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Sample records for primary endpoint results

  1. Primary endpoint results of the OMEGA Study: One-year clinical outcomes after implantation of a novel platinum chromium bare metal stent

    Energy Technology Data Exchange (ETDEWEB)

    Wang, John C., E-mail: john.wang@medstar.net [MedStar Union Memorial Hospital, Baltimore MD (United States); Carrié, Didier, E-mail: carrie.didier@chu-toulouse.fr [Centre Hôpital Universitaire Rangueil, Toulouse (France); Masotti, Monica, E-mail: MASOTTI@clinic.ub.es [Hospital Clinic, University of Barcelona (Spain); Erglis, Andrejs, E-mail: a.a.erglis@stradini.lv [Pauls Stradins Clinical University Hospital, University of Latvia, Riga (Latvia); Mego, David, E-mail: David.Mego@arheart.com [Arkansas Heart Hospital, Little Rock, AR (United States); Watkins, Matthew W., E-mail: Matthew.Watkins@vtmednet.org [University of Vermont Medical Center, Burlington VT (United States); Underwood, Paul, E-mail: Paul.underwood@bsci.com [Boston Scientific, Marlborough MA USA (United States); Allocco, Dominic J., E-mail: Dominic.allocco@bsci.com [Boston Scientific, Marlborough MA USA (United States); Hamm, Christian W., E-mail: C.Hamm@kerckhoff-klinik.de [Kerckhoff Heart and Thoraxcenter, Bad Nauheim (Germany)

    2015-03-15

    Background/purpose: Bare metal stents (BMS) have similar rates of death and myocardial infarction (MI) compared to drug-eluting stents (DES). DES lower repeat revascularization rates compared to BMS, but may have higher rates of late stent thrombosis (ST) potentially due to impaired endothelialization requiring longer dual anti-platelet therapy (DAPT). OMEGA evaluated a novel BMS designed to have improved deliverability and radiopacity, in comparison to currently available platforms. Methods/materials: OMEGA was a prospective, multicenter, single-arm study enrolling 328 patients at 37 sites (US and Europe). Patients received the OMEGA stent (bare platinum chromium element stent) for the treatment of de novo native coronary artery lesions (≤ 28 mm long; diameter ≥ 2.25 mm to ≤ 4.50 mm). The primary endpoint was 9-month target lesion failure (TLF: cardiac death, target vessel-related MI, target lesion revascularization [TLR]) compared to a prespecified performance goal (PG) based on prior generation BMS. All major cardiac events were independently adjudicated. DAPT was required for a minimum of 1 month post procedure. Results: In the OMEGA study, the mean age was 65; 17% had diabetes mellitus. The primary endpoint was met; 9 month TLF rate was 11.5%, and the upper 1-sided 95% confidence bound of 14.79% was less than the prespecified PG of 21.2% (p < 0.0001). One-year event rates were low including a TLF rate of 12.8% and an ST rate of 0.6% at 12 months. Conclusions: One-year outcomes of OMEGA show low rates of TLF, revascularization and ST. This supports safety and efficacy of the OMEGA BMS for the treatment of coronary artery disease. - Highlights: • The OMEGA study evaluated a novel platinum chromium bare metal stent. • OMEGA enrolled 328 patients at 37 sites (US and Europe). • The primary endpoint of 9 month target lesion failure was 11.5%. • One-year event rates were low including an ST rate of 0.6% at 12 months.

  2. Primary endpoint results of the OMEGA Study: One-year clinical outcomes after implantation of a novel platinum chromium bare metal stent

    International Nuclear Information System (INIS)

    Wang, John C.; Carrié, Didier; Masotti, Monica; Erglis, Andrejs; Mego, David; Watkins, Matthew W.; Underwood, Paul; Allocco, Dominic J.; Hamm, Christian W.

    2015-01-01

    Background/purpose: Bare metal stents (BMS) have similar rates of death and myocardial infarction (MI) compared to drug-eluting stents (DES). DES lower repeat revascularization rates compared to BMS, but may have higher rates of late stent thrombosis (ST) potentially due to impaired endothelialization requiring longer dual anti-platelet therapy (DAPT). OMEGA evaluated a novel BMS designed to have improved deliverability and radiopacity, in comparison to currently available platforms. Methods/materials: OMEGA was a prospective, multicenter, single-arm study enrolling 328 patients at 37 sites (US and Europe). Patients received the OMEGA stent (bare platinum chromium element stent) for the treatment of de novo native coronary artery lesions (≤ 28 mm long; diameter ≥ 2.25 mm to ≤ 4.50 mm). The primary endpoint was 9-month target lesion failure (TLF: cardiac death, target vessel-related MI, target lesion revascularization [TLR]) compared to a prespecified performance goal (PG) based on prior generation BMS. All major cardiac events were independently adjudicated. DAPT was required for a minimum of 1 month post procedure. Results: In the OMEGA study, the mean age was 65; 17% had diabetes mellitus. The primary endpoint was met; 9 month TLF rate was 11.5%, and the upper 1-sided 95% confidence bound of 14.79% was less than the prespecified PG of 21.2% (p < 0.0001). One-year event rates were low including a TLF rate of 12.8% and an ST rate of 0.6% at 12 months. Conclusions: One-year outcomes of OMEGA show low rates of TLF, revascularization and ST. This supports safety and efficacy of the OMEGA BMS for the treatment of coronary artery disease. - Highlights: • The OMEGA study evaluated a novel platinum chromium bare metal stent. • OMEGA enrolled 328 patients at 37 sites (US and Europe). • The primary endpoint of 9 month target lesion failure was 11.5%. • One-year event rates were low including an ST rate of 0.6% at 12 months

  3. Considerations in choosing a primary endpoint that measures durability of virological suppression in an antiretroviral trial.

    Science.gov (United States)

    Gilbert, P B; Ribaudo, H J; Greenberg, L; Yu, G; Bosch, R J; Tierney, C; Kuritzkes, D R

    2000-09-08

    At present, many clinical trials of anti-HIV-1 therapies compare treatments by a primary endpoint that measures the durability of suppression of HIV-1 replication. Several durability endpoints are compared. Endpoints are compared by their implicit assumptions regarding surrogacy for clinical outcomes, sample size requirements, and accommodations for inter-patient differences in baseline plasma HIV-1-RNA levels and in initial treatment response. Virological failure is defined by the non-suppression of virus levels at a prespecified follow-up time T(early virological failure), or by relapse. A binary virological failure endpoint is compared with three time-to-virological failure endpoints: time from (i) randomization that assigns early failures a failure time of T weeks; (ii) randomization that extends the early failure time T for slowly responding subjects; and (iii) virological response that assigns non-responders a failure time of 0 weeks. Endpoint differences are illustrated with Agouron's trial 511. In comparing high with low-dose nelfinavir (NFV) regimens in Agouron 511, the difference in Kaplan-Meier estimates of the proportion not failing by 24 weeks is 16.7% (P = 0.048), 6.5% (P = 0.29) and 22.9% (P = 0.0030) for endpoints (i), (ii) and (iii), respectively. The results differ because NFV suppresses virus more quickly at the higher dose, and the endpoints weigh this treatment difference differently. This illustrates that careful consideration needs to be given to choosing a primary endpoint that will detect treatment differences of interest. A time from randomization endpoint is usually recommended because of its advantages in flexibility and sample size, especially at interim analyses, and for its interpretation for patient management.

  4. Efficacy and safety of once-weekly GLP-1 receptor agonist albiglutide (HARMONY 2): 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise.

    Science.gov (United States)

    Nauck, Michael A; Stewart, Murray W; Perkins, Christopher; Jones-Leone, Angela; Yang, Fred; Perry, Caroline; Reinhardt, Rickey R; Rendell, Marc

    2016-02-01

    Additional safe and effective therapies for type 2 diabetes are needed, especially ones that do not cause weight gain and have a low risk of hypoglycaemia. The present study evaluated albiglutide as monotherapy. In this placebo-controlled study, 309 patients (aged ≥ 18 years) with type 2 diabetes inadequately controlled by diet and exercise and who were not using a glucose-lowering agent (HbA1c 7.0-10.0% [53.00-85.79 mmol/mol], body mass index 20-45 kg/m(2), and fasting C-peptide ≥ 0.26 nmol/l) were randomised (1:1:1 on a fixed randomisation schedule using an interactive voice response system) to receive once-weekly albiglutide 30 mg (n = 102) or 50 mg (n = 102) or matching placebo (n = 105). The study treatments were blinded to both patients and study personnel. All study data were collected at individual patient clinic visits. The primary efficacy endpoint was change in HbA1c from baseline to week 52. The primary analysis was applied to the intent-to-treat population. Additional efficacy and safety endpoints were assessed. At week 52, both albiglutide 30 mg and 50 mg were superior to placebo in reducing HbA1c. The least-squares means treatment difference from placebo was -0.84% (95% CI -1.11%, -0.58%; p < 0.0001) with albiglutide 30 mg and -1.04% (-1.31%, -0.77%; p < 0.0001) with albiglutide 50 mg. Injection-site reactions were reported more frequently with albiglutide (30 mg: 17.8%; 50 mg: 22.2%) than with placebo (9.9%). Other commonly reported adverse events included nausea, diarrhoea, vomiting and hypoglycaemia; the incidences of these were generally similar across treatment groups. Albiglutide is safe and effective as monotherapy and significantly lowered HbA1c levels over 52 weeks, did not cause weight gain, and had good gastrointestinal tolerability and a low rate of hypoglycaemia compared with placebo. Trial registration ClinicalTrials.gov NCT00849017 Funding This study was sponsored by GlaxoSmithKline.

  5. Reducing sample size by combining superiority and non-inferiority for two primary endpoints in the Social Fitness study.

    Science.gov (United States)

    Donkers, Hanneke; Graff, Maud; Vernooij-Dassen, Myrra; Nijhuis-van der Sanden, Maria; Teerenstra, Steven

    2017-01-01

    In randomized controlled trials, two endpoints may be necessary to capture the multidimensional concept of the intervention and the objectives of the study adequately. We show how to calculate sample size when defining success of a trial by combinations of superiority and/or non-inferiority aims for the endpoints. The randomized controlled trial design of the Social Fitness study uses two primary endpoints, which can be combined into five different scenarios for defining success of the trial. We show how to calculate power and sample size for each scenario and compare these for different settings of power of each endpoint and correlation between them. Compared to a single primary endpoint, using two primary endpoints often gives more power when success is defined as: improvement in one of the two endpoints and no deterioration in the other. This also gives better power than when success is defined as: improvement in one prespecified endpoint and no deterioration in the remaining endpoint. When two primary endpoints are equally important, but a positive effect in both simultaneously is not per se required, the objective of having one superior and the other (at least) non-inferior could make sense and reduce sample size. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. An evaluation of culture results during treatment for tuberculosis as surrogate endpoints for treatment failure and relapse.

    Directory of Open Access Journals (Sweden)

    Patrick P J Phillips

    Full Text Available It is widely acknowledged that new regimens are urgently needed for the treatment of tuberculosis. The primary endpoint in the Phase III trials is a composite outcome of failure at the end of treatment or relapse after stopping treatment. Such trials are usually both long and expensive. Valid surrogate endpoints measured during or at the end of treatment could dramatically reduce both the time and cost of assessing the effectiveness of new regimens. The objective of this study was to evaluate sputum culture results on solid media during treatment as surrogate endpoints for poor outcome. Data were obtained from twelve randomised controlled trials conducted by the British Medical Research Council in the 1970s and 80s in East Africa and East Asia, consisting of 6974 participants and 49 different treatment regimens. The month two culture result was shown to be a poor surrogate in East Africa but a good surrogate in Hong Kong. In contrast, the month three culture was a good surrogate in trials conducted in East Africa but not in Hong Kong. As well as differences in location, ethnicity and probable strain of Mycobacteria tuberculosis, Hong Kong trials more often evaluated regimens with rifampicin throughout and intermittent regimens, and patients in East African trials more often presented with extensive cavitation and were slower to convert to culture negative during treatment. An endpoint that is a summary measure of the longitudinal profile of culture results over time or that is able to detect the presence of M. tuberculosis later in treatment is more likely to be a better endpoint for a phase II trial than a culture result at a single time point and may prove to be an acceptable surrogate. More data are needed before any endpoint can be used as a surrogate in a confirmatory phase III trial.

  7. Biomarkers of Host Response Predict Primary End-Point Radiological Pneumonia in Tanzanian Children with Clinical Pneumonia: A Prospective Cohort Study

    Science.gov (United States)

    Erdman, Laura K.; D’Acremont, Valérie; Hayford, Kyla; Kilowoko, Mary; Kyungu, Esther; Hongoa, Philipina; Alamo, Leonor; Streiner, David L.; Genton, Blaise; Kain, Kevin C.

    2015-01-01

    Background Diagnosing pediatric pneumonia is challenging in low-resource settings. The World Health Organization (WHO) has defined primary end-point radiological pneumonia for use in epidemiological and vaccine studies. However, radiography requires expertise and is often inaccessible. We hypothesized that plasma biomarkers of inflammation and endothelial activation may be useful surrogates for end-point pneumonia, and may provide insight into its biological significance. Methods We studied children with WHO-defined clinical pneumonia (n = 155) within a prospective cohort of 1,005 consecutive febrile children presenting to Tanzanian outpatient clinics. Based on x-ray findings, participants were categorized as primary end-point pneumonia (n = 30), other infiltrates (n = 31), or normal chest x-ray (n = 94). Plasma levels of 7 host response biomarkers at presentation were measured by ELISA. Associations between biomarker levels and radiological findings were assessed by Kruskal-Wallis test and multivariable logistic regression. Biomarker ability to predict radiological findings was evaluated using receiver operating characteristic curve analysis and Classification and Regression Tree analysis. Results Compared to children with normal x-ray, children with end-point pneumonia had significantly higher C-reactive protein, procalcitonin and Chitinase 3-like-1, while those with other infiltrates had elevated procalcitonin and von Willebrand Factor and decreased soluble Tie-2 and endoglin. Clinical variables were not predictive of radiological findings. Classification and Regression Tree analysis generated multi-marker models with improved performance over single markers for discriminating between groups. A model based on C-reactive protein and Chitinase 3-like-1 discriminated between end-point pneumonia and non-end-point pneumonia with 93.3% sensitivity (95% confidence interval 76.5–98.8), 80.8% specificity (72.6–87.1), positive likelihood ratio 4.9 (3.4–7

  8. Note on simultaneous inferences about non-inferiority and superiority for a primary and a secondary endpoint.

    Science.gov (United States)

    Guilbaud, Olivier

    2011-11-01

    In their review of challenges to multiple testing in clinical trials, Hung and Wang (2010) considered the situation where a treatment is to be compared with an active comparator and the aim is to show non-inferiority and (if possible) superiority with respect to a primary and a secondary endpoint. This note extends their discussion of this particular situation, taking the sequentially rejective procedure they used for illustration as a starting point. Some alternative multiple testing procedures (MTPs) are considered, and corresponding simultaneous confidence regions are discussed that provide additional information "for free". The choice may then be based on the properties of these MTPs and corresponding confidence regions. 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  9. Factors Influencing Depression Endpoints Research (FINDER: baseline results of Italian patients with depression

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    Grassi Luigi

    2009-05-01

    Full Text Available Abstract Background Factors Influencing Depression Endpoints Research (FINDER is a 6-month, prospective, observational study carried out in 12 European countries aimed at investigating health-related quality of life (HRQoL in outpatients receiving pharmacological treatment for a first or new depressive episode. Baseline characteristics of patients enrolled in Italy are presented. Methods All treatment decisions were at the discretion of the investigator. Data were collected at baseline and after 3 and 6 months of treatment. Baseline evaluations included demographics, medical and psychiatric history, and medications used in the last 24 months and prescribed at enrolment. The Hospital Anxiety and Depression Scale (HADS, was adopted to evaluate depressive symptoms, while somatic and painful physical symptoms were assessed by using the Somatic Symptom Inventory (SSI and a 0 to 100 mm visual analogue scale (VAS, HRQoL via 36-item Short Form Health Survey (SF-36, and the European Quality of Life 5-Dimensions (EQ-5D instrument. Results A total of 513 patients were recruited across 38 sites. The mean ± standard deviation (SD age at first depressive episode was 38.7 ± 15.9 years, the mean duration of depression 10.6 ± 12.3 years. The most common psychiatric comorbidities in the previous 24 months were anxiety/panic (72.6% and obsessive/compulsive disorders (13.4%, while 35.9% had functional somatic syndromes. Most patients (65.1% reported pain from any cause. Monotherapy with selective serotonin reuptake inhibitors (SSRIs and tricyclic antidepressants (TCAs was prescribed at enrolment in 64.5% and 6.4% of the cases, respectively. The most commonly prescribed agents were sertraline (17.3%, escitalopram (16.2%, venlaflaxine (15.6% and paroxetine (14.8%. The mean HADS subscores for depression and anxiety were 13.3 ± 4.2 and 12.2 ± 3.9, respectively; 76.4% of patients could be defined as being 'probable cases' for depression and 66.2% for anxiety. The

  10. The Factors Influencing Depression Endpoints Research (FINDER study: final results of Italian patients with depression

    Directory of Open Access Journals (Sweden)

    Quail Deborah

    2010-07-01

    Full Text Available Abstract Background Factors Influencing Depression Endpoints Research (FINDER is a 6-month, prospective, observational study carried out in 12 European countries aimed at investigating health-related quality of life (HRQoL in outpatients receiving treatment for a first or new depressive episode. The Italian HRQoL data at 6 months is described in this report, and the factors associated with HRQoL changes were determined. Methods Data were collected at baseline, 3 and 6 months of treatment. HRQoL was measured using components of the 36-item Short Form Health Survey (SF-36; mental component summary (MCS, physical component summary (PCS and the European Quality of Life-5 Dimensions (EQ-5D; visual analogue scale (VAS and health status index (HSI. The Hospital Anxiety and Depression Scale (HADS was adopted to evaluate depressive symptoms, while somatic and painful physical symptoms were assessed by using the 28-item Somatic Symptom Inventory (SSI-28 and a VAS. Results Of the initial 513 patients, 472 completed the 3-month observation and 466 the 6-month observation. The SF-36 and EQ-5D mean (± SD scores showed HRQoL improvements at 3 months and a further smaller improvement at 6 months, with the most positive effects for SF-36 MCS (baseline 22.0 ± 9.2, 3 months 34.6 ± 10.0; 6 months 39.3 ± 9.5 and EQ-5D HSI (baseline 0.4 ± 0.3; 3 months 0.7 ± 0.3; 6 months 0.7 ± 0.2. Depression and anxiety symptoms (HADS-D mean at baseline 13.3 ± 4.2; HADS-A mean at baseline 12.2 ± 3.9 consistently decreased during the first 3 months (8.7 ± 4.3; 7.5 ± 3.6 and showed a further positive change at 6 months (6.9 ± 4.3; 5.8 ± 3.4. Somatic and painful symptoms (SSI and VAS significantly decreased, with the most positive changes in the SSI-28 somatic item (mean at baseline 2.4 ± 0.7; mean change at 3 months: -0.5; 95% CI -0.6 to -0.5; mean change at 6 months: -0.7; 95% CI -0.8 to -0.7; in 'interference of overall pain with daily activities' (mean at baseline 45

  11. Inconsistent approaches of the G-BA regarding acceptance of primary study endpoints as being relevant to patients - an analysis of three disease areas: oncological, metabolic, and infectious diseases

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    Thomas Staab

    2016-11-01

    Full Text Available Abstract Background Previous evaluations of oncological medicines in the German early benefit assessment (EBA procedure have demonstrated inconsistent acceptance of endpoints by regulatory authorities and the Federal Joint Committee (G-BA. Accepted standard endpoints for regulatory purposes are frequently not considered as patient-relevant in the German EBA system. In this study the acceptance of clinically acknowledged primary endpoints (PEPs from regulatory trials in EBAs conducted by the G-BA was evaluated across three therapeutic areas. Methods Medicines for oncological, metabolic and infectious diseases with EBAs finalised before 25 January 2016 were evaluated. Respective manufacturer’s dossiers, regulatory assessments, G-BA appraisals and oral hearing minutes were reviewed, and PEPs were examined to determine whether they were considered relevant to patients by the G-BA. Furthermore, the acceptance of symptomatic vs asymptomatic PEPs was also analysed. Results A total of 65 EBAs were evaluated. Mortality PEPs were widely accepted as patient-relevant but were only used in a minority of EBAs and exclusively in oncological diseases. Morbidity PEPs constituted around 72 % of assessed PEPs, but were excluded from the EBA in over half of the corresponding assessments as they were not considered patient-relevant. Symptomatic endpoints were largely deemed patient-relevant, whereas acceptance of asymptomatic endpoints varied between therapeutic areas. Conclusions This evaluation identified inconsistencies in patient relevance of morbidity-related PEPs as well as in acceptance of asymptomatic endpoints by the G-BA in all three disease areas examined. Better harmonisation between the regulatory authorities and the G-BA is still required after 5 years of AMNOG health technology assessment in Germany.

  12. Biomarkers of Host Response Predict Primary End-Point Radiological Pneumonia in Tanzanian Children with Clinical Pneumonia: A Prospective Cohort Study.

    Directory of Open Access Journals (Sweden)

    Laura K Erdman

    Full Text Available Diagnosing pediatric pneumonia is challenging in low-resource settings. The World Health Organization (WHO has defined primary end-point radiological pneumonia for use in epidemiological and vaccine studies. However, radiography requires expertise and is often inaccessible. We hypothesized that plasma biomarkers of inflammation and endothelial activation may be useful surrogates for end-point pneumonia, and may provide insight into its biological significance.We studied children with WHO-defined clinical pneumonia (n = 155 within a prospective cohort of 1,005 consecutive febrile children presenting to Tanzanian outpatient clinics. Based on x-ray findings, participants were categorized as primary end-point pneumonia (n = 30, other infiltrates (n = 31, or normal chest x-ray (n = 94. Plasma levels of 7 host response biomarkers at presentation were measured by ELISA. Associations between biomarker levels and radiological findings were assessed by Kruskal-Wallis test and multivariable logistic regression. Biomarker ability to predict radiological findings was evaluated using receiver operating characteristic curve analysis and Classification and Regression Tree analysis.Compared to children with normal x-ray, children with end-point pneumonia had significantly higher C-reactive protein, procalcitonin and Chitinase 3-like-1, while those with other infiltrates had elevated procalcitonin and von Willebrand Factor and decreased soluble Tie-2 and endoglin. Clinical variables were not predictive of radiological findings. Classification and Regression Tree analysis generated multi-marker models with improved performance over single markers for discriminating between groups. A model based on C-reactive protein and Chitinase 3-like-1 discriminated between end-point pneumonia and non-end-point pneumonia with 93.3% sensitivity (95% confidence interval 76.5-98.8, 80.8% specificity (72.6-87.1, positive likelihood ratio 4.9 (3.4-7.1, negative likelihood ratio 0

  13. Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials)

    NARCIS (Netherlands)

    Bonnetain, Franck; Bonsing, Bert; Conroy, Thierry; Dousseau, Adelaide; Glimelius, Bengt; Haustermans, Karin; Lacaine, François; van Laethem, Jean Luc; Aparicio, Thomas; Aust, Daniela; Bassi, Claudio; Berger, Virginie; Chamorey, Emmanuel; Chibaudel, Benoist; Dahan, Laeticia; de Gramont, Aimery; Delpero, Jean Robert; Dervenis, Christos; Ducreux, Michel; Gal, Jocelyn; Gerber, Erich; Ghaneh, Paula; Hammel, Pascal; Hendlisz, Alain; Jooste, Valérie; Labianca, Roberto; Latouche, Aurelien; Lutz, Manfred; Macarulla, Teresa; Malka, David; Mauer, Muriel; Mitry, Emmanuel; Neoptolemos, John; Pessaux, Patrick; Sauvanet, Alain; Tabernero, Josep; Taieb, Julien; van Tienhoven, Geertjan; Gourgou-Bourgade, Sophie; Bellera, Carine; Mathoulin-Pélissier, Simone; Collette, Laurence

    2014-01-01

    Using potential surrogate end-points for overall survival (OS) such as Disease-Free- (DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled trials (RCTs). However, end-points are too often imprecisely defined which largely contributes to a lack of homogeneity across

  14. TBI Endpoints Development

    Science.gov (United States)

    2015-10-01

    therapy , and early mild physical activity, which result in fewer symptoms, lower mean severity of symptoms, less social disability, and fewer days off work...developing more precise TBI diagnostic tools, clinical endpoints, and effective therapies . We designed and executed an interactive program that combined...surgery, neuropsychology, neuroradiology, psychiatry, neurology, sports medicine, pediatrics, geriatrics , health economics, biostatistics, and informatics

  15. Planning and analyzing clinical trials with composite endpoints

    CERN Document Server

    Rauch, Geraldine; Kieser, Meinhard

    2017-01-01

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

  16. Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials).

    Science.gov (United States)

    Bonnetain, Franck; Bonsing, Bert; Conroy, Thierry; Dousseau, Adelaide; Glimelius, Bengt; Haustermans, Karin; Lacaine, François; Van Laethem, Jean Luc; Aparicio, Thomas; Aust, Daniela; Bassi, Claudio; Berger, Virginie; Chamorey, Emmanuel; Chibaudel, Benoist; Dahan, Laeticia; De Gramont, Aimery; Delpero, Jean Robert; Dervenis, Christos; Ducreux, Michel; Gal, Jocelyn; Gerber, Erich; Ghaneh, Paula; Hammel, Pascal; Hendlisz, Alain; Jooste, Valérie; Labianca, Roberto; Latouche, Aurelien; Lutz, Manfred; Macarulla, Teresa; Malka, David; Mauer, Muriel; Mitry, Emmanuel; Neoptolemos, John; Pessaux, Patrick; Sauvanet, Alain; Tabernero, Josep; Taieb, Julien; van Tienhoven, Geertjan; Gourgou-Bourgade, Sophie; Bellera, Carine; Mathoulin-Pélissier, Simone; Collette, Laurence

    2014-11-01

    Using potential surrogate end-points for overall survival (OS) such as Disease-Free- (DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled trials (RCTs). However, end-points are too often imprecisely defined which largely contributes to a lack of homogeneity across trials, hampering comparison between them. The aim of the DATECAN (Definition for the Assessment of Time-to-event End-points in CANcer trials)-Pancreas project is to provide guidelines for standardised definition of time-to-event end-points in RCTs for pancreatic cancer. Time-to-event end-points currently used were identified from a literature review of pancreatic RCT trials (2006-2009). Academic research groups were contacted for participation in order to select clinicians and methodologists to participate in the pilot and scoring groups (>30 experts). A consensus was built after 2 rounds of the modified Delphi formal consensus approach with the Rand scoring methodology (range: 1-9). For pancreatic cancer, 14 time to event end-points and 25 distinct event types applied to two settings (detectable disease and/or no detectable disease) were considered relevant and included in the questionnaire sent to 52 selected experts. Thirty experts answered both scoring rounds. A total of 204 events distributed over the 14 end-points were scored. After the first round, consensus was reached for 25 items; after the second consensus was reached for 156 items; and after the face-to-face meeting for 203 items. The formal consensus approach reached the elaboration of guidelines for standardised definitions of time-to-event end-points allowing cross-comparison of RCTs in pancreatic cancer. Copyright © 2014 Elsevier Ltd. All rights reserved.

  17. Calorimetry end-point predictions

    International Nuclear Information System (INIS)

    Fox, M.A.

    1981-01-01

    This paper describes a portion of the work presently in progress at Rocky Flats in the field of calorimetry. In particular, calorimetry end-point predictions are outlined. The problems associated with end-point predictions and the progress made in overcoming these obstacles are discussed. The two major problems, noise and an accurate description of the heat function, are dealt with to obtain the most accurate results. Data are taken from an actual calorimeter and are processed by means of three different noise reduction techniques. The processed data are then utilized by one to four algorithms, depending on the accuracy desired to determined the end-point

  18. Endpoints in pediatric pain studies

    NARCIS (Netherlands)

    M. van Dijk (Monique); I. Ceelie (Ilse); D. Tibboel (Dick)

    2011-01-01

    textabstractAssessing pain intensity in (preverbal) children is more difficult than in adults. Tools to measure pain are being used as primary endpoints [e.g., pain intensity, time to first (rescue) analgesia, total analgesic consumption, adverse effects, and long-term effects] in studies on the

  19. Gene expression as a sensitive endpoint to evaluate cell differentiation and maturation of the developing central nervous system in primary cultures of rat cerebellar granule cells (CGCs) exposed to pesticides

    International Nuclear Information System (INIS)

    Hogberg, Helena T.; Kinsner-Ovaskainen, Agnieszka; Hartung, Thomas; Coecke, Sandra; Bal-Price, Anna K.

    2009-01-01

    The major advantage of primary neuronal cultures for developmental neurotoxicity (DNT) testing is their ability to replicate the crucial stages of neurodevelopment. In our studies using primary culture of cerebellar granule cells (CGCs) we have evaluated whether the gene expression relevant to the most critical developmental processes such as neuronal differentiation (NF-68 and NF-200) and functional maturation (NMDA and GABA A receptors), proliferation and differentiation of astrocytes (GFAP and S100β) as well as the presence of neural precursor cells (nestin and Sox10) could be used as an endpoint for in vitro DNT. The expression of these genes was assessed after exposure to various pesticides (paraquat parathion, dichlorvos, pentachlorophenol and cycloheximide) that could induce developmental neurotoxicity through different mechanisms. All studied pesticides significantly modified the expression of selected genes, related to the different stages of neuronal and/or glial cell development and maturation. The most significant changes were observed after exposure to paraquat and parathion (i.e. down-regulation of mRNA expression of NF-68 and NF-200, NMDA and GABA A receptors). Similarly, dichlorvos affected mainly neurons (decreased mRNA expression of NF-68 and GABA A receptors) whereas cycloheximide had an effect on neurons and astrocytes, as significant decreases in the mRNA expression of both neurofilaments (NF-68 and NF-200) and the astrocyte marker (S100β) were observed. Our results suggest that toxicity induced by pesticides that target multiple pathways of neurodevelopment can be identified by studying expression of genes that are involved in different stages of cell development and maturation, and that gene expression could be used as a sensitive endpoint for initial screening to identify the compounds with the potential to cause developmental neurotoxicity

  20. Bayesian model selection techniques as decision support for shaping a statistical analysis plan of a clinical trial: An example from a vertigo phase III study with longitudinal count data as primary endpoint

    Directory of Open Access Journals (Sweden)

    Adrion Christine

    2012-09-01

    Full Text Available Abstract Background A statistical analysis plan (SAP is a critical link between how a clinical trial is conducted and the clinical study report. To secure objective study results, regulatory bodies expect that the SAP will meet requirements in pre-specifying inferential analyses and other important statistical techniques. To write a good SAP for model-based sensitivity and ancillary analyses involves non-trivial decisions on and justification of many aspects of the chosen setting. In particular, trials with longitudinal count data as primary endpoints pose challenges for model choice and model validation. In the random effects setting, frequentist strategies for model assessment and model diagnosis are complex and not easily implemented and have several limitations. Therefore, it is of interest to explore Bayesian alternatives which provide the needed decision support to finalize a SAP. Methods We focus on generalized linear mixed models (GLMMs for the analysis of longitudinal count data. A series of distributions with over- and under-dispersion is considered. Additionally, the structure of the variance components is modified. We perform a simulation study to investigate the discriminatory power of Bayesian tools for model criticism in different scenarios derived from the model setting. We apply the findings to the data from an open clinical trial on vertigo attacks. These data are seen as pilot data for an ongoing phase III trial. To fit GLMMs we use a novel Bayesian computational approach based on integrated nested Laplace approximations (INLAs. The INLA methodology enables the direct computation of leave-one-out predictive distributions. These distributions are crucial for Bayesian model assessment. We evaluate competing GLMMs for longitudinal count data according to the deviance information criterion (DIC or probability integral transform (PIT, and by using proper scoring rules (e.g. the logarithmic score. Results The instruments under study

  1. Bayesian model selection techniques as decision support for shaping a statistical analysis plan of a clinical trial: an example from a vertigo phase III study with longitudinal count data as primary endpoint.

    Science.gov (United States)

    Adrion, Christine; Mansmann, Ulrich

    2012-09-10

    A statistical analysis plan (SAP) is a critical link between how a clinical trial is conducted and the clinical study report. To secure objective study results, regulatory bodies expect that the SAP will meet requirements in pre-specifying inferential analyses and other important statistical techniques. To write a good SAP for model-based sensitivity and ancillary analyses involves non-trivial decisions on and justification of many aspects of the chosen setting. In particular, trials with longitudinal count data as primary endpoints pose challenges for model choice and model validation. In the random effects setting, frequentist strategies for model assessment and model diagnosis are complex and not easily implemented and have several limitations. Therefore, it is of interest to explore Bayesian alternatives which provide the needed decision support to finalize a SAP. We focus on generalized linear mixed models (GLMMs) for the analysis of longitudinal count data. A series of distributions with over- and under-dispersion is considered. Additionally, the structure of the variance components is modified. We perform a simulation study to investigate the discriminatory power of Bayesian tools for model criticism in different scenarios derived from the model setting. We apply the findings to the data from an open clinical trial on vertigo attacks. These data are seen as pilot data for an ongoing phase III trial. To fit GLMMs we use a novel Bayesian computational approach based on integrated nested Laplace approximations (INLAs). The INLA methodology enables the direct computation of leave-one-out predictive distributions. These distributions are crucial for Bayesian model assessment. We evaluate competing GLMMs for longitudinal count data according to the deviance information criterion (DIC) or probability integral transform (PIT), and by using proper scoring rules (e.g. the logarithmic score). The instruments under study provide excellent tools for preparing decisions

  2. Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate® System: three- and six-month endpoint results from the FAST-EU study.

    Science.gov (United States)

    Bongers, Marlies; Brölmann, Hans; Gupta, Janesh; Garza-Leal, José Gerardo; Toub, David

    This was a prospective, longitudinal, multicenter, single-arm controlled trial, using independent core laboratory validation of MRI results, to establish the effectiveness and confirm the safety of the VizAblate® System in the treatment of symptomatic uterine fibroids. The VizAblate System is a transcervical device that ablates fibroids with radiofrequency energy, guided by a built-in intrauterine ultrasound probe. Fifty consecutive women with symptomatic uterine fibroids received treatment with the VizAblate System. Patients had a minimum Menstrual Pictogram score of 120, no desire for fertility, and met additional inclusion and exclusion criteria. The VizAblate System was inserted transcervically and individual fibroids were ablated with radiofrequency energy. An integrated intrauterine ultrasound probe was used for fibroid imaging and targeting. Anesthesia was at the discretion of each investigator. The primary study endpoint was the percentage change in perfused fibroid volume, as assessed by contrast-enhanced MRI at 3 months. Secondary endpoints, reached at 6 months, included safety, percentage reductions in the Menstrual Pictogram (MP) score and the Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom-Quality of Life questionnaire (UFS-QOL), along with the rate of surgical reintervention for abnormal uterine bleeding and the mean number of days to return to normal activity. Additional assessments included the Health-Related Quality of Life (HRQOL) subscale of the UFS-QOL, medical reintervention for abnormal uterine bleeding, and procedure times. Fifty patients were treated, representing 92 fibroids. Perfused fibroid volumes were reduced at 3 months by an average of 68.8 ± 27.8 % ( P  abnormal uterine bleeding associated with fibroids, with appropriate safety and a low reintervention rate.

  3. Radiotherapeutic results for primary lung cancer

    International Nuclear Information System (INIS)

    Mitomo, Osamu; Shinozaki, Jun; Suzuki, Yoshihiko; Niibe, Hideo; Mitsuhashi, Norio; Nakajima, Nobuaki.

    1988-01-01

    From June 1978 to March 1984, 311 patients with lung cancer were registered at the radiological department of National Takasaki Hospital. One hundred fifty-one of them, who had been verified histologically and irradiated with total doses of more than 60 Gy for the primary lung tumor, were analized. Many patients were more than 60 years old (82 %) and had squamous cell carcinoma (64 %). These percentages may be associated with distributions of patients treated by radiotherapy because of inoperability. The five-year-relative survival rate was 13 % in all patients (54 % for Stage I, 32 % for Stage II, 0 % for Stage III, 10 % for Stage IV). Comparing squamous cell carcinoma and adenocarcinoma, the latter had a better prognosis for two years, but over three years, squamous cell carcinoma did. The five-year survival rate was 10 % for squamous cell carcinoma and 6 % for adenocarcinoma, showing no statistically significant difference. No predominant differences of prognosis between the older group (more than 70 years old) and the younger group (less than 70 years old) was demonstrated. Thus, old age is not always a factor in bad prognosis. (author)

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

    Science.gov (United States)

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

    2003-07-01

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

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

    Science.gov (United States)

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

    2015-05-01

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

  6. Impact of initial platelet count on baseline angiographic finding and end-points in ST-elevation myocardial infarction referred for primary percutaneous coronary intervention.

    Science.gov (United States)

    Kaplan, Sahin; Kaplan, Safiye Tuba; Kiris, Abdulkadir; Gedikli, Omer

    2014-01-01

    The baseline platelet count (BPC) in patients with acute ST elevation myocardial infarction (STEMI) may reflect the baseline anjiografic finding and may also predic long-term outcomes after primary percutaneous coronary intervention (PPCI). Available data for the value of BPC in patients with STEMI treated with PPCI are still questionable. Therefore, we sought to determine the prognostic value of BPC for baseline angiographic finding and the impact of BPC on clinical outcomes of patients treating with PPCI. Blood sample for BPC was obtained on admission in 140 consecutive patients undergoing PPCI. Patients were divided 2 groups that group-1 (104 patients): TIMI flow-grade 0 and group-2 (36 patients): TIMI flow-grade 1-3. Follow-up was performed at 1-9 months. Baseline demographics were comparable, but, BPC was significantly higher in group-1 comparing 2 (293.7±59.8x10(9)/L vs. 237.7±50.9x10(9)/L, pmeasuring of a BPC on admission may also provide further practical and therapeutic profits.

  7. Evaluation of early efficacy endpoints for proof-of-concept trials.

    Science.gov (United States)

    Chen, Cong; Sun, Linda; Li, Chih-Lin

    2013-03-11

    A Phase II proof-of-concept (POC) trial usually uses an early efficacy endpoint other than a clinical endpoint as the primary endpoint. Because of the advancement in bioscience and technology, which has yielded a number of new surrogate biomarkers, drug developers often have more candidate endpoints to choose from than they can handle. As a result, selection of endpoint and its effect size as well as choice of type I/II error rates are often at the center of heated debates in design of POC trials. While optimization of the trade-off between benefit and cost is the implicit objective in such a decision-making process, it is seldom explicitly accounted for in practice. In this research note, motivated by real examples from the oncology field, we provide practical measures for evaluation of early efficacy endpoints (E4) for POC trials. We further provide optimal design strategies for POC trials that include optimal Go-No Go decision criteria for initiation of Phase III and optimal resource allocation strategies for conducting multiple POC trials in a portfolio under fixed resources. Although oncology is used for illustration purpose, the same idea developed in this research note also applies to similar situations in other therapeutic areas or in early-stage drug development in that a Go-No Go decision has to rely on limited data from an early efficacy endpoint and cost-effectiveness is the main concern.

  8. Cost-effectiveness of a mild compared with a standard strategy for IVF : a randomized comparison using cumulative term live birth as the primary endpoint

    NARCIS (Netherlands)

    Polinder, S.; Heijnen, E. M. E. W.; Macklon, N. S.; Habbema, J. D. F.; Fauser, B. J. C. M.; Eijkemans, M. J. C.

    Background: Conventional ovarian stimulation and the transfer of two embryos in IVF exhibits an inherent high probability of multiple pregnancies, resulting in high costs. We evaluated the cost-effectiveness of a mild compared with a conventional strategy for IVF. Methods: Four hundred and four

  9. Cost-effectiveness of a mild compared with a standard strategy for IVF: a randomized comparison using cumulative term live birth as the primary endpoint.

    Science.gov (United States)

    Polinder, S; Heijnen, E M E W; Macklon, N S; Habbema, J D F; Fauser, B J C M; Eijkemans, M J C

    2008-02-01

    BACKGROUND Conventional ovarian stimulation and the transfer of two embryos in IVF exhibits an inherent high probability of multiple pregnancies, resulting in high costs. We evaluated the cost-effectiveness of a mild compared with a conventional strategy for IVF. METHODS Four hundred and four patients were randomly assigned to undergo either mild ovarian stimulation/GnRH antagonist co-treatment combined with single embryo transfer, or standard stimulation/GnRH agonist long protocol and the transfer of two embryos. The main outcome measures are total costs of treatment within a 12 months period after randomization, and the relationship between total costs and proportion of cumulative pregnancies resulting in term live birth within 1 year of randomization. RESULTS Despite a significantly increased average number of IVF cycles (2.3 versus 1.7; P costs over a 12-month period (8333 versus euro10 745; P = 0.006) were observed using the mild strategy. This was mainly due to higher costs of the obstetric and post-natal period for the standard strategy, related to multiple pregnancies. The costs per pregnancy leading to term live birth were euro19 156 in the mild strategy and euro24 038 in the standard. The incremental cost-effectiveness ratio of the standard strategy compared with the mild strategy was euro185 000 per extra pregnancy leading to term live birth. CONCLUSIONS Despite an increased mean number of IVF cycles within 1 year, from an economic perspective, the mild treatment strategy is more advantageous per term live birth. It is unlikely, over a wide range of society's willingness-to-pay, that the standard treatment strategy is cost-effective, compared with the mild strategy.

  10. Urethral carcinoma in women: results of treatment with primary radiotherapy

    International Nuclear Information System (INIS)

    Milosevic, M.F.; Wards, P.R.; Gospodarowicz, M.K.; McLean, M.; Catton, P.A.; Catton, C.N.; Banerjee, D.

    2000-01-01

    Urethral carcinoma in women is uncommon. This study was undertaken to evaluate the role of radiotherapy in the treatment of these tumors. The hospital records of 34 women with primary urethral carcinoma were retrospectively reviewed. There were 15 squamous cell carcinomas, 13 transitional cell carcinomas, and six adenocarcinomas. The primary tumor was >4 cm in size in eight patients, involved the proximal urethra in 19 and extended to adjacent organs in 22. Inguinal or iliac lymphadenopathy was present in nine patients. There were eight TNM stage I/II tumors, 11 stage III tumors and 15 stage IV tumors. Radiotherapy was administered only to the primary tumor in 15 patients, and to the primary tumor and regional lymph nodes in the remaining 19 patients. Brachytherapy with or without external radiation was used to treat the primary tumor in 20 patients. Tumor recurred in 21 patients. The 7-year actuarial overall and cause-specific survivals were 41 and 45%, respectively. Large primary tumor bulk and treatment with external beam radiation alone (no brachytherapy) were independent adverse prognostic factors for local tumor recurrence. Brachytherapy reduced the risk of local recurrence by a factor of 4.2. The beneficial effect of brachytherapy was most prominently seen in patients with bulky primary disease. Large tumor size was the only independent adverse predictor of overall disease recurrence and death from cancer. Radiotherapy is an effective treatment for carcinoma of the female urethra and preserves normal anatomy and function. Brachytherapy improves local tumor control, possibly as a result of the higher radiation dose that can safely be delivered. (author)

  11. Shared Contract-Obedient Endpoints

    Directory of Open Access Journals (Sweden)

    Étienne Lozes

    2012-12-01

    Full Text Available Most of the existing verification techniques for message-passing programs suppose either that channel endpoints are used in a linear fashion, where at most one thread may send or receive from an endpoint at any given time, or that endpoints may be used arbitrarily by any number of threads. The former approach usually forbids the sharing of channels while the latter limits what is provable about programs. In this paper we propose a midpoint between these techniques by extending a proof system based on separation logic to allow sharing of endpoints. We identify two independent mechanisms for supporting sharing: an extension of fractional shares to endpoints, and a new technique based on what we call reflexive ownership transfer. We demonstrate on a number of examples that a linear treatment of sharing is possible.

  12. African Primary Care Research: Quantitative analysis and presentation of results

    Science.gov (United States)

    Ogunbanjo, Gboyega A.

    2014-01-01

    Abstract This article is part of a series on Primary Care Research Methods. The article describes types of continuous and categorical data, how to capture data in a spreadsheet, how to use descriptive and inferential statistics and, finally, gives advice on how to present the results in text, figures and tables. The article intends to help Master's level students with writing the data analysis section of their research proposal and presenting their results in their final research report. PMID:26245435

  13. Results of radiotherapy for primary subglottic squamous cell carcinoma

    International Nuclear Information System (INIS)

    Paisley, Sonya; Warde, Padraig R.; O'Sullivan, Brian; Waldron, John; Gullane, Patrick J.; Payne, David; Liu, F.-F.; Bayley, Andrew; Ringash, Jolie; Cummings, Bernard J.

    2002-01-01

    Purpose: To retrospectively evaluate the outcome after radical radiotherapy (RT) and surgical salvage and assess the risk of late toxicity for patients with primary subglottic squamous cell carcinoma treated at our center. Methods and Materials: Between 1971 and 1996, 43 patients with primary squamous cell carcinoma of the subglottis (35 men, 8 women) were treated with radical RT. All received megavoltage irradiation, most commonly to a dose of 50-52 Gy in 20 fractions during 4 weeks (39 patients). The median follow-up was 4.2 years. Results: Local control was achieved with RT alone in 24 (56%) of the 43 patients: 7 of 11 with T1, 8 of 12 with T2, 4 of 8 with T3, and 5 of 12 with T4. The 5-year actuarial local relapse-free rate was 52%. Subsequent local control was achieved in 11 of the 13 patients with failed RT and attempted surgical salvage, for an ultimate local control rate of 81.4% (35 of 43). The 5-year overall and cause-specific actuarial survival rate was 50.3% and 66.9%, respectively. No patients developed Grade 3 or 4 late radiation morbidity. Conclusion: These data support the use of primary RT in the treatment of patients with primary squamous cell carcinoma of the subglottis as an appropriate treatment approach providing an option for laryngeal conservation

  14. The intermediate endpoint effect in logistic and probit regression

    Science.gov (United States)

    MacKinnon, DP; Lockwood, CM; Brown, CH; Wang, W; Hoffman, JM

    2010-01-01

    Background An intermediate endpoint is hypothesized to be in the middle of the causal sequence relating an independent variable to a dependent variable. The intermediate variable is also called a surrogate or mediating variable and the corresponding effect is called the mediated, surrogate endpoint, or intermediate endpoint effect. Clinical studies are often designed to change an intermediate or surrogate endpoint and through this intermediate change influence the ultimate endpoint. In many intermediate endpoint clinical studies the dependent variable is binary, and logistic or probit regression is used. Purpose The purpose of this study is to describe a limitation of a widely used approach to assessing intermediate endpoint effects and to propose an alternative method, based on products of coefficients, that yields more accurate results. Methods The intermediate endpoint model for a binary outcome is described for a true binary outcome and for a dichotomization of a latent continuous outcome. Plots of true values and a simulation study are used to evaluate the different methods. Results Distorted estimates of the intermediate endpoint effect and incorrect conclusions can result from the application of widely used methods to assess the intermediate endpoint effect. The same problem occurs for the proportion of an effect explained by an intermediate endpoint, which has been suggested as a useful measure for identifying intermediate endpoints. A solution to this problem is given based on the relationship between latent variable modeling and logistic or probit regression. Limitations More complicated intermediate variable models are not addressed in the study, although the methods described in the article can be extended to these more complicated models. Conclusions Researchers are encouraged to use an intermediate endpoint method based on the product of regression coefficients. A common method based on difference in coefficient methods can lead to distorted

  15. Patients’ preferences for selection of endpoints in cardiovascular clinical trials

    Directory of Open Access Journals (Sweden)

    Robert D. Chow

    2014-02-01

    Full Text Available Background: To reduce the duration and overall costs of cardiovascular trials, use of the combined endpoints in trial design has become commonplace. Though this methodology may serve the needs of investigators and trial sponsors, the preferences of patients or potential trial subjects in the trial design process has not been studied. Objective: To determine the preferences of patients in the design of cardiovascular trials. Design: Participants were surveyed in a pilot study regarding preferences among various single endpoints commonly used in cardiovascular trials, preference for single vs. composite endpoints, and the likelihood of compliance with a heart medication if patients similar to them participated in the trial design process. Participants: One hundred adult English-speaking patients, 38% male, from a primary care ambulatory practice located in an urban setting. Key results: Among single endpoints, participants rated heart attack as significantly more important than death from other causes (4.53 vs. 3.69, p=0.004 on a scale of 1–6. Death from heart disease was rated as significantly more important than chest pain (4.73 vs. 2.47, p<0.001, angioplasty/PCI/CABG (4.73 vs. 2.43, p<0.001, and stroke (4.73 vs. 2.43, p<0.001. Participants also expressed a slight preference for combined endpoints over single endpoint (43% vs. 57%, incorporation of the opinions of the study patient population into the design of trials (48% vs. 41% for researchers, and a greater likelihood of medication compliance if patient preferences were considered during trial design (67% indicated a significant to major effect. Conclusions: Patients are able to make judgments and express preferences regarding trial design. They prefer that the opinions of the study population rather than the general population be incorporated into the design of the study. This novel approach to study design would not only incorporate patient preferences into medical decision making, but

  16. Job satisfaction among primary care physicians: results of a survey.

    Science.gov (United States)

    Behmann, Mareike; Schmiemann, Guido; Lingner, Heidrun; Kühne, Franziska; Hummers-Pradier, Eva; Schneider, Nils

    2012-03-01

    A shortage of primary care physicians (PCPs) seems likely in Germany in the near future and already exists in some parts of the country. Many currently practicing PCPs will soon reach retirement age, and recruiting young physicians for family practice is difficult. The attractiveness of primary care for young physicians depends on the job satisfaction of currently practicing PCPs. We studied job satisfaction among PCPs in Lower Saxony, a large federal state in Germany. In 2009, we sent a standardized written questionnaire on overall job satisfaction and on particular aspects of medical practice to 3296 randomly chosen PCPs and internists in family practice in Lower Saxony (50% of the entire target population). 1106 physicians (34%) responded; their mean age was 52, and 69% were men. 64% said they were satisfied or very satisfied with their job overall. There were particularly high rates of satisfaction with patient contact (91%) and working atmosphere (87% satisfied or very satisfied). In contrast, there were high rates of dissatisfaction with administrative tasks (75% dissatisfied or not at all satisfied). The results were more indifferent concerning payment and work life balance. Overall, younger PCPs and physicians just entering practice were more satisfied than their older colleagues who had been in practice longer. PCPs are satisfied with their job overall. However, there is significant dissatisfaction with administrative tasks. Improvements in this area may contribute to making primary care more attractive to young physicians.

  17. Results of primary radiation therapy in early vocal cord cancers

    International Nuclear Information System (INIS)

    Mehta, S.A.; Sarkar, S.; Mehta, M.S.; Marfatia, P.T.; Choudhary, A.J.; Mehta, A.R.

    1991-01-01

    Results of 74 patients treated by primary radiation therapy with curative intent at the Tata Memorial Hospital between January 1980 and December 1984 are reported. Thirty three (44.6%) were classified as TlaNO, twenty five (33.8%) as TlbNO, ten (13.5%) as T2NO and six(8.1%) as TisNO. The 5-year actuarial survival was 92% and disease-free survival was 85%. Thirteen patients (17.5%) failed locally, seven (53.8%) of whom were salvaged by surgery. Radiation side-effects were minimal and there were no long term complications. Anterior commissure involvement did not affect the local recurrence rates. (author). 19 refs., 1 tabs

  18. Sample size determination in clinical trials with multiple endpoints

    CERN Document Server

    Sozu, Takashi; Hamasaki, Toshimitsu; Evans, Scott R

    2015-01-01

    This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as multiple primary or co-primary, offering an important reference work for statisticians working in this area. The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clin...

  19. Gemcitabine and irinotecan as first-line therapy for carcinoma of unknown primary: results of a multicenter phase II trial.

    Directory of Open Access Journals (Sweden)

    Shernan G Holtan

    Full Text Available Metastatic carcinoma of unknown primary (CUP has a very poor prognosis, and no standard first-line therapy currently exists. Here, we report the results of a phase II study utilizing a combination of gemcitabine and irinotecan as first-line therapy. Treatment was with gemcitabine 1000 mg/m(2 and irinotecan 75 mg/m(2 weekly times four on a six week cycle (Cohort I. Due to excessive toxicity, the dose and schedule were modified as follows: gemcitabine 750 mg/m(2 and irinotecan 75 mg/m(2 given weekly times three on a four week cycle (Cohort II. The primary endpoint was the confirmed response rate (CR + PR. Secondary endpoints consisted of adverse events based upon the presence or absence of the UDP glucuronosyltransferase 1 family, polypeptide A1*28 (UGT1A1*28 polymorphism, time to progression, and overall survival. Thirty-one patients were enrolled with a median age of 63 (range: 38-94, and 26 patients were evaluable for efficacy. Significant toxicity was observed in Cohort 1, characterized by 50% (7/14 patients experiencing a grade 4+ adverse event, but not in cohort II. The confirmed response rate including patients from both cohorts was 12% (95% CI: 2-30%, which did not meet the criteria for continued enrollment. Overall median survival was 7.2 months (95% CI: 4.0 to 11.6 for the entire cohort but notably longer in cohort II than in cohort I (9.3 months (95% CI: 4.1 to 12.1 versus 4.0 months (95% CI: 2.2 to 15.6. Gemcitabine and irinotecan is not an active combination when used as first line therapy in patients with metastatic carcinoma of unknown primary. Efforts into developing novel diagnostic and therapeutic approaches remain important for improving the outlook for this heterogeneous group of patients.ClinicalTrials.gov NCT00066781.

  20. Predictive modelling for swallowing dysfunction after primary (chemo)radiation: results of a prospective observational study.

    Science.gov (United States)

    Christianen, Miranda E M C; Schilstra, Cornelis; Beetz, Ivo; Muijs, Christina T; Chouvalova, Olga; Burlage, Fred R; Doornaert, Patricia; Koken, Phil W; Leemans, C René; Rinkel, Rico N P M; de Bruijn, Marieke J; de Bock, G H; Roodenburg, Jan L N; van der Laan, Bernard F A M; Slotman, Ben J; Verdonck-de Leeuw, Irma M; Bijl, Hendrik P; Langendijk, Johannes A

    2012-10-01

    The purpose of this large multicentre prospective cohort study was to identify which dose volume histogram parameters and pre-treatment factors are most important to predict physician-rated and patient-rated radiation-induced swallowing dysfunction (RISD) in order to develop predictive models for RISD after curative (chemo) radiotherapy ((CH) RT). The study population consisted of 354 consecutive head and neck cancer patients treated with (CH) RT. The primary endpoint was grade 2 or more swallowing dysfunction according to the RTOG/EORTC late radiation morbidity scoring criteria at 6 months after (CH) RT. The secondary endpoints were patient-rated swallowing complaints as assessed with the EORTC QLQ-H&N35 questionnaire. To select the most predictive variables a multivariate logistic regression analysis with bootstrapping was used. At 6 months after (CH) RT the bootstrapping procedure revealed that a model based on the mean dose to the superior pharyngeal constrictor muscle (PCM) and mean dose to the supraglottic larynx was most predictive. For the secondary endpoints different predictive models were found: for problems with swallowing liquids the most predictive factors were the mean dose to the supraglottic larynx and radiation technique (3D-CRT versus IMRT). For problems with swallowing soft food the mean dose to the middle PCM, age (18-65 versus >65 years), tumour site (naso/oropharynx versus other sites) and radiation technique (3D-CRT versus IMRT) were the most predictive factors. For problems with swallowing solid food the most predictive factors were the mean dose to the superior PCM, the mean dose to the supraglottic larynx and age (18-65 versus >65 years). And for choking when swallowing the V60 of the oesophageal inlet muscle and the mean dose to the supraglottic larynx were the most predictive factors. Physician-rated and patient-rated RISD in head and neck cancer patients treated with (CH) RT cannot be predicted with univariate relationships between the

  1. Adhesion kinetics of human primary monocytes, dendritic cells, and macrophages: Dynamic cell adhesion measurements with a label-free optical biosensor and their comparison with end-point assays.

    Science.gov (United States)

    Orgovan, Norbert; Ungai-Salánki, Rita; Lukácsi, Szilvia; Sándor, Noémi; Bajtay, Zsuzsa; Erdei, Anna; Szabó, Bálint; Horvath, Robert

    2016-09-01

    Monocytes, dendritic cells (DCs), and macrophages (MFs) are closely related immune cells that differ in their main functions. These specific functions are, to a considerable degree, determined by the differences in the adhesion behavior of the cells. To study the inherently and essentially dynamic aspects of the adhesion of monocytes, DCs, and MFs, dynamic cell adhesion assays were performed with a high-throughput label-free optical biosensor [Epic BenchTop (BT)] on surfaces coated with either fibrinogen (Fgn) or the biomimetic copolymer PLL-g-PEG-RGD. Cell adhesion profiles typically reached their maximum at ∼60 min after cell seeding, which was followed by a monotonic signal decrease, indicating gradually weakening cell adhesion. According to the biosensor response, cell types could be ordered by increasing adherence as monocytes, MFs, and DCs. Notably, all three cell types induced a larger biosensor signal on Fgn than on PLL-g-PEG-RGD. To interpret this result, the molecular layers were characterized by further exploiting the potentials of the biosensor: by measuring the adsorption signal induced during the surface coating procedure, the authors could estimate the surface density of adsorbed molecules and, thus, the number of binding sites potentially presented for the adhesion receptors. Surfaces coated with PLL-g-PEG-RGD presented less RGD sites, but was less efficient in promoting cell spreading than those coated with Fgn; hence, other binding sites in Fgn played a more decisive role in determining cell adherence. To support the cell adhesion data obtained with the biosensor, cell adherence on Fgn-coated surfaces 30-60 min after cell seeding was measured with three complementary techniques, i.e., with (1) a fluorescence-based classical adherence assay, (2) a shear flow chamber applying hydrodynamic shear stress to wash cells away, and (3) an automated micropipette using vacuum-generated fluid flow to lift cells up. These techniques confirmed the results

  2. Improved Endpoints for Cancer Immunotherapy Trials

    Science.gov (United States)

    Eggermont, Alexander M. M.; Janetzki, Sylvia; Hodi, F. Stephen; Ibrahim, Ramy; Anderson, Aparna; Humphrey, Rachel; Blumenstein, Brent; Wolchok, Jedd

    2010-01-01

    Unlike chemotherapy, which acts directly on the tumor, cancer immunotherapies exert their effects on the immune system and demonstrate new kinetics that involve building a cellular immune response, followed by changes in tumor burden or patient survival. Thus, adequate design and evaluation of some immunotherapy clinical trials require a new development paradigm that includes reconsideration of established endpoints. Between 2004 and 2009, several initiatives facilitated by the Cancer Immunotherapy Consortium of the Cancer Research Institute and partner organizations systematically evaluated an immunotherapy-focused clinical development paradigm and created the principles for redefining trial endpoints. On this basis, a body of clinical and laboratory data was generated that supports three novel endpoint recommendations. First, cellular immune response assays generate highly variable results. Assay harmonization in multicenter trials may minimize variability and help to establish cellular immune response as a reproducible biomarker, thus allowing investigation of its relationship with clinical outcomes. Second, immunotherapy may induce novel patterns of antitumor response not captured by Response Evaluation Criteria in Solid Tumors or World Health Organization criteria. New immune-related response criteria were defined to more comprehensively capture all response patterns. Third, delayed separation of Kaplan–Meier curves in randomized immunotherapy trials can affect results. Altered statistical models describing hazard ratios as a function of time and recognizing differences before and after separation of curves may allow improved planning of phase III trials. These recommendations may improve our tools for cancer immunotherapy trials and may offer a more realistic and useful model for clinical investigation. PMID:20826737

  3. Establishing a group of endpoints to support collective operations without specifying unique identifiers for any endpoints

    Science.gov (United States)

    Archer, Charles J.; Blocksom, Michael A.; Ratterman, Joseph D.; Smith, Brian E.; Xue, Hanghon

    2016-02-02

    A parallel computer executes a number of tasks, each task includes a number of endpoints and the endpoints are configured to support collective operations. In such a parallel computer, establishing a group of endpoints receiving a user specification of a set of endpoints included in a global collection of endpoints, where the user specification defines the set in accordance with a predefined virtual representation of the endpoints, the predefined virtual representation is a data structure setting forth an organization of tasks and endpoints included in the global collection of endpoints and the user specification defines the set of endpoints without a user specification of a particular endpoint; and defining a group of endpoints in dependence upon the predefined virtual representation of the endpoints and the user specification.

  4. Helicopter EMS: Research Endpoints and Potential Benefits

    Directory of Open Access Journals (Sweden)

    Stephen H. Thomas

    2012-01-01

    Full Text Available Patients, EMS systems, and healthcare regions benefit from Helicopter EMS (HEMS utilization. This article discusses these benefits in terms of specific endpoints utilized in research projects. The endpoint of interest, be it primary, secondary, or surrogate, is important to understand in the deployment of HEMS resources or in planning further HEMS outcomes research. The most important outcomes are those which show potential benefits to the patients, such as functional survival, pain relief, and earlier ALS care. Case reports are also important “outcomes” publications. The benefits of HEMS in the rural setting is the ability to provide timely access to Level I or Level II trauma centers and in nontrauma, interfacility transport of cardiac, stroke, and even sepsis patients. Many HEMS crews have pharmacologic and procedural capabilities that bring a different level of care to a trauma scene or small referring hospital, especially in the rural setting. Regional healthcare and EMS system's benefit from HEMS by their capability to extend the advanced level of care throughout a region, provide a “backup” for areas with limited ALS coverage, minimize transport times, make available direct transport to specialized centers, and offer flexibility of transport in overloaded hospital systems.

  5. African Primary Care Research: qualitative data analysis and writing results.

    Science.gov (United States)

    Mabuza, Langalibalele H; Govender, Indiran; Ogunbanjo, Gboyega A; Mash, Bob

    2014-06-05

    This article is part of a series on African primary care research and gives practical guidance on qualitative data analysis and the presentation of qualitative findings. After an overview of qualitative methods and analytical approaches, the article focuses particularly on content analysis, using the framework method as an example. The steps of familiarisation, creating a thematic index, indexing, charting, interpretation and confirmation are described. Key concepts with regard to establishing the quality and trustworthiness of data analysis are described. Finally, an approach to the presentation of qualitative findings is given.

  6. Radon in Irish primary and post-primary schools. The results of a national survey

    International Nuclear Information System (INIS)

    Synnott, H.; Fennell, S.; Pollard, D.; Colgan, P.A.; Hanley, O.; O'Colmain, M.; Maloney, L.

    2004-05-01

    This report presents the results of a survey of radon concentrations in schools in the Republic of Ireland. The survey was carried out by the Radiological Protection Institute of Ireland (RPII) on behalf of the Department of Education and Science. A workplace Reference Level of 400 Bq/m3 is set down in national legislation. However, in the case of schools the RPII has recommended that, wherever possible, radon concentrations should be reduced to below 200 Bq/m3. The objective of the survey was to assess the distribution of radon in Irish schools and to identify those requiring remedial work to reduce radon exposure to children and staff. The survey was carried out on a phased basis from 1998 to 2002. All schools in the Free Education System were invited to participate. Indoor radon concentrations were measured using passive alpha track-etch detectors with a measurement period of one academic year from September to the following June. Measurements were completed in the ground floor classrooms and offices of 3444 schools, representing over 85% of the approximate 4000 primary and post-primary schools in Ireland. Of these, 898 had radon concentrations greater than 200 Bq/m3 and 307 had radon concentrations in excess of the national Reference Level for workplaces of 400 Bq/m3 in one or more ground floor rooms. The average radon concentration in the schools surveyed was 93 Bq/m3. Different remediation strategies have been adopted for schools with maximum radon concentrations between 200 and 400 Bq/m3 and for schools with radon concentrations in excess of 400 Bq/m3. In schools with radon concentrations below 400 Bq/m3, passive remediation through increased background ventilation is, where practicable, being used to reduce the radon concentrations. Where the initial radon concentration exceeded 400 Bq/m3, a remediation consultant assessed the school and remedial measures specific to each school have been designed. In the majority of these cases active remediation in the

  7. Results from bonding of the SALT primary mirror edge sensors

    Science.gov (United States)

    Strydom, Ockert J.; Love, Jonathan; Gajjar, Hitesh

    2016-07-01

    The Southern African Large Telescope has till recently operated without active closed loop control of its Primary Mirror. The reason for this was that there were no suitable edge sensor system available on the market. Recently a system became available and SALT form Fogale Nanotech. The system consist of a sensor, cables and control electronics. The system was still under development and SALT was responsible for the integration of the sensors before deployment on the Telescope. Several issues still had to be addressed. One of these issues was the integration of the sensors at an appropriate production rate. The sensors was supplied as flexible pc boards with different types making up the transmitters and receivers. These flexible boards were bonded to ClearCeram Z L-Brackets before the appropriate connectors were installed. This paper describes the process used to integrate and test the sensors.

  8. Protocol of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project: formal consensus method for the development of guidelines for standardised time-to-event endpoints' definitions in cancer clinical trials.

    Science.gov (United States)

    Bellera, Carine A; Pulido, Marina; Gourgou, Sophie; Collette, Laurence; Doussau, Adélaïde; Kramar, Andrew; Dabakuyo, Tienhan Sandrine; Ouali, Monia; Auperin, Anne; Filleron, Thomas; Fortpied, Catherine; Le Tourneau, Christophe; Paoletti, Xavier; Mauer, Murielle; Mathoulin-Pélissier, Simone; Bonnetain, Franck

    2013-03-01

    In randomised phase III cancer clinical trials, the most objectively defined and only validated time-to-event endpoint is overall survival (OS). The appearance of new types of treatments and the multiplication of lines of treatment have resulted in the use of surrogate endpoints for overall survival such as progression-free survival (PFS), or time-to-treatment failure. Their development is strongly influenced by the necessity of reducing clinical trial duration, cost and number of patients. However, while these endpoints are frequently used, they are often poorly defined and definitions can differ between trials which may limit their use as primary endpoints. Moreover, this variability of definitions can impact on the trial's results by affecting estimation of treatments' effects. The aim of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project is to provide recommendations for standardised definitions of time-to-event endpoints in randomised cancer clinical trials. We will use a formal consensus methodology based on experts' opinions which will be obtained in a systematic manner. Definitions will be independently developed for several cancer sites, including pancreatic, breast, head and neck and colon cancer, as well as sarcomas and gastrointestinal stromal tumours (GISTs). The DATECAN project should lead to the elaboration of recommendations that can then be used as guidelines by researchers participating in clinical trials. This process should lead to a standardisation of the definitions of commonly used time-to-event endpoints, enabling appropriate comparisons of future trials' results. Copyright © 2012 Elsevier Ltd. All rights reserved.

  9. Radiological endpoints relevant to ecological risk assessment

    International Nuclear Information System (INIS)

    Harrison, F.

    1997-01-01

    Because of the potential risk from radiation due to the releases of radionuclides from anthropogenic activities, considerable research was performed to determine for humans the levels of dose received, their responses to the doses and mechanisms of action of radioactivity on living matter. More recently, there is an increased interest in the effects of radioactivity on non-human species. There are differences in approach between risk assessment for humans and ecosystems. For protection of humans, the focus is the individual and the endpoint of primary concern is cancer induction. For protection of ecosystems, the focus is on population stability and the endpoint of concern is reproductive success for organisms important ecologically and economically. For these organisms, information is needed on their responses to irradiation and the potential impact of the doses absorbed on their reproductive success. Considerable information is available on the effects of radiation on organisms from different phyla and types of ecosystems. Databases useful for assessing risk from exposures of populations to radioactivity are the effects of irradiation on mortality, fertility and sterility, the latter two of which are important components of reproductive success. Data on radiation effects on mortality are available both from acute and chronic irradiation. In relation to radiation effects, reproductive success for a given population is related to a number of characteristics of the species, including inherent radiosensitivity of reproductive tissues and early life stages, processes occurring during gametogenesis, reproductive strategy and exposure history. The available data on acute and chronic radiation doses is reviewed for invertebrates, fishes and mammals. The information reviewed indicates that wide ranges in responses with species can be expected. Parameters that most likely contribute to inherent radiosensitivity are discussed. (author)

  10. Imaging screening of breast cancer: primary results in 5307 cases

    International Nuclear Information System (INIS)

    Xiao Qin; Zheng Xiaojing; Wang Xiaohong; Liu Quan; Jiang Chaoxia; Xu Linghui; Peng Weijun; Hu Danting; Wang Yufang; Gu Yajia; Liu Guangyu; Shao Zhimin; Shen Kunwei; Chang Cai; Han Chao

    2008-01-01

    Objective: To discuss the values of three screening methods for the detection of early breast cancer, and to analyze the features of the screening cancer. Methods: The first screening of breast cancer were performed in 5307 women who aged from 20 to 76 years with median age of 49 years. The three screening methods included physical examination with ultrasound and mammography, physical examination with mammography and mammography only. The rate of recall, biopsy, cancer detection of three methods were analyzed and the mammographic findings were reviewed. Chi-square test or Fisher's exact test were used for the statistics. Results: The recall rates were 4.90% (49/1001), 6.90% (166/2407) and 4. 48% (85/1899) in three methods respectively, the biopsy rates were 1.60% (16/1001), 1.04% (25/2407) and 0.63% (12/1899), the cancer detection rates were 0.50% (5/1001), 0.17% (4/2407) and 0 (0/1899). There were statistical differences among the three groups (χ 2 =12.99,6.264,8.764, P<0.05). Physical examination with ultrasound and mammography had the highest cancer detection rate, ten breast cancers were detected and 8 were early stage breast cancer. Of seven cancers detected by mammography, only two were found by ultrasound. A cluster of calcifications were found in 2 cases, linear calcifications in 2 cases. One case presented as a asymmetric density, one as a asymmetric density with calcifications, one as multiple nodules with a cluster of calcifications. Two breast cancers presented as asymmetric density were missed on mammography and diagnosed correctly after retrospective review. Conclusion: Physical examination with ultrasound and mammography is the best method for breast cancer screening. The breast cancer can be detected by mammography earlier than other methods. (authors)

  11. Root length of aquatic plant, Lemna minor L., as an optimal toxicity endpoint for biomonitoring of mining effluents.

    Science.gov (United States)

    Gopalapillai, Yamini; Vigneault, Bernard; Hale, Beverley A

    2014-10-01

    Lemna minor, a free-floating macrophyte, is used for biomonitoring of mine effluent quality under the Metal Mining Effluent Regulations (MMER) of the Environmental Effects Monitoring (EEM) program in Canada and is known to be sensitive to trace metals commonly discharged in mine effluents such as Ni. Environment Canada's standard toxicity testing protocol recommends frond count (FC) and dry weight (DW) as the 2 required toxicity endpoints-this is similar to other major protocols such as those by the US Environmental Protection Agency (USEPA) and the Organisation for Economic Co-operation and Development (OECD)-that both require frond growth or biomass endpoints. However, we suggest that similar to terrestrial plants, average root length (RL) of aquatic plants will be an optimal and relevant endpoint. As expected, results demonstrate that RL is the ideal endpoint based on the 3 criteria: accuracy (i.e., toxicological sensitivity to contaminant), precision (i.e., lowest variance), and ecological relevance (metal mining effluents). Roots are known to play a major role in nutrient uptake in conditions of low nutrient conditions-thus having ecological relevance to freshwater from mining regions. Root length was the most sensitive and precise endpoint in this study where water chemistry varied greatly (pH and varying concentrations of Ca, Mg, Na, K, dissolved organic carbon, and an anthropogenic organic contaminant, sodium isopropyl xanthates) to match mining effluent ranges. Although frond count was a close second, dry weight proved to be an unreliable endpoint. We conclude that toxicity testing for the floating macrophyte should require average RL measurement as a primary endpoint. © 2014 SETAC.

  12. Surrogate endpoints for overall survival in digestive oncology trials: which candidates? A questionnaires survey among clinicians and methodologists

    Directory of Open Access Journals (Sweden)

    Bonnetain Franck

    2010-06-01

    , were ranked first, with a frequency of more than 69% in 20 out of 22 settings. PFS was proposed in association with QoL in metastatic primary liver and stomach cancers (both 81%. This composite endpoint was ranked second in metastatic oesophageal (69%, colorectal (56% and anal (56% cancers, whereas QoL alone was also suggested in most metastatic situations. Other endpoints frequently suggested were R0 resection in the neoadjuvant settings (oesophagus (69%, stomach (56%, pancreas (75% and biliary tract (63% and response. An unexpected endpoint was metastatic PFS in non operable oesophageal (31% and pancreatic (44% cancers. Quality and results of surgical procedures like sphincter preservation were also cited as eligible surrogate endpoints in rectal (19% and anal (50% in case of localized disease cancers. Except for alpha-FP kinetic in hepatocellular carcinoma (13% and CA19-9 decline (6% in pancreas, few endpoints based on biological or tumour markers were proposed. Conclusion The overall results should help prioritise the endpoints to be statistically evaluated as surrogate for OS, so that trialists and clinicians can rely on endpoints that ensure relevant clinical benefit to the patient.

  13. Surrogate endpoints for overall survival in digestive oncology trials: which candidates? A questionnaires survey among clinicians and methodologists

    International Nuclear Information System (INIS)

    Methy, Nicolas; Bedenne, Laurent; Bonnetain, Franck

    2010-01-01

    69% in 20 out of 22 settings. PFS was proposed in association with QoL in metastatic primary liver and stomach cancers (both 81%). This composite endpoint was ranked second in metastatic oesophageal (69%), colorectal (56%) and anal (56%) cancers, whereas QoL alone was also suggested in most metastatic situations. Other endpoints frequently suggested were R0 resection in the neoadjuvant settings (oesophagus (69%), stomach (56%), pancreas (75%) and biliary tract (63%)) and response. An unexpected endpoint was metastatic PFS in non operable oesophageal (31%) and pancreatic (44%) cancers. Quality and results of surgical procedures like sphincter preservation were also cited as eligible surrogate endpoints in rectal (19%) and anal (50% in case of localized disease) cancers. Except for alpha-FP kinetic in hepatocellular carcinoma (13%) and CA19-9 decline (6%) in pancreas, few endpoints based on biological or tumour markers were proposed. The overall results should help prioritise the endpoints to be statistically evaluated as surrogate for OS, so that trialists and clinicians can rely on endpoints that ensure relevant clinical benefit to the patient

  14. Surrogate endpoints for overall survival in digestive oncology trials: which candidates? A questionnaires survey among clinicians and methodologists.

    Science.gov (United States)

    Methy, Nicolas; Bedenne, Laurent; Bonnetain, Franck

    2010-06-10

    % in 20 out of 22 settings. PFS was proposed in association with QoL in metastatic primary liver and stomach cancers (both 81%). This composite endpoint was ranked second in metastatic oesophageal (69%), colorectal (56%) and anal (56%) cancers, whereas QoL alone was also suggested in most metastatic situations.Other endpoints frequently suggested were R0 resection in the neoadjuvant settings (oesophagus (69%), stomach (56%), pancreas (75%) and biliary tract (63%)) and response. An unexpected endpoint was metastatic PFS in non operable oesophageal (31%) and pancreatic (44%) cancers. Quality and results of surgical procedures like sphincter preservation were also cited as eligible surrogate endpoints in rectal (19%) and anal (50% in case of localized disease) cancers. Except for alpha-FP kinetic in hepatocellular carcinoma (13%) and CA19-9 decline (6%) in pancreas, few endpoints based on biological or tumour markers were proposed. The overall results should help prioritise the endpoints to be statistically evaluated as surrogate for OS, so that trialists and clinicians can rely on endpoints that ensure relevant clinical benefit to the patient.

  15. Interim results: fines recycle testing using the 4-inch diameter primary graphite burner

    International Nuclear Information System (INIS)

    Palmer, W.B.

    1975-05-01

    The results of twenty-two HTGR primary burner runs in which graphite fines were recycled pneumatically to the 4-inch diameter pilot-plant primary fluidized-bed burner are described. The result of the tests showed that zero fines accumulation can easily be achieved while operating at plant equivalent burn rates. (U.S.)

