WorldWideScience

Sample records for madit-crt proposed post-approval

  1. Effect of Metoprolol Versus Carvedilol on Outcomes in MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy)

    DEFF Research Database (Denmark)

    Ruwald, Martin H; Ruwald, Anne-Christine H; Jøns, Christian

    2013-01-01

    This study sought to compare the effects of metoprolol and carvedilol in the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) study.......This study sought to compare the effects of metoprolol and carvedilol in the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) study....

  2. Cardiac Resynchronization in Different Age Groups: A MADIT-CRT Long-Term Follow-Up Substudy.

    Science.gov (United States)

    Thomas, Sabu; Moss, Arthur J; Zareba, Wojciech; McNitt, Scott; Barsheshet, Alon; Klein, Helmut; Goldenberg, Ilan; Huang, David T; Biton, Yitschak; Kutyifa, Valentina

    2016-02-01

    Cardiac resynchronization with defibrillators (CRT-D) reduces heart failure and mortality compared with defibrillators alone. Whether this applies to all ages is unclear. We assessed the association of age on heart failure and death as a post hoc analysis of the MADIT-CRT follow-up study, in which 1,281 patients with class I/II heart failure (HF) were randomized to CRT-D or implantable cardioverter-defibrillators alone. Different age groups (age groups, there were 399, 651, and 231 patients, respectively. We compared events with the use of a multivariate regression model. CRT-D compared with defibrillators alone significantly reduced the composite of HF or death across all age groups: age groups: age group: RRR = 59%. CRT-D reduced HF events and the composite of mortality or HF events during long-term follow-up in all age groups. CRT-D reduced mortality only in the 60-74 year age group. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Novel ICD Programming and Inappropriate ICD Therapy in CRT-D Versus ICD Patients: A MADIT-RIT Sub-Study.

    Science.gov (United States)

    Kutyifa, Valentina; Daubert, James P; Schuger, Claudio; Goldenberg, Ilan; Klein, Helmut; Aktas, Mehmet K; McNitt, Scott; Stockburger, Martin; Merkely, Bela; Zareba, Wojciech; Moss, Arthur J

    2016-01-01

    The Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate therapy (MADIT-RIT) trial showed a significant reduction in inappropriate implantable cardioverter defibrillator (ICD) therapy in patients programmed to high-rate cut-off (Arm B) or delayed ventricular tachycardia therapy (Arm C), compared with conventional programming (Arm A). There is limited data on the effect of cardiac resynchronization therapy with a cardioverter defibrillator (CRT-D) on the effect of ICD programming. We aimed to elucidate the effect of CRT-D on ICD programming to reduce inappropriate ICD therapy in patients implanted with CRT-D or an ICD, enrolled in MADIT-RIT. The primary end point of this study was the first inappropriate ICD therapy. Secondary end points were inappropriate anti-tachycardia pacing and inappropriate ICD shock. The study enrolled 742 (49%) patients with an ICD and 757 (51%) patients with a CRT-D. Patients implanted with a CRT-D had 62% lower risk of inappropriate ICD therapy than those with an ICD only (hazard ratio [HR] =0.38, 95% confidence interval: 0.25-0.57; Pprogramming significantly reduced the risk of inappropriate ICD therapy compared with conventional ICD programming in ICD (HR=0.14 [B versus A]; HR=0.21 [C versus A]) and CRT-D patients (HR=0.15 [B versus A]; HR=0.23 [C versus A]; Pprogramming significantly reduces the risk of inappropriate ICD therapy in both ICD and CRT-D patients. http://clinicaltrials.gov; Unique identifier: NCT00947310. © 2016 American Heart Association, Inc.

  4. Heart failure severity, inappropriate ICD therapy, and novel ICD programming: a MADIT-RIT substudy.

    Science.gov (United States)

    Daimee, Usama A; Vermilye, Katherine; Rosero, Spencer; Schuger, Claudio D; Daubert, James P; Zareba, Wojciech; McNitt, Scott; Polonsky, Bronislava; Moss, Arthur J; Kutyifa, Valentina

    2017-12-01

    The effects of heart failure (HF) severity on risk of inappropriate implantable cardioverter-defibrillator (ICD) therapy have not been thoroughly investigated. We aimed to study the association between HF severity and inappropriate ICD therapy in MADIT-RIT. MADIT-RIT randomized 1,500 patients to three ICD programming arms: conventional (Arm A), high-rate cut-off (Arm B: ≥200 beats/min), and delayed therapy (Arm C: 60-second delay for ≥170 beats/min). We evaluated the association between New York Heart Association (NYHA) class III (n = 256) versus class I-II (n = 251) and inappropriate ICD therapy in Arm A patients with ICD-only and cardiac resynchronization therapy with defibrillator (CRT-D). We additionally assessed benefit of novel ICD programming in Arms B and C versus Arm A by NYHA classification. In Arm A, the risk of inappropriate therapy was significantly higher in those with NYHA III versus NYHA I-II for both ICD (hazard ratio [HR] = 2.55, confidence interval [CI]: 1.51-4.30, P programming significantly reduced inappropriate therapy in patients with both NYHA III (Arm B vs Arm A: HR = 0.08, P programming with high-rate cut-off or delayed detection reduces inappropriate ICD therapies in both mild and moderate HF. © 2017 Wiley Periodicals, Inc.

  5. Hybrid cryptosystem RSA - CRT optimization and VMPC

    Science.gov (United States)

    Rahmadani, R.; Mawengkang, H.; Sutarman

    2018-03-01

    Hybrid cryptosystem combines symmetric algorithms and asymmetric algorithms. This combination utilizes speeds on encryption/decryption processes of symmetric algorithms and asymmetric algorithms to secure symmetric keys. In this paper we propose hybrid cryptosystem that combine symmetric algorithms VMPC and asymmetric algorithms RSA - CRT optimization. RSA - CRT optimization speeds up the decryption process by obtaining plaintext with dp and p key only, so there is no need to perform CRT processes. The VMPC algorithm is more efficient in software implementation and reduces known weaknesses in RC4 key generation. The results show hybrid cryptosystem RSA - CRT optimization and VMPC is faster than hybrid cryptosystem RSA - VMPC and hybrid cryptosystem RSA - CRT - VMPC. Keyword : Cryptography, RSA, RSA - CRT, VMPC, Hybrid Cryptosystem.

  6. The effect of ICD programming on inappropriate and appropriate ICD Therapies in ischemic and nonischemic cardiomyopathy: the MADIT-RIT trial.

    Science.gov (United States)

    Sedláček, Kamil; Ruwald, Anne-Christine; Kutyifa, Valentina; McNitt, Scott; Thomsen, Poul Erik Bloch; Klein, Helmut; Stockburger, Martin; Wichterle, Dan; Merkely, Bela; DE LA Concha, Joaquin Fernandez; Swissa, Moshe; Zareba, Wojciech; Moss, Arthur J; Kautzner, Josef; Ruwald, Martin H

    2015-04-01

    The MADIT-RIT trial demonstrated reduction of inappropriate and appropriate ICD therapies and mortality by high-rate cut-off and 60-second-delayed VT therapy ICD programming in patients with a primary prophylactic ICD indication. The aim of this analysis was to study effects of MADIT-RIT ICD programming in patients with ischemic and nonischemic cardiomyopathy. First and total occurrences of both inappropriate and appropriate ICD therapies were analyzed by multivariate Cox models in 791 (53%) patients with ischemic and 707 (47%) patients with nonischemic cardiomyopathy. Patients with ischemic and nonischemic cardiomyopathy had similar incidence of first inappropriate (9% and 11%, P = 0.21) and first appropriate ICD therapy (11.6% and 14.1%, P = 0.15). Patients with ischemic cardiomyopathy had higher mortality rate (6.1% vs. 3.3%, P = 0.01). MADIT-RIT high-rate cut-off (arm B) and delayed VT therapy ICD programming (arm C) compared with conventional (arm A) ICD programming were associated with a significant risk reduction of first inappropriate and appropriate ICD therapy in patients with ischemic and nonischemic cardiomyopathy (HR range 0.11-0.34, P programming and delayed VT therapy ICD programming in both ischemic and nonischemic cardiomyopathy patients. High-rate cut-off and delayed VT therapy ICD programming are associated with significant reduction in first and total inappropriate and appropriate ICD therapy in patients with ischemic and nonischemic cardiomyopathy. © 2014 Wiley Periodicals, Inc.

  7. Impact of carvedilol and metoprolol on inappropriate implantable cardioverter-defibrillator therapy

    DEFF Research Database (Denmark)

    Ruwald, Martin H; Abu-Zeitone, Abeer; Jons, Christian

    2013-01-01

    The goal of this study was to evaluate the effects of carvedilol and metoprolol on the endpoint of inappropriate implantable cardioverter-defibrillator therapy in the MADIT-CRT (Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy) study....

  8. Strain analysis in CRT candidates using the novel segment length in cine (SLICE) post-processing technique on standard CMR cine images.

    Science.gov (United States)

    Zweerink, Alwin; Allaart, Cornelis P; Kuijer, Joost P A; Wu, LiNa; Beek, Aernout M; van de Ven, Peter M; Meine, Mathias; Croisille, Pierre; Clarysse, Patrick; van Rossum, Albert C; Nijveldt, Robin

    2017-12-01

    Although myocardial strain analysis is a potential tool to improve patient selection for cardiac resynchronization therapy (CRT), there is currently no validated clinical approach to derive segmental strains. We evaluated the novel segment length in cine (SLICE) technique to derive segmental strains from standard cardiovascular MR (CMR) cine images in CRT candidates. Twenty-seven patients with left bundle branch block underwent CMR examination including cine imaging and myocardial tagging (CMR-TAG). SLICE was performed by measuring segment length between anatomical landmarks throughout all phases on short-axis cines. This measure of frame-to-frame segment length change was compared to CMR-TAG circumferential strain measurements. Subsequently, conventional markers of CRT response were calculated. Segmental strains showed good to excellent agreement between SLICE and CMR-TAG (septum strain, intraclass correlation coefficient (ICC) 0.76; lateral wall strain, ICC 0.66). Conventional markers of CRT response also showed close agreement between both methods (ICC 0.61-0.78). Reproducibility of SLICE was excellent for intra-observer testing (all ICC ≥0.76) and good for interobserver testing (all ICC ≥0.61). The novel SLICE post-processing technique on standard CMR cine images offers both accurate and robust segmental strain measures compared to the 'gold standard' CMR-TAG technique, and has the advantage of being widely available. • Myocardial strain analysis could potentially improve patient selection for CRT. • Currently a well validated clinical approach to derive segmental strains is lacking. • The novel SLICE technique derives segmental strains from standard CMR cine images. • SLICE-derived strain markers of CRT response showed close agreement with CMR-TAG. • Future studies will focus on the prognostic value of SLICE in CRT candidates.

  9. 13 CFR 302.18 - Post-approval requirements.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Post-approval requirements. 302.18 Section 302.18 Business Credit and Assistance ECONOMIC DEVELOPMENT ADMINISTRATION, DEPARTMENT OF COMMERCE... Federal cost principles (collectively, “Post-Approval Requirements”). A Recipient's failure to comply with...

  10. 30 CFR 14.10 - Post-approval product audit.

    Science.gov (United States)

    2010-07-01

    ..., AND APPROVAL OF MINING PRODUCTS REQUIREMENTS FOR THE APPROVAL OF FLAME-RESISTANT CONVEYOR BELTS General Provisions § 14.10 Post-approval product audit. (a) Approved conveyor belts will be subject to... based. MSHA will select an approved conveyor belt to be audited; the selected belt will be...

  11. Strain analysis in CRT candidates using the novel segment length in cine (SLICE) post-processing technique on standard CMR cine images

    Energy Technology Data Exchange (ETDEWEB)

    Zweerink, Alwin; Allaart, Cornelis P.; Wu, LiNa; Beek, Aernout M.; Rossum, Albert C. van; Nijveldt, Robin [VU University Medical Center, Department of Cardiology, and Institute for Cardiovascular Research (ICaR-VU), Amsterdam (Netherlands); Kuijer, Joost P.A. [VU University Medical Center, Department of Physics and Medical Technology, Amsterdam (Netherlands); Ven, Peter M. van de [VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam (Netherlands); Meine, Mathias [University Medical Center, Department of Cardiology, Utrecht (Netherlands); Croisille, Pierre; Clarysse, Patrick [Univ Lyon, UJM-Saint-Etienne, INSA, CNRS UMR 5520, INSERM U1206, CREATIS, Saint-Etienne (France)

    2017-12-15

    Although myocardial strain analysis is a potential tool to improve patient selection for cardiac resynchronization therapy (CRT), there is currently no validated clinical approach to derive segmental strains. We evaluated the novel segment length in cine (SLICE) technique to derive segmental strains from standard cardiovascular MR (CMR) cine images in CRT candidates. Twenty-seven patients with left bundle branch block underwent CMR examination including cine imaging and myocardial tagging (CMR-TAG). SLICE was performed by measuring segment length between anatomical landmarks throughout all phases on short-axis cines. This measure of frame-to-frame segment length change was compared to CMR-TAG circumferential strain measurements. Subsequently, conventional markers of CRT response were calculated. Segmental strains showed good to excellent agreement between SLICE and CMR-TAG (septum strain, intraclass correlation coefficient (ICC) 0.76; lateral wall strain, ICC 0.66). Conventional markers of CRT response also showed close agreement between both methods (ICC 0.61-0.78). Reproducibility of SLICE was excellent for intra-observer testing (all ICC ≥0.76) and good for interobserver testing (all ICC ≥0.61). The novel SLICE post-processing technique on standard CMR cine images offers both accurate and robust segmental strain measures compared to the 'gold standard' CMR-TAG technique, and has the advantage of being widely available. (orig.)

  12. Strain analysis in CRT candidates using the novel segment length in cine (SLICE) post-processing technique on standard CMR cine images

    International Nuclear Information System (INIS)

    Zweerink, Alwin; Allaart, Cornelis P.; Wu, LiNa; Beek, Aernout M.; Rossum, Albert C. van; Nijveldt, Robin; Kuijer, Joost P.A.; Ven, Peter M. van de; Meine, Mathias; Croisille, Pierre; Clarysse, Patrick

    2017-01-01

    Although myocardial strain analysis is a potential tool to improve patient selection for cardiac resynchronization therapy (CRT), there is currently no validated clinical approach to derive segmental strains. We evaluated the novel segment length in cine (SLICE) technique to derive segmental strains from standard cardiovascular MR (CMR) cine images in CRT candidates. Twenty-seven patients with left bundle branch block underwent CMR examination including cine imaging and myocardial tagging (CMR-TAG). SLICE was performed by measuring segment length between anatomical landmarks throughout all phases on short-axis cines. This measure of frame-to-frame segment length change was compared to CMR-TAG circumferential strain measurements. Subsequently, conventional markers of CRT response were calculated. Segmental strains showed good to excellent agreement between SLICE and CMR-TAG (septum strain, intraclass correlation coefficient (ICC) 0.76; lateral wall strain, ICC 0.66). Conventional markers of CRT response also showed close agreement between both methods (ICC 0.61-0.78). Reproducibility of SLICE was excellent for intra-observer testing (all ICC ≥0.76) and good for interobserver testing (all ICC ≥0.61). The novel SLICE post-processing technique on standard CMR cine images offers both accurate and robust segmental strain measures compared to the 'gold standard' CMR-TAG technique, and has the advantage of being widely available. (orig.)

  13. Screening and risk evaluation for sudden cardiac death in ischaemic and non-ischaemic cardiomyopathy

    DEFF Research Database (Denmark)

    Proclemer, Alessandro; Lewalter, Thorsten; Bongiorni, Maria Grazia

    2013-01-01

    The purpose of this EHRA survey was to examine the current clinical practice of screening and risk evaluation for sudden cardiac death in ischaemic and non-ischaemic cardiomyopathy with a focus on selection of candidates for implantable cardioverter-defibrillator (ICD) therapy, timing of ICD...... implantation, and use of non-invasive and invasive diagnostic tests across Europe. A systematic screening programme for sudden cardiac death existed in 19 out of 31 centres (61.3%). Implantation of ICDs according to the inclusion criteria of MADIT-II and SCD-HeFT trials was reported in 30 and 29% of centres......, respectively, followed by MADIT-CRT (18%), COMPANION (16%), and combined MADIT and MUSTT (7%) indications. In patients with severe renal impairment, ICD implantation for primary prevention of sudden death was always avoided in 8 centres (33.3%), was not used only if creatinine level was >2.5 mg/dL in 10...

  14. Chemical Reactivity Test (CRT)

    Energy Technology Data Exchange (ETDEWEB)

    Zaka, F. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States)

    2016-12-13

    The Chemical Reactivity Test (CRT) is used to determine the thermal stability of High Explosives (HEs) and chemical compatibility between (HEs) and alien materials. The CRT is one of the small-scale safety tests performed on HE at the High Explosives Applications Facility (HEAF).

  15. Development of a highly reliable CRT processor

    International Nuclear Information System (INIS)

    Shimizu, Tomoya; Saiki, Akira; Hirai, Kenji; Jota, Masayoshi; Fujii, Mikiya

    1996-01-01

    Although CRT processors have been employed by the main control board to reduce the operator's workload during monitoring, the control systems are still operated by hardware switches. For further advancement, direct controller operation through a display device is expected. A CRT processor providing direct controller operation must be as reliable as the hardware switches are. The authors are developing a new type of highly reliable CRT processor that enables direct controller operations. In this paper, we discuss the design principles behind a highly reliable CRT processor. The principles are defined by studies of software reliability and of the functional reliability of the monitoring and operation systems. The functional configuration of an advanced CRT processor is also addressed. (author)

  16. 30 CFR 71.301 - Respirable dust control plan; approval by District Manager and posting.

    Science.gov (United States)

    2010-07-01

    ... District Manager and posting. 71.301 Section 71.301 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... plan; approval by District Manager and posting. (a) The District Manager will approve respirable dust control plans on a mine-by-mine basis. When approving respirable dust control plans, the District Manager...

  17. Foaming of CRT panel glass powder using Na2CO3

    DEFF Research Database (Denmark)

    Petersen, Rasmus Rosenlund; König, Jakob; Smedskjær, Morten Mattrup

    2014-01-01

    The recycling of glass from obsolete cathode ray tubes (CRT) has hitherto only occurred to a very limited extent, but the production of foam glass used as an insulation material component has recently been proposed as a promising recycling method. CRT panel glass has high recycling potential due...... to its non-hazardous composition. Here we report on the foaming of CRT panel glass using Na2CO3 as the foaming agent. We explore how heat treatment temperature and concentration of Na2CO3 affect the density and porosity of the foam glasses, and whether Na2O is incorporated in the glass network....... The optimum foaming temperature for minimising density and maximising closed porosity is found to be between 1023 and 1123 K. The pore structure depends on the amount of added Na2CO3, viz, the pores generally become more open with increasing Na2CO3 content. A minimum density of 0·28 g/cm3 is found when 14 wt...

  18. Choice reaction time in patients with post-operative cognitive dysfunction

    DEFF Research Database (Denmark)

    Steinmetz, J.; Rasmussen, L.S.

    2008-01-01

    BACKGROUND: Post-operative cognitive dysfunction (POCD) is detected by administration of a neuropsychological test battery. Reaction time testing is at present not included as a standard test. Choice reaction time (CRT) data from the first International Study of Post-operative Cognitive Dysfunction...... in nine countries. CRT was measured 52 times using the four boxes test. Patients performed the test before surgery (n=1083), at 1 week (n=926) and at 3 months (n=852) post-operatively. CRT for the individual patient was determined as the median time of correct responses. The usefulness of the CRT...... had a significantly longer CRT. ROC curves revealed that a reaction time of 813 ms was the most appropriate cut-off at 1 week and 762 ms at 3 months but the positive predictive value for POCD was low: 34.4% and 14.7%, respectively. CONCLUSIONS: Post-operative cognitive dysfunction is associated...

  19. 78 FR 69168 - Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed...

    Science.gov (United States)

    2013-11-18

    ... approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70848; File No. SR-NSCC-2013-10] Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed Rule Change To...

  20. 77 FR 74722 - Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Order Approving Proposed Rule...

    Science.gov (United States)

    2012-12-17

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68401; File No. SR-CME-2012-42] Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Order Approving Proposed Rule Change Regarding the Valuation of... to approve a proposed rule change of a self-regulatory organization if it finds that such proposed...

  1. 77 FR 40394 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

    Science.gov (United States)

    2012-07-09

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67333; File No. SR-OCC-2012-07] Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Adjustment... to approve a proposed rule change of a self-regulatory organization if it finds that such proposed...

  2. Derrick Bell, CRT, and Educational Leadership 1995-Present

    Science.gov (United States)

    Khalifa, Muhammad; Dunbar, Christopher; Douglasb, Ty-Ron

    2013-01-01

    Critical Race Theory (CRT) has become a centered conceptual framework to understand American education and reform (Ladson-Billings and Tate 1995; Solorzano and Yosso; 2001; Decuir and Dixon 2004). Indeed, educational leadership scholars have not been far behind in recognizing the explicative and powerful role of CRT studies in their work (Lopez…

  3. Direction of CRT waste glass processing: Electronics recycling industry communication

    International Nuclear Information System (INIS)

    Mueller, Julia R.; Boehm, Michael W.; Drummond, Charles

    2012-01-01

    Highlights: ► Given a large flow rate of CRT glass ∼10% of the panel glass stream will be leaded. ► The supply of CRT waste glass exceeded demand in 2009. ► Recyclers should use UV-light to detect lead oxide during the separation process. ► Recycling market analysis techniques and results are given for CRT glass. ► Academic initiatives and the necessary expansion of novel product markets are discussed. - Abstract: Cathode Ray Tube, CRT, waste glass recycling has plagued glass manufacturers, electronics recyclers and electronics waste policy makers for decades because the total supply of waste glass exceeds demand, and the formulations of CRT glass are ill suited for most reuse options. The solutions are to separate the undesirable components (e.g. lead oxide) in the waste and create demand for new products. Achieving this is no simple feat, however, as there are many obstacles: limited knowledge of waste glass composition; limited automation in the recycling process; transportation of recycled material; and a weak and underdeveloped market. Thus one of the main goals of this paper is to advise electronic glass recyclers on how to best manage a diverse supply of glass waste and successfully market to end users. Further, this paper offers future directions for academic and industry research. To develop the recommendations offered here, a combination of approaches were used: (1) a thorough study of historic trends in CRT glass chemistry; (2) bulk glass collection and analysis of cullet from a large-scale glass recycler; (3) conversations with industry members and a review of potential applications; and (4) evaluation of the economic viability of specific uses for recycled CRT glass. If academia and industry can solve these problems (for example by creating a database of composition organized by manufacturer and glass source) then the reuse of CRT glass can be increased.

  4. 13 CFR 307.6 - Economic Adjustment Assistance post-approval requirements.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Economic Adjustment Assistance post-approval requirements. 307.6 Section 307.6 Business Credit and Assistance ECONOMIC DEVELOPMENT... § 302.18 of this chapter: (a) Strategy Grants shall comply with the applicable provisions of part 303 of...

  5. Cognitive remediation therapy (CRT) in a specialist inpatient eating disorder service for children and adolescents: CAN-CRT study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Giombini, Lucia; Nesbitt, Sophie; Cox, Hannah; Foxall, Anna; Sharia, Teo; Easter, Abigail; Tchanturia, Kate

    2018-03-26

    Research on treatments for young people (YP) with anorexia nervosa (AN) is scarce. Evidence supports the use of cognitive remediation therapy (CRT) to improve central coherence and set-shifting, inefficiencies that can negatively impact on prognosis. The study aims to evaluate the feasibility of individual CRT in an inpatient setting for YP aged 10-18 years with AN and to qualitatively examine YP's and their parents experiences. In a single-centre, pilot, randomised controlled trial, 80 patients aged 10-18 years with AN will be randomly allocated to the immediate or delayed CRT group, in addition to standard treatment. A repeated measures design will be conducted across 3 time points. The data will provide evidence regarding the feasibility of individual CRT in YP with AN, informing directions of further development of CRT. The study is in preparation for a definitive randomised controlled trial. The aim of this manuscript is to describe the study protocol. Copyright © 2018 John Wiley & Sons, Ltd and Eating Disorders Association.

  6. Proposed Changes to EPA's Transuranic Waste Characterization Approval Process

    International Nuclear Information System (INIS)

    Joglekar, R.D.; Feltcorn, E.M.; Ortiz, A.M.

    2003-01-01

    This paper describes the changes to the waste characterization (WC) approval process proposed in August 2002 by the U.S. Environmental Protection Agency (EPA or the Agency or we). EPA regulates the disposal of transuranic (TRU) waste at the Waste Isolation Pilot Plant (WIPP) repository in Carlsbad, New Mexico. EPA regulations require that waste generator/storage sites seek EPA approval of WC processes used to characterize TRU waste destined for disposal at WIPP. The regulations also require that EPA verify, through site inspections, characterization of each waste stream or group of waste streams proposed for disposal at the WIPP. As part of verification, the Agency inspects equipment, procedures, and interviews personnel to determine if the processes used by a site can adequately characterize the waste in order to meet the waste acceptance criteria for WIPP. The paper discusses EPA's mandate, current regulations, inspection experience, and proposed changes. We expect that th e proposed changes will provide equivalent or improved oversight. Also, they would give EPA greater flexibility in scheduling and conducting inspections, and should clarify the regulatory process of inspections for both Department of Energy (DOE) and the public

  7. 78 FR 28267 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

    Science.gov (United States)

    2013-05-14

    ... Trust Company (``DTC'') and maintain accounts to facilitate Delivery Orders (``DOs'') to approved... Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed... securities transactions and foster cooperation and coordination with persons engaged in the clearance and...

  8. Development and optimization of SPECT gated blood pool cluster analysis for the prediction of CRT outcome

    Energy Technology Data Exchange (ETDEWEB)

    Lalonde, Michel, E-mail: mlalonde15@rogers.com; Wassenaar, Richard [Department of Physics, Carleton University, Ottawa, Ontario K1S 5B6 (Canada); Wells, R. Glenn; Birnie, David; Ruddy, Terrence D. [Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario K1Y 4W7 (Canada)

    2014-07-15

    Purpose: Phase analysis of single photon emission computed tomography (SPECT) radionuclide angiography (RNA) has been investigated for its potential to predict the outcome of cardiac resynchronization therapy (CRT). However, phase analysis may be limited in its potential at predicting CRT outcome as valuable information may be lost by assuming that time-activity curves (TAC) follow a simple sinusoidal shape. A new method, cluster analysis, is proposed which directly evaluates the TACs and may lead to a better understanding of dyssynchrony patterns and CRT outcome. Cluster analysis algorithms were developed and optimized to maximize their ability to predict CRT response. Methods: About 49 patients (N = 27 ischemic etiology) received a SPECT RNA scan as well as positron emission tomography (PET) perfusion and viability scans prior to undergoing CRT. A semiautomated algorithm sampled the left ventricle wall to produce 568 TACs from SPECT RNA data. The TACs were then subjected to two different cluster analysis techniques, K-means, and normal average, where several input metrics were also varied to determine the optimal settings for the prediction of CRT outcome. Each TAC was assigned to a cluster group based on the comparison criteria and global and segmental cluster size and scores were used as measures of dyssynchrony and used to predict response to CRT. A repeated random twofold cross-validation technique was used to train and validate the cluster algorithm. Receiver operating characteristic (ROC) analysis was used to calculate the area under the curve (AUC) and compare results to those obtained for SPECT RNA phase analysis and PET scar size analysis methods. Results: Using the normal average cluster analysis approach, the septal wall produced statistically significant results for predicting CRT results in the ischemic population (ROC AUC = 0.73;p < 0.05 vs. equal chance ROC AUC = 0.50) with an optimal operating point of 71% sensitivity and 60% specificity. Cluster

  9. Development and optimization of SPECT gated blood pool cluster analysis for the prediction of CRT outcome

    International Nuclear Information System (INIS)

    Lalonde, Michel; Wassenaar, Richard; Wells, R. Glenn; Birnie, David; Ruddy, Terrence D.

    2014-01-01

    Purpose: Phase analysis of single photon emission computed tomography (SPECT) radionuclide angiography (RNA) has been investigated for its potential to predict the outcome of cardiac resynchronization therapy (CRT). However, phase analysis may be limited in its potential at predicting CRT outcome as valuable information may be lost by assuming that time-activity curves (TAC) follow a simple sinusoidal shape. A new method, cluster analysis, is proposed which directly evaluates the TACs and may lead to a better understanding of dyssynchrony patterns and CRT outcome. Cluster analysis algorithms were developed and optimized to maximize their ability to predict CRT response. Methods: About 49 patients (N = 27 ischemic etiology) received a SPECT RNA scan as well as positron emission tomography (PET) perfusion and viability scans prior to undergoing CRT. A semiautomated algorithm sampled the left ventricle wall to produce 568 TACs from SPECT RNA data. The TACs were then subjected to two different cluster analysis techniques, K-means, and normal average, where several input metrics were also varied to determine the optimal settings for the prediction of CRT outcome. Each TAC was assigned to a cluster group based on the comparison criteria and global and segmental cluster size and scores were used as measures of dyssynchrony and used to predict response to CRT. A repeated random twofold cross-validation technique was used to train and validate the cluster algorithm. Receiver operating characteristic (ROC) analysis was used to calculate the area under the curve (AUC) and compare results to those obtained for SPECT RNA phase analysis and PET scar size analysis methods. Results: Using the normal average cluster analysis approach, the septal wall produced statistically significant results for predicting CRT results in the ischemic population (ROC AUC = 0.73;p < 0.05 vs. equal chance ROC AUC = 0.50) with an optimal operating point of 71% sensitivity and 60% specificity. Cluster

  10. 77 FR 74225 - Proposed Extension of the Approval of Information Collection Requirements

    Science.gov (United States)

    2012-12-13

    ... proposal to extend Office of Management and Budget (OMB) approval of the Information Collection: Work-Study... reporting requirements that include a Work Study Program application and written participation agreement. In... private school system to file with the Wage and Hour Division Administrator an application for approval of...

  11. The human factors of CRT displays for nuclear power plant control

    International Nuclear Information System (INIS)

    Danchak, M.M.

    1984-01-01

    This chapter attempts to show how the Cathode Ray Tube (CRT) can be used to effectively present information to the operator rather than just data. The capabilities of the human as a sensing and information processing subsystem are discussed with CRT displays in mind. The display system is described in terms of its hardware and functioning. The interface between the two is examined by providing substantive guidelines for the effective design of CRT displays for nuclear power plant control. Alphanumeric displays, graphic displays, and representational displays are treated. The design of CRT displays for nuclear power plant control requires an extensive knowledge of cognitive psychology, computer display systems and the process being controlled

  12. Overexpression of a Triticum aestivum Calreticulin gene (TaCRT1 Improves Salinity Tolerance in Tobacco.

    Directory of Open Access Journals (Sweden)

    Yang Xiang

    Full Text Available Calreticulin (CRT is a highly conserved and abundant multifunctional protein that is encoded by a small gene family and is often associated with abiotic/biotic stress responses in plants. However, the roles played by this protein in salt stress responses in wheat (Triticum aestivum remain obscure. In this study, three TaCRT genes were identified in wheat and named TaCRT1, TaCRT2 and TaCRT3-1 based on their sequence characteristics and their high homology to other known CRT genes. Quantitative real-time PCR expression data revealed that these three genes exhibit different expression patterns in different tissues and are strongly induced under salt stress in wheat. The calcium-binding properties of the purified recombinant TaCRT1 protein were determined using a PIPES/Arsenazo III analysis. TaCRT1 gene overexpression in Nicotiana tabacum decreased salt stress damage in transgenic tobacco plants. Physiological measurements indicated that transgenic tobacco plants showed higher activities of superoxide dismutase (SOD, peroxidase (POD and catalase (CAT than non-transgenic tobacco under normal growth conditions. Interestingly, overexpression of the entire TaCRT1 gene or of partial TaCRT1 segments resulted in significantly higher tolerance to salt stress in transgenic plants compared with their WT counterparts, thus revealing the essential role of the C-domain of TaCRT1 in countering salt stress in plants.

  13. Quantification and probabilistic modeling of CRT obsolescence for the State of Delaware

    International Nuclear Information System (INIS)

    Schumacher, Kelsea A.; Schumacher, Thomas; Agbemabiese, Lawrence

    2014-01-01

    Highlights: • We modeled the obsolescence of cathode ray tube devices in the State of Delaware. • 411,654 CRT units or ∼16,500 metric tons have been recycled in Delaware since 2002. • The peak of the CRT obsolescence in Delaware passed by 2012. • The Delaware average CRT recycling rate between 2002 and 13 was approximately 27.5%. • CRTs will continue to infiltrate the system likely until 2033. - Abstract: The cessation of production and replacement of cathode ray tube (CRT) displays with flat screen displays have resulted in the proliferation of CRTs in the electronic waste (e-waste) recycle stream. However, due to the nature of the technology and presence of hazardous components such as lead, CRTs are the most challenging of electronic components to recycle. In the State of Delaware it is due to this challenge and the resulting expense combined with the large quantities of CRTs in the recycle stream that electronic recyclers now charge to accept Delaware’s e-waste. Therefore it is imperative that the Delaware Solid Waste Authority (DSWA) understand future quantities of CRTs entering the waste stream. This study presents the results of an assessment of CRT obsolescence in the State of Delaware. A prediction model was created utilizing publicized sales data, a variety of lifespan data as well as historic Delaware CRT collection rates. Both a deterministic and a probabilistic approach using Monte Carlo Simulation (MCS) were performed to forecast rates of CRT obsolescence to be anticipated in the State of Delaware. Results indicate that the peak of CRT obsolescence in Delaware has already passed, although CRTs are anticipated to enter the waste stream likely until 2033

  14. Clinical application analysis of 3D-CRT methods using tomography

    Energy Technology Data Exchange (ETDEWEB)

    Cho, Kang Chul; Kyum, Hun Kyum; Kim, Joo Ho; Ahn, Seung Kwon; Lee, Sang Kyoo; Yoon, Jong Won; Cho, Jeong Hee [Dept. of Radiation Oncology, Yonsei Cancer Center, Yonsei University Health System, Seoul (Korea, Republic of); Lee, Jong Seok; Yoo, Beong Gyu [Dept. of Radiotechnology, Wonkwang Health Science University, Iksan (Korea, Republic of)

    2013-12-15

    This study investigates the case of clinical application for TomoDirect 3D-CRT(TD-3D) and TomoHelical 3D-CRT(TH-3D) with evaluating dose distribution for clinical application in each case. Treatment plans were created for 8 patients who had 3 dimensional conformal radiation therapy using TD-3D and TH-3D mode. Each patients were treated for sarcoma, CSI(craniospinal irradiation), breast, brain, pancreas, spine metastasis, SVC syndrome and esophagus. DVH(dose volume histogram) and isodose curve were used for comparison of each treatment modality. TD-3D shows better dose distribution over the irradiation field without junction effect because TD-3D was not influenced by target length for sarcoma and CSI case. In breast case, dosimetric results of CTV, the average value of D 99%, D 95% were 49.2±0.4 Gy, 49.9±0.4 Gy and V 105%, V 110% were 0%, respectively. TH-3D with the dosimetric block decreased dose of normal organ in brain, pancreas, spine metastasis case. SCV syndrome also effectively decreased dose of normal organ by using dose block to the critical organs(spinal cord <38 Gy). TH-3D combined with other treatment modalities was possible to boost irradiation and was total dose was reduced to spinal cord in esophagus case(spinal cord <45 Gy, lung V 20 <20%). 3D-CRT using Tomotherapy could overcomes some dosimetric limitations, when we faced Conventional Linac based CRT and shows clinically proper dose distribution. In conclusion, 3D-CRT using Tomotherapy will be one of the effective 3D-CRT techniques.

  15. 77 FR 15336 - Revision to the Export Provisions of the Cathode Ray Tube (CRT) Rule

    Science.gov (United States)

    2012-03-15

    ... exporters of CRTs for recycling must submit an annual report to EPA. The purpose of these proposed revisions... reuse and recycling. Additionally, EPA would gather more information on shipments of CRTs that are sent... who export used cathode ray tubes (CRTs) and CRT glass for reuse or recycling. This action does not...

  16. A Nematode Calreticulin, Rs-CRT, Is a Key Effector in Reproduction and Pathogenicity of Radopholus similis.

    Science.gov (United States)

    Li, Yu; Wang, Ke; Xie, Hui; Wang, Yan-Tao; Wang, Dong-Wei; Xu, Chun-Lin; Huang, Xin; Wang, De-Sen

    2015-01-01

    Radopholus similis is a migratory plant-parasitic nematode that causes severe damage to many agricultural and horticultural crops. Calreticulin (CRT) is a Ca2+-binding multifunctional protein that plays key roles in the parasitism, immune evasion, reproduction and pathogenesis of many animal parasites and plant nematodes. Therefore, CRT is a promising target for controlling R. similis. In this study, we obtained the full-length sequence of the CRT gene from R. similis (Rs-crt), which is 1,527-bp long and includes a 1,206-bp ORF that encodes 401 amino acids. Rs-CRT and Mi-CRT from Meloidogyne incognita showed the highest similarity and were grouped on the same branch of the phylogenetic tree. Rs-crt is a multi-copy gene that is expressed in the oesophageal glands and gonads of females, the gonads of males, the intestines of juveniles and the eggs of R. similis. The highest Rs-crt expression was detected in females, followed by juveniles, eggs and males. The reproductive capability and pathogenicity of R. similis were significantly reduced after treatment with Rs-crt dsRNA for 36 h. Using plant-mediated RNAi, we confirmed that Rs-crt expression was significantly inhibited in the nematodes, and resistance to R. similis was significantly improved in transgenic tomato plants. Plant-mediated RNAi-induced silencing of Rs-crt could be effectively transmitted to the F2 generation of R. similis; however, the silencing effect of Rs-crt induced by in vitro RNAi was no longer detectable in F1 and F2 nematodes. Thus, Rs-crt is essential for the reproduction and pathogenicity of R. similis.

  17. A Nematode Calreticulin, Rs-CRT, Is a Key Effector in Reproduction and Pathogenicity of Radopholus similis.

    Directory of Open Access Journals (Sweden)

    Yu Li

    Full Text Available Radopholus similis is a migratory plant-parasitic nematode that causes severe damage to many agricultural and horticultural crops. Calreticulin (CRT is a Ca2+-binding multifunctional protein that plays key roles in the parasitism, immune evasion, reproduction and pathogenesis of many animal parasites and plant nematodes. Therefore, CRT is a promising target for controlling R. similis. In this study, we obtained the full-length sequence of the CRT gene from R. similis (Rs-crt, which is 1,527-bp long and includes a 1,206-bp ORF that encodes 401 amino acids. Rs-CRT and Mi-CRT from Meloidogyne incognita showed the highest similarity and were grouped on the same branch of the phylogenetic tree. Rs-crt is a multi-copy gene that is expressed in the oesophageal glands and gonads of females, the gonads of males, the intestines of juveniles and the eggs of R. similis. The highest Rs-crt expression was detected in females, followed by juveniles, eggs and males. The reproductive capability and pathogenicity of R. similis were significantly reduced after treatment with Rs-crt dsRNA for 36 h. Using plant-mediated RNAi, we confirmed that Rs-crt expression was significantly inhibited in the nematodes, and resistance to R. similis was significantly improved in transgenic tomato plants. Plant-mediated RNAi-induced silencing of Rs-crt could be effectively transmitted to the F2 generation of R. similis; however, the silencing effect of Rs-crt induced by in vitro RNAi was no longer detectable in F1 and F2 nematodes. Thus, Rs-crt is essential for the reproduction and pathogenicity of R. similis.

  18. 75 FR 36444 - Proposed Extension of the Approval of Information Collection Requirements

    Science.gov (United States)

    2010-06-25

    ... be provided in the desired format, reporting burden (time and financial resources) is minimized... DEPARTMENT OF LABOR Wage and Hour Division Proposed Extension of the Approval of Information... comment on proposed and/or continuing collections of information in accordance with the Paperwork...

  19. 76 FR 48181 - Proposed Extension of the Approval of Information Collection Requirements

    Science.gov (United States)

    2011-08-08

    ... be provided in a desired format, reporting burden (time and financial resources) is minimized... DEPARTMENT OF LABOR Wage and Hour Division Proposed Extension of the Approval of Information... comment on proposed and/or continuing collections of information in accordance with the Paperwork...

  20. 76 FR 15348 - Proposed Extension of the Approval of Information Collection Requirements

    Science.gov (United States)

    2011-03-21

    ... be provided in the desired format, reporting burden (time and financial resources) is minimized... DEPARTMENT OF LABOR Wage and Hour Division Proposed Extension of the Approval of Information... comment on proposed and/or continuing collections of information in accordance with the Paperwork...

  1. A comparison of salvage surgery following CRT and following BRT for advanced hypopharyngeal cancer

    International Nuclear Information System (INIS)

    Kamijo, Tomoyuki; Onitsuka, Tetsuro; Yokota, Tomoya

    2016-01-01

    There are still few comparison reports regarding the safety of salvage surgery for recurrence and persistence following platinum-based chemoradiotherapy (CRT) and cetuximab-based bioradiotherapy (BRT), which are frequently used as non-surgical therapies for advanced head and neck carcinomas. This study compared the safety of salvage surgery following CRT against that following BRT for advanced hypopharyngeal cancer. The study examined 34 cases who underwent salvage surgery following CRT and 7 cases who underwent salvage surgery following BRT from September 2002 to December 2015. The number of cases that were able to undergo salvage surgery was 34 among 67 recurrence and persistence cases following CRT and 7 of 8 cases following BRT. In terms of the surgical procedure, salvage neck dissection was conducted for 22 cases in the CRT group and 5 cases in the BRT group, with no significant differences observed between both including the surgical time and amount of bleeding, and with no major complications in either group. Total hypopharynx or total laryngectomy resection for salvage was conducted for 19 cases in the CRT group and 3 cases in the BRT group, upon which we observed anastomotic leakage in 3 cases in the CRT group and 1 case in the BRT group; however, there was no significant difference in the onset frequency. There was no clear difference regarding safety between salvage surgery following CRT and following BRT for locally advanced hypopharyngeal cancer. However, regarding the adaptation of salvage surgery, the possibility of limitations in the CRT group was suggested in comparison with the BRT group. (author)

  2. Direction of CRT waste glass processing: electronics recycling industry communication.

    Science.gov (United States)

    Mueller, Julia R; Boehm, Michael W; Drummond, Charles

    2012-08-01

    Cathode Ray Tube, CRT, waste glass recycling has plagued glass manufacturers, electronics recyclers and electronics waste policy makers for decades because the total supply of waste glass exceeds demand, and the formulations of CRT glass are ill suited for most reuse options. The solutions are to separate the undesirable components (e.g. lead oxide) in the waste and create demand for new products. Achieving this is no simple feat, however, as there are many obstacles: limited knowledge of waste glass composition; limited automation in the recycling process; transportation of recycled material; and a weak and underdeveloped market. Thus one of the main goals of this paper is to advise electronic glass recyclers on how to best manage a diverse supply of glass waste and successfully market to end users. Further, this paper offers future directions for academic and industry research. To develop the recommendations offered here, a combination of approaches were used: (1) a thorough study of historic trends in CRT glass chemistry; (2) bulk glass collection and analysis of cullet from a large-scale glass recycler; (3) conversations with industry members and a review of potential applications; and (4) evaluation of the economic viability of specific uses for recycled CRT glass. If academia and industry can solve these problems (for example by creating a database of composition organized by manufacturer and glass source) then the reuse of CRT glass can be increased. Copyright © 2012 Elsevier Ltd. All rights reserved.

  3. The Cosmic Ray Tracking (CRT) detector system

    International Nuclear Information System (INIS)

    Bernloehr, K.; Gamp, S.; Hermann, G.; Hofmann, W.; Kihm, T.; Knoeppler, J.; Leffers, G.; Matheis, V.; Panter, M.; Trunk, U.; Ulrich, M.; Wolf, T.; Zink, R.; Heintze, J.

    1996-01-01

    The Cosmic Ray Tracking (CRT) project represents a study on the use of tracking detectors of the time projection chamber type to detect secondary cosmic ray particles in extensive air showers. In reconstructing the arrival direction of the primary cosmic ray particles, the CRT detectors take advantage of the angular correlation of secondary particles with the cosmic rays leading to these air showers. In this paper, the detector hardware including the custom-designed electronics system is described in detail. A CRT detector module provides an active area of 2.5 m 2 and allows to measure track directions with a precision of 0.4 circle . It consists of two circular drift chambers of 1.8 m diameter with six sense wires each, and a 10 cm thick iron plate between the two chambers. Each detector has a local electronics box with a readout, trigger, and monitoring system. The detectors can distinguish penetrating muons from other types of charged secondaries. A large detector array could be used to search for γ-ray point sources at energies above several TeV and for studies of the cosmic-ray composition. Ten detectors are in operation at the site of the HEGRA air shower array. (orig.)

  4. Comparison of observer performance reading from a video CRT vs. reading from film

    International Nuclear Information System (INIS)

    Keyes, J.W. Jr.; Kline, R.C.; Resinger, W.W.; Rose, E.A.; Koral, K.F.; Rogers, W.L.

    1983-01-01

    The developing trend for all medical images to be in digital form raises an important question: should diagnostic interpretations be made directly from a CRT or from some form of hard copy recording of the CRT. This question was studied by having two observers read a series of digital images of the thyroid including both conventional scintigrams and computer-generated tomograms. The CRT images were photographed in a carefully controlled fashion. Images were read once from film and a second time directly from the CRT. No significant difference in performance could be found for either display modality based on an ROC analysis. Although based on uncomplicated images and analysis, this result suggests that the decision to read from film or from the CRT can be made on other grounds than observer performance. This important result needs confirmation with more complex images such as ultrasound or CT

  5. Implementasi Kriptografi Kunci Publik dengan Algoritma RSA-CRT pada Aplikasi Instant Messaging

    Directory of Open Access Journals (Sweden)

    Ashari Arief

    2016-06-01

    Full Text Available Instant messaging merupakan salah satu bentuk kemajuan teknologi komunikasi yang mempermudah penyampaian informasi. Saat ini, dengan semakin banyaknya pengguna aplikasi instant messaging berakibat pada dampak negatif berupa penyadapan data khususnya saat terjadi komunikasi yang bersifat rahasia. Algoritma RSA merupakan salah satu satu algoritma dalam kriptografi kunci publik. Pada proses enkripsi dan dekripsi digunakan kunci yang berbeda. Proses dekripsi algoritma RSA sering terjadi kendala karena ukuran kunci dekripsi yang relatif besar dapat memperlambat proses. Untuk mempercepat proses dekripsi, algoritma RSA dapat dimodifikasi dengan algoritma CRT (Chinese Remainder Theorem, sering disebut dengan Algoritma RSA-CRT. Implementasi algoritma kriptografi RSA-CRT pada aplikasi instant messaging pada panjang bit n mulai dari 56 bit sampai 88 bit, proses dekripsi RSA-CRT dua kali lebih cepat dibandingkan proses dekripsi RSA. 

  6. Plasmodium falciparum chloroquine resistance transporter (PfCRT) isoforms PH1 and PH2 perturb vacuolar physiology.

    Science.gov (United States)

    Callaghan, Paul S; Siriwardana, Amila; Hassett, Matthew R; Roepe, Paul D

    2016-03-31

    Recent work has perfected yeast-based methods for measuring drug transport by the Plasmodium falciparum chloroquine (CQ) resistance transporter (PfCRT). The approach relies on inducible heterologous expression of PfCRT in Saccharomyces cerevisiae yeast. In these experiments selecting drug concentrations are not toxic to the yeast, nor is expression of PfCRT alone toxic. Only when PfCRT is expressed in the presence of CQ is the growth of yeast impaired, due to inward transport of chloroquine (CQ) via the transporter. During analysis of all 53 known naturally occurring PfCRT isoforms, two isoforms (PH1 and PH2 PfCRT) were found to be intrinsically toxic to yeast, even in the absence of CQ. Additional analysis of six very recently identified PfCRT isoforms from Malaysia also showed some toxicity. In this paper the nature of this yeast toxicity is examined. Data also show that PH1 and PH2 isoforms of PfCRT transport CQ with an efficiency intermediate to that catalyzed by previously studied CQR conferring isoforms. Mutation of PfCRT at position 160 is found to perturb vacuolar physiology, suggesting a fitness cost to position 160 amino acid substitutions. These data further define the wide range of activities that exist for PfCRT isoforms found in P. falciparum isolates from around the globe.

  7. Partner approval and intention to use contraception among Zanzibari women presenting for post-abortion care.

    Science.gov (United States)

    Esber, Allahna; Foraker, Randi E; Hemed, Maryam; Norris, Alison

    2014-07-01

    We examined the effect of partner approval of contraception on intention to use contraception among women obtaining post-abortion care in Zanzibar. Our data source was a 2010 survey of 193 women obtaining post-abortion care at a large public hospital in Zanzibar. We used multivariable logistic regression analysis to assess associations between partner approval and intention to use contraception. Overall, 23% of participants had used a contraceptive method in the past, and 66% reported intending to use contraception in the future. We found that partner approval of contraception and ever having used contraception in the past were each associated with intending to use contraception in the future. In the multivariable model, adjusting for past contraception use, partner approval of contraception was associated with 20 times the odds of intending to use contraception (odds ratio, 20.25; 95% confidence interval, 8.45-48.56). We found a strong association between partner approval and intention to use contraception. Efforts to support contraceptive use must include both male and female partners. Public health and educational efforts to increase contraceptive use must include men and be targeted to both male and female partners. Given that male partners are often not present when women obtain health care, creative efforts will be required to meet men in community settings. Copyright © 2014 Elsevier Inc. All rights reserved.

  8. A wheat calreticulin gene (TaCRT1) contributes to drought tolerance in transgenic arabidopsis

    International Nuclear Information System (INIS)

    Xiang, V.; Du, C.; Jia, H.; Song, M.; Wang, Y.; Ma, Z.

    2018-01-01

    The TaCRT1 gene is a member of calreticulin (CRT) family in wheat. In our previous study, we showed that transgenic tobacco lines over expressing wheat TaCRT1 showed enhanced tolerance to salt stress. This study aimed to determine whether TaCRT1 over expression would increase drought tolerance in transgenic Arabidopsis. Over expression of TaCRT1 in Arabidopsis plants enhances tolerance to drought stress. However, the transgenic line was found to retard the growth. Moreover, the transgenic line showed decreased water loss but higher sensitivity to exogenous abscisic acid (ABA) compared with the wild type (Col-0). Meanwhile, the transgenic line had the elevated endogenous ABA level. The semi-quantitative RT-PCR (sqRT-PCR) analysis showed that transcription levels of ABA-biosynthesizing gene (NCED3) and ABA-responsive gene (ABF3) were higher in the transgenic line than that in the Col-0 under normal condition. The above results implied that the TaCRT1 might be able to used as a potential target to improve the drought tolerance in crops. (author)

  9. Strain analysis in CRT candidates using the novel segment length in cine (SLICE) post-processing technique on standard CMR cine images

    NARCIS (Netherlands)

    Zweerink, A.; Allaart, C.P.; Kuijer, J.P.A.; Wu, L.; Beek, A.M.; Ven, P.M. van de; Meine, M.; Croisille, P.; Clarysse, P.; Rossum, A.C. van; Nijveldt, R.

    2017-01-01

    OBJECTIVES: Although myocardial strain analysis is a potential tool to improve patient selection for cardiac resynchronization therapy (CRT), there is currently no validated clinical approach to derive segmental strains. We evaluated the novel segment length in cine (SLICE) technique to derive

  10. Colorimetry for CRT displays.

    Science.gov (United States)

    Golz, Jürgen; MacLeod, Donald I A

    2003-05-01

    We analyze the sources of error in specifying color in CRT displays. These include errors inherent in the use of the color matching functions of the CIE 1931 standard observer when only colorimetric, not radiometric, calibrations are available. We provide transformation coefficients that prove to correct the deficiencies of this observer very well. We consider four different candidate sets of cone sensitivities. Some of these differ substantially; variation among candidate cone sensitivities exceeds the variation among phosphors. Finally, the effects of the recognized forms of observer variation on the visual responses (cone excitations or cone contrasts) generated by CRT stimuli are investigated and quantitatively specified. Cone pigment polymorphism gives rise to variation of a few per cent in relative excitation by the different phosphors--a variation larger than the errors ensuing from the adoption of the CIE standard observer, though smaller than the differences between some candidate cone sensitivities. Macular pigmentation has a larger influence, affecting mainly responses to the blue phosphor. The estimated combined effect of all sources of observer variation is comparable in magnitude with the largest differences between competing cone sensitivity estimates but is not enough to disrupt very seriously the relation between the L and M cone weights and the isoluminance settings of individual observers. It is also comparable with typical instrumental colorimetric errors, but we discuss these only briefly.

  11. Iron is a substrate of the Plasmodium falciparum chloroquine resistance transporter PfCRT in Xenopus oocytes.

    Science.gov (United States)

    Bakouh, Naziha; Bellanca, Sebastiano; Nyboer, Britta; Moliner Cubel, Sonia; Karim, Zoubida; Sanchez, Cecilia P; Stein, Wilfred D; Planelles, Gabrielle; Lanzer, Michael

    2017-09-29

    The chloroquine resistance transporter of the human malaria parasite Plasmodium falciparum , PfCRT, is an important determinant of resistance to several quinoline and quinoline-like antimalarial drugs. PfCRT also plays an essential role in the physiology of the parasite during development inside erythrocytes. However, the function of this transporter besides its role in drug resistance is still unclear. Using electrophysiological and flux experiments conducted on PfCRT-expressing Xenopus laevis oocytes, we show here that both wild-type PfCRT and a PfCRT variant associated with chloroquine resistance transport both ferrous and ferric iron, albeit with different kinetics. In particular, we found that the ability to transport ferrous iron is reduced by the specific polymorphisms acquired by the PfCRT variant as a result of chloroquine selection. We further show that iron and chloroquine transport via PfCRT is electrogenic. If these findings in the Xenopus model extend to P. falciparum in vivo , our data suggest that PfCRT might play a role in iron homeostasis, which is essential for the parasite's development in erythrocytes. © 2017 by The American Society for Biochemistry and Molecular Biology, Inc.

  12. Cardiac resynchronization therapy (CRT). From the fundamentals to the successful implantation

    International Nuclear Information System (INIS)

    Butter, C.; Minden, H.H.

    2008-01-01

    The cardiac resynchronization therapy (CRT) has been developed during the past years toward an established method for chronic severe heart insufficiencies. The book is an overview of the fundamentals of CRT and a practical guideline for a successful implantation. Based on x-ray imaging using coloured structures every required step of the implantation is demonstrated [de

  13. [Financial impact of introducing filmless CRT diagnosis].

    Science.gov (United States)

    Kusakabe, Yukihiro

    2002-09-01

    There has been a great deal of discussion as to the cost and benefit of introducing filmless CRT diagnosis for radiological exams. Although the various advantages of the filmless system tend to be highlighted, very few studies have attempted to provide a quantitative estimate of the degree of impact. We analyzed the potential financial impact on the cost of film management (film development, maintenance, and transportation) if CRT diagnosis were to be introduced in Seirei Hamamatsu Hospital. In conducting this analysis, we assumed that CRT diagnosis initially would be limited to CT and MR. The analysis demonstrated that the actual yearly cost of managing films amounts to about 240 million yen. As individual items, the cost of film materials, labor, and depreciation of assets were the three largest cost sectors, with the cost of film accounting for more than 30% of the total. The expense attributable to CT and MR exams was roughly half of the total cost. Against this level of expense, the expected savings in the first year after shifting to the filmless system would be 100 million yen, or a 36% reduction in current expenses. This savings reflects various effects of system change, including lack of need for related materials, reduction in staff workload, elimination of unnecessary equipment, etc. Under the simulation we conducted, 70% of savings occurred in the area of variable costs and 30% in the area of fixed costs.

  14. A novel construction method of QC-LDPC codes based on CRT for optical communications

    Science.gov (United States)

    Yuan, Jian-guo; Liang, Meng-qi; Wang, Yong; Lin, Jin-zhao; Pang, Yu

    2016-05-01

    A novel construction method of quasi-cyclic low-density parity-check (QC-LDPC) codes is proposed based on Chinese remainder theory (CRT). The method can not only increase the code length without reducing the girth, but also greatly enhance the code rate, so it is easy to construct a high-rate code. The simulation results show that at the bit error rate ( BER) of 10-7, the net coding gain ( NCG) of the regular QC-LDPC(4 851, 4 546) code is respectively 2.06 dB, 1.36 dB, 0.53 dB and 0.31 dB more than those of the classic RS(255, 239) code in ITU-T G.975, the LDPC(32 640, 30 592) code in ITU-T G.975.1, the QC-LDPC(3 664, 3 436) code constructed by the improved combining construction method based on CRT and the irregular QC-LDPC(3 843, 3 603) code constructed by the construction method based on the Galois field ( GF( q)) multiplicative group. Furthermore, all these five codes have the same code rate of 0.937. Therefore, the regular QC-LDPC(4 851, 4 546) code constructed by the proposed construction method has excellent error-correction performance, and can be more suitable for optical transmission systems.

  15. Plasmodium falciparum chloroquine resistance transporter (PfCRT) isoforms PH1 and PH2 perturb vacuolar physiology

    OpenAIRE

    Callaghan, Paul S.; Siriwardana, Amila; Hassett, Matthew R.; Roepe, Paul D.

    2016-01-01

    Background Recent work has perfected yeast-based methods for measuring drug transport by the Plasmodium falciparum chloroquine (CQ) resistance transporter (PfCRT). Methods The approach relies on inducible heterologous expression of PfCRT in Saccharomyces cerevisiae yeast. In these experiments selecting drug concentrations are not toxic to the yeast, nor is expression of PfCRT alone toxic. Only when PfCRT is expressed in the presence of CQ is the growth of yeast impaired, due to inward transpo...

  16. Enrichment of provitamin A content in wheat (Triticum aestivum L.) by introduction of the bacterial carotenoid biosynthetic genes CrtB and CrtI.

    Science.gov (United States)

    Wang, Cheng; Zeng, Jian; Li, Yin; Hu, Wei; Chen, Ling; Miao, Yingjie; Deng, Pengyi; Yuan, Cuihong; Ma, Cheng; Chen, Xi; Zang, Mingli; Wang, Qiong; Li, Kexiu; Chang, Junli; Wang, Yuesheng; Yang, Guangxiao; He, Guangyuan

    2014-06-01

    Carotenoid content is a primary determinant of wheat nutritional value and affects its end-use quality. Wheat grains contain very low carotenoid levels and trace amounts of provitamin A content. In order to enrich the carotenoid content in wheat grains, the bacterial phytoene synthase gene (CrtB) and carotene desaturase gene (CrtI) were transformed into the common wheat cultivar Bobwhite. Expression of CrtB or CrtI alone slightly increased the carotenoid content in the grains of transgenic wheat, while co-expression of both genes resulted in a darker red/yellow grain phenotype, accompanied by a total carotenoid content increase of approximately 8-fold achieving 4.76 μg g(-1) of seed dry weight, a β-carotene increase of 65-fold to 3.21 μg g(-1) of seed dry weight, and a provitamin A content (sum of α-carotene, β-carotene, and β-cryptoxanthin) increase of 76-fold to 3.82 μg g(-1) of seed dry weight. The high provitamin A content in the transgenic wheat was stably inherited over four generations. Quantitative PCR analysis revealed that enhancement of provitamin A content in transgenic wheat was also a result of the highly coordinated regulation of endogenous carotenoid biosynthetic genes, suggesting a metabolic feedback regulation in the wheat carotenoid biosynthetic pathway. These transgenic wheat lines are not only valuable for breeding wheat varieties with nutritional benefits for human health but also for understanding the mechanism regulating carotenoid biosynthesis in wheat endosperm. © The Author 2014. Published by Oxford University Press on behalf of the Society for Experimental Biology.

  17. Human factors engineering review for CRT screen design

    International Nuclear Information System (INIS)

    Yi, S. M.; Joo, C. Y.; Ra, J. C.

    1999-01-01

    The information interface between man and machine may be more important than hardware and workplace layout considerations. Transmitting and receiving data through this information interface can be characterized as a communication or interface problem. Management of man-machine interface is essential for the enhancement of the information processing and decision-making capability of computer users working in real time, demanding task. The design of human-computer interface is not a rigid and static procedure. The content and context of each interface varies according to the specific application. So, the purpose of this study is to review the human factor design process for interfaces, to make human factor guidelines for CRT screen and to apply these to CRT screen design. (author)

  18. Functional Analysis and Marker Development of TaCRT-D Gene in Common Wheat (Triticum aestivum L.

    Directory of Open Access Journals (Sweden)

    Jiping Wang

    2017-09-01

    Full Text Available Calreticulin (CRT, an endoplasmic reticulum (ER-localized Ca2+-binding/buffering protein, is highly conserved and extensively expressed in animal and plant cells. To understand the function of CRTs in wheat (Triticum aestivum L., particularly their roles in stress tolerance, we cloned the full-length genomic sequence of the TaCRT-D isoform from D genome of common hexaploid wheat, and characterized its function by transgenic Arabidopsis system. TaCRT-D exhibited different expression patterns in wheat seedling under different abiotic stresses. Transgenic Arabidopsis plants overexpressing ORF of TaCRT-D displayed more tolerance to drought, cold, salt, mannitol, and other abiotic stresses at both seed germination and seedling stages, compared with the wild-type controls. Furthermore, DNA polymorphism analysis and gene mapping were employed to develop the functional markers of this gene for marker-assistant selection in wheat breeding program. One SNP, S440 (T→C was detected at the TaCRT-D locus by genotyping a wheat recombinant inbred line (RIL population (114 lines developed from Opata 85 × W7984. The TaCRT-D was then fine mapped between markers Xgwm645 and Xgwm664 on chromosome 3DL, corresponding to genetic distances of 3.5 and 4.4 cM, respectively, using the RIL population and Chinese Spring nulli-tetrasomic lines. Finally, the genome-specific and allele-specific markers were developed for the TaCRT-D gene. These findings indicate that TaCRT-D function importantly in plant stress responses, providing a gene target for genetic engineering to increase plant stress tolerance and the functional markers of TaCRT-D for marker-assistant selection in wheat breeding.

  19. Functional Analysis and Marker Development of TaCRT-D Gene in Common Wheat (Triticum aestivum L.).

    Science.gov (United States)

    Wang, Jiping; Li, Runzhi; Mao, Xinguo; Jing, Ruilian

    2017-01-01

    Calreticulin (CRT), an endoplasmic reticulum (ER)-localized Ca 2+ -binding/buffering protein, is highly conserved and extensively expressed in animal and plant cells. To understand the function of CRTs in wheat ( Triticum aestivum L.), particularly their roles in stress tolerance, we cloned the full-length genomic sequence of the TaCRT-D isoform from D genome of common hexaploid wheat, and characterized its function by transgenic Arabidopsis system. TaCRT-D exhibited different expression patterns in wheat seedling under different abiotic stresses. Transgenic Arabidopsis plants overexpressing ORF of TaCRT-D displayed more tolerance to drought, cold, salt, mannitol, and other abiotic stresses at both seed germination and seedling stages, compared with the wild-type controls. Furthermore, DNA polymorphism analysis and gene mapping were employed to develop the functional markers of this gene for marker-assistant selection in wheat breeding program. One SNP, S440 (T→C) was detected at the TaCRT-D locus by genotyping a wheat recombinant inbred line (RIL) population (114 lines) developed from Opata 85 × W7984. The TaCRT-D was then fine mapped between markers Xgwm645 and Xgwm664 on chromosome 3DL, corresponding to genetic distances of 3.5 and 4.4 cM, respectively, using the RIL population and Chinese Spring nulli-tetrasomic lines. Finally, the genome-specific and allele-specific markers were developed for the TaCRT-D gene. These findings indicate that TaCRT-D function importantly in plant stress responses, providing a gene target for genetic engineering to increase plant stress tolerance and the functional markers of TaCRT-D for marker-assistant selection in wheat breeding.

  20. CRT-D Therapy in Patients with Decompensated NYHA Class-Four CHF

    Directory of Open Access Journals (Sweden)

    Faisal Zaeem

    2012-01-01

    Full Text Available Background. ACC-HRS Guidelines for Cardiac Resynchronization Therapy ICD implantation (CRT-D do not include patients with advanced nonambulatory NYHA class-four CHF due to an expectation of limited survival. There is little data available from these large multicenter randomized studies to support or refute this claim. Purpose. We evaluated the outcomes of patients with advanced nonambulatory NYHA class-four CHF who received CRT-D devices as an attempt to improve the clinical status and promote hospital discharge. Methods. Sixteen (of our six hundred and seventy CRT-D patients were classified as advanced nonambulatory NYHA Class four inotrope/vasodilator/diuretic-dependent patients. These patients were analyzed retrospectively for weaning success to oral medications, hospital discharge, hemodynamic stability, and survival over eighteen months. Results. Thirteen of sixteen patients were discharged to home within two weeks of implantation. The survival to hospital discharge, as well as at six, twelve, and eighteen months was positive (ninety-four percent, seventy-five percent, sixty-nine percent, sixty-nine percent, resp.. The groups showed significant improvements in systolic blood pressure, renal function, left ventricular ejection fraction, and CHF class. Conclusion. CRT-D in advanced nonambulatory NYHA four patients proved feasible and beneficial. These findings suggest that the strategy merits further study.

  1. Ergonomic evaluation of CRT display in new control panels for nuclear power stations

    International Nuclear Information System (INIS)

    Kabazawa, Yoshihiko

    1983-01-01

    New control panels are to support powerfully the synthetic judgement function of operators by processing enormous plant data in the normal operation and at the time of accidents in nuclear power stations, and displaying the results in collective and ordered form on CRTs. This time, by carrying out the evaluation of new control panels using human engineering method, it was able to be confirmed that the new control panels have achieved the initial objectives, and to determine the criteria for the ergonomic evaluation of central control panels mainly with CRT display. Besides, it is considered that the application to wide range can be expected for this evaluation, not only to the CRT display system of the new control panels for nuclear power stations but also to other CRT images, therefore, the outline is reported. Chubu Electric Power Co., Inc. plans to adopt the new control panels with CRT display effectively utilizing process computers hereafter. It is necessary to give sufficient consideration to the method of using CRT images, the kinds of displayed images, colors and the form and arrangement of letters and symbols. 12 CRTs are used for the new control panel. The results are reflected to the control panel for Hamaoka No.3 plant. (Kako, I.)

  2. Rectal cancer: assessment of complete response to preoperative combined radiation therapy with chemotherapy--conventional MR volumetry versus diffusion-weighted MR imaging.

    Science.gov (United States)

    Curvo-Semedo, Luís; Lambregts, Doenja M J; Maas, Monique; Thywissen, Thomas; Mehsen, Rana T; Lammering, Guido; Beets, Geerard L; Caseiro-Alves, Filipe; Beets-Tan, Regina G H

    2011-09-01

    To determine diagnostic performance of diffusion-weighted (DW) magnetic resonance (MR) imaging for assessment of complete tumor response (CR) after combined radiation therapy with chemotherapy (CRT) in patients with locally advanced rectal cancer (LARC) by means of volumetric signal intensity measurements and apparent diffusion coefficient (ADC) measurements and to compare the performance of DW imaging with that of T2-weighted MR volumetry. A retrospective analysis of 50 patients with LARC, for whom clinical and imaging data were retrieved from a previous imaging study approved by the local institutional ethical committee and for which all patients provided informed consent, was conducted. Patients underwent pre- and post-CRT standard T2-weighted MR and DW MR. Two independent readers placed free-hand regions of interest (ROIs) in each tumor-containing section on both data sets to determine pre- and post-CRT tumor volumes and tumor volume reduction rates (volume). ROIs were copied to an ADC map to calculate tumor ADCs. Histopathologic findings were the standard of reference. Receiver operating characteristic (ROC) curves were generated to compare performance of T2-weighted and DW MR volumetry and ADC. The intraclass correlation coefficient (ICC) was used to evaluate interobserver variability and the correlation between T2-weighted and DW MR volumetry. Areas under the ROC curve (AUCs) for identification of a CR that was based on pre-CRT volume, post-CRT volume, and volume, respectively, were 0.57, 0.70, and 0.84 for T2-weighted MR versus 0.63, 0.93, and 0.92 for DW MR volumetry (P = .15, .02, .42). Pre- and post-CRT ADC and ADC AUCs were 0.55, 0.54, and 0.51, respectively. Interobserver agreement was excellent for all pre-CRT measurements (ICC, 0.91-0.96) versus good (ICC, 0.61-0.79) for post-CRT measurements. ICC between T2-weighted and DW MR volumetry was excellent (0.97) for pre-CRT measurements versus fair (0.25) for post-CRT measurements. Post-CRT DW MR

  3. 78 FR 16299 - Proposed Extension of the Approval of Information Collection Requirements

    Science.gov (United States)

    2013-03-14

    ... Federal minimum wage, overtime pay, recordkeeping, and youth employment standards of most general... DEPARTMENT OF LABOR Wage and Hour Division RIN 1235-0018 Proposed Extension of the Approval of Information Collection Requirements AGENCY: Wage and Hour Division, Department of Labor. ACTION: Notice...

  4. Constructing target product profiles (TPPs) to help vaccines overcome post-approval obstacles

    OpenAIRE

    Lee, Bruce Y.; Burke, Donald S.

    2009-01-01

    As history has demonstrated, post-approval obstacles can impede a vaccine’s use and potentially lead to its withdrawal. Addressing these potential obstacles when changes in a vaccine’s technology can still be easily made may improve a vaccine’s chances of success. Augmented vaccine target product profiles (TPPs) can help vaccine scientists better understand and anticipate these obstacles and galvanize conversations among various vaccine stakeholders (e.g., scientists, marketers, business deve...

  5. [HPV DNA vaccines expressing recombinant CRT/HPV6bE7 fusion protein inhibit tumor growth and angiogenic activity].

    Science.gov (United States)

    Xu, Yan; Cheng, Hao; Zhao, Ke-Jia; Zhu, Ke-Jian; Zhang, Xing

    2007-11-01

    This paper was to study the angiogenic inhibitory effect and the potential antitumor effect of the constructed recombinant DNA vaccine CRT/HPV6bE7 in vivo. The C57BL/6 mice were vaccinated respectively with recombinant CRT/HPV6bE7 DNA plamids. The inhibitory effects on angiogenesis of generated vaccines in vivo were evaluated by a bFGF-induced angiogenesis assay using the Matrigel kit. To investigate the potential antitumor effect, the mean tumor weights, sizes and tumor appearing times were measured in C57BL/6 mice treated with HPV6bE7-expressing B16 cells. The results indicated that the recombinants CRT180/HPV6bE7 and CRT180 showed strong anti-angiogenic effects in bFGF-induced angiogenesis in vivo. Moreover, CRT180/HPV6bE7 and CRT180 DNA vaccines could significantly inhibit the tumor growth in tumor challenge experiment, and CRT180/HPV6bE7 was superior to other vaccines in delaying tumor formation time, limiting tumor size and weight in tumor protection experiment. In conclusion, recombinant CRT180/HPV6bE7 DNA could elicit a most efficient anti-angiogenic effect and inhibit tumor growth in mice inoculated with DNA vaccines. The antiangiogenic activity of CRT were suggested residing in a domain between CRT 120-180 aa.

  6. 78 FR 36560 - 30-Day Notice of Proposed Information Collection: FHA Lender Approval, Annual Renewal, Periodic...

    Science.gov (United States)

    2013-06-18

    ... 92001-C Non-compliances on Title I Lenders Description of the need for the information and proposed use... Information Collection: FHA Lender Approval, Annual Renewal, Periodic Updates and Noncompliance Reporting by FHA Approved Lenders AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY...

  7. 75 FR 12251 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Science.gov (United States)

    2010-03-15

    ... Lenders. OMB Control Number, if applicable: 2502-0005. Description of the need for the information and proposed use: The information is used by FHA to verify that lenders meet all approval, renewal, update and... Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and...

  8. 78 FR 17937 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Science.gov (United States)

    2013-03-25

    ... Lenders. OMB Control Number, if applicable: 2502-0005. Description of the need for the information and proposed use: The information is used by FHA to verify that lenders meet all approval, renewal, update and... Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and...

  9. 77 FR 63323 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Science.gov (United States)

    2012-10-16

    ... Lenders OMB Control Number, if applicable: 2502-0005. Description of the need for the information and proposed use: The information is used by FHA to verify that lenders meet all approval, renewal, update and... Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and...

  10. 76 FR 55148 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change To Adopt...

    Science.gov (United States)

    2011-09-06

    ...-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change To Adopt Rules for the...-4 thereunder,\\2\\ a proposed rule change to adopt rules for the qualification, listing, and delisting... the Proposal The Exchange proposes rules to adopt a program for the qualification, listing, and...

  11. Towards multidimensional radiotherapy (MD-CRT): biological imaging and biological conformality

    International Nuclear Information System (INIS)

    Ling, C. Clifton; Humm, John; Larson, Steven; Amols, Howard; Fuks, Zvi; Leibel, Steven; Koutcher, Jason A.

    2000-01-01

    Purpose: The goals of this study were to survey and summarize the advances in imaging that have potential applications in radiation oncology, and to explore the concept of integrating physical and biological conformality in multidimensional conformal radiotherapy (MD-CRT). Methods and Materials: The advances in three-dimensional conformal radiotherapy (3D-CRT) have greatly improved the physical conformality of treatment planning and delivery. The development of intensity-modulated radiotherapy (IMRT) has provided the 'dose painting' or 'dose sculpting' ability to further customize the delivered dose distribution. The improved capabilities of nuclear magnetic resonance imaging and spectroscopy, and of positron emission tomography, are beginning to provide physiological and functional information about the tumor and its surroundings. In addition, molecular imaging promises to reveal tumor biology at the genotype and phenotype level. These developments converge to provide significant opportunities for enhancing the success of radiotherapy. Results: The ability of IMRT to deliver nonuniform dose patterns by design brings to fore the question of how to 'dose paint' and 'dose sculpt', leading to the suggestion that 'biological' images may be of assistance. In contrast to the conventional radiological images that primarily provide anatomical information, biological images reveal metabolic, functional, physiological, genotypic, and phenotypic data. Important for radiotherapy, the new and noninvasive imaging methods may yield three-dimensional radiobiological information. Studies are urgently needed to identify genotypes and phenotypes that affect radiosensitivity, and to devise methods to image them noninvasively. Incremental to the concept of gross, clinical, and planning target volumes (GTV, CTV, and PTV), we propose the concept of 'biological target volume' (BTV) and hypothesize that BTV can be derived from biological images and that their use may incrementally improve

  12. 75 FR 30861 - Proposed Extension of the Approval of Information Collection Requirements

    Science.gov (United States)

    2010-06-02

    ... industrial homework as necessary to prevent circumvention or evasion of the minimum wage requirements of the... at not less than 85 percent of the applicable minimum wage or less than $1.60, whichever is higher... DEPARTMENT OF LABOR Wage and Hour Division Proposed Extension of the Approval of Information...

  13. 76 FR 2737 - Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed...

    Science.gov (United States)

    2011-01-14

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63668; File No. SR-NSCC-2010-09] Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed Rule Change... Facility January 6, 2011. I. Introduction On August 30, 2010, the National Securities Clearing Corporation...

  14. 77 FR 57630 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a Proposed Rule Change Amending...

    Science.gov (United States)

    2012-09-18

    ... change was published for comment in the Federal Register on July 30, 2012.\\3\\ The Commission received no comment letters regarding the proposed rule change. This order approves the proposed rule change. \\1\\ 15 U...

  15. Awarable complexity: a study on CRT picture design based on plant images by NPP operators

    International Nuclear Information System (INIS)

    Kawano, Ryutaro; Ohtsuka, Tsutomu; Masugi, Tsuyoshi

    2000-01-01

    Original pictures installed in the 1st and 2nd generation type central control panels (CCP) and new 'Awarable and Complex' pictures were made on personal computers and evaluated. A total 18 of actual plant operators (M=32.3, SD=10.5 years old) participated in the evaluation. The operators rated the new CRT pictures highly. The response times using the new CRT pictures were shorter than those by the original pictures. Both results suggested that the CRT picture design guidelines based on the operators' plant images were effective for improving their performance. (author)

  16. 76 FR 45308 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

    Science.gov (United States)

    2011-07-28

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change To... change should provide NOM Participants assistance in effectively managing their quotations. \\6\\ 15 U.S.C...,\\2\\ a proposed rule change to adopt a new risk monitor mechanism. The proposed rule change was...

  17. Dose distribution of IMRT and 3D-CRT on treating central non-small-cell lung cancer

    International Nuclear Information System (INIS)

    Zhu Xiaoyang; Yu Guangwei

    2010-01-01

    3D-CRT and IMRT were used in the radiation therapy of Central Non-small-cell lung cancer (NSCLC), and the dose difference of the methods was estimated. Thirty-two patients suffering with II class NSCLC were selected. Based on CT images, each patient was given 1 3D-CRT (3 dimensional conformal radiotherapy) and 2 IMRT(intensity modulated radiation therapy) treatment plans (5 fields and 7 fields), respectively, and the dose distribution was evaluated too. The results showed that PTVD mean and the PTV max , PTVD max (%) and CI of IMRT were both higher than those of 3D-CRT, but the uniformity was not as good as 3D-CRT. All indexes of lung and spinal cord treated with IMRT were lower than that treated with 3D-CRT. Moreover, there was no significance of the difference between 5 fields and 7 fields. In a conclusion, IMRT could not only decrease the target dose of NSCLC, but it can protect normal tissue from radiation damage effectively. And when IMRT was used, 5 fields might be enough. (authors)

  18. Kombinasi RSA-CRT dengan Random LSB untuk Keamanan Data di Kanwil Kementerian Agama Prov. Sumatera Utara

    Directory of Open Access Journals (Sweden)

    Niti Ravika Nasution

    2017-04-01

    Full Text Available In this study the authors use Cryptographic Algorithms Rivest Shamir Adleman Chinese Remainder Theorem (RSA-CRT and steganography technique Random Least Significant Bits (LSB. RSA-CRT is basically the same as usual, but utilizing RSA CRT theorem to shorten the bit size decryption exponent d by hiding d on congruent systems that accelerate time decryption, the difference in the key generation process and the decryption process. Cryptographic algorithm RSA-CRT produce ciphertext stored into a picture (image using Steganography technique Random Least Significant Bits (LSB. The workings of Random LSB is storing the message (ciphertext in the first bit or the second bit random key for use random number generator Pseudo Random Number Generator (PRNG with Linear Congruential Generator (LCG method. Ciphertext stored in a picture  (image has extracted key re-use random number generator at the time of inserting the message. Then the ciphertext is decrypted back by the algorithm RSA-CRT to produce the original text (plaintext. Merging Cryptographic Algorithm RSA-CRT with Steganography Technique Simple  LSB than with Random LSB generate higher PSNR and MSE is lower, which means better level of data security and more resistant to attack. Has more difficult to find a secret message by cryptanalysis and steganalyst.

  19. Encapsulation of lead from hazardous CRT glass wastes using biopolymer cross-linked concrete systems

    International Nuclear Information System (INIS)

    Kim, Daeik; Quinlan, Michael; Yen, Teh Fu

    2009-01-01

    Discarded computer monitors and television sets are identified as hazardous materials due to the high content of lead in their cathode ray tubes (CRTs). Over 98% of lead is found in CRT glass. More than 75% of obsolete electronics including TV and CRT monitors are in storage because appropriate e-waste management and remediation technologies are insufficient. Already an e-waste tsunami is starting to roll across the US and the whole world. Thus, a new technology was developed as an alternative to current disposal methods; this method uses a concrete composite crosslinked with minute amounts of biopolymers and a crosslinking agent. Commercially available microbial biopolymers of xanthan gum and guar gum were used to encapsulate CRT wastes, reducing Pb leachability as measured by standard USEPA methods. In this investigation, the synergistic effect of the crosslinking reaction was observed through blending two different biopolymers or adding a crosslinking agent in biopolymer solution. This CRT-biopolymer-concrete (CBC) composite showed higher compressive strength than the standard concrete and a considerable decrease in lead leachability

  20. PEPR and other CRT scanning and measuring devices

    Energy Technology Data Exchange (ETDEWEB)

    Pless, Irwin A. (Massachusetts Institute of Technology, Cambridge, MA 02139 (United States))

    1994-07-01

    This talk concentrates on the brief history of the PEPR (Precision Encoding and Pattern Recognition) scanning and measuring device.I restrict this reminiscence to just a short history of PEPR, the other various CRT scanners, a short summary of the capabilities of this scanner and some fond memories. ((orig.))

  1. PEPR and other CRT scanning and measuring devices

    International Nuclear Information System (INIS)

    Pless, Irwin A.

    1994-01-01

    This talk concentrates on the brief history of the PEPR (Precision Encoding and Pattern Recognition) scanning and measuring device.I restrict this reminiscence to just a short history of PEPR, the other various CRT scanners, a short summary of the capabilities of this scanner and some fond memories. ((orig.))

  2. RAPIDARC (RA) in the uterine cervical cancer; dosimetric gain vs 3D-Crt; RAPIDARC (RA) en el cancer de cervix uterino; ganancia dosimetrica vs 3D-CRT

    Energy Technology Data Exchange (ETDEWEB)

    Ramirez, J.; Garcia, B.; Quispe, K.; Gonzales, A.; Marquina, J., E-mail: jose.ramirez@aliada.com.pe [Clinica Aliada, Oncologia Integral, Av. Jose Galvez Barrenechea 1044, San Isidro, Lima (Peru)

    2014-08-15

    This work aims to quantitatively assess RAPIDARC (RA) treatments versus three dimensional-Conformal Radiation Therapy with field to field technique (3D-Crt-Fin F). 11 patients with cervical cancer treated at our institution radically or adjuvant clinical stages I-III B were evaluated. The prescribed dose was 50 Gy (2 Gy / Fr). The RA plans consisted of two isocentric complete arcs and conformational plans of 4 isocentric fields (previous, subsequent, right side and left side) with 3D-Crt-Fin F technique; both cases carried out ??in the Eclipse version 10 planner with calculation algorithm analytical anisotropic algorithm (AAA) and volumetric optimization software (for VMAT plans). Homogeneity indices (Hi), conformity indices (CI) Sigma indices (S-Index), monitor units (MU) and the time required for each treatment were compared. The mean age was 52 years (32-65) of the 11 patients 9 were clinical stages I-II B. The Hi varied from 0.052 for RA to 0.163 for 3D-Crt-Fin F (p = 0.009), and the CI between 1.005 and 1.35 (p = 0.26), the S-index from 1.2 to 3.7 (p = 0.001) and the H-index of 1.08 to 1.15 (p = 0.24). All dose limits in risk organs were met with a significant difference in the RA plans versus 3D-Crt-Fin F. In patients with cervical cancer the treatment plans quality with the indices aforementioned seems to be better with the RA technique, being observed a significant reduction of radiation to surrounding organs. (author)

  3. Chlorpheniramine Analogues Reverse Chloroquine Resistance in Plasmodium falciparum by Inhibiting PfCRT.

    Science.gov (United States)

    Deane, Karen J; Summers, Robert L; Lehane, Adele M; Martin, Rowena E; Barrow, Russell A

    2014-05-08

    The emergence and spread of malaria parasites that are resistant to chloroquine (CQ) has been a disaster for world health. The antihistamine chlorpheniramine (CP) partially resensitizes CQ-resistant (CQR) parasites to CQ but possesses little intrinsic antiplasmodial activity. Mutations in the parasite's CQ resistance transporter (PfCRT) confer resistance to CQ by enabling the protein to transport the drug away from its site of action, and it is thought that resistance-reversers such as CP exert their effect by blocking this CQ transport activity. Here, a series of new structural analogues and homologues of CP have been synthesized. We show that these compounds (along with other in vitro CQ resistance-reversers) inhibit the transport of CQ via a resistance-conferring form of PfCRT expressed in Xenopus laevis oocytes. Furthermore, the level of PfCRT-inhibition was found to correlate well with both the restoration of CQ accumulation and the level of CQ resensitization in CQR parasites.

  4. Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

    Science.gov (United States)

    Merkely, Bela; Kosztin, Annamaria; Roka, Attila; Geller, Laszlo; Zima, Endre; Kovacs, Attila; Boros, Andras Mihaly; Klein, Helmut; Wranicz, Jerzy K; Hindricks, Gerhard; Clemens, Marcell; Duray, Gabor Z; Moss, Arthur J; Goldenberg, Ilan; Kutyifa, Valentina

    2017-09-01

    There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF ≤ 35%, NYHA functional classes II-IVa, paced QRS ≥ 150 ms, and a RV pacing ≥ 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing. NCT02270840. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  5. Molecular interaction of selected phytochemicals under the charged environment of Plasmodium falciparum chloroquine resistance transporter (PfCRT) model.

    Science.gov (United States)

    Patel, Saumya K; Khedkar, Vijay M; Jha, Prakash C; Jasrai, Yogesh T; Pandya, Himanshu A; George, Linz-Buoy; Highland, Hyacinth N; Skelton, Adam A

    2016-01-01

    Phytochemicals of Catharanthus roseus Linn. and Tylophora indica have been known for their inhibition of malarial parasite, Plasmodium falciparum in cell culture. Resistance to chloroquine (CQ), a widely used antimalarial drug, is due to the CQ resistance transporter (CRT) system. The present study deals with computational modeling of Plasmodium falciparum chloroquine resistance transporter (PfCRT) protein and development of charged environment to mimic a condition of resistance. The model of PfCRT was developed using Protein homology/analogy engine (PHYRE ver 0.2) and was validated based on the results obtained using PSI-PRED. Subsequently, molecular interactions of selected phytochemicals extracted from C. roseus Linn. and T. indica were studied using multiple-iterated genetic algorithm-based docking protocol in order to investigate the translocation of these legends across the PfCRT protein. Further, molecular dynamics studies exhibiting interaction energy estimates of these compounds within the active site of the protein showed that compounds are more selective toward PfCRT. Clusters of conformations with the free energy of binding were estimated which clearly demonstrated the potential channel and by this means the translocation across the PfCRT is anticipated.

  6. 75 FR 3509 - Public Company Accounting Oversight Board; Order Approving Proposed Rules on Auditing Standard No...

    Science.gov (United States)

    2010-01-21

    ... Accounting Oversight Board; Order Approving Proposed Rules on Auditing Standard No. 7, Engagement Quality... (the ``Commission'') a notice (the ``Notice'') of proposed rules (File No. PCAOB-2009-02) on Auditing... identify any significant engagement deficiencies before it issues its audit report. Auditing Standard No. 7...

  7. 77 FR 66196 - Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2012-11-02

    ... Accounting Principles (``GAAP''). Canadian clearing members that use Form 1 report the same, and in some... Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Financial... financial reporting by Canadian clearing members to reflect the Investment Industry Regulatory Organization...

  8. 76 FR 78059 - Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2011-12-15

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65927; File No. SR-OCC-2011-15] Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Management of..., future regulatory requirements for clearinghouses could impose liquidity requirements that would be...

  9. Domestic comparison of radiation treatment techniques for breast cancer: 3D-CRT, IMRT and VMAT

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Bo Ram; Yoon, Myong Geun [Dept. of Bio-convergence Engineering, College of Health Science, Korea University, Seoul (Korea, Republic of); Lee, Sun Young [Dept. of Radiation Oncology, Yusung Sun Medical Center, Daejeon (Korea, Republic of)

    2013-09-15

    The purpose of this study is to compare method in the treatment of breast cancer using dose index. And, it is to find the optimized treatment technique to the patient. The phantom filled with tissue-equivalent material were used simulation and treatment as techniques of 3D-CRT, IMRT, VMAT was planned using Eclipse v10. By using HI(homogeneity index), CI(Conformity index), OE (Organ equivalent dose), EAR(Excess Absolute Risk), were assessed for each treatment plans. HI and CI of 3D-CRT, IMRT, VMAT were calculated 16.89, 11.21, 9.55 and 0.59, 0.61, 0.83. The organ average doses of Lt lung, Rt lung, liver, heart, esophagus, cord, Lt breast, trachea and stomach were 0.01 ∼ 2.02 Gy, 0.36 ∼ 5.01 Gy, 0.25 ∼ 2.49 Gy, 0.14 ∼ 6.92 Gy, 0.03 ∼ 2.02 Gy, 0.01 ∼ 1.06 Gy, 0.25 ∼ 6.08 Gy, 0.08 ∼ 0.59 Gy, 0.01 ∼ 1.34 Gy, respectively. The OED, EAR of the IMRT and VMAT show higher than 3D-CRT. As the result of this study, we could confirm being higher dose index(HI, CI) in IMRT and VMAT than 3D-CRT, but doses of around normal organs was higher IMRT, VMAT than 3D-CRT.

  10. Are thoughtful people more utilitarian? CRT as a unique predictor of moral minimalism in the dilemmatic context.

    Science.gov (United States)

    Royzman, Edward B; Landy, Justin F; Leeman, Robert F

    2015-03-01

    Recent theorizing about the cognitive underpinnings of dilemmatic moral judgment has equated slow, deliberative thinking with the utilitarian disposition and fast, automatic thinking with the deontological disposition. However, evidence for the reflective utilitarian hypothesis-the hypothesized link between utilitarian judgment and individual differences in the capacity for rational reflection (gauged here by the Cognitive Reflection Test [CRT; Frederick, 2005]) has been inconsistent and difficult to interpret in light of several design flaws. In two studies aimed at addressing some of the flaws, we found robust evidence for a reflective minimalist hypothesis-high CRT performers' tendency to regard utility-optimizing acts as largely a matter of personal prerogative, permissible both to perform and to leave undone. This relationship between CRT and the "minimalist" orientation remained intact after controlling for age, sex, trait affect, social desirability, and educational attainment. No significant association was found between CRT and the strict utilitarian response pattern or CRT and the strict deontological response pattern, nor did we find any significant association between CRT and willingness to act in the utility-optimizing manner. However, we found an inverse association between empathic concern and a willingness to act in the utility-optimizing manner, but there was no comparable association between empathic concern and the deontological judgment pattern. Theoretical, methodological, and normative implications of the findings are discussed. Copyright © 2014 Cognitive Science Society, Inc.

  11. Full-scale mark II CRT program facility description report

    International Nuclear Information System (INIS)

    Namatame, Ken; Kukita, Yutaka; Ito, Hideo; Yamamoto, Nobuo; Shiba, Masayoshi

    1980-03-01

    Started in fiscal year 1977, the Full-Scale Mark II CRT (Containment Response Test) Program is proceeding for the period of five years. The primary objective of the CRT Program is to provide a data base for evaluation of the pressure suppression pool hydrodynamic loads associated with a postulated loss-of-coolant accident in the BWR Mark II containment system. The test facility was designed and constructed from fiscal year 1977 to 1978, and completed in March 1979. It is 1/18 in volume and has a wetwell which is a full-scale replica of one 20 0 -sector of that of a reference Mark II. This report describes design concepts, dimensions and constructions of the test facility, as well as specifications, locations and installation schemes of the measuring equipments. Results of soil structure inspection, vacuum breaker test and shaker test of the containment shell are given in the appendices. (author)

  12. SjCRT, a recombinant Schistosoma japonicum calreticulin, induces maturation of dendritic cells and a Th1-polarized immune response in mice

    Directory of Open Access Journals (Sweden)

    Lizhen Ma

    2017-11-01

    Full Text Available Abstract Background It is well known that immunization of radiation-attenuated (RA schistosoma cercariae or schistosomula can induce high levels of protective immunity against schistosoma cercariae reinfection in many animals. Many studies have shown that the Th1 cellular immune response is crucial for the protective effect elicited by RA schistosomula. However, the molecular mechanism of this strong protective immunity remains unclear. Methods The expression profiles of Schistosoma japonicum calreticulin (SjCRT in RA and normal schistosoma-derived cells were investigated by flow cytometry. The effect of recombinant SjCRT (rSjCRT on mouse dendritic cells (DCs was determined by FACS, ELISA and RT-PCR analysis. We also analyzed the effects of SjCRT on the activation of spleen cells from mice immunized with rSjCRT by detecting lymphocyte proliferation and the cytokine profiles of splenocytes. Results We found that the expression level of SjCRT in the cells from RA larvae was significantly higher than that in cells from normal schistosomula at early stages of development (day 4. The results of effect of rSjCRT on mouse DCs showed that rSjCRT could induce phenotypic and functional maturation of DCs, and SjCRT bound to the surface of DCs through the CD91 receptor and could be engulfed by DCs. The results of activation of splenocytes from mice immunized with rSjCRT also demonstrate that rSjCRT can effectively stimulate the proliferative response of splenic lymphocytes, elicit splenocytes from immunized mice to secrete high levels of IFN-γ, TNF-α and IL-4, and activate CD4+ T cells to produce high levels of IFN-γ. Conclusion SjCRT is one of the immunostimulatory molecules released from RA schistosomula cells, might play a crucial role in conferring a Th1-polarized immune response induced by RA cercariae/schistosomula in mice, and is a candidate molecule responsible for the high levels of protective immunity induced by RA schistosomula.

  13. 75 FR 2915 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...

    Science.gov (United States)

    2010-01-19

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61317; File No. SR-ISE-2009-103] Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed Rule Change Relating to Market Data Fees January 8, 2010. I. Introduction On November 25, 2009, the International...

  14. 77 FR 4852 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...

    Science.gov (United States)

    2012-01-31

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66234; File No. SR-ISE-2011-82] Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed Rule Change Relating to Legging Orders January 25, 2012. I. Introduction On November 29, 2011, the International Securities...

  15. The Vitamin B12-Dependent Photoreceptor AerR Relieves Photosystem Gene Repression by Extending the Interaction of CrtJ with Photosystem Promoters

    Directory of Open Access Journals (Sweden)

    Mingxu Fang

    2017-03-01

    Full Text Available Purple nonsulfur bacteria adapt their physiology to a wide variety of environmental conditions often through the control of transcription. One of the main transcription factors involved in controlling expression of the Rhodobacter capsulatus photosystem is CrtJ, which functions as an aerobic repressor of photosystem genes. Recently, we reported that a vitamin B12 binding antirepressor of CrtJ called AerR is required for anaerobic expression of the photosystem. However, the mechanism whereby AerR regulates CrtJ activity is unclear. In this study, we used a combination of next-generation sequencing and biochemical methods to globally identify genes under control of CrtJ and the role of AerR in controlling this regulation. Our results indicate that CrtJ has a much larger regulon than previously known, with a surprising regulatory function under both aerobic and anaerobic photosynthetic growth conditions. A combination of in vivo chromatin immunoprecipitation-DNA sequencing (ChIP-seq and ChIP-seq and exonuclease digestion (ChIP-exo studies and in vitro biochemical studies demonstrate that AerR forms a 1:2 complex with CrtJ (AerR-CrtJ2 and that this complex binds to many promoters under photosynthetic conditions. The results of in vitro and in vivo DNA binding studies indicate that AerR-CrtJ2 anaerobically forms an extended interaction with the bacteriochlorophyll bchC promoter to relieve repression by CrtJ. This is contrasted by aerobic growth conditions where CrtJ alone functions as an aerobic repressor of bchC expression. These results indicate that the DNA binding activity of CrtJ is modified by interacting with AerR in a redox-regulated manner and that this interaction alters CrtJ’s function.

  16. 76 FR 64980 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed...

    Science.gov (United States)

    2011-10-19

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65548; File No. SR-ISE-2011-39] Self-Regulatory Organizations; International Securities Exchange, LLC; Order Approving a Proposed Rule Change Relating to Complex Orders October 13, 2011. I. Introduction On July 1, 2011, the International Securities Exchange...

  17. 77 FR 47472 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2012-08-08

    ... proposed rule change to make certain amendments that, in part, clarified the operation of the new Market... equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change, as Modified by...

  18. 77 FR 35455 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Granting Approval of Proposed...

    Science.gov (United States)

    2012-06-13

    ...-Regulatory Organizations; New York Stock Exchange LLC; Order Granting Approval of Proposed Rule Change Amending NYSE Rule 107B To Add a Class of Supplemental Liquidity Providers That Are Registered as Market... proposed rule change to amend NYSE Rule 107B to add a class of Supplemental Liquidity Providers (``SLP...

  19. Full-color laser cathode ray tube (L-CRT) projector

    Science.gov (United States)

    Kozlovskiy, Vladimir; Nasibov, Alexander S.; Popov, Yuri M.; Reznikov, Parvel V.; Skasyrsky, Yan K.

    1995-04-01

    A full color TV projector based on three laser cathode-ray tubes (L-CRT) is described. A water-cooled laser screen (LS) is the radiation element of the L-CRT. We have produced three main colors (blue, green and red) by using the LS made of three II-VI compounds: ZnSe ((lambda) equals 475 nm), CdS ((lambda) equals 530 nm) and ZnCdSe (630 nm). The total light flow reaches 1500 Lm, and the number of elements per line is not less than 1000. The LS efficiency may be about 10 Lm/W. In our experiments we have tested new electron optics: - (30 - 37) kV are applied to the cathode unit of the electron gun; the anode of the e-gun and the e-beam intensity modulator are under low potential; the LS has a potential + (30 - 37) kV. The accelerating voltage is divided into two parts, and this enables us to diminish the size and weight of the projector.

  20. 77 FR 13131 - Proposed Collection: Comment Request Post-Award Reporting Requirements Including New Research...

    Science.gov (United States)

    2012-03-05

    ... submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title... Administration, Centers for Disease Control and Prevention, and Agency for Healthcare Research and Quality (AHRQ... information technology. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project...

  1. 77 FR 38879 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

    Science.gov (United States)

    2012-06-29

    ... marketable non-displayed interest, the Market Maker would be required to re-enter a quotation for purposes of...-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change Adding New... Securities Exchange Act of 1934 (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to add new...

  2. 77 FR 46739 - Proposed Extension of Approval of Information Collection; Comment Request-Baby Bouncers and...

    Science.gov (United States)

    2012-08-06

    ... CONSUMER PRODUCT SAFETY COMMISSION Proposed Extension of Approval of Information Collection; Comment Request--Baby Bouncers and Walker-Jumpers AGENCY: Consumer Product Safety Commission. ACTION... information collection requirements for manufacturers and importers of children's articles known as baby...

  3. Resolution and noise measurements of five CRT and LCD medical displays

    International Nuclear Information System (INIS)

    Saunders, Robert S. Jr.; Samei, Ehsan

    2006-01-01

    The performance of soft-copy displays plays a significant role in the overall image quality of a digital radiographic system. In this work, we discuss methods to characterize the resolution and noise of both cathode ray tube (CRT) and liquid crystal display (LCD) devices. We measured the image quality of five different commercial display devices, representing both CRT and LCD technologies, using a high-quality charge-coupled device (CCD) camera. The modulation transfer function (MTF) was calculated using the line technique, correcting for the MTF of the CCD camera and the display pixel size. The normalized noise power spectrum (NPS) was computed from two-dimensional Fourier analysis of uniform images. To separate the effects of pixel structure from interpixel luminance variations, we created structure-free images by eliminating the pixel structures of the display device. The NPS was then computed from these structure-free images to isolate interpixel luminance variations. We found that the MTF of LCDs remained close to the theoretical limit dictated by their inherent pixel size (0.85±0.08 at Nyquist frequency), in contrast to the MTF for the two CRT displays, which dropped to 0.15±0.08 at the Nyquist frequency. However, the NPS of LCDs showed significant peaks due to the subpixel structure, while the NPS of CRT displays exhibited a nearly flat power spectrum. After removing the pixel structure, the structured noise peaks for LCDs were eliminated and the overall noise magnitude was significantly reduced. The average total noise-to-signal ratio for CRT displays was 6.55%±0.59%, of which 6.03%±0.24% was due to interpixel luminance variations, while LCD displays had total noise to signal ratios of 46.1%±5.1% of which 1.50%±0.41% were due to interpixel luminance variations. Depending on the extent of the blurring and prewhitening processes of the human visual system, the magnitude of the display noise (including pixel structure) potentially perceived by the

  4. Comparison of radiotherapy dosimetry for 3D-CRT, IMRT, and SBRT based on electron density calibration

    International Nuclear Information System (INIS)

    Kartutik, K; Pawiro, S A; Wibowo, W E

    2016-01-01

    Accurate calculation of dose distribution affected by inhomogeneity tissue is required in radiotherapy planning. This study was performed to determine the ratio between radiotherapy planning using 3D-CRT, IMRT, and SBRT based on a calibrated curve of CT-number in the lung for different target's shape in 3D-CRT, IMRT, and spinal cord for SBRT. Calibration curves of CT-number were generated under measurement basis and introduced into TPS, then planning was performed for 3D-CRT, IMRT, and SBRT with 7, and 15 radiation fields. Afterwards, planning evaluation was performed by comparing the DVH curve, HI, and CI. 3D-CRT and IMRT produced the lowest HI at calibration curve of CIRS 002LFC with the value 0.24 and 10. Whereas SBRT produced the lowest HI on a linear calibration curve with a value of 0.361. The highest CI in IMRT and SBRT technique achieved using a linear calibration curve was 0.97 and 1.77 respectively. For 3D-CRT, the highest CI was obtained by using calibration curve of CIRS 062M with the value of 0.45. From the results of CI and HI, it is concluded that the calibration curve of CT-number does not significantly differ with Schneider's calibrated curve, and inverse planning gives a better result than forward planning. (paper)

  5. 77 FR 75243 - Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2012-12-19

    ... modeling and risk management procedures (``Risk Management Proposal'') \\9\\ is approved by the Commission... risk modeling enhancements with respect to longer-tenor options, including OTC S&P 500 Index Options... http://www.sec.gov/rules/petitions/2012/petn4-644.pdf . This Order does not address the relief...

  6. Cognitive remediation therapy (CRT) benefits more to patients with schizophrenia with low initial memory performances.

    Science.gov (United States)

    Pillet, Benoit; Morvan, Yannick; Todd, Aurelia; Franck, Nicolas; Duboc, Chloé; Grosz, Aimé; Launay, Corinne; Demily, Caroline; Gaillard, Raphaël; Krebs, Marie-Odile; Amado, Isabelle

    2015-01-01

    Cognitive deficits in schizophrenia mainly affect memory, attention and executive functions. Cognitive remediation is a technique derived from neuropsychology, which aims to improve or compensate for these deficits. Working memory, verbal learning, and executive functions are crucial factors for functional outcome. Our purpose was to assess the impact of the cognitive remediation therapy (CRT) program on cognitive difficulties in patients with schizophrenia, especially on working memory, verbal memory, and cognitive flexibility. We collected data from clinical and neuropsychological assessments in 24 patients suffering from schizophrenia (Diagnostic and Statistical Manual of mental Disorders-Fourth Edition, DSM-IV) who followed a 3-month (CRT) program. Verbal and visuo-spatial working memory, verbal memory, and cognitive flexibility were assessed before and after CRT. The Wilcoxon test showed significant improvements on the backward digit span, on the visual working memory span, on verbal memory and on flexibility. Cognitive improvement was substantial when baseline performance was low, independently from clinical benefit. CRT is effective on crucial cognitive domains and provides a huge benefit for patients having low baseline performance. Such cognitive amelioration appears highly promising for improving the outcome in cognitively impaired patients.

  7. 77 FR 55812 - Proposed Extension of Approval of Information Collection; Comment Request-Baby Bouncers and...

    Science.gov (United States)

    2012-09-11

    ... CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC-2012-0038] Proposed Extension of Approval of Information Collection; Comment Request--Baby Bouncers and Walker-Jumpers AGENCY: Consumer Product Safety... collection requirements for manufacturers and importers of children's articles known as baby-bouncers and...

  8. Comparison of dyssynchrony parameters for VV-optimization in CRT patients

    DEFF Research Database (Denmark)

    Risum, Niels; Søgaard, Peter; Hansen, Thomas F.

    2013-01-01

    Optimization of the interventricular delay (VV-optimization) in cardiac resynchronization therapy (CRT) patients can be performed by evaluation of mechanical dyssynchrony. However, there is no consensus on which method to use. In this study, three conceptually different methods were evaluated....

  9. 77 FR 15432 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

    Science.gov (United States)

    2012-03-15

    ... corporate governance structure of OCC by: (i) Increasing the number of public directors on OCC's Board of... directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds... Directors, OCC stated that the changes would enhance the corporate governance structure at OCC. As such, the...

  10. 78 FR 24257 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

    Science.gov (United States)

    2013-04-24

    ... positions are in-the- money or out-of-the-money. Volume, like open interest, is a measure of a Clearing... demands on OCC's services and facilities that are not captured by the current methodology. IV. Conclusion... Organizations; The Options Clearing Corporation; Order Approving Proposed Rule Change To Implement a Revised...

  11. Postoperative Radiotherapy for Prostate Cancer: A Comparison of Four Consensus Guidelines and Dosimetric Evaluation of 3D-CRT Versus Tomotherapy IMRT

    International Nuclear Information System (INIS)

    Malone, Shawn; Croke, Jennifer; Roustan-Delatour, Nicolas; Belanger, Eric; Avruch, Leonard; Malone, Colin; Morash, Christopher; Kayser, Cathleen; Underhill, Kathryn; Li Yan; Malone, Kyle; Nyiri, Balazs; Spaans, Johanna

    2012-01-01

    Purpose: Despite the benefits of adjuvant radiotherapy after radical prostatectomy, approximately one-half of patients relapse. Four consensus guidelines have been published (European Organization for Research and Treatment of Cancer, Faculty of Radiation Oncology Genito-Urinary Group, Princess Margaret Hospital, Radiation Therapy Oncology Group) with the aim of standardizing the clinical target volume (CTV) delineation and improve outcomes. To date, no attempt has been made to compare these guidelines in terms of treatment volumes or organ at risk (OAR) irradiation. The extent to which the guideline-derived plans meet the dosimetric constraints of present trials or of the Quantitative Analysis of Normal Tissue Effects in the Clinic (QUANTEC) trial is also unknown. Our study also explored the dosimetric benefits of intensity-modulated radiotherapy (IMRT). Methods and Materials: A total of 20 patients treated with postoperative RT were included. The three-dimensional conformal radiotherapy (3D-CRT) plans were applied to cover the guideline-generated planning target volumes (66 Gy in 33 fractions). Dose–volume histograms (DVHs) were analyzed for CTV/planning target volume coverage and to evaluate OAR irradiation. The OAR DVHs were compared with the constraints proposed in the QUANTEC and Radiotherapy and Androgen Deprivation In Combination After Local Surgery (RADICALS) trials. 3D-CRT plans were compared with the tomotherapy plans for the Radiation Therapy Oncology Group planning target volume to evaluate the advantages of IMRT. Results: The CTV differed significantly between guidelines (p < 0.001). The European Organization for Research and Treatment of Cancer-CTVs were significantly smaller than the other CTVs (p < 0.001). Differences in prostate bed coverage superiorly accounted for the major volumetric differences between the guidelines. Using 3D-CRT, the DVHs rarely met the QUANTEC or RADICALS rectal constraints, independent of the guideline used. The RADICALS

  12. 76 FR 30700 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Proposed...

    Science.gov (United States)

    2011-05-26

    ... agencies, and others to promote reductions in toxic chemical releases. Industrial facilities use the TRI... Activities; Submission to OMB for Review and Approval; Proposed Collections; Toxic Chemical Release Reporting... that manufacture, process, or otherwise use specified toxic chemicals in amounts above reporting...

  13. 77 FR 3531 - Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2012-01-24

    ... Organizations; The Depository Trust Company; Order Approving Proposed Rule Change To Enhance Risk Management.... Description The rule change will enhance the risk management controls associated with DTC's Receiver... Participant's net debit cap is placed on a pending (recycling) queue until another transaction creates...

  14. A monoallelic deletion of the TcCRT gene increases the attenuation of a cultured Trypanosoma cruzi strain, protecting against an in vivo virulent challenge.

    Directory of Open Access Journals (Sweden)

    Fernando J Sánchez-Valdéz

    2014-02-01

    Full Text Available Trypanosoma cruzi calreticulin (TcCRT is a virulence factor that binds complement C1, thus inhibiting the activation of the classical complement pathway and generating pro-phagocytic signals that increase parasite infectivity. In a previous work, we characterized a clonal cell line lacking one TcCRT allele (TcCRT+/- and another overexpressing it (TcCRT+, both derived from the attenuated TCC T. cruzi strain. The TcCRT+/- mutant was highly susceptible to killing by the complement machinery and presented a remarkable reduced propagation and differentiation rate both in vitro and in vivo. In this report, we have extended these studies to assess, in a mouse model of disease, the virulence, immunogenicity and safety of the mutant as an experimental vaccine. Balb/c mice were inoculated with TcCRT+/- parasites and followed-up during a 6-month period. Mutant parasites were not detected by sensitive techniques, even after mice immune suppression. Total anti-T. cruzi IgG levels were undetectable in TcCRT+/- inoculated mice and the genetic alteration was stable after long-term infection and it did not revert back to wild type form. Most importantly, immunization with TcCRT+/- parasites induces a highly protective response after challenge with a virulent T. cruzi strain, as evidenced by lower parasite density, mortality, spleen index and tissue inflammatory response. TcCRT+/- clones are restricted in two important properties conferred by TcCRT and indirectly by C1q: their ability to evade the host immune response and their virulence. Therefore, deletion of one copy of the TcCRT gene in the attenuated TCC strain generated a safe and irreversibly gene-deleted live attenuated parasite with high immunoprotective properties. Our results also contribute to endorse the important role of TcCRT as a T. cruzi virulence factor.

  15. RAPIDARC (RA) in the uterine cervical cancer; dosimetric gain vs 3D-Crt

    International Nuclear Information System (INIS)

    Ramirez, J.; Garcia, B.; Quispe, K.; Gonzales, A.; Marquina, J.

    2014-08-01

    This work aims to quantitatively assess RAPIDARC (RA) treatments versus three dimensional-Conformal Radiation Therapy with field to field technique (3D-Crt-Fin F). 11 patients with cervical cancer treated at our institution radically or adjuvant clinical stages I-III B were evaluated. The prescribed dose was 50 Gy (2 Gy / Fr). The RA plans consisted of two isocentric complete arcs and conformational plans of 4 isocentric fields (previous, subsequent, right side and left side) with 3D-Crt-Fin F technique; both cases carried out ??in the Eclipse version 10 planner with calculation algorithm analytical anisotropic algorithm (AAA) and volumetric optimization software (for VMAT plans). Homogeneity indices (Hi), conformity indices (CI) Sigma indices (S-Index), monitor units (MU) and the time required for each treatment were compared. The mean age was 52 years (32-65) of the 11 patients 9 were clinical stages I-II B. The Hi varied from 0.052 for RA to 0.163 for 3D-Crt-Fin F (p = 0.009), and the CI between 1.005 and 1.35 (p = 0.26), the S-index from 1.2 to 3.7 (p = 0.001) and the H-index of 1.08 to 1.15 (p = 0.24). All dose limits in risk organs were met with a significant difference in the RA plans versus 3D-Crt-Fin F. In patients with cervical cancer the treatment plans quality with the indices aforementioned seems to be better with the RA technique, being observed a significant reduction of radiation to surrounding organs. (author)

  16. Multicenter evaluation of rectal cancer reimaging post neoadjuvant (MERRION) therapy.

    LENUS (Irish Health Repository)

    Hanly, Ann M

    2014-04-01

    The aim of this study was to evaluate the utility of reimaging rectal cancer post-CRT (chemoradiotherapy) with magnetic resonance (MR) imaging of the pelvis for local staging and computed tomography of thorax, abdomen, and pelvis (CT TAP) to identify distant metastases.

  17. Locally advanced rectal cancer: post-chemoradiotherapy ADC histogram analysis for predicting a complete response.

    Science.gov (United States)

    Cho, Seung Hyun; Kim, Gab Chul; Jang, Yun-Jin; Ryeom, Hunkyu; Kim, Hye Jung; Shin, Kyung-Min; Park, Jun Seok; Choi, Gyu-Seog; Kim, See Hyung

    2015-09-01

    The value of diffusion-weighted imaging (DWI) for reliable differentiation between pathologic complete response (pCR) and residual tumor is still unclear. Recently, a few studies reported that histogram analysis can be helpful to monitor the therapeutic response in various cancer research. To investigate whether post-chemoradiotherapy (CRT) apparent diffusion coefficient (ADC) histogram analysis can be helpful to predict a pCR in locally advanced rectal cancer (LARC). Fifty patients who underwent preoperative CRT followed by surgery were enrolled in this retrospective study, non-pCR (n = 41) and pCR (n = 9), respectively. ADC histogram analysis encompassing the whole tumor was performed on two post-CRT ADC600 and ADC1000 (b factors 0, 600 vs. 0, 1000 s/mm(2)) maps. Mean, minimum, maximum, SD, mode, 10th, 25th, 50th, 75th, 90th percentile ADCs, skewness, and kurtosis were derived. Diagnostic performance for predicting pCR was evaluated and compared. On both maps, 10th and 25th ADCs showed better diagnostic performance than that using mean ADC. Tenth percentile ADCs revealed the best diagnostic performance on both ADC600 (AZ 0.841, sensitivity 100%, specificity 70.7%) and ADC1000 (AZ 0.821, sensitivity 77.8%, specificity 87.8%) maps. In comparison between 10th percentile and mean ADC, the specificity was significantly improved on both ADC600 (70.7% vs. 53.7%; P = 0.031) and ADC1000 (87.8% vs. 73.2%; P = 0.039) maps. Post-CRT ADC histogram analysis is helpful for predicting pCR in LARC, especially, in improving the specificity, compared with mean ADC. © The Foundation Acta Radiologica 2014.

  18. 77 FR 4605 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Order Granting Approval of Proposed Rule...

    Science.gov (United States)

    2012-01-30

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66231; File No. SR-EDGA-2011-40] Self-Regulatory Organizations; EDGA Exchange, Inc.; Order Granting Approval of Proposed Rule Change Amending EDGA Rule 11.9 January 24, 2012. On December 2, 2011, EDGA Exchange, Inc. (``Exchange'' or ``EDGA'') filed...

  19. 75 FR 30095 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving Proposed Rule Amending Its...

    Science.gov (United States)

    2010-05-28

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62157; File No. SR-NYSEArca-2010-28] Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving Proposed Rule Amending Its Schedule of Fees May 24, 2010. On April 12, 2010, NYSE Arca, Inc. (``NYSE Arca'') filed with the Securities and Exchange...

  20. A difficult case of esophageal and gastric double cancer with pleural and pericardial effusion following chemo-radiotherapy (CRT)

    International Nuclear Information System (INIS)

    Aoki, Taro; Kobayashi, Kenji; Tanida, Tsukasa; Hatano, Hisanori; Komori, Takamichi; Matsumoto, Takashi; Nishioka, Kiyonori; Uemura, Yoshio

    2007-01-01

    A 70-year-old man was presented with esophageal and gastric cancer pointed by his personal doctor in November 2002. Both of the esophageal and gastric cancer were diagnosed as multiples with cStage II and cStage IA, respectively. In consideration of the patient's quality of life (QOL), chemo-radiotherapy (CRT) for esophageal cancer was preceded, and then total gastrectomy was done. Although esophageal cancer was responded as being complete response (CR), 14 courses of FP therapy were added as supportive chemotherapy. Ten months following CRT, pericardial effusion was noticed, so that pericardiocentesis was performed. Also diuretic has been administered up to the present. Nineteen months following CRT, pleural effusion was noticed and thoracentesis was performed several times into both of the pleural cavities, and that was depending on the degree with OK-432 infusion. Consequently, the patient has been controlled well. As a treatment for esophageal and gastric double cancer, we chose CRT rather than esophagectomy because of the excessive invasiveness. Despite of CR, we have had a difficulty with pleural and pericardial effusions due to the late toxicity of radiotherapy. We need to pay attention to the late toxicity in the case of long-term survival following CRT. (author)

  1. Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study.

    Science.gov (United States)

    Zeitoun, Jean-David; Baron, Gabriel; Vivot, Alexandre; Atal, Ignacio; Downing, Nicholas S; Ross, Joseph S; Ravaud, Philippe

    2018-01-15

    Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.gov through September 2014 for novel anticancer agents approved by both the US Food and Drug Administration and the European Medicines Agency between 2005 and 2010. All relevant post-marketing trials were classified according to indication, primary outcome, starting date, sponsors, and planned enrollment. Supplemental indications were retrieved from regulatory documents and publication rate was assessed by two different methods. Ten novel anticancer agents were eligible: five were indicated for hematologic malignancies and the remaining five for solid cancers (three for kidney cancer). We identified 2,345 post-marketing trials; 1,362 (58.1%) targeted an indication other than the originally approved one. We observed extreme variations among drugs in both number of post-marketing trials (range 8-530) and overall population to be enrolled per trial (1-8,381). Post-marketing trials assessed almost all types of cancers, the three most frequently studied cancers being leukemia, kidney cancer and myeloma. In all, 6.6% of post-marketing trials had a clinical endpoint as a primary outcome, and 35.9% and 54.1% had a safety or surrogate endpoint, respectively, as a primary outcome. Nine drugs obtained approval for supplemental indications. The publication rate at 10 years was 12.3 to 26.1% depending on the analysis method. In conclusion, we found that post-marketing research in oncology is highly heterogeneous and the publication rate of launched trials is low. © 2017 UICC.

  2. A 128-slice CT scanner helpful in localising coronary sinus ostium during CRT-D implantation – case report

    International Nuclear Information System (INIS)

    Jaźwiec, Przemysław; Jagielski, Dariusz; Gać, Paweł

    2014-01-01

    Cardiac resynchronization therapy (CRT) has become a successful treatment option for symptomatic heart failure in patients with poor left ventricular (LV) systolic function and broad QRS complex in the surface electrocardiogram (ECG). In this report we present a case of a 70-year-old woman with advanced heart failure due to ischaemic heart disease who underwent an upgrade from VVIR stimulator (pacemaker, PM) to cardiac resynchronization therapy defibrillator (CRT-D). The first attempt was unsuccessful due to problems with inefficient cannulation of the orifice of the coronary sinus (CS). After performing a 3D reconstruction with a 128-slice CT scanner, it was possible to carry out the up-grade to CRT-D resulting in enormous clinical improvement. The case represents an example of the usefulness of 3D reconstruction with the 128-slice CT scanner used after failed CRT-D implantation due to difficulties with efficient cannulation of the coronary sinus orifice in a rare anatomical variant

  3. 77 FR 52096 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Order Approving a Proposed Rule Change, as...

    Science.gov (United States)

    2012-08-28

    ...'s rules, the financial and regulatory risk management controls and supervisory procedures required...-Regulatory Organizations; EDGX Exchange, Inc.; Order Approving a Proposed Rule Change, as Modified by... that broker-dealers appropriately control the risks associated with market access, so as not to...

  4. 75 FR 19436 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2010-04-14

    ..., the Commission is not publishing it for comment.\\4\\ This order approves the proposed rule change, as... NASDAQ OMX Corporate Governance Guidelines, however, provide a different standard for uncontested... contained in the Corporate Governance Guidelines; contested elections would remain subject to the plurality...

  5. 75 FR 2899 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2010-01-19

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61333; File No. SR-NYSE-2009-117] Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change Amending Its... regulatory program. III. Discussion and Commission's Findings After careful review, the Commission finds that...

  6. Vocations: The Link between Post-Compulsory Education and the Labour Market. What the Research Says For... Qualification & Approval Bodies

    Science.gov (United States)

    Wheelahan, Leesa; Buchanan, John; Yu, Serena

    2015-01-01

    This summary pulls together the relevant key findings for qualification and approval bodies from the research program "Vocations: The Link between Post-Compulsory Education and the Labour Market." The program was comprised of three different strands: (1) pathways from VET in Schools, (2) pathways within and between vocational education…

  7. Foaming of CRT panel glass powder with Na2CO3

    DEFF Research Database (Denmark)

    Petersen, Rasmus Rosenlund; König, Jakob; Smedskjær, Morten Mattrup

    melt, while Na2O becomes incorporated into the glass structure. We have quantified the melt expansion through density measurements and the Na2O incorporation is indicated by the decrease of the glass transition temperature (Tg) of the final foam glass. The glass foaming quality depends on the foaming......Recycling of cathode ray tube (CRT) glass remains a challenging task. The CRT glass consists of four glass types fused together: Funnel-, neck-, frit- and panel glass. The three former glasses contain toxic lead oxide, and therefore have a low recycling potential. The latter on the other hand...... is lead-free, but since barium and strontium oxide are present, panel glass is incompatible with most common recycling methods. However, foam glass production is a promising approach for the recycling of panel glass waste, since the process parameters can be changed according to the glass waste...

  8. 78 FR 62814 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

    Science.gov (United States)

    2013-10-22

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change To Assume... Authority and Supervision September 30, 2013. On July 31, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or...) Manipulation patterns that monitor solely NASDAQ activity, including patterns that monitor the Exchange's...

  9. 77 FR 65237 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

    Science.gov (United States)

    2012-10-25

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change...Tree Trust October 19, 2012. I. Introduction On August 15, 2012, The NASDAQ Stock Market LLC (``Nasdaq... temporary defensive strategies that are inconsistent with its investment strategies, the Fund's ability to...

  10. 77 FR 48570 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

    Science.gov (United States)

    2012-08-14

    ... Underlying Securities) of the NASDAQ Options Market rules.\\11\\ Additionally, the Target Component's and the...\\ Additionally, the Target Component's and the Benchmark Component's trading volume (in all markets in which the...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change Relating to the...

  11. 77 FR 52097 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Order Approving a Proposed Rule Change, as...

    Science.gov (United States)

    2012-08-28

    ... financial and regulatory risk management controls and supervisory procedures required by Rule 15c3-5 under...-Regulatory Organizations; EDGA Exchange, Inc.; Order Approving a Proposed Rule Change, as Modified by... that broker-dealers appropriately control the risks associated with market access, so as not to...

  12. 76 FR 52996 - Public Company Accounting Oversight Board; Order Approving Proposed Temporary Rule for an Interim...

    Science.gov (United States)

    2011-08-24

    ... Accounting Oversight Board; Order Approving Proposed Temporary Rule for an Interim Program of Inspection Related to Audits of Brokers and Dealers August 18, 2011. I. Introduction On June 21, 2011, the Public... that would be imposed on different categories of registered public accounting firms and classes of...

  13. 76 FR 52997 - Public Company Accounting Oversight Board; Order Approving Proposed Board Funding Final Rules for...

    Science.gov (United States)

    2011-08-24

    ... Accounting Oversight Board; Order Approving Proposed Board Funding Final Rules for Allocation of the Board's... August 18, 2011. I. Introduction On June 21, 2011, the Public Company Accounting Oversight Board (the... public accounting firm, in amounts that are sufficient to cover the costs of processing and reviewing...

  14. 76 FR 4968 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

    Science.gov (United States)

    2011-01-27

    ...-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change Relating to Listing and Trading Shares of the AdvisorShares Active Bear ETF January 19, 2011. I. Introduction On... of the security or investment in the portfolio. \\14\\ Under accounting procedures followed by the Fund...

  15. 78 FR 75437 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule...

    Science.gov (United States)

    2013-12-11

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-71004; File No. SR-Phlx-2013-101] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule Change Regarding the Short Term Options Program December 6, 2013. I. Introduction On October 3, 2013, NASDAQ OMX PHLX LLC...

  16. 77 FR 67851 - Self-Regulatory Organizations; BOX Options Exchange LLC; Order Approving Proposed Rule Change To...

    Science.gov (United States)

    2012-11-14

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68177; File No. SR-BOX-2012-003] Self-Regulatory Organizations; BOX Options Exchange LLC; Order Approving Proposed Rule Change To Amend the Price Improvement Period November 7, 2012. I. Introduction On July 25, 2012, BOX Options Exchange LLC (``Exchange...

  17. 76 FR 8793 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule...

    Science.gov (United States)

    2011-02-15

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63875; File No. SR-Phlx-2010-183] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule Change Expanding Its Short Term Option Program February 9, 2011. I. Introduction On December 15, 2010, NASDAQ OMX PHLX LLC...

  18. 75 FR 69491 - Self-Regulatory Organizations; Order Approving Proposed Rule Change by New York Stock Exchange...

    Science.gov (United States)

    2010-11-12

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63266; File No. SR-NYSE-2010-67] Self-Regulatory Organizations; Order Approving Proposed Rule Change by New York Stock Exchange LLC Changing the NYBX Order Execution Sequence November 5, 2010. I. Introduction On September 9, 2010, the New York...

  19. 75 FR 9988 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Granting Approval of Proposed Rule...

    Science.gov (United States)

    2010-03-04

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61590; File No. SR-Phlx-2009-113] Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Granting Approval of Proposed Rule Change Relating to Index Option Position Limits February 25, 2010. On December 29, 2009, NASDAQ OMX PHLX, Inc. (``Phlx'' or...

  20. 76 FR 2182 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule...

    Science.gov (United States)

    2011-01-12

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63654; File No. SR-Phlx-2010-158] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Order Granting Approval of Proposed Rule Change Establishing a $5 Strike Price Program January 6, 2011. I. Introduction On November 12, 2010, NASDAQ OMX PHLX LLC...

  1. 78 FR 15394 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2013-03-11

    ...-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change Adopting... paragraph (d) it contains a provision establishing how the transition period from NYSE Rule 477 will work... to announce the effective date of the new rules at least 30 days in advance in an Information...

  2. 77 FR 49034 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

    Science.gov (United States)

    2012-08-15

    ... entering new orders at inferior prices. This occurs because the current process directs the order to NASDAQ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change To Amend Rule... June 14, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange''), filed with the Securities and...

  3. 78 FR 62834 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

    Science.gov (United States)

    2013-10-22

    ... Fund of First Trust Exchange-Traded Fund VII October 9, 2013. I. Introduction On August 16, 2013, The... for the provision of custody, transfer agency, and accounting agent services with the same or with...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change...

  4. 76 FR 21085 - Self-Regulatory Organizations; NASDAQ Stock Market, LLC; Order Approving Proposed Rule Change To...

    Science.gov (United States)

    2011-04-14

    ...-Regulatory Organizations; NASDAQ Stock Market, LLC; Order Approving Proposed Rule Change To Amend The NASDAQ OMX Group, Inc. By- Laws April 8, 2011. I. Introduction On February 8, 2011, The NASDAQ Stock Market... vote cast either ``for'' or ``against'' that director's election. In its filing, NASDAQ noted that...

  5. Recovery of yttrium from fluorescent powder of cathode ray tube, CRT: Zn removal by sulphide precipitation

    International Nuclear Information System (INIS)

    Innocenzi, Valentina; De Michelis, Ida; Ferella, Francesco; Beolchini, Francesca; Kopacek, Bernd; Vegliò, Francesco

    2013-01-01

    Highlights: • Treatment of fluorescent powder of CRT waste. • Factorial experimental designs to study acid leaching of fluorescent powder and the purification of leach liquors. • Recover of yttrium by precipitation using oxalic acid. • Suitable flowsheet to recover yttrium from fluorescent powder. - Abstract: This work is focused on the recovery of yttrium and zinc from fluorescent powder of cathode ray tube (CRT). Metals are extracted by sulphuric acid in the presence of hydrogen peroxide. Leaching tests are carried out according to a 2 2 full factorial plan and the highest extraction yields for yttrium and zinc equal to 100% are observed under the following conditions: 3 M of sulphuric acid, 10% v/v of H 2 O 2 concentrated solution at 30% v/v, 10% w/w pulp density, 70 °C and 3 h of reaction. Two series of precipitation tests for zinc are carried out: a 2 2 full factorial design and a completely randomized factorial design. In these series the factors investigated are pH of solution during the precipitation and the amount of sodium sulphide added to precipitate zinc sulphide. The data of these tests are used to describe two empirical mathematical models for zinc and yttrium precipitation yields by regression analysis. The highest precipitation yields for zinc are obtained under the following conditions: pH equal to 2–2.5% and 10–12% v/v of Na 2 S concentrated solution at 10% w/v. In these conditions the coprecipitation of yttrium is of 15–20%. Finally further yttrium precipitation experiments by oxalic acid on the residual solutions, after removing of zinc, show that yttrium could be recovered and calcined to obtain the final product as yttrium oxide. The achieved results allow to propose a CRT recycling process based on leaching of fluorescent powder from cathode ray tube and recovery of yttrium oxide after removing of zinc by precipitation. The final recovery of yttrium is 75–80%

  6. Recovery of yttrium from fluorescent powder of cathode ray tube, CRT: Zn removal by sulphide precipitation

    Energy Technology Data Exchange (ETDEWEB)

    Innocenzi, Valentina, E-mail: valentina.innocenzi1@univaq.it [Department of Industrial Engineering and Information and Economy, University of L’Aquila, Via Giovanni Gronchi n.18, Nucleo Ind.le di Pile, 67100 L’Aquila (Italy); De Michelis, Ida; Ferella, Francesco [Department of Industrial Engineering and Information and Economy, University of L’Aquila, Via Giovanni Gronchi n.18, Nucleo Ind.le di Pile, 67100 L’Aquila (Italy); Beolchini, Francesca [Department of Marine Sciences, Polytechnic Institute of Marche, Via Brecce Bianche, 60131 Ancona (Italy); Kopacek, Bernd [SAT, Austrian Society for Systems Engineering and Automation, Gurkasse 43/2, A-1140 Vienna (Austria); Vegliò, Francesco [Department of Industrial Engineering and Information and Economy, University of L’Aquila, Via Giovanni Gronchi n.18, Nucleo Ind.le di Pile, 67100 L’Aquila (Italy)

    2013-11-15

    Highlights: • Treatment of fluorescent powder of CRT waste. • Factorial experimental designs to study acid leaching of fluorescent powder and the purification of leach liquors. • Recover of yttrium by precipitation using oxalic acid. • Suitable flowsheet to recover yttrium from fluorescent powder. - Abstract: This work is focused on the recovery of yttrium and zinc from fluorescent powder of cathode ray tube (CRT). Metals are extracted by sulphuric acid in the presence of hydrogen peroxide. Leaching tests are carried out according to a 2{sup 2} full factorial plan and the highest extraction yields for yttrium and zinc equal to 100% are observed under the following conditions: 3 M of sulphuric acid, 10% v/v of H{sub 2}O{sub 2} concentrated solution at 30% v/v, 10% w/w pulp density, 70 °C and 3 h of reaction. Two series of precipitation tests for zinc are carried out: a 2{sup 2} full factorial design and a completely randomized factorial design. In these series the factors investigated are pH of solution during the precipitation and the amount of sodium sulphide added to precipitate zinc sulphide. The data of these tests are used to describe two empirical mathematical models for zinc and yttrium precipitation yields by regression analysis. The highest precipitation yields for zinc are obtained under the following conditions: pH equal to 2–2.5% and 10–12% v/v of Na{sub 2}S concentrated solution at 10% w/v. In these conditions the coprecipitation of yttrium is of 15–20%. Finally further yttrium precipitation experiments by oxalic acid on the residual solutions, after removing of zinc, show that yttrium could be recovered and calcined to obtain the final product as yttrium oxide. The achieved results allow to propose a CRT recycling process based on leaching of fluorescent powder from cathode ray tube and recovery of yttrium oxide after removing of zinc by precipitation. The final recovery of yttrium is 75–80%.

  7. 29 CFR 37.64 - What procedures must the Director follow when CRC has completed a post-approval compliance review?

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true What procedures must the Director follow when CRC has completed a post-approval compliance review? 37.64 Section 37.64 Labor Office of the Secretary of Labor... (WIA) Compliance Procedures § 37.64 What procedures must the Director follow when CRC has completed a...

  8. 77 FR 27255 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change To...

    Science.gov (United States)

    2012-05-09

    ... Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change To Reduce the Current Level of Risk Mutualization Among Clearing Participants and To Modify the Initial Margin Risk Model So That It Is Easier for... modifications to its risk model for clearing credit default swaps (``CDS'') contracts. For the first...

  9. 75 FR 12590 - Self-Regulatory Organizations; The Chicago Stock Exchange, Inc.; Order Approving a Proposed Rule...

    Science.gov (United States)

    2010-03-16

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61680; File No. SR-CHX-2009-18] Self-Regulatory Organizations; The Chicago Stock Exchange, Inc.; Order Approving a Proposed Rule Change To Amend Its Co-Location Fees March 10, 2010. I. Introduction On December 22, 2009, the Chicago Stock Exchange, Inc. (``CHX'' or...

  10. 76 FR 67238 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change by BATS...

    Science.gov (United States)

    2011-10-31

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65619, File No. SR-BATS-2011-032] Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change by BATS Exchange, Inc. To Adopt Rules Applicable to Auctions Conducted by the Exchange for Exchange-Listed Securities October 25, 2011. I. Introduction On August 22, 2011,...

  11. 75 FR 1438 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule...

    Science.gov (United States)

    2010-01-11

    ...)(iv). Finally, because DMMs no longer act as agent for orders on the Display Book under the rules of... the Policy would not be in violation the Order Display rule \\8\\ and/or the Firm Quote rule \\9\\ under...-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule Change Rescinding...

  12. 75 FR 1439 - Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Rescinding...

    Science.gov (United States)

    2010-01-11

    ...(a)(iv). Finally, because DMMs no longer act as agent for orders on the Display Book under the rules... fails to follow the Policy would not be in violation the Order Display rule \\8\\ and/or the Firm Quote...-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Rescinding NYSE Information...

  13. 75 FR 500 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule...

    Science.gov (United States)

    2010-01-05

    .... 61043 (November 20, 2009), 74 FR 62612. On January 22, 2009, the Commission approved the formation of... wholly-owned subsidiary, NYSE Market, Inc., owns less than 9% of the aggregate limited partnership... proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f). \\12\\ 15 U.S...

  14. Battling Inertia in Educational Leadership: CRT Praxis for Race Conscious Dialogue

    Science.gov (United States)

    Agosto, Vonzell; Karanxha, Zorka; Bellara, Aarti

    2015-01-01

    The purpose of this article is to illustrate how institutional racism is mediated by faculty negotiating power and privilege in the selection of Black (African American) women into an educational leadership preparation program. Critical race theory (CRT) praxis is used to analyze the faculty dynamics in the candidate selection process situated in…

  15. Interaction of Left Ventricular Size and Sex on Outcome of Cardiac Resynchronization Therapy Among Patients With a Narrow QRS Duration in the EchoCRT Trial

    DEFF Research Database (Denmark)

    Varma, Niraj; Sogaard, Peter; Bax, Jeroen J

    2018-01-01

    BACKGROUND: Longer QRS duration (QRSd) improves, but increased left ventricular (LV) end-diastolic volume (LVEDV) reduces, efficacy of cardiac resynchronization therapy (CRT). QRSd/LVEDV ratios differ between sexes. We hypothesized that in the EchoCRT (Echocardiography Guided Cardiac Resynchroniz......BACKGROUND: Longer QRS duration (QRSd) improves, but increased left ventricular (LV) end-diastolic volume (LVEDV) reduces, efficacy of cardiac resynchronization therapy (CRT). QRSd/LVEDV ratios differ between sexes. We hypothesized that in the EchoCRT (Echocardiography Guided Cardiac...... Resynchronization Therapy) trial enrolling patients with heart failure with QRSd New York Heart Association class III, QRSd

  16. 75 FR 80553 - Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Relating to...

    Science.gov (United States)

    2010-12-22

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63558; File No. SR-NYSEAmex-2010-100] Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Relating to Complex Orders December 16, 2010. I. Introduction On October 20, 2010, NYSE Amex LLC (``NYSE Amex'' or the ``Exchange...

  17. COLLABORATIVE RANKING TASKS (CRT BERBANTUAN e-LEARNING UNTUK MENINGKATAN KETERAMPILAN GENERIK SAINS MAHASISWA CALON GURU FISIKA

    Directory of Open Access Journals (Sweden)

    A. F.C. Wijaya

    2012-07-01

    Full Text Available Kurangnya kemampuan mahasiswa dalam proses membangun konsep dan keterampilan generik sains membuat kompetensi mereka tidaklah utuh sebagai calon guru. Collaborative Ranking Tasks (CRT sebagai format baru dari latihan konseptual dan dilakukan secara kolaboratif dan ditunjang multimedia pembelajaran dalam sistem managemen e-Learning diharapkan dapat menjadi solusinya. Penelitian kuasi eksperimen pada 120 mahasiswa perkuliahan IPBA semester genap 2010-2011 yang dipilih secara purposive sampling dan terbagi menjadi dua kelompok kontrol dan eksperimen, penerapan CRT berbantuan e-Learning diarahkan untuk mengetahui pengaruhnya terhadap penguasaan konsep dan keterampilan generik sains (KGS mereka. Dengan menggunakan instrumen pilihan ganda pada kelompok eksperimen dan kontrol, penguasaan konsep dan KGS mahasiswa dianalisis berdasarkan nilai rata-rata gain yang dinormalisasi mereka. Hasil penelitian menunjukkan peningkatan penguasaan konsep pada kelompok eksperimen berbeda secara signifikan dibandingkan dengan peningkatan penguasaan konsep pada kelompok kontrol. Dengan demikian penerapan CRT berbantuan e-learning pada perkuliahan IPBA berpengaruh positif dan signifikan terhadap peningkatan penguasaan konsep dan KGS mahasiswa. Lackof developing mastery concept and generic science skills of physics university students causes them as a prospective physics teacher having incomplete competence. Collaborative Ranking Tasks (CRTas a new form of conceptual exercise that is built collaborativelyby means of multimedia assistance hopefuly becomes the solution.By employing quasi-experimental research method, this study was aimed to investigate the effectiveness of CRT with e-Learning support system to improve university students’ mastery concepts and generic skills. The subjects of the study were 120 university students which were chosen through purposive sampling and divided into experimental group and control group. The research instruments were

  18. Carcinoembryonic antigen (CEA) level, CEA ratio, and treatment outcome of rectal cancer patients receiving pre-operative chemoradiation and surgery

    International Nuclear Information System (INIS)

    Yang, Kai-Lin; Chang, Shih-Ching; Chu, Lee-Shing; Wang, Ling-Wei; Yang, Shung-Haur; Liang, Wen-Yih; Kuo, Ying-Ju; Lin, Jen-Kou; Lin, Tzu-Chen; Chen, Wei-Shone; Jiang, Jeng-Kae; Wang, Huann-Sheng

    2013-01-01

    To investigate serum carcinoembryonic antigen (CEA) as a prognostic factor for rectal cancer patients receiving pre-operative chemoradiotherapy (CRT). Between 2000 and 2009, 138 patients with advanced rectal cancer receiving CRT before surgery at our hospital were retrospectively classified into 3 groups: pre-CRT CEA <6 ng/ml (group L; n = 87); pre-CRT CEA ≥ 6 ng/ml and post-CRT CEA <6 ng/ml (group H-L; n = 32); and both pre- and post-CRT CEA ≥ 6 ng/ml (group H-H; n = 19). CEA ratio (defined as post-CRT CEA divided by pre-CRT CEA), post-CRT CEA level and other factors were reviewed for prediction of pathologic complete response (pCR). Five-year disease-free survival (DFS) was better in groups L (69.0%) and H-L (74.5%) than in group H-H (44.9%) (p = 0.024). Pathologic complete response was observed in 19.5%, 21.9% and 5.3% of groups L, H-L and H-H respectively (p = 0.281). Multivariate analysis showed that ypN stage and pCR were independent prognostic factors for DFS and that post-CRT CEA level was independently predictive of pCR. As a whole, post-CRT CEA <2.61 ng/ml predicted pCR (sensitivity 76.0%; specificity 58.4%). For those with pre-CRT CEA ≥6 ng/ml, post-CRT CEA and CEA ratio both predicted pCR (sensitivity 87.5%, specificity 76.7%). In patients with pre-CRT serum CEA ≥6 ng/ml, those with “normalized” CEA levels after CRT may have similar DFS to those with “normal” (<6 ng/ml) pre-CRT values. Post-CRT CEA level is a predictor for pCR, especially in those with pre-CRT CEA ≥6 ng/ml

  19. Medicaid program; Medicaid Management Information Systems; conditions of approval and reapproval and procedures for reduction of federal financial participation--Health Care Financing Administration. Proposed rule.

    Science.gov (United States)

    1983-03-03

    This proposal adds to regulations new conditions and procedures for initial approval and for reapproval of Medicaid Management Information Systems (MMIS) to update the regulations to reflect additional requirements added by section 901 of the Mental Health Systems Act of 1980 (Pub. L. 96-398). The proposal specifies procedures for reducing the level of Federal financial participation in a State's administrative expenditures when a State fails to meet the conditions for initial operation, initial approval or reapproval of an MMIS. It also proposes procedures with respect to waivers of the conditions of approval and reapproval and to appeals of adverse decisions. These provisions are intended to improve States' MMIS, and to ensure efficient system operations, and to detect cases of fraud, waste, and abuse effectively.

  20. 75 FR 65541 - Self-Regulatory Organizations; Order Approving Proposed Rule Change by NASDAQ OMX PHLX, Inc. To...

    Science.gov (United States)

    2010-10-25

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63132; File No. SR-Phlx-2010-118] Self-Regulatory Organizations; Order Approving Proposed Rule Change by NASDAQ OMX PHLX, Inc. To Expand the $.50 Strike Price Program October 19, 2010. On August 25, 2010, NASDAQ OMX PHLX, Inc. (``Phlx'' or ``Exchange...

  1. 75 FR 38584 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Approving a Proposed Rule Change To...

    Science.gov (United States)

    2010-07-02

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62395; File No. SR-Phlx-2010-18] Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Approving a Proposed Rule Change To Codify Prices for Co-Location Services June 28, 2010. I. Introduction On January 29, 2010, NASDAQ OMX PHLX (``Phlx'' or...

  2. 75 FR 38585 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving a Proposed Rule Change To...

    Science.gov (United States)

    2010-07-02

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62396; File No. SR-BX-2010-012] Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving a Proposed Rule Change To Codify Prices for Co-Location Services June 28, 2010. I. Introduction On January 29, 2010, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange...

  3. 77 FR 42462 - Hawaii State Plan for Occupational Safety and Health; Proposed Modification of 18(e) Plan Approval

    Science.gov (United States)

    2012-07-19

    ... DEPARTMENT OF LABOR Occupational Safety and Health Administration 29 CFR Part 1952 [Docket ID. OSHA 2012-0029] RIN 1218-AC78 Hawaii State Plan for Occupational Safety and Health; Proposed Modification of 18(e) Plan Approval AGENCY: Occupational Safety and Health Administration (OSHA), Department of...

  4. 75 FR 28814 - FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports From FHA Approved Lenders

    Science.gov (United States)

    2010-05-24

    ... proposal. This information is required for: (1) FHA lender approval, (2) Annual renewal of each FHA lender... following information: Title of Proposal: FHA Lender Approval, Annual Renewal, Periodic Updates and Required... and HUD-92001-C. Description of the Need for the Information and Its Proposed Use: This information is...

  5. Performance of the SciBar cosmic ray telescope (SciCRT) toward the detection of high-energy solar neutrons in solar cycle 24

    Science.gov (United States)

    Sasai, Yoshinori; Nagai, Yuya; Itow, Yoshitaka; Matsubara, Yutaka; Sako, Takashi; Lopez, Diego; Itow, Tsukasa; Munakata, Kazuoki; Kato, Chihiro; Kozai, Masayoshi; Miyazaki, Takahiro; Shibata, Shoichi; Oshima, Akitoshi; Kojima, Hiroshi; Tsuchiya, Harufumi; Watanabe, Kyoko; Koi, Tatsumi; Valdés-Galicia, Jose Francisco; González, Luis Xavier; Ortiz, Ernesto; Musalem, Octavio; Hurtado, Alejandro; Garcia, Rocio; Anzorena, Marcos

    2014-12-01

    We plan to observe solar neutrons at Mt. Sierra Negra (4,600 m above sea level) in Mexico using the SciBar detector. This project is named the SciBar Cosmic Ray Telescope (SciCRT). The main aims of the SciCRT project are to observe solar neutrons to study the mechanism of ion acceleration on the surface of the sun and to monitor the anisotropy of galactic cosmic-ray muons. The SciBar detector, a fully active tracker, is composed of 14,848 scintillator bars, whose dimension is 300 cm × 2.5 cm × 1.3 cm. The structure of the detector enables us to obtain the particle trajectory and its total deposited energy. This information is useful for the energy reconstruction of primary neutrons and particle identification. The total volume of the detector is 3.0 m × 3.0 m × 1.7 m. Since this volume is much larger than the solar neutron telescope (SNT) in Mexico, the detection efficiency of the SciCRT for neutrons is highly enhanced. We performed the calibration of the SciCRT at Instituto Nacional de Astrofisica, Optica y Electronica (INAOE) located at 2,150 m above sea level in Mexico in 2012. We installed the SciCRT at Mt. Sierra Negra in April 2013 and calibrated this detector in May and August 2013. We started continuous observation in March 2014. In this paper, we report the detector performance as a solar neutron telescope and the current status of the SciCRT.

  6. A Variant PfCRT Isoform Can Contribute to Plasmodium falciparum Resistance to the First-Line Partner Drug Piperaquine

    Directory of Open Access Journals (Sweden)

    Satish K. Dhingra

    2017-05-01

    Full Text Available Current efforts to reduce the global burden of malaria are threatened by the rapid spread throughout Asia of Plasmodium falciparum resistance to artemisinin-based combination therapies, which includes increasing rates of clinical failure with dihydroartemisinin plus piperaquine (PPQ in Cambodia. Using zinc finger nuclease-based gene editing, we report that addition of the C101F mutation to the chloroquine (CQ resistance-conferring PfCRT Dd2 isoform common to Asia can confer PPQ resistance to cultured parasites. Resistance was demonstrated as significantly higher PPQ concentrations causing 90% inhibition of parasite growth (IC90 or 50% parasite killing (50% lethal dose [LD50]. This mutation also reversed Dd2-mediated CQ resistance, sensitized parasites to amodiaquine, quinine, and artemisinin, and conferred amantadine and blasticidin resistance. Using heme fractionation assays, we demonstrate that PPQ causes a buildup of reactive free heme and inhibits the formation of chemically inert hemozoin crystals. Our data evoke inhibition of heme detoxification in the parasite’s acidic digestive vacuole as the primary mode of both the bis-aminoquinoline PPQ and the related 4-aminoquinoline CQ. Both drugs also inhibit hemoglobin proteolysis at elevated concentrations, suggesting an additional mode of action. Isogenic lines differing in their pfmdr1 copy number showed equivalent PPQ susceptibilities. We propose that mutations in PfCRT could contribute to a multifactorial basis of PPQ resistance in field isolates.

  7. Immunotherapy Combination Approved for Advanced Kidney Cancer

    Science.gov (United States)

    FDA has approved the combination of the immunotherapy drugs nivolumab (Opdivo) and ipilimumab (Yervoy) as an initial treatment for some patients with advanced kidney cancer. The approval is expected to immediately affect patient care, as this Cancer Currents post explains.

  8. Evaluation of individual cognitive remediation therapy (CRT) for the treatment of young people with anorexia nervosa.

    Science.gov (United States)

    Giombini, Lucia; Moynihan, Jennifer; Turco, Matteo; Nesbitt, Sophie

    2017-12-01

    Research suggests that there are cognitive inefficiencies underlying Anorexia Nervosa (AN), with CRT showing promise in improving these inefficiencies in adults. This area has yet to be explored in a younger population. The aim of this study was to evaluate the use of CRT for young people. A within-subjects design was used to compare the performance of children and adolescents with AN on several neuropsychological measures administered before and after a course of CRT. Ninety-two female participants diagnosed with AN aged between 11 and 17 (M = 14.8, SD = 1.6), all receiving treatment at a specialist inpatient unit. The assessment consisted of the Rey-Osterrieth Complex Figure test (ROCFT), the Behaviour Rating Inventory of Executive Function-Self-Report (BRIEF-SR), and the D-KEFS Colour-Word Interference Test (CWT). Repeated-measures t tests were used to analyse the ROCFT and BRIEF-SR data. There was a significant improvement in Central Coherence Index (p < .001), Immediate Recall (p < .001), Shift (p < .001) Cognitive Shift (p = 002), Behavioural shift (p < .001), Emotional Control (p < .001), Working Memory (p = .001), Plan/Organize (p < .001), Monitor (p = .001) BRI (p < .001), MI (p = .001), and GEC (p < .001). On the D-KEFS CWT, a repeated-measure Wilcoxon signed-rank test revealed a significant improvement in Error Rate (p = .019) and a repeated-measures t test revealed a significant improvement in time taken (p < .001). Results suggest that CRT for children and adolescents with AN could strengthen specific cognitive domains.

  9. Immediate electrical storm of Torsades de Pointes after CRT-D implantation in an ischemic cardiomyopathy patient

    Directory of Open Access Journals (Sweden)

    Adnan Kaya, MD

    2015-06-01

    Full Text Available Cardiac resynchronization therapy with an implantable cardioverter-defibrillator (CRT-D is the preferred treatment for patients with severe heart failure, dyssynchrony, and an increased risk of sudden cardiac death or for primary ventricular arrhythmia survivors. Rarely, left ventricular epicardial pacing can induce ventricular tachyarrhythmia rather than a beneficial effect. We describe an ischemic cardiomyopathy patient who underwent CRT-D therapy and developed sustained torsades de pointes (TdP immediately after switching to biventricular pacing (BVP mode. Here, TdP possibly developed owing to the change in the dispersion of repolarization of the left ventricle myocardium. The diagnosis and management of BVP-induced ventricular arrhythmia is discussed.

  10. Overexpression of CrtR-b2 (carotene beta hydroxylase 2) from S. lycopersicum L. differentially affects xanthophyll synthesis and accumulation in transgenic tomato plants.

    Science.gov (United States)

    D'Ambrosio, Caterina; Stigliani, Adriana Lucia; Giorio, Giovanni

    2011-02-01

    Plant chloroplasts are enriched in xanthophylls which participate in photosynthesis as light-absorbing pigments and as dissipaters of excess light. In comparison, chromoplasts have evolved the capacity to synthesize and store brightly coloured carotenoid pigments to give flowers and fruits the power to attract pollinators and fruit dispersers. The best performing accumulator of xanthophylls in tomato is the petal chromoplast in contrast to the fruit chromoplast which only seems able to store carotenes. We have generated genetically engineered tomato lines carrying the tomato CrtR-b2 transgene with the aim of forcing the fruit to accumulate beta-xanthophylls. Both chloroplast- and chromoplast-containing tissues of hemizygous transgenic plants were found to contain elevated xanthophyll contents as a direct consequence of the increased number of CrtR-b2 transcripts. Hemizygous transgenic leaves contained fourfold more violaxanthin than control leaves. Developing fruits were yellow instead of green since they lacked chlorophyll a, and their violaxanthin and neoxanthin contents were seven- and threefold higher, respectively, than those of the control. Ripe fruits of hemizygous transgenic plants contained free violaxanthin and significant amounts of esterified xanthophylls. Esterified xanthophylls were present also in ripe fruits of control and homozygous plants. However, in transgenic homozygous plants, we observed a reduction in transcript content in most tissues, particularly in petals, due to a post-transcriptional gene silencing process. These findings demonstrate that tomato fruit chromoplasts can accumulate xanthophylls with the same sequestration mechanism (esterification) as that exploited by chromoplasts of the tomato petal and pepper fruit. This study on transgenic plants overexpressing an important carotenoid gene (CrtR-b2) provides an interesting model for future investigations on perturbations in beta-carotene-derived xanthophyll synthesis which in turn may

  11. Prognostic Role of Carcinoembryonic Antigen Level after Preoperative Chemoradiotherapy in Patients with Rectal Cancer.

    Science.gov (United States)

    Huh, Jung Wook; Yun, Seong Hyeon; Kim, Seok Hyung; Park, Yoon Ah; Cho, Yong Beom; Kim, Hee Cheol; Lee, Woo Yong; Park, Hee Chul; Choi, Doo Ho; Park, Joon Oh; Park, Young Suk; Chun, Ho-Kyung

    2018-05-29

    The prognostic role of post-chemoradiotherapy (CRT) carcinoembryonic antigen (CEA) level is not clear. We evaluated the prognostic significance of post-CRT CEA level in patients with rectal cancer after preoperative CRT. We reviewed 659 consecutive patients who underwent preoperative CRT and total mesorectal excision for non-metastatic rectal cancer. Patients were categorized into two groups according to post-CRT serum CEA level: low CEA (level was 1.7 ng/mL (range, 0.1-207.0). A high post-CRT level was significantly associated with ypStage, ypT category, tumor regression grade, and pre-CRT CEA level. The 5-year overall survival rate of the 659 patients was 87.8% with a median follow-up period of 57.0 months (range, 1.4-176.4). When the post-CRT CEA groups were divided into groups according to pre-CRT CEA level, the 5-year overall survival rates were significantly different (P level was an independent prognostic factor for overall survival. Multivariate analysis revealed that operation method, differentiation, perineural invasion, postoperative chemotherapy, tumor regression grade, and post-CRT CEA level were independent prognostic factors for overall survival. The level of serum CEA after preoperative CRT was an independent prognostic factor for overall survival in patients with rectal cancer.

  12. Complications After Sphincter-Saving Resection in Rectal Cancer Patients According to Whether Chemoradiotherapy Is Performed Before or After Surgery

    International Nuclear Information System (INIS)

    Kim, Chan Wook; Kim, Jong Hoon; Yu, Chang Sik; Shin, Ui Sup; Park, Jin Seok; Jung, Kwang Yong; Kim, Tae Won; Yoon, Sang Nam; Lim, Seok-Byung; Kim, Jin Cheon

    2010-01-01

    Purpose: The aim of the present study was to compare the influence of preoperative chemoradiotherapy (CRT) with postoperative CRT on the incidence and types of postoperative complications in rectal cancer patients who underwent sphincter-saving resection. Patients and Methods: We reviewed 285 patients who received preoperative CRT and 418 patients who received postoperative CRT between January 2000 and December 2006. Results: There was no between-group difference in age, gender, or cancer stage. In the pre-CRT group, the mean level of anastomosis from the anal verge was lower (3.5 ± 1.4 cm vs. 4.3 ± 1.7 cm, p < 0.001) and the rate of T4 lesion and temporary diverting ileostomy was higher than in the post-CRT group. Delayed anastomotic leakage and rectovaginal fistulae developed more frequently in the pre-CRT group than in the post-CRT group (3.9% vs. 1.2%, p = 0.020, 6.5% vs. 1.3%, p = 0.027, respectively). Small bowel obstruction (arising from radiation enteritis) requiring surgical intervention was more frequent in the post-CRT group (0% in the pre-CRT group vs. 1.4% in the post-CRT group, p = 0.042). Multivariate analysis identified preoperative CRT as an independent risk factor for fistulous complications (delayed anastomotic leakage, rectovaginal fistula, rectovesical fistula), and postoperative CRT as a risk factor for obstructive complications (anastomotic stricture, small bowel obstruction). The stoma-free rates were significantly lower in the pre-CRT group than in the post-CRT group (5-year stoma-free rates: 92.8% vs. 97.0%, p = 0.008). Conclusion: The overall postoperative complication rates were similar between the pre-CRT and the Post-CRT groups. However, the pattern of postoperative complications seen after sphincter- saving resection differed with reference to the timing of CRT.

  13. A dosimetric comparison of 3D-CRT, IMRT, and static tomotherapy with an SIB for large and small breast volumes

    Energy Technology Data Exchange (ETDEWEB)

    Michalski, Andrea [Department of Health Science (MRS), The University of Sydney, Lidcombe, New South Wales (Australia); Central Coast Cancer Centre, Gosford Hospital, Gosford, New South Wales (Australia); Atyeo, John, E-mail: john.atyeo@sydney.edu.au [Department of Health Science (MRS), The University of Sydney, Lidcombe, New South Wales (Australia); Cox, Jennifer [Department of Health Science (MRS), The University of Sydney, Lidcombe, New South Wales (Australia); Department of Radiation Oncology, Royal North Shore Hospital, St Leonards, New South Wales (Australia); Rinks, Marianne [Department of Health Science (MRS), The University of Sydney, Lidcombe, New South Wales (Australia); Radiation Oncology, Cancer Services, Illawarra Shoalhaven Local Health District, Wollongong, New South Wales (Australia); Morgia, Marita; Lamoury, Gillian [Department of Radiation Oncology, Royal North Shore Hospital, St Leonards, New South Wales (Australia)

    2014-07-01

    Radiation therapy to the breast is a complex task, with many different techniques that can be employed to ensure adequate dose target coverage while minimizing doses to the organs at risk. This study compares the dose planning outcomes of 3 radiation treatment modalities, 3 dimensional conformal radiation therapy (3D-CRT), intensity-modulated radiation therapy (IMRT), and static tomotherapy, for left-sided whole-breast radiation treatment with a simultaneous integrated boost (SIB). Overall, 20 patients with left-sided breast cancer were separated into 2 cohorts, small and large, based on breast volume. Dose plans were produced for each patient using 3D-CRT, IMRT, and static tomotherapy. All patients were prescribed a dose of 45 Gy in 20 fractions to the breast with an SIB of 56 Gy in 20 fractions to the tumor bed and normalized so that D{sub 98%} > 95% of the prescription dose. Dosimetric comparisons were made between the 3 modalities and the interaction of patient size. All 3 modalities offered adequate planning target volume (PTV) coverage with D{sub 98%} > 95% and D{sub 2%} < 107%. Static tomotherapy offered significantly improved (p = 0.006) dose homogeneity to the PTV{sub boost} {sub eval} (0.079 ± 0.011) and breast minus the SIB volume (Breast{sub SIB}) (p < 0.001, 0.15 ± 0.03) compared with the PTV{sub boost} {sub eval} (0.085 ± 0.008, 0.088 ± 0.12) and Breast{sub SIB} (0.22 ± 0.05, 0.23 ± 0.03) for IMRT and 3D-CRT, respectively. Static tomotherapy also offered statistically significant reductions (p < 0.001) in doses to the ipsilateral lung mean dose of 6.79 ± 2.11 Gy compared with 7.75 ± 2.54 Gy and 8.29 ± 2.76 Gy for IMRT and 3D-CRT, respectively, and significantly (p < 0.001) reduced heart doses (mean = 2.83 ± 1.26 Gy) compared to both IMRT and 3D-CRT (mean = 3.70 ± 1.44 Gy and 3.91 ± 1.58 Gy). Static tomotherapy is the dosimetrically superior modality for the whole breast with an SIB compared with IMRT and 3D-CRT. IMRT is superior to 3D-CRT

  14. Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical data

    Directory of Open Access Journals (Sweden)

    Strech Daniel

    2012-07-01

    Full Text Available Abstract For the protection of commercial interests, licensing bodies such as the EMA and health technology assessment institutions such as NICE restrict full access to unpublished evidence. Their respective policies on data transparency, however, lack a systematic account of (1 what kinds of commercial interests remain relevant after market approval has been granted, (2 what the specific types of public interest are that may override these commercial interests post approval, and, most importantly, (3 what criteria guide the trade-off between public interest and legitimate measures for the protection of commercial interest. Comparing potential commercial interests with seven specifications of relevant public interest reveals the lack of proportionality inherent in the current practices of EMA and NICE.

  15. Perspectives used for gaining approval of budgets.

    Science.gov (United States)

    Franks-Joiner, G L

    1990-01-01

    Nurse executives think about problems using a certain perspective which may influence decisions on budgetary matters. The nurse executives' perspective used in decision-making may influence which budget proposals are developed and approved. A study was performed to determine the perspective used by nurse executives in decision-making on supplementary budget item proposals and whether perspective use influenced approval. Findings showed that use of the system view or dual-domain perspective in a proposal may enhance nurse executives' changes of gaining approval.

  16. Lead recovery and glass microspheres synthesis from waste CRT funnel glasses through carbon thermal reduction enhanced acid leaching process.

    Science.gov (United States)

    Mingfei, Xing; Yaping, Wang; Jun, Li; Hua, Xu

    2016-03-15

    In this study, a novel process for detoxification and reutilization of waste cathode ray tube (CRT) funnel glass was developed by carbon thermal reduction enhanced acid leaching process. The key to this process is removal of lead from the CRT funnel glass and synchronous preparation of glass microspheres. Carbon powder was used as an isolation agent and a reducing agent. Under the isolation of the carbon powder, the funnel glass powder was sintered into glass microspheres. In thermal reduction, PbO in the funnel glass was first reduced to elemental Pb by carbon monoxide and then located on the surface of glass microspheres which can be removed easily by acid leaching. Experimental results showed that temperature, carbon adding amount and holding time were the major parameters that controlled lead removal rate. The maximum lead removal rate was 94.80% and glass microspheres that measured 0.73-14.74μm were obtained successfully by setting the temperature, carbon adding amount and holding time at 1200°C, 10% and 30min, respectively. The prepared glass microspheres may be used as fillers in polymer materials and abrasive materials, among others. Accordingly, this study proposed a practical and economical process for detoxification and recycling of waste lead-containing glass. Copyright © 2015 Elsevier B.V. All rights reserved.

  17. Impact of the right ventricular lead position on clinical outcome and on the incidence of ventricular tachyarrhythmias in patients with CRT-D

    DEFF Research Database (Denmark)

    Kutyifa, Valentina; Bloch Thomsen, Poul Erik; Huang, David T.

    2013-01-01

    Data on the impact of right ventricular (RV) lead location on clinical outcome and ventricular tachyarrhythmias in cardiac resynchronization therapy with defibrillator (CRT-D) patients are limited.......Data on the impact of right ventricular (RV) lead location on clinical outcome and ventricular tachyarrhythmias in cardiac resynchronization therapy with defibrillator (CRT-D) patients are limited....

  18. Exposure to hazardous substances in Cathode Ray Tube (CRT) recycling sites in France

    Energy Technology Data Exchange (ETDEWEB)

    Lecler, Marie-Thérèse, E-mail: marie-therese.lecler@inrs.fr; Zimmermann, François; Silvente, Eric; Clerc, Frédéric; Chollot, Alain; Grosjean, Jérôme

    2015-05-15

    Highlights: • Chemical risks were assessed in the nine cathode ray tube screens recycling facilities. • The main hazardous agents are dust containing lead, cadmium, barium and yttrium. • Exposure and pollutant levels are described for different operations and processes. • All the operations and processes are concerned by significant levels of pollutants. • We suggest recommendations to reduce chemical risk. - Abstract: The Waste Electrical and Electronic Equipment (WEEE) or e-waste recycling sector has grown considerably in the last fifteen years due to the ever shorter life cycles of consumables and an increasingly restrictive policy context. Cathode Ray Tubes (CRTs) from used television and computer screens represent one of the main sources of e-waste. CRTs contain toxic materials such as lead, cadmium, barium, and fluorescent powders which can be released if recycling of CRTs is not appropriate. Exposure to these harmful substances was assessed in nine workshops where CRT screens are treated. Particulate exposure levels were measured using a gravimetric method and metals were analysed by plasma emission spectrometry. The maximum levels of worker exposure were 8.8 mg/m{sup 3}, 1504.3 μg/m{sup 3}, 434.9 μg/m{sup 3}, 576.3 μg/m{sup 3} and 2894.3 μg/m{sup 3} respectively for inhalable dust, barium, cadmium, lead and yttrium. The maximum levels of airborne pollutants in static samples were 39.0 mg/m{sup 3}, 848.2 μg/m{sup 3}, 698.4 μg/m{sup 3}, 549.3 μg/m{sup 3} and 3437.9 μg/m{sup 3} for inhalable dust, barium, cadmium, lead and yttrium. The most harmful operations were identified, and preventive measures for reducing the chemical risk associated with screen recycling were proposed. Workplace measurements were used to define recommendations for reducing the chemical risks in CRT screens recycling facilities and for promoting the design and development of “clean and safe” processes in emerging recycling channels.

  19. Plant automation and CRT display system for nuclear power plants

    International Nuclear Information System (INIS)

    Tekiguchi, S.; Sukai, K.; Watanabe, N.; Yamasaki, M.

    1987-01-01

    The reliability of plant operation is greatly improved by utilizing selected data for display in real-time on the screens of 12 color CRTs in the Central Control Room and voice information. The load on operators is reduced by automated operation of plant equipment and an operation guide. Information from the power station is transmitted to an off-site location via an optical fiber data way which makes it possible to display in real-time the same CRT screens displayed in the Central Control Room

  20. The Fast Intelligent Tracking (F!T) tube: A CRT without a shadow mask

    NARCIS (Netherlands)

    Bergman, A.H.; Brink, van den H.B.; Budzelaar, F.P.M.; Engelaar, P.J.; Holtslag, A.H.M.; IJzerman, W.L.; Krijn, M.P.C.M.; Lieshout, van P.J.G.; Notari, A.; Willemsen, O.H.

    2003-01-01

    The F!T tube is a new type of CRT without a shadow mask. The primary function of the mask, color selection, is taken over by an electronic control system that guides the electron beams over the correct phosphor lines. The position of the beams is detected by means of dedicated structures on the

  1. Human engineering evaluation of Hamaoka No. 3 advanced control room CRT display system

    International Nuclear Information System (INIS)

    Okajima, Hiroyuki; Ito, Takahiko; Noguchi, Yoshihiro; Kabasawa, Yoshihiko

    1985-01-01

    As the central control board of Hamaoka No. 3 plant, a new type control board was adopted for the purpose of powerfully supporting the general judgement function of operators by processing enormous plant data in the normal operation and at the time of an accident with a computer, and displaying the results on CRT screens in the summarized form. Recently, the evaluation of this new control board was carried out by ergonomical techniques, and it was confirmed that the initial objective has been attained. Besides, the criteria for the ergonomical evaluation of central control boards mainly for CRT display were determined, and the contents of design were able to be systematically evaluated and verified. As the ergonomical design of the central control board, the easy distinction of the function of switches, the easy confirmation of system constitution by mimics, the use of CRTs, the easy identification of operation pilot lamps, alarms, instruments and so on were considered. The central control board consists of the main control board, auxiliary control boards and vertical boards, and 12 CRTs are installed. (Kako, I.)

  2. Procedure for image acquisition and dosimetric planning for prostate cancer with 3D-CRT in the MIRS 3.0

    International Nuclear Information System (INIS)

    Perez Velasquez, Reytel; Alvarez Zaldivar, Junior; Gonzalez Lopez, Nadia

    2009-01-01

    For over 30 years in the department of Radiotherapy of the Lenin Hospital has been doing conventional radiotherapy. In this paper we describe the dose planning procedure for patients with prostate cancer with 3D-CRT in the MIRS RTPS 3.0. The work ranges from imaging in the TAC including quality control of this, the definition of bodies radio therapists medical risk to the data to be transferred to processing machine. With this procedure we have established guidelines for planning 3D-CRT treatments for other locations. (author)

  3. A faster and more reliable data acquisition system for the full performance of the SciCRT

    International Nuclear Information System (INIS)

    Sasai, Y.; Matsubara, Y.; Itow, Y.; Sako, T.; Kawabata, T.; Lopez, D.; Hikimochi, R.; Tsuchiya, A.; Ikeno, M.; Uchida, T.; Tanaka, M.; Munakata, K.; Kato, C.; Nakamura, Y.; Oshima, T.; Koike, T.; Kozai, M.; Shibata, S.; Oshima, A.; Takamaru, H.

    2017-01-01

    The SciBar Cosmic Ray Telescope (SciCRT) is a massive scintillator tracker to observe cosmic rays at a very high-altitude environment in Mexico. The fully active tracker is based on the Scintillator Bar (SciBar) detector developed as a near detector for the KEK-to-Kamioka long-baseline neutrino oscillation experiment (K2K) in Japan. Since the data acquisition (DAQ) system was developed for the accelerator experiment, we determined to develop a new robust DAQ system to optimize it to our cosmic-ray experiment needs at the top of Mt. Sierra Negra (4600 m). One of our special requirements is to achieve a 10 times faster readout rate. We started to develop a new fast readout back-end board (BEB) based on 100 Mbps SiTCP, a hardware network processor developed for DAQ systems for high energy physics experiments. Then we developed the new BEB which has a potential of 20 times faster than the current one in the case of observing neutrons. Finally we installed the new DAQ system including the new BEBs to a part of the SciCRT in July 2015. The system has been operating since then. In this paper, we describe the development, the basic performance of the new BEB, the status after the installation in the SciCRT, and the future performance.

  4. A faster and more reliable data acquisition system for the full performance of the SciCRT

    Energy Technology Data Exchange (ETDEWEB)

    Sasai, Y., E-mail: sasaiyoshinori@isee.nagoya-u.ac.jp [Institute for Space-Earth Environmental Research, Nagoya University, Furo-cho, Chikusa-ku, Nagoya 464-8601 (Japan); Matsubara, Y.; Itow, Y.; Sako, T.; Kawabata, T.; Lopez, D.; Hikimochi, R.; Tsuchiya, A. [Institute for Space-Earth Environmental Research, Nagoya University, Furo-cho, Chikusa-ku, Nagoya 464-8601 (Japan); Ikeno, M.; Uchida, T.; Tanaka, M. [High Energy Accelerator Research Organization, KEK, 1-1 Oho, Tsukuba, Ibaraki 305-0801 (Japan); Munakata, K.; Kato, C.; Nakamura, Y.; Oshima, T.; Koike, T. [Department of Physics, Shinshu University, Asahi, Matsumoto 390-8621 (Japan); Kozai, M. [Institute of Space and Astronautical Science, Japan Aerospace Exploration Agency (ISAS/JAXA), Sagamihara, Kanagawa 252-5210 (Japan); Shibata, S.; Oshima, A.; Takamaru, H. [College of Engineering, Chubu University, Kasugai 487-8501 (Japan); and others

    2017-06-11

    The SciBar Cosmic Ray Telescope (SciCRT) is a massive scintillator tracker to observe cosmic rays at a very high-altitude environment in Mexico. The fully active tracker is based on the Scintillator Bar (SciBar) detector developed as a near detector for the KEK-to-Kamioka long-baseline neutrino oscillation experiment (K2K) in Japan. Since the data acquisition (DAQ) system was developed for the accelerator experiment, we determined to develop a new robust DAQ system to optimize it to our cosmic-ray experiment needs at the top of Mt. Sierra Negra (4600 m). One of our special requirements is to achieve a 10 times faster readout rate. We started to develop a new fast readout back-end board (BEB) based on 100 Mbps SiTCP, a hardware network processor developed for DAQ systems for high energy physics experiments. Then we developed the new BEB which has a potential of 20 times faster than the current one in the case of observing neutrons. Finally we installed the new DAQ system including the new BEBs to a part of the SciCRT in July 2015. The system has been operating since then. In this paper, we describe the development, the basic performance of the new BEB, the status after the installation in the SciCRT, and the future performance.

  5. Dabrafenib Plus Trametinib Approved for Melanoma, Thyroid Cancer

    Science.gov (United States)

    FDA recently approved the combination of dabrafenib (Taflinar) and trametinib (Mekinist) to treat some patients with melanoma and anaplastic thyroid cancer whose tumors have a mutation in the BRAF gene. As this Cancer Currents blog post explains, this is the first treatment approved specifically for anaplastic thyroid

  6. Medicare's post-acute care payment: a review of the issues and policy proposals.

    Science.gov (United States)

    Linehan, Kathryn

    2012-12-07

    Medicare spending on post-acute care provided by skilled nursing facility providers, home health providers, inpatient rehabilitation facility providers, and long-term care hospitals has grown rapidly in the past several years. The Medicare Payment Advisory Commission and others have noted several long-standing problems with the payment systems for post-acute care and have suggested refinements to Medicare's post-acute care payment systems that are intended to encourage the delivery of appropriate care in the right setting for a patient's condition. The Patient Protection and Affordable Care Act of 2010 contained several provisions that affect the Medicare program's post-acute care payment systems and also includes broader payment reforms, such as bundled payment models. This issue brief describes Medicare's payment systems for post-acute care providers, evidence of problems that have been identified with the payment systems, and policies that have been proposed or enacted to remedy those problems.

  7. Evaluation of dose coverage to target volume and normal tissue sparing in the adjuvant radiotherapy of gastric cancers: 3D-CRT compared with dynamic IMRT.

    Science.gov (United States)

    Murthy, Kk; Shukeili, Ka; Kumar, Ss; Davis, Ca; Chandran, Rr; Namrata, S

    2010-01-01

    To assess the potential advantage of intensity-modulated radiotherapy (IMRT) over 3D-conformal radiotherapy (3D-CRT) planning in postoperative adjuvant radiotherapy for patients with gastric carcinoma. In a retrospective study, for plan comparison, dose distribution was recalculated in 15 patients treated with 3D-CRT on the contoured structures of same CT images using an IMRT technique. 3D-conformal plans with three fields and four-fields were compared with seven-field dynamic IMRT plans. The different plans were compared by analyzing the dose coverage of planning target volume using TV(95), D(mean), uniformity index, conformity index and homogeneity index parameters. To assess critical organ sparing, D(mean), D(max), dose to one-third and two-third volumes of the OARs and percentage of volumes receiving more than their tolerance doses were compared. The average dose coverage values of PTV with 3F-CRT and 4F-CRT plans were comparable, where as IMRT plans achieved better target coverage(p3D-CRT plans. The doses to the liver and bowel reduced significantly (p3D-CRT plans. For all OARs the percentage of volumes receiving more than their tolerance doses were reduced with the IMRT plans. This study showed that a better target coverage and significant dose reduction to OARs could be achieved with the IMRT plans. The IMRT can be preferred with caution for organ motion. The authors are currently studying organ motion in the upper abdomen to use IMRT for patient treatment.

  8. Executive function needs to be targeted to improve social functioning with Cognitive Remediation Therapy (CRT) in schizophrenia.

    Science.gov (United States)

    Penadés, Rafael; Catalán, Rosa; Puig, Olga; Masana, Guillem; Pujol, Núria; Navarro, Víctor; Guarch, Joana; Gastó, Cristóbal

    2010-05-15

    While the role of impaired cognition in accounting for functional outcome in schizophrenia is generally established, the relationship between cognitive and functional change in the context of treatments is far from clear. The current paper tries to identify which cognitive changes lead to improvements in daily functioning among persons with chronic schizophrenia who had current negative symptoms and evidenced neuropsychological impairments. In a previous work, Cognitive Remediation Therapy (CRT) was compared with a control therapy, involving similar length of therapist contact but different targets. At the end of treatment, CRT conferred a benefit to people with schizophrenia in cognition and functioning [Schizophrenia Research, 87 (2006) 323-331]. Subsequently, analyses of covariance (ANCOVA) were conducted with baseline and cognitive change scores as covariates to test whether cognitive change predicted change in functioning. Additionally, statistical tests to establish the mediation path with significant variables were performed. Although verbal memory, but not executive functioning, was associated with functioning at baseline, it was the improvement in executive functioning that predicted improved daily functioning. Verbal memory played a mediator role in the change process. Consequently, in order to improve daily functioning with CRT, executive function still needs to be targeted in despite of multiple cognitive impairments being present. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

  9. The assessment of local response using magnetic resonance imaging at 3- and 6-month post chemoradiotherapy in patients with anal cancer

    Energy Technology Data Exchange (ETDEWEB)

    Kochhar, Rohit [The Christie NHS Foundation Trust, Department of Radiology, Manchester (United Kingdom); The University of Manchester, Manchester Academic Health Science Centre, Institute of Cancer Sciences, Manchester (United Kingdom); Renehan, Andrew G. [The University of Manchester, Manchester Academic Health Science Centre, Institute of Cancer Sciences, Manchester (United Kingdom); The Christie NHS Foundation Trust, Department of Surgery, Manchester (United Kingdom); Mullan, Damian; Carrington, Bernadette M. [The Christie NHS Foundation Trust, Department of Radiology, Manchester (United Kingdom); Chakrabarty, Bipasha [The Christie NHS Foundation Trust, Department of Histopathology, Manchester (United Kingdom); Saunders, Mark P. [The Christie NHS Foundation Trust, Department of Clinical Oncology, Manchester (United Kingdom)

    2017-02-15

    To assess the use of MRI-determined tumour regression grading (TRG) in local response assessment and detection of salvageable early local relapse after chemoradiotherapy (CRT) in patients with anal squamous cell carcinoma (ASCC). From a prospective database of patients with ASCC managed through a centralised multidisciplinary team, 74 patients who completed routine post-CRT 3- and 6-month MRIs (2009-2012) were reviewed. Two radiologists blinded to the outcomes consensus read and retrospectively assigned TRG scores [1 (complete response) to 5 (no response)] and related these to early local relapse (within 12 months) and disease-free survival (DFS). Seven patients had early local relapse. TRG 1/2 scores at 3 and 6 months had a 100 % negative predictive value; TRG 4/5 scores at 6 months had a 100 % positive predictive value. All seven patients underwent salvage R0 resections. We identified a novel 'tram-track' sign on MRI in over half of patients, with an NPV for early local relapse of 83 % at 6 months. No imaging characteristic or TRG score independently prognosticated for late relapse or 3-year DFS. Post-CRT 3- and 6-month MRI-determined TRG scores predicted salvageable R0 early local relapses in patients with ASCC, challenging current clinical guidelines. (orig.)

  10. Device for correction of the spot dimensions and its form in the measuring CRT of the MELAS automatic unit

    International Nuclear Information System (INIS)

    Kachnova, O.A.; Kryutchenko, E.V.; Utochkin, B.A.; Fedotov, V.S.

    1979-01-01

    A digital-to-analog converter is described, designed for dynamic correction of beam focusing of the measuring cathode-ray tube (CRT) of the MELAS automatic device. The described converter consists of two identical units. Every unit generates a voltage proportional to square of deviations along the X and Y axes. Output voltages of both channels are summarized by an analog adder, transformed into current and are fed to the focusing system. The computer circuit used to correct the dimensions of the CRT beam uses microcircuits with low and medium levels of integration and has the following characteristics: the maximum correcting current is 12.4 mA, the direct component of the focusing current is 0.24 A, the correcting current instability is 0.08% and the reduced temperature instability of the total focusing current is 0.004%. The employment of the converter to correct the dimension and shape of the CRT spot makes it possible to reduce the spot diameter to 18 μm at the center of the face and 22 μm at the edges of the face operating field

  11. 40 CFR 123.61 - Approval process.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Approval process. 123.61 Section 123... REQUIREMENTS Program Approval, Revision, and Withdrawal § 123.61 Approval process. (a) After determining that a...; and (6) Briefly outline the fundamental aspects of the State's proposed program, and the process for...

  12. A holistic approach to recycling of CRT glass and PCBs in Vietnam

    OpenAIRE

    Wiesmeth, Hans; Häckl , Dennis; Do, Quang Trung; Bui, Duy Cam

    2012-01-01

    Rapidly growing quantities of e-waste (WEEE) demand the increasing attention of environmental policy all over the world. Developing countries are particularly affected by recycling and disposal activities, which are deemed harmful to health and environment. Holistic or integrated approaches to WEEE policy are required. The paper discusses first recycling technologies for glass from cathode ray tubes (CRT) and printed circuit boards (PCBs) in Vietnam. Thereafter the German approach to WEEE ...

  13. 29 CFR 1952.10 - Requirements for approval of State posters.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Requirements for approval of State posters. 1952.10 Section... and Conditions § 1952.10 Requirements for approval of State posters. (a)(1) In order to inform..., States with approved plans shall develop and require employers to post a State poster meeting the...

  14. Importance of protocol target definition on the ability to spare normal tissue: An IMRT and 3D-CRT planning comparison for intraorbital tumors

    International Nuclear Information System (INIS)

    Hein, Patrick A.; Gladstone, David J.; Bellerive, Marc R.; Hug, Eugen B.

    2005-01-01

    Purpose: We selected five intraorbital tumor sites that are frequently found in clinical practice in children diagnosed with orbital rhabdomyosarcoma and performed three-dimensional conformal radiotherapy (3D-CRT) and intensity-modulated photon radiotherapy (IMRT) planning. Results of target coverage and doses to critical structures were compared. The goal of this study was to evaluate and to document realistic expectations as to organ-sparing capabilities of modern radiation therapy planning technologies with a focus on lens-sparing irradiation. Furthermore, we investigated potential added benefits of IMRT compared with 3D-CRT and the influence of protocol volume criteria definitions on the ability to obtain normal tissue dose sparing using the orbit as an example of a complex anatomic site. Methods and Materials: The five intraorbital tumor sites were placed retrobulbar, temporal, nasal, in the upper inner and upper outer quadrant, the latter two more complex in shape. Gross tumor volume (GTV), clinical target volume (CTV), and planning target volume (PTV) were defined in image-fused computed tomography and magnetic resonance data sets. 3D-CRT and IMRT photon plans, using equal beam angles and collimation for direct comparison, were designed to 45 Gy prescription dose according to Intergroup Rhabdomyosarcoma Study Group-D9602 (IRSG-D9602) protocol (Intergroup Rhabdomyosarcoma Study V [IRS-V] protocol) for Stage I, Clinical Group 3 orbital rhabdomyosarcoma. To compare the impact of changed target definitions in IMRT planning, additional IMRT plans were generated using modified volume and dose coverage criteria. The minimum dose constraint (95%) of the PTV was substituted by a required minimum volume coverage (95%) with the prescribed dose. Dose-volume histograms (DVHs) were obtained, including target volumes, lens, optic nerves, optic chiasm, lacrimal gland, bony orbit, pituitary gland, frontal and temporal lobes. Results: Protocol target volume coverage criteria

  15. Procedure for image acquisition and dose planning of prostate cancer with 3D-CRT in the MIRS 3.0

    International Nuclear Information System (INIS)

    Perez Velasquez, Reytel; Alvarez Zaldivar, Junior; Gonzalez Lopez, Nadia

    2009-01-01

    For over 30 years in the department of Radiotherapy of the Lenin Hospital has been making conventional radiotherapy. In the present work is presented the procedure for dosimetric planning of patients with prostate cancer with 3D-CRT in the MIRS RTPS 3.0. The work ranges from image acquisition in the TAC, its including quality control, the definition of organs at risk by medical radiation therapists to the data to be transferred to the treatment machine. With this procedure has been possible to establish guidelines for planning 3D-CRT treatments for other locations. (author)

  16. Analysis of Chi-square Automatic Interaction Detection (CHAID) and Classification and Regression Tree (CRT) for Classification of Corn Production

    Science.gov (United States)

    Susanti, Yuliana; Zukhronah, Etik; Pratiwi, Hasih; Respatiwulan; Sri Sulistijowati, H.

    2017-11-01

    To achieve food resilience in Indonesia, food diversification by exploring potentials of local food is required. Corn is one of alternating staple food of Javanese society. For that reason, corn production needs to be improved by considering the influencing factors. CHAID and CRT are methods of data mining which can be used to classify the influencing variables. The present study seeks to dig up information on the potentials of local food availability of corn in regencies and cities in Java Island. CHAID analysis yields four classifications with accuracy of 78.8%, while CRT analysis yields seven classifications with accuracy of 79.6%.

  17. Full-scale mark II CRT program data report, No. 9

    International Nuclear Information System (INIS)

    Takeshita, Isao; Yamamoto, Nobuo; Kukita, Yutaka; Namatame, Ken; Shiba, Masayoshi

    1980-07-01

    Recorded data for TEST 1202 conducted on the Full-Scale Mark II CRT (Containment Responce Test) Facility are presented. The TEST 1202 is a test under the condition of steam discharge with a large break diameter (240 mm) and the second one of the steam discharge pool swell test series. It is also one of the parametric tests with different break diameters, i.e. TEST 1201 (200 mm), TEST 1202 (240 mm) and TEST 1203 (220 mm). The test was successful and a value of 225 kPa/s was obtained as the initial pressurization rate in the drywell. (author)

  18. 38 CFR 21.9765 - Program of education approval.

    Science.gov (United States)

    2010-07-01

    ... education offered by an institution of higher learning if that program of education is approved under 38 U.S... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Program of education... (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approval of Programs of Education § 21...

  19. Elective nodal irradiation (ENI) in definitive chemoradiotherapy (CRT) for squamous cell carcinoma of the thoracic esophagus.

    Science.gov (United States)

    Onozawa, Masakatsu; Nihei, Keiji; Ishikura, Satoshi; Minashi, Keiko; Yano, Tomonori; Muto, Manabu; Ohtsu, Atsushi; Ogino, Takashi

    2009-08-01

    There are some reports indicating that prophylactic three-field lymph node dissection for esophageal cancer can lead to improved survival. But the benefit of ENI in CRT for thoracic esophageal cancer remains controversial. The purpose of the present study is to retrospectively evaluate the efficacy of elective nodal irradiation (ENI) in definitive chemoradiotherapy (CRT) for thoracic esophageal cancer. Patients with squamous cell carcinoma (SCC) of the thoracic esophagus newly diagnosed between February 1999 and April 2001 in our institution was recruited from our database. Definitive chemoradiotherapy consisted of two cycles of cisplatin/5FU repeated every 5 weeks, with concurrent radiation therapy of 60 Gy in 30 fractions. Up to 40 Gy radiation therapy was delivered to the cervical, periesophageal, mediastinal and perigastric lymph nodes as ENI. One hundred two patients were included in this analysis, and their characteristics were as follows: median age, 65 years; male/female, 85/17; T1/T2/T3/T4, 16/11/61/14; N0/N1, 48/54; M0/M1, 84/18. The median follow-up period for the surviving patients was 41 months. Sixty patients achieved complete response (CR). After achieving CR, only one (1.0%; 95% CI, 0-5.3%) patient experienced elective nodal failure without any other site of recurrence. In CRT for esophageal SCC, ENI is effective for preventing regional nodal failure. Further evaluation of whether ENI leads to an improved overall survival is needed.

  20. Heart dose reduction in breast cancer treatment with simultaneous integrated boost. Comparison of treatment planning and dosimetry for a novel hybrid technique and 3D-CRT

    International Nuclear Information System (INIS)

    Joest, Vincent; Kretschmer, Matthias; Sabatino, Marcello; Wuerschmidt, Florian; Dahle, Joerg; Lorenzen, Joern; Ueberle, Friedrich

    2015-01-01

    The present study compares in silico treatment plans of clinically established three-dimensional conformal radiotherapy (3D-CRT) with a hybrid technique consisting of intensity-modulated radiotherapy (IMRT) and volumetric modulated arc radiotherapy (VMAT) during normally fractionated radiation of mammary carcinomas with simultaneous integrated boost on the basis of dose-volume histogram (DVH) parameters. Radiation treatment planning was performed with a hybrid and a 3D-CRT treatment plan for 20 patients. Hybrid plans were implemented with two tangential IMRT fields and a VMAT field in the angular range of the tangents. Verification of the plan was performed with a manufacturer-independent measurement system consisting of a detector array and rotation unit. The mean values of the heart dose for the entire patient collective were 3.6 ± 2.5 Gy for 3D-CRT and 2.9 ± 2.1 Gy for the hybrid technique (p < 0.01). For the left side (n = 10), the mean values for the left anterior descending artery were 21.8 ± 7.4 Gy for 3D-CRT and 17.6 ± 7.4 Gy for the hybrid technique (p < 0.01). The mean values of the ipsilateral lung were 11.9 ± 1.6 Gy for 3D-CRT and 10.5 ± 1.3 Gy for the hybrid technique (p < 0.01). Calculated dose distributions in the hybrid arm were in good accordance with measured dose (on average 95.6 ± 0.5 % for γ < 1 and 3 %/3 mm). The difference of the mean treatment time per fraction was 7 s in favor of 3D-CRT. Compared with the established 3D-CRT technique, the hybrid technique allows for a decrease in dose, particularly of the mean heart and lung dose with comparable target volume acquisition and without disadvantageous low-dose load of contralateral structures. Uncomplicated implementation of the hybrid technique was demonstrated in this context. The hybrid technique combines the advantages of tangential IMRT with the superior sparing of organs at risk by VMAT. (orig.) [de

  1. Down by the Riverside: A CRT Perspective on Education Reform in Two River Cities

    Science.gov (United States)

    Anderson, Celia Rousseau; Dixson, Adrienne D.

    2016-01-01

    In this article, the authors utilize core ideas from Critical Race Theory (CRT) to examine the nature of education reform in two river cities. Similar to other cases of education reform in urban districts, the reforms in the two focal cities reflect at least four characteristics in common: (1) a form of portfolio management; (2) the growth of…

  2. Full-Scale Mark II CRT program data report No. 11 (TEST 1204)

    International Nuclear Information System (INIS)

    Kukita, Yutaka; Takeshita, Isao; Yamamoto, Nobuo; Namatame, Ken; Shiba, Masayoshi

    1981-03-01

    Recorded data for TEST 1204 conducted on the Full-Scale Mark II CRT (Containment Response Test) Facility are presented. The TEST 1204 is the fourth test run of a series of steam discharge pool swell tests. The test conditions are similar to those of the TEST 1203 except for lower initial pool temperature. The test was successful and the maximum level of pool surface was fairly lower than in the TEST 1203 due to the lower pool temperature. (author)

  3. Effectiveness of a management program for outpatient clinic or remote titration of beta-blockers in CRT patients: The RESTORE study.

    Science.gov (United States)

    D'Onofrio, Antonio; Palmisano, Pietro; Rapacciuolo, Antonio; Ammendola, Ernesto; Calò, Leonardo; Ruocco, Antonio; Bianchi, Valter; Maresca, Fabio; Del Giorno, Giuseppe; Martino, Annamaria; Mauro, Ciro; Campari, Monica; Valsecchi, Sergio; Accogli, Michele

    2017-06-01

    Many patients fail to receive β-blockers before cardiac resynchronization therapy defibrillator (CRT-D) implantation, or receive them at a suboptimal dose, and require optimization after implantation. We assessed the effectiveness of a structured program for β-blocker titration in CRT-D patients followed up by means of conventional in-clinic visits or remote monitoring. 130 patients undergoing CRT implantation and treated according to the standard practice of the centers were included as a control group. A second group of 124 CRT-D candidates (Study Group) underwent up-titration visits every 2weeks after implantation (target dose: 10mg/day of bisoprolol or 50mg/day of carvedilol). In the Study Group, remote monitoring was undertaken in 66 patients, who received additional equipment for daily transmission of weight and blood pressure data, and scheduled titration telephone calls. In the Control Group, the maximal dose of β-blockers was being administered to 12 (9%) patients on implantation and 21 (16%) on 6-month follow-up examination (p>0.05). In the Study Group, 25 (20%) patients were receiving the maximal dose of β-blockers on implantation and 72 (58%) on follow-up examination (ptitration (versus 38% of patients followed up conventionally, ptitration increased the number of patients reaching the target dose and improved the response to the therapy. The use of remote monitoring and daily transfer of weight and blood pressure data facilitated β-blocker titration. URL: http://clinicaltrials.gov/ Identifier: NCT02173028. Copyright © 2017. Published by Elsevier B.V.

  4. Pharmacovigilance of biologicals : dynamics in post-approval safety learning

    NARCIS (Netherlands)

    Vermeer, N.S.

    2015-01-01

    Regulatory decisions to allow new drugs on the market by definition have to accept a certain level of uncertainty about the full benefit-risk balance. Pre-approval studies typically provide information on a limited number of patients over a relative short follow-up period, and handle strict

  5. Lead recovery and high silica glass powder synthesis from waste CRT funnel glasses through carbon thermal reduction enhanced glass phase separation process

    Energy Technology Data Exchange (ETDEWEB)

    Xing, Mingfei [Henan Key Laboratory Cultivation Base of Mine Environmental Protection and Ecological Remediation, Henan Polytechnic University, Jiaozuo 454000 Henan China (China); Institute of Resource and Environment, Henan Polytechnic University, Jiaozuo 454000 Henan China (China); Fu, Zegang [Institute of Resource and Environment, Henan Polytechnic University, Jiaozuo 454000 Henan China (China); Wang, Yaping, E-mail: wangyp326@163.com [School of Surveying and Land Information Engineering, Henan Polytechnic University, Jiaozuo 454000, Henan China (China); Wang, Jingyu [Institute of Resource and Environment, Henan Polytechnic University, Jiaozuo 454000 Henan China (China); Zhang, Zhiyuan [Research Center for Eco-Environmental Sciences, Chinese Academy of Sciences, Beijing 100085 (China)

    2017-01-15

    Highlights: • CRT funnel glass was remelted with B{sub 2}O{sub 3} in reducing atmosphere. • A part of PbO was reduced into Pb and detached from the glass phase. • The rest of PbO and other metal oxides were mainly concentrated in the B{sub 2}O{sub 3} phase. • PbO enriched in the interconnected B{sub 2}O{sub 3} phase can be completely leached out by HNO{sub 3}. • High silica glass powder(SiO{sub 2} purity >95%) was obtained after the leaching process. - Abstract: In this study, a novel process for the removal of toxic lead from the CRT funnel glass and synchronous preparation of high silica glass powder was developed by a carbon-thermal reduction enhanced glass phase separation process. CRT funnel glass was remelted with B{sub 2}O{sub 3} in reducing atmosphere. In the thermal process, a part of PbO contained in the funnel glass was reduced into metallic Pb and detached from the glass phase. The rest of PbO and other metal oxides (including Na{sub 2}O, K{sub 2}O, Al{sub 2}O{sub 3,} BaO and CaO) were mainly concentrated in the boric oxide phase. The metallic Pb phase and boric oxide phase were completely leached out by 5 mol/L HNO{sub 3}. The lead removal rate was 99.80% and high silica glass powder (SiO{sub 2} purity >95 wt%) was obtained by setting the temperature, B{sub 2}O{sub 3} added amount and holding time at 1000 °C, 20% and 30 mins, respectively. The prepared high silicate glass powders can be used as catalyst carrier, semipermeable membranes, adsorbents or be remelted into high silicate glass as an ideal substitute for quartz glass. Thus this study proposed an eco-friendly and economical process for recycling Pb-rich electronic glass waste.

  6. Evaluation of display on CRT by various processing digital images

    International Nuclear Information System (INIS)

    Toyama, Yasuhiko; Akagi, Naoki; Ohara, Shuichi; Maeda, Tomoho; Kitazoe, Yasuhiro; Yamamoto, Kouji

    1986-01-01

    In this study, we digitized three sheets of thin line chart X-ray photographs altered the photographic density. By selecting the width of the photographic density at displaying the images on the CRT, We could augment the contrast of images and more easily recognize line images compared with original X-ray photos. This characteristic was clearly observed within the region of low wave length. Though the easy recognition was got by adjusting the contrast, the sharpness of line images was not in accordance with it. As mentioned above, we discussed the relation between the contrast and the sharpness of digitized images obtained with a multi-format camera. (author)

  7. Evaluation of display on CRT by various processing digital images

    Energy Technology Data Exchange (ETDEWEB)

    Toyama, Yasuhiko; Akagi, Naoki; Ohara, Shuichi; Maeda, Tomoho; Kitazoe, Yasuhiro; Yamamoto, Kouji

    1986-12-01

    In this study, we digitized three sheets of thin line chart X-ray photographs altered the photographic density. By selecting the width of the photographic density at displaying the images on the CRT, We could augment the contrast of images and more easily recognize line images compared with original X-ray photos. This characteristic was clearly observed within the region of low wave length. Though the easy recognition was got by adjusting the contrast, the sharpness of line images was not in accordance with it. As mentioned above, we discussed the relation between the contrast and the sharpness of digitized images obtained with a multi-format camera.

  8. Full-scale mark II CRT program data report, (5)

    International Nuclear Information System (INIS)

    Kukita, Yutaka; Namatame, Ken; Yamamoto, Nobuo; Takeshita, Isao; Shiba, Masayoshi

    1980-03-01

    The Full-Scale Mark II CRT (Containment Response Test) Program was initiated in 1977 to provide a data base for evaluation of the LOCA hydrodynamic loads for the Mark II pressure suppression system. The test facility is 1/18 in volume and has a wetwell which is a fullscale replica of one 20 0 -sector of that of a reference Mark II. This report documents test data obtained from TEST 2101, which is a medium size (74 mm) water break test performed on April 27, 1979. TEST 2101 was designed to roughly approximate an intermediate break accident in which so-called chugging phenomenon associated with low-flux steam condensation is anticipated to continue for a longer duration than in a large break accident. (author)

  9. Twiddler's syndrome in a patient with CRT-D device – A case report

    Directory of Open Access Journals (Sweden)

    Dheeraj D. Bhatt

    2015-11-01

    Full Text Available Twiddler's syndrome is a rare cause of pacemaker lead dislodgement. A 61-year-old female patient was implanted with a defibrillator capable of cardiac re-synchronization therapy (CRT-D; 10 months later, she presented with uneasiness and vibratory sensations in the chest. Fluoroscopy revealed rotation of the pulse generator along its longitudinal axis and dislodgement of all three leads. Diagnosis of Twiddler's syndrome was made.

  10. Elective nodal irradiation (ENI) in definitive chemoradiotherapy (CRT) for squamous cell carcinoma of the thoracic esophagus

    International Nuclear Information System (INIS)

    Onozawa, Masakatsu; Nihei, Keiji; Ishikura, Satoshi; Minashi, Keiko; Yano, Tomonori; Muto, Manabu; Ohtsu, Atsushi; Ogino, Takashi

    2009-01-01

    Background and purpose: There are some reports indicating that prophylactic three-field lymph node dissection for esophageal cancer can lead to improved survival. But the benefit of ENI in CRT for thoracic esophageal cancer remains controversial. The purpose of the present study is to retrospectively evaluate the efficacy of elective nodal irradiation (ENI) in definitive chemoradiotherapy (CRT) for thoracic esophageal cancer. Materials and methods: Patients with squamous cell carcinoma (SCC) of the thoracic esophagus newly diagnosed between February 1999 and April 2001 in our institution was recruited from our database. Definitive chemoradiotherapy consisted of two cycles of cisplatin/5FU repeated every 5 weeks, with concurrent radiation therapy of 60 Gy in 30 fractions. Up to 40 Gy radiation therapy was delivered to the cervical, periesophageal, mediastinal and perigastric lymph nodes as ENI. Results: One hundred two patients were included in this analysis, and their characteristics were as follows: median age, 65 years; male/female, 85/17; T1/T2/T3/T4, 16/11/61/14; N0/N1, 48/54; M0/M1, 84/18. The median follow-up period for the surviving patients was 41 months. Sixty patients achieved complete response (CR). After achieving CR, only one (1.0%; 95% CI, 0-5.3%) patient experienced elective nodal failure without any other site of recurrence. Conclusion: In CRT for esophageal SCC, ENI is effective for preventing regional nodal failure. Further evaluation of whether ENI leads to an improved overall survival is needed.

  11. 76 FR 61148 - Proposed Information Collection (Approval of School Attendance) Activity: Comment Request

    Science.gov (United States)

    2011-10-03

    ... marriages, a change in course of instruction and termination of school attendance. Affected Public... (Approval of School Attendance) Activity: Comment Request AGENCY: Veterans Benefits Administration... techniques or the use of other forms of information technology. Titles: a. Request for Approval of School...

  12. Does Unintentional Splenic Radiation Predict Outcomes After Pancreatic Cancer Radiation Therapy?

    Energy Technology Data Exchange (ETDEWEB)

    Chadha, Awalpreet S.; Liu, Guan [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Chen, Hsiang-Chun [Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Das, Prajnan; Minsky, Bruce D.; Mahmood, Usama; Delclos, Marc E. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Suh, Yelin [Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Sawakuchi, Gabriel O. [Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Graduate School of Biomedical Sciences, The University of Texas, Houston, Texas (United States); Beddar, Sam [Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Katz, Matthew H.; Fleming, Jason B. [Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Javle, Milind M.; Varadhachary, Gauri R.; Wolff, Robert A. [Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Crane, Christopher H. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Wang, Xuemei [Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Thames, Howard [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Krishnan, Sunil, E-mail: skrishnan@mdanderson.org [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States)

    2017-02-01

    Purpose: To determine whether severity of lymphopenia is dependent on radiation dose and fractional volume of spleen irradiated unintentionally during definitive chemoradiation (CRT) in patients with locally advanced pancreatic cancer (LAPC). Methods: 177 patients with LAPC received induction chemotherapy (mainly gemcitabine-based regimens) followed by CRT (median 50.4 Gy with concurrent capecitabine) from January 2006 to December 2012. Absolute lymphocyte count (ALC) was recorded at baseline, before CRT, and 2 to 10 weeks after CRT. Splenic dose-volume histogram (DVH) parameters were reported as mean splenic dose (MSD) and percentage of splenic volume receiving at least 5- (V5), 10- (V10), 15- (V15), and 20-Gy (V20) dose. Overall survival (OS) was analyzed with use of the Cox model, and development of post-CRT severe lymphopenia (ALC <0.5 K/UL) was assessed by multivariate logistic regression with use of baseline and treatment factors. Results: The median post-CRT ALC (0.68 K/UL; range, 0.13-2.72) was significantly lower than both baseline ALC (1.42 K/UL; range, 0.34-3.97; P<.0001) and pre-CRT ALC (1.32 K/UL, range 0.36-4.82; P<.0001). Post-CRT ALC <0.5 K/UL was associated with inferior OS on univariate analysis (median, 11.1 vs 15.3 months; P=.01) and multivariate analysis (hazard ratio = 1.66, P=.01). MSD (9.8 vs 6 Gy, P=.03), median V10 (32.6 vs 16%, P=.04), V15 (23.2 vs 9.5%, P=.03), and V20 (15.4 vs 4.6%, P=.02) were significantly higher in patients with severe lymphopenia than in those without. On multivariate analysis, postinduction lymphopenia (P<.001; odds ratio [OR] = 5.25) and MSD (P=.002; OR= 3.42) were independent predictors for the development of severe post-CRT lymphopenia. Conclusion: Severe post-CRT lymphopenia is an independent predictor of poor OS in LAPC patients receiving CRT. Higher splenic doses increase the risk for the development of severe post-CRT lymphopenia. When clinically indicated, assessment of splenic DVHs before the

  13. Does Unintentional Splenic Radiation Predict Outcomes After Pancreatic Cancer Radiation Therapy?

    International Nuclear Information System (INIS)

    Chadha, Awalpreet S.; Liu, Guan; Chen, Hsiang-Chun; Das, Prajnan; Minsky, Bruce D.; Mahmood, Usama; Delclos, Marc E.; Suh, Yelin; Sawakuchi, Gabriel O.; Beddar, Sam; Katz, Matthew H.; Fleming, Jason B.; Javle, Milind M.; Varadhachary, Gauri R.; Wolff, Robert A.; Crane, Christopher H.; Wang, Xuemei; Thames, Howard; Krishnan, Sunil

    2017-01-01

    Purpose: To determine whether severity of lymphopenia is dependent on radiation dose and fractional volume of spleen irradiated unintentionally during definitive chemoradiation (CRT) in patients with locally advanced pancreatic cancer (LAPC). Methods: 177 patients with LAPC received induction chemotherapy (mainly gemcitabine-based regimens) followed by CRT (median 50.4 Gy with concurrent capecitabine) from January 2006 to December 2012. Absolute lymphocyte count (ALC) was recorded at baseline, before CRT, and 2 to 10 weeks after CRT. Splenic dose-volume histogram (DVH) parameters were reported as mean splenic dose (MSD) and percentage of splenic volume receiving at least 5- (V5), 10- (V10), 15- (V15), and 20-Gy (V20) dose. Overall survival (OS) was analyzed with use of the Cox model, and development of post-CRT severe lymphopenia (ALC <0.5 K/UL) was assessed by multivariate logistic regression with use of baseline and treatment factors. Results: The median post-CRT ALC (0.68 K/UL; range, 0.13-2.72) was significantly lower than both baseline ALC (1.42 K/UL; range, 0.34-3.97; P<.0001) and pre-CRT ALC (1.32 K/UL, range 0.36-4.82; P<.0001). Post-CRT ALC <0.5 K/UL was associated with inferior OS on univariate analysis (median, 11.1 vs 15.3 months; P=.01) and multivariate analysis (hazard ratio = 1.66, P=.01). MSD (9.8 vs 6 Gy, P=.03), median V10 (32.6 vs 16%, P=.04), V15 (23.2 vs 9.5%, P=.03), and V20 (15.4 vs 4.6%, P=.02) were significantly higher in patients with severe lymphopenia than in those without. On multivariate analysis, postinduction lymphopenia (P<.001; odds ratio [OR] = 5.25) and MSD (P=.002; OR= 3.42) were independent predictors for the development of severe post-CRT lymphopenia. Conclusion: Severe post-CRT lymphopenia is an independent predictor of poor OS in LAPC patients receiving CRT. Higher splenic doses increase the risk for the development of severe post-CRT lymphopenia. When clinically indicated, assessment of splenic DVHs before the

  14. Single-arc volumetric-modulated arc therapy (sVMAT) as adjuvant treatment for gastric cancer: Dosimetric comparisons with three-dimensional conformal radiotherapy (3D-CRT) and intensity-modulated radiotherapy (IMRT)

    International Nuclear Information System (INIS)

    Wang, Xin; Li, Guangjun; Zhang, Yingjie; Bai, Sen; Xu, Feng; Wei, Yuquan; Gong, Youling

    2013-01-01

    To compare the dosimetric differences between the single-arc volumetric-modulated arc therapy (sVMAT), 3-dimensional conformal radiotherapy (3D-CRT), and intensity-modulated radiotherapy (IMRT) techniques in treatment planning for gastric cancer as adjuvant radiotherapy. Twelve patients were retrospectively analyzed. In each patient's case, the parameters were compared based on the dose-volume histogram (DVH) of the sVMAT, 3D-CRT, and IMRT plans, respectively. Three techniques showed similar target dose coverage. The maximum and mean doses of the target were significantly higher in the sVMAT plans than that in 3D-CRT plans and in the 3D-CRT/IMRT plans, respectively, but these differences were clinically acceptable. The IMRT and sVMAT plans successfully achieved better target dose conformity, reduced the V 20/30 , and mean dose of the left kidney, as well as the V 20/30 of the liver, compared with the 3D-CRT plans. And the sVMAT technique reduced the V 20 of the liver much significantly. Although the maximum dose of the spinal cord were much higher in the IMRT and sVMAT plans, respectively (mean 36.4 vs 39.5 and 40.6 Gy), these data were still under the constraints. Not much difference was found in the analysis of the parameters of the right kidney, intestine, and heart. The IMRT and sVMAT plans achieved similar dose distribution to the target, but superior to the 3D-CRT plans, in adjuvant radiotherapy for gastric cancer. The sVMAT technique improved the dose sparings of the left kidney and liver, compared with the 3D-CRT technique, but showed few dosimetric advantages over the IMRT technique. Studies are warranted to evaluate the clinical benefits of the VMAT treatment for patients with gastric cancer after surgery in the future

  15. Effect of leukocyte alteration on treatment outcomes following preoperative chemoradiotherapy in patients with rectal cancer

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Tae Gyu; Park, Won; Choi, Doo Ho [Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul (Korea, Republic of); and others

    2017-09-15

    Hematotoxicity following anti-cancer treatment is known to be related to treatment efficacy in several malignancies. The purpose of this study was to examine the hematologic parameters related to the tumor response and survival in patients treated with curative surgery following preoperative chemoradiotherapy (CRT) for rectal cancer. Four hundred eighteen patients with rectal cancer who underwent preoperative CRT and curative surgery were analyzed, retrospectively. The main clinical factors and blood cell counts before and after CRT were investigated with respect to their relationships with tumor downstaging and patient survival. The post-CRT leukocyte count was significantly different between the tumor downstaging group and the nondownstaging group (median, 4740/uL vs. 5130/uL; p = 0.013). Multivariate analysis showed that histological grade, circumferential extent, and post-CRT leukocyte count were related to tumor downstaging. In addition, histological grade, post-CRT leukocyte count, and tumor downstaging were related to disease-free survival. The 5-year disease-free survival and overall survival in patients with post-CRT leukocyte count ≤3730/uL, which is the cut-off value derived from the receiver operation characteristic (ROC) curve analysis, were significantly higher than those with higher counts (88.0% vs. 71.6%, p = 0.001; 94.4% vs. 84.1%, p = 0.024). Post-CRT leukocyte count of ≤3730/uL could be regarded as a good prognostic factor for tumor response and survival in rectal cancer patients treated with preoperative CRT.

  16. Long-term effects of cranial irradiation on endocrine function in children with brain tumors. A prospective study

    International Nuclear Information System (INIS)

    Duffner, P.K.; Cohen, M.E.; Voorhess, M.L.; MacGillivray, M.H.; Brecher, M.L.; Panahon, A.; Gilani, B.B.

    1985-01-01

    This study prospectively evaluated the endocrine function of 11 children treated with cranial irradiation (CRT) for brain tumors. All tumors were remote from the hypothalamic-pituitary axis. Children were studied before treatment and at 3, 6, and 12 months after the completion of CRT. T4, thyroid-stimulating hormone, prolactin, plasma cortisol, and urinary follicle-stimulating hormone and luteinizing hormone values were normal before and after treatment in all patients. Growth hormone (GH) deficiency was identified in 0 of 7 patients before treatment, in 2 of 7 patients 3 months post-CRT, in 9 of 11 patients 6 months post-CRT, and in 7 of 8 patients 12 months post-CRT. Growth deceleration was identified in five of seven prepubertal patients. GH deficiency is an extremely common sequelae of CRT, beginning as early as 3 months after the completion of CRT. The deficit is progressive over time

  17. Feasibility and efficacy of helical intensity-modulated radiotherapy for stage III non-small cell lung cancer in comparison with conventionally fractionated 3D-CRT.

    Science.gov (United States)

    He, Jian; Huang, Yan; Chen, Yixing; Shi, Shiming; Ye, Luxi; Hu, Yong; Zhang, Jianying; Zeng, Zhaochong

    2016-05-01

    The standard treatment for stage III non-small-cell lung cancer (NSCLC) is still 60 Gy in conventional fractions combined with concurrent chemotherapy; however, the resulting local controls are disappointing. The aim of this study was to compare and assess the feasibility and efficacy of hypofractionated chemoradiotherapy using helical tomotherapy (HT) with conventional fractionation as opposed to using three-dimensional conformal radiotherapy (3D-CRT) for stage III NSCLC. Sixty-nine patients with stage III (AJCC 7th edition) NSCLC who underwent definitive radiation treatment at our institution between July 2011 and November 2013 were reviewed and analyzed retrospectively. A dose of 60 Gy in 20 fractions was delivered in the HT group (n=34), whereas 60 Gy in 30 fractions in the 3D-CRT group (n=35). Primary endpoints were toxicity, overall response rate, overall survival (OS) and progression-free survival (PFS). The median follow-up period was 26.4 months. V20 (P=0.005), V30 (P=0.001), V40 (P=0.004), mean lung dose (P=0.000) and max dose of spinal cord (P=0.005) were significantly lower in the HT group than in the 3D-CRT group. There was no significant difference in the incidences of acute radiation pneumonitis (RP) ≥ grade 2 between the two groups, whereas the incidences of acute radiation esophagitis ≥ grade 2 were significantly lower in the HT group than in the 3D-CRT group (P=0.027). Two-year overall response rate was significantly higher in the HT group than in the 3D-CRT group (P=0.015). One- and 2-year OS rates were significantly higher in the HT group (95.0% and 68.7%, respectively) than in the 3D-CRT group (85.5% and 47.6%, respectively; P=0.0236). One- and 2-year PFS rates were significantly higher in the HT group (57.8% and 26.3%, respectively) than in the 3D-CRT group (32.7% and 11.4%, respectively; P=0.0351). Univariate analysis indicated that performance status (PS), T stage and radiotherapy technique were significant prognostic factors for both OS

  18. V–V delay interval optimization in CRT using echocardiography compared to QRS width in surface ECG

    Directory of Open Access Journals (Sweden)

    Amr Nawar

    2012-09-01

    Conclusion: Significant correlation appeared to exist during optimization of CRT between VV programming based on the shortest QRS interval at 12-lead ECG pacing and that based on highest LVOT VTI by echocardiography. A combined ECG and echocardiographic approach could be a more convenient solution in performing V–V optimization.

  19. 78 FR 69664 - Proposed Information Collection Request; Comment Request; Approval of State Coastal Nonpoint...

    Science.gov (United States)

    2013-11-20

    ... Collection Request; Comment Request; Approval of State Coastal Nonpoint Pollution Control Programs AGENCY... to submit an information collection request (ICR), ``Approval of State Coastal Nonpoint Pollution... Watershed Protection Division, Office of Wetlands Oceans and Watersheds, Mail Code 4503-T, Environmental...

  20. The crtS gene of Xanthophyllomyces dendrorhous encodes a novel cytochrome-P450 hydroxylase involved in the conversion of beta-carotene into astaxanthin and other xanthophylls.

    Science.gov (United States)

    Alvarez, Vanessa; Rodríguez-Sáiz, Marta; de la Fuente, Juan Luis; Gudiña, Eduardo J; Godio, Ramiro P; Martín, Juan F; Barredo, José Luis

    2006-04-01

    The conversion of beta-carotene into xanthophylls is a subject of great scientific and industrial interest. We cloned the crtS gene involved in astaxanthin biosynthesis from two astaxanthin producing strains of Xanthophyllomyces dendrorhous: VKPM Y2410, an astaxanthin overproducing strain, and the wild type ATCC 24203. In both cases, the ORF has a length of 3166 bp, including 17 introns, and codes for a protein of 62.6 kDa with similarity to cytochrome-P450 hydroxylases. crtS gene sequences from strains VKPM Y2410, ATCC 24203, ATCC 96594, and ATCC 96815 show several nucleotide changes, but none of them causes any amino acid substitution, except a G2268 insertion in the 13th exon of ATCC 96815 which causes a change in the reading frame. A G1470 --> A change in the 5' splicing region of intron 8 was also found in ATCC 96815. Both point mutations explain astaxanthin idiotrophy and beta-carotene accumulation in ATCC 96815. Mutants accumulating precursors of the astaxanthin biosynthetic pathway were selected from the parental strain VKPM Y2410 (red) showing different colors depending on the compound accumulated. Two of them were blocked in the biosynthesis of astaxanthin, M6 (orange; 1% astaxanthin, 71 times more beta-carotene) and M7 (orange; 1% astaxanthin, 58 times more beta-carotene, 135% canthaxanthin), whereas the rest produced lower levels of astaxanthin (5-66%) than the parental strain. When the crtS gene was expressed in M7, canthaxanthin accumulation disappeared and astaxanthin production was partially restored. Moreover, astaxanthin biosynthesis was restored when X. dendrorhous ATCC 96815 was transformed with the crtS gene. The crtS gene was heterologously expressed in Mucor circinelloides conferring to this fungus an improved capacity to synthesize beta-cryptoxanthin and zeaxanthin, two hydroxylated compounds from beta-carotene. These results show that the crtS gene is involved in the conversion of beta-carotene into xanthophylls, being potentially useful to

  1. Full-scale Mark II CRT program: dynamic response evaluation test of pressure transducers

    International Nuclear Information System (INIS)

    Kukita, Yutaka; Namatame, Ken; Takeshita, Isao; Shiba, Masayoshi

    1982-12-01

    A dynamic response evaluation test of pressure transducers was conducted in support of the JAERI Full-Scale Mark II CRT (Containment Response Test) Program. The test results indicated that certain of the cavity-type transducers used in the early blowdown test had undesirable response characteristics. The transducer mounting scheme was modified to avoid trapping of air bubbles in the pressure transmission tubing attached to the transducers. The dynamic response of the modified transducers was acceptable within the frequency range of 200 Hz. (author)

  2. 75 FR 39619 - Proposed Information Collection (Quarterly Report of State Approving Agency) Activities Activity...

    Science.gov (United States)

    2010-07-09

    ... information needed to accurately reimburse State Approving Agencies (SAAs) for expenses incurred in the... reimburses SAAs for expenses incurred in the approval and supervision of education and training programs. SAAs are required to report their activities to VA quarterly and provide notices regarding which...

  3. 77 FR 33788 - Proposed Post Office Structure Plan

    Science.gov (United States)

    2012-06-07

    ... Plan AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission is noticing a recently-filed Postal Service request for an advisory opinion regarding its Post Office Structure Plan... Commission for an advisory opinion under 39 U.S.C. 3661 regarding its Post Office Structure Plan (POStPlan...

  4. Full-Scale Mark II CRT program data report no. 10 (TEST 1203)

    International Nuclear Information System (INIS)

    Kukita, Yutaka; Takeshita, Isao; Yamamoto, Nobuo; Namatame, Ken; Shiba, Masayoshi

    1981-03-01

    Recorded data for TEST 1203 conducted on the Full-Scale Mark II CRT (Containment Response Test) Facility are presented. The test 1203 is the third test run of a series of steam discharge pool swell test. It is one of the tests where break diameter was varied parametrically, i.e., TEST 1201 (200 mm), TEST 1202 (240 mm) and TEST 1203 (220 mm). The test was successfully conducted. A drywell initial pressurization rate of 188 kPa/s was obtained, which is approximately equal to what is postulated for a hypothetical DBA (Design Basis Accident) LOCA in the BWR Mark II containment. (author)

  5. Full-Scale Mark II CRT program data report no. 12 (TEST 1205)

    International Nuclear Information System (INIS)

    Takeshita, Isao; Kukita, Yutaka; Yamamoto, Nubuo; Namatame, Ken; Shiba, Masayoshi

    1981-03-01

    Recorded data for TEST 1205 conducted on the Full-Scale Mark II CRT (Containment Response Test) Facility are presented. The TEST 1205 is the fifth test run of a series of steam discharge pool swell tests. The test conditions are similar to those of the TEST 1203 except that the vacuum breaker was locked close. The test was successful and the comparison of the TEST 1205 and the TEST 1203 results shows that the vacuum breaker may have some effects to reduce the wetwell airspace pressurization, and thus to reduce the upward force to diaphram floor during a pool swell. (author)

  6. Locally advanced rectal cancer: diffusion-weighted MR tumour volumetry and the apparent diffusion coefficient for evaluating complete remission after preoperative chemoradiation therapy

    Energy Technology Data Exchange (ETDEWEB)

    Ha, Hong Il [University of Ulsan College of Medicine, Asan Medical Center, Department of Radiology and Research Institute of Radiology, Seoul (Korea, Republic of); Hallym University Medical Center, Hallym University Sacred Heart Hospital, Department of Radiology, Anyang-si, Gyeonggi-do (Korea, Republic of); Kim, Ah Young; Park, Seong Ho; Ha, Hyun Kwon [University of Ulsan College of Medicine, Asan Medical Center, Department of Radiology and Research Institute of Radiology, Seoul (Korea, Republic of); Yu, Chang Sik [University of Ulsan College of Medicine, Asan Medical Center, Department of Colon and Rectal Surgery, Seoul (Korea, Republic of)

    2013-12-15

    To evaluate DW MR tumour volumetry and post-CRT ADC in rectal cancer as predicting factors of CR using high b values to eliminate perfusion effects. One hundred rectal cancer patients who underwent 1.5-T rectal MR and DW imaging using three b factors (0, 150, and 1,000 s/mm{sup 2}) were enrolled. The tumour volumes of T2-weighted MR and DW images and pre- and post-CRT ADC{sub 150-1000} were measured. The diagnostic accuracy of post-CRT ADC, T2-weighted MR, and DW tumour volumetry was compared using ROC analysis. DW MR tumour volumetry was superior to T2-weighted MR volumetry comparing the CR and non-CR groups (P < 0.001). Post-CRT ADC showed a significant difference between the CR and non-CR groups (P = 0.001). The accuracy of DW tumour volumetry (A{sub z} = 0.910) was superior to that of T2-weighed MR tumour volumetry (A{sub z} = 0.792) and post-CRT ADC (A{sub z} = 0.705) in determining CR (P = 0.015). Using a cutoff value for the tumour volume reduction rate of more than 86.8 % on DW MR images, the sensitivity and specificity for predicting CR were 91.4 % and 80 %, respectively. DW MR tumour volumetry after CRT showed significant superiority in predicting CR compared with T2-weighted MR images and post-CRT ADC. (orig.)

  7. Acute toxicity of chemoradiation therapy (CRT) for rectal cancer: Impact of irradiated volume, type of surgery, sex and sequence of treatment modalities

    International Nuclear Information System (INIS)

    Fietkau, R.; Roedel, C.; Grabenbauer, G.G.; Kessler, H.; Martus, P.; Sauer, R.

    1996-01-01

    Purpose: In an attempt to reduce acute toxicity of CRT for rectal cancer we retrospectively evaluated potential factors that influence the severity of toxic side-effects. Materials and Methods: Between 1987 and 1995, 120 patients (pts, 73 with primary tumor, 47 with recurrent disease) received CRT for rectal cancer. RT was given by 3-4 field box technique with 6-10 MV-photons. Daily fraction size was 180 cGy, total dose 5040 cGy including 540 cGy local boost. Dose was specified to the ICRU reference point. During the first and fifth week of RT 5-FU (1000 mg/m 2 /24 h) was administered by continuous infusion for 120 hours. 56 pts received preoperative CRT, 64 pts were treated postoperatively. Toxicity was recorded following (modified) WHO-criteria. Results: Acute grade 4 toxicity was limited to 3 pts (leukopenia, sepsis, arrhythmia). Acute grade 3 toxicity occurred mainly as diarrhea (33%), perineal skin reaction (37%), and leukopenia (9%). Extension of the treatment volume including paraaortic lymph nodes (L3) led to a significant increase of grade 3 diarrhea (68% vs. 25%, p = 0,0003) and grade 3 leukopenia (18% vs. 8%, p = 0,03). After abdominoperineal resection less pts suffered from grade 3 diarrhea (8% vs. 47% after sphincter-preserving procedures, p = 0,0006), whereas severe perineal erythema occurred more frequently (56% vs. 29%, p = 0,02). Women had significantly more toxic side effects (grade 3 diarrhea: 39% vs. 16% in men, p = 0.04; grade 2 to 3 nausea/emesis: 21% vs. 8% in men, p = 0.018; grade 2 to 3 leukopenia: 53% vs. 31% in men, p = 0, 02). After preoperative CRT a significant reduction of grade 3 diarrhea (11% vs. 29%, p = 0.03) and grade 3 erythema (16% vs. 41%, p = 0.04) was noted. Conclusion: In order to reduce acute treatment related toxicity preoperative CRT deserves further evaluation. Careful attention should be paid to the extension of treatment volume to the paraaortic region. Individual adjustment of 5-FU dosage by monitoring its systemic

  8. Full-Scale Mark II CRT Program data report, 1

    International Nuclear Information System (INIS)

    Namatame, Ken; Kukita, Yutaka; Yamamoto, Nobuo; Shiba, Masayoshi

    1979-12-01

    The Full-Scale Mark II CRT (Containment Response Test) Program was initiated in April 1976 to provide a full-scale data basis for the evaluation of the pressure suppression pool hydrodynamic loads associated with a hypothetical LOCA in a BWR Mark II Containment. The test facility, completed in March 1979, is 1/18 in volume of a typical 1100 MWe Mark II, and has a wetwell which is a full-scale replica of one 20 0 -sector of that of the reference Mark II. The present report documents experimental data from TEST 0002, a medium size (100 mm) water blowdown test, performed by Hitachi Ltd. for JAERI as the second of the four shakedown tests. Test data is provided for the vessel depressurization, the pressure and temperature responses in the test containment, and especially for the chugging phenomena associated with low flux steam condensation in the pool. (author)

  9. Comparison of 3D CRT and IMRT Tratment Plans

    Science.gov (United States)

    Bakiu, Erjona; Telhaj, Ervis; Kozma, Elvisa; Ruçi, Ferdinand; Malkaj, Partizan

    2013-01-01

    Plans of patients with prostate tumor have been studied. These patients have been scanned in the CT simulator and the images have been sent to the Focal, the system where the doctor delineates the tumor and the organs at risk. After that in the treatment planning system XiO there are created for the same patients three dimensional conformal and intensity modulated radiotherapy treatment plans. The planes are compared according to the dose volume histograms. It is observed that the plans with IMRT technique conform better the isodoses to the planning target volume and protect more the organs at risk, but the time needed to create such plans and to control it is higher than 3D CRT. So it necessary to decide in which patients to do one or the other technique depending on the full dose given to PTV and time consuming in genereral. PMID:24167395

  10. Leveraging CRT Awareness in Creating Web-Based Projects through Use of Online Collaborative Learning for Pre-Service Teachers

    Science.gov (United States)

    Chuang, Hsueh-Hua

    2016-01-01

    This paper explores the roles played by cloud computing technologies and social media in facilitating a learning community for online group collaborative learning, and particularly explores opportunities and challenges in leveraging culturally responsive teaching (CRT) awareness in educational technology. It describes implementation of a…

  11. 75 FR 54654 - Agency Information Collection Activities; Proposals, Submissions, and Approvals

    Science.gov (United States)

    2010-09-08

    ... appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of.... Type of Review: Extension without change of a previously approved collection. Title of Collection.... Affected Public: Businesses or other for-profits, Federal Government. Total Estimated Number of Responses...

  12. Post-approval monitoring and oversight of U.S.-initiated human subjects research in resource-constrained countries.

    Science.gov (United States)

    Brown, Brandon; Kinsler, Janni; Folayan, Morenike O; Allen, Karen; Cáceres, Carlos F

    2014-06-01

    The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study's investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of research regulatory structures, arranging a site visit from a U.S. research ethics committee (REC) becomes difficult, thus creating a potential barrier to regulatory oversight by the parent REC. However, this barrier may be overcome through the use of digital technologies, since much of the world has at least remote access to the Internet. Empirical research is needed to pilot test the use of these technologies for research oversight to ensure the protection of human subjects taking part in research worldwide.

  13. Persistently better treatment planning results of intensity-modulated (IMRT) over conformal radiotherapy (3D-CRT) in prostate cancer patients with significant variation of clinical target volume and/or organs-at-risk

    International Nuclear Information System (INIS)

    Fenoglietto, Pascal; Laliberte, Benoit; Allaw, Ali; Ailleres, Norbert; Idri, Katia; Hay, Meng Huor; Moscardo, Carmen Llacer; Gourgou, Sophie; Dubois, Jean-Bernard; Azria, David

    2008-01-01

    Purpose: To compare the dose coverage of planning and clinical target volume (PTV, CTV), and organs-at-risk (OAR) between intensity-modulated (3D-IMRT) and conventional conformal radiotherapy (3D-CRT) before and after internal organ variation in prostate cancer. Methods and materials: We selected 10 patients with clinically significant interfraction volume changes. Patients were treated with 3D-IMRT to 80 Gy (minimum PTV dose of 76 Gy, excluding rectum). Fictitious, equivalent 3D-CRT plans (80 Gy at isocenter, with 95% isodose (76 Gy) coverage of PTV, with rectal blocking above 76 Gy) were generated using the same planning CT data set ('CT planning'). The plans were then also applied to a verification CT scan ('CT verify') obtained at a different moment. PTV, CTV, and OAR dose coverage were compared using non-parametric tests statistics for V95, V90 (% of the volume receiving ≥95 or 90% of the dose) and D50 (dose to 50% of the volume). Results: Mean V95 of the PTV for 'CT planning' was 94.3% (range, 88-99) vs 89.1% (range, 84-94.5) for 3D-IMRT and 3D-CRT (p = 0.005), respectively. Mean V95 of the CTV for 'CT verify' was 97% for both 3D-IMRT and 3D-CRT. Mean D50 of the rectum for 'CT planning' was 26.8 Gy (range, 22-35) vs 43.5 Gy (range, 33.5-50.5) for 3D-IMRT and 3D-CRT (p = 0.0002), respectively. For 'CT verify', this D50 was 31.1 Gy (range, 16.5-44) vs 44.2 Gy (range, 34-55) for 3D-IMRT and 3D-CRT (p = 0.006), respectively. V95 of the rectum was 0% for both plans for 'CT planning', and 2.3% (3D-IMRT) vs 2.1% (3D-CRT) for 'CT verify' (p = non-sig.). Conclusion: Dose coverage of the PTV and OAR was better with 3D-IMRT for each patient and remained so after internal volume changes

  14. An application of the process computer and CRT display system in BWR nuclear power station

    International Nuclear Information System (INIS)

    Goto, Seiichiro; Aoki, Retsu; Kawahara, Haruo; Sato, Takahisa

    1975-01-01

    A color CRT display system was combined with a process computer in some BWR nuclear power plants in Japan. Although the present control system uses the CRT display system only as an output device of the process computer, it has various advantages over conventional control panel as an efficient plant-operator interface. Various graphic displays are classified into four categories. The first is operational guide which includes the display of control rod worth minimizer and that of rod block monitor. The second is the display of the results of core performance calculation which include axial and radial distributions of power output, exit quality, channel flow rate, CHFR (critical heat flux ratio), FLPD (fraction of linear power density), etc. The third is the display of process variables and corresponding computational values. The readings of LPRM, control rod position and the process data concerning turbines and feed water system are included in this category. The fourth category includes the differential axial power distribution between base power distribution (obtained from TIP) and the reading of each LPRM detector, and the display of various input parameters being used by the process computer. Many photographs are presented to show examples of those applications. (Aoki, K.)

  15. Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

    Science.gov (United States)

    Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

    2017-06-01

    An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post

  16. Locally advanced rectal cancer: diffusion-weighted MR tumour volumetry and the apparent diffusion coefficient for evaluating complete remission after preoperative chemoradiation therapy

    International Nuclear Information System (INIS)

    Ha, Hong Il; Kim, Ah Young; Park, Seong Ho; Ha, Hyun Kwon; Yu, Chang Sik

    2013-01-01

    To evaluate DW MR tumour volumetry and post-CRT ADC in rectal cancer as predicting factors of CR using high b values to eliminate perfusion effects. One hundred rectal cancer patients who underwent 1.5-T rectal MR and DW imaging using three b factors (0, 150, and 1,000 s/mm 2 ) were enrolled. The tumour volumes of T2-weighted MR and DW images and pre- and post-CRT ADC 150-1000 were measured. The diagnostic accuracy of post-CRT ADC, T2-weighted MR, and DW tumour volumetry was compared using ROC analysis. DW MR tumour volumetry was superior to T2-weighted MR volumetry comparing the CR and non-CR groups (P z = 0.910) was superior to that of T2-weighed MR tumour volumetry (A z = 0.792) and post-CRT ADC (A z = 0.705) in determining CR (P = 0.015). Using a cutoff value for the tumour volume reduction rate of more than 86.8 % on DW MR images, the sensitivity and specificity for predicting CR were 91.4 % and 80 %, respectively. DW MR tumour volumetry after CRT showed significant superiority in predicting CR compared with T2-weighted MR images and post-CRT ADC. (orig.)

  17. Locally advanced rectal cancer: diffusion-weighted MR tumour volumetry and the apparent diffusion coefficient for evaluating complete remission after preoperative chemoradiation therapy.

    Science.gov (United States)

    Ha, Hong Il; Kim, Ah Young; Yu, Chang Sik; Park, Seong Ho; Ha, Hyun Kwon

    2013-12-01

    To evaluate DW MR tumour volumetry and post-CRT ADC in rectal cancer as predicting factors of CR using high b values to eliminate perfusion effects. One hundred rectal cancer patients who underwent 1.5-T rectal MR and DW imaging using three b factors (0, 150, and 1,000 s/mm(2)) were enrolled. The tumour volumes of T2-weighted MR and DW images and pre- and post-CRT ADC150-1000 were measured. The diagnostic accuracy of post-CRT ADC, T2-weighted MR, and DW tumour volumetry was compared using ROC analysis. DW MR tumour volumetry was superior to T2-weighted MR volumetry comparing the CR and non-CR groups (P volumetry (Az = 0.910) was superior to that of T2-weighed MR tumour volumetry (Az = 0.792) and post-CRT ADC (Az = 0.705) in determining CR (P = 0.015). Using a cutoff value for the tumour volume reduction rate of more than 86.8 % on DW MR images, the sensitivity and specificity for predicting CR were 91.4 % and 80 %, respectively. DW MR tumour volumetry after CRT showed significant superiority in predicting CR compared with T2-weighted MR images and post-CRT ADC.

  18. LCDs are better: psychophysical and photometric estimates of the temporal characteristics of CRT and LCD monitors.

    Science.gov (United States)

    Lagroix, Hayley E P; Yanko, Matthew R; Spalek, Thomas M

    2012-07-01

    Many cognitive and perceptual phenomena, such as iconic memory and temporal integration, require brief displays. A critical requirement is that the image not remain visible after its offset. It is commonly believed that liquid crystal displays (LCD) are unsuitable because of their poor temporal response characteristics relative to cathode-ray-tube (CRT) screens. Remarkably, no psychophysical estimates of visible persistence are available to verify this belief. A series of experiments in which white stimuli on a black background produced discernible persistence on CRT but not on LCD screens, during both dark- and light-adapted viewing, falsified this belief. Similar estimates using black stimuli on a white background produced no visible persistence on either screen. That said, photometric measurements are available that seem to confirm the poor temporal characteristics of LCD screens, but they were obtained before recent advances in LCD technology. Using current LCD screens, we obtained photometric estimates of rise time far shorter (1-6 ms) than earlier estimates (20-150 ms), and approaching those of CRTs (<1 ms). We conclude that LCDs are preferable to CRTs when visible persistence is a concern, except when black-on-white displays are used.

  19. 40 CFR 57.602 - Approval of proposal.

    Science.gov (United States)

    2010-07-01

    ... § 57.603. The application shall also specify: (1) The design and substantive elements of the research...) The smelter owner's proposal. The smelter owner's NSO application shall include a proposed NSO... agency is that the planned work must yield the most cost effective technology possible. (c) Optional...

  20. 75 FR 36301 - Review and Approval of Projects

    Science.gov (United States)

    2010-06-25

    ... SUSQUEHANNA RIVER BASIN COMMISSION 18 CFR Parts 806 and 808 Review and Approval of Projects AGENCY... document contains proposed rules that would amend the project review regulations of the Susquehanna River... the scope of withdrawals requiring review and approval; improve notice procedures for all project...

  1. A protocol for patients with cardiovascular implantable devices undergoing magnetic resonance imaging (MRI): should defibrillation threshold testing be performed post-(MRI).

    Science.gov (United States)

    Burke, Peter Thomas; Ghanbari, Hamid; Alexander, Patrick B; Shaw, Michael K; Daccarett, Marcos; Machado, Christian

    2010-06-01

    Magnetic resonance imaging (MRI) in patients with Cardiovascular Implantable Electronic Devices (CIED) has not been approved by the Food and Drug Administration. Recent data suggests MRI as a relative rather than absolute contraindication in CIED patients. Recently, the American Heart Association has recommended defibrillation threshold testing (DFTT) in implantable cardioverter defibrillator (ICD) patients undergoing MRI. We evaluated the feasibility and safety of a protocol for MRI in CIED patients, incorporating the new recommendations on DFTT. Consecutive patients with CIED undergoing MRI were included. The protocol consisted of continuous monitoring during imaging, device interrogation pre- and post-MRI, reprogramming of the pacemaker to an asynchronous mode in pacemaker-dependent (PMD) patients and a non-tracking/sensing mode for non-PMD patients. All tachyarrhythmia therapies were disabled. Devices were interrogated for lead impedance, battery life, pacing, and sensing thresholds. All patients with ICD underwent DFTT/defibrillator safety margin testing (DSMT) post-MRI. A total of 92 MRI's at 1.5 Tesla were performed in 38 patients. A total of 13 PMD patients, ten ICD patients, four cardiac resynchronization therapy with defibrillator (CRT-D) patients, and 11 non-PMD patients were scanned from four major manufacturers. No device circuitry damage, programming alterations, inappropriate shocks, failure to pace, or changes in sensing, pacing, or defibrillator thresholds were found on single or multiple MRI sessions. Our protocol for MRI in CIED patients appears safe, feasible, and reproducible. This is irrespective of the type of CIED, pacemaker dependancy or multiple 24-h scanning sessions. Our protocol addresses early detection of potential complications and establishes a response system for potential device-related complications. Our observation suggests that routine DFTT/DSMT post-MRI may not be necessary.

  2. Optimized Synthesis of Foam Glass from Recycled CRT Panel Glass

    DEFF Research Database (Denmark)

    Petersen, Rasmus Rosenlund; König, Jakob; Yue, Yuanzheng

    Most of the panel glass from cathode ray tubes (CRTs) is landfilled today. Instead of landfilling, the panel glass can be turned into new environment-friendly foam glass. Low density foam glass is an effective heat insulating material and can be produced just by using recycle glass and foaming...... additives. In this work we recycle the CRT panel glass to synthesize the foam glass as a crucial component of building and insulating materials. The synthesis conditions such as foaming temperature, duration, glass particle size, type and concentrations of foaming agents, and so on are optimized...... by performing systematic experiments. In particular, the concentration of foaming agents is an important parameter that influences the size of bubbles and the distribution of bubbles throughout the sample. The foam glasses are characterised regarding density and open/closed porosity. Differential scanning...

  3. Comparison and Limitations of DVH-Based NTCP Models Derived From 3D-CRT and IMRT Data for Prediction of Gastrointestinal Toxicities in Prostate Cancer Patients by Using Propensity Score Matched Pair Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Troeller, Almut [Department of Radiation Oncology, William Beaumont Health System, Royal Oak, Michigan (United States); Department of Radiotherapy and Radiation Oncology, Ludwig-Maximilians-Universität, Munich (Germany); Yan, Di, E-mail: dyan@beaumont.edu [Department of Radiation Oncology, William Beaumont Health System, Royal Oak, Michigan (United States); Marina, Ovidiu; Schulze, Derek [Department of Radiation Oncology, William Beaumont Health System, Royal Oak, Michigan (United States); Alber, Markus [Department of Oncology, Aarhus University Hospital, Aarhus (Denmark); Parodi, Katia [Department of Medical Physics, Ludwig-Maximilians-Universität, Munich (Germany); Belka, Claus; Söhn, Matthias [Department of Radiotherapy and Radiation Oncology, Ludwig-Maximilians-Universität, Munich (Germany)

    2015-02-01

    Purpose: This study compared normal tissue complication probability (NTCP) modeling of chronic gastrointestinal toxicities following prostate cancer treatment for 2 treatment modalities. Possible factors causing discrepancies in optimal NTCP model parameters between 3-dimensional conformal radiation therapy (3D-CRT) and intensity modulated RT (IMRT) were analyzed and discussed, including the impact of patient characteristics, image guidance, toxicity scoring bias, and NTCP model limitations. Methods and Materials: Rectal wall dose-volume histograms of 1115 patients treated for prostate cancer under an adaptive radiation therapy protocol were used to model gastrointestinal toxicity grade ≥2 (according to Common Terminology Criteria for Adverse Events). A total of 457 patients were treated with 3D-CRT and 658 with IMRT. 3D-CRT patients were matched to IMRT patients based on various patient characteristics, using a propensity score–based algorithm. Parameters of the Lyman equivalent uniform dose and cut-off dose logistic regression NTCP models were estimated for the 2 matched treatment modalities and the combined group. Results: After they were matched, the 3D-CRT and IMRT groups contained 275 and 550 patients with a large discrepancy of 28.7% versus 7.8% toxicities, respectively (P<.001). For both NTCP models, optimal parameters found for the 3D-CRT groups did not fit the IMRT patients well and vice versa. Models developed for the combined data overestimated NTCP for the IMRT patients and underestimated NTCP for the 3D-CRT group. Conclusions: Our analysis did not reveal a single definitive cause for discrepancies of model parameters between 3D-CRT and IMRT. Patient characteristics and bias in toxicity scoring, as well as image guidance alone, are unlikely causes of the large discrepancy of toxicities. Whether the cause was inherent to the specific NTCP models used in this study needs to be verified by future investigations. Because IMRT is increasingly used

  4. 7 CFR 1717.159 - Applications for RUS approvals of mergers.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Applications for RUS approvals of mergers. 1717.159... ELECTRIC LOANS Mergers and Consolidations of Electric Borrowers § 1717.159 Applications for RUS approvals of mergers. If a proposed merger requires RUS approval according to RUS regulations and/or the loan...

  5. Treinamento de força com uso de correntes e potencialização pós-ativação do salto vertical Entrenamiento de fuerza con cadenas y la potenciación post-activación del salto vertical Chain resistance training and vertical jump post-activation potentiation

    Directory of Open Access Journals (Sweden)

    Jéderson Nunes

    2012-12-01

    Full Text Available A Potencialização Pós-Ativação (PPA é estratégia para melhora do desempenho com uso de carga fixa (RF, definida no ponto de falha mecânica (PFM. Por outro lado, o uso de correntes (CRT é estímulo com resistência variável (RV. Assim, objetivou-se avaliar os efeitos do CRT na altura e tempo de voo do salto vertical com contramovimento (CMJ. A partir de estudo de intervenção, 15 sujeitos foram avaliados quanto à carga máxima no agachamento (1RM e altura CMJ. Após isto, executaram três tipos de intervenções: i RF com 85% de 1RM; ii RV com 85% de 1RM posicionado no PFM (RV-TF e, iii RV com 85% de 1RM posicionado na maior extensão dos joelhos (RV-TV. Observou-se incremento do CMJ para RV-TF e RV-TV, mas não para RF. Conclui-se que houve PPA com os dois estímulos de CRT.La potenciación post-activación (PAP es estrategia para mejorar el rendimiento, utilizando una carga fija (RF, que se define en el punto de falla mecánica (PFM. Además, el uso de cadenas (CRT es estimulo con resistencia variable (RV. Así, el objetivo fue evaluar los efectos de la CRT en el salto vertical con contramovimiento (CMJ. Con estudio de intervención, 15 sujetos fueron evaluados acerca de la carga máxima en la sentadilla (1RM y altura en el CMJ. Después de eso, se realizaron tres tipos de intervenciones: i RF con el 85% de 1RM; ii RV con el 85% de 1RM en el PFM (RV-TF, y iii la RV en 1RM 85% situado en la mayor extensión de las rodillas (RV-TV. Se observó aumento de lo CMJ para RV-TF y RV-TV, pero no para la RF. Se concluye que existe PPA con los dos estímulos de RV.The Post-Activation Potentiation (PAP is a strategy to improve performance, using a fixed load (RF, defined at the sticking point (PFM. Moreover, the use of chains (CRT is an effort with variable resistance (RV. Thus, the objective was to evaluate the effects of CRT in the countermovement jump (CMJ. With an intervention study, 15 subjects were evaluated for the maximum squat load (1

  6. Factors of influence on acute skin toxicity of breast cancer patients treated with standard three-dimensional conformal radiotherapy (3D-CRT) after breast conserving surgery (BCS)

    International Nuclear Information System (INIS)

    Kraus-Tiefenbacher, Uta; Sfintizky, Andreas; Welzel, Grit; Simeonova, Anna; Sperk, Elena; Siebenlist, Kerstin; Mai, Sabine; Wenz, Frederik

    2012-01-01

    Standard 3D-CRT after BCS may cause skin toxicity with a wide range of intensity including acute effects like erythema or late effects. In order to reduce these side effects it is mandatory to identify potential factors of influence in breast cancer patients undergoing standard three-dimensional conformal radiation therapy (3D-CRT) of the breast and modern systemic therapy. Between 2006 and 2010 a total of 211 breast cancer patients (median age 52,4 years, range 24–77) after BCS consecutively treated in our institution with 3D-CRT (50 Gy whole breast photon radiotherapy followed by 16 Gy electron boost to the tumorbed) were evaluated with special focus on documented skin toxicity at the end of the 50 Gy-course. Standardized photodocumentation of the treated breast was done in each patient lying on the linac table with arms elevated. Skin toxicity was documented according to the common toxicity criteria (CTC)-score. Potential influencing factors were classified in three groups: patient-specific (smoking, age, breast size, body mass index = BMI, allergies), tumor-specific (tumorsize) and treatment-specific factors (antihormonal therapy with tamoxifen or aromatase inhibitors, chemotherapy). Uni- and multivariate statistical analyses were done using IBM SPSS version 19. After 50 Gy 3D-CRT to the whole breast 28.9% of all 211 patients had no erythema, 62.2% showed erythema grade 1 (G1) and 8.5% erythema grade 2. None of the patients had grade 3/4 (G3/4) erythema. In univariate analyses a significant influence or trend on the development of acute skin toxicities (erythema G0 versus G1 versus G2) was observed for larger breast volumes (p=0,004), smoking during radiation therapy (p=0,064) and absence of allergies (p=0,014) as well as larger tumorsize (p=0,009) and antihormonal therapy (p=0.005). Neither patient age, BMI nor choice of chemotherapy showed any significant effect on higher grade toxicity. In the multivariate analysis, factors associated with higher grade

  7. Preliminary methodological proposal for estimating environmental flows in projects approved by the ministry of environment and sustainable development (MADS), Colombia

    International Nuclear Information System (INIS)

    Pinilla Agudelo, Gabriel A; Rodriguez Sandoval, Erasmo A; Camacho Botero, Luis A

    2014-01-01

    A methodological proposal for estimating environmental flows in large projects approved by Agencia Nacional de Licencias Ambientales (ANLA) in Colombian rivers was developed. The project is the result of an agreement between the MADS and the Universidad Nacional de Colombia, Bogota (UNC). The proposed method begins with an evaluation of hydrological criteria, continues with a hydraulic and water quality validation, and follows with the determination of habitat integrity. This is an iterative process that compares conditions before and after the project construction and allows to obtain the magnitude of a monthly flow that, besides preserving the ecological functions of the river, guarantees the water uses downstream. Regarding to the biotic component, the proposal includes the establishment and monitoring of biotic integrity indices for four aquatic communities (periphyton, macro invertebrates, riparian vegetation, and fish). The effects that flow reduction may produce in the medium and long term can be assessed by these indices. We present the results of applying the methodology to several projects licensed by the MADS.

  8. Bright green phosphor, Y/sub 3/Al/sub 5-x/Ga/sub x/O/sub 12/:Tb, for projection CRT

    International Nuclear Information System (INIS)

    Ohno, K.; Abe, T.

    1987-01-01

    A remarkably improved high brightness phosphor, Y/sub 3/Al/sub 5-x/Ga/sub x/O/sub 12/:Tb (x = 0 -- 5) was developed and has been adopted for the projection CRT. The replacement of a portion of Al with Ga in YAG improved the brightness and the saturation characteristics. While the brightness of Y/sub 3/Al/sub 3/Ga/sub 2/O/sub 12/:Tb is almost the same as that of Y/sub 3/Al/sub 5/O/sub 12/:Tb at low cathode current densities, the former becomes about two times greater than the latter at high cathode current densities. The brightness of the Y/sub 3/Al/sub 5-x/Ga/sub x/O/sub 12/:Tb phosphor and its saturation characteristics are presented and compared with other green phosphors which have been used for the projection CRT

  9. A system for remote dosimetry audit of 3D-CRT, IMRT and VMAT based on lithium formate dosimetry

    International Nuclear Information System (INIS)

    Adolfsson, Emelie; Gustafsson, Håkan; Lund, Eva; Alm Carlsson, Gudrun; Olsson, Sara; Carlsson Tedgren, Åsa

    2014-01-01

    Summary: The aim of this work was to develop and test a remote end-to-end audit system using lithium formate EPR dosimeters. Four clinics were included in a pilot study, absorbed doses determined in the PTV agreed with TPS calculated doses within ±5% for 3D-CRT and ±7% (k = 1) for IMRT/VMAT dose plans

  10. Tumor Volume Reduction Rate After Preoperative Chemoradiotherapy as a Prognostic Factor in Locally Advanced Rectal Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Yeo, Seung-Gu [Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang (Korea, Republic of); Department of Radiation Oncology, Soonchunhyang University College of Medicine, Cheonan (Korea, Republic of); Kim, Dae Yong, E-mail: radiopiakim@hanmail.net [Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang (Korea, Republic of); Park, Ji Won; Oh, Jae Hwan; Kim, Sun Young; Chang, Hee Jin; Kim, Tae Hyun; Kim, Byung Chang; Sohn, Dae Kyung; Kim, Min Ju [Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang (Korea, Republic of)

    2012-02-01

    Purpose: To investigate the prognostic significance of tumor volume reduction rate (TVRR) after preoperative chemoradiotherapy (CRT) in locally advanced rectal cancer (LARC). Methods and Materials: In total, 430 primary LARC (cT3-4) patients who were treated with preoperative CRT and curative radical surgery between May 2002 and March 2008 were analyzed retrospectively. Pre- and post-CRT tumor volumes were measured using three-dimensional region-of-interest MR volumetry. Tumor volume reduction rate was determined using the equation TVRR (%) = (pre-CRT tumor volume - post-CRT tumor volume) Multiplication-Sign 100/pre-CRT tumor volume. The median follow-up period was 64 months (range, 27-99 months) for survivors. Endpoints were disease-free survival (DFS) and overall survival (OS). Results: The median TVRR was 70.2% (mean, 64.7% {+-} 22.6%; range, 0-100%). Downstaging (ypT0-2N0M0) occurred in 183 patients (42.6%). The 5-year DFS and OS rates were 77.7% and 86.3%, respectively. In the analysis that included pre-CRT and post-CRT tumor volumes and TVRR as continuous variables, only TVRR was an independent prognostic factor. Tumor volume reduction rate was categorized according to a cutoff value of 45% and included with clinicopathologic factors in the multivariate analysis; ypN status, circumferential resection margin, and TVRR were significant prognostic factors for both DFS and OS. Conclusions: Tumor volume reduction rate was a significant prognostic factor in LARC patients receiving preoperative CRT. Tumor volume reduction rate data may be useful for tailoring surgery and postoperative adjuvant therapy after preoperative CRT.

  11. Chemoradiation-induced changes in serum CEA and plasma TIMP-1 in patients with locally advanced rectal cancer

    DEFF Research Database (Denmark)

    Aldulaymi, Bahir; Christensen, Ib J; Sölétormos, György

    2010-01-01

    BACKGROUND: Preoperative biomarkers serum CEA and plasma TIMP-1 have been shown to have prognostic and predictive value in patients with colorectal cancer. The aim of the present study was to evaluate the possible impact of chemoradiotherapy (CRT) on preoperative biomarker levels in patients...... with rectal cancer. PATIENTS AND METHODS: Thirty-three patients with rectal cancer were prospectively included. The patients received CRT for 6-8 weeks. Blood samples were collected before CRT (pre-CRT) and preoperatively (post-CRT). RESULTS: Median CEA was 3.5 (range 0.6-36.1) µg/l and 2.4 (range 0.......0-10.2) µg/l (p=0.002) and median plasma TIMP-1 was 132.1 (range 77.8-342.7) µg/l and 140.0 (range 82.6-440.9) µg/l (p=0.04) in the pre- and post-CRT measurements, respectively. CONCLUSION: CRT induced a significant decrease in serum CEA and increase in plasma TIMP-1 levels. Therefore, the preoperative...

  12. 77 FR 67026 - Proposed Extension of the Approval of Information Collection Requirements

    Science.gov (United States)

    2012-11-08

    ... Information Collection: Requests to Approve Conformed Wage Classifications and Unconventional Fringe Benefit... alternative formats (Large Print, Braille, Audio Tape, or Disc), upon request, by calling (202) 693-0023 (not... request materials in alternative formats. SUPPLEMENTARY INFORMATION: I. Background The Wage and Hour...

  13. Automated and Semiautomated Segmentation of Rectal Tumor Volumes on Diffusion-Weighted MRI: Can It Replace Manual Volumetry?

    International Nuclear Information System (INIS)

    Heeswijk, Miriam M. van; Lambregts, Doenja M.J.; Griethuysen, Joost J.M. van; Oei, Stanley; Rao, Sheng-Xiang; Graaff, Carla A.M. de; Vliegen, Roy F.A.; Beets, Geerard L.; Papanikolaou, Nikos; Beets-Tan, Regina G.H.

    2016-01-01

    Purpose: Diffusion-weighted imaging (DWI) tumor volumetry is promising for rectal cancer response assessment, but an important drawback is that manual per-slice tumor delineation can be highly time consuming. This study investigated whether manual DWI-volumetry can be reproduced using a (semi)automated segmentation approach. Methods and Materials: Seventy-nine patients underwent magnetic resonance imaging (MRI) that included DWI (highest b value [b1000 or b1100]) before and after chemoradiation therapy (CRT). Tumor volumes were assessed on b1000 (or b1100) DWI before and after CRT by means of (1) automated segmentation (by 2 inexperienced readers), (2) semiautomated segmentation (manual adjustment of the volumes obtained by method 1 by 2 radiologists), and (3) manual segmentation (by 2 radiologists); this last assessment served as the reference standard. Intraclass correlation coefficients (ICC) and Dice similarity indices (DSI) were calculated to evaluate agreement between different methods and observers. Measurement times (from a radiologist's perspective) were recorded for each method. Results: Tumor volumes were not significantly different among the 3 methods, either before or after CRT (P=.08 to .92). ICCs compared to manual segmentation were 0.80 to 0.91 and 0.53 to 0.66 before and after CRT, respectively, for the automated segmentation and 0.91 to 0.97 and 0.61 to 0.75, respectively, for the semiautomated method. Interobserver agreement (ICC) pre and post CRT was 0.82 and 0.59 for automated segmentation, 0.91 and 0.73 for semiautomated segmentation, and 0.91 and 0.75 for manual segmentation, respectively. Mean DSI between the automated and semiautomated method were 0.83 and 0.58 pre-CRT and post-CRT, respectively; DSI between the automated and manual segmentation were 0.68 and 0.42 and 0.70 and 0.41 between the semiautomated and manual segmentation, respectively. Median measurement time for the radiologists was 0 seconds (pre- and post-CRT) for the

  14. Automated and Semiautomated Segmentation of Rectal Tumor Volumes on Diffusion-Weighted MRI: Can It Replace Manual Volumetry?

    Energy Technology Data Exchange (ETDEWEB)

    Heeswijk, Miriam M. van [Department of Radiology, Maastricht University Medical Centre, Maastricht (Netherlands); Department of Surgery, Maastricht University Medical Centre, Maastricht (Netherlands); Lambregts, Doenja M.J., E-mail: d.lambregts@nki.nl [Department of Radiology, Maastricht University Medical Centre, Maastricht (Netherlands); Department of Radiology, The Netherlands Cancer Institute, Amsterdam (Netherlands); Griethuysen, Joost J.M. van [GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht (Netherlands); Department of Radiology, The Netherlands Cancer Institute, Amsterdam (Netherlands); Oei, Stanley [Department of Radiology, Maastricht University Medical Centre, Maastricht (Netherlands); Rao, Sheng-Xiang [Department of Radiology, Maastricht University Medical Centre, Maastricht (Netherlands); Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai (China); Graaff, Carla A.M. de [Department of Radiology, Maastricht University Medical Centre, Maastricht (Netherlands); Vliegen, Roy F.A. [Atrium Medical Centre Parkstad/Zuyderland Medical Centre, Heerlen (Netherlands); Beets, Geerard L. [GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht (Netherlands); Department of Surgery, The Netherlands Cancer Institute, Amsterdam (Netherlands); Papanikolaou, Nikos [Laboratory of Computational Medicine, Institute of Computer Science, FORTH, Heraklion, Crete (Greece); Beets-Tan, Regina G.H. [GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht (Netherlands); Department of Radiology, The Netherlands Cancer Institute, Amsterdam (Netherlands)

    2016-03-15

    Purpose: Diffusion-weighted imaging (DWI) tumor volumetry is promising for rectal cancer response assessment, but an important drawback is that manual per-slice tumor delineation can be highly time consuming. This study investigated whether manual DWI-volumetry can be reproduced using a (semi)automated segmentation approach. Methods and Materials: Seventy-nine patients underwent magnetic resonance imaging (MRI) that included DWI (highest b value [b1000 or b1100]) before and after chemoradiation therapy (CRT). Tumor volumes were assessed on b1000 (or b1100) DWI before and after CRT by means of (1) automated segmentation (by 2 inexperienced readers), (2) semiautomated segmentation (manual adjustment of the volumes obtained by method 1 by 2 radiologists), and (3) manual segmentation (by 2 radiologists); this last assessment served as the reference standard. Intraclass correlation coefficients (ICC) and Dice similarity indices (DSI) were calculated to evaluate agreement between different methods and observers. Measurement times (from a radiologist's perspective) were recorded for each method. Results: Tumor volumes were not significantly different among the 3 methods, either before or after CRT (P=.08 to .92). ICCs compared to manual segmentation were 0.80 to 0.91 and 0.53 to 0.66 before and after CRT, respectively, for the automated segmentation and 0.91 to 0.97 and 0.61 to 0.75, respectively, for the semiautomated method. Interobserver agreement (ICC) pre and post CRT was 0.82 and 0.59 for automated segmentation, 0.91 and 0.73 for semiautomated segmentation, and 0.91 and 0.75 for manual segmentation, respectively. Mean DSI between the automated and semiautomated method were 0.83 and 0.58 pre-CRT and post-CRT, respectively; DSI between the automated and manual segmentation were 0.68 and 0.42 and 0.70 and 0.41 between the semiautomated and manual segmentation, respectively. Median measurement time for the radiologists was 0 seconds (pre- and post-CRT) for the

  15. Automated and Semiautomated Segmentation of Rectal Tumor Volumes on Diffusion-Weighted MRI: Can It Replace Manual Volumetry?

    Science.gov (United States)

    van Heeswijk, Miriam M; Lambregts, Doenja M J; van Griethuysen, Joost J M; Oei, Stanley; Rao, Sheng-Xiang; de Graaff, Carla A M; Vliegen, Roy F A; Beets, Geerard L; Papanikolaou, Nikos; Beets-Tan, Regina G H

    2016-03-15

    Diffusion-weighted imaging (DWI) tumor volumetry is promising for rectal cancer response assessment, but an important drawback is that manual per-slice tumor delineation can be highly time consuming. This study investigated whether manual DWI-volumetry can be reproduced using a (semi)automated segmentation approach. Seventy-nine patients underwent magnetic resonance imaging (MRI) that included DWI (highest b value [b1000 or b1100]) before and after chemoradiation therapy (CRT). Tumor volumes were assessed on b1000 (or b1100) DWI before and after CRT by means of (1) automated segmentation (by 2 inexperienced readers), (2) semiautomated segmentation (manual adjustment of the volumes obtained by method 1 by 2 radiologists), and (3) manual segmentation (by 2 radiologists); this last assessment served as the reference standard. Intraclass correlation coefficients (ICC) and Dice similarity indices (DSI) were calculated to evaluate agreement between different methods and observers. Measurement times (from a radiologist's perspective) were recorded for each method. Tumor volumes were not significantly different among the 3 methods, either before or after CRT (P=.08 to .92). ICCs compared to manual segmentation were 0.80 to 0.91 and 0.53 to 0.66 before and after CRT, respectively, for the automated segmentation and 0.91 to 0.97 and 0.61 to 0.75, respectively, for the semiautomated method. Interobserver agreement (ICC) pre and post CRT was 0.82 and 0.59 for automated segmentation, 0.91 and 0.73 for semiautomated segmentation, and 0.91 and 0.75 for manual segmentation, respectively. Mean DSI between the automated and semiautomated method were 0.83 and 0.58 pre-CRT and post-CRT, respectively; DSI between the automated and manual segmentation were 0.68 and 0.42 and 0.70 and 0.41 between the semiautomated and manual segmentation, respectively. Median measurement time for the radiologists was 0 seconds (pre- and post-CRT) for the automated method, 41 to 69 seconds (pre-CRT) and

  16. 76 FR 34091 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Science.gov (United States)

    2011-06-10

    ... managing its financial risks and protect consumers from lender noncompliance with FHA rules and regulations... Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and Noncompliance Reporting by FHA Approved Lenders AGENCY: Office of the Assistant Secretary for Housing, HUD...

  17. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

    Science.gov (United States)

    Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

    2015-01-01

    In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

  18. 78 FR 2878 - Approval and Promulgation of Implementation Plans; Georgia: New Source Review-Prevention of...

    Science.gov (United States)

    2013-01-14

    ... incorrect version of the proposed rulemaking. DATES: The proposed rule published January 2, 2013, is... Deterioration'' to approve changes to Georgia's SIP-approved regulations entitled ``Air Quality Control Rule 391-3-.1.'' The proposed rule version published in the Federal Register on January 2, 2013, was an...

  19. Proposal for the delineation of the nodal CTV in the node-positive and the post-operative neck

    International Nuclear Information System (INIS)

    Gregoire, Vincent; Eisbruch, Avraham; Hamoir, Marc; Levendag, Peter

    2006-01-01

    Background and purpose: In 2003, a panel of experts published a set of consensus guidelines regarding the delineation of the neck node levels (Radiother Oncol, 2003; 69: 227-36). These recommendations were applicable for the node-negative and the N1-neck, but were found too restrictive for the node-positive and the post-operative neck. Patients and methods: In this framework, using the previous recommendations as a backbone, new guidelines have been proposed taking into account the specificities of the node-positive and the post-operative neck. Results: Inclusion of the retrostyloid space cranially and the supra-clavicular fossa caudally is proposed in case of neck nodes (defined radiologically or on the surgical specimen) located in levels II, and IV or Vb, respectively. When extra-capsular rupture is suspected (on imaging) or demonstrated on the pathological specimen, adjacent muscles should also be included in the CTV. For node(s) located at the boundary between contiguous levels (e.g. levels II and Ib), these two levels should be delineated. In the post-operative setting, the entire 'surgical bed' should be included. Last, the retropharyngeal space should be delineated in case of positive neck from pharyngeal tumors. Conclusions: The objective of the manuscript is to give a comprehensive description of the new set of guidelines for CTV delineation in the node-positive neck and the post-operative neck, with a complementary atlas of the new anatomical structures to be included

  20. A critical assessment of the Hong Kong Government's proposed post-2008 regulatory regime for local electricity utilities

    International Nuclear Information System (INIS)

    Woo, Chi-Keung; Horowitz, Ira; Tishler, Asher

    2006-01-01

    In December 2005, the Hong Kong Government issued a 'Consultation Paper on Future Development of the Electricity Markets in Hong Kong: Stage II Consultation,' proposing a post-2008 regulatory regime upon the expiration of the existing regulatory contract between the Hong Kong Government and each of the two local electricity utilities. We assess the proposal using the criteria of safe, reliable, and environmentally friendly service at the lowest rates that will allow the utilities reasonable returns on their investments. We caution that if fully adopted, the highly risky proposal may lead to less-reliable service without the compensating benefits to the environment

  1. CONSERVATIVE TREATMENT IN LOCALLY AND LOCALLY-ADVANCED PROSTATE CANCER USING CONFORMAL RADIOTHERAPY

    Directory of Open Access Journals (Sweden)

    Tkachev Sergey Ivanovich

    2013-01-01

    Full Text Available The combination of androgen deprivation and radiotherapy increase the probability of diseases full regresses and survival rate. Modern technical and technological opportunities of 3D CRT allow to increase total dose to prostate up to 72-76Gy vs. radiotherapy of 66-70Gy. In this study we compare the rates of post radiation toxicity and the efficiency of treatment for the patients receiving conventional radiotherapy and 3D CRT. The use of 3D CRT has not only result to increase of 10-years recurrence free survival rate from 74% (I grope to 86,5% (II grope, р=0,01, but also to increase of 10-years overall survival, 70% versus 78,4% (р=0,04. The proposed version of conformal 3D CRT radiation therapy made ​​it possible compared to conventional 2D RT radiation therapy by increasing SOD radiation to the tumor, accuracy and compliance with the quality assurance of radiation therapy significantly reduce rates of recurrence and significantly increase the performance of 10-year overall and disease-free survival.

  2. Extraction of lead from waste CRT funnel glass by generating lead sulfide - An approach for electronic waste management.

    Science.gov (United States)

    Hu, Biao; Hui, Wenlong

    2017-09-01

    Waste cathode ray tube (CRT) funnel glass is the key and difficult points in waste electrical and electronic equipment (WEEE) disposal. In this paper, a novel and effective process for the detoxification and reutilization of waste CRT funnel glass was developed by generating lead sulfide precipitate via a high-temperature melting process. The central function in this process was the generation of lead sulfide, which gathered at the bottom of the crucible and was then separated from the slag. Sodium carbonate was used as a flux and reaction agent, and sodium sulfide was used as a precipitating agent. The experimental results revealed that the lead sulfide recovery rate initially increased with an increase in the amount of added sodium carbonate, the amount of sodium sulfide, the temperature, and the holding time and then reached an equilibrium value. The maximum lead sulfide recovery rate was approximately 93%, at the optimum sodium carbonate level, sodium sulfide level, temperature, and holding time of 25%, 8%, 1200°C, and 2h, respectively. The glass slag can be made into sodium and potassium silicate by hydrolysis in an environmental and economical process. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. SU-E-J-254: Evaluating the Role of Mid-Treatment and Post-Treatment FDG-PET/CT in Predicting Progression-Free Survival and Distant Metastasis of Anal Cancer Patients Treated with Chemoradiotherapy

    International Nuclear Information System (INIS)

    Zhang, H; Wang, J; Chuong, M; D’Souza, W; Choi, W; Lu, W; Latifi, K; Hoffe, S; Moros, E; Saeed, Nadia; Tan, S; Shridhar, R

    2015-01-01

    Purpose: To evaluate the role of mid-treatment and post-treatment FDG-PET/CT in predicting progression-free survival (PFS) and distant metastasis (DM) of anal cancer patients treated with chemoradiotherapy (CRT). Methods: 17 anal cancer patients treated with CRT were retrospectively studied. The median prescription dose was 56 Gy (range, 50–62.5 Gy). All patients underwent FDG-PET/CT scans before and after CRT. 16 of the 17 patients had an additional FDG-PET/CT image at 3–5 weeks into the treatment (denoted as mid-treatment FDG-PET/CT). 750 features were extracted from these three sets of scans, which included both traditional PET/CT measures (SUVmax, SUVpeak, tumor diameters, etc.) and spatialtemporal PET/CT features (comprehensively quantify a tumor’s FDG uptake intensity and distribution, spatial variation (texture), geometric property and their temporal changes relative to baseline). 26 clinical parameters (age, gender, TNM stage, histology, GTV dose, etc.) were also analyzed. Advanced analytics including methods to select an optimal set of predictors and a model selection engine, which identifies the most accurate machine learning algorithm for predictive analysis was developed. Results: Comparing baseline + mid-treatment PET/CT set to baseline + posttreatment PET/CT set, 14 predictors were selected from each feature group. Same three clinical parameters (tumor size, T stage and whether 5-FU was held during any cycle of chemotherapy) and two traditional measures (pre- CRT SUVmin and SUVmedian) were selected by both predictor groups. Different mix of spatial-temporal PET/CT features was selected. Using the 14 predictors and Naive Bayes, mid-treatment PET/CT set achieved 87.5% accuracy (2 PFS patients misclassified, all local recurrence and DM patients correctly classified). Post-treatment PET/CT set achieved 94.0% accuracy (all PFS and DM patients correctly predicted, 1 local recurrence patient misclassified) with logistic regression, neural network or

  4. SU-E-J-254: Evaluating the Role of Mid-Treatment and Post-Treatment FDG-PET/CT in Predicting Progression-Free Survival and Distant Metastasis of Anal Cancer Patients Treated with Chemoradiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Zhang, H; Wang, J; Chuong, M; D’Souza, W; Choi, W; Lu, W [University of Maryland School of Medicine, Baltimore, MD (United States); Latifi, K; Hoffe, S; Moros, E [Moffitt Cancer Center, Tampa, FL (United States); Saeed, Nadia [Brwon University, Providence, RI (United States); Tan, S [Huazhong University of Science & Technology, Wuhan (China); Shridhar, R [Florida Hospital, Orlando, FL (United States)

    2015-06-15

    Purpose: To evaluate the role of mid-treatment and post-treatment FDG-PET/CT in predicting progression-free survival (PFS) and distant metastasis (DM) of anal cancer patients treated with chemoradiotherapy (CRT). Methods: 17 anal cancer patients treated with CRT were retrospectively studied. The median prescription dose was 56 Gy (range, 50–62.5 Gy). All patients underwent FDG-PET/CT scans before and after CRT. 16 of the 17 patients had an additional FDG-PET/CT image at 3–5 weeks into the treatment (denoted as mid-treatment FDG-PET/CT). 750 features were extracted from these three sets of scans, which included both traditional PET/CT measures (SUVmax, SUVpeak, tumor diameters, etc.) and spatialtemporal PET/CT features (comprehensively quantify a tumor’s FDG uptake intensity and distribution, spatial variation (texture), geometric property and their temporal changes relative to baseline). 26 clinical parameters (age, gender, TNM stage, histology, GTV dose, etc.) were also analyzed. Advanced analytics including methods to select an optimal set of predictors and a model selection engine, which identifies the most accurate machine learning algorithm for predictive analysis was developed. Results: Comparing baseline + mid-treatment PET/CT set to baseline + posttreatment PET/CT set, 14 predictors were selected from each feature group. Same three clinical parameters (tumor size, T stage and whether 5-FU was held during any cycle of chemotherapy) and two traditional measures (pre- CRT SUVmin and SUVmedian) were selected by both predictor groups. Different mix of spatial-temporal PET/CT features was selected. Using the 14 predictors and Naive Bayes, mid-treatment PET/CT set achieved 87.5% accuracy (2 PFS patients misclassified, all local recurrence and DM patients correctly classified). Post-treatment PET/CT set achieved 94.0% accuracy (all PFS and DM patients correctly predicted, 1 local recurrence patient misclassified) with logistic regression, neural network or

  5. 32 CFR 736.7 - Approval by the Attorney General.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 5 2010-07-01 2010-07-01 false Approval by the Attorney General. 736.7 Section..., PATENTS, AND CONTRACTS DISPOSITION OF PROPERTY § 736.7 Approval by the Attorney General. Prior to the... inventions, irrespective of cost, the Department of the Navy must notify the Attorney General of the proposed...

  6. FDG-PET status following chemoradiotherapy provides high management impact and powerful prognostic stratification in oesophageal cancer

    International Nuclear Information System (INIS)

    Duong, Cuong P.; Thomas, Robert J.S.; Hicks, Rodney J.; Drummond, Elizabeth; Weih, LeAnn; Leong, Trevor; Michael, Michael

    2006-01-01

    The purpose of this study was to evaluate the impact of FDG-PET following chemoradiotherapy (CRT) on treatment planning and survival in patients with oesophageal cancer (OC). Fifty-three consecutive OC patients had a post-treatment PET scan to evaluate tumour response to CRT prior to possible surgery. Baseline pre-CRT PET was performed in 33 patients. Prospectively recorded post-CRT management plans were compared with post-PET treatment. High impact was defined as a change in treatment intent or modality. Survival was analysed using the Kaplan-Meier product limit method and Cox proportional hazards regression model. After completion of CRT, 23/53 patients (43%) achieved complete metabolic response (CMR), as compared with only four (8%) with complete response on computed tomography. High PET impact was observed in 19 patients (36%). CMR was strongly predictive of survival (p<0.008) on multivariate analysis. CMR patients in whom resection was not performed had comparable survival to those (CMR and non-CMR) who underwent resection. The use of post-treatment FDG-PET for assessment of tumour response after CRT changed the clinical management of more than one-third of OC patients. CMR status as assessed by PET powerfully stratified prognosis. Even in the absence of a baseline study, normalisation of uptake at all sites of known tumoral involvement carries a good medium-term prognosis. (orig.)

  7. Prediction of pathologic staging with magnetic resonance imaging after preoperative chemoradiotherapy in rectal cancer: pooled analysis of KROG 10-01 and 11-02.

    Science.gov (United States)

    Lee, Jong Hoon; Jang, Hong Seok; Kim, Jun-Gi; Lee, Myung Ah; Kim, Dae Yong; Kim, Tae Hyun; Oh, Jae Hwan; Park, Sung Chan; Kim, Sun Young; Baek, Ji Yeon; Park, Hee Chul; Kim, Hee Cheol; Nam, Taek-Keun; Chie, Eui Kyu; Jung, Ji-Han; Oh, Seong Taek

    2014-10-01

    The reported overall accuracy of MRI in predicting the pathologic stage of nonirradiated rectal cancer is high. However, the role of MRI in restaging rectal tumors after neoadjuvant CRT is contentious. Thus, we evaluate the accuracy of restaging magnetic resonance imaging (MRI) for rectal cancer patients who receive preoperative chemoradiotherapy (CRT). We analyzed 150 patients with locally advanced rectal cancer (T3-4N0-2) who had received preoperative CRT. Pre-CRT MRI was performed for local tumor and nodal staging. All patients underwent restaging MRI followed by total mesorectal excision after the end of radiotherapy. The primary endpoint of the present study was to estimate the accuracy of post-CRT MRI as compared with pathologic staging. Pathologic T classification matched the post-CRT MRI findings in 97 (64.7%) of 150 patients. 36 (24.0%) of 150 patients were overstaged in T classification, and the concordance degree was moderate (k=0.33, prectal cancer patients who received preoperative CRT. The diagnostic accuracy of restaging MRI is relatively high in rectal cancer patients who achieved clinical downstaging after CRT. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  8. 77 FR 75915 - Review and Approval of Projects

    Science.gov (United States)

    2012-12-26

    ... SUSQUEHANNA RIVER BASIN COMMISSION 18 CFR Part 806 Review and Approval of Projects AGENCY... document contains proposed rules that would amend the project review regulations of the Susquehanna River... set forth in this proposed rulemaking is to make further modifications to the Commission's project...

  9. SU-C-BRA-04: Use of Esophageal Wall Thickness in Evaluation of the Response to Chemoradiation Therapy for Esophageal Cancer

    International Nuclear Information System (INIS)

    Wang, J; Kligerman, S; Lu, W; Kang, M

    2015-01-01

    Purpose: To quantitatively evaluate the esophageal cancer response to chemoradiation therapy (CRT) by measuring the esophageal wall thickness in CT. Method: Two datasets were used in this study. The first dataset is composed of CT scans of 15 esophageal cancer patients and 15 normal controls. The second dataset is composed of 20 esophageal cancer patients who underwent PET/CT scans before (Pre-CRT) and after CRT (Post-CRT). We first segmented the esophagus using a multi-atlas-based algorithm. The esophageal wall thickness was then computed, on each slice, as the equivalent circle radius of the segmented esophagus excluding the lumen. To evaluate the changes of wall thickness, we computed the standard deviation (SD), coefficient of variation (COV, SD/Mean), and flatness [(Max–Min)/Mean] of wall thickness along the entire esophagus. Results: For the first dataset, the mean wall thickness of cancer patients and normal controls were 6.35 mm and 6.03 mm, respectively. The mean SD, COV, and flatness of the wall thickness were 2.59, 0.21, and 1.27 for the cancer patients and 1.99, 0.16, and 1.13 for normal controls. Statistically significant differences (p < 0.05) were identified in SD and flatness. For the second dataset, the mean wall thickness of pre-CRT and post-CRT patients was 7.13 mm and 6.84 mm, respectively. The mean SD, COV, and flatness were 1.81, 0.26, and 1.06 for pre-CRT and 1.69, 0.26, and 1.06 for post-CRT. Statistically significant difference was not identified for these measurements. Current results are based on the entire esophagus. We believe significant differences between pre- and post-CRT scans could be obtained, if we conduct the measurements at tumor sites. Conclusion: Results show thicker wall thickness in pre-CRT scans and differences in wall thickness changes between normal and abnormal esophagus. This demonstrated the potential of esophageal wall thickness as a marker in the tumor CRT response evaluation. This work was supported in part by

  10. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

    Directory of Open Access Journals (Sweden)

    Ross JS

    2015-05-01

    Full Text Available Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%, nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillance

  11. What "likes" have got to do with it: Exposure to peers' alcohol-related posts and perceptions of injunctive drinking norms.

    Science.gov (United States)

    Boyle, Sarah C; Smith, Daniel J; Earle, Andrew M; LaBrie, Joseph W

    2018-01-01

    Examine 1) whether observed social reinforcements (i.e., "likes") received by peers' alcohol-related social media posts are related to first-year college students' perceptions of peer approval for risky drinking behaviors; and 2) whether associations are moderated by students' alcohol use status. First-year university students (N = 296) completed an online survey in September, 2014. Participants reported their own alcohol use, friends' alcohol use, perceptions of the typical student's approval for risky drinking, and ranked 10 types of social media posts in terms of the relative numbers of "likes" received when posted by peers. Observed social reinforcement (i.e., "likes") for peers' alcohol-related posts predicted perceptions of peer approval for risky drinking behaviors among non-drinking students, but not drinking students. For first-year college students who have not yet initiated drinking, observing peers' alcohol-related posts to receive abundant "likes" may increase perceptions of peer approval for risky drinking.

  12. Sequential neoadjuvant chemoradiotherapy (CRT) followed by curative surgery vs. primary surgery alone for resectable, non-metastasized pancreatic adenocarcinoma: NEOPA- a randomized multicenter phase III study (NCT01900327, DRKS00003893, ISRCTN82191749)

    International Nuclear Information System (INIS)

    Tachezy, Michael; Yekebas, Emre; Gebauer, Florian; Petersen, Cordula; Arnold, Dirk; Trepel, Martin; Wegscheider, Karl; Schafhausen, Phillipe; Bockhorn, Maximilian; Izbicki, Jakob Robert

    2014-01-01

    Median OS after surgery in curative intent for non-metastasized pancreas cancer ranges under study conditions from 17.9 months to 23.6 months. Tumor recurrence occurs locally, at distant sites (liver, peritoneum, lungs), or both. Observational and autopsy series report local recurrence rates of up to 87% even after potentially “curative” R0 resection. To achieve better local control, neoadjuvant CRT has been suggested for preoperative tumour downsizing, to elevate the likelihood of curative, margin-negative R0 resection and to increase the OS rate. However, controlled, randomized trials addressing the impact of neoadjuvant CRT survival do not exist. The underlying hypothesis of this randomized, two-armed, open-label, multicenter, phase III trial is that neoadjuvant CRT increases the three-year overall survival by 12% compared to patients undergoing upfront surgery for resectable pancreatic cancer. A rigorous, standardized technique of histopathologically handling Whipple specimens will be applied at all participating centers. Overall, 410 patients (n = 205 in each study arm) will be enrolled in the trial, taking into regard an expected drop out rate of 7% and allocated either to receive neoadjuvant CRT prior to surgery or to undergo surgery alone. Circumferential resection margin status, i.e. R0 and R1 rates, respectively, surgical resectability rate, local and distant disease-free and global survival, and first site of tumor recurrence constitute further essential endpoints of the trial. For the first time, the NEOPA study investigates the impact of neoadjuvant CRT on survival of resectable pancreas head cancer in a prospectively randomized manner. The results of the study have the potential to change substantially the treatment regimen of pancreas cancer. Clinical Trial gov:http://www.clinicaltrials.gov/show/NCT01900327; Clinical Trial gov:http://drks-neu.uniklinik-freiburg.de/drks w eb/navigate.do?navigationId; Clinical Trial gov

  13. Number of patients studied prior to approval of new medicines

    DEFF Research Database (Denmark)

    Duijnhoven, Ruben G; Straus, Sabine M J M; Raine, June M

    2013-01-01

    length of time), whereas 67 (79.8%) of the medicines met the criteria for 12-mo patient exposure (at least 100 participants studied for 12 mo). CONCLUSIONS: For medicines intended for chronic use, the number of patients studied before marketing is insufficient to evaluate safety and long-term efficacy....... Both safety and efficacy require continued study after approval. New epidemiologic tools and legislative actions necessitate a review of the requirements for the number of patients studied prior to approval, particularly for chronic use, and adequate use of post-marketing studies. Please see later...

  14. Details of recurrence sites after elective nodal irradiation (ENI) using 3D-conformal radiotherapy (3D-CRT) combined with chemotherapy for thoracic esophageal squamous cell carcinoma--a retrospective analysis.

    Science.gov (United States)

    Yamashita, Hideomi; Okuma, Kae; Wakui, Reiko; Kobayashi-Shibata, Shino; Ohtomo, Kuni; Nakagawa, Keiichi

    2011-02-01

    To describe patterns of recurrence of elective nodal irradiation (ENI) in definitive chemoradiotherapy (CRT) for thoracic esophageal squamous cell carcinoma (SqCC) using 3D-conformal radiotherapy. One hundred and twenty-six consecutive patients with stages I-IVB thoracic esophageal SqCC newly diagnosed between June 2000 and July 2009 and treated with 3D-CRT in our institution were recruited from our database. Definitive CRT consisted of two cycles of nedaplatin/5FU repeated every 4 weeks, with concurrent radiation therapy of 50-50.4 Gy in 25-28 fractions. Until completion, radiotherapy was delivered to the N1 and M1a lymph nodes as ENI in addition to gross tumor volume. All 126 patients were included in this analysis, and their tumors were staged as follows: T1/T2/T3/T4, 28/18/54/26; N0/N1, 50/76; M0/M1a/M1b, 91/5/30. The mean follow-up period for the 63 surviving patients was 28.3 (±22.8) months. Eighty-seven patients (69%) achieved complete response (CR) without any residual tumor at least once after completion of CRT. After achieving CR, each of 40 patients experienced failures (local=20 and distant=20) and no patient experienced elective nodal failure without having any other site of recurrence. The upper thoracic esophageal carcinoma showed significantly more (34%) relapses at the local site than the middle (9%) or lower thoracic (11%) carcinomas. The 2-year and 3-year overall survival was 56% and 43%, respectively. The 1-year, 2-year and 3-year disease-free survival was 46%, 38% and 33%, respectively. In CRT for esophageal SqCC, ENI was effective for preventing regional nodal failure. The upper thoracic esophageal carcinomas had significantly more local recurrences than the middle or lower thoracic sites. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  15. Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dregan Alex

    2012-10-01

    Full Text Available Abstract Background The purpose of this research is to develop and evaluate methods for conducting pragmatic cluster randomized trials in a primary care electronic database. The proposal describes one application, in a less frequent chronic condition of public health importance, secondary prevention of stroke. A related protocol in antibiotic prescribing was reported previously. Methods/Design The study aims to implement a cluster randomized trial (CRT using the electronic patient records of the General Practice Research Database (GPRD as a sampling frame and data source. The specific objective of the trial is to evaluate the effectiveness of a computer-delivered intervention at enhancing the delivery of stroke secondary prevention in primary care. GPRD family practices will be allocated to the intervention or usual care. The intervention promotes the use of electronic prompts to support adherence with the recommendations of the UK Intercollegiate Stroke Working Party and NICE guidelines for the secondary prevention of stroke in primary care. Primary outcome measure will be the difference in systolic blood pressure between intervention and control trial arms at 12-month follow-up. Secondary outcomes will be differences in serum cholesterol, prescribing of antihypertensive drugs, statins, and antiplatelet therapy. The intervention will continue for 12 months. Information on the utilization of the decision-support tools will also be analyzed. Discussion The CRT will investigate the effectiveness of using a computer-delivered intervention to reduce the risk of stroke recurrence following a first stroke event. The study will provide methodological guidance on the implementation of CRTs in electronic databases in primary care. Trial registration Current Controlled Trials ISRCTN35701810

  16. Post electrical or lightning injury syndrome: a proposal for an American Psychiatric Association's Diagnostic and Statistical Manual formulation with implications for treatment.

    Science.gov (United States)

    Andrews, Christopher J; Reisner, Andrew D; Cooper, Mary Ann

    2017-09-01

    In the past, victims of electrical and lightning injuries have been assessed in a manner lacking a systematic formulation, and against ad hoc criteria, particularly in the area of neuropsychological disability. In this manner patients have, for example, only been partially treated, been poorly or incorrectly diagnosed, and have been denied the full benefit of compensation for their injuries. This paper contains a proposal for diagnostic criteria particularly for the neuropsychological aspects of the post injury syndrome. It pays attention to widely published consistent descriptions of the syndrome, and a new cluster analysis of post electrical injury patients. It formulates a proposal which could be incorporated into future editions of the American Psychiatric Association's Diagnostic and Statistical Manual (DSM). The major neuropsychological consequences include neurocognitive dysfunction, and memory subgroup dysfunction, with ongoing consequences, and sometimes including progressive or delayed psychiatric, cognitive, and/or neurological symptoms. The proposed diagnostic criteria insist on a demonstrated context for the injury, both specifying the shock circumstance, and also physical consequences. It allows for a certain delay in onset of symptoms. It recognizes exclusory conditions. The outcome is a proposal for a DSM classification for the post electrical or lightning injury syndrome. This proposal is considered important for grounding patient treatment, and for further treatment trials. Options for treatment in electrical or lightning injury are summarised, and future trials are foreshadowed.

  17. MRI and Diffusion-weighted MRI Volumetry for Identification of Complete Tumor Responders After Preoperative Chemoradiotherapy in Patients With Rectal Cancer: A Bi-institutional Validation Study.

    Science.gov (United States)

    Lambregts, Doenja M J; Rao, Sheng-Xiang; Sassen, Sander; Martens, Milou H; Heijnen, Luc A; Buijsen, Jeroen; Sosef, Meindert; Beets, Geerard L; Vliegen, Roy A; Beets-Tan, Regina G H

    2015-12-01

    Retrospective single-center studies have shown that diffusion-weighted magnetic resonance imaging (DWI) is promising for identification of patients with rectal cancer with a complete tumor response after neoadjuvant chemoradiotherapy (CRT), using certain volumetric thresholds. This study aims to validate the diagnostic value of these volume thresholds in a larger, independent, and bi-institutional patient cohort. A total of 112 patients with locally advanced rectal cancer (2 centers) treated with a long course of CRT were enrolled. Patients underwent standard T2W-magnetic resonance imaging and DWI, both pre- and post-CRT. Two experienced readers independently determined pre-CRT and post-CRT tumor volumes (cm) on T2W-magnetic resonance image and diffusion-weighted magnetic resonance image by means of freehand tumor delineation. Tumor volume reduction rates (Δvolume) were calculated. Previously determined T2W and DWI threshold values for prevolume, postvolume, and Δvolume were tested to "prospectively" assess their respective diagnostic value in discriminating patients with a complete tumor response from patients with residual tumor. Twenty patients had a complete response. Using the average measurements between the 2 readers, areas under the curve for the pre-/post-/Δvolumes was 0.73/0.82/0.78 for T2W-magnetic resonance imaging and 0.77/0.92/0.86 for DWI, respectively. For T2W-volumetry, sensitivity and specificity using the predefined volume thresholds were 55% and 74% for pre-, 60% and 89% for post-, and 60% and 86% for Δvolume. For DWI volumetry, sensitivity and specificity were 65% and 76% for pre-, 70% and 98% for post-, and 70% and 93% for Δvolume. Previously established DWI volume thresholds can be reproduced with good results. Post-CRT DWI volumetry offers the best results for the detection of patients with a complete response after CRT with an area under the curve of 0.92, sensitivity of 70%, and specificity of 98%.

  18. Process-based project proposal risk management

    Directory of Open Access Journals (Sweden)

    Alok Kumar

    2016-12-01

    Full Text Available We all are aware of the organizational omnipresence. Projects within the organizations are ubiquitous too. Projects achieve their goals successfully if they are planned, scheduled, controlled and implemented well. The project lifecycle of initiating, planning, scheduling, controlling and implementing are very well-planned by project managers and the organizations. Successful projects have well-developed risk management plans to deal with situations impacting projects. Like any other organisation, a university does try to access funds for different purposes too. For such organisations, running a project is not the issue, rather getting a project proposal approved to fund a project is the key. Project proposal processing is done by the nodal office in every organisation. Usually, these nodal offices help in administration and submission of a project proposal for accessing funds. Seldom are these nodal project offices within the organizations facilitate a project proposal approval by proactively reaching out to the project managers. And as project managers prepare project proposals, little or no attention is made to prepare a project proposal risk plan so as to maximise project acquisition. Risk plans are submitted while preparing proposals but these risk plans cater to a requirement to address actual projects upon approval. Hence, a risk management plan for project proposal is either missing or very little effort is made to treat the risks inherent in project acquisition. This paper is an integral attempt to highlight the importance of risk treatment for project proposal stage as an extremely important step to preparing the risk management plan made for projects corresponding to their lifecycle phases. Several tools and techniques have been proposed in the paper to help and guide either the project owner (proposer or the main organisational unit responsible for project management. Development of tools and techniques to further enhance project

  19. 76 FR 76399 - Agency Information Collection Activities; Proposed Renewal of Several Currently Approved...

    Science.gov (United States)

    2011-12-07

    ... ethical conduct of completed research that involved human subjects when such research is submitted to EPA... approved Information Collection Request (ICR) to the Office of Management and Budget (OMB). The ICRs are... total time, effort, or financial resources expended by persons to generate, maintain, retain, or...

  20. Auditing the process of ethics approval for Master's degrees at a ...

    African Journals Online (AJOL)

    Objective. This study audited the process of ethics approval for Master's research at the Nelson R Mandela School of Medicine, Durban, KwaZulu-Natal, South Africa. Methods. After obtaining the appropriate ethical approval, all the correspondence surrounding each Master's proposal for the year 2010 was reviewed.

  1. The predictive and prognostic potential of plasma telomerase reverse transcriptase (TERT) RNA in rectal cancer patients

    Science.gov (United States)

    Rampazzo, Enrica; Del Bianco, Paola; Bertorelle, Roberta; Boso, Caterina; Perin, Alessandro; Spiro, Giovanna; Bergamo, Francesca; Belluco, Claudio; Buonadonna, Angela; Palazzari, Elisa; Leonardi, Sara; De Paoli, Antonino; Pucciarelli, Salvatore; De Rossi, Anita

    2018-01-01

    Background: Preoperative chemoradiotherapy (CRT) followed by surgery is the standard care for locally advanced rectal cancer, but tumour response to CRT and disease outcome are variable. The current study aimed to investigate the effectiveness of plasma telomerase reverse transcriptase (TERT) levels in predicting tumour response and clinical outcome. Methods: 176 rectal cancer patients were included. Plasma samples were collected at baseline (before CRT=T0), 2 weeks after CRT was initiated (T1), post-CRT and before surgery (T2), and 4–8 months after surgery (T3) time points. Plasma TERT mRNA levels and total cell-free RNA were determined using real-time PCR. Results: Plasma levels of TERT were significantly lower at T2 (P<0.0001) in responders than in non-responders. Post-CRT TERT levels and the differences between pre- and post-CRT TERT levels independently predicted tumour response, and the prediction model had an area under curve of 0.80 (95% confidence interval (CI) 0.73–0.87). Multiple analysis demonstrated that patients with detectable TERT levels at T2 and T3 time points had a risk of disease progression 2.13 (95% CI 1.10–4.11)-fold and 4.55 (95% CI 1.48–13.95)-fold higher, respectively, than those with undetectable plasma TERT levels. Conclusions: Plasma TERT levels are independent markers of tumour response and are prognostic of disease progression in rectal cancer patients who undergo neoadjuvant therapy. PMID:29449673

  2. Optimized volumetric modulated arc therapy versus 3D-CRT for early stage mediastinal Hodgkin lymphoma without axillary involvement: a comparison of second cancers and heart disease risk.

    Science.gov (United States)

    Filippi, Andrea Riccardo; Ragona, Riccardo; Piva, Cristina; Scafa, Davide; Fiandra, Christian; Fusella, Marco; Giglioli, Francesca Romana; Lohr, Frank; Ricardi, Umberto

    2015-05-01

    The purpose of this study was to evaluate the risks of second cancers and cardiovascular diseases associated with an optimized volumetric modulated arc therapy (VMAT) planning solution in a selected cohort of stage I/II Hodgkin lymphoma (HL) patients treated with either involved-node or involved-site radiation therapy in comparison with 3-dimensional conformal radiation therapy (3D-CRT). Thirty-eight patients (13 males and 25 females) were included. Disease extent was mediastinum alone (n=8, 21.1%); mediastinum plus unilateral neck (n=19, 50%); mediastinum plus bilateral neck (n=11, 29.9%). Prescription dose was 30 Gy in 2-Gy fractions. Only 5 patients had mediastinal bulky disease at diagnosis (13.1%). Anteroposterior 3D-CRT was compared with a multiarc optimized VMAT solution. Lung, breast, and thyroid cancer risks were estimated by calculating a lifetime attributable risk (LAR), with a LAR ratio (LAR(VMAT)-to-LAR(3D-CRT)) as a comparative measure. Cardiac toxicity risks were estimated by calculating absolute excess risk (AER). The LAR ratio favored 3D-CRT for lung cancer induction risk in mediastinal alone (P=.004) and mediastinal plus unilateral neck (P=.02) presentations. LAR ratio for breast cancer was lower for VMAT in mediastinal plus bilateral neck presentations (P=.02), without differences for other sites. For thyroid cancer, no significant differences were observed, regardless of anatomical presentation. A significantly lower AER of cardiac (P=.038) and valvular diseases (Pdisease extent. In a cohort of patients with favorable characteristics in terms of disease extent at diagnosis (large prevalence of nonbulky presentations without axillary involvement), optimized VMAT reduced heart disease risk with comparable risks of thyroid and breast cancer, with an increase in lung cancer induction probability. The results are however strongly influenced by the different anatomical presentations, supporting an individualized approach. Copyright © 2015 Elsevier

  3. Has 3-D conformal radiotherapy (3D CRT) improved the local tumour control for stage I non-small cell lung cancer?

    International Nuclear Information System (INIS)

    Lagerwaard, Frank J.; Senan, Suresh; Meerbeeck, Jan P. van; Graveland, Wilfried J.

    2002-01-01

    Aims and background: The high local failure rates observed after radiotherapy in stage I non-small cell lung cancer (NSCLC) may be improved by the use of 3-dimensional conformal radiotherapy (3D CRT). Materials and methods: The case-records of 113 patients who were treated with curative 3D CRT between 1991 and 1999 were analysed. No elective nodal irradiation was performed, and doses of 60 Gy or more, in once-daily fractions of between 2 and 3 Gy, were prescribed. Results: The median actuarial survival of patients was 20 months, with 1-, 3- and 5-year survival of 71, 25 and 12%, respectively. Local disease progression was the cause of death in 30% of patients, and 22% patients died from distant metastases. Grade 2-3 acute radiation pneumonitis (SWOG) was observed in 6.2% of patients. The median actuarial local progression-free survival (LPFS) was 27 months, with 85 and 43% of patients free from local progression at 1 and 3 years, respectively. Endobronchial tumour extension significantly influenced LPFS, both on univariate (P=0.023) and multivariate analysis (P=0.023). The median actuarial cause-specific survival (CSS) was 19 months, and the respective 1- and 3-year rates were 72 and 30%. Multivariate analysis showed T2 classification (P=0.017) and the presence of endobronchial tumour extension (P=0.029) to be adverse prognostic factors for CSS. On multivariate analysis, T-stage significantly correlated with distant failure (P=0.005). Conclusions: Local failure rates remain substantial despite the use of 3D CRT for stage I NSCLC. Additional improvements in local control can come about with the use of radiation dose escalation and approaches to address the problem of tumour mobility

  4. A series of structurally simple chloroquine chemosensitizing dibemethin derivatives that inhibit chloroquine transport by PfCRT.

    Science.gov (United States)

    Zishiri, Vincent K; Hunter, Roger; Smith, Peter J; Taylor, Dale; Summers, Robert; Kirk, Kiaran; Martin, Rowena E; Egan, Timothy J

    2011-05-01

    A series of 12 new dibemethin (N-benzyl-N-methyl-1-phenylmethanamine) derivatives bearing an N-aminomethyl group attached to the one phenyl ring and an H, Cl, OCH3 or N(CH3)2 group on the other have been synthesized. These compounds all showed strong chloroquine chemosensitizing activity, comparable to verapamil, when present at 1 μM in an in vitro culture of the chloroquine-resistant W2 strain of the human malaria parasite, Plasmodium falciparum. Their N-formylated derivatives also exhibited resistance-reversing activity, but only at substantially higher IC10 concentrations. A number of the dibemethin derivatives were shown to inhibit chloroquine transport via the parasite's 'chloroquine resistance transporter' (PfCRT) in a Xenopus laevis oocyte expression system. The reduced resistance-reversing activity of the formylated compounds relative to their free amine counterparts can probably be ascribed to two factors: decreased accumulation of the formylated dibemethins within the parasite's internal digestive vacuole (believed to be the site of action of chloroquine), and a reduced ability to inhibit PfCRT. The resistance-reversing activity of the compounds described here demonstrates that the amino group need not be attached to the two aromatic rings via a three or four carbon chain as has been suggested by previous QSAR studies. These compounds may be useful as potential side chains for attaching to a 4,7-dichloroquinoline group in order to generate new resistance-reversing chloroquine analogues with inherent antimalarial activity. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

  5. Full-scale mark II CRT program data report no. 7

    International Nuclear Information System (INIS)

    Kukita, Yutaka; Namatame, Ken; Yamamoto, Nobuo; Takeshita, Isao; Shiba, Masayoshi

    1980-03-01

    The Full-Scale Mark II CRT (Containment Response Test) Program was initiated in 1977 to provide a data base for evaluation of the LOCA hydrodynamic loads in the BWR Mark II pressure suppression system. The test facility is 1/18 in volume and has a wetwell which is a full-scale replica of one 20 0 -sector of that of a reference Mark II. This report documents test data obtained from TEST 3102, which is a large (200 mm) water break test performed on June 29, 1979. The test was performed for a supernominal break area (approx. 160% of the scaled break area for a postulated double-ended break in the recirculation line) to obtain vent steam mass fluxes ranging up to the maximum design value of the actual plants. Before the initiation of the test more than 90% of the drywell air was replaced by steam and transferred into wetwell airspace to reduce the air content in the vent flow during the test. Because of this pre-test treatment (so-called prepurging) the test data obtained for high- and intermediate-steam-flux condensation oscillations are believed to be to a high degree on conservative side. (author)

  6. Programming the diagnosis logic by means of the conversational graphic input to the CRT display device

    International Nuclear Information System (INIS)

    Kato, A.; Tsuji, H.; Okamoto, Y.

    1984-01-01

    A plant diagnostic method using Cause Consequence Tree (CCT) has been recognized as a powerful means to identify and analyze plant fault events. The off-line support program called the 'CCT diagram editor' was developed and it could generate the computer object program by inputting the CCT diagram itself using the CRT display, tablet and key-board just as the computer aided design (CAD). The CCT diagram editor has improved the problems of the programming error, difficulty of correction or modification and productivity of the program. The system can be used also for safety analysis of nuclear power plants. (author)

  7. Simple measurements on diffusion-weighted MR imaging for assessment of complete response to neoadjuvant chemoradiotherapy in locally advanced rectal cancer

    Energy Technology Data Exchange (ETDEWEB)

    Cai, Pei-Qiang; Wu, Yao-Pan; Xie, Chuan-Miao; Wu, Pei-Hong [Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou (China); Department of Medical Imaging and Interventional Radiology, Guangzhou (China); An, Xin [Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou (China); Department of Medical Oncology, Guangzhou (China); Qiu, Xue; Kong, Ling-Heng; Liu, Guo-Chen; Pan, Zhi-Zhong; Ding, Pei-Rong [Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou (China); Sun Yat-sen University Cancer Center, Department of Colorectal Surgery, Guangzhou (China)

    2014-11-15

    To determine diagnostic performance of simple measurements on diffusion-weighted MR imaging (DWI) for assessment of complete tumour response (CR) after neoadjuvant chemoradiotherapy (CRT) in patients with locally advanced rectal cancer (LARC) by signal intensity (SI) and apparent diffusion coefficient (ADC) measurements. Sixty-five patients with LARC who underwent neoadjuvant CRT and subsequent surgery were included. Patients underwent pre-CRT and post-CRT 3.0 T MRI. Regions of interest of the highest brightness SI were included in the tumour volume on post-CRT DWI to calculate the SI{sub lesion}, rSI, ADC{sub lesion} and rADC; diagnostic performance was compared by using the receiver operating characteristic (ROC) curves. In order to validate the accuracy and reproducibility of the current strategy, the same procedure was reproduced in 80 patients with LARC at 1.5 T MRI. Areas under the ROC curve for identification of a CR, based on SI{sub lesion}, rSI, ADC{sub lesion}, and rADC, respectively, were 0.86, 0.94, 0.66, and 0.71 at 3.0 T MRI, and 0.92, 0.91, 0.64, and 0.61 at 1.5 T MRI. Post-CRT DWI SI{sub lesion} and rSI provided high diagnostic performance in assessing CR and were significantly more accurate than ADC{sub lesion}, and rADC at 3.0 T MRI and 1.5 T MRI. (orig.)

  8. Finding dose-volume constraints to reduce late rectal toxicity following 3D-conformal radiotherapy (3D-CRT) of prostate cancer

    International Nuclear Information System (INIS)

    Greco, Carlo; Mazzetta, Chiara; Cattani, Federica; Tosi, Giampiero; Castiglioni, Simona; Fodor, Andrei; Orecchia, Roberto

    2003-01-01

    Background and purpose: The rectum is known to display a dose-volume effect following high-dose 3D-conformal radiotherapy (3D-CRT). The aim of the study is to search for significant dose-volume combinations with the specific treatment technique and patient set-up currently used in our institution. Patients and methods: We retrospectively analyzed the dose-volume histograms (DVH) of 135 patients with stage T1b-T3b prostate cancer treated consecutively with 3D-CRT between 1996 and 2000 to a total dose of 76 Gy. The median follow-up was 28 months (range 12-62). All late rectal complications were scored using RTOG criteria. Time to late toxicity was assessed using the Kaplan-Meyer method. The association between variables at baseline and ≥2 rectal toxicity was tested using χ 2 test or Fisher's exact test. A multivariate analysis using logistic regression was performed. Results: Late rectal toxicity grade ≥2 was observed in 24 of the 135 patients (17.8%). A 'grey area' of increased risk has been identified. Average DVHs of the bleeding and non-bleeding patients were generated. The area under the percent volume DVH for the rectum of the bleeding patients was significantly higher than that of patients without late rectal toxicity. On multivariate analysis the correlation between the high risk DVHs and late rectal bleeding was confirmed. Conclusions: The present analysis confirms the role of the rectal DVH as a tool to discriminate patients undergoing high-dose 3D-CRT into a low and a high risk of developing late rectal bleeding. Based on our own results and taking into account the data published in the literature, we have been able to establish new dose-volume constraints for treatment planning: if possible, the percentage of rectal volume exposed to 40, 50, 60, 72 and 76 Gy should be limited to 60, 50, 25, 15 and 5%, respectively

  9. Group cognitive remediation therapy for younger adolescents with anorexia nervosa: a feasibility study in a Japanese sample.

    Science.gov (United States)

    Kuge, Rie; Lang, Katie; Yokota, Ayano; Kodama, Shoko; Morino, Yuriko; Nakazato, Michiko; Shimizu, Eiji

    2017-07-25

    Cognitive remediation therapy (CRT) aims to increase patients' cognitive flexibility by practicing new ways of thinking as well as facilitating bigger picture thinking, supporting patients with relevant tasks and encouraging an awareness of their own thinking styles. CRT has been applied in the treatment of adult anorexia nervosa (AN), and has been shown to be effective and acceptable. In adolescents, CRT has been piloted on both individual and group format. However, no studies are published in CRT for adolescents with AN in a Japanese sample. The objectives of this study were to assess the feasibility, to estimate effect sizes for the purpose of designing a larger study, and to assess the acceptability of a CRT group for younger adolescents with AN in a Japanese sample. Group CRT interventions were carried out with a total of seven adolescents with AN. Neuropsychological and psychological assessments (motivation, self-efficacy and depression) were administered before and after the group intervention. The participants completed worksheets (documents of participants' thinking about their thinking style and the relation of the skills that they learnt through each session to real-life) and questionnaires after the group. There were small effect sizes differences between the part of the pre and post neuropsychological tests and the pre and post ability to change (motivation). There were medium effect sizes differences between the pre and post depressive symptoms and importance to change (motivation). There was a large effect size shown between the pre and post weights. All participants were able to reflect on their own thinking styles, such as having difficulty with changing feelings and the tendency to focus on details in real-life. Adolescents' feedback was positive, and the rate of dropout was low. CRT groups could be feasible and acceptable for younger adolescents with AN in a Japanese sample. Trial registration UMIN No. 000020623. Registered 18 January 2016.

  10. Diffusion-weighted imaging: Apparent diffusion coefficient histogram analysis for detecting pathologic complete response to chemoradiotherapy in locally advanced rectal cancer.

    Science.gov (United States)

    Choi, Moon Hyung; Oh, Soon Nam; Rha, Sung Eun; Choi, Joon-Il; Lee, Sung Hak; Jang, Hong Seok; Kim, Jun-Gi; Grimm, Robert; Son, Yohan

    2016-07-01

    To investigate the usefulness of apparent diffusion coefficient (ADC) values derived from histogram analysis of the whole rectal cancer as a quantitative parameter to evaluate pathologic complete response (pCR) on preoperative magnetic resonance imaging (MRI). We enrolled a total of 86 consecutive patients who had undergone surgery for rectal cancer after neoadjuvant chemoradiotherapy (CRT) at our institution between July 2012 and November 2014. Two radiologists who were blinded to the final pathological results reviewed post-CRT MRI to evaluate tumor stage. Quantitative image analysis was performed using T2 -weighted and diffusion-weighted images independently by two radiologists using dedicated software that performed histogram analysis to assess the distribution of ADC in the whole tumor. After surgery, 16 patients were confirmed to have achieved pCR (18.6%). All parameters from pre- and post-CRT ADC histogram showed good or excellent agreement between two readers. The minimum, 10th, 25th, 50th, and 75th percentile and mean ADC from post-CRT ADC histogram were significantly higher in the pCR group than in the non-pCR group for both readers. The 25th percentile value from ADC histogram in post-CRT MRI had the best diagnostic performance for detecting pCR, with an area under the receiver operating characteristic curve of 0.796. Low percentile values derived from the ADC histogram analysis of rectal cancer on MRI after CRT showed a significant difference between pCR and non-pCR groups, demonstrating the utility of the ADC value as a quantitative and objective marker to evaluate complete pathologic response to preoperative CRT in rectal cancer. J. Magn. Reson. Imaging 2016;44:212-220. © 2015 Wiley Periodicals, Inc.

  11. Towards an equitable post-2012 climate agreement. Climate development network proposals

    International Nuclear Information System (INIS)

    Creach, Morgane; Mathy, Sandrine; Moussa Na Abou, Mamouda; Nanasta, Djimingue; Angerand, Sylvain; Faraco, Benoit; Chetaille, Anne

    2008-11-01

    After a presentation of the 'Climate and Development' international network, the first part of this report discusses how equity is at the heart of the definition of future commitments to reduce emissions (discussion of the possibility of a contribution from all countries to avoid global warming, comments on the Bali mandate, discussion of the different meaning and implications of equity). The second part discusses a specific stake with respect to climate: combating deforestation and forest degradation (overview of what is at stake, question of REDD financing - REDD stands for Reducing emissions from deforestation and forest degradation, reinforcement of public policies and governance to implement REDD policies). The third part discusses the issue of adaptation: limited significance given to adaptation until now, description of the framework of negotiations on adaptation in the Bali mandate and in the Nairobi work programme, overview of proposals from the states, recommendations by the Climate Development network). The fourth chapter highlights the extreme importance of technology transfer: overview of technologies needed for emission reduction and for adaptation, provisions of the convention and protocol on this issue, overview of what must be done. The last chapter outlines financing reduction and adaptation as a key stake for the post-2012 agreement: overview of the financial stakes (mechanisms, current state of finances), finance needs for mitigation and technology transfer, to combat deforestation, to support adaptation to the impacts of climate change, proposals made by different countries

  12. Comparison of right ventricular septal pacing and right ventricular apical pacing in patients receiving cardiac resynchronization therapy defibrillators: the SEPTAL CRT Study

    Science.gov (United States)

    Leclercq, Christophe; Sadoul, Nicolas; Mont, Lluis; Defaye, Pascal; Osca, Joaquim; Mouton, Elisabeth; Isnard, Richard; Habib, Gilbert; Zamorano, Jose; Derumeaux, Genevieve; Fernandez-Lozano, Ignacio; Dupuis, Jean-Marc; Rouleau, Frédéric; Tassin, Aude; Bordachar, Pierre; Clémenty, Jacques; Lafitte, Stephane; Ploux, Sylvan; Reant, Patricia; Ritter, Philippe; Defaye, Pascal; Jacon, Peggy; Mondesert, Blandine; Saunier, Carole; Vautrin, Estelle; Kacet, Salem; Guedon-Moreau, Laurence; Klug, Didier; Kouakam, Claude; Marechaux, Sylvestre; Marquie, Christelle; Polge, Anne Sophie; Richardson, Marjorie; Chevallier, Philippe; De Breyne, Brigitte; Lotek, Marcin M.; Nonin, Emilie; Pineau, Julien; Deharo, Jean-Claude; Bastard, Emilie; Franceschi, Frédéric; Habib, Gilbert; Jego, Christophe; Peyrouse, Eric; Prevot, Sebastien; Saint-Joseph, Hôpital; Bremondy, Michel; Faure, Jacques; Ferracci, Ange; Lefevre, Jean; Pisapia, Andre; Davy, Jean-Marc; Cransac, Frederic; Cung, Tien Tri; Georger, Frederic; Pasquie, Jean-Luc; Raczka, Franck; Sportouch-Dukhan, Catherine; Sadoul, Nicolas; Blangy, Hugues; Bruntz, Jean-François; Freysz, Luc; Groben, Laurent; Huttin, Olivier; Bammert, Antoine; Burban, Marc; Cebron, Jean-Pierre; Gras, Daniel; Frank, Robert; Duthoit, Guillaume; Hidden-Lucet, Françoise; Himbert, Caroline; Isnard, Richard; Lacotte, Jérôme; Pousset, Françoise; Zerah, Thierry; Leclercq, Christophe; Bellouin, Annaïk; Crocq, Christophe; Deplace, Christian; Donal, Erwan; Hamon, Cécile; Mabo, Philippe; Romain, Olivier; Solnon, Aude; Frederic, Anselme; Bauer, Fabrice; Bernard, Mathieu; Godin, Benedicte; Kurtz, Baptiste; Savoure, Arnaud; Copie, Xavier; Lascault, Gilles; Paziaud, Olivier; Piot, Olivier; Touche, Thierry; Delay, Toulouse Marc; Chilon, Talia; Detis, Nicolas; Duparc, Alexandre; Hebrard, Aurélien; Massabuau, Pierre; Maury, Philippe; Mondoly, Pierre; Rumeau, Philippe; Pasteur, Clinique; Boveda, Serge; Adrover, Laurence; Combes, Nicolas; Deplagne, Antoine; Marco-Baertich, Isabelle; Fondard, Olivier; Martínez, Juan Gabriel; Ibañez Criado, José Luis; Ortuño, Diego; Mont, Lluis; Berruezo, Antonio; Eduard, Belu; Martín, Ana; Merschon, Franco M.; Sitges, Marta; Tolosana, José María; Vidal, Bárbara; Hebron, H. Valle; i Mitjans, Angel Moya; Rodriguez, Oscar Alcalde; Rodriguez Palomares, José Fernando; Rivas, Nuria; Teixidó, Gisela; de Hierro, H. Puerta; Lozano, Ignacio Fernández; Ruiz Bautista, Maria Lorena; Castro, Victor; Cavero, Miguel Angel; Gutierrez, Carlos; Ros, Natalia; de la Victoria, H. Virgen; Alzueta Rodriguez, Francisco Javier; Cabrera, Fernando; Cordero, Alberto Barrera; Peña, José Luis; de Valme Sevilla, H.; Gonzáles, Juan Lealdel Ojo; Garcia Medina, Mª Dolores; Jiménez, Ricardo Pavón; Villagomez, David; de la Salud Toledo, H. Virgen; Castellanos Martinez, Eduardo; Alcalá, Juan; Maicas, Carolina; Arias Palomares, Miguel Angel; Puchol, Alberto; Valencia, H. La Fé; OscaAsensi, Joaquim; Carmona, Anastasio Quesada; De Carranza, Mª José Sancho-Tello; De Ros, José Olagüe; Pareja, Enrique Castro; Pérez, Oscar Cano; Saez, Ana Osa; Hortega, H. Rio; Guilarte, Benito Herreros; Muñoz San Jose, Juan Francisco; Pérez Sanz, Teresa Myriam; Logeart, Damien; Gil, Maria Lopez; Leclercq, Christophe; Lozano, Ignacio Fernandez; de Hierro, H. Puerta; Derumeaux, Genevieve

    2016-01-01

    Abstract Aims Cardiac resynchronization therapy (CRT) is a recommended treatment of heart failure (HF) patients with depressed left ventricular ejection fraction and wide QRS. The optimal right ventricular (RV) lead position being a matter of debate, we sought to examine whether RV septal (RVS) pacing was not inferior to RV apical (RVA) pacing on left ventricular reverse remodelling in patients receiving a CRT-defibrillator. Methods and results Patients (n = 263, age = 63.4 ± 9.5 years) were randomly assigned in a 1:1 ratio to RVS (n = 131) vs. RVA (n = 132) pacing. Left ventricular end-systolic volume (LVESV) reduction between baseline and 6 months was not different between the two groups (−25.3 ± 39.4 mL in RVS group vs. −29.3 ± 44.5 mL in RVA group, P = 0.79). Right ventricular septal pacing was not non-inferior (primary endpoint) to RVA pacing with regard to LVESV reduction (average difference = −4.06 mL; P = 0.006 with a −20 mL non-inferiority margin). The percentage of ‘echo-responders’ defined by LVESV reduction >15% between baseline and 6 months was similar in both groups (50%) with no difference in the time to first HF hospitalization or death (P = 0.532). Procedural or device-related serious adverse events occurred in 68 patients (RVS = 37) with no difference between the two groups (P = 0.401). Conclusion This study demonstrates that septal RV pacing in CRT is non-inferior to apical RV pacing for LV reverse remodelling at 6 months with no difference in the clinical outcome. No recommendation for optimal RV lead position can hence be drawn from this study. ClinicalTrials. gov number NCT 00833352. PMID:26374852

  13. Application of probabilistic fiber-tracking method of MR imaging to measure impact of cranial irradiation on structural brain connectivity in children treated for medulloblastoma

    Science.gov (United States)

    Duncan, Elizabeth C.; Reddick, Wilburn E.; Glass, John O.; Hyun, Jung Won; Ji, Qing; Li, Yimei; Gajjar, Amar

    2016-03-01

    We applied a modified probabilistic fiber-tracking method for the extraction of fiber pathways to quantify decreased white matter integrity as a surrogate of structural loss in connectivity due to cranial radiation therapy (CRT) as treatment for pediatric medulloblastoma. Thirty subjects were examined (n=8 average-risk, n=22 high-risk) and the groups did not differ significantly in age at examination. The pathway analysis created a structural connectome focused on sub-networks within the central executive network (CEN) for comparison between baseline and post-CRT scans and for comparison between standard and high dose CRT. A paired-wise comparison of the connectivity between baseline and post-CRT scans showed the irradiation did have a significant detrimental impact on white matter integrity (decreased fractional anisotropy (FA) and decreased axial diffusivity (AX)) in most of the CEN sub-networks. Group comparisons of the change in the connectivity revealed that patients receiving high dose CRT experienced significant AX decreases in all sub-networks while the patients receiving standard dose CRT had relatively stable AX measures across time. This study on pediatric patients with medulloblastoma demonstrated the utility of this method to identify specific sub-networks within the developing brain affected by CRT.

  14. Drug therapy for recurrence after chemoradiotherapy

    International Nuclear Information System (INIS)

    Okano, Susumu

    2016-01-01

    Most head and neck cancer patients are advanced stage when first diagnosed and about half of them receive chemoradiotherapy (CRT) because the cancer is unresectable or there is hope of functional preservation. In subsequent treatment for recurrence after CRT, many of them receive chemotherapy with or without reirradiation. There are three situations when chemotherapy is used for recurrence after CRT: 1. Re-chemoradiotherapy (Re-CRT) in the adjuvant setting after salvage surgery 2. Re-CRT for cases who cannot receive salvage surgery. 3. Chemotherapy for cases who cannot receive salvage surgery or Re-CRT. In the first situation, Re-CRT is expected to yield a better outcome, but there is concern about severe adverse events, so special care in selecting patients is required. In the second situation, there are some negative comments about Re-CRT, and so cases must be judged individually. In the third situation, there are some choices of treatment, but EBM is based on past large clinical trials, so the treatment based on a guideline or guidance is recommended. Recently, new drugs have been invented and approved in the world, though their cost is increasing rapidly. It is necessary to provide the best treatment that also takes cost-effectiveness into consideration. (author)

  15. Significance of ERBB2 overexpression in therapeutic resistance and cancer-specific survival in muscle-invasive bladder cancer patients treated with chemoradiation-based selective bladder-sparing approach.

    Science.gov (United States)

    Inoue, Masaharu; Koga, Fumitaka; Yoshida, Soichiro; Tamura, Tomoki; Fujii, Yasuhisa; Ito, Eisaku; Kihara, Kazunori

    2014-10-01

    To investigate the associations of ERBB 2 overexpression with chemoradiation therapy (CRT) resistance and cancer-specific survival (CSS) in muscle-invasive bladder cancer (MIBC) patients treated with the CRT-based bladder-sparing protocol. From 1997 to 2012, 201 patients with cT2-4aN0M0 bladder cancer were treated with CRT (40 Gy with concurrent cisplatin) following transurethral resection of bladder tumor (TURBT). Basically, patients with tumors that showed good CRT response and were amenable to segmental resection underwent partial cystectomy (PC) with pelvic lymph node dissection for bladder preservation; otherwise, radical cystectomy (RC) was recommended. Included in this study were 119 patients in whom TURBT specimens were available for immunohistochemical analysis of ERBB 2 expression. Following CRT, 30 and 65 patients underwent PC or RC, respectively; the remaining 24 patients did not undergo cystectomy. Tumors were defined as CRT-resistant when patients did not achieve complete response after CRT. Associations of ERBB 2 overexpression with CRT resistance and CSS were evaluated. CRT resistance was observed clinically in 56% (67 of 119 patients) and pathologically (in cystectomy specimens) in 55% (52 of 95 patients). ERBB 2 overexpression was observed in 45 patients (38%). On multivariate analysis, ERBB 2 overexpression was an independent predictor for CRT resistance clinically (odds ratio, 3.6; P=.002) and pathologically (odds ratio, 2.9; P=.031). ERBB 2 overexpression was associated with shorter CSS (5-year CSS rates, 56% vs 87% for the ERBB 2 overexpression group vs the others; P=.001). ERBB 2 overexpression was also an independent risk factor for bladder cancer death at all time points of our bladder-sparing protocol (pre-CRT, post-CRT, and post-cystectomy). ERBB 2 overexpression appears relevant to CRT resistance and unfavorable CSS in MIBC patients treated with the CRT-based bladder-sparing protocol. ERBB 2-targeting treatment may improve the outcomes

  16. Significance of ERBB2 Overexpression in Therapeutic Resistance and Cancer-Specific Survival in Muscle-Invasive Bladder Cancer Patients Treated With Chemoradiation-Based Selective Bladder-Sparing Approach

    International Nuclear Information System (INIS)

    Inoue, Masaharu; Koga, Fumitaka; Yoshida, Soichiro; Tamura, Tomoki; Fujii, Yasuhisa; Ito, Eisaku; Kihara, Kazunori

    2014-01-01

    Purpose: To investigate the associations of ERBB 2 overexpression with chemoradiation therapy (CRT) resistance and cancer-specific survival (CSS) in muscle-invasive bladder cancer (MIBC) patients treated with the CRT-based bladder-sparing protocol. Methods and Materials: From 1997 to 2012, 201 patients with cT2-4aN0M0 bladder cancer were treated with CRT (40 Gy with concurrent cisplatin) following transurethral resection of bladder tumor (TURBT). Basically, patients with tumors that showed good CRT response and were amenable to segmental resection underwent partial cystectomy (PC) with pelvic lymph node dissection for bladder preservation; otherwise, radical cystectomy (RC) was recommended. Included in this study were 119 patients in whom TURBT specimens were available for immunohistochemical analysis of ERBB 2 expression. Following CRT, 30 and 65 patients underwent PC or RC, respectively; the remaining 24 patients did not undergo cystectomy. Tumors were defined as CRT-resistant when patients did not achieve complete response after CRT. Associations of ERBB 2 overexpression with CRT resistance and CSS were evaluated. Results: CRT resistance was observed clinically in 56% (67 of 119 patients) and pathologically (in cystectomy specimens) in 55% (52 of 95 patients). ERBB 2 overexpression was observed in 45 patients (38%). On multivariate analysis, ERBB 2 overexpression was an independent predictor for CRT resistance clinically (odds ratio, 3.6; P=.002) and pathologically (odds ratio, 2.9; P=.031). ERBB 2 overexpression was associated with shorter CSS (5-year CSS rates, 56% vs 87% for the ERBB 2 overexpression group vs the others; P=.001). ERBB 2 overexpression was also an independent risk factor for bladder cancer death at all time points of our bladder-sparing protocol (pre-CRT, post-CRT, and post-cystectomy). Conclusions: ERBB 2 overexpression appears relevant to CRT resistance and unfavorable CSS in MIBC patients treated with the CRT-based bladder

  17. Priority of the genus name Clostridium Prazmowski 1880 (Approved Lists 1980) vs Sarcina Goodsir 1842 (Approved Lists 1980) and the creation of the illegitimate combinations Clostridium maximum (Lindner 1888) Lawson and Rainey 2016 and Clostridium ventriculi (Goodsir 1842) Lawson and Rainey 2016 that may not be used.

    Science.gov (United States)

    Tindall, B J

    2016-11-01

    In a recent publication that attempts to deal with the growing problem of taxa being added to the genus Clostridium that are outside of Clostridium (16S rRNA) group I, a solution is proposed that seeks to limit the genus Clostridium Prazmowski 1880 (Approved Lists 1980) to a small number of species 'related' to the type species, Clostridium butyricum Prazmowski 1880 (Approved Lists 1980). It has been proposed that this genus should also include members of the genus Sarcina Goodsir 1842 (Approved Lists 1980), Sarcinamaxima Lindner 1888 (Approved Lists 1980) and Sarcinaventriculi Goodsir 1842 (Approved Lists 1980), the latter being the nomenclatural type of the genus Sarcina Goodsir 1842 (Approved Lists 1980). In making proposals to treat the genus name Sarcina Goodsir 1842 (Approved Lists 1980) as a synonym of ClostridiumPrazmowski 1880 (Approved Lists 1980), reference is made to the wording of the International Code of Nomenclature of Bacteria. However, while that wording is factually correct, other parts of the Code are relevant to this issue and clearly indicate that the proposed course of action is not sanctioned by texts that have not been directly made reference to. Rather than avoiding confusion it has been contributed to, and it is necessary to document where the problems lie.

  18. 78 FR 694 - Proposed Extension of Approval of Information Collection; Comment Request-Testing and...

    Science.gov (United States)

    2013-01-04

    ... ignition of mattresses, 16 CFR part 1632. The Open- Flame standard is intended to reduce unreasonable risks... may be introduced into commerce. The Office of Management and Budget (OMB) previously approved the... suppliers, and confirmation test records, if establishments choose to pool a prototype. This documentation...

  19. 10 CFR 725.15 - Requirements for approval of applications.

    Science.gov (United States)

    2010-01-01

    ... Secret Restricted Data in C-91, Nuclear Reactors for Rocket Propulsion, will be approved only if the... propulsion and is directly engaged in or proposes to engage in a substantial research and development program in such field of work; or (ii) Is engaged in or proposes to engage in a substantial study program in...

  20. Optimized Volumetric Modulated Arc Therapy Versus 3D-CRT for Early Stage Mediastinal Hodgkin Lymphoma Without Axillary Involvement: A Comparison of Second Cancers and Heart Disease Risk

    Energy Technology Data Exchange (ETDEWEB)

    Filippi, Andrea Riccardo, E-mail: andreariccardo.filippi@unito.it [Department of Oncology, Radiation Oncology, University of Torino, Torino (Italy); Ragona, Riccardo; Piva, Cristina; Scafa, Davide; Fiandra, Christian [Department of Oncology, Radiation Oncology, University of Torino, Torino (Italy); Fusella, Marco; Giglioli, Francesca Romana [Medical Physics, AOU Città della Salute e della Scienza Hospital, Torino (Italy); Lohr, Frank [Department of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Mannheim (Germany); Ricardi, Umberto [Department of Oncology, Radiation Oncology, University of Torino, Torino (Italy)

    2015-05-01

    Purpose: The purpose of this study was to evaluate the risks of second cancers and cardiovascular diseases associated with an optimized volumetric modulated arc therapy (VMAT) planning solution in a selected cohort of stage I/II Hodgkin lymphoma (HL) patients treated with either involved-node or involved-site radiation therapy in comparison with 3-dimensional conformal radiation therapy (3D-CRT). Methods and Materials: Thirty-eight patients (13 males and 25 females) were included. Disease extent was mediastinum alone (n=8, 21.1%); mediastinum plus unilateral neck (n=19, 50%); mediastinum plus bilateral neck (n=11, 29.9%). Prescription dose was 30 Gy in 2-Gy fractions. Only 5 patients had mediastinal bulky disease at diagnosis (13.1%). Anteroposterior 3D-CRT was compared with a multiarc optimized VMAT solution. Lung, breast, and thyroid cancer risks were estimated by calculating a lifetime attributable risk (LAR), with a LAR ratio (LAR{sub VMAT}-to-LAR{sub 3D-CRT}) as a comparative measure. Cardiac toxicity risks were estimated by calculating absolute excess risk (AER). Results: The LAR ratio favored 3D-CRT for lung cancer induction risk in mediastinal alone (P=.004) and mediastinal plus unilateral neck (P=.02) presentations. LAR ratio for breast cancer was lower for VMAT in mediastinal plus bilateral neck presentations (P=.02), without differences for other sites. For thyroid cancer, no significant differences were observed, regardless of anatomical presentation. A significantly lower AER of cardiac (P=.038) and valvular diseases (P<.0001) was observed for VMAT regardless of disease extent. Conclusions: In a cohort of patients with favorable characteristics in terms of disease extent at diagnosis (large prevalence of nonbulky presentations without axillary involvement), optimized VMAT reduced heart disease risk with comparable risks of thyroid and breast cancer, with an increase in lung cancer induction probability. The results are however strongly influenced by

  1. 7 CFR 4274.332 - Post award requirements.

    Science.gov (United States)

    2010-01-01

    ..., justifies different amounts, a reserve for bad debts of 6 percent of outstanding loans must be accumulated... Program (IRP) § 4274.332 Post award requirements. (a) Applicability. Intermediaries receiving loans under this program shall be governed by these regulations, the loan agreement, the approved work plan...

  2. The Effect of Post Traumatic Stress Disorder on Military Leadership: An Historical Perspective

    Science.gov (United States)

    2011-05-19

    Post Traumatic Stress Disorder ( PTSD ) on military leadership. For over twenty years, the United States Army has used the Be...Introduction Multiple deployment cycles to Iraq and Afghanistan combat zones and the increase in Post - Traumatic Stress Disorder ( PTSD ) have resulted...Approved for Public Release; Distribution is Unlimited The Effect of Post Traumatic Stress Disorder on Military Leadership: An

  3. 77 FR 60085 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year...

    Science.gov (United States)

    2012-10-02

    ... Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year Inventory for the... proposing to approve the fine particulate matter (PM 2.5 ) 2002 base year emissions inventory portion of the... Quality Standard (NAAQS) SIP. EPA is proposing to approve the 2002 base year PM 2.5 emissions inventory...

  4. 77 FR 36292 - Proposed Collection, Comments Requested: FBI National Academy Level III Evaluation; FBI National...

    Science.gov (United States)

    2012-06-18

    ... Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995...: Approval of a reinstated collection. 2. Title of the Forms: FBI National Academy Post-Course Questionnaire... FBI National Academy. These surveys have been developed that will measure the effectiveness of...

  5. Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.

    Science.gov (United States)

    Jokura, Yoji; Yano, Kazuo; Yamato, Masayuki

    2018-02-01

    Legislation for expedited-approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited-approval pathways, and obligations to collect and report post-marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time-limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre- or post-marketing clinical data. Expedited-approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post-marketing study for conditional and time-limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited-approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. Copyright © 2017 The Authors. Tissue

  6. 77 FR 60094 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year...

    Science.gov (United States)

    2012-10-02

    ... Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year Inventory for the... proposing to approve the fine particulate matter (PM 2.5 ) 2002 base year emissions inventory portion of the... Standard (NAAQS) SIP. EPA is proposing to approve the 2002 base year PM 2.5 emissions inventory for the...

  7. 77 FR 60087 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year...

    Science.gov (United States)

    2012-10-02

    ... Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year Inventory for the... proposing to approve the fine particulate matter (PM 2.5 ) 2002 base year emissions inventory portion of the... National Ambient Air Quality Standard (NAAQS) SIP. EPA is proposing to approve the 2002 base year PM 2.5...

  8. Proposed modifications to the RCRA post-closure permit for the Bear Creek Hydrogeologic Regime at the US Department of Energy Y-12 Plant, Oak Ridge, Tennessee

    International Nuclear Information System (INIS)

    1997-05-01

    This report presents proposed modifications to several conditions of the Resource Conservation and Recovery Act (RCRA) Post-Closure Permit (PCP) for the Bear Creek Hydrogeologic Regime (BCHR). These permit conditions define the requirements for RCRA post-closure corrective action groundwater monitoring at the S-3 Ponds, the Oil Landfarm, and the Bear Creek Burial Grounds (units A, C-West, and Walk-in Pits). Modification of these PCP conditions is requested to: (1) clarify the planned integration of RCRA post-closure corrective action groundwater monitoring with the monitoring program to be established in the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Record of Decision (ROD) for the Bear Creek Valley (BCV) Watershed, (2) revise several of the current technical requirements for groundwater monitoring based on implementation of the RCRA post-closure corrective action monitoring program during 1996, and (3) update applicable technical procedures with revised versions recently issued by the Y-12 Plant Groundwater Protection Program (GWPP). With these modifications, the Y-12 Plant will continue to meet the full intent of all regulatory obligations for post-closure care of these facilities. Section 2.0 provides the technical justification for each proposed permit modification. The proposed changes to permit language are provided in Section 3.0 (S-3 Ponds), Section 4.0 (Oil Landfarm), and Section 5.0 (Bear Creek Burial Grounds). Sections 6.0 and 7.0 reference updated and revised procedures for groundwater sampling, and monitoring well plugging and abandonment, respectively. Appendix A includes all proposed revisions to the PCP Attachments

  9. Proposed modifications to the RCRA post-closure permit for the Bear Creek Hydrogeologic Regime at the US Department of Energy Y-12 Plant, Oak Ridge, Tennessee

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-05-01

    This report presents proposed modifications to several conditions of the Resource Conservation and Recovery Act (RCRA) Post-Closure Permit (PCP) for the Bear Creek Hydrogeologic Regime (BCHR). These permit conditions define the requirements for RCRA post-closure corrective action groundwater monitoring at the S-3 Ponds, the Oil Landfarm, and the Bear Creek Burial Grounds (units A, C-West, and Walk-in Pits). Modification of these PCP conditions is requested to: (1) clarify the planned integration of RCRA post-closure corrective action groundwater monitoring with the monitoring program to be established in the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Record of Decision (ROD) for the Bear Creek Valley (BCV) Watershed, (2) revise several of the current technical requirements for groundwater monitoring based on implementation of the RCRA post-closure corrective action monitoring program during 1996, and (3) update applicable technical procedures with revised versions recently issued by the Y-12 Plant Groundwater Protection Program (GWPP). With these modifications, the Y-12 Plant will continue to meet the full intent of all regulatory obligations for post-closure care of these facilities. Section 2.0 provides the technical justification for each proposed permit modification. The proposed changes to permit language are provided in Section 3.0 (S-3 Ponds), Section 4.0 (Oil Landfarm), and Section 5.0 (Bear Creek Burial Grounds). Sections 6.0 and 7.0 reference updated and revised procedures for groundwater sampling, and monitoring well plugging and abandonment, respectively. Appendix A includes all proposed revisions to the PCP Attachments.

  10. 75 FR 18142 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Control of Air Pollution...

    Science.gov (United States)

    2010-04-09

    ...The EPA is proposing to approve revisions to the Texas State Implementation Plan (SIP) that amend Title 30 of the Texas Administrative Code (TAC), Chapter 114, Control of Air Pollution from Motor Vehicles. The State submitted these revisions on May 15, 2006, October 10, 2006, January 17, 2008, and February 28, 2008. These revisions establish the Rebate Grant Process and the Texas Clean School Bus Program under the Texas Emissions Reduction Plan (TERP), further amend the TERP, and amend the Locally Enforced Motor Vehicle Idling Limitations. The EPA is proposing to approve these SIP revisions because they allow for clarity and consistency of the SIP requirements. The EPA is proposing to approve these revisions pursuant to section 110 of the Federal Clean Air Act (CAA).

  11. Lymphocyte-Sparing Effect of Stereotactic Body Radiation Therapy in Patients With Unresectable Pancreatic Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Wild, Aaron T. [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Herman, Joseph M.; Dholakia, Avani S.; Moningi, Shalini [Department of Radiation Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Lu, Yao [Department of Oncology Biostatistics, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Rosati, Lauren M.; Hacker-Prietz, Amy; Assadi, Ryan K.; Saeed, Ali M. [Department of Radiation Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Pawlik, Timothy M. [Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Jaffee, Elizabeth M.; Laheru, Daniel A. [Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Tran, Phuoc T. [Department of Radiation Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Weiss, Matthew J.; Wolfgang, Christopher L. [Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Ford, Eric [Department of Radiation Oncology, University of Washington School of Medicine, Seattle, Washington (United States); Grossman, Stuart A. [Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Ye, Xiaobu [Department of Oncology Biostatistics, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Ellsworth, Susannah G., E-mail: sbatkoy2@jhmi.edu [Department of Radiation Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States)

    2016-03-01

    Purpose: Radiation-induced lymphopenia (RIL) is associated with inferior survival in patients with glioblastoma, lung cancer, and pancreatic cancer. We asked whether stereotactic body radiation therapy (SBRT) decreases severity of RIL compared to conventional chemoradiation therapy (CRT) in locally advanced pancreatic cancer (LAPC). Methods and Materials: Serial total lymphocyte counts (TLCs) from patients enrolled in a prospective trial of SBRT for LAPC were compared to TLCs from an existing database of LAPC patients undergoing definitive CRT. SBRT patients received 33 Gy (6.6 Gy × 5 fractions). CRT patients received a median dose of 50.4 Gy (1.8 Gy × 28 fractions) with concurrent 5-fluorouracil (77%) or gemcitabine (23%) therapy. Univariate and multivariate analyses (MVA) were used to identify associations between clinical factors and post-treatment TLC and between TLC and survival. Results: Thirty-two patients received SBRT and 101 received CRT. Median planning target volume (PTV) was smaller in SBRT (88.7 cm{sup 3}) than in CRT (344.6 cm{sup 3}; P<.001); median tumor diameter was larger for SBRT (4.6 cm) than for CRT (3.6 cm; P=.01). SBRT and CRT groups had similar median baseline TLCs. One month after starting radiation, 71.7% of CRT patients had severe lymphopenia (ie, TLC <500 cells/mm{sup 3} vs 13.8% of SBRT patients; P<.001). At 2 months, 46.0% of CRT patients remained severely lymphopenic compared with 13.6% of SBRT patients (P=.007). MVA demonstrated that treatment technique and baseline TLCs were significantly associated with post-treatment TLC at 1 but not 2 months after treatment. Higher post-treatment TLC was associated with improved survival regardless of treatment technique (hazard ratio [HR] for death: 2.059; 95% confidence interval: 1.310-3.237; P=.002). Conclusions: SBRT is associated with significantly less severe RIL than CRT at 1 month in LAPC, suggesting that radiation technique affects RIL and supporting previous modeling

  12. 76 FR 64368 - Notice of Submission of Proposed Information Collection to OMB Homelessness Prevention Study

    Science.gov (United States)

    2011-10-18

    ... Proposed Information Collection to OMB Homelessness Prevention Study AGENCY: Office of Policy Development... Homelessness Prevention Study. The proposed information collection was approved under emergency review (OMB...) has submitted to OMB a request to extend approval for information collection for the Homelessness...

  13. Predicting pathologic tumor response to chemoradiotherapy with histogram distances characterizing longitudinal changes in 18F-FDG uptake patterns

    Science.gov (United States)

    Tan, Shan; Zhang, Hao; Zhang, Yongxue; Chen, Wengen; D’Souza, Warren D.; Lu, Wei

    2013-01-01

    Purpose: A family of fluorine-18 (18F)-fluorodeoxyglucose (18F-FDG) positron-emission tomography (PET) features based on histogram distances is proposed for predicting pathologic tumor response to neoadjuvant chemoradiotherapy (CRT). These features describe the longitudinal change of FDG uptake distribution within a tumor. Methods: Twenty patients with esophageal cancer treated with CRT plus surgery were included in this study. All patients underwent PET/CT scans before (pre-) and after (post-) CRT. The two scans were first rigidly registered, and the original tumor sites were then manually delineated on the pre-PET/CT by an experienced nuclear medicine physician. Two histograms representing the FDG uptake distribution were extracted from the pre- and the registered post-PET images, respectively, both within the delineated tumor. Distances between the two histograms quantify longitudinal changes in FDG uptake distribution resulting from CRT, and thus are potential predictors of tumor response. A total of 19 histogram distances were examined and compared to both traditional PET response measures and Haralick texture features. Receiver operating characteristic analyses and Mann-Whitney U test were performed to assess their predictive ability. Results: Among all tested histogram distances, seven bin-to-bin and seven crossbin distances outperformed traditional PET response measures using maximum standardized uptake value (AUC = 0.70) or total lesion glycolysis (AUC = 0.80). The seven bin-to-bin distances were: L2 distance (AUC = 0.84), χ2 distance (AUC = 0.83), intersection distance (AUC = 0.82), cosine distance (AUC = 0.83), squared Euclidean distance (AUC = 0.83), L1 distance (AUC = 0.82), and Jeffrey distance (AUC = 0.82). The seven crossbin distances were: quadratic-chi distance (AUC = 0.89), earth mover distance (AUC = 0.86), fast earth mover distance (AUC = 0.86), diffusion distance (AUC = 0.88), Kolmogorov-Smirnov distance (AUC = 0.88), quadratic form distance

  14. Life cycle assessment of TV sets in China: a case study of the impacts of CRT monitors.

    Science.gov (United States)

    Song, Qingbin; Wang, Zhishi; Li, Jinhui; Zeng, Xianlai

    2012-10-01

    Along with the rapid increase in both production and use of TV sets in China, there is an increasing awareness of the environmental impacts related to the accelerating mass production, electricity use, and waste management of these sets. This paper aims to describe the application of life cycle assessment (LCA) to investigate the environmental performance of Chinese TV sets. An assessment of the TV set device (focusing on the Cathode Ray Tube (CRT) monitor) was carried out using a detailed modular LCA based on the international standards of the ISO 14040 series. The LCA was constructed using SimaPro software version 7.2 and expressed with the Eco-indicator' 99 life cycle impact assessment method. For a sensitivity analysis of the overall LCA results, the CML method was used in order to estimate the influence of the choice of the assessment method on the results. Life cycle inventory information was compiled by Ecoinvent 2.2 databases, combined with literature and field investigations on the current Chinese situation. The established LCA study shows that the use stage of such devices has the highest environmental impact, followed by the manufacturing stage. In the manufacturing stage, the CRT and the Printed Circuit Board (PCB) are those components contributing the most environmental impacts. During the use phase, the environmental impacts are due entirely to the methods of electricity generation used to run them, since no other aspects were taken into account for this phase. The final processing step-the end-of-life stage-can lead to a clear environmental benefit when the TV sets are processed through the formal dismantling enterprises in China. Copyright © 2012 Elsevier Ltd. All rights reserved.

  15. Life cycle assessment of TV sets in China: A case study of the impacts of CRT monitors

    International Nuclear Information System (INIS)

    Song Qingbin; Wang Zhishi; Li Jinhui; Zeng Xianlai

    2012-01-01

    Along with the rapid increase in both production and use of TV sets in China, there is an increasing awareness of the environmental impacts related to the accelerating mass production, electricity use, and waste management of these sets. This paper aims to describe the application of life cycle assessment (LCA) to investigate the environmental performance of Chinese TV sets. An assessment of the TV set device (focusing on the Cathode Ray Tube (CRT) monitor) was carried out using a detailed modular LCA based on the international standards of the ISO 14040 series. The LCA was constructed using SimaPro software version 7.2 and expressed with the Eco-indicator’ 99 life cycle impact assessment method. For a sensitivity analysis of the overall LCA results, the CML method was used in order to estimate the influence of the choice of the assessment method on the results. Life cycle inventory information was compiled by Ecoinvent 2.2 databases, combined with literature and field investigations on the current Chinese situation. The established LCA study shows that the use stage of such devices has the highest environmental impact, followed by the manufacturing stage. In the manufacturing stage, the CRT and the Printed Circuit Board (PCB) are those components contributing the most environmental impacts. During the use phase, the environmental impacts are due entirely to the methods of electricity generation used to run them, since no other aspects were taken into account for this phase. The final processing step—the end-of-life stage—can lead to a clear environmental benefit when the TV sets are processed through the formal dismantling enterprises in China.

  16. 75 FR 53727 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Approving Proposed Rule Change, as...

    Science.gov (United States)

    2010-09-01

    ... underwritings; (ii) supervision of market making commitments; (iii) final approval of advertisements as these... designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable...

  17. 77 FR 53210 - Notice of Proposed Information Collection: Comment Request; Request for Approval of Advance of...

    Science.gov (United States)

    2012-08-31

    ... cost not paid at final endorsement, non-critical repairs and capital needs assessment. The mortgagor... Credit Examiner, Inspector, and Architect, must use information collected to approve the withdrawal of...

  18. 40 CFR 265.118 - Post-closure plan; amendment of plan.

    Science.gov (United States)

    2010-07-01

    ... mail. In addition, for facilities without approved post-closure plans, it must also be provided during... requirements. At the end of the specified period of suspension, the Regional Ad-min-is-tra-tor would then...

  19. Representation of nuclear reactor information by means of colour CRT display - a contribution to man-machine communication

    International Nuclear Information System (INIS)

    Stein, H.

    1984-01-01

    A data representing technique of special nuclear reactor measurement values by means of colour CRT display is discribed. The data of an incore measurement system are logged continously. A primary data processing is followed by a calculation of selected incore parameters. The parameters are offered the operator on a colour display completed by other important values of the conventional reactor instrumentation. The method is realized by the microprocessor system ursadat 5000, robotron 1600, and MPS 4944. The bit-serial data transmission requires a line interface working in a multipoint regime. The software consists of modules to allow the insertion in a superordinate automation system. (author)

  20. Virtual-based training and critical thinking in higher-level education

    Directory of Open Access Journals (Sweden)

    Kalayanee Jitgarun

    2009-06-01

    Full Text Available The purpose of the study was to determine if Virtual-Based Training (VBT could be used to develop post-secondarystudents’ abilities in critical thinking (CRT. The participants were 26 second-year undergraduate students from fourfaculties at a government-funded university in Bangkok, Thailand and were divided into 2 groups. The experimental groupstudied 23 CRT lessons through VBT and had to hand in their exercises. There was no treatment for the control group. Thepre- and post- tests were analyzed using multiple correlations. Results revealed that there was a relationship of the preandpost- tests of language and mathematics with CRT. This means that our VBT was effective for teaching language andmathematics. Further studies will be to determine if it was the content (the type of CRT lessons or the delivery mode (VBTthat resulted in no significant difference in test scores for logical reasoning

  1. Lead extraction from Cathode Ray Tube (CRT) funnel glass: Reaction mechanisms in thermal reduction with addition of carbon (C).

    Science.gov (United States)

    Lu, Xingwen; Ning, Xun-An; Chen, Da; Chuang, Kui-Hao; Shih, Kaimin; Wang, Fei

    2018-06-01

    This study quantitatively determined the extraction of lead from CRT funnel glass and examined the mechanisms of thermally reducing lead in the products of sintering Pb-glass with carbon in the pre-heated furnace. The experimentally derived results indicate that a 90.3 wt% lead extraction efficiency can be achieved with 20 wt% of C addition at 950 °C for 3 min under air. The formation of viscous semi-liquid glass blocked the oxygen supply between the interaction of C and Pb-glass, and was highly effective for the extraction of metallic Pb. A maximum of 87.3% lead recover was obtained with a C to Na 2 CO 3 ratio of 1/3 at 1200 °C. The decrease of C/Na 2 CO 3 ratio enhanced the metallic lead recovery by increasing the glass viscosity for effective sedimentation of metallic lead in the bottom. However, with the further increase of temperature and treatment time, re-vitrification of lead back to silicate-glass matrix was detected in both Pb-glass/C and Pb-glass/C/Na 2 CO 3 systems. The findings indicated that with proper controls, using C as an inexpensive reagent can effectively reduce treatment time and energy, which is crucial to a waste-to-resource technology for economically recovering lead from the waste CRT glass. Copyright © 2018 Elsevier Ltd. All rights reserved.

  2. A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.

    Science.gov (United States)

    Coppens, D G M; de Wilde, S; Guchelaar, H J; De Bruin, M L; Leufkens, H G M; Meij, P; Hoekman, J

    2018-05-02

    There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  3. Reduced left ventricular mechanical dispersion in heart failure patients undergoing cardiac resynchronisation therapy is associated with superior long-term outcome.

    Science.gov (United States)

    van der Bijl, Pieter; Khidir, Mand Jh; Leung, Melissa; Yilmaz, Dilek; Mertens, Bart; Marsan, Nina Ajmone; Delgado, Victoria; Bax, Jeroen J

    2018-05-09

    In heart failure (HF) patients, left ventricular mechanical dispersion (LVMD) reflects heterogeneous mechanical activation of the left ventricle. In HF patients, LVMD can be reduced after CRT. Whether lesser LVMD is associated with improved outcome is unknown. To relate LVMD to long-term prognosis in a large cohort of HF patients after 6 months of cardiac resynchronization therapy (CRT). Clinical, echocardiographic and ventricular arrhythmia (VA) data were analyzed from an ongoing registry of HF recipients of CRT. Baseline (prior to CRT) and 6-month echocardiograms were evaluated. LVMD was calculated as the standard deviation of the time from onset of the QRS complex to the peak longitudinal strain in a 17-segment model. Patients were divided into two groups, according to the median LVMD (84 ms) at 6 months post-CRT. Of 1,185 patients (mean age 65±10 years, 76% male), 343 (29%) died during a mean follow-up of 55±36 months. Baseline LVMD was not associated with all-cause mortality and VA at follow-up. In contrast, patients with less LVMD (≤84 ms) at 6 months post-CRT had lower event rates (VA and mortality) compared to those with LVMD >84 ms. On multivariable analysis, greater LVMD at 6 months after CRT was independently associated with an increased risk of mortality (hazard ratio, 1.002; P=0.037) and VA (hazard ratio, 1.003; P=0.026) . Larger LVMD at 6 months after CRT is independently associated with all-cause mortality and VA. LVMD may be valuable in identifying patients who remain at high mortality risk after CRT implantation. Copyright © 2018. Published by Elsevier Inc.

  4. Diagnostic accuracy and prognostic impact of restaging by magnetic resonance imaging after preoperative chemoradiotherapy in patients with rectal cancer

    International Nuclear Information System (INIS)

    Huh, Jung Wook; Kim, Hee Cheol; Lee, Soon Jin; Yun, Seong Hyeon; Lee, Woo Yong; Park, Yoon Ah; Cho, Yong Beom; Chun, Ho-Kyung

    2014-01-01

    Background: The prognostic role of restaging rectal magnetic resonance imaging (MRI) in patients with preoperative CRT has not been established. The goal of this study was to evaluate the diagnostic accuracy and prognostic role of radiological staging by rectal MRI after preoperative chemoradiation (CRT) in patients with rectal cancer. Methods: A total of 231 consecutive patients with rectal cancer who underwent preoperative CRT and radical resection from January 2008 to December 2009 were prospectively enrolled. The diagnostic accuracy and prognostic significance of post-CRT radiological staging by MRI was evaluated. Results: The sensitivity, specificity, positive predictive value, and negative predictive value of radiological diagnosis of good responders (ypTNM stage 0–I) were 32%, 90%, 65%, and 69%, respectively. The overall accuracy of MRI restating for good responders was 68%. The 5-year disease-free survival rates of patients with radiological and pathological TNM stage 0, stage I, and stage II–III were 100%, 94%, and 76%, respectively (P = 0.037), and 97%, 87%, and 73%, respectively (P = 0.007). On multivariate analysis, post-CRT radiological staging by MRI was an independent prognostic factor for disease-free survival. Conclusion: Radiological staging by MRI after preoperative CRT may be an independent predictor of survival in patients with rectal cancer

  5. 76 FR 60774 - Review and Approval of Projects

    Science.gov (United States)

    2011-09-30

    ... SUSQUEHANNA RIVER BASIN COMMISSION 18 CFR Part 806 Review and Approval of Projects AGENCY: Susquehanna River Basin Commission. ACTION: Notice of proposed rulemaking; reopening of comment period. SUMMARY: The purpose of this document is to inform the public of an extension of the comment period for...

  6. Exercise ameliorates neurocognitive impairments in a translational model of pediatric radiotherapy.

    Science.gov (United States)

    Sahnoune, Iman; Inoue, Taeko; Kesler, Shelli R; Rodgers, Shaefali P; Sabek, Omaima M; Pedersen, Steen E; Zawaski, Janice A; Nelson, Katharine H; Ris, M Douglas; Leasure, J Leigh; Gaber, M Waleed

    2018-04-09

    While cranial radiation therapy (CRT) is an effective treatment, healthy areas surrounding irradiation sites are negatively affected. Frontal lobe functions involving attention, processing speed, and inhibition control are impaired. These deficits appear months to years after CRT and impair quality of life. Exercise has been shown to rejuvenate the brain and aid in recovery post-injury through its effects on neurogenesis and cognition. We developed a juvenile rodent CRT model that reproduces neurocognitive deficits. Next, we utilized the model to test whether exercise ameliorates these deficits. Fischer rats (31 days old) were irradiated with a fractionated dose of 4 Gy × 5 days, trained and tested at 6, 9, and 12 months post-CRT using 5-choice serial reaction time task. After testing, fixed rat brains were imaged using diffusion tensor imaging and immunohistochemistry. CRT caused early and lasting impairments in task acquisition, accuracy, and latency to correct response, as well as causing stunting of growth and changes in brain volume and diffusion. Exercising after irradiation improved acquisition, behavioral control, and processing speed, mitigated the stunting of brain size, and increased brain fiber numbers compared with sedentary CRT values. Further, exercise partially restored global connectome organization, including assortativity and characteristic path length, and while it did not improve the specific regional connections that were lowered by CRT, it appeared to remodel these connections by increasing connectivity between alternate regional pairs. Our data strongly suggest that exercise may be useful in combination with interventions aimed at improving cognitive outcome following pediatric CRT.

  7. Comparison between CT volume measurement and histopathological assessment of response to neoadjuvant therapy in rectal cancer

    Energy Technology Data Exchange (ETDEWEB)

    Pomerri, Fabio, E-mail: fabio.pomerri@unipd.it [Veneto Institute of Oncology IOV-IRCCS, via Gattamelata 64, 35128 Padua (Italy); Department of Medicine, University of Padua, via Giustiniani 2, 35128 Padua (Italy); Pucciarelli, Salvatore, E-mail: puc@unipd.it [Department of Oncological and Surgical Sciences, University of Padua, via Giustiniani 2, 35128 Padua (Italy); Gennaro, Gisella, E-mail: gisella.gennaro@pd.infn.it [Veneto Institute of Oncology IOV-IRCCS, via Gattamelata 64, 35128 Padua (Italy); Maretto, Isacco, E-mail: isac77@gmail.com [Veneto Institute of Oncology IOV-IRCCS, via Gattamelata 64, 35128 Padua (Italy); Nitti, Donato, E-mail: donato.nitti@unipd.it [Department of Oncological and Surgical Sciences, University of Padua, via Giustiniani 2, 35128 Padua (Italy); Muzzio, Pier Carlo, E-mail: pcmuzzio@unipd.it [Veneto Institute of Oncology IOV-IRCCS, via Gattamelata 64, 35128 Padua (Italy)

    2012-12-15

    Objectives: The aim of this study was to compare volume measurements on computed tomography (CT) images with histopathological assessments of chemoradiotherapy (CRT)-induced tumor regression in locally advanced rectal cancer (RC). Methods: In 25 patients (13 males, 12 females; median age, 63 years; age range, 44–79 years) with locally advanced RC treated with preoperative CRT and surgery, two radiologists measured tumor volume on CT images before and after CRT. CT-based tumor volumetry and the modified response evaluation criteria in solid tumors (mRECISTs) were compared with T and N downstaging after CRT, and with the tumor regression grade (TRG). Results: Tumor volumes were significantly smaller on CT images after CRT. The tumors regressed in 52% (13/25), 36% (9/25) and 40% (10/25) of patients, based on T downstaging, TRG and mRECIST findings, respectively. In terms of T downstaging, the pre- and post-CRT tumor volumes of responders and non-responders to the treatment differed statistically, while their tumor volume reduction rates and volume reductions according to the 65% mRECIST threshold did not. In terms of N downstaging and TRG, the differences between the responders’ and the non-responders’ pre- and post-CRT tumor volumes, tumor volume reduction rates, and mRECIST thresholds were never statistically significant. Conclusion: Measuring tumor size on CT images is of limited value in predicting the histopathological response to preoperative CRT in RC patients, so it may be unwise to select surgical treatment strategies based on CT volumetry.

  8. Prone Hypofractionated Whole-Breast Radiotherapy Without a Boost to the Tumor Bed: Comparable Toxicity of IMRT Versus a 3D Conformal Technique

    Energy Technology Data Exchange (ETDEWEB)

    Hardee, Matthew E.; Raza, Shahzad; Becker, Stewart J.; Jozsef, Gabor; Lymberis, Stella C. [Department of Radiation Oncology, New York University School of Medicine, New York, NY (United States); Hochman, Tsivia; Goldberg, Judith D. [Division of Biostatistics, New York University School of Medicine, New York, NY (United States); DeWyngaert, Keith J. [Department of Radiation Oncology, New York University School of Medicine, New York, NY (United States); Formenti, Silvia C., E-mail: silvia.formenti@nyumc.org [Department of Radiation Oncology, New York University School of Medicine, New York, NY (United States)

    2012-03-01

    Purpose: We report a comparison of the dosimetry and toxicity of three-dimensional conformal radiotherapy (3D-CRT) vs. intensity-modulated radiotherapy (IMRT) among patients treated in the prone position with the same fractionation and target of the hypofractionation arm of the Canadian/Whelan trial. Methods and Materials: An institutional review board-approved protocol identified a consecutive series of early-stage breast cancer patients treated according to the Canadian hypofractionation regimen but in the prone position. Patients underwent IMRT treatment planning and treatment if the insurance carrier approved reimbursement for IMRT; in case of refusal, a 3D-CRT plan was used. A comparison of the dosimetric and toxicity outcomes during the acute, subacute, and long-term follow-up of the two treatment groups is reported. Results: We included 97 consecutive patients with 100 treatment plans in this study (3 patients with bilateral breast cancer); 40 patients were treated with 3D-CRT and 57 with IMRT. IMRT significantly reduced the maximum dose (Dmax median, 109.96% for 3D-CRT vs. 107.28% for IMRT; p < 0.0001, Wilcoxon test) and improved median dose homogeneity (median, 1.15 for 3D-CRT vs. 1.05 for IMRT; p < 0.0001, Wilcoxon test) when compared with 3D-CRT. Acute toxicity consisted primarily of Grade 1 to 2 dermatitis and occurred in 92% of patients. Grade 2 dermatitis occurred in 13% of patients in the 3D-CRT group and 2% in the IMRT group. IMRT moderately decreased rates of acute pruritus (p = 0.03, chi-square test) and Grade 2 to 3 subacute hyperpigmentation (p = 0.01, Fisher exact test). With a minimum of 6 months' follow-up, the treatment was similarly well tolerated in either group, including among women with large breast volumes. Conclusion: Hypofractionated breast radiotherapy is well tolerated when treating patients in the prone position, even among those with large breast volumes. Breast IMRT significantly improves dosimetry but yields only a modest

  9. Template for letter of approval by Research Supervisor

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

    Liliane Castets-Poupart

    a) As research supervisor of J. Smith, I confirm that I approve and support the research proposal submitted by the candidate. b) J. Smith has successfully completed the following course(s):. STAT 890: Statistics, Survey Design and Analysis INAF 540: International Affairs Dynamics. ECON 700: Qualitative Research Data.

  10. Salvage esophagectomy post definitive chemoradiotherapy or radiotherapy

    International Nuclear Information System (INIS)

    Hosokawa, Masao; Suzuki, Yasuhiro; Nisida, Yasunori

    2008-01-01

    Outcome of salvage esophagectomy (SE), which was done due to rest development or recurrence after radical treatment of the esophageal cancer with radio- (RT) or chemoradio-therapy (CRT), was retrospectively studied and discussed. Subjects were 61 patients (M 54, F 7: average age, 63.5 y) with the cancer at Stage I- early IVB who had undergone radical CRT (35 cases) and RT (26) with >50 Gy, had no lymphatic and remote metastases at the diagnosis of the recurrence and then received SE and reconstruction surgery. Rough 5-year survival was found to be 29.2% in CRT group and 32.3% in RT. Operation-related death was 1 case (sepsis) and the rate of complication was slightly higher than the ordinary SE. Based on above outcome, discussion was made on following tasks and/or measures in authors' hospital: diagnostic means like the combination with positron emission tomography (PET), dose/regions of irradiation (dose to the heart and lung should be < TD 5/5=tolerance dose to be <5% incidence of adverse effect within 5 years) and of chemotherapy, decision of the irradiation area with consideration of SE afterward, careful surgery to reduce complication, and sufficient preoperative evaluation for radical surgery by images like PET/CT. Operation with consideration of these items conceivably makes SE safer. (R.T.)

  11. 76 FR 38231 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Order Approving Proposed Rule...

    Science.gov (United States)

    2011-06-29

    ... No. 1, To Reduce the Minimum Size of the Nominating and Governance Committee June 22, 2011. I... size of the Nominating and Governance Committee (``NGC'') from seven to five. On May 18, 2011, the..., it had not yet obtained formal approval from its Board of Directors for the specific Bylaw changes...

  12. Auditing the process of ethics approval for Master’s degrees at a South African university

    Directory of Open Access Journals (Sweden)

    Damian Clarke

    2014-04-01

    Full Text Available Introduction. This study audited the process of ethics approval for Master’s research at the Nelson R Mandela School of Medicine, Durban, KwaZulu-Natal, South Africa.Methods. After obtaining the appropriate ethical approval, all the correspondence surrounding each Master’s proposal for the year 2010 was reviewed. Results. A total of 53 proposals for Master’s degrees were available for review. All the proposals were for low-risk studies, and all were subjected to expedited review. It took an average of 15 weeks (range 3 - 32 for the institutional ethics review board (the Biomedical Research Ethics Committee (BREC to respond to each of the 53 proposals. Twenty-three studies (43.4% received provisional approval on the first response, 2 proposals (3.8% were rejected, and 28 proposals (52.8% were sent back with major queries. For the 28 proposals that required major revisions, 11 responses had been submitted by the time the data were collected. The average length of time to receive a response from the applicants to BREC queries was 4 weeks.Conclusion. This study suggests that there is a potential cumulative delay of over 4 months before data collection for low-risk clinical audits can be commenced. Any system designed to improve this situation must ensure that high standards of vigilance are maintained, but must be flexible enough to allow for a faster review and approval process.

  13. Effectiveness of Animal Assisted Therapy after brain injury: A bridge to improved outcomes in CRT.

    Science.gov (United States)

    Stapleton, Mary

    2016-06-18

    Animal Assisted Therapy (AAT) has been widely used as a complementary therapy in mental health treatment especially to remediate social skill deficits. The goal of AAT is to improve social, emotional, and cognitive functioning. The purpose of this article is to draw upon the literature on AAT and explore specific applications to cognitive rehabilitation therapy (CRT) and social skills training. This study provides a systematic review of most of the available literature on ATT and assesses that potential uses of ATT for brain injury rehabilitation. Although the efficacy of AAT is not currently well documented by rigorous research, (Kazin, 2010) anecdotal evidence suggests that brain injury survivors may benefit from the combination of AAT and cognitive rehabilitation techniques. Acquired Brain Injury (ABI) survivors with cognitive impairments can benefit from AAT as part of a comprehensive and holistic rehabilitation treatment plan.

  14. 77 FR 3144 - Approval and Promulgation of Air Quality Implementation Plans; Missouri; Reasonably Available...

    Science.gov (United States)

    2012-01-23

    ... comments on this proposal. Therefore, based on the rational stated in the proposal, EPA is approving this..., petitions for judicial review of this action must be filed in the United States Court of Appeals for the...

  15. 76 FR 1619 - Proposed Information Collection Activity; Comment Request

    Science.gov (United States)

    2011-01-11

    ... SACWIS Assessment Reviews, at any time in the system life cycle. Submission of the SACWIS SARG and other...-0159] Proposed Information Collection Activity; Comment Request Proposed Projects Title: Statewide... the project, as described in the approved Advance Planning Document, have been adequately completed...

  16. Military service and military vocational training effects on post-service earnings

    OpenAIRE

    Bolin, Phil Warren

    1980-01-01

    Approved for public release; distribution is unlimited. The influence of military service and military vocational training on post-service earnings was analyzed using the National Longitudinal Survey of young men (14-24 years of age in 1966) . When individuals were classified by their propensity to use training neither military service nor military vocational training was a significant determinant of post-service earnings. A disaggregation of the sample IQ revealed that m...

  17. 78 FR 45112 - Approval and Promulgation of Air Quality Implementation Plans; Missouri; Reasonably Available...

    Science.gov (United States)

    2013-07-26

    ... description of the VOC rule that is proposed for approval in this action is provided below. 10 CSR 10-5.455... to approve a revision to Missouri's VOC rule 10 CSR 10-5.455 into Missouri's SIP, as EPA believes... regulatory action'' subject to review by the Office of Management and Budget under Executive Order 12866 (58...

  18. Curriculum Online Review System: Proposing Curriculum with Collaboration

    Science.gov (United States)

    Rhinehart, Marilyn; Barlow, Rhonda; Shafer, Stu; Hassur, Debby

    2009-01-01

    The Curriculum Online Review System (CORS) at Johnson County Community College (JCCC) uses SharePoint as a Web platform for the JCCC Curriculum Proposals Process. The CORS application manages proposals throughout the approval process using collaboration tools and workflows to notify all stakeholders. This innovative new program has changed the way…

  19. Radiation dose ≥54 Gy and CA 19–9 response are associated with improved survival for unresectable, non-metastatic pancreatic cancer treated with chemoradiation

    Directory of Open Access Journals (Sweden)

    Golden Daniel W

    2012-09-01

    Full Text Available Abstract Background Unresectable pancreatic cancer (UPC has low survival. With improving staging techniques and systemic therapy, local control in patients without metastatic disease may have increasing importance. We investigated whether the radiation dose used in chemoradiation (CRT as definitive treatment for UPC and the CA 19–9 response to therapy have an impact on overall survival (OS. Methods From 1997–2009 46 patients were treated with CRT for non-metastatic UPC. Median prescribed RT dose was 54 Gy (range 50.4-59.4 Gy. All patients received concurrent chemotherapy (41: 5-fluorouracil, 5: other and 24 received adjuvant chemotherapy. Results 41 patients were inoperable due to T4 disease and 5 patients with T3 disease were medically inoperable. Five patients did not complete CRT due to progressive disease or treatment-related toxicity (median RT dose 43.2 Gy. Overall, 42 patients were dead of disease at the time of last follow-up. The median and 12 month OS were 8.8 months and 35%, respectively. By univariate analysis, minimum CA 19–9 post-CRT Conclusions CRT as definitive treatment for UPC had low survival. However, our retrospective data suggest that patients treated to ≥54 Gy or observed to have a minimum post-CRT CA 19–9

  20. Proposed modifications to the RCRA post-closure permit for the Chestnut Ridge Hydrogeologic Regime at the U.S. Department of Energy Y-12 Plant, Oak Ridge, Tennessee

    International Nuclear Information System (INIS)

    1997-05-01

    This report presents proposed modifications to several conditions of the Resource Conservation and Recovery Act (RCRA) Post-Closure Permit (PCP) for the Chestnut Ridge Hydrogeologic Regime (CRHR) (permit number TNHW-088, EPA ID No. TN3 89 009 0001). These permit conditions define the requirements for RCRA post-closure detection groundwater monitoring at the Chestnut Ridge Sediment Disposal Basin (CRSDB) and Kerr Hollow Quarry (KHQ), and RCRA post-closure corrective action groundwater monitoring at the Chestnut Ridge Security Pits (CRSPs). Modification of these PCP conditions is requested to: (1) clarify the planned integration of RCRA post-closure corrective action groundwater monitoring at the CRSPs with the monitoring program to be established in the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) record of decision (ROD), (2) revise several of the current technical requirements for groundwater monitoring based on implementation of the RCRA monitoring programs during 1996, (3) replace several of the technical procedures included in the PCP with updated versions recently issued by the Y-12 Plant Groundwater Protection Program (GWPP), and (4) correct inaccurate regulatory citations and references to permit conditions and permit attachments. With these modifications, the Y- 12 Plant will continue to meet the full intent of all regulatory obligations for post-closure care of these facilities. Section 2 provides the technical justification for each proposed permit modification. Section 3.0 contains proposed changes to Section II of the PCP. Modifications to site-specific permit conditions are presented in Section 4.0 (CRSDB), Section 5.0 (CRSPs), and Section 6.0 (KHQ). Sections 7.0 and 8.0 reference updated and revised procedures for groundwater sampling, and monitoring well plugging and abandonment, respectively. Appendix A includes all proposed revisions to the permit attachments

  1. Proposed modifications to the RCRA post-closure permit for the Chestnut Ridge Hydrogeologic Regime at the U.S. Department of Energy Y-12 Plant, Oak Ridge, Tennessee

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-05-01

    This report presents proposed modifications to several conditions of the Resource Conservation and Recovery Act (RCRA) Post-Closure Permit (PCP) for the Chestnut Ridge Hydrogeologic Regime (CRHR) (permit number TNHW-088, EPA ID No. TN3 89 009 0001). These permit conditions define the requirements for RCRA post-closure detection groundwater monitoring at the Chestnut Ridge Sediment Disposal Basin (CRSDB) and Kerr Hollow Quarry (KHQ), and RCRA post-closure corrective action groundwater monitoring at the Chestnut Ridge Security Pits (CRSPs). Modification of these PCP conditions is requested to: (1) clarify the planned integration of RCRA post-closure corrective action groundwater monitoring at the CRSPs with the monitoring program to be established in the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) record of decision (ROD), (2) revise several of the current technical requirements for groundwater monitoring based on implementation of the RCRA monitoring programs during 1996, (3) replace several of the technical procedures included in the PCP with updated versions recently issued by the Y-12 Plant Groundwater Protection Program (GWPP), and (4) correct inaccurate regulatory citations and references to permit conditions and permit attachments. With these modifications, the Y- 12 Plant will continue to meet the full intent of all regulatory obligations for post-closure care of these facilities. Section 2 provides the technical justification for each proposed permit modification. Section 3.0 contains proposed changes to Section II of the PCP. Modifications to site-specific permit conditions are presented in Section 4.0 (CRSDB), Section 5.0 (CRSPs), and Section 6.0 (KHQ). Sections 7.0 and 8.0 reference updated and revised procedures for groundwater sampling, and monitoring well plugging and abandonment, respectively. Appendix A includes all proposed revisions to the permit attachments.

  2. 76 FR 68699 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adoption of the...

    Science.gov (United States)

    2011-11-07

    ... formed in the atmosphere as a result of various chemical reactions from precursor emissions of nitrogen... is proposing to conditionally approve the air quality modeling submitted to demonstrate attainment of the 1997 PM 2.5 NAAQS. In order for EPA to fully approve the modeling analysis, PADEP must update the...

  3. 78 FR 26301 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Consumer Products and...

    Science.gov (United States)

    2013-05-06

    ... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2010-0394; EPA-R05-OAR-2012-0786; FRL-9786-1] Approval and Promulgation of Air Quality Implementation Plans; Illinois; Consumer Products and... consumer products categories into the State's SIP. Finally, EPA is proposing to approve language to clarify...

  4. Teaching Post-Pornography

    Directory of Open Access Journals (Sweden)

    Tim Gregory

    2018-04-01

    Full Text Available This article introduces the term ‘post-pornography’, drawing on diverse texts from the last three decades. We propose that ‘post-pornography’ expands Porn Studies beyond its focus on explicit representations of sex. First, we outline the history of post-pornography as a concept that emerged in the sex-positive, anti-censorship and queer/feminist moment in the United States in the 1980s and 1990s and has subsequently been taken up by a diverse group of artists, activists and scholars to describe practices that both reference and attempt to move beyond pornography. We define post-pornography as characterised by three aspects—the denaturalising of sex, the de-centring of the spectator and the recognition of media and technology as inseparable from sex. We examine the history of Porn Studies in the university, including in our own faculty at UNSW Art & Design, and the singular influence of Linda Williams in defining its place and setting out its pedagogical methods. We propose post-pornography as a framework that can confront prevailing assumptions about sex and sexuality that underpin Porn Studies and its critique of pornography, and outline a set of concepts that have emerged from the development of the second- and third-year art theory course Post-Pornographic Bodies.

  5. 77 FR 25003 - Self-Regulatory Organizations; NASDAQ OMX Phlx LLC; Order Approving Proposed Rule Change To Amend...

    Science.gov (United States)

    2012-04-26

    ...; review and endorsement of customer orders; final approval of advertising or sales literature for use by... and qualified, given the importance and complexity of the rules governing financial responsibility for...

  6. Template for letter of approval by Research Supervisor

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

    Liliane Castets-Poupart

    a) the approval of the candidate's final version of their research proposal (not just the research topic) by the research supervisor; b) the list of courses already completed and still to be completed by the candidate in the master's/PhD program; c) confirmation that all courses will be completed, and, for PhD candidates,.

  7. 76 FR 59600 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Redesignation of Lake and...

    Science.gov (United States)

    2011-09-27

    ...] Approval and Promulgation of Air Quality Implementation Plans; Indiana; Redesignation of Lake and Porter... redesignation of the Lake and Porter Counties, Indiana portion (Lake and Porter Counties) of the Chicago-Gary... or standard). EPA is proposing to approve the redesignation request for Lake and Porter Counties...

  8. Authority approvals and environmental investigations

    International Nuclear Information System (INIS)

    Olsen, F.A.; Svenson, J.

    1999-01-01

    The possible sites have been reviewed environmentally and approved in principle by the Danish authorities through 'The Offshore Wind Turbine Committee'. Therefore, environmental studies were not expected to form par of this study. However, the contacts to the authorities revealed a need for further investigations. A required Environmental Impact Study shall be performed in accordance with EC directive of June 27 1985 and March 3 1997, and more specific requirements from the Danish authorities. The possible visual impacts of the proposed large scale offshore project at Roedsand proved to be a major issue for the local acceptance of the projects. Therefore, computer aided visualisations of selected views of all 3 projects were performed and presented to the public. The visualisations were performed with dedicated computer programmes and are presented on colour photos seen from land, sea and air. As a conclusion, the possible visual impact of the proposed projects are not found to be prohibitive for a realisation of the proposed projects. (LN)

  9. 77 FR 59090 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adhesives and...

    Science.gov (United States)

    2012-09-26

    ... Promulgation of Air Quality Implementation Plans; Pennsylvania; Adhesives and Sealants Rule AGENCY... manufacture, sale, use, or application of adhesives, sealants, primers, and solvents. The SIP revision also... proposed rulemaking (NPR) which proposed approval of Pennsylvania's adhesives and sealants regulations in...

  10. 39 CFR 111.4 - Approval of the Director of the Federal Register.

    Science.gov (United States)

    2010-07-01

    ... 39 Postal Service 1 2010-07-01 2010-07-01 false Approval of the Director of the Federal Register. 111.4 Section 111.4 Postal Service UNITED STATES POSTAL SERVICE POST OFFICE SERVICES [DOMESTIC MAIL...) and 1 CFR part 51 on June 4, 2010. (5 U.S.C. 552(a); 39 U.S.C. 401, 404, 407, 408, 3001-3011, 3201...

  11. Design and analysis of post-marketing research.

    Science.gov (United States)

    Zhou, Xiao-Hua Andrew; Yang, Wei

    2013-07-01

    A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.

  12. 77 FR 23652 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Leisure Properties LLC/D...

    Science.gov (United States)

    2012-04-20

    ... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2011-0944; FRL-9648-7] Approval and Promulgation of Air Quality Implementation Plans; Illinois; Leisure Properties LLC/D/B/A Crownline Boats... proposing to approve into the Illinois State Implementation Plan (SIP) an adjusted standard for Leisure...

  13. 75 FR 80834 - Proposed Information Collection

    Science.gov (United States)

    2010-12-23

    .... Abstract: Respondents are all Secret Service applicants who, if approved for hire, will require a Top... Service to determine an applicant's eligibility for a Top Secret Clearance, and ensure that the applicant... DEPARTMENT OF HOMELAND SECURITY Secret Service Proposed Information Collection ACTION: 30-day...

  14. Photoaffinity Labeling of the Plasmodium falciparum Chloroquine Resistance Transporter with a Novel Perfluorophenylazido Chloroquine†

    Science.gov (United States)

    Lekostaj, Jacqueline K.; Natarajan, Jayakumar K.; Paguio, Michelle F.; Wolf, Christian; Roepe, Paul D.

    2009-01-01

    Several models describing how amino acid substitutions in the Plasmodium falciparum chloroquine resistance transporter (PfCRT) confer resistance to chloroquine (CQ) and other antimalarial drugs have been proposed. Further progress requires molecular analysis of interactions between purified reconstituted PfCRT protein and these drugs. We have thus designed and synthesized several perfluorophenyl azido (pfpa) CQ analogues for PfCRT photolabeling studies. One particularly useful probe (AzBCQ) places the pfpa group at the terminal aliphatic N of CQ via a flexible four-carbon ester linker and includes a convenient biotin tag. This probe photolabels PfCRT in situ with high specificity. Using reconstituted proteoliposomes harboring partially purified recombinant PfCRT, we analyze AzBCQ photolabeling versus competition with CQ and other drugs to probe the nature of the CQ binding site. We also inspect how pH, the chemoreversal agent verapamil (VPL), and various amino acid mutations in PfCRT that cause CQ resistance (CQR) affect the efficiency of AzBCQ photolabeling. Upon gel isolation of AzBCQ-labeled PfCRT followed by trypsin digestion and mass spectrometry analysis, we are able to define a single AzBCQ covalent attachment site lying within the digestive vacuolar-disposed loop between putative helices 9 and 10 of PfCRT. Taken together, the data provide important new insight into PfCRT function and, along with previous results, allow us to propose a model for a single CQ binding site in the PfCRT protein. PMID:18767816

  15. Photoaffinity labeling of the Plasmodium falciparum chloroquine resistance transporter with a novel perfluorophenylazido chloroquine.

    Science.gov (United States)

    Lekostaj, Jacqueline K; Natarajan, Jayakumar K; Paguio, Michelle F; Wolf, Christian; Roepe, Paul D

    2008-09-30

    Several models describing how amino acid substitutions in the Plasmodium falciparum chloroquine resistance transporter (PfCRT) confer resistance to chloroquine (CQ) and other antimalarial drugs have been proposed. Further progress requires molecular analysis of interactions between purified reconstituted PfCRT protein and these drugs. We have thus designed and synthesized several perfluorophenyl azido (pfpa) CQ analogues for PfCRT photolabeling studies. One particularly useful probe (AzBCQ) places the pfpa group at the terminal aliphatic N of CQ via a flexible four-carbon ester linker and includes a convenient biotin tag. This probe photolabels PfCRT in situ with high specificity. Using reconstituted proteoliposomes harboring partially purified recombinant PfCRT, we analyze AzBCQ photolabeling versus competition with CQ and other drugs to probe the nature of the CQ binding site. We also inspect how pH, the chemoreversal agent verapamil (VPL), and various amino acid mutations in PfCRT that cause CQ resistance (CQR) affect the efficiency of AzBCQ photolabeling. Upon gel isolation of AzBCQ-labeled PfCRT followed by trypsin digestion and mass spectrometry analysis, we are able to define a single AzBCQ covalent attachment site lying within the digestive vacuolar-disposed loop between putative helices 9 and 10 of PfCRT. Taken together, the data provide important new insight into PfCRT function and, along with previous results, allow us to propose a model for a single CQ binding site in the PfCRT protein.

  16. 38 CFR 17.65 - Approvals and provisional approvals of community residential care facilities.

    Science.gov (United States)

    2010-07-01

    ... approvals of community residential care facilities. 17.65 Section 17.65 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Community Residential Care § 17.65 Approvals and provisional approvals of community residential care facilities. (a) An approval of a facility meeting all of...

  17. Approval of radioactive consumer goods

    International Nuclear Information System (INIS)

    Paynter, R.A.

    1992-01-01

    The 1980 Euratom Directive obliges the UK to draw up a system of prior authorization for the use of radioactive substances in a range of consumer products, and the Government intends to make regulations to fulfil the requirements of the Directive. These regulations will empower NRPB to approve such products prior to their supply to the public. In this brief article, the NRPB reviews the criteria against which to consider any proposed use of radioactive substances, considers radiological production standards for products and discusses the questions of the labelling of radioactive consumer goods. (UK)

  18. A pilot study of pNGVL4a-CRT/E7(detox) for the treatment of patients with HPV16+ cervical intraepithelial neoplasia 2/3 (CIN2/3).

    Science.gov (United States)

    Alvarez, Ronald D; Huh, Warner K; Bae, Sejong; Lamb, Lawrence S; Conner, Michael G; Boyer, Jean; Wang, Chenguang; Hung, Chien-Fu; Sauter, Elizabeth; Paradis, Mihaela; Adams, Emily A; Hester, Shirley; Jackson, Bradford E; Wu, T C; Trimble, Cornelia L

    2016-02-01

    The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of a plasmid vaccine, pNGVL4a-CRT-E7(detox), administered either intradermally, intramuscularly, or directly into the cervical lesion, in patients with HPV16-associated CIN2/3. Eligible patients with HPV16(+) CIN2/3 were enrolled in treatment cohorts evaluating pNGVL4a-CRT-E7(detox), administered by either particle-mediated epidermal delivery (PMED), intramuscular injection (IM), or cervical intralesional injection, at study weeks 0, 4, and 8. Patients were monitored for local injection site and systemic toxicity. A standard therapeutic resection was performed at week 15. The primary endpoints were safety and tolerability. Secondary endpoints included histologic regression and change in cervical HPV viral load. Exploratory endpoints included immune responses in the blood and in the target tissue. Thirty-two patients with HPV16(+) CIN2/3 were enrolled onto the treatment phase of the study, and were vaccinated. Twenty-two of 32 patients (69%) experienced vaccine-specific related adverse events. The most frequent vaccine-related events were constitutional and local injection site in nature, and were grade 1 or less in severity. Histologic regression to CIN 1 or less occurred in 8 of 27 (30%) patients who received all vaccinations and underwent LEEP. In subject-matched comparisons, intraepithelial CD8+ T cell infiltrates increased after vaccination in subjects in the intralesional administration cohort. pNGVL4a-CRT-E7(detox) was well-tolerated, elicited the most robust immune response when administered intralesionally, and demonstrated preliminary evidence of potential clinical efficacy. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. Stakeholder cooperation: regulating a uranium mine with multiple statutory approvals

    International Nuclear Information System (INIS)

    Bush, M.

    2010-01-01

    Ranger Uranium Mine operates under an Authorisation issued by the Northern Territory Government. In addition, the site is regulated by a set of Environmental Requirements attached to the uranium export permit issued by the Australian Government Department of Resources, Energy and Tourism. A Heap Leach facility proposed for the site could result in a third approval being issued, in accordance with the Environmental Protection and Biodiversity Conservation Act 1999 (EPBC Act). Finding the correct balance to regulate the mine in light of these approvals will be a challenge for the range of stakeholders involved in regulation and oversight of this operation. (author)

  20. Proposed English Standards Promote Aviation Safety.

    Science.gov (United States)

    Chatham, Robert L.; Thomas, Shelley

    2000-01-01

    Discusses the International Civil Aviation Organization's (ICAO) Air Navigation's Commission approval of a task to develop minimum skill level requirements in English for air traffic control. The ICAO collaborated with the Defense Language Institute English Language Center to propose a minimum standard for English proficiency for international…

  1. 76 FR 22411 - Notice of Proposed Information Collection: Comment Request; Housing Counseling Program...

    Science.gov (United States)

    2011-04-21

    ... Information Collection: Comment Request; Housing Counseling Program--Application for Approval as a Housing Counseling Agency AGENCY: Office of the Assistant Secretary for Housing, HUD. ACTION: Notice. SUMMARY: The...: Title of Proposal: Housing Counseling Program--Application for Approval as a Housing Counseling Agency...

  2. 77 FR 36008 - Agency Information Collection Activities; Proposed Collection: Cargo Theft Incident Report...

    Science.gov (United States)

    2012-06-15

    ... Collection Activities; Proposed Collection: Cargo Theft Incident Report, Revision of a Currently Approved... collection: Revision of a currently approved collection. (2) The title of the form/collection: Cargo Theft... enforcement agencies. Brief Abstract: This collection is needed to collect information on cargo theft...

  3. IDEAL-CRT: A Phase 1/2 Trial of Isotoxic Dose-Escalated Radiation Therapy and Concurrent Chemotherapy in Patients With Stage II/III Non-Small Cell Lung Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Landau, David B., E-mail: david.landau@kcl.ac.uk [Guy' s & St. Thomas' NHS Trust, King' s College London, London (United Kingdom); Hughes, Laura [Cancer Research UK and UCL Cancer Trials Centre, London (United Kingdom); Baker, Angela [Clatterbridge Cancer Centre, Bebington (United Kingdom); Bates, Andrew T. [Southampton General Hospital, Southampton (United Kingdom); Bayne, Michael C. [Poole Hospital, Poole (United Kingdom); Counsell, Nicholas [Cancer Research UK and UCL Cancer Trials Centre, London (United Kingdom); Garcia-Alonso, Angel [North Wales Cancer Centre, Rhyl (United Kingdom); Harden, Susan V. [Addenbrookes Hospital, Cambridge (United Kingdom); Hicks, Jonathan D. [Beatson West of Scotland Cancer Centre, Glasgow (United Kingdom); Hughes, Simon R. [Guy' s & St. Thomas' NHS Trust, King' s College London, London (United Kingdom); Illsley, Marianne C. [Royal Surrey County Hospital, Guilford (United Kingdom); Khan, Iftekhar [Cancer Research UK and UCL Cancer Trials Centre, London (United Kingdom); Laurence, Virginia [Poole Hospital, Poole (United Kingdom); Malik, Zafar; Mayles, Helen; Mayles, William Philip M. [Clatterbridge Cancer Centre, Bebington (United Kingdom); Miles, Elizabeth [Mount Vernon Hospital, Middlesex (United Kingdom); Mohammed, Nazia [Beatson West of Scotland Cancer Centre, Glasgow (United Kingdom); Ngai, Yenting [Cancer Research UK and UCL Cancer Trials Centre, London (United Kingdom); Parsons, Emma [Mount Vernon Hospital, Middlesex (United Kingdom); and others

    2016-08-01

    Purpose: To report toxicity and early survival data for IDEAL-CRT, a trial of dose-escalated concurrent chemoradiotherapy (CRT) for non-small cell lung cancer. Patients and Methods: Patients received tumor doses of 63 to 73 Gy in 30 once-daily fractions over 6 weeks with 2 concurrent cycles of cisplatin and vinorelbine. They were assigned to 1 of 2 groups according to esophageal dose. In group 1, tumor doses were determined by an experimental constraint on maximum esophageal dose, which was escalated following a 6 + 6 design from 65 Gy through 68 Gy to 71 Gy, allowing an esophageal maximum tolerated dose to be determined from early and late toxicities. Tumor doses for group 2 patients were determined by other tissue constraints, often lung. Overall survival, progression-free survival, tumor response, and toxicity were evaluated for both groups combined. Results: Eight centers recruited 84 patients: 13, 12, and 10, respectively, in the 65-Gy, 68-Gy, and 71-Gy cohorts of group 1; and 49 in group 2. The mean prescribed tumor dose was 67.7 Gy. Five grade 3 esophagitis and 3 grade 3 pneumonitis events were observed across both groups. After 1 fatal esophageal perforation in the 71-Gy cohort, 68 Gy was declared the esophageal maximum tolerated dose. With a median follow-up of 35 months, median overall survival was 36.9 months, and overall survival and progression-free survival were 87.8% and 72.0%, respectively, at 1 year and 68.0% and 48.5% at 2 years. Conclusions: IDEAL-CRT achieved significant treatment intensification with acceptable toxicity and promising survival. The isotoxic design allowed the esophageal maximum tolerated dose to be identified from relatively few patients.

  4. Minimum Colour Differences Required To Recognise Small Objects On A Colour CRT

    Science.gov (United States)

    Phillips, Peter L.

    1985-05-01

    Data is required to assist in the assessment, evaluation and optimisation of colour and other displays for both military and general use. A general aim is to develop a mathematical technique to aid optimisation and reduce the amount of expensive hardware development and trials necessary when introducing new displays. The present standards and methods available for evaluating colour differences are known not to apply to the perception of typical objects on a display. Data is required for irregular objects viewed at small angular subtense ((1°) and relating the recognition of form rather than colour matching. Therefore laboratory experiments have been carried out using a computer controlled CRT to measure the threshold colour difference that an observer requires between object and background so that he can discriminate a variety of similar objects. Measurements are included for a variety of background and object colourings. The results are presented in the CIE colorimetric system similar to current standards used by the display engineer. Apart from the characteristic small field tritanopia, the results show that larger colour differences are required for object recognition than those assumed from conventional colour discrimination data. A simple relationship to account for object size and background colour is suggested to aid visual performance assessments and modelling.

  5. 76 FR 37867 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving...

    Science.gov (United States)

    2011-06-28

    ..., as Modified by Amendment No. 1, to Reduce the Minimum Size of the Nominating and Governance Committee... proposed rule change to reduce the minimum size of the Nominating and Governance Committee (``NGC'') from... the original proposed rule change, it had not yet obtained formal approval from its Board of Directors...

  6. Association between frequent cardiac resynchronization therapy optimization and long-term clinical response: a post hoc analysis of the Clinical Evaluation on Advanced Resynchronization (CLEAR) pilot study

    Science.gov (United States)

    Delnoy, Peter Paul; Ritter, Philippe; Naegele, Herbert; Orazi, Serafino; Szwed, Hanna; Zupan, Igor; Goscinska-Bis, Kinga; Anselme, Frederic; Martino, Maria; Padeletti, Luigi

    2013-01-01

    Aims The long-term clinical value of the optimization of atrioventricular (AVD) and interventricular (VVD) delays in cardiac resynchronization therapy (CRT) remains controversial. We studied retrospectively the association between the frequency of AVD and VVD optimization and 1-year clinical outcomes in the 199 CRT patients who completed the Clinical Evaluation on Advanced Resynchronization study. Methods and results From the 199 patients assigned to CRT-pacemaker (CRT-P) (New York Heart Association, NYHA, class III/IV, left ventricular ejection fraction failure-related hospitalization, NYHA functional class, and Quality of Life score, at 1 year. Systematic CRT optimization was associated with a higher percentage of improved patients based on the composite endpoint (85% in Group 1 vs. 61% in Group 2, P < 0.001), with fewer deaths (3% in Group 1 vs. 14% in Group 2, P = 0.014) and fewer hospitalizations (8% in Group 1 vs. 23% in Group 2, P = 0.007), at 1 year. Conclusion These results further suggest that AVD and VVD frequent optimization (at implant, at 3 and 6 months) is associated with improved long-term clinical response in CRT-P patients. PMID:23493410

  7. 77 FR 16805 - Notice of Request for Extension and Revision of a Currently Approved Information Collection...

    Science.gov (United States)

    2012-03-22

    ... Monitoring System and the Food Safety Mobile Questionnaire) AGENCY: Food Safety and Inspection Service, USDA... Safety Mobile questionnaire. The approval for this information collection is due to expire. FSIS is... post their personal contact information--mailing address, email address, and telephone number-- on the...

  8. The safety of CRT with high-dose cisplatin for head and neck cancers in a community hospital and the renal protection effect with magnesium

    International Nuclear Information System (INIS)

    Ariizumi, Yosuke; Takahashi, Ryosuke; Tateishi, Yumiko; Yamada, Masato

    2016-01-01

    To confirm the safety of CRT with cisplatin 100mg/m"2 for head and neck cancers in a community hospital in Japan and the renal protection effect with magnesium (Mg) supplementation. A retrospective review of 13 head and neck cancers (oropharynx, hypopharynx, and larynx) was conducted. The patients of the 80mgMg - group received CDDP 80mg/m"2 without Mg supplementation, and 100mgMg + group received CDDP 100mg/m"2 with Mg supplementation. Our hospital is a community hospital, therefore second and third administrations of CDDP are discontinued with a lower level of adverse effects than clinical trials. The total dose of CDDP and adverse effects of the two groups were compared. The grade 3 adverse effects were 5 (38%) with stomatitis, 3 (23%) with decreased white blood cell count, 1 (8%) with decreased platelet count, and 1 (8%) with febrile neutropenia. There was no grade 4 adverse effect. The proportion of patients who could receive 200mg/m"2 or more was higher (p = 0.0097) in the 100mgMg + group (7/7) than the 80mgMg - group (1/6). CRT with CDDP 100mg/m"2 at a community hospital in Japan is feasible, with reduction of renal toxicity by Mg supplementation. (author)

  9. 76 FR 5161 - Proposed Collection; Comment Request

    Science.gov (United States)

    2011-01-28

    ... FEDERAL HOUSING FINANCE AGENCY [No. 2011-N-02] Proposed Collection; Comment Request AGENCY: Federal Housing Finance Agency. ACTION: Submission of Information Collection for Emergency Approval from the Office of Management and Budget. SUMMARY: The Federal Housing Finance Agency (FHFA) submitted to...

  10. 19 CFR 115.41 - Certificate of approval for containers approved after manufacture.

    Science.gov (United States)

    2010-04-01

    ... after manufacture. 115.41 Section 115.41 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT... PURSUANT TO INTERNATIONAL CUSTOMS CONVENTIONS Procedures for Approval of Containers After Manufacture § 115.41 Certificate of approval for containers approved after manufacture. The Certifying Authority shall...

  11. [Newly developed monitor for IVR: liquid crystal display (LCD) replaced with cathode ray tube (CRT)].

    Science.gov (United States)

    Ichida, Takao; Hosogai, Minoru; Yokoyama, Kouji; Ogawa, Takayoshi; Okusako, Kenji; Shougaki, Masachika; Masai, Hironao; Yamada, Eiji; Okuyama, Kazuo; Hatagawa, Masakatsu

    2004-09-01

    For physicians who monitor images during interventional radiology (VR), we have built and been using a system that employs a liquid crystal display (LCD) instead of the conventional cathode ray tube (CRT). The system incorporates a ceiling-suspension-type monitor (three-display monitor) with an LCD on each of the three displays for the head and abdominal regions and another ceiling-suspension-type monitor (5-display monitor) with an LCD on each display for the cardiac region. As these monitors are made to be thin and light in weight, they can be placed in a high position in the room, thereby saving space and allowing for more effective use of space in the X-ray room. The system has also improved the efficiency of operators in the IVR room. The three-display folding mechanism allows the displays to be viewed from multiple directions, thereby improving the environment so that the performance of IVR can be observed.

  12. Longterm neurocognitive sequellae of a prospectively followed cohort of low grade tumor patients treated by conformal irradiation

    International Nuclear Information System (INIS)

    Armstrong, C.; Ruffer, J.; Hopwood, C.; Montenegro, L.; Mollman, J.; Judy, K.; Alavi, J.; Corn, B.

    1996-01-01

    Purpose/Objective: Although many advances have been made in the use of therapeutic irradiation to treat patients with brain tumors, the neurocognitive effects of conformal radiation therapy (CRT) are poorly known and controversial. Retrospective studies of radiotherapy in children and adults have revealed both leukoencephalopathy and cognitive impairments in follow-up of months to 20 years after treatment. Most prospective studies have examined neurocognitive effects at one year post CRT, and our previous findings (1993,1995) suggest that this endpoint misses the first two phases of the delayed effects of CRT. We also propose that the effects of CRT can be characterized in terms of dissociated curvilinear slopes of neurocognitive impairments, which allow specific hypotheses about the multiple phases of the delayed effects. Materials/Methods: We have examined our neurocognitive model of radiotherapy effects in our current group of 20 patients who have supratentorial, low grade, primary brain tumors. Total CRT doses ranged between 46 to 63 Gy (med. dose of 54 Gy, with fractionations of 1.8-2.0 Gy). Healthy control subjects were matched to patients with respect to age and education. Patients were tested with a comprehensive neuropsychological battery at baseline (6 weeks post resection/biopsy, immediately prior to CRT), at three month intervals for one year, and yearly; current analyses reflect three years post baseline. To test the hypothesis that long-term memory is generally impaired versus selective impairment of verbal/semantic memory processes, we used parallel tests of verbal/semantic and visual/perceptual long-term memory which require association to encode and retrieve the stimuli. The visual long-term memory test was available on 10 patients. Results: A specific treatment-dependent deficit in long-term memory retrieval of word lists was found in 18 of 20 patients at six weeks post completion of CRT, though it was a temporary impairment which rebounded by one

  13. 77 FR 31262 - Approval and Promulgation of Implementation Plans; Kentucky; Louisville; Fine Particulate Matter...

    Science.gov (United States)

    2012-05-25

    ... otherwise protected. The www.regulations.gov Web site is an ``anonymous access'' system, which means EPA... Inventory AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve the fine particulate matter (PM 2.5 ) 2002 base year emissions inventory, portion of the State...

  14. Cerebral pathology and neuropsychological effects. Differential effects of cranial radiation as a function of age

    International Nuclear Information System (INIS)

    Dowell, R.E. Jr.; Copeland, D.R.

    1987-01-01

    Cranial radiation therapy (CRT) has been associated with an increased incidence of neuropsychological impairments and pathologic changes in the CNS among children. However, findings regarding a causal relationship between CRT and neurobehavioral impairments and the differential impact of CRT as a function of treatment age have been equivocal. Inconsistent findings may be attributed to the current research focus on description of impairments to the neglect of a larger theoretical framework and the failure of investigators to integrate findings from the various disciplines involved in assessing CRT effects. Two theories regarding the etiology of CRT effects on neuropsychological functions have been proposed. The myelination hypothesis suggests that CRT effects are attributable to direct effects on myelin synthesis. Findings indicating that the child is in a state of particular vulnerability to teratogens due to the rapid growth phase of myelin during the first 48 months of life provide the basis for this hypothesis. The myelination hypothesis predicts a differential effect for CRT as a function of age/maturation. The vascular hypothesis proposes that CRT effects are due to pathological changes in vascular tissues. Results indicating prominent white matter changes among some CRT recipients provide the basis for this hypothesis. The vascular hypothesis predicts no age effect or an inverse age effect; it places more emphasis on the relationship between indices of cerebral blood flow and neuropsychological test performance. Two basic mechanisms underlying the effects of CRT are outlined to provide a theoretical framework on which future research may be based. 29 references

  15. Effects of simultaneous and optimized sequential cardiac resynchronization therapy on myocardial oxidative metabolism and efficiency.

    Science.gov (United States)

    Christenson, Stuart D; Chareonthaitawee, Panithaya; Burnes, John E; Hill, Michael R S; Kemp, Brad J; Khandheria, Bijoy K; Hayes, David L; Gibbons, Raymond J

    2008-02-01

    Cardiac resynchronization therapy (CRT) can improve left ventricular (LV) hemodynamics and function. Recent data suggest the energy cost of such improvement is favorable. The effects of sequential CRT on myocardial oxidative metabolism (MVO(2)) and efficiency have not been previously assessed. Eight patients with NYHA class III heart failure were studied 196 +/- 180 days after CRT implant. Dynamic [(11)C]acetate positron emission tomography (PET) and echocardiography were performed after 1 hour of: 1) AAI pacing, 2) simultaneous CRT, and 3) sequential CRT. MVO(2) was calculated using the monoexponential clearance rate of [(11)C]acetate (k(mono)). Myocardial efficiency was expressed in terms of the work metabolic index (WMI). P values represent overall significance from repeated measures analysis. Global LV and right ventricular (RV) MVO(2) were not significantly different between pacing modes, but the septal/lateral MVO(2) ratio differed significantly with the change in pacing mode (AAI pacing = 0.696 +/- 0.094 min(-1), simultaneous CRT = 0.975 +/- 0.143 min(-1), and sequential CRT = 0.938 +/- 0.189 min(-1); overall P = 0.001). Stroke volume index (SVI) (AAI pacing = 26.7 +/- 10.4 mL/m(2), simultaneous CRT = 30.6 +/- 11.2 mL/m(2), sequential CRT = 33.5 +/- 12.2 mL/m(2); overall P simultaneous CRT = 4.29 +/- 1.72 mmHg*mL/m(2)*10(6), sequential CRT = 4.79 +/- 1.92 mmHg*mL/m(2)*10(6); overall P = 0.002) also differed between pacing modes. Compared with simultaneous CRT, additional changes in septal/lateral MVO(2), SVI, and WMI with sequential CRT were not statistically significant on post hoc analysis. In this small selected population, CRT increases LV SVI without increasing MVO(2), resulting in improved myocardial efficiency. Additional improvements in LV work, oxidative metabolism, and efficiency from simultaneous to sequential CRT were not significant.

  16. 24 CFR 941.303 - Site acquisition proposal.

    Science.gov (United States)

    2010-04-01

    ... rezoning is likely and will not delay the project. (d) Development schedule. A copy of the PHA development... stage. (e) Environmental assessment. All available environmental information on the proposed development... effective until approval has been given by the Office of Management and Budget. ...

  17. 78 FR 63204 - Proposed Collection; Comment Request

    Science.gov (United States)

    2013-10-23

    ... Office of Management and Budget, Attention: Desk Officer for the Federal Housing Finance Agency... FEDERAL HOUSING FINANCE AGENCY [No. 2013-N-12] Proposed Collection; Comment Request AGENCY: Federal Housing Finance Agency. ACTION: 30-day Notice of Submission of Information Collection for Approval...

  18. 75 FR 40834 - Proposed Collection; Comment Request

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    2010-07-14

    ... of Management and Budget, Attention: Desk Officer for the Federal Housing Finance Agency, Washington... FEDERAL HOUSING FINANCE AGENCY [No. 2010-N-08] Proposed Collection; Comment Request AGENCY: Federal Housing Finance Agency. ACTION: 30-day Notice of Submission of Information Collection for Approval...

  19. 75 FR 82119 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of...

    Science.gov (United States)

    2010-12-29

    ..., the Board's basic fair practice rule, to apply the rules to municipal advisors. The proposed rule... Independent Public Finance Advisors, dated December 9, 2010. This order approves the proposed rule change. II... of which may have a substantial impact on the finances of those municipal entities. In other cases...

  20. 77 FR 49830 - Proposed Collection, Comments Requested: FBI National Academy Post-Course Questionnaire for...

    Science.gov (United States)

    2012-08-17

    ... request to the Office of Management and Budget (OMB) for review and approval in accordance with the... Laleatha B. Goode, Management and Program Analyst for the Evaluation Program, Federal Bureau of... measure the effectiveness of services that the FBI National Academy provides and will utilize the...

  1. Students' cross-racial interaction in post-apartheid South African

    African Journals Online (AJOL)

    student perspectives and Critical Race Theory (CRT), this qualitative exploration .... apartheid was dismantled, Afrikaans-medium universities adopted a dual language .... coding (Strauss and Corbin, 1990) to identify areas that pertained to the ...

  2. A Document Imaging Technique for Implementing Electronic Loan Approval Process

    Directory of Open Access Journals (Sweden)

    J. Manikandan

    2015-04-01

    Full Text Available The image processing is one of the leading technologies of computer applications. Image processing is a type of signal processing, the input for image processor is an image or video frame and the output will be an image or subset of image [1]. Computer graphics and computer vision process uses an image processing techniques. Image processing systems are used in various environments like medical fields, computer-aided design (CAD, research fields, crime investigation fields and military fields. In this paper, we proposed a document image processing technique, for establishing electronic loan approval process (E-LAP [2]. Loan approval process has been tedious process, the E-LAP system attempts to reduce the complexity of loan approval process. Customers have to login to fill the loan application form online with all details and submit the form. The loan department then processes the submitted form and then sends an acknowledgement mail via the E-LAP to the requested customer with the details about list of documents required for the loan approval process [3]. The approaching customer can upload the scanned copies of all required documents. All this interaction between customer and bank take place using an E-LAP system.

  3. Real-world evidence analysis of palbociclib prescribing patterns for patients with advanced/metastatic breast cancer treated in community oncology practice in the USA one year post approval.

    Science.gov (United States)

    Kish, J K; Ward, M A; Garofalo, D; Ahmed, H V; McRoy, L; Laney, J; Zanotti, G; Braverman, J; Yu, H; Feinberg, B A

    2018-05-02

    Rapidly evolving understanding of cancer biology has presented novel opportunities to translate that understanding into clinically relevant therapy. Palbociclib, a novel, first-in-class cyclin-dependent kinase (CDK) 4/6 inhibitor was approved in the USA in February 2015 for the treatment of advanced/metastatic breast cancer. We examined real-world evidence in the first year post approval to understand the clinical and demographic characteristics of patients treated with palbociclib in community oncology practices and the dosing, treatment, and complete blood count (CBC) monitoring patterns. This was a retrospective observational study of structured data from a US electronic medical record (EMR) database. Female patients receiving palbociclib after 31 January 2015 were followed through 31 March 2016. Our methodological rules were constructed to aggregate drugs received according to the order in which they are given, i.e., identify the line of therapy as first, second, or third line, etc., using treatment order and course description fields from the EMR. There were 763 patients initiating palbociclib who met the selection criteria. Of those, 612 (80.2%) received palbociclib concomitantly with letrozole. Mean follow up was 6.4 months and mean age at palbociclib initiation was 64 years. Of patients with a known starting dose (n = 417), 79.9% started on palbociclib 125 mg. Dose reductions were observed in 20.1% of patients. Percentages of patients according to line of therapy at initiation of palbociclib were first-line, 39.5%; second-line, 15.7%; third-line, 13.1%; and fourth-line therapy or later, 31.7%. On average, two CBC tests were conducted during the first cycle of palbociclib treatment. Overall, 74.6% of patients had a neutropenic event during follow up including 47.3% and 8.0% of patients with a grade 3 or 4 occurrence, respectively. Real-world palbociclib use one year post US approval demonstrates a more heterogeneous patient population than that

  4. Reliability Of A Novel Intracardiac Electrogram Method For AV And VV Delay Optimization And Comparability To Echocardiography Procedure For Determining Optimal Conduction Delays In CRT Patients

    Directory of Open Access Journals (Sweden)

    N Reinsch

    2009-03-01

    Full Text Available Background: Echocardiography is widely used to optimize CRT programming. A novel intracardiac electrogram method (IEGM was recently developed as an automated programmer-based method, designed to calculate optimal atrioventricular (AV and interventricular (VV delays and provide optimized delay values as an alternative to standard echocardiographic assessment.Objective: This study was aimed at determining the reliability of this new method. Furthermore the comparability of IEGM to existing echocardiographic parameters for determining optimal conduction delays was verified.Methods: Eleven patients (age 62.9± 8.7; 81% male; 73% ischemic, previously implanted with a cardiac resynchronisation therapy defibrillator (CRT-D underwent both echocardiographic and IEGM-based delay optimization.Results: Applying the IEGM method, concordance of three consecutively performed measurements was found in 3 (27% patients for AV delay and in 5 (45% patients for VV delay. Intra-individual variation between three measurements as assessed by the IEGM technique was up to 20 ms (AV: n=6; VV: n=4. E-wave, diastolic filling time and septal-to-lateral wall motion delay emerged as significantly different between the echo and IEGM optimization techniques (p < 0.05. The final AV delay setting was significantly different between both methods (echo: 126.4 ± 29.4 ms, IEGM: 183.6 ± 16.3 ms; p < 0.001; correlation: R = 0.573, p = 0.066. VV delay showed significant differences for optimized delays (echo: 46.4 ± 23.8 ms, IEGM: 10.9 ± 7.0 ms; p <0.01; correlation: R = -0.278, p = 0.407.Conclusion: The automated programmer-based IEGM-based method provides a simple and safe method to perform CRT optimization. However, the reliability of this method appears to be limited. Thus, it remains difficult for the examiner to determine the optimal hemodynamic settings. Additionally, as there was no correlation between the optimal AV- and VV-delays calculated by the IEGM method and the echo

  5. 77 FR 21911 - Approval and Promulgation of Implementation Plans; State of Arizona; Prevention of Air Pollution...

    Science.gov (United States)

    2012-04-12

    ...EPA is proposing to approve the State Implementation Plan (SIP) revision submitted by the State of Arizona to address the requirements regarding air pollution emergency episodes in Clean Air Act (CAA or Act) section 110(a)(2)(G). Section 110(a)(2)(G) of the Act requires that each SIP provide for authority comparable to that in section 303 of the Act and adequate contingency plans to implement such authority. EPA is proposing to approve Arizona's SIP revision as meeting the authority and contingency plans for the 1997 8-hour ozone National Ambient Air Quality Standards (NAAQS or standards).

  6. Is Asia a 'Post-Religional' Society? The Post-Religional Paradigm and its Others

    Directory of Open Access Journals (Sweden)

    Daniel Franklin Estepa Pilario

    2015-04-01

    Full Text Available This article discusses the relevance and applicability of the 'post-religional paradigm' as proposed by EATWOT (Ecumenical Association of Third World Theologians in the Asian contexts. It also inquires on how the Asian phenomenon and its interpretations relate to the crisis of religions in Western societies. It attempts to answer this problematic through four steps: a summary of the theological proposal and its relationship with the Western sociologies of religion; a search for a viable framework with which to understand religions in post-secular societies; discussion on the "discourses of Asia" and the corresponding view on religion; an elaboration of my preferred framework with some examples from the Asian situation. I argue that a viable theological proposal on post-religional paradigm should start from the analysis of how religious discourses and practices navigate with concrete socio-historical forces on the ground. Consequent to this view is the assertion that there is no universal sociology/theology of religion's development but multiple and complex religious discourses in specific contexts.

  7. 46 CFR 169.849 - Posting placards containing instructions for launching and inflating inflatable liferafts.

    Science.gov (United States)

    2010-10-01

    ... Inspections § 169.849 Posting placards containing instructions for launching and inflating inflatable... accessible to the ship's company and guests approved placards containing instructions for launching and... determined by the Officer in Charge, Marine Inspection. ...

  8. Classification of sudden and arrhythmic death

    DEFF Research Database (Denmark)

    Torp-Pedersen, C; Køber, L; Elming, H

    1997-01-01

    was nearly abolished by the implantable defibrillator, indicating that arrhythmic death by this classification is meaningful, at least in the population studied. For future investigations, a call is made for committees to present data in a way that allows the reader to examine the quality of the data used......Since all death is (eventually) sudden and associated with cardiac arrhythmias, the concept of sudden death is only meaningful if it is unexpected, while arrhythmic death is only meaningful if life could have continued had the arrhythmia been prevented or treated. Current classifications of death...... or autopsy) are available in only a few percent of cases. A main problem in using classifications is the lack of validation data. This situation has, with the MADIT trial, changed in the case of the Thaler and Hinkle classification of arrhythmic death. The MADIT trial demonstrated that arrhythmic death...

  9. Ethics in action: Approving and improving medical research with human subjects

    NARCIS (Netherlands)

    de Jong, J.P.

    2013-01-01

    In this thesis, Jean Philippe de Jong presents a new understanding of ethical oversight on medical research with human subjects and proposes that two philosophies for ethical oversight exist: '(dis)approving' and 'improving'. Systems for ethical oversight on medical research have been in place for

  10. Clinical utility of pretreatment prediction of chemoradiotherapy response in rectal cancer: a review.

    Science.gov (United States)

    Yoo, Byong Chul; Yeo, Seung-Gu

    2017-03-01

    Approximately 20% of all patients with locally advanced rectal cancer experience pathologically complete responses following neoadjuvant chemoradiotherapy (CRT) and standard surgery. The utility of radical surgery for patients exhibiting good CRT responses has been challenged. Organ-sparing strategies for selected patients exhibiting complete clinical responses include local excision or no immediate surgery. The subjects of this tailored management are patients whose presenting disease corresponds to current indications of neoadjuvant CRT, and their post-CRT tumor response is assessed by clinical and radiological examinations. However, a model predictive of the CRT response, applied before any treatment commenced, would be valuable to facilitate such a personalized approach. This would increase organ preservation, particularly in patients for whom upfront CRT is not generally prescribed. Molecular biomarkers hold the greatest promise for development of a pretreatment predictive model of CRT response. A combination of clinicopathological, radiological, and molecular markers will be necessary to render the model robust. Molecular research will also contribute to the development of drugs that can overcome the radioresistance of rectal tumors. Current treatments for rectal cancer are based on the expected prognosis given the presenting disease extent. In the future, treatment schemes may be modified by including the predicted CRT response evaluated at presentation.

  11. 75 FR 60435 - Proposed Collection; Comment Request

    Science.gov (United States)

    2010-09-30

    ..., including through the use of automated collection techniques or other forms of information technology. DATES... 3502(c)(2)(A) of the Paperwork Reduction Act of 1995, the Chief of Naval Education and Training announces a proposed extension of a previously approved public information collection and seeks public...

  12. Indicators for Universal Health Coverage: can Kenya comply with the proposed post-2015 monitoring recommendations?

    Science.gov (United States)

    Obare, Valerie; Brolan, Claire E; Hill, Peter S

    2014-12-20

    Universal Health Coverage (UHC), referring to access to healthcare without financial burden, has received renewed attention in global health spheres. UHC is a potential goal in the post-2015 development agenda. Monitoring of progress towards achieving UHC is thus critical at both country and global level, and a monitoring framework for UHC was proposed by a joint WHO/World Bank discussion paper in December 2013. The aim of this study was to determine the feasibility of the framework proposed by WHO/World Bank for global UHC monitoring framework in Kenya. The study utilised three documents--the joint WHO/World Bank UHC monitoring framework and its update, and the Bellagio meeting report sponsored by WHO and the Rockefeller Foundation--to conduct the research. These documents informed the list of potential indicators that were used to determine the feasibility of the framework. A purposive literature search was undertaken to identify key government policy documents and relevant scholarly articles. A desk review of the literature was undertaken to answer the research objectives of this study. Kenya has yet to establish an official policy on UHC that provides a clear mandate on the goals, targets and monitoring and evaluation of performance. However, a significant majority of Kenyans continue to have limited access to health services as well as limited financial risk protection. The country has the capacity to reasonably report on five out of the seven proposed UHC indicators. However, there was very limited capacity to report on the two service coverage indicators for the chronic condition and injuries (CCIs) interventions. Out of the potential tracer indicators (n = 27) for aggregate CCI-related measures, four tracer indicators were available. Moreover the country experiences some wider challenges that may impact on the implementation and feasibility of the WHO/World Bank framework. The proposed global framework for monitoring UHC will only be feasible in Kenya if

  13. 78 FR 46314 - Request for Revision of a Currently Approved Information Collection

    Science.gov (United States)

    2013-07-31

    ... development and job creation projects such as business start-up costs, business expansion, community... DEPARTMENT OF AGRICULTURE Rural Business-Cooperative Service Request for Revision of a Currently Approved Information Collection AGENCY: Rural Business-Cooperative Service, USDA. ACTION: Notice; proposed...

  14. Post-Closure Inspection Report for Corrective Action Unit 453: Area 9 UXO Landfill Tonopah Test Range, Nevada, Calendar Year 2000; TOPICAL

    International Nuclear Information System (INIS)

    K. B. Campbell

    2001-01-01

    Post-closure monitoring requirements for the Area 9 Unexploded Ordnance Landfill (Corrective Action Unit[CAU] 453) (Figure 1) are described in Closure Report for Corrective Action Unit 453: Area 9 UXO Landfill, Tonopah Test Range, Nevada, report number DOE/NV-284. The Closure Report (CR) was submitted to the Nevada Division of Environmental Protection (NDEP) on August 5,1999. The CR (containing the Post-Closure Monitoring Plan) was approved by the NDEP on September 10,1999. Post-closure monitoring at CAU 453 consists of the following: (1) Site inspections done twice a year to evaluate the condition of the unit; (2) Verification that the site is secure; (3) Notice of any subsidence or deficiencies that may compromise the integrity of the unit; (4) Remedy of any deficiencies within 90 days of discovery; and (5) Preparation and submittal of an annual report. Site inspections were conducted on June 20, 2000 and November 21, 2000. Both site inspections were conducted after NDEP approval of the CR, and in accordance with the Post-Closure Monitoring Plan in the NDEP-approved CR. This report includes copies of the inspection checklists, photographs, recommendations, and conclusions. The Post-Closure Inspection Checklists are found in Attachment A, a copy of the field notes is found in Attachment B, and inspection photographs are found in Attachment C

  15. 75 FR 60341 - Licenses, Certifications, and Approvals for Material Licensees; Reopening of Comment Period

    Science.gov (United States)

    2010-09-30

    ... approval processes for byproduct, source and special nuclear material licenses, and irradiators to clarify... review the proposed amendment in order to provide constructive comments, an extension was necessary. No...

  16. 49 CFR 107.705 - Registrations, reports, and applications for approval.

    Science.gov (United States)

    2010-10-01

    ... format may be filed by facsimile (fax) to: (202) 366-3753 or (202) 366-3308 or by electronic mail (e-mail... mailing addresses, e-mail address optional, and telephone number of the person on whose behalf the... proposed duration of the approval; (3) The transport mode or modes affected, as applicable; (4) Any...

  17. Magnetic resonance imaging-detected extramural venous invasion in rectal cancer before and after preoperative chemoradiotherapy. Diagnostic performance and prognostic significance

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Eun Sun [Chung-Ang University Hospital, Department of Radiology, Seoul (Korea, Republic of); Chung-Ang University, College of Medicine and Graduate School of Medicine, Seoul (Korea, Republic of); National Cancer Centre, Department of Radiology, Goyang-si, Gyeonggi-do (Korea, Republic of); Kim, Min Ju; Hur, Bo Yun [National Cancer Centre, Department of Radiology, Goyang-si, Gyeonggi-do (Korea, Republic of); Park, Sung Chan; Hyun, Jong Hee; Chang, Hee Jin; Baek, Ji Yeon; Kim, Dae Yong; Oh, Jae Hwan [National Cancer Centre, Centre for Colorectal Cancer, Goyang, Gyeonggi-do (Korea, Republic of); Kim, Sun Young [National Cancer Centre, Centre for Colorectal Cancer, Goyang, Gyeonggi-do (Korea, Republic of); University of Ulsan College of Medicine, Department of Oncology, Asan Medical Centre, Seoul (Korea, Republic of)

    2018-02-15

    We evaluated the diagnostic performance of magnetic resonance imaging (MRI) in terms of identifying extramural venous invasion (EMVI) in rectal cancer patients with preoperative chemoradiotherapy (CRT) and its prognostic significance. During 2008-2010, 200 patients underwent surgery following preoperative CRT for rectal cancer. Two radiologists independently reviewed all pre- and post-CRT MRI retrospectively. We investigated diagnostic performance of pre-CRT MR-EMVI (MR-EMVI) and post-CRT MR-EMVI (yMR-EMVI), based on pathological EMVI as the standard of reference. We assessed correlation between MRI findings and patients' prognosis, such as disease-free survival (DFS) and overall survival (OS). Additionally, subgroup analysis in MR- or yMR-EMVI-positive patients was performed to confirm the significance of the severity of EMVI in MRI on patient's prognosis. The sensitivity and specificity of yMR-EMVI were 76.19% and 79.75% (area under the curve: 0.830), respectively. In univariate analysis, yMR-EMVI was the only significant MRI factor in DFS (P = 0.027). The mean DFS for yMR-EMVI (+) patients was significantly less than for yMR-EMVI (-) patients: 57.56 months versus 72.46 months. yMR-EMVI demonstrated good diagnostic performance. yMR-EMVI was the only significant EMVI-related MRI factor that correlated with patients' DFS in univariate analysis; however, it was not significant in multivariate analysis. (orig.)

  18. 76 FR 48101 - Petition for Approval of Alternate; Odometer Disclosure Requirements

    Science.gov (United States)

    2011-08-08

    ... implement an electronic vehicle title transfer system, the State of Florida has petitioned for approval of... certificate of title for transfers of motor vehicles. With electronic titling there would not be a paper... proposed alternate disclosure requirements for vehicle transfers involving casual or private sales. NHTSA...

  19. Redfield Energy Approval

    Science.gov (United States)

    This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-This October 27, 2016 letter from EPA approves the petition from Redfield Energy, LLC, regarding non-grandfathered ethanol produced

  20. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.

    Science.gov (United States)

    DiMasi, Joseph A

    2013-06-01

    Much of the literature on trends and factors affecting biopharmaceutical innovation has focused overwhelmingly on the development and approval of never-before approved drugs and biologics. Little attention has been paid to new uses for already-approved compounds, which can be an important form of innovation. This paper aimed to determine and analyze recent trends in the number and type of new or modified US indication approvals for drugs and biologics. We also examine regulatory approval-phase times for new-use efficacy supplements and compare them to approval-phase times for original-use approvals over the same period. We developed a data set of efficacy supplements approved by the US Food and Drug Administration (FDA) from 1998 to 2011 that includes information on the type, approval-phase time (time from submission to the FDA of an application for marketing approval to approval of the application), and FDA therapeutic-significance rating for the approved application, which we obtained from an FDA Web site. This data set was merged with a Tufts Center for the Study of Drug Development (CSDD) data set of US new drug and biologics approvals. We developed descriptive statistics on trends in the number and type of new-use efficacy supplements, on US regulatory approval-phase times for the supplements, and on original new drug and biologics approvals over the study period and for the time from original- to new-use approval. The total number of new-use efficacy-supplement approvals did not exhibit a marked trend, but the number of new pediatric-indication approvals increased substantially. Approval-phase times for new-use supplements varied by therapeutic class and FDA therapeutic-significance rating. Mean approval-phase times were highest for central nervous system compounds (13.8 months) and lowest for antineoplastics (8.9 months). The mean time from original to supplement approval was substantially longer for new pediatric indications than for other new uses. Mean

  1. T2-weighted signal intensity-selected volumetry for prediction of pathological complete response after preoperative chemoradiotherapy in locally advanced rectal cancer.

    Science.gov (United States)

    Kim, Sungwon; Han, Kyunghwa; Seo, Nieun; Kim, Hye Jin; Kim, Myeong-Jin; Koom, Woong Sub; Ahn, Joong Bae; Lim, Joon Seok

    2018-06-01

    To evaluate the diagnostic value of signal intensity (SI)-selected volumetry findings in T2-weighted magnetic resonance imaging (MRI) as a potential biomarker for predicting pathological complete response (pCR) to preoperative chemoradiotherapy (CRT) in patients with rectal cancer. Forty consecutive patients with pCR after preoperative CRT were compared with 80 age- and sex-matched non-pCR patients in a case-control study. SI-selected tumor volume was measured on post-CRT T2-weighted MRI, which included voxels of the treated tumor exceeding the SI (obturator internus muscle SI + [ischiorectal fossa fat SI - obturator internus muscle SI] × 0.2). Three blinded readers independently rated five-point pCR confidence scores and compared the diagnostic outcome with SI-selected volumetry findings. The SI-selected volumetry protocol was validated in 30 additional rectal cancer patients. The area under the receiver-operating characteristic curve (AUC) of SI-selected volumetry for pCR prediction was 0.831, with an optimal cutoff value of 649.6 mm 3 (sensitivity 0.850, specificity 0.725). The AUC of the SI-selected tumor volume was significantly greater than the pooled AUC of readers (0.707, p volumetry in post-CRT T2-weighted MRI can help predict pCR after preoperative CRT in patients with rectal cancer. • Fibrosis and viable tumor MRI signal intensities (SIs) are difficult to distinguish. • T2 SI-selected volumetry yields high diagnostic performance for assessing pathological complete response. • T2 SI-selected volumetry is significantly more accurate than readers and non-SI-selected volumetry. • Post-chemoradiation therapy T2-weighted MRI SI-selected volumetry facilitates prediction of pathological complete response.

  2. Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com.

    Directory of Open Access Journals (Sweden)

    Derek So

    Full Text Available Although there are a number of online platforms for patient-level clinical trial data sharing from industry sponsors, they are not very harmonized regarding the role of local ethics approval in the research proposal review process. The first and largest of these platforms is ClinicalStudyDataRequest.com (CSDR, which includes over three thousand trials from thirteen sponsors including GlaxoSmithKline, Novartis, Roche, Sanofi, and Bayer. CSDR asks applicants to state whether they have received ethics approval for their research proposal, but in most cases does not require that they submit evidence of approval. However, the website does require that applicants without ethical approval state the reason it was not required. In order to examine the perspectives of researchers on this topic, we coded every response to that question received by CSDR between June 2014 and February 2017. Of 111 applicants who stated they were exempt from ethics approval, 63% mentioned de-identification, 57% mentioned the use of existing data, 33% referred to local or jurisdictional regulations, and 20% referred to the approvals obtained by the original study. We conclude by examining the experience of CSDR within the broader context of the access mechanisms and policies currently being used by other data sharing platforms, and discuss how our findings might be used to help clinical trial data providers design clear and informative access documents.

  3. Proposal to Include Electrical Energy in the Industrial Return Statistics

    CERN Document Server

    2003-01-01

    At its 108th session on the 20 June 1997, the Council approved the Report of the Finance Committee Working Group on the Review of CERN Purchasing Policy and Procedures. Among other topics, the report recommended the inclusion of utility supplies in the calculation of the return statistics as soon as the relevant markets were deregulated, without reaching a consensus on the exact method of calculation. At its 296th meeting on the 18 June 2003, the Finance Committee approved a proposal to award a contract for the supply of electrical energy (CERN/FC/4693). The purpose of the proposal in this document is to clarify the way electrical energy will be included in future calculations of the return statistics. The Finance Committee is invited: 1. to agree that the full cost to CERN of electrical energy (excluding the cost of transport) be included in the Industrial Service return statistics; 2. to recommend that the Council approves the corresponding amendment to the Financial Rules set out in section 2 of this docum...

  4. Prospective subjective evaluation of swallowing function and dietary pattern in head and neck cancers treated with concomitant chemo-radiation

    Directory of Open Access Journals (Sweden)

    Agarwal Jaiprakash

    2010-01-01

    Full Text Available Aim : Prospective subjective evaluation of swallowing function and dietary pattern in locally advanced head and neck cancer patients treated with concomitant chemo-radiotherapy (CRT. Materials and Methods : Prospective evaluation of swallowing function with performance status scale for head and neck cancer patients (PSSHN at pre-CRT, CRT completion and at subsequent follow-ups in adult with loco-regionally advanced head and neck squamous cell carcinoma (HNSCC patients. Results : In 47 patients (40 male, seven females; mean age 53; 72% smoker 53%, oropharyngeal cancer, the mean total PSSHN score at pre-CRT was 258.5 and decreased to 225.2 and 219.2 at two and six months respectively. Understandability of speech, normalcy in diet and eating in public at pre-CRT and six months were 91.5 and 84.4; 80.4 and 63.1; 87.3 and 76.6 respectively. In univariate analysis, pre-CRT PSSHN scores were significantly lesser in patients with severe pre-CRT dysphagia (P = 0.001, hypopharyngeal cancer (P = 0.244 and advanced T-stage (T3/4 disease (P = 0.144. At CRT completion, there was significant reduction of PSSHN scores in patients with severe pre-CRT dysphagia (P = 0.008, post-CRT weight loss (>10% and disease progression (P = 0.039. At two months and six months, 17 (57% and 11 (73.5% patients respectively showed change in dietary habit. Mean increase in meal time was 13% and 21% at two and six-month follow-up. Conclusions : HNSCC patients show deterioration in swallowing function after CRT with normalcy of diet in maximum and eating in public least affected. Pre-CRT severity of dysphagia, weight loss> 10% and disease progression have significant correlation with higher swallowing function deterioration after CRT.

  5. Environmental assessment, proposed generating station for Darlington

    International Nuclear Information System (INIS)

    1975-04-01

    This document indicates the intention of Ontario Hydro to seek approval from the Provincial Government for its plan to construct and operate a 3400 MWe nuclear generating station at the Darlington site, west of Bowmanville. This preliminary proposal also contains the environmental assessment. The environmental section of this proposal describes and assesses the existing environment and the environmental influences which would occur due to the construction and operation of a nuclear generating station, consisting of four 850 MW units, at the Darlington site. This proposed station is similar to the Bruce GS A station presently under construction. (author)

  6. Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

    Science.gov (United States)

    Ghobadi, Comeron W; Hayman, Emily L; Finkle, Joshua H; Walter, Jessica R; Xu, Shuai

    2017-01-01

    The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  7. A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus.

    Science.gov (United States)

    Ekins, Sean; Freundlich, Joel S; Coffee, Megan

    2014-01-01

    We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35). When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested.

  8. Symptom management in complex post-traumatic stress disorder (ICD-11), view and experience of patients and their relatives: a mixed methods approach (Research Proposal).

    Science.gov (United States)

    Stadtmann, Manuel P; Maercker, Andreas; Binder, Jochen; Schnepp, Wilfried

    2017-09-07

    Using the framework of IDC-11, complex post-traumatic stress disorder will be diagnosed using the core criteria of a post-traumatic stress disorder and the presence of at least one symptom from the following three domains: symptoms of emotional dysregulation, negative self-concept, and problems in interpersonal relationships. In the literature, these symptoms are discussed as a common reason for seeking treatment. The symptoms can influence and impair the quality of life. This article describes a mixed methods study with a sequential exploratory design. The aim is to describe specific patient characteristics, levels of symptom burden and perspectives of adult inpatients and to describe the experiences, views and needs of patients' relatives. The study will also investigate facilitators of and barriers to symptom management. The research will be conducted in four phases. The first phase will assess patients' symptom burdens. The second phase will use semi-structured interviews to explore attitudes to symptom management and perceptions of patients and their relatives. The third phase will statistically explore hypotheses generated after the qualitative interviews. The fourth phase will mix the quantitative and qualitative results and interpret critically. The present study will add new results to the growing literature on complex post-traumatic stress disorder. These results could serve as the basis for further research into the development of interventions to improve symptom management. Trial registration Ethical approval has been obtained from the Swiss cantonal ethic commission (Nr. 201500096). This research was also registered to the World Health Organization Clinical Trials Search Portal through the German Clinical Trial Register, Trial DRKS00012268 (21/04/2017).

  9. 77 FR 27529 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Granting Accelerated Approval of...

    Science.gov (United States)

    2012-05-10

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66922; File No. SR-ICC-2012-05] Self-Regulatory... Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed... of the Comptroller of the Currency, U.K. Financial Services Authority, or any other regulatory body...

  10. 30 CFR 18.95 - Approval of machines constructed of components approved, accepted or certified under Bureau of...

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval of machines constructed of components... APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.95 Approval of machines constructed of components approved...

  11. 78 FR 78310 - Approval and Promulgation of Implementation Plans; North Carolina; Transportation Conformity...

    Science.gov (United States)

    2013-12-26

    ...] Approval and Promulgation of Implementation Plans; North Carolina; Transportation Conformity Memorandum of... Resources. This submission adopts a memorandum of agreement establishing transportation conformity criteria...-related control measures and mitigation measures. This proposed action streamlines the conformity process...

  12. 76 FR 66344 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2011-10-26

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). For convenience...

  13. 75 FR 17456 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-04-06

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission... terms. For more information about the rulebook consolidation process, see Information Notice, March 12...

  14. Drugs Approved for Breast Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Breast Cancer This page lists cancer drugs approved by the ... are not listed here. Drugs Approved to Prevent Breast Cancer Evista (Raloxifene Hydrochloride) Raloxifene Hydrochloride Tamoxifen Citrate Drugs ...

  15. Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan.

    Science.gov (United States)

    Mori, Jinichi; Tanimoto, Tetsuya; Miura, Yuji; Kami, Masahiro

    2015-06-01

    All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry. We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action. Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance. All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  16. Post-Closure Inspection Report for Corrective Action Unit 427: Septic Waste Systems 2 and 6 Tonopah Test Range, Nevada Calendar Year 2000; TOPICAL

    International Nuclear Information System (INIS)

    K. B. Campbell

    2001-01-01

    Post-closure inspection requirements for the Area 3 Septic Waste Systems 2 and 6 (Corrective Action Unit[CAU] 427) (Figure 1) are described in Closure Report for Corrective Action Unit 427. Area 3 Septic Waste Systems 2 and 6. Tonopah Test Range, Nevada, report number DOE/NV-561. The Closure Report (CR) was submitted to the Nevada Division of Environmental Protection (NDEP) on August 16, 1999. The CR (containing the Post-Closure Inspection Plan) was approved by the NDEP on August 27, 1999. The annual post-closure inspection at CAU 427 consists of the following: Verification of the presence of all leachfield and septic tank below-grade markers; Verification that the warning signs are in-place, intact, and readable; and Visual observation of the soil and asphalt cover for indications of subsidence, erosion, and unauthorized use. The site inspections were conducted on June 20, 2000, and November 21, 2000. All inspections were made after NDEP approval of the CR and were conducted in accordance with the Post-Closure Inspection Plan in the NDEP-approved CR. No maintenance or repairs were conducted at the site. This report includes copies of inspection checklists, photographs, recommendations, and conclusions. Copies of the Post-Closure Inspection Checklists are found in Attachment A, a copy of the field notes is found in Attachment B, and a copy of the inspection photographs is found in Attachments C

  17. 77 FR 26706 - Food Ingredients and Sources of Radiation Listed and Approved for Use in the Production of Meat...

    Science.gov (United States)

    2012-05-07

    ... Listed and Approved for Use in the Production of Meat and Poultry Products AGENCY: Food Safety and... the regulations prohibit for use in meat or poultry products. Under this proposal, new uses of these substances in meat or poultry products would continue to be approved by the Food and Drug Administration (FDA...

  18. 78 FR 46405 - Agency Information Collection Activities: Requests for Comments; Clearance of a New Approval of...

    Science.gov (United States)

    2013-07-31

    ... to be collected will be used to conduct a benefit cost analysis in connection with rulemaking as... cost and benefit estimate of the proposed rule. The FAA requests your comments on the proposed... invites public comments about our intention to request the Office of Management and Budget (OMB) approval...

  19. 78 FR 75671 - Agency Information Collection Activities: Requests for Comments; Clearance of a New Approval of...

    Science.gov (United States)

    2013-12-12

    ... collected will be used to conduct a benefit cost analysis in connection with rulemaking as required by... cost and benefit estimate of the proposed rule. The FAA requests comments on the proposed questions... invites public comments about our intention to request the Office of Management and Budget (OMB) approval...

  20. Drugs Approved for Thyroid Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Thyroid Cancer Cabozantinib-S-Malate Caprelsa (Vandetanib) Cometriq (Cabozantinib-S-Malate) Doxorubicin ...

  1. REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

    International Nuclear Information System (INIS)

    Markman, D.W.

    1999-01-01

    Preliminary design concepts for the proposed Subsurface Repository at Yucca Mountain indicate extensive reliance on modern, computer-based, digital control technologies. The purpose of this analysis is to investigate the degree to which the U. S. Nuclear Regulatory Commission (NRC) has accepted and approved the use of digital control technology for safety-related applications within the nuclear power industry. This analysis reviews cases of existing digitally-based control systems that have been approved by the NRC. These cases can serve as precedence for using similar types of digitally-based control technologies within the Subsurface Repository. While it is anticipated that the Yucca Mountain Project (YMP) will not contain control systems as complex as those required for a nuclear power plant, the review of these existing NRC approved applications will provide the YMP with valuable insight into the NRCs review process and design expectations for safety-related digital control systems. According to the YMP Compliance Program Guidance, portions of various NUREGS, Regulatory Guidelines, and nuclear IEEE standards the nuclear power plant safety related concept would be applied to some of the designs on a case-by-case basis. This analysis will consider key design methods, capabilities, successes, and important limitations or problems of selected control systems that have been approved for use in the Nuclear Power industry. An additional purpose of this analysis is to provide background information in support of further development of design criteria for the YMP. The scope and primary objectives of this analysis are to: (1) Identify and research the extent and precedence of digital control and remotely operated systems approved by the NRC for the nuclear power industry. Help provide a basis for using and relying on digital technologies for nuclear related safety critical applications. (2) Identify the basic control architecture and methods of key digital control

  2. 78 FR 16619 - List of Approved Spent Fuel Storage Casks: MAGNASTOR® System

    Science.gov (United States)

    2013-03-18

    ...-0308] RIN 3150-AJ22 List of Approved Spent Fuel Storage Casks: MAGNASTOR[supreg] System AGENCY: Nuclear... proposing to amend its spent fuel storage regulations by revising the NAC International, Inc., Modular Advanced Generation Nuclear All-purpose Storage (MAGNASTOR[supreg]) Cask System listing within the ``List...

  3. Developing models of how cognitive improvements change functioning: Mediation, moderation and moderated mediation

    Science.gov (United States)

    Wykes, Til; Reeder, Clare; Huddy, Vyv; Taylor, Rumina; Wood, Helen; Ghirasim, Natalia; Kontis, Dimitrios; Landau, Sabine

    2012-01-01

    Background Cognitive remediation (CRT) affects functioning but the extent and type of cognitive improvements necessary are unknown. Aim To develop and test models of how cognitive improvement transfers to work behaviour using the data from a current service. Method Participants (N49) with a support worker and a paid or voluntary job were offered CRT in a Phase 2 single group design with three assessments: baseline, post therapy and follow-up. Working memory, cognitive flexibility, planning and work outcomes were assessed. Results Three models were tested (mediation — cognitive improvements drive functioning improvement; moderation — post treatment cognitive level affects the impact of CRT on functioning; moderated mediation — cognition drives functioning improvements only after a certain level is achieved). There was evidence of mediation (planning improvement associated with improved work quality). There was no evidence that cognitive flexibility (total Wisconsin Card Sorting Test errors) and working memory (Wechsler Adult Intelligence Scale III digit span) mediated work functioning despite significant effects. There was some evidence of moderated mediation for planning improvement if participants had poorer memory and/or made fewer WCST errors. The total CRT effect on work quality was d = 0.55, but the indirect (planning-mediated CRT effect) was d = 0.082 Conclusion Planning improvements led to better work quality but only accounted for a small proportion of the total effect on work outcome. Other specific and non-specific effects of CRT and the work programme are likely to account for some of the remaining effect. This is the first time complex models have been tested and future Phase 3 studies need to further test mediation and moderated mediation models. PMID:22503640

  4. 18F-FDG PET-CT after Neoadjuvant Chemoradiotherapy in Esophageal Cancer Patients to Optimize Surgical Decision Making.

    Directory of Open Access Journals (Sweden)

    Maarten C J Anderegg

    Full Text Available Prognosis of esophageal cancer patients can be significantly improved by neoadjuvant chemoradiotherapy (nCRT. Given the aggressive nature of esophageal tumors, it is conceivable that in a significant portion of patients treated with nCRT, dissemination already becomes manifest during the period of nCRT. The aim of this retrospective study was to determine the value and diagnostic accuracy of PET-CT after neoadjuvant chemoradiotherapy to identify patients with metastases preoperatively in order to prevent non-curative surgery.From January 2011 until February 2013 esophageal cancer patients deemed eligible for a curative approach with nCRT and surgical resection underwent a PET-CT after completion of nCRT. If abnormalities on PET-CT were suspected metastases, histological proof was acquired. A clinical decision model was designed to assess the cost-effectiveness of this diagnostic strategy.156 patients underwent a PET-CT after nCRT. In 31 patients (19.9% PET-CT showed abnormalities suspicious for dissemination, resulting in 17 cases of proven metastases (10.9%. Of the patients without proven metastases 133 patients were operated. In 6 of these 133 cases distant metastases were detected intraoperatively, corresponding to 4.5% false-negative results. The standard introduction of a post-neoadjuvant therapy PET-CT led to a reduction of overall health care costs per patient compared to a scenario without restaging with PET-CT ($34,088 vs. $36,490.In 10.9% of esophageal cancer patients distant metastases were detected by standard PET-CT after neoadjuvant chemoradiotherapy. To avoid non-curative resections we advocate post-neoadjuvant therapy PET-CT as a cost-effective step in the standard work-up of candidates for surgery.

  5. 18F-FDG PET-CT after Neoadjuvant Chemoradiotherapy in Esophageal Cancer Patients to Optimize Surgical Decision Making

    Science.gov (United States)

    Anderegg, Maarten C. J.; de Groof, Elisabeth J.; Gisbertz, Suzanne S.; Bennink, Roel J.; Lagarde, Sjoerd M.; Klinkenbijl, Jean H. G.; Dijkgraaf, Marcel G. W.; Bergman, Jacques J. G. H. M.; Hulshof, Maarten C. C. M.; van Laarhoven, Hanneke W. M.; van Berge Henegouwen, Mark I.

    2015-01-01

    Background Prognosis of esophageal cancer patients can be significantly improved by neoadjuvant chemoradiotherapy (nCRT). Given the aggressive nature of esophageal tumors, it is conceivable that in a significant portion of patients treated with nCRT, dissemination already becomes manifest during the period of nCRT. The aim of this retrospective study was to determine the value and diagnostic accuracy of PET-CT after neoadjuvant chemoradiotherapy to identify patients with metastases preoperatively in order to prevent non-curative surgery. Methods From January 2011 until February 2013 esophageal cancer patients deemed eligible for a curative approach with nCRT and surgical resection underwent a PET-CT after completion of nCRT. If abnormalities on PET-CT were suspected metastases, histological proof was acquired. A clinical decision model was designed to assess the cost-effectiveness of this diagnostic strategy. Results 156 patients underwent a PET-CT after nCRT. In 31 patients (19.9%) PET-CT showed abnormalities suspicious for dissemination, resulting in 17 cases of proven metastases (10.9%). Of the patients without proven metastases 133 patients were operated. In 6 of these 133 cases distant metastases were detected intraoperatively, corresponding to 4.5% false-negative results. The standard introduction of a post-neoadjuvant therapy PET-CT led to a reduction of overall health care costs per patient compared to a scenario without restaging with PET-CT ($34,088 vs. $36,490). Conclusion In 10.9% of esophageal cancer patients distant metastases were detected by standard PET-CT after neoadjuvant chemoradiotherapy. To avoid non-curative resections we advocate post-neoadjuvant therapy PET-CT as a cost-effective step in the standard work-up of candidates for surgery. PMID:26529313

  6. Cloning and characterization of genes involved in nostoxanthin biosynthesis of Sphingomonas elodea ATCC 31461.

    Directory of Open Access Journals (Sweden)

    Liang Zhu

    Full Text Available Most Sphingomonas species synthesize the yellow carotenoid nostoxanthin. However, the carotenoid biosynthetic pathway of these species remains unclear. In this study, we cloned and characterized a carotenoid biosynthesis gene cluster containing four carotenogenic genes (crtG, crtY, crtI and crtB and a β-carotene hydroxylase gene (crtZ located outside the cluster, from the gellan-gum producing bacterium Sphingomonas elodea ATCC 31461. Each of these genes was inactivated, and the biochemical function of each gene was confirmed based on chromatographic and spectroscopic analysis of the intermediates accumulated in the knockout mutants. Moreover, the crtG gene encoding the 2,2'-β-hydroxylase and the crtZ gene encoding the β-carotene hydroxylase, both responsible for hydroxylation of β-carotene, were confirmed by complementation studies using Escherichia coli producing different carotenoids. Expression of crtG in zeaxanthin and β-carotene accumulating E. coli cells resulted in the formation of nostoxanthin and 2,2'-dihydroxy-β-carotene, respectively. Based on these results, a biochemical pathway for synthesis of nostoxanthin in S. elodea ATCC 31461 is proposed.

  7. Cloning and characterization of genes involved in nostoxanthin biosynthesis of Sphingomonas elodea ATCC 31461.

    Science.gov (United States)

    Zhu, Liang; Wu, Xuechang; Li, Ou; Qian, Chaodong; Gao, Haichun

    2012-01-01

    Most Sphingomonas species synthesize the yellow carotenoid nostoxanthin. However, the carotenoid biosynthetic pathway of these species remains unclear. In this study, we cloned and characterized a carotenoid biosynthesis gene cluster containing four carotenogenic genes (crtG, crtY, crtI and crtB) and a β-carotene hydroxylase gene (crtZ) located outside the cluster, from the gellan-gum producing bacterium Sphingomonas elodea ATCC 31461. Each of these genes was inactivated, and the biochemical function of each gene was confirmed based on chromatographic and spectroscopic analysis of the intermediates accumulated in the knockout mutants. Moreover, the crtG gene encoding the 2,2'-β-hydroxylase and the crtZ gene encoding the β-carotene hydroxylase, both responsible for hydroxylation of β-carotene, were confirmed by complementation studies using Escherichia coli producing different carotenoids. Expression of crtG in zeaxanthin and β-carotene accumulating E. coli cells resulted in the formation of nostoxanthin and 2,2'-dihydroxy-β-carotene, respectively. Based on these results, a biochemical pathway for synthesis of nostoxanthin in S. elodea ATCC 31461 is proposed.

  8. An analysis of the proposed Airline Competition Enhancement Act

    OpenAIRE

    Smith, Janice S.

    1990-01-01

    Approved for public release, distribution is unlimited This analysis examines problem issues in the passenger airline industry and determines how the proposed Airline Competition Enhancement Act would impact these issues. A summarization of the history of airline deregulation is followed by an assessment of the factors that are contributing to the call for re-regulation. From this assessment, recommendations for changes to the proposed Airline Competition Enhancement Act are made. Lieut...

  9. 76 FR 61360 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

    Science.gov (United States)

    2011-10-04

    ... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential... Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative... Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork...

  10. Acute effects of exercise and active video games on adults' reaction time and perceived exertion.

    Science.gov (United States)

    Guzmán, José F; López-García, Jesús

    2016-11-01

    The purpose of the present study was to examine the acute effects of resting, aerobic exercise practised alone, and aerobic exercise with active video games (AVG), on complex reaction time (CRT) and the post-exercise acute rate of perceived exertion (RPE) in young healthy adults. The experimental group was composed of 92 healthy young adults, 78 males and 13 females (age M = 21.9 ± 2.7 years) who completed two sessions, A and B. In session A, participants rode 30 min on an ergometer, while in session B they exercised for 30 min on an ergometer while playing an AVG on a Wii. The control group was composed of 30 young adults, 26 males and 4 females (age M = 21.4 ± 2.9 years) who rested for 30 min. In each session, a CRT task was performed before and after exercising or resting, and post-exercise global RPE was noted. Repeated measures general linear model (GLM) and Wilcoxon tests were performed. (1) Both aerobic exercise alone and aerobic exercise combined with AVG improved CRT, while resting did not; (2) aerobic exercise combined with AVG did not improve CRT more than aerobic exercise only; and (3) RPE was lower after aerobic exercise combined with AVG compared with aerobic exercise only. In young adults, exercise produces acute benefits on CRT, and practising exercise with AVG helps to decrease RPE.

  11. Effect of study design on the reported effect of cardiac resynchronization therapy (CRT) on quantitative physiological measures: stratified meta-analysis in narrow-QRS heart failure and implications for planning future studies.

    Science.gov (United States)

    Jabbour, Richard J; Shun-Shin, Matthew J; Finegold, Judith A; Afzal Sohaib, S M; Cook, Christopher; Nijjer, Sukhjinder S; Whinnett, Zachary I; Manisty, Charlotte H; Brugada, Josep; Francis, Darrel P

    2015-01-06

    Biventricular pacing (CRT) shows clear benefits in heart failure with wide QRS, but results in narrow QRS have appeared conflicting. We tested the hypothesis that study design might have influenced findings. We identified all reports of CRT-P/D therapy in subjects with narrow QRS reporting effects on continuous physiological variables. Twelve studies (2074 patients) met these criteria. Studies were stratified by presence of bias-resistance steps: the presence of a randomized control arm over a single arm, and blinded outcome measurement. Change in each endpoint was quantified using a standardized effect size (Cohen's d). We conducted separate meta-analyses for each variable in turn, stratified by trial quality. In non-randomized, non-blinded studies, the majority of variables (10 of 12, 83%) showed significant improvement, ranging from a standardized mean effect size of +1.57 (95%CI +0.43 to +2.7) for ejection fraction to +2.87 (+1.78 to +3.95) for NYHA class. In the randomized, non-blinded study, only 3 out of 6 variables (50%) showed improvement. For the randomized blinded studies, 0 out of 9 variables (0%) showed benefit, ranging from -0.04 (-0.31 to +0.22) for ejection fraction to -0.1 (-0.73 to +0.53) for 6-minute walk test. Differences in degrees of resistance to bias, rather than choice of endpoint, explain the variation between studies of CRT in narrow-QRS heart failure addressing physiological variables. When bias-resistance features are implemented, it becomes clear that these patients do not improve in any tested physiological variable. Guidance from studies without careful planning to resist bias may be far less useful than commonly perceived. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  12. Design and implementation of a rotational radiotherapy technique for breast cancer treatment and their comparison with 3-D-Crt irradiation technique; Diseno e implementacion de una tecnica de radioterapia rotacional para tratamiento de cancer de mama y su comparacion contra la tecnica 3D-CRT de irradiacion

    Energy Technology Data Exchange (ETDEWEB)

    Gutierrez M, J. G.; Lopez V, A.; Rivera M, T. [IPN, Centro de Investigacion en Ciencia Aplicada y Tecnologia Avanzada, Av. Legaria 694, Col. Irrigacion, 11500 Mexico D. F. (Mexico); Velazquez T, J. J.; Adame G, C. S. [Centro Medico Nacional Siglo XXI, Hospital de Oncologia, Departamento de Fisica Medica, Av. Cuauhtemoc No. 330, Col. Doctores, 06720 Mexico D. F. (Mexico); Rubio N, O.; Chagoya G, A.; Hernandez G, J. C., E-mail: jggm25@yahoo.com.mx [Centro Medico Nacional Siglo XXI, Hospital de Oncologia, Departamento de Radioterapia, Av. Cuauhtemoc No. 330, Col. Doctores, 06720 Mexico D. F. (Mexico)

    2015-10-15

    Breast cancer is one of oncological diseases worldwide, as well in Mexico, which causes even more deaths than cervical cancer; this condition is the second death cause in women aged 30-54 years and threatens all socio-economic groups. The treatment is highly dependent on the stage which is detected and based on protocols that include a combination of surgery, chemotherapy and radiotherapy. This paper studies the main irradiation technique for patients with mastectomy, breast full cycle (irradiation of the chest well and supraclavicular nodes) in their mode Three Dimensional - Conformal Radiation Therapy (3-D-Crt), and compared with the Volumetric Modulated Arc Therapy (VMAT) technique proposed in this paper. In both techniques the prescription was 50 Gy divided into 25 fractions. The techniques were applied in three female patients (being an initial study) with disease of the left side, the target volume and organs at risk were delineated by the medical treating radiation oncologist, the planning system used was Eclipse version 10; for quantitative comparison of both plans indexes of homogeneity were used, con formality, the target volume coverage and normal tissue, sub factors and overdosing, the conformation number and coverage quality. They were evaluated and compared the media, maximum and minimum dose of the organs at risk, based on the fact that the coverage of the target volume, dose gradient and dose at risk organs are acceptable (prescription dose greater that 90% coverage, gradient less that 20% and organs at risk in accordance with the Quantec limitations for both versions). (Author)

  13. Results and DVH analysis of late rectal bleeding in patients treated with 3D-CRT or IMRT for localized prostate cancer

    International Nuclear Information System (INIS)

    Someya, Masanori; Hori, Masakazu; Tateoka, Kunihiko; Nakata, Kensei; Saito, Masato; Hirokawa, Naoki; Sakata, Koh-ichi; Takagi, Masaru; Hareyama, Masato

    2015-01-01

    In patients undergoing radiotherapy for localized prostate cancer, dose-volume histograms and clinical variables were examined to search for correlations between radiation treatment planning parameters and late rectal bleeding. We analyzed 129 patients with localized prostate cancer who were managed from 2002 to 2010 at our institution. They were treated with 3D conformal radiation therapy (3D-CRT, 70 Gy/35 fractions, 55 patients) or intensity-modulated radiation therapy (IMRT, 76 Gy/38 fractions, 74 patients). All radiation treatment plans were retrospectively reconstructed, dose-volume histograms of the rectum were generated, and the doses delivered to the rectum were calculated. Time to rectal bleeding ranged from 9 - 53 months, with a median of 18.7 months. Of the 129 patients, 33 patients had Grade 1 bleeding and were treated with steroid suppositories, while 25 patients with Grade 2 bleeding received argon plasma laser coagulation therapy (APC). Three patients with Grade 3 bleeding required both APC and blood transfusion. The 5-year incidence rate of Grade 2 or 3 rectal bleeding was 21.8% for the 3D-CRT group and 21.6% for the IMRT group. Univariate analysis showed significant differences in the average values from V65 to V10 between Grades 0 - 1 and Grades 2 - 3. Multivariate analysis demonstrated that patients with V65 ≥ 17% had a significantly increased risk (P = 0.032) of Grade 2 or 3 rectal bleeding. Of the 28 patients of Grade 2 or 3 rectal bleeding, 17 patients (60.7%) were cured by a single session of APC, while the other 11 patients required two sessions. Thus, none of the patients had any further rectal bleeding after the second APC session. (author)

  14. Quality assurance of approved out of programme psychiatry training and research over the past 5 years

    Science.gov (United States)

    Osman-Hicks, Victoria; Graham, Hannah; Leadbetter, Peter; Brittlebank, Andrew

    2015-01-01

    Aims and method This paper intends to analyse the number of applications, trainee demographic and approval rate of those applying for out of programme training (OOPT) or out of programme research (OOPR) between January 2008 and April 2013 using the committee’s anonymised database. We also describe the process of application and approval by the Quality Assurance Committee. Results There were 90 applications, including 10 resubmissions during the 64-month period. Most applicants (77%) were higher trainees; 53% of applicants were from the London deanery; 60% of applications were for research posts and higher degrees (OOPR). Overall, 64% were approved by the committee: 70% for OOPRs and 53% for OOPTs. Clinical implications This paper shows with transparency the breakdown of applications to the Quality Assurance Committee. Around two-thirds of applications to the committee are supported (64%). Relatively few psychiatry trainees (2.5%) have applied for an OOPT or an OOPR over the past 5 years. PMID:26191450

  15. 75 FR 47629 - Agency Information Collection Activities; Proposals, Submissions, and Approvals

    Science.gov (United States)

    2010-08-06

    ... supporting documentation; including, among other things, a description of the likely respondents, proposed... appropriate, OWCP must receive certain data elements, including the signature of the physician for medical...

  16. 77 FR 16795 - Approval and Promulgation of Implementation Plans and Operating Permits Program; Commonwealth of...

    Science.gov (United States)

    2012-03-22

    .... SUMMARY: EPA is proposing to approve revisions to the Puerto Rico Regulations for the Control of Atmospheric Pollution, submitted to EPA by the Puerto Rico Environmental Quality Board (PREQB) on July 13...

  17. 77 FR 42497 - Information Collection(s) Being Submitted for Review and Approval to the Office of Management and...

    Science.gov (United States)

    2012-07-19

    ... officer (a post staffed 24 hours a day) in the FCC's Communications and Crisis Management Center in... Approval to the Office of Management and Budget (OMB) AGENCY: Federal Communications Commission. ACTION... comments to Nicholas A. Fraser, Office of Management and Budget (OMB), via fax at 202-395-5167 or via...

  18. The use of FDG-PET/CT and diffusion-weighted magnetic resonance imaging for response prediction before, during and after preoperative chemoradiotherapy for rectal cancer

    International Nuclear Information System (INIS)

    Lambrecht, Maarten; Roels, Sarah; Haustermans, Karin; Deroose, Christophe; Vandecaveye, Vincent; Keyzer, Frederik de; Penninckx, Freddy; Sagaert, Xavier; Cutsem, Eric van

    2010-01-01

    Purpose. To investigate the use of FDG-PET/CT before, during and after chemoradiotherapy (CRT) and diffusion-weighted magnetic resonance imaging (DW-MRI) before CRT for the prediction of pathological response (pCR) in rectal cancer patients. Material and methods. Twenty-two rectal cancer patients treated with long course CRT were included. An FDG-PET/CT was performed prior to the start of CRT, after 10 to 12 fractions of CRT and five weeks after the end of CRT. The tumor was delineated using a gradient based delineation method and the maximal standardized uptake values (SUV max ) were calculated. A DW-MRI was performed before start of CRT. Mean apparent diffusion coefficients (ADC) were determined. The ΔSUV max during and after CRT and the initial ADC values were correlated to the histopathological findings after total mesorectal excision (TME). Results. ΔSUV max during and after CRT significantly correlated with the pathological response to treatment (during CRT: ΔSUV max = 59% ± 12% for pCR vs. 25% ± 27% if no pCR, p=0.0036; post-CRT: 90% ± 11 for pCR vs. 63% ± 22 if no pCR p=0.013). ROC curve analysis revealed an optimal threshold for ΔSUV max of 40% during CRT and 76% after CRT. The initial ADC value was also significantly correlated with pCR (0.94 ± 0.12 x 10-3 mm 2 /s for pCR vs. 1.2 ± 0.24 x 10-3 mm 2 /s, p=0.002) and ROC curve analysis revealed an optimal threshold of 1.06 x 10-3 mm 2 /s. Combining the provided ΔSUV max thresholds during and after CRT increased specificity of the prediction (sensitivity 100% and specificity 94%). The combination of the thresholds for the initial ADC value and the ΔSUV max during CRT increased specificity of the prediction to a similar level (sensitivity of 100% and specificity of 94%). Conclusions. The combination of the different time points and the different imaging modalities increased the specificity of the response assessment both during and after CRT.

  19. Benefit analysis of proposed information systems

    OpenAIRE

    Besore, Mark H.

    1991-01-01

    Approved for public release; distribution is unlimited This thesis reviewed two different approaches to benefit analysis, benefit comparison and user satisfaction, that could be applied to the evaluation of proposed information systems which are under consideration for acquisition by the federal government. Currently the General Services Administration only recommends that present value analysis methods be used in the analysis of alternatives even though the GSA specifies...

  20. Benefits of group cognitive remediation therapy in anorexia nervosa: case series.

    Science.gov (United States)

    Tchanturia, Kate; Larsson, Emma; Brown, Amy

    2016-03-01

    Cognitive remediation therapy (CRT) is a treatment targeting cognitive difficulties in psychiatric disorders. CRT has been used with patients with severe anorexia nervosa (AN) in individual and group formats. Research of group CRT in AN is limited. Evaluation of a series of CRT groups delivered in inpatient and intensive daycare services was performed. Participants' self-reported cognitive flexibility and central coherence, as well as motivation to change were assessed pre- and post-group. Additionally, patients' evaluative feedback was collected after completion of the group. There was a significant improvement in the patients' self-reported cognitive flexibility and bigger picture thinking, as well as in their self-efficacy to change. The feedback questionnaires highlighted that patients found the sessions useful and reported confidence in using some of the skills and strategies they learnt in the group. In line with evidence from small-scale reports, this larger scale case series study indicates that group CRT leads to increased flexibility and bigger picture thinking, as well as improved confidence in the ability to change for participants. CRT in a group format seems to be a practical and helpful intervention for patients with AN in intensive treatment programmes.

  1. 75 FR 12090 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality...

    Science.gov (United States)

    2010-03-12

    ... proposes to approve a request from the State of Indiana to redesignate Lake and Porter Counties to... (SIP), the State's plan for maintaining the eight-hour ozone standard through 2020 in Lake and Porter... inventories for Lake and Porter Counties as a revision of the Indiana SIP. Finally, EPA proposes to find...

  2. 75 FR 8983 - Notice of Proposed Information Collection for Public Comment: Housing Counseling Outcomes Study

    Science.gov (United States)

    2010-02-26

    ... outcomes realized by clients of HUD-approved counseling agencies seeking assistance to either purchase a home (pre-purchase clients) or to resolve or prevent mortgage delinquency (post-purchase clients... about their counseling experience and their current housing situation. The purpose of this survey is to...

  3. 76 FR 71996 - Notice of Submission of Proposed Information Collection to OMB; Capacity Building for Sustainable...

    Science.gov (United States)

    2011-11-21

    ... Proposed Information Collection to OMB; Capacity Building for Sustainable Communities Program AGENCY... proposal. The Capacity Building for Sustainable Communities Program (Program), through a Notice of Funding...: Title of Proposal: Capacity Building for Sustainable Communities Program OMB Approval Number: 2501-0026...

  4. 76 FR 12072 - Guidance for Agency Information Collection Activities: Proposed Collection; Comment Request...

    Science.gov (United States)

    2011-03-04

    ... requirements or power calculations that justify the proposed sample size, the expected response rate, methods... Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative... Qualitative Feedback on Agency Service Delivery'' for approval under the Paperwork Reduction Act (PRA) (44 U.S...

  5. Monitoring readiness of safety relevant devices in nuclear power plants by means of CRT-colour displays

    International Nuclear Information System (INIS)

    Haubert, R.; Stokke, R.

    1980-01-01

    The development of an information system for monitoring readiness of safety relevant devices is encouraged by the requirements of KTA-rule 3501 (DIN 25434), which states in section 4.9.1.1. 'A display shall be provided for giving a survey of the condition of the components of the reactor protection system and the active engineered safeguards including their energy and auxiliary media supplies'. In the first stage of the development which was reported at the Enlarged Halden Programme Group Meeting in Loen, Norway, 5th-9th June, 1978, only the components of parts of a BWR-protection system were considered and no display was provided. This paper outlines the next step in the development which comprises implementation of the active engineered safeguards into the system and development of a display system based on a colour CRT-screen. A prototype of this computer-based system for monitoring of protection systems has been established, and it is planned to demonstrate this prototype system using the computer equipment at GRS, Garching (orig./HP)

  6. Design and implementation of a rotational radiotherapy technique for breast cancer treatment and their comparison with 3-D-Crt irradiation technique

    International Nuclear Information System (INIS)

    Gutierrez M, J. G.; Lopez V, A.; Rivera M, T.; Velazquez T, J. J.; Adame G, C. S.; Rubio N, O.; Chagoya G, A.; Hernandez G, J. C.

    2015-10-01

    Breast cancer is one of oncological diseases worldwide, as well in Mexico, which causes even more deaths than cervical cancer; this condition is the second death cause in women aged 30-54 years and threatens all socio-economic groups. The treatment is highly dependent on the stage which is detected and based on protocols that include a combination of surgery, chemotherapy and radiotherapy. This paper studies the main irradiation technique for patients with mastectomy, breast full cycle (irradiation of the chest well and supraclavicular nodes) in their mode Three Dimensional - Conformal Radiation Therapy (3-D-Crt), and compared with the Volumetric Modulated Arc Therapy (VMAT) technique proposed in this paper. In both techniques the prescription was 50 Gy divided into 25 fractions. The techniques were applied in three female patients (being an initial study) with disease of the left side, the target volume and organs at risk were delineated by the medical treating radiation oncologist, the planning system used was Eclipse version 10; for quantitative comparison of both plans indexes of homogeneity were used, con formality, the target volume coverage and normal tissue, sub factors and overdosing, the conformation number and coverage quality. They were evaluated and compared the media, maximum and minimum dose of the organs at risk, based on the fact that the coverage of the target volume, dose gradient and dose at risk organs are acceptable (prescription dose greater that 90% coverage, gradient less that 20% and organs at risk in accordance with the Quantec limitations for both versions). (Author)

  7. 78 FR 4124 - Approval of Subzone Status, Coamo Property & Investments, LLC, Coamo, PR

    Science.gov (United States)

    2013-01-18

    ... DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-107-2012] Approval of Subzone Status, Coamo Property & Investments, LLC, Coamo, PR On October 9, 2012, the Executive Secretary of the Foreign-Trade... the proposed operator, Coamo Property & Investments, LLC, in Coamo, Puerto Rico. The application was...

  8. 75 FR 56946 - Medicaid Program; Review and Approval Process for Section 1115 Demonstrations

    Science.gov (United States)

    2010-09-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 431 [CMS-2325-P] RIN 0938-AQ46 Medicaid Program; Review and Approval Process for Section 1115 Demonstrations AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This...

  9. 75 FR 5157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-02-01

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Consolidated FINRA Rulebook January 25, 2010. On December 2, 2009, the Financial Industry Regulatory Authority... later in the rulebook consolidation process. It is therefore ordered, pursuant to Section 19(b)(2) of...

  10. Impact of the diagnostic changes to post-traumatic stress disorder for DSM-5 and the proposed changes to ICD-11.

    Science.gov (United States)

    O'Donnell, Meaghan L; Alkemade, Nathan; Nickerson, Angela; Creamer, Mark; McFarlane, Alexander C; Silove, Derrick; Bryant, Richard A; Forbes, David

    2014-09-01

    There have been changes to the criteria for diagnosing post-traumatic stress disorder (PTSD) in DSM-5 and changes are proposed for ICD-11. To investigate the impact of the changes to diagnostic criteria for PTSD in DSM-5 and the proposed changes in ICD-11 using a large multisite trauma-exposed sample and structured clinical interviews. Randomly selected injury patients admitted to four hospitals were assessed 72 months post trauma (n = 510). Structured clinical interviews for PTSD and major depressive episode, as well as self-report measures of disability and quality of life were administered. Current prevalence of PTSD under DSM-5 scoring was not significantly different from DSM-IV (6.7% v. 5.9%, z = 0.53, P = 0.59). However, the ICD-11 prevalence was significantly lower than ICD-10 (3.3% v. 9.0%, z = -3.8, PDSM-5 than ICD-11 (6.7% v. 3.3%, z = 2.5, P = 0.01). Using ICD-11 tended to show lower rates of comorbidity with depression and a slightly lower association with disability. The diagnostic systems performed in different ways in terms of current prevalence rates and levels of comorbidity with depression, but on other broad key indicators they were relatively similar. There was overlap between those with PTSD diagnosed by ICD-11 and DSM-5 but a substantial portion met one but not the other set of criteria. This represents a challenge for research because the phenotype that is studied may be markedly different according to the diagnostic system used. Royal College of Psychiatrists.

  11. The family name Solimonadaceae Losey et al. 2013 is illegitimate, proposals to create the names 'Sinobacter soli' comb. nov. and 'Sinobacter variicoloris' contravene the Code, the family name Xanthomonadaceae Saddler and Bradbury 2005 and the order name Xanthomonadales Saddler and Bradbury 2005 are illegitimate and notes on the application of the family names Solibacteraceae Zhou et al. 2008, Nevskiaceae Henrici and Johnson 1935 (Approved Lists 1980) and Lysobacteraceae Christensen and Cook 1978 (Approved Lists 1980) and order name Lysobacteriales Christensen and Cook 1978 (Approved Lists 1980) with respect to the classification of the corresponding type genera Solibacter Zhou et al. 2008, Nevskia Famintzin 1892 (Approved Lists 1980) and Lysobacter Christensen and Cook 1978 (Approved Lists 1980) and importance of accurately expressing the link between a taxonomic name, its authors and the corresponding description/circumscription/emendation.

    Science.gov (United States)

    Tindall, B J

    2014-01-01

    In a recent publication the name Solimonadaceae Losey et al. 2013 has been proposed as a replacement name for the family name Sinobacteraceae Zhou et al. 2008. This course of action contravenes the current Code governing the nomenclature of prokaryotes, making Solimonadaceae Losey et al. 2013 an illegitimate name that neither has claim to priority nor can be used as a correct name. Closer examination of publications dealing with the taxonomy of members of the genera Solimonas and Sinobacter and the placement of these taxa at the rank of family and order reveal problems associated with the application of the family names Sinobacteraceae Zhou et al. 2008, Nevskiaceae Henrici and Johnson 1935 (Approved Lists 1980) and Lysobacteraceae Christensen and Cook 1978 (Approved Lists 1980) and the order names Lysobacterales Christensen and Cook 1978 (Approved Lists 1980) and Xanthomonadales Saddler and Bradbury 2005.

  12. Early post-treatment pseudo-progression amongst glioblastoma multiforme patients treated with radiotherapy and temozolomide: a retrospective analysis

    International Nuclear Information System (INIS)

    Gunjur, Ashray; Lau, Eddie; Taouk, Yamna; Ryan, Gail

    2011-01-01

    To evaluate the incidence and impact of early post-chemoradiation (cRT) 'pseudoprogression' (PsPD) amongst glioblastoma multiforme (GBM) patients treated with the current standard of care – 60 Gy conformal radiotherapy with concurrent low-dose temozolomide, followed by six cycles of high-dose temozolomide (the 'Stupp protocol'). Clinical notes and radiology reports for GBM patients treated as per the Stupp protocol were reviewed. PsPD was defined as apparent radiological progression on the first post-cRT scan, with further imaging within 3 months being stable or improving, while true early progression (ePD) was confirmed by continued progression in the subsequent 3 months following the first post-cRT scan. Of the 68 patients evaluated, 14 (21%) and 27 (40%) experienced PsPD and ePD, respectively; 3/14 (21%) patients experiencing PsPD and 14/27(52%), ePD were symptomatic for progression on first post-cRT follow-up (P = 0.096 for difference). Median survival for patients with ePD, PsPD and neither were 10.4, 27.4 and 13.0 months, respectively (P = 0.003 for ePD vs. PsPD, P = 0.19 for neither vs. PsPD groups). These data confirm a significant incidence of PsPD in post-cRT GBM patients, associated with improved median survival compared with those with neither ePD nor PsPD (not statistically significant). It appears likely that PsPD actually represents tumour response, conflicting with the traditional notion that increase in lesion size on contrast-enhanced imaging represents disease progression. Early post-cRT imaging should thus be interpreted with caution. Accompanying clinical symptoms are more commonly associated with ePD, but do not reliably distinguish PsPD from ePD.

  13. Key Generation for Fast Inversion of the Paillier Encryption Function

    Science.gov (United States)

    Hirano, Takato; Tanaka, Keisuke

    We study fast inversion of the Paillier encryption function. Especially, we focus only on key generation, and do not modify the Paillier encryption function. We propose three key generation algorithms based on the speeding-up techniques for the RSA encryption function. By using our algorithms, the size of the private CRT exponent is half of that of Paillier-CRT. The first algorithm employs the extended Euclidean algorithm. The second algorithm employs factoring algorithms, and can construct the private CRT exponent with low Hamming weight. The third algorithm is a variant of the second one, and has some advantage such as compression of the private CRT exponent and no requirement for factoring algorithms. We also propose the settings of the parameters for these algorithms and analyze the security of the Paillier encryption function by these algorithms against known attacks. Finally, we give experimental results of our algorithms.

  14. 39 CFR 241.3 - Discontinuance of post offices.

    Science.gov (United States)

    2010-07-01

    ... CLASSIFICATION, AND DISCONTINUANCE § 241.3 Discontinuance of post offices. (a) Introduction—(1) Coverage. This... justify in sufficient detail to Postal Service management and affected customers the proposed service... inspection during normal business hours at each post office where the Final Determination is posted for 30...

  15. 75 FR 26892 - Approval and Promulgation of Implementation Plans; Texas; Excess Emissions During Startup...

    Science.gov (United States)

    2010-05-13

    ... corrective action to avoid a malfunction, then the event is considered an unplanned maintenance activity or... Promulgation of Implementation Plans; Texas; Excess Emissions During Startup, Shutdown, Maintenance, and... Emissions Events and Scheduled Maintenance, Startup, and Shutdown Activities. This action proposes approval...

  16. 75 FR 41254 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-07-15

    ... registered capacity, may work in other investment-related industries, such as financial planning, or may seek...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule..., 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and...

  17. 75 FR 27286 - Notice of Request for Revision of a Currently Approved Information Collection

    Science.gov (United States)

    2010-05-14

    ... development and job creation projects such as business start-up costs, business expansion, community... DEPARTMENT OF AGRICULTURE Rural Business-Cooperative Service Notice of Request for Revision of a Currently Approved Information Collection AGENCY: Rural Business-Cooperative Service, USDA. ACTION: Proposed...

  18. 77 FR 75933 - Approval and Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year...

    Science.gov (United States)

    2012-12-26

    ... email. The www.regulations.gov Web site is an ``anonymous access'' system, which means EPA will not know... Promulgation of Air Quality Implementation Plans; West Virginia; The 2002 Base Year Emissions Inventory for the...: Proposed rule. SUMMARY: EPA is proposing to approve the 2002 base year emissions inventory portion of the...

  19. 76 FR 13423 - Notice of Submission of Proposed Information Collection to OMB; Contractor's Requisition-Project...

    Science.gov (United States)

    2011-03-11

    ... Proposed Information Collection to OMB; Contractor's Requisition--Project Mortgages AGENCY: Office of the.... Contractor's monthly application for distribution of insured mortgage proceeds for construction costs... Following Information Title of Proposal: Contractor's Requisition--Project Mortgages. OMB Approval Number...

  20. 75 FR 19645 - Enterprise Texas Pipeline LLC; Notice of Petition for Rate Approval

    Science.gov (United States)

    2010-04-15

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR10-14-000] Enterprise..., 2010, Enterprise Texas Pipeline LLC (Enterprise Texas) filed a petition for rate approval pursuant to section 284.123(b)(2) of the Commission's regulations. Enterprise Texas proposes rates of $0.6090 per...

  1. 76 FR 65507 - Notice of Petition for Rate Approval; Eagle Ford Midstream, LP

    Science.gov (United States)

    2011-10-21

    ... Petition for Rate Approval; Eagle Ford Midstream, LP Take notice that on October 11, 2011, (Eagle Ford..., and its initial baseline Statement of Operating Conditions. Eagle Ford states that it is an existing..., currently providing intrastate services to its customers. Eagle Ford proposed rates for Section 311...

  2. Ear Acupuncture for Post-Operative Pain Associated with Ambulatory Arthroscopic Knee Surgery: A Randomized Controlled Trial

    Science.gov (United States)

    2014-01-14

    E7(/(3+21(180%(5 ,QFOXGHDUHDFRGH 14 Jan 2014 Final Report Ear acupuncture for post-operative pain associated with ambulatory arthroscopic...DISTRIBUTION A. Approved for public release: distribution unlimited. The purpose of this study is to compare ear acupuncture plus standard therapy versus...3298 Ear Acupuncture for Post-operative Pa111 Assoc1ated With Ambulatory Arthroscopic Knee Surgery A Randomized Controlled Trial ’• V ’’ ’-’ I

  3. 7 CFR 3406.18 - Content of a research proposal.

    Science.gov (United States)

    2010-01-01

    ... for publications. Identify target audiences and explain methods of communication. (iv) Partnerships... complete understanding of a proposal or to illustrate the integrity of the design or a main thesis of the... approve the research plan before CSREES will release grant funds. (2) Protection of human subjects...

  4. 77 FR 40051 - Proposed Agency Information Collection Activities; Comment Request

    Science.gov (United States)

    2012-07-06

    ... quarterly on the bank holding company's Consolidated Financial Statements for Bank Holding Companies (FR Y.... Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of..., including the proposed reporting form and instructions, supporting statement, and other documentation will...

  5. A viewpoint on the approval context of strategic environmental assessments

    International Nuclear Information System (INIS)

    Kontić, Branko; Kontić, Davor

    2012-01-01

    A reflection on the last report from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application and effectiveness of the Directive on Strategic Environmental Assessment (SEA) is provided. It covers the inadequacies of the approval/permitting context of SEA, which appears to be increasingly applied by a significant number of Member States in recent years. A viewpoint is provided on the main deficiencies of such praxis. As a practical defence of the planning context of SEA, the authors propose that the EC should consider a clear recommendation to Member States to cease performing SEA in the approval/permitting context until proper amendments to the SEA Directive are made and implemented. - Highlights: ► Administrative and permitting context of SEA, has ousted the primary environmental impact assessment goal. ► The approval context moves from the environmental protection to the area of political power and economy. ► SEA and EIA are misused. ► Environmental evaluations should be used for improving the projects/plans/programmes and not for permitting them.

  6. 75 FR 45145 - Notice of Submission of Proposed Information Collection to OMB Final Endorsement of Credit...

    Science.gov (United States)

    2010-08-02

    ... Proposed Information Collection to OMB Final Endorsement of Credit Instrument (HUD Programs) AGENCY: Office... proposal. Information collected is used to request final endorsement by HUD of the credit instrument. The...: Title of Proposal: Final Endorsement of Credit Instrument. OMB Approval Number: 2502-0016. Form Numbers...

  7. Biosimilars approval process.

    Science.gov (United States)

    Zuñiga, Leyre; Calvo, Begoña

    2010-04-01

    For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier. Copyright 2009 Elsevier Inc. All rights reserved.

  8. Structures of parasite calreticulins provide insights into their flexibility and dual carbohydrate/peptide-binding properties.

    Science.gov (United States)

    Moreau, Christophe; Cioci, Gianluca; Iannello, Marina; Laffly, Emmanuelle; Chouquet, Anne; Ferreira, Arturo; Thielens, Nicole M; Gaboriaud, Christine

    2016-11-01

    Calreticulin (CRT) is a multifaceted protein, initially discovered as an endoplasmic reticulum (ER) chaperone protein, that is essential in calcium metabolism. Various implications in cancer, early development and immunology have been discovered more recently for CRT, as well as its role as a dominant 'eat-me' prophagocytic signal. Intriguingly, cell-surface exposure/secretion of CRT is among the infective strategies used by parasites such as Trypanosoma cruzi , Entamoeba histolytica , Taenia solium , Leishmania donovani and Schistosoma mansoni . Because of the inherent flexibility of CRTs, their analysis by X-ray crystallography requires the design of recombinant constructs suitable for crystallization, and thus only the structures of two very similar mammalian CRT lectin domains are known. With the X-ray structures of two distant parasite CRTs, insights into species structural determinants that might be harnessed to fight against the parasites without affecting the functions of the host CRT are now provided. Moreover, although the hypothesis that CRT can exhibit both open and closed conformations has been proposed in relation to its chaperone function, only the open conformation has so far been observed in crystal structures. The first evidence is now provided of a complex conformational transition with the junction reoriented towards P-domain closure. SAXS experiments also provided additional information about the flexibility of T. cruzi CRT in solution, thus complementing crystallographic data on the open conformation. Finally, regarding the conserved lectin-domain structure and chaperone function, evidence is provided of its dual carbohydrate/protein specificity and a new scheme is proposed to interpret such unusual substrate-binding properties. These fascinating features are fully consistent with previous experimental observations, as discussed considering the broad spectrum of CRT sequence conservations and differences.

  9. Prediction and monitoring of the response to chemoradiotherapy in oral squamous cell carcinomas using a pharmacokinetic analysis based on the dynamic contrast-enhanced MR imaging findings

    Energy Technology Data Exchange (ETDEWEB)

    Chikui, Toru; Kawazu, Toshiyuki; Yoshiura, Kazunori [Kyushu University, Department of Oral and Maxillofacial Radiology, Faculty of Dental Science, Fukuoka (Japan); Kawano, Shintaro [Kyushu University, Section of Oral and Maxillofacial Oncology, Division of Maxillofacial Diagnostic and Surgical Sciences, Faculty of Dental Science, Fukuoka (Japan); Hatakenaka, Masamitsu [Kyushu University, Department of Clinical Radiology, Graduate School of Medical Sciences, Fukuoka (Japan); Kyushu University, Radiology Center, Kyushu University Hospital, Fukuoka (Japan); Koga, Syouzou; Ohga, Masahiro [Kyushu University, Radiology Center, Kyushu University Hospital, Fukuoka (Japan); Matsuo, Yoshio; Sunami, Syunya [Kyushu University, Department of Clinical Radiology, Graduate School of Medical Sciences, Fukuoka (Japan); Sugiura, Tsuyoshi [Kyushu University, Department of Maxillofacial Surgery, Kyushu University Hospital, Fukuoka (Japan); Shioyama, Yoshiyuki [Kyushu University, Department of Heavy Particle Therapy and Radiation Oncology, Graduate School of Medical Sciences, Fukuoka (Japan); Obara, Makoto [Philips Electronics Japan, Ltd 2-13-37, Konan Minato-ku, Tokyo (Japan)

    2011-08-15

    To evaluate whether a pharmacokinetic analysis is useful for both predicting and monitoring the response to chemoradiotherapy (CRT) in oral cancer. Patients with oral squamous cell carcinoma treated with preoperative CRT and surgery were enrolled. They underwent dynamic contrast-enhanced MRI before (n = 23), and after CRT (n = 20). We estimated four parameters: arrival time of contrast medium (TA), exchange rate constant from the extracellular extravascular space (EES) to plasma (k{sub ep}), elimination of contrast medium from the central compartment (k{sub el}) and an amplitude scaling constant (AH) using the Brix model. The histological evaluation of the effects of CRT was performed according to Ohboshi and Shimosato's classification. We analysed the correlation between the parameters and the histological evaluation. The pre-CRT AH between the responders and non-responders was significantly different (P = 0.046), however, the three parameters (TA, K{sub ep}, K{sub el}) were not significantly different among the groups (P = 0.76, P = 0.60, P = 0.09). As AH decreased, the tumour response improved. The change in the AH between the pre- and post-CRT of responders was significantly higher than that of non-responders (P = 0.043). The AH, which is affected by the ratio of the EES, was an important parameter for predicting and monitoring the tumour response to CRT. (orig.)

  10. 76 FR 51075 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Granting Approval to...

    Science.gov (United States)

    2011-08-17

    ... Organizations; International Securities Exchange, LLC; Order Granting Approval to a Proposed Rule Change Relating to Appointments to Competitive Market Makers August 11, 2011. I. Introduction On June 10, 2011, the International Securities Exchange, LLC (the ``Exchange'' or the ``ISE'') filed with the Securities...

  11. 75 FR 43588 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-07-26

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule... FINRA Rule 4320 in the Consolidated FINRA Rulebook July 20, 2010. On May 21, 2010, the Financial... application by their terms. For more information about the rulebook consolidation process, see Information...

  12. 75 FR 59771 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the...

    Science.gov (United States)

    2010-09-28

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the Proposed Rule.... I. Introduction On July 27, 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k... pertinent distribution-related information from its members in a timely fashion to facilitate its Regulation...

  13. 75 FR 1437 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a...

    Science.gov (United States)

    2010-01-11

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61274; File No. SR-CBOE-2009-089] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a Proposed Rule... announce to members via Regulatory Circular any determination regarding the routing of market stock-option...

  14. 77 FR 36442 - Approval and Promulgation of Air Quality Implementation Plans; Michigan; PSD Regulations

    Science.gov (United States)

    2012-06-19

    ... pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile... 2.5 , EPA will defer action on this matter. EPA is also proposing to approve the removal of R. 336...

  15. 76 FR 2755 - Proposed Information Collection (Statement in Support of Claim for Service Connection for Post...

    Science.gov (United States)

    2011-01-14

    ... (Statement in Support of Claim for Service Connection for Post-Traumatic Stress Disorder (PTSD) and Statement in Support of Claim for Service Connection for Post-Traumatic Stress Disorder (PTSD) Secondary to... to substantiate claims for service connection post-traumatic stress disorder (PTSD). DATES: Written...

  16. Request for approval, vented container annual release fraction

    International Nuclear Information System (INIS)

    HILL, J.S.

    1999-01-01

    In accordance with the approval conditions for Modification to the Central Waste Complex (CWC) Radioactive Air Emissions Notice of Construction (NOC). dated August 24,1998, a new release fraction has been developed for submittal to the Washington State Department of Health (WDOH). The proposed annual release fraction of 2.50 E-14 is proposed for use in future NOCs involving the storage and handling operations associated with vented containers on the Hanford Site. The proposed annual release fraction was the largest release fraction calculated from alpha measurements of the NucFil filters from 10 vented containers consisting of nine 55-gallon drums and one burial box with dimensions of 9.3 x 5.7 x 6.4 feet. An annual release fraction of 2.0 E-09 was used in the modification to the CWC radioactive air emissions NOC. This study confirmed that the release fraction used in the CWC radioactive air emissions NOC was conservative

  17. Bariatric surgery in patients with bipolar spectrum disorders: Selection factors, post-operative visit attendance, and weight outcomes

    Science.gov (United States)

    Friedman, Kelli E.; Applegate, Katherine; Portenier, Dana; McVay, Megan

    2017-01-01

    Background As many of 3% of bariatric surgery candidates are diagnosed with a bipolar spectrum disorder. Objectives 1) To describe differences between patients with bipolar spectrum disorders who are approved and not approved for surgery by the mental health evaluator. 2) To examine surgical outcomes of patients with bipolar spectrum disorders. Setting Academic medical center, United States. Methods A retrospective record review was conducted of consecutive patients who applied for bariatric surgery between 2004 and 2009. Patients diagnosed with bipolar spectrum disorders who were approved for surgery (n=42) were compared with patients with a bipolar spectrum disorder who were not approved (n=31) and to matched control surgical patients without a bipolar spectrum diagnosis (n=29) on a variety of characteristics and surgical outcomes. Results Of bariatric surgery candidates diagnosed with a bipolar spectrum disorder who applied for surgery, 57% were approved by the psychologist and 48% ultimately had surgery. Patients with a bipolar spectrum disorder who were approved for surgery were less likely to have had a previous psychiatric hospitalizations than those who were not approved for surgery. Bariatric surgery patients diagnosed with a bipolar spectrum disorder were less likely to attend follow-up care appointments 2 or more years post-surgery compared to matched patients without bipolar disorder. Among patients with available data, those with a bipolar spectrum disorder and matched patients had similar weight loss at 12 months (n=21 for bipolar, n=24 for matched controls) and at 2 or more years (mean=51 months; n=11 for bipolar, n=20 for matched controls). Conclusions Patients diagnosed with a bipolar spectrum disorder have a high rate of delay/denial for bariatric surgery based on the psychosocial evaluation and are less likely to attend medical follow-up care 2 or more years post-surgery. Carefully screened patients with bipolar disorder who engage in long

  18. 77 FR 57104 - Notice of Submission of Proposed Information Collection to OMB; Loan Guarantees for Indian Housing

    Science.gov (United States)

    2012-09-17

    ... service areas. Mortgage lenders approved by HUD provide borrower and lender information to HUD for..., Fannie Mae Form 1005. Description of the Need for the Information and Its Proposed Use The information is... service areas. Mortgage lenders approved by HUD provide borrower and lender information to HUD for...

  19. F(ab'2 antibody fragments against Trypanosoma cruzi calreticulin inhibit its interaction with the first component of human complement

    Directory of Open Access Journals (Sweden)

    LORENA AGUILAR

    2005-01-01

    Full Text Available Trypanosoma cruzi calreticulin (TcCRT, described in our laboratory, retains several important functional features from its vertebrate homologues. We have shown that recombinant TcCRT inhibits the human complement system when it binds to the collagenous portion of C1q. The generation of classical pathway convertases and membrane attack complexes is thus strongly inhibited. In most T. cruzi-infected individuals, TcCRT is immunogenic and mediates the generation of specific antibodies. By reverting the C1q / TcCRT interaction, a parasite immune evasion strategy, these antibodies contribute to the host / parasite equilibrium. In an in vitro correlate of this situation, we show that the C1q / TcCRT interaction is inhibited by F(ab'2 polyclonal anti-TcCRT IgG fragments. It is therefore feasible that in infected humans anti-TcCRT antibodies participate in reverting an important parasite strategy aimed at inhibiting the classical complement pathway. Thus, membrane-bound TcCRT interacts with the collagenous portion C1q, and this C1q is recognized by the CD91-bound host cell CRT, thus facilitating parasite internalization. Based on our in vitro results, it could be proposed that the in vivo interaction between TcCRT and vertebrate C1q could be inhibited by F(ab'2 fragments anti-rTcCRT or against its S functional domain, thus interfering with the internalization process

  20. How to write a research proposal?

    OpenAIRE

    K Sudheesh; Devika Rani Duggappa; S S Nethra

    2016-01-01

    Writing the proposal of a research work in the present era is a challenging task due to the constantly evolving trends in the qualitative research design and the need to incorporate medical advances into the methodology. The proposal is a detailed plan or ?blueprint? for the intended study, and once it is completed, the research project should flow smoothly. Even today, many of the proposals at post-graduate evaluation committees and application proposals for funding are substandard. A search...

  1. Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture

    Directory of Open Access Journals (Sweden)

    Bate R

    2012-07-01

    failure rates among WHO-approved products suggest there may be some weakness in post-marketing surveillance of these products, especially of Chinese-made WHO-approved products. The discrepancy between the failure rate of WHO-approved products from India (2.39% and China (17.65% is cause for concern. It is possible that more of the failures originating in China are counterfeit products, but this cannot be ascertained without greater help from the manufacturers themselves.Keywords: stringent regulatory authority, World Health Organization prequalification program, product approval, counterfeit, India, China

  2. 76 FR 51049 - Notice of Submission of Proposed Information Collection to OMB Public Housing Admissions...

    Science.gov (United States)

    2011-08-17

    ... Proposed Information Collection to OMB Public Housing Admissions/Occupancy Policies AGENCY: Office of the...: Public Housing Admissions/Occupancy Policies. OMB Approval Number: 2577-0220. Form Numbers: None... the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal...

  3. Gynecologic Malignancies Post-LeFort Colpocleisis

    Directory of Open Access Journals (Sweden)

    Rayan Elkattah

    2014-01-01

    Full Text Available Introduction. LeFort colpocleisis (LFC is a safe and effective obliterative surgical option for older women with advanced pelvic organ prolapse who no longer desire coital activity. A major disadvantage is the limited ability to evaluate for post-LFC gynecologic malignancies. Methods. We present the first case of endometrioid ovarian cancer diagnosed after LFC and review all reported gynecologic malignancies post-LFC in the English medical literature. Results. This is the second reported ovarian cancer post-LFC and the first of the endometrioid subtype. A total of nine other gynecologic malignancies post-LFC have been reported in the English medical literature. Conclusions. Gynecologic malignancies post-LFC are rare. We propose a simple 3-step strategy in evaluating post-LFC malignancies.

  4. The operation of post-irradiation examination facility

    International Nuclear Information System (INIS)

    Kim, Eun Ka; Min, Duk Ki; Lee, Young Kil

    1994-12-01

    The operation of post-irradiation examination facility was performed as follow. HVAC and pool water treatment system were continuously operated, and radiation monitoring in PIE facility has been carried out to maintain the facility safely. Inspection of the fuel assembly (F02) transported from Kori Unit 1 was performed in pool, and fuel rods extracted from the fuel assembly (J44) of Kori Unit 2 NPP were examined in hot cell. A part of deteriorated pipe line of drinking water was exchanged for stainless steel pipe to prevent leaking accidents. Halon gas system was also installed in the exhausting blower room for fire fighting. And IAEA inspection camera for safeguard of nuclear materials was fixed at the wall in pool area. Radiation monitoring system were improved to display the area radioactive value at CRT monitor in health physics control room. And automatic check system for battery and emergency diesel generator was developed to measure the voltage and current of them. The performance test of oxide thickness measuring device installed in hot cell for irradiated fuel rod and improvement of the device were performed, and good measuring results using standard sample were obtained. The safeguard inspection of nuclear materials and operation inspection of the facility were carried out through the annual operation inspection, quarterly IAEA inspection and quality assurance auditing. 26 tabs., 43 figs., 14 refs. (Author) .new

  5. Proposed Approval of California Air Plan Revision; San Joaquin Valley Unified Air Pollution Control District; Reasonably Available Control Technology Demonstration

    Science.gov (United States)

    EPA isproposing to approve revisions to the SJVUAPCD portion of the California SIP applying to the San Joaquin Valley of California concerning demonstration regarding RACT requirements for the 2008 8-hour ozone National Ambient Air Quality Standard (NAAQS)

  6. 75 FR 40760 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Volatile Organic...

    Science.gov (United States)

    2010-07-14

    ... Implementation Plan for Abbott Laboratories AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule... its SIP. These amendments consist of a site- specific rulemaking for certain of Abbott Laboratories' (Abbott) tunnel dryers and fluid bed dryers. This site-specific rule revision is approvable because it...

  7. Randomised and non-randomised studies to estimate the effect of community-level public health interventions: definitions and methodological considerations.

    Science.gov (United States)

    Schmidt, Wolf-Peter

    2017-01-01

    The preferred method to evaluate public health interventions delivered at the level of whole communities is the cluster randomised trial (CRT). The practical limitations of CRTs and the need for alternative methods continue to be debated. There is no consensus on how to classify study designs to evaluate interventions, and how different design features are related to the strength of evidence. This article proposes that most study designs for the evaluation of cluster-level interventions fall into four broad categories: the CRT, the non-randomised cluster trial (NCT), the controlled before-and-after study (CBA), and the before-and-after study without control (BA). A CRT needs to fulfil two basic criteria: (1) the intervention is allocated at random; (2) there are sufficient clusters to allow a statistical between-arm comparison. In a NCT, statistical comparison is made across trial arms as in a CRT, but treatment allocation is not random. The defining feature of a CBA is that intervention and control arms are not compared directly, usually because there are insufficient clusters in each arm to allow a statistical comparison. Rather, baseline and follow-up measures of the outcome of interest are compared in the intervention arm, and separately in the control arm. A BA is a CBA without a control group. Each design may provide useful or misleading evidence. A precise baseline measurement of the outcome of interest is critical for causal inference in all studies except CRTs. Apart from statistical considerations the exploration of pre/post trends in the outcome allows a more transparent discussion of study weaknesses than is possible in non-randomised studies without a baseline measure.

  8. Risk of isolated nodal failure for non-small cell lung cancer (NSCLC) treated with the elective nodal irradiation (ENI) using 3D-conformal radiotherapy (3D-CRT) techniques--a retrospective analysis.

    Science.gov (United States)

    Kepka, Lucyna; Bujko, Krzysztof; Zolciak-Siwinska, Agnieszka

    2008-01-01

    To estimate retrospectively the rate of isolated nodal failures (INF) in NSCLC patients treated with the elective nodal irradiation (ENI) using 3D-conformal radiotherapy (3D-CRT). One hundred and eighty-five patients with I-IIIB stage treated with 3D-CRT in consecutive clinical trials differing in an extent of the ENI were analyzed. According to the extent of the ENI, two groups were distinguished: extended (n = 124) and limited (n = 61) ENI. INF was defined as regional nodal failure occurring without local progression. Cumulative Incidence of INF (CIINF) was evaluated by univariate and multivariate analysis with regard to prognostic factors. With a median follow up of 30 months, the two-year actuarial overall survival was 35%. The two-year CIINF rate was 12%. There were 16 (9%) INF, eight (6%) for extended and eight (13%) for limited ENI. In the univariate analysis bulky mediastinal disease (BMD), left side, higher N stage, and partial response to RT had a significant negative impact on the CIINF. BMD was the only independent predictor of the risk of incidence of the INF (p = 0.001). INF is more likely to occur in case of more advanced nodal status.

  9. 78 FR 57319 - Children's Online Privacy Protection Rule Safe Harbor Proposed Self-Regulatory Guidelines...

    Science.gov (United States)

    2013-09-18

    ...-AB20 Children's Online Privacy Protection Rule Safe Harbor Proposed Self-Regulatory Guidelines; kidSAFE... proposed self-regulatory guidelines submitted by the kidSAFE Seal Program (``kidSAFE''), owned and operated... enabling industry groups or others to submit to the Commission for approval self-regulatory guidelines that...

  10. Electronic Approval of Invoices (AEF)

    CERN Document Server

    2004-01-01

    With a view to the simplification of administrative procedures, AS and FI Departments have completed the second phase of the new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. Phase II includes handling the electronic approval process of invoices whose amounts do not correspond exactly to those of the associated orders. In such cases, budgetary approval is required for the entire invoiced amount. Further information can be obtained at : http://ais.cern.ch/projs/AEF/help/F_help.htm Phase II of the procedure will be introduced gradually with effect from April 2004. Finance Department, Accounts Payable Section Tel: 72295 Organisation and Procedures Tel: 75885 Information Technologies Department,...

  11. 78 FR 26300 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Revisions to Control of Air...

    Science.gov (United States)

    2013-05-06

    .... First, we are proposing to approve revisions to Texas SIP, Chapter 117 emissions specifications for lean... curing ovens used in wet-laid non-woven fiber mat manufacturing operations when nitrogen containing...

  12. 78 FR 59754 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System

    Science.gov (United States)

    2013-09-27

    ..., LLC, Ms. Rhonda Nicoloff, Managing Member, 1505 South Redwood Road, Salt Lake City, UT 84104. GRYR seeks approval of the proposed discontinuance and removal of the automatic block signal (ABS) system...

  13. 78 FR 14822 - Proposed Information Collection; National Park Service Concessions

    Science.gov (United States)

    2013-03-07

    ... together with, if requested by the NPS, a written certification from a certified public accountant (CPA... and respondent burden, we invite the general public and other Federal agencies to take this...: (1) Proposals (partially approved under OMB Control Number 1024- 0125). The public solicitation...

  14. Human trafficking and U.S. government responses post- 9/11

    OpenAIRE

    DeCeoursty, Kevin D.

    2016-01-01

    Approved for public release; distribution is unlimited The thesis examines the effectiveness of U.S. government anti-human trafficking efforts in the post- 9/11 environment. The body of human trafficking literature has revealed four common themes: human agency, labor rights, the sex industry, and crime control. The thesis examines five federal departments that were selected based on their relative experience, expertise, and operational mandates. Open source statistical data and other infor...

  15. 75 FR 52351 - Proposed Collection; Comment Request; Request; OMB No. 0925-0177 “Special Volunteer and Guest...

    Science.gov (United States)

    2010-08-25

    ... Resources, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed... proposed collection of information, including the validity of the methodology and assumptions used; (3...

  16. 77 FR 62518 - Proposed Collection; Comment Request: Recipient Epidemiology and Donor Evaluation Study-III (REDS...

    Science.gov (United States)

    2012-10-15

    ... of proposed projects to the Office of Management and Budget (OMB) for review and approval. Proposed... learned, including how donor genetic or environmental factors may affect the quality of collected blood components and influence non-infectious transfusion complications in recipients. Additionally, there is...

  17. 76 FR 69743 - Proposed Collection; Comment Request; Application for Collaboration With the NIH Center for...

    Science.gov (United States)

    2011-11-09

    ..., for opportunity for public comment on proposed data collection projects, the (insert name of NIH... projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed... chemistry, lead optimization, chemical biology studies, drug development capabilities, expertise, and...

  18. Marketing Approval of Ethical Kampo Medicines.

    Science.gov (United States)

    Hakamatsuka, Takashi

    2017-01-01

    Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

  19. 40 CFR 145.31 - Approval process.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Approval process. 145.31 Section 145.31 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) STATE UIC PROGRAM REQUIREMENTS Program Approval, Revision and Withdrawal § 145.31 Approval process. (a...

  20. 40 CFR 52.2122 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... sources covered by CTGs issued by the previous January. (b) EPA disapproved South Carolina's generic...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) South Carolina § 52.2122 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves South Carolina's plans for...