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Sample records for label non-comparative multicenter

  1. Homoeopathic management of Schizophrenia: A prospective, non-comparative, open-label observational study

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    Praveen Oberai

    2016-01-01

    Full Text Available Objectives: To evaluate the usefulness of homoeopathic intervention in Schizophrenia, in untreated cases and antipsychotic treatment resistant cases, to verify indications of medicines, and to assess relapse, if any. Materials and Methods: A prospective, non-comparative, open-label observational study was carried out from October 2005-September 2010 by CCRH at Central Research Institute (H, Kottayam, Kerala, India. Patients between 20 and 60 years of age, presenting with symptoms of Schizophrenia were screened for inclusion and exclusion criteria. The patients who were on antipsychotic drugs were allowed to continue the same along with homoeopathic medicine, the dose of antipsychotics was monitored by the Psychiatrist. The symptoms of each patient were repertorized, and medicine was initially prescribed in 30C potency after consulting Materia Medica. Patients were followed up for 12 months. Outcome of treatment was assessed with Brief Psychiatric Rating Scales (BPRS. Analysis was done using Statistical Package for the Social Sciences  SPSS Version 20.0. Results: Out of 188 enrolled patients, 17 cases did not complete the baseline information. Total 171 patients were analysed as per modified Intention to Treat Principle. Significant difference (P = 0.0001, P < 0.05 in the mean scores of BPRS, using paired t test was observed at end of the study. Sulphur, Lycopodium, Natrum muriaticum, Pulsatilla and Phosphorus were found to be the most useful medicines in treating schizophrenic patients. Conclusion: The study reflects the positive role of homoeopathic medicines in the management of patients suffering from schizophrenia as measured by BPRS.

  2. Multicenter, open-label, non-comparative study of a combination of polytar and zinc pyrithione shampoo in the management of dandruff

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    Sawleshwarkar Shailendra

    2004-01-01

    Full Text Available Background: Dandruff is a common condition in clinical practice. We undertook a study to evaluate the efficacy and safety of a combination of zinc pyrithione and polytar in a shampoo base for the treatment of dandruff. Methods: A combination of polytar (1% and zinc pyrithione (1% was used for 4 weeks to treat 954 patients suffering from mild to severe dandruff. Scoring of dandruff was done on a 0-10 scale for each of the 6 regions of scalp at weeks 0, 2, 4 and 6. Follow up was for 2 weeks. Results: There was consistent improvement in dandruff scores over the treatment and the follow up period. There was significant improvement in signs and symptoms such as erythema and itching, with a negligible adverse event profile. The global assessment by investigators showed good-excellent results in the majority of patients and there was high acceptability for the treatment among the patients. Conclusion: A combination shampoo of polytar (1% and zinc pyrithione (1% offers a safe and effective option in the treatment of dandruff and its associated symptoms.

  3. Local Heat Application for the Treatment of Buruli Ulcer: Results of a Phase II Open Label Single Center Non Comparative Clinical Trial.

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    Vogel, Moritz; Bayi, Pierre F; Ruf, Marie-Thérèse; Bratschi, Martin W; Bolz, Miriam; Um Boock, Alphonse; Zwahlen, Marcel; Pluschke, Gerd; Junghanss, Thomas

    2016-02-01

    Buruli ulcer (BU) is a necrotizing skin disease most prevalent among West African children. The causative organism, Mycobacterium ulcerans, is sensitive to temperatures above 37°C. We investigated the safety and efficacy of a local heat application device based on phase change material. In a phase II open label single center noncomparative clinical trial (ISRCTN 72102977) under GCP standards in Cameroon, laboratory confirmed BU patients received up to 8 weeks of heat treatment. We assessed efficacy based on the endpoints 'absence of clinical BU specific features' or 'wound closure' within 6 months ("primary cure"), and 'absence of clinical recurrence within 24 month' ("definite cure"). Of 53 patients 51 (96%) had ulcerative disease. 62% were classified as World Health Organization category II, 19% each as category I and III. The average lesion size was 45 cm(2). Within 6 months after completion of heat treatment 92.4% (49 of 53, 95% confidence interval [CI], 81.8% to 98.0%) achieved cure of their primary lesion. At 24 months follow-up 83.7% (41 of 49, 95% CI, 70.3% to 92.7%) of patients with primary cure remained free of recurrence. Heat treatment was well tolerated; adverse effects were occasional mild local skin reactions. Local thermotherapy is a highly effective, simple, cheap and safe treatment for M. ulcerans disease. It has in particular potential as home-based remedy for BU suspicious lesions at community level where laboratory confirmation is not available. ISRCT 72102977. © The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America.

  4. The QUASAR reproducibility study, Part II: Results from a multi-center Arterial Spin Labeling test-retest study

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    Petersen, Esben Thade; Mouridsen, Kim; Golay, Xavier

    2010-01-01

    Quantitative STAR labeling of Arterial Regions or QUASAR), a method providing user independent quantification of CBF in a large test-retest study across sites from around the world, dubbed "The QUASAR reproducibility study". Altogether, 28 sites located in Asia, Europe and North America participated...... and a total of 284 healthy volunteers were scanned. Minimal operator dependence was assured by using an automatic planning tool and its accuracy and potential usefulness in multi-center trials was evaluated as well. Accurate repositioning between sessions was achieved with the automatic planning tool showing...

  5. The QUASAR reproducibility study, Part II: Results from a multi-center Arterial Spin Labeling test-retest study

    DEFF Research Database (Denmark)

    Petersen, Esben; Mouridsen, Kim; Golay, Xavier

    2009-01-01

    Quantitative STAR labeling of Arterial Regions or QUASAR), a method providing user independent quantification of CBF in a large test-retest study across sites from around the world, dubbed "The QUASAR reproducibility study". Altogether, 28 sites located in Asia, Europe and North America participated...... and a total of 284 healthy volunteers were scanned. Minimal operator dependence was assured by using an automatic planning tool and its accuracy and potential usefulness in multi-center trials was evaluated as well. Accurate repositioning between sessions was achieved with the automatic planning tool showing...

  6. Off-label prescribing patterns of antiemetics in children: a multicenter study in Italy.

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    Zanon, Davide; Gallelli, Luca; Rovere, Francesca; Paparazzo, Rossella; Maximova, Natalia; Lazzerini, Marzia; Reale, Antonio; Corsetti, Tiziana; Renna, Salvatore; Emanueli, Tullia; Mannelli, Francesco; Manteghetti, Francesco; Da Dalt, Liviana; Palleria, Caterina; Banchieri, Nicola; Urbino, Antonio; Miglietta, Mario; Cardoni, Giovanni; Pompilio, Adriana; Arrighini, Alberto; Lazzari, Clara; Messi, Gianni

    2013-03-01

    Acute gastroenteritis (AG) represents both the main cause of acute vomiting in children under 3 years old and a major cause of access to the emergency department. Even if several drugs may be able to reduce the emesis, the pharmacological treatment of vomiting in children remains a controversial issue, and several drugs are prescribed outside their authorized drug label with respect dosage, age, indication, or route of administration and are named as off-label. The aim of present study was to assess the off-label use of antiemetic drugs in patients less than 18 years with vomiting related to AG. This study was carried out in eight pediatric emergency departments in Italy. The following data were obtained crossing the pharmacy distribution records with emergency departments' patient data: sex and age of the patients and detailed information for each drug used (indication, dose, frequency, and route of administration). We recorded that antiemetic drugs were prescribed in every year, particularly in children up to 2 years old, and compared with both literature data and data sheet; 30 % of the administered antiemetics were used off-label. In particular, domperidone was the only antiemetic used labeled for AG treatment in pediatric patients, while metoclopramide and ondansetron have been off-label for both age and indications (i.e., AG treatment). In conclusion, we documented an off-label use of antiemetics in children, and this could represents a problem of safety for the patient and a legal risk for the prescribing physician if patients have an unwanted or bad outcome from treatment.

  7. The QUASAR reproducibility study, Part II: Results from a multi-center Arterial Spin Labeling test-retest study.

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    Petersen, Esben Thade; Mouridsen, Kim; Golay, Xavier

    2010-01-01

    Arterial Spin Labeling (ASL) is a method to measure perfusion using magnetically labeled blood water as an endogenous tracer. Being fully non-invasive, this technique is attractive for longitudinal studies of cerebral blood flow in healthy and diseased individuals, or as a surrogate marker of metabolism. So far, ASL has been restricted mostly to specialist centers due to a generally low SNR of the method and potential issues with user-dependent analysis needed to obtain quantitative measurement of cerebral blood flow (CBF). Here, we evaluated a particular implementation of ASL (called Quantitative STAR labeling of Arterial Regions or QUASAR), a method providing user independent quantification of CBF in a large test-retest study across sites from around the world, dubbed "The QUASAR reproducibility study". Altogether, 28 sites located in Asia, Europe and North America participated and a total of 284 healthy volunteers were scanned. Minimal operator dependence was assured by using an automatic planning tool and its accuracy and potential usefulness in multi-center trials was evaluated as well. Accurate repositioning between sessions was achieved with the automatic planning tool showing mean displacements of 1.87+/-0.95 mm and rotations of 1.56+/-0.66 degrees . Mean gray matter CBF was 47.4+/-7.5 [ml/100 g/min] with a between-subject standard variation SD(b)=5.5 [ml/100 g/min] and a within-subject standard deviation SD(w)=4.7 [ml/100 g/min]. The corresponding repeatability was 13.0 [ml/100 g/min] and was found to be within the range of previous studies.

  8. A multi-center study benchmarks software tools for label-free proteome quantification

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    Gillet, Ludovic C; Bernhardt, Oliver M.; MacLean, Brendan; Röst, Hannes L.; Tate, Stephen A.; Tsou, Chih-Chiang; Reiter, Lukas; Distler, Ute; Rosenberger, George; Perez-Riverol, Yasset; Nesvizhskii, Alexey I.; Aebersold, Ruedi; Tenzer, Stefan

    2016-01-01

    The consistent and accurate quantification of proteins by mass spectrometry (MS)-based proteomics depends on the performance of instruments, acquisition methods and data analysis software. In collaboration with the software developers, we evaluated OpenSWATH, SWATH2.0, Skyline, Spectronaut and DIA-Umpire, five of the most widely used software methods for processing data from SWATH-MS (sequential window acquisition of all theoretical fragment ion spectra), a method that uses data-independent acquisition (DIA) for label-free protein quantification. We analyzed high-complexity test datasets from hybrid proteome samples of defined quantitative composition acquired on two different MS instruments using different SWATH isolation windows setups. For consistent evaluation we developed LFQbench, an R-package to calculate metrics of precision and accuracy in label-free quantitative MS, and report the identification performance, robustness and specificity of each software tool. Our reference datasets enabled developers to improve their software tools. After optimization, all tools provided highly convergent identification and reliable quantification performance, underscoring their robustness for label-free quantitative proteomics. PMID:27701404

  9. A multicenter study benchmarks software tools for label-free proteome quantification.

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    Navarro, Pedro; Kuharev, Jörg; Gillet, Ludovic C; Bernhardt, Oliver M; MacLean, Brendan; Röst, Hannes L; Tate, Stephen A; Tsou, Chih-Chiang; Reiter, Lukas; Distler, Ute; Rosenberger, George; Perez-Riverol, Yasset; Nesvizhskii, Alexey I; Aebersold, Ruedi; Tenzer, Stefan

    2016-11-01

    Consistent and accurate quantification of proteins by mass spectrometry (MS)-based proteomics depends on the performance of instruments, acquisition methods and data analysis software. In collaboration with the software developers, we evaluated OpenSWATH, SWATH 2.0, Skyline, Spectronaut and DIA-Umpire, five of the most widely used software methods for processing data from sequential window acquisition of all theoretical fragment-ion spectra (SWATH)-MS, which uses data-independent acquisition (DIA) for label-free protein quantification. We analyzed high-complexity test data sets from hybrid proteome samples of defined quantitative composition acquired on two different MS instruments using different SWATH isolation-window setups. For consistent evaluation, we developed LFQbench, an R package, to calculate metrics of precision and accuracy in label-free quantitative MS and report the identification performance, robustness and specificity of each software tool. Our reference data sets enabled developers to improve their software tools. After optimization, all tools provided highly convergent identification and reliable quantification performance, underscoring their robustness for label-free quantitative proteomics.

  10. European multicenter study on melanoma immunoscintigraphy by means of 99mTc-labelled monoclonal antibody fragments

    International Nuclear Information System (INIS)

    Siccardi, A.G.; Viale, G.; Natali, P.G.; Scassellati, G.A.; Ferrone, S.

    1990-01-01

    A total of 493 melanoma patients were investigated by 20 European nuclear medicine departments by means of the same 99m Tc-labelled immunoradiopharmaceutical and the same immunoscintigraphy (ISG) protocol. (i) No chemical or clinical toxicity was detected during or following the studies. (ii) Positive results were obtained in 287/363 (79%) patients (321 carrying known lesions and 42 carrying previously occult lesions): In 231 (80%) of them, 402/402 lesions were imaged; in the remaining 56 ISG-positive patients, 108/204 lesions were imaged; in 76 patients 0/122 lesions were imaged. (iii) The fraction of melanoma lesions visualized by ISG was 510/728 (70.1%); 605 of these lesions were already documented at the time of the study, and 123 were previously occult. (iv) A total of 218 documented melanoma lesions (30%) were not visualized by ISG in 132 patients: About 70% of the ISG-negative lesions were of small size (less than 2 cm diameter). (v) The melanoma nature of 69/123 previously occult lesions was confirmed by clinical criteria and/or additional investigations in follow-up studies. The results obtained in this study are similar to those obtained in the Italian Multicenter Study which had previously been carried out with 258 melanoma patients. (orig.)

  11. A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study).

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    Starling, Amaal J; Tepper, Stewart J; Marmura, Michael J; Shamim, Ejaz A; Robbins, Matthew S; Hindiyeh, Nada; Charles, Andrew C; Goadsby, Peter J; Lipton, Richard B; Silberstein, Stephen D; Gelfand, Amy A; Chiacchierini, Richard P; Dodick, David W

    2018-05-01

    Objective To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. Background sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention. Methods The eNeura SpringTMS Post-Market Observational U.S. Study of Migraine (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment. Patients reported daily headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50% responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity. Results Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a -2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (-0.63 days) ( p < 0.0001). The 50% responder rate of 46% (95% CI 37%, 56%) was also significantly higher ( p < 0.0001) than the performance goal (20%). There was a reduction of -2

  12. Essure multicenter off-label treatment for hydrosalpinx before in vitro fertilization.

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    Galen, Donald I; Khan, Naveed; Richter, Kevin S

    2011-01-01

    To estimate the safety and efficacy of Essure placement for proximal tubal occlusion in women with hydrosalpinx before in vitro fertilization (IVF). Prospective 2-center clinical study of women with hydrosalpinx who were recruited for off-label unilateral or bilateral placement of Essure before IVF (Canadian Task Force classification II-2). Tertiary office-based infertility and IVF practice settings. Twenty women with bilateral or unilateral hydrosalpinx desiring IVF. Office-based Essure placement and subsequent hysterosalpingography confirmation of proximal tubal occlusion. Placement success, and proximal tubal occlusion and birth rate after IVF. Eight women with unilateral hydrosalpinx received unilateral Essure placement, and 12 women with bilateral hydrosalpinx received bilateral placement. One unsuccessful placement occurred. Hysterosalpingography confirmed proximal tubal occlusion in 19 of 20 women (95%) and of 31 of 32 tubes (97%) with Essure placement. Subsequent IVF resulted in 12 live births, for a birth rate per transfer of 57% (12 of 21) and a birth rate per patient of 67% (12 of 20). Four obstetric complications were reported including placenta previa, hypertension, maternal diabetes with premature rupture of membranes, and preeclampsia. All infants are well. Placement of Essure microinserts is an effective method of nonincisional proximal tubal occlusion of hydrosalpinx. Success rates achieved through subsequent IVF are typical of outcomes of good-prognosis in similarly aged patients without hydrosalpinx in our same programs, based on 2008 Society for Assisted Reproductive Technologies data. Copyright © 2011 AAGL. Published by Elsevier Inc. All rights reserved.

  13. Effects of rasagiline on freezing of gait in Parkinson's disease - an open-label, multicenter study.

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    Cibulcik, Frantisek; Benetin, Jan; Kurca, Egon; Grofik, Milan; Dvorak, Miloslav; Richter, Denis; Donath, Vladimir; Kothaj, Jan; Minar, Michal; Valkovic, Peter

    2016-12-01

    Freezing of gait is a disabling symptom in advanced Parkinson's disease. Positive effects have been suggested with MAO-B inhibitors. We report on an open label clinical study on the efficacy of rasagiline as add-on therapy on freezing of gait and quality of life in patients with Parkinson's disease. Forty two patients with freezing of gait were treated with 1 mg rasagiline daily as an add-on therapy. Patients were assessed at baseline and after 1, 2 and 3 months of treatment. Freezing of gait severity was assessed using the Freezing of Gait Questionnaire, motor impairment by the modified MDS UPDRS part III, and quality of life using the PDQ-39 questionnaire. Patients treated with rasagiline had a statistically significant decrease in FoG-Q score and modified MDS UPDRS score after 1, 2 and 3 months of therapy. A moderately strong (r = 0.686, P = 0.002) correlation between the effects on mobility and freezing of gait was found. We also observed a statistically significant improvement in global QoL and in the subscales mobility, ADL, stigma and bodily discomfort in patients after 3 months of rasagiline therapy. A significant correlation (r = 0.570, P = 0.02) between baseline FoG-Q score and the baseline score for the PDQ Mobility subscale was found. In our study rasagiline as add-on antiparkinsonian therapy significantly improved mobility, freezing of gait and quality of life. The positive effect on freezing of gait appears to be related to improvement of mobility.

  14. Multicenter, open-label, exploratory clinical trial with Rhodiola rosea extract in patients suffering from burnout symptoms

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    Kasper S

    2017-03-01

    Full Text Available Siegfried Kasper,1 Angelika Dienel2 1Universitätsklinik für Psychiatrie und Psychotherapie, Medizinische Universität Wien, Wien, Austria; 2Dr Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany Purpose: This study is the first clinical trial aiming to explore the clinical outcomes in burnout patients treated with Rhodiola rosea. The reported capacity of R. rosea to strengthen the organism against stress and its good tolerability offer a promising approach in the treatment of stress-related burnout. The aim of the treatment was to increase stress resistance, thus addressing the source rather than the symptoms of the syndrome and preventing subsequent diseases associated with a history of burnout. The objective of the trial was to provide the exploratory data required for planning future randomized trials in burnout patients in order to investigate the clinical outcomes of treatment with R. rosea dry extract in this target group.Methods: The study was planned as an exploratory, open-label, multicenter, single-arm trial. A wide range of rating scales were assessed and evaluated in an exploratory data analysis to generate hypotheses regarding clinical courses and to provide a basis for the planning of subsequent studies. A total of 118 outpatients were enrolled. A daily dose of 400 mg R. rosea extract (WS® 1375, Rosalin was administered over 12 weeks. Clinical outcomes were assessed by the German version of the Maslach Burnout Inventory, Burnout Screening Scales I and II, Sheehan Disability Scale, Perceived Stress Questionnaire, Number Connection Test, Multidimensional Mood State Questionnaire, Numerical Analogue Scales for different stress symptoms and impairment of sexual life, Patient Sexual Function Questionnaire, and the Clinical Global Impression Scales. Results: The majority of the outcome measures showed clear improvement over time. Several parameters had already improved after 1 week of treatment and continued to improve further up to

  15. Efficacy and safety of long-acting pasireotide in Japanese patients with acromegaly or pituitary gigantism: results from a multicenter, open-label, randomized, phase 2 study.

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    Tahara, Shigeyuki; Murakami, Mami; Kaneko, Tomomi; Shimatsu, Akira

    2017-07-28

    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism. Medically naïve or inadequately controlled patients (on somatostatin analogues or dopamine agonists) were included. Primary end point was the proportion of all patients who achieved biochemical control (mean growth hormone [GH] levelsacromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg. The median age was 52 years (range, 31-79) and 20 patients were males. At month 3, 18.2% of patients (6/33; 90% confidence interval: 8.2%, 32.8%) had biochemical control (21.2% [7/33] when including a patient with mean GHacromegaly or pituitary gigantism.

  16. Pegylated liposomal doxorubicin (Lipo-Dox®) combined with cyclophosphamide and 5-fluorouracil is effective and safe as salvage chemotherapy in taxane-treated metastatic breast cancer: an open-label, multi-center, non-comparative phase II study

    International Nuclear Information System (INIS)

    Rau, Kun-Ming; Lin, Yung-Chang; Chen, Yen-Yang; Chen, Jen-Shi; Lee, Kuan-Der; Wang, Cheng-Hsu; Chang, Hsien-Kun

    2015-01-01

    Anthracycline and taxane are classes of drugs that are frequently used in the adjuvant and palliative settings of metastatic breast cancer (MBC); however, treatment failure occurs in most cases. Limited data demonstrated favorable response in MBC after previous taxane-based treatment. The aim of this study was to evaluate the efficacy and safety of pegylated liposomal doxorubicin (Lipo-Dox®) used as part of a combination salvage therapy for patients with MBC whose tumors progressed during or after taxane-based treatment. Patients with MBC who failed to respond to previous taxane-based treatments were recruited. Treatment with pegylated liposomal doxorubicin (40 mg/m 2 ), cyclophosphamide (500 mg/m 2 ), and 5-fluorouracil (500 mg/m 2 ) was administered every 3 weeks. Tumor response to treatment was determined by using the Response Evaluation Criteria in Solid Tumor criteria version 1.0, and left ventricular ejection fraction was measured before and after treatment using echocardiography. Each patient was followed for 30 days after the last dose of study medication or until resolution/stabilization of any drug-related adverse event. Forty-five patients were recruited. As of December 2012, the median follow-up duration was 29.8 months, the overall response rate was 41.9 %, the median progression-free survival was 8.2 months, and the median overall survival was 36.6 months for all treated patients. Grade 3/4 neutropenia, leucopenia, and neutropenic fever were observed in 14 %, 9 %, and 1 % of the cycles, respectively. Other non-hematologic adverse effects were mild to moderate and were manageable. No decrease in left ventricular ejection function was noted. This regimen of combined of pegylated liposomal doxorubicin, cyclophosphamide, and 5-fluorouracil exhibited a promising overall response rate, progression-free survival rate, and overall survival rate, with a safe cardiac toxicity profile and manageable adverse effects. This regimen could be considered as a treatment option for patients with MBC whose tumors progressed during or after taxane-based treatment

  17. Aripiprazole for Irritability in Asian Children and Adolescents with Autistic Disorder: A 12-Week, Multinational, Multicenter, Prospective Open-Label Study.

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    Kim, Hyo-Won; Park, Eun-Jin; Kim, Ji-Hoon; Boon-Yasidhi, Vitharon; Tarugsa, Jariya; Reyes, Alexis; Manalo, Stella; Joung, Yoo-Sook

    2018-04-24

    We investigated the effectiveness and tolerability of aripiprazole in the treatment of irritability in Asian children and adolescents (6-17 years) with autistic disorder in a 12-week, multinational, multicenter, open-label study. Sixty-seven subjects (10.0 ± 3.1 years old, 52 boys) were enrolled and treated with flexibly dosed aripiprazole for 12 weeks (mean dose, 5.1 ± 2.5 mg; range 2-15 mg). Aripiprazole significantly reduced the mean caregiver-rated scores for the Irritability, Lethargy/Social Withdrawal, Stereotypy, Hyperactivity, and Inappropriate Speech subscales of the Aberrant Behavior Checklist from baseline to week 12 (p autistic disorder. Further studies with larger sample sizes and longer treatment durations are required.

  18. Off-label use analysis of novel antiepileptic drugs in Sichuan area: a multicenter survey in pediatric patients

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    CAI Qian-yun

    2012-10-01

    Full Text Available Objective To investigate current status and safety about off-label use of levetiracetam, topiramate, oxcarbazepine, lamotrigine among pediatric patients in Sichuan area, so as to provide baseline data for formulating guidelines of off-label drug use. Methods Medical records of pediatric epileptic patients receiving antiepileptic drugs (AEDs from July 2010 to November 2011 were collected at the following hospitals: West China Second University Hospital of Sichuan University, Chengdu Women's and Children's Central Hospital and Sichuan Provincial People's Hospital. The numbers of patients receiving AEDs and novel AEDs were calculated. Off-label drug use and the category of off-label drug use were judged according to the indications listed in drug instructions. The incidence of off-label drug use was calculated. The patients receiving novel AEDs were devided into on-label and off-label use groups; the clinical characteristics of these two groups were summarized and adverse reactions of two groups were compared by using χ2 test. Results During the study period, there were totally 854 patients receiving AEDs including 670 patients receiving novel AEDs. Among 670 patients 406 patients off-label use group received off-label use of novel AEDs, accounting for 47.54% (406/854 of the total patients receiving AEDs and 60.60% (406/670 of patients receiving novel AEDs. When compared with on-label use group, off-label use group had more younger patients, more patients with single-drug use and more patients with generalized epilepsy or epileptic syndrome. The rates of off-label using drug were levetiracetam 78.50% (157/200, topiramate 79.81% (253/317, oxcarbazepine 21.32% (42/197 and lamotrigine 33.33% (21/63. The off-label use of levetiracetam and topiramate occured in all three aspects: age, single-drug use and seizure type. The adverse reaction rates of off-label use were oxcarbazepine 16.67% (7/42, topiramate 14.81% (36/243, levetiracetam 10.60% (16

  19. An Open-Label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess VOLUME in the Treatment of Nasolabial Folds

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    Daisy Kopera

    2015-01-01

    Full Text Available The dermal filler Princess VOLUME is a highly cross-linked, viscoelastic hyaluronic acid injectable gel implant used for aesthetic treatment. To evaluate the efficacy and safety of Princess VOLUME in the treatment of nasolabial folds, an open-label uncontrolled, multicenter study was conducted. Forty-eight subjects were recruited who had moderate to deep wrinkles, according to the Modified Fitzpatrick Wrinkle Scale (MFWS. Subjects received Princess VOLUME in both nasolabial folds at Day 0. Nasolabial fold severity was evaluated at 30, 90, 180, and 270 days after treatment, using the MFWS and the Global Aesthetic Improvement Scale (GAIS. Adverse events and treatment site reactions were recorded. Among the 48 subjects, 93.8% were female with a median age of 52 years. There were significant improvements (P<0.0001 in the MFWS scores at 30, 180, and 270 days after treatment compared with those at baseline, with a mean decrease of 1.484 (±0.408, 1.309 (±0.373, and 1.223 (±0.401, respectively; hence the primary endpoint was achieved and clinical efficacy demonstrated. Princess VOLUME was well tolerated, and most adverse events were injection site reactions of mild to moderate severity. Subject satisfaction (97.9%, subject recommendation of the treatment (93.6%, and investigators GAIS scores (97.9% improvement were high.

  20. [Use of itopride in the symptoms of functional dyspepsia in Russia: results of a phase IV prospective open-label multicenter clinical trial].

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    Kas'ianenko, V I; Denisov, N L; Vasil'ev, Iu V

    2014-01-01

    To evaluate the efficacy and safety of itopride used to treat the symptoms of functional dyspepsia (FD) of the upper gastrointestinal tract. A prospective, open-label, multicenter trial using as a control the placebo response obtained in the previous investigations enrolled 96 adult patients. The diagnosis of FD corresponded to its Rome II criteria. Patients received itopride (Ganaton) oral tablets (50 mg) 3 times daily for 8 weeks. When included into the trial, the patients were orally given itopride (ganaton) tablets (50 mg) thrice daily before meals for 8 weeks. The patients' status was evaluated during (at weeks 4 and 8) and after (at week 12) treatment. Treatment response was assessed using the Global Patient Assessment (GPA) and the Leeds Dyspepsia Questionnaire (LDQ). To evaluate the safety of itopride use, the investigators studied the frequency of adverse events and carried out laboratory tests (renal and liver function tests) and electrocardiography (ECG). The GPA showed that 53.76, 85.71, and 82.22% of the patients achieved a therapeutic effect of itopride at weeks 4, 8, and 12, respectively. The proportion of the patients who achieved the therapeutic effect (86%) at week 8 was higher than the historical placebo controls in the previous studies--45% (86% vs 45%; X2 = 68.868, df = 3; p Itopride is an effective and well-tolerated drug in the treatment of functional dyspepsia in the Russian patients.

  1. The MANDELA study: A multicenter, randomized, open-label, parallel group trial to refine the use of everolimus after heart transplantation.

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    Deuse, Tobias; Bara, Christoph; Barten, Markus J; Hirt, Stephan W; Doesch, Andreas O; Knosalla, Christoph; Grinninger, Carola; Stypmann, Jörg; Garbade, Jens; Wimmer, Peter; May, Christoph; Porstner, Martina; Schulz, Uwe

    2015-11-01

    In recent years a series of trials has sought to define the optimal protocol for everolimus-based immunosuppression in heart transplantation, with the goal of minimizing exposure to calcineurin inhibitors (CNIs) and harnessing the non-immunosuppressive benefits of everolimus. Randomized studies have demonstrated that immunosuppressive potency can be maintained in heart transplant patients receiving everolimus despite marked CNI reduction, although very early CNI withdrawal may be inadvisable. A potential renal advantage has been shown for everolimus, but the optimal time for conversion and the adequate reduction in CNI exposure remain to be defined. Other reasons for use of everolimus include a substantial reduction in the risk of cytomegalovirus infection, and evidence for inhibition of cardiac allograft vasculopathy, a major cause of graft loss. The ongoing MANDELA study is a 12-month multicenter, randomized, open-label, parallel-group study in which efficacy, renal function and safety are compared in approximately 200 heart transplant patients. Patients receive CNI therapy, steroids and everolimus or mycophenolic acid during months 3 to 6 post-transplant, and are then randomized at month 6 post-transplant (i) to convert to CNI-free immunosuppression with everolimus and mycophenolic acid or (ii) to continue reduced-exposure CNI, with concomitant everolimus. Patients are then followed to month 18 post-transplant The rationale and expectations for the trial and its methodology are described herein. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia

    Directory of Open Access Journals (Sweden)

    Pandina Gahan

    2012-06-01

    Full Text Available Abstract Background Data on the long-term efficacy, safety, and tolerability of risperidone in adolescents with schizophrenia are limited. The objective of this study was to evaluate the efficacy and safety of maintenance risperidone treatment in adolescents with schizophrenia. Methods This open-label study of adolescents aged 13 to 17 years with schizophrenia was a single extension study of two short-term double-blind risperidone studies and also enrolled subjects directly in open-label risperidone treatment. The risperidone dose was flexible and ranged from 2 to 6 mg/day. Most subjects enrolled for 6 months; a subset enrolled for 12 months. Assessment tools included the Positive and Negative Syndrome Scale total and factor scores, Clinical Global Impressions, Children’s Global Assessment Scale, adverse event (AE monitoring, vital signs, laboratory testing, and extrapyramidal symptom rating scales. Results A total of 390 subjects were enrolled; 48 subjects had received placebo in a previous double-blind study; 292 subjects had received risperidone as part of their participation in one of two previous controlled studies; and 50 subjects were enrolled directly for this study. A total of 279 subjects enrolled for 6 months of treatment, and 111 subjects enrolled for 12 months of treatment. Overall, 264 (67.7% subjects completed this study: 209 of the 279 subjects (75% in the 6-month group and 55 of the 111 subjects (50% in the 12-month group. The median mode dose was 3.8 mg/day. At 6 months, all three groups experienced improvement from open-label baseline in symptoms of schizophrenia as well as general assessments of global functioning. Improvements were generally maintained for the duration of treatment. The most common AEs (≥10% of subjects were somnolence, headache, weight increase, hypertonia, insomnia, tremor, and psychosis. Potentially prolactin-related AEs (PPAEs were reported by 36 (9% subjects. The AE profile in this study was

  3. Clinical effectiveness and safety of OROS® hydromorphone in break-through cancer pain treatment: a multicenter, prospective, open-label study in Korean patients.

    Science.gov (United States)

    Lee, Kyung Hee; Kim, Min Kyoung; Hyun, Myung Soo; Kim, Jin Young; Park, Keon Uk; Song, Hong Suk; Lee, Sun Ah; Lee, Won Sik; Bae, Sung Hwa; Ryoo, Hun Mo; Cho, Yoon Young

    2012-01-01

    To evaluate the effectiveness of OROS® hydromorphone in reducing breakthrough pain (BTP) medication frequency in Korean patients with chronic cancer pain. Multicenter, prospective, open-label, phase IV study. Patients with chronic malignant pain using immediate-release oxycodone more than two times per day for BTP. Patients were stabilized on their ongoing drug for 3 days immediately before baseline measurements (day 0). Medication was changed to OROS® hydromorphone at a dose equianalgesic to oxycodone using a 2.5:1 controlled-release oxycodone to hydromorphone hydrochloride conversion ratio; the patients were observed for 7 days. Dose was titrated, if required, and the patients were observed for another 7 days. Effectiveness and safety parameters were measured at baseline, day 7, and day 14. BTP medication frequency on days 7 and 14, compared to baseline. Of the 141 patients screened, 114 received study drug and 98 completed the study. Compared to day 0, daily BTP medication frequency on day 14 decreased from 2.93 to 2.00 (p > 0.0001), daily BTP frequency decreased from 3.67 to 2.44 (p > 0.0001), and end-of-dose pain frequency decreased by 44 percent. Pain was controlled adequately during daytime and night-time. Pain intensity decreased by 11 percent as assessed using the Korean Brief Pain Inventory and by 17 percent as assessed using the numerical rating scale. About 61.2 percent patients and 60.2 percent physicians were satisfied with the treatment. Common adverse events, which occurred in 91.2 percent patients, were constipation, somnolence, and dizziness. Once-daily OROS® hydromorphone is efficient in the reduction of cancer pain-related BTP episodes, including end-of-dose pain.

  4. Pilot, Multicenter, Open-Label Evaluation of Safety, Tolerability and Efficacy of a Novel, Topical Multipotent Growth Factor Formulation for the Periorbital Region.

    Science.gov (United States)

    Sundaram, Hema; Gold, Michael; Waldorf, Heidi; Lupo, Mary; Nguyen, Vivien L; Karnik, Jwala

    2015-12-01

    This multicenter, open-label pilot study evaluated safety, efficacy and tolerability of a topical formulation containing a multipotent growth factor resignaling complex (MRCx), when applied to infraorbital and lateral canthal skin. Thirty-nine female subjects with mean age of 56.8 years who had periorbital lines and wrinkles, uneven skin texture, puffiness, and lack of skin firmness were enrolled, and 38 completed the study. All subjects applied the multipotent growth factor formulation bilaterally to the periorbital area, twice daily for 60 days. Efficacy and treatment-related adverse events were evaluated at Baseline and days 14, 30, and 60. Investigators rated the periorbital areas based on 10-point scales. Subjects' self-reported compliance with treatment was greater than 99% throughout the study. At day 60, all subjects had improvement in infraorbital brightness (≥ 2 points), moistness (≥ 2 points), wrinkles (≥ 1 point), sallowness (≥ 1 point), crepiness (≥ 1 point), smooth texture (≥ 1 point), skin tightness (≥ 1 point), and skin tone (≥ 1 point). Investigator-rated assessments showed ≥ 1-point improvement for lateral canthal wrinkles, dyschromia/mottled pigmentation, skin tone, overall brightness, and moistness. Investigator-rated scoring on the Global Aesthetic Improvement Scale (GAIS) demonstrated that 67.6% of subjects were much improved/improved at day 14, and 63.1% remained improved at day 60. Overall, 76.2% and 79.0% of subjects were very pleased/pleased/mostly pleased with the appearance of their infraorbital and lateral canthal areas at day 60. Adverse events comprised one case of mild canthal erythema, and one case of mild eye irritation, both of which were respectively resolved. This pilot study demonstrated that the topical multipotent growth factor formulation was safe, effective and well tolerated for periorbital skin rejuvenation.

  5. VANTAGE 095: An International, Multicenter, Open-Label Study of Vorinostat (MK-0683) in Combination With Bortezomib in Patients With Relapsed and Refractory Multiple Myeloma.

    Science.gov (United States)

    Siegel, David S; Dimopoulos, Meletios; Jagannath, Sundar; Goldschmidt, Hartmut; Durrant, Simon; Kaufman, Jonathan L; Leleu, Xavier; Nagler, Arnon; Offner, Fritz; Graef, Thorsten; Eid, Joseph E; Houp, Jennifer; Gause, Christine; Vuocolo, Scott; Anderson, Kenneth C

    2016-06-01

    The present global, open-label, single-arm, multicenter, phase IIb study was designed to determine the efficacy and tolerability of oral vorinostat combined with standard doses of bortezomib in patients with multiple myeloma considered refractory to novel myeloma agents. Eligible patients were age ≥ 18 years, had received ≥ 2 previous regimens, had disease refractory to ≥ 1 previous bortezomib-containing regimen, and had received ≥ 1 dose of an immunomodulatory drug (thalidomide or lenalidomide)-based regimen. The patients received 21-day cycles of bortezomib (1.3 mg/m(2) intravenously on days 1, 4, 8, and 11) plus oral vorinostat (400 mg/d on days 1-14). Oral dexamethasone, 20 mg, on the day of and the day after each dose of bortezomib could be added for patients with progressive disease after 2 cycles or no change after 4 cycles. The primary endpoint was the objective response rate. The objective response rate was 11.3% (95% confidence interval, 6.6%-17.7%), and the median duration of response was 211 days (range, 64-550 days). The median overall survival duration was 11.2 months (95% confidence interval, 8.5-14.4 months), with a 2-year survival rate of 32%. The frequently reported adverse events were thrombocytopenia (69.7%), nausea (57.0%), diarrhea (53.5%), anemia (52.1%), and fatigue (48.6%); the overall safety profile was consistent with that of bortezomib and vorinostat. The combination of vorinostat and bortezomib is active in patients with multiple myeloma refractory to novel treatment modalities and offers a new therapeutic option for this difficult-to-treat patient population (ClinicalTrials.gov identifier, NCT00773838). Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Sirolimus Use in Liver Transplant Recipients With Hepatocellular Carcinoma: A Randomized, Multicenter, Open-Label Phase 3 Trial

    Science.gov (United States)

    Geissler, Edward K.; Schnitzbauer, Andreas A.; Zülke, Carl; Lamby, Philipp E.; Proneth, Andrea; Duvoux, Christophe; Burra, Patrizia; Jauch, Karl-Walter; Rentsch, Markus; Ganten, Tom M.; Schmidt, Jan; Settmacher, Utz; Heise, Michael; Rossi, Giorgio; Cillo, Umberto; Kneteman, Norman; Adam, René; van Hoek, Bart; Bachellier, Philippe; Wolf, Philippe; Rostaing, Lionel; Bechstein, Wolf O.; Rizell, Magnus; Powell, James; Hidalgo, Ernest; Gugenheim, Jean; Wolters, Heiner; Brockmann, Jens; Roy, André; Mutzbauer, Ingrid; Schlitt, Angela; Beckebaum, Susanne; Graeb, Christian; Nadalin, Silvio; Valente, Umberto; Turrión, Victor Sánchez; Jamieson, Neville; Scholz, Tim; Colledan, Michele; Fändrich, Fred; Becker, Thomas; Söderdahl, Gunnar; Chazouillères, Olivier; Mäkisalo, Heikki; Pageaux, Georges-Philippe; Steininger, Rudolf; Soliman, Thomas; de Jong, Koert P.; Pirenne, Jacques; Margreiter, Raimund; Pratschke, Johann; Pinna, Antonio D.; Hauss, Johann; Schreiber, Stefan; Strasser, Simone; Klempnauer, Jürgen; Troisi, Roberto I.; Bhoori, Sherrie; Lerut, Jan; Bilbao, Itxarone; Klein, Christian G.; Königsrainer, Alfred; Mirza, Darius F.; Otto, Gerd; Mazzaferro, Vincenzo; Neuhaus, Peter; Schlitt, Hans J.

    2016-01-01

    Background We investigated whether sirolimus-based immunosuppression improves outcomes in liver transplantation (LTx) candidates with hepatocellular carcinoma (HCC). Methods In a prospective-randomized open-label international trial, 525 LTx recipients with HCC initially receiving mammalian target of rapamycin inhibitor–free immunosuppression were randomized 4 to 6 weeks after transplantation into a group on mammalian target of rapamycin inhibitor–free immunosuppression (group A: 264 patients) or a group incorporating sirolimus (group B: 261). The primary endpoint was recurrence-free survival (RFS); intention-to-treat (ITT) analysis was conducted after 8 years. Overall survival (OS) was a secondary endpoint. Results Recurrence-free survival was 64.5% in group A and 70.2% in group B at study end, this difference was not significant (P = 0.28; hazard ratio [HR], 0.84; 95% confidence interval [95% CI], 0.62; 1.15). In a planned analysis of RFS rates at yearly intervals, group B showed better outcomes 3 years after transplantation (HR, 0.7; 95% CI, 0.48-1.00). Similarly, OS (P = 0.21; HR, 0.81; 95% CI, 0.58-1.13) was not statistically better in group B at study end, but yearly analyses showed improvement out to 5 years (HR, 0.7; 95% CI, 0.49-1.00). Interestingly, subgroup (Milan Criteria-based) analyses revealed that low-risk, rather than high-risk, patients benefited most from sirolimus; furthermore, younger recipients (age ≤60) also benefited, as well sirolimus monotherapy patients. Serious adverse event numbers were alike in groups A (860) and B (874). Conclusions Sirolimus in LTx recipients with HCC does not improve long-term RFS beyond 5 years. However, a RFS and OS benefit is evident in the first 3 to 5 years, especially in low-risk patients. This trial provides the first high-level evidence base for selecting immunosuppression in LTx recipients with HCC. PMID:26555945

  7. Two-year follow-up of an open-label multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and stress-predominant mixed incontinence

    DEFF Research Database (Denmark)

    Toozs-Hobson, Philip; Al-Singary, Waleed; Fynes, Michelle

    2012-01-01

    Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This article presents the 2-year follow-up results of a multicenter study of PAHG injections for treating stress and stress-predominant mixed urinary incontinence....

  8. Efficacy and safety of a flexible extended regimen of ethinylestradiol/drospirenone for the treatment of dysmenorrhea: a multicenter, randomized, open-label, active-controlled study

    Directory of Open Access Journals (Sweden)

    Momoeda M

    2017-05-01

    Full Text Available Mikio Momoeda,1 Masami Kondo,2 Joerg Elliesen,3 Masanobu Yasuda,2 Shigetomo Yamamoto,4 Tasuku Harada5 1Department of Integrated Women’s Health, St Luke’s International Hospital, Tokyo, 2Product Development, Bayer Yakuhin Ltd, Osaka, Japan; 3Global Clinical Development, Bayer AG, Berlin, Germany; 4Medical Affairs, Bayer Yakuhin Ltd, Osaka, 5Department of Obstetrics and Gynecology, Tottori University Faculty of Medicine, Tottori, Japan Background: Dysmenorrhea is a common condition in women, which is characterized by menstrual pain. Low-dose estrogen/progestin combined oral contraceptives have been shown to reduce the severity of dysmenorrhea symptoms, and a 28-day cyclic regimen of ethinylestradiol/drospirenone (28d regimen is approved for this indication in Japan. Aim: The aim of this study was to assess the safety and efficacy of a flexible extended regimen of ethinylestradiol/drospirenone (flexible regimen in Japanese women with dysmenorrhea. Methods: This multicenter, open-label study was performed in Japanese women with dysmenorrhea who, after a baseline observational phase, were randomized to receive ethinylestradiol 20 µg/drospirenone 3 mg in a flexible regimen (one tablet each day for 24–120 days followed by a 4-day tablet-free interval or in the standard 28d regimen (one tablet each day for 24 days, followed by 4 days of placebo tablets for six cycles. The primary endpoint was the number of days with dysmenorrhea of at least mild intensity over a 140-day evaluation period. Dysmenorrhea scores, bleeding patterns, and other pain-related parameters were also assessed. Results: A total of 216 women (mean age 29.7 years were randomized to the flexible regimen (n=108 or 28d regimen (n=108 and 212 were included in the full analysis sets (flexible regimen, n=105; 28d regimen, n=107. Women in the flexible-regimen group reported a mean of 3.4 fewer days with dysmenorrheic pain than women in the 28d-regimen group, with similar decreases in

  9. Nimotuzumab plus chemotherapy versus chemotherapy alone in advanced non-small-cell lung cancer: a multicenter, randomized, open-label Phase II study

    Directory of Open Access Journals (Sweden)

    Babu KG

    2014-06-01

    Full Text Available K Govind Babu,1 Kumar Prabhash,2 Ashok K Vaid,3 Bhawna Sirohi,3 Ravi B Diwakar,4 Raghunadha Rao,5 Madhuchanda Kar,6 Hemant Malhotra,7 Shona Nag,8 Chanchal Goswami,9 Vinod Raina,10 Ravi Mohan111Kidwai Memorial Institute of Oncology, Bangalore, 2Tata Memorial Hospital, Mumbai, 3Artemis Health Institute, Delhi, 4Bangalore Institute of Oncology, Bangalore, 5Nizam Institute of Medical Sciences, Hyderabad, 6B R Singh Hospital, Kolkata, 7Birla Cancer Centre, Jaipur, 8Jehangir Hospital, Pune, 9B P Poddar Hospital and Medical Research Ltd, Kolkata, 10Institute Rotary Cancer Hospital, New Delhi, 11King George Hospital, Visakhapatnam, IndiaBackground: The purpose of this study was to evaluate the safety and efficacy of nimotuzumab in combination with chemotherapy (docetaxel and carboplatin versus chemotherapy alone in patients with stage IIIB/IV non-small-cell lung cancer.Methods: This multicenter, open-label, Phase II study randomized 110 patients to receive nimotuzumab plus chemotherapy (nimotuzumab group or chemotherapy alone (control group, and comprised concomitant, maintenance, and follow-up phases. Nimotuzumab 200 mg was administered once weekly for 13 weeks during the first two phases with four cycles of chemotherapy and docetaxel 75 mg/m2 and carboplatin (area under the curve 5 mg/mL*min every 3 weeks for a maximum of four cycles during the concomitant phase. The primary endpoint was objective response rate (sum of complete response and partial response. Secondary endpoints, ie, overall survival and progression-free survival, were estimated using the Kaplan–Meier method. Efficacy was evaluated on the intent-to-treat and efficacy-evaluable sets. Safety was assessed from adverse event and serious adverse event data.Results: The objective response rate was significantly higher in the nimotuzumab group than in the control group in the intent-to-treat population (54% versus 34.5%; P=0.04. A complete response and partial response were achieved in 3

  10. A 64-week, multicenter, open-label study of aripiprazole effectiveness in the management of patients with schizophrenia or schizoaffective disorder in a general psychiatric outpatient setting

    Directory of Open Access Journals (Sweden)

    Chiu Nan-Ying

    2010-09-01

    Full Text Available Abstract Objective To evaluate the overall long-term effectiveness of aripiprazole in patients with schizophrenia in a general psychiatric practice setting in Taiwan. Methods This was a prospective, open-label, multicenter, post-market surveillance study in Taiwanese patients with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV diagnosis of schizophrenia or schizoaffective disorder requiring a switch in antipsychotic medication because current medication was not well tolerated and/or clinical symptoms were not well controlled. Eligible patients were titrated to aripiprazole (5-30 mg/day over a 12-week switching phase, during which their previous medication was discontinued. Patients could then enter a 52-week, long-term treatment phase. Aripiprazole was flexibly dosed (5-30 mg/day at the discretion of the treating physicians. Efficacy was assessed using the Clinical Global Impression scale Improvement (CGI-I score, the Clinical Global Impression scale Severity (CGI-S score, The Brief Psychiatry Rating Scale (BPRS, and the Quality of Life (QOL scale, as well as Preference of Medicine (POM ratings by patients and caregivers. Safety and tolerability were also assessed. Results A total of 245 patients were enrolled and switched from their prior antipsychotic medications, and 153 patients entered the 52-week extension phase. In all, 79 patients (32.2% completed the study. At week 64, the mean CGI-I score was 3.10 and 64.6% of patients who showed response. Compared to baseline, scores of CGI-S, QOL, and BPRS after 64 weeks of treatment also showed significant improvements. At week 12, 65.4% of subjects and 58.9% of caregivers rated aripiprazole as better than the prestudy medication on the POM. The most frequently reported adverse events (AEs were headache, auditory hallucinations and insomnia. A total of 13 patients (5.3% discontinued treatment due to AEs. No statistically significant changes were noted with respect to

  11. The expert meeting dedicated to the discussion of results of a local open-label multicenter observational study of the efficiency and safety of tofacitinib in patients with active rheumatoid arthritis with the inefficiency of disease-modifying antirheumatic drugs and to the elaboration of recommendations for the use for tofacitinib in the therapy of rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    2016-01-01

    Full Text Available The expert meeting dedicated to the discussion of results of a local open-label multicenter observational study of the efficiency and safety of tofacitinib in patients with active rheumatoid arthritis with the inefficiency of disease-modifying antirheumatic drugs and to the elaboration of recommendations for the use for tofacitinib in the therapy of rheumatoid arthritis.

  12. Non-comparative and comparative advertising in oligopolistic markets

    OpenAIRE

    Alipranti, Maria; Mitrokostas, Evangelos; Petrakis, Emmanuel

    2016-01-01

    We study firms' advertising strategies in an oligopolistic market in which both non-comparative and comparative advertising are present. We show that in equilibrium firms mix over the two types of advertising, with the intensity of comparative advertising exceeding that of non-comparative advertising; moreover, that the intensity of comparative increases relatively to non-comparative advertising as market competition intensifies. Interestingly, the use of comparative advertising may lead to h...

  13. The effectiveness and safety of amisulpride in Chinese patients with schizophrenia: An 8‐week, prospective, open‐label, multicenter, single‐arm study

    Science.gov (United States)

    Liang, Ying; Cao, Changan; Zhu, Cheng; Wang, Chuanyue; Zhang, Congpei; Dong, Fang; Yang, Fude; Deng, Hong; Yu, Jingjie; Tang, Jisheng; Su, Lei; Xin, Limin; Hong, Ling; Gao, Minglong; Tang, Muni; Xie, Shiping; Lu, Shuiping; Liu, Tiebang; Xu, Xiaojin; Wang, Xijin; Li, Xuanzi; Wang, Xueyi; Li, Yi; Zhang, Yong; Chen, Zhiyu

    2016-01-01

    Abstract Introduction This study evaluated the effectiveness and safety of amisulpride in Chinese schizophrenia patients. Methods A multicenter, single‐arm Phase IV study (NCT01795183). Chinese patients with schizophrenia received amisulpride for 8 weeks. The primary endpoint was ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Results A total of 316 patients were enrolled; 295 were included in the effectiveness analysis; 66.8% (197/295) achieved ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Nine patients discontinued treatment because of adverse events. Discussion Amisulpride had clinical effectiveness and was relatively well tolerated in Chinese patients with schizophrenia. PMID:27020720

  14. EffenDys-Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Patients With Advanced Cancer: A Multicenter, Open-Label, Randomized, Morphine-Controlled, Crossover, Phase II Trial.

    Science.gov (United States)

    Simon, Steffen T; Kloke, Marianne; Alt-Epping, Bernd; Gärtner, Jan; Hellmich, Martin; Hein, Rebecca; Piel, Maren; Cornely, Oliver A; Nauck, Friedemann; Voltz, Raymond

    2016-11-01

    Episodic breathlessness is a frequent and burdensome symptom in cancer patients but pharmacological treatment is limited. To determine time to onset, efficacy, feasibility, and safety of transmucosal fentanyl in comparison to immediate-release morphine for the relief of episodic breathlessness. Phase II, investigator-initiated, multicenter, open-label, randomized, morphine-controlled, crossover trial with open-label titration of fentanyl buccal tablet (FBT) in inpatients with incurable cancer. The primary outcome was time to onset of meaningful breathlessness relief. Secondary outcomes were efficacy (breathlessness intensity difference at 10 and 30 minutes; sum of breathlessness intensity difference at 15 and 60 minutes), feasibility, and safety. Study was approved by local ethics committees. Twenty-five of 1341 patients were eligible, 10 patients agreed to participate (four female, mean age 58 ± 11, mean Karnofsky score 67 ± 11). Two patients died before final visits and two patients dropped-out because of disease progression leaving six patients for analysis with 61 episodes of breathlessness. Mean time to onset was for FBT 12.7 ± 10.0 and for immediate-release morphine 23.6 ± 15.1 minutes with a mean difference of -10.9 minutes (95% CI = -24.5 to 2.7, P = 0.094). Efficacy measures were predominately in favor for FBT. Both interventions were safe. Feasibility failed because of too much study demands for a very ill patient group. The description of a faster and greater relief of episodic breathlessness by transmucosal fentanyl versus morphine justifies further evaluation by a full-powered trial. Copyright © 2016. Published by Elsevier Inc.

  15. A Phase 3, multicenter, open-label, switchover trial to assess the safety and efficacy of taliglucerase alfa, a plant cell-expressed recombinant human glucocerebrosidase, in adult and pediatric patients with Gaucher disease previously treated with imiglucerase.

    Science.gov (United States)

    Pastores, Gregory M; Petakov, Milan; Giraldo, Pilar; Rosenbaum, Hanna; Szer, Jeffrey; Deegan, Patrick B; Amato, Dominick J; Mengel, Eugen; Tan, Ee Shien; Chertkoff, Raul; Brill-Almon, Einat; Zimran, Ari

    2014-12-01

    Taliglucerase alfa is a β-glucosidase enzyme replacement therapy (ERT) approved in the US and other countries for the treatment of Gaucher disease (GD) in adults and is approved in pediatric and adult patients in Australia and Canada. It is the first approved plant cell-expressed recombinant human protein. A Phase 3, multicenter, open-label, 9-month study assessed safety and efficacy of switching to taliglucerase alfa in adult and pediatric patients with GD treated with imiglucerase for at least the previous 2years. Patients with stable disease were offered taliglucerase alfa treatment using the same dose (9-60U/kg body weight) and regimen of administration (every 2weeks) as imiglucerase. This report summarizes results from 26 adult and 5 pediatric patients who participated in the trial. Disease parameters (spleen and liver volumes, hemoglobin concentration, platelet count, and biomarker levels) remained stable through 9months of treatment in adults and children following the switch from imiglucerase. All treatment-related adverse events were mild or moderate in severity and transient in nature. Exploratory parameters of linear growth and development showed positive outcomes in pediatric patients. These findings provide evidence of the efficacy and safety profile of taliglucerase alfa as an ERT for GD in patients previously treated with imiglucerase. This trial was registered at www.clinicaltrials.gov as # NCT00712348. Copyright © 2014 Elsevier Inc. All rights reserved.

  16. A multicenter, open-label trial to evaluate the quality of life in adults with ADHD treated with long-acting methylphenidate (OROS MPH): Concerta Quality of Life (CONQoL) study.

    Science.gov (United States)

    Mattos, Paulo; Louzã, Mário Rodrigues; Palmini, André Luís Fernandes; de Oliveira, Irismar Reis; Rocha, Fábio Lopes

    2013-07-01

    The available literature provides few studies on the effectiveness of methylphenidate in improving quality of life in individuals with ADHD. To assess the effectiveness of methylphenidate OROS formulation (OROS MPH) through QoL in adults with ADHD. A 12-week, multicenter, open-label trial involving 60 patients was used. The measures used were Adult Self-Rating Scale, Adult ADHD Quality of Life Scale (AAQoL), State and Trait Anxiety Inventory (STAI), Hamilton Depression Rating Scale (HAM-D), Clinical Global Impression (CGI), and safety measures. A significance statistic level of 5% was adopted. Analyses included 60 patients (66.7% male; M age = 31.1 years) for safety and 58 patients for effectiveness. All AAQoL subscales improved from baseline to Week 12 (p < .0001), as well as the Total AAQoL (p < .0001). A significant reduction on Clinical Global Impression-Improvement (CGI-I), HAM-D, STAI, and ASRS scores was observed (p < .0001). No serious adverse event was reported. Treatment of adult ADHD patients with OROS MPH improves QoL.

  17. Substitution of ethambutol with linezolid during the intensive phase of treatment of pulmonary tuberculosis: study protocol for a prospective, multicenter, randomized, open-label, phase II trial.

    Science.gov (United States)

    Lee, Ji Yeon; Kim, Deog Kyeom; Lee, Jung-Kyu; Yoon, Ho Il; Jeong, Ina; Heo, Eunyoung; Park, Young Sik; Lee, Jae Ho; Park, Sung Soo; Lee, Sang-Min; Lee, Chang-Hoon; Lee, Jinwoo; Choi, Sun Mi; Park, Jong Sun; Joh, Joon-Sung; Cho, Young-Jae; Lee, Yeon Joo; Kim, Se Joong; Hwang, Young Ran; Kim, Hyeonjeong; Ki, Jongeun; Choi, Hyungsook; Han, Jiyeon; Ahn, Heejung; Hahn, Seokyung; Yim, Jae-Joon

    2017-02-13

    Linezolid, an oxazolidinone, substantially improves treatment outcomes of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis. We started a trial to test whether the use of linezolid instead of ethambutol could increase the rate of sputum culture conversion as of 8 weeks of treatment in patients with drug-susceptible tuberculosis. This is a phase II, multicenter, randomized study with three arms. We are enrolling patients with pulmonary tuberculosis without rifampicin resistance screened by the Xpert MTB/RIF® assay. The standard treatment arm uses isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and ethambutol (2 months). Experimental arm 1 uses linezolid (600 mg/day) for 4 weeks instead of ethambutol. Experimental arm 2 uses linezolid (600 mg/day) for 2 weeks instead of ethambutol. The primary outcome is the sputum culture conversion rate on liquid media after 2 months of treatment. Secondary outcomes include the sputum culture conversion rate on solid media after 2 months of treatment, time to sputum culture conversion on liquid and solid media, cure rate, and treatment success rate. The frequencies of total adverse events (AEs) and serious AEs will be described and documented. Based on an α = 0.05 level of significance, a power of 85%, a 15% difference in the culture conversion rate after 2 months between the control arm and experimental arm 1 (75% vs. 90%), a 10% default (loss to follow-up) rate, and a 10% culture failure, the required number per arm was calculated to be 143 (429 in total). This trial will reveal the effectiveness and safety of 2 or 4 weeks of use of linezolid instead of ethambutol for patients with drug-susceptible pulmonary tuberculosis. If a new regimen including linezolid shows a higher culture conversion rate by week 8, and is safe, it could be tested as a 4-month antituberculosis treatment regimen in the future. ClincalTrials.gov, NCT01994460 . Registered on 13 November 2013.

  18. Effect of consuming a purple-fleshed sweet potato beverage on health-related biomarkers and safety parameters in Caucasian subjects with elevated levels of blood pressure and liver function biomarkers: a 4-week, open-label, non-comparative trial.

    Science.gov (United States)

    Oki, Tomoyuki; Kano, Mitsuyoshi; Watanabe, Osamu; Goto, Kazuhisa; Boelsma, Esther; Ishikawa, Fumiyasu; Suda, Ikuo

    2016-01-01

    An open-label study with one treatment arm was conducted to investigate changes in health-related biomarkers (blood pressure and liver enzyme activity) and the safety of 4 weeks of consuming a purple-fleshed sweet potato beverage in Caucasian subjects. Twenty healthy adults, 18-70 years of age, with a body mass index >25 kg/m(2), elevated blood pressure and elevated levels of liver function biomarkers consumed two cartons of purple-fleshed sweet potato beverage (125 ml, including 117 mg anthocyanin per carton) daily for 4 weeks. Hematology, serum clinical profile, dipstick urinalysis and blood pressure were determined before consumption, at 2 and 4 weeks of consumption and after a 2-week washout period. A trend was found toward lowering systolic blood pressure during the treatment period (p=0.0590). No significant changes were found in diastolic blood pressure throughout the study period. Systolic blood pressure was significantly lower after 4 weeks of consumption compared with before consumption (p=0.0125) and was significantly higher after the 2-week washout period compared with after consumption (p=0.0496). The serum alanine aminotransferase level significantly increased over time, but aspartate aminotransferase and γ-glutamyltransferase levels stayed within the normal range of reference values. Safety parameters of the blood and urine showed no clinically relevant changes. The consumption of a purple-fleshed sweet potato beverage for 4 weeks resulted in no clinically relevant changes in safety parameters of the blood and urine and showed a trend toward lowering systolic blood pressure.

  19. An Open-Label, Multicenter Observational Study for Patients with Alzheimer’s Disease Treated with Memantine in the Clinical Practice

    Directory of Open Access Journals (Sweden)

    S.S. Stamouli

    2011-01-01

    Full Text Available Background/Aims: In this post-marketing observational study, the safety and effectiveness of memantine were evaluated in patients with Alzheimer’s disease (AD. Methods: In a 6-month, observational, open-label study at 202 specialist sites in Greece, the effectiveness of memantine was evaluated using the Mini-Mental State Examination (MMSE and the Instrumental Activities of Daily Living (IADL scale at baseline, and after 3 and 6 months. Discontinuation rates and adverse drug reactions (ADRs were also recorded to evaluate the safety profile of memantine. Results: 2,570 patients participated in the study. Three and 6 months after baseline, MMSE and IADL scores were significantly improved compared to baseline. At the end of the study, 67% of the patients had improved their MMSE score; 7.1% of the patients reported ≧1 ADRs, and treatment was discontinued due to ADR in 0.7%. Conclusion: Memantine was well tolerated and had a positive effect on the patient’s cognitive and functional ability in real-life clinical practice, in agreement with randomized, controlled trials.

  20. Radioimmunoscintigraphy of recurrent, metastatic, or occult colorectal cancer with technetium 99m-labeled totally human monoclonal antibody 88BV59: results of pivotal, phase III multicenter studies.

    Science.gov (United States)

    Serafini, A N; Klein, J L; Wolff, B G; Baum, R; Chetanneau, A; Pecking, A; Fischman, A J; Hoover, H C; Wynant, G E; Subramanian, R; Goroff, D K; Hanna, M G

    1998-05-01

    To assess the performance and potential clinical impact of a totally human monoclonal antibody, 88BV59 (HumaSPECT) (INTRACEL, Corp, Rockville, MD), in 202 assessable presurgical patients with recurrent, metastatic, or occult colorectal cancer. 88BV59, labeled with technetium Tc 99m (99mTc) (HumaSPECT-Tc), was injected intravenously, and planar and single photon emission tomography (SPECT) images were obtained 14 to 20 hours postinjection. Surgical and pathologic verification of tumor were used as the standard against which the performance of HumaSPECT-Tc imaging and computed tomography (CT) analysis were evaluated. All patients entered onto the recurrent disease study had at least one tumor site defined on CT. The sensitivity of HumaSPECT-Tc in those CT-positive patients was 87%. The specificity of HumaSPECT-Tc was 57% compared with 17% for CT and the difference was statistically significant (P HAHA) response (90 ng/mL) at 9 weeks postinfusion was observed. HumaSPECT-Tc can provide important and accurate information about the presence and location of disease in patients with a high clinical suspicion of metastatic or recurrent colorectal cancer and either positive (known disease) or negative (occult disease) CT scans.

  1. Safety and efficacy of paliperidone palmitate 1-month formulation in Chinese patients with schizophrenia: a 25-week, open-label, multicenter, Phase IV study

    Directory of Open Access Journals (Sweden)

    Zhao JP

    2017-08-01

    Full Text Available Jingping Zhao,1,* Lehua Li,1,* Jianguo Shi,2 Yi Li,3 Xiufeng Xu,4 Keqing Li,5 Lili Zhang,6 Shangli Cai,6 Yu Feng,6 Jianmin Zhuo,6 Weihong Liu,6 Huafei Lu6 1Department of Psychiatry, The Mental Health Institute, The Second Xiangya Hospital of Central South University, 2Department of Psychiatry, Mental Health Center of Xi’an City, 3Department of Psychiatry, Mental Health Center of Wuhan City, 4Department of Psychiatry, First Affiliated Hospital of Kunming Medical University, 5Department of Psychiatry, The Sixth People’s Hospital of Hebei Province, 6Department of Medical Affairs, Xi’an Janssen Pharmaceutical Ltd., Beijing, People’s Republic of China *These authors contributed equally to this work Rationale: Long-acting injectable (LAI paliperidone palmitate 1-month formulation (PP1M has demonstrated acceptable tolerability and favorable clinical outcomes in Western and Asian patients with schizophrenia. Hence, analysis of the outcomes of long-term PP1M treatment specifically in Chinese patients is of interest.Objective: The aim of this study is to evaluate the long-term safety and efficacy of PP1M treatment in Chinese patients with schizophrenia.Methods: In this 25-week, open-label, Phase IV study, patients (18–65 years diagnosed with schizophrenia and having a baseline Positive and Negative Syndrome Scale (PANSS total score of 60–120 (inclusive were enrolled. All patients received injections of PP1M 150 mg eq. (day 1 and 100 mg eq. (day 8, followed by a flexible once-monthly maintenance dosing (75, 100, or 150 mg eq..Results: Of the 353 patients, 234 (66.3% completed the study treatment (mean age, 31.1 years; 52.7% men. The PANSS total score (primary end point improved significantly over the 6-month treatment period (mean [standard deviation] change from baseline to end of treatment, -27.2 [18.30]; P<0.0001. The Clinical Global Impressions-Severity and Personal and Social Performance scores (secondary end points also improved

  2. Study design of the influence of SErotonin inhibition on patients with RENAl impairment or diabetes undergoing drug-eluting stent implantation (SERENADE) study: A multicenter, open-label, prospective, randomized study.

    Science.gov (United States)

    Lee, Seung-Ah; Suh, Jung-Won; Park, Jin Joo; Yoon, Chang-Hwan; Cho, Young-Suk; Youn, Tae-Jin; Chae, In-Ho; Kim, Hyo-Soo; Kim, Sang-Hyun; Choi, Dong-Ju

    2015-07-01

    The rates of stent failure after percutaneous coronary intervention have decreased since the introduction of the drug-eluting stent (DES). However, chronic kidney disease (CKD) and diabetes mellitus (DM) remain strong clinical predictors of poor prognosis despite DES implantation. Sarpogrelate, a selective serotonin (5-hydroxytryptamine (HT)2a [5-HT2A]) receptor antagonist, has antiproliferative effects, reducing neointimal hyperplasia and smooth muscle cell proliferation, as well as potent antiplatelet action, inhibiting 5-HT-induced platelet aggregation. However, efficacy and safety data for sarpogrelate in patients with CKD or DM are limited. We aim to determine whether sarpogrelate has beneficial effects in patients with CDK or DM treated with DES implantation. The SERENADE trial is a multicenter, open-label, prospective, randomized study that will test the superiority of triple anti-platelet therapy (TAT; aspirin, clopidogrel, and sarpogrelate) to conventional dual antiplatelet therapy (DAT; aspirin and clopidogrel) in preventing late lumen loss 9 months after the index procedure in patients with CKD or DM. A total of 220 patients diagnosed with coronary artery disease with DM or CKD will be randomized to the TAT or DAT groups (1:1 ratio) after DES implantation. The primary endpoint is late lumen loss at 9 months assessed by quantitative coronary angiography. Secondary efficacy endpoints are composites of major adverse cardiovascular events including cardiac death, nonfatal myocardial infarction, and target lesion revascularization. Secondary safety endpoints are major bleeding events and hepatic or renal impairment. The SERENADE trial will provide insight on the efficacy of adjunctive therapy with sarpogrelate after DES implantation for patients with high-risk profiles such as CKD or DM. National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov NCT02294643). Copyright © 2015. Published by Elsevier Inc.

  3. An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin K antagonist treatment strategy in subjects with atrial fibrillation who undergo percutaneous coronary intervention (PIONEER AF-PCI).

    Science.gov (United States)

    Gibson, C Michael; Mehran, Roxana; Bode, Christoph; Halperin, Johnathan; Verheugt, Freek; Wildgoose, Peter; van Eickels, Martin; Lip, Gregory Y H; Cohen, Marc; Husted, Steen; Peterson, Eric; Fox, Keith

    2015-04-01

    Guidelines recommendations regarding anticoagulant therapy after percutaneous coronary intervention (PCI) among patients with atrial fibrillation (AF) rely on retrospective, nonrandomized observational data. Currently, patients are treated with triple-therapy (dual antiplatelet therapy [DAPT] + oral anticoagulation therapy), but neither the duration of DAPT nor the level of anticoagulation has been studied in a randomized fashion. Recent studies also suggest dual pathway therapy with clopidogrel plus oral anticoagulation therapy may be superior, and other studies suggest that novel oral anticoagulants such as rivaroxaban may further improve patient outcomes. PIONEER AF-PCI (ClinicalTrials.gov NCT01830543) is an exploratory, open-label, randomized, multicenter clinical study assessing the safety of 2 rivaroxaban treatment strategies and 1 vitamin K antagonist (VKA) treatment strategy in subjects who have paroxysmal, persistent, or permanent nonvalvular AF and have undergone PCI with stent placement. Approximately 2,100 subjects will be randomized in a 1:1:1 ratio to receive either rivaroxaban 15 mg once daily plus clopidogrel 75 mg daily for 12 months (a WOEST trial-like strategy), or rivaroxaban 2.5 mg twice daily (with stratification to a prespecified duration of DAPT 1, 6, or 12 months, an ATLAS trial-like strategy), or dose-adjusted VKA once daily (with stratification to a prespecified duration of DAPT 1, 6, or 12 months, traditional triple therapy). All patients will be followed up for 12 months for the primary composite end point of Thrombolysis in Myocardial Infarction major bleeding, bleeding requiring medical attention, and minor bleeding (collectively, clinically significant bleeding). The PIONEER AF-PCI study is the first randomized comparison of VKA vs novel oral anticoagulant therapy in patients with NVAF receiving antiplatelet therapy after PCI to assess the relative risks of bleeding complications. Copyright © 2014 Elsevier Inc. All rights reserved.

  4. Efficacy and Tolerability Outcomes of a Phase II, Randomized, Open-Label, Multicenter Study of a New Water-Dispersible Pediatric Formulation of Dihydroartemisinin-Piperaquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in African Infants.

    Science.gov (United States)

    Gargano, Nicola; Madrid, Lola; Valentini, Giovanni; D'Alessandro, Umberto; Halidou, Tinto; Sirima, Sodiomon; Tshefu, Antoinette; Mtoro, Ali; Gesase, Samwel; Bassat, Quique

    2018-01-01

    Artemisinin combination therapies are considered the mainstay of malaria treatment, but pediatric-friendly formulations for the treatment of infants are scarce. We sought to evaluate the efficacy and safety of a new dispersible-tablet formulation of dihydroartemisinin/piperaquine phosphate (DHA/PQP) in comparison to the marketed tablet (Eurartesim) in the treatment of infants with uncomplicated Plasmodium falciparum malaria. Reported here are the results of a large phase II, randomized, open-label, multicenter trial conducted in African infants (6 to 12 months of age) from Mozambique, Burkina Faso, The Gambia, the Democratic Republic of the Congo, and Tanzania. Primary efficacy endpoint was the PCR-corrected adequate clinical and parasitological response (ACPR) at day 28. Analysis was performed for the intention-to-treat (ITT) and per-protocol (PP) populations. A total of 201 patients received the dispersible-tablet formulation, and 99 received the conventional one administered as crushed tablets. At day 28, the PCR-corrected ACPRs were 86.9% (ITT) and 98.3% (PP) in the dispersible-tablet group and 84.9% (ITT) and 100% (PP) in the crushed-tablet group. At day 42, these values were 85.9% (ITT) and 96.5% (PP) in the dispersible-tablet group and 82.8% (ITT) and 96.4% (PP) in the crushed-tablet group. The comparison between survival curves for time to new infections showed no statistically significant differences ( P = 0.409). The safety and tolerability profile for the two groups was similar in terms of type and frequency of adverse events and was consistent with that expected in African infants with malaria. A standard 3-day treatment with the new dispersible DHA/PQP formulation is as efficacious as the currently used tablet in African infants and has a comparable safety profile. (This trial was registered at ClinicalTrials.gov under registration no. NCT01992900.). Copyright © 2017 Gargano et al.

  5. An open-label, multicenter, flexible dose study to evaluate the efficacy and safety of Viagra (sildenafil citrate) in Korean men with erectile dysfunction and arterial hypertension who are taking antihypertensive agents.

    Science.gov (United States)

    Park, Hyun Jun; Park, Nam Cheol; Shim, Hong Bang; Park, Jong Kwan; Lee, Sung Won; Park, Kwangsung; Kim, Sae Woong; Moon, Ki Hak; Lee, Dong Hyeon; Yoon, Sang Jin

    2008-10-01

    Erectile dysfunction (ED) is common among men taking antihypertensive agents to control blood pressure. We evaluated the efficacy and safety of sildenafil citrate in men with ED taking antihypertensive agents. A total of 198 male subjects, aged 20 years and older were enrolled. This study was conducted for 10 weeks as an open-label, multicenter and flexible dose trial with a 2-week screening period and an 8-week treatment phase. Subjects were asked to complete Event Log Worksheets, as well as the International Index of Erectile Function (IIEF) and the Global Efficacy Assessment Questions (GEAQ) questionnaires during the study period. The average age among the 167 subjects who completed the study was 55.8 (31.7 to 77.1). The scores for questions 3 and 4 of IIEF improved from 2.3 and 1.8 at baseline to 3.7 and 3.4 at week 4 and 3.8 and 3.4 at week 8, respectively. There were 86.3% of the patients reported improved erectile function at week 8; 88.3% of the patients reported improved ability to achieve sexual intercourse at week 8. There were no significant differences observed in the responses to questions 3 and 4 of IIEF and GEAQ by the number of antihypertensive agents taken. The adverse events were facial flushing (20.1%), headache (11.7%), palpitation (5.0%), rhinitis (2.8%), URI (2.8%), dizziness (2.2%), dyspnea (2.2%), and nausea (1.7%). Sildenafil citrate is an effective treatment for ED; it is safe and well tolerated by patients with ED taking multiple antihypertensive agents for arterial hypertension.

  6. Effectiveness, pharmacokinetics, and safety of a new sustained-release leuprolide acetate 3.75-mg depot formulation for testosterone suppression in patients with prostate cancer: a Phase III, open-label, international multicenter study.

    Science.gov (United States)

    Marberger, Michael; Kaisary, Amir V; Shore, Neal D; Karlin, Gary S; Savulsky, Claudio; Mis, Ricard; Leuratti, Chiara; Germa, Josep R

    2010-04-01

    A microencapsulated, sustained-release formulation of leuprolide acetate 3.75 mg has been developed. This study investigated the effectiveness, pharmacokinetics, and safety profile of a 1-month leuprolide acetate 3.75-mg depot formulation for suppressing testosterone concentrations in patients with prostate cancer. This was a Phase III, open-label, international multicenter clinical trial. Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot. Plasma testosterone concentrations were determined at specific times throughout the study. The primary end point was the proportion of successful patients over the total number of evaluable patients (ie, patients with evaluable testosterone concentrations at all monthly assessments and no missing values due to treatment-related adverse events). Treatment success was defined as testosterone suppression below the clinical castration level (ie, n = 12), showed sustained release of leuprolide from the formulation. Values for AUC(0-t) calculated from day 0 to day 28, days 28 to 56, and days 56 to 84 were 25,976.5 (7892.0), 30,685.5 (9348.4), and 31,030.9 (10,745.0) pg/mL per day, respectively. The most common treatment-related adverse event was hot flashes (45.0% [72/160]). Fatigue, hyperhidrosis, night sweats, and headache each occurred in

  7. Open-label, randomized, multicenter, phase III study to evaluate the safety and efficacy of benzoyl peroxide gel in long-term use in patients with acne vulgaris: A secondary publication.

    Science.gov (United States)

    Kawashima, Makoto; Nagare, Toshitaka; Katsuramaki, Tsuneo

    2017-06-01

    An open-label, randomized, multicenter study was conducted to evaluate the safety and efficacy of long-term use of 2.5% and 5% benzoyl peroxide (BPO) gels administrated once daily for 52 weeks to Japanese patients with acne vulgaris. The efficacy of the study drugs was evaluated by counting inflammatory lesions and non-inflammatory lesions. Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values. In total, 458 subjects were included in the efficacy and safety analyses. The total lesion count, the efficacy end-point, was similarly changed both in the 2.5% and 5% BPO groups over the course of the study. The median rates of reduction from baseline to week 12 were approximately 65%. Thereafter, the counts were maintained at a reduced level without increasing until week 52. The median rates at week 52 were approximately 80%. Similar trends were observed for inflammatory and non-inflammatory lesion counts. Bacteriological evaluation indicated similar distribution of the minimum inhibitory concentration of each of the antibacterial drugs against Propionibacterium acnes between the values at baseline and at week 52, suggesting that long-term use did not result in changes in the drug sensitivity. The incidence of adverse events was 84.0% in the 2.5% BPO group and 87.2% in the 5% BPO group. Many of the adverse events occurred within the first month and were mild or moderate in severity and transient. The results suggest that both 2.5% and 5% BPO gels are effective and safe for long-term treatment of patients with acne vulgaris. © 2017 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.

  8. Tolerability and safety of Souvenaid in patients with mild Alzheimer's disease: results of multi-center, 24-week, open-label extension study.

    Science.gov (United States)

    Olde Rikkert, Marcel G M; Verhey, Frans R; Blesa, Rafael; von Arnim, Christine A F; Bongers, Anke; Harrison, John; Sijben, John; Scarpini, Elio; Vandewoude, Maurits F J; Vellas, Bruno; Witkamp, Renger; Kamphuis, Patrick J G H; Scheltens, Philip

    2015-01-01

    The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to improve synapse formation and function in patients with Alzheimer's disease (AD). Two double-blind randomized controlled trials (RCT) with Souvenaid of 12 and 24 week duration (Souvenir I and Souvenir II) showed that memory performance was improved in drug-naïve mild AD patients, whereas no effects on cognition were observed in a 24-week RCT (S-Connect) in mild to moderate AD patients using AD medication. Souvenaid was well-tolerated in all RCTs. In this 24-week open-label extension (OLE) study to the 24-week Souvenir II RCT, long-term safety and intake adherence of the medical food Souvenaid was evaluated. Patients with mild AD (n = 201) received Souvenaid once-daily during the OLE. Main outcome parameters were safety and product intake adherence. The memory domain z-score from a revised neuropsychological test battery was continued as exploratory parameter. Compared to the RCT, a similar (low) incidence and type of adverse events was observed, being mainly (68.3%) of mild intensity. Pooled data (RCT and OLE) showed that 48-week use of Souvenaid was well tolerated with high intake adherence (96.1%). Furthermore, a significant increase in the exploratory memory outcome was observed in both the active-active and control-active groups during Souvenaid intervention. Souvenaid use for up to 48-weeks was well tolerated with a favorable safety profile and high intake adherence. The findings in this OLE study warrant further investigation toward the long-term safety and efficacy of Souvenaid in a well-controlled, double-blind RCT.

  9. 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

  10. 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.

  11. Intravenous immunoglobulin for maintenance treatment of multifocal motor neuropathy: A multi-center, open-label, 52-week phase 3 trial.

    Science.gov (United States)

    Kuwabara, Satoshi; Misawa, Sonoko; Mori, Masahiro; Iwai, Yuta; Ochi, Kazuhide; Suzuki, Hidekazu; Nodera, Hiroyuki; Tamaoka, Akira; Iijima, Masahiro; Toda, Tatsushi; Yoshikawa, Hiroo; Kanda, Takashi; Sakamoto, Ko; Kusunoki, Susumu; Sobue, Gen; Kaji, Ryuji

    2018-04-10

    Intravenous immunoglobulin (IVIg) therapy is currently the only established treatment in patients with multifocal motor neuropathy (MMN), and many patients have an IVIg-dependent fluctuation. We aimed to investigate the efficacy and safety of every 3 week IVIg (1.0 g/kg) for 52 weeks. This study was an open-label phase 3 clinical trial, enrolling 13 MMN patients. After an induction IVIg therapy (0.4 g/kg/d for 5 consecutive days), maintenance dose (1.0 g/kg) was given every 3 weeks for 52 weeks. The major outcome measures were the Medical Research Council (MRC) sum score and hand-grip strength at week 52. This trial is registered with ClinicalTrials.gov, number NCT01827072. At week 52, 11 of the 13 patients completed the study, and all 11 had a sustained improvement. The mean (SD) MRC sum score was 85.6 (8.7) at the baseline, and 90.6 (12.8) at week 52. The mean grip strength was 39.2 (30.0) kPa at the baseline and 45.2 (32.8) kPa at week 52. Two patients dropped out because of adverse event (dysphagia) and decision of an investigator, respectively. Three patients developed coronary spasm, dysphagia, or inguinal herniation, reported as the serious adverse events, but considered not related with the study drug. The other adverse effects were mild and resolved by the end of the study period. Our results show that maintenance treatment with 1.0 g/kg IVIg every 3 week is safe and efficacious for MMN patients up to 52 weeks. Further studies are required to investigate optimal dose and duration of maintenance IVIg for MMN. © 2018 The Authors. Journal of the Peripheral Nervous System published by Wiley Periodicals, Inc. on behalf of Peripheral Nerve Society.

  12. Long-term exposure and safety of lacosamide monotherapy for the treatment of partial-onset (focal) seizures: Results from a multicenter, open-label trial.

    Science.gov (United States)

    Vossler, David G; Wechsler, Robert T; Williams, Paulette; Byrnes, William; Therriault, Sheila

    2016-10-01

    To assess long-term use and safety of lacosamide (LCM) ≤800 mg/day monotherapy in patients with partial-onset seizures (POS) enrolled previously in a historical-controlled, conversion-to-monotherapy study (SP902; NCT00520741). Patients completing or exiting SP902 with LCM as monotherapy or as adjunctive therapy were eligible to enter this 2-year open-label extension (OLE) trial (SP904; NCT00530855) at a starting dose ±100 mg/day of their final SP902 dose. Investigators could adjust the LCM dose to 100-800 mg/day and add up to two antiepileptic drugs to optimize tolerability and seizure reduction. Three hundred twenty-two patients received LCM: 210 patients (65.2%) completed and 112 (34.8%) discontinued, most commonly owing to withdrawal of consent (9.3%). Two hundred fifty-eight patients (80.1%) had ≥1 year of and 216 (67.1%) had ≥2 years of LCM exposure, of whom 179/258 (69.4%) achieved LCM monotherapy lasting for any 12-month period, and 126/216 (58.3%) patients exposed for ≥24 months achieved LCM monotherapy for any 24-month period. Total exposure = 525.5 patient-years. The median modal dose was 500 mg/day. Two hundred ninety-two patients (90.7%) achieved LCM monotherapy at some point during the study. Sixty-five of 87 patients who exited and 193/235 who completed SP902 were exposed for ≥12 months, and 43.1% and 78.2%, respectively, achieved LCM monotherapy for ≥12 months. Median LCM monotherapy duration was 587.0 days (2-791 days); 91.0% of patients reported treatment-emergent adverse events, of which the most common were dizziness (27.3%), headache (17.1%), and nausea (14.3%). Compared with the SP902 study baseline, 74.2% of patients had a ≥50% seizure reduction and 5.6% were seizure-free at 24 months. The majority of patients were receiving LCM monotherapy at 0, 12, and 24 months in this OLE. Lacosamide monotherapy (median dose of 500 mg/day) had a safety profile similar to that of adjunctive therapy studies. These results support the use of

  13. Safety and tolerability of aripiprazole for irritability in pediatric patients with autistic disorder: a 52-week, open-label, multicenter study.

    Science.gov (United States)

    Marcus, Ronald N; Owen, Randall; Manos, George; Mankoski, Raymond; Kamen, Lisa; McQuade, Robert D; Carson, William H; Findling, Robert L

    2011-09-01

    Evaluate the long-term safety and tolerability of aripiprazole in the treatment of irritability in pediatric subjects (6-17 years) with autistic disorder. A 52-week, open-label, flexibly dosed (2-15 mg/d) study of the safety and tolerability of aripiprazole in outpatients with a DSM-IV-TR diagnosis of autistic disorder who either had completed 1 of 2 antecedent, 8-week randomized trials or were enrolled de novo (ie, not treated in the randomized trials). Safety and tolerability measures included incidences of adverse events, extrapyramidal symptoms, weight, metabolic measures, vital signs, and other clinical assessments. Subjects were enrolled between September 2006 and June 2009. Three hundred thirty subjects entered the treatment phase: 86 de novo, 174 prior aripiprazole, and 70 prior placebo. A total of 199 (60.3%) subjects completed 52 weeks of treatment. Adverse events were experienced by 286/330 subjects (86.7%). Common adverse events included weight increase, vomiting, nasopharyngitis, increased appetite, pyrexia, upper respiratory tract infection, and insomnia. Discontinuations due to adverse events occurred in 35/330 randomized subjects (10.6%)-most commonly aggression and weight increase. One patient discontinued from the study due to a laboratory-related adverse event (moderately increased alanine transaminase and aspartate transaminase). Nine subjects experienced serious adverse events-most frequently aggression. Extrapyramidal symptoms-related adverse events occurred in 48/330 subjects (14.5%)-most commonly tremor (3.0%), psychomotor hyperactivity (2.7%), akathisia (2.4%), and dyskinesia (not tardive, 2.4%). At > 9 months' aripiprazole exposure (n = 220), mean change in body weight z score was 0.33 and body mass index z score was 0.31. The percentages of subjects with clinically significant fasting metabolic abnormalities at > 9 months were 2% for glucose, 5% for total cholesterol, 7% for low-density lipoprotein cholesterol, 30% for high

  14. Adjunctive levetiracetam in children, adolescents, and adults with primary generalized seizures: Open-label, noncomparative, multicenter, long-term follow-up study.

    LENUS (Irish Health Repository)

    Delanty, Norman

    2012-02-01

    Purpose: To evaluate the long-term efficacy and tolerability of adjunctive levetiracetam (LEV) in patients with uncontrolled idiopathic generalized epilepsy (IGE). Methods: This phase III, open-label, long-term, follow-up study (N167; NCT00150748) enrolled patients (4 to <65 years) with primary generalized seizures (tonic-clonic, myoclonic, absence). Patients received adjunctive LEV at individualized doses (1,000-4,000 mg\\/day; 20-80 mg\\/kg\\/day for children\\/adolescents weighing <50 kg). Efficacy results are reported for all seizure types [intention-to-treat (ITT) population, N = 217] and subpopulations with tonic-clonic (n = 152), myoclonic (n = 121), and\\/or absence (n = 70) seizures at baseline. Key Findings: One hundred twenty-five (57.6%) of 217 patients were still receiving treatment at the end of the study. Mean (standard deviation, SD) LEV dose was 2,917.5 (562.9) mg\\/day. Median (Q1-Q3) exposure to LEV was 2.1 (1.5-2.8) years, and the maximum duration was 4.6 years. Most patients were taking one (124\\/217, 57.1%) or >\\/=2 (92\\/217, 42.4%) concomitant antiepileptic drugs (AEDs). Seizure freedom of >\\/=6 months (all seizure types; primary efficacy end point) was achieved by 122 (56.2%) of 217 patients, and 49 (22.6%) of 217 patients had complete seizure freedom. Seizure freedom of >\\/=6 months from tonic-clonic, myoclonic, and absence seizures was achieved by 95 (62.5%) of 152, 75 (62.0%) of 121, and 44 (62.9%) of 70 patients, respectively. Mean (SD) maximum seizure freedom duration was 371.7 (352.4) days. At least one treatment-emergent adverse event (TEAE) was reported by 165 (76%) of 217 patients; most TEAEs were mild\\/moderate in severity, with no indication of an increased incidence over time. Seventeen (7.8%) of 217 patients discontinued medication because of TEAEs. The most common psychiatric TEAEs were depression (16\\/217, 7.4%), insomnia (9\\/217, 4.1%), nervousness (8\\/217, 3.7%), and anxiety (7\\/217, 3.2%). Significance: Adjunctive

  15. An open-label multicenter study to assess the safety of dextromethorphan/quinidine in patients with pseudobulbar affect associated with a range of underlying neurological conditions.

    Science.gov (United States)

    Pattee, Gary L; Wymer, James P; Lomen-Hoerth, Catherine; Appel, Stanley H; Formella, Andrea E; Pope, Laura E

    2014-11-01

    Pseudobulbar affect (PBA) is associated with neurological disorders or injury affecting the brain, and characterized by frequent, uncontrollable episodes of crying and/or laughing that are exaggerated or unrelated to the patient's emotional state. Clinical trials establishing dextromethorphan and quinidine (DM/Q) as PBA treatment were conducted in patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS). This trial evaluated DM/Q safety in patients with PBA secondary to any neurological condition affecting the brain. To evaluate the safety and tolerability of DM/Q during long-term administration to patients with PBA associated with multiple neurological conditions. Fifty-two-week open-label study of DM/Q 30/30 mg twice daily. Safety measures included adverse events (AEs), laboratory tests, electrocardiograms (ECGs), vital signs, and physical examinations. #NCT00056524. A total of 553 PBA patients with >30 different neurological conditions enrolled; 296 (53.5%) completed. The most frequently reported treatment-related AEs (TRAEs) were nausea (11.8%), dizziness (10.5%), headache (9.9%), somnolence (7.2%), fatigue (7.1%), diarrhea (6.5%), and dry mouth (5.1%). TRAEs were mostly mild/moderate, generally transient, and consistent with previous controlled trials. Serious AEs (SAEs) were reported in 126 patients (22.8%), including 47 deaths, mostly due to ALS progression and respiratory failure. No SAEs were deemed related to DM/Q treatment by investigators. ECG results suggested no clinically meaningful effect of DM/Q on myocardial repolarization. Differences in AEs across neurological disease groups appeared consistent with the known morbidity of the primary neurological conditions. Study interpretation is limited by the small size of some disease groups, the lack of a specific efficacy measure and the use of a DM/Q dose higher than the eventually approved dose. DM/Q was generally well tolerated over this 52 week trial in patients with PBA

  16. Pharmacokinetic and safety profile of tofacitinib in children with polyarticular course juvenile idiopathic arthritis: results of a phase 1, open-label, multicenter study.

    Science.gov (United States)

    Ruperto, Nicolino; Brunner, Hermine I; Zuber, Zbigniew; Tzaribachev, Nikolay; Kingsbury, Daniel J; Foeldvari, Ivan; Horneff, Gerd; Smolewska, Elzbieta; Vehe, Richard K; Hazra, Anasuya; Wang, Rong; Mebus, Charles A; Alvey, Christine; Lamba, Manisha; Krishnaswami, Sriram; Stock, Thomas C; Wang, Min; Suehiro, Ricardo; Martini, Alberto; Lovell, Daniel J

    2017-12-28

    Juvenile idiopathic arthritis (JIA) is the most common pediatric rheumatic disease and a leading cause of childhood disability. The objective of this study was to characterize the PK, safety, and taste acceptability of tofacitinib in patients with JIA. This Phase 1, open-label, multiple-dose (twice daily [BID] for 5 days) study of tofacitinib in patients with active (≥ 5 joints) polyarticular course JIA was conducted from March 2013-December 2015. Patients were allocated to one of three age-based cohorts: Cohort 1, 12 to Tofacitinib was administered according to age and body weight as tablets or oral solution (grape flavor). PK were assessed on Day 5; safety was assessed at screening, Day 1, and Day 5. Taste acceptability of the oral solution was evaluated. Twenty-six patients (age range 2-17 years) were enrolled: Cohort 1, N = 8; Cohort 2, N = 9; Cohort 3, N = 9; median tofacitinib doses were 5.0, 2.5, and 3.0 mg BID, respectively. The higher median tofacitinib dose in Cohort 3 versus Cohort 2 reflected implementation of an amended dosing scheme following an interim PK analysis after Cohort 2 recruitment. Geometric mean AUC at steady state (AUC tau ) was 156.6 ng•h/mL in Cohort 1, 118.8 ng•h/mL in Cohort 2, and 142.5 ng•h/mL in Cohort 3; C max (ng/mL) was 47.0, 41.7, and 66.2, respectively. C trough , C min , and t 1/2 were similar in Cohorts 2 and 3, but higher in Cohort 1. Median time to C max (T max ) was similar between cohorts. Apparent clearance and volume of distribution decreased with decreasing age. Tofacitinib was well tolerated, with no serious adverse events or discontinuations due to adverse events reported. Taste acceptability was confirmed. PK findings from this study in children with polyarticular course JIA established dosing regimens and acceptable taste for use in subsequent studies within the tofacitinib pediatric development program. ClinicalTrials.gov: NCT01513902 .

  17. A 6-week, multicenter, randomized, double-masked, parallel-group study comparing travoprost 0.004% to latanoprost 0.005% followed by 6-week, open-label treatment with travoprost 0.004%.

    Science.gov (United States)

    Maul, Eugenio; Carrasco, Félix Gil; Costa, Vital Paulino; Casiraghi, Javier F; Vargas, Enrique; Sarmina, Judith S; Mayol, Renato

    2007-09-01

    The aim of this study was to compare the tolerability and efficacy of once-daily travoprost 0.004% versus latanoprost 0.005% for 6 weeks followed by 6 weeks of once-daily travoprost 0.004% in decreasing intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). This multicenter, randomized, doublemasked, active-controlled, parallel-group trial was conducted at 32 centers across Latin America. Patients aged > or =18 years with OAG or OH were randomly assigned to receive topical travoprost 0.004% or latanoprost 0.005% 1 drop QD (9 PM) for 6 weeks (masked phase). At 6 weeks, all patients were assigned to receive open-label travoprost 0.004% 1 drop QD (9 PM) for 6 additional weeks (open-label phase). Study visits were scheduled at weeks 1, 2, 4, 6, 8, and 12. At each study visit, IOP was measured at 5 PM (+/-1 hour; approximately 20 hours after study drug administration). IOP changes from baseline were combined (pooled) from the 1-, 2-, 4-, and 6-week data to provide a comparison between the 2 treatment groups. Ocular adverse events (AEs) were monitored using slit-lamp examination. A total of 302 patients were enrolled (travoprost group, 155 patients; latanoprost group, 147 patients). The mean (SD) age of the travoprost group was 61.9 (10.6) years; 60.6% were female; and 47.1% were white. The mean (SD) age of the latanoprost group was 60.5 (12.4) years; 62.6% were female; and 49.0% were white. Mean IOP values were not significantly different between the travoprost and latanoprost groups at baseline (24.7 vs 24.2 mm Hg) or 6 weeks; however, the between-group difference in reductions from baseline in pooled IOP during the masked phase of the study was statistically significant (-8.3 vs -7.5 mm Hg; P = 0.009). At weeks 6 and 12, mean lOP levels were 16.1 and 16.2 mm Hg, respectively, in the travoprost group and 16.4 and 16.1 mm Hg in the group that was switched from latanoprost to travoprost (all, P = NS). The most common ocular AEs

  18. Advantages with prophylactic PEG-rhG-CSF versus rhG-CSF in breast cancer patients receiving multiple cycles of myelosuppressive chemotherapy: an open-label, randomized, multicenter phase III study.

    Science.gov (United States)

    Xie, Jie; Cao, Jun; Wang, Jing-Fen; Zhang, Bai-Hong; Zeng, Xiao-Hua; Zheng, Hong; Zhang, Yang; Cai, Li; Wu, Yu-Dong; Yao, Qiang; Zhao, Xiao-Chun; Mao, Wei-Dong; Jiang, Ai-Mei; Chen, Shao-Shui; Yang, Shun-E; Wang, Shu-Sen; Wang, Jian-Hong; Pan, Yue-Yin; Ren, Bi-Yong; Chen, Yan-Ju; Ouyang, Li-Zhi; Lei, Kai-Jian; Gao, Jing-Hua; Huang, Wen-He; Huang, Zhan; Shou, Tao; He, Yan-Ling; Cheng, Jing; Sun, Yang; Li, Wei-Ming; Cui, Shu-de; Wang, Xin; Rao, Zhi-Guo; Ma, Hu; Liu, Wei; Wu, Xue-Yong; Shen, Wei-Xi; Cao, Fei-Lin; Xiao, Ze-Min; Wu, Biao; Tian, Shu-Yan; Meng, Dong; Shen, Peng; Wang, Bi-Yun; Wang, Zhonghua; Zhang, Jian; Wang, Leiping; Hu, Xi-Chun

    2018-04-01

    PEG-rhG-CSF reduces neutropenia and improves chemotherapy safety. In China's registration trial (CFDA: 2006L01305), we assessed its efficacy and safety against rhG-CSF, and prospectively explored its value over multiple cycles of chemotherapy. In this open-label, randomized, multicenter phase 3 study, breast cancer patients (n = 569) were randomized to receive PEG-rhG-CSF 100 µg/kg, PEG-rhG-CSF 6 mg, or rhG-CSF 5 µg/kg/d after chemotherapy. The primary endpoints were the incidence and duration of grade 3/4 neutropenia during cycle 1. Secondary endpoints included the incidence and duration of grade 3/4 neutropenia during cycles 2-4, the incidence of febrile neutropenia, and the safety. A once-per-cycle PEG-rhG-CSF at either 100 µg/kg or 6 mg was not different from daily injections of rhG-CSF for either incidence or duration of grade 3/4 neutropenia. Interestingly, a substantial difference was noted during cycle 2, and the difference became bigger over cycles 3-4, reaching a statistical significance at cycle 4 in either incidence (P = 0.0309) or duration (P = 0.0289) favoring PEG-rhG-CSF. A significant trend toward a lower incidence of all-grade adverse events was noted at 129 (68.98%), 142 (75.53%), and 160 (82.47%) in the PEG-rhG-CSF 100 µg/kg and 6 mg and rhG-CSF groups, respectively (P = 0.0085). The corresponding incidence of grade 3/4 drug-related adverse events was 2/187 (1.07%), 1/188 (0.53%), and 8/194 (4.12%), respectively (P = 0.0477). Additionally, PFS in metastatic patients preferred PEG-rhG-CSF to rhG-CSF despite no significance observed by Kaplan-Meier analysis (n = 49, P = 0.153). PEG-rhG-CSF is a more convenient and safe formulation and a more effective prophylactic measure in breast cancer patients receiving multiple cycles of chemotherapy.

  19. Transdermal granisetron versus palonosetron for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: a multicenter, randomized, open-label, cross-over, active-controlled, and phase IV study.

    Science.gov (United States)

    Seol, Young Mi; Kim, Hyo Jeong; Choi, Young Jin; Lee, Eun Mi; Kim, Yang Soo; Oh, Sung Yong; Koh, Su Jin; Baek, Jin Ho; Lee, Won Sik; Joo, Young Don; Lee, Hyun Gi; Yun, Eun Young; Chung, Joo Seop

    2016-02-01

    Palonosetron is the second-generation 5-hydroxytryptamine 3 receptor antagonist (5-HT3RA) that has shown better efficacy than the first-generation 5-HT3RA for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy (MEC). Granisetron transdermal delivery system (GTDS), a novel transdermal formulation, was developed to deliver granisetron continuously over 7 days. This study compared the efficacy and tolerability of the GTDS to palonosetron for the control of CINV following MEC. A total of 196 patients were randomized to GP or PG group. In this multicenter, randomized, open-label, cross-over, active-controlled, Phase IV study, GP group was assigned to receive transdermal granisetron (one GTDS patch, 7 days) in the first chemotherapy cycle, palonosetron (iv 0.25 mg/day, 1 days) in the second chemotherapy cycle before receiving MEC, and PG group was assigned to receive palonosetron in the first cycle and GTDS in the second cycle. Primary endpoint was the percentage of chemotherapy cycles achieving complete response (CR; defined as no emetic episodes and no rescue medication use) during the acute phase (0-24 h in post-chemotherapy; non-inferiority comparison with palonosetron). Total 333 cycles (165 in GTDS and 168 in palonosetron) were included in the per protocol analysis. The GTDS cycles showed non-inferiority to palonosetron cycles during the acute phase: CR was achieved by 124 (75.2 %) patients in the GTDS cycles and 134 (79.8 %) patients in the palonosetron cycles (treatment difference, -4.6 %; 95 % confidence interval, -13.6-4.4). There was no significant difference in CR rate during acute phase after the end of the first and second chemotherapy cycle between GP and PG group (p = 0.405, p = 0.074). Patients' satisfaction, assessed using Functional Living Index-Emesis (FLI-E), GTDS cycle were higher than those of palonosetron cycle in GP group (FLI-E score; median 1549.5 in GTDS cycle, median 1670

  20. A multicenter, open-label, long-term safety and tolerability study of DFN-02, an intranasal spray of sumatriptan 10 mg plus permeation enhancer DDM, for the acute treatment of episodic migraine.

    Science.gov (United States)

    Munjal, Sagar; Brand-Schieber, Elimor; Allenby, Kent; Spierings, Egilius L H; Cady, Roger K; Rapoport, Alan M

    2017-12-01

    DFN-02 is a novel intranasal spray formulation composed of sumatriptan 10 mg and a permeation-enhancing excipient comprised of 0.2% 1-O-n-Dodecyl-β-D-Maltopyranoside (DDM). This composition of DFN-02 allows sumatriptan to be rapidly absorbed into the systemic circulation and exhibit pharmacokinetics comparable to subcutaneously administered sumatriptan. Rapid rate of absorption is suggested to be important for optimal efficacy. The objective of this study was to evaluate the safety and tolerability of DFN-02 (10 mg) in the acute treatment of episodic migraine with and without aura over a 6-month period based on the incidence of treatment-emergent adverse events and the evaluation of results of clinical laboratory tests, vital signs, physical examination, and electrocardiograms. This was a multi-center, open-label, repeat-dose safety study in adults with episodic migraine with and without aura. Subjects diagnosed with migraine with or without aura according to the criteria set forth in the International Classification of Headache Disorders, 2nd edition, who experienced 2 to 6 attacks per month with fewer than 15 headache days per month and at least 48 headache-free hours between attacks, used DFN-02 to treat their migraine attacks acutely over the course of 6 months. A total of 173 subjects was enrolled, 167 (96.5%) subjects used at least 1 dose of study medication and were evaluable for safety, and 134 (77.5%) subjects completed the 6-month study. A total of 2211 migraine attacks was reported, and 3292 doses of DFN-02 were administered; mean per subject monthly use of DFN-02 was 3.6 doses. Adverse events were those expected for triptans, as well as for nasally administered compounds. No new safety signals emerged. Dysgeusia and application site pain were the most commonly reported treatment-emergent adverse events over 6 months (21% and 30.5%, respectively). Most of the treatment-emergent adverse events were mild. There were 5 serious adverse events, all

  1. Multicenter, Randomized, Open-Label, Phase III Trial of Decitabine Versus Patient Choice, With Physician Advice, of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia

    Science.gov (United States)

    Kantarjian, Hagop M.; Thomas, Xavier G.; Dmoszynska, Anna; Wierzbowska, Agnieszka; Mazur, Grzegorz; Mayer, Jiri; Gau, Jyh-Pyng; Chou, Wen-Chien; Buckstein, Rena; Cermak, Jaroslav; Kuo, Ching-Yuan; Oriol, Albert; Ravandi, Farhad; Faderl, Stefan; Delaunay, Jacques; Lysák, Daniel; Minden, Mark; Arthur, Christopher

    2012-01-01

    Purpose This multicenter, randomized, open-label, phase III trial compared the efficacy and safety of decitabine with treatment choice (TC) in older patients with newly diagnosed acute myeloid leukemia (AML) and poor- or intermediate-risk cytogenetics. Patients and Methods Patients (N = 485) age ≥ 65 years were randomly assigned 1:1 to receive decitabine 20 mg/m2 per day as a 1-hour intravenous infusion for five consecutive days every 4 weeks or TC (supportive care or cytarabine 20 mg/m2 per day as a subcutaneous injection for 10 consecutive days every 4 weeks). The primary end point was overall survival (OS); the secondary end point was the complete remission (CR) rate plus the CR rate without platelet recovery (CRp). Adverse events (AEs) were recorded. Results The primary analysis with 396 deaths (81.6%) showed a nonsignificant increase in median OS with decitabine (7.7 months; 95% CI, 6.2 to 9.2) versus TC (5.0 months; 95% CI, 4.3 to 6.3; P = .108; hazard ratio [HR], 0.85; 95% CI, 0.69 to 1.04). An unplanned analysis with 446 deaths (92%) indicated the same median OS (HR, 0.82; 95% CI, 0.68 to 0.99; nominal P = .037). The CR rate plus CRp was 17.8% with decitabine versus 7.8% with TC (odds ratio, 2.5; 95% CI, 1.4 to 4.8; P = .001). AEs were similar for decitabine and cytarabine, although patients received a median of four cycles of decitabine versus two cycles of TC. The most common drug-related AEs with decitabine were thrombocytopenia (27%) and neutropenia (24%). Conclusion In older patients with AML, decitabine improved response rates compared with standard therapies without major differences in safety. An unplanned survival analysis showed a benefit for decitabine, which was not observed at the time of the primary analysis. PMID:22689805

  2. An open-label, multicenter study to evaluate the safe and effective use of the single-use autoinjector with an Avonex® prefilled syringe in multiple sclerosis subjects

    Directory of Open Access Journals (Sweden)

    Tuccillo Dianne

    2011-10-01

    Full Text Available Abstract Background The ability to self-inject in patients with multiple sclerosis (MS has been associated with a reduced risk of missed injections and drug discontinuation, and a beneficial effect on patients' independence. However, injection anxiety, needle phobia and disease-related disability are major barriers to a patient's ability to self-administer treatment. Use of an autoinjector may improve patients' ability to self-inject. This study evaluated the safe and effective use of Avonex Pen™ (prefilled pen, a single use autoinjector, for intramuscular delivery of interferon beta-1a (IM IFNβ-1a, Avonex in MS patients. Methods This was a Phase IIIb, open-label, single-country, multicenter trial in MS patients currently using IM IFNβ-1a prefilled syringes. Patients received weekly 30 mcg IM IFNβ-1a treatment over 4 weeks. On Day 1, patients self-administered IM IFNβ-1a using a prefilled syringe at the clinic. On Day 8, patients received training on the prefilled pen and self-administered IM IFNβ-1a using the device. On Day 15, patients self-administered IM IFNβ-1a at home using the prefilled pen. A final injection occurred at the clinic on Day 22 when patients self-administered IM IFNβ-1a using the prefilled pen while clinic staff observed and completed a detailed questionnaire documenting patients' ability to self-inject with the device. Serum neopterin levels were evaluated pre and post-injection on Days 1 and 8. Adverse events were monitored throughout. Results Seventy-one (96% patients completed the study. The overall success rate in safely and effectively using the prefilled pen was 89%. No device malfunctions occurred. One unsuccessful administration occurred at Day 22 due to patient error; no patient injury resulted. Patients gave the prefilled pen high ratings (8.7-9.3 on a 10-point scale for ease of use (0 = extremely difficult, 10 = extremely easy. Ninety-four percent of patients preferred the prefilled pen over the

  3. Safety and tolerability of pasireotide long-acting release in acromegaly-results from the acromegaly, open-label, multicenter, safety monitoring program for treating patients who have a need to receive medical therapy (ACCESS) study.

    Science.gov (United States)

    Fleseriu, Maria; Rusch, Elisha; Geer, Eliza B

    2017-01-01

    Pasireotide long-acting release is a somatostatin analog that is indicated for treatment of patients with acromegaly. This analysis documents the safety of pasireotide long-acting release in patients with acromegaly enrolled in the ACCESS trial (ClinicalTrials.gov identifier: NCT01995734). ACCESS is an open-label, multicenter, single-arm, expanded-treatment protocol designed to provide patients access to pasireotide long-acting release pending regulatory approval. Patients received pasireotide long-acting release 40 mg administered intramuscularly every 28 days. The primary outcome was the proportion of patients having a treatment-emergent grade ≥3 or serious adverse event. Efficacy data were not collected. Forty-four adult patients with active acromegaly were enrolled in the study for an average of 37.6 weeks (range, 4-70 weeks). Twenty-five grade ≥3 treatment-emergent adverse events were reported in 11 patients (25.0 %), 3 of whom (27.3 %) experienced grade ≥3 hyperglycemia. In patients treated with pasireotide long-acting release for ≥3 months (n = 42), mean glycated hemoglobin and fasting plasma glucose levels increased significantly from 5.9 % and 100.4 mg/dL at baseline to 6.8 % and 135.9 mg/dL at 3 months, respectively. Ten patients (22.7 %) were treated with pasireotide long-acting release for ≥15 months, after which mean glycated hemoglobin and fasting plasma glucose levels were 6.3 % and 123 mg/dL, respectively. Twenty-one patients (48 %) initiated antidiabetic medication. Grade ≥3 adverse events (primary outcome) were reported in 25.0 % of acromegaly patients treated with pasireotide long-acting release in a clinical setting. Hyperglycemia-related adverse events were reported in 45.5 % of patients, but were typically manageable, supporting the role of pasireotide long-acting release as a safe treatment option for acromegaly patients.

  4. A highly hydrolyzed formula based on whey protein with the prebiotics galactooligosaccharides and fructooligosaccharides effectively abolishes the symptoms of atopic dermatitis: Results of a multicenter open-label trial in Russia

    Directory of Open Access Journals (Sweden)

    A. N. Pampura

    2014-01-01

    Full Text Available Most cases of atopic dermatitis are caused by allergy to cow’s milk proteins in babies in their first year of life. Dietotherapy with highly hydrolyzed formulas is the basis for timely and adequate medical care to these children. The objective of the open-label multicenter prospective postregistration trial was to evaluate the efficacy of a formula based on the in-depth hydrolysis of whey proteins with the prebiotics GOS/lcFOS 0,8 g/100 ml for infants within their first year of life who received artificial nutrition and suffered from topical dermatitis presumably associated with allergy to cow’s milk proteins. The trial enrolled 51 babies aged 193,64 (SD 73,95 days with mild and moderate atopic dermatitis (SCORAD<40. Results. During a 4-week dietotherapy cycle, there was abolishment of the skin symptoms of atopic dermatitis (SCORAD 26,66 (SD 9,19 and 6,63 (SD 4,36 at the beginning and end of the trial and a reduction in the needs for topical glucocorticosteroids, zinc-containing topical agents and antihistamines (p<0,01. The individual visual analogue scale efficiency of the dietotherapy was 8,53 (SD 1,51 and 8,72 (SD 1,20 scores as assessed by the parents and physicians, respectively. During the dietotherapy, the physiological rate of defecations was 1,88 (SD 0,94 times/day, the characteristics of stool significantly improved. The average daily formula intake was 786,13 (SD 169,21 ml. Weight-for-height in all the infants was in the normal range. Conclusion. The test formula is well tolerated and effective in more than 90% of the infants with atopic dermatitis presumably associated with allergy to cow’s milk proteins and ensures a child’s growth and development. 