  16. Surrogate Endpoint Evaluation: Principal Stratification Criteria and the Prentice Definition.

    Science.gov (United States)

    Gilbert, Peter B; Gabriel, Erin E; Huang, Ying; Chan, Ivan S F

    2015-09-01

    A common problem of interest within a randomized clinical trial is the evaluation of an inexpensive response endpoint as a valid surrogate endpoint for a clinical endpoint, where a chief purpose of a valid surrogate is to provide a way to make correct inferences on clinical treatment effects in future studies without needing to collect the clinical endpoint data. Within the principal stratification framework for addressing this problem based on data from a single randomized clinical efficacy trial, a variety of definitions and criteria for a good surrogate endpoint have been proposed, all based on or closely related to the "principal effects" or "causal effect predictiveness (CEP)" surface. We discuss CEP-based criteria for a useful surrogate endpoint, including (1) the meaning and relative importance of proposed criteria including average causal necessity (ACN), average causal sufficiency (ACS), and large clinical effect modification; (2) the relationship between these criteria and the Prentice definition of a valid surrogate endpoint; and (3) the relationship between these criteria and the consistency criterion (i.e., assurance against the "surrogate paradox"). This includes the result that ACN plus a strong version of ACS generally do not imply the Prentice definition nor the consistency criterion, but they do have these implications in special cases. Moreover, the converse does not hold except in a special case with a binary candidate surrogate. The results highlight that assumptions about the treatment effect on the clinical endpoint before the candidate surrogate is measured are influential for the ability to draw conclusions about the Prentice definition or consistency. In addition, we emphasize that in some scenarios that occur commonly in practice, the principal strata sub-populations for inference are identifiable from the observable data, in which cases the principal stratification framework has relatively high utility for the purpose of effect

  17. Surrogate Endpoint Evaluation: Principal Stratification Criteria and the Prentice Definition

    Science.gov (United States)

    Gilbert, Peter B.; Gabriel, Erin E.; Huang, Ying; Chan, Ivan S.F.

    2015-01-01

    A common problem of interest within a randomized clinical trial is the evaluation of an inexpensive response endpoint as a valid surrogate endpoint for a clinical endpoint, where a chief purpose of a valid surrogate is to provide a way to make correct inferences on clinical treatment effects in future studies without needing to collect the clinical endpoint data. Within the principal stratification framework for addressing this problem based on data from a single randomized clinical efficacy trial, a variety of definitions and criteria for a good surrogate endpoint have been proposed, all based on or closely related to the “principal effects” or “causal effect predictiveness (CEP)” surface. We discuss CEP-based criteria for a useful surrogate endpoint, including (1) the meaning and relative importance of proposed criteria including average causal necessity (ACN), average causal sufficiency (ACS), and large clinical effect modification; (2) the relationship between these criteria and the Prentice definition of a valid surrogate endpoint; and (3) the relationship between these criteria and the consistency criterion (i.e., assurance against the “surrogate paradox”). This includes the result that ACN plus a strong version of ACS generally do not imply the Prentice definition nor the consistency criterion, but they do have these implications in special cases. Moreover, the converse does not hold except in a special case with a binary candidate surrogate. The results highlight that assumptions about the treatment effect on the clinical endpoint before the candidate surrogate is measured are influential for the ability to draw conclusions about the Prentice definition or consistency. In addition, we emphasize that in some scenarios that occur commonly in practice, the principal strata sub-populations for inference are identifiable from the observable data, in which cases the principal stratification framework has relatively high utility for the purpose of

  18. Teaching Basic Programming Concepts to Young Primary School Students Using Tablets: Results of a Pilot Project

    Science.gov (United States)

    Fokides, Emmanuel

    2018-01-01

    The study presents the results of a project in which tablets and a ready-made application were used for teaching basic programming concepts to young primary school students (ages 7-9). A total of 135 students participated in the study, attending primary schools in Athens, Greece, divided into three groups. The first was taught conventionally. The…

  19. Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)†.

    Science.gov (United States)

    Bellera, C A; Penel, N; Ouali, M; Bonvalot, S; Casali, P G; Nielsen, O S; Delannes, M; Litière, S; Bonnetain, F; Dabakuyo, T S; Benjamin, R S; Blay, J-Y; Bui, B N; Collin, F; Delaney, T F; Duffaud, F; Filleron, T; Fiore, M; Gelderblom, H; George, S; Grimer, R; Grosclaude, P; Gronchi, A; Haas, R; Hohenberger, P; Issels, R; Italiano, A; Jooste, V; Krarup-Hansen, A; Le Péchoux, C; Mussi, C; Oberlin, O; Patel, S; Piperno-Neumann, S; Raut, C; Ray-Coquard, I; Rutkowski, P; Schuetze, S; Sleijfer, S; Stoeckle, E; Van Glabbeke, M; Woll, P; Gourgou-Bourgade, S; Mathoulin-Pélissier, S

    2015-05-01

    The use of potential surrogate end points for overall survival, such as disease-free survival (DFS) or time-to-treatment failure (TTF) is increasingly common in randomized controlled trials (RCTs) in cancer. However, the definition of time-to-event (TTE) end points is rarely precise and lacks uniformity across trials. End point definition can impact trial results by affecting estimation of treatment effect and statistical power. The DATECAN initiative (Definition for the Assessment of Time-to-event End points in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for RCT in sarcomas and gastrointestinal stromal tumors (GIST). We first carried out a literature review to identify TTE end points (primary or secondary) reported in publications of RCT. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points. Recommendations were developed through a validated consensus method formalizing the degree of agreement among experts. Recommended guidelines for the definition of TTE end points commonly used in RCT for sarcomas and GIST are provided for adjuvant and metastatic settings, including DFS, TTF, time to progression and others. Use of standardized definitions should facilitate comparison of trials' results, and improve the quality of trial design and reporting. These guidelines could be of particular interest to research scientists involved in the design, conduct, reporting or assessment of RCT such as investigators, statisticians, reviewers, editors or regulatory authorities. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  20. Establishing a group of endpoints in a parallel computer

    Science.gov (United States)

    Archer, Charles J.; Blocksome, Michael A.; Ratterman, Joseph D.; Smith, Brian E.; Xue, Hanhong

    2016-02-02

    A parallel computer executes a number of tasks, each task includes a number of endpoints and the endpoints are configured to support collective operations. In such a parallel computer, establishing a group of endpoints receiving a user specification of a set of endpoints included in a global collection of endpoints, where the user specification defines the set in accordance with a predefined virtual representation of the endpoints, the predefined virtual representation is a data structure setting forth an organization of tasks and endpoints included in the global collection of endpoints and the user specification defines the set of endpoints without a user specification of a particular endpoint; and defining a group of endpoints in dependence upon the predefined virtual representation of the endpoints and the user specification.

  1. TOXICOLOGICAL ENDPOINTS OF DOPING SUBSTANCES

    OpenAIRE

    BASARAN, A. Ahmet

    2018-01-01

    Athletes and non athletes weighlifters have tried to gain an unfairadvantage through the use doping substances since ancient times. Dopingsubstances although enhance sports performance, represent a risk to the healthof individuals and violate the sprit of competition. The use of prohibitedperformance enhancing drugs (PED’s) or methods to improve results incompetitive sports is referred as doping. Among the PED’s used areandrogenic-anabolic steroids (AASs), diuretics and masking agents, narkot...

  2. A summation free β+-endpoint spectrometer

    International Nuclear Information System (INIS)

    Keller, H.; Kirchner, R.; Klepper, O.; Roeckl, E.; Schardt, D.; Simon, R.S.; Kleinheinz, P.; Liang, C.F.; Paris, P.

    1990-08-01

    A β + -endpoint spectrometer is described, where positrons are observed in an 11-mm thick silicon detector in coincidence with subsequent γ-rays meausred in a germanium detector, and where the summing of the positron energy with the annihilation radiation is prevented by detecting both 511-keV quanta in opposite segments of a BGO ring surrounding the silicon detector. The procedure of measuring and analyzing the data is outlined for the decay of the 11/2 - -isomer of 149 Tb; its endpoint energy is determined to be 1853(10) keV, in agreement with the literature. The accuracy and reliability of β + -endpoint measurements is discussed in comparison to the EC/β + -ratio method. (orig.)

  3. End-point sharpness in thermometric titrimetry.

    Science.gov (United States)

    Tyrrell, H J

    1967-07-01

    It is shown that the sharpness of an end-point in a thermometric titration where the simple reaction A + B right harpoon over left harpoon AB takes place, depends on Kc(A') where K is the equilibrium constant for the reaction, and c(A') is the total concentration of the titrand (A) in the reaction mixture. The end-point is sharp if, (i) the enthalpy change in the reaction is not negligible, and (ii) Kc(A') > 10(3). This shows that it should, for example, be possible to titrate 0.1 M acid, pK(A) = 10, using a thennometric end-point. Some aspects of thermometric titrimetry when Kc(A') < 10(3) are also considered.

  4. Inconsistent selection and definition of local and regional endpoints in breast cancer research.

    Science.gov (United States)

    Moossdorff, M; van Roozendaal, L M; Schipper, R-J; Strobbe, L J A; Voogd, A C; Tjan-Heijnen, V C G; Smidt, M L

    2014-12-01

    Results in breast cancer research are reported using study endpoints. Most are composite endpoints (such as locoregional recurrence), consisting of several components (for example local recurrence) that are in turn composed of specific events (such as skin recurrence). Inconsistent endpoint selection and definition might lead to unjustified conclusions when comparing study outcomes. This study aimed to determine which locoregional endpoints are used in breast cancer studies, and how these endpoints and their components are defined. PubMed was searched for breast cancer studies published in nine leading journals in 2011. Articles using endpoints with a local or regional component were included and definitions were compared. Twenty-three different endpoints with a local or regional component were extracted from 44 articles. Most frequently used were disease-free survival (25 articles), recurrence-free survival (7), local control (4), locoregional recurrence-free survival (3) and event-free survival (3). Different endpoints were used for similar outcomes. Of 23 endpoints, five were not defined and 18 were defined only partially. Of these, 16 contained a local and 13 a regional component. Included events were not specified in 33 of 57 (local) and 27 of 50 (regional) cases. Definitions of local components inconsistently included carcinoma in situ and skin and chest wall recurrences. Regional components inconsistently included specific nodal sites and skin and chest wall recurrences. Breast cancer studies use many different endpoints with a locoregional component. Definitions of endpoints and events are either not provided or vary between trials. To improve transparency, facilitate trial comparison and avoid unjustified conclusions, authors should report detailed definitions of all endpoints. © 2014 BJS Society Ltd. Published by John Wiley & Sons Ltd.

  5. Biomechanical constraints on the feedforward regulation of endpoint stiffness.

    Science.gov (United States)

    Hu, Xiao; Murray, Wendy M; Perreault, Eric J

    2012-10-01

    Although many daily tasks tend to destabilize arm posture, it is still possible to have stable interactions with the environment by regulating the multijoint mechanics of the arm in a task-appropriate manner. For postural tasks, this regulation involves the appropriate control of endpoint stiffness, which represents the stiffness of the arm at the hand. Although experimental studies have been used to evaluate endpoint stiffness control, including the orientation of maximal stiffness, the underlying neural strategies remain unknown. Specifically, the relative importance of feedforward and feedback mechanisms has yet to be determined due to the difficulty separately identifying the contributions of these mechanisms in human experiments. This study used a previously validated three-dimensional musculoskeletal model of the arm to quantify the degree to which the orientation of maximal endpoint stiffness could be changed using only steady-state muscle activations, used to represent feedforward motor commands. Our hypothesis was that the feedforward control of endpoint stiffness orientation would be significantly constrained by the biomechanical properties of the musculoskeletal system. Our results supported this hypothesis, demonstrating substantial biomechanical constraints on the ability to regulate endpoint stiffness throughout the workspace. The ability to regulate stiffness orientation was further constrained by additional task requirements, such as the need to support the arm against gravity or exert forces on the environment. Together, these results bound the degree to which slowly varying feedforward motor commands can be used to regulate the orientation of maximum arm stiffness and provide a context for better understanding conditions in which feedback control may be needed.

  6. Forecasting interest rates with shifting endpoints

    DEFF Research Database (Denmark)

    Van Dijk, Dick; Koopman, Siem Jan; Wel, Michel van der

    2014-01-01

    We consider forecasting the term structure of interest rates with the assumption that factors driving the yield curve are stationary around a slowly time-varying mean or ‘shifting endpoint’. The shifting endpoints are captured using either (i) time series methods (exponential smoothing) or (ii......) long-range survey forecasts of either interest rates or inflation and output growth, or (iii) exponentially smoothed realizations of these macro variables. Allowing for shifting endpoints in yield curve factors provides substantial and significant gains in out-of-sample predictive accuracy, relative...... to stationary and random walk benchmarks. Forecast improvements are largest for long-maturity interest rates and for long-horizon forecasts....

  7. Observations on Three Endpoint Properties and Their Relationship to Regulatory Outcomes of European Oncology Marketing Applications.

    Science.gov (United States)

    Liberti, Lawrence; Stolk, Pieter; McAuslane, James Neil; Schellens, Jan; Breckenridge, Alasdair M; Leufkens, Hubert

    2015-06-01

    Guidance and exploratory evidence indicate that the type of endpoints and the magnitude of their outcome can define a therapy's clinical activity; however, little empirical evidence relates specific endpoint properties with regulatory outcomes. We explored the relationship of 3 endpoint properties to regulatory outcomes by assessing 50 oncology marketing authorization applications (MAAs; reviewed from 2009 to 2013). Overall, 16 (32%) had a negative outcome. The most commonly used hard endpoints were overall survival (OS) and the duration of response or stable disease. OS was a component of 91% approved and 63% failed MAAs. The most commonly used surrogate endpoints were progression-free survival (PFS), response rate, and health-related quality of life assessments. There was no difference (p = .3801) between the approved and failed MAA cohorts in the proportion of hard endpoints used. A mean of slightly more than four surrogate endpoints were used per approved MAA compared with slightly more than two for failed MAAs. Longer OS and PFS duration outcomes were generally associated with approvals, often when not statistically significant. The approved cohort was associated with a preponderance of statistically significant (p < .05) improvements in primary endpoints (p < .0001 difference between the approved and failed groups). Three key endpoint properties (type of endpoint [hard/surrogate], magnitude of an endpoint outcome, and its statistical significance) are consistent with the European Medicines Agency guidance and, notwithstanding the contribution of unique disease-specific circumstances, are associated with a predictable positive outcome for oncology MAAs. Regulatory decisions made by the European Medicines Agency determine which new medicines will be available to European prescribers and for which therapeutic indications. Regulatory success or failure can be influenced by many factors. This study assessed three key properties of endpoints used in

  8. Modeling hard clinical end-point data in economic analyses.

    Science.gov (United States)

    Kansal, Anuraag R; Zheng, Ying; Palencia, Roberto; Ruffolo, Antonio; Hass, Bastian; Sorensen, Sonja V

    2013-11-01

    The availability of hard clinical end-point data, such as that on cardiovascular (CV) events among patients with type 2 diabetes mellitus, is increasing, and as a result there is growing interest in using hard end-point data of this type in economic analyses. This study investigated published approaches for modeling hard end-points from clinical trials and evaluated their applicability in health economic models with different disease features. A review of cost-effectiveness models of interventions in clinically significant therapeutic areas (CV diseases, cancer, and chronic lower respiratory diseases) was conducted in PubMed and Embase using a defined search strategy. Only studies integrating hard end-point data from randomized clinical trials were considered. For each study included, clinical input characteristics and modeling approach were summarized and evaluated. A total of 33 articles (23 CV, eight cancer, two respiratory) were accepted for detailed analysis. Decision trees, Markov models, discrete event simulations, and hybrids were used. Event rates were incorporated either as constant rates, time-dependent risks, or risk equations based on patient characteristics. Risks dependent on time and/or patient characteristics were used where major event rates were >1%/year in models with fewer health states (Models of infrequent events or with numerous health states generally preferred constant event rates. The detailed modeling information and terminology varied, sometimes requiring interpretation. Key considerations for cost-effectiveness models incorporating hard end-point data include the frequency and characteristics of the relevant clinical events and how the trial data is reported. When event risk is low, simplification of both the model structure and event rate modeling is recommended. When event risk is common, such as in high risk populations, more detailed modeling approaches, including individual simulations or explicitly time-dependent event rates, are

  9. HTGR-GT primary coolant transient resulting from postulated turbine deblading

    International Nuclear Information System (INIS)

    Cadwallader, G.J.; Deremer, R.K.

    1980-11-01

    The turbomachine is located within the primary coolant system of a nuclear closed cycle gas turbine plant (HTGR-GT). The deblading of the turbine can cause a rapid pressure equilibration transient that generates significant loads on other components in the system. Prediction of and design for this transient are important aspects of assuring the safety of the HTGR-GT. This paper describes the adaptation and use of the RATSAM program to analyze the rapid fluid transient throughout the primary coolant system during a spectrum of turbine deblading events. Included are discussions of (1) specific modifications and improvements to the basic RATSAM program, which is also briefly described; (2) typical results showing the expansion wave moving upstream from the debladed turbine through the primary coolant system; and (3) the effect on the transient results of different plenum volumes, flow resistances, times to deblade, and geometries that can choke the flow

  10. Laboratory test result interpretation for primary care doctors in South Africa

    Directory of Open Access Journals (Sweden)

    Naadira Vanker

    2017-03-01

    Full Text Available Background: Challenges and uncertainties with test result interpretation can lead to diagnostic errors. Primary care doctors are at a higher risk than specialists of making these errors, due to the range in complexity and severity of conditions that they encounter. Objectives: This study aimed to investigate the challenges that primary care doctors face with test result interpretation, and to identify potential countermeasures to address these. Methods: A survey was sent out to 7800 primary care doctors in South Africa. Questionnaire themes included doctors’ uncertainty with interpreting test results, mechanisms used to overcome this uncertainty, challenges with appropriate result interpretation, and perceived solutions for interpreting results. Results: Of the 552 responses received, the prevalence of challenges with result interpretation was estimated in an average of 17% of diagnostic encounters. The most commonly-reported challenges were not receiving test results in a timely manner (51% of respondents and previous results not being easily available (37%. When faced with diagnostic uncertainty, 84% of respondents would either follow-up and reassess the patient or discuss the case with a specialist, and 67% would contact a laboratory professional. The most useful test utilisation enablers were found to be: interpretive comments (78% of respondents, published guidelines (74%, and a dedicated laboratory phone line (72%. Conclusion: Primary care doctors acknowledge uncertainty with test result interpretation. Potential countermeasures include the addition of patient-specific interpretive comments, the availability of guidelines or algorithms, and a dedicated laboratory phone line. The benefit of enhanced test result interpretation would reduce diagnostic error rates.

  11. Digital Educational Games and Mathematics. Results of a Case Study in Primary School Settings

    Science.gov (United States)

    Fokides, Emmanuel

    2018-01-01

    The study presents the results of a project in which a series of digital games were used for teaching Mathematics to first, fourth, and sixth-grade primary school students (ages 6-7, 8-9, and 11-12). Mathematics was selected as the teaching subject because of the difficulties students face in understanding basic math concepts. Although digital…

  12. Concordant testing results between various Human Papillomavirus assays in primary cervical cancer screening

    DEFF Research Database (Denmark)

    de Thurah, Lena; Bonde, Jesper; Hoa Lam, Janni Uyen

    2018-01-01

    OBJECTIVES: Human Papillomavirus (HPV) assays are increasingly used for primary cervical screening and HPV vaccination effect monitoring. We undertook a systematic literature review to determine the concordance in positive test results (i.e., detection of HPV infections) between Hybrid Capture 2 ...

  13. Choice of futility boundaries for group sequential designs with two endpoints

    Directory of Open Access Journals (Sweden)

    Svenja Schüler

    2017-08-01

    Full Text Available Abstract Background In clinical trials, the opportunity for an early stop during an interim analysis (either for efficacy or for futility may relevantly save time and financial resources. This is especially important, if the planning assumptions required for power calculation are based on a low level of evidence. For example, when including two primary endpoints in the confirmatory analysis, the power of the trial depends on the effects of both endpoints and on their correlation. Assessing the feasibility of such a trial is therefore difficult, as the number of parameter assumptions to be correctly specified is large. For this reason, so-called ‘group sequential designs’ are of particular importance in this setting. Whereas the choice of adequate boundaries to stop a trial early for efficacy has been broadly discussed in the literature, the choice of optimal futility boundaries has not been investigated so far, although this may have serious consequences with respect to performance characteristics. Methods In this work, we propose a general method to construct ‘optimal’ futility boundaries according to predefined criteria. Further, we present three different group sequential designs for two endpoints applying these futility boundaries. Our methods are illustrated by a real clinical trial example and by Monte-Carlo simulations. Results By construction, the provided method of choosing futility boundaries maximizes the probability to correctly stop in case of small or opposite effects while limiting the power loss and the probability of stopping the study ‘wrongly’. Our results clearly demonstrate the benefit of using such ‘optimal’ futility boundaries, especially compared to futility boundaries commonly applied in practice. Conclusions As the properties of futility boundaries are often not considered in practice and unfavorably chosen futility boundaries may imply bad properties of the study design, we recommend assessing the

  14. Therapy of Primary Hypothyroidism with α-Lipoic Acid Review of Studies Results

    Directory of Open Access Journals (Sweden)

    A.V. Savustyanenko

    2016-05-01

    Full Text Available Primary hypothyroidism occurs in the general population with an incidence of 0.5–1 %, and includes congenital and acquired (due to autoimmune thyroiditis, after surgical removal of the thyroid gland or treatment with radioactive iodine forms. The basic treatment of primary hypothyroidism is replacement therapy with L-thyroxine. Combined administration of L-thyroxine and α-lipoic acid resulted in more marked decrease of oxidative stress, hyperlipidemia, hyperactivity of the immune system, endothelial dysfunction and neurological disorders, observed in patients with primary hypothyroidism, as compared to monotherapy with L-thyroxine. α-lipoic acid use was effective in adults and children, in case of parenteral and/or oral administration.

  15. Sperm count as a surrogate endpoint for male fertility control.

    Science.gov (United States)

    Benda, Norbert; Gerlinger, Christoph

    2007-11-30

    When assessing the effectiveness of a hormonal method of fertility control in men, the classical approach used for the assessment of hormonal contraceptives in women, by estimating the pregnancy rate or using a life-table analysis for the time to pregnancy, is difficult to apply in a clinical development program. The main reasons are the dissociation of the treated unit, i.e. the man, and the observed unit, i.e. his female partner, the high variability in the frequency of male intercourse, the logistical cost and ethical concerns related to the monitoring of the trial. A reasonable surrogate endpoint of the definite endpoint time to pregnancy is sperm count. In addition to the avoidance of the mentioned problems, trials that compare different treatments are possible with reasonable sample sizes, and study duration can be shorter. However, current products do not suppress sperm production to 100 per cent in all men and the sperm count is only observed with measurement error. Complete azoospermia might not be necessary in order to achieve an acceptable failure rate compared with other forms of male fertility control. Therefore, the use of sperm count as a surrogate endpoint must rely on the results of a previous trial in which both the definitive- and surrogate-endpoint results were assessed. The paper discusses different estimation functions of the mean pregnancy rate (corresponding to the cumulative hazard) that are based on the results of sperm count trial and a previous trial in which both sperm count and time to pregnancy were assessed, as well as the underlying assumptions. Sample size estimations are given for pregnancy rate estimation with a given precision.

  16. Biomarkers and correlative endpoints for immunotherapy trials.

    Science.gov (United States)

    Morse, Michael A; Osada, Takuya; Hobeika, Amy; Patel, Sandip; Lyerly, H Kim

    2013-01-01

    Immunotherapies for lung cancer are reaching phase III clinical trial, but the ultimate success likely will depend on developing biomarkers to guide development and choosing patient populations most likely to benefit. Because the immune response to cancer involves multiple cell types and cytokines, some spatially and temporally separated, it is likely that multiple biomarkers will be required to fully characterize efficacy of the vaccine and predict eventual benefit. Peripheral blood markers of response, such as the ELISPOT assay and cytokine flow cytometry analyses of peripheral blood mononuclear cells following immunotherapy, remain the standard approach, but it is increasingly important to obtain tissue to study the immune response at the site of the tumor. Earlier clinical endpoints such as response rate and progression-free survival do not correlate with overall survival demonstrated for some immunotherapies, suggesting the need to develop other intermediary clinical endpoints. Insofar as all these biomarkers and surrogate endpoints are relevant in multiple malignancies, it may be possible to extrapolate findings to immunotherapy of lung cancer.

  17. A data-driven weighting scheme for multivariate phenotypic endpoints recapitulates zebrafish developmental cascades

    Energy Technology Data Exchange (ETDEWEB)

    Zhang, Guozhu, E-mail: gzhang6@ncsu.edu [Bioinformatics Research Center, North Carolina State University, Raleigh, NC (United States); Roell, Kyle R., E-mail: krroell@ncsu.edu [Bioinformatics Research Center, North Carolina State University, Raleigh, NC (United States); Truong, Lisa, E-mail: lisa.truong@oregonstate.edu [Department of Environmental and Molecular Toxicology, Sinnhuber Aquatic Research Laboratory, Oregon State University, Corvallis, OR (United States); Tanguay, Robert L., E-mail: robert.tanguay@oregonstate.edu [Department of Environmental and Molecular Toxicology, Sinnhuber Aquatic Research Laboratory, Oregon State University, Corvallis, OR (United States); Reif, David M., E-mail: dmreif@ncsu.edu [Bioinformatics Research Center, North Carolina State University, Raleigh, NC (United States); Department of Biological Sciences, Center for Human Health and the Environment, North Carolina State University, Raleigh, NC (United States)

    2017-01-01

    Zebrafish have become a key alternative model for studying health effects of environmental stressors, partly due to their genetic similarity to humans, fast generation time, and the efficiency of generating high-dimensional systematic data. Studies aiming to characterize adverse health effects in zebrafish typically include several phenotypic measurements (endpoints). While there is a solid biomedical basis for capturing a comprehensive set of endpoints, making summary judgments regarding health effects requires thoughtful integration across endpoints. Here, we introduce a Bayesian method to quantify the informativeness of 17 distinct zebrafish endpoints as a data-driven weighting scheme for a multi-endpoint summary measure, called weighted Aggregate Entropy (wAggE). We implement wAggE using high-throughput screening (HTS) data from zebrafish exposed to five concentrations of all 1060 ToxCast chemicals. Our results show that our empirical weighting scheme provides better performance in terms of the Receiver Operating Characteristic (ROC) curve for identifying significant morphological effects and improves robustness over traditional curve-fitting approaches. From a biological perspective, our results suggest that developmental cascade effects triggered by chemical exposure can be recapitulated by analyzing the relationships among endpoints. Thus, wAggE offers a powerful approach for analysis of multivariate phenotypes that can reveal underlying etiological processes. - Highlights: • Introduced a data-driven weighting scheme for multiple phenotypic endpoints. • Weighted Aggregate Entropy (wAggE) implies differential importance of endpoints. • Endpoint relationships reveal developmental cascade effects triggered by exposure. • wAggE is generalizable to multi-endpoint data of different shapes and scales.

  18. [The reform of primary health care: the economic, care and satisfaction results].

    Science.gov (United States)

    Durán, J; Jodar, G; Pociello, V; Parellada, N; Martín, A; Pradas, J

    1999-05-15

    To compare the overall effect on the general public before and after the primary care reform, its economic outcome and professional satisfaction, following the model of the European Foundation for Quality Management. A descriptive analysis of results at reformed primary care centres compared with results at non-reformed centres in the same city. The study was conducted at Sant Boi de Llobregat, a town of 77,591 inhabitants in Baix Llobregat county (Barcelona). 32.7% of the population was covered by two reformed centres. The rest was covered by one single non-reformed primary care centre. Clinical audits and data on pharmaceutical prescription quality were used to find attendance. For economic results, the formula of attribution of cost/inhabitant and cost/inhabitant seen, including the costs of labour, structure, referral, further tests and pharmacy, were used. The satisfaction of the outside customer (user) was measured by a population survey. Internal customer satisfaction was measured by a survey of the professionals. Results were compared with those for 1997. The study showed that the reformed primary care sector's results, measured in terms of professional satisfaction, user-outside customer, attendance, economic results and social impact, were better than the non-reformed sector's. Inside and outside customers' satisfaction was higher in the reformed network. The cost per inhabitant in the reformed network was 31,874 pesetas, against 25,177 in the non-reformed network. The cost per inhabitant seen was 34,482 and 44,603, respectively. The reform creates efficient resource management and greater satisfaction of the general public and professionals, when an indicator sensitive to the real use of services is used.

  19. Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate? System: three- and six-month endpoint results from the FAST-EU study

    OpenAIRE

    Bongers, Marlies; Br?lmann, Hans; Gupta, Janesh; Garza-Leal, Jos? Gerardo; Toub, David

    2014-01-01

    This was a prospective, longitudinal, multicenter, single-arm controlled trial, using independent core laboratory validation of MRI results, to establish the effectiveness and confirm the safety of the VizAblate? System in the treatment of symptomatic uterine fibroids. The VizAblate System is a transcervical device that ablates fibroids with radiofrequency energy, guided by a built-in intrauterine ultrasound probe. Fifty consecutive women with symptomatic uterine fibroids received treatment w...

  20. Exposing the cancer genome atlas as a SPARQL endpoint

    Science.gov (United States)

    Deus, Helena F.; Veiga, Diogo F.; Freire, Pablo R.; Weinstein, John N.; Mills, Gordon B.; Almeida, Jonas S.

    2011-01-01

    The Cancer Genome Atlas (TCGA) is a multidisciplinary, multi-institutional effort to characterize several types of cancer. Datasets from biomedical domains such as TCGA present a particularly challenging task for those interested in dynamically aggregating its results because the data sources are typically both heterogeneous and distributed. The Linked Data best practices offer a solution to integrate and discover data with those characteristics, namely through exposure of data as Web services supporting SPARQL, the Resource Description Framework query language. Most SPARQL endpoints, however, cannot easily be queried by data experts. Furthermore, exposing experimental data as SPARQL endpoints remains a challenging task because, in most cases, data must first be converted to Resource Description Framework triples. In line with those requirements, we have developed an infrastructure to expose clinical, demographic and molecular data elements generated by TCGA as a SPARQL endpoint by assigning elements to entities of the Simple Sloppy Semantic Database (S3DB) management model. All components of the infrastructure are available as independent Representational State Transfer (REST) Web services to encourage reusability, and a simple interface was developed to automatically assemble SPARQL queries by navigating a representation of the TCGA domain. A key feature of the proposed solution that greatly facilitates assembly of SPARQL queries is the distinction between the TCGA domain descriptors and data elements. Furthermore, the use of the S3DB management model as a mediator enables queries to both public and protected data without the need for prior submission to a single data source. PMID:20851208

  1. Revisiting the symptom iceberg in today's primary care: results from a UK population survey

    Directory of Open Access Journals (Sweden)

    Hannaford Philip C

    2011-04-01

    Full Text Available Abstract Background Recent changes in UK primary care have increased the range of services and healthcare professionals available for advice. Furthermore, the UK government has promoted greater use of both self-care and the wider primary care team for managing symptoms indicative of self-limiting illness. We do not know how the public has been responding to these strategies. The aim of this study was to describe the current use of different management strategies in the UK for a range of symptoms and identify the demographic, socio-economic and symptom characteristics associated with these different approaches. Methods An age and sex stratified random sample of 8,000 adults (aged 18-60, drawn from twenty general practices across the UK, were sent a postal questionnaire. The questionnaire collected detailed information on 25 physical and psychological symptoms ranging from those usually indicative of minor illness to those which could be indicative of serious conditions. Information on symptom characteristics, actions taken to manage the symptoms and demographic/socio-economic details were also collected. Results Just under half of all symptoms reported resulted in respondents doing nothing at all. Lay-care was used for 35% of symptoms and primary care health professionals were consulted for 12% of symptoms. OTC medicine use was the most common lay-care strategy (used for 25% of all symptom episodes. The GP was the most common health professional consulted (consulted for 8% of all symptom episodes while use of other primary care health professionals was very small (each consulted for less than 2% of symptom episodes. The actions taken for individual symptoms varied substantially although some broad patterns emerged. Symptom characteristics (in particular severity, duration and interference with daily life were more commonly associated with actions taken than demographic or socio-economic characteristics. Conclusion While the use of lay-care was

  2. Prevalence of chronic pancreatitis: Results of a primary care physician-based population study.

    Science.gov (United States)

    Capurso, Gabriele; Archibugi, Livia; Pasquali, Piera; Aceti, Alessandro; Balducci, Paolo; Bianchi, Patrizia; Buono, Francesco; Camerucci, Stefano; Cantarini, Rosanna; Centofanti, Sergio; Colantonio, Patrizia; Cremaschi, Riccarda; Crescenzi, Sergio; Di Mauro, Caterina; Di Renzi, Davide; Filabozzi, Andrea; Fiorillo, Alfonso; Giancaspro, Giuseppe; Giovannetti, Paola; Lanna, Giuseppe; Medori, Claudio; Merletti, Emilio; Nunnari, Enzo; Paris, Francesca; Pavone, Marco; Piacenti, Angela; Rossi, Almerindo; Scamuffa, Maria Cristina; Spinelli, Giovanni; Taborchi, Marco; Valente, Biagio; Villanova, Antonella; Chiriatti, Alberto; Delle Fave, Gianfranco

    2017-05-01

    Data on chronic pancreatitis prevalence are scanty and usually limited to hospital-based studies. Investigating chronic pancreatitis prevalence in primary care. Participating primary care physicians reported the prevalence of chronic pancreatitis among their registered patients, environmental factors and disease characteristics. The data were centrally reviewed and chronic pancreatitis cases defined according to M-ANNHEIM criteria for diagnosis and severity and TIGAR-O classification for etiology. Twenty-three primary care physicians participated in the study. According to their judgment, 51 of 36.401 patients had chronic pancreatitis. After reviewing each patient data, 11 turned out to have definite, 5 probable, 19 borderline and 16 uncertain disease. Prevalence was 30.2/100.000 for definite cases and 44.0/100.000 for definite plus probable cases. Of the 16 patients with definite/probable diagnosis, 8 were male, with mean age of 55.6 (±16.7). Four patients had alcoholic etiology, 5 post-acute/recurrent pancreatitis, 6 were deemed to be idiopathic. Four had pancreatic exocrine insufficiency, 10 were receiving pancreatic enzymes, and six had pain. Most patients had initial stage and non-severe disease. This is the first study investigating the prevalence of chronic pancreatitis in primary care. Results suggest that the prevalence in this context is higher than in hospital-based studies, with specific features, possibly representing an earlier disease stage. Copyright © 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  3. Preliminary result in patients with primary hepatoma treated by stereotactic radiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Kang, Ki Mun; Choi, Ihl Bohng; Kim, In Ah; Choi, Byung Ock; Kang, Young Nam; Han, Sung Tae; Chung, Gyu Won [College of Medicine, Catholic Univ., Seoul (Korea, Republic of); Chai, Gyu Young [College of Medicine, Gyeongsang National Univ., Chinju (Korea, Republic of)

    2001-03-01

    It is not common to evaluate the response of the fractionated stereotactic radiotherapy (SRT) to primary hepatoma as compared with conventional radiotherapy. The purpose of the study was to take the preliminary result on the clinical trial of primary hepatoma by SRT. From July 1999 to March 2000, thirty three patients were hospitalized in the St. Mary's Hospital, and treated with SRT for extracranial tumors. Among them, 13 patients were diagnosed to primary hepatoma and then applied by frameless SRT using 6 MV linac accelerator. There were 12 male and 1 female patients. They had the age of 44-66 year old (median: 59) and the tumor size of 10-825 cc (median: 185 cc). SRT was given to them 3-5 fractions a week (5 Gy/fraction, 90% isodose line) for 2-3 weeks. Median dose of SRT was 50 Gy and the range was 30-50 Gy. Follow-up period ranged from 3 months to 13 months with median of 8 months. After treating SRT to thirteen patients with primary hepatoma, the response of the tumor was examined by abdominal CT: they are classified by 1 complete regression (7.7%), 7 partial regression (53.8%), 4 minimal regression (30.8%), 1 stable disease (7.7%). The positive responses more than partial remission were 8 patients (61.5%) after the treatment. The level of serum alpha-fetoprotein (AFP) after the treatment as compared with pretreatment had been 92.3% decreased. There was no severe complication except dyspepsia 84.6%, mild nausea 69.2%, transient decreased of hepatic function 15.4% and fever 7.7%. SRT to the patients with primary hepatoma was potentially suggested to become the safe and more effective tool than the conventional radiotherapy even though there were relatively short duration of follow-up and small numbers to be tested.

  4. Do primary care professionals agree about progress with implementation of primary care teams: results from a cross sectional study.

    Science.gov (United States)

    Tierney, E; O'Sullivan, M; Hickey, L; Hannigan, A; May, C; Cullen, W; Kennedy, N; Kineen, L; MacFarlane, A

    2016-11-22

    Primary care is the cornerstone of healthcare reform with policies across jurisdictions promoting interdisciplinary team working. The effective implementation of such health policies requires understanding the perspectives of all actors. However, there is a lack of research about health professionals' views of this process. This study compares Primary Healthcare Professionals' perceptions of the effectiveness of the Primary Care Strategy and Primary Care Team (PCT) implementation in Ireland. Design and Setting: e-survey of (1) General Practitioners (GPs) associated with a Graduate Medical School (N = 100) and (2) Primary Care Professionals in 3 of 4 Health Service Executive (HSE) regions (N = 2309). After piloting, snowball sampling was used to administer the survey. Descriptive analysis was carried out using SPSS. Ratings across groups were compared using non-parametric tests. There were 569 responses. Response rates varied across disciplines (71 % for GPs, 22 % for other Primary Healthcare Professionals (PCPs). Respondents across all disciplines viewed interdisciplinary working as important. Respondents agreed on lack of progress of implementation of formal PCTs (median rating of 2, where 1 is no progress at all and 5 is complete implementation). GPs were more negative about the effectiveness of the Strategy to promote different disciplines to work together (median rating of 2 compared to 3 for clinical therapists and 3.5 for nurses, P = 0.001). Respondents identified resources and GP participation as most important for effective team working. Protected time for meetings and capacity to manage workload for meetings were rated as very important factors for effective team working by GPs, clinical therapists and nurses. A building for co-location of teams was rated as an important factor by nurses and clinical therapists though GPs rated it as less important. Payment to attend meetings and contractual arrangements were considered important factors by

  5. Endpoint singularities in unintegrated parton distributions

    CERN Document Server

    Hautmann, F

    2007-01-01

    We examine the singular behavior from the endpoint region x -> 1 in parton distributions unintegrated in both longitudinal and transverse momenta. We identify and regularize the singularities by using the subtraction method, and compare this with the cut-off regularization method. The counterterms for the distributions with subtractive regularization are given in coordinate space by compact all-order expressions in terms of eikonal-line operators. We carry out an explicit calculation at one loop for the unintegrated quark distribution. We discuss the relation of the unintegrated parton distributions in subtractive regularization with the ordinary parton distributions.

  6. Prayer for Health and Primary Care: Results From the 2002 National Health Interview Survey

    Science.gov (United States)

    Wilkinson, Joanne E.; Saper, Robert B.; Rosen, Amy K.; Welles, Seth L.; Culpepper, Larry

    2009-01-01

    Background and Objectives Prayer for health (PFH) is common; in 2002, 35% of US adults prayed for their health. We examined the relationship of PFH and primary care visits, with a special focus on African American women, using data from the 2002 National Health Interview Survey (NHIS). Methods We used chi-square analyses to compare the demographic (age group, gender, race, region, marital status, educational level, ethnicity) and health-related covariates (alcohol use, smoking status, and selected medical conditions) between individuals who did and did not pray for their health in the past year. Univariate associations between PFH and visit to primary care provider (PCP), with Mantel-Haenszel adjustment for confounding, were determined. Multivariate regression was used to determine independent factors associated with PFH and PCP visit, with SUDAAN to adjust for the clustered survey design. Results Subjects who prayed were more likely to be female, older than 58, Black, Southern, separated, divorced or widowed, and nondrinkers. Subjects who prayed were also more likely to have seen a PCP within the past year. Black women who prayed were also more likely to see a PCP. Conclusions These findings suggest that people who pray for their health do so in addition to, not instead of, seeking primary care. This finding is maintained but with a smaller effect size, in Black women. PMID:18830839

  7. Ovarian cancer clinical trial endpoints: Society of Gynecologic Oncology white paper

    Science.gov (United States)

    Herzog, Thomas J.; Armstrong, Deborah K.; Brady, Mark F.; Coleman, Robert L.; Einstein, Mark H.; Monk, Bradley J.; Mannel, Robert S.; Thigpen, J. Tate; Umpierre, Sharee A.; Villella, Jeannine A.; Alvarez, Ronald D.

    2015-01-01

    Objective To explore the value of multiple clinical endpoints in the unique setting of ovarian cancer. Methods A clinical trial workgroup was established by the Society of Gynecologic Oncology to develop a consensus statement via multiple conference calls, meetings and white paper drafts. Results Clinical trial endpoints have profound effects on late phase clinical trial design, result interpretation, drug development, and regulatory approval of therapeutics. Selection of the optimal clinical trial endpoint is particularly provocative in ovarian cancer where long overall survival (OS) is observed. The lack of new regulatory approvals and the lack of harmony between regulatory bodies globally for ovarian cancer therapeutics are of concern. The advantages and disadvantages of the numerous endpoints available are herein discussed within the unique context of ovarian cancer where both crossover and post-progression therapies potentially uncouple surrogacy between progression-free survival (PFS) and OS, the two most widely supported and utilized endpoints. The roles of patient reported outcomes (PRO) and health related quality of life (HRQoL) are discussed, but even these widely supported parameters are affected by the unique characteristics of ovarian cancer where a significant percentage of patients may be asymptomatic. Original data regarding the endpoint preferences of ovarian cancer advocates is presented. Conclusions Endpoint selection in ovarian cancer clinical trials should reflect the impact on disease burden and unique characteristics of the treatment cohort while reflecting true patient benefit. Both OS and PFS have led to regulatory approvals and are clinically important. OS remains the most objective and accepted endpoint because it is least vulnerable to bias; however, the feasibility of OS in ovarian cancer is compromised by the requirement for large trial size, prolonged time-line for final analysis, and potential for unintended loss of treatment effect

  8. Serum urate as surrogate endpoint for flares in people with gout

    DEFF Research Database (Denmark)

    Stamp, Lisa K; Birger Morillon, Melanie; Taylor, William J

    2018-01-01

    Objectives The primary efficacy outcome in trials of urate lowering therapy (ULT) for gout is serum urate (SU). The aim of this study was to examine the strength of the relationship between SU and patient-important outcomes to determine whether SU is an adequate surrogate endpoint for clinical tr...

  9. Evaluation of diagnostic serological results in cases of suspected primary syphilis infection.

    Science.gov (United States)

    Gratzer, Beau; Pohl, Daniel; Hotton, Anna L

    2014-05-01

    Reverse sequence screening for syphilis, in which an automatable treponemal assay (enzyme immunoassay [EIA]/chemiluminescence assay [CIA]) is performed first and followed by a nontreponemal test for reactive specimens, has been used increasingly in the United States. The EIA is objective, efficient, and believed to be more sensitive than the rapid plasma reagin (RPR) because treponemal antibodies appear before nontreponemal antibodies. We sought to compare the sensitivity of a commonly used EIA, the Trep-Sure EIA (TS-EIA), to the RPR in cases of suspected primary syphilis infection in our clinic. A retrospective medical record review of patients with sexually transmitted infection clinic visits from January 2009 to December 2011 was conducted, and 52 patients met the following inclusion criteria: suspected primary syphilis symptoms, at least 1 positive syphilis test result at visit, and no history of syphilis. Sensitivity analyses compared the TS-EIA and RPR, using the reference standard of concordantly positive/reactive TS-EIA/RPR or positive fluorescent treponemal antibody absorption test (FTA-ABS) result. We considered equivocal TS-EIA results to be positive for sensitivity calculations because such results typically reflex to additional testing and therefore may still result in identifying new infections. Twenty-eight (53.8%) of the 52 patients had a positive or equivocal TS-EIA. Twenty-five (89.3%) of those were RPR reactive; the remaining 3 (10.7%) were RPR nonreactive, FTA-ABS positive. Forty patients (76.9%) had a positive RPR, including 15 patients (37.5%) with negative TS-EIA results; all 15 were FTA-ABS positive. Nine additional patients were TS-EIA negative and RPR nonreactive but had a positive FTA-ABS result. The RPR was significantly more sensitive than the EIA (76.9% vs. 53.8%, P = 0.005). Trep-Sure EIA positivity was also significantly associated with higher median RPR titer (P = 0.011). Use of the TS-EIA may result in underdetection of primary

  10. Ovarian cancer clinical trial endpoints: Society of Gynecologic Oncology white paper.

    Science.gov (United States)

    Herzog, Thomas J; Armstrong, Deborah K; Brady, Mark F; Coleman, Robert L; Einstein, Mark H; Monk, Bradley J; Mannel, Robert S; Thigpen, J Tate; Umpierre, Sharee A; Villella, Jeannine A; Alvarez, Ronald D

    2014-01-01

    To explore the value of multiple clinical endpoints in the unique setting of ovarian cancer. A clinical trial workgroup was established by the Society of Gynecologic Oncology to develop a consensus statement via multiple conference calls, meetings and white paper drafts. Clinical trial endpoints have profound effects on late phase clinical trial design, result interpretation, drug development, and regulatory approval of therapeutics. Selection of the optimal clinical trial endpoint is particularly provocative in ovarian cancer where long overall survival (OS) is observed. The lack of new regulatory approvals and the lack of harmony between regulatory bodies globally for ovarian cancer therapeutics are of concern. The advantages and disadvantages of the numerous endpoints available are herein discussed within the unique context of ovarian cancer where both crossover and post-progression therapies potentially uncouple surrogacy between progression-free survival (PFS) and OS, the two most widely supported and utilized endpoints. The roles of patient reported outcomes (PRO) and health related quality of life (HRQoL) are discussed, but even these widely supported parameters are affected by the unique characteristics of ovarian cancer where a significant percentage of patients may be asymptomatic. Original data regarding the endpoint preferences of ovarian cancer advocates is presented. Endpoint selection in ovarian cancer clinical trials should reflect the impact on disease burden and unique characteristics of the treatment cohort while reflecting true patient benefit. Both OS and PFS have led to regulatory approvals and are clinically important. OS remains the most objective and accepted endpoint because it is least vulnerable to bias; however, the feasibility of OS in ovarian cancer is compromised by the requirement for large trial size, prolonged time-line for final analysis, and potential for unintended loss of treatment effect from active post-progression therapies

  11. Placebo use in the United kingdom: results from a national survey of primary care practitioners.

    Directory of Open Access Journals (Sweden)

    Jeremy Howick

    Full Text Available OBJECTIVES: Surveys in various countries suggest 17% to 80% of doctors prescribe 'placebos' in routine practice, but prevalence of placebo use in UK primary care is unknown. METHODS: We administered a web-based questionnaire to a representative sample of UK general practitioners. Following surveys conducted in other countries we divided placebos into 'pure' and 'impure'. 'Impure' placebos are interventions with clear efficacy for certain conditions but are prescribed for ailments where their efficacy is unknown, such as antibiotics for suspected viral infections. 'Pure' placebos are interventions such as sugar pills or saline injections without direct pharmacologically active ingredients for the condition being treated. We initiated the survey in April 2012. Two reminders were sent and electronic data collection closed after 4 weeks. RESULTS: We surveyed 1715 general practitioners and 783 (46% completed our questionnaire. Our respondents were similar to those of all registered UK doctors suggesting our results are generalizable. 12% (95% CI 10 to 15 of respondents used pure placebos while 97% (95% CI 96 to 98 used impure placebos at least once in their career. 1% of respondents used pure placebos, and 77% (95% CI 74 to 79 used impure placebos at least once per week. Most (66% for pure, 84% for impure respondents stated placebos were ethical in some circumstances. CONCLUSION AND IMPLICATIONS: Placebo use is common in primary care but questions remain about their benefits, harms, costs, and whether they can be delivered ethically. Further research is required to investigate ethically acceptable and cost-effective placebo interventions.

  12. Peripheral nervous system involvement in primary burning mouth syndrome--results of a pilot study.

    Science.gov (United States)

    Puhakka, A; Forssell, H; Soinila, S; Virtanen, A; Röyttä, M; Laine, M; Tenovuo, O; Teerijoki-Oksa, T; Jääskeläinen, S K

    2016-05-01

    The pathophysiology of primary burning mouth syndrome (BMS) has remained enigmatic, but recent studies suggest pathology within the nervous system at multiple levels. This study aimed to investigate in detail the contribution of either focal or generalized alterations within the peripheral nervous system (PNS) in the etiopathogenesis of BMS. Intraepithelial nerve fiber density (IENFD) of tongue mucosa was assessed in 10 carefully characterized BMS, and the results were compared to 19 age- and gender-matched cadaver controls, 6 with lifetime diabetes. Extensive neurophysiologic and psychophysical examinations of the trigeminal system and distal extremities were performed to profile PNS function in BMS. Patients with BMS had significantly fewer intraepithelial nerve fibers (0,27, s.e. 0,18 mm(-1); P = 0.0253) than non-diabetic controls (0,92, s.e. 0,15 mm(-1)). In the subepithelial space, the amount of nerve fibers did not differ between the groups. The majority (9/10) of patients with BMS showed neurophysiologic or psychophysical signs of a more generalized PNS dysfunction. Our results in neurophysiologically optimally characterized BMS patients confirm that pure focal small fiber neuropathy of the oral mucosa has a role in the pathophysiology of primary BMS. Furthermore, BMS may be related to a more generalized, yet subclinical peripheral neuropathy. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  13. Extracting gluino endpoints with event topology patterns

    Energy Technology Data Exchange (ETDEWEB)

    Pietsch, N. [Hamburg Univ. (Germany). Inst. fuer Experimentalphysik; Reuter, J.; Sakurai, K.; Wiesler, D. [Deutsches Elektronen-Synchrotron (DESY), Hamburg (Germany)

    2012-06-15

    In this paper we study the gluino dijet mass edge measurement at the LHC in a realistic situation including both SUSY and combinatorical backgrounds together with effects of initial and final state radiation as well as a finite detector resolution. Three benchmark scenarios are examined in which the dominant SUSY production process and also the decay modes are different. Several new kinematical variables are proposed to minimize the impact of SUSY and combinatorial backgrounds in the measurement. By selecting events with a particular number of jets and leptons, we attempt to measure two distinct gluino dijet mass edges originating from wino g {yields} jjW and bino g {yields}jjB decay modes, separately. We determine the endpoints of distributions of proposed and existing variables and show that those two edges can be disentangled and measured within good accuracy, irrespective of the presence of ISR, FSR, and detector effects.

  14. Satisfactory Results of the Exeter Revision Femoral Stem Used for Primary Total Hip Arthroplasty.

    Science.gov (United States)

    Desy, Nicholas M; Johnson, Joshua D; Sierra, Rafael J

    2017-02-01

    The Exeter cemented femoral stem has demonstrated excellent clinical and radiographic outcomes as well as long-term survivorship free from aseptic loosening. A shorter revision stem (125 mm) with a 44 offset became available for the purpose of cement-in-cement revision situations. In certain cases, this shorter revision stem may be used for various primary total hip arthroplasties (THAs) where the standard length stem would require distally reaming the femoral canal. We sought to report on the early to midterm results of this specific stem when used for primary THA regarding (1) clinical and radiographic outcomes, (2) complications, and (3) survivorship. Twenty-nine patients (33 hips) underwent a hybrid THA using the smaller revision Exeter cemented femoral stem. Twenty-five patients (28 hips) had at least 2 years of follow-up and were assessed for clinical and radiographic outcomes. All 33 hips were included in the analysis of complications and survivorship. The Kaplan-Meier survivorship was performed using revision for all causes and for aseptic loosening as the end points. The average clinical follow-up was 4 years (range, 2-7). Harris Hip Scores improved from a mean preoperative value of 56 (range, 23-96) to 90 (range, 51-100) at the latest follow-up. All patients demonstrated superior cement mantles with no signs of loosening. One patient suffered a B2 periprosthetic fracture and 1 patient experienced 2 episodes of instability. The 5-year Kaplan-Meier survivorship was 96.7% for all causes of revision and was 100% using aseptic loosening as the end point. The shorter Exeter revision cemented femoral stem has favorable early to midterm clinical and radiographic outcomes when used for primary THA with a low complication rate and is a viable option in patients with narrow femoral canals where uncemented stem fixation is not desired. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Unilateral adrenal hyperplasia is a usual cause of primary hyperaldosteronism. Results from a Swedish screening study

    Directory of Open Access Journals (Sweden)

    Sigurjonsdottir Helga

    2012-09-01

    Full Text Available Abstract Background The existence of unilateral adrenal hyperplasia (AH has been considered a rare cause of primary hyperaldosteronism (PA. Methods In a prospective study we screened for PA in a non-selected (NSP and selected hypertensive population (SP, to define the cause of PA. We included 353 consecutive patients with hypertension; age 20 to 88 years, 165 women and 188 men, from a university-based Hypertension and Nephrology Outpatient clinics (123 SP and two primary care centres, (230 NSP from the same catch-up area. Serum aldosterone and plasma renin activity (PRA were measured and the ARR calculated. Verifying diagnostic procedure was performed in patients with both elevated aldosterone and ARR. Patients diagnosed with PA were invited for adrenal venous sampling (AVS and offered laparoscopic adrenalectomy when AVS found the disease to be unilateral. Results After screening, 46 patients, 13% of the whole population (22.8% SP and 7.8% NSP had aldosterone and ARR above the locally defined cut-off limits (0.43 nmol/l and 1.28 respectively. After diagnostic verification, 20 patients (6% had PA, (14.5% SP and 1.4% NSP. Imaging diagnostic procedures with CT-scans and scintigraphy were inconclusive. AVS, performed in 15 patients verified bilateral disease in 4 and unilateral in 10 patients. One AVS failed. After laparoscopic adrenalectomy, 4 patients were found to have adenoma and 5 unilateral AH. One patient denied operation. Conclusion The prevalence of PA was in agreement with previous studies. The study finds unilateral PA common and unilateral AH as half of those cases. As may be suspected PA is found in much higher frequency in specialised hypertensive units compared to primary care centers. AVS was mandatory in diagnosis of unilateral PA.

  16. Two-temperature LATE-PCR endpoint genotyping

    Directory of Open Access Journals (Sweden)

    Reis Arthur H

    2006-12-01

    Full Text Available Abstract Background In conventional PCR, total amplicon yield becomes independent of starting template number as amplification reaches plateau and varies significantly among replicate reactions. This paper describes a strategy for reconfiguring PCR so that the signal intensity of a single fluorescent detection probe after PCR thermal cycling reflects genomic composition. The resulting method corrects for product yield variations among replicate amplification reactions, permits resolution of homozygous and heterozygous genotypes based on endpoint fluorescence signal intensities, and readily identifies imbalanced allele ratios equivalent to those arising from gene/chromosomal duplications. Furthermore, the use of only a single colored probe for genotyping enhances the multiplex detection capacity of the assay. Results Two-Temperature LATE-PCR endpoint genotyping combines Linear-After-The-Exponential (LATE-PCR (an advanced form of asymmetric PCR that efficiently generates single-stranded DNA and mismatch-tolerant probes capable of detecting allele-specific targets at high temperature and total single-stranded amplicons at a lower temperature in the same reaction. The method is demonstrated here for genotyping single-nucleotide alleles of the human HEXA gene responsible for Tay-Sachs disease and for genotyping SNP alleles near the human p53 tumor suppressor gene. In each case, the final probe signals were normalized against total single-stranded DNA generated in the same reaction. Normalization reduces the coefficient of variation among replicates from 17.22% to as little as 2.78% and permits endpoint genotyping with >99.7% accuracy. These assays are robust because they are consistent over a wide range of input DNA concentrations and give the same results regardless of how many cycles of linear amplification have elapsed. The method is also sufficiently powerful to distinguish between samples with a 1:1 ratio of two alleles from samples comprised of

  17. Cost effectiveness of interventions for lateral epicondylitis - Results from a randomised controlled trial in primary care

    DEFF Research Database (Denmark)

    Korthals-de Bos, I.B.C.; Smidt, N.; van Tulder, M.W.

    2004-01-01

    Objective: Lateral epicondylitis is a common complaint, with an annual incidence between 1% and 3% in the general population. The Dutch College of General Practitioners in The Netherlands has issued guidelines that recommend a wait- and-see policy. However, these guidelines are not evidence based....... Design and setting: This paper presents the results of an economic evaluation in conjunction with a randomised controlled trial to evaluate the effects of three interventions in primary care for patients with lateral epicondylitis. Patients and interventions: Patients with pain at the lateral side...... versus the wait- and-see policy. Conclusions: The results of this economic evaluation provided no reason to update or amend the Dutch guidelines for GPs, which recommend a wait-and-see policy for patients with lateral epicondylitis....

  18. Nanocrystalline diamond surfaces for adhesion and growth of primary neurons, conflicting results and rational explanation

    Directory of Open Access Journals (Sweden)

    Silviya Mikhailovna Ojovan

    2014-06-01

    Full Text Available Using a variety of proliferating cell types, it was shown that the surface of nanocrystalline-diamond (NCD provides a permissive substrate for cell adhesion and development without the need of complex chemical functionalization prior to cell seeding. In an extensive series of experiments we found that, unlike proliferating cells, post-mitotic primary neurons do not adhere to bare NCD surfaces when cultured in defined medium. These observations raise questions on the potential use of bare NCD as an interfacing layer for neuronal devices. Nevertheless, we also found that classical chemical functionalization methods render the hostile bare NCD surfaces with adhesive properties that match those of classically functionalized substrates used extensively in biomedical research and applications. Based on the results, we propose a mechanism that accounts for the conflicting results; which on one hand claim that un-functionalized NCD provides a permissive substrate for cell adhesion and growth, while other reports demonstrate the opposite.

  19. Long term results of primary radiation therapy for squamous cancer of the base of tongue

    International Nuclear Information System (INIS)

    Harrison, LB; Lee, H; Kraus, DH; Zelefsky, M; Strong, EW; Pfister, DG; Raben, A; Shah, J; White, C; Carper, E; Portenoy, R

    1996-01-01

    From 1981-1995, 68 patients with primary squamous cell cancer of the base of tongue were managed with primary radiation therapy, with neck dissection added for those who presented with palpable lymph node metastases. Ages ranged from 35-77 (median 55). There were 59 males and 9 females. T Stage was: T1-17, T2-32, T3-17, T4-2. Fifty-eight patients (85%) presented with nodal metastases. Treatment generally involved external beam radiation (EBRT) to the primary site and upper neck (54 Gy), low neck (50 Gy), additional EBRT to area of nodal involvement to 60 Gy, followed (2-4 weeks later) by brachytherapy boost (20-30 Gy) to the base of tongue using Iridium-192. The implant was done at the same anesthesia as the neck dissection, and all patients had temporary tracheostomy. Follow-up ranges from 1-151 months (median 36 months). Nine patients received neo-adjuvant chemotherapy. Actuarial 5 and 10-year local control is 88% and 88%, regional control is 96% and 96%, distant metastasis free survival is 91% and 76%, disease free survival is 80% and 67%, and overall survival is 86% and 52%, respectively. After EBRT, 78% of dissected necks were pathologically negative. Complications occurred in 16%. A detailed quality of life (QOL) assessment has been completed on the first 36 patients with a minimum follow-up of 3 years, and median follow-up of 5 years. This included a Performance Status Assessment, socio-demographic and economic questionnaire, a multidimensional QOL assessment measuring emotional, physical, social and functional well-being, and the Memorial Symptom Assessment Scale. This data will be presented. The overwhelming majority of patients were able to maintain their pre-diagnosis earning potential, employment status, speaking ability and ability to eat in public. However, a variety of symptoms such as xerostomia, swallowing difficulty, decreased energy, changes in taste and dietary restrictions were observed. Our data shows that primary radiation therapy produces

  20. Screening of Dementia in Portuguese Primary Care: Methodology, Assessment Tools, and Main Results

    Directory of Open Access Journals (Sweden)

    Laetitia Teixeira

    2017-11-01

    Full Text Available The objectives of this article are as follows: (1 to describe the assessment protocol used to outline people with probable dementia in Primary Health Care; (2 to show the methodological design and procedure to obtain a representative sample of patients with probable dementia; and (3 to report the main characteristics of the sample collected in the context of the study “Characteristics and needs of people with probable dementia.” The study protocol was based on the “Community Assessment of Risk and Treatment Strategies (CARTS Program” and is composed by a set of instruments that allow the assessment of older adults with probable dementia in several areas (health, psychological, functionality, and other. Descriptive analysis was used to characterize the final sample (n = 436. The study protocol as well as the methodological procedure to obtain the referral of research participants and data collection on the condition of people with probable dementia in Primary Health Care proved to be a valuable tool to obtain a sample of patients distributed by the full range of probable dementia in a large geographical area. Results may allocate the design of care pathways for old people with cognitive disorders to prevent, delay impairment, and/or optimize quality of life of patients.

  1. Primary experimental results of wire-array Z-pinches on PTS

    Energy Technology Data Exchange (ETDEWEB)

    Huang, X. B., E-mail: caephxb2003@aliyun.com; Zhou, S. T., E-mail: caephxb2003@aliyun.com; Ren, X. D., E-mail: caephxb2003@aliyun.com; Dan, J. K., E-mail: caephxb2003@aliyun.com; Wang, K. L., E-mail: caephxb2003@aliyun.com; Zhang, S. Q., E-mail: caephxb2003@aliyun.com; Li, J., E-mail: caephxb2003@aliyun.com; Xu, Q., E-mail: caephxb2003@aliyun.com; Cai, H. C., E-mail: caephxb2003@aliyun.com; Duan, S. C., E-mail: caephxb2003@aliyun.com; Ouyang, K., E-mail: caephxb2003@aliyun.com; Chen, G. H., E-mail: caephxb2003@aliyun.com; Ji, C., E-mail: caephxb2003@aliyun.com; Wang, M., E-mail: caephxb2003@aliyun.com; Feng, S. P., E-mail: caephxb2003@aliyun.com; Yang, L. B., E-mail: caephxb2003@aliyun.com; Xie, W. P., E-mail: caephxb2003@aliyun.com; Deng, J. J., E-mail: caephxb2003@aliyun.com [Key Lab of Pulsed Power, Institute of Fluid Physics, CAEP, P.O. Box 919-108, Mianyang, Sichuan 621999 (China)

    2014-12-15

    The Primary Test Stand (PTS) developed at the China Academy of Engineering Physics is a multiterawatt pulsed power driver, which can deliver a ∼10 MA, 70 ns rise-time (10%-90%) current to a short circuit load and has important applications in Z-pinch driven inertial confinement fusion and high energy density physics. In this paper, primary results of tungsten wire-array Z-pinch experiments on PTS are presented. The load geometries investigated include 15-mm-tall cylindrical single and nested arrays with diameter ranging from 14.4-26.4 mm, and consisting of 132∼276 tungsten wires with 5∼10 μm in diameter. Multiple diagnostics were fielded to determine the characteristics of x-ray radiations and to obtain self-emitting images of imploding plasmas. X-ray power up to 80 TW with ∼3 ns FWMH is achieved by using nested wire arrays. The total x-ray energy exceeds 500 kJ and the peak radiation temperature is about 150 eV. Typical velocity of imploding plasmas goes around 3∼5×10{sup 7} cm/s and the radial convergence ratio is between 10 and 20.

  2. Primary lymphoma of brain: results of management of a modern cohort with radiation therapy

    International Nuclear Information System (INIS)

    Laperriere, Normand J.; Cerezo, Laura; Milosevic, Michael F.; Wong, C. Shun; Patterson, Bruce; Panzarella, Tony

    1997-01-01

    Purpose: To assess the outcome and prognostic factors for patients with primary lymphoma of brain managed with radiation therapy between 1979 and 1988. Methods and materials: A retrospective review was undertaken of 49 patients referred to Princess Margaret Hospital. There were 25 males and 24 females. Median age was 60 years, with a range of 17-80 years. Tumors were located supratentorially in 35, infratentorially in 10, and both in 4 patients. Single masses were demonstrated on CT brain in 36, and multiple lesions in 13 patients. Cranial irradiation was given in 48, and 11 patients received chemotherapy. All patients in this series were immunocompetent. Results: Over a follow-up range of 3-11 years of surviving patients, with a median of 6 years, (40(49)) patients have died. Overall median survival was 1.4 years (17 months) and 5-year actuarial survival was 26%. Statistical analysis revealed the following significant factors: Karnofsky performance status (KPS), age, and distribution pattern of disease on presenting CT brain. Five-year actuarial survival for patients with a KPS > 60 or 60, 5-year actuarial survival was 42% and 9%, respectively (P = 0.03); for patients with solitary or multiple lesions, 5-year actuarial survival was 30% and 15%, respectively (P = 0.04). Conclusions: We conclude that Karnofsky performance status, age, and distribution pattern on pretreatment CT of brain are significant prognostic factors in primary lymphoma of brain, and that new approaches need to be developed for these patients

  3. Laboratory results gained from cold worked type 316Ti under simulated PWR primary environment

    International Nuclear Information System (INIS)

    Devrient, B.; Kilian, R.; Koenig, G.; Widera, M.; Wermelinger, T.

    2015-01-01

    Beginning in 2005, intergranular stress corrosion cracking (IGSCC) of barrel bolts made from cold worked type 316Ti (German Material No. 1.4571 K) was observed in several S/KWU type PWRs. This mechanism was so far less understood for PWR primary conditions. Therefore an extended joint research program was launched by AREVA GmbH and VGB e.V. to clarify the specific conditions which contributed to the observed findings on barrel bolts. In the frame of this research program beneath the evaluation of the operational experience also laboratory tests on the general cracking behavior of cold worked type 316Ti material, which followed the same production line as for barrel bolt manufacturing in the eighties, with different cold work levels covering up to 30 % were performed to determine whether there is a specific susceptibility of cold worked austenitic stainless steel specimens to suffer IGSCC under simulated PWR primary conditions. All these slow strain rate tests on tapered specimens and component specimens came to the results that first, much higher cold work levels than used for the existing barrel bolts are needed for IGSCC initiation. Secondly, additional high active plastic deformation is needed to generate and propagate intergranular cracking. And thirdly, all specimens finally showed ductile fracture at the applied strain rates. (authors)

  4. First results of the wind evaluation breadboard for ELT primary mirror design

    Science.gov (United States)

    Reyes García-Talavera, Marcos; Viera, Teodora; Núñez, Miguel

    2010-07-01

    The Wind Evaluation Breadboard (WEB) is a primary mirror and telescope simulator formed by seven aluminium segments, including position sensors, electromechanical support systems and support structures. WEB has been developed to evaluate technologies for primary mirror wavefront control and to evaluate the performance of the control of wind buffeting disturbance on ELT segmented mirrors. For this purpose WEB electro-mechanical set-up simulates the real operational constrains applied to large segmented mirrors. This paper describes the WEB assembly, integration and verification, the instrument characterisation and close loop control design, including the dynamical characterization of the instrument and the control architecture. The performance of the new technologies developed for position sensing, acting and controlling is evaluated. The integration of the instrument in the observatory and the results of the first experiments are summarised, with different wind conditions, elevation and azimuth angles of incidence. Conclusions are extracted with respect the wind rejection performance and the control strategy for an ELT. WEB has been designed and developed by IAC, ESO, ALTRAN and JUPASA, with the integration of subsystems of FOGALE and TNO.

  5. Exposing the cancer genome atlas as a SPARQL endpoint.

    Science.gov (United States)

    Deus, Helena F; Veiga, Diogo F; Freire, Pablo R; Weinstein, John N; Mills, Gordon B; Almeida, Jonas S

    2010-12-01

    The Cancer Genome Atlas (TCGA) is a multidisciplinary, multi-institutional effort to characterize several types of cancer. Datasets from biomedical domains such as TCGA present a particularly challenging task for those interested in dynamically aggregating its results because the data sources are typically both heterogeneous and distributed. The Linked Data best practices offer a solution to integrate and discover data with those characteristics, namely through exposure of data as Web services supporting SPARQL, the Resource Description Framework query language. Most SPARQL endpoints, however, cannot easily be queried by data experts. Furthermore, exposing experimental data as SPARQL endpoints remains a challenging task because, in most cases, data must first be converted to Resource Description Framework triples. In line with those requirements, we have developed an infrastructure to expose clinical, demographic and molecular data elements generated by TCGA as a SPARQL endpoint by assigning elements to entities of the Simple Sloppy Semantic Database (S3DB) management model. All components of the infrastructure are available as independent Representational State Transfer (REST) Web services to encourage reusability, and a simple interface was developed to automatically assemble SPARQL queries by navigating a representation of the TCGA domain. A key feature of the proposed solution that greatly facilitates assembly of SPARQL queries is the distinction between the TCGA domain descriptors and data elements. Furthermore, the use of the S3DB management model as a mediator enables queries to both public and protected data without the need for prior submission to a single data source. Copyright © 2010 Elsevier Inc. All rights reserved.

  6. Endpoint behavior of the pion distribution amplitude in QCD sum rules with nonlocal condensates

    International Nuclear Information System (INIS)

    Mikhailov, S. V.; Pimikov, A. V.; Stefanis, N. G.

    2010-01-01

    Starting from the QCD sum rules with nonlocal condensates for the pion distribution amplitude, we derive another sum rule for its derivative and its ''integral derivatives''--defined in this work. We use this new sum rule to analyze the fine details of the pion distribution amplitude in the endpoint region x∼0. The results for endpoint-suppressed and flattop (or flatlike) pion distribution amplitudes are compared with those we obtained with differential sum rules by employing two different models for the distribution of vacuum-quark virtualities. We determine the range of values of the derivatives of the pion distribution amplitude and show that endpoint-suppressed distribution amplitudes lie within this range, while those with endpoint enhancement--flat-type or Chernyak-Zhitnitsky like--yield values outside this range.

  7. SALT segmented primary mirror: laboratory test results for FOGALE inductive edge sensors

    Science.gov (United States)

    Menzies, John; Gajjar, Hitesh; Buous, Sébastien; Buckley, David; Gillingham, Peter

    2010-07-01

    At the Southern African Large Telescope (SALT), in collaboration with FOGALE Nanotech, we have been testing the recently-developed new generation inductive edge sensors. The Fogale inductive sensor is one technology being evaluated as a possible replacement for the now defunct capacitance-based edge sensing system. We present the results of exhaustive environmental testing of two variants of the inductive sensor. In addition to the environmental testing including RH and temperature cycles, the sensor was tested for sensitivity to dust and metals. We also consider long-term sensor stability, as well as that of the electronics and of the glue used to bond the sensor to its supporting structure. A prototype design for an adjustable mount is presented which will allow for in-plane gap and shear variations present in the primary mirror configuration without adversely disturbing the figure of the individual mirror segments or the measurement accuracy.

  8. Primary progressive aphasia patients evaluated using diffusion tensor imaging and voxel based volumetry-preliminary results

    Directory of Open Access Journals (Sweden)

    Fábio Pascotto de Oliveira

    2011-06-01

    Full Text Available There are individuals who have a progressive language deficit without presenting cognitive deficits in other areas. One of the diseases related to this presentation is primary progressive aphasia (PPA. OBJECTIVE: Identify by means of diffusion tensor imaging (DTI and measurements of cortical volume, brain areas that lead to dysphasia when presenting signs of impaired connectivity or reduced volume. METHOD: Four patients with PPA were evaluated using DTI, and measurements of cortical volumes in temporal areas. These patients were compared with two normal volunteers. RESULTS: There is a trend to a difference in the number and volume of related fibers between control group and patients with PPA. Comparing cortical volumes in temporal areas between groups yielded a trend to a smaller volume in PPA patients. CONCLUSION: Patients with PPA have a trend to impairment in cortical and subcortical levels regarding relevant areas.

  9. Subtotal parathyroidectomy for primary hyperparathyroidism. Long-term results in 292 patients

    International Nuclear Information System (INIS)

    Paloyan, E.; Lawrence, A.M.; Oslapas, R.; Shah, K.H.; Ernst, K.; Hofmann, C.

    1983-01-01

    Subtotal parathyroidectomy was performed in a consecutive series of 292 patients with primary hyperparathyroidism. We evaluated the long-term postoperative results during a period of 16 years. Patients ranged in age from 14 to 83 years and included 176 women and 116 men. Of these, 16% had a history of exposure to radiation in childhood or adolescence, while thyroid disease requiring some form of thyroidectomy coexisted in 91 (31%) of the patients. Histologic information on three or more parathyroid glands was obtained in 73% of the cases. We considered 285 patients (97.6%) cured after their first operation. The remaining seven patients (2.4%) had persistent hyperparathyroidism. However, five were cured after a sternum-splitting mediastinal exploration and one after a second neck exploration. The seventh remains hypercalcemic despite a subsequent mediastinal exploration. Temporary postoperative hypoparathyroidism occurred in 10% of our cases and permanent hypoparathyroidism in 1%. There have been no instances of recurrent hyperparathyroidism

  10. Correlation of analysis with high level vibration test results for primary coolant piping

    International Nuclear Information System (INIS)

    Park, Y.J.; Hofmayer, C.H.; Costello, J.F.

