WorldWideScience

Sample records for premier trial population

  1. Premier Hospital Historical Data

    Data.gov (United States)

    U.S. Department of Health & Human Services — To provide a historical overview of the participating hospitals, before the first project report, Premier Healthcare Informatics has used data already available for...

  2. A gender-sensitised weight loss and healthy living programme for overweight and obese men delivered by Scottish Premier League football clubs (FFIT): a pragmatic randomised controlled trial.

    Science.gov (United States)

    Hunt, Kate; Wyke, Sally; Gray, Cindy M; Anderson, Annie S; Brady, Adrian; Bunn, Christopher; Donnan, Peter T; Fenwick, Elisabeth; Grieve, Eleanor; Leishman, Jim; Miller, Euan; Mutrie, Nanette; Rauchhaus, Petra; White, Alan; Treweek, Shaun

    2014-04-05

    The prevalence of male obesity is increasing but few men take part in weight loss programmes. We assessed the effect of a weight loss and healthy living programme on weight loss in football (soccer) fans. We did a two-group, pragmatic, randomised controlled trial of 747 male football fans aged 35-65 years with a body-mass index (BMI) of 28 kg/m(2) or higher from 13 Scottish professional football clubs. Participants were randomly assigned with SAS (version 9·2, block size 2-9) in a 1:1 ratio, stratified by club, to a weight loss programme delivered by community coaching staff in 12 sessions held every week. The intervention group started a weight loss programme within 3 weeks, and the comparison group were put on a 12 month waiting list. All participants received a weight management booklet. Primary outcome was mean difference in weight loss between groups at 12 months, expressed as absolute weight and a percentage of their baseline weight. Primary outcome assessment was masked. Analyses were based on intention to treat. The trial is registered with Current Controlled Trials, number ISRCTN32677491. 374 men were allocated to the intervention group and 374 to the comparison group. 333 (89%) of the intervention group and 355 (95%) of the comparison group completed 12 month assessments. At 12 months the mean difference in weight loss between groups, adjusted for baseline weight and club, was 4·94 kg (95% CI 3·95-5·94) and percentage weight loss, similarly adjusted, was 4·36% (3·64-5·08), both in favour of the intervention (pScottish Government and The UK Football Pools funded delivery of the programme through a grant to the Scottish Premier League Trust. The National Institute for Health Research Public Health Research Programme funded the assessment (09/3010/06). Copyright © 2014 Hunt et al. Open Access article distributed under the terms of CC BY-NC-ND. Published by Elsevier Ltd. All rights reserved.

  3. Premier's imaging IR limb sounder

    Science.gov (United States)

    Kraft, Stefan; Bézy, Jean-Loup; Meynart, Roland; Langen, Jörg; Carnicero Dominguez, Bernardo; Bensi, Paolo; Silvestrin, Pierluigi

    2017-11-01

    The Imaging IR Limb Sounder (IRLS) is one of the two instruments planned on board of the candidate Earth Explorer Core Mission PREMIER. PREMIER stands for PRocess Exploration through Measurements of Infrared and Millimetre-wave Emitted Radiation. PREMIER went recently through the process of a feasibility study (Phase A) within the Earth Observation Envelope Program. Emerging from recent advanced instrument technologies IRLS shall, next to a millimetre-wave limb sounder (called STEAMR), explore the benefits of three-dimensional limb sounding with embedded cloud imaging capability. Such 3D imaging technology is expected to open a new era of limb sounding that will allow detailed studies of the link between atmospheric composition and climate, since it will map simultaneously fields of temperature and many trace gases in the mid/upper troposphere and stratosphere across a large vertical and horizontal field of view and with high vertical and horizontal resolution. PREMIER shall fly in a tandem formation looking backwards to METOP's swath and thereby improve meteorological and environmental analyses.

  4. A gender-sensitised weight loss and healthy living programme for overweight and obese men delivered by Scottish Premier League football clubs (FFIT): a pragmatic randomised controlled trial

    Science.gov (United States)

    Hunt, Kate; Wyke, Sally; Gray, Cindy M; Anderson, Annie S; Brady, Adrian; Bunn, Christopher; Donnan, Peter T; Fenwick, Elisabeth; Grieve, Eleanor; Leishman, Jim; Miller, Euan; Mutrie, Nanette; Rauchhaus, Petra; White, Alan; Treweek, Shaun

    2015-01-01

    Summary Background The prevalence of male obesity is increasing but few men take part in weight loss programmes. We assessed the effect of a weight loss and healthy living programme on weight loss in football (soccer) fans. Methods We did a two-group, pragmatic, randomised controlled trial of 747 male football fans aged 35–65 years with a body-mass index (BMI) of 28 kg/m2 or higher from 13 Scottish professional football clubs. Participants were randomly assigned with SAS (version 9·2, block size 2–9) in a 1:1 ratio, stratified by club, to a weight loss programme delivered by community coaching staff in 12 sessions held every week. The intervention group started a weight loss programme within 3 weeks, and the comparison group were put on a 12 month waiting list. All participants received a weight management booklet. Primary outcome was mean difference in weight loss between groups at 12 months, expressed as absolute weight and a percentage of their baseline weight. Primary outcome assessment was masked. Analyses were based on intention to treat. The trial is registered with Current Controlled Trials, number ISRCTN32677491. Findings 374 men were allocated to the intervention group and 374 to the comparison group. 333 (89%) of the intervention group and 355 (95%) of the comparison group completed 12 month assessments. At 12 months the mean difference in weight loss between groups, adjusted for baseline weight and club, was 4·94 kg (95% CI 3·95–5·94) and percentage weight loss, similarly adjusted, was 4·36% (3·64–5·08), both in favour of the intervention (p<0·0001). Eight serious adverse events were reported, five in the intervention group (lost consciousness due to drugs for pre-existing angina, gallbladder removal, hospital admission with suspected heart attack, ruptured gut, and ruptured Achilles tendon) and three in the comparison group (transient ischaemic attack, and two deaths). Of these, two adverse events were reported as related to

  5. The challenge and impact of engaging hard-to-reach populations in regular physical activity and health behaviours: an examination of an English Premier League 'Football in the Community' men's health programme.

    Science.gov (United States)

    Curran, K; Drust, B; Murphy, R; Pringle, A; Richardson, D

    2016-06-01

    To investigate the challenges that men from hard-to-reach (HTR) populations encounter when attempting to commit to regular participation in physical activity and health behaviours, and to explore the psychological and social effects of participation in a twelve week football-led health improvement intervention. A twelve week football specific physical activity intervention targeting men from HTR populations was delivered by Everton Football Clubs' Football in the Community (FitC) scheme as part of a national programme of men's health delivered in/by English Premier League (EPL) football clubs. Men living in homeless shelters and/or recovering from substance misuse were recruited over a period of three months. The programme consisted of a two hour football session, twice weekly, alongside the dissemination of healthy living messages. Football sessions were conducted by a qualified FitC coach. This research was conducted during a twelve week period of immersed practitioner-research. Ethnographic and observational methodologies were adopted. Psychosocial issues were discussed with participants through informal client-researcher interactions and data were logged via field notes. Records of attendance were logged. Participants who failed to attend a session were contacted and their reason(s) for non-attendance were recorded. Data were analysed using deductive and inductive reasoning. Despite the apparent ambition of the participants to regularly participate in the FitC programme, adherence to the programme was poor. Economic, environmental and social barriers to engagement in the programme were apparent. Engagement in the programme resulted in positive psychosocial developments; the development of structure, social interaction and social capital. Community based football-led health improvement programmes endorsed by professional football clubs appear well positioned to connect with, and attract, men from HTR populations. The evidence suggests that such programmes can

  6. Mastering Adobe Premiere Pro CS6

    CERN Document Server

    Ekert, Paul

    2013-01-01

    Designed to be practical and engaging, Mastering Adobe Premiere Pro CS6 is a project-based book to help you truly augment your skills and become a film editing hotshot.If you're just starting out or even migrating from existing video editing software, then this book is for you. With rapid progression through practical examples constructed to be both engaging and useful, Mastering Adobe Premiere Pro CS6 is ideal for learning the sometimes complex workflows of this powerful application.

  7. Generalizing Evidence From Randomized Clinical Trials to Target Populations

    Science.gov (United States)

    Cole, Stephen R.; Stuart, Elizabeth A.

    2010-01-01

    Properly planned and conducted randomized clinical trials remain susceptible to a lack of external validity. The authors illustrate a model-based method to standardize observed trial results to a specified target population using a seminal human immunodeficiency virus (HIV) treatment trial, and they provide Monte Carlo simulation evidence supporting the method. The example trial enrolled 1,156 HIV-infected adult men and women in the United States in 1996, randomly assigned 577 to a highly active antiretroviral therapy and 579 to a largely ineffective combination therapy, and followed participants for 52 weeks. The target population was US people infected with HIV in 2006, as estimated by the Centers for Disease Control and Prevention. Results from the trial apply, albeit muted by 12%, to the target population, under the assumption that the authors have measured and correctly modeled the determinants of selection that reflect heterogeneity in the treatment effect. In simulations with a heterogeneous treatment effect, a conventional intent-to-treat estimate was biased with poor confidence limit coverage, but the proposed estimate was largely unbiased with appropriate confidence limit coverage. The proposed method standardizes observed trial results to a specified target population and thereby provides information regarding the generalizability of trial results. PMID:20547574

  8. Scottish Premier League Reading Stars Evaluation Report

    Science.gov (United States)

    National Literacy Trust, 2009

    2009-01-01

    Scottish Premier League (SPL) Reading Stars uses the motivational power of football to attract families who need support with literacy into a positive and friendly learning environment. It ran for the first time between March and August 2009 and attracted 225 children and 190 adults to take part in a series of inspirational learning sessions in 23…

  9. Premier Wen hails sci-tech cooperation with CERN

    CERN Multimedia

    2004-01-01

    Premier Wen Jiabao met CERN's director general Dr Robert Aymar and physicist and Nobel laureate Dr Samuel Chao Chung Ting. Premier Wen emphasied the importance for China to collaborate on fundamental science (0.5 page)

  10. METHODOLOGICAL ISSUES OF CLINICAL TRIALS IN THE PEDIATRIC POPULATION

    Directory of Open Access Journals (Sweden)

    S.V. Topolyanskaya

    2010-01-01

    Full Text Available Conducting clinical trials on children population is a challenge both for organizers and pediatricians involved in trials. Difficulties in recruiting patients, a significant heterogenecity of the population, specific side reactions, difficulties in identifying the objective final points warrant the specific nature of designing clinical trials in pediatrics. The article illustrates key issues and methodology aspects: planning, design, control groups, patient recruitment. It stresses the need to carefully consider specific characteristics of a child’s system and multi-disciplinary approach involving a pediatrician at the early stages of planning, preliminary consultations with parent organizations, children and regulators.Key words: clinical trials, methodology, planning, design, patient recruitment, children. (Pediatric Pharmacology. – 2010; 7(5:6-10

  11. [Population Council responsible for RU486 clinical trials in USA].

    Science.gov (United States)

    Aguillaume, C J

    1993-04-01

    As a result of the sudden political change that came with the Clinton Administration, RU-486's manufacturer, Roussel-Uclaf, and the Population Council agreed on April 20, 1992, on the manufacture and distribution of RU-486 in the US. In the US, there are less than 1.6 million induced abortions annually. From now on, US women will be able to have a choice between medical and surgical abortion. The Population Council and Roussel-Uclaf have had a contract since 1982. The Council is solely responsible for the phase 2 clinical trial of RU-486 in the US and other countries. It must present to the US Food and Drug Administration (FDA) an amendment allowing it to begin phase 3 clinical trials. The Council will also lead the US medical facilities in this study. It will identify partners for future production of RU-486 and its distribution in the US. It will also submit to FDA a New Drug Application (NDA). FDA will review the scientific literature on RU-486 and evaluate all data submitted by the Population Council. There are still obstacles to be surmounted. The Population Council must demonstrate good judgment when selecting the criteria for choosing a pharmaceutical firm before a Technical Committee which will be part of a group of players promoting women's health, scientific experts, and other interested parties. It must find the necessary funds to conduct the clinical trials and prepare the NDA. Phase 3 clinical trials in the US must have at least 2000 women. They will test RU-486's efficacy, safety, and acceptability among women choosing medical abortion over surgical abortion. Since the Council operates in almost all countries in the world, has innovated contraceptive research and development activities, and has been endorsed by the UN, product approval of RU-486 in the US will affect policy in all countries concerned about abortion.