  5. BP-C1 in the treatment of patients with stage IV breast cancer: a randomized, double-blind, placebo-controlled multicenter study and an additional open-label treatment phase

    Directory of Open Access Journals (Sweden)

    Larsen S

    2014-11-01

    Full Text Available Stig Larsen,1 Kritiya Butthongkomvong,2 Alexey Manikhas,3 Ekaterina Trishkina,4 Elena Poddubuskaya,5 Marina Matrosova,6 Vichien Srimuninnimit,7 Steen Lindkær-Jensen81Department of Controlled Clinical Trials and Biostatistics, Centre for Epidemiology and Biostatistics, University of Life Science, Oslo, Norway; 2Udonthani Cancer Hospital, Udonthani, Thailand; 3Department of Oncology, City Clinical Oncology, Dispensary, St Petersburg, Russia; 4Department of Oncology, Leningrad Regional Oncology Centre, St Petersburg, Russia; 5Department of Oncology, Unit of Russian Academy of Medical Science, Moscow, Russia; 6Department of Oncology, N Novgorod Regional Oncology Dispensary, Novgorod, Russia; 7Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand; 8Department of Surgery and Cancer, Imperial College, Hammersmith Hospital, London, UKAbstract: The aims were to compare the efficacy and tolerability of a new benzene-poly-carboxylic acids complex with cis-diammineplatinum (II dichloride (BP-C1 versus placebo and to investigate the long-term tolerability of BP-C1 in the treatment of patients with metastatic breast cancer.Material and methods: A randomized, double-blind, placebo-controlled multicenter study was performed with a semi-crossover design. Patients allocated to placebo switched to BP-C1 after 32 days of treatment. Patients who completed 32 days of BP-C1 treatment were offered the opportunity to continue on BP-C1 for an additional 32 days in an open-label extension. Patients were then followed up for another 28 days. Thirty patients were given daily intramuscular injections of 0.035 mg/kg of body weight BP-C1 or placebo for 32 days. Biochemistry, hematology, National Cancer Institute Common Terminology Criteria for Adverse Events (CTC-NCI, European Organisation for Research and Treatment of Cancer quality of life questionnaire (QOL-C30 and the breast-cancer–specific BR23 data were recorded at

  6. An Open-Label, Multicenter, Randomized, Phase II Study of Pazopanib in Combination with Pemetrexed in First-Line Treatment of Patients with Advanced-Stage Non-Small-Cell Lung Cancer

    DEFF Research Database (Denmark)

    Scagliotti, Giorgio V; Felip, Enriqueta; Besse, Benjamin

    2013-01-01

    This randomized open-label phase II study evaluated the efficacy, safety, and tolerability of pazopanib in combination with pemetrexed compared with the standard cisplatin/pemetrexed doublet in patients with previously untreated, advanced, nonsquamous non-small-cell lung cancer....

  7. Bolting multicenter solutions

    Energy Technology Data Exchange (ETDEWEB)

    Bena, Iosif [Institut de Physique Théorique, Université Paris Saclay, CEA, CNRS, 91191 Gif-sur-Yvette Cedex (France); Bossard, Guillaume [Centre de Physique Théorique, Ecole Polytechnique, CNRS, Université Paris-Saclay, 91128 Palaiseau Cedex (France); Katmadas, Stefanos; Turton, David [Institut de Physique Théorique, Université Paris Saclay, CEA, CNRS, 91191 Gif-sur-Yvette Cedex (France)

    2017-01-30

    We introduce a solvable system of equations that describes non-extremal multicenter solutions to six-dimensional ungauged supergravity coupled to tensor multiplets. The system involves a set of functions on a three-dimensional base metric. We obtain a family of non-extremal axisymmetric solutions that generalize the known multicenter extremal solutions, using a particular base metric that introduces a bolt. We analyze the conditions for regularity, and in doing so we show that this family does not include solutions that contain an extremal black hole and a smooth bolt. We determine the constraints that are necessary to obtain smooth horizonless solutions involving a bolt and an arbitrary number of Gibbons-Hawking centers.

  8. Food Labels

    Science.gov (United States)

    ... Staying Safe Videos for Educators Search English Español Food Labels KidsHealth / For Teens / Food Labels What's in ... to have at least 95% organic ingredients. Making Food Labels Work for You The first step in ...

  9. Effect of mirtazapine versus selective serotonin reuptake inhibitors on benzodiazepine use in patients with major depressive disorder: a pragmatic, multicenter, open-label, randomized, active-controlled, 24-week trial.

    Science.gov (United States)

    Hashimoto, Tasuku; Shiina, Akihiro; Hasegawa, Tadashi; Kimura, Hiroshi; Oda, Yasunori; Niitsu, Tomihisa; Ishikawa, Masatomo; Tachibana, Masumi; Muneoka, Katsumasa; Matsuki, Satoshi; Nakazato, Michiko; Iyo, Masaomi

    2016-01-01

    This study aimed to evaluate whether selecting mirtazapine as the first choice for current depressive episode instead of selective serotonin reuptake inhibitors (SSRIs) reduces benzodiazepine use in patients with major depressive disorder (MDD). We concurrently examined the relationship between clinical responses and serum mature brain-derived neurotrophic factor (BDNF) and its precursor, proBDNF. We conducted an open-label randomized trial in routine psychiatric practice settings. Seventy-seven MDD outpatients were randomly assigned to the mirtazapine or predetermined SSRIs groups, and investigators arbitrarily selected sertraline or paroxetine. The primary outcome was the proportion of benzodiazepine users at weeks 6, 12, and 24 between the groups. We defined patients showing a ≥50 % reduction in Hamilton depression rating scale (HDRS) scores from baseline as responders. Blood samples were collected at baseline, weeks 6, 12, and 24. Sixty-five patients prescribed benzodiazepines from prescription day 1 were analyzed for the primary outcome. The percentage of benzodiazepine users was significantly lower in the mirtazapine than in the SSRIs group at weeks 6, 12, and 24 (21.4 vs. 81.8 %; 11.1 vs. 85.7 %, both P  depressive episodes may reduce benzodiazepine use in patients with MDD. Trial registration UMIN000004144. Registered 2nd September 2010. The date of enrolment of the first participant to the trial was 24th August 2010. This study was retrospectively registered 9 days after the first participant was enrolled.

  10. Subject-driven titration of biphasic insulin aspart 30 twice daily is non-inferior to investigator-driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open-label, parallel-group, multicenter trial.

    Science.gov (United States)

    Yang, Wenying; Zhu, Lvyun; Meng, Bangzhu; Liu, Yu; Wang, Wenhui; Ye, Shandong; Sun, Li; Miao, Heng; Guo, Lian; Wang, Zhanjian; Lv, Xiaofeng; Li, Quanmin; Ji, Qiuhe; Zhao, Weigang; Yang, Gangyi

    2016-01-01

    The present study was to compare the efficacy and safety of subject-driven and investigator-driven titration of biphasic insulin aspart 30 (BIAsp 30) twice daily (BID). In this 20-week, randomized, open-label, two-group parallel, multicenter trial, Chinese patients with type 2 diabetes inadequately controlled by premixed/self-mixed human insulin were randomized 1:1 to subject-driven or investigator-driven titration of BIAsp 30 BID, in combination with metformin and/or α-glucosidase inhibitors. Dose adjustment was decided by patients in the subject-driven group after training, and by investigators in the investigator-driven group. Eligible adults (n = 344) were randomized in the study. The estimated glycated hemoglobin (HbA1c) reduction was 14.5 mmol/mol (1.33%) in the subject-driven group and 14.3 mmol/mol (1.31%) in the investigator-driven group. Non-inferiority of subject-titration vs investigator-titration in reducing HbA1c was confirmed, with estimated treatment difference -0.26 mmol/mol (95% confidence interval -2.05, 1.53) (-0.02%, 95% confidence interval -0.19, 0.14). Fasting plasma glucose, postprandial glucose increment and self-measured plasma glucose were improved in both groups without statistically significant differences. One severe hypoglycemic event was experienced by one subject in each group. A similar rate of nocturnal hypoglycemia (events/patient-year) was reported in the subject-driven (1.10) and investigator-driven (1.32) groups. There were 64.5 and 58.1% patients achieving HbA1c titration of BIAsp 30 BID was as efficacious and well-tolerated as investigator-titration. The present study supported patients to self-titrate BIAsp 30 BID under physicians' supervision.

  11. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial.

    Science.gov (United States)

    Haak, Thomas; Hanaire, Hélène; Ajjan, Ramzi; Hermanns, Norbert; Riveline, Jean-Pierre; Rayman, Gerry

    2017-02-01

    Glycemic control in participants with insulin-treated diabetes remains challenging. We assessed safety and efficacy of new flash glucose-sensing technology to replace self-monitoring of blood glucose (SMBG). This open-label randomized controlled study (ClinicalTrials.gov, NCT02082184) enrolled adults with type 2 diabetes on intensive insulin therapy from 26 European diabetes centers. Following 2 weeks of blinded sensor wear, 2:1 (intervention/control) randomization (centrally, using biased-coin minimization dependant on study center and insulin administration) was to control (SMBG) or intervention (glucose-sensing technology). Participants and investigators were not masked to group allocation. Primary outcome was difference in HbA1c at 6 months in the full analysis set. Prespecified secondary outcomes included time in hypoglycemia, effect of age, and patient satisfaction. Participants (n = 224) were randomized (149 intervention, 75 controls). At 6 months, there was no difference in the change in HbA1c between intervention and controls: -3.1 ± 0.75 mmol/mol, [-0.29 ± 0.07% (mean ± SE)] and -3.4 ± 1.04 mmol/mol (-0.31 ± 0.09%) respectively; p = 0.8222. A difference was detected in participants aged glucose-sensing technology use in type 2 diabetes with intensive insulin therapy results in no difference in HbA1c change and reduced hypoglycemia, thus offering a safe, effective replacement for SMBG. ClinicalTrials.gov identifier: NCT02082184. Abbott Diabetes Care.

  12. AN OPEN-LABEL MULTICENTER OBSERVATIONAL STUDY OF THE EFFICACY, TOLERABILITY, AND SAFETY OF THE NONSTEROIDAL ANTI-INFLAMMATORY DRUG AMTOLMETIN GUACIL IN PATIENTS WITH KNEE OSTEOARTHRITIS AND DYSPEPSIA

    Directory of Open Access Journals (Sweden)

    E. S. Tsvetkova

    2016-01-01

    Full Text Available Objective: to investigate the efficacy and tolerability of amtolmetin guacil (AMG; Niselat®, Dr. Reddy's Laboratories Ltd, India versus previous therapy with nonsteroidal anti-inflammatory drugs (NSAIDs in patients with knee osteoarthritis (OA and signs of dyspepsia.Subjects and methods. The open-label observational study included 220 patients aged 30–65 years who suffered from knee OA and intense pain during NSAID intake and had symptoms of dyspepsia in the absence of contraindications to the use of AMG. Among the comorbidities that generally occurred in 68% of the patients, there was a preponderance of hypertension (42%, lower extremity varicose veins (6.4%, and diabetes mellitus (6%. Treatment efficacy was evaluated using three domains of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, by also taking into account pain intensity and general health assessment on the visual analogue scale. A Severity of Dyspepsia Assessment (SODA scale was used to rate dyspepsia.Results and discussion. AMG had a marked analgesic effect confirmed by 40% or more pain reduction that occurred in 72.5% of the patients. The high analgesic effect of AMG was confirmed by a statistically significant (p <0.001 reduction in the WOMAC index (pain and stiffness and by an increase in functional activity. There was a significant decrease in painless and painful signs of dyspepsia, as well as positive changes in the measures “overall assessment of dyspepsia severity” (p < 0.001 and “satisfaction with treatment”. Overall assessment of AMG tolerability was only positive: excellent (33%, good (56%, and satisfactory (11%. There were no serious adverse events (AE. AE were graded as moderate and mild in 8 and 82% of cases, respectively. AE were recorded in 7.7% of the patients. Conclusion. The findings suggest that AMG offers good prospects for knee OA treatment.

  13. A multicenter, open-label, pilot study evaluating the functionality of an integrated call center for a digital medicine system to optimize monitoring of adherence to oral aripiprazole in adult patients with serious mental illness

    Directory of Open Access Journals (Sweden)

    Kopelowicz A

    2017-10-01

    Full Text Available Alex Kopelowicz,1 Ross A Baker,2 Cathy Zhao,2 Claudette Brewer,3 Erica Lawson,3 Timothy Peters-Strickland2 1David Geffen School of Medicine, University of California, Los Angeles, CA, 2Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ, 3Otsuka Pharmaceutical Development and Commercialization Inc., Rockville, MD, USA Background: Medication nonadherence is common in the treatment of serious mental illness (SMI and leads to poor outcomes. The digital medicine system (DMS objectively measures adherence with oral aripiprazole in near-real time, allowing recognition of adherence issues. This pilot study evaluated the functionality of an integrated call center in optimizing the use of the DMS. Materials and methods: An 8-week, open-label, single-arm trial at four US sites enrolled adults with bipolar I disorder, major depressive disorder, and schizophrenia on stable oral aripiprazole doses and willing to use the DMS (oral aripiprazole + ingestible event marker [IEM], IEM-detecting skin patch, and software application. Integrated call-center functionality was assessed based on numbers and types of calls. Ingestion adherence with prescribed treatment (aripiprazole + IEM during good patch wear and proportion of time with good patch wear (days with ≥80% patch data or detected IEM were also assessed. Results: All enrolled patients (n=49 used the DMS and were included in analyses; disease duration overall approached 10 years. For a duration of 8 weeks, 136 calls were made by patients, and a comparable 160 calls were made to patients, demonstrating interactive communication. The mean (SD number of calls made by patients was 2.8 (3.5. Approximately half of the inbound calls made by patients occurred during the first 2 weeks and were software application- or patch-related. Mean ingestion adherence was 88.6%, and corresponding good patch wear occurred on 80.1% of study days. Conclusion: In this pilot study, the integrated call center

  14. Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: Results of a phase III, randomized, open-label, multicenter study.

    Science.gov (United States)

    Lal, Himal; Poder, Airi; Campora, Laura; Geeraerts, Brecht; Oostvogels, Lidia; Vanden Abeele, Carline; Heineman, Thomas C

    2018-01-02

    In phase III trials, 2 doses of a herpes zoster (HZ) subunit vaccine (HZ/su; 50 µg varicella-zoster virus glycoprotein E [gE] and AS01 B Adjuvant System) administered 2-months apart in older adults (≥50 and ≥70 years) demonstrated >90% efficacy in preventing HZ and had a clinically acceptable safety profile. Here we report immunogenicity, reactogenicity and safety following administration of 2 HZ/su doses at intervals longer than 2 months. In this Phase III, open-label trial conducted in the US and Estonia, 354 adults ≥50 years were randomized 1:1:1 to receive 2 HZ/su doses 2, 6, or 12 months apart. gE-specific humoral immune responses were evaluated at pre-vaccination, 1 and 12 months post-dose 2. Co-primary objectives were to compare immune responses to HZ/su 1 month post-dose 2 when given 6-months or 12-months apart to those administered 2-months apart. For each participant, safety information was collected from dose 1 to 12 months post-dose 2. 346 participants completed the study and 343 were included in the according-to-protocol cohort for immunogenicity. One month post-dose 2, vaccine response rates were 96.5% (97.5% confidence interval [CI]: 90.4; 99.2) and 94.5% (97.5% CI: 87.6; 98.3) for the 0, 6- and 0, 12-month schedules, respectively, both schedules meeting the pre-defined criterion. Non-inferiority of anti-gE geometric mean concentrations was demonstrated for HZ/su administered on 0, 6-month compared to a 0, 2-month schedule; however, HZ/su administered on a 0, 12-month schedule did not meet the non-inferiority criterion. Injection site pain was the most commonly reported solicited adverse event (AE). 26 participants each reported at least 1 serious AE; none were assessed as related to vaccination. Immune responses to HZ/su administered at 0, 6-month were non-inferior to those elicited by a 0, 2-month schedule. HZ/su exhibited a clinically acceptable safety profile for all dosing intervals. Clinicaltrials.gov (NCT01751165

  15. Comparison of latanoprost with fixed-combination dorzolamide and timolol in adult patients with elevated intraocular pressure: an eight-week, randomized, open-label, parallel-group, multicenter study in Latin America.

    Science.gov (United States)

    Susanna, Remo; Sussana, Remo; Sheu, Wang-Pui

    2004-05-01

    The newer ocular hypotensive agents available to treat glaucoma and ocular hypertension (OHT) include latanoprost, a prostaglandin F(2alpha) analogue, and the fixed combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor, and timolol maleate, a beta-blocker. The aim of this study was to compare the efficacy and tolerability of latanoprost with that of the fixed combination of dorzolamide and timolol over 8 weeks. This interventional, 8-week, randomized, open-label, parallel-group study was conducted at 18 centers in 6 Latin American countries. Patients with unilateral or bilateral primary open-angle, pigmentary, or exfoliative glaucoma or OHT were randomized to receive latanoprost, 1 drop in the affected eye QD (evening), or fixed-combination dorzolamide/timolol, 1 drop in the affected eye BID (morning and evening). Medications were self-administered, 1 drop per affected eye. At baseline and week 8, intraocular pressure (IOP) was measured 3 times each at 8:30 am, 10:00 am, 2:00 pm, and 5:00 pm and after the water-drinking test, which estimates the IOP peak of diurnal tension curve, performed following the 5:00 pm IOP assessment. The primary efficacy outcome was change in diurnal IOP (the mean of IOP measurements) from baseline to week 8. Adverse effect (AE) data were recorded at each visit. A total of 229 patients were randomized (latanoprost, n = 112; dorzolamide/timolol, n = 117). Mean baseline diurnal IOP values were similar between the 2 groups. Mean (SD) diurnal IOP reductions at week 8 before the water-drinking test were 6.9 (3.0) mm Hg for the latanoprost group and 6.4 (3.2) mm Hg for the dorzolamide/timolol group. Mean IOP values were similar at all time points except at 5:00 pm, when levels were significantly lower in latanoprost-treated patients (P = 0.025). After the water-drinking test, the increase in IOP values was similar between groups at baseline but lower in latanoprost-treated patients at week 8 (adjusted difference, 1.08 mm Hg

  16. SESOTHO trial ("Switch Either near Suppression Or THOusand") - switch to second-line versus WHO-guided standard of care for unsuppressed patients on first-line ART with viremia below 1000 copies/mL: protocol of a multicenter, parallel-group, open-label, randomized clinical trial in Lesotho, Southern Africa.

    Science.gov (United States)

    Amstutz, Alain; Nsakala, Bienvenu Lengo; Vanobberghen, Fiona; Muhairwe, Josephine; Glass, Tracy Renée; Achieng, Beatrice; Sepeka, Mamorena; Tlali, Katleho; Sao, Lebohang; Thin, Kyaw; Klimkait, Thomas; Battegay, Manuel; Labhardt, Niklaus Daniel

    2018-02-12

    The World Health Organization (WHO) recommends viral load (VL) measurement as the preferred monitoring strategy for HIV-infected individuals on antiretroviral therapy (ART) in resource-limited settings. The new WHO guidelines 2016 continue to define virologic failure as two consecutive VL ≥1000 copies/mL (at least 3 months apart) despite good adherence, triggering switch to second-line therapy. However, the threshold of 1000 copies/mL for defining virologic failure is based on low-quality evidence. Observational studies have shown that individuals with low-level viremia (measurable but below 1000 copies/mL) are at increased risk for accumulation of resistance mutations and subsequent virologic failure. The SESOTHO trial assesses a lower threshold for switch to second-line ART in patients with sustained unsuppressed VL. In this multicenter, parallel-group, open-label, randomized controlled trial conducted in Lesotho, patients on first-line ART with two consecutive unsuppressed VL measurements ≥100 copies/mL, where the second VL is between 100 and 999 copies/mL, will either be switched to second-line ART immediately (intervention group) or not be switched (standard of care, according to WHO guidelines). The primary endpoint is viral resuppression (VL < 50 copies/mL) 9 months after randomization. We will enrol 80 patients, giving us 90% power to detect a difference of 35% in viral resuppression between the groups (assuming two-sided 5% alpha error). For our primary analysis, we will use a modified intention-to-treat set, with those lost to care, death, or crossed over considered failure to resuppress, and using logistic regression models adjusted for the prespecified stratification variables. The SESOTHO trial challenges the current WHO guidelines, assessing an alternative, lower VL threshold for patients with unsuppressed VL on first-line ART. This trial will provide data to inform future WHO guidelines on VL thresholds to recommend switch to second-line ART

  17. Nutrition Labeling

    DEFF Research Database (Denmark)

    Grunert, Klaus G

    2013-01-01

    because consumers will avoid products that the label shows to be nutritionally deficient, but also because food producers will try to avoid marketing products that appear, according to the label, as nutritionally problematic, for example, because of a high content of saturated fat or salt. Nutrition......Nutrition labeling refers to the provision of information on a food product’s nutritional content on the package label. It can serve both public health and commercial purposes. From a public health perspective, the aim of nutrition labeling is to provide information that can enable consumers...... to make healthier choices when choosing food products. Nutrition labeling is thus closely linked to the notion of the informed consumer, that chooses products according to their aims, on the basis of the information at their disposal. Because many consumers are assumed to be interested in making healthy...

  18. Private Labels

    OpenAIRE

    Kolmačková, Zuzana

    2013-01-01

    This Bachelor Thesis titled Private labels deals with distribution strategy based on the introduction of private labels especially in retail chains. At the beginning it is focused on the general concept of private label offered by retailers, where is mentioned basic characteristics, history and structuring of distribution brands. Subsequently this thesis informs readers about the introduction of new special distribution brands, which focus primarily on the new consumption habits of customers....

  19. Sustainability Labeling

    NARCIS (Netherlands)

    Dam, van Y.K.

    2017-01-01

    Sustainability labeling originated from a need to protect the identity of alternative systems of food production and to increase market transparency. From the 1980s onwards sustainability labeling has changed into a policy instrument replacing direct government regulation of the food market, and a

  20. Pesticide Labels

    Science.gov (United States)

    Pesticide labels translate results of our extensive evaluations of pesticide products into conditions, directions and precautions that define parameters for use of a pesticide with the goal of ensuring protection of human health and the environment.

  1. Labelling patients

    International Nuclear Information System (INIS)

    Strudwick, R.M.

    2016-01-01

    This article looks at how diagnostic radiographers label their patients. An ethnographic study of the workplace culture in one diagnostic imaging department was undertaken using participant observation for four months and semi-structured interviews with ten key informants. One of the key themes; the way in which radiographers label their patients, is explored in this article. It was found from the study that within the department studied the diagnostic radiographers labelled or categorised their patients based on the information that they had. This information is used to form judgements and these judgements were used to assist the radiographers in dealing with the many different people that they encountered in their work. This categorisation and labelling of the patient appears to assist the radiographer in their decision-making processes about the examination to be carried out and the patient they are to image. This is an important aspect of the role of the diagnostic radiographer. - Highlights: • I have studied the culture in one imaging department. • Radiographers label or categorise their patients. • These labels/categories are used to manage the patient. • This is an important aspect of the way in which radiographers work.

  2. Food labels

    DEFF Research Database (Denmark)

    Selsøe Sørensen, Henrik; Clement, Jesper; Gabrielsen, Gorm

    2012-01-01

    evidence for dividing consumers into two profiles: one relying on general food knowledge and another using knowledge related to signpost labels. In a combined eyetracking and questionnaire survey we analyse the influence of background knowledge and identify different patterns of visual attention......The food industry develops tasty and healthy food but fails to deliver the message to all consumers. The consumers’ background knowledge is essential for how they find and decode relevant elements in the cocktail of signs which fight for attention on food labels. In this exploratory study, we find...... for the two consumer profiles. This underlines the complexity in choosing and designing the ‘right’ elements for a food package that consumers actually look at and are able to make rational use of. In spite of any regulation of food information provided by authorities, consumers will still be confronted...

  3. Label triangulation

    International Nuclear Information System (INIS)

    May, R.P.

    1983-01-01

    Label Triangulation (LT) with neutrons allows the investigation of the quaternary structure of biological multicomponent complexes under native conditions. Provided that the complex can be fully separated into and reconstituted from its single - protonated and deuterated - components, small angle neutron scattering (SANS) can give selective information on shapes and pair distances of these components. Following basic geometrical rules, the spatial arrangement of the components can be reconstructed from these data. LT has so far been successfully applied to the small and large ribosomal subunits and the transcriptase of E. coli. (author)

  4. A prospective, open-label, non-comparative study of palivizumab prophylaxis in children at high risk of serious respiratory syncytial virus disease in the Russian Federation

    Directory of Open Access Journals (Sweden)

    Turti Tatyana V

    2012-09-01

    Full Text Available Abstract Background Respiratory syncytial virus (RSV is a leading cause of lower respiratory tract infections (LRTIs in children globally. Predisposing conditions for the development of serious RSV disease include preterm infants and those with cardiopulmonary illness, including congenital heart disease (CHD and bronchopulmonary dysplasia (BPD. No vaccine is currently approved for the prevention of RSV infection. It is recommended that children at high risk be prophylactically administered palivizumab, a monoclonal antibody that has been shown in a number of clinical studies to reduce hospitalization rates due to serious RSV infection. The objective of the current study was to determine the safety and effectiveness of palivizumab in preventing serious RSV disease in high-risk children in the Russian Federation. Children at high risk of serious RSV disease (ie, born at ≤35 wk gestational age and ≤6 mo of age, and/or aged ≤24 mo with BPD or hemodynamically significant CHD were enrolled. Subjects were to receive 3 to 5 monthly injections of palivizumab 15 mg/kg (depending on the month of the initial injection over the RSV season. The primary endpoint was RSV-related hospitalizations. Adverse events (AEs were reported through 100 days following the final injection. Results One hundred subjects received ≥1 injection of palivizumab; 94 completed their dosing schedule. There were no RSV hospitalizations or deaths. Six of 7 subjects hospitalized for respiratory/cardiac conditions had an RSV test, which was negative in all cases. Three non-serious AEs (acute intermittent rhinitis and rhinitis, 1 subject; atopic dermatitis, 1 subject were considered possibly related to palivizumab. All other AEs were mild or moderate and considered not related/probably not related to palivizumab. Conclusion Palivizumab was generally well tolerated and effectively prevented serious RSV infection in a mixed population of high-risk children in the Russian Federation. Trial registration ClinicalTrials.gov: NCT01006629

  5. Euclidean supergravity and multi-centered solutions

    Directory of Open Access Journals (Sweden)

    W.A. Sabra

    2017-04-01

    Full Text Available In ungauged supergravity theories, the no-force condition for BPS states implies the existence of stable static multi-centered solutions. The first solutions to Einstein–Maxwell theory with a positive cosmological constant describing an arbitrary number of charged black holes were found by Kastor and Traschen. Generalisations to five and higher dimensional theories were obtained by London. Multi-centered solutions in gauged supergravity, even with time-dependence allowed, have yet to be constructed. In this letter we construct supersymmetry-preserving multi-centered solutions for the case of D=5, N=2 Euclidean gauged supergravity coupled to an arbitrary number of vector multiplets. Higher dimensional Einstein–Maxwell multi-centered solutions are also presented.

  6. Original Paper Multicenter study on antibiotic susceptibility ...

    African Journals Online (AJOL)

    Multicenter study on antibiotic susceptibility/resistance trends in the western region of Cameroon ... antibiotic era, IDs used to be serious threats because of lack or insufficient ...... antimicrobial use in livestock; AMR. Control., 116-122. Vandini ...

  7. Understanding Food Labels

    Science.gov (United States)

    ... Healthy eating for girls Understanding food labels Understanding food labels There is lots of info on food ... need to avoid because of food allergies. Other food label terms top In addition to the Nutrition ...

  8. Issues in Data Labelling

    NARCIS (Netherlands)

    Cowie, Roddy; Cox, Cate; Martin, Jeam-Claude; Batliner, Anton; Heylen, Dirk K.J.; Karpouzis, Kostas; Cowie, Roddy; Pelachaud, Catherine; Petta, Paolo

    2011-01-01

    Labelling emotion databases is not a purely technical matter. It is bound up with theoretical issues. Different issues affect labelling of emotional content, labelling of the signs that convey emotion, and labelling of the relevant context. Linked to these are representational issues, involving time

  9. Mixed Map Labeling

    Directory of Open Access Journals (Sweden)

    Maarten Löffler

    2016-12-01

    Full Text Available Point feature map labeling is a geometric visualization problem, in which a set of input points must be labeled with a set of disjoint rectangles (the bounding boxes of the label texts. It is predominantly motivated by label placement in maps but it also has other visualization applications. Typically, labeling models either use internal labels, which must touch their feature point, or external (boundary labels, which are placed outside the input image and which are connected to their feature points by crossing-free leader lines. In this paper we study polynomial-time algorithms for maximizing the number of internal labels in a mixed labeling model that combines internal and external labels. The model requires that all leaders are parallel to a given orientation θ ∈ [0, 2π, the value of which influences the geometric properties and hence the running times of our algorithms.

  10. Melphalan, prednisone, thalidomide and defibrotide in relapsed/refractory multiple myeloma: results of a multicenter phase I/II trial.

    Science.gov (United States)

    Palumbo, Antonio; Larocca, Alessandra; Genuardi, Mariella; Kotwica, Katarzyna; Gay, Francesca; Rossi, Davide; Benevolo, Giulia; Magarotto, Valeria; Cavallo, Federica; Bringhen, Sara; Rus, Cecilia; Masini, Luciano; Iacobelli, Massimo; Gaidano, Gianluca; Mitsiades, Constantine; Anderson, Kenneth; Boccadoro, Mario; Richardson, Paul

    2010-07-01

    Defibrotide is a novel orally bioavailable polydisperse oligonucleotide with anti-thrombotic and anti-adhesive effects. In SCID/NOD mice, defibrotide showed activity in human myeloma xenografts. This phase I/II study was conducted to identify the most appropriate dose of defibrotide in combination with melphalan, prednisone and thalidomide in patients with relapsed and relapsed/refractory multiple myeloma, and to determine its safety and tolerability as part of this regimen. This was a phase I/II, multicenter, dose-escalating, non-comparative, open label study. Oral melphalan was administered at a dose of 0.25 mg/kg on days 1-4, prednisone at a dose of 1.5 mg/kg also on days 1-4 and thalidomide at a dose of 50-100 mg/day continuously. Defibrotide was administered orally at three dose-levels: 2.4, 4.8 or 7.2 g on days 1-4 and 1.6, 3.2, or 4.8 g on days 5-35. Twenty-four patients with relapsed/refractory multiple myeloma were enrolled. No dose-limiting toxicity was observed. In all patients, the complete response plus very good partial response rate was 9%, and the partial response rate was 43%. The 1-year progression-free survival and 1-year overall survival rates were 34% and 90%, respectively. The most frequent grade 3-4 adverse events included neutropenia, thrombocytopenia, anemia and fatigue. Deep vein thrombosis was reported in only one patient. This combination of melphalan, prednisone and thalidomide together with defibrotide showed anti-tumor activity with a favorable tolerability. The maximum tolerated dose of defibrotide was identified as 7.2 g p.o. on days 1-4 followed by 4.8 g p.o. on days 5-35. Further trials are needed to confirm the role of this regimen and to evaluate the combination of defibrotide with new drugs.

  11. Succesful labelling schemes

    DEFF Research Database (Denmark)

    Juhl, Hans Jørn; Stacey, Julia

    2001-01-01

    . In the spring of 2001 MAPP carried out an extensive consumer study with special emphasis on the Nordic environmentally friendly label 'the swan'. The purpose was to find out how much consumers actually know and use various labelling schemes. 869 households were contacted and asked to fill in a questionnaire...... it into consideration when I go shopping. The respondent was asked to pick the most suitable answer, which described her use of each label. 29% - also called 'the labelling blind' - responded that they basically only knew the recycling label and the Government controlled organic label 'Ø-mærket'. Another segment of 6...

  12. Synthesizing labeled compounds

    International Nuclear Information System (INIS)

    London, R.E.; Matwiyoff, N.A.; Unkefer, C.J.; Walker, T.E.

    1983-01-01

    A metabolic study is presented of the chemical reactions provided by isotopic labeling and NMR spectroscopy. Synthesis of 13 C-labeled D-glucose, a 6-carbon sugar, involves adding a labeled nitrile group to the 5-carbon sugar D-arabinose by reaction with labeled hydrogen cyanide. The product of this reaction is then reduced and hydrolyzed to a mixture of the labeled sugars. The two sugars are separated by absorption chromotography. The synthesis of 13 C-labeled L-tyrosine, an amino acid, is also presented

  13. Electronic Submission of Labels

    Science.gov (United States)

    Pesticide registrants can provide draft and final labels to EPA electronically for our review as part of the pesticide registration process. The electronic submission of labels by registrants is voluntary but strongly encouraged.

  14. Robust Active Label Correction

    DEFF Research Database (Denmark)

    Kremer, Jan; Sha, Fei; Igel, Christian

    2018-01-01

    for the noisy data lead to different active label correction algorithms. If loss functions consider the label noise rates, these rates are estimated during learning, where importance weighting compensates for the sampling bias. We show empirically that viewing the true label as a latent variable and computing......Active label correction addresses the problem of learning from input data for which noisy labels are available (e.g., from imprecise measurements or crowd-sourcing) and each true label can be obtained at a significant cost (e.g., through additional measurements or human experts). To minimize......). To select labels for correction, we adopt the active learning strategy of maximizing the expected model change. We consider the change in regularized empirical risk functionals that use different pointwise loss functions for patterns with noisy and true labels, respectively. Different loss functions...

  15. Pesticide Product Label System

    Data.gov (United States)

    U.S. Environmental Protection Agency — The Pesticide Product Label System (PPLS) provides a collection of pesticide product labels (Adobe PDF format) that have been approved by EPA under Section 3 of the...

  16. Semiotic labelled deductive systems

    Energy Technology Data Exchange (ETDEWEB)

    Nossum, R.T. [Imperial College of Science, Technology and Medicine, London (United Kingdom)

    1996-12-31

    We review the class of Semiotic Models put forward by Pospelov, as well as the Labelled Deductive Systems developed by Gabbay, and construct an embedding of Semiotic Models into Labelled Deductive Systems.

  17. Mental Labels and Tattoos

    Science.gov (United States)

    Hyatt, I. Ralph

    1977-01-01

    Discusses the ease with which mental labels become imprinted in our system, six basic axioms for maintaining negative mental tattoos, and psychological processes for eliminating mental tattoos and labels. (RK)

  18. Soil Fumigant Labels - Dazomet

    Science.gov (United States)

    Updated labels include new safety requirements for buffer zones and related measures. Find information from the Pesticide Product Labeling System (PPLS) for products such as Basamid G, manufactured by Amvac.

  19. Soil Fumigant Labels - Chloropicrin

    Science.gov (United States)

    Search by EPA registration number, product name, or company name, and follow the link to the Pesticide Product Label System (PPLS) for details on each fumigant. Updated labels include new safety requirements for buffer zones and related measures.

  20. A Label to Regulate

    DEFF Research Database (Denmark)

    Tricoire, Aurélie; Boxenbaum, Eva; Laurent, Brice

    This paper examines the role labelling plays in the government of the contemporary economy.1Drawing on a detailed study of BBC-Effinergy, a French label for sustainable construction, we showhow the adoption and evolution of voluntary labels can be seen as emblematic of a governmentthrough experim...

  1. Labelling subway lines

    NARCIS (Netherlands)

    Garrido, M.A.; Iturriaga, C.; Márquez, A.; Portillo, J.R.; Reyes, P.; Wolff, A.; Eades, P.; Takaoka, T.

    2001-01-01

    Graphical features on map, charts, diagrams and graph drawings usually must be annotated with text labels in order to convey their meaning. In this paper we focus on a problem that arises when labeling schematized maps, e.g. for subway networks. We present algorithms for labeling points on a line

  2. Label Review Training: Module 1: Label Basics, Page 15

    Science.gov (United States)

    This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about the consequences of improper labeling.

  3. Label Review Training: Module 1: Label Basics, Page 23

    Science.gov (United States)

    This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Lists types of labels that do not require review.

  4. Label Review Training: Module 1: Label Basics, Page 16

    Science.gov (United States)

    This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about the importance of labels and the role in enforcement.

  5. Label Review Training: Module 1: Label Basics, Page 14

    Science.gov (United States)

    This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about positive effects from proper labeling.

  6. Label Review Training: Module 1: Label Basics, Page 21

    Science.gov (United States)

    This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about types of labels.

  7. Label Review Training: Module 1: Label Basics, Page 22

    Science.gov (United States)

    This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about what labels require review.

  8. Label Review Training: Module 1: Label Basics, Page 18

    Science.gov (United States)

    This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. This section discusses the types of labels.

  9. Label Review Training: Module 1: Label Basics, Page 26

    Science.gov (United States)

    This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about mandatory and advisory label statements.

  10. Label Review Training: Module 1: Label Basics, Page 24

    Science.gov (United States)

    This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. This page is about which labels require review.

  11. Label Review Training: Module 1: Label Basics, Page 27

    Science.gov (United States)

    This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. See examples of mandatory and advisory label statements.

  12. Label Review Training: Module 1: Label Basics, Page 19

    Science.gov (United States)

    This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. This section covers supplemental distributor labeling.

  13. Label Review Training: Module 1: Label Basics, Page 17

    Science.gov (United States)

    This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. See an overview of the importance of labels.

  14. A multicenter, primary-care-based, open-label study to assess the success of converting opioid-experienced patients with chronic moderate-to-severe pain to morphine sulfate and naltrexone hydrochloride extended-release capsules using a standardized conversion guide.

    Science.gov (United States)

    Setnik, Beatrice; Roland, Carl L; Sommerville, Kenneth W; Pixton, Glenn C; Berke, Robert; Calkins, Anne; Goli, Veeraindar

    2015-01-01

    To evaluate the conversion of opioid-experienced patients with chronic moderate-to-severe pain to extended-release morphine sulfate with sequestered naltrexone hydrochloride (MSN) using a standardized conversion guide. This open-label, single-arm study was conducted in 157 primary care centers in the United States. A total of 684 opioid-experienced adults with chronic moderate-to-severe pain were converted to oral administration of MSN from transdermal fentanyl and oral formulations of hydrocodone, hydromorphone, methadone, oxycodone, oxymorphone, and other morphine products using a standardized conversion guide. The primary endpoint was the percentage of patients achieving a stable MSN dose within a 6-week titration phase. Secondary endpoints included duration of time to stable dose, number of titration steps, safety and efficacy measures, and investigator assessment of conversion guide utility. Of the 684 patients, 51.3% were converted to a stable dose of MSN (95% confidence interval: 47.5%, 55.1%). The mean (standard deviation) number of days to stable dose was 20 (8.94), and number of titration steps to stable dose was 2.4 (1.37). The majority of adverse events were mild/moderate and consistent with opioid therapy. Mean pain scores at stable dose decreased from baseline. Investigators were generally satisfied with the conversion guide and, in 94% of cases, reported they would use it again. Conversion to MSN treatment using the standardized MSN conversion guide was an attainable goal in approximately half of the population of opioid-experienced patients with chronic moderate-to-severe pain. Investigators found the guide to be a useful tool to assist conversion of opioid-experienced patients to MSN.

  15. Elliptic genera from multi-centers

    Energy Technology Data Exchange (ETDEWEB)

    Gaddam, Nava [Institute for Theoretical Physics and Center for Extreme Matter and Emergent Phenomena,Utrecht University, 3508 TD Utrecht (Netherlands)

    2016-05-13

    I show how elliptic genera for various Calabi-Yau threefolds may be understood from supergravity localization using the quantization of the phase space of certain multi-center configurations. I present a simple procedure that allows for the enumeration of all multi-center configurations contributing to the polar sector of the elliptic genera — explicitly verifying this in the cases of the quintic in ℙ{sup 4}, the sextic in Wℙ{sub (2,1,1,1,1)}, the octic in Wℙ{sub (4,1,1,1,1)} and the dectic in Wℙ{sub (5,2,1,1,1)}. With an input of the corresponding ‘single-center’ indices (Donaldson-Thomas invariants), the polar terms have been known to determine the elliptic genera completely. I argue that this multi-center approach to the low-lying spectrum of the elliptic genera is a stepping stone towards an understanding of the exact microscopic states that contribute to supersymmetric single center black hole entropy in N=2 supergravity.

  16. A multicenter, primary-care-based, open-label study to assess the success of converting opioid-experienced patients with chronic moderate-to-severe pain to morphine sulfate and naltrexone hydrochloride extended-release capsules using a standardized conversion guide

    Directory of Open Access Journals (Sweden)

    Setnik B

    2015-07-01

    Full Text Available Beatrice Setnik,1 Carl L Roland,1 Kenneth W Sommerville,1,2 Glenn C Pixton,1 Robert Berke,3,4 Anne Calkins,5 Veeraindar Goli1,2 1Pfizer Inc, 2Duke University Medical Center, Durham, NC, USA; 3Family Health Medical Services PLLC, Mayville, 4Department of Social and Preventive Medicine, State University of New York at Buffalo, Buffalo, 5New York Spine & Wellness Center, Syracuse, NY, USA Objective: To evaluate the conversion of opioid-experienced patients with chronic moderate-to-severe pain to extended-release morphine sulfate with sequestered naltrexone hydrochloride (MSN using a standardized conversion guide. Methods: This open-label, single-arm study was conducted in 157 primary care centers in the United States. A total of 684 opioid-experienced adults with chronic moderate-to-severe pain were converted to oral administration of MSN from transdermal fentanyl and oral formulations of hydrocodone, hydromorphone, methadone, oxycodone, oxymorphone, and other morphine products using a standardized conversion guide. The primary endpoint was the percentage of patients achieving a stable MSN dose within a 6-week titration phase. Secondary endpoints included duration of time to stable dose, number of titration steps, safety and efficacy measures, and investigator assessment of conversion guide utility. Results: Of the 684 patients, 51.3% were converted to a stable dose of MSN (95% confidence interval: 47.5%, 55.1%. The mean (standard deviation number of days to stable dose was 20 (8.94, and number of titration steps to stable dose was 2.4 (1.37. The majority of adverse events were mild/moderate and consistent with opioid therapy. Mean pain scores at stable dose decreased from baseline. Investigators were generally satisfied with the conversion guide and, in 94% of cases, reported they would use it again. Conclusion: Conversion to MSN treatment using the standardized MSN conversion guide was an attainable goal in approximately half of the population of

  17. Labelling of equipment dispensers.

    Science.gov (United States)

    Gray, D C

    1993-01-01

    A new labelling system for use on medical equipment dispensers is tested. This system uses one of the objects stored in each unit of the dispenser as the 'label', by attaching it to the front of the dispenser with tape. The new system was compared to conventional written labelling by timing subjects asked to select items from two dispensers. The new system was 27% quicker than the conventional system. Images Fig. 1 PMID:8110335

  18. Deuterium labeled cannabinoids

    International Nuclear Information System (INIS)

    Driessen, R.A.

    1979-01-01

    Complex reactions involving ring opening, ring closure and rearrangements hamper complete understanding of the fragmentation processes in the mass spectrometric fragmentation patterns of cannabinoids. Specifically labelled compounds are very powerful tools for obtaining more insight into fragmentation mechanisms and ion structures and therefore the synthesis of specifically deuterated cannabinoids was undertaken. For this, it was necessary to investigate the preparation of cannabinoids, appropriately functionalized for specific introduction of deuterium atom labels. The results of mass spectrometry with these labelled cannabinoids are described. (Auth.)

  19. Effective sample labeling

    International Nuclear Information System (INIS)

    Rieger, J.T.; Bryce, R.W.

    1990-01-01

    Ground-water samples collected for hazardous-waste and radiological monitoring have come under strict regulatory and quality assurance requirements as a result of laws such as the Resource Conservation and Recovery Act. To comply with these laws, the labeling system used to identify environmental samples had to be upgraded to ensure proper handling and to protect collection personnel from exposure to sample contaminants and sample preservatives. The sample label now used as the Pacific Northwest Laboratory is a complete sample document. In the event other paperwork on a labeled sample were lost, the necessary information could be found on the label

  20. Dynamic map labeling.

    Science.gov (United States)

    Been, Ken; Daiches, Eli; Yap, Chee

    2006-01-01

    We address the problem of filtering, selecting and placing labels on a dynamic map, which is characterized by continuous zooming and panning capabilities. This consists of two interrelated issues. The first is to avoid label popping and other artifacts that cause confusion and interrupt navigation, and the second is to label at interactive speed. In most formulations the static map labeling problem is NP-hard, and a fast approximation might have O(nlogn) complexity. Even this is too slow during interaction, when the number of labels shown can be several orders of magnitude less than the number in the map. In this paper we introduce a set of desiderata for "consistent" dynamic map labeling, which has qualities desirable for navigation. We develop a new framework for dynamic labeling that achieves the desiderata and allows for fast interactive display by moving all of the selection and placement decisions into the preprocessing phase. This framework is general enough to accommodate a variety of selection and placement algorithms. It does not appear possible to achieve our desiderata using previous frameworks. Prior to this paper, there were no formal models of dynamic maps or of dynamic labels; our paper introduces both. We formulate a general optimization problem for dynamic map labeling and give a solution to a simple version of the problem. The simple version is based on label priorities and a versatile and intuitive class of dynamic label placements we call "invariant point placements". Despite these restrictions, our approach gives a useful and practical solution. Our implementation is incorporated into the G-Vis system which is a full-detail dynamic map of the continental USA. This demo is available through any browser.

  1. Stable isotopes labelled compounds

    International Nuclear Information System (INIS)

    1982-09-01

    The catalogue on stable isotopes labelled compounds offers deuterium, nitrogen-15, and multiply labelled compounds. It includes: (1) conditions of sale and delivery, (2) the application of stable isotopes, (3) technical information, (4) product specifications, and (5) the complete delivery programme

  2. Edge colouring by total labellings

    DEFF Research Database (Denmark)

    Brandt, Stephan; Rautenbach, D.; Stiebitz, M.

    2010-01-01

    We introduce the concept of an edge-colouring total k-labelling. This is a labelling of the vertices and the edges of a graph G with labels 1, 2, ..., k such that the weights of the edges define a proper edge colouring of G. Here the weight of an edge is the sum of its label and the labels of its...

  3. Radioiodine and its labelled compounds

    International Nuclear Information System (INIS)

    Robles, Ana Maria

    1994-01-01

    Chemical characteristics and their nuclear characteristics, types of labelled molecules,labelling procedures, direct labelling with various oxidizing agents, indirect labelling with various conjugates attached to protein molecules, purification and quality control. Iodination damage.Safe handling of labelling procedures with iodine radioisotopes.Bibliography

  4. 'Naturemade' -- a new label

    International Nuclear Information System (INIS)

    Niederhaeusern, A.

    2001-01-01

    This short article discusses the introduction of the 'Naturemade' two-level labelling scheme in the Swiss electricity market, which is to help provide transparency in the market for green power and promote the building of facilities for its production. In the form of an interview with the CEO of Swissolar and the president of Greenpeace Switzerland, the pros and contras of these labels are discussed. In particular, the interview partners' opinions on the possible misuse of the less stringent label and the influence of the labels on the construction of new installations for the generation of electricity from renewable sources are presented. The basic principles of the promotional model behind the labels are listed

  5. Label Review Training: Module 1: Label Basics, Page 25

    Science.gov (United States)

    This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review: clarity, accuracy, consistency with EPA policy, and enforceability.

  6. Label Review Training: Module 1: Label Basics, Page 29

    Science.gov (United States)

    This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. This page is a quiz on Module 1.

  7. Coordination of international multicenter studies: governance and administrative structure

    Directory of Open Access Journals (Sweden)

    Bangdiwala Shrikant I.

    2003-01-01

    Full Text Available A well-conducted multicenter study needs to assure standardization, uniformity of procedures, high data quality, and collaboration across sites. This manuscript describes the organization and dynamics of multicenter studies, focusing on governance and administrative structures among countries of diverse cultures. The organizational structure of a multicenter study is described, and a system for oversight and coordination, along with roles and responsibilities of participants in the multicenter study, are presented. The elements of a governance document are also reviewed, along with guidelines and policies for effective collaboration. The experience of an ongoing multi-country collaboration, the World Studies of Abuse in the Family Environment (WorldSAFE, illustrates the implementation of these guidelines. It is essential that multicenter studies have an objective coordinating center and that the investigators jointly develop a written governance document to enable collaboration and preserve collegiality among participating investigators.

  8. Soil Fumigant Labels - Methyl Bromide

    Science.gov (United States)

    Search soil fumigant pesticide labels by EPA registration number, product name, or company, and follow the link to The Pesticide Product Label System (PPLS) for details. Updated labels include new safety requirements for buffer zones and related measures.

  9. Radioactive labelled orgotein

    International Nuclear Information System (INIS)

    1980-01-01

    The preparation and use of radioactively labelled orgotein, i.e. water-soluble protein congeners in pure, injectable form, is described. This radiopharmaceutical is useful in scintigraphy, especially for visualization of the kidneys where the orgotein is rapidly concentrated. Details of the processes for labelling bovine orgotein with sup(99m)Tc, 60 Co, 125 I or 131 I are specified. The pharmaceutical preparation of the labelled orgotein for intravenous and parenteral administration is also described. Examples using either sup(99m)TC or 125 I-orgotein in scintiscanning dogs' kidneys are given. (UK)

  10. On Online Labeling with Polynomially Many Labels

    DEFF Research Database (Denmark)

    Babka, Martin; Bulánek, Jan; Cunat, Vladimír

    2012-01-01

    be necessary to change the labels of some items; such changes may be done at any time at unit cost for each change. The goal is to minimize the total cost. An alternative formulation of this problem is the file maintenance problem, in which the items, instead of being labeled, are maintained in sorted order...... in an array of length m, and we pay unit cost for moving an item. For the case m = cn for constant c > 1, there are known algorithms that use at most O(n log(n)2) relabelings in total [9], and it was shown recently that this is asymptotically optimal [1]. For the case of m = θ(nC) for C > 1, algorithms...

  11. Clinical applications of cells labelling

    International Nuclear Information System (INIS)

    Gonzalez, B.M.

    1994-01-01

    Blood cells labelled with radionuclides are reviewed and main applications are described. Red blood cell labelling by both random and specific principle. A table with most important clinical uses, 99mTc labelling of RBC are described pre tinning and in vivo reduction of Tc, in vitro labelling and administration of labelled RBC and in vivo modified technique. Labelled leucocytes with several 99mTc-complex radiopharmaceuticals by in vitro technique and specific monoclonal s for white cells(neutrofiles). Labelled platelets for clinical use and research by in vitro technique and in vivo labelling

  12. FDA Online Label Repository

    Data.gov (United States)

    U.S. Department of Health & Human Services — The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug...

  13. Figuring Out Food Labels

    Science.gov (United States)

    ... It's also displayed in grocery stores near fresh foods, like fruits, vegetables, and fish. The nutrition facts label includes: a ... found in citrus fruits, other fruits, and some vegetables. Food companies might also list the amounts of other ...

  14. Energy efficiency labelling

    Energy Technology Data Exchange (ETDEWEB)

    1978-04-01

    This research assesses the likely effects on UK consumers of the proposed EEC energy-efficiency labeling scheme. Unless (or until) an energy-labeling scheme is introduced, it is impossible to do more than postulate its likely effects on consumer behavior. This report shows that there are indeed significant differences in energy consumption between different brands and models of the same appliance of which consumers are unaware. Further, the report suggests that, if a readily intelligible energy-labeling scheme were introduced, it would provide useful information that consumers currently lack; and that, if this information were successfully presented, it would be used and could have substantial effects in reducing domestic fuel consumption. Therefore, it is recommended that an energy labeling scheme be introduced.

  15. Like your labels?

    Science.gov (United States)

    Field, Michele

    2010-01-01

    The descriptive “conventions” used on food labels are always evolving. Today, however, the changes are so complicated (partly driven by legislation requiring disclosures about environmental impacts, health issues, and geographical provenance) that these labels more often baffle buyers than enlighten them. In a light-handed manner, the article points to how sometimes reading label language can be like deciphering runes—and how if we are familiar with the technical terms, we can find a literal meaning, but still not see the implications. The article could be ten times longer because food labels vary according to cultures—but all food-exporting cultures now take advantage of our short attention-span when faced with these texts. The question is whether less is more—and if so, in this contest for our attention, what “contestant” is voted off.

  16. Multi-center MRI carotid plaque component segmentation using feature normalization and transfer learning

    DEFF Research Database (Denmark)

    van Engelen, Arna; van Dijk, Anouk C; Truijman, Martine T.B.

    2015-01-01

    implementation of supervised methods. In this paper we segment carotid plaque components of clinical interest (fibrous tissue, lipid tissue, calcification and intraplaque hemorrhage) in a multicenter MRI study. We perform voxelwise tissue classification by traditional same-center training, and compare results...... not yield significant differences from that reference. We conclude that both extensive feature normalization and transfer learning can be valuable for the development of supervised methods that perform well on different types of datasets.......Automated segmentation of plaque components in carotid artery MRI is important to enable large studies on plaque vulnerability, and for incorporating plaque composition as an imaging biomarker in clinical practice. Especially supervised classification techniques, which learn from labeled examples...

  17. Labelling of electricity

    International Nuclear Information System (INIS)

    Dettli, R.; Markard, J.

    2001-01-01

    This comprehensive report for the Swiss Federal Office of Energy (SFOE) presents a possible course of action to be taken to provide a means of declaring the sources of electrical power, as is foreseen in the draft of new Swiss electricity market legislation. The report presents the basic ideas behind the idea and defines the terms used such as labelling, certificates and declarations. Also, the legal situation in the European Union and in Switzerland is examined and a quantitative overview of electricity production and consumption is presented. Suggestions for a labelling scheme are made and some of the problems to be expected are looked at. The report also presents a series of examples of labelling schemes already implemented in other countries, such as Austria, Great Britain, Sweden and Germany. Tradable certificates and tracking systems are discussed as are initial quality labels like the Swiss 'Naturemade' label for green power. A concrete recommendation for the declaration and labelling of electricity in Switzerland is presented and various factors to be considered such as import/export, pumped storage, distribution losses, small-scale producers as well as the time-scales for introduction are discussed

  18. 78 FR 66826 - Prior Label Approval System: Generic Label Approval

    Science.gov (United States)

    2013-11-07

    ... raising of animals, such as ``no antibiotics administered'' or ``vegetarian fed''; (4) instructional or... Standards and Labeling Policy Book includes animal production claims; omega fatty acid guidance; allergen... inclusion of Country of Origin Labeling on all labels; the production and sale of labels by USDA; developing...

  19. European consumers and nutrition labelling

    DEFF Research Database (Denmark)

    Wills, Josephine M.; Grunert, Klaus G.; Celemín, Laura Fernández

    2009-01-01

    Nutrition labelling of food in Europe is not compulsory, unless a nutrition or health claim is made for the product. The European Commission is proposing mandatory nutrition labelling, even front of pack labelling with nutrition information. Yet, how widespread is nutrition labelling in the EU...