    1992-01-01

    Dynamic tests on a modified 1/2.5-scale model of pressurized water reactor (PWR) primary coolant piping were performed using a large shaking table at Tadotsu, Japan. The High Level Vibration Test (HLVT) program was part of a cooperative study between the United States (Nuclear Regulatory Commission/Brookhaven National Laboratory, NRC/BNL) and Japan (Ministry of International Trade and Industry/Nuclear Power Engineering Center). During the test program, the excitation level of each test run was gradually increased up to the limit of the shaking table and significant plastic strains, as well as cracking, were induced in the piping. To fully utilize the test results, NRC/BNL sponsored a project to develop corresponding analytical predictions for the nonlinear dynamic response of the piping for selected test runs. The analyses were performed using both simplified and detailed approaches. The simplified approaches utilize a linear solution and an approximate formulation for nonlinear dynamic effects such as the use of a deamplification factor. The detailed analyses were performed using available nonlinear finite element computer codes, including the MARC, ABAQUS, ADINA and WECAN codes. A comparison of various analysis techniques with the test results shows a higher prediction error in the detailed strain values in the overall response values. A summary of the correlation analyses was presented before the BNL. This paper presents a detailed description of the various analysis results and additional comparisons with test results

  11. Test result communication in primary care: a survey of current practice.

    Science.gov (United States)

    Litchfield, Ian; Bentham, Louise; Lilford, Richard; McManus, Richard J; Hill, Ann; Greenfield, Sheila

    2015-11-01

    The number of blood tests ordered in primary care continues to increase and the timely and appropriate communication of results remains essential. However, the testing and result communication process includes a number of participants in a variety of settings and is both complicated to manage and vulnerable to human error. In the UK, guidelines for the process are absent and research in this area is surprisingly scarce; so before we can begin to address potential areas of weakness there is a need to more precisely understand the strengths and weaknesses of current systems used by general practices and testing facilities. We conducted a telephone survey of practices across England to determine the methods of managing the testing and result communication process. In order to gain insight into the perspectives from staff at a large hospital laboratory we conducted paired interviews with senior managers, which we used to inform a service blueprint demonstrating the interaction between practices and laboratories and identifying potential sources of delay and failure. Staff at 80% of practices reported that the default method for communicating normal results required patients to telephone the practice and 40% of practices required that patients also call for abnormal results. Over 80% had no fail-safe system for ensuring that results had been returned to the practice from laboratories; practices would otherwise only be aware that results were missing or delayed when patients requested results. Persistent sources of missing results were identified by laboratory staff and included sample handling, misidentification of samples and the inefficient system for collating and resending misdirected results. The success of the current system relies on patients both to retrieve results and in so doing alert staff to missing and delayed results. Practices appear slow to adopt available technological solutions despite their potential for reducing the impact of recurring errors in the

  12. Implementing a stepped-care approach in primary care: results of a qualitative study

    Directory of Open Access Journals (Sweden)

    Franx Gerdien

    2012-01-01

    Full Text Available Abstract Background Since 2004, 'stepped-care models' have been adopted in several international evidence-based clinical guidelines to guide clinicians in the organisation of depression care. To enhance the adoption of this new treatment approach, a Quality Improvement Collaborative (QIC was initiated in the Netherlands. Methods Alongside the QIC, an intervention study using a controlled before-and-after design was performed. Part of the study was a process evaluation, utilizing semi-structured group interviews, to provide insight into the perceptions of the participating clinicians on the implementation of stepped care for depression into their daily routines. Participants were primary care clinicians, specialist clinicians, and other healthcare staff from eight regions in the Netherlands. Analysis was supported by the Normalisation Process Theory (NPT. Results The introduction of a stepped-care model for depression to primary care teams within the context of a depression QIC was generally well received by participating clinicians. All three elements of the proposed stepped-care model (patient differentiation, stepped-care treatment, and outcome monitoring, were translated and introduced locally. Clinicians reported changes in terms of learning how to differentiate between patient groups and different levels of care, changing antidepressant prescribing routines as a consequence of having a broader treatment package to offer to their patients, and better working relationships with patients and colleagues. A complex range of factors influenced the implementation process. Facilitating factors were the stepped-care model itself, the structured team meetings (part of the QIC method, and the positive reaction from patients to stepped care. The differing views of depression and depression care within multidisciplinary health teams, lack of resources, and poor information systems hindered the rapid introduction of the stepped-care model. The NPT

  13. Antihypertensive combination therapy in primary care offices: results of a cross-sectional survey in Switzerland

    Directory of Open Access Journals (Sweden)

    Roas S

    2014-12-01

    Full Text Available Susanne Roas,1 Felix Bernhart,2 Michael Schwarz,3 Walter Kaiser,4 Georg Noll5 1Department of Internal Medicine, University Hospital, Zurich, 2Private Practice, Biberist, 3Ambulatorium Wiesendamm, Basel, 4Healthworld (Schweiz AG, Steinhausen, 5HerzKlinik Hirslanden, Zurich, Switzerland Background: Most hypertensive patients need more than one substance to reach their target blood pressure (BP. Several clinical studies indicate the high efficacy of antihypertensive combinations, and recent guidelines recommend them in some situations even as initial therapies. In general practice they seem widespread, but only limited data are available on their effectiveness under the conditions of everyday life. The objectives of this survey among Swiss primary care physicians treating hypertensive patients were: to know the frequency of application of different treatment modalities (monotherapies, free individual combinations, single-pill combinations; to see whether there are relationships between prescribed treatment modalities and patient characteristics, especially age, treatment duration, and comorbidities; and to determine the response rate (percentage of patients reaching target BP of different treatment modalities under the conditions of daily practice. Methods: This cross-sectional, observational survey among 228 randomly chosen Swiss primary care physicians analyzed data for 3,888 consecutive hypertensive patients collected at one single consultation. Results: In this survey, 31.9% of patients received monotherapy, 41.2% two substances, 20.9% three substances, and 4.7% more than three substances. By combination mode, 34.9% took free individual combinations and 30.0% took fixed-dose single-pill combinations. Combinations were more frequently given to older patients with a long history of hypertension and/or comorbidities. In total, 67.8% of patients achieved their BP target according to their physician's judgment. When compared, single

  14. Diagnosing cancer in primary care: results from the National Cancer Diagnosis Audit

    Science.gov (United States)

    Swann, Ruth; McPhail, Sean; Witt, Jana; Shand, Brian; Abel, Gary A; Hiom, Sara; Rashbass, Jem; Lyratzopoulos, Georgios; Rubin, Greg

    2018-01-01

    Background Continual improvements in diagnostic processes are needed to minimise the proportion of patients with cancer who experience diagnostic delays. Clinical audit is a means of achieving this. Aim To characterise key aspects of the diagnostic process for cancer and to generate baseline measures for future re-audit. Design and setting Clinical audit of cancer diagnosis in general practices in England. Method Information on patient and tumour characteristics held in the English National Cancer Registry was supplemented by information from GPs in participating practices. Data items included diagnostic timepoints, patient characteristics, and clinical management. Results Data were collected on 17 042 patients with a new diagnosis of cancer during 2014 from 439 practices. Participating practices were similar to non-participating ones, particularly regarding population age, urban/rural location, and practice-based patient experience measures. The median diagnostic interval for all patients was 40 days (interquartile range [IQR] 15–86 days). Most patients were referred promptly (median primary care interval 5 days [IQR 0–27 days]). Where GPs deemed diagnostic delays to have occurred (22% of cases), patient, clinician, or system factors were responsible in 26%, 28%, and 34% of instances, respectively. Safety netting was recorded for 44% of patients. At least one primary care-led investigation was carried out for 45% of patients. Most patients (76%) had at least one existing comorbid condition; 21% had three or more. Conclusion The findings identify avenues for quality improvement activity and provide a baseline for future audit of the impact of 2015 National Institute for Health and Care Excellence guidance on management and referral of suspected cancer. PMID:29255111

  15. Multicenter results of stereotactic body radiotherapy (SBRT) for non-resectable primary liver tumors

    Energy Technology Data Exchange (ETDEWEB)

    Ibarra, Rafael A.; Rojas, Daniel; Sanabria, Juan R. [Dept. of Surgery, Univ. Hospitals-Case Medical Center, Cleveland, OH (United States)], email: juan.sanabria@uhhospitals.org [and others

    2012-05-15

    Background. An excess of 100 000 individuals are diagnosed with primary liver tumors every year in USA but less than 20% of those patients are amenable to definitive surgical management due to advanced local disease or comorbidities. Local therapies to arrest tumor growth have limited response and have shown no improvement on patient survival. Stereotactic body radiotherapy (SBRT) has emerged as an alternative local ablative therapy. The purpose of this study was to evaluate the tumor response to SBRT in a combined multicenter database. Study design. Patients with advanced hepatocellular carcinoma (HCC, n = 21) or intrahepatic cholangiocarcinoma (ICC, n = 11) treated with SBRT from four Academic Medical Centers were entered into a common database. Statistical analyses were performed for freedom from local progression (FFLP) and patient survival. Results. The overall FFLP for advanced HCC was 63% at a median follow-up of 12.9 months. Median tumor volume decreased from 334.2 to 135 cm{sup 3} (p < 0.004). The median time to local progression was 6.3 months. The 1- and 2-years overall survival rates were 87% and 55%, respectively. Patients with ICC had an overall FFLP of 55.5% at a median follow-up of 7.8 months. The median time to local progression was 4.2 months and the six-month and one-year overall survival rates were 75% and 45%, respectively. The incidence of grade 1-2 toxicities, mostly nausea and fatigue, was 39.5%. Grade 3 and 4 toxicities were present in two and one patients, respectively. Conclusion. Higher rates of FFLP were achieved by SBRT in the treatment of primary liver malignancies with low toxicity.

  16. Methodology and results of a space station education pilot programme in the primary school

    Science.gov (United States)

    Mirra, G.; Mirra, C.

    Potential users of the Space Station Freedom are now still in the Primary School. Subject studies 1 have shown that a robust familiarization programme has to be developed in order to increase public awareness on the microgravity environment and its capabilities to perform unique science. At the same time, several surveys 2 have demonstrated that elementary school students are showing the greatest interest and enthusiasm in space related activities among all school students. With these boundary conditions, a pilot programme, aimed at verifying the capabilities of young primary school pupils (aged between 10 and 12) in understanding why one performs research in space, has been conceived. In order to overcome the lack of space training of school teachers, an expert in space operations joined a group of elementary teachers to activate this program: merging the necessary didactic and technical capabilities. Consequently, the aim of the program becomes two folded: •generate critical thinking and problem solving capacities as well as inventiveness in children making them aware on the use of space to improve life on Earth. •identify the key issues for the definition of a robust space utilization educational programme. The programme has been managed by MARS Center. the Italian User Support Center for the Space Station utilization, and the institute "Speranzas" in the nearby of Naples, Italy. MARS Center, in particular, is responsible towards the national agency ASI, Agenzia Spaziale Italiana, of the execution of the promotional activity towards all the possible target groups: young students are among these groups. This programme started in late 1992 and is currently ongoing. The objective of this paper is to provide a description of the methodology and the reasons of such a programme with a snapshot on the preliminary results and future trends. Means used as supporting tools, such as films, posters and role plays are herein depicted as well as statistics on the pupils

  17. Endpoint distinctiveness facilitates analogical mapping in pigeons.

    Science.gov (United States)

    Hagmann, Carl Erick; Cook, Robert G

    2015-03-01

    Analogical thinking necessitates mapping shared relations across two separate domains. We investigated whether pigeons could learn faster with ordinal mapping of relations across two physical dimensions (circle size & choice spatial position) relative to random mapping of these relations. Pigeons were trained to relate six circular samples of different sizes to horizontally positioned choice locations in a six alternative matching-to-sample task. Three pigeons were trained in a mapped condition in which circle size mapped directly onto choice spatial position. Three other pigeons were trained in a random condition in which the relations between size and choice position were arbitrarily assigned. The mapped group showed an advantage over the random group in acquiring this task. In a subsequent second phase, relations between the dimensions were ordinally reversed for the mapped group and re-randomized for the random group. There was no difference in how quickly matching accuracy re-emerged in the two groups, although the mapped group eventually performed more accurately. Analyses suggested this mapped advantage was likely due to endpoint distinctiveness and the benefits of proximity errors during choice responding rather than a conceptual or relational advantage attributable to the common or ordinal mapping of the two dimensions. This potential difficulty in mapping relations across dimensions may limit the pigeons' capacity for more advanced types of analogical reasoning. This article is part of a Special Issue entitled: Tribute to Tom Zentall. Copyright © 2014 Elsevier B.V. All rights reserved.

  18. Endpoint Distinctiveness Facilitates Analogical Mapping in Pigeons

    Science.gov (United States)

    Hagmann, Carl Erick; Cook, Robert G.

    2015-01-01

    Analogical thinking necessitates mapping shared relations across two separate domains. We investigated whether pigeons could learn faster with ordinal mapping of relations across two physical dimensions (circle size & choice spatial position) relative to random mapping of these relations. Pigeons were trained to relate six circular samples of different sizes to horizontally positioned choice locations in a six alternative matching-to-sample task. Three pigeons were trained in a mapped condition in which circle size mapped directly onto choice spatial position. Three other pigeons were trained in a random condition in which the relations between size and choice position were arbitrarily assigned. The mapped group showed an advantage over the random group in acquiring this task. In a subsequent second phase, reassignment, relations between the dimensions were ordinally reversed for the mapped group and re-randomized for the random group. There was no difference in how quickly matching accuracy re-emerged in the two groups, although the mapped group eventually performed more accurately. Analyses suggested this mapped advantage was likely due endpoint distinctiveness and the benefits of proximity errors during choice responding rather than a conceptual or relational advantage attributable to the common or ordinal map of the two dimensions. This potential difficulty in mapping relations across dimensions may limit the pigeons’ capacity for more advanced types of analogical reasoning. PMID:25447511

  19. Factors associated with professional satisfaction in primary care: Results from EUprimecare project.

    Science.gov (United States)

    Sanchez-Piedra, Carlos Alberto; Jaruseviciene, Lina; Prado-Galbarro, Francisco Javier; Liseckiene, Ida; Sánchez-Alonso, Fernando; García-Pérez, Sonia; Sarria Santamera, Antonio

    2017-12-01

    Given the importance of primary care to healthcare systems and population health, it seems crucial to identify factors that contribute to the quality of primary care. Professional satisfaction has been linked with quality of primary care. Physician dissatisfaction is considered a risk factor for burnout and leaving medicine. This study explored factors associated with professional satisfaction in seven European countries. A survey was conducted among primary care physicians. Estonia, Finland, Germany and Hungary used a web-based survey, Italy and Lithuania a telephone survey, and Spain face to face interviews. Sociodemographic information (age, sex), professional experience and qualifications (years since graduation, years of experience in general practice), organizational variables related to primary care systems and satisfaction were included in the final version of the questionnaire. A logistic regression analysis was performed to assess the factors associated with satisfaction among physicians. A total of 1331 primary care physicians working in primary care services responded to the survey. More than half of the participants were satisfied with their work in primary care services (68.6%). We found significant associations between satisfaction and years of experience (OR = 1.01), integrated network of primary care centres (OR = 2.8), patients having direct access to specialists (OR = 1.3) and professionals having access to data on patient satisfaction (OR = 1.3). Public practice, rather than private practice, was associated with lower primary care professional satisfaction (OR = 0.8). Elements related to the structure of primary care are associated with professional satisfaction. At the individual level, years of experience seems to be associated with higher professional satisfaction.

  20. Learning to Teach Geography for Primary Education: Results of an Experimental Programme

    Science.gov (United States)

    Blankman, Marian; Schoonenboom, Judith; van der Schee, Joop; Boogaard, Marianne; Volman, Monique

    2016-01-01

    Students training to become primary school teachers appear to have little awareness of the core concepts of geography (teaching). To ensure that future primary school teachers are able to develop their pupils' geographical awareness, a six weeks programme was developed. The characteristics of this programme -- named Consciously Teaching Geography…

  1. Learning to teach geography for primary education : Results of an experimental programme

    NARCIS (Netherlands)

    Blankman, M.; Schoonenboom, J.; van der Schee, J.; Boogaard, M.; Volman, M.

    2016-01-01

    Students training to become primary school teachers appear to have little awareness of the core concepts of geography (teaching). To ensure that future primary school teachers are able to develop their pupils’ geographical awareness, a six weeks programme was developed. The characteristics of this

  2. Pediatric Primary Care Providers' Relationships with Mental Health Care Providers: Survey Results

    Science.gov (United States)

    Pidano, Anne E.; Honigfeld, Lisa; Bar-Halpern, Miri; Vivian, James E.

    2014-01-01

    Background: As many as 20 % of children have diagnosable mental health conditions and nearly all of them receive pediatric primary health care. However, most children with serious mental health concerns do not receive mental health services. This study tested hypotheses that pediatric primary care providers (PPCPs) in relationships with mental…

  3. Preliminary experimental results of tungsten wire-array Z-pinches on primary test stand

    Energy Technology Data Exchange (ETDEWEB)

    Huang, Xian-Bin; Zhou, Shao-Tong; Dan, Jia-Kun; Ren, Xiao-Dong, E-mail: amosrxd@163.com; Wang, Kun-Lun; Zhang, Si-Qun; Li, Jing; Xu, Qiang; Cai, Hong-Chun; Duan, Shu-Chao; Ouyang, Kai; Chen, Guang-Hua; Ji, Ce; Wei, Bing; Feng, Shu-Ping; Wang, Meng; Xie, Wei-Ping; Deng, Jian-Jun [Key Laboratory of Pulsed Power, Institute of Fluid Physics, China Academy of Engineering Physics, P.O. Box 919-108, Mianyang, Sichuan 621999 (China); Zhou, Xiu-Wen; Yang, Yi [Research Center of Laser Fusion, China Academy of Engineering Physics, P.O. Box 919-987, Mianyang, Sichuan 621999 (China)

    2015-07-15

    The Primary Test Stand (PTS) developed at the China Academy of Engineering Physics is a 20 TW pulsed power driver, which can deliver a ∼10 MA, 70 ns rise-time (10%–90%) current to a short-circuit load and has important applications in Z-pinch driven inertial confinement fusion and high energy density physics. Preliminary results of tungsten wire-array Z-pinch experiments on PTS are presented. The load geometries investigated include 15-mm-tall cylindrical single and nested arrays with diameter ranging from 13 mm to 30 mm, consisting of 132–300 tungsten wires with 5–10 μm in diameter. Multiple diagnostics were fielded to characterize the x-ray radiation from wire-array Z pinches. The x-ray peak power (∼50 TW) and total radiated energy (∼500 kJ) were obtained from a single 20-mm-diam array with 80-ns stagnation time. The highest x-ray peak power up to 80 TW with 2.4 ns FWHM was achieved by using a nested array with 20-mm outer diameter, and the total x-ray energy from the nested array is comparable to that of single array. Implosion velocity estimated from the time-resolved image measurement exceeds 30 cm/μs. The detailed experimental results and other findings are presented and discussed.

  4. Results of combined modality treatment in patients with primary unresectable cancer of the oral cavity

    International Nuclear Information System (INIS)

    Kawecki, A.; Starosciak, S.; Towpik, E.; Jagielska, B.; Lenartowicz, B.; Pietras, M.; Szutkowski, Z.; Kiprian, D.

    2001-01-01

    Neoadjuvant chemotherapy may improve the results of treatment for primarily unresectable cancer of the oral cavity. The aim of this study was to estimate the tolerance and early results of neoadjuvant chemotherapy followed by surgical resection of oral cavity cancer, with immediate reconstruction and adjuvant radiotherapy. 56 patients hospitalized at the Department of Head and Neck Cancer of the Maria Sklodowska-Curie Memorial Cancer Centre - Institute of Oncology between August 1997 and June 2000 were enrolled for the purpose of the study. When tumour regresion was observed after 2-4 courses of neoadjuvant chemotherapy consisting of cisplatin, 5-fluorouracil, methotrexate, vinblastin, etoposide and leucovorin, the patients were referred for surgical resection with immediate reconstruction, followed by adjuvant radiotherapy. Regression of the primary tumor and lymph nodes of the neck was observed in 41 patients, all of whom were referred for radical surgery followed by adjuvant radiotherapy. The tolerance of combined treatment was acceptable. Complete regression was obtained in 37/56 patients. During observation 12 patients failed due to locoregional progression and 2 due to distant metastases. 23/56 patients (41 %) are alive without evidence of disease. Neoadjuvant chemotherapy allows for radical resection in a majority of patients with primarily unresectable cancer of the oral cavity. The tolerance of treatment is good. What is important, radiotherapy and chemotherapy do not impair wound healing and vascularity of musculo-cutaneous island flaps

  5. Preliminary clinical results of locoregional hyperthermia for primary and secondary bone tumors

    Energy Technology Data Exchange (ETDEWEB)

    Zhu, J.L.; Nagata, Yasushi; Kanamori, Shuichi; Mitsumori, Michihide; Okuno, Yoshishige; Horii, Naotoshi; Nishimura, Yasumasa; Masunaga, Shinitiro; Hiraoka, Masahiro [Kyoto Univ. (Japan). Graduate School of Medicine

    2000-03-01

    Nineteen primary and secondary bone tumors in 16 patients were treated with hyperthermia plus radiotherapy and/or chemotherapy between 1982 and 1997 at Kyoto University Hospital. The thermometric and clinical results were analyzed retrospectively. In 55 of 86 hyperthermia sessions, the intratumor temperature was measured using a thermometer. Of the 19 tumors, 16 (84%) received heat treatment 4-7 times, and 3 (16%) received 1 or 2 treatments of hyperthermia. The mean maximum, mean minimum and average intratumor temperatures were 42.9, 40.4 and 41.6 deg C, respectively, and 12 (67%) reached a tumor maximum temperature above 42.5 deg C. The durations that intratumor points exceeded 42, 41 and 40 deg C were 27, 34 and 38 min, respectively. The local tumor response to treatment was assessed using X-ray computed tomography. The local response rate was 16% and the local pain relief rate was 63%. The 1-year cumulative survival rate was 60%. Our preliminary results indicated that thermoradiotherapy and thermochemotherapy are clinicaly feasible and potentially beneficial in the management of locally advanced bone tumors. (author)

  6. Sample size determination for equivalence assessment with multiple endpoints.

    Science.gov (United States)

    Sun, Anna; Dong, Xiaoyu; Tsong, Yi

    2014-01-01

    Equivalence assessment between a reference and test treatment is often conducted by two one-sided tests (TOST). The corresponding power function and sample size determination can be derived from a joint distribution of the sample mean and sample variance. When an equivalence trial is designed with multiple endpoints, it often involves several sets of two one-sided tests. A naive approach for sample size determination in this case would select the largest sample size required for each endpoint. However, such a method ignores the correlation among endpoints. With the objective to reject all endpoints and when the endpoints are uncorrelated, the power function is the production of all power functions for individual endpoints. With correlated endpoints, the sample size and power should be adjusted for such a correlation. In this article, we propose the exact power function for the equivalence test with multiple endpoints adjusted for correlation under both crossover and parallel designs. We further discuss the differences in sample size for the naive method without and with correlation adjusted methods and illustrate with an in vivo bioequivalence crossover study with area under the curve (AUC) and maximum concentration (Cmax) as the two endpoints.

  7. Ordered kinematic endpoints for 5-body cascade decays

    Energy Technology Data Exchange (ETDEWEB)

    Klimek, Matthew D. [Theory Group, Department of Physics and Texas Cosmology Center,University of Texas at Austin, 2515 Speedway, Stop C1608, Austin, TX, 78712 (United States)

    2016-12-23

    We present expressions for the kinematic endpoints of 5-body cascade decay chains proceeding through all possible combinations of 2-body and 3-body decays, with one stable invisible particle in the final decay stage. When an invariant mass can be formed in multiple ways by choosing different final state particles from a common vertex, we introduce techniques for finding the sub-leading endpoints for all indistinguishable versions of the invariant mass. In contrast to short decay chains, where sub-leading endpoints are linearly related to the leading endpoints, we find that in 5-body decays, they provide additional independent constraints on the mass spectrum.

  8. A step towards standardization: A method for end-point titer determination by fluorescence index of an automated microscope. End-point titer determination by fluorescence index.

    Science.gov (United States)

    Carbone, Teresa; Gilio, Michele; Padula, Maria Carmela; Tramontano, Giuseppina; D'Angelo, Salvatore; Pafundi, Vito

    2018-05-01

    Indirect Immunofluorescence (IIF) is widely considered the Gold Standard for Antinuclear Antibody (ANA) screening. However, the high inter-reader variability remains the major disadvantage associated with ANA testing and the main reason for the increasing demand of the computer-aided immunofluorescence microscope. Previous studies proposed the quantification of the fluorescence intensity as an alternative for the classical end-point titer evaluation. However, the different distribution of bright/dark light linked to the nature of the self-antigen and its location in the cells result in different mean fluorescence intensities. The aim of the present study was to correlate Fluorescence Index (F.I.) with end-point titers for each well-defined ANA pattern. Routine serum samples were screened for ANA testing on HEp-2000 cells using Immuno Concepts Image Navigator System, and positive samples were serially diluted to assign the end-point titer. A comparison between F.I. and end-point titers related to 10 different staining patterns was made. According to our analysis, good technical performance of F.I. (97% sensitivity and 94% specificity) was found. A significant correlation between quantitative reading of F.I. and end-point titer groups was observed using Spearman's test and regression analysis. A conversion scale of F.I. in end-point titers for each recognized ANA-pattern was obtained. The Image Navigator offers the opportunity to improve worldwide harmonization of ANA test results. In particular, digital F.I. allows quantifying ANA titers by using just one sample dilution. It could represent a valuable support for the routine laboratory and an effective tool to reduce inter- and intra-laboratory variability. Copyright © 2018. Published by Elsevier B.V.

  9. Relative Biological Effectiveness of HZE Particles for Chromosomal Exchanges and Other Surrogate Cancer Risk Endpoints.

    Directory of Open Access Journals (Sweden)

    Eliedonna Cacao

    Full Text Available The biological effects of high charge and energy (HZE particle exposures are of interest in space radiation protection of astronauts and cosmonauts, and estimating secondary cancer risks for patients undergoing Hadron therapy for primary cancers. The large number of particles types and energies that makeup primary or secondary radiation in HZE particle exposures precludes tumor induction studies in animal models for all but a few particle types and energies, thus leading to the use of surrogate endpoints to investigate the details of the radiation quality dependence of relative biological effectiveness (RBE factors. In this report we make detailed RBE predictions of the charge number and energy dependence of RBE's using a parametric track structure model to represent experimental results for the low dose response for chromosomal exchanges in normal human lymphocyte and fibroblast cells with comparison to published data for neoplastic transformation and gene mutation. RBE's are evaluated against acute doses of γ-rays for doses near 1 Gy. Models that assume linear or non-targeted effects at low dose are considered. Modest values of RBE (10 are predicted at low doses <0.1 Gy. The radiation quality dependence of RBE's against the effects of acute doses γ-rays found for neoplastic transformation and gene mutation studies are similar to those found for simple exchanges if a linear response is assumed at low HZE particle doses. Comparisons of the resulting model parameters to those used in the NASA radiation quality factor function are discussed.

  10. Land surface temperature downscaling using random forest regression: primary result and sensitivity analysis

    Science.gov (United States)

    Pan, Xin; Cao, Chen; Yang, Yingbao; Li, Xiaolong; Shan, Liangliang; Zhu, Xi

    2018-04-01

    The land surface temperature (LST) derived from thermal infrared satellite images is a meaningful variable in many remote sensing applications. However, at present, the spatial resolution of the satellite thermal infrared remote sensing sensor is coarser, which cannot meet the needs. In this study, LST image was downscaled by a random forest model between LST and multiple predictors in an arid region with an oasis-desert ecotone. The proposed downscaling approach was evaluated using LST derived from the MODIS LST product of Zhangye City in Heihe Basin. The primary result of LST downscaling has been shown that the distribution of downscaled LST matched with that of the ecosystem of oasis and desert. By the way of sensitivity analysis, the most sensitive factors to LST downscaling were modified normalized difference water index (MNDWI)/normalized multi-band drought index (NMDI), soil adjusted vegetation index (SAVI)/ shortwave infrared reflectance (SWIR)/normalized difference vegetation index (NDVI), normalized difference building index (NDBI)/SAVI and SWIR/NDBI/MNDWI/NDWI for the region of water, vegetation, building and desert, with LST variation (at most) of 0.20/-0.22 K, 0.92/0.62/0.46 K, 0.28/-0.29 K and 3.87/-1.53/-0.64/-0.25 K in the situation of +/-0.02 predictor perturbances, respectively.

  11. Primary prevention of cardiovascular disease in Greece: Greek results of the EURIKA study.

    Science.gov (United States)

    Elisaf, Moses; Tzouvelekis, Emmanouil; Nikas, Nikos

    2014-01-01

    The EURIKA study was designed to describe the control of cardiovascular disease (CVD) risk factors in a real-world primary prevention setting in Europe, to estimate residual CVD risk, and to assess physicians' attitudes to and perceptions of risk factor management. The present manuscript reports the EURIKA results from Greece. EURIKA was a multinational, cross-sectional study conducted in 12 European countries. Randomly selected physicians completed a questionnaire regarding their demographics and CVD prevention beliefs and practices. Consenting patients who were free of CVD, aged 50 years, and with 1 CVD risk factor, were recruited. Risk factor definition and treatment goals were based on the 2007 European guidelines on CVD prevention. Global CVD risk was estimated using the SCORE equation. In addition, each patient provided a fasting blood sample for measurement of serum lipids, and HbA1c. Overall, 620 evaluable patients (male/female 46%/54%) were enrolled by 63 physicians (13 hospital-based, 50 office-based) across Greece. Almost one-third of the patients (27.3%) were classified as highrisk (SCORE5%). Blood pressure, dyslipidaemia and diabetes were controlled in 47.5%, 37.4% and 43.8% of the population who were treated for the respective risk factors, with more than one-fourth of the controlled patients remaining at high risk. The ESC 2007 and ESC/ESH 2007 guidelines were the most popular (44.4% and 38.1% respectively), while the ESC/ESH tool was most frequently reported to be used by physicians for global CVD risk calculation (42%), followed by SCORE (36%), and Framingham (36%). The major barriers to the use of guidelines and risk calculation tools were the plethora of guidelines and time constraints (87.5% and 69.2% respectively). Control of key CVD risk factors appears to be suboptimal in primary prevention patients in Greece, with a remarkable proportion of controlled patients remaining at high risk. Although guidelines and global risk calculation tools are

  12. Gene expression profiles in auricle skin as a possible additional endpoint for determination of sensitizers: A multi-endpoint evaluation of the local lymph node assay.

    Science.gov (United States)

    Tsuchiyama, Hiromi; Maeda, Akihisa; Nakajima, Mayumi; Kitsukawa, Mika; Takahashi, Kei; Miyoshi, Tomoya; Mutsuga, Mayu; Asaoka, Yoshiji; Miyamoto, Yohei; Oshida, Keiyu

    2017-10-05

    The murine local lymph node assay (LLNA) is widely used to test chemicals to induce skin sensitization. Exposure of mouse auricle skin to a sensitizer results in proliferation of local lymph node T cells, which has been measured by in vivo incorporation of H 3 -methyl thymidine or 5-bromo-2'-deoxyuridine (BrdU). The stimulation index (SI), the ratio of the mean proliferation in each treated group to that in the concurrent vehicle control group, is frequently used as a regulatory-authorized endpoint for LLNA. However, some non-sensitizing irritants, such as sodium dodecyl sulfate (SDS) or methyl salicylate (MS), have been reported as false-positives by this endpoint. In search of a potential endpoint to enhance the specificity of existing endpoints, we evaluated 3 contact sensitizers; (hexyl cinnamic aldehyde [HCA], oxazolone [OXA], and 2,4-dinitrochlorobenzene [DNCB]), 1 respiratory sensitizer (toluene 2,4-diisocyanate [TDI]), and 2 non-sensitizing irritants (MS and SDS) by several endpoints in LLNA. Each test substance was applied to both ears of female CBA/Ca mice daily for 3 consecutive days. The ears and auricle lymph node cells were analyzed on day 5 for endpoints including the SI value, lymph node cell count, cytokine release from lymph node cells, and histopathological changes and gene expression profiles in auricle skin. The SI values indicated that all the test substances induced significant proliferation of lymph node cells. The lymph node cell counts showed no significant changes by the non-sensitizers assessed. The inflammatory findings of histopathology were similar among the auricle skins treated by sensitizers and irritants. Gene expression profiles of cytokines IFN-γ, IL-4, and IL-17 in auricle skin were similar to the cytokine release profiles in draining lymph node cells. In addition, the gene expression of the chemokine CXCL1 and/or CXCL2 showed that it has the potential to discriminate sensitizers and non-sensitizing irritants. Our results

  13. Correlation of Hip Fracture with Other Fracture Types: Toward a Rational Composite Hip Fracture Endpoint

    Science.gov (United States)

    Colón-Emeric, Cathleen; Pieper, Carl F.; Grubber, Janet; Van Scoyoc, Lynn; Schnell, Merritt L; Van Houtven, Courtney Harold; Pearson, Megan; Lafleur, Joanne; Lyles, Kenneth W.; Adler, Robert A.

    2016-01-01

    Purpose With ethical requirements to the enrollment of lower risk subjects, osteoporosis trials are underpowered to detect reduction in hip fractures. Different skeletal sites have different levels of fracture risk and response to treatment. We sought to identify fracture sites which cluster with hip fracture at higher than expected frequency; if these sites respond to treatment similarly, then a composite fracture endpoint could provide a better estimate of hip fracture reduction. Methods Cohort study using Veterans Affairs and Medicare administrative data. Male Veterans (n=5,036,536) aged 50-99 years receiving VA primary care between1999-2009 were included. Fractures were ascertained using ICD9 and CPT codes and classified by skeletal site. Pearson correlation coefficients, logistic regression and kappa statistics, were used to describe the correlation between each fracture type and hip fracture within individuals, without regards to the timing of the events. Results 595,579 (11.8%) men suffered 1 or more fractures and 179,597 (3.6%) suffered 2 or more fractures during the time under study. Of those with one or more fractures, rib was the most common site (29%), followed by spine (22%), hip (21%) and femur (20%). The fracture types most highly correlated with hip fracture were pelvic/acetabular (Pearson correlation coefficient 0.25, p<0.0001), femur (0.15, p<0.0001), and shoulder (0.11, p<0.0001). Conclusions Pelvic, acetabular, femur, and shoulder fractures cluster with hip fractures within individuals at greater than expected frequency. If we observe similar treatment risk reductions within that cluster, subsequent trials could consider use of a composite endpoint to better estimate hip fracture risk. PMID:26151123

  14. Operative and conservative management of primary gastric lymphoma: interim results of a German multicenter study

    International Nuclear Information System (INIS)

    Willich, Normann A.; Reinartz, Gabriele; Horst, Ekkehard J.; Delker, Georg; Reers, Berthold; Hiddemann, Wolfgang; Tiemann, Markus; Parwaresch, Reza; Grothaus-Pinke, Bernward; Kocik, Juergen; Koch, Peter

    2000-01-01

    Purpose/Objective: Biology and appropriate management of gastrointestinal (GI) lymphomas are matters of an ongoing controversial debate. To evaluate histological features, sites of involvement and management of primary GI-lymphomas, a prospective multicentric study was initiated in 10/1992. Aim of study was the further standardization of operative and conservative treatment modalities. Materials and Methods: Study started 10/1992 and was closed 11/1996. A total of 381 evaluable patients had been accrued then. Standardized diagnostic workup included endoscopic and radiological evaluation of the complete GI-tract as well as a central histological review. Diagnosis was established after Lewin, stage classification was made after Musshoff, and histological classification was made after Isaacson. Treatment decision concerning operative or conservative management was due to the initially acting physician. Patients with resection of low grade lymphoma received total abdominal irradiation 30 Gy + 10 Gy boost to incompletely resected areas. After resection of high grade lymphoma CHOP chemotherapy (4 cycles for stage IE, 6 cycles for higher stages) after McKelvy was followed by total abdominal irradiation 30 Gy for stage IE respectively involved field irradiation 30 Gy for higher stages with 10 Gy boost to incompletely resected areas. Primary conservative treatment consisted of six cycles COP chemotherapy after Bagley for low grade lymphomas stage >IE and total abdominal irradiation 30 Gy + 10 Gy boost to involved areas for all stages. Patients with high grade lymphomas received 4 x CHOP followed by total abdominal irradiation 30 Gy + 10 Gy boost to involved areas or 6 x CHOP plus involved field radiation therapy with 40 Gy. 257 patients are considered for analysis due to exclusion criteria of the study, 190 of them were suffered from gastric lymphoma. Their median observation time is 29 months, maximum observation time is 68 months. Results: Sites of involvement were

  15. Medium term results of total knee arthroplasty as a primary treatment for knee fractures

    Directory of Open Access Journals (Sweden)

    Ebied Ayman

    2018-01-01

    Conclusion: Knee arthroplasty achieves highly successful outcome when performed as a primary treatment for comminuted intra and periarticular knee fractures in elderly patients. Survival of implants and functional range of movement at midterm are excellent.

  16. Comparison of RNA-seq and microarray-based models for clinical endpoint prediction.

    Science.gov (United States)

    Zhang, Wenqian; Yu, Ying; Hertwig, Falk; Thierry-Mieg, Jean; Zhang, Wenwei; Thierry-Mieg, Danielle; Wang, Jian; Furlanello, Cesare; Devanarayan, Viswanath; Cheng, Jie; Deng, Youping; Hero, Barbara; Hong, Huixiao; Jia, Meiwen; Li, Li; Lin, Simon M; Nikolsky, Yuri; Oberthuer, André; Qing, Tao; Su, Zhenqiang; Volland, Ruth; Wang, Charles; Wang, May D; Ai, Junmei; Albanese, Davide; Asgharzadeh, Shahab; Avigad, Smadar; Bao, Wenjun; Bessarabova, Marina; Brilliant, Murray H; Brors, Benedikt; Chierici, Marco; Chu, Tzu-Ming; Zhang, Jibin; Grundy, Richard G; He, Min Max; Hebbring, Scott; Kaufman, Howard L; Lababidi, Samir; Lancashire, Lee J; Li, Yan; Lu, Xin X; Luo, Heng; Ma, Xiwen; Ning, Baitang; Noguera, Rosa; Peifer, Martin; Phan, John H; Roels, Frederik; Rosswog, Carolina; Shao, Susan; Shen, Jie; Theissen, Jessica; Tonini, Gian Paolo; Vandesompele, Jo; Wu, Po-Yen; Xiao, Wenzhong; Xu, Joshua; Xu, Weihong; Xuan, Jiekun; Yang, Yong; Ye, Zhan; Dong, Zirui; Zhang, Ke K; Yin, Ye; Zhao, Chen; Zheng, Yuanting; Wolfinger, Russell D; Shi, Tieliu; Malkas, Linda H; Berthold, Frank; Wang, Jun; Tong, Weida; Shi, Leming; Peng, Zhiyu; Fischer, Matthias

    2015-06-25

    Gene expression profiling is being widely applied in cancer research to identify biomarkers for clinical endpoint prediction. Since RNA-seq provides a powerful tool for transcriptome-based applications beyond the limitations of microarrays, we sought to systematically evaluate the performance of RNA-seq-based and microarray-based classifiers in this MAQC-III/SEQC study for clinical endpoint prediction using neuroblastoma as a model. We generate gene expression profiles from 498 primary neuroblastomas using both RNA-seq and 44 k microarrays. Characterization of the neuroblastoma transcriptome by RNA-seq reveals that more than 48,000 genes and 200,000 transcripts are being expressed in this malignancy. We also find that RNA-seq provides much more detailed information on specific transcript expression patterns in clinico-genetic neuroblastoma subgroups than microarrays. To systematically compare the power of RNA-seq and microarray-based models in predicting clinical endpoints, we divide the cohort randomly into training and validation sets and develop 360 predictive models on six clinical endpoints of varying predictability. Evaluation of factors potentially affecting model performances reveals that prediction accuracies are most strongly influenced by the nature of the clinical endpoint, whereas technological platforms (RNA-seq vs. microarrays), RNA-seq data analysis pipelines, and feature levels (gene vs. transcript vs. exon-junction level) do not significantly affect performances of the models. We demonstrate that RNA-seq outperforms microarrays in determining the transcriptomic characteristics of cancer, while RNA-seq and microarray-based models perform similarly in clinical endpoint prediction. Our findings may be valuable to guide future studies on the development of gene expression-based predictive models and their implementation in clinical practice.

  17. Hausdorff dimension of exponential parameter rays and their endpoints

    International Nuclear Information System (INIS)

    Bailesteanu, Mihai; Balan, Horia Vlad; Schleicher, Dierk

    2008-01-01

    We investigate the set I of parameters κ for which the singular value of z map e z + κ converges to ∞. The set I consists of uncountably many parameter rays, plus landing points of some of these rays (Förster et al 2008 Proc Am. Math. Soc. 136 at press (Preprint math.DS/0311427)). We show that the parameter rays have Hausdorff dimension 1, which implies (Qiu 1994 Acta Math. Sin. (N.S.) 10 362–8) that the ray endpoints in I alone have dimension 2. Analogous results were known for dynamical planes of exponential maps (Karpińska 1999 C. R. Acad. Sci. Paris Sér. I: Math. 328 1039–44; Schleicher and Zimmer 2003 J. Lond. Math. Soc. 67 380–400); our result shows that this also holds in parameter space

  18. A web-based endpoint adjudication system for interim analyses in clinical trials.

    Science.gov (United States)

    Nolen, Tracy L; Dimmick, Bill F; Ostrosky-Zeichner, Luis; Kendrick, Amy S; Sable, Carole; Ngai, Angela; Wallace, Dennis

    2009-02-01

    A data monitoring committee (DMC) is often employed to assess trial progress and review safety data and efficacy endpoints throughout a trail. Interim analyses performed for the DMC should use data that are as complete and verified as possible. Such analyses are complicated when data verification involves subjective study endpoints or requires clinical expertise to determine each subject's status with respect to the study endpoint. Therefore, procedures are needed to obtain adjudicated data for interim analyses in an efficient manner. In the past, methods for handling such data included using locally reported results as surrogate endpoints, adjusting analysis methods for unadjudicated data, or simply performing the adjudication as rapidly as possible. These methods all have inadequacies that make their sole usage suboptimal. For a study of prophylaxis for invasive candidiasis, adjudication of both study eligibility criteria and clinical endpoints prior to two interim analyses was required. Because the study was expected to enroll at a moderate rate and the sponsor required adjudicated endpoints to be used for interim analyses, an efficient process for adjudication was required. We created a web-based endpoint adjudication system (WebEAS) that allows for expedited review by the endpoint adjudication committee (EAC). This system automatically identifies when a subject's data are complete, creates a subject profile from the study data, and assigns EAC reviewers. The reviewers use the WebEAS to review the subject profile and submit their completed review form. The WebEAS then compares the reviews, assigns an additional review as a tiebreaker if needed, and stores the adjudicated data. The study for which this system was originally built was administratively closed after 10 months with only 38 subjects enrolled. The adjudication process was finalized and the WebEAS system activated prior to study closure. Some website accessibility issues presented initially. However

  19. Hippeastrum hybridum anthocyanins as indicators of endpoint in acid

    African Journals Online (AJOL)

    Anthocyanins from Hippeastrum hybridum (Amaryllis) were investigated as indicators of endpoint in acid- base titrations. Extraction of the anthocyanins was done using distilled water, methanol and methanol containing 0.5% acetic acid. The extracts were used in determination of endpoint in titrations between strong.

  20. Hippeastrum hybridum anthocyanins as indicators of endpoint in ...

    African Journals Online (AJOL)

    Anthocyanins from Hippeastrum hybridum (Amaryllis) were investigated as indicators of endpoint in acid- base titrations. Extraction of the anthocyanins was done using distilled water, methanol and methanol containing 0.5% acetic acid. The extracts were used in determination of endpoint in titrations between strong ...

  1. The impact of endpoint measures in rheumatoid arthritis clinical trials

    NARCIS (Netherlands)

    van der Heide, A.; Jacobs, J. W.; Dinant, H. J.; Bijlsma, J. W.

    1992-01-01

    In clinical trials on the effectiveness of disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA), it is common to apply a large number of endpoint measures. This practice has several disadvantages. To determine which endpoint measures are most valuable, reports of

  2. Imaging findings of primary breast sarcoma: Results of a first multicenter study

    Energy Technology Data Exchange (ETDEWEB)

    Wienbeck, Susanne, E-mail: susanne.wienbeck@med.uni-goettingen.de [University of Göttingen, Institute of Diagnostic and Interventional Radiology, Robert- Koch-Str. 40, 37075 Göttingen (Germany); Meyer, Hans Jonas [University Hospital Halle, Department of Radiology, Ernst-Grube-Str. 40, 06120 Halle (Germany); Herzog, Aimee [University of Jena, Institute of Diagnostic and Interventional Radiology, Erlanger Allee 101, 07747 Jena (Germany); Nemat, Sogand [University of Saarland, Clinic for Diagnostic and Interventional Radiology, Kirrberger Str. 100, 66424 Homburg (Germany); Teifke, Andrea [University of Mainz, Department of Diagnostic and Interventional Radiology, Langenbeckstr. 1, 55131 Mainz (Germany); Heindel, Walter [University of Münster, Institute of Clinical Radiology, Albert-Schweitzer-Str. 33, 48149 Münster (Germany); Schäfer, Fritz [University of Kiel, Institute of Radiology and Neuroradiology, Arnold-Heller-Str. 3, 24105 Kiel (Germany); Kinner, Sonja [University of Essen, Institute of Diagnostic and Interventional Radiology and Neuroradiology, Hufelandstr. 55, 45147 Essen (Germany); Müller-Schimpfle, Markus [Clinic Frankfurt Höchst, Department of Radiology, Gotenstr. 6, 65929 Frankfurt am Main (Germany); Surov, Alexey [University Hospital Halle, Department of Radiology, Ernst-Grube-Str. 40, 06120 Halle (Germany); University of Leipzig, Department of Diagnostic and Interventional Radiology, Liebigstr. 20, 04103 Leipzig (Germany)

    2017-03-15

    Purpose: To investigate imaging findings in patients with primary breast sarcoma (PBS). Materials and methods: A retrospective search in the databases of 10 radiological departments in Germany from 2000 to 2011 was performed. Only histologically proven cases of PBS were included into the study. Mammography was available in 31 patients (33 lesions), ultrasound images in 24 patients (24 lesions), and for 10 patients (14 lesions) magnetic resonance imaging (MRI) of the breast was performed. The breast findings were classified according to the American College of Radiology Breast Imaging Reporting and Data Systems (BI-RADS) 5th edition categories. Collected data were evaluated by means of descriptive statistics. Results: Forty-two female patients (mean age 62.0 years, range, 30–86 years) were included in the study. Clinically, all women had painless lumps. Irregular (53.3% [16/30]) or oval (30.0% [9/30]) mass with indistinct (73.3% [22/30]) or microlobulated (10% [3/30]) margins were common findings on mammograms. Ultrasound revealed typically an irregular (79.2% [19/24]), hypoechoic (62.5% [15/24]) mass, with indistinct margins (79.2% [19/24]), and posterior acoustic shadowing (79.2% [19/24]). MRI showed irregular masses (81.8% [9/11]) with irregular or spiculated margins, and a rapid initial signal increase with a delayed washout in kinetic analysis. Conclusion: Overall, PBS has no pathognomonic imaging features and can mimic those of invasive mammary carcinoma. Breast sarcoma should be taken into the differential diagnosis of breast findings described above.

  3. Primary Results from the Measurement of Nature Ice Nuclear Particles during 2017 Spring in Beijing, China

    Science.gov (United States)

    Che, Y.; Dang, J.; Fang, W.; Qian, Y.

    2017-12-01

    The ice nuclear particles (INPs) play a critical role in weather modification in mixed-phase clouds (MPCs) because ice can influence the supercooled liquid water content through the Wegener-Bergeron-Findeisen process. The fundamental desire to understand ice nucleation is the same as when such research began in earnest more than 60 years ago while the first cloud seeding activity began and enhanced from the last decade by climate change researches. The primary INPs sources, both from natural and anthropogenic, may be change a lot for decades. The purpose of this paper is to get the new background information of INPs and comparing with historical data. The INPs concentrations were observed twice a day(9:00 am and 14:00 pm) in Beijing from Mar. 20 to Apr. 19, 2017 using the 5 Litters Bigg's mixing cloud chamber. The method, time and sites of the observation are basically the same with the experiment at year 1963, 1995 and 1996. Compared with the previous observations, the observed activation temperature -10° is added, besides the -15°, -20°, -25°, -30°. The results show that the INPs concentrations at the different activation temperatures have good consistency trend as diurnal variation. This is consistent with the observations in 1963, 1995 and 1996. The INPs concentrations in this observation are higher than the result in 1963, but obviously lower than 1995 and 1996. It shows that natural changes and human activities in the past 20 years did not significantly increase the INPs concentration. During the observation period, there were weak precipitations in four days (Mar. 20, Mar. 22, Mar. 23, Mar.24), the INPs concentrations tended to decrease in the intermittent precipitation from Mar. 20 to Mar. 25. This shows that the precipitations have effect on the removal of ice nuclei. The visibility sensor was also synchronized observed in the work. There was clearly an inverse correlation between INPs concentration and visibility with the diurnal variation. The

  4. Biomarkers of intermediate endpoints in environmental and occupational health

    DEFF Research Database (Denmark)

    Knudsen, Lisbeth E; Hansen, Ase M

    2007-01-01

    The use of biomarkers in environmental and occupational health is increasing due to increasing demands on information about health risks from unfavourable exposures. Biomarkers provide information about individual loads. Biomarkers of intermediate endpoints benefit in comparison with biomarkers...... of exposure from the fact that they are closer to the adverse outcome in the pathway from exposure to health effects and may provide powerful information for intervention. Some biomarkers are specific, e.g., DNA and protein adducts, while others are unspecific like the cytogenetic biomarkers of chromosomal...... health effect from the result of the measurement has been performed for the cytogenetic biomarkers showing a predictive value of high levels of CA and increased risk of cancer. The use of CA in future studies is, however, limited by the laborious and sensitive procedure of the test and lack of trained...

  5. Comparing three novel endpoints for developmental osteotoxicity in the embryonic stem cell test

    International Nuclear Information System (INIS)

    Nieden, Nicole I. zur; Davis, Lesley A.; Rancourt, Derrick E.

    2010-01-01

    Birth defects belong to the most serious side effects of pharmaceutical compounds or environmental chemicals. In vivo, teratogens most often affect the normal development of bones, causing growth retardation, limb defects or craniofacial malformations. The embryonic stem cell test (EST) is one of the most promising models that allow the in vitro prediction of embryotoxicity, with one of its endpoints being bone tissue development. The present study was designed to describe three novel inexpensive endpoints to assess developmental osteotoxicity using the model compounds penicillin G (non-teratogenic), 5-fluorouracil (strong teratogen) and all-trans retinoic acid (bone teratogen). These three endpoints were: quantification of matrix incorporated calcium by (1) morphometric analysis and (2) measurement of calcium levels as well as (3) activity of alkaline phosphatase, an enzyme involved in matrix calcification. To evaluate our data, we have compared the concentration curves and resulting ID 50 s of the new endpoints with mRNA expression for osteocalcin. Osteocalcin is an exclusive marker found only in mineralized tissues, is regulated upon compound treatment and reliably predicts the potential of a chemical entity acting as a bone teratogen. By comparing the new endpoints to quantitative expression of osteocalcin, which we previously identified as suitable to detect developmental osteotoxicity, we were ultimately able to illustrate IMAGE analysis and Ca 2+ deposition assays as two reliable novel endpoints for the EST. This is of particular importance for routine industrial assessment of novel compounds as these two new endpoints may substitute previously used molecular read-out methods, which are often costly and time-consuming.

  6. Clinical evaluation of glass ionomer-silver cermet restorations in primary molars: one year results.

    Science.gov (United States)

    Hung, T W; Richardson, A S

    1990-03-01

    Using the half mouth technique, 33 silver amalgam (Dispersalloy) and 40 glass ionomer (Ketec silver) restorations were placed in the primary molars of children aged five to seven years. After one year, 73 restorations were evaluated. The amalgam restorations rated 90-100 per cent alpha for anatomic form and margins with no recurrent caries or fractures. The glass ionomer restorations rated 35 to 55 per cent alpha for anatomic form and margins with 40 per cent being replaced due to fracture of the material. Within the guidelines of this study, glass ionomer silver cermet was not a suitable material for the restoration of interproximal cavities in primary molars.

  7. Results obtained by quantifying skeleton scintiscanning for the evaluation of primary bone tumours

    International Nuclear Information System (INIS)

    Buell, U.; Keyl, W.; Meister, P.

    1985-01-01

    Since the region-of-interest technique can now more frequently be applied with nuclear-medical small computer systems available, this conference paper reports about the use of quantifying scintigraphy for evaluating the extent of uptake of Tc-99m-M.D.P. by the primary bone tumours. The quotients thus determined have been correlated with the histological findings for the most frequent bone tumours, for the purpose of assessing the dignity of a bone tumour by means of the quotients. Radiography, however, still is the most important imaging technique for the diagnosis of primary bone tumours. (orig./MG) [de

  8. Primary Self-Expandable Nitinol Stent Placement in Focal Lesions of Infrarenal Abdominal Aorta: Long Term Results

    International Nuclear Information System (INIS)

    Lastovickova, Jarmila; Peregrin, Jan H.

    2008-01-01

    Purpose. To evaluate the technical and clinical success, safety and long term results of percutaneous transluminal angioplasty/self-expandable nitinol stent placement of infrarenal abdominal aorta focal lesions. Materials and Methods. Eighteen patients underwent PTA of focal atherosclerotic occlusive disease of distal abdominal aorta. Two symptomatic occlusions and 16 stenoses in 10 male and 8 female patients (mean age 68.2 years) were treated with primary self-expandable nitinol stent placement. Results. Primary self-expandable nitinol stent placement was technically successful in all 18 procedures; clinical success was achieved in 100% of patients. No complications associated with the procedure occurred. During the 49.4 months of mean follow up (range 3-96, 4 months) all treated aortic segments remained patent. Conclusions. Endovascular treatment (primary self-expandable nitinol stent placement) of focal atherosclerotic lesions of distal abdominal aorta is a safe method with excellent primary technical and clinical success rates and favourable Long term results

  9. Long-term results after primary infrapopliteal angioplasty for limb ischemia

    International Nuclear Information System (INIS)

    Alfke, H.; Marburg Univ.; Vannucchi, A.; Froelich, J.J.; Klinikum Bad Hersfeld; El-Sheik, M.; Wagner, H.J.; Vivantes-Klinikum im Friedrichshain

    2007-01-01

    Purpose: To evaluate the technical success rate, procedure-related complications, and clinical long-term results for patients who underwent infrapopliteal angioplasty. Materials and Methods: We retrospectively evaluated all patients who underwent infrapopliteal angioplasty to treat critical chronic limb ischemia or severe claudication from 1/1997 to 12/1999. We excluded patients with acute (< 2 weeks) limb ischemia. Procedure-related data were prospectively documented in a database and analyzed with a focus on the technical success rate and procedure-related complications. In addition all clinical documents were analyzed, and a follow-up examination was performed or telephone interviews were conducted with patients, relatives and referring doctors for follow-up. The primary end points were the limb salvage rate and patient survival rate. The secondary end points included the complication rate, technical success rate, and walking distance. Results: 112 patients with a mean age of 72 years (41 women, 71 men) underwent crural angioplasty on 121 limbs. Four patients suffered from severe claudication (Rutherford category 3) and all others had critical chronic limb ischemia (category 4 to 6). The complication rate was 2.7 %. The technical success rate was 92 %. The ankle brachial index increased from 0.59 to 0.88. The mean walking distance increased significantly from 52 ± 66 to 284 ± 346 meters at the time of follow-up. The limb salvage rate was 83.6 % after one year and 81.1 % after three years. The mean survival rate according to Kaplan-Meier was 79.4 %, 69.2 %, and 54.2 % at 1, 2, and 3 years, respectively. Patients with at least one patent run-off vessel after angioplasty had a significantly better limb salvage rate. Diabetes was not a risk factor for limb salvage. Conclusion: Infrapopliteal angioplasty shows a high technical success rate with an acceptable complication rate. The clinical long-term success seems favorable if a least one open run-off vessel was

  10. Long-term results after primary infrapopliteal angioplasty for limb ischemia; Langzeitergebnisse nach Ballonangioplastie kruraler Arterien

    Energy Technology Data Exchange (ETDEWEB)

    Alfke, H. [Klinikum Luedenscheid (Germany). Klinik fuer Diagnostische und Interventionelle Radiologie; Marburg Univ. (Germany). Klinik fuer Strahlendiagnostik; Vannucchi, A. [Marburg Univ. (Germany). Klinik fuer Strahlendiagnostik; Froelich, J.J. [Marburg Univ. (Germany). Klinik fuer Strahlendiagnostik; Klinikum Bad Hersfeld (Germany). Klinik fuer Radiologie und Nuklearmedizin; El-Sheik, M.; Wagner, H.J. [Marburg Univ. (Germany). Klinik fuer Strahlendiagnostik; Vivantes-Klinikum im Friedrichshain (Germany). Inst. fuer Radiologie und Interventionelle Therapie

    2007-08-15

    Purpose: To evaluate the technical success rate, procedure-related complications, and clinical long-term results for patients who underwent infrapopliteal angioplasty. Materials and Methods: We retrospectively evaluated all patients who underwent infrapopliteal angioplasty to treat critical chronic limb ischemia or severe claudication from 1/1997 to 12/1999. We excluded patients with acute (< 2 weeks) limb ischemia. Procedure-related data were prospectively documented in a database and analyzed with a focus on the technical success rate and procedure-related complications. In addition all clinical documents were analyzed, and a follow-up examination was performed or telephone interviews were conducted with patients, relatives and referring doctors for follow-up. The primary end points were the limb salvage rate and patient survival rate. The secondary end points included the complication rate, technical success rate, and walking distance. Results: 112 patients with a mean age of 72 years (41 women, 71 men) underwent crural angioplasty on 121 limbs. Four patients suffered from severe claudication (Rutherford category 3) and all others had critical chronic limb ischemia (category 4 to 6). The complication rate was 2.7 %. The technical success rate was 92 %. The ankle brachial index increased from 0.59 to 0.88. The mean walking distance increased significantly from 52 {+-} 66 to 284 {+-} 346 meters at the time of follow-up. The limb salvage rate was 83.6 % after one year and 81.1 % after three years. The mean survival rate according to Kaplan-Meier was 79.4 %, 69.2 %, and 54.2 % at 1, 2, and 3 years, respectively. Patients with at least one patent run-off vessel after angioplasty had a significantly better limb salvage rate. Diabetes was not a risk factor for limb salvage. Conclusion: Infrapopliteal angioplasty shows a high technical success rate with an acceptable complication rate. The clinical long-term success seems favorable if a least one open run-off vessel was

  11. Application of process analytical technology for monitoring freeze-drying of an amorphous protein formulation: use of complementary tools for real-time product temperature measurements and endpoint detection.

    Science.gov (United States)

    Schneid, Stefan C; Johnson, Robert E; Lewis, Lavinia M; Stärtzel, Peter; Gieseler, Henning

    2015-05-01

    Process analytical technology (PAT) and quality by design have gained importance in all areas of pharmaceutical development and manufacturing. One important method for monitoring of critical product attributes and process optimization in laboratory scale freeze-drying is manometric temperature measurement (MTM). A drawback of this innovative technology is that problems are encountered when processing high-concentrated amorphous materials, particularly protein formulations. In this study, a model solution of bovine serum albumin and sucrose was lyophilized at both conservative and aggressive primary drying conditions. Different temperature sensors were employed to monitor product temperatures. The residual moisture content at primary drying endpoints as indicated by temperature sensors and batch PAT methods was quantified from extracted sample vials. The data from temperature probes were then used to recalculate critical product parameters, and the results were compared with MTM data. The drying endpoints indicated by the temperature sensors were not suitable for endpoint indication, in contrast to the batch methods endpoints. The accuracy of MTM Pice data was found to be influenced by water reabsorption. Recalculation of Rp and Pice values based on data from temperature sensors and weighed vials was possible. Overall, extensive information about critical product parameters could be obtained using data from complementary PAT tools. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

  12. Results of a multidisciplinary program for patients with fibromyalgia implemented in the primary care

    NARCIS (Netherlands)

    van Wilgen, C.P.; Bloten, H.; Oeseburg, B.

    2007-01-01

    Purpose. Fibromyalgia is a syndrome of unknown origin with a high prevalence. Multimodal approaches seem to be the treatment of choice in fibromyalgia. A multidisciplinary program was developed and implemented for patients with fibromyalgia in the primary care setting. The program included education

  13. Results of postoperative reirradiation for recurrent or second primary head and neck carcinoma

    NARCIS (Netherlands)

    Kasperts, N; Slotman, BJ; Leemans, CR; de Bree, R; Doornaert, P; Langendijk, JA

    2006-01-01

    BACKGROUND. In this prospective study, the effects of a second course of postoperative radiation therapy on locoregional control, survival, toxicity, and quality of life were investigated in patients who underwent resection of a second primary or locoregional recurrent head and neck tumor in a

  14. Results of primary versus recurrent surgery to treat stress urinary incontinence in women

    NARCIS (Netherlands)

    van der Doelen, Maarten J; Withagen, Mariëlla I J; Vierhout, Mark E; Heesakkers, John P F A

    INTRODUCTION AND HYPOTHESIS: We compared cure rates and complication rates in patients who had undergone primary or recurrent (secondary) surgery for stress urinary incontinence (SUI). METHODS: A retrospective cohort study that included patients who underwent surgery to treat SUI in a tertiary

  15. Results of primary versus recurrent surgery to treat stress urinary incontinence in women

    NARCIS (Netherlands)

    Doelen, M.J. van der; Withagen, M.I.J.; Vierhout, M.E.; Heesakkers, J.P.F.A.

    2015-01-01

    INTRODUCTION AND HYPOTHESIS: We compared cure rates and complication rates in patients who had undergone primary or recurrent (secondary) surgery for stress urinary incontinence (SUI). METHODS: A retrospective cohort study that included patients who underwent surgery to treat SUI in a tertiary

  16. False Negative Fine Needle Aspiration Biopsy Results in Primary Thyroid Lymphoma

    Energy Technology Data Exchange (ETDEWEB)

    Kim, In Joong; Kim, Eun Kyung; Koh, Myoung Ju; Kwak, Jin Young; Moon, Hee Jung [Yonsei University College of Medicine, Seoul (Korea, Republic of)

    2012-06-15

    Ultrasonography-guided fine needle aspiration biopsy (US-FNA) is one of the methods used to diagnose thyroid lymphoma, but it has a relatively high false-negative rate. The authors report a case of a primary thyroid lymphoma associated with underlying lymphocytic thyroiditis that was initially misdiagnosed as lymphocytic thyroiditis based on US-FNA findings

  17. Primary Disseminated Multifocal Ewing Sarcoma: Results of the Euro-EWING 99 Trial

    NARCIS (Netherlands)

    Ladenstein, Ruth; Pötschger, Ulrike; Le Deley, Marie Cécile; Whelan, Jeremy; Paulussen, Michael; Oberlin, Odile; van den Berg, Henk; Dirksen, Uta; Hjorth, Lars; Michon, Jean; Lewis, Ian; Craft, Alan; Jürgens, Heribert

    2010-01-01

    Purpose To improve the poor prognosis of patients with primary disseminated multifocal Ewing sarcomas (PDMES) with a dose-intense treatment concept. Patients and Methods From 1999 to 2005, 281 patients with PDMES were enrolled onto the Euro-EWING 99 R3 study. Median age was 16.2 years (range, 0.4 to

  18. Awareness of hypertension guidelines in primary care: results of a regionwide survey in Italy.

    Science.gov (United States)

    Cuspidi, C; Michev, I; Meani, S; Severgnini, B; Sala, C; Salerno, M; Valerio, C; Bertazzoli, G; Leonetti, G; Magrini, F; Zanchetti, A

    2003-08-01

    Unsatisfactory blood pressure (BP) control so often described in treated hypertensive populations is also explained by insufficient physicians' awareness of experts' guidelines. We assessed awareness of current recommendations about hypertension management in a general practice setting, using the World Health Organization/International Society of Hypertension (WHO/ISH) 1999 guidelines as reference. In a regionwide survey, a total of 5133 physicians (three-quarters of all active general practitioners in Lombardy, a region of north-western Italy) were contacted by letter and received a multiple choice 10-item questionnaire. Data on physicians' demographic characteristics, information on hypertension prevalence and their perception of BP control among their patients were also requested in an additional form. The number of answers in agreement with WHO/ISH guidelines was used as an awareness measure. This was considered adequate if correct answers to six out of 10 questions, including an appropriate definition of hypertension, were provided. Of the 1256 returned questionnaires (a 24.5% response rate), 1162 were suitable for analysis. The mean score of correct answers was 5.3 points and only 20.1% of the study population correctly answered at least six of the questions (including that on the definition of hypertension in the elderly). Guidelines awareness was negatively related to increase in physicians' age and duration of clinical practice and by the male gender. Finally, the physicians reported a high rate of achieved BP control, and those who were considered to have achieved highest rates (>75%) of control in their patients had a lower rate of adequate knowledge than those who reported less-successful therapeutic results (18 vs 25%, P<0.01), suggesting that they ignored or disregarded the goal BP recommended by the guidelines. This large regional survey shows that a sufficient degree of guidelines awareness is present in a minority of primary-care physicians in the

  19. Endpoint in plasma etch process using new modified w-multivariate charts and windowed regression

    Science.gov (United States)

    Zakour, Sihem Ben; Taleb, Hassen

    2017-09-01

    Endpoint detection is very important undertaking on the side of getting a good understanding and figuring out if a plasma etching process is done in the right way, especially if the etched area is very small (0.1%). It truly is a crucial part of supplying repeatable effects in every single wafer. When the film being etched has been completely cleared, the endpoint is reached. To ensure the desired device performance on the produced integrated circuit, the high optical emission spectroscopy (OES) sensor is employed. The huge number of gathered wavelengths (profiles) is then analyzed and pre-processed using a new proposed simple algorithm named Spectra peak selection (SPS) to select the important wavelengths, then we employ wavelet analysis (WA) to enhance the performance of detection by suppressing noise and redundant information. The selected and treated OES wavelengths are then used in modified multivariate control charts (MEWMA and Hotelling) for three statistics (mean, SD and CV) and windowed polynomial regression for mean. The employ of three aforementioned statistics is motivated by controlling mean shift, variance shift and their ratio (CV) if both mean and SD are not stable. The control charts show their performance in detecting endpoint especially W-mean Hotelling chart and the worst result is given by CV statistic. As the best detection of endpoint is given by the W-Hotelling mean statistic, this statistic will be used to construct a windowed wavelet Hotelling polynomial regression. This latter can only identify the window containing endpoint phenomenon.

  20. Bioremediation of hydrocarbon-contaminated soils: are treatability and ecotoxicity endpoints related?

    International Nuclear Information System (INIS)

    Visser, S.

    1999-01-01

    To determine if there is a relationship between biotreatability and ecotoxicity endpoints in a wide range of hydrocarbon-contaminated soils, including medium and heavy crude oil-contaminated flare pit wastes and lubrication oil contaminated soil, research was conducted. Each test material was analyzed for pH, water repellency, electrical conductivity, available N and P, total extractable hydrocarbons, oil and grease, and toxicity to seedling emergence, root elongation in barley, lettuce and canola, earthworm survival and luminescent bacteria (Microtox), prior to, and following three months of bioremediation in the laboratory. By monitoring soil respiration, progress of the bioremediation process and determination of a treatment endpoint were assessed. The time required to attain a treatment endpoint under laboratory conditions can range from 30 days to 100 days depending on the concentration of hydrocarbons and degree of weathering. Most flare pits are biotreatable, averaging a loss of 25-30% of hydrocarbons during bioremediation. Once a treatment endpoint is achieved, residual hydrocarbons contents almost always exceeds Alberta Tier I criteria for mineral oil and grease. As a result of bioremediation treatments, hydrophobicity is often reduced from severe to low. Many flare pit materials are still moderately to extremely toxic after reaching a treatment endpoint. (Abstract only)

  1. Results of a study on solar collectors on primary school buildings; Resultaten onderzoek zonnepanelen op basisscholen

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-11-15

    A survey has been carried out among a large number of primary schools in the Netherlands with the aim to map experiences and constraints with regard to the use of solar collectors on the school buildings [Dutch] Om bestaande (succes)ervaringen en belemmeringen met betrekking tot plaatsing en gebruik van zonnepanelen in kaart te brengen, is een enquete uitgezet onder een groot aantal basisscholen in Nederland.

  2. Ecosystem services as assessment endpoints for ecological risk assessment.

    Science.gov (United States)

    Munns, Wayne R; Rea, Anne W; Suter, Glenn W; Martin, Lawrence; Blake-Hedges, Lynne; Crk, Tanja; Davis, Christine; Ferreira, Gina; Jordan, Steve; Mahoney, Michele; Barron, Mace G

    2016-07-01

    Ecosystem services are defined as the outputs of ecological processes that contribute to human welfare or have the potential to do so in the future. Those outputs include food and drinking water, clean air and water, and pollinated crops. The need to protect the services provided by natural systems has been recognized previously, but ecosystem services have not been formally incorporated into ecological risk assessment practice in a general way in the United States. Endpoints used conventionally in ecological risk assessment, derived directly from the state of the ecosystem (e.g., biophysical structure and processes), and endpoints based on ecosystem services serve different purposes. Conventional endpoints are ecologically important and susceptible entities and attributes that are protected under US laws and regulations. Ecosystem service endpoints are a conceptual and analytical step beyond conventional endpoints and are intended to complement conventional endpoints by linking and extending endpoints to goods and services with more obvious benefit to humans. Conventional endpoints can be related to ecosystem services even when the latter are not considered explicitly during problem formulation. To advance the use of ecosystem service endpoints in ecological risk assessment, the US Environmental Protection Agency's Risk Assessment Forum has added generic endpoints based on ecosystem services (ES-GEAE) to the original 2003 set of generic ecological assessment endpoints (GEAEs). Like conventional GEAEs, ES-GEAEs are defined by an entity and an attribute. Also like conventional GEAEs, ES-GEAEs are broadly described and will need to be made specific when applied to individual assessments. Adoption of ecosystem services as a type of assessment endpoint is intended to improve the value of risk assessment to environmental decision making, linking ecological risk to human well-being, and providing an improved means of communicating those risks. Integr Environ Assess Manag

  3. HANFORD DOUBLE SHELL TANK (DST) THERMAL & SEISMIC PROJECT BUCKLING EVALUATION METHODS & RESULTS FOR THE PRIMARY TANKS

    Energy Technology Data Exchange (ETDEWEB)

    MACKEY TC; JOHNSON KI; DEIBLER JE; PILLI SP; RINKER MW; KARRI NK

    2007-02-14

    This report documents a detailed buckling evaluation of the primary tanks in the Hanford double-shell waste tanks (DSTs), which is part of a comprehensive structural review for the Double-Shell Tank Integrity Project. This work also provides information on tank integrity that specifically responds to concerns raised by the Office of Environment, Safety, and Health (ES&H) Oversight (EH-22) during a review of work performed on the double-shell tank farms and the operation of the aging waste facility (AWF) primary tank ventilation system. The current buckling review focuses on the following tasks: (1) Evaluate the potential for progressive I-bolt failure and the appropriateness of the safety factors that were used for evaluating local and global buckling. The analysis will specifically answer the following questions: (a) Can the EH-22 scenario develop if the vacuum is limited to -6.6-inch water gage (w.g.) by a relief valve? (b) What is the appropriate factor of safety required to protect against buckling if the EH-22 scenario can develop? (c) What is the appropriate factor of safety required to protect against buckling if the EH-22 scenario cannot develop? (2) Develop influence functions to estimate the axial stresses in the primary tanks for all reasonable combinations of tank loads, based on detailed finite element analysis. The analysis must account for the variation in design details and operating conditions between the different DSTs. The analysis must also address the imperfection sensitivity of the primary tank to buckling. (3) Perform a detailed buckling analysis to determine the maximum allowable differential pressure for each of the DST primary tanks at the current specified limits on waste temperature, height, and specific gravity. Based on the I-bolt loads analysis and the small deformations that are predicted at the unfactored limits on vacuum and axial loads, it is very unlikely that the EH-22 scenario (i.e., progressive I-bolt failure leading to global

  4. Preliminary results of transarterial rhenium-188 HDD lipiodol in the treatment of inoperable primary hepatocellular carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Sundram, Felix [Nuclear Medicine Department (The PET Centre), Singapore General Hospital, Block 2 Basement 1, Outram Road, 169608 (Singapore); Chau, Tran Chi Minh [Nuclear Medicine Department, Cho Ray Hospital, Ho Chi Minh City (Viet Nam); Onkhuudai, Peljee [Nuclear Medicine Department, First Central University Hospital, Ulaanbatax (Mongolia); Bernal, Patricia [Nuclear Medicine Department, Fundacion Santa Fe, Bogota (Colombia); Padhy, Ajit Kumar [Division of Human Health, International Atomic Energy Agency, Vienna (Austria)

    2004-02-01

    treated in the dose escalation phase of the study, when the activities administered started at 1.8 GBq (50 mCi) and rose to 7.7 GBq (206 mCi). In the efficacy phase of the study a further 54 patients were treated. Both groups of patients are included in this paper. The treatment activity of {sup 188}Re-lipiodol administered transarterially ranged from 1.8 to 9.8 GBq (50-265 mCi), with a mean activity of 4.6 GBq (124 mCi). Survival at 3 months was 90%, and at 6 months, 60%; 19% survived for 1 year. Mean survival after treatment in the total treated group of 70 patients was 9.5 months, with a range of 1-18 months. The results of the study show that {sup 188}Re-lipiodol is a safe and cost-effective method to treat primary HCC via the transarterial route. (orig.)

  5. Scintigraphic evaluation of primary congenital hypothyroidism: results of the Greek screening program

    Energy Technology Data Exchange (ETDEWEB)

    Panoutsopoulos, G.; Ilias, I.; Batsakis, C.; Christakopoulou, I. [Dept. of Nuclear Medicine, ' ' Sotiria' ' Hospital, Athens (Greece); Mengreli, C. [Inst. of Child Health, Athens (Greece)

    2001-04-01

    The Greek screening program for primary congenital hypothyroidism was initiated in 1979. By early 2000, thyrotropin measurements had been performed in 1,976,719 newborns, using dried blood spots obtained by heel prick. Among these children, 584 were diagnosed with congenital hypothyroidism (incidence: 1/3,384 births) and were given L-thyroxine (L-T{sub 4}) replacement therapy. In order to further evaluate and classify the children as having either an aplastic (AT) or an ectopic thyroid gland (ET) or as showing thyroidal dyshormonogenesis (DN, with a nomotopic gland), scintigraphic studies were performed at the age of 2-3 years. In 413 children of this age group (including 24 subsequently diagnosed as having had transient hypothyroidism, in whom L-T{sub 4} therapy was not resumed), thyroid hormones were measured and scintigraphic studies were done after withdrawal of L-T{sub 4} replacement treatment for 3 weeks. Given the long duration of the study, we used various scintigraphic modalities. In 96 children (group A), scintigraphy was performed using technetium-99m pertechnetate ({sup 99m}TcO{sub 4}{sup -}; 18.5 MBq given i.v.) and a rectilinear scanner. Seventy-three children (group B) were studied with {sup 99m}TcO{sub 4}{sup -} (18.5 MBq given i.v.) and a gamma camera equipped with a pinhole collimator. In these groups, atropine was administered 30 min prior to the study (0.02 mg/kg i.v. or i.m.) in order to reduce the secretion of saliva from the salivary glands. Finally, in the remaining 220 children (group C) iodine-123 sodium iodide ({sup 123}I-Na) (0.74-1.85 MBq i.v.) and the same gamma camera were used. Between-group comparisons of scintigraphic findings were done with the chi square test. In 191 children from group C, thyroglobulin (Tg) was measured and in 49 children ultrasound (US) was performed (categorising the gland as AT or ET/DN). Comparison of these modalities was done with the kappa statistic. In group A, 61.5% of children had AT, 26.0% had ET and

  6. Preliminary results of transarterial rhenium-188 HDD lipiodol in the treatment of inoperable primary hepatocellular carcinoma

    International Nuclear Information System (INIS)

    Sundram, Felix; Chau, Tran Chi Minh; Onkhuudai, Peljee; Bernal, Patricia; Padhy, Ajit Kumar

    2004-01-01

    of the study, when the activities administered started at 1.8 GBq (50 mCi) and rose to 7.7 GBq (206 mCi). In the efficacy phase of the study a further 54 patients were treated. Both groups of patients are included in this paper. The treatment activity of 188 Re-lipiodol administered transarterially ranged from 1.8 to 9.8 GBq (50-265 mCi), with a mean activity of 4.6 GBq (124 mCi). Survival at 3 months was 90%, and at 6 months, 60%; 19% survived for 1 year. Mean survival after treatment in the total treated group of 70 patients was 9.5 months, with a range of 1-18 months. The results of the study show that 188 Re-lipiodol is a safe and cost-effective method to treat primary HCC via the transarterial route. (orig.)

  7. Defining Primary Care Shortage Areas: Do GIS-based Measures Yield Different Results?

    Science.gov (United States)

    Daly, Michael R; Mellor, Jennifer M; Millones, Marco

    2018-02-12

    To examine whether geographic information systems (GIS)-based physician-to-population ratios (PPRs) yield determinations of geographic primary care shortage areas that differ from those based on bounded-area PPRs like those used in the Health Professional Shortage Area (HPSA) designation process. We used geocoded data on primary care physician (PCP) locations and census block population counts from 1 US state to construct 2 shortage area indicators. The first is a bounded-area shortage indicator defined without GIS methods; the second is a GIS-based measure that measures the populations' spatial proximity to PCP locations. We examined agreement and disagreement between bounded shortage areas and GIS-based shortage areas. Bounded shortage area indicators and GIS-based shortage area indicators agree for the census blocks where the vast majority of our study populations reside. Specifically, 95% and 98% of the populations in our full and urban samples, respectively, reside in census blocks where the 2 indicators agree. Although agreement is generally high in rural areas (ie, 87% of the rural population reside in census blocks where the 2 indicators agree), agreement is significantly lower compared to urban areas. One source of disagreement suggests that bounded-area measures may "overlook" some shortages in rural areas; however, other aspects of the HPSA designation process likely mitigate this concern. Another source of disagreement arises from the border-crossing problem, and it is more prevalent. The GIS-based PPRs we employed would yield shortage area determinations that are similar to those based on bounded-area PPRs defined for Primary Care Service Areas. Disagreement rates were lower than previous studies have found. © 2018 National Rural Health Association.

  8. PTB’s Primary Clock CS1: First Results After Its Reconstruction

    Science.gov (United States)

    1996-12-01

    intense atomic beam and the frequency instability up (7 = 1 s) is predicted to be 4.10- la , based on the 62.5 Hz linewidth and the signal-to-noise...will be put into final operation as a clock again. REFERENCES [I] K. Dorenwendt 1986, "Realization and dissemination of the second, " Metrologia ...T. HeindorfT, R. Schroder, and B. Fischer 1996, "The P T B primary clod CS3: type B evaluation of its standard uncertainty," Metrologia , 33, 249

  9. Portuguese School Libraries Evaluation Model: An Analysis of Primary Schools' Results for the "Reading and Literacy" Domain

    Science.gov (United States)

    Martins, Jorge Tiago; Martins, Rosa Maria

    2012-01-01

    This paper reports the implementation results of the Portuguese School Libraries Evaluation Model, more specifically the results of primary schools self-evaluation of their libraries' reading promotion and information literacy development activities. School libraries that rated their performance as either "Excellent" or "Poor"…

  10. Radiometric titration of officinal radiopharmaceuticals using radioactive kryptonates as end-point indicators. I

    International Nuclear Information System (INIS)

    Toelgyessy, J.; Dillinger, P.; Harangozo, M.; Jombik, J.

