, into literacy, mathematics, and science learning activities. Results from a cluster randomized controlled trial involving 29 schools, 79 classrooms, and 759 children indicated positive effects on executive functions, reasoning ability, the control of attention, and levels of salivary cortisol and alpha amylase. Results also demonstrated improvements in reading, vocabulary, and mathematics at the end of kindergarten that increased into the first grade. A number of effects were specific to high-poverty schools, suggesting that a focus on executive functions and associated aspects of self-regulation in early elementary education holds promise for closing the achievement gap.

  4. Closing the achievement gap through modification of neurocognitive and neuroendocrine function: results from a cluster randomized controlled trial of an innovative approach to the education of children in kindergarten.

    Science.gov (United States)

    Blair, Clancy; Raver, C Cybele

    2014-01-01

    Effective early education is essential for academic achievement and positive life outcomes, particularly for children in poverty. Advances in neuroscience suggest that a focus on self-regulation in education can enhance children's engagement in learning and establish beneficial academic trajectories in the early elementary grades. Here, we experimentally evaluate an innovative approach to the education of children in kindergarten that embeds support for self-regulation, particularly executive functions, into literacy, mathematics, and science learning activities. Results from a cluster randomized controlled trial involving 29 schools, 79 classrooms, and 759 children indicated positive effects on executive functions, reasoning ability, the control of attention, and levels of salivary cortisol and alpha amylase. Results also demonstrated improvements in reading, vocabulary, and mathematics at the end of kindergarten that increased into the first grade. A number of effects were specific to high-poverty schools, suggesting that a focus on executive functions and associated aspects of self-regulation in early elementary education holds promise for closing the achievement gap.

  5. Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform.

    Science.gov (United States)

    Treweek, Shaun; Altman, Doug G; Bower, Peter; Campbell, Marion; Chalmers, Iain; Cotton, Seonaidh; Craig, Peter; Crosby, David; Davidson, Peter; Devane, Declan; Duley, Lelia; Dunn, Janet; Elbourne, Diana; Farrell, Barbara; Gamble, Carrol; Gillies, Katie; Hood, Kerry; Lang, Trudie; Littleford, Roberta; Loudon, Kirsty; McDonald, Alison; McPherson, Gladys; Nelson, Annmarie; Norrie, John; Ramsay, Craig; Sandercock, Peter; Shanahan, Daniel R; Summerskill, William; Sydes, Matt; Williamson, Paula; Clarke, Mike

    2015-06-05

    Randomised trials are at the heart of evidence-based healthcare, but the methods and infrastructure for conducting these sometimes complex studies are largely evidence free. Trial Forge ( www.trialforge.org ) is an initiative that aims to increase the evidence base for trial decision making and, in doing so, to improve trial efficiency.This paper summarises a one-day workshop held in Edinburgh on 10 July 2014 to discuss Trial Forge and how to advance this initiative. We first outline the problem of inefficiency in randomised trials and go on to describe Trial Forge. We present participants' views on the processes in the life of a randomised trial that should be covered by Trial Forge.General support existed at the workshop for the Trial Forge approach to increase the evidence base for making randomised trial decisions and for improving trial efficiency. Agreed upon key processes included choosing the right research question; logistical planning for delivery, training of staff, recruitment, and retention; data management and dissemination; and close down. The process of linking to existing initiatives where possible was considered crucial. Trial Forge will not be a guideline or a checklist but a 'go to' website for research on randomised trials methods, with a linked programme of applied methodology research, coupled to an effective evidence-dissemination process. Moreover, it will support an informal network of interested trialists who meet virtually (online) and occasionally in person to build capacity and knowledge in the design and conduct of efficient randomised trials.Some of the resources invested in randomised trials are wasted because of limited evidence upon which to base many aspects of design, conduct, analysis, and reporting of clinical trials. Trial Forge will help to address this lack of evidence.

  6. Clinical Trials

    Medline Plus

    Full Text Available ... taking the same treatment the same way. These patients are closely watched by Data and Safety Monitoring Boards. Even if you don't directly ... risk procedures (such as gene therapy) or vulnerable patients (such as ... trial for safety problems or differences in results among different groups. ...

  7. J-pouch vs. side-to-end anastomosis after hand-assisted laparoscopic low anterior resection for rectal cancer: A prospective randomized trial on short and long term outcomes including life quality and functional results.

    Science.gov (United States)

    Okkabaz, Nuri; Haksal, Mustafa; Atici, Ali Emre; Altuntas, Yunus Emre; Gundogan, Ersin; Gezen, Fazli Cem; Oncel, Mustafa

    2017-11-01

    To analyze the outcomes of j-pouch and side-to-end anastomosis in rectal cancer patients treated with laparoscopic hand-assisted low anterior resection. Prospective trial on cases randomized to have a colonic j-pouch or a side-to-end anastomosis after low anterior resection. Demographics, characteristics of disease and treatment, perioperative results, and functional outcomes and life quality were compared between the groups. Seventy four patients were randomized. Reservoir creation was withdrawn in 17 (23%) patients, mostly related to reach problem (n = 11, 64.7%). Anastomotic leakage rate was significantly higher in j-pouch group (8 [27.6%] vs. 0, p = 0.004). Stoma closure could not be achieved in 16 (28.1%) patients. Life quality and functional outcomes, measured 4, 8 and 12 months after the stoma reversal, were similar. Colonic j-pouch and side-to-end anastomosis are similar regarding perioperative measures including operation time, rates of postoperative complications, reoperation and 30-day mortality, and hospitalization period except anastomotic leak rate, which is higher in j-pouch group. Postoperative aspects are not different in patients receiving either technique including functional outcomes and life quality for the first year after stoma closure. In our opinion, both techniques may be preferred during the daily practice while performing laparoscopic surgery; but surgeons may be aware of a possibly higher anastomotic leak rate in case of a j-pouch. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  8. Study protocol: Cost effectiveness of two strategies to implement the NVOG guidelines on hypertension in pregnancy: An innovative strategy including a computerised decision support system compared to a common strategy of professional audit and feedback, a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Luitjes Susanne HE

    2010-09-01

    Full Text Available Abstract Background Hypertensive disease in pregnancy remains the leading cause of maternal mortality in the Netherlands. Seventeen percent of the clinical pregnancies are complicated by hypertension and 2% by preeclampsia. The Dutch Society of Obstetrics and Gynaecology (NVOG has developed evidence-based guidelines on the management of hypertension in pregnancy and chronic hypertension. Previous studies showed a low adherence rate to other NVOG guidelines and a large variation in usual care in the different hospitals. An explanation is that the NVOG has no general strategy of practical implementation and evaluation of its guidelines. The development of an effective and cost effective implementation strategy to improve adherence to the guidelines on hypertension in pregnancy is needed. Methods/Design The objective of this study is to assess the cost effectiveness of an innovative implementation strategy of the NVOG guidelines on hypertension including a computerised decision support system (BOS compared to a common strategy of professional audit and feedback. A cluster randomised controlled trial with an economic evaluation alongside will be performed. Both pregnant women who develop severe hypertension or pre-eclampsia and professionals involved in the care for these women will participate. The main outcome measures are a combined rate of major maternal complications and process indicators extracted from the guidelines. A total of 472 patients will be included in both groups. For analysis, descriptive as well as regression techniques will be used. A cost effectiveness and cost utility analysis will be performed according to the intention-to-treat principle and from a societal perspective. Cost effectiveness ratios will be calculated using bootstrapping techniques.

  9. Implant rehabilitation of the atrophic edentulous maxilla including immediate fixed provisional restoration without the use of bone grafting: a review of 1-year outcome data from a long-term prospective clinical trial.

    Science.gov (United States)

    Toljanic, Joseph A; Baer, Russell A; Ekstrand, Karl; Thor, Andreas

    2009-01-01

    The literature suggests that predictable integration can be achieved when dental implant placement is combined with immediate fixed provisional restoration in a variety of clinical situations. Fewer data are available, however, regarding outcomes for immediate provisional restoration of implants in the edentulous maxilla. This report presents 1-year data acquired from a long-term prospective clinical trial designed to assess outcomes following the immediate provisional fixed restoration of implants in the atrophic edentulous maxilla without the use of bone augmentation. Fifty-one subjects diagnosed with an atrophic edentulous maxilla received a total of 306 implants (six implants per subject) followed by fixed provisional restoration within 24 hours of implant placement. No subjects underwent grafting to enhance bone volume in preparation for implant treatment. Data acquired included bone quantity and quality, implant dimensions, implant locations, and implant placement stability. Subjects returned for 1-year follow-up examinations to assess implant integration and restoration function. Periapical radiographs were obtained and compared to baseline images to assess marginal bone height maintenance. At the 3-month follow-up examination, 294 of 306 implants placed in 51 subjects were found to be integrated. This represents a cumulative implant survival rate of 96%. At the 1-year follow-up examination, mean marginal bone loss of 0.5 mm was noted, with no further loss of implants. These results support the contention that predictable long-term outcomes may be obtained for the atrophic edentulous maxilla when treated with an implant rehabilitation protocol that includes immediate fixed provisional restoration without the use of bone grafting. This strategy offers a promising treatment alternative for the patient with an atrophic edentulous maxilla.

  10. Can municipality-based post-discharge follow-up visits including a general practitioner reduce early readmission among the fragile elderly (65+ years old)? A randomized controlled trial.

    Science.gov (United States)

    Thygesen, Lau Caspar; Fokdal, Sara; Gjørup, Thomas; Taylor, Rod S; Zwisler, Ann-Dorthe

    2015-06-01

    To evaluate how municipality-based post-discharge follow-up visits including a general practitioner and municipal nurse affect early readmission among high-risk older people discharged from a hospital department of internal medicine. Centrally randomized single-centre pragmatic controlled trial comparing intervention and usual care with investigator-blinded outcome assessment. The intervention was home visits with a general practitioner and municipal nurse within seven days of discharge focusing on medication, rehabilitation plan, functional level, and need for further health care initiatives. The visit was concluded by planning one or two further visits. Controls received standard health care services. People aged 65 + years discharged from Holbæk University Hospital, Denmark, in 2012 considered at high risk of readmission. The primary outcome was readmission within 30 days. Secondary outcomes at 30 and 180 days included readmission, primary health care, and municipal services. Outcomes were register-based and analysis used the intention-to-treat principle. A total of 270 and 261 patients were randomized to intervention and control groups, respectively. The groups were similar in baseline characteristics. In all 149 planned discharge follow-up visits were carried out (55%). Within 30 days, 24% of the intervention group and 23% of the control group were readmitted (p = 0.93). No significant differences were found for any other secondary outcomes except that the intervention group received more municipal nursing services. This municipality-based follow-up intervention was only feasible in half the planned visits. The intervention as delivered had no effect on readmission or subsequent use of primary or secondary health care services.

  11. [Closed suction drainage to prevent postoperative complications after parotidectomy: a systematic review].

    Science.gov (United States)

    Sun, Jun; Li, Chun-jie; Li, Bo; Gao, Qing-hong; Men, Yi; Li, Long-jiang

    2014-06-01

    To evaluate the efficacy and safety of closed suction drainage for prevention of postoperative complications after parotidectomy. Pubmed, Cochrane Controlled Trials Register, Embase, Open Sigle, CBM, VIP and Wanfang database were searched electronically from the date of their establishment to May 10,2013. Hand-searching covering 19 relevant Chinese journals were also performed, and the literature of randomized controlled trials comparing closed suction drainage and open drainage for prevention of postoperative complications after parotidectomy were included. Risk of bias assessment, which was suggested by Cochrane handbook for systematic reviewers of intervention review, and data extraction of included studies were delivered by two reviewers in duplicate; and meta analysis was performed with Revman 5.2 software. Ten randomized controlled trials were included. All studies had unclear risk of bias. When compared with open drainage, closed suction drainage showed a significant advantage on reducing postoperative complications (salivary fistula/effusion, edema) after parotidectomy; it also improved clinical comprehensive effect and patients' quality of life (P<0.05). To a certain extent, closed suction drainage has better efficacy and safety than controls in preventing postoperative complications after parotidectomy. However, as the quality of some included studies is limited, more randomized controlled trials are needed to reinforce the conclusion.

  12. A double-blind, randomized trial, including frequent patient-physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST study.

    Science.gov (United States)

    Hassanein, Mohamed; Abdallah, Khalifa; Schweizer, Anja

    2014-01-01

    Several observational studies were conducted with vildagliptin in patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan, showing significantly lower incidences of hypoglycemia with vildagliptin versus sulfonylureas, including gliclazide. It was of interest to complement the existing real-life evidence with data from a randomized, double-blind, clinical trial. NCT01758380. This multiregional, double-blind study randomized 557 patients with T2DM (mean glycated hemoglobin [HbA1c], 6.9%), previously treated with metformin and any sulfonylurea to receive either vildagliptin (50 mg twice daily) or gliclazide plus metformin. The study included four office visits (three pre-Ramadan) and multiple telephone contacts, as well as Ramadan-focused advice. Hypoglycemic events were assessed during Ramadan; HbA(1c) and weight were analyzed before and after Ramadan. The proportion of patients reporting confirmed (Ramadan was 3.0% with vildagliptin and 7.0% with gliclazide (P=0.039; one-sided test), and this was 6.0% and 8.7%, respectively, for any hypoglycemic events (P=0.173). The adjusted mean change pre- to post-Ramadan in HbA(1c) was 0.05%±0.04% with vildagliptin and -0.03%±0.04% with gliclazide, from baselines of 6.84% and 6.79%, respectively (P=0.165). In both groups, the adjusted mean decrease in weight was -1.1±0.2 kg (P=0.987). Overall safety was similar between the treatments. In line with the results from previous observational studies, vildagliptin was shown in this interventional study to be an effective, safe, and well-tolerated treatment in patients with T2DM fasting during Ramadan, with a consistently low incidence of hypoglycemia across studies, accompanied by good glycemic and weight control. In contrast, gliclazide showed a lower incidence of hypoglycemia in the present interventional than the previous observational studies. This is suggested to be linked to the specific circumstances of this study, including frequent patient-physician contacts

  13. A randomised double-blind placebo-controlled pilot trial of a combined extract of sage, rosemary and melissa, traditional herbal medicines, on the enhancement of memory in normal healthy subjects, including influence of age.

    Science.gov (United States)

    Perry, N S L; Menzies, R; Hodgson, F; Wedgewood, P; Howes, M-J R; Brooker, H J; Wesnes, K A; Perry, E K

    2018-01-15

    To evaluate for the first time the effects of a combination of sage, rosemary and melissa (Salvia officinalis L., Rosmarinus officinalis L. and Melissa officinalis L.; SRM), traditional European medicines, on verbal recall in normal healthy subjects. To devise a suitable study design for assessing the clinical efficacy of traditional herbal medicines for memory and brain function. Forty-four normal healthy subjects (mean age 61 ± 9.26y SD; m/f 6/38) participated in this study. A double-blind, randomised, placebo-controlled pilot study was performed with subjects randomised into an active and placebo group. The study consisted of a single 2-week term ethanol extract of SRM that was chemically-characterised using high resolution LC-UV-MS/MS analysis. Immediate and delayed word recall were used to assess memory after taking SRM or placebo (ethanol extract of Myrrhis odorata (L.) Scop.). In addition analysis was performed with subjects divided into younger and older subgroups (≤ 62 years mean age n = 26: SRM n = 10, Placebo n = 16; ≥ 63 years n = 19: SRM n = 13, Placebo n = 6). Overall there were no significant differences between treatment and placebo change from baseline for immediate or delayed word recall. However subgroup analysis showed significant improvements to delayed word recall in the under 63 year age group (p memory in healthy subjects under 63 years of age. Short- and long- term supplementation with SRM extract merits more robust investigation as an adjunctive treatment for patients with Alzheimer's disease and in the general ageing population. The study design proved a simple cost effective trial protocol to test the efficacy of herbal medicines on verbal episodic memory, with future studies including broader cognitive assessment. Copyright © 2017 Elsevier GmbH. All rights reserved.

  14. Clinical Trials

    Medline Plus

    Full Text Available ... how these studies should be done. Patient Rights Informed Consent Informed consent is the process of giving clinical trial participants ... part and during the course of the trial. Informed consent includes details about the treatments and tests you ...

  15. Media reporting of tenofovir trials in Cambodia and Cameroon

    Directory of Open Access Journals (Sweden)

    Wong Elaine

    2005-08-01

    Full Text Available Abstract Background Two planned trials of pre-exposure prophylaxis tenofovir in Cambodia and Cameroon to prevent HIV infection in high-risk populations were closed due to activist pressure on host country governments. The international news media contributed substantially as the primary source of knowledge transfer regarding the trials. We aimed to characterize the nature of reporting, specifically focusing on the issues identified by media reports regarding each trial. Methods With the aid of an information specialist, we searched 3 electronic media databases, 5 electronic medical databases and extensively searched the Internet. In addition we contacted stakeholder groups. We included media reports addressing the trial closures, the reasons for the trial closures, and who was interviewed. We extracted data using content analysis independently, in duplicate. Results We included 24 reports on the Cambodian trial closure and 13 reports on the Cameroon trial closure. One academic news account incorrectly reported that it was an HIV vaccine trial that closed early. The primary reasons cited for the Cambodian trial closure were: a lack of medical insurance for trial related injuries (71%; human rights considerations (71%; study protocol concerns (46%; general suspicions regarding trial location (37% and inadequate prevention counseling (29%. The primary reasons cited for the Cameroon trial closure were: inadequate access to care for seroconverters (69%; participants not sufficiently informed of risks (69%; inadequate number of staff (46%; participants being exploited (46% and an unethical study design (38%. Only 3/23 (13% reports acknowledged interviewing research personnel regarding the Cambodian trial, while 4/13 (30.8% reports interviewed researchers involved in the Cameroon trial. Conclusion Our review indicates that the issues addressed and validity of the media reports of these trials is highly variable. Given the potential impact of the media

  16. Closing the loop.

    Science.gov (United States)

    Dassau, E; Atlas, E; Phillip, M

    2010-02-01

    The dream of closing the loop is actually the dream of creating an artificial pancreas and freeing the patients from being involved with the care of their own diabetes. Insulin-dependent diabetes (type 1) is a chronic incurable disease which requires constant therapy without the possibility of any 'holidays' or insulin-free days. It means that patients have to inject insulin every day of their life, several times per day, and in order to do it safely they also have to measure their blood glucose levels several times per day. Patients need to plan their meals, their physical activities and their insulin regime - there is only very small room for spontaneous activities. This is why the desire for an artificial pancreas is so strong despite the fact that it will not cure the diabetic patients. Attempts to develop a closed-loop system started in the 1960s but never got to a clinical practical stage of development. In recent years the availability of continuous glucose sensors revived those efforts and stimulated the clinician and researchers to believe that closing the loop might be possible nowadays. Many papers have been published over the years describing several different ideas on how to close the loop. Most of the suggested systems have a sensing arm that measures the blood glucose repeatedly or continuously, an insulin delivery arm that injects insulin upon command and a computer that makes the decisions of when and how much insulin to deliver. The differences between the various published systems in the literature are mainly in their control algorithms. However, there are also differences related to the method and site of glucose measurement and insulin delivery. SC glucose measurements and insulin delivery are the most studied option but other combinations of insulin measurements and glucose delivery including intravascular and intraperitoneal (IP) are explored. We tried to select recent publications that we believe had influenced and inspired people interested

  17. Adding value to clinical trial registries: insights from Australian Cancer Trials Online, a website for consumers.

    Science.gov (United States)

    Dear, Rachel; Barratt, Alexandra; Askie, Lisa; McGeechan, Kevin; Arora, Sheena; Crossing, Sally; Currow, David; Tattersall, Martin

    2011-02-01

    Clinical trials registries are now operating in the USA, Europe, Australia, China, and India and more are planned. Trial registries could be an excellent source of information about clinical trials for patients and others affected by cancer as well as health care professionals, but may be difficult for patients to navigate and use. An opportunity arose in Australia to develop a consumer friendly cancer clinical trials website (Australian Cancer Trials Online (ACTO), www.australiancancertrials.gov.au) using an automated data feed from two large clinical trial registries. In this article, we describe aspects of this new website, and explore ways in which such a website may add value to clinical trial data which are already collected and held by trial registries. The development of ACTO was completed by a Web company working in close association with staff at the Australian New Zealand Clinical Trials Registry (ANZCTR), and with consumer representatives. Data for the website were sourced directly and only from clinical trial registries, thus avoiding the creation of an additional trials database. It receives an automated, daily data feed of newly registered cancer clinical trials from both the ANZCTR and Clinical Trials.gov. The development of ACTO exemplifies the advantage of a local clinical trial registry working with consumers to provide accessible information about cancer clinical trials to meet consumers' information needs. We found that the inclusion of a lay summary added substantial value for consumers, and recommend that consideration be given to adding a lay summary to the mandatory data items collected by all trial registries. Furthermore, improved navigation, decision support tools, and consistency in data collection between clinical trial registries will also enable consumer websites to provide additional value for users. Clinical trial registration is not compulsory in Australia. If the additional cancer items (including a lay summary) are not provided

  18. An open trial of individualized face-to-face cognitive behavior therapy for psychological distress in parents of children after end of treatment for childhood cancer including a cognitive behavioral conceptualization.

    Science.gov (United States)

    Ljungman, Lisa; Cernvall, Martin; Ghaderi, Ata; Ljungman, Gustaf; von Essen, Louise; Ljótsson, Brjánn

    2018-01-01

    A subgroup of parents of children who have been treated for childhood cancer report high levels of psychological distress. To date there is no empirically supported psychological treatment targeting cancer-related psychological distress in this population. The aim of the current study was to test the feasibility and preliminarily evaluate the effect of individualized face-to-face cognitive behavior therapy (CBT) for parents of children after the end of treatment for childhood cancer. A secondary aim was to present a cognitive behavioral conceptualization of cancer-related distress for these parents. An open trial was conducted where 15 parents of children who had completed successful treatment for cancer three months to five years earlier and who reported psychological distress related to a child's previous cancer disease were provided CBT at a maximum of 15 sessions. Participants were assessed at baseline, post-intervention, and three-month follow-up using self-reported psychological distress (including posttraumatic stress symptoms (PTSS), depression, and anxiety) and the diagnostic Mini-International Neuropsychiatric Interview. Feasibility outcomes relating to recruitment, data collection, and delivery of the treatment were also examined. Individual case formulations for each participant guided the intervention and these were aggregated and presented in a conceptualization detailing core symptoms and their suggested maintenance mechanisms. A total of 93% of the participants completed the treatment and all of them completed the follow-up assessment. From baseline to post-assessment, parents reported significant improvements in PTSS, depression, and anxiety with medium to large effect sizes (Cohen's d = 0.65-0.92). Results were maintained or improved at a three-month follow-up. At baseline, seven (47%) participants fulfilled the diagnostic criteria for major depressive disorder and four (29%) fulfilled the criteria for posttraumatic stress disorder, compared to

  19. Curative or pre-emptive adenovirus-specific T cell transfer from matched unrelated or third party haploidentical donors after HSCT, including UCB transplantations: a successful phase I/II multicenter clinical trial

    Directory of Open Access Journals (Sweden)

    Chongsheng Qian

    2017-05-01

    Full Text Available Abstract Background Allogeneic hematopoietic stem cell transplantation (HSCT, the most widely used potentially curable cellular immunotherapeutic approach in the treatment of hematological malignancies, is limited by life-threatening complications: graft versus host disease (GVHD and infections especially viral infections refractory to antiviral drugs. Adoptive transfer of virus-specific T cells is becoming an alternative treatment for infections following HSCT. We report here the results of a phase I/II multicenter study which includes a series of adenovirus-specific T cell (ADV-VST infusion either from the HSCT donor or from a third party haploidentical donor for patients transplanted with umbilical cord blood (UCB. Methods Fourteen patients were eligible and 11 patients received infusions of ADV-VST generated by interferon (IFN-γ-based immunomagnetic isolation from a leukapheresis from their original donor (42.9% or a third party haploidentical donor (57.1%. One patient resolved ADV infection before infusion, and ADV-VST could not reach release or infusion criteria for two patients. Two patients received cellular immunotherapy alone without antiviral drugs as a pre-emptive treatment. Results One patient with adenovirus infection and ten with adenovirus disease were infused with ADV-VST (mean 5.83 ± 8.23 × 103 CD3+IFN-γ+ cells/kg up to 9 months after transplantation. The 11 patients showed in vivo expansion of specific T cells up to 60 days post-infusion, associated with adenovirus load clearance in ten of the patients (91%. Neither de novo GVHD nor side effects were observed during the first month post-infusion, but GVHD reactivations occurred in three patients, irrespective of the type of leukapheresis donor. For two of these patients, GVHD reactivation was controlled by immunosuppressive treatment. Four patients died during follow-up, one due to refractory ADV disease. Conclusions Adoptive transfer of rapidly isolated ADV

  20. Clinical Trials

    Medline Plus

    Full Text Available ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ... Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute of Health ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... or groups of people; look at the best age and frequency for doing screening tests, such as ... trial. They include factors such as a patient's age and gender, the type and stage of disease, ...

  2. Clinical Trials

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    Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ...

  3. Clinical Trials

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

  4. Clinical Trials

    Medline Plus

    Full Text Available ... organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and ... how you feel. Some people will need to travel or stay in hospitals to take part in ...

  5. Clinical Trials

    Medline Plus

    Full Text Available ... study explored whether the benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials that test principles or strategies include studies that explore whether ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and ...

  7. Efficacy and safety of recombinant human bone morphogenetic protein-2/calcium phosphate matrix for closed tibial diaphyseal fracture: a double-blind, randomized, controlled phase-II/III trial.

    Science.gov (United States)

    Lyon, Thomas; Scheele, Wim; Bhandari, Mohit; Koval, Kenneth J; Sanchez, Eduardo Gomez; Christensen, Jared; Valentin, Alexandre; Huard, Francois

    2013-12-04

    Recombinant human bone morphogenetic protein-2 (rhBMP-2) applied on an absorbable collagen sponge improves open tibial fracture-healing as an adjunct to unreamed intramedullary nail fixation. We evaluated rhBMP-2 and a new, injectable calcium phosphate matrix (CPM) formulation in acute closed tibial diaphyseal fractures treated with reamed intramedullary nail fixation. Patients were randomized (1:2:2:1) to receive standard of care, which consisted of definitive fracture fixation within seventy-two hours of injury with a locked intramedullary nail after reaming; standard of care and injection with 1.0 mg/mL of rhBMP-2/CPM; standard of care and injection with 2.0 mg/mL of rhBMP-2/CPM; or standard of care and injection with buffer/CPM, to evaluate the activity of the CPM delivery matrix and provide for sponsor and investigator blinding. The co-primary end points of the study were the effects of rhBMP-2/CPM on the time to fracture union (based on blinded assessment of radiographs) and the time to return to normal function (based on blinded assessment of the time to full weight-bearing without pain at the fracture site) compared with standard of care alone. Three hundred and sixty-nine patients were randomized and included in the intent-to-treat population. This study was terminated after an interim analysis (180 patients with six months of follow-up) revealed no shortening in the time to fracture union in the active treatment arms compared with the standard of care control (the SOC group). In the final primary analysis, the median time to radiographic fracture union was not significantly different for the SOC (13.1 weeks), 1.0-mg/mL rhBMP-2/CPM (13.0 weeks), 2.0-mg/mL rhBMP-2/CPM (15.9 weeks), or buffer/CPM (15.4 weeks) treatment groups. The median time to pain-free full weight-bearing was also not significantly different among the SOC (13.4 weeks), 1.0-mg/mL rhBMP-2/CPM (13.4 weeks), 2.0-mg/mL rhBMP-2/CPM (14.3 weeks), and buffer/CPM (16.4 weeks) treatment groups. In

  8. Jealousy and Relationship Closeness

    Directory of Open Access Journals (Sweden)

    Mark Attridge

    2013-02-01

    Full Text Available This study confirmed a hypothesis from the Emotion-in-Relationships conceptual model, which predicts that greater interdependence between relationship partners—or closeness—creates the potential for jealousy. The study also sought to better define the positive side of romantic jealousy in addition to its more negative attributes. College students in premarital relationships (N = 229 completed a questionnaire, including 27 different measures and the Multidimensional Jealousy Scale. Select data were obtained from 122 cases at 3-month follow-up. Each jealousy scale was tested for associations with demographic (age, sex, and race, person (life satisfaction, loneliness, romantic attachment styles, love styles, and romantic beliefs, and relationship (affective, closeness, and social exchange theory constructs. Results clearly distinguished emotional/reactive jealousy as mostly “good” and cognitive/suspicious jealousy as “bad.” Behavioral jealousy was associated with few measures. Implications are discussed for the interdependence model of relationships and the transactional model of jealousy.

  9. Science policy up close

    CERN Document Server

    Marburger, John H

    2015-01-01

    In a career that included tenures as president of Stony Brook University, director of Brookhaven National Laboratory, and science advisor to President George W. Bush, John Marburger (1941 2011) found himself on the front line of battles that pulled science ever deeper into the political arena. From nuclear power to global warming and stem cell research, science controversies, he discovered, are never just about science. Science Policy Up Close" presents Marburger s reflections on the challenges science administrators face in the twenty-first century. In each phase of public service Marburger came into contact with a new dimension of science policy. The Shoreham Commission exposed him to the problem of handling a volatile public controversy over nuclear power. The Superconducting Super Collider episode gave him insights into the collision between government requirements and scientists expectations and feelings of entitlement. The Directorship of Brookhaven taught him how to talk to the public about the risks ...