  20. Genetic algorithms for map labeling

    NARCIS (Netherlands)

    Dijk, Steven Ferdinand van

    2001-01-01

    Map labeling is the cartographic problem of placing the names of features (for example cities or rivers) on the map. A good labeling has no intersections between labels. Even basic versions of the problem are NP-hard. In addition, realistic map-labeling problems deal with many cartographic

  1. Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema

    DEFF Research Database (Denmark)

    Aberer, W; Maurer, M; Reshef, A

    2014-01-01

    Historically, treatment for hereditary angioedema (HAE) attacks has been administered by healthcare professionals (HCPs). Patient self-administration could reduce delays between symptom onset and treatment, and attack burden. The primary objective was to assess the safety of self-administered ica...

  2. Adjunctive corticosteroid therapy for Pneumocystis carinii pneumonia in AIDS: a randomized European multicenter open label study

    DEFF Research Database (Denmark)

    Nielsen, T L; Eeftinck Schattenkerk, J K; Jensen, B N

    1992-01-01

    .0 kPa (67.5 mm Hg) and/or a PaCO2 less than 4.0 kPa (30.0 mm Hg) while breathing room air. During the acute episode of PCP, 9 (31%) of the 29 control patients died versus 3 (10%) of the 30 CS patients; p = 0.01. Mechanical ventilation was necessary in 15 patients; 12 (41%) in the control group and 3...

  3. A multicenter study on Leigh syndrome

    DEFF Research Database (Denmark)

    Sofou, Kalliopi; De Coo, Irenaeus F M; Isohanni, Pirjo

    2014-01-01

    BACKGROUND: Leigh syndrome is a progressive neurodegenerative disorder, associated with primary or secondary dysfunction of the mitochondrial oxidative phosphorylation. Despite the fact that Leigh syndrome is the most common phenotype of mitochondrial disorders in children, longitudinal natural...... history data is missing. This study was undertaken to assess the phenotypic and genotypic spectrum of patients with Leigh syndrome, characterise the clinical course and identify predictors of survival in a large cohort of patients. METHODS: This is a retrospective study of patients with Leigh syndrome...... to thrive, brainstem lesions on neuroimaging and intensive care treatment were significantly associated with poorer survival. CONCLUSIONS: This is a multicenter study performed in a large cohort of patients with Leigh syndrome. Our data help define the natural history of Leigh syndrome and identify novel...

  4. Radioactive labelling of peptidic hormones

    International Nuclear Information System (INIS)

    Fromageot, P.; Pradelles, P.; Morgat, J.L.; Levine, H.

    1976-01-01

    The labelling of peptidic hormones requires stability, specificity and sensitivity of the label. Introduction of a radioactive atome is one way to satisfy these criteria. Several processes have been described to prepare radioactive TRF: synthesis of the peptide with labelled aminoacids or introduction of the label into the hormone. In that approach, tritium can be substituted in the imidazole ring, via precursors activating the proper carbon. Monoiodo TRF leads essentially to tritium labelling of the 5 positions whereas monoazo TRF allows the preparation of 3 H TRF labelled in the 2 positions. Di-substituted TRF leads to labelling into the 2 and 5 carbons. Labelled analogs of TRF can be prepared with labelled iodine; further developments of peptide labelling, will be presented. In particular, the homolytic scission of the C-iodine, bond by photochemical activation. The nascent carbon radical can be stabilized by a tritiated scavenger. This approach eliminates the use of heavy metal catalysts

  5. Radiopharmaceutical labeling research

    International Nuclear Information System (INIS)

    Anon.

    1985-01-01

    The objective of this research is to develop methods of attaching radionuclides to monoclonal antibodies and antibody fragments for use in tumor imaging and internal radiation therapy. Monoclonal antibodies and their fragments are of interest because they enable the selective targeting of tumors. The labeled antibodies could be employed as carriers to transport radioisotopes to tumors, thus minimizing total-body radiation dose and radiation damage to normal tissue. Because the time required for labeled antibodies to find the tumor antigen and deliver the dose to the tumor is estimated to be about 1-3 days, radionuclides with a l- to 3-day half-life would be optimum for this purpose. Two of the radionuclides produced at LAMPF, 67 Cu and 77 Br, have the suitable half-life and nuclear-decay properties for use in tumor imaging or therapy with radiolabeled antibodies. These radionuclides and the efforts to prepare radiolabeled antibodies with them are described. We have used three different approaches to meet this objective of labeling antibodies: (1) labeling chelating agents with metal radionuclides, then conjugating the labeled chelating agents to antibodies; (2) conjugating activated chelating agents to antibodies, followed by metalation with metal radionuclides; and (3) radiobrominating small molecules that can be conjugated to antibodies

  6. Fluorine-18 labelled compounds

    International Nuclear Information System (INIS)

    Kleijn, J.P. de

    1978-01-01

    The work presented in this thesis deals with the problems involved in the adaption of reactor-produced fluorine-18 to the synthesis of 18 F-labelled organic fluorine compounds. Several 18 F-labelling reagents were prepared and successfully applied. The limitations to the synthetic possibilities of reactor-produced fluoride- 18 become manifest in the last part of the thesis. An application to the synthesis of labelled aliphatic fluoro amino acids has appeared to be unsuccessful as yet, although some other synthetic approaches can be indicated. Seven journal articles (for which see the availability note) are used to compose the four chapters and three appendices. The connecting text gives a survey of known 18 F-compounds and methods for preparing such compounds. (Auth.)

  7. Synthesis of labeled compounds

    International Nuclear Information System (INIS)

    Whaley, T.W.

    1977-01-01

    Intermediate compounds labeled with 13 C included methane, sodium cyanide, methanol, ethanol, and acetonitrile. A new method for synthesizing 15 N-labeled 4-ethylsulfonyl-1-naphthalene-sulfonamide was developed. Studies were conducted on pathways to oleic-1- 13 C acid and a second pathway investigated was based on carbonation of 8-heptadecynylmagnesium bromide with CO 2 to prepare sterolic acid. Biosynthetic preparations included glucose- 13 C from starch isolated from tobacco leaves following photosynthetic incubation with 13 CO 2 and galactose- 13 C from galactosylglycerol- 13 C from kelp. Research on growth of organisms emphasized photosynthetic growth of algae in which all cellular carbon is labeled. Preliminary experiments were performed to optimize the growth of Escherichia coli on sodium acetate- 13 C

  8. Environmental Labels and Declarations

    DEFF Research Database (Denmark)

    Frydendal, Jeppe; Hansen, Lisbeth; Bonou, Alexandra

    2018-01-01

    Based on the terminology and structure developed by the International Organization for Standardization, a description is given on the types of ecolabels that build on life cycle assessments. Focus is on type I labels that point out products and services with an overall environmental preferability...... of labelling, the use of ecolabels in marketing, and the way ecolabels help build a market for “greener products”. Type III labels—or Environmental Product Declarations—are also briefly described with indicative examples from the building sector, a declaration for office furniture, and an introduction is given...... to the European Commission’s programme for product—and organisational environmental footprints ....

  9. Semantic Role Labeling

    CERN Document Server

    Palmer, Martha; Xue, Nianwen

    2011-01-01

    This book is aimed at providing an overview of several aspects of semantic role labeling. Chapter 1 begins with linguistic background on the definition of semantic roles and the controversies surrounding them. Chapter 2 describes how the theories have led to structured lexicons such as FrameNet, VerbNet and the PropBank Frame Files that in turn provide the basis for large scale semantic annotation of corpora. This data has facilitated the development of automatic semantic role labeling systems based on supervised machine learning techniques. Chapter 3 presents the general principles of applyin

  10. Competing Environmental Labels

    NARCIS (Netherlands)

    Fischer, Carolyn; Lyon, Thomas P.

    2014-01-01

    We study markets in which consumers prefer green products but cannot determine the environmental quality of any given firm's product on their own. A nongovernmental organization (NGO) can establish a voluntary standard and label products that comply with it. Alternatively, industry can create its

  11. The Language of Labels

    Science.gov (United States)

    Markham, Darcy

    2005-01-01

    The author describes how the language of labels and her own cultural biases affect how she approaches teaching her students with disabilities. The author examines how the mythopoetic narratives of our past force us to examine the underlying assumptions of our culture that are expressed within our language and how understanding our own linguistic…

  12. Labeling of Cosmetic Products

    Directory of Open Access Journals (Sweden)

    Nicola Lionetti

    2018-03-01

    Full Text Available The labeling of cosmetic products provides a set of obligations, as reported in the Regulation 1223/2009, which came into force in Europe in July 2013. The indications reported on the label are intended to enable the clear identification of the functionality and proper use of cosmetics, ensure the protection of the consumer from the commercial aspects and, above all, from the safety point of view. Moreover, it should allow quick tracing of the product details and all info of toxicological relevance. However, the misuse of this tool often leads, on one side, to confusion among cosmetics, pharmaceuticals, medical devices, and biocides. On the other side, it gives rise to fanciful interpretations by a huge number of web users, who pretend to be able to judge the quality of a cosmetic product just by reading the ingredients list. This article points out the concrete purpose of cosmetic labels, in order to shed light on the use of certain categories of ‘controversial’ ingredients and on the real quality concepts of cosmetic products. Indeed, when properly interpreted, cosmetic labels represent a good tool for the professional investigation of adverse reactions to cosmetics.

  13. Label Review Training: Module 1: Label Basics, Page 7

    Science.gov (United States)

    Page 7, Label Training, Pesticide labels translate results of our extensive evaluations of pesticide products into conditions, directions and precautions that define parameters for use of a pesticide with the goal of ensuring protection of human he

  14. Acute necrotizing pancreatitis: a multicenter study.

    Science.gov (United States)

    Fernández-Cruz, L; Navarro, S; Valderrama, R; Sáenz, A; Guarner, L; Aparisi, L; Espi, A; Jaurietta, E; Marruecos, L; Gener, J

    1994-04-01

    A multicenter study of acute necrotizing pancreatitis (ANP) classified in accordance with the Balthazar criteria (grades D and E), has been performed in 12 teaching hospitals. A total of 233 patients were reviewed, and the mortality rate was 26.6%. The most common etiology was biliary pancreatitis (45.5%). Among the complications, shock, renal insufficiency, pulmonary insufficiency and hemorrhagic gastritis were associated with a mortality rate of 51-66%. Diffuse fluid collections were associated with a higher mortality rate (26.8%) than localized fluid collections (14.5%). In 106 patients with gallstone pancreatitis, early surgery was performed in 17, and 5 patients (29.4%) died. No mortality was observed in 32 patients with delayed surgery. Sphincterotomy was performed in 13 patients, and 4 (30.7%) died. Early surgery (necrosectomy and closed peritoneal lavage) was undertaken in 75 patients, with a mortality rate of 39%. In conclusion, the morbidity and mortality rates of ANP can be improved with proper monitoring, adequate supportive care and the judicious use of surgery based on clinical and morphological findings.

  15. Spin labels. Applications in biology

    International Nuclear Information System (INIS)

    Frangopol, T.P.; Frangopol, M.; Ionescu, S.M.; Pop, I.V.; Benga, G.

    1980-11-01

    The main applications of spin labels in the study of biomembranes, enzymes, nucleic acids, in pharmacology, spin immunoassay are reviewed along with the fundamentals of the spin label method. 137 references. (author)

  16. Modeling the effects of labeling

    DEFF Research Database (Denmark)

    Juhl, Hans Jørn; Fjord, Thomas Ahle; Poulsen, Carsten Stig

    A new approach to evaluate the consequences of labeling is presented and applied to test the potential effect of a label on fresh fish. Labeling effects on quality perceptions and overall quality are studied. The empirical study is based on an experimental design and nearly 500 respondents...

  17. Isotopically labelled benzodiazepines

    International Nuclear Information System (INIS)

    Liebman, A.A.

    1987-01-01

    This paper reports on the benzodiazepines which are a class of therapeutic agents. Improvements in the analytical methodology in the areas of biochemistry and pharmacology were significant, particularly in the application of chromatographic and spectroscopic techniques. In addition, the discovery and subsequent development of tritium and carbon-14 as an analytical tool in the biological sciences were essentially post-world war II phenomena. Thus, as these new chemical entities were found to be biologically active, they could be prepared in labeled form for metabolic study, biological half-life determination (pharmacokinetics), tissue distribution study, etc. This use of tracer methodology has been liberally applied to the benzodiazepines and also more recently to the study of receptor-ligand interactions, in which tritium, carbon-11 or fluorine-18 isotopes have been used. The history of benzodiazepines as medicinal agents is indeed an interesting one; an integral part of that history is their use in just about every conceivable labeled form

  18. Stakeholders' views on data sharing in multicenter studies.

    Science.gov (United States)

    Mazor, Kathleen M; Richards, Allison; Gallagher, Mia; Arterburn, David E; Raebel, Marsha A; Nowell, W Benjamin; Curtis, Jeffrey R; Paolino, Andrea R; Toh, Sengwee

    2017-09-01

    To understand stakeholders' views on data sharing in multicenter comparative effectiveness research studies and the value of privacy-protecting methods. Semistructured interviews with five US stakeholder groups. We completed 11 interviews, involving patients (n = 15), researchers (n = 10), Institutional Review Board and regulatory staff (n = 3), multicenter research governance experts (n = 2) and healthcare system leaders (n = 4). Perceptions of the benefits and value of research were the strongest influences toward data sharing; cost and security risks were primary influences against sharing. Privacy-protecting methods that share summary-level data were acknowledged as being appealing, but there were concerns about increased cost and potential loss of research validity. Stakeholders were open to data sharing in multicenter studies that offer value and minimize security risks.

  19. Statistics of the Iomazenil-multicenter study

    International Nuclear Information System (INIS)

    Hasler, P.H.; Beer-Wohlfahrt, H.; Schubiger, P.A.

    1990-01-01

    The 123 I-Ro 16-0154 (= Iomazenil) has been shown as a very potent benzodiazepine antagonist by Beer et al. (1990). In this study the in vitro and in vivo characteristics have been described. The preliminary clinical results revealed clearly images of the benzodiazepine receptor density in the brain. Also storage defects due to pathological CBF and changed receptor density were detected. The Iomazenil showed potential usefulness and therefore extended clinical tests in a multicenter study have been performed. The goals were twofold, first to define the normal benzodiazepine receptor distribution in a healthy human brain and second to investigate the possible diagnostic usefulness of Iomazenil in the case of partial epilepsy. Furthermore, on a few normal volunteers the pharmacokinetics should be determined and some patients with other dieseases (e.g. Alzheimer) would be screened. Some preliminary clinical results have already been published. Hoell et al. (1989) compared the biodistribution of Iomazenil in normal humans with the animal data published (Beer et al., 1990). They concluded that the distribution was similar. The radioactivity concentration in the plasma was virtually cleared after 15 min., cerebral uptake reached a maximum of 10-15 min p.i. and remained stable for about 20 min. Bangerl et al. (1990) found a reduction of benzodiazepine receptors in patients with Lennox-Gaustaut-syndrome. Bartenstein et al. (1989) compared early (30 min.) and late (2h) SPECT-images. They found that early images showed flow-phenomena and receptor binding, whereas late one corresponded clearly to receptor binding. Their findings confirm the results published by Beer et al. (1990). In this work the patient data of all participating clinical centers are evaluated and discussed. (author) 3 figs., 7 tabs., 5 refs

  20. Review of nutrition labeling formats.

    Science.gov (United States)

    Geiger, C J; Wyse, B W; Parent, C R; Hansen, R G

    1991-07-01

    This article examines nutrition labeling history as well as the findings of nine research studies of nutrition labeling formats. Nutrition labeling regulations were announced in 1973 and have been periodically amended since then. In response to requests from consumers and health care professionals for revision of the labeling system, the Food and Drug Administration initiated a three-phase plan for reform of nutrition labeling in 1990. President Bush signed the Nutrition Labeling and Education Act in November 1990. Literature analysis revealed that only nine studies with an experimental design have focused on nutrition labeling since 1971. Four were conducted before 1975, which was the year that nutrition labeling was officially implemented, two were conducted in 1980, and three were conducted after 1986. Only two of the nine studies supported the traditional label format mandated by the Code of Federal Regulations, and one study partially supported it. Four of the nine studies that evaluated graphic presentations of nutrition information found that consumer comprehension of nutrition information was improved with a graphic format for nutrition labeling: three studies supported the use of bar graphs and one study supported the use of a pie chart. Full disclosure (ie, complete nutrient and ingredient labeling) was preferred by consumers in two of the three studies that examined this variable. The third study supported three types of information disclosure dependent upon socioeconomic class. In those studies that tested graphics, a bar graph format was significantly preferred and showed better consumer comprehension than the traditional format.

  1. Linerless label device and method

    KAUST Repository

    Binladen, Abdulkari

    2016-01-14

    This apparatus and method for applying a linerless label to an end user product includes a device with a printer for printing on a face surface of a linerless label, and a release coat applicator for applying a release coat to the face surface of the label; another device including an unwinder unit (103) to unwind a roll of printed linerless label; a belt (108); a glue applicator (102) for applying glue to the belt; a nip roller (106) for contacting and applying pressure to the face surface of the linerless label such that the glue on the belt transfers to the back surface of the linerless label; at least one slitting knife 105) positioned downstream the belt and a rewinder unit (104) positioned downstream the slitting knife; and a third device which die cuts and applies the linerless label to an end user object.

  2. Preliminary Analysis Using Multi-atlas Labeling Algorithms for Tracing Longitudinal Change

    Directory of Open Access Journals (Sweden)

    Eun Young eKim

    2015-07-01

    Full Text Available Multicenter longitudinal neuroimaging has great potential to provide efficient and consistent biomarkers for research of neurodegenerative diseases and aging. In rare disease studies it is of primary importance to have a reliable tool that performs consistently for data from many different collection sites to increase study power. A multi-atlas labeling algorithm is a powerful brain image segmentation approach that is becoming increasingly popular in image processing. The present study examined the performance of multi-atlas labeling tools for subcortical identification using two types of in-vivo image database: Traveling Human Phantom and PREDICT-HD. We compared the accuracy (Dice Similarity Coefficient; DSC and intraclass correlation; ICC, multicenter reliability (Coefficient of Variance; CV, and longitudinal reliability (volume trajectory smoothness and Akaike Information Criterion; AIC of three automated segmentation approaches: two multi-atlas labeling tools, MABMIS and MALF, and a machine-learning-based tool, BRAINSCut. In general, MALF showed the best performance (higher DSC, ICC, lower CV, AIC, and smoother trajectory with a couple of exceptions. First, the results of accumben, where BRAINSCut showed higher reliability, were still premature to discuss their reliability levels since their validity is still in doubt (DSC<0.7, ICC < 0.7. For caudate, BRAINSCut presented slightly better accuracy while MALF showed significantly smoother longitudinal trajectory. We discuss advantages and limitations of these performance variations and conclude that improved segmentation quality can be achieved using multi-atlas labeling methods. While multi-atlas labeling methods are likely to help improve overall segmentation quality, caution has to be taken when one chooses an approach, as our results suggest that segmentation outcome can vary depending on research interest.

  3. Labelled compounds. (Pt. B)

    International Nuclear Information System (INIS)

    Buncel, E.; Jones, J.R.

    1991-01-01

    Since the end of World War II there has been a tremendous increase in the number of compounds that have been synthesized with radioactive or stable isotopes. They have found application in many diverse fields, so much so, that hardly a single area in pure and applied science has not benefited. Not surprisingly it has been reflected in appearance of related publications. The early proceedings of the Symposia on Advances in Trace Methodology were soon followed by various Euratom sponsored meetings in which methods of preparing and storing labelled compounds featured prominently. In due course a resurgence of interest in stable isotopes, brought about by their greater availability (also lower cost) and partly by development of new techniques such as gas chromatography - mass spectrometry (gc-ms), led to the publication of proceedings of several successful conferences. More recently conferences dealing with the synthesis and applications of isotopes and isotopically labelled compounds have been established on a regular basis. In addition to the proceedings of conferences and journal publications individuals left their mark by producing definitive texts, usually on specific nuclides. Only the classic two volume publication of Murray and Williams (Organic syntheses with isotopes, New York 1985), now over 30 years old and out of print, attempted to do justice to several nuclides. With the large amount of work that has been undertaken since then it seems unlikely that an updated edition could be produced. The alternative strategy was to ask scientists currently active to review specific areas and this is the approach adopted in the present series of monographs. In this way it is intended to cover the broad advances that have been made in the synthesis and applications of isotopes and isotopically labelled compounds in the physical and biomedical sciences. (author). refs.; figs.; tabs

  4. From Label to Practice

    DEFF Research Database (Denmark)

    Byrkjeflot, Haldor; Strandgaard, Jesper; Svejenova, Silviya

    2013-01-01

    because NNC was conceived as an identity movement, triggered by active involvement of entrepreneurial leaders from the culinary profession, high-profile political supporters, legitimating scientists, disseminating media, and interpreting audiences. It was facilitated by three mechanisms: First, the use......This article examines the process of creation of new Nordic cuisine (NNC) as a culinary innovation, focusing on the main stages, actors, and mechanisms that shaped the new label and its practices and facilitated its diffusion in the region and internationally. Fast-paced diffusion was possible...

  5. Label and Label-Free Detection Techniques for Protein Microarrays

    Directory of Open Access Journals (Sweden)

    Amir Syahir

    2015-04-01

    Full Text Available Protein microarray technology has gone through numerous innovative developments in recent decades. In this review, we focus on the development of protein detection methods embedded in the technology. Early microarrays utilized useful chromophores and versatile biochemical techniques dominated by high-throughput illumination. Recently, the realization of label-free techniques has been greatly advanced by the combination of knowledge in material sciences, computational design and nanofabrication. These rapidly advancing techniques aim to provide data without the intervention of label molecules. Here, we present a brief overview of this remarkable innovation from the perspectives of label and label-free techniques in transducing nano‑biological events.

  6. Multicenter observational prehospital resuscitation on helicopter study.

    Science.gov (United States)

    Holcomb, John B; Swartz, Michael D; DeSantis, Stacia M; Greene, Thomas J; Fox, Erin E; Stein, Deborah M; Bulger, Eileen M; Kerby, Jeffrey D; Goodman, Michael; Schreiber, Martin A; Zielinski, Martin D; O'Keeffe, Terence; Inaba, Kenji; Tomasek, Jeffrey S; Podbielski, Jeanette M; Appana, Savitri N; Yi, Misung; Wade, Charles E

    2017-07-01

    at any time point, although only 10% of the high-risk sample were able to be matched. Because of the unexpected imbalance in systolic blood pressure, Glasgow Coma Scale, and Injury Severity Score between systems with and without blood products on helicopters, matching was limited, and the results of this study are inconclusive. With few units transfused to each patient and small outcome differences between groups, it is likely large, multicenter, randomized studies will be required to detect survival differences in this important population. Level II.

  7. Distance labeling schemes for trees

    DEFF Research Database (Denmark)

    Alstrup, Stephen; Gørtz, Inge Li; Bistrup Halvorsen, Esben

    2016-01-01

    We consider distance labeling schemes for trees: given a tree with n nodes, label the nodes with binary strings such that, given the labels of any two nodes, one can determine, by looking only at the labels, the distance in the tree between the two nodes. A lower bound by Gavoille et al. [Gavoille...... variants such as, for example, small distances in trees [Alstrup et al., SODA, 2003]. We improve the known upper and lower bounds of exact distance labeling by showing that 1/4 log2(n) bits are needed and that 1/2 log2(n) bits are sufficient. We also give (1 + ε)-stretch labeling schemes using Theta...

  8. Ethics Review of Pediatric Multi-Center Drug Trials

    NARCIS (Netherlands)

    Needham, Allison C.; Kapadia, Mufiza Z.; Offringa, Martin

    2015-01-01

    The assessment of safety and efficacy of therapeutics for children and adolescents requires the use of multi-centered designs. However, the need to obtain ethical approval from multiple independent research ethics boards (REBs) presents as a challenge to investigators and sponsors who must consider

  9. Co-Labeling for Multi-View Weakly Labeled Learning.

    Science.gov (United States)

    Xu, Xinxing; Li, Wen; Xu, Dong; Tsang, Ivor W

    2016-06-01

    It is often expensive and time consuming to collect labeled training samples in many real-world applications. To reduce human effort on annotating training samples, many machine learning techniques (e.g., semi-supervised learning (SSL), multi-instance learning (MIL), etc.) have been studied to exploit weakly labeled training samples. Meanwhile, when the training data is represented with multiple types of features, many multi-view learning methods have shown that classifiers trained on different views can help each other to better utilize the unlabeled training samples for the SSL task. In this paper, we study a new learning problem called multi-view weakly labeled learning, in which we aim to develop a unified approach to learn robust classifiers by effectively utilizing different types of weakly labeled multi-view data from a broad range of tasks including SSL, MIL and relative outlier detection (ROD). We propose an effective approach called co-labeling to solve the multi-view weakly labeled learning problem. Specifically, we model the learning problem on each view as a weakly labeled learning problem, which aims to learn an optimal classifier from a set of pseudo-label vectors generated by using the classifiers trained from other views. Unlike traditional co-training approaches using a single pseudo-label vector for training each classifier, our co-labeling approach explores different strategies to utilize the predictions from different views, biases and iterations for generating the pseudo-label vectors, making our approach more robust for real-world applications. Moreover, to further improve the weakly labeled learning on each view, we also exploit the inherent group structure in the pseudo-label vectors generated from different strategies, which leads to a new multi-layer multiple kernel learning problem. Promising results for text-based image retrieval on the NUS-WIDE dataset as well as news classification and text categorization on several real-world multi

  10. The radioactive labeling of monocytes

    International Nuclear Information System (INIS)

    Ensing, G.J.

    1985-01-01

    With the aim of studying a possible relationship between circulating monocytes and Sternberg-Reed cells investigations were started on the specific labeling of monocytes. In this thesis the literature on the pertinent data has been reviewed and a series of experiments on the monocyte labeling procedure has been described. The principles of cell labeling with radioactive compounds were discussed. 1. Total separation of the particular cell population to be labeled and subsequent labeling with a non-specific radiopharmaceutical. 2. Specific cell labeling in a mixture of cell types based on a well defined affinity of the cell under study for the radiopharmaceutical used. Next the radionuclides that can be used for cell labeling purposes were discussed with special attention for 111 In and its chelates. The principles of radiodosimetry were also discussed shortly. This section was focussed on the radiation dose the labeled cells receive because of the intracellular localized radioactivity. The radiation burden is high in comparison to amounts of radiation known to affect cell viability. A newly developed method for labeling monocytes specifically by phagocytosis of 111 In-Fe-colloid without apparent loss of cells was described in detail. (Auth.)

  11. Labelled molecules, modern research implements

    International Nuclear Information System (INIS)

    Pichat, L.; Langourieux, Y.

    1974-01-01

    Details of the synthesis of carbon 14- and tritium-labelled molecules are examined. Although the methods used are those of classical organic chemistry the preparation of carbon 14-labelled molecules differs in some respects, most noticeably in the use of 14 CO 2 which requires very special handling techniques. For the tritium labelling of organic molecules the methods are somewhat different, very often involving exchange reactions. The following are described in turn: the so-called Wilzbach exchange method; exchange by catalysis in solution; catalytic hydrogenation with tritium; reductions with borotritides. Some applications of labelled molecules in organic chemistry, biochemistry and pharmacology are listed [fr

  12. Radioactive decay and labeled compounds

    International Nuclear Information System (INIS)

    Anon.

    1991-01-01

    This chapter on radioactive decay and labeled compounds has numerous intext equations and worked, sample problems. Topics covered include the following: terms and mathematics of radioactive decay; examples of calculations; graphs of decay equations; radioactivity or activity; activity measurements; activity decay; half-life determinations; labeled compounds. A 20 problem set is also included. 1 ref., 4 figs., 1 tab

  13. Linerless label device and method

    KAUST Repository

    Binladen, Abdulkari

    2016-01-01

    This apparatus and method for applying a linerless label to an end user product includes a device with a printer for printing on a face surface of a linerless label, and a release coat applicator for applying a release coat to the face surface

  14. Nutrition Marketing on Food Labels

    Science.gov (United States)

    Colby, Sarah E.; Johnson, LuAnn; Scheett, Angela; Hoverson, Bonita

    2010-01-01

    Objective: This research sought to determine how often nutrition marketing is used on labels of foods that are high in saturated fat, sodium, and/or sugar. Design and Setting: All items packaged with food labels (N = 56,900) in all 6 grocery stores in Grand Forks, ND were surveyed. Main Outcome Measure(s): Marketing strategy, nutrient label…

  15. 21 CFR 201.70 - Calcium labeling.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Calcium labeling. 201.70 Section 201.70 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.70 Calcium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the calcium content per...

  16. 49 CFR 172.450 - EMPTY label.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false EMPTY label. 172.450 Section 172.450... SECURITY PLANS Labeling § 172.450 EMPTY label. (a) Each EMPTY label, except for size, must be as follows....) in height. (2) The label must be white with black printing. (b) [Reserved] ...

  17. 21 CFR 610.60 - Container label.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Container label. 610.60 Section 610.60 Food and... GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.60 Container label. (a) Full label. The following items shall appear on the label affixed to each container of a product capable of bearing a full...

  18. 49 CFR 172.442 - CORROSIVE label.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false CORROSIVE label. 172.442 Section 172.442... SECURITY PLANS Labeling § 172.442 CORROSIVE label. (a) Except for size and color, the CORROSIVE label must... CORROSIVE label must be white in the top half and black in the lower half. [Amdt. 172-123, 56 FR 66259, Dec...

  19. 16 CFR 460.12 - Labels.

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Labels. 460.12 Section 460.12 Commercial....12 Labels. If you are a manufacturer, you must label all packages of your insulation. The labels must... chart. Labels for these products must state the minimum net weight of the insulation in the package. You...

  20. 49 CFR 172.441 - FISSILE label.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false FISSILE label. 172.441 Section 172.441... SECURITY PLANS Labeling § 172.441 FISSILE label. (a) Except for size and color, the FISSILE label must be... FISSILE label must be white. [69 FR 3669, Jan. 26, 2004] ...

  1. 49 CFR 172.426 - OXIDIZER label.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false OXIDIZER label. 172.426 Section 172.426... SECURITY PLANS Labeling § 172.426 OXIDIZER label. (a) Except for size and color, the OXIDIZER label must be... OXIDIZER label must be yellow. [Amdt. 172-123, 56 FR 66257, Dec. 20, 1991] ...

  2. A better carbon footprint label

    DEFF Research Database (Denmark)

    Thøgersen, John; Nielsen, Kristian S.

    2016-01-01

    , participants saw the original Carbon Trust label and in the other condition they saw the same label, but with traffic light colors added to communicate the product’s relative performance in terms of carbon footprint. All included attributes were found to have a significant impact on consumer choices....... As expected, price and carbon footprint were negatively related to choice. Further, participants preferred organic to non-organic coffee and certification by a public authority. The effect of the carbon label is significantly stronger the more environmentally concerned the consumer is. Using colors...... to indicate relative carbon footprint significantly increases carbon label effectiveness. Hence, a carbon footprint label is more effective if it uses traffic light colors to communicate the product’s relative performance....

  3. Photoaffinity labeling of bacteriorhodopsin

    International Nuclear Information System (INIS)

    Ding, Weidong; Tsipouras, Athanasios; Ok, Hyun; Yamamoto, Toshihiro; Gawinowicz, M.A.; Nakanishi, Koji

    1990-01-01

    14 C-Labeled optically pure 3S- and 3R-(diazoacetoxy)-all-trans-retinals were incorporated separately into bacterioopsin to reconstitute functional bacteriorhodopsin (bR) analogues, 3S- and 3R-diazo-bRs. UV irradiation at 254 nm generated highly reactive carbenes, which cross-linked the radiolabeled retinals to amino acid residues in the vicinity of the β-ionone ring. The 3S- and 3R-diazo analogues were found to cross-link, respectively, to cyanogen bromide fragments CN 7/CN 9 and CN 8/CN 9. More specifically, Thr121 and Gly122 in fragment CN 7 were found to be cross-linked to the 3S-diazo analogue. The identification of cross-linked residues and fragments favors assignments of the seven helices A-G-F-E-D-C-B or B-C-D-E-F-G-A to helices 1-2-3-4-5-6-7 in the two-dimensional electron density map. The present results show that the chromophore chain is oriented with the ionone ring inclined toward the outside of the membrane (the 9-methyl group also faces the extracellular side of the membrane)

  4. Soil Fumigant Labels - Dimethyl Disulfide (DMDS)

    Science.gov (United States)

    Search by EPA registration number, product name, or company and follow the link to the Pesticide Product Labeling System (PPLS) for label details. Updated labels include new safety requirements for buffer zones and related measures.

  5. Mobile Application for Pesticide Label Matching

    Science.gov (United States)

    The label matching application will give inspectors the ability to instantly compare pesticide product labels against state and federal label databases via their cell phone, tablet or other mobile device.

  6. How to Read a Nutrition Facts Label

    Medline Plus

    Full Text Available ... Under Control Figuring Out Food Labels Healthy Food Shopping If My Child Has Food Allergies, What Should ... for Parents Figuring Out Food Labels Smart Supermarket Shopping Figuring Out Fat and Calories Food Labels View ...

  7. 21 CFR 1302.04 - Location and size of symbol on label and labeling.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Location and size of symbol on label and labeling... AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.04 Location and size of symbol on label and labeling. The symbol shall be prominently located on the label or the labeling of the commercial...

  8. Regularized Label Relaxation Linear Regression.

    Science.gov (United States)

    Fang, Xiaozhao; Xu, Yong; Li, Xuelong; Lai, Zhihui; Wong, Wai Keung; Fang, Bingwu

    2018-04-01

    Linear regression (LR) and some of its variants have been widely used for classification problems. Most of these methods assume that during the learning phase, the training samples can be exactly transformed into a strict binary label matrix, which has too little freedom to fit the labels adequately. To address this problem, in this paper, we propose a novel regularized label relaxation LR method, which has the following notable characteristics. First, the proposed method relaxes the strict binary label matrix into a slack variable matrix by introducing a nonnegative label relaxation matrix into LR, which provides more freedom to fit the labels and simultaneously enlarges the margins between different classes as much as possible. Second, the proposed method constructs the class compactness graph based on manifold learning and uses it as the regularization item to avoid the problem of overfitting. The class compactness graph is used to ensure that the samples sharing the same labels can be kept close after they are transformed. Two different algorithms, which are, respectively, based on -norm and -norm loss functions are devised. These two algorithms have compact closed-form solutions in each iteration so that they are easily implemented. Extensive experiments show that these two algorithms outperform the state-of-the-art algorithms in terms of the classification accuracy and running time.

  9. Multi-Center Traffic Management Advisor Operational Field Test Results

    Science.gov (United States)

    Farley, Todd; Landry, Steven J.; Hoang, Ty; Nickelson, Monicarol; Levin, Kerry M.; Rowe, Dennis W.

    2005-01-01

    The Multi-Center Traffic Management Advisor (McTMA) is a research prototype system which seeks to bring time-based metering into the mainstream of air traffic control (ATC) operations. Time-based metering is an efficient alternative to traditional air traffic management techniques such as distance-based spacing (miles-in-trail spacing) and managed arrival reservoirs (airborne holding). While time-based metering has demonstrated significant benefit in terms of arrival throughput and arrival delay, its use to date has been limited to arrival operations at just nine airports nationally. Wide-scale adoption of time-based metering has been hampered, in part, by the limited scalability of metering automation. In order to realize the full spectrum of efficiency benefits possible with time-based metering, a much more modular, scalable time-based metering capability is required. With its distributed metering architecture, multi-center TMA offers such a capability.

  10. Spectral flow, and the spectrum of multicenter solutions

    International Nuclear Information System (INIS)

    Bena, Iosif; Bobev, Nikolay; Warner, Nicholas P.

    2008-01-01

    We discuss 'spectral-flow' coordinate transformations that take asymptotically four-dimensional solutions into other asymptotically four-dimensional solutions. We find that spectral flow can relate smooth three-charge solutions with a multicenter Taub-NUT base to solutions where one or several Taub-NUT centers are replaced by two-charge supertubes, and vice versa. We further show that multiparameter spectral flows can map such Taub-NUT centers to more singular centers that are either D2-D0 or pure D0-brane sources. Since supertubes can depend on arbitrary functions, we establish that the moduli space of smooth horizonless black-hole microstate solutions is classically of infinite dimension. We also use the physics of supertubes to argue that some multicenter solutions that appear to be bound states from a four-dimensional perspective are in fact not bound states when considered from a five- or six-dimensional perspective

  11. Selective backbone labelling of ILV methyl labelled proteins

    International Nuclear Information System (INIS)

    Sibille, Nathalie; Hanoulle, Xavier; Bonachera, Fanny; Verdegem, Dries; Landrieu, Isabelle; Wieruszeski, Jean-Michel; Lippens, Guy

    2009-01-01

    Adding the 13 C labelled 2-keto-isovalerate and 2-oxobutanoate precursors to a minimal medium composed of 12 C labelled glucose instead of the commonly used ( 2 D, 13 C) glucose leads not only to the 13 C labelling of (I, L, V) methyls but also to the selective 13 C labelling of the backbone C α and CO carbons of the Ile and Val residues. As a result, the backbone ( 1 H, 15 N) correlations of the Ile and Val residues and their next neighbours in the (i + 1) position can be selectively identified in HN(CA) and HN(CO) planes. The availability of a selective HSQC spectrum corresponding to the sole amide resonances of the Ile and Val residues allows connecting them to their corresponding methyls by the intra-residue NOE effect, and should therefore be applicable to larger systems

  12. Label Review Training: Module 1: Label Basics, Page 4

    Science.gov (United States)

    Pesticide labels translate results of our extensive evaluations of pesticide products into conditions, directions and precautions that define parameters for use of a pesticide with the goal of ensuring protection of human health and the environment.

  13. Label Review Training: Module 1: Label Basics, Page 6

    Science.gov (United States)

    Page 6, Pesticide labels translate results of our extensive evaluations of pesticide products into conditions, directions and precautions that define parameters for use of a pesticide with the goal of ensuring protection of human health and the environment

  14. Label Review Training: Module 1: Label Basics, Page 9

    Science.gov (United States)

    Pesticide labels translate results of our extensive evaluations of pesticide products into conditions, directions and precautions that define parameters for use of a pesticide with the goal of ensuring protection of human health and the environment.

  15. Label Review Training: Module 1: Label Basics, Page 5

    Science.gov (United States)

    Pesticide labels translate results of our extensive evaluations of pesticide products into conditions, directions and precautions that define parameters for use of a pesticide with the goal of ensuring protection of human health and the environment.

  16. Label Review Training: Module 1: Label Basics, Page 8

    Science.gov (United States)

    Pesticide labels translate results of our extensive evaluations of pesticide products into conditions, directions and precautions that define parameters for use of a pesticide with the goal of ensuring protection of human he

  17. Label Review Training: Module 1: Label Basics, Page 2

    Science.gov (United States)

    Pesticide labels translate results of our extensive evaluations of pesticide products into conditions, directions and precautions that define parameters for use of a pesticide with the goal of ensuring protection of human health and the environment.

  18. Label Review Training: Module 1: Label Basics, Page 3

    Science.gov (United States)

    Pesticide labels translate results of our extensive evaluations of pesticide products into conditions, directions and precautions that define parameters for use of a pesticide with the goal of ensuring protection of human health and the environment.

  19. 16 CFR 306.12 - Labels.

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Labels. 306.12 Section 306.12 Commercial..., CERTIFICATION AND POSTING Label Specifications § 306.12 Labels. All labels must meet the following specifications: (a) Layout—(1) For gasoline labels. The label is 3″ (7.62 cm) wide × 21/2″ (6.35 cm) long. The...

  20. Calculation Of Multicenter Electric Field Integrals Over Slater Type Orbitals

    International Nuclear Information System (INIS)

    Zaim, N.

    2010-01-01

    Using the properties of complete orthonormal sets of Ψ α -exponential type orbitals (α1,0,-1,-2, ...) and the relations for overlap integrals, the calculations for the multicenter electric field integrals of Slater type orbitals are performed. The results of computer calculations are presented. The convergence of the series is tested by calculating concrete cases for the arbitrary values of quantum numbers, orbital parameters and internuclear distances.

  1. Scattering of charged particles by a multicenter potential

    International Nuclear Information System (INIS)

    Gerasimov, O.I.; Stienko, A.G.

    1994-01-01

    Exact expressions are obtained for the amplitude and elastic cross section in the case of scattering of charged particles by a multicenter pseudopotential that includes the Coulomb potential and an arbitrary number of short-range potentials (modeled by zero-range potentials). Asymptotic limits are calculated and explicit expressions are found for the amplitudes of scattering by few-nucleon complexes modeled by superpositions of the Coulomb potential and purely point potentials

  2. New labels for radiation therapy

    Energy Technology Data Exchange (ETDEWEB)

    Kubota, Susumu; Mukai, Minoru; Kato, Hirotoshi (National Inst. of Radiological Sciences, Chiba (Japan))

    1992-12-01

    In simulating radiotherapy, the bone and trachea identified by plain X-P and the other organs, such as the esophagus and bladder, outlined by contrast medium have so far been used as labels. However, irradiation with a high therapeutic ratio is required for an intracorporeal insertion of artificial labels that are identified by X-ray fluoroscopy. For this purpose, metal clips and seed dummies are available, although they cause artifacts in CT scans. Therefore, the authors are using an acupuncture needle and lipiodol for tracing as new artificial labels, since both are identified by X-ray fluoroscopy and CT scan and create few artifacts. (J.P.N.).

  3. Patient identification and tube labelling

    DEFF Research Database (Denmark)

    van Dongen-Lases, Edmée C; Cornes, Michael P; Grankvist, Kjell

    2016-01-01

    of phlebotomy procedures with the CLSI H3-A6 guideline was unacceptably low, and that patient identification and tube labelling are amongst the most critical steps in need of immediate attention and improvement. The process of patient identification and tube labelling is an essential safety barrier to prevent...... patient identity mix-up. Therefore, the EFLM Working Group aims to encourage and support worldwide harmonisation of patient identification and tube labelling procedures in order to reduce the risk of preanalytical errors and improve patient safety. With this Position paper we wish to raise awareness...... and provide recommendations for proper patient and sample identification procedures....

  4. New labels for radiation therapy

    International Nuclear Information System (INIS)

    Kubota, Susumu; Mukai, Minoru; Kato, Hirotoshi

    1992-01-01

    In simulating radiotherapy, the bone and trachea identified by plain X-P and the other organs, such as the esophagus and bladder, outlined by contrast medium have so far been used as labels. However, irradiation with a high therapeutic ratio is required for an intracorporeal insertion of artificial labels that are identified by X-ray fluoroscopy. For this purpose, metal clips and seed dummies are available, although they cause artifacts in CT scans. Therefore, the authors are using an acupuncture needle and lipiodol for tracing as new artificial labels, since both are identified by X-ray fluoroscopy and CT scan and create few artifacts. (J.P.N.)

  5. Selenium-75-labelled foliate compounds

    International Nuclear Information System (INIS)

    1974-01-01

    A saturation method to analyze a foliate is presented; it uses competitive reaction of the compound to be measured and of a radioactive-labelled version of this compound with a reagent specific to this compound present in insufficient quantity to combine with the whole of the compound and its labelled version, separation of the bound compound from its non-bound homologue and measurement of the radioactivity concentration in the bound compound, the non-bound compound or both. The radioactive isotope used in the labelled foliate is selenium 75 [fr

  6. Quality control of labelled compounds

    International Nuclear Information System (INIS)

    Matucha, M.

    1979-01-01

    Some advantages and disadvantages of methods used for quality control of organic labelled compounds (1 31 I, 14 C) are shortly discussed. The methods used are electrophoresis, ultraviolet and infrared spectrometry, radiogas and thin-layer chromatography. (author)

  7. Labelling GM-free Products

    DEFF Research Database (Denmark)

    Punt, Maarten; Venus, Thomas; Wesseler, Justus

    2016-01-01

    Food suppliers in the EU must comply with labelling regulations for genetically modified organisms (GMOs). However, excluded from mandatory labelling are food products derived from animals fed with GM feed (mainly GM soybean in the EU). Because of this labelling exemption, consumers are unable....... We asked them whether they produce ‘GM-free’ and to assess the ‘GM-free’ market in terms of (1) the current status, (2) potential benefits, (3) limitations and (4) risks. We find that smaller dairy companies mostly switch completely, whereas ‘GM-free’ production of larger dairy companies is often...... to identify which animal products were derived without the use of GMOs. Therefore, Germany and other countries introduced voluntary ‘GM-free’ labelling legislations or guidelines that allow companies to signal that their products are ‘GM-free’. We present the results of a survey among German dairy companies...

  8. Canonical Labelling of Site Graphs

    Directory of Open Access Journals (Sweden)

    Nicolas Oury

    2013-06-01

    Full Text Available We investigate algorithms for canonical labelling of site graphs, i.e. graphs in which edges bind vertices on sites with locally unique names. We first show that the problem of canonical labelling of site graphs reduces to the problem of canonical labelling of graphs with edge colourings. We then present two canonical labelling algorithms based on edge enumeration, and a third based on an extension of Hopcroft's partition refinement algorithm. All run in quadratic worst case time individually. However, one of the edge enumeration algorithms runs in sub-quadratic time for graphs with "many" automorphisms, and the partition refinement algorithm runs in sub-quadratic time for graphs with "few" bisimulation equivalences. This suite of algorithms was chosen based on the expectation that graphs fall in one of those two categories. If that is the case, a combined algorithm runs in sub-quadratic worst case time. Whether this expectation is reasonable remains an interesting open problem.

  9. Clinical evaluation of a dressing with poly absorbent fibres and a silver matrix for managing chronic wounds at risk of infection: a non comparative trial.

    Science.gov (United States)

    Dalac, S; Sigal, L; Addala, A; Chahim, M; Faivre-Carrere, C; Lemdjadi, Z; Bohbot, S

    2016-09-01

    To assess the efficacy, safety and acceptability of a new silver poly absorbent dressing (UrgoCleanAg) in the local management of exudative chronic wounds at risk of infection, with inflammatory signs suggesting heavy bacterial load. This prospective, multicentre, non-comparative clinical trial was conducted in French hospital wards (dermatology and vascular medicine) or specialised private-practice physicians. Patients were considered at high-risk of infection when presenting with at least three of five selected inflammatory clinical signs, suggesting a heavy bacterial load (pain between two dressing changes, erythema, oedema, malodorous wound and presence of a heavy exudate). They were treated for a maximum period of four weeks, and followed by the physician on a weekly basis, including a clinical examination, area tracings and photographs. The primary efficacy criterion of the trial was the relative wound surface area reduction at the end of the four weeks of treatment. Acceptability was documented by the nursing staff at each dressing change between the weekly evaluations. We recruited 37 patients with chronic wounds. Wound surface area, mostly covered by sloughy tissue, was reduced by 32.5% at the end of the treatment (median value), while the clinical score (maximum value of 5, based on inflammatory clinical signs) decreased from 4.0 to 2.0. Effective debridement properties were documented (62.5% relative reduction of sloughy tissue at week 4; 58.8% of debrided wounds at week 4) and improvement of the periwound skin status was noted (healthy for 28.6% of the patients at week 4 versus 2.7% at baseline). In addition, the tested wound dressing presented a good safety profile associated to a high level of acceptability, noted by both patients and nursing staff. These clinical data support that the tested dressing is a credible therapeutic alternative for the management of chronic wounds at risk of infection with inflammatory signs suggesting heavy bacterial load.

  10. Synthesis of isotopically labelled salicylates

    International Nuclear Information System (INIS)

    Hawkins, D.R.; Pryor, R.W.

    1981-01-01

    [ 13 C-carboxyl]Salicylic acid has been prepared by carbonation of 2-benzyloxybromobenzene followed by reductive debenzylation. Deuterium and tritium labelled salicylic acid and 2 H 2 / 13 C-salicylic acid were prepared by reduction of the 3,5-dibromo derivatives using Raney Ni-Al. Deuterium labelled salicylic acid containing up to four deuterium atoms was prepared by catalytic exchange with Raney Ni-Al in 5% NaOD/D 2 O. (author)

  11. Mindboggle: Automated brain labeling with multiple atlases

    International Nuclear Information System (INIS)

    Klein, Arno; Mensh, Brett; Ghosh, Satrajit; Tourville, Jason; Hirsch, Joy

    2005-01-01

    To make inferences about brain structures or activity across multiple individuals, one first needs to determine the structural correspondences across their image data. We have recently developed Mindboggle as a fully automated, feature-matching approach to assign anatomical labels to cortical structures and activity in human brain MRI data. Label assignment is based on structural correspondences between labeled atlases and unlabeled image data, where an atlas consists of a set of labels manually assigned to a single brain image. In the present work, we study the influence of using variable numbers of individual atlases to nonlinearly label human brain image data. Each brain image voxel of each of 20 human subjects is assigned a label by each of the remaining 19 atlases using Mindboggle. The most common label is selected and is given a confidence rating based on the number of atlases that assigned that label. The automatically assigned labels for each subject brain are compared with the manual labels for that subject (its atlas). Unlike recent approaches that transform subject data to a labeled, probabilistic atlas space (constructed from a database of atlases), Mindboggle labels a subject by each atlas in a database independently. When Mindboggle labels a human subject's brain image with at least four atlases, the resulting label agreement with coregistered manual labels is significantly higher than when only a single atlas is used. Different numbers of atlases provide significantly higher label agreements for individual brain regions. Increasing the number of reference brains used to automatically label a human subject brain improves labeling accuracy with respect to manually assigned labels. Mindboggle software can provide confidence measures for labels based on probabilistic assignment of labels and could be applied to large databases of brain images

  12. 21 CFR 332.31 - Professional labeling.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Professional labeling. 332.31 Section 332.31 Food... HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 332.31 Professional labeling. (a) The labeling of the product provided to health professionals (but not to the general public) may...

  13. 21 CFR 349.80 - Professional labeling.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Professional labeling. 349.80 Section 349.80 Food... HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 349.80 Professional labeling. The labeling of any OTC ophthalmic demulcent drug product provided to health professionals (but...

  14. 21 CFR 341.90 - Professional labeling.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Professional labeling. 341.90 Section 341.90 Food... HUMAN USE Labeling § 341.90 Professional labeling. The labeling of the product provided to health professionals (but not to the general public) may contain the following additional dosage information for...

  15. 21 CFR 336.80 - Professional labeling.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Professional labeling. 336.80 Section 336.80 Food... HUMAN USE ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 336.80 Professional labeling. The labeling provided to health professionals (but not to the general public) may contain the...

  16. Use of labeled compounds in tracer experiments

    International Nuclear Information System (INIS)

    Anon.

    1991-01-01

    The use of radiotracers in research has become common. This chapter looks at some of the underlying assumptions and advantages of labeled compounds: advantages of radiotracers; availability of suitable tracers and labeled compounds; purity of labeled compounds; autoradiolysis; storage of labeled compounds; detection systems for chromatography and electrophoretic methods. 14 refs., 2 figs

  17. 40 CFR 211.108 - Sample label.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Sample label. 211.108 Section 211.108 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) NOISE ABATEMENT PROGRAMS PRODUCT NOISE LABELING General Provisions § 211.108 Sample label. Examples of labels conforming to the requirements of...

  18. 21 CFR 610.61 - Package label.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Package label. 610.61 Section 610.61 Food and... GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.61 Package label. The following items shall appear on the label affixed to each package containing a product: (a) The proper name of the product; (b...

  19. 16 CFR 309.17 - Labels.

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Labels. 309.17 Section 309.17 Commercial... ALTERNATIVE FUELS AND ALTERNATIVE FUELED VEHICLES Requirements for Alternative Fuels Label Specifications § 309.17 Labels. All labels must meet the following specifications: (a) Layout: (1) Non-liquid...

  20. Clinical efficacy and tolerability of praziquantel for intestinal and urinary schistosomiasis-a meta-analysis of comparative and non-comparative clinical trials.

    Directory of Open Access Journals (Sweden)

    Julien Zwang

    Full Text Available Extensive use of praziquantel for treatment and control of schistosomiasis requires a comprehensive understanding of efficacy and safety of various doses for different Schistosoma species.A systematic review and meta-analysis of comparative and non-comparative trials of praziquantel at any dose for any Schistosoma species assessed within two months post-treatment. Of 273 studies identified, 55 were eligible (19,499 subjects treated with praziquantel, control treatment or placebo. Most studied were in school-aged children (64%, S. mansoni (58%, and the 40 mg/kg dose (56%; 68% of subjects were in Africa. Efficacy was assessed as cure rate (CR, n=17,017 and egg reduction rate (ERR, n=13,007; safety as adverse events (AE incidence. The WHO-recommended dose of praziquantel 40 mg/kg achieved CRs of 94.7% (95%CI 92.2-98.0 for S. japonicum, 77.1% (68.4-85.1 for S. haematobium, 76.7% (95%CI 71.9-81.2 for S. mansoni, and 63.5% (95%CI 48.2-77.0 for mixed S. haematobium/S. mansoni infections. Using a random-effect meta-analysis regression model, a dose-effect for CR was found up to 40 mg/kg for S. mansoni and 30 mg/kg for S. haematobium. The mean ERR was 95% for S. japonicum, 94.1% for S. haematobium, and 86.3% for S. mansoni. No significant relationship between dose and ERR was detected. Tolerability was assessed in 40 studies (12,435 subjects. On average, 56.9% (95%CI 47.4-67.9 of the subjects receiving praziquantel 40 mg/kg experienced an AE. The incidence of AEs ranged from 2.3% for urticaria to 31.1% for abdominal pain.The large number of subjects allows generalizable conclusions despite the inherent limitations of aggregated-data meta-analyses. The choice of praziquantel dose of 40 mg/kg is justified as a reasonable compromise for all species and ages, although in a proportion of sites efficacy may be lower than expected and age effects could not be fully explored.

  1. A brief history of cell labelling

    International Nuclear Information System (INIS)

    Peters, A.M.

    2005-01-01

    The term cell labelling is usually used in the context of labelled leukocytes for imaging inflammation and labelled platelets for imaging thrombosis. Erythrocyte labelling for in vitro measurements of red cell life span, in vivo measurements of splenic red cell pooling, radionuclide ventriculography and imaging sites of bleeding has developed rather separately and has a different history. Labelled platelets and leukocytes were originally developed for cell kinetic studies. Since the current-day applications of labelled platelets and leukocytes depend on a clear understanding of cell kinetics, these classical studies are important and relevant to the history of cell labelling

  2. 49 CFR 172.430 - POISON label.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false POISON label. 172.430 Section 172.430... SECURITY PLANS Labeling § 172.430 POISON label. (a) Except for size and color, the POISON label must be as follows: EC02MR91.029 (b) In addition to complying with § 172.407, the background on the POISON label must...

  3. ML-MG: Multi-label Learning with Missing Labels Using a Mixed Graph

    KAUST Repository

    Wu, Baoyuan; Lyu, Siwei; Ghanem, Bernard

    2015-01-01

    This work focuses on the problem of multi-label learning with missing labels (MLML), which aims to label each test instance with multiple class labels given training instances that have an incomplete/partial set of these labels (i.e. some

  4. Multi-label Learning with Missing Labels Using Mixed Dependency Graphs

    KAUST Repository

    Wu, Baoyuan; Jia, Fan; Liu, Wei; Ghanem, Bernard; Lyu, Siwei

    2018-01-01

    This work focuses on the problem of multi-label learning with missing labels (MLML), which aims to label each test instance with multiple class labels given training instances that have an incomplete/partial set of these labels (i.e., some

  5. Positron emitter labeled enzyme inhibitors

    International Nuclear Information System (INIS)

    Fowler, J.S.; MacGregor, R.R.; Wolf, A.P.; Langstrom, B.

    1990-01-01

    This invention involves a new strategy for imagining and mapping enzyme activity in the living human and animal body using positron emitter-labeled suicide enzyme inactivators or inhibitors which become covalently bound to the enzyme as a result of enzymatic catalysis. Two such suicide inactivators for monoamine oxidase have been labeled with carbon-11 and used to map the enzyme subtypes in the living human and animal body using PET. By using positron emission tomography to image the distribution of radioactivity produced by the body penetrating radiation emitted by carbon-11, a map of functionally active monoamine oxidase activity is obtained. Clorgyline and L-deprenyl are suicide enzyme inhibitors and irreversibly inhibit monoamine oxidase. When these inhibitors are labeled with carbon-11 they provide selective probes for monoamine oxidase localization and reactivity in vivo using positron emission tomography

  6. Sustainability labels on food products

    DEFF Research Database (Denmark)

    Grunert, Klaus G; Hieke, Sophie; Wills, Josephine

    2014-01-01

    of sustainability was limited, but understanding of four selected labels (Fair Trade, Rainforest Alliance, Carbon Footprint, and Animal Welfare) was better, as some of them seem to be self-explanatory. The results indicated a low level of use, no matter whether use was measured as self-reported use of different......This study investigates the relationship between consumer motivation, understanding and use of sustainability labels on food products (both environmental and ethical labels), which are increasingly appearing on food products. Data was collected by means of an online survey implemented in the UK......, France, Germany, Spain, Sweden, and Poland, with a total sample size of 4408 respondents. Respondents expressed medium high to high levels of concern with sustainability issues at the general level, but lower levels of concern in the context of concrete food product choices. Understanding of the concept...

  7. Melatonin labeled with hydrogen isotopes

    International Nuclear Information System (INIS)

    Dmitrevskaya, L.I.; Smushkevich, Yu.I.; Kurkovskaya, L.N.; Ponomarenko, N.K.; Suvorov, N.N.

    1989-01-01

    A study has been made of isotope exchange between melatonin and deuterium (D 2 O) or tritium (HTO) oxide under different conditions. The ease of isotope exchange for the indole ring hydrogens of melatonin in an acidic medium decreases over the series H 4 > H 2 H 6 >> H 7 , enabling the authors to process a route for production of melatonin labeled with hydrogen isotopes at positions 4,6, and 2 of the indole ring. A method has been suggested for producing melatonin labeled with hydrogen isotopes at position 2 by desulfurization of 2-(2,4-dinitro-phenylsulfenyl)melatonin at Ni(Re) (D)

  8. Fluorine-18 labeling of proteins

    International Nuclear Information System (INIS)

    Kilbourn, M.R.; Dence, C.S.; Welch, M.J.; Mathias, C.J.

    1987-01-01

    Two fluorine-18-labeled reagents, methyl 3-[ 18 F]fluoro-5-nitrobenzimidate and 4-[ 18 F]fluorophenacyl bromide, have been prepared for covalent attachment of fluorine-18 to proteins. Both reagents can be prepared in moderate yields (30-50%, EOB) in synthesis times of 50-70 min. Reaction of these reagents with proteins (human serum albumin, human fibrinogen, and human immunoglobulin A) is pH independent, protein concentration dependent, and takes 5-60 min at mild pH (8.0) and temperature (25-37 degrees C), in yields up to 95% (corrected). The 18 F-labeled proteins are purified by size exclusion chromatography

  9. Melatonin labelled by hydrogen isotopes

    International Nuclear Information System (INIS)

    Dmitrevskaya, L.I.; Smushkevich, Yu.I.; Kurkovskaya, L.N.; Ponomarenko, N.K.; Suvorov, N.N.

    1988-01-01

    Isotope exchange of melatonin with deuterium (D 2 O) and tritium (HTO) oxides under different conditions is studied. Simplicity of isotope exchange of hydrogens of the indole ring of melatonin in the acidic medium decreases in series H 4 >H 2 >H 6 >>H 7 , that permits to suggest the way of melatonin preparation labelled by hydrogen isotopes in positions 4,6 and 2 of the indole ring. The way of melatonin preparation labelled by hydrogen isotopes in position 2 according to the reaction of desulfation 2-(2,4-dinitrophenylsulphenyl) melatonin at catalyst Ni(Re)(D) is suggested

  10. Radioisotope methods for leucocyte labelling

    International Nuclear Information System (INIS)

    Kostadinova, I.; Kovacheva, S.

    1988-01-01

    A review is made of the labelling methods with the following tracers: 3 H-thymidine, 32 P-DP, 111 In (oxine, tropolon, acetylacetone, MERC), 99m Tc (reduced 99m Tc, lypophyl 99m Tc-complexes and 99m Tc-colloids). The main diagnosis areas are mentioned: abdominal abscesses and inflammations, inflammation foci of skeleton or of implanted prosthesis; acute myocardial infarction, bacterial endocarditis, rejection of kydney transplantations or vascular grafts. It is concluded that labelled leucocytes are very reliable for noninvasive diagnosis of inflammation foci with unclear localization

  11. Radioisotope methods for leucocyte labelling

    Energy Technology Data Exchange (ETDEWEB)

    Kostadinova, I; Kovacheva, S [Meditsinska Akademiya, Sofia (Bulgaria). Katedra po Rentgenologiya i Radiologiya

    1988-01-01

    A review is made of the labelling methods with the following tracers: {sup 3}H-thymidine, {sup 32}P-DP, {sup 111}In (oxine, tropolon, acetylacetone, MERC), {sup 99m}Tc (reduced {sup 99m}Tc, lypophyl {sup 99m}Tc-complexes and {sup 99m}Tc-colloids). The main diagnosis areas are mentioned: abdominal abscesses and inflammations, inflammation foci of skeleton or of implanted prosthesis; acute myocardial infarction, bacterial endocarditis, rejection of kydney transplantations or vascular grafts. It is concluded that labelled leucocytes are very reliable for noninvasive diagnosis of inflammation foci with unclear localization.

  12. Synthesis of radioiodinated labeled peptides

    International Nuclear Information System (INIS)

    Matloobi, M.; Rafii, H.; Beigi, D.; Khalaj, A.; Kamali-Dehghan, M.

    2003-01-01

    Optimization of radioiodination of peptides is covered by both a direct method in which a constituent tyrosine residue is labeled and indirect method by using an iodinated derivative (SIB) of N succinimidyl 3-(tri-n-butylstannyl) benzoate (ATE) as the intermediate. Radioiodination of IgG and FMLF were performed by direct method using Chloramine-T as an oxidant but since Formyl-Methyl-Leucyl-Phenylalanine, FMLF, does not lend itself for direct radioiodination we performed labeling of FMLF by indirect method via radioiodined SIB at different pH. (author)

  13. A multicenter, randomized controlled trial of individualized occupational therapy for patients with schizophrenia in Japan

    Science.gov (United States)

    Ohori, Manami; Inagaki, Yusuke; Shimooka, Yuko; Sugimura, Naoya; Ishihara, Ikuyo; Yoshida, Tomotaka

    2018-01-01

    The individualized occupational therapy (IOT) program is a psychosocial program that we developed to facilitate proactive participation in treatment and improve cognitive functioning and other outcomes for inpatients with acute schizophrenia. The program consists of motivational interviewing, self-monitoring, individualized visits, handicraft activities, individualized psychoeducation, and discharge planning. This multicenter, open-labeled, blinded-endpoint, randomized controlled trial evaluated the impact of adding IOT to a group OT (GOT) program as usual for outcomes in recently hospitalized patients with schizophrenia in Japanese psychiatric hospitals setting compared with GOT alone. Patients with schizophrenia were randomly assigned to the GOT+IOT group or the GOT alone group. Among 136 randomized patients, 129 were included in the intent-to-treat population: 66 in the GOT+IOT and 63 in the GOT alone groups. Outcomes were administered at baseline and discharge or 3 months following hospitalization including the Brief Assessment of Cognition in Schizophrenia Japanese version (BACS-J), the Schizophrenia Cognition Rating Scale Japanese version, the Social Functioning Scale Japanese version, the Global Assessment of Functioning scale, the Intrinsic Motivation Inventory Japanese version (IMI-J), the Morisky Medication Adherence Scale-8 (MMAS-8), the Positive and Negative Syndrome Scale (PANSS), and the Japanese version of Client Satisfaction Questionnaire-8 (CSQ-8J). Results of linear mixed effects models indicated that the IOT+GOT showed significant improvements in verbal memory (p IOT demonstrated significant improvements on the CSQ-8J compared with the GOT alone (p IOT program and its effectiveness for improving cognitive impairment and other outcomes in patients with schizophrenia. PMID:29621261

  14. Hemorrhoids and matrix metalloproteinases: A multicenter study on the predictive role of biomarkers.

    Science.gov (United States)

    Serra, Raffaele; Gallelli, Luca; Grande, Raffaele; Amato, Bruno; De Caridi, Giovanni; Sammarco, Giuseppe; Ferrari, Francesco; Butrico, Lucia; Gallo, Gaetano; Rizzuto, Antonia; de Franciscis, Stefano; Sacco, Rosario

    2016-02-01

    An association between hemorrhoidal disease and matrix metalloproteinases (MMPs) has been described previously. MMPs regulate extracellular structural proteins and tissue remodeling. Neutrophil gelatinase-associated lipocalin (NGAL) is involved in the regulation of MMP activity. The aim of this work was to study the relationship between tissue immunoreactive levels of MMPs and NGAL and different stages of hemorrhoids. In a multicenter, open-label, prospective study, the population under investigation consisted of 2 groups: group I (with symptomatic hemorrhoids; Goligher grade I-IV) and group II (healthy volunteers). We enrolled 97 patients with hemorrhoids: 21 with grade I hemorrhoids, 37 with grade II, 14 with grade III, and 25 with grade IV. Finally, 90 healthy volunteers (53 males and 37 females; age range, 19-70 years; median, 56) were enrolled in group II. Enzyme-linked immunosorbent assay and Western blot analysis revealed greater levels of immunoreactive MMPs and NGAL in all patients with hemorrhoids. We recorded significantly greater levels of MMP-1 and MMP-3 in grade I and II patients compared with control, and greater levels of MMP-3, MMP-7, MMP-8, and MMP-9 in grade III compared with grade II. MMP-9 and NGAL were particularly increased in patients with grade IV especially in case of thrombosed hemorrhoids. These results provide potentially important insights into the understanding of the natural history of hemorrhoids. MMPs and NGAL play a role in development of disease and may represent molecular markers for the complications such as hemorrhoidal thrombosis. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Food quality labels from the producers’ perspective

    Directory of Open Access Journals (Sweden)

    Šárka Velčovská

    2016-09-01

    Full Text Available The paper deals with analysing the food producer attitudes towards quality labels. The Klasa label, as the most known and the most frequently used food quality label in the Czech Republic, have become the subject of investigation. The aim of the research was to identify the benefits and problems arising from the certification process and the label use. Primary data were collected in online survey based on standardized questionnaire. In census, 86 respondents from the total 218 producers with the Klasa label in the Czech Republic completed the questionnaire. The most of producers (72% have a longer experience with the label, they are using the label for more than four years. The producers’ expectations from the label were fulfilled only partially. A poor state marketing support and missing marketing strategy were identified as general problems of the label. Specific perceived problems are formalities connected with the certification process and certification of poor-quality products. Correlation analysis, t-test and Pearson chi-square test were calculated to discover relations between variables. The results of the study can be beneficial to both, food producers as well as administrator of the label. Identified problems could help them to improve marketing strategy of the label in order to manage the label in effective way and use all benefits arising from the certification. Administrator of the label should make the certification process more effective and transparent, promotion should be focused on the explanation to consumers what the Klasa label guarantees.

  16. A multicenter, open-label study of the efficacy and safety of telmisartan in mild to moderate hypertensive patients

    Directory of Open Access Journals (Sweden)

    Plavnik Frida Liane

    2002-01-01

    Full Text Available OBJECTIVE: To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with ABPM. METHODS: Initially, 163 patients over 18 were selected, regardless of sex, with blood pressure levels >140/90mmHg at visit 1, which was confirmed at visit 2. One hundred thirty-four patients completed the study. After a 4-week placebo run-in phase, telmisartan 40mg/daily was given for 6 weeks. In those patients whose blood pressure (BP levels were lower than 140/90mmHg, the same dosage was kept for an additional period of 6 weeks. For those who had BP higher than 140/90mmHg, the dosage was increased to 80mg/daily. Sixty-two patients were included in a subgroup that underwent ABPM 3 different times during the study. RESULTS: In the overall group, blood pressure reduction ranged from 162.3±14.5/101.3±5.75 mmHg (baseline to 147.3±20.1/90.8±10.9 mmHg (week 12 (p<0.05. Mean blood pressure decreases were 14.4mmHg for systolic BP and 10.3mmHg for diastolic BP, after 12 weeks of active treatment. A subanalysis showed that 47 (35% patients took telmisartan 40mg throughout the study and 81 (65% had the dosage increased to 80mg daily. Using ABPM, an 8-mmHg reduction in systolic BP as well as a 5-mmHg reduction in diastolic BP were observed, when compared with baseline values in the final 6 hours (18-24 hours after the last dose of study medication. CONCLUSION: Our results confirm that telmisartan given once a day is effective in reducing blood pressure levels in mild to moderate hypertensive patients. This reduction occurs in a sustained and gradual manner during a 24-hour period confirmed by ABPM.

  17. The Japan Statin Treatment Against Recurrent Stroke (J-STARS: A Multicenter, Randomized, Open-label, Parallel-group Study

    Directory of Open Access Journals (Sweden)

    Naohisa Hosomi

    2015-09-01

    Funding: This study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan. After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and Innovation.

  18. Comparative effectiveness of switching paroxetine formulation for treatment of major depressive disorder: an open-label multicenter study

    Directory of Open Access Journals (Sweden)

    Otsubo T

    2018-04-01

    Full Text Available Tempei Otsubo,1 Yoshinori Watanabe,2,3 Seiji Hongo,3 Mikichika Inoue,4 Kimiko Akimoto,4 Ken Murakami,5 Ryutaro Takahashi,6 Toshiaki Kikuchi7 1Department of Psychiatry, Tokyo Women’s Medical University Medical Center East, Tokyo, Japan; 2Himorogi Psychiatric Institute, Tokyo, Japan; 3Nanko Clinic of Psychiatry, Shirakawa, Japan; 4Ikebukuro Internal Medicine, Tokyo, Japan; 5Murakami Hospital, Tokyo, Japan; 6Takahashi Clinic, Tokyo, Japan; 7Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan Aim: To assess the effectiveness and safety of switching the antidepressant formulation from immediate-release (IR to controlled-release (CR paroxetine in patients with major depressive disorder (MDD. Patients and methods: A total of 113 outpatients with MDD diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, and treated with a stable dose of IR paroxetine for at least 6 months were enrolled. Patients were then switched to CR paroxetine for 8 weeks. Effectiveness was evaluated by scores on the Himorogi Self-Rating Depression/Anxiety Scales (HSDS/HSAS and the Clinical Global Impression – Severity (CGI-S. Safety was evaluated based on the reported adverse drug reactions (ADRs. Medication satisfaction and preference were assessed based on questionnaire responses using Likert-type scales. Results: The overall patient HSDS/HSAS scores significantly improved after switching from IR to CR paroxetine (P<0.001. Furthermore, CR paroxetine was superior to IR paroxetine (P<0.001 according to the results of the CGI-S evaluation. ADRs were experienced by 14 (12.4% patients, including dry mouth, nausea/vomiting, somnolence/drowsiness, and wakefulness/arousal during sleep. Satisfaction and preference for paroxetine improved after switching to the CR formulation (P<0.001; chi-square test. Conclusion: These results suggest that switching the treatment from IR to CR paroxetine could improve depressive symptoms and decrease ADRs. However, these results may have been caused by the psychological effect of drug switching. Hence, future studies with blinded evaluation methods are required to confirm and expand our findings. Keywords: depression, controlled-release paroxetine, drug formulation, antidepressant, immediate-release

  19. Ibuprofen plus paracetamol versus ibuprofen in acute low back pain: a randomized open label multicenter clinical study

    Directory of Open Access Journals (Sweden)

    Predrag Ostojic

    2017-01-01

    Full Text Available Objective: to estimate whether combination of ibuprofen and paracetamol is more effective than ibuprofen in monotherapy, in the treatment of acute low back pain. Methods: 80 adult patients with acute low back pain were randomized into two subgroups. In the first subgroup, 40 patients were treated with ibuprofen 400mg three times a day (TID, whilst patients in the second subgroup (n=40 were treated with a fixed-dose combination tablet of ibuprofen 200mg plus paracetamol 325mg TID, for three consecutive days. Patients were followed for another 7 days. Efficacy and tolerability of both treatment options was assessed. Results: A statistically significant decrease in pain intensity, assessed using a visual analogue scale (p

  20. Multicenter Off-Label Use of Nit-Occlud Coil in Retrograde Closure of Small Patent Ductus Arteriosus.

    Science.gov (United States)

    Zanjani, Keyhan Sayadpour; Sobhy, Rodina; El-Kaffas, Rania; El-Sisi, Amal

    2017-04-01

    We studied the safety and efficacy of closing patent ductus arteriosus by Nit-Occlud coils via retrograde approach. This is a retrospective study of 46 attempts to close ducts by this method in two hospitals in Egypt and Iran. Ductus arteriosus was crossed by left or right Judkins or endhole catheters. The coil was delivered via the same catheter or the provided endhole catheter after exchange. The procedure was successful in 42 out of 46 attempts. Fluoroscopy and procedural times were significantly shorter when the catheter was not exchanged. This method is effective and safe for the closure of small ducts. Crossing the duct and delivering the coil by a left Judkins catheter is the easiest and fastest way to perform this method.

  1. Ibuprofen plus paracetamol versus ibuprofen in acute low back pain: a randomized open label multicenter clinical study.

    Science.gov (United States)

    Ostojic, Predrag; Radunovic, Goran; Lazovic, Milica; Tomanovic-Vujadinovic, Sanja

    2017-01-01

    to estimate whether combination of ibuprofen and paracetamol is more effective than ibuprofen in monotherapy, in the treatment of acute low back pain. 80 adult patients with acute low back pain were randomized into two subgroups. In the first subgroup, 40 patients were treated with ibuprofen 400mg three times a day (TID), whilst patients in the second subgroup (n=40) were treated with a fixed-dose combination tablet of ibuprofen 200mg plus paracetamol 325mg TID, for three consecutive days. Patients were followed for another 7 days. Efficacy and tolerability of both treatment options was assessed. A statistically significant decrease in pain intensity, assessed using a visual analogue scale (pibuprofen monotherapy reported minor gastric intolerability. compared to ibuprofen monotherapy, combination of ibuprofen and paracetamol may provide faster and longer analgesia in patients with acute low back pain, with equally favorable effect on mobility and functional ability and similar tolerability.

  2. Descriptive epidemiology of the Multicenter ACL Revision Study (MARS) cohort.

    Science.gov (United States)

    Wright, Rick W; Huston, Laura J; Spindler, Kurt P; Dunn, Warren R; Haas, Amanda K; Allen, Christina R; Cooper, Daniel E; DeBerardino, Thomas M; Lantz, Brett Brick A; Mann, Barton J; Stuart, Michael J

    2010-10-01

    Revision anterior cruciate ligament (ACL) reconstruction has worse outcomes than primary reconstructions. Predictors for these worse outcomes are not known. The Multicenter ACL Revision Study (MARS) Group was developed to perform a multisurgeon, multicenter prospective longitudinal study to obtain sufficient subjects to allow multivariable analysis to determine predictors of clinical outcome. To describe the formation of MARS and provide descriptive analysis of patient demographics and clinical features for the initial 460 enrolled patients to date in this prospective cohort. Cross-sectional study; Level of evidence, 2. After training and institutional review board approval, surgeons began enrolling patients undergoing revision ACL reconstruction, recording patient demographics, previous ACL reconstruction methods, intra-articular injuries, and current revision techniques. Enrolled subjects completed a questionnaire consisting of validated patient-based outcome measures. As of April 1, 2009, 87 surgeons have enrolled a total of 460 patients (57% men; median age, 26 years). For 89%, the reconstruction was the first revision. Mode of failure as deemed by the revising surgeon was traumatic (32%), technical (24%), biologic (7%), combination (37%), infection (MARS Group has been able to quickly accumulate the largest revision ACL reconstruction cohort reported to date. Traumatic reinjury is deemed by surgeons to be the most common single mode of failure, but a combination of factors represents the most common mode of failure. Allograft graft choice is more common in the revision setting than autograft. Concomitant knee injury is extremely common in this population.

  3. Intraoperative Death During Cervical Spinal Surgery: A Retrospective Multicenter Study.

    Science.gov (United States)

    Wang, Jeffrey C; Buser, Zorica; Fish, David E; Lord, Elizabeth L; Roe, Allison K; Chatterjee, Dhananjay; Gee, Erica L; Mayer, Erik N; Yanez, Marisa Y; McBride, Owen J; Cha, Peter I; Arnold, Paul M; Fehlings, Michael G; Mroz, Thomas E; Riew, K Daniel

    2017-04-01

    A retrospective multicenter study. Routine cervical spine surgeries are typically associated with low complication rates, but serious complications can occur. Intraoperative death is a very rare complication and there is no literature on its incidence. The purpose of this study was to determine the intraoperative mortality rates and associated risk factors in patients undergoing cervical spine surgery. Twenty-one surgical centers from the AOSpine North America Clinical Research Network participated in the study. Medical records of patients who received cervical spine surgery from January 1, 2005, to December 31, 2011, were reviewed to identify occurrence of intraoperative death. A total of 258 patients across 21 centers met the inclusion criteria. Most of the surgeries were done using the anterior approach (53.9%), followed by posterior (39.1%) and circumferential (7%). Average patient age was 57.1 ± 13.2 years, and there were more male patients (54.7% male and 45.3% female). There was no case of intraoperative death. Death during cervical spine surgery is a very rare complication. In our multicenter study, there was a 0% mortality rate. Using an adequate surgical approach for patient diagnosis and comorbidities may be the reason how the occurrence of this catastrophic adverse event was prevented in our patient population.

  4. Chest radiographic data acquisition and quality assurance in multicenter studies

    International Nuclear Information System (INIS)

    Cleveland, R.H.; Schluchter, M.; Easley, K.A.; Wood, B.P.; Berdon, W.E.; Boechat, M.I.; Meziane, M.; Mellins, R.B.; Norton, K.I.; Singleton, E.; Trautwein, L.

    1997-01-01

    Background. Multicenter studies rely on data derived from different institutions. Forms can be designed to standardize the reporting process allowing reliable comparison of data. Objective. The purpose of the report is to provide a standardized method, developed as a part of a multicenter study of vertically transmitted HIV, for assessing chest radiographic results. Materials and methods. Eight hundred and five infants and children were studied at five centers; 3057 chest radiographs were scored. Data were entered using a forced-choice, graded response for 12 findings. Quality assurance measures and inter-rater agreement statistics are reported. Results. The form used for reporting chest radiographic results is presented. Inter-rater agreement was moderate to high for most findings, with the best correlation reported for the presence of bronchovascular markings and/or reticular densities addressed as a composite question (kappa = 0.71). The presence of nodular densities (kappa 0.56) and parenchymal consolidation (kappa = 0.57) had moderate agreement. Agreement for lung volume was low. Conclusion. The current tool, developed for use in the pediatric population, is applicable to any study involving the assessment of pediatric chest radiographs for a large population, whether at one or many centers. (orig.)

  5. Islet transplantation in multicenter networks: the GRAGIL example

    International Nuclear Information System (INIS)

    Thierry Berney; Pierre-Yves Benhamou; Laurence Kessler; Philippe Morel

    2006-01-01

    Purpose of review: The enthusiasm generated by the results of the Edmonton protocol of islet transplantation is inciting a great number of institutions to start such programs. However, the procedure of islet isolation and purification is costly, complex and technically challenging. In order to share costs and to avoid facing the steep learning curve of the procedure, many centers interested in islet transplantation have looked into collaborating with experienced groups serving as core islet isolation facilities. Recent findings: The proof of principle that remote islet processing and shipment could be successfully implemented with obtainng the Portland/Minneapolis, Huddinge/Giessen and Houston/Miami partnerships. Moreover, in order to increase both the donor pool and the number of patients gaining access to islet transplantation, multicenter networks, such as the Swiss-French GRAGIL consortium and the 4-country Nordic Network in Scandinavia have been built. The GRAGIL group has been fully operational since 1999, allowing the transplantation of 27 islet preparations processed in Geneva, Switzerland into 20 recipients in France over the course of 4.5 years. Organizational issues in the design of such networks are discussed based on the example of the GRAGIL experience. Summary: The feasibility and the efficiency of islet transplantation in multicenter networks have been demonstrated. This strategy allows to increase the donor pool and the accessibility to islet transplantation in an extended population area. (authors)

  6. Tritium-labelled abscisic acid

    International Nuclear Information System (INIS)

    Pluciennik, H.; Michalski, L.

    1991-01-01

    A simple method for the preparation of biologically active abscisic acid (growth inhibiting plant hormone) labelled with tritium is described. The product obtained has a specific radioactivity of 1.12 GBq mmol -1 : the yield is about 60% as compared to the initial amount of the substance used. (author) 7 refs.; 2 figs

  7. On Labeled Traveling Salesman Problems

    DEFF Research Database (Denmark)

    Couetoux, Basile; Gourves, Laurent; Monnot, Jerome

    2008-01-01

    We consider labeled Traveling Salesman Problems, defined upon a complete graph of n vertices with colored edges. The objective is to find a tour of maximum (or minimum) number of colors. We derive results regarding hardness of approximation, and analyze approximation algorithms for both versions ...

  8. Synthesis of labelled ecdysone precursors

    International Nuclear Information System (INIS)

    Haag, T.; Hetru, C.; Nakatani, Y.; Luu, B.; Meister, M.; Pichat, L.; Audinot, M.

    1985-01-01

    High specific activity tritiated 3β,14α-dihydroxy-5β-cholest-7-en-6-one, has been prepared using a precursor which permits rapid and easy labelling. This compound is converted to ecdysone under in vitro conditions by insect prothoracic glands, a well known site of ecdysone biosynthesis. (author)

  9. Two new French quality labels

    Energy Technology Data Exchange (ETDEWEB)

    Bresler, Ines

    2012-07-01

    'Origine France Garantie' and 'AQPV' are the new product labels that were presented in France in 2011. While the first is aimed at the entire industry, the latter is an effort to strengthen the PV industry. By raising the enthusiasm for local products, the French government hopes to keep the flood of foreign imports at bay. (orig.)

  10. Rock Music Gets a Label.

    Science.gov (United States)

    Cutietta, Robert

    1986-01-01

    A group called Parents Music Resource Center (PMRC) has captured the media spotlight with a proposal to have warning labels placed on music albums containing sexually explicit or violent lyrics. Major record companies have agreed to a version of the PMRC's demands for a one-year trial period, beginning in 1986. (RM)

  11. Improving the energy labelling scheme

    DEFF Research Database (Denmark)

    Gram-Hanssen, Kirsten; Christensen, Toke Haunstrup

    This report summarises the main results of an EU project on consumer response to energy labels in buildings. This report is mainly directed at Danish policy makers. The main focus is therefore on results that are relevant from a Danish point of view and on how they can be used to further strengthen...

  12. Psychological effectiveness of carbon labelling

    Science.gov (United States)

    Beattie, Geoffrey

    2012-04-01

    Despite the decision by supermarket-giant Tesco to delay its plan to add carbon-footprint information onto all of its 70,000 products, carbon labelling, if carefully designed, could yet change consumer behaviour. However, it requires a new type of thinking about consumers and much additional work.

  13. When Diagnostic Labels Mask Trauma

    Science.gov (United States)

    Foltz, Robert; Dang, Sidney; Daniels, Brian; Doyle, Hillary; McFee, Scott; Quisenberry, Carolyn

    2013-01-01

    A growing body of research shows that many seriously troubled children and adolescents are reacting to adverse life experiences. Yet traditional diagnostic labels are based on checklists of surface symptoms. Distracted by disruptive behavior, the common response is to medicate, punish, or exclude rather than respond to needs of youth who have…

  14. Synthesis of positron labeled photoactive compounds: 18F labeled aryl azides for positron labeling of biochemical molecules

    International Nuclear Information System (INIS)

    Hashizume, Kazunari; Hashimoto, Naota; Miyake, Yoshihiro

    1995-01-01

    The authors have prepared various [ 18 F] fluorine labeled aryl azides as a novel photoactive compounds suitable for positron labeling of biochemical molecules. The introduction of fluorine substituents to aryl azides can be expected to have dramatic effects on their nature and reactivity toward photolysis. Positron labeled reagents for labeling proteins or peptides have recently attracted considerable attention due to their wide applicability in biochemistry and positron emission tomography (PET). Various labeled azide compounds are often used in biochemistry for radiolabeling biological molecules by photolysis, but there have been no reports on the preparation or use of fluorine-18 labeled azides. The authors now report a novel synthesis of 18 F-labeled aryl azides which will have wide application in the biochemistry and nuclear medicine as a means for 18 F-fluorine labeling for proteins, peptides, and nucleic acids. 2 tabs

  15. Labelling fashion magazine advertisements: Effectiveness of different label formats on social comparison and body dissatisfaction.

    Science.gov (United States)

    Tiggemann, Marika; Brown, Zoe

    2018-06-01

    The experiment investigated the impact on women's body dissatisfaction of different forms of label added to fashion magazine advertisements. Participants were 340 female undergraduate students who viewed 15 fashion advertisements containing a thin and attractive model. They were randomly allocated to one of five label conditions: no label, generic disclaimer label (indicating image had been digitally altered), consequence label (indicating that viewing images might make women feel bad about themselves), informational label (indicating the model in the advertisement was underweight), or a graphic label (picture of a paint brush). Although exposure to the fashion advertisements resulted in increased body dissatisfaction, there was no significant effect of label type on body dissatisfaction; no form of label demonstrated any ameliorating effect. In addition, the consequence and informational labels resulted in increased perceived realism and state appearance comparison. Yet more extensive research is required before the effective implementation of any form of label. Copyright © 2018 Elsevier Ltd. All rights reserved.

  16. Labelling schemes: From a consumer perspective

    DEFF Research Database (Denmark)

    Juhl, Hans Jørn; Stacey, Julia

    2000-01-01

    Labelling of food products attracts a lot of political attention these days. As a result of a number of food scandals, most European countries have acknowledged the need for more information and better protection of consumers. Labelling schemes are one way of informing and guiding consumers....... However, initiatives in relation to labelling schemes seldom take their point of departure in consumers' needs and expectations; and in many cases, the schemes are defined by the institutions guaranteeing the label. It is therefore interesting to study how consumers actually value labelling schemes....... A recent MAPP study has investigated the value consumers attach the Government-controlled labels 'Ø-mærket' and 'Den Blå Lup' and the private supermarket label 'Mesterhakket' when they purchase minced meat. The results reveal four consumer segments that use labelling schemes for food products very...

  17. Soil Fumigant Labels - Metam Sodium/Potassium

    Science.gov (United States)

    Search by EPA registration number, product name, or company; and follow the link to the Pesticide Product Label System (PPLS) for details. Updated labels include new safety requirements for buffer zones and related measures.

  18. How to Read a Nutrition Facts Label

    Medline Plus

    Full Text Available ... Answers (Q&A) Staying Safe Videos for Educators ... packaged foods come with a Nutrition Facts label. These labels have a lot of important information — on fat and calories, serving sizes, sodium content, ...

  19. How to Read a Nutrition Facts Label

    Medline Plus

    Full Text Available ... topic for: Parents Kids Teens Keeping Portions Under Control Figuring Out Food Labels Healthy Food Shopping If My Child Has Food Allergies, What Should I Look for When Reading Food Labels? ...

  20. How to Read a Nutrition Facts Label

    Medline Plus

    Full Text Available ... labels have a lot of important information — on fat and calories, serving sizes, sodium content, and more — but ... Out Food Labels Healthy Food Shopping If My Child Has Food Allergies, What Should I Look for ...

  1. Different approaches to labelling parasitoids using strontium

    NARCIS (Netherlands)

    Gu, H.; Wäckers, F.L.; Steindl, P.; Günther, D.; Dorn, S.

    2001-01-01

    Labelling parasitoids with trace elements is a potentially powerful technique for studying dispersal and trophic interactions in these usually small insects. Laboratory experiments were conducted to investigate the feasibility and efficiency of different methods for trace element labelling of the

  2. How to Read a Nutrition Facts Label

    Medline Plus

    Full Text Available ... site Sitio para adolescentes Body Mind Sexual Health Food & Fitness Diseases & Conditions Infections Drugs & Alcohol School & Jobs ... las etiquetas de datos nutricionales (video) Most packaged foods come with a Nutrition Facts label. These labels ...

  3. 21 CFR 357.280 - Professional labeling.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Professional labeling. 357.280 Section 357.280 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Drug Products § 357.280 Professional labeling. The labeling provided to health professionals (but not...

  4. 21 CFR 357.180 - Professional labeling.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Professional labeling. 357.180 Section 357.180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Products § 357.180 Professional labeling. The labeling provided to health professionals (but not to the...

  5. 21 CFR 333.280 - Professional labeling.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Professional labeling. 333.280 Section 333.280 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Drug Products § 333.280 Professional labeling. The labeling provided to health professionals (but not...

  6. Injective Labeled Oriented Trees are Aspherical

    OpenAIRE

    Harlander, Jens; Rosebrock, Stephan

    2012-01-01

    A labeled oriented tree is called injective if each generator occurs at most once as an edge label. We show that injective labeled oriented trees are aspherical. The proof relies on a new relative asphericity test based on a lemma of Stallings.

  7. Link Label Prediction in Signed Citation Network

    KAUST Repository

    Akujuobi, Uchenna Thankgod

    2016-01-01

    such as using regression, trust propagation and matrix factorization. These approaches have tried to solve the problem of link label prediction by using ideas from social theories, where most of them predict a single missing label given that labels of other

  8. Three rules suffice for good label placement

    NARCIS (Netherlands)

    Wagner, F.; Wolff, A.; Kapoor, V.; Strijk, T.

    2001-01-01

    The general label-placement problem consists in labeling a set of features (points, lines, regions) given a set of candidates (rectangles, circles, ellipses, irregularly shaped labels) for each feature. The problem arises when annotating classical cartographical maps, diagrams, or graph drawings.

  9. A combinatorial framework for map labeling

    NARCIS (Netherlands)

    Wagner, F.; Wolff, A.; Whitesides, S.

    1998-01-01

    The general map labeling problem consists in labeling a set of sites (points, lines, regions) given a set of candidates (rectangles, circles, ellipses, irregularly shaped labels) for each site. A map can be a classical cartographical map, a diagram, a graph or any other figure that needs to be

  10. Gluten-Free Labeling of Foods

    Science.gov (United States)

    ... issued a final rule defining “gluten-free” for food labeling, which will help consumers, especially those living with ... free” label on foods. Food Facts: Gluten and Food Labeling: FDA’s Regulation of “Gluten-Free” Claims Blog: A ...

  11. Obstacles to nutrition labeling in restaurants.

    Science.gov (United States)

    Almanza, B A; Nelson, D; Chai, S

    1997-02-01

    This study determined the major obstacles that foodservices face regarding nutrition labeling. Survey questionnaire was conducted in May 1994. In addition to demographic questions, the directors were asked questions addressing willingness, current practices, and perceived obstacles related to nutrition labeling. Sixty-eight research and development directors of the largest foodservice corporations as shown in Restaurants & Institutions magazine's list of the top 400 largest foodservices (July 1993). P tests were used to determine significance within a group for the number of foodservices that were currently using nutrition labeling, perceived impact of nutrition labeling on sales, and perceived responsibility to add nutrition labels. Regression analysis was used to determine the importance of factors on willingness to label. Response rate was 45.3%. Most companies were neutral about their willingness to use nutrition labeling. Two thirds of the respondents were not currently using nutrition labels. Only one third thought that it was the foodservice's responsibility to provide such information. Several companies perceived that nutrition labeling would have a potentially negative effect on annual sales volume. Major obstacles were identified as menu or personnel related, rather than cost related. Menu-related obstacles included too many menu variations, limited space on the menu for labeling, and loss of flexibility in changing the menu. Personnel-related obstacles included difficulty in training employees to implement nutrition labeling, and not enough time for foodservice personnel to implement nutrition labeling. Numerous opportunities will be created for dietetics professionals in helping foodservices overcome these menu- or personnel-related obstacles.

  12. Predictive labeling with dependency pairs using SAT

    NARCIS (Netherlands)

    Koprowski, A.; Middeldorp, A.; Pfenning, F.

    2007-01-01

    This paper combines predictive labeling with dependency pairs and reports on its implementation. Our starting point is the method of proving termination of rewrite systems using semantic labeling with infinite models in combination with lexicographic path orders. We replace semantic labeling with

  13. On the Lucky labeling of Graphs

    OpenAIRE

    Ahadi, Arash; Dehghan, Ali; Mollaahmadi, Esmael

    2010-01-01

    Suppose the vertices of a graph $G$ were labeled arbitrarily by positive integers, and let $Sum(v)$ denote the sum of labels over all neighbors of vertex $v$. A labeling is lucky if the function $Sum$ is a proper coloring of $G$, that is, if we have $Sum(u) \

  14. 27 CFR 19.604 - Caution label.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Caution label. 19.604... OF THE TREASURY LIQUORS DISTILLED SPIRITS PLANTS Containers and Marks Marks § 19.604 Caution label... denaturer may be printed on such label, but no other extraneous matter will be permitted thereon without the...

  15. 47 CFR 15.19 - Labelling requirements.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Labelling requirements. 15.19 Section 15.19 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL RADIO FREQUENCY DEVICES General § 15.19 Labelling... label shall be located in a conspicuous location on the device and shall contain the unique...

  16. 27 CFR 26.39 - Labels.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Labels. 26.39 Section 26.39 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE... United States From Puerto Rico § 26.39 Labels. All labels affixed to bottles of liquors coming into the...

  17. 27 CFR 18.55 - Label.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Label. 18.55 Section 18.55... TREASURY LIQUORS PRODUCTION OF VOLATILE FRUIT-FLAVOR CONCENTRATE Operations § 18.55 Label. Each container of concentrate will have affixed thereto, before transfer, a label identifying the product and...

  18. 27 CFR 19.704 - Labels.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Labels. 19.704 Section 19... TREASURY LIQUORS DISTILLED SPIRITS PLANTS Samples of Spirits § 19.704 Labels. (a) On each container of spirits to be withdrawn under the provisions of § 19.701, the proprietor shall affix a label showing the...

  19. 46 CFR 188.10-37 - Label.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false Label. 188.10-37 Section 188.10-37 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OCEANOGRAPHIC RESEARCH VESSELS GENERAL PROVISIONS Definition of Terms Used in This Subchapter § 188.10-37 Label. This term means the label required by 49 CFR part 172...

  20. 21 CFR 820.120 - Device labeling.

    Science.gov (United States)

    2010-04-01

    ... designed to prevent mixups. (d) Labeling operations. Each manufacturer shall control labeling and packaging... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Device labeling. 820.120 Section 820.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES...

  1. What determines consumer attention to nutrition labels?

    NARCIS (Netherlands)

    Bialkova, S.E.; Trijp, van J.C.M.

    2010-01-01

    To identify the key determinants of consumer attention to nutrition labels, visual search tasks (present – absent; one – two targets) were used as an effective experimental tool. The main manipulation concerned: set size (number of labels on front of pack); label characteristics (display size,

  2. Evaluation of a multi-atlas based method for segmentation of cardiac CTA data: a large-scale, multicenter, and multivendor study

    International Nuclear Information System (INIS)

    Kirisli, H. A.; Schaap, M.; Klein, S.; Papadopoulou, S. L.; Bonardi, M.; Chen, C. H.; Weustink, A. C.; Mollet, N. R.; Vonken, E. J.; Geest, R. J. van der; Walsum, T. van; Niessen, W. J.

    2010-01-01

    Purpose: Computed tomography angiography (CTA) is increasingly used for the diagnosis of coronary artery disease (CAD). However, CTA is not commonly used for the assessment of ventricular and atrial function, although functional information extracted from CTA data is expected to improve the diagnostic value of the examination. In clinical practice, the extraction of ventricular and atrial functional information, such as stroke volume and ejection fraction, requires accurate delineation of cardiac chambers. In this paper, we investigated the accuracy and robustness of cardiac chamber delineation using a multiatlas based segmentation method on multicenter and multivendor CTA data. Methods: A fully automatic multiatlas based method for segmenting the whole heart (i.e., the outer surface of the pericardium) and cardiac chambers from CTA data is presented and evaluated. In the segmentation approach, eight atlas images are registered to a new patient's CTA scan. The eight corresponding manually labeled images are then propagated and combined using a per voxel majority voting procedure, to obtain a cardiac segmentation. Results: The method was evaluated on a multicenter/multivendor database, consisting of (1) a set of 1380 Siemens scans from 795 patients and (2) a set of 60 multivendor scans (Siemens, Philips, and GE) from different patients, acquired in six different institutions worldwide. A leave-one-out 3D quantitative validation was carried out on the eight atlas images; we obtained a mean surface-to-surface error of 0.94±1.12 mm and an average Dice coefficient of 0.93 was achieved. A 2D quantitative evaluation was performed on the 60 multivendor data sets. Here, we observed a mean surface-to-surface error of 1.26±1.25 mm and an average Dice coefficient of 0.91 was achieved. In addition to this quantitative evaluation, a large-scale 2D and 3D qualitative evaluation was performed on 1380 and 140 images, respectively. Experts evaluated that 49% of the 1380 images

  3. Synthesis of isotopically labeled ketamine

    OpenAIRE

    Stuchlíková, Lucie

    2011-01-01

    In this work were synthesized ketamine isotopomers. Ketamine is used in human medicine and veterinary sectors. It has very broad spectrum of pharmacological effects: anesthetic, analgesic, hallucinogenic, bronchodilator, cardiovascular and antidepressive, which is currently in the research. At first was synthesized precursor of ketamine, N- desmethylketamine which was subsequently labeled the deuterium, tritium and carbon- 14. For the determination of purity and identity mass spectrometry and...

  4. Radioactively labelled vitamin B12

    Energy Technology Data Exchange (ETDEWEB)

    Charlton, J C; Lewis, A

    1976-12-01

    A method is described for preparing radioactively labelled vitamin B 12 (cyanocobalamin) by reacting ..cap alpha..-(5,6-dimethylbenzimidazolyl) hydrogenobamide with active (sup(57,58)Co) cobaltous ion. The latter may be in the form of cobaltous chloride or sulphate in aqueous or aqueous alcoholic medium. The reaction is effected by heating the reactants in darkness at pH 4 to 8. An excess of cyanide is added to convert the hydroxocobalamin formed to cyanocobalamin.

  5. Radioactively labelled vitamin B12

    International Nuclear Information System (INIS)

    Charlton, J.C.; Lewis, A.

    1976-01-01

    A method is described for preparing radioactively labelled vitamin B 12 (cyanocobalamin) by reacting α-(5,6-dimethylbenzimidazolyl) hydrogenobamide with active (sup(57,58)Co) cobaltous ion. The latter may be in the form of cobaltous chloride or sulphate in aqueous or aqueous alcoholic medium. The reaction is effected by heating the reactants in darkness at pH 4 to 8. An excess of cyanide is added to convert the hydroxocobalamin formed to cyanocobalamin. (U.K.)

  6. Menakar Label Fundamentalisme Untuk Muslim

    OpenAIRE

    Wibisono, Susilo

    2014-01-01

    This study was developed referring to the negative connotation in using the word “fundamentalism ” and its using as an individual or group label. The method used in this study were literature review using many literatures about Islam and fundamentalism in any perspectives. Based on psychology perspective, it said that fundamentalism is an individual psychological construct associated with beliefs and individual interpretation of something, such as ideology, nationality, and religion. Accordin...

  7. Synthesis of deuterium labelled ibuprofen

    International Nuclear Information System (INIS)

    Cappon, V.J.; Halstead, G.W.; Theis, D.L.

    1986-01-01

    The preparations of [ar- 2 H 4 ]-ibuprofen and [ar, 3,3,3- 2 H 7 ]-ibuprofen are described. The deuterium was incorporated into the aromatic ring of [ar- 2 H 4 ]-ibuprofen which is a metabolically stable position. [ar, 3,3,3- 2 H 7 ]-ibuprofen was synthesized by the same route using [ 2 H 3 ]-CH 3 I instead of CH 3 I for use as a GC/MS internal standard in stable isotope labelled bioavailability studies. (author)

  8. Pharmaceuticals labelled with stable isotopes

    International Nuclear Information System (INIS)

    Krumbiegel, P.

    1986-11-01

    The relatively new field of pharmaceuticals labelled with stable isotopes is reviewed. Scientific, juridical, and ethical questions are discussed concerning the application of these pharmaceuticals in human medicine. 13 C, 15 N, and 2 H are the stable isotopes mainly utilized in metabolic function tests. Methodical contributions are given to the application of 2 H, 13 C, and 15 N pharmaceuticals showing new aspects and different states of development in the field under discussion. (author)

  9. Nutrition marketing on food labels.

    Science.gov (United States)

    Colby, Sarah E; Johnson, LuAnn; Scheett, Angela; Hoverson, Bonita

    2010-01-01

    This research sought to determine how often nutrition marketing is used on labels of foods that are high in saturated fat, sodium, and/or sugar. All items packaged with food labels (N = 56,900) in all 6 grocery stores in Grand Forks, ND were surveyed. Marketing strategy, nutrient label information, if the product was fruit/or milk based, and target age. Frequency distributions were computed. Forty-nine percent of all products contained nutrition marketing and of those, 48% had both nutrition marketing and were high in saturated fat, sodium and/or sugar (11%, 17%, and 31% respectively). Seventy-one percent of products marketed to children had nutrition marketing. Of those, 59% were high in saturated fat, sodium and/or sugar content, with more than half being high in sugar. The most commonly used nutrition marketing statements were "good source of calcium", "reduced/low/fat free", and "food company's health symbol". Nutrition marketing is commonly used on products high in saturated fat, sodium and/or sugar and is more often used on products marketed toward children than products marketed toward adults. Current food industry symbols may not be helping consumers select foods low in saturated fat, sodium or sugar. Published by Elsevier Inc.

  10. Biomolecule labelling by 186 Re

    International Nuclear Information System (INIS)

    Lungu, Valeria Viorica; Mihailescu, Gabriela; Dumitrescu, Gabriela

    1998-01-01

    The aim of this study is to develop and improve the existing radiolabelling techniques of peptides and monoclonal antibodies with 186 Re and 188 Re as potential agents for cancer targeted radiotherapy. We selected the following methods and techniques for direct labelling of peptides and monoclonal antibody: 1. Prereduction of -S-S- bridges of biomolecule to sulfhydryls using reducing agents: ascorbic acid, cysteine, active hydrogen, 2,3 dimercaptopropanol. The prereduction reactions are controlled by massic ratios of reduction agents/biomolecule, pH, temperature and time of incubation; 2. Reduction of 186 Re O 4 - stannous chloride in acid and alkaline pH; 3. Coupling reaction of 186 Re (red) with the biomolecule controlled by the time and temperature of incubation, the influence of pH regarding the binding of 186 Re to the biomolecules. The quality control was effected by chromatography techniques (paper and elution gel chromatography) on labeled biomolecule before and after purification. The elution gel chromatography was spectrophotometricaly monitored at 280 nm. In the same time the radioactivity of samples was measured using a gamma counter. All the results confirm in vitro stability of labeled biomolecule. The biological evaluation studies regarding accumulation and biological affinity will be controlled by scintigraphy method. Biodistribution studies will be effected to Walker tumor bearing animals at 4 and 24 hours after injections. (authors)

  11. Isotopically labelled pyrimidines and purines

    International Nuclear Information System (INIS)

    Balaban, A.T.; Bally, I.

    1987-01-01

    Among the three diazines, pyrimidine is by far the most important one because its derivatives uracil, thymine and cytosine are constituents of the ubiquitous deoxynucleic acids (DNA) and ribonucleic acids (RNA). Other derivatives of pyrimidine without condensed rings include barbiturates, alloxan, orotic acid and thiamine or vitamin B 1 . From the polycyclic derivatives of pyrimidine such as pteridine, alloxazine, and purine, the latter, through its derivatives adenine and guanine complete the list of bases which occur in DNA and RNA: in addition, other purine derivatives such as hypoxanthine, xanthine, theobromine, theophylline, caffeine and uric acid are important natural products with biological activity. The paper presents methods for preparing isotopically labeled pyrimidines as well as purine derivatives. For convenience, the authors describe separately carbon-labeled with radioisotopes 11 C (T 1/2 = 20.3 min) and 14 C (T 1/2 = 5736 years) or the stable isotope 13 C (natural abundance 1.1%) and then hydrogen-labeled systems with the radioisotope 3 H ≡ T (T 1/2 = 12.346 years) or with the stable isotope 2 H ≡ D (natural abundance 0.015%). We do not separate stable from radioactive isotopes because the synthetic methods are identical for the same element; however, the introduction of hydrogen isotopes into organic molecules is often performed by reactions such as isotope exchange which cannot take place in the case of carbon isotopes

  12. Quality of life after neck dissection. Multicenter study

    International Nuclear Information System (INIS)

    Nibu, Ken-ichi; Onitsuka, Tetsuo; Kawabata, Kazuyoshi

    2010-01-01

    To assess the impact of modifications to radical neck dissection and radiotherapy on the postoperative quality of life, the study group 'Study on Standardization of Treatment for Lymph Node Metastasis of Head and Neck Cancer' performed a multicenter cross-sectional study using our self-administered neck dissection questionnaire and arm abduction test. While sparing levels IV and V improved most postoperative symptoms, such as stiffness and constriction of the neck were avoided as long as the sternocleidmastoid muscle (SCM) and the spinal accessory nerve were preserved. Resection of the SCM and spinal accessory nerve resulted in a drop shoulder and neck pain, respectively. Irradiation with a total dose of 50 Gy or more worsened stiffness of neck and shoulder. (author)

  13. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P

    2000-01-01

    , dialysis-related complications, dialysis-related expenses. RESULTS: The quality-of-life studies showed that significantly more time for work, family, and social activities was available to patients on APD compared to those on CAPD (p ...) treatment with respect to quality of life and clinical outcomes in relation to therapy costs. DESIGN: A prospective, randomized multicenter study. SETTING: Three Danish CAPD units. PATIENTS: Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included...... were assessed at baseline and after 6 months by the self-administered short-form SF-36 generic health survey questionnaire supplemented with disease- and treatment-specific questions. Therapy costs were compared by evaluating dialysis-related expenses. MAIN OUTCOME MEASURES: Quality-of-life parameters...

  14. Studies of kinematic elements in two multicenter sunspot groups

    International Nuclear Information System (INIS)

    Korobova, Z.B.

    1983-01-01

    Some features of kinematic elements (KE) in two multicenter sunspot groups were studied using Tashkent full-disc white light heliograms. KE and morphological elements do not reveal any relationship. A KE coincides with a unipolar or multipolar spot or with part of a spot. It may also contain an extended stream including several spots. Relation of KE to large-scale photospheric magnetic fields is less clear. The line of polarity reversal is, in most cases, the deviding line between two adjacent KE. At the same time, a KE can contain spots of both polarities. Sunspot trajectories in the leading polarity regions show the best similarity. Interactions of KE are greatly influenced by the meridional drift. (author)

  15. A national multicenter registration study. Omalizumb in children in Denmark

    DEFF Research Database (Denmark)

    Spangberg, Katrien; Jørgensen, Inger Merete; Agertoft, Lone

    Background: In Denmark, Omalizumab is approved to treat children with severe persistent allergic asthma older than 6 years of age. No systematic registration of the efficacy in the Danish child population according to asthma symptoms or of the efficacy on co-morbid allergic symptoms exists. Results...... from a pilot study show that a broad panel of outcome measures is necessary to evaluate the efficacy of Omalizumab treatment as no change in lung function could be demonstrated Aim: To provide a standardized systematic registration in order to create a database enrolling children with severe allergic...... asthma treated with Omalizumab. Method and study design: A national multicenter registration and follow-up study based on children with clinical persistent severe allergic asthma including both retrospective and prospective registration. Inclusion criteria: • 6-18 years of age. • Severe persistent...

  16. A multicenter evaluation of the Biotest legionella urinary antigen EIA

    DEFF Research Database (Denmark)

    Harrison, Timothy; Uldum, Søren; Alexiou-Daniel, Stella

    1998-01-01

    OBJECTIVES: To undertake a multicenter study to evaluate the Biotest legionella urinary antigen enzyme immunoassay (EIA) performance against those EIAs already in use in 14 European laboratories. METHODS: Each laboratory examined urine specimens from appropriate patients using both their current...... assay and the Biotest EIA. Each examined: a standard panel of 12 coded urine samples (distributed by Biotest); a panel of 10 coded urine samples provided as part of a European external quality assurance (EQA) scheme; urine samples from patients with proven legionnaires' disease (LD); urine samples from...... patients with pneumonia of microbiologically proven cause other than LD; and urine samples submitted for routine examination. Thus, the performance of the Biotest assay (in comparison with current EIAs), its specificity and utility, and the inter-laboratory agreement were assessed. RESULTS: Inter...

  17. Congenital cholesteatoma of mastoid origin: A multicenter case series

    Directory of Open Access Journals (Sweden)

    Čvorović Ljiljana

    2014-01-01

    Full Text Available Background/Aim. The mastoid is the rarest site for the onset of congenital cholesteatoma (CC. The symptoms are atypical and minimal. The aim of this multicenter retrospective descriptive study was to define this extremely rare condition and its clinical presentation, diagnosis and management. Methods. We analyzed data files for a 15- year period in 4 tertiary otology centers and discovered 6 patients with the diagnosis of CC of the mastoid. Results. The clinical presentation of CC varied from incidental findings in patient to patient with otogenic meningitis. The most common findings during surgical procedures were mastoid cortex erosion, sigmoid plate dehiscence, dural exposure and external canal wall destruction. Conclusion. CC of mastoid origin tends to occur in adult patients probably because of minimal symptoms and the delayed diagnosis. It can exist for years in a nonaggressive state and develop to giant sizes. In children it is almost incidentally diagnosed. Early imaging is necessary in order to prevent serious complication.

  18. Scintigraphy with In-111 labeled leukocytes

    International Nuclear Information System (INIS)

    Itoh, Kazuo; Tsukamoto, Eriko; Furudate, Masayori; Saito, Chihoko.

    1987-01-01

    With increasing necessity for In-111 labeled leukocyte scintigraphy (ILLS) as a routine examination, a problem of complicated labeling of leukocytes has arisen. In this study, simplified labeling of leukocytes was examined with respect to its ability to detect abscesses. Simplified labeling method yielded significantly satisfactory results for recovery and labeling rates of leukocytes, as compared with conventional recommended method. Therefore, ILLS by simplified technique was clinically applied in 58 patients with suppurative or non-suppurative diseases who gave informed consent. In an analysis of ILLS for detecting suppurative region, the sensitivity, specificity, and corrected specificity were found to be 81 %, 75 %, and 82 %, respectively. (Namekawa, K.)

  19. METHOD AND MODULE FOR OPTICAL SUBCARRIER LABELLING

    DEFF Research Database (Denmark)

    2004-01-01

    The present invention relates to optical labelling in WDM networks, in that it provides a method and a module to be used in subcarrier label generation and switching in network edge nodes and core switch nodes. The methods and modules are typically employed in Optical Subcarrier Multiplexing (OSCM......) transmitters. The payload and the label are encoded independently on optical carrier and subcarrier signals respectively, using electro-optical modulators. The invention applies single or double sideband carrier-suppressed modulation to generate subcarrier signals for encoding of the label. Thereby the payload...... encoded carrier signal and the label encoded subcarrier signal can be coupled directly without prior filtering....

  20. Protein labelling with stable isotopes: strategies

    International Nuclear Information System (INIS)

    Lirsac, P.N.; Gilles, N.; Jamin, N.; Toma, F.; Gabrielsen, O.; Boulain, J.C.; Menez, A.

    1994-01-01

    A protein labelling technique with stable isotopes has been developed at the CEA: a labelled complete medium has been developed, performing as well as the Luria medium, but differing from it because it contains not only free aminated acids and peptides, but also sugars (96% of D-glucopyrannose) and labelled nucleosides. These precursors are produced from a labelled photosynthetic micro-organisms biomass, obtained with micro-algae having incorporated carbon 13, nitrogen 15 and deuterium during their culture. Labelling costs are reduced. 1 fig., 1 tab., 3 refs

  1. The filtering, clear-cornea diathermal keratostomy: a minor Danish multicenter study

    DEFF Research Database (Denmark)

    Kessing, S.V.; Nissen, O.I.; Thygesen, J.

    2008-01-01

    PURPOSE: Is the new micropenetrating, clear-cornea procedure, intrastromal diathermal keratostomy (IDK), an alternative to the intricate "modern trabeculectomy"? METHODS: Prospective multicenter study. Four surgeons from 4 Danish eye departments attended an IDK course and subsequently decided whe...

  2. European multicenter analytical evaluation of the Abbott ARCHITECT STAT high sensitive troponin I immunoassay

    DEFF Research Database (Denmark)

    Krintus, Magdalena; Kozinski, Marek; Boudry, Pascal

    2014-01-01

    BACKGROUND: International recommendations highlight the superior value of cardiac troponins (cTns) for early diagnosis of myocardial infarction along with analytical requirements of improved precision and detectability. In this multicenter study, we investigated the analytical performance of a ne...

  3. Predicting behavioral variant frontotemporal dementia with pattern classification in multi-center structural MRI data

    Directory of Open Access Journals (Sweden)

    Sebastian Meyer

    2017-01-01

    Conclusion: Our study demonstrates that MRI, a widespread imaging technology, can individually identify bvFTD with high accuracy in multi-center imaging data, paving the road to personalized diagnostic approaches in the future.

  4. Spin labelling of human erythrocytes with nitroxide radicals

    International Nuclear Information System (INIS)

    Chagalj, C.; DePaoli, T.C.P.; Hager, A.A.; Palaoro, L.A.; Rubin de Celis, E.; Farach, H.A.; Poole, C.P. jr

    1984-01-01

    Human erythrocytes were labelled with nitroxide, the spin label SYNVAR 101, under various experimantal conditions. A study was made of the influence of antireductants on the labelling efficiency and the kinetics of the radical decay during the labelling process

  5. Research of private label development in Croatia

    Directory of Open Access Journals (Sweden)

    Sandra Horvat

    2009-07-01

    Full Text Available Private labels have been present on the market since 19th century but their intensive market growth began in the last thirty years after retailers realized what their potential could be in the fight against ever-growing competition. Their market growth has not been distributed equally thought the world so Europe became the region with the highest private label market share, which exceeds 40% on some markets. Although the private label market share in Croatia is considerably smaller, it has also increased steadily over the last decade since private labels were introduced on the market. This paper presents the findings of a research conducted for the purpose of identifying trends in private label development on the Croatian market. The research was conducted through in-depth interviews with private label managers in retail companies in Croatia, and with the managers responsible for private label production in manufacturing companies. The research identified three expected trends of private label development in Croatia and these are: an increase in private label quality, the maintenance of a price gap between private labels and manufacturers’ brands and a further increase in the private label market share.

  6. Multi-Center Electronic Structure Calculations for Plasma Equation of State

    Energy Technology Data Exchange (ETDEWEB)

    Wilson, B G; Johnson, D D; Alam, A

    2010-12-14

    We report on an approach for computing electronic structure utilizing solid-state multi-center scattering techniques, but generalized to finite temperatures to model plasmas. This approach has the advantage of handling mixtures at a fundamental level without the imposition of ad hoc continuum lowering models, and incorporates bonding and charge exchange, as well as multi-center effects in the calculation of the continuum density of states.

  7. Recurrent Laryngeal Nerve Palsy After Cervical Spine Surgery: A Multicenter AOSpine Clinical Research Network Study

    OpenAIRE

    Gokaslan, Ziya L.; Bydon, Mohamad; De la Garza-Ramos, Rafael; Smith, Zachary A.; Hsu, Wellington K.; Qureshi, Sheeraz A.; Cho, Samuel K.; Baird, Evan O.; Mroz, Thomas E.; Fehlings, Michael; Arnold, Paul M.; Riew, K. Daniel

    2017-01-01

    Study Design: Multicenter retrospective study. Objectives: To investigate the risk of symptomatic recurrent laryngeal nerve palsy (RLNP) following cervical spine surgery, to examine risk factors for its development, and to report its treatment and outcomes. Methods: A multicenter study from 21 high-volume surgical centers from the AOSpine North America Clinical Research Network was performed. Each center screened for rare complications following cervical spine surgery, including RLNP. Patient...

  8. Tritium labeling of detonation nanodiamonds.

    Science.gov (United States)

    Girard, Hugues A; El-Kharbachi, Abdelouahab; Garcia-Argote, Sébastien; Petit, Tristan; Bergonzo, Philippe; Rousseau, Bernard; Arnault, Jean-Charles

    2014-03-18

    For the first time, the radioactive labeling of detonation nanodiamonds was efficiently achieved using a tritium microwave plasma. According to our measurements, the total radioactivity reaches 9120 ± 120 μCi mg(-1), with 93% of (3)H atoms tightly bonded to the surface and up to 7% embedded into the diamond core. Such (3)H doping will ensure highly stable radiolabeled nanodiamonds, on which surface functionalization is still allowed. This breakthrough opens the way to biodistribution and pharmacokinetics studies of nanodiamonds, while this approach can be scalable to easily treat bulk quantities of nanodiamonds at low cost.

  9. Hemoglobin Labeled by Radioactive Lysine

    Science.gov (United States)

    Bale, W. F.; Yuile, C. L.; DeLaVergne, L.; Miller, L. L.; Whipple, G. H.

    1949-12-08

    This paper reports on the utilization of tagged epsilon carbon of DL-lysine by a dog both anemic and hypoproteinemic due to repeated bleeding plus a diet low in protein. The experiment extended over period of 234 days, a time sufficient to indicate an erythrocyte life span of at least 115 days based upon the rate of replacement of labeled red cell proteins. The proteins of broken down red cells seem not to be used with any great preference for the synthesis of new hemoglobin.

  10. Food nutrition labelling practice in China.

    Science.gov (United States)

    Tao, Yexuan; Li, Ji; Lo, Y Martin; Tang, Qingya; Wang, Youfa

    2011-03-01

    The present study aimed to scrutinize the food nutrition labelling practice in China before the Chinese Food Nutrition Labeling Regulation (CFNLR) era. Nutrition information of pre-packaged foods collected from a supermarket between December 2007 and January 2008 was analysed and compared with findings from a survey conducted in Beijing. Information collected from a supermarket in Shanghai. A total of 850 pre-packaged foods. In the Shanghai survey, the overall labelling rate was 30·9 %, similar to that found in the Beijing study (29·7 %). While only 20·5 % of the snacks in Shanghai had nutrition labelling, the percentage of food items labelled with SFA (8·6 %), trans fatty acid (4·7 %) or fibre (12·1 %) was very low. Of those food items with nutrition labels, a considerable proportion (7-15 %) did not label energy, fat, carbohydrate or protein. Food products manufactured by Taiwan and Hong Kong companies had a lower labelling rate (13·6 %) than those manufactured by domestic (31·6 %) or international manufacturers (33·8 %). The very low food nutrition labelling rate among products sold in large chain supermarkets in major cities of China before CFNLR emphasizes the need for such critical regulations to be implemented in order to reinforce industrial compliance with accurate nutrition labelling.

  11. Consumer knowledge and attitudes toward nutritional labels.

    Science.gov (United States)

    Cannoosamy, Komeela; Pugo-Gunsam, Prity; Jeewon, Rajesh

    2014-01-01

    To determine Mauritian consumers' attitudes toward nutritional labels based on the Kano model and to identify determinants of the use and understanding of nutrition labels. The researchers also used a Kano model questionnaire to determine consumers' attitudes toward nutrition labeling. Four hundred consumers residing in Mauritius. Information was elicited via a questionnaire that assessed nutritional knowledge and information about the use and understanding of nutritional labels and demographic factors. Nutritional label use and understanding, nutrition knowledge, and association of demographic factors with label use. Statistical tests performed included 1-way ANOVA and independent samples t tests. Statistically significant relationships (P nutritional knowledge and nutritional label usage with demographic factors. All demographic factors with the exception of gender were significantly associated (P nutritional label understanding. Based on the outcome of the Kano survey, calorie content, trans fat content, protein content, and cholesterol content were found to be must-be attributes: that is, attributes that, when not present, result in consumer dissatisfaction. Age, education, income, household size, and nutrition knowledge had an impact on nutritional label use. Health promoters should aim to increase the use of nutritional labels. Copyright © 2014 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

  12. Label Space Reduction in MPLS Networks: How Much Can A Single Stacked Label Do?

    DEFF Research Database (Denmark)

    Solano, Fernando; Stidsen, Thomas K.; Fabregat, Ramon

    2008-01-01

    Most network operators have considered reducing LSR label spaces (number of labels used) as a way of simplifying management of underlaying virtual private networks (VPNs) and therefore reducing operational expenditure (OPEX). The IETF outlined the label merging feature in MPLS-allowing the config......Most network operators have considered reducing LSR label spaces (number of labels used) as a way of simplifying management of underlaying virtual private networks (VPNs) and therefore reducing operational expenditure (OPEX). The IETF outlined the label merging feature in MPLS...

  13. Link Label Prediction in Signed Citation Network

    KAUST Repository

    Akujuobi, Uchenna

    2016-04-12

    Link label prediction is the problem of predicting the missing labels or signs of all the unlabeled edges in a network. For signed networks, these labels can either be positive or negative. In recent years, different algorithms have been proposed such as using regression, trust propagation and matrix factorization. These approaches have tried to solve the problem of link label prediction by using ideas from social theories, where most of them predict a single missing label given that labels of other edges are known. However, in most real-world social graphs, the number of labeled edges is usually less than that of unlabeled edges. Therefore, predicting a single edge label at a time would require multiple runs and is more computationally demanding. In this thesis, we look at link label prediction problem on a signed citation network with missing edge labels. Our citation network consists of papers from three major machine learning and data mining conferences together with their references, and edges showing the relationship between them. An edge in our network is labeled either positive (dataset relevant) if the reference is based on the dataset used in the paper or negative otherwise. We present three approaches to predict the missing labels. The first approach converts the label prediction problem into a standard classification problem. We then, generate a set of features for each edge and then adopt Support Vector Machines in solving the classification problem. For the second approach, we formalize the graph such that the edges are represented as nodes with links showing similarities between them. We then adopt a label propagation method to propagate the labels on known nodes to those with unknown labels. In the third approach, we adopt a PageRank approach where we rank the nodes according to the number of incoming positive and negative edges, after which we set a threshold. Based on the ranks, we can infer an edge would be positive if it goes a node above the

  14. Multimodal label-free microscopy

    Directory of Open Access Journals (Sweden)

    Nicolas Pavillon

    2014-09-01

    Full Text Available This paper reviews the different multimodal applications based on a large extent of label-free imaging modalities, ranging from linear to nonlinear optics, while also including spectroscopic measurements. We put specific emphasis on multimodal measurements going across the usual boundaries between imaging modalities, whereas most multimodal platforms combine techniques based on similar light interactions or similar hardware implementations. In this review, we limit the scope to focus on applications for biology such as live cells or tissues, since by their nature of being alive or fragile, we are often not free to take liberties with the image acquisition times and are forced to gather the maximum amount of information possible at one time. For such samples, imaging by a given label-free method usually presents a challenge in obtaining sufficient optical signal or is limited in terms of the types of observable targets. Multimodal imaging is then particularly attractive for these samples in order to maximize the amount of measured information. While multimodal imaging is always useful in the sense of acquiring additional information from additional modes, at times it is possible to attain information that could not be discovered using any single mode alone, which is the essence of the progress that is possible using a multimodal approach.

  15. Labeled receptor ligands for spect

    International Nuclear Information System (INIS)

    Kung, H.F.

    1989-01-01

    Receptor specific imaging agents for single photon emission computed tomography (SPECT) can potentially be useful in the understanding of basic biochemistry and pharmacology of receptors. SPECT images may also provide tools for evaluation of density and binding kinetics of a specific receptor, information important for diagnosis and patient management. Basic requirements for receptor imaging agents are: (a) they are labeled with short-lived isotopes, (b) they show high selectivity and specific uptake, (c) they exhibit high target/background ratio, and (d) they can be modeled to obtain quantitative information. Several good examples of CNS receptor specific ligands labeled with I-123 have been developed, including iodoQNB, iodoestrogen iodobenzadiazepine, iodobenazepine, iodobenzamides for muscarinic, estrogen benzadiazepine, D-1 and D-2 dopamine receptors. With the advent of newer and faster SPECT imaging devices, it may be feasible to quantitate the receptor density by in vivo imaging techniques. These new brain imaging agents can provide unique diagnostic information, which may not be available through other imaging modalities, such as CT and MRI

  16. Refractory obstetrical antiphospholipid syndrome: Features, treatment and outcome in a European multicenter retrospective study.

    Science.gov (United States)

    Mekinian, Arsène; Alijotas-Reig, Jaume; Carrat, Fabrice; Costedoat-Chalumeau, Nathalie; Ruffatti, Amelia; Lazzaroni, Maria Grazia; Tabacco, Sara; Maina, Aldo; Masseau, Agathe; Morel, Nathalie; Esteve-Valverde, Enrique Esteve; Ferrer-Oliveras, Raquel; Andreoli, Laura; De Carolis, Sara; Josselin-Mahr, Laurence; Abisror, Noémie; Nicaise-Roland, Pascale; Tincani, Angela; Fain, Olivier

    2017-07-01

    To describe the consecutive pregnancy outcome and treatment in refractory obstetrical antiphospholipid syndrome (APS). Retrospective multicenter open-labelled study from December 2015 to June 2016. We analyzed the outcome of pregnancies in patients with obstetrical APS (Sydney criteria) and previous adverse obstetrical event despite low-dose aspirin and low-molecular weight heparin LMWH (LMWH) conventional treatment who experienced at least one subsequent pregnancy. Forty nine patients with median age 27years (23-32) were included from 8 European centers. Obstetrical APS was present in 71%, while 26% had obstetrical and thrombotic APS. Lupus anticoagulant was present in 76% and triple antiphospholipid antibody (APL) positivity in 45% of patients. Pregnancy loss was noted in 71% with a median age of gestation of 11 (8-21) weeks. The presence of APS non-criteria features (35% vs 17% in pregnancies without adverse obstetrical event; p=0.09), previous intrauterine death (65% vs 38%; p=0.06), of LA (90% vs 65%; p=0.05) were more frequent in pregnancies with adverse pregnancy outcome, whereas isolated recurrent miscarriage profile was more frequent in pregnancies without any adverse pregnancy outcome (15% vs 41%; p=0.04). In univariate analysis considering all pregnancies (index and subsequent ones), an history of previous intrauterine death was associated with pregnancy loss (odds-ratio 2.51 (95% CI 1.274.96); p=0.008), whereas previous history of prematurity related to APS (odds-ratio 0.13 95%CI 0.04 0.41, P=0.006), steroids use during the pregnancy (odds-ratio 0.30 95% CI 0.11-0.82, p=0.019) and anticardiolipids isolated profile (odds-ratio 0.51 95% CI 0.26-1.03, p=0.0588) were associated with favorable outcome. In multivariate analysis, only previous history of prematurity, steroids use and anticardiolipids isolated profiles were associated with live-birth pregnancy. The main features of refractory obstetrical APS were the high rates of LA and triple APL positivity

  17. A multicenter, randomized controlled trial of individualized occupational therapy for patients with schizophrenia in Japan.

    Science.gov (United States)

    Shimada, Takeshi; Ohori, Manami; Inagaki, Yusuke; Shimooka, Yuko; Sugimura, Naoya; Ishihara, Ikuyo; Yoshida, Tomotaka; Kobayashi, Masayoshi

    2018-01-01

    The individualized occupational therapy (IOT) program is a psychosocial program that we developed to facilitate proactive participation in treatment and improve cognitive functioning and other outcomes for inpatients with acute schizophrenia. The program consists of motivational interviewing, self-monitoring, individualized visits, handicraft activities, individualized psychoeducation, and discharge planning. This multicenter, open-labeled, blinded-endpoint, randomized controlled trial evaluated the impact of adding IOT to a group OT (GOT) program as usual for outcomes in recently hospitalized patients with schizophrenia in Japanese psychiatric hospitals setting compared with GOT alone. Patients with schizophrenia were randomly assigned to the GOT+IOT group or the GOT alone group. Among 136 randomized patients, 129 were included in the intent-to-treat population: 66 in the GOT+IOT and 63 in the GOT alone groups. Outcomes were administered at baseline and discharge or 3 months following hospitalization including the Brief Assessment of Cognition in Schizophrenia Japanese version (BACS-J), the Schizophrenia Cognition Rating Scale Japanese version, the Social Functioning Scale Japanese version, the Global Assessment of Functioning scale, the Intrinsic Motivation Inventory Japanese version (IMI-J), the Morisky Medication Adherence Scale-8 (MMAS-8), the Positive and Negative Syndrome Scale (PANSS), and the Japanese version of Client Satisfaction Questionnaire-8 (CSQ-8J). Results of linear mixed effects models indicated that the IOT+GOT showed significant improvements in verbal memory (p <0.01), working memory (p = 0.02), verbal fluency (p < 0.01), attention (p < 0.01), and composite score (p < 0.01) on the BACS-J; interest/enjoyment (p < 0.01), value/usefulness (p < 0.01), perceived choice (p < 0.01), and IMI-J total (p < 0.01) on the IMI-J; MMAS-8 score (p < 0.01) compared with the GOT alone. Patients in the GOT+IOT demonstrated significant improvements on the CSQ-8J

  18. Automated cell counts on CSF samples: A multicenter performance evaluation of the GloCyte system.

    Science.gov (United States)

    Hod, E A; Brugnara, C; Pilichowska, M; Sandhaus, L M; Luu, H S; Forest, S K; Netterwald, J C; Reynafarje, G M; Kratz, A

    2018-02-01

    Automated cell counters have replaced manual enumeration of cells in blood and most body fluids. However, due to the unreliability of automated methods at very low cell counts, most laboratories continue to perform labor-intensive manual counts on many or all cerebrospinal fluid (CSF) samples. This multicenter clinical trial investigated if the GloCyte System (Advanced Instruments, Norwood, MA), a recently FDA-approved automated cell counter, which concentrates and enumerates red blood cells (RBCs) and total nucleated cells (TNCs), is sufficiently accurate and precise at very low cell counts to replace all manual CSF counts. The GloCyte System concentrates CSF and stains RBCs with fluorochrome-labeled antibodies and TNCs with nucleic acid dyes. RBCs and TNCs are then counted by digital image analysis. Residual adult and pediatric CSF samples obtained for clinical analysis at five different medical centers were used for the study. Cell counts were performed by the manual hemocytometer method and with the GloCyte System following the same protocol at all sites. The limits of the blank, detection, and quantitation, as well as precision and accuracy of the GloCyte, were determined. The GloCyte detected as few as 1 TNC/μL and 1 RBC/μL, and reliably counted as low as 3 TNCs/μL and 2 RBCs/μL. The total coefficient of variation was less than 20%. Comparison with cell counts obtained with a hemocytometer showed good correlation (>97%) between the GloCyte and the hemocytometer, including at very low cell counts. The GloCyte instrument is a precise, accurate, and stable system to obtain red cell and nucleated cell counts in CSF samples. It allows for the automated enumeration of even very low cell numbers, which is crucial for CSF analysis. These results suggest that GloCyte is an acceptable alternative to the manual method for all CSF samples, including those with normal cell counts. © 2017 John Wiley & Sons Ltd.

  19. Surgical site infections in Italian Hospitals: a prospective multicenter study

    Directory of Open Access Journals (Sweden)

    Ippolito Giuseppe

    2008-03-01

    Full Text Available Abstract Background Surgical site infections (SSI remain a major clinical problem in terms of morbidity, mortality, and hospital costs. Nearly 60% of SSI diagnosis occur in the postdischarge period. However, literature provides little information on risk factors associated to in-hospital and postdischarge SSI occurrence. A national prospective multicenter study was conducted with the aim of assessing the incidence of both in-hospital and postdisharge SSI, and the associated risk factors. Methods In 2002, a one-month, prospective national multicenter surveillance study was conducted in General and Gynecological units of 48 Italian hospitals. Case ascertainment of SSI was carried out using standardized surveillance methodology. To assess potential risk factors for SSI we used a conditional logistic regression model. We also reported the odds ratios of in-hospital and postdischarge SSI. Results SSI occurred in 241 (5.2% of 4,665 patients, of which 148 (61.4% during in-hospital, and 93 (38.6% during postdischarge period. Of 93 postdischarge SSI, sixty-two (66.7% and 31 (33.3% were detected through telephone interview and questionnaire survey, respectively. Higher SSI incidence rates were observed in colon surgery (18.9%, gastric surgery (13.6%, and appendectomy (8.6%. If considering risk factors for SSI, at multivariate analysis we found that emergency interventions, NNIS risk score, pre-operative hospital stay, and use of drains were significantly associated with SSI occurrence. Moreover, risk factors for total SSI were also associated to in-hospital SSI. Additionally, only NNIS, pre-operative hospital stay, use of drains, and antibiotic prophylaxis were associated with postdischarge SSI. Conclusion Our study provided information on risk factors for SSI in a large population in general surgery setting in Italy. Standardized postdischarge surveillance detected 38.6% of all SSI. We also compared risk factors for in-hospital and postdischarge SSI

  20. Economic Impact of Dengue: Multicenter Study across Four Brazilian Regions

    Science.gov (United States)

    Martelli, Celina Maria Turchi; Siqueira, Joao Bosco; Parente, Mirian Perpetua Palha Dias; Zara, Ana Laura de Sene Amancio; Oliveira, Consuelo Silva; Braga, Cynthia; Pimenta, Fabiano Geraldo; Cortes, Fanny; Lopez, Juan Guillermo; Bahia, Luciana Ribeiro; Mendes, Marcia Costa Ooteman; da Rosa, Michelle Quarti Machado; de Siqueira Filha, Noemia Teixeira; Constenla, Dagna; de Souza, Wayner Vieira

    2015-01-01

    Background Dengue is an increasing public health concern in Brazil. There is a need for an updated evaluation of the economic impact of dengue within the country. We undertook this multicenter study to evaluate the economic burden of dengue in Brazil. Methods We estimated the economic burden of dengue in Brazil for the years 2009 to 2013 and for the epidemic season of August 2012- September 2013. We conducted a multicenter cohort study across four endemic regions: Midwest, Goiania; Southeast, Belo Horizonte and Rio de Janeiro; Northeast: Teresina and Recife; and the North, Belem. Ambulatory or hospitalized cases with suspected or laboratory-confirmed dengue treated in both the private and public sectors were recruited. Interviews were scheduled for the convalescent period to ascertain characteristics of the dengue episode, date of first symptoms/signs and recovery, use of medical services, work/school absence, household spending (out-of-pocket expense) and income lost using a questionnaire developed for a previous cost study. We also extracted data from the patients’ medical records for hospitalized cases. Overall costs per case and cumulative costs were calculated from the public payer and societal perspectives. National cost estimations took into account cases reported in the official notification system (SINAN) with adjustment for underreporting of cases. We applied a probabilistic sensitivity analysis using Monte Carlo simulations with 90% certainty levels (CL). Results We screened 2,223 cases, of which 2,035 (91.5%) symptomatic dengue cases were included in our study. The estimated cost for dengue for the epidemic season (2012–2013) in the societal perspective was US$ 468 million (90% CL: 349–590) or US$ 1,212 million (90% CL: 904–1,526) after adjusting for under-reporting. Considering the time series of dengue (2009–2013) the estimated cost of dengue varied from US$ 371 million (2009) to US$ 1,228 million (2013). Conclusions The economic burden

  1. Report of a Brazilian multicenter study on nephropathic cystinosis.

    Science.gov (United States)

    Vaisbich, Maria Helena; Koch, Vera H

    2010-01-01

    The Brazilian Multicenter Nephropathic Study Group, founded in 1999, is currently composed of 16 pediatric nephrology units, which are coordinated by the Pediatric Nephrology Unit of Instituto da Criança--HCFMUSP. This Study Group intends to better know our patients, their special characteristics and facilitates the treatment. To present an update on the demographics of the ongoing study participants with interest on renal function status, response to therapy, and extra-renal complications. Patient recruitment to the study is based on informed consent and has been supported by the Brazilian Society of Nephrology, by the creation of an electronic homepage and by the participation in medical meetings and publications in medical periodicals. Our study protocol involves the initial and follow-up questionnaire, the measurement of intraleukocyte cystine content, initiation and follow-up therapy with cysteamine, and clinical patient follow-up based on a protocol of subsidiary exams. We identified 102 patients (42 females) with nephropathic cystinosis in Brazil since 1999. Forty-six children are followed at the Instituto da Criança/SP, 15 at the Hospital Pequeno Príncipe/PR, 12 at the UNICAMP/SP, 10 at the Unidade de Transplante Renal - HCFMUSP/SP and 3 at the Santa Casa/SP; the remaining patients are followed at the Instituto da Criança and at their respective doctors' offices in different nephrology services in Brazil. Of these patients, 23/102 (22.5%) have normal renal function, 19/102 (18.6%) are in chronic renal failure with conservative treatment, 26/102 are on dialysis (18 on peritoneal dialysis and 8 on hemodialysis), and 34/102 received a renal transplant. The extra-renal involvement diagnosed was: hypothyroidism in 63 patients, diabetes mellitus in 8 patients, muscular involvement in 7 patients, a compromised central nervous system in 5 patients, hepatic complications in 5 patients, and deglutition dysfunction in 2 patients. During this period, 10

  2. Labeling of the spent fuel waste package

    International Nuclear Information System (INIS)

    Culbreth, W.G.; Chagari, A.K.

    1992-01-01

    This paper reports that the containers used to store spent fuel in an underground repository must meet federal guidelines that call for unique labels that identify the contents and processing history. Existing standards in the nuclear power industry and relevant ASME/ANSI codes have been reviewed for possible application to the spent-fuel container labeling. An Array of labeling techniques were found that include recommendations for: fonts, word spacing, color combinations, label materials and mounting methods, placement, and content. The use of bar code, optical character recognition, and RF labels were also studied to meet the requirement that the container labels be consistent with the methods used to maintain the repository records

  3. Radiopharmaceutical potential of I-131 labelled diazepam

    International Nuclear Information System (INIS)

    Yurt, F.; Unek, P.; Asikoglu, M.; Baggi, S.; Erener, G.; Ozkilic, H.; Uluc, F.; Tuglular, I.

    1998-01-01

    In this study, diazepam is a derivative of the 1.4 benzodiazepine family that the most widely used drug as anticonvulsant agent has been labeled with I-131, as a new radiopharmaceutical and its radiopharmaceutical potential has been determined. Labeling of diazepam has been performed by iodogen method and optimum labeling conditions have been determined. Optimum reaction conditions are 1 mg for iodogen amount; 1-5 mg for diazepam amount, 15-20 minutes for reaction time and room temperature for reaction temperature. Specific activity of labeled compound was 0,15 Ci/mmol level. N-octanol/water ratio was found 1.9 for 131 IDZ ( 131 I labeled diazepam). In vivo experiments have been carried out to determine radiopharmaceutical potentials of labeled compound. Biodistribution studies on rats showed that 131 IDZ have accumulated in kidneys, liver, lungs and brain tissues. Scintigraphic results taken with gamma camera on rabbits agree with biodistribution results of rats. (author)

  4. Green power: naturemade - History of a label

    International Nuclear Information System (INIS)

    Lainsecq, M. de

    2003-01-01

    This article presents the history of the set of 'naturemade' labels that are used to designate power generated in facilities that use renewable energy. Electricity from hydropower, wind-power, biogas and solar energy plants that fulfil particular ecological conditions receives a special label, 'Naturemade Star'. 'Normal' hydropower can be awarded the 'Naturemade Basic' label. The development of the labels is discussed in the light of increasing liberalisation of European electricity markets and increasing sales of 'green power' by electricity utilities. The need for certification of production facilities and the founding of the label's certification authority, the 'Verein fuer umweltgerechte Elektrizitaet' (VUE), a society for the promotion of environment-friendly electricity, are discussed. Criticisms made by certain environmental protection organisations on the awarding of the 'Naturemade Basic' label to projects that in their opinion do not help protect the environment are quoted. The article is completed with an interview on the subject with Ursula Stocker from the VUE

  5. Chemoenzymatic synthesis of carbon-14 labelled antioxidants

    International Nuclear Information System (INIS)

    Deigner, H.P.; Freyberg, C.; Heck, R.

    1993-01-01

    The syntheses of [ 14 C] labelled antioxidants are described. We developed an efficient synthetic methodology to prepare a series of labelled amides with antioxidant activity, starting from [ 14 C] KCN and alkyl or aryl halides. By a combination of nucleophilic displacement of halides by [ 14 C] cyanide, mediated by ultrasound and subsequent mild and selective enzymatic hydrolysis of the resulting nitriles, labelled carboxylic acids were obtained. Labelled amines were prepared by reduction of the respective nitriles. Availability of [ 14 C] KCN, efficient introduction of the label by ultrasound mediated reaction and selective and mild hydrolysis by commercially available nitrilase (Rhodococcus sp.), makes possible a wide range of applications of this methodology in the synthesis of functionalized labelled compounds. (Author)

  6. Prevention of ICU delirium and delirium-related outcome with haloperidol: a study protocol for a multicenter randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Delirium is a frequent disorder in intensive care unit (ICU) patients with serious consequences. Therefore, preventive treatment for delirium may be beneficial. Worldwide, haloperidol is the first choice for pharmacological treatment of delirious patients. In daily clinical practice, a lower dose is sometimes used as prophylaxis. Some studies have shown the beneficial effects of prophylactic haloperidol on delirium incidence as well as on mortality, but evidence for effectiveness in ICU patients is limited. The primary objective of our study is to determine the effect of haloperidol prophylaxis on 28-day survival. Secondary objectives include the incidence of delirium and delirium-related outcome and the side effects of haloperidol prophylaxis. Methods This will be a multicenter three-armed randomized, double-blind, placebo-controlled, prophylactic intervention study in critically ill patients. We will include consecutive non-neurological ICU patients, aged ≥18 years with an expected ICU length of stay >1 day. To be able to demonstrate a 15% increase in 28-day survival time with a power of 80% and alpha of 0.05 in both intervention groups, a total of 2,145 patients will be randomized; 715 in each group. The anticipated mortality rate in the placebo group is 12%. The intervention groups will receive prophylactic treatment with intravenous haloperidol 1 mg/q8h or 2 mg/q8h, and patients in the control group will receive placebo (sodium chloride 0.9%), both for a maximum period of 28-days. In patients who develop delirium, study medication will be stopped and patients will subsequently receive open label treatment with a higher (therapeutic) dose of haloperidol. We will use descriptive summary statistics as well as Cox proportional hazard regression analyses, adjusted for covariates. Discussion This will be the first large-scale multicenter randomized controlled prevention study with haloperidol in ICU patients with a high risk of delirium, adequately

  7. Functional alterations of human platelets following indium-111 labelling using different incubation media and labelling agents

    International Nuclear Information System (INIS)

    Isaka, Yoshinari; Imaizumi, Masatoshi; Kimura, Kazufumi; Matsumoto, Masayasu; Kamada, Takenobu

    1991-01-01

    Human platelets were labelled in the absence of presence of plasma using 111 In-labelled oxine sulphate, tropolone or 2-mercaptopyridine-N-oxide (MPO). Under in vitro and in vivo conditions, platelet functions were evaluated by measuring their aggregability, survival, recovery and early distribution. High labelling efficiency was achieved in saline labelling, whereas with plasma labelling, it was necessary to concentrate the platelet-rich plasma to 4.8x10 6 platelets/μl. The aggregation of platelets labelled in plasma or saline was compared with that of controls; platelets labelled in saline showed lower aggregability in 2 μM ADP but not in 5 μM ADP nor with collagen. No significant differences in platelet survival and recovery were noted between platelets labelled in plasma and those labelled in saline. Our results indicate that partial loss of ADP aggregability in vitro does not influence the in vivo viability of platelets labelled in saline. Scintigraphic studies showed that platelets labelled in a saline medium were temporarily sequestrated in the liver but not in the spleen or heart. Thus, platelet labelling in saline does not affect platelet function adversely, but platelets labelled in plasma are more desirable for assessing the early distribution of platelets in the reticuloendothelial system. (orig.)

  8. ML-MG: Multi-label Learning with Missing Labels Using a Mixed Graph

    KAUST Repository

    Wu, Baoyuan

    2015-12-07

    This work focuses on the problem of multi-label learning with missing labels (MLML), which aims to label each test instance with multiple class labels given training instances that have an incomplete/partial set of these labels (i.e. some of their labels are missing). To handle missing labels, we propose a unified model of label dependencies by constructing a mixed graph, which jointly incorporates (i) instance-level similarity and class co-occurrence as undirected edges and (ii) semantic label hierarchy as directed edges. Unlike most MLML methods, We formulate this learning problem transductively as a convex quadratic matrix optimization problem that encourages training label consistency and encodes both types of label dependencies (i.e. undirected and directed edges) using quadratic terms and hard linear constraints. The alternating direction method of multipliers (ADMM) can be used to exactly and efficiently solve this problem. To evaluate our proposed method, we consider two popular applications (image and video annotation), where the label hierarchy can be derived from Wordnet. Experimental results show that our method achieves a significant improvement over state-of-the-art methods in performance and robustness to missing labels.

  9. Synthesis of carboxy-labelled 1-carnitine

    International Nuclear Information System (INIS)

    Goodfellow, D.B.; Hoppel, C.L.; Turkaly, J.S.

    1982-01-01

    A method for the production of carboxy-labelled l-carnitine is described. The first step is the chemical synthesis of 4-N-trimethylammoniobutanoate (butyrobetaine) from the precursors 4-aminobutanoate and iodomethane. The second step involves the hydroxylation of butyrobetaine to form l-carnitine using butyrobetaine hydroxylase partially purified from bovine calf liver. The method also can be used to synthesize Me-labelled and uniformly-chain-labelled l-carnitine. (author)

  10. Conducting multicenter research in healthcare simulation: Lessons learned from the INSPIRE network.

    Science.gov (United States)

    Cheng, Adam; Kessler, David; Mackinnon, Ralph; Chang, Todd P; Nadkarni, Vinay M; Hunt, Elizabeth A; Duval-Arnould, Jordan; Lin, Yiqun; Pusic, Martin; Auerbach, Marc

    2017-01-01

    Simulation-based research has grown substantially over the past two decades; however, relatively few published simulation studies are multicenter in nature. Multicenter research confers many distinct advantages over single-center studies, including larger sample sizes for more generalizable findings, sharing resources amongst collaborative sites, and promoting networking. Well-executed multicenter studies are more likely to improve provider performance and/or have a positive impact on patient outcomes. In this manuscript, we offer a step-by-step guide to conducting multicenter, simulation-based research based upon our collective experience with the International Network for Simulation-based Pediatric Innovation, Research and Education (INSPIRE). Like multicenter clinical research, simulation-based multicenter research can be divided into four distinct phases. Each phase has specific differences when applied to simulation research: (1) Planning phase , to define the research question, systematically review the literature, identify outcome measures, and conduct pilot studies to ensure feasibility and estimate power; (2) Project Development phase , when the primary investigator identifies collaborators, develops the protocol and research operations manual, prepares grant applications, obtains ethical approval and executes subsite contracts, registers the study in a clinical trial registry, forms a manuscript oversight committee, and conducts feasibility testing and data validation at each site; (3) Study Execution phase , involving recruitment and enrollment of subjects, clear communication and decision-making, quality assurance measures and data abstraction, validation, and analysis; and (4) Dissemination phase , where the research team shares results via conference presentations, publications, traditional media, social media, and implements strategies for translating results to practice. With this manuscript, we provide a guide to conducting quantitative multicenter

  11. Eye tracking and nutrition label use

    DEFF Research Database (Denmark)

    Graham, Dan J.; Orquin, Jacob Lund; Visschers, Vivianne H.M.

    2012-01-01

    cameras monitoring consumer visual attention (i.e., eye tracking) has begun to identify ways in which label design could be modified to improve consumers’ ability to locate and effectively utilize nutrition information. The present paper reviews all published studies of nutrition label use that have...... utilized eye tracking methodology, identifies directions for further research in this growing field, and makes research-based recommendations for ways in which labels could be modified to improve consumers’ ability to use nutrition labels to select healthful foods....

  12. [Academic production on food labeling in Brazil].

    Science.gov (United States)

    Câmara, Maria Clara Coelho; Marinho, Carmem Luisa Cabral; Guilam, Maria Cristina; Braga, Ana Maria Cheble Bahia

    2008-01-01

    To review and discuss academic production (theses and dissertations) on the topic of labeling of prepackaged foods in Brazil. A search of the database maintained by the Coordination for the Development of Higher Education Professionals (CAPES), one of the two Brazilian government research funding and support agencies, was conducted on the following keywords: "rotulagem" (labeling), "rotulagem nutricional" (food labeling) and "rótulo de alimentos" (food labels). The search covered the years 1987 (earliest year available) to 2004. We identified 49 studies on this topic. Content analysis identified three major themes: the extent to which food labels meet specific legal requirements (57.2%); the degree to which consumers understand the information on labels (22.4%); and the labeling of transgenic or genetically-modified foods (20.4%). Food labeling is a frequent topic and is adequately covered by the Brazilian academic production. In most of the studies, ineffective law enforcement appears to be the main factor in the lack of compliance with and disrespect for the food labeling rules and regulations in Brazil.

  13. 40 CFR 86.1606 - Labeling.

    Science.gov (United States)

    2010-07-01

    ... Emission Control Information Update; (2) Full corporate name and trademark of the vehicle manufactuer; (3... tuneup specifications (if changed from the original label specifications) at the applicable altitude. ...

  14. 75 FR 21007 - Food Labeling; Public Workshop

    Science.gov (United States)

    2010-04-22

    ..., particularly small businesses, with firsthand working knowledge of FDA's requirements and compliance policies... Consumer Protection Act of 2004, (3) nutrition labeling requirements, (4) health and nutrition claims, and...

  15. Labelled antibiotics as tumour-localizing agents

    International Nuclear Information System (INIS)

    Taylor, D.M.; McCready, V.R.

    1976-01-01

    The published results of clinical and experimental studies of labelled bleomycins and tetracyclines are reviewed. None of the labelled antibiotics yet studied show anything approaching absolute tumour specificity. Clinical trials suggest that 57 Co-bleomycin is superior to either 111 In- or 99 Tcsup(m)-bleomycin and that it may possess some advantages over 67 Ga-citrate in respect of lower uptake in the abdomen and, possibly, lower uptakes in benign and inflammatory lesions. Radioiodine-labelled or 99 Tcsup(m)-labelled tetracyclines appear to be of little value in tumour localization. (author)

  16. Labeling schemes for bounded degree graphs

    DEFF Research Database (Denmark)

    Adjiashvili, David; Rotbart, Noy Galil

    2014-01-01

    We investigate adjacency labeling schemes for graphs of bounded degree Δ = O(1). In particular, we present an optimal (up to an additive constant) log n + O(1) adjacency labeling scheme for bounded degree trees. The latter scheme is derived from a labeling scheme for bounded degree outerplanar...... graphs. Our results complement a similar bound recently obtained for bounded depth trees [Fraigniaud and Korman, SODA 2010], and may provide new insights for closing the long standing gap for adjacency in trees [Alstrup and Rauhe, FOCS 2002]. We also provide improved labeling schemes for bounded degree...

  17. Multicenter Clinical Trial of Keratin Biomaterial for Peripheral Nerve Regeneration

    Science.gov (United States)

    2015-12-01

    ship rat carcasses to inviCRO for autoradiography analysis. The last animal was euthanized today at time point Day 30.  April 6, 2015: Sectioning...of rat carcasses by inviCRO to start later in the week. The animals had no abnormalities detected by clinical observation throughout the duration of...Approximately 0.08 ml of the labeled hydrogel was implanted intramuscularly in the quadriceps muscle. The animal care and use protocol developed at

  18. Chronic gastritis in China: a national multi-center survey.

    Science.gov (United States)

    Du, Yiqi; Bai, Yu; Xie, Pei; Fang, Jingyuan; Wang, Xiaozhong; Hou, Xiaohua; Tian, Dean; Wang, Chengdang; Liu, Yandi; Sha, Weihong; Wang, Bangmao; Li, Yanqing; Zhang, Guoliang; Li, Yan; Shi, Ruihua; Xu, Jianming; Li, Youming; Huang, Minghe; Han, Shengxi; Liu, Jie; Ren, Xu; Xie, Pengyan; Wang, Zhangliu; Cui, Lihong; Sheng, Jianqiu; Luo, Hesheng; Wang, Zhaohui; Zhao, Xiaoyan; Dai, Ning; Nie, Yuqiang; Zou, Yiyou; Xia, Bing; Fan, Zhining; Chen, Zhitan; Lin, Sanren; Li, Zhao-Shen

    2014-02-07

    Chronic gastritis is one of the most common findings at upper endoscopy in the general population, and chronic atrophic gastritis is epidemiologically associated with the occurrence of gastric cancer. However, the current status of diagnosis and treatment of chronic gastritis in China is unclear. A multi-center national study was performed; all patients who underwent diagnostic upper endoscopy for evaluation of gastrointestinal symptoms from 33 centers were enrolled. Data including sex, age, symptoms and endoscopic findings were prospectively recorded. Totally 8892 patients were included. At endoscopy, 4389, 3760 and 1573 patients were diagnosed to have superficial gastritis, erosive gastritis, and atrophic gastritis, respectively. After pathologic examination, it is found that atrophic gastritis, intestinal metaplasia and dysplasia were prevalent, which accounted for 25.8%, 23.6% and 7.3% of this patient population. Endoscopic features were useful for predicting pathologic atrophy (PLR = 4.78), but it was not useful for predicting erosive gastritis. Mucosal-protective agents and PPI were most commonly used medications for chronic gastritis. The present study suggests non-atrophic gastritis is the most common endoscopic finding in Chinese patients with upper GI symptoms. Precancerous lesions, including atrophy, intestinal metaplasia and dysplasia are prevalent in Chinese patients with chronic gastritis, and endoscopic features are useful for predicting pathologic atrophy.

  19. Chronic gastritis in China: a national multi-center survey

    Science.gov (United States)

    2014-01-01

    Background Chronic gastritis is one of the most common findings at upper endoscopy in the general population, and chronic atrophic gastritis is epidemiologically associated with the occurrence of gastric cancer. However, the current status of diagnosis and treatment of chronic gastritis in China is unclear. Methods A multi-center national study was performed; all patients who underwent diagnostic upper endoscopy for evaluation of gastrointestinal symptoms from 33 centers were enrolled. Data including sex, age, symptoms and endoscopic findings were prospectively recorded. Results Totally 8892 patients were included. At endoscopy, 4389, 3760 and 1573 patients were diagnosed to have superficial gastritis, erosive gastritis, and atrophic gastritis, respectively. After pathologic examination, it is found that atrophic gastritis, intestinal metaplasia and dysplasia were prevalent, which accounted for 25.8%, 23.6% and 7.3% of this patient population. Endoscopic features were useful for predicting pathologic atrophy (PLR = 4.78), but it was not useful for predicting erosive gastritis. Mucosal-protective agents and PPI were most commonly used medications for chronic gastritis. Conclusions The present study suggests non-atrophic gastritis is the most common endoscopic finding in Chinese patients with upper GI symptoms. Precancerous lesions, including atrophy, intestinal metaplasia and dysplasia are prevalent in Chinese patients with chronic gastritis, and endoscopic features are useful for predicting pathologic atrophy. PMID:24502423

  20. Oral cancer in the UAE: a multicenter, retrospective study

    Science.gov (United States)

    Anis, Raeefa; Gaballah, Kamis

    2013-01-01

    Aim To determine the prevalence of various malignant oral lesions in the UAE and correlate cases of squamous cell carcinomas with age, gender, site, grade, clinical presentations at the time of diagnosis, and the prevalence of neck metastasis. Materials and methods A multicenter, retrospective study was conducted at four major hospitals in the UAE. The study was based on histopathology reports of biopsies of oral tissues. Results Of the 992 oral biopsy reports retrieved, 147 cases of malignant tumors were found which accounted for 14.9% of the total biopsies. Fifteen different types of malignant lesions were diagnosed, of which oral squamous cell carcinoma (OSCC) was the most prevalent and made up 11.4% of the overall oral biopsies retrieved. The commonest presentation of cancer was ulceration (31.17%), followed by lumps and white lesions. The most common site where the lesions were diagnosed was the tongue (51.9%), followed by the cheeks and lips. OSCC accounted for 77% of all malignancies reported. Neck dissections were conducted in only 20.8% of all OSCC cases diagnosed at Mafraq and Tawam hospitals, of which 43.75% showed evidence of neck metastasis. Conclusion Oral cancer is not an uncommon disease in the UAE. This may mandate more awareness campaigning, including screening procedures for early detection of cancerous lesions and other potentially malignant oral diseases. Elective neck dissections to detect lymph node metastasis should be more routinely performed, in particular for tongue carcinomas because of the early neck involvement potential. PMID:23985381

  1. Multicenter evaluation of an enzymatic method for glycated albumin.

    Science.gov (United States)

    Paleari, Renata; Bonetti, Graziella; Callà, Cinzia; Carta, Mariarosa; Ceriotti, Ferruccio; Di Gaetano, Nicola; Ferri, Marilisa; Guerra, Elena; Lavalle, Gabriella; Cascio, Claudia Lo; Martino, Francesca Gabriela; Montagnana, Martina; Moretti, Marco; Santini, Gabriele; Scribano, Donata; Testa, Roberto; Vero, Anna; Mosca, Andrea

    2017-06-01

    The use of glycated albumin (GA) has been proposed as an additional glycemic control marker particularly useful in intermediate-term monitoring and in situation when HbA 1c test is not reliable. We have performed the first multicenter evaluation of the analytical performance of the enzymatic method quantILab Glycated Albumin assay implemented on the most widely used clinical chemistry analyzers (i.e. Abbott Architect C8000, Beckman Coulter AU 480 and 680, Roche Cobas C6000, Siemens ADVIA 2400 and 2400 XPT). The repeatability of the GA measurement (expressed as CV, %) implemented in the participating centers ranged between 0.9% and 1.2%. The within-laboratory CVs ranged between 1.2% and 1.6%. A good alignment between laboratories was found, with correlation coefficients from 0.996 to 0.998. Linearity was confirmed in the range from 7.6 to 84.7%. The new enzymatic method for glycated albumin evaluated by our investigation is suitable for clinical use. Copyright © 2017 Elsevier B.V. All rights reserved.

  2. [Motivations for a consultation before adoption: A multicenter study].

    Science.gov (United States)

    Thieblemont, M; Francois, P; Poirier, V; Bosdure, E; Munck, M-R; Borsa-Dorion, A; Hazart, I; Moukagni-Pelzer, M; Brunel, D; Peyron, F; de Monleon, J-V

    2016-01-01

    While the number of international adoptions in France is decreasing, adopted children are older and in poorer health than they used to be. This phenomenon has resulted in an increase in the demand for preadoption consultations over the past several years. This study analyses the reasons for these consultations. Prospective multicenter study conducted from 1 January to 31 December 2013. Ten centers contributed to the study, i.e., 196 preadoption consultations. Seeking medical advice was the reason for 88% of the consultations, whether the advice was based on the study of an identified child's medical file (32%) or a country's healthcare characteristics, whether the country was identified (34%) or not (23%). In 6% of cases, the motive for preadoption consultations was social and familial, and in the last 5% it was to obtain general information about adoption and its procedures. In more than 40% of the cases, whether the child or the country identified, Russia is the subject of the consultation because of the complexity of the files and because of the dreaded but rarely mentioned fetal alcohol syndrome. The deterioration of adopted children's health is an additional worry for future adoption applicants. To provide them with the best information possible without making choices for them, specialists should have substantial experience in adoption before going into these preadoption consultations. Copyright © 2015. Published by Elsevier SAS.

  3. Bronchiectasis diagnosed after renal transplantation: a retrospective multicenter study.

    Science.gov (United States)

    Dury, Sandra; Colosio, Charlotte; Etienne, Isabelle; Anglicheau, Dany; Merieau, Elodie; Caillard, Sophie; Rivalan, Joseph; Thervet, Eric; Essig, Marie; Babinet, François; Subra, Jean-François; Toubas, Olivier; Rieu, Philippe; Launois, Claire; Perotin-Collard, Jeanne-Marie; Lebargy, François; Deslée, Gaëtan

    2015-11-07

    Bronchiectasis is characterized by abnormal, permanent and irreversible dilatation of the bronchi, usually responsible for daily symptoms and frequent respiratory complications. Many causes have been identified, but only limited data are available concerning the association between bronchiectasis and renal transplantation. We conducted a retrospective multicenter study of cases of bronchiectasis diagnosed after renal transplantation in 14 renal transplantation departments (French SPIESSER group). Demographic, clinical, laboratory and CT scan data were collected. Forty-six patients were included (mean age 58.2 years, 52.2 % men). Autosomal dominant polycystic kidney disease (32.6 %) was the main underlying renal disease. Chronic cough and sputum (50.0 %) were the major symptoms leading to chest CT scan. Mean duration of symptoms before diagnosis was 1.5 years [0-12.1 years]. Microorganisms were identified in 22 patients, predominantly Haemophilus influenzae. Hypogammaglobulinemia was observed in 46.9 % patients. Bronchiectasis was usually extensive (84.8 %). The total bronchiectasis score was 7.4 ± 5.5 with a significant gradient from apex to bases. Many patients remained symptomatic (43.5 %) and/or presented recurrent respiratory tract infections (37.0 %) during follow-up. Six deaths (13 %) occurred during follow-up, but none were attributable to bronchiectasis. These results highlight that the diagnosis of bronchiectasis should be considered in patients with de novo respiratory symptoms after renal transplantation. Further studies are needed to more clearly understand the mechanisms underlying bronchiectasis in this setting.

  4. Evaluation of fluorine-18-labeled alkylating agents as potential synthons for the labeling of oligonucleotides

    NARCIS (Netherlands)

    de Vries, EFJ; Vroegh, J; Elsinga, PH; Vaalburg, W

    Six fluorine-18-labeled alkylating agents were selected as potentially suitable synthons for the labeling of antisense oligonucleotides. The selected synthons were evaluated in a model reaction with the monomer adenosine 5'-O-thiomonophosphate. Of these synthons,

  5. Label Review Training: Module 2: Parts of the Label, Page 10

    Science.gov (United States)

    This module of the label review training describes the parts of the front and back panel of the pesticide label. You will learn what kinds of information each part includes, as well as how to organize these parts.

  6. Label Review Training: Module 2: Parts of the Label, Page 9

    Science.gov (United States)

    This module of the label review training describes the parts of the front and back panel of the pesticide label. You will learn what kinds of information each part includes, as well as how to organize these parts.

  7. Label Review Training: Module 2: Parts of the Label, Page 8

    Science.gov (United States)

    This module of the label review training describes the parts of the front and back panel of the pesticide label. You will learn what kinds of information each part includes, as well as how to organize these parts.

  8. Label Review Training: Module 2: Parts of the Label, Page 16

    Science.gov (United States)

    This module of the label review training describes the parts of the front and back panel of the pesticide label. You will learn what kinds of information each part includes, as well as how to organize these parts.

  9. Label Review Training: Module 2: Parts of the Label, Page 12

    Science.gov (United States)

    This module of the label review training describes the parts of the front and back panel of the pesticide label. You will learn what kinds of information each part includes, as well as how to organize these parts.

  10. Label Review Training: Module 2: Parts of the Label, Page 2

    Science.gov (United States)

    This module of the label review training describes the parts of the front and back panel of the pesticide label. You will learn what kinds of information each part includes, as well as how to organize these parts.

  11. Label Review Training: Module 2: Parts of the Label, Page 6

    Science.gov (United States)

    This module of the label review training describes the parts of the front and back panel of the pesticide label. You will learn what kinds of information each part includes, as well as how to organize these parts.

  12. Label Review Training: Module 2: Parts of the Label, Page 1

    Science.gov (United States)

    This module of the label review training describes the parts of the front and back panel of the pesticide label. You will learn what kinds of information each part includes, as well as how to organize these parts.

  13. Label Review Training: Module 2: Parts of the Label, Page 14

    Science.gov (United States)

    This module of the label review training describes the parts of the front and back panel of the pesticide label. You will learn what kinds of information each part includes, as well as how to organize these parts.

  14. Label Review Training: Module 2: Parts of the Label, Page 13

    Science.gov (United States)

    This module of the label review training describes the parts of the front and back panel of the pesticide label. You will learn what kinds of information each part includes, as well as how to organize these parts.

  15. Label Review Training: Module 2: Parts of the Label, Page 3

    Science.gov (United States)

    This module of the label review training describes the parts of the front and back panel of the pesticide label. You will learn what kinds of information each part includes, as well as how to organize these parts.

  16. Label Review Training: Module 2: Parts of the Label, Page 11

    Science.gov (United States)

    This module of the label review training describes the parts of the front and back panel of the pesticide label. You will learn what kinds of information each part includes, as well as how to organize these parts.

  17. Label Review Training: Module 2: Parts of the Label, Page 4

    Science.gov (United States)

    This module of the label review training describes the parts of the front and back panel of the pesticide label. You will learn what kinds of information each part includes, as well as how to organize these parts.

  18. Label Review Training: Module 2: Parts of the Label, Page 5

    Science.gov (United States)

    This module of the label review training describes the parts of the front and back panel of the pesticide label. You will learn what kinds of information each part includes, as well as how to organize these parts.

  19. Label Review Training: Module 2: Parts of the Label, Page 7

    Science.gov (United States)

    This module of the label review training describes the parts of the front and back panel of the pesticide label. You will learn what kinds of information each part includes, as well as how to organize these parts.

  20. Tritium labelled steroids, preparation process and application to synthesis of tritium labelled estrane derivatives

    International Nuclear Information System (INIS)

    1978-01-01

    Process for preparing new steroids labelled with tritium in 6.7 and comprising in 3 a blocked ketonic group as ketal, thioketal or derivatives. Application of these products to the synthesis of tritium labelled estrane derivatives [fr

  1. 16 CFR Appendix L to Part 305 - Sample Labels

    Science.gov (United States)

    2010-01-01

    ... DISCLOSURES REGARDING ENERGY CONSUMPTION AND WATER USE OF CERTAIN HOME APPLIANCES AND OTHER PRODUCTS REQUIRED... Part 305—Sample Labels ER29AU07.122 PROTOTYPE LABEL 1 ER29AU07.123 PROTOTYPE LABEL 2 ER29AU07.124 PROTOTYPE LABEL 3 ER29AU07.125 PROTOTYPE LABEL 4 ER29AU07.126 SAMPLE LABEL 1 ER29AU07.127 SAMPLE LABEL 2...

  2. Scintigraphy with /sup 111/In-labeled leukocytes. Simplified procedure for labeling

    Energy Technology Data Exchange (ETDEWEB)

    Terada, Hitoshi; Shiire, Yasushi; Koizumi, Kiyoshi; Aburano, Tamio; Tonami, Norihisa; Hisada, Kin-ichi

    1987-12-01

    To utilize /sup 111/In leukocytes in a routine work, simplified procedure for sterile leukocytes preparation and labeling with water soluble oxine sulfate was performed. Viability and chemotaxis of leukocytes were maintained during separation and labeling. Chelated rate of /sup 111/In with oxine sulfate was 93.5 %. Labeling efficiency of /sup 111/In leukocytes was 93.8 %. Obvious blood pool images due to remaind erythrocytes were not observed. /sup 111/In labeled leukocytes showed good migration into inflammatory focci.

  3. Synthesis and labelling of epidepride

    International Nuclear Information System (INIS)

    Yang Min; Pei Zhuguo; Hu Mingyang; Wang Bocheng; Zhou Xingqin

    2001-01-01

    S-(-)-N-[(1-ethyl-2-pyrrolidinyl) methyl]-5-iodo-2,3-dimethoxybenzamide (proposed generic name, epidepride) is a very potent dopamine D2 antagonist. It was synthesized by five steps from 3-methoxysalicylic acid. [ 131 I]epidepride was obtained in 97.3% radiochemical yields from the corresponding 5-(tributyltin) derivative using hydrogen peroxide as the oxidant. The aryltin precursor was prepared from non-labelled epidepride by palladium-catalyzed stannylene using bis (tri-n-butyltin) in triethylamine. [ 131 I] epidepride was stable under 4 degree C, and partition coefficient was 72.3 at pH 7.40. The biodistribution study in rats exhibited high localization in the striatum of the brain with the striatum/cerebellum ratio reaching 237/1 at 320 min postinjection. All these results suggest that [ 131 I] epidepride may be used widely as a useful dopamine D2 receptor imaging agent for SPECT

  4. Chain store management through private labels strategy

    Directory of Open Access Journals (Sweden)

    Martina Sopta

    2007-07-01

    Full Text Available The purpose of this paper is to examine the market shares of private labels in the European Union and on the global market, and to compare the results of the analysis with the level of presence of private labels on the Croatian market. Moreover, through the application of macro and microeconomic tools, the author tried to estimate the future trends of private labels in Croatia.For the purpose of the paper secondary and primary data was used in the research. Relevant scientific and professional literature of local and foreign authors was analyzed. In addition, a few recent research studies were analyzed and their results compared. Field research has been conducted by the survey method, with 225 respondents included in the intentional sample.The main hypothesis of the paper based on research is that, in total sales, private labels are gaining a growing share in all markets, regardless of the development level of those markets. Alongside the main hypothesis of the work, three supporting hypotheses were tested to see which private labels are a good alternative to other brands on the world market. Private labels are generally developed on generic products. The third supporting hypothesis starts from the assumption that the investments in the promotion of private labels are negligible, resulting in lower prices of thoseproducts. The results of research and analyses in the work indicate that the position of private labels will strengthen internationally, as part of the process of liberalization and globalization of trade flows. In the process of purchase of private labels the positioning of the point of sale and price have an increasing contribution. With the concentration of commerce in chain stores, the share of private labels grows, approaching a half of the total sales in some countries. Considering the Croatian market, according to the international product life cycle theory, the share of private labels in the total sales will grow in the future

  5. Leukemic cell labeling with indium-111-oxine

    International Nuclear Information System (INIS)

    Uchida, T.; Takagi, Y.; Matsuda, S.; Yui, T.; Ishibashi, T.; Kimura, H.; Kariyone, S.

    1984-01-01

    Leukemic cells were labeled with In-111-oxine in patients with acute leukemia. In vitro labeling studies revealed that labeling efficiency reached maximum 80.8 +- 3.6% (mean +- 1SD) by 2 times washes after 20 minutes incubation time. Cell viability was assessed by trypan blue exclusion test and in vitro culture of leukemic cells, which showed no cellular damage during labeling procedure. Elution of In-111 from the labeled cells was 10.0 +- 1.2% at 12 hours after labeling. For in vivo leukemic cell kinetic studies, more than 10/sup 8/ leukemic cells separated from Ficoll-Hypacque sedimentation were labeled by 30 minutes of In-111-oxine incubation and two times washes at 37 0 C. In vivo studies were performed in 7 patients with acute myeloblastic, lymphoblastic leukemia and blastic crisis of chronic myelocytic leukemia. Labeled leukemic cells disappeared in single exponential fashion with half life of 9.6 to 31.8 hours. Total leukemic cell pool in peripheral circulation was calculated, which correlated well with peripheral leukemic cell counts (r=0.99). No relationship was observed between total leukemic cell pool and leukemic cell turnover rate. Migration patterns of labeled leukemic cells showed that pulmonary uptake was evident within 15 minutes after the infusion and returned to base-line. Splenic and hepatic uptake showed gradual increase up to 24 hours. Bone marrow accumulation was shown only in 2 cases. Presently, there are no suitable radionuclides for leukemic cell labeling. In-111-oxine labeled leukemic cells would overcome this difficulty

  6. Portion Size Labeling and Intended Soft Drink Consumption: The Impact of Labeling Format and Size Portfolio

    Science.gov (United States)

    Vermeer, Willemijn M.; Steenhuis, Ingrid H. M.; Leeuwis, Franca H.; Bos, Arjan E. R.; de Boer, Michiel; Seidell, Jacob C.

    2010-01-01

    Objective: To assess what portion size labeling "format" is most promising in helping consumers selecting appropriate soft drink sizes, and whether labeling impact depends on the size portfolio. Methods: An experimental study was conducted in fast-food restaurants in which 2 labeling formats (ie, reference portion size and small/medium/large…

  7. Approaches to facilitate institutional review board approval of multicenter research studies.

    Science.gov (United States)

    Marsolo, Keith

    2012-07-01

    Gaining Institutional Review Board (IRB) approval for a multicenter research study can be a lengthy and time-consuming process. It can increase the complexity of consent forms, decreasing patient understanding and lowering recruitment numbers. It also leads to increased costs through the duplication of effort. This paper examines some of the strategies used to streamline the IRB review process for multicenter studies and provides examples used by 2 existing multicenter comparative effectiveness research networks. A literature search was conducted to identify sources that described the challenges and potential strategies to facilitate multicenter IRB approval. The most promising avenues were identified and included in this review. Phone interviews were conducted with the Principal Investigators and Project Managers of 2 successful multicenter research networks to learn their "keys to success" and their lessons learned. Three strategies were identified that held the most promise: working with IRBs before submission, the use of central and/or federated IRBs, and the establishment of an umbrella protocol. Each of these strategies was used to some degree by the case study projects. Although the approaches documented here can help streamline the IRB approval process, they are not a "silver bullet." Because some of these approaches are still relatively new, empirical data are sparse. However, it is believed that they will significantly reduce the administrative burden of the project as a whole and lead to a decrease in the overall time to protocol approval.

  8. Multi-label Learning with Missing Labels Using Mixed Dependency Graphs

    KAUST Repository

    Wu, Baoyuan

    2018-04-06

    This work focuses on the problem of multi-label learning with missing labels (MLML), which aims to label each test instance with multiple class labels given training instances that have an incomplete/partial set of these labels (i.e., some of their labels are missing). The key point to handle missing labels is propagating the label information from the provided labels to missing labels, through a dependency graph that each label of each instance is treated as a node. We build this graph by utilizing different types of label dependencies. Specifically, the instance-level similarity is served as undirected edges to connect the label nodes across different instances and the semantic label hierarchy is used as directed edges to connect different classes. This base graph is referred to as the mixed dependency graph, as it includes both undirected and directed edges. Furthermore, we present another two types of label dependencies to connect the label nodes across different classes. One is the class co-occurrence, which is also encoded as undirected edges. Combining with the above base graph, we obtain a new mixed graph, called mixed graph with co-occurrence (MG-CO). The other is the sparse and low rank decomposition of the whole label matrix, to embed high-order dependencies over all labels. Combining with the base graph, the new mixed graph is called as MG-SL (mixed graph with sparse and low rank decomposition). Based on MG-CO and MG-SL, we further propose two convex transductive formulations of the MLML problem, denoted as MLMG-CO and MLMG-SL respectively. In both formulations, the instance-level similarity is embedded through a quadratic smoothness term, while the semantic label hierarchy is used as a linear constraint. In MLMG-CO, the class co-occurrence is also formulated as a quadratic smoothness term, while the sparse and low rank decomposition is incorporated into MLMG-SL, through two additional matrices (one is assumed as sparse, and the other is assumed as low

  9. 10 CFR 61.57 - Labeling.

    Science.gov (United States)

    2010-01-01

    ... COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.57 Labeling. Each package of waste must be clearly labeled to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with § 61.55. ...

  10. 21 CFR 355.60 - Professional labeling.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Professional labeling. 355.60 Section 355.60 Food... HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 355.60 Professional... health professionals (but not to the general public) may contain the following additional dosage...

  11. How to Read a Nutrition Facts Label

    Medline Plus

    Full Text Available ... Educators Search English Español How to Read a Nutrition Facts Label (Video) KidsHealth / For Parents / How to Read a Nutrition Facts Label (Video) Print en español Cómo leer ...

  12. 21 CFR 660.55 - Labeling.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Labeling. 660.55 Section 660.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL... name such as polyspecific may appear in smaller type. (4) Visual inspection. When the label has been...

  13. How to Read a Nutrition Facts Label

    Medline Plus

    Full Text Available ... A) Staying Safe Videos for Educators Search English Español How to Read a Nutrition Facts Label (Video) ... Read a Nutrition Facts Label (Video) Print en español Cómo leer las etiquetas de datos nutricionales (video) ...

  14. Synthesis and application of labelled growth regulators

    International Nuclear Information System (INIS)

    Shyutte, G.R.

    1982-01-01

    For the investigation of the metabolism both of phytoeffectors like herbicides and plant growth regulators such compounds are needed in radioactive labelled form. The synthesis of radioactive labelled fluorodifen, nitrofen, ethephon, diphenylic acetic acid, 2,4-dichlorophenoxyisobutyric acid, abscisic acid, hydroxybenzoic acids and different conjugates are described. Some examples of these compounds metabolism in plants are discussed [ru

  15. How to Read a Nutrition Facts Label

    Medline Plus

    Full Text Available ... Watch this video for tips on figuring out food labels so you can make healthy choices. More on this topic for: Parents Kids Teens Keeping Portions Under Control Figuring Out Food Labels Healthy Food Shopping If My Child Has ...

  16. 10 CFR 20.1904 - Labeling containers.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Labeling containers. 20.1904 Section 20.1904 Energy....1904 Labeling containers. (a) The licensee shall ensure that each container of licensed material bears... handling or using the containers, or working in the vicinity of the containers, to take precautions to...

  17. The anatomy of a laser label

    Science.gov (United States)

    Laser labeling of fruits and vegetables is an efficient alternative to adhesive tags. The advantages of this system are numerous. In general the label consists of alphanumerical characters formed by laser generated pinhole depressions that penetrate the produce’s surface creating visible markings. H...

  18. 76 FR 45715 - Appliance Labeling Rule

    Science.gov (United States)

    2011-08-01

    ... foreign country equivalent, passport number, financial account number, or credit or debit card number. You..., the Commission assumes that the label design change will be implemented by graphic designers at an... label design change will be implemented by graphic designers at an hourly wage rate of $23.44 per hour...

  19. Do European consumers use nutrition labels?

    DEFF Research Database (Denmark)

    Wills, Josephine M.; Grunert, Klaus G.; Celemín, Laura Fernández

    2009-01-01

    Nutrition labelling on food packages becomes more and more widespread in the European Union. Such information is not compulsory, unless a nutrition or health claim is made. However, how do consumers use nutrition information? Two European studies are currently assessing whether nutrition...... knowledge about nutrition and are able to use nutrition labels to identify healthier products within a category....

  20. Synthesis of tritium-labeled fosfomycin

    International Nuclear Information System (INIS)

    Mertel, H.E.; Meriwether, H.T.

    1982-01-01

    Tritium gas was used as a labeling agent for the preparation of [1,2- 3 H]fosfomycin. Introduction of tritium into a precursor, the synthesis including resolution of the intermediate racemic 1,2-epoxypropylphosphonic acid, and preparation of both amine and calcium salts of the labeled antibiotic are described. (author)

  1. A note on root projection and labelling*

    African Journals Online (AJOL)

    Kate H

    Abstract. This paper identifies a problem with a hypothesis put forward in Chomsky (2013) in relation to his labelling algorithm. Chomsky suggests that category-neutral roots do not qualify as labels and cannot project. However, I provide evidence that the derivation of particle verbs involves the projection of a ...

  2. How to Read a Nutrition Facts Label

    Medline Plus

    Full Text Available ... label. These labels have a lot of important information — on fat and calories, serving sizes, sodium content, ... Nondiscrimination Visit the Nemours Web site. Note: All information on KidsHealth® is for educational purposes only. For ...

  3. Radial contour labeling with straight leaders

    NARCIS (Netherlands)

    Niedermann, B.; Nöllenburg, M.; Rutter, I.

    2017-01-01

    The usefulness of technical drawings as well as scientific illustrations such as medical drawings of human anatomy essentially depends on the placement of labels that describe all relevant parts of the figure. In order to not spoil or clutter the figure with text, the labels are often placed around

  4. 21 CFR 895.25 - Labeling.

    Science.gov (United States)

    2010-04-01

    ... labeling or advertising of the device. (d) If such voluntary action is not taken, the Commissioner may take... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES BANNED DEVICES General Provisions § 895.25 Labeling. (a) If the Commissioner determines that the...

  5. Imaging with 123I labelled fatty acids

    International Nuclear Information System (INIS)

    Dudczak, R.

    1985-01-01

    This report describes the clinical results obtained with radioiodinated aromatic and aliphatic fatty acids. The radiopharmaceuticals were 123 I labelled p-phenylpentadecanoic (p-IPPA) and 123 I labelled heptadecanoic acid (HDA). The possibility to evaluate the myocardial metabolic function in man noninvasively add a complementary diagnostic tool in the clinical follow-up of patients with heart disease. (Auth.)

  6. Hippuran-123 I: labelling and quality control

    International Nuclear Information System (INIS)

    Barboza, M.F. de; Colturato, M.T.; Herrerias, R.; Muramoto, E.

    1992-01-01

    The o-iodo hippuric acid labelling with radioiodine is a radiopharmaceutical used with more frequently for evaluation the kidney function. Several reactive kits for labelling with 123 I are prepared. Controls of radiochemical purity and biological distribution are made. The reactive kit of hippuran is kept at 4 C during 2 years. (C.G.C.)

  7. 49 CFR 172.407 - Label specifications.

    Science.gov (United States)

    2010-10-01

    ...) Design. (1) Except for size and color, the printing, inner border, and symbol on each label must be as... withstand, without deterioration or a substantial change in color, a 30-day exposure to conditions incident... shown in the appropriate section of this subpart. (d) Color. (1) The background color on each label must...

  8. Energy labelling of refrigerated display cases

    NARCIS (Netherlands)

    Sluis, S.M. van der

    1996-01-01

    Energy labelling of refrigerated display cabinets is a method to quickly assess the energy efficiency of a certain cabinet compared to the market average consumptions for similar cabinets. Labelling is also a method to obtain comparable data on cabinets from different manufacturers, which has time

  9. Mixed labelling in multitarget particle filtering

    NARCIS (Netherlands)

    Boers, Y.; Sviestins, Egils; Driessen, Hans

    2010-01-01

    The so-called mixed labelling problem inherent to a joint state multitarget particle filter implementation is treated. The mixed labelling problem would be prohibitive for track extraction from a joint state multitarget particle filter. It is shown, using the theory of Markov chains, that the mixed

  10. 19 CFR 12.18 - Labels.

    Science.gov (United States)

    2010-04-01

    ... 19 Customs Duties 1 2010-04-01 2010-04-01 false Labels. 12.18 Section 12.18 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY SPECIAL CLASSES OF MERCHANDISE Viruses, Serums, and Toxins for Treatment of Domestic Animals § 12.18 Labels. Each...

  11. How to Read a Nutrition Facts Label

    Medline Plus

    Full Text Available ... Behavior School & Family Life First Aid & Safety Doctors & Hospitals Videos Recipes for Kids Kids site Sitio para ... nutricionales (video) Most packaged foods come with a Nutrition Facts label. These labels have a lot of important ... Policy Permissions Guidelines Privacy Policy & Terms of Use Notice ...

  12. Conformational change of spin labelled myoglobin

    International Nuclear Information System (INIS)

    Wajnberg, E.; Ribeiro, P.C.; Nascimento, O.R.; Bemski, G.

    1978-01-01

    A conformational change of spin labelled myoglobin have been followed by measuring the spin label's (isothiocyanate) correlation time for temperatures between 18 0 C and 44 0 C. The correlation time was calculated from Electrom Paramagnetic Ressonance Spectra using the components of the espectroscopic and hiperfine tensors obtained by fitting the powder spectra using Lefebvre and Maruani's program- [pt

  13. Figuring Out Food Labels (For Kids)

    Science.gov (United States)

    ... First Aid & Safety Doctors & Hospitals Videos Recipes for Kids Kids site Sitio para niños How the Body Works ... English Español Figuring Out Food Labels KidsHealth / For Kids / Figuring Out Food Labels What's in this article? ...

  14. Off-label prescriptions in diabetic foot

    Directory of Open Access Journals (Sweden)

    Luís Jesuíno de Oliveira Andrade

    2014-09-01

    Full Text Available Prescription of a drug outside of the indications for which it was originally approved by regulators is internationally known as "off-label" prescription. We describe off-label treatments for the diabetic foot reported in international scientific literature. This is a qualitative and descriptive bibliographical review based on the results of a search of the Medline international database. The criteria for review were publication between January 1985 and November 2013, and the MeSH (Medical Subject Heading keywords "off-label use" OR "off-label" OR "off-label prescribing" plus "diabetic foot" were input on the search form. Nine studies were selected that contained information about off-label treatments for the diabetic foot. We conclude that the practice of off-label prescribing has potential benefits. In some situations an off-label prescription is the only treatment available for patients, either because a more targeted drug does not exist, or because other methods of treatment are ineffective or unavailable due to patient intolerance.

  15. 7 CFR 56.73 - Misleading labeling.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Misleading labeling. 56.73 Section 56.73 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards... EGGS Grading of Shell Eggs Denial of Service § 56.73 Misleading labeling. The use of the terms...

  16. Two Responses to Hastings on Labeling.

    Science.gov (United States)

    Somogyi, Katherine M. M.; And Others

    1995-01-01

    Two comments respond to an R. P. Hastings article on labeling of individuals with mental retardation. The first comment notes that diagnoses should not be used as labels but as identifications of disorders a person has. The second comment calls for people to come forth with synonyms for "mental retardation" that will not immediately be stigmatic.…

  17. Private labels : The brands of the future

    NARCIS (Netherlands)

    Keller, Kristopher

    2017-01-01

    This dissertation consists of three essays that study private labels’ evolution from private labels as brand class to individual private-label brands from three different perspectives. In the second chapter of this dissertation (essay 1), I study the antecedents and performance implications of

  18. Proposal for a New Energy Label

    DEFF Research Database (Denmark)

    Schjær-Jacobsen, Jørgen

    2011-01-01

    Energy labeling is believed to have great impact on the energy efficiency of household appliances sold. Many different labeling schemes exist around the world. As far as is known, none of these facilitates the easy tightening of specifications to keep up with technological advancements. The present...

  19. Label-controlled optical packet routing technologies and applications

    DEFF Research Database (Denmark)

    Koonen, A.M.J.; Yan, N.; Vegas Olmos, Juan José

    2007-01-01

    An overview is given of various optical packet labeling techniques. The architecture and technologies are discussed for optical packet routing nodes using orthogonal labeling with optoelectronic label processing, and for nodes using time-serial labeling with all-optical time-serial label processing...

  20. 49 CFR 172.416 - POISON GAS label.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false POISON GAS label. 172.416 Section 172.416... SECURITY PLANS Labeling § 172.416 POISON GAS label. (a) Except for size and color, the POISON GAS label... POISON GAS label and the symbol must be white. The background of the upper diamond must be black and the...

  1. Recent developments in blood cell labeling research

    Energy Technology Data Exchange (ETDEWEB)

    Srivastava, S.C.; Straub, R.F.; Meinken, G.E.

    1988-09-07

    A number of recent developments in research on blood cell labeling techniques are presented. The discussion relates to three specific areas: (1) a new in vitro method for red blood cell labeling with /sup 99m/Tc; (2) a method for labeling leukocytes and platelets with /sup 99m/Tc; and (3) the use of monoclonal antibody technique for platelet labeling. The advantages and the pitfalls of these techniques are examined in the light of available mechanistic information. Problems that remain to be resolved are reviewed. An assessment is made of the progress as well as prospects in blood cell labeling methodology including that using the monoclonal antibody approach. 37 refs., 4 figs.

  2. Labeled estrogens as mammary tumor probes

    International Nuclear Information System (INIS)

    Feenstra, A.

    1981-01-01

    In this thesis estrogens labeled with a gamma or positron emitting nuclide, called estrogen-receptor binding radiopharmaceuticals are investigated as mammary tumour probes. The requirements for estrogen-receptor binding radiopharmaceuticals are formulated and the literature on estrogens labeled for this purpose is reviewed. The potential of mercury-197/197m and of carbon-11 as label for estrogen-receptor binding radiopharmaceuticals is investigated. The synthesis of 197 Hg-labeled 4-mercury-estradiol and 2-mercury-estradiol and their properties in vitro and in vivo are described. It appears that though basically carbon-11 labeled compounds are very promising as mammary tumour probes, their achievable specific activity has to be increased. (Auth.)

  3. Tritium labelling of two new analgesic drugs

    International Nuclear Information System (INIS)

    Santamaria, J.; Rebollo, D.V.; Rivera, P.; Esteban, M.

    1986-01-01

    The labelling with tritium of two arylpropionic esters was studied. The synthesis between 3 H-Ibuprofen and the two unlabelled alcoholic moieties (Cl-Alkanol and CF 3 -Alkanol) was performed. Assuming that we got ready the acidic moiety, 3 H-Ibuprofen, in our Laboratory, we attempted to label with tritium the alcoholic moiety and then go on to its esterification. Prior to labelling, thermic stability of 2-(4-(3-chlorophenyl)-1-piperazinyl) ethanol (Cl-Alkanol) was studied. As result of this study we had to change the labelling method, so that the Cl-Alkanol was unstable at 70 0 C. Purification was accomplished through thin layer chromatography (TLC) and high performance liquid chromatography (HPLC). Concentration, purity and specific activities of the two labelled compounds were determined by ultraviolet, HPLC and liquid scintillation techniques. (author)

  4. Preparation of 188Re labelled antibodies

    International Nuclear Information System (INIS)

    Zhu Minghua; Cao Rongzhen; Li Wenxin; Sheng Rong; Yin Duanzhi; He Weiyu; Zhou Wei; Wang Yongxian

    1998-01-01

    A simple technique of directly labelling antibodies with 188 Re has been developed. The reduction of antibody disulfide groups was achieved by incubation of antibody with ascorbic acid (pH = 6.5) for an hour at room temperature and a solution of excess SnCl 2 in sodium gluconate was added to the AA-reduced antibody followed by the addition of perrhenate. Some factors that influence labelling efficiency, such as the pH of the reaction mixture, the labelling time, and the amount of antibodies and reductive agent, were studied experimentally and a better labelling method was established. The labelling yields, as determined by paper chromatography, were greater than 80%

  5. Recent developments in blood cell labeling research

    International Nuclear Information System (INIS)

    Srivastava, S.C.; Straub, R.F.; Meinken, G.E.

    1988-01-01

    A number of recent developments in research on blood cell labeling techniques are presented. The discussion relates to three specific areas: (1) a new in vitro method for red blood cell labeling with /sup 99m/Tc; (2) a method for labeling leukocytes and platelets with /sup 99m/Tc; and (3) the use of monoclonal antibody technique for platelet labeling. The advantages and the pitfalls of these techniques are examined in the light of available mechanistic information. Problems that remain to be resolved are reviewed. An assessment is made of the progress as well as prospects in blood cell labeling methodology including that using the monoclonal antibody approach. 37 refs., 4 figs

  6. Labeling of creatinine with technetium-99m

    Energy Technology Data Exchange (ETDEWEB)

    Yurt Lambrecht, F. [Ege Univ., Bornova, Izmir (Turkey). Dept. of Nuclear Applications, Inst. of Nuclear Sciences; Durkan, K. [Dokuz Eylul Univ., Buca, Izmir (Turkey). Chemistry Technicianship Program, Izmir Vocational School; Soylu, A. [Dokuz Eylul Univ., Narlidere, Izmir (Turkey). Dept. of Pediatrics, Medical Faculty

    2004-07-01

    Creatinine is a clinically important index of renal glomerular filtration rate. Urine creatinine levels can be used as a screening test to evaluate kidney function or can be part of the creatinine clearance test. In case of kidney dysfunction or muscle disorders the creatinine concentration in serum/plasma may rise to a higher value than in healthy body. Technetium- 99m has been used in nuclear medicine and in biomedical research to label molecular and cellular structures employed as radiotracers. {sup 99m}Tc is utilized to label molecules and cells, used as radiopharmaceuticals, and also to label biological species. It presents many desirable characteristics. SnCl{sub 2} method is frequently used as a reducing agent in the {sup 99m}Tc- labeling process. Creatinine metabolism might be investigated by using labeled {sup 99m}Tc- creatinine in healthy or uremic rats. (orig.)

  7. Energy labeling for electric fans in Malaysia

    International Nuclear Information System (INIS)

    Mahlia, T.M.I.; Masjuki, H.H.; Taha, F.M.; Rahim, N.A.; Saidur, R.

    2005-01-01

    To reduce energy consumption in the residential sector, Malaysia Energy Commission is considering implementing energy labels for household electrical appliances including electric fans in 2005. The purpose of the energy labels is to provide the consumers a guideline to compare the size, features, price and efficiency of the appliance. This paper discusses the energy label for electric fans in this country based on Malaysian Standards developed by a technical committee that reviewed the performance of household electrical appliances. This study includes methodology for the calculation of the energy efficiency star rating and projected energy usage, performance requirements, details of the energy label and the requirements for the valid application in Malaysia. The label also can be adopted for other household electrical appliances with only slight modifications

  8. Surgical outcomes of robot-assisted rectal cancer surgery using the da Vinci Surgical System: a multi-center pilot Phase II study.

    Science.gov (United States)

    Tsukamoto, Shunsuke; Nishizawa, Yuji; Ochiai, Hiroki; Tsukada, Yuichiro; Sasaki, Takeshi; Shida, Dai; Ito, Masaaki; Kanemitsu, Yukihide

    2017-12-01

    We conducted a multi-center pilot Phase II study to examine the safety of robotic rectal cancer surgery performed using the da Vinci Surgical System during the introduction period of robotic rectal surgery at two institutes based on surgical outcomes. This study was conducted with a prospective, multi-center, single-arm, open-label design to assess the safety and feasibility of robotic surgery for rectal cancer (da Vinci Surgical System). The primary endpoint was the rate of adverse events during and after robotic surgery. The secondary endpoint was the completion rate of robotic surgery. Between April 2014 and July 2016, 50 patients were enrolled in this study. Of these, 10 (20%) had rectosigmoid cancer, 17 (34%) had upper rectal cancer, and 23 (46%) had lower rectal cancer; six underwent high anterior resection, 32 underwent low anterior resection, 11 underwent intersphincteric resection, and one underwent abdominoperineal resection. Pathological stages were Stage 0 in 1 patient, Stage I in 28 patients, Stage II in 7 patients and Stage III in 14 patients. Pathologically complete resection was achieved in all patients. There was no intraoperative organ damage or postoperative mortality. Eight (16%) patients developed complications of all grades, of which 2 (4%) were Grade 3 or higher, including anastomotic leakage (2%) and conversion to open surgery (2%). The present study demonstrates the feasibility and safety of robotic rectal cancer surgery, as reflected by low morbidity and low conversion rates, during the introduction period. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  9. Insight into the labeling mechanism of acceleration selective arterial spin labeling

    DEFF Research Database (Denmark)

    Schmid, Sophie; Petersen, Esben T; Van Osch, Matthias J P

    2017-01-01

    OBJECTIVES: Acceleration selective arterial spin labeling (AccASL) is a spatially non-selective labeling technique, used in traditional ASL methods, which labels spins based on their flow acceleration rather than spatial localization. The exact origin of the AccASL signal within the vasculature......-ASL, combined AccASL and VS-ASL signal, and signal from one module with crushing from the other. RESULTS: The label created with AccASL has an overlap of approximately 50% in the vascular region with VS-ASL, but also originates from smaller vessels closer to the capillaries. CONCLUSION: AccASL is able to label...

  10. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia

    DEFF Research Database (Denmark)

    Branco, Jaime C; Zachrisson, Olof; Perrot, Serge

    2010-01-01

    This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population.......This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population....

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

    DEFF Research Database (Denmark)

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

    2013-01-01

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

  12. Does the Drug Facts Label for nonprescription drugs meet its design objectives? A new procedure for assessing label effectiveness

    Directory of Open Access Journals (Sweden)

    Michael P Ryan

    2017-07-01

    Full Text Available We demonstrate an expanded procedure for assessing drug-label comprehension. Innovations include a pretest of drug preconceptions, verbal ability and label attentiveness measures, a label-scanning task, a free-recall test, category-clustering measures, and preconception-change scores. In total, 55 female and 39 male undergraduates read a facsimile Drug Facts Label for aspirin, a Cohesive-Prose Label, or a Scrambled-Prose Label. The Drug Facts Label outperformed the Scrambled-Prose Label, but not the Cohesive-Prose Label, in scanning effectiveness. The Drug Facts Label was no better than the Cohesive-Prose Label or the Scrambled-Prose Label in promoting attentiveness, recall and organization of drug facts, or misconception refutation. Discussion focuses on the need for refutational labels based on a sequence-of-events text schema.

  13. Research priorities for a multi-center child abuse pediatrics network - CAPNET.

    Science.gov (United States)

    Lindberg, Daniel M; Wood, Joanne N; Campbell, Kristine A; Scribano, Philip V; Laskey, Antoinette; Leventhal, John M; Pierce, Mary Clyde; Runyan, Desmond K

    2017-03-01

    Although child maltreatment medical research has benefited from several multi-center studies, the new specialty of child abuse pediatrics has not had a sustainable network capable of pursuing multiple, prospective, clinically-oriented studies. The Child Abuse Pediatrics Network (CAPNET) is a new multi-center research network dedicated to child maltreatment medical research. In order to establish a relevant, practical research agenda, we conducted a modified Delphi process to determine the topic areas with highest priority for such a network. Research questions were solicited from members of the Ray E. Helfer Society and study authors and were sorted into topic areas. These topic areas were rated for priority using iterative rounds of ratings and in-person meetings. The topics rated with the highest priority were missed diagnosis and selected/indicated prevention. This agenda can be used to target future multi-center child maltreatment medical research. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Isolated optic nerve gliomas: a multicenter historical cohort study.

    Science.gov (United States)

    Shofty, Ben; Ben-Sira, Liat; Kesler, Anat; Jallo, George; Groves, Mari L; Iyer, Rajiv R; Lassaletta, Alvaro; Tabori, Uri; Bouffet, Eric; Thomale, Ulrich-Wilhelm; Hernáiz Driever, Pablo; Constantini, Shlomi

    2017-12-01

    OBJECTIVE Isolated optic nerve gliomas (IONGs) constitute a rare subgroup of optic pathway gliomas (OPGs). Due to the rarity of this condition and the difficulty in differentiating IONGs from other types of OPGs in most clinical series, little is known about these tumors. Currently, due to lack of evidence, they are managed the same as any other OPG. METHODS The authors conducted a multicenter retrospective cohort study aimed at determining the natural history of IONGs. Included were patients with clear-cut glioma of the optic nerve without posterior (chiasmatic/hypothalamic) involvement. At least 1 year of follow-up, 2 MRI studies, and 2 neuro-ophthalmological examinations were required for inclusion. RESULTS Thirty-six patients with 39 tumors were included in this study. Age at diagnosis ranged between 6 months and 16 years (average 6 years). The mean follow-up time was 5.6 years. Twenty-five patients had neurofibromatosis Type 1. During the follow-up period, 59% of the tumors progressed, 23% remained stable, and 18% (all with neurofibromatosis Type 1) displayed some degree of spontaneous regression. Fifty-one percent of the patients presented with visual decline, of whom 90% experienced further deterioration. Nine patients were treated with chemotherapy, 5 of whom improved visually. Ten patients underwent operation, and no local or distal recurrence was noted. CONCLUSIONS Isolated optic nerve gliomas are highly dynamic tumors. Radiological progression and visual deterioration occur in greater percentages than in the general population of patients with OPGs. Response to chemotherapy may be better in this group, and its use should be considered early in the course of the disease.

  15. Multicenter assessment of venous reflux by duplex ultrasound.

    Science.gov (United States)

    Lurie, Fedor; Comerota, Anthony; Eklof, Bo; Kistner, Robert L; Labropoulos, Nicos; Lohr, Joann; Marston, William; Meissner, Mark; Moneta, Gregory; Neglén, Peter; Neuhardt, Diana; Padberg, Frank; Welsh, Harold J

    2012-02-01

    This prospective multicenter investigation was conducted to define the repeatability of duplex-based identification of venous reflux and the relative effect of key parameters on the reproducibility of the test. Repeatability was studied by having the same technologist perform duplicate tests, at the same time of the day, using the same reflux-provoking maneuver and with the patient in the same position. Reproducibility was examined by having two different technologists perform the test at the same time of the day, using the same reflux-provoking maneuver and with the patient in the same position. Facilitated reproducibility was studied by having two different technologists examine the same patients immediately after an educational intervention. Limits of agreement between two duplex scans were studied by changing three elements of the test: time of the day (morning vs afternoon), patient's position (standing vs supine), and reflux initiation (manual vs automatic compression-decompression). The study enrolled 17 healthy volunteers and 57 patients with primary chronic venous disease. Repeatability of reflux time measurements in deep veins did not significantly differ with the time of day, the patient's position, or the reflux-provoking maneuver. Reflux measurements in the superficial veins were more repeatable (P ultrasound detection of venous reflux. Reports should include information on the time of the test, the patient's position, and the provoking maneuver used. Adopting a uniform cut point of 0.5 second for pathologic reflux can significantly improve the reliability of reflux detection. Implementation of a standard protocol should elevate the minimal standard for agreement between repeated tests from the current 70% to at least 80% and with more rigid standardization, to 90%. Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

  16. Decision making in liver transplant selection committees: a multicenter study.

    Science.gov (United States)

    Volk, Michael L; Biggins, Scott W; Huang, Mary Ann; Argo, Curtis K; Fontana, Robert J; Anspach, Renee R

    2011-10-18

    To receive a liver transplant, patients must first be placed on a waiting list-a decision made at most transplant centers by a multidisciplinary committee. The function of these committees has never been studied. To describe decision making in liver transplant committees and identify opportunities for process improvement. Observational multicenter study. 4 liver transplant centers in the United States. 68 members of liver transplant committees across the 4 centers. 63 meetings were observed, and 50 committee members were interviewed. Recorded transcripts and field notes were analyzed by using standard qualitative sociologic methods. Although the structure of the meetings varied by center, the process was uniform and primarily involved inductive reasoning to review possible reasons for patient exclusion. Patients were excluded if they were too well, too sick (in the setting of advanced liver disease), or too old or had nonhepatic comorbid conditions, substance abuse problems, or other psychosocial barriers. Dominant themes in the discussions included member angst over deciding who lived or died, a high correlation between psychosocial barriers to transplantation and the patient's socioeconomic status, and the influence of external forces on decision making. Unwritten center policies and confusion regarding advocacy versus stewardship roles were consistently identified as barriers to effective group decision making. The use of qualitative methods provides broad understanding but limits specific inferences. The 4 centers may not reflect the practices of every transplant center nationwide. The difficult decisions made by liver transplant committees are reasonably consistent and well-intentioned, but the process might be improved by having more explicit written policies and clarifying roles. This may inform resource allocation in other areas of medicine. The Greenwall Foundation and the National Institutes of Health.

  17. Urethroplasty after Urethral Urolume Stent: an International Multicenter Experience.

    Science.gov (United States)

    Angulo, Javier C; Kulkarni, Sanjay; Pankaj, Joshi; Nikolavsky, Dmitriy; Suarez, Pedro; Belinky, Javier; Virasoro, Ramón; DeLong, Jessica; Martins, Francisco E; Lumen, Nicolaas; Giudice, Carlos; Suárez, Oscar A; Menéndez, Nicolás; Capiel, Leandro; López-Alvarado, Damian; Ramirez, Erick A; Venkatesan, Krishnan; Husainat, Maha M; Esquinas, Cristina; Arance, Ignacio; Gómez, Reynaldo; Santucci, Richard

    2018-05-08

    To evaluate the outcomes and factors affecting success of urethroplasty in patients with stricture recurrence after Urolume® urethral stent. Retrospective international multicenter study on patients treated with urethral reconstruction after Urolume® stent. Stricture and stent length, time between urethral stent insertion and urethroplasty, age, mode of stent retrieval, type of urethroplasty, complications and baseline and post-urethroplasty voiding parameters were analyzed. Successful outcome was defined as standard voiding, without need of any postoperative adjunctive procedure. Sixty-three patients were included. Stent was removed at urethroplasty in 61 patients. Reconstruction technique was excision and primary anastomosis in 14(22.2%), dorsal onlay buccal mucosa graft (BMG) 9(14.3%), ventral onlay BMG 6(9.5%), dorso-lateral onlay BMG 9(14.3%), ventral onlay plus dorsal inlay BMG 3(4.8%), augmented anastomosis 5(7.9%), pedicled flap urethroplasty 6(9.5%), 2-stage procedure 4(6.4%) and perineal urethrostomy 7(11.1%). Success rate was 81% at a mean 59.7+63.4months. Dilatation and/or internal urethrotomy was performed in 10(15.9%), redo-urethroplasty in 5(7.9%). Total IPSS, QoL, Qmax and PVR significantly improved (pUrethroplasty in patients with Urolume® urethral stents is a viable option of reconstruction with a high success rate and very acceptable complication rate. Numerous techniques are viable, however, urethral preservation, tine-by-tine stent extraction and use of BMG augmentation produced significantly better outcomes. Copyright © 2018 Elsevier Inc. All rights reserved.

  18. Maternal near-miss: a multicenter surveillance in Kathmandu Valley.

    Science.gov (United States)

    Rana, Ashma; Baral, Gehanath; Dangal, Ganesh

    2013-01-01

    Multicenter surveillance has been carried out on maternal near-miss in the hospitals with sentinel units. Near-miss is recognized as the predictor of level of care and maternal death. Reducing Maternal Mortality Ratio is one of the challenges to achieve Millennium Development Goal. The objective was to determine the frequency and the nature of near-miss events and to analyze the near-miss morbidities among pregnant women. A prospective surveillance was done for a year in 2012 at nine hospitals in Kathmandu valley. Cases eligible by definition were recorded as a census based on WHO near-miss guideline. Similar questionnaires and dummy tables were used to present the results by non-inferential statistics. Out of 157 cases identified with near-miss rate of 3.8 per 1000 live births, severe complications were postpartum hemorrhage 62 (40%) and preeclampsia-eclampsia 25 (17%). Blood transfusion 102 (65%), ICU admission 85 (54%) and surgery 53 (32%) were common critical interventions. Oxytocin was main uterotonic used both prophylactically and therapeutically at health facilities. Total of 30 (19%) cases arrived at health facility after delivery or abortion. MgSO4 was used in all cases of eclampsia. All laparotomies were performed within three hours of arrival. Near-miss to maternal death ratio was 6:1 and MMR was 62. Study result yielded similar pattern amongst developing countries and same near-miss conditions as the causes of maternal death reported by national statistics. Process indicators qualified the recommended standard of care. The near-miss event could be used as a surrogate marker of maternal death and a window for system level intervention.

  19. Determination of serum albumin, analytical challenges: a French multicenter study.

    Science.gov (United States)

    Rossary, Adrien; Blondé-Cynober, Françoise; Bastard, Jean-Philippe; Beauvieux, Marie-Christine; Beyne, Pascale; Drai, Jocelyne; Lombard, Christine; Anglard, Ingrid; Aussel, Christian; Claeyssens, Sophie; Vasson, Marie-Paule

    2017-06-01

    Among the biological markers of morbidity and mortality, albumin holds a key place in the range of criteria used by the High Authority for Health (HAS) for the assessment of malnutrition and the coding of information system medicalization program (PMSI). If the principle of quantification methods have not changed in recent years, the dispersion of external evaluations of the quality (EEQ) data shows that the standardization using the certified reference material (CRM) 470 is not optimal. The aim of this multicenter study involving 7 sites, conducted by a working group of the French Society of Clinical Biology (SFBC), was to assess whether the albuminemia values depend on the analytical system used. The albumin from plasma (n=30) and serum (n=8) pools was quantified by 5 different methods [bromocresol green (VBC) and bromocresol purple (PBC) colorimetry, immunoturbidimetry (IT), immunonephelometry (IN) and capillary electrophoresis (CE)] using 12 analyzers. Bland and Altman's test evaluated the difference between the results obtained by the different methods. For example, a difference as high as 13 g/L was observed for the same sample between the methods (p albumin across the range of values tested compared to PBC (p albumin values inducing a difference of performance between the immunoprecipitation methods (IT vs IN, p albumin results are related to the technical/analyzer tandem used. This variability is usually not taken into account by the clinician. Thus, clinicians and biologists have to be aware and have to check, depending on the method used, the albumin thresholds identified as risk factors for complications related to malnutrition and PMSI coding.

  20. Multicenter reliability of semiautomatic retinal layer segmentation using OCT

    Science.gov (United States)

    Oberwahrenbrock, Timm; Traber, Ghislaine L.; Lukas, Sebastian; Gabilondo, Iñigo; Nolan, Rachel; Songster, Christopher; Balk, Lisanne; Petzold, Axel; Paul, Friedemann; Villoslada, Pablo; Brandt, Alexander U.; Green, Ari J.

    2018-01-01

    Objective To evaluate the inter-rater reliability of semiautomated segmentation of spectral domain optical coherence tomography (OCT) macular volume scans. Methods Macular OCT volume scans of left eyes from 17 subjects (8 patients with MS and 9 healthy controls) were automatically segmented by Heidelberg Eye Explorer (v1.9.3.0) beta-software (Spectralis Viewing Module v6.0.0.7), followed by manual correction by 5 experienced operators from 5 different academic centers. The mean thicknesses within a 6-mm area around the fovea were computed for the retinal nerve fiber layer, ganglion cell layer (GCL), inner plexiform layer (IPL), inner nuclear layer, outer plexiform layer (OPL), and outer nuclear layer (ONL). Intraclass correlation coefficients (ICCs) were calculated for mean layer thickness values. Spatial distribution of ICC values for the segmented volume scans was investigated using heat maps. Results Agreement between raters was good (ICC > 0.84) for all retinal layers, particularly inner retinal layers showed excellent agreement across raters (ICC > 0.96). Spatial distribution of ICC showed highest values in the perimacular area, whereas the ICCs were poorer for the foveola and the more peripheral macular area. The automated segmentation of the OPL and ONL required the most correction and showed the least agreement, whereas differences were less prominent for the remaining layers. Conclusions Automated segmentation with manual correction of macular OCT scans is highly reliable when performed by experienced raters and can thus be applied in multicenter settings. Reliability can be improved by restricting analysis to the perimacular area and compound segmentation of GCL and IPL. PMID:29552598

  1. Maternal Near-Miss: A Multicenter Surveillance in Kathmandu Valley

    Directory of Open Access Journals (Sweden)

    Ashma Rana

    2013-06-01

    Full Text Available Introduction: Multicenter surveillance has been carried out on maternal near-miss in the hospitals with sentinel units. Near-miss is recognized as the predictor of level of care and maternal death. Reducing maternal mortality ratio is one of the challenges to achieve Millennium Development Goal. Objective was to determine the frequency and the nature of near-miss (severe acute maternal morbidity events and analysis of near-miss morbidities among pregnant women. Methods: Prospective surveillance was done for a year in 2012 in nine hospitals in Kathmandu valley. Cases eligible by definition recorded as a census based on WHO near-miss guideline. Similar questionnaire and dummy tables were used to present the result by non-inferential statistics. Results: Out of 157 cases identified with near-miss rate of 3.8, severe complications were PPH (40% and preeclampsia-eclampsia (17%. Blood transfusion (65%, ICU admission (54% and surgery (32% were the common critical intervention. Oxytocin was the main uterotonic used both prophylactically (86% and therapeutically (76%, and 19% arrived health facility after delivery or abortion. MgSO4 was used in all cases of eclampsia. All of the laparotomies were performed within 3 hours of arrival. Near-miss to mortality ratio was 6:1 and MMR 62. Conclusions: Study result yields similar pattern amongst developing countries and same near-miss conditions as the causes of maternal death reported by national statistics. Process indicators qualify the recommended standard of care. The near-miss event can be used as a surrogate marker of maternal death and a window for system level intervention. Keywords: abortion, eclampsia, hemorrhage, near-miss, surveillance

  2. Burnout Among Otolaryngology Residents in Saudi Arabia: A Multicenter Study.

    Science.gov (United States)

    Aldrees, Turki; Badri, Motasim; Islam, Tahera; Alqahtani, Khalid

    2015-01-01

    Determine the prevalence of, and associated risk factors for, burnout among otolaryngologist residents in Saudi Arabia. A cross-section study of multicenter hospitals in Saudi Arabia conducted in March 2013. Registered residents in Saudi Otolaryngology Board Program. The Maslach Burnout Inventory was used to measure burnout status. Questions supplementary to the Maslach Burnout Inventory were also included to identify associated potential risk factors such as demographic data, resident satisfaction, and work conditions. Of the initial 123 questionnaires that were distributed, 85 yielded responses, a rate of 69%. The mean age (standard deviation [SD]) of respondents was 29 (2.3) years. Of those, 67% (57/85) were men and 66% (55/85) were married. Resident levels were delineated: level 2, 19%; level 3, 33%; level 4, 29%; and level 5, 19%. The mean number of on-call days/month (SD) was 7 (2), clinics/week (SD) was 3 (1), sleep hours/day (SD) was 6 (1), and operations/week (SD) was 2 (1). The mean emotional exhaustion (EE) and depersonalization scores were high at 29.5 (SD = 9.6) and 10.7 (SD = 6), respectively. The mean personal accomplishment was low at 32.33 (SD = 6). The mean of all subscales did not differ by sex (EE p = 0.5; depersonalization p = 0.09; personal accomplishment p = 0.4). Mean EE differed by marital status, which was 31.2, 31.3, and 25.6 for married, divorced, and single, respectively, analysis of variance test p = 0.045. Burnout prevalence was found to be high among otolaryngologist residents in Saudi Arabia. The associated variables examined in this study should be addressed to decrease this level of burnout and provide residents with a less stressful work environment. Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  3. Divorce and Severity of Coronary Artery Disease: A Multicenter Study

    Directory of Open Access Journals (Sweden)

    Amin Daoulah

    2017-01-01

    Full Text Available The association between marital status and coronary artery disease (CAD is supported by numerous epidemiological studies. While divorce may have an adverse effect on cardiac outcomes, the relationship between divorce and severe CAD is unclear. We conducted a multicenter, observational study of consecutive patients undergoing coronary angiography during the period between April 1, 2013, and March 30, 2014. Of 1,068 patients, 124 (12% were divorced. Divorce was more frequent among women (27% compared to men (6%. Most divorced patients had been divorced only once (49%, but a subset had been divorced 2 (38% or ≥3 (12% times. After adjusting for baseline differences, there was no significant association between divorce and severe CAD in men. In women, there was a significant adjusted association between divorce and severe MVD (OR 2.31 [1.16, 4.59] or LMD (OR 5.91 [2.19, 15.99]. The modification of the association between divorce and severe CAD by gender was statistically significant for severe LMD (Pinteraction 0.0008 and marginally significant for CAD (Pinteraction 0.05. Among women, there was a significant adjusted association between number of divorces and severe CAD (OR 2.4 [95% CI 1.2, 4.5], MVD (OR 2.0 [95% CI 1.4, 3.0], and LMD (OR 3.4 [95% CI 1.9, 5.9]. In conclusion, divorce, particularly multiple divorces, is associated with severe CAD, MVD, and LMD in women but not in men.

  4. Underweight and malnutrition in home care: A multicenter study.

    Science.gov (United States)

    Lahmann, Nils A; Tannen, Antje; Suhr, Ralf

    2016-10-01

    This study aimed to provide representative figures about the prevalence of underweight and malnutrition among home care clients, and to determine the associated risk factors and the provided nutritional nursing interventions. In 2012, a multicenter point prevalence study was conducted among 878 randomly selected clients from 100 randomly selected home care services across Germany. Following a standardized study protocol, demographics, nutritional assessments (Body Mass Index, Malnutrition Universal Screening Tool (MUST), Mini nutritional Assessment - short form (MNA-sf), nurses' clinical judgment on nutritional status) and interventions were assessed. Common nutritional risk factors for underweight and malnutrition were analyzed in a logistic regression model. Malnutrition figures varied between 4.8% (MNA-sf) and 6.8% (MUST), underweight between 8.7% (BMI malnutrition assessments (MNA-sf 48.8%, MUST 39.1%) due to a lack of information on many clients' loss of weight within the past 3-6 months. Regular weighing was performed in 33.6-57.3% of all clients, depending on weight and nutritional status. Mental overload (OR 8.1/4.4), needs help with feeding (OR 5.0/2.8) and loss of appetite (OR 3.6/3.9) were highly associated with malnutrition/underweight. Malnutrition and underweight are important issues in home care clients. Regular weighing should be performed in all home care clients so that a potential weight loss can be detected in time. Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  5. 99Tcsup(m)-HMPAO labelled leucocytes: comparison with 111In-tropolonate labelled granulocytes

    International Nuclear Information System (INIS)

    Peters, A.M.; Roddie, M.E.; Zacharopoulos, G.P.; George, P.; Stuttle, A.W.J.; Lavender, J.P.; Danpure, H.J.; Osman, S.

    1988-01-01

    The lipophilic complex, 99 Tcsup(m)-hexamethylpropyleneamine oxime (HMPAO) is an efficient leucocyte label, and labels granulocytes with more stability than mononuclear leucocytes. The recovery of 99 Tcsup(m)-HMPAO granulocytes was similar to 111 In-labelled granulocytes isolated and labelled in plasma using tropolone. The Tsub(1/2) of 99 Tcsup(m)-HMPAO labelled granulocytes in blood was less than that of 111 In-labelled granulocytes. The initial biodistribution of 99 Tcsup(m)-labelled leucocytes was similar to 111 In-labelled granulocytes, with a rapid initial lung transit, prominent splenic activity, bone marrow activity and minimal hepatic activity, although, unlike 111 In, 99 Tcsup(m) activity was also seen in urine, occasionally in the gallbladder, and, from about 4 h, consistently in the colon. Bone marrow activity was particularly prominent with 99 Tcsup(m). About 6% of 99 Tcsup(m) was excreted in the faeces up to 48 h after injection, and about 17% in urine up to 24 h. The time-activity curves of reticuloendothelial activity up to 24 h were broadly similar for the two labelled cell preparations. Clinical information given by the two agents was similar in 27 of 30 patients who received both. We conclude that with respect to granulocyte kinetics and clinical data, 99 Tcsup(m)-HMPAO labelled leucocytes are comparable with 111 In-tropolonate labelled granulocytes. (author)

  6. Efficient Multi-Label Feature Selection Using Entropy-Based Label Selection

    Directory of Open Access Journals (Sweden)

    Jaesung Lee

    2016-11-01

    Full Text Available Multi-label feature selection is designed to select a subset of features according to their importance to multiple labels. This task can be achieved by ranking the dependencies of features and selecting the features with the highest rankings. In a multi-label feature selection problem, the algorithm may be faced with a dataset containing a large number of labels. Because the computational cost of multi-label feature selection increases according to the number of labels, the algorithm may suffer from a degradation in performance when processing very large datasets. In this study, we propose an efficient multi-label feature selection method based on an information-theoretic label selection strategy. By identifying a subset of labels that significantly influence the importance of features, the proposed method efficiently outputs a feature subset. Experimental results demonstrate that the proposed method can identify a feature subset much faster than conventional multi-label feature selection methods for large multi-label datasets.

  7. ORGANIC FOOD LABELING AND CERTIFICATION

    Directory of Open Access Journals (Sweden)

    NICOLETA-ANDREEA NEACSU

    2011-04-01

    Full Text Available In the rush to produce more and more crops to satisfy growing demand producers have had to resort to using a lethal cocktail of pesticides to control disease and insect attack. This has lead to numerous international debates about unhealthy food, the effects of it and the measures that must be taken in order to avoid the harmful effects of genetically modified food consumption demonstrated by specialists. These debates evolve around the benefits of the organic products versus the pure trade trick outlined by some. The organic food movement has earned its well deserved place in many markets around the world. Its prestige is lately being widespread to vast parts of Eastern-Europe as well. Based on data collected from specialized reports and articles on organic products, the aim of this paper is to present the importance of organic products, the regulations on organic food and different labels used around the world in order to certify the organic food products.

  8. Tug-of-war between classical and multicenter bonds in H-(Be)n-H species

    Science.gov (United States)

    Lundell, Katie A.; Boldyrev, Alexander I.

    2018-05-01

    Quantum chemical calculations were performed for beryllium homocatenated compounds [H-(Be)n-H]. Global minimum structures were found using machine searches (Coalescence Kick method) with density functional theory. Chemical bonding analysis was performed with the Adaptive Natural Density Partitioning method. It was found that H-(Be)2-H and H-(Be)3-H clusters are linear with classical two-center two-electron bonds, while for n > 3, three-dimensional structures are more stable with multicenter bonding. Thus, at n = 4, multicenter bonding wins the tug-of-war vs. the classical bonding.

  9. "Why Mama and Papa?" The Development of Social Labels.

    Science.gov (United States)

    Brooks-Gunn, Jeanne; Lewis, Michael

    1979-01-01

    Examined social labels first used for parents, differentiation of parents and others on the basis of labeling behavior, and overgeneralization of social labels in 71 infants ranging in age from 9 to 24 months. (JMB)

  10. 27 CFR 4.50 - Certificates of label approval.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF WINE Requirements for Approval of Labels of... of exemption from label approval, as well as appeal procedures, see part 13 of this chapter. [T.D...

  11. 27 CFR 5.55 - Certificates of label approval.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF DISTILLED SPIRITS Requirements for Approval of... certificates of label approval and certificates of exemption from label approval, as well as appeal procedures...

  12. Tritium labeling for bio-med research

    International Nuclear Information System (INIS)

    Lemmon, R.M.

    1980-01-01

    A very large fraction of what we know about biochemical pathways in the living cell has resulted from the use of radioactively-labeled tracer compounds; the use of tritium-labeled compounds has been particularly important. As research in biochemistry and biology has progressed the need has arisen to label compounds of higher specific activity and of increasing molecular complexity - for example, oligo-nucleotides, polypeptides, hormones, enzymes. Our laboratory has gradually developed special facilities for handling tritium at the kilocurie level. These facilities have already proven extremely valuable in producing labeled compounds that are not available from commercial sources. The principal ways employed for compound labeling are: (1) microwave discharge labeling, (2) catalytic tritio-hydrogenation, (3) catalytic exchange with T 2 O, and (4) replacement of halogen atoms by T. Studies have also been carried out on tritiation by the replacement of halogen atoms with T atoms. These results indicate that carrier-free tritium-labeled products, including biomacromolecules, can be produced in this way

  13. Labelling of food: A challenge for many

    Directory of Open Access Journals (Sweden)

    Henderikx Frans

    2017-01-01

    Full Text Available Background: In food marketing, there is a trend towards artisanal, traditional “honest” food, and simultaneously to good looking, long lasting, multi-purpose food with a clean label. In addition, marketeers like to upgrade the image of the food, including the label, using various digital techniques. This can produce (unintended non-conformities with the current food law on labelling, which in this review, refers to Regulation (EU No 1169/2011 (European Union, 2011. Food and meat labelling have been subjected to increased regulation in the recent years, sometimes after scandals (horse-gate, food fraud, sometimes due to wishes of consumer organisations (nutritional information and sometimes after the introduction of new types of ingredients (sweeteners, phytosterols, nanomaterials. Scope and approach: This review provides information about food labelling. Some experiences gathered by food inspectorate personnel in practice, with reference to the literature data, positive aspects, main problems and trends are discussed. Key findings and conclusion: Food labelling is a complex requirement, with the general demands written down in the harmonized regulation (European Union, 2011. Foods sold by e-commerce must also follow these same regulations. However, many food labels on the market show smaller and/or bigger deviations from the legal requirements, which should be appropriately addressed by the food manufacturers or packers, but also by the competent authorities. Even training of consumers seems to be needed, since all this information is, in the end, intended for consumers to aptly utilise.

  14. Consumer preferences for food allergen labeling.

    Science.gov (United States)

    Marra, Carlo A; Harvard, Stephanie; Grubisic, Maja; Galo, Jessica; Clarke, Ann; Elliott, Susan; Lynd, Larry D

    2017-01-01

    Food allergen labeling is an important tool to reduce risk of exposure and prevent anaphylaxis for individuals with food allergies. Health Canada released a Canadian food allergen labeling regulation (2008) and subsequent update (2012) suggesting that research is needed to guide further iterations of the regulation to improve food allergen labeling and reduce risk of exposure. The primary objective of this study was to examine consumer preferences in food labeling for allergy avoidance and anaphylaxis prevention. A secondary objective was to identify whether different subgroups within the consumer population emerged. A discrete choice experiment using a fractional factorial design divided into ten different versions with 18 choice-sets per version was developed to examine consumer preferences for different attributes of food labeling. Three distinct subgroups of Canadian consumers with different allergen considerations and food allergen labeling needs were identified. Overall, preferences for standardized precautionary and safety symbols at little or no increased cost emerged. While three distinct groups with different preferences were identified, in general the results revealed that the current Canadian food allergen labeling regulation can be improved by enforcing the use of standardized precautionary and safety symbols and educating the public on the use of these symbols.

  15. A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial).

    Science.gov (United States)

    Paajanen, Hannu; Grönroos, Juha M; Rautio, Tero; Nordström, Pia; Aarnio, Markku; Rantanen, Tuomo; Hurme, Saija; Dean, Kirsti; Jartti, Airi; Mecklin, Jukka-Pekka; Sand, Juhani; Salminen, Paulina

    2013-02-08

    Although the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial. The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18-60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point. The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75-85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting

  16. The association between insulin resistance and hepatic fibrosis in patients with chronic hepatitis C: an observational, multicenter study in Turkey.

    Science.gov (United States)

    Dökmeci, Abdulkadir; Ustündağ, Yücel; Hulagu, Saadettin; Tuncer, Ilyas; Akdoğan, Meral; Demirsoy, Hüseyin; Köklü, Seyfettin; Güzelbulut, Fatih; Doğan, Ibrahim; Demir, Ali; Akarsu, Mesut; Yüceyar, Hakan; Ozdoğan, Osman Cavit; Ozdener, Fatih; Erdoğan, Seda

    2014-10-01

    To evaluate the association between insulin resistance and hepatic fibrosis in patients with chronic hepatitis C. A total of 104 chronic hepatitis C patients were included in this non-interventional, open-label, observational, multicenter, cross-sectional study conducted at 20 gastroenterology clinics in Turkey. The primary end point was the correlation between stage of hepatic fibrosis and insulin resistance evaluated via the homeostasis model of assessment-insulin resistance index. Confounders of hepatic fibrosis and insulin resistance were the secondary end points. The mean age of patients was 52.8 years; 65.4% were female. Type 2 diabetes was present in 6.8% and insulin resistance noted in 38.0% of patients. Further, 45.7% of the patients had mild (A0/A1) and the remaining had moderate/severe (A2/A3) hepatic necroinflammatory activity. Patient distribution according to Metavir fibrosis stage was as follows: F0/F1 (57.0%); F2 (6.5%); F3 (23.7%); and F4 (12.9%). A univariate analysis revealed significant positive correlations between Metavir fibrosis stage and insulin resistance (r=0.297; p=0.007). Logistic regression analysis showed that significant predictors of insulin resistance were high alanine transaminase levels (odds ratio, 0.97; 95% confidence interval, 0.944-0.997) and liver fibrosis stage (odds ratio, 0.114; 95% confidence interval, 0.021-0.607). Our findings revealed significant associations between insulin resistance and hepatic fibrosis.

  17. Multicenter Retrospective Analysis of the Effectiveness and Safety of Rituximab in Korean Patients with Refractory Systemic Lupus Erythematosus

    Directory of Open Access Journals (Sweden)

    So-Young Bang

    2012-01-01

    Full Text Available Objective. Although two recent randomized placebo-controlled trials of rituximab (RTX failed to demonstrate efficacy in systemic lupus erythematosus (SLE, clinicians continue to use off-label RTX for cases refractory to current treatments. We evaluated the effectiveness and safety of rituximab for patients with refractory SLE in Korea. Methods. We retrospectively analyzed multicenter patients treated with RTX in Korea. Results. 39 SLE patients treated with RTX were included in the following manner: lupus nephritis 43.6%, hematologic 33.3%, arthritis 7.8%, myositis 7.8%, and others 7.7%. All patients had responded poorly to at least one conventional immunosuppressive agent (mean 2.5 ± 1.1, cyclophosphamide 43.6%, mycophenolate mofetil 48.7%, and other drugs before RTX. Clinical improvements (complete or partial remission occurred in patients with renal disease, hematologic disease, arthritis, myositis, and other manifestations at 6 months after RTX. The SLEDAI score was significantly decreased from 10.8±7.1 at baseline to 6.7±4.0 at 6 months, 6.2±4.1 at 12 months, and 5.5±3.6 at 24 months after RTX (P<0.05. Among 28 clinical responders, 4 patients experienced a relapse of disease at 25±4 months. Infections were noted in 3 patients (7.7%. Conclusion. RTX could be an effective and relatively safe therapeutic option in patients with severe refractory SLE until novel B-cell depletion therapy is available.

  18. Effectiveness of fentanyl transdermal patch (fentanyl-TTS, durogegic) for radiotherapy induced pain and cancer pain: multi-center trial

    International Nuclear Information System (INIS)

    Shin, Seong Soo; Choi, Eun Kyung; Huh, Seung Jae

    2006-01-01

    To evaluate the effectiveness and safety of fentanyl-TTS in the management of radiotherapy induced acute pain and cancer pain treated with radiotherapy. Our study was open labelled prospective phase IV multi-center study, the study population included patients with more 4 numeric rating scale (NRS) score pain although managed with other analgesics or more than 6 NRS score pain without analgesics. Patients divided into two groups: patients with radiotherapy induced pain (Group A) and patients with cancer pain treated with radiotherapy (Group B). All patients received 25 ug/hr of fentanyl transdermal patch. Primary end point was pain relief: second end points were change in patient quality of life, a degree of satisfaction for patients and clinician, side effects. Between March 2005 and June 2005, 312 patients from 26 participating institutes were registered, but 249 patients completed this study. Total number of patients in each group was 185 in Group A, 64 in Group B. Mean age was 60 years and male to female ratio was 76:24. Severe pain NRS score at 2 weeks after the application of fentanyl was decreased from 7.03 to 4.01, ρ = 0.003. There was a significant improvement in insomnia, social functioning, and quality of life. A degree of satisfaction for patients and clinician was very high. The most common reasons of patients' satisfactions was good pain control. Ninety six patients reported side effect. Nausea was the most common side effect. There was no serious side effect. Fentanyl-TTS was effective in both relieving pain with good tolerability and improving the quality of life for patients with radiotherapy induced acute pain and cancer pain treated with radiotherapy. The satisfaction of the patients and doctors was good. There wa no major side effect

  19. Renoprotective effects of topiroxostat for hyperuremic patients with overt diabetic nephropathy study (ETUDE Study): A prospective, randomized, multicenter clinical trial.

    Science.gov (United States)

    Mizukoshi, Toshihiro; Kato, Sawako; Ando, Masahiko; Sobajima, Hiroshi; Ohashi, Norimi; Naruse, Tomohiko; Saka, Yosuke; Shimizu, Hideaki; Nagata, Takanobu; Maruyama, Shoichi

    2017-10-09

    We aimed to evaluate the anti-albuminuric effects of topiroxostat in Japanese hyperuricemic patients with diabetic nephropathy. In this 24-week, multicenter, open-label, randomized (1:1) trial, we assigned hyperuricemic patients with diabetic nephropathy (estimated glomerular filtration rate ≥ 20 mL/min/1.73m 2 ) and overt proteinuria (0.3 ≤ urine protein to creatinine ratio (UPCR) <3.5 g/g Cr) to either high dose (160 mg daily) or low dose (40 mg daily) topiroxostat. The primary endpoint was the change in albuminuria indicated by urine albumin-to-creatinine ratio (UACR) from the baseline at the final time point. A total of 80 patients underwent randomization. The changes in UACR after 24 weeks of treatment (or at the final time point if patients failed to reach 24 weeks) relative to the baseline were -122 mg/gCr (95% CI: -5.1 to -240.1, P = 0.041) in patients treated with high dose, while treatment with low dose topiroxostat could not show significant reduction (P = 0.067). In the linear mixed model including baseline albuminuria, eGFR, age, and sex as covariates, the decreases in UACR were still significant from baseline to 12 weeks by 228.7 ± 83.2 mg/gCr (P = 0.0075) in the high dose group. The adverse-event profile during this study was not different between the groups. Topiroxostat 160 mg daily reduced albuminuria in patients with diabetic nephropathy. (Funded by Sanwa Kagaku Kenkyusho; Trial registration, UMIN000015403). This article is protected by copyright. All rights reserved.

  20. Effectiveness of fentanyl transdermal patch (fentanyl-TTS, durogegic) for radiotherapy induced pain and cancer pain: multi-center trial

    Energy Technology Data Exchange (ETDEWEB)

    Shin, Seong Soo; Choi, Eun Kyung [University of Ulsan College of Medicine, Seoul (Korea, Republic of); Huh, Seung Jae [Sungkyunkwan University College of Medicine, Seoul (Korea, Republic of)] (and others)

    2006-12-15

    To evaluate the effectiveness and safety of fentanyl-TTS in the management of radiotherapy induced acute pain and cancer pain treated with radiotherapy. Our study was open labelled prospective phase IV multi-center study, the study population included patients with more 4 numeric rating scale (NRS) score pain although managed with other analgesics or more than 6 NRS score pain without analgesics. Patients divided into two groups: patients with radiotherapy induced pain (Group A) and patients with cancer pain treated with radiotherapy (Group B). All patients received 25 ug/hr of fentanyl transdermal patch. Primary end point was pain relief: second end points were change in patient quality of life, a degree of satisfaction for patients and clinician, side effects. Between March 2005 and June 2005, 312 patients from 26 participating institutes were registered, but 249 patients completed this study. Total number of patients in each group was 185 in Group A, 64 in Group B. Mean age was 60 years and male to female ratio was 76:24. Severe pain NRS score at 2 weeks after the application of fentanyl was decreased from 7.03 to 4.01, {rho} = 0.003. There was a significant improvement in insomnia, social functioning, and quality of life. A degree of satisfaction for patients and clinician was very high. The most common reasons of patients' satisfactions was good pain control. Ninety six patients reported side effect. Nausea was the most common side effect. There was no serious side effect. Fentanyl-TTS was effective in both relieving pain with good tolerability and improving the quality of life for patients with radiotherapy induced acute pain and cancer pain treated with radiotherapy. The satisfaction of the patients and doctors was good. There wa no major side effect.

  1. Effect of probiotics on the incidence of ventilator-associated pneumonia in critically ill patients: a randomized controlled multicenter trial.

    Science.gov (United States)

    Zeng, Juan; Wang, Chun-Ting; Zhang, Fu-Shen; Qi, Feng; Wang, Shi-Fu; Ma, Shuang; Wu, Tie-Jun; Tian, Hui; Tian, Zhao-Tao; Zhang, Shu-Liu; Qu, Yan; Liu, Lu-Yi; Li, Yuan-Zhong; Cui, Song; Zhao, He-Ling; Du, Quan-Sheng; Ma, Zhuang; Li, Chun-Hua; Li, Yun; Si, Min; Chu, Yu-Feng; Meng, Mei; Ren, Hong-Sheng; Zhang, Ji-Cheng; Jiang, Jin-Jiao; Ding, Min; Wang, Yu-Ping

    2016-06-01

    To evaluate the potential preventive effect of probiotics on ventilator-associated pneumonia (VAP). This was an open-label, randomized, controlled multicenter trial involving 235 critically ill adult patients who were expected to receive mechanical ventilation for ≥48 h. The patients were randomized to receive (1) a probiotics capsule containing live Bacillus subtilis and Enterococcus faecalis (Medilac-S) 0.5 g three times daily through a nasogastric feeding tube plus standard preventive strategies or (2) standard preventive strategies alone, for a maximum of 14 days. The development of VAP was evaluated daily, and throat swabs and gastric aspirate were cultured at baseline and once or twice weekly thereafter. The incidence of microbiologically confirmed VAP in the probiotics group was significantly lower than that in the control patients (36.4 vs. 50.4 %, respectively; P = 0.031). The mean time to develop VAP was significantly longer in the probiotics group than in the control group (10.4 vs. 7.5 days, respectively; P = 0.022). The proportion of patients with acquisition of gastric colonization of potentially pathogenic microorganisms (PPMOs) was lower in the probiotics group (24 %) than the control group (44 %) (P = 0.004). However, the proportion of patients with eradication PPMO colonization on both sites of the oropharynx and stomach were not significantly different between the two groups. The administration of probiotics did not result in any improvement in the incidence of clinically suspected VAP, antimicrobial consumption, duration of mechanical ventilation, mortality and length of hospital stay. Therapy with the probiotic bacteria B. Subtilis and E. faecalis are an effective and safe means for preventing VAP and the acquisition of PPMO colonization in the stomach.

  2. Extending Modal Transition Systems with Structured Labels

    DEFF Research Database (Denmark)

    Bauer, Sebastian S.; Juhl, Line; Larsen, Kim Guldstrand

    2012-01-01

    We introduce a novel formalism of label-structured modal transition systems that combines the classical may/must modalities on transitions with structured labels that represent quantitative aspects of the model. On the one hand, the specification formalism is general enough to include models like...... weighted modal transition systems and allows the system developers to employ more complex label refinement than in the previously studied theories. On the other hand, the formalism maintains the desirable properties required by any specification theory supporting compositional reasoning. In particular, we...

  3. Synthesis of deuterium-labeled fluphenazine.

    Science.gov (United States)

    Shetty, H U; Hawes, E M; Midha, K K

    1984-01-01

    The propylpiperazine side chain of fluphenazine has been labeled with two, four, and six deuterium atoms by lithium aluminum deuteride reduction of the appropriate ester or imide. The gamma-carbon of the propyl group was labeled with two deuterium atoms by reduction of 10- (2-methoxycarbonylethyl) -2-trifluoromethyl-10H-phenothiazine, while four deuterium atoms were incorporated into the piperazine ring by reduction of 10-[3-(3,5-dioxo-1-piperazinyl)propyl]-2-trifluoromethyl-10H-pheno thiazine. The latter reduction gave the d4-labeled N-deshydroxyethyl metabolite of fluphenazine.

  4. The antibody approach of labeling blood cells

    International Nuclear Information System (INIS)

    Srivastava, S.C.

    1992-01-01

    Although the science of blood cell labeling using monoclonal antibodies directed against specific cellular antigens is still in its early stages, considerable progress has recently been accomplished in this area. The monoclonal antibody approach offers the promise of greater selectivity and enhanced convenience since specific cell types can be labeled in vivo, thus eliminating the need for complex and damaging cell separation procedures. This article focuses on these developments with primary emphasis on antibody labeling of platelets and leukocytes. The advantages and the shortcomings of the recently reported techniques are critically assessed and evaluated

  5. Labelling of bacteria with indium chelates

    International Nuclear Information System (INIS)

    Kleinert, P.; Pfister, W.; Endert, G.; Sproessig, M.

    1985-01-01

    The indium chelates were prepared by reaction of radioactive indiumchloride with 10 μg oxine, 15 μg tropolone and 3 mg acetylacetone, resp. The formed chelates have been incubated with 10 9 germs/ml for 5 minutes, with labelling outputs from 90 to 95%. Both gram-positive (Streptococcus, Staphylococcus) and gram-negative bacteria (Escherichia coli) can be labelled. The reproductive capacity of the bacteria was not impaired. The application of indium labelled bacteria allows to show the distribution of microorganisms within the living organism and to investigate problems of bacterial adherence. (author)

  6. Do European consumers use nutrition labels?

    DEFF Research Database (Denmark)

    Wills, Josephine M.; Grunert, Klaus G.; Celemín, Laura Fernández

    2009-01-01

    Nutrition labelling on food packages becomes more and more widespread in the European Union. Such information is not compulsory, unless a nutrition or health claim is made. However, how do consumers use nutrition information? Two European studies are currently assessing whether nutrition...... information on food labels is exerting an effect on healthy food choices among consumers. Based for the first time on in-store observations and interviews, these studies give a real-life insight into consumers' shopping behaviours. The major outcomes to date are that most European consumers have reasonable...... knowledge about nutrition and are able to use nutrition labels to identify healthier products within a category....

  7. Reductive methods for isotopic labeling of antibiotics

    International Nuclear Information System (INIS)

    Champney, W.S.

    1989-01-01

    Methods for the reductive methylation of the amino groups of eight different antibiotics using 3 HCOH or H 14 COH are presented. The reductive labeling of an additional seven antibiotics by NaB 3 H 4 is also described. The specific activity of the methyl-labeled drugs was determined by a phosphocellulose paper binding assay. Two quantitative assays for these compounds based on the reactivity of the antibiotic amino groups with fluorescamine and of the aldehyde and ketone groups with 2,4-dinitrophenylhydrazine are also presented. Data on the cellular uptake and ribosome binding of these labeled compounds are also presented

  8. The antibody approach of labeling blood cells

    Energy Technology Data Exchange (ETDEWEB)

    Srivastava, S.C.

    1991-12-31

    Although the science of blood cell labeling using monoclonal antibodies directed against specific cellular antigens is still in its early stages, considerable progress has recently been accomplished in this area. The monoclonal antibody approach offers the promise of greater selectivity and enhanced convenience since specific cell types can be labeled in vivo, thus eliminating the need for complex and damaging cell separation procedures. This article focuses on these developments with primary emphasis on antibody labeling of platelets and leukocytes. The advantages and the shortcomings of the recently reported techniques are criticality assessed and evaluated.

  9. The antibody approach of labeling blood cells

    Energy Technology Data Exchange (ETDEWEB)

    Srivastava, S.C.

    1991-01-01

    Although the science of blood cell labeling using monoclonal antibodies directed against specific cellular antigens is still in its early stages, considerable progress has recently been accomplished in this area. The monoclonal antibody approach offers the promise of greater selectivity and enhanced convenience since specific cell types can be labeled in vivo, thus eliminating the need for complex and damaging cell separation procedures. This article focuses on these developments with primary emphasis on antibody labeling of platelets and leukocytes. The advantages and the shortcomings of the recently reported techniques are criticality assessed and evaluated.

  10. The antibody approach of labeling blood cells

    Energy Technology Data Exchange (ETDEWEB)

    Srivastava, S.C.

    1992-12-31

    Although the science of blood cell labeling using monoclonal antibodies directed against specific cellular antigens is still in its early stages, considerable progress has recently been accomplished in this area. The monoclonal antibody approach offers the promise of greater selectivity and enhanced convenience since specific cell types can be labeled in vivo, thus eliminating the need for complex and damaging cell separation procedures. This article focuses on these developments with primary emphasis on antibody labeling of platelets and leukocytes. The advantages and the shortcomings of the recently reported techniques are critically assessed and evaluated.

  11. The antibody approach of labeling blood cells

    International Nuclear Information System (INIS)

    Srivastava, S.C.

    1991-01-01

    Although the science of blood cell labeling using monoclonal antibodies directed against specific cellular antigens is still in its early stages, considerable progress has recently been accomplished in this area. The monoclonal antibody approach offers the promise of greater selectivity and enhanced convenience since specific cell types can be labeled in vivo, thus eliminating the need for complex and damaging cell separation procedures. This article focuses on these developments with primary emphasis on antibody labeling of platelets and leukocytes. The advantages and the shortcomings of the recently reported techniques are criticality assessed and evaluated

  12. SAIL--stereo-array isotope labeling.

    Science.gov (United States)

    Kainosho, Masatsune; Güntert, Peter

    2009-11-01

    Optimal stereospecific and regiospecific labeling of proteins with stable isotopes enhances the nuclear magnetic resonance (NMR) method for the determination of the three-dimensional protein structures in solution. Stereo-array isotope labeling (SAIL) offers sharpened lines, spectral simplification without loss of information and the ability to rapidly collect and automatically evaluate the structural restraints required to solve a high-quality solution structure for proteins up to twice as large as before. This review gives an overview of stable isotope labeling methods for NMR spectroscopy with proteins and provides an in-depth treatment of the SAIL technology.

  13. Labelling of castor oil for myocardial study

    International Nuclear Information System (INIS)

    Hallaba, E.; Al-Suhybani, A.; Zaki, F.S.; Abdullah, M.E.

    1985-01-01

    The labelling of castor oil, hydrolyzed castor oil and oleic acid by iodine monochloride and chloramine-T was investigated. The effect of iodinating agent and concentration of castor oil on labelling yield was studied. A comparative pharmacological study with analog aliphatic acids was carried out. Castor oil labelled with iodine monochloride concentrates in heart and liver in good proportion, better than other natural fatty acids and nearly equal to analog fatty acids. Infrared study revealed that the OH group in ricinoleic acid may protect the sup(125)I added across the double bond with minor changes in biochemical properties causing better extraction by muscle of the heart. (author)

  14. 101 labeled brain images and a consistent human cortical labeling protocol

    Directory of Open Access Journals (Sweden)

    Arno eKlein

    2012-12-01

    Full Text Available We introduce the Mindboggle-101 dataset, the largest and most complete set of free, publicly accessible, manually labeled human brain images. To manually label the macroscopic anatomy in magnetic resonance images of 101 healthy participants, we created a new cortical labeling protocol that relies on robust anatomical landmarks and minimal manual edits after initialization with automated labels. The Desikan-Killiany-Tourville (DKT protocol is intended to improve the ease, consistency, and accuracy of labeling human cortical areas. Given how difficult it is to label brains, the Mindboggle-101 dataset is intended to serve as brain atlases for use in labeling other brains, as a normative dataset to establish morphometric variation in a healthy population for comparison against clinical populations, and contribute to the development, training, testing, and evaluation of automated registration and labeling algorithms. To this end, we also introduce benchmarks for the evaluation of such algorithms by comparing our manual labels with labels automatically generated by probabilistic and multi-atlas registration-based approaches. All data and related software and updated information are available on the http://www.mindboggle.info/data/ website.

  15. 101 Labeled Brain Images and a Consistent Human Cortical Labeling Protocol

    Science.gov (United States)

    Klein, Arno; Tourville, Jason

    2012-01-01

    We introduce the Mindboggle-101 dataset, the largest and most complete set of free, publicly accessible, manually labeled human brain images. To manually label the macroscopic anatomy in magnetic resonance images of 101 healthy participants, we created a new cortical labeling protocol that relies on robust anatomical landmarks and minimal manual edits after initialization with automated labels. The “Desikan–Killiany–Tourville” (DKT) protocol is intended to improve the ease, consistency, and accuracy of labeling human cortical areas. Given how difficult it is to label brains, the Mindboggle-101 dataset is intended to serve as brain atlases for use in labeling other brains, as a normative dataset to establish morphometric variation in a healthy population for comparison against clinical populations, and contribute to the development, training, testing, and evaluation of automated registration and labeling algorithms. To this end, we also introduce benchmarks for the evaluation of such algorithms by comparing our manual labels with labels automatically generated by probabilistic and multi-atlas registration-based approaches. All data and related software and updated information are available on the http://mindboggle.info/data website. PMID:23227001

  16. [Enterococcal endocarditis: a multicenter study of 76 cases].

    Science.gov (United States)

    Martínez-Marcos, Francisco Javier; Lomas-Cabezas, José Manuel; Hidalgo-Tenorio, Carmen; de la Torre-Lima, Javier; Plata-Ciézar, Antonio; Reguera-Iglesias, José María; Ruiz-Morales, Josefa; Márquez-Solero, Manuel; Gálvez-Acebal, Juan; de Alarcón-González, Arístides

    2009-12-01

    Although enterococci occupy the third position among microorganisms producing infectious endocarditis (IE) following streptococci and Staphylococcus aureus, few multicenter studies have provided an in-depth analysis of enterococcal IE. Description of the characteristics of 76 cases of enterococcal left-sided infectious endocarditis (LSIE) (native: 59, prosthetic: 17) retrieved from the database of the Cardiovascular Infections Study Group of the Andalusian Society of Infectious Diseases, with emphasis on the comparison with non-enterococcal LSIE. Enterococci were the causal agent in 76 of the 696 episodes of LSIE (11%). Compared with non-enterococcal LSIE, enterococcal LSIE was more commonly seen in patients older than 65 (47.4% vs. 27.6%, P<0.0005), and those with chronic diseases (75% vs. 54.6%, P<0.001), calcified valves (18.6% vs. 10%, P<0.05), and previous urinary (30.3% vs. 2.1%, P<0.00001) or abdominal (10.5% vs. 3.1%, P<0.01) infections, and produced a higher rate of relapses (6.6% vs. 2.3%, P<0.05). Enterococcal LSIE was associated with fewer peripheral vascular or skin manifestations (14.5% vs. 27.1%, P<0.05) and fewer immunological phenomena (10.5% vs. 24%, P<0.01). Among the total of patients with enterococcal LSIE, 36.8% underwent valve surgery during hospitalization. In-hospital mortality was 32.9% for enterococcal LSIE, 9.3% for viridans group streptococci (VGS) LSIE and 48.6% for S. aureus LSIE (enterococci vs VGS: P<0.0001; enterococci vs S. aureus: P=0.02). Enterococcal LSIE patients treated with the combination of a penicillin or vancomycin plus an aminoglycoside (n=60) and those treated with ampicillin plus ceftriaxone (n=6) showed similar in-hospital mortality (26.7% vs 33.3%, P=0.66). High-level resistance to gentamicin was detected in 5 of 38 episodes of enterococcal LSIE (13.1%). Enterococcal LSIE appears in patients with well-defined clinical characteristics, and causes few peripheral vascular or skin manifestations and few immunological

  17. Management of Pneumothorax in Emergency Medicine Departments: Multicenter Trial

    Science.gov (United States)

    Ince, Abdulkadir; Ozucelik, Dogac Niyazi; Avci, Akkan; Nizam, Ozgur; Dogan, Halil; Topal, Mehmet Ali

    2013-01-01

    Background: Pneumothorax is common and life-threatening clinical condition which may require emergency treatment in Emergency Medicine Departments. Objectives: We aimed to reveal the epidemiological analysis of the patients admitted to the Emergency Department with pneumothorax. Material and Methods: This case-control and multi-center study was conducted in the patients treated with the diagnosis of pneumothorax between 01.01.2010-31.12.2010. Patient data were collected from hospital automation system. According to the etiology of the pneumothorax, study groups were arranged like spontaneous pneumothorax and traumatic pneumothorax. Results: 82.2% (n = 106) of patients were male and 17.8% (n = 23) of patients were female and mean age were 31.3 ± 20,2 (Minimum: 1, Maximum: 87). 68.2% (n = 88) of patients were spontaneous pneumothorax (61.36%, n=79 were primary spontaneous pneumothorax) and 31.8% (n = 41) of patients were traumatic pneumothorax (21.95% were iatrogenic pneumothorax). Main complaint is shortness of breath (52.3%, n=67) and 38% (n=49) of patients were smokers. Posteroanterior (PA) Chest X-Ray has been enough for 64.3% (n = 83) of the patients' diagnosis. Tube thoracostomy is applied to 84.5% (n = 109) of patients and surgery is applied to 9.3% (n = 12) of patients and 6.2% (n = 8) of patients were discharged with conservative treatment. Spontaneous pneumothorax showed statistically significant high recurrence compared with traumatic pneumothorax (P = 0.007). 4.65% of (n = 6) patients died. The average age of those who died (9.3 ± 19.9), statistically were significantly lower the mean age of living patients (32.4 ± 19.7) (t test, P = 0,006). 83.33% of the patients who died were neonatals and in the 0-1 years age group, and five of these patients were secondary spontaneous pneumothorax, and one of these patients were iatrogenic pneumothorax due to mechanical ventilation. Conclusions: Pneumothorax in adults can be treated by tube thoracostomy or

  18. Study protocol for a multicenter investigation of reablement in Norway.

    Science.gov (United States)

    Langeland, Eva; Langland, Eva; Tuntland, Hanne; Førland, Oddvar; Aas, Eline; Folkestad, Bjarte; Jacobsen, Frode F; Kjeken, Ingvild

    2015-09-15

    Reablement is a promising new rehabilitation model, which is being implemented in some Western countries to meet current and future needs for home-based services. There is a need for further investigation of the effects of reablement among community-dwelling adults in terms of clinical and economic outcomes. This study will investigate the effectiveness of reablement in home-dwelling adults compared with standard treatment in terms of daily activities, physical functioning, health-related quality of life, coping, mental health, use of health care services, and costs. The study is a multicenter controlled trial. In total, 44 Norwegian municipalities will participate, including eight municipalities as a control group. For three municipalities with two zones, one will be assigned to the control group and the other to the intervention group. The experimental group will be offered reablement and the control group standard treatment. The sample will comprise approximately 750 participants. People will be eligible if they are home-dwelling adults, understand Norwegian, and have functional decline. Participants will be assessed at baseline, and after 10 weeks, 6 months, and 12 months. The primary outcome will be activity and participation measured by the Canadian Occupational Performance Measure. Physical functioning will be measured by the Short Physical Performance Battery and health-related quality of life by the European Quality of Life Scale. Coping will be measured by the Sense of Coherence questionnaire and mental health by the Mental Health Continuum Short Form. Costs will be generated based on registered working hours in different professions. Data analyses will be performed according to intention to treat. Univariate analysis of covariance will be used to investigate differences between the groups at baseline and the end of intervention. The data will be organized into two levels using a multilevel structure, i.e., individuals and municipalities, which will be

  19. A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India.

    Science.gov (United States)

    Chandra, Praveen; Kumar, Tarun

    2014-01-01

    A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India. 1. To study the MACE and in stent and In-segment Loss at Six Months (in a pre selected group of 50 patients). 1. Clinical and procedural success. This is a prospective, open label, single-arm, multicenter (16 sites), post marketing observational study enrolling patients implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) in routine clinical practice in India. A total of 200 Patients of coronary Artery Disease (CAD) implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) were enrolled. Clinical assessments were done at 30 days, 180 days and at 1, 2 years either telephonically or office visit. A cohort of 50 pre-selected patients were followed up for angiographic evaluation at 180 days. MACE at 12 month of follow up was 1.71%.Late lumen loss, in segment was 0.14 and in stent was 0.10 mm at 6 month of follow-up. TLR was required only in 2 patients. Superia stent is as safe as other biodegradable polymer stent in the market and time has come for biodegradable polymer stent with thin struts. Copyright © 2014 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  20. Synthesis of deuterium-labelled diclofenac sodium

    International Nuclear Information System (INIS)

    Leroy, D.; Richard, J.; Godbillon, J.

    1993-01-01

    Dicolofenac sodium labelled with deuterium in the phenylacetic ring was prepared from [ 2 H 5 ]-bromobenzene in a six-step reaction. It was found to be suitable for use in pharmacokinetic and bioavailability studies in man. (Author)

  1. Problems of Usage Labelling in English Lexicography*

    African Journals Online (AJOL)

    ancies in the contextual usage labelling in the dictionaries were established and are discussed. ..... Likewise, the noun vagrant meaning 'a person who has no job .... tions: Proceedings of the 36th Conference of the American Translators ...

  2. Read the Label First: Protect Your Pets

    Science.gov (United States)

    Learn about the importance of reading pet products labels before purchasing and using any product to insure the safety of your pets. Find tips for ways to reduce the changes of pets accessing potentially dangerous products.

  3. Read the Label First! Protect Your Household

    Science.gov (United States)

    ... and pesticides could harm children, pets, or the environment if not used and stored correctly. Choose a product that is labeled for your specific pest. EPA encourages consumers to consider using EPA-registered ...

  4. 40 CFR 211.104 - Label content.

    Science.gov (United States)

    2010-07-01

    ... regulations that will be published under this part; (c) Comparative acoustic rating information, which EPA... number or type identification; (f) The phrase “Federal law prohibits removal of this label prior to...

  5. Comparison of international food allergen labeling regulations.

    Science.gov (United States)

    Gendel, Steven M

    2012-07-01

    Food allergy is a significant public health issue worldwide. Regulatory risk management strategies for allergic consumers have focused on providing information about the presence of food allergens through label declarations. A number of countries and regulatory bodies have recognized the importance of providing this information by enacting laws, regulations or standards for food allergen labeling of "priority allergens". However, different governments and organizations have taken different approaches to identifying these "priority allergens" and to designing labeling declaration regulatory frameworks. The increasing volume of the international food trade suggests that there would be value in supporting sensitive consumers by harmonizing (to the extent possible) these regulatory frameworks. As a first step toward this goal, an inventory of allergen labeling regulations was assembled and analyzed to identify commonalities, differences, and future needs. Published by Elsevier Inc.

  6. 40 CFR 763.171 - Labeling requirements.

    Science.gov (United States)

    2010-07-01

    ... plastic, paper, metal, or other durable substances. Labels must be attached in such a manner that they... Act (15 U.S.C. 2605) as of (insert effective date of ban on distribution in commerce). Distribution of...

  7. How to Read a Nutrition Facts Label

    Medline Plus

    Full Text Available ... Teens Teens site Sitio para adolescentes Body Mind Sexual Health Food & Fitness Diseases & Conditions Infections Drugs & Alcohol ... Food Labels Healthy Food Shopping If My Child Has Food Allergies, What Should I Look for When ...

  8. How to Read a Nutrition Facts Label

    Medline Plus

    Full Text Available ... for Teens Teens site Sitio para adolescentes Body Mind Sexual Health Food & Fitness Diseases & Conditions Infections Drugs & ... topic for: Parents Kids Teens Keeping Portions Under Control Figuring Out Food Labels Healthy Food Shopping If ...

  9. 75 FR 49818 - APPLIANCE LABELING RULE

    Science.gov (United States)

    2010-08-16

    ... particular, this Notice contains revised Spanish language text in that sample label which reads ``Costo Estimado Anual de Energ[iacute]a'' instead of ``Costo Anual Estimado;'' ``de la tarifa'' instead of ``del...

  10. Isotopic labelling with carbon-14 and tritium

    International Nuclear Information System (INIS)

    Evans, E.A.

    1980-01-01

    In this paper general methods of isotopic labelling with 14 C and with 3 H are briefly reviewed with special attention to examples of compounds likely to be of wide interest in biological research. (author)

  11. Evaluation of three methods of platelet labelling

    International Nuclear Information System (INIS)

    Mortelmans, L.; Verbruggen, A.; Roo, M. de; Vermylen, J.

    1986-01-01

    The study of the kinetics of labelled platelets makes sense only when the platelets preserve their viability after separation and labelling. The separation and labelling procedures described in the manual of two producers of 111 In-oxinate (Amersham, Mallinckrodt) have been evaluated by in vitro aggregation tests. The method of Mallinckrodt diminished the aggregation capacities of the thrombocytes. The labelled platelets with normal in vitro aggregation response (Amersham) were tested in vivo in 11 patients who underwent peripheral bypass surgery. The platelet half-life and the platelet accumulation on bypass grafts were checked one week post-operatively. Because of the poor in vivo response of both methods (exponential half-life curve and bad graft visualization), a third method based on that described by W.A. Heaton et al. 1979 was optimized in the authors' laboratory with good in vitro and in vivo results in 12 patients. (author)

  12. Evaluation of three methods of platelet labelling.

    Science.gov (United States)

    Mortelmans, L; Verbruggen, A; De Roo, M; Vermylen, J

    1986-07-01

    The study of the kinetics of labelled platelets makes sense only when the platelets preserve their viability after separation and labelling. The separation and labelling procedures described in the manual of two producers of 111In-oxinate (Amersham, Mallinckrodt) have been evaluated by in vitro aggregation tests. The method of Mallinckrodt diminished the aggregation capacities of the thrombocytes. The labelled platelets with normal in vitro aggregation response (Amersham) were tested in vivo in 11 patients who underwent peripheral bypass surgery. The platelet half-life and the platelet accumulation on bypass grafts were checked one week post-operatively. Because of the poor in vivo response of both methods (exponential half-life curve and bad graft visualization), a third method was optimized in our laboratory with good in vitro and in vivo results in 12 patients.

  13. How to Read a Nutrition Facts Label

    Medline Plus

    Full Text Available ... Kids site Sitio para niños How the Body Works Puberty & Growing Up Staying Healthy Staying Safe Recipes & ... Out Food Labels Healthy Food Shopping If My Child Has Food Allergies, What Should I Look for ...

  14. How to Read a Nutrition Facts Label

    Medline Plus

    Full Text Available ... Parents site Sitio para padres General Health Growth & Development Infections Diseases & Conditions Pregnancy & Baby Nutrition & Fitness Emotions & ... Out Food Labels Healthy Food Shopping If My Child Has Food Allergies, What Should I Look for ...

  15. 21 CFR 1271.250 - Labeling controls.

    Science.gov (United States)

    2010-04-01

    ..., AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.250 Labeling controls. (a... available for distribution is accompanied by documentation of the donor eligibility determination as...

  16. Valuing labelling attributes with hedonic price analysis:

    DEFF Research Database (Denmark)

    Steiner, Bodo

    2004-01-01

    The market share of New World wines sold in many European countries has increased dramatically over the past decade. More aggressive marketing, together with a more distinct and recognizable labeling scheme, are often regarded as the keys to the marketing success of these new wines. This article...... employs hedonic price analysis to identify the values that marketers and consumers place on the information carried by the label of Australian wines in the British wine retail market. Although many grape varieties are given a highly distinct valuation by market participants, our results also suggest...... that consumers consider regions jointly with grape varieties as proxies for brands. This contrasts with the general observation that grape varietal labeling is the distinctive feature of New World wines. Marketing implications are examined by considering the revenue impact of changes in labeling at the retail...

  17. 76 FR 79057 - Appliance Labeling Rule

    Science.gov (United States)

    2011-12-21

    ... Part 305 Advertising, Energy conservation, Household appliances, Labeling, Reporting and recordkeeping... emitting diode (OLED) means a thin-film light- emitting device that typically consists of a series of...

  18. How to Read a Nutrition Facts Label

    Medline Plus

    Full Text Available ... Feelings Expert Answers Q&A Movies & More for Teens Teens site Sitio para adolescentes Body Mind Sexual Health ... choices. More on this topic for: Parents Kids Teens Keeping Portions Under Control Figuring Out Food Labels ...

  19. Two efficient label-equivalence-based connected-component labeling algorithms for 3-D binary images.

    Science.gov (United States)

    He, Lifeng; Chao, Yuyan; Suzuki, Kenji

    2011-08-01

    Whenever one wants to distinguish, recognize, and/or measure objects (connected components) in binary images, labeling is required. This paper presents two efficient label-equivalence-based connected-component labeling algorithms for 3-D binary images. One is voxel based and the other is run based. For the voxel-based one, we present an efficient method of deciding the order for checking voxels in the mask. For the run-based one, instead of assigning each foreground voxel, we assign each run a provisional label. Moreover, we use run data to label foreground voxels without scanning any background voxel in the second scan. Experimental results have demonstrated that our voxel-based algorithm is efficient for 3-D binary images with complicated connected components, that our run-based one is efficient for those with simple connected components, and that both are much more efficient than conventional 3-D labeling algorithms.

  20. Multiple tag labeling method for DNA sequencing

    Science.gov (United States)

    Mathies, R.A.; Huang, X.C.; Quesada, M.A.

    1995-07-25

    A DNA sequencing method is described which uses single lane or channel electrophoresis. Sequencing fragments are separated in the lane and detected using a laser-excited, confocal fluorescence scanner. Each set of DNA sequencing fragments is separated in the same lane and then distinguished using a binary coding scheme employing only two different fluorescent labels. Also described is a method of using radioisotope labels. 5 figs.

  1. Impact of Food Labeling on Consumer Behavior

    OpenAIRE

    Todua Nugzar

    2017-01-01

    The current study evaluates the development and perspective implication of social marketing interventions for empowering healthy life and well-being of the population in Georgia. The objective of the research is to analyze the impact of food labeling for healthy behavior change of Georgian consumers. The study revealed the strong correlation between awareness and education of consumer on food labeling and healthy behavior changing. One of the important factors of chang...

  2. Indirect labeling of proteins with radioiodine

    International Nuclear Information System (INIS)

    Araujo, Elaine Bortoleti de; Lavinas, Tatiana; Muramoto, Emiko; Pereira, Nilda P.S. de; Silva, Constancia P.G.; Tavares, Leoberto C.

    2000-01-01

    A procedure is described for the radioiodination of proteins using an iodinated derivative of N succinimidyl 3-(tri-n-butylstannyl)benzoate (ATE), previously described by Zalutsky. ATE was obtained in a high pure form and the iodination has been performed with 131-Iodine in 70-80% yield. Protein labeling studies performed with human IgG indicate that the ATE intermediate is an important alternative to conventional labeling methods. (author)

  3. Radioactive labelling of alkaloids with morphine skeleton

    International Nuclear Information System (INIS)

    Toth, Geza; Sirokman, Ferenc

    1985-01-01

    Results achieved by the sup(14)C, sup(125)I and sup(3)H labelling of alkaloids with morphine skeleton for kinetic, receptor, metabolims and pharmacological investigations are summarized and evaluated. The methods for the preparation of sup(3)H labelled dihydromorphine, dihydroethylmorphine, dihydrocodeine, naloxone and naloxazone are described. The compounds have higher specific molar activity than those referred to in literature which makes them suitable for a number of investigations. (author)

  4. Stability of rhenium-188 labeled antibody

    International Nuclear Information System (INIS)

    Lim, B. K.; Jung, J. M.; Jung, J. K.; Lee, D. S.; Lee, M. C.

    1999-01-01

    For clinical application of beta-emitter labeled antibody, high specific activity is important. Carrier-free Re-188 from W-188/Re-188 generator is an ideal radionuclide for this purpose. However, low stability of Re-188 labeled antibody, especially in high specific activity, due to radiolytic decomposition by high energy (2.1 MeV) beta ray was problem. We studied the stability of Re-188 labeled antibody, and stabilizing effect of several nontoxic radical-quenching agents. Pre-reduced monoclonal antibody (CEA79.4) was labeled with Re-188 by incubating with generator-eluted Re-188-perrhenate in the presence of stannous tartrate for 2 hr at room temperature. Radiochemical purity of each preparation was determined by chromatography (ITLC-SG/acetone, ITLC-SG/Umezawa, Whatman No.1/saline). Human serum albumin was added to the labeled antibodies(2%). Stability of Re-188-CEA79.4 was investigated in the presence of vitamin C, ethanol, or Tween 80 as radical-quenching agents. Specific activities of 4.29∼5.11 MBq/μg were obtained. Labeling efficiencies were 88±4%(n=12). Very low stability after removal of stannous tartrate from the preparation was observed. If stored after purging with N 2 , all the preparations were stable for 10 hr. However, if contacted with air, stability decreased. Perrhenate and Re-188-tartrate was major impurity in declined preparation (12∼47 and 9∼38% each, after 10 hr). Colloid-formation was not a significant problem in all cases. Addition of vitamin C stabilized the labeled antibodies either under N 2 or under air by reducing the formation of perrhenate. High specific activity Re-188 labeled antibody is unstable, especially, in the presence of oxygen. Addition of vitamin C increased the stability

  5. Cyclic labellings with constraints at two distances

    OpenAIRE

    Leese, R; Noble, S D

    2004-01-01

    Motivated by problems in radio channel assignment, we consider the vertex-labelling of graphs with non-negative integers. The objective is to minimise the span of the labelling, subject to constraints imposed at graph distances one and two. We show that the minimum span is (up to rounding) a piecewise linear function of the constraints, and give a complete specification, together with associated optimal assignments, for trees and cycles.

  6. Private label brand equity: a conceptual framework

    OpenAIRE

    Xara-Brasil, Duarte; Marreiros, Cristina; Dionísio, Andreia

    2012-01-01

    Trabalho apresentado na AMA/ACRA First Triennial Conference, 18-21 de abril de 2012, Seattle, USA This paper presents a conceptual framework to analyze private label brand equity in a retail context. Several authors proposed brand equity models as Aaker (1996), Keller (1993) and Yoo and Donthu (2001), and specific research has been done in retail industry (Jara & Cliquet, 2009), (Pappu & Quester, 2006). To study private label brand equity, we suggest a framework based on the Yo...

  7. Living labeling techniques of mesenchymal stem cells

    International Nuclear Information System (INIS)

    Dong Qingyu; Chen Li

    2007-01-01

    Mesenchymal stem cells (MSCs) are well known for their self-renew and multi- differentiation potentiality. With the transplantation of the MSCs which can promote the regeneration and repair of the injured tissue, a new route for the treatment of dieases is hopeful to be effective. To trace the distribution, migration, proliferation and differentiation of the implanted MSCs, there need effective labeling techniques, especially living labeling techniques. (authors)

  8. Manual airway labeling has limited reproducibility

    DEFF Research Database (Denmark)

    Petersen, Jens; Feragen, Aasa; Thomsen, Laura Hohwü

    Purpose: Quantitative airway assessment is often performed in specific branches to enable comparison of measurements between patients and over time. Little is known on the accuracy in locating these branches. We determined inter- and intra-observer agreement of manual labeling of segmental bronch...... disagreement in expert labeling, possibly reflecting large anatomical heterogeneity and changes with inspiration. Consistent airway measurement cannot be guaranteed based on manual localization....

  9. In vitro labeling receptor autoradiography: loss of label during ethanol dehydration and preparative procedures

    International Nuclear Information System (INIS)

    Kuhar, M.J.; Unnerstall, J.R.

    1982-01-01

    Slide-mounted tissue sections of brain were incubated with several reversibly binding [ 3 H]ligands to label receptors. Exposure of these labeled, mounted tissue sections to ethanol solutions for dehydration resulted in a substantial loss of receptor bound ligands in all cases, even when the tissues were fixed with formaldehyde vapors before exposure. Thus, serious problems can be introduced into in vitro labeling autoradiographic procedures by exposure of sections to aqueous or organic media. (Auth.)

  10. Comparison of ionisation properties of aetma-labeled saccharides with common labels

    OpenAIRE

    Partyka, J. (Jan); Foret, F. (František)

    2015-01-01

    We have tested (2-aminoethyl)trimethylammonium (AETMA) as a label for analysis of oligosaccharides by capillary electrophoresis with electrospray (ESI) mass spectrometry detection and compared its performance to taurine, 2-aminobenzoic acid, 2-aminobenzamide and 8-aminopyrene-1,3,6-trisulfonic acid. The AETMA-labeled saccharides were provided higher ionization signals in positive mode than native sodium or ammonium adducts and equal or higher signals than saccharides labeled by the more commo...

  11. Optimizing the definition of intrauterine growth restriction: the multicenter prospective PORTO Study.

    LENUS (Irish Health Repository)

    Unterscheider, Julia

    2013-04-01

    The objective of the Prospective Observational Trial to Optimize Pediatric Health in Intrauterine Growth Restriction (IUGR) (PORTO Study), a national prospective observational multicenter study, was to evaluate which sonographic findings were associated with perinatal morbidity and mortality in pregnancies affected by growth restriction, originally defined as estimated fetal weight (EFW) <10th centile.

  12. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM)

    NARCIS (Netherlands)

    Kemp, Samuel V.; Slebos, Dirk-Jan; Kirk, Alan; Kornaszewska, Malgorzata; Carron, Kris; Ek, Lars; Broman, Gustav; Hillerdal, Gunnar; Mal, Herve; Pison, Christophe; Briault, Amandine; Downer, Nicola; Darwiche, Kaid; Rao, Jagan; Huebner, Ralf-Harto; Ruwwe-Glosenkamp, Christof; Trosini-Desert, Valery; Eberhardt, Ralf; Herth, Felix J.; Derom, Eric; Malfait, Thomas; Shah, Pallav L.; Garner, Justin L.; ten Hacken, Nick H.; Fallouh, Hazem; Leroy, Sylvie; Marquette, Charles H.

    2017-01-01

    Rationale: Single-center randomized controlled trials of the Zephyr endobronchial valve (EBV) treatment have demonstrated benefit in severe heterogeneous emphysema. This is the first multicenter study evaluating this treatment approach. Objectives: To evaluate the efficacy and safety of Zephyr EBVs

  13. Peroral endoscopic myotomy for the treatment of achalasia: an international prospective multicenter study

    NARCIS (Netherlands)

    von Renteln, Daniel; Fuchs, Karl-Hermann; Fockens, Paul; Bauerfeind, Peter; Vassiliou, Melina C.; Werner, Yuki B.; Fried, Gerald; Breithaupt, Wolfram; Heinrich, Henriette; Bredenoord, Albert J.; Kersten, Jan F.; Verlaan, Tessa; Trevisonno, Michael; Rösch, Thomas

    2013-01-01

    Pilot studies have indicated that peroral endoscopic myotomy (POEM) might be a safe and effective treatment for achalasia. We performed a prospective, international, multicenter study to determine the outcomes of 70 patients who underwent POEM at 5 centers in Europe and North America. Three months

  14. A multicenter, long-term study on arrhythmias in children with Ebstein anomaly.

    NARCIS (Netherlands)

    Delhaas, T.; Sarvaas, G.J.; Rijlaarsdam, M.E.; Strengers, J.L.; Eveleigh, R.M.; Poulino, S.E.; Korte, C.L. de; Kapusta, L.

    2010-01-01

    To assess the prevalence, history, and treatment of arrhythmias, in particular preexcitation and Wolff-Parkinson-White (WPW) syndrome, in patients with Ebstein anomaly (EA) during childhood and adolescence, we performed a multicenter retrospective study of all consecutive live-born patients with EA,

  15. A Multicenter, Long-Term Study on Arrhythmias in Children with Ebstein Anomaly

    NARCIS (Netherlands)

    Delhaas, Tammo; Sarvaas, Gideon J. du Marchie; Rijlaarsdam, Marry E.; Strengers, Jan L.; Eveleigh, Rhona M.; Poulino, Sumayah E.; de Korte, Chris L.; Kapusta, Livia

    To assess the prevalence, history, and treatment of arrhythmias, in particular preexcitation and Wolff-Parkinson-White (WPW) syndrome, in patients with Ebstein anomaly (EA) during childhood and adolescence, we performed a multicenter retrospective study of all consecutive live-born patients with EA,

  16. Treatment of traumatic thoracolumbar spine fractures : A multicenter prospective randomized study of operative versus nonsurgical treatment

    NARCIS (Netherlands)

    Siebenga, Jan; Leferink, Vincent J. M.; Segers, Michiel J. M.; Elzinga, Matthijs J.; Bakker, Fred C.; Haarman, Henk J. Th. M.; Rommens, Pol M.; ten Duis, Henk-Jan; Patka, Peter

    2006-01-01

    Study Design. Multicenter prospective randomized trial. Objective. To test the hypotheses that thoracolumbar AO Type A spine fractures without neurologic deficit, managed with short-segment posterior stabilization will show an improved radiographic outcome and at least the same functional outcome as

  17. Who Donates Their Body to Science? An International, Multicenter, Prospective Study

    Science.gov (United States)

    Cornwall, Jon; Perry, Gary F.; Louw, Graham; Stringer, Mark D.

    2012-01-01

    The altruistic act of body donation provides a precious resource for both teaching and researching human anatomy. However, relatively little is known about individuals who donate their bodies to science (donors), and in particular whether donors in different geographical locations share similar characteristics. A multicenter prospective survey of…

  18. Sucralfate versus cimetidine in reflux esophagitis. A single-blind multicenter study

    NARCIS (Netherlands)

    Hameeteman, W.; v d Boomgaard, D. M.; Dekker, W.; Schrijver, M.; Wesdorp, I. C.; Tytgat, G. N.

    1987-01-01

    A single-blind randomized multicenter study was performed in 42 patients with endoscopically documented reflux esophagitis. Patients were randomly given 400 mg cimetidine q.i.d. or a suspension of 1 g sucralfate q.i.d. for a period of 8 weeks. Forty patients were evaluated after 8 weeks. Symptomatic

  19. Simplified Therapeutic Intervention Scoring System : The TISS-28 items - Results from a multicenter study

    NARCIS (Netherlands)

    Miranda, DR; deRijk, A; Schaufeli, W

    Objectives: To validate a simplified version of the Therapeutic Intervention Scoring System, the TISS-28, and to determine the association of TISS-28 with the time spent on scored and nonscored nursing activities. Design: Prospective, multicenter study. Setting: Twenty-two adult medical, surgical,

  20. A multi-center comparison of diagnostic methods for the biochemical evaluation of suspected mitochondrial disorders

    NARCIS (Netherlands)

    Rodenburg, R.J.T.; Schoonderwoerd, G.C.; Tiranti, V.; Taylor, R.W.; Rotig, A.; Valente, L.; Invernizzi, F.; Chretien, D.; He, L.; Backx, G.P.; Janssen, K.J.; Chinnery, P.F.; Smeets, H.J.M.; Coo, I.F. de; Heuvel, L.P. van den

    2013-01-01

    A multicenter comparison of mitochondrial respiratory chain and complex V enzyme activity tests was performed. The average reproducibility of the enzyme assays is 16% in human muscle samples. In a blinded diagnostic accuracy test in patient fibroblasts and SURF1 knock-out mouse muscle, each lab made