    1980-01-01

    A method for the determination of salicylic, acetylsalicylic and benzoic acids in officinal pharmaceutical based on radiometric titration with 0.1 mol.l -1 NaOH was developed. The end-point was detected with the aid of radioactive glass kryptonate. After the end-point, the excess titrant attacks the glass surface layers and this results in releasing 85 Kr, and consequently, in decreasing the radioactivity of the kryptonate employed. The radioactive kryptonate used as an indicator was prepared by the bombardment of glass with accelerated 85 Kr ions. The developed method is simple, accurate and correct. (author)

  11. Gastroenterological endpoints in drug trials for cystic fibrosis

    NARCIS (Netherlands)

    Bodewes, Frank A. J. A.; Verkade, Henkjan J.; Wilschanski, Micheal

    2016-01-01

    The phenotype of cystic fibrosis includes a wide variety of clinical and biochemical gastrointestinal presentations. These gastrointestinal characteristics of the disease have come under renewed interest as potential outcome measures and clinical endpoints for therapeutic trials in cystic fibrosis.

  12. Endpoint behavior of high-energy scattering cross sections

    International Nuclear Information System (INIS)

    Chay, Junegone; Kim, Chul

    2010-01-01

    In high-energy processes near the endpoint, there emerge new contributions associated with spectator interactions. Away from the endpoint region, these new contributions are suppressed compared to the leading contribution, but the leading contribution becomes suppressed as we approach the endpoint and the new contributions become comparable. We present how the new contributions scale as we reach the endpoint and show that they are comparable to the suppressed leading contributions in deep inelastic scattering by employing a power-counting analysis. The hadronic tensor in deep inelastic scattering is shown to factorize including the spectator interactions, and it can be expressed in terms of the light cone distribution amplitudes of initial hadrons. We also consider the contribution of the spectator contributions in Drell-Yan processes. Here the spectator interactions are suppressed compared to double parton annihilation according to the power counting.

  13. A systematic comparison of recurrent event models for application to composite endpoints.

    Science.gov (United States)

    Ozga, Ann-Kathrin; Kieser, Meinhard; Rauch, Geraldine

    2018-01-04

    Many clinical trials focus on the comparison of the treatment effect between two or more groups concerning a rarely occurring event. In this situation, showing a relevant effect with an acceptable power requires the observation of a large number of patients over a long period of time. For feasibility issues, it is therefore often considered to include several event types of interest, non-fatal or fatal, and to combine them within a composite endpoint. Commonly, a composite endpoint is analyzed with standard survival analysis techniques by assessing the time to the first occurring event. This approach neglects that an individual may experience more than one event which leads to a loss of information. As an alternative, composite endpoints could be analyzed by models for recurrent events. There exists a number of such models, e.g. regression models based on count data or Cox-based models such as the approaches of Andersen and Gill, Prentice, Williams and Peterson or, Wei, Lin and Weissfeld. Although some of the methods were already compared within the literature there exists no systematic investigation for the special requirements regarding composite endpoints. Within this work a simulation-based comparison of recurrent event models applied to composite endpoints is provided for different realistic clinical trial scenarios. We demonstrate that the Andersen-Gill model and the Prentice- Williams-Petersen models show similar results under various data scenarios whereas the Wei-Lin-Weissfeld model delivers effect estimators which can considerably deviate under commonly met data scenarios. Based on the conducted simulation study, this paper helps to understand the pros and cons of the investigated methods in the context of composite endpoints and provides therefore recommendations for an adequate statistical analysis strategy and a meaningful interpretation of results.

  14. [Indicator condition guided human immunodeficiency virus requesting in primary health care: results of a collaboration].

    Science.gov (United States)

    Cayuelas-Redondo, Laia; Menacho-Pascual, Ignacio; Noguera-Sánchez, Pablo; Goicoa-Gago, Carmen; Pollio-Peña, Gernónimo; Blanco-Delgado, Rebeca; Barba-Ávila, Olga; Sequeira-Aymar, Ethel; Muns, Mercè; Clusa, Thais; García, Felipe; León, Agathe

    2015-12-01

    The search of HIV infected patients guided by indicator conditions (IC) is a strategy used to increase the early detection of HIV. The objective is to analyze whether a collaboration to raise awareness of the importance of early detection of HIV in 3 primary care centers influenced the proportion of HIV serology requested. Multicenter retrospective study was conducted comparing the baseline and a post-collaboration period. The collaboration consisted of training sessions and participation in the HIDES study (years 2009-2010). Patients between 18 and 64 years old with newly diagnosed herpes zoster, seborrheic eczema, mononucleosis syndrome, and leucopenia/thrombocytopenia in 3 primary care centers in 2008 (baseline period) and 2012 (post-collaboration period). The sociodemographic variables, HIV risk conditions, requests for HIV serology, and outcomes were evaluated. A total of 1,219 ICs were included (558 in 2008 and 661 in 2012). In 2008 the number of HIV tests in patients with an IC was 3.9%, and rose to 11.8% in 2012 (Pde Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  15. Primary Cutting Balloon Angioplasty for Treatment of Venous Stenoses in Native Hemodialysis Fistulas: Long-Term Results from Three Centers

    International Nuclear Information System (INIS)

    Bhat, Rajesh; McBride, Kieran; Chakraverty, Sam; Vikram, Raghunandan; Severn, Alison

    2007-01-01

    Aim. To evaluate the technical success and patency rates following primary cutting balloon angioplasty for venous stenoses in native dialysis fistulas. Methods. Forty-one patients (26 men, 15 women; age range 26-82 years, average age 59 years) underwent 50 (repeat procedures in 9 patients) primary cutting balloon (PCB) angioplasty procedures in three institutions by three primary operators. The indication was primary stenosis in 21 patients, recurrent lesions in 15, and immature fistulas in 5. A PCB was used alone in 17 cases, but was followed by a larger standard balloon in 33 cases. Follow-up included ultrasound, flow analysis and urea reduction ratio, and ranged from 2 to 30 months (mean 14 months). Results. The technical success rate was 98%. All procedures were relatively painless. Two PCBs burst and 4 leaked, but without causing any morbidity. Nineteen fistulas were still working at last follow-up. Primary patency rates at 6, 12, and 24 months using Kaplan-Meier analysis were 88%, 73%, and 34%, respectively, and the primary assisted patencies were 90%, 75%, and 50%, respectively. Conclusion. PCB angioplasty has high technical success and low complication rates. The long-term patency rates are favorable for PCB angioplasty and compare favorably with other series

  16. Laboratory and field testing results of the LMT/GTM primary surface actuators

    Science.gov (United States)

    Smith, David R.; Souccar, Kamal; Montalvo, Gabriela; Arteaga Magaña, César; Hernández Rebollar, José Luis; Olmos Tapia, Arak; Gallieni, Daniele; Lazzarini, Paolo; Fumi, Pierluigi; Anaclerio, Enzo

    2016-07-01

    With the final installation of the two outermost rings of the primary surface of the Large Millimeter Telescope/ Gran Telescopio Milimétrico (LMT/GTM), the project is also upgrading the primary surface actuators. There are commercial actuators that can approach the required operational accuracy and stroke, but the combination of the size and load requirements ultimately required a customized design. The new actuators fit within the volume constraints imposed by the tighter interior angles in the outer rings and are designed to support the operational and survival loading conditions even for the largest surface segments. Laboratory testing confirmed that the actuators should meet the precision, repeatability, load, and lifetime requirements. However, the LMT/GTM is at a particularly difficult site for electromechanical systems. The high altitude has the usual effect of reducing cooling effectiveness for the drives and motors, and the ambient temperature hovers near freezing. Since there is a significant amount of precipitation during some times of the year, there are frequent freeze/thaw cycles. The constant formation and either sublimation or melting of ice, along with the associated high humidity, has been a challenge for the environmental protection of many devices at the LMT/GTM. Because there are a total of 720 primary surface actuators in the system, it is particularly important that the actuators, their local drive control boxes, and their cable connections be able to meet its specifications even under the site conditions. To confirm the suitability of the actuators, the LMT/GTM procured an initial set of sixteen actuators for testing at the site. After laboratory testing, the actuators were installed into the outer two rings of the telescope and cycled during the early winter months of the 2015-16 scientific observing season. Because of the continuing installation activities in these two rings, they are not illuminated by the receivers, so field testing

  17. Pregnancy Options Counseling and Abortion Referrals Among US Primary Care Physicians: Results From a National Survey.

    Science.gov (United States)

    Holt, Kelsey; Janiak, Elizabeth; McCormick, Marie C; Lieberman, Ellice; Dehlendorf, Christine; Kajeepeta, Sandhya; Caglia, Jacquelyn M; Langer, Ana

    2017-07-01

    Primary care physicians (PCPs) can play a critical role in addressing unintended pregnancy through high-quality options counseling and referrals. We surveyed a nationally representative sample of 3,000 PCPs in general, family, and internal medicine on practices and opinions related to options counseling for unintended pregnancy. We assessed predictors of physician practices using multivariable logistic regression weighted for sampling design and differential non-response. Response rate was 29%. Seventy-one percent believed residency training in options counseling should be required, and 69% believed PCPs have an obligation to provide abortion referrals even in the presence of a personal objection to abortion. However, only 26% reported routine options counseling when caring for women with unintended pregnancy compared to 60% who routinely discuss prenatal care. Among physicians who see women seeking abortion, 62% routinely provide referrals, while 14% routinely attempt to dissuade women. Family physicians were more likely to provide routine options counseling when seeing patients with unintended pregnancy than internal medicine physicians (32% vs 21%, P=0.002). In multivariable analyses, factors associated with higher odds of routine abortion referrals were more years in practice (OR=1.03 for each additional year, 95% CI: 1.00-1.05), identifying as a woman vs a man (OR=2.11, 95% CI: 1.31-3.40), practicing in a hospital vs private primary care/multispecialty setting (OR=3.17, 95% CI: 1.10-9.15), and no religious affiliation of practice vs religious affiliation (OR for Catholic affiliation=0.27, 95% CI: 0.11-0.66; OR for other religious affiliation=0.36, 95% CI: 0.15-0.83). Personal Christian religious affiliation among physicians who regularly attend religious services vs no religious affiliation was associated with lower odds of counseling (OR=0.48, 95% CI: 0.26-0.90) and referrals (OR=0.31, 95% CI: 0.15-0.62), and higher odds of abortion dissuasion (OR=4.03, 95

  18. Preliminary results of transarterial Rhenium-188 HDD Lipiodol in treatment of inoperable primary hepatocellular carcinoma

    International Nuclear Information System (INIS)

    Sundram, Felix

    2004-01-01

    after therapy, until recovery from all toxicity. The clinical parameters evaluated included toxicity, response as determined by contrast-enhanced CT, palliation of symptoms, overall survival, performance status (Karnofsky) and hepatic function (Child's classification). Liver function tests, serum alphafetoprotein (AFP) levels and complete blood counts were done at each follow-up visit. In the majority of patients, from the 'scout' dose studies, the radiation absorbed dose to normal liver was the limiting factor to the treatment dose, or in a few patients by dose to lung. Radiation dose to bone marrow was negligible and was thus not a factor for the MTA calculations. Side effects were minimal and usually presented as loss of appetite, right hypochondrial discomfort and low-grade fever, even at high levels of administered radioactivity. The symptoms resolved with simple supportive therapy within 3 days of onset. Liver function tests at 24 and 72 hours showed no significant changes and complete blood counts at one week, four weeks and 12 weeks showed no changes (no bone-marrow suppression). Sixteen patients were treated in the dose escalation phase of the study when the activities administered started at 1.8 GBq (50 mCi) and continued to 7.7 GBq (206 mCi). In the efficacy phase of the study, further 54 patients were treated. The treatment activity of Re-188 HDD lipiodol administered trans-arterially ranged from 1.8 to 9.8 GBq (50 to 265 mCi), with a mean activity of 4.6 GBq (124 mCi). Survival at 3 months was 90%, and at six months was 60%,, while 19% survived for 1 year. Mean survival after treatment in the total treated group of 70 patients was 9.5 months, with a range of 1-18 months. The results of this multi-center study show that rhenium-188 lipiodol is a safe and cost-effective method to treat primary HCC via the trans-arterial route. In terms of efficacy, it is potentially a new therapeutic approach for further evaluation by treatment of larger numbers of patients

  19. Diagnosing cancer in primary care: results from the National Cancer Diagnosis Audit.

    Science.gov (United States)

    Swann, Ruth; McPhail, Sean; Witt, Jana; Shand, Brian; Abel, Gary A; Hiom, Sara; Rashbass, Jem; Lyratzopoulos, Georgios; Rubin, Greg

    2018-01-01

    Continual improvements in diagnostic processes are needed to minimise the proportion of patients with cancer who experience diagnostic delays. Clinical audit is a means of achieving this. To characterise key aspects of the diagnostic process for cancer and to generate baseline measures for future re-audit. Clinical audit of cancer diagnosis in general practices in England. Information on patient and tumour characteristics held in the English National Cancer Registry was supplemented by information from GPs in participating practices. Data items included diagnostic timepoints, patient characteristics, and clinical management. Data were collected on 17 042 patients with a new diagnosis of cancer during 2014 from 439 practices. Participating practices were similar to non-participating ones, particularly regarding population age, urban/rural location, and practice-based patient experience measures. The median diagnostic interval for all patients was 40 days (interquartile range [IQR] 15-86 days). Most patients were referred promptly (median primary care interval 5 days [IQR 0-27 days]). Where GPs deemed diagnostic delays to have occurred (22% of cases), patient, clinician, or system factors were responsible in 26%, 28%, and 34% of instances, respectively. Safety netting was recorded for 44% of patients. At least one primary care-led investigation was carried out for 45% of patients. Most patients (76%) had at least one existing comorbid condition; 21% had three or more. The findings identify avenues for quality improvement activity and provide a baseline for future audit of the impact of 2015 National Institute for Health and Care Excellence guidance on management and referral of suspected cancer. © British Journal of General Practice 2018.

  20. Energetic endpoints provide early indicators of life history effects in a freshwater gastropod exposed to the fungicide, pyraclostrobin

    International Nuclear Information System (INIS)

    Fidder, Bridgette N.; Reátegui-Zirena, Evelyn G.; Olson, Adric D.; Salice, Christopher J.

    2016-01-01

    Organismal energetics provide important insights into the effects of environmental toxicants. We aimed to determine the effects of pyraclostrobin on Lymnaea stagnalis by examining energy allocation patterns and life history traits. Juvenile snails exposed to pyraclostrobin decreased feeding rate and increased apparent avoidance behaviors at environmentally relevant concentrations. In adults, we found that sublethal concentrations of pyraclostrobin did not affect reproductive output, however, there were significant effects on developmental endpoints with longer time to hatch and decreased hatching success in pyraclostrobin-exposed egg masses. Further, there were apparent differences in developmental effects depending on whether mothers were also exposed to pyraclostrobin suggesting this chemical can exert intergenerational effects. Pyraclostrobin also affected protein and carbohydrate content of eggs in mothers that were exposed to pyraclostrobin. Significant effects on macronutrient content of eggs occurred at lower concentrations than effects on gross endpoints such as hatching success and time to hatch suggesting potential value for these endpoints as early indicators of ecologically relevant stress. These results provide important insight into the effects of a common fungicide on important endpoints for organismal energetics and life history. - Highlights: • We exposed a freshwater snail to relevant concentrations of pyraclostrobin. • We monitored energetic and life history endpoints. • Pyraclostrobin affected feeding, hatching success and egg macronutrient content. • Energetic-based endpoints may provide valuable insight to toxic effects. - The fungicide pyraclostrobin at environmentally relevant concentrations effects a range of life history and energetic endpoints in the freshwater snail, Lymnaea stagnalis.

  1. Traditional and new composite endpoints in heart failure clinical trials : facilitating comprehensive efficacy assessments and improving trial efficiency

    NARCIS (Netherlands)

    Anker, Stefan D. t; Schroeder, Stefan; Atar, Dan; Bax, Jeroen J.; Ceconi, Claudio; Cowie, Martin R.; AdamCrisp,; Dominjon, Fabienne; Ford, Ian; Ghofrani, Hossein-Ardeschir; Gropper, Savion; Hindricks, Gerhard; Hlatky, Mark A.; Holcomb, Richard; Honarpour, Narimon; Jukema, J. Wouter; Kim, Albert M.; Kunz, Michael; Lefkowitz, Martin; Le Floch, Chantal; Landmesser, Ulf; McDonagh, Theresa A.; McMurray, John J.; Merkely, Bela; Packer, Milton; Prasad, Krishna; Revkin, James; Rosano, Giuseppe M. C.; Somaratne, Ransi; Stough, Wendy Gattis; Voors, Adriaan A.; Ruschitzka, Frank

    Composite endpoints are commonly used as the primary measure of efficacy in heart failure clinical trials to assess the overall treatment effect and to increase the efficiency of trials. Clinical trials still must enrol large numbers of patients to accrue a sufficient number of outcome events and

  2. Data summary of all endpoints measured

    Data.gov (United States)

    U.S. Environmental Protection Agency — qPCR results for Vitellogenin. This dataset is associated with the following publication: Armstrong, B., J. Lazorchak , K. Jensen , H. Haring , M.E. Smith, R. Flick...

  3. Primary and Secondary Organic Marine Aerosol and Oceanic Biological Activity: Recent Results and New Perspectives for Future Studies

    Directory of Open Access Journals (Sweden)

    Matteo Rinaldi

    2010-01-01

    Full Text Available One of the most important natural aerosol systems at the global level is marine aerosol that comprises both organic and inorganic components of primary and secondary origin. The present paper reviews some new results on primary and secondary organic marine aerosol, achieved during the EU project MAP (Marine Aerosol Production, comparing them with those reported in the recent literature. Marine aerosol samples collected at the coastal site of Mace Head, Ireland, show a chemical composition trend that is influenced by the oceanic biological activity cycle, in agreement with other observations. Laboratory experiments show that sea-spray aerosol from biologically active sea water can be highly enriched in organics, and the authors highlight the need for further studies on the atmospheric fate of such primary organics. With regard to the secondary fraction of organic aerosol, the average chemical composition and molecular tracer (methanesulfonic-acid, amines distribution could be successfully characterized by adopting a multitechnique analytical approach.

  4. Effect of intravenous TRO40303 as an adjunct to primary percutaneous coronary intervention for acute ST-elevation myocardial infarction: MITOCARE study results.

    Science.gov (United States)

    Atar, Dan; Arheden, Håkan; Berdeaux, Alain; Bonnet, Jean-Louis; Carlsson, Marcus; Clemmensen, Peter; Cuvier, Valérie; Danchin, Nicolas; Dubois-Randé, Jean-Luc; Engblom, Henrik; Erlinge, David; Firat, Hüseyin; Halvorsen, Sigrun; Hansen, Henrik Steen; Hauke, Wilfried; Heiberg, Einar; Koul, Sasha; Larsen, Alf-Inge; Le Corvoisier, Philippe; Nordrehaug, Jan Erik; Paganelli, Franck; Pruss, Rebecca M; Rousseau, Hélène; Schaller, Sophie; Sonou, Giles; Tuseth, Vegard; Veys, Julien; Vicaut, Eric; Jensen, Svend Eggert

    2015-01-07

    The MITOCARE study evaluated the efficacy and safety of TRO40303 for the reduction of reperfusion injury in patients undergoing revascularization for ST-elevation myocardial infarction (STEMI). Patients presenting with STEMI within 6 h of the onset of pain randomly received TRO40303 (n = 83) or placebo (n = 80) via i.v. bolus injection prior to balloon inflation during primary percutaneous coronary intervention in a double-blind manner. The primary endpoint was infarct size expressed as area under the curve (AUC) for creatine kinase (CK) and for troponin I (TnI) over 3 days. Secondary endpoints included measures of infarct size using cardiac magnetic resonance (CMR) and safety outcomes. The median pain-to-balloon time was 180 min for both groups, and the median (mean) door-to-balloon time was 60 (38) min for all sites. Infarct size, as measured by CK and TnI AUCs at 3 days, was not significantly different between treatment groups. There were no significant differences in the CMR-assessed myocardial salvage index (1-infarct size/myocardium at risk) (mean 52 vs. 58% with placebo, P = 0.1000), mean CMR-assessed infarct size (21.9 g vs. 20.0 g, or 17 vs. 15% of LV-mass) or left ventricular ejection fraction (LVEF) (46 vs. 48%), or in the mean 30-day echocardiographic LVEF (51.5 vs. 52.2%) between TRO40303 and placebo. A greater number of adjudicated safety events occurred in the TRO40303 group for unexplained reasons. This study in STEMI patients treated with contemporary mechanical revascularization principles did not show any effect of TRO40303 in limiting reperfusion injury of the ischaemic myocardium. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

  5. Primary Maternity Units in rural and remote Australia: Results of a national survey.

    Science.gov (United States)

    Kruske, Sue; Kildea, Sue; Jenkinson, Bec; Pilcher, Jennifer; Robin, Sarah; Rolfe, Margaret; Kornelsen, Jude; Barclay, Lesley

    2016-09-01

    Primary Maternity Units (PMUs) offer less expensive and potentially more sustainable maternity care, with comparable or better perinatal outcomes for normal pregnancy and birth than higherlevel units. However, little is known about how these maternity services operate in rural and remote Australia, in regards to location, models of care, service structure, support mechanisms or sustainability. This study aimed to confirm and describe how they operate. a descriptive, cross-sectional study was undertaken, utilising a 35-item survey to explore current provision of maternity care in rural and remote PMUs across Australia. Data were subjected to simple descriptive statistics and thematic analysis for free text answers. Only 17 PMUs were identified in rural and remote areas of Australia. All 17 completed the survey. the PMUs were, on average, 56km or 49minutes from their referral service and provided care to an average of 59 birthing women per year. Periodic closures or downgrading of services was common. Low-risk eligibility criteria were universally used, but with some variability. Medically-led care was the most widely available model of care. In most PMUs midwives worked shift work involving both nursing and midwifery duties, with minimal uptake of recent midwifery workforce innovations. Perceived enablers of, and threats to, sustainability were reported. a small number of PMUs operate in rural Australia, and none in remote areas. Continuing overreliance on local medical support, and under-utilisation of the midwifery workforce constrain the restoration of maternity services to rural and remote Australia. Copyright © 2016 Elsevier Ltd. All rights reserved.

  6. Primary Immunodeficiency Diseases in Aguascalientes, Mexico: Results from an Educational Program.

    Science.gov (United States)

    Alvarez-Cardona, Aristoteles; Espinosa-Padilla, Sara Elva; Reyes, Saul Oswaldo Lugo; Ventura-Juarez, Javier; Lopez-Valdez, Jaime Asael; Martínez-Medina, Lucila; Santillan-Artolozaga, Alberto; Cajero-Avelar, Adriana; De Luna-Sosa, Alma R; Torres-Bernal, Luis F; Espinosa-Rosales, Francisco J

    2016-04-01

    Primary immunodeficiencies (PIDs) are a heterogeneous group of disorders characterized mainly by recurrent infections. Late diagnosis remains as one of the main issues to solve. We aimed to increase PID diagnosis in Aguascalientes, a 1.3 million inhabitants state in the center of Mexico, and to describe the clinical features of such patients. We developed an educational program for health personnel and general public; patients with possible PID were referred to a State University clinical center from December 2011 to December 2012. The patients were evaluated at the clinic and their definitive diagnosis pursued through laboratory, molecular and genetic assays. We describe the findings of those patients and analyze the impact of the program in terms of number of referrals. After 41 talks and 12 media appearances 151 patients were referred for evaluation. Fifteen (9.9%) were diagnosed with PID: five (33%) had antibody deficiencies, seven (47%) Well-defined syndromes, two (13%) Severe combined Immunodeficiency (SCID) and one case (7%) of an innate immune deficiency. All of the 15 PID patients had been referred by physicians, as opposed to the public. We estimated a "number needed to teach" of 75 physicians to get one PID patient referral. Educational programs are a fundamental part of the global efforts to increase PID diagnosis and care. To be successful, such programs should include public relations, reach for first-contact physicians, and aim to develop an efficient referral network with molecular diagnostic capability. Enhancing medical knowledge on PID is a successful strategy to improve early diagnosis and treatment.

  7. Second primary cancer following Hodgkin's disease: Updated results of an Italian multicentric study

    International Nuclear Information System (INIS)

    Cimino, G.; Papa, G.; Tura, S.; Mazza, P.; Rossi Ferrini, P.L.; Bosi, A.; Amadori, S.; Lo Coco, F.; D'Arcangelo, E.; Giannarelli, D.

    1991-01-01

    The risk of second primary cancer (SPC) was evaluated in 947 patients treated for Hodgkin's disease (HD) during the period January 1969 to December 1979. The median follow-up of this series was 10.5 years (range, 9 to 19). Treatment categories included radiotherapy (RT) alone (115 patients, 12%), chemotherapy (CHT) alone (161 patients, 17%), combined RT plus CHT (381 patients, 40%), and salvage treatment for resistant or relapsing HD (290 patients, 30.6%). Fifty-six SPCs were observed, occurring between 1 and 17 years from initial treatment. Among these, secondary acute nonlymphoid leukemia (s-ANLL) was the most frequent SPC (23 cases). Secondary non-Hodgkin's lymphoma (s-NHL) occurred in 5 patients, whereas a secondary solid tumor (s-ST) was observed in 28 patients. The calculated actuarial risk (+/- SE) of developing SPC was 5.0% (+/- 0.9%) and 23.1% (+/- 5.8%) at 10 and 19 years, respectively. Concerning treatment modalities and s-ANLL risk, no cases were observed in the radiotherapy group, whereas CHT plus RT and salvage groups showed the highest actuarial risk. This was, in fact, at 10 and 19 years, 3.1% (+/- 0.9%) and 8.1% (+/- 4.0%) in the former group, and 1.8% (+/- 1.0%) and 16% (+/- 9.0%) in the latter. A statistically significant difference was observed when the CHT plus RT group was compared with CHT and RT groups (P = .04). Concerning the relationships with chemotherapeutic regimens, 12 s-ANLL cases occurred in the mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) plus RT group, and only one case in the group receiving doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) plus RT. A statistically significant difference of s-ANLL actuarial risk was found comparing patients receiving MOPP plus RT to all other treatment groups (P = .04)

  8. Does bisphenol A induce superfeminization in Marisa cornuarietis? Part I: intra- and inter-laboratory variability in test endpoints.

    Science.gov (United States)

    Forbes, Valery E; Selck, Henriette; Palmqvist, Annemette; Aufderheide, John; Warbritton, Ryan; Pounds, Nadine; Thompson, Roy; van der Hoeven, Nelly; Caspers, Norbert

    2007-03-01

    It has been claimed that bisphenol A (BPA) induces superfeminization in the freshwater gastropod, Marisa cornuarietis. To explore the reproducibility of prior work, here we present results from a three-laboratory study, the objectives of which were to determine the mean and variability in test endpoints (i.e., adult fecundity, egg hatchability, and juvenile growth) under baseline conditions and to identify the sources of variability. A major source of variability for all of the measured endpoints was due to differences within and among individuals. With few exceptions, variability among laboratories and among replicate tanks within laboratories contributed little to the observed variability in endpoints. The results highlight the importance of obtaining basic knowledge of husbandry requirements and baseline information on life-history traits of potential test species prior to designing toxicity test protocols. Understanding of the levels and sources of endpoint variability is essential so that statistically robust and ecologically relevant tests of chemicals can be conducted.

  9. Surgical Results of Trabeculectomy and Ahmed Valve Implantation Following a Previous Failed Trabeculectomy in Primary Congenital Glaucoma Patients

    OpenAIRE

    Lee, Naeun; Ma, Kyoung Tak; Bae, Hyoung Won; Hong, Samin; Seong, Gong Je; Hong, Young Jae; Kim, Chan Yun

    2015-01-01

    Purpose To compare the surgical results of trabeculectomy and Ahmed glaucoma valve implantation after a previous failed trabeculectomy. Methods A retrospective comparative case series review was performed on 31 eye surgeries in 20 patients with primary congenital glaucoma who underwent trabeculectomy or Ahmed glaucoma valve implantation after a previous failed trabeculectomy with mitomycin C. Results The preoperative mean intraocular pressure was 25.5 mmHg in the trabeculectomy group and 26.9...

  10. Confirmatory versus explorative endpoint analysis: Decision-making on the basis of evidence available from market authorization and early benefit assessment for oncology drugs.

    Science.gov (United States)

    Niehaus, Ines; Dintsios, Charalabos-Markos

    2018-03-26

    The early benefit assessment of pharmaceuticals in Germany and their preceding market authorization pursue different objectives. This is reflected by the inclusion of varying confirmatory endpoints within the evaluation of oncology drugs in early benefit assessment versus market authorization, with both relying on the same evidence. Data from assessments up to July 2015 are used to estimate the impact of explorative in comparison to confirmatory endpoints on market authorization and early benefit assessment by contrasting the benefit-risk ratio of EMA and the benefit-harm balance of the HTA jurisdiction. Agreement between market authorization and early benefit assessment is examined by Cohen's kappa (k). 21 of 41 assessments were considered in the analysis. Market authorization is more confirmatory than early benefit assessment because it includes a higher proportion of primary endpoints. The latter implies a primary endpoint to be relevant for the benefit-harm balance in only 67% of cases (0.078). Explorative mortality endpoints reached the highest agreement regarding the mutual consideration for the risk-benefit ratio and the benefit-harm balance (0.000). For explorative morbidity endpoints (-0.600), quality of life (-0.600) and side effects (-0.949) no agreement is ascertainable. To warrant a broader confirmatory basis for decisions supported by HTA, closer inter-institutional cooperation of approval authorities and HTA jurisdictions by means of reliable joint advice for manufacturers regarding endpoint definition would be favorable. Copyright © 2018 Elsevier B.V. All rights reserved.

  11. Three-Dimensional Radiation Therapy to the Primary Tumor With Concurrent Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer: Results of a Multicenter Phase 2 Study From PPRA-RTOG, China

    Energy Technology Data Exchange (ETDEWEB)

    Su, ShengFa [Department of Thoracic Oncology, Affiliated Hospital of Guizhou Medical University, and Guizhou Cancer Hospital, Guiyang (China); Teaching and Research Section of Oncology, Guizhou Medical University, Guiyang (China); Li, Tao [Department of Radiation Oncology, Sichuan Cancer Hospital, Chengdu (China); Lu, Bing, E-mail: lbgymaaaa@163.com [Department of Thoracic Oncology, Affiliated Hospital of Guizhou Medical University, and Guizhou Cancer Hospital, Guiyang (China); Teaching and Research Section of Oncology, Guizhou Medical University, Guiyang (China); Wang, XiaoHu, E-mail: xhwanggansu@163.com [Department of Radiation Oncology, Gansu Cancer Hospital, Lanzhou (China); Li, JianCheng [Department of Radiation Oncology, Fujian Provincial Cancer Hospital, Fuzhou (China); Chen, Ming [Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou (China); Lu, You [Department of Thoracic Oncology and State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu (China); Bai, YuJu [Department of Oncology, Affiliated Hospital of Zunyi Medical College, Zunyi (China); Hu, YinXiang; Ouyang, WeiWei; Ma, Zhu; Li, QingSong; Li, HuiQin; Wang, Yu [Department of Thoracic Oncology, Affiliated Hospital of Guizhou Medical University, and Guizhou Cancer Hospital, Guiyang (China); Teaching and Research Section of Oncology, Guizhou Medical University, Guiyang (China)

    2015-11-15

    Purpose: The aim of this prospective multi-institutional phase 2 study was to investigate disease control, survival outcomes, and toxicity after thoracic three-dimensional radiation therapy (3D-RT) with concurrent chemotherapy for newly diagnosed stage IV non-small cell lung cancer (NSCLC). Methods and Materials: Eligible patients were 18 to 80 years of age, had a Karnofsky performance status (KPS) score ≥70%, and newly diagnosed stage IV NSCLC with limited metastatic disease (defined as involving ≤3 organs). Patients received platinum-doublet chemotherapy with concurrent irradiation to the primary tumor. Primary endpoints were overall survival (OS) and acute toxicity. Results: From May 2008 to May 2012, 198 eligible patients were enrolled from 7 cancer centers. Most patients died with distant metastasis; only 10% died with isolated primary recurrence. Median OS time was 13.0 months (95% confidence interval [CI]: 11.7-14.3); OS rates were 53.5% at 1 year, 15.8% at 2 years, and 9.2% at 3 years. Median progression-free survival (PFS) time was 9.0 months (95% CI: 7.7-10.3); corresponding PFS rates were 30.8%, 8.2%, and 6.1%. The 1-year, 2-year, and 3-year local (primary tumor) control rates were 78.8%, 57.7%, and 55.4%. Multivariate analysis showed that delivery of ≥63 Gy to the primary tumor (P=.014), having a primary tumor volume <134 cm{sup 3} (P=.008), and having a stable or higher KPS score after treatment (P=.01) were independent predictors of better OS. The most common severe (grades 3-4) acute toxicities were hematologic: leukopenia (37.9%), thrombocytopenia (10.1%), and anemia (6.9%). No patients experienced grade 4 or 5 radiation-related toxicity; 2.5% had acute grade 3 pneumonitis, and 6.6% had acute grade 3 radiation esophagitis. Conclusions: Thoracic 3D-RT to the primary tumor with concurrent chemotherapy led to satisfactory survival outcomes with acceptable toxicity. Radiation dose, primary tumor volume, and PFS after treatment all

  12. Preliminary results of lab-scale investigations of products of incomplete combustion during incineration of primary and mixed digested sludge.

    Science.gov (United States)

    Braguglia, C M; Bagnuolo, G; Gianico, A; Mininni, G; Pastore, C; Mascolo, G

    2016-03-01

    Separation between primary and secondary sludge treatment could be a valuable solution for sludge management. According to this approach, secondary sludge can be conveniently used in agriculture while primary sludge could be easily dried and incinerated. It follows that some concern may arise from incinerating primary sludge with respect to the current practice to incinerate mixed digested sludge. Incineration of primary and mixed digested municipal sludge was investigated with a lab-scale equipment in terms of emissions of products of incomplete combustion (PICs) during incineration failure modes. PICs can be grouped in three sub-categories, namely aliphatic hydrocarbons (alkanes and alkenes), compounds with a single aromatic ring, and polycyclic aromatic hydrocarbons (PAHs). After-burning temperature was the most important parameter to be controlled in order to minimize emissions of alkanes and alkenes. As for mono-aromatic compounds, benzene and toluene are the most thermally resistant compounds, and in some cases, an after-burning temperature of 1100 °C was not enough to get the complete destruction of benzene leading to a residual emission of 18 mg/kgsludge. PAHs showed an opposite trend with respect to aliphatic and mono-aromatic hydrocarbons being the thermal failure mode the main responsible of PIC emissions. A proper oxygen concentration is more important than elevated temperature thus reflecting the high thermal stability of PAHs. Overall, obtained results, even though obtained under flameless conditions that are different from those of the industrial plants, demonstrated that separation of primary and secondary sludge does not pose any drawbacks or concern regarding primary sludge being disposed of by incineration even though it is more contaminated than mixed digested sludge in terms of organic pollutants.

  13. Biochemical endpoints of glucocorticoid hormone action

    Energy Technology Data Exchange (ETDEWEB)

    Young, D.A.; Nicholson, M.L.; Guyette, W.A.; Giddings, S.J.; Mendelsohn, S.L.; Nordeen, S.K.; Lyons, R.T.

    1978-01-01

    Both the rapidly evolving metabolic effects of glucocorticoids and the more slowly developing lethal actions appear to be initiated via the synthesis of new mRNAs and proteins. The chronic suppression of cell growth may be the consequence of suppression of overall rates of protein synthesis (and probably RNA and DNA synthesis as well) that in turn may represent the cellular response to the small changes in ratios of adenine nucleotides that result from the suppression of oxidative ATP production. The inhibition of glucose transport may also play a role here to prevent a compensatory increase in glycolytic ATP production. Some other hormone actions, the decrease in the ability of cells to concentrate AIB and the increase in nuclear fragility are unrelated to, and evolve separately from, the hormonal inhibitions on energy production. Cell killing is not the result of suppression of protein synthesis, nor of hormone-induced increases in calcium uptake. While the mechanisms are unknown, the increase in nuclear fragility appears to be the earliest measure of their operation. In tumor cells resistance to lethal actions of glucocorticoids may emerge via the selection of cells with hardier membranes, that are better able to withstand the intracellular destructive events set in motion by high levels of glucocorticoids.

  14. Consumer opinions about print and on-line pay contents according to primary research results

    Directory of Open Access Journals (Sweden)

    Katalin Jäckel

    2014-07-01

    Full Text Available In this paper we present the sub results of a primer research project process. Themain objective of survey was to explore the effectof the digitalization onto themedia consumption habits, with a strange look ontothe print and the on-line paycontents. During the research we applied qualitative and quantitative methods. Weanalysed the most important changes of the media consumption preferences withthe help of expert interviews and consumers surveystaking the influencing role ofthe international trends onto consideration. Basedon the results of the researchcan be characterised the main target groups of on-line pay contents and the printmediums.

  15. In vitro systems: standardization of endpoints

    International Nuclear Information System (INIS)

    Dewey, W.C.

    1979-01-01

    Principles are discussed for utilizing cell culture systems to assay for interactions between drugs and radiation. Emphasis is based on the necessity of using synchronous cultures to determine whether the interaction is independent, additive, or synergistic, and to determine the effect of drugs on recovery from sublethal x-ray damage (SLD). Furthermore, in studies of drug effects on SLD, adequate controls must be included to distinguish between effects associated with the interaction of 2 x-ray doses and the effects associated with interaction of a second x-ray dose with prior drug exposure. Finally, different methods of expressing drug exposure are reviewed, and associated problems related to predicting in vivo effects from in vitro results are mentioned

  16. Large bowel cancer: Indications for and results of radiation as primary or adjuvant treatment

    International Nuclear Information System (INIS)

    Gunderson, L.L.; Rich, T.A.

    1987-01-01

    The intent of this chapter is to develop a logical approach to the use of radiation with large bowel cancer. Incidence and areas of failure after operation alone are outlined by site and stage with implications for adjuvant therapy. Results of series utilizing radiation are presented, and the potential for the future is discussed

  17. Results of primary and postoperative radiotherapy of malignant tumours of the larynx and posterior pharynx

    International Nuclear Information System (INIS)

    Poppele, G.

    1980-01-01

    In a study on the epidemiology of laryngeal and pharyngeal tumours, a coincidence was found between established alcohol abuse and tumours of the two organs. The results of surgery followed by gammatron radiotherapy (laryngeal tumours) or betatron therapy (pharyngeal tumours) are prescuted and discussed. (APR) [de

  18. UAS Integration in the NAS Project: Part Task 6 V & V Simulation: Primary Results

    Science.gov (United States)

    Rorie, Conrad; Fern, Lisa; Shively, Jay; Santiago, Confesor

    2016-01-01

    This is a presentation of the preliminary results on final V and V (Verification and Validation) activity of [RTCA (Radio Technical Commission for Aeronautics)] SC (Special Committee)-228 DAA (Detect and Avoid) HMI (Human-Machine Interface) requirements for display alerting and guidance.

  19. Bystander effect: Biological endpoints and microarray analysis

    Energy Technology Data Exchange (ETDEWEB)

    Chaudhry, M. Ahmad [Department of Medical Laboratory and Radiation Sciences, College of Nursing and Health Sciences, University of Vermont, 302 Rowell Building, Burlington, VT 05405 (United States) and DNA Microarray Facility, University of Vermont, Burlington, VT 05405 (United States)]. E-mail: mchaudhr@uvm.edu

    2006-05-11

    In cell populations exposed to ionizing radiation, the biological effects occur in a much larger proportion of cells than are estimated to be traversed by radiation. It has been suggested that irradiated cells are capable of providing signals to the neighboring unirradiated cells resulting in damage to these cells. This phenomenon is termed the bystander effect. The bystander effect induces persistent, long-term, transmissible changes that result in delayed death and neoplastic transformation. Because the bystander effect is relevant to carcinogenesis, it could have significant implications for risk estimation for radiation exposure. The nature of the bystander effect signal and how it impacts the unirradiated cells remains to be elucidated. Examination of the changes in gene expression could provide clues to understanding the bystander effect and could define the signaling pathways involved in sustaining damage to these cells. The microarray technology serves as a tool to gain insight into the molecular pathways leading to bystander effect. Using medium from irradiated normal human diploid lung fibroblasts as a model system we examined gene expression alterations in bystander cells. The microarray data revealed that the radiation-induced gene expression profile in irradiated cells is different from unirradiated bystander cells suggesting that the pathways leading to biological effects in the bystander cells are different from the directly irradiated cells. The genes known to be responsive to ionizing radiation were observed in irradiated cells. Several genes were upregulated in cells receiving media from irradiated cells. Surprisingly no genes were found to be downregulated in these cells. A number of genes belonging to extracellular signaling, growth factors and several receptors were identified in bystander cells. Interestingly 15 genes involved in the cell communication processes were found to be upregulated. The induction of receptors and the cell

  20. Bystander effect: Biological endpoints and microarray analysis

    International Nuclear Information System (INIS)

    Chaudhry, M. Ahmad

    2006-01-01

    In cell populations exposed to ionizing radiation, the biological effects occur in a much larger proportion of cells than are estimated to be traversed by radiation. It has been suggested that irradiated cells are capable of providing signals to the neighboring unirradiated cells resulting in damage to these cells. This phenomenon is termed the bystander effect. The bystander effect induces persistent, long-term, transmissible changes that result in delayed death and neoplastic transformation. Because the bystander effect is relevant to carcinogenesis, it could have significant implications for risk estimation for radiation exposure. The nature of the bystander effect signal and how it impacts the unirradiated cells remains to be elucidated. Examination of the changes in gene expression could provide clues to understanding the bystander effect and could define the signaling pathways involved in sustaining damage to these cells. The microarray technology serves as a tool to gain insight into the molecular pathways leading to bystander effect. Using medium from irradiated normal human diploid lung fibroblasts as a model system we examined gene expression alterations in bystander cells. The microarray data revealed that the radiation-induced gene expression profile in irradiated cells is different from unirradiated bystander cells suggesting that the pathways leading to biological effects in the bystander cells are different from the directly irradiated cells. The genes known to be responsive to ionizing radiation were observed in irradiated cells. Several genes were upregulated in cells receiving media from irradiated cells. Surprisingly no genes were found to be downregulated in these cells. A number of genes belonging to extracellular signaling, growth factors and several receptors were identified in bystander cells. Interestingly 15 genes involved in the cell communication processes were found to be upregulated. The induction of receptors and the cell

  1. Definitions and validation criteria for biomarkers and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema

    DEFF Research Database (Denmark)

    Lassere, Marissa N; Johnson, Kent R; Boers, Maarten

    2007-01-01

    endpoints, and leading indicators, a quantitative surrogate validation schema was developed and subsequently evaluated at a stakeholder workshop. RESULTS: The search identified several classification schema and definitions. Components of these were incorporated into a new quantitative surrogate validation...... of the National Institutes of Health definitions of biomarker, surrogate endpoint, and clinical endpoint was useful. CONCLUSION: Further development and application of this schema provides incentives and guidance for effective biomarker and surrogate endpoint research, and more efficient drug discovery...... are then applied if there is serious counterevidence. A total score (0 to 15) determines the level of evidence, with Level 1 the strongest and Level 5 the weakest. It was proposed that the term "surrogate" be restricted to markers attaining Levels 1 or 2 only. Most stakeholders agreed that this operationalization...

  2. Definitions and validation criteria for biomarkers and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema

    DEFF Research Database (Denmark)

    Lassere, Marissa N; Johnson, Kent R; Boers, Maarten

    2007-01-01

    endpoints, and leading indicators, a quantitative surrogate validation schema was developed and subsequently evaluated at a stakeholder workshop. RESULTS: The search identified several classification schema and definitions. Components of these were incorporated into a new quantitative surrogate validation...... level of evidence schema that evaluates biomarkers along 4 domains: Target, Study Design, Statistical Strength, and Penalties. Scores derived from 3 domains the Target that the marker is being substituted for, the Design of the (best) evidence, and the Statistical strength are additive. Penalties...... of the National Institutes of Health definitions of biomarker, surrogate endpoint, and clinical endpoint was useful. CONCLUSION: Further development and application of this schema provides incentives and guidance for effective biomarker and surrogate endpoint research, and more efficient drug discovery...

  3. Critical Joints in Large Composite Primary Aircraft Structures. Volume 3: Ancillary Test Results

    Science.gov (United States)

    Bunin, Bruce L.; Sagui, R. L.

    1985-01-01

    A program was conducted to develop the technology for critical structural joints for composite wing structure that meets all the design requirements of a 1990 commercial transport aircraft. The results of a comprehensive ancillary test program are summarized, consisting of single-bolt composite joint specimens tested in a variety of configurations. These tests were conducted to characterize the strength and load deflection properties that are required for multirow joint analysis. The composite material was Toray 300 fiber and Ciba-Geigy 914 resin, in the form of 0.005 and 0.01 inch thick unidirectional tape. Tests were conducted in single and double shear for loaded and unloaded hole configurations under both tensile and compressive loading. Two different layup patterns were examined. All tests were conducted at room temperature. In addition, the results of NASA Standard Toughness Test (NASA RP 1092) are reported, which were conducted for several material systems.

  4. Dissolved organic carbon concentration controls benthic primary production: results from in situ chambers in north-temperate lakes

    Science.gov (United States)

    Godwin, Sean C.; Jones, Stuart E.; Weidel, Brian C.; Solomon, Christopher T.

    2014-01-01

    We evaluated several potential drivers of primary production by benthic algae (periphyton) in north-temperate lakes. We used continuous dissolved oxygen measurements from in situ benthic chambers to quantify primary production by periphyton at multiple depths across 11 lakes encompassing a broad range of dissolved organic carbon (DOC) and total phosphorous (TP) concentrations. Light-use efficiency (primary production per unit incident light) was inversely related to average light availability (% of surface light) in 7 of the 11 study lakes, indicating that benthic algal assemblages exhibit photoadaptation, likely through physiological or compositional changes. DOC alone explained 86% of the variability in log-transformed whole-lake benthic production rates. TP was not an important driver of benthic production via its effects on nutrient and light availability. This result is contrary to studies in other systems, but may be common in relatively pristine north-temperate lakes. Our simple empirical model may allow for the prediction of whole-lake benthic primary production from easily obtained measurements of DOC concentration.

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

    DEFF Research Database (Denmark)

    Lynge, Elsebeth; Rebolj, Matejka

    2009-01-01

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

  6. Unmanned Aircraft Systems (UAS) Integration in the National Airspace System (NAS) Project: Terminal Operations HITL 1B Primary Results

    Science.gov (United States)

    Rorie, Conrad; Monk, Kevin; Roberts, Zach; Brandt, Summer

    2018-01-01

    This presentation provides an overview of the primary results from the Unmanned Aircraft Systems (UAS) Integration in the National Airspace System (NAS) Project's second Terminal Operations human-in-the-loop simulation. This talk covers the background of this follow-on experiment, which includes an overview of the first Terminal Operations HITL performed by the project. The primary results include a look at the number and durations of detect and avoid (DAA) alerts issued by the two DAA systems under test. It also includes response time metrics and metrics on the ability of the pilot-in-command (PIC) to maintain sufficient separation. Additional interoperability metrics are included to illustrate how pilots interact with the tower controller. Implications and conclusions are covered at the end.

  7. Targeted prevention of lifestyle related diseases in the primary care sector – results from the TOF pilot project

    DEFF Research Database (Denmark)

    Bruun Larsen, Lars; Thilsing, Trine

    This abstract reports on the results of a non-randomized pilot study carried out to test the acceptability, feasibility and short-term effects of a healthcare intervention in primary care. The intervention is designed to systematically identify persons at risk of developing lifestyle-related dise...... is facilitated by a digital support system. The pilot makes use of both quantitative and qualitative research methods....... prevention and health promotion is required. This has been attempted in past efforts by offering individual preventive health checks to the general population. However, the evidence on the effectiveness of this approach is mixed. Several systematic reviews, on the other hand, suggest that health checks......This abstract reports on the results of a non-randomized pilot study carried out to test the acceptability, feasibility and short-term effects of a healthcare intervention in primary care. The intervention is designed to systematically identify persons at risk of developing lifestyle...

  8. The results of studies of the thermohydraulics of the primary pumps in PWR reactors

    International Nuclear Information System (INIS)

    Grison, P.; Laura, J.F.

    1982-01-01

    In the context of its nuclear-safety programme for pressurized-water reactors, E.D.F. has engaged in theoretical and experimental studies in order to gain better knowledge of the behaviour of a pump under accident conditions, with passage to diphasic regime. The results of these studies are presented here, both from the experimental and theoretical points of view. They show in particular that the behaviour of the pump is essentially dictated by the interfacial friction for small flows, and by the appearance of a critical flow rate for large flows. The outline of the theoretical model describing the operation of the pump in the first three quadrants (positive and negative flow, positive and negative rotation) is described, as are certain special applications of the model, such as the determination of racing velocities in diphasic conditions [fr

  9. Results of studies of the thermohydraulics of the primary pumps in PWR reactors

    Energy Technology Data Exchange (ETDEWEB)

    Grison, P; Laura, J F [E.D.F., Chatou (France)

    1982-01-01

    In the context of its nuclear-safety program for pressurized-water reactors, E.D.F. has engaged in theoretical and experimental studies in order to gain better knowledge of the behaviour of a pump under accident conditions, with passage to diphasic regime. The results of these studies are presented here, both from the experimental and theoretical points of view. They show in particular that the behaviour of the pump is essentially dictated by the interfacial friction for small flows, and by the appearance of a critical flow rate for large flows. The outline of the theoretical model describing the operation of the pump in the first three quadrants (positive and negative flow, positive and negative rotation) is described, as are certain special applications of the model, such as the determination of racing velocities in diphasic conditions.

  10. 131I therapy of teen-age hyperthyroidism: the primary results in 46 patients

    International Nuclear Information System (INIS)

    Wang Kaiming

    2001-01-01

    Objective: To explore various conditions of teen-age hyperthyroidism with 131 I therapy. Methods: 46 patients were administrated with 131 I, the changes of T 3 and T 4 level of serum were tested by radioimmunoassay. The improvement of clinical symptoms has been observed in 46 cases with teen-age hyperthyroidism by 131 I before and after treatment. Results: 39 of 46 (84%) has been proved complete responses (CR), partial responses (PR) 7 cases. 3 months later; we found that 39 patients have hypothyroidism symptoms, T 3 and T 4 level of serum decreased. There are significance increases of TSH 23 percent patients. Conclusion: It has been proved that treatment of teen-age hyperthyroidism by 131 I is effective and safe

  11. Comparison of shipping, handling, and shock instrumentation results for two 3.5-m-class primary mirrors

    Science.gov (United States)

    Killpatrick, Don H.; Mayo, James W.

    1998-08-01

    Packing, shipping, and handling procedures employed during several transportation activities for two large telescope primary mirrors are presented along with detailed shock recording results. Operations monitored included craning, forklifting, and shipping by air, sea, and land during all phases of manufacture and installation. The mirrors monitored were the SOR 3.5-m Telescope spun cast borosilicate primary mirror and the AEOS 3.67-m Telescope Zerodur thin meniscus primary mirror. Shock recording instrumentation included 2-, 5-, and 10-g Omni-G(superscript TM) impact indicators, 10-g Impact o-graph(superscript TM) 3-axis recording accelerometers, and high-resolution 3-axis accelerometers with Astromed Dash 8 eight-channel chart recorders and audio indicators. Shock results for some operations were monitored to the 0.01-g level. In-shipment temperature data are also presented and discussed. Effects of lifting operations, road conditions via truck, flight conditions via C-5B aircraft, and transportation via sea- going barge are discussed. Data are presented for three different crate designs and configurations and, in some cases, include mirror-in-cell shipping data. Shock results were observed from as low as a few hundredths-g to over 3- g's during various operations.

  12. Sensitivity of submersed freshwater macrophytes and endpoints in laboratory toxicity tests

    International Nuclear Information System (INIS)

    Arts, Gertie H.P.; Belgers, J. Dick M.; Hoekzema, Conny H.; Thissen, Jac T.N.M.

    2008-01-01

    The toxicological sensitivity and variability of a range of macrophyte endpoints were statistically tested with data from chronic, non-axenic, macrophyte toxicity tests. Five submersed freshwater macrophytes, four pesticides/biocides and 13 endpoints were included in the statistical analyses. Root endpoints, reflecting root growth, were most sensitive in the toxicity tests, while endpoints relating to biomass, growth and shoot length were less sensitive. The endpoints with the lowest coefficients of variation were not necessarily the endpoints, which were toxicologically most sensitive. Differences in sensitivity were in the range of 10-1000 for different macrophyte-specific endpoints. No macrophyte species was consistently the most sensitive. Criteria to select endpoints in macrophyte toxicity tests should include toxicological sensitivity, variance and ecological relevance. Hence, macrophyte toxicity tests should comprise an array of endpoints, including very sensitive endpoints like those relating to root growth. - A range of endpoints is more representative of macrophyte fitness than biomass and growth only

  13. [Long-term result of total versus partial fundoplication following esophagomyotomy for primary esophageal motor disorders].

    Science.gov (United States)

    Zhu, Zi-jiang; Chen, Long-qi; Duranceau, Andre

    2008-02-15

    To compare the long-term results of total and partial fundoplication on esophagus myotomy. From January 1978 to October 1998, 64 patients with achalasia or diffuse esophageal spasm underwent esophagomyotomy and antireflux operation via left thoracotomy. Twenty-one patients underwent Nissen total fundoplication (Nissen group) and 43 patients underwent Belsey Marker IV partial fundoplication (Belsey group). Clinical, radiologic, radionuclide transit, manometric, 24-hour pH monitoring and endoscopic assessments were performed before and after the operation. There was no operative death and major complications for either group. At over 6 years follow-up and compared to Belsey group, patients in Nissen group revealed a higher frequency of dysphagia (P = 0.025) and more radionuclide material retention (P = 0.044). Both operative procedures reduced the lower esophageal sphincter pressure gradient. However, in Nissen group, the esophageal diameter observed on radiology was significantly increased from 3.9 cm preoperatively to 5.5 cm postoperatively (P = 0.012), while it kept the same for Belsey group (from 5.4 to 5.3 cm, P = 0.695). Reoperation in order to relieve the recurrent dysphagia and esophageal obstruction was performed on 8 patients in Nissen group and 1 in Belsey group (P < 0.01). When treating achalasia or diffuse esophageal spasm by esophageal myotomy and an antireflux operation, a total fundoplication is not appropriate, whereas a partial fundoplication provides proper antireflux effect without significant esophageal emptying difficulty.

  14. Cost-effectiveness of a cardiovascular disease primary prevention programme in a primary health care setting. Results of the Polish part of the EUROACTION project.

    Science.gov (United States)

    Sović, Nevena; Pająk, Andrzej; Jankowski, Piotr; Duenas, Alejandra; Kawecka-Jaszcz, Kalina; Wolfshaut-Wolak, Renata; Stepaniak, Urszula; Kawalec, Paweł

    2013-01-01

    Well designed cardiovascular disease (CVD) prevention programmes appear to be generally applicable and effective in reducing exposure to risk factors and the incidence of disease. However, introducing them broadly into clinical practice would have a significant impact on the healthcare budget, and requires careful consideration. The purpose of this health economic analysis was to assess the potential cost-effectiveness of the model nurse-led, comprehensive CVD primary prevention programme which was prepared and introduced in the EUROACTION project, in high-risk patients in Poland. A Markov model was developed to assess the long-term costs of preventive intervention. The health states modelled were: event-free (all patients at the beginning of observation), stable angina first year, acute myocardial infarction, stable angina subsequent year, myocardial infarction subsequent year, CVD death, and other causes of death. Health benefits from the reduction in risk factors were estimated based on Framingham risk function assuming the probability of defined health states according to British registers. The time horizon of the analysis was ten years, and one Markov cycle length was one year. The analysis was prepared from the healthcare payer's perspective. A willingness to pay threshold of three gross domestic product (GDP) per capita / quality-adjusted life years (QALY) was used. Univariate sensitivity analysis was conducted. Results were presented as an incremental cost-effectiveness ratio (ICER) expressed as an incremental cost per QALY. In Poland, EUROACTION intervention resulted mainly in reductions in the prevalence of smoking (by 14%) and high blood pressure (by 7%). Intervention on other risk factors, including blood lipids, was found to be less effective. Estimated ICERs were 19,524 PLN for men and 82,262 PLN for women. The programme was even more cost-effective in smokers i.e. estimated ICERs were 12,377 PLN in men and 53,471 PLN in women. The results were most

  15. The Impact of Chemoembolization Endpoints on Survival in Hepatocellular Carcinoma Patients

    Science.gov (United States)

    Jin, Brian; Wang, Dingxin; Lewandowski, Robert J.; Riaz, Ahsun; Ryu, Robert K.; Sato, Kent T.; Larson, Andrew C.; Salem, Riad; Omary, Reed A.

    2010-01-01

    OBJECTIVE To investigate the relationship between angiographic embolic endpoints of transarterial chemoembolization (TACE) and survival in patients with hepatocellular carcinoma (HCC). MATERIALS AND METHODS This study retrospectively assessed 105 patients with surgically unresectable HCC who underwent TACE. Patients were classified according to a previously established subjective angiographic chemoembolization endpoint (SACE) scale. Only one patient was classified as SACE level 1 and thus excluded from all subsequent analysis. Survival was evaluated with Kaplan-Meier analysis. Multivariate analysis with Cox’s proportional hazard regression model was used to determine independent prognostic risk factors of survival. RESULTS Overall median survival was 21.1 months (95% confidence interval [CI], 15.9–26.4). Patients embolized to SACE levels 2 and 3 were aggregated and had a significantly higher median survival (25.6 months; 95% CI, 16.2–35.0) than patients embolized to SACE level 4 (17.1 months; 95% CI, 13.3–20.9) (p = 0.035). Multivariate analysis indicated that SACE level 4 (Hazard ratio [HR], 2.49; 95% CI, 1.41–4.42; p = 0.002), European Cooperative Oncology Group performance status > 0 (HR, 1.97; 95% CI, 1.15–3.37; p = 0.013), American Joint Committee on Cancer stage 3 or 4 (HR, 2.42; 95% CI, 1.27–4.60; p = 0.007), and Child-Pugh class B (HR, 1.94; 95% CI, 1.09–3.46; p = 0.025) were all independent negative prognostic indicators of survival. CONCLUSION Embolization to an intermediate, sub-stasis endpoint (SACE levels 2 and 3) during TACE improves survival compared to embolization to a higher, stasis endpoint (SACE level 4). Interventional oncologists should consider targeting these intermediate, sub-stasis angiographic endpoints during TACE. PMID:21427346

  16. Data Processing and Primary results of Lunar Penetrating Radar on Board the Chinese Yutu Rover

    Science.gov (United States)

    Su, Yan; Xing, Shuguo; Feng, Jianqing; Dai, Shun; Ding, Chunyu; Xiao, Yuan; Zhang, Hongbo; Zhao, Shu; Xue, Xiping; Zhang, Xiaoxia; Liu, Bin; Yao, Meijuan; Li, Chunlai

    2015-04-01

    60MHz and tens of meters at 500MHz. Based on the previous lunar subsurface research and Apollo samples analysis, the dielectric constantɛr of the lunar rock is set to be 7 and the dielectric constantɛr of the lunar regolith is set to be 3.1 The LPR observations reveal that Mare Imbrium has subsurface stratifications. The regolith is not uniform and structures with multiple layers have been observed. The results indicate the thickness of the regolith is 4-6 m. The typical hyperbolic shapes that might be caused by rocks underneath the regolith have been found. Furthermore, several prominent reflective layers at depths of hundreds of meters have been clearly derived. The buried regolith layer might have been accumulated during the depositional hiatus of mare basalts.

  17. The Comparison of the Outcomes between Primary PCI, Fibrinolysis, and No Reperfusion in Patients ≥ 75 Years Old with ST-Segment Elevation Myocardial Infarction: Results from the Chinese Acute Myocardial Infarction (CAMI Registry.

    Directory of Open Access Journals (Sweden)

    He Peiyuan

    Full Text Available Only a few randomized trials have analyzed the clinical outcomes of elderly ST-segment elevation myocardial infarction (STEMI patients (≥ 75 years old. Therefore, the best reperfusion strategy has not been well established. An observational study focused on clinical outcomes was performed in this population.Based on the national registry on STEMI patients, the in-hospital outcomes of elderly patients with different reperfusion strategies were compared. The primary endpoint was defined as death. Secondary endpoints included recurrent myocardial infarction, ischemia driven revascularization, myocardial infarction related complications, and major bleeding. Multivariable regression analysis was performed to adjust for the baseline disparities between the groups.Patients who had primary percutaneous coronary intervention (PCI or fibrinolysis were relatively younger. They came to hospital earlier, and had lower risk of death compared with patients who had no reperfusion. The guideline recommended medications were more frequently used in patients with primary PCI during the hospitalization and at discharge. The rates of death were 7.7%, 15.0%, and 19.9% respectively, with primary PCI, fibrinolysis, and no reperfusion (P 0.05. In the multivariable regression analysis, primary PCI outweighs no reperfusion in predicting the in-hospital death in patients ≥ 75 years old. However, fibrinolysis does not.Early reperfusion, especially primary PCI was safe and effective with absolute reduction of mortality compared with no reperfusion. However, certain randomized trials were encouraged to support the conclusion.

  18. Application of a LiFePO4 Battery Energy Storage System to Primary Frequency Control: Simulations and Experimental Results

    Directory of Open Access Journals (Sweden)

    Fabio Massimo Gatta

    2016-10-01

    Full Text Available This paper presents an experimental application of LiFePO4 battery energy storage systems (BESSs to primary frequency control, currently being performed by Terna, the Italian transmission system operator (TSO. BESS performance in the primary frequency control role was evaluated by means of a simplified electrical-thermal circuit model, taking into account also the BESS auxiliary consumptions, coupled with a cycle-life model, in order to assess the expected life of the BESS. Numerical simulations have been carried out considering the system response to real frequency measurements taken in Italy, spanning a whole year; a parametric study taking into account different values of governor droop and of BESS charge/discharge rates (C-rates was also performed. Simulations, fully validated by experimental results obtained thus far, evidenced a severe trade-off between expected lifetime and overall efficiency, which significantly restricts the choice of operating parameters for frequency control.

  19. The Impact of a Primary Care Education Program Regarding Cancer Survivorship Care Plans: Results from an Engineering, Primary Care, and Oncology Collaborative for Survivorship Health.

    Science.gov (United States)

    Donohue, SarahMaria; Haine, James E; Li, Zhanhai; Trowbridge, Elizabeth R; Kamnetz, Sandra A; Feldstein, David A; Sosman, James M; Wilke, Lee G; Sesto, Mary E; Tevaarwerk, Amye J

    2017-09-20

    Survivorship care plans (SCPs) have been recommended as tools to improve care coordination and outcomes for cancer survivors. SCPs are increasingly being provided to survivors and their primary care providers. However, most primary care providers remain unaware of SCPs, limiting their potential benefit. Best practices for educating primary care providers regarding SCP existence and content are needed. We developed an education program to inform primary care providers of the existence, content, and potential uses for SCPs. The education program consisted of a 15-min presentation highlighting SCP basics presented at mandatory primary care faculty meetings. An anonymous survey was electronically administered via email (n = 287 addresses) to evaluate experience with and basic knowledge of SCPs pre- and post-education. A total of 101 primary care advanced practice providers (APPs) and physicians (35% response rate) completed the baseline survey with only 23% reporting prior receipt of a SCP. Only 9% could identify the SCP location within the electronic health record (EHR). Following the education program, primary care physicians and APPs demonstrated a significant improvement in SCP knowledge, including improvement in their ability to locate one within the EHR (9 vs 59%, p educational program containing information about SCP existence, content, and location in the EHR increased primary care physician and APP knowledge in these areas, which are prerequisites for using SCP in clinical practice.

  20. Clinical endpoint adjudication in a contemporary all-comers coronary stent investigation: methodology and external validation.

    Science.gov (United States)

    Vranckx, Pascal; McFadden, Eugene; Cutlip, Donald E; Mehran, Roxana; Swart, Michael; Kint, P P; Zijlstra, Felix; Silber, Sigmund; Windecker, Stephan; Serruys, Patrick W C J

    2013-01-01

    Globalisation in coronary stent research calls for harmonization of clinical endpoint definitions and event adjudication. Little has been published about the various processes used for event adjudication or their impact on outcome reporting. We performed a validation of the clinical event committee (CEC) adjudication process on 100 suspected events in the RESOLUTE All-comers trial (Resolute-AC). Two experienced Clinical Research Organisations (CRO) that had already extensive internal validation processes in place, participated in the study. After initial adjudication by the primary-CEC, events were cross-adjudicated by an external-CEC using the same definitions. Major discrepancies affecting the primary end point of target-lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically-indicated target-lesion revascularization (CI-TLR), were analysed by an independent oversight committee who provided recommendations for harmonization. Discordant adjudications were reconsidered by the primary CEC. Subsequently, the RAC database was interrogated for cases that based on these recommendations merited re-adjudication and these cases were also re-adjudicated by the primary CEC. Final discrepancies in adjudication of individual components of TLF occurred in 7 out of 100 events in 5 patients. Discrepancies for the (hierarchical) primary endpoint occurred in 5 events (2 cardiac deaths and 3 TV-MI). After application of harmonization recommendations to the overall RAC population (n=2292), the primary CEC adjudicated 3 additional clinical-TLRs and considered 1 TV-MI as no event. A harmonization process provided a high level of concordance for event adjudication and improved accuracy for final event reporting. These findings suggest it is feasible to pool clinical event outcome data across clinical trials even when different CECs are responsible for event adjudication. Copyright © 2012 Elsevier Inc. All rights reserved.

  1. The Asthma Control Questionnaire as a clinical trial endpoint

    DEFF Research Database (Denmark)

    Barnes, P J; Casale, T B; Dahl, Ronald

    2014-01-01

    these component endpoints; however, there is no consensus on the optimal instrument for use in clinical trials. The Asthma Control Questionnaire (ACQ) has been shown to be a valid, reliable instrument that allows accurate and reproducible assessment of asthma control that compares favourably with other commonly...

  2. Early results of Latitude primary total elbow replacement with a minimum follow-up of 2 years.

    Science.gov (United States)

    Mehta, Saurabh S; Watts, Adam C; Talwalkar, Sumedh C; Birch, Ann; Nuttall, David; Trail, Ian A

    2017-10-01

    The aim of this study was to present outcomes of primary Latitude total elbow replacement (TER) with a minimum follow-up of 2 years. A retrospective cohort study was undertaken with prospective outcome data collection for the latest outcome. Included were 63 consecutive primary Latitude TERs in 58 patients performed during a period of 5 years at a specialist orthopedic hospital. The mean age of the patients was 62 years (33-85 years). Five primary TERs (4 patients) were lost to follow-up. The primary diagnosis was rheumatoid arthritis in 49, osteoarthritis in 8, and trauma in 6 elbows. The mean flexion-extension arc was 75° preoperatively and 97° postoperatively. Mean postoperative Elbex pain score was 19/100, and function score was 37/100. Mean postoperative scores were 42/100 for the Quick Disabilities of the Arm, Shoulder, and Hand and 38/50 for the elbow-specific American Shoulder and Elbow Surgeons assessment. Four patients died of unrelated causes, and 8 of 63 underwent further surgical intervention, including explantation and conversion from unlinked to linked implant. On radiographic review of 41 surviving TERs, aseptic radiologic loosening was observed of the humeral component in 4 elbows and of the ulnar component in 9. Seven elbows had no radial component, and of the remaining 34 elbows, 16 (47%) had signs of loosening of the radial implant. Complications included 1 heterotopic ossification, 1 olecranon fracture, and 3 further procedures for ulnar nerve entrapment. The results indicate that the early outcome of Latitude TER is comparable to that of other prostheses. There is concern about early radiologic loosening of the radial component. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

  3. Carbon ion radiotherapy for localized primary sarcoma of the extremities: Results of a phase I/II trial

    International Nuclear Information System (INIS)

    Sugahara, Shinji; Kamada, Tadashi; Imai, Reiko; Tsuji, Hiroshi; Kameda, Noriaki; Okada, Tohru; Tsujii, Hirohiko; Tatezaki, Shinichirou

    2012-01-01

    Purpose: To determine the effectiveness of carbon ion radiotherapy (CIRT) for localized primary sarcomas of the extremities in a prospective study. Patients and materials: From April 2000 to May 2010, 17 (male/female: 12/5) patients with localized primary sarcoma of the extremities received CIRT. The median age was 53 years (range: 14–87 years). Nine patients had primary diseases and eight had recurrent diseases. Of the 17 patients, eight refused amputation, and the remaining nine refused surgical resection. Tumors were located in the upper limbs in four patients and lower limbs in 13. Histological diagnosis was osteosarcoma in three patients, liposarcoma in two, synovial sarcoma in two, rhabdomyosarcoma in two, pleomorphic sarcoma in two, and miscellaneous in six. The CIRT dose to the limb was 52.8 GyE for one patient, 64 GyE for three, 70.4 GyE for 13 in 16 fixed fractions over 4 weeks. Records were reviewed and outcomes including radiologic response, local control (progression-free), and survival were analyzed. Results: The median follow-up was 37 months (range: 11–97 months). Radiological response rate was 65% (PR in 11, SD in 5, and PD in 1). The local control rate at 5 years was 76%. The overall survival rate at 5 years was 56%. Of the 17 patients, 10 survived without disease progression. Four patients had local recurrences, one was salvaged by repeated CIRT and the other three died due to systemic diseases. Distant failure was observed in six patients. One patient suffered from femoral fracture (grade 3) and received surgical fixation 27 months after CIRT. No other severe reactions (grade 3) were observed. Conclusions: CIRT is suggested to be an effective and safe treatment for patients who refuse surgery for localized primary sarcomas of the extremities.

  4. Integrated PET/MRI for whole-body staging of patients with primary cervical cancer: preliminary results

    Energy Technology Data Exchange (ETDEWEB)

    Grueneisen, Johannes; Kinner, Sonja; Forsting, Michael; Lauenstein, Thomas; Umutlu, Lale [University Hospital Essen, University of Duisburg-Essen, Department of Diagnostic and Interventional Radiology and Neuroradiology, Essen (Germany); Schaarschmidt, Benedikt Michael [University Hospital Dusseldorf, University of Dusseldorf, Department of Diagnostic and Interventional Radiology, Dusseldorf (Germany); Heubner, Martin; Aktas, Bahriye [University Hospital Essen, University of Duisburg-Essen, Department of Obstetrics and Gynecology, Essen (Germany); Ruhlmann, Verena [University Hospital Essen, University of Duisburg-Essen, Department of Nuclear Medicine, Essen (Germany)

    2015-11-15

    To assess the diagnostic value of integrated PET/MRI for whole-body staging of cervical cancer patients, as well as to investigate a potential association between PET/MRI derived functional parameters and prognostic factors of cervical cancer. The present study was approved by the local institutional review board. Twenty-seven patients with histopathologically confirmed cervical cancer were prospectively enrolled in our study. All patients underwent a whole-body PET/MRI examination after written informed consent was obtained. Two radiologists separately evaluated the PET/MRI data sets regarding the determination of local tumor extent of primary cervical cancer lesions, as well as detection of nodal and distant metastases. Furthermore, SUV and ADC values of primary tumor lesions were analyzed and correlated with dedicated prognostic factors of cervical cancer. Results based on histopathology and cross-sectional imaging follow-up served as the reference standard. PET/MRI enabled the detection of all 27 primary tumor lesions of the uterine cervix and allowed for the correct determination of the T-stage in 23 (85 %) out of the 27 patients. Furthermore, the calculated sensitivity, specificity and diagnostic accuracy for the detection of nodal positive patients (n = 11) were 91 %, 94 % and 93 %, respectively. PET/MRI correctly identified regional metastatic disease (N1-stage) in 8/10 (80 %) patients and non-regional lymph node metastases in 5/5 (100 %) patients. In addition, quantitative analysis of PET and MRI derived functional parameters (SUV; ADC values) revealed a significant correlation with pathological grade and tumor size (p < 0.05). The present study demonstrates the high potential of integrated PET/MRI for the assessment of primary tumor and the detection of lymph node metastases in patients with cervical cancer. Providing additional prognostic information, PET/MRI may serve as a valuable diagnostic tool for cervical cancer patients in a pretreatment setting

  5. Integrated PET/MRI for whole-body staging of patients with primary cervical cancer: preliminary results

    International Nuclear Information System (INIS)

    Grueneisen, Johannes; Kinner, Sonja; Forsting, Michael; Lauenstein, Thomas; Umutlu, Lale; Schaarschmidt, Benedikt Michael; Heubner, Martin; Aktas, Bahriye; Ruhlmann, Verena

    2015-01-01

    To assess the diagnostic value of integrated PET/MRI for whole-body staging of cervical cancer patients, as well as to investigate a potential association between PET/MRI derived functional parameters and prognostic factors of cervical cancer. The present study was approved by the local institutional review board. Twenty-seven patients with histopathologically confirmed cervical cancer were prospectively enrolled in our study. All patients underwent a whole-body PET/MRI examination after written informed consent was obtained. Two radiologists separately evaluated the PET/MRI data sets regarding the determination of local tumor extent of primary cervical cancer lesions, as well as detection of nodal and distant metastases. Furthermore, SUV and ADC values of primary tumor lesions were analyzed and correlated with dedicated prognostic factors of cervical cancer. Results based on histopathology and cross-sectional imaging follow-up served as the reference standard. PET/MRI enabled the detection of all 27 primary tumor lesions of the uterine cervix and allowed for the correct determination of the T-stage in 23 (85 %) out of the 27 patients. Furthermore, the calculated sensitivity, specificity and diagnostic accuracy for the detection of nodal positive patients (n = 11) were 91 %, 94 % and 93 %, respectively. PET/MRI correctly identified regional metastatic disease (N1-stage) in 8/10 (80 %) patients and non-regional lymph node metastases in 5/5 (100 %) patients. In addition, quantitative analysis of PET and MRI derived functional parameters (SUV; ADC values) revealed a significant correlation with pathological grade and tumor size (p < 0.05). The present study demonstrates the high potential of integrated PET/MRI for the assessment of primary tumor and the detection of lymph node metastases in patients with cervical cancer. Providing additional prognostic information, PET/MRI may serve as a valuable diagnostic tool for cervical cancer patients in a pretreatment setting

  6. Co- and multimorbidity patterns in primary care based on episodes of care: results from the German CONTENT project

    Directory of Open Access Journals (Sweden)

    Rosemann Thomas

    2008-01-01

    Full Text Available Abstract Background Due to technological progress and improvements in medical care and health policy the average age of patients in primary care is continuously growing. In equal measure, an increasing proportion of mostly elderly primary care patients presents with multiple coexisting medical conditions. To properly assess the current situation of co- and multimorbidity, valid scientific data based on an appropriate data structure are indispensable. CONTENT (CONTinuous morbidity registration Epidemiologic NeTwork is an ambitious project in Germany to establish a system for adequate record keeping and analysis in primary care based on episodes of care. An episode is defined as health problem from its first presentation by a patient to a doctor until the completion of the last encounter for it. The study aims to describe co- and multimorbidity as well as health care utilization based on episodes of care for the study population of the first participating general practices. Methods The analyses were based on a total of 39,699 patients in a yearly contact group (YCG out of 17 general practices in Germany for which data entry based on episodes of care using the International Classification of Primary Care (ICPC was performed between 1.1.2006 and 31.12.2006. In order to model the relationship between the explanatory variables (age, gender, number of chronic conditions and the response variables of interest (number of different prescriptions, number of referrals, number of encounters that were applied to measure health care utilization, we used multiple linear regression. Results In comparison to gender, patients' age had a manifestly stronger impact on the number of different prescriptions, the number of referrals and number of encounters. In comparison to age (β = 0.043, p Conclusion Documentation in primary care on the basis of episodes of care facilitates an insight to concurrently existing health problems and related medical procedures

  7. A patient and community-centered approach selecting endpoints for a randomized trial of a novel advance care planning tool

    Directory of Open Access Journals (Sweden)

    Bridges JFP

    2018-02-01

    Full Text Available John FP Bridges,1,2 Norah L Crossnohere,2 Anne L Schuster,1 Judith A Miller,3 Carolyn Pastorini,3,† Rebecca A Aslakson2,4,5 1Department of Health Policy and Management, The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 2Department of Health, Behavior, and Society, The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 3Patient-Centered Outcomes Research Institute (PCORI Project, Baltimore, MD, 4Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins School of Medicine, Baltimore, MD, 5Armstrong Institute for Patient Safety and Quality, The Johns Hopkins School of Medicine, Baltimore, MD, USA †Carolyn Pastorini passed away on August 24, 2015 Background: Despite a movement toward patient-centered outcomes, best practices on how to gather and refine patients’ perspectives on research endpoints are limited. Advanced care planning (ACP is inherently patient centered and would benefit from patient prioritization of endpoints for ACP-related tools and studies.Objective: This investigation sought to prioritize patient-centered endpoints for the content and evaluation of an ACP video being developed for patients undergoing major surgery. We also sought to highlight an approach using complementary engagement and research strategies to document priorities and preferences of patients and other stakeholders.Materials and methods: Endpoints identified from a previously published environmental scan were operationalized following rating by a caregiver co-investigator, refinement by a patient co-investigator, review by a stakeholder committee, and validation by patients and family members. Finalized endpoints were taken to a state fair where members of the public who indicated that they or a loved one had undergone major surgery prioritized their most relevant endpoints and provided comments.Results: Of the initial 50 ACP endpoints identified from the review, 12 endpoints were selected for public

  8. Consensus of microbiology reporting of ear swab results to primary care clinicians in patients with otitis externa.

    Science.gov (United States)

    Geyer, M; Howell-Jones, R; Cunningham, R; McNulty, C

    2011-01-01

    Otitis externa is a ubiquitous inflammatory disease; although it arises most commonly from an infection, there is no consensus in the UK for the reporting of ear swab culture results. This study aims to review current microbiology laboratory reporting of ear swab specimens to primary care and reach an evidence-based consensus for a reporting policy. Fifty consecutive ear swab reports were reviewed from each of 12 laboratories in the South West region to determine and discuss reporting practice. The Health Protection Agency (HPA) GP Microbiology Laboratory Use Group reviewed the underlying evidence and worked towards a consensus of expert microbiology opinion for laboratory reporting of ear swab results using a modified version of the Delphi technique. A total of 487 reports from primary care were reviewed (54% female; 46% male). Cultures most commonly yielded Pseudomonas species (36%), Staphylococcus species (21%), Streptococcus species (15%) and fungi (11%). Five reporting policies were agreed: Policy 1: Common pathogens such as group A beta-haemolytic streptococci, Streptococcus pneumoniae, Staphylococcus aureus - Always reported by name with antibiotic susceptibilities. Policy 2: Pseudomonas species - Always reported, but antibiotic susceptibilities only reported in severe disease. Policy 3: Aspergillus, Candida, coliforms and Proteus species, as well as non-group A streptococci and anaerobes - Only reported if moderate numbers of colonies and it is the predominant organism present; if appropriate report antibiotic susceptibilities. Policy 4: Coagulase-negative staphylococci, diphtheroids and enterococci - Not reported by name; generic terms used and antibiotic susceptibilities not reported. Policy 5: When antibiotic susceptibilities reported these must include susceptibility to a topical antibiotic. It is suggested that laboratories should consider adopting this evidence-based reporting consensus for ear swab culture results from primary care patients with

  9. Plasma TIMP-1 and CEA as markers for detection of primary colorectal cancer

    DEFF Research Database (Denmark)

    Christensen, Ib Jarle; Brünner, Nils; Dowell, Barry

    2015-01-01

    endoscopy were prospectively included (N=1965). Baseline data and co-morbidity were recorded. The primary end-point was the detection of CRC. Plasma was obtained before endoscopy and TIMP-1 and CEA levels were determined using an automated analysis platform when all samples were collected. RESULTS: CRC...

  10. Valve stem packing seal test results for primary heat transport system conditions in Canadian nuclear generating stations

    International Nuclear Information System (INIS)

    Dixon, D.F.; Farrell, J.M.; Coutinho, R.F.

    1978-06-01

    Valve stem packing tests were done to obtain performance data on packing already in CANDU-PHW reactor service and on alternative packings. Most of the tests were replicated. Results are presented for ten packings tested under two stem cycle modes; leakage, packing consolidation and packing friction were the main responses. Packing tests were performed with water at close to CANDU-PHW reactor primary heat transport (PHT) system conditions (288 deg C and 10 MPa), but without ionizing radiation. The test rigs had rising, rotating stems. Stuffing box dimensions were typical of a standard Velan valve; packings were spring loaded to control applied packing stress

  11. Whole-brain radiotherapy and high-dose methylprednisolone for elderly patients with primary central nervous system lymphoma: Results of North Central Cancer Treatment Group (NCCTG) 96-73-51

    International Nuclear Information System (INIS)

    Laack, Nadia N.; Ballman, Karla V.; Brown, Paul B.; O'Neill, Brian Patrick

    2006-01-01

    Purpose: The aim of this study was to evaluate the efficacy, toxicity, and survival of whole-brain radiotherapy-treated (WBRT) and high-dose methylprednisolone (HDMP)-treated in elderly patients with primary central nervous system lymphoma (PCNSL). Methods and Materials: Patients with PCNSL who were 70 years and older received 1 g of methylprednisolone daily for 5 days, 30 days after WBRT. Patients then received 1 g of methylprednisolone every 28 days until progression. The primary endpoint was overall survival (OS) at 6 months. Results were compared with those in patients on the previous North Central Cancer Treatment Group (NCCTG) trial who received pre-WBRT cytoxan, adriamycin, vincristine, prednisone (CHOP) and high-dose cytarabine (CHOP-WBRT). A planned interim analysis was performed. The current regimen would be considered inactive if survival was not improved from patients treated with CHOP-WBRT. Results: Nineteen patients were accrued between 1998 and 2003. Median age was 76 years. Interim analysis revealed a 6-month survival of 33%, resulting in closure of the trial. Toxicity, OS, and event-free survival (EFS) were similar to those in patients more than 70 years of age who received CHOP-WBRT. The subgroup of patients who received HDMP had longer OS (12.1 vs. 7.0 months, p = 0.76) and EFS (11.7 vs. 4.0 months, p = 0.04) compared with the CHOP-WBRT patients alive 60 days after the start of treatment. Conclusions: Patients on-study long enough to receive HDMP had prolongation of OS and EFS compared to patients receiving CHOP-WBRT. Although the numbers of patients are too small for statistical conclusions, the HDMP regimen deserves further study

  12. Clinical results of primary malignant musculoskeletal tumor treated by wide resection and recycling autograft reconstruction using liquid nitrogen.

    Science.gov (United States)

    Paholpak, Permsak; Sirichativapee, Winai; Wisanuyotin, Taweechok; Kosuwon, Weerachai; Jeeravipoolvarn, Polasak

    2015-06-01

    To evaluate the clinical results of primary malignant musculoskeletal tumors treated with wide resection and recycling autograft reconstruction using liquid nitrogen. We reviewed 12 patients who had a primary malignant bone and soft tissue tumor treated by wide resection and recycling autograft reconstruction using liquid nitrogen between March 2006 and March 2013. The results were judged by recurrence, functional status and complications. Functional status was assessed according to the Musculoskeletal Tumor Society Score (MSTSS). Clinical failure was defined as need for reoperation in order to change the type of reconstruction or to amputate, and the presence of local recurrence. The most common tumor was osteosarcoma (eight cases) followed by Ewing's sarcoma (two cases). The tibia was the most frequently involved skeletal site (six cases) followed by the femur (three cases). The median follow-up period was 32 months. In 12 patients, 7 were still alive without recurrence. There were 3 clinical failures: 1 local recurrence and 2 graft complications at 28, 51 and 20 months after reconstruction, respectively. The main complication was infection (three cases). All osteotomy sites were radiographic unions, and the union time was 8.2 ± 2.7 months. The mean ± SD MSTSS score was 79% ± 11%; excellent functional results were achieved in seven patients. Recycling autograft reconstruction using liquid nitrogen had favorable clinical outcomes in terms of functional status and local recurrence. This reconstruction method, therefore, represents a reasonable alternative for limb salvage surgery. © 2014 Wiley Publishing Asia Pty Ltd.

  13. Life prediction of simple structures subject to cyclic primary and secondary loading resulting in creep and platicity

    International Nuclear Information System (INIS)

    Otter, N.R.; Jones, R.T.

    1979-01-01

    High temperature reactors are subject to cyclic mechanical and thermal loadings resulting from start up and shut down operations. The design must therefore guard against structural failure resulting from excessive deformation and creep-fatigue damage. Before any simplified inelastic analysis techniques can be applied, their validity needs to be examined under situations representative of the reactor. For this to be carried out it is necessary to determine the behaviour of components, initially geometrically simple, subject to loadings, cyclic primary and secondary in nature, which result in creep and plasticity. Beam-like structures have been investigated on a finite element basis with the aim of determining how cyclic plasticity, creep enhancement and plastic ratchetting vary in relationship with modified shakedown criteria, magnitude of loading and hold time. (orig.)

  14. Results of the Croatian Primary Percutaneous Coronary Intervention Network for patients with ST-segment elevation acute myocardial infarction.

    Science.gov (United States)

    Nikolić Heitzler, Vjeran; Babic, Zdravko; Milicic, Davor; Bergovec, Mijo; Raguz, Miroslav; Mirat, Jure; Strozzi, Maja; Plazonic, Zeljko; Giunio, Lovel; Steiner, Robert; Starcevic, Boris; Vukovic, Ivica

    2010-05-01

    The Republic of Croatia, with a gross domestic product per capita of US$11,554 in 2008, is an economically less-developed Western country. The goal of the present investigation was to prove that a well-organized primary percutaneous coronary intervention network in an economically less-developed country equalizes the prospects of all patients with acute ST-segment elevation myocardial infarction at a level comparable to that of more economically developed countries. We prospectively investigated 1,190 patients with acute ST-segment elevation myocardial infarction treated with primary PCI in 8 centers across Croatia (677 nontransferred and 513 transferred). The postprocedural Thrombolysis In Myocardial Infarction flow, in-hospital mortality, and incidence of major adverse cardiovascular events (ie, mortality, pectoral angina, restenosis, reinfarction, coronary artery bypass graft, and cerebrovascular accident rate) during 6 months of follow-up were compared between the nontransferred and transferred subgroups and in the subgroups of older patients, women, and those with cardiogenic shock. In all investigated patients, the average door-to-balloon time was 108 minutes, and the total ischemic time was 265 minutes. Postprocedural Thrombolysis In Myocardial Infarction 3 flow was established in 87.1% of the patients, and the in-hospital mortality rate was 4.4%. No statistically significant difference was found in the results of treatment between the transferred and nontransferred patients overall or in the subgroups of patients >75 years, women, and those with cardiogenic shock. In conclusion, the Croatian Primary Percutaneous Coronary Intervention Network has ensured treatment results of acute ST-segment elevation myocardial infarction comparable to those of randomized studies and registries of more economically developed countries. Copyright 2010 Elsevier Inc. All rights reserved.

  15. Transmission assessment surveys (TAS to define endpoints for lymphatic filariasis mass drug administration: a multicenter evaluation.

    Directory of Open Access Journals (Sweden)

    Brian K Chu

    Full Text Available BACKGROUND: Lymphatic filariasis (LF is targeted for global elimination through treatment of entire at-risk populations with repeated annual mass drug administration (MDA. Essential for program success is defining and confirming the appropriate endpoint for MDA when transmission is presumed to have reached a level low enough that it cannot be sustained even in the absence of drug intervention. Guidelines advanced by WHO call for a transmission assessment survey (TAS to determine if MDA can be stopped within an LF evaluation unit (EU after at least five effective rounds of annual treatment. To test the value and practicality of these guidelines, a multicenter operational research trial was undertaken in 11 countries covering various geographic and epidemiological settings. METHODOLOGY: The TAS was conducted twice in each EU with TAS-1 and TAS-2 approximately 24 months apart. Lot quality assurance sampling (LQAS formed the basis of the TAS survey design but specific EU characteristics defined the survey site (school or community, eligible population (6-7 year olds or 1(st-2(nd graders, survey type (systematic or cluster-sampling, target sample size, and critical cutoff (a statistically powered threshold below which transmission is expected to be no longer sustainable. The primary diagnostic tools were the immunochromatographic (ICT test for W. bancrofti EUs and the BmR1 test (Brugia Rapid or PanLF for Brugia spp. EUs. PRINCIPAL FINDINGS/CONCLUSIONS: In 10 of 11 EUs, the number of TAS-1 positive cases was below the critical cutoff, indicating that MDA could be stopped. The same results were found in the follow-up TAS-2, therefore, confirming the previous decision outcome. Sample sizes were highly sex and age-representative and closely matched the target value after factoring in estimates of non-participation. The TAS was determined to be a practical and effective evaluation tool for stopping MDA although its validity for longer-term post

  16. Transmission assessment surveys (TAS) to define endpoints for lymphatic filariasis mass drug administration: a multicenter evaluation.

    Science.gov (United States)

    Chu, Brian K; Deming, Michael; Biritwum, Nana-Kwadwo; Bougma, Windtaré R; Dorkenoo, Améyo M; El-Setouhy, Maged; Fischer, Peter U; Gass, Katherine; Gonzalez de Peña, Manuel; Mercado-Hernandez, Leda; Kyelem, Dominique; Lammie, Patrick J; Flueckiger, Rebecca M; Mwingira, Upendo J; Noordin, Rahmah; Offei Owusu, Irene; Ottesen, Eric A; Pavluck, Alexandre; Pilotte, Nils; Rao, Ramakrishna U; Samarasekera, Dilhani; Schmaedick, Mark A; Settinayake, Sunil; Simonsen, Paul E; Supali, Taniawati; Taleo, Fasihah; Torres, Melissa; Weil, Gary J; Won, Kimberly Y

    2013-01-01

    Lymphatic filariasis (LF) is targeted for global elimination through treatment of entire at-risk populations with repeated annual mass drug administration (MDA). Essential for program success is defining and confirming the appropriate endpoint for MDA when transmission is presumed to have reached a level low enough that it cannot be sustained even in the absence of drug intervention. Guidelines advanced by WHO call for a transmission assessment survey (TAS) to determine if MDA can be stopped within an LF evaluation unit (EU) after at least five effective rounds of annual treatment. To test the value and practicality of these guidelines, a multicenter operational research trial was undertaken in 11 countries covering various geographic and epidemiological settings. The TAS was conducted twice in each EU with TAS-1 and TAS-2 approximately 24 months apart. Lot quality assurance sampling (LQAS) formed the basis of the TAS survey design but specific EU characteristics defined the survey site (school or community), eligible population (6-7 year olds or 1(st)-2(nd) graders), survey type (systematic or cluster-sampling), target sample size, and critical cutoff (a statistically powered threshold below which transmission is expected to be no longer sustainable). The primary diagnostic tools were the immunochromatographic (ICT) test for W. bancrofti EUs and the BmR1 test (Brugia Rapid or PanLF) for Brugia spp. EUs. In 10 of 11 EUs, the number of TAS-1 positive cases was below the critical cutoff, indicating that MDA could be stopped. The same results were found in the follow-up TAS-2, therefore, confirming the previous decision outcome. Sample sizes were highly sex and age-representative and closely matched the target value after factoring in estimates of non-participation. The TAS was determined to be a practical and effective evaluation tool for stopping MDA although its validity for longer-term post-MDA surveillance requires further investigation.

  17. Resource Utilisation and Costs of Depressive Patients in Germany: Results from the Primary Care Monitoring for Depressive Patients Trial

    Directory of Open Access Journals (Sweden)

    Christian Krauth

    2014-01-01

    Full Text Available Background. Depression is the most common type of mental disorder in Germany. It is associated with a high level of suffering for individuals and imposes a significant burden on society. The aim of this study was to estimate the depression related costs in Germany taking a societal perspective. Materials and Methods. Data were collected from the primary care monitoring for depressive patients trial (PRoMPT of patients with major depressive disorder who were treated in a primary care setting. Resource utilisation and days of sick leave were observed and analysed over a 1-year period. Results. Average depression related costs of €3813 were calculated. Significant differences in total costs due to sex were demonstrated. Male patients had considerable higher total costs than female patients, whereas single cost categories did not differ significantly. Further, differences in costs according to severity of disease and age were observed. The economic burden to society was estimated at €15.6 billion per year. Conclusion. The study results show that depression poses a significant economic burden to society. There is a high potential for prevention, treatment, and patient management innovations to identify and treat patients at an early stage.

  18. End-point impedance measurements across dominant and nondominant hands and robotic assistance with directional damping.

    Science.gov (United States)

    Erden, Mustafa Suphi; Billard, Aude

    2015-06-01

    The goal of this paper is to perform end-point impedance measurements across dominant and nondominant hands while doing airbrush painting and to use the results for developing a robotic assistance scheme. We study airbrush painting because it resembles in many ways manual welding, a standard industrial task. The experiments are performed with the 7 degrees of freedom KUKA lightweight robot arm. The robot is controlled in admittance using a force sensor attached at the end-point, so as to act as a free-mass and be passively guided by the human. For impedance measurements, a set of nine subjects perform 12 repetitions of airbrush painting, drawing a straight-line on a cartoon horizontally placed on a table, while passively moving the airbrush mounted on the robot's end-point. We measure hand impedance during the painting task by generating sudden and brief external forces with the robot. The results show that on average the dominant hand displays larger impedance than the nondominant in the directions perpendicular to the painting line. We find the most significant difference in the damping values in these directions. Based on this observation, we develop a "directional damping" scheme for robotic assistance and conduct a pilot study with 12 subjects to contrast airbrush painting with and without robotic assistance. Results show significant improvement in precision with both dominant and nondominant hands when using robotic assistance.

  19. Trial endpoints for drug approval in oncology: Chemoprevention.

    Science.gov (United States)

    Beitz, J

    2001-04-01

    As with other drugs, new drug applications for marketing approval of chemopreventive drugs must include data from adequate and well-controlled clinical trials that demonstrate effectiveness and safety for the intended use. This article summarizes the regulatory requirements for traditional marketing approval, as well as for approval under the accelerated approval regulations. Unlike traditional approval, accelerated approval is based on a surrogate endpoint that is reasonably likely to predict clinical benefit. Discussions with the Food and Drug Administration (FDA) regarding the validity of trial endpoints that may serve as surrogates for clinical benefit for accelerated approval should take place as early as possible in drug development. Meetings with the FDA to discuss these issues may be requested throughout the clinical development of a new drug.

  20. Identification and content validation of wound therapy clinical endpoints relevant to clinical practice and patient values for FDA approval. Part 1. Survey of the wound care community.

    Science.gov (United States)

    Driver, Vickie R; Gould, Lisa J; Dotson, Peggy; Gibbons, Gary W; Li, William W; Ennis, William J; Kirsner, Robert S; Eaglstein, William H; Bolton, Laura L; Carter, Marissa J

    2017-05-01

    Wounds that exhibit delayed healing add extraordinary clinical, economic, and personal burdens to patients, as well as to increasing financial costs to health systems. New interventions designed to ease such burdens for patients with cancer, renal, or ophthalmologic conditions are often cleared for approval by the U.S. Food and Drug Administration (FDA) using multiple endpoints but the requirement of complete healing as a primary endpoint for wound products impedes FDA clearance of interventions that can provide other clinical or patient-centered benefits for persons with wounds. A multidisciplinary group of wound experts undertook an initiative, in collaboration with the FDA, to identify and content validate supporting FDA criteria for qualifying wound endpoints relevant to clinical practice (CP) and patient-centered outcomes (PCO) as primary outcomes in clinical trials. As part of the initiative, a research study was conducted involving 628 multidisciplinary expert wound clinicians and researchers from 4 different groups: the interdisciplinary core advisory team; attendees of the Spring 2015 Symposium on Advanced Wound Care (SAWC); clinicians employed by a national network of specialty clinics focused on comprehensive wound care; and Association for the Advancement of Wound Care (AAWC) and Wound Healing Society (WHS) members who had not previously completed the survey. The online survey assessed 28 literature-based wound care endpoints for their relevance and importance to clinical practice and clinical research. Fifteen of the endpoints were evaluated for their relevance to improving quality of life. Twenty-two endpoints had content validity indexes (CVI) ≥ 0.75, and 15 were selected as meriting potential inclusion as additional endpoints for FDA approval of future wound care interventions. This study represents an important first step in identifying and validating new measurable wound care endpoints for clinical research and practice and for regulatory

  1. Use of cinacalcet in nephrolithiasis associated with normocalcemic or hypercalcemic primary hyperparathyroidism: results of a prospective randomized pilot study

    Directory of Open Access Journals (Sweden)

    Simone Brardi

    2015-03-01

    Full Text Available Objectives: To evaluate, by means of a prospective randomized study, the efficacy of cinacalcet in the forms of nephrolithiasis associated with primary hyperparathyroidism in both the hypercalcemic and normocalcemic variant. Materials and Methods: Ten patients suffering from active nephrolithiasis associated with primary hyperparathyroidism (4 hypercalcemics and 6 normocalcemics, equally divided between males and females, were randomly but not blindly addressed to treatment with potassium citrate and allopurinol, or to the same therapeutic regimen in combination with cinacalcet. The dosage of cinacalcet was optimized for each patient in order to obtain a reduction of parathyroid hormone (PTH within normal limits while enabling the maintenance of adequate calcemic values. All study participants were given the same diet based on a reduction in sodium intake, oxalate-rich foods and animal protein with standardized intake of calcium and an increase in hydration. After a follow up period of 10 months , cinacalcet was associated to standard therapy and diet in patients who were not taken it, conversely cinacalcet was withdrawn in the remaining patients who remained on standard therapeutic regimen and diet. Follow up was continued for a second period of observation of the same duration of the first. Results: At the end of the period of treatment with cinacalcet, for both variants of hyperparathyroidism, a statistically significant reduction in the overall number and in the diameter of renal stones was found. Conclusions: This prospective randomized study shows the effectiveness of cinacalcet used in combination with a diet with normalized calcium intake, in reducing the number and size of urinary stones in hypercalemic and normocalcemic forms of primary hyperparathyroidism.

  2. Willingness to pay for physician services at a primary contact in Ukraine: Results of a contingent valuation study

    Directory of Open Access Journals (Sweden)

    Danyliv, Andriy

    2011-05-01

    Full Text Available BACKGROUND. Reforming healthcare system in Ukraine would imply changing financial mechanisms and involving patients into copayment for physician services. Therefore, it is important to understand patients’ willingness to pay (WTP and its main drivers. This study aims to investigate patients’ willingness to pay for physician services at a primary contact, its levels and determinants.METHODS. Contingent valuation method was applied to a nationally representative sample of 303 adult respondents surveyed in 2009. Respondents stated their willingness to pay for a visit to four hypothetical physicians, whose profiles were designed in a way to estimate separate effects of physician’s specialization and joint improvement in three quality-related attributes of a service: the state of medical equipment, maintenance of the physician’s office, and reduction in waiting time. A random effect tobit regression was applied to model effect of these service characteristics and socio-demographic characteristics on WTP.RESULTS. The strongest predictors (insensitive to model specifications associated with higher WTP for physician services were quality improvements in the three characteristics of the physician’s profile, higher income, and presence of private insurance policy, while the one associated with reduced WTP was age over 70. Consultation with a medical specialist instead of a general practitioner was also associated with higher WTP, though the magnitude of effect was much lower than for the abovementioned factors.CONCLUSIONS. Ukrainians are willing to pay for physician services at a primary contact, but the highest WTP would be expected for services of improved clinical and social quality and access. There might be an intention in the society or some of its groups to avoid the gatekeeper general practitioner at a primary level and to refer directly to the medical specialist. Finally, if patient payments are introduced, special caution should be

  3. Double-Shell Tank Visual Inspection Changes Resulting from the Tank 241-AY-102 Primary Tank Leak

    International Nuclear Information System (INIS)

    Girardot, Crystal L.; Washenfelder, Dennis J.; Johnson, Jeremy M.; Engeman, Jason K.

    2013-01-01

    As part of the Double-Shell Tank (DST) Integrity Program, remote visual inspections are utilized to perform qualitative in-service inspections of the DSTs in order to provide a general overview of the condition of the tanks. During routine visual inspections of tank 241-AY-102 (AY-102) in August 2012, anomalies were identified on the annulus floor which resulted in further evaluations. In October 2012, Washington River Protection Solutions, LLC determined that the primary tank of AY-102 was leaking. Following identification of the tank AY-102 probable leak cause, evaluations considered the adequacy of the existing annulus inspection frequency with respect to the circumstances of the tank AY-102 1eak and the advancing age of the DST structures. The evaluations concluded that the interval between annulus inspections should be shortened for all DSTs, and each annulus inspection should cover > 95 percent of annulus floor area, and the portion of the primary tank (i.e., dome, sidewall, lower knuckle, and insulating refractory) that is visible from the annulus inspection risers. In March 2013, enhanced visual inspections were performed for the six oldest tanks: 241-AY-101, 241-AZ-101,241-AZ-102, 241-SY-101, 241-SY-102, and 241-SY-103, and no evidence of leakage from the primary tank were observed. Prior to October 2012, the approach for conducting visual examinations of DSTs was to perform a video examination of each tank's interior and annulus regions approximately every five years (not to exceed seven years between inspections). Also, the annulus inspection only covered about 42 percent of the annulus floor

  4. Gene expression profiling reveals multiple toxicity endpoints induced by hepatotoxicants

    Energy Technology Data Exchange (ETDEWEB)

    Huang Qihong; Jin Xidong; Gaillard, Elias T.; Knight, Brian L.; Pack, Franklin D.; Stoltz, James H.; Jayadev, Supriya; Blanchard, Kerry T

    2004-05-18

    Microarray technology continues to gain increased acceptance in the drug development process, particularly at the stage of toxicology and safety assessment. In the current study, microarrays were used to investigate gene expression changes associated with hepatotoxicity, the most commonly reported clinical liability with pharmaceutical agents. Acetaminophen, methotrexate, methapyrilene, furan and phenytoin were used as benchmark compounds capable of inducing specific but different types of hepatotoxicity. The goal of the work was to define gene expression profiles capable of distinguishing the different subtypes of hepatotoxicity. Sprague-Dawley rats were orally dosed with acetaminophen (single dose, 4500 mg/kg for 6, 24 and 72 h), methotrexate (1 mg/kg per day for 1, 7 and 14 days), methapyrilene (100 mg/kg per day for 3 and 7 days), furan (40 mg/kg per day for 1, 3, 7 and 14 days) or phenytoin (300 mg/kg per day for 14 days). Hepatic gene expression was assessed using toxicology-specific gene arrays containing 684 target genes or expressed sequence tags (ESTs). Principal component analysis (PCA) of gene expression data was able to provide a clear distinction of each compound, suggesting that gene expression data can be used to discern different hepatotoxic agents and toxicity endpoints. Gene expression data were applied to the multiplicity-adjusted permutation test and significantly changed genes were categorized and correlated to hepatotoxic endpoints. Repression of enzymes involved in lipid oxidation (acyl-CoA dehydrogenase, medium chain, enoyl CoA hydratase, very long-chain acyl-CoA synthetase) were associated with microvesicular lipidosis. Likewise, subsets of genes associated with hepatotocellular necrosis, inflammation, hepatitis, bile duct hyperplasia and fibrosis have been identified. The current study illustrates that expression profiling can be used to: (1) distinguish different hepatotoxic endpoints; (2) predict the development of toxic endpoints; and

  5. Pulmonary Endpoints in Duchenne Muscular Dystrophy. A Workshop Summary.

    Science.gov (United States)

    Finder, Jonathan; Mayer, Oscar Henry; Sheehan, Daniel; Sawnani, Hemant; Abresch, R Ted; Benditt, Joshua; Birnkrant, David J; Duong, Tina; Henricson, Erik; Kinnett, Kathi; McDonald, Craig M; Connolly, Anne M

    2017-08-15

    Development of novel therapeutics for treatment of Duchenne muscular dystrophy (DMD) has led to clinical trials that include pulmonary endpoints that allow assessment of respiratory muscle status, especially in nonambulatory subjects. Parent Project Muscular Dystrophy (PPMD) convened a workshop in Bethesda, Maryland, on April 14 and 15, 2016, to summarize published respiratory data in DMD and give guidance to clinical researchers assessing the effect of interventions on pulmonary outcomes in DMD.

  6. Adaptive endpoint detection of seismic signal based on auto-correlated function

    International Nuclear Information System (INIS)

    Fan Wanchun; Shi Ren

    2000-01-01

    There are certain shortcomings for the endpoint detection by time-waveform envelope and/or by checking the travel table (both labelled as the artificial detection method). Based on the analysis of the auto-correlation function, the notion of the distance between auto-correlation functions was quoted, and the characterizations of the noise and the signal with noise were discussed by using the distance. Then, the method of auto-adaptable endpoint detection of seismic signal based on auto-correlated similarity was summed up. The steps of implementation and determining of the thresholds were presented in detail. The experimental results that were compared with the methods based on artificial detecting show that this method has higher sensitivity even in a low SNR circumstance

  7. The primary results for the mixed carbon material used for high flux steady-state tokamak operation in China

    International Nuclear Information System (INIS)

    Guo, Q.G.; Li, J.G.; Zhai, G.T.; Liu, L.; Song, J.R.; Zhang, L.F.; He, Y.X.; Chen, J.L.

    2001-01-01

    Several types of carbon mixed materials have been developed in China to be used for high flux steady-state tokamak operation. Performance evaluation of these materials is necessary to determine their applicability as PFCs for high flux steady state. This paper describes the primary results of carbon mixed materials and the effects of dopants on properties are primarily discussed. Test results reveal that bulk boronized graphite has excellent physical and mechanical properties while their thermal conductivity is no more than 73 W/m K due to the formation of a uniform boron-carbon solid solution. In case of multi-element doped graphite, titanium dopant or a decreased boron content is favorable to enhance thermal conductivity. A kind of doped graphite has been developed with thermal conductivity as high as 278 W/m K by optimizing the compositions. Correlations among compositions, microstructure and properties of such doped graphite are discussed

  8. Overview of Biomarkers and Surrogate Endpoints in Drug Development

    Directory of Open Access Journals (Sweden)

    John A. Wagner

    2002-01-01

    Full Text Available There are numerous factors that recommend the use of biomarkers in drug development including the ability to provide a rational basis for selection of lead compounds, as an aid in determining or refining mechanism of action or pathophysiology, and the ability to work towards qualification and use of a biomarker as a surrogate endpoint. Examples of biomarkers come from many different means of clinical and laboratory measurement. Total cholesterol is an example of a clinically useful biomarker that was successfully qualified for use as a surrogate endpoint. Biomarkers require validation in most circumstances. Validation of biomarker assays is a necessary component to delivery of high-quality research data necessary for effective use of biomarkers. Qualification is necessary for use of a biomarker as a surrogate endpoint. Putative biomarkers are typically identified because of a relationship to known or hypothetical steps in a pathophysiologic cascade. Biomarker discovery can also be effected by expression profiling experiment using a variety of array technologies and related methods. For example, expression profiling experiments enabled the discovery of adipocyte related complement protein of 30 kD (Acrp30 or adiponectin as a biomarker for in vivo activation of peroxisome proliferator-activated receptors (PPAR γ activity.

  9. Congenital Adrenal Hyperplasia: Classification of Studies Employing Psychological Endpoints

    Directory of Open Access Journals (Sweden)

    Sandberg DavidE

    2010-08-01

    Full Text Available Psychological outcomes in persons with congenital adrenal hyperplasia (CAH have received substantial attention. The objectives of this paper were to (1 catalog psychological endpoints assessed in CAH outcome studies and (2 classify the conceptual/theoretical model shaping the research design and interpretation of CAH-related psychological effects. A total of 98 original research studies, published between 1955 and 2009, were categorized based on psychological endpoints examined as well as the research design and conceptual model guiding analysis and interpretation of data. The majority of studies (68% investigated endpoints related to psychosexual differentiation. The preponderance of studies (76% examined a direct relationship (i.e., inferring causality between prenatal androgen exposure and psychological outcomes. Findings are discussed in relation to the observed imbalance between theoretical interest in the role of prenatal androgens in shaping psychosexual differentiation and a broader conceptual model that examines the role of other potential factors in mediating or moderating the influence of CAH pathophysiology on psychological outcomes in both affected females and males. The latter approach offers to identify factors amenable to clinical intervention that enhance both health and quality of life outcomes in CAH as well as other disorders of sex development.

  10. Effectiveness of Problem-Solving Therapy for Older, Primary Care Patients with Depression: Results from the IMPACT Project

    Science.gov (United States)

    Arean, Patricia; Hegel, Mark; Vannoy, Steven; Fan, Ming-Yu; Unuzter, Jurgen

    2008-01-01

    Purpose: We compared a primary-care-based psychotherapy, that is, problem-solving therapy for primary care (PST-PC), to community-based psychotherapy in treating late-life major depression and dysthymia. Design and Methods: The data here are from the IMPACT study, which compared collaborative care within a primary care clinic to care as usual in…

  11. Depression, anxiety, and somatoform disorders: vague or distinct categories in primary care? Results from a large cross-sectional study.

    Science.gov (United States)

    Hanel, Gertraud; Henningsen, Peter; Herzog, Wolfgang; Sauer, Nina; Schaefert, Rainer; Szecsenyi, Joachim; Löwe, Bernd

    2009-09-01

    Depression, anxiety, and somatization are the most frequently observed mental disorders in primary health care. Our main objective was to draw on the often neglected general practitioners' (GPs) perspective to investigate what characterizes these three common mental diagnoses with regard to creating more suitable categories in the DSM-V and ICD-11. We collected independent data from 1751 primary care patients (participation rate=77%) and their 32 treating GPs in Germany. Patients filled out validated patient self-report measures for depression (PHQ-9), somatic symptom severity (PHQ-15), and illness anxiety (Whiteley-7), and questions regarding coping and attribution of illness. GPs' clinical diagnoses and associated features were assessed. Patients diagnosed by their GPs with depression, anxiety, and/or somatoform disorders were significantly older, less educated, and more often female than the reference group not diagnosed with a mental disorder. They had visited the GP more often, had a longer duration of symptoms, and were more often under social or financial stress. Among the mental disorders diagnosed by the GPs, depression (OR=4.4; 95% CI=2.6 to 7.5) and comorbidity of somatoform, depressive, and anxiety disorders (OR=9.5; 95% CI=4.6 to 19.4) were associated with the largest degrees of impairment compared to the reference group. Patients diagnosed as having a somatoform/functional disorder only had mildly elevated impairment on all dimensions (OR=2.0; 95% CI=1.4 to 2.7). Similar results were found for the physicians' attribution of psychosocial factors for cause and maintenance of the disease, difficult patient-doctor relationship, and self-assessed mental disorder. In order to make the DSM-V and ICD-11 more suitable for primary care, we propose providing appropriate diagnostic categories for (1) the many mild forms of mental syndromes typically seen in primary care; and (2) the severe forms of comorbidity between somatoform, depressive, and/or anxiety

  12. Quantitative 4D Transcatheter Intraarterial Perfusion MR Imaging as a Method to Standardize Angiographic Chemoembolization Endpoints

    Science.gov (United States)

    Jin, Brian; Wang, Dingxin; Lewandowski, Robert J.; Ryu, Robert K.; Sato, Kent T.; Larson, Andrew C.; Salem, Riad; Omary, Reed A.

    2011-01-01

    PURPOSE We aimed to test the hypothesis that subjective angiographic endpoints during transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) exhibit consistency and correlate with objective intraprocedural reductions in tumor perfusion as determined by quantitative four dimensional (4D) transcatheter intraarterial perfusion (TRIP) magnetic resonance (MR) imaging. MATERIALS AND METHODS This prospective study was approved by the institutional review board. Eighteen consecutive patients underwent TACE in a combined MR/interventional radiology (MR-IR) suite. Three board-certified interventional radiologists independently graded the angiographic endpoint of each procedure based on a previously described subjective angiographic chemoembolization endpoint (SACE) scale. A consensus SACE rating was established for each patient. Patients underwent quantitative 4D TRIP-MR imaging immediately before and after TACE, from which mean whole tumor perfusion (Fρ) was calculated. Consistency of SACE ratings between observers was evaluated using the intraclass correlation coefficient (ICC). The relationship between SACE ratings and intraprocedural TRIP-MR imaging perfusion changes was evaluated using Spearman’s rank correlation coefficient. RESULTS The SACE rating scale demonstrated very good consistency among all observers (ICC = 0.80). The consensus SACE rating was significantly correlated with both absolute (r = 0.54, P = 0.022) and percent (r = 0.85, P SACE rating scale demonstrates very good consistency between raters, and significantly correlates with objectively measured intraprocedural perfusion reductions during TACE. These results support the use of the SACE scale as a standardized alternative method to quantitative 4D TRIP-MR imaging to classify patients based on embolic endpoints of TACE. PMID:22021520

  13. Is primary care a neglected piece of the jigsaw in ensuring optimal stroke care? Results of a national study.

    LENUS (Irish Health Repository)

    Whitford, David L

    2009-01-01

    BACKGROUND: Stroke is a major cause of mortality and morbidity with potential for improved care and prevention through general practice. A national survey was undertaken to determine current resources and needs for optimal stroke prevention and care. METHODS: Postal survey of random sample of general practitioners undertaken (N = 204; 46% response). Topics included practice organisation, primary prevention, acute management, secondary prevention, long-term care and rehabilitation. RESULTS: Service organisation for both primary and secondary prevention was poor. Home management of acute stroke patients was used at some stage by 50% of responders, accounting for 7.3% of all stroke patients. Being in a structured cardiovascular management scheme, a training practice, a larger practice, or a practice employing a practice nurse were associated with structures and processes likely to support stroke prevention and care. CONCLUSION: General practices were not fulfilling their potential to provide stroke prevention and long-term management. Systems of structured stroke management in general practice are essential to comprehensive national programmes of stroke care.

  14. Is primary care a neglected piece of the jigsaw in ensuring optimal stroke care? Results of a national study

    Directory of Open Access Journals (Sweden)

    O'Sullivan Bernadette

    2009-04-01

    Full Text Available Abstract Background Stroke is a major cause of mortality and morbidity with potential for improved care and prevention through general practice. A national survey was undertaken to determine current resources and needs for optimal stroke prevention and care. Methods Postal survey of random sample of general practitioners undertaken (N = 204; 46% response. Topics included practice organisation, primary prevention, acute management, secondary prevention, long-term care and rehabilitation. Results Service organisation for both primary and secondary prevention was poor. Home management of acute stroke patients was used at some stage by 50% of responders, accounting for 7.3% of all stroke patients. Being in a structured cardiovascular management scheme, a training practice, a larger practice, or a practice employing a practice nurse were associated with structures and processes likely to support stroke prevention and care. Conclusion General practices were not fulfilling their potential to provide stroke prevention and long-term management. Systems of structured stroke management in general practice are essential to comprehensive national programmes of stroke care.

  15. Medication documentation in a primary care network serving North Carolina medicaid patients: results of a cross-sectional chart review

    Directory of Open Access Journals (Sweden)

    Olson Matthew D

    2012-08-01

    Full Text Available Abstract Background Medical records that do not accurately reflect the patient’s current medication list are an open invitation to errors and may compromise patient safety. Methods This cross-sectional study compares primary care provider (PCP medication lists and pharmacy claims for 100 patients seen in 8 primary care practices and examines the association of congruence with demographic, clinical, and practice characteristics. Medication list congruence was measured as agreement of pharmacy claims with the entire PCP chart, including current medication list, visit notes, and correspondence sections. Results Congruence between pharmacy claims and the PCP chart was 65%. Congruence was associated with large chronic disease burden, frequent PCP visits, group practice, and patient age ≥45 years. Conclusion Agreement of medication lists between the PCP chart and pharmacy records is low. Medication documentation was more accurate among patients who have more chronic conditions, those who have frequent PCP visits, those whose practice has multiple providers, and those at least 45 years of age. Improved congruence among patients with multiple chronic conditions and in group practices may reflect more frequent visits and reviews by providers.

  16. SELECTIVE AND NONSELECTIVE β-BLOCKERS IN PRIMARY OPEN ANGLE GLAUCOMA THERAPY – RESULTS OF COLOR DOPPLER SONOGRAPHY

    Directory of Open Access Journals (Sweden)

    Vukoslava Maričić-Došen

    2002-12-01

    Full Text Available Background. Primary open angle glaucoma (POAG is a syndrome of progressive optic neuropathy characterized by optic nerve head excavation and visual field defects. Poor correlation between IOP and progression of glaucoma disease sets vascular mechanism in the centre of attention. By Color Doppler sonography, quantification of blood flow changes in vessels, which supply optic nerve head, is possible. We wanted to find out whether there are changes in the circulation of central retinal artery and posterior ciliary arteries in patients with primary open angle glaucoma treated with selective or nonselective β -blockers.Methods. 44 patients (88 eyes were divided into two groups: group 1: 22 patients (44 eyes treated with selective β -blockers (Betaxolol 0.5% and group 2: 22 patients (44 eyes treated with nonselective β -blockers (Timolol 0.5%. Vascular indices (RI, PI were measured in the central retinal artery and posterior ciliary arteries.Results. We found decreased blood flow and increased vascular indices in both groups of patients, statistically significant difference between group 1 and group 2: blood flow velocity was higher and vascular indices were lower in group 1 (Betaxolol 0.5% compared to group 2 (Timolol 0..5%.Conclusions. Selective β -blockers (calcium channel blockers act more vasoactively and neuroprotectively comparing to nonselective β -blockers.

  17. After-visit summaries in primary care: mixed methods results from a literature review and stakeholder interviews.

    Science.gov (United States)

    Lyles, Courtney R; Gupta, Reena; Tieu, Lina; Fernandez, Alicia

    2018-05-28

    After-visit summary (AVS) documents presenting key information from each medical encounter have become standard in the USA due to federal health care reform. Little is known about how they are used or whether they improve patient care. First, we completed a literature review and described the totality of the literature on AVS by article type and major outcome measures. Next, we used reputational sampling from large-scale US studies on primary care to identify and interview nine stakeholders on their perceptions of AVS across high-performing primary care practices. Interviews were transcribed and coded for AVS use in practice, perceptions of the best/worst features and recommendations for improving AVS utility in routine care. The literature review resulted in 17 studies; patients reported higher perceived value of AVS compared with providers, despite poor recall of specific AVS content and varied post-visit use. In key informant interviews, key informants expressed enthusiasm for the potential of using AVS to reinforce key information with patients, especially if AVS were customizable. Despite this potential, key informants found that AVS included incorrect information and did not feel that patients or their practices were using AVS to enhance care. There is a gap between the potential of AVS and how providers and patients are using it in routine care. Suggestions for improved use of AVS include increasing customization, establishing care team responsibilities and workflows and ensuring patients with communication barriers have dedicated support to review AVS during visits.

  18. Uterine artery embolisation versus hysterectomy for leiomyomas: primary and 2-year follow-up results of a randomised prospective clinical trial

    International Nuclear Information System (INIS)

    Ruuskanen, Anu; Hippelaeinen, Maritta; Sipola, Petri; Manninen, Hannu

    2010-01-01

    To compare uterine artery embolisation (UAE) and hysterectomy for the treatment of leiomyomas at 2-year follow-up in a prospective, randomised, single-centre study. Fifty-seven symptomatic patients were randomised to UAE (n = 27) or hysterectomy (n = 30). Complications, recovery, reinterventions and satisfaction with treatment were recorded. Primary endpoint was improvement of symptoms. Analyses were performed by intent-to-treat and per protocol. Two hysterectomy patients (7%) developed major complications. Hospital discharge occurred earlier after UAE than after hysterectomy (p < 0.001). Length of sick leave was longer after hysterectomy than after UAE (p < 0.001). Twenty-two (82%) UAE patients and 28 (93%) hysterectomy patients reported overall relief of symptoms (p = 0.173). In 12/18 (67%) UAE patients menorrhagia was completely resolved or reduced. Improvement of pressure symptoms was reported significantly more by UAE patients than by hysterectomy patients (19/20 [95%] versus 18/26 [69%], respectively; p = 0.029). Five (19%) UAE patients underwent additional interventions due to worsening symptoms. Twenty-four (89%) UAE patients and 29 (97%) hysterectomy patients would have chosen treatment again (p = 0.336). UAE gave relief of symptoms (apart from menorrhagia) comparable to hysterectomy with less severe complications, but with an increased rate of secondary interventions. UAE may be the preferable treatment especially for patients with pressure symptoms. (orig.)

  19. Is primary prevention of childhood obesity by education at 13-month immunisations feasible and acceptable? Results from a general practice based pilot study.

    LENUS (Irish Health Repository)

    Doorley, E

    2015-01-01

    Abstract Prevalence of childhood overweight and obesity remains high in Ireland. In this study an intervention conducted within primary care was evaluated. This involved a structured discussion with parents at the 13 month immunisations with their general practitioner (GP), including measuring weight of the toddler and parental education regarding healthy nutrition and physical activity for their toddler. There was a telephone follow-up interview with parents three months later assessing change in toddler diet\\/lifestyle. Endpoints assessed included parents\\' reports of specific lifestyle parameters with regard to the toddler and parental assessment of the usefulness of the intervention. 39 toddlers were studied. Most lifestyle parameters had improved at follow up. Reported fruit and vegetable intake of more than 4 portions per day increased from 20.5% of toddlers at baseline 28.6% at follow up. The number of toddlers abstaining from unhealthy snacks increased from 15.4% to 21.4%. Television watching of more than 2 hours daily decreased from 12.8% to 0%. Supervised exercise of more than thirty minutes per day increased from 69.2% to 89.3%. The majority of parents reported at follow up that they found the intervention acceptable (100%, n = 28) and useful (79%, n = 22).

  20. Uterine artery embolisation versus hysterectomy for leiomyomas: primary and 2-year follow-up results of a randomised prospective clinical trial

    Energy Technology Data Exchange (ETDEWEB)

    Ruuskanen, Anu [Kuopio University Hospital, Department of Clinical Radiology, P.O. Box 1777, Kuopio (Finland); Hippelaeinen, Maritta [Kuopio University Hospital, Department of Obstetrics and Gynaecology, P.O. Box 1777, Kuopio (Finland); Sipola, Petri; Manninen, Hannu [Kuopio University Hospital, Department of Clinical Radiology, P.O. Box 1777, Kuopio (Finland); University of Eastern Finland, Faculty of Health Sciences, Institute of Clinical Medicine, P.O. Box 1627, Kuopio (Finland)

    2010-10-15

    To compare uterine artery embolisation (UAE) and hysterectomy for the treatment of leiomyomas at 2-year follow-up in a prospective, randomised, single-centre study. Fifty-seven symptomatic patients were randomised to UAE (n = 27) or hysterectomy (n = 30). Complications, recovery, reinterventions and satisfaction with treatment were recorded. Primary endpoint was improvement of symptoms. Analyses were performed by intent-to-treat and per protocol. Two hysterectomy patients (7%) developed major complications. Hospital discharge occurred earlier after UAE than after hysterectomy (p < 0.001). Length of sick leave was longer after hysterectomy than after UAE (p < 0.001). Twenty-two (82%) UAE patients and 28 (93%) hysterectomy patients reported overall relief of symptoms (p = 0.173). In 12/18 (67%) UAE patients menorrhagia was completely resolved or reduced. Improvement of pressure symptoms was reported significantly more by UAE patients than by hysterectomy patients (19/20 [95%] versus 18/26 [69%], respectively; p = 0.029). Five (19%) UAE patients underwent additional interventions due to worsening symptoms. Twenty-four (89%) UAE patients and 29 (97%) hysterectomy patients would have chosen treatment again (p = 0.336). UAE gave relief of symptoms (apart from menorrhagia) comparable to hysterectomy with less severe complications, but with an increased rate of secondary interventions. UAE may be the preferable treatment especially for patients with pressure symptoms. (orig.)

  1. Muscle Synergies Heavily Influence the Neural Control of Arm Endpoint Stiffness and Energy Consumption.

    Science.gov (United States)

    Inouye, Joshua M; Valero-Cuevas, Francisco J

    2016-02-01

    Much debate has arisen from research on muscle synergies with respect to both limb impedance control and energy consumption. Studies of limb impedance control in the context of reaching movements and postural tasks have produced divergent findings, and this study explores whether the use of synergies by the central nervous system (CNS) can resolve these findings and also provide insights on mechanisms of energy consumption. In this study, we phrase these debates at the conceptual level of interactions between neural degrees of freedom and tasks constraints. This allows us to examine the ability of experimentally-observed synergies--correlated muscle activations--to control both energy consumption and the stiffness component of limb endpoint impedance. In our nominal 6-muscle planar arm model, muscle synergies and the desired size, shape, and orientation of endpoint stiffness ellipses, are expressed as linear constraints that define the set of feasible muscle activation patterns. Quadratic programming allows us to predict whether and how energy consumption can be minimized throughout the workspace of the limb given those linear constraints. We show that the presence of synergies drastically decreases the ability of the CNS to vary the properties of the endpoint stiffness and can even preclude the ability to minimize energy. Furthermore, the capacity to minimize energy consumption--when available--can be greatly affected by arm posture. Our computational approach helps reconcile divergent findings and conclusions about task-specific regulation of endpoint stiffness and energy consumption in the context of synergies. But more generally, these results provide further evidence that the benefits and disadvantages of muscle synergies go hand-in-hand with the structure of feasible muscle activation patterns afforded by the mechanics of the limb and task constraints. These insights will help design experiments to elucidate the interplay between synergies and the mechanisms

  2. Energy metabolism and biotransformation as endpoints to pre-screen hepatotoxicity using a liver spheroid model

    International Nuclear Information System (INIS)

    Xu Jinsheng; Purcell, Wendy M.

    2006-01-01

    The current study investigated liver spheroid culture as an in vitro model to evaluate the endpoints relevant to the status of energy metabolism and biotransformation after exposure to test toxicants. Mature rat liver spheroids were exposed to diclofenac, galactosamine, isoniazid, paracetamol, m-dinitrobenzene (m-DNB) and 3-nitroaniline (3-NA) for 24 h. Pyruvate uptake, galactose biotransformation, lactate release and glucose secretion were evaluated after exposure. The results showed that pyruvate uptake and lactate release by mature liver spheroids in culture were maintained at a relatively stable level. These endpoints, together with glucose secretion and galactose biotransformation, were related to and could reflect the status of energy metabolism and biotransformation in hepatocytes. After exposure, all of the test agents significantly reduced glucose secretion, which was shown to be the most sensitive endpoint of those evaluated. Diclofenac, isoniazid, paracetamol and galactosamine reduced lactate release (P < 0.01), but m-DNB increased lactate release (P < 0.01). Diclofenac, isoniazid and paracetamol also reduced pyruvate uptake (P < 0.01), while galactosamine had little discernible effect. Diclofenac, galactosamine, paracetamol and m-DNB also reduced galactose biotransformation (P < 0.01), by contrast, isoniazid did not. The metabolite of m-DNB, 3-NA, which served as a negative control, did not cause significant changes in lactate release, pyruvate uptake or galactose biotransformation. It is concluded that pyruvate uptake, galactose biotransformation, lactate release and glucose secretion can be used as endpoints for evaluating the status of energy metabolism and biotransformation after exposure to test agents using the liver spheroid model to pre-screen hepatotoxicity

  3. Preferences for Depression Treatment Including Internet-Based Interventions: Results From a Large Sample of Primary Care Patients

    Directory of Open Access Journals (Sweden)

    Marie Dorow

    2018-05-01

    Full Text Available Background: To date, little is known about treatment preferences for depression concerning new media. This study aims to (1 investigate treatment preferences for depression including internet-based interventions and (2 examine subgroup differences concerning age, gender and severity of depression as well as patient-related factors associated with treatment preferences.Methods: Data were derived from the baseline assessment of the @ktiv-trial. Depression treatment preferences were assessed from n = 641 primary care patients with mild to moderate depression regarding the following treatments: medication, psychotherapy, combined treatment, alternative treatment, talking to friends and family, exercise, self-help literature, and internet-based interventions. Depression severity was specified by GPs according to ICD-10 criteria. Ordinal logistic regression models were conducted to identify associated factors of treatment preferences.Results: Patients had a mean age of 43.9 years (SD = 13.8 and more than two thirds (68.6% were female. About 43% of patients had mild depression while 57% were diagnosed with moderate depression. The majority of patients reported strong preferences for psychotherapy, talking to friends and family, and exercise. About one in five patients was very likely to consider internet-based interventions in case of depression. Younger patients expressed significantly stronger treatment preferences for psychotherapy and internet-based interventions than older patients. The most salient factors associated with treatment preferences were the patients' education and perceived self-efficacy.Conclusions: Patients with depression report individually different treatment preferences.Our results underline the importance of shared decision-making within primary care. Future studies should investigate treatment preferences for different types of internet-based interventions.

  4. The impact of secure messaging on workflow in primary care: Results of a multiple-case, multiple-method study.

    Science.gov (United States)

    Hoonakker, Peter L T; Carayon, Pascale; Cartmill, Randi S

    2017-04-01

    Secure messaging is a relatively new addition to health information technology (IT). Several studies have examined the impact of secure messaging on (clinical) outcomes but very few studies have examined the impact on workflow in primary care clinics. In this study we examined the impact of secure messaging on workflow of clinicians, staff and patients. We used a multiple case study design with multiple data collections methods (observation, interviews and survey). Results show that secure messaging has the potential to improve communication and information flow and the organization of work in primary care clinics, partly due to the possibility of asynchronous communication. However, secure messaging can also have a negative effect on communication and increase workload, especially if patients send messages that are not appropriate for the secure messaging medium (for example, messages that are too long, complex, ambiguous, or inappropriate). Results show that clinicians are ambivalent about secure messaging. Secure messaging can add to their workload, especially if there is high message volume, and currently they are not compensated for these activities. Staff is -especially compared to clinicians- relatively positive about secure messaging and patients are overall very satisfied with secure messaging. Finally, clinicians, staff and patients think that secure messaging can have a positive effect on quality of care and patient safety. Secure messaging is a tool that has the potential to improve communication and information flow. However, the potential of secure messaging to improve workflow is dependent on the way it is implemented and used. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. Health locus of control as a psychological factor in improving treatment results in adolescents with primary hypertension and diabetes

    Directory of Open Access Journals (Sweden)

    Marta Anna Biernacka

    2016-10-01

    Full Text Available Background The belief that an individual can influence and control the course of events is a factor which enables a person to overcome difficulties. Some studies, however, have questioned the universality of this statement. This study aims to investigate and explore the relationship between the self-health locus of control and the effectiveness of cooperation in the treatment process in adolescents with chronic diseases. Participants and procedure One hundred and sixty-four adolescent patients suffering from chronic diseases (61 girls and 103 boys ranging from 11 to 17 years old participated in the study. Eighty-seven had primary hypertension and 77 had type 1 diabetes. To investigate their sense of health control we used the Health Locus of Control Scale (HLC. Cooperation in the treatment process was assessed using a 4-item scale completed by a doctor. Results Better results in the treatment were positively correlated with a better internal health locus of control. A negative correlation between the chance health locus of control and results in the treatment was found. Differences in the health locus of control proved to be dependent on gender, age and different clinical groups. Conclusions Health locus of control in patients with chronic diseases seems to be a crucial factor in determining the results of the treatment process in such patients.

  6. Primary surgery results in no survival benefit compared to primary radiation for oropharyngeal cancer patients stratified by high-risk human papilloma virus status.

    Science.gov (United States)

    Lybak, Stein; Ljøkjel, Borghild; Haave, Hilde; Karlsdottir, Àsa; Vintermyr, Olav K; Aarstad, Hans Jørgen

    2017-01-01

    We changed the primary oropharynx squamous cell carcinoma (OPSCC) treatment recommendation from primary radiation therapy (RT) to tumor surgery and neck dissection, followed by RT around the year 2000 with apparently improved survival. However, high-risk human papilloma virus (hr-HPV)-16-caused OPSCCs have increased during this period. Furthermore, hr-HPV+ OPSCC carry a better prognosis than hr-HPV-negative patients. We have, therefore, evaluated the 5-year survival in the period from 1992 to 1999 versus 2000 to 2008 stratified by hr-HPV tumor infection status. Ninety-six OPSCC patients were treated from 1992 to 1999 compared with 136 patients from 2000 to 2008. The 5-year disease-specific survival (DDS) and overall survival (OS) were recorded, while the health-related quality of life (HRQoL) scores were obtained from some of the cured patients. Thirty-eight (40 %) in the first period and 86 OPSCCs (63 %) in the second period were hr-HPV+. In the first period, 16 versus 62 patients in the last period were treated by neck dissection, primary tumor surgery, and RT. DSS among all the hr-HPV-negative patients in the first period was 51 versus 55 % in the second period, and the corresponding OS was 33 versus 31 %, respectively. The DSS among all the hr-HPV+ patients was 78 % in the first period versus 77 % in the second period, while the OS was 71 versus 69 %, respectively. The HRQoL scores among successfully treated patients were worse following surgery, plus RT than RT only. The hr-HPV-adjusted 5-year survival in OPSCC patients was similar between the two time periods. A decreased HRQoL was associated with surgical therapy, which indicates that hr-HPV+ OPSCC patients may be treated by primary RT followed by major surgery only if RT treatment fails.

  7. Sodium chloride as a reference substance for the three growth endpoints used in the Lemna minor L. (1753 test

    Directory of Open Access Journals (Sweden)

    Aline Andrade Godoy

    2017-01-01

    Full Text Available Lemna sp. growth inhibition test standardized protocols suggest the use of compounds such as 3,5-dichlorophenol as reference substances for checking the test organism’s sensitivity routinely. However, this and other recommended chemicals present risks to human health and to the environment. Sodium chloride (NaCl appears as a less toxic alternative reference substance which has been successfully used in routine ecotoxicological tests. However, the evaluation of this compound in multiple growth endpoints used in the L. minor test, which is required for recommending it as a reference substance for this test organism, has not yet been reported. In the present study, NaCl was tested with L. minor for the growth endpoints frond number, total frond area and fresh weight. Results showed acceptable sensitivity and reproducibility (coefficient of variance < 15.0% for all three of the measured endpoints. Statistically significant differences were observed between the EC50 values calculated based on the three endpoints (p < 0.05. Total frond area was the most sensitive one, with average EC50 value of 2742.80 ± 245.7 mg L-1. It was anticipated that NaCl can be a suitable alternative reference substance and that total frond area should be the endpoint of choice for sensitivity toxicity tests using NaCl.

  8. Analysis of cosmetic results following primary radiation therapy for stages I and II carcinoma of the breast

    International Nuclear Information System (INIS)

    Harris, J.R.; Levene, M.B.; Svensson, G.; Hellman, S.

    1979-01-01

    In 31 cases of Stages I or II carcinoma of the breast treated by primary radiation therapy, the cosmetic results were analyzed with regard to the details of treatment. Three principal treatment factors were identified which influenced the cosmetic outcome: (1) the extent and location of the biopsy procedure; (2) the time/dose factors of the radiation therapy; and (3) the technique of the radiation therapy. Cosmetic results were lessened when the biopsy procedure included a wide resection of adjacent breast tissue or when the biopsy scar was obvious. Increasing doses of external beam radiation were associated with greater degrees of retraction and fibrosis of the treated breast. All 6 patients who received 6000 rad by external beam had significant retraction, and fibrosis while patients who received 5000 rad rarely showed significant changes. Local boost doses by interstitial implantation did not diminsh the cosmetic outcome. All patients were treated using supervoltage equipment without bolus and skin changes secondary to treatment were infrequent. Seventeen patients developed localized areas of fibrosis and skin changes at the matchline between adjacent radiation fields. Recommendations are made for improved cosmetic results based on these findings

  9. Gene disruption of Plasmodium falciparum p52 results in attenuation of malaria liver stage development in cultured primary human hepatocytes.

    Directory of Open Access Journals (Sweden)

    Ben C L van Schaijk

    Full Text Available Difficulties with inducing sterile and long lasting protective immunity against malaria with subunit vaccines has renewed interest in vaccinations with attenuated Plasmodium parasites. Immunizations with sporozoites that are attenuated by radiation (RAS can induce strong protective immunity both in humans and rodent models of malaria. Recently, in rodent parasites it has been shown that through the deletion of a single gene, sporozoites can also become attenuated in liver stage development and, importantly, immunization with these sporozoites results in immune responses identical to RAS. The promise of vaccination using these genetically attenuated sporozoites (GAS depends on translating the results in rodent malaria models to human malaria. In this study, we perform the first essential step in this transition by disrupting, p52, in P. falciparum an ortholog of the rodent parasite gene, p36p, which we had previously shown can confer long lasting protective immunity in mice. These P. falciparum P52 deficient sporozoites demonstrate gliding motility, cell traversal and an invasion rate into primary human hepatocytes in vitro that is comparable to wild type sporozoites. However, inside the host hepatocyte development is arrested very soon after invasion. This study reveals, for the first time, that disrupting the equivalent gene in both P. falciparum and rodent malaria Plasmodium species generates parasites that become similarly arrested during liver stage development and these results pave the way for further development of GAS for human use.

  10. Lack of control of hypertension in primary cardiovascular disease prevention in Europe: Results from the EURIKA study.

    Science.gov (United States)

    Borghi, Claudio; Tubach, Florence; De Backer, Guy; Dallongeville, Jean; Guallar, Eliseo; Medina, Jesús; Perk, Joep; Roy, Carine; Banegas, José R; Rodriguez-Artalejo, Fernando; Halcox, Julian P

    2016-09-01

    The prevalence of and factors associated with uncontrolled hypertension and apparent resistant hypertension were assessed in the European Study on Cardiovascular Risk Prevention and Management in Usual Daily Practice (EURIKA; NCT00882336). EURIKA was a cross-sectional observational study including patients being treated for the primary prevention of cardiovascular disease in 12 European countries. Patients were assessed if they were being treated for hypertension (N=5220). Blood pressure control was defined according to European guidelines, with sensitivity analysis taking account of patients' age and diabetes status. Associated factors were assessed using multivariate analysis. In the primary analysis, a total of 2691 patients (51.6%) had uncontrolled hypertension. Factors significantly associated with an increased risk of having uncontrolled hypertension included female sex (odds ratio [OR]: 2.29; 95% confidence interval [CI]: 1.93-2.73), body mass index (BMI; OR per kg/m(2): 1.03; 95% CI: 1.01-1.04), and geographic location. A total of 749 patients (14.3%) had apparent resistant hypertension. Factors significantly associated with an increased risk of having apparent resistant hypertension included BMI (OR per kg/m(2): 1.06; 95% CI: 1.04-1.08), diabetes (OR: 1.28; 95% CI: 1.06-1.53), use of statins (OR: 1.36; 95% CI: 1.15-1.62), serum uric acid levels (OR: 1.16; 95% CI: 1.09-1.23), and geographic location. Similar results were seen in sensitivity analyses. Over 50% of patients treated for hypertension continued to have uncontrolled blood pressure and 14.3% had apparent resistant hypertension. Positive associations were seen with other cardiovascular risk factors. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  11. BOP2: Bayesian optimal design for phase II clinical trials with simple and complex endpoints.

    Science.gov (United States)

    Zhou, Heng; Lee, J Jack; Yuan, Ying

    2017-09-20

    We propose a flexible Bayesian optimal phase II (BOP2) design that is capable of handling simple (e.g., binary) and complicated (e.g., ordinal, nested, and co-primary) endpoints under a unified framework. We use a Dirichlet-multinomial model to accommodate different types of endpoints. At each interim, the go/no-go decision is made by evaluating a set of posterior probabilities of the events of interest, which is optimized to maximize power or minimize the number of patients under the null hypothesis. Unlike other existing Bayesian designs, the BOP2 design explicitly controls the type I error rate, thereby bridging the gap between Bayesian designs and frequentist designs. In addition, the stopping boundary of the BOP2 design can be enumerated prior to the onset of the trial. These features make the BOP2 design accessible to a wide range of users and regulatory agencies and particularly easy to implement in practice. Simulation studies show that the BOP2 design has favorable operating characteristics with higher power and lower risk of incorrectly terminating the trial than some existing Bayesian phase II designs. The software to implement the BOP2 design is freely available at www.trialdesign.org. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  12. Attempt to Determine the Prevalence of Two Inborn Errors of Primary Bile Acid Synthesis : Results of a European Survey

    NARCIS (Netherlands)

    Jahnel, Jörg; Zöhrer, Evelyn; Fischler, Björn; D'Antiga, Lorenzo; Debray, Dominique; Dezsofi, Antal; Haas, Dorothea; Hadzic, Nedim; Jacquemin, Emmanuel; Lamireau, Thierry; Maggiore, Giuseppe; McKiernan, Pat J; Calvo, Pier Luigi; Verkade, Henkjan J; Hierro, Loreto; McLin, Valerie; Baumann, Ulrich; Gonzales, Emmanuel

    2017-01-01

    Objective: Inborn errors of primary bile acid (BA) synthesis are genetic cholestatic disorders leading to accumulation of atypical BA with deficiency of normal BA. Unless treated with primary BA, chronic liver disease usually progresses to cirrhosis and liver failure before adulthood. We sought to

  13. Co- and multimorbidity patterns in primary care based on episodes of care: results from the German CONTENT project.

    NARCIS (Netherlands)

    Laux, G.; Kuehlein, T.; Rosemann, T.J.; Szecsenyi, J.

    2008-01-01

    BACKGROUND: Due to technological progress and improvements in medical care and health policy the average age of patients in primary care is continuously growing. In equal measure, an increasing proportion of mostly elderly primary care patients presents with multiple coexisting medical conditions.

  14. Surgical results of trabeculectomy and Ahmed valve implantation following a previous failed trabeculectomy in primary congenital glaucoma patients.

    Science.gov (United States)

    Lee, Naeun; Ma, Kyoung Tak; Bae, Hyoung Won; Hong, Samin; Seong, Gong Je; Hong, Young Jae; Kim, Chan Yun

    2015-04-01

    To compare the surgical results of trabeculectomy and Ahmed glaucoma valve implantation after a previous failed trabeculectomy. A retrospective comparative case series review was performed on 31 eye surgeries in 20 patients with primary congenital glaucoma who underwent trabeculectomy or Ahmed glaucoma valve implantation after a previous failed trabeculectomy with mitomycin C. The preoperative mean intraocular pressure was 25.5 mmHg in the trabeculectomy group and 26.9 mmHg in the Ahmed glaucoma valve implantation group (p = 0.73). The 48-month postoperative mean intraocular pressure was 19.6 mmHg in the trabeculectomy group and 20.2 mmHg in the Ahmed glaucoma valve implantation group (p = 0.95). The 12-month trabeculectomy success rate was 69%, compared with 64% for Ahmed glaucoma valve implantation, and the 48-month success rates were 42% and 36% for trabeculectomy and valve implantation, respectively. The success rates following the entire follow-up period were not significantly different between the two groups (p > 0.05 by log rank test). Postoperative complications occurred in 25% of the trabeculectomy-operated eyes and 9% of the Ahmed-implanted eyes (p = 0.38). There was no significant difference in surgical outcome between the trabeculectomy and Ahmed glaucoma valve implantation groups, neither of which had favorable results. However, the trabeculectomy group demonstrated a higher prevalence of adverse complications such as post-operative endophthalmitis.

  15. Radiometric titration of officinal radiopharmaceuticals using radioactive kryptonates as end-point indicators. I. Salicylic, acetylosalicylic, benzoic acids

    Energy Technology Data Exchange (ETDEWEB)

    Toelgyessy, J; Dillinger, P [Slovenska Vysoka Skola Technicka, Bratislava (Czechoslovakia). Chemickotechnologicka Fakulta; Harangozo, M; Jombik, J [Komenskeho Univ., Bratislava (Czechoslovakia). Farmaceuticka Fakulta

    1980-01-01

    A method for the determination of salicylic, acetylsalicylic and benzoic acids in officinal pharmaceutical based on radiometric titration with 0.1 mol.l/sup -1/ NaOH was developed. The end-point was detected with the aid of radioactive glass kryptonate. After the end-point, the excess titrant attacks the glass surface layers and this results in releasing /sup 85/Kr, and consequently, in decreasing the radioactivity of the kryptonate employed. The radioactive kryptonate used as an indicator was prepared by the bombardment of glass with accelerated /sup 85/Kr ions. The developed method is simple, accurate and correct.

  16. Endpoint-based parallel data processing in a parallel active messaging interface of a parallel computer

    Science.gov (United States)

    Archer, Charles J.; Blocksome, Michael A.; Ratterman, Joseph D.; Smith, Brian E.

    2014-08-12

    Endpoint-based parallel data processing in a parallel active messaging interface (`PAMI`) of a parallel computer, the PAMI composed of data communications endpoints, each endpoint including a specification of data communications parameters for a thread of execution on a compute node, including specifications of a client, a context, and a task, the compute nodes coupled for data communications through the PAMI, including establishing a data communications geometry, the geometry specifying, for tasks representing processes of execution of the parallel application, a set of endpoints that are used in collective operations of the PAMI including a plurality of endpoints for one of the tasks; receiving in endpoints of the geometry an instruction for a collective operation; and executing the instruction for a collective operation through the endpoints in dependence upon the geometry, including dividing data communications operations among the plurality of endpoints for one of the tasks.

  17. Alternative Endpoints and Approaches for the Remediation of Contaminated Groundwater at Complex Sites - 13426

    Energy Technology Data Exchange (ETDEWEB)

    Deeb, Rula A.; Hawley, Elisabeth L. [ARCADIS, U.S., 2000 Powell St., 7th Floor, Emeryville, California 94608 (United States)

    2013-07-01

    The goal of United States (U.S.) Department of Energy's (DOE)'s environmental remediation programs is to restore groundwater to beneficial use, similar to many other Federal and state environmental cleanup programs. Based on past experience, groundwater remediation to pre-contamination conditions (i.e., drinking water standards or non-detectable concentrations) can be successfully achieved at many sites. At a subset of the most complex sites, however, complete restoration is not likely achievable within the next 50 to 100 years using today's technology. This presentation describes several approaches used at complex sites in the face of these technical challenges. Many complex sites adopted a long-term management approach, whereby contamination was contained within a specified area using active or passive remediation techniques. Consistent with the requirements of their respective environmental cleanup programs, several complex sites selected land use restrictions and used risk management approaches to accordingly adopt alternative cleanup goals (alternative endpoints). Several sites used long-term management designations and approaches in conjunction with the alternative endpoints. Examples include various state designations for groundwater management zones, technical impracticability (TI) waivers or greater risk waivers at Superfund sites, and the use of Monitored Natural Attenuation (MNA) or other passive long-term management approaches over long time frames. This presentation will focus on findings, statistics, and case studies from a recently-completed report for the Department of Defense's Environmental Security Technology Certification Program (ESTCP) (Project ER-0832) on alternative endpoints and approaches for groundwater remediation at complex sites under a variety of Federal and state cleanup programs. The primary objective of the project was to provide environmental managers and regulators with tools, metrics, and information needed

  18. Alternative Endpoints and Approaches for the Remediation of Contaminated Groundwater at Complex Sites - 13426

    International Nuclear Information System (INIS)

    Deeb, Rula A.; Hawley, Elisabeth L.

    2013-01-01

    The goal of United States (U.S.) Department of Energy's (DOE)'s environmental remediation programs is to restore groundwater to beneficial use, similar to many other Federal and state environmental cleanup programs. Based on past experience, groundwater remediation to pre-contamination conditions (i.e., drinking water standards or non-detectable concentrations) can be successfully achieved at many sites. At a subset of the most complex sites, however, complete restoration is not likely achievable within the next 50 to 100 years using today's technology. This presentation describes several approaches used at complex sites in the face of these technical challenges. Many complex sites adopted a long-term management approach, whereby contamination was contained within a specified area using active or passive remediation techniques. Consistent with the requirements of their respective environmental cleanup programs, several complex sites selected land use restrictions and used risk management approaches to accordingly adopt alternative cleanup goals (alternative endpoints). Several sites used long-term management designations and approaches in conjunction with the alternative endpoints. Examples include various state designations for groundwater management zones, technical impracticability (TI) waivers or greater risk waivers at Superfund sites, and the use of Monitored Natural Attenuation (MNA) or other passive long-term management approaches over long time frames. This presentation will focus on findings, statistics, and case studies from a recently-completed report for the Department of Defense's Environmental Security Technology Certification Program (ESTCP) (Project ER-0832) on alternative endpoints and approaches for groundwater remediation at complex sites under a variety of Federal and state cleanup programs. The primary objective of the project was to provide environmental managers and regulators with tools, metrics, and information needed to evaluate

  19. The Comparison of the Outcomes between Primary PCI, Fibrinolysis, and No Reperfusion in Patients ≥ 75 Years Old with ST-Segment Elevation Myocardial Infarction: Results from the Chinese Acute Myocardial Infarction (CAMI) Registry.

    Science.gov (United States)

    Peiyuan, He; Jingang, Yang; Haiyan, Xu; Xiaojin, Gao; Ying, Xian; Yuan, Wu; Wei, Li; Yang, Wang; Xinran, Tang; Ruohua, Yan; Chen, Jin; Lei, Song; Xuan, Zhang; Rui, Fu; Yunqing, Ye; Qiuting, Dong; Hui, Sun; Xinxin, Yan; Runlin, Gao; Yuejin, Yang

    2016-01-01

    Only a few randomized trials have analyzed the clinical outcomes of elderly ST-segment elevation myocardial infarction (STEMI) patients (≥ 75 years old). Therefore, the best reperfusion strategy has not been well established. An observational study focused on clinical outcomes was performed in this population. Based on the national registry on STEMI patients, the in-hospital outcomes of elderly patients with different reperfusion strategies were compared. The primary endpoint was defined as death. Secondary endpoints included recurrent myocardial infarction, ischemia driven revascularization, myocardial infarction related complications, and major bleeding. Multivariable regression analysis was performed to adjust for the baseline disparities between the groups. Patients who had primary percutaneous coronary intervention (PCI) or fibrinolysis were relatively younger. They came to hospital earlier, and had lower risk of death compared with patients who had no reperfusion. The guideline recommended medications were more frequently used in patients with primary PCI during the hospitalization and at discharge. The rates of death were 7.7%, 15.0%, and 19.9% respectively, with primary PCI, fibrinolysis, and no reperfusion (P PCI also had lower rates of heart failure, mechanical complications, and cardiac arrest compared with fibrinolysis and no reperfusion (P PCI, fibrinolysis, and no reperfusion group (P > 0.05). In the multivariable regression analysis, primary PCI outweighs no reperfusion in predicting the in-hospital death in patients ≥ 75 years old. However, fibrinolysis does not. Early reperfusion, especially primary PCI was safe and effective with absolute reduction of mortality compared with no reperfusion. However, certain randomized trials were encouraged to support the conclusion.

  20. Rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study : a cluster randomised controlled trial

    NARCIS (Netherlands)

    Valk, Mark J.; Hoes, Arno W.; Mosterd, Arend; Landman, Marcel A.; Broekhuizen, Berna D L; Rutten, Frans H.

    2015-01-01

    BACKGROUND: Heart failure (HF) is mainly detected and managed in primary care, but the care is considered suboptimal. We present the rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study. In this study we assess the

  1. Verification of models for ballistic movement time and endpoint variability.

    Science.gov (United States)

    Lin, Ray F; Drury, Colin G

    2013-01-01

    A hand control movement is composed of several ballistic movements. The time required in performing a ballistic movement and its endpoint variability are two important properties in developing movement models. The purpose of this study was to test potential models for predicting these two properties. Twelve participants conducted ballistic movements of specific amplitudes using a drawing tablet. The measured data of movement time and endpoint variability were then used to verify the models. This study was successful with Hoffmann and Gan's movement time model (Hoffmann, 1981; Gan and Hoffmann 1988) predicting more than 90.7% data variance for 84 individual measurements. A new theoretically developed ballistic movement variability model, proved to be better than Howarth, Beggs, and Bowden's (1971) model, predicting on average 84.8% of stopping-variable error and 88.3% of aiming-variable errors. These two validated models will help build solid theoretical movement models and evaluate input devices. This article provides better models for predicting end accuracy and movement time of ballistic movements that are desirable in rapid aiming tasks, such as keying in numbers on a smart phone. The models allow better design of aiming tasks, for example button sizes on mobile phones for different user populations.

  2. Imaging biomarkers as surrogate endpoints for drug development

    International Nuclear Information System (INIS)

    Richter, Wolf S.

    2006-01-01

    The employment of biomarkers (including imaging biomarkers, especially PET) in drug development has gained increasing attention during recent years. This has been partly stimulated by the hope that the integration of biomarkers into drug development programmes may be a means to increase the efficiency and effectiveness of the drug development process by early identification of promising drug candidates - thereby counteracting the rising costs of drug development. More importantly, however, the interest in biomarkers for drug development is the logical consequence of recent advances in biosciences and medicine which are leading to target-specific treatments in the framework of ''personalised medicine''. A considerable proportion of target-specific drugs will show effects in subgroups of patients only. Biomarkers are a means to identify potential responders, or patient subgroups at risk for specific side-effects. Biomarkers are used in early drug development in the context of translational medicine to gain information about the drug's potential in different patient groups and disease states. The information obtained at this stage is mainly important for designing subsequent clinical trials and to identify promising drug candidates. Biomarkers in later phases of clinical development may - if properly validated - serve as surrogate endpoints for clinical outcomes. Regulatory agencies in the EU and the USA have facilitated the use of biomarkers early in the development process. The validation of biomarkers as surrogate endpoints is part of FDA's ''critical path initiative''. (orig.)

  3. Time-dependent efficacy of longitudinal biomarker for clinical endpoint.

    Science.gov (United States)

    Kolamunnage-Dona, Ruwanthi; Williamson, Paula R

    2018-06-01

    Joint modelling of longitudinal biomarker and event-time processes has gained its popularity in recent years as they yield more accurate and precise estimates. Considering this modelling framework, a new methodology for evaluating the time-dependent efficacy of a longitudinal biomarker for clinical endpoint is proposed in this article. In particular, the proposed model assesses how well longitudinally repeated measurements of a biomarker over various time periods (0,t) distinguish between individuals who developed the disease by time t and individuals who remain disease-free beyond time t. The receiver operating characteristic curve is used to provide the corresponding efficacy summaries at various t based on the association between longitudinal biomarker trajectory and risk of clinical endpoint prior to each time point. The model also allows detecting the time period over which a biomarker should be monitored for its best discriminatory value. The proposed approach is evaluated through simulation and illustrated on the motivating dataset from a prospective observational study of biomarkers to diagnose the onset of sepsis.

  4. Cortical plasticity as a new endpoint measurement for chronic pain

    Directory of Open Access Journals (Sweden)

    Zhuo Min

    2011-07-01

    Full Text Available Abstract Animal models of chronic pain are widely used to investigate basic mechanisms of chronic pain and to evaluate potential novel drugs for treating chronic pain. Among the different criteria used to measure chronic pain, behavioral responses are commonly used as the end point measurements. However, not all chronic pain conditions can be easily measured by behavioral responses such as the headache, phantom pain and pain related to spinal cord injury. Here I propose that cortical indexes, that indicate neuronal plastic changes in pain-related cortical areas, can be used as endpoint measurements for chronic pain. Such cortical indexes are not only useful for those chronic pain conditions where a suitable animal model is lacking, but also serve as additional screening methods for potential drugs to treat chronic pain in humans. These cortical indexes are activity-dependent immediate early genes, electrophysiological identified plastic changes and biochemical assays of signaling proteins. It can be used to evaluate novel analgesic compounds that may act at peripheral or spinal sites. I hope that these new cortical endpoint measurements will facilitate our search for new, and more effective, pain medicines, and help to reduce false lead drug targets.

  5. A yeast screening system for simultaneously monitoring multiple genetic endpoints

    International Nuclear Information System (INIS)

    Dixon, M.L.; Mortimer, R.K.

    1986-01-01

    Mutation, recombination, and mitochondrial deficiencies have been proposed to have roles in the carcinogenic process. The authors describe a diploid strain of the yeast Saccharomyces cerevisiae capable of detecting this wide spectrum of genetic changes. The markers used for monitoring these events have been especially well characterized genetically. Ultraviolet light was chosen as a model carcinogenic agent to test this system. In addition to highly significant increases in the frequencies of each genetic change, increases in the absolute numbers of each change indicated induction and not selective survival. The relative amounts of each type of genetic change varied with dose. The wide spectrum of endpoints monitored in the XD83 yeast system may allow the detection of certain carcinogens and other genetically toxic agents which have escaped detection in more limited systems. Since only one strain is required to simultaneously monitor these genetic changes, this assay system should facilitate comparisons of the induced changes and be more efficient than using multiple strains to monitor the same endpoints. (Auth.)

  6. Parametric Study of Beta-Endpoint Energy in Direct Energy Converters

    Science.gov (United States)

    2007-01-01

    value to the endpoint energy of nickel-63 ( Ni63 ), whose endpoint energy is 66 keV. Only an approximation is sought. Nickel-63 is an easily...is known to vary from Sr90’s spectrum, where instead of peaking at approximately one third of the endpoint energy, the peak of Ni63 ’s output spectrum

  7. Weight related health status of patients treated by dietitians in primary care practice: first results of a cohort study : first results of a cohort study

    NARCIS (Netherlands)

    Govers, E.; Seidell, J.C.; Visser, M.; Brouwer, I.A.

    2014-01-01

    BACKGROUND: Overweight and obesity are common in the Netherlands: in 2006 51% of adult men and 42% of adult women were overweight; 10% of men and 12% of women were obese. Patients with overweight or obesity in the Netherlands are often referred to dietitians in primary care for weight loss

  8. Electroacupuncture Modulates Reproductive Hormone Levels in Patients with Primary Ovarian Insufficiency: Results from a Prospective Observational Study

    Directory of Open Access Journals (Sweden)

    Kehua Zhou

    2013-01-01

    Full Text Available To investigate the effects of electroacupuncture (EA on serum FSH, E2, and LH levels, women with primary ovarian insufficiency (POI were treated with EA once a day, five times a week for the first four weeks and once every other day, three times a week, for the following two months, and then were followed up for three months. Serum E2, FSH, and LH levels were measured at baseline, at the end of treatment, and during followup. A total of 11 women with POI were included in this prospective consecutive case series study. Compared with baseline, patients’ serum E2 increased, FSH decreased, and LH decreased (P=0.002, 0.001, and 0.002, resp. after EA treatment, and these effects persisted during followup. With treatment, 10 patients resumed menstruation (10/11, 90.91%, whereas one patient remained amenorrhea. During followup, two patients, including the one with amenorrhea during treatment, reported absence of menstruation. Temporary pain occurred occasionally, and no other adverse events were found during treatment. The results suggest that EA could decrease serum FSH and LH levels and increase serum E2 level in women with POI with little or no side effects; however, further randomized control trials are needed.

  9. Further effort is needed to improve management of chronic pain in primary care. Results from the Arkys project

    Directory of Open Access Journals (Sweden)

    Gaetano Piccinocchi

    2016-06-01

    Full Text Available Treatment of chronic pain is challenging. The Arkys project was initiated in Italy to assist general practitioners (GPs in the management of chronic pain. The main objective of this study was to determine the usefulness of Arkys for selecting new therapeutic strategies. An online interactive questionnaire for assessing pain and guiding therapeutic decisions was made available to GPs participating to Arkys. The GPs were invited to complete the questionnaire for each patient who presented moderate-severe chronic pain, and to decide on a new analgesic treatment based on the information provided by the questionnaire. Two hundred and forty four GPs participated with a total of 3035 patients. Patients (mean age 68.9 years had mostly chronic non-cancer pain (87.7%. In 42.3%, pain had neuropathic components. Only 53.6% of patients were in treatment with analgesics (strong opioids, 38.9%; NSAIDs, 32.6%; weak opioids, 25.6%; anti-epileptics, 17.3%; paracetamol, 14.9%. Use of the questionnaire resulted in the prescription of analgesics to all patients and in increased prescription of strong opioids (69.7%. NSAID prescription decreased (12.8%, while anti-epileptics use remained stable. These findings show that current management of chronic pain in primary care is far from optimal and that efforts are needed to educate GPs and improve guideline implementation.

  10. Measurement of H, He, C and O Cosmic ray primaries preliminary results from the CREAM II experiment

    CERN Document Server

    Mognet, Samuel

    The direct measurement of the energy spectrum and composition of the incoming cosmic-ray flux at multi-TeV energies is of great interest. A feature located somewhere between 1000-10,000 TeV in the all-particle spectrum, referred to as the ‘knee’ characterized by a steepening of the power-law flux, has been observed by ground-based detectors for many years. It is believed to be related to an upper limit or change in efficiency of the Galactic accelerators of cosmic rays and/or properties of the propagation of cosmic rays in the Galaxy. Presented here is a preliminary analysis of the flux of primary H, He, C and O cosmic-ray species measured using the CREAM II instrument. This analysis is conducted using the Penn State-built Timing Charge Detector, distinct from other charge detectors used in alternative published CREAM II results. The second Antarctic flight of the CREAM instrument had a ∼ 28 day flight in the 2005-2006 Antarctic flight season. The instrument was launched on December 16th 2005 from Willi...

  11. Catalytic supercritical water gasification of primary paper sludge using a homogeneous and heterogeneous catalyst: Experimental vs thermodynamic equilibrium results.

    Science.gov (United States)

    Louw, Jeanne; Schwarz, Cara E; Burger, Andries J

    2016-02-01

    H2, CH4, CO and CO2 yields were measured during supercritical water gasification (SCWG) of primary paper waste sludge (PWS) at 450°C. Comparing these yields with calculated thermodynamic equilibrium values offer an improved understanding of conditions required to produce near-equilibrium yields. Experiments were conducted at different catalyst loads (0-1g/gPWS) and different reaction times (15-120min) in a batch reactor, using either K2CO3 or Ni/Al2O3-SiO2 as catalyst. K2CO3 up to 1g/gPWS increased the H2 yield significantly to 7.5mol/kgPWS. However, these yields and composition were far from equilibrium values, with carbon efficiency (CE) and energy recovery (ER) of only 29% and 20%, respectively. Addition of 0.5-1g/gPWS Ni/Al2O3-SiO2 resulted in high H2 and CH4 yields (6.8 and 14.8mol/kgPWS), CE of 84-90%, ER of 83% and a gas composition relatively close to the equilibrium values (at hold times of 60-120min). Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. Initial results of shoulder MRI in external rotation after primary shoulder dislocation and after immobilization in external rotation

    International Nuclear Information System (INIS)

    Pennekamp, W.; Nicolas, V.; Gekle, C.; Seybold, D.

    2006-01-01

    Purpose: A change in the strategy for treating primary anterior traumatic dislocation of the shoulder has occurred. To date, brief fixation of internal rotation via a Gilchrist bandage has been used. Depending on the patient's age, a redislocation is seen in up to 90% of cases. This is due to healing of the internally rotated labrum-ligament tear in an incorrect position. In the case of external rotation of the humerus, better repositioning of the labrum ligament complex is achieved. Using MRI of the shoulder in external rotation, the extent of the improved labrum-ligament adjustment can be documented, and the indication of immobilization of the shoulder in external rotation can be derived. The aim of this investigation is to describe the degree of position changing of the labrum-ligament tear in internal and external rotation. Materials and Methods: 10 patients (9 male, 1 female, mean age 30.4 years, range 15-43 years) with a primary anterior dislocation of the shoulder without hyper laxity of the contra lateral side and labrum-ligament lesion substantiated by MRI were investigated using a standard shoulder MRI protocol (PD-TSE axial fs, PD-TSE coronar fs, T2-TSE sagittal, T1-TSE coronar) by an axial PD-TSE sequence in internal and external rotation. The dislocation and separation of the anterior labrum-ligament complex were measured. The shoulders were immobilized in 10 external rotation for 3 weeks. After 6 weeks a shoulder MRI in internal rotation was performed. Results: In all patients there was a significantly better position of the labrum-ligament complex of the inferior rim in external rotation, because of the tension of the ventral capsule and the subscapular muscle. In the initial investigation, the separation of the labrum-ligament complex in internal rotation was 0.44±0.27 mm and the dislocation was 0.45±0.33 mm. In external rotation the separation was 0.01±0.19 mm and the dislocation was -0.08±0.28 mm. After 6 weeks of immobilization in 10 external

  13. Combined effects of gamma irradiation and cadmium on cellular and population-level endpoints of the micro-alga Pseudokirchneriella subcapitata

    Energy Technology Data Exchange (ETDEWEB)

    Bradshaw, C. [Stockholm University (Sweden); Abdul Meseh, D.; Alasawi, H.; Qiang, M.; Nascimento, F. [Dept of Ecology, Environment and Plant Sciences (Sweden)

    2014-07-01

    A major challenge in evaluating the risks of radiation to organisms is that radioactive substances often co-occur with other contaminants in the environment. The combined effects of multiple contaminants is poorly understood, particularly where radiation is involved, but mixture toxicity can give rise to synergistic, antagonistic or additive effects. The challenge of understanding mixture toxicity in a radiation context is the focus of one of the work packages of the STAR EU Network of Excellence in Radioecology, of which this study is a part. This paper presents results from an experiment where the green micro-alga Pseudokirchneriella subcapitata was exposed to both acute external gamma irradiation and the toxic metal cadmium (Cd) (over 72 hours); the experiment had a fully factorial design with 4 gamma doses and 4 Cd concentrations. The endpoints measured were chosen to reflect subcellular, cellular and population-level effects: antioxidant enzyme expression; membrane damage; protein, vitamin and pigment content of the cells; individual cell biomass and growth; population growth (biomass per ml and cells per ml). Preliminary results suggest effects of both Cd and gamma on some of the cellular and subcellular endpoints such as thiamine (vitamin B1) and chlorophyll concentrations in the cells, and individual cell biomass. In some cases interactive effects of the combined Cd and gamma treatments were seen, and these appeared to be dose level dependent. This lack of a consistent pattern of interactive mixture toxicity effects across the endpoints measured means that such effects would be very hard to predict in a risk assessment context. The lack of measurable effects at the population level was probably due to the short experimental duration (72 hours). Other experiments in our research group on the same micro-alga species that have looked at longer term effects (weeks) have shown that effects may not manifest themselves until at least a week after an acute gamma

  14. Depressive symptoms and depression in people screened positive for dementia in primary care - results of the DelpHi-study.

    Science.gov (United States)

    Thyrian, Jochen René; Eichler, Tilly; Reimann, Melanie; Wucherer, Diana; Dreier, Adina; Michalowsky, Bernhard; Hoffmann, Wolfgang

    2016-06-01

    Dementia and depression are common syndromes in the elderly. There is lack of knowledge concerning the frequency of depressive symptoms in people with dementia (PWD) and factors associated with depression. The aim of this analysis is to (a) describe the frequency of depressive symptoms in people screened positive for dementia, (b) describe differences between PWD with and without depressive symptoms, and (c) analyze associations between depressive symptoms and other dementia-related variables. Analyses are based on data of the GP-based intervention trial DelpHi-MV. A sample of 430 (6.29%) people screened positive for dementia in primary care was analyzed regarding depression according to the German version of the Geriatric Depression Scale (GDS, 15-items), demographic variables, and dementia/depression-related variables. Multivariate analyses were conducted to identify factors associated with depressive symptoms. The mean GDS-score of depressive symptoms in n = 430 PWD was m = 3.21 (SD 2.45) with 67 PWD (15.55%) showing clinically relevant depression (GDS depression and n = 62 (14.42%) received antidepressive drug treatment. Depressive symptoms are significantly associated with age (OR = 0.93), functional impairment (OR = 1.36), and quality of life (OR = 0.01, CI: 0.00-0.06). Our results support previous findings that clinically relevant depressive symptoms are more common in people screened positive for dementia than in the general population and are often missed or mismanaged. Our findings underline the importance of managing quality of life, functional status, or depressive symptoms. Also, the results highlight the benefit of including the partner (and probably other carers) for adequate treatment of PWD.

  15. Treatment results for hypopharyngeal cancer by different treatment strategies and its secondary primary- an experience in Taiwan

    Directory of Open Access Journals (Sweden)

    Lin Chien-Yu

    2010-10-01

    Full Text Available Abstract Purpose The aim of this study was to evaluate treatment results in our hypopharyngeal cancer patients. Patients and Methods A total of three hundred and ninety five hypopharyngeal cancer patients received radical treatment at our hospital; 96% were male. The majority were habitual smokers (88%, alcohol drinkers (73% and/or betel quid chewers (51%. All patients received a CT scan or MRI for tumor staging before treatment. The stage distribution was stage I: 2 (0.5%; stage II: 22 (5.6%; stage III: 57 (14.4% and stage IV: 314 (79.5%. Radical surgery was used first in 81 patients (20.5%, and the remaining patients (79.5% received organ preservation-intended treatment (OPIT. In the OPIT group, 46 patients received radiotherapy alone, 156 patients received chemotherapy followed by radiotherapy (CT/RT and 112 patients received concomitant chemo-radiotherapy (CCRT. Results The five-year overall survival rates for stages I/II, III and IV were 49.5%, 47.4% and 18.6%, respectively. There was no significant difference in overall and disease-specific survival rates between patients who received radical surgery first and those who received OPIT. In the OPIT group, CCRT tended to preserve the larynx better (p = 0.088, with three-year larynx preservation rates of 44.8% for CCRT and 27.2% for CT/RT. Thirty-seven patients developed a second malignancy, with an annual incidence of 4.6%. Conclusions There was no survival difference between OPIT and radical surgery in hypopharyngeal cancer patients at our hospital. CCRT may offer better laryngeal preservation than RT alone or CT/RT. However, prospective studies are still needed to confirm this finding. Additionally, second primary cancers are another important issue for hypopharyngeal cancer management.

  16. Primary water chemistry optimization for extended fuel cycle operation. Results of the 'Duo experimentation' after three cycles

    International Nuclear Information System (INIS)

    Viricel, L.; Andrieu, C.; Segura, J.C.; Rocher, A.; Thomazet, J.; Clinard, M.H.; Dacquait, F.

    2002-01-01

    The primary coolant conditioning in French nuclear power plants is essentially based on the boron-lithium coordinated chemistry, with a target pH of 7.2 at 300 C and a maximum lithium concentration of 2.2 mg/kg. In 1996, EDF 1300 MWe units began operating 18-month fuel cycles, increasing boron concentrations at the beginning of the cycles. Since today the maximum lithium concentration in normal operation is 2.2 mg/kg, extended cycle operation results in a decrease in the pH at the beginning of the cycles, which may possibly lead to deposits in RCS, and particularly on the fuel cladding, and increased dose rates. It has to be noted that today, the fuel assemblies maximum burnup is set at 52 GWd/tU. One solution is to adjust the pH by increasing the lithium content at the beginning of the cycles, which is easy to implement and does not require any modification on the units. Hence, EDF is testing a ''modified'' chemistry regime in the > during 4 fuel cycles, with a maximum authorized lithium content of 3.5 mg/kg at the beginning of the cycles in the Cattenom 2 pilot unit. The Golfech 1 reference unit implements a standard boron-lithium coordination pH 300 7.2. The major goal of the experimentation is to assess the impact of elevated lithium concentrations at the beginning of the cycles on fuel cladding oxide behavior, mass transport and dose rates. This paper presents the results of the first three cycles of the Duo experimentation. (author)

  17. Predicting treatment effect from surrogate endpoints and historical trials: an extrapolation involving probabilities of a binary outcome or survival to a specific time.

    Science.gov (United States)

    Baker, Stuart G; Sargent, Daniel J; Buyse, Marc; Burzykowski, Tomasz

    2012-03-01

    Using multiple historical trials with surrogate and true endpoints, we consider various models to predict the effect of treatment on a true endpoint in a target trial in which only a surrogate endpoint is observed. This predicted result is computed using (1) a prediction model (mixture, linear, or principal stratification) estimated from historical trials and the surrogate endpoint of the target trial and (2) a random extrapolation error estimated from successively leaving out each trial among the historical trials. The method applies to either binary outcomes or survival to a particular time that is computed from censored survival data. We compute a 95% confidence interval for the predicted result and validate its coverage using simulation. To summarize the additional uncertainty from using a predicted instead of true result for the estimated treatment effect, we compute its multiplier of standard error. Software is available for download. © 2011, The International Biometric Society No claim to original US government works.

  18. Angiographic core laboratory reproducibility analyses: implications for planning clinical trials using coronary angiography and left ventriculography end-points.

    Science.gov (United States)

    Steigen, Terje K; Claudio, Cheryl; Abbott, David; Schulzer, Michael; Burton, Jeff; Tymchak, Wayne; Buller, Christopher E; John Mancini, G B

    2008-06-01

    To assess reproducibility of core laboratory performance and impact on sample size calculations. Little information exists about overall reproducibility of core laboratories in contradistinction to performance of individual technicians. Also, qualitative parameters are being adjudicated increasingly as either primary or secondary end-points. The comparative impact of using diverse indexes on sample sizes has not been previously reported. We compared initial and repeat assessments of five quantitative parameters [e.g., minimum lumen diameter (MLD), ejection fraction (EF), etc.] and six qualitative parameters [e.g., TIMI myocardial perfusion grade (TMPG) or thrombus grade (TTG), etc.], as performed by differing technicians and separated by a year or more. Sample sizes were calculated from these results. TMPG and TTG were also adjudicated by a second core laboratory. MLD and EF were the most reproducible, yielding the smallest sample size calculations, whereas percent diameter stenosis and centerline wall motion require substantially larger trials. Of the qualitative parameters, all except TIMI flow grade gave reproducibility characteristics yielding sample sizes of many 100's of patients. Reproducibility of TMPG and TTG was only moderately good both within and between core laboratories, underscoring an intrinsic difficulty in assessing these. Core laboratories can be shown to provide reproducibility performance that is comparable to performance commonly ascribed to individual technicians. The differences in reproducibility yield huge differences in sample size when comparing quantitative and qualitative parameters. TMPG and TTG are intrinsically difficult to assess and conclusions based on these parameters should arise only from very large trials.

  19. Mental disorders in primary care: prevalence and co-morbidity among disorders. results from the functional illness in primary care (FIP) study.

    Science.gov (United States)

    Toft, Tomas; Fink, Per; Oernboel, Eva; Christensen, Kaj; Frostholm, Lisbeth; Olesen, Frede

    2005-08-01

    Prevalence and co-occurrence of mental disorders is high among patients consulting their family general practitioner (GP) for a new health problem, but data on diagnostics and socio-demographics are sketchy. A cross-sectional two-phase epidemiological study. A total of 1785 consecutive patients with new complaints, aged 18-65 years, consulting 28 family practices during March-April 2000 in Aarhus County, Denmark were screened, in the waiting room, for mental and somatic symptoms with SCL-8 and SCL-Somatization questionnaires, for illness worry with Whitely-7 and for alcohol dependency with CAGE. In a stratified random sample of 701 patients, physician interviewers established ICD-10 diagnoses using the SCAN interview. Prevalence was calculated using weighted logistic regression, thus correcting for sample skewness. Half of the patients fulfilled criteria for an ICD-10 mental disorders and a third of these for more than one group of disorders. Women had higher prevalence of somatization disorder and overall mental disorders than men. Men had higher prevalence of alcohol abuse and hypochondriasis than women. Psychiatric morbidity tended to increase with age. Prevalence of somatoform disorders was 35.9% (95% CI 30.4-41.9), anxiety disorders 164% (95% CI 12.7-20.9), mood disorders 13.5% (95% CI 11.1-16.3), organic mental disorders 3.1% (95% CI 1.6-5.7) and alcohol abuse 2.2% (95% CI 1.5-3.1). Co-morbidities between these groups were highest for anxiety disorders, where 89% also had another mental diagnosis, and lowest for somatoform disorders with 39%. ICD-10 mental disorders are very prevalent in primary care and there is a high co-occurrence between most disorders. Somatoform disorders, however, more often than not exist without other mental disorders.

  20. Quality of life is modestly improved in older patients with mild primary hyperparathyroidism postoperatively: results of a prospective multicenter study.

    Science.gov (United States)

    Blanchard, Claire; Mathonnet, Muriel; Sebag, Frédéric; Caillard, Cécile; Kubis, Caroline; Drui, Delphine; van Nuvel, Elise; Ansquer, Catherine; Henry, Jean-François; Masson, Damien; Kraeber-Bodéré, Françoise; Hardouin, Jean-Benoît; Zarnegar, Rasa; Hamy, Antoine; Mirallié, Eric

    2014-10-01

    The objectives of this study were to evaluate, in mild primary hyperparathyroidism (pHPT) patients, the quality of life (QoL) using the SF-36 questionnaire before and after parathyroidectomy and to detect preoperatively patients who benefit the most from surgery. Most pHPT patients present a mild pHPT defined by calcemia ≤11.4 mg/dL. For these patients, there is debate about whether they should be managed with surveillance, medical therapy, or surgery. A prospective multicenter study investigated QoL (SF-36) in patients with mild pHPT before and after parathyroidectomy in four university hospitals. Laboratory results and SF-36 scores were obtained preoperatively and postoperatively (3, 6, and 12 months). One hundred sixteen patients were included. After surgery, the biochemical cure rate was 98%. Preoperatively, the mental component summary and the physical component summary (PCS) were 38.69 of 100 and 39.53 of 100, respectively. At 1 year, the MCS and the PCS were 41.29 of 100 and 42.03 of 100. The subgroup analysis showed a more significant improvement in patients < 70 years and with calcemia ≥10.4 mg/dL. Postoperative PCS was correlated with age and preoperative PCS: variation = 32.11 - 0.21 × age - 0.4 × preoperative PCS. Men did not improve their MCS postoperatively. Only women with a preoperative MCS <43.6 of 100 showed postoperative improvement. This study showed, in patients with mild pHPT, an improvement of QoL 1 year after parathyroidectomy. Patients <70 years and with calcemia ≥10.4 mg/dL had a more significant improvement.

  1. Treatment results for hypopharyngeal cancer by different treatment strategies and its secondary primary- an experience in Taiwan

    International Nuclear Information System (INIS)

    Chang, Morgan Fu-Ti; Chang, Joseph Tung-Chieh; Wang, Hung-Ming; Kang, Chung-Jan; Huang, Shiang-Fu; Lin, Chien-Yu; Fang, Kang-Hsing; Chen, Eric Yen-Chao; Chen, I-How; Liao, Chun-Ta

    2010-01-01

    The aim of this study was to evaluate treatment results in our hypopharyngeal cancer patients. A total of three hundred and ninety five hypopharyngeal cancer patients received radical treatment at our hospital; 96% were male. The majority were habitual smokers (88%), alcohol drinkers (73%) and/or betel quid chewers (51%). All patients received a CT scan or MRI for tumor staging before treatment. The stage distribution was stage I: 2 (0.5%); stage II: 22 (5.6%); stage III: 57 (14.4%) and stage IV: 314 (79.5%). Radical surgery was used first in 81 patients (20.5%), and the remaining patients (79.5%) received organ preservation-intended treatment (OPIT). In the OPIT group, 46 patients received radiotherapy alone, 156 patients received chemotherapy followed by radiotherapy (CT/RT) and 112 patients received concomitant chemo-radiotherapy (CCRT). The five-year overall survival rates for stages I/II, III and IV were 49.5%, 47.4% and 18.6%, respectively. There was no significant difference in overall and disease-specific survival rates between patients who received radical surgery first and those who received OPIT. In the OPIT group, CCRT tended to preserve the larynx better (p = 0.088), with three-year larynx preservation rates of 44.8% for CCRT and 27.2% for CT/RT. Thirty-seven patients developed a second malignancy, with an annual incidence of 4.6%. There was no survival difference between OPIT and radical surgery in hypopharyngeal cancer patients at our hospital. CCRT may offer better laryngeal preservation than RT alone or CT/RT. However, prospective studies are still needed to confirm this finding. Additionally, second primary cancers are another important issue for hypopharyngeal cancer management

  2. Phase II Trials for Heterogeneous Patient Populations with a Time-to-Event Endpoint.

    Science.gov (United States)

    Jung, Sin-Ho

    2017-07-01

    In this paper, we consider a single-arm phase II trial with a time-to-event end-point. We assume that the study population has multiple subpopulations with different prognosis, but the study treatment is expected to be similarly efficacious across the subpopulations. We review a stratified one-sample log-rank test and present its sample size calculation method under some practical design settings. Our sample size method requires specification of the prevalence of subpopulations. We observe that the power of the resulting sample size is not very sensitive to misspecification of the prevalence.

  3. Adaptive endpoint detection of seismic signal based on auto-correlated function

    International Nuclear Information System (INIS)

    Fan Wanchun; Shi Ren

    2001-01-01

    Based on the analysis of auto-correlation function, the notion of the distance between auto-correlation function was quoted, and the characterization of the noise and the signal with noise were discussed by using the distance. Then, the method of auto- adaptable endpoint detection of seismic signal based on auto-correlated similarity was summed up. The steps of implementation and determining of the thresholds were presented in detail. The experimental results that were compared with the methods based on artificial detecting show that this method has higher sensitivity even in a low signal with noise ratio circumstance

  4. Low dose response analysis through a cytogenetic end-point

    International Nuclear Information System (INIS)

    Bojtor, I.; Koeteles, G.J.

    1998-01-01

    The effects of low doses were studied on human lymphocytes of various individuals. The frequency of micronuclei in cytokinesis-blocked cultured lymphocytes was taken as end-point. The probability distribution of radiation-induced increment was statistically proved and identified as to be asymmetric when the blood samples had been irradiated with doses of 0.01-0.05 Gy of X-rays, similarly to that in unirradiated control population. On the contrary, at or above 1 Gy the corresponding normal curve could be accepted only reflecting an approximately symmetrical scatter of the increments about their mean value. It was found that the slope as well as the closeness of correlation of the variables considerably changed when lower and lower dose ranges had been selected. Below approximately 0.2 Gy even an unrelatedness was found betwen the absorbed dose and the increment

  5. Primary treatment of endometrial carcinoma with high-dose-rate brachytherapy: results of 12 years of experience with 280 patients

    International Nuclear Information System (INIS)

    Knocke, Tomas H.; Kucera, Herwig; Weidinger, Barbara; Hoeller, Walpurga; Poetter, Richard

    1997-01-01

    Purpose: This study aimed to evaluate the efficacy of high-dose-rate brachytherapy (HDRB) in the primary treatment of endometrial carcinoma. The results of 12 years of experience (1981-1992) covering 280 patients (mean age 72 years) and their follow-up over 10 years (mean 55 months) are reported. Methods and Materials: Staging was based on clinical examination and fractionated curettage. There were 116 patients in clinical Stage Ia, 119 in Stage Ib, 37 in Stage II, and 8 in Stage III. HDRB was performed four to five times (8.5 Gy) with a one-channel intracavitary applicator and one to two times (7 Gy) with an intravaginal cylinder applicator. Overall and disease-specific survival, local control according to stage and histology, and late side effects were analyzed retrospectively (actuarial method). Results: At 5 years, overall survival, disease-specific survival, and local control were 52.7%, 76.6%, and 75.4% (Stage Ia: 63.9%, 84.9%, and 86.0%; Stage Ib: 47.3%, 73.3%, and 68.8%; and Stage II: 40.2%, 68.6%, and 60.5%) according to histopathologic Grade 1: 65.1%, 83.5%, and 77.7%; for Grade 2: 44.7%, 75.4%, and 75.8%; and for Grade 3: 37.7%, 63.9%, and 74.1%. Eight patients showed progressive disease, 64 developed recurrence after a median of 13 months (45 of whom had a local recurrence only, and 6 of whom had a local recurrence with distant metastases), 6 developed a lymph node recurrence only, and 7 developed distant metastases only. The calculated probability for developing a Grade III late side effect was 5.2% at 5 years. Conclusion: At Stages Ia, Ib, and II in endometrial carcinoma, HDRB is a very effective treatment modality with acceptable local control rates and disease-specific survival for patients who are not fit for surgery. During the time frame of 12 years and in 280 patients the method has proven to have a low risk of acute complications and an acceptable risk of long-term side effects

  6. If the results of an article are noteworthy, read the entire article; do not rely on the abstract alone.

    Science.gov (United States)

    Dal-Ré, R; Castell, M V; García-Puig, J

    2015-11-01

    Clinicians typically update their knowledge by reading articles on the Internet. Easy access to the articles' abstracts and a lack of time to access other information sources creates a risk that therapeutic or diagnostic decisions will be made after reading just the abstracts. Occasionally, however, the abstracts of articles from clinical trials that have not obtained statistically significant differences in the primary study endpoint have reported other positive results, for example, of a secondary endpoint or a subgroup analysis. The article, however, correctly reports all results, including those of the primary endpoint. In the abstract, the safety information of the experimental treatment is usually deficient. The whole article should be read if a clinical decision is to be made. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  7. results

    Directory of Open Access Journals (Sweden)

    Salabura Piotr

    2017-01-01

    Full Text Available HADES experiment at GSI is the only high precision experiment probing nuclear matter in the beam energy range of a few AGeV. Pion, proton and ion beams are used to study rare dielectron and strangeness probes to diagnose properties of strongly interacting matter in this energy regime. Selected results from p + A and A + A collisions are presented and discussed.

  8. A model-data comparison of gross primary productivity: Results from the North American Carbon Program site synthesis

    Science.gov (United States)

    Kevin Schaefer; Christopher R. Schwalm; Chris Williams; M. Altaf Arain; Alan Barr; Jing M. Chen; Kenneth J. Davis; Dimitre Dimitrov; Timothy W. Hilton; David Y. Hollinger; Elyn Humphreys; Benjamin Poulter; Brett M. Raczka; Andrew D. Richardson; Alok Sahoo; Peter Thornton; Rodrigo Vargas; Hans Verbeeck; Ryan Anderson; Ian Baker; T. Andrew Black; Paul Bolstad; Jiquan Chen; Peter S. Curtis; Ankur R. Desai; Michael Dietze; Danilo Dragoni; Christopher Gough; Robert F. Grant; Lianhong Gu; Atul Jain; Chris Kucharik; Beverly Law; Shuguang Liu; Erandathie Lokipitiya; Hank A. Margolis; Roser Matamala; J. Harry McCaughey; Russ Monson; J. William Munger; Walter Oechel; Changhui Peng; David T. Price; Dan Ricciuto; William J. Riley; Nigel Roulet; Hanqin Tian; Christina Tonitto; Margaret Torn; Ensheng Weng; Xiaolu Zhou

    2012-01-01

    Accurately simulating gross primary productivity (GPP) in terrestrial ecosystem models is critical because errors in simulated GPP propagate through the model to introduce additional errors in simulated biomass and other fluxes. We evaluated simulated, daily average GPP from 26 models against estimated GPP at 39 eddy covariance flux tower sites across the United States...

  9. Study of the Results in the Acquisition of Core Competencies in Schools That Integrate Primary Education and Music

    Science.gov (United States)

    Andreu Duran, Maria; Godall Castell, Pere; Amador Guillem, Miquel; Castro Morera, Maria

    2017-01-01

    The goal of this research was to carry out an exploratory study on how music education integrated into primary schooling (children from 6 to 12 years old) can help in acquiring the core competencies characteristic of this stage. The study was conducted by developing a validated instrument, pilot-tested for reliability, to assess the eight core…

  10. Primary Prevention of Coronary Artery Disease Among Middle Aged Men in Prague: Twenty-year Follow-up Results

    Czech Academy of Sciences Publication Activity Database

    Boudík, F.; Reissigová, Jindra; Hrach, Karel; Tomečková, Marie; Bultas, J.; Anger, Z.; Aschermann, M.; Zvárová, Jana

    2006-01-01

    Roč. 184, č. 1 (2006), s. 86-93 ISSN 0021-9150 R&D Projects: GA MŠk(CZ) LN00B107 Keywords : primary prevention study * atherosclerosis * cardiovascular diseases * coronary artery disease * Framingham risk function * mortality * risk factors Subject RIV: BA - General Mathematics Impact factor: 3.811, year: 2006

  11. Relationship between Eating Behaviors and Physical Activity among Primary and Secondary School Students: Results of a Cross-Sectional Study

    Science.gov (United States)

    Morin, Pascale; Turcotte, Sylvain; Perreault, Gino

    2013-01-01

    Background: With a view toward developing concerted efforts in fostering healthy eating habits and a physically active lifestyle among young people, a study was carried out to explore associations between eating behavior and physical activity (PA). Methods: In the school district, questionnaires were completed at home by parents of primary school…

  12. The influence of registered nurses and nurse practitioners on patient experience with primary care: results from the Canadian QUALICO-PC study.

    Science.gov (United States)

    Ammi, Mehdi; Ambrose, Sarah; Hogg, Bill; Wong, Sabrina

    2017-12-01

    Nurses, whether registered nurses (RNs) or nurse practitioners (NPs), are becoming key providers of primary care services. While evidence for the influence of NPs on patient experience in primary care is mounting, this is less so for RNs. We use the Canadian component of the international Quality and Costs of Primary Care 2013/14 survey to investigate the mechanisms by which nurses can affect patients' experience in primary care, focusing on accessibility and appropriateness of care. The data allow us to distinguish between family practice RNs, specialised RNs and NPs, and covers all types of patients visiting a primary care clinic in a variety of contexts in all Canadian provinces. In addition to the types of nurses and full-time equivalent (FTE) numbers, we explore the role of nurse autonomy and collaboration. Our regression results show that one of the most important predictors of patient experience is the collaboration between health professionals, whereas nurse staffing in terms of FTE numbers has little influence by itself. Different types of nurses influence different dimensions of accessibility, and the association between patient experience and nurse staffing depends on the number of physicians in the clinic. Our results can inform decision-makers on how to strengthen primary care provision, and particularly in Canadian context, the adaptation of the recently implemented interprofessional primary care teams. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Fourier-transform infrared spectroscopy as a novel approach to providing effect-based endpoints in duckweed toxicity testing.

    Science.gov (United States)

    Hu, Li-Xin; Ying, Guang-Guo; Chen, Xiao-Wen; Huang, Guo-Yong; Liu, You-Sheng; Jiang, Yu-Xia; Pan, Chang-Gui; Tian, Fei; Martin, Francis L

    2017-02-01

    Traditional duckweed toxicity tests only measure plant growth inhibition as an endpoint, with limited effects-based data. The present study aimed to investigate whether Fourier-transform infrared (FTIR) spectroscopy could enhance the duckweed (Lemna minor L.) toxicity test. Four chemicals (Cu, Cd, atrazine, and acetochlor) and 4 metal-containing industrial wastewater samples were tested. After exposure of duckweed to the chemicals, standard toxicity endpoints (frond number and chlorophyll content) were determined; the fronds were also interrogated using FTIR spectroscopy under optimized test conditions. Biochemical alterations associated with each treatment were assessed and further analyzed by multivariate analysis. The results showed that comparable x% of effective concentration (ECx) values could be achieved based on FTIR spectroscopy in comparison with those based on traditional toxicity endpoints. Biochemical alterations associated with different doses of toxicant were mainly attributed to lipid, protein, nucleic acid, and carbohydrate structural changes, which helped to explain toxic mechanisms. With the help of multivariate analysis, separation of clusters related to different exposure doses could be achieved. The present study is the first to show successful application of FTIR spectroscopy in standard duckweed toxicity tests with biochemical alterations as new endpoints. Environ Toxicol Chem 2017;36:346-353. © 2016 SETAC. © 2016 SETAC.

  14. Energetic endpoints provide early indicators of life history effects in a freshwater gastropod exposed to the fungicide, pyraclostrobin.

    Science.gov (United States)

    Fidder, Bridgette N; Reátegui-Zirena, Evelyn G; Olson, Adric D; Salice, Christopher J

    2016-04-01

    Organismal energetics provide important insights into the effects of environmental toxicants. We aimed to determine the effects of pyraclostrobin on Lymnaea stagnalis by examining energy allocation patterns and life history traits. Juvenile snails exposed to pyraclostrobin decreased feeding rate and increased apparent avoidance behaviors at environmentally relevant concentrations. In adults, we found that sublethal concentrations of pyraclostrobin did not affect reproductive output, however, there were significant effects on developmental endpoints with longer time to hatch and decreased hatching success in pyraclostrobin-exposed egg masses. Further, there were apparent differences in developmental effects depending on whether mothers were also exposed to pyraclostrobin suggesting this chemical can exert intergenerational effects. Pyraclostrobin also affected protein and carbohydrate content of eggs in mothers that were exposed to pyraclostrobin. Significant effects on macronutrient content of eggs occurred at lower concentrations than effects on gross endpoints such as hatching success and time to hatch suggesting potential value for these endpoints as early indicators of ecologically relevant stress. These results provide important insight into the effects of a common fungicide on important endpoints for organismal energetics and life history. Copyright © 2015 Elsevier Ltd. All rights reserved.

  15. EDF operational experience of primary circuit filter usage. Analysis of results and strategy for optimizing filtration and reducing solid wastes

    International Nuclear Information System (INIS)

    Mascarenhas, Darren; Moleiro, Edgar; Bancelin, Estelle; Bretelle, Jean-Luc

    2014-01-01

    Pleated fibreglass media filter cartridges are used throughout the auxiliary systems at nuclear power plants across the 58 reactors of EDF fleet. The main role of these filters is to remove suspended solids from coolant to prevent them accumulating in circuits or in equipments. In the primary circuit, these filters therefore limit the deposition of solids that are active or could become active if allowed to recirculate throughout the primary circuit, avoiding potential consequences such as an increase in dose rates, axial offset anomalies, demineralisers fouling, higher pressure losses in primary loop, and clogging of the primary pumps. Since 2008, a steady increase in the consumption of filters has been noticed, and therefore an increase in the amount of solid waste to treat. Preliminary studies have identified the primary circuit high-flow filters of the 1300/1450 MWe reactors as the main source of this increase. Not only has this stretched of solid waste containers production to the limit, as well as strained site resources and increased risks of operational errors during periods of frequent filter changes; it has also suggested that there is an underlying problem that could pose a serious risk to the primary circuit if untreated. Further studies have been carried out to identify more precisely the impact of possible causes, including increased quality surveillance of the filters, correlation of consumption data with the concentrations of various conditioning products and typical pollutants, and an impact analysis of events such as steam generator replacements or new practices like zinc injection. Work has been done with the filter manufacturer to improve their service lifetime and a simulation tool has been developed in order to understand and optimise filtration. We are also working with sites on creating good practices and avoiding bad ones. These actions should reduce the consumption in the short term while still assuring a high quality of filtration and

  16. Endpoint design for future renal denervation trials - Novel implications for a new definition of treatment response to renal denervation.

    Science.gov (United States)

    Lambert, Thomas; Nahler, Alexander; Rohla, Miklos; Reiter, Christian; Grund, Michael; Kammler, Jürgen; Blessberger, Hermann; Kypta, Alexander; Kellermair, Jörg; Schwarz, Stefan; Starnawski, Jennifer A; Lichtenauer, Michael; Weiss, Thomas W; Huber, Kurt; Steinwender, Clemens

    2016-10-01

    Defining an adequate endpoint for renal denervation trials represents a major challenge. A high inter-individual and intra-individual variability of blood pressure levels as well as a partial or total non-adherence on antihypertensive drugs hamper treatment evaluations after renal denervation. Blood pressure measurements at a single point in time as used as primary endpoint in most clinical trials on renal denervation, might not be sufficient to discriminate between patients who do or do not respond to renal denervation. We compared the traditional responder classification (defined as systolic 24-hour blood pressure reduction of -5mmHg six months after renal denervation) with a novel definition of an ideal respondership (based on a 24h blood pressure reduction at no point in time, one, or all follow-up timepoints). We were able to re-classify almost a quarter of patients. Blood pressure variability was substantial in patients traditionally defined as responders. On the other hand, our novel classification of an ideal respondership seems to be clinically superior in discriminating sustained from pseudo-response to renal denervation. Based on our observations, we recommend that the traditional response classification should be reconsidered and possibly strengthened by using a composite endpoint of 24h-BP reductions at different follow-up-visits. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  17. The primary circuit materials properties results analysis performed on archive material used in NPP V-1 and Kola NPP Units 1 and 2

    Energy Technology Data Exchange (ETDEWEB)

    Kupca, L.; Beno, P. [Nuclear Power Plants Research Institute Inc., Trnava (Slovakia)

    1997-04-01

    A very brief summary is provided of a primary circuit piping material properties analysis. The analysis was performed for the Bohunice V-1 reactor and the Kola-1 and -2 reactors. Assessment was performed on Bohunice V-1 archive materials and primary piping material cut from the Kola units after 100,000 hours of operation. Main research program tasks included analysis of mechanical properties, corrosion stability, and microstructural properties. Analysis results are not provided.

  18. Primary hydatid disease of the femur: unsuspected and incidental MRI findings with long-term curative results on medical treatment alone

    International Nuclear Information System (INIS)

    Poyanli, A.; Sencer, S.; Akan, K.; Poyanli, O.; Sayrak, H.

    2001-01-01

    This report describes the early magnetic resonance imaging (MRI) findings and long-term follow-up results of albendazole treatment in a 16-year-old girl with primary hydatid disease of the femur diagnosed incidentally during the course of a post-traumatic knee infection. As far as we know, this is the first report of the early MRI findings and long-term outcome of medical treatment in primary hydatid disease of the femur in this age group. (orig.)

  19. Primary hydatid disease of the femur: unsuspected and incidental MRI findings with long-term curative results on medical treatment alone

    Energy Technology Data Exchange (ETDEWEB)

    Poyanli, A.; Sencer, S. [Dept. of Radiology, Istanbul Faculty of Medicine (Turkey); Akan, K.; Poyanli, O. [Dept. of Orthopaedics and Traumatology, Goeztepe SSK Educational Hospital, Istanbul (Turkey); Sayrak, H. [Dept. of Pathology, Goeztepe SSK Educational Hospital, Istanbul (Turkey)

    2001-11-01

    This report describes the early magnetic resonance imaging (MRI) findings and long-term follow-up results of albendazole treatment in a 16-year-old girl with primary hydatid disease of the femur diagnosed incidentally during the course of a post-traumatic knee infection. As far as we know, this is the first report of the early MRI findings and long-term outcome of medical treatment in primary hydatid disease of the femur in this age group. (orig.)

  20. Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa.

    Science.gov (United States)

    Tapia, Milagritos D; Armah, George; Breiman, Robert F; Dallas, Michael J; Lewis, Kristen D C; Sow, Samba O; Rivers, Stephen B; Levine, Myron M; Laserson, Kayla F; Feikin, Daniel R; Victor, John C; Ciarlet, Max; Neuzil, Kathleen M; Steele, A Duncan

    2012-04-27

    The efficacy of the pentavalent rotavirus vaccine (PRV), RotaTeq(®), was evaluated in a double-blind, placebo-controlled, multicenter Phase III clinical trial conducted (April 2007-March 2009) in 3 low-income countries in Africa: Ghana, Kenya, and Mali. In total, 5468 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6, 10, and 14 weeks of age; concomitant administration with routine EPI vaccines, including OPV, was allowed. HIV-infected infants were not excluded. The primary endpoint, vaccine efficacy (VE) against severe-rotavirus gastroenteritis (RVGE), as measured by Vesikari scoring system (VSS, score ≥11), from ≥14 days following Dose 3 through a follow-up period of nearly 2 years in the combined 3 African countries, and secondary endpoints by total follow-up period have been previously reported. In this study, we report post hoc subgroup analyses on secondary endpoints of public health importance. VE against RVGE of any severity was 49.2% (95%CI: 29.9, 63.5) through the first year of life and 30.5% (95%CI: 16.7, 42.2) through the complete follow-up period. VE against severe-gastroenteritis of any etiology was 21.5% (95%CI: vaccine-contained G and P types (G1-G4, P1A[8]), (ii) non-vaccine G types (G8, G9, G10), and (iii) non-vaccine P types (P1B[4], P2A[6]) was 34.0% (95%CI:11.2, 51.2), 81.8% (95%CI:16.5, 98.0) and 40.7% (95%CI:8.4, 62.1), respectively. There was a trend towards higher VE with higher disease severity, although in some cases the numbers were small. In African countries with high under-5 mortality rates, PRV significantly reduced RVGE through nearly 2 years of follow-up; more modest reductions were observed against gastroenteritis of any etiology. PRV provides protection against severe-RVGE caused by diverse rotavirus genotypes, including those not contained in the vaccine. Copyright © 2012 Elsevier Ltd. All rights reserved.

  1. Comprehensive process model of clinical information interaction in primary care: results of a "best-fit" framework synthesis.

    Science.gov (United States)

    Veinot, Tiffany C; Senteio, Charles R; Hanauer, David; Lowery, Julie C

    2018-06-01

    To describe a new, comprehensive process model of clinical information interaction in primary care (Clinical Information Interaction Model, or CIIM) based on a systematic synthesis of published research. We used the "best fit" framework synthesis approach. Searches were performed in PubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, Library and Information Science Abstracts, Library, Information Science and Technology Abstracts, and Engineering Village. Two authors reviewed articles according to inclusion and exclusion criteria. Data abstraction and content analysis of 443 published papers were used to create a model in which every element was supported by empirical research. The CIIM documents how primary care clinicians interact with information as they make point-of-care clinical decisions. The model highlights 3 major process components: (1) context, (2) activity (usual and contingent), and (3) influence. Usual activities include information processing, source-user interaction, information evaluation, selection of information, information use, clinical reasoning, and clinical decisions. Clinician characteristics, patient behaviors, and other professionals influence the process. The CIIM depicts the complete process of information interaction, enabling a grasp of relationships previously difficult to discern. The CIIM suggests potentially helpful functionality for clinical decision support systems (CDSSs) to support primary care, including a greater focus on information processing and use. The CIIM also documents the role of influence in clinical information interaction; influencers may affect the success of CDSS implementations. The CIIM offers a new framework for achieving CDSS workflow integration and new directions for CDSS design that can support the work of diverse primary care clinicians.

  2. Why target sedentary adults in primary health care? Baseline results from the Waikato Heart, Health, and Activity Study.

    Science.gov (United States)

    Elley, C Raina; Kerse, Ngaire M; Arroll, Bruce

    2003-10-01

    The question of whether the public health issue of physical inactivity should be addressed in primary health care is a controversial matter. Baseline cross-sectional analysis of a physician-based physical activity intervention trial involving sedentary adults was undertaken within 42 rural and urban family practices in New Zealand to examine self-reported levels of physical activity and cardiovascular risk factors. A self-administered single question about physical activity was used to screen 40- to 79-year-old patients from waiting rooms for physical inactivity. The positive predictive value of the screening question was 81%. Participation rates for the study were high, including 74% of family physicians (n = 117) in the region. Eighty-eight percent of consecutive patients in the age group agreed to be screened and 46% were identified as sedentary. Of those eligible, 66% (n = 878) agreed to participate in a study involving a lifestyle intervention from their family physician. Blood pressure and BMI were significantly greater than that in the general population. There were high rates of hypertension (52%), diabetes (10.5%), obesity (43%), previous cardiovascular disease (19%), and risk factors for cardiovascular disease (93%). Decreasing total energy expenditure was associated with increasing cardiovascular risk (P = 0.001). Sedentary adults in primary care represent a high cardiovascular risk population. Screening for inactivity in primary care is effective and efficient. Two-thirds of sedentary adults agreed to receive a lifestyle intervention from their family physician.

  3. Mesoscale simulation of semiflexible chains. I. Endpoint distribution and chain dynamics

    Science.gov (United States)

    Groot, Robert D.

    2013-06-01

    The endpoint distribution and dynamics of semiflexible fibers are studied by numerical simulation. A brief overview is given over the analytical theory of flexible and semiflexible polymers. In particular, a closed expression is given for the relaxation spectrum of wormlike chains, which determines polymer diffusion and rheology. Next a simulation model for wormlike chains with full hydrodynamic interaction is described, and relations for the bending and torsion modulus are given. Two methods are introduced to include torsion stiffness into the model. The model is validated by simulating single chains in a heat bath, and comparing the endpoint distribution of the chains with established Monte Carlo results. It is concluded that torsion stiffness leads to a slightly shorter effective persistence length for a given bending stiffness. To further validate the simulation model, polymer diffusion is studied for fixed persistence length and varying polymer length N. The diffusion constant shows crossover from Rouse (D ∝ N-1) to reptation behaviour (D ∝ N-2). The terminal relaxation time obtained from the monomer displacement is consistent with the theory of wormlike chains. The probability for chain crossing has also been studied. This probability is so low that it does not influence the present results.

  4. HANFORD DOUBLE-SHELL TANK (DST) THERMAL and SEISMIC PROJECT-BUCKLING EVALUATION METHODS and RESULTS FOR THE PRIMARY TANKS

    International Nuclear Information System (INIS)

    Mackey, T.C.; Johnson, K.I.; Deibler, J.E.; Pilli, S.P.; Rinker, M.W.; Karri, N.K.

    2007-01-01

    This report documents a detailed buckling evaluation of the primary tanks in the Hanford double-shell waste tanks (DSTs), which is part of a comprehensive structural review for the Double-Shell Tank Integrity Project. This work also provides information on tank integrity that specifically responds to concerns raised by the Office of Environment, Safety, and Health (ES and H) Oversight (EH-22) during a review of work performed on the double-shell tank farms and the operation of the aging waste facility (AWF) primary tank ventilation system. The current buckling review focuses on the following tasks: (1) Evaluate the potential for progressive I-bolt failure and the appropriateness of the safety factors that were used for evaluating local and global buckling. The analysis will specifically answer the following questions: (a) Can the EH-22 scenario develop if the vacuum is limited to -6.6-inch water gage (w.g.) by a relief valve? (b) What is the appropriate factor of safety required to protect against buckling if the EH-22 scenario can develop? (c) What is the appropriate factor of safety required to protect against buckling if the EH-22 scenario cannot develop? (2) Develop influence functions to estimate the axial stresses in the primary tanks for all reasonable combinations of tank loads, based on detailed finite element analysis. The analysis must account for the variation in design details and operating conditions between the different DSTs. The analysis must also address the imperfection sensitivity of the primary tank to buckling. (3) Perform a detailed buckling analysis to determine the maximum allowable differential pressure for each of the DST primary tanks at the current specified limits on waste temperature, height, and specific gravity. Based on the I-bolt loads analysis and the small deformations that are predicted at the unfactored limits on vacuum and axial loads, it is very unlikely that the EH-22 scenario (i.e., progressive I-bolt failure leading to

  5. SpEnD: Linked Data SPARQL Endpoints Discovery Using Search Engines

    Science.gov (United States)

    Yumusak, Semih; Dogdu, Erdogan; Kodaz, Halife; Kamilaris, Andreas; Vandenbussche, Pierre-Yves

    In this study, a novel metacrawling method is proposed for discovering and monitoring linked data sources on the Web. We implemented the method in a prototype system, named SPARQL Endpoints Discovery (SpEnD). SpEnD starts with a "search keyword" discovery process for finding relevant keywords for the linked data domain and specifically SPARQL endpoints. Then, these search keywords are utilized to find linked data sources via popular search engines (Google, Bing, Yahoo, Yandex). By using this method, most of the currently listed SPARQL endpoints in existing endpoint repositories, as well as a significant number of new SPARQL endpoints, have been discovered. Finally, we have developed a new SPARQL endpoint crawler (SpEC) for crawling and link analysis.

  6. [Preliminary results of an anonymous internet-based reporting system for critical incidents in ambulatory primary care].

    Science.gov (United States)

    Brun, A

    2005-03-01

    To learn from errors is not always easy, especially if they happened to others! This paper describes the organization and management of a critical incident reporting system for primary care physicians in Switzerland and reports about the difficulties and experiences during the first 18 months since the start of the program. It seems to be particularly difficult to enhance the attentiveness of physicians for apparently harmless daily critical incidents and to motivate them to report it even in an anonymous reporting system. As incentives for more intensive participation there are the hope for comments on reported cases by other participants and the expectation that reported errors will be avoided by the readers.

  7. A Multilingual Approach to Analysing Standardized Test Results: Immigrant Primary School Children and the Role of Languages Spoken in a Bi-/Multilingual Community

    Science.gov (United States)

    De Angelis, Gessica

    2014-01-01

    The present study adopts a multilingual approach to analysing the standardized test results of primary school immigrant children living in the bi-/multilingual context of South Tyrol, Italy. The standardized test results are from the Invalsi test administered across Italy in 2009/2010. In South Tyrol, several languages are spoken on a daily basis…

  8. Impact of marital status on survival of gastric adenocarcinoma patients: Results from the Surveillance Epidemiology and End Results (SEER) Database

    OpenAIRE

    Qiu, Miaozhen; Yang, Dajun; Xu, Ruihua

    2016-01-01

    Marital status was found to be an independent prognostic factor for survival in various cancer types. In this study, we used the Surveillance, Epidemiology and End Results database to analyze the survival difference among different marital status in the United States. Gastric adenocarcinoma patients from 2004?2012 were enrolled for study. The 5-year cause specific survival (CSS) was our primary endpoint. Totally 29,074 eligible patients were identified. We found that more male patients were m...

  9. Current practice trends in allergy: results of a united states survey of otolaryngologists, allergist-immunologists, and primary care physicians.

    Science.gov (United States)

    Ryan, Matthew W; Marple, Bradley F; Leatherman, Bryan; Mims, J Whit; Fornadley, John; Veling, Maria; Lin, Sandra Y

    2014-10-01

    Clinical practices for the diagnosis and treatment of allergic disease evolve over time in response to a variety of forces. The techniques used by various physician specialties are not clearly defined and may vary from published descriptions or recommendations in the literature. This work is a Web-based survey enrolling 250 U.S. physicians in the following specialties: otolaryngology (ENT), allergy-immunology (A/I), and primary care (PCP). Respondents reported that skin-prick testing is the most common diagnostic testing method, followed by in vitro specific immunoglobulin E (IgE) testing. ENTs were more likely to use intradermal testing compared to other specialties (p = 0.0003 vs A/I; p 60). Significant use of home immunotherapy injections (defined as >10% of immunotherapy patients) ranged from 27% to 36% of physicians, with no statistically significant difference noted based upon specialty. PCPs reported greater use of sublingual immunotherapy (PCP, 68%; A/I, 45%; otolaryngology, 35%; A/I vs PCP, p = 0.005; ENT vs PCP p allergy testing and treatment methods are employed by U.S. physicians, with some differences noted based upon specialty. Home immunotherapy continues to be employed in allergy practices, and sublingual immunotherapy is a common form of delivery, especially in primary care practices. © 2014 ARS-AAOA, LLC.

  10. HANFORD DOUBLE SHELL TANK THERMAL AND SEISMIC PROJECT BUCKLING EVALUATION METHODS AND RESULTS FOR THE PRIMARY TANKS

    Energy Technology Data Exchange (ETDEWEB)

    MACKEY TC; JOHNSON KI; DEIBLER JE; PILLI SP; RINKER MW; KARRI NK

    2009-01-14

    This report documents a detailed buckling evaluation of the primary tanks in the Hanford double-shell waste tanks (DSTs), which is part of a comprehensive structural review for the Double-Shell Tank Integrity Project. This work also provides information on tank integrity that specifically responds to concerns raised by the Office of Environment, Safety, and Health (ES&H) Oversight (EH-22) during a review of work performed on the double-shell tank farms and the operation of the aging waste facility (AWF) primary tank ventilation system. The current buckling review focuses on the following tasks: (1) Evaluate the potential for progressive anchor bolt failure and the appropriateness of the safety factors that were used for evaluating local and global buckling. The analysis will specifically answer the following questions: (a) Can the EH-22 scenario develop if the vacuum is limited to -6.6-inch water gage (w.g.) by a relief valve? (b) What is the appropriate factor of safety required to protect against buckling if the EH-22 scenario can develop? (c) What is the appropriate factor of safety required to protect against buckling if the EH-22 scenario cannot develop? (2) Develop influence functions to estimate the axial stresses in the primary tanks for all reasonable combinations of tank loads based on detailed finite element analysis. The analysis must account for the variation in design details and operating conditions between the different DSTs. The analysis must also address the imperfection sensitivity of the primary tank to buckling. (3) Perform a detailed buckling analysis to determine the maximum allowable differential pressure for each of the DST primary tanks at the current specified limits on waste temperature, height, and specific gravity. Based on the concrete anchor bolt loads analysis and the small deformations that are predicted at the unfactored limits on vacuum and axial loads, it is very unlikely that the EH-22 scenario (i.e., progressive anchor bolt

  11. HANFORD DOUBLE-SHELL TANK THERMAL AND SEISMIC PROJECT-BUCKLING EVALUATION METHODS AND RESULTS FOR THE PRIMARY TANKS

    International Nuclear Information System (INIS)

    Mackey, T.C.; Johnson, K.I.; Deibler, J.E.; Pilli, S.P.; Rinker, M.W.; Karri, N.K.

    2009-01-01

    This report documents a detailed buckling evaluation of the primary tanks in the Hanford double-shell waste tanks (DSTs), which is part of a comprehensive structural review for the Double-Shell Tank Integrity Project. This work also provides information on tank integrity that specifically responds to concerns raised by the Office of Environment, Safety, and Health (ES and H) Oversight (EH-22) during a review of work performed on the double-shell tank farms and the operation of the aging waste facility (AWF) primary tank ventilation system. The current buckling review focuses on the following tasks: (1) Evaluate the potential for progressive anchor bolt failure and the appropriateness of the safety factors that were used for evaluating local and global buckling. The analysis will specifically answer the following questions: (a) Can the EH-22 scenario develop if the vacuum is limited to -6.6-inch water gage (w.g.) by a relief valve? (b) What is the appropriate factor of safety required to protect against buckling if the EH-22 scenario can develop? (c) What is the appropriate factor of safety required to protect against buckling if the EH-22 scenario cannot develop? (2) Develop influence functions to estimate the axial stresses in the primary tanks for all reasonable combinations of tank loads based on detailed finite element analysis. The analysis must account for the variation in design details and operating conditions between the different DSTs. The analysis must also address the imperfection sensitivity of the primary tank to buckling. (3) Perform a detailed buckling analysis to determine the maximum allowable differential pressure for each of the DST primary tanks at the current specified limits on waste temperature, height, and specific gravity. Based on the concrete anchor bolt loads analysis and the small deformations that are predicted at the unfactored limits on vacuum and axial loads, it is very unlikely that the EH-22 scenario (i.e., progressive anchor

  12. Sensitive endpoints in extended one-generation reproductive toxicity study versus two generation?

    DEFF Research Database (Denmark)

    Christiansen, Sofie

    . The protocol includes assessment of novel endpoints of concern and developmental landmarks such as anogenital distance, nipple retention (both sensitive endpoints for anti-androgenic effects in male offspring) and mammary gland development (sensitive endpoint for oestrogen action) and may also include...... during critical period of development in contrast to the parental generation. Retrospective analysis of available two-generation studies, however, indicate that the assessment included in the study of other endpoints in the male offspring such as histopathology of reproductive organs and semen quality...

  13. 21 CFR 314.510 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival...

    Science.gov (United States)

    2010-04-01

    ... Serious or Life-Threatening Illnesses § 314.510 Approval based on a surrogate endpoint or on an effect on... well-controlled. The applicant shall carry out any such studies with due diligence. ...

  14. Predicting ion exchange resins decontamination factors. Experiments on synthetic primary coolant containing Ni, Co and Ag and modeling results

    International Nuclear Information System (INIS)

    Bachet, Martin; Schneider, Hélène; Jauberty, Loïc; Windt, Laurent De; Dieuleveult, Caroline de; Tevissen, Etienne

    2014-01-01

    Experiments performed under chemical and flow conditions representative of pressurized water reactors (PWR) primary fluid purification by ion exchange resins (Amberlite IRN9882) are modeled with the OPTIPUR code, considering 1D reactive transport in the mixed-bed column with convective/dispersive transport between beads and electro-diffusive transport within the boundary film around the beads. The effectiveness of the purification in these dilute conditions is highly related to film mass transfer restrictions, which are accounted for by adjustment of a common mass transfer coefficient (MTC) on the experimental initial leakage or modeling of species diffusion through the bead film by the Nernst-Planck equation. A detailed analysis of the modeling against experimental data shows that the Nernst-Planck approach with no adjustable parameters performs as well as, or better, than the MTC approach, particularly to simulate the chromatographic elution of silver by nickel and the subsequent enrichment of the solution in the former metal. (author)

  15. PRIMARY ENDOPROSTHETIC REPLACEMENT OF THE ANOPHTHALMIC ORBIT IN PATIENTS WITH UVEAL MELANOMA: SIX-YEAR FOLLOW-UP RESULTS

    Directory of Open Access Journals (Sweden)

    A. A. Yarovoy

    2012-01-01

    Full Text Available A locomotor stump was formed in 36 patients (28 women and 8 men, by implanting an endoprosthesis for enucleation of the eyeball with uveal melanoma (UM. The indication for endoprosthesis implantation was no signs of extrabulbar growth. A modified 17–19 mm silicone implant covered with strips from a dura mater graft and medical mesh fabric was used as an orbital implant. The follow-up was 3 to 72 months (mean 32.5 months. All the patients achieved a satisfactory cosmetic effect. None patient was found to have a recurrent orbital tumor. Out of the complications, anterior implant surface denudation was noted in 4 patients. Two patients developed metastases. The absence of recurrent orbital UM at a 6-year follow-up enables primary endoprosthetic replacement of the orbit for UM to be regarded as a safe and reasonable method for patient cosmetic rehabilitation. 

  16. Comparison of Cardiovascular Risk Screening Methods and Mortality Data among Hungarian Primary Care Population: Preliminary Results of the First Government-Financed Managed Care Program.

    Science.gov (United States)

    Móczár, Csaba; Rurik, Imre

    2015-09-01

    Besides participation in the primary prevention, screening as secondary prevention is an important requirement for primary care services. The effect of this work is influenced by the characteristics of individual primary care practices and doctors' screening habits, as well as by the regulation of screening processes and available financial resources. Between 1999 and 2009, a managed care program was introduced and carried out in Hungary, financed by the government. This financial support and motivation gave the opportunity to increase the number of screenings. 4,462 patients of 40 primary care practices were screened on the basis of SCORE risk assessment. The results of the screening were compared on the basis of two groups of patients, namely: those who had been pre-screened (pre-screening method) for known risk factors in their medical history (smoking, BMI, age, family cardiovascular history), and those randomly screened. The authors also compared the mortality data of participating primary care practices with the regional and national data. The average score was significantly higher in the pre-screened group of patients, regardless of whether the risk factors were considered one by one or in combination. Mortality was significantly lower in the participating primary practices than had been expected on the basis of the national mortality data. This government-financed program was a big step forward to establish a proper screening method within Hungarian primary care. Performing cardiovascular screening of a selected target group is presumably more appropriate than screening within a randomly selected population. Both methods resulted in a visible improvement in regional mortality data, though it is very likely that with pre-screening a more cost-effective selection for screening may be obtained.

  17. New results form HST on fast, colimated outflows in dying stars - the primary mechanism for shaping planetary nebulae

    Science.gov (United States)

    Sahai, R.; Contreras, C.

    2003-01-01

    In this paper, we briefly describe the results from imaging surveys of young PNe and PPNe with HST, and then present new results from detailed kinematic studies of several prominent objects which support our hypothesis for shaping PNe.

  18. A comparison of expectations and impressions of ethical characteristics of dentists: results of a community primary care survey.

    Science.gov (United States)

    Reid, Kevin; Humeniuk, Katherine M; Hellyer, Joan Henriksen; Thorsteinsdottir, Bjorg; Tilburt, Jon C

    2014-08-01

    To better define potential challenges in dental professional ethics, the authors gathered data regarding patients' characterizations of an ideal dentist and compared them with their impressions of dentists in general. The authors invited 500 consecutively seen primary care patients at an academic medical center to participate in the study. Participants completed a 32-item survey assessing key domains of ethical characteristics of health care professionals: trustworthiness, honesty, beneficence, nonmaleficence, respect for autonomy, empathy, compassion, patience, courage, humility and dedication. The authors used the McNemar paired t test to compare respondents' ratings of ideal dentists with their ratings of dentists in general. Two hundred eight-five patients returned completed surveys, for a response rate of 57 percent. The authors found statistically significant differences between ideal and perceived characteristics in all but one domain. The area of greatest difference related to the domain of trustworthiness (that is, dentists should not "propose unnecessary treatments just so they can make money"). For this survey item, 98 percent of patients reported that it was very or extremely important, but only 57 percent of respondents moderately or strongly agreed that dentists in general were engaging in this practice (P dental profession and their actual impressions of dentists in general. Addressing these discrepancies may be crucial if dentistry is to continue to enjoy the public's trust.

  19. On the relationship between dynamic visual and auditory processing and literacy skills; results from a large primary-school study.

    Science.gov (United States)

    Talcott, Joel B; Witton, Caroline; Hebb, Gillian S; Stoodley, Catherine J; Westwood, Elizabeth A; France, Susan J; Hansen, Peter C; Stein, John F

    2002-01-01

    Three hundred and fifty randomly selected primary school children completed a psychometric and psychophysical test battery to ascertain relationships between reading ability and sensitivity to dynamic visual and auditory stimuli. The first analysis examined whether sensitivity to visual coherent motion and auditory frequency resolution differed between groups of children with different literacy and cognitive skills. For both tasks, a main effect of literacy group was found in the absence of a main effect for intelligence or an interaction between these factors. To assess the potential confounding effects of attention, a second analysis of the frequency discrimination data was conducted with performance on catch trials entered as a covariate. Significant effects for both the covariate and literacy skill was found, but again there was no main effect of intelligence, nor was there an interaction between intelligence and literacy skill. Regression analyses were conducted to determine the magnitude of the relationship between sensory and literacy skills in the entire sample. Both visual motion sensitivity and auditory sensitivity to frequency differences were robust predictors of children's literacy skills and their orthographic and phonological skills.

  20. Prevalence and control of high blood pressure in primary care: results from the German Metabolic and Cardiovascular Risk Study (GEMCAS).

    Science.gov (United States)

    Balijepalli, Chakrapani; Bramlage, Peter; Lösch, Christian; Zemmrich, Claudia; Humphries, Karin H; Moebus, Susanne

    2014-06-01

    Contemporary epidemiological data on blood pressure readings, hypertension prevalence and control in unselected patient populations covering a broad age range are scarce. The aim here is to report the prevalence of high blood pressure and to identify factors associated with blood pressure control in a large German primary care sample. We used data from the German Metabolic and Cardiovascular Risk Study including 35 869 patients aged 18-99 years. High blood pressure was defined as systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg or using antihypertensive therapy. Factors associated with blood pressure control among patients receiving antihypertensive therapy were examined using multiple logistic regressions to estimate odds ratios and 95% confidence intervals. The prevalence of high blood pressure, uncontrolled high blood pressure and untreated high blood pressure was 54.8%, 21.3% and 17.6%, respectively. Age >50 years (1.52; 1.40-1.65), male sex (1.30; 1.20-1.41), elevated waist circumference (1.55; 1.45-1.65), high cholesterol (1.24; 1.16-1.33), high triglycerides (1.11; 1.04-1.19) and concomitant diabetes (1.29; 1.20-1.40) were independently associated with uncontrolled high blood pressure. In a majority of patients we observed hypertension despite treatment for high blood pressures. Studies examining the reasons for treatment failure are highly warranted.

  1. Drug adherence in treatment resistant and in controlled hypertension-Results from the Swedish Primary Care Cardiovascular Database (SPCCD).

    Science.gov (United States)

    Holmqvist, Lina; Boström, Kristina Bengtsson; Kahan, Thomas; Schiöler, Linus; Qvarnström, Miriam; Wettermark, Björn; Hjerpe, Per; Hasselström, Jan; Manhem, Karin

    2018-03-01

    To assess drug adherence in patients treated with ≥3 antihypertensive drug classes, with both controlled and uncontrolled blood pressure and describe associated factors for nonadherence. Patients with hypertension, without cardiovascular comorbidity, aged >30 years treated with ≥3 antihypertensive drug classes were followed for 2 years. Both patients with treatment resistant hypertension (TRH) and patients with controlled hypertension were included. Clinical data were derived from a primary care database. Pharmacy refill data from the Swedish Prescribed drug registry was used to calculate proportion of days covered (PDC). Patients with a PDC level ≥ 80% were included. We found 5846 patients treated ≥3 antihypertensive drug classes, 3508 with TRH (blood pressure ≥ 140/90), and 2338 with controlled blood pressure (drug therapy had similar decline in adherence over time regardless of initial blood pressure control. Diabetes was associated with better adherence, which may imply that the structured caregiving of these patients enhances antihypertensive drug treatment. Copyright © 2018 John Wiley & Sons, Ltd.

  2. A randomized double-blind phase III study of nimorazole as a hypoxic radiosensitizer of primary radiotherapy in supraglottic larynx and pharynx carcinoma. Results of the Danish Head and Neck Cancer Study (DAHANCA) Protocol 5-85

    DEFF Research Database (Denmark)

    Overgaard, J.; Hansen, H.S.; Overgaard, M.

    1998-01-01

    PURPOSE: A multicenter randomized and balanced double-blind trial with the objective of assessing the efficacy and tolerance of nimorazole given as a hypoxic radiosensitizer in conjunction with primary radiotherapy of invasive carcinoma of the supraglottic larynx and pharynx. PATIENTS AND TREATMENT...... for the end-points of final loco-regional control (including surgical salvage) and cancer-related deaths (52 versus 41%, P = 0.002). This trend was also found in the overall survival but to a lesser, non-significant extent (26 versus 16%, 10-year actuarial values, P = 0.32). Cox multivariate regression...... of dying from cancer. The compliance to radiotherapy was good and 98% of the patients received the planned dose. Late radiation-related morbidity was observed in 10% of the patients, irrespective of nimorazole treatment. Drug-related side-effects were minor and tolerable with transient nausea and vomiting...

  3. Radiological impacts analysis with use of new endpoint as complementary safety indicators

    International Nuclear Information System (INIS)

    Peralta Vital, J.L.; Gil Castillo, R.; Fleitas Estevez, G.G.; Olivera Acosta, J.

    2015-01-01

    The paper shows the new safety indicators on risk assessment (safety assessment) to radioactive waste environmental management implementation (concentrations and fluxes of naturally occurring radioactive materials (NORM)). The endpoint obtained, allow the best analysis of the radiological impact associated to radioactive waste isolation system. The common safety indicators for safety assessment purpose, dose and risk, are very time dependent, increasing the uncertainties in the results for long term assessment. The complementary and new proposed endpoints are more stable and they are not affected by changes in the critical group, pathways, etc. The NORM values on facility site were obtained as result of national surveys, the natural concentrations of U, Ra, Th, K has been associated with the variation of the lithologies in 3 geographical areas of the Country (Occidental, Central and Oriental). The results obtained are related with the safety assessment topics and allowed to apply the new complementary safety indicators, by comparisons between the natural concentrations and fluxes on site and its calculated values for the conceptual repository design. In order to normalize the concentration results, the analysis was realized adopting the criteria of the Repository Equivalent Rock Volume (RERV). The preliminary comparison showed that the calculated concentrations and fluxes in the Cuban conceptual radioactive waste repository are not higher than the natural values in the host rock. According to the application of new safety indicators, the reference disposal facility does not increase the natural activity concentration and fluxes in the environment. In order to implement these new safety indicator it has been used the current 226 Ra inventory of the Repository and the 226 Ra as natural concentration on the site. (authors)

  4. How "humane" is your endpoint? Refining the science-driven approach for termination of animal studies of chronic infection.

    OpenAIRE

    Nuno H Franco; Margarida Correia-Neves; I Anna S Olsson

    2012-01-01

    Public concern on issues such as animal welfare or the scientific validity and clinical value of animal research is growing, resulting in increasing regulatory demands for animal research. Abiding to the most stringent animal welfare standards, while having scientific objectives as the main priority, is often challenging. To do so, endpoints of studies involving severe, progressive diseases need to be established considering how early in the disease process the scientific objectives can be ac...

  5. Is Doubling of Serum Creatinine a Valid Clinical 'Hard' Endpoint in Clinical Nephrology Trials?

    NARCIS (Netherlands)

    Lambers Heerspink, H. J.; Perkovic, V.; de Zeeuw, D.

    2011-01-01

    The composite of end stage renal disease (ESRD), doubling of serum creatinine and (renal) death, is a frequently used endpoint in randomized clinical trials in nephrology. Doubling of serum creatinine is a well-accepted part of this endpoint because a doubling of serum creatinine reflects a large

  6. Right-handed currents at B→ K l+l− kinematic endpoint

    Indian Academy of Sciences (India)

    2017-10-09

    Oct 9, 2017 ... The recent LHCb measured values of these observables are used to conclude an evidence of right-handed currents at the kinematic endpoint of this decay mode. As the conclusion is drawn at the maximum dilepton invariant mass square ( q 2 ) kinematic endpoint, it relies only on heavy quark symmetries ...

  7. Restoration for the future: Setting endpoints and targets and selecting indicators of progress and success

    Science.gov (United States)

    Daniel C. Dey; Callie Jo Schweitzer; John M. Kabrick

    2014-01-01

    Setting endpoints and targets in forest restoration is a complicated task that is best accomplished in cooperative partnerships that account for the ecology of the system, production of desired ecosystem goods and services, economics and well-being of society, and future environments. Clearly written and quantitative endpoints and intermediary targets need to be...

  8. Restoration for the future: endpoints, targets, and indicators of progress and success

    Science.gov (United States)

    Daniel C. Dey; Callie Jo. Schweitzer

    2014-01-01

    Setting endpoints and targets in forest restoration is a complicated task that is best accomplished in cooperative partnerships that account for the ecology of the system, production of desired ecosystem goods and services, economics and well-being of society, and future environments. Clearly described and quantitative endpoints and intermediary targets are needed to...

  9. Prospective capillaroscopy-based study on transition from primary to secondary Raynaud’s phenomenon: preliminary results

    Directory of Open Access Journals (Sweden)

    E. Bernero

    2013-10-01

    Full Text Available The objective of this prospective study was to investigate the transition from primary (PRP to secondary (SRP Raynaud’s phenomenon (RP, in a large cohort of patients affected by isolated RP. A total of 2065 patients with RP were investigated by clinical interview, laboratory examinations, and nailfold videocapillaroscopy (NVC. Patients with negative NVC at first visit were yearly followed to monitor either the appearance of specific morphological alterations at NVC, or clinical manifestations of an underlying disease. Capillary abnormalities at NVC were scored, as well as the qualitative patterns of microangiopathy (Early, Active and Late. NVC was found negative at first visit in 1500 subjects; among them, 412 patients were evaluable and they were followed for a mean time of 5±4 years (range 2-13 years. Sixty-eight patients (16% achieved a diagnosis of SRP during follow-up, showing normal or not specific capillary alterations at NVC 4% of patients (the diagnosis was undifferentiated connective tissue diseases, Early scleroderma-pattern 57%, Active scleroderma-pattern 7%, Late scleroderma-pattern 12%, and scleroderma-like pattern 18% of patients. The time of transition from normal/not specific capillary alterations to Early scleroderma-pattern was 4.4±3.8 years. Enlarged capillaries (diameter between 20 and 50 microns and mild reduction of capillary density were found the more frequent markers at first NVC visit in patients who progressed to a scleroderma pattern (P=0.01. This study demonstrates in a large cohort, that almost 16% of patients initially diagnosed as affected by RP with negative NVC may transit to SRP during a mean follow-up of 4.4 years. PRP patients showing major notspecific alterations of nailfold capillaries at first NVC should be strictly monitored at least once a year since at higher risk of transition to SRP.

  10. Determinants of use of the bronchodilator test in primary and secondary care: results of a national survey in Spain.

    Science.gov (United States)

    Lopez-Campos, Jose Luis; Soriano, Joan B; Calle, Myriam

    2016-03-01

    A recent study evaluated the use of spirometry in primary (PC) and secondary care (SC) in Spain. In the present study, we aimed to analyze the determinants of use of the bronchodilator test (BDT) with a special emphasis in the type of drugs used, waiting times and positive test criteria followed. Cross-sectional trial surveying 605 PC and 200 SC centers in Spain. Regarding the BDT, variables collected were: name of the drugs available for the BDT, name of the drug normally used, number of inhalations, waiting time for the second spirometry, staff involved and criteria used for a positive test. Adherence to actual guidelines according to five quality criteria was evaluated. Although a range of short-acting bronchodilators were used, only 25.9% of centers used a correct dose. The waiting time was correct in 63.7% and 72.8% of PC and SC, respectively (P = 0.023). A threshold higher than 12% and 200 mL to consider a positive test was fulfilled in 55.8% and 52.8% of PC and SC, respectively. Altogether, only 7.6% of PC and 6.0% of SC fulfilled all five quality criteria. Factors identified to be associated with this fulfillment were the number of spirometries per week, not being conducted by a nurse, periodical retraining, training for interpreting and daily calibration. The present study identifies determinants of the performance of the BDT in Spain identifying strengths and weaknesses. Health managers should use this information to improve the quality of spirometries in chronic respiratory patients. © 2014 John Wiley & Sons Ltd.

  11. Radiation therapy of primary extranodal Non-Hodgkin's lymphoma of head and neck. Results of a prospective multicenter study

    International Nuclear Information System (INIS)

    Hoederath, A.; Sack, H.; Stuschke, M.; Lampka, E.

    1996-01-01

    Between January 1986 and August 1993, 63 patients with primary extranodal Non-Hodgkin lymphoma of head and neck region, stages IE and IIE were treated with radiotherapy. The histological classification followed the Kiel classification, staging the Ann Arbor classification. Patient characteristics: 33 Male, 30 female; age 18 to 84 years; tumor localisation: Tonsils 26, nasopharynx 7, oropharynx 8, paranasal sinus 11, salivary glands 7, floor of mouth/gingiva 3, larynx 1. Mean follow-up is 74 months. Low-grade lymphoma in stages I and II CS were treated with definitive radiation therapy according to the concepts of epithelial tumors of the same localisation (target volume and technique).The adjuvant dose was 30 Gy and in the tumor volume 40 Gy, 2 Gy daily. 28 patients were registered, 18 in stage I and 10 in stage II. High-grade lymphoma were treated with definitive radiation therapy according to the concepts of epithelial tumors of the same localisation, too. The dose was 40 respectively 50 Gy, followed by 4 course of adjuvant chemotherapy with CHOP. Thirty-five patients were enrolled, of whom only 10 received chemotherapy. The overall 5-year survical rates were for low-grade 67% and for high grade lymphoma 88%. The corresponding relapse-free survival rates were 54/68%, respectively. Only 1 patient failed within the irradiated target volume. Recurrences occurred at sites distant to the irradiated volume in nodal and extranodal regions. Prognosis was influenced by histologic grade. Significant trends were not observed for other potential pretreatment parameters (age, stage, localisation, bulk). (orig./MG) [de

  12. Investigation of allergenicity of some cosmetic mixtures by using ex vivo local lymph node assay-BrdU endpoints.

    Science.gov (United States)

    Ulker, Ozge Cemiloglu; Kaymak, Yesim; Karakaya, Asuman

    2014-01-01

    Balsam of Peru and fragrance mix are commonly used in cosmetic products. Allergy to fragrance is the most common cause of cosmetic contact dermatitis. In the present study, ex vivo local lymph node assay-5-bromo-2'-deoxyuridine (LLNA-BrdU) was used to evaluate the dermal sensitization potential of these cosmetic mixtures. The stimulation index values and estimated concentration (EC3) values were calculated and the potency classification was found for each mixture. At the same time, in order to measure the irritant effect without having to use additional animals, a combination of ex vivo LLNA-BrdU and the irritancy assay was conducted. Th1 [interleukin (IL)-2, interferon-γ] and Th2 cytokine (IL-4, IL-5) releases from lymph node cell culture were investigated as non-radioactive endpoints. According to the results of ex vivo LLNA-BrdU assays, EC3 values were found to be 3.09% (moderate) for balsam of Peru and 4.44% (moderate) for fragrance mix. Cytokine analysis results indicate that both Th1 and Th2 cytokines are involved in the regulation of murine contact allergy and can be considered as useful endpoints. In conclusion, according to our results, fragrance mix and balsam of Peru can be considered as moderate sensitizers; however, in high concentrations, both of them have irritation properties. The cytokines investigated can be considered as the endpoints of the ex vivo LLNA-BrdU assay. © 2014 S. Karger AG, Basel.

  13. OPERA models for predicting physicochemical properties and environmental fate endpoints.

    Science.gov (United States)

    Mansouri, Kamel; Grulke, Chris M; Judson, Richard S; Williams, Antony J

    2018-03-08

    The collection of chemical structure information and associated experimental data for quantitative structure-activity/property relationship (QSAR/QSPR) modeling is facilitated by an increasing number of public databases containing large amounts of useful data. However, the performance of QSAR models highly depends on the quality of the data and modeling methodology used. This study aims to develop robust QSAR/QSPR models for chemical properties of environmental interest that can be used for regulatory purposes. This study primarily uses data from the publicly available PHYSPROP database consisting of a set of 13 common physicochemical and environmental fate properties. These datasets have undergone extensive curation using an automated workflow to select only high-quality data, and the chemical structures were standardized prior to calculation of the molecular descriptors. The modeling procedure was developed based on the five Organization for Economic Cooperation and Development (OECD) principles for QSAR models. A weighted k-nearest neighbor approach was adopted using a minimum number of required descriptors calculated using PaDEL, an open-source software. The genetic algorithms selected only the most pertinent and mechanistically interpretable descriptors (2-15, with an average of 11 descriptors). The sizes of the modeled datasets varied from 150 chemicals for biodegradability half-life to 14,050 chemicals for logP, with an average of 3222 chemicals across all endpoints. The optimal models were built on randomly selected training sets (75%) and validated using fivefold cross-validation (CV) and test sets (25%). The CV Q 2 of the models varied from 0.72 to 0.95, with an average of 0.86 and an R 2 test value from 0.71 to 0.96, with an average of 0.82. Modeling and performance details are described in QSAR model reporting format and were validated by the European Commission's Joint Research Center to be OECD compliant. All models are freely available as an open

  14. Defining the end-point of mastication: A conceptual model.

    Science.gov (United States)

    Gray-Stuart, Eli M; Jones, Jim R; Bronlund, John E

    2017-10-01

    properties define the end-point texture and enduring sensory perception of the food. © 2017 Wiley Periodicals, Inc.

  15. Endpoints and cutpoints in head and neck oncology trials: methodical background, challenges, current practice and perspectives.

    Science.gov (United States)

    Hezel, Marcus; von Usslar, Kathrin; Kurzweg, Thiemo; Lörincz, Balazs B; Knecht, Rainald

    2016-04-01

    This article reviews the methodical and statistical basics of designing a trial, with a special focus on the process of defining and choosing endpoints and cutpoints as the foundations of clinical research, and ultimately that of evidence-based medicine. There has been a significant progress in the treatment of head and neck cancer in the past few decades. Currently available treatment options can have a variety of different goals, depending e.g. on tumor stage, among other factors. The outcome of a specific treatment in clinical trials is measured using endpoints. Besides classical endpoints, such as overall survival or organ preservation, other endpoints like quality of life are becoming increasingly important in designing and conducting a trial. The present work is based on electronic research and focuses on the solid methodical and statistical basics of a clinical trial, on the structure of study designs and on the presentation of various endpoints.

  16. Lethal and sublethal endpoints observed for Artemia exposed to two reference toxicants and an ecotoxicological concern organic compound.

    Science.gov (United States)

    Manfra, Loredana; Canepa, Sara; Piazza, Veronica; Faimali, Marco

    2016-01-01

    Swimming speed alteration and mortality assays with the marine crustacean Artemia franciscana were carried out. EC50 and LC50 values after 24-48h exposures were calculated for two reference toxicants, copper sulphate pentahydrate (CuSO4·5H2O) and Sodium Dodecyl Sulphate (SDS), and an ecotoxicological concern organic compound, Diethylene Glycol (DEG). Different end-points have been evaluated, in order to point out their sensitivity levels. The swimming speed alteration (SSA) was compared to mortality values and also to the hatching rate inhibition (literature data). SSA resulted to be more sensitive than the mortality and with a sensitivity comparable to (or even higher than) the hatching rate endpoint. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. QED contribution to the color-singlet J/ψ production in Υ decay near the endpoint

    International Nuclear Information System (INIS)

    Liu Xiaohui

    2010-01-01

    A recent study indicates that the α 2 α s 2 order QED processes of Υ→J/ψ+X decay are compatible with those of QCD processes. However, in the endpoint region, the nonrelativistic QED calculation breaks down since the collinear degrees of freedom are missing under the framework of this effective theory. In this paper we apply the soft-collinear effective theory (SCET) to study the color-singlet QED process at the kinematic limit. Within this approach we are able to sum the kinematic logarithms by running operators using the renormalization group equations of soft-collinear effective theory, which will lead to a dramatic change in the momentum distribution near the endpoint and the spectrum shape consistent with the experimental results.

  18. Augmentation of spelling therapy with transcranial direct current stimulation in primary progressive aphasia: Preliminary results and challenges.

    Science.gov (United States)

    Tsapkini, Kyrana; Frangakis, Constantine; Gomez, Yessenia; Davis, Cameron; Hillis, Argye E

    Primary progressive aphasia (PPA) is a neurodegenerative disease that primarily affects language functions and often begins in the fifth or sixth decade of life. The devastating effects on work and family life call for the investigation of treatment alternatives. In this article, we present new data indicating that neuromodulatory treatment, using transcranial direct current stimulation (tDCS) combined with a spelling intervention, shows some promise for maintaining or even improving language, at least temporarily, in PPA. The main aim of the present article is to determine whether tDCS plus spelling intervention is more effective than spelling intervention alone in treating written language in PPA. We also asked whether the effects of tDCS are sustained longer than the effects of spelling intervention alone. We present data from six PPA participants who underwent anodal tDCS or sham plus spelling intervention in a within-subject crossover design. Each stimulation condition lasted 3 weeks or a total of 15 sessions with a 2-month interval in between. Participants were evaluated on treatment tasks as well as on other language and cognitive tasks at 2-week and 2-month follow-up intervals after each stimulation condition. All participants showed improvement in spelling (with sham or tDCS). There was no difference in the treated items between the two conditions. There was, however, consistent and significant improvement for untrained items only in the tDCS plus spelling intervention condition. Furthermore, the improvement lasted longer in the tDCS plus spelling intervention condition compared to sham plus spelling intervention condition. Neuromodulation with tDCS offers promise as a means of augmenting language therapy to improve written language function at least temporarily in PPA. The consistent finding of generalisation of treatment benefits to untreated items and the superior sustainability of treatment effects with tDCS justifies further investigations. However

  19. Comparison endpoint study of process plasma and secondary electron beam exciter optical emission spectroscopy

    Energy Technology Data Exchange (ETDEWEB)

    Stephan Thamban, P. L.; Yun, Stuart; Padron-Wells, Gabriel; Hosch, Jimmy W.; Goeckner, Matthew J. [Department of Mechanical Engineering, University of Texas at Dallas, 800W Campbell Road, Richardson, Texas 75080 (United States); Department of Electrical Engineering, University of Texas at Dallas, 800W Campbell Road, Richardson, Texas 75080 (United States); Verity Instruments, Inc., 2901 Eisenhower Street, Carrollton, Texas 75007 (United States); Department of Mathematical Sciences, University of Texas at Dallas, 800 W Campbell Road, Richardson, Texas 75080 (United States)

    2012-11-15

    Traditionally process plasmas are often studied and monitored by optical emission spectroscopy. Here, the authors compare experimental measurements from a secondary electron beam excitation and direct process plasma excitation to discuss and illustrate its distinctiveness in the study of process plasmas. They present results that show excitations of etch process effluents in a SF{sub 6} discharge and endpoint detection capabilities in dark plasma process conditions. In SF{sub 6} discharges, a band around 300 nm, not visible in process emission, is observed and it can serve as a good indicator of etch product emission during polysilicon etches. Based on prior work reported in literature the authors believe this band is due to SiF{sub 4} gas phase species.

  20. Determination of the Acidity of Oils Using Paraformaldehyde as a Thermometric End-Point Indicator

    Directory of Open Access Journals (Sweden)

    Carneiro Mário J. D.

    2002-01-01

    Full Text Available The determination of the acidity of oils by catalytic thermometric titrimetry using paraformaldehyde as the thermometric end-point indicator was investigated. The sample solvent was a 1:1 (v/v mixture of toluene and 2-propanol and the titrant was 0.1 mol L-1 aqueous sodium hydroxide. Paraformaldehyde, being insoluble in the sample solvent, does not present the inconvenience of other indicators that change the properties of the solvent due to composition changes. The titration can therefore be done effectively in the same medium as the standard potentiometric and visual titration methods. The results of the application of the method to both non-refined and refined oils are presented herein. The proposed method has advantages in relation to the potentiometric method in terms of speed and simplicity.

  1. End-Point Contact Force Control with Quantitative Feedback Theory for Mobile Robots

    Directory of Open Access Journals (Sweden)

    Shuhuan Wen

    2012-12-01

    Full Text Available Robot force control is an important issue for intelligent mobile robotics. The end-point stiffness of a robot is a key and open problem in the research community. The control strategies are mostly dependent on both the specifications of the task and the environment of the robot. Due to the limited stiffness of the end-effector, we may adopt inherent torque to feedback the oscillations of the controlled force. This paper proposes an effective control strategy which contains a controller using quantitative feedback theory. The nested loop controllers take into account the physical limitation of the system's inner variables and harmful interference. The biggest advantage of the method is its simplicity in both the design process and the implementation of the control algorithm in engineering practice. Taking the one-link manipulator as an example, numerical experiments are carried out to verify the proposed control method. The results show the satisfactory performance.

  2. Patient-reported outcomes in insomnia: development of a conceptual framework and endpoint model.

    Science.gov (United States)

    Kleinman, Leah; Buysse, Daniel J; Harding, Gale; Lichstein, Kenneth; Kalsekar, Anupama; Roth, Thomas

    2013-01-01

    This article describes qualitative research conducted with patients with clinical diagnoses of insomnia and focuses on the development of a conceptual framework and endpoint model that identifies a hierarchy and interrelationships of potential outcomes in insomnia research. Focus groups were convened to discuss how patients experience insomnia and to generate items for patient-reported questionnaires on insomnia and associated daytime consequences. Results for the focus group produced two conceptual frameworks: one for sleep and one for daytime impairment. Each conceptual framework consists of hypothesized domains and items in each domain based on patient language taken from the focus group. These item pools may ultimately serve as a basis to develop new questionnaires to assess insomnia.

  3. Studies on potassium chlorate as a primary oxidimetric reagent.

    Science.gov (United States)

    Murty, C R; Rao, G G

    1972-01-01

    Conditions have been established for the use of potassium chlorate as a primary oxidizing agent in the direct titration of vanadium(III), tin(II) and titanium(III) with visual or potentiometric end-points.

  4. Treatment results in localized primary gastric lymphoma: data of patients registered within the German multicenter study (GIT NHL 02/96).

    Science.gov (United States)

    Koch, Peter; Probst, Andreas; Berdel, Wolfgang E; Willich, Normann A; Reinartz, Gabriele; Brockmann, Jens; Liersch, Rüdiger; del Valle, Francisco; Clasen, Hermann; Hirt, Carsten; Breitsprecher, Regine; Schmits, Rudolf; Freund, Mathias; Fietkau, Rainer; Ketterer, Peter; Freitag, Eva-Maria; Hinkelbein, Margit; Heinecke, Achim; Parwaresch, Reza; Tiemann, Markus

    2005-10-01

    In the prospective study 02/96 on primary GI lymphoma, we have collected data on histology, clinical features, and treatment results. In particular, in stages I and II localized primary gastric lymphoma (PGL), our objectives were to reduce treatment intensity and to confirm our hypothesis from study 01/92, which maintained that an organ-preserving approach is not inferior to primary surgery. Patients receiving radiotherapy and/or chemotherapy were stratified for histologic grade, stage, and whether surgery had been carried out or not (as decided by each participating center). Patients with aggressive PGL received six cycles of CHOP-14 (cyclophosphamide, doxorubicin, vincristine, and prednisone) followed by involved-field radiotherapy (40 Gy). Patients with indolent PGL (including patients experiencing treatment failure with antibiotic therapy for Helicobacter pylori) were treated with extended-field radiotherapy. The volume depended on stage. The irradiation dose was 30 Gy, followed by a boost of 10 Gy (the latter omitted after complete resection) to the tumor region. Seven hundred forty-seven patients were accrued. Of these patients, 393 with localized PGL were treated with radiotherapy and/or chemotherapy only or additional surgery between December 1996 and December 2003. The survival rate at 42 months for patients treated with surgery was 86% compared with 91.0% for patients without surgery. In this nonrandomized study (02/96), we reproduced the previous results of study 01/92 showing no disadvantage for an organ-preserving treatment. Therefore, primary stomach resection should be questioned.

  5. A conscious mouse model of gastric ileus using clinically relevant endpoints

    Directory of Open Access Journals (Sweden)

    Shao Yuanlin

    2005-06-01

    Full Text Available Abstract Background Gastric ileus is an unsolved clinical problem and current treatment is limited to supportive measures. Models of ileus using anesthetized animals, muscle strips or isolated smooth muscle cells do not adequately reproduce the clinical situation. Thus, previous studies using these techniques have not led to a clear understanding of the pathophysiology of ileus. The feasibility of using food intake and fecal output as simple, clinically relevant endpoints for monitoring ileus in a conscious mouse model was evaluated by assessing the severity and time course of various insults known to cause ileus. Methods Delayed food intake and fecal output associated with ileus was monitored after intraperitoneal injection of endotoxin, laparotomy with bowel manipulation, thermal injury or cerulein induced acute pancreatitis. The correlation of decreased food intake after endotoxin injection with gastric ileus was validated by measuring gastric emptying. The effect of endotoxin on general activity level and feeding behavior was also determined. Small bowel transit was measured using a phenol red marker. Results Each insult resulted in a transient and comparable decrease in food intake and fecal output consistent with the clinical picture of ileus. The endpoints were highly sensitive to small changes in low doses of endotoxin, the extent of bowel manipulation, and cerulein dose. The delay in food intake directly correlated with delayed gastric emptying. Changes in general activity and feeding behavior were insufficient to explain decreased food intake. Intestinal transit remained unchanged at the times measured. Conclusion Food intake and fecal output are sensitive markers of gastric dysfunction in four experimental models of ileus. In the mouse, delayed gastric emptying appears to be the major cause of the anorexic effect associated with ileus. Gastric dysfunction is more important than small bowel dysfunction in this model. Recovery of

  6. Biological and chemical tests of contaminated soils to determine bioavailability and environmentally acceptable endpoints (EAE)

    International Nuclear Information System (INIS)

    Montgomery, C.R.; Menzie, C.A.; Pauwells, S.J.

    1995-01-01

    The understanding of the concept of bioavailability of soil contaminants to receptors and its use in supporting the development of EAE is growing but still incomplete. Nonetheless, there is increased awareness of the importance of such data to determine acceptable cleanup levels and achieve timely site closures. This presentation discusses a framework for biological and chemical testing of contaminated soils developed as part of a Gas Research Institute (GRI) project entitled ''Environmentally Acceptable Endpoints in Soil Using a Risk Based Approach to Contaminated Site Management Based on Bioavailability of Chemicals in Soil.'' The presentation reviews the GRI program, and summarizes the findings of the biological and chemical testing section published in the GRI report. The three primary components of the presentation are: (1) defining the concept of bioavailability within the existing risk assessment paradigm, (2) assessing the usefulness of the existing tests to measure bioavailability and test frameworks used to interpret these measurements, and (3) suggesting how a small selection of relevant tests could be incorporated into a flexible testing scheme for soils to address this issue

  7. Measuring titratable alkalinity by single versus double endpoint titration: An evaluation in two cyprinodont species and implications for characterizing net H+ flux in aquatic organisms.

    Science.gov (United States)

    Brix, Kevin V; Wood, Chris M; Grosell, Martin

    2013-01-01

    In this study, Na(+) uptake and acid-base balance in the euryhaline pupfish Cyprinodon variegatus variegatus were characterized when fish were exposed to pH 4.5 freshwater (7mM Na(+)). Similar to the related cyprinodont, Fundulus heteroclitus, Na(+) uptake was significantly inhibited when exposed to low pH water. However, it initially appeared that C. v. variegatus increased apparent net acid excretion at low pH relative to circumneutral pH. This result is opposite to previous observations for F. heteroclitus under similar conditions where fish were observed to switch from apparent net H(+) excretion at circumneutral pH to apparent net H(+) uptake at low pH. Further investigation revealed disparate observations between these studies were the result of using double endpoint titrations to measure titratable alkalinity fluxes in the current study, while the earlier study utilized single endpoint titrations to measure these fluxes (i.e.,. Cyprinodon acid-base transport is qualitatively similar to Fundulus when characterized using single endpoint titrations). This led to a comparative investigation of these two methods. We hypothesized that either the single endpoint methodology was being influenced by a change in the buffer capacity of the water (e.g., mucus being released by the fish) at low pH, or the double endpoint methodology was not properly accounting for ammonia flux by the fish. A series of follow-up experiments indicated that buffer capacity of the water did not change significantly, that excretion of protein (a surrogate for mucus) was actually reduced at low pH, and that the double endpoint methodology does not properly account for NH(3) excretion by fish under low pH conditions. As a result, it overestimates net H(+) excretion during low pH exposure. After applying the maximum possible correction for this error (i.e., assuming that all ammonia is excreted as NH(3)), the double endpoint methodology indicates that net H(+) transport was reduced to

  8. Availability of herbal medicines and medicinal plants in the primary health facilities of the state of São Paulo, Southeast Brazil: results from the National Program for Access and Quality Improvement in Primary Care.

    Science.gov (United States)

    Caccia-Bava, Maria do Carmo Gullaci Guimarães; Bertoni, Bianca Waléria; Pereira, Ana Maria Soares; Martinez, Edson Zangiacomi

    2017-05-01

    This study aims to describe the availability of herbal medicines and medicinal plants in the primary care facilities in the state of São Paulo, Southeast Brazil, from the results of the first cycle of the National Program for Access and Quality Improvement in Primary Care (PMAQ). The PMAQ uses a national cross-sectional multicenter design, with data from 4,249 health facilities distributed among 645 municipalities of the state of São Paulo. Of these facilities, 467 (11%) had herbal medicines and/or medicinal plants. Among the 645 municipalities, 104 (16.1%) had at least one health facility that provided these drugs. We observed that the availability of herbal medicines is greater in larger cities with better social and economic conditions. Furthermore, we found that use of industrialized herbal medicines prevailed over that of vegetal drugs or compounded herbal medicines.

  9. Tablets in Education. Results from the Initiative ETiE, for Teaching Plants to Primary School Students

    Science.gov (United States)

    Fokides, Emmanuel; Atsikpasi, Pinelopi

    2017-01-01

    The study presents the results from the first phase of the initiative Emerging Technologies in Education. At this stage, we examined the learning outcomes from the use of tablets and an application as content delivery methods for teaching plants' parts, reproduction types and organs, photosynthesis, and respiration. The project lasted for four…

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

    NARCIS (Netherlands)

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

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

  11. A governance model for integrated primary/secondary care for the health-reforming first world – results of a systematic review

    Science.gov (United States)

    2013-01-01

    Background Internationally, key health care reform elements rely on improved integration of care between the primary and secondary sectors. The objective of this systematic review is to synthesise the existing published literature on elements of current integrated primary/secondary health care. These elements and how they have supported integrated healthcare governance are presented. Methods A systematic review of peer-reviewed literature from PubMed, MEDLINE, CINAHL, the Cochrane Library, Informit Health Collection, the Primary Health Care Research and Information Service, the Canadian Health Services Research Foundation, European Foundation for Primary Care, European Forum for Primary Care, and Europa Sinapse was undertaken for the years 2006–2012. Relevant websites were also searched for grey literature. Papers were assessed by two assessors according to agreed inclusion criteria which were published in English, between 2006–2012, studies describing an integrated primary/secondary care model, and had reported outcomes in care quality, efficiency and/or satisfaction. Results Twenty-one studies met the inclusion criteria. All studies evaluated the process of integrated governance and service delivery structures, rather than the effectiveness of services. They included case reports and qualitative data analyses addressing policy change, business issues and issues of clinical integration. A thematic synthesis approach organising data according to themes identified ten elements needed for integrated primary/secondary health care governance across a regional setting including: joint planning; integrated information communication technology; change management; shared clinical priorities; incentives; population focus; measurement – using data as a quality improvement tool; continuing professional development supporting joint working; patient/community engagement; and, innovation. Conclusions All examples of successful primary/secondary care integration reported in

  12. Log-gamma directed polymer with fixed endpoints via the replica Bethe Ansatz

    International Nuclear Information System (INIS)

    Thiery, Thimothée; Le Doussal, Pierre

    2014-01-01

    We study the model of a discrete directed polymer (DP) on a square lattice with homogeneous inverse gamma distribution of site random Boltzmann weights, introduced by Seppalainen (2012 Ann. Probab. 40 19–73). The integer moments of the partition sum, Z n -bar , are studied using a transfer matrix formulation, which appears as a generalization of the Lieb–Liniger quantum mechanics of bosons to discrete time and space. In the present case of the inverse gamma distribution the model is integrable in terms of a coordinate Bethe Ansatz, as discovered by Brunet. Using the Brunet-Bethe eigenstates we obtain an exact expression for the integer moments of Z n -bar for polymers of arbitrary lengths and fixed endpoint positions. Although these moments do not exist for all integer n, we are nevertheless able to construct a generating function which reproduces all existing integer moments and which takes the form of a Fredholm determinant (FD). This suggests an analytic continuation via a Mellin–Barnes transform and we thereby propose a FD ansatz representation for the probability distribution function (PDF) of Z and its Laplace transform. In the limit of a very long DP, this ansatz yields that the distribution of the free energy converges to the Gaussian unitary ensemble (GUE) Tracy-Widom distribution up to a non-trivial average and variance that we calculate. Our asymptotic predictions coincide with a result by Borodin et al (2013 Commun. Math. Phys. 324 215–32) based on a formula obtained by Corwin et al (2011 arXiv:1110.3489) using the geometric Robinson–Schensted–Knuth (gRSK) correspondence. In addition we obtain the dependence on the endpoint position and the exact elastic coefficient at a large time. We argue the equivalence between our formula and that of Borodin et al. As we will discuss, this provides a connection between quantum integrability and tropical combinatorics. (paper)

  13. Cadmium phytotoxicity: Quantitative sensitivity relationships between classical endpoints and antioxidative enzyme biomarkers

    Energy Technology Data Exchange (ETDEWEB)

    Rosa Correa, Albertina Xavier da [Centro de Ciencias Tecnologicas da Terra e do Mar, Universidade do Vale do Itajai, Rua Uruguai, 458, 88302-202 Itajai SC (Brazil); Roerig, Leonardo Rubi [Centro de Ciencias Tecnologicas da Terra e do Mar, Universidade do Vale do Itajai, Rua Uruguai, 458, 88302-202 Itajai SC (Brazil); Verdinelli, Miguel A. [Centro de Ciencias Tecnologicas da Terra e do Mar, Universidade do Vale do Itajai, Rua Uruguai, 458, 88302-202 Itajai SC (Brazil); Cotelle, Sylvie [Centre des Sciences de l' Environnement, Universite de Metz, 57000 Metz (France); Ferard, Jean-Francois [Centre des Sciences de l' Environnement, Universite de Metz, 57000 Metz (France); Radetski, Claudemir Marcos [Centro de Ciencias Tecnologicas da Terra e do Mar, Universidade do Vale do Itajai, Rua Uruguai, 458, 88302-202 Itajai SC (Brazil)]. E-mail: radetski@univali.br

    2006-03-15

    In this work, cadmium phytotoxicity and quantitative sensitivity relationships between different hierarchical endpoints in plants cultivated in a contaminated soil were studied. Thus, germination rate, biomass growth and antioxidative enzyme activity (i.e. superoxide dismutase, peroxidase, catalase and glutathione reductase) in three terrestrial plants (Avena sativa L., Brassica campestris L. cv. Chinensis, Lactuca sativa L. cv. hanson) were analyzed. Plant growth tests were carried out according to an International Standard Organization method and the results were analyzed by ANOVA followed by Williams' test. The concentration of Cd{sup 2+} that had the smallest observed significant negative effect (LOEC) on plant biomass was 6.25, 12.5 and 50 mg Cd/kg dry soil for lettuce, oat and Chinese cabbage, respectively. Activity of all enzymes studied increased significantly compared to enzyme activity in plant controls. For lettuce, LOEC values (mg Cd/kg dry soil) for enzymic activity ranged from 0.05 (glutathione reductase) to 0.39 (catalase). For oat, LOEC values (mg Cd/kg dry soil) ranged from 0.19 (for superoxide dismutase and glutathione reductase) to 0.39 (for catalase and peroxidase). For Chinese cabbage, LOEC values (mg Cd/kg dry soil) ranged from 0.19 (peroxidase, catalase and glutathione reductase) to 0.39 (superoxide dismutase). Classical (i.e. germination and biomass) and biochemical (i.e. enzyme activity) endpoints were compared to establish a sensitivity ranking, which was: enzyme activity > biomass > germination rate. For cadmium-soil contamination, the determination of quantitative sensitivity relationships (QSR) between classical and antioxidative enzyme biomarkers showed that the most sensitive plant species have, generally, the lowest QSR values.

  14. Cadmium phytotoxicity: Quantitative sensitivity relationships between classical endpoints and antioxidative enzyme biomarkers

    International Nuclear Information System (INIS)

    Rosa Correa, Albertina Xavier da; Roerig, Leonardo Rubi; Verdinelli, Miguel A.; Cotelle, Sylvie; Ferard, Jean-Francois; Radetski, Claudemir Marcos

    2006-01-01

    In this work, cadmium phytotoxicity and quantitative sensitivity relationships between different hierarchical endpoints in plants cultivated in a contaminated soil were studied. Thus, germination rate, biomass growth and antioxidative enzyme activity (i.e. superoxide dismutase, peroxidase, catalase and glutathione reductase) in three terrestrial plants (Avena sativa L., Brassica campestris L. cv. Chinensis, Lactuca sativa L. cv. hanson) were analyzed. Plant growth tests were carried out according to an International Standard Organization method and the results were analyzed by ANOVA followed by Williams' test. The concentration of Cd 2+ that had the smallest observed significant negative effect (LOEC) on plant biomass was 6.25, 12.5 and 50 mg Cd/kg dry soil for lettuce, oat and Chinese cabbage, respectively. Activity of all enzymes studied increased significantly compared to enzyme activity in plant controls. For lettuce, LOEC values (mg Cd/kg dry soil) for enzymic activity ranged from 0.05 (glutathione reductase) to 0.39 (catalase). For oat, LOEC values (mg Cd/kg dry soil) ranged from 0.19 (for superoxide dismutase and glutathione reductase) to 0.39 (for catalase and peroxidase). For Chinese cabbage, LOEC values (mg Cd/kg dry soil) ranged from 0.19 (peroxidase, catalase and glutathione reductase) to 0.39 (superoxide dismutase). Classical (i.e. germination and biomass) and biochemical (i.e. enzyme activity) endpoints were compared to establish a sensitivity ranking, which was: enzyme activity > biomass > germination rate. For cadmium-soil contamination, the determination of quantitative sensitivity relationships (QSR) between classical and antioxidative enzyme biomarkers showed that the most sensitive plant species have, generally, the lowest QSR values

  15. Assessment of sublethal endpoints after chronic exposure of the nematode Caenorhabditis elegans to palladium, platinum and rhodium.

    Science.gov (United States)

    Schertzinger, Gerhard; Zimmermann, Sonja; Grabner, Daniel; Sures, Bernd

    2017-11-01

    The aim of this study was to investigate chronic effects of the platinum-group elements (PGE) palladium (Pd), platinum (Pt) and rhodium (Rh) on the nematode Caenorhabditis elegans. Aquatic toxicity testing was carried out according to ISO 10872 by determining 96 h EC 50 values for sublethal endpoints, including growth, fertility and reproduction. Single PGE standard solutions were used as metal source. Based on the EC 50 values for Pt, reproduction (96 h EC 50  = 497 μg/L) was the most sensitive endpoint followed by fertility (96 h EC 50  = 726 μg/L) and growth (96 h EC 50  = 808 μg/L). For Pd, no precise EC 50 values could be calculated due to bell-shaped concentration response curves, but the 96 h EC 50 for reproduction ranged between 10 and 100 μg/L. Pd and Pt had effects on all endpoints. With raising element concentrations reproduction was inhibited first. At a certain concentration, fertility was also affected, which in turn had an additional effect on reproduction. Growth inhibition can also lead to a loss of fertility if the worms do not reach an appropriate body size to become fertile. Rhodium showed no inhibition of any endpoint between concentrations of 100 to 10,000 μg Rh/L. The results of this study allow the following order of PGE with respect to decreasing toxicity to C. elegans: Pd > Pt » Rh. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. Verification results of methodology for determining the weighted mean coolant temperature in the primary circuit hot legs of WWER-1000 reactor plants

    Energy Technology Data Exchange (ETDEWEB)

    Saunin, Yuri V.; Dobrotvorski, Alexander N.; Semenikhin, Alexander V.; Korolev, Alexander S. [JSC ' ' Atomtechenergo' ' , Novovoronezh (Russian Federation). Novovoronezh Filial ' ' Novovoronezhatomtechenergo' ' ; Ryasny, Sergei I. [JSC ' ' Atomtechenergo' ' , Moscow (Russian Federation)

    2017-09-15

    The JSC ''Atomtechenergo'' experts have developed a new methodology for determining the weighted mean coolant temperature in the primary circuit hot legs of WWER-1000 reactor plants. The necessity for developing the new methodology was determined by the need to decrease the calculation error of the weighted mean coolant temperature in the hot legs because of the coolant temperature stratification. The methodology development was based on the findings of experimental and calculating research executed by the authors. The methodology verification was fulfilled through comparison of calculation results obtained with and without the methodology use in various operational states and modes of several WWER-1000 power units. The obtained verification results have confirmed that the use of the new methodology provides objective error decrease in determining the weighted mean coolant temperature in the primary circuit hot legs. The decrease value depends on the stratification character which is various for different objects and conditions.

  17. Verification results of methodology for determining the weighted mean coolant temperature in the primary circuit hot legs of WWER-1000 reactor plants

    International Nuclear Information System (INIS)

    Saunin, Yuri V.; Dobrotvorski, Alexander N.; Semenikhin, Alexander V.; Korolev, Alexander S.

    2017-01-01

    The JSC ''Atomtechenergo'' experts have developed a new methodology for determining the weighted mean coolant temperature in the primary circuit hot legs of WWER-1000 reactor plants. The necessity for developing the new methodology was determined by the need to decrease the calculation error of the weighted mean coolant temperature in the hot legs because of the coolant temperature stratification. The methodology development was based on the findings of experimental and calculating research executed by the authors. The methodology verification was fulfilled through comparison of calculation results obtained with and without the methodology use in various operational states and modes of several WWER-1000 power units. The obtained verification results have confirmed that the use of the new methodology provides objective error decrease in determining the weighted mean coolant temperature in the primary circuit hot legs. The decrease value depends on the stratification character which is various for different objects and conditions.

  18. The role of categorization and scale endpoint comparisons in numerical information processing: A two-process model.

    Science.gov (United States)

    Tao, Tao; Wyer, Robert S; Zheng, Yuhuang

    2017-03-01

    We propose a two-process conceptualization of numerical information processing to describe how people form impressions of a score that is described along a bounded scale. According to the model, people spontaneously categorize a score as high or low. Furthermore, they compare the numerical discrepancy between the score and the endpoint of the scale to which it is closer, if they are not confident of their categorization, and use implications of this comparison as a basis for judgment. As a result, their evaluation of the score is less extreme when the range of numbers along the scale is large (e.g., from 0 to 100) than when it is small (from 0 to 10). Six experiments support this two-process model and demonstrate its generalizability. Specifically, the magnitude of numbers composing the scale has less impact on judgments (a) when the score being evaluated is extreme, (b) when individuals are unmotivated to engage in endpoint comparison processes (i.e., they are low in need for cognition), and (c) when they are unable to do so (i.e., they are under cognitive load). Moreover, the endpoint to which individuals compare the score can depend on their regulatory focus. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  19. Pollutant threshold concentration determination in marine ecosystems using an ecological interaction endpoint

    International Nuclear Information System (INIS)

    Wang, Changyou; Liang, Shengkang; Guo, Wenting; Yu, Hua; Xing, Wenhui

    2015-01-01

    The threshold concentrations of pollutants are determined by extrapolating single-species effect data to community-level effects. This assumes the most sensitive endpoint of the life cycle of individuals and the species sensitivity distribution from single-species toxic effect tests, thus, ignoring the ecological interactions. The uncertainties due to this extrapolation can be partially overcome using the equilibrium point of a customized ecosystem. This method incorporates ecological interactions and integrates the effects on growth, survival, and ingestion into a single effect measure, the equilibrium point excursion in the customized ecosystem, in order to describe the toxic effects on plankton. A case study showed that the threshold concentration of copper calculated with the endpoint of the equilibrium point was 10 μg L −1 , which is significantly different from the threshold calculated with a single-species endpoint. The endpoint calculated using this method provides a more relevant measure of the ecological impact than any single individual-level endpoint. - Highlights: • Ecotoxicological effect of exposure to copper was tested on a customized ecosystem. • Equilibrium point of biomasses in the customized ecosystem was used as an endpoint. • Exposure–response relationship in a community level was built on equilibrium point. • A threshold concentration incorporating ecological interactions was derived. - The equilibrium biomass incorporating ecological interactions in a customized ecosystem was used as an endpoint to calculate the threshold concentration at a community level

  20. A comparison of chemoembolization endpoints using angiographic versus transcatheter intraarterial perfusion/MR imaging monitoring.

    Science.gov (United States)

    Lewandowski, Robert J; Wang, Dingxin; Gehl, James; Atassi, Bassel; Ryu, Robert K; Sato, Kent; Nemcek, Albert A; Miller, Frank H; Mulcahy, Mary F; Kulik, Laura; Larson, Andrew C; Salem, Riad; Omary, Reed A

    2007-10-01

    Transcatheter arterial chemoembolization (TACE) is an established treatment for unresectable liver cancer. This study was conducted to test the hypothesis that angiographic endpoints during TACE are measurable and reproducible by comparing subjective angiographic versus objective magnetic resonance (MR) endpoints of TACE. The study included 12 consecutive patients who presented for TACE for surgically unresectable HCC or progressive hepatic metastases despite chemotherapy. All procedures were performed with a dedicated imaging system. Angiographic series before and after TACE were reviewed independently by three board-certified interventional radiologists. A subjective angiographic chemoembolization endpoint (SACE) classification scheme, modified from an established angiographic grading system in the cardiology literature, was designed to assist in reproducibly classifying angiographic endpoints. Reproducibility in SACE classification level was compared among operators, and MR imaging perfusion reduction was compared with SACE levels for each observer. Twelve patients successfully underwent 15 separate TACE sessions. SACE levels ranged from I through IV. There was moderate agreement in SACE classification (kappa = 0.46 +/- 0.12). There was no correlation between SACE level and MR perfusion reduction (r = 0.16 for one operator and 0.02 for the other two). Angiographic endpoints during TACE vary widely, have moderate reproducibility among operators, and do not correlate with functional MR imaging perfusion endpoints. Future research should aim to determine ideal angiographic and functional MR imaging endpoints for TACE according to outcome measures such as imaging response, pathologic response, and survival.

  1. Pathologic Findings at Risk-Reducing Salpingo-Oophorectomy: Primary Results From Gynecologic Oncology Group Trial GOG-0199

    Science.gov (United States)

    Sherman, Mark E.; Piedmonte, Marion; Mai, Phuong L.; Ioffe, Olga B.; Ronnett, Brigitte M.; Van Le, Linda; Ivanov, Iouri; Bell, Maria C.; Blank, Stephanie V.; DiSilvestro, Paul; Hamilton, Chad A.; Tewari, Krishnansu S.; Wakeley, Katie; Kauff, Noah D.; Yamada, S. Diane; Rodriguez, Gustavo; Skates, Steven J.; Alberts, David S.; Walker, Joan L.; Minasian, Lori; Lu, Karen; Greene, Mark H.

    2014-01-01

    Purpose Risk-reducing salpingo-oophorectomy (RRSO) lowers mortality from ovarian/tubal and breast cancers among BRCA1/2 mutation carriers. Uncertainties persist regarding potential benefits of RRSO among high-risk noncarriers, optimal surgical age, and anatomic origin of clinically occult cancers detected at surgery. To address these topics, we analyzed surgical treatment arm results from Gynecologic Oncology Group Protocol-0199 (GOG-0199), the National Ovarian Cancer Prevention and Early Detection Study. Participants and Methods This analysis included asymptomatic high-risk women age ≥ 30 years who elected RRSO at enrollment. Women provided risk factor data and underwent preoperative cancer antigen 125 (CA-125) serum testing and transvaginal ultrasound (TVU). RRSO specimens were processed according to a standardized tissue processing protocol and underwent central pathology panel review. Research-based BRCA1/2 mutation testing was performed when a participant's mutation status was unknown at enrollment. Relationships between participant characteristics and diagnostic findings were assessed using univariable statistics and multivariable logistic regression. Results Invasive or intraepithelial ovarian/tubal/peritoneal neoplasms were detected in 25 (2.6%) of 966 RRSOs (BRCA1 mutation carriers, 4.6%; BRCA2 carriers, 3.5%; and noncarriers, 0.5%; P < .001). In multivariable models, positive BRCA1/2 mutation status (P = .0056), postmenopausal status (P = .0023), and abnormal CA-125 levels and/or TVU examinations (P < .001) were associated with detection of clinically occult neoplasms at RRSO. For 387 women with negative BRCA1/2 mutation testing and normal CA-125 levels, findings at RRSO were benign. Conclusion Clinically occult cancer was detected among 2.6% of high-risk women undergoing RRSO. BRCA1/2 mutation, postmenopausal status, and abnormal preoperative CA-125 and/or TVU were associated with cancer detection at RRSO. These data can inform management decisions

  2. Cervical human papilloma virus (HPV) DNA primary screening test: Results of a population-based screening programme in central Italy.

    Science.gov (United States)

    Passamonti, Basilio; Gustinucci, Daniela; Giorgi Rossi, Paolo; Cesarini, Elena; Bulletti, Simonetta; Carlani, Angela; Martinelli, Nadia; Broccolini, Massimo; D'Angelo, Valentina; D'Amico, Maria Rosaria; Di Dato, Eugenio; Galeazzi, Paola; Malaspina, Morena; Spita, Nicoletta; Tintori, Beatrice; Giaimo, Maria Donata

    2017-09-01

    Objective To present the results of the first and second round human papilloma virus (HPV)-based screening programme in the Umbria region after three years. Methods From August 2010 to November 2011, the entire female population aged 35-64 in a local health district was invited for HPV testing (HPV-DNA cobas4800 on a liquid-based cytology sample). HPV-negative women were re-invited after three years. For HPV-positive women, a slide was prepared and interpreted. Positive cytologies were referred to colposcopy; negatives were referred to repeat HPV after one year. If HPV was persistently positive, women were referred to colposcopy; if negative, to normal screening. Indicators of the first and second round are compared with those of cytology screening in the same area in the preceding three years. Results Participation was 56.5%, the same as cytology (56.6%). HPV-positivity was 6.4% (396/6272), cytology triage positivity was 35.6%; 251 cytology negative women were referred to one-year HPV retesting, 84.1% complied, and 55.5% were positive. Total colposcopy referral was 4.1%, and for cytology 1%. The detection rate for cervical intraepithelial neoplasia grade 2 or more severe was 10‰, compared with 3.7‰ using cytology. After three years, HPV-positivity was 3.4% (129/3831), overall colposcopy referral was 2.3% (most at one-year follow-up), and detection rate was 0.5/1000. Conclusions The first round detection rate was more than twice that of cytology screening, while colposcopy referral increased fourfold. At the second round, the detection rate decreased dramatically, showing that longer interval and more conservative protocols are needed.

  3. PRIMARY RESULTS OF LONG-TERM DYNAMIC MONITORING OF CHILDREN WITH BRONCHIAL ASTHMA OF UNCONTROLLED SEVERE PERSISTENT COURSE

    Directory of Open Access Journals (Sweden)

    L. S. Namazova-Baranova

    2016-01-01

    Full Text Available Background. Patients registers help obtain the latest information about the clinical course of a disease, safety and effectiveness of the medical technology. Objective: Our aim was to analyze the efficiency and safety of omalizumab with children suffering from uncontrolled severe persistent bronchial asthma (BA according to the data of the developed register. Methods.  A register of patients with severe asthma of uncontrolled course receiving omalizumab in addition to basic therapy has been developed. Results. Results of treatment of 101 children aged 6–17 have been analyzed. The duration of therapy with omalizumab lasted from 1 to 85 months, with a median of 16 (10; 44 months. The drug was used in doses of 75 to 600 mg, with a median of 300 (225; 375 mg. The therapy with omalizumab allowed achieving a better control of the disease (AST test prior to start of therapy — 14 (11; 17 points, in 1 year — 20 (13; 25; p < 0,001; reduction of the volume of daily base therapy (prior to start of therapy, average dose of inhaled corticosteroids in terms of fluticasone was 629 ± 304 mg (n = 15, in 4 years — 524 ± 342 mg; p = 0.065; reduction of the number of aggravations and the need to use short-effectiv   2-agonists.  No adverse systemic effects of the introduction of genetically engineered biological drugs have been found. Conclusion. Register of patients with severe persistent asthma can be used as a tool for long-term  monitoring and integrated assessment of the efficiency and safety of therapy.

  4. Treatment of Angio-Seal-Related Femoral Artery Occlusion Using Directional Atherectomy-Primary Results and Midterm Follow-Up.

    Science.gov (United States)

    Babaev, Anvar; Gokhale, Rohit; Zavlunova, Susanna; Attubato, Michael

    2016-11-01

    We describe a novel approach for the endovascular treatment of femoral artery occlusion as a result of Angio-Seal closure device deployment. Angio-Seal is the most commonly used vascular closure device following percutaneous coronary and peripheral catheterizations worldwide. A rare complication of Angio-Seal deployment is an occlusion of the femoral artery leading to limb ischemia requiring revascularization. Given its unique ability to cut both atherosclerotic plaque and the Angio-Seal anchor with a collagen plug at operator-directed planes, TurboHawk/HawkOne atherectomy device can be a fast and effective approach to treat Angio-Seal-associated femoral artery occlusions. We studied 13 consecutive patients who developed Angio-Seal-associated femoral artery occlusions that occurred from 3 hours to several weeks after catheterization. These patients were successfully treated with TurboHawk/HawkOne directional atherectomy followed by balloon angioplasty with no complications. During a mean follow-up period of 20.4 ± 17.3 months, 12 patients remained claudication free with no evidence of obstructive arterial disease of the treated segment on imaging studies. One patient developed restenosis that was treated with repeat atherectomy and balloon angioplasty following which he was asymptomatic at follow-up. The use of directional atherectomy followed by balloon angioplasty is a quick, safe, and effective endovascular approach to treating Angio-Seal-associated femoral artery occlusions. It is associated with an excellent success rate, no complications, and good midterm outcomes.

  5. Stereotactic Radiotherapy of Primary Lung Cancer and Other Targets: Results of Consultant Meeting of the International Atomic Energy Agency

    International Nuclear Information System (INIS)

    Nagata, Yasushi; Wulf, Joern; Lax, Ingmar; Timmerman, Robert; Zimmermann, Frank; Stojkovski, Igor; Jeremic, Branislav

    2011-01-01

    To evaluate the current status of stereotactic body radiotherapy (SBRT) and identify both advantages and disadvantages of its use in developing countries, a meeting composed of consultants of the International Atomic Energy Agency was held in Vienna in November 2006. Owing to continuous developments in the field, the meeting was extended by subsequent discussions and correspondence (2007-2010), which led to the summary presented here. The advantages and disadvantages of SBRT expected to be encountered in developing countries were identified. The definitions, typical treatment courses, and clinical results were presented. Thereafter, minimal methodology/technology requirements for SBRT were evaluated. Finally, characteristics of SBRT for developing countries were recommended. Patients for SBRT should be carefully selected, because single high-dose radiotherapy may cause serious complications in some serial organs at risk. Clinical experiences have been reported in some populations of lung cancer, lung oligometastases, liver cancer, pancreas cancer, and kidney cancer. Despite the disadvantages expected to be experienced in developing countries, SBRT using fewer fractions may be useful in selected patients with various extracranial cancers with favorable outcome and low toxicity.

  6. Relationship between markers of body fat and calcaneal bone stiffness differs between preschool and primary school children: results from the IDEFICS baseline survey.

    Science.gov (United States)

    Sioen, Isabelle; Mouratidou, Theodora; Herrmann, Diana; De Henauw, Stefaan; Kaufman, Jean-Marc; Molnár, Dénes; Moreno, Luis A; Marild, Staffan; Barba, Gianvincenzo; Siani, Alfonso; Gianfagna, Francesco; Tornaritis, Michael; Veidebaum, Toomas; Ahrens, Wolfgang

    2012-10-01

    The aim of this study was to investigate the relationship between markers of body fat and bone status assessed as calcaneal bone stiffness in a large sample of European healthy pre- and primary school children. Participants were 7,447 children from the IDEFICS study (spread over eight different European countries), age 6.1 ± 1.8 years (range 2.1-9.9), 50.5 % boys. Anthropometric measurements (weight, height, bioelectrical impedance, waist and hip circumference, and tricipital and subscapular skinfold thickness) as well as quantitative ultrasonographic measurements to determine calcaneal stiffness index (SI) were performed. Partial correlation analysis, linear regression analysis, and ANCOVA were stratified by sex and age group: preschool boys (n = 1,699) and girls (n = 1,599) and primary school boys (n = 2,062) and girls (n = 2,087). In the overall study population, the average calcaneal SI was equal to 80.2 ± 14.0, ranging 42.4-153. The results showed that preschool children with higher body fat had lower calcaneal SI (significant correlation coefficients between -0.05 and -0.20), while primary school children with higher body fat had higher calcaneal SI (significant correlation coefficients between 0.05 and 0.13). After adjusting for fat-free mass, both preschool and primary school children showed an inverse relationship between body fat and calcaneal stiffness. To conclude, body fat is negatively associated with calcaneal bone stiffness in children after adjustment for fat-free mass. Fat-free mass may confound the association in primary school children but not in preschool children. Muscle mass may therefore be an important determinant of bone stiffness.

  7. Is Antibiotic Prophylaxis for Percutaneous Radiofrequency Ablation (RFA) of Primary Liver Tumors Necessary? Results From a Single-Center Experience

    International Nuclear Information System (INIS)

    Bhatia, Shivank S.; Spector, Seth; Echenique, Ana; Froud, Tatiana; Suthar, Rekha; Lawson, Ivy; Dalal, Ravi; Dinh, Vy; Yrizarry, Jose; Narayanan, Govindarajan

    2015-01-01

    PurposeThe purpose of this study was to evaluate need for antibiotic prophylaxis for radiofrequency ablation (RFA) of liver tumors in patients with no significant co-existing risk factors for infection.Materials and MethodsFrom January 2004 to September 2013, 83 patients underwent 123 percutaneous RFA procedures for total of 152 hepatocellular carcinoma (HCC) lesions. None of the patients had pre-existing biliary enteric anastomosis (BEA) or any biliary tract abnormality predisposing to ascending biliary infection or uncontrolled diabetes mellitus. No pre- or post-procedure antibiotic prophylaxis was provided for 121 procedures. Data for potential risk factors were reviewed retrospectively and analyzed for the frequency of infectious complications, including abscess formation.ResultsOne patient (1/121 (0.8 %) RFA sessions) developed a large segment 5 liver abscess/infected biloma communicating with the gallbladder 7 weeks after the procedure, successfully treated over 10 weeks with IV and PO antibiotic therapy and percutaneous catheter drainage. This patient did not receive any antibiotics prior to RFA. During the procedure, there was inadvertent placement of RFA probe tines into the gallbladder. No other infectious complications were documented.ConclusionThese data suggest that the routine use of prophylactic antibiotics for liver RFA is not necessary in majority of the patients undergoing liver ablation for HCC and could be limited to patients with high-risk factors such as the presence of BEA or other biliary abnormalities, uncontrolled diabetes mellitus, and large centrally located tumors in close proximity to central bile ducts. Larger randomized studies are needed to confirm this hypothesis

  8. Is Antibiotic Prophylaxis for Percutaneous Radiofrequency Ablation (RFA) of Primary Liver Tumors Necessary? Results From a Single-Center Experience

    Energy Technology Data Exchange (ETDEWEB)

    Bhatia, Shivank S., E-mail: sbhatia1@med.miami.edu [University of Miami, Vascular/Interventional Radiology, Department of Radiology, Miller School of Medicine (United States); Spector, Seth, E-mail: sspector@med.miami.edu [University of Miami, Department of Surgery, VA Hospital (Veterans Affairs Medical Center) (United States); Echenique, Ana, E-mail: aechenique@med.miami.edu; Froud, Tatiana, E-mail: tfroud@med.miami.edu; Suthar, Rekha, E-mail: rsuthar@med.miami.edu; Lawson, Ivy, E-mail: i.lawson1@med.miami.edu; Dalal, Ravi, E-mail: rdalal@med.miami.edu [University of Miami, Vascular/Interventional Radiology, Department of Radiology, Miller School of Medicine (United States); Dinh, Vy, E-mail: vdinh@med.miami.edu [VA Hospital (Veterans Affairs Medical Center), Department of Medicine (United States); Yrizarry, Jose, E-mail: jyrizarr@med.miami.edu; Narayanan, Govindarajan, E-mail: gnarayanan@med.miami.edu [University of Miami, Vascular/Interventional Radiology, Department of Radiology, Miller School of Medicine (United States)

    2015-08-15

    PurposeThe purpose of this study was to evaluate need for antibiotic prophylaxis for radiofrequency ablation (RFA) of liver tumors in patients with no significant co-existing risk factors for infection.Materials and MethodsFrom January 2004 to September 2013, 83 patients underwent 123 percutaneous RFA procedures for total of 152 hepatocellular carcinoma (HCC) lesions. None of the patients had pre-existing biliary enteric anastomosis (BEA) or any biliary tract abnormality predisposing to ascending biliary infection or uncontrolled diabetes mellitus. No pre- or post-procedure antibiotic prophylaxis was provided for 121 procedures. Data for potential risk factors were reviewed retrospectively and analyzed for the frequency of infectious complications, including abscess formation.ResultsOne patient (1/121 (0.8 %) RFA sessions) developed a large segment 5 liver abscess/infected biloma communicating with the gallbladder 7 weeks after the procedure, successfully treated over 10 weeks with IV and PO antibiotic therapy and percutaneous catheter drainage. This patient did not receive any antibiotics prior to RFA. During the procedure, there was inadvertent placement of RFA probe tines into the gallbladder. No other infectious complications were documented.ConclusionThese data suggest that the routine use of prophylactic antibiotics for liver RFA is not necessary in majority of the patients undergoing liver ablation for HCC and could be limited to patients with high-risk factors such as the presence of BEA or other biliary abnormalities, uncontrolled diabetes mellitus, and large centrally located tumors in close proximity to central bile ducts. Larger randomized studies are needed to confirm this hypothesis.

  9. Real-World Massage Therapy Produces Meaningful Effectiveness Signal for Primary Care Patients with Chronic Low Back Pain: Results of a Repeated Measures Cohort Study.

    Science.gov (United States)

    Elder, William G; Munk, Niki; Love, Margaret M; Bruckner, Geza G; Stewart, Kathryn E; Pearce, Kevin

    2017-07-01

    While efficacy of massage and other nonpharmacological treatments for chronic low back pain is established, stakeholders have called for pragmatic studies of effectiveness in "real-world" primary health care. The Kentucky Pain Research and Outcomes Study evaluated massage impact on pain, disability, and health-related quality of life for primary care patients with chronic low back pain. We report effectiveness and feasibility results, and make comparisons with established minimal clinically important differences. Primary care providers referred eligible patients for 10 massage sessions with community practicing licensed massage therapists. Oswestry Disability Index and SF-36v2 measures obtained at baseline and postintervention at 12 and 24 weeks were analyzed with mixed linear models and Tukey's tests. Additional analyses examined clinically significant improvement and predictive patient characteristics. Of 104 enrolled patients, 85 and 76 completed 12 and 24 weeks of data collection, respectively. Group means improved at 12 weeks for all outcomes and at 24 weeks for SF-36v2's Physical Component Summary and Bodily Pain Domain. Of those with clinically improved disability at 12 weeks, 75% were still clinically improved at 24 weeks ( P  < 0.01). For SF-36v2 Physical and Mental Component Summaries, 55.4% and 43.4%, respectively, showed clinically meaningful improvement at 12 weeks, 46.1% and 30.3% at 24 weeks. For Bodily Pain Domain, 49.4% were clinically improved at 12 weeks, 40% at 24 weeks. Adults older than age 49 years had better pain and disability outcomes than younger adults. Results provide a meaningful signal of massage effect for primary care patients with chronic low back pain and call for further research in practice settings using pragmatic designs with control groups. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  10. 78 FR 49530 - Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop

    Science.gov (United States)

    2013-08-14

    ...] Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop AGENCY: Food and Drug... for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the... American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and the Pediatric IBD...

  11. On weighted hardy inequalities on semiaxis for functions vanishing at the endpoints

    Directory of Open Access Journals (Sweden)

    Stepanov Vladimir

    1997-01-01

    Full Text Available We study the weighted Hardy inequalities on the semiaxis of the form for functions vanishing at the endpoints together with derivatives up to the order . The case is completely characterized.

  12. 76 FR 51993 - Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability

    Science.gov (United States)

    2011-08-19

    ... clinical trials of therapeutic drugs and biological products. The draft guidance describes standards... important imaging endpoint is used in a clinical trial of a therapeutic drug or biological product... Services to the Chairman of [[Page 51994

  13. Reporting and evaluation of HIV-related clinical endpoints in two multicenter international clinical trials

    DEFF Research Database (Denmark)

    Lifson, A; Rhame, F; Bellosa, W

    2006-01-01

    adjudication between reviewers before diagnostic certainty was assigned. CONCLUSION: Important requirements for HIV trials using clinical endpoints include objective definitions of "confirmed" and "probable," a formal reporting process with adequate information and supporting source documentation, evaluation......PURPOSE: The processes for reporting and review of progression of HIV disease clinical endpoints are described for two large phase III international clinical trials. METHOD: SILCAAT and ESPRIT are multicenter randomized HIV trials evaluating the impact of interleukin-2 on disease progression...... and death in HIV-infected patients receiving antiretroviral therapy. We report definitions used for HIV progression of disease endpoints, procedures for site reporting of such events, processes for independent review of reported events by an Endpoint Review Committee (ERC), and the procedure...

  14. Evaluation of the efficacy of laser peripheral iridoplasty in reversing the darkroom provocative test result in Chinese patients with primary angle closure status post laser iridotomy

    Directory of Open Access Journals (Sweden)

    Ping Huang

    2015-06-01

    Full Text Available AIM: To investigate the efficacy and safety of krypton laser peripheral iridoplasty (LPIP for Chinese patients with primary angle closure (PAC or primary angle-closure glaucoma (PACG status post laser iridotomy in reversing the positive results of the dark room provocative test (DRPT.METHODS:This study was prospective, noncomparative, interventional case series. Thirty-three patients (thirty-eight eyes with PAC or PACG status post patent laser iridotomy and maintained normal intraocular pressure (IOP but with positive DRPT results were enrolled. All the subjects were treated with krypton LPIP. DRPT was repeated after krypton LPIP. Results of DRPT were recorded. The visual acuity, IOP and gonioscopy were analyzed before and after krypton LPIP. A minimum time limit for follow-up was 6mo.RESULTS:Thirty-three patients (thirty-eight eyes were followed for 17.7±8.37mo (range 7-41mo after LPIP. Positive results of DRPT decreased from 38 eyes to 9 eyes (23.7% after LPIP. Peripheral anterior synechiae of angle in 34 of 38 eyes (89.5% remained unchanged at dynamic gonioscopy throughout the follow-up period after LPIP.CONCLUSION:LPIP decreased positive rates of the DRPT significantly. The mechanism may be that LPIP minimized contact between the peripheral iris and trabecular meshwork, which is a key factor for developing peripheral anterior synechiae.

  15. Evaluation of the efficacy of laser peripheral iridoplasty in reversing the darkroom provocative test result in Chinese patients with primary angle closure status post laser iridotomy

    Institute of Scientific and Technical Information of China (English)

    Ping; Huang; Ling-Ling; Wu

    2015-01-01

    AIM: To investigate the efficacy and safety of krypton laser peripheral iridoplasty(LPIP) for Chinese patients with primary angle closure(PAC) or primary angle-closure glaucoma(PACG) status post laser iridotomy in reversing the positive results of the dark room provocative test(DRPT).METHODS: This study was prospective, noncomparative,interventional case series. Thirty-three patients(thirty-eight eyes) with PAC or PACG status post patent laser iridotomy and maintained normal intraocular pressure(IOP) but with positive DRPT results were enrolled. All the subjects were treated with krypton LPIP. DRPT was repeated after krypton LPIP. Results of DRPT were recorded. The visual acuity, IOP and gonioscopy were analyzed before and after krypton LPIP. A minimum time limit for follow-up was 6mo.RESULTS: Thirty-three patients(thirty-eight eyes)were followed for 17.7 ±8.37mo(range 7-41mo) after LPIP. Positive results of DRPT decreased from 38 eyes to9 eyes(23.7%) after LPIP. Peripheral anterior synechiae of angle in 34 of 38 eyes(89.5%) remained unchanged at dynamic gonioscopy throughout the follow-up period after LPIP.CONCLUSION: LPIP decreased positive rates of the DRPT significantly. The mechanism may be that LPIP minimized contact between the peripheral iris and trabecular meshwork, which is a key factor for developing peripheral anterior synechiae.

  16. Primary colectomy in patients with stage IV colon cancer and unresectable distant metastases improves overall survival: results of a multicentric study.

    Science.gov (United States)

    Karoui, Mehdi; Roudot-Thoraval, Françoise; Mesli, Farida; Mitry, Emmanuel; Aparicio, Thomas; Des Guetz, Gaetan; DesGuetz, Gaetan; Louvet, Christophe; Landi, Bruno; Tiret, Emmanuel; Sobhani, Iradj

    2011-08-01

    Whether patients with stage IV colon cancer and unresectable distant metastases should be managed by primary colectomy followed by chemotherapy or immediate chemotherapy without resection of the primary tumor is still controversial. This study aimed to evaluate predictive factors associated with survival in patients with stage IV colon cancer and unresectable distant metastases. This large retrospective multicentric study included 6 academic hospitals. This study was conducted at 6 Paris University Hospitals (Assistance Publique-Hôpitaux de Paris; Saint Antoine, Henri Mondor, Ambroise Paré, Hôpital Europeen Gorges Pompidou, Bichat, and Avicenne). Between 1998 and 2007, 208 patients with good performance status and stage IV colon cancer with unresectable distant metastases received chemotherapy, either as initial management or after primary tumor resection. Survival was estimated by use of the Kaplan-Meier method. Factors associated with survival were tested by means of a log-rank test. Results were expressed as median values with 95% confidence intervals. Factors independently related to survival were tested using a Cox regression model adjusted for a propensity score. Of the 208 patients, 85 underwent colectomy before chemotherapy, whereas 123 were treated with use of primary chemotherapy with or without biotherapy. At univariate analysis, the following factors were significantly associated with survival: primary colectomy (P = .031), secondary curative surgery (P < .001), well-differentiated primary tumor (P < .001), exclusive liver metastases (P < .027), absence of need for colonic stent (P = .009), and addition of antiangiogenic (P = .001) or anti-epidermal growth factor receptor (P = .013) drugs to chemotherapy. After Cox multivariate analysis and after adjusting for the propensity score, all of these factors, with the exception of two, colonic stent and anti-epidermal growth factor receptor drug, were found to be independently associated with overall

  17. SpEnD: Linked Data SPARQL Endpoints Discovery Using Search Engines

    OpenAIRE

    Yumusak, Semih; Dogdu, Erdogan; Kodaz, Halife; Kamilaris, Andreas

    2016-01-01

    In this study, a novel metacrawling method is proposed for discovering and monitoring linked data sources on the Web. We implemented the method in a prototype system, named SPARQL Endpoints Discovery (SpEnD). SpEnD starts with a "search keyword" discovery process for finding relevant keywords for the linked data domain and specifically SPARQL endpoints. Then, these search keywords are utilized to find linked data sources via popular search engines (Google, Bing, Yahoo, Yandex). By using this ...

  18. Comparative analysis of the results of various physical therapy techniques in the treatment of patients with primary open-angle glaucoma with chronic cerebral ischemia

    Directory of Open Access Journals (Sweden)

    Lazarev М.S.

    2012-06-01

    Full Text Available

    Aim of the study: to evaluate the effectiveness of the techniques of dynamic simultaneous transcranial magnetic therapy and resonance, and electrical stimulation, transcranial magnetic therapy and dynamic laser stimulation, magnetic simpatokorrektsii in the treatment of patients with primary open-angle glaucoma with chronic cerebral ischemia. Techniques. We observed 184 patients diagnosed with primary open-angle glaucoma who received different physical therapy techniques. Results. Patients treated with transcranial magnetic therapy and electrical stimulation or laser stimulation, in addition to improving visual function and improve the bioelectrical activity of the visual cortex, more pronounced than in other groups also observed the activation of the intraocular blood fow. Application of magnetic simpatokorrektsii allows for improvement of basic functional, electrophysiological and hemodynamic performance by reducing the activity of the sympathetic nervous system and reduce the vasopressor effect. Conclusion. Transcranial magnetic therapy in combination with electrical stimulation or laser stimulation is effective in the treatment of patients with POAG. In patients with primary open-angle glaucoma with chronic cerebral ischemia technique of magnetic sim-patokorrektsii compared with traditional methods of vasoactive therapy is more effective, which is manifested not only increase the visual functions, but also a decrease in cognitive impairment.

  19. The use of intermediate endpoints in the design of type 1 diabetes prevention trials.

    Science.gov (United States)

    Krischer, Jeffrey P

    2013-09-01

    This paper presents a rationale for the selection of intermediate endpoints to be used in the design of type 1 diabetes prevention clinical trials. Relatives of individuals diagnosed with type 1 diabetes were enrolled on the TrialNet Natural History Study and screened for diabetes-related autoantibodies. Those with two or more such autoantibodies were analysed with respect to increased HbA1c, decreased C-peptide following an OGTT, or abnormal OGTT values as intermediate markers of disease progression. Over 2 years, a 10% increase in HbA1c, and a 20% or 30% decrease in C-peptide from baseline, or progression to abnormal OGTT, occurred with a frequency between 20% and 41%. The 3- to 5-year risk of type 1 diabetes following each intermediate endpoint was high, namely 47% to 84%. The lower the incidence of the endpoint being reached, the higher the risk of diabetes. A diabetes prevention trial using these intermediate endpoints would require a 30% to 50% smaller sample size than one using type 1 diabetes as the endpoint. The use of an intermediate endpoint in diabetes prevention is based on the generally held view of disease progression from initial occurrence of autoantibodies through successive immunological and metabolic changes to manifest type 1 diabetes. Thus, these markers are suitable for randomised phase 2 trials, which can more rapidly screen promising new therapies, allowing them to be subsequently confirmed in definitive phase 3 trials.

  20. Development of Cardiovascular and Neurodevelopmental Metrics as Sublethal Endpoints for the Fish Embryo Toxicity Test.

    Science.gov (United States)

    Krzykwa, Julie C; Olivas, Alexis; Jeffries, Marlo K Sellin

    2018-06-19

    The fathead minnow fish embryo toxicity (FET) test has been proposed as a more humane alternative to current toxicity testing methods, as younger organisms are thought to experience less distress during toxicant exposure. However, the FET test protocol does not include endpoints that allow for the prediction of sublethal adverse outcomes, limiting its utility relative to other test types. Researchers have proposed the development of sublethal endpoints for the FET test to increase its utility. The present study 1) developed methods for previously unmeasured sublethal metrics in fathead minnows (i.e., spontaneous contraction frequency and heart rate) and 2) investigated the responsiveness of several sublethal endpoints related to growth (wet weight, length, and growth-related gene expression), neurodevelopment (spontaneous contraction frequency, and neurodevelopmental gene expression), and cardiovascular function and development (pericardial area, eye size and cardiovascular related gene expression) as additional FET test metrics using the model toxicant 3,4-dichloroaniline. Of the growth, neurological and cardiovascular endpoints measured, length, eye size and pericardial area were found to more responsive than the other endpoints, respectively. Future studies linking alterations in these endpoints to longer-term adverse impacts are needed to fully evaluate the predictive power of these metrics in chemical and whole effluent toxicity testing. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  1. Seasonality in depressive and anxiety symptoms among primary care patients and in patients with depressive and anxiety disorders; results from the Netherlands Study of Depression and Anxiety

    Science.gov (United States)

    2011-01-01

    Background Little is known about seasonality of specific depressive symptoms and anxiety symptoms in different patient populations. This study aims to assess seasonal variation of depressive and anxiety symptoms in a primary care population and across participants who were classified in diagnostic groups 1) healthy controls 2) patients with a major depressive disorder, 3) patients with any anxiety disorder and 4) patients with a major depression and any anxiety disorder. Methods Data were used from the Netherlands Study of Depression and Anxiety (NESDA). First, in 5549 patients from the NESDA primary care recruitment population the Kessler-10 screening questionnaire was used and data were analyzed across season in a multilevel linear model. Second, in 1090 subjects classified into four groups according to psychiatric status according to the Composite International Diagnostic Interview, overall depressive symptoms and atypical versus melancholic features were assessed with the Inventory of Depressive Symptoms. Anxiety and fear were assessed with the Beck Anxiety Inventory and the Fear questionnaire. Symptom levels across season were analyzed in a linear regression model. Results In the primary care population the severity of depressive and anxiety symptoms did not show a seasonal pattern. In the diagnostic groups healthy controls and patients with any anxiety disorder, but not patients with a major depressive disorder, showed a small rise in depressive symptoms in winter. Atypical and melancholic symptoms were both elevated in winter. No seasonal pattern for anxiety symptoms was found. There was a small gender related seasonal effect for fear symptoms. Conclusions Seasonal differences in severity or type of depressive and anxiety symptoms, as measured with a general screening instrument and symptom questionnaires, were absent or small in effect size in a primary care population and in patient populations with a major depressive disorder and anxiety disorders. PMID

  2. Series: The research agenda for general practice/family medicine and primary health care in Europe. Part 4. Results: specific problem solving skills.

    Science.gov (United States)

    Hummers-Pradier, Eva; Beyer, Martin; Chevallier, Patrick; Eilat-Tsanani, Sophia; Lionis, Christos; Peremans, Lieve; Petek, Davorina; Rurik, Imre; Soler, Jean Karl; Stoffers, Henri Ejh; Topsever, Pinar; Ungan, Mehmet; van Royen, Paul

    2010-09-01

    The 'Research Agenda for General Practice/Family Medicine and Primary Health Care in Europe' summarizes the evidence relating to the core competencies and characteristics of the Wonca Europe definition of GP/FM, and its implications for general practitioners/family doctors, researchers and policy makers. The European Journal of General Practice publishes a series of articles based on this document. The previous articles presented background, objectives, and methodology, as well results on 'primary care management' and 'community orientation' and the person-related core competencies of GP/FM. This article reflects on the general practitioner's 'specific problem solving skills'. These include decision making on diagnosis and therapy of specific diseases, accounting for the properties of primary care, but also research questions related to quality management and resource use, shared decision making, or professional education and development. Clinical research covers most specific diseases, but often lacks pragmatism and primary care relevance. Quality management is a stronghold of GP/FM research. Educational interventions can be effective when well designed for a specific setting and situation. However, their message that 'usual care' by general practitioners is insufficient may be problematic. GP and their patients need more research into diagnostic reasoning with a step-wise approach to increase predictive values in a setting characterized by uncertainty and low prevalence of specific diseases. Pragmatic comparative effectiveness studies of new and established drugs or non-pharmaceutical therapy are needed. Multi-morbidity and complexity should be addressed. Studies on therapy, communication strategies and educational interventions should consider impact on health and sustainability of effects.

  3. Five criteria for using a surrogate endpoint to predict treatment effect based on data from multiple previous trials.

    Science.gov (United States)

    Baker, Stuart G

    2018-02-20

    A surrogate endpoint in a randomized clinical trial is an endpoint that occurs after randomization and before the true, clinically meaningful, endpoint that yields conclusions about the effect of treatment on true endpoint. A surrogate endpoint can accelerate the evaluation of new treatments but at the risk of misleading conclusions. Therefore, criteria are needed for deciding whether to use a surrogate endpoint in a new trial. For the meta-analytic setting of multiple previous trials, each with the same pair of surrogate and true endpoints, this article formulates 5 criteria for using a surrogate endpoint in a new trial to predict the effect of treatment on the true endpoint in the new trial. The first 2 criteria, which are easily computed from a zero-intercept linear random effects model, involve statistical considerations: an acceptable sample size multiplier and an acceptable prediction separation score. The remaining 3 criteria involve clinical and biological considerations: similarity of biological mechanisms of treatments between the new trial and previous trials, similarity of secondary treatments following the surrogate endpoint between the new trial and previous trials, and a negligible risk of harmful side effects arising after the observation of the surrogate endpoint in the new trial. These 5 criteria constitute an appropriately high bar for using a surrogate endpoint to make a definitive treatment recommendation. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

  4. Physicians’ attitudes towards office-based delivery of methadone maintenance therapy: results from a cross-sectional survey of Nova Scotia primary-care physicians

    Directory of Open Access Journals (Sweden)

    Dooley Jessica

    2012-06-01

    Full Text Available Abstract Background Approximately 90,000 Canadians use opioids each year, many of whom experience health and social problems that affect the individual user, families, communities and the health care system. For those who wish to reduce or stop their opioid use, methadone maintenance therapy (MMT is effective and supporting evidence is well-documented. However, access and availability to MMT is often inconsistent, with greater inequity outside of urban settings. Involving community based primary-care physicians in the delivery of MMT could serve to expand capacity and accessibility of MMT programs. Little is known, however, about the extent to which MMT, particularly office-based delivery, is acceptable to physicians. The aim of this study is to survey physicians about their attitudes towards MMT, particularly office-based delivery, and the perceived barriers and facilitators to MMT delivery. Methods In May 2008, facilitated by the College of Physicians and Surgeons of Nova Scotia, a cross-sectional, e-mail survey of 950 primary-care physicians practicing in Nova Scotia, Canada was administered via the OPINIO on-line survey software, to assess the acceptability of office-based MMT. Logistic regressions, adjusted for physician sociodemographic characteristics, were used to examine the association between physicians’ willingness to participate in office-based MMT, and a series of measures capturing physician attitudes and knowledge about treatment approaches, opioid use, and methadone, as well as perceived barriers to MMT. Results Overall, 19.8% of primary-care physicians responded to the survey, with 56% who indicated that they would be willing to be involved in MMT under current or similar circumstances; however, willingness was associated with numerous attitudinal and systemic factors. The barriers to involvement in MMT that were frequently cited included a lack of training or experience in MMT, lack of support services, and potential

  5. Metastatic carcinoma in the cervical lymph nodes from an unknown primary site: results of bilateral neck plus mucosal irradiation vs. ipsilateral neck irradiation

    International Nuclear Information System (INIS)

    Reddy, Sarada P.; Marks, James E.

    1997-01-01

    Purpose: To compare the outcome for patients with squamous cell carcinoma of cervical lymph nodes metastatic from an unknown primary site who were irradiated to both sides of the neck and potential mucosal sites with opposed photon beams, and for those irradiated to the ipsilateral side of the neck alone with an electron beam. Methods and Materials: Fifty-two patients with squamous cell carcinoma metastatic to cervical lymph nodes from an unknown primary site were irradiated by two different methods. Thirty-six were irradiated with a bilateral technique (BT), i.e., to both sides of the neck, including the naso-oro-hypopharyngeal mucosa, and 16 were irradiated with an electron beam (EB) to the ipsilateral side of the neck alone. Twenty patients of the BT group and 11 of the EB group had cervical lymph node dissections, and the remaining 21 patients had lymph node biopsies, prior to radiotherapy. Results: Tumor control in the ipsilateral side of the neck did not differ for either radiation technique, but was significantly higher after lymph node dissection than after biopsy (90 vs. 48%; p = 0.0004). Control of subclinical metastases in the contralateral cervical lymph nodes was higher for patients irradiated with BT than for patients irradiated with EB (86 vs. 56%; p 0.03). The occult primary was later discovered in 8% of the patients in the BT group and 44% of the EB group (p = 0.0005). The disease-free survival rate at 5 years for patients who had lymph node dissection prior to irradiation was 61%, and was 37% for those who had biopsy (p = 0.05). Only 20% of patients who subsequently developed an occult primary were salvaged and survived for 5 years after salvage treatment. Conclusion: Bilateral neck and mucosal irradiation is superior to ipsilateral neck irradiation in preventing contralateral cervical lymph node metastases and the subsequent appearance of an occult primary cancer. Both techniques combined with cervical lymph node dissection were equally effective

  6. External beam and HDR intracavitary irradiation: an effective tool in the primary treatment of cervical cancer - excellent 10 year results and low side effects

    International Nuclear Information System (INIS)

    Hammer, J.; Zoidl, J.P.; Track, C.; Seewald, D.H.; Labeck, W.

    1996-01-01

    Introduction: The purpose of this paper is to present our 15 years experience in the primary treatment of cervical cancer with a combination of external beam irradiation and high dose rate brachytherapy. Survival data will be presented and the safe use of intrauterine HDR applications will be demonstrated. Material and Methods: From August 1980 to December 1990, 303 patients with cancer of the uterine cervix underwent primary irradiation in a combination of external beam and HDR intracavitary treatment at the Department of Radiation Oncology at the Sisters of Mercy Hospital in Linz, Austria. All patients were classified according to the FIGO rules: Stage I 54 patients, stage II 171, stage III 75 and stage IV 3 patients. 8 patients were lost to follow up. The mean follow up time of survivors is 110 months. Results and Discussion: A complete remission could be achieved in 282 patients, which is 93%; persistent tumour was found in 21 patients at the first follow up check 3 to 5 months after completion of irradiation. The actuarial overall survival probability for all patients at 5 and 10 years is 62 % and 42 % respectively, the disease specific survival probability is 68 % and 64 %. The local control rate at 5 and 10 years is 73 % and 72 % respectively. According to stage, disease specific survival lies at 90 % for stage I, 69 % for stage II, and 48 % for stage III and IV at 5 years, and at 10 years 87 %, 66 % and 41 % respectively. The actuarial local control probability for stages I, II, and III/IV is 90 %, 74 %, and 60 % respectively at 5 yr, and 88 %, 74 %, and 56 % at 10 yr. (Kaplan-Meier calculations). From all 303 patients 34 suffered from 40 severe and moderate side effects (glossary of Chassagne and Sismondi). The rate for grade II complications is 10 % and for grade III 3 %. Conclusion: Intrauterine HDR brachycurietherapy in addition to external beam irradiation for primary treatment of invasive carcinoma of the uterine cervix provides the same treatment

  7. External beam and HDR intracavitary irradiation: an effective tool in the primary treatment of cancer of the uterine cervix - excellent 10 year results and low side effects

    International Nuclear Information System (INIS)

    Hammer, Josef; Zoidl, Johann P.; Track, Christine; Seewald, Dietmar H.; Labeck, Werner

    1996-01-01

    Purpose/Objective: The purpose of this paper is to present our 15 years experience in the primary treatment of cervical cancer with a combination of external beam irradiation and high dose rate brachytherapy. Survival data will be presented and the safe use of intrauterine HDR applications will be demonstrated. Material and Methods: From August 1980 to December 1990, 303 patients with cancer of the uterine cervix underwent primary irradiation in a combination of external beam and HDR intracavitary treatment at the Department of Radiation Oncology at the Sisters of Mercy Hospital in Linz, Austria. All patients were classified according to the FIGO rules: Stage I 54 patients, stage II 171, stage III 75 and stage IV 3 patients. 8 patients were lost to follow up. The mean follow up time of survivors is 110 months. Results: A complete remission could be achieved in 282 patients (93%); persistent tumour was found in 21 patients at the first follow up check 3 to 5 months after completion of irradiation. The actuarial overall survival probability for all patients at 5 and 10 years is 62 % and 49 % respectively, the disease specific survival probability is 68 % and 64 %. The local control rate at 5 and 10 years is 73 % and 72 % respectively. According to stage, disease specific survival lies at 90 % for stage I, 69 % for stage II, and 49 % for stage III and IV at 5 years, and at 10 years 87 %, 66 % and 41 % respectively. The actuarial local control probability for stages I, II, and III/IV is 90 %, 74 %, and 60 % respectively at 5 years, and 88 %, 74 %, and 57 % at 10 years (Kaplan-Meier calculations). From all 303 patients 34 suffered from 40 severe and moderate side effects (glossary of Chassagne and Sismondi). The rate for grade II complications is 10 % and for grade III 3 %. Conclusion: Intrauterine HDR brachycurietherapy in addition to external beam irradiation for primary treatment of invasive carcinoma of the uterine cervix provides the same treatment results as LDR

  8. Feeling labeled, judged, lectured, and rejected by family and friends over depression: Cautionary results for primary care clinicians from a multi-centered, qualitative study

    Directory of Open Access Journals (Sweden)

    Y-Garcia Erik

    2012-06-01

    Full Text Available Abstract Background Family and friends may help patients seek out and engage in depression care. However, patients’ social networks can also undermine depression treatment and recovery. In an effort to improve depression care in primary care settings, we sought to identify, categorize, and alert primary care clinicians to depression-related messages that patients hear from friends and family that patients perceive as unhelpful or detrimental. Methods We conducted 15 focus groups in 3 cities. Participants (n = 116 with a personal history or knowledge of depression responded to open-ended questions about depression, including self-perceived barriers to care-seeking. Focus group conversations were audio-recorded and analyzed using iterative qualitative analysis. Results Four themes emerged related to negatively-received depression messages delivered by family and friends. Specifically, participants perceived these messages as making them feel labeled, judged, lectured to, and rejected by family and friends when discussing depression. Some participants also expressed their interpretation of their families’ motivations for delivering the messages and described how hearing these messages affected depression care. Conclusions The richness of our results reflects the complexity of communication within depression sufferers’ social networks around this stigmatized issue. To leverage patients’ social support networks effectively in depression care, primary care clinicians should be aware of both the potentially beneficial and detrimental aspects of social support. Specifically, clinicians should consider using open-ended queries into patients’ experiences with discussing depression with family and friends as an initial step in the process. An open-ended approach may avoid future emotional trauma or stigmatization and assist patients in overcoming self-imposed barriers to depression discussion, symptom disclosure, treatment adherence and

  9. Is Primary Prostate Cancer Treatment Influenced by Likelihood of Extraprostatic Disease? A Surveillance, Epidemiology and End Results Patterns of Care Study

    International Nuclear Information System (INIS)

    Holmes, Jordan A.; Wang, Andrew Z.; Hoffman, Karen E.; Hendrix, Laura H.; Rosenman, Julian G.; Carpenter, William R.; Godley, Paul A.; Chen, Ronald C.

    2012-01-01

    Purpose: To examine the patterns of primary treatment in a recent population-based cohort of prostate cancer patients, stratified by the likelihood of extraprostatic cancer as predicted by disease characteristics available at diagnosis. Methods and Materials: A total of 157,371 patients diagnosed from 2004 to 2008 with clinically localized and potentially curable (node-negative, nonmetastatic) prostate cancer, who have complete information on prostate-specific antigen, Gleason score, and clinical stage, were included. Patients with clinical T1/T2 disease were grouped into categories of 50% likelihood of having extraprostatic disease using the Partin nomogram. Clinical T3/T4 patients were examined separately as the highest-risk group. Logistic regression was used to examine the association between patient group and receipt of each primary treatment, adjusting for age, race, year of diagnosis, marital status, Surveillance, Epidemiology and End Results database region, and county-level education. Separate models were constructed for primary surgery, external-beam radiotherapy (RT), and conservative management. Results: On multivariable analysis, increasing likelihood of extraprostatic disease was significantly associated with increasing use of RT and decreased conservative management. Use of surgery also increased. Patients with >50% likelihood of extraprostatic cancer had almost twice the odds of receiving prostatectomy as those with 50% likelihood of extraprostatic cancer (34%) and clinical T3–T4 disease (24%). The proportion of patients who received prostatectomy or conservative management was approximately 50% or slightly higher in all groups. Conclusions: There may be underutilization of RT in older prostate cancer patients and those with likely extraprostatic disease. Because more than half of prostate cancer patients do not consult with a radiation oncologist, a multidisciplinary consultation may affect the treatment decision-making process.

  10. An European inter-laboratory validation of alternative endpoints of the murine local lymph node assay: first round.

    Science.gov (United States)

    Ehling, G; Hecht, M; Heusener, A; Huesler, J; Gamer, A O; van Loveren, H; Maurer, Th; Riecke, K; Ullmann, L; Ulrich, P; Vandebriel, R; Vohr, H-W

    2005-08-15

    The new OECD guideline 429 (skin sensitization: local lymph node assay) is based upon a protocol, which utilises the incorporation of radioactivity into DNA as a measure for cell proliferation in vivo. The guideline also enables the use of alternative endpoints in order to assess draining lymph node (LN) cell proliferation. Here we describe the first round of an inter-laboratory validation of alternative endpoints in the LLNA conducted in seven laboratories. The validation study was managed and supervised by the Swiss Agency for Therapeutic Products, Swissmedic. Statistical analyses of all data were performed by an independent centre at the University of Bern, Department of Statistics. Ear-draining, LN weight and cell count were used to assess proliferation instead of radioactive labeling of lymph node cells. In addition, the acute inflammatory skin reaction was measured by ear swelling and weight of circular biopsies of the ears to identify skin irritating properties of the test items. Hexylcinnamaldehyde (HCA) and three blinded test items were applied to female, 8--10 weeks old NMRI and BALB/c mice. Results were sent via the independent study coordinator to the statistician. The results of this first round showed that the alternative endpoints of the LLNA are sensitive and robust parameters. The use of ear weights added an important parameter assessing the skin irritation potential, which supports the differentiation of pure irritative from contact allergenic potential. There were absolute no discrepancies between the categorisation of the three test substances A--C determined by each single participating laboratories. The results highlighted also that many parameters do have an impact on the strength of the responses. Therefore, such parameters have to be taken into consideration for the categorisation of compounds due to their relative sensitizing potencies.

  11. An European inter-laboratory validation of alternative endpoints of the murine local lymph node assay: First round

    International Nuclear Information System (INIS)

    Ehling, G.; Hecht, M.; Heusener, A.; Huesler, J.; Gamer, A.O.; Loveren, H. van; Maurer, Th.; Riecke, K.; Ullmann, L.; Ulrich, P.; Vandebriel, R.; Vohr, H.-W.

    2005-01-01

    The new OECD guideline 429 (skin sensitization: local lymph node assay) is based upon a protocol, which utilises the incorporation of radioactivity into DNA as a measure for cell proliferation in vivo. The guideline also enables the use of alternative endpoints in order to assess draining lymph node (LN) cell proliferation. Here we describe the first round of an inter-laboratory validation of alternative endpoints in the LLNA conducted in seven laboratories. The validation study was managed and supervised by the Swiss Agency for Therapeutic Products, Swissmedic. Statistical analyses of all data were performed by an independent centre at the University of Bern, Department of Statistics. Ear-draining, LN weight and cell count were used to assess proliferation instead of radioactive labeling of lymph node cells. In addition, the acute inflammatory skin reaction was measured by ear swelling and weight of circular biopsies of the ears to identify skin irritating properties of the test items. Hexylcinnamaldehyde (HCA) and three blinded test items were applied to female, 8-10 weeks old NMRI and BALB/c mice. Results were sent via the independent study coordinator to the statistician. The results of this first round showed that the alternative endpoints of the LLNA are sensitive and robust parameters. The use of ear weights added an important parameter assessing the skin irritation potential, which supports the differentiation of pure irritative from contact allergenic potential. There were absolute no discrepancies between the categorisation of the three test substances A-C determined by each single participating laboratories. The results highlighted also that many parameters do have an impact on the strength of the responses. Therefore, such parameters have to be taken into consideration for the categorisation of compounds due to their relative sensitizing potencies

  12. Environmentally acceptable endpoints for PAHs at a manufactured gas plant site

    Energy Technology Data Exchange (ETDEWEB)

    Stroo, H.F.; Jensen, R.; Loehr, R.C.; Nakles, D.V.; Fairbrother, A.; Liban, C.B. [ThermoRetec Corp., Carson, CA (USA)

    2000-09-01

    Samples from a former manufactured gas plant (MGP) site in Santa Barbara, CA were tested to evaluate the environmentally acceptable endpoints (EAE) process for setting risk-based cleanup criteria. The research was part of an ongoing effort to develop and demonstrate a protocol for assessing risk-based criteria for MGP sites that incorporates the availability of polycyclic aromatic hydrocarbons (PAHs). Six soil samples were subjected to a battery of physical and biological tests that focused on determining the 'availability' of the soil-bound contaminants to groundwater, ecological receptors, and human receptors. Results demonstrated that sorption to soil, matrix effects, aging, and treatment can significantly reduce chemical availability. Including these reduced availability results in risk assessment calculations yielded environmentally protective cleanup levels almost 3-10 times greater than levels derived using California default risk assessment assumptions. Using an EAE-based approach for MGP soils, especially those containing lampblack, could provide more realistic risk assessment. 23 refs., 6 tabs.

  13. Speech endpoint detection with non-language speech sounds for generic speech processing applications

    Science.gov (United States)

    McClain, Matthew; Romanowski, Brian

    2009-05-01

    Non-language speech sounds (NLSS) are sounds produced by humans that do not carry linguistic information. Examples of these sounds are coughs, clicks, breaths, and filled pauses such as "uh" and "um" in English. NLSS are prominent in conversational speech, but can be a significant source of errors in speech processing applications. Traditionally, these sounds are ignored by speech endpoint detection algorithms, where speech regions are identified in the audio signal prior to processing. The ability to filter NLSS as a pre-processing step can significantly enhance the performance of many speech processing applications, such as speaker identification, language identification, and automatic speech recognition. In order to be used in all such applications, NLSS detection must be performed without the use of language models that provide knowledge of the phonology and lexical structure of speech. This is especially relevant to situations where the languages used in the audio are not known apriori. We present the results of preliminary experiments using data from American and British English speakers, in which segments of audio are classified as language speech sounds (LSS) or NLSS using a set of acoustic features designed for language-agnostic NLSS detection and a hidden-Markov model (HMM) to model speech generation. The results of these experiments indicate that the features and model used are capable of detection certain types of NLSS, such as breaths and clicks, while detection of other types of NLSS such as filled pauses will require future research.

  14. Improving the Diagnosis and Treatment of Urinary Tract Infection in Young Children in Primary Care: Results from the DUTY Prospective Diagnostic Cohort Study

    Science.gov (United States)

    Hay, Alastair D.; Sterne, Jonathan A. C.; Hood, Kerenza; Little, Paul; Delaney, Brendan; Hollingworth, William; Wootton, Mandy; Howe, Robin; MacGowan, Alasdair; Lawton, Michael; Busby, John; Pickles, Timothy; Birnie, Kate; O’Brien, Kathryn; Waldron, Cherry-Ann; Dudley, Jan; Van Der Voort, Judith; Downing, Harriet; Thomas-Jones, Emma; Harman, Kim; Lisles, Catherine; Rumsby, Kate; Durbaba, Stevo; Whiting, Penny; Butler, Christopher C.

    2016-01-01

    PURPOSE Up to 50% of urinary tract infections (UTIs) in young children are missed in primary care. Urine culture is essential for diagnosis, but urine collection is often difficult. Our aim was to derive and internally validate a 2-step clinical rule using (1) symptoms and signs to select children for urine collection; and (2) symptoms, signs, and dipstick testing to guide antibiotic treatment. METHODS We recruited acutely unwell children aged under 5 years from 233 primary care sites across England and Wales. Index tests were parent-reported symptoms, clinician-reported signs, urine dipstick results, and clinician opinion of UTI likelihood (clinical diagnosis before dipstick and culture). The reference standard was microbiologically confirmed UTI cultured from a clean-catch urine sample. We calculated sensitivity, specificity, and area under the receiver operator characteristic (AUROC) curve of coefficient-based (graded severity) and points-based (dichotomized) symptom/sign logistic regression models, and we then internally validated the AUROC using bootstrapping. RESULTS Three thousand thirty-six children provided urine samples, and culture results were available for 2,740 (90%). Of these results, 60 (2.2%) were positive: the clinical diagnosis was 46.6% sensitive, with an AUROC of 0.77. Previous UTI, increasing pain/crying on passing urine, increasingly smelly urine, absence of severe cough, increasing clinician impression of severe illness, abdominal tenderness on examination, and normal findings on ear examination were associated with UTI. The validated coefficient- and points-based model AUROCs were 0.87 and 0.86, respectively, increasing to 0.90 and 0.90, respectively, by adding dipstick nitrites, leukocytes, and blood. CONCLUSIONS A clinical rule based on symptoms and signs is superior to clinician diagnosis and performs well for identifying young children for noninvasive urine sampling. Dipstick results add further diagnostic value for empiric antibiotic

  15. Feeling labeled, judged, lectured, and rejected by family and friends over depression: cautionary results for primary care clinicians from a multi-centered, qualitative study.

    Science.gov (United States)

    Fernandez Y-Garcia, Erik; Duberstein, Paul; Paterniti, Debora A; Cipri, Camille S; Kravitz, Richard L; Epstein, Ronald M

    2012-06-29

    Family and friends may help patients seek out and engage in depression care. However, patients' social networks can also undermine depression treatment and recovery. In an effort to improve depression care in primary care settings, we sought to identify, categorize, and alert primary care clinicians to depression-related messages that patients hear from friends and family that patients perceive as unhelpful or detrimental. We conducted 15 focus groups in 3 cities. Participants (n = 116) with a personal history or knowledge of depression responded to open-ended questions about depression, including self-perceived barriers to care-seeking. Focus group conversations were audio-recorded and analyzed using iterative qualitative analysis. Four themes emerged related to negatively-received depression messages delivered by family and friends. Specifically, participants perceived these messages as making them feel labeled, judged, lectured to, and rejected by family and friends when discussing depression. Some participants also expressed their interpretation of their families' motivations for delivering the messages and described how hearing these messages affected depression care. The richness of our results reflects the complexity of communication within depression sufferers' social networks around this stigmatized issue. To leverage patients' social support networks effectively in depression care, primary care clinicians should be aware of both the potentially beneficial and detrimental aspects of social support. Specifically, clinicians should consider using open-ended queries into patients' experiences with discussing depression with family and friends as an initial step in the process. An open-ended approach may avoid future emotional trauma or stigmatization and assist patients in overcoming self-imposed barriers to depression discussion, symptom disclosure, treatment adherence and follow-up care.

  16. Comparing sensitivity of ecotoxicological effect endpoints between laboratory and field

    DEFF Research Database (Denmark)

    Selck, H.; Riemann, B.; Christoffersen, K.

    2002-01-01

    multispecies field tests using tributyltin (TBT) and linear alkylbenzene sulfonates (LAS) were compared with published laboratory single-species test results and measured in situ concentrations. Extrapolation methods were evaluated by comparing predicted no-effect concentrations (PNECs), calculated by AF...

  17. Improving the Diagnosis and Treatment of Urinary Tract Infection in Young Children in Primary Care: Results from the DUTY Prospective Diagnostic Cohort Study.

    Science.gov (United States)

    Hay, Alastair D; Sterne, Jonathan A C; Hood, Kerenza; Little, Paul; Delaney, Brendan; Hollingworth, William; Wootton, Mandy; Howe, Robin; MacGowan, Alasdair; Lawton, Michael; Busby, John; Pickles, Timothy; Birnie, Kate; O'Brien, Kathryn; Waldron, Cherry-Ann; Dudley, Jan; Van Der Voort, Judith; Downing, Harriet; Thomas-Jones, Emma; Harman, Kim; Lisles, Catherine; Rumsby, Kate; Durbaba, Stevo; Whiting, Penny; Butler, Christopher C

    2016-07-01

    Up to 50% of urinary tract infections (UTIs) in young children are missed in primary care. Urine culture is essential for diagnosis, but urine collection is often difficult. Our aim was to derive and internally validate a 2-step clinical rule using (1) symptoms and signs to select children for urine collection; and (2) symptoms, signs, and dipstick testing to guide antibiotic treatment. We recruited acutely unwell children aged under 5 years from 233 primary care sites across England and Wales. Index tests were parent-reported symptoms, clinician-reported signs, urine dipstick results, and clinician opinion of UTI likelihood (clinical diagnosis before dipstick and culture). The reference standard was microbiologically confirmed UTI cultured from a clean-catch urine sample. We calculated sensitivity, specificity, and area under the receiver operator characteristic (AUROC) curve of coefficient-based (graded severity) and points-based (dichotomized) symptom/sign logistic regression models, and we then internally validated the AUROC using bootstrapping. Three thousand thirty-six children provided urine samples, and culture results were available for 2,740 (90%). Of these results, 60 (2.2%) were positive: the clinical diagnosis was 46.6% sensitive, with an AUROC of 0.77. Previous UTI, increasing pain/crying on passing urine, increasingly smelly urine, absence of severe cough, increasing clinician impression of severe illness, abdominal tenderness on examination, and normal findings on ear examination were associated with UTI. The validated coefficient- and points-based model AUROCs were 0.87 and 0.86, respectively, increasing to 0.90 and 0.90, respectively, by adding dipstick nitrites, leukocytes, and blood. A clinical rule based on symptoms and signs is superior to clinician diagnosis and performs well for identifying young children for noninvasive urine sampling. Dipstick results add further diagnostic value for empiric antibiotic treatment. © 2016 Annals of Family

  18. Adaption, implementation and evaluation of collaborative service improvements in the testing and result communication process in primary care from patient and staff perspectives: a qualitative study.

    Science.gov (United States)

    Litchfield, Ian J; Bentham, Louise M; Lilford, Richard J; McManus, Richard J; Hill, Ann; Greenfield, Sheila

    2017-08-30

    Increasing numbers of blood tests are being ordered in primary care settings and the swift and accurate communication of test results is central to providing high quality care. The process of testing and result communication is complex and reliant on the coordinated actions of care providers, external groups in laboratory and hospital settings, and patients. This fragmentation leaves it vulnerable to error and the need to improve an apparently fallible system is apparent. However, primary care is complex and does not necessarily adopt change in a linear and prescribed manner influenced by a range of factors relating to practice staff, patients and organisational factors. To account for these competing perspectives, we worked in conjunction with both staff and patients to develop and implement strategies intended to improve patient satisfaction and increase efficiency of existing processes. The study applied the principles of 'experience-based co-design' to identify key areas of weakness and source proposals for change from staff and patients. The study was undertaken within two primary practices situated in South Birmingham (UK) of contrasting size and socio-economic environment. Senior practice staff were involved in the refinement of the interventions for introduction. We conducted focus groups singly constituted of staff and patients at each practice to determine suitability, applicability and desirability alongside the practical implications of their introduction. At each practice four of the six proposals for change were implemented these were increased access to phlebotomy, improved receptionist training, proactive communication of results, and increased patient awareness of the tests ordered and the means of their communication. All were received favourably by both patients and staff. The remaining issues around the management of telephone calls and the introduction of electronic alerts for missing results were not addressed due to constraints of time and

  19. Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients (LapOvCa-trial): a multicentre randomized controlled study

    International Nuclear Information System (INIS)

    Rutten, Marianne J; Pijnenborg, Johanna MA; Schreuder, Henk WR; Schutter, Eltjo MJ; Spijkerboer, Anje M; Wensveen, Celesta WM; Zusterzeel, Petra; Mol, Ben Willem J; Kenter, Gemma G; Buist, Marrije R; Gaarenstroom, Katja N; Van Gorp, Toon; Meurs, Hannah S van; Arts, Henriette JG; Bossuyt, Patrick M; Ter Brugge, Henk G; Hermans, Ralph HM; Opmeer, Brent C

    2012-01-01

    Standard treatment of advanced ovarian cancer is surgery and chemotherapy. The goal of surgery is to remove all macroscopic tumour, as the amount of residual tumour is the most important prognostic factor for survival. When removal off all tumour is considered not feasible, neoadjuvant chemotherapy (NACT) in combination with interval debulking surgery (IDS) is performed. Current methods of staging are not always accurate in predicting surgical outcome, since approximately 40% of patients will have more than 1 cm residual tumour after primary debulking surgery (PDS). In this study we aim to assess whether adding laparoscopy to the diagnostic work-up of patients suspected of advanced ovarian carcinoma may prevent unsuccessful primary debulking surgery for ovarian cancer. Multicentre randomized controlled trial, including all gynaecologic oncologic centres in the Netherlands and their affiliated hospitals. Patients are eligible when they are planned for PDS after conventional staging. Participants are randomized between direct PDS or additional diagnostic laparoscopy. Depending on the result of laparoscopy patients are treated by PDS within three weeks, followed by six courses of platinum based chemotherapy or with NACT and IDS 3-4 weeks after three courses of chemotherapy, followed by another three courses of chemotherapy. Primary outcome measure is the proportion of PDS's leaving more than one centimetre tumour residual in each arm. In total 200 patients will be randomized. Data will be analysed according to intention to treat. Patients who have disease considered to be resectable to less than one centimetre should undergo PDS to improve prognosis. However, there is a need for better diagnostic procedures because the current number of debulking surgeries leaving more than one centimetre residual tumour is still high. Laparoscopy before starting treatment for ovarian cancer can be an additional diagnostic tool to predict the outcome of PDS. Despite the absence

  20. Multi-Toxic Endpoints of the Foodborne Mycotoxins in Nematode Caenorhabditis elegans

    Directory of Open Access Journals (Sweden)

    Zhendong Yang

    2015-12-01

    Full Text Available Aflatoxins B1 (AFB1, deoxynivalenol (DON, fumonisin B1 (FB1, T-2 toxin (T-2, and zearalenone (ZEA are the major foodborne mycotoxins of public health concerns. In the present study, the multiple toxic endpoints of these naturally-occurring mycotoxins were evaluated in Caenorhabditis elegans model for their lethality, toxic effects on growth and reproduction, as well as influence on lifespan. We found that the lethality endpoint was more sensitive for T-2 toxicity with the EC50 at 1.38 mg/L, the growth endpoint was relatively sensitive for AFB1 toxic effects, and the reproduction endpoint was more sensitive for toxicities of AFB1, FB1, and ZEA. Moreover, the lifespan endpoint was sensitive to toxic effects of all five tested mycotoxins. Data obtained from this study may serve as an important contribution to knowledge on assessment of mycotoxin toxic effects, especially for assessing developmental and reproductive toxic effects, using the C. elegans model.

  1. Pollutant threshold concentration determination in marine ecosystems using an ecological interaction endpoint.

    Science.gov (United States)

    Wang, Changyou; Liang, Shengkang; Guo, Wenting; Yu, Hua; Xing, Wenhui

    2015-09-01

    The threshold concentrations of pollutants are determined by extrapolating single-species effect data to community-level effects. This assumes the most sensitive endpoint of the life cycle of individuals and the species sensitivity distribution from single-species toxic effect tests, thus, ignoring the ecological interactions. The uncertainties due to this extrapolation can be partially overcome using the equilibrium point of a customized ecosystem. This method incorporates ecological interactions and integrates the effects on growth, survival, and ingestion into a single effect measure, the equilibrium point excursion in the customized ecosystem, in order to describe the toxic effects on plankton. A case study showed that the threshold concentration of copper calculated with the endpoint of the equilibrium point was 10 μg L(-1), which is significantly different from the threshold calculated with a single-species endpoint. The endpoint calculated using this method provides a more relevant measure of the ecological impact than any single individual-level endpoint. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. A survey of 110 cases of primary hyperparathyroidism in Dr.Shariati Hospital and the results of localizing the adenoma via MIBI scanning

    Directory of Open Access Journals (Sweden)

    Hedayat A

    1998-07-01

    Full Text Available Primary Hyperparathyroidism is a fairly common disease that is much more predominant in females. Treatment is surgery and includes removing the parathyroid adenoma or the hyperplastic parathyroid glands. Considering the difficulty of this operation procedure, localization test are utilized including ultrasound, MRI, CT scan, Thallium-Technesium subtraction scan, MIBI scan and a series of other tests. According to the studies regarding these tests, MIBI scan is superior to all the others. In this survery we have studied 110 primary hyperparathyroidism patients that were operated on in Dr.Shariati Hospital between 1356 and 1376. In order to localize the adenoma ultrasound was used in ten patients, thallium-technesium subtraction scan in 38 patients. MIBI scan in 30 patients and CT scan in 3 patients. The sensitivity of MIBI scan was 86% and its specificity was 100%. In comparison, the sensitivity of thallium-technesium scan was found to be about 65%. Our results show that MIBI scan has had a high degree of sensitivity and specificity in our patients and has shown to be the best localization test. Therefore we suggest this test for the localization of all parathyroid adenomas.

  3. Similar survival of patients with multiple versus single primary melanomas based on Utah Surveillance, Epidemiology, and End Results data (1973-2011).

    Science.gov (United States)

    Grossman, Douglas; Farnham, James M; Hyngstrom, John; Klapperich, Marki E; Secrest, Aaron M; Empey, Sarah; Bowen, Glen M; Wada, David; Andtbacka, Robert H I; Grossmann, Kenneth; Bowles, Tawnya L; Cannon-Albright, Lisa A

    2018-03-01

    Survival data are mixed comparing patients with multiple primary melanomas (MPM) to those with single primary melanomas (SPM). We compared MPM versus SPM patient survival using a matching method that avoids potential biases associated with other analytic approaches. Records of 14,138 individuals obtained from the Surveillance, Epidemiology, and End Results registry of all melanomas diagnosed or treated in Utah between 1973 and 2011 were reviewed. A single matched control patient was selected randomly from the SPM cohort for each MPM patient, with the restriction that they survived at least as long as the interval between the first and second diagnoses for the matched MPM patient. Survival curves (n = 887 for both MPM and SPM groups) without covariates showed a significant survival disadvantage for MPM patients (chi-squared 39.29, P < .001). However, a multivariate Cox proportional hazards model showed no significant survival difference (hazard ratio 1.07, P = .55). Restricting the multivariate analysis to invasive melanomas also showed no significant survival difference (hazard ratio 0.99, P = .96). Breslow depth, ulceration status, and specific cause of death were not available for all patients. Patients with MPM had similar survival times as patients with SPM. Copyright © 2018 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  4. Simultaneous inference of a binary composite endpoint and its components

    DEFF Research Database (Denmark)

    Große Ruse, Mareile; Ritz, Christian; Hothorn, Ludwig A.

    2017-01-01

    is to stack parameter estimates from the different fits and derive their joint asymptotic distribution. Simulations show that the proposed approach comes closer to nominal levels and has comparable or higher power as compared to existing approaches, even for moderate sample sizes (around 100-200 observations......). The method is compared to the gatekeeping approach and results are provided in the Supplementary Material. In two data examples we show how the procedure may be adapted to handle local significance levels specified through a priori given weights....

  5. Versatile Endpoint Storage Security with Trusted Integrity Modules

    DEFF Research Database (Denmark)

    Gonzalez, Javier; Bonnet, Philippe

    2014-01-01

    . To counter such threats, and to remain trustworthy, personal devices should enforce storage security. State-of-the-art storage security solutions rely on hardware protected encryption. They cannot be deployed, as such, on personal devices either because they require additional hardware (e.g., NetApp’s Safe...... system and applications, that guarantee the durability, confidentiality and integrity of a configurable subset of the filesystem data and meta-data. While, we detail our design with the Linux virtual file system, we expect that our results can be applied to a range of different file systems. As Trusted...

  6. Elimination of endpoint-discontinuity artifacts in the analysis of spectra in reciprocal space

    International Nuclear Information System (INIS)

    Yoo, S. D.; Aspnes, D. E.

    2001-01-01

    Reciprocal-space analysis offers several advantages for determining critical point parameters in optical and other spectra, for example the separation of baseline effects, information, and noise in low-, medium-, and high-index Fourier coefficients, respectively. However, endpoint-discontinuity artifacts can obscure much of the information when segments are isolated for analysis. We developed a procedure for eliminating these artifacts and recovering buried information by minimizing in the white-noise region the mean-square deviation between the Fourier coefficients of the data and those of low-order polynomials, then subtracting the resulting coefficients from the data over the entire range. We find that spectral analysis is optimized if no false data are used, i.e., when the number of points transformed equals the number of actual data points in the segment. Using fractional differentiation we develop a simple derivation of the variation of the reciprocal-space coefficients with index n for Lorentzian and Gaussian line shapes in direct space. More generally, we show that the definition of critical point energies in terms of phase coherence of the Fourier coefficients allows these energies to be determined for a broad class of line shapes even if the direct-space line shapes themselves are not known. Limitations for undersampled or highly broadened spectra are discussed, along with extensions to two- or higher-dimensional arrays of data. [copyright] 2001 American Institute of Physics

  7. Update of the International Consensus on Palliative Radiotherapy Endpoints for Future Clinical Trials in Bone Metastases

    Energy Technology Data Exchange (ETDEWEB)

    Chow, Edward, E-mail: Edward.Chow@sunnybrook.ca [Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON (Canada); Hoskin, Peter [Mount Vernon Centre for Cancer Treatment, Mount Vernon Hospital, Northwood, Middlesex (United Kingdom); Mitera, Gunita; Zeng Liang [Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON (Canada); Lutz, Stephen [Department of Radiation Oncology, Blanchard Valley Regional Cancer Center, Findlay, OH (United States); Roos, Daniel [Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, South Australia (Australia); Hahn, Carol [Department of Radiation Oncology, Duke University Medical Center, Durham, NC (United States); Linden, Yvette van der [Radiotherapeutic Institute Friesland, Leeuwarden (Netherlands); Hartsell, William [Department of Radiation Oncology, Advocate Good Samaritan Cancer Center, Downers Grove, IL (United States); Kumar, Eshwar [Department of Oncology, Atlantic Health Sciences Cancer Centre, Saint John Regional Hospital, Saint John, NB (Canada)

    2012-04-01

    Purpose: To update the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases by surveying international experts regarding previous uncertainties within the 2002 consensus, changes that may be necessary based on practice pattern changes and research findings since that time. Methods and Materials: A two-phase survey was used to determine revisions and new additions to the 2002 consensus. A total of 49 experts from the American Society for Radiation Oncology, the European Society for Therapeutic Radiology and Oncology, the Faculty of Radiation Oncology of the Royal Australian and New Zealand College of Radiologists, and the Canadian Association of Radiation Oncology who are directly involved in the care of patients with bone metastases participated in this survey. Results: Consensus was established in areas involving response definitions, eligibility criteria for future trials, reirradiation, changes in systemic therapy, radiation techniques, parameters at follow-up, and timing of assessments. Conclusion: An outline for trials in bone metastases was updated based on survey and consensus. Investigators leading trials in bone metastases are encouraged to adopt the revised guideline to promote consistent reporting. Areas for future research were identified. It is intended for the consensus to be re-examined in the future on a regular basis.

  8. The interpolation method based on endpoint coordinate for CT three-dimensional image

    International Nuclear Information System (INIS)

    Suto, Yasuzo; Ueno, Shigeru.

    1997-01-01

    Image interpolation is frequently used to improve slice resolution to reach spatial resolution. Improved quality of reconstructed three-dimensional images can be attained with this technique as a result. Linear interpolation is a well-known and widely used method. The distance-image method, which is a non-linear interpolation technique, is also used to convert CT value images to distance images. This paper describes a newly developed method that makes use of end-point coordinates: CT-value images are initially converted to binary images by thresholding them and then sequences of pixels with 1-value are arranged in vertical or horizontal directions. A sequence of pixels with 1-value is defined as a line segment which has starting and end points. For each pair of adjacent line segments, another line segment was composed by spatial interpolation of the start and end points. Binary slice images are constructed from the composed line segments. Three-dimensional images were reconstructed from clinical X-ray CT images, using three different interpolation methods and their quality and processing speed were evaluated and compared. (author)

  9. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials

    DEFF Research Database (Denmark)

    Bottomley, Andrew; Pe, Madeline; Sloan, Jeff

    2016-01-01

    Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are anal......Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures...... are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient......-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes...

  10. Update of the International Consensus on Palliative Radiotherapy Endpoints for Future Clinical Trials in Bone Metastases

    International Nuclear Information System (INIS)

    Chow, Edward; Hoskin, Peter; Mitera, Gunita; Zeng Liang; Lutz, Stephen; Roos, Daniel; Hahn, Carol; Linden, Yvette van der; Hartsell, William; Kumar, Eshwar

    2012-01-01

    Purpose: To update the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases by surveying international experts regarding previous uncertainties within the 2002 consensus, changes that may be necessary based on practice pattern changes and research findings since that time. Methods and Materials: A two-phase survey was used to determine revisions and new additions to the 2002 consensus. A total of 49 experts from the American Society for Radiation Oncology, the European Society for Therapeutic Radiology and Oncology, the Faculty of Radiation Oncology of the Royal Australian and New Zealand College of Radiologists, and the Canadian Association of Radiation Oncology who are directly involved in the care of patients with bone metastases participated in this survey. Results: Consensus was established in areas involving response definitions, eligibility criteria for future trials, reirradiation, changes in systemic therapy, radiation techniques, parameters at follow-up, and timing of assessments. Conclusion: An outline for trials in bone metastases was updated based on survey and consensus. Investigators leading trials in bone metastases are encouraged to adopt the revised guideline to promote consistent reporting. Areas for future research were identified. It is intended for the consensus to be re-examined in the future on a regular basis.

  11. Fear based Education or Curiosity based Education as an Example of Earthquake and Natural Disaster Education: Results of Statistical Study in Primary Schools in Istanbul-Turkey

    Science.gov (United States)

    Ozcep, T.; Ozcep, F.

    2012-04-01

    Natural disaster reduction focuses on the urgent need for prevention activities to reduce loss of life, damage to property, infrastructure and environment, and the social and economic disruption caused by natural hazards. One of the most important factors in reduction of the potential damage of earthquakes is trained manpower. To understanding the causes of earthquakes and other natural phenomena (landslides, avalanches, floods, volcanoes, etc.) is one of the pre-conditions to show a conscious behavior. The aim of the study is to analysis and to investigate, how earthquakes and other natural phenomena are perceived by the students and the possible consequences of this perception, and their effects of reducing earthquake damage. One of the crucial questions is that is our education system fear or curiosity based education system? Effects of the damages due to earthquakes have led to look like a fear subject. In fact, due to the results of the effects, the earthquakes are perceived scary phenomena. In the first stage of the project, the learning (or perception) levels of earthquakes and other natural disasters for the students of primary school are investigated with a survey. Aim of this survey study of earthquakes and other natural phenomena is that have the students fear based or curiosity based approaching to the earthquakes and other natural events. In the second stage of the project, the path obtained by the survey are evaluated with the statistical point of approach. A questionnaire associated with earthquakes and natural disasters are applied to primary school students (that total number of them is approximately 700 pupils) to measure the curiosity and/or fear levels. The questionnaire consists of 17 questions related to natural disasters. The questions are: "What is the Earthquake ?", "What is power behind earthquake?", "What is the mental response during the earthquake ?", "Did we take lesson from earthquake's results ?", "Are you afraid of earthquake

  12. The effect of adherence to statin therapy on cardiovascular mortality: quantification of unmeasured bias using falsification end-points

    Directory of Open Access Journals (Sweden)

    Maarten J. Bijlsma

    2016-04-01

    Full Text Available Abstract Background To determine the clinical effectiveness of statins on cardiovascular mortality in practice, observational studies are needed. Control for confounding is essential in any observational study. Falsification end-points may be useful to determine if bias is present after adjustment has taken place. Methods We followed starters on statin therapy in the Netherlands aged 46 to 100 years over the period 1996 to 2012, from initiation of statin therapy until cardiovascular mortality or censoring. Within this group (n = 49,688, up to 16 years of follow-up, we estimated the effect of adherence to statin therapy (0 = completely non-adherent, 1 = fully adherent on ischemic heart diseases and cerebrovascular disease (ICD10-codes I20-I25 and I60-I69 as well as respiratory and endocrine disease mortality (ICD10-codes J00-J99 and E00-E90 as falsification end points, controlling for demographic factors, socio-economic factors, birth cohort, adherence to other cardiovascular medications, and diabetes using time-varying Cox regression models. Results Falsification end-points indicated that a simpler model was less biased than a model with more controls. Adherence to statins appeared to be protective against cardiovascular mortality (HR: 0.70, 95 % CI 0.61 to 0.81. Conclusions Falsification end-points helped detect overadjustment bias or bias due to competing risks, and thereby proved to be a useful technique in such a complex setting.

  13. Health Endpoint Attributed to Sulfur Dioxide Air Pollutants

    Directory of Open Access Journals (Sweden)

    Geravandi

    2015-07-01

    Full Text Available Background Sulfur dioxide is a colorless gas, released from burning of coal, high-sulfur coal,s and diesel fuel. Sulfur dioxide harms human health by reacting with the moisture in the nose, nasal cavity and throat and this is the way by which it destroys the nerves in the respiratory system. Objectives The aim of this study was to focus on identifying the effects associated with sulfur dioxide on health in Ahvaz, Iran. Materials and Methods Data collections were performed by Ahvaz meteorological organization and the department of environment. Sampling was performed for 24 hours in four stations. Methods of sampling and analysis were according to US environmental protection agency (EPA guideline. Afterwards, we processed the raw data including instruction set correction of averaging, coding and filtering by Excel software and then, the impact of meteorological parameters were converted as the input file to the AirQ model. Finally, we calculated the health effects of exposure to sulfur dioxide. Results According to the findings, the concentration of sulfur dioxide in Ahvaz had an annual average of 51 μg/m3. Sum of the numbers of hospital admissions for respiratory diseases attributed to sulfur dioxide was 25 cases in 2012. Approximately, 5% of the total hospital admissions for respiratory disease and respiratory mortality happened when sulfur dioxide concentration was more than 10 mg/m3. Conclusions According to the results of this study, this increase could be due to higher fuel consumption, usage of gasoline in vehicles, oil industry, and steel and heavy industries in Ahwaz. The risk of mortality and morbidity were detected at the current concentrations of air pollutants.

  14. Meeting report: Measuring endocrine-sensitive endpoints within the first years of life

    DEFF Research Database (Denmark)

    Arbuckle, T.E.; Hauser, R.; Swan, S.H.

    2008-01-01

    An international workshop tided "Assessing Endocrine-Related Endpoints within the First Years of Life" was held 30 April-1 May 2007, in Ottawa, Ontario, Canada. Representatives from a number of pregnancy cohort studies in North America and Europe presented options for measuring various endocrine......-sensitive endpoints in early life and discussed issues related to performing and using those measures. The workshop focused on measuring reproductive tract developmental endpoints [e.g., anogenital distance (AGD)], endocrine status, and infant anthropometry. To the extent possible, workshop participants strove...... on the genital exam. Although a number of outcome measures recommended during the genital exam have been associated with exposure to endocrine-disrupting chemicals, little is known about how predictive these effects are of later reproductive health or other chronic health conditions....

  15. Deep inelastic scattering near the endpoint in soft-collinear effective theory

    International Nuclear Information System (INIS)

    Chay, Junegone; Kim, Chul

    2007-01-01

    We apply the soft-collinear effective theory to deep inelastic scattering near the endpoint region. The forward scattering amplitude and the structure functions are shown to factorize as a convolution of the Wilson coefficients, the jet functions, and the parton distribution functions. The behavior of the parton distribution functions near the endpoint region is considered. It turns out that it evolves with the Altarelli-Parisi kernel even in the endpoint region, and the parton distribution function can be factorized further into a collinear part and the soft Wilson line. The factorized form for the structure functions is obtained by the two-step matching, and the radiative corrections or the evolution for each factorized part can be computed in perturbation theory. We present the radiative corrections of each factorized part to leading order in α s , including the zero-bin subtraction for the collinear part

  16. Implementation of minimally invasive and objective humane endpoints in the study of murine Plasmodium infections

    DEFF Research Database (Denmark)

    Dellavalle, B; Kirchhoff, J; Maretty, L

    2014-01-01

    SUMMARY Defining appropriate and objective endpoints for animal research can be difficult. Previously we evaluated and implemented a body temperature (BT) of ECM) and were interested in a similar endpoint for a model of severe malarial...... anaemia (SMA). Furthermore, we investigate the potential of a minimally invasive, non-contact infrared thermometer for repeated BT measurement. ECM was induced with Plasmodium berghei ANKA infection in C57Bl/6 mice. SMA was induced with Plasmodium chabaudi AS infection in A/J mice. Our previous published...... endpoint was applied in ECM and 30 °C was pre-determined as the lowest permitted limit for termination in SMA according to consultation with the Danish Animal Inspectorate. Infrared thermometer was compared with the rectal probe after cervical dislocation, ECM and SMA. Linear regression analysis of rectal...

  17. Improvement in latent variable indirect response modeling of multiple categorical clinical endpoints: application to modeling of guselkumab treatment effects in psoriatic patients.

    Science.gov (United States)

    Hu, Chuanpu; Randazzo, Bruce; Sharma, Amarnath; Zhou, Honghui

    2017-10-01

    Exposure-response modeling plays an important role in optimizing dose and dosing regimens during clinical drug development. The modeling of multiple endpoints is made possible in part by recent progress in latent variable indirect response (IDR) modeling for ordered categorical endpoints. This manuscript aims to investigate the level of improvement achievable by jointly modeling two such endpoints in the latent variable IDR modeling framework through the sharing of model parameters. This is illustrated with an application to the exposure-response of guselkumab, a human IgG1 monoclonal antibody in clinical development that blocks IL-23. A Phase 2b study was conducted in 238 patients with psoriasis for which disease severity was assessed using Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA) scores. A latent variable Type I IDR model was developed to evaluate the therapeutic effect of guselkumab dosing on 75, 90 and 100% improvement of PASI scores from baseline and PGA scores, with placebo effect empirically modeled. The results showed that the joint model is able to describe the observed data better with fewer parameters compared with the common approach of separately modeling the endpoints.

  18. Are perfluoroalkyl acids in waste water treatment plant effluents the result of primary emissions from the technosphere or of environmental recirculation?

    Science.gov (United States)

    Filipovic, Marko; Berger, Urs

    2015-06-01

    Wastewater treatment plants (WWTP) have been suggested to be one of the major pathways of perfluoroalkyl acids (PFAAs) from the technosphere to the aquatic environment. The origin of PFAAs in WWTP influents is either from current primary emissions or a result of recirculation of PFAAs that have been residing and transported in the environment for several years or decades. Environmental recirculation can then occur when PFAAs from the environment enter the wastewater stream in, e.g., tap water. In this study 13 PFAAs and perfluorooctane sulfonamide were analyzed in tap water as well as WWTP influent, effluent and sludge from three Swedish cities: Bromma (in the metropolitan area of Stockholm), Bollebygd and Umeå. A mass balance of the WWTPs was assembled for each PFAA. Positive mass balances were observed for PFHxA and PFOA in all WWTPs, indicating the presence of precursor compounds in the technosphere. With regard to environmental recirculation, tap water was an important source of PFAAs to the Bromma WWTP influent, contributing >40% for each quantified sulfonic acid and up to 30% for the carboxylic acids. The PFAAs in tap water from Bollebygd and Umeå did not contribute significantly to the PFAA load in the WWTP influents. Our results show that in order to estimate current primary emissions from the technosphere, it may be necessary to correct the PFAA emission rates in WWTP effluents for PFAAs present in tap water, especially in the case of elevated levels in tap water. Copyright © 2014 Elsevier Ltd. All rights reserved.

  19. Effects of un-ionized ammonia on histological, endocrine, and whole organism endpoints in slimy sculpin (Cottus cognatus)

    Energy Technology Data Exchange (ETDEWEB)

    Spencer, P. [Toxicology Centre, University of Saskatchewan, 44 Campus Drive, Saskatoon, SK, S7N 5B3 (Canada)], E-mail: paula.spencer@usask.ca; Pollock, R.; Dube, M. [Toxicology Centre, University of Saskatchewan, 44 Campus Drive, Saskatoon, SK, S7N 5B3 (Canada)

    2008-12-11

    Ammonia is known to be an important toxicant in aquatic environments. Although ammonia toxicity has been well studied in many fish species, effects of chronic exposure on slimy sculpin (Cottus cognatus), a critical biomonitoring species for northern aquatic habitats, are not well known. Further, with increasing mining development in Canada's north, this information is critical to better predict potential effects of mine effluent discharges on northern fish species. Slimy sculpin were exposed to six concentrations of un-ionized ammonia (NH{sub 3}) relevant to concentrations found in northern mining effluents: control (0 ppm), 0.278 ppm, 0.556 ppm, 0.834 ppm, 1.112 ppm, and 1.668 ppm. An LC{sub 50} of 1.529 ppm was calculated from mortality data. Histopathological examination of gills indicated significant tissue damage, measured as lamellar fusion and epithelial lifting, at 0.834 ppm, 1.112 ppm, and 1.668 ppm. Using gill endpoints, NOEC and LOEC were calculated as 0.556 ppm and 0.834 ppm, respectively. An EC{sub 50} of 0.775 ppm was determined for lamellar fusion and an EC{sub 50} of 0.842 ppm for epithelial lifting. Hemorrhage of gills was present in mortalities, which occurred at 1.668 ppm of un-ionized ammonia. A significant decrease in liver somatic index (LSI) was seen in both male and female fish at 0.834 ppm and 1.112 ppm, respectively. Gonadosomatic index (GSI) in female fish significantly increased at 1.668 ppm un-ionized ammonia with an associated significant increase in total wholebody testosterone concentrations. GSI in male fish also significantly increased at 1.668 ppm but no differences were seen in testosterone concentrations. No significant differences were seen in gonad histopathological assessments or condition factor. Gill histopathology endpoints may be a more sensitive indicator for detecting effects in slimy sculpin exposed to ammonia than traditional chronic endpoints. Results from this study indicate that ammonia concentrations commonly

  20. A duplex endpoint PCR assay for rapid detection and differentiation of Leptospira strains.

    Science.gov (United States)

    Benacer, Douadi; Zain, Siti Nursheena Mohd; Lewis, John W; Khalid, Mohd Khairul Nizam Mohd; Thong, Kwai Lin

    2017-01-01

    This study aimed to develop a duplex endpoint PCR assay for rapid detection and differentiation of Leptospira strains. Primers were designed to target the rrs (LG1/LG2) and ligB (LP1/LP2) genes to confirm the presence of the Leptospira genus and the pathogenic species, respectively. The assay showed 100% specificity against 17 Leptospira strains with a limit of detection of 23.1pg/µl of leptospiral DNA and sensitivity of 103 leptospires/ml in both spiked urine and water. Our duplex endpoint PCR assay is suitable for rapid early detection of Leptospira with high sensitivity and specificity.

  1. Comparison of methods for accurate end-point detection of potentiometric titrations

    International Nuclear Information System (INIS)

    Villela, R L A; Borges, P P; Vyskočil, L

    2015-01-01

    Detection of the end point in potentiometric titrations has wide application on experiments that demand very low measurement uncertainties mainly for certifying reference materials. Simulations of experimental coulometric titration data and consequential error analysis of the end-point values were conducted using a programming code. These simulations revealed that the Levenberg-Marquardt method is in general more accurate than the traditional second derivative technique used currently as end-point detection for potentiometric titrations. Performance of the methods will be compared and presented in this paper

  2. Comparison of methods for accurate end-point detection of potentiometric titrations

    Science.gov (United States)

    Villela, R. L. A.; Borges, P. P.; Vyskočil, L.

    2015-01-01

    Detection of the end point in potentiometric titrations has wide application on experiments that demand very low measurement uncertainties mainly for certifying reference materials. Simulations of experimental coulometric titration data and consequential error analysis of the end-point values were conducted using a programming code. These simulations revealed that the Levenberg-Marquardt method is in general more accurate than the traditional second derivative technique used currently as end-point detection for potentiometric titrations. Performance of the methods will be compared and presented in this paper.

  3. Verifying Elimination Programs with a Special Emphasis on Cysticercosis Endpoints and Postelimination Surveillance

    Directory of Open Access Journals (Sweden)

    Sukwan Handali

    2012-01-01

    Full Text Available Methods are needed for determining program endpoints or postprogram surveillance for any elimination program. Cysticercosis has the necessary effective strategies and diagnostic tools for establishing an elimination program; however, tools to verify program endpoints have not been determined. Using a statistical approach, the present study proposed that taeniasis and porcine cysticercosis antibody assays could be used to determine with a high statistical confidence whether an area is free of disease. Confidence would be improved by using secondary tests such as the taeniasis coproantigen assay and necropsy of the sentinel pigs.

  4. Cancer Survivorship Care Plan Utilization and Impact on Clinical Decision-Making at Point-of-Care Visits with Primary Care: Results from an Engineering, Primary Care, and Oncology Collaborative for Survivorship Health.

    Science.gov (United States)

    Donohue, SarahMaria; Haine, James E; Li, Zhanhai; Feldstein, David A; Micek, Mark; Trowbridge, Elizabeth R; Kamnetz, Sandra A; Sosman, James M; Wilke, Lee G; Sesto, Mary E; Tevaarwerk, Amye J

    2017-11-02

    Every cancer survivor and his/her primary care provider should receive an individualized survivorship care plan (SCP) following curative treatment. Little is known regarding point-of-care utilization at primary care visits. We assessed SCP utilization in the clinical context of primary care visits. Primary care physicians and advanced practice providers (APPs) who had seen survivors following provision of an SCP were identified. Eligible primary care physicians and APPs were sent an online survey, evaluating SCP utilization and influence on decision-making at the point-of-care, accompanied by copies of the survivor's SCP and the clinic note. Eighty-eight primary care physicians and APPs were surveyed November 2016, with 40 (45%) responding. Most respondents (60%) reported discussing cancer or related issues during the visit. Information needed included treatment (66%) and follow-up visits, and the cancer team was responsible for (58%) vs primary care (58%). Respondents acquired this information by asking the patient (79%), checking oncology notes (75%), the SCP (17%), or online resources (8%). Barriers to SCP use included being unaware of the SCP (73%), difficulty locating it (30%), and finding needed information faster via another mechanism (15%). Despite largely not using the SCP for the visit (90%), most respondents (61%) believed one would be quite or very helpful for future visits. Most primary care visits included discussion of cancer or cancer-related issues. SCPs may provide the information necessary to deliver optimal survivor care but efforts are needed to reduce barriers and design SCPs for primary care use.

  5. Neutralization Assay for Zika and Dengue Viruses by Use of Real-Time-PCR-Based Endpoint Assessment.

    Science.gov (United States)

    Wilson, Heather L; Tran, Thomas; Druce, Julian; Dupont-Rouzeyrol, Myrielle; Catton, Michael

    2017-10-01

    The global spread and infective complications of Zika virus (ZKV) and dengue virus (DENV) have made them flaviviruses of public health concern. Serological diagnosis can be challenging due to antibody cross-reactivity, particularly in secondary flavivirus infections or when there is a history of flavivirus vaccination. The virus neutralization assay is considered to be the most specific assay for measurement of anti-flavivirus antibodies. This study describes an assay where the neutralization endpoint is measured by real-time PCR, providing results within 72 h. It demonstrated 100% sensitivity (24/24 ZKV and 15/15 DENV) and 100% specificity (11/11 specimens) when testing well-characterized sera. In addition, the assay was able to determine the correct DENV serotype in 91.7% of cases. The high sensitivity and specificity of the real-time PCR neutralization assay makes it suitable to use as a confirmatory test for sera that are reactive in commercial IgM/IgG enzyme immunoassays. Results are objective and the PCR-based measurement of the neutralization endpoint lends itself to automation so that throughput may be increased in times of high demand. Copyright © 2017 American Society for Microbiology.

  6. Allergenicity evaluation of fragrance mix and its ingredients by using ex vivo local lymph node assay-BrdU endpoints.

    Science.gov (United States)

    Ulker, Ozge Cemiloglu; Kaymak, Yesim; Karakaya, Asuman

    2014-03-01

    The present studies were performed to compare the differences between sensitization potency of fragrance mix and its ingredients (oak moss absolute, isoeugenol, eugenol, cinnamal, hydroxycitronellal, geraniol, cinnamic alcohol, alpha amyl cinnamal), by using ex vivo LLNA-BrdU ELISA. The SI and EC3 values were calculated and potency classification was found for the mixture and for each ingredients. TH1 cytokines (IL-2, IFN-γ) and TH2 cytokines (IL-4, IL-5) releases from lymph node cell culture were also investigated as contact sensitization endpoints. The EC3 values were calculated and the potency of contact sensitization were classified for fragrance mix, oak moss absolute, isoeugenol, eugenol, cinnamal, hydroxycitronellal, geraniol, cinnamic alcohol, alpha amyl cinnamal respectively: 4.4% (moderate), 3.4% (moderate), 0.88% (strong), 16.6% (weak), 1.91% (moderate), 9.77% (moderate), 13.1% (weak), 17.93% (weak), 7.74% (moderate). According to our results it should be concluded that exposure to fragrance mix does not constitute an evidently increased hazard compared to exposure to each of the eight fragrance ingredients separately. Cytokine analyses results indicate that both TH1 and TH2 cytokines are involved in the regulation of murine contact allergy and can be considered as useful endpoints. Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. Testing of an End-Point Control Unit Designed to Enable Precision Control of Manipulator-Coupled Spacecraft

    Science.gov (United States)

    Montgomery, Raymond C.; Ghosh, Dave; Tobbe, Patrick A.; Weathers, John M.; Manouchehri, Davoud; Lindsay, Thomas S.

    1994-01-01

    This paper presents an end-point control concept designed to enable precision telerobotic control of manipulator-coupled spacecraft. The concept employs a hardware unit (end-point control unit EPCU) that is positioned between the end-effector of the Space Shuttle Remote Manipulator System and the payload. Features of the unit are active compliance (control of the displacement between the end-effector and the payload), to allow precision control of payload motions, and inertial load relief, to prevent the transmission of loads between the end-effector and the payload. This paper presents the concept and studies the active compliance feature using a simulation and hardware. Results of the simulation show the effectiveness of the EPCU in smoothing the motion of the payload. Results are presented from initial, limited tests of a laboratory hardware unit on a robotic arm testbed at the l Space Flight Center. Tracking performance of the arm in a constant speed automated retraction and extension maneuver of a heavy payload with and without the unit active is compared for the design speed and higher speeds. Simultaneous load reduction and tracking performance are demonstrated using the EPCU.

  8. Evaluation of biological endpoints in crop plants after exposure to non-steroidal anti-inflammatory drugs (NSAIDs): implications for phytotoxicological assessment of novel contaminants.

    Science.gov (United States)

    Schmidt, Wiebke; Redshaw, Clare H

    2015-02-01

    Human pharmaceuticals have been detected in the terrestrial environment at µg to mg kg(-1) concentrations. Repeated application of sewage sludge (biosolids) and increasing reclaimed wastewater use for irrigation could lead to accumulation of these novel contaminants in soil systems. Despite this, potential phytotoxicological effects on higher plants have rarely been evaluated. These studies aimed to test effects upon germination, development, growth and physiology of two crop plants, namely radish (Raphanus sativus Spakler 3) and lettuce (Lactuca sativa All Year Around), after exposure to different, but structurally related non-steroidal anti-inflammatory drugs (NSAIDs) at environmentally relevant concentrations. A range of biological endpoints comprising biomass, length, water content, specific root and shoot length, root to shoot ratio, daily progress of stages of cell elongation and organ emergence (primary root, hypocotyl elongation, cotyledon emergence, cotyledon opening, and no change), as well as photosynthetic measurements were evaluated. Compounds from the fenamic acid class were found to affect R. sativus root endpoints (root length and water content), while ibuprofen affected early root development of L. sativa. In general, phytotoxicological effects on root endpoints demonstrated that impacts upon higher plants are not only compound specific, but also differ between plant species. It was found that the usage of a wide range of biological endpoints (all simple, cost-effective and ecologically relevant) were beneficial in detecting differences in plant responses to NSAID exposure. Due to paucity and discrepancy within the few previously available phytotoxicological studies with pharmaceuticals, it is now essential to allocate time and resources to consider development of suitable chronic toxicity tests, and some suggestions regarding this are presented. Copyright © 2014 Elsevier Inc. All rights reserved.

  9. The Effect of Primary Cancer Cell Culture Models on the Results of Drug Chemosensitivity Assays: The Application of Perfusion Microbioreactor System as Cell Culture Vessel

    Science.gov (United States)

    Chen, Yi-Dao; Huang, Shiang-Fu; Wang, Hung-Ming

    2015-01-01

    To precisely and faithfully perform cell-based drug chemosensitivity assays, a well-defined and biologically relevant culture condition is required. For the former, a perfusion microbioreactor system capable of providing a stable culture condition was adopted. For the latter, however, little is known about the impact of culture models on the physiology and chemosensitivity assay results of primary oral cavity cancer cells. To address the issues, experiments were performed. Results showed that minor environmental pH change could significantly affect the metabolic activity of cells, demonstrating the importance of stable culture condition for such assays. Moreover, the culture models could also significantly influence the metabolic activity and proliferation of cells. Furthermore, the choice of culture models might lead to different outcomes of chemosensitivity assays. Compared with the similar test based on tumor-level assays, the spheroid model could overestimate the drug resistance of cells to cisplatin, whereas the 2D and 3D culture models might overestimate the chemosensitivity of cells to such anticancer drug. In this study, the 3D culture models with same cell density as that in tumor samples showed comparable chemosensitivity assay results as the tumor-level assays. Overall, this study has provided some fundamental information for establishing a precise and faithful drug chemosensitivity assay. PMID:25654105

  10. SU-D-204-01: A Methodology Based On Machine Learning and Quantum Clustering to Predict Lung SBRT Dosimetric Endpoints From Patient Specific Anatomic Features

    Energy Technology Data Exchange (ETDEWEB)

    Lafata, K; Ren, L; Wu, Q; Kelsey, C; Hong, J; Cai, J; Yin, F [Duke University Medical Center, Durham, NC (United States)

    2016-06-15

    Purpose: To develop a data-mining methodology based on quantum clustering and machine learning to predict expected dosimetric endpoints for lung SBRT applications based on patient-specific anatomic features. Methods: Ninety-three patients who received lung SBRT at our clinic from 2011–2013 were retrospectively identified. Planning information was acquired for each patient, from which various features were extracted using in-house semi-automatic software. Anatomic features included tumor-to-OAR distances, tumor location, total-lung-volume, GTV and ITV. Dosimetric endpoints were adopted from RTOG-0195 recommendations, and consisted of various OAR-specific partial-volume doses and maximum point-doses. First, PCA analysis and unsupervised quantum-clustering was used to explore the feature-space to identify potentially strong classifiers. Secondly, a multi-class logistic regression algorithm was developed and trained to predict dose-volume endpoints based on patient-specific anatomic features. Classes were defined by discretizing the dose-volume data, and the feature-space was zero-mean normalized. Fitting parameters were determined by minimizing a regularized cost function, and optimization was performed via gradient descent. As a pilot study, the model was tested on two esophageal dosimetric planning endpoints (maximum point-dose, dose-to-5cc), and its generalizability was evaluated with leave-one-out cross-validation. Results: Quantum-Clustering demonstrated a strong separation of feature-space at 15Gy across the first-and-second Principle Components of the data when the dosimetric endpoints were retrospectively identified. Maximum point dose prediction to the esophagus demonstrated a cross-validation accuracy of 87%, and the maximum dose to 5cc demonstrated a respective value of 79%. The largest optimized weighting factor was placed on GTV-to-esophagus distance (a factor of 10 greater than the second largest weighting factor), indicating an intuitively strong

  11. Primary clear cell renal carcinoma cells display minimal mitochondrial respiratory capacity resulting in pronounced sensitivity to glycolytic inhibition by 3-Bromopyruvate.

    Science.gov (United States)

    Nilsson, H; Lindgren, D; Mandahl Forsberg, A; Mulder, H; Axelson, H; Johansson, M E

    2015-01-08

    Changes of cellular metabolism are an integral property of the malignant potential of most cancer cells. Already in the 1930s, Otto Warburg observed that tumor cells preferably utilize glycolysis and lactate fermentation for energy production, rather than the mitochondrial oxidative phosphorylation dominating in normal cells, a phenomenon today known as the Warburg effect. Even though many tumor types display a high degree of aerobic glycolysis, they still retain the activity of other energy-producing metabolic pathways. One exception seems to be the clear cell variant of renal cell carcinoma, ccRCC, where the activity of most other pathways than that of glycolysis has been shown to be reduced. This makes ccRCC a promising candidate for the use of glycolytic inhibitors in treatment of the disease. However, few studies have so far addressed this issue. In this report, we show a strikingly reduced mitochondrial respiratory capacity of primary human ccRCC cells, resulting in enhanced sensitivity to glycolytic inhibition by 3-Bromopyruvate (3BrPA). This effect was largely absent in established ccRCC cell lines, a finding that highlights the importance of using biologically relevant models in the search for new candidate cancer therapies. 3BrPA markedly reduced ATP production in primary ccRCC cells, followed by cell death. Our data suggest that glycolytic inhibitors such as 3BrPA, that has been shown to be well tolerated in vivo, should be further analyzed for the possible development of selective treatment strategies for patients with ccRCC.

  12. Preliminary results following the use of a fixed combination of timolol–brimonidine in patients with ocular hypertension and primary open-angle glaucoma

    Directory of Open Access Journals (Sweden)

    Dimitris Papaconstantinou

    2009-03-01

    Full Text Available Dimitris Papaconstantinou1, Ilias Georgalas2, Nikolaos Kourtis1, Christos Pitsas1, Efthimios Karmiris1, Chrysanthi Koutsandrea1, Ioannis Ladas1, Gerasimos Georgopoulos11Department of Ophthalmology, “G Gennimatas” Hospital of Athens, University of Athens, Athens, Greece; 2Department of Ophthalmology, “G Gennimatas” Hospital of Athens, NHS, Athens, Greece Purpose: The purpose of this prospective study was to evaluate the efficacy in intraocular pressure (IOP control and the tolerance of a topically administered fixed combination of timolol–brimonidine in 50 patients with ocular hypertension and primary open-angle glaucoma.Methods: After determining a baseline IOP, the fixed combination timolol–brimonidine was used twice daily for two months, while IOP, ophthalmic signs, and/or symptoms were monitored.Results: The mean IOP value was decreased from 23.09 mm Hg (±1.98 SD to 17.46 mm Hg (±1.47 SD during the 1st month (paired Student’s t test = 9.88 και p < 0.001, and to 17.51 mm Hg (±1.43 SD in the 2nd month. Between the 1st and 2nd month, no statistical difference was observed (paired Student’s t test = 0.02 και p < 0.1. In 8% of the patients during the 1st month and 10% of patients in the 2nd month, some ophthalmic signs were observed, while only mild ophthalmic symptoms were reported in 6% and 8% of the patients, respectively.Conclusions: In conclusion, the fixed combination of timolol–brimonidine has a satisfactory IOP-lowering effect without any serious side effects due to the topical use. Keywords: fixed combination 0.2% brimonidine–0.5% timolol, ocular hypertension, primary open-angle glaucoma

  13. Does Local Recurrence of Prostate Cancer After Radiation Therapy Occur at the Site of Primary Tumor? Results of a Longitudinal MRI and MRSI Study

    International Nuclear Information System (INIS)

    Arrayeh, Elnasif; Westphalen, Antonio C.; Kurhanewicz, John; Roach, Mack; Jung, Adam J.; Carroll, Peter R.; Coakley, Fergus V.

    2012-01-01

    Purpose: To determine if local recurrence of prostate cancer after radiation therapy occurs at the same site as the primary tumor before treatment, using longitudinal magnetic resonance (MR) imaging and MR spectroscopic imaging to assess dominant tumor location. Methods and Materials: This retrospective study was HIPAA compliant and approved by our Committee on Human Research. We identified all patients in our institutional prostate cancer database (1996 onward) who underwent endorectal MR imaging and MR spectroscopic imaging before radiotherapy for biopsy-proven prostate cancer and again at least 2 years after radiotherapy (n = 124). Two radiologists recorded the presence, location, and size of unequivocal dominant tumor on pre- and postradiotherapy scans. Recurrent tumor was considered to be at the same location as the baseline tumor if at least 50% of the tumor location overlapped. Clinical and biopsy data were collected from all patients. Results: Nine patients had unequivocal dominant tumor on both pre- and postradiotherapy imaging, with mean pre- and postradiotherapy dominant tumor diameters of 1.8 cm (range, 1–2.2) and 1.9 cm (range, 1.4–2.6), respectively. The median follow-up interval was 7.3 years (range, 2.7–10.8). Dominant recurrent tumor was at the same location as dominant baseline tumor in 8 of 9 patients (89%). Conclusions: Local recurrence of prostate cancer after radiation usually occurs at the same site as the dominant primary tumor at baseline, suggesting supplementary focal therapy aimed at enhancing local tumor control would be a rational addition to management.

  14. How do primary care doctors in England and Wales code and manage people with chronic kidney disease? Results from the National Chronic Kidney Disease Audit.

    Science.gov (United States)

    Kim, Lois G; Cleary, Faye; Wheeler, David C; Caplin, Ben; Nitsch, Dorothea; Hull, Sally A

    2017-10-16

    In the UK, primary care records are electronic and require doctors to ascribe disease codes to direct care plans and facilitate safe prescribing. We investigated factors associated with coding of chronic kidney disease (CKD) in patients with reduced kidney function and the impact this has on patient management. We identified patients meeting biochemical criteria for CKD (two estimated glomerular filtration rates 90 days apart) from 1039 general practitioner (GP) practices in a UK audit. Clustered logistic regression was used to identify factors associated with coding for CKD and improvement in coding as a result of the audit process. We investigated the relationship between coding and five interventions recommended for CKD: achieving blood pressure targets, proteinuria testing, statin prescription and flu and pneumococcal vaccination. Of 256 000 patients with biochemical CKD, 30% did not have a GP CKD code. Males, older patients, those with more severe CKD, diabetes or hypertension or those prescribed statins were more likely to have a CKD code. Among those with continued biochemical CKD following audit, these same characteristics increased the odds of improved coding. Patients without any kidney diagnosis were less likely to receive optimal care than those coded for CKD [e.g. odds ratio for meeting blood pressure target 0.78 (95% confidence interval 0.76-0.79)]. Older age, male sex, diabetes and hypertension are associated with coding for those with biochemical CKD. CKD coding is associated with receiving key primary care interventions recommended for CKD. Increased efforts to incentivize CKD coding may improve outcomes for CKD patients. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA.

  15. Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients: Primary Results from the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial

    Science.gov (United States)

    Bostom, Andrew G.; Carpenter, Myra A.; Kusek, John W.; Levey, Andrew S.; Hunsicker, Lawrence; Pfeffer, Marc A.; Selhub, Jacob; Jacques, Paul F.; Cole, Edward; Gravens-Mueller, Lisa; House, Andrew A.; Kew, Clifton; McKenney, Joyce L.; Pacheco-Silva, Alvaro; Pesavento, Todd; Pirsch, John; Smith, Stephen; Solomon, Scott; Weir, Matthew

    2015-01-01

    Background Kidney transplant recipients, like other patients with chronic kidney disease (CKD), experience excess risk of cardiovascular disease (CVD) and elevated total homocysteine (tHcy) concentrations. Observational studies of patients with CKD suggest increased homocysteine is a risk factor for CVD. The impact of lowering total homocysteine (tHcy) levels in kidney transplant recipients is unknown. Methods and Results In a double-blind controlled trial, we randomized 4110 stable kidney transplant recipients to a multivitamin that included either a high dose (n=2056) or low dose (n=2054) of folic acid, vitamin B6, and vitamin B12 to determine whether decreasing tHcy concentrations reduced the rate of the primary composite arteriosclerotic CVD outcome (myocardial infarction, stroke, CVD death, resuscitated sudden death, coronary artery or renal artery revascularization, lower extremity arterial disease, carotid endarterectomy or angioplasty, or abdominal aortic aneurysm repair). Mean follow-up was 4.0 years. Treatment with the high dose multivitamin reduced homocysteine but did not reduce the rates of the primary outcome (n= 547 total events; hazards ratio [95% confidence interval] = 0.99 [0.84–1.17]), or secondary outcomes of all-cause mortality (n=431 deaths; 1.04 [0.86–1.26]) or dialysis-dependent kidney failure (n=343 events; 1.15 [0.93–1.43]) compared to the low dose multivitamin. Conclusions Treatment with a high dose folic acid, B6, and B12 multivitamin in kidney transplant recipients did not reduce a composite cardiovascular disease outcome, all-cause mortality, or dialysis-dependent kidney failure despite significant reduction in homocysteine level. PMID:21482964

  16. A Portable Automatic Endpoint Detection System for Amplicons of Loop Mediated Isothermal Amplification on Microfluidic Compact Disk Platform

    Directory of Open Access Journals (Sweden)

    Shah Mukim Uddin

    2015-03-01

    Full Text Available In recent years, many improvements have been made in foodborne pathogen detection methods to reduce the impact of food contamination. Several rapid methods have been developed with biosensor devices to improve the way of performing pathogen detection. This paper presents an automated endpoint detection system for amplicons generated by loop mediated isothermal amplification (LAMP on a microfluidic compact disk platform. The developed detection system utilizes a monochromatic ultraviolet (UV emitter for excitation of fluorescent labeled LAMP amplicons and a color sensor to detect the emitted florescence from target. Then it processes th