  12. Management and marketing of sporting events: Nike Premier Cup Project

    OpenAIRE

    Nedbal, Jakub

    2008-01-01

    Title: Management and marketing ofsporting events: Nike Premier Cup project Points of thesis: Publish the Nike Premier Cup promotion campaign project and point out improvement possibilities for upcoming years based on analysis ofpast and present state. Methods: Data will be obtained by interview, observation, description analysis and SWOT analysis Results: Promotion campaign, improvement possibilities, final day schedule Keywords: SWOT analysis, promotion, management, marketing, Nike Premier ...

  13. A Population-Based Clinical Trial of Irinotecan and Carboplatin

    Directory of Open Access Journals (Sweden)

    Derick Lau

    2009-01-01

    Full Text Available Purpose. Phase I trials of anticancer drugs are commonly conducted using the method of modified Fibonacci. We have developed a population-based design for phase I trials of combining anticancer drugs such as irinotecan and carboplatin. Patients and Methods. Intrapatient dose escalation of irinotecan and carboplatin was performed according to a predetermined schema to reach individual dose-limiting toxicity (DLT in 50 patients with solid tumors refractory to previous chemotherapy. The individual toxicity-limiting dose levels were analyzed for normal distribution using the method of Ryan-Joiner and subsequently used to determine a population-based maximum tolerated dose (pMTD. For comparison, a simulation study was performed using the method of modified Fibonacci. Results. The most common dose-limiting toxicities (DLTs included neutropenia (58%, thrombocytopenia (16%, and diarrhea (8%. The frequency of individual toxicity-limiting dose levels of 50 patients approximated a normal distribution. The dose levels associated with individual limiting toxicities ranged from level 1 (irinotecan 100 mg/m2 and carboplatin AUC = 4 mg/mL x min to level 8 (irinotecan 350 mg/m2 and carboplatin AUC = 6. The pMTD was determined to be dose level 3 (150 mg/m2 for irinotecan and AUC = 5 for carboplatin. In contrast, the MTD was determined to be dose level 4 (200 mg/m2 for irinotecan and AUC 5 for carboplatin by modified-Fibonacci simulation. Conclusions. The population-based design of phase I trial allows optimization of dose intensity and derivation of a pMTD. The pMTD has been applied in phase II trial of irinotecan and carboplatin in patients with small-cell lung cancer.

  14. Black Generation Y gender differences in Premier Soccer League spectator motives : sport marketing

    OpenAIRE

    T.E. Mofokeng; A.L. Bevan-Dye

    2014-01-01

    The purpose of this study was to determine whether there are gender differences concerning Premier Soccer League (PSL) spectator motives amongst black Generation Y students in South Africa. In South Africa, the black Generation Y cohort (individuals born between 1986 and 2005) represents an important but under-researched market segment in that, in 2013, they made up 32 percent of the country's population. From a PSL marketing perspective, understanding the motives that drive game spectatorshi...

  15. The COLOFOL trial: study design and comparison of the study population with the source cancer population

    Directory of Open Access Journals (Sweden)

    Hansdotter Andersson P

    2016-01-01

    Full Text Available Pernilla Hansdotter Andersson,1 Peer Wille-Jørgensen,2 Erzsébet Horváth-Puhó,3 Sune Høirup Petersen,2 Anna Martling,4 Henrik Toft Sørensen,3 Ingvar Syk1 On behalf of the COLOFOL Study Group 1Department of Surgery, Skåne University Hospital, Malmö, Sweden; 2Abdominal Disease Center K, Bispebjerg University Hospital, Copenhagen, Denmark; 3Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 4Department of Molecular Medicine and Surgery, Karolinska Institutet, Solna, Sweden Introduction: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL trial, comparing demographic characteristics between randomized patients and eligible patients not included in the study. Materials and methods: COLOFOL was designed as a pragmatic trial with wide inclusion criteria and few exclusion criteria, in order to obtain a sample reflecting the general patient population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24 participating centers, we scrutinized hospital inpatient data to identify all colorectal cancer patients who underwent surgery, in order to ascertain all eligible patients who were not included in the study and to compare them with enrolled patients. Results: Of a total of 4,445 eligible patients, 2,509 patients were randomized (56.4% inclusion rate. A total of 1,221 eligible patients were identified in the scrutinized hospitals, of which 684 (56% were randomized. No difference in age or sex distribution was observed between randomized and nonrandomized

  16. Echographie devant une metrorragie du premier trimestre de ...

    African Journals Online (AJOL)

    Echographie devant une metrorragie du premier trimestre de grossesse sur uterus bicorne a issue favorable. Vaginal bleeding in a pregnant woman with a bicornuate uterus, ultrasound finding and favourable outcome.

  17. Policy Advice to Alberta’s New Premier

    Directory of Open Access Journals (Sweden)

    Jack M. Mintz

    2014-09-01

    Full Text Available On September 6th, 2014, members of the Progressive Conservative Party of Alberta elected Jim Prentice as leader of their party, and Premier of Alberta. The School of Public Policy assembled its key thinkers in economic, taxation, energy and natural resource policy to provide unsolicited but important advice to Premier Prentice on some areas of policy that matter most to Alberta, and that will demand the Premier’s attention as he takes office. These are opinion pieces, are not peer reviewed, and reflect the views of their authors alone.

  18. The Role of Internet in Marketing Premiering Movies

    OpenAIRE

    Tuohimaa, Suvi

    2010-01-01

    The objective of this thesis was to find out about the role of Internet today in premiering movie marketing and whether Internet is a good tool for it. The hope was to obtain new information provided by moviegoers and to contribute something useful to the art of marketing premiering movies. This thesis was a part of the School of Business and Information Management's Innomajakka-project but did not have an official commissioner, so the topic for the thesis came from the writer's personal and ...

  19. Automated classification of eligibility criteria in clinical trials to facilitate patient-trial matching for specific patient populations.

    Science.gov (United States)

    Zhang, Kevin; Demner-Fushman, Dina

    2017-07-01

    To develop automated classification methods for eligibility criteria in ClinicalTrials.gov to facilitate patient-trial matching for specific populations such as persons living with HIV or pregnant women. We annotated 891 interventional cancer trials from ClinicalTrials.gov based on their eligibility for human immunodeficiency virus (HIV)-positive patients using their eligibility criteria. These annotations were used to develop classifiers based on regular expressions and machine learning (ML). After evaluating classification of cancer trials for eligibility of HIV-positive patients, we sought to evaluate the generalizability of our approach to more general diseases and conditions. We annotated the eligibility criteria for 1570 of the most recent interventional trials from ClinicalTrials.gov for HIV-positive and pregnancy eligibility, and the classifiers were retrained and reevaluated using these data. On the cancer-HIV dataset, the baseline regex model, the bag-of-words ML classifier, and the ML classifier with named entity recognition (NER) achieved macro-averaged F2 scores of 0.77, 0.87, and 0.87, respectively; the addition of NER did not result in a significant performance improvement. On the general dataset, ML + NER achieved macro-averaged F2 scores of 0.91 and 0.85 for HIV and pregnancy, respectively. The eligibility status of specific patient populations, such as persons living with HIV and pregnant women, for clinical trials is of interest to both patients and clinicians. We show that it is feasible to develop a high-performing, automated trial classification system for eligibility status that can be integrated into consumer-facing search engines as well as patient-trial matching systems. Published by Oxford University Press on behalf of the American Medical Informatics Association 2017. This work is written by US Government employees and is in the public domain in the US.

  20. Open Access Publishing in Indian Premier Research Institutions

    Science.gov (United States)

    Bhat, Mohammad Hanief

    2009-01-01

    Introduction: Publishing research findings in open access journals is a means of enhancing visibility and consequently increasing the impact of publications. This study provides an overview of open access publishing in premier research institutes of India. Method: The publication output of each institution from 2003 to 2007 was ascertained through…

  1. Trichoberoard gastrique : Premier cas observe en milieu bur kina be ...

    African Journals Online (AJOL)

    Le trichobezoard est une concretion de cheveux, de poils ou de fibres de tapis et de debris alimentaire, localisee habituellement dans l'estomac. Le trichobezoard est une pathologie rare qui survient habituellement chez des adolescentes presentant des troubles psychiques. La premiere observation de trichobezoard a ete ...

  2. Physiological response of one of South Africa's premier freshwater ...

    African Journals Online (AJOL)

    Physiological response of one of South Africa's premier freshwater sport angling species, the Orange-Vaal smallmouth yellowfish Labeobarbus aeneus, ... These data suggest that catch-and-release causes physiological stress to fish, but nonetheless this practice can be a valuable fisheries management tool to ensure the ...

  3. Premiere toob lavale jalgpallimeeskonna, inimkatsed ja punase tooli / Kairi Prints

    Index Scriptorium Estoniae

    Prints, Kairi, 1977-

    2012-01-01

    Premiere 2012 osalevad neli Eesti tantsukunstnikku: Svetlana Grigorjeva tantsulavastusega "sõp rus est", Kaisa Selde, Kristina-Maria Heinsalu ja Christin Lunts tantsulavastusega "fie", esmakordselt võtab osa välismaalane - sakslanna Mareike Franz tantsulavastusega "Duett". Kõik esietenduvad 9. veebruaril Kanuti gildi saalis

  4. Computers for Schools Kenya se classe au premier rang | CRDI ...

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

    Cinq ans après avoir remis en service ses premiers ordinateurs recyclés et leur avoir trouvé un nouveau nid, l'organisation non gouvernementale Computers for Schools Kenya (CFSK) s'est mérité un prix convoité à l'échelle de l'Afrique pour son travail.

  5. Directions for new developments on statistical design and analysis of small population group trials.

    Science.gov (United States)

    Hilgers, Ralf-Dieter; Roes, Kit; Stallard, Nigel

    2016-06-14

    Most statistical design and analysis methods for clinical trials have been developed and evaluated where at least several hundreds of patients could be recruited. These methods may not be suitable to evaluate therapies if the sample size is unavoidably small, which is usually termed by small populations. The specific sample size cut off, where the standard methods fail, needs to be investigated. In this paper, the authors present their view on new developments for design and analysis of clinical trials in small population groups, where conventional statistical methods may be inappropriate, e.g., because of lack of power or poor adherence to asymptotic approximations due to sample size restrictions. Following the EMA/CHMP guideline on clinical trials in small populations, we consider directions for new developments in the area of statistical methodology for design and analysis of small population clinical trials. We relate the findings to the research activities of three projects, Asterix, IDeAl, and InSPiRe, which have received funding since 2013 within the FP7-HEALTH-2013-INNOVATION-1 framework of the EU. As not all aspects of the wide research area of small population clinical trials can be addressed, we focus on areas where we feel advances are needed and feasible. The general framework of the EMA/CHMP guideline on small population clinical trials stimulates a number of research areas. These serve as the basis for the three projects, Asterix, IDeAl, and InSPiRe, which use various approaches to develop new statistical methodology for design and analysis of small population clinical trials. Small population clinical trials refer to trials with a limited number of patients. Small populations may result form rare diseases or specific subtypes of more common diseases. New statistical methodology needs to be tailored to these specific situations. The main results from the three projects will constitute a useful toolbox for improved design and analysis of small

  6. Improving ethical and participatory practice for marginalized populations in biomedical HIV prevention trials: lessons from Thailand.

    Directory of Open Access Journals (Sweden)

    Dan Allman

    Full Text Available BACKGROUND: This paper presents findings from a qualitative investigation of ethical and participatory issues related to the conduct of biomedical HIV prevention trials among marginalized populations in Thailand. This research was deemed important to conduct, as several large-scale biomedical HIV prevention trials among marginalized populations had closed prematurely in other countries, and a better understanding of how to prevent similar trial closures from occurring in the future was desired. METHODS: In-depth key informant interviews were held in Bangkok and Chiang Mai, Thailand. Interviews were audio recorded, transcribed, translated and thematically analyzed. The Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials (GPP guided this work. RESULTS: Fourteen interviews were conducted: 10 with policymakers, academic and community-based researchers and trial staff and four with representatives of non-governmental organizations (NGOs. Suggested ways to improve ethical and participatory practice centered on standards of HIV prevention, informed consent, communication and human rights. In particular, the need to overcome language and literacy differences was identified. Key informants felt communication was the basis of ethical understanding and trust within biomedical HIV prevention trial contexts, and thus fundamental to trial participants' ability to exercise free will. DISCUSSION: Biomedical HIV prevention trials present opportunities for inclusive and productive ethical and participatory practice. Key informants suggested that efforts to improve practice could result in better relationships between research stakeholders and research investigative teams and by extension, better, more ethical participatory trials. This research took place in Thailand and its findings apply primarily to Thailand. However, given the universality of many ethical considerations, the results of this study can inform the improvement of ethical

  7. Improving ethical and participatory practice for marginalized populations in biomedical HIV prevention trials: lessons from Thailand.

    Science.gov (United States)

    Allman, Dan; Ditmore, Melissa Hope; Kaplan, Karyn

    2014-01-01

    This paper presents findings from a qualitative investigation of ethical and participatory issues related to the conduct of biomedical HIV prevention trials among marginalized populations in Thailand. This research was deemed important to conduct, as several large-scale biomedical HIV prevention trials among marginalized populations had closed prematurely in other countries, and a better understanding of how to prevent similar trial closures from occurring in the future was desired. In-depth key informant interviews were held in Bangkok and Chiang Mai, Thailand. Interviews were audio recorded, transcribed, translated and thematically analyzed. The Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials (GPP) guided this work. Fourteen interviews were conducted: 10 with policymakers, academic and community-based researchers and trial staff and four with representatives of non-governmental organizations (NGOs). Suggested ways to improve ethical and participatory practice centered on standards of HIV prevention, informed consent, communication and human rights. In particular, the need to overcome language and literacy differences was identified. Key informants felt communication was the basis of ethical understanding and trust within biomedical HIV prevention trial contexts, and thus fundamental to trial participants' ability to exercise free will. Biomedical HIV prevention trials present opportunities for inclusive and productive ethical and participatory practice. Key informants suggested that efforts to improve practice could result in better relationships between research stakeholders and research investigative teams and by extension, better, more ethical participatory trials. This research took place in Thailand and its findings apply primarily to Thailand. However, given the universality of many ethical considerations, the results of this study can inform the improvement of ethical and participatory practice in other parts of the world where

  8. Population Health Trial for Smokeless Tobacco Cessation With Military Personnel

    National Research Council Canada - National Science Library

    Severson, Herbert

    2003-01-01

    ... (chewing tobacco and snuff) has not been a focus of medical services or research, Epidemiological data suggest that while smoking has continued to decline both in the general population and within the military, the use...

  9. The impact of dermatology in premier medicine journals.

    Science.gov (United States)

    Kheterpal, Meenal K; Ellis, Charles N

    2011-01-01

    In the past 15 years, research in dermatology has significantly increased. Dermatology-related contributions in premier medical journals such as The New England Journal of Medicine (NEJM) and The Journal of the American Medical Association (JAMA) are the representation of our field in the medical world. To analyze this representation, incidence of dermatology-related contributions in NEJM and JAMA during 3 separate years (during a 15-year period) was calculated.

  10. Market Segmentation, Targeting, Dan Brand Positioning Dari Winston Premier Surabaya

    OpenAIRE

    Tania, Debby

    2014-01-01

    Sejak tahun 2012 mulai terasa bahwa bisnis properti mengalami kenaikan di Indonesia. Banyak masyarakat Indonesia berinvestasi pada properti karena dianggap aman dan menguntungkan. Sehingga muncul banyak produk properti baru di Indonesia. Perkembangan properti di Indonesia menjadi peluang besar bagi Agen Properti untuk dapat menjalankan bisnisnya. Winston Premier sebagai salah satu Agen properti di Surabaya Barat yang baru berdiri memerlukan strategi pemasaran yang tepat untuk digunakan guna b...

  11. RANKING THE SPECTATORS’ DIFFICULTIES IN PURCHASING ELECTRONIC TICKETS OF FOOTBALL PREMIER LEAGUE

    Directory of Open Access Journals (Sweden)

    Ahmad Narimani

    2017-04-01

    Full Text Available This study aimed to rank the spectators’ difficulties in buying electronic tickets of football premier league matches at Azadi stadium. The population consisted of all spectators of Esteghlal-Persepolis match in the fifteenth league at Azadi stadium (N= 100000. According to Morgan table and using simple random sampling method, 500 participants were selected as sample. A researcher-made questionnaire was used for collecting the data; its face validity was confirmed by 15 experts and performing a pilot study on 30 subjects, its Cronbach’s alpha was calculated to be 0.86. Using SPSS 22, the descriptive and inferential (including Friedman test statistics was applied for analyzing the data. The findings showed that there was a significant difference between rankings of difficulties in buying electronic tickets of Football premier league matches at Azadi Stadium. The difficulties were ranked as: problem in ticket systems, early selling out of electronic tickets, lack of confidence to electronic ticket sale, lack of skill to work with the internet, low speed of internet, and lack of access to the internet

  12. Market size and attendance in English Premier League football

    OpenAIRE

    Buraimo, B; Simmons, R

    2006-01-01

    This paper models the impacts of market size and team competition for fan base on matchday attendance in the English Premier League over the period 1997-2004 using a large panel data set. We construct a comprehensive set of control variables and use tobit estimation to overcome the problems caused by sell-out crowds. We also account for unobserved influences on attendance by means of random effects attached to home teams. Our treatment of market size, with its use of Geographical Information ...

  13. 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.

  14. 75 FR 54351 - Cell and Gene Therapy Clinical Trials in Pediatric Populations; Public Workshop

    Science.gov (United States)

    2010-09-07

    ...] Cell and Gene Therapy Clinical Trials in Pediatric Populations; Public Workshop AGENCY: Food and Drug... Biologics Evaluation and Research (CBER) is announcing a public workshop entitled ``Cell and Gene Therapy... Institutional Review Boards (IRBs), gene and cellular therapy clinical researchers, and other stakeholders...

  15. Using Matrix and Tensor Factorizations for the Single-Trial Analysis of Population Spike Trains.

    Directory of Open Access Journals (Sweden)

    Arno Onken

    2016-11-01

    Full Text Available Advances in neuronal recording techniques are leading to ever larger numbers of simultaneously monitored neurons. This poses the important analytical challenge of how to capture compactly all sensory information that neural population codes carry in their spatial dimension (differences in stimulus tuning across neurons at different locations, in their temporal dimension (temporal neural response variations, or in their combination (temporally coordinated neural population firing. Here we investigate the utility of tensor factorizations of population spike trains along space and time. These factorizations decompose a dataset of single-trial population spike trains into spatial firing patterns (combinations of neurons firing together, temporal firing patterns (temporal activation of these groups of neurons and trial-dependent activation coefficients (strength of recruitment of such neural patterns on each trial. We validated various factorization methods on simulated data and on populations of ganglion cells simultaneously recorded in the salamander retina. We found that single-trial tensor space-by-time decompositions provided low-dimensional data-robust representations of spike trains that capture efficiently both their spatial and temporal information about sensory stimuli. Tensor decompositions with orthogonality constraints were the most efficient in extracting sensory information, whereas non-negative tensor decompositions worked well even on non-independent and overlapping spike patterns, and retrieved informative firing patterns expressed by the same population in response to novel stimuli. Our method showed that populations of retinal ganglion cells carried information in their spike timing on the ten-milliseconds-scale about spatial details of natural images. This information could not be recovered from the spike counts of these cells. First-spike latencies carried the majority of information provided by the whole spike train about fine

  16. Determination of the optimal sample size for a clinical trial accounting for the population size.

    Science.gov (United States)

    Stallard, Nigel; Miller, Frank; Day, Simon; Hee, Siew Wan; Madan, Jason; Zohar, Sarah; Posch, Martin

    2017-07-01

    The problem of choosing a sample size for a clinical trial is a very common one. In some settings, such as rare diseases or other small populations, the large sample sizes usually associated with the standard frequentist approach may be infeasible, suggesting that the sample size chosen should reflect the size of the population under consideration. Incorporation of the population size is possible in a decision-theoretic approach either explicitly by assuming that the population size is fixed and known, or implicitly through geometric discounting of the gain from future patients reflecting the expected population size. This paper develops such approaches. Building on previous work, an asymptotic expression is derived for the sample size for single and two-arm clinical trials in the general case of a clinical trial with a primary endpoint with a distribution of one parameter exponential family form that optimizes a utility function that quantifies the cost and gain per patient as a continuous function of this parameter. It is shown that as the size of the population, N, or expected size, N∗ in the case of geometric discounting, becomes large, the optimal trial size is O(N1/2) or O(N∗1/2). The sample size obtained from the asymptotic expression is also compared with the exact optimal sample size in examples with responses with Bernoulli and Poisson distributions, showing that the asymptotic approximations can also be reasonable in relatively small sample sizes. © 2016 The Author. Biometrical Journal published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  17. Injury profile of a professional soccer team in the premier league of iran.

    Science.gov (United States)

    Hassabi, Mohammad; Mohammad-Javad Mortazavi, Seyed; Giti, Mohammad-Reza; Hassabi, Majid; Mansournia, Mohammad-Ali; Shapouran, Sara

    2010-12-01

    Despite numerous studies which have been done regarding soccer injuries worldwide, there is lack of available data considering the epidemiology of injuries in the Iranian soccer premier league, although it is the most popular sport in the country. The main goal of this research was to determine the incidence of physical injuries in the studied population, considering other characteristics such as site, type and mechanism as well. Twenty one adult male professional soccer players (age 24±3), members of a team (Tehran-Pas) participating in Iranian premier league, were followed during a 4-month period. The injury characteristics and exposure times were recorded by the team physician during all the matches and training sessions. The total exposure time was 2610 playing hours (2352 h of training versus 258 h of competition). Eighty six percent of the injuries were acute. Incidence of acute injuries was 16.5 (95% CI: 12-22) per 1000 hours of playing (11.5 per 1000 hrs of training and 62 per 1000 hrs of competition). The most common types of injuries were strains followed by contusions, each of which constituted 30% of acute injuries. More than 80% of injuries occurred in lower limbs, especially in thigh and groin regions. Nearly 60% of acute injuries occurred in dominant side of the body, and collision was the reason of about half of the acute injuries. Severity of more than 70% of the injuries was minor. On average each injury had led the player being off the field for about 10 days. The incidence of injury in this research is in range of numbers obtained in important international tournaments but the rate of injuries during training sessions is higher than comparable studies.

  18. High-intensity running in English FA Premier League soccer matches

    DEFF Research Database (Denmark)

    Bradley, Paul S.; Sheldon, William; Wooster, Blake

    2009-01-01

    The aims of this study were to (1) determine the activity profiles of a large sample of English FA Premier League soccer players and (2) examine high-intensity running during elite-standard soccer matches for players in various playing positions. Twenty-eight English FA Premier League games were...

  19. Population Analysis of Adverse Events in Different Age Groups Using Big Clinical Trials Data.

    Science.gov (United States)

    Luo, Jake; Eldredge, Christina; Cho, Chi C; Cisler, Ron A

    2016-10-17

    Understanding adverse event patterns in clinical studies across populations is important for patient safety and protection in clinical trials as well as for developing appropriate drug therapies, procedures, and treatment plans. The objective of our study was to conduct a data-driven population-based analysis to estimate the incidence, diversity, and association patterns of adverse events by age of the clinical trials patients and participants. Two aspects of adverse event patterns were measured: (1) the adverse event incidence rate in each of the patient age groups and (2) the diversity of adverse events defined as distinct types of adverse events categorized by organ system. Statistical analysis was done on the summarized clinical trial data. The incident rate and diversity level in each of the age groups were compared with the lowest group (reference group) using t tests. Cohort data was obtained from ClinicalTrials.gov, and 186,339 clinical studies were analyzed; data were extracted from the 17,853 clinical trials that reported clinical outcomes. The total number of clinical trial participants was 6,808,619, and total number of participants affected by adverse events in these trials was 1,840,432. The trial participants were divided into eight different age groups to support cross-age group comparison. In general, children and older patients are more susceptible to adverse events in clinical trial studies. Using the lowest incidence age group as the reference group (20-29 years), the incidence rate of the 0-9 years-old group was 31.41%, approximately 1.51 times higher (P=.04) than the young adult group (20-29 years) at 20.76%. The second-highest group is the 50-59 years-old group with an incidence rate of 30.09%, significantly higher (Pgroup. The adverse event diversity also increased with increase in patient age. Clinical studies that recruited older patients (older than 40 years) were more likely to observe a diverse range of adverse events (Page group (older

  20. The Cool Little Kids randomised controlled trial: Population-level early prevention for anxiety disorders

    Directory of Open Access Journals (Sweden)

    Hiscock Harriet

    2011-01-01

    Full Text Available Abstract Background The World Health Organization predicts that by 2030 internalising problems (e.g. depression and anxiety will be second only to HIV/AIDS in international burden of disease. Internalising problems affect 1 in 7 school aged children, impacting on peer relations, school engagement, and later mental health, relationships and employment. The development of early childhood prevention for internalising problems is in its infancy. The current study follows two successful 'efficacy' trials of a parenting group intervention to reduce internalising disorders in temperamentally inhibited preschool children. Cool Little Kids is a population-level randomised trial to determine the impacts of systematically screening preschoolers for inhibition then offering a parenting group intervention, on child internalising problems and economic costs at school entry. Methods/Design This randomised trial will be conducted within the preschool service system, attended by more than 95% of Australian children in the year before starting school. In early 2011, preschool services in four local government areas in Melbourne, Australia, will distribute the screening tool. The ≈16% (n≈500 with temperamental inhibition will enter the trial. Intervention parents will be offered Cool Little Kids, a 6-session group program in the local community, focusing on ways to develop their child's bravery skills by reducing overprotective parenting interactions. Outcomes one and two years post-baseline will comprise child internalising diagnoses and symptoms, parenting interactions, and parent wellbeing. An economic evaluation (cost-consequences framework will compare incremental differences in costs of the intervention versus control children to incremental differences in outcomes, from a societal perspective. Analyses will use the intention-to-treat principle, using logistic and linear regression models (binary and continuous outcomes respectively to compare outcomes

  1. Monitoring evaluation of a spillway pilaster for Premiere Chute Dam

    Energy Technology Data Exchange (ETDEWEB)

    Crepeau, Louis; Kassem, Chakib [OSMOS Canada Inc., Montreal, (Canada)

    2010-07-01

    The Premiere-Chute hydroelectric power station, commissioned in 1968, has four hydraulic turbines for a total of 130 MW. One of the pilasters of the dam weir, built with pre-stressed concrete, showed a crack at the level of the post-tension cable. This paper presented an evaluation of the behaviour of the pilaster in question, No. 9. The main goal was to prevent any disruption to the gate opening through adequate monitoring for a long term data follow-up. Six long-base OSMOS type optical sensors were installed on each face of the spillway pilaster. The behaviour of the No. 9 pilaster was then compared with that of other pilasters with respect to the effects of temperature and water level fluctuation in the dam. After the pilasters had been monitored for six months, it was found that No. 9 pilaster showed the least deformation of all. It was therefore concluded that the behaviour of this pilaster was normal.

  2. Rapsodie first core manufacture. 1. part: processing plant; Fabrication du premier coeur de rapsodie. Premiere partie: l'atelier de fabrication

    Energy Technology Data Exchange (ETDEWEB)

    Masselot, Y; Bataller, S; Ganivet, M; Guillet, H; Robillard, A; Stosskopf, F [Commissariat a l' Energie Atomique, Cadarache (France). Centre d' Etudes Nucleaires

    1968-07-01

    This report is the first in a series of three describing the processes, results and peculiar technical problems related to the manufacture of the first core of the fast reactor Rapsodie. A detailed study of manufacturing processes(pellets, pins, fissile sub-assemblies), the associated testings (raw materials, processed pellets and pins, sub-assemblies before delivery), manufacturing facilities and improvements for a second campaign are described. (author) [French] Ce rapport est le premier d'une serie de trois qui decrivent les procedes, les resultats et les problemes techniques particuliers de la fabrication du du premier coeur de la pile a neutrons rapides Rapsodie. Il comporte une etude detaillee des procedes de fabrication (pastilles, aiguilles, assemblages combustibles) et des methodes de controle associees (matieres premieres, pastilles et aiguilles en cours de fabrication, assemblages fissiles avant livraison), ainsi qu'une decription complete des installations de l'atelier de fabrication et les modifications apportees pour une deuxieme campagne. (auteur)

  3. The Cool Little Kids randomised controlled trial: population-level early prevention for anxiety disorders.

    Science.gov (United States)

    Bayer, Jordana K; Rapee, Ronald M; Hiscock, Harriet; Ukoumunne, Obioha C; Mihalopoulos, Cathrine; Clifford, Susan; Wake, Melissa

    2011-01-05

    The World Health Organization predicts that by 2030 internalising problems (e.g. depression and anxiety) will be second only to HIV/AIDS in international burden of disease. Internalising problems affect 1 in 7 school aged children, impacting on peer relations, school engagement, and later mental health, relationships and employment. The development of early childhood prevention for internalising problems is in its infancy. The current study follows two successful 'efficacy' trials of a parenting group intervention to reduce internalising disorders in temperamentally inhibited preschool children. Cool Little Kids is a population-level randomised trial to determine the impacts of systematically screening preschoolers for inhibition then offering a parenting group intervention, on child internalising problems and economic costs at school entry. This randomised trial will be conducted within the preschool service system, attended by more than 95% of Australian children in the year before starting school. In early 2011, preschool services in four local government areas in Melbourne, Australia, will distribute the screening tool. The ≈16% (n≈500) with temperamental inhibition will enter the trial. Intervention parents will be offered Cool Little Kids, a 6-session group program in the local community, focusing on ways to develop their child's bravery skills by reducing overprotective parenting interactions. Outcomes one and two years post-baseline will comprise child internalising diagnoses and symptoms, parenting interactions, and parent wellbeing. An economic evaluation (cost-consequences framework) will compare incremental differences in costs of the intervention versus control children to incremental differences in outcomes, from a societal perspective. Analyses will use the intention-to-treat principle, using logistic and linear regression models (binary and continuous outcomes respectively) to compare outcomes between the trial arms. This trial addresses gaps

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

    Science.gov (United States)

    Jung, Sin-Ho

    2017-07-01

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

  5. How are palliative care cancer populations characterized in randomized controlled trials? A literature review.

    Science.gov (United States)

    Sigurdardottir, Katrin Ruth; Oldervoll, Line; Hjermstad, Marianne Jensen; Kaasa, Stein; Knudsen, Anne Kari; Løhre, Erik Torbjørn; Loge, Jon Håvard; Haugen, Dagny Faksvåg

    2014-05-01

    The difficulties in defining a palliative care patient accentuate the need to provide stringent descriptions of the patient population in palliative care research. To conduct a systematic literature review with the aim of identifying which key variables have been used to describe adult palliative care cancer populations in randomized controlled trials (RCTs). The data sources used were MEDLINE (1950 to January 25, 2010) and Embase (1980 to January 25, 2010), limited to RCTs in adult cancer patients with incurable disease. Forty-three variables were systematically extracted from the eligible articles. The review includes 336 articles reporting RCTs in palliative care cancer patients. Age (98%), gender (90%), cancer diagnosis (89%), performance status (45%), and survival (45%) were the most frequently reported variables. A large number of other variables were much less frequently reported. A substantial variation exists in how palliative care cancer populations are described in RCTs. Few variables are consistently registered and reported. There is a clear need to standardize the reporting. The results from this work will serve as the basis for an international Delphi process with the aim of reaching consensus on a minimum set of descriptors to characterize a palliative care cancer population. Copyright © 2014 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

  6. NHS health checks through general practice: randomised trial of population cardiovascular risk reduction

    Directory of Open Access Journals (Sweden)

    Cochrane Thomas

    2012-11-01

    Full Text Available Abstract Background The global burden of the major vascular diseases is projected to rise and to remain the dominant non-communicable disease cluster well into the twenty first century. The Department of Health in England has developed the NHS Health Check service as a policy initiative to reduce population vascular disease risk. The aims of this study were to monitor population changes in cardiovascular disease (CVD risk factors over the first year of the new service and to assess the value of tailored lifestyle support, including motivational interview with ongoing support and referral to other services. Methods Randomised trial comparing NHS Health Check service only with NHS Health Check service plus additional lifestyle support in Stoke on Trent, England. Thirty eight general practices and 601 (365 usual care, 236 additional lifestyle support patients were recruited and randomised independently between September 2009 and February 2010. Changes in population CVD risk between baseline and one year follow-up were compared, using intention-to-treat analysis. The primary outcome was the Framingham 10 year CVD risk score. Secondary outcomes included individual modifiable risk measures and prevalence of individual risk categories. Additional lifestyle support included referral to a lifestyle coach and free sessions as needed for: weight management, physical activity, cook and eat and positive thinking. Results Average population CVD risk decreased from 32.9% to 29.4% (p Conclusions The NHS Health Check service in Stoke on Trent resulted in significant reduction in estimated population CVD risk. There was no evidence of further benefit of the additional lifestyle support services in terms of absolute CVD risk reduction.

  7. Randomized trial of a population-based, home-delivered intervention for preschool language delay.

    Science.gov (United States)

    Wake, Melissa; Tobin, Sherryn; Levickis, Penny; Gold, Lisa; Ukoumunne, Obioha C; Zens, Naomi; Goldfeld, Sharon; Le, Ha; Law, James; Reilly, Sheena

    2013-10-01

    Population approaches to lessen the adverse impacts of preschool language delay remain elusive. We aimed to determine whether systematic ascertainment of language delay at age 4 years, followed by a 10-month, 1-on-1 intervention, improves language and related outcomes at age 5 years. A randomized trial nested within a cross-sectional ascertainment of language delay. Children with expressive and/or receptive language scores more than 1.25 SD below the mean at age 4 years entered the trial. Children randomly allocated to the intervention received 18 1-hour home-based therapy sessions. The primary outcomes were receptive and expressive language (Clinical Evaluation of Language Fundamentals - Preschool, 2(nd) Edition) and secondary outcomes were child phonological skills, letter awareness, pragmatic skills, behavior, and quality of life. A total of 1464 children were assessed for language delay at age 4 years. Of 266 eligible children, 200 (13.6%) entered the trial, with 91 intervention (92% of 99) and 88 control (87% of 101) children retained at age 5 years. At age 5 years, there was weak evidence of benefit to expressive (adjusted mean difference, intervention - control, 2.0; 95% confidence interval [CI] -0.5 to 4.4; P = .12) but not receptive (0.6; 95% CI -2.5 to 3.8; P = .69) language. The intervention improved phonological awareness skills (5.0; 95% CI 2.2 to 7.8; P language intervention was successfully delivered by non-specialist staff, found to be acceptable and feasible, and has the potential to improve long-term consequences of early language delay within a public health framework.

  8. Population preference of net texture prior to bed net trial in Kala-Azar-endemic areas.

    Directory of Open Access Journals (Sweden)

    Murari L Das

    Full Text Available Prior to a community-based efficacy trial of long-lasting insecticidal nets (LLINs in the prevention of visceral leishmaniasis (VL; also called kala-azar, a pilot study on preference of tools was held in endemic areas of India and Nepal in September 2005.LLINs made of polyester and polyethylene were distributed to 60 participants, who used the nets sequentially for 7 d. Acceptability and preference were evaluated via indirect indicators through questionnaires at three defined time points before and after use of the LLINs and through focus group discussions (FGDs. In the latter, preferences for color and size were also assessed. Untreated bed nets were owned by 87% of the households prior to the study. All users liked textures of both LLIN types after 7 d of use, but had a slight preference for those made of polyester if they were to recommend a LLIN to relatives or friends (p<0.05, mainly because of their relatively greater softness in comparison to polyethylene LLINs. Users reported that both net types reduced mosquito bites and number of insects, including sand fly (bhusana; genus Phlebotomus, inside the house. Side effects were minor and disappeared quickly.The large-scale intervention trial considered the preferences of the study population to decide on the best tool of intervention--light-blue, rectangular, polyester LLINs of different sizes.

  9. Liver safety assessment in special populations (hepatitis B, C, and oncology trials).

    Science.gov (United States)

    Kullak-Ublick, Gerd A; Merz, Michael; Griffel, Louis; Kaplowitz, Neil; Watkins, Paul B

    2014-11-01

    The FDA guidance for industry in the premarketing clinical evaluation of drug-induced liver injury (DILI) is the most specific regulatory guidance currently available and has been useful in setting standards for the great majority of clinical indications involving subjects with a low risk of liver disorders. However, liver safety assessment faces challenges in populations with underlying liver disease, such as viral hepatitis or metastatic cancer. This is an important issue because there are currently many promising anti-viral and oncologic therapies in clinical development, with a trend toward oral therapies with reduced side effects. Without clearer guidelines, questions regarding liver safety may become a major factor in regulatory approval and ultimately physician uptake of the new treatments. The lack of consensus in defining stopping rules based on serum alanine aminotransferase (ALT) levels underscores the need for precompetitive data sharing to improve our understanding of DILI in these populations and to allow evidence-based rather than empirical definition of stopping rules. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

  10. NASA Names Premier X-Ray Observatory and Schedules Launch

    Science.gov (United States)

    1998-12-01

    NASA's Advanced X-ray Astrophysics Facility has been renamed the Chandra X-ray Observatory in honor of the late Indian-American Nobel laureate, Subrahmanyan Chandrasekhar. The telescope is scheduled to be launched no earlier than April 8, 1999 aboard the Space Shuttle Columbia mission STS-93, commanded by astronaut Eileen Collins. Chandrasekhar, known to the world as Chandra, which means "moon" or "luminous" in Sanskrit, was a popular entry in a recent NASA contest to name the spacecraft. The contest drew more than six thousand entries from fifty states and sixty-one countries. The co-winners were a tenth grade student in Laclede, Idaho, and a high school teacher in Camarillo, CA. The Chandra X-ray Observatory Center (CXC), operated by the Smithsonian Astrophysical Observatory, will control science and flight operations of the Chandra X-ray Observatory for NASA from Cambridge, Mass. "Chandra is a highly appropriate name," said Harvey Tananbaum, Director of the CXC. "Throughout his life Chandra worked tirelessly and with great precision to further our understanding of the universe. These same qualities characterize the many individuals who have devoted much of their careers to building this premier X-ray observatory." "Chandra probably thought longer and deeper about our universe than anyone since Einstein," said Martin Rees, Great Britain's Astronomer Royal. "Chandrasekhar made fundamental contributions to the theory of black holes and other phenomena that the Chandra X-ray Observatory will study. His life and work exemplify the excellence that we can hope to achieve with this great observatory," said NASA Administrator Dan Goldin. Widely regarded as one of the foremost astrophysicists of the 20th century, Chandrasekhar won the Nobel Prize in 1983 for his theoretical studies of physical processes important to the structure and evolution of stars. He and his wife immigrated from India to the U.S. in 1935. Chandrasekhar served on the faculty of the University of

  11. 40Ar-39Ar laser probe dating of individual clinopyroxene inclusions in Premier eclogitic diamonds

    International Nuclear Information System (INIS)

    Burgess, R.; Turner, G.; Laurenzi, M.; Harris, J.W.

    1989-01-01

    The ages of seven individual clinopyroxene inclusions in Premier diamonds of eclogitic association have been determined using the 40 Ar- 39 Ar dating technique. Syngenetic inclusions weighing between 10 and 130 μg were exposed on cleaved surfaces of the diamonds and analysed using a laser probe. The inclusion ages were found to be in the range 1111±35 to 1254±38 Ma with an average of 1185±94 Ma. The ages obtained are in good agreement with previous determinations made on aggregates of eclogitic inclusions from Premier diamonds and demonstrate the applicability of the laser probe to dating individual diamond inclusions. (orig.)

  12. How to Revise, and Revise Really Well, for Premier Academic Journals

    DEFF Research Database (Denmark)

    LaPlaca, Peter J.; Lindgreen, Adam; Vanhamme, Joelle

    2018-01-01

    Most of the premier academic journals in all fields routinely have rejection rates of 80%, 95%, or higher. All journals prefer articles that make significant contributions to the field. Revising a manuscript and responding properly to the comments of reviewers and editors often is challenging....... This article discusses how to revise effectively a manuscript according to the (minor or major) comments of reviewers and editors for premier academic journals. We provide a series of tips for helping the authors in their endeavor, making the process less arduous and improving the possibility of a positive...

  13. Community-wide intervention and population-level physical activity: a 5-year cluster randomized trial

    Science.gov (United States)

    Kamada, Masamitsu; Kitayuguchi, Jun; Abe, Takafumi; Taguri, Masataka; Inoue, Shigeru; Ishikawa, Yoshiki; Bauman, Adrian; Lee, I-Min; Miyachi, Motohiko; Kawachi, Ichiro

    2018-01-01

    Abstract Background Evidence from a limited number of short-term trials indicates the difficulty in achieving population-level improvements in physical activity (PA) through community-wide interventions (CWIs). We sought to evaluate the effectiveness of a 5-year CWI for promoting PA in middle-aged and older adults using a cluster randomized design. Methods We randomized 12 communities in Unnan, Japan, to either intervention (9) or control (3). Additionally, intervention communities were randomly allocated to three subgroups by different PA types promoted. Randomly sampled residents aged 40–79 years responded to the baseline survey (n = 4414; 74%) and were followed at 1, 3 and 5 years (78–83% response rate). The intervention was a 5-year CWI using social marketing to promote PA. The primary outcome was a change in recommended levels of PA. Results Compared with control communities, adults achieving recommended levels of PA increased in intervention communities [adjusted change difference = 4.6 percentage points (95% confidence interval: 0.4, 8.8)]. The intervention was effective for promoting all types of recommended PAs, i.e. aerobic (walking, 6.4%), flexibility (6.1%) and muscle-strengthening activities (5.7%). However, a bundled approach, which attempted to promote all forms of PAs above simultaneously, was not effective (1.3–3.4%, P ≥ 0.138). Linear dose–response relationships between the CWI awareness and changes in PA were observed (P ≤ 0.02). Pain intensity decreased in shoulder (intervention and control) and lower back (intervention only) but there was little change difference in all musculoskeletal pain outcomes between the groups. Conclusions The 5-year CWI using the focused social marketing strategy increased the population-level of PA. PMID:29228255

  14. Adaptive genetic variability and differentiation of Croatian and Austrian Quercus robur L. populations at a drought prone field trial

    Directory of Open Access Journals (Sweden)

    Saša Bogdan

    2017-07-01

    Full Text Available Provenance trials, where populations of different geographical origin are tested in a common environment (common garden test, are a tool suited to allow the study of intraspecific adaptive genetic variation. Research of pedunculate oak (Quercus robur L. adaptive genetic variability through analyses of populations in common garden tests has a long tradition. However, pedunculated oak populations originating south-eastern from the Alps have been scarcely studied in this way. This study addresses the adaptive genetic variability and differentiation of pedunculate oak populations originating from Austria and Croatia in a provenance/progeny field trial. Studied plants were six years old and were growing at the trial for three years. After two years of unusually low precipitations height and survival were analysed. The total mean height of all plants in the trial was 137.8 cm and ranged from 123.0 cm to 151.8 cm. The overall mean survival rate was rather high (0.85. Mean population survival ranged from 0.64 to 0.94. Individual narrow-sense heritabilities (hi2, family mean heritabilities (hf2, the coefficients of additive genetic variation (CVA and quantitative genetic differentiation coefficients (QST were calculated. A multivariate regression tree (MRT analysis was used to determine the pattern of genetic differentiation of the populations. Individual heritabilities for height ranged between 0.00 and 0.39. Family mean heritabilities for height were rather low in most populations as well (<0.5. Family mean heritabilities for survival were higher than for height (ranging between 0.00 and 0.77. Calculated QST coefficients (0.25 for height and 0.14 for survival indicated between-population genetic differentiation. The populations were separated into two clusters by MRT analysis regarding a climatic variable, namely Hargreaves’ reference evapotranspiration. Populations originating from comparatively more humid habitats were grouped in the first

  15. IMPROVEMENTS FOR THE OPERATION OF CHINESE FOOTBALL LEAGUE BY ANALYSING THE SUCCESS ASSETS OF ENGLISH PREMIER LEAGUE

    OpenAIRE

    Cao, Hanxiong

    2012-01-01

    The purpose of this thesis is going to analyze the success assets of English Premier League (which is now the most successful football league in the world) and the defects of Chinese Super League by analyzing the financial statements of the Premier League, and try to make some possible improvements for Chinese Super League according to the results of the analysis.

  16. Effectiveness of in-season manager changes in English Premier League Football

    NARCIS (Netherlands)

    Besters, Lucas; van Ours, Jan; van Tuijl, Martin

    We analyze the performance effects of in-season manager changes in English Premier League football during the seasons 2000/2001–2014/2015. We find that some managerial changes are successful, while others are counterproductive. On average, performance does not improve following a managerial

  17. The long-term effect of premier pay for performance on patient outcomes.

    Science.gov (United States)

    Jha, Ashish K; Joynt, Karen E; Orav, E John; Epstein, Arnold M

    2012-04-26

    Pay for performance has become a central strategy in the drive to improve health care. We assessed the long-term effect of the Medicare Premier Hospital Quality Incentive Demonstration (HQID) on patient outcomes. We used Medicare data to compare outcomes between the 252 hospitals participating in the Premier HQID and 3363 control hospitals participating in public reporting alone. We examined 30-day mortality among more than 6 million patients who had acute myocardial infarction, congestive heart failure, or pneumonia or who underwent coronary-artery bypass grafting (CABG) between 2003 and 2009. At baseline, the composite 30-day mortality was similar for Premier and non-Premier hospitals (12.33% and 12.40%, respectively; difference, -0.07 percentage points; 95% confidence interval [CI], -0.40 to 0.26). The rates of decline in mortality per quarter at the two types of hospitals were also similar (0.04% and 0.04%, respectively; difference, -0.01 percentage points; 95% CI, -0.02 to 0.01), and mortality remained similar after 6 years under the pay-for-performance system (11.82% for Premier hospitals and 11.74% for non-Premier hospitals; difference, 0.08 percentage points; 95% CI, -0.30 to 0.46). We found that the effects of pay for performance on mortality did not differ significantly among conditions for which outcomes were explicitly linked to incentives (acute myocardial infarction and CABG) and among conditions not linked to incentives (congestive heart failure and pneumonia) (P=0.36 for interaction). Among hospitals that were poor performers at baseline, mortality was similar in the two groups of hospitals at the start of the study (15.12% and 14.73%; difference, 0.39 percentage points; 95% CI, -0.36 to 1.15), with similar rates of improvement per quarter (0.10% and 0.07%; difference, -0.03 percentage points; 95% CI, -0.08 to 0.02) and similar mortality rates at the end of the study (13.37% and 13.21%; difference, 0.15 percentage points; 95% CI, -0.70 to 1.01). We

  18. Most children with cancer are not enrolled on a clinical trial in Canada: a population-based study.

    Science.gov (United States)

    Pole, Jason D; Barber, Randy; Bergeron, Rose-Émilie; Carret, Anne Sophie; Dix, David; Kulkarni, Ketan; Martineau, Emilie; Randall, Alicia; Stammers, David; Strahlendorf, Caron; Strother, Douglas R; Truong, Tony H; Sung, Lillian

    2017-06-05

    Primary objective was to describe the proportion of children newly diagnosed with cancer enrolled on a therapeutic clinical trial. Secondary objectives were to describe reasons for non-enrollment and factors associated with enrollment on trials. In this retrospective cohort study, we included children newly diagnosed with cancer between 0 and 14 years of age and diagnosed from 2001 to 2012. We used data from the Cancer in Young People in Canada (CYP-C) national pediatric cancer population-based database. CYP-C captures all cases of pediatric cancer (0-14 years) diagnosed and treated at one of the 17 tertiary pediatric oncology centers in Canada. Non-enrollment was evaluated using univariate and multiple logistic regression analysis. There were 9204 children with cancer included, of whom 2533 (27.5%) were enrolled on a clinical trial. The most common reasons cited for non-enrollment were lack of an available trial (52.2%) and physician choice (11.2%). In multiple regression, Asian and Arab/west Asian race were associated with lower enrollment (P = 0.006 and P = 0.032 respectively). All cancer diagnoses were more likely to be enrolled compared to astrocytoma and children with acute lymphoblastic leukemia had an almost 18-fold increased odds of enrollment compared to astrocytoma (P Canada, 27.5% of children with cancer are enrolled onto therapeutic clinical trials and lack of an available trial is the most common reason contributing to non-enrollment. Future research should better understand reasons for lack of trial availability and physician preferences to not offer trials.

  19. Effects of rearing environment and population origin on responses to repeated behavioural trials in cane toads (Rhinella marina).

    Science.gov (United States)

    Gruber, Jodie; Whiting, Martin J; Brown, Gregory; Shine, Richard

    2018-05-02

    Behavioural response to repeated trials in captivity can be driven by many factors including rearing environment, population of origin, habituation to captivity/trial conditions and an individual's behavioural type (e.g., bold versus shy). We tested the effect of rearing environment (captive raised common-garden versus wild-caught) and population origin (range-edge versus range-front) on the responses of invasive cane toads (Rhinella marina) to repeated exploration and risk-taking assays in captivity. We found that behavioural responses to identical assays performed on two occasions were complex and showed few consistent patterns based on rearing environment or population of origin. However, behavioural traits were repeatable across Trial Blocks when all sample populations were grouped together, indicating general consistency in individual toad behaviour across repeated behavioural assays. Our findings exemplify the complexity and unpredictability of behavioural responses and their effects on the repeatability and interpretation of behavioural traits across repeated behavioural assays in captivity. To meaningfully interpret the results from repeated behavioural assays, we need to consider how multiple factors may affect behavioural responses to these tests and importantly, how these responses may affect the repeatability of behavioural traits across time. Copyright © 2018. Published by Elsevier B.V.

  20. Population-level effects of automated smoking cessation help programs: a randomized controlled trial.

    Science.gov (United States)

    Borland, Ron; Balmford, James; Benda, Peter

    2013-03-01

    To test the population impact of offering automated smoking cessation interventions via the internet and/or by mobile phone. Pragmatic randomized controlled trial with five conditions: offer of (i) minimal intervention control; (ii) QuitCoach personalized tailored internet-delivered advice program; (iii) onQ, an interactive automated text-messaging program; (iv) an integration of both QuitCoach and onQ; and (v) a choice of either alone or the combined program. Australia, via a mix of internet and telephone contacts. A total of 3530 smokers or recent quitters recruited from those interested in quitting, and seeking self-help resources (n = 1335) or cold-contacted from internet panels (n = 2195). The primary outcome was self-report of 6 months sustained abstinence at 7 months post-recruitment. Only 42.5% of those offered one of the interventions took it up to a minimal level. The intervention groups combined had a non-significantly higher 6-month sustained abstinence rate than the control [odds ratio (OR) = 1.48; 95% confidence interval (CI): 0.98-2.24] (missing cases treated as smokers), with no differences between the interventions. Among those who used an intervention, there was a significant overall increase in abstinence (OR = 1.95; CI: 1.04-3.67), but not clearly so when analysing only cases with reported outcomes. Success rates were greater among those recruited after seeking information compared to those cold-contacted. Smokers interested in quitting who were assigned randomly to an offer of either the QuitCoach internet-based support program and/or the interactive automated text-messaging program had non-significantly greater odds of quitting for at least 6 months than those randomized to an offer of a simple information website. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.

  1. Lessons learned from IDeAl - 33 recommendations from the IDeAl-net about design and analysis of small population clinical trials.

    Science.gov (United States)

    Hilgers, Ralf-Dieter; Bogdan, Malgorzata; Burman, Carl-Fredrik; Dette, Holger; Karlsson, Mats; König, Franz; Male, Christoph; Mentré, France; Molenberghs, Geert; Senn, Stephen

    2018-05-11

    IDeAl (Integrated designs and analysis of small population clinical trials) is an EU funded project developing new statistical design and analysis methodologies for clinical trials in small population groups. Here we provide an overview of IDeAl findings and give recommendations to applied researchers. The description of the findings is broken down by the nine scientific IDeAl work packages and summarizes results from the project's more than 60 publications to date in peer reviewed journals. In addition, we applied text mining to evaluate the publications and the IDeAl work packages' output in relation to the design and analysis terms derived from in the IRDiRC task force report on small population clinical trials. The results are summarized, describing the developments from an applied viewpoint. The main result presented here are 33 practical recommendations drawn from the work, giving researchers a comprehensive guidance to the improved methodology. In particular, the findings will help design and analyse efficient clinical trials in rare diseases with limited number of patients available. We developed a network representation relating the hot topics developed by the IRDiRC task force on small population clinical trials to IDeAl's work as well as relating important methodologies by IDeAl's definition necessary to consider in design and analysis of small-population clinical trials. These network representation establish a new perspective on design and analysis of small-population clinical trials. IDeAl has provided a huge number of options to refine the statistical methodology for small-population clinical trials from various perspectives. A total of 33 recommendations developed and related to the work packages help the researcher to design small population clinical trial. The route to improvements is displayed in IDeAl-network representing important statistical methodological skills necessary to design and analysis of small-population clinical trials. The methods

  2. Value of information methods to design a clinical trial in a small population to optimise a health economic utility function.

    Science.gov (United States)

    Pearce, Michael; Hee, Siew Wan; Madan, Jason; Posch, Martin; Day, Simon; Miller, Frank; Zohar, Sarah; Stallard, Nigel

    2018-02-08

    Most confirmatory randomised controlled clinical trials (RCTs) are designed with specified power, usually 80% or 90%, for a hypothesis test conducted at a given significance level, usually 2.5% for a one-sided test. Approval of the experimental treatment by regulatory agencies is then based on the result of such a significance test with other information to balance the risk of adverse events against the benefit of the treatment to future patients. In the setting of a rare disease, recruiting sufficient patients to achieve conventional error rates for clinically reasonable effect sizes may be infeasible, suggesting that the decision-making process should reflect the size of the target population. We considered the use of a decision-theoretic value of information (VOI) method to obtain the optimal sample size and significance level for confirmatory RCTs in a range of settings. We assume the decision maker represents society. For simplicity we assume the primary endpoint to be normally distributed with unknown mean following some normal prior distribution representing information on the anticipated effectiveness of the therapy available before the trial. The method is illustrated by an application in an RCT in haemophilia A. We explicitly specify the utility in terms of improvement in primary outcome and compare this with the costs of treating patients, both financial and in terms of potential harm, during the trial and in the future. The optimal sample size for the clinical trial decreases as the size of the population decreases. For non-zero cost of treating future patients, either monetary or in terms of potential harmful effects, stronger evidence is required for approval as the population size increases, though this is not the case if the costs of treating future patients are ignored. Decision-theoretic VOI methods offer a flexible approach with both type I error rate and power (or equivalently trial sample size) depending on the size of the future population for

  3. Value of information methods to design a clinical trial in a small population to optimise a health economic utility function

    Directory of Open Access Journals (Sweden)

    Michael Pearce

    2018-02-01

    Full Text Available Abstract Background Most confirmatory randomised controlled clinical trials (RCTs are designed with specified power, usually 80% or 90%, for a hypothesis test conducted at a given significance level, usually 2.5% for a one-sided test. Approval of the experimental treatment by regulatory agencies is then based on the result of such a significance test with other information to balance the risk of adverse events against the benefit of the treatment to future patients. In the setting of a rare disease, recruiting sufficient patients to achieve conventional error rates for clinically reasonable effect sizes may be infeasible, suggesting that the decision-making process should reflect the size of the target population. Methods We considered the use of a decision-theoretic value of information (VOI method to obtain the optimal sample size and significance level for confirmatory RCTs in a range of settings. We assume the decision maker represents society. For simplicity we assume the primary endpoint to be normally distributed with unknown mean following some normal prior distribution representing information on the anticipated effectiveness of the therapy available before the trial. The method is illustrated by an application in an RCT in haemophilia A. We explicitly specify the utility in terms of improvement in primary outcome and compare this with the costs of treating patients, both financial and in terms of potential harm, during the trial and in the future. Results The optimal sample size for the clinical trial decreases as the size of the population decreases. For non-zero cost of treating future patients, either monetary or in terms of potential harmful effects, stronger evidence is required for approval as the population size increases, though this is not the case if the costs of treating future patients are ignored. Conclusions Decision-theoretic VOI methods offer a flexible approach with both type I error rate and power (or equivalently

  4. Effectiveness of structured, hospital-based, nurse-led atrial fibrillation clinics: a comparison between a real-world population and a clinical trial population.

    Science.gov (United States)

    Qvist, Ina; Hendriks, Jeroen M L; Møller, Dorthe S; Albertsen, Andi E; Mogensen, Helle M; Oddershede, Gitte D; Odgaard, Annette; Mortensen, Leif Spange; Johnsen, Søren Paaske; Frost, Lars

    2016-01-01

    A previous randomised trial showed that structured, nurse-led atrial fibrillation (AF) care is superior to conventional AF care, although further research is needed to determine the outcomes of such care in a real-world setting. We compared the outcomes of patients in real-world, nurse-led, structured hospital AF clinics with the outcomes of a randomised trial of the efficacy of a nurse-led AF clinic, with respect to a composite outcome of cardiovascular-related hospitalisation and death. All patients were referred to the AF nurse specialist by cardiologists. The AF nurse specialist provided patient education, risk-factor control and stimulated empowerment and compliance. During follow-up, treatment was adjusted according to clinical guidelines. Patient education was repeated, and compliance with medical treatment was controlled. The study size was powered as a non-inferiority study. Outcome measures were adjudicated by the same principles in both cohorts. A total of 596 patients from the real world and 356 patients from a clinical trial were included in this study. No significant difference between groups with respect to age, type of AF or CHA2DS2VASc score was found. The composite primary end point occurred with an incidence rate of 8.0 (95% CI 6.1 to 10.4) per 100 person-years in the real-world population and 8.3 (95% CI 6.3 to 10.9) per 100 person-years in the clinical trial, with a crude HR of 0.83 (95% CI 0.56 to 1.23). Structured, nurse-led, hospital-based AF care appears to be effective, and patient outcomes in an actual, hospital-based, structured AF care are as least as good as those in trial settings.

  5. Addendum to "Population-Based Prevention of Child Maltreatment: The U.S. Triple P System Population Trial".

    Science.gov (United States)

    Prinz, Ronald J; Sanders, Matthew R; Shapiro, Cheri J; Whitaker, Daniel J; Lutzker, John R

    2016-04-01

    A previous article published several years ago (Prinz et al. Prevention Science, 10, 1-12, 2009) described the main results of a place-randomized-design study focused on the prevention of child-maltreatment-related outcomes at a population level through the implementation of a multilevel system of parenting and family support (the Triple P-Positive Parenting Program). The current report, prepared at the encouragement of the journal, provides additional details about procedures, measures, and design-related decisions, presents an additional analysis of the main outcome variables, and poses questions about the study and its implications. We also offer guidance about how the field can move forward to build on this line of research. From the outset, the three designated primary child maltreatment outcomes were county-wide rates for substantiated child maltreatment cases, out-of-home placements, and hospital-treated child maltreatment injuries, derived from independent data sources available through administrative archival records. Baseline equivalence between the two intervention conditions was reaffirmed. The additional analysis, which made use of a 5-year baseline (replacing a 1-year baseline) and ANCOVA, yielded large effect sizes for all three outcomes that converged with those from the original analyses. Overall, the study underscored the potential for community-wide parenting and family support to produce population-level preventive impact on child maltreatment. Issues addressed included (1) the need for replication of population-oriented maltreatment prevention strategies like the one tested in this randomized experiment, (2) the need to demonstrate that a parenting-based population approach to maltreatment prevention can also impact children's adjustment apart from child abuse, and (3) the role of implementation science for achieving greater population reach and maintenance over time.

  6. Glycemic index and glycemic load are associated with some cardiovascular risk factors among the PREMIER study participants

    Directory of Open Access Journals (Sweden)

    Pao-Hwa Lin

    2012-06-01

    Full Text Available Background: The clinical significance of glycemic index (GI and glycemic load (GL is inconclusive. Objective : This study was conducted to examine the association of GI and GL with clinical cardiovascular disease (CVD risk factors including body weight, blood pressure (BP, serum lipids, fasting glucose, insulin and homocysteine over time among the PREMIER participants. Design: PREMIER was an 18-month randomized lifestyle intervention trial, conducted from 2000 to 2002, designed to help participants reduce BP by following the Dietary Approaches to Stop Hypertension (DASH dietary pattern, losing weight, reducing sodium and increasing physical activity. GI and GL were estimated from 24 h diet recall data at baseline, 6 and 18 months after intervention. PROC MIXED model was used to examine the association of changes in GI or GL with changes in CVD risk factors. Results: A total of 756 randomized participants, 62% females and 34% African Americans and who averaged 50.0±0.3 years old and 95.3±0.7 kg, were included in this report. Neither GI nor GL changes was associated with changes in any risk factors at 6 months. At 18 months, however, the GI change was significantly and positively associated with total cholesterol (TC change only (p<0.05, β = 23.80±12.11 mg/dL or 0.62±0.31 mmol/L with a significant age interaction. The GL change was significantly associated with TC (p=0.02, β = 0.28±0.15 mg/dL or 0.01±0.00 mmol/L positively and with low density lipoprotein cholesterol (LDL-C changes negatively (p=0.03, β = − 0.01±0.00 mg/dL or −0.00±0.00 mmol/L, and significant age interactions were observed for both. Conclusion: GI and GL was associated with TC and LDL-C after controlling for energy, fat and fiber intake and other potential confounders and the associations were modified by age. Further investigation into this relationship is important because of its potential clinical impact.

  7. Mortality results from the Göteborg randomised population-based prostate-cancer screening trial.

    Science.gov (United States)

    Hugosson, Jonas; Carlsson, Sigrid; Aus, Gunnar; Bergdahl, Svante; Khatami, Ali; Lodding, Pär; Pihl, Carl-Gustaf; Stranne, Johan; Holmberg, Erik; Lilja, Hans

    2010-08-01

    Prostate cancer is one of the leading causes of death from malignant disease among men in the developed world. One strategy to decrease the risk of death from this disease is screening with prostate-specific antigen (PSA); however, the extent of benefit and harm with such screening is under continuous debate. In December, 1994, 20,000 men born between 1930 and 1944, randomly sampled from the population register, were randomised by computer in a 1:1 ratio to either a screening group invited for PSA testing every 2 years (n=10,000) or to a control group not invited (n=10,000). Men in the screening group were invited up to the upper age limit (median 69, range 67-71 years) and only men with raised PSA concentrations were offered additional tests such as digital rectal examination and prostate biopsies. The primary endpoint was prostate-cancer specific mortality, analysed according to the intention-to-screen principle. The study is ongoing, with men who have not reached the upper age limit invited for PSA testing. This is the first planned report on cumulative prostate-cancer incidence and mortality calculated up to Dec 31, 2008. This study is registered as an International Standard Randomised Controlled Trial ISRCTN54449243. In each group, 48 men were excluded from the analysis because of death or emigration before the randomisation date, or prevalent prostate cancer. In men randomised to screening, 7578 (76%) of 9952 attended at least once. During a median follow-up of 14 years, 1138 men in the screening group and 718 in the control group were diagnosed with prostate cancer, resulting in a cumulative prostate-cancer incidence of 12.7% in the screening group and 8.2% in the control group (hazard ratio 1.64; 95% CI 1.50-1.80; pattendees compared with the control group was 0.44 (95% CI 0.28-0.68; p=0.0002). Overall, 293 (95% CI 177-799) men needed to be invited for screening and 12 to be diagnosed to prevent one prostate cancer death. This study shows that prostate

  8. Analisis Pengaruh Kualitas Pelayanan Terhadap Kepuasan Pelanggan pada Hotel Santika Premiere Dyandra Medan

    OpenAIRE

    Purba, Mey Royani M.

    2013-01-01

    Quality of service is an expected level of excellence and control over the level of excellence to comply the customer wants. Satisfaction is the difference between the perceived performance with expectations. This study aimed to to identify and analyze the influence of the quality of services consisting of physical tangible, reliability, responsiveness, assurance, and empathy to customer satisfaction on Santika Premiere Dyandra Hotel. To measure service quality from the point of servic...

  9. Analisis Kualitas Pelayanan terhadap Kepuasan Konsumen Jasa Hotel Santika Premiere Semarang

    OpenAIRE

    Dewangga, Nandy; Hidayat, Wahyu; Widiartanto, Widiartanto

    2014-01-01

    The competition of global business today focusing on consumers is a strategic choice in business world in order to survive. For example, the tight competition of business in the company of hotel services is by improving the service quality to consumers. The problems in this research were the decreasing number of hotel service users and the increasing number of consumer complaint as the service users of Santika Premiere Hotel in Semarang from year to year. The aims of this research were to ide...

  10. Effectiveness of in-season manager changes in English Premier League Football

    OpenAIRE

    Besters, Lucas; van Ours, Jan; van Tuijl, Martin

    2016-01-01

    We analyze the performance effects of in-season manager changes in English Premier League football during the seasons 2000/2001–2014/2015. We find that some managerial changes are successful, while others are counterproductive. On average, performance does not improve following a managerial replacement. The successfulness of managerial turnover depends on specific highly unpredictable circumstances, as we illustrate through case-studies.

  11. Un premier service mobile en Égypte qui relie les petits exploitants ...

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

    Un premier service mobile en Égypte qui relie les petits exploitants aux acheteurs. Un homme qui parle sur un téléphone mobile. Les petits exploitants agricoles dominent l'agriculture égyptienne, mais leur manque de connaissances en matière de commercialisation et de compétences techniques, ainsi qu'une mauvaise ...

  12. 40Ar/39Ar laser-probe dating of diamond inclusions from the Premier kimberlite

    International Nuclear Information System (INIS)

    Phillips, D.; Onstott, T.C.; Harris, J.W.; Strathclyde Univ., Glasgow

    1989-01-01

    Inclusions encapsulated by diamonds at the time of their formation provide a means for determining diamond crystallization ages and the chemistry of the surrounding upper mantle at that time. Sm-Nd studies of peridotitic inclusions, from Cretaceous-age kimberlites in southern Africa, suggest that the diamonds formed 3.3 Gyr ago. By contrast, eclogite-suite inclusions generally yield younger ages, sometimes approaching the time of kimberlite eruption. Here we report the results of 40 Ar/ 39 Ar laser-probe analyses of individual eclogitic clinopyroxene inclusions from Premier diamonds, which yield a mean age of 1,198±14 Myr. This age agrees well with Sm-Nd and 40 Ar/ 39 Ar analyses on similar Premier inclusions, and is indistinguishable from the inferred time of emplacement of the host kimberlite (1,150-1,230 Myr), which implies that diamond formation was essentially synchronous with kimberlite generation. The extrapolated non-radiogenic 40 Ar/ 36 Ar ratio of 334±102 is similar to the present-day atmospheric composition. This value is inconsistent with Sr and Nd isotopic signatures from Premier eclogite inclusions, which suggest a depleted mantle source ( 40 Ar/ 36 Ar>20,000). Pre-entrapment equilibration of the inclusions with an 36 Ar-rich fluid is the most probable explanation for the low non-radiogenic ( 40 Ar/ 36 Ar) composition. (author)

  13. Logistique de transport pour le projet LHC enseignements des premiers secteurs

    CERN Document Server

    Prodon, S

    2003-01-01

    Ce papier dresse un premier bilan de la logistique de transport mise en place pour l'installation du LHC. Les moyens de planification mis en oeuvre seront tout d'abord évoqués avec notamment les réunions avec les groupes utilisateurs, l'élaboration de procédures de transport, la génération de listings d'articles à transporter ou encore l'établissement d'un planning des ressources. Cependant, les premiers travaux d'installation du LHC ont fait apparaître des divergences importantes entre le planning logistique établi et la réalité du terrain. Ces écarts seront analysés, qu'il s'agisse de différences sur le volume de matériel à acheminer, d'opérations non planifiées, de changements de plannings entraînant de longues et délicates traversées de chantiers ou de manque de planification des besoins en personnel dans certaines zones. Tous ces enseignements acquis au cours des premiers travaux devraient permettre de dégager des voies d'amélioration à mettre en place pour les prochains secteur...

  14. Are rapid population estimates accurate? A field trial of two different assessment methods.

    Science.gov (United States)

    Grais, Rebecca F; Coulombier, Denis; Ampuero, Julia; Lucas, Marcelino E S; Barretto, Avertino T; Jacquier, Guy; Diaz, Francisco; Balandine, Serge; Mahoudeau, Claude; Brown, Vincent

    2006-09-01

    Emergencies resulting in large-scale displacement often lead to populations resettling in areas where basic health services and sanitation are unavailable. To plan relief-related activities quickly, rapid population size estimates are needed. The currently recommended Quadrat method estimates total population by extrapolating the average population size living in square blocks of known area to the total site surface. An alternative approach, the T-Square, provides a population estimate based on analysis of the spatial distribution of housing units taken throughout a site. We field tested both methods and validated the results against a census in Esturro Bairro, Beira, Mozambique. Compared to the census (population: 9,479), the T-Square yielded a better population estimate (9,523) than the Quadrat method (7,681; 95% confidence interval: 6,160-9,201), but was more difficult for field survey teams to implement. Although applicable only to similar sites, several general conclusions can be drawn for emergency planning.

  15. Interval breast cancers in the 'screening with tomosynthesis or standard mammography' (STORM) population-based trial.

    Science.gov (United States)

    Houssami, Nehmat; Bernardi, Daniela; Caumo, Francesca; Brunelli, Silvia; Fantò, Carmine; Valentini, Marvi; Romanucci, Giovanna; Gentilini, Maria A; Zorzi, Manuel; Macaskill, Petra

    2018-04-01

    The prospective 'screening with tomosynthesis or standard mammography' (STORM) trial recruited women participating in biennial breast screening in Italy (2011-2012), and compared sequential screen-readings based on 2D-mammography alone or based on tomosynthesis (integrated 2D/3D-mammography). The STORM trial showed that tomosynthesis screen-reading significantly increased breast cancer detection compared to 2D-mammography alone. The present study completes reporting of the trial by examining interval breast cancers ascertained at two year follow-up. 9 interval breast cancers were identified; the estimated interval cancer rate was 1.23/1000 screens [9/7292] (95%CI 0.56 to 2.34) or 1.24/1000 negative screens [9/7235] (95%CI 0.57 to 2.36). In concurrently screened women who attended the same screening services and received 2D-mammography, interval cancer rate was 1.60/1000 screens [40/25,058] (95% CI 1.14 to 2.17) or 1.61/1000 negative screens [40/24,922] (95% CI 1.15 to 2.18). Estimated screening sensitivity for the STORM trial was 85.5% [59/69] (95%CI 75.0%-92.8%), and that for 2D-mammography screening was 77.3% [136/176] (95%CI 70.4%-83.2%). Interval breast cancer rate amongst screening participants in the STORM trial was marginally lower (and screening sensitivity higher) than estimates amongst 2D-screened women; these findings should be interpreted with caution given the small number of interval cases and the sample size of the trial. Much larger screening studies, or pooled analyses, are required to examine interval cancer rates arising after breast tomosynthesis screening versus digital mammography screening. Copyright © 2018 Elsevier Ltd. All rights reserved.

  16. Integrating smoking cessation and alcohol use treatment in homeless populations: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ojo-Fati, Olamide; John, Florence; Thomas, Janet; Joseph, Anne M; Raymond, Nancy C; Cooney, Ned L; Pratt, Rebekah; Rogers, Charles R; Everson-Rose, Susan A; Luo, Xianghua; Okuyemi, Kolawole S

    2015-08-29

    Despite progress in reducing cigarette smoking in the general U.S. population, smoking rates, cancer morbidity and related heart disease remain strikingly high among the poor and underserved. Homeless individuals' cigarette smoking rate remains an alarming 70% or greater, and this population is generally untreated with smoking cessation interventions. Furthermore, the majority of homeless smokers also abuse alcohol and other drugs, which makes quitting more difficult and magnifies the health consequences of tobacco use. Participants will be randomized to one of three groups, including (1) an integrated intensive smoking plus alcohol intervention using cognitive behavioral therapy (CBT), (2) intensive smoking intervention using CBT or (3) usual care (i.e., brief smoking cessation and brief alcohol counseling). All participants will receive 12-week treatment with a nicotine patch plus nicotine gum or lozenge. Counseling will include weekly individual sessions for 3 months, followed by monthly booster group sessions for 3 months. The primary smoking outcome is cotinine-verified 7-day smoking abstinence at follow-up week 52, and the primary alcohol outcome will be breathalyzer-verified 90-day alcohol abstinence at week 52. This study protocol describes the design of the first community-based controlled trial (n = 645) designed to examine the efficacy of integrating alcohol abuse treatment with smoking cessation among homeless smokers. To further address the gap in effectiveness of evidence-based smoking cessation interventions in the homeless population, we are conducting a renewed smoking cessation clinical trial called Power to Quit among smokers experiencing homelessness. ClinicalTrials.gov Identifier: NCT01932996. Date of registration: 20 November 2014.

  17. A Novel Mobile App and Population Management System to Manage Rheumatoid Arthritis Flares: Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Wang, Penny; Luo, Dee; Lu, Fengxin; Elias, Josephine S; Landman, Adam B; Michaud, Kaleb D; Lee, Yvonne C

    2018-04-11

    Rheumatoid arthritis flares have a profound effect on patients, causing pain and disability. However, flares often occur between regularly scheduled health care provider visits and are, therefore, difficult to monitor and manage. We sought to develop a mobile phone app combined with a population management system to help track RA flares between visits. The objective of this study is to implement the mobile app plus the population management system to monitor rheumatoid arthritis disease activity between scheduled health care provider visits over a period of 6 months. This is a randomized controlled trial that lasts for 6 months for each participant. We aim to recruit 190 patients, randomized 50:50 to the intervention group versus the control group. The intervention group will be assigned the mobile app and be prompted to answer daily questionnaires sent to their mobile devices. Both groups will be assigned a population manager, who will communicate with the participants via telephone at 6 weeks and 18 weeks. The population manager will also communicate with the participants in the intervention group if their responses indicate a sustained increase in rheumatoid arthritis disease activity. To assess patient satisfaction, the primary outcomes will be scores on the Treatment Satisfaction Questionnaire for Medication as well as the Perceived Efficacy in Patient-Physician Interactions questionnaire at 6 months. To determine the effect of the mobile app on rheumatoid arthritis disease activity, the primary outcome will be the Clinical Disease Activity Index at 6 months. The trial started in November 2016, and an estimated 2.5 years will be necessary to complete the study. Study results are expected to be published by the end of 2019. The completion of this study will provide important data regarding the following: (1) the assessment of validated outcome measures to assess rheumatoid arthritis disease activity with a mobile app between routinely scheduled health care

  18. The Development of a Communication Tool to Facilitate the Cancer Trial Recruitment Process and Increase Research Literacy among Underrepresented Populations.

    Science.gov (United States)

    Torres, Samantha; de la Riva, Erika E; Tom, Laura S; Clayman, Marla L; Taylor, Chirisse; Dong, Xinqi; Simon, Melissa A

    2015-12-01

    Despite increasing need to boost the recruitment of underrepresented populations into cancer trials and biobanking research, few tools exist for facilitating dialogue between researchers and potential research participants during the recruitment process. In this paper, we describe the initial processes of a user-centered design cycle to develop a standardized research communication tool prototype for enhancing research literacy among individuals from underrepresented populations considering enrollment in cancer research and biobanking studies. We present qualitative feedback and recommendations on the prototype's design and content from potential end users: five clinical trial recruiters and ten potential research participants recruited from an academic medical center. Participants were given the prototype (a set of laminated cards) and were asked to provide feedback about the tool's content, design elements, and word choices during semi-structured, in-person interviews. Results suggest that the prototype was well received by recruiters and patients alike. They favored the simplicity, lay language, and layout of the cards. They also noted areas for improvement, leading to card refinements that included the following: addressing additional topic areas, clarifying research processes, increasing the number of diverse images, and using alternative word choices. Our process for refining user interfaces and iterating content in early phases of design may inform future efforts to develop tools for use in clinical research or biobanking studies to increase research literacy.

  19. Les animateurs TICE du premier degré, quelle professionnalité ?

    OpenAIRE

    Villemonteix , François

    2007-01-01

    International audience; Les animateurs TICE du premier degré, quelle professionnalité ? Congrès international AREF 2007 (Actualité de la Recherche en Education et en Formation) François VILLEMONTEIX Doctorant Laboratoire EDA (Education et apprentissages) Université Paris 5 – La Sorbonne franç RÉSUMÉ. Dans le but de favoriser le développement d'usages instrumentés dans les classes de l'école primaire française, l'institution éducative a depuis les années 80 at...

  20. Are women who work in bars, guesthouses and similar facilities a suitable study population for vaginal microbicide trials in Africa?

    Directory of Open Access Journals (Sweden)

    Andrew Vallely

    2010-05-01

    Full Text Available A feasibility study was conducted to investigate whether an occupational at-risk cohort of women in Mwanza, Tanzania are a suitable study population for future phase III vaginal microbicide trials.1573 women aged 16-54 y working in traditional and modern bars, restaurants, hotels, guesthouses or as local food-handlers were enrolled at community-based reproductive health clinics, provided specimens for HIV/STI and pregnancy testing, and asked to attend three-monthly clinical follow-up visits for 12-months. HIV positive and negative women were eligible to enter the feasibility study and to receive free reproductive health services at any time. HIV prevalence at baseline was 26.5% (417/1573. HIV incidence among 1156 sero-negative women attending at baseline was 2.9/100PYs. Among 1020 HIV sero-negative, non-pregnant women, HIV incidence was 2.0/100PYs, HSV-2 incidence 12.7/100PYs and pregnancy rate 17.8/100PYs. Retention at three-months was 76.3% (778/1020. Among 771 HIV sero-negative, non-pregnant women attending at three-months, subsequent follow-up at 6, 9 and 12-months was 83.7%, 79.6%, and 72.1% respectively. Older women, those who had not moved home or changed their place of work in the last year, and women working in traditional bars or as local food handlers had the highest re-attendance.Women working in food outlets and recreational facilities in Tanzania and other parts of Africa may be a suitable study population for microbicide and other HIV prevention trials. Effective locally-appropriate strategies to address high pregnancy rates and early losses to follow-up are essential to minimise risk to clinical trials in these settings.

  1. Effect of Fee on Cervical Cancer Screening Attendance—ScreenFee, a Swedish Population-Based Randomised Trial

    Science.gov (United States)

    Alfonzo, Emilia; Andersson Ellström, Agneta; Nemes, Szilard; Strander, Björn

    2016-01-01

    Background Attendance in the cervical cancer screening programme is one of the most important factors to lower the risk of contracting the disease. Attendance rates are often low in areas with low socioeconomic status. Charging a fee for screening might possibly decrease attendance in this population. Screening programme coverage is low in low socio-economic status areas in Gothenburg, Sweden, but has increased slightly after multiple interventions in recent years. For many years, women in the region have paid a fee for screening. We studied the effect of abolishing this fee in a trial emanating from the regular cervical cancer screening programme. Method Individually randomised controlled trial. All 3 124 women in three low-resource areas in Gothenburg, due for screening during the study period, were randomised to receive an offer of a free test or the standard invitation stating the regular fee of 100 SEK (≈11 €). The study was conducted during the first six months of 2013. Attendance was defined as a registered Pap smear within 90 days from the date the invitation was sent out. Results Attendance did not differ significantly between women who were charged and those offered free screening (RR 0.93; CI 0.85–1.02). No differences were found within the districts or as an effect of age, attendance after the most recent previous invitation or previous experience of smear taking. Conclusion Abolishment of a modest screening fee in socially disadvantaged urban districts with low coverage, after previous multiple systematic interventions, does not increase attendance in the short term. Other interventions might be more important for increasing attendance in low socio-economic status areas. Trial Registration ClinicalTrials.gov NCT02378324 PMID:26986848

  2. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

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

  3. Prediction of black box warning by mining patterns of Convergent Focus Shift in clinical trial study populations using linked public data.

    Science.gov (United States)

    Ma, Handong; Weng, Chunhua

    2016-04-01

    To link public data resources for predicting post-marketing drug safety label changes by analyzing the Convergent Focus Shift patterns among drug testing trials. We identified 256 top-selling prescription drugs between 2003 and 2013 and divided them into 83 BBW drugs (drugs with at least one black box warning label) and 173 ROBUST drugs (drugs without any black box warning label) based on their FDA black box warning (BBW) records. We retrieved 7499 clinical trials that each had at least one of these drugs for intervention from the ClinicalTrials.gov. We stratified all the trials by pre-marketing or post-marketing status, study phase, and study start date. For each trial, we retrieved drug and disease concepts from clinical trial summaries to model its study population using medParser and SNOMED-CT. Convergent Focus Shift (CFS) pattern was calculated and used to assess the temporal changes in study populations from pre-marketing to post-marketing trials for each drug. Then we selected 68 candidate drugs, 18 with BBW warning and 50 without, that each had at least nine pre-marketing trials and nine post-marketing trials for predictive modeling. A random forest predictive model was developed to predict BBW acquisition incidents based on CFS patterns among these drugs. Pre- and post-marketing trials of BBW and ROBUST drugs were compared to look for their differences in CFS patterns. Among the 18 BBW drugs, we consistently observed that the post-marketing trials focused more on recruiting patients with medical conditions previously unconsidered in the pre-marketing trials. In contrast, among the 50 ROBUST drugs, the post-marketing trials involved a variety of medications for testing their associations with target intervention(s). We found it feasible to predict BBW acquisitions using different CFS patterns between the two groups of drugs. Our random forest predictor achieved an AUC of 0.77. We also demonstrated the feasibility of the predictor for identifying long

  4. ABOUT THE SMART SPORTS DEVELOPMENT. EVIDENCE FROM THE UK PREMIERE LEAGUE

    Directory of Open Access Journals (Sweden)

    Vlad Ionut Dumitrache

    2016-11-01

    Full Text Available Smart economy implies the development of key factors like global economy growth, competition, economic progress, economic prosperity, innovation. In the European top-level football, like the case of the British Premier League, financial indicators have demonstrated that the factors that define smart economy can be identified. The new rules of the financial fair-play policies and the ever growing revenues for television rights have created a new market in sports economy, one that identifies itself with the criteria identifies in studies regarding smart economy. This paper comparatively examines the determinants of four indicators of the football team quality in the British Premier League, in order to find out whether a common set of potential determinants could be effective in improving all four indicators of quality, without worsening any of them. This allows finding what measures undertaken at the level of football teams could raise the football team quality. Considering the subjective and multidimensional nature of the football team quality, we first propose four indicators that might be appropriate to define this latent summative measure. Then we select a number of four potentially common determinants of the football team quality, and finally discuss the empirical results, based on panel generalized least squares regression models. The television broadcasting rights are found to be the most important determinant of the football team quality.

  5. Asymmetry after hamstring injury in English Premier League: issue resolved, or perhaps not?

    Science.gov (United States)

    Barreira, P; Drust, B; Robinson, M A; Vanrenterghem, J

    2015-06-01

    Hamstring injuries constitute one of the most concerning injuries in English Premier League football, due to its high primary incidence but also its recurrence. Functional methods assessing hamstring function during high-risk performance tasks such as sprinting are vital to identify potential risk factors. The purpose of this study was to assess horizontal force deficits during maximum sprint running on a non-motorized treadmill in football players with previous history of hamstring strains as a pre-season risk-assessment in a club setting. 17 male football players from one Premier League Club were divided into 2 groups, experimental (n=6, age=24.5±2.3 years) and control (n=11, age=21.3±1.2 years), according to history of previous hamstring injury. Participants performed a protocol including a 10-s maximum sprint on a non-motorized treadmill. Force deficits during acceleration phase and steady state phases of the sprint were assessed between limbs and between groups. The main outcome measures were horizontal and vertical peak forces during the acceleration phase or steady state. There were no significant differences in peak forces between previously injured and non-injured limbs, or between groups, challenging the ideas around functional force deficits in sprint running as a diagnostic measure of hamstring re-injury risk. © Georg Thieme Verlag KG Stuttgart · New York.

  6. Football fans and food: a case study of a football club in the English premier league.

    Science.gov (United States)

    Ireland, Robin; Watkins, Francine

    2010-05-01

    Although there is growing awareness of the impact of diet on health, little attention has been given to the food available in our sports stadia. We used a football club (Citygrene FC) - Citygrene is a fictional name - in the English Premier League as a case study to examine the attitudes of male and female football supporters to the food and drink available at their home stadium (Citygrene Stadium). The research design used five focus groups of male and female fans. The discourse was audiotaped, transcribed, coded and analysed for themes. A football stadium in the English Premier League, England. The participants were season ticket holders drawn from two stands at Citygrene Stadium. The research showed a high level of dissatisfaction with the food and drink supplied. There were key differences in the views of the male and female participants in the focus groups, with the women more concerned about wider issues such as the lack of healthy food. Both men and women were aware of their role as consumers and felt that there was an opportunity for Citygrene to improve their catering profits, if they provided a better selection of food and drink and an improved service. The study shows that there is a demand for healthier food options (and a wider choice of food and drink in general), which may provide an economic opportunity for stadium and catering managers. In addition, a stadium may be considered a potential 'healthy setting', which can serve as a supportive environment for healthier food choices.

  7. Report to New England Governors and Eastern Canadian Premiers on climate change projects

    International Nuclear Information System (INIS)

    2002-08-01

    The Premiers-Governors energy discussions are aimed at promoting joint energy cooperation between provinces and states. This report outlines the major accomplishments in the implementation of the Climate Change Action Plan adopted by the Conference in 1998. The project priorities for the coming year are also outlined. In 2001, the New England Governors (NEG) and the Eastern Canadian Premiers (ECP) directed the Environment Committee and the Northeast International Committee on Energy (NICE) to implement a plan to develop a regional emissions inventory so that participating jurisdictions would have common data for measuring progress. The plan also identified specific climate actions that could be readily implemented. This report describes the results of 5 working groups which were created to focus on the following potential categories: energy, transportation, inventory and registry, adaptation, and 'lead by example'. In addition to the working groups, the Climate Change Steering Committee developed 4 proposals for consideration for implementation. These were the LED Traffic Light Proposal, the College and University Partnerships in Emissions Reductions, State/Provincial Purchasing Programs for High Efficiency-Low Emission Office Equipment, and Use of Cleaner, More Energy-Efficient Vehicles in State/Provincial Fleets. The Steering Committee will also pursue other tasks in the coming year, including the study of other proposals for cost-effective measures that could contribute to the goals of the Climate Change Action Plan, examine Internet options for coordinating internal project work, examine opportunities to pursue climate action, and identify opportunities to improve vehicle fuel efficiency

  8. Effect of Fee on Cervical Cancer Screening Attendