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Sample records for trial five-year results

  1. FIVE-YEAR RESULTS OF ADJUVANT RADIOTHER

    Science.gov (United States)

    Osa, Etin-Osa O.; DeWyngaert, Keith; Roses, Daniel; Speyer, James; Guth, Amber; Axelrod, Deborah; Kerimian, Maria Fenton; Goldberg, Judith D.; Formenti, Silvia C.

    2015-01-01

    Purpose/Objective A technique of prone breast radiotherapy delivered by a regimen of accelerated intensity modulated radiation therapy (IMRT) with a concurrent boost to the tumor bed, was developed at our institution. We report the five year results of this approach. Methods and Materials Between 2003–2006, 404 patients with Stage I–II breast cancer were prospectively enrolled into two consecutive protocols, institutional trials 03–30 and 05–181, that used the same regimen of 40.5Gy/15 fractions delivered to the index breast over 3 weeks, with a concomitant daily boost to the tumor bed of 0.5Gy (total dose=48Gy). All patients were treated after segmental mastectomy, had negative margins, and nodal assessment. Patients were set up prone: only if lung or heart volumes were in the field was a supine set-up attempted, and chosen if found to better spare these organs. Results 92% of patients were treated prone, 8% supine. 72% had stage I, 28% stage II invasive breast cancer. In-field lung volume ranged from 0 –228.27cc, mean: 19.65cc. In-field heart volume for left breast cancer patients ranged from 0–21.24cc, mean: 1.59cc. There was no heart in the field for right breast cancer patients. At a median follow-up of five years, the five-year cumulative incidence of isolated ipsilateral breast tumor recurrence was 0.82% (95% CI: 0.65–1.04). The five-year cumulative incidence of regional recurrence was 0.53% (95% CI:0.41–0.69) and the five-year overall cumulative death rate was 1.28% (95% CI: 0.48–3.38). 82% (95% CI: 77–85) of patients judged their final cosmetic result as excellent/good. Conclusions Prone accelerated IMRT with a concomitant boost results in excellent local control, optimal sparing of heart and lung, with good cosmesis. RTOG 10–05, a phase III, multi-institutional, randomized trial is ongoing and is evaluating the equivalence of a similar dose and fractionation approach to standard six weeks radiotherapy with a sequential boost. PMID

  2. Five-year safety and performance results from the Argus II Retinal Prosthesis System clinical trial

    Science.gov (United States)

    da Cruz, Lyndon; Dorn, Jessy D.; Humayun, Mark S.; Dagnelie, Gislin; Handa, James; Barale, Pierre-Olivier; Sahel, José-Alain; Stanga, Paulo E.; Hafezi, Farhad; Safran, Avinoam B.; Salzmann, Joel; Santos, Arturo; Birch, David; Spencer, Rand; Cideciyan, Artur V.; de Juan, Eugene; Duncan, Jacque L.; Eliott, Dean; Fawzi, Amani; Olmos de Koo, Lisa C.; Ho, Allen C.; Brown, Gary; Haller, Julia; Regillo, Carl; Del Priore, Lucian V.; Arditi, Aries; Greenberg, Robert J.

    2016-01-01

    Purpose The Argus® II Retinal Prosthesis System (Second Sight Medical Products, Inc., Sylmar, CA) was developed to restore some vision to patients blind from retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception due to end-stage RP. Design The study is a prospective, multicenter, single-arm, clinical trial. Within-patient controls included the non-implanted fellow eye and patients' native residual vision compared to their vision when using the System. Subjects There were 30 subjects in 10 centers in the U.S. and Europe. Methods The worse-seeing eye of blind patients was implanted with the Argus II System. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. Main Outcome Measures The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by three computer-based, objective tests. Secondary measures included functional vision performance on objectively-scored real-world tasks. Results Twenty-four out of 30 patients remained implanted with functioning Argus II Systems at 5 years post-implant. Only one additional serious adverse event was experienced since the 3-year time point. Patients performed significantly better with the System ON than OFF on all visual function tests and functional vision tasks. Conclusions The five-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada. PMID:27453256

  3. Prosthetic above-knee femoropopliteal bypass grafting: five-year results of a randomized trial.

    Science.gov (United States)

    Green, R M; Abbott, W M; Matsumoto, T; Wheeler, J R; Miller, N; Veith, F J; Money, S; Garrett, H E

    2000-03-01

    This trial was designed to identify factors affecting patency rates of primary prosthetic above-knee femoropopliteal bypass grafts at 5 years. A multi-institutional, prospective trial randomized 240 patients to compare patency rates of Gore-tex and Hemashield above-knee femoropopliteal bypass grafts at 5 years. Univariate comparisons of patency between levels of each prognostic variable were made with the Kaplan-Meier method. Variables that had a univariate P value less than.25 or those known to be important were submitted to a Cox regression analysis. The patient survival rate at 5 years was 59.4%. There were no differences in primary or secondary patency rates at 5 years between the two graft materials (primary, 45% vs 43% and secondary, 68% vs 68%). The risk for graft occlusion was significantly increased for patients younger than 65 years (2.1; P =.001) and for grafts with a diameter less than 7 mm (1.65; P =.0219). Variables with no apparent independent effect on patency rates were smoking status, runoff, diabetes mellitus, sex, presenting symptoms, and postoperative treatment with aspirin or Coumadin. Noninvasive test results were not predictive of subsequent graft function. Although the type of prosthetic used for above-knee femoropopliteal bypass grafts does not affect 5-year patency rates, age and graft size do influence results. These factors should be considered before a prosthetic bypass grafting procedure. Furthermore, these data should serve as a contemporary standard, with which evolving and conventional procedures can be compared.

  4. Does geographical variability influence five-year MACCE rates in the multicentre SYNTAX revascularisation trial?

    Science.gov (United States)

    Roy, Andrew K; Chevalier, Bernard; Lefèvre, Thierry; Louvard, Yves; Segurado, Ricardo; Sawaya, Fadi; Spaziano, Marco; Neylon, Antoinette; Serruys, Patrick A; Dawkins, Keith D; Kappetein, Arie Pieter; Mohr, Friedrich-Wilhelm; Colombo, Antonio; Feldman, Ted; Morice, Marie-Claude

    2017-09-20

    The use of multiple geographical sites for randomised cardiovascular trials may lead to important heterogeneity in treatment effects. This study aimed to determine whether treatment effects from different geographical recruitment regions impacted significantly on five-year MACCE rates in the SYNTAX trial. Five-year SYNTAX results (n=1,800) were analysed for geographical variability by site and country for the effect of treatment (CABG vs. PCI) on MACCE rates. Fixed, random, and linear mixed models were used to test clinical covariate effects, such as diabetes, lesion characteristics, and procedural factors. Comparing five-year MACCE rates, the pooled odds ratio (OR) between study sites was 0.58 (95% CI: 0.47-0.71), and countries 0.59 (95% CI: 0.45-0.73). By homogeneity testing, no individual site (X2=93.8, p=0.051) or country differences (X2=25.7, p=0.080) were observed. For random effects models, the intraclass correlation was minimal (ICC site=5.1%, ICC country=1.5%, p<0.001), indicating minimal geographical heterogeneity, with a hazard ratio of 0.70 (95% CI: 0.59-0.83). Baseline risk (smoking, diabetes, PAD) did not influence regional five-year MACCE outcomes (ICC 1.3%-5.2%), nor did revascularisation of the left main vs. three-vessel disease (p=0.241), across site or country subgroups. For CABG patients, the number of arterial (p=0.49) or venous (p=0.38) conduits used also made no difference. Geographic variability has no significant treatment effect on MACCE rates at five years. These findings highlight the generalisability of the five-year outcomes of the SYNTAX study.

  5. Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.

    Science.gov (United States)

    da Cruz, Lyndon; Dorn, Jessy D; Humayun, Mark S; Dagnelie, Gislin; Handa, James; Barale, Pierre-Olivier; Sahel, José-Alain; Stanga, Paulo E; Hafezi, Farhad; Safran, Avinoam B; Salzmann, Joel; Santos, Arturo; Birch, David; Spencer, Rand; Cideciyan, Artur V; de Juan, Eugene; Duncan, Jacque L; Eliott, Dean; Fawzi, Amani; Olmos de Koo, Lisa C; Ho, Allen C; Brown, Gary; Haller, Julia; Regillo, Carl; Del Priore, Lucian V; Arditi, Aries; Greenberg, Robert J

    2016-10-01

    The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP. Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II. Thirty participants in 10 centers in the United States and Europe. The worse-seeing eye of blind patients was implanted with the Argus II. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Secondary measures included functional vision performance on objectively scored real-world tasks. Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks. The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  6. Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Mendenhall, Nancy P., E-mail: menden@shands.ufl.edu [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Hoppe, Bradford S.; Nichols, Romaine C.; Mendenhall, William M.; Morris, Christopher G.; Li, Zuofeng; Su, Zhong [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Williams, Christopher R.; Costa, Joseph [Division of Urology, College of Medicine, University of Florida, Jacksonville, Florida (United States); Henderson, Randal H. [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States)

    2014-03-01

    Purpose: To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. Methods and Materials: A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years. Results: Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence. Conclusions: Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes.

  7. Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    International Nuclear Information System (INIS)

    Mendenhall, Nancy P.; Hoppe, Bradford S.; Nichols, Romaine C.; Mendenhall, William M.; Morris, Christopher G.; Li, Zuofeng; Su, Zhong; Williams, Christopher R.; Costa, Joseph; Henderson, Randal H.

    2014-01-01

    Purpose: To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. Methods and Materials: A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years. Results: Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence. Conclusions: Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes

  8. The effect of five years versus two years of specialised assertive intervention for first episode psychosis - OPUS II: study protocol for a randomized controlled trial

    DEFF Research Database (Denmark)

    Melau, Marianne; Jeppesen, Pia; Thorup, Anne

    2011-01-01

    . Based on our sample size estimation, 400 patients treated in OPUS for two years will be randomized to further three years of OPUS treatment versus standard treatment. The specialized assertive OPUS treatment consists of three core elements: assertive community treatment, psycho-educational family...... treatment, and social skills training. Discussion It has been hypothesized that there is a critical period from onset up to five years, which represents a window of opportunity where a long-term course can be influenced. Extending the specialized assertive OPUS treatment up to five years may allow...... the beneficial effects to continue beyond the high-risk period, through consolidation of improved social and functional outcome. Trial registration Clinical Trial.gov NCT00914238...

  9. Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series.

    Science.gov (United States)

    Adam, Gaelen P; Springs, Stacey; Trikalinos, Thomas; Williams, John W; Eaton, Jennifer L; Von Isenburg, Megan; Gierisch, Jennifer M; Wilson, Lisa M; Robinson, Karen A; Viswanathan, Meera; Middleton, Jennifer Cook; Forman-Hoffman, Valerie L; Berliner, Elise; Kaplan, Robert M

    2018-04-16

    We investigated whether information in ClinicalTrials.gov would impact the conclusions of five ongoing systematic reviews. We considered five reviews that included 495 studies total. Each review team conducted a search of ClinicalTrials.gov up to the date of the review's last literature search, screened the records using the review's eligibility criteria, extracted information, and assessed risk of bias and applicability. Each team then evaluated the impact of the evidence found in ClinicalTrials.gov on the conclusions in the review. Across the five reviews, the number of studies that had both a registry record and a publication varied widely, from none in one review to 43% of all studies identified in another. Among the studies with both a record and publication, there was also wide variability in the match between published outcomes and those listed in ClinicalTrials.gov. Of the 173 total ClinicalTrials.gov records identified across the five projects, between 11 and 43% did not have an associated publication. In the 14% of records that contained results, the new data provided in the ClinicalTrials.gov records did not change the results or conclusions of the reviews. Finally, a large number of published studies were not registered in ClinicalTrials.gov, but many of these were published before ClinicalTrials.gov's inception date of 2000. Improved prospective registration of trials and consistent reporting of results in ClinicalTrials.gov would help make ClinicalTrials.gov records more useful in finding unpublished information and identifying potential biases. In addition, consistent indexing in databases, such as MEDLINE, would allow for better matching of records and publications, leading to increased utility of these searches for systematic review projects.

  10. True fir spacing trials: 10-year results.

    Science.gov (United States)

    Robert O. Curtis

    2008-01-01

    Eighteen precommercial thinning trials were established in true fir-hemlock stands in the Olympic Mountains and the west side of the Cascade Range during the period 1987 through 1994. This paper updates a previous report, with results for the first 10 years after establishment. Results are given for (1) all trees, (2) the largest 80 per acre of any species, and (3)...

  11. Twenty-year-old results from a bottomland oak species comparison trial in western Kentucky

    Science.gov (United States)

    Randall J. Rousseau

    2008-01-01

    A 20-year-old trial of five bottomland oak species (cherrybark, Nuttall, pin, water, and willow oaks) located in western Kentucky showed little difference in survival and growth but considerable difference in form characteristics. Mortality was highest between ages 1 and 3 years during plantation establishment until tree-to-tree competition began increasing between the...

  12. Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer

    International Nuclear Information System (INIS)

    Fisher, B.; Bauer, M.; Margolese, R.

    1985-01-01

    In 1976 the authors began a randomized trial to evaluate breast conservation by a segmental mastectomy in the treatment of State I and II breast tumors less than or equal to 4 cm in size. The operation removes only sufficient tissue to ensure that margins of resected specimens are free of tumor. Women were randomly assigned to total mastectomy, segmental mastectomy alone, or segmental mastectomy followed by breast irradiation. All patients had auxillary dissections, and patients with positive nodes received chemotherapy. Life-tables estimates based on data from 1843 women indicated that treatment by segmental mastectomy, with or without breast irradiation, resulted in disease-free, distant-disease-free, and overall survival at five years that was no worse than that after total breast removal. In fact, disease-free survival after segmental mastectomy plus radiation was better than disease-free survival after total mastectomy, and overall survival after segmental mastectomy, with or without radiation, was better than overall survival after total mastectomy. A total of 92.3% of women treated with radiation remained free of breast tumor at five years, as compared with 72.1% of those receiving no radiation. Among patients with positive nodes 97.9% of women treated with radiation and 63.8% of those receiving no radiation remained tumor-free, although both groups received chemotherapy. They conclude that segmental mastectomy, followed by breast irradiation in all patients and adjuvant chemotherapy in women with positive nodes, is appropriate therapy for Stage I and II breast tumors less than or equal to 4 cm, provided that margins of resected specimens are free of tumor. 23 references, 4 figures, 6 tables

  13. Radiotherapy with or without hyperthermia in the treatment of superficial localized breast cancer: results from five randomized controlled trials

    International Nuclear Information System (INIS)

    Vernon, Clare C.; Hand, Jeffrey W.; Field, Stanley B.; Machin, David; Whaley, Jill B.; Zee, Jacoba van der; Putten, Wim L.J. van; Rhoon, Gerard C. van; Dijk, Jan D.P. van; Gonzalez, Dionisio Gonzalez; Liu, F.-F.; Goodman, Phyllis; Sherar, Michael

    1996-01-01

    Purpose: Claims for the value of hyperthermia as an adjunct to radiotherapy in the treatment of cancer have mostly been based on small Phase I or II trials. To test the benefit of this form of treatment, randomized Phase III trials were needed. Methods and Materials: Five randomized trials addressing this question were started between 1988 and 1991. In these trials, patients were eligible if they had advanced primary or recurrent breast cancer, and local radiotherapy was indicated in preference to surgery. In addition, heating of the lesions and treatment with a prescribed (re)irradiation schedule had to be feasible and informed consent was obtained. The primary endpoint of all trials was local complete response. Slow recruitment led to a decision to collaborate and combine the trial results in one analysis, and report them simultaneously in one publication. Interim analyses were carried out and the trials were closed to recruitment when a previously agreed statistically significant difference in complete response rate was observed in the two larger trials. Results: We report on pretreatment characteristics, the treatments received, the local response observed, duration of response, time to local failure, distant progression and survival, and treatment toxicity of the 306 patients randomized. The overall CR rate for RT alone was 41% and for the combined treatment arm was 59%, giving, after stratification by trial, an odds ratio of 2.3. Not all trials demonstrated an advantage for the combined treatment, although the 95% confidence intervals of the different trials all contain the pooled odds ratio. The greatest effect was observed in patients with recurrent lesions in previously irradiated areas, where further irradiation was limited to low doses. Conclusion: The combined result of the five trials has demonstrated the efficacy of hyperthermia as an adjunct to radiotherapy for treatment of recurrent breast cancer. The implication of these encouraging results is that

  14. Forty-five years of schizophrenia trials in Italy: a survey

    Directory of Open Access Journals (Sweden)

    Purgato Marianna

    2012-04-01

    Full Text Available Abstract Background Well-designed and properly executed randomized controlled trials (RCTs provide the best evidence on the efficacy of healthcare interventions. Mental health has a strong tradition of using trial to evaluate treatments, but the translation of research to clinical practice is not always easy. Even well-conducted trials do not necessarily address the needs of every day care and trials can reflect local needs and the specific culture in which they are undertaken. Generalizing results to other contexts can become problematic but these trials may, nevertheless, be very helpful within their own context. Moreover, pathways for drug approval can be different depending on local regulatory agencies. Local trials are helpful for decision-making in the region from which they come, but should not be viewed in isolation. National quantity and quality of trials may vary across nations. The aim of this study is to quantify trialing activity in Italy from 1948 until 2009 and to describe characteristics of these trials. In addition, we evaluated change over time in three keys aspects: sample size, follow-up duration, and number of outcomes. Methods We used the Cochrane Schizophrenia Group's register that contains 16,000 citations to 13,000 studies relating only to people with schizophrenia or schizophrenia-like illness. Randomized controlled trials and controlled clinical trials undertaken in Italy and involving pharmacological interventions were included. Results The original search identified 155 records of potentially eligible studies, 74 of which were excluded because do not meet inclusion criteria. A total of 81 studies were included in the analysis. The majority of trials were conducted in north Italy, and published in international journals between 1981 and 1995. The majority of studies (52 out of 81 used standardized diagnostic criteria for schizophrenia disorder. They were defined as randomized and used blind methods to administer

  15. Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX)

    Science.gov (United States)

    Cotton, S C; Boachie, C; Ramsay, C R; Krukowski, Z H; Heading, R C; Campbell, M K

    2013-01-01

    Objectives To determine the long term clinical effectiveness of laparoscopic fundoplication as an alternative to drug treatment for chronic gastro-oesophageal reflux disease (GORD). Design Five year follow-up of multicentre, pragmatic randomised trial (with parallel non-randomised preference groups). Setting Initial recruitment in 21 UK hospitals. Participants Responders to annual questionnaires among 810 original participants. At entry, all had had GORD for >12 months. Intervention The surgeon chose the type of fundoplication. Medical therapy was reviewed and optimised by a specialist. Subsequent management was at the discretion of the clinician responsible for care, usually in primary care. Main outcome measures Primary outcome measure was self reported quality of life score on disease-specific REFLUX questionnaire. Other measures were health status (with SF-36 and EuroQol EQ-5D questionnaires), use of antireflux medication, and complications. Results By five years, 63% (112/178) of patients randomised to surgery and 13% (24/179) of those randomised to medical management had received a fundoplication (plus 85% (222/261) and 3% (6/192) of those who expressed a preference for surgery and for medical management). Among responders at 5 years, 44% (56/127) of those randomised to surgery were taking antireflux medication versus 82% (98/119) of those randomised to medical management. Differences in the REFLUX score significantly favoured the randomised surgery group (mean difference 8.5 (95% CI 3.9 to 13.1), Preflux-related operations—most often revision of the wrap. Long term rates of dysphagia, flatulence, and inability to vomit were similar in the two randomised groups. Conclusions After five years, laparoscopic fundoplication continued to provide better relief of GORD symptoms than medical management. Adverse effects of surgery were uncommon and generally observed soon after surgery. A small proportion had re-operations. There was no evidence of long term adverse

  16. Five Year Results of US Intergroup/RTOG 9704 With Postoperative CA 19-9 {<=}90 U/mL and Comparison to the CONKO-001 Trial

    Energy Technology Data Exchange (ETDEWEB)

    Berger, Adam C., E-mail: adam.berger@jefferson.edu [Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States); Winter, Kathryn [RTOG Statistical Center, Philadelphia, Pennsylvania (United States); Hoffman, John P. [Fox Chase Cancer Center, Philadelphia, Pennsylvania (United States); Regine, William F. [University of Maryland Medical Systems, Baltimore, Maryland (United States); Abrams, Ross A. [Rush University Medical Center, Chicago, Illinois (United States); Safran, Howard [Division of Hematology/Oncology, The Miriam Hospital, Providence, Rhode Island (United States); Freedman, Gary M. [Fox Chase Cancer Center, Philadelphia, Pennsylvania (United States); Benson, Alan B. [Northwestern Memorial Hospital, Chicago, Illinois (United States); MacDonald, John [St. Vincent' s Comprehensive Cancer Center, New York, New York (United States); Willett, Christopher G. [Duke University Medical Center, Durham, North Carolina (United States)

    2012-11-01

    Purpose: Radiation Therapy Oncology Group (RTOG) trial 9704 was the largest randomized trial to use adjuvant chemoradiation therapy for patients with pancreatic cancer. This report analyzes 5-year survival by serum level of tumor marker CA 19-9 of {<=}90 vs >90 U/mL and compares results to the those of the CONKO-001 trial. Methods and Materials: CA 19-9 expression was analyzed as a dichotomized variable ({<=}90 vs >90 U/mL). Cox proportional hazard models were used to identify the impact of the CA 19-9 value on overall survival (OS). Actuarial estimates of OS were calculated using the Kaplan-Meier method. Results: Both univariate (hazard ratio [HR] = 3.2; 95% confidence interval [CI], 2.3-4.3, P<.0001) and multivariate (HR = 3.1; 95% CI, 2.2-4.2, P<.0001) analyses demonstrated a statistically significant decrease in OS for CA 19-9 serum level of {>=}90 U/mL. For patients in the gemcitabine (Gem) treatment arm with CA 19-9 <90 U/mL, median survival was 21 months. For patients with CA 19-9 {>=}90 U/mL, this number dropped to 10 months. In patients with pancreatic head tumors in the Gem treatment arm with RT quality assurance per protocol and CA 19-9 of <90 U/mL, median survival and 5-year rate were 24 months and 34%. In comparison, the median survival and 5-year OS rate for patients in the Gem arm of the CONKO trial were 22 months and 21%. Conclusions: This analysis demonstrates that patients with postresection CA 19-9 values {>=}90 U/mL had a significantly worse survival. Patients with pancreatic head tumors treated with Gem with CA 19-9 serum level of <90 U/mL and per protocol RT had favorable survival compared to that seen in the CONKO trial. CA 19-9 is a stratification factor for the current RTOG adjuvant pancreas trial (0848).

  17. Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma

    NARCIS (Netherlands)

    de Jong, Leo; Lafuma, Antoine; Aguadé, Anne-Sophie; Berdeaux, Gilles

    2011-01-01

    This study compared the efficacy of the EX-PRESS(®) glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery. Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS

  18. A Randomised Controlled Treatment Trial of Two Forms of Family Therapy in Adolescent Anorexia Nervosa: A Five-Year Follow-Up

    Science.gov (United States)

    Eisler, Ivan; Simic, Mima; Russell, Gerald F. M.; Dare, Christopher

    2007-01-01

    Background: There is growing evidence that family therapy is an effective treatment for adolescent anorexia nervosa. This study aimed to ascertain the long-term impact of two forms of outpatient family intervention previously evaluated in a randomised controlled trial (RCT). Method: A five-year follow-up was conducted on a cohort of 40 patients…

  19. Retropubic versus transobturator tension-free vaginal tape (TVT vs TVT-O): Five-year results of the Austrian randomized trial.

    Science.gov (United States)

    Tammaa, Ayman; Aigmüller, Thomas; Hanzal, Engelbert; Umek, Wolfgang; Kropshofer, Stephan; Lang, Peter F J; Ralph, George; Riss, Paul; Koelle, Dieter; Jundt, Katharina; Tamussino, Karl; Bjelic-Radisic, Vesna

    2018-01-01

    To compare outcomes of the retropubic versus the transobturator tension-free vaginal tape (TVT vs TVT-O) at 5 years. A total of 569 women undergoing surgery for primary stress incontinence were randomized to receive a retropubic or a transobturator tensionfree vaginal tape (TVT or TVT-O). Follow-up at 5 years included clinical examination, urodynamic studies and quality of life. The primary outcome measure was continence defined as a negative cough stress test at a volume of 300 mL. Secondary outcomes included urodynamic parameters, complications and quality of life.ClinicalTrials.gov (NCT 0041454). Three hundred and thirty-one patients (59%) were evaluated at 5 years (277 were seen, examined and completed questionnaires; 54 only completed questionnaires). No significant differences were seen in rates of a negative cough stress test (83% vs 76%, respectively), urodynamic parameters and complications. Quality-of-life improved significantly in both groups, without significant differences between the groups. Erosion rates were 5.2% and 4.5%, and reoperation rates were 4.1% and 3.2% respectively. At 5 years, subjective and objective results after TVT and TVT-O are stable and similar, without statistical significant differences between the procedures. Major long-term problems appear rare. © 2017 Wiley Periodicals, Inc.

  20. Results on safety research for five years (from fiscal year 1996 to 2000). A field of power reactors

    International Nuclear Information System (INIS)

    2001-10-01

    This safety research carried out by the Japan Nuclear Cycle Development Institute (JNC) for five years ranged from 1996 to 2000 fiscal year, was performed according to the safety research basic plan (from 1996 to 2000 fiscal year) established on March, 1996 (revised again on May, 2000). This report was arranged on a field on power reactors (all subjects on fields of advanced conversion reactor and a subject on power reactor in a field of seismic resistant and probability theoretical safety evaluation) by combining its research results for five years ranged from 1996 to 2000 fiscal year with general outlines on the safety research basic plan. Here were shown outlines on the safety research basic plan, aims and subjects on safety research at a field of power reactors, a list of survey sheets on safety research result, and survey sheets on safety research results. The survey sheets containing research field, title, organization, researcher name, researching period, names of cooperative organization, using facilities, research outline, research results, established contents, application, and research trends, are ranged to 5 items on advanced conversion reactor, 29 items on high breeder reactor, 1 item on seismic resistance, and 5 items on probability theoretical safety evaluation. (G.K.)

  1. Publication and non-publication of drug trial results: a 10-year cohort of trials in Norwegian general practice.

    Science.gov (United States)

    Brænd, Anja Maria; Straand, Jørund; Jakobsen, Rune Bruhn; Klovning, Atle

    2016-04-11

    Previously, we identified a 10-year cohort of protocols from applications to the Norwegian Medicines Agency 1998-2007, consisting of 196 drug trials in general practice. The aim of this study was to examine whether trial results were published and whether trial funding and conflicts of interest were reported. Cohort study of trials with systematic searches for published results. Clinical drug trials in Norwegian general practice. We performed systematic literature searches of MEDLINE, Embase and CENTRAL to identify publications originating from each trial using characteristics such as test drug, comparator and patient groups as search terms. When no publication was identified, we contacted trial sponsors for information regarding trial completion and reference to any publications. We determined the frequency of publication of trial results and trial characteristics associated with publication of results. Of the 196 trials, 5 were never started. Of the remaining 191 trials, 71% had results published in a journal, 11% had results publicly available elsewhere and 18% of trials had no results available. Publication was more common among trials with an active comparator drug (χ(2) test, p=0.040), with a larger number of patients (total sample size≥median, p=0.010) and with a longer trial period (duration≥median, p=0.025). Trial funding was reported in 85% of publications and increased over time, as did reporting of conflicts of interest among authors. Among the 134 main journal articles from the trials, 60% presented statistically significant results for the investigational drug, and the conclusion of the article was favourable towards the test drug in 78% of papers. We did not identify any journal publication of results for 29% of the general practice drug trials. Trials with an active comparator, larger and longer trials were more likely to be published. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a

  2. Five years' experience of classical swine fever polymerase chain reaction ring trials in France.

    Science.gov (United States)

    Po, F; Le Dimna, M; Le Potier, M F

    2011-12-01

    Since 2004, the French National Reference Laboratory for classical swine fever (CSF) has conducted an annual proficiency test (PT) to evaluate the ability of local veterinary laboratories to perform real-time polymerase chain reaction (PCR) for CSF virus. The results of five years of testing (2004-2008) are described here. The PT was conducted under blind conditions on 20 samples. The same batch of samples was used for all five years. The number of laboratories that analysed the samples increased from four in 2004 to 13 in 2008. The results of the PT showed the following: cross-contamination between samples and deficiencies in RNA preparation can occur even in experienced laboratories; sample homogeneity should be checked carefully before selection; samples stored at-80 degrees C for several years remain stable; and poor shipment conditions do not damage the samples with regard to detection of CSF virus genome. These results will enable redesign of the panel to improve the overall quality of the PT, which will encourage laboratories to check and improve their PCR procedures and expertise. This is an excellent way to determine laboratory performance.

  3. Results on safety research for five years (from fiscal year 1996 to 2000). A field of nuclear fuel cycle

    International Nuclear Information System (INIS)

    2001-10-01

    This safety research carried out by the Japan Nuclear Cycle Development Institute (JNC) for five years ranged from fiscal year 1996 to 2000, was performed according to the safety research basic plan (from fiscal year 1996 to 2000) established on March, 1996 (revised again on May, 2000). This report was arranged on a field on nuclear fuel cycle (all subjects on fields of nuclear fuel facility, environmental radioactivity and radioactive wastes and a subject on nuclear fuel cycle in a field of seismic resistant and probabilistic safety assessment) by combining its research results for five years ranged from 1996 to 2000 fiscal year with general outlines on the safety research basic plan. Here were shown outlines on the safety research basic plan, aims and subjects on safety research at a field of nuclear fuel cycle, a list of survey sheets on safety research result, and survey sheets on safety research results. The survey sheets containing research field, title, organization, researcher name, researching period, names of cooperative organization, using facilities, research outline, research results, established contents, application, and research trends, are ranged to 21 items on nuclear fuel facility, 1 item on seismic resistance, 2 items on probabilistic safety assessment, 8 items on environmental radioactivity, and 20 items on radioactive wastes. (G.K.)

  4. Five-year results of vital pulp therapy in permanent molars with irreversible pulpitis: a non-inferiority multicenter randomized clinical trial.

    Science.gov (United States)

    Asgary, Saeed; Eghbal, Mohammad Jafar; Fazlyab, Mahta; Baghban, Alireza Akbarzadeh; Ghoddusi, Jamileh

    2015-03-01

    Previous reported results of up to 12 months as well as 24-month follow-ups revealed superior and equivalent treatment outcomes for vital pulp therapy (VPT) using calcium-enriched mixture cement (CEM) in comparison with root canal therapy (RCT) for mature molars with established irreversible pulpitis, respectively. Present non-inferiority multicenter randomized clinical trial assesses the final long-term (5-year) results as well as the effects of patients' age/gender and the presence of preoperative periapical lesion on the treatment outcomes. A total number of 407 patients were blindly allocated into two treatment groups [group 1 (VPT/CEM, n = 205) and group 2 (RCT, n = 202)] treated in 23 health-care centers by calibrated dentists. The treatment outcomes were assessed after 60 months. The 5-year results revealed no significant differences in the successes of both study arms (P = 0.29); a total number of 271 patients were available (~33 % were lost to follow-up). The patients' age/gender did not affect the outcomes; the presence of preoperative periapical lesion also did not implement a significant effect in both groups (P > 0.05). As an alternative for RCT, VPT/CEM can be considered as a valid treatment for vital mature permanent molars clinically diagnosed with irreversible pulpitis. Considering the favorable outcomes of 6- to 60-month follow-ups, as an evidence-based/simple/affordable/effective/biologic approach in cases of irreversible pulpitis, VPT/CEM is highly recommended for universal clinical practice.

  5. Vitamin E diffused highly cross-linked polyethylene in total hip arthroplasty at five years

    DEFF Research Database (Denmark)

    Nebergall, Audrey K; Greene, M. E.; Laursen, M B

    2017-01-01

    Aims: The objective of this five-year prospective, blinded, randomised controlled trial (RCT) was to compare femoral head penetration into a Vitamin E diffused highly cross-linked polyethylene (HXLPE) liner with penetration into a medium cross-linked polyethylene control liner using......, ArComXL. This is the longest-term RCT comparing the wear performance and clinical outcome of Vitamin E diffused HXLPE with a previous generation of medium cross-linked polyethylene....... radiostereometric analysis. Patients and Methods: Patients scheduled for total hip arthroplasty (THA) were randomised to receive either the study E1 (32 patients) or the control ArComXL polyethylene (35 patients). The median age (range) of the overall cohort was 66 years (40 to 76). Results: The five-year median...

  6. Five-year follow-up of harms and benefits of behavioral infant sleep intervention: randomized trial.

    Science.gov (United States)

    Price, Anna M H; Wake, Melissa; Ukoumunne, Obioha C; Hiscock, Harriet

    2012-10-01

    Randomized trials have demonstrated the short- to medium-term effectiveness of behavioral infant sleep interventions. However, concerns persist that they may harm children's emotional development and subsequent mental health. This study aimed to determine long-term harms and/or benefits of an infant behavioral sleep program at age 6 years on (1) child, (2) child-parent, and (3) maternal outcomes. Three hundred twenty-six children (173 intervention) with parent-reported sleep problems at age 7 months were selected from a population sample of 692 infants recruited from well-child centers. The study was a 5-year follow-up of a population-based cluster-randomized trial. Allocation was concealed and researchers (but not parents) were blinded to group allocation. Behavioral techniques were delivered over 1 to 3 individual nurse consultations at infant age 8 to 10 months, versus usual care. The main outcomes measured were (1) child mental health, sleep, psychosocial functioning, stress regulation; (2) child-parent relationship; and (3) maternal mental health and parenting styles. Two hundred twenty-five families (69%) participated. There was no evidence of differences between intervention and control families for any outcome, including (1) children's emotional (P = .8) and conduct behavior scores (P = .6), sleep problems (9% vs 7%, P = .2), sleep habits score (P = .4), parent- (P = .7) and child-reported (P = .8) psychosocial functioning, chronic stress (29% vs 22%, P = .4); (2) child-parent closeness (P = .1) and conflict (P = .4), global relationship (P = .9), disinhibited attachment (P = .3); and (3) parent depression, anxiety, and stress scores (P = .9) or authoritative parenting (63% vs 59%, P = .5). Behavioral sleep techniques have no marked long-lasting effects (positive or negative). Parents and health professionals can confidently use these techniques to reduce the short- to medium-term burden of infant sleep problems and maternal depression.

  7. Results of the gas carrier reliquefaction plant trial

    Directory of Open Access Journals (Sweden)

    Y. Fatyhov

    2007-12-01

    Full Text Available In the paper results of the gas carrier reliquefaction plant trial are considered. Safe transportation of liquefied gases is explained. The construction of the ship on trial is described. Designed parameters of the reliquefaction plant are presented. Heat gain into cargo tanks is obtained. Volumetric capacity, cooling capacity, volumetric efficiency and power consumption of the compressors are determined. Results of the main engine trial, diesel generator trial, reliquefaction plant trial, and calculations performed after wards are represented in five tables. The results obtained may be used for optimisation calculations of gas carriers’ reliquefaction plants.

  8. Stereotactic body radiotherapy for low-risk prostate cancer: five-year outcomes

    Directory of Open Access Journals (Sweden)

    King Christopher R

    2011-01-01

    Full Text Available Abstract Purpose Hypofractionated, stereotactic body radiotherapy (SBRT is an emerging treatment approach for prostate cancer. We present the outcomes for low-risk prostate cancer patients with a median follow-up of 5 years after SBRT. Method and Materials Between Dec. 2003 and Dec. 2005, a pooled cohort of 41 consecutive patients from Stanford, CA and Naples, FL received SBRT with CyberKnife for clinically localized, low-risk prostate cancer. Prescribed dose was 35-36.25 Gy in five fractions. No patient received hormone therapy. Kaplan-Meier biochemical progression-free survival (defined using the Phoenix method and RTOG toxicity outcomes were assessed. Results At a median follow-up of 5 years, the biochemical progression-free survival was 93% (95% CI = 84.7% to 100%. Acute side effects resolved within 1-3 months of treatment completion. There were no grade 4 toxicities. No late grade 3 rectal toxicity occurred, and only one late grade 3 genitourinary toxicity occurred following repeated urologic instrumentation. Conclusion Five-year results of SBRT for localized prostate cancer demonstrate the efficacy and safety of shorter courses of high dose per fraction radiation delivered with SBRT technique. Ongoing clinical trials are underway to further explore this treatment approach.

  9. Treatment of Visceral Aneurysm Using Multilayer Stent: Two-Year Follow-Up Results in Five Consecutive Patients

    Energy Technology Data Exchange (ETDEWEB)

    Balderi, Alberto, E-mail: balders@libero.it; Antonietti, Alberto, E-mail: antonietti.a@ospedale.cuneo.it; Pedrazzini, Fulvio, E-mail: pedrazzini.f@ospedale.cuneo.it; Sortino, Davide, E-mail: davide.sortino@hotmail.it; Vinay, Claudia, E-mail: claudia.vinay@gmail.com; Grosso, Maurizio, E-mail: grosso.m@ospedale.cuneo.it [AO Santa Croce e Carle Hospital, Department of Radiology (Italy)

    2013-10-15

    Purpose: The present study was performed to analyze the midterm results (five consecutive patients, 2-year follow-up) of the endovascular management of visceral artery aneurysms using the Cardiatis Multilayer Flow Modulator (CMFM) (Cardiatis, Isnes, Belgium), a self-expandable stent. Materials and Methods: From August 2009 to January 2011, we implanted five CMFMs in five patients (all men; mean age 73 years) to treat two common hepatic artery aneurysms, one celiac trunk aneurysm, one splenic artery aneurysm, and one superior mesenteric artery aneurysm (diameter 25-81 mm). The primary end point was technical success. The secondary end point was stent patency, absence of aneurysm rupture or reperfusion, and shrinking of the sac at 6-, 12-, and 24-month follow-up using computed tomography angiography. Follow-up ranged from 24 to 48 months (mean 31.2). Results: Technical success was achieved in all patients. Complete exclusion of the aneurysm with sac shrinking was achieved in two patients. Two stents became occluded at 6- and 24-month follow-up, respectively; both patients were asymptomatic and were not retreated. One patient developed sac reperfusion due to incomplete aneurysm exclusion. Conclusion: Long-term results in a wider population are needed to validate the effectiveness of the CMFM.

  10. Employment status five years after a randomised controlled trial comparing multidisciplinary and brief intervention in employees on sick leave due to low back pain.

    Science.gov (United States)

    Pedersen, Pernille; Nielsen, Claus Vinther; Jensen, Ole Kudsk; Jensen, Chris; Labriola, Merete

    2018-05-01

    To evaluate differences in employment status, during a five-year follow-up period in patients on sick leave due to low back pain who had participated in a trial comparing a brief and a multidisciplinary intervention. From 2004 to 2008, 535 patients were referred to the Spine Centre at the Regional Hospital in Silkeborg if they had been on sick leave for 3-16 weeks due to low back pain. All patients underwent a clinical examination by a rehabilitation physician and a physiotherapist, and were randomised to either the brief intervention or the multidisciplinary intervention. The outcome was employment status from randomisation to five years of follow-up and was measured by the mean number of weeks in four different groups of employment status (sequence analysis) and a fraction of the number of weeks working (work participation score) that were accumulated over the years. A total of 231 patients were randomised to the brief intervention and 233 patients to the multidisciplinary intervention. No statistically significant differences in the mean weeks spent within the different employment statuses were found between the two intervention groups. After five years of follow-up, participants in the multidisciplinary intervention had a 19% higher risk of not having a work participation score above 75% compared to participants in the brief intervention. After five years of follow-up no differences in employment status were found between participants in the brief and the multidisciplinary intervention.

  11. Five-year healing results of radiotherapy in 4347 uterine cervix cancers treated within the period of 1928 to 1977

    International Nuclear Information System (INIS)

    Tschakert, H.

    1986-01-01

    The author presents the five-year healing results of 4347 uterine cervix cancers treated at our Radiotherapeutic Institute within the years of 1928 to 1977. The part of patients irradiated postoperatively increased by 30% during this period, and the average age of patients at the beginning of their disease increased by almost seven years. The overall five-year healing results increased from 47 to 60% during this half of a century, especially the prognosis of stage II and III was considerably improved. With almost the same rate of radiogenic side effects, the incidence of recurrences could be reduced by 50%. The healing results achieved by us in uterine cervix cancer during the last ten years under report correspond well with the healing results of other radiotherapeutic hospitals. Even when compared to the most recent reports on the success achieved by afterloading techniques, there is not much difference to our recent results obtained with radium brachytherapy. (orig.) [de

  12. Behind the shine: An appraisal of five years of Danish CCTV trials

    DEFF Research Database (Denmark)

    Ulrich, Clara; Dalskov, Jørgen; Egekvist, Josefine

    2014-01-01

    Denmark has been the first nation in Europe to promote the use of Fully Documented Fisheries (FDF) through Remote Electronic Monitoring (REM) and CCTV camera systems, and some pilot schemes for monitoring cod catches have been in place since 2008. In theory, such a scheme could supplement and even...... potentially replace expensive control and monitoring programs; and, when associated to a Catch Quota management system, incentivize positive changes in fishing patterns in a results-based management approach. However, in practice, the technical and institutional challenges remain important hurdles to overcome...... for the system to be beneficial and reliable. In this paper we investigate the added value on catch information gained over the last five years, and discuss the future of REM as a monitoring program in the context of the future discards ban...

  13. Five-year follow-up of knee joint cartilage thickness changes after acute anterior cruciate ligament rupture

    DEFF Research Database (Denmark)

    Eckstein, F; Wirth, W; Lohmander, Stefan

    2015-01-01

    Objective: Anterior cruciate ligament (ACL) rupture involves increased risk of osteoarthritis. We explored cartilage thickness changes over five years after ACL rupture. Methods: 121 young active adults (26% women, age 18-35 years) with acute traumatic ACL rupture were studied (the KANON-trial). ...

  14. One-year outcomes of a randomized controlled trial of housing first with ACT in five Canadian cities.

    Science.gov (United States)

    Aubry, Tim; Tsemberis, Sam; Adair, Carol E; Veldhuizen, Scott; Streiner, David; Latimer, Eric; Sareen, Jitender; Patterson, Michelle; McGarvey, Kathleen; Kopp, Brianna; Hume, Catharine; Goering, Paula

    2015-05-01

    Housing First is a groundbreaking approach to ending chronic homelessness among people with mental illness. This article presents one-year findings from a multisite randomized controlled trial (RCT) comparing Housing First with treatment as usual. The study was a nonblind, parallel-group RCT conducted in five Canadian cities. A sample of 950 high-need participants with severe mental illness, who were either absolutely homeless or precariously housed, was randomly assigned to Housing First (N=469) or treatment as usual (N=481). Housing First participants received a rent supplement, assistance to find housing, and assertive community treatment. Treatment-as-usual participants had access to all other existing programs. At one-year follow-up, 73% of Housing First participants and 31% of treatment-as-usual participants resided in stable housing (plife was significantly greater among Housing First participants compared with treatment-as-usual participants (pHousing First participants also showed greater improvements in community functioning compared with treatment-as-usual participants (p=.003, d=.25, CI=.09-.41). Compared with treatment as usual, Housing First produced greater improvements in housing stability, quality of life, and community functioning after one year of enrollment. The study provides support for adopting Housing First as an approach for ending chronic homelessness among persons with severe mental illness, even if they are actively symptomatic or using substances.

  15. Interventions for increasing fruit and vegetable consumption in children aged five years and under.

    Science.gov (United States)

    Hodder, Rebecca K; Stacey, Fiona G; O'Brien, Kate M; Wyse, Rebecca J; Clinton-McHarg, Tara; Tzelepis, Flora; James, Erica L; Bartlem, Kate M; Nathan, Nicole K; Sutherland, Rachel; Robson, Emma; Yoong, Sze Lin; Wolfenden, Luke

    2018-01-25

    Insufficient consumption of fruits and vegetables in childhood increases the risk of future chronic diseases, including cardiovascular disease. To assess the effectiveness, cost effectiveness and associated adverse events of interventions designed to increase the consumption of fruit, vegetables or both amongst children aged five years and under. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE and Embase to identify eligible trials on 25 September 2017. We searched Proquest Dissertations and Theses and two clinical trial registers in November 2017. We reviewed reference lists of included trials and handsearched three international nutrition journals. We contacted authors of included studies to identify further potentially relevant trials. We included randomised controlled trials, including cluster-randomised controlled trials and cross-over trials, of any intervention primarily targeting consumption of fruit, vegetables or both among children aged five years and under, and incorporating a dietary or biochemical assessment of fruit or vegetable consumption. Two review authors independently screened titles and abstracts of identified papers; a third review author resolved disagreements. Two review authors independently extracted data and assessed the risks of bias of included studies; a third review author resolved disagreements. Due to unexplained heterogeneity, we used random-effects models in meta-analyses for the primary review outcomes where we identified sufficient trials. We calculated standardised mean differences (SMDs) to account for the heterogeneity of fruit and vegetable consumption measures. We conducted assessments of risks of bias and evaluated the quality of evidence (GRADE approach) using Cochrane procedures. We included 55 trials with 154 trial arms and 11,108 participants. Thirty-three trials examined the impact of child-feeding practices (e.g. repeated food exposure) in increasing child

  16. Results from the Xylitol for Adult Caries Trial (X-ACT)

    Science.gov (United States)

    Bader, James D.; Vollmer, William M.; Shugars, Daniel A.; Gilbert, Gregg H.; Amaechi, Bennett T.; Brown, John P.; Laws, Reesa L.; Funkhouser, Kimberly A.; Makhija, Sonia K.; Ritter, André V.; Leo, Michael C.

    2013-01-01

    Background Although caries is prevalent in adults, few preventive therapies have been tested in adult populations. This randomized clinical trial evaluated the effectiveness of xylitol lozenges in preventing caries in elevated caries-risk adults. Methods X-ACT was a three-site placebo-controlled randomized trial. Participants (n=691) ages 21–80 consumed five 1.0 g xylitol or placebo lozenges daily for 33 months. Clinical examinations occurred at baseline, 12, 24 and 33 months. Results Xylitol lozenges reduced the caries increment 11%. This reduction, which represented less than one-third of a surface per year, was not statistically significant. There was no indication of a dose-response effect. Conclusions Daily use of xylitol lozenges did not result in a statistically or clinically significant reduction in 33-month caries increment among elevated caries-risk adults. Clinical Implications These results suggest that xylitol used as a supplement in adults does not significantly reduce their caries experience. PMID:23283923

  17. Five years of an educational programme - Results and experiences

    International Nuclear Information System (INIS)

    Dufkova, Marie

    1998-01-01

    Full text: School teachers and pupils constitute an important group having the ability to listen, Understand and help to create positive ties between the public and a utility. Therefore, CEZ spends a part of its revenue arising from the sales of electricity on education. CEZ's information and education programme named 'Energy for everybody' has been used by Czech schools for five years now. The main part of this educational programme is devoted to nuclear energy. CEZ materials for schools include: printed information, supplements to textbooks, videotapes, computer programmes, CD ROMs, an educational set for experiments with ionizing radiation, posters and other assorted materials. Schools are invited to visit Czech power plants and other facilities of the power sector (for example the experimental reactor at the Prague Technical University). Seminars and workshops are organised for teachers. CEZ offers objective information on all activities associated with energy generation and uses and the relationships between man and nature. The prices of our informational materials are rather symbolic, they come to one-tenth to one-third of the actual cost. CEZ is the only industrial company offering such a large-scale educational programme for schools in the Czech Republic. Materials are distributed to nearly 7 000 primary and secondary schools and 30 university departments. We have agreements with several schools which have committed themselves to testing our materials. Several dissertations and studies have demonstrated the usefulness of our materials for education and the contribution this information has made to the better understanding of nuclear energy. We have organised polls in order to ascertain how the schools liked the materials, what additional things they wished and what their view of nuclear power plants and CEZ was. The outcome has been unexpectedly favourable. In my contribution I will present the results of these polls and examples of successful activities

  18. Hip-Hop to Health Jr. Randomized Effectiveness Trial: 1-Year Follow-up Results.

    Science.gov (United States)

    Kong, Angela; Buscemi, Joanna; Stolley, Melinda R; Schiffer, Linda A; Kim, Yoonsang; Braunschweig, Carol L; Gomez-Perez, Sandra L; Blumstein, Lara B; Van Horn, Linda; Dyer, Alan R; Fitzgibbon, Marian L

    2016-02-01

    The preschool years provide a unique window of opportunity to intervene on obesity-related lifestyle risk factors during the formative years of a child's life. The purpose of this study was to assess the impact of a preschool-based obesity prevention effectiveness trial at 1-year follow-up. RCT. Primarily African American children (aged 3-5 years, N=618) attending Head Start preschool programs administered by Chicago Public Schools. Eighteen preschools were randomly assigned in 2007-2008 to receive either (1) a 14-week teacher-delivered intervention focused on healthy lifestyle behaviors or (2) a 14-week teacher-delivered general health curriculum (control group). The primary outcome, BMI, was measured at baseline, postintervention, and 1-year follow-up. Diet and screen time behaviors were also assessed at these time points. Multilevel mixed effects models were used to test for between-group differences. Data were analyzed in 2014. Significant between-group differences were observed in diet, but not in BMI z-score or screen time at 1-year follow-up. Diet differences favored the intervention arm over controls in overall diet quality (p=0.02) and in subcomponents of diet quality, as measured by the Healthy Eating Index-2005, and in fruit intake (servings/day, excludes juice) (p=0.02). Diet quality worsened more among controls than the intervention group at 1-year follow-up. The adaptation of Hip-Hop to Health Jr. produced modest benefits in diet quality but did not significantly impact weight gain trajectory. Not unlike other effectiveness trials, this real-world version delivered by Head Start teachers produced fewer benefits than the more rigorous efficacy trial. It is important to understand and build upon the lessons learned from these types of trials so that we can design, implement, and disseminate successful evidence-based programs more widely and effectively. This study is registered at www.clinicaltrials.gov NCT00241878. Copyright © 2016 American Journal of

  19. Ten-year results of a randomized clinical trial comparing radical mastectomy and total mastectomy with or without radiation

    International Nuclear Information System (INIS)

    Fisher, B.; Redmond, C.; Fisher, E.R.

    1985-01-01

    In 1971 a randomized trial was begun to compare alternative local and regional treatments of breast cancer, all of which employ breast removal. Life-table estimates were obtained for 1665 women enrolled in the study for a mean of 126 months. There were no significant differences among three groups of patients with clinically negative auxillary nodes, with respect to disease-free survival, distant-disease-free survival, or overall survival (about 57%) at 10 years. The patients were treated by radical mastectomy, total (simple) mastectomy without auxillary dissection but with regional irradiation, or total mastectomy without irradiation plus auxillary dissection only if nodes were subsequently positive. Similarly, no differences, were observed between patients with clinically positive nodes treated by radical mastectomy or by total mastectomy without auxillary dissection but with regional irradiation. Survival at 10 years was about 38% in both groups. Our findings indicate that the location of a breast tumor does not influence the prognosis and that irradiation of internal mammary nodes in patients with inner-quadrant lesions does not improve survival. The data also demonstrate that the results obtained at five years accurately predict the outcome at 10 years. It was concluded that the variations of local and regional treatment used in this study are not important in determining survival of patients with breast cancer. 25 references, 6 figures, 1 table

  20. Twenty-seven years of phase III trials for patients with extensive disease small-cell lung cancer: disappointing results.

    Directory of Open Access Journals (Sweden)

    Isao Oze

    Full Text Available BACKGROUND: Few studies have formally assessed whether treatment outcomes have improved substantially over the years for patients with extensive disease small-cell lung cancer (ED-SCLC enrolled in phase III trials. The objective of the current investigation was to determine the time trends in outcomes for the patients in those trials. METHODS AND FINDINGS: We searched for trials that were reported between January 1981 and August 2008. Phase III randomized controlled trials were eligible if they compared first-line, systemic chemotherapy for ED-SCLC. Data were evaluated by using a linear regression analysis. RESULTS: In total, 52 trials were identified that had been initiated between 1980 and 2006; these studies involved 10,262 patients with 110 chemotherapy arms. The number of randomized patients and the proportion of patients with good performance status (PS increased over time. Cisplatin-based regimens, especially cisplatin and etoposide (PE regimen, have increasingly been studied, whereas cyclophosphamide, doxorubicin, and vincristine-based regimens have been less investigated. Multiple regression analysis showed no significant improvement in survival over the years. Additionally, the use of a PE regimen did not affect survival, whereas the proportion of patients with good PS and the trial design of assigning prophylactic cranial irradiation were significantly associated with favorable outcome. CONCLUSIONS AND SIGNIFICANCE: The survival of patients with ED-SCLC enrolled in phase III trials did not improve significantly over the years, suggesting the need for further development of novel targets, newer agents, and comprehensive patient care.

  1. Results of an Oncology Clinical Trial Nurse Role Delineation Study.

    Science.gov (United States)

    Purdom, Michelle A; Petersen, Sandra; Haas, Barbara K

    2017-09-01

    To evaluate the relevance of a five-dimensional model of clinical trial nursing practice in an oncology clinical trial nurse population. 
. Web-based cross-sectional survey.
. Online via Qualtrics.
. 167 oncology nurses throughout the United States, including 41 study coordinators, 35 direct care providers, and 91 dual-role nurses who provide direct patient care and trial coordination.
. Principal components analysis was used to determine the dimensions of oncology clinical trial nursing practice.
. Self-reported frequency of 59 activities.
. The results did not support the original five-dimensional model of nursing care but revealed a more multidimensional model.
. An analysis of frequency data revealed an eight-dimensional model of oncology research nursing, including care, manage study, expert, lead, prepare, data, advance science, and ethics.
. This evidence-based model expands understanding of the multidimensional roles of oncology nurses caring for patients with cancer enrolled in clinical trials.

  2. Type 2 diabetes prevention in the "real world": one-year results of the GOAL Implementation Trial.

    Science.gov (United States)

    Absetz, Pilvikki; Valve, Raisa; Oldenburg, Brian; Heinonen, Heikki; Nissinen, Aulikki; Fogelholm, Mikael; Ilvesmäki, Vesa; Talja, Martti; Uutela, Antti

    2007-10-01

    "Real-world" implementation of lifestyle interventions is a challenge. The Good Ageing in Lahti Region (GOAL) Lifestyle Implementation Trial was designed for the primary health care setting, with lifestyle and risk reduction objectives derived from the major diabetes prevention efficacy trials. We report on the program's effectiveness as well as findings related to the program's reach, adoption, and implementation. A total of 352 middle-aged participants with elevated type 2 diabetes risk were recruited from the health care centers in Päijät-Häme Province in Finland. The intervention included six group counseling sessions, delivered by trained public health nurses. Measurement was conducted at baseline and 12 months. Clinical risk factors were measured by study nurses, and lifestyle outcomes were analyzed from self-reports. Lifestyle outcomes were compared with the outcomes achieved in relevant efficacy trials, and within-subject changes were tested for risk reduction. At baseline, mean BMI was >32 kg/m2, and 25% of the participants had impaired glucose tolerance. At 12 months, 20% of participants achieved at least four of five key lifestyle outcomes, with these results being comparable with the reference trials. However, physical activity and weight loss goals were achieved significantly less frequently (65 vs. 86% and 12 vs. 43%, respectively). Several clinical risk factors decreased, more so among men than women. This trial demonstrates that lifestyle counseling can be effective and is feasible in real-world settings for individuals with elevated risk of type 2 diabetes. To increase program impact, program exposure and treatment intensity need to be increased.

  3. North American trial results at 1 year with the Sorin Freedom SOLO pericardial aortic valve.

    Science.gov (United States)

    Heimansohn, David; Roselli, Eric E; Thourani, Vinod H; Wang, Shaohua; Voisine, Pierre; Ye, Jian; Dabir, Reza; Moon, Michael

    2016-02-01

    A North American prospective, 15-centre Food and Drug Administration (FDA) valve trial was designed to assess the safety and effectiveness of the Freedom SOLO stentless pericardial aortic valve in the treatment of surgical aortic valve disease. Beginning in 2010, 251 patients (mean: 74.7 ± 7.5 years), were recruited in the Freedom SOLO aortic valve trial. One hundred eighty-nine patients have been followed for at least 1 year and are the basis for this review. Preoperatively, 54% of patients had NYHA functional class III or IV symptoms, and the majority of patients had a normal ejection fraction (EF) (median EF = 61%). Concomitant procedures were performed in 61.9% of patients, with coronary artery bypass grafting (CABG) (48.7%) being the most common followed by a MAZE procedure (13.7%). Reoperations were performed in 8.5% of patients in the study. The entire cohort of 251 patients enrolled had 7 deaths prior to 30 days, 2 of which were valve-related (aspiration pneumonia and sudden death) and 5 were not valve-related. There were 11 deaths after 30 days, 1 valve-related (unknown cardiac death) and 10 not valve-related. Five valves were explanted, 3 early (endocarditis, acute insufficiency and possible root dissection) and 2 late (endocarditis). Thirty-day adverse events include arrhythmias requiring permanent pacemaker (4.2%), thromboembolic events (3.7%) and thrombocytopenia (7.4%). One-year follow-up of all 189 patients demonstrated mean gradients for valve sizes 19, 21, 23, 25 and 27 mm of 11.7, 7.8, 6.3, 4.6 and 5.0 mmHg, respectively. Effective orifice areas for the same valve sizes were 1.2, 1.3, 1.6, 1.8 and 1.9 cm(2), respectively. Ninety-six percent of patients (181/189) were in NYHA class I or II at the 1-year follow-up. The Freedom SOLO stentless pericardial aortic valve demonstrated excellent haemodynamics and a good safety profile out to the 1 year of follow-up. © The Author 2015. Published by Oxford University Press on behalf of the European

  4. Rotator Cuff Calcific Tendinitis: Ultrasound-Guided Needling and Lavage Versus Subacromial Corticosteroids: Five-Year Outcomes of a Randomized Controlled Trial.

    Science.gov (United States)

    de Witte, Pieter Bas; Kolk, Arjen; Overes, Ferdinand; Nelissen, Rob G H H; Reijnierse, Monique

    2017-12-01

    Barbotage (needling and lavage) is often applied in the treatment of calcific tendinitis of the rotator cuff (RCCT). In a previously published randomized controlled trial, we reported superior clinical and radiological 1-year outcomes for barbotage combined with a corticosteroid injection in the subacromial bursa (SAIC) compared with an isolated SAIC. There are no trials with a midterm or long-term follow-up of barbotage available. To compare the 5-year results of 2 regularly applied treatments of RCCT: ultrasound (US)-guided barbotage combined with a SAIC (group 1) versus an isolated US-guided SAIC (group 2). Randomized controlled trial; Level of evidence, 1. Patients were randomly assigned to group 1 or 2 and evaluated before and after treatment at regular time points until 12 months and also at 5 years using the Constant score (CS), the Western Ontario Rotator Cuff Index (WORC), and the Disabilities of the Arm, Shoulder and Hand (DASH). The calcification location and size and Gärtner classification were assessed on radiographs. The rotator cuff condition was evaluated with US. Results were analyzed using t tests, linear regression, and a mixed model for repeated measures. Forty-eight patients were included (mean age, 52.0 ± 7.3 years; 25 [52%] female) with a mean baseline CS of 68.7 ± 11.9. After a mean follow-up of 5.1 ± 0.5 years, the mean CS was 90 (95% CI, 83.0-95.9) in group 1 versus 87 (95% CI, 80.5-93.5) in group 2 ( P = .58). The mean improvement in the CS in group 1 was 18 (95% CI, 12.3-23.0) versus 21 (95% CI, 16.2-26.2) in group 2 ( P = .32). There was total resorption in 62% of group 1 and 73% of group 2 ( P = .45). The US evaluation of the rotator cuff condition showed no significant differences between the groups. With the mixed model for repeated measures, taking into account the baseline CS and Gärtner classification, the mean treatment effect for barbotage was 6 (95% CI, -8.9 to 21.5), but without statistical significance. Follow-up scores

  5. The Hi Five study: design of a school-based randomized trial to reduce infections and improve hygiene and well-being among 6-15 year olds in Denmark.

    Science.gov (United States)

    Johansen, Anette; Denbæk, Anne Maj; Bonnesen, Camilla Thørring; Due, Pernille

    2015-03-01

    Infectious illnesses such as influenza and diarrhea are leading causes of absenteeism among Danish school children. Interventions in school settings addressing hand hygiene have shown to reduce the number of infectious illnesses. However, most of these studies include small populations and almost none of them are conducted as randomized controlled trials. The overall aim of the Hi Five study was to develop, implement and evaluate a multi-component school-based intervention to improve hand hygiene and well-being and to reduce the prevalence of infections among school children in intervention schools by 20% compared to control schools. This paper describes the development and the evaluation design of Hi Five. The Hi Five study was designed as a tree-armed cluster-randomized controlled trial. A national random sample of schools (n = 44) was randomized to one of two intervention groups (n = 29) or to a control group with no intervention (n = 15). A total of 8,438 six to fifteen-year-old school children were enrolled in the study. The Hi Five intervention consisted of three components: 1) a curriculum component 2) mandatory daily hand washing before lunch 3) extra cleaning of school toilets during the school day. Baseline data was collected from December 2011 to April 2012. The intervention period was August 2012 to June 2013. The follow-up data was collected from December 2012 to April 2013. The Hi Five study fills a gap in international research. This large randomized multi-component school-based hand hygiene intervention is the first to include education on healthy and appropriate toilet behavior as part of the curriculum. No previous studies have involved supplementary cleaning at the school toilets as an intervention component. The study will have the added value of providing new knowledge about usability of short message service (SMS, text message) for collecting data on infectious illness and absenteeism in large study populations. Current Controlled

  6. Voluntary research results for five years along the master plan on nuclear safety research. FY 2001 - 2005

    International Nuclear Information System (INIS)

    Sato, Yoshinori

    2006-05-01

    Safety Research has been conducted from FY 2001 to FY 2005 according to the Master Plan on Nuclear Safety Research (FY 2001-2005) in Japan Atomic Energy Agency which took over former Japan Nuclear Cycle Development Institute. This report shows the voluntary research results for five years conducted from FY 2001 to FY 2005 according to the Master Plan on Nuclear Safety Research (FY 2001-2005). (author)

  7. Interventions for increasing fruit and vegetable consumption in children aged five years and under.

    Science.gov (United States)

    Hodder, Rebecca K; O'Brien, Kate M; Stacey, Fiona G; Wyse, Rebecca J; Clinton-McHarg, Tara; Tzelepis, Flora; James, Erica L; Bartlem, Kate M; Nathan, Nicole K; Sutherland, Rachel; Robson, Emma; Yoong, Sze Lin; Wolfenden, Luke

    2018-05-17

    Insufficient consumption of fruits and vegetables in childhood increases the risk of future non-communicable diseases, including cardiovascular disease. Interventions to increase consumption of fruit and vegetables, such as those focused on specific child-feeding strategies and parent nutrition education interventions in early childhood may therefore be an effective strategy in reducing this disease burden. To assess the effectiveness, cost effectiveness and associated adverse events of interventions designed to increase the consumption of fruit, vegetables or both amongst children aged five years and under. We searched CENTRAL, MEDLINE, Embase and two clinical trials registries to identify eligible trials on 25 January 2018. We searched Proquest Dissertations and Theses in November 2017. We reviewed reference lists of included trials and handsearched three international nutrition journals. We contacted authors of included studies to identify further potentially relevant trials. We included randomised controlled trials, including cluster-randomised controlled trials and cross-over trials, of any intervention primarily targeting consumption of fruit, vegetables or both among children aged five years and under, and incorporating a dietary or biochemical assessment of fruit or vegetable consumption. Two review authors independently screened titles and abstracts of identified papers; a third review author resolved disagreements. Two review authors independently extracted data and assessed the risks of bias of included studies; a third review author resolved disagreements. Due to unexplained heterogeneity, we used random-effects models in meta-analyses for the primary review outcomes where we identified sufficient trials. We calculated standardised mean differences (SMDs) to account for the heterogeneity of fruit and vegetable consumption measures. We conducted assessments of risks of bias and evaluated the quality of evidence (GRADE approach) using Cochrane procedures

  8. 40 CFR 68.42 - Five-year accident history.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 15 2010-07-01 2010-07-01 false Five-year accident history. 68.42... (CONTINUED) CHEMICAL ACCIDENT PREVENTION PROVISIONS Hazard Assessment § 68.42 Five-year accident history. (a) The owner or operator shall include in the five-year accident history all accidental releases from...

  9. Twenty-Five Years of Gene Therapy for ADA-SCID: From Bubble Babies to an Approved Drug.

    Science.gov (United States)

    Ferrua, Francesca; Aiuti, Alessandro

    2017-11-01

    Twenty-five years have passed since first attempts of gene therapy (GT) in children affected by severe combined immunodeficiency (SCID) due to adenosine deaminase (ADA) defect, also known by the general public as bubble babies. ADA-SCID is fatal early in life if untreated. Unconditioned hematopoietic stem cell (HSC) transplant from matched sibling donor represents a curative treatment but is available for few patients. Enzyme replacement therapy can be life-saving, but its chronic use has many drawbacks. This review summarizes the history of ADA-SCID GT over the last 25 years, starting from first pioneering studies in the early 1990s using gamma-retroviral vectors, based on multiple infusions of genetically corrected autologous peripheral blood lymphocytes. HSC represented the ideal target for gene correction to guarantee production of engineered multi-lineage progeny, but it required a decade to achieve therapeutic benefit with this approach. Introduction of low-intensity conditioning represented a crucial step in achieving stable gene-corrected HSC engraftment and therapeutic levels of ADA-expressing cells. Recent clinical trials demonstrated that gamma-retroviral GT for ADA-SCID has a favorable safety profile and is effective in restoring normal purine metabolism and immune functions in patients >13 years after treatment. No abnormal clonal proliferation or leukemia development have been observed in >40 patients treated experimentally in five different centers worldwide. In 2016, the medicinal product Strimvelis™ received marketing approval in Europe for patients affected by ADA-SCID without a suitable human leukocyte antigen-matched related donor. Positive safety and efficacy results have been obtained in GT clinical trials using lentiviral vectors encoding ADA. The results obtained in last 25 years in ADA-SCID GT development fundamentally contributed to improve patients' prognosis, together with earlier diagnosis thanks to newborn screening. These advances

  10. The 2010 five-yearly review has started

    CERN Multimedia

    Association du personnel

    2009-01-01

    Every five years, the financial and social conditions of members of the personnel are examined according to the procedures defined in Annex A1 of the Staff Rules and Regulations (SR&R). This exercise is called the “five-yearly review” (5YR).

  11. The Five-Year Resume: A Career Planning Exercise

    Science.gov (United States)

    Laker, Dennis R.; Laker, Ruth

    2007-01-01

    For most college students, lack of career planning wastes time and resources and may result in years of "career drift." Lack of planning can also lead to deception once students begin seeking career-related employment. Faced with a competitive job market, some students inflate and exaggerate their resumes. The five-year resume exercise helps…

  12. Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial).

    Science.gov (United States)

    Généreux, Philippe; Lee, Arthur C; Kim, Christopher Y; Lee, Michael; Shlofmitz, Richard; Moses, Jeffrey W; Stone, Gregg W; Chambers, Jeff W

    2015-06-15

    Percutaneous coronary intervention of severely calcified lesions has historically been associated with major adverse cardiac event (MACE) rates as high as 30%. In the ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial, treatment of de novo severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) resulted in low rates of procedural and 30-day adverse ischemic events. The long-term results from this trial have not been reported. We sought to determine the 1-year outcomes after orbital atherectomy of severely calcified coronary lesions. ORBIT II was a single-arm trial enrolling 443 subjects at 49 US sites with severely calcified lesions usually excluded from randomized trials. OAS utilizes a centrifugal differential sanding mechanism of action for plaque modification prior to stent implantation. After OAS drug-eluting stents were implanted in 88.2% of the patients. The primary safety end point was 30-day MACE, the composite of cardiac death, myocardial infarction, or target vessel revascularization [TVR]. The present analysis reports the 1-year follow-up results from ORBIT II. One-year data were available in 433 of 443 patients (97.7%), with median follow-up time of 16.7 months. The 1-year MACE rate was 16.4%, including cardiac death (3.0%), myocardial infarction (9.7%), and target vessel revascularization (5.9%). The 1-year target lesion revascularization rate was 4.7%, and stent thrombosis occurred in 1 patient (0.2%). Independent predictors of 1-year MACE and target vessel revascularization were diameter stenosis at baseline and the use of bare-metal stents. In patients with severely calcified lesions who underwent percutaneous coronary intervention, the use of OAS was associated with low rates of 1-year adverse ischemic events compared with historical controls. This finding has important clinical implications for the selection of optimum treatment strategies for patients

  13. IPS Empress crown system: three-year clinical trial results.

    Science.gov (United States)

    Sorensen, J A; Choi, C; Fanuscu, M I; Mito, W T

    1998-02-01

    The IPS Empress system is a highly esthetic hot pressed glass ceramic material for fabrication of single crowns. Adhesive cementation of the system not only contributes to the esthetics but is necessary for increased strength of the crown. The purpose of this prospective clinical trials was to evaluate the longevity of 75 adhesively cemented Empress full crowns. An additional aim was to assess the adhesive cementation methodology and potential side effects. At the three-year point, one molar crown fractured for a 1.3 percent failure rate. The resin cementation technique that was employed exhibited a low incidence of microleakage with few clinical side effects. There was a 5.6 percent incidence of post-cementation sensitivity, with all symptoms subsiding by eight weeks. None of the crowns in the study required endodontic therapy.

  14. Five-year clinical and functional multislice computed tomography angiographic results after coronary implantation of the fully resorbable polymeric everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB cohort A trial.

    Science.gov (United States)

    Onuma, Yoshinobu; Dudek, Dariusz; Thuesen, Leif; Webster, Mark; Nieman, Koen; Garcia-Garcia, Hector M; Ormiston, John A; Serruys, Patrick W

    2013-10-01

    This study sought to demonstrate the 5-year clinical and functional multislice computed tomography angiographic results after implantation of the fully resorbable everolimus-eluting scaffold (Absorb BVS, Abbott Vascular, Santa Clara, California). Multimodality imaging of the first-in-humans trial using a ABSORB BVS scaffold demonstrated at 2 years the bioresorption of the device while preventing restenosis. However, the long-term safety and efficacy of this therapy remain to be documented. In the ABSORB cohort A trial (ABSORB Clinical Investigation, Cohort A [ABSORB A] Everolimus-Eluting Coronary Stent System Clinical Investigation), 30 patients with a single de novo coronary artery lesion were treated with the fully resorbable everolimus-eluting Absorb scaffold at 4 centers. As an optional investigation in 3 of the 4 centers, the patients underwent multislice computed tomography (MSCT) angiography at 18 months and 5 years. Acquired MSCT data were analyzed at an independent core laboratory (Cardialysis, Rotterdam, the Netherlands) for quantitative analysis of lumen dimensions and was further processed for calculation of fractional flow reserve (FFR) at another independent core laboratory (Heart Flow, Redwood City, California). Five-year clinical follow-up is available for 29 patients. One patient withdrew consent after 6 months, but the vital status of this patient remains available. At 46 days, 1 patient experienced a single episode of chest pain and underwent a target lesion revascularization with a slight troponin increase after the procedure. At 5 years, the ischemia-driven major adverse cardiac event rate of 3.4% remained unchanged. Clopidogrel was discontinued in all but 1 patient. Scaffold thrombosis was not observed in any patient. Two noncardiac deaths were reported, 1 caused by duodenal perforation and the other from Hodgkin's disease. At 5 years, 18 patients underwent MSCT angiography. All scaffolds were patent, with a median minimal lumen area of 3

  15. Environmental restoration and waste management five year plan, fiscal years 1994--1998

    International Nuclear Information System (INIS)

    1993-01-01

    In March 1989, Secretary of Energy James D. Watkins outlined his vision for a changed Department of Energy (DOE) culture. This culture is one of envirorunental responsibility, increased knowledge and involvement in environmental management, a new openness to public input, and overall accountability to the Nation for its actions. Secretary Watkins also requested all the near-term activities necessary to bring DOEactivities into compliance with all applicable environmental requirements to be detailed in one plan. The Five-Year Plan was to be based on a ''bottom up'' approach to planning by using Activity Data Sheets to collect financial and technical information at the installation level. Over the past three years, the Five-Year Plan has evolved into the primary planning tool for the DOE Environmental Restoration and Waste Management Program, looking beyond the current three-year Federal budget horizon. The FY 1994--1998 Five-Year Plan demonstrates DOE's commitment to a culture based on the principles of openness, responsiveness, and accountability; reports on the progress made in carrying out DOE's environmental mission; identifies what must be accomplished during a five-year planning period; and describes strategies for achieving critical program objectives. This plan represents another step towards the implementation of the culture change Secretary Watkins envisioned. The Five-Year Plan is not exclusively focused on near-term activities. Italso expresses the DOE commitment to a 30-year goal for the cleanup of the 1989 inventory of inactive sites. The FY 1994--1998 Five-Year Plan reiterates the DOE commitment to meeting this and other important environmental goals

  16. The 2015 five-yearly review

    CERN Multimedia

    Staff Association

    2014-01-01

      This year CERN celebrates its 60th anniversary. On this occasion, throughout Europe — most recently on July 1st at the UNESCO headquarters in Paris — festivities are being organized to celebrate the Organization’s success as a flagship laboratory of high-energy physics. To ensure that CERN can remain a centre of excellence in the field of fundamental research, the Organization verifies every five years with the help of a five-yearly review procedure whether the financial and social conditions which it proposes to Staff Members allow it to recruit and retain Staff Members of the highest competence and integrity required for the execution of its mission from all its Member States. For Fellows these conditions should remain attractive compared with those in comparable research institutions, while for Associated members of personnel these conditions should allow it to host them in its research facilities taking into account the highest cost-of-living level in the local ...

  17. Environmental restoration and waste management five-year plan, Fiscal years 1994--1998

    International Nuclear Information System (INIS)

    1993-01-01

    In March 1989, Secretary of Energy James D. Watkins outlined his vision for a changed Department of Energy (DOE) culture. This culture is one of environmental responsibility, increased knowledge and involvement in environmental management, a new openness to public input, and overall accountability to the Nation for its actions. Over the past three years, the Five Year Plan has evolved into the primary planning tool for the DOE Environmental Restoration and Waste Management Program, looking beyond the current three-year Federal budget horizon. The FY 1994--1998 Five-Year Plan demonstrates DOE's commitment to a culture based on the principles of openness, responsiveness, and accountability; reports on the progress made in carrying out DOE's environmental mission; identifies what must be accomplished during a five-year planning period; and describes strategies for achieving critical program objectives. The Five-Year Plan is not exclusively focused on near-term activities. It also expresses the DOE commitment to a 30-year goal for the cleanup of the 1989 inventory of inactive sites. This goal was established in response to recommendations from the State and Tribal Government Working Group (STGWG) that DOE define a specific end point for completing necessary remediation and restoration activities. The FY 1994--1998 Five-Year Plan reiterates the DOE commitment to meeting this and other important environmental goals

  18. Five-year-old historian.

    Science.gov (United States)

    Morrison, Wynne

    2017-12-01

    In this poem, the author describes a doctor talking with a five-year-old child who has been brought to the hospital after being in a car accident with his/her mother and brother. The child is not able to remember the mother's name, but the doctor continues to talk with the child. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  19. Five-Year Outcomes of the First Pivotal Clinical Trial of Balloon-Expandable Transcatheter Aortic Valve Replacement in Japan (PREVAIL JAPAN).

    Science.gov (United States)

    Sawa, Yoshiki; Takayama, Morimasa; Goto, Tsuyoshi; Takanashi, Shuichiro; Komiya, Tatsuhiko; Tobaru, Tetsuya; Maeda, Koichi; Kuratani, Toru; Sakata, Yasushi

    2017-07-25

    Transcatheter aortic valve replacement (TAVR) has been an alternative less invasive therapy for high-surgical risk/inoperable patients with aortic valve stenosis (AS) in Japan. We report 5-year outcomes of the first pivotal clinical trial of TAVR in Japan (PREVAIL JAPAN).Methods and Results:A total of 64 patients with AS who were considered unsuitable candidates for surgery were enrolled at 3 centers in Japan (mean age: 84.3±6.1 years, female: 65.6%, STS score: 9.0±4.5%). Transfemoral approach (TF) and transapical approach (TA) was performed in 37 patients and 27 patients, respectively. At 5 years, freedom from all-cause death was 52.7% (TF: 51.3%, TA: 56.3%). Risk of all stroke at 5-year was 15.8% (TF: 8.9%, TA: 25.5%) and risk of major adverse cardiac and cerebrovascular events at 5 years was 58.0% (TF: 51.3%, TA: 69.2%). Mild or greater aortic regurgitation (AR) at 1 week was not associated with increased all-cause death at 5 years (69.1%) compared with none or trace AR (48.3%) (P=0.184). Patients with high STS score (>8) had higher mortality rate than those with low STS scores (≤8). The 5-year data from PREVAIL JAPAN show the clinical benefit of TAVR and suggest that balloon-expandable TAVR is an effective treatment option for Japanese patients with severe AS who are not suitable for surgery. (Funded by Edwards Lifesciences Limited; ClinicalTrials.gov number, NCT01113983.).

  20. Organizational results : annual report, fiscal year 2010.

    Science.gov (United States)

    2010-01-01

    What can you do in five years? Pay off a car? Send your kid to college? How about change an : organizations culture? Over the past five years thats what Organizational Results has attempted to do. : By placing business process experts and resea...

  1. Sustainable development: five structural milestones for the next five-year term

    International Nuclear Information System (INIS)

    Demailly, Damien; Treyer, Sebastien; Levai, David; Laurans, Yann; Rochette, Julien

    2017-05-01

    The energy transition, climate change, biodiversity, agriculture... the French President, the government and the new majority appointed by the 2017 elections will need to make some important decisions about sustainable development over the next five-year term. Their agenda will be marked in particular by five key events, not only in France, but also at the European and international levels. These five events will be opportunities to adapt the French economy to the major challenges of the 21. century, those of a regulated globalization, combining prosperity, social protection and environmental protection

  2. Willow Short Rotation Coppice Trial in a Former Mining Area in Northern Spain: Effects of Clone, Fertilization and Planting Density on Yield after Five Years

    Directory of Open Access Journals (Sweden)

    María Castaño-Díaz

    2018-03-01

    Full Text Available A willow short rotation coppice (SRC trial was conducted on former mining land in northern Spain over a period of five years, with the purpose of evaluating the effects on yield of two planting densities (9876 and 14,815 cuttings ha−1, three treatments (control, two levels of nitrogen, phosphorus and potassium compound fertilizer (NPK plus weed control and three willow clones (Björn, Inger, Olof. The area was subsoiled, ploughed, harrowed and fertilized with NPK before trial establishment. A randomized block design was applied, with three replications of each treatment in a total of 54 plots, each of an area of 400 m2. The effects of the interactions between the various factors on yield and other growth parameters were also studied. The clone factor significantly affected the number of shoots per stool (greatest for the Inger clone and the Olof clone, which showed the lowest mortality rate and produced the largest trees and largest quantity of biomass. The combined application of fertilizer and herbicide also significantly increased the values of all response variables considered, except the mortality rate. The planting density did not significantly affect the response variables. Clone × treatment interactions were significant for the shoots per stool, height, diameter and biomass variables, and the Olof clone displayed the highest height and diameter growth and yield. The results obtained in the first rotation indicate that the Olof clone adapted well to the trial conditions and therefore would be appropriate for producing biomass in abandoned mine land in Asturias. These findings will help in the development of strategies for the establishment and management of SRC on marginal land.

  3. Psychological stress and health in undergraduate dental students: fifth year outcomes compared with first year baseline results from five European dental schools

    NARCIS (Netherlands)

    Gorter, R.C.; Freeman, R.; Hammen, S.; Murtomaa, H.; Blinkhorn, A.; Humphris, G.

    2008-01-01

    Objective: To compare the levels of a series of health-related indicators from a cohort of fifth year dental students from five European schools with their first year scores, and to investigate the relationship between these follow-up measures. Methods: Burnout was measured using the Maslach Burnout

  4. Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial.

    Science.gov (United States)

    Lee, Michael; Généreux, Philippe; Shlofmitz, Richard; Phillipson, Daniel; Anose, Bynthia M; Martinsen, Brad J; Himmelstein, Stevan I; Chambers, Jeff W

    2017-06-01

    The presence of heavy coronary artery calcification increases the complexity of percutaneous coronary intervention (PCI) and increases the incidence of major adverse cardiac events (MACE): death, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis. The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial reported low rates of procedural, 30-day, 1-year, and 2-year ischemic complications after treatment of de novo, severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc.). ORBIT II was a single-arm trial that enrolled 443 patients at 49U.S. sites; in this study, de novo, severely calcified coronary lesions were treated with OAS prior to stenting. The primary safety endpoint was 30-day MACE: the composite of cardiac death, MI, and TVR (inclusive of target lesion revascularization (TLR)). The primary efficacy endpoint was procedural success: stent delivery with a residual stenosis of atherectomy. There were 360 (81.3%) subjects who completed the protocol-mandated 3-year visit.The overall cumulative rate of 3-year MACE was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%). The 3-year target lesion revascularization rate was 7.8%. In the final 3-year analysis of the ORBIT II trial, orbital atherectomy of severely calcified coronary lesions followed by stenting resulted in a low rate of adverse ischemic events compared with historical controls.Orbital atherectomy represents a safe and effective revascularization strategy for patients with severely calcified coronary lesions. The ORBIT II trial enrolled 443 subjects to study orbital atherectomy followed by stenting for de novo severely calcified coronary lesions. The overall cumulative 3-year MACE rate was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%); the 3-year target lesion revascularization rate was 7.8%. Orbital atherectomy

  5. Five-year workplace wellness intervention in the NHS.

    Science.gov (United States)

    Blake, Holly; Zhou, Dingyuan; Batt, Mark E

    2013-09-01

    Poor health and well-being has been observed among NHS staff and has become a key focus in current public health policy. The objective of this study was to deliver and evaluate a five-year employee wellness programme aimed at improving the health and well-being of employees in a large NHS workplace. A theory-driven multi-level ecological workplace wellness intervention was delivered including health campaigns, provision of facilities and health-promotion activities to encourage employees to make healthy lifestyle choices and sustained behaviour changes. An employee questionnaire survey was distributed at baseline (n = 1,452) and at five years (n = 1,134), including measures of physical activity, BMI, diet, self-efficacy, social support, perceived general health and mood, smoking behaviours, self-reported sickness absence, perceived work performance and job satisfaction. Samples were comparable at baseline and follow-up. At five years, significantly more respondents actively travelled (by walking or cycling both to work and for non-work trips) and more were active while at work. Significantly more respondents met current recommendations for physical activity at five years than at baseline. Fewer employers reported 'lack of time' as a barrier to being physically active following the intervention. Significantly lower sickness absence, greater job satisfaction and greater organisational commitment was reported at five years than at baseline. Improvements in health behaviours, reductions in sickness absence and improvements in job satisfaction and organisational commitment were observed following five years of a workplace wellness intervention for NHS employees. These findings suggest that health-promoting programmes should be embedded within NHS infrastructure.

  6. 40 CFR 68.168 - Five-year accident history.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 15 2010-07-01 2010-07-01 false Five-year accident history. 68.168 Section 68.168 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CHEMICAL ACCIDENT PREVENTION PROVISIONS Risk Management Plan § 68.168 Five-year accident history...

  7. Adjuvant therapy in stage I and stage II epithelial ovarian cancer. Results of two prospective randomized trials

    International Nuclear Information System (INIS)

    Young, R.C.; Walton, L.A.; Ellenberg, S.S.; Homesley, H.D.; Wilbanks, G.D.; Decker, D.G.; Miller, A.; Park, R.; Major, F. Jr.

    1990-01-01

    About a third of patients with ovarian cancer present with localized disease; despite surgical resection, up to half the tumors recur. Since it has not been established whether adjuvant treatment can benefit such patients, we conducted two prospective, randomized national cooperative trials of adjuvant therapy in patients with localized ovarian carcinoma. All patients underwent surgical resection plus comprehensive staging and, 18 months later, surgical re-exploration. In the first trial, 81 patients with well-differentiated or moderately well differentiated cancers confined to the ovaries (Stages Iai and Ibi) were assigned to receive either no chemotherapy or melphalan (0.2 mg per kilogram of body weight per day for five days, repeated every four to six weeks for up to 12 cycles). After a median follow-up of more than six years, there were no significant differences between the patients given no chemotherapy and those treated with melphalan with respect to either five-year disease-free survival or overall survival. In the second trial, 141 patients with poorly differentiated Stage I tumors or with cancer outside the ovaries but limited to the pelvis (Stage II) were randomly assigned to treatment with either melphalan (in the same regimen as above) or a single intraperitoneal dose of 32P (15 mCi) at the time of surgery. In this trial (median follow-up, greater than 6 years) the outcomes for the two treatment groups were similar with respect to five-year disease-free survival (80 percent in both groups) and overall survival (81 percent with melphalan vs. 78 percent with 32P; P = 0.48). We conclude that in patients with localized ovarian cancer, comprehensive staging at the time of surgical resection can serve to identify those patients (as defined by the first trial) who can be followed without adjuvant chemotherapy

  8. Suicide rates in five-year age-bands after the age of 60 years

    DEFF Research Database (Denmark)

    Shah, Ajit; Bhat, Ravi; Zarate-Escudero, Sofia

    2016-01-01

    -79 years) and the oldest old (80+ years) age groups. METHODS: Data on the number of suicides (International Classification of Diseases - ICD-10 codes, X60-84) in each of the eight five-year age-bands between the age-bands 60-64 years and 95-99 years in both gender for as many years as possible from 2000...... were ascertained from three sources: colleagues with access to national data, national statisics office websites and email contact with the national statistics offices. The population size for the corresponding years and age-bands was estimated for each country using data provided by the United Nations......BACKGROUND: There is paucity of studies examining suicide rates in narrow five-year age-bands after the age of 60 years. This study examined suicide rates in eight five-year age-bands between the age of 60 and 99 years because this will allow more precise comparison between the young old (60...

  9. TRIUMF: Five-year plan

    International Nuclear Information System (INIS)

    Anon.

    1995-01-01

    The Canadian government recently announced approval of a five-year-plan for TRIUMF, giving the Vancouver Laboratory assured funding until the year 2000. Besides continuation of the multidisciplinary cyclotron, this will allow construction of ISAC-1, a new on-line isotope separator. At the same time, TRIUMF will also be responsible for Canadian ''in-kind'' contributions to international science at CERN's LHC proton-proton collider (see page 1). The federal plan strengthens TRIUMF's role as a national facility, run by a consortium of universities across Canada. In addition, TRIUMF will have even stronger international links. The federal government has allocated a total of $166.6 million to TRIUMF over the next five years. In addition, the provincial British Columbia government, a long-time supporter of TRIUMF, has already agreed to provide approximately $10 million for conventional construction. The nature of the accelerator contributions to the LHC has not been finally decided, although two areas are under discussion - the upgrade of the accelerator chain, and construction of the two 'beam cleaning' insertions. The former would involve provision of various new systems (radiofrequency, magnets, power supplies, kickers, etc) for the Booster, PS and SPS synchrotrons; indeed activity is already underway in some areas, such as model studies for a new 40 MHz system for the PS. The acronym of the new facility, ISAC-1, is short for Isotope Separator & Accelerator. A prototype first stage already exists in TRIUMF. ISAC-1 will use the intense proton beam from the TRIUMF cyclotron to create powerful beams of exotic, short-lived, radioactive nuclei which will be accelerated in a new structure

  10. Five-year outcomes following a randomized trial of femorofemoral and femoropopliteal bypass grafting with heparin-bonded or standard polytetrafluoroethylene grafts

    DEFF Research Database (Denmark)

    Lindholt, Jes S.; Houlind, K.; Gottschalksen, B

    2016-01-01

    BACKGROUND: Cohort studies suggest superior long-term patency of luminal heparin-bonded polytetrafluoroethylene (Hb-PTFE) bypass grafts compared with standard PTFE grafts. The aim of this study was to compare the outcomes of Hb-PTFE grafts with those of standard PTFE grafts 5 years after...... a randomized trial. METHODS: Patients with intermittent claudication or critical limb ischaemia requiring femorofemoral or femoropopliteal bypass grafting were randomized in a clinical trial of Hb-PTFE versus standard PTFE in 11 Scandinavian centres between 2005 and 2009. Patients were followed up for 5 years...... of the primary outcome. Use of Hb-PTFE significantly improved patency by 37 per cent at 2 years, but 5 years after randomization there was no difference in primary patency (adjusted hazard ratio (HR) 0·95, 95 per cent c.i. 0·71 to 1·28; P = 0·748). In patients with critical limb ischaemia the use of Hb-PTFE...

  11. Columbine High: Five Years Later

    Science.gov (United States)

    Hurst, Marianne D.

    2004-01-01

    A few weeks before the fifth anniversary of the Columbine High School shootings on April 20, 1999, Principal Frank DeAngelis reflects on how his school has changed over the past five years. Much like the September 11, 2001 terrorist attacks against the United States, "Columbine" carries a chilling meaning that resonates across the…

  12. Food advertisements in two popular U.S. parenting magazines: results of a five-year analysis.

    Science.gov (United States)

    Basch, Corey Hannah; Hammond, Rodney; Ethan, Danna; Samuel, Lalitha

    2013-12-24

    Obesity rates among American youth have prompted an examination of food advertisements geared towards children. Research indicates children's high exposure to these advertisements and their influence on food preferences. Less is known about the presence of these advertisements in parenting magazines. This study's objective was to examine prevalence of food advertisements in popular parenting magazines and identify products by USDA food category. We analyzed 116 issues of two popular U.S. parenting magazines across five years. All food and beverage advertisements for USDA Food Category were coded. Breakfast cereals were coded for nutritional quality. The coding took place at varied libraries in New Jersey, in the United States. A total of 19,879 food and beverage products were analyzed. One-third of advertisements (32.5%) were for baked goods, snacks, and sweets -- products generally low in nutrient density. Two-thirds of the breakfast cereals were low in nutritional quality (64.6%). Beverages comprised 11% of the advertisements, fruit juices the highest proportion. Less than 3% of advertisements were for fruits and vegetables combined. No significant food product trends were evident across the five-year period. Food advertisements identified in parenting magazines were generally low in nutritional value. Additional research is necessary to determine the influence of food advertisements on parents' purchasing habits.

  13. Key Royale bridge five year evaluation.

    Science.gov (United States)

    2013-06-01

    This report describes the design, construction, instrumentation, and five-year evaluation of the Key Royale Bridge substructure. The primary focus was the evaluation of the implementation of highly reactive supplementary cementitious materials (SCM) ...

  14. Launching PPARC's five year strategy programme

    CERN Document Server

    2003-01-01

    "Over one hundred delegates from Parliament, Whitehall and Industry attended a reception on Tuesday night (25 November) to mark the launch the Particle Physics and Astronomy Research Council's (PPARC) Five Year Plan" (1 page).

  15. Transparency in ovarian cancer clinical trial results: ClinicalTrials.gov versus PubMed, Embase and Google scholar.

    Science.gov (United States)

    Roberto, Anna; Radrezza, Silvia; Mosconi, Paola

    2018-04-10

    In recent years the question of the lack of transparency in clinical research has been debated by clinicians, researchers, citizens and their representatives, authors and publishers. This is particularly important for infrequent cancers such as ovarian cancer, where treatment still gives disappointing results in the majority of cases. Our aim was to assess the availability to the public of results in ClinicalTrials.gov, and the frequency of non-publication of results in ClinicalTrials.gov and in PubMed, Embase and Google Scholar. We collected all trials on ovarian cancer identified as "completed status" in the ClinicalTrials.gov registry on 17 January 2017. We checked the availability of the results in ClinicalTrials.gov and systematically identified published manuscripts on results. Out of 2725 trials on ovarian cancer identified, 752 were classified as "completed status". In those closed between 2008 and 2015, excluding phase I, the frequency of results in ClinicalTrials.gov was 35%. Of the 752 completed studies the frequency of published results in PubMed, Embase or Google Scholar ranged from 57.9% to 69.7% in the last years. These findings show a lack of transparency and credibility of research. Citizens or patients' representatives, with the medical community, should continuously support initiatives to improve the publication and dissemination of clinical study results.

  16. Computing for magnetic fusion energy research: The next five years

    International Nuclear Information System (INIS)

    Mann, L.; Glasser, A.; Sauthoff, N.

    1991-01-01

    This report considers computing needs in magnetic fusion for the next five years. It is the result of two and a half years of effort by representatives of all aspects of the magnetic fusion community. The report also factors in the results of a survey that was distributed to the laboratories and universities that support fusion. There are four areas of computing support discussed: theory, experiment, engineering, and systems

  17. Eplerenone for early cardiomyopathy in Duchenne muscular dystrophy: results of a two-year open-label extension trial

    Directory of Open Access Journals (Sweden)

    Subha V. Raman

    2017-02-01

    Full Text Available Abstract Background Cardiomyopathy is a leading cause of morbidity and mortality in boys with Duchenne muscular dystrophy (DMD. We recently showed in a 12-month double-blind randomized controlled trial that adding eplerenone to background medical therapy was cardioprotective in this population. The objective of this study was to evaluate the safety and efficacy of longer-term eplerenone therapy in boys with DMD. Results Eleven subjects (phase 1 baseline median [range] age: 13 [7 – 25] years from the original 12-month trial at a single participating center were enrolled. Importantly, those who entered the extension study who had been on eplerenone previously were significantly older than those who had originally been on placebo (median age 10.5 vs. 18.0 years, p = 0.045. During an additional 24-month open-label extension study, all boys received eplerenone 25 mg orally once daily to treat preclinical DMD cardiomyopathy, defined as evident myocardial damage by late gadolinium enhancement cardiac magnetic resonance (LGE with preserved ejection fraction (EF. The threshold for potassium level, the primary safety measure, was not exceeded in any non-hemolyzed blood sample. Over 24 months, left ventricular (LV systolic strain, a more sensitive marker whose more negative values indicate greater contractility significantly improved (median change -4.4%, IQR -5.8 to -0.9% in younger subjects whereas older subjects’ strain remained stable without significant worsening or improvement (median change 0.2%, IQR -1.1 to 4.3%. EF and extent of myocardial damage by LGE remained stable in both groups over 2 years. Conclusions Eplerenone offers effective and safe cardioprotection for boys with DMD, particularly when started at a younger age. Eplerenone is a useful clinical therapeutic option, particularly if treatment is initiated earlier in life when cardiac damage is minimal. Trial registration http://ClinicalTrials.gov identifier NCT01521546

  18. Results of five years to open exposure of the Zn22Al2Cu alloy

    International Nuclear Information System (INIS)

    Hernandez, L.S.; Miranda, J.M.; Narvaez, L.

    1998-01-01

    It was studied the behavior of the Zn 2 2Al 2 Cu alloy within urban environment (ISO C3) and it is compared with that of galvanized steel (zinc) and aluminium at the same environment. The exposure included three annual exposures and other until for five years. The corrosion damage was evaluated by weight losses. The results confirm a greater corrosion for the ternary alloy compared with the galvanized steel. However, the obtained results through the Polarization resistance technique (Rp), utilizing a 0.1 M Na 2 SO 4 solution, indicated greater values for the corrosion products layer over the alloy with respect to galvanized. The formed corrosion products over the exposed samples by different periods were characterized by different techniques to estimate the protective properties out in the open. By means of X-ray diffraction were identified zinc and aluminium sulfates also alumina in the ternary alloy. The presence of alumina was confirmed by Raman spectroscopy. Through polarization curves and punctual analysis by X-ray dispersive energies (EDX) it was confirmed the enrichment of the aluminium surface by the preferential dissolution of zinc. (Author)

  19. Food Advertisements in Two Popular U.S. Parenting Magazines: Results of a Five-Year Analysis

    Science.gov (United States)

    Basch, Corey H.; Hammond, Rodney N.; Ethan, Danna; Samuel, Lalitha

    2014-01-01

    Obesity rates among American youth have prompted an examination of food advertisements geared towards children. Research indicates children’s high exposure to these advertisements and their influence on food preferences. Less is known about the presence of these advertisements in parenting magazines. This study’s objective was to examine prevalence of food advertisements in popular parenting magazines and identify products by USDA food category. We analyzed 116 issues of two popular U.S. parenting magazines across five years. All food and beverage advertisements for USDA Food Category were coded. Breakfast cereals were coded for nutritional quality. The coding took place at varied libraries in New Jersey, in the United States. A total of 19,879 food and beverage products were analyzed. One-third of advertisements (32.5%) were for baked goods, snacks, and sweets -- products generally low in nutrient density. Two-thirds of the breakfast cereals were low in nutritional quality (64.6%). Beverages comprised 11% of the advertisements, fruit juices the highest proportion. Less than 3% of advertisements were for fruits and vegetables combined. No significant food product trends were evident across the five-year period. Food advertisements identified in parenting magazines were generally low in nutritional value. Additional research is necessary to determine the influence of food advertisements on parents’ purchasing habits. PMID:24576378

  20. The Anglo-Scandinavian Cardiac Outcomes Trial lipid lowering arm: extended observations 2 years after trial closure

    DEFF Research Database (Denmark)

    Sever, Peter S; Poulter, Neil R; Dahlof, Bjorn

    2008-01-01

    Aims To determine the cardiovascular benefits in those originally assigned atorvastatin in the Anglo-Scandinavian Cardiac Outcomes Trial-2.2 years after closure of the lipid-lowering arm of the trial (ASCOT-LLA). Methods and results The Blood Pressure Lowering Arm of the ASCOT trial (ASCOT......-BPLA) compared two different antihypertensive treatment strategies on cardiovascular outcomes. ASCOT-LLA was a double-blind placebo-controlled trial of atorvastatin in those enrolled into ASCOT-BPLA with total cholesterol concentrations at baseline of ... enrolled in ASCOT-BPLA and 10 305 were further assigned either atorvastatin, 10 mg, or placebo. ASCOT-LLA was stopped prematurely after a median 3.3 years follow-up because of substantial cardiovascular benefits in those assigned atorvastatin. Trial physicians were invited to offer atorvastatin to all...

  1. Annex A1: cornerstone of the five-yearly review

    CERN Multimedia

    Staff Association

    2016-01-01

    As a reminder; the purpose of the five-yearly review is to review the financial and social conditions of all CERN personnel whether employed (MPE) or associated (MPA)! In December 2015, the CERN Council approved the package proposed by the Management. Early this year, and as final act of the 2015 five-yearly review, the CERN Council may decide, if necessary and appropriate, to review the procedures defined in Annex A1 and applicable to future five-yearly reviews. At the meeting of TREF (TRipartite Employment Forum)  in early March 2016 discussions will take place between all stakeholders (representatives of Member States, Management and the Staff Association) and Council will take a decision in June 2016, on the basis of the Management's recommendations. What does Annex A1 say and where can I find it? Annex A1 (Article S V 1.02) is a part of the Staff Rules and Regulations. This annex defines: The five-yearly review of the financial and social conditions of the staff, fellows and MPA; The a...

  2. Barriers in phase I cancer clinical trials referrals and enrollment: five-year experience at the Princess Margaret Hospital

    Directory of Open Access Journals (Sweden)

    Oza Amit M

    2006-11-01

    Full Text Available Abstract Background There is a paucity of literature on the referral outcome of patients seen in phase I trial clinics in academic oncology centres. This study aims to provide information on the accrual rate and to identify obstacles in the recruitment process. Methods A retrospective chart review was performed for all new patients referred and seen in the phase I clinic at the Princess Margaret Hospital between January 2000 and June 2005. Data on their demographics, medical history, and details of trial participation or non-entry were recorded. Results A total of 667 new phase I referrals were seen during the stated period. Of these patients, 197 (29.5% patients were enrolled into a phase I trial, and 64.5% of them started trial within 1 month of the initial visit. About a quarter (165 of 667 of the patients referred were deemed ineligible at their first visit, with the most frequent reasons for ineligibility being poor performance status, unacceptable bloodwork, too many prior treatments and rapid disease progression. The remaining 305 patients (45.7% were potentially eligible at their initial visit, but never entered a phase I trial. The main reasons for their non-entry were patient refusal, other treatment recommended first, and lack of available trials or trial spots. Conclusion This study provides information on the clinical realities underlying a referral to a phase I clinic and eventual trial enrollment. Better selection of patients, appropriate education of referring physicians, and opening phase I trials with fewer restrictions on some criteria such as prior therapy may enhance their recruitment rates.

  3. Suicide rates in five-year age-bands after the age of 60 years: the international landscape.

    Science.gov (United States)

    Shah, Ajit; Bhat, Ravi; Zarate-Escudero, Sofia; DeLeo, Diego; Erlangsen, Annette

    2016-01-01

    There is paucity of studies examining suicide rates in narrow five-year age-bands after the age of 60 years. This study examined suicide rates in eight five-year age-bands between the age of 60 and 99 years because this will allow more precise comparison between the young old (60-79 years) and the oldest old (80+ years) age groups. Data on the number of suicides (International Classification of Diseases - ICD-10 codes, X60-84) in each of the eight five-year age-bands between the age-bands 60-64 years and 95-99 years in both gender for as many years as possible from 2000 were ascertained from three sources: colleagues with access to national data, national statisics office websites and email contact with the national statistics offices. The population size for the corresponding years and age-bands was estimated for each country using data provided by the United Nations website. In men, suicide rates continued to increase for each of the seven five-year age-bands from 60-64 years to 90-94 years age-band, and then declined slightly for the 95-99 year age-band. In women, suicide rates continued to increase for each of the six five-year age-bands from 60-64 years to 85-89 years age-bands, and then declined slightly for the 90-94 years and 95-99 years age-bands. The overall global suicide rates for each of the eight five-year age-bands are sufficiently large for them to constitute a public health concern. This is especially important given the ongoing rise in the elderly population size and the paucity of data on risk and protective factors for suicide in the five-year age-bands after the age of 60 years.

  4. Diffraction dissociation: thirty five years after

    International Nuclear Information System (INIS)

    Zotov, N.P.; Tsarev, V.A.

    1988-01-01

    Review of the basic results and stages of studying one of the most interesting phenomena in high energy physics-diffraction dissociation (DD) of hadrons is presented. The review contains complete information concerning the basic experimental results and the most ''set'' DD theoretical models. Though the discussion focuses primarily on considering a single nucleon DD, this still allows one to fully describe the basic features of the phenomenon under investigation. The last part of the review is devoted to the most notable results obtained during DD experimental investigation in the last five years, which have not been reflected in the earlier published reviews. Signs of excited system parton structure and pomeron are clearly found in the new experimental data. It is underlined that DD mechanism understanding is closely connected with the solution of the confinement problem in the strong interaction theory and requires further experimental and theoretical investigations

  5. Five year survival analysis of an oxidised zirconium total knee arthroplasty.

    Science.gov (United States)

    Holland, Philip; Santini, Alasdair J A; Davidson, John S; Pope, Jill A

    2013-12-01

    Zirconium total knee arthroplasties theoretically have a low incidence of failure as they are low friction, hard wearing and hypoallergenic. We report the five year survival of 213 Profix zirconium total knee arthroplasties with a conforming all polyethylene tibial component. Data was collected prospectively and multiple strict end points were used. SF12 and WOMAC scores were recorded pre-operatively, at three months, at twelve months, at 3 years and at 5 years. Eight patients died and six were "lost to follow-up". The remaining 199 knees were followed up for five years. The mean WOMAC score improved from 56 to 35 and the mean SF12 physical component score improved from 28 to 34. The five year survival for failure due to implant related reasons was 99.5% (95% CI 97.4-100). This was due to one tibial component becoming loose aseptically in year zero. Our results demonstrate that the Profix zirconium total knee arthroplasty has a low medium term failure rate comparable to the best implants. Further research is needed to establish if the beneficial properties of zirconium improve long term implant survival. Copyright © 2012 Elsevier B.V. All rights reserved.

  6. Five-Year Wilkinson Microwave Anisotropy Probe Observations: Beam Maps and Window Functions

    Science.gov (United States)

    Hill, R. S.; Weiland, J. L.; Odegard, N.; Wollack, E.; Hinshaw, G.; Larson, D.; Bennett, C. L.; Halpern, M.; Page, L.; Dunkley, J.; Gold, B.; Jarosik, N.; Kogut, A.; Limon, M.; Nolta, M. R.; Spergel, D. N.; Tucker, G. S.; Wright, E. L.

    2009-02-01

    Cosmology and other scientific results from the Wilkinson Microwave Anisotropy Probe (WMAP) mission require an accurate knowledge of the beam patterns in flight. While the degree of beam knowledge for the WMAP one-year and three-year results was unprecedented for a CMB experiment, we have significantly improved the beam determination as part of the five-year data release. Physical optics fits are done on both the A and the B sides for the first time. The cutoff scale of the fitted distortions on the primary mirror is reduced by a factor of ~2 from previous analyses. These changes enable an improvement in the hybridization of Jupiter data with beam models, which is optimized with respect to error in the main beam solid angle. An increase in main-beam solid angle of ~1% is found for the V2 and W1-W4 differencing assemblies. Although the five-year results are statistically consistent with previous ones, the errors in the five-year beam transfer functions are reduced by a factor of ~2 as compared to the three-year analysis. We present radiometry of the planet Jupiter as a test of the beam consistency and as a calibration standard; for an individual differencing assembly, errors in the measured disk temperature are ~0.5%. WMAP is the result of a partnership between Princeton University and NASA's Goddard Space Flight Center. Scientific guidance is provided by the WMAP Science Team.

  7. 75 FR 34959 - Five-Year Review of Oil Pipeline Pricing Index

    Science.gov (United States)

    2010-06-21

    ...] Five-Year Review of Oil Pipeline Pricing Index June 15, 2010. AGENCY: Federal Energy Regulatory... comments on its five-year review of the oil pipeline pricing index established in Revisions to Oil Pipeline...-year review of the oil pricing index, the Commission adopted an index of PPI+1.3 for the five-year...

  8. 78 FR 26616 - Draft NOAA Five Year Research and Development Plan

    Science.gov (United States)

    2013-05-07

    ... DEPARTMENT OF COMMERCE Draft NOAA Five Year Research and Development Plan AGENCY: National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC). ACTION: Draft NOAA Five Year Research and Development Plan for Public Review. SUMMARY: NOAA's draft Five Year Research and Development...

  9. Five-Year Risk of Interval-Invasive Second Breast Cancer

    Science.gov (United States)

    Buist, Diana S. M.; Houssami, Nehmat; Dowling, Emily C.; Halpern, Elkan F.; Gazelle, G. Scott; Lehman, Constance D.; Henderson, Louise M.; Hubbard, Rebecca A.

    2015-01-01

    Background: Earlier detection of second breast cancers after primary breast cancer (PBC) treatment improves survival, yet mammography is less accurate in women with prior breast cancer. The purpose of this study was to examine women presenting clinically with second breast cancers after negative surveillance mammography (interval cancers), and to estimate the five-year risk of interval-invasive second cancers for women with varying risk profiles. Methods: We evaluated a prospective cohort of 15 114 women with 47 717 surveillance mammograms diagnosed with stage 0-II unilateral PBC from 1996 through 2008 at facilities in the Breast Cancer Surveillance Consortium. We used discrete time survival models to estimate the association between odds of an interval-invasive second breast cancer and candidate predictors, including demographic, PBC, and imaging characteristics. All statistical tests were two-sided. Results: The cumulative incidence of second breast cancers after five years was 54.4 per 1000 women, with 325 surveillance-detected and 138 interval-invasive second breast cancers. The five-year risk of interval-invasive second cancer for women with referent category characteristics was 0.60%. For women with the most and least favorable profiles, the five-year risk ranged from 0.07% to 6.11%. Multivariable modeling identified grade II PBC (odds ratio [OR] = 1.95, 95% confidence interval [CI] = 1.15 to 3.31), treatment with lumpectomy without radiation (OR = 3.27, 95% CI = 1.91 to 5.62), interval PBC presentation (OR = 2.01, 95% CI 1.28 to 3.16), and heterogeneously dense breasts on mammography (OR = 1.54, 95% CI = 1.01 to 2.36) as independent predictors of interval-invasive second breast cancers. Conclusions: PBC diagnosis and treatment characteristics contribute to variation in subsequent-interval second breast cancer risk. Consideration of these factors may be useful in developing tailored post-treatment imaging surveillance plans. PMID:25904721

  10. Five-yearly Review: What now? Is this the end?

    CERN Multimedia

    Association du personnel

    2006-01-01

    The CERN Staff Association has made every effort over the past months to devise and propose numerous solutions in the framework of the current five-yearly review. The Staff Association has done this in close collaboration with the staff members, through several polls which have all resulted in a massive rejection of the Management's position.

  11. One-Year Outcomes Following Directional Atherectomy of Infrapopliteal Artery Lesions: Subgroup Results of the Prospective, Multicenter DEFINITIVE LE Trial.

    Science.gov (United States)

    Rastan, Aljoscha; McKinsey, James F; Garcia, Lawrence A; Rocha-Singh, Krishna J; Jaff, Michael R; Noory, Elias; Zeller, Thomas

    2015-12-01

    To report a subgroup analysis of the prospective, multicenter, single-arm DEFINITIVE LE trial to assess the effectiveness of directional atherectomy for the treatment of infrapopliteal artery lesions at 1 year. In the DEFINITIVE LE trial, follow-up assessments occurred up to 1 year postprocedure. Of the 800 patients enrolled, 145 subjects with 189 infrapopliteal lesions met the criteria for this analysis. Seventy (48.3%) and 75 (51.7%) patients were suffering critical limb ischemia (CLI) and intermittent claudication, respectively; 68.3% (99/145) had diabetes. The mean lesion length was 58±44 mm (all lesions); 20.2% were occluded. The primary endpoint for patients with claudication was duplex ultrasound-derived primary patency, while for subjects with CLI it was freedom from major amputation of the target limb at 1 year. Endpoints and adverse events were independently assessed. Procedure success (≤30% residual stenosis) was achieved in 84% of treated lesions. The 1-year primary patency rate was 84% (claudicants 89.6% and CLI patients 78%, p=0.11), and the freedom from major amputation rate was 97.1% (claudicants 100% and CLI 93.8%, p=0.03). In both claudication and CLI patients, significant improvements in Rutherford category and objective measures of walking distance and quality of life were seen at 1 year in comparison to baseline. This study demonstrates that directional atherectomy in infrapopliteal arteries results in promising technical and clinical results at 1 year for claudicant as well as CLI patients. © The Author(s) 2015.

  12. A randomized controlled trial of Human Papillomavirus (HPV testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial

    Directory of Open Access Journals (Sweden)

    Smith Laurie W

    2010-03-01

    Full Text Available Abstract Background In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. Methods/Design HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5% were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%. In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%. Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. Trial Registration International Standard Randomised Controlled Trial Number Register, ISRCTN79347302

  13. Percutaneous laser disc decompression versus conventional microdiscectomy for patients with sciatica: Two-year results of a randomised controlled trial.

    Science.gov (United States)

    Brouwer, Patrick A; Brand, Ronald; van den Akker-van Marle, M Elske; Jacobs, Wilco Ch; Schenk, Barry; van den Berg-Huijsmans, Annette A; Koes, Bart W; Arts, Mark A; van Buchem, M A; Peul, Wilco C

    2017-06-01

    Background Percutaneous laser disc decompression is a minimally invasive treatment, for lumbar disc herniation and might serve as an alternative to surgical management of sciatica. In a randomised trial with two-year follow-up we assessed the clinical effectiveness of percutaneous laser disc decompression compared to conventional surgery. Materials and methods This multicentre randomised prospective trial with a non-inferiority design, was carried out according to an intent-to-treat protocol with full institutional review board approval. One hundred and fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were randomly allocated to percutaneous laser disc decompression ( n = 55) or conventional surgery ( n = 57). The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analogue scores for back and leg pain and the patient's report of perceived recovery. Results The primary outcome measures showed no significant difference or clinically relevant difference between the two groups at two-year follow-up. The re-operation rate was 21% in the surgery group, which is relatively high, and with an even higher 52% in the percutaneous laser disc decompression group. Conclusion At two-year follow-up, a strategy of percutaneous laser disc decompression, followed by surgery if needed, resulted in non-inferior outcomes compared to a strategy of microdiscectomy. Although the rate of reoperation in the percutaneous laser disc decompression group was higher than expected, surgery could be avoided in 48% of those patients that were originally candidates for surgery. Percutaneous laser disc decompression, as a non-surgical method, could have a place in the treatment arsenal of sciatica caused by contained herniated discs.

  14. Five-Yearly Review 2010 : Confirmation that our salaries are going downhill

    CERN Multimedia

    Staff Association

    2010-01-01

    A general review of our financial and social conditions takes place every five years: “the five-yearly review”, whose principles and procedures are described in Annex A1 of the Staff Rules and Regulations. The purpose of the five-yearly review is to ensure that the financial and social conditions offered by the Organization allow it to recruit and retain from all its Member States staff members of the highest competence and integrity required for the execution of its mission. The five-yearly review must include basic remuneration (the basic salaries of staff members, the stipends of fellows, and the subsistence allowances of associated members of the personnel) and may include any other financial or social conditions. Start of the 2010 five-yearly review and data collection As we wrote in Echo no. 80, CERN Council approved the document CERN/2862 for the 2010 five-yearly review (hereinafter 2010 5YR) at its meeting on 19th June 2009. This was the Management’s proposal which...

  15. Sociohydrology: Where are we five years later?

    Science.gov (United States)

    Guneralp, I.; Weyand, S.; Guneralp, B.

    2017-12-01

    Studies exploring the nature of human-water systems and methodologies aiming to integrate social and biophysical cycles have existed long before the term `sociohydrology' was officially introduced in a 2012 article. Despite criticisms since this first publication, the term has promoted research towards a wholistic understanding of the dynamics of coupled human-water systems. The declaration of the 2013-2022 Scientific Decade as Panta Rhei - Everything Flows recognized the importance of interactions and feedbacks between hydrological and social systems: a call to broaden the horizons of sociohydrology. Five years have passed since the field began, and there is a need to analyze the growing body of literature and determine which steps to take next. This study will perform a meta-analysis of the literature pertaining to the field of sociohydrology from its coinage in 2012 until the present year. Our goal is to identify developing trends in the application of the sociohydrologic framework, study foci, criticisms, and the authors behind them. We have obtained 65 publications relating to `sociohydrology' or `socio-hydrology' and 34 additional publications identified solely by the "KeyWords PLUS" function on Web of Science. In addition to independent analyses, we will compare the two datasets for similarities and significant differences. Our interests include the areas of application - both geographically and in subject matter - and authorship diversity among others. These results will supplement the conversation on sociohydrology by discerning how the field has evolved over the past five years. The results will identify shortcomings in the scope of the current literature, potential prevailing biases, and criticisms of the field, in addition to unifying thought and novel application. It will finish by offering a direction for the research community to continue developing.

  16. Outcome of the 2015 five-yearly review: decision time

    CERN Multimedia

    Staff Association

    2015-01-01

    To ensure that CERN remains a centre of excellence in the field of fundamental research, the Organization verifies every five years with the help of a Five-yearly review procedure whether the financial and social conditions which it proposes to its staff allow it to recruit and retain Staff Members of the highest competence and integrity required for the execution of its mission and coming from all Member States. For Fellows these conditions should remain attractive compared with those in comparable research institutions, while for Associated members of personnel the conditions should allow it to host them in its research facilities taking into account the highest cost-of-living level in the local region of the Organization. Annex A1 of the CERN Staff Rules prescribes the principles of how to manage this Five-Yearly process. Getting ready In order to prepare the 2015 Five-yearly review and to help define the topics which had to be decided by the CERN Council in June 2014, the Staff Association has organized ...

  17. Prosthodontic maintenance of overdentures on zirconia implants: 1-year results of a randomized controlled trial.

    Science.gov (United States)

    Osman, Reham B; Ma, Sunyoung

    2014-01-01

    The purpose of this study was to determine the prosthodontic outcomes of one-piece zirconia implants and their attachment systems in edentulous participants with maxillary and mandibular overdentures after 1 year of a randomized controlled trial. Random allocation of 24 edentulous participants (age range: 45 to 86 years) into titanium (control) or zirconia (test) groups using onepiece implants and a planned unsplinted prosthodontic design was performed. Four maxillary implants (one midpalatal; three anterior crestal) and three mandibular implants (one midsymphyseal; two bilateral distal) were conventionally loaded with the overdentures. Similar attachment systems were used throughout: ball abutment-type patrices (diameter: 2.25 to 3.1 mm as part of the one-piece implants) and custommade plastic matrices (with or without metal housings depending on the patrix size). Prosthodontic outcomes were documented during the first year of the clinical trial. Following three deaths and two dropouts, there were 19 participants who were available at the 1-year recall. Of these participants, 3 had early maxillary implant failure and had to be converted to conventional maxillary complete dentures opposing mandibular implant overdentures. There were 79 maintenance events, 34 in the titanium (control) group and 45 in the zirconia (test) group. Patrix loss occurred as a result of three zirconia implant fractures (one mandibular and two crestal maxillary implants). Maintenance events were principally the replacement of matrices and overdenture fracture. Although relines and replacement overdentures also occurred, overall there were no significant differences in prosthodontic maintenance between the control and test groups. A six-field prosthodontic-success analysis table showed no statistically significant difference between the two groups; however, 50% of participants in each group were allocated to the retreatment (repair) field, which produced a low prosthodontic success rate

  18. Effectiveness of Strategy Training for Struggling English Language Students: Profiles and Results of a Five-year Study

    Science.gov (United States)

    Taylor, Josephine A.; Gomez, Julio Cesar; Quintero, Gloria; Nausa, Ricardo; Rey, Luz Libia

    2011-01-01

    This study examines a group of approximately 1,100 English as a foreign language students who attended a tutoring program dedicated to training learners in study skills and language learning strategies. The study covers a five-year period of time during which the tutoring program remained consistent in its focus and organization. Students…

  19. 75 FR 80300 - Five-Year Review of Oil Pipeline Pricing Index

    Science.gov (United States)

    2010-12-22

    ...] Five-Year Review of Oil Pipeline Pricing Index Issued December 16, 2010. AGENCY: Federal Energy... five-year review of the oil pricing index, established in Order No. 561. After consideration of the... period commencing July 1, 2011. \\1\\ Five-Year Review of Oil Pipeline Pricing Index, 75 FR 34959 (June 21...

  20. Effect of therapy on five- and ten-year survival of malignant melanoma patients

    International Nuclear Information System (INIS)

    Siffnerova; Bustova; Zikmund

    1989-01-01

    The results are reported of five-year and ten-year survival of malignant melanoma patients treated postoperatively by actinotherapy. In patients where lymph flow was not apparent, 2.5 Gy of daily doses of electron irradiation from a 6-8 MeV betatron were used centred on the scar. The total dose was 60 Gy. Where the lymph flow could be identified, cobalt or cesium sources were used to deliver a total dose of 50 Gy in 2.5 Gy daily. Both five-year and ten-year survival was significantly better than in patients treated with surgery only, without irradiation. 55% of the patients on combined management survived for more than 5 years, 86% of them without relapses. 41% patients survived for 10 years, of which 92% without relapse. In contrast, the corresponding figures for the patients treated with surgery only were 42% and 71% respectively for the five-year survival, and 26% and 70% respectively for the ten-year survival. (L.O.). 3 figs., 2 tabs

  1. Significant achievements in '10th five-year plan' period and primary guidance in '11th five-year plan' period on uranium exploration

    International Nuclear Information System (INIS)

    Zhang Jindai; Li Youliang; Jian Xiaofei; Peng Xinjian; Jiang Deying

    2007-01-01

    During the '10th five-year-plane' period, uranium resource had attracted high attention and concentration from related organization of the CCPC and the central government because of the state's manifestation on the development goal for nuclear power, efforts on uranium research and exploration were intensified accordingly. In that five years, both uranium exploration, regional assessment and prognostication for the Mesozoic-Cenozoic basin in North China and research on uranium metallogeny theory and prospecting method had made fairly great progress and reached important fruits. Due to the improvement of prospecting theory and technology for ISL amenable sandstone hosted U-deposits, uranium exploration efficiency was great enhanced and had prompted the sustainable development for China's uranium exploration. This paper have briefly expounded the general deploy for the uranium geology research and exploration in the '11th five-year plan' period. (authors)

  2. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial.

    Science.gov (United States)

    Wells, John A; Glassman, Adam R; Ayala, Allison R; Jampol, Lee M; Bressler, Neil M; Bressler, Susan B; Brucker, Alexander J; Ferris, Frederick L; Hampton, G Robert; Jhaveri, Chirag; Melia, Michele; Beck, Roy W

    2016-06-01

    To provide 2-year results comparing anti-vascular endothelial growth factor (VEGF) agents for center-involved diabetic macular edema (DME) using a standardized follow-up and retreatment regimen. Randomized clinical trial. Six hundred sixty participants with visual acuity (VA) impairment from DME. Randomization to 2.0-mg aflibercept, 1.25-mg repackaged (compounded) bevacizumab, or 0.3-mg ranibizumab intravitreous injections performed up to monthly using a protocol-specific follow-up and retreatment regimen. Focal/grid laser photocoagulation was added after 6 months if DME persisted. Visits occurred every 4 weeks during year 1 and were extended up to every 4 months thereafter when VA and macular thickness were stable. Change in VA, adverse events, and retreatment frequency. Median numbers of injections were 5, 6, and 6 in year 2 and 15, 16, and 15 over 2 years in the aflibercept, bevacizumab, and ranibizumab groups, respectively (global P = 0.08). Focal/grid laser photocoagulation was administered in 41%, 64%, and 52%, respectively (aflibercept vs. bevacizumab, P 0.10, for pairwise comparisons). Anti-Platelet Trialists' Collaboration (APTC) events occurred in 5% with aflibercept, 8% with bevacizumab, and 12% with ranibizumab (global P = 0.047; aflibercept vs. bevacizumab, P = 0.34; aflibercept vs. ranibizumab, P = 0.047; ranibizumab vs. bevacizumab, P = 0.20; global P = 0.09 adjusted for potential confounders). All 3 anti-VEGF groups showed VA improvement from baseline to 2 years with a decreased number of injections in year 2. Visual acuity outcomes were similar for eyes with better baseline VA. Among eyes with worse baseline VA, aflibercept had superior 2-year VA outcomes compared with bevacizumab, but superiority of aflibercept over ranibizumab, noted at 1 year, was no longer identified. Higher APTC event rates with ranibizumab over 2 years warrants continued evaluation in future trials. Copyright © 2016 American Academy of Ophthalmology. All rights

  3. BAYESIAN ANALYSIS OF WHITE NOISE LEVELS IN THE FIVE-YEAR WMAP DATA

    International Nuclear Information System (INIS)

    Groeneboom, N. E.; Eriksen, H. K.; Gorski, K.; Huey, G.; Jewell, J.; Wandelt, B.

    2009-01-01

    We develop a new Bayesian method for estimating white noise levels in CMB sky maps, and apply this algorithm to the five-year Wilkinson Microwave Anisotropy Probe (WMAP) data. We assume that the amplitude of the noise rms is scaled by a constant value, α, relative to a pre-specified noise level. We then derive the corresponding conditional density, P(α | s, C l , d), which is subsequently integrated into a general CMB Gibbs sampler. We first verify our code by analyzing simulated data sets, and then apply the framework to the WMAP data. For the foreground-reduced five-year WMAP sky maps and the nominal noise levels initially provided in the five-year data release, we find that the posterior means typically range between α = 1.005 ± 0.001 and α = 1.010 ± 0.001 depending on differencing assembly, indicating that the noise level of these maps are biased low by 0.5%-1.0%. The same problem is not observed for the uncorrected WMAP sky maps. After the preprint version of this letter appeared on astro-ph., the WMAP team has corrected the values presented on their web page, noting that the initially provided values were in fact estimates from the three-year data release, not from the five-year estimates. However, internally in their five-year analysis the correct noise values were used, and no cosmological results are therefore compromised by this error. Thus, our method has already been demonstrated in practice to be both useful and accurate.

  4. Incidence, patterns and severity of reported unintentional injuries in Pakistan for persons five years and older: results of the National Health Survey of Pakistan 1990–94

    Directory of Open Access Journals (Sweden)

    Qureshi Huma I

    2007-07-01

    Full Text Available Abstract Background National level estimates of injuries are not readily available for developing countries. This study estimated the annual incidence, patterns and severity of unintentional injuries among persons over five years of age in Pakistan. Methods National Health Survey of Pakistan (NHSP 1990–94 is a nationally representative survey of the household. Through a two-stage stratified design, 18, 315 persons over 5 years of age were interviewed to estimate the overall annual incidence, patterns and severity of unintentional injuries for males and females in urban and rural areas over the preceding one year. Weighted estimates were computed adjusting for complex survey design using surveyfreq and surveylogistic option of SAS 9.1 software. Results The overall annual incidence of all unintentional injuries was 45.9 (CI: 39.3–52.5 per 1000 per year; 59.2 (CI: 49.2–69.2 and 33.2 (CI: 27.0–39.4 per 1000 per year among males and females over five years of age, respectively. An estimated 6.16 million unintentional injuries occur in Pakistan annually among persons over five years of age. Urban and rural injuries were 55.9 (95% CI: 48.1–63.7 and 41.2 (95% CI: 32.2–50.0 per 1000 per year, respectively. The annual incidence of injuries due to falls were 22.2 (95% CI: 18.0–26.4, poisoning 3.3 (95%CI: 0.5–6.1 and burn was 1.5 (95%CI: 0.9–2.1 per 1000 per year. The majority of injuries occurred at home 19.2 (95%CI: 16.0–22.4 or on the roads 17.0 (95%CI: 13.8–20.2. Road traffic/street, school and urban injuries were more likely to result in handicap. Conclusion There is high burden of unintentional injuries among persons over five years of age in Pakistan. These results are useful to plan further studies and prioritizing prevention programs on injuries nationally and other developing countries with similar situation.

  5. Radiotherapy and chemotherapy in the treatment of head and neck cancer: results after five years of a randomized study

    Energy Technology Data Exchange (ETDEWEB)

    Santarelli, M.; Raffetto, N.; Torcia, P.; Vitturini, A.; Tombolini, V.; Maurizi Enrici, R. [Istituto di radiologia Universita Roma ' ' La Sapienza' ' , Rome (Italy)

    1999-11-01

    Purpose: this study was undertaken to evaluate the efficacy of two regimens of chemoradiotherapy in the treatment of locally advanced head and neck cancer. Methods: from 1992 to 1997, 127 patients with locally advanced head and neck cancer (stage III-IV) were randomized. Sixty-six patients (group a), 42 male and 24 female, with a median age of 48 years (range 40-72) received during radiotherapy two courses (1.-6. week) of chemotherapy with carbo-platin (300 mg/m{sup 2} day 1) and etoposide (60 mg/m{sup 2} days 1 to 3). Sixty-one patients (group b), 40 male and 21 female, with a median age of 51 years (range 42-69) received two cycles of chemotherapy with 5 FU (750 mg/m{sup 2} days 1 to 5) and MIT C ( 10 mg/m{sup 2} day 1). The median dose of radiotherapy was 60 Gy (range 55-66 Gy) 180 cGy /d 5w. Results: the actuarial five-year survival rate(Kaplan-Meier) was 38 % for group a (CBDCA+etoposide+RT) and 25 % for group b (5FU+MIT C+RT). The difference was statistically significant (p = 0.036). Toxicity group a: mucositis G III in 41 patients and G IV in 16; dysphagia G III in 46 patients and IV in 5; leukopenia in 24 patients; 28 patients required nutritional therapy. Toxicity group b: mucositis G III in 38 patients and G IV in 17; dysphagia G III in 48 patients and G IV in 3; leukopenia in 23 patients; 25 patients needed nutritional therapy. Conclusions: the data of the actuarial survival five-year rate suggest that concomitant chemotherapy in group a (CBDCA+etoposide+RT) is better than the concomitant chemotherapy in group b (5FU+MIT C+RT). (author)

  6. Radiotherapy and chemotherapy in the treatment of head and neck cancer: results after five years of a randomized study

    International Nuclear Information System (INIS)

    Santarelli, M.; Raffetto, N.; Torcia, P.; Vitturini, A.; Tombolini, V.; Maurizi Enrici, R.

    1999-01-01

    Purpose: this study was undertaken to evaluate the efficacy of two regimens of chemoradiotherapy in the treatment of locally advanced head and neck cancer. Methods: from 1992 to 1997, 127 patients with locally advanced head and neck cancer (stage III-IV) were randomized. Sixty-six patients (group a), 42 male and 24 female, with a median age of 48 years (range 40-72) received during radiotherapy two courses (1.-6. week) of chemotherapy with carbo-platin (300 mg/m 2 day 1) and etoposide (60 mg/m 2 days 1 to 3). Sixty-one patients (group b), 40 male and 21 female, with a median age of 51 years (range 42-69) received two cycles of chemotherapy with 5 FU (750 mg/m 2 days 1 to 5) and MIT C ( 10 mg/m 2 day 1). The median dose of radiotherapy was 60 Gy (range 55-66 Gy) 180 cGy /d 5w. Results: the actuarial five-year survival rate (Kaplan-Meier) was 38 % for group a (CBDCA+etoposide+RT) and 25 % for group b (5FU+MIT C+RT). The difference was statistically significant (p = 0.036). Toxicity group a: mucositis G III in 41 patients and G IV in 16; dysphagia G III in 46 patients and IV in 5; leukopenia in 24 patients; 28 patients required nutritional therapy. Toxicity group b: mucositis G III in 38 patients and G IV in 17; dysphagia G III in 48 patients and G IV in 3; leukopenia in 23 patients; 25 patients needed nutritional therapy. Conclusions: the data of the actuarial survival five-year rate suggest that concomitant chemotherapy in group a (CBDCA+etoposide+RT) is better than the concomitant chemotherapy in group b (5FU+MIT C+RT). (author)

  7. The EPIC nitinol stent system in the treatment of iliac artery lesions: one-year results from the ORION clinical trial.

    Science.gov (United States)

    Clair, Daniel G; Adams, Julie; Reen, Bernard; Feldman, Robert; Starr, Jean; Diaz-Cartelle, Juan; Dawkins, Keith D

    2014-04-01

    To report the 1-year results of a pivotal study for a new-generation nitinol stent for the treatment of iliac atherosclerotic lesions. The ORION trial (ClinicalTrials.gov identifier NCT00896337) was a single-arm, non-randomized, prospective, multicenter clinical trial that enrolled 125 patients (81 men; mean age 61.1±9.3 years) implanted with the EPIC self-expanding nitinol stent system in 166 de novo or restenotic iliac artery lesions ≤13 cm long. The primary endpoint was the 9-month major adverse event rate [i.e., device- or procedure-related death within 30 days, myocardial infarction during the index hospitalization, target vessel revascularization (TVR), or index limb amputation]. Follow-up occurred at hospital discharge and at 1, 9, and 12 months. An independent core laboratory evaluated ultrasound results at 1, 9, and 12 months. The primary endpoint met the prespecified performance goal, with only 3.4% (4/117) of patients experiencing a major adverse event by 9 months (p<0.0001). By 12 months, 6 (5.4%) of 111 patients had TVR; none had an index limb amputation. The ankle-brachial index, Walking Impairment Questionnaire, and Rutherford classifications all showed sustained improvements through 12 months. Primary patency was 94.4% with comparable results for lesions classified as complex (TASC II C/D 95.5%) or non-complex (TASC II A/B 95.0%). The EPIC stent system demonstrated safety and effectiveness through 12 months, including improvements for complex lesions. The EPIC stent is a viable alternative to surgery for patients with either complex or non-complex lesions.

  8. Centre-based day care for children younger than five years of age in high-income countries.

    Science.gov (United States)

    van Urk, Felix C; Brown, Taylor W; Waller, Rebecca; Mayo-Wilson, Evan

    2014-09-23

    A large proportion of children younger than five years of age in high-income countries experience significant non-parental care. Centre-based day care services may influence the development of children and the economic situation of parents. To assess the effects of centre-based day care without additional interventions (e.g. psychological or medical services, parent training) on the development and well-being of children and families in high-income countries (as defined by the World Bank 2011). In April 2014, we searched CENTRAL, Ovid MEDLINE, EMBASE, PsycINFO, the Education Resources Information Center (ERIC) and eight other databases. We also searched two trials registers and the reference lists of relevant studies. We included randomised and quasi-randomised controlled trials of centre-based day care for children younger than five years of age. We excluded studies that involved co-interventions not directed toward children (e.g. parent programmes, home visits, teacher training). We included the following outcomes: child cognitive development (primary outcome), child psychosocial development, maternal and family outcomes and child long-term outcomes. Two review authors independently assessed the risk of bias and extracted data from the single included study. We contacted investigators to obtain missing information. We included in the review one trial, involving 120 families and 143 children. Risk of bias was high because of contamination between groups, as 63% of control group participants accessed day care services separate from those offered within the intervention. No evidence suggested that centre-based day care, rather than no treatment (care at home), improved or worsened children's cognitive ability (Griffiths Mental Development Scale, standardised mean difference (SMD) 0.34, 95% confidence interval (CI) -0.01 to 0.69, 127 participants, 1 study, very low-quality evidence) or psychosocial development (parental report of abnormal development, risk ratio (RR

  9. Why are clinicians not embracing the results from pivotal clinical trials in severe sepsis? A bayesian analysis.

    Directory of Open Access Journals (Sweden)

    Andre C Kalil

    Full Text Available BACKGROUND: Five pivotal clinical trials (Intensive Insulin Therapy; Recombinant Human Activated Protein C [rhAPC]; Low-Tidal Volume; Low-Dose Steroid; Early Goal-Directed Therapy [EGDT] demonstrated mortality reduction in patients with severe sepsis and expert guidelines have recommended them to clinical practice. Yet, the adoption of these therapies remains low among clinicians. OBJECTIVES: We selected these five trials and asked: Question 1--What is the current probability that the new therapy is not better than the standard of care in my patient with severe sepsis? Question 2--What is the current probability of reducing the relative risk of death (RRR of my patient with severe sepsis by meaningful clinical thresholds (RRR >15%; >20%; >25%? METHODS: Bayesian methodologies were applied to this study. Odds ratio (OR was considered for Question 1, and RRR was used for Question 2. We constructed prior distributions (enthusiastic; mild, moderate, and severe skeptic based on various effective sample sizes of other relevant clinical trials (unfavorable evidence. Posterior distributions were calculated by combining the prior distributions and the data from pivotal trials (favorable evidence. MAIN FINDINGS: Answer 1--The analysis based on mild skeptic prior shows beneficial results with the Intensive Insulin, rhAPC, and Low-Tidal Volume trials, but not with the Low-Dose Steroid and EGDT trials. All trials' results become unacceptable by the analyses using moderate or severe skeptic priors. Answer 2--If we aim for a RRR>15%, the mild skeptic analysis shows that the current probability of reducing death by this clinical threshold is 88% for the Intensive Insulin, 62-65% for the Low-Tidal Volume, rhAPC, EGDT trials, and 17% for the Low-Dose Steroid trial. The moderate and severe skeptic analyses show no clinically meaningful reduction in the risk of death for all trials. If we aim for a RRR >20% or >25%, all probabilities of benefits become lower

  10. AMBULATORY CARE - SENSITIVE CONDITIONS IN CHILDREN UNDER FIVE YEARS

    Directory of Open Access Journals (Sweden)

    Maria Aparecida Araújo Figueiredo

    2013-05-01

    Full Text Available Objective:analyzethe extent to which the incidence rate of primary care sensitivehospitalizations in children under five years is influenced by the percentage of coverage of theprimary care.Methods:This was a cross-sectional ecological study that combines coverage ofprimary careand theambulatorycare-sensitiveconditionsin 2000 and 2010. We used data from theHospital Information System (HIS and the Information System of Primary Care (SIAB.Results:The data revealed that the increased coverage providedprimary carereductionrateofhospitalization diseases studied. In 2000 the reduction was greater for gastroenteritis (51% inchildren under 01 years and 30% in children 01-04 years in 2010 for respiratory diseases (51% inchildren under 01years and 33% in children aged 01-04 years.Conclusion:we found an association between the coverage ofprimary careand admission rates, however seem to affect othervariables, suggesting the need for further studies.

  11. Food supplementation for improving the physical and psychosocial health of socio-economically disadvantaged children aged three months to five years.

    Science.gov (United States)

    Kristjansson, Elizabeth; Francis, Damian K; Liberato, Selma; Benkhalti Jandu, Maria; Welch, Vivian; Batal, Malek; Greenhalgh, Trish; Rader, Tamara; Noonan, Eamonn; Shea, Beverley; Janzen, Laura; Wells, George A; Petticrew, Mark

    2015-03-05

    Undernutrition contributes to five million deaths of children under five each year. Furthermore, throughout the life cycle, undernutrition contributes to increased risk of infection, poor cognitive functioning, chronic disease, and mortality. It is thus important for decision-makers to have evidence about the effectiveness of nutrition interventions for young children. Primary objective1. To assess the effectiveness of supplementary feeding interventions, alone or with co-intervention, for improving the physical and psychosocial health of disadvantaged children aged three months to five years.Secondary objectives1. To assess the potential of such programmes to reduce socio-economic inequalities in undernutrition.2. To evaluate implementation and to understand how this may impact on outcomes.3. To determine whether there are any adverse effects of supplementary feeding. We searched CENTRAL, Ovid MEDLINE, PsycINFO, and seven other databases for all available years up to January 2014. We also searched ClinicalTrials.gov and several sources of grey literature. In addition, we searched the reference lists of relevant articles and reviews, and asked experts in the area about ongoing and unpublished trials. Randomised controlled trials (RCTs), cluster-RCTs, controlled clinical trials (CCTs), controlled before-and-after studies (CBAs), and interrupted time series (ITS) that provided supplementary food (with or without co-intervention) to children aged three months to five years, from all countries. Adjunctive treatments, such as nutrition education, were allowed. Controls had to be untreated. Two or more review authors independently reviewed searches, selected studies for inclusion or exclusion, extracted data, and assessed risk of bias. We conducted meta-analyses for continuous data using the mean difference (MD) or the standardised mean difference (SMD) with a 95% confidence interval (CI), correcting for clustering if necessary. We analysed studies from low- and middle

  12. The Chernobyl accident - five years later

    International Nuclear Information System (INIS)

    Mueck, K.

    1991-06-01

    At the fifth anniversary of the Chernobyl accident the initial situation at that time, the control of the consequences to Austria in the present light, as well as the knowledge gained from the accident and its consequences are described. A final estimate and appraisal of the total population dose by the accident alloted according to the individual exposure pathways and the dose reductions due to countermeasures by the authorities are given. The dose reduction in the following years is described. Five years later the external exposure was reduced to about 6 % of the values of the first year, the ingestion dose to about 5 % of the first-year-values. Finally, the current radiation situation is described and the dose contribution by foodstuff with elevated activity concentration is estimated. Also the consequences from the experience and knowledge obtained by the accident are described. (author)

  13. Parapneumonic effusions in children: five years’ experience

    Directory of Open Access Journals (Sweden)

    Atilla Cifci

    2017-12-01

    Full Text Available Aim: Most severe complication of respiratory tract infections that causing morbidity and mortality in children is parapneumonic effusion(PPE. PPE is a pleural exudate that is related with primary pneumonia. The early and appropriate antibiotic treatment is very important in follow-up of patients who are diagnosed as parapneumonic effusion and also the timing of interventional and surgical treatment is important to decrease morbidity and mortalitiy in whom clinical and laboratory findings are not cured enough. Materials and Methods: In this study, the clinical and laboratory findings of parapneumonic effusion one hundred patients applied to one center in five years time are discussed. Results: The mean age of patients were 52 months(1.5-156, 52 were male(52%.The 71% of patients were smaller than five years old. The mean duration of hospitalization of patients were 19.6 days(1-45 days. Most frequent spymptom in application was fever, most frequent sign were tachycardia and retractions, most frequent laboratory anormality was high white blood count. The most frequent microorganism in pleural fluid culture was S.aureus. Conclusion: The determination of pathogens causing parapneumonic effusions in our country is very important for starting most suitable treatment early and to decrease morbidity and mortality. [J Contemp Med 2017; 7(4.000: 340-347

  14. Five-year results from a prospective multicentre study of percutaneous pulmonary valve implantation demonstrate sustained removal of significant pulmonary regurgitation, improved right ventricular outflow tract obstruction and improved quality of life

    DEFF Research Database (Denmark)

    Hager, Alfred; Schubert, Stephan; Ewert, Peter

    2017-01-01

    . The EQ-5D quality of life utility index and visual analogue scale scores were both significantly improved six months post PPVI and remained so at five years. CONCLUSIONS: Five-year results following PPVI demonstrate resolved moderate or severe pulmonary regurgitation, improved right ventricular outflow...

  15. State of logistics - a five-year review

    CSIR Research Space (South Africa)

    Ittmann, HW

    2009-07-01

    Full Text Available The state of logistics survey makes it possible to analyse and show trends over the past five years. This relates to quantitative and qualitative logistics issues that were not possible when this survey started in 2004. The paper will show...

  16. Power generation in the 12-th five-year plan

    International Nuclear Information System (INIS)

    Troitskij, A.A.

    1986-01-01

    The state of electric power generation in the 11-th five-year plan is summed up. Perspectives of development of heat and electric power generation in the 12-th five-year plan are considered. Thermal power generation of NPPs in 1990 will increase by a factor of 8.4 as compared with 1975. The NPP development will be mainly realized on the basis of the WWER-1000 type reactors. It is planned to commission fast reactors of up to 800 MW

  17. Five-year outcome after implantation of zotarolimus- and everolimus-eluting stents in randomized trial participants and nonenrolled eligible patients : A secondary analysis of a randomized clinical trial

    NARCIS (Netherlands)

    Von Birgelen, Clemens; Van Der Heijden, Liefke C.; Basalus, Mounir Welson Zakhary; Kok, Marlies M.; Sen, Hanim; Louwerenburg, Hans W.; van Houwelingen, Gert K.; Stoel, Martin G.; de Man, Frits H.A.F.; Linssen, Gerard C.M.; Tandjung, Kenneth; Doggen, Carine J.M.; Van Der Palen, Job; Löwik, Marije M.

    2017-01-01

    IMPORTANCE: Long-term follow-up after a clinical trial of 2 often-used, newer-generation drug-eluting stents (DESs) in a broad patient population is of interest. Comprehensive long-term outcome of eligible nonenrolled patients has never been reported. OBJECTIVE: To assess 5-year safety and efficacy

  18. Transition to low carbon energy policies in China-from the Five-Year Plan perspective

    International Nuclear Information System (INIS)

    Yuan Xueliang; Zuo Jian

    2011-01-01

    Energy policy plays a critical role not only in the energy development, but also in the social and environmental aspects of a nation. Five-Year Plan for National Economic and Social Development is one of the most important government plans, which documents the national strategy during that period. This study presents a critical review of 12 Five-Year Plans that have been released by the Chinese central government in last 58 years. In particular, the recently released Twelfth Five-Year Plan is reviewed. The results clearly show a pattern of increasingly level of attention of Chinese government to energy efficiency improvement, air pollutant emission reduction, new and renewable energy development, carbon dioxide emission and climate change. - Highlights: → Critical review of the energy related contents in the 12 Five-Year Plans. → Energy policy of China is focusing on energy efficiency, new and renewable energy. → China is improving the capability of dealing with CO 2 emission and climate change. → China is on transition to low carbon energy policies for a sustainable development.

  19. e+e- physics at PETRA - the first five years

    International Nuclear Information System (INIS)

    Sau Lan Wu

    1984-03-01

    PETRA (Positron-Electron Tandem Ring Accelerator) is located at DESY in Hamburg, Germany, and is the highest energy electron-positron storage ring in the world. This report gives a global review of the experimental investigations carried out at PETRA for the first five years of its operation beginning in 1978 by the five Collaborations CELLO, JADE, MARK J, PLUTO and TASSO. The physics objectives in the original proposals have largely been fullfilled. The emphasis of this review, based mainly on journal publications before July 15, 1983 (the fifth anniversary of the first successful storage on an electron beam at PETRA), is on the physics results, ranging over strong, electromagnetic and weak interactions. The topics covered include quark and gluon physics, inclusive particle production, electroweak interference, two-photon physics, and search for new particles. Although cited for comparison, no attempt has been made for any systematic coverage of the corresponding results from PEP of SLAC. (orig.)

  20. A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial)

    International Nuclear Information System (INIS)

    Ogilvie, Gina S; Cook, Darrel A; Mei, Wendy; Stuart, Gavin CE; Franco, Eduardo L; Coldman, Andrew J; Niekerk, Dirk J van; Krajden, Mel; Martin, Ruth E; Ehlen, Thomas G; Ceballos, Kathy; Peacock, Stuart J; Smith, Laurie W; Kan, Lisa

    2010-01-01

    In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. International Standard Randomised Controlled Trial Number Register, ISRCTN79347302

  1. Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis

    Directory of Open Access Journals (Sweden)

    Nunley PD

    2017-09-01

    Full Text Available Pierce D Nunley,1 Vikas V Patel,2 Douglas G Orndorff,3 William F Lavelle,4 Jon E Block,5 Fred H Geisler6 1Spine Institute of Louisiana, Shreveport, LA, 2The Spine Center, University of Colorado Hospital, Denver, CO, 3Spine Colorado, Mercy Regional Hospital, Durango, CO, 4Upstate Bone and Joint Center, East Syracuse, NY, 5Independent Consultant, San Francisco, CA, 6Independent Consultant, Chicago, IL, USA Background: Lumbar spinal stenosis is the most common indication for spine surgery in older adults. Interspinous process decompression (IPD using a stand-alone spacer that functions as an extension blocker offers a minimally invasive treatment option for intermittent neurogenic claudication associated with spinal stenosis.Methods: This study evaluated the 5-year clinical outcomes for IPD (Superion® from a randomized controlled US Food and Drug Administration (FDA noninferiority trial. Outcomes included Zurich Claudication Questionnaire (ZCQ symptom severity (ss, physical function (pf, and patient satisfaction (ps subdomains, leg and back pain visual analog scale (VAS, and Oswestry Disability Index (ODI.Results: At 5 years, 84% of patients (74 of 88 demonstrated clinical success on at least two of three ZCQ domains. Individual ZCQ domain success rates were 75% (66 of 88, 81% (71 of 88, and 90% (79 of 88 for ZCQss, ZCQpf, and ZCQps, respectively. Leg and back pain success rates were 80% (68 of 85 and 65% (55 of 85, respectively, and the success rate for ODI was 65% (57 of 88. Percentage improvements over baseline were 42%, 39%, 75%, 66%, and 58% for ZCQss, ZCQpf, leg and back pain VAS, and ODI, respectively (all P<0.001. Within-group effect sizes were classified as very large for four of five clinical outcomes (ie, >1.0; all P<0.0001. Seventy-five percent of IPD patients were free from reoperation, revision, or supplemental fixation at their index level at 5 years.Conclusion: After 5 years of follow-up, IPD with a stand-alone spacer provides

  2. Ten year results of a randomised trial comparing two conservative treatment strategies for small size breast cancer

    International Nuclear Information System (INIS)

    Mariani, L.; Salvadori, B.; Marubini, E.; Conti, A.R.; Rovini, D.; Cusumano, F.; Rosolin, T.; Andreola, S.; Zucali, R.; Rilke, F.; Veronesi, U.

    1998-01-01

    We report the 10-year results of a randomised clinical trial in which two different breast conservation treatment strategies were compared in women with small, non-metastatic primary breast cancer: quadrantectomy, axillary dissection and radiotherapy (QUART) versus tumorectomy and axillary dissection followed by external radiotherapy and a boost with 192 Ir implantation (TART). No second surgery was given to women with affected surgical margins. Axillary node positive women received adjuvant medical therapy. From 1985-1987, this trial accrued 705 patients, 360 in the QUART and 345 in the TART arm. Crude cumulative incidence curves for intrabreast tumour recurrence (IBTR) and metastases as first events and mortality curves in each of the two treatment arms were computed. A crude cumulative incidence curve of IBTR as a second event (in women who had already had a local recurrence) was also computed. The two groups were compared in terms of hazard for IBTR, metastases or death occurrence by using Cox regression models, both with and without adjustment for patient age, tumour size, number of metastatic axillary nodes and histology. Possible interactions between the aforementioned prognostic factors and the type of surgery were also investigated. The two groups were well matched for baseline patient and tumour characteristics, the only exception being resection margins, which were more often positive in the TART group. At the Cox model, a significant difference between groups was detected for IBTR (P<0.0001), but not for distant metastases and overall survival. In particular, 5- and 10-year estimates of crude cumulative incidence of IBTR were 4.7 and 7.4% in the QUART group, and 11.6 and 18.6% in the TART group. The difference was not substantially affected by patient or disease characteristics. Likewise, the status of resection margins in women who underwent TART treatment did not significantly influence the risk of occurrence of IBTRs. Finally, the rate of second IBTR

  3. Six-year positive effects of a mindfulness-based intervention on mindfulness, coping and well-being in medical and psychology students; Results from a randomized controlled trial

    Science.gov (United States)

    Rosenvinge, Jan H.; Tyssen, Reidar; Hanley, Adam; Garland, Eric

    2018-01-01

    Longitudinal research investigating the enduring impact of mindfulness training is scarce. This study investigates the six-year effects of a seven-week mindfulness-based course, by studying intervention effects in the trajectory of dispositional mindfulness and coping skills, and the association between those change trajectories and subjective well-being at six-year follow-up. 288 Norwegian medical and psychology students participated in a randomized controlled trial. 144 received a 15-hour mindfulness course over seven weeks in the second or third semester with booster sessions twice yearly, while the rest continued their normal study curricula. Outcomes were subjective well-being, and dispositional mindfulness and coping assessed using the Five Facet Mindfulness Questionnaire and the Ways of Coping Checklist. Analyses were performed for the intention-to-treat sample, using latent growth curve models. At six-year follow-up, students receiving mindfulness training reported increased well-being. Furthermore, they reported greater increases in the trajectory of dispositional mindfulness and problem-focused coping along with greater decreases in the trajectory of avoidance-focused coping. Increases in problem-focused coping predicted increases in well-being. These effects were found despite relatively low levels of adherence to formal mindfulness practice. The findings demonstrate the viability of mindfulness training in the promotion of well-being and adaptive coping, which could contribute to the quality of care given, and to the resilience and persistence of health care professionals. Trial registration: Clinicaltrials.gov NCT00892138 PMID:29689081

  4. Glaucoma-related adverse events in the first five years after unilateral cataract removal in the Infant Aphakia Treatment Study

    Science.gov (United States)

    Freedman, Sharon F.; Lynn, Michael J.; Beck, Allen D.; Bothun, Erick D.; Orge, Faruk H.; Lambert, Scott R.

    2015-01-01

    Importance Glaucoma-related adverse events constitute major sight-threatening complications of cataract removal in infancy, yet their relationship to aphakia versus primary intraocular lens (IOL) implantation remains unsettled. Objective To identify and characterize cases of glaucoma and glaucoma-related adverse events (glaucoma+glaucoma suspect) among children in the Infant Aphakia Treatment Study (IATS) by the age of five years. Design, Setting, and Participants A multicenter randomized controlled trial of 114 infants with unilateral congenital cataract who were between age 1–6 months at surgery. Interventions Participants were randomized at cataract surgery to either primary IOL, or no IOL implantation (contact lens [CL]). Standardized definitions of glaucoma and glaucoma suspect were created for IATS and applied for surveillance and diagnosis. Main Outcome Measures Development of glaucoma and glaucoma+glaucoma suspect in operated eyes up to age five years, plus intraocular pressure, visual acuity, and axial length at age five years. Results Product limit estimates of the risk of glaucoma and glaucoma+glaucoma suspect at 4.8 years after surgery were 17% (95%CI=11%–25%) and 31% (95%CI=24%–41%), respectively. The CL and IOL groups were not significantly different for either outcome: glaucoma (hazard ratio(HR)=0.8[95%CI=0.3–2.0],p=0.62); glaucoma+glaucoma suspect: (HR=1.3[95%CI=0.6–2.5],p=0.58). Younger (versus older) age at surgery conferred increased risk of glaucoma (26% versus 9%, respectively at 4.8 years after surgery (HR=3.2[95%CI=1.2–8.3]), and smaller (versus larger) corneal diameter showed increased risk for glaucoma+glaucoma suspect (HR=2.5[95%CI=1.3–5.0]). Age and corneal diameter were significantly positively correlated. Glaucoma was predominantly open angle (19/20 cases, 95%), most eyes received medication (19/20, 95%), and 8/20 (40%) eyes had surgery. Conclusions and Relevance These results suggest that glaucoma-related adverse events

  5. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials

    NARCIS (Netherlands)

    Goyal, Mayank; Menon, Bijoy K.; van Zwam, Wim H.; Dippel, Diederik W. J.; Mitchell, Peter J.; Demchuk, Andrew M.; Dávalos, Antoni; Majoie, Charles B. L. M.; van der Lugt, Aad; de Miquel, Maria A.; Donnan, Geoffrey A.; Roos, Yvo B. W. E. M.; Bonafe, Alain; Jahan, Reza; Diener, Hans-Christoph; van den Berg, Lucie A.; Levy, Elad I.; Berkhemer, Olvert A.; Pereira, Vitor M.; Rempel, Jeremy; Millán, Mònica; Davis, Stephen M.; Roy, Daniel; Thornton, John; Román, Luis San; Ribó, Marc; Beumer, Debbie; Stouch, Bruce; Brown, Scott; Campbell, Bruce C. V.; van Oostenbrugge, Robert J.; Saver, Jeffrey L.; Hill, Michael D.; Jovin, Tudor G.

    2016-01-01

    In 2015, five randomised trials showed efficacy of endovascular thrombectomy over standard medical care in patients with acute ischaemic stroke caused by occlusion of arteries of the proximal anterior circulation. In this meta-analysis we, the trial investigators, aimed to pool individual patient

  6. Five-year Treatment Outcomes in the Ahmed Baerveldt Comparison Study

    Science.gov (United States)

    Budenz, Donald L.; Barton, Keith; Gedde, Steven J.; Feuer, William J.; Schiffman, Joyce; Costa, Vital P.; Godfrey, David G.; Buys, Yvonne M.

    2014-01-01

    Purpose To compare the five year outcomes of the Ahmed FP7 Glaucoma Valve (AGV) and the Baerveldt 101-350 Glaucoma Implant (BGI) for the treatment of refractory glaucoma. Design Multicenter randomized controlled clinical trial. Participants 276 patients, including 143 in the AGV group and 133 in the BGI group. Methods Patients 18 to 85 years of age with previous intraocular surgery or refractory glaucoma and intraocular pressure (IOP) of ≥ 18 mmHg in whom glaucoma drainage implant surgery was planned were randomized to implantation of either an AGV or BGI. Main Outcome Measures IOP, visual acuity, use of glaucoma medications, complications, and failure (IOP > 21 mmHg or not reduced by 20% from baseline, IOP ≤ 5 mmHg, reoperation for glaucoma, removal of implant, or loss of light perception). Results At 5 years, IOP (mean ± SD) was 14.7 ± 4.4 mmHg in the AGV group and 12.7 ± 4.5 mmHg in the BGI group (p = 0.012). The number of glaucoma medications in use at 5 years (mean ± SD) was 2.2 ± 1.4 in the AGV group and 1.8 ± 1.5 in the BGI group (p = 0.28). The cumulative probability of failure during 5 years of follow-up was 44.7% in the AGV group and 39.4% in the BGI group (p = 0.65). The number of subjects failing due to inadequately controlled IOP or reoperation for glaucoma was 46 in the AGV group (80% of AGV failures) and 25 in the BGI group (53% of BGI failures, p=0.003). Eleven AGV eyes (20% of AGV failures) experienced persistent hypotony, explantation of implant, or loss of light perception compared to 22 (47% of failures) in the BGI group. The 5-year cumulative reoperation rate for glaucoma was 20.8% in the AGV group compared to 8.6% in the BGI group (p=0.010). Change in logMAR Snellen visual acuity (mean ± SD) at 5 years was 0.42 ± 0.99 in the AGV group and 0.43 ± 0.84 in the BGI group (p=0.97). Conclusions Similar rates of surgical success were observed with both implants at 5 years. BGI implantation produced greater IOP reduction and a lower rate

  7. What do Americans think about federal tax options to support public transit, highways, and local streets and roads? Results from year five of a national survey.

    Science.gov (United States)

    2014-06-01

    This report summarizes the results of year five of a national random-digit-dial public opinion poll asking 1,503 respondents if they : would support various tax options for raising federal transportation revenues, with a special focus on understandin...

  8. Results from the 5-year SQ grass sublingual immunotherapy tablet asthma prevention (GAP) trial in children with grass pollen allergy.

    Science.gov (United States)

    Valovirta, Erkka; Petersen, Thomas H; Piotrowska, Teresa; Laursen, Mette K; Andersen, Jens S; Sørensen, Helle F; Klink, Rabih

    2018-02-01

    Allergy immunotherapy targets the immunological cause of allergic rhinoconjunctivitis and allergic asthma and has the potential to alter the natural course of allergic disease. The primary objective was to investigate the effect of the SQ grass sublingual immunotherapy tablet compared with placebo on the risk of developing asthma. A total of 812 children (5-12 years), with a clinically relevant history of grass pollen allergic rhinoconjunctivitis and no medical history or signs of asthma, were included in the randomized, double-blind, placebo-controlled trial, comprising 3 years of treatment and 2 years of follow-up. There was no difference in time to onset of asthma, defined by prespecified asthma criteria relying on documented reversible impairment of lung function (primary endpoint). Treatment with the SQ grass sublingual immunotherapy tablet significantly reduced the risk of experiencing asthma symptoms or using asthma medication at the end of trial (odds ratio = 0.66, P year posttreatment follow-up, and during the entire 5-year trial period. Also, grass allergic rhinoconjunctivitis symptoms were 22% to 30% reduced (P years). At the end of the trial, the use of allergic rhinoconjunctivitis pharmacotherapy was significantly less (27% relative difference to placebo, P < .001). Total IgE, grass pollen-specific IgE, and skin prick test reactivity to grass pollen were all reduced compared to placebo. Treatment with the SQ grass sublingual immunotherapy tablet reduced the risk of experiencing asthma symptoms and using asthma medication, and had a positive, long-term clinical effect on rhinoconjunctivitis symptoms and medication use but did not show an effect on the time to onset of asthma. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  9. Risk Factors for Malnutrition Among Under-Five-Year olds in an ...

    African Journals Online (AJOL)

    Objectives: To identify risk factors associated with the development of malnutrition in the under-five-year olds in a homogeneous inner city community. Design: A community-based, case-control study. Materials and Methods: One hundred and thirty eight children (subjects and controls) aged less than five years living in the ...

  10. An appraisal of retained placentae in Ibadan: a five year review ...

    African Journals Online (AJOL)

    During the study period, 4980 deliveries took place at the University College Hospital, Ibadan and 106 cases of retained placenta were managed making the incidence 2.13 per cent of all births. Results: During the five year period, there were 106 patients with retained placenta; of these, 90 (84.9%) case notes were ...

  11. Bon courage! (Five-Yearly Review)

    CERN Multimedia

    Association du personnel

    2006-01-01

    With these words of encouragement the Director General ended his long presentation to the staff on 12 January. And he is not wrong there…we certainly will need courage, not only to complete the LHC and other CERN projects, but also, unfortunately, to defend our employment conditions. Indeed, Mr. Aymar very (too) quickly presented us with his conclusions on the Five-Yearly Review, in a resolutely positive manner. In short, we can say that, beneath a deceptive exterior, a serious attack on our employment conditions is in preparation! Salary levels, careers, family…we are talking about your future! Last June, a huge majority of you approved the Staff Association's demands for this Review.

  12. Lenin nuclear reactor research institute in the tenth five-year plan

    International Nuclear Information System (INIS)

    Tsykanov, V.A.; Kulov, E.V.

    1980-01-01

    Main tasks and research results of Lenin Nuclear Reactor Reseach Institute in the 10-th Five-Year Plan are considered. Main research achievements are noted in nuclear power, radiation material testing, accumulation of transuranium elements and investigation of their physicochemical properties at VK-50, BOR-60, SM-2, RBT-6 and MIR reactor plants and in material testing laboratories

  13. Safety of Seasonal Malaria Chemoprevention (SMC with Sulfadoxine-Pyrimethamine plus Amodiaquine when Delivered to Children under 10 Years of Age by District Health Services in Senegal: Results from a Stepped-Wedge Cluster Randomized Trial.

    Directory of Open Access Journals (Sweden)

    J L NDiaye

    Full Text Available It is recommended that children aged 3 months to five years of age living in areas of seasonal transmission in the sub-Sahel should receive Seasonal Malaria Chemoprevention (SMC with sulfadoxine-pyrimethamine plus amodiaquine (SPAQ during the malaria transmission season. The purpose of this study was to evaluate the safety of SMC with SPAQ in children when delivered by community health workers in three districts in Senegal where SMC was introduced over three years, in children from 3 months of age to five years of age in the first year, then in children up to 10 years of age.A surveillance system was established to record all deaths and all malaria cases diagnosed at health facilities and a pharmacovigilance system was established to detect adverse drug reactions. Health posts were randomized to introduce SMC in a stepped wedge design. SMC with SPAQ was administered once per month from September to November, by nine health-posts in 2008, by 27 in 2009 and by 45 in 2010.After three years, 780,000 documented courses of SMC had been administered. High coverage was achieved. No serious adverse events attributable to the intervention were detected, despite a high level of surveillance.SMC is being implemented in countries of the sub-Sahel for children under 5 years of age, but in some areas the age distribution of cases of malaria may justify extending this age limit, as has been done in Senegal. Our results show that SMC is well tolerated in children under five and in older children. However, pharmacovigilance should be maintained where SMC is implemented and provision for strengthening national pharmacovigilance systems should be included in plans for SMC implementation.ClinicalTrials.gov NCT 00712374.

  14. Gender difference on five-year outcomes of EXCEL biodegradable polymer-coated sirolimus-eluting stents implantation: results from the CREATE study.

    Science.gov (United States)

    Zhang, Lei; Qiao, Bing; Han, Ya-Ling; Li, Yi; Xu, Kai; Zhang, Quan-Yu; Yang, Li-Xia; Liu, Hui-Liang; Xu, Bo; Gao, Run-Lin

    2013-03-01

    The gender difference on long-term outcome in unselected patients after percutaneous coronary intervention (PCI) has not yet been fully investigated. This study aimed to evaluate the gender difference on five-year outcomes following EXCEL biodegradable polymer-coated sirolimus-eluting stenting in patients with coronary disease. A total of 2077 "all comers", consisting of 1528 (73.6%) men and 549 (26.4%) women, who were exclusively treated with EXCEL coronary stents were enrolled in the prospective CREATE study at 59 centers from four countries. After propensity score matching, the baseline characteristics of the two groups were well matched. Recommended antiplatelet regimen was clopidogrel and aspirin for six months followed by chronic aspirin therapy. The primary outcome that was the rate of major adverse cardiac events (MACE), defined as a composite of cardiac mortality, non-fatal myocardial infarction (MI) and target lesion revascularization (TLR), and stent thrombosis (ST) at five years were compared between the two gender groups. In the two groups, women had higher proportions of clinical risk factors, such as being elderly, diabetes mellitus, hypertension and hyperlipidemia, compared to men. Besides, the mean target vessel number per patient was higher and the mean reference vessel diameter smaller for women. Men had higher risks of cardiac death (3.7% vs. 1.6%, P = 0.021) and MACE (8.4% vs. 4.7%, P = 0.004) at five years compared with women. However, the cumulative hazards of non-fatal MI and TLR were similar between men and women. The incidence of Academic Research Consortium (ARC) definite or probable stent thrombosis was similar between the two groups (1.3% vs. 1.0%, P = 0.639). Prolonged clopidogrel therapy (>6 months) did not reduce the cumulative hazards of ST from six months to five years in both men (χ(2) = 0.098, log rank P = 0.754) and women (χ(2) = 2.043, log rank P = 0.153) patients. Women had a lower MACE and cardiac death rate than men after

  15. Retrospective evaluation of the five-year and ten-year CSEP-Italy earthquake forecasts

    Directory of Open Access Journals (Sweden)

    Stefan Wiemer

    2010-11-01

    Full Text Available On August 1, 2009, the global Collaboratory for the Study of Earthquake Predictability (CSEP launched a prospective and comparative earthquake predictability experiment in Italy. The goal of this CSEP-Italy experiment is to test earthquake occurrence hypotheses that have been formalized as probabilistic earthquake forecasts over temporal scales that range from days to years. In the first round of forecast submissions, members of the CSEP-Italy Working Group presented 18 five-year and ten-year earthquake forecasts to the European CSEP Testing Center at ETH Zurich. We have considered here the twelve time-independent earthquake forecasts among this set, and evaluated them with respect to past seismicity data from two Italian earthquake catalogs. We present the results of the tests that measure the consistencies of the forecasts according to past observations. As well as being an evaluation of the time-independent forecasts submitted, this exercise provides insight into a number of important issues in predictability experiments with regard to the specification of the forecasts, the performance of the tests, and the trade-off between robustness of results and experiment duration. We conclude with suggestions for the design of future earthquake predictability experiments.

  16. Radiation curing - twenty five years on

    International Nuclear Information System (INIS)

    Garnett, J.L.

    1995-01-01

    Progress in UV/EB curing during the past twenty five years is briefly reviewed. During this time developments in unique polymer chemistry, novel equipment design and the introduction of relevant educational programmes has enabled radiation curing to become an established technology with specific strengths in certain industries. Possible reasons for the emergence of the technology in these niche markets are discussed. Despite the worldwide recession, radiation curing is shown to be expanding at 5% per annum with the prospect of higher growth with improving economic conditions. (Author)

  17. Higher morale is associated with lower risk of depressive disorders five years later among very old people.

    Science.gov (United States)

    Niklasson, Johan; Näsman, Marina; Nyqvist, Fredrica; Conradsson, Mia; Olofsson, Birgitta; Lövheim, Hugo; Gustafson, Yngve

    The aim of this study was to investigate whether higher morale, i.e. future-oriented optimism, at baseline was associated with lower risk of depressive disorders five years later among very old people.Methods The Umeå85+/GErontological Regional Database, a population-based study with a longitudinal design, recruited participants in Sweden and Finland aged 85, 90 and ≥95 years. The sample in the present study included 647 individuals (89.1±4.4 years (Mean±SD), range 85-103). After five years, 216 were alive and agreed to a follow-up (92.6±3.4 years, range 90-104). The Philadelphia Geriatric Center Morale Scale (PGCMS) was used to assess morale. The depressive disorder diagnosis was determined according to DSM-IV based on medical records and interview data including assessment scales for depressive disorders. A number of sociodemographic, functional and health-related variables were analysed as possible confounders.Results For those with no depressive disorders at baseline, the only baseline variable significantly associated with depressive disorders five years later was the PGCMS score. A logistic regression model showed lower risk of depressive disorders five years later with higher baseline PGCMS scores (odds ratio 0.779 for one point increase in PGCMS, pfive years later).Conclusion Our results indicate that the higher the morale, the lower the risk of depressive disorders five years later among very old people. The PGCMS seems to identify those very old individuals at increased risk of depressive disorders five years later. Preventive measures could befocused on this group. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  18. Five-Yearly Review: TREF avoids the worst!

    CERN Multimedia

    Staff Association

    2006-01-01

    In our last edition, we informed you about the Staff Council decision to reject the entire set of proposals for the five-yearly review, on the basis of the Director-General's revised proposals 2 and 10. We also indicated that a total failure could still be avoided at TREF on 4 and 5 October. To our relief, TREF avoided the worst!

  19. Breast sarcoma surgical management: a five-year multicentric study

    Directory of Open Access Journals (Sweden)

    Răzvan V. Scăunașu

    2016-11-01

    Full Text Available Background. Breast sarcomas are a heterogeneous group of breast neoplasms with a low incidence and a reserved prognosis. No treatment protocol has been yet established, a guideline similar to soft tissue sarcomas is used. Materials and Methods. Our study analyzed all the patients admitted with the diagnosis of malignant breast disease in two specialized centers on a five-year time frame. We compared long term results for the patients who underwent conservative treatment and mastectomy. Results. A total of 76 cases received surgical treatment with curative intent, 24 conservative procedures and 52 mastectomies. Incidence of local recurrence does not appear to be closely related to the type of surgical procedure. There were a number of five local recurrences for patients who received conservative treatment and 7 local recurrences where we used mastectomy. Kaplan-Meier analysis conducted shows no differences statistically significant (sig = 0.459 between the results of conservative treatment and mastectomy. Basically conservative surgery seems to get similar results, provided that R0 resection objective can be met. Conclusions. Treatment options are more limited for breast sarcomas than carcinomas, the role of surgery being more important to therapeutic success. The biological characteristic of the tumor including histological type and sub-type, play an important role in determining the results and the treatment should be tailored and adapted for each case.

  20. Five-Year NRHP Re-Evaluation of Historic Buildings Assessment

    Energy Technology Data Exchange (ETDEWEB)

    Ullrich, R A; Heidecker, K R

    2011-09-12

    The Lawrence Livermore National Laboratory (LLNL) 'Draft Programmatic Agreement among the Department of Energy and the California State Historic Preservation Officer Regarding Operation of Lawrence Livermore National Laboratory' requires a review and re-evaluation of the eligibility of laboratory properties for the National Register of Historic Places (NRHP) every five years. The original evaluation was published in 2005; this report serves as the first five-year re-evaluation. This re-evaluation includes consideration of changes within LLNL to management, to mission, and to the built environment. it also determines the status of those buildings, objects, and districts that were recommended as NRHP-eligible in the 2005 report. Buildings that were omitted from the earlier building list, those that have reached 50 years of age since the original assessment, and new buildings are also addressed in the re-evaluation.

  1. Linking ClinicalTrials.gov and PubMed to track results of interventional human clinical trials.

    Directory of Open Access Journals (Sweden)

    Vojtech Huser

    Full Text Available OBJECTIVE: In an effort to understand how results of human clinical trials are made public, we analyze a large set of clinical trials registered at ClinicalTrials.gov, the world's largest clinical trial registry. MATERIALS AND METHODS: We considered two trial result artifacts: (1 existence of a trial result journal article that is formally linked to a registered trial or (2 the deposition of a trial's basic summary results within the registry. RESULTS: The study sample consisted of 8907 completed, interventional, phase 2-or-higher clinical trials that were completed in 2006-2009. The majority of trials (72.2% had no structured trial-article link present. A total of 2367 trials (26.6% deposited basic summary results within the registry. Of those, 969 trials (10.9% were classified as trials with extended results and 1398 trials (15.7% were classified as trials with only required basic results. The majority of the trials (54.8% had no evidence of results, based on either linked result articles or basic summary results (silent trials, while a minimal number (9.2% report results through both registry deposition and publication. DISCUSSION: Our study analyzes the body of linked knowledge around clinical trials (which we refer to as the "trialome". Our results show that most trials do not report results and, for those that do, there is minimal overlap in the types of reporting. We identify several mechanisms by which the linkages between trials and their published results can be increased. CONCLUSION: Our study shows that even when combining publications and registry results, and despite availability of several information channels, trial sponsors do not sufficiently meet the mandate to inform the public either via a linked result publication or basic results submission.

  2. Infant wellbeing at 2 years of age in the Growth Restriction Intervention Trial (GRIT): multicentred randomised controlled trial.

    Science.gov (United States)

    Thornton, J G; Hornbuckle, J; Vail, A; Spiegelhalter, D J; Levene, M

    Although delivery is widely used for preterm babies failing to thrive in utero, the effect of altering delivery timing has never been assessed in a randomised controlled trial. We aimed to compare the effect of delivering early with delaying birth for as long as possible. 548 pregnant women were recruited by 69 hospitals in 13 European countries. Participants had fetal compromise between 24 and 36 weeks, an umbilical-artery doppler waveform recorded, and clinical uncertainty about whether immediate delivery was indicated. Before birth, 588 babies were randomly assigned to immediate delivery (n=296) or delayed delivery until the obstetrician was no longer uncertain (n=292). The main outcome was death or disability at or beyond 2 years of age. Disability was defined as a Griffiths developmental quotient of 70 or less or the presence of motor or perceptual severe disability. Analysis was by intention-to-treat. This trial has been assigned the International Standard Randomised Controlled Trial Number ISRCTN41358726. Primary outcomes were available on 290 (98%) immediate and 283 (97%) deferred deliveries. Overall rate of death or severe disability at 2 years was 55 (19%) of 290 immediate births, and 44 (16%) of 283 delayed births. With adjustment for gestational age and umbilical-artery doppler category, the odds ratio (95% CrI) was 1.1 (0.7-1.8). Most of the observed difference was in disability in babies younger than 31 weeks of gestation at randomisation: 14 (13%) immediate versus five (5%) delayed deliveries. No important differences in the median Griffiths developmental quotient in survivors was seen. The lack of difference in mortality suggests that obstetricians are delivering sick preterm babies at about the correct moment to minimise mortality. However, they could be delivering too early to minimise brain damage. These results do not lend support to the idea that obstetricians can deliver before terminal hypoxaemia to improve brain development.

  3. Results from the 5-year SQ grass sublingual immunotherapy tablet asthma prevention (GAP) trial in children with grass pollen allergy

    DEFF Research Database (Denmark)

    Valovirta, Erkka; Petersen, Thomas H; Piotrowska, Teresa

    2018-01-01

    BACKGROUND: Allergy immunotherapy targets the immunological cause of allergic rhinoconjunctivitis and allergic asthma and has the potential to alter the natural course of allergic disease. OBJECTIVE: The primary objective was to investigate the effect of the SQ grass sublingual immunotherapy tablet...... compared with placebo on the risk of developing asthma. METHODS: A total of 812 children (5-12 years), with a clinically relevant history of grass pollen allergic rhinoconjunctivitis and no medical history or signs of asthma, were included in the randomized, double-blind, placebo-controlled trial......, comprising 3 years of treatment and 2 years of follow-up. RESULTS: There was no difference in time to onset of asthma, defined by prespecified asthma criteria relying on documented reversible impairment of lung function (primary endpoint). Treatment with the SQ grass sublingual immunotherapy tablet...

  4. Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Arthur V Peterson

    Full Text Available The Hutchinson Study of High School Smoking was the first randomized trial to show effectiveness of a smoking cessation intervention on 6-months prolonged smoking abstinence at one year post-intervention in a large population-based sample of adolescent smokers. An important question remains: Do the positive effects from teen smoking cessation interventions seen at up to 12 months post-intervention endure into young adulthood? This study examines for the first time whether such positive early effects from teen smoking cessation intervention can endure into young adulthood in the absence of additional intervention.High school smokers (n = 2,151 were proactively recruited into the trial from fifty randomly selected Washington State high schools randomized to the experimental (Motivational Interviewing + Cognitive Behavioral Skills Training telephone counseling intervention or control (no intervention condition. These smokers were followed to 7 years post high school to ascertain rates of six-year prolonged smoking abstinence in young adulthood. All statistical tests are two-sided.No evidence of intervention impact at seven years post high school was observed for the main endpoint of six-year prolonged abstinence, neither among all smokers (14.2% in the experimental condition vs. 13.1% in the control condition, difference = +1.1%, 95% confidence interval (CI = -3.4 to 5.8, p = .61, nor among the subgroups of daily smokers and less-than-daily smokers, nor among other a priori subgroups. But, observed among males was some evidence of an intervention impact on two endpoints related to progress towards quitting: reduction in number of days smoked in the past month, and increase in the length of the longest quit attempt in the past year.There was no evidence from this trial among adolescent smokers that positive effectiveness of the proactive telephone intervention for smoking abstinence, observed previously at one year post-intervention, was sustained

  5. Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial.

    Science.gov (United States)

    Peterson, Arthur V; Marek, Patrick M; Kealey, Kathleen A; Bricker, Jonathan B; Ludman, Evette J; Heffner, Jaimee L

    2016-01-01

    The Hutchinson Study of High School Smoking was the first randomized trial to show effectiveness of a smoking cessation intervention on 6-months prolonged smoking abstinence at one year post-intervention in a large population-based sample of adolescent smokers. An important question remains: Do the positive effects from teen smoking cessation interventions seen at up to 12 months post-intervention endure into young adulthood? This study examines for the first time whether such positive early effects from teen smoking cessation intervention can endure into young adulthood in the absence of additional intervention. High school smokers (n = 2,151) were proactively recruited into the trial from fifty randomly selected Washington State high schools randomized to the experimental (Motivational Interviewing + Cognitive Behavioral Skills Training telephone counseling intervention) or control (no intervention) condition. These smokers were followed to 7 years post high school to ascertain rates of six-year prolonged smoking abstinence in young adulthood. All statistical tests are two-sided. No evidence of intervention impact at seven years post high school was observed for the main endpoint of six-year prolonged abstinence, neither among all smokers (14.2% in the experimental condition vs. 13.1% in the control condition, difference = +1.1%, 95% confidence interval (CI) = -3.4 to 5.8, p = .61), nor among the subgroups of daily smokers and less-than-daily smokers, nor among other a priori subgroups. But, observed among males was some evidence of an intervention impact on two endpoints related to progress towards quitting: reduction in number of days smoked in the past month, and increase in the length of the longest quit attempt in the past year. There was no evidence from this trial among adolescent smokers that positive effectiveness of the proactive telephone intervention for smoking abstinence, observed previously at one year post-intervention, was sustained for the long

  6. Risk Factors of Diarrhea in Children Under Five Years in Urban Slums

    Directory of Open Access Journals (Sweden)

    Balakrishna Kalakheti

    2016-12-01

    Full Text Available Introduction: Diarrhea is a leading cause of mortality in children in developing countries and the condition is worse in slums. In order to provide effective preventive and management strategies, it is important to identify factors associated with the disease. This study was carried out to investigate the risk factors of diarrhea in  children under five years of age in urban slums. Methods: Parents of all children under five years from the urban slums of Tansen municipality, Palpa, Nepal were interviewed using a standardized pretested questionnaire and proforma. Parental variables, environmental factors, and presence of diarrhea in those children in past three months were collected by trained enumerators and the data were analyzed with statistical software SPSS-10. Results: A total of 450 under five years children were enrolled in the study. There were 216 (48% male and 234 (52% female children with F:M ratio of 1.08:1. Occurrence of diarrhea was lower if the children were breast-fed for more than six months, well-nourished, used fountain water for drinking, or used boiled or treated water. Similarly, diarrhea prevalence was lower if father had a regular job, daily income in the family was more than one US dollar, there was a toilet in the house, practice of hand washing was followed before feeding or preparing food, or there was no child suffering from diarrhea in the neighborhood. Conclusion: There are a few variables that are significantly related to diarrhea in children under five years of age. In order to decrease the diarrheal episodes in children in the slums of the developing countries, priority could be given in the improvement of those variables.

  7. Evaluating the financial impact of clinical trials in oncology: results from a pilot study from the Association of American Cancer Institutes/Northwestern University clinical trials costs and charges project.

    Science.gov (United States)

    Bennett, C L; Stinson, T J; Vogel, V; Robertson, L; Leedy, D; O'Brien, P; Hobbs, J; Sutton, T; Ruckdeschel, J C; Chirikos, T N; Weiner, R S; Ramsey, M M; Wicha, M S

    2000-08-01

    Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials. Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer. The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P =.4) Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning

  8. 75 FR 75453 - Proposed Information Collection; Comment Request; Five-Year Records Retention Requirement for...

    Science.gov (United States)

    2010-12-03

    ... Request; Five-Year Records Retention Requirement for Export Transactions and Boycott Actions AGENCY... parties involved in export transactions and the U.S. party involved in a boycott action are required to... boycott documents and reports. The five-year record retention period corresponds with the five-year...

  9. Does low-constraint mobile bearing knee prosthesis give satisfactory results for severe coronal deformities? A five to twelve year follow up study.

    Science.gov (United States)

    Czekaj, Jaroslaw; Fary, Camdon; Gaillard, Thierry; Lustig, Sebastien

    2017-07-01

    Severe varus and valgus knee deformities traditionally are replaced with constrained implants, with a number of disadvantages. We present our results in this challenging group using a low constraint deep-dish mobile bearing implant design. One hundred fifty-four patients (170 arthroplasties) who underwent primary TKA using a deep-dish, mobile bearing posterior-stabilized implant for severe varus (HKA  190°) deformity between 2004 and 2009 were evaluated at a mean of 6.6 years post-operatively (minimum of 5 years). Alignment improved from a pre-operative mean (±SD) varus deformity of 167.4° (±2.6°) and a mean (±SD) valgus deformity of 194.1° (±4.0°) to an overall mean (±SD) post-operative mechanical alignment of 178.6° (±3.2°). Twenty-three patients had post-operative varus alignment, five patients had post-operative valgus alignment and 134 knees were in neutral alignment (within 3° spread). Clinical scores at final follow-up were excellent (IKS score 93.8 (±7.4) and function score 82.4 (±20.2)). Three patients were re-operated upon: one deep infection, one periprosthetic fracture and one revision at 144 months for aseptic loosening of the femoral component. No patient was revised for instability or implant failure. The survival rate at five years was 99.4% and at ten years 98.6%. Satisfactory outcomes can be achieved in patients with substantial varus or valgus deformities using low constraint deep-dish mobile bearing implant, standard approach and appropriate soft tissue releases.

  10. Orbital atherectomy system in treating calcified coronary lesions: 3-Year follow-up in first human use study (ORBIT I trial)

    Energy Technology Data Exchange (ETDEWEB)

    Bhatt, Parloop, E-mail: parloop.bhatt@cims.me [Care Institute of Medical Sciences (CIMS), Ahmedabad 380060, Gujarat (India); Parikh, Parth, E-mail: parth.parikh@cimshospital.org [Care Institute of Medical Sciences (CIMS), Ahmedabad 380060, Gujarat (India); Patel, Apurva, E-mail: patela12@ccf.org [Internal Medicine, Cleveland Clinic Foundation, Cleveland, OH (United States); Chag, Milan, E-mail: milan.chag@cims.me [Care Institute of Medical Sciences (CIMS), Ahmedabad 380060, Gujarat (India); Chandarana, Anish, E-mail: anish.chandarana@cims.me [Care Institute of Medical Sciences (CIMS), Ahmedabad 380060, Gujarat (India); Parikh, Roosha, E-mail: parikhr@ccf.org [Internal Medicine, Cleveland Clinic Foundation, Cleveland, OH (United States); Parikh, Keyur, E-mail: keyur.parikh@cims.me [Care Institute of Medical Sciences (CIMS), Ahmedabad 380060, Gujarat (India)

    2014-06-15

    Background/Purpose: The ORBIT I trial evaluated the safety and performance of an orbital atherectomy system (OAS) in treating de novo calcified coronary lesions. Severely calcified coronary arteries pose ongoing treatment challenges. Stent placement in calcified lesions can result in stent under expansion, malapposition and procedural complications. OAS treatment may be recommended to facilitate coronary stent implantation in these difficult lesions. Materials/Methods: Fifty patients with de novo calcified coronary lesions were enrolled in the ORBIT I trial. Patients were treated with the OAS followed by stent placement. Our institution treated 33/50 patients and continued follow-up for 3 years. Results: Average age was 54.4 years and 90.9% were males. Mean lesion length was 15.9 mm. The average number of OAS devices used per patient was 1.3. Procedural success was achieved in 97% of patients. Angiographic complications were observed in five patients (two minor dissections, one major dissection and two perforations). The cumulative major adverse cardiac event (MACE) rate was 6.1% in-hospital, 9.1% at 30 days, 12.1% at 6 months, 15.2% at 2 years, and 18.2% at 3 years. The MACE rate included two in-hospital non Q-wave myocardial infarctions (MI), one additional non Q-wave MI at 30 days leading to target lesion revascularization (TLR), and three cardiac deaths. Conclusions: The ORBIT I trial suggests that OAS treatment may offer an effective method to modify calcified coronary lesion compliance to facilitate optimal stent placement in these difficult-to-treat patients with acceptable levels of safety up to 3 years post-index procedure.

  11. RTOG: Updated results of randomized trials

    International Nuclear Information System (INIS)

    Curran, Walter J.

    1997-01-01

    Objective: To review the background, rationale and available results for recently completed randomized comparative clinical trials of the Radiation Therapy Oncology Group (RTOG), including inter group trials in which the RTOG has been the managing group or a major participant. When available, laboratory studies will be correlated with clinical results

  12. Long-term outcomes five years after selective dorsal rhizotomy

    Directory of Open Access Journals (Sweden)

    Lagergren Jan

    2008-12-01

    Full Text Available Abstract Background Selective dorsal rhizotomy (SDR is a well accepted neurosurgical procedure performed for the relief of spasticity interfering with motor function in children with spastic cerebral palsy (CP. The goal is to improve function, but long-term outcome studies are rare. The aims of this study were to evaluate long-term functional outcomes, safety and side effects during five postoperative years in all children with diplegia undergoing SDR combined with physiotherapy. Methods This study group consisted of 35 children, consecutively operated, with spastic diplegia, of which 26 were Gross Motor Function Classification System (GMFCS levels III–V. Mean age was 4.5 years (range 2.5–6.6. They were all assessed by the same multidisciplinary team at pre- and at 6, 12, 18 months, 3 and 5 years postoperatively. Clinical and demographic data, complications and number of rootlets cut were prospectively registered. Deep tendon reflexes and muscle tone were examined, the latter graded with the modified Ashworth scale. Passive range of motion (PROM was measured with a goniometer. Motor function was classified according to the GMFCS and measured with the Gross Motor Function Measure (GMFM-88 and derived into GMFM-66. Parent's opinions about the children's performance of skills and activities and the amount of caregiver assistance were measured with Pediatric Evaluation Disability Inventory (PEDI. Results The mean proportion of rootlets cut in S2-L2 was 40%. Muscle tone was immediately reduced in adductors, hamstrings and dorsiflexors (p Conclusion SDR is a safe and effective method for reducing spasticity permanently without major negative side effects. In combination with physiotherapy, in a group of carefully selected and systematically followed young children with spastic diplegia, it provides lasting functional benefits over a period of at least five years postoperatively.

  13. Dose escalation with 3D conformal treatment: five year outcomes, treatment optimization, and future directions

    International Nuclear Information System (INIS)

    Hanks, Gerald E.; Hanlon, Alexandra L. M.S.; Schultheiss, Timothy E.; Pinover, Wayne H.; Movsas, Benjamin; Epstein, Barry E.; Hunt, Margie

    1998-01-01

    Purpose: To report the 5-year outcomes of dose escalation with 3D conformal treatment (3DCRT) of prostate cancer. Methods and Materials: Two hundred thirty-two consecutive patients were treated with 3DCRT alone between 6/89 and 10/92 with ICRU reporting point dose that increased from 63 to 79 Gy. The median follow-up was 60 months, and any patient free of clinical or biochemical evidence of disease was termed bNED. Biochemical failure was defined as prostate-specific antigen (PSA) rising on two consecutive recordings and exceeding 1.5 ng/ml. Morbidity was reported by the Radiation Therapy Oncology Group (RTOG) scale, the Late Effects Normal Tissue (LENT) scale, and a Fox Chase modification of the latter (FC-LENT). All patients were treated with a four-field technique with a 1 cm clinical target volume (CTV) to planning target volume (PTV) margin to the prostate or prostate boost; the CTV and gross tumor volume (GTV) were the same. Actuarial rates of outcome were calculated by Kaplan-Meier and cumulative incidence methods and compared using the log rank and Gray's test statistic, respectively. Cox regression models were used to establish prognostic factors predictive of the various measures of outcome. Five-year Kaplan-Meier bNED rates were utilized by dose group to estimate logit response models for bNED and late morbidity. Results: PSA 10 ng/ml based on 5-year bNED results. No dose response was observed for patients with pretreatment PSA 10 ng/ml strongly suggests that clinical trials employing radiation should investigate the use of 3DCRT and prostate doses of 76-80 Gy

  14. Results of a five-year study of 99mTc DMSA renal scintigraphy in children and adolescents following acute pyelonephritis

    International Nuclear Information System (INIS)

    Chroustova, D.; Palyzova, D.; Kolska, M.; Urbanova, I.

    2006-01-01

    Renal scintigraphy, generally using 99' mTc-DMSA, is the accepted reference standard for detection of renal cortical changes. The timing of the test, i.e., whether an acute 99m Tc-DMSA scan, a follow-up only or both scans should be performed, however, remains open to discussion. In our study, a six-month follow- up DMSA scan was performed in all the children diagnosed with a first attack of acute pyelonephritis (APN) in two large paediatric clinics of Charles University's 3 rd School of Medicine in Prague during a five-year period. All diagnoses were confirmed by a paediatric nephrologist. 382 children (267 girls, 115 boys) aged between 7 months and 19 years were included in the study. For analytical purposes, the patients were divided into 4 age groups: I - less than 1 year of age, II - 1-5 years, III - 5-10 years, and IV - 10-19 years. In all children younger than five years, a micturition cystourethrogram (MCUG) for detection of vesicoureteric reflux (VUR) was performed between one and three months after the APN episode. Static renal scintigraphy, using an HR collimator with parallel holes was performed using a planar Gamma camera MB 9200 (Gamma Budapest) in all children six months after APN, with a complement of pinhole images, SPECT or PSPECT of the kidneys. 1. In group I, all four children with positive VUR on MCUG had a pathological DMSA scan, while only two of the 32 patients with negative VUR had a pathological DMSA. 2. In group II, 17 children had VUR on MCUG, six of them with a pathological and 11 with a normal DMSA scan. Most of the 221 children without VUR had a normal DMSA scintigraphy; pathological findings were present in 17 children only. 3. In group III, all children with VUR, but only 5 out of 53 without VUR, had a pathological DMSA scan. 4. Five out of 50 children in group IV had a pathological DMSA. APN occurred most frequently in group II (62.3%, or 238 children) and ranged between 10-15% in the remaining groups. APN was found very frequently

  15. Five years of operating the TRIGA Mainz reactor

    International Nuclear Information System (INIS)

    Benedict, Georg

    1970-01-01

    Considerable obstacles had to be surmounted before TRIGA MAINZ, first TRIGA reactor built in Germany, reached initial criticality in 1965. Subsequent five years' operation did not raise any major problems. The facility has proven quite reliable and particularly well suited for the purposes of the nuclear chemistry research program pursued at Mainz University. Extensive use is made of the pulse mode of operation. As a result, fuel elements are obviously somewhat overstressed, even though most pulses performed are of the 1.50 dollar size. Maximum licensed steady state power of 100 kW till now has met the requirements of most experiments. However, efforts are in progress to improve irradiation conditions by increasing the reactor power to 300 kW. (author)

  16. Publication of noninferiority clinical trials: changes over a 20-year interval.

    Science.gov (United States)

    Suda, Katie J; Hurley, Anne M; McKibbin, Trevor; Motl Moroney, Susannah E

    2011-09-01

    The primary objective was to evaluate the change in publication rate of noninferiority trials over a 20-year interval (1989-2009). Secondary objectives were to analyze the frequency of noninferiority trials by therapeutic category, the frequency of noninferiority trial publication by journal, the impact factors of the publishing journals, any potential special advantages of the study drug over the control, the funding sources of the trials, pharmaceutical industry affiliation of the authors, and the use of ghostwriters in the creation of manuscripts. Retrospective literature review of 583 articles. PubMed (January 1989-December 2009) and EMBASE (first quarter 1989-fourth quarter 2009) databases. A total of 583 articles of the results of randomized controlled clinical trials with a noninferiority study design that evaluated drug therapies, published in English, between 1989 and 2009, were included in the analysis. A consistent increase was noted in their yearly publication rates, with no trials published in 1989 versus 133 in 2009. One hundred twenty-six articles (21.6%) were in the therapeutic category of infectious diseases, followed by 78 (13.4%) in cardiology. Among the journals identified, The New England Journal of Medicine had the highest publication rate of trials with a noninferiority design, with 29 (5.0%) of the identified trials published in this journal. The median impact factor of the journals publishing noninferiority trials was 4.807 (interquartile range 3.064-7.5). The most common advantage of the study drug over the control was reduced duration of treatment or reduced pill burden (80 studies [22.9%]). A total of 425 trials (72.9%) listed the pharmaceutical industry as the only funding source. Among 369 trials with authors employed by the pharmaceutical industry, 101 (17.3%) disclosed an acknowledgment to an individual, other than those listed as authors, who contributed to writing the manuscript and who was affiliated with a medical information

  17. [Association between the use of blood components and the five-year mortality after liver transplant].

    Science.gov (United States)

    de Morais, Bruno Salomé; Sanches, Marcelo Dias; Ribeiro, Daniel Dias; Lima, Agnaldo Soares; de Abreu Ferrari, Teresa Cristina; Duarte, Malvina Maria de Freitas; Cançado, Guilherme Henrique Gomes Moreira

    2011-01-01

    Liver transplant (LT) surgery is associated with significant bleeding in 20% of cases, and several authors have demonstrated the risks related to blood components. The objective of the present study was to evaluate the impact of using blood components during hospitalization in five-year survival of patients undergoing LT. One hundred and thirteen patients were evaluated retrospectively. Several variables, including the use of blood components intraoperatively and throughout hospitalization, were categorized and evaluated by univariate analysis using Fisher's test. A level of significance of 5% was adopted. Results with p renal dysfunction, and longer stay in hospital and ICU are associated with greater five-year mortality after LT (p transplantation (p < 0.01). This study emphasizes the relationship between the use of blood components during hospitalization and increased mortality in five years after LT. 2011 Elsevier Editora Ltda. All rights reserved.

  18. Five-year risk of interval-invasive second breast cancer.

    Science.gov (United States)

    Lee, Janie M; Buist, Diana S M; Houssami, Nehmat; Dowling, Emily C; Halpern, Elkan F; Gazelle, G Scott; Lehman, Constance D; Henderson, Louise M; Hubbard, Rebecca A

    2015-07-01

    Earlier detection of second breast cancers after primary breast cancer (PBC) treatment improves survival, yet mammography is less accurate in women with prior breast cancer. The purpose of this study was to examine women presenting clinically with second breast cancers after negative surveillance mammography (interval cancers), and to estimate the five-year risk of interval-invasive second cancers for women with varying risk profiles. We evaluated a prospective cohort of 15 114 women with 47 717 surveillance mammograms diagnosed with stage 0-II unilateral PBC from 1996 through 2008 at facilities in the Breast Cancer Surveillance Consortium. We used discrete time survival models to estimate the association between odds of an interval-invasive second breast cancer and candidate predictors, including demographic, PBC, and imaging characteristics. All statistical tests were two-sided. The cumulative incidence of second breast cancers after five years was 54.4 per 1000 women, with 325 surveillance-detected and 138 interval-invasive second breast cancers. The five-year risk of interval-invasive second cancer for women with referent category characteristics was 0.60%. For women with the most and least favorable profiles, the five-year risk ranged from 0.07% to 6.11%. Multivariable modeling identified grade II PBC (odds ratio [OR] = 1.95, 95% confidence interval [CI] = 1.15 to 3.31), treatment with lumpectomy without radiation (OR = 3.27, 95% CI = 1.91 to 5.62), interval PBC presentation (OR = 2.01, 95% CI 1.28 to 3.16), and heterogeneously dense breasts on mammography (OR = 1.54, 95% CI = 1.01 to 2.36) as independent predictors of interval-invasive second breast cancers. PBC diagnosis and treatment characteristics contribute to variation in subsequent-interval second breast cancer risk. Consideration of these factors may be useful in developing tailored post-treatment imaging surveillance plans. © The Author 2015. Published by Oxford University Press. All rights reserved

  19. Interpreting clinical trial results by deductive reasoning: In search of improved trial design.

    Science.gov (United States)

    Kurbel, Sven; Mihaljević, Slobodan

    2017-10-01

    Clinical trial results are often interpreted by inductive reasoning, in a trial design-limited manner, directed toward modifications of the current clinical practice. Deductive reasoning is an alternative in which results of relevant trials are combined in indisputable premises that lead to a conclusion easily testable in future trials. © 2017 WILEY Periodicals, Inc.

  20. The First Five Years of the Alpha Magnetic Spectrometer on the International Space Station

    CERN Multimedia

    CERN. Geneva

    2016-01-01

    In the five years since its installation on the International Space Station, it has collected more than 90 billion cosmic rays. Some of the unexpected results and their possible interpretations will be presented.

  1. Feasibility and pilot study of the effects of microfinance on mortality and nutrition in children under five amongst the very poor in India: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Ojha, Shalini; Szatkowski, Lisa; Sinha, Ranjeet; Yaron, Gil; Fogarty, Andrew; Allen, Stephen; Choudhary, Sunil; Smyth, Alan R

    2014-07-23

    The United Nations Millennium Development Goals include targets for the health of children under five years old. Poor health is linked to poverty and microfinance initiatives are economic interventions that may improve health by breaking the cycle of poverty. However, there is a lack of reliable evidence to support this. In addition, microfinance schemes may have adverse effects on health, for example due to increased indebtedness. Rojiroti UK and the Centre for Promoting Sustainable Livelihood run an innovative microfinance scheme that provides microcredit via women's self-help groups (SHGs). This pilot study, conducted in rural Bihar (India), will establish whether it is feasible to collect anthropometric and mortality data on children under five years old and to conduct a limited cluster randomized trial of the Rojiroti intervention. We have designed a cluster randomized trial in which participating tolas (small communities within villages) will be randomized to either receive early (SHGs and microfinance at baseline) or late intervention (SHGs and microfinance after 18 months). Using predesigned questionnaires, demographic, and mortality data for the last year and information about participating mothers and their children will be collected and the weight, height, and mid upper arm circumference (MUAC) of children will be measured at baseline and at 18 months. The late intervention group will establish SHGs and microfinance support at this point and data collection will be repeated at 36 months.The primary outcome measure will be the mean weight for height z-score of children under five years old in the early and late intervention tolas at 18 months. Secondary outcome measures will be the mortality rate, mean weight for age, height for age, prevalence of underweight, stunting, and wasting among children under five years of age. Despite economic progress, marked inequalities in child health persist in India and Bihar is one of the worst affected states. There

  2. Study protocol: non-displaced distal radial fractures in adult patients: three weeks vs. five weeks of cast immobilization: a randomized trial.

    Science.gov (United States)

    Bentohami, Abdelali; de Korte, Niels; Sosef, Nico; Goslings, Johan Carel; Bijlsma, Taco; Schep, Niels

    2014-01-20

    Up to 30% of patients suffer from long-term functional restrictions following conservative treatment of distal radius fractures. Whether duration of cast immobilisation influences functional outcome remains unclear. The aim of the study is to evaluate whether the duration of immobilization of non or minimally displaced distal radial fractures can be safely reduced. We will compare three weeks of plaster cast immobilization with five weeks of plaster cast immobilization in adult patient with non or minimally displaced distal radial fractures. a prospective randomized clinical trial. adult (>18 years) (independent in activities of daily living) patients with a non/minimal displaced distal radius fracture (dorsal angulation 15°, ulnar positive variance immobilization versus five weeks of plaster cast immobilization.Main study parameters: primary outcome parameters: Patient related wrist evaluation (PRWE) Quick Disability of Arm, Shoulder and Hand (QUICKDASH) score after a one year follow-up, and secondary parameters: range of motion, pain level (VAS) and complications. The expectation of this study is that shorter duration of plaster cast immobilisation is beneficial for the patient with a distal radius fracture. This risk of specific complications is low and generally similar in both treatment options. Moreover, the burden of the study is not much higher compared to standard treatment. Follow-up is standardized according to current trauma guidelines. Literature indicates that both treatment options from the study are accepted for displaced distal radius fractures. No clear advantage for one treatment options is found at present in the literature, although there is no level I evidence present. This trial will provide level-1 evidence for the comparison of consolidation and functional outcome between two treatment options for non-displaced distal radial fractures. The gathered data may support the development of a clinical guideline for conservative treatment of

  3. Civil partnerships five years on.

    Science.gov (United States)

    Ross, Helen; Gask, Karen; Berrington, Ann

    2011-01-01

    The Civil Partnership Act 2004, which came into force in December 2005 allowing same-sex couples in the UK to register their relationship for the first time, celebrated its fifth anniversary in December 2010. This article examines civil partnership in England and Wales, five years on from its introduction. The characteristics of those forming civil partnerships between 2005 and 2010 including age, sex and previous marital/civil partnership status are examined. These are then compared with the characteristics of those marrying over the same period. Further comparisons are also made between civil partnership dissolutions and divorce. The article presents estimates of the number of people currently in civil partnerships and children of civil partners. Finally the article examines attitudes towards same-sex and civil partner couples both in the UK and in other countries across Europe.

  4. Disseminating results to clinical trial participants: a qualitative review of patient understanding in a post-trial population.

    Science.gov (United States)

    Darbyshire, Julie Lorraine; Price, Hermione Clare

    2012-01-01

    To identify the most appropriate format for results dissemination to maximise understanding of trial results. Qualitative. Of the original 58 4-T trial centres, 34 agreed to take part in this ancillary research. All participants from these centres were eligible. All 343 participants were sent questionnaires. The low response rate meant that we were unable to make any firm conclusions about the patients' preferred method of dissemination; however, we were able to comment on the level of understanding demonstrated by the trial participants. All 40 (12%) returned questionnaires were received from 15 centres. We received no questionnaires from over half of the centres. The questionnaires which were returned demonstrated broad satisfaction with the results letter, general enthusiasm for the trial and a variable level of understanding of the results; however, there was a high proportion of responders who were not clear on why the research was undertaken or what the results meant. The low response rate may be related to delays during the trial set-up process suggesting that interest in a study quickly wanes for both patients and centres. From this we deduce that rapid dissemination of results is needed if it is to have any impact at all. The responders are likely to reflect a biased cohort who were both enthusiastic about the research and who had a good experience during their 3 years in the 4-T trial. It is perhaps not surprising therefore that the overview is positive. That this population was still not fully informed about the purpose of the research would seem to confirm a low level of understanding among the general public which we suggest should be addressed during the consent process.

  5. Idaho supplementation studies : five year report : 1992-1996

    International Nuclear Information System (INIS)

    Walters, Jody P.; Idaho. Dept. of Fish and Game; United States. Bonneville Power Administration. Division of Fish and Wildlife.

    1999-01-01

    In 1991, the Idaho Supplementation Studies (ISS) project was implemented to address critical uncertainties associated with hatchery supplementation of chinook salmon Oncorhynchus tshawytscha populations in Idaho. The project was designed to address questions identified in the Supplementation Technical Work Group (STWG) Five-Year-Workplan (STWG 1988). Two goals of the project were identified: (1) assess the use of hatchery chinook salmon to increase natural populations in the Salmon and Clearwater river drainages, and (2) evaluate the genetic and ecological impacts of hatchery chinook salmon on naturally reproducing chinook salmon populations. Four objectives to achieve these goals were developed: (1) monitor and evaluate the effects of supplementation on presmolt and smolt numbers and spawning escapements of naturally produced fish; (2) monitor and evaluate changes in natural productivity and genetic composition of target and adjacent populations following supplementation; (3) determine which supplementation strategies (broodstock and release stage) provide the quickest and highest response in natural production without adverse effects on productivity; and (4) develop supplementation recommendations. This document reports on the first five years of the long-term portion of the ISS project. Small-scale studies addressing specific hypotheses of the mechanisms of supplementation effects (e.g., competition, dispersal, and behavior) have been completed. Baseline genetic data have also been collected. Because supplementation broodstock development was to occur during the first five years, little evaluation of supplementation is currently possible. Most supplementation adults did not start to return to study streams until 1997. The objectives of this report are to: (1) present baseline data on production and productivity indicators such as adult escapement, redd counts, parr densities, juvenile emigrant estimates, and juvenile survival to Lower Granite Dam (lower Snake

  6. The International (Ludwig) Breast Cancer Study Group Trials I-IV: 15 years follow-up.

    Science.gov (United States)

    Castiglione-Gertsch, M; Johnsen, C; Goldhirsch, A; Gelber, R D; Rudenstam, C M; Collins, J; Lindtner, J; Hacking, A; Cortes-Funes, H; Forbes, J

    1994-10-01

    Adjuvant systemic therapy prolongs disease-free and overall survival in both pre- and postmenopausal patients. Available data shown benefit from multi-agent chemotherapy, prolonged tamoxifen treatment, and ovarian ablation, and that the combination of chemo- and endocrine therapy might be advantageous. In 1978 the International (Ludwig) Breast Cancer Study Group (IBCSG) initiated four complementary randomized controlled clinical trials to evaluate the roles of chemo-endocrine combinations or endocrine therapy alone in specific populations defined by risk (for pre- and perimenopausal patients) or by age (for postmenopausal patients). The results at 10 and 13 years' median follow-up for these trials are summarized in this report and are compared to those of the Overview meta-analysis with regard to chemo-endocrine or endocrine therapy combinations. Furthermore, types of first relapses by sites and second malignant diseases are reported. 1601 evaluable patients with node positive disease were included into the studies I-IV. In Trial I (491 premenopausal patients with 1-3 positive axillary nodes) we studied the addition of low-dose continuous prednisone (p) to a cyclophosphamide-methotrexate-fluorouracil (CMF) combination. In Trial II 327 premenopausal patients with four or more positive axillary nodes were randomized to one year CMFp or to a surgical oophorectomy followed by CMFp. In Trial III (463 postmenopausal patients 65 years old or younger), combined chemoendocrine therapy (one year of CMFp plus tamoxifen (T)) was compared to endocrine therapy (1 year of p + T) or to surgery alone. In Trial IV 320 postmenopausal patients 66 to 80 years old were treated either by surgery alone or by surgery followed by 1 year prednisone and tamoxifen. In Trial I the addition of prednisone allowed a higher dose of cytotoxics to be administered compared with CMF alone. Despite this increased dose intensity, 13-year disease-free survival (DFS) and overall survival (OS) were similar

  7. Retrospective Evaluation of the Five-Year and Ten-Year CSEP-Italy Earthquake Forecasts

    OpenAIRE

    Werner, M. J.; Zechar, J. D.; Marzocchi, W.; Wiemer, S.

    2010-01-01

    On 1 August 2009, the global Collaboratory for the Study of Earthquake Predictability (CSEP) launched a prospective and comparative earthquake predictability experiment in Italy. The goal of the CSEP-Italy experiment is to test earthquake occurrence hypotheses that have been formalized as probabilistic earthquake forecasts over temporal scales that range from days to years. In the first round of forecast submissions, members of the CSEP-Italy Working Group presented eighteen five-year and ten...

  8. Twenty-five years of simulator training

    International Nuclear Information System (INIS)

    Anon.

    2002-01-01

    The first training simulator for nuclear power plant personnel in Germany was commissioned twenty-five years ago. The strategy of training by simulators was developed and pursued consistently and continuously in order to ensure sound training of nuclear power plant personnel. The present thirteen simulators cover a broad range of plants. A systematic training concept also helps to ensure a high level of competence and permanent qualification of plant personnel. The anniversary was marked by a festive event at which Erich K. Steiner read a paper on 'The Importance of Simulator Training', and Professor Dr. Adolf Birkhofer spoke about 'Nuclear Technology Education and Training'. (orig.)

  9. A Study Of Universal Immunization Coverage During Last Five Years In Resettlement Colonies Of Delhi

    Directory of Open Access Journals (Sweden)

    Salhotra V S

    1999-01-01

    Full Text Available Research Question: Is there any difference in immunization coverage in resettlement colonies of Delhi during past five years? Objectives: 1. To study the immunization coverage levels of children over a period of five years. 2. To observe changes in the coverage levels of different years, if any. Study design: Cross-sectional study. Setting: Khichripur, Kalyanpuri, Kalyanpuri, Trilokpuri and Himmatpuri- four resettlement colonies of trans-Yamuna area of Delhi. Participants: 1500 children belonging to five age-groups i.e. birth-1 yr., 1-2 yrs., 2-3 yrs, and 4-5 yrs. Methods: Verification of child’s immunization from immunization card and interview of mother if immunization car was not available. Study period: May1997 to March1998 Results: Immunization with individual vaccines and immunization status of the children peaked in 1995-96 but started falling thereafter due to fall in ICE activities.

  10. Results of the radiologic emergencies response in the state of Sao Paulo during the last five years

    International Nuclear Information System (INIS)

    Boni-Mitake, Malvina; Suzuki, Fabio F.; Nicolau, Jose R.A.; Rodrigues, Demerval L.

    2001-01-01

    Radiation is often associated with bombs, diseases, and destruction rather than with the many benefits of nuclear technology that are present in the daily life. The radiation risk symbol still frightens the population. In addition, small risks related to nuclear area are overestimated. So, when there is a radiological accident, a prompt response is necessary because some of its major deleterious impacts are not quantified just in terms of radiation dose, but they are related to the risk perceived, and in many cases, wrong information or just lack of information induces fear or anxiety. In case of unusual situations involving radiation sources in Sao Paulo State, the people can contact IPEN-CNEN/SP Nuclear and Radiological Emergency Response Team by telephone. The objective of this paper is to show the results obtained in the last five years. In this period, there were 89 calls. About half of those calls were performed by intervening organizations, as Fire Department or Civil Defense. Most of the situations presented low potential risks and some did not involve radiation sources. The results indicate that arrangements should be made for training the intervening organization personnel, which usually are the first ones that arrive at the emergency scene, in fundamentals of radiological protection, including both theoretical and practical aspects. Moreover, major efforts should be intended to divulge and clarify the public about the peaceful uses of nuclear technology, focusing the safety requirements and the regulatory control over the radiation sources. (author)

  11. Do prebiotics reduce the number of fever episodes in healthy children in their first year of life : a randomised controlled trial

    NARCIS (Netherlands)

    van Stuijvenberg, Margriet; Eisses, Annemieke M.; Gruber, Christoph; Mosca, Fabio; Arslanoglu, Sertac; Chirico, Gaetano; Braegger, Christian P.; Riedler, Josef; Boehm, Gunther; Sauer, Pieter J. J.

    2011-01-01

    The objective of the present study was to assess the effect of adding specific prebiotics to standard formula feeding on the number of fever episodes in the first year of life. In the present randomised, double-blind, placebo-controlled trial in seven centres in five West European countries, 830

  12. Five Year Outcome of 145 Patients With Ductal Carcinoma In Situ (DCIS) After Accelerated Breast Radiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Ciervide, Raquel [Department of Radiation Oncology, New York University School of Medicine, NYU Langone Medical Center, New York, New York (United States); Dhage, Shubhada; Guth, Amber; Shapiro, Richard L.; Axelrod, Deborah M.; Roses, Daniel F. [Department of Surgery, New York University School of Medicine, NYU Langone Medical Center, New York, New York (United States); Formenti, Silvia C., E-mail: silvia.formenti@nyumc.org [Department of Radiation Oncology, New York University School of Medicine, NYU Langone Medical Center, New York, New York (United States)

    2012-06-01

    Background: Accelerated whole-breast radiotherapy (RT) with tumor bed boost in the treatment of early invasive breast cancer has demonstrated equivalent local control and cosmesis when compared with standard RT. Its efficacy in the treatment of ductal carcinoma in situ (DCIS) remains unknown. Methods and Materials: Patients treated for DCIS with lumpectomy and negative margins were eligible for 2 consecutive hypofractionated whole-breast RT clinical trials. The first trial (New York University [NYU] 01-51) prescribed to the whole breast 42 Gy (2.8 Gy in 15 fractions) and the second trial (NYU 05-181) 40.5 Gy (2.7 Gy in 15 fractions) with an additional daily boost of 0.5 Gy to the surgical cavity. Results: Between 2002 and 2009, 145 DCIS patients accrued, 59 to the first protocol and 86 to the second trial. Median age was 56 years and 65% were postmenopausal at the time of treatment. Based on optimal sparing of normal tissue, 79% of the patients were planned and treated prone and 21% supine. At 5 years' median follow-up (60 months; range 2.6-105.5 months), 6 patients (4.1%) experienced an ipsilateral breast recurrence in all cases of DCIS histology. In 3/6 patients, recurrence occurred at the original site of DCIS and in the remaining 3 cases outside the original tumor bed. New contralateral breast cancers arose in 3 cases (1 DCIS and 2 invasive carcinomas). Cosmetic self-assessment at least 2 years after treatment is available in 125 patients: 91% reported good-to-excellent and 9% reported fair-to-poor outcomes. Conclusions: With a median follow-up of 5 years, the ipsilateral local recurrence rate is 4.1%, comparable to that reported from the NSABP (National Surgical Adjuvant Breast and Bowel Project) trials that employed 50 Gy in 25 fractions of radiotherapy for DCIS. There were no invasive recurrences. These results provide preliminary evidence that accelerated hypofractionated external beam radiotherapy is a viable option for DCIS.

  13. Remotely Operated Vehicles under sea ice - Experiences and results from five years of polar operations

    Science.gov (United States)

    Katlein, Christian; Arndt, Stefanie; Lange, Benjamin; Belter, Hans Jakob; Schiller, Martin; Nicolaus, Marcel

    2016-04-01

    The availability of advanced robotic technologies to the Earth Science community has largely increased in the last decade. Remotely operated vehicles (ROV) enable spatially extensive scientific investigations underneath the sea ice of the polar oceans, covering a larger range and longer diving times than divers with significantly lower risks. Here we present our experiences and scientific results acquired from ROV operations during the last five years in the Arctic and Antarctic sea ice region. Working under the sea ice means to have all obstacles and investigated objects above the vehicle, and thus changes several paradigms of ROV operations as compared to blue water applications. Observations of downwelling spectral irradiance and radiance allow a characterization of the optical properties of sea ice and the spatial variability of the energy partitioning across the atmosphere-ice-ocean boundary. Our results show that the decreasing thickness and age of the sea ice have led to a significant increase in light transmission during summer over the last three decades. Spatially extensive measurements from ROV surveys generally provide more information on the light field variability than single spot measurements. The large number of sampled ice conditions during five cruises with the German research icebreaker RV Polarstern allows for the investigations of the seasonal evolution of light transmittance. Both, measurements of hyperspectral light transmittance through sea ice, as well as classification of upward-looking camera images were used to investigate the spatial distribution of ice-algal biomass. Buoyant ice-algal aggregates were found to be positioned in the stretches of level ice, rather than pressure ridges due to a physical interaction of aggregate-buoyancy and under-ice currents. Synchronous measurements of sea ice thickness by upward looking sonar provides crucial additional information to put light-transmittance and biological observations into context

  14. Relationship Between Mothers’ Role and Knowledge in Recurrence Prevention of Food Allergy for Children Under Five Years-Old

    Directory of Open Access Journals (Sweden)

    Fitria Rinawarti

    2017-04-01

    Full Text Available There are 30-40% of people with allergies world wide in 2011, this is based on data from the Center for Disease Control and Prevention (CDC more than tripled from 1993 to 2006. Parents play an important role in overcoming the recurrence of allergies in children in order of recurrence allergies and more severe recurrence. The goal of the study is to analyze association mothers’s role and knowledge in recurrence prevention of food allergy in children under five years-old. The study is an analytic observational research with cross sectional design. Method of sampling usedis simple random sampling. The samples were 39 mothers who have children under five years-old with food allergy in Rumah Sakit Islam Jemursari Surabaya. Analysis used chi-square test with α = 0.05 significance level.The results revealed the knowledge of mothers’ with allergy recurrance is 15 person (38,5% have a good knowledge in prevention of food allergy in children under five years-old, while mothers’s role in recurrence prevention of food allergy in children under five years-old is 26 person (66,7% have a role unfavorable. The statistical test by using chi-square revealed there were association between mothers’role (ρ=0,030 and mother’s of knowledge (ρ=0,00001in recurrence prevention of food allergy for children under five years-old.The conclusions of the results this study is mothers’s role with unfavorable to have children under five years-old with an allergy recurrence of severe allergy, while mothers with good knowledge to have children under five years-old with an allergy reccurrance of mild allergy. Keywords: recurrence allergies, mother’s role, mother’s knowledge

  15. Louisiana Airport System Plan Five-Year Capital Improvement Program.

    Science.gov (United States)

    1992-07-01

    The Louisiana Airport System Plan (LASP) Five-Year-Capital Improvement Program (CIP) is a development plan for all commercial service, reliever, and general aviation airports in Louisiana. It is a detailed listing of potential projects based on the a...

  16. General RMP Guidance - Chapter 3: Five-Year Accident History

    Science.gov (United States)

    This involves the reporting of significant accidental releases of one or more of the regulated toxic or flammable substances from a covered process in the five years prior to the submission of an initial or updated Risk Management Plan.

  17. Prevalence of rotavirus among children under five years of age with ...

    African Journals Online (AJOL)

    2016-08-16

    Aug 16, 2016 ... acute diarrhea in children under five years in Kaduna State, Nige- ria. Hence the need to introduce the vaccines into the childhood immunization program in the country. Keywords: Prevalence, Rotavirus,. Children, Kaduna State, Nigeria. Introduction. Diarrheal disease kills 1.8 million children under five.

  18. Effect of maternal Schistosoma mansoni infection and praziquantel treatment during pregnancy on Schistosoma mansoni infection and immune responsiveness among offspring at age five years.

    Directory of Open Access Journals (Sweden)

    Robert Tweyongyere

    Full Text Available Offspring of Schistosoma mansoni-infected women in schistosomiasis-endemic areas may be sensitised in-utero. This may influence their immune responsiveness to schistosome infection and schistosomiasis-associated morbidity. Effects of praziquantel treatment of S. mansoni during pregnancy on risk of S. mansoni infection among offspring, and on their immune responsiveness when they become exposed to S. mansoni, are unknown. Here we examined effects of praziquantel treatment of S. mansoni during pregnancy on prevalence of S. mansoni and immune responsiveness among offspring at age five years.In a trial in Uganda (ISRCTN32849447, http://www.controlled-trials.com/ISRCTN32849447/elliott, offspring of women treated with praziquantel or placebo during pregnancy were examined for S. mansoni infection and for cytokine and antibody responses to SWA and SEA, as well as for T cell expression of FoxP3, at age five years.Of the 1343 children examined, 32 (2.4% had S. mansoni infection at age five years based on a single stool sample. Infection prevalence did not differ between children of treated or untreated mothers. Cytokine (IFNγ, IL-5, IL-10 and IL-13 and antibody (IgG1, Ig4 and IgE responses to SWA and SEA, and FoxP3 expression, were higher among infected than uninfected children. Praziquantel treatment of S. mansoni during pregnancy had no effect on immune responses, with the exception of IL-10 responses to SWA, which was higher in offspring of women that received praziquantel during pregnancy than those who did not.We found no evidence that maternal S. mansoni infection and its treatment during pregnancy influence prevalence and intensity of S. mansoni infection or effector immune response to S. mansoni infection among offspring at age five years, but the observed effects on IL-10 responses to SWA suggest that maternal S. mansoni and its treatment during pregnancy may affect immunoregulatory responsiveness in childhood schistosomiasis. This might have

  19. Environmental restoration and waste management five-year plan, Fiscal years 1994--1998

    International Nuclear Information System (INIS)

    1993-01-01

    The US Department of Energy (DOE) understands that cleaning up the Nation's nuclear-related sites and facilities affects many different segments of the public, ranging from communities near DOE facilities to engineers concerned with developing new technologies to clean up the environment. In an effort to make the Environmental Restoration and Waste Management Five-Year Plan for Fiscal Years (FY) 1994--1998 more responsive to your concerns, DOE invites your comments on the plan. Volume II contains 37 Installation Summaries that provide a synopsis of past, present and future activities of each major installation, and Progress Charts

  20. A Pharmaceutical Bioethics Consultation Service: Six-Year Descriptive Characteristics and Results of a Feedback Survey.

    Science.gov (United States)

    Van Campen, Luann E; Allen, Albert J; Watson, Susan B; Therasse, Donald G

    2015-04-03

    Background : Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey. Methods : Data on the descriptive characteristics of bioethics consultations were collected from 2008 to 2013 and analyzed in Excel 2007. Categorical data were analyzed via the pivot table function, and time-based variables were analyzed via formulas. The feedback survey was administered to consultation requesters from 2009 to 2012 and also analyzed in Excel 2007. Results : Over the 6-year period, 189 bioethics consultations were conducted. The number of consultations increased from five per year in 2008 to approximately one per week in 2013. During this time, the format of the consultation service was changed from a committee-only approach to a tiered approach (tailored to the needs of the case). The five most frequent topics were informed consent, early termination of a clinical trial, benefits and risks, human biological samples, and patient rights. The feedback survey results suggest the consultation service is well regarded overall and viewed as approachable, helpful, and responsive. Conclusions : Pharmaceutical bioethics consultation is a unique category of bioethics consultation that primarily focuses on pharmaceutical research and development but also touches on aspects of clinical ethics, business ethics, and organizational ethics. Results indicate there is a demand for a tiered bioethics consultation service within this pharmaceutical company and that advice was valued. This company's experience indicates that a bioethics consultation service

  1. The external quality assessment scheme: Five years experience as a participating laboratory

    Directory of Open Access Journals (Sweden)

    Chaudhary Rajendra

    2010-01-01

    Full Text Available Background and Aim : Quality assurance in blood banking includes active participation in the external quality program. Such a program offers valuable benefits to patient care, their safety, and an overall quality of laboratory practices. In the year 2002, we participated in the External Quality Assessment Scheme (EQAS under the World Health Organization (WHO, Bureau of Laboratory Quality Standards, Thailand. Materials and Methods: In the current study we evaluated our EQAS test result of the past five years, from 2003 to 2007. Test results of all blood samples such as ABO grouping, D typing, antibody screening, antibody identification, and transfusion transmitted infection (TTI testing were analyzed and documented. Results: Discordant results in one or more instances were observed with antibody identification, weak D testing, and tests for anti-HIV1/2 and HBsAg. Twice we failed to detect the ′anti-Mia′ antibody in the issued sample and that could be attributed to the absence of the corresponding antigen in the used cell panel. HBsAg was missed due to its critically low titer in the serum and the comparatively low sensitivity of our Enzyme-Linked Immunosorbent Assay (ELISA test kit. Conclusion: All these failures in the last five years have helped us to significantly improve our transfusion service in terms of performance evaluation, patient care and safety issues, and the overall quality of laboratory practices. We therefore recommend all laboratories and hospitals to participate in the EQAS program, which will definitely help them to improve from what they learn.

  2. Influences of the Big Five personality traits on the treatment response and longitudinal course of depression in patients with acute coronary syndrome: A randomised controlled trial.

    Science.gov (United States)

    Kim, Seon-Young; Stewart, Robert; Bae, Kyung-Yeol; Kim, Sung-Wan; Shin, Il-Seon; Hong, Young Joon; Ahn, Youngkeun; Jeong, Myung Ho; Yoon, Jin-Sang; Kim, Jae-Min

    2016-10-01

    Influences of the Big Five personality traits on the treatment response and longitudinal course of depression in patients with acute coronary syndrome: A randomised controlled trial. This naturalistic observational study initially recruited 1152 ACS patients; 685 patients completed personality assessments at baseline, of whom 630 were followed-up one year later. Of the 294 patients with depression, 207 participated in a 24-week double blind trial of escitalopram or placebo. The remaining 87 patients who received medical treatment only and the 391 who had not depression were also followed in a one year naturalistic observational study. The Big five personality traits were assessed using the Big Five Inventory. The influences of personality on the Hamilton Depression Rating Scale score changes were analysed using a mixed-model repeated-measures analysis of covariance. A Cluster analysis identified two personality types: resilient and vulnerable. The vulnerable personality type was characterized by lower extraversion, agreeableness, and conscientiousness - but higher neuroticism - than the resilient type. This personality type was independently associated with a poorer outcome of depression in ACS patients during the 24-week treatment period and the one year longitudinal follow-up period compared to the resilient personality type, irrespective of treatment allocation. Recruitment from a single institution may limit generalisability. Personality traits were investigated 12-weeks after ACS; thus, the responses may have been influenced by the prior receipt of escitalopram. Personality types influences the treatment outcome and longitudinal course of depression in ACS patients independent of antidepressant treatment. Copyright © 2016 Elsevier B.V. All rights reserved.

  3. SCANDCLEFT RANDOMIZED TRIALS: SPEECH OUTCOMES IN 5-YEAR-OLDS WITH UCLP - velopharyngeal competency and hypernasality

    DEFF Research Database (Denmark)

    Lohmander, Anette; Persson, Christina; Willadsen, Elisabeth

    2017-01-01

    Background and aim: Adequate velopharyngeal function and speech are main goals in the treatment of cleft palate. The objective was to investigate if there were differences in velopharyngeal competency (VPC) and hypernasality at age 5 years in children with unilateral cleft lip and palate (UCLP...... (136 girls, 255 boys) were available and perceptually analysed. The main outcome measures were VPC and hypernasality from blinded assessments. Results: There were no statistically significant differences between the prevalences in the arms in any of the trials. VPC: Trial 1, A: 58%, B: 61%; Trial 2, A......: 57%, C: 54%; Trial 3, A: 35%, D: 51%. No hypernasality: Trial 1, A: 54%, B: 44%; Trial 2, A: 47%, C: 51%; Trial 3, A: 34%, D: 49%. Conclusions: No differences were found regarding VPC and hypernasality at age 5 years after different methods for primary palatal repair. The burden of care in terms...

  4. Parotid tumor statistics for the past five years

    International Nuclear Information System (INIS)

    Yamaguchi, Soichi; Sueno, Kohei; Yamaguchi, Takeshi; Asano, Yukimi; Shiba, Kazutaka; Sekiguchi, Nao; Masuda, Takeshi

    2004-01-01

    We reviewed the case of 40 patients with parotid tumor who underwent an operation in the past five years. The patients included 23 (57.5%) males and 17 (42.5%) females. The average age was 53.4 years old with a range of 19 to 71 years. Thirty eight (95.0%) had benign tumor, and 2 (5.0%) had malignant tumor. Tc scintigraphy was performed in 37 out of the 40 patients, and 9 patients showed positive results. Six patients had warthin's tumor, and 3 had pleomorphic adenoma. In other words, 66.7% were positive for warthin's tumor. Ga scintigraphy was performed in 31 out of the 40 patients. Nine were positive out of the 10 benign tumor that showed a positive result. None of the cases had permanent facial palsy as a postoperative complication. Transient facial palsy was exhibited by 13 patients (32.5%), but they all improved 2 weeks to 6 months. In addition, we experienced 1 case of salivary fistula. Pleomorphic adenoma was noted in 63.2%, and warthin's tumor in 23.7%. There was no gender difference for pleomorphic adenoma, but 8 out of the 9 patients with warthin's tumor were men. The average age was 47.0 for pleomorphic adenoma and 58.7 for warthin's tumor which was in accordance with conventional reports. The Tc scintigraphy positive rate of warthin's tumor was low, 66.7%, in comparison with that in conventional reports. In addition, 90% of the tumors that showed positive results in Ga scintigraphy were preoperatively positive tumors, indicating the diagnostic usefulness of this. Transient facial palsy was a complication in 32.5% of the patients, which was similar to the rate in the conventional report. We experienced 1 case salivary fistula, which did not improve with conservative treatment. We opened the wounded area, and drained it by pressing. (author)

  5. A Five-Year Review of Tag Rugby Hand Injuries.

    Science.gov (United States)

    Joyce, C W; Woods, J F C; Murphy, S; Bollard, S; Kelly, J L; Carroll, S M; O'Shaughnessy, M

    2016-10-01

    Tag rugby is one of the fastest growing sports in Ireland. It is a soft-contact team game that is loosely based on the rugby league format except players try to remove Velcro tags from their opponents' shorts rather than engage in a typical rugby tackle. The purpose of this study was to examine all tag rugby associated hand injuries over a five-year period in three large tertiary referral hospitals in Ireland. Using the patient corresponding system, 228 patients with hand injury related tag rugby injuries were observed from 2010 to 2015. There were 138 males and 90 females in the study and over 40% of patients required surgery. Most of the patients were young professionals with an average age of 30. Twenty-five patients worked in the financial services whilst there were 23 teachers. Fractures accounted for 124 of the 228 injuries and mallet injuries accounted for 53. Eighty percent of all injuries occurred during the tackle. The mean number of days missed from work was 9.1±13.8 days. These injuries resulted in an average of seven hospital appointments per patient. Considering it is a soft-contact sport, it is surprising the number of hand injuries that we have observed. Although safety measures have been introduced to decrease the number of hand injuries in recent years, there is a need for further improvements. Better player education about seeking prompt medical attention once an injury occurs, coupled with longer shorts worn by players may improve measures for the sport. Copyright © 2016. Published by Elsevier Ltd.

  6. The 2015 Five-yearly review: diversity in the spotlight

    CERN Multimedia

    Staff Association

    2014-01-01

    Introduction As mentioned in Echo 201, with the Council Decision of last June the CERN 2015 five-yearly review has formally begun. Following the procedure defined in Annex A1 of the Staff Rules and Regulations CERN will thus review its financial and social conditions that should enable it to recruit from all its Member States, and retain, staff of the highest competence and integrity necessary to perform its mission. In addition, these conditions should increase the attractiveness of CERN in all Member States and motivate staff of all ages and all occupations throughout their careers. Annex A1 stipulates that a five-yearly review must include basic salaries (stipends for Fellows and subsistence allowances for associated members of the personnel) and, optionally, may include any other financial or social conditions. For this optional part of the 2015 exercise, the CERN career structure and measures to improve diversity were chosen. Towards a better diversity policy The analysis of the 2013 Staff Associat...

  7. Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

    Science.gov (United States)

    Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

    2017-12-01

    Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (ppublication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

  8. Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial.

    Science.gov (United States)

    Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C

    2016-06-01

    The Systolic Blood Pressure Intervention Trial is a multicenter, randomized clinical trial of 9361 participants with hypertension who are ≥50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal recruitment strategies and lessons learned during recruitment of the Systolic Blood Pressure Intervention Trial cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥75 years, women, and minorities. In collaboration with the National Institutes of Health Project Office and Systolic Blood Pressure Intervention Trial Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began on 8 November 2010 and ended on 15 March 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Recruitment was scheduled to last 24 months to enroll a target of 9250 participants; in just over 28 months, the trial enrolled 9361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by Systolic Blood Pressure Intervention Trial staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, Internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized/number screened) was 64% (9361 randomized/14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those aged ≥75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional

  9. Progression of MDS-UPDRS Scores Over Five Years in De Novo Parkinson Disease from the Parkinson's Progression Markers Initiative Cohort.

    Science.gov (United States)

    Holden, Samantha K; Finseth, Taylor; Sillau, Stefan H; Berman, Brian D

    2018-01-01

    The Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UDPRS) is a commonly used tool to measure Parkinson disease (PD) progression. Longitudinal changes in MDS-UPDRS scores in de novo PD have not been established. Determine progression rates of MDS-UPDRS scores in de novo PD. 362 participants from the Parkinson's Progression Markers Initiative, a multicenter longitudinal cohort study of de novo PD, were included. Longitudinal progression of MDS-UPDRS total and subscale scores were modeled using mixed model regression. MDS-UPDRS scores increased in a linear fashion over five years in de novo PD. MDS-UPDRS total score increased an estimated 4.0 points/year, Part I 0.25 points/year, Part II 1.0 points/year, and Part III 2.4 points/year. The expected average progression of MDS-UPDRS scores in de novo PD from this study can assist in clinical monitoring and provide comparative data for detection of disease modification in treatment trials.

  10. Personality and medication non-adherence among older adults enrolled in a six-year trial

    Science.gov (United States)

    Jerant, Anthony; Chapman, Benjamin; Duberstein, Paul; Robbins, John; Franks, Peter

    2011-01-01

    Objectives Personality factors parsimoniously capture the variation in dispositional characteristics that affect behaviours, but their value in predicting medication non-adherence is unclear. We investigated the relationship between five-factor model personality factors (Conscientiousness, Neuroticism, Agreeableness, Extraversion, and Openness) and medication non-adherence among older participants during a six-year randomized placebo-controlled trial (RCT). Design Observational cohort data from 771 subjects aged ≥72 years enrolled in the Ginkgo Evaluation of Memory study, a RCT of Ginkgo biloba for prevention of dementia. Methods Random effects logistic regression analyses examined effects of NEO Five-Factor Inventory scores on medication non-adherence, determined via pill counts every 6 months (median follow-up 6.1 years) and defined as taking personality factor associated with non-adherence: a 1 SD increase was associated with a 3.8% increase in the probability of non-adherence (95% CI [0.4, 7.2]). Lower cognitive function was also associated with non-adherence: a 1 SD decrease in mental status exam score was associated with a 3.0% increase in the probability of non-adherence (95% CI [0.2, 5.9]). Conclusions Neuroticism was associated with medication non-adherence over 6 years of follow-up in a large sample of older RCT participants. Personality measurement in clinical and research settings might help to identify and guide interventions for older adults at risk for medication non-adherence. PMID:21226789

  11. High School Students with Reading Comprehension Difficulties: Results of a Randomized Control Trial of a Two-Year Reading Intervention

    Science.gov (United States)

    Vaughn, Sharon; Roberts, Greg; Wexler, Jade; Vaughn, Michael G.; Fall, Anna-Mária; Schnakenberg, Jennifer B.

    2015-01-01

    A 2-year, randomized control trial with 9th to 10th grade students with significant reading problems was provided for 50 minutes a day in small groups. Comparison students were provided an elective class and treatment students the reading intervention. Students were identified as demonstrating reading difficulties through failure on their state…

  12. Predictive value of developmental testing in the second year for cognitive development at five years of age

    Directory of Open Access Journals (Sweden)

    Alastair G Sutcliffe

    2010-09-01

    Full Text Available There is mixed evidence about the predictive validity of the Griffiths mental developmental scales. This study aimed to assess the predictive value of developmental assessments of children in their second year using the Griffiths mental development scales for neuro-developmental status at five years using the Wechsler preschool and primary scale of intelligence, revised (WPPSI-R. In a longitudinal study 253 children were assessed in their second year of life using the Griffiths scales and again at five years using the WPPSI-R. The scores were compared and the predictability of the WPPSI-R outcome on the basis of Griffiths scores was assessed. The WPPSI-R full scale IQ and the performance IQ at age five could be predicted moderately by the Griffiths general quotient (GQ and by the personal/social scale. The Griffiths GQ was not a significant predictor of verbal IQ at age 5. The Griffiths performance scale predicted subsequent WPPSI-R performance IQ, and marginally the Full Scale IQ. For the early identification of children at risk for language delay, the Griffiths scales may not be suitable. However, a shortened form would be useful to predict overall cognitive development from the second year to school entry, focussing on the personal-social and performance scales.

  13. Cost-effectiveness analysis of screening for abdominal aortic aneurysms based on five year results from a randomised hospital based mass screening trial

    DEFF Research Database (Denmark)

    Lindholt, Jes S.; Juul, Svend; Fasting, Helge

    2006-01-01

    BACKGROUND: The aim of this study was to estimate the cost effectiveness of screening for abdominal aortic aneurysm (AAA). MATERIAL AND METHODS: All 12,639 men born in the years 1921-1933 (aged 64-73) living in Viborg County, Denmark, were randomly allocated either to receive an invitation...... to abdominal ultrasound scanning for AAA or to be controls. Costs for screening and surveillance were assessed prospectively. Diagnosis Related Group (DRG) costs from 1999 were used concerning admissions with uncomplicated and complicated operations. Admissions for AAA surgery were retrospectively classified...... group (P = 0.003). The costs were estimated to be Euro 11.23 per scan. The costs per life-year saved were Euro 9057 (Euro 5872-20,063) after 5 years, and were expected to decrease to Euro 2708 (Euro 1758-6031) after 10 years and to Euro 1825 (Euro 1185-4063) after 15 years. CONCLUSION: Screening of 64...

  14. THE FIVE YEAR FERMI/GBM MAGNETAR BURST CATALOG

    Energy Technology Data Exchange (ETDEWEB)

    Collazzi, A. C. [SciTec, Inc., 100 Wall Street, Princeton, NJ 08540 (United States); Kouveliotou, C.; Horst, A. J. van der; Younes, G. A. [Department of Physics, The George Washington University, 725 21st Street NW, Washington, DC 20052 (United States); Kaneko, Y.; Göğüş, E. [Sabancı University, Orhanlı-Tuzla, İstanbul 34956 (Turkey); Lin, L. [François Arago Centre, APC, 10 rue Alice Domon et Léonie Duquet, F-75205 Paris (France); Granot, J. [Department of Natural Sciences, The Open University of Israel, 1 University Road, P.O. Box 808, Raanana 43537 (Israel); Finger, M. H. [Universities Space Research Association, NSSTC, 320 Sparkman Drive, Huntsville, AL 35805 (United States); Chaplin, V. L. [School of Medicine, Vanderbilt University, 1161 21st Avenue S, Nashville, TN 37232 (United States); Huppenkothen, D. [Center for Data Science, New York University, 726 Broadway, 7th Floor, New York, NY 10003 (United States); Watts, A. L. [Anton Pannekoek Institute, University of Amsterdam, Postbus 94249, 1090 GE Amsterdam (Netherlands); Kienlin, A. von [Max-Planck-Institut für extraterrestrische Physik, Giessenbachstrasse 1, D-85748 Garching (Germany); Baring, M. G. [Department of Physics and Astronomy, Rice University, MS-108, P.O. Box 1892, Houston, TX 77251 (United States); Gruber, D. [Planetarium Südtirol, Gummer 5, I-39053 Karneid (Italy); Bhat, P. N. [CSPAR, University of Alabama in Huntsville, 320 Sparkman Drive, Huntsville, AL 35899 (United States); Gibby, M. H., E-mail: acollazzi@scitec.com [Jacobs Technology, Inc., Huntsville, AL (United States); and others

    2015-05-15

    Since launch in 2008, the Fermi Gamma-ray Burst Monitor (GBM) has detected many hundreds of bursts from magnetar sources. While the vast majority of these bursts have been attributed to several known magnetars, there is also a small sample of magnetar-like bursts of unknown origin. Here, we present the Fermi/GBM magnetar catalog, providing the results of the temporal and spectral analyses of 440 magnetar bursts with high temporal and spectral resolution. This catalog covers the first five years of GBM magnetar observations, from 2008 July to 2013 June. We provide durations, spectral parameters for various models, fluences, and peak fluxes for all the bursts, as well as a detailed temporal analysis for SGR J1550–5418 bursts. Finally, we suggest that some of the bursts of unknown origin are associated with the newly discovered magnetar 3XMM J185246.6+0033.7.

  15. Prevalence of rotavirus diarrhoea among children under five years ...

    African Journals Online (AJOL)

    Rotavirus (RV) is a major etiological agent of acute infantile gastroenteritis and is associated with 20%-25% of diarrhoea cases in infants. Nigeria continues to be among the first five countries with greatest number of RV disease associated deaths per year. From September 2013-August 2014, 467 stool samples were ...

  16. Five-year change in physical activity is associated with changes in cardiovascular disease risk factors: the Inter99 study

    DEFF Research Database (Denmark)

    Aadahl, Mette; von Huth Smith, L; Pisinger, Charlotte

    2009-01-01

    OBJECTIVE: To evaluate whether five-year changes in self-reported physical activity level were associated with changes in waist circumference, weight, serum lipids and blood pressure. METHODS: In the Inter99 study (1999-2006) in Copenhagen, Denmark, 4039 men and women (30-60 years) answered quest....... Change in physical activity level induced a significant change in HDL concentration in men only. Women's use of hormone replacement therapy may partly explain this gender difference.......OBJECTIVE: To evaluate whether five-year changes in self-reported physical activity level were associated with changes in waist circumference, weight, serum lipids and blood pressure. METHODS: In the Inter99 study (1999-2006) in Copenhagen, Denmark, 4039 men and women (30-60 years) answered...... questions on lifestyle and provided blood samples and anthropometric measures at baseline and after five years. Multiple regression analyses were performed with five-year value of each cardiovascular biomarker as outcome and change in physical activity level as explanatory variable. RESULTS: Approximately...

  17. Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial (SPRINT)

    Science.gov (United States)

    Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C

    2016-01-01

    Background The Systolic Blood Pressure Intervention Trial (SPRINT) is a multicenter, randomized clinical trial of 9,361 participants with hypertension who are ≥ 50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal recruitment strategies and lessons learned during recruitment of the SPRINT cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥ 75 years, women, and minorities. Methods In collaboration with the National Institutes of Health Project Office and SPRINT Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began November 8, 2010 and ended March 15, 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Results Recruitment was scheduled to last 24 months to enroll a target of 9,250 participants; in just over 28 months, the trial enrolled 9,361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by SPRINT staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized /number screened) was 64% (9,361 randomized /14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those age ≥ 75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional clinics were included and inclusion criteria were broadened, keeping event rates

  18. Treatment choices for fevers in children under-five years in a rural Ghanaian district

    Directory of Open Access Journals (Sweden)

    Gyapong Margaret

    2010-06-01

    Full Text Available Abstract Background Health care demand studies help to examine the behaviour of individuals and households during illnesses. Few of existing health care demand studies examine the choice of treatment services for childhood illnesses. Besides, in their analyses, many of the existing studies compare alternative treatment options to a single option, usually self-medication. This study aims at examining the factors that influence the choices that caregivers of children under-five years make regarding treatment of fevers due to malaria and pneumonia in a rural setting. The study also examines how the choice of alternative treatment options compare with each other. Methods The study uses data from a 2006 household socio-economic survey and health and demographic surveillance covering caregivers of 529 children under-five years of age in the Dangme West District and applies a multinomial probit technique to model the choice of treatment services for fevers in under-fives in rural Ghana. Four health care options are considered: self-medication, over-the-counter providers, public providers and private providers. Results The findings indicate that longer travel, waiting and treatment times encourage people to use self-medication and over-the-counter providers compared to public and private providers. Caregivers with health insurance coverage also use care from public providers compared to over-the-counter or private providers. Caregivers with higher incomes use public and private providers over self-medication while higher treatment charges and longer times at public facilities encourage caregivers to resort to private providers. Besides, caregivers of female under-fives use self-care while caregivers of male under-fives use public providers instead of self-care, implying gender disparity in the choice of treatment. Conclusions The results of this study imply that efforts at curbing under-five mortality due to malaria and pneumonia need to take into

  19. Risk factors for malnutrition in under-five children: one year after the Yogyakarta earthquake

    Directory of Open Access Journals (Sweden)

    Neti Nurani

    2011-12-01

    Full Text Available Background Malnutrition in children under the age of five remains a major health problem, since half of mortality cases in this age group involve malnutrition. The 2006 earthquake caused destruction of physical, biological and socio-economic environments, potentially leading to malnutrition in Yogyakarta children. Objective To identify the prevalence and risk factors of malnutrition in Yogyakarta children under five years of age, one year after the 2006 earthquake. Methods We conducted a cross-sectional study among children aged 0 to 60 months in the Bambanglipuro Subdistrict, Bantul Regency, Yogyakarta from September to October 2007. Nutritional status was determined using weight for height Z-scores, according to the WHO 2006 Child Growth Standards. Results Out of 666 subjects, we found severe malnutrition, undernutrition, normal weight, and overweight status in 1.7%, 4.8%, 88.6% and 4.8%, respectively. By multivariate analysis, risk factors for malnutrition were not having been weighed during the previous three months (OR 0.35; 95% CI 0.1 to 0.8 and having acute respiratory infection in the previous two weeks (OR 1.99; 95% CI 1.1 to 3.8 Conclusion One year following the 2006 earthquake, acute respiratory infection in the previous two weeks and unmonitored growth in the previous three months were risk factors for malnutrition in children under five years.

  20. Goiania radiological accident: five years talking with the population

    International Nuclear Information System (INIS)

    Rozental, J.J.

    1993-01-01

    This article presents an overview five years after the Goiania radiological accident. It reviews from a number of important aspects the psychological impact and conflicting opinions, the public hearings and debates and, particularly describes the victims that still have difficulties to understand the accident and its consequences. (B.C.A.). 05 refs

  1. Five-year all-cause mortality rates across five categories of substantiated elder abuse occurring in the community.

    Science.gov (United States)

    Burnett, Jason; Jackson, Shelly L; Sinha, Arup K; Aschenbrenner, Andrew R; Murphy, Kathleen Pace; Xia, Rui; Diamond, Pamela M

    2016-01-01

    Elder abuse increases the likelihood of early mortality, but little is known regarding which types of abuse may be resulting in the greatest mortality risk. This study included N = 1,670 cases of substantiated elder abuse and estimated the 5-year all-cause mortality for five types of elder abuse (caregiver neglect, physical abuse, emotional abuse, financial exploitation, and polyvictimization). Statistically significant differences in 5-year mortality risks were found between abuse types and across gender. Caregiver neglect and financial exploitation had the lowest survival rates, underscoring the value of considering the long-term consequences associated with different forms of abuse. Likewise, mortality differences between genders and abuse types indicate the need to consider this interaction in elder abuse case investigations and responses. Further mortality studies are needed in this population to better understand these patterns and implications for public health and clinical management of community-dwelling elder abuse victims.

  2. Geospatial Health: the first five years

    Directory of Open Access Journals (Sweden)

    Jürg Utzinger

    2011-11-01

    Full Text Available Geospatial Health is an international, peer-reviewed scientific journal produced by the Global Network for Geospatial Health (GnosisGIS. This network was founded in 2000 and the inaugural issue of its official journal was published in November 2006 with the aim to cover all aspects of geographical information system (GIS applications, remote sensing and other spatial analytic tools focusing on human and veterinary health. The University of Naples Federico II is the publisher, producing two issues per year, both as hard copy and an open-access online version. The journal is referenced in major databases, including CABI, ISI Web of Knowledge and PubMed. In 2008, it was assigned its first impact factor (1.47, which has now reached 1.71. Geospatial Health is managed by an editor-in-chief and two associate editors, supported by five regional editors and a 23-member strong editorial board. This overview takes stock of the first five years of publishing: 133 contributions have been published so far, primarily original research (79.7%, followed by reviews (7.5%, announcements (6.0%, editorials and meeting reports (3.0% each and a preface in the first issue. A content analysis of all the original research articles and reviews reveals that three quarters of the publications focus on human health with the remainder dealing with veterinary health. Two thirds of the papers come from Africa, Asia and Europe with similar numbers of contributions from each continent. Studies of more than 35 different diseases, injuries and risk factors have been presented. Malaria and schistosomiasis were identified as the two most important diseases (11.2% each. Almost half the contributions were based on GIS, one third on spatial analysis, often using advanced Bayesian geostatistics (13.8%, and one quarter on remote sensing. The 120 original research articles, reviews and editorials were produced by 505 authors based at institutions and universities in 52 countries

  3. Screenings of lung cancer with low dose spiral CT: results of a three year pilot study and design of the randomised controlled trial Italung-CT

    International Nuclear Information System (INIS)

    Picozzi, Giulia; Paci, Enrico; Lopes Pegna, Andrea

    2005-01-01

    Purpose: To report the results of a three-year observational pilot study of lung cancer screening with low dose computed tomography (CT) and to present the study design of a randomised clinical trial named as Italung CT. Materials and methods: Sixty (47 males and 13 females, mean age 64±4.5 years) heavy smokers (at least 20 packs-year) underwent three low-dose spiral CT screening tests one year apart on a single slice or multislice CT scanner. Indeterminate nodules were managed according to the recommendations of the Early Lung Cancer Action Project. Results: Indeterminate nodules were observed in 33 (55%) of the subjects (60% at the baseline screening test, 24% at the first annual test and 16% at the second annual test). The size of the largest indeterminate nodule was [it

  4. Profiles of five promising industries and apartment dwellings for solar systems trials planning

    Energy Technology Data Exchange (ETDEWEB)

    1891-12-01

    The objective of this study was to identify suitable types of large-scale applications for solar water-heating systems. The factors considered in industrial applications were the amount, type, and cost of energy used for heating water to temperatures <50/sup 0/C. It was found that five industries account for almost one-half of the industrial low-temperautre water-heating requirements. Since oil is the primary source of this energy in Eastern Canada and is soon to be the most costly conventional energy source, large businesses located in Quebec and the Atlantic Provinces were found to be the most promising establishments for solar applications. The report recommends contacting owners in all five industrial sectors to determine their attitudes to solar systems trials and to gather site-specific data. At the same time, the report indicates that apartments, especially those in Eastern Canada, may be more suitable than businesses for large-scale solar water heating. Low-rise apartments use approximately 17 PJ of oil energy for domestic hot water compared to the 11 PJ used by all five industrial subsectors for low-temperature water heating. 4 refs., 5 figs., 100 tabs.

  5. Twenty-five years of post-Bretton Woods experience: some lessons

    Directory of Open Access Journals (Sweden)

    H. ASKARI

    1999-03-01

    Full Text Available In 1971 many academic economists were predicting that the Bretton Woods system of fixed parities would collapse. Some, most notably Milton Friedman, became excited about the possibility of a floating system because the benefits of international capital mobility can only be achieved through the flexibility in the exchange rate. These economists argued that a floating exchange rate system can ensure positive results more than the fixed parities system. Twenty-five years later, however, there is still no consensus on the matter. The author reviews the post-Bretton Woods experience to highlight some policies and approaches that might be helpful for the future.

  6. 47 CFR 22.947 - Five year build-out period.

    Science.gov (United States)

    2010-10-01

    ... authorized in the Gulf of Mexico Exclusive Zone, the licensee of the first cellular system authorized on each channel block in each cellular market is afforded a five year period, beginning on the date the initial authorization for the system is granted, during which it may expand the system within that market. (a) Exclusive...

  7. A National Study of the Prevalence of Autism among Five-Year-Old Children in Iran

    Science.gov (United States)

    Samadi, Sayyed Ali; Mahmoodizadeh, Ameneh; McConkey, Roy

    2012-01-01

    In Iran, more than 1.3 million five-year olds have been screened for autism over three academic years, with the Social Communication Questionnaire (SCQ). The Autism Diagnostic Interview-Revised (ADI-R) is used to confirm a diagnosis of typical autism. The resulting prevalence of 6.26 per 10,000 for typical autism is in line with rates for certain…

  8. Paleolithic nutrition: twenty-five years later.

    Science.gov (United States)

    Konner, Melvin; Eaton, S Boyd

    2010-12-01

    A quarter century has passed since the first publication of the evolutionary discordance hypothesis, according to which departures from the nutrition and activity patterns of our hunter-gatherer ancestors have contributed greatly and in specifically definable ways to the endemic chronic diseases of modern civilization. Refinements of the model have changed it in some respects, but anthropological evidence continues to indicate that ancestral human diets prevalent during our evolution were characterized by much lower levels of refined carbohydrates and sodium, much higher levels of fiber and protein, and comparable levels of fat (primarily unsaturated fat) and cholesterol. Physical activity levels were also much higher than current levels, resulting in higher energy throughput. We said at the outset that such evidence could only suggest testable hypotheses and that recommendations must ultimately rest on more conventional epidemiological, clinical, and laboratory studies. Such studies have multiplied and have supported many aspects of our model, to the extent that in some respects, official recommendations today have targets closer to those prevalent among hunter-gatherers than did comparable recommendations 25 years ago. Furthermore, doubts have been raised about the necessity for very low levels of protein, fat, and cholesterol intake common in official recommendations. Most impressively, randomized controlled trials have begun to confirm the value of hunter-gatherer diets in some high-risk groups, even as compared with routinely recommended diets. Much more research needs to be done, but the past quarter century has proven the interest and heuristic value, if not yet the ultimate validity, of the model.

  9. Comparative clinical effectiveness and cost effectiveness of endovascular strategy v open repair for ruptured abdominal aortic aneurysm: three year results of the IMPROVE randomised trial.

    Science.gov (United States)

    2017-11-14

    Objective  To assess the three year clinical outcomes and cost effectiveness of a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair for patients with suspected ruptured abdominal aortic aneurysm. Design  Randomised controlled trial. Setting  30 vascular centres (29 in UK, one in Canada), 2009-16. Participants  613 eligible patients (480 men) with a clinical diagnosis of ruptured aneurysm, of whom 502 underwent emergency repair for rupture. Interventions  316 patients were randomised to an endovascular strategy (275 with confirmed rupture) and 297 to open repair (261 with confirmed rupture). Main outcome measures  Mortality, with reinterventions after aneurysm repair, quality of life, and hospital costs to three years as secondary measures. Results  The maximum follow-up for mortality was 7.1 years, with two patients in each group lost to follow-up by three years. After similar mortality by 90 days, in the mid-term (three months to three years) there were fewer deaths in the endovascular than the open repair group (hazard ratio 0.57, 95% confidence interval 0.36 to 0.90), leading to lower mortality at three years (48% v 56%), but by seven years mortality was about 60% in each group (hazard ratio 0.92, 0.75 to 1.13). Results for the 502 patients with repaired ruptures were more pronounced: three year mortality was lower in the endovascular strategy group (42% v 54%; odds ratio 0.62, 0.43 to 0.88), but after seven years there was no clear difference between the groups (hazard ratio 0.86, 0.68 to 1.08). Reintervention rates up to three years were not significantly different between the randomised groups (hazard ratio 1.02, 0.79 to 1.32); the initial rapid rate of reinterventions was followed by a much slower mid-term reintervention rate in both groups. The early higher average quality of life in the endovascular strategy versus open repair group, coupled with the lower mortality at three years, led to a

  10. Sentinel node biopsy in breast cancer: five years experience from Denmark

    DEFF Research Database (Denmark)

    Christiansen, Peter; Balslev, E.; Jensen, D.

    2008-01-01

    INTRODUCTION: Danish experience from the first five years with sentinel lymph node biopsy (SLNB) as a routine staging procedure in early breast cancer is reported. METHODS: During the period January 1, 2002 to December 31, 2006, 14 923 patients were diagnosed at Danish breast surgical centers...... certified for the sentinel node method. SLNB was performed in 8 338 patients (55.9%). The fraction increased steadily from 43% in 2002 to 67% in 2006. The median follow-up was 1.7 year (range 0-5.2 years). RESULTS: Patients staged with SLNB were younger, had more often BCS, had smaller tumor size, were more...... often hormone receptor positive, and had lower grade, than patients staged with lymph node dissection (ALND). Blue dye and radio colloid were used in combination in 82%. Lymphoscintigraphy was performed in 61%, and frozen section was performed in 87%. Originally, peritumoral injection of tracer was most...

  11. TVT versus laparoscopic mesh colposuspension: 5-year follow-up results of a randomized clinical trial.

    Science.gov (United States)

    Valpas, A; Ala-Nissilä, S; Tomas, E; Nilsson, C G

    2015-01-01

    Before the introduction of the tension-free vaginal tape (TVT) procedure for the treatment of female stress urinary incontinence, the colposuspension operation was regarded as the "gold standard" procedure. The laparoscopic variant of the colposuspension was introduced as a less invasive operation. The aim of the present trial was to compare the new minimally invasive TVT procedure with laparoscopic mesh colposuspension (LCM). A multicenter randomized clinical trial conducted in six public hospitals in Finland including primary cases of stress incontinence. Objective treatment success criteria were a negative stress test and no retreatment for stress incontinence. Patient satisfaction was assessed by Patients Global Impression of Improvement, a visual analog scale, and the Urinary Incontinence Severity Score. Of 128 randomized patients, 121 underwent the allocated operation. At the 5-year follow-up 77 % in the TVT group and 84 % in the LCM group could be assessed according to the protocol. The objective cure rate was significantly higher in the TVT group (94 %) than in the LCM group (78 %). Subjective treatment satisfaction (completely satisfied with the procedure) was significantly higher in the TVT group (64 %) than in the LCM group (51 %). By per protocol analysis both objective and subjective cure rates were significantly higher in the TVT group than in the LCM group. If cases that were lost to follow-up were regarded as failures, the intension-to-treat analysis found no difference between the groups.

  12. Chief Financial Officer FY 1997 status report and five-year plan

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-10-01

    The Chief Financial Officers Act of 1990 (CFO Act) establishes the legal framework for improved Federal financial management. The Act requires the agency CFO to prepare, and annually revise, a plan to implement the Office of Management and Budget (OMB) Federal Financial Management Status Report and Five-Year Plan. This is the sixth Status Report and Five-Year Plan submission to OMB by the Department of Energy (DOE). Financial management at the Department operates in an environment of Government-wide efforts to improve financial management and implements legislation and administrative provisions which stress the need for change. This report sets forth the Department`s plans for financial management improvements in the coming years. It also highlights several new initiatives completed or currently underway that will significantly improve the overall effectiveness of financial management at the Department of Energy.

  13. Implications of HIV PrEP Trials Results

    Science.gov (United States)

    Anton, Peter; Fletcher, Courtney V.; DeGruttola, Victor; McGowan, Ian; Becker, Stephen; Zwerski, Sheryl; Burns, David

    2011-01-01

    Abstract Six randomized clinical trials have been implemented to examine the efficacy of tenofovir disoproxil fumarate (TDF) and/or TDF/emtricitabine (TDF/FTC) as preexposure prophylaxis for HIV-1 infection (PrEP). Although largely complementary, the six trials have many similar features. As the earliest results become available, an urgent question may arise regarding whether changes should be made in the conduct of the other trials. To consider this in advance, a Consultation on the Implications of HIV Pre-Exposure Prophylaxis (PrEP) Trials Results sponsored by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and the Bill and Melinda Gates Foundation (BMGF) was held on January 29, 2010, at the Natcher Conference Center, NIH, Bethesda, MD. Participants included basic scientists, clinical researchers (including investigators performing the current PrEP trials), and representatives from the U.S. Food and Drug Administration (FDA) and the agencies sponsoring the trials: the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Agency for International Development (USAID), the BMGF, and the U.S. NIH. We report here a summary of the presentations and highlights of salient discussion topics from this workshop. PMID:20969483

  14. Conflicting results between randomized trials and observational studies on the impact of proton pump inhibitors on cardiovascular events when coadministered with dual antiplatelet therapy: systematic review.

    Science.gov (United States)

    Melloni, Chiara; Washam, Jeffrey B; Jones, W Schuyler; Halim, Sharif A; Hasselblad, Victor; Mayer, Stephanie B; Heidenfelder, Brooke L; Dolor, Rowena J

    2015-01-01

    Discordant results have been reported on the effects of concomitant use of proton pump inhibitors (PPIs) and dual antiplatelet therapy (DAPT) for cardiovascular outcomes. We conducted a systematic review comparing the effectiveness and safety of concomitant use of PPIs and DAPT in the postdischarge treatment of unstable angina/non-ST-segment-elevation myocardial infarction patients. We searched for clinical studies in MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews, from 1995 to 2012. Reviewers screened and extracted data, assessed applicability and quality, and graded the strength of evidence. We performed meta-analyses of direct comparisons when outcomes and follow-up periods were comparable. Thirty-five studies were eligible. Five (4 randomized controlled trials and 1 observational) assessed the effect of omeprazole when added to DAPT; the other 30 (observational) assessed the effect of PPIs as a class when compared with no PPIs. Random-effects meta-analyses of the studies assessing PPIs as a class consistently reported higher event rates in patients receiving PPIs for various clinical outcomes at 1 year (composite ischemic end points, all-cause mortality, nonfatal MI, stroke, revascularization, and stent thrombosis). However, the results from randomized controlled trials evaluating omeprazole compared with placebo showed no difference in ischemic outcomes, despite a reduction in upper gastrointestinal bleeding with omeprazole. Large, well-conducted observational studies of PPIs and randomized controlled trials of omeprazole seem to provide conflicting results for the effect of PPIs on cardiovascular outcomes when coadministered with DAPT. Prospective trials that directly compare pharmacodynamic parameters and clinical events among specific PPI agents in patients with unstable angina/non-ST-segment-elevation myocardial infarction treated with DAPT are warranted. © 2015 American Heart Association, Inc.

  15. Energy Balance 4 Kids with Play: Results from a Two-Year Cluster-Randomized Trial.

    Science.gov (United States)

    Madsen, Kristine; Linchey, Jennifer; Gerstein, Dana; Ross, Michelle; Myers, Esther; Brown, Katie; Crawford, Patricia

    2015-08-01

    Identifying sustainable approaches to improving the physical activity (PA) and nutrition environments in schools is an important public health goal. This study examined the impact of Energy Balance for Kids with Play (EB4K with Play), a school-based intervention developed by the Academy of Nutrition and Dietetics Foundation and Playworks, on students' PA, dietary habits and knowledge, and weight status over 2 years. This cluster-randomized, controlled trial took place in four intervention and two control schools over 2 years (n=879; third- to fifth-grade students). PA (fourth and fifth grades only), dietary knowledge and behaviors, school policies, and BMI z-score were assessed at baseline (fall 2011), midpoint (spring 2012), and endpoint (fall 2012 for accelerometers; spring 2013 for all other outcomes). At endpoint, there were no group differences in change in PA or dietary behaviors, although BMI z-score decreased overall by -0.07 (p=0.05). Students' dietary knowledge significantly increased, as did the amount of vegetables schools served. Post-hoc analyses stratified by grade revealed that, relative to control students, fourth-grade intervention students reduced school-day sedentary time by 15 minutes (p=0.023) and third-grade intervention students reduced BMI z-score by -0.2 (0.05; pchildren's dietary knowledge and may improve weight status and decrease sedentary behaviors among younger children. Future iterations should examine programming specific for different age groups.

  16. Five-year workplace wellness intervention in the NHS

    OpenAIRE

    Blake, Holly; Zhou, Dingyuan; Batt, Mark E.

    2013-01-01

    aims:\\ud Poor health and well-being has been observed among NHS staff and has become a key focus in current public health policy. The objective of this study was to deliver and evaluate a five-year employee wellness programme aimed at improving the health and well-being of employees in a large NHS workplace.\\ud method:\\ud A theory-driven multi-level ecological workplace wellness intervention was delivered including health campaigns, provision of facilities and health-promotion activities to e...

  17. [Research on the incidence of decompression sickness in compressed air works. The development of its recent five years' study].

    Science.gov (United States)

    Mano, Y; Shibayama, M; Matsui, Y

    1987-07-01

    Compressed air works have been used as the safest construction work for the basic underground or underwater compressed shield or caisson works in Japan; however, the workers who were exposed to the compressed fields must have put themselves at risk of decompression sickness. Decompression sickness is generally considered to be due to the bubble effects and the bubbles originate from the supersaturated gas dissolved in the blood and other tissues. The standard decompression schedule by the Ministry of Labor has been practically applied at the end of compressed air works, and the laborers decompress slowly from the bottom pressure to the surface according to the schedule. It is difficult to completely prevent the sickness and the average percentage of contracting "bends," using the Japanese standard decompression schedule, is considered to be 0.54%. But previous papers reported higher incidences from 1.42 to 3.3% or more. We have continued an actual investigation on the incidence, and the number of the exposed trials amounted to nearly a hundred thousand. These data were compared between recent five years' group and before. Eventually, it was ascertained that the incidence has been significantly decreased in the recent five years; however, greater care in occupational safety control is still needed.

  18. Clinical course after five years of insulin therapy in patients with type 2 diabetes in Spain: results of the EDIN study.

    Science.gov (United States)

    Rodríguez, Angel; Tofe, Santiago; Reviriego, Jesus

    2014-01-01

    The primary study objective was to assess the proportion of patients with type 2 diabetes and an HbA1c value ≤ 6.5% from the start of insulin therapy to five years later in the outpatient setting in Spain. This was an observational, multicenter, naturalistic study with retrospective collection of clinical data. Investigators were endocrinologists or internal medicine specialists from all over Spain. During standard clinical care, patients started insulin therapy, which was continued for at least 5 years. The clinical records of 405 patients were reviewed. The final analysis set included records from 346 patients. At baseline (start of insulin therapy), 51.2% of patients were female; mean (SD) age was 64.6 (9.0) years; body mass index, 29.8 (4-5) kg/m(2); time since diagnosis, 8.8 (6.8) years; HbA1c, 9.4% (1.5); fasting glucose, 223.7 (55.9) mg/dL; and mean 2-hour postprandial glucose, 293.6 (71.0) mg/dL. When insulin therapy was started, 1.0% of patients had an HbA1c value ≤ 6.5%. At 5 years, 10.3% of patients achieved the HbA1c goal of ≤ 6.5% (mean, 7.72%). All glucose parameters (HbA1c, fasting glucose, and 2-hour postprandial glucose) improved at 5 years as compared to values at the start of insulin therapy. Glucose parameters improved over time in patients with type 2 diabetes in this naturalistic study. However, blood glucose control exceeded the internationally recommended target values. These results therefore suggest that there is still some margin for improvement in outpatient care in Spain. Copyright © 2013 SEEN. Published by Elsevier Espana. All rights reserved.

  19. An audit strategy for time-to-event outcomes measured with error: application to five randomized controlled trials in oncology.

    Science.gov (United States)

    Dodd, Lori E; Korn, Edward L; Freidlin, Boris; Gu, Wenjuan; Abrams, Jeffrey S; Bushnell, William D; Canetta, Renzo; Doroshow, James H; Gray, Robert J; Sridhara, Rajeshwari

    2013-10-01

    Measurement error in time-to-event end points complicates interpretation of treatment effects in clinical trials. Non-differential measurement error is unlikely to produce large bias [1]. When error depends on treatment arm, bias is of greater concern. Blinded-independent central review (BICR) of all images from a trial is commonly undertaken to mitigate differential measurement-error bias that may be present in hazard ratios (HRs) based on local evaluations. Similar BICR and local evaluation HRs may provide reassurance about the treatment effect, but BICR adds considerable time and expense to trials. We describe a BICR audit strategy [2] and apply it to five randomized controlled trials to evaluate its use and to provide practical guidelines. The strategy requires BICR on a subset of study subjects, rather than a complete-case BICR, and makes use of an auxiliary-variable estimator. When the effect size is relatively large, the method provides a substantial reduction in the size of the BICRs. In a trial with 722 participants and a HR of 0.48, an average audit of 28% of the data was needed and always confirmed the treatment effect as assessed by local evaluations. More moderate effect sizes and/or smaller trial sizes required larger proportions of audited images, ranging from 57% to 100% for HRs ranging from 0.55 to 0.77 and sample sizes between 209 and 737. The method is developed for a simple random sample of study subjects. In studies with low event rates, more efficient estimation may result from sampling individuals with events at a higher rate. The proposed strategy can greatly decrease the costs and time associated with BICR, by reducing the number of images undergoing review. The savings will depend on the underlying treatment effect and trial size, with larger treatment effects and larger trials requiring smaller proportions of audited data.

  20. Similar Occurrence of Febrile Episodes Reported in Non-Atopic Children at Three to Five Years of Age after Prebiotics Supplemented Infant Formula.

    Science.gov (United States)

    van Stuijvenberg, Margriet; Stam, José; Grüber, Christoph; Mosca, Fabio; Arslanoglu, Sertac; Chirico, Gaetano; Braegger, Christian P; Riedler, Josef; Boehm, Günther; Sauer, Pieter J J

    2015-01-01

    This is a follow up study of a multicenter randomised placebo-controlled trial in seven centres in five West European countries. The RCT assessed the effect of infant formula supplemented with a mixture of prebiotics (with neutral short-chain and long-chain oligosaccharides and pectin-derived acidic oligosaccharides) during infancy in term-born children (n=1130). In the follow-up study 672 children (60% of the study population) participated: 232 (56%) from the prebiotics group (PG), 243 (58%) from the control group (CG), and 197 (66%) from the non-randomised breast-fed group (BG). The primary outcome was the occurrence of febrile episodes at three to five years of age prospectively documented by the parents: in the PG 1.17 (interquartile range 0.50-2.08) episodes per year versus 1.20 (0.52-2.57) in the CG; and 1.48 (0.65-2.60) in the BG. This specific prebiotics mixture given during infancy in healthy non-atopic subjects does not decrease febrile episodes and therefore seems not to prevent infection between their third and fifth birthday.

  1. External Beam Accelerated Partial-Breast Irradiation Using 32 Gy in 8 Twice-Daily Fractions: 5-Year Results of a Prospective Study

    International Nuclear Information System (INIS)

    Pashtan, Itai M.; Recht, Abram; Ancukiewicz, Marek; Brachtel, Elena; Abi-Raad, Rita F.; D'Alessandro, Helen A.; Levy, Antonin; Wo, Jennifer Y.; Hirsch, Ariel E.; Kachnic, Lisa A.; Goldberg, Saveli; Specht, Michelle; Gadd, Michelle; Smith, Barbara L.; Powell, Simon N.; Taghian, Alphonse G.

    2012-01-01

    Purpose: External beam accelerated partial breast irradiation (APBI) is an increasingly popular technique for treatment of patients with early stage breast cancer following breast-conserving surgery. Here we present 5-year results of a prospective trial. Methods and Materials: From October 2003 through November 2005, 98 evaluable patients with stage I breast cancer were enrolled in the first dose step (32 Gy delivered in 8 twice-daily fractions) of a prospective, multi-institutional, dose escalation clinical trial of 3-dimensional conformal external beam APBI (3D-APBI). Median age was 61 years; median tumor size was 0.8 cm; 89% of tumors were estrogen receptor positive; 10% had a triple-negative phenotype; and 1% had a HER-2-positive subtype. Median follow-up was 71 months (range, 2-88 months; interquartile range, 64-75 months). Results: Five patients developed ipsilateral breast tumor recurrence (IBTR), for a 5-year actuarial IBTR rate of 5% (95% confidence interval [CI], 1%-10%). Three of these cases occurred in patients with triple-negative disease and 2 in non-triple-negative patients, for 5-year actuarial IBTR rates of 33% (95% CI, 0%-57%) and 2% (95% CI, 0%-6%; P<.0001), respectively. On multivariable analysis, triple-negative phenotype was the only predictor of IBTR, with borderline statistical significance after adjusting for tumor grade (P=.0537). Conclusions: Overall outcomes were excellent, particularly for patients with estrogen receptor-positive disease. Patients in this study with triple-negative breast cancer had a significantly higher IBTR rate than patients with other receptor phenotypes when treated with 3D-APBI. Larger, prospective 3D-APBI clinical trials should continue to evaluate the effect of hormone receptor phenotype on IBTR rates.

  2. External Beam Accelerated Partial-Breast Irradiation Using 32 Gy in 8 Twice-Daily Fractions: 5-Year Results of a Prospective Study

    Energy Technology Data Exchange (ETDEWEB)

    Pashtan, Itai M. [Harvard Radiation Oncology Program, Boston, Massachusetts (United States); Recht, Abram [Department of Radiation Oncology, Beth Israel Deaconess Medical Center, Boston, Massachusetts (United States); Ancukiewicz, Marek [Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States); Brachtel, Elena [Department of Pathology, Massachusetts General Hospital, Boston, Massachusetts (United States); Abi-Raad, Rita F. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States); D' Alessandro, Helen A. [Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts (United States); Levy, Antonin; Wo, Jennifer Y. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States); Hirsch, Ariel E. [Department of Radiation Oncology, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts (United States); Kachnic, Lisa A. [Department of Surgery, Massachusetts General Hospital, Boston, Massachusetts (United States); Goldberg, Saveli [Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States); Specht, Michelle; Gadd, Michelle; Smith, Barbara L. [Department of Surgery, Massachusetts General Hospital, Boston, Massachusetts (United States); Powell, Simon N. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States); Taghian, Alphonse G., E-mail: ataghian@partners.org [Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States)

    2012-11-01

    Purpose: External beam accelerated partial breast irradiation (APBI) is an increasingly popular technique for treatment of patients with early stage breast cancer following breast-conserving surgery. Here we present 5-year results of a prospective trial. Methods and Materials: From October 2003 through November 2005, 98 evaluable patients with stage I breast cancer were enrolled in the first dose step (32 Gy delivered in 8 twice-daily fractions) of a prospective, multi-institutional, dose escalation clinical trial of 3-dimensional conformal external beam APBI (3D-APBI). Median age was 61 years; median tumor size was 0.8 cm; 89% of tumors were estrogen receptor positive; 10% had a triple-negative phenotype; and 1% had a HER-2-positive subtype. Median follow-up was 71 months (range, 2-88 months; interquartile range, 64-75 months). Results: Five patients developed ipsilateral breast tumor recurrence (IBTR), for a 5-year actuarial IBTR rate of 5% (95% confidence interval [CI], 1%-10%). Three of these cases occurred in patients with triple-negative disease and 2 in non-triple-negative patients, for 5-year actuarial IBTR rates of 33% (95% CI, 0%-57%) and 2% (95% CI, 0%-6%; P<.0001), respectively. On multivariable analysis, triple-negative phenotype was the only predictor of IBTR, with borderline statistical significance after adjusting for tumor grade (P=.0537). Conclusions: Overall outcomes were excellent, particularly for patients with estrogen receptor-positive disease. Patients in this study with triple-negative breast cancer had a significantly higher IBTR rate than patients with other receptor phenotypes when treated with 3D-APBI. Larger, prospective 3D-APBI clinical trials should continue to evaluate the effect of hormone receptor phenotype on IBTR rates.

  3. Preventing Dental Caries in Children from Birth Through Age Five Years

    Science.gov (United States)

    Understanding Task Force Recommendations Preventing Dental Caries in Children from Birth Through Age Five Years The U.S. Preventive Services Task Force (Task Force) has issued a final recommendation statement ...

  4. Twenty five years of fundamental theory

    International Nuclear Information System (INIS)

    Bell, J.S.

    1980-01-01

    In reviewing the last twenty five years in fundamental physics theory it is stated that there has been no revolution in this field. In the absence of gravitation, Lorentz invariance remains a requirement on fundamental laws. Einstein's theory of gravitation inspires increasing conviction on the astronomical scale. Quantum theory remains the framework for all serious effort in microphysics, and quantum electrodynamics remains the model of a fully articulated microphysical theory, completely successful in its domain. However,a number of ideas have appeared, of great theoretical interest and some phenomenological success, which may well contribute to the next decisive step. Recent work on the following topics is mentioned; gravitational radiation, singularites, black body radiation from black holes, gauge and hidden symmetry in quantum electrodynamics, the renormalization of electromagnetic and weak interaction theory, non-Abelian gauge theories, magnetic monopoles as the most striking example of solitons, and supersymmetry. (UK)

  5. Progress in 11th Five Year and the geneal idea for 12th Five Year of uranium exploration and geological science and technology

    International Nuclear Information System (INIS)

    Zhang Jindai; Jian Xiaofei; Li Youliang; Du Jiannong; Guo Qinggen; Zhang Qiuying

    2011-01-01

    Since the 11th-Five Year, uranium exploration in China has retrieved obviously and some new resources have been identified. More detailed uranium exploration has been carried out in about 1 000 000 km 2 , exploration in large uranium resource bases, old orefields and focusing prospect areas has achieved important progress, several middle-large and extral-large deposits have been discovered, and one super-large deposit was submitted for the first time in China. In the science and technology of uranium exploration, the capability and platform of research has been reinforced, a number of key projects have been carried out such as national uranium potential evaluation, study of 'four types of uranium deposit', research for the enlargement of uranium resource bases, research of application foundation of uranium geology, research on exploratin techniques and method and technological standard. All these projects have obtained fruitful result and significantly raised the creative level in uranium science and technology. In the coming 12th Five Year, uranium exploration will follow the strategy of 'foundation research first with focus on resource base,systematical exploration and integral evaluation second' under the guideline of 'domestic foothold and oversea development' and set up large uranium resource bases, four major geological preosecting programs will be commence in the exploration for large uranium resource base, national uranium survey, regional evaluation of potential uranium resource and science and technology innovation of uranium geology, Ideas of 'Great uranium exploration system' should be set up to widely unite the localized prospecting teams and cooperate with the geologic research organization such as domestic and foreign university and college so as to make corespondent contribution to raise the supporting capability of uranium resources in China. (authors)

  6. Does television viewing predict dietary intake five years later in high school students and young adults?

    Directory of Open Access Journals (Sweden)

    Neumark-Sztainer Dianne

    2009-01-01

    Full Text Available Abstract Background Prior research has found that television viewing is associated with poor diet quality, though little is known about its long-term impact on diet, particularly during adolescence. This study examined the associations between television viewing behavior with dietary intake five years later. Methods Survey data, which included television viewing time and food frequency questionnaires, were analyzed for 564 middle school students (younger cohort and 1366 high school students (older cohort who had complete data available at Time 1 (1998–1999 and five years later at Time 2 (mean age at Time 2, 17.2 ± 0.6 and 20.5 ± 0.8 years, respectively. Regression models examined longitudinal associations between Time 1 television viewing behavior and Time 2 dietary intake adjusting for sociodemographic characteristics, Time 1 dietary intake, and Time 2 total daily energy intake. Results Respondents were categorized as limited television users (2 hours/daily, moderately high television viewers (2–5 hours/daily, and heavy television viewers (≥5 hours/daily. Among the younger cohort, Time 1 heavy television viewers reported lower fruit intake and higher sugar-sweetened beverage consumption than the other two groups. Among the older cohort, watching five or more hours of television per day at Time 1, predicted lower intakes of fruits, vegetables, whole grain and calcium-rich foods, and higher intakes of trans fat, fried foods, fast food menu items, snack products, and sugar-sweetened beverages (products commonly advertised on television five years later. Conclusion Television viewing in middle and high school predicted poorer dietary intake five years later. Adolescents are primary targets of advertising for fast food restaurants, snack foods, and sugar-sweetened beverages, which may influence their food choices. Television viewing, especially during high school, may have long-term effects on eating choices and contribute to poor eating

  7. Development problems were common five years after positive screening for language disorders and, or, autism at 2.5 years of age.

    Science.gov (United States)

    Miniscalco, Carmela; Fernell, Elisabeth; Thompson, Lucy; Sandberg, Eva; Kadesjö, Björn; Gillberg, Christopher

    2018-04-10

    This study identified whether children who had screened positive for either developmental language disorder (DLD) or autism spectrum disorder (ASD) at the age of 2.5 years had neurodevelopmental assessments five years later. Our study cohort were 288 children born from 1 July 2008 to 20 June 2009 who screened positive for DLD and, or, ASD at 2.5 years. Of these, 237 children were referred to, and assessed, at the Paediatric Speech and Language Pathology clinic (n = 176) or the Child Neuropsychiatry Clinic (n = 61) at the Queen Silvia Children's Hospital, Gothenburg, Sweden. Clinical registers covering all relevant outpatient clinics were reviewed five years later with regard to established diagnoses. When the 237 were followed up five years later, 96 (40%) had established neurodevelopmental disorders or problems, often beyond DLD and ASD. Co-existing problems were common in this cohort and multidisciplinary assessments were indicated. The other 60% did not appear in subsequent clinic records. It is likely that this 40% was a minimum rate and that more children will be referred for developmental problems later. Five years after they had been screened positive for DLD and, or autism at 2.5 years, 40% of our cohort had remaining or other developmental problems. ©2018 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

  8. Five Years of Humanitarian Missions in São Tomé and Príncipe

    Directory of Open Access Journals (Sweden)

    Cristina Caroça

    2016-01-01

    We have witnessed a considerable improvement on the children to whom we have adapted prosthetics. Some of them return to school, have friends and became more social. As the result of this work, we conclude that all Humanitarian Missions must be adapted to each country’s needs as we have done over the past five years.

  9. Socio-economic factors predisposing under five-year-old children to ...

    African Journals Online (AJOL)

    Background: Malnutrition is one of the leading causes of morbidity and mortality in children aged five years and below. Risk factors for severe protein energy malnutrition (PEM) have been identified as ignorance, family size, mothers and fathers education, poverty, residence, chronic infections, and congenital defects or ...

  10. Effect of cessation of GH treatment on cognition during transition phase in Prader-Willi syndrome: results of a 2-year crossover GH trial

    Directory of Open Access Journals (Sweden)

    R. J. Kuppens

    2016-11-01

    Full Text Available Abstract Background Patients with Prader-Willi syndrome (PWS have a cognitive impairment. Growth hormone (GH treatment during childhood improves cognitive functioning, while cognition deteriorates in GH-untreated children with PWS. Cessation of GH treatment at attainment of adult height (AH might deteriorate their GH-induced improved cognition, while continuation might benefit them. We, therefore, investigated the effects of placebo versus GH administration on cognition in young adults with PWS who were GH-treated for many years during childhood and had attained AH. Method Two-year, randomized, double-blind, placebo-controlled cross-over study in 25 young adults with PWS. Cross-over intervention with placebo and GH (0.67 mg/m2/day, both during 1 year. Results Total (TIQ, verbal (VIQ and performance IQ (PIQ did not deteriorate during 1 year of placebo, compared to GH treatment (p > 0.322. Young adults with a lower TIQ had significantly more loss of TIQ points during placebo versus GH, in particular VIQ decreased more in those with a lower VIQ. The effect of placebo versus GH on TIQ, VIQ and PIQ was not different for gender or genotype. Conclusions Compared to GH treatment, 1 year of placebo did not deteriorate cognitive functioning of GH-treated young adults with PWS who have attained AH. However, patients with a lower cognitive functioning had more loss in IQ points during placebo versus GH treatment. The reassuring finding that 1 year of placebo does not deteriorate cognitive functioning does, however, not exclude a gradual deterioration of cognitive functioning on the long term. Trial registration ISRCTN24648386 , NTR1038 , Dutch Trial Register, www.trialregister.nl . Registered 16 August 2007.

  11. RMP Guidance for Chemical Distributors - Chapter 3: Five-Year Accident History

    Science.gov (United States)

    A five year accident history must be completed for each covered process, and all accidental release events meeting specified criteria must be reported in the Risk Management Plan (RMP) for that process.

  12. Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya.

    Directory of Open Access Journals (Sweden)

    Craig R Cohen

    Full Text Available To determine if integration of family planning (FP and HIV services led to increased use of more effective contraception (i.e. hormonal and permanent methods, and intrauterine devices and decreased pregnancy rates.Cohort analysis following cluster randomized trial, when the Kenya Ministry of Health led integration of the remaining control (delayed integration sites and oversaw integrated services at the original intervention (early integration sites.Eighteen health facilities in Kenya.Women aged 18-45 receiving care: 5682 encounters at baseline, and 11628 encounters during the fourth quarter of year 2."One-stop shop" approach to integrating FP and HIV services.Use of more effective contraceptive methods and incident pregnancy across two years of follow-up.Following integration of FP and HIV services at the six delayed integration clinics, use of more effective contraception increased from 31.7% to 44.2% of encounters (+12.5%; Prevalence ratio (PR = 1.39 (1.19-1.63. Among the twelve early integration sites, the proportion of encounters at which women used more effective contraceptive methods was sustained from the end of the first to the second year of follow-up (37.5% vs. 37.0%. Pregnancy incidence including all 18 integrated sites in year two declined in comparison to the control arm in year one (rate ratio: 0.72; 95% CI 0.60-0.87.Integration of FP services into HIV clinics led to a sustained increase in the use of more effective contraceptives and decrease in pregnancy incidence 24 months following implementation of the integrated service model.ClinicalTrials.gov NCT01001507.

  13. Daya Bay Nuclear Power Station five-year business plan and operating results

    International Nuclear Information System (INIS)

    Zhang Shanming

    2000-01-01

    Guangdong Nuclear Power Joint Venture Company, Ltd. first 5-Year Business Plan (hereinafter referred to as 5-Year Business Plan) serves as guidance of both the operations and management of the company. Continuous performance improvement of the nuclear power station has been achieved through the fulfillment of goals and improvement plan defined by the 5-Year Business Plan, and through standard and systematic management. Daya Bay Nuclear Power Station (GNPS) has made great contributions to sustainable economic developments of both Guangdong and Hong Kong since its commercial operation in 1994. As of the end of 1999, the cumulative off-take electricity generated by GNPS had reached 69.9 billion kWh. Of the WANO indicators universally applied by nuclear power industry throughout the world, 6 indicators of Daya Bay performance entered the world top quartile while 9 the medium level

  14. Five year results of an international proficiency testing programme for measurement of antifungal drug concentrations

    NARCIS (Netherlands)

    Lempers, V.J.C.; Alffenaar, J.W.C.; Touw, D.J.; Burger, D.M.; Uges, D.R.A.; Aarnoutse, R.E.; Brüggemann, R.J.M.

    2014-01-01

    OBJECTIVES: Since 2007 the Dutch Association for Quality Assessment in Therapeutic Drug Monitoring (KKGT) has organized an international interlaboratory proficiency testing (PT) programme for measurement of antifungal drugs in plasma. We describe the 5 year results of the laboratories' performance.

  15. Patients' knowledge of Diabetes five years after the end of an educational program

    Directory of Open Access Journals (Sweden)

    Izabel Alves das Chagas

    2013-10-01

    Full Text Available We present a cross-sectional study that aims to describe the sociodemographic and clinical conditions of individuals with diabetes mellitus and to analyze their knowledge of treatment five years after the end of an educational program in which they took part. In 2010, 40 individuals who had participated in a diabetes educational program for 12 months in 2005 at a primary care service were interviewed. A form was used for data collection that included their knowledge of the notion, physiopathology, and treatment of the disease; exercise; nutrition; foot care; self-monitoring of capillary blood glucose at home; hypoglycemia; chronic complications; special situations; and family support. The results showed that the volunteers incorporated the information about the notion, physiopathology, and treatment of the disease; exercise; foot care; self-monitoring; care associated with hypoglycemia; chronic complications; and special situations. In contrast, nutrition and family support require further reinforcement. It is concluded that five years after the end of the educational program, the participants kept most of the information provided.

  16. 10 years of denosumab treatment in postmenopausal women with osteoporosis: results from the phase 3 randomised FREEDOM trial and open-label extension.

    Science.gov (United States)

    Bone, Henry G; Wagman, Rachel B; Brandi, Maria L; Brown, Jacques P; Chapurlat, Roland; Cummings, Steven R; Czerwiński, Edward; Fahrleitner-Pammer, Astrid; Kendler, David L; Lippuner, Kurt; Reginster, Jean-Yves; Roux, Christian; Malouf, Jorge; Bradley, Michelle N; Daizadeh, Nadia S; Wang, Andrea; Dakin, Paula; Pannacciulli, Nicola; Dempster, David W; Papapoulos, Socrates

    2017-07-01

    Long-term safety and efficacy of osteoporosis treatment are important because of the chronic nature of the disease. We aimed to assess the long-term safety and efficacy of denosumab, which is widely used for the treatment of postmenopausal women with osteoporosis. In the multicentre, randomised, double-blind, placebo-controlled, phase 3 FREEDOM trial, postmenopausal women aged 60-90 years with osteoporosis were enrolled in 214 centres in North America, Europe, Latin America, and Australasia and were randomly assigned (1:1) to receive 60 mg subcutaneous denosumab or placebo every 6 months for 3 years. All participants who completed the FREEDOM trial without discontinuing treatment or missing more than one dose of investigational product were eligible to enrol in the open-label, 7-year extension, in which all participants received denosumab. The data represent up to 10 years of denosumab exposure for women who received 3 years of denosumab in FREEDOM and continued in the extension (long-term group), and up to 7 years for women who received 3 years of placebo and transitioned to denosumab in the extension (crossover group). The primary outcome was safety monitoring, comprising assessments of adverse event incidence and serious adverse event incidence, changes in safety laboratory analytes (ie, serum chemistry and haematology), and participant incidence of denosumab antibody formation. Secondary outcomes included new vertebral, hip, and non-vertebral fractures as well as bone mineral density (BMD) at the lumbar spine, total hip, femoral neck, and one-third radius. Analyses were done according to the randomised FREEDOM treatment assignments. All participants who received at least one dose of investigational product in FREEDOM or the extension were included in the combined safety analyses. All participants who enrolled in the extension with observed data were included in the efficacy analyses. The FREEDOM trial (NCT00089791) and its extension (NCT00523341) are both

  17. Adherence to vaccination guidelines post splenectomy: A five year follow up study.

    Science.gov (United States)

    Boam, Tristan; Sellars, Peter; Isherwood, John; Hollobone, Chloe; Pollard, Cristina; Lloyd, David M; Dennison, Ashley R; Garcea, Giuseppe

    Following a splenectomy patients are at increased risk of significant infections. In its most severe form, overwhelming post-splenectomy infection (OPSI) has a mortality rate of up to 80%. In this study we aim to establish the adherence to vaccination and antibiotic national guidelines in splenectomised patients. A retrospective study of 100 patients who underwent splenectomy (21 emergency, 79 elective), in two teaching hospitals was undertaken over a five-year period. Patients were followed up for five years. Hospital and GP records were reviewed for adherence to pre, intra and postoperative vaccination, thromboprophylaxis and antibiotic guidance. Eighty-six eligible patients (91.5%) received their Haemophilus influenzae B, meningococcal C and pneumococcus vaccinations peri-operatively. Eighty-one (86%) received post-operative antibiotics. Ninety-nine percent of patients received thromboprophylaxis treatment. Eighty-nine (95%) were treated with long-term antibiotic prophylaxis. Only 20 patients (23%) had an emergency supply of antibiotics. Ninety-five percent of patients were administered an annual influenza vaccination and 84% of eligible patients received a five-year pneumococcal booster vaccination. Improvement in the management of this patient cohort can be achieved by a multidisciplinary approach involving adherence to national guidelines, standardised trust protocols, patient information leaflets and advice detailing risk of infection, standardised GP letters and a splenectomy register to monitor and manage this vulnerable group of patients. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  18. System of optimization computations of five year plans in the coal industry. [USSR

    Energy Technology Data Exchange (ETDEWEB)

    Goyzman, E I; Korenev, V G

    1980-01-01

    A system of optimization computations of five year plans is set forth which was developed over a number of years at the Central Scientific Research Institute of Economics and Scientific-Technical Information of the Coal Industry. Basic principles of design and methodological approaches are given which were used in development of the systemas well as levels of administration and information links between them. The report analyzes the characteristics of problems of planning which arise at different stages of formation of the five year plans and discusses possibilities of taking into account these characteristics in optimized models. Economic formulations of problems of optimization of five year plans are given as applied to two levels of administration: at the branch level and at the level of production associations. Economic-mathematical models of optimization of five year plans are developed for each of the levels and their characteristic features described. The primary methodological principles, on the basis of which optimization models were developed are examined. An economic-mathematical model with continuous variables was developed for the branch level of planning. Volumes of recovery according to a group of shafts in the stage of normal operation (stable group) of each production enterprise are adopted as model variables. A system of limitations which includes limitations on volumes and distinguishable resources is formulated. The minimum of operating expenses, minimum of capital investments and maximum of recovery volumes for the planned period can be used as the optimization criteria. An economic-mathematical model which uses integral variable was developed for the production association level.

  19. Gender identity disorder in a five-year-old boy.

    OpenAIRE

    Herman, S. P.

    1983-01-01

    Markedly effeminate behavior in a young boy is a source of concern and confusion for parents, teachers, and the child. It also represents a therapeutic dilemma for the child psychiatrist. The case of a five-year-old boy with gender identity disorder of childhood is presented and the literature on hypotheses of etiology, treatment, and long-term follow-up is reviewed. The ethical and philosophical questions posed by such a case are discussed.

  20. Publication Trend of Clinical Trials with Negative Results Funded by Pharmaceutical Industries for the 2007-2012 Period

    Directory of Open Access Journals (Sweden)

    Evert A. Jiménez-Cotes

    2015-01-01

    Full Text Available Abstract: Objective: To evaluate the results of clinical trials financed by the pharmaceutical industries during the period 2007-2012 in a general medical journal. Materials and methods: We performed an observational cross sectional study where originals clinical trials financed by the pharmaceutical industry published between 2007 and 2012 in the journal The New England Journal of Medicine (http://www.nejm.org were reviewed. Trend Chi2 test was used to evaluate the results of studies over the years. A database was created with different variables, identifying the number of publications and the period of greater publishing negatives studies, as well as the medical specialty and pharmaceutical industry funding. Results: 321 clinical trials were analyzed. The Odds Ratio was calculated for each year evaluated, finding a Chi2 of linear trend in negatives studies of 2.91 with value p 0.08 and positive studies of 1.16 with value p 0.28. It was found that in the period 2007-2009 123 studies were published, 40 % of which presented negative results; unlike the 2010-2012 period in which 198 clinical trials where published, 142 of them, showed positive results, OR 1.68, 95 % CI (1.02-2.78 value p 0.03. The highest figures of negative results were published in 2007: 44.7 %. Conclusions: A progressive decrease in the number of publications with annual general negative results has been observed. A statistically significant difference in the publication of negative studies per year was not found between the periods 2007-2012. The medical specialty that showed the largest number of total and negative publications in both periods was cardiology. The pharmaceutical industry that sponsored most total clinical trials with negative results in both periods did so through Merck, Glaxo SmithKline, and Sanofi-Aventis. 50% of neurology publications showed negative results.

  1. Five-year quality of life assessment after carbon ion radiotherapy for prostate cancer

    International Nuclear Information System (INIS)

    Maruyama, Katsuya; Tsuji, Hiroshi; Nomiya, Takuma; Katoh, Hiroyuki; Ishikawa, Hitoshi; Kamada, Tadashi; Wakatsuki, Masaru; Akakura, Koichiro; Shimazaki, Jun; Aoyama, Hidefumi; Tsujii, Hirohiko

    2017-01-01

    The aim of this study was to prospectively assess 5-year health-related quality of life (HRQOL) of patients treated with carbon ion radiotherapy (C-ion RT) for clinically localized prostate cancer. A total of 417 patients received carbon ion radiotherapy at a total dose of 63–66 Gray-equivalents (GyE) in 20 fractions over 5 weeks, and neoadjuvant and adjuvant androgen deprivation therapy (ADT) were administered for intermediate and high-risk patients. A HRQOL assessment was performed at five time points (immediately before the initiation of C-ion RT, immediately after, and at 12, 36 and 60 months after completion of C-ion RT) using Functional Assessment of Cancer Therapy (FACT) questionnaires. FACT-G and FACT-P scores were significantly decreased; however, the absolute change after 60 months was minimal. The transient decreases in the Trial Outcome Index (TOI) score returned to their baseline levels. Use of ADT, presence of adverse events, and biochemical failure were related to lower scores. Scores of subdomains of FACT instruments indicated characteristic changes. The pattern of HRQOL change after C-ion RT was similar to that of other modalities. Further controlled studies focusing on a HRQOL in patients with prostate cancer are warranted.

  2. Forty-five year follow-up after uninephrectomy.

    Science.gov (United States)

    Narkun-Burgess, D M; Nolan, C R; Norman, J E; Page, W F; Miller, P L; Meyer, T W

    1993-05-01

    This study examined the consequences of nephrectomy in United States Army personnel who lost a kidney due to trauma during World War II (WWII). Records of 62 servicemen who underwent nephrectomy at an average age of 25 years were obtained. Mortality was compared with that of WWII servicemen of the same age. Medical records of 28 deceased subjects were reviewed for evidence of kidney disease. Medical histories were obtained and blood pressure and kidney function were assessed in 28 living subjects. Two subjects could not be located, and four subjects declined to participate. Mortality at 45 years was not increased in nephrectomized subjects. Kidney disease present in six of 28 deceased subjects was attributable to causes other than prior nephrectomy. Glomerular sclerosis was not increased in 10 subjects who had autopsy examinations. The prevalence of hypertension was not increased in living subjects. Five of 28 living subjects had abnormal renal function manifested by proteinuria greater than 250 mg/day in four cases (range: 377 to 535 mg/day) and serum creatinine levels greater than 1.5 mg/dl in three cases (range: 1.7 to 1.9 mg/dl). Conditions other than nephrectomy could have contributed to impairment of renal function in each of these subjects. These findings suggest that uninephrectomy in young adults has few major adverse consequences over 45 years.

  3. Characterization of automotive shredder residues before and five years after landfill disposal

    Directory of Open Access Journals (Sweden)

    Lucian Ionel Cioca

    2015-04-01

    Full Text Available The paper illustrates the results of an extensive analytical characterization study of automotive shredder residues (ASR, also known as "fluff”. The analyses concerned material fractions and their content, with special reference to heavy metals (e.g. Cd, Cr, Hg, Pb, Cu and arsenic. Elution tests on the original materials were also conducted. Moreover, chemical concentrations of ASR samples after about five years' landfill residence was assessed, in order to verify possible changes resulting from both in-situ leaching and organic matter degradation phenomena. Results show that lead seems to be the most critical element in view of possible ASR acceptance in non-hazardous waste landfills because of its high concentration in raw waste and, especially, of its proven leachability characteristics.

  4. Burden of trachoma in five counties of Eastern Equatoria state, South Sudan: Results from population-based surveys.

    Directory of Open Access Journals (Sweden)

    Angelia M Sanders

    2017-06-01

    Full Text Available In order to decrease the prevalence of trachoma within the country, the Republic of South Sudan has implemented components of the SAFE strategy in various counties since 2001. Five counties in Eastern Equatoria state were surveyed in order to monitor progress of programmatic interventions and determine if additional rounds of Mass Drug Administration with azithromycin were needed.Five counties (Budi, Lafon, Kapoeta East, Kapoeta South and Kapoeta North were surveyed from April to October 2015. A cross-sectional, multi-stage, cluster-random sampling was used. All present, consenting residents of selected households were examined for all clinical signs of trachoma using the World Health Organization (WHO simplified grading system. 14,462 individuals from 3,446 households were surveyed. The prevalence of trachomatous inflammation-follicular (TF in children ages one to nine years ranged from 17.4% (95% Confidence Interval (CI: 11.4%, 25.6% in Budi county to 47.6%, (95% CI: 42.3%, 53.0% in Kapoeta East county. Trachomatous trichiasis (TT was also highly prevalent in those 15 years and older, ranging between 2.6% (95% CI: 1.6%, 4.0% in Kapoeta South to 3.9% (95% CI: 2.4%, 6.1% in Lafon. The presence of water and sanitation were low in all five counties, including two counties which had a complete absence of latrines in all surveyed clusters.To our knowledge, these were the first trachoma surveys conducted in the Republic of South Sudan since their independence in 2011. The results show that despite years of interventions, four of the five surveyed counties require a minimum of five additional years of SAFE strategy implementation, with the fifth requiring at minimum three more years.

  5. Fukushima five years after, a return to the abnormal

    International Nuclear Information System (INIS)

    Boilley, David

    2016-02-01

    After a synthetic presentation of the study which discusses how different issues have been and are still addressed in Fukushima (evacuated populations, protection against radiations, food contamination, future of evacuated lands, reluctance of inhabitants to come back), this report outlines that radioactive releases are still going on (discussion of source terms, continuing leakages, impact on sea, practices resulting in significant releases of radioactive dusts, a still threatening Fukushima plant). The author then addresses issues related to radioactive contamination and evacuation (evacuation sequence, number of displaced persons, situation after 5 years), discusses the reviewing of levels of protection after a nuclear accident (principles of radiation protection, evacuation policy, protection values and operational values, limits for food contamination). He proposes an assessment of food contamination five years after the accident (initial mistakes in food control, extended food controls, internal exposure of consumers, threats on some activities due to production restrictions), and comments the restoration of contaminated territories (restoring policy, limited effects of decontamination, production of a large quantity of wastes which are not well maintained nor secure). He finally comments the issue of population come-back (government decisions, reluctance of inhabitants, depopulation and ageing of contaminated areas, case of human right violation, suffering of elderly people)

  6. Prone Breast Intensity Modulated Radiation Therapy: 5-Year Results

    International Nuclear Information System (INIS)

    Osa, Etin-Osa O.; DeWyngaert, Keith; Roses, Daniel; Speyer, James; Guth, Amber; Axelrod, Deborah; Fenton Kerimian, Maria; Goldberg, Judith D.; Formenti, Silvia C.

    2014-01-01

    Purpose: To report the 5-year results of a technique of prone breast radiation therapy delivered by a regimen of accelerated intensity modulated radiation therapy with a concurrent boost to the tumor bed. Methods and Materials: Between 2003 and 2006, 404 patients with stage I-II breast cancer were prospectively enrolled into 2 consecutive protocols, institutional trials 03-30 and 05-181, that used the same regimen of 40.5 Gy/15 fractions delivered to the index breast over 3 weeks, with a concomitant daily boost to the tumor bed of 0.5 Gy (total dose 48 Gy). All patients were treated after segmental mastectomy and had negative margins and nodal assessment. Patients were set up prone: only if lung or heart volumes were in the field was a supine setup attempted and chosen if found to better spare these organs. Results: Ninety-two percent of patients were treated prone, 8% supine. Seventy-two percent had stage I, 28% stage II invasive breast cancer. In-field lung volume ranged from 0 to 228.27 cm 3 , mean 19.65 cm 3 . In-field heart volume for left breast cancer patients ranged from 0 to 21.24 cm 3 , mean 1.59 cm 3 . There was no heart in the field for right breast cancer patients. At a median follow-up of 5 years, the 5-year cumulative incidence of isolated ipsilateral breast tumor recurrence was 0.82% (95% confidence interval [CI] 0.65%-1.04%). The 5-year cumulative incidence of regional recurrence was 0.53% (95% CI 0.41%-0.69%), and the 5-year overall cumulative death rate was 1.28% (95% CI 0.48%-3.38%). Eighty-two percent (95% CI 77%-85%) of patients judged their final cosmetic result as excellent/good. Conclusions: Prone accelerated intensity modulated radiation therapy with a concomitant boost results in excellent local control and optimal sparing of heart and lung, with good cosmesis. Radiation Therapy Oncology Group protocol 1005, a phase 3, multi-institutional, randomized trial is ongoing and is evaluating the equivalence of a similar dose and fractionation

  7. Prone Breast Intensity Modulated Radiation Therapy: 5-Year Results

    Energy Technology Data Exchange (ETDEWEB)

    Osa, Etin-Osa O.; DeWyngaert, Keith [Department of Radiation Oncology, New York University School of Medicine, New York, New York (United States); Roses, Daniel [Department of Surgery, New York University School of Medicine, New York, New York (United States); Speyer, James [Department of Medical Oncology, New York University School of Medicine, New York, New York (United States); Guth, Amber; Axelrod, Deborah [Department of Surgery, New York University School of Medicine, New York, New York (United States); Fenton Kerimian, Maria [Department of Radiation Oncology, New York University School of Medicine, New York, New York (United States); Goldberg, Judith D. [Department of Population Health, New York University School of Medicine, New York, New York (United States); Formenti, Silvia C., E-mail: Silvia.formenti@nyumc.org [Department of Radiation Oncology, New York University School of Medicine, New York, New York (United States)

    2014-07-15

    Purpose: To report the 5-year results of a technique of prone breast radiation therapy delivered by a regimen of accelerated intensity modulated radiation therapy with a concurrent boost to the tumor bed. Methods and Materials: Between 2003 and 2006, 404 patients with stage I-II breast cancer were prospectively enrolled into 2 consecutive protocols, institutional trials 03-30 and 05-181, that used the same regimen of 40.5 Gy/15 fractions delivered to the index breast over 3 weeks, with a concomitant daily boost to the tumor bed of 0.5 Gy (total dose 48 Gy). All patients were treated after segmental mastectomy and had negative margins and nodal assessment. Patients were set up prone: only if lung or heart volumes were in the field was a supine setup attempted and chosen if found to better spare these organs. Results: Ninety-two percent of patients were treated prone, 8% supine. Seventy-two percent had stage I, 28% stage II invasive breast cancer. In-field lung volume ranged from 0 to 228.27 cm{sup 3}, mean 19.65 cm{sup 3}. In-field heart volume for left breast cancer patients ranged from 0 to 21.24 cm{sup 3}, mean 1.59 cm{sup 3}. There was no heart in the field for right breast cancer patients. At a median follow-up of 5 years, the 5-year cumulative incidence of isolated ipsilateral breast tumor recurrence was 0.82% (95% confidence interval [CI] 0.65%-1.04%). The 5-year cumulative incidence of regional recurrence was 0.53% (95% CI 0.41%-0.69%), and the 5-year overall cumulative death rate was 1.28% (95% CI 0.48%-3.38%). Eighty-two percent (95% CI 77%-85%) of patients judged their final cosmetic result as excellent/good. Conclusions: Prone accelerated intensity modulated radiation therapy with a concomitant boost results in excellent local control and optimal sparing of heart and lung, with good cosmesis. Radiation Therapy Oncology Group protocol 1005, a phase 3, multi-institutional, randomized trial is ongoing and is evaluating the equivalence of a similar dose and

  8. Nutritional profile in children under five years of Afro-descendant communities in Paraguay

    Directory of Open Access Journals (Sweden)

    Susana Sánchez-Bernal

    2015-12-01

    Full Text Available Background: In Paraguay, little is known about the Afro-descendant population. It is important to know about their nutritional status, mainly in childhood, to guide appropriate action. Objective: To determine the nutritional profile of children under five years from the African descendants’ communities in Paraguay and its associated factors. Material and methods: A cross-sectional and observational design with analytical component was developed. It involved healthy male and female children under five years old, with at least one African descendant as immediate family. Dietary habits and nutritional status (WHO criteria were assessed. WHO Anthro and SPSS 16.0 software were used. Results: 150 children were included. The median of age was 26.9 months (1.2-59.9 m, and 50.7% were males. The median maternal age was 28.3 years (16-49 years. Children with Exclusive Breast Feeding (EBF, n=119 had a mean duration of 3.5±1.8 months (1-7m. 26.9% were exclusively breastfed during six months. The starting of complementary feeding was on average 5.2 months. The underweight prevalence (UW, zP/E 0.05. Children with UW had a lower average of age of onset of complementary feeding (1.7 vs 4.9 months, p˂0.0001 compare with their pairs without malnutrition. Conclusion: Chronic malnutrition was the most prevalent chronic disease affecting over 1 in 10 children. Early initiation of complementary feeding could be a risk factor for malnutrition.

  9. Hyperfunctioning thyroid cancer: a five-year follow-up.

    Science.gov (United States)

    Azevedo, Monalisa Ferreira; Casulari, Luiz Augusto

    2010-02-01

    Differentiated thyroid cancer rarely occurs in association with hyperfunctioning nodules. We describe a case of a 47-year-old woman who developed symptoms of hyperthyroidism associated with a palpable thyroid nodule. Thyroid scintigraphy showed an autonomous nodule, and fine-needle aspiration biopsy was suggestive of papillary carcinoma. Laboratorial findings were consistent with the diagnosis of hyperthyroidism. The patient underwent thyroidectomy and a papillary carcinoma of 3.0 x 3.0 x 2.0 cm, follicular variant, was described by histological examination. The surrounding thyroid tissue was normal. Postoperatively, the patient received 100 mCi of (131)I, and whole body scans detected only residual uptake. No evidence of metastasis was detected during five years of follow-up. Hot thyroid nodules rarely harbor malignancies, and this case illustrated that, when a carcinoma occurs the prognosis seems to be very good with no evidence of metastatic dissemination during a long-term follow-up.

  10. Infectious Diseases of Poverty, the first five years.

    Science.gov (United States)

    Wang, Wei; Chen, Jin; Sheng, Hui-Feng; Wang, Na-Na; Yang, Pin; Zhou, Xiao-Nong; Bergquist, Robert

    2017-05-04

    Although the focus in the area of health research may be shifting from infectious to non-communicable diseases, the infectious diseases of poverty remain a major burden of disease of global health concern. A global platform to communicate and share the research on these diseases is needed to facilitate the translation of knowledge into effective approaches and tools for their elimination. Based on the "One health, One world" mission, a new, open-access journal, Infectious Diseases of Poverty (IDP), was launched by BioMed Central in partnership with the National Institute of Parasitic Diseases (NIPD), Chinese Center for Disease Control and Prevention (China CDC) on October 25, 2012. Its aim is to identify and assess research and information gaps that hinder progress towards new interventions for a particular public health problem in the developing world. From the inaugural IDP issue of October 25, 2012, a total of 256 manuscripts have been published over the following five years. Apart from a small number of editorials, opinions, commentaries and letters to the editor, the predominant types of publications are research articles (69.5%) and scoping reviews (21.5%). A total of 1 081 contributing authors divided between 323 affiliations across 68 countries, territories and regions produced these 256 publications. The journal is indexed in major international biomedical databases, including Web of Science, PubMed, Scopus and Embase. In 2015, it was assigned its first impact factor (4.11), which is now 2.13. During the past five years, IDP has received manuscripts from 90 countries, territories and regions across six continents with an annual acceptance rate of all contributions maintained at less than 40%. Content analysis shows that neglected tropical diseases (NTDs), followed by the "Big Three" (HIV/AIDS, malaria and tuberculosis) and infectious diseases in general comprise 88% of all publications. In addition, a series of 10 thematic issues, covering 118 publications

  11. [Maraviroc: clinical trials results].

    Science.gov (United States)

    Chidiac, C; Katlama, C; Yeni, P

    2008-03-01

    Just over a decade after identification of chemokine receptors CCR5 and CXCR4 as coreceptors for HIV, maraviroc (Celsentri), the first CCR5 antagonist, has recently obtained its Marketing Authorization in the United States and Europe, for treatment of treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable. CCR5 antagonists, after fusion inhibitor enfuvirtide available since 2003, also belong to entry inhibitors. These molecules, unlike previous antiretrovirals, do not target the virus but its target cell by blocking viral penetration. Maraviroc has shown its clinical efficacy in patients failing other antiretroviral classes. Its safety profile was similar to placebo in two large phase III trials. However, careful assessment of both hepatic and immunologic safety of this new therapeutic class is needed. Viral tropism testing has to be investigated before using maraviroc in the clinic, because CCR5 antagonists are not active against CXCR4 viruses. For the moment indicated for the treatment-experienced patient population, maraviroc could in the future benefit to other types of patients, depending on ongoing trials results.

  12. A mixed methods study to assess the effectiveness of food-based interventions to prevent stunting among children under-five years in Districts Thatta and Sujawal, Sindh Province, Pakistan: study protocol

    Directory of Open Access Journals (Sweden)

    Sumra Kureishy

    2017-01-01

    Full Text Available Abstract Background Maternal and child malnutrition is widely prevalent in low and middle income countries. In Pakistan, widespread food insecurity and malnutrition are the main contributors to poor health, low survival rates and the loss of human capital development. The nutritional status trends among children exhibit a continuous deteriorating with rates of malnutrition exceeding the WHO critical threshold. With the high prevalence of maternal and child malnutrition, it is important to identify effective preventative approaches, especially for reducing stunting in children under-five years of age. The primary aim of this study is to assess the effectiveness of food-based interventions to prevent stunting in children under-five years. Methods A mixed methods study design will be conducted to evaluate the effectiveness of food-based interventions to prevent stunting among children under-five years in districts Thatta and Sujawal, Sindh Province, Pakistan. The study will include cross sectional surveys, a community-based cluster randomized controlled trial and a process evaluation. The study participants will be pregnant women, lactating mothers and children under-five years. The cross-sectional surveys will be conducted with 7360 study participants at baseline and endline. For the randomized control trial, 5000 participants will be recruited and followed monthly for compliance of food-based supplements, dietary diversity, pregnancy outcomes, and maternal and child morbidity and mortality. Anthropometric measurements and hemoglobin levels will be measured at baseline, quarterly and at endline. The interventions will consist of locally produced lipid-based nutrient supplement (Wawamum for children 6–23 months, micronutrient powders for children 24–59 months, and wheat soya blends for pregnant and lactating mothers. Government lady health workers will deliver interventions to participants. The effectiveness of the project will be measured in

  13. High Prevalence and Incidence of Diabetic Peripheral Neuropathy in Children and Adolescents With Type 1 Diabetes Mellitus: Results From a Five-Year Prospective Cohort Study.

    Science.gov (United States)

    Walter-Höliner, Isabella; Barbarini, Daniela Seick; Lütschg, Jürg; Blassnig-Ezeh, Anya; Zanier, Ulrike; Saely, Christoph H; Simma, Burkhard

    2018-03-01

    In this prospective cohort study, we investigated the prevalence of diabetic peripheral neuropathy at baseline and after five years of follow-up in children and adolescents with type 1 diabetes mellitus using both measurements of nerve conduction velocity and clinical neurological examination. A total of 38 patients who underwent insulin pump or intensive insulin therapy were included. The subjects averaged 12.6 ± 2.4 years of age and their diabetes duration averaged 5.6 ± 3.2 years. All patients underwent a detailed physical, neurological, and electrophysiological examination, as well as laboratory testing at their annual checkup. At baseline, the prevalence of diabetic peripheral neuropathy diagnosed using neurological examination was 13.2%, whereas nerve conduction velocity testing revealed diabetic peripheral neuropathy in 31.6%, highlighting a high prevalence of subclinical diabetic peripheral neuropathy. During follow-up, there was a strong increase in the prevalence of clinically diagnosed diabetic peripheral neuropathy, which reached 34.2% (P = 0.039) after five years; the proportion of patients with subclinical diabetic peripheral neuropathy even reached 63.2% (P = 0.002). The most significant changes in electrophysiological parameters were observed in the tibial sensory nerve (P = 0.001). The prevalence of diabetic peripheral neuropathy in children and adolescents with type 1 diabetes mellitus was high, and there was a rapid increase in the prevalence of diabetic peripheral neuropathy during a five-year follow-up interval. Importantly, our data show that a mere clinical evaluation is not sensitive enough to diagnose diabetic peripheral neuropathy in these patients. Nerve conduction velocity measurement, which is regarded as the gold standard for the assessment of diabetic peripheral neuropathy, should be applied more broadly. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Twenty-five year outcome of sequential abdominopelvic radiotherapy and alkylating agent chemotherapy for ovarian carcinoma

    International Nuclear Information System (INIS)

    Bellairs, Ellen E.; Twiggs, Leo B.; Potish, Roger A.

    1997-01-01

    Purpose: A prospective study of sequential surgery, abdominopelvic radiotherapy and single agent alkylating chemotherapy was conducted to evaluate survival and toxicity in the management of ovarian carcinoma. Methods: From 1970-1976, 95 women with stage I-III epithelial ovarian carcinoma were scheduled to receive postoperative radiotherapy consisting of 20.0 Gy to the whole abdomen (1.0 Gy/day), a 29.75 Gy pelvic boost (1.75 Gy/day) and 10 subsequent courses of Melphalan (1 mg/kg/course). Endpoints were overall survival, disease-free survival(DFS), and acute and chronic toxicity. Results: The evaluable 94 patients included 19 stage I, 25 stage II, and 50 stage III. Of the latter, 21 had no palpable disease postoperatively (IIIN) and 29 had postoperative palpable disease (IIIP). Overall survival at 5, 10, 15 and 20 years was 42%, 30%, 23% and 22%. DFS for the entire group was 54% at 5 years and remained 50% from 10 to 25 years. All but two recurrences were noted within the first 27 months. No recurrence or treatment-related deaths occurred after 8 years. After 10 years, the survival of the study group became parallel to the general population. Prognostic factors were only related to stage (p<.001) and the presence of postoperative palpable disease(p<.001). DFS at 25 years was 95 % for stage I, 71% at 5 years and 66% from 10 to 25 years for stage II, and 17% at 5 years and 11% thereafter for stage III patients(p<.001). Although no stage IIIP patients were cured, 25% lived beyond 2 years. Five year DFS was significantly better in IIIN (45%) vs. IIIP (0%) patients (p<.001). The 65 patients without postoperative palpable disease, (stage I-IIIN) achieved DFS at 5 and 25 years of 69%, and 61%, respectively. Of 31 patients undergoing a second-look surgery, 84% were found to be free of tumor. Two recurred at 3.5 and 7 years after surgery. Acute tolerance was acceptable. Chronic toxicity included an 11.7% rate of small bowel obstruction requiring surgery and a 3% rate of

  15. Elderly victims of abuse: a five year document analysis

    OpenAIRE

    Garbin,Cléa Adas Saliba; Joaquim,Renata Colturato; Rovida,Tânia Adas Saliba; Garbin,Artênio José Isper

    2016-01-01

    Objective To verify the occurrence of maltreatment of the elderly and its characteristics (location, type, reason, involvement of alcohol/drugs, profile and family relationship of victims and perpetrators) from the police records of a specialized police station over a five year period. Method A cross-sectional, descriptive and documentary analytical study was performed. The police reports of a medium-sized municipality in the northwest of São Paulo were analyzed from 2008 to 2012. The sociod...

  16. Twenty five years of clusters -- from Bochum to Strasbourg

    International Nuclear Information System (INIS)

    Betts, R.R.; Chicago Univ., IL

    1994-01-01

    Developments in the area of clustering aspects of nuclear structure and reactions over the past twenty-five years are reviewed. The viewpoint is that the nucleus is an assembly of clusters. The question is whether clusters actually exist in the nucleus. Although there is abundant evidence for this in light nuclei, the situation for more complex clusters in heavier nuclei is much worse. Differential cross sections for scattering of alpha particles and heavy ions are shown

  17. Effect of Middle School Interventions on Alcohol Misuse and Abuse in Mexican American High School Adolescents: Five-Year Follow-up of a Randomized Clinical Trial.

    Science.gov (United States)

    Gonzales, Nancy A; Jensen, Michaeline; Tein, Jenn Yun; Wong, Jessie J; Dumka, Larry E; Mauricio, Anne Marie

    2018-03-21

    Substance abuse preventive interventions frequently target middle school students and demonstrate efficacy to prevent early onset and use of alcohol and illicit drugs. However, evidence of sustained results to prevent later patterns of alcohol misuse and more serious alcohol abuse disorders has been lacking, particularly for US Latino populations. To test whether a universal middle school prevention program can reduce the frequency of alcohol misuse and rates of alcohol use disorder 5 years after implementation with a Mexican American sample. A previous randomized clinical trial was conducted with 516 Mexican American 7th graders and at least 1 parent who identified as having Mexican origin. Three annual cohorts of families were recruited from rosters of 4 middle schools and randomized to the 9-session Bridges/Puentes family-focused group intervention or a workshop control condition. Recruitment, screening, pretest, and randomization occurred in the same academic year for each cohort: 2003-2004, 2004-2005, and 2005-2006. Data acquisition for the follow-up assessments of late-adolescent alcohol misuse and abuse, which were not included in the initial randomized clinical trial, was conducted from September 2009 to September 2014; analysis was conducted between August 2016 and July 2017. In this assessment, 420 children (81.4%) of the sample were included, when the majority were in their final year of high school. The 9-session Bridges/Puentes intervention integrated youth, parent, and family intervention sessions that were delivered in the spring semester at each school, with separate groups for English-dominant vs Spanish-dominant families. The control workshop was offered during the same semester at each school, also in English and Spanish. Primary outcomes were diagnostic assessment of lifetime alcohol use disorder in the 12th grade, 5 years after the intervention, based on the Diagnostic Interview Schedule for Children and past-year frequency of alcohol use

  18. Five years of solar UV-radiation monitoring in Sweden

    Energy Technology Data Exchange (ETDEWEB)

    Josefsson, Weine

    1996-10-01

    A network of five stations measuring the solar UV-radiation has been operated for about five years. Data are presented as plotted time-series of monthly and yearly values for the sites. A general climatology can be deduced from these data. Daily and hourly maximum values are shown for each month as indicators of the potential extreme exposure levels. The large annual variation at high latitudes is easily seen in the data set. This illustrates the importance of the solar elevation on the level of the UV-irradiance. Influence of cloud variation and of larger changes in ozone is also detectable. A few examples of the daily variation also show the strong solar elevation dependence of the UV-irradiance. The quantity and unit of the UV-radiation in this presentation is CIE-weighted irradiance expressed as MED (minimum erythermal dose), where one MED equals 210 Jm{sup -2}. The values have been recomputed to refer to the international intercomparison of broad-band meters in Helsinki in 1995. In the following named WMO-STUK 1995 scale. As will be seen there are many sources of error and detailed studies are prevented by the large uncertainty connected with these data. Due to the short period of the record and the low accuracy no attempt to study trends is done. 6 refs, 27 figs, 4 tabs

  19. Clinical anatomy e-cases: a five-year follow-up of learning analytics.

    Science.gov (United States)

    Perumal, Vivek; Butson, Russell; Blyth, Phil; Daniel, Ben

    2017-01-27

    This article explores the development and user experiences of a supplementary e-learning resource (clinical anatomy e-cases) for medical students, across a five-year teaching period. A series of online supplementary e-learning resources (the clinical anatomy e-cases) were developed and introduced to the regional and clinical anatomy module of the medicine course. Usage analytics were collected online from a cohort of third-year medical students and analysed to gain a better understanding of how students utilised these resources. Key results showed that the students used the supplementary learning resource during and outside regular teaching hours that includes a significant access during holidays. Analysis also suggested that the resources were frequently accessed during examination periods and during subsequent clinical study years (fourth or fifth years of medicine course). Increasing interest and positive feedback from students has led to the development of a further series of e-cases. Tailor-made e-learning resources promote clinical anatomy learning outside classroom hours and make supplementary learning a 24/7 task.

  20. FAMILY’S ECONOMIC LEVEL AND CULTURE CORRELATE WITH NUTRITIONAL STATUS OF CHILDREN UNDER FIVE YEARS

    Directory of Open Access Journals (Sweden)

    Abdul Muhith

    2017-01-01

    Full Text Available Introduction: Nutrition is an important thing for human life. Variety in family’s economic level and culture have effect on family’s eating habit. Family with higher economic status have big opportunity to met under fi ve year’s nutrition. Cultural diversity on each family has an impact on the difference of raw food selection, processing methods, and presentation of food. The purpose of this study was to determine the correlation between family’s economic level and culture with nutritional status of children under fi ve year. Method: Research design was observational analytic with cross sectional approach. The population were mother and their children under fi ve years at Desa Jatigono Kunir, Kabupaten Lumajang. Sampel were 184 respondents, taken by using cluster sampling. Independent variables were family’s economic level and culture. Dependent variable was nutritional status of children under fi ve years. Data were collected by using questionnaire and observational sheet. Then, data were analyzed by using Spearman Rho Test with α<0.05. Result: The results showed that 140 (76.1% respondents have low economic level, 105 (57.1% respondents have negative culture in children’s nutrition, and 89 (48% respondents have good nutritional status. The result of Spearman-rho test showed that family’s economic level (p=0.000 and culture (0.019 have correlated with nutritional status of children under five years. Discussion: It can be concluded that family’s economic level and culture have correlated with nutritional status of children under fi ve years. Nurses should develop health education and counseling to improve family’s knowledge about nutrition, so children will have good nutritional status. Keywords: economic level, family’s culture, nutritional status, children under five years

  1. Assessing the benefits of five years of different approaches to treatment of urogenital schistosomiasis: A SCORE project in Northern Mozambique.

    Directory of Open Access Journals (Sweden)

    Anna E Phillips

    2017-12-01

    Full Text Available In Mozambique, schistosomiasis is highly endemic across the whole country. The Schistosomiasis Consortium for Operational Research and Evaluation (SCORE coordinates a five-year study that has been implemented in various African countries, including Mozambique. The overall goal of SCORE was to better understand how to best apply preventive chemotherapy with praziquantel (PZQ for schistosomiasis control by evaluating the impact of alternative treatment approaches.This was a cluster-randomised trial that compared the impact of different treatment strategies in study areas with prevalence among school children of ≥21% S. haematobium infection by urine dipstick. Each village was randomly allocated to one of six possible combinations of community-wide treatment (CWT, school-based treatment (SBT, and/or drug holidays over a period of four years, followed by final data collection in the fifth year. The most intense intervention arm involved four years of CWT, while the least intensive arm involved two years of SBT followed by two consecutive years of PZQ holiday. Each study arm included 25 villages randomly assigned to one of the six treatment arms. The primary outcome of interest was change in prevalence and intensity of S. haematobium among 100 children aged 9-to-12-years that were sampled each year in every village. In addition to children aged 9-to-12 years, 100 children aged 5-8 years in their first-year of school and 50 adults (aged 20-55 years were tested in the first and final fifth year of the study. Prevalence and intensity of S. haematobium infection was evaluated by two filtrations, each of 10mL, from a single urine specimen.In total, data was collected from 81,167 individuals across 149 villages in ten districts of Cabo Delgado province, Northern Mozambique. Overall PZQ treatment resulted in a significant reduction in the prevalence of S. haematobium infection from Year 1 to Year 5, where the average prevalence went from 60.5% to 38

  2. Can repair increase the longevity of composite resins? Results of a 10-year clinical trial.

    Science.gov (United States)

    Fernández, E; Martín, J; Vildósola, P; Oliveira Junior, O B; Gordan, V; Mjor, I; Bersezio, C; Estay, J; de Andrade, M F; Moncada, G

    2015-02-01

    The aim of this double-blind clinical trial was to assess the longevity of repairs to localized clinical defects in composite resin restorations that were initially planned to be treated with a restoration replacement. Twenty-eight patients aged 18-80 years old with 50 composite resin restorations (CR) were recruited. The restorations with localized, marginal, anatomical deficiencies and/or secondary caries adjacent to CR that were "clinically judged" to be suitable for repair or replacement according to the USPHS criteria were randomly assigned to Repair (n=25) or Replacement (n=25) groups, and the quality of the restorations was scored according to the modified USPHS criteria. The restorations were blind and two examiners scored them at baseline (Cohen Kappa agreement score 0.74) and at ten years (Cohen Kappa agreement score 0.87) restorations. Wilcoxon tests were performed for comparisons within the same group (95% CI), and Friedman tests were utilized for multiple comparisons between the different years within each group. Over the decade, the two groups behaved similarly on the parameters of marginal adaptation (MA) (p>0.05), secondary caries (SC) (p>0.05), anatomy (A) (p0.05). Given that the MA, SC, A and C parameters behaved similarly in both groups, the repair of composite resins should be elected when clinically indicated, because it is a minimally invasive treatment that can consistently increase the longevity of restorations. The repair of defective composite resins as an alternative treatment to increase their longevity proved to be a safe and effective treatment in the long term. Copyright © 2014 Elsevier Ltd. All rights reserved.

  3. Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration.

    Directory of Open Access Journals (Sweden)

    Amelia Scott

    Full Text Available To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.Any clinical trial (as defined by ICMJE published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry and conducted after July 2005 (or 2007 for two journals was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6% were deemed unregistered, 61 (33.7% were retrospectively registered, 37 (20.4% had unclear POMs either in the article or the registry and 2 (1.1% were registered in an inaccessible trial registry. Only 60 (33.1% studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3% showed evidence of selective outcome reporting and 16 (26.7% demonstrated a change in participant numbers of 20% or more; only 26 (14

  4. Esophageal adenocarcinoma five years after laparoscopic sleeve gastrectomy. A case report

    Directory of Open Access Journals (Sweden)

    Fernando Gabriel Wright

    2017-01-01

    Conclusion: We present a case of an esophageal adenocarcinoma five years after a laparoscopic sleeve gastrectomy for morbid obesity. There is need to better determine the relationship between sleeve gastrectomy and gastroesophageal reflux disease in order to prevent its related complications, such as esophageal adenocarcinoma.

  5. Crestal Sinus Augmentation with Recombinant Human Bone Morphogenetic Protein 2: Clinical and Radiographic Outcomes of 2-Year Pilot Trial.

    Science.gov (United States)

    Kuchler, Ulrike; Rudelstorfer, Claudia M; Barth, Barbara; Tepper, Gabor; Lidinsky, Dominika; Heimel, Patrick; Watzek, Georg; Gruber, Reinhard

    Recombinant human bone morphogenetic protein 2 (rhBMP-2) together with an absorbable collagen carrier (ACS) was approved for augmentation of the maxillary sinus prior to implant placement. The original registration trial was based on a lateral window approach. Clinical outcomes of crestal sinus augmentation with rhBMP-2 have not been reported so far. An uncontrolled pilot trial in which seven patients with a residual maxillary height below 5 mm were enrolled to receive crestal sinus augmentation with rhBMP-2/ACS was conducted. Elevation of the sinus mucosa was performed by gel pressure. Primary endpoints were the gain in augmentation height and volume measured by computed tomography after 6 months. Evaluation of bone quality at the time of implant placement was based on histology. Secondary endpoints were the clinical and radiologic evaluation of the implants and patient satisfaction by visual analog scale (VAS) at the 2-year follow-up. Median gain in augmentation height was 7.2 mm (range 0.0 to 17.5 mm). Five patients gained at least 5 mm of bone height. Two patients with a perforation of the sinus mucosa failed to respond to rhBMP-2/ACS and underwent lateral window augmentation. The median gain in augmentation volume of the five patients was 781.3 mm³ (range 426.9 to 1,242.8 mm³). Biopsy specimens showed a cancellous network consisting of primary plexiform bone with little secondary lamellar bone. After 2 years, implants were in function with no signs of inflammation or peri-implant bone loss. Patients were satisfied with the esthetic outcomes and chewing function. This pilot clinical trial supports the original concept that rhBMP-2/ACS supports bone formation, also in crestal sinus augmentation, and emphasizes the relevance of the integrity of the sinus mucosa to predict the bone gain.

  6. Does levodopa improve vision in albinism? Results of a randomized, controlled clinical trial.

    Science.gov (United States)

    Summers, C Gail; Connett, John E; Holleschau, Ann M; Anderson, Jennifer L; De Becker, Inge; McKay, Brian S; Brilliant, Murray H

    2014-11-01

    Dopamine is an intermediate product in the biosynthesis of melanin pigment, which is absent or reduced in albinism. Animal research has shown that supplying a precursor to dopamine, levodopa, may improve visual acuity in albinism by enhancing neural networks. This study examines the safety and effectiveness of levodopa on best-corrected visual acuity in human subjects with albinism. Prospective, randomized, placebo-controlled, double-masked clinical trial conducted at the University of Minnesota. Forty-five subjects with albinism. Subjects with albinism were randomly assigned to one of three treatment arms: levodopa 0.76 mg/kg with 25% carbidopa, levodopa 0.51 mg/kg with 25% carbidopa, or placebo and followed for 20 weeks, with best-corrected visual acuity measured at enrollment, and at weeks 5, 10, 15, and 20 after enrollment. Side-effects were recorded with a symptom survey. Blood was drawn for genotyping. Side-effects and best-corrected visual acuity 20 weeks after enrolment. All subjects had at least one mutation found in a gene known to cause albinism. Mean age was 14.5 years (range: 3.5 to 57.8 years). Follow up was 100% and compliance was good. Minor side-effects were reported; there were no serious adverse events. There was no statistically significant improvement in best-corrected visual acuity after 20 weeks with either dose of levodopa. Levodopa, in the doses used in this trial and for the time course of administration, did not improve visual acuity in subjects with albinism. © 2014 Royal Australian and New Zealand College of Ophthalmologists.

  7. [Primary prevention of cardiovascular diseases: long term results of five year long preventive intervention in 12-year old boys (ten year prospective study)].

    Science.gov (United States)

    Rozanov, V B; Aleksandov, A A; Shugaeva, E N; Perova, N V; Maslennikova, G Ia; Smirnova, S G; Olfer'ev, A M

    2007-01-01

    In a longitudinal cohort (prevention group, n=213, comparison group, n=163) of 10-year prospective follow-up we addressed efficacy of 5-year-long multifactor preventive intervention, conducted in a sample of population of 12 year old boys. Preventive intervention was carried out both at populational level and among persons with risk factors of development of cardiovascular diseases with the use of group, individual, and partly family approaches, and was directed at rationalization of nutrition, elevation of physical activity and prevention of harmful habits. During first 3 years of prevention we succeeded to achieve stable statistically significant lowering of mean levels of total cholesterol, low density lipoprotein cholesterol, triglycerides, and atherogeneity index, as well as to affect fatty component of body mass (skinfold thickness). Long term effect of 5-year long preventive intervention manifested as significantly lower level of systolic blood pressure, lower prevalence of low levels of high density lipoprotein cholesterol, smaller increment of low density lipoprotein cholesterol and index of atherogeneity in the prevention group. These results evidence that prevention of main factors of risk of development of cardiovascular diseases (obesity, arterial hypertension, disorders of lipid composition of the blood, and low physical activity) in child and adolescent age in the period of active growth and development is feasible, effective, safe and is able to lead to decrease of levels of these factors in adults, but should last uninterruptedly until formation of stable habits of healthy life style.

  8. Androgen suppression plus radiation vs. radiation alone for patients with D1 (pN+) adenocarcinoma of the prostate (results based on a national prospective randomized trial RTOG 85-31)

    International Nuclear Information System (INIS)

    Lawton, Colleen A.; Pajak, Thomas F.; Byhardt, Roger; Sause, William T.; Hanks, Gerald E.; Russell, Anthony H.; Rotman, Marvin; Porter, Arthur; McGowan, David G.; DelRowe, John D.; Pilepich, Miljenko V.

    1996-01-01

    Purpose/Objective: To evaluate the effect of immediate androgen suppression in conjunction with standard external beam irradiation versus radiation alone on a group of pathologically staged lymph node positive patients with adenocarcinoma of the prostate. Methods and Materials: A national prospective randomized trial of standard external beam irradiation plus immediate androgen suppression vs. external beam irradiation alone was initiated in 1985 for patients with locally advanced adenocarcinoma of the prostate. One hundred seventy two of the patients in this trial had biopsy proven pathologically involved lymph nodes. Ninety Eight of these patients received radiation plus the immediate androgen suppression (LHRH agonist) while 74 received radiation alone with hormonal manipulation instituted at the time of relapse. Results: With a median followup of 3.9 years actuarial progression free survival at five years was 56% for the patients who received radiation plus immediate LHRH agonist versus 33% patients who received radiation alone with hormonal manipulation at relapse (p = .0009). Since all of these patients had locally advanced disease (i.e. pathologically positive lymph nodes) stage does not explain this difference in outcome and gleason grade was not statistically different between the two groups. Although not statistically different at this point both overall survival and cause specific survival favor radiation and immediate LHRH agonist. Actuarial overall survival at five years for the radiation and LHRH group was 69% versus 59% for the radiation alone group who received androgen suppression at relapse. Actuarial cause specific survival at five years was 84% for the radiation and immediate LHRH agonist group and 73% for the radiation alone group. Conclusion: Patients with adenocarcinoma of the prostate and pathologically involved pelvic lymph nodes (pN+ or clinical stage D 1 ) should be seriously considered for external beam irradiation plus immediate

  9. Intraoperative photodynamic therapy of bladder cancer with alasens (results of multicenter trial

    Directory of Open Access Journals (Sweden)

    E. V. Filonenko

    2014-01-01

    Full Text Available The results of multicenter prospective trial for efficacy of combined modality treatment: transurethral resection (TUR + photodynamic therapy (PDT with alasens for bladder cancer are represented in the article. Trials were organized by Research Institute of Organic Intermediates and Dyes and conducted according to clinical protocol approved by Ministry of Health of Russia, at the sites of leading Russian cancer clinical centers. The trial included 45 subjects with verified diagnosis of non-muscle-invasive bladder cancer. Patients underwent TUR of bladder with simultaneous PDT as anti-relapse treatment. Alasens was administered to patients as intravesicular instillation of 3% solution in volume of 50 ml with 1.5–2h exposure (prior to TUR. TUR was performed after instillation. PDT session was conducted immediately after the completion of TUR on a single occasion by means of combined local irradiation on tumor bed with diffuse irradiation on whole urinary bladder mucosa (light dose of local irradiation – 100 J/cm2, diffuse irradiation – 20 J/cm2. Good tolerance of the treatment was noticed, there were no complications. Among 45 patients included in the trial, 35 (78% completed 12 month protocol follow-up without relapse. The recurrence of bladder tumor was registered in 10 (22% cases 6–12 months after TUR+PDT including 3 patients with recurrence 6 months after treatment, 3–9 months and 4–12 months. These patients underwent repeated TUR, whereafter their follow-up in the settings of the clinical trial was disposed. Thus, PDT with alasens after TUR allowed to decrease the recurrence rate of non-muscle-invasive bladder cancer for 1st year after treatment to 22% versus 40–80% for TUR as monotherapy according to literature data. The obtained results were comparable by efficiency with TUR combined with methods of adjuvant treatment for bladder tumors (the recurrence rates for 1-year follow-up after TUR+chemotherapy – 36–44%, after TUR

  10. Five-year survival in 309 patients with colorectal liver metastases treated with radiofrequency ablation

    International Nuclear Information System (INIS)

    Gillams, A.R.; Lees, W.R.

    2009-01-01

    There is little published long-term survival data for patients with colorectal liver metastases treated with radiofrequency ablation (RFA). We present a multivariate analysis of 5-year survival in 309 patients (198 male, aged 64 (24-92)) treated at 617 sessions. Our standard protocol used internally cooled electrodes introduced percutaneously under combined US and CT guidance/monitoring. The number and size of liver metastases, the presence and location of extrahepatic disease, primary resection, clinical, chemotherapy and follow-up data were recorded. Data analysis was performed using SPSS v.10. On multivariate analysis, significant survival factors were the presence of extrahepatic disease (p < 0.001) and liver tumour volume (p = 0.001). For 123 patients with five or less metastases of 5 cm or less maximum diameter and no extrahepatic disease median survival was 46 and 36 months from liver metastasis diagnosis and ablation, respectively; corresponding 3- and 5-year survival rates were 63%, 34% and 49%, 24%. Sixty-nine patients had three or less tumours of below 3.5 cm in diameter and their 5-year survival from ablation was 33%. There were 23/617(3.7%) local complications requiring intervention. Five-year survival of 24-33% post ablation in selected patients is superior to any published chemotherapy data and approaches the results of liver resection. (orig.)

  11. Error identification in a high-volume clinical chemistry laboratory: Five-year experience.

    Science.gov (United States)

    Jafri, Lena; Khan, Aysha Habib; Ghani, Farooq; Shakeel, Shahid; Raheem, Ahmed; Siddiqui, Imran

    2015-07-01

    Quality indicators for assessing the performance of a laboratory require a systematic and continuous approach in collecting and analyzing data. The aim of this study was to determine the frequency of errors utilizing the quality indicators in a clinical chemistry laboratory and to convert errors to the Sigma scale. Five-year quality indicator data of a clinical chemistry laboratory was evaluated to describe the frequency of errors. An 'error' was defined as a defect during the entire testing process from the time requisition was raised and phlebotomy was done until the result dispatch. An indicator with a Sigma value of 4 was considered good but a process for which the Sigma value was 5 (i.e. 99.977% error-free) was considered well controlled. In the five-year period, a total of 6,792,020 specimens were received in the laboratory. Among a total of 17,631,834 analyses, 15.5% were from within hospital. Total error rate was 0.45% and of all the quality indicators used in this study the average Sigma level was 5.2. Three indicators - visible hemolysis, failure of proficiency testing and delay in stat tests - were below 5 on the Sigma scale and highlight the need to rigorously monitor these processes. Using Six Sigma metrics quality in a clinical laboratory can be monitored more effectively and it can set benchmarks for improving efficiency.

  12. Five years of operating experience with Phenix

    International Nuclear Information System (INIS)

    Conte, F.

    1980-01-01

    The construction of Phenix began at the end of 1968; the unit first went critical on August 31 st, 1973, and it was first connected to the grid of Electricite de France on 31st December 1973. It started operating industrially on July 14th, 1974. The balance sheet after five years of operations is as follows: Gross thermal capacity: 590 MW; Grosss electric capacity: 264 MW; Gross capacity factor of the power station: 45%; Gross electrical power produced by 30th september 1979: more than six billion kWh. In 1976 and 1977 the operation of the plant was affected by modifications made to the intermediate heat exchangers following leaks discovered in October 1976. Since 1976 the plants has been working at full capacity and the availability rate during the period July 1978 - July 1979 was more than 80% [fr

  13. Nutrition and public hygiene among children under five years of age ...

    African Journals Online (AJOL)

    Objective: To determine the relationship between sanitation and malnutrition among children below five years. Design: A random sampling followed by an experimental design on microbiological analysis of food and water samples. Setting: Mukuru slums of Makadara division in Nairobi City. Subjects: Eighty food and thirty ...

  14. [Chronic malnutrition among children under five years of age in the northern part of Côte d'Ivoire].

    Science.gov (United States)

    Aké-Tano, Odile; Tiembré, Issaka; Konan, Yao Eugène; Donnen, Philippe; Dagnan, Simplice N'cho; Dramaix, Michelle; Koffi, Kouamé; Diarra-Nama, Alimata Jeanne

    2010-01-01

    The malnutrition of children under five years of age constitutes a major public health problem in most developing countries. A cross-section study was carried in 2003 in the northern part of Côte d'Ivoire to determine the prevalence of chronic malnutrition and to identify risk factors among children under five years of age living in urban and rural areas of the northern part of Côte d'Ivoire. A total of 292 and 268 children under five years of age residing respectively in urban and rural areas were included in the study. Their median age was 24 months. Chronic malnutrition was more frequent in children from rural areas (39.9%) than in those living in urban areas (16.7%). Malnutrition was significantly associated with the type of food consumed by children under two years of age in urban areas, and it was strongly linked to emaciation of the mother and presence of childhood fever in rural areas. In light of these results, we advocate a healthy diet and adequate health status for the mother and child to improve the nutritional status of children. Moreover, these results need to be completed and complemented by further studies for more detailed information to contribute to a better definition of actions to fight efficiently against malnutrition among children of the northern part of Côte d'Ivoire.

  15. After Twenty-Five Years: A Twenty-Five Year Follow-up Study of Middlesex County Vocational and Technical High School Graduates of the Class of June 1953.

    Science.gov (United States)

    Rogers, William; Zanzalari, J. Henry

    A twenty-five-year follow-up study was conducted to determine the occupational, educational, marital and armed forces experiences of the graduating class of 1953 from the Middlesex County Vocational and Technical high schools located in New Brunswick, Perth, Amboy, and Woodbridge, New Jersey. Data, in the form of questionnaire responses, were…

  16. Monetary value of lost productivity over a five year follow up in early rheumatoid arthritis estimated on the basis of official register data on patients' sickness absence and gross income: experience from the FIN-RACo trial.

    Science.gov (United States)

    Puolakka, K; Kautiainen, H; Pekurinen, M; Möttönen, T; Hannonen, P; Korpela, M; Hakala, M; Arkela-Kautiainen, M; Luukkainen, R; Leirisalo-Repo, M

    2006-07-01

    To explore the monetary value of rheumatoid arthritis related loss of productivity in patients with early active disease. In a prospective cohort substudy of the FIN-RACo Trial, 162 patients with recent onset rheumatoid arthritis, aged 18 to 65 years and available to the workforce, were followed up for five years. Loss of work productivity in euros 2002 was estimated by data on absence for sickness and on income (human capital approach) from official databases. Treatment responses were evaluated by area under the curve (AUC) of the ACR-N measure and by increase in number of erosions in radiographs of hands and feet. The health assessment questionnaire (HAQ) at six months was linked to the International Classification of Functioning, Disability and Health (ICF). In all, 120 (75%) patients, women more often (82%) than men (61%) (p=0.002), lost work days. The mean lost productivity per patient-year was euro7217 (95% confidence interval (CI), 5561 to 9148): for women, euro6477 (4858 to 8536) and for men, euro8443 (5389 to 12,898). There was an inverse correlation with improvement: euro1101 (323 to 2156) and euro14 952 (10,662 to 19,852) for the highest and lowest quartiles of AUC of ARC-N, respectively. Lost productivity was associated with increase in the number of erosions and with disability in "changing and maintaining body position" subcategory of the ICF. Despite remission targeted treatment with disease modifying antirheumatic drugs, early rheumatoid arthritis results in substantial loss of productivity. A good improvement in the disease reduces the loss markedly.

  17. Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia Patients Trial.

    Science.gov (United States)

    Cortes, Jorge E; Saglio, Giuseppe; Kantarjian, Hagop M; Baccarani, Michele; Mayer, Jiří; Boqué, Concepción; Shah, Neil P; Chuah, Charles; Casanova, Luis; Bradley-Garelik, Brigid; Manos, George; Hochhaus, Andreas

    2016-07-10

    We report the 5-year analysis from the phase III Dasatinib Versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia Patients (DASISION) trial, evaluating long-term efficacy and safety outcomes of patients with chronic myeloid leukemia (CML) in chronic phase (CP) treated with dasatinib or imatinib. Patients with newly diagnosed CML-CP were randomly assigned to receive dasatinib 100 mg once daily (n = 259) or imatinib 400 mg once daily (n = 260). At the time of study closure, 61% and 63% of dasatinib- and imatinib-treated patients remained on initial therapy, respectively. Cumulative rates of major molecular response and molecular responses with a 4.0- or 4.5-log reduction in BCR-ABL1 transcripts from baseline by 5 years remained statistically significantly higher for dasatinib compared with imatinib. Rates for progression-free and overall survival at 5 years remained high and similar across treatment arms. In patients who achieved BCR-ABL1 ≤ 10% at 3 months (dasatinib, 84%; imatinib, 64%), improvements in progression-free and overall survival and lower rates of transformation to accelerated/blast phase were reported compared with patients with BCR-ABL1 greater than 10% at 3 months. Transformation to accelerated/blast phase occurred in 5% and 7% of patients in the dasatinib and imatinib arms, respectively. Fifteen dasatinib-treated and 19 imatinib-treated patients had BCR-ABL1 mutations identified at discontinuation. There were no new or unexpected adverse events identified in either treatment arm, and pleural effusion was the only drug-related, nonhematologic adverse event reported more frequently with dasatinib (28% v 0.8% with imatinib). First occurrences of pleural effusion were reported with dasatinib, with the highest incidence in year 1. Arterial ischemic events were uncommon in both treatment arms. These final results from the DASISION trial continue to support dasatinib 100 mg once daily as a safe and effective first-line therapy for the long

  18. A Five-Year School Building and Future Sites Program 1966-1970.

    Science.gov (United States)

    1965

    Five-year school building and site needs and related financial requirements are summarized for Milwaukee's schools. Educational policies concerning the school building program are stated, and consideration is given to factors affecting school board needs such as birth rate, public housing projects, urban renewal, highways, and expressways. School…

  19. [Prevalence of overwight and obesity among children under five years in Peru 2007-2010].

    Science.gov (United States)

    Pajuelo-Ramírez, Jaime; Miranda-Cuadros, Marianella; Campos-Sánchez, Miguel; Sánchez-Abanto, José

    2011-06-01

    To estimate the prevalence of overweight and obesity in children under five in Peru in the years 2007-2010 and to describe according to geographical areas, poverty levels, maternal education, breastfeeding, child age, sex and birth weight. continuous (repeated cross-sectional) multistage, random sampling survey from the universe of children under five-years and pregnant women living in Peru, divided into five geographical areas. Out of 3,669 children, 50.3% were males (Lima N=680, Remaining Coast N=763, Urban Sierra N=719, Rural Sierra N=699, Jungle N=808) having their weight and height measured according to international standards. The national prevalence of overweight and obesity was 6.9%, with Metropolitan Lima (10.1%) as the highest and in the Jungle (2.6%) as the lowest. Age, sex, geographical area and birth weight were identified as risk factors through multiple logistic regression. overweight and obesity are higher in Lima, during the first year of age and when birth weight is more than 2.5 Kg.

  20. Five-year follow-up using a prostate stent as fiducial in image-guided radiotherapy of prostate cancer.

    Science.gov (United States)

    Carl, Jesper; Sander, Lotte

    2015-06-01

    To report results from the five-year follow-up on a previously reported study using image-guided radiotherapy (IGRT) of localized or locally advanced prostate cancer (PC) and a removable prostate stent as fiducial. Patients with local or locally advanced PC were treated using five-field 3D conformal radiotherapy (3DRT). The clinical target volumes (CTV) were treated to 78 Gy in 39 fractions using daily on-line image guidance (IG). Late genito-urinary (GU) and gastro-intestinal (GI) toxicities were scored using the radiotherapy oncology group (RTOG) score and the common toxicity score of adverse events (CTC) score. Urinary symptoms were also scored using the international prostate symptom score (IPSS). Median observation time was 5.4 year. Sixty-two of the 90 patients from the original study cohort were eligible for toxicity assessment. Overall survival, cancer-specific survival and biochemical freedom from failure were 85%, 96% and 80%, respectively at five years after radiotherapy. Late toxicity GU and GI RTOG scores≥2 were 5% and 0%. Comparing pre- and post-radiotherapy IPSS scores indicate that development in urinary symptoms after radiotherapy may be complex. Prostate image-guided radiotherapy using a prostate stent demonstrated survival data comparable with recently published data. GU and GI toxicities at five-year follow-up were low and comparable to the lowest toxicity rates reported. These findings support that the precision of the prostate stent technique is at least as good as other techniques. IPSS revealed a complex development in urinary symptoms after radiotherapy.

  1. [Five years of ROM in substance abuse treatment centres in the Netherlands].

    Science.gov (United States)

    Oudejans, S C C; Schippers, G M; Spits, M E; Stollenga, M; van den Brink, W

    2012-01-01

    Three substance abuse treatment centres set up a benchmarking project for routine outcome management (ROM) of structured cognitive behavioral treatments for outpatients with a substance use disorder. To present the results of five years benchmarking. All patients were included at intake and the follow-up assessment was performed by a call-center nine months later. Twice a year aggregated data were fed back to management and treatment teams. Since 2005, clinical outcome data, including substance abuse data, have been collected for more than half of all 15.786 treated patients. At follow-up, nine months after intake, 23% was abstinent, 28% reported moderate substance use and 49% reported excessive substance use. The Dutch centres for the treatment of substance abuse were successful in setting up ROM projects to monitor and compare the development and the effects of outpatient addiction treatments. The clinical results are acceptable and correspond to the results of the American project called match. It is not yet clear whether the biannual feedback of aggregated outcomes to management and treatment teams has contributed to the creation of learning organisations, but it has provided transparency and has made it possible for teams to learn from the outcomes.

  2. [State of the quality of drinking water in households in children under five years in Peru, 2007-2010].

    Science.gov (United States)

    Miranda, Marianella; Aramburú, Adolfo; Junco, Jorge; Campos, Miguel

    2010-01-01

    To evaluate the proportion of children under five with access to quality water and its behavior according to geographical location, water supply and poverty status. Continuous survey (repeated cross), with multistage random sampling, being the universe children under five years living in Peru. We evaluated the presence of free chlorine in drinking water samples in the dwellings of 3570 children (Metropolitan Lima 666, Rest of Coast 755, Urban Sierra 703, Rural Sierra 667, and Jungle 779). We evaluated the presence of total coliforms and E. coli in water samples of 2310 households (445 Metropolitan Lima, Rest of Coast 510, Urban Sierra 479, Rural Sierra Selva 393 and 483). The national proportion of children under five years living in households with adequate free chlorine in drinking water reaches 19.5% of the total, while water free of coliforms and E. coli is 38.3%. There is a marked difference in results by area of residence (the most affected areas were rural Sierra and Jungle), public network at home inside the dwelling and income quintiles. Children under five years living in households belonging to the rural areas and extreme poverty, have a great disadvantage to access quality water consumption. This situation represents a serious problem for the control of diarrheal diseases and children malnutrition.

  3. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation : two year results of a randomised controlled trial

    NARCIS (Netherlands)

    Peul, W.C.; Hout, van den W.B.; Brand, R.; Thomeer, R.T.W.M.; Koes, B.W.

    2008-01-01

    Objectives: To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up. Design: Randomised controlled trial. Setting: Nine Dutch hospitals. Participants: 283 patients with 6-12 weeks of sciatica.

  4. The Effect of Treatment Advances on the Mortality Results of Breast Cancer Screening Trials: A Microsimulation Model.

    Science.gov (United States)

    Birnbaum, Jeanette; Gadi, Vijayakrishna K; Markowitz, Elan; Etzioni, Ruth

    2016-02-16

    Mammography trials, which are the primary sources of evidence for screening benefit, were conducted decades ago. Whether advances in systemic therapies have rendered previously observed benefits of screening less significant is unknown. To compare the outcomes of breast cancer screening trials had they been conducted using contemporary systemic treatments with outcomes of trials conducted with previously used treatments. Computer simulation model of 3 virtual screening trials with similar reductions in advanced-stage cancer cases but reflecting treatment patterns in 1975 (prechemotherapy era), 1999, or 2015 (treatment according to receptor status). Meta-analyses of screening and treatment trials; study of dissemination of primary systemic treatments; SEER (Surveillance, Epidemiology, and End Results) registry. U.S. women aged 50 to 74 years. 10 and 25 years. Population. Mammography, chemotherapy, tamoxifen, aromatase inhibitors, and trastuzumab. Breast cancer mortality rate ratio (MRR) and absolute risk reduction (ARR) obtained by the difference in cumulative breast cancer mortality between control and screening groups. At 10 years, screening in a 1975 trial yielded an MRR of 90% and an ARR of 5 deaths per 10,000 women. A 2015 screening trial yielded a 10-year MRR of 90% and an ARR of 3 deaths per 10,000 women. Greater reductions in advanced-stage disease yielded a greater screening effect, but MRRs remained similar across trials. However, ARRs were consistently lower under contemporary treatments. When contemporary treatments were available only for early-stage cases, the MRR was 88%. Disease models simplify reality and cannot capture all breast cancer subtypes. Advances in systemic therapies for breast cancer have not substantively reduced the relative benefits of screening but have likely reduced the absolute benefits because of their positive effect on breast cancer survival. University of Washington and National Cancer Institute.

  5. Randomised clinical trial of five ear acupuncture points for the treatment of overweight people.

    Science.gov (United States)

    Yeo, Sujung; Kim, Kang Sik; Lim, Sabina

    2014-04-01

    To evaluate the efficacy of the five ear acupuncture points (Shen-men, Spleen, Stomach, Hunger, Endocrine), generally used in Korean clinics for treating obesity, and compare them with the Hunger acupuncture point. A randomised controlled clinical trial was conducted in 91 Koreans (16 male and 75 female, body mass index (BMI)≥23), who had not received any other weight control treatment within the past 6 months. Subjects were divided randomly into treatment I, treatment II or sham control groups and received unilateral auricular acupuncture with indwelling needles replaced weekly for 8 weeks. Treatment I group received acupuncture at the five ear acupuncture points, treatment II group at the Hunger acupuncture point only and the sham control group received acupuncture at the five ear acupuncture points used in treatment I, but the needles were removed immediately after insertion. BMI, waist circumference, weight, body fat mass (BFM), percentage body fat and blood pressure were measured at baseline and at 4 and 8 weeks after treatment. For the 58 participants who provided data at 8 weeks, significant differences in BMI, weight and BFM were found between the treatment and control groups. Treatment groups I and II showed 6.1% and 5.7% reduction in BMI, respectively (pfive ear acupuncture points, generally used in Korean clinics, and the Hunger point alone treatment are both effective for treating overweight people.

  6. Two to five repeated measurements per patient reduced the required sample size considerably in a randomized clinical trial for patients with inflammatory rheumatic diseases

    Directory of Open Access Journals (Sweden)

    Smedslund Geir

    2013-02-01

    Full Text Available Abstract Background Patient reported outcomes are accepted as important outcome measures in rheumatology. The fluctuating symptoms in patients with rheumatic diseases have serious implications for sample size in clinical trials. We estimated the effects of measuring the outcome 1-5 times on the sample size required in a two-armed trial. Findings In a randomized controlled trial that evaluated the effects of a mindfulness-based group intervention for patients with inflammatory arthritis (n=71, the outcome variables Numerical Rating Scales (NRS (pain, fatigue, disease activity, self-care ability, and emotional wellbeing and General Health Questionnaire (GHQ-20 were measured five times before and after the intervention. For each variable we calculated the necessary sample sizes for obtaining 80% power (α=.05 for one up to five measurements. Two, three, and four measures reduced the required sample sizes by 15%, 21%, and 24%, respectively. With three (and five measures, the required sample size per group was reduced from 56 to 39 (32 for the GHQ-20, from 71 to 60 (55 for pain, 96 to 71 (73 for fatigue, 57 to 51 (48 for disease activity, 59 to 44 (45 for self-care, and 47 to 37 (33 for emotional wellbeing. Conclusions Measuring the outcomes five times rather than once reduced the necessary sample size by an average of 27%. When planning a study, researchers should carefully compare the advantages and disadvantages of increasing sample size versus employing three to five repeated measurements in order to obtain the required statistical power.

  7. Fuel quality control: Five years of activity in laboratories

    International Nuclear Information System (INIS)

    Bettinelli, M.; Cimini, G.; Durello, G.; Lucchesi, P.L.

    1991-01-01

    A description of how ENEL (Italian National Electricity Board) carries out the activity of fuel quality control is given, and the results of the Round Robin circuit which has been operating for five years in laboratories regulary performing the control analyses of these products are reported. The laboratories taking part in the Round Robin circuit are 41 (out of which 35 are ENEL laboratories and 6 are owned by external companies) and they are situated throughout Italy; the controlled parameters are the following: heat of combustion (PCS), sulphur (S), vanadium (V) and asphaltenes (ASF); the adopted methods are the official ASTM or IP ones. The statistical analysis of the results has permitted, for every parameter, the calculation of the repeatability and the reproducibility which, in most cases, have turned out to be in keeping with the values provided for in the regulations. Among the collateral initiatives promoted in the framework of this Round Robin, the following are reported: preparation of standards of fuel oil with a known content of a sulphur and vanadium; expediting visits to all the ENEL laboratories participating in the RRT; publication of a handbook of the adopted analysis methods (in Italian); definition of guide-lines on the right selection of new automatic equipment

  8. Prevalence of rotavirus among children under five years of age with ...

    African Journals Online (AJOL)

    Rotavirus (RV) is a major etiological agent of acute infantile gastroenteritis and is associated with 20%-25% of diarrhea cases in infants. Nigeria continues to be among the first five countries with greatest number of RV disease associated deaths per year. The objective was to determine some demographic factors that might ...

  9. Public comments and responses to the 1993 Hanford cleanup five-year plan

    International Nuclear Information System (INIS)

    1993-08-01

    In March 1993, the US Department of Energy, Richland Operations Office (DOE-RL) published its annual Site-Specific Five-Year Plan. The Site-Specific Plan is published to inform the public about the background, status, and plans for Environmental Restoration (ER) and Waste Management (WM) activities at the Hanford site. It is the only document that seeks to bring all ER and WM elements together in one document. The Site-Specific Plan is a companion document to the National Five-Year Plan that deals with all the sites within the DOE complex on a summary level. This Response to Comments document does not try to address every question or concern raised during the public comment period. Some questions were outside the scope of the Five-Year Plan, some we could not decipher, others were variations of the same question. The initial round of public meetings was held in Portland, Oregon, and Seattle, Pasco, and Olympia, Washington. At the request of the Oregon Department of Energy (ODOE) and the Washington State Department of Ecology (Ecology), a second round of meetings was held in Portland and Olympia. Both agencies felt that the first two meetings were held with too little advance notice, and before the Plan could be distributed. Once the public meetings were over and the comment period closed, we then compiled the public comments, largely from audio tapes of the meetings. Individual functions within Hanford were asked to consider and respond to the comments

  10. Does life satisfaction predict five-year mortality in community-living older adults?

    Science.gov (United States)

    St John, Philip D; Mackenzie, Corey; Menec, Verena

    2015-01-01

    Depression and depressive symptoms predict death, but it is less clear if more general measures of life satisfaction (LS) predict death. Our objectives were to determine: (1) if LS predicts mortality over a five-year period in community-living older adults; and (2) which aspects of LS predict death. 1751 adults over the age of 65 who were living in the community were sampled from a representative population sampling frame in 1991/1992 and followed five years later. Age, gender, and education were self-reported. An index of multimorbidity and the Older American Resource Survey measured health and functional status, and the Terrible-Delightful Scale assessed overall LS as well as satisfaction with: health, finances, family, friends, housing, recreation, self-esteem, religion, and transportation. Cox proportional hazards models examined the influence of LS on time to death. 417 participants died during the five-year study period. Overall LS and all aspects of LS except finances, religion, and self-esteem predicted death in unadjusted analyses. In fully adjusted analyses, LS with health, housing, and recreation predicted death. Other aspects of LS did not predict death after accounting for functional status and multimorbidity. LS predicted death, but certain aspects of LS are more strongly associated with death. The effect of LS is complex and may be mediated or confounded by health and functional status. It is important to consider different domains of LS when considering the impact of this important emotional indicator on mortality among older adults.

  11. Five-yearly review: where do we stand now?

    CERN Multimedia

    Staff Association

    2016-01-01

    A reminder The first issue of Echo in 2016 announced a year of changes with many challenges for the Staff Association and the staff it represents. Indeed, following the decision of the Council in December 2015 to approve all components of the five-yearly review, many changes were to be implemented in 2016. This is the case of the new career structure, the definition of benchmark jobs (BMJ), the redesign of the advancement and promotions process, etc. Looking back at 2015 and the various statements In December 2015, the CERN Council emphasized: the substantial effort made by the Staff Association and the Management, taking into account the difficult economic situation faced by some Member States, led to the creation of a package of measures as balanced as possible. It is clear however: that there was no alignment of CERN basic salaries with the comparison salaries; that in the new career system, staff will have their advancement prospects, and consequently the level of their pension, reduced with respect to ...

  12. [Effects of daily physical exercise at school on cardiovascular risk--results of a 2-year cluster-randomized study].

    Science.gov (United States)

    Walther, C; Mende, M; Gaede, L; Müller, U; Machalica, K; Schuler, G

    2011-11-01

    It was the aim of this study to measure the effects over two years of daily sport activity during the school-day on their physical fitness (primary endpoint), motor coordination and blood pressure (secondary endpoints). A total of 232 children from eleven different 6 (th) grade classes were enrolled after informed parental consent. Their mean age was 11.1  ±  0.6 years. Six classes were randomly assigned for intervention (n=141), five as control (n=91). Those of the intervention cohort undertook, for five days weekly during the school year one hour of regulated sport exercise, including 15 min of endurance training. The pupils of the control group undertook customary sport activity (two hours a week). Anthropometric data were recorded and maximal oxygen uptake measured in each pupil, as well as blood pressure and motor coordination at the beginning and at the end of each of the two years of the study. The data were analyzed using the cluster randomization method. Maximal oxygen uptake (VO (2)max) had improved among the intervention group after two years, compared with the controls (3.12 m/kg/min, 95% confindence interval [CI] 0.06-6.19), while improvement in motor coordination just failed to reach statistical significance (3.06, 95% CI -0.17-6.29). There was no significant difference in systolic and diastolic blood pressure, but a downward trend in the prevalence of overweight and obesity from 12.1% to 7.8% in the intervention group. The results indicate that daily physical exercise during school hours should be given greater importance. But it will require a long-term trial to determine whether promotion of increased physical activity at school influences the prevalence of cardiovascular risk factors when the pupils reach adulthood. © Georg Thieme Verlag KG Stuttgart · New York.

  13. A controlled clinical trial of implant-retained mandibular overdentures : 10 years' results of clinical aspects and aftercare of IMZ implants and Branemark implants

    NARCIS (Netherlands)

    Meijer, HJA; Raghoebar, GM; Van't Hof, MA; Visser, A

    The aim of this prospective randomized controlled clinical trial was to evaluate the clinical outcomes and prosthetic aftercare of edentulous patients with a mandibular overdenture retained by two IMZ implants or two Branemark implants during a 10-year period. Patients were allocated to the IMZ

  14. Five year follow-up of a randomized controlled trial on warming and humidification of insufflation gas in laparoscopic colonic surgery--impact on small bowel obstruction and oncologic outcomes.

    Science.gov (United States)

    Sammour, Tarik; Hill, Andrew G

    2015-04-01

    Warming and humidification of insufflation gas has been shown to reduce adhesion formation and tumor implantation in the laboratory setting, but clinical evidence is lacking. We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced adhesion formation, and improve oncologic outcomes in laparoscopic colonic surgery. This was a 5-year follow-up of a multicenter, double-blinded, randomized, controlled trial investigating warming and humidification of insufflation gas. The study group received warmed (37°C), humidified (98%) insufflation carbon dioxide, and the control group received standard gas (19°C, 0%). All other aspects of patient care were standardized. Admissions for small bowel obstruction were recorded, as well as whether management was operative or nonoperative. Local and systemic cancer recurrence, 5-year overall survival, and cancer specific survival rates were also recorded. Eighty two patients were randomized, with 41 in each arm. Groups were well matched at baseline. There was no difference between the study and control groups in the rate of clinical small bowel obstruction (5.7% versus 0%, P 0.226); local recurrence (6.5% versus 6.1%, P 1.000); overall survival (85.7% versus 82.1%, P 0.759); or cancer-specific survival (90.3% versus 87.9%, P 1.000). Warming and humidification of insufflation CO2 in laparoscopic colonic surgery does not appear to confer a clinically significant long term benefit in terms of adhesion reduction or oncological outcomes, although a much larger randomized controlled trial (RCT) would be required to confirm this. ClinicalTrials.gov Trial identifier: NCT00642005; US National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894, USA.

  15. Five Year Follow-Up of a Randomized Controlled Trial on Warming and Humidification of Insufflation Gas in Laparoscopic Colonic Surgery—Impact on Small Bowel Obstruction and Oncologic Outcomes

    Science.gov (United States)

    Sammour, Tarik; Hill, Andrew G.

    2015-01-01

    Warming and humidification of insufflation gas has been shown to reduce adhesion formation and tumor implantation in the laboratory setting, but clinical evidence is lacking. We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced adhesion formation, and improve oncologic outcomes in laparoscopic colonic surgery. This was a 5-year follow-up of a multicenter, double-blinded, randomized, controlled trial investigating warming and humidification of insufflation gas. The study group received warmed (37°C), humidified (98%) insufflation carbon dioxide, and the control group received standard gas (19°C, 0%). All other aspects of patient care were standardized. Admissions for small bowel obstruction were recorded, as well as whether management was operative or nonoperative. Local and systemic cancer recurrence, 5-year overall survival, and cancer specific survival rates were also recorded. Eighty two patients were randomized, with 41 in each arm. Groups were well matched at baseline. There was no difference between the study and control groups in the rate of clinical small bowel obstruction (5.7% versus 0%, P 0.226); local recurrence (6.5% versus 6.1%, P 1.000); overall survival (85.7% versus 82.1%, P 0.759); or cancer-specific survival (90.3% versus 87.9%, P 1.000). Warming and humidification of insufflation CO2 in laparoscopic colonic surgery does not appear to confer a clinically significant long term benefit in terms of adhesion reduction or oncological outcomes, although a much larger randomized controlled trial (RCT) would be required to confirm this. ClinicalTrials.gov Trial identifier: NCT00642005; US National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894, USA. PMID:25875541

  16. Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2014.

    Science.gov (United States)

    Deane, Bryan R; Porkess, Sheuli

    2018-07-01

    The objective of this study was to assess the timely disclosure of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) during 2014. This is the final extension of three previously reported studies of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, and in 2012 and 2013. The original study found that over a three-year period over three-quarters of all trials were disclosed within 12 months and almost 90% were disclosed by the end of the study (31 January 2013). The extension studies (2012 and 2013 approvals) both showed an improvement in results disclosure within 12 months to 90%, and an overall disclosure rate of 92% and 93% respectively by the end of the studies. The methodology used was exactly as previously reported. Various publicly available information sources were searched for both clinical trial registration and disclosure of results. All completed company-sponsored trials related to each new medicine approved for marketing by the EMA in 2014, carried out in patients and recorded on a clinical trials registry and/or included in an EMA European Public Assessment Report (EPAR), were included. Information sources were searched between 1 May and 31 July 2016. The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 July 2016 (end of survey). Of the completed trials associated with 32 new medicines licensed to 22 different companies in 2014, results of 93% (505/542) had been disclosed within 12 months, and results of 96% (518/542) had been disclosed by 31 July 2016. The disclosure rate within 12 months of 93% suggests that industry is continuing to achieve disclosure in a timely manner. The overall disclosure rate at study end of 96% indicates that the improvement in transparency

  17. Decommissioning of AECL Whiteshell Laboratories: progress from first five years of legacy funding

    International Nuclear Information System (INIS)

    Swartz, R.S.; Bilinsky, D.M.; Harding, J.W.; Ridgway, W.R.

    2011-01-01

    In 2006, the Government of Canada adopted a new long-term strategy to deal with the nuclear legacy liabilities and initiated a five-year start-up phase. The objective is to safely and cost-effectively reduce these liabilities, and associated risks, based on sound waste management and environmental principles in the best interests of Canadians. AECL's Whiteshell Laboratories is part of the long-term strategy and decommissioning activities are underway. Several redundant non-nuclear buildings have been removed/decommissioned, and redundant nuclear facilities (hot cell facilities, radiochemical laboratories) are being decontaminated and prepared for demolition. This paper describes the progress in the first five-year funding period (2006 April to 2011 March). (author)

  18. The randomized shortened dental arch study: tooth loss over five years.

    Science.gov (United States)

    Walter, M H; Hannak, W; Kern, M; Mundt, T; Gernet, W; Weber, A; Wöstmann, B; Stark, H; Werner, D; Hartmann, S; Range, U; Jahn, F; Passia, N; Pospiech, P; Mitov, G; Brückner, J; Wolfart, S; Busche, E; Luthardt, R G; Heydecke, G; Marré, B

    2013-04-01

    The study was designed to provide clinical outcome data for two treatments of the shortened dental arch (SDA). In a multicenter randomized controlled clinical trial, patients with complete molar loss in one jaw were provided with either a partial removable dental prosthesis (PRDP) retained with precision attachments or treated according to the SDA concept preserving or restoring a premolar occlusion. No implants were placed. The primary outcome was tooth loss. Of 152 treated patients, 132 patients reached the 5-year examination. Over 5 years, 38 patients experienced tooth loss. For the primary outcome tooth loss, the Kaplan-Meier survival rates at 5 years were 0.74 (95% CI 0.64, 0.84) in the PRDP group and 0.74 (95% CI 0.63, 0.85) in the SDA group. For tooth loss in the study jaw, the survival rates at 5 years were 0.88 (95% CI 0.80, 0.95) in the PRDP group and 0.84 (95% CI 0.74, 0.93) in the SDA group. The differences were not significant. No Cox regression models of appropriate fit explaining tooth loss on the patient level could be found. The overall treatment goals of a sustainable oral rehabilitation and the avoidance of further tooth loss over longer periods were not reliably achievable. The influence of the type of prosthetic treatment on tooth loss might have been overestimated. Regarding our results, the patient's view will gain even more importance in the clinical decision between removable and fixed restorations in SDAs.

  19. Children under Five and Digital Technologies: Implications for Early Years Pedagogy

    Science.gov (United States)

    Palaiologou, Ioanna

    2016-01-01

    This project aimed to investigate the types of digital technologies children under the age of five are using at home and assess the possible implications for early years pedagogy. The research, carried out between 2010 and 2012, was based in four European countries: England, Greece, Malta and Luxemburg. A mixed methods approach was employed to…

  20. Use of insecticide-treated mosquito nets for children under five years ...

    African Journals Online (AJOL)

    2011-06-13

    Jun 13, 2011 ... Background: Insecticide-treated nets (ITNs) have proven to be one of the most effective means of reducing malaria morbidity and mortality in children and pregnant women. This study is carried out to determine the practice and determinants of ITN use for children under five years among care givers in an ...

  1. Community re-integration and long-term need in the first five years after stroke: results from a national survey.

    Science.gov (United States)

    Walsh, Mary Elizabeth; Galvin, Rose; Loughnane, Cliona; Macey, Chris; Horgan, N Frances

    2015-01-01

    Acute stroke care continues to improve but the later stroke recovery phase remains less well understood. The aim of this study was to document self-reported need in relation to stroke recovery and community re-integration among community-dwelling persons up to five years post-stroke. A national survey was carried out in Ireland. Participants were recruited through stroke advocacy organisations and health professionals. Existing validated questionnaires were adapted with permission. The final questionnaire assessed respondents' perceptions of their community re-integration and on-going needs. A total of 196 stroke survivors, aged 24-89 years responded. Over 75% of respondents reported experiencing mobility, emotional, fatigue and concentration difficulties post-stroke. Emotional problems and fatigue demonstrated the highest levels of unmet need. Families provided much support with 52% of people needing help with personal care post-stroke. Forty-two per cent of respondents in a relationship felt that it was significantly affected by their stroke. In addition, 60% of respondents reported negative financial change. Only 23% of those <66 years had worked since their stroke, while 60% of drivers returned to driving. Stroke had a personal, social and economic impact. Emotional distress and fatigue were common and satisfaction with the help available for these problems was poor. Implications for Rehabilitation Professionals should recognise that family members provide high levels of support post-stroke while dealing with changes to personal relationships. Emotional, concentration and fatigue problems post-stroke require recognition by health professionals. A greater focus on return-to-work as part of stroke rehabilitation may be of value for patients of working age.

  2. A five year prospective investigation of anterior pituitary function after traumatic brain injury: is hypopituitarism long-term after head trauma associated with autoimmunity?

    Science.gov (United States)

    Tanriverdi, Fatih; De Bellis, Annamaria; Ulutabanca, Halil; Bizzarro, Antonio; Sinisi, Antonio A; Bellastella, Giuseppe; Amoresano Paglionico, Vanda; Dalla Mora, Liliana; Selcuklu, Ahmed; Unluhizarci, Kursad; Casanueva, Felipe F; Kelestimur, Fahrettin

    2013-08-15

    Traumatic brain injury (TBI) has been recently recognized as a common cause of pituitary dysfunction. However, there are not sufficient numbers of prospective studies to understand the natural history of TBI induced hypopituitarism. The aim was to report the results of five years' prospective follow-up of anterior pituitary function in patients with mild, moderate and severe TBI. Moreover, we have prospectively investigated the associations between TBI induced hypopituitarism and presence of anti-hypothalamus antibodies (AHA) and anti-pituitary antibodies (APA). Twenty five patients (20 men, five women) were included who were prospectively evaluated 12 months and five years after TBI, and 17 of them also had a third-year evaluation. Growth hormone (GH) deficiency is the most common pituitary hormone deficit at one, three, and five years after TBI. Although most of the pituitary hormone deficiencies improve over time, there were substantial percentages of pituitary hormone deficiencies at the fifth year (28% GH, 4% adrenocorticotropic hormone [ACTH], and 4% gonadotropin deficiencies). Pituitary dysfunction was significantly higher in strongly AHA- and APA-positive (titers ≥1/16) patients at the fifth year. In patients with mild and moderate TBI, ACTH and GH deficiencies may improve over time in a considerable number of patients but, although rarely, may also worsen over the five-year period. However in severe TBI, ACTH and GH status of the patients at the first year evaluation persisted at the fifth year. Therefore, screening pituitary function after TBI for five years is important, especially in patients with mild TBI. Moreover, close strong associations between the presence of high titers of APA and/or AHA and hypopituitarism at the fifth year were shown for the first time.

  3. High dose melphalan in the treatment of advanced neuroblastoma: results of a randomised trial (ENSG-1) by the European Neuroblastoma Study Group.

    Science.gov (United States)

    Pritchard, Jon; Cotterill, Simon J; Germond, Shirley M; Imeson, John; de Kraker, Jan; Jones, David R

    2005-04-01

    High dose myeloablative chemotherapy ("megatherapy"), with haematopoietic stem cell support, is now widely used to consolidate response to induction chemotherapy in patients with advanced neuroblastoma. In this study (European Neuroblastoma Study Group, ENSG1), the value of melphalan myeloablative "megatherapy" was evaluated in a randomised, multi-centre trial. Between 1982 and 1985, 167 children with stages IV and III neuroblastoma (123 stage IV > 1 year old at diagnosis and 44 stage III and stage IV from 6 to 12 months old at diagnosis) were treated with oncovin, cisplatin, epipodophyllotoxin, and cyclophosphamide (OPEC) induction chemotherapy every 3 weeks. After surgical excision of primary tumour, the 90 patients (69% of the total) who achieved complete response (CR) or good partial response (GPR) were eligible for randomisation either to high dose melphalan (180 mg per square meter) with autologous bone marrow support or to no further treatment. Sixty-five (72%) of eligible children were actually randomised and 21 of these patients were surviving at time of this analysis, with median follow-up from randomisation of 14.3 years. Five year event-free survival (EFS) was 38% (95% confidence interval (CI) 21-54%) in the melphalan-treated group and 27% (95% CI 12-42%) in the "no-melphalan" group. This difference was not statistically significant (P = 0.08, log rank test) but for the 48 randomised stage IV patients aged >1 year at diagnosis outcome was significantly better in the melphalan-treated group-5 year EFS 33% versus 17% (P = 0.01, log rank test). In this trial, high dose melphalan improved the length of EFS and overall survival of children with stage IV neuroblastoma >1 year of age who achieved CR or GPR after OPEC induction therapy and surgery. Multi-agent myeloablative regimens are now widely used as consolidation therapy for children with stage IV disease and in those with other disease stages when the MYCN gene copy number in tumour cells is amplified

  4. The influence of repeated abutment changes on peri-implant tissue stability: 3-year post-loading results from a multicentre randomised controlled trial.

    Science.gov (United States)

    Bressan, Eriberto; Grusovin, Maria Gabriella; D'Avenia, Ferdinando; Neumann, Konrad; Sbricoli, Luca; Luongo, Giuseppe; Esposito, Marco

    increased marginal bone loss (difference = 0.1 mm, CI 95%: -0.3, 0.5, P = 0.590) or buccal recessions (difference = 0.1 mm, CI 95%: -0.4, 0.7, P = 0.674) at implants with less than 2 mm of keratinised mucosa at loading. Three-year post-loading data showed that repeated abutment disconnections significantly increased bone loss of 0.43 mm, but this difference may not be considered clinically relevant; therefore clinicians can use the procedure they find more convenient for each specific patient. Immediately non-occlusally loaded dental implants are a viable alternative to conventional loading and no increased bone loss or buccal recessions were noticed at implants with less than 2 mm of keratinised mucosa. Conflict of interest statement: This trial was partially funded by Dentsply Sirona Implants, the manufacturer of the implants and other products evaluated in this investigation. However, data belonged to the authors and by no means did the manufacturer interfere with the conduct of the trial or the publication of the results, with the exception of rejecting a proposal to change the protocol, after the trial was started, allowing the use of indexed abutments.

  5. A National Strategy to Develop Pragmatic Clinical Trials Infrastructure

    Science.gov (United States)

    Guise, Jeanne‐Marie; Dolor, Rowena J.; Meissner, Paul; Tunis, Sean; Krishnan, Jerry A.; Pace, Wilson D.; Saltz, Joel; Hersh, William R.; Michener, Lloyd; Carey, Timothy S.

    2014-01-01

    Abstract An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols. In 2012, we launched a 1‐year learning network to identify high‐priority pragmatic clinical trials and to deploy research infrastructure through the NIH Clinical and Translational Science Awards Consortium that could be used to launch and sustain them. The network and infrastructure were initiated as a learning ground and shared resource for investigators and communities interested in developing pragmatic clinical trials. We followed a three‐stage process of developing the network, prioritizing proposed trials, and implementing learning exercises that culminated in a 1‐day network meeting at the end of the year. The year‐long project resulted in five recommendations related to developing the network, enhancing community engagement, addressing regulatory challenges, advancing information technology, and developing research methods. The recommendations can be implemented within 24 months and are designed to lead toward a sustained national infrastructure for pragmatic trials. PMID:24472114

  6. Depression and anxiety in women with early breast cancer: five year observational cohort study

    Science.gov (United States)

    Burgess, Caroline; Cornelius, Victoria; Love, Sharon; Graham, Jill; Richards, Michael; Ramirez, Amanda

    2005-01-01

    Objective To examine the prevalence of, and risk factors for, depression and anxiety in women with early breast cancer in the five years after diagnosis. Design Observational cohort study. Setting NHS breast clinic, London. Participants 222 women with early breast cancer: 170 (77%) provided complete interview data up to either five years after diagnosis or recurrence. Main outcome measures Prevalence of clinically important depression and anxiety (structured psychiatric interview with standardised diagnostic criteria) and clinical and patient risk factors, including stressful life experiences (Bedford College life events and difficulties schedule). Results Nearly 50% of the women with early breast cancer had depression, anxiety, or both in the year after diagnosis, 25% in the second, third, and fourth years, and 15% in the fifth year. Point prevalence was 33% at diagnosis, falling to 15% after one year. 45% of those with recurrence experienced depression, anxiety, or both within three months of the diagnosis. Previous psychological treatment predicted depression, anxiety, or both in the period around diagnosis (one month before diagnosis to four months after diagnosis). Longer term depression and anxiety, were associated with previous psychological treatment, lack of an intimate confiding relationship, younger age, and severely stressful non-cancer life experiences. Clinical factors were not associated with depression and anxiety, at any time. Lack of intimate confiding support also predicted more protracted episodes of depression and anxiety. Conclusion Increased levels of depression, anxiety, or both in the first year after a diagnosis of early breast cancer highlight the need for dedicated service provision during this time. Psychological interventions for women with breast cancer who remain disease free should take account of the broader social context in which the cancer occurs, with a focus on improving social support. PMID:15695497

  7. Electricity supply alternatives : the next five years

    International Nuclear Information System (INIS)

    Oliver, W.J.

    1998-01-01

    Characteristics of the energy market for New England and the state of New York were summarized. It was predicted that in the next five years, virtually all proposals for electricity generation for New England and New York will be gas-fired combined cycle projects which are designed to meet new generation requirements and displace older steam units. The status of nuclear plants will influence project economics. It has been estimated that New England will need about 6,000-7,000 MW by 2004. This need is driven by the current deficiencies and increased shortfalls due to load growth and economic retirements of 2,000-4,000 MW. Market assumptions for new entrants, merchant plant economics, gas requirements in New England, pipeline capacity and power generation, and the challenges facing the natural gas industry were reviewed. A list of proposed combined cycle natural gas merchant power plants and their generating capacity was also provided. 1 tab., 5 figs

  8. Local Treatment of Unresectable Colorectal Liver Metastases: Results of a Randomized Phase II Trial.

    Science.gov (United States)

    Ruers, Theo; Van Coevorden, Frits; Punt, Cornelis J A; Pierie, Jean-Pierre E N; Borel-Rinkes, Inne; Ledermann, Jonathan A; Poston, Graeme; Bechstein, Wolf; Lentz, Marie-Ange; Mauer, Murielle; Folprecht, Gunnar; Van Cutsem, Eric; Ducreux, Michel; Nordlinger, Bernard

    2017-09-01

    Tumor ablation is often employed for unresectable colorectal liver metastases. However, no survival benefit has ever been demonstrated in prospective randomized studies. Here, we investigate the long-term benefits of such an aggressive approach. In this randomized phase II trial, 119 patients with unresectable colorectal liver metastases (n  38%) was met. We now report on long-term OS results. All statistical tests were two-sided. The analyses were according to intention to treat. At a median follow up of 9.7 years, 92 of 119 (77.3%) patients had died: 39 of 60 (65.0%) in the combined modality arm and 53 of 59 (89.8%) in the systemic treatment arm. Almost all patients died of progressive disease (35 patients in the combined modality arm, 49 patients in the systemic treatment arm). There was a statistically significant difference in OS in favor of the combined modality arm (hazard ratio [HR] = 0.58, 95% confidence interval [CI] = 0.38 to 0.88, P = .01). Three-, five-, and eight-year OS were 56.9% (95% CI = 43.3% to 68.5%), 43.1% (95% CI = 30.3% to 55.3%), 35.9% (95% CI = 23.8% to 48.2%), respectively, in the combined modality arm and 55.2% (95% CI = 41.6% to 66.9%), 30.3% (95% CI = 19.0% to 42.4%), 8.9% (95% CI = 3.3% to 18.1%), respectively, in the systemic treatment arm. Median OS was 45.6 months (95% CI = 30.3 to 67.8 months) in the combined modality arm vs 40.5 months (95% CI = 27.5 to 47.7 months) in the systemic treatment arm. This phase II trial is the first randomized study demonstrating that aggressive local treatment can prolong OS in patients with unresectable colorectal liver metastases. © The Author 2017. Published by Oxford University Press.

  9. The Results of a Randomized Control Trial Evaluation of the SPARK Literacy Program

    Science.gov (United States)

    Jones, Curtis J.; Christian, Michael; Rice, Andrew

    2016-01-01

    The purpose of this report is to present the results of a two-year randomized control trial evaluation of the SPARK literacy program. SPARK is an early grade literacy program developed by Boys & Girls Clubs of Greater Milwaukee. In 2010, SPARK was awarded an Investing in Innovation (i3) Department of Education grant to further develop the…

  10. Five-Year Biochemical Results, Toxicity, and Patient-Reported Quality of Life After Delivery of Dose-Escalated Image Guided Proton Therapy for Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Bryant, Curtis, E-mail: cbryant@floridaproton.org [University of Florida Health Proton Therapy Institute, Jacksonville, Florida (United States); Smith, Tamara L.; Henderson, Randal H.; Hoppe, Bradford S.; Mendenhall, William M.; Nichols, R. Charles; Morris, Christopher G. [University of Florida Health Proton Therapy Institute, Jacksonville, Florida (United States); Williams, Christopher R. [Department of Urology, University of Florida College of Medicine, Jacksonville, Florida (United States); Su, Zhong; Li, Zuofeng; Lee, Derek; Mendenhall, Nancy P. [University of Florida Health Proton Therapy Institute, Jacksonville, Florida (United States)

    2016-05-01

    Purpose: To report clinical outcomes in patients treated with image guided proton therapy (PT) for localized prostate cancer. Methods and Materials: The medical records of 1327 men were reviewed. Each man was enrolled on an outcomes tracking study. Dual enrollment on a prospective clinical trial was allowed. Each patient was treated for localized prostate cancer with PT at our institution between 2006 and 2010. Ninety-eight percent of patients received 78 Gy (radiobiological equivalent [RBE]) or higher; 18% received androgen deprivation therapy (ADT). The 5-year freedom from biochemical progression (FFBP), distant metastasis-free survival, and cause-specific survival rates are reported for each risk group. Data on patient-reported quality of life and high-grade toxicities were prospectively collected and reported. A multivariate analysis was performed to identify clinical predictors of biochemical failure and urologic toxicity. Results: The median follow-up time was 5.5 years. The 5-year FFBP rates were 99%, 94%, and 74% in low-risk, intermediate-risk, and high-risk patients, respectively. The actuarial 5-year rates of late grade 3+ Common Terminology Criteria for Adverse Events, version 4.0, gastrointestinal (GI) and genitourinary (GU) toxicity were 0.6% and 2.9%, respectively. Multivariate analysis showed a significant correlation between grade 3+ GU toxicity and pretreatment prostate reductive procedures (P<.0001), prostate volume (P=.0085), pretreatment α-blockers (P=.0067), diabetes (P=.0195), and dose–volume histogram parameters (P=.0208). The median International Prostate Symptom Scores pretreatment scores and scores at 5 years after treatment were 7 and 7, respectively. The mean Expanded Prostate Cancer Index Composite (EPIC) scores significantly declined for sexual summary for patients not receiving ADT (from 67 to 53) between baseline and 5 years. Conclusions: Image guided PT provided excellent biochemical control rates for patients with

  11. Five-Year Biochemical Results, Toxicity, and Patient-Reported Quality of Life After Delivery of Dose-Escalated Image Guided Proton Therapy for Prostate Cancer

    International Nuclear Information System (INIS)

    Bryant, Curtis; Smith, Tamara L.; Henderson, Randal H.; Hoppe, Bradford S.; Mendenhall, William M.; Nichols, R. Charles; Morris, Christopher G.; Williams, Christopher R.; Su, Zhong; Li, Zuofeng; Lee, Derek; Mendenhall, Nancy P.

    2016-01-01

    Purpose: To report clinical outcomes in patients treated with image guided proton therapy (PT) for localized prostate cancer. Methods and Materials: The medical records of 1327 men were reviewed. Each man was enrolled on an outcomes tracking study. Dual enrollment on a prospective clinical trial was allowed. Each patient was treated for localized prostate cancer with PT at our institution between 2006 and 2010. Ninety-eight percent of patients received 78 Gy (radiobiological equivalent [RBE]) or higher; 18% received androgen deprivation therapy (ADT). The 5-year freedom from biochemical progression (FFBP), distant metastasis-free survival, and cause-specific survival rates are reported for each risk group. Data on patient-reported quality of life and high-grade toxicities were prospectively collected and reported. A multivariate analysis was performed to identify clinical predictors of biochemical failure and urologic toxicity. Results: The median follow-up time was 5.5 years. The 5-year FFBP rates were 99%, 94%, and 74% in low-risk, intermediate-risk, and high-risk patients, respectively. The actuarial 5-year rates of late grade 3+ Common Terminology Criteria for Adverse Events, version 4.0, gastrointestinal (GI) and genitourinary (GU) toxicity were 0.6% and 2.9%, respectively. Multivariate analysis showed a significant correlation between grade 3+ GU toxicity and pretreatment prostate reductive procedures (P<.0001), prostate volume (P=.0085), pretreatment α-blockers (P=.0067), diabetes (P=.0195), and dose–volume histogram parameters (P=.0208). The median International Prostate Symptom Scores pretreatment scores and scores at 5 years after treatment were 7 and 7, respectively. The mean Expanded Prostate Cancer Index Composite (EPIC) scores significantly declined for sexual summary for patients not receiving ADT (from 67 to 53) between baseline and 5 years. Conclusions: Image guided PT provided excellent biochemical control rates for patients with

  12. FIVE-YEAR OUTCOMES AFTER LONG-TERM OXANDROLONE ADMINISTRATION IN SEVERELY BURNED CHILDREN: A RANDOMIZED CLINICAL TRIAL.

    Science.gov (United States)

    Reeves, Patrick T; Herndon, David N; Tanksley, Jessica D; Jennings, Kristofer; Klein, Gordon L; Mlcak, Ronald P; Clayton, Robert P; Crites, Nancy N; Hays, Joshua P; Andersen, Clark; Lee, Jong O; Meyer, Walter; Suman, Oscar E; Finnerty, Celeste C

    2016-04-01

    administration for 12 months. Additionally, fewer patients in the oxandrolone cohort met the diagnostic criteria for pediatric osteoporosis, pointing to a reduced risk for future bone fracture. This study demonstrates that administering oxandrolone for up to 2 years following severe burn injury results in greater improvements in BMC, BMD, and height velocity.

  13. Results of 2-year vitamin B treatment on cognitive performance

    NARCIS (Netherlands)

    Zwaluw, van der N.L.; Dhonukshe-Rutten, R.A.M.; Wijngaarden, van J.P.; Brouwer, E.M.; Rest, van de O.; Veld, in 't P.H.; Enneman, A.W.; Dijk, van S.C.; Ham, A.C.; Swart, K.M.A.; Velde, van der N.; Schoor, van N.M.; Cammen, van der T.J.M.; Uitterlinden, A.G.; Lips, P.; Kessels, R.P.C.; Groot, de C.P.G.M.

    2014-01-01

    Objective: We investigated the effects of 2-year folic acid and vitamin B12 supplementation on cognitive performance in elderly people with elevated homocysteine (Hcy) levels. Methods: This multicenter, double-blind, randomized, placebo-controlled trial included 2,919 elderly participants (65 years

  14. Sexual Function After Stereotactic Body Radiotherapy for Prostate Cancer: Results of a Prospective Clinical Trial

    International Nuclear Information System (INIS)

    Wiegner, Ellen A.; King, Christopher R.

    2010-01-01

    Purpose: To study the sexual quality of life for prostate cancer patients after stereotactic body radiotherapy (SBRT). Methods and Materials: Using the Expanded Prostate Cancer Index Composite (EPIC)-validated quality-of-life questionnaire, the sexual function of 32 consecutive patients who received prostate SBRT in a prospective Phase II clinical trial were analyzed at baseline, and at median times of 4, 12, 20, and 50 months after treatment. SBRT consisted of 36.25 Gy in five fractions of 7.25 Gy using the Cyberknife. No androgen deprivation therapy was given. The use of erectile dysfunction (ED) medications was monitored. A comprehensive literature review for radiotherapy-alone modalities based on patient self-reported questionnaires served as historical comparison. Results: Median age at treatment was 67.5 years, and median follow-up was 35.5 months (minimum 12 months). The mean EPIC sexual domain summary score, sexual function score, and sexual bother score decreased by 45%, 49%, and 25% respectively at 50 months follow-up. These differences reached clinical relevance by 20 months after treatment. Baseline ED rate was 38% and increased to 71% after treatment (p = 0.024). Use of ED medications was 3% at baseline and progressed to 25%. For patients aged <70 years at follow-up, 60% maintained satisfactory erectile function after treatment compared with only 12% aged ≥70 years (p = 0.008). Penile bulb dose was not associated with ED. Conclusions: The rates of ED after treatment appear comparable to those reported for other modalities of radiotherapy. Given the modest size of this study and the uncertainties in the physiology of radiotherapy-related ED, these results merit further investigations.

  15. Cervical spine disease may result in a negative lumbar spinal drainage trial in normal pressure hydrocephalus: case report.

    Science.gov (United States)

    Komotar, Ricardo J; Zacharia, Brad E; Mocco, J; Kaiser, Michael G; Frucht, Stephen J; McKhann, Guy M

    2008-10-01

    In this case report, we present a patient with normal pressure hydrocephalus in whom a lumbar drainage trial yielded a false-negative result secondary to cervical spondylosis. An 80-year-old woman presented with classic symptoms of normal pressure hydrocephalus as well as evidence of cervical myelopathy. Magnetic resonance imaging of the brain and spine showed enlarged ventricles and single-level cervical canal narrowing. An initial lumbar drainage trial was performed, which revealed negative results. The patient then underwent cervical decompression and fusion. Despite this procedure, the patient's symptoms continued to worsen. A repeat lumbar drainage trial was performed with positive results. Subsequently, a ventriculoperitoneal shunt was placed, resulting in significant improvement of her symptoms. This case report illustrates how altered cerebrospinal fluid flow dynamics may impact the accuracy of the lumbar spinal drainage trial in patients with normal pressure hydrocephalus.

  16. Caries in five-year-old children and associations with family-related factors.

    Science.gov (United States)

    Mattila, M L; Rautava, P; Sillanpää, M; Paunio, P

    2000-03-01

    It is generally understood that the teeth of pre-school-aged children are healthy, but the improvement in the dmft index has halted in the industrialized countries. Those few children who have caries have more of it than before. Little is known of the family-related factors which are associated with this polarization of caries. A representative population-based sample consisted of 1443 mothers expecting their first child. The children were followed at well-baby clinics and public dental health clinics for over five years. The objective was to study the prevalence of dental caries and its predictors in five-year-old children and to assess children's own dental health habits and the meaning of family-related factors in dental health. The findings were based on questionnaire data from parents and on clinical dental examinations of the five-year-old children as completed by 101 public health dentists. In firstborn five-year-old children, dental health was found to be good in 72%, fair in 20%, and poor in 8% of the cases. The final multivariate analysis illustrated that the dmft index > 0 was independently associated with the mother's irregular toothbrushing (OR 2.2; 95% CI 1.4-3.5), annual occurrence of several carious teeth in the father (OR 2.6; 95% CI 1.9-3.6), daily sugar consumption at the age of 18 months (OR 2.4; 95% CI 1.4-4.1), occurrence of child's headaches (OR 3.7; 95% CI 1.5-8.8), parents' cohabitation (OR 3.3; 95% CI 1.5-7.6), rural domicile (OR 2.4; 95% CI 1.2-4.5), and mother's young age (OR 5.0; 95% CI 1.3-19.8). The findings indicated that attention should be paid not only to the child's dental health care but also to that of the whole family. Parents should be supported in their upbringing efforts and encouraged to improve their children's dental health habits. In everyday life, parents function as role models for their children, and therefore, parents' own dental hygiene habits are very meaningful.

  17. SNL Five-Year Facilities & Infrastructure Plan FY2015-2019

    Energy Technology Data Exchange (ETDEWEB)

    Cipriani, Ralph J. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2014-12-01

    Sandia’s development vision is to provide an agile, flexible, safer, more secure, and efficient enterprise that leverages the scientific and technical capabilities of the workforce and supports national security requirements in multiple areas. Sandia’s Five-Year Facilities & Infrastructure Planning program represents a tool to budget and prioritize immediate and short-term actions from indirect funding sources in light of the bigger picture of proposed investments from direct-funded, Work for Others and other funding sources. As a complementary F&I investment program, Sandia’s indirect investment program supports incremental achievement of the development vision within a constrained resource environment.

  18. Fourteen-Year Long-Term Results after Gastric Banding

    Directory of Open Access Journals (Sweden)

    Christine Stroh

    2011-01-01

    Full Text Available Background. Gastric banding (GB is a common bariatric procedure that is performed worldwide. Weight loss can be substantial after this procedure, but it is not sufficient in a significant portion of patients. Long-term rates for associated complications increase with every year of follow up, and only a few long-term studies have been published that examine these rates. We present our results after 14 years of postoperative follow up. Methods. Two hundred patients were operated upon form 01.02.1995 to 31.01.2009. Data collection was performed prospectively. In retrospective analysis, we analyzed weight loss, short- and long-term complications, amelioration of comorbidities and long-term outcome. Results. The mean postoperative follow up time was 94.4 months (range 2–144. The follow up rate was 83.5%. The incidence of postoperative complications for slippage was 2.5%, for pouch dilatation was 9.5%, for band migration was 5.5% and 12.0% for overall band removal. After 14 years, the reoperation rate was 30.5% with a reoperation rate of 2.2% for every year of follow up. Excess weight loss was 40.2% after 1 year, 46.3% after 2 years, 45.9% after 3 years, 41.9% after five years, 33.3% after 8 years, 30.8% after 10 years, 33.3% after 12 years and 15.6% after 14 years of follow up. Conclusion. The complication and reoperation rate after GB is high. Nevertheless, GB is still a therapeutic option in morbid obese patients, but the criteria for patient selection should be carefully evaluated.

  19. Trends in all-cause five-year mortality after head and neck cancers diagnosed over a period of 33 years. Focus on estimated degree of association with human papillomavirus

    DEFF Research Database (Denmark)

    Svahn, Malene F; Munk, Christian; Nielsen, Thor S S

    2016-01-01

    . Furthermore, we examine whether any trend over time differed according to sex, stage, and age at diagnosis. RESULTS: All-cause five-year mortality after HNSCC has decreased over time. The greatest decrease was seen in the last decade (2000-2010) among patients with HNSCC at sites estimated to be strongly......-based cohort study of all 20 925 individuals diagnosed with squamous cell carcinoma of the head and neck (HNSCC) in Denmark 1978-2010, we investigate secular trends in all-cause five-year mortality after HNSCC according to the anticipated degree of association with HPV using a Cox proportional hazards model...... associated with HPV, i.e. the base of the tongue and the tonsils, where a 28% decrease per five years (e.g. HRbase of tongue/tonsils=0.72; 95% CI 0.64-0.81) was observed. When examining sex- and age-specific time trends, the decrease in mortality was most pronounced among male patients and patients below 60...

  20. Quality of Life From Canadian Cancer Trials Group MA.17R: A Randomized Trial of Extending Adjuvant Letrozole to 10 Years

    Science.gov (United States)

    Brundage, Michael D.; Parulekar, Wendy R.; Goss, Paul E.; Ingle, James N.; Pritchard, Kathleen I.; Celano, Paul; Muss, Hyman; Gralow, Julie; Strasser-Weippl, Kathrin; Whelan, Kate; Tu, Dongsheng; Whelan, Timothy J.

    2018-01-01

    Purpose MA.17R was a Canadian Cancer Trials Group–led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor as adjuvant therapy for hormone receptor–positive breast cancer. Quality of life (QOL) was a secondary outcome measure of the study, and here, we report the results of these analyses. Methods QOL was measured using the Short Form-36 (SF-36; two summary scores and eight domains) and menopause-specific QOL (MENQOL; four symptom domains) at baseline and every 12 months up to 60 months. QOL assessment was mandatory for Canadian Cancer Trials Group centers but optional for centers in other groups. Mean change scores from baseline were calculated. Results One thousand nine hundred eighteen women were randomly assigned, and 1,428 women completed the baseline QOL assessment. Compliance with QOL measures was > 85%. Baseline summary scores for the SF-36 physical component summary (47.5 for letrozole and 47.9 for placebo) and mental component summary (55.5 for letrozole and 54.8 for placebo) were close to the population norms of 50. No differences were seen between groups in mean change scores for the SF-36 physical and mental component summaries and the other eight QOL domains except for the role-physical subscale. No difference was found in any of the four domains of the MENQOL Conclusion No clinically significant differences were seen in overall QOL measured by the SF-36 summary measures and MENQOL between the letrozole and placebo groups. The data indicate that continuation of aromatase inhibitor therapy after 5 years of prior treatment in the trial population was not associated with a deterioration of overall QOL. PMID:29328860

  1. Quality of Life From Canadian Cancer Trials Group MA.17R: A Randomized Trial of Extending Adjuvant Letrozole to 10 Years.

    Science.gov (United States)

    Lemieux, Julie; Brundage, Michael D; Parulekar, Wendy R; Goss, Paul E; Ingle, James N; Pritchard, Kathleen I; Celano, Paul; Muss, Hyman; Gralow, Julie; Strasser-Weippl, Kathrin; Whelan, Kate; Tu, Dongsheng; Whelan, Timothy J

    2018-02-20

    Purpose MA.17R was a Canadian Cancer Trials Group-led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor as adjuvant therapy for hormone receptor-positive breast cancer. Quality of life (QOL) was a secondary outcome measure of the study, and here, we report the results of these analyses. Methods QOL was measured using the Short Form-36 (SF-36; two summary scores and eight domains) and menopause-specific QOL (MENQOL; four symptom domains) at baseline and every 12 months up to 60 months. QOL assessment was mandatory for Canadian Cancer Trials Group centers but optional for centers in other groups. Mean change scores from baseline were calculated. Results One thousand nine hundred eighteen women were randomly assigned, and 1,428 women completed the baseline QOL assessment. Compliance with QOL measures was > 85%. Baseline summary scores for the SF-36 physical component summary (47.5 for letrozole and 47.9 for placebo) and mental component summary (55.5 for letrozole and 54.8 for placebo) were close to the population norms of 50. No differences were seen between groups in mean change scores for the SF-36 physical and mental component summaries and the other eight QOL domains except for the role-physical subscale. No difference was found in any of the four domains of the MENQOL Conclusion No clinically significant differences were seen in overall QOL measured by the SF-36 summary measures and MENQOL between the letrozole and placebo groups. The data indicate that continuation of aromatase inhibitor therapy after 5 years of prior treatment in the trial population was not associated with a deterioration of overall QOL.

  2. Community-based interventions for enhancing access to or consumption of fruit and vegetables among five to 18-year olds: a scoping review

    Directory of Open Access Journals (Sweden)

    Ganann Rebecca

    2012-08-01

    Full Text Available Abstract Background Low fruit and vegetable ( FV consumption is a key risk factor for morbidity and mortality. Consumption of FV is limited by a lack of access to FV. Enhanced understanding of interventions and their impact on both access to and consumption of FV can provide guidance to public health decision-makers. The purpose of this scoping review is to identify and map literature that has evaluated effects of community-based interventions designed to increase FV access or consumption among five to 18-year olds. Methods The search included 21 electronic bibliographic databases, grey literature, targeted organization websites, and 15 key journals for relevant studies published up to May 2011. Retrieved citations were screened in duplicate for relevance. Data extracted from included studies covered: year, country, study design, target audience, intervention setting, intervention strategies, interventionists, and reported outcomes. Results The search located 19,607 unique citations. Full text relevance screening was conducted on 1,908 studies. The final 289 unique studies included 30 knowledge syntheses, 27 randomized controlled trials, 55 quasi-experimental studies, 113 cluster controlled studies, 60 before-after studies, one mixed method study, and three controlled time series studies. Of these studies, 46 included access outcomes and 278 included consumption outcomes. In terms of target population, 110 studies focused on five to seven year olds, 175 targeted eight to 10 year olds, 192 targeted 11 to 14 year olds, 73 targeted 15 to 18 year olds, 55 targeted parents, and 30 targeted teachers, other service providers, or the general public. The most common intervention locations included schools, communities or community centres, and homes. Most studies implemented multi-faceted intervention strategies to increase FV access or consumption. Conclusions While consumption measures were commonly reported, this review identified a small yet

  3. Rural Transformation and Planning Tactics in the 13th Five-Year Plan Period

    Institute of Scientific and Technical Information of China (English)

    Luo; Xiaolong; Xu; Xiao; Li; Min

    2016-01-01

    Rural development has long been the focus of China’s central and local governments. Since the late 2000 s, rural areas have presented new transformation features and development trends. To stimulate rural transformation and development in the 13 th Five-Year Plan period, this paper reviews major ideas on rural development in related disciplines. This study also summarizes main rural transformation features, including the aging population, hollow villages, changes in the allocation of land resource, semi-urbanization, and regional differences in rural development. Finally, it also provides suggestions for planning tactics in the 13 th Five-Year Plan period, such as making differentiated rural development strategies, exploring new methods to stimulate rural stock land planning and use, and enforcing relevant policy and management reforms.

  4. Rural Transformation and Planning Tactics in the 13th Five-Year Plan Period

    Institute of Scientific and Technical Information of China (English)

    Luo Xiaolong; Xu Xiao; Li Min

    2016-01-01

    Rural development has long been the focus of China's central and local governments.Since the late 2000s,rural areas have presented new transformation features and development trends.To stimulate rural transformation and development in the 13th Five-Year Plan period,this paPer reviews major ideas on rural development in related disciplines.This study also summarizes main rural transformation features,including the aging population,hollow villages,changes in the allocation of land resource,semi-urbanization,and regional differences in rural development.Finally,it also provides suggestions for planning tactics in the 13th Five-Year Plan period,such as making differentiated rural development strategies,exploring new methods to stimulate rural stock land planning and use,and enforcing relevant policy and management reforms.

  5. Financial Management of a Large Multi-site Randomized Clinical Trial

    Science.gov (United States)

    Sheffet, Alice J.; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E.; Longbottom, Mary E.; Howard, Virginia J.; Marler, John R.; Brott, Thomas G.

    2014-01-01

    Background The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years’ funding ($21,112,866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2,500 randomized participants at 40 sites. Aims Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Methods Projections of the original grant’s fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant’s fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Results Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2,500 targeted sample size, 138 (5.5%) were randomized during the first five years and 1,387 (55.5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13,845) of the projected per-patient costs ($152,992) of the fixed model. Conclusions Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. PMID:24661748

  6. Five years program execution outcome; Bilan d'execution du plan quinquenal

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1983-07-01

    This document presents realized activities during five years program in mine field and petroleum (1979-1983). It involves mining and petroleum researches and mining productions. [French] Le document presente les activites realisees dans le domaine des mines et du petrole pendant les 5 annees du plan quinquenal (1979-1983). Il s'agit des recherches minieres et petrolieres et des productions minieres.

  7. Long-Term Sustainability of Evidence-Based Prevention Interventions and Community Coalitions Survival: a Five and One-Half Year Follow-up Study.

    Science.gov (United States)

    Johnson, Knowlton; Collins, David; Shamblen, Steve; Kenworthy, Tara; Wandersman, Abraham

    2017-07-01

    This study examines (1) coalition survival, (2) prevalence of evidence-based prevention interventions (EBPIs) to reduce substance abuse implemented as part of the Tennessee Strategic Prevention Framework (SPF) State Incentive Grant (SIG), (3) EBPI sustainability, and (4) factors that predict EBPI sustainability. Secondary data were collected on 27 SPF SIG-funded coalitions and 88 EBPI and non-EBPI implementations. Primary data were collected by a telephone interview/web survey five and one-half years after the SPF SIG ended. Results from secondary data show that 25 of the 27 coalitions survived beyond the SPF SIG for one to five and one-half years; 19 coalitions (70%) were still active five and one-half years later. Further, 88 EBPIs and non-EBPIs were implemented by 27 county SPF SIG coalitions. Twenty-one (21) of 27 coalitions (78%) implemented one to three EBPIs, totaling 37 EBPI implementations. Based on primary survey data on 29 of the 37 EBPI implementations, 28 EBPIs (97%) were sustained between two and five and one-half years while 22 EBPI implementations (76%) were sustained for five and one-half years. When controlling for variability among coalitions (nesting of EBPIs in coalitions), increases in data resources (availability of five types of prevention data) was a strong predictor of length of EBPI sustainability. Positive change in extramural funding resources and level of expertise during SPF SIG implementation, as well as level of coalition formalization at the end of the SPF SIG predicted EBPI sustainability length. One intervention attribute (trialability) also predicted length of sustainability. Implications are discussed.

  8. Surgical management of stress urinary incontinence in women: safety, effectiveness and cost-utility of trans-obturator tape (TOT versus tension-free vaginal tape (TVT five years after a randomized surgical trial

    Directory of Open Access Journals (Sweden)

    Eliasziw Misha

    2011-07-01

    Full Text Available Abstract Background We recently completed a randomized clinical trial of two minimally invasive surgical procedures for stress urinary incontinence, the retropubic tension-free vaginal tape (TVT versus the trans-obturator tape (TOT procedure. At one year postoperatively, we were concerned to find that a significant number of women had tape that was palpable when a vaginal examination was undertaken. Because the risk factors for adverse outcomes of tape surgery are not clearly understood, we are unable to say whether palpable tapes will lead to vaginal erosions or whether they merge into vaginal tissue. We do not know whether patients go on to have further adverse consequences of surgery, leading to additional cost to patients and healthcare system. Our current study is a 5 year follow-up of the women who took part in our original trial. Methods/Design All 199 women who participated in our original trial will be contacted and invited to take part in the follow-up study. Consenting women will attend a clinic visit where they will have a physical examination to identify vaginal erosion or other serious adverse outcomes of surgery, undertake a standardized pad test for urinary incontinence, and complete several health-related quality of life questionnaires (15D, UDI-6, IIQ-7. Analyses will compare the outcomes for women in the TOT versus TVT groups. The cost-effectiveness of TOT versus TVT over the 5 years after surgery, will be assessed with the use of disease-specific health service administrative data and an objective health outcome measure. A cost-utility analysis may also be undertaken, based on economic modeling, data from the clinical trial and inputs obtained from published literature. Discussion This study is needed now, because TOT and TVT are among the most frequently conducted surgical procedures for stress urinary incontinence in Canada. Because stress urinary incontinence is so common, the impact of selecting an approach that causes

  9. Surgical management of stress urinary incontinence in women: safety, effectiveness and cost-utility of trans-obturator tape (TOT) versus tension-free vaginal tape (TVT) five years after a randomized surgical trial

    Science.gov (United States)

    2011-01-01

    Background We recently completed a randomized clinical trial of two minimally invasive surgical procedures for stress urinary incontinence, the retropubic tension-free vaginal tape (TVT) versus the trans-obturator tape (TOT) procedure. At one year postoperatively, we were concerned to find that a significant number of women had tape that was palpable when a vaginal examination was undertaken. Because the risk factors for adverse outcomes of tape surgery are not clearly understood, we are unable to say whether palpable tapes will lead to vaginal erosions or whether they merge into vaginal tissue. We do not know whether patients go on to have further adverse consequences of surgery, leading to additional cost to patients and healthcare system. Our current study is a 5 year follow-up of the women who took part in our original trial. Methods/Design All 199 women who participated in our original trial will be contacted and invited to take part in the follow-up study. Consenting women will attend a clinic visit where they will have a physical examination to identify vaginal erosion or other serious adverse outcomes of surgery, undertake a standardized pad test for urinary incontinence, and complete several health-related quality of life questionnaires (15D, UDI-6, IIQ-7). Analyses will compare the outcomes for women in the TOT versus TVT groups. The cost-effectiveness of TOT versus TVT over the 5 years after surgery, will be assessed with the use of disease-specific health service administrative data and an objective health outcome measure. A cost-utility analysis may also be undertaken, based on economic modeling, data from the clinical trial and inputs obtained from published literature. Discussion This study is needed now, because TOT and TVT are among the most frequently conducted surgical procedures for stress urinary incontinence in Canada. Because stress urinary incontinence is so common, the impact of selecting an approach that causes more adverse events, or is

  10. One-year results of total arterial revascularization vs. conventional coronary surgery: CARRPO trial

    DEFF Research Database (Denmark)

    Damgaard, Sune; Wetterslev, Jørn; Lund, Jens T

    2009-01-01

    +/- 18% in the conventional group (P = 0.52). In 72% of TAR patients and 67% of the conventional group, all grafts were patent (P = 0.45). Multiple imputation of missing angiographic data did not influence on results. Within 1 year, 37 (23%) TAR patients and 43 (25%) conventional group patients suffered...... cardiac events (HR 1.09, 95% CI 0.70-1.69, P = 0.70). One patient (0.6%) in the TAR group and two (1.2%) in the conventional group died (P = 1.00). CONCLUSION: Within 1 year post-operatively, TAR seems at least as safe and effective as CR. Prolonged follow-up will reveal whether this is sustained......AIMS: To investigate clinical and angiographic outcomes after coronary surgery using total arterial revascularization (TAR). METHODS AND RESULTS: We randomized 331 patients with multivessel or isolated left main disease to TAR [internal thoracic (ITA) and radial arteries] vs. conventional...

  11. Grey literature in meta-analyses of randomized trials of health care interventions.

    Science.gov (United States)

    Hopewell, S; McDonald, S; Clarke, M; Egger, M

    2007-04-18

    The inclusion of grey literature (i.e. literature that has not been formally published) in systematic reviews may help to overcome some of the problems of publication bias, which can arise due to the selective availability of data. To review systematically research studies, which have investigated the impact of grey literature in meta-analyses of randomized trials of health care interventions. We searched the Cochrane Methodology Register (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to 20 May 2005), the Science Citation Index (June 2005) and contacted researchers who may have carried out relevant studies. A study was considered eligible for this review if it compared the effect of the inclusion and exclusion of grey literature on the results of a cohort of meta-analyses of randomized trials. Data were extracted from each report independently by two reviewers. The main outcome measure was an estimate of the impact of trials from the grey literature on the pooled effect estimates of the meta-analyses. Information was also collected on the area of health care, the number of meta-analyses, the number of trials, the number of trial participants, the year of publication of the trials, the language and country of publication of the trials, the number and type of grey and published literature, and methodological quality. Five studies met the inclusion criteria. All five studies showed that published trials showed an overall greater treatment effect than grey trials. This difference was statistically significant in one of the five studies. Data could be combined for three of the five studies. This showed that, on average, published trials showed a 9% greater treatment effect than grey trials (ratio of odds ratios for grey versus published trials 1.09; 95% CI 1.03-1.16). Overall there were more published trials included in the meta-analyses than grey trials (median 224 (IQR 108-365) versus 45(IQR 40-102)). Published trials had more participants on average. The most

  12. Sample selection may bias the outcome of an adolescent mental health survey: results from a five-year follow-up of 4171 adolescents.

    Science.gov (United States)

    Kekkonen, V; Kivimäki, P; Valtonen, H; Hintikka, J; Tolmunen, T; Lehto, S M; Laukkanen, E

    2015-02-01

    The representativeness of the data is one of the main issues in evaluating the significance of research findings. Dropping out is common in adolescent mental health research, and may distort the results. Nevertheless, very little is known about the types of systematic bias that may affect studies in a) the informed consent phase and b) later in follow-up phases. The authors addressed this gap in knowledge in a five-year follow-up study on a sample of adolescents aged 13-18 years. The data were collected using self-report questionnaires. The baseline sample consisted of 4171 adolescents, 1827 (43.8%) of whom gave consent to be contacted for a follow-up survey, but only 797 (19.1%) participated in the follow-up. Binary logistic regression models were used to explain the participation. Young age, female gender, a high number of hobbies, good performance at school in the native language and general subjects, family disintegration such as divorce, high parental employment, and symptoms of depression and anxiety were associated with both consent and participation. However, the effect of mental health aspects was smaller than the effect of age and gender. This study confirmed the possibility of systematic selection bias by adolescents' sociodemographic characteristics. The representativeness of the study sample might have been improved by more intense recruitment strategies. Copyright © 2014 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

  13. Validity of self-reported criminal justice system involvement in substance abusing women at five-year follow-up

    Directory of Open Access Journals (Sweden)

    Hesse Morten

    2008-01-01

    Full Text Available Abstract Background Few studies have compared self-reported criminal behaviour with high-quality databases of criminal offences and judicial sanctions. Self-reported problems from drug abusers are generally believed to be valid. We assessed the validity of self-reported theft, drug offences and prison sentences from a five-year follow-up of female substance abusers who were originally treated in a compulsory care unit in Lund, run by the Swedish Board of Institutional Care. Methods Data from a total of 106 of a consecutive sample of 132 women inter-viewed in a five-year follow-up. All were thoroughly assessed for somatic complaints, psychiatric and psychological problems, background factors with standardized instruments. Data over the five years were linked to official records of judicial sanctions, retrieved from The National Council for Crime Prevention, Stockholm, Sweden. Register data have a full cover for the whole cohort. The current data base contain full data back to 1975 up to 2004. Results Agreement was assessed for each year, as well as for the total period. Statistical control was performed for other types of crimes and prison. Although statistically significant, agreement was modest, and in contrast to previous studies, patients under-reported violence charges. Conclusion The findings suggest that self-reports of criminal behaviour from women can be used with some caution, and that the validity of self-report may vary between types of criminal justice system involvement.

  14. Career Decision Status as a Predictor of Resignation Behavior Five Years Later

    Science.gov (United States)

    Earl, Joanne K.; Minbashian, Amirali; Sukijjakhamin, Aun; Bright, Jim E. H.

    2011-01-01

    This paper extends earlier research exploring the relationship between career decision status and work outcomes by examining resignation behavior in a group of new graduates five years after initial appointment. On appointment various measures were collected including career decision status variables. Earlier research identified a significant…

  15. Double cervix in a five-year-old white Fulami cow | Ajala | African ...

    African Journals Online (AJOL)

    A case report of true double cervix in a five-year-old white Fulani cow is presented. The condition is known to cause infertility which might be the reason why the cow was brought to the slaughterhouse at this critical age. Keywords: Double cervix, cow ...

  16. Five years of opening the electricity market in Germany: an assessment

    International Nuclear Information System (INIS)

    Feder, A.

    2004-01-01

    In 1998, the German federal government decided to transpose in national law the principle of competition in the sector of electricity. To set up an electricity market, the new law has more or less dismantled the former system of the juxtaposed monopolies of approximately nine hundred local energy firms. The author tries to answer the following questions: How were the new market's legal and institutional modalities determined? What political choices underlie them? What benefits will consumers draw from this liberalization? What assessment has Germany made about these past five years ? What are the hopes and fears for coming years? (author)

  17. 'Putting Life in Years' (PLINY) telephone friendship groups research study: pilot randomised controlled trial.

    Science.gov (United States)

    Mountain, Gail A; Hind, Daniel; Gossage-Worrall, Rebecca; Walters, Stephen J; Duncan, Rosie; Newbould, Louise; Rex, Saleema; Jones, Carys; Bowling, Ann; Cattan, Mima; Cairns, Angela; Cooper, Cindy; Edwards, Rhiannon Tudor; Goyder, Elizabeth C

    2014-04-24

    Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). Recruitment and retention of participants to a definitive trial with a recruitment window of 1 year is feasible. For

  18. Use of Prohibited Medication, a Potentially Overlooked Confounder in Clinical Trials: Omarigliptin (Once-weekly DPP-4 Inhibitor) Monotherapy Trial in 18- to 45-year-olds.

    Science.gov (United States)

    Gantz, Ira; Sokolova, Liubov; Jain, Lokesh; Iredale, Carol; O'Neill, Edward A; Wei, Ziwen; Lam, Raymond; Suryawanshi, Shailaja; Kaufman, Keith D; Engel, Samuel S; Lai, Eseng

    2017-10-01

    The objective of this clinical trial was to assess the efficacy and safety of omarigliptin monotherapy in young adult patients with type 2 diabetes mellitus (T2DM). Unexpected efficacy results in this trial led to a series of investigations that identified the use of prohibited medication by a substantial number of trial patients. Patients with T2DM who were ≥18 to hemoglobin (HbA 1c ), 2-hour postmeal glucose, and fasting plasma glucose, and to assess the safety and tolerability of omarigliptin. Additional investigations into trial conduct included the measurement of drug levels for omarigliptin and metformin in blood samples collected for future biomedical research, available for approximately one half of the patients. The mean age of trial participants was 39.2 years, approximately 60% were male, mean body mass index was 32.5 kg/m2, and mean duration of diabetes was 3.1 years. The mean baseline HbA 1c value was 7.9% in the omarigliptin group and 8.1% in the placebo group. After 24 weeks, the least squares mean change (95% CI) in HbA 1c value from baseline was -0.33% (-0.60 to -0.06) in the omarigliptin group and -0.45% (-0.72 to -0.18) in the placebo group, with a between-group difference of 0.12% (-0.26 to 0.49; P = 0.535). Similarly, no between-group difference was observed for the other glycemic parameters (2-hour postmeal glucose and fasting plasma glucose levels). No issues were identified in drug allocation, dispensing or supply, patient compliance with trial medication, sample handling or analysis, or site trial conduct that explained the observed results. Measurement of drug levels from future biomedical research samples uncovered the use, with no investigator knowledge, of an antihyperglycemic agent that was prohibited by the protocol (ie, metformin) by 42.4% (39 of 92) of patients. Metformin was used by more patients in the placebo group (57% [25 of 44]) than in the omarigliptin group (29% [14 of 48]). The use of prohibited metformin in a trial of a

  19. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials.

    Science.gov (United States)

    Reddy, Vivek Y; Doshi, Shephal K; Kar, Saibal; Gibson, Douglas N; Price, Matthew J; Huber, Kenneth; Horton, Rodney P; Buchbinder, Maurice; Neuzil, Petr; Gordon, Nicole T; Holmes, David R

    2017-12-19

    The PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) with the Watchman device (Boston Scientific, St. Paul, Minnesota) was equivalent to warfarin for preventing stroke in atrial fibrillation, but had a high rate of complications. In a second randomized trial, PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), the complication rate was low. The warfarin cohort experienced an unexpectedly low ischemic stroke rate, rendering the efficacy endpoints inconclusive. However, these outcomes were based on relatively few patients followed for a relatively short time. The final results of the PREVAIL trial, both alone and as part of a patient-level meta-analysis with the PROTECT AF trial, are reported with patients in both trials followed for 5 years. PREVAIL and PROTECT AF are prospective randomized clinical trials with patients randomized 2:1 to LAAC or warfarin; together, they enrolled 1,114 patients for 4,343 patient-years. Analyses are by intention-to-treat, and rates are events per 100 patient-years. For the PREVAIL trial, the first composite coprimary endpoint of stroke, systemic embolism (SE), or cardiovascular/unexplained death did not achieve noninferiority (posterior probability for noninferiority = 88.4%), whereas the second coprimary endpoint of post-procedure ischemic stroke/SE did achieve noninferiority (posterior probability for noninferiority = 97.5%); the warfarin arm maintained an unusually low ischemic stroke rate (0.73%). In the meta-analysis, the composite endpoint was similar between groups (hazard ratio [HR]: 0.820; p = 0.27), as were all-stroke/SE (HR: 0.961; p = 0.87). The ischemic stroke/SE rate was numerically higher with LAAC, but this difference did not reach statistical significance (HR: 1.71; p = 0.080). However, differences in

  20. Bavarian pilot plants for te production of biogas. Results from five years of monitoring; Bayerische Pilotbetriebe zur Biogasproduktion. Ergebnisse aus fuenf Jahren Monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Effenberger, Mathias; Ebertseder, Florian; Kissel, Rainer [Bayerische Landesanstalt fuer Landwirtschaft, Freising (Germany). Inst. fuer Landtechnik und Tierhaltung; Djatkov, Djordje [Novi Sad Univ. (Serbia). Lehrstuhl fuer Biosystemtechnik

    2012-11-15

    For more than five years, the Institute for Agricultural Engineering and Animal Husbandry (Freising, Federal Republic of Germany) performs a monitoring of agricultural biogas plants in Bavaria (Federal Republic of Germany). The results and experiences from the observations of already 21 so-called Bavarian pilot plants are a source of information for consultants, practitioners and scientists. The analysis of the development of individual plants over several years is particularly informative. In many cases, the power plants of the first campaign have an insufficient thermal utilization. Throughout the years, the concept of the thermal utilization was improved continuously improved. In connection with this, the performance of the biogas plants was improved often. Thereby it could be shown that such a repowering is a meaningful risk for the stability and efficiency of the fermentation process. Thus, the repowering should be planned carefully. The long-term monitoring of biogas plants delivers not only insights into the state f the art of agricultural biogas plants, but also especially the scientific fundament for the development of consulting support for a targeted increase of the plant efficiency. A method was developed in order to evaluate the efficiency of biogas plants due to the documented state of the art and expert knowledge. However, the key performance indicators of the plant have to be set carefully so that the consulting support is loadable. Under this aspect, this branch of industry should be sensitized within the background of an increasing and in partial authorized criticisms of the efficiency and environmental impact of biogas plants.

  1. Still the One: Reflections on Sixty-Five Years of Resilience and Relevance

    Science.gov (United States)

    Adcock, Donald; Ballard, Susan

    2015-01-01

    2016 marks an important milestone for the American Association of School Librarians (AASL). Despite the ever-changing and always-challenging economic, political, and societal landscape, for nearly sixty-five years the association has grown and prospered within the structure of the American Library Association (ALA) and remains "the only…

  2. Key projects to be enforced during the 11th Five-year Plan

    Institute of Scientific and Technical Information of China (English)

    2009-01-01

    @@ Addressing major S&T issues of strategic importance to China's socioeconomic growth, national security and development sustainability, the key projects of CAS during the period of the 11th Five-year Plan (2006-2010) are large-scale research initiatives with an expectation to give rise to S&T breakthroughs.

  3. Five years of LRO laser altimetry at the Moon

    Science.gov (United States)

    Smith, David E.; Zuber, Maria T.

    After five years of near-continuous operation at the Moon, the Lunar Orbiter Laser Altimeter (LOLA) on LRO continues to collect altimetry, surface roughness, slope and normal reflectance data. LOLA has acquired over 6 billion altimeter measurements, all geodetically controlled to the center-of-mass of the Moon with a radial precision of around 10 cm and an accuracy of about 1 meter. The position of the measurements on the lunar surface is primarily limited by the knowledge of the position of the spacecraft in orbit and in the last few years the LRO orbit accuracy has improved significantly as a result of the accurate gravity model of the Moon developed by the GRAIL Discovery mission. Our present estimate of positional accuracy is less than 10 m rms but is only achievable with a GRAIL gravity model to at least degree and order 600 because of the perturbing gravitational effect of the Moon’s surface features. Significant improvements in the global shape and topography have assisted the Lunar Reconnaissance Orbiter Camera (LROC) stereo mapping program, and the identification of potential lunar landing sites for ESA and Russia, particularly in the high-latitude polar regions where 5- and 10-meter average horizontal resolution has been obtained. LOLA’s detailed mapping of these regions has improved the delineation of permanently-shadowed areas and assisted in the understanding of the LEND neutron data, and its relationship to surface slopes. Recently a global, calibrated LOLA normal albedo dataset at 1064 nm has been developed.

  4. Hotspot detection using space-time scan statistics on children under five years of age in Depok

    Science.gov (United States)

    Verdiana, Miranti; Widyaningsih, Yekti

    2017-03-01

    Some problems that affect the health level in Depok is the high malnutrition rates from year to year and the more spread infectious and non-communicable diseases in some areas. Children under five years old is a vulnerable part of population to get the malnutrition and diseases. Based on this reason, it is important to observe the location and time, where and when, malnutrition in Depok happened in high intensity. To obtain the location and time of the hotspots of malnutrition and diseases that attack children under five years old, space-time scan statistics method can be used. Space-time scan statistic is a hotspot detection method, where the area and time of information and time are taken into account simultaneously in detecting the hotspots. This method detects a hotspot with a cylindrical scanning window: the cylindrical pedestal describes the area, and the height of cylinder describe the time. Cylinders formed is a hotspot candidate that may occur, which require testing of hypotheses, whether a cylinder can be summed up as a hotspot. Hotspot detection in this study carried out by forming a combination of several variables. Some combination of variables provides hotspot detection results that tend to be the same, so as to form groups (clusters). In the case of infant health level in Depok city, Beji health care center region in 2011-2012 is a hotspot. According to the combination of the variables used in the detection of hotspots, Beji health care center is most frequently as a hotspot. Hopefully the local government can take the right policy to improve the health level of children under five in the city of Depok.

  5. Five-year change in morale is associated with negative life events in very old age.

    Science.gov (United States)

    Näsman, Marina; Niklasson, Johan; Saarela, Jan; Nygård, Mikael; Olofsson, Birgitta; Conradsson, Mia; Lövheim, Hugo; Gustafson, Yngve; Nyqvist, Fredrica

    2017-10-27

    The objectives were to study changes in morale in individuals 85 years and older, and to assess the effect of negative life events on morale over a five-year follow-up period. The present study is based on longitudinal data from the Umeå85+/GERDA-study, including individuals 85 years and older at baseline (n = 204). Morale was measured with the Philadelphia Geriatric Center Morale Scale (PGCMS). Negative life events were assessed using an index including 13 negative life events occurring during the follow-up period. Linear regression was used for the multivariate analyses. The majority of the sample (69.1%) had no significant changes in morale during the five-year follow-up. However, the accumulation of negative life events was significantly associated with a greater decrease in PGCMS. A higher baseline PGCMS score did not attenuate the adverse effect negative life events had on morale. Morale seemed to be mainly stable in a five-year follow-up of very old people. It seems, nonetheless, that individuals are affected by negative life events, regardless of level of morale. Preventing negative life events and supporting individuals who experience multiple negative life events could have important implications for the care of very old people.

  6. Restorations in abrasion/erosion cervical lesions: 8-year results of a triple blind randomized controlled trial.

    Science.gov (United States)

    Dall'Orologio, Giovanni Dondi; Lorenzi, Roberta

    2014-10-01

    An equivalence randomized controlled trial within the subject was organized to evaluate the clinical long-term success of a new 2-step etch & rinse adhesive and a new nano-filled ormocer. 50 subjects, 21 males and 29 females aged between 21 and 65, were randomized to receive 150 restorations, 100 with the new restorative material, 50 with the composite as control, placed in non-carious cervical lesions with the same bonding system. The main outcome measure was the cause of failure at 8 years. Randomization was number table-generated, with allocation concealment by opaque sequentially numbered sealed and stapled envelopes. Subjects, examiner, and analyst were blinded to group assignment. Two interim analyses were performed. Data were analyzed by ANOVA and Cox test (P failures in the experimental group and four failures in the control group. The cumulative loss rate was 7% for both restorative materials, with the annual failure lower than 1%, without any statistically significant difference. There were two key elements of failure: the presence of sclerotic dentin and the relationship between lesion and gingival margin.

  7. Forecasting value added of agricultural sub-sectors during fourth five-year development plan in iran

    International Nuclear Information System (INIS)

    Nassabian, S.

    2009-01-01

    This article focuses on forecasting the values added of agricultural sub-sectors, including agronomy, fishing, forestry, animal husbandry and agricultural services, using the Artificial Neural Networks (ANN) model. It compares the resulting figures with the target estimates throughout the plan within the years 1384-1388 (2005-2009). It turns out that the forecasted values added in the sub-sectors of agronomy and agricultural services are higher and slower than the estimated values added required due to the plan, respectively. Also the high conformity of the estimated and forecasted value added on the horizon of the fourth five-year plan, while the other sub-sectors both the values are close to each other. The results indicate that the capability of ANN method for forecasting variables is more suitable than the other methods. (author)

  8. CO2 emissions and economic development: China's 12th five-year plan

    International Nuclear Information System (INIS)

    Meng Ming; Niu Dongxiao; Shang Wei

    2012-01-01

    For the period of the 12th Five-Year Plan (2011–2015), the Chinese government has decided to reconsider and adjust its policies on economic development because of the pressures of CO 2 emissions and fossil energy consumption. The current paper adopts the logarithmic Stochastic Impacts by Regression on Population, Affluence, and Technology (STIRPAT) model to simulate the relationship between CO 2 emissions and other economic development factors in China. Three groups of outliers are found using samples from 1989 to 2008 and the Partial Least Square (PLS) regularity test method. The outlier analysis reveals three important areas for CO 2 reduction: (a) decreasing the share of coal to the total energy consumption and replacing it with non-fossil energies; (b) controlling vehicles used in the cities as well as (c) adjusting industrial structure. Furthermore, based on the social and economic realities of China, the current paper designs six feasible development scenarios for the period covered by the 12th Five-Year Plan and predicts the values of each factor in each scenario. The values can test the implementation of China's CO 2 control development concept. The experiences obtained by outlier analysis can be of significant reference value for realizing the predicted scenarios. - Highlights: ► Using STIRPAT to analyze China's CO 2 emissions and economic development factors. ► Using the PLS outlier test method, three groups of outliers are found. ► Outlier analysis reveals three important areas on reducing CO 2 emissions. ► We design six feasible scenarios for the period covered by the 12th Five-Year Plan. ► We predict the values of each factor in each scenario.

  9. The Scope of Numeracy after Five Years

    Directory of Open Access Journals (Sweden)

    H.L. Vacher

    2013-01-01

    Full Text Available The purpose of this editorial is to provide an efficient way for readers and potential authors to see (a what type of papers are published in this journal and (b what subjects are appropriate. The editorial consists mainly of about a dozen pages of tables including live links to the papers’ access/abstract pages to facilitate easy browsing. In the first table, the 85 papers that have been published in the journal’s first five years are classified into: review papers; research papers; case studies; essays; book reviews; columns; and editorials about the journal. In the second table, the papers are inventoried into overlapping sets on: assessment; QL and writing; the construct of QL; focused QL courses and curricula; QL across the curriculum; QL centers; algebra and calculus education; statistics education; intersections with science and engineering; intersections with social sciences; financial numeracy; health numeracy; math anxiety; and cognition. Browsing these links confirms what we said in the first editorial: the scope of Numeracy is huge.

  10. Accelerated partial breast irradiation with external beam three-dimensional conformal radiotherapy. Five-year results of a prospective phase II clinical study

    Energy Technology Data Exchange (ETDEWEB)

    Mozsa, Emoeke [National Institute of Oncology, Centre of Radiotherapy, Budapest (Hungary); Landesklinikum Wiener Neustadt, Department of Radiooncology and Radiotherapy, Wiener Neustadt (Austria); Meszaros, Norbert; Major, Tibor; Froehlich, Georgina; Stelczer, Gabor; Fodor, Janos; Polgar, Csaba [National Institute of Oncology, Centre of Radiotherapy, Budapest (Hungary); Sulyok, Zoltan [National Institute of Oncology, Centre of Surgery, Budapest (Hungary)

    2014-05-15

    The aim of this study was to report the 5-year results of accelerated partial breast irradiation (APBI) using external beam three-dimensional conformal radiotherapy (3D-CRT). Between 2006 and 2011, 44 patients with low-risk, stage I-II breast cancer underwent breast-conserving surgery. Postoperative APBI was given by means of 3D-CRT using three to five non-coplanar fields. The total dose of APBI was 36.9 Gy (nine fractions of 4.1 Gy b.i.d.). The mean follow-up time was 58.2 months for surviving patients. Survival results, side effects, and cosmetic results were assessed. One (2.3 %) local recurrence was observed, for a 5-year actuarial rate of 3.7 %. Neither regional nor distant failure was observed. Two patients died of internal disease. The 5-year disease-free, cancer-specific, and overall survival rates were 96.3, 100, and 95.1 %, respectively. Acute side effects included grade 1 (G1) erythema in 75 %, G1 parenchymal induration in 46 %, and G1 pain in 46 % of patients. No G2 or higher acute side effect occurred. Late side effects included G1, G2, and G3 fibrosis in 44, 7, and 2 % of patients, respectively, G1 skin pigmentation in 12 %, and G1 pain in 2 %. Asymptomatic fat necrosis occurred in 14 %. Cosmetic results were rated excellent or good in 86 % of cases by the patients themselves and 84 % by the physicians. The 5-year local tumor control, toxicity profile, and cosmetic results of APBI delivered with external beam 3D-CRT are encouraging and comparable to other APBI series. (orig.) [German] Evaluation der 5-Jahres-Ergebnisse bezueglich Ueberleben, Tumorkontrolle, Nebenwirkungen und Kosmetik nach Teilbrustbestrahlung (APBI) mittels 3-D-konformaler, akzelerierter Radiotherapie (3D-CRT). Zwischen 2006 und 2011 wurden 44 Patienten mit Brustkrebs im Stadium I-II und niedrigem Risikoprofil brusterhaltend operiert. Die adjuvante, 3-D-konformale APBI wurde mittels 3-5 nonkoplanarer Feldern durchgefuehrt. Die Gesamtdosis betrug 36,9 Gy bei 9 -mal 4,1 Gy b.i.d.. Nach

  11. Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India.

    Science.gov (United States)

    Gass, Jonathon D; Misra, Anamika; Yadav, Mahendra Nath Singh; Sana, Fatima; Singh, Chetna; Mankar, Anup; Neal, Brandon J; Fisher-Bowman, Jennifer; Maisonneuve, Jenny; Delaney, Megan Marx; Kumar, Krishan; Singh, Vinay Pratap; Sharma, Narender; Gawande, Atul; Semrau, Katherine; Hirschhorn, Lisa R

    2017-09-07

    There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In the trial, over 6300 deliveries were observed and over 153,000 mother-baby pairs across 120 study sites were followed to assess health outcomes. We designed and implemented a robust and integrated DQA system to sustain high-quality data throughout the trial. We designed the Data Quality Monitoring and Improvement System (DQMIS) to reinforce six dimensions of data quality: accuracy, reliability, timeliness, completeness, precision, and integrity. The DQMIS was comprised of five functional components: 1) a monitoring and evaluation team to support the system; 2) a DQA protocol, including data collection audits and targets, rapid data feedback, and supportive supervision; 3) training; 4) standard operating procedures for data collection; and 5) an electronic data collection and reporting system. Routine audits by supervisors included double data entry, simultaneous delivery observations, and review of recorded calls to patients. Data feedback reports identified errors automatically, facilitating supportive supervision through a continuous quality improvement model. The five functional components of the DQMIS successfully reinforced data reliability, timeliness, completeness, precision, and integrity. The DQMIS also resulted in 98.33% accuracy across all data collection activities in the trial. All data collection activities demonstrated improvement in accuracy throughout implementation. Data collectors demonstrated a statistically significant (p = 0.0004) increase in accuracy throughout

  12. A Retrospective Analysis of the Results of a Five-Year (2005-2009) Parasitological Examination for Common Intestinal Parasites from Bale-Robe Health Center, Robe Town, Southeastern Ethiopia.

    Science.gov (United States)

    Chala, Bayissa

    2013-01-01

    A cross-sectional retrospective survey using the past five years clinical records (2005-2009) was conducted. The study was aimed at assessing the status of common intestinal parasites from Bale-Robe Health Center, Southeastern Ethiopia, in 2009/2010. The survey involved collection of data recorded on intestinal parasite from the health center during 2005-2009. Precoded questionnaires and interviews were also supplemented for knowledge attitude practices survey (KAPs survey) to assess awareness level of treatment seekers. Analysis of the various associations and strength of significant variations among qualitative and quantitative variables were assessed. The results revealed that Entamoeba histolytica (36.1%) and Giardia lamblia (11.0%), both being protozoan parasites were found to be the most prevalent intestinal parasites encountered during 2005-2009. The least prevalent intestinal parasite recorded was Strongyloides stercoralis (1.1%). Most intestinal parasites were detected among age group of 15 years and above than 0-4 and 5-14 years as shown in Table 4. There was a significant correlation between intestinal parasites prevalence and the age of treatment seeking individuals (P parasites in the area.

  13. Five-Year Analysis of Treatment Efficacy and Cosmesis by the American Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial in Patients Treated With Accelerated Partial Breast Irradiation

    International Nuclear Information System (INIS)

    Vicini, Frank; Beitsch, Peter; Quiet, Coral; Gittleman, Mark; Zannis, Vic; Fine, Ricky; Whitworth, Pat; Kuerer, Henry; Haffty, Bruce; Keisch, Martin; Lyden, Maureen

    2011-01-01

    Purpose: To present 5-year data on treatment efficacy, cosmetic results, and toxicities for patients enrolled on the American Society of Breast Surgeons MammoSite breast brachytherapy registry trial. Methods and Materials: A total of 1440 patients (1449 cases) with early-stage breast cancer receiving breast-conserving therapy were treated with the MammoSite device to deliver accelerated partial-breast irradiation (APBI) (34 Gy in 3.4-Gy fractions). Of 1449 cases, 1255 (87%) had invasive breast cancer (IBC) (median size, 10 mm) and 194 (13%) had ductal carcinoma in situ (DCIS) (median size, 8 mm). Median follow-up was 54 months. Results: Thirty-seven cases (2.6%) developed an ipsilateral breast tumor recurrence (IBTR), for a 5-year actuarial rate of 3.80% (3.86% for IBC and 3.39% for DCIS). Negative estrogen receptor status (p = 0.0011) was the only clinical, pathologic, or treatment-related variable associated with IBTR for patients with IBC and young age (<50 years; p = 0.0096) and positive margin status (p = 0.0126) in those with DCIS. The percentage of breasts with good/excellent cosmetic results at 60 months (n = 371) was 90.6%. Symptomatic breast seromas were reported in 13.0% of cases, and 2.3% developed fat necrosis. A subset analysis of the first 400 consecutive cases enrolled was performed (352 with IBC, 48 DCIS). With a median follow-up of 60.5 months, the 5-year actuarial rate of IBTR was 3.04%. Conclusion: Treatment efficacy, cosmesis, and toxicity 5 years after treatment with APBI using the MammoSite device are good and similar to those reported with other forms of APBI with similar follow-up.

  14. A Multidisciplinary Approach to a Seven Year-Old Patient with Incontinentia Pigmenti: A Case Report and Five-Year Follow Up

    Directory of Open Access Journals (Sweden)

    Rezvan Rafatjou

    2016-11-01

    Full Text Available Incontinentia pigmenti is a rare inherited disorder involving abnormalities of the skin, hair, eyes, musculoskeletal system, central nervous system, and the teeth. Dental abnormalities are the most common manifestations of this disorder. The purpose of this case report was to present the clinical and radiological findings of a seven-year-old girl as well as the results of her five-year follow up. The patient showed faded linear pigmented macular lesions on the trunk and on upper and lower limbs. Dental examination was notable for conical and peg-shaped anterior teeth as well as delayed eruption of primary and permanent teeth. In addition to conservative treatments, prosthetic treatments such as interim removable partial dentures were indicated for the patient.Keywords: Incontinentia Pigmenti; Dental Prosthesis; Genetic Diseases, Inborn 

  15. High School Students With Reading Comprehension Difficulties: Results of a Randomized Control Trial of a Two-Year Reading Intervention.

    Science.gov (United States)

    Vaughn, Sharon; Roberts, Greg; Wexler, Jade; Vaughn, Michael G; Fall, Anna-Mária; Schnakenberg, Jennifer B

    2015-01-01

    A 2-year, randomized control trial with 9th to 10th grade students with significant reading problems was provided for 50 minutes a day in small groups. Comparison students were provided an elective class and treatment students the reading intervention. Students were identified as demonstrating reading difficulties through failure on their state accountability test and were randomly assigned to one of three treatment conditions and a business as usual (BAU) condition: reading without dropout prevention, reading with dropout prevention, dropout prevention without reading, or a BAU condition. Findings from the 2-year reading intervention (reading with and without dropout prevention combined and BAU) are reported in this article. Students in reading treatment compared to students in BAU demonstrated significant gains on reading comprehension (effect size = .43), and improved reading was associated with better grades in social studies. Findings from this study provide a rationale for further implementation and investigation of intensive intervention for high school students with reading difficulties. © Hammill Institute on Disabilities 2014.

  16. The TrialsTracker: Automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions.

    Science.gov (United States)

    Powell-Smith, Anna; Goldacre, Ben

    2016-01-01

    Background : Failure to publish trial results is a prevalent ethical breach with a negative impact on patient care. Audit is an important tool for quality improvement. We set out to produce an online resource that automatically identifies the sponsors with the best and worst record for failing to share trial results. Methods: A tool was produced that identifies all completed trials from clinicaltrials.gov, searches for results in the clinicaltrials.gov registry and on PubMed, and presents summary statistics for each sponsor online. Results : The TrialsTracker tool is now available. Results are consistent with previous publication bias cohort studies using manual searches. The prevalence of missing studies is presented for various classes of sponsor. All code and data is shared. Discussion: We have designed, built, and launched an easily accessible online service, the TrialsTracker, that identifies sponsors who have failed in their duty to make results of clinical trials available, and which can be maintained at low cost. Sponsors who wish to improve their performance metrics in this tool can do so by publishing the results of their trials.

  17. A Phase 3 Trial of 2 Years of Androgen Suppression and Radiation Therapy With or Without Adjuvant Chemotherapy for High-Risk Prostate Cancer: Final Results of Radiation Therapy Oncology Group Phase 3 Randomized Trial NRG Oncology RTOG 9902

    Energy Technology Data Exchange (ETDEWEB)

    Rosenthal, Seth A., E-mail: rosents@sutterhealth.org [Radiation Oncology, Sutter Cancer Centers, Roseville, California (United States); Hunt, Daniel [NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States); Sartor, A. Oliver [Tulane University Medical Center, New Orleans, Louisiana (United States); Pienta, Kenneth J. [Johns Hopkins School of Medicine, Baltimore, Maryland (United States); Gomella, Leonard [Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States); Grignon, David [Indiana University, Bloomington, Indiana (United States); Rajan, Raghu [McGill University, Montreal, Quebec (Canada); Kerlin, Kevin J. [Community Clinical Oncology Program, Southeast Cancer Control Consortium, Inc, Winston-Salem, North Carolina (United States); Jones, Christopher U. [Radiation Oncology, Sutter Cancer Centers, Roseville, California (United States); Radiological Associates of Sacramento, Sacramento, California (United States); Dobelbower, Michael [University of Alabama at Birmingham Medical Center, Birmingham, Alabama (United States); Shipley, William U. [Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (United States); Zeitzer, Kenneth [Albert Einstein Medical Center, Bronx, New York (United States); Hamstra, Daniel A. [University of Michigan Medical Center, Ann Arbor, Michigan (United States); Donavanik, Viroon [Christiana Care Health Services, Inc, Wilmington, Delaware (United States); Rotman, Marvin [State University of New York Health Science Center–Brooklyn, Brooklyn, New York (United States); Hartford, Alan C. [Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (United States); Michalski, Jeffrey [Washington University, St. Louis, Missouri (United States); Seider, Michael [Akron City Hospital, Akron, Ohio (United States); Kim, Harold [Wayne State University, Detroit, Michigan (United States); and others

    2015-10-01

    Purpose: Long-term (LT) androgen suppression (AS) with radiation therapy (RT) is a standard treatment of high-risk, localized prostate cancer (PCa). Radiation Therapy Oncology Group 9902 was a randomized trial testing the hypothesis that adjuvant combination chemotherapy (CT) with paclitaxel, estramustine, and oral etoposide plus LT AS plus RT would improve overall survival (OS). Methods and Materials: Patients with high-risk PCa (prostate-specific antigen 20-100 ng/mL and Gleason score [GS] ≥7 or clinical stage ≥T2 and GS ≥8) were randomized to RT and AS (AS + RT) alone or with adjuvant CT (AS + RT + CT). CT was given as four 21-day cycles, delivered beginning 28 days after 70.2 Gy of RT. AS was given as luteinizing hormone-releasing hormone for 24 months, beginning 2 months before RT plus an oral antiandrogen for 4 months before and during RT. The study was designed based on a 6% improvement in OS from 79% to 85% at 5 years, with 90% power and a 2-sided alpha of 0.05. Results: A total of 397 patients (380 eligible) were randomized. The patients had high-risk PCa, 68% with GS 8 to 10 and 34% T3 to T4 tumors, and median prostate-specific antigen of 22.6 ng/mL. The median follow-up period was 9.2 years. The trial closed early because of excess thromboembolic toxicity in the CT arm. The 10-year results for all randomized patients revealed no significant difference between the AS + RT and AS + RT + CT arms in OS (65% vs 63%; P=.81), biochemical failure (58% vs 54%; P=.82), local progression (11% vs 7%; P=.09), distant metastases (16% vs 14%; P=.42), or disease-free survival (22% vs 26%; P=.61). Conclusions: NRG Oncology RTOG 9902 showed no significant differences in OS, biochemical failure, local progression, distant metastases, or disease-free survival with the addition of adjuvant CT to LT AS + RT. The trial results provide valuable data regarding the natural history of high-risk PCa treated with LT AS + RT and have implications for

  18. Two-year results of vital pulp therapy in permanent molars with irreversible pulpitis: an ongoing multicenter randomized clinical trial.

    Science.gov (United States)

    Asgary, Saeed; Eghbal, Mohammad Jafar; Ghoddusi, Jamileh

    2014-01-01

    Oral healthcare expenses are increasing rapidly as a result of the growth of high-cost health technologies worldwide. In many developing/developed countries, low-cost tooth extraction is the alternative treatment option for a high-cost root canal therapy (RCT) for management of human molars with irreversible pulpitis. Vital pulp therapy with calcium-enriched mixture cement (VPT/CEM) as a new alternative treatment option has demonstrated excellent treatment outcomes up to 1 year; if 2-year radiographic/clinical effectiveness as well as cost-effectiveness of the VPT/CEM is also non-inferior compared with RCT, it can serve as a viable treatment for mature molars with irreversible pulpitis. In this prospective, multicenter (n = 23), non-inferiority clinical trial, 407 patients were randomized to either one-visit RCT (n = 202) or VPT/CEM (n = 205) for 27 months. In this part of study, the primary outcome measure was the 2-year clinical and radiographic treatment outcomes. Cost-effectiveness was also analyzed. Mean follow-up times were 24.62 ± 0.72 and 24.61 ± 0.69 months in RCT (n = 166) and VPT/CEM (n = 166) arms, respectively. Clinical success rates in the two study arms were equal (98.19%); however, radiographic success rates were 79.5 and 86.7% in RCT and VPT/CEM arms, respectively, with no statistical difference (P = 0.053). The treatment time span mean was approximately three times greater in the RCT than in the VPT/CEM arm (94.07 vs. 31.09 min; P pulpitis. Vital pulp therapy with CEM is a cost-effective and reliable biological technique for endodontic treatment of permanent molar teeth with irreversible pulpitis and can be recommended for general clinical practice.

  19. A five year study of the attitudes, perceptions, and philosophies of five secondary science education teachers prepared in the constructivist teaching methodology advanced at the University of Iowa

    Science.gov (United States)

    Hollenbeck, James Edward

    1999-11-01

    The present study researched the attitudes, Perceptions, and philosophies of five secondary education science teachers prepared in the constructivist teaching methodology advanced at the University of Iowa. This study is a continuation of a three-year study---the Salish I Project supported by the US Department of Education. The teachers studied are five 1993 University of Iowa Science Education Center graduates who have taught for five years. The main objective of the present study was finding answers to four questions aiming at further understanding of the impact and importance of the preservice education in I the constructivist teaching methodology of new teachers, and the changes they experience in the first five years of teaching. The instruments used in the study are various as they cover a wide range of different categories of beliefs I in terms of teaching, learning, teacher performance and view of school. The following trends came out on reviewing all of the data: in the first year of teaching three of the five teachers studied taught as constructivist teachers. in the third year of teaching, the classroom practices of the teachers converged more closely to their beliefs and preservice preparation. In the fifth year, all five teachers were ranked as constructivist in their teaching methodology in the classroom. Using the Wilcoxson test, significant, positive relationships were revealed between the teacher's philosophy of teaching and learning, with their actual practice. Teacher's philosophy and teaching practice were compared with selected standards set forth by the National Science Education Standards and were found to be in close alignment in their fifth year of teaching. Teachers prepared in the constructivist methodology are concerned about their subject content and value student input and reflection. The teachers reported using student-initiated ideas, alternative assessment strategies and being receptive to alternatives. Other important factors

  20. Assessment of China's renewable energy contribution during the 12th Five Year Plan

    International Nuclear Information System (INIS)

    Hong, Lixuan; Zhou, Nan; Fridley, David; Raczkowski, Chris

    2013-01-01

    In recent years, China has been ambitious in investing and developing renewable energy technologies, aiming to enhance its energy security, mitigate its energy-related CO 2 emissions and develop renewable energy industry. The 12th Five Year Plan (2011–2015) has set clear targets on installed capacities of different renewable energy technologies. This study aimed to assess the possible contribution of 12th Five Year Plan for China's future energy system and identify factors that might influence its impacts. First, current status of renewable energy development in China has been reviewed. Then several energy scenarios have been developed in an hourly simulation using an energy system analysis tool EnergyPLAN. It was identified that existing grid bottleneck would greatly reduce the potential contribution of renewable installations in terms of share of renewable electricity generation, share of non-fossil fuels in primary energy and system CO 2 emissions. In contrast, improving technical performance of renewable energy technologies and sectoral energy efficiency plays an important role in increasing the share of renewables and promoting China’s energy system transition. Finally, some policy suggestions were drawn to facilitate a better implementation of the renewable energy plan. - Highlights: • China's renewable energy contribution during the 12th Five Year Plan was assessed. • Non-fossil fuel targets in primary energy for 2015 and 2020 could be easily achieved. • Grid bottlenecks severely decrease the share of RES-E in electricity generation through the 12th Five Year Period. • Improved technical performance of renewable technologies and sectoral energy efficiency are extremely important for achieving higher RES-E share. • Several policy suggestions were drawn

  1. Analysis of the PISC II trials results

    International Nuclear Information System (INIS)

    Haines, N.

    1988-01-01

    The paper presents the analysis scheme of the Programme for the Inspection of Steel Components PISC II trial results. The objective of the PISC II exercise is to evaluate the effectiveness of current and advanced NDT techniques for inspection of reactor pressure vessel components. The analysis scheme takes data from the Round Robin Trial (RRT) and Destructive Examination, then reduces it to a manageable form in order to present useful conclusions on the effectiveness of NDT. A description is given of the data provided by RRT, the data analysis scheme, the definition of analysis parameters, and the main methods of data presentation. (U.K.)

  2. Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial.

    Science.gov (United States)

    Rushing, J; Wing, R; Wadden, T A; Knowler, W C; Lawlor, M; Evans, M; Killean, T; Montez, M; Espeland, M A; Zhang, P

    2017-03-01

    The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10 years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention. The ILI was designed to promote weight loss and increase physical activity. It involved a combination of group plus individual intervention sessions, with decreasing frequency of contact over the 10 years. The intervention incorporated a variety of strategies, including meal replacement products, to improve weight loss outcomes. The costs of intervention delivery were derived from staff surveys of effort and from records of intervention materials from the 16 US academic clinical trial sites. Costs were calculated from the payer perspective and presented in 2012 dollars. During the first year, when intervention delivery was most intensive, the annual cost of intervention delivery, averaged (standard deviation) across clinical sites, was $2,864.6 ($513.3) per ILI participant compared with $202.4 ($76.6) per DSE participant. As intervention intensity declined, costs decreased, such that from years 5 to 9 of the trial, the annual cost of intervention was $1,119.8 ($227.7) per ILI participant and $102.9 ($33.0) per DSE participant. Staffing accounted for the majority of costs throughout the trial, with meal replacements and materials to promote adherence accounting for smaller shares. The sustained weight losses produced by the Look AHEAD intervention were supported by intervention costs that were within the range of other weight loss programmes. Future work will include an evaluation of the cost-effectiveness of the ILI and will contain additional follow-up data.

  3. Immediate versus early non-occlusal loading of dental implants placed flapless in partially edentulous patients. One-year results from a randomised controlled trial.

    Science.gov (United States)

    Merli, Mauro; Merli, Aldo; Bernardelli, Francesco; Lombardini, Francesco; Esposito, Marco

    2008-01-01

    To compare immediate versus early (6 weeks) non-occlusal loading of dental implants placed flapless in partially edentulous patients 1 year after loading. Sixty patients were randomised: 30 to the immediately loaded group and 30 to the early loaded group. In order to be immediately loaded, implants were inserted with a minimum torque of > or = 40Ncm. Implants were fully occlusally loaded after 6 months. Outcome measures were prosthesis and implant failures, and biological and biomechanical complications. Five implants in five patients randomised to the immediately loaded group did not reach the required primary implant stability. Three of these implants (two prostheses) were not immediately loaded. Two patients who were randomised to the early loaded group were immediately loaded erroneously. Implants in five patients of the early loaded group were conventionally loaded. No patient dropped out and there were no failures. Two complications occurred in the early and one in the immediately loaded group (no statistically significant difference), but were solved. The use of a flapless technique for placing dental implants in conjunction with non-occlusal immediate or early loading in selected patients can provide excellent clinical results. No differences were observed when comparing implants that were loaded immediately or early. Therefore, when a high primary implant stability is obtained, it might be preferable to load the implants immediately rather than waiting for a few weeks.

  4. Im. A. F. Zasyad'ko coal mine during the eleventh five year plan

    Energy Technology Data Exchange (ETDEWEB)

    Zvyagil' skii, E.L.

    1985-08-01

    The achievements of this mine are chronicled, which began production in December 1958, throughout the eleventh five year plan, showing how the annual targets for coal output, roadway drivage, savings in energy and materials, output per manshift and cost price of coal were met and improved upon in each of the five years. The factors which made possible these achievements in productivity and efficiency are described and include: use of modern equipment and systems, increased mechanization, on-site education and training, improved discipline, reduced absenteeism, incentive schemes and, above all, the full involvement of the coal mine in the program of socialist competition. The social infrastructure supporting the coal mine and its workforce is also described.

  5. Adjuvant external beam radiotherapy in the treatment of endometrial cancer (MRC ASTEC and NCIC CTG EN.5 randomised trials): pooled trial results, systematic review, and meta-analysis.

    Science.gov (United States)

    Blake, P; Swart, Ann Marie; Orton, J; Kitchener, H; Whelan, T; Lukka, H; Eisenhauer, E; Bacon, M; Tu, D; Parmar, M K B; Amos, C; Murray, C; Qian, W

    2009-01-10

    Early endometrial cancer with low-risk pathological features can be successfully treated by surgery alone. External beam radiotherapy added to surgery has been investigated in several small trials, which have mainly included women at intermediate risk of recurrence. In these trials, postoperative radiotherapy has been shown to reduce the risk of isolated local recurrence but there is no evidence that it improves recurrence-free or overall survival. We report the findings from the ASTEC and EN.5 trials, which investigated adjuvant external beam radiotherapy in women with early-stage disease and pathological features suggestive of intermediate or high risk of recurrence and death from endometrial cancer. Between July, 1996, and March, 2005, 905 (789 ASTEC, 116 EN.5) women with intermediate-risk or high-risk early-stage disease from 112 centres in seven countries (UK, Canada, Poland, Norway, New Zealand, Australia, USA) were randomly assigned after surgery to observation (453) or to external beam radiotherapy (452). A target dose of 40-46 Gy in 20-25 daily fractions to the pelvis, treating five times a week, was specified. Primary outcome measure was overall survival, and all analyses were by intention to treat. These trials were registered ISRCTN 16571884 (ASTEC) and NCT 00002807 (EN.5). After a median follow-up of 58 months, 135 women (68 observation, 67 external beam radiotherapy) had died. There was no evidence that overall survival with external beam radiotherapy was better than observation, hazard ratio 1.05 (95% CI 0.75-1.48; p=0.77). 5-year overall survival was 84% in both groups. Combining data from ASTEC and EN.5 in a meta-analysis of trials confirmed that there was no benefit in terms of overall survival (hazard ratio 1.04; 95% CI 0.84-1.29) and can reliably exclude an absolute benefit of external beam radiotherapy at 5 years of more than 3%. With brachytherapy used in 53% of women in ASTEC/EN.5, the local recurrence rate in the observation group at 5 years

  6. Virtual Knowledge Center Five Year Vision

    International Nuclear Information System (INIS)

    KENNY, N.E.

    2003-01-01

    The vision for Virtual Knowledge Center (VKC) is to make information accessible from one verifiable source, provide an environment for knowledge capture and sharing, and provide for automated business process management. VKC will be the foundation for management and integration of information activities at the Hanford Site for the next 5 years. It provides a distinctive solution that can increase return on investment, increase a facility's efficiency, and reduce a project's cost and schedule. This Five-Year Vision presents a clear path forward to support the U.S. Department of Energy and its contractors in their goals of achieving the Site's missions of preparing for the future, restoring the river corridor, and transitioning the central plateau. Diminishing funds and reduced availability of resources has created a direct obligation for the Hanford Site to be more innovative and resourceful in the use of its current information assets. The difficulty and, in some instances, the inability of current systems to effectively and efficiently meet evolving standards and directions, coupled with Hanford's geographical size, pose challenges to information acquisition, sharing, and use. An imbalance exists in the lifecycle process of information between locating information and executing work. The need to capture and retain workers' knowledge for future use was evaluated to identify cost effective alternatives. The VKC is comprised of a suite of technologies that enables seamless access to the information available through integration of databases and systems. The VKC uses web technology to provide the environment for gathering information from disparate data sources. The VKC makes information available to users; allowing them to search, access documents, retain enterprise knowledge, or interact with other users. The VKC provides a single path to electronic information; allows capture of knowledge at its source and makes data and information available for informed decision

  7. Hypofractionated stereotactic photon radiotherapy of posteriorly located choroidal melanoma with five fractions at ten Gy – Clinical results after six years of experience

    International Nuclear Information System (INIS)

    Dunavoelgyi, Roman; Zehetmayer, Martin; Gleiss, Andreas; Geitzenauer, Wolfgang; Kircher, Karl; Georg, Dietmar; Schmidt-Erfurth, Ursula; Poetter, Richard; Dieckmann, Karin

    2013-01-01

    Purpose: To evaluate long-term safety and efficacy of hypofractionated stereotactic photon radiotherapy with 5 five fractions at 10 Gy each in patients with centrally located choroidal melanoma. Materials and Methods: Ninety-one patients with centrally located choroidal melanoma were treated stereotactically at a linear accelerator with 6 MV photon beams with 5 fractions at 10 Gy each. Examinations were performed at baseline and every 3 months in the first 2 years, then every 6 months until 5 years and yearly thereafter. Median follow-up was 37.8 months (IQR 19.2–49.9). They included visual acuity assessment, routine ophthalmological examinations with fundoscopy, echography for measurement of tumor dimensions, medical examinations and, if necessary, fluorescein angiography. Results: Initial tumor base diameters, height and volume were 11.20 mm (IQR 9.10–13.70), 9.80 mm (IQR 7.80–11.70), 4.53 mm (IQR 3.33–6.43) and 253.8 mm 3 (IQR 127.5–477.0). Local tumor control and eye retention rates were 97.7% and 86.4% after 5 years, respectively. Eight patients developed metastatic disease and 3 of them died due to metastatic disease during the follow-up period. Median visual acuity decreased from 0.67 initially to 0.05 at the last individual follow-up (p < 0.001). The most common toxicities (any grade) were radiation retinopathy (n = 39), optic neuropathy (n = 32), radiogenic cataract (n = 21), neovascular glaucoma (n = 15) and dry eye syndrome (n = 10). The 5 year probabilities to remain free of these side effects (any grade) were 26.0%, 45.4%, 55.4%, 72.6% and 80.5%, respectively. The most important prognostic factors for toxicities were the largest tumor base diameter, tumor height and tumor distance to the optic disk. Conclusion: Hypofractionated stereotactic photon radiotherapy with a total dose of 50 Gy delivered in 5 fractions is a highly effective treatment option in patients with centrally located choroidal melanoma and has a moderate toxicity profile

  8. Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures: Vital D study

    Directory of Open Access Journals (Sweden)

    Taylor Roderick

    2009-11-01

    Full Text Available Abstract Background Randomised, placebo-controlled trials are needed to provide evidence demonstrating safe, effective interventions that reduce falls and fractures in the elderly. The quality of a clinical trial is dependent on successful recruitment of the target participant group. This paper documents the successes and failures of recruiting over 2,000 women aged at least 70 years and at higher risk of falls or fractures onto a placebo-controlled trial of six years duration. The characteristics of study participants at baseline are also described for this study. Methods The Vital D Study recruited older women identified at high risk of fracture through the use of an eligibility algorithm, adapted from identified risk factors for hip fracture. Participants were randomised to orally receive either 500,000 IU vitamin D3 (cholecalciferol or placebo every autumn for five consecutive years. A variety of recruitment strategies were employed to attract potential participants. Results Of the 2,317 participants randomised onto the study, 74% (n = 1716/2317 were consented onto the study in the last five months of recruiting. This was largely due to the success of a targeted mail-out. Prior to this only 541 women were consented in the 18 months of recruiting. A total of 70% of all participants were recruited as a result of targeted mail-out. The response rate from the letters increased from 2 to 7% following revision of the material by a public relations company. Participant demographic or risk factor profile did not differ between those recruited by targeted mail-outs compared with other methods. Conclusion The most successful recruitment strategy was the targeted mail-out and the response rate was no higher in the local region where the study had extensive exposure through other recruiting strategies. The strategies that were labour-intensive and did not result in successful recruitment include the activities directed towards the GP medical centres

  9. Irrigation requirements for seed production of five Lomatium species in a semiarid environment

    Science.gov (United States)

    Clinton C. Shock; Erik B. G. Feibert; Alicia Rivera; Lamont D. Saunders; Nancy Shaw; Francis F. Kilkenny

    2016-01-01

    Seeds of native plants are needed for rangeland restoration in the Intermountain West. Many of these plants are rarely cultivated and relatively little is known about the cultural practices required for their seed production. Irrigation trials were conducted for five perennial Lomatium species over multiple years. Lomatium species grown at the Oregon State University...

  10. Nutritional status and associated factors among children less than five years of age in tehsil Zarghoon town, District Quetta, Baluchistan

    International Nuclear Information System (INIS)

    Achakzai, P.; Khan, R.

    2016-01-01

    Background: Globally, more than one-third of mortalities in children under five years of age are attributable to malnutrition. The prevalence of malnourished children in Pakistan is inclining. A knowledge gap exists due to availability of limited literature about the nutritional status of children in rural Baluchistan. Therefore, this study assessed the magnitude and factors associated with nutritional status of children of less than five years of age in Tehsil Zarghoon Town of District Quetta. Methods: A community based cross-sectional study was conducted in two rural union councils of Tehsil Zarghoon Town of District Quetta, selected randomly. An existing questionnaire was modified and three research assistants were hired to collect data from 104 children, selected systematically. Data analysis was done using SPSS-20 and World Health Organization (WHO) Anthro software. Results: Results showed that the proportion of stunting and wasting in children comprising the study population was 48.1% and 9.7% respectively. A significant association was demonstrated between stunting and wasting and socio-demographic characteristics, child health characteristics and maternal health characteristics. Conclusion: It was concluded that the nutritional status of children under five years of age in Tehsil Zarghoon Town of district Quetta was unsatisfactory. Thus, community mobilization and incorporation of nutrition related activities in primary health care are recommended. (author)

  11. Randomized controlled trial comparing TVT-O and TVT-S for the treatment of stress urinary incontinence: 2-year results.

    Science.gov (United States)

    Bianchi-Ferraro, Ana Maria H M; Jarmy-DiBella, Zsuzsanna I K; de Aquino Castro, Rodrigo; Bortolini, Maria Augusta T; Sartori, Marair G F; Girão, Manoel J B C

    2014-10-01

    The aim was to compare the efficacy and safety of single-incision sling TVT-Secur (TVT-S) and transobturator midurethral sling (TVT-O) for the treatment of stress urinary incontinence (SUI) over 2 years' follow-up. This is a randomized controlled trial in which women with SUI were randomly assigned to have either TVT-O (n = 56) or TVT-S (n = 66). Exclusion criteria included: voiding dysfunction, detrusor overactivity, and pelvic organ prolapse beyond the hymen. The primary outcomes were objective and subjective cure rates at a follow-up visit at 24 months, defined as a negative stress test and pad test as well as absence of self-reported SUI symptoms. Secondary endpoints included quality of life assessment using the King's Health Questionnaire (KHQ), and complication and reoperation rates. Analysis was performed using intention to treat, and statistical significance was fixed at 5% (p TVT-S and TVT-O groups were 77.3% and 83.6%, while subjective cure rates were 75.7% and 80.3% respectively, with no statistically significant differences between the techniques. There was a significant improvement in all KHQ domains in both groups (p TVT-O, while the long-term one was tape exposure observed in 5.3% of TVT-O and in 7.5% of TVT-S cases. The efficacy of the TVT-S was similar to that of the TVT-O after 2 years' assessment. This cohort will continue to be followed in order to maintain commitment to contributing data on long-term results.

  12. New developments in Indian space policies and programmes—The next five years

    Science.gov (United States)

    Sridhara Murthi, K. R.; Bhaskaranarayana, A.; Madhusudana, H. N.

    2010-02-01

    Over past four decades Indian space programme has systematically acquired capabilities in space technologies and implemented its programmes with a high level of focus on societal applications. It is developed into a multi-dimensional programme where its strategy is directed towards diverse stake holders and actors such as government, users and beneficiaries including general public, industrial suppliers as well as customers, academia and other space agencies/international organisations. Over the next five years, the Indian space programme has charted an ambitious set of policies and programmes that aim to enhance impacts on society. The major task is to enlarge and diversify the services delivered to a large section of population affected by income, connectivity and digital divides. While efficacy of application of space based systems have been proven in several fields such as tele-education, water resources management, improving productivity of land and out reaching quality health services and others, the crux of the problem is to evolve sustainable and scalable delivery mechanisms on a very large scale and extending over large geographical areas. Essentially the problem shifts from being predominately a technology problem to one of a composite of economic, cultural and social problems. Tackling such problems would need renewal of policies relating to commercial as well as public service systems. Major programmatic initiatives are planned in the next five years involving new and upgraded technologies to expand services from space to fill the gaps and to improve economic efficiency. Thrust is also given to science and exploration mission beyond Chandrayaan-1 and some initial steps for the participation in human space flight. This paper discusses the policy and strategy perspectives of the programmes planned by Indian Space Research Organisation over next five years.

  13. A five year study on the susceptibility of isolates from various parts of ...

    African Journals Online (AJOL)

    tests. The various isolates for the five-year period were Staphylococcus aureus 1000, Klebsiella pneumoniae 340, Proteus mirabilis 38 Escherichia coli 295, Pseudomonas aeroginosa 240, Alcaligenes faecalis 200, Enterobacter aerogenes 175, Acinetobacter baumannii 150, Proteus vulgaris 110, Providencia stuartii 101, ...

  14. Southern Stalemate: Five Years without Public Education in Prince Edward County, Virginia

    Science.gov (United States)

    Bonastia, Christopher

    2012-01-01

    In 1959, Virginia's Prince Edward County closed its public schools rather than obey a court order to desegregate. For five years, black children were left to fend for themselves while the courts decided if the county could continue to deny its citizens public education. Investigating this remarkable and nearly forgotten story of local, state, and…

  15. Personality disorder features as predictors of symptoms five years post-treatment.

    Science.gov (United States)

    Jansson, Irene; Hesse, Morten; Fridell, Mats

    2008-01-01

    Personality disorders are associated with dysfunction in a variety of areas. Recent longitudinal research has shown that personality disorders are also predictive of problems later in life, as well as of poor response to treatment of depression and anxiety. This study assessed whether personality disorder features were associated with psychiatric symptoms in a cohort of women treated for substance abuse in Sweden. Patients were diagnosed with personality disorders using the Structured Clinical Interview for DSM-IV (SCID-II) personality questionnaire and SCID-II interview, and were then administered a self-report questionnaire designed to measure symptoms of psychiatric illness, the Symptoms Checklist-90 (SCL-90), during and five years after treatment. Concurrently, features of all personality disorders, except histrionic, were associated with SCL-90 score. At five-year follow-up, most personality disorders remained associated with SCL-90 score, with the exception of paranoid and schizoid personality disorder. After controlling for baseline score on the SCL-90, conduct disorder, borderline personality disorder, and narcissistic personality disorder remained significantly associated with symptoms at follow-up. After controlling for abstinence and baseline score, only borderline personality disorder features remained associated with SCL-90 score at follow-up. Patients with personality disorders should be monitored after treatment for psychiatric symptoms.

  16. Mathematical descriptions of a one- and five-year old child for use in dosimetry calculations

    Energy Technology Data Exchange (ETDEWEB)

    Hwang, J.M.L.; Shoup, R.L.; Warner, G.G.; Poston, J.W.

    1976-03-01

    Mathematical representations for estimating the absorbed radiation dose from external and internal radiation sources of a one-year old and a five-year old human have been designed. The phantoms used consist of head, trunk and leg regions with a skeletal system and twenty-two internal organs, each. The mathematical descriptions of these phantoms have been coded into Fortran computer language for use with a Monte-Carlo photon transport code. This computer code was used to calculate absorbed fractions of energy deposited in different targets organs from a radionuclide deposited uniformly in a source organ. Absorbed dose calculations were performed for two /sup 99m/Tc-labeled pharmaceuticals. Photon absorbed fraction estimates for the pediatric phantoms from Monte-Carlo calculations were combined with biological data to estimate dose distributions in one-year old and five-year old children. (CH)

  17. Mathematical descriptions of a one- and five-year old child for use in dosimetry calculations

    International Nuclear Information System (INIS)

    Hwang, J.M.L.; Shoup, R.L.; Warner, G.G.; Poston, J.W.

    1976-03-01

    Mathematical representations for estimating the absorbed radiation dose from external and internal radiation sources of a one-year old and a five-year old human have been designed. The phantoms used consist of head, trunk and leg regions with a skeletal system and twenty-two internal organs, each. The mathematical descriptions of these phantoms have been coded into Fortran computer language for use with a Monte-Carlo photon transport code. This computer code was used to calculate absorbed fractions of energy deposited in different targets organs from a radionuclide deposited uniformly in a source organ. Absorbed dose calculations were performed for two /sup 99m/Tc-labeled pharmaceuticals. Photon absorbed fraction estimates for the pediatric phantoms from Monte-Carlo calculations were combined with biological data to estimate dose distributions in one-year old and five-year old children

  18. Five years after Fukushima, it's time to seize new nuclear opportunities

    Energy Technology Data Exchange (ETDEWEB)

    Shephers, John [nuclear24, Redditch (United Kingdom)

    2016-05-15

    In March of this year, we marked a painful chapter in the history of the world's civil nuclear energy industry as we reflected on the earthquake and tsunami that struck Japan five years ago - leading to the nuclear accident at Fukushima-Daiichi. In moving on, the nuclear industry needs to absorb the lessons learned from Fukushima and there are now clear signals for going on with nuclear.

  19. High level of viral suppression and low switch rate to second-line antiretroviral therapy among HIV-infected adult patients followed over five years: retrospective analysis of the DART trial.

    Directory of Open Access Journals (Sweden)

    Cissy Kityo

    Full Text Available In contrast to resource-rich countries, most HIV-infected patients in resource-limited countries receive treatment without virological monitoring. There are few long-term data, in this setting, on rates of viral suppression or switch to second-line antiretroviral therapy. The DART trial compared clinically driven monitoring (CDM versus routine laboratory (CD4/haematology/biochemistry and clinical monitoring (LCM in HIV-infected adults initiating therapy. There was no virological monitoring in either study group during follow-up, but viral load was measured in Ugandan participants at trial closure. Two thousand three hundred and seventeen (2317 participants from this country initiated antiretroviral therapy with zidovudine/lamivudine plus tenofovir (n = 1717, abacavir (n = 300, or nevirapine (n = 300. Of 1896 (81.8% participants who were alive and in follow-up at trial closure (median 5.1 years after therapy initiation, 1507 (79.5% were on first-line and 389 (20.5% on second-line antiretroviral therapy. The overall switch rate after the first year was 5.6 per 100 person-years; the rate was substantially higher in participants with low baseline CD4 counts (<50 cells/mm3. Among 1207 (80.1% first-line participants with viral load measured, HIV RNA was <400 copies/ml in 963 (79.8%, 400-999 copies/ml in 37 (3.1%, 1,000-9,999 copies/ml in 110 (9.1%, and ≥10,000 copies/ml in 97 (8.0%. The proportion with HIV RNA <400 copies/ml was slightly lower (difference 7.1%, 95% CI 2.5 to 11.5% in CDM (76.3% than in LCM (83.4%. Among 252 (64.8% second-line participants with viral load measured (median 2.3 years after switch, HIV RNA was <400 copies/ml in 226 (89.7%, with no difference between monitoring strategies. Low switch rates and high, sustained levels of viral suppression are achievable without viral load or CD4 count monitoring in the context of high-quality clinical care.ISRCTN13968779.

  20. Ten Years Back, Five Years Forward: The Data Seal of Approval

    Directory of Open Access Journals (Sweden)

    Ingrid Dillo

    2015-02-01

    Full Text Available If we want to share data, the long-term storage of those data in a trustworthy digital archive is an essential condition. Trust is the basis of storing and sharing data. That trust must be present in the various stakeholders involved. Certification of digital archives can make an important contribution to the confidence of these stakeholders in the digital archives.Ten years ago DANS was assigned the task of developing a Seal of Approval for digital data to ensure that archived data can still be found, understood and used in the future. In 2009 this Data Seal of Approval (DSA was transferred to an international body, the DSA Board, which has managed and further developed the guidelines and the peer review process ever since.The objectives of the DSA are to safeguard data, ensure high quality and guide reliable management of data for the future without requiring implementation of new standards, regulations or heavy investments. The DSA contains 16 guidelines for applying and verifying quality aspects concerning the creation, storage, use and reuse of digital data.Based on feedback from data archives that applied for a DSA and different case studies we have gained some insight into the benefits of DSA. Still, the impact of having the Seal is not easy to measure. Seal holders usually refer to qualitative benefits in the form of increased awareness of the value of their repositories to their communities, funders and publishers.Ten years down the line we can safely state that the Data Seal of Approval has proven its added value. If we try to look five years into the future, what can we expect? There are different developments: a growing interest in DSA among European research infrastructures, the collaboration between DSA and the ISCU World Data System under the umbrella of the RDA (Research Data Alliance and the European Commission is showing a growing interest in certification services.The success of DSA also provides the challenge to further

  1. The U.S.-Singapore Free Trade Agreement: Effects After Five Years

    Science.gov (United States)

    2010-03-26

    U.S. service providers in Singapore under the FTA , Citibank has been able to expand its operations there (it has 50% of the credit card market...failing to comply with a collection of information if it does not display a currently valid OMB control number. 1. REPORT DATE 26 MAR 2010 2. REPORT...U.S.-Singapore Free Trade Agreement: Effects After Five Years Congressional Research Service Summary The U.S.-Singapore Free Trade Agreement ( FTA

  2. Collaboration on DIII-D Five Year Plan

    International Nuclear Information System (INIS)

    Allen, S

    2003-01-01

    This document summarizes Lawrence Livermore National Laboratory's (LLNL) plan for fusion research on the DIII-D Tokamak, located at General Atomics (GA) in San Diego, California, in the time period FY04-FY08. This document is a companion document to the DIII-D Five-Year Program Plan; which hereafter will be referred to as the ''D3DPP''. The LLNL Collaboration on DIII-D is a task-driven program in which we bring to bear the full range of expertise needed to complete specific goals of plasma science research on the DIII-D facility. This document specifies our plasma performance and physics understanding goals and gives detailed plans to achieve those goals in terms of experimental leadership, code development and analysis, and diagnostic development. Our program is designed to be consistent with the long-term mission of the DIII-D program as documented in the D3DPP. The overall DIII-D Program mission is ''to establish the scientific basis for the optimization of the tokamak approach to fusion energy production''. LLNL Magnetic Fusion Energy (MFE) supports this mission, and we contribute to two areas of the DIII-D program: divertor physics and advanced tokamak (AT) physics. We lead or contribute to the whole cycle of research: experimental planning, diagnostic development, execution of experiments, and detailed analysis. We plan to continue this style in the next five years. DIII-D has identified three major research themes: AT physics, confinement physics, and mass transport. The LLNL program is part of the AT theme: measurement of the plasma current profile, and the mass transport theme: measurement and modeling of plasma flow. In the AT area, we have focused on the measurement and modeling of the current profile in Advanced Tokamak plasmas. The current profile, and it's effect on MHD stability of the high-β ''AT'' plasma are at the heart of the DIII-D program. LLNL has played a key role in the development of the Motional Stark Effect (MSE) diagnostic. Starting

  3. Physical activity across the curriculum: year one process evaluation results

    Directory of Open Access Journals (Sweden)

    Sullivan Debra K

    2008-07-01

    Full Text Available Abstract Background Physical Activity Across the Curriculum (PAAC is a 3-year elementary school-based intervention to determine if increased amounts of moderate intensity physical activity performed in the classroom will diminish gains in body mass index (BMI. It is a cluster-randomized, controlled trial, involving 4905 children (2505 intervention, 2400 control. Methods We collected both qualitative and quantitative process evaluation data from 24 schools (14 intervention and 10 control, which included tracking teacher training issues, challenges and barriers to effective implementation of PAAC lessons, initial and continual use of program specified activities, and potential competing factors, which might contaminate or lessen program effects. Results Overall teacher attendance at training sessions showed exceptional reach. Teachers incorporated active lessons on most days, resulting in significantly greater student physical activity levels compared to controls (p Conclusion In the first year of the PAAC intervention, process evaluation results were instrumental in identifying successes and challenges faced by teachers when trying to modify existing academic lessons to incorporate physical activity.

  4. Attempted suicide in Denmark. IV. A five-year follow-up

    DEFF Research Database (Denmark)

    Nielsen, B; Wang, A G; Brille-Brahe, U

    1990-01-01

    contact with the psychiatric ward. Predictors for future suicide were chronic somatic disease, depression, abuse of medicine, and chronic alcohol abuse. The authors emphasize the need for a thorough medical evaluation of patients attempting suicide, to be able to identify and eventually treat......From October 1, 1980 to April 20, 1981, 207 patients were admitted to the Department of Psychiatry, Odense University Hospital, after attempting suicide. Information on physical, mental and social conditions was collected. The patients were then followed for 5 years, to register subsequent suicidal...... behaviour and to try to identify relevant factors for evaluation of future suicide risk. During the follow-up period 11.6% of the attempters committed suicide, the majority within the first year after the index attempt. Seventy-five percent of the suicides were committed less than 6 months after the last...

  5. A five-year follow-up study of Swedish adults with gender identity disorder.

    Science.gov (United States)

    Johansson, Annika; Sundbom, Elisabet; Höjerback, Torvald; Bodlund, Owe

    2010-12-01

    This follow-up study evaluated the outcome of sex reassignment as viewed by both clinicians and patients, with an additional focus on the outcome based on sex and subgroups. Of a total of 60 patients approved for sex reassignment, 42 (25 male-to-female [MF] and 17 female-to-male [FM]) transsexuals completed a follow-up assessment after 5 or more years in the process or 2 or more years after completed sex reassignment surgery. Twenty-six (62%) patients had an early onset and 16 (38%) patients had a late onset; 29 (69%) patients had a homosexual sexual orientation and 13 (31%) patients had a non-homosexual sexual orientation (relative to biological sex). At index and follow-up, a semi-structured interview was conducted. At follow-up, 32 patients had completed sex reassignment surgery, five were still in process, and five-following their own decision-had abstained from genital surgery. No one regretted their reassignment. The clinicians rated the global outcome as favorable in 62% of the cases, compared to 95% according to the patients themselves, with no differences between the subgroups. Based on the follow-up interview, more than 90% were stable or improved as regards work situation, partner relations, and sex life, but 5-15% were dissatisfied with the hormonal treatment, results of surgery, total sex reassignment procedure, or their present general health. Most outcome measures were rated positive and substantially equal for MF and FM. Late-onset transsexuals differed from those with early onset in some respects: these were mainly MF (88 vs. 42%), older when applying for sex reassignment (42 vs. 28 years), and non-homosexually oriented (56 vs. 15%). In conclusion, almost all patients were satisfied with the sex reassignment; 86% were assessed by clinicians at follow-up as stable or improved in global functioning.

  6. Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial.

    Science.gov (United States)

    Livi, Lorenzo; Meattini, Icro; Marrazzo, Livia; Simontacchi, Gabriele; Pallotta, Stefania; Saieva, Calogero; Paiar, Fabiola; Scotti, Vieri; De Luca Cardillo, Carla; Bastiani, Paolo; Orzalesi, Lorenzo; Casella, Donato; Sanchez, Luis; Nori, Jacopo; Fambrini, Massimiliano; Bianchi, Simonetta

    2015-03-01

    Accelerated partial breast irradiation (APBI) has been introduced as an alternative treatment method for selected patients with early stage breast cancer (BC). Intensity-modulated radiotherapy (IMRT) has the theoretical advantage of a further increase in dose conformity compared with three-dimensional techniques, with more normal tissue sparing. The aim of this randomised trial is to compare the local recurrence and survival of APBI using the IMRT technique after breast-conserving surgery to conventional whole-breast irradiation (WBI) in early stage BC. This study was performed at the University of Florence (Florence, Italy). Women aged more than 40years affected by early BC, with a maximum pathological tumour size of 25mm, were randomly assigned in a 1:1 ratio to receive either WBI or APBI using IMRT. Patients in the APBI arm received a total dose of 30 Gy to the tumour bed in five daily fractions. The WBI arm received 50Gy in 25 fractions, followed by a boost on the tumour bed of 10Gy in five fractions. The primary end-point was occurrence of ipsilateral breast tumour recurrences (IBTRs); the main analysis was by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT02104895. A total of 520 patients were randomised (260 to external WBI and 260 to APBI with IMRT) between March 2005 and June 2013. At a median follow-up of 5.0 years (Interquartile Range (IQR) 3.4-7.0), the IBTR rate was 1.5% (three cases) in the APBI group (95% confidence interval (CI) 0.1-3.0) and in the WBI group (three cases; 95% CI 0.0-2.8). No significant difference emerged between the two groups (log rank test p=0.86). We identified seven deaths in the WBI group and only one in the APBI group (p=0.057). The 5-year overall survival was 96.6% for the WBI group and 99.4% for the APBI group. The APBI group presented significantly better results considering acute (p=0.0001), late (p=0.004), and cosmetic outcome (p=0.045). To our knowledge, this is the first randomised

  7. Two-Year COMPASS Trial Results: Supraciliary Microstenting with Phacoemulsification in Patients with Open-Angle Glaucoma and Cataracts.

    Science.gov (United States)

    Vold, Steven; Ahmed, Iqbal Ike K; Craven, E Randy; Mattox, Cynthia; Stamper, Robert; Packer, Mark; Brown, Reay H; Ianchulev, Tsontcho

    2016-10-01

    We evaluated 2-year safety and efficacy of supraciliary microstenting (CyPass Micro-Stent; Transcend Medical, Inc., Menlo Park, CA) for treating mild-to-moderate primary open-angle glaucoma (POAG) in patients undergoing cataract surgery. Multicenter (24 US sites), interventional randomized clinical trial (RCT) (ClinicalTrials.gov identifier, NCT01085357). Subjects were enrolled beginning July 2011, with study completion in March 2015. Subjects had POAG with mean diurnal unmedicated intraocular pressure (IOP) 21-33 mmHg and were undergoing phacoemulsification cataract surgery. After completing cataract surgery, subjects were intraoperatively randomized to phacoemulsification only (control) or supraciliary microstenting with phacoemulsification (microstent) groups (1:3 ratio). Microstent implantation via an ab interno approach to the supraciliary space allowed concomitant cataract and glaucoma surgery. Outcome measures included percentage of subjects achieving ≥20% unmedicated diurnal IOP lowering versus baseline, mean IOP change and glaucoma medication use, and ocular adverse event (AE) incidence through 24 months. Of 505 subjects, 131 were randomized to the control group and 374 were randomized to the microstent group. Baseline mean IOPs in the control and microstent groups were similar: 24.5±3.0 and 24.4±2.8 mmHg, respectively (P > 0.05); mean medications were 1.3±1.0 and 1.4±0.9, respectively (P > 0.05). There was early and sustained IOP reduction, with 60% of controls versus 77% of microstent subjects achieving ≥20% unmedicated IOP lowering versus baseline at 24 months (P = 0.001; per-protocol analysis). Mean IOP reduction was ↓7.4 mmHg for the microstent group versus ↓5.4 mmHg in controls (P control versus 85% of microstent subjects were medication free. Mean medication use in controls decreased from 1.3±1.0 drugs at baseline to 0.7±0.9 and 0.6±0.8 drugs at 12 and 24 months, respectively, and in the microstent group from 1.4±0.9 to 0.2±0

  8. Five years audit for presence of toxic agents/drug of abuse at autopsy

    International Nuclear Information System (INIS)

    Ali, S.M.A.; Khalil, I.R.; Saeed, A.; Hussain, Z.

    2003-01-01

    Objective: To know the frequency of fatal poisoning in Peshawar regarding the toxic agents mostly involved and year wise percentage. To know the age group and the gender that is most vulnerable to fatal poisoning. Results: Poisoning was the cause of death in 1.48% of the total autopsies conducted during the five years. Males were more involved than the females, 90.38%. Suicidal poisoning was present in 17.30% of the total cases and accidental poisoning was found in 80.72% cases, while homicidal cases were 1.29% only. Diacetylmorphine (heroin) was the most commonly involved agent, 65.38%, of the total cases. The incidence of poisoning was more during the third and fourth decades of life. Conclusion: Diacetylmorphine (heroin) was the main causative agent involved in young males due to accidental over-dosage. Accidental and suicidal deaths should not be considered as inevitable. More elaborative studies are required in this area of recent research to adopt appropriate and adequate measures to save precious lives.(author)

  9. Feasibility and acceptability of conducting HIV vaccine trials in adolescents in South Africa: Going beyond willingness to participate towards implementation

    Directory of Open Access Journals (Sweden)

    M Wallace

    2018-03-01

    Full Text Available Background. HIV/AIDS remains a leading cause of death in adolescents (aged 15 - 25 years, and in sub-Saharan Africa HIV-related deaths continue to rise in this age group despite a decline in both adult and paediatric populations. This is attributable in part to high adolescent infection rates and supports the urgent need for more efficacious prevention strategies. In particular, an even partially effective HIV vaccine, given prior to sexual debut, is predicted to significantly curb adolescent infection rates. While adolescents have indicated willingness to participate in HIV vaccine trials, there are concerns around safety, uptake, adherence, and ethical and logistic issues.Objectives. To initiate a national, multisite project with the aim of identifying obstacles to conducting adolescent HIV vaccine trials in South Africa (SA.Method. A simulated HIV vaccine trial was conducted in adolescents aged 12 - 17 years across five SA research sites, using the already licensed Merck human papillomavirus vaccine Gardasil as a proxy for an HIV vaccine. Adolescents were recruited at community venues and, following a vaccine discussion group, invited to participate in the trial. Consent for trial enrolment was obtained from a parent or legal guardian, and participants aged 16 - 17 years were eligible only if sexually active. Typical vaccine trial procedures were applied during the five study visits, including the administration of vaccination injections at study visits 2, 3 and 4.Results. The median age of participants was 14 years (interquartile range 13 - 15, with 81% between the ages of 12 and 15 years at enrolment. Overall, 98% of screened participants opted to receive the vaccine, 588 participants enrolled, and 524 (89% attended the final visit.Conclusions. This trial showed that adolescents can be recruited, enrolled and retained in clinical prevention trials with parental support. While promising, these results were tempered by the coupling of sexual

  10. Public health in Kosovo after five difficult years of independence

    Directory of Open Access Journals (Sweden)

    Naim Jerliu

    2015-12-01

    administration. Regarding the health status, five years after independence, compared with other European countries, post-war transitional Kosovo is still characterized by higher mortality rates including traditional public health problems pertinent to infant mortality and maternal deaths. In parallel, however, Kosovo is undergoing a rapid process of epidemiological transition characterized by an aging trend which is inevitably coupled with high cardiovascular and cancer mortality and morbidity along with an excess mortality in external causes of death and injuries among the adult population. Adoption of the new Health Law in December 2012 by the Kosovo Assembly aims the transition from centralized health care system established under emergency conditions of the post-war period towards a contemporary modern health care system with a clear purchaser-provider split based on a high transparency and accountability of the health care providers and their contractors. The health care reform, leading eventually to significant changes within the health sector in Kosovo, consists of two main pillars: (i structural and functional reorganization of the health care system through establishment of Kosovo Health Service (an autonomous and non-for-profit public enterprise at central level of the health care sector, and; (ii establishment for the first time of the public health insurance system with a Health Insurance Fund as its main body. Nevertheless, five years after declaration of independence, Kosovo, the newest state in Europe consisting of the youngest population, is currently facing a particularly difficult socioeconomic and political transition and is additionally struggling and mainstreaming all energies and efforts in order to get full international recognition.

  11. Competitive Employment for Youth with Autism Spectrum Disorders: Early Results from a Randomized Clinical Trial

    Science.gov (United States)

    Wehman, Paul H.; Schall, Carol M.; McDonough, Jennifer; Kregel, John; Brooke, Valerie; Molinelli, Alissa; Ham, Whitney; Graham, Carolyn W.; Riehle, J. Erin; Collins, Holly T.; Thiss, Weston

    2014-01-01

    For most youth with autism spectrum disorders (ASD), employment upon graduation from high school or college is elusive. Employment rates are reported in many studies to be very low despite many years of intensive special education services. This paper presented the preliminary results of a randomized clinical trial of Project SEARCH plus ASD…

  12. A Dietary Intervention in Urban African Americans: Results of the "Five Plus Nuts and Beans" Randomized Trial.

    Science.gov (United States)

    Miller, Edgar R; Cooper, Lisa A; Carson, Kathryn A; Wang, Nae-Yuh; Appel, Lawrence J; Gayles, Debra; Charleston, Jeanne; White, Karen; You, Na; Weng, Yingjie; Martin-Daniels, Michelle; Bates-Hopkins, Barbara; Robb, Inez; Franz, Whitney K; Brown, Emily L; Halbert, Jennifer P; Albert, Michael C; Dalcin, Arlene T; Yeh, Hsin-Chieh

    2016-01-01

    Unhealthy diets, often low in potassium, likely contribute to racial disparities in blood pressure. We tested the effectiveness of providing weekly dietary advice, assistance with selection of higher potassium grocery items, and a $30 per week food allowance on blood pressure and other outcomes in African American adults with hypertension. We conducted an 8-week RCT with two parallel arms between May 2012 and November 2013. We randomized 123 African Americans with controlled hypertension from an urban primary care clinic in Baltimore, Maryland, and implemented the trial in partnership with a community supermarket and the Baltimore City Health Department. Mean (SD) age was 58.6 (9.5) years; 71% were female; blood pressure was 131.3 (14.7)/77.2 (10.5) mmHg; BMI was 34.5 (8.2); and 28% had diabetes. Participants randomized to the active intervention group (Dietary Approaches to Stop Hypertension [DASH]-Plus) received coach-directed dietary advice and assistance with weekly online ordering and purchasing of high-potassium foods ($30/week) delivered by a community supermarket to a neighborhood library. Participants in the control group received a printed DASH diet brochure along with a debit account of equivalent value to that of the DASH-Plus group. The primary outcome was blood pressure change. Analyses were conducted in January to October 2014. Compared with the control group, the DASH-Plus group increased self-reported consumption of fruits and vegetables (mean=1.4, 95% CI=0.7, 2.1 servings/day); estimated intake of potassium (mean=0.4, 95% CI=0.1, 0.7 grams/day); and urine potassium excretion (mean=19%, 95% CI=1%, 38%). There was no significant effect on blood pressure. A program providing dietary advice, assistance with grocery ordering, and $30/week of high-potassium foods in African American patients with controlled hypertension in a community-based clinic did not reduce BP. However, the intervention increased consumption of fruits, vegetables, and urinary

  13. [Efficacy of racecadotril vs. smectite, probiotics or zinc as an integral part of treatment of acute diarrhea in children under five years: A meta-analysis of multiple treatments].

    Science.gov (United States)

    Gutiérrez-Castrellón, Pedro; Ortíz-Hernández, Anna Alejandra; Llamosas-Gallardo, Beatriz; Acosta-Bastidas, Mario A; Jiménez-Gutiérrez, Carlos; Diaz-García, Luisa; Anzo-Osorio, Anahí; Estevez-Jiménez, Juliana; Jiménez-Escobar, Irma; Vidal-Vázquez, Rosa Patricia

    2015-01-01

    Despite major advances in treatment, acute diarrhea continues to be a public health problem in children under five years. There is no systematic approach to treatment and most evidence is assembled comparing active treatment vs. placebo. Systematic review of evidence on efficacy of adjuvants for treatment of acute diarrhea through a network meta-analysis. A systematic search of multiple databases searching clinical trials related to the use of racecadotril, smectite, Lactobacillus GG, Lactobacillus reuteri, Saccharomyces boulardii and zinc as adjuvants in acute diarrhea was done. The primary endpoint was duration of diarrhea. Information is displayed through network meta-analysis.The superiority of each coadjutant was analyzed by Sucra approach. Network meta-analysis showed race cadotril was better when compared with placebo and other adjuvants. Sucra analysis showed racecadotril as the first option followed by smectite and Lactobacillus reuteri. Considering a strategic decision making approach, network meta-analysis allows us to establish the therapeutic superiority of racecadotril as an adjunct for the comprehensive management of acute diarrhea in children aged less than five years.

  14. Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial

    OpenAIRE

    Rushing, J.; Wing, R.; Wadden, T. A.; Knowler, W. C.; Lawlor, M.; Evans, M.; Killean, T.; Montez, M.; Espeland, M. A.; Zhang, P.

    2017-01-01

    Summary Objective The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10?years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention. Methods The ...

  15. Five years' experience of the new SAPs: overview and way forward

    International Nuclear Information System (INIS)

    Pape, R.P.

    1998-01-01

    This paper gives an overview of the five years' experience gained in applying the new safety assessment principles (SAPs). Beginning with a brief history of SAPs, it goes on to discuss their structure and their relevance to safety matters. It develops some of the more basic issues which users have to bear in mind and also considers how SAPs are used by NII. Finally, there is a look forward to future developments in SAPs usage and application. (author)

  16. Dutch iliac stent trial : Long-term results in patients randomized for primary or selective stent placement

    NARCIS (Netherlands)

    Klein, W.M.; van der Graaf, Y.; Seegers, J.; Spithoven, J.H.; Buskens, E.; van Baal, J.G.; Buth, J.; Moll, F.L.; Overtoom, T.T.C.; van Sambeek, M.R.H.M.; Mali, W.P.T.M.

    Purpose: To determine long-term results of the prospective Dutch Iliac Stent Trial. Materials and Methods: The study protocol was approved by local institutional review boards. All patients gave written informed consent. Two hundred seventy-nine patients (201 men, 78 women; mean age, 58 years) with

  17. Seroepizootology of Q fever in Bulgaria during the last five years.

    Science.gov (United States)

    Martinov, S P; Pandarov, S; Popov, G V

    1989-12-01

    The work presents results of investigations on Q fever seroepizootology in Bulgaria during the last five years. These data are compared with the preceding period from 1950 to 1983. The basic method for investigation is Complement fixation test. Also used are immunofluorescence, agglutination reaction, cultivation and direct Electron microscopy. In general 15,814 samples were tested. Q fever positivity was foundin 10.08% of cattle, 20.44% of sheep, 10.17% of goats, 59.25% of dogs, 26.66% of magpies, 11.11% of wood-pigeons, 7.40% of mouflons, 7.14% of foxes and 5.82% of hens. These data confirm the results of our preceding investigations for the wide dissemination of C. burnetti among domestic animals. Positive data for the significant spread of C. burnetti among the wild animals and birds also exists. The disease manifests itself clinically in abortions in sheep and cattle and mastitis in sheep. The inapparent form, however, is much more frequent. The infected dogs represent a special interest. The control measures are based on the wide use of tetracyclines. The presented data testify to the continuing importance of the problem of Q fever in Bulgaria.

  18. Irritable bowel syndrome and functional abdominal pain in five-year-old children are related to lifestyle.

    Science.gov (United States)

    Uusijärvi, Agneta; Alm, Johan; Lindblad, Frank; Olén, Ola

    2016-08-01

    Abdominal pain of functional origin is very common in childhood, and environmental factors are thought to be of aetiologic importance. The anthroposophic lifestyle has dietary and lifestyle characteristics that may influence child health, and this study aimed to assess the effect of such lifestyles on abdominal pain of functional origin. A prospective Swedish lifestyle cohort (n = 470) was followed from birth to five years of age. Family lifestyles were characterised through questionnaires. Abdominal pain was defined as irritable bowel syndrome or functional abdominal pain according to the Rome III criteria and measured with parental questionnaires and interviews at the age of five. The prevalence of abdominal pain was 15%. Children were more likely to have abdominal pain at five years of age if their family had a partly anthroposophic lifestyle, with an adjusted odds ratio (OR) of 2.61 (95% CI 1.15-5.93), or an anthroposophic lifestyle, with an adjusted OR of 2.34 (95% CI 0.96-5.70). A family lifestyle with anthroposophic characteristics was associated with an increased risk of abdominal pain in five-year-old children. The mechanisms for this increase were unclear, but we speculate that there may have been different prerequisites for coping with stressors. ©2016 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

  19. Similar Occurrence of Febrile Episodes Reported in Non-Atopic Children at Three to Five Years of Age after Prebiotics Supplemented Infant Formula

    NARCIS (Netherlands)

    van Stuijvenberg, Margriet; Stam, Jose; Grueber, Christoph; Mosca, Fabio; Arslanoglu, Sertac; Chirico, Gaetano; Braegger, Christian P.; Riedler, Josef; Boehm, Guenther; Sauer, Pieter J. J.

    2015-01-01

    This is a follow up study of a multicenter randomised placebo-controlled trial in seven centres in five West European countries. The RCT assessed the effect of infant formula supplemented with a mixture of prebiotics (with neutral short-chain and long-chain oligosaccharides and pectin-derived acidic

  20. Pacific Northwest and Alaska Regional Bioenergy Program : Five Year Report, 1985-1990.

    Energy Technology Data Exchange (ETDEWEB)

    Pacific Northwest and Alaska Bioenergy Program (U.S.)

    1991-02-01

    This five-year report describes activities of the Pacific Northwest and Alaska Regional Bioenergy Program between 1985 and 1990. Begun in 1979, this Regional Bioenergy Program became the model for the nation's four other regional bioenergy programs in 1983. Within the time span of this report, the Pacific Northwest and Alaska Regional Bioenergy Program has undertaken a number of applied research and technology projects, and supported and guided the work of its five participating state energy programs. During this period, the Regional Bioenergy Program has brought together public- and private-sector organizations to promote the use of local biomass and municipal-waste energy resources and technologies. This report claims information on the mission, goals and accomplishments of the Regional Bioenergy Program. It describes the biomass projects conducted by the individual states of the region, and summarizes the results of the programs technical studies. Publications from both the state and regional projects are listed. The report goes on to consider future efforts of the Regional Bioenergy Program under its challenging assignment. Research activities include: forest residue estimates; Landsat biomass mapping; woody biomass plantations; industrial wood-fuel market; residential space heating with wood; materials recovery of residues; co-firing wood chips with coal; biomass fuel characterization; wood-boosted geothermal power plants; wood gasification; municipal solid wastes to energy; woodstove study; slash burning; forest depletion; and technology transfer. 9 figs., 6 tabs.

  1. Monsters, Big Monsters, and Really Big Monsters; The Self-Reported Fears of Three-, Four-, and Five-Year-Old Children.

    Science.gov (United States)

    Robinson, Sandra L.; Gladstone, Delinda H.

    1993-01-01

    Reports the results of interviews with three-, four-, and five-year-old children at various child care centers in Columbia, South Carolina, concerning their fears. The fear of "monsters" was most often reported. Suggests what parents and teachers can do to help children cope with their fears. (BB)

  2. The treatment of disc herniation-induced sciatica with infliximab - One-year follow-up results of FIRST II, a randomized controlled trial

    NARCIS (Netherlands)

    Korhonen, Timo; Karppinen, Jaro; Paimela, Leena; Malmivaara, Antti; Lindgren, Karl-August; Bowman, Chris; Hammond, Anthony; Kirkham, Bruce; Jarvinen, Simo; Niinimaki, Jaakko; Veeger, Nic; Haapea, Marianne; Torkki, Markus; Tervonen, Osmo; Seitsalo, Seppo; Hurri, Heikki

    2006-01-01

    Study Design. A randomized controlled trial. Objectives. To evaluate the long-term efficacy of infliximab, a monoclonal antibody against tumor necrosis factor alpha (TNF-alpha), in patients with acute/subacute sciatica secondary to herniated disc. Summary of Background Data. The results of

  3. Effect of household-based drinking water chlorination on diarrhoea among children under five in Orissa, India: a double-blind randomised placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    Sophie Boisson

    2013-08-01

    Full Text Available Boiling, disinfecting, and filtering water within the home can improve the microbiological quality of drinking water among the hundreds of millions of people who rely on unsafe water supplies. However, the impact of these interventions on diarrhoea is unclear. Most studies using open trial designs have reported a protective effect on diarrhoea while blinded studies of household water treatment in low-income settings have found no such effect. However, none of those studies were powered to detect an impact among children under five and participants were followed-up over short periods of time. The aim of this study was to measure the effect of in-home water disinfection on diarrhoea among children under five.We conducted a double-blind randomised controlled trial between November 2010 and December 2011. The study included 2,163 households and 2,986 children under five in rural and urban communities of Orissa, India. The intervention consisted of an intensive promotion campaign and free distribution of sodium dichloroisocyanurate (NaDCC tablets during bi-monthly households visits. An independent evaluation team visited households monthly for one year to collect health data and water samples. The primary outcome was the longitudinal prevalence of diarrhoea (3-day point prevalence among children aged under five. Weight-for-age was also measured at each visit to assess its potential as a proxy marker for diarrhoea. Adherence was monitored each month through caregiver's reports and the presence of residual free chlorine in the child's drinking water at the time of visit. On 20% of the total household visits, children's drinking water was assayed for thermotolerant coliforms (TTC, an indicator of faecal contamination. The primary analysis was on an intention-to-treat basis. Binomial regression with a log link function and robust standard errors was used to compare prevalence of diarrhoea between arms. We used generalised estimating equations to account

  4. Endeavour zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent : 4-year results of the PROTECT randomized trial

    NARCIS (Netherlands)

    Wijns, William; Steg, Ph. Gabriel; Mauri, Laura; Kurowski, Volkhard; Parikh, Keyur; Gao, Runlin; Bode, Christoph; Greenwood, John P.; Lipsic, Erik; Alamgir, Farqad; Rademaker-Havinga, Tessa; Boersma, Eric; Radke, Peter; van Leeuwen, Frank; Camenzind, Edoardo

    2014-01-01

    Aims To compare the long-term clinical safety between two drug-eluting stents with different healing characteristics in the Patient Related Outcomes with Endeavour (E-ZES) vs. Cypher (C-SES) Stenting Trial (PROTECT). At 3 years, there was no difference in the primary outcome of definite or probable

  5. Long-Term Results After Simple Versus Complex Stenting of Coronary Artery Bifurcation Lesions Nordic Bifurcation Study 5-Year Follow-Up Results

    DEFF Research Database (Denmark)

    Maeng, M.; Holm, N. R.; Erglis, A.

    2013-01-01

    Objectives This study sought to report the 5-year follow-up results of the Nordic Bifurcation Study. Background Randomized clinical trials with short-term follow-up have indicated that coronary bifurcation lesions may be optimally treated using the optional side branch stenting strategy. Methods...... complex strategy of planned stenting of both the main vessel and the side branch. (C) 2013 by the American College of Cardiology Foundation...

  6. Meta-analysis of five photodisinfection clinical trials for periodontitis

    Science.gov (United States)

    Andersen, Roger C.; Loebel, Nicolas G.; Andersen, Dane M.

    2009-06-01

    Photodynamic therapy(PDT) has been demonstrated to effectively kill human periopathogens in vitro. To evaluate the efficacy of PDT in vivo a series of clinical trials was carried out in multiple centers and populations. Clinical parameters including clinical attachment level, pocket probing depth and bleeding on probing were all evaluated. All groups received the standard of care, scaling and root planing, and the treatment group additionally received a single treatment of PDT. Of the total 309 patients and over 40,000 pockets treated in these 5 trials it was determined that photodynamic therapy provided a statistically significant improvement in clinical parameters over scaling and root planing alone.

  7. FORMakademisk – Fem års jubileum - Five years anniversary

    Directory of Open Access Journals (Sweden)

    Janne Beate Reitan

    2013-01-01

    Full Text Available When we first published FORMakademisk five years ago, we stated in the very first editorial on page 1 in Volume 1, Issue 1 that:The aim of the journal is to provide a venue for research in design and design education, and thereby develop an interest and working community of scholars in the field. The editorial team perceives design as a generic term that includes creative and performing activities in the great span of the artefacts ‘from the spoon to the city’. The editorial team relates to design education as a field that includes the dissemination of design in society and the teaching of design at all levels general education, vocational preparation, professional education and research education—from kindergarten to doctorate.Since then we have published two issues every year, nine all together, with more than 50 articles. The editorial team saw that future contributors to FORMakademisk would mainly be recruited from researchers within the design disciplines, and their research interests would have their roots in creative and artistic design practice. At the same time, FORMakademisk has invited scientists from established academic disciplines, when their interest has been directed towards design issues.

  8. Five years results after intrafamilial kidney post-transplant in a case of familial hypomagnesemia due to a claudin-19 mutation

    Directory of Open Access Journals (Sweden)

    Jorge Reis Almeida

    2014-09-01

    Full Text Available Introduction: Familial Hypomagnesaemia with hypercalciuria and nephrocalcinosis, with severe ocular impairment secondary to claudin-19 mutation, is a rare recessive autossomic disorder. Its spectrum includes renal Mg2+ wasting, medullary nephrocalcinosis and progressive chronic renal failure in young people. Objective: To report a case of kidney transplantation father to daughter in a familial occurrence of severe bilateral nephrocalcinosis associated with ocular impairment in a non-consanguineous Brazilian family, in which two daughters had nephrocalcinosis and severe retinopathy. Methods: The index case, a 19 years-old female, had long-lasting past medical history of recurrent urinary tract infections, and the abdominal X-ray revealed bilateral multiple renal calcifications as well as ureteral lithiasis, and she was under haemodialysis. She had the diagnosis of retinitis pigmentosa in the early neonatal period. The other daughter (13 years-old had also nephrocalcinosis with preserved kidney function, retinopathy with severe visual impairment, and in addition, she exhibited hypomagnesaemia = 0.5 mg/dL and hypercalciuria. The other family members (mother, father and son had no clinical disease manifestation. Mutation analysis at claudin-19 revealed two heterozygous missense mutations (P28L and G20D in both affected daughters. The other family members exhibited mutant monoallelic status. In despite of that, the index case underwent intrafamilial living donor kidney transplantation (father. Conclusion: In conclusion, the disease was characterized by an autosomal recessive compound heterozygous status and, after five years of donation the renal graft function remained stable without recurrence of metabolic disturbances or nephrocalcinosis. Besides, donor single kidney Mg2+ and Ca2+ homeostasis associated to monoallelic status did not affect the safety and the usual living donor post-transplant clinical course.

  9. Compliance to the prescribed dose and overall treatment time in five randomized clinical trials of altered fractionation in radiotherapy for head-and-neck carcinomas

    International Nuclear Information System (INIS)

    Khalil, Azza A.; Bentzen, Soeren M.; Bernier, Jacques; Saunders, Michele I.; Horiot, Jean-Claude; Bogaert, Walter van den; Cummings, Bernard J.; Dische, Stanley

    2003-01-01

    Purpose: To investigate compliance to the prescribed dose-fractionation schedule in five randomized controlled trials of altered fractionation in radiotherapy for head-and-neck carcinoma. Methods and Materials: Individual patient data from 2566 patients participating in the European Organization for Research and Treatment of Cancer (EORTC) 22791, EORTC 22811, EORTC 22851, Princess Margaret Hospital (PMH), and continuous hyperfractionated accelerated radiotherapy (CHART) head-and-neck trials were merged in the fractionation IMPACT (Intergroup Merger of Patient data from Altered or Conventional Treatment schedules) study database. The ideal treatment time was defined as the minimum time required to deliver a prescribed schedule. Compliance to the prescribed overall treatment time was quantified as the difference between the actual and the ideal overall time. An overall measure of compliance in an individual patient, the total dose lost (TDL), was calculated as the dose lost due to prolongation of therapy (assuming a D prolif of 0.64 Gy/day) plus the difference between the prescribed and the actual dose given. Results: The time in excess of the ideal ranged up to 97 days (average 3.9 days), and 25% of the patients had delays of 6 days or more. World Health Organization (WHO) performance status and nodal stage had a significant effect on TDL. TDL was significantly higher in the conventional than in the altered arm of the EORTC 22851 and CHART trials. In the PMH trial, TDL was significantly higher in the hyperfractionation than in the conventional arm. Centers participating in the three EORTC trials varied significantly in their compliance. There was a significant improvement in compliance in patients treated more recently. Conclusions: Even in randomized controlled trials, compliance to the prescribed radiation therapy schedule may be relatively poor, especially after conventional fractionation. This affects the interpretation of the outcome of these trials

  10. Fracture of the supraglenoid tubercle: treatment and results in five horses

    International Nuclear Information System (INIS)

    Pankowski, R.L.; Grant, B.D.; Sande, R.; Nickels, F.A.

    1986-01-01

    Five horses with fractures of the supraglenoid tubercle (tuber scapulae) were presented from 6 weeks to 1 year after injury. Clinical signs included lameness characterized by a shortened cranial phase of the stride and shoulder muscle atrophy. Radiographically, the fractures differed in the degree of cranioventral displacement of the fragment as well as the extent of joint involvement. Three horses were treated by resection of the fractured tubercle, including one using a new grid approach to the area of the fracture. Two of these horses have returned to athletic activity and one was euthanized due to postoperative infection. One horse with minimal displacement and joint involvement was treated with rest and raced successfully. One horse seen with a fracture of 1 year duration also was treated with rest and was a pasture sound broodmare

  11. Comparative effectiveness of plant-based diets for weight loss: a randomized controlled trial of five different diets.

    Science.gov (United States)

    Turner-McGrievy, Gabrielle M; Davidson, Charis R; Wingard, Ellen E; Wilcox, Sara; Frongillo, Edward A

    2015-02-01

    The aim of this study was to determine the effect of plant-based diets on weight loss. Participants were enrolled in a 6-mo, five-arm, randomized controlled trial in 2013 in South Carolina. Participants attended weekly group meetings, with the exception of the omnivorous group, which served as the control and attended monthly meetings augmented with weekly e-mail lessons. All groups attended monthly meetings for the last 4 mo of the study. Diets did not emphasize caloric restriction. Overweight adults (body mass index 25-49.9 kg/m(2); age 18-65 y, 19% non-white, and 27% men) were randomized to a low-fat, low-glycemic index diet: vegan (n = 12), vegetarian (n = 13), pesco-vegetarian (n = 13), semi-vegetarian (n = 13), or omnivorous (n = 12). Fifty (79%) participants completed the study. In intention-to-treat analysis, the linear trend for weight loss across the five groups was significant at both 2 (P vegan group (-7.5% ± 4.5%) was significantly different from the omnivorous (-3.1% ± 3.6%; P = 0.03), semi-vegetarian (-3.2% ± 3.8%; P = 0.03), and pesco-vegetarian (-3.2% ± 3.4%; P = 0.03) groups. Vegan participants decreased their fat and saturated fat more than the pesco-vegetarian, semi-vegetarian, and omnivorous groups at both 2 and 6 mo (P Vegan diets may result in greater weight loss than more modest recommendations. Copyright © 2015 Elsevier Inc. All rights reserved.

  12. Clinical outcomes of adjuvant external-beam radiotherapy for differentiated thyroid cancer. Results after 874 patient-years of follow-up in the MSDS-trial

    Energy Technology Data Exchange (ETDEWEB)

    Biermann, M. [Haukeland University Hospital, Bergen (Norway). Dept. of Radiology; Pixberg, M.K.; Riemann, B.; Schober, O. [Muenster Univ. (Germany). Dept. of Nuclear Medicine; Schuck, A.; Willich, N. [Muenster Univ. (Germany). Dept. of Radiooncology; Heinecke, A. [Muenster Univ. (Germany). Dept. of Biometrics; Schmid, K.W. [University Hospital of Essen, West German Cancer Center (Germany). Inst. of Pathology and Neuropathology; Dralle, H. [Halle-Wittenberg Univ. (Germany). Dept. of General Surgery

    2009-07-01

    Evaluate the clinical benefit of external beam radiotherapy (RTx) for locally invasive thyroid carcinoma with follicular cell differentiation (DTC). The Multicentre Study on Differentiated Thyroid Cancer (MSDS) was planned as a prospective multicenter trial on the benefit of adjuvant RTx in locally invasive DTC (pT4; UICC 1997) with or without lymph node metastases and no known distant metastases. All patients were treated with thyroidectomy, {sup 131}I-therapy, and TSH-suppression and were randomized to receive additional RTx or not. In 4/2003 the trial became a prospective cohort study after only 45 of then 311 patients had consented to randomization. 351 of 422 patients met the trial's inclusion criteria. Age was 48 {+-} 12 years (mean {+-} SD). 25% were men. Tumours were papillary in 90% and follicular in 10%. Of 47 patients randomized or allocated to RTx, 26 actually received RTx. Mean follow-up was 930 days. In an actual treatment analysis, 96% (25/26) of the RTx-patients reached complete remission (CR) vs. 86% in the non-RTx patients. Recurrences occurred in 0 vs. 3 % of patients: 6 reoperated for regional lymph node metastases, 1 tracheal invasion treated with tracheoplasty, 1 local invasion necessitating laryngectomy, 2 distant metastases (1 lung, 1 lung + bone). Serious chronic RTx toxicity occurred in 1/26 patients. The MSDS trial showed low mortality and recurrence rates and a weak benefit of RTx in terms of local control that did however not reach statistical significance. Routine RTx in locally invasive DTC can no longer be recommended. (orig.)

  13. Clinical outcomes of adjuvant external-beam radiotherapy for differentiated thyroid cancer. Results after 874 patient-years of follow-up in the MSDS-trial

    International Nuclear Information System (INIS)

    Biermann, M.; Pixberg, M.K.; Riemann, B.; Schober, O.; Schuck, A.; Willich, N.; Heinecke, A.; Schmid, K.W.; Dralle, H.

    2009-01-01

    Evaluate the clinical benefit of external beam radiotherapy (RTx) for locally invasive thyroid carcinoma with follicular cell differentiation (DTC). The Multicentre Study on Differentiated Thyroid Cancer (MSDS) was planned as a prospective multicenter trial on the benefit of adjuvant RTx in locally invasive DTC (pT4; UICC 1997) with or without lymph node metastases and no known distant metastases. All patients were treated with thyroidectomy, 131 I-therapy, and TSH-suppression and were randomized to receive additional RTx or not. In 4/2003 the trial became a prospective cohort study after only 45 of then 311 patients had consented to randomization. 351 of 422 patients met the trial's inclusion criteria. Age was 48 ± 12 years (mean ± SD). 25% were men. Tumours were papillary in 90% and follicular in 10%. Of 47 patients randomized or allocated to RTx, 26 actually received RTx. Mean follow-up was 930 days. In an actual treatment analysis, 96% (25/26) of the RTx-patients reached complete remission (CR) vs. 86% in the non-RTx patients. Recurrences occurred in 0 vs. 3 % of patients: 6 reoperated for regional lymph node metastases, 1 tracheal invasion treated with tracheoplasty, 1 local invasion necessitating laryngectomy, 2 distant metastases (1 lung, 1 lung + bone). Serious chronic RTx toxicity occurred in 1/26 patients. The MSDS trial showed low mortality and recurrence rates and a weak benefit of RTx in terms of local control that did however not reach statistical significance. Routine RTx in locally invasive DTC can no longer be recommended. (orig.)

  14. The Talar Body Prosthesis: Results at Ten to Thirty-six Years of Follow-up.

    Science.gov (United States)

    Harnroongroj, Thos; Harnroongroj, Thossart

    2014-07-16

    Satisfactory results of implantation of the talar body prosthesis were reported in 1997, although some complications associated with the initial design were noted. The present study evaluated outcomes of treatment with a modified talar body prosthesis. Of the thirty-six talar body prostheses implanted with use of a transmalleolar surgical approach from 1974 to 2011, thirty-three were available for follow-up at ten to thirty-six years or had failed prior to that time. The indication for implantation had been osteonecrosis in twenty-three patients, a comminuted talar fracture in eight, and a talar body tumor in two. Twenty-eight of the thirty-three prostheses were still in place at the time of final follow-up and five had failed prior to five years. The duration of follow-up was ten to twenty years in eight patients, twenty to thirty years in eleven, and thirty to thirty-six years in nine. The AOFAS (American Orthopaedic Foot & Ankle Society) ankle-hindfoot score did not differ significantly among these three groups. Patients over sixty-five years of age with underlying disease that impeded walking ability had lower AOFAS scores. Early prosthesis failure occurred as a result of size mismatch in two patients, tumor recurrence in one, infection in one, and osteonecrosis of the talar head and neck in one. These failures, which occurred at eight to fifty-seven months, were treated with tibiotalar arthrodesis in three patients, prosthesis revision in one, and below-the-knee amputation in one. Although early prosthesis failure may occur, survival of the talar body prosthesis can provide satisfactory ankle and foot function. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2014 by The Journal of Bone and Joint Surgery, Incorporated.

  15. Search for relativistic magnetic monopoles with five years of the ANTARES detector data

    NARCIS (Netherlands)

    Albert, A.; André, M.; Anghinolfi, M.; Anton, G.; Ardid, M.; Aubert, J.-J.; Avgitas, T.; Baret, B.; Barrios-Martí, J.; Basa, S.; Bertin, V.; Biagi, S.; Bormuth, R.; Bourret, S.; Bouwhuis, M.C.; Bruijn, R.; Brunner, J.; Busto, J.; Capone, A.; Caramete, L.; Carr, J.; Celli, S.; Chiarusi, T.; Circella, M.; Coelho, J.A.; Coleiro, A.; Coniglione, R.; Costantini, H.; Coyle, P.; Creusot, A.; Deschamps, A.; De Bonis, G.; Distefano, C.; Di Palma, I.; Domi, A.; Donzaud, C.; Dornic, D.; Drouhin, D.; Eberl, T.; El Bojaddaini, I.; Elsässer, D.; Enzenhöfer, A.; Felis, I.; Fusco, L.A.; Galatà, S.; Gay, P.; Giordano, V.; Glotin, H.; Grégoire, T.; Gracia-Ruiz, R.; Graf, K.; Hallmann, S.; van Haren, H.; Heijboer, A.J.; Hello, Y.; Hernandez-Rey, J.J.; Hößl, J.; Hofestädt, J.; Hugon, C.; Illuminati, G.; James, C.W.; de Jong, M.; Jongen, M.; Kadler, M.; Kalekin, O.; Katz, U.; Kießling, D.; Kouchner, A.; Kreter, M.; Kreykenbohm, I.; Kulikovskiy, V.; Lachaud, C.; Lahmann, R.; Lefevre, D.; Leonora, E.; Lotze, M.; Loucatos, S.; Marcelin, M.; Margiotta, A.; Marinelli, A.; Martinez-Mora, J.A.; Mele, R.; Melis, K.; Michael, T.; Migliozzi, P.; Moussa, A.; Navas, S.; Nezri, E.; Organokov, M.; Pavalas, G.E.; Pellegrino, C.; Perrina, C.; Piattelli, P.; Popa, V.; Pradier, T.; Quinn, L.; Racca, C.; Riccobene, G.; Sánchez-Losa, A.; Saldaña, M.; Salvadori, I.; Samtleben, D.F.E.; Sanguineti, M.; Sapienza, P.; Schüssler, F.; Sieger, C.; Spurio, M.; Stolarczyk, Th.; Taiuti, M.; Tayalati, Y.; Trovato, A.; Turpin, D.; Tönnis, C.; Vallage, B.; Van Elewyck, V.; Versari, F.; Vivolo, D.; Vizzoca, A.; Wilms, J.; Zornoza, J.D.; Zúñiga, J.

    2017-01-01

    A search for magnetic monopoles using five years of data recorded with the ANTARES neutrino telescope from January 2008 to December 2012 with a total live time of 1121 days is presented. The analysis is carried out in the range β > 0.6 of magnetic monopole velocities using a strategy based on

  16. Preliminary ten year results from a randomised single centre mass screening trial for abdominal aortic aneurysm

    DEFF Research Database (Denmark)

    Lindholt, Jes Sanddal; Juul, Søren; Fasting, H

    2006-01-01

    At present, several regions and countries are considering screening for abdominal aortic aneurysm (AAA). However, The Chichester Aneurysms Screening Trial has reported poor long term benefit of screening for AAA. We therefore supplement previously published data with a preliminary analysis...

  17. [Epidemiologic behavior of malignant digestive tract tumors over a five year period in Veracruz, Mexico].

    Science.gov (United States)

    Roesch-Dietlen, F; Jiménez-García, V A; Remes-Troche, J M; Rubio-Arce, J F; López-Salinas, A; Ruiz-Juárez, I; Grube-Pagola, P; Silva-Cañetas, C F

    2012-01-01

    Tumors of the digestive system are considered to be a public health problem because of their elevated mortality rate. In Mexico, gastric cancer and colon cancer rank fourth and fifth, respectively, following tracheal, bronchial, and lung cancer, and there has been an increase in their frequency in the last few years. However, there are no specific studies that have evaluated their epidemiologic behavior in Veracruz. To determine the frequency of digestive system cancer in five health institutions in the city of Veracruz and to describe its epidemiologic behavior over a five-year period. Annual statistics from the following hospitals were reviewed: the Instituto Mexicano del Seguro Social, the Secretaría de Salud, the Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, Petróleos Mexicanos, and the Secretaría de la Defensa Nacional within the time frame of January 2005 to December 2009. Diagnoses based on histopathology were recorded, along with patient age and sex. A total of 1803 cases of digestive tract cancers were detected: 52% were men and 48% were women. A yearly increase in the number of cases was observed with colon cancer being in first place, followed by stomach cancer and rectal cancer. The increase in digestive system cancer cases over the last five years in Veracruz underlines the need to evaluate the implementation of screening programs for the at-risk population and to study the different etiologic factors involved in its manifestation.

  18. First-year results of the Global Influenza Hospital Surveillance Network: 2012–2013 Northern hemisphere influenza season

    Science.gov (United States)

    2014-01-01

    Background The Global Influenza Hospital Surveillance Network (GIHSN) was developed to improve understanding of severe influenza infection, as represented by hospitalized cases. The GIHSN is composed of coordinating sites, mainly affiliated with health authorities, each of which supervises and compiles data from one to seven hospitals. This report describes the distribution of influenza viruses A(H1N1), A(H3N2), B/Victoria, and B/Yamagata resulting in hospitalization during 2012–2013, the network’s first year. Methods In 2012–2013, the GIHSN included 21 hospitals (five in Spain, five in France, four in the Russian Federation, and seven in Turkey). All hospitals used a reference protocol and core questionnaire to collect data, and data were consolidated at five coordinating sites. Influenza infection was confirmed by reverse-transcription polymerase chain reaction. Hospitalized patients admitted within 7 days of onset of influenza-like illness were included in the analysis. Results Of 5034 patients included with polymerase chain reaction results, 1545 (30.7%) were positive for influenza. Influenza A(H1N1), A(H3N2), and both B lineages co-circulated, although distributions varied greatly between coordinating sites and over time. All age groups were affected. A(H1N1) was the most common influenza strain isolated among hospitalized adults 18–64 years of age at four of five coordinating sites, whereas A(H3N2) and B viruses were isolated more often than A(H1N1) in adults ≥65 years of age at all five coordinating sites. A total of 16 deaths and 20 intensive care unit admissions were recorded among patients with influenza. Conclusions Influenza strains resulting in hospitalization varied greatly between coordinating sites and over time. These first-year results of the GIHSN are relevant, useful, and timely. Due to its broad regional representativeness and sustainable framework, this growing network should contribute substantially to understanding the

  19. Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial.

    Science.gov (United States)

    Maruani, Annabel; Boutron, Isabelle; Baron, Gabriel; Ravaud, Philippe

    2014-09-19

    To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation, to remind them of the legal requirement to post results. Cohort embedded pragmatic randomized controlled trial. Trials registered on ClinicalTrials.gov. 190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention (personalized emails structured as a survey and sent by one of us to responsible parties of the trials, indirectly reminding them of the legal requirement and potential penalties for non-compliance). The primary outcome was the proportion of results posted on ClinicalTrials.gov at three months. The secondary outcome was the proportion posted at six months. In a second step, two assessors blinded to the intervention group collected the date of the first results being received on ClinicalTrials.gov. A post hoc sensitivity analysis excluding trials wrongly included was performed. Among 379 trials included, 190 were randomized to receive the email intervention. The rate of posting of results did not differ at three months between trials with or without the intervention: 36/190 (19%) v 24/189 (13%), respectively (relative risk 1.5, 95% confidence interval 0.9 to 2.4, P=0.096) but did at six months: 46/190 (24%) v 27/189 (14%), 1.7, 1.1 to 2.6, P=0.014. In the sensitivity analysis, which excluded 48/379 trials (13%), 26/190 (14%) and 22/189 (12%), respectively, results were significant at three months (relative risk 5.1, 1.1 to 22.9, P=0.02) and at six months (4.1, 1.3 to 10.6, P=0.001). Sending email reminders about the FDA's legal requirement to post results at ClinicalTrials.gov improved significantly the posting rate at six months but not at three months.Trial registration ClinicalTrials.gov NCT01658254. © Maruani et al 2014.

  20. Five-year activity (1981-1985) on the project ionizing and nonionizing radiation protection investigations

    International Nuclear Information System (INIS)

    Zaricj, M.

    1987-01-01

    The brief review of the work conducted during five year's period on the project is given. Some organization and financial questions are touched. In spite of the permanent difficulties, it may be concluded that past period was successful. (author) 3 refs

  1. Five years database of landslides and floods affecting Swiss transportation networks

    Science.gov (United States)

    Voumard, Jérémie; Derron, Marc-Henri; Jaboyedoff, Michel

    2017-04-01

    Switzerland is a country threatened by a lot of natural hazards. Many events occur in built environment, affecting infrastructures, buildings or transportation networks and producing occasionally expensive damages. This is the reason why large landslides are generally well studied and monitored in Switzerland to reduce the financial and human risks. However, we have noticed a lack of data on small events which have impacted roads and railways these last years. This is why we have collect all the reported natural hazard events which have affected the Swiss transportation networks since 2012 in a database. More than 800 roads and railways closures have been recorded in five years from 2012 to 2016. These event are classified into six classes: earth flow, debris flow, rockfall, flood, avalanche and others. Data come from Swiss online press articles sorted by Google Alerts. The search is based on more than thirty keywords, in three languages (Italian, French, German). After verifying that the article relates indeed an event which has affected a road or a railways track, it is studied in details. We get finally information on about sixty attributes by event about event date, event type, event localisation, meteorological conditions as well as impacts and damages on the track and human damages. From this database, many trends over the five years of data collection can be outlined: in particular, the spatial and temporal distributions of the events, as well as their consequences in term of traffic (closure duration, deviation, etc.). Even if the database is imperfect (by the way it was built and because of the short time period considered), it highlights the not negligible impact of small natural hazard events on roads and railways in Switzerland at a national level. This database helps to better understand and quantify this events, to better integrate them in risk assessment.

  2. Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures: Vital D study.

    Science.gov (United States)

    Sanders, Kerrie M; Stuart, Amanda L; Merriman, Elizabeth N; Read, Meaghan L; Kotowicz, Mark A; Young, Doris; Taylor, Roderick; Blair-Holt, Ian; Mander, Alistair G; Nicholson, Geoffrey C

    2009-11-25

    Randomised, placebo-controlled trials are needed to provide evidence demonstrating safe, effective interventions that reduce falls and fractures in the elderly. The quality of a clinical trial is dependent on successful recruitment of the target participant group. This paper documents the successes and failures of recruiting over 2,000 women aged at least 70 years and at higher risk of falls or fractures onto a placebo-controlled trial of six years duration. The characteristics of study participants at baseline are also described for this study. The Vital D Study recruited older women identified at high risk of fracture through the use of an eligibility algorithm, adapted from identified risk factors for hip fracture. Participants were randomised to orally receive either 500,000 IU vitamin D3 (cholecalciferol) or placebo every autumn for five consecutive years. A variety of recruitment strategies were employed to attract potential participants. Of the 2,317 participants randomised onto the study, 74% (n = 1716/2317) were consented onto the study in the last five months of recruiting. This was largely due to the success of a targeted mail-out. Prior to this only 541 women were consented in the 18 months of recruiting. A total of 70% of all participants were recruited as a result of targeted mail-out. The response rate from the letters increased from 2 to 7% following revision of the material by a public relations company. Participant demographic or risk factor profile did not differ between those recruited by targeted mail-outs compared with other methods. The most successful recruitment strategy was the targeted mail-out and the response rate was no higher in the local region where the study had extensive exposure through other recruiting strategies. The strategies that were labour-intensive and did not result in successful recruitment include the activities directed towards the GP medical centres. Comprehensive recruitment programs employ overlapping strategies

  3. Maintained benefits and improved survival of dynamic cardiomyoplasty by activity-rest stimulation: 5-year results of the Italian trial on "demand" dynamic cardiomyoplasty.

    Science.gov (United States)

    Rigatelli, Gianluca; Barbiero, Mario; Rigatelli, Giorgio; Riccardi, Roberto; Cobelli, Franco; Cotogni, Angelo; Bandello, Attilio; Carraro, Ugo

    2003-01-01

    Latissimus dorsi (LD) muscular degeneration caused by continuous electrical stimulation has been the main cause of the poor results of dynamic cardiomyoplasty (DCMP) and its exclusion from the recent international guidelines on heart failure. To avoid full transformation of the LD and to improve results, a new stimulation protocol was developed; fewer impulses per day are delivered, providing the LD wrap with daily periods of rest ("demand" stimulation), based on a heart rate cut-off. The aim of this work is to report the results at 5 years of follow-up of the Italian Trial of Demand Dynamic Cardiomyoplasty and to discuss their impact on the destiny of this type of cardiac assistance. Twelve patients with dilated myocardiopathy (M/F=11/1, mean age 58.2+/-5.8 years, sinus rhythm/atrial fibrillation=11/1) were submitted during the period 1993-1996 to DCMP and at different intervals to demand protocol. Clinical, echocardiographic, mechanographic and cardiac invasive assessments were scheduled before initiating the demand protocol and during the follow-up at 0, 6 and every 12 months. The mean duration of follow-up was 40.2+/-13.8 months (range 18-64). There were no perioperative deaths. The demand stimulation protocol showed a decrease in 5 years in New York Health Association (NYHA) class (3.17+/-0.38-1.67+/-0.77, P=0.0001), an improvement of left ventricular ejection fraction (22.6+/-4.38-32.0+/-7.0, Pactuarial survival of 83.3% (one patient was switched to heart transplantation programme due to clinical worsening and another one died of massive pulmonary embolism). Demand DCMP maintains over time LD muscular properties, enhances clinical benefits and improves survival of DCMP, thus reopening the debate whether this type of treatment should be considered in patients with end-stage heart failure.

  4. Green Tea as an Agricultural Based Health Promoting Food: The Past Five to Ten Years

    Directory of Open Access Journals (Sweden)

    Qin-Yin Shi

    2012-12-01

    Full Text Available The consumption of tea originated in ancient China over 4000 years ago and is currently the second most popular beverage in the world after water. Tea is an aromatic beverage prepared by pouring hot water over cured leaves of the Camellia sinensis plant. The link between tea intake, most notably green tea, and health has resulted in intense research on the components responsible for preventing the onset of several chronic diseases, including atherosclerosis, cancer, obesity and diabetes. In particular, the high levels of chemically diverse phenols (e.g., phenolic acids, flavonoids present in tea exhibit potent protective properties against many of these diseases. Although health related research on green tea and its predominant phenol (catechins has been on-going for decades, major advances have occurred in the last 5–10 years. Therefore, this review focuses on seminal studies reported primarily within the last five years but not extending past ten years on the link between health and green tea with an emphasis on the catechins.

  5. Financial management of a large multisite randomized clinical trial.

    Science.gov (United States)

    Sheffet, Alice J; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E; Longbottom, Mary E; Howard, Virginia J; Marler, John R; Brott, Thomas G

    2014-08-01

    The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years' funding ($21 112 866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2500 randomized participants at 40 sites. Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Projections of the original grant's fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant's fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2500 targeted sample size, 138 (5·5%) were randomized during the first five years and 1387 (55·5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13 845) of the projected per-patient costs ($152 992) of the fixed model. Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. © 2014 The Authors. International Journal of Stroke © 2014 World Stroke Organization.

  6. Five-year follow-up of low-level laser therapy (LLLT) in patients with age-related macular degeneration (AMD)

    Science.gov (United States)

    Koev, K.; Avramov, L.; Borissova, E.

    2018-03-01

    The objective of this study was to examine long-term effects of low-level laser therapy (LLLT) in patients with age-related macular degeneration (AMD). The research was implemented for a period of five years. For LLLT, a He-Ne Laser with continuous emission at 633 nm (0.1 mW/cm2) was used in patients with AMD of all stages (dry to wet exudative forms were included). In total, 33 patients (16 men and 17 women – 66 eyes) with AMD of various stages and a mean age of 68.7 ± 4.2 years were included in the study. Progressive, exudative AMD was diagnosed in 8 eyes. 58 eyes had drusen or were depigmented. Laser radiation was applied transpupillary to the macula for six times for three minutes once in two days; 22 patients with AMD (44 eyes) were randomly selected to receive mock treatment (control group 10 men and 12 women with a mean age of 69.3 ± 4.8 years). The visual acuity was followed for a five-year period. The perimetry and Amsler test were used to screen central scotomas. The fluorescein angiography of AMD and the control groups was examined. The visual acuity remained unchanged in all patients in the control group. There was a statistically significant increase in the visual acuity (p<0.001, end of study versus baseline) for AMD patients for the period of five years after the treatment. The edema and hemorrhage in the patients with progressive, exudative AMD significantly decreased. No side effects were observed during the therapy. The prevalence of metamorphopsia, scotoma in AMD group was reduced. In conclusion, this study shows that LLLT may be a novel long-lasting therapeutic option for both forms of AMD. It is a highly-effective treatment that results in a long-term improvement of the visual acuity.

  7. Postoperative Complications in the Ahmed Baerveldt Comparison Study during Five Years of Follow-up

    Science.gov (United States)

    Budenz, Donald L.; Feuer, William J.; Barton, Keith; Schiffman, Joyce; Costa, Vital P.; Godfrey, David G.; Buys, Yvonne M.

    2016-01-01

    PURPOSE To compare the late complications in the Ahmed Baerveldt Comparison Study during 5 years of follow-up. DESIGN Multicenter, prospective, randomized clinical trial. METHODS SETTINGS Sixteen international clinical centers. STUDY POPULATION Two hundred seventy six subjects aged 18 to 85 years with previous intraocular surgery or refractory glaucoma with intraocular pressure of > 18 mmHg. INTERVENTIONS Ahmed Glaucoma Valve FP7 or Baerveldt Glaucoma Implant BG 101-350. MAIN OUTCOME MEASURES Late postoperative complications (beyond 3 months), reoperations for complications, and decreased vision from complications. RESULTS Late complications developed in 56 subjects (46.8 ± 4.8 5 year cumulative % ± SE) in the Ahmed Glaucoma Valve group and 67 (56.3 ± 4.7 5 year cumulative % ± SE) in the Baerveldt Glaucoma Implant group (P = 0.082). The cumulative rates of serious complications were 15.9% and 24.7% in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups respectively (P = 0.034) although this was largely driven by subjects who had tube occlusions in the two groups (0.8% in the Ahmed Glaucoma Valve group and 5.7% in the Baerveldt Glaucoma Implant group, P = 0.037). Both groups had a relatively high incidence of persistent diplopia (12%) and corneal edema (20%), although half of the corneal edema cases were likely due to pre-existing causes other than the aqueous shunt. The incidence of tube erosion was 1% and 3% in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups, respectively (P = 0.04). CONCLUSIONS Long term rates of vision threatening complications and complications resulting in reoperation were higher in the Baerveldt Glaucoma Implant than the Ahmed Glaucoma Valve group over 5 years of follow-up. PMID:26596400

  8. Assessment of a five-year survival on hemodialysis in Brazil: a cohort of 3,082 incident patients

    Directory of Open Access Journals (Sweden)

    Jorge Paulo Strogoff de Matos

    2011-12-01

    Full Text Available Brazil has the third largest contingent of patients on maintenance hemodialysis (HD worldwide. However, little is known regarding survival rate and predictors of mortality risk in that population, which are the purposes of this study. A total of 3,082 patients incident on HD, from 2000 to 2004, at 25 dialysis facilities distributed among 7 out of 26 states of Brazil were followed-up until 2009. Patients were 52 ± 16 years-old, 57.8% men, and 20.4%, diabetics. The primary outcome was all causes of mortality. Data were censored at five years of follow-up. The global five-year survival rate was 58.2%. In the Cox proportional model, variables associated with risk of death were: age (hazard ratio - HR = 1.44 per decade, p < 0.0001, diabetes (HR = 1.51, p < 0.0001, serum albumin (HR = 0.76 per g/dL, p = 0.001, creatinine (HR = 0.92 per mg/dL, p < 0.0001, and phosphorus (HR = 1.06 per mg/dL, p = 0.04. The present results show that the mortality rate on HD in this Brazilian cohort was relatively low, but the population is younger and with a lower prevalence of diabetes than the ones reported for developed countries.

  9. Five-Kilometers Time Trial: Preliminary Validation of a Short Test for Cycling Performance Evaluation.

    Science.gov (United States)

    Dantas, Jose Luiz; Pereira, Gleber; Nakamura, Fabio Yuzo

    2015-09-01

    The five-kilometer time trial (TT5km) has been used to assess aerobic endurance performance without further investigation of its validity. This study aimed to perform a preliminary validation of the TT5km to rank well-trained cyclists based on aerobic endurance fitness and assess changes of the aerobic endurance performance. After the incremental test, 20 cyclists (age = 31.3 ± 7.9 years; body mass index = 22.7 ± 1.5 kg/m(2); maximal aerobic power = 360.5 ± 49.5 W) performed the TT5km twice, collecting performance (time to complete, absolute and relative power output, average speed) and physiological responses (heart rate and electromyography activity). The validation criteria were pacing strategy, absolute and relative reliability, validity, and sensitivity. Sensitivity index was obtained from the ratio between the smallest worthwhile change and typical error. The TT5km showed high absolute (coefficient of variation 0.95) reliability of performance variables, whereas it presented low reliability of physiological responses. The TT5km performance variables were highly correlated with the aerobic endurance indices obtained from incremental test (r > 0.70). These variables showed adequate sensitivity index (> 1). TT5km is a valid test to rank the aerobic endurance fitness of well-trained cyclists and to differentiate changes on aerobic endurance performance. Coaches can detect performance changes through either absolute (± 17.7 W) or relative power output (± 0.3 W.kg(-1)), the time to complete the test (± 13.4 s) and the average speed (± 1.0 km.h(-1)). Furthermore, TT5km performance can also be used to rank the athletes according to their aerobic endurance fitness.

  10. Ranking of patient and surgeons' perspectives for endpoints in randomized controlled trials--lessons learned from the POVATI trial [ISRCTN 60734227].

    Science.gov (United States)

    Fischer, Lars; Deckert, Andreas; Diener, Markus K; Zimmermann, Johannes B; Büchler, Markus W; Seiler, Christoph M

    2011-10-01

    Surgical trials focus mainly on mortality and morbidity rates, which may be not the most important endpoints from the patient's perspective. Evaluation of expectations and needs of patients enrolled in clinical trials can be analyzed using a procedure called ranking. Within the Postsurgical Pain Outcome of Vertical and Transverse Abdominal Incision randomized trial (POVATI), the perspectives of participating patients and surgeons were assessed as well as the influence of the surgical intervention on patients' needs. All included patients of the POVATI trial were asked preoperatively and postoperatively to rank predetermined outcome variables concerning the upcoming surgical procedure (e.g., pain, complication, cosmetic result) hierarchically according to their importance. Preoperatively, the surgeons were asked to do the same. One hundred eighty two out of 200 randomized patients (71 females, 111 males; mean age 59 years) returned the ranking questionnaire preoperatively and 152 patients (67 females, 85 males; mean age 60 years) on the day of discharge. There were no differences between the two groups with respect to the distribution of ranking variables (p > 0.05). Thirty-five surgeons (7 residents, 6 fellows, and 22 consultants) completed the same ranking questionnaire. The order of the four most important ranking variables for both patients and surgeons were death, avoiding of postoperative complications, avoiding of intraoperative complications, and pain. Surgeons ranked the variable "cosmetic result" significantly as more important compared to patients (p = 0.034, Fisher's exact test). Patients and surgeons did not differ in ranking predetermined outcomes in the POVATI trial. Only the variable "cosmetic result" is significantly more important from the surgeon's than from the patient's perspective. Ranking of outcomes might be a beneficial tool and can be a proper addition to RCTs.

  11. The 2-Year Cosmetic Outcome of a Randomized Trial Comparing Prone and Supine Whole-Breast Irradiation in Large-Breasted Women

    Energy Technology Data Exchange (ETDEWEB)

    Veldeman, Liv, E-mail: liv.veldeman@uzgent.be [Department of Radiation Oncology, University Hospital Ghent, Ghent (Belgium); Department of Radiotherapy and Experimental Cancer Research, Ghent University, Ghent (Belgium); Schiettecatte, Kimberly; De Sutter, Charlotte; Monten, Christel; Greveling, Annick van [Department of Radiation Oncology, University Hospital Ghent, Ghent (Belgium); Berkovic, Patrick [Department of Radiation Oncology, University Hospital Ghent, Ghent (Belgium); Department of Radiation Oncology, Centre Hospitalier Universitaire de Liège, Liège (Belgium); Mulliez, Thomas [Department of Radiation Oncology, University Hospital Ghent, Ghent (Belgium); De Neve, Wilfried [Department of Radiation Oncology, University Hospital Ghent, Ghent (Belgium); Department of Radiotherapy and Experimental Cancer Research, Ghent University, Ghent (Belgium)

    2016-07-15

    Purpose: To report the 2-year cosmetic outcome of a randomized trial comparing prone and supine whole-breast irradiation in large-breasted patients. Methods and Materials: One hundred patients with a (European) cup size ≥C were included. Before and 2 years after radiation therapy, clinical endpoints were scored and digital photographs were taken with the arms alongside the body and with the arms elevated 180°. Three observers rated the photographs using the 4-point Harvard cosmesis scale. Cosmesis was also evaluated with the commercially available Breast Cancer Conservation Treatment.cosmetic results (BCCT.core) software. Results: Two-year follow-up data and photographs were available for 94 patients (47 supine treated and 47 prone treated). Patient and treatment characteristics were not significantly different between the 2 cohorts. A worsening of color change occurred more frequently in the supine than in the prone cohort (19/46 vs 10/46 patients, respectively, P=.04). Five patients in the prone group (11%) and 12 patients in the supine group (26%) presented with a worse scoring of edema at 2-year follow-up (P=.06). For retraction and fibrosis, no significant differences were found between the 2 cohorts, although scores were generally worse in the supine cohort. The cosmetic scoring by 3 observers did not reveal differences between the prone and supine groups. On the photographs with the hands up, 7 patients in the supine group versus none in the prone group had a worsening of cosmesis of 2 categories using the (BCCT.org) software (P=.02). Conclusion: With a limited follow-up of 2 years, better cosmetic outcome was observed in prone-treated than in supine-treated patients.

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

    DEFF Research Database (Denmark)

    Lynge, Elsebeth; Rebolj, Matejka

    2009-01-01

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

  13. Updated results of a pilot study of low dose craniospinal irradiation plus chemotherapy for children under five with cerebellar primitive neuroectodermal tumors (medulloblastoma)

    International Nuclear Information System (INIS)

    Goldwein, Joel W.; Radcliffe, Jerilynn; Johnson, James; Moshang, Thomas; Packer, Roger J.; Sutton, Leslie N.; Rorke, Lucy B.; D'Angio, Giulio J.

    1996-01-01

    Purpose: Children under 5 years old with medulloblastoma (MB) have a poor prognosis. They are more susceptible to the deleterious effects of craniospinal irradiation (CSART) and have a higher relapse rate when treated with low-dose CSART alone. We, thus, embarked on a prospective trial testing the usefulness of very low dose CSART and adjuvant chemotherapy. This is an update of a previous report on these patients. Methods and Materials: Between January 1988 and March 1990, 10 patients with medulloblastoma were treated using 18 Gy radiation therapy (RT) to the craniospinal axis, a posterior fossa (PF) boost to 50.4-55.8 Gy and chemotherapy consisting of vincristine (VCR) weekly during RT. This was followed by VCR, cis-diamminedichloroplatinum (CDDP), and lomustine (CCNU) for eight, 6-week cycles. Patients between 18 and 60 months of age without evidence of tumor dissemination were eligible for study. Follow-up was available until September 1994 with a median follow-up for living patients of 6.3 years from diagnosis. Results: Actuarial survival at over 6 years is 70 ± 20%. Three of the 10 patients relapsed and died. In one patient, the relapse developed in the spine and brain outside the posterior fossa, in the second, concurrently in the posterior fossa, brain and spine, and the third, only in the spine. One surviving child developed a brain stem infarct 4.8 years after diagnosis and has since almost fully recovered. A mean intelligence quotient (IQ) score of 103 in six patients surviving at least 1 year is unchanged from the baseline group score of 107. Five children tested at baseline and 2 years following treatment had IQ scores of 101 and 102, respectively. Six children tested at baseline and at 3 years had IQ scores of 106 and 96, respectively. Excluding the child tested shortly after his brain stem infarct, baseline and 3 year IQ scores were 103 and 97, respectively. Five of the seven long-term survivors grew at rates significantly below their expected

  14. ANALYSIS ON THE EVOLUTION OF INSURANCE SYSTEMS IN ROMANIA - THE PAST FIVE YEARS

    Directory of Open Access Journals (Sweden)

    AURELIA PĂTRAȘCU

    2016-08-01

    Full Text Available The aim of this paper is to analyze the evolution of insurance systems in Romania in the past five years. Unlike other European countries, it can be seen that Romania does not have a well-established insurance tradition. Insurance companies are constantly adapting to the realities of the financial situation and the market structure in Romania.

  15. An Explanation on the Tenth-Five-Year Plan of China’s Auto Industry

    Institute of Scientific and Technical Information of China (English)

    2002-01-01

    <正> The Tenth-Five-Year-Plan of the auto industry recently issued has made an analysis on the market demand, development environment and situation that the auto industry will face and advanced the idea for solving contractions and problems, taking the restructuring as motif. Compared with the previous medium-and-long-term programs, the plan is more macroscopic, strategical,

  16. Revisiting restored river reaches - Assessing change of aquatic and riparian communities after five years.

    Science.gov (United States)

    Lorenz, Armin W; Haase, Peter; Januschke, Kathrin; Sundermann, Andrea; Hering, Daniel

    2018-02-01

    Hydromorphological restructuring of river sections, i.e. river restoration measures, often has little effects on aquatic biota, even in case of strong habitat alterations. It is often supposed that the biotic response is simply delayed as species require additional time to recolonize the newly generated habitats and to establish populations. To identify and specify the supposed lag time between restoration and biotic response, we investigated 19 restored river reaches twice in a five-year interval. The sites were restored one to ten years prior to the first sampling. We sampled three aquatic (fish, benthic invertebrates, macrophytes) and two riparian organism groups (ground beetles and riparian vegetation) and analyzed changes in assemblage composition and biotic metrics. With the exception of ground beetle assemblages, we observed no significant changes in richness and abundance metrics or metrics used for biological assessment. However, indicator taxa for near-natural habitat conditions in the riparian zone (indicators for regular inundation in plants and river bank specialists in beetles) improved significantly in the five-year interval. Contrary to general expectations in river restoration planning, we neither observed a distinct succession of aquatic communities nor a general trend towards "good ecological status" over time. Furthermore, multiple linear regression models revealed that neither the time since restoration nor the morphological status had a significant effect on the biological metrics and the assessment results. Thus, the stability of aquatic assemblages is strong, slowing down restoration effects in the aquatic zone, while riparian assemblages improve more rapidly. When defining restoration targets, the different timelines for ecological recovery after restoration should be taken into account. Furthermore, restoration measures should not solely focus on local habitat conditions but also target stressors acting on larger spatial scales and take

  17. Lower urinary tract symptoms after subtotal versus total abdominal hysterectomy: exploratory analyses from a randomized clinical trial with a 14-year follow-up.

    Science.gov (United States)

    Andersen, Lea Laird; Møller, Lars Mikael Alling; Gimbel, Helga

    2015-12-01

    Lower urinary tract symptoms (LUTS) are common after hysterectomy and increase after menopause. We aimed to compare subtotal with total abdominal hysterectomy regarding LUTS, including urinary incontinence (UI) subtypes, 14 years after hysterectomy. Main results from this randomized clinical trial have been published previously; the analyses covered in this paper are exploratory. We performed a long-term questionnaire follow-up of women in a randomized clinical trial (n = 319), from 1996 to 2000 comparing subtotal with total abdominal hysterectomy. Of the randomized women, ten had died and five had left Denmark; 304 women were contacted. For univariate analyses, a χ(2)-test was used, and for multivariate analyses, we used logistic regression. The questionnaire was answered by 197 (64.7 %) women (subtotal 97; total 100). More women had subjective stress UI (SUI) in the subtotal group (n = 60; 62.5 %) compared with the total group (n = 45; 45 %), with a relative risk (RR) of 1.39 [95 % confidence interval (CI) 1.06-1.81; P = 0.014]. No difference was seen between subtotal and total abdominal hysterectomy in other LUTS. Factors associated with UI were UI prior to hysterectomy, local estrogen treatment, and body mass index (BMI) > 25 kg/m(2). High BMI was primarily associated with mixed UI (MUI) and urgency symptoms. Predictors of bothersome LUTS were UI and incomplete bladder emptying. The difference in the frequency of subjectively assessed UI between subtotal and total abdominal hysterectomy (published previously) is caused by a difference in subjectively assessed SUI; UI prior to hysterectomy and high BMI are related to UI 14 years after hysterectomy. The trial is registered on clinicaltrials.gov under Nykoebing Falster County Hospital Record sj-268: Total versus subtotal hysterectomy: http://clinicaltrials.gov/ct2/show/NCT01880710?term=hysterectomy&rank=27.

  18. Outcome of Treatment of Uveitic Macular Edema: The Multicenter Uveitis Steroid Treatment Trial 2-Year Results.

    Science.gov (United States)

    Tomkins-Netzer, Oren; Lightman, Susan; Drye, Lea; Kempen, John; Holland, Gary N; Rao, Narsing A; Stawell, Richard J; Vitale, Albert; Jabs, Douglas A

    2015-11-01

    To evaluate the 2-year outcomes of uveitic macular edema. Longitudinal follow-up of a randomized cohort. At baseline, 148 eyes of 117 patients enrolled in the Multicenter Uveitis Steroid Treatment (MUST) Trial had macular edema, and 134 eyes of 108 patients completed 2-year follow-up. Patients enrolled in the study were randomized to either systemic immunosuppression or intravitreal fluocinolone acetonide implant therapy. Macular edema was defined as thickening of the retina (center point thickness≥240 μm) on time-domain optical coherence tomography (OCT) of macula. Improvement in macular edema (≥20% reduction in central point thickness on OCT), resolution of macular edema (normalization of thickness on OCT), and best-corrected visual acuity (BCVA). Between randomization and 2-years' follow-up, 62% and 25% of eyes in the systemic and implant groups, respectively, received at least 1 supplemental regional corticosteroid injection. By 2-years' follow-up, macular edema improved in 71% of eyes and resolved in 60%. There were no differences between treatment groups in the proportion of eyes with macular edema improving (systemic therapy vs. implant, 65% vs. 77%; P=0.20) and resolving (52% vs. 68%; P=0.28), but eyes randomized to implant had more improvement in macular thickness (median decrease of 180 vs. 109 μm in the systemic therapy group; P=0.04). Eyes with baseline fluorescein angiographic leakage were more likely to improve than those without (76% vs. 58%; P=0.03). Overall, there was a mean 5-letter (1 line) improvement in BCVA at 2 years. Mean changes in BCVA from baseline at 2 years by macular edema response status were: resolution, +10 letters; improvement without resolution, +10 letters (P=0.92); little to no change, 6 letters (P=0.19); and worsening, -16 letters (worsening acuity; P=0.0003). About two thirds of eyes with uveitic macular edema were observed to experience improvement in the edema and visual acuity with implant or systemic treatment

  19. Acceptance of family planning methods by induced abortion seekers: An observational study over five years.

    Science.gov (United States)

    Kathpalia, S K

    2016-01-01

    Prior to legalization of abortion, induced abortions were performed in an illegal manner and that resulted in many complications hence abortion was legalized in India in 1971 and the number of induced abortions has been gradually increasing since then. One way of preventing abortions is to provide family planning services to these abortion seekers so that same is not repeated. The study was performed to find out the acceptance of contraception after abortion. A prospective study was performed over a period of five years from 2010 to 2014. The study group included all the cases reporting for abortion. A proforma was filled in detail to find out the type of contraception being used before pregnancy and acceptance of contraception after abortion. The existing facilities were also evaluated. 1228 abortions were performed over a period of five years. 94.5% of abortions were during the first trimester. 39.9% had not used any contraceptive before, contraceptives used were natural and barrier which had high failure. The main indication for seeking abortion was failure of contraception and completion of family. 39.6% of patients accepted sterilization as a method of contraception. The existing post abortion family planning services are inadequate. Post abortion period is one which is important to prevent subsequent abortions and family planning services after abortion need to be strengthened.

  20. Fat-Free Mass and Skeletal Muscle Mass Five Years After Bariatric Surgery.

    Science.gov (United States)

    Davidson, Lance E; Yu, Wen; Goodpaster, Bret H; DeLany, James P; Widen, Elizabeth; Lemos, Thaisa; Strain, Gladys W; Pomp, Alfons; Courcoulas, Anita P; Lin, Susan; Janumala, Isaiah; Thornton, John C; Gallagher, Dympna

    2018-07-01

    This study investigated changes in fat-free mass (FFM) and skeletal muscle 5 years after surgery in participants from the Longitudinal Assessment of Bariatric Surgery-2 trial. A three-compartment model assessed FFM, and whole-body magnetic resonance imaging (MRI) quantified skeletal muscle mass prior to surgery (T0) and 1 year (T1), 2 years (T2), and 5 years (T5) postoperatively in 93 patients (85% female; 68% Caucasian; age 44.2 ± 11.6 years) who underwent gastric bypass (RYGB), sleeve gastrectomy, or adjustable gastric band. Repeated-measures mixed models were used to analyze the data. Significant weight loss occurred across all surgical groups in females from T0 to T1. FFM loss from T0 to T1 was greater after RYGB (mean ± SE: -6.9 ± 0.6 kg) than adjustable gastric band (-3.5 ± 1.4 kg; P FFM (-3.3 ± 0.7 kg; P FFM loss while maintaining FFM and skeletal muscle from T1 to T5. Between 1 and 5 years following common bariatric procedures, FFM and skeletal muscle are maintained or decrease minimally. The changes observed in FFM and muscle during the follow-up phase may be consistent with aging. © 2018 The Obesity Society.

  1. RECURRENCE RATE OF HELICOBACTER PYLORI IN PATIENTS WITH PEPTIC ULCER FIVE YEARS OR MORE AFTER SUCCESSFUL ERADICATION.

    Science.gov (United States)

    Fernandes, Yuri Costa Farago; Bonatto, Gabriel da Rocha; Bonatto, Mauro Willeman

    2016-01-01

    Infection with Helicobacter pylori is highly prevalent worldwide, especially in developing countries. Its presence in the gastroduodenal mucosa is related with development of peptic ulcer and other illnesses. The eradication of H. pylori improves mucosal histology in patients with peptic ulcers. This study was aimed to verify if H. pylori recurrence occurs five years or more after confirmed eradication in patients with peptic ulcer. Moreover, we sought to determine the recurrence rate. Retrospective and longitudinal, this study was based on a sample of 201 patients from western Paraná, Brazil. The patients were diagnosed with peptic ulcer disease, in the period of 1990-2000, and followed for five years or more after successful H. pylori eradication. Patients with early recurrence - prior to five years after eradication - were excluded from the sample. During an average follow-up of 8 years, 180 patients (89.55%) remained negative, and 21 (10.45%) became positive for H. pylori infection. New ulcers appeared in two-thirds of the patients with H. pylori recurrence. The recurrence of H. pylori in patients with peptic ulcer can occur in the long-term - even if the infection had been successfully eradicated and the patients had remained free of recurrence in the first years of follow-up.

  2. The INNOVATION Trial: four-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System for endovascular repair.

    Science.gov (United States)

    Pratesi, Giovanni; Pratesi, Carlo; Chiesa, Roberto; Coppi, Gioacchino; Scheinert, Dierk; Brunkwall, Jan S; van der Meulen, Stefaan; Torsello, Giovanni

    2017-10-01

    This paper reports the 4-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System (Cordis Corp., Milpitas, CA, USA), an ultra-low-profile device for the treatment of abdominal aortic aneurysms. The INNOVATION Trial is the prospective, first-in-human, multicenter trial to evaluate the safety and effectiveness of the INCRAFT® System. Patients underwent annual clinical and computed tomography angiography examination as part of the study protocol. The INCRAFT® AAA Stent-Graft System is a customizable tri-modular design, with an ultra-low profile (14-Fr) delivery system. Patient were treated under approved protocol, the prescribed clinical and imaging follow-up at annually through 5 years. Results analyzed and adjudicated by a clinical events committee, independent core laboratory, and a data safety and monitoring board. This manuscript reports results through 4 years of follow-up. A total of 60 patients were enrolled in the trial, all of whom were successfully treated. Follow-up rates at 1 and 4 years were 93% (56/60) and 85% (51/60), respectively. All-cause mortality at 4 years was 17.6% and no death was AAA-, device-, or procedure-related. The secondary reintervention rate at 1 year was 4.6%, primarily the result of stent thrombosis. In total, 10 patients required 13 post-procedure interventions within 4-years of follow-up (2 to repair a type I endoleak, 4 to repair a type II endoleak, 1 for stent thrombosis, 1 for renal stenosis, 1 for aneurysm enlargement, 2 for limb migration and 2 for prosthesis stenosis or occlusion). There were 4 cases (10%) of aneurysm enlargement reported at the 4 year follow-up. At 4 years, 38 out of 39 patients were free from type I and III endoleaks. There were no proximal type I or type III endoleaks at 4-year follow-up. Core laboratory evaluation of the postoperative imaging studies indicated absence of endograft migration while a single fracture was demonstrated without any clinical sequelae. The INCRAFT® AAA Stent

  3. Five Year Retrospective Study of the Financial Situation of Northern Foods Plc., United Kingdom

    Directory of Open Access Journals (Sweden)

    Louie DACOSTA

    2016-09-01

    Full Text Available This study was conducted as a retrospective analysis of Northern Foods Plc., once a major player in FTSE 350 Food Sector, to evaluate its financial situation over a five year period. The ex post factor research design was used for this study. Annual reports and databases on Northern Foods Plc., and Associated British Foods Plc., were used to perform a series of ratio analyses. The results revealed that Northern Foods Plc.’s performance has been declining as evidenced in the profitability ratios calculated. Also, financial strength was weak and working capital has not been effectively managed, hence affecting its cash and profit generation potentials. The company was limited in its ability to grow and expand as it needed to regularly fund its pension deficit, and finance its high levels of debt. The study concludes that Northern Foods was not in a very strong financial position, yet it was not making the required investments to improve, hence its takeover though this paper will not rule out non-financial issues. Furthermore, the study prescribed five generic points to improve the financial health of any organisation.

  4. The SINS trial: A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma

    Directory of Open Access Journals (Sweden)

    Armstrong Sarah J

    2010-04-01

    Full Text Available Abstract Background Basal cell carcinoma is the commonest human cancer. Despite increasing incidence it remains poorly researched. While not life threatening it can cause significant cosmetic disfigurement. Imiquimod, a cream which enhances the body's immune response, may help deal with the number of cases that occur in low-risk sites, especially when good cosmetic results and home use without surgery are needed. This study aims 1. To compare excisional surgery with imiquimod cream for nodular or superficial basal cell carcinoma in low risk sites, with respect to 3 year clinical clearance, cost-effectiveness and cosmetic results. 2. To ascertain if certain phenotypic features and gene polymorphisms predict tumour responsiveness to treatment. Methods/Design Five hundred participants with low risk nodular or superficial basal cell carcinoma will be recruited from hospitals to this multi-centre, randomised, parallel group, controlled phase III trial. Treatment in the imiquimod group is for 6 weeks for superficial basal cell carcinoma and 12 weeks for nodular basal cell carcinoma. Both treatment groups are followed up in clinic for 3 years. Primary outcome variable: the proportion of participants with clinical evidence of success (no recurrence at 3 years. The primary outcome will be compared between the two treatment groups. Secondary outcomes include: i clinical success at 1, 2 and 5 years, ii time to first recurrence, iii cosmetic appearance of lesion site after treatment, iv level of pain, and v cost-effectiveness. Safety and tolerability data will also be reported. Discussion This study protocol describes a pragmatic randomised controlled trial which it is hoped will address the above uncertainties. Three-year results will be available towards the end of 2010. Trial registration Meta-register: NCT00066872, Eudract No. 2004-004506-24, ISRCTN48755084.

  5. Perceived weight status may contribute to education inequalities in five-year weight change among mid-aged women.

    Science.gov (United States)

    Siu, Jessica; Giskes, Katrina; Shaw, Jonathan; Turrell, Gavin

    2011-06-01

    To examine education differences in five-year weight change among mid-aged adults, and to ascertain if this may be due to socioeconomic differences in perceived weight status or weight control behaviours (WCBs). Data were used from the Australian Diabetes, Obesity and Lifestyle Study. Mid-aged men and women with measured weights at both baseline (1999-2000) and follow-up (2004-2005) were included. Percent weight change over the five-year interval was calculated and perceived weight status, WCBs and highest attained education were collected at baseline. Low-educated men and women were more likely to be obese at baseline compared to their high-educated counterparts. Women with a certificate-level education had a greater five-year weight gain than those with a bachelor degree or higher. Perceived weight status or WCBs did not differ by education among men and women, however participants that perceived themselves as very overweight had less weight gain than those perceiving themselves as underweight or normal weight. WCBs were not associated with five-year weight change. The higher prevalence of overweight/obesity among low-educated women may be a consequence of greater weight gain in mid-adulthood. Education inequalities in overweight/obesity among men and women made be due (in part) to overweight or obese individuals in low-educated groups not perceiving themselves as having a weight problem. © 2011 The Authors. ANZJPH © 2011 Public Health Association of Australia.

  6. Fifteen-Year Radiotherapy Outcomes of the Randomized PORTEC-1 Trial for Endometrial Carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Creutzberg, Carien L., E-mail: c.l.creutzberg@lumc.nl [Department of Clinical Oncology, Leiden University Medical Center (Netherlands); Nout, Remi A. [Department of Clinical Oncology, Leiden University Medical Center (Netherlands); Lybeert, Marnix L.M. [Department of Radiotherapy, Catharina Hospital Eindhoven (Netherlands); Warlam-Rodenhuis, Carla C. [Department of Radiation Oncology, University Medical Center Utrecht (Netherlands); Jobsen, Jan J. [Department of Radiotherapy, Medisch Spectrum Twente, Enschede (Netherlands); Mens, Jan-Willem M. [Department of Radiation Oncology, ErasmusMC-Daniel den Hoed Cancer Center, Rotterdam (Netherlands); Lutgens, Ludy C.H.W. [MAASTRO clinic, Maastricht (Netherlands); Pras, Elisabeth [Department of Radiotherapy, University Medical Center Groningen (Netherlands); Poll-Franse, Lonneke V. van de [Comprehensive Cancer Centre South, Eindhoven and Center of Research on Psychology in Somatic Diseases, Tilburg University (Netherlands); Putten, Wim L.J. van [Department of Biostatistics, ErasmusMC-Daniel den Hoed Cancer Center, Rotterdam (Netherlands)

    2011-11-15

    Purpose: To evaluate the very long-term results of the randomized Post Operative Radiation Therapy in Endometrial Carcinoma (PORTEC)-1 trial for patients with Stage I endometrial carcinoma (EC), focusing on the role of prognostic factors for treatment selection and the long-term risk of second cancers. Patients and Methods: The PORTEC trial (1990-1997) included 714 patients with Stage IC Grade 1-2 or Stage IB Grade 2-3 EC. After surgery, patients were randomly allocated to external-beam pelvic radiotherapy (EBRT) or no additional treatment (NAT). Analysis was by intention to treat. Results: 426 patients were alive at the date of analysis. The median follow-up time was 13.3 years. The 15-year actuarial locoregional recurrence (LRR) rates were 6% for EBRT vs. 15.5% for NAT (p < 0.0001). The 15-year overall survival was 52% vs. 60% (p = 0.14), and the failure-free survival was 50% vs. 54% (p = 0.94). For patients with high-intermediate risk criteria, the 15-year overall survival was 41% vs. 48% (p = 0.51), and the 15-year EC-related death was 14% vs. 13%. Most LRR in the NAT group were vaginal recurrences (11.0% of 15.5%). The 15-year rates of distant metastases were 9% vs. 7% (p = 0.25). Second primary cancers had been diagnosed over 15 years in 19% of all patients, 22% vs. 16% for EBRT vs. NAT (p = 0.10), with observed vs. expected ratios of 1.6 (EBRT) and 1.2 (NAT) compared with a matched population (p = NS). Multivariate analysis confirmed the prognostic significance of Grade 3 for LRR (hazard ratio [HR] 3.4, p = 0.0003) and for EC death (HR 7.3, p < 0.0001), of age >60 (HR 3.9, p = 0.002 for LRR and 2.7, p = 0.01 for EC death) and myometrial invasion >50% (HR 1.9, p = 0.03 and HR 1.9, p = 0.02). Conclusions: The 15-year outcomes of PORTEC-1 confirm the relevance of HIR criteria for treatment selection, and a trend for long-term risk of second cancers. EBRT should be avoided in patients with low- and intermediate-risk EC.

  7. Five-year evaluation of a low-shrinkage Silorane resin composite material: a randomized clinical trial.

    Science.gov (United States)

    Schmidt, Malene; Dige, Irene; Kirkevang, Lise-Lotte; Vaeth, Michael; Hørsted-Bindslev, Preben

    2015-03-01

    The aim of the present study was to investigate the clinical performance of a low-shrinkage silorane-based composite material (Filtek™ Silorane, 3 M-Espe) by comparing it with a methacrylate-based composite material (Ceram•X™, Dentsply DeTrey). A number of 72 patients (158 restorations) participated in the study. After 5 years, a total of 107 restorations (52 Filtek™ Silorane, 55 Ceram•X™) in 48 patients were evaluated. Only class II restorations were included. All the restorations were placed by the same dentist, and the restorations were scored by one experienced dentist/evaluator. Materials were applied following the manufacturer's instructions. The primary outcome was marginal adaptation. Secondary outcomes were: marginal discoloration, approximal contact, anatomic form, fracture, secondary caries, and hypersensitivity. After 5 years, no statistically significant differences between the two materials were found in marginal adaptation either occlusally (p = 0.96) or approximally (p = 0.62). No statistically significant differences were found between the two materials in terms of approximal contact, anatomic form, fractures, or discoloration. Secondary caries was found in two teeth (Filtek™ Silorane). One tooth showed hypersensitivity (Ceram•X™). Restorations of both materials were clinically acceptable after 5 years. This study did not find any advantage of the silorane-based composite over the methacrylate-based composite, which indicates that the low-shrinkage of Filtek™ Silorane may not be a determinant factor for clinical success in class II cavities. This paper is the first to evaluate the 5-year clinical performance of a low-shrinkage composite material.

  8. Recruitment to and pilot results of the PACES randomized trial of physical exercise during adjuvant chemotherapy for colon cancer.

    Science.gov (United States)

    van Waart, Hanna; Stuiver, Martijn M; van Harten, Wim H; Geleijn, Edwin; de Maaker-Berkhof, Marianne; Schrama, Jolanda; Geenen, Maud M; Meerum Terwogt, Jetske M; van den Heiligenberg, Simone M; Hellendoorn-van Vreeswijk, Jeannette A J H; Sonke, Gabe S; Aaronson, Neil K

    2018-01-01

    We report the recruitment rate, reasons for and factors influencing non-participation, and descriptive results of a randomized controlled trial of two different exercise programs for patients with colon cancer undergoing adjuvant chemotherapy. Participants were randomized to a low-intensity, home-based program (Onco-Move), a moderate- to high-intensity, combined supervised resistance and aerobic exercise program (OnTrack), or Usual Care. Non-participants provided reasons for non-participation and were asked to complete a questionnaire assessing behavioral and attitudinal variables. Trial participants completed performance-based and self-reported outcome measures prior to randomization, at the end of chemotherapy, and at the 6-month follow-up. Twenty-three of 63 referred patients agreed to participate in the trial. All 40 non-participants provided reasons for non-participation. Forty-five percent of the non-participants completed the questionnaire. Those who did not want to exercise had higher fatigue scores at baseline and a more negative attitude toward exercise. Compliance to both programs was high and no adverse events occurred. On average, the colon cancer participants were able to maintain or improve their physical fitness levels and maintain or decrease their fatigue levels during chemotherapy and follow-up. Recruitment of patients with colon cancer to a physical exercise trial during adjuvant chemotherapy proved to be difficult, underscoring the need to develop more effective strategies to increase participation rates. Both home-based and supervised programs are safe and feasible in patients with colon cancer undergoing chemotherapy. Effectiveness needs to be established in a larger trial. Netherlands Trial Register - NTR2159.

  9. Reducing chemotherapy use in clinically high-risk, genomically low-risk pN0 and pN1 early breast cancer patients: five-year data from the prospective, randomised phase 3 West German Study Group (WSG) PlanB trial.

    Science.gov (United States)

    Nitz, Ulrike; Gluz, Oleg; Christgen, Matthias; Kates, Ronald E; Clemens, Michael; Malter, Wolfram; Nuding, Benno; Aktas, Bahriye; Kuemmel, Sherko; Reimer, Toralf; Stefek, Andrea; Lorenz-Salehi, Fatemeh; Krabisch, Petra; Just, Marianne; Augustin, Doris; Liedtke, Cornelia; Chao, Calvin; Shak, Steven; Wuerstlein, Rachel; Kreipe, Hans H; Harbeck, Nadia

    2017-10-01

    The prospective phase 3 PlanB trial used the Oncotype DX ® Recurrence Score ® (RS) to define a genomically low-risk subset of clinically high-risk pN0-1 early breast cancer (EBC) patients for treatment with adjuvant endocrine therapy (ET) alone. Here, we report five-year data evaluating the prognostic value of RS, Ki-67, and other traditional clinicopathological parameters. A central tumour bank was prospectively established within PlanB. Following an early amendment, hormone receptor (HR)+ , pN0-1 RS ≤ 11 patients were recommended to omit chemotherapy. Patients with RS ≥ 12, pN2-3, or HR-negative/HER2-negative disease were randomised to anthracycline-containing or anthracycline-free chemotherapy. Primary endpoint: disease-free survival (DFS). PlanB Clinicaltrials.gov identifier: NCT01049425. From 2009 to 2011, PlanB enrolled 3198 patients (central tumour bank, n = 3073) with the median age of 56 years, 41.1% pN+, and 32.5% grade 3 EBC. Chemotherapy was omitted in 348/404 (86.1%) eligible RS ≤ 11 patients. After 55 months of median follow-up, five-year DFS in ET-treated RS ≤ 11 patients was 94% (in both pN0 and pN1) versus 94% (RS 12-25) and 84% (RS > 25) in chemotherapy-treated patients (p 2 cm, and RS, but not IHC4 or Ki-67 were independent adverse factors. If RS was excluded, IHC4 or both Ki-67 and PR entered the model. The impact of RS was particularly pronounced in patients with intermediate Ki-67 (>10%, risk, genomically low-risk (RS ≤ 11) pN0-1 patients without adjuvant chemotherapy support using RS with standardised pathology for treatment decisions in HR+ HER2-negative EBC. Ki-67 has the potential to support patient selection for genomic testing.

  10. Five Years of Cyclotron Radioisotope Production Experiences at the First PET-CT in Venezuela

    International Nuclear Information System (INIS)

    Colmenter, L.; Coelho, D.; Esteves, L. M.; Ruiz, N.; Morales, L.; Lugo, I.; Sajo-Bohus, L.; Liendo, J. A.; Greaves, E. D.; Barros, H.; Castillo, J.

    2007-01-01

    Five years operation of a compact cyclotron installed at PET-CT facility in Caracas, Venezuela is given. Production rate of 18 F labeled FDG, operation and radiation monitoring experience are included. We conclude that 18 FDG CT-PET is the most effective technique for patient diagnosis

  11. Family accommodation in obsessive-compulsive and anxiety disorders: a five-year update.

    Science.gov (United States)

    Lebowitz, Eli R; Panza, Kaitlyn E; Bloch, Michael H

    2016-01-01

    Family accommodation describes changes that individuals make to their behavior, to help their relative who is dealing with a psychiatric and/or psychological disorder(s), avoid or alleviate distress related to the disorder. Research on family accommodation has advanced rapidly. In this update we aim to provide a synthesis of findings from the past five years. A search of available, peer-reviewed, English language papers was conducted through PubMed and PsycINFO, cross referencing psychiatric disorders with accommodation and other family-related terms. The resulting 121 papers were individually reviewed and evaluated and the main findings were discussed. Family accommodation is common in obsessive-compulsive disorder (OCD) and in anxiety disorders, and manifests similarly across these disorders. Family accommodation is associated with more severe psychopathology and poorer clinical outcomes. Treatments have begun to focus on the reduction of family accommodation as a primary therapeutic goal and finally, neurobiological underpinnings of family accommodation are beginning to be investigated.

  12. Assessment of Peer-Led Team Learning in Calculus I: A Five-Year Study

    Science.gov (United States)

    Merkel, John Conrad; Brania, Abdelkrim

    2015-01-01

    This five-year study of the peer-led team learning (PLTL) paradigm examined its implementation in a Calculus I course at an all-male HBCU institution. For this study we set up a strong control group and measured the effect of PLTL in the teaching and learning of Calculus I through two points of measure: retention and success rates and learning…

  13. Minimal improvement of nurses’ motivational interviewing skills in routine diabetes care one year after training: a cluster randomized trial

    Science.gov (United States)

    2013-01-01

    Background The effectiveness of nurse-led motivational interviewing (MI) in routine diabetes care in general practice is inconclusive. Knowledge about the extent to which nurses apply MI skills and the factors that affect the usage can help to understand the black box of this intervention. The current study compared MI skills of trained versus non-trained general practice nurses in diabetes consultations. The nurses participated in a cluster randomized trial in which a comprehensive program (including MI training) was tested on improving clinical parameters, lifestyle, patients’ readiness to change lifestyle, and quality of life. Methods Fifty-eight general practices were randomly assigned to usual care (35 nurses) or the intervention (30 nurses). The ratings of applying 24 MI skills (primary outcome) were based on five consultation recordings per nurse at baseline and 14 months later. Two judges evaluated independently the MI skills and the consultation characteristics time, amount of nurse communication, amount of lifestyle discussion and patients’ readiness to change. The effect of the training on the MI skills was analysed with a multilevel linear regression by comparing baseline and the one-year follow-up between the interventions with usual care group. The overall effect of the consultation characteristics on the MI skills was studied in a multilevel regression analyses. Results At one year follow up, it was demonstrated that the nurses improved on 2 of the 24 MI skills, namely, “inviting the patient to talk about behaviour change” (mean difference=0.39, p=0.009), and “assessing patient’s confidence in changing their lifestyle” (mean difference=0.28, p=0.037). Consultation time and the amount of lifestyle discussion as well as the patients’ readiness to change health behaviour was associated positively with applying MI skills. Conclusions The maintenance of the MI skills one year after the training program was minimal. The question is whether

  14. Five-year follow-up of cognitive impairment in older adults with bipolar disorder.

    Science.gov (United States)

    Schouws, Sigfried N T M; Comijs, Hannie C; Dols, Annemieke; Beekman, Aartjan T F; Stek, Max L

    2016-03-01

    To date, cognitive impairment has been thought to be an integral part of bipolar disorder. In clinical staging models, cognitive impairment is one of the hallmarks to define the clinical stage and it plays an important role in identifying the risk factors for progression to later stages of the illness. It is important to examine neurocognitive performance over longer periods to test the hypothesis of neuroprogression of bipolar disorder. A comprehensive neuropsychological test battery was applied at baseline and five years later to 56 euthymic older outpatients with bipolar disorder (mean age = 68.35 years, range: 60-90 years) and to a demographically matched sample of 44 healthy subjects. A group-by-time repeated measures multivariate analysis of variance was performed to measure changes over time for the two groups. The impact of baseline illness characteristics on the intra-individual change in neurocognitive performance within the bipolar disorder group was studied by using logistic regression analysis. At baseline and at follow-up, patients with bipolar disorder performed worse on all neurocognitive measures compared to the matched healthy subjects. However, there was no significant group-by-time interaction between the patients with bipolar disorder and the comparison group. Although older patients with bipolar disorder had worse cognitive function than healthy subjects, they did not have greater cognitive decline over a five-year period. The change in acquired cognitive impairment of patients with bipolar disorder might parallel the cognitive development as seen in normal aging. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  15. CYTOLOGICAL EVALUATION OF MALE BREAST LESIONS IN GREATER GWALIOR : A FIVE YEAR RETROSPECTIVE STUDY

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    Jagannath

    2015-03-01

    Full Text Available BACKGROUNDS: Fine needle aspiration cytology is an effective modality for diagnosis of breast lesions. Usually male breast lesions are benign and affect the young male. Most common lesion is gynaecomastia. Male breast cancer accounts for a small proportion of breast cancers. Male breast cancer usually presents at an advanced age. OBJECTIVE: The aim of this study was to examine the nature of male breast lesions and to determine the cytomorphologic patterns of these lesions. MET HODS: five year retrospective study was conducted in our institution and in that 112 patients underwent fine needle aspiration cytology of the palpable breast lump after thorough physical examination. The cytological diagnosis was classified as benign, inf lammatory, malignant and others. RESULTS: In 112 male patients diagnosed with breast lesions, the most common lesion was gynecomastia (103/112, 91.9%, followed by breast cancer (6/112, 5.4%, inflammatory (2/112, 1.8% and apocrine metaplasia (01/112, 0.9 %. Gynecomastia was commonly found in male patients less than 40 years of age, while breast cancer is seen in male patients over 40 years of age

  16. Five-Year Incidence of Chronic Kidney Disease (Stage 3-5) and Associated Risk Factors in a Spanish Cohort: The MADIABETES Study

    Science.gov (United States)

    Salinero-Fort, Miguel A.; San Andrés-Rebollo, Francisco J.; de Burgos-Lunar, Carmen; Gómez-Campelo, Paloma; Chico-Moraleja, Rosa M.; López de Andrés, Ana; Jiménez-García, Rodrigo

    2015-01-01

    Objective To evaluate the incidence rate of Chronic Kidney Disease (CKD) stage 3-5 (persistent decreased kidney function under 60 mL/min per 1.73 m2) among patients with type 2 diabetes over five years, to identify the risk factors associated with CKD, and develop a risk table to predict five-year CKD stage 3-5 risk stratification for clinical use. Design The MADIABETES Study is a prospective cohort study of 3,443 outpatients with type 2 diabetes mellitus, sampled from 56 primary health care centers (131 general practitioners) in Madrid (Spain). Results The cumulative incidence of CKD stage 3-5 at five-years was 10.23% (95% CI = 9.12–11.44) and the incidence density was 2.07 (95% CI = 1.83–2.33) cases per 1,000 patient-months or 2.48 (95% CI = 2.19–2.79) cases per 100 patient-years. The highest hazard ratio (HR) for developing CKD stage 3-5 was albuminuria ≥300 mg/g (HR = 4.57; 95% CI= 2.46-8.48). Furthermore, other variables with a high HR were age over 74 years (HR = 3.20; 95% CI = 2.13–4.81), a history of Hypertension (HR = 2.02; 95% CI = 1.42–2.89), Myocardial Infarction (HR= 1.72; 95% IC= 1.25–2.37), Dyslipidemia (HR = 1.68; 95% CI 1.30–2.17), duration of diabetes mellitus ≥ 10 years (HR = 1.46; 95% CI = 1.14-1.88) and Systolic Blood Pressure >149 mmHg (HR = 1.52; 95% CI = 1.02–2.24). Conclusions After a five-year follow-up, the cumulative incidence of CKD is concordant with rates described in Spain and other countries. Albuminuria ≥ 300 mg/g and age over 74 years were the risk factors more strongly associated with developing CKD (Stage 3-5). Blood Pressure, lipid and albuminuria control could reduce CKD incidence of CKD in patients with T2DM. PMID:25856231

  17. Promoting mobility after hip fracture (ProMo: study protocol and selected baseline results of a year-long randomized controlled trial among community-dwelling older people

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    Sipilä Sarianna

    2011-12-01

    Full Text Available Abstract Background To cope at their homes, community-dwelling older people surviving a hip fracture need a sufficient amount of functional ability and mobility. There is a lack of evidence on the best practices supporting recovery after hip fracture. The purpose of this article is to describe the design, intervention and demographic baseline results of a study investigating the effects of a rehabilitation program aiming to restore mobility and functional capacity among community-dwelling participants after hip fracture. Methods/Design Population-based sample of over 60-year-old community-dwelling men and women operated for hip fracture (n = 81, mean age 79 years, 78% were women participated in this study and were randomly allocated into control (Standard Care and ProMo intervention groups on average 10 weeks post fracture and 6 weeks after discharged to home. Standard Care included written home exercise program with 5-7 exercises for lower limbs. Of all participants, 12 got a referral to physiotherapy. After discharged to home, only 50% adhered to Standard Care. None of the participants were followed-up for Standard Care or mobility recovery. ProMo-intervention included Standard Care and a year-long program including evaluation/modification of environmental hazards, guidance for safe walking, pain management, progressive home exercise program and physical activity counseling. Measurements included a comprehensive battery of laboratory tests and self-report on mobility limitation, disability, physical functional capacity and health as well as assessments for the key prerequisites for mobility, disability and functional capacity. All assessments were performed blinded at the research laboratory. No significant differences were observed between intervention and control groups in any of the demographic variables. Discussion Ten weeks post hip fracture only half of the participants were compliant to Standard Care. No follow-up for Standard Care or

  18. Pharmaceutical companies' policies on access to trial data, results, and methods: audit study.

    Science.gov (United States)

    Goldacre, Ben; Lane, Síle; Mahtani, Kamal R; Heneghan, Carl; Onakpoya, Igho; Bushfield, Ian; Smeeth, Liam

    2017-07-26

    Objectives  To identify the policies of major pharmaceutical companies on transparency of trials, to extract structured data detailing each companies' commitments, and to assess concordance with ethical and professional guidance. Design  Structured audit. Setting  Pharmaceutical companies, worldwide. Participants  42 pharmaceutical companies. Main outcome measures  Companies' commitments on sharing summary results, clinical study reports (CSRs), individual patient data (IPD), and trial registration, for prospective and retrospective trials. Results  Policies were highly variable. Of 23 companies eligible from the top 25 companies by revenue, 21 (91%) committed to register all trials and 22 (96%) committed to share summary results; however, policies commonly lacked timelines for disclosure, and trials on unlicensed medicines and off-label uses were only included in six (26%). 17 companies (74%) committed to share the summary results of past trials. The median start date for this commitment was 2005. 22 companies (96%) had a policy on sharing CSRs, mostly on request: two committed to share only synopses and only two policies included unlicensed treatments. 22 companies (96%) had a policy to share IPD; 14 included phase IV trials (one included trials on unlicensed medicines and off-label uses). Policies in the exploratory group of smaller companies made fewer transparency commitments. Two companies fell short of industry body commitments on registration, three on summary results. Examples of contradictory and ambiguous language were documented and summarised by theme. 23/42 companies (55%) responded to feedback; 7/1806 scored policy elements were revised in light of feedback from companies (0.4%). Several companies committed to changing policy; some made changes immediately. Conclusions  The commitments made by companies to transparency of trials were highly variable. Other than journal submission for all trials within 12 months, all elements of best practice

  19. Longitudinal Impact of the Project PATHS on Adolescent Risk Behavior: What Happened after Five Years?

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    Daniel T. L. Shek

    2012-01-01

    Full Text Available The present study investigated the longitudinal impact of the Project PATHS, a large-scale curriculum-based positive youth development program in Hong Kong, on the development of adolescents’ risk behavior over a period of five years. Using a longitudinal randomized controlled design, eight waves of data were collected from 19 experimental schools in which students participated in the Project PATHS (=2,850 at Wave 8 and 24 control schools without joining the Project PATHS (=3,640 at Wave 8. At each wave, students responded to measures assessing their current risk behaviors, including delinquency, use of different types of drug, and their intentions of participating in risk behaviors in the future. Results demonstrated that adolescents receiving the program exhibited significantly slower increases in delinquent behaviors and substance use as compared to the control participants. During two years after the completion of the program, differences in youth risk behaviors in the two groups still existed. These results suggest that the Project PATHS has long-term effect in preventing adolescent problem behavior through promoting positive youth development.

  20. Anti-HBs in immunized children with cuban hepatitis B vaccine and impact of booster dose after five years

    International Nuclear Information System (INIS)

    Dahifar, H.; Mousavi, F.; Ghorbani, A.

    2008-01-01

    Hepatitis B virus infection and associated diseases are a major public health problem. This study was planned to find out the persistence of antibody against hepatitis B surface antigen in Iranian vaccinated children after five years. Anti-HBs titers in a group of healthy good - responder children who were vaccinated with Cuban hepatitis B vaccine in infancy were measured after five years. Children with antibody titers <100 mlU/ml were revaccinated and retested after four weeks. Mean anti-HBs titers in 68 children (29 females, 39 males) were 482.1 mlU/ml at six months after the third dose of primary vaccination and 153 mlU/ml at five years later. Total mean anti-HBs titers in 36 (52.9%) children out of 68 (17 females, 19 males) were 38.3 mlU/ml and 4(5.8%) of 68 children (two of each sexes) had no detectable antibody after five years. Total mean anti-HBs titers in these hypo- responder and non- responder were 774.3 mlU/ml and 625.5 mlU/ml respectively after booster dose. In a group of children, who were immunized with Cuban hepatitis B vaccine from birth, anti-HBS titers fell at 6.5 years of age and almost half of children became hypo responder or no responder and their anti-HBs titers developed secondary rise after booster vaccination. All children showed immunologic memory to a booster dose. (author)

  1. Letter to the Editor: Re: A Five-year Survey of Cesarean Delivery at a ...

    African Journals Online (AJOL)

    Letter to the Editor: Re: A Five-year Survey of Cesarean Delivery at a Nigerian Tertiary Hospital. VO Ajuzieogu, AO Amucheazi. Abstract. Letter to the editor - no abstract. Full Text: EMAIL FREE FULL TEXT EMAIL FREE FULL TEXT · DOWNLOAD FULL TEXT DOWNLOAD FULL TEXT. Article Metrics. Metrics Loading .

  2. Changes of attachment characteristics during psychotherapy of patients with social anxiety disorder: Results from the SOPHO-Net trial.

    Science.gov (United States)

    Strauß, Bernhard; Altmann, Uwe; Manes, Susanne; Tholl, Anne; Koranyi, Susan; Nolte, Tobias; Beutel, Manfred E; Wiltink, Jörg; Herpertz, Stephan; Hiller, Wolfgang; Hoyer, Jürgen; Joraschky, Peter; Nolting, Björn; Ritter, Viktoria; Stangier, Ulrich; Willutzki, Ulrike; Salzer, Simone; Leibing, Eric; Leichsenring, Falk; Kirchmann, Helmut

    2018-01-01

    Within a randomized controlled trial contrasting the outcome of manualized cognitive-behavioral (CBT) and short term psychodynamic therapy (PDT) compared to a waiting list condition (the SOPHO-Net trial), we set out to test whether self-reported attachment characteristics change during the treatments and if these changes differ between treatments. 495 patients from the SOPHO-Net trial (54.5% female, mean age 35.2 years) who were randomized to either CBT, PDT or waiting list (WL) completed the partner-related revised Experiences in Close Relationships Questionnaire (ECR-R) before and after treatment and at 6 and 12 months follow-up. The Liebowitz Social Anxiety Scale (LSAS) was administered at pre-treatment, post-treatment, and at 6-month and 1-year follow-up. ECR-R scores were first compared to a representative healthy sample (n = 2508) in order to demonstrate that the clinical sample differed significantly from the non-clinical sample with respect to attachment anxiety and avoidance. LSAS scores correlated significantly with both ECR-R subscales. Post-therapy, patients treated with CBT revealed significant changes in attachment anxiety and avoidance whereas patients treated with PDT showed no significant changes. Changes between post-treatment and the two follow-ups were significant in both conditions, with minimal (insignificant) differences between treatments at the 12- month follow-up. The current study supports recent reviews of mostly naturalistic studies indicating changes in attachment as a result of psychotherapy. Although there were differences between conditions at the end of treatment, these largely disappeared during the follow-up period which is line with the other results of the SOPHO-NET trial. Controlled-trials.com ISRCTN53517394.

  3. Daily portraits of five and six-year old boys: the play activity

    Directory of Open Access Journals (Sweden)

    Flavia Bignardi da Silva Nunes

    2013-08-01

    Full Text Available Introduction: Daily life experiences provide maturity along human development, and the environments in which they occur are essential for this process. These experiences help to build children’s personalities and the way they deal with the world around them. Objectives: In this study, we aimed to understand the occupational behavior of four children aged five to six years old through their mothers’ reports. Methodology: The average time spent with daily activities is described, and playing was a central theme of analysis. We analyzed the preferences, companies and emotional characteristics of the play activity. We used an Activity Clock and semi-structured interviews with the children’s mothers as data collection instruments. Results: The main results show that most of their daily life time is spent with sleep, school and play activities. They indicate that children prefer games that challenge acquisitions that are under construction. Regarding company, these children still have their mothers as a reference to the play activity, but also peers their age or a little older. Conclusion: Play has an important representation in the daily occupational lives of these children and it stands as a key life experience to acquire skills and face challenges.

  4. Changes in body mass index in Canadians over a five-year period: Results of a prospective, population-based study

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    Poliquin Suzette

    2007-07-01

    Full Text Available Abstract Background The initiation of the Canadian Multicentre Osteoporosis Study in 1996, and subsequent follow-up of the cohort 5 years later, provided longitudinal body mass index (BMI data for a random sample of Canadians. Methods Height and weight were measured at baseline and 5 years and used to calculate BMI and assign one of six weight categories. Multiple imputation was used to adjust for missing weight at year 5. Data were stratified by age and gender. The proportion of participants moving between categories was generated, and multivariable linear regression was used to identify factors associated with weight change. Results Baseline data were available for 8548 participants, year 5 data for 6721, and year 5 weight was imputed for 1827 (17.6%. Mean BMI for every age and gender group exceeded healthy weight guidelines. Most remained within their BMI classification over 5 years, but when change occurred, BMI category was more likely to increase than decrease. Several sociodemographic, lifestyle and clinical characteristics were associated with change. Conclusion Mean baseline BMI tended to be higher than recommended. Moreover, on average, men under age 45 and women under age 55 were gaining approximately 0.45 kilograms (one pound per year, which leveled off with increased age and reversed in the oldest age groups. These findings underscore the need for public health efforts aimed at combating obesity.

  5. Two-year follow-up results for Hip-Hop to Health Jr.: a randomized controlled trial for overweight prevention in preschool minority children.

    Science.gov (United States)

    Fitzgibbon, Marian L; Stolley, Melinda R; Schiffer, Linda; Van Horn, Linda; KauferChristoffel, Katherine; Dyer, Alan

    2005-05-01

    To assess the impact of a culturally proficient dietary/physical activity intervention on changes in body mass index (BMI) (kg/m 2 ). Randomized controlled trial (Hip-Hop to Health Jr.) conducted between September 1999 and June 2002 in 12 Head Start preschool programs in Chicago, Illinois. Intervention children had significantly smaller increases in BMI compared with control children at 1-year follow-up, 0.06 vs 0.59 kg/m 2 ; difference -0.53 kg/m 2 (95% CI -0.91 to -0.14), P = .01; and at 2-year follow-up, 0.54 vs 1.08 kg/m 2 ; difference -0.54 kg/m 2 (95% CI -0.98 to -0.10), P = .02, with adjustment for baseline age and BMI. The only significant difference between intervention and control children in food intake/physical activity was the Year 1 difference in percent of calories from saturated fat, 11.6% vs 12.8% ( P = .002). Hip-Hop to Health Jr. was effective in reducing subsequent increases in BMI in preschool children. This represents a promising approach to prevention of overweight among minority children in the preschool years.

  6. Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial.

    Science.gov (United States)

    Alfonso, Fernando; Pérez-Vizcayno, María José; García Del Blanco, Bruno; Otaegui, Imanol; Masotti, Mónica; Zueco, Javier; Veláquez, Maite; Sanchís, Juan; García-Touchard, Arturo; Lázaro-García, Rosa; Moreu, José; Bethencourt, Armando; Cuesta, Javier; Rivero, Fernando; Cárdenas, Alberto; Gonzalo, Nieves; Jiménez-Quevedo, Pilar; Fernández, Cristina

    2016-06-27

    The aim of this study was to compare the long-term efficacy of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in patients with bare-metal stent in-stent restenosis (ISR). The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown. The 3-year clinical follow-up (pre-specified endpoint) of patients included in the RIBS V (Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent Implantation) randomized clinical trial was analyzed. All patients were followed yearly using a pre-defined structured questionnaire. A total of 189 patients with bare-metal stent ISR were allocated to either EES (n = 94) or DEB (n = 95). Clinical follow-up at 1, 2, and 3 years was obtained in all patients (100%). Compared with patients treated with DEB, those treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up (primary study endpoint; 2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; p 1 year) target vessel (3 [3.2%] vs. 3 [3.2%]; p = 0.95) and target lesion (1 [1%] vs. 2 [2.1%]; p = 0.54) revascularization was low and similar in the 2 arms. Rates of definite or probable stent thrombosis (1% vs. 0%) were also similar in the 2 arms. The 3-year clinical follow-up of the RIBS V clinical trial confirms the sustained safety and efficacy of EES and DEB in patients treated for bare-metal stent ISR. In this setting, EES reduce the need for target lesion revascularization at very long-term follow-up. (RIBS V [Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent] [RIBS V]; NCT01239953). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  7. Glycemic indices of five varieties of dates in healthy and diabetic subjects

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    Gariballa Salah

    2011-05-01

    Full Text Available Abstract Background This study was designed to determine the glycemic indices of five commonly used varieties of dates in healthy subjects and their effects on postprandial glucose excursions in individuals with type 2 diabetes mellitus. Methods Composition analysis was carried out for five types of dates (Tamer stage. The weights of the flesh of the dates equivalent to 50 g of available carbohydrates were calculated. The study subjects were thirteen healthy volunteers with a mean (± SD age of 40.2 ± 6.7 years and ten participants with type 2 diabetes mellitus (controlled on lifestyle measures and/or metformin with a mean HbA1c (± SD of 6.6 ± (0.7% and a mean age (± SD of 40.8 ± 5.7 years. Each subject was tested on eight separate days with 50 g of glucose (on 3 occasions and 50 g equivalent of available carbohydrates from the 5 varieties of date (each on one occasion. Capillary glucose was measured in the healthy subjects at 0, 15, 30, 45, 60, 90 and 120 min and for the diabetics at 0, 30, 60, 90, 120, 150 and 180 min. The glycemic indices were determined as ratios of the incremental areas under the response curves for the dates compared to glucose. Statistical analyses were performed using the Mann-Whitney U test and repeated measures analysis of variance. Results Mean glycemic indices ± SEM of the dates for the healthy individuals were 54.0 ± 6.1, 53.5 ± 8.6, 46.3 ± 7.1, 49.1 ± 3.6 and 55.1 ± 7.7 for Fara'd, Lulu, Bo ma'an, Dabbas and Khalas, respectively. Corresponding values for those with type 2 diabetes were very similar (46.1 ± 6.2, 43.8 ± 7.7, 51.8 ± 6.9, 50.2 ± 3.9 and 53.0 ± 6.0. There were no statistically significant differences in the GIs between the control and the diabetic groups for the five types of dates, nor were there statistically significant differences among the dates' GIs (df = 4, F = 0.365, p = 0.83. Conclusion The results show low glycemic indices for the five types of dates included in the study and

  8. Twenty-five years of transient counting experience in French PWR units

    Energy Technology Data Exchange (ETDEWEB)

    Barthelet, B. [Electricite de France (EDF DPN), 93 - Saint-Denis (France); Savoldelli, D.; Fritz, R. [Electricite de France (EDF DPN), 93 - Noisy le Grand (France)

    2001-07-01

    For nearly twenty five years, EDF has been checking that the actual operating transients are neither more severe nor more numerous than the design basis transients. This activity of transient cycle counting and bookkeeping has enabled EDF to own a database of more than 800 reactor.years for the PWR units. The current method of transient cycle counting is presented. In the paper, we will point out the main results of transient cycle counting and lessons learned. In general, the frequencies of transients are lower than the design frequencies. In few cases, they are higher, such as the transient frequencies of the RCS lines connected to auxiliary systems often due to operating procedures or particular periodic testing. Few periodic tests were not taken into account in the design basis transient file ; they have been detected thanks to the transient cycle counting. In the last 1980's, we achieved the first updating of the design basis transient file for the PWR 900 MWe series. In the early 1990's, we updated the design basis transient file of the PWR 1300 MWe series. In fact, since design and start-up, the operating conditions have been modified (fuel cycle with stretch-out, modification of the hot leg and cold leg temperatures for the PWR 1300 MWe,...). This was the cause of many unclassified transients. In the new design basis transient file, we have created new transients and increased the frequencies of some of them. This has enabled to consider the updated design basis transient file more representative of actual operating transients. For some years, we have increasingly associated the operators with the transient cycle counting concern. We noticed progress (decreased frequencies of most transients). (authors)

  9. Twenty-five years of transient counting experience in French PWR units

    International Nuclear Information System (INIS)

    Barthelet, B.; Savoldelli, D.; Fritz, R.

    2001-01-01

    For nearly twenty five years, EDF has been checking that the actual operating transients are neither more severe nor more numerous than the design basis transients. This activity of transient cycle counting and bookkeeping has enabled EDF to own a database of more than 800 reactor.years for the PWR units. The current method of transient cycle counting is presented. In the paper, we will point out the main results of transient cycle counting and lessons learned. In general, the frequencies of transients are lower than the design frequencies. In few cases, they are higher, such as the transient frequencies of the RCS lines connected to auxiliary systems often due to operating procedures or particular periodic testing. Few periodic tests were not taken into account in the design basis transient file ; they have been detected thanks to the transient cycle counting. In the last 1980's, we achieved the first updating of the design basis transient file for the PWR 900 MWe series. In the early 1990's, we updated the design basis transient file of the PWR 1300 MWe series. In fact, since design and start-up, the operating conditions have been modified (fuel cycle with stretch-out, modification of the hot leg and cold leg temperatures for the PWR 1300 MWe,...). This was the cause of many unclassified transients. In the new design basis transient file, we have created new transients and increased the frequencies of some of them. This has enabled to consider the updated design basis transient file more representative of actual operating transients. For some years, we have increasingly associated the operators with the transient cycle counting concern. We noticed progress (decreased frequencies of most transients). (authors)

  10. Triticale in the years with extreme weather conditions

    Directory of Open Access Journals (Sweden)

    Nožinić Miloš

    2009-01-01

    Full Text Available Unlike other grain crops, the area under triticale in the Republic of Srpska has been expanding every year. Since the introduction of this plant species in the broad production began a few years ago, the finding of the optimal variety agrotechnique in different environmental conditions has great importance. This paper deals with the results of the trials from seven locations in two very extreme vegetation seasons (2002/03, 2006/07. High yield of triticale on the location Banja Luka (150 m alt. with five triticale varieties in four sowing rates in the replication trial in very unfavorable weather conditions in 2003, points to emphasized triticale tolerance to high temperatures and drought. High grain yield of triticale in the trials on the locations Banja Luka, Butmir (460 m alt. and Živince (230 m alt. was obtained in 2007 too, when all vegetation months had higher mean temperature than long term average, what is a unique appearance in the entire 'meteorological history'. In the paper the appearance of the earliest triticale heading is described and explained. It happened at one production trial on Manjača (250 m alt. in the first decade of March in 2007. On the another location on Manjača (450 m alt., in the macrotrial, rye showed much higher tolerance to extreme soil acidity, than triticale. Obtained results and unusual appearances on triticale are helpful for the further research of the stability and adaptability of more important triticale traits. .

  11. Type distribution of lymphomas in Lebanon: five-year single institution experience.

    Science.gov (United States)

    Sader-Ghorra, Claude; Rassy, Marc; Naderi, Samah; Kourie, Hampig Raphael; Kattan, Joseph

    2014-01-01

    Lymphomas represent the fifth most frequent cancer in Lebanon. However, little is known concerning epidemiologic characteristics and distribution of lymphoid neoplasms according to the 2008 WHO classification. We conducted a retrospective study of lymphoma cases diagnosed from 2008 till 2012 at Hotel-Dieu de France University Hospital. A total of 502 new cases of lymphoma were diagnosed at our institution during a five year period: 119 cases (24%) were Hodgkin lymphomas (HL) and 383 cases (76%) were non-Hodgkin lymphomas (NHL). HLs were equally distributed in both sexes with a mean age at diagnosis of 30 years. Among NHL, 87% (332 cases) were B cell lymphomas, 9% (34 cases) were T cell lymphomas and 4%(17 cases) were classified as precursor lymphoid neoplasms. Among B cell lymphomas, 44% (147 cases) were diffuse large B cell lymphomas (DLBCL), 20% (65 cases) follicular lymphomas and 8% (27 cases) mantle cell lymphomas. DLBCL were equally distributed in both sexes with a mean age of 58 years. Follicular lymphomas were characterized by a male predominance (57%) and a mean age of 60 years. Mantle cell lymphomas showed a pronounced male predominance (85%) with a mean age of 60 years in men and 70 years in women. Some 72% of patients having T cell lymphomas were men, with a mean age of 57 years in men and 45 years in women, while 65% of patients having precursor lymphoid neoplasms were women with a mean age of 22 years in women and 30 years in men. The lymphoma subtype distribution in Lebanon is unique when compared to other countries from around the world. In fact, Hodgkin and follicular lymphomas are more frequent than in most Far Eastern, European and American countries, while T-cell lymphomas and DLBCL are less frequent.

  12. Vertigo/dizziness in pediatric emergency department: Five years' experience.

    Science.gov (United States)

    Raucci, Umberto; Vanacore, Nicola; Paolino, Maria Chiara; Silenzi, Romina; Mariani, Rosanna; Urbano, Antonella; Reale, Antonino; Villa, Maria Pia; Parisi, Pasquale

    2016-05-01

    Vertigo/Dizziness in childhood is not a rare cause of visits to the emergency department (ED). We analyzed a selected group with vertigo/dizziness to identify signs and symptoms that may help to guide the diagnostic approach and management. A total of 616 children admitted for vertigo to the ED over a five-year period were retrospectively reviewed. Their medical history, clinical characteristics, laboratory and neuroimaging tests, final diagnoses and management were analyzed. Migraine and syncope were the most frequent causes. Two patients were affected by life-threatening cardiac syncope, while structural life-threatening central nervous system diseases were found in 15 patients, none of whom presented with vertigo as an isolated clinical finding. Most cases of vertigo/dizziness in childhood that consist mainly of migraine and syncope are of benign origin. The prompt identification of neurological or cardiological signs or symptoms associated with vertigo in children is mandatory to rule out life-threatening conditions. © International Headache Society 2015.

  13. Risk factors for dental caries in childhood: a five-year survival analysis.

    Science.gov (United States)

    Lee, Hyo-Jin; Kim, Jin-Bom; Jin, Bo-Hyoung; Paik, Dai-Il; Bae, Kwang-Hak

    2015-04-01

    The purpose of this study was to examine the risk factors of dental caries at the level of an individual person with survival analysis of the prospective data for 5 years. A total of 249 first-grade students participated in a follow-up study for 5 years. All participants responded to a questionnaire inquiring about socio-demographic variables and oral health behaviors. They also received an oral examination and were tested for Dentocult SM and LB. Over 5 years, the participants received yearly oral follow-up examinations to determine the incidence of dental caries. The incidence of one or more dental caries (DC1) and four or more dental caries (DC4) were defined as one or more and four or more decayed, missing, and filled permanent teeth increments, respectively. Socio-demographic variables, oral health behaviors, and status and caries activity tests were assessed as risk factors for DC1 and DC4. The adjusted hazard ratios (HRs) of risk factors for DC1 and DC4 were calculated using Cox proportional hazard regression models. During the 5-year follow-up period, DC1 and DC4 occurred in 87 and 25 participants, respectively. In multivariate hazard models, five or more decayed, missing, and filled primary molar teeth [HR 1.93, 95% confidence interval (CI) 1.19-3.13], and Dentocult LB of two or three (HR 2.21, 95% CI 1.37-3.56) were independent risk factors of DC1. For DC4, only Dentocult LB of two or three was an independent risk factor (HR 2.95, 95% CI 1.11-7.79). Our results suggest that dental caries incidence at an individual level can be associated with the experience of dental caries in primary teeth and Dentocult LB based on the survival models for the 5-year prospective data. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  14. Maxillary overdentures supported by four or six implants in the anterior region: 5-year results from a randomized controlled trial.

    Science.gov (United States)

    Slot, Wim; Raghoebar, Gerry M; Cune, Marco S; Vissink, Arjan; Meijer, Henny J A

    2016-12-01

    To compare a four- and six-implant maxillary overdenture after an observation period of 5 years. Fifty subjects with functional problems concerning their maxillary denture, who had ample bone volume in the anterior region to place four or six implants, were included and randomly assigned to either group. Implant and overdenture survival, clinical performance, marginal bone loss and patient satisfaction were assessed. Forty-six patients completed the 5-year follow-up. One implant failed in the six implants group (99.2% survival) and none in the four implants group (100% survival). No overdentures had to be replaced during the observation period and the number of complications was limited. Clinical function was good, with no difference in clinical parameters between the groups. Mean marginal bone resorption was 0.50 ± 0.37 and 0.52 ± 0.43 mm in the four and six implant group respectively. In patients with functional complaints of their maxillary denture, bar-supported overdentures on four implants in the anterior maxillary region were not inferior to overdentures supported by six implants after 5 years of function. Implant survival and patient satisfaction were high, clinical parameters favourable, bone loss and complications to the denture were minor in both groups (Clinical trial registration number: NTR2969). © 2016 The Authors. Journal of Clinical Periodontology Published by John Wiley & Sons Ltd.

  15. The incidence of mobility restrictions among elderly people in two Nordic localities. A five-year follow-up

    DEFF Research Database (Denmark)

    Sakari-Rantala, Ritva; Avlund, Kirsten; Frändin, Kerstin

    2002-01-01

    The aim of this study was to investigate the incidence of limitations in self-reported mobility as well as the decline in measured walking speed and stair-mounting ability over five years among men and women aged 75 at baseline in two Nordic localities. Another purpose was to analyze the relation......The aim of this study was to investigate the incidence of limitations in self-reported mobility as well as the decline in measured walking speed and stair-mounting ability over five years among men and women aged 75 at baseline in two Nordic localities. Another purpose was to analyze...

  16. Psycho-social activity factors associated with self-rated health among community-dwelling elderly people A five-year longitudinal study.

    Science.gov (United States)

    Yamauchi, Kanako; Saito, Isao; Kato, Tadahiro; Tanigawa, Takeshi; Kobayashi, Toshio

    2015-01-01

    This longitudinal study examined psychological and social activity factors related to poor self-rated health (SRH) in community-dwelling elderly people. The general health of 7,413 elderly individuals aged 65 years and over in Toon City, Ehime Prefecture, Japan was surveyed. We followed 4,372 participants, over a five-year period, after excluding those who were aged 85 years and over, had a disability, had moved away, or had died. The data from 3,358 respondents (response rate: 76.8%) were analyzed. We divided the patients into two groups based on their SRH responses: healthy, including those who answered "excellent" or "good," and unhealthy, including those who answered "not good" or "poor." We examined changes in SRH for both groups between the first survey and the survey conducted after five years. Among the healthy subjects at the first survey, we analyzed the relationship between SRH, after five years, and psycho-social activity factors using a logistic regression analysis. These factors included physical and social competence, life satisfaction, and tendency towards dementia and/or depression. SRH of both men and women significantly declined over five years. The percentage of men and women, who maintained SRH as healthy, after the 5-year follow-up period, was approximately 60% in those aged 65-74 years and 40% in those aged 75-84 years. In those aged 65-74 years, the odds ratio (OR) for a SRH of unhealthy (after five years), associated with Life Satisfaction Index-K (LSI-K) scores (at the first survey), was significantly lower at 0.85 (95% confidence interval [CI]: 0.77-0.93) for men and 0.79 (95% CI: 0.72-0.87) for women. The OR of tendency toward depression was significantly higher at 1.68 (95% CI: 1.11-2.56) for women only. In those aged 75-84 years, the OR for a SRH of unhealthy (after five years), associated with LSI-K scores (at the first survey), was significantly lower at 0.87 (95% CI: 0.77-1.00) for men and 0.89 (95% CI: 0.80-0.99) for women. The OR

  17. Conducting five-year plan and tri-party agreement community outreach activities at the U. S. Department Of Energy Richland Field Office

    International Nuclear Information System (INIS)

    Peterson, James M.; Brown, Madeleine C.

    1992-01-01

    For cleanup to succeed, the public must be informed and involved. Both the Tri-Party Agreement and the Five-Year Plan require significant public interactions. The Tri-Party Agreement has a community relations plan, and the Five-Year Plan has a rigorous community outreach agenda. Both recognize that the public must get every reasonable opportunity to learn about and to voice opinions about DOE's cleanup activities. Beginning this year, our Five-Year Plan public participation action plan will fold in all DOE Environmental Restoration and Waste Management outreach activities at Hanford. This supports the need we recognize to coordinate public involvement activities sitewide. (author)

  18. A 3-year randomized therapeutic trial of nitisinone in alkaptonuria.

    Science.gov (United States)

    Introne, Wendy J; Perry, Monique B; Troendle, James; Tsilou, Ekaterini; Kayser, Michael A; Suwannarat, Pim; O'Brien, Kevin E; Bryant, Joy; Sachdev, Vandana; Reynolds, James C; Moylan, Elizabeth; Bernardini, Isa; Gahl, William A

    2011-08-01

    Alkaptonuria is a rare, autosomal recessive disorder of tyrosine degradation due to deficiency of the third enzyme in the catabolic pathway. As a result, homogentisic acid (HGA) accumulates and is excreted in gram quantities in the urine, which turns dark upon alkalization. The first symptoms, occurring in early adulthood, involve a painful, progressively debilitating arthritis of the spine and large joints. Cardiac valvular disease and renal and prostate stones occur later. Previously suggested therapies have failed to show benefit, and management remains symptomatic. Nitisinone, a potent inhibitor of the second enzyme in the tyrosine catabolic pathway, is considered a potential therapy; proof-of-principle studies showed 95% reduction in urinary HGA. Based on those findings, a prospective, randomized clinical trial was initiated in 2005 to evaluate 40 patients over a 36-month period. The primary outcome parameter was hip total range of motion with measures of musculoskeletal function serving as secondary parameters. Biochemically, this study consistently demonstrated 95% reduction of HGA in urine and plasma over the course of 3 years. Clinically, primary and secondary parameters did not prove benefit from the medication. Side effects were infrequent. This trial illustrates the remarkable tolerability of nitisinone, its biochemical efficacy, and the need to investigate its use in younger individuals prior to development of debilitating arthritis. Published by Elsevier Inc.

  19. The safeguards on-site laboratory at Sellafield. Five years operational experience

    Energy Technology Data Exchange (ETDEWEB)

    Duinslaeger, L.; Belle, P. van; Mayer, K.; Casteleyn, K.; Abousahl, S.; Daures, P.; Eberle, H.; Enright, T.; Guiot, A.; Hild, M.; Horta Domenech, J.; Lajarge, P.; Laurent, P.; Le Terrier, A.; Lynch, B.; Marucci, M.; Millet, S.; Ottmar, H.; Richir, P.; Street, S.; Vallet, P.; Zuleger, E. [European Commission, Karlsruhe (Germany). Inst. for Transuranium Elements

    2004-06-01

    The start of operation of the large reprocessing facilities led Euratom Safeguards to a new approach for verification analysis of samples taken at the facility: the installation of on-site laboratories. The availability of analytical capabilities for independent verification measurements at the site of these facilities offers obvious advantages in view of timeliness of results. The 'On-Site Laboratory' (OSL) at the BNFL Sellafield site was the first ever and entered into operation in 1999. For almost five years, the Institute for Transuranium Elements (ITU) has been operating the laboratory under routine conditions. During this period, more than one thousand safeguards samples were analysed. The experience gained in the management, logistics and operation of the OSL allow a critical review based on a significant period in time. This includes also aspects of training of staff, maintenance of equipment, flow of information, and improvements in the efficiency. The analytical issues are of key importance: based on the operational experience, the measurement methods were adapted (changing boundary conditions), the distribution of samples according to material type changed (start up of MOS fabrication plant), and the cutback in resources triggered a further streamlining of the analytical efforts. (orig.)

  20. A pragmatic controlled trial to prevent childhood obesity within a risk group at maternity and child health-care clinics: results up to six years of age (the VACOPP study).

    Science.gov (United States)

    Mustila, Taina; Raitanen, Jani; Keskinen, Päivi; Luoto, Riitta

    2018-02-27

    Obesity in childhood appears often during the toddler years. The prenatal environment influences obesity risk. Maternal gestational diabetes, the child's diet, and physical activity in the first few years have an important role in subsequent weight gain. A study was conducted to evaluate effectiveness of a primary health-care lifestyle counselling intervention in prevention of childhood obesity up to 6 years of age. The study was a controlled pragmatic trial to prevent childhood obesity and was implemented at maternity and child health-care clinics. The participants (n = 185) were mothers at risk of gestational diabetes mellitus with their offspring born between 2008 and 2010. The prenatal intervention, started at the end of the first trimester of pregnancy, consisted of counselling on diet and physical activity by municipal health-care staff. The intervention continued at yearly appointments with a public health-nurse at child health-care clinics. The paper reports the offspring weight gain results for 2-6 years of age. Weight gain up to 6 years of age was assessed as BMI standard deviation scores (SDS) via a mixed-effect linear regression model. The proportion of children at 6 years with overweight/obesity was assessed as weight-for-height percentage and ISO-BMI. Priority was not given to power calculations, because of the study's pragmatic nature. One hundred forty seven children's (control n = 76/85% and intervention n = 71/56%) weight and height scores were available for analysis at 6 years of age. There was no significant difference in weight gain or overweight/obesity proportions between the groups at 6 years of age, but the proportion of children with obesity in both groups was high (assessed as ISO-BMI 9.9% and 11.8%) relative to prevalence in this age group in Finland. As the authors previously reported, the intervention-group mothers had lower prevalence of gestational diabetes mellitus, but a decrease in obesity incidence before school age

  1. The Impact of Achieve3000 on Elementary Literacy Outcomes: Evidence from a Two-Year Randomized Control Trial

    Science.gov (United States)

    Hill, Darryl V.; Lenard, Matthew A.; Page, Lindsay Coleman

    2016-01-01

    School districts are increasingly adopting technology-based resources in an attempt to improve student achievement. This paper reports the two-year results from randomized control trial of Achieve3000 in the Wake County Public School System (WCPSS) in Raleigh, North Carolina. Achieve3000 is an early literacy program that differentiates non-fiction…

  2. Heterogeneity in recent-onset type 1 diabetes - a clinical trial perspective.

    Science.gov (United States)

    Bollyky, Jennifer B; Xu, Ping; Butte, Atul J; Wilson, Darrell M; Beam, Craig A; Greenbaum, Carla J

    2015-09-01

    Type 1 diabetes (T1D) TrialNet is a National Institutes of Health-sponsored clinical trial network aimed at altering the disease course of T1D. The purpose of this study is to evaluate age-dependent heterogeneity in clinical, metabolic and immunologic characteristics of individuals with recent-onset T1D, to identify cohorts of interest and to aid in planning of future studies. Eight hundred eighty-three individuals with recent-onset T1D involved in five TrialNet studies were categorized by age as follows: ≥18 years, 12-17 years, 8-12 years and TrialNet studies, including C-peptide >0.2 pmol/mL, varies by age. Lower C-peptide level requirements for younger participants and other aspects of heterogeneity of recent-onset T1D patients, such as white blood cell count abnormalities and body mass index should be considered in the design of future clinical studies. Copyright © 2015 John Wiley & Sons, Ltd.

  3. Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions.

    Directory of Open Access Journals (Sweden)

    Stephanie Coronado-Montoya

    Full Text Available A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified.CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses.108 (87% of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88% concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7. Of 21 trial registrations, 13 (62% remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases.The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice.

  4. Low-fat dietary pattern and weight change over 7 years: the Women's Health Initiative Dietary Modification Trial.

    Science.gov (United States)

    Howard, Barbara V; Manson, JoAnn E; Stefanick, Marcia L; Beresford, Shirley A; Frank, Gail; Jones, Bobette; Rodabough, Rebecca J; Snetselaar, Linda; Thomson, Cynthia; Tinker, Lesley; Vitolins, Mara; Prentice, Ross

    2006-01-04

    Obesity in the United States has increased dramatically during the past several decades. There is debate about optimum calorie balance for prevention of weight gain, and proponents of some low-carbohydrate diet regimens have suggested that the increasing obesity may be attributed, in part, to low-fat, high-carbohydrate diets. To report data on body weight in a long-term, low-fat diet trial for which the primary end points were breast and colorectal cancer and to examine the relationships between weight changes and changes in dietary components. Randomized intervention trial of 48,835 postmenopausal women in the United States who were of diverse backgrounds and ethnicities and participated in the Women's Health Initiative Dietary Modification Trial; 40% (19,541) were randomized to the intervention and 60% (29,294) to a control group. Study enrollment was between 1993 and 1998, and this analysis includes a mean follow-up of 7.5 years (through August 31, 2004). The intervention included group and individual sessions to promote a decrease in fat intake and increases in vegetable, fruit, and grain consumption and did not include weight loss or caloric restriction goals. The control group received diet-related education materials. Change in body weight from baseline to follow-up. Women in the intervention group lost weight in the first year (mean of 2.2 kg, Pfruit servings, and a nonsignificant trend toward weight loss occurred with increasing intake of fiber. A low-fat eating pattern does not result in weight gain in postmenopausal women. Clinical Trial Registration ClinicalTrials.gov, NCT00000611.

  5. Energy from biomass: Results of two-years trials on annual and perennial Herba ceous species

    International Nuclear Information System (INIS)

    Angelini, L.; Ceccarini, L.; Oggiano, N.; Bonari, E.

    1994-01-01

    In the framework of the PRisCa Project (Alternative Crops Research Project) a number of germ plasm collections were set up at the Department of Agronomy of the University of Pisa in order to identify annual and perennial herbaceous species utilizable for electric energy production. The first results deriving from trials carried out in 1992-93 are reported. The following species were used: 1) Annual: Sorghum bicolor, Hibiscus cannabinus, Pennisetum americanum, Kochia scoparia. 2) Perennial: Cynara cardunculus, Helianthus tuberosus, Miscantus sinensis, Arundo donax. Almost all species tested were represented by several genotypes. The total amount of species and genotype tested was 16. On all species, main phenological, biometric and productive determinations were performed. The hypothesized final use was intended to be electric power production by direct combustion and/or gasification. In addition, specific calorific value was also determined by adiabatic calorimeter as well as chemical composition of dry matter and ash composition. Species showing high yield potential, both from the quantitative and qualitative point of view, were Sorghum bicolor and Kochia scoparia (among annuals), as well as Miscanthus sinensis and Arundo donax (among perennials). Total dry matter yield ranged from about 23 tha -1 in the annual species to about 56 tha -1 in the perennials. The highest total calorific power obtainable from dry epigeic biomass was measured in Sorghum bicolor and Arundo donax - 4023 Kcal Kg -1 and 4166 Kcal Kg -1 respectively. The preliminary results suggest that vegetable biomass is environmentally-friendly and could contribute significantly to the world energy needs. (author)

  6. Maternal Fish Oil Supplementation in Pregnancy: A 12 Year Follow-Up of a Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Suzanne Meldrum

    2015-03-01

    Full Text Available A number of trials have been undertaken to assess whether the intake of omega-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA during pregnancy can influence the neurological development of the offspring, yet no consensus from these trials has been reached. We aimed to investigate the long-term effects (12 years of fish oil supplementation in pregnancy on neurodevelopment, including cognition, language and fine motor skills. In a follow up of a previously published randomised controlled trial of 98 pregnant women, their children were assessed at 12 years of age using a battery of neurodevelopmental assessments. Fifty participants were assessed at 12 years, with 25 participant’s mothers receiving fish oil supplementation, and 25 receiving control capsules. There were no significant differences for any of the assessment measures completed. Our data indicate that fish oil supplementation during pregnancy does not influence the cognition, language or fine motor skills of children in late primary school (12 years of age.

  7. Maternal fish oil supplementation in pregnancy: a 12 year follow-up of a randomised controlled trial.

    Science.gov (United States)

    Meldrum, Suzanne; Dunstan, Janet A; Foster, Jonathan K; Simmer, Karen; Prescott, Susan L

    2015-03-20

    A number of trials have been undertaken to assess whether the intake of omega-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA) during pregnancy can influence the neurological development of the offspring, yet no consensus from these trials has been reached. We aimed to investigate the long-term effects (12 years) of fish oil supplementation in pregnancy on neurodevelopment, including cognition, language and fine motor skills. In a follow up of a previously published randomised controlled trial of 98 pregnant women, their children were assessed at 12 years of age using a battery of neurodevelopmental assessments. Fifty participants were assessed at 12 years, with 25 participant's mothers receiving fish oil supplementation, and 25 receiving control capsules. There were no significant differences for any of the assessment measures completed. Our data indicate that fish oil supplementation during pregnancy does not influence the cognition, language or fine motor skills of children in late primary school (12 years of age).

  8. Home-based cardiac rehabilitation is as effective as centre-based cardiac rehabilitation among elderly with coronary heart disease: results from a randomised clinical trial

    DEFF Research Database (Denmark)

    Oerkild, Bodil; Frederiksen, Marianne; Hansen, Jorgen Fischer

    2011-01-01

    BACKGROUND: participation in centre-based cardiac rehabilitation (CR) is known to reduce morbidity and mortality but participation rates among the elderly are low. Establishing alternative programmes is important, and home-based CR is the predominant alternative. However, no studies have...... investigated the effect of home-based CR among a group of elderly patients with coronary heart disease with a long-term follow-up. METHODS: randomised clinical trial comparing home-based CR with comprehensive centre-based CR among patients = 65 years with coronary heart disease. RESULTS: seventy-five patients...... in the secondary outcomes of systolic blood pressure (-0.6 mmHg, 95% CI -11.3, 10.0), LDL cholesterol (0.3 mmol/l, 95% CI -0.04, 0.7), HDL cholesterol (0.2 mmol/l, 95% CI -0.01, 0.3), body composition, proportion of smokers and health-related quality of life. A group of patients who did not have an effect...

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

    Directory of Open Access Journals (Sweden)

    Veerus Piret

    2012-04-01

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

  10. Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

    Directory of Open Access Journals (Sweden)

    Rahu Mati

    2008-08-01

    Full Text Available Abstract Background Preventive drugs require long-term trials to show their effectiveness or harms and often a lot of changes occur during post-marketing studies. The purpose of this article is to describe the research process in a long-term randomized controlled trial and discuss the impact and consequences of changes in the research environment. Methods The Estonian Postmenopausal Hormone Therapy trial (EPHT, originally planned to continue for five years, was planned in co-operation with the Women's International Study of Long-Duration Oestrogen after Menopause (WISDOM in the UK. In addition to health outcomes, EPHT was specifically designed to study the impact of postmenopausal hormone therapy (HT on health services utilization. Results After EPHT recruited in 1999–2001 the Women's Health Initiative (WHI in the USA decided to stop the estrogen-progestin trial after a mean of 5.2 years in July 2002 because of increased risk of breast cancer and later in 2004 the estrogen-only trial because HT increased the risk of stroke, decreased the risk of hip fracture, and did not affect coronary heart disease incidence. WISDOM was halted in autumn 2002. These decisions had a major influence on EPHT. Conclusion Changes in Estonian society challenged EPHT to find a balance between the needs of achieving responses to the trial aims with a limited budget and simultaneously maintaining the safety of trial participants. Flexibility was the main key for success. Rapid changes are not limited only to transiting societies but are true also in developed countries and the risk must be included in planning all long-term trials. The role of ethical and data monitoring committees in situations with emerging new data from other studies needs specification. Longer funding for preventive trials and more flexibility in budgeting are mandatory. Who should prove the effectiveness of an (old drug for a new preventive indication? In preventive drug trials companies may

  11. Comparison of Environmental Attitudes and Experiences of Five-Year-Old Children Receiving Preschool Education in the Village and City Centre

    Science.gov (United States)

    Durkan, Nazmi; Güngör, Hande; Fetihi, Leyla; Erol, Ahmet; Gülay Ogelman, Hülya

    2016-01-01

    The purpose of the study is to compare environmental attitudes and experiences of five-year-old children receiving preschool education in the village and city centre. The first group comprised 54 five-year-old children who received preschool education and attended kindergartens of two primary schools in the Karateke and Kocabas villages of Honaz…

  12. Partial Breast Radiation Therapy With Proton Beam: 5-Year Results With Cosmetic Outcomes

    Energy Technology Data Exchange (ETDEWEB)

    Bush, David A., E-mail: dbush@llu.edu [Department of Radiation Oncology, Loma Linda University Medical Center, Loma Linda, California (United States); Do, Sharon [Department of Radiation Oncology, Loma Linda University Medical Center, Loma Linda, California (United States); Lum, Sharon; Garberoglio, Carlos [Department of Surgical Oncology, Loma Linda University Medical Center, Loma Linda, California (United States); Mirshahidi, Hamid [Department of Medical Oncology, Loma Linda University Medical Center, Loma Linda, California (United States); Patyal, Baldev; Grove, Roger; Slater, Jerry D. [Department of Radiation Oncology, Loma Linda University Medical Center, Loma Linda, California (United States)

    2014-11-01

    Purpose: We updated our previous report of a phase 2 trial using proton beam radiation therapy to deliver partial breast irradiation (PBI) in patients with early stage breast cancer. Methods and Materials: Eligible subjects had invasive nonlobular carcinoma with a maximal dimension of 3 cm. Patients underwent partial mastectomy with negative margins; axillary lymph nodes were negative on sampling. Subjects received postoperative proton beam radiation therapy to the surgical bed. The dose delivered was 40 Gy in 10 fractions, once daily over 2 weeks. Multiple fields were treated daily, and skin-sparing techniques were used. Following treatment, patients were evaluated with clinical assessments and annual mammograms to monitor toxicity, tumor recurrence, and cosmesis. Results: One hundred subjects were enrolled and treated. All patients completed the assigned treatment and were available for post-treatment analysis. The median follow-up was 60 months. Patients had a mean age of 63 years; 90% had ductal histology; the average tumor size was 1.3 cm. Actuarial data at 5 years included ipsilateral breast tumor recurrence-free survival of 97% (95% confidence interval: 100%-93%); disease-free survival of 94%; and overall survival of 95%. There were no cases of grade 3 or higher acute skin reactions, and late skin reactions included 7 cases of grade 1 telangiectasia. Patient- and physician-reported cosmesis was good to excellent in 90% of responses, was not changed from baseline measurements, and was well maintained throughout the entire 5-year follow-up period. Conclusions: Proton beam radiation therapy for PBI produced excellent ipsilateral breast recurrence-free survival with minimal toxicity. The treatment proved to be adaptable to all breast sizes and lumpectomy cavity configurations. Cosmetic results appear to be excellent and unchanged from baseline out to 5 years following treatment. Cosmetic results may be improved over those reported with photon

  13. Cost comparison of continued anticoagulation with rivaroxaban versus placebo based on the 1-year EINSTEIN-Extension trial efficacy and safety results.

    Science.gov (United States)

    Wells, Philip S; Lensing, Anthonie W A; Haskell, Lloyd; Levitan, Bennett; Laliberté, François; Durkin, Michael; Ashton, Veronica; Xiao, Yongling; Crivera, Concetta; Lejeune, Dominique; Schein, Jeff; Lefebvre, Patrick

    2018-06-01

    The EINSTEIN-Extension trial (EINSTEIN-EXT) found that continued treatment with rivaroxaban for an additional 6 or 12 months (vs placebo) after 6-12 months of initial anticoagulation significantly reduced the risk of recurrent venous thromboembolism (VTE) with a small non-significant increased risk of major bleeding (none fatal or in critical site). This study aimed to compare total healthcare cost between rivaroxaban and placebo, based on the EINSTEIN-EXT event rates. Total healthcare cost was calculated as the sum of treatment and clinical event costs from a US managed care perspective. Treatment duration and event rates were obtained from the EINSTEIN-EXT study. Adjustment on treatment duration was made by assuming a 10% non-adherence rate. Drug costs were based on wholesale acquisition costs. Cost estimates for clinical events (i.e. recurrent deep vein thrombosis [DVT], recurrent pulmonary embolism, major bleeding, clinically relevant non-major bleeding) were determined from the literature. Results were examined over a ±20% range of each cost component and over 95% confidence intervals (CIs) of event rate differences in deterministic (one-way) and probabilistic sensitivity analyses (PSA). Total healthcare cost was $1,454 lower for rivaroxaban-treated (vs placebo-treated) patients in the base-case, with a lower clinical event cost fully offsetting drug cost. The cost savings of recurrent DVT alone (-$3,102) was greater than drug cost ($2,723). Total healthcare cost remained lower for rivaroxaban in the majority (73%) of PSA (cost difference [95% CI] = -$1,454 [-$2,396, $1,231]). This study was conducted over the 1-year observation period of the EINSTEIN-EXT trial, which limited "real-world" applicability and examination of long-term economic impact. Assumptions on drug and clinical event costs were US-based and, thus, not applicable to other healthcare systems. Total healthcare costs were estimated to be lower for patients continuing rivaroxaban therapy

  14. The effects of radiation therapy on quality of life in women with breast cancer: Results of a randomized trial

    International Nuclear Information System (INIS)

    Whelan, T.; Levine, M.; Julian, J.; Skingley, P.; Kirkbride, P.; Clark, R.; Lipa, M.; Wilkinson, R.

    1997-01-01

    Purpose/Objective: The effects of radiation therapy on quality of life of women with breast cancer are not well known. The purpose of this study was to evaluate the effect of breast irradiation on quality of life including cosmetic outcome in the context of a randomized controlled trial. Methods: Between 1984 and 1989 a randomized trial was conducted in Ontario in which women with node-negative breast cancer who had undergone lumpectomy and axillary section were randomized either to postoperative radiation (4000 cGy in 16 fractions to the whole breast, followed by a boost of 1250 cGy in five fractions to the primary site) or no further treatment (J Natl Cancer Inst 1996; 88:1659). A modified version of the breast cancer chemotherapy questionnaire (J Clin Oncol 1988; 6:1798) containing 17 items was administered to women at baseline, one month and two months postrandomization. Each item was scored on a Likert scale from ''1'' All of the Time to ''7'' None of the Time. Patient assessments of breast pain and cosmetic outcome were also evaluated every three months for the first two years of the study. Results: Of 837 patients, 416 were randomly allocated to radiation therapy and 421 to no further treatment. The groups were comparable in terms of baseline characteristics. Factor analysis identified three different domains of the quality of life instrument: emotional/social, fatigue, and physical/inconvenience. There was a significant difference in the physical/inconvenience and fatigue domain scores between the radiation and control groups over time. The differences in scores between groups at two months post randomization were 0.97, p = 0.0001; 0.33, p=0.0001; and 0.03, p=0.62 for the physical/inconvenience, fatigue and emotional/social domains respectively. The percentage of patients who were troubled by breast pain differed between radiation and control groups up to one year (33.3% vs 19.9%, p = 0.001 at 6 months). Beyond one year, no difference was detected. The

  15. Reduced Cardiovascular Mortality 10 Years after Supplementation with Selenium and Coenzyme Q10 for Four Years: Follow-Up Results of a Prospective Randomized Double-Blind Placebo-Controlled Trial in Elderly Citizens.

    Directory of Open Access Journals (Sweden)

    Urban Alehagen

    Full Text Available Selenium and coenzyme Q10 are important antioxidants in the body. As the intake of selenium is low in Europe, and the endogenous production of coenzyme Q10 decreases as age increases, an intervention trial using selenium and coenzyme Q10 for four years was performed. As previously reported, the intervention was accompanied by reduced cardiovascular mortality. The objective of the present study was to analyze cardiovascular mortality for up to 10 years after intervention, to evaluate if mortality differed in subgroups differentiated by gender, diabetes, ischemic heart disease (IHD, and functional class.Four-hundred forty-three healthy elderly individuals were included from a rural municipality in Sweden. All cardiovascular mortality was registered, and no participant was lost to the follow-up. Based on death certificates and autopsy results mortality was registered.Significantly reduced cardiovascular mortality could be seen in those on selenium and coenzyme Q10 intervention. A multivariate Cox regression analysis demonstrated a reduced cardiovascular mortality risk in the active treatment group (HR: 0.51; 95%CI 0.36-0.74; P = 0.0003. The reduced mortality could be seen to persist during the 10-year period. Subgroup analysis showed positive effects in both genders. An equally positive risk reduction could be seen in those with ischemic heart disease (HR: 0.51; 95%CI 0.27-0.97; P = 0.04, but also in the different functional classes.In a 10-year follow-up of a group of healthy elderly participants given four years of intervention with selenium and coenzyme Q10, significantly reduced cardiovascular mortality was observed. The protective action was not confined to the intervention period, but persisted during the follow-up period. The mechanism explaining the persistency remains to be elucidated. Since this was a small study, the observations should be regarded as hypothesis-generating.

  16. North Dakota University System Five-Year Plan. Daring to Be Great: The NDUS Edge

    Science.gov (United States)

    North Dakota University System, 2017

    2017-01-01

    This report presents the 2017-19 edition of the State Board of Higher Education's strategic narrative. Contents include: (1) North Dakota University System (NDUS) colleges and locations; (2) Board Chair Neset's report; (3) Five-year goals; (4) Deliver degrees that are the best value in the nation; (5) Provide programs people want; (6) Equip…

  17. Anisotropies in the cosmic neutrino background after Wilkinson Microwave Anisotropy Probe five-year data

    International Nuclear Information System (INIS)

    De Bernardis, Francesco; Pagano, Luca; Melchiorri, Alessandro; Serra, Paolo; Cooray, Asantha

    2008-01-01

    We search for the presence of cosmological neutrino background (CNB) anisotropies in recent Wilkinson Microwave Anisotropy Probe (WMAP) five-year data using their signature imprinted on modifications to the cosmic microwave background (CMB) anisotropy power spectrum. By parameterizing the neutrino background anisotropies with the speed viscosity parameter c vis , we find that the WMAP five-year data alone provide only a weak indication for CNB anisotropies with c vis 2 >0.06 at the 95% confidence level. When we combine CMB anisotropy data with measurements of galaxy clustering, the SN-Ia Hubble diagram, and other cosmological information, the detection increases to c vis 2 >0.16 at the same 95% confidence level. Future data from Planck, combined with a weak lensing survey such as the one expected with DUNE from space, will be able to measure the CNB anisotropy parameter at about 10% accuracy. We discuss the degeneracy between neutrino background anisotropies and other cosmological parameters such as the number of effective neutrinos species and the dark energy equation of state

  18. A Retrospective Analysis of the Results of a Five-Year (2005?2009) Parasitological Examination for Common Intestinal Parasites from Bale-Robe Health Center, Robe Town, Southeastern Ethiopia

    OpenAIRE

    Chala, Bayissa

    2013-01-01

    A cross-sectional retrospective survey using the past five years clinical records (2005?2009) was conducted. The study was aimed at assessing the status of common intestinal parasites from Bale-Robe Health Center, Southeastern Ethiopia, in 2009/2010. The survey involved collection of data recorded on intestinal parasite from the health center during 2005?2009. Precoded questionnaires and interviews were also supplemented for knowledge attitude practices survey (KAPs survey) to assess awarenes...

  19. 78 FR 13380 - Silicomanganese From India, Kazakhstan, and Venezuela; Scheduling of Full Five-Year Reviews...

    Science.gov (United States)

    2013-02-27

    ... From India, Kazakhstan, and Venezuela; Scheduling of Full Five-Year Reviews Concerning the Antidumping Duty Orders on Silicomanganese From India, Kazakhstan, and Venezuela AGENCY: United States..., Kazakhstan, and Venezuela would be likely to lead to continuation or recurrence of material injury within a...

  20. Phase 2 clinical trial of a recombinant adeno-associated viral vector expressing α1-antitrypsin: interim results.

    LENUS (Irish Health Repository)

    Flotte, Terence R

    2011-10-01

    Recombinant adeno-associated virus (rAAV) vectors offer promise for the gene therapy of α(1)-antitrypsin (AAT) deficiency. In our prior trial, an rAAV vector expressing human AAT (rAAV1-CB-hAAT) provided sustained, vector-derived AAT expression for >1 year. In the current phase 2 clinical trial, this same vector, produced by a herpes simplex virus complementation method, was administered to nine AAT-deficient individuals by intramuscular injection at doses of 6.0×10(11), 1.9×10(12), and 6.0×10(12) vector genomes\\/kg (n=3 subjects\\/dose). Vector-derived expression of normal (M-type) AAT in serum was dose dependent, peaked on day 30, and persisted for at least 90 days. Vector administration was well tolerated, with only mild injection site reactions and no serious adverse events. Serum creatine kinase was transiently elevated on day 30 in five of six subjects in the two higher dose groups and normalized by day 45. As expected, all subjects developed anti-AAV antibodies and interferon-γ enzyme-linked immunospot responses to AAV peptides, and no subjects developed antibodies to AAT. One subject in the mid-dose group developed T cell responses to a single AAT peptide unassociated with any clinical effects. Muscle biopsies obtained on day 90 showed strong immunostaining for AAT and moderate to marked inflammatory cell infiltrates composed primarily of CD3-reactive T lymphocytes that were primarily of the CD8(+) subtype. These results support the feasibility and safety of AAV gene therapy for AAT deficiency, and indicate that serum levels of vector-derived normal human AAT >20 μg\\/ml can be achieved. However, further improvements in the design or delivery of rAAV-AAT vectors will be required to achieve therapeutic target serum AAT concentrations.