  10. Close Air Support versus Close Combat Attack

    Science.gov (United States)

    2012-12-06

    consequence when discussing the two different processes of close air support and close combat attack. This section focuses on service culture. Understanding...According to a RAND study written by Carl Builder, the Air Force “could be said to worship at the altar of technology.”67 These are not what Hofstede...characteristics that are highly prized in a culture and thus serve as models for behavior,” people like Billy Mitchell, Hap Arnold, Tooey Spaatz to name a

  11. Closed cycle gas dynamic laser

    International Nuclear Information System (INIS)

    Pinsley, E.A.

    1975-01-01

    The device includes a closed cycle gasdynamic laser wherein the lasing fluid is recirculated in a closed loop. The closed loop includes a nozzle array, a lasing cavity and a diffuser. The exit of the diffuser is connected to the inlet to the nozzle array with a fuel heat exchanger located in the lasing flow and a pumping means located between the heat exchanger and the nozzle array. To provide for cooling of the pumping means and to improve diffuser performance, gas bled from the diffuser is cooled by two heat exchangers and pumped into cooling passages in the pumping means. The heat exchangers for cooling the flow to the pumping means are located in series and carry fuel from a supply to an injector in said combustor and the heat exchanger in the lasing flow cools the fluid and carries the fuel from a supply to an injector in said combustor. (U.S.)

  12. Close-Ups

    DEFF Research Database (Denmark)

    Fausing, Bent

    2013-01-01

    Investigations in the close-up and its meaning regarding nearness, abstraction and transparency. Face, facelike and animism are also major key-words in thsi article... . I have always been fascinated with the close-up, not as an end, but a filter of opportunities to open up for and nearness...... of transcendence, associations and memories. The close-up is not the end, it rather in my view to be regarded as a beginning of different perceptions...

  13. Including whey protein and whey permeate in ready-to-use supplementary food improves recovery rates in children with moderate acute malnutrition: a randomized, double-blind clinical trial.

    Science.gov (United States)

    Stobaugh, Heather C; Ryan, Kelsey N; Kennedy, Julie A; Grise, Jennifer B; Crocker, Audrey H; Thakwalakwa, Chrissie; Litkowski, Patricia E; Maleta, Kenneth M; Manary, Mark J; Trehan, Indi

    2016-03-01

    The utility of dairy ingredients in the supplementary foods used in the treatment of childhood moderate acute malnutrition (MAM) remains unsettled. We evaluated the effectiveness of a peanut-based ready-to-use supplementary food (RUSF) with soy protein compared with a novel RUSF containing dairy ingredients in the form of whey permeate and whey protein concentrate in the treatment of children with MAM. We conducted a randomized, double-blind clinical effectiveness trial involving rural Malawian and Mozambican children 6-59 mo of age with MAM treated with either soy RUSF or a novel whey RUSF treatment of ~75 kcal · kg(-1) · d(-1) for up to 12 wk. The proportion of children that recovered from MAM was significantly higher in the group that received whey RUSF (960 of 1144; 83.9%) than in the group that received soy RUSF (874 of 1086; 80.5%; P whey RUSF also demonstrated better growth markers, with a higher mean midupper arm circumference (MUAC) at the time of discharge (P protein in the treatment of MAM, because the use of a novel whey RUSF resulted in higher recovery rates and improved growth than did soy RUSF, although the whey RUSF supplement provided less total protein and energy than the soy RUSF. This study was registered at clinicaltrials.gov as NCT01790048. © 2016 American Society for Nutrition.

  14. Ecological Challenges for Closed Systems

    Science.gov (United States)

    Nelson, Mark; Dempster, William; Allen, John P.

    2012-07-01

    Closed ecological systems are desirable for a number of purposes. In space life support systems, material closure allows precious life-supporting resources to be kept inside and recycled. Closure in small biospheric systems facilitates detailed measurement of global ecological processes and biogeochemical cycles. Closed testbeds facilitate research topics which require isolation from the outside (e.g. genetically modified organisms; radioisotopes) so their ecological interactions and fluxes can be studied separate from interactions with the outside environment. But to achieve and maintain closure entails solving complex ecological challenges. These challenges include being able to handle faster cycling rates and accentuated daily and seasonal fluxes of critical life elements such as carbon dioxide, oxygen, water, macro- and mico-nutrients. The problems of achieving sustainability in closed systems for life support include how to handle atmospheric dynamics including trace gases, producing a complete human diet and recycling nutrients and maintaining soil fertility, the sustaining of healthy air and water and preventing the loss of crucial elements from active circulation. In biospheric facilities the challenge is also to produce analogues to natural biomes and ecosystems, studying processes of self-organization and adaptation in systems that allow specification or determination of state variables and cycles which may be followed through all interactions from atmosphere to soils. Other challenges include the dynamics and genetics of small populations, the psychological challenges for small isolated human groups and measures and options which may be necessary to ensure long-term operation of closed ecological systems.

  15. Graph topologies on closed multifunctions

    Directory of Open Access Journals (Sweden)

    Giuseppe Di Maio

    2003-10-01

    Full Text Available In this paper we study function space topologies on closed multifunctions, i.e. closed relations on X x Y using various hypertopologies. The hypertopologies are in essence, graph topologies i.e topologies on functions considered as graphs which are subsets of X x Y . We also study several topologies, including one that is derived from the Attouch-Wets filter on the range. We state embedding theorems which enable us to generalize and prove some recent results in the literature with the use of known results in the hyperspace of the range space and in the function space topologies of ordinary functions.

  16. 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.

  17. Pump apparatus including deconsolidator

    Energy Technology Data Exchange (ETDEWEB)

    Sonwane, Chandrashekhar; Saunders, Timothy; Fitzsimmons, Mark Andrew

    2014-10-07

    A pump apparatus includes a particulate pump that defines a passage that extends from an inlet to an outlet. A duct is in flow communication with the outlet. The duct includes a deconsolidator configured to fragment particle agglomerates received from the passage.

  18. Clinical Trials

    Medline Plus

    Full Text Available ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore ...

  19. Inflation in a closed universe

    Science.gov (United States)

    Ratra, Bharat

    2017-11-01

    To derive a power spectrum for energy density inhomogeneities in a closed universe, we study a spatially-closed inflation-modified hot big bang model whose evolutionary history is divided into three epochs: an early slowly-rolling scalar field inflation epoch and the usual radiation and nonrelativistic matter epochs. (For our purposes it is not necessary to consider a final dark energy dominated epoch.) We derive general solutions of the relativistic linear perturbation equations in each epoch. The constants of integration in the inflation epoch solutions are determined from de Sitter invariant quantum-mechanical initial conditions in the Lorentzian section of the inflating closed de Sitter space derived from Hawking's prescription that the quantum state of the universe only include field configurations that are regular on the Euclidean (de Sitter) sphere section. The constants of integration in the radiation and matter epoch solutions are determined from joining conditions derived by requiring that the linear perturbation equations remain nonsingular at the transitions between epochs. The matter epoch power spectrum of gauge-invariant energy density inhomogeneities is not a power law, and depends on spatial wave number in the way expected for a generalization to the closed model of the standard flat-space scale-invariant power spectrum. The power spectrum we derive appears to differ from a number of other closed inflation model power spectra derived assuming different (presumably non de Sitter invariant) initial conditions.

  20. Optical modulator including grapene

    Science.gov (United States)

    Liu, Ming; Yin, Xiaobo; Zhang, Xiang

    2016-06-07

    The present invention provides for a one or more layer graphene optical modulator. In a first exemplary embodiment the optical modulator includes an optical waveguide, a nanoscale oxide spacer adjacent to a working region of the waveguide, and a monolayer graphene sheet adjacent to the spacer. In a second exemplary embodiment, the optical modulator includes at least one pair of active media, where the pair includes an oxide spacer, a first monolayer graphene sheet adjacent to a first side of the spacer, and a second monolayer graphene sheet adjacent to a second side of the spacer, and at least one optical waveguide adjacent to the pair.

  1. Pseudo Algebraically Closed Extensions

    Science.gov (United States)

    Bary-Soroker, Lior

    2009-07-01

    This PhD deals with the notion of pseudo algebraically closed (PAC) extensions of fields. It develops a group-theoretic machinery, based on a generalization of embedding problems, to study these extensions. Perhaps the main result is that although there are many PAC extensions, the Galois closure of a proper PAC extension is separably closed. The dissertation also contains the following subjects. The group theoretical counterpart of pseudo algebraically closed extensions, the so-called projective pairs. Applications to seemingly unrelated subjects, e.g., an analog of Dirichlet's theorem about primes in arithmetic progression for polynomial rings in one variable over infinite fields.

  2. Closed Claim Query File

    Data.gov (United States)

    Social Security Administration — This file is used to hold information about disability claims that have been closed and have been selected for sampling.Sampling is the process whereby OQR reviews...

  3. Factors influencing efficiency of sliding mechanics to close extraction space: a systematic review.

    Science.gov (United States)

    Barlow, M; Kula, K

    2008-05-01

    To review recent literature to determine strength of clinical evidence concerning the influence of various factors on the efficiency (rate of tooth movement) of closing extraction spaces using sliding mechanics. A comprehensive systematic review on prospective clinical trials. An electronic search (1966-2006) of several databases limiting the searches to English and using several keywords was performed. Also a hand search of five key journals specifically searching for prospective clinical trials relevant to orthodontic space closure using sliding mechanics was completed. Outcome Measure - Rate of tooth movement. Ten prospective clinical trials comparing rates of closure under different variables and focusing only on sliding mechanics were selected for review. Of these ten trials on rate of closure, two compared arch wire variables, seven compared material variables used to apply force, and one examined bracket variables. Other articles which were not prospective clinical trials on sliding mechanics, but containing relevant information were examined and included as background information. CONCLUSION - The results of clinical research support laboratory results that nickel-titanium coil springs produce a more consistent force and a faster rate of closure when compared with active ligatures as a method of force delivery to close extraction space along a continuous arch wire; however, elastomeric chain produces similar rates of closure when compared with nickel-titanium springs. Clinical and laboratory research suggest little advantage of 200 g nickel-titanium springs over 150 g springs. More clinical research is needed in this area.

  4. The Trial

    Science.gov (United States)

    Bryant, Jen

    2004-01-01

    Growing up in Flemington, New Jersey, put Jen Bryant in the heart of the lore behind the Lindbergh baby kidnapping. Family stories of the events of the day and extensive research led to "The Trial," a novel in verse. The first several parts of this novel are included here.

  5. Clinical Trials

    Medline Plus

    Full Text Available ... examples of clinical trials that test principles or strategies include studies that explore whether surgery or other medical treatments ... board consists of a group of research and study topic experts. The NIH also ... alternative strategies for diagnosis or treatment. In addition, the NIH ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... include factors such as a patient's age and gender, the type and stage of disease, ... helps ensure that any differences observed during a trial are due to the ...

  8. Clinical Trials

    Science.gov (United States)

    ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... include factors such as a patient's age and gender, the type and stage of disease, ... helps ensure that any differences observed during a trial are due to the ...

  9. ISABELLE closed orbit correction system

    International Nuclear Information System (INIS)

    Parzen, G.

    1977-01-01

    The proposed closed orbit correction system for the ISABELLE storage accelerators is described. Results given include the initial orbit displacement error expected, the degree of correction that is expected by moving quadrupoles and by exciting dipole correction coils, the limitations on orbit correction due to the number and location of the probes (pick-up electrodes) and the accuracy requirements on the power supplies that stem primarily from the need to keep the two narrow beams in proper collision with each other

  10. Safety of a novel parenteral formulation of diclofenac after major orthopedic or abdominal/pelvic surgery in a population including anticoagulated, elderly or renally insufficient patients: an open-label, multiday, repeated dose clinical trial.

    Science.gov (United States)

    Chelly, Jacques E; Singla, Sonia K; Melson, Timothy I; Lacouture, Peter G; Paadre, Susan; Carr, Daniel B

    2013-05-01

    Decisions to use or avoid nonsteroidal anti-inflammatory drugs (NSAIDs) for postsurgical pain are often influenced by concerns about bleeding and renal adverse effects. The objective of this study was to evaluate the safety of a novel parenteral NSAID, hydroxypropyl-β-cyclodextrin (HPβCD) diclofenac, in a large postsurgical patient population, with particular focus on bleeding and renal effects. This was a large open-label study in adult patients with acute moderate-to-severe pain following major surgery. Patients received ≥2 days of continuous treatment with HPβCD diclofenac, administered as a small-volume bolus injection every 6 hours. Few exclusion criteria were applied in order to reflect surgical patient populations commonly managed in clinical practice. Adverse events (AEs) were recorded throughout the study. The incidences of bleeding- and renal-related AEs were examined in patient subpopulations with known risk factors for NSAID-induced complications: advanced age, pre-existing renal insufficiency, concomitant anticoagulant use, prolonged exposure, elevated dosage, and major surgeries. Of the total 971 patients studied, 38% were ≥65 years old (12% >75 years), 62% received concomitant anticoagulants, and 6% had pre-existing renal insufficiency. HPβCD diclofenac was well tolerated by the patient population. AE rates are presented by risk factor to enable clinicians to better describe renal- or bleeding-related AEs. In addition to its previously demonstrated efficacy, this study provides evidence of HPβCD diclofenac's safety in a large postsurgical population including anticoagulated, elderly or renally insufficient patients. Because study exclusion criteria were minimal, these findings may be broadly generalizable to populations commonly treated in clinical practice. Wiley Periodicals, Inc.

  11. Closing global material loops

    DEFF Research Database (Denmark)

    Prosman, Ernst-Jan; Wæhrens, Brian Vejrum; Liotta, Giacomo

    2017-01-01

    Replacing virgin materials with waste materials, a practice known as Industrial Symbiosis (IS), has been identified as a key strategy for closing material loops. This article adopts a critical view on geographic proximity and external coordinators – two key enablers of IS. By ‘uncovering’ a case ...... for geographic proximity and external coordinators. In doing so, our insights into firm-level challenges of long-distance IS exchanges contribute to closing global material loops by increasing the number of potential circular pathways....

  12. Closed Loop Subspace Identification

    Directory of Open Access Journals (Sweden)

    Geir W. Nilsen

    2005-07-01

    Full Text Available A new three step closed loop subspace identifications algorithm based on an already existing algorithm and the Kalman filter properties is presented. The Kalman filter contains noise free states which implies that the states and innovation are uneorre lated. The idea is that a Kalman filter found by a good subspace identification algorithm will give an output which is sufficiently uncorrelated with the noise on the output of the actual process. Using feedback from the output of the estimated Kalman filter in the closed loop system a subspace identification algorithm can be used to estimate an unbiased model.

  13. Closed Circuit Videoinstallationen

    DEFF Research Database (Denmark)

    Kacunko, Slavko

    be seen with only insignificant qualification as a specific characteristic of the medium. The closed-circuit video installations based on it represent the attest field of experiment for the assumptions on art and the theory and history of the medium that it might lead one make. In recent years...

  14. Review: The Closing Circle

    Science.gov (United States)

    Environment, 1972

    1972-01-01

    Two views of prominent biologists are presented side-by-side. Focal point is Barry Commoner's book, The Closing Circle, with a subsequent review by Paul Ehrlich. Growth of population, increases in affluence, and increased pollution from products of technology are considered. (BL)

  15. 'Closed Circuit' Anaesthesia

    African Journals Online (AJOL)

    The advantages of using rebreathing circuits in anaes- thesia are discussed and the principles for their correct employment are outlined. Practical methods are described. By using closed circuit equipment in the manner described, the initial cost of the apparatus could be recouped within one year, because of the saving in ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a ... purpose is to ensure that clinical trials are ethical and that the participants' rights are protected. The ...

  17. Clinical Trials

    Medline Plus

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

  18. Clinical Trials

    Medline Plus

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

  19. Clinical Trials

    Medline Plus

    Full Text Available ... study results. Clinical Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  20. Musculoskeletal ultrasound including definitions for ultrasonographic pathology

    DEFF Research Database (Denmark)

    Wakefield, RJ; Balint, PV; Szkudlarek, Marcin

    2005-01-01

    Ultrasound (US) has great potential as an outcome in rheumatoid arthritis trials for detecting bone erosions, synovitis, tendon disease, and enthesopathy. It has a number of distinct advantages over magnetic resonance imaging, including good patient tolerability and ability to scan multiple joint...

  1. Conservative management following closed reduction of traumatic anterior dislocation of the shoulder.

    Science.gov (United States)

    Hanchard, Nigel C A; Goodchild, Lorna M; Kottam, Lucksy

    2014-04-30

    Acute anterior dislocation, which is the most common type of shoulder dislocation, usually results from an injury. Subsequently, the shoulder is less stable and is more susceptible to re-dislocation, especially in active young adults. This is an update of a Cochrane review first published in 2006. To assess the effects (benefits and harms) of conservative interventions after closed reduction of traumatic anterior dislocation of the shoulder. These might include immobilisation, rehabilitative interventions or both. We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (September 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 8), MEDLINE (1946 to September 2013), EMBASE (1980 to Week 38, 2013), CINAHL (1982 to September 2013), PEDro (1929 to November 2012), OTseeker (inception to November 2012) and trial registries. We also searched conference proceedings and reference lists of included studies. Randomised or quasi-randomised controlled trials comparing various conservative interventions versus control (no or sham treatment) or other conservative interventions applied after closed reduction of traumatic anterior dislocation of the shoulder. All review authors independently selected trials, assessed risk of bias and extracted data. Study authors were contacted for additional information. Results of comparable groups of trials were pooled. We included three randomised trials and one quasi-randomised trial, which involved 470 participants (371 male) with primary traumatic anterior dislocation of the shoulder reduced by various closed methods. Three studies evaluated mixed populations; in the fourth study, all participants were male and 80% were soldiers. All trials were at some risk of bias but to a differing extent. One was at high risk in all domains of the risk of bias tool, and one was at unclear or high risk in all domains; the other two trials were deemed to have predominantly low risk across all

  2. Closing the gasoline system

    International Nuclear Information System (INIS)

    Hutcheson, R.C.

    1992-01-01

    In this paper, a representative of the Oil Companies' European Organization for Environmental and Health Protection (CONCAWE), argues the advantages of closing the gasoline system. Because this decouples the product from the environment, health risks and environmental damage are reduced. It is also more effective than changing the composition of gasoline because it offers better cost effectiveness, energy efficiency and the minimization of carbon dioxide release into the environment. However it will take time and political will to change until all European vehicles are fitted with three way catalysts and carbon canisters: control systems to monitor such systems will also need to be set up. However CONCAWE still recommends its adoption. (UK)

  3. Closed Strings From Nothing

    International Nuclear Information System (INIS)

    Lawrence, Albion

    2001-01-01

    We study the physics of open strings in bosonic and type II string theories in the presence of unstable D-branes. When the potential energy of the open string tachyon is at its minimum, Sen has argued that only closed strings remain in the perturbative spectrum. We explore the scenario of Yi and of Bergman, Hori and Yi, who argue that the open string degrees of freedom are strongly coupled and disappear through confinement. We discuss arguments using open string field theory and worldsheet boundary RG flows, which seem to indicate otherwise. We then describe a solitonic excitation of the open string tachyon and gauge field with the charge and tension of a fundamental closed string. This requires a double scaling limit where the tachyon is taken to its minimal value and the electric field is taken to its maximum value. The resulting flux tube has an unconstrained spatial profile; and for large fundamental string charge, it appears to have light, weakly coupled open strings living in the core. We argue that the flux tube acquires a size or order α' through sigma model and string coupling effects; and we argue that confinement effects make the light degrees of freedom heavy and strongly interacting

  4. Closed Strings From Nothing

    Energy Technology Data Exchange (ETDEWEB)

    Lawrence, Albion

    2001-07-25

    We study the physics of open strings in bosonic and type II string theories in the presence of unstable D-branes. When the potential energy of the open string tachyon is at its minimum, Sen has argued that only closed strings remain in the perturbative spectrum. We explore the scenario of Yi and of Bergman, Hori and Yi, who argue that the open string degrees of freedom are strongly coupled and disappear through confinement. We discuss arguments using open string field theory and worldsheet boundary RG flows, which seem to indicate otherwise. We then describe a solitonic excitation of the open string tachyon and gauge field with the charge and tension of a fundamental closed string. This requires a double scaling limit where the tachyon is taken to its minimal value and the electric field is taken to its maximum value. The resulting flux tube has an unconstrained spatial profile; and for large fundamental string charge, it appears to have light, weakly coupled open strings living in the core. We argue that the flux tube acquires a size or order {alpha}' through sigma model and string coupling effects; and we argue that confinement effects make the light degrees of freedom heavy and strongly interacting.

  5. Clinical Trials

    Medline Plus

    Full Text Available ... clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All types of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for advancing medical knowledge and patient ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore whether ...

  7. Feasibility of Outpatient Fully Integrated Closed-Loop Control

    Science.gov (United States)

    Kovatchev, Boris P.; Renard, Eric; Cobelli, Claudio; Zisser, Howard C.; Keith-Hynes, Patrick; Anderson, Stacey M.; Brown, Sue A.; Chernavvsky, Daniel R.; Breton, Marc D.; Farret, Anne; Pelletier, Marie-Josée; Place, Jérôme; Bruttomesso, Daniela; Del Favero, Simone; Visentin, Roberto; Filippi, Alessio; Scotton, Rachele; Avogaro, Angelo; Doyle, Francis J.

    2013-01-01

    OBJECTIVE To evaluate the feasibility of a wearable artificial pancreas system, the Diabetes Assistant (DiAs), which uses a smart phone as a closed-loop control platform. RESEARCH DESIGN AND METHODS Twenty patients with type 1 diabetes were enrolled at the Universities of Padova, Montpellier, and Virginia and at Sansum Diabetes Research Institute. Each trial continued for 42 h. The United States studies were conducted entirely in outpatient setting (e.g., hotel or guest house); studies in Italy and France were hybrid hospital–hotel admissions. A continuous glucose monitoring/pump system (Dexcom Seven Plus/Omnipod) was placed on the subject and was connected to DiAs. The patient operated the system via the DiAs user interface in open-loop mode (first 14 h of study), switching to closed-loop for the remaining 28 h. Study personnel monitored remotely via 3G or WiFi connection to DiAs and were available on site for assistance. RESULTS The total duration of proper system communication functioning was 807.5 h (274 h in open-loop and 533.5 h in closed-loop), which represented 97.7% of the total possible time from admission to discharge. This exceeded the predetermined primary end point of 80% system functionality. CONCLUSIONS This study demonstrated that a contemporary smart phone is capable of running outpatient closed-loop control and introduced a prototype system (DiAs) for further investigation. Following this proof of concept, future steps should include equipping insulin pumps and sensors with wireless capabilities, as well as studies focusing on control efficacy and patient-oriented clinical outcomes. PMID:23801798

  8. Clinical Trials

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    Full Text Available ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ... stop a trial, or part of a trial, early if the strategy or treatment is having harmful ...

  9. Clinical Trials

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    Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

  10. Clinical Trials

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    Full Text Available ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

  11. Clinical Trials

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    Full Text Available ... Blood Institute (NHLBI) sponsored a trial of two different combinations of asthma treatments. The trial found that ... ways, taking part in a clinical trial is different from having regular care from your own doctor. ...

  12. Clinical Trials

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    Full Text Available ... groups of people. Some clinical trials show a positive result. For example, the National Heart, Lung, and ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

  13. Clinical Trials

    Medline Plus

    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ...

  14. Clinical Trials

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    Full Text Available ... possible benefits. Clinical Trial Phases Clinical trials of new medicines or medical devices are done in phases. These ... provides oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews applications for ...

  15. Clinical Trials

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    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...

  16. Clinical Trials

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    Full Text Available ... to the strategies and treatments that work best. How Clinical Trials Work If you take part in ... a protocol (PRO-to-kol). This plan explains how the trial will work. The trial is led ...

  17. Clinical Trials

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    Full Text Available ... more information about eligibility criteria, go to "How Do Clinical Trials Work?" Some trials enroll people who ... for adults. For more information, go to "How Do Clinical Trials Protect Participants?" For more information about ...

  18. Closed loop reflux system

    International Nuclear Information System (INIS)

    De Witt, R.; Jepson, B.E.; Schwind, R.A.

    1975-01-01

    Sulfur isotopes are continuously separated and enriched using a closed loop reflux system wherein sulfur dioxide (SO 2 ) is reacted with sodium hydroxide (NaOH) or the like to form sodium hydrogen sulfite (NaHSO 3 ). Heavier sulfur isotopes are preferentially attracted to the NaHSO 3 , and subsequently reacted with sulfuric acid (H 2 SO 4 ) forming sodium hydrogen sulfate (NaHSO 4 ) and SO 2 gas, which contains increased concentrations of the heavier sulfur isotopes. This heavy isotope enriched SO 2 gas is subsequently separated and the NaHSO 4 is reacted with NaOH to form sodium sulfate (Na 2 SO 4 ), which is subsequently decomposed in an electrodialysis unit to form the NaOH and H 2 SO 4 components, which are used in the aforesaid reactions thereby effecting sulfur isotope separation and enrichment without objectionable loss of feed materials. (U.S.)

  19. Close to the Sky

    Science.gov (United States)

    2007-11-01

    Today, a new ALMA outreach and educational book was publicly presented to city officials of San Pedro de Atacama in Chile, as part of the celebrations of the anniversary of the Andean village. ESO PR Photo 50a/07 ESO PR Photo 50a/07 A Useful Tool for Schools Entitled "Close to the sky: Biological heritage in the ALMA area", and edited in English and Spanish by ESO in Chile, the book collects unique on-site observations of the flora and fauna of the ALMA region performed by experts commissioned to investigate it and to provide key initiatives to protect it. "I thank the ALMA project for providing us a book that will surely be a good support for the education of children and youngsters of San Pedro de Atacama. Thanks to this publication, we expect our rich flora and fauna to be better known. I invite teachers and students to take advantage of this educational resource, which will be available in our schools", commented Ms. Sandra Berna, the Mayor of San Pedro de Atacama, who was given the book by representatives of the ALMA global collaboration project. Copies of the book 'Close to the sky' will be donated to all schools in the area, as a contribution to the education of students and young people in northern Chile. "From the very beginning of the project, ALMA construction has had a firm commitment to environment and local culture, protecting unique flora and fauna species and preserving old estancias belonging to the Likan Antai culture," said Jacques Lassalle, who represented ALMA at the hand-over. "Animals like the llama, the fox or the condor do not only live in the region where ALMA is now being built, but they are also key elements of the ancient Andean constellations. In this sense they are part of the same sky that will be explored by ALMA in the near future." ESO PR Photo 50c/07 ESO PR Photo 50c/07 Presentation of the ALMA book The ALMA Project is a giant, international observatory currently under construction on the high-altitude Chajnantor site in Chile

  20. Clinical Trials

    Medline Plus

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

  1. Local media influence on opting out from an exception from informed consent trial.

    Science.gov (United States)

    Nelson, Maria J; DeIorio, Nicole M; Schmidt, Terri; Griffiths, Denise; Daya, Mohamud; Haywood, Liana; Zive, Dana; Newgard, Craig D

    2010-01-01

    News media are used for community education and notification in exception from informed consent clinical trials, yet their effectiveness as an added safeguard in such research remains unknown. We assessed the number of callers requesting opt-out bracelets after each local media report and described the errors and content within each media report. We undertook a descriptive analysis of local media trial coverage (newspaper, television, radio, and Web log) and opt-out requests during a 41-month period at a single site participating in an exception from informed consent out-of-hospital trial. Two nontrial investigators independently assessed 41 content-based media variables (including background, trial information, graphics, errors, publication information, and assessment) with a standardized, semiqualitative data collection tool. Major errors were considered serious misrepresentation of the trial purpose or protocol, whereas minor errors included misinformation unlikely to mislead the lay reader about the trial. We plotted the temporal relationship between opt-out bracelet requests and media reports. Descriptive information about the news sources and the trial coverage are presented. We collected 39 trial-related media reports (33 newspaper, 1 television, 1 radio, and 4 blogs). There were 13 errors in 9 (23%) publications, 7 of which were major and 6 minor. Of 384 requests for 710 bracelets, 310 requests (80%) occurred within 4 days after trial media coverage. Graphic timeline representation of the data suggested a close association between media reports about the trial and requests for opt-out bracelets. According to results from a single site, local media coverage for an exception from informed consent clinical trial had a substantial portion of errors and appeared closely associated with opt-out requests. Copyright 2008. Published by Mosby, Inc.

  2. Close Reading in Elementary Schools

    Science.gov (United States)

    Fisher, Douglas; Frey, Nancy

    2012-01-01

    Close reading is a recommended instructional approach to meet the challenges of teaching complex texts. But close readings are more common in high school and college than in elementary schools. In this article, we identify the components of close reading that were developed after a group of elementary school teachers observed their colleges in…

  3. Power generation method including membrane separation

    Science.gov (United States)

    Lokhandwala, Kaaeid A.

    2000-01-01

    A method for generating electric power, such as at, or close to, natural gas fields. The method includes conditioning natural gas containing C.sub.3+ hydrocarbons and/or acid gas by means of a membrane separation step. This step creates a leaner, sweeter, drier gas, which is then used as combustion fuel to run a turbine, which is in turn used for power generation.

  4. close: Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design.

    Science.gov (United States)

    Mas, Jean-Louis; Derumeaux, Geneviève; Amarenco, Pierre; Arquizan, Caroline; Aubry, Pierre; Barthelet, Martine; Bertrand, Bernard; Brochet, Eric; Cabanes, Laure; Donal, Erwan; Dubois-Randé, Jean-Luc; Durand-Zaleski, Isabelle; Ernande, Laura; Finet, Gérard; Fraisse, Alain; Giroud, Maurice; Guérin, Patrice; Habib, Gilbert; Juliard, Jean-Michel; Leys, Didier; Lièvre, Michel; Lusson, Jean-René; Marcon, François; Michel, Patrick; Moulin, Thierry; Mounier-Vehier, François; Pierard, Luc; Piot, Christophe; Rey, Christian; Rodier, Gilles; Roudaut, Raymond; Schleich, Jean-Marc; Teiger, Emmanuel; Turc, Guillaume; Vuillier, Fabrice; Weimar, Christian; Woimant, France; Chatellier, Gilles

    2016-08-01

    Currently available data do not provide definitive evidence on the comparative benefits of closure of patent foramen ovale, oral anticoagulants and antiplatelet therapy in patients with patent foramen ovale-associated cryptogenic stroke To assess whether transcatheter patent foramen ovale closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy, for secondary stroke prevention in patients aged 16 to 60 years with a large patent foramen ovale or a patent foramen ovale associated with an atrial septal aneurysm, and an otherwise unexplained ischaemic stroke or retinal ischaemia. Six hundred and sixty-four patients were included in the study. CLOSE is an academic-driven, multicentre, randomized, open-label, three-group, superiority trial with blinded adjudication of outcome events. The trial has been registered with Clinical Trials Register (Clinicaltrials.gov, NCT00562289). Patient recruitment started in December 2007. Patient follow-up will continue until December 2016. Expected mean follow-up = 5.6 years. The primary efficacy outcome is the occurrence of fatal or nonfatal stroke. Safety outcomes include fatal, life-threatening or major procedure- or device-related complications and fatal, life-threatening or major haemorrhagic complications. CLOSE is the first specifically designed trial to assess the superiority of patent foramen ovale closure over antiplatelet therapy alone and the superiority of oral anticoagulants over antiplatelet therapy to prevent stroke recurrence in patients with patent foramen ovale-associated cryptogenic stroke. © 2016 World Stroke Organization.

  5. Strategies to improve retention in randomised trials

    Science.gov (United States)

    Brueton, Valerie C; Tierney, Jayne; Stenning, Sally; Harding, Seeromanie; Meredith, Sarah; Nazareth, Irwin; Rait, Greta

    2013-01-01

    severe symptoms do not return questionnaires or attend a follow-up visit, this will bias the findings of the trial. Many methods are used by researchers to keep people in trials. These encourage people to send back data by questionnaire, return to a clinic or hospital for trial-related tests, or be seen by a health or community care worker. Study characteristics This review identified methods that encouraged people to stay in trials. We searched scientific databases for randomised studies (where people are allocated to one of two or more possible treatments in a random manner) or quasi-randomised studies (where allocation is not really random, e.g. based on date of birth, order in which they attended clinic) that compared methods of increasing retention in trials. We included trials of participants from any age, gender, ethnic, cultural, language and geographic groups. Key results The methods that appeared to work were offering or giving a small amount of money for return of a completed questionnaire and enclosing a small amount of money with a questionnaire with the promise of a further small amount of money for return of a filled in questionnaire. The effect of other ways to keep people in trials is still not clear and more research is needed to see if these really do work. Such methods are shorter questionnaires, sending questionnaires by recorded delivery, using a trial design where people know which treatment they will receive, sending specially designed letters with a reply self addressed stamped envelope followed by a number of reminders, offering a donation to charity or entry into a prize draw, sending a reminder to the study site about participants to follow-up, sending questionnaires close to the time the patient was last followed-up, managing peoples' follow-up, conducting follow-up by telephone and changing the order of questionnaire questions. Quality of evidence The methods that we identified were tested in trials run in many different disease areas and

  6. Summary and closing remarks

    International Nuclear Information System (INIS)

    Hiskes, J.R.

    1996-01-01

    A summary of the topics covered in papers presented at the 1995 Brookhaven joint conference on production, neutralization, and application of negative ion beams is given. The conference topics covered included plasma ion sources, plasma seeding of these sources for increased ion production, beam extraction and transport, computer simulation and design studies, and operation of existing and experimental ion source facilities. Application of the sources to accelerator, tokamak, and thin film deposition are discussed. (AIP) copyright 1996 American Institute of Physics

  7. A Method for Precision Closed-Loop Irrigation Using a Modified PID Control Algorithm

    Science.gov (United States)

    Goodchild, Martin; Kühn, Karl; Jenkins, Malcolm; Burek, Kazimierz; Dutton, Andrew

    2016-04-01

    The benefits of closed-loop irrigation control have been demonstrated in grower trials which show the potential for improved crop yields and resource usage. Managing water use by controlling irrigation in response to soil moisture changes to meet crop water demands is a popular approach but requires knowledge of closed-loop control practice. In theory, to obtain precise closed-loop control of a system it is necessary to characterise every component in the control loop to derive the appropriate controller parameters, i.e. proportional, integral & derivative (PID) parameters in a classic PID controller. In practice this is often difficult to achieve. Empirical methods are employed to estimate the PID parameters by observing how the system performs under open-loop conditions. In this paper we present a modified PID controller, with a constrained integral function, that delivers excellent regulation of soil moisture by supplying the appropriate amount of water to meet the needs of the plant during the diurnal cycle. Furthermore, the modified PID controller responds quickly to changes in environmental conditions, including rainfall events which can result in: controller windup, under-watering and plant stress conditions. The experimental work successfully demonstrates the functionality of a constrained integral PID controller that delivers robust and precise irrigation control. Coir substrate strawberry growing trial data is also presented illustrating soil moisture control and the ability to match water deliver to solar radiation.

  8. Pneumococcal disease: Closing the gap

    Directory of Open Access Journals (Sweden)

    Ashfaq Hasan

    2015-01-01

    Full Text Available oday, India is home to 99 million elderly people. By 2050, the number of elderly in this country will have gone up to 300 million1. With an increase in life expectancy from 32 years at the time of independence to 67.14 years in 20121, 10% of the population finds itself labeled as ‘senior citizen’. Inevitably, age brings with it comorbidities, immune senescence and pneumococcal disease. Pneumonia, in deference to its considerable morbidity and mortality, was exalted by Sir William Osler to its dubious pedestal of “Captain of all these Men of Death”. Unsurprisingly, immune debility and in several regions of the planet increasing antibiotic resistance, have ensured that pneumococcal pneumonia continues to take a large toll of senior citizens. Death rates have hardly budged over the last three decades. In India, pneumonia accounts for 25-30% deaths in the elderly3, a fatality rate almost unrivalled by most other terminal diseases. Among 15 high-burden countries, India has the dubious distinction of ranking third from last in the Global Action Plan for Pneumonia and Diarrhea (GAPPD4. During the World Immunization Week 2015 (April 24th to 30th, the ‘Close the Immunization Gap’ campaign gains crucial importance. Immunization, long vaunted as one of the most successful and cost-effective health interventions there is, prevent 2 to 3 million deaths every year, and saves enor-mous hospitalization costs and prevents loss of productivity. The recently published CAPiTA study (Community Acquired Pneumonia Immunization Trial in Adults, evaluated the efficacy of a novel 13-valent conju-gate vaccine for Pneumococcal pneumonia a vac-cine proven for its efficacy in children for the first time in older adults over 85,000 of them. Childhood vaccination with ‘PCV-13’, of course, was instrumental in reducing nasopharyngeal carriage of Strep pneumonia and decreasing the prevalence of Pneumococcal disease in the community at large. Altogether, the idea

  9. [Closed spinal dysraphism].

    Science.gov (United States)

    Bollini, G; Cottalorda, J; Jouve, J L; Labriet, C; Choux, M

    1993-04-01

    This retrospective review included 133 patients with one or several of the following defects: diastematomyelia, neurenteric cyst, dermal sinus or cyst, meningeal malformation, sacral agenesis, tethering of the spinal cord, and lumbosacral lipoma. Physical evaluation readily identified most lumbosacral lipomas, as well as most cases of diastematomyelia since hypertrichosis over the defect was common. Some patients developed life-threatening clinical manifestations, e.g., meningitis due to a dermal sinus. On the basis of this retrospective review and a review of the literature, the clinical and therapeutic aspects of each defect are discussed.

  10. Distributed Autonomous Control of Multiple Spacecraft During Close Proximity Operations

    National Research Council Canada - National Science Library

    McCamish, Shawn B

    2007-01-01

    This research contributes to multiple spacecraft control by developing an autonomous distributed control algorithm for close proximity operations of multiple spacecraft systems, including rendezvous...

  11. Ecuador project closes shop.

    Science.gov (United States)

    1985-01-01

    The US Agency for International Development (AID) has discontinued its contraceptive social marketing project in Ecuador after 2 1/2 years without a sale. USAID had awarded a 3-year US$1.2 million grant to the program's contractor, the John Snow Public Health Group Inc. The project was run by Ecuador's national family planning association. This is only the 3rd time USAID has terminated a social marketing program since entering this field in 1973. Impediments to the program's operation included product price hikes and supply shortages as a result of teh inflation and currency devaluation in Ecuador in recent years. Government opposition to the sales of donated contraceptive supplies further set back the program. The name chosen for the condom distributed by the program, Liber, had to be changed since a company importing sanitary napkins was using the name Liberty and objected. The program's peculiar organizational structur is also considered to have played a role in the program's failure. Rather than having a single authority responsible for the program, a 2-headed organizational design was used. Program funds were controlled by the contractor, but the family planning organization managed day to day operations. Unified management has enabled programs in other countries to survive problems such as inflation, brand registration, and product and price approvals.

  12. Clinical Trials

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

  13. Clinical Trials

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    Full Text Available ... doing screening tests, such as mammography; and compare two or more screening tests to see which test ... and Blood Institute (NHLBI) sponsored a trial of two different combinations of asthma treatments. The trial found ...

  14. Clinical Trials

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    Full Text Available ... clinical trials. An IRB is an independent committee created by the institution that sponsors a clinical trial. ... have not only shaped medical practice around the world, but have improved the health of millions of ...

  15. Clinical Trials

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    Full Text Available ... treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ... are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and ...

  16. Clinical Trials

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    Full Text Available ... education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, ... be identified earlier than they would be in general medical practice. This is because late-phase trials ...

  17. Clinical Trials

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    Full Text Available ... Entire Site NHLBI Entire Site Health Topics News & Resources Intramural Research ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ...

  18. Clinical Trials

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    Full Text Available ... quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines who is ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ...

  19. Clinical Trials

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    Full Text Available ... Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... and advance medical care. They also can help health care decisionmakers direct resources to the strategies and treatments ...

  20. Clinical Trials

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

  1. Clinical Trials

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    Full Text Available ... trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... they advance medical knowledge and help improve patient care. Sponsorship and Funding The National Heart, Lung, and ...

  2. Clinical Trials

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ...

  3. Clinical Trials

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    Full Text Available ... are doctors, statisticians, and community members. The IRB's purpose is to ensure that clinical trials are ethical ... enrolling in a clinical trial: What is the purpose of the study? Who is sponsoring the study, ...

  4. Clinical Trials

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    Full Text Available ... quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines who is ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

  5. Clinical Trials

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    Full Text Available ... help produce reliable study results. Clinical trials are one of the final stages of a long and ... trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of lowering ...

  6. Clinical Trials

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    Full Text Available ... best data available for health care decisionmaking. The purpose of clinical trials is research, so the studies ... Thus, research in humans is needed. For safety purposes, clinical trials start with small groups of patients ...

  7. Clinical Trials

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    Full Text Available ... providers don't always cover all patient care costs for clinical trials. If you're thinking about ... clinical trial, find out ahead of time about costs and coverage. You should learn about the risks ...

  8. Clinical Trials

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    Full Text Available ... and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...

  9. Clinical Trials

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

  10. Clinical Trials

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

  11. Clinical Trials

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    Full Text Available ... whether a new approach causes any harm. In later phases of clinical trials, researchers learn more about ... other National Institutes of Health (NIH) Institutes and Centers sponsor clinical trials. Many other groups, companies, and ...

  12. Clinical Trials

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

  13. Clinical Trials

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    Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ...

  14. Clinical Trials

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    Full Text Available ... Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s Health All Science A-Z Grants & ... or groups to help sponsor some trials. All types of clinical trials contribute to medical knowledge and ...

  15. Clinical Trials

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    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 ...

  16. Clinical Trials

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    Full Text Available ... Working at the NHLBI Contact and FAQs Accessible Search Form Search the NHLBI, use the drop down list to ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

  17. Clinical Trials

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    Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A ...

  18. Clinical Trials

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    Full Text Available ... are needed focusing on children's health with the goal to develop treatments, drugs, and devices specific to ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  19. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute of Health ...

  20. Clinical Trials

    Medline Plus

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

  1. Clinical Trials

    Medline Plus

    Full Text Available ... are research studies that explore whether a medical strategy, treatment, or device is safe and effective for ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  2. Clinical Trials

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    Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ... lung, and blood disorders. By engaging the research community and a broad group of stakeholders and advisory ...

  3. Clinical Trials

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    Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  4. Clinical Trials

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

  5. Clinical Trials

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    Full Text Available ... well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

  6. Clinical Trials

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    Full Text Available ... team also may ask you to do other tasks. For example, you may have to keep a ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  7. Clinical Trials

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    Full Text Available ... at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ... in a clinical trial, find out ahead of time about costs and coverage. You should learn about ...

  8. Clinical Trials

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    Full Text Available ... comparison groups by chance, rather than choice. This method helps ensure that any differences observed during a ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  9. Closed and Not Closed: Mitigating a Mystery on Chandra's Door

    Science.gov (United States)

    Odom, Brian

    2015-01-01

    The Chandra X-ray Observatory is part of NASA's fleet of "Great Observatories" along with the Hubble Space Telescope, the Spitzer Space Telescope, and the now deorbited Compton Gamma Ray Observatory. The observatory was designed to detect x-ray emissions from some of the hottest regions of the galaxy including exploded stars, clusters of galaxies, and matter around black holes. One of the observatory's key scientific instruments is the Advanced CCD Imaging Spectrometer (ACIS), which is one of four primary and two focal plane instruments. Due to the sensitivity of the charged coupled devices (CCD's), an aperture door was designed and built by Lockheed-Martin that protected the instrument during testing and the time leading up to launch. The design called for a system of wax actuators (manufactured by STARSYS Corp) to be used as components in a rotary actuator that would open and close the door during ground testing and on-orbit operations. Another feature of the design was an internal shear disc located in each actuator to prevent excessive internal pressure and to shield other components from damage.

  10. Key ecological challenges for closed systems facilities

    Science.gov (United States)

    Nelson, Mark; Dempster, William F.; Allen, John P.

    2013-07-01

    Closed ecological systems are desirable for a number of purposes. In space life support systems, material closure allows precious life-supporting resources to be kept inside and recycled. Closure in small biospheric systems facilitates detailed measurement of global ecological processes and biogeochemical cycles. Closed testbeds facilitate research topics which require isolation from the outside (e.g. genetically modified organisms; radioisotopes) so their ecological interactions and fluxes can be studied separate from interactions with the outside environment. But to achieve and maintain closure entails solving complex ecological challenges. These challenges include being able to handle faster cycling rates and accentuated daily and seasonal fluxes of critical life elements such as carbon dioxide, oxygen, water, macro- and mico-nutrients. The problems of achieving sustainability in closed systems for life support include how to handle atmospheric dynamics including trace gases, producing a complete human diet, recycling nutrients and maintaining soil fertility, the maintenance of healthy air and water and preventing the loss of critical elements from active circulation. In biospheric facilities, the challenge is also to produce analogues to natural biomes and ecosystems, studying processes of self-organization and adaptation in systems that allow specification or determination of state variables and cycles which may be followed through all interactions from atmosphere to soils. Other challenges include the dynamics and genetics of small populations, the psychological challenges for small isolated human groups and backup technologies and strategic options which may be necessary to ensure long-term operation of closed ecological systems.

  11. Closed forms and multi-moment maps

    DEFF Research Database (Denmark)

    Madsen, Thomas Bruun; Swann, Andrew Francis

    We extend the notion of multi-moment map to geometries defined by closed forms of arbitrary degree. We give fundamental existence and uniqueness results and discuss a number of essential examples, including geometries related to special holonomy. For forms of degree four, multi-moment maps...

  12. Closed forms and multi-moment maps

    DEFF Research Database (Denmark)

    Madsen, T. B.; Swann, A.

    2013-01-01

    We extend the notion of multi-moment map to geometries defined by closed forms of arbitrary degree. We give fundamental existence and uniqueness results and discuss a number of essential examples, including geometries related to special holonomy. For forms of degree four, multi-moment maps are gu...

  13. 75 FR 74108 - Post Office Closing

    Science.gov (United States)

    2010-11-30

    ... the closing of the Eugene Post Office's University Station in Eugene, Oregon, has been filed. It... the Eugene Post Office's University Station located in Eugene, Oregon. The petition, which was filed.... Categories of issues apparently raised. The categories of issues raised include: Failure to follow the post...

  14. Clinical Trials

    Medline Plus

    Full Text Available ... Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... for health-related questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical trials that have not only shaped medical practice around the world, but have improved the health of millions of ...

  16. Clinical Trials

    Medline Plus

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

  17. Clinical Trials

    Medline Plus

    Full Text Available ... about your health or fill out forms about how you feel. Some people will need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in Bethesda, Maryland, runs clinical trials. Many other clinical trials take place ...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... trial's results apply. These criteria also are a safety measure. They ensure a trial excludes any people for whom the protocol has known risks that outweigh any possible ... groups of people for safety and side effects. Phase II clinical trials look ...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... trial participants. Children and Clinical Studies Learn about the importance of children in clinical studies and get answers to common questions. NIH Clinical Research Trials and You Get additional guidance on participating in clinical trials at the NIH. The NHLBI conducts a large number of ...

  20. Recycling management including transportation experience

    International Nuclear Information System (INIS)

    Ricaud, J.L.

    1994-01-01

    The nuclear industry, at least in advanced countries such as Japan, France and other European countries, has developed for years a global strategy of fuel utilization which implies an extensive recycling and reuse of spent fuel. Such recycling strategies are now increasingly required from the industry in general by the various Governments and international organizations. Nuclear fuel recycling and waste management are the two faces of the same policy: the closed fuel cycle, whereby reprocessing of spent fuel makes available for recycling the energetic contents : uranium and plutonium, while segregating the real waste in categories for their specific treatment, conditioning, storage, transportation and final disposal. Plutonium recycling is performed through the fabrication of the so-called mixed oxide fuel (MOX), where fissile plutonium replaces the U 235 isotope used in UO 2 fuel. The international trade of nuclear materials and services, under close control of IAEA and other national and international organization, has let to the circulation of materials between the producers of uranium and enrichment fuel, fabrication, reprocessing and recycling services, and the customers worldwide. The industrial transport experience now accumulated shows an excellent record in terms of safety and quality. This communication will describe the current situation and future trends of the recycling route mainly through COGEMA industrial experience. 1 fig

  1. 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...

  2. 77 FR 31862 - National Center for Complementary & Alternative Medicine; Notice of Closed Meetings

    Science.gov (United States)

    2012-05-30

    ... Complementary & Alternative Medicine; Notice of Closed Meetings Pursuant to section 10(d) of the Federal... Scientific Review, National Center for Complementary and Alternative Medicine, NIH, 6707 Democracy Blvd... for Complementary and Alternative Medicine Special Emphasis Panel; HCS Collaboratory Pragmatic Trials...

  3. Systematic review and meta-analysis of closed suction drainage versus non-drainage in primary hip arthroplasty.

    LENUS (Irish Health Repository)

    Kelly, Enda G

    2014-03-01

    The routine use of drains in surgery has been dogmatically instituted in some disciplines. Orthopaedic surgery is one such sub-speciality. The use of postoperative closed suction drainage in total hip arthroplasty (THA) has become increasingly controversial with multiple randomised control trials performed to assess the benefit to outcome in THA. The hypothesis of this systematic review is that closed suction drainage does not infer a benefit and increase transfusion requirements of primary total hip arthroplasty patients. A systematic review and meta-analysis was conducted adhering to the PRISMA guidelines. A search of the available literature was performed on PubMed, Cochrane Central Registry of Controlled Trials, MEDLINE (OVID) and EMBASE using a combination of MeSH terms and Boolean operators. All data analysis was performed using the Cochrane Collaboration\\'s Review Manager 5.1. Sixteen studies (n=2705) were included in the analysis. Post-operative closed suction drainage was found to increase total blood loss and blood transfusion requirements (p<0.05). Surgical site infection demonstrated no significant difference between the two groups (p=0.82). No significant difference in haematoma formation between groups (p=0.19) was elicited. The routine use of closed suction drainage systems post primary hip arthroplasty is not supported by this meta-analysis. However, the heterogeneity between studies does limit the accuracy of the meta-analysis.

  4. An integrated approach to consumer representation and involvement in a multicentre randomized controlled trial.

    Science.gov (United States)

    Langston, Anne L; McCallum, Marilyn; Campbell, Marion K; Robertson, Clare; Ralston, Stuart H

    2005-01-01

    Although, consumer involvement in individual studies is often limited, their involvement in guiding health research is generally considered to be beneficial. This paper outlines our experiences of an integrated relationship between the organisers of a clinical trial and a consumer organisation. The PRISM trial is a UK multicentre, randomized controlled trial comparing treatment strategies for Paget's disease of the bone. The National Association for the Relief of Paget's Disease (NARPD) is the only UK support group for sufferers of Paget's disease and has worked closely with the PRISM team from the outset. NARPD involvement is integral to the conduct of the trial and specific roles have included: peer-review; trial steering committee membership; provision of advice to participants, and promotion of the trial amongst Paget's disease patients. The integrated relationship has yielded benefits to both the trial and the consumer organisation. The benefits for the trial have included: recruitment of participants via NARPD contacts; well-informed participants; unsolicited patient advocacy of the trial; and interested and pro-active collaborators. For the NARPD and Paget's disease sufferers, benefits have included: increased awareness of Paget's disease; increased access to relevant health research; increased awareness of the NARPD services; and wider transfer of diagnosis and management knowledge to/from health care professionals. Our experience has shown that an integrated approach between a trial team and a consumer organisation is worthwhile. Adoption of such an approach in other trials may yield significant improvements in recruitment and quality of participant information flow. There are, however, resource implications for both parties.

  5. Experimental simulation of closed timelike curves.

    Science.gov (United States)

    Ringbauer, Martin; Broome, Matthew A; Myers, Casey R; White, Andrew G; Ralph, Timothy C

    2014-06-19

    Closed timelike curves are among the most controversial features of modern physics. As legitimate solutions to Einstein's field equations, they allow for time travel, which instinctively seems paradoxical. However, in the quantum regime these paradoxes can be resolved, leaving closed timelike curves consistent with relativity. The study of these systems therefore provides valuable insight into nonlinearities and the emergence of causal structures in quantum mechanics--essential for any formulation of a quantum theory of gravity. Here we experimentally simulate the nonlinear behaviour of a qubit interacting unitarily with an older version of itself, addressing some of the fascinating effects that arise in systems traversing a closed timelike curve. These include perfect discrimination of non-orthogonal states and, most intriguingly, the ability to distinguish nominally equivalent ways of preparing pure quantum states. Finally, we examine the dependence of these effects on the initial qubit state, the form of the unitary interaction and the influence of decoherence.

  6. Mappings with closed range and compactness

    International Nuclear Information System (INIS)

    Iyahen, S.O.; Umweni, I.

    1985-12-01

    The motivation for this note is the result of E.O. Thorp that a normed linear space E is finite dimensional if and only if every continuous linear map for E into any normed linear space has a closed range. Here, a class of Hausdorff topological groups is introduced; called r-compactifiable topological groups, they include compact groups, locally compact Abelian groups and locally convex linear topological spaces. It is proved that a group in this class which is separable, complete metrizable or locally compact, is necessarily compact if its image by a continuous group homomorphism is necessarily closed. It is deduced then that a Hausdorff locally convex is zero if its image by a continuous additive map is necessarily closed. (author)

  7. Potential Risks and Mitigation Strategies During the Conduct of a Clinical Trial: An Industry Perspective.

    Science.gov (United States)

    Bhagat, Seema; Kapatkar, Vaibhavi; Katare, Sagar; Mane, Ashish; Pinto, Colette; Pawar, Kedar; Shah, Agam; Barkate, Hanmant

    2018-01-31

    Every phase of a clinical trial should be designed in compliance with good clinical practices by following all relevant regulatory guidelines. Patient safety, data integrity and ethics are an integral part of a successful clinical trial which must be considered. Therefore, risk monitoring is an essential tool to identify the risks associated with conduct of any trial. This article is a result of extensive research conducted by a reputed pharmaceutical company to identify the potential stages of risks associated with the conduct phase of trial that could impact the overall quality and safety of a trial. The skillful and experienced team members of a reputed pharmaceutical company involved in conducting clinical trials underwent brainstorming sessions to assess and categorize the risks associated with each stage of conduct phase of a clinical trial. They also developed a mitigation plan based on their experiences, best practices and applicable guidance documents. During conduct phase, risks are associated with preparation of site master and trial master file, courier of study supply to site(s) including investigational product prior to site initiation visit, patient recruitment, telephonic monitoring, adverse or serious adverse event monitoring, site monitoring visit(s), collected case report form pages forward to data management vendor, data query clarification and site close-out visit. A close working relationship with all the persons associated with the clinical trial, timely monitoring and prospective mitigation planning is required for the conduct of a high quality trial. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  8. Closed suction drainage for hip and knee arthroplasty. A meta-analysis.

    Science.gov (United States)

    Parker, Martyn J; Roberts, Chris P; Hay, Douglas

    2004-06-01

    The use of closed-suction drainage systems after total joint replacement is a common practice. The theoretical advantages for the use of drains is a reduction in the occurrence of wound hematomas and infection. The aim of this meta-analysis was to determine, on the basis of the evidence from randomized controlled trials, the advantages and adverse effects of surgical drains. All randomized trials, as far as we know, that compared patients managed with closed-suction drainage systems and those managed without a drain following elective hip and knee arthroplasty were considered. The trials were identified with use of searches of the Cochrane Collaboration with no restriction on languages or source. Two authors independently extracted the data, and the methods of all identified trials were assessed. Eighteen studies involving 3495 patients with 3689 wounds were included in the analysis. The pooled results indicated that there was no significant difference between the wounds treated with a drain and those treated without a drain with respect to the occurrence of wound infection (relative risk, 0.73; 95% confidence interval, 0.47 to 1.14), wound hematoma (relative risk, 1.73; 95% confidence interval, 0.74 to 4.07), or reoperations for wound complications (relative risk, 0.52; 95% confidence interval, 0.13 to 1.99). A drained wound was associated with a significantly greater need for transfusion (relative risk, 1.43; 95% confidence interval, 1.19 to 1.72). Reinforcement of wound dressings was required more frequently in the group managed without drains. No difference between the groups was seen with respect to limb-swelling, venous thrombosis, or hospital stay. Studies to date have indicated that closed suction drainage increases the transfusion requirements after elective hip and knee arthroplasty and has no major benefits. Further randomized trials with use of larger numbers of patients with full reporting of outcomes are indicated before the absence of any benefit

  9. Prospective Evaluation of Magnetic Resonance Imaging and [18F]Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography at Diagnosis and Before Maintenance Therapy in Symptomatic Patients With Multiple Myeloma Included in the IFM/DFCI 2009 Trial: Results of the IMAJEM Study.

    Science.gov (United States)

    Moreau, Philippe; Attal, Michel; Caillot, Denis; Macro, Margaret; Karlin, Lionel; Garderet, Laurent; Facon, Thierry; Benboubker, Lotfi; Escoffre-Barbe, Martine; Stoppa, Anne-Marie; Laribi, Kamel; Hulin, Cyrille; Perrot, Aurore; Marit, Gerald; Eveillard, Jean-Richard; Caillon, Florence; Bodet-Milin, Caroline; Pegourie, Brigitte; Dorvaux, Veronique; Chaleteix, Carine; Anderson, Kenneth; Richardson, Paul; Munshi, Nikhil C; Avet-Loiseau, Herve; Gaultier, Aurelie; Nguyen, Jean-Michel; Dupas, Benoit; Frampas, Eric; Kraeber-Bodere, Françoise

    2017-09-01

    Purpose Magnetic resonance imaging (MRI) and positron emission tomography-computed tomography (PET-CT) are important imaging techniques in multiple myeloma (MM). We conducted a prospective trial in patients with MM aimed at comparing MRI and PET-CT with respect to the detection of bone lesions at diagnosis and the prognostic value of the techniques. Patients and Methods One hundred thirty-four patients received a combination of lenalidomide, bortezomib, and dexamethasone (RVD) with or without autologous stem-cell transplantation, followed by lenalidomide maintenance. PET-CT and MRI were performed at diagnosis, after three cycles of RVD, and before maintenance therapy. The primary end point was the detection of bone lesions at diagnosis by MRI versus PET-CT. Secondary end points included the prognostic impact of MRI and PET-CT regarding progression-free (PFS) and overall survival (OS). Results At diagnosis, MRI results were positive in 127 of 134 patients (95%), and PET-CT results were positive in 122 of 134 patients (91%; P = .33). Normalization of MRI after three cycles of RVD and before maintenance was not predictive of PFS or OS. PET-CT became normal after three cycles of RVD in 32% of the patients with a positive evaluation at baseline, and PFS was improved in this group (30-month PFS, 78.7% v 56.8%, respectively). PET-CT normalization before maintenance was described in 62% of the patients who were positive at baseline. This was associated with better PFS and OS. Extramedullary disease at diagnosis was an independent prognostic factor for PFS and OS, whereas PET-CT normalization before maintenance was an independent prognostic factor for PFS. Conclusion There is no difference in the detection of bone lesions at diagnosis when comparing PET-CT and MRI. PET-CT is a powerful tool to evaluate the prognosis of de novo myeloma.

  10. BLM Colorado Mining Claims Closed

    Data.gov (United States)

    Department of the Interior — Shapefile Format –This data set consists of closed mining claim records extracted from BLM’s LR2000 database. These records contain case attributes as well as legal...

  11. Pollution hazard closes neutrino lab

    CERN Multimedia

    Jones, Nicola

    2003-01-01

    "A leading astrophysics laboratory in Italy has closed down all but one of its experiments over concerns that toxic polluants could leak form the underground lab into the local water supply" (0.5 page)

  12. 77 FR 59405 - National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings

    Science.gov (United States)

    2012-09-27

    ... Deafness and Other Communication Disorders; Notice of Closed Meetings Pursuant to section 10(d) of the... Deafness and Other Communication Disorders Special Emphasis Panel; Hearing--Clinical Trials & Translational... Other Communication Disorders Special Emphasis Panel; Vestibular--Clinical Trials. Date: October 23...

  13. Stem cells in clinical trials for treatment of retinal degeneration.

    Science.gov (United States)

    Klassen, Henry

    2016-01-01

    After decades of basic science research involving the testing of regenerative strategies in animal models of retinal degenerative diseases, a number of clinical trials are now underway, with additional trials set to begin shortly. These efforts will evaluate the safety and preliminary efficacy of cell-based products in the eyes of patients with a number of retinal conditions, notably including age-related macular degeneration, retinitis pigmentosa and Stargardt's disease. This review considers the scientific work and early trials with fetal cells and tissues that set the stage for the current clinical investigatory work, as well the trials themselves, specifically those either now completed, underway or close to initiation. The cells of interest include retinal pigment epithelial cells derived from embryonic stem or induced pluripotent stem cells, undifferentiated neural or retinal progenitors or cells from the vascular/bone marrow compartment or umbilical cord tissue. Degenerative diseases of the retina represent a popular target for emerging cell-based therapeutics and initial data from early stage clinical trials suggest that short-term safety objectives can be met in at least some cases. The question of efficacy will require additional time and testing to be adequately resolved.

  14. 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 each...... relating to obsolescence, fidelity of intervention delivery, and adherence and crossover. Assessment and analysis raise questions regarding blinding and clustering of observations. This paper describes methodological problems in the design and conduct of surgical randomized trials and proposes strategies...

  15. Alien wavelength modeling tool and field trial

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  16. SAPHO: Treatment options including bisphosphonates.

    Science.gov (United States)

    Zwaenepoel, Tom; Vlam, Kurt de

    2016-10-01

    Both the diagnosis and treatment of the syndrome of synovitis, acne, pustulosis, hyperostosis, osteitis (SAPHO) remain difficult. We describe a case series of 21 patients with SAPHO and their response to several pharmacological treatments. Clinical and biochemical data, along with medical imaging, were collected from the medical records of 21 patients, diagnosed as SAPHO during follow-up between 2005 and 2013. Symptoms and inflammatory markers were recorded twice, once at first patient presentation, and once at the end of follow-up. Synovitis, acne, pustulosis, hyperostosis, and osteitis were labeled as defining features. All treatment options were categorized according to their respective responses (full remission, partial remission, and no disease control). There was a female predominance and a median age of 32 years (range: 12-54 years). Median follow-up duration was 45 months (range: 0-188 months). Total prevalence of defining features in this cohort increased for each defining feature during follow-up, except for acne. All patients reached full or partial remission at the end of follow-up. A total of 14 patients were treated with bisphosphonates. Of which 8 of them went into full or partial remission. In our case series, none of the patients had the full presentation of SAPHO at the first consultation. Some presented with symptoms suggestive for psoriatic arthritis. This explains why diagnosis of SAPHO can be challenging. Full remission was induced in the majority of individuals. Bisphosphonates seem to be a noteworthy treatment option. We suggest a prospective placebo-controlled clinical trial with bisphosphonates to confirm this observation. Copyright © 2016. Published by Elsevier Inc.

  17. Update on TROG trials

    International Nuclear Information System (INIS)

    Joseph, D.

    2001-01-01

    Full text: Validation of treatment methodologies can only be achieved in the context of unambiguous, efficiently managed, randomised and controlled clinical trials. Since 1991, the Trans-Tasman Radiation Oncology Group (TROG) has coordinated over 29 protocols in radiation oncology, including several key randomised controlled trials. The impetus behind TROG is the establishment of an evidence base for particular approaches to radiotherapy and its adjunct use with alternative and complementary treatment methods. As the level of technology incorporated into radiotherapy continues to increase, as the need for improved accuracy in dose assessment increases and as the requirements of realistic quality assurance (QA) for clinical trials becomes more demanding it is imperative that all professionals involved in radiotherapy, including physicists, become actively involved in the QA of trials. This is particularly important for large scale multi-centre trials which intend to prove the benefits of particular treatment approaches on a national or international stage rather then in the context of a single clinic. This talk will: 1. Examine the outcomes of TROG trials to date in terms of the information obtained. 2. Briefly consider current and impending TROG trials and their requirements in terms of clinical and physics input. 3. Examine the results of international clinical trials in terms of the influence they have had on radiotherapy practice and health outcomes, and the advantages they have obtained by consistent co-operation between clinical and technological staff. 4. Consider the benefits of multi-centre clinical trials and the QA controls that are necessary to ensure accuracy of resulting recommendations. Copyright (2001) Australasian College of Physical Scientists and Engineers in Medicine

  18. Musculoskeletal ultrasound including definitions for ultrasonographic pathology

    DEFF Research Database (Denmark)

    Wakefield, RJ; Balint, PV; Szkudlarek, Marcin

    2005-01-01

    Ultrasound (US) has great potential as an outcome in rheumatoid arthritis trials for detecting bone erosions, synovitis, tendon disease, and enthesopathy. It has a number of distinct advantages over magnetic resonance imaging, including good patient tolerability and ability to scan multiple joints...... in a short period of time. However, there are scarce data regarding its validity, reproducibility, and responsiveness to change, making interpretation and comparison of studies difficult. In particular, there are limited data describing standardized scanning methodology and standardized definitions of US...... pathologies. This article presents the first report from the OMERACT ultrasound special interest group, which has compared US against the criteria of the OMERACT filter. Also proposed for the first time are consensus US definitions for common pathological lesions seen in patients with inflammatory arthritis....

  19. Transmission ellipsometry on unsupported film/pellicle: closed-form inversion

    Science.gov (United States)

    Zaghloul, A. R. M.; Elshazly-Zaghloul, M.; Zaghloul, Y. A.

    2007-09-01

    We present a brief discussion of the transmission ellipsometric function of an unsupported film/pellicle optical structure. We also briefly discuss different ellipsometric techniques that could be used to characterize an unsupported film/pellicle. The current state of data reduction either uses forward curve-fitting techniques or other numerical methods to obtain the refractive index of the optical slab and its thickness. Both methods are dependent on a good starting point and use an iterative approach to minimize a merit function that consumes much valuable time and memory resources. We present closed-form formulas to obtain both the refractive index and thickness. We spare the reader successive and involved transformations and algebraic manipulations to arrive at the closed forms. We provide the reader with an easy-to- follow step-by-step algorithm to obtain the system parameters. Also, we present a closed-form formula for the refractive index using two, and more, sets of measurements. In addition, we discuss the effect of film-thickness multiplicity and its separation. Other technique-specific closed-form formulas are given for different ellipsometric techniques. We also present numerical simulation results that prove the accuracy of the closed-form formulas, and that revealed an interesting and useful characteristic that we utilize. We close by introducing a closed-form formula to calculate the ratio of the unsupported film/pellicle to that of the ambient, which could be used to determine either experimentally. The advantages of closed-form inversion over forward curve fitting and numerical methods are numerous, including: 1) a much higher speed of obtaining the problem solution that allows for real-time applications, 2) it does not require human judgments or intervention, 3) absolute stability, 4) much higher accuracy, 5) no need for close-to-solution starting values of the unknown parameter(s), 6) no errors introduced by the formulas themselves, 7) smart

  20. 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 ...

  1. Closed-Circuit TV Surveillance Evaluation

    Science.gov (United States)

    2010-12-01

    les tendances, l’évolution de la criminalité, les changements externes imprévus qui ont pu influer sur les résultats, les mesures d’atténuation...control room management were assessed, including working relationships with external agencies such as the police. Overall, they concluded in their report...provided by TPS in e-mail exchanges. As a component of their comprehensive crime management strategy, based on existing research into the use of Closed

  2. Reflection effect in close binary systems

    International Nuclear Information System (INIS)

    Vanlandingham, F.G.

    1974-01-01

    The investigation studies the effects of the irradiation of the hotter component in a close binary system on the atmosphere of the secondary and on the observed flux distribution of the binary system. An existing model atmospheres computer program is modified to include the effects of non-zero incident radiation. Computations reveal that the irradiation can significantly raise the temperature in the upper layers of the atmosphere. (U.S.)

  3. Quality and clinical supply considerations of Paediatric Investigation Plans for IV preparations-A case study with the FP7 CloSed project.

    Science.gov (United States)

    Hanning, Sara M; Orlu Gul, Mine; Winslade, Jackie; Baarslag, Manuel A; Neubert, Antje; Tuleu, Catherine

    2016-09-25

    A Paediatric Investigation Plan (PIP) is a development plan that aims to ensure that sufficient data are obtained through studies in paediatrics to support the generation of marketing authorisation of medicines for children. This paper highlights some practical considerations and challenges with respect to PIP submissions and paediatric clinical trials during the pharmaceutical development phase, using the FP7-funded Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit (CloSed) project as a case study. Examples discussed include challenges and considerations regarding formulation development, blinding and randomisation, product labelling and shipment and clinical trial requirements versus requirements for marketing authorisation. A significant quantity of information is required for PIP submissions and it is hoped that future applicants may benefit from an insight into some critical considerations and challenges faced in the CloSed project. Copyright © 2016 Elsevier B.V. All rights reserved.

  4. Clinical Trials

    Medline Plus

    Full Text Available ... III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists of a group of research and study topic experts. The NIH also requires DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH ...

  5. Clinical Trials

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    Full Text Available ... phase II clinical trials. The risk of side effects might be even greater for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health care providers don't always ...

  6. Clinical Trials

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    Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A DSMB's ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start ... more about the new approach's risks and benefits. A clinical trial ...

  8. Clinical Trials

    Medline Plus

    Full Text Available ... NIH also requires DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH requires DSMBs for some earlier phase trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A DSMB's ...

  9. Crafting Creative Nonfiction: From Close Reading to Close Writing

    Science.gov (United States)

    Dollins, Cynthia A.

    2016-01-01

    A process writing project in a third-grade classroom explored the idea of using nonfiction mentor texts to assist students in writing their own creative informational texts about animals. By looking at author craft and structure during close reading activities with nonfiction Twin Texts, students were taught how to emulate these techniques in…

  10. (including travel dates) Proposed itinerary

    Indian Academy of Sciences (India)

    Ashok

    31 July to 22 August 2012 (including travel dates). Proposed itinerary: Arrival in Bangalore on 1 August. 1-5 August: Bangalore, Karnataka. Suggested institutions: Indian Institute of Science, Bangalore. St Johns Medical College & Hospital, Bangalore. Jawaharlal Nehru Centre, Bangalore. 6-8 August: Chennai, TN.

  11. Cold atoms close to surfaces

    DEFF Research Database (Denmark)

    Krüger, Peter; Wildermuth, Stephan; Hofferberth, Sebastian

    2005-01-01

    Microscopic atom optical devices integrated on atom chips allow to precisely control and manipulate ultra-cold (T atoms and Bose-Einstein condensates (BECs) close to surfaces. The relevant energy scale of a BEC is extremely small (down to ... be utilized as a sensor for variations of the potential energy of the atoms close to the surface. Here we describe how to use trapped atoms as a measurement device and analyze the performance and flexibility of the field sensor. We demonstrate microscopic magnetic imaging with simultaneous high spatial...... variations of the current flow direction, resulting from local properties of the wire. These disorder potentials found near lithographically fabricated wires are two orders of magnitude smaller than those measured close to electroplated conductors....

  12. Opinion Evolution in Closed Community

    Science.gov (United States)

    Sznajd-Weron, Katarzyna; Sznajd, Józef

    A simple Ising spin model which can describe a mechanism of making a decision in a closed community is proposed. It is shown via standard Monte Carlo simulations that very simple rules lead to rather complicated dynamics and to a power law in the decision time distribution. It is found that a closed community has to evolve either to a dictatorship or a stalemate state (inability to take any common decision). A common decision can be taken in a ``democratic way'' only by an open community.

  13. Closed sets of nonlocal correlations

    International Nuclear Information System (INIS)

    Allcock, Jonathan; Linden, Noah; Brunner, Nicolas; Popescu, Sandu; Skrzypczyk, Paul; Vertesi, Tamas

    2009-01-01

    We present a fundamental concept - closed sets of correlations - for studying nonlocal correlations. We argue that sets of correlations corresponding to information-theoretic principles, or more generally to consistent physical theories, must be closed under a natural set of operations. Hence, studying the closure of sets of correlations gives insight into which information-theoretic principles are genuinely different, and which are ultimately equivalent. This concept also has implications for understanding why quantum nonlocality is limited, and for finding constraints on physical theories beyond quantum mechanics.

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

  15. Malignant lymphomas (including myeloproliferative disorders)

    International Nuclear Information System (INIS)

    Todd, I.D.H.

    1985-01-01

    This chapter deals with the radiotherapy and cytotoxic chemotherapy of the malignant lymphomas. Included within this group are Hodgkin's disease, non-Hodgkin's lymphoma, mycosis fungoides, and chronic lymphatic leukaemia. A further section deals with the myeloproliferative disorders, including granulocytic leukaemia, polycythaemia vera, and primary thrombocythaemia. Excluded are myeloma and reticulum cell sarcoma of bone and acute leukaemia. With regard to Hodgkin's disease, the past 25 years have seen general recognition of the curative potential of radiotherapy, at least in the local stages, and, more recently, awareness of the ability to achieve long-term survival after combination chemotherapy in generalised or in recurrent disease. At the same time the importance of staging has become appreciated and the introduction of procedures such as lymphography, staging laparotomy, and computer tomography (CT) has enormously increased its reliability. Advances have not been so dramatic in the complex group of non-Hodgkins's lymphomas, but are still very real

  16. Physical Activity Capture Technology With Potential for Incorporation Into Closed-Loop Control for Type 1 Diabetes.

    Science.gov (United States)

    Dadlani, Vikash; Levine, James A; McCrady-Spitzer, Shelly K; Dassau, Eyal; Kudva, Yogish C

    2015-10-18

    Physical activity is an important determinant of glucose variability in type 1 diabetes (T1D). It has been incorporated as a nonglucose input into closed-loop control (CLC) protocols for T1D during the last 4 years mainly by 3 research groups in single center based controlled clinical trials involving a maximum of 18 subjects in any 1 study. Although physical activity data capture may have clinical benefit in patients with T1D by impacting cardiovascular fitness and optimal body weight achievement and maintenance, limited number of such studies have been conducted to date. Clinical trial registries provide information about a single small sample size 2 center prospective study incorporating physical activity data input to modulate closed-loop control in T1D that are seeking to build on prior studies. We expect an increase in such studies especially since the NIH has expanded support of this type of research with additional grants starting in the second half of 2015. Studies (1) involving patients with other disorders that have lasted 12 weeks or longer and tracked physical activity and (2) including both aerobic and resistance activity may offer insights about the user experience and device optimization even as single input CLC heads into real-world clinical trials over the next few years and nonglucose input is introduced as the next advance. © 2015 Diabetes Technology Society.

  17. Noncommutative via closed star product

    Science.gov (United States)

    Kupriyanov, V. G.; Vitale, P.

    2015-08-01

    We consider linear star products on of Lie algebra type. First we derive the closed formula for the polydifferential representation of the corresponding Lie algebra generators. Using this representation we define the Weyl star product on the dual of the Lie algebra. Then we construct a gauge operator relating the Weyl star product with the one which is closed with respect to some trace functional, Tr ( f ⋆ g) = Tr ( f · g). We introduce the derivative operator on the algebra of the closed star product and show that the corresponding Leibniz rule holds true up to a total derivative. As a particular example we study the space R {/θ 3} with type noncommutativity and show that in this case the closed star product is the one obtained from the Duflo quantization map. As a result a Laplacian can be defined such that its commutative limit reproduces the ordinary commutative one. The deformed Leibniz rule is applied to scalar field theory to derive conservation laws and the corresponding noncommutative currents.

  18. Closing the Loop with Exercises

    Science.gov (United States)

    Altizer, Andy

    2008-01-01

    Conducting exercises provides a critical bridge between the theory of an Emergency Action Plan and its effective implementation. When conducted properly, exercises can fill the gap between training and after-action review to close the preparedness loop--before an actual emergency occurs. Often exercises are planned and conducted on campus based on…

  19. Works close to gate B

    CERN Document Server

    GS Department

    2011-01-01

    In connection to the TRAM project, drainage works will be carried out close to gate B until the end of next week. In order to avoid access problems, if arriving by car, please use gates A and E. Department of General Infrastructure Services (GS) GS-SE Group

  20. Changing closed agricultural policy communities

    NARCIS (Netherlands)

    Termeer, C.J.A.M.; Werkman, R.A.

    2011-01-01

    Agricultural policy networks have served as classic examples of closed policy communities facing pressure to open up. However, attempts to change them are slowly moving forward. The dialogues on Common Agricultural Policy reforms in which the Dutch Ministry of Agriculture is engaged with a range of

  1. Opening up closed policy communities.

    NARCIS (Netherlands)

    Termeer, C.J.A.M.; Werkman, R.A.

    2010-01-01

    Agricultural policy networks have served as classic cases of closed policy communities, facing pressure to open up. However attempts to involve new stakeholders slowly move forward. This paper addresses the question why it is so difficult to open up agricultural communities and what might help to

  2. Closed-Loop Neuromorphic Benchmarks

    Directory of Open Access Journals (Sweden)

    Terrence C Stewart

    2015-12-01

    Full Text Available Evaluating the effectiveness and performance of neuromorphic hardware is difficult. It is evenmore difficult when the task of interest is a closed-loop task; that is, a task where the outputfrom the neuromorphic hardware affects some environment, which then in turn affects thehardware’s future input. However, closed-loop situations are one of the primary potential uses ofneuromorphic hardware. To address this, we present a methodology for generating closed-loopbenchmarks that makes use of a hybrid of real physical embodiment and a type of minimalsimulation. Minimal simulation has been shown to lead to robust real-world performance, whilestill maintaining the practical advantages of simulation, such as making it easy for the samebenchmark to be used by many researchers. This method is flexible enough to allow researchersto explicitly modify the benchmarks to identify specific task domains where particular hardwareexcels. To demonstrate the method, we present a set of novel benchmarks that focus on motorcontrol for an arbitrary system with unknown external forces. Using these benchmarks, we showthat an error-driven learning rule can consistently improve motor control performance across arandomly generated family of closed-loop simulations, even when there are up to 15 interactingjoints to be controlled.

  3. Learning from Exhibitions: Chuck Close.

    Science.gov (United States)

    Johnson, Mark M.

    1998-01-01

    Discusses the artwork of Chuck Close, who is well known for his over-sized portraits of fellow artists and anonymous sitters, and the exhibition of his work that premiered at New York's Museum of Modern Art before traveling to other cities in the United States. (CMK)

  4. Brookhaven leak reactor to close

    CERN Multimedia

    MacIlwain, C

    1999-01-01

    The DOE has announced that the High Flux Beam Reactor at Brookhaven is to close for good. Though the news was not unexpected researchers were angry the decision had been taken before the review to assess the impact of reopening the reactor had been concluded (1 page).

  5. Exploring barriers and facilitators to clinical trial enrollment in the context of sickle cell anemia and hydroxyurea.

    Science.gov (United States)

    Lebensburger, Jeffrey D; Sidonio, Robert F; Debaun, Michael R; Safford, Monika M; Howard, Thomas H; Scarinci, Isabel C

    2013-08-01

    Several sickle cell clinical trials have closed due to inability to enroll patients. To limit the early cessation of a proposed clinical trial due to low accrual rates, we sought to better understand barriers and facilitators to enrolling parents of children with sickle cell anemia (SCD) into clinical trials. Focus groups (n = 3) were conducted with parents/guardians (n = 14) who had not previously been recruited for a clinical trial and were not administering hydroxyurea to their children. Three main themes related to barriers to clinical trial enrollment were identified during analysis of focus groups: general barriers to health related research (general mistrust of research studies, emotional and practical concerns), barriers to trial design (randomization), and barriers to hydroxyurea (long term unknown risks, cancer, myelosuppressive effects). Facilitators identified were need for more education, including request for peer education, and improved explanation of clinical trials or study rationale. Engagement of parents/guardians of children with SCD in identifying barriers and facilitators to clinical trial enrollment may be critical to the development of strategies to enhance SCD trial completion. Copyright © 2013 Wiley Periodicals, Inc.

  6. 21 CFR 11.10 - Controls for closed systems.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Controls for closed systems. 11.10 Section 11.10... RECORDS; ELECTRONIC SIGNATURES Electronic Records § 11.10 Controls for closed systems. Persons who use.... Such procedures and controls shall include the following: (a) Validation of systems to ensure accuracy...

  7. Device including a contact detector

    DEFF Research Database (Denmark)

    2011-01-01

    The present invention relates to a probe for determining an electrical property of an area of a surface of a test sample, the probe is intended to be in a specific orientation relative to the test sample. The probe may comprise a supporting body defining a first surface. A plurality of cantilever...... of cantilever arms (12) contacting the surface of the test sample when performing the movement....... arms (12) may extend from the supporting body in co-planar relationship with the first surface. The plurality of cantilever arms (12) may extend substantially parallel to each other and each of the plurality of cantilever arms (12) may include an electrical conductive tip for contacting the area...

  8. Pressure tube rupture in a closed tank

    International Nuclear Information System (INIS)

    Khater, H.A.; Hadaller, G.I.; Stern, F.

    1985-06-01

    A study has been prepared on the feasibility of conducting pressure tube/calandria tube rupture tests in a closed tank, simulating a scaled-down calandria vessel. The study includes: i) a review of previous work, ii) an analytical investigation of the scaling problem of the calandria vessel and relevant in-core structures, iii) selection of a method for initiating pressure tube/calandria tube rupture, iv) a set of specifications for the test assembly, v) general arrangement drawings, vi) a proposal for a test matrix, vii) a survey and evaluation of existing facilities which could provide the required high pressure, temperature and fluid inventory, and viii) a cost estimate for the detailed design and construction, instrumentation, data acquisition and reduction, testing and reporting. The study concludes that it is both technically and practically feasible to conduct pressure tube rupture tests in a closed tank

  9. Why Closely Coupled Work Matters in Global Software Development

    DEFF Research Database (Denmark)

    Jensen, Rasmus Eskild

    2014-01-01

    We report on an ethnographic study of an offshore global software development project between Danish and Philippine developers in a Danish company called GlobalSoft. We investigate why the IT- developers chose to engage in more closely coupled work as the project progressed and argue that closely...... coupled work supported the collaboration in a very challenging project. Three key findings are presented: 1) Closely coupled work practices established connections across the collaboration ensuring knowledge exchange and improving coordination between project members, 2) Closely coupled work practices...... the project members could better anticipate issues and act accordingly. The implications of these findings include a reconsideration of the significance of closely coupled work in distributed settings. Also our findings open up discussions of why closely coupled work matters in global software development....

  10. Clinical Trials

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    Full Text Available ... involve animal testing. This shows how the approach affects a living body and whether it's harmful. However, ... or other factors not related to the protocol affect the trial's results. Comparison Groups In most clinical ...

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    Full Text Available ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the ... part in the study? How might this trial affect my daily life? Will I have to be ...

  12. Clinical Trials

    Science.gov (United States)

    ... of Personal Stories Peers Celebrating Art Peers Celebrating Music Be Vocal Support Locator DBSA In-Person Support ... by participating in a clinical trial is to science first and to the patient second. More About ...

  13. Clinical Trials

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    Full Text Available ... issues arise. Participation and Eligibility Each clinical trial defines who is eligible to take part in the ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the ...

  14. Clinical Trials

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    Full Text Available ... symptoms. It also was increasingly being used for prevention of heart disease.) The study found that HT ... enroll healthy people to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial ...

  15. Clinical Trials

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    Full Text Available ... long and careful research process. The process often begins in a laboratory (lab), where scientists first develop ... IRB reviews the trial's protocol before the study begins. An IRB will only approve research that deals ...

  16. Clinical Trials

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    Full Text Available ... the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ... based on what is known to work in adults. To improve clinical care of children, more studies ...

  17. Clinical Trials

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    Full Text Available ... small groups of people for safety and side effects. Phase II clinical trials look at how well ... confirm how well treatments work, further examine side effects, and compare new treatments with other available treatments. ...

  18. Clinical Trials

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    Full Text Available ... States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews applications for new medicines ...

  19. Clinical Trials

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    Full Text Available ... benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials ... treatment is or how well it works. Children (aged 18 and younger) get special protection as research ...

  20. Clinical Trials

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    Full Text Available ... are ethical and that the participants' rights are protected. The IRB reviews the trial's protocol before the ... may know about studies going on in your area. You can visit the following website to learn ...

  1. Clinical Trials

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    Full Text Available ... the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in ... trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health ...

  2. Clinical Trials

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    Full Text Available ... as gene therapy or new biological treatments. Health insurance and health care providers don't always cover ... study? How might this trial affect my daily life? Will I have to be in the hospital? ...

  3. Clinical Trials

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    Full Text Available ... always, parents must give legal consent for their child to take part in a clinical trial. When ... minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  4. Clinical Trials

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    Full Text Available ... Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s ... always, parents must give legal consent for their child to take part in a clinical trial. When ...

  5. Clinical Trials

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    Full Text Available ... Usually, a computer program makes the group assignments. Masking The term "masking" refers to not telling the clinical trial participants which treatment they're getting. Masking, or "blinding," helps avoid bias. For this reason, ...

  6. Clinical Trials

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    Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug ... life? Will I have to be in the hospital? How long will the trial last? Who will ...

  7. Clinical Trials

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    Full Text Available ... participants. Children and Clinical Studies Learn about the importance of children in clinical studies and get answers to common questions. NIH Clinical Research Trials and You Get additional guidance on participating ...

  8. Clinical Trials

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

  9. Clinical Trials

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    Full Text Available ... Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s Health All Science A- ... assumed that trial results were valid for other populations as well. Researchers now realize that women and ...

  10. Clinical Trials

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    Full Text Available ... as gene therapy) or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial for safety problems or differences in results among different groups. The DSMB also reviews research results ...

  11. Clinical Trials

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    Full Text Available ... as gene therapy or new biological treatments. Health insurance and health care providers don't always cover ... oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews applications for ...

  12. Clinical Trials

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    Full Text Available ... harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits. ... Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance of ...

  13. Clinical Trials

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    Full Text Available ... Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT was already in common use for the treatment of menopausal symptoms. It also ...

  14. Clinical Trials

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    Full Text Available ... seems promising, the next step may involve animal testing. This shows how the approach affects a living ... FDA) provides oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews ...

  15. Clinical Trials

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    Full Text Available ... combination of estrogen and progestin, the risk of breast cancer also increased. As a result, the U.S. Food ... healthy people to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants ...

  16. Clinical Trials

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    Full Text Available ... Form Search the NHLBI, use the drop down list to select: the entire site, the Health Topics ... specific trials you're interested in. For a list of questions to ask your doctor and the ...

  17. Clinical Trials

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    Full Text Available ... you to explore NIH Clinical Center for patient recruitment and clinical trial information. For more information, please email the NIH Clinical Center Office of Patient Recruitment at cc-prpl@cc.nih.gov or call ...

  18. Clinical Trials

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    Full Text Available ... IRB is an independent committee created by the institution that sponsors a clinical trial. IRB members are ... provide guidance and oversight to the IRBs, develop educational programs and materials, and offer advice on research- ...

  19. Clinical Trials

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    Full Text Available ... work best for certain illnesses or groups of people. Clinical trials produce the best data available for ... or animals doesn't always work well in people. Thus, research in humans is needed. For safety ...

  20. Clinical Trials

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

  1. Clinical Trials

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    Full Text Available ... sponsor clinical trials that test the safety of products, such as medicines, and how well they work. ... placebo (plah-SE-bo). This is an inactive product that looks like the test product. You'll ...

  2. Clinical Trials

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    Full Text Available ... or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and ... in clinical trials at the NIH. The NHLBI conducts a large number of research studies at the ...

  3. Clinical Trials

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    Full Text Available ... Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often ... or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ...

  4. Clinical Trials

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    Full Text Available ... medical centers and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain access to new ...

  5. Clinical Trials

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    Full Text Available ... risk of heart disease in the first few years, and HT also increased the risk of stroke ... master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The ...

  6. Clinical Trials

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    Full Text Available ... materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists ...

  7. Clinical Trials

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    Full Text Available ... quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines who is ... Learn More Connect With Us Contact Us Directly Policies Privacy Policy Freedom of Information Act (FOIA) Accessibility ...

  8. Clinical Trials

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    Full Text Available ... trials optimization . Building 31 31 Center Drive Bethesda, MD 20892 Learn more about getting to NIH Get ... and Funding Building 31 31 Center Drive Bethesda, MD 20892 Learn more about getting to NIH Connect ...

  9. Clinical Trials

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    Full Text Available ... get special protection as research subjects. Almost always, parents must give legal consent for their child to ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. ...

  10. Clinical Trials

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... patients to find out whether a new approach causes any harm. In later phases of clinical trials, ...

  11. Clinical Trials

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    Full Text Available ... issues arise. Participation and Eligibility Each clinical trial defines who is eligible to take part in the ... and Usage No FEAR Act Grants and Funding Customer Service/Center for Health Information Email Alerts Jobs ...

  12. Clinical Trials

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    Full Text Available ... Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit ... public health. We offer a variety of funding mechanisms tailored to planning and conducting clinical trials at ...

  13. Clinical Trials

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    Full Text Available ... at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ... how you feel. Some people will need to travel or stay in hospitals to take part in ...

  14. Clinical Trials

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    Full Text Available ... patients to find out whether a new approach causes any harm. In later phases of clinical trials, ... device improves patient outcomes; offers no benefit; or causes unexpected harm All of these results are important ...

  15. Clinical Trials

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    Full Text Available ... and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, ...

  16. Clinical Trials

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    Full Text Available ... Masking, or "blinding," helps avoid bias. For this reason, researchers also may not be told which treatments ... from a study at any time, for any reason. Also, during the trial, you have the right ...

  17. Clinical Trials

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ...

  18. Clinical Trials

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    Full Text Available ... you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking ... people will need to travel or stay in hospitals to take part in clinical trials. For example, ...

  19. Clinical Trials

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    Full Text Available ... Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and ... drugs, and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical ...

  20. Clinical Trials

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    Full Text Available ... rights that help protect them. Scientific Oversight Institutional Review Board Institutional review boards (IRBs) help provide scientific ... ClinicalTrials.gov View a database of clinical studies (past and present) funded or sponsored by the NIH ...

  1. Clinical Trials

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    Full Text Available ... and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical Studies ... medical centers, and hospitals. ClinicalTrials.gov View a database of clinical studies (past and present) funded or ...

  2. Clinical Trials

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    Full Text Available ... A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...

  3. Clinical Trials

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... always, parents must give legal consent for their child to take part in a clinical trial. When ...

  4. Clinical Trials

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    Full Text Available ... results. Clinical trials are one of the final stages of a long and careful research process. The ... a patient's age and gender, the type and stage of disease, and whether the patient has had ...

  5. Clinical Trials

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    Full Text Available ... medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these ... trials are a key research tool for advancing medical knowledge and patient care. ...

  6. Clinical Trials

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    Full Text Available ... questions to ask your doctor and the research staff, go to "How Do Clinical Trials Protect Participants?" ... in Bethesda, Maryland. The physicians, nurses, scientists and staff of the NHLBI encourage you to explore NIH ...

  7. Clinical Trials

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    Full Text Available ... look at the best age and frequency for doing screening tests, such as mammography; and compare two ... available treatments. Steps To Avoid Bias The researchers doing clinical trials take steps to avoid bias. "Bias" ...

  8. Clinical Trials

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    Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are ...

  9. Clinical Trials

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    Full Text Available ... and how often they will get them; what type of data will be collected during the clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical ...

  10. Clinical Trials

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    Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... IRBs, develop educational programs and materials, and offer advice on research-related issues. Data Safety Monitoring Board ...

  11. Clinical Trials

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    Full Text Available ... has had certain treatments or has other health problems. Eligibility criteria ensure that new approaches are tested ... review data from a clinical trial for safety problems or differences in results among different groups. The ...

  12. Clinical Trials

    Medline Plus

    Full Text Available ... research process. The process often begins in a laboratory (lab), where scientists first develop and test new ... healthy people to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants ...

  13. Clinical Trials

    Medline Plus

    Full Text Available ... or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that ...

  14. Clinical Trials

    Medline Plus

    Full Text Available ... studies. View funding information for clinical trials optimization . Building 31 31 Center Drive Bethesda, MD 20892 Learn ... and Usage No FEAR Act Grants and Funding Building 31 31 Center Drive Bethesda, MD 20892 Learn ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... of research. Sometimes, when no accepted standard treatment exists for a condition, people in one group may ... medical centers, and hospitals. ClinicalTrials.gov View a database of clinical studies (past and present) funded or ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... risk of heart disease in the first few years, and HT also increased the risk of stroke ... the shortest time possible. Clinical trials, like the two described above, help improve and advance medical care. ...

  17. 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 ...

  18. Stem cell trials for cardiovascular medicine: ethical rationale.

    Science.gov (United States)

    Niemansburg, Sophie L; Teraa, Martin; Hesam, Husna; van Delden, Johannes J M; Verhaar, Marianne C; Bredenoord, Annelien L

    2014-10-01

    Stem cell-based interventions provide new treatment prospects for many disease conditions, including cardiovascular disorders. Clinical trials are necessary to collect adequate evidence on (long-term) safety and efficacy of novel interventions such as stem cells, but the design and launch of clinical trials, from first-in-human studies to larger randomized controlled trials (RCTs), is scientifically and ethically challenging. Stem cells are different from traditional pharmaceuticals, surgical procedures, and medical devices in the following ways: the novelty and complexity of stem cells, the invasiveness of the procedures, and the novel aim of regeneration. These specifics, combined with the characteristics of the study population, will have an impact on the design and ethics of RCTs. The recently closed JUVENTAS trial will serve as an example to identify the (interwoven) scientific and ethical challenges in the design and launch of stem cell RCTs. The JUVENTAS trial has investigated the efficacy of autologous bone marrow cells in end-stage vascular patients, in a double-blind sham-controlled design. We first describe the choices, considerations, and experiences of the JUVENTAS team. Subsequently, we identify the main ethical and scientific challenges and discuss what is important to consider in the design of future stem cell RCTs: assessment of risks and benefits, the choice for outcome measures, the choice for the comparator, the appropriate selection of participants, and adequate informed consent. Additionally, the stem cell field is highly in the spotlight due to the (commercial) interests and expectations. This warrants a cautious pace of translation and scrupulous set up of clinical trials, as failures could put the field in a negative light. At the same time, knowledge from clinical trials is necessary for the field to progress. We conclude that in the scientifically and ethically challenging field of stem cell RCTs, researchers and clinicians have to

  19. Closed Loop Fluid Delivery System

    Science.gov (United States)

    2014-02-28

    loop fluid delivery system (CLFDS) will integrate a vital signs monitor ( VSM ) and high speed infusion pump (Pump) to respond quickly to drops in...Interface (GUI) shows VSM data, allows the user to select from several injury types (head, uncontrolled hemorrhage, controlled hemorrhage, and three total...the bedrock for future Closed Loop Fluid System Pre-Market Approval application(s) to FDA. 6. Major Issues Clinical study testing revealed a

  20. Installment options close to expiry

    Directory of Open Access Journals (Sweden)

    G. Alobaidi

    2006-01-01

    Full Text Available We use an asymptotic expansion to study the behavior of installment options close to expiry. Installment options are contracts where the price is paid over the life of the option rather than as a lump sum at the time of purchase, and where the contract can be allowed to lapse at any time. Series solutions are obtained for the location of the free boundary and the price of the option.

  1. Esthetic judgments of palatally displaced canines 3 months postdebond after surgical exposure with either a closed or an open technique.

    Science.gov (United States)

    Parkin, Nicola A; Freeman, Jennifer V; Deery, Chris; Benson, Philip E

    2015-02-01

    The aim of this study was to compare the esthetic judgments of orthodontists and laypeople regarding the appearance of palatally displaced canines 3 months after treatment with either a closed or an open surgical exposure and orthodontic alignment. A multicenter randomized controlled trial was undertaken in 3 hospitals in the United Kingdom. Patients with unilateral palatally displaced canines were randomly allocated to receive either a closed or an open surgical exposure. The teeth were aligned with fixed appliances, and 3 months after debond, intraoral photographs were taken. The photographs were projected in random order to 2 panels of judges (orthodontists and laypeople), who completed a questionnaire. The images of 67 participants (closed, 33; open, 34) were included. The laypeople were able to identify the operated tooth only 49.7% of the time (95% CI, 45.3%-54.0%); this was no better than chance (P = 0.880). The orthodontists were more successful but still identified the treated canine with certainty only 60.7% of the time (95% CI, 53.7%-67.8%; P = 0.003). Both panels more frequently assessed the unoperated canine to have a better appearance than the contralateral operated canine; however, there were no differences between the closed and open groups (proportion preferring unoperated canine-laypeople: closed, 58.7%; open, 57.0%; P = 0.43; and orthodontists: closed, 60.9%; open, 60.6%; P = 0.27). There is an esthetic impact to aligning a palatally displaced canine, but it is mostly minor and unlikely to be detectable by laypeople. The esthetic impact was the same, whether the canine was exposed with a closed or an open surgical technique. Copyright © 2015 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

  2. Closed orbit analysis for RHIC

    International Nuclear Information System (INIS)

    Milutinovic, J.; Ruggiero, A.G.

    1989-01-01

    We examine the effects of four types of errors in the RHIC dipoles and quadrupoles on the on-momentum closed orbit in the machine. We use PATRIS both to handle statistically the effects of kick-modeled errors and to check the performance of the Fermilab correcting scheme in a framework of a more realistic modeling. On the basis of the accepted rms values of the lattice errors, we conclude that in about 40% of all studied cases the lattice must be to some extent pre-corrected in the framework of the so-called ''first turn around strategy,'' in order to get a closed orbit within the aperture limitations at all and, furthermore, for approximately 2/3 of the remaining cases we find that a single pass algorithm of the Fermilab scheme is not sufficient to bring closed orbit distortions down to acceptable levels. We have modified the scheme and have allowed repeated applications of the otherwise unchanged three bump method and in doing so we have been able to correct the orbit in a satisfactory manner. 4 refs., 2 figs., 3 tabs

  3. Basal cell nevus syndrome - close-up of palm (image)

    Science.gov (United States)

    ... skeletal abnormalities. Skin manifestations include pits in the palms and soles, and numerous basal cell carcinomas. This ... close-up of the pits found in the palm of an individual with basal cell nevus syndrome.

  4. Industry-corrupted psychiatric trials.

    Science.gov (United States)

    Amsterdam, Jay D; McHenry, Leemon B; Jureidini, Jon N

    2017-12-30

    The goal of this paper is to expose the research misconduct of pharmaceutical industry sponsored clinical trials via three short case studies of corrupted psychiatric trials that were conducted in the United States. We discuss the common elements that enable the misrepresentation of clinical trial results including ghostwriting for medical journals, the role of key opinion leaders as co-conspirators with the pharmaceutical industry and the complicity of top medical journals in failing to uphold standards of science and peer review. We conclude that the corruption of industry-sponsored clinical trials is one of the major obstacles facing evidence-based medicine.

  5. Defendants' Rights in Criminal Trials.

    Science.gov (United States)

    Martin, Ralph C., II; Keeley, Elizabeth

    1997-01-01

    Reviews the protections afforded by the Constitution for defendants in criminal trials. These include the right to a jury trial (in cases of possible incarceration), an impartial jury, and the requirement of a unanimous verdict. Defends the use of plea bargaining as essential to an efficient criminal justice system. (MJP)

  6. Exploratory analyses of efficacy data from schizophrenia trials in support of new drug applications submitted to the US Food and Drug Administration.

    Science.gov (United States)

    Khin, Ni A; Chen, Yeh-Fong; Yang, Yang; Yang, Peiling; Laughren, Thomas P

    2012-06-01

    There has been concern about a high rate of placebo response and a decline in treatment effect over time in schizophrenia trials as well as the implications of increasing conduct of such trials outside North America. This report explores differences in efficacy data over an 18-year period from randomized placebo-controlled trials submitted in support of new drug applications (NDAs) for the treatment of schizophrenia and differences in results between trials conducted in North America and elsewhere. Clinical trial data that were submitted to the US Food and Drug Administration (FDA) as part of NDAs for the indication of schizophrenia between 1991 and 2009. Efficacy data were compiled from 32 clinical trials with 11,567 evaluable patients with schizophrenia. Data from completed, randomized, multicenter, double-blind, placebo-controlled, 4- to 8-week clinical trials in adult patients diagnosed with schizophrenia according to DSM-III or DSM-IV criteria were included. Baseline demographic and disease characteristics, including mean Positive and Negative Syndrome Scale (PANSS) total scores, were summarized and compared between North American and multiregional trials. Mean change from baseline to endpoint in PANSS total scores was utilized as the primary outcome of interest. We explored differences in treatment effect and success rate of these trials based on when and where the studies were conducted, sample size, trial duration, and baseline patient characteristics. Twenty-one of the 32 trials were conducted solely in North America, and 11 were carried out in multiple regions. Of those 11 multiregional trials, 2 were conducted exclusively in foreign countries. Although the observed responses (change from baseline) in placebo and drug-treated groups in multiregional trials tended to be larger than in North American trials, the treatment effects (drug-placebo difference) were -9 and -8 PANSS units for North American and multiregional trials, respectively. When time of

  7. Cascaded recompression closed brayton cycle system

    Energy Technology Data Exchange (ETDEWEB)

    Pasch, James J.

    2018-01-02

    The present disclosure is directed to a cascaded recompression closed Brayton cycle (CRCBC) system and method of operation thereof, where the CRCBC system includes a compressor for compressing the system fluid, a separator for generating fluid feed streams for each of the system's turbines, and separate segments of a heater that heat the fluid feed streams to different feed temperatures for the system's turbines. Fluid exiting each turbine is used to preheat the fluid to the turbine. In an embodiment, the amount of heat extracted is determined by operational costs.

  8. AA, closed orbit observation pickup

    CERN Multimedia

    CERN PhotoLab

    1980-01-01

    Electrostatic pickups around the circumference of the AA served for the measurement of the closed orbits across the wide momentum range of +- 3% to either side of central orbit. The pickups were of the "shoebox" type, with diagonal cuts, a horizontal and a vertical one mechanically coupled together. They were located where they would not require extra space. The wide ones (very wide indeed: 70 cm), like the one we see here, were placed inside the vacuum chamber of the wide quadrupoles QFW, at maximum dispersion. See also 8001372, 8001383, 8010045

  9. AA, closed orbit observation pickup

    CERN Multimedia

    CERN PhotoLab

    1980-01-01

    Electrostatic pickups around the circumference of the AA served for the measurement of the closed orbits across the wide momentum range of +- 3% to either side of central orbit. The pickups were of the "shoebox" type, with diagonal cuts, a horizontal and a vertical one mechanically coupled together. They were located where they would not require extra space. The wide ones (very wide indeed: 70 cm), like the one we see here, were placed inside the vacuum chamber of the wide quadrupoles, QFW, at maximum dispersion. See also 8001372,8001383, 8010042

  10. AA, closed orbit observation pickup

    CERN Multimedia

    1980-01-01

    Electrostatic pickups around the circumference of the AA served for the measurement of the closed orbits across the wide momentum range of +- 3% to either side of central orbit. The pickups were of the "shoebox" type, with diagonal cuts, a horizontal and a vertical one mechanically coupled together. They were located where they would not require extra space. The small ones, like the one we see here, were inserted into the vacuum chamber of the BLG (long and narrow) bending magnets. See also 8001372, 8010042, 8010045

  11. AA, closed orbit observation pickup

    CERN Multimedia

    CERN PhotoLab

    1980-01-01

    Electrostatic pickups around the circumference of the AA served for the measurement of the closed orbits across the wide momentum range of +- 3% to either side of central orbit. The pickups were of the "shoebox" type, with diagonal cuts, a horizontal and a vertical one mechanically coupled together. They were located where they would not require extra space. The small ones, like the one we see here, were inserted into the vacuum chamber of the BLG (long and narrow) bending magnets. Werner Sax contemplates his achievement. See also 8001383, 8010042, 8010045.

  12. A Closed Universe Expanding Forever

    Directory of Open Access Journals (Sweden)

    Silva N. P.

    2014-07-01

    Full Text Available In a recent paper, the expression a ( t = e H 0 T 0 [ ( t T 0 where = 0 : 5804, was proposed for the expansion factor of our Universe. According to it, gravity dominates the expan- sion ( matter era until the age of T ⋆ = 3 : 214 Gyr and, after that, dark energy dominates ( dark energy era leading to an eternal expansion, no matter if the Universe is closed, flat or open. In this paper we consider only the closed version and show that there is an upper limit for the size of the radial comoving coordinate, beyond which nothing is observed by our fundamental observer, on Earth. Our observable Universe may be only a tiny portion of a much bigger Universe most of it unobservable to us. This leads to the idea that an endless number of other fundamental observers may live on equal number of Universes similar to ours. Either we talk about many Universes — Multiverse — or about an unique Universe, only part of it observable to us.

  13. Generalized closed sets: a unified approach

    Directory of Open Access Journals (Sweden)

    Jiling Cao

    2001-10-01

    Full Text Available We investigate various classes of generalized closed sets of a topological space in a unified way by studying the notion of qr-closed sets. New characterizations of some existing classes of generalized closed sets and topological spaces are given. A new class of generalized closed sets are introduced.

  14. On some properties of conjugacy closed loops

    International Nuclear Information System (INIS)

    Adeniran, John Olusola

    2002-07-01

    It is shown that central loops are not conjugacy closed loops but instead are loops of units in their loop algebras that are conjugacy closed. It is also shown that certain inner mappings of a conjugacy closed loop are nuclear. Some invariants of left conjugacy closed loops are obtained. (author)

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

    Directory of Open Access Journals (Sweden)

    Bisits Andrew

    2011-09-01

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

  16. The CYTONOX trial

    DEFF Research Database (Denmark)

    Gade, Christina; Mikus, Gerd; Christensen, Hanne Rolighed

    2016-01-01

    INTRODUCTION: In Denmark, it is estimated that 3-5% of children are obese. Obesity is associated with pathophysiological alterations that may lead to alterations in the pharmacokinetics of drugs. In adults, obesity was found to influence important drug-metabolising enzyme pathways. The impact...... of obesity-related alterations on drug metabolism and its consequences for drug dosing remains largely unknown in both children and adults. An altered drug metabolism may contribute significantly to therapeutic failure or toxicity. The aim of this trial is to investigate the in vivo activity of CYP3A4, CYP2E......1 and CYP1A2 substrates in obese versus non-obese children. METHODS: The CYTONOX trial is an open-label explorative pharmacokinetic trial. We intend to include 50 obese and 50 non-obese children. The primary end points are: in vivo clearance of CYP3A4, CYP2E1 and CYP1A2 substrates, which...

  17. 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...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ... Studies Women’s Health All Science A-Z Grants & Training Grants and Training Home Policies and Guidelines Funding ...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... clinical trials that have not only shaped medical practice around the world, but have improved the health of millions of people suffering from heart, lung, and blood disorders. By engaging the research community and a broad group of stakeholders and advisory ...

  20. Clinical Trials

    Medline Plus

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

  1. Clinical Trials

    Medline Plus

    Full Text Available ... moderate persistent asthma. The results provided important treatment information for doctors and patients. The results from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... treatments produce better results for certain illnesses or groups of people; look at the best age and frequency for doing screening tests, such as mammography; and compare two or more screening tests to see which test ... Some companies and groups sponsor clinical trials that test the safety of ...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain access to new treatments before they're widely available. If a new treatment is proven to work and you're in the group getting it, ...

  4. Clinical Trials

    Medline Plus

    Full Text Available ... safe a treatment is or how well it works. Children (aged 18 and younger) get special protection as research subjects. Almost always, parents must give legal consent for their child to take part in a clinical trial. When ...

  5. Clinical Trials

    Medline Plus

    Full Text Available ... educational programs and materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board ... of a group of research and study topic experts. The NIH also requires ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ... Activity Population and Epidemiology Studies Women’s Health All Science A-Z Grants & Training Grants and Training Home Policies and Guidelines Funding ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... people and is safe and which treatments or strategies work best for certain illnesses or groups of people. Some clinical trials show a positive ... available. If a new treatment is proven to work and you're in the group getting ... get the new strategy being tested, you may receive the current standard ...

  8. Clinical Trials

    Medline Plus

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

  9. Clinical Trials

    Medline Plus

    Full Text Available ... patients. The results from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI ... had to accept medicines and treatments based on what is known to work in adults. To improve clinical care of children, ...

  10. Clinical Trials

    Medline Plus

    Full Text Available ... Wide Range of Audiences The Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, ...

  11. Clinical Trials

    Medline Plus

    Full Text Available ... In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews applications for new medicines and devices before any testing on humans is done. They check to make sure that ...

  12. Effect of two recovery methods on repeated closed-handed and open-handed weight-assisted pull-ups.

    Science.gov (United States)

    Bacon, Nicholas T; Wingo, Jonathan E; Richardson, Mark T; Ryan, Greg A; Pangallo, Tracey C; Bishop, Phillip A

    2012-05-01

    The purpose of this study was to examine 2 recovery modalities (with and without an ice bag treatment) on closed-handed and open-handed weight-assisted pull-ups in recreationally-trained rock climbers. Healthy and recreationally active volunteers (n = 9) completed 4 counterbalanced trials separated by 72 hours. Trials included 3 sets of closed-handed and open-handed weight-assisted pull-ups supported by 50% of body weight, until failure. Between each set, participants sat quietly in a chair and engaged in approximately 20 minutes of either passive or ice bag treatment. Ice bags were placed on the participants' arms and shoulders. Heart rate (HR), ratings of perceived exertion (RPE), session-RPE (S-RPE), and perceived recovery were also assessed. Hand-grip strength pretrial and posttrial was not different between ice bag conditions. Also, there were no differences between treatments for HR, RPE, perceived recovery, S-RPE, or comfort ratings. The overall number of open-handed pull-ups (mean ± SD = 19 ± 5) was lower than closed-handed pull-ups (34 ± 14; p up performance for sets 2 (22 ± 5; p = 0.004) and 3 (22 ± 5; p = 0.003) relative to set 3 using passive recovery only (i.e., no ice bag; 17 ± 6). There were no differences (p = 0.31) between treatments for closed-handed pull-ups. The findings support the recommendations to use ice bags for recovery between bouts of rock climbing that involve a predominantly open-handed grip to maintain performance.

  13. Closing the Cybersecurity Skills Gap

    Directory of Open Access Journals (Sweden)

    Rebecca Vogel

    2016-05-01

    Full Text Available The current consensus is that there is a worldwide gap in skills needed for a competent cybersecurity workforce. This skills gap has implications for the national security sector, both public and private. Although the view is that this will take a concerted effort to rectify, it presents an opportunity for IT professionals, university students, and aspirants to take-up jobs in national security national intelligence as well military and law enforcement intelligence. This paper examines context of the issue, the nature of the cybersecurity skills gap, and some key responses by governments to address the problem. The paper also examines the emerging employment trends, some of the employment challenges, and what these might mean for practice. The paper argues that the imperative is to close the cyber skills gap by taking advantage of the window of opportunity, allowing individuals interested in moving into the cybersecurity field to do so via education and training.

  14. Textbook of clinical trials

    National Research Council Canada - National Science Library

    Day, Simon; Machin, David; Green, Sylvan B

    2006-01-01

    ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 The Development of Clinical Trials Simon...

  15. Internet interventions for chronic pain including headache: A systematic review

    Directory of Open Access Journals (Sweden)

    Monica Buhrman

    2016-05-01

    Full Text Available Chronic pain is a major health problem and behavioral based treatments have been shown to be effective. However, the availability of these kinds of treatments is scarce and internet-based treatments have been shown to be promising in this area. The objective of the present systematic review is to evaluate internet-based interventions for persons with chronic pain. The specific aims are to do an updated review with a broad inclusion of different chronic pain diagnoses and to assess disability and pain and also measures of catastrophizing, depression and anxiety. A systematic search identified 891 studies and 22 trials were selected as eligible for review. Two of the selected trials included children/youth and five included individuals with chronic headache and/or migraine. The most frequently measured domain reflected in the primary outcomes was interference/disability, followed by catastrophizing. Result across the studies showed a number of beneficial effects. Twelve trials reported significant effects on disability/interference outcomes and pain intensity. Positive effects were also found on psychological variable such as catastrophizing, depression and anxiety. Several studies (n = 12 were assessed to have an unclear level of risk bias. The attrition levels ranged from 4% to 54% where the headache trials had the highest drop-out levels. However, findings suggest that internet-based treatments based on cognitive behavioural therapy (CBT are efficacious measured with different outcome variables. Results are in line with trials in clinical settings. Meta-analytic statistics were calculated for interference/disability, pain intensity, catastrophizing and mood ratings. Results showed that the effect size for interference/disability was Hedge's g = −0.39, for pain intensity Hedge's g = −0.33, for catastrophizing Hedge's g = −0.49 and for mood variables (depression Hedge's g = −0.26.

  16. Dem Generation from Close-Range Photogrammetry Using Extended Python Photogrammetry Toolbox

    Science.gov (United States)

    Belmonte, A. A.; Biong, M. M. P.; Macatulad, E. G.

    2017-10-01

    Digital elevation models (DEMs) are widely used raster data for different applications concerning terrain, such as for flood modelling, viewshed analysis, mining, land development, engineering design projects, to name a few. DEMs can be obtained through various methods, including topographic survey, LiDAR or photogrammetry, and internet sources. Terrestrial close-range photogrammetry is one of the alternative methods to produce DEMs through the processing of images using photogrammetry software. There are already powerful photogrammetry software that are commercially-available and can produce high-accuracy DEMs. However, this entails corresponding cost. Although, some of these software have free or demo trials, these trials have limits in their usable features and usage time. One alternative is the use of free and open-source software (FOSS), such as the Python Photogrammetry Toolbox (PPT), which provides an interface for performing photogrammetric processes implemented through python script. For relatively small areas such as in mining or construction excavation, a relatively inexpensive, fast and accurate method would be advantageous. In this study, PPT was used to generate 3D point cloud data from images of an open pit excavation. The PPT was extended to add an algorithm converting the generated point cloud data into a usable DEM.

  17. Practical trials in medical education

    DEFF Research Database (Denmark)

    Tolsgaard, Martin G; Kulasegaram, Kulamakan M; Ringsted, Charlotte

    2017-01-01

    controlled settings generalise to the real-life education context. One way of bridging this gap is applying the concept of practical trials in medical education. In this paper we elaborate on characteristics of practical trials and based on examples from medical education we discuss the challenges......-inferiority or equivalence designs are recommended when comparing viable alternatives and the use of crossover designs, cluster randomisation or stepped wedge trial designs are feasible when studying implementations across several settings. Outcome measures may include variables related to learners, teachers, educational...... administration, quality of care, patient outcomes and cost. CONCLUSIONS: Practical trials in medical education may contribute to bridge the gap between education theory and practice and aid decision makers in making evidence-based choices and priorities. Conducting practical trials is not without challenges...

  18. How close can you go?

    DEFF Research Database (Denmark)

    Skrubbeltrang, Lotte Stausgaard; Rasmussen, Annette

    In ethnographic research the direct involvement and long-term engagement of the researcher constitute key elements. Acknowledgements of numerous publications resulting from ethnographic studies illustrate that the researchers are often deeply indebted to the research subjects for allowing the res......, and to ensure that the subjects under scrutiny are not subject to ethical violations. With this in mind the above dilemmas of proximity will be addressed and discussed in our paper....... having gained access to participate in and describe the lives of the participants of a given context, the next ethical question facing the researcher is the one of involvement. Again, the researcher has an interest in obtaining as much confidence as possible, whereas the interest of the observed subjects...... might be more dubious and a matter of difficulty to handle by the researcher. The obvious dilemma of conflicting interests and difficult handling of proximity is our focus of interest in this paper: One side of this dilemma is to ask the question, how close you need to go to obtain the confidence...

  19. Open and Closed Biographical Politicization

    Directory of Open Access Journals (Sweden)

    Dirk Michel-Schertges

    2011-05-01

    Full Text Available The article deals with political socialization with particular consideration of open and closed processes of biographical politicization, i.e. biographical alienation. Based on narrative-biographical and theme-oriented interviews with two survivors of the Holocaust, processes of consciousness are analyzed. Henri LEFEBVRE refers in the chapter "the lived and the living" in his third volume of the "Critique of Everyday Live" (1975 to the complexity of processes of consciousness. According to LEFEBVRE there is a dialectic between the "lived" and the "living", thus the "lived" cannot be characterized only as past actions but as past experiences, constituting dialectically the present—the "living." For LEFEBVRE there is an inescapable conflict between past experiences and present life, i.e. the past could be seen as a constituting part of the conditions of individual (and societal present consciousness. Following this line of thought, one could state that to analyze former biographical (extraordinary experiences, i.e. "the lived," is crucial to better understanding of the constitutional conditions of processes of political socialization. Thus former extraordinary biographical experiences might have an essential impact on political socialization and, therefore, on political attitudes. URN: http://nbn-resolving.de/urn:nbn:de:0114-fqs1102225

  20. Childhood close family relationships and health.

    Science.gov (United States)

    Chen, Edith; Brody, Gene H; Miller, Gregory E

    2017-09-01

    Emerging data suggest that during childhood, close family relationships can ameliorate the impact that adversity has on life span physical health. To explain this phenomenon, a developmental stress buffering model is proposed in which characteristics of family relationships including support, conflict, obligation, and parenting behaviors evolve and change from childhood to adolescence. Together, these characteristics govern whether childhood family relationships are on balance positive enough to fill a moderating role in which they mitigate the effects that childhood adversities have on physical health. The benefits of some family relationship characteristics are hypothesized to stay the same across childhood and adolescence (e.g., the importance of comfort and warmth from family relationships) whereas the benefits of other characteristics are hypothesized to change from childhood to adolescence (e.g., from a need for physical proximity to parents in early childhood to a need for parental availability in adolescence). In turn, close, positive family relationships in childhood operate via a variety of pathways, such as by reducing the impact that childhood stressors have on biological processes (e.g., inflammation) and on health behaviors that in turn can shape physical health over a lifetime. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  1. Closed cycle refrigeration for routine magnetotransport measurements

    Science.gov (United States)

    Gunawardana, Binuka; Ye, Tianyu; Wegscheider, Werner; Mani, Ramesh

    2015-03-01

    Condensed matter physics is often interested in the behavior of materials at very low temperatures. Low temperatures have traditionally been realized using liquid helium. However, the recent scarcity of liquid helium and the rapid rise in its cost has encouraged the development of alternative approaches, based on closed cycle refrigerators, for realizing low temperatures. Here, we convey our experiences in developing a home-made, low cost, variable temperature closed cycle refrigeration system for routine magnetotransport measurements down to 10K, and present measurements obtained with this system relating to the electronic properties of the high mobility GaAs/AlGaAs 2D semiconductors system. The setup was constructed to examine 0.5cm × 0.5cm semiconductor chips including up to 49 leads and reach ~ 10K within 3 hours. A computer controlled data acquisition system was assembled to collect resistivity and Hall effect data, and extract the carrier Hall mobility and density as a function of the temperature.

  2. Close Range Sonar System and Method

    National Research Council Canada - National Science Library

    Carter, G. C

    2004-01-01

    A system for close range sonar is provided. The system provides sufficient warning to permit maneuvering to avoid a close encounter even in the forward starboard/port regions, which have been problematic in the past due to ownship noise...

  3. 76 FR 76451 - Post Office Closing

    Science.gov (United States)

    2011-12-07

    ... the closing of the Nixon, Nevada post office has been filed. It identifies preliminary steps and... Postal Service's determination to close the Nixon post office in Nixon, Nevada. The petition for review...

  4. 27 CFR 70.485 - Closing agreements.

    Science.gov (United States)

    2010-04-01

    ... Relating to Alcohol, Tobacco, Firearms, and Explosives Administrative Remedies § 70.485 Closing agreements... disadvantage through consummation of such an agreement. (b) Scope of closing agreement—(1) In general. A...

  5. Current status and perspectives of interventional clinical trials for glioblastoma - analysis of ClinicalTrials.gov.

    Science.gov (United States)

    Cihoric, Nikola; Tsikkinis, Alexandros; Minniti, Giuseppe; Lagerwaard, Frank J; Herrlinger, Ulrich; Mathier, Etienne; Soldatovic, Ivan; Jeremic, Branislav; Ghadjar, Pirus; Elicin, Olgun; Lössl, Kristina; Aebersold, Daniel M; Belka, Claus; Herrmann, Evelyn; Niyazi, Maximilian

    2017-01-03

    The records of 208.777 (100%) clinical trials registered at ClinicalTrials.gov were downloaded on the 19th of February 2016. Phase II and III trials including patients with glioblastoma were selected for further classification and analysis. Based on the disease settings, trials were classified into three groups: newly diagnosed glioblastoma, recurrent disease and trials with no differentiation according to disease setting. Furthermore, we categorized trials according to the experimental interventions, the primary sponsor, the source of financial support and trial design elements. Trends were evaluated using the autoregressive integrated moving average model. Two hundred sixteen (0.1%) trials were selected for further analysis. Academic centers (investigator initiated trials) were recorded as primary sponsors in 56.9% of trials, followed by industry 25.9%. Industry was the leading source of monetary support for the selected trials in 44.4%, followed by 25% of trials with primarily academic financial support. The number of newly initiated trials between 2005 and 2015 shows a positive trend, mainly through an increase in phase II trials, whereas phase III trials show a negative trend. The vast majority of trials evaluate forms of different systemic treatments (91.2%). In total, one hundred different molecular entities or biologicals were identified. Of those, 60% were involving drugs specifically designed for central nervous system malignancies. Trials that specifically address radiotherapy, surgery, imaging and other therapeutic or diagnostic methods appear to be rare. Current research in glioblastoma is mainly driven or sponsored by industry, academic medical oncologists and neuro-oncologists, with the majority of trials evaluating forms of systemic therapies. Few trials reach phase III. Imaging, radiation therapy and surgical procedures are underrepresented in current trials portfolios. Optimization in research portfolio for glioblastoma is needed.

  6. Expectations and Attitudes of Individuals With Type 1 Diabetes After Using a Hybrid Closed Loop System.

    Science.gov (United States)

    Iturralde, Esti; Tanenbaum, Molly L; Hanes, Sarah J; Suttiratana, Sakinah C; Ambrosino, Jodie M; Ly, Trang T; Maahs, David M; Naranjo, Diana; Walders-Abramson, Natalie; Weinzimer, Stuart A; Buckingham, Bruce A; Hood, Korey K

    2017-04-01

    Purpose The first hybrid closed loop (HCL) system, which automates insulin delivery but requires user inputs, was approved for treatment of type 1 diabetes (T1D) by the US Food and Drug Administration in September 2016. The purpose of this study was to explore the benefits, expectations, and attitudes of individuals with T1D following a clinical trial of an HCL system. Methods Thirty-two individuals with T1D (17 adults, 15 adolescents) participated in focus groups after 4 to 5 days of system use. Content analysis generated themes regarding perceived benefits, hassles, and limitations. Results Some participants felt misled by terms such as "closed loop" and "artificial pancreas," which seemed to imply a more "hands-off" experience. Perceived benefits were improved glycemic control, anticipated reduction of long-term complications, better quality of life, and reduced mental burden of diabetes. Hassles and limitations included unexpected tasks for the user, difficulties wearing the system, concerns about controlling highs, and being reminded of diabetes. Conclusion Users are willing to accept some hassles and limitations if they also perceive health and quality-of-life benefits beyond current self-management. It is important for clinicians to provide a balanced view of positives and negatives to help manage expectations.

  7. Successful recruitment to trials: findings from the SCIMITAR+ Trial.

    Science.gov (United States)

    Peckham, Emily; Arundel, Catherine; Bailey, Della; Callen, Tracy; Cusack, Christina; Crosland, Suzanne; Foster, Penny; Herlihy, Hannah; Hope, James; Ker, Suzy; McCloud, Tayla; Romain-Hooper, Crystal-Bella; Stribling, Alison; Phiri, Peter; Tait, Ellen; Gilbody, Simon

    2018-01-19

    Randomised controlled trials (RCT) can struggle to recruit to target on time. This is especially the case with hard to reach populations such as those with severe mental ill health. The SCIMITAR+ trial, a trial of a bespoke smoking cessation intervention for people with severe mental ill health achieved their recruitment ahead of time and target. This article reports strategies that helped us to achieve this with the aim of aiding others recruiting from similar populations. SCIMITAR+ is a multi-centre pragmatic two-arm parallel-group RCT, which aimed to recruit 400 participants with severe mental ill health who smoke and would like to cut down or quit. The study recruited primarily in secondary care through community mental health teams and psychiatrists with a smaller number of participants recruited through primary care. Recruitment opened in October 2015 and closed in December 2016, by which point 526 participants had been recruited. We gathered information from recruiting sites on strategies which led to the successful recruitment in SCIMITAR+ and in this article present our approach to trial management along with the strategies employed by the recruiting sites. Alongside having a dedicated trial manager and trial management team, we identified three main themes that led to successful recruitment. These were: clinicians with a positive attitude to research; researchers and clinicians working together; and the use of NHS targets. The overriding theme was the importance of relationships between both the researchers and the recruiting clinicians and the recruiting clinicians and the participants. This study makes a significant contribution to the limited evidence base of real-world cases of successful recruitment to RCTs and offers practical guidance to those planning and conducting trials. Building positive relationships between clinicians, researchers and participants is crucial to successful recruitment.

  8. Microprobe to closely examine minerals

    International Nuclear Information System (INIS)

    2006-01-01

    The University of South Australia will develop synchrotron-based technology that can determine the structure and chemical composition of mineral samples at microscopic levels. The planned multi-analysis synchrotron X-ray facility Beam-line 11 is for implementing on the Australian Synchrotron. UniSA's Applied Centre for Structural and Synchrotron Studies (ACeSSS) will use Beamline 11 to shed new light on factors that constrain recoveries of copper and gold from typical copper ores. ACeSSS director Professor Andrea Gerson is working with an international team and the Australian Synchrotron on the design of Beamline 11. According to Gerson, there is scope to improve processing and/or increase recoveries in copper, gold and valueless pyrite either through separation, smelting, leaching or electro-processing. Using synchrotron technology, researchers will determine the structure and chemical composition of mineral samples to understand the fundamental behaviour of these materials in order to identify process and : environmental benefits. Three different strategies will be employed: tracing the movement of gold through the mineral processing chain to optimise and increase gold recovery; examining the surface layers formed when copper is leached from the mineral, chalcopyrite, to enhance the understanding of this surface layer formation and ultimately maximise cop-per recovery; and improving environmental remediation by understanding the mineralisation process during acid-rock drainage. ACeSSS will work with the minerals and environmental remediation sectors, building on the I establishment of the Cooperative Research Centre for Contamination Assessment and Remediation of the Environment, and cementing close collaboration with UniSA's Ian Wark Research Institute. Contributions from the SA Premier's Science and Research Fund, BHP Billiton and Rio Tinto, synchrotron partners Advanced Light Source (USA) and the Canadian Light Source Funding totalling $1.38m are available for

  9. IMPROVE trial: a randomized controlled trial of patient-controlled analgesia for sickle cell painful episodes: rationale, design challenges, initial experience, and recommendations for future studies.

    Science.gov (United States)

    Dampier, Carlton D; Smith, Wally R; Wager, Carrie G; Kim, Hae-Young; Bell, Margaret C; Miller, Scott T; Weiner, Debra L; Minniti, Caterina P; Krishnamurti, Lakshmanan; Ataga, Kenneth I; Eckman, James R; Hsu, Lewis L; McClish, Donna; McKinlay, Sonja M; Molokie, Robert; Osunkwo, Ifeyinwa; Smith-Whitley, Kim; Telen, Marilyn J

    2013-04-01

    The hallmark of sickle cell disease (SCD) is pain from a vaso-occlusive crisis. Although ambulatory pain accounts for most days in pain, pain is also the most common cause of hospitalization and is typically treated with parenteral opioids. The evidence base is lacking for most analgesic practice in SCD, particularly for the optimal opioid dosing for patient-controlled analgesia (PCA), in part because of the challenges of the trial design and conduct for this rare disease. The purpose of this report is to describe our Network's experiences with protocol development, implementation, and analysis, including overall study design, the value of pain assessments rather than 'crisis' resolution as trial endpoints, and alternative statistical analysis strategies. The Improving Pain Management and Outcomes with Various Strategies (IMPROVE) PCA trial was a multisite inpatient randomized controlled trial comparing two PCA-dosing strategies in adults and children with SCD and acute pain conducted by the SCD Clinical Research Network. The specified primary endpoint was a 25-mm change in a daily average pain intensity using a Visual Analogue Scale, and a number of related pain intensity and pain interference measures were selected as secondary efficacy outcomes. A time-to-event analysis strategy was planned for the primary endpoint. Of 1116 individuals admitted for pain at 31 participating sites over a 6-month period, 38 were randomized and 4 withdrawn. The trial was closed early due to poor accrual, reflecting a substantial number of challenges encountered during trial implementation. While some of the design issues were unique to SCD or analgesic studies, many of the trial implementation challenges reflected the increasing complexity of conducting clinical trials in the inpatient setting with multiple care providers and evolving electronic medical record systems, particularly in the context of large urban academic medical centers. Complicated clinical organization of many

  10. Weakly Iπg-Closed Sets

    OpenAIRE

    Ravi, O.

    2015-01-01

    called weakly Iπg-open sets in ideal topological spaces is introduced and the notion of weakly Iπg-closed sets in ideal topologicalspaces is studied. The relationships of weakly Iπg-closed sets andvarious properties of weakly Iπg-closed sets are investigated

  11. ON NANO Λg-CLOSED SETS

    OpenAIRE

    Rajasekaran, Ilangovan; Nethaji, Ochanan

    2017-01-01

    Abstaract−In this paper, we introduce nano ∧g-closed sets in nano topological spaces. Some properties of nano ∧g-closed sets and nano ∧g-open sets are weaker forms of nano closed sets and nano open sets

  12. Closing the Knowledge Gap in Foreign Markets

    DEFF Research Database (Denmark)

    Lyles, Marjorie A.; Pedersen, Torben; Petersen, Bent

    The study explores how firms close their knowledge gaps in relation to business environments of foreign markets. Potential determinants are derived from traditional internationalization process theory as well as more recent literature on organizational learning processes, including the concept...... of absorptive capacity. Building on these two literature streams a conceptual model is developed and tested on a set of primary data of Danish firms and their foreign market operations. The empirical study suggests that factors considered essential in traditional internationalization process theory......, such as experiential learning, explains only a very limited part of perceived knowledge gaps. When factors pertaining to the concepts of absorptive capacity and superstitious learning are added, the explanatory power improves significantly. Apparently, our understanding of firms' internationalization processes can...

  13. Monitoring Digital Closed-Loop Feedback Systems

    Science.gov (United States)

    Katz, Richard; Kleyner, Igor

    2011-01-01

    A technique of monitoring digital closed-loop feedback systems has been conceived. The basic idea is to obtain information on the performances of closed-loop feedback circuits in such systems to aid in the determination of the functionality and integrity of the circuits and of performance margins. The need for this technique arises as follows: Some modern digital systems include feedback circuits that enable other circuits to perform with precision and are tolerant of changes in environment and the device s parameters. For example, in a precision timing circuit, it is desirable to make the circuit insensitive to variability as a result of the manufacture of circuit components and to the effects of temperature, voltage, radiation, and aging. However, such a design can also result in masking the indications of damaged and/or deteriorating components. The present technique incorporates test circuitry and associated engineering-telemetry circuitry into an embedded system to monitor the closed-loop feedback circuits, using spare gates that are often available in field programmable gate arrays (FPGAs). This technique enables a test engineer to determine the amount of performance margin in the system, detect out of family circuit performance, and determine one or more trend(s) in the performance of the system. In one system to which the technique has been applied, an ultra-stable oscillator is used as a reference for internal adjustment of 12 time-to-digital converters (TDCs). The feedback circuit produces a pulse-width-modulated signal that is fed as a control input into an amplifier, which controls the circuit s operating voltage. If the circuit s gates are determined to be operating too slowly or rapidly when their timing is compared with that of the reference signal, then the pulse width increases or decreases, respectively, thereby commanding the amplifier to increase or reduce, respectively, its output level, and "adjust" the speed of the circuits. The nominal

  14. Feedback - closing the loop digitally

    International Nuclear Information System (INIS)

    Zagel, J.; Chase, B.

    1992-01-01

    Many feedback and feedforward systems are now using microprocessors within the loop. We describe the wide range of possibilities and problems that arise. We also propose some ideas for analysis and testing, including examples of motion control in the Flying Wire systems in Main Ring and Tevatron and Low Level RF control now being built for the Fermilab Linac upgrade. (author)

  15. One-year sustained glycaemic control and less hypoglycaemia with new insulin glargine 300 U/ml compared with 100 U/ml in people with type 2 diabetes using basal plus meal-time insulin: the EDITION 1 12-month randomized trial, including 6-month extension.

    Science.gov (United States)

    Riddle, M C; Yki-Järvinen, H; Bolli, G B; Ziemen, M; Muehlen-Bartmer, I; Cissokho, S; Home, P D

    2015-09-01

    To evaluate the maintenance of efficacy and safety of insulin glargine 300 U/ml (Gla-300) versus glargine 100 U/ml (Gla-100) in people with type 2 diabetes mellitus (T2DM) using basal plus meal-time insulin for 12 months in the EDITION 1 trial. EDITION 1 was a multicentre, randomized, open-label, two-arm, phase IIIa study. Participants completing the initial 6-month treatment period continued to receive Gla-300 or Gla-100, as previously randomized, once daily for a further 6-month open-label extension phase. Changes in glycated haemoglobin (HbA1c) and fasting plasma glucose concentrations, insulin dose, hypoglycaemic events and body weight were assessed. Of 807 participants enrolled in the initial phase, 89% (359/404) assigned to Gla-300 and 88% (355/403) assigned to Gla-100 completed 12 months. Glycaemic control was sustained in both groups (mean HbA1c: Gla-300, 7.24%; Gla-100, 7.42%), with more sustained HbA1c reduction for Gla-300 at 12 months: least squares mean difference Gla-300 vs Gla-100: HbA1c -0.17 [95% confidence interval (CI) -0.30 to -0.05]%. The mean daily basal insulin dose at 12 months was 1.03 U/kg for Gla-300 and 0.90 U/kg for Gla-100. Lower percentages of participants had ≥1 confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemic event with Gla-300 than Gla-100 at any time of day [24 h; 86 vs 92%; relative risk 0.94 (95% CI 0.89-0.99)] and during the night [54 vs 65%; relative risk 0.84 (95% CI 0.75-0.94)], while the annualized rates of such hypoglycaemic events were similar. No between-treatment differences in adverse events were apparent. During 12 months of treatment of T2DM requiring basal and meal-time insulin, glycaemic control was better sustained and fewer individuals reported hypoglycaemia with Gla-300 than with Gla-100. The mean basal insulin dose was higher with Gla-300 compared with Gla-100, but total numbers of hypoglycaemic events and overall tolerability did not differ between treatments. © 2015 The Authors. Diabetes

  16. Closed-loop artificial pancreas systems: physiological input to enhance next-generation devices.

    Science.gov (United States)

    Kudva, Yogish C; Carter, Rickey E; Cobelli, Claudio; Basu, Rita; Basu, Ananda

    2014-01-01

    To provide an understanding of both the preclinical and clinical aspects of closed-loop artificial pancreas systems, we provide a discussion of this topic as part of this two-part Bench to Clinic narrative. Here, the Bench narrative provides an in-depth understanding of insulin-glucose-glucagon physiology in conditions that mimic the free-living situation to the extent possible in type 1 diabetes that will help refine and improve future closed-loop system algorithms. In the Clinic narrative, Doyle and colleagues compare and evaluate technology used in current closed-loop studies to gain further momentum toward outpatient trials and eventual approval for widespread use.

  17. Trust in hybrid closed loop among people with diabetes: Perspectives of experienced system users.

    Science.gov (United States)

    Tanenbaum, Molly L; Iturralde, Esti; Hanes, Sarah J; Suttiratana, Sakinah C; Ambrosino, Jodie M; Ly, Trang T; Maahs, David M; Naranjo, Diana; Walders-Abramson, Natalie; Weinzimer, Stuart A; Buckingham, Bruce A; Hood, Korey K

    2017-07-01

    Automated closed loop systems will greatly change type 1 diabetes management; user trust will be essential for acceptance of this new technology. This qualitative study explored trust in 32 individuals following a hybrid closed loop trial. Participants described how context-, system-, and person-level factors influenced their trust in the system. Participants attempted to override the system when they lacked trust, while trusting the system decreased self-management burdens and decreased stress. Findings highlight considerations for fostering trust in closed loop systems. Systems may be able to engage users by offering varying levels of controls to match trust preferences.

  18. TeV-scale jet energy calibration using multijet events including close-by jet effects at the ATLAS experiment

    CERN Document Server

    The ATLAS collaboration

    2013-01-01

    With the large number of proton-proton collisions delivered by the Large Hadron Collider at a centre-of-mass energy of $\\sqrt{s}=7$ TeV in 2011, it became possible to probe the jet transverse momentum (pT) scale beyond the TeV range in events with multijet production. The jet energy scale (JES) uncertainty, which is one of the most important sources of systematic uncertainties for new physics searches at high pT, is evaluated using in-situ techniques based on the pT balance in events with a photon or $Z$ boson as well as in dijet events. Exploiting the pT balance technique between a system of low-pT jets and a leading jet at high pT in multijet events, with the calibration (provided by the gamma-jet and Z+jet events) applied to the low-pT jets, allows the extension of the in-situ determination of JES calibration and uncertainty to the TeV-scale. Results are presented for the JES uncertainty using the multijet balance technique based on the ATLAS data collected in 2011 corresponding to an integrated luminosity...

  19. Strategies to improve retention in randomised trials.

    Science.gov (United States)

    Brueton, Valerie C; Tierney, Jayne; Stenning, Sally; Harding, Seeromanie; Meredith, Sarah; Nazareth, Irwin; Rait, Greta

    2013-12-03

    Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMEDLINE, EMBASE, PsycINFO, DARE, CINAHL, Campbell Collaboration's Social, Psychological, Educational and Criminological Trials Register, and ERIC. We handsearched conference proceedings and publication reference lists for eligible retention trials. We also surveyed all UK Clinical Trials Units to identify further studies. We included eligible retention trials of randomised or quasi-randomised evaluations of strategies to increase retention that were embedded in 'host' randomised trials from all disease areas and healthcare settings. We excluded studies aiming to increase treatment compliance. We contacted authors to supplement or confirm data that we had extracted. For retention trials, we recorded data on the method of randomisation, type of strategy evaluated, comparator, primary outcome, planned sample size, numbers randomised and numbers retained. We used risk ratios (RR) to evaluate the effectiveness of the addition of strategies to improve retention. We assessed heterogeneity between trials using the Chi(2) and I(2) statistics. For main trials that hosted retention trials, we extracted data on disease area, intervention, population, healthcare setting, sequence generation and allocation concealment. We identified 38 eligible retention trials. Included trials evaluated six broad types of strategies to improve retention. These were incentives, communication strategies, new questionnaire format, participant case

  20. Open versus closed surgical exposure of canine teeth that are displaced in the roof of the mouth.

    Science.gov (United States)

    Parkin, Nicola; Benson, Philip E; Thind, Bikram; Shah, Anwar; Khalil, Ismail; Ghafoor, Saiba

    2017-08-21

    databases. We included randomised and quasi-randomised controlled trials assessing young people receiving surgical treatment to correct upper PDCs. There was no restriction on age, presenting malocclusion or type of active orthodontic treatment undertaken. We included unilaterally and bilaterally displaced canines. Two review authors independently screened the results of the electronic searches, extracted data and assessed the risk of bias in the included studies. We attempted to contact study authors for missing data or clarification where feasible. We followed statistical guidelines from the Cochrane Handbook for Systematic Reviews of Interventions for data synthesis. We included three studies, involving 146 participants. Two studies were assessed as being at high risk of bias.The main finding of the review was that the two techniques may be equally successful at exposing PDCs (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.93 to 1.06; three studies, 141 participants analysed, low-quality evidence).One surgical failure was due to detachment of the gold chain (closed group). One study reported on complications following surgery and found two in the closed group: a post-operative infection requiring antibiotics and pain during alignment of the canine as the gold chain penetrated through the gum tissue of the palate.We were unable to pool data for dental aesthetics, patient-reported pain and discomfort, periodontal health and treatment time; however, individual studies did not find any differences between the surgical techniques (low- to very low-quality evidence). Currently, the evidence suggests that neither the open or closed surgical technique for exposing palatally displaced maxillary canine teeth is superior for any of the outcomes included in this review; however, we considered the evidence to be low quality, with two of the three included studies being at high risk of bias. This suggests the need for more high-quality studies. Three ongoing clinical trials have

  1. Driver headway: how close is too close on a motorway?

    Science.gov (United States)

    Brackstone, M; McDonald, M

    2007-08-01

    Driver headway has recently become an important question with much attention being given to unsafe headway or 'tailgating'. This paper reviews a series of recent studies undertaken at the University of Southampton, which have sought to measure and model distance keeping, demonstrating how following distance depends on a wide range of factors, some of which are only recently being explored. These include variations in following distance for any particular driver and the relationship with time to collision, variations in following distances of drivers of differing nationalities and the ability of the driver to 'read the road ahead', which may be affected by interaction with different vehicle types. It is demonstrated that providing clear unequivocal statements regarding car following and safety levels, even after such studies, is still far from straightforward.

  2. Keeping Cool Close to the Sun

    International Nuclear Information System (INIS)

    Hazi, A

    2006-01-01

    The germanium detector in the gamma-ray spectrometer (GRS) aboard the MESSENGER spacecraft is only the size and weight of a can of peaches but will play a critical role in investigating Mercury, the planet closest to the Sun. The MESSENGER (MErcury Surface, Space ENvironment, GEochemistry, and Ranging) spacecraft travels at about 38 kilometers per second and is named after the scientific goals of the mission. It is the first spacecraft to visit Mercury since 1975. MESSENGER must take an oblique route to approach Mercury so that it does not fly past the planet and fall directly into the Sun. The spacecraft will travel 7.9 billion kilometers, flying by Earth once, Venus twice, and Mercury three times before settling into orbit around this mysterious planet. Of all the terrestrial planets, which include Venus, Earth, and Mars, Mercury is the smallest and the densest; its days are 176 Earth days long, two complete orbits of the planet around the Sun. Temperatures range from a high of 450 C on the Sun side during its long day to a low of -185 C on its night side. By studying this extreme planet, scientists hope to better understand how Earth formed and evolved. The GRS, one of the seven lightweight scientific instruments on MESSENGER, will be used to help scientists determine the abundance of elements in Mercury's crust, including the materials that might be ice at its poles. Livermore engineer Norman Madden led the West Coast team effort to design and build the GRS in a collaboration led by Johns Hopkins University Applied Physics Laboratory (JHUAPL). The team included Lawrence Berkeley and Lawrence Livermore national laboratories as well as University of California at Berkeley (UCB) Space Sciences Laboratory (SSL). The JHUAPL MESSENGER project is a National Aeronautics and Space Administration (NASA) Discovery Mission. Because the detector needs to operate at very low temperatures and MESSENGER is close to the Sun, the thermal design to protect the detector was

  3. 75 FR 57476 - National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting

    Science.gov (United States)

    2010-09-21

    ... Communication ] Disorders Special Emphasis Panel, Clinical Trials. Date: October 14, 2010. Time: 11 a.m. to 12 p... HUMAN SERVICES National Institutes of Health National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as...

  4. Metabolites, their decomposition, production of tomato and bioassays from open and closed rockwool systems

    NARCIS (Netherlands)

    Kreij, de C.; Runia, W.T.; Burg, van der A.M.M.

    2004-01-01

    Growth, decrease in yield and other, undefined problems are reported to be due to the recirculation of the nutrient solution, which is compulsory for crops grown on substrates in the Netherlands. In a trial with tomato grown on rockwool, open and closed systems were compared. Drain water from both

  5. Closed system generation of dendritic cells from a single blood volume for clinical application in immunotherapy

    NARCIS (Netherlands)

    Elias, M; van Zanten, J; Hospers, GAP; Setroikromo, A; de Jong, MA; de Leij, LFMH; Mulder, NH

    2005-01-01

    Dendritic cells (DC) used for clinical trials should be processed oil a large scale conforming to current good manufacturing practice (cGM P) guidelines. The aim of this study was to develop a protocol for clinical grade generation of immature DC in a closed-systern. Aphereses were performed with

  6. 77 FR 21789 - National Institute Of Allergy And Infectious Diseases; Notice of Closed Meeting

    Science.gov (United States)

    2012-04-11

    ... Allergy And Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal... Infectious Diseases Special Emphasis Panel; NIAID Clinical Trial Planning Grants and Implementation... Infectious Diseases Research, National Institutes of Health, HHS) Dated: April 4, 2012. Anna P. Snouffer...

  7. 78 FR 24761 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

    Science.gov (United States)

    2013-04-26

    ... Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal... Infectious Diseases Special Emphasis Panel; ``Clinical Trials Units for NIAID Network'' (Meeting 2). Date... Infectious Diseases Research, National Institutes of Health, HHS) Dated: April 22, 2013. David Clary, Program...

  8. 77 FR 45644 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

    Science.gov (United States)

    2012-08-01

    ... Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal... Infectious Diseases Special Emphasis Panel; NIAID Clinical Trial Implementation (U01) Cooperative Agreement..., Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National...

  9. 76 FR 9030 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings

    Science.gov (United States)

    2011-02-16

    ... Allergy and Infectious Diseases Special Emphasis Panel; Genetics of Lupus. Date: March 11, 2011. Time: 11... Allergy and Infectious Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal... Infectious Diseases Special Emphasis Panel; Ancillary Studies in Immunomodulation Clinical Trials (R01). Date...

  10. 76 FR 12744 - National Institute On Deafness and Other Communication Disorders; Notice of Closed Meetings

    Science.gov (United States)

    2011-03-08

    ... Deafness and Other Communication Disorders; Notice of Closed Meetings Pursuant to section 10(d) of the... Deafness and Other Communication Disorders Special Emphasis Panel; Clinical Trials-- Communications. Date..., [email protected] . Name of Committee: National Institute on Deafness and Other Communication Disorders...

  11. 76 FR 62423 - National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings

    Science.gov (United States)

    2011-10-07

    ... Deafness and Other Communication Disorders; Notice of Closed Meetings Pursuant to section 10(d) of the... Deafness and Other Communication Disorders, Special Emphasis Panel, Clinical Trials. Date: October 24, 2011....nih.gov . Name of Committee: National Institute on Deafness and Other Communication Disorders, Special...

  12. 78 FR 56902 - National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings

    Science.gov (United States)

    2013-09-16

    ... Deafness and Other Communication Disorders; Notice of Closed Meetings Pursuant to section 10(d) of the... Deafness and Other Communication Disorders Special Emphasis Panel; Vestibular Clinical Trial Review. Date..., Bethesda, MD 20892, (301) 496-8683, [email protected] . Name of Committee: Communication Disorders...

  13. 78 FR 66946 - National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting

    Science.gov (United States)

    2013-11-07

    ... Deafness and Other Communication Disorders; Notice of Closed Meeting Pursuant to section 10(d) of the... Deafness and Other Communication Disorders Special Emphasis Panel; Hearing Clinical Trial Review. Date... Communicative Disorders, National Institutes of Health, HHS) Dated: November 1, 2013. Melanie J. Gray, Program...

  14. 77 FR 8888 - National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting

    Science.gov (United States)

    2012-02-15

    ... Deafness and Other Communication Disorders; Notice of Closed Meeting Pursuant to section 10(d) of the... Deafness and Other Communication Disorders Special Emphasis Panel, Clinical Trial Review. Date: February 21.... 93.173, Biological Research Related to Deafness and Communicative Disorders, National Institutes of...

  15. 77 FR 35990 - National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings

    Science.gov (United States)

    2012-06-15

    ... Deafness and Other Communication Disorders; Notice of Closed Meetings Pursuant to section 10(d) of the... Deafness and Other Communication Disorders Special Emphasis Panel; Investigator Initiated R01 Review. Date... Institute on Deafness and Other Communication Disorders Special Emphasis Panel; Clinical Trial Review. Date...

  16. 78 FR 56238 - National Center for Complementary and Alternative Medicine; Notice of Closed Meeting

    Science.gov (United States)

    2013-09-12

    ... Complementary and Alternative Medicine; Notice of Closed Meeting Pursuant to section 10(d) of the Federal... Complementary and Alternative Medicine, National Institutes of Health, HHS) Dated: September 6, 2013. Michelle... Alternative Medicine Special Emphasis Panel; ZAT1 PK28: PAR 10-163 R34 Clinical trial planning grants and...

  17. 77 FR 10540 - National Center for Complementary and Alternative Medicine Notice of Closed Meeting

    Science.gov (United States)

    2012-02-22

    ... Complementary and Alternative Medicine Notice of Closed Meeting Pursuant to section 10(d) of the Federal..., Research and Training in Complementary and Alternative Medicine, National Institutes of Health, HHS) Dated... Alternative Medicine Special Emphasis Panel; Research Resource for CAM Clinical Trials. Date: March 15, 2012...

  18. Re-Engineering Alzheimer Clinical Trials: Global Alzheimer's Platform Network.

    Science.gov (United States)

    Cummings, J; Aisen, P; Barton, R; Bork, J; Doody, R; Dwyer, J; Egan, J C; Feldman, H; Lappin, D; Truyen, L; Salloway, S; Sperling, R; Vradenburg, G

    2016-06-01

    Alzheimer's disease (AD) drug development is costly, time-consuming, and inefficient. Trial site functions, trial design, and patient recruitment for trials all require improvement. The Global Alzheimer Platform (GAP) was initiated in response to these challenges. Four GAP work streams evolved in the US to address different trial challenges: 1) registry-to-cohort web-based recruitment; 2) clinical trial site activation and site network construction (GAP-NET); 3) adaptive proof-of-concept clinical trial design; and 4) finance and fund raising. GAP-NET proposes to establish a standardized network of continuously funded trial sites that are highly qualified to perform trials (with established clinical, biomarker, imaging capability; certified raters; sophisticated management system. GAP-NET will conduct trials for academic and biopharma industry partners using standardized instrument versions and administration. Collaboration with the Innovative Medicines Initiative (IMI) European Prevention of Alzheimer's Disease (EPAD) program, the Canadian Consortium on Neurodegeneration in Aging (CCNA) and other similar international initiatives will allow conduct of global trials. GAP-NET aims to increase trial efficiency and quality, decrease trial redundancy, accelerate cohort development and trial recruitment, and decrease trial costs. The value proposition for sites includes stable funding and uniform training and trial execution; the value to trial sponsors is decreased trial costs, reduced time to execute trials, and enhanced data quality. The value for patients and society is the more rapid availability of new treatments for AD.

  19. TIDAL EVOLUTION OF CLOSE-IN PLANETS

    International Nuclear Information System (INIS)

    Matsumura, Soko; Rasio, Frederic A.; Peale, Stanton J.

    2010-01-01

    Recent discoveries of several transiting planets with clearly non-zero eccentricities and some large obliquities started changing the simple picture of close-in planets having circular and well-aligned orbits. The two major scenarios that form such close-in planets are planet migration in a disk and planet-planet interactions combined with tidal dissipation. The former scenario can naturally produce a circular and low-obliquity orbit, while the latter implicitly assumes an initially highly eccentric and possibly high-obliquity orbit, which are then circularized and aligned via tidal dissipation. Most of these close-in planets experience orbital decay all the way to the Roche limit as previous studies showed. We investigate the tidal evolution of transiting planets on eccentric orbits, and find that there are two characteristic evolution paths for them, depending on the relative efficiency of tidal dissipation inside the star and the planet. Our study shows that each of these paths may correspond to migration and scattering scenarios. We further point out that the current observations may be consistent with the scattering scenario, where the circularization of an initially eccentric orbit occurs before the orbital decay primarily due to tidal dissipation in the planet, while the alignment of the stellar spin and orbit normal occurs on a similar timescale to the orbital decay largely due to dissipation in the star. We also find that even when the stellar spin-orbit misalignment is observed to be small at present, some systems could have had a highly misaligned orbit in the past, if their evolution is dominated by tidal dissipation in the star. Finally, we also re-examine the recent claim by Levrard et al. that all orbital and spin parameters, including eccentricity and stellar obliquity, evolve on a similar timescale to orbital decay. This counterintuitive result turns out to have been caused by a typo in their numerical code. Solving the correct set of tidal

  20. Exploring the ethical and regulatory issues in pragmatic clinical trials.

    Science.gov (United States)

    Califf, Robert M; Sugarman, Jeremy

    2015-10-01

    The need for high-quality evidence to support decision making about health and health care by patients, physicians, care providers, and policy-makers is well documented. However, serious shortcomings in evidence persist. Pragmatic clinical trials that use novel techniques including emerging information and communication technologies to explore important research questions rapidly and at a fraction of the cost incurred by more "traditional" research methods promise to help close this gap. Nevertheless, while pragmatic clinical trials can bridge clinical practice and research, they may also raise difficult ethical and regulatory challenges. In this article, the authors briefly survey the current state of evidence that is available to inform clinical care and other health-related decisions and discuss the potential for pragmatic clinical trials to improve this state of affairs. They then propose a new working definition for pragmatic research that centers upon fitness for informing decisions about health and health care. Finally, they introduce a project, jointly undertaken by the National Institutes of Health Health Care Systems Research Collaboratory and the National Patient-Centered Clinical Research Network (PCORnet), which addresses 11 key aspects of current systems for regulatory and ethical oversight of clinical research that pose challenges to conducting pragmatic clinical trials. In the series of articles commissioned on this topic published in this issue of Clinical Trials, each of these aspects is addressed in a dedicated article, with a special focus on the interplay between ethical and regulatory considerations and pragmatic clinical research aimed at informing "real-world" choices about health and health care. © The Author(s) 2015.

  1. Method and apparatus for operating a powertrain system upon detecting a stuck-closed clutch

    Science.gov (United States)

    Hansen, R. Anthony

    2014-02-18

    A powertrain system includes a multi-mode transmission having a plurality of torque machines. A method for controlling the powertrain system includes identifying all presently applied clutches including commanded applied clutches and the stuck-closed clutch upon detecting one of the torque-transfer clutches is in a stuck-closed condition. A closed-loop control system is employed to control operation of the multi-mode transmission accounting for all the presently applied clutches.

  2. On H-closed and U-closed functions | Cammaroto | Quaestiones ...

    African Journals Online (AJOL)

    In this article, we extend the work on H-closed functions started by Cammaroto, Fedorchuk and Porter in 1998. Also, U-closed functions are introduced and characterized in terms of filters and adherence. The hereditary and productivity properties are examined and developed for both H-closed and U-closed functions.

  3. Factors predicting publication of spinal cord injury trials registered on www.ClinicalTrials. gov.

    Science.gov (United States)

    DePasse, J Mason; Park, Sara; Eltorai, Adam E M; Daniels, Alan H

    2018-02-06

    Treatment options for spinal cord injuries are currently limited, but multiple clinical trials are underway for a variety of interventions, drugs, and devices. The Food and Drug Administration website www.ClinicalTrials.gov catalogues these trials and includes information on the status of the trial, date of initiation and completion, source of funding, and region. This investigation assesses the factors associated with publication and the publication rate of spinal cord injury trials. Retrospective analysis of publically available data on www.ClinicalTrials.gov. The www.ClinicalTrials.gov was queried for all trials on patients with spinal cord injury, and these trials were assessed for status, type of intervention, source of funding, and region. Multiple literature searches were performed on all completed trials to determine publication status. There were 626 studies identified concerning the treatment of patients with spinal cord injury, of which 250 (39.9%) were completed. Of these, only 119 (47.6%) were published. There was no significant difference in the rate of publication between regions (p> 0.16) or by study type (p> 0.29). However, trials that were funded by the NIH were more likely to be published than trials funded by industry (p= 0.01). The current publication rate of spinal cord injury trials is only 47.6%, though this rate is similar to the publication rate for trials in other fields. NIH-funded trials are significantly more likely to become published than industry-funded trials, which could indicate that some trials remain unpublished due to undesirable results. However, it is also likely that many trials on spinal cord injury yield negative results, as treatments are often ineffective.

  4. Oriented open-closed string theory revisited

    International Nuclear Information System (INIS)

    Zwiebach, B.

    1998-01-01

    String theory on D-brane backgrounds is open-closed string theory. Given the relevance of this fact, we give details and elaborate upon our earlier construction of oriented open-closed string field theory. In order to incorporate explicitly closed strings, the classical sector of this theory is open strings with a homotopy associative A ∞ algebraic structure. We build a suitable Batalin-Vilkovisky algebra on moduli spaces of bordered Ricmann surfaces, the construction of which involves a few subtleties arising from the open string punctures and cyclicity conditions. All vertices coupling open and closed strings through disks are described explicitly. Subalgebras of the algebra of surfaces with boundaries are used to discuss symmetries of classical open string theory induced by the closed string sector, and to write classical open string field theory on general closed string backgrounds. We give a preliminary analysis of the ghost-dilaton theorem. copyright 1998 Academic Press, Inc

  5. Risk of bias assessment of randomised controlled trials in high-impact ophthalmology journals and general medical journals: a systematic review.

    Science.gov (United States)

    Joksimovic, Lazar; Koucheki, Robert; Popovic, Marko; Ahmed, Yusuf; Schlenker, Matthew B; Ahmed, Iqbal Ike K

    2017-10-01

    Evidence-based treatments in ophthalmology are often based on the results of randomised controlled trials. Biased conclusions from randomised controlled trials may lead to inappropriate management recommendations. This systematic review investigates the prevalence of bias risk in randomised controlled trials published in high-impact ophthalmology journals and ophthalmology trials from general medical journals. Using Ovid MEDLINE, randomised controlled trials in the top 10 high-impact ophthalmology journals in 2015 were systematically identified and critically appraised for the prevalence of bias risk. Included randomised controlled trials were assessed in all domains of bias as defined by the Cochrane Collaboration. In addition, the prevalence of conflict of interest and industry sponsorship was investigated. A comparison with ophthalmology articles from high-impact general medical journals was performed. Of the 259 records that were screened from ophthalmology-specific journals, 119 trials met all inclusion criteria and were critically appraised. In total, 29.4% of domains had an unclear risk, 13.8% had a high risk and 56.8% had a low risk of bias. In comparison, ophthalmology articles from general medical journals had a lower prevalence of unclear risk (17.1%), higher prevalence of high risk (21.9%) and a higher prevalence of low risk domains (61.9%). Furthermore, 64.7% of critically appraised trials from ophthalmology-specific journals did not report any conflicts of interest, while 70.6% did not report an industry sponsor of their trial. In closing, it is essential that authors, peer reviewers and readers closely follow published risk of bias guidelines. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  6. Close range photogrammetry and machine vision

    CERN Document Server

    Atkinson, KB

    1996-01-01

    This book presents the methodology, algorithms, techniques and equipment necessary to achieve real time digital photogrammetric solutions, together with contemporary examples of close range photogrammetry.

  7. Is Blindness Close to Death?

    Directory of Open Access Journals (Sweden)

    Elif Demirkılınç Biler

    2014-12-01

    Full Text Available The association between visual impairment and mortality has been reported in many studies. As well as some ocular diseases may be associated with increased mortality directly, visual impairment is also reportedly associated with many factors linked to higher risk of dying via indirect pathways. These include unintentional injury and increased risk of falls, reduced walking speed, lower body mass index, self-reported difficulty in physical activity and nutrition, cardiovascular diseases and even cancer, dementia, anxiety, depression, and reduced social interaction. Visual impairment also severely affect a person’s self-ranking of his or her health. Correction for these confounders has been found to attenuate the association between visual impairment and mortality, but the real mechanisms behind the association between visual impairment and mortality is still unclear. The impact of visual impairment on mortality with the decreased quality of life is an important health problem, and the ophthalmologists should be aware of it. In this review, we summarize all studies related to this subject in different patient populations. (Turk J Ophthalmol 2014; 44: 471-5

  8. Map of open and closed chromatin domains in Drosophila genome.

    Science.gov (United States)

    Milon, Beatrice; Sun, Yezhou; Chang, Weizhong; Creasy, Todd; Mahurkar, Anup; Shetty, Amol; Nurminsky, Dmitry; Nurminskaya, Maria

    2014-11-18

    Chromatin compactness has been considered a major determinant of gene activity and has been associated with specific chromatin modifications in studies on a few individual genetic loci. At the same time, genome-wide patterns of open and closed chromatin have been understudied, and are at present largely predicted from chromatin modification and gene expression data. However the universal applicability of such predictions is not self-evident, and requires experimental verification. We developed and implemented a high-throughput analysis for general chromatin sensitivity to DNase I which provides a comprehensive epigenomic assessment in a single assay. Contiguous domains of open and closed chromatin were identified by computational analysis of the data, and correlated to other genome annotations including predicted chromatin "states", individual chromatin modifications, nuclear lamina interactions, and gene expression. While showing that the widely trusted predictions of chromatin structure are correct in the majority of cases, we detected diverse "exceptions" from the conventional rules. We found a profound paucity of chromatin modifications in a major fraction of closed chromatin, and identified a number of loci where chromatin configuration is opposite to that expected from modification and gene expression patterns. Further, we observed that chromatin of large introns tends to be closed even when the genes are expressed, and that a significant proportion of active genes including their promoters are located in closed chromatin. These findings reveal limitations of the existing predictive models, indicate novel mechanisms of epigenetic regulation, and provide important insights into genome organization and function.

  9. 29 CFR 541.703 - Directly and closely related.

    Science.gov (United States)

    2010-07-01

    ... of exempt duties may also include recordkeeping; monitoring and adjusting machinery; taking notes... and making decisions; and using a photocopier or fax machine. Work is not “directly and closely... may take extensive notes recording the flow of work and materials through the office or plant of the...

  10. 34 CFR 685.214 - Closed school discharge.

    Science.gov (United States)

    2010-07-01

    ... the school's closing with any third party, such as the holder of a performance bond or a tuition... their successors, its sureties, and any private fund, including the portion of a public fund that represents funds received from a private party. (2) The provisions of this section apply notwithstanding any...

  11. 29 CFR 2701.7 - Expedited closing procedure.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Expedited closing procedure. 2701.7 Section 2701.7 Labor Regulations Relating to Labor (Continued) FEDERAL MINE SAFETY AND HEALTH REVIEW COMMISSION GOVERNMENT IN THE... policy of the Commission to open to the public meetings that may be subject to closure, including...

  12. FINAL CLOSE-OUT REPORT

    Energy Technology Data Exchange (ETDEWEB)

    Mark A. Carl

    2004-08-03

    The Interstate Oil and Gas Compact Commission (IOGCC) engaged in numerous projects outlined under the scope of work discussed in the United States Department of Energy (DOE) grant number DE-FG26-01BC15336 awarded to the IOGCC. Numerous projects were completed that were extremely valuable to state oil and gas agencies as a result of work performed utilizing resources provided by the grant. There are numerous areas in which state agencies still need assistance. This additional assistance will need to be addressed under another grant because funding resources have been exhausted under The scope of work objectives for the eight projects covered under this grant is as follows: (1) Improve uniformity within state oil and gas data management efforts. (2) Conduct environmental compliance workshops and related educational projects on natural gas and oil exploration and production. (3) Improve regulatory efficiency through partnering opportunities provided by the Appalachian Illinois Basin Directors. (4) Promote the development and implementation of risk-based environmental regulation at the state level through an expertise-sharing program that brings stakeholders together to develop guidelines and models to meet regulatory challenges. (5) Support the IOGCC's regulatory streamlining efforts, including the identification and elimination of unnecessary duplications of effort between state and federal programs dealing with exploration and production on public lands, and identify the need to enhance and regionalize regulatory coordination and cooperation among the states. (6) Involve states and provinces of Canada that have offshore petroleum exploration and production in a regulatory sharing alliance to identify areas of concern that may be incorporated into standard practices for offshore environmental and regulatory compliance. (7) Coordinate efforts with the U.S. Environmental Protection Agency (EPA) to ensure that adequate information is available to the public

  13. Statistical controversies in clinical research: requiem for the 3 + 3 design for phase I trials.

    Science.gov (United States)

    Paoletti, X; Ezzalfani, M; Le Tourneau, C

    2015-09-01

    More than 95% of published phase I trials have used the 3 + 3 design to identify the dose to be recommended for phase II trials. However, the statistical community agrees on the limitations of the 3 + 3 design compared with model-based approaches. Moreover, the mechanisms of action of targeted agents strongly challenge the hypothesis that the maximum tolerated dose constitutes the optimal dose, and more outcomes including clinical and biological activity increasingly need to be taken into account to identify the optimal dose. We review key elements from clinical publications and from the statistical literature to show that the 3 + 3 design lacks the necessary flexibility to address the challenges of targeted agents. The design issues raised by expansion cohorts, new definitions of dose-limiting toxicity and trials of combinations are not easily addressed by the 3 + 3 design or its extensions. Alternative statistical proposals have been developed to make a better use of the complex data generated by phase I trials. Their applications require a close collaboration between all actors of early phase clinical trials. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  14. Published intimate partner violence studies often differ from their trial registration records.

    Science.gov (United States)

    Madden, Kim; Tai, Kerry; Ali, Zak; Schneider, Patricia; Singh, Mahip; Ghert, Michelle; Bhandari, Mohit

    2017-12-27

    Registering study protocols in a trial registry is important for methodologic transparency and reducing selective reporting bias. The objective of this investigation was to determine whether published studies of intimate partner violence (IPV) that had been registered matched the registration record on key study design elements. We systematically searched three trial registries to identify registered IPV studies and the published literature for the associated publication. Two authors independently determined for each study whether key study elements in the registry matched those in the published paper. We included 66 studies published between 2006 and 2017. Nearly half (29/66, 44%) were registered after study completion. Many (26/66, 39%) had discrepancies regarding the primary outcome, and nearly two-thirds (42/66, 64%) had discrepancies in secondary outcomes. Discrepancies in study design were less frequent (13/66, 20%). However, large changes in sample size (26/66, 39%) and discrepancies in funding source (28/66, 42%) were frequently observed. Trial registries are important tools for research transparency and identifying and preventing outcome switching and selective outcome reporting bias. Published IPV studies often differ from their records in trial registries. Researchers should pay close attention to the accuracy of trial registry records.

  15. Methodology series module 4: Clinical trials

    Directory of Open Access Journals (Sweden)

    Maninder Singh Setia

    2016-01-01

    Full Text Available In a clinical trial, study participants are (usually divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care. We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1 parallel study design, (2 cross-over design, (3 factorial design, and (4 withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials. Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

  16. Identification of additional trials in prospective trial registers for Cochrane systematic reviews.

    Directory of Open Access Journals (Sweden)

    Wynanda A van Enst

    Full Text Available BACKGROUND: Publication and selective outcome reporting bias are a threat to the validity of systematic reviews. Extensive searching for additional trials in prospective trial registers could reduce this problem. We have evaluated how authors of Cochrane systematic reviews currently make use of trial registers as an additional source for the identification of potentially eligible trials. METHODOLOGY/PRINCIPAL FINDINGS: We included 210 systematic Cochrane reviews of interventions published between 2008 and 2010 of which the protocol was first published in 2008. When prospective trial registers were searched we recorded the names of the register(s, the authors' motive(s and if they yielded any extra trials. In 80 reviews (38.1% the authors had searched in one or more prospective trial register(s of which 55% had searched in overlapping search portals and individual registers. Most frequently assessed were the MetaRegister (66.3% and Clinicaltrials.gov (60% which is in sharp contrast of other registers or portals like the WHO ICTRP Search Portal (20%. Reported motives to use registers were to identify ongoing trials (83.3%, to identify unpublished outcomes or trials (23.5%, to identify recently published trials (11.8%, or to identify any relevant trial (3.9%.In 28 reviews (35% the authors had selected (ongoing trials identified in trial registers as potentially eligible. DISCUSSION: Trial registers as an additional source of information are gaining acknowledgement amongst Cochrane reviewers. Nevertheless, searches seem to be inefficient as overlapping databases are frequently consulted, while the WHO ICTRP Search Portal that includes the data from all approved registers worldwide is being underused. Moreover, the emphasis is now on the identification of ongoing trials, although the prospective registers offer a broader potential. Further familiarity of registers and guidance how to search and to report will help to implement this as a common method

  17. Glueballs as rotating folded closed strings

    Science.gov (United States)

    Sonnenschein, Jacob; Weissman, Dorin

    2015-12-01

    In previous papers [1, 2] we argued that mesons and baryons can be described as rotating open strings in holographic backgrounds. Now we turn to closed strings, which should be the duals of glueballs. We look at the rotating folded closed string in both flat and curved backgrounds.

  18. Climatic evaluation of semi-closed greenhouses

    NARCIS (Netherlands)

    Campen, J.B.; Kempkes, F.L.K.

    2011-01-01

    In the Netherlands the development of semi-closed greenhouses is going on for eight years. Increased carbon dioxide levels, reduced pesticide use, and energy saving are the main benefits of semi-closed greenhouses. Companies have developed several concepts with the goal to reduce the ventilation

  19. 22 CFR 708.5 - Closed meetings.

    Science.gov (United States)

    2010-04-01

    ... of a criminal investigation, or by an agency conducting a lawful national security intelligence... business day next succeeding the day of the vote taken pursuant to paragraph (c)(1) or (c)(2) of this... Closed meetings. (a) Meetings of the Board of Directors will be closed to public observation where the...

  20. 76 FR 67498 - Post Office Closing

    Science.gov (United States)

    2011-11-01

    ... POSTAL REGULATORY COMMISSION [Docket No. A2012-17; Order No. 918] Post Office Closing AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: This document informs the public that an appeal of the closing of the Venice, California post office has been filed. It identifies preliminary steps and...

  1. A Public Trial De Novo

    DEFF Research Database (Denmark)

    Vedel, Jane Bjørn; Gad, Christopher

    2011-01-01

    This article addresses the concept of “industrial interests” and examines its role in a topical controversy about a large research grant from a private foundation, the Novo Nordisk Foundation, to the University of Copenhagen. The authors suggest that the debate took the form of a “public trial......” where the grant and close(r) intermingling between industry and public research was prosecuted and defended. First, the authors address how the grant was framed in the media. Second, they redescribe the case by introducing new “evidence” that, because of this framing, did not reach “the court...

  2. A and B Theories of Closed Time

    Directory of Open Access Journals (Sweden)

    Phill Dowe

    Full Text Available ABSTRACT Closed time is possible in several senses of ‘possible’. One might like to know, therefore, whether closed time is possible in the sense that it is compatible with standard metaphysical theories of time. In this paper I am concerned with whether closed time is compatible with A and/or B theories of time. A common enough view amongst philosophers is that B theories do but A theories do not allow closed time. However, I show that prima-facie neither approach allows closed time, but that with a little work standard versions of both approaches do. This shows that there’s no special problem with the notion of eternal return.

  3. TV News Magazine Presentation: Close Up Gendai by NHK (2010)

    CERN Multimedia

    2011-01-01

    In this episode of Close Up Gendai, dark matter is the subject of investigation and one of the unsolved mysteries of the Universe. The show highlights the research being done around the globe to try to understand dark matter, including the research happening at the XMASS experiment in Japan, the Cryogenic Dark Matter Search experiment in the US, as well as CERN’s LHC experiments. Close Up Gendai will be presented on Friday, 8 April from 13:00 to 13:30 in the Council Chamber Language: Japanese  

  4. Detection of HBV Covalently Closed Circular DNA

    Directory of Open Access Journals (Sweden)

    Xiaoling Li

    2017-06-01

    Full Text Available Chronic hepatitis B virus (HBV infection affects approximately 240 million people worldwide and remains a serious public health concern because its complete cure is impossible with current treatments. Covalently closed circular DNA (cccDNA in the nucleus of infected cells cannot be eliminated by present therapeutics and may result in persistence and relapse. Drug development targeting cccDNA formation and maintenance is hindered by the lack of efficient cccDNA models and reliable cccDNA detection methods. Southern blotting is regarded as the gold standard for quantitative cccDNA detection, but it is complicated and not suitable for high-throughput drug screening, so more sensitive and simple methods, including polymerase chain reaction (PCR-based methods, Invader assays, in situ hybridization and surrogates, have been developed for cccDNA detection. However, most methods are not reliable enough, and there are no unified standards for these approaches. This review will summarize available methods for cccDNA detection. It is hoped that more robust methods for cccDNA monitoring will be developed and that standard operation procedures for routine cccDNA detection in scientific research and clinical monitoring will be established.

  5. Coccolithophorid algae culture in closed photobioreactors.

    Science.gov (United States)

    Moheimani, Navid R; Isdepsky, Andreas; Lisec, Jan; Raes, Eric; Borowitzka, Michael A

    2011-09-01

    The feasibility of growth, calcium carbonate and lipid production of the coccolithophorid algae (Prymnesiophyceae), Pleurochrysis carterae, Emiliania huxleyi, and Gephyrocapsa oceanica, was investigated in plate, carboy, airlift, and tubular photobioreactors. The plate photobioreactor was the most promising closed cultivation system. All species could be grown in the carboy photobioreactor. However, P. carterae was the only species which grew in an airlift photobioreactor. Despite several attempts to grow these coccolithophorid species in the tubular photobioreactor (Biocoil), including modification of the airlift and sparger design, no net growth could be achieved. The shear produced by turbulence and bubble effects are the most likely reasons for this failure to grow in the Biocoil. The highest total dry weight, lipid and calcium carbonate productivities achieved by P. carterae in the plate photobioreactors were 0.54, 0.12, and 0.06 g L(-1) day(-1) respectively. Irrespective of the type of photobioreactor, the productivities were P. carterae > E. huxleyi > G. oceanica. Pleurochrysis carterae lipid (20-25% of dry weight) and calcium carbonate (11-12% of dry weight) contents were also the highest of all species tested. Copyright © 2011 Wiley Periodicals, Inc.

  6. Final environmental statement for selection of the preferred closed cycle cooling system at Indian Point Unit No. 3, Docket No. 50-286

    International Nuclear Information System (INIS)

    1979-12-01

    The environmental statement includes information concerning the alternative closed cycle cooling systems; schedule and permits; environmental impacts of feasible alternative closed cycle cooling systems; socio-economic impact of closed cycle cooling systems; and evaluation of proposed action

  7. Effect of Industry Sponsorship on Dental Restorative Trials.

    Science.gov (United States)

    Schwendicke, F; Tu, Y-K; Blunck, U; Paris, S; Göstemeyer, G

    2016-01-01

    Industry sponsorship was found to potentially introduce bias into clinical trials. We assessed the effects of industry sponsorship on the design, comparator choice, and findings of randomized controlled trials on dental restorative materials. A systematic review was performed via MEDLINE, CENTRAL, and EMBASE. Randomized trials on dental restorative and adhesive materials published 2005 to 2015 were included. The design of sponsored and nonsponsored trials was compared statistically (risk of bias, treatment indication, setting, transferability, sample size). Comparator choice and network geometry of sponsored and nonsponsored trials were assessed via network analysis. Material performance rankings in different trial types were estimated via Bayesian network meta-analysis. Overall, 114 studies were included (15,321 restorations in 5,232 patients). We found 21 and 41 (18% and 36%) trials being clearly or possibly industry sponsored, respectively. Trial design of sponsored and nonsponsored trials did not significantly differ for most assessed items. Sponsored trials evaluated restorations of load-bearing cavities significantly more often than nonsponsored trials, had longer follow-up periods, and showed significantly increased risk of detection bias. Regardless of sponsorship status, comparisons were mainly performed within material classes. The proportion of trials comparing against gold standard restorative or adhesive materials did not differ between trial types. If ranked for performance according to the need to re-treat (best: least re-treatments), most material combinations were ranked similarly in sponsored and nonsponsored trials. The effect of industry sponsorship on dental restorative trials seems limited. © International & American Associations for Dental Research 2015.

  8. An open mind to closed borders

    Science.gov (United States)

    Fallet, Ulrike; Lefeber, Bob

    2017-04-01

    One aspect of "Science in tomorrow's classroom" is teaching geography students the basic skills and knowledge to play an active role in society as citizens. Topics that frame the development of good citizenship are wide-ranged and include climate change, migration and integration as well as democracy and identity. Often these kinds of topics do not allow for right or wrong answers or classroom lectures; it is more important to encourage students to find and discuss arguments with which to underpin their opinion. In this way, civic education is very suitable for active learning. Active learning is described as a method of learning in which students are actively involved in the learning process through (group) discussion, experiments or games. By doing so, students are stimulated to engage in higher-order thinking tasks such as analysis, synthesis, and evaluation, which are inherent to becoming responsible, reflective and critical citizens as well as (future) scientists. It has also been shown that the use of active learning methods significantly increased the number of meaningful geographical relationships that students give in tests (Karkdijk, 2012). I, therefore, propose to use active learning to approach civic education in the classroom. Specifically, I used a "mystery" to engage students in active learning on the highly polarizing subject of migration. A mystery (Leat, 1990) is a didactic method that uses short bits of information to solve an intriguing question. A current polarizing subject in society and in the classroom is the migration from Northern Africa and the Middle East to Europe and the increasing number of terrorist attacks by individuals who have radicalised before, during or after their journey over the Mediterranean. In class, students were asked to solve this migration mystery: "Could the terrorist attack in Berlin have been stopped by closing the borders of the Mediterranean countries to migrants?" In order to solve this mystery and to find an

  9. Making co-enrolment feasible for randomised controlled trials in paediatric intensive care.

    Directory of Open Access Journals (Sweden)

    Katie Harron

    Full Text Available Enrolling children into several trials could increase recruitment and lead to quicker delivery of optimal care in paediatric intensive care units (PICU. We evaluated decisions taken by clinicians and parents in PICU on co-enrolment for two large pragmatic trials: the CATCH trial (CATheters in CHildren comparing impregnated with standard central venous catheters (CVCs for reducing bloodstream infection in PICU and the CHIP trial comparing tight versus standard control of hyperglycaemia.We recorded the period of trial overlap for all PICUs taking part in both CATCH and CHiP and reasons why clinicians decided to co-enrol children or not into both studies. We examined parental decisions on co-enrolment by measuring recruitment rates and reasons for declining consent.Five PICUs recruited for CATCH and CHiP during the same period (an additional four opened CATCH after having closed CHiP. Of these five, three declined co-enrolment (one of which delayed recruiting elective patients for CATCH whilst CHiP was running, due to concerns about jeopardising CHiP recruitment, asking too much of parents, overwhelming amounts of information to explain to parents for two trials and a policy against co-enrolment. Two units co-enrolled in order to maximise recruitment to both trials. At the first unit, 35 parents were approached for both trials. 17/35 consented to both; 13/35 consented to one trial only; 5/35 declined both. Consent rates during co-enrolment were 29/35 (82% and 18/35 (51% for CATCH and CHiP respectively compared with 78% and 51% respectively for those approached for a single trial within this PICU. The second unit did not record data on approaches or refusals, but successfully co-enrolled one child.Co-enrolment did not appear to jeopardise recruitment or overwhelm parents. Strategies for seeking consent for multiple trials need to be developed and should include how to combine information for parents and patients.

  10. Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary analysis

    Science.gov (United States)

    2014-01-01

    Background There is growing recognition of the value of conducting qualitative research with trials in health research. It is timely to reflect on how this qualitative research is presented in grant proposals to identify lessons for researchers and research commissioners. As part of a larger study focusing on how to maximise the value of undertaking qualitative research with trials, we undertook a documentary analysis of proposals of funded studies. Methods Using the metaRegister of Controlled Trials (mRCT) database we identified trials funded in the United Kingdom, ongoing between 2001 and 2010, and reporting the use of qualitative research. We requested copies of proposals from lead researchers. We extracted data from the proposals using closed and open questions, analysed using descriptive statistics and content analysis respectively. Results 2% (89/3812) of trials in the mRCT database described the use of qualitative research undertaken with the trial. From these 89 trials, we received copies of 36 full proposals, of which 32 met our inclusion criteria. 25% used less than a single paragraph to describe the qualitative research. The aims of the qualitative research described in these proposals focused mainly on the intervention or trial conduct. Just over half (56%) of the proposals included an explicit rationale for conducting the qualitative research with the trial, the most frequent being to optimise implementation into clinical practice or to interpret trial findings. Key information about methods, expertise and resources was missing in a large minority of proposals, in particular sample size, type of analysis, and non-personnel resources. 28% specifically stated that qualitative researchers would conduct the qualitative research. Conclusions Our review of proposals of successfully funded studies identified good practice but also identified limited space given to describing the qualitative research, with an associated lack of attention to the rationale for

  11. Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary analysis.

    Science.gov (United States)

    Drabble, Sarah J; O'Cathain, Alicia; Thomas, Kate J; Rudolph, Anne; Hewison, Jenny

    2014-02-18

    There is growing recognition of the value of conducting qualitative research with trials in health research. It is timely to reflect on how this qualitative research is presented in grant proposals to identify lessons for researchers and research commissioners. As part of a larger study focusing on how to maximise the value of undertaking qualitative research with trials, we undertook a documentary analysis of proposals of funded studies. Using the metaRegister of Controlled Trials (mRCT) database we identified trials funded in the United Kingdom, ongoing between 2001 and 2010, and reporting the use of qualitative research. We requested copies of proposals from lead researchers. We extracted data from the proposals using closed and open questions, analysed using descriptive statistics and content analysis respectively. 2% (89/3812) of trials in the mRCT database described the use of qualitative research undertaken with the trial. From these 89 trials, we received copies of 36 full proposals, of which 32 met our inclusion criteria. 25% used less than a single paragraph to describe the qualitative research. The aims of the qualitative research described in these proposals focused mainly on the intervention or trial conduct. Just over half (56%) of the proposals included an explicit rationale for conducting the qualitative research with the trial, the most frequent being to optimise implementation into clinical practice or to interpret trial findings. Key information about methods, expertise and resources was missing in a large minority of proposals, in particular sample size, type of analysis, and non-personnel resources. 28% specifically stated that qualitative researchers would conduct the qualitative research. Our review of proposals of successfully funded studies identified good practice but also identified limited space given to describing the qualitative research, with an associated lack of attention to the rationale for doing the qualitative research and

  12. 7 CFR 1927.56 - Scheduling loan closing.

    Science.gov (United States)

    2010-01-01

    ... REGULATIONS TITLE CLEARANCE AND LOAN CLOSING Real Estate Title Clearance and Loan Closing § 1927.56 Scheduling loan closing. The agency, in coordination with the closing agent, will arrange a loan closing and send loan closing instructions, on an agency form to the closing agent when the agency determines that the...

  13. Birth Control in Clinical Trials

    Science.gov (United States)

    Stewart, J.; Beyer, B. K.; Chadwick, K.; De Schaepdrijver, L.; Desai, M.; Enright, B.; Foster, W.; Hui, J. Y.; Moffat, G. J.; Tornesi, B.; Van Malderen, K.; Wiesner, L.; Chen, C. L.

    2015-01-01

    The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives. PMID:27042398

  14. SOFIA Closed- and Open-Door Aerodynamic Analyses

    Science.gov (United States)

    Cumming, Stephen; Frederick, Mike; Smith, Mark

    2012-01-01

    Work to evaluate the aerodynamic characteristics and the cavity acoustic environment of the SOFIA (Stratospheric Observatory for Infrared Astronomy) airplane has been completed. The airplane has been evaluated in its closed-door configuration, as well as several open-door configurations. Work performed included: acoustic analysis tool development, cavity acoustic evaluation, stability and control parameter estimation, air data calibration, and external flow evaluation. Qualitative airflow data were obtained during the closed- and open-door flights using tufts on the aft portion of the fuselage. Video was taken from a chase plane. This video was analyzed for various flight conditions, and general flow descriptions of the aft fuselage of the 747SP were developed for the different closed and open door configurations.

  15. Closed central slip injuries--a missed diagnosis?

    LENUS (Irish Health Repository)

    Nugent, N

    2011-09-01

    The extensor apparatus of the finger is a complex structure and injury can lead to significant digital dysfunction. Closed central slip injuries may be missed or diagnosis delayed because of lack of an open wound and often no radiographic abnormality, and can result in boutonniere deformities if untreated. This study aimed to quantify the number of patients attending with closed central slip injuries and to ascertain if the initial diagnosis was correct. The number of patients presenting to us over a 6 month period was recorded. The original diagnosis, time to diagnosis of central slip injury and the presence\\/absence of a boutonniere deformity were recorded. Ten patients were included in the study. Seven (70%) injuries were due to sport. Eight (80%) had a delayed diagnosis of central slip injury. Six (60%) had previously presented to general practitioners or emergency departments. Seven (70%) had boutonniere deformities. Closed central slip injuries can be missed. Simple clinical tests can diagnose central slip disruption.

  16. Sensor modelling and camera calibration for close-range photogrammetry

    Science.gov (United States)

    Luhmann, Thomas; Fraser, Clive; Maas, Hans-Gerd

    2016-05-01

    Metric calibration is a critical prerequisite to the application of modern, mostly consumer-grade digital cameras for close-range photogrammetric measurement. This paper reviews aspects of sensor modelling and photogrammetric calibration, with attention being focussed on techniques of automated self-calibration. Following an initial overview of the history and the state of the art, selected topics of current interest within calibration for close-range photogrammetry are addressed. These include sensor modelling, with standard, extended and generic calibration models being summarised, along with non-traditional camera systems. Self-calibration via both targeted planar arrays and targetless scenes amenable to SfM-based exterior orientation are then discussed, after which aspects of calibration and measurement accuracy are covered. Whereas camera self-calibration is largely a mature technology, there is always scope for additional research to enhance the models and processes employed with the many camera systems nowadays utilised in close-range photogrammetry.

  17. Dieter Kiessling. Closed-Circuit Video 1982 – 2000

    DEFF Research Database (Denmark)

    Kacunko, Slavko

    2001-01-01

    Whitehead’s critique of instantaneity (closed circuit technique still being generally known under the term of ‘Instant Feedback’ at the time) and his inferences of process philosophy, can, at least as an implication, be sensed in Dieter Kiessling’s closed-circuit video installations. Some...... this digital and other, ‘analog’ options. The viewer is continually challenged to discover principles of order – in time, topology, technology and other spheres – thus confirming the artistic intention of reassessing not only these but also the relation between work and beholder; of providing that viewer...... with active access to the medium and retrospectively to his/her own ‘mechanisms’ including the personal constructs of reality. Luhmann’s operative systems theory thus co-incides with the ‘structuralism’ of Kiessling’s closed-circuit video installations with their foundations of ‘self-reference’. They seek...

  18. Centralized National Ethical Review of Clinical Trials in Croatia

    Science.gov (United States)

    Vitezić, Dinko; Lovrek, Maja; Tomić, Siniša

    2009-01-01

    Aim To present the Croatian system of ethical review of clinical trials and assessment outcomes of the applications reviewed by the Croatian Central Ethics Committee. Methods Clinical trial applications reviewed by the Croatian Central Ethics Committee, which has the legal mandate to review clinical trials of medicinal products and medical devices, were retrospectively analyzed from May 2004 to the end of 2008 according to the number, research area, and type of opinion issued. Applications from 2008 were analyzed separately according to the study phase, participants (adult trials vs pediatric trials), and sponsor (commercial trials vs academic trials). Data were analyzed by descriptive statistics. Results Since its establishment in 2004, the Croatian Central Ethics Committee has reviewed 407 trials. The greatest number of clinical trials was in the field of oncology (n = 69), mental and behavioral disorders (n = 52), and endocrine, nutritional, and metabolic diseases (n = 50). In the initial assessment of clinical trials, 60% applications received a conditionally positive opinion. In 28% of applications, the opinion had to be postponed because additional documentation or explanations were required. In 2008, the Croatian Central Ethics Committee reviewed 99 trials, most of which were phase III trials (n = 57). Five clinical trials included pediatric population and 3 were academic clinical trials. Conclusion The model of centralized clinical trial review seems to be appropriate for the current number of clinical trials conducted in Croatia. The efficient and standardized review process of clinical trials by the Central Ethics Committee may positively affect the increasing number of clinical trials conducted in Croatia. Future development includes the transparency of the clinical trials through a publically available database and establishing the basis for conducting academic clinical trials. PMID:19399943

  19. Comparison of open and closed techniques of haemorrhoidectomy in terms of post-operative complications

    International Nuclear Information System (INIS)

    Majeed, S.; Qamar, S.R.; Tariq, M.; Ali, M.A.

    2015-01-01

    Haemorrhoids have been diagnosed and treated since the dawn of civilization, yet their cause, nature, symptomatology and especially their treatment options, remain hotly debated. The general principle however is that treatment should be directed by symptoms and the degree of haemorrhoids. The objective of the study is to compare early and late complications and wound healing time in open versus closed methods of haemorrhoidectomy. Methods: This was a Randomized control trial conducted at Department of Surgery CMH Kharian for a period of 3 years. During the period of study, patients presenting in Surgical OPD (Age Range 20-72 Years) with 3rd or 4th degree haemorrhoids requiring haemorrhoidectomy (n=364) were divided in two groups:- Group-1 was subjected to haemorrhoidectomy by open (Milligan-Morgan) technique and Group-2 underwent closed (Ferguson) haemorrhoidectomy. All patients were followed up for 2 months post-operatively and assessed for duration of wound healing and post-operative complications. Results: In group-1 (Open haemorrhoidectomy) patients ages ranged from 21-70 years with a mean age of 43 years (SD1±2.51). Duration of wound healing in this group was on the average 22 days (SD±5.76). Incidence of early post-operative complications including haemorrhage, infection and urinary retention was 4.94%, 8.24% and 7.14% respectively. The only late complication observed was anal stenosis in one patient (0.55%). No fissure or faecal incontinence was observed in this group. In group-2 (subjected to closed haemorrhoidectomy), patients ages ranged from 20-72 years with a mean age of 42 years (SD±10.31). Duration of wound healing was on the average 14 days (SD±3.25). Incidence of early post- operative complications, i.e., haemorrhage, infection and urinary retention was 2.19%, 7.69% and 2.75% respectively. No late complications (stenosis, fissure or incontinence) were observed in this group. Conclusion: There is no statistical significant difference between open

  20. US Navy Submarine Sea Trial of NASA developed Multi-Gas Monitor

    Science.gov (United States)

    Mudgett, Paul D.; Manney, Joshua A.; Smith, Matthew J.; O'Connor, Sara Jane; Pilgrim, Jeffrey S.

    2017-01-01

    During a successful 2 year technology demonstration of the tunable diode laser spectroscopy (TDLS) based Multi-Gas Monitor (MGM) on the International Space Station (ISS), we began discussing with the US Navy the possibility of conducting a sea trial of an MGM on a submarine. The sea trial would also include a gas chromatography/differential mobility spectrometer based Air Quality Monitor (AQM), which is used operationally on ISS for volatile organic compound analysis. AQM preparation and results will be the subject of a separate paper. The Navy's interest in testing NASA equipment in general relates to their ongoing search for better air monitoring technology. NASA's goal is studying submarines as closed environment analogs to spacecraft. MGM's core technology was developed by Vista Photonics Inc. using Small Business Innovation Research (SBIR) grants and expanded for various applications using NASA program funding. The MGM measures oxygen, carbon dioxide, ammonia and water vapor in ambient air, displays concentrations with temperature and pressure, and stores 30 second moving averages. The sea trial involves collocating the instrument with the Central Atmosphere Monitoring System (CAMS Mk II) of the submarine, connecting it to rack power prior to departure, and letting it run during the entire 90 day patrol. All data is stored within MGM, with no connection to the vessel data bus. Crew intervention is limited to checking MGM periodically to see that it is working and power cycling if necessary. After the trial is over, the unit with its data will be retrieved. Post sea trial calibration check and data analysis are planned and results will be compared with both CAMS Mk II data and results from MGM's ISS technology demonstration. Since the sea trial itself has been delayed, this paper describes the preparation of MGM for the sea trial and also provides a summary of the latest data from the ISS MGM technology demonstration.

  1. Placebo response rate in clinical trials of fistulizing Crohn's disease: systematic review and meta-analysis.

    Science.gov (United States)

    Ford, Alexander C; Luthra, Pavit; Hanauer, Stephen B; Travis, Simon P; Harris, M Scott; Reinisch, Walter

    2014-12-01

    It is important to determine the magnitude and identify modifiers of the rate of response to placebo in clinical trials of fistulizing Crohn's disease (CD), to understand disease progression, and to calculate sample size. We conducted a systematic review and meta-analysis of rates of response to placebo in trials of patients with fistulizing CD. We searched MEDLINE, EMBASE, EMBASE CLASSIC, and the Cochrane central register of controlled trials for randomized controlled trials (RCTs) comparing pharmacologic agents with placebo in adults with fistulizing CD. We identified studies that reported complete fistula closure, partial closure, or response. Data were extracted as intention-to-treat analyses and pooled by using a random-effects model. Proportions of patients who received placebo and had complete or partial fistula(e) closure were calculated, with 95% confidence intervals (CIs). The effects of trial characteristics on the magnitude of response to placebo were examined. Thirteen RCTs were eligible for our analysis; these included 579 patients assigned to placebo groups. The pooled rate of response to placebo, among all RCTs, for complete fistula closure was 15.6% (95% CI, 10.9%-20.9%), with significant heterogeneity (I(2) = 62.5%, P = .001). The pooled rate of response to placebo for partial fistula closure or response in 9 trials, comprising 423 patients, was 18.3% (95% CI, 14.8%-22.1%). Rates of response to placebo were significantly lower in trials with shorter durations of therapy and shorter intervals to assessment of fistula closure. Neither exposure to the pharmacologic agent during the induction phase of the same (or related) RCT nor concomitant medications had any effect. In a meta-analysis of rate of response to placebo in patients with fistulizing CD, we found that fistulae closed in almost 1/6 patients given placebo in RCTs of pharmacologic agents. Future research should identify characteristics of patients that predict response to placebo. Copyright

  2. Differentiating Closed Versus Open Spinal Dysraphisms on Fetal MRI.

    Science.gov (United States)

    Nagaraj, Usha D; Bierbrauer, Karin S; Peiro, Jose L; Kline-Fath, Beth M

    2016-12-01

    The purpose of this study is to identify differences in findings between open and closed spinal dysraphisms seen on fetal MR images. A single-institution retrospective analysis of fetal MR images for spinal dysraphism was performed. Postnatal images and clinical and operative reports were reviewed. Sixteen fetuses with postnatally confirmed closed spinal dysraphisms were included. Of these, 25% (4/16) had posterior fossa anomalies, 12.5% (2/16) had ventriculomegaly, and 37.5% (6/16) had OEIS (omphalocele, exstrophy, imperforate anus, and spinal defects) complex. Of 90 fetuses with postnatally confirmed open spinal dysraphism, 95.6% (86/90) had posterior fossa anomalies, 85.6% (77/90) had ventriculomegaly, and none had OEIS complex. Twenty fetuses with open spinal dysraphism were randomly selected to compare with fetuses with closed spinal dysraphisms. Continuity of the epidermal and subcutaneous tissues with the sac wall on fetal MR images was seen in 93.8% (15/16) of patients with closed spinal dysraphisms, as opposed to 5% (1/20) of patients with open spinal dysraphisms. The mean (± SD) sac wall thickness was less in open (0.7 ± 0.6 mm) than closed (2.9 ± 1.3 mm; p OEIS complex.

  3. Clinical Trials

    Medline Plus

    Full Text Available ... include factors such as a patient's age and gender, the type and stage of disease, and whether ... successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, ...

  4. Clinical Trials

    Medline Plus

    Full Text Available ... principles or strategies include studies that explore whether surgery or other medical treatments produce better results for ... and approved it? What kinds of tests, medicines, surgery, or devices are involved? Are any procedures painful? ...

  5. Data monitoring committees for pragmatic clinical trials.

    Science.gov (United States)

    Ellenberg, Susan S; Culbertson, Richard; Gillen, Daniel L; Goodman, Steven; Schrandt, Suzanne; Zirkle, Maryan

    2015-10-01

    In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the interests of research participants and ensuring trial integrity in many trials. Many pragmatic clinical trials, which aim to inform healthcare decisions by comparing alternate interventions in heterogeneous healthcare delivery settings, will warrant review by an independent data monitoring committee due to their potential impact on clinical practice. However, the very features that make a trial "pragmatic" may pose challenges in terms of which aspects of a trial to monitor and when it is appropriate for a data monitoring committee to intervene. Using the Pragmatic-Explanatory Continuum Indicator Summary tool that draws distinctions between pragmatic and explanatory clinical trials, we review characteristics of pragmatic clinical trials that may have implications for data monitoring committees and interim monitoring plans. These include broad eligibility criteria, a focus on subjective patient-centered outcomes, and in some cases a lack of standardized follow-up procedures across study sites. Additionally, protocol adherence is often purposefully not addressed in pragmatic trials in order to accurately represent the clinical practice setting and maintain practicability of implementation; there are differing viewpoints as to whether adherence should be assessed and acted upon by data monitoring committees in these trials. Some other issues not specifically related to the Pragmatic-Explanatory Continuum Indicator Summary criteria may also merit special consideration in pragmatic trials. Thresholds for early termination of a pragmatic clinical trial might be controversial. The distinguishing features of pragmatic clinical

  6. 75 FR 7370 - Closed Captioning of Video Programming; Closed Captioning Requirements for Digital Television...

    Science.gov (United States)

    2010-02-19

    ... FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 79 [CG Docket No. 05-231; ET Docket No. 99-254; FCC 08-255] Closed Captioning of Video Programming; Closed Captioning Requirements for Digital Television... Captioning of Video Programming; Closed Captioning Requirements for Digital Television Receivers, Declaratory...

  7. Static, Lightweight Includes Resolution for PHP

    NARCIS (Netherlands)

    M.A. Hills (Mark); P. Klint (Paul); J.J. Vinju (Jurgen)

    2014-01-01

    htmlabstractDynamic languages include a number of features that are challenging to model properly in static analysis tools. In PHP, one of these features is the include expression, where an arbitrary expression provides the path of the file to include at runtime. In this paper we present two

  8. Article Including Environmental Barrier Coating System

    Science.gov (United States)

    Lee, Kang N. (Inventor)

    2015-01-01

    An enhanced environmental barrier coating for a silicon containing substrate. The enhanced barrier coating may include a bond coat doped with at least one of an alkali metal oxide and an alkali earth metal oxide. The enhanced barrier coating may include a composite mullite bond coat including BSAS and another distinct second phase oxide applied over said surface.

  9. Rare thoracic cancers, including peritoneum mesothelioma

    NARCIS (Netherlands)

    Siesling, Sabine; van der Zwan, Jan Maarten; Izarzugaza, Isabel; Jaal, Jana; Treasure, Tom; Foschi, Roberto; Ricardi, Umberto; Groen, Harry; Tavilla, Andrea; Ardanaz, Eva

    Rare thoracic cancers include those of the trachea, thymus and mesothelioma (including peritoneum mesothelioma). The aim of this study was to describe the incidence, prevalence and survival of rare thoracic tumours using a large database, which includes cancer patients diagnosed from 1978 to 2002,

  10. Rare thoracic cancers, including peritoneum mesothelioma

    NARCIS (Netherlands)

    Siesling, Sabine; Zwan, J.M.V.D.; Izarzugaza, I.; Jaal, J.; Treasure, T.; Foschi, R.; Ricardi, U.; Groen, H.; Tavilla, A.; Ardanaz, E.

    2012-01-01

    Rare thoracic cancers include those of the trachea, thymus and mesothelioma (including peritoneum mesothelioma). The aim of this study was to describe the incidence, prevalence and survival of rare thoracic tumours using a large database, which includes cancer patients diagnosed from 1978 to 2002,

  11. A cluster-randomised trial of a multifaceted quality improvement intervention in Brazilian intensive care units (Checklist-ICU trial): statistical analysis plan.

    Science.gov (United States)

    Damiani, Lucas P; Cavalcanti, Alexandre B; Moreira, Frederico R; Machado, Flavia; Bozza, Fernando A; Salluh, Jorge I F; Campagnucci, Valquiria P; Normilio-Silva, Karina; Chiattone, Viviane C; Angus, Derek C; Berwanger, Otavio; Chou H Chang, Chung-

    2015-06-01

    The Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units (Checklist- ICU) trial is a pragmatic, two-arm, cluster-randomised trial involving 118 intensive care units in Brazil, with the primary objective of determining if a multifaceted qualityimprovement intervention with a daily checklist, definition of daily care goals during multidisciplinary daily rounds and clinician prompts can reduce inhospital mortality. To describe our trial statistical analysis plan (SAP). This is an ongoing trial conducted in two phases. In the preparatory observational phase, we collect three sets of baseline data: ICU characteristics; patient characteristics, processes of care and outcomes; and completed safety attitudes questionnaires (SAQs). In the randomised phase, ICUs are assigned to the experimental or control arms and we collect patient data and repeat the SAQ. Our SAP includes the prespecified model for the primary and secondary outcome analyses, which account for the cluster-randomised design and availability of baseline data. We also detail the multiple mediation models that we will use to assess our secondary hypothesis (that the effect of the intervention on inhospital mortality is mediated not only through care processes targeted by the checklist, but also through changes in safety culture). We describe our approach to sensitivity and subgroup analyses and missing data. We report our SAP before closing our study database and starting analysis. We anticipate that this should prevent analysis bias and enhance the utility of results.

  12. HIV Model Parameter Estimates from Interruption Trial Data including Drug Efficacy and Reservoir Dynamics

    Science.gov (United States)

    Luo, Rutao; Piovoso, Michael J.; Martinez-Picado, Javier; Zurakowski, Ryan

    2012-01-01

    Mathematical models based on ordinary differential equations (ODE) have had significant impact on understanding HIV disease dynamics and optimizing patient treatment. A model that characterizes the essential disease dynamics can be used for prediction only if the model parameters are identifiable from clinical data. Most previous parameter identification studies for HIV have used sparsely sampled data from the decay phase following the introduction of therapy. In this paper, model parameters are identified from frequently sampled viral-load data taken from ten patients enrolled in the previously published AutoVac HAART interruption study, providing between 69 and 114 viral load measurements from 3–5 phases of viral decay and rebound for each patient. This dataset is considerably larger than those used in previously published parameter estimation studies. Furthermore, the measurements come from two separate experimental conditions, which allows for the direct estimation of drug efficacy and reservoir contribution rates, two parameters that cannot be identified from decay-phase data alone. A Markov-Chain Monte-Carlo method is used to estimate the model parameter values, with initial estimates obtained using nonlinear least-squares methods. The posterior distributions of the parameter estimates are reported and compared for all patients. PMID:22815727

  13. Development of a fast closing valve system

    International Nuclear Information System (INIS)

    Nakajima, K.; Wakabayashi, K.; Hayashi, S.

    1984-01-01

    A fast closing valve is connected to a beam line branched from an electron storage ring. It protects the ultra-high-vacuum (UHV) system against inrushes of air, which may accidentally occur at a measuring station located at the down stream of the beam flow. Tow types of fast closing valve systems have been developed. The closing time guaranteed is 50 ms and 10 sm respectively for the nearly same aperture size of 150 x 15 mm. The 10 ms FCV system is described. The leak rate characteristics are kept within about 0.1 Torr.lit/sec. (1.33 x 10 -2 Pa m 3 /sec.), even after closing operations of 1000 times. (author)

  14. 76 FR 57767 - Post Office Closing

    Science.gov (United States)

    2011-09-16

    ... determination to close the Ionia post office in Ionia, Missouri. The petition was filed by William Smart, Mayor... the interest of expedition, in light of the 120-day decision schedule, the Commission may request the...

  15. A Historical Look at Close Air Support

    National Research Council Canada - National Science Library

    Hasken, Scott

    2003-01-01

    .... There are periods where close coordination and cooperation led to extremely effective CAS. Experiences in North Africa during World War II proved to be a harbinger of CAS throughout the twentieth century...

  16. A theory of desynchronisable closed loop system

    Directory of Open Access Journals (Sweden)

    Harsh Beohar

    2010-10-01

    Full Text Available The task of implementing a supervisory controller is non-trivial, even though different theories exist that allow automatic synthesis of these controllers in the form of automata. One of the reasons for this discord is due to the asynchronous interaction between a plant and its controller in implementations, whereas the existing supervisory control theories assume synchronous interaction. As a consequence the implementation suffer from the so-called inexact synchronisation problem. In this paper we address the issue of inexact synchronisation in a process algebraic setting, by solving a more general problem of refinement. We construct an asynchronous closed loop system by introducing a communication medium in a given synchronous closed loop system. Our goal is to find sufficient conditions under which a synchronous closed loop system is branching bisimilar to its corresponding asynchronous closed loop system.

  17. 50 CFR 665.251 - Closed areas.

    Science.gov (United States)

    2010-10-01

    ..., DEPARTMENT OF COMMERCE (CONTINUED) FISHERIES IN THE WESTERN PACIFIC Hawaii Fisheries § 665.251 Closed areas. All lobster fishing is prohibited: (a) Within 20 nm of Laysan Island. (b) Within the EEZ landward of...

  18. Single particle closed orbits in Yukawa potential

    Science.gov (United States)

    Mukherjee, R.; Sounda, S.

    2018-02-01

    Orbit of a single particle moving under the Yukawa potential is studied and there exists precessing ellipse type orbits. The amount of precession can be tuned through the coupling parameter α. With a suitable choice of the coupling parameter; we get a closed bound orbit. In some cases few petals are observed which is possessed of a closed bound nature for suitably chosen coupling parameter. Threshold energy has also been calculated for bound orbits.

  19. Mining Frequent Max and Closed Sequential Patterns

    OpenAIRE

    Afshar, Ramin

    2002-01-01

    Although frequent sequential pattern mining has an important role in many data mining tasks, however, it often generates a large number of sequential patterns, which reduces its efficiency and effectiveness. For many applications mining all the frequent sequential patterns is not necessary, and mining frequent Max, or Closed sequential patterns will provide the same amount of information. Comparing to frequent sequential pattern mining, frequent Max, or Closed sequential pattern mining g...

  20. Laser welding closed-loop power control

    DEFF Research Database (Denmark)

    Bagger, Claus; Olsen, Flemming Ove

    2003-01-01

    A closed-loop control system is developed to maintain an even seam width on the root side of a laser weld by continually controlling the output laser power of a 1500 W CO2 laser.......A closed-loop control system is developed to maintain an even seam width on the root side of a laser weld by continually controlling the output laser power of a 1500 W CO2 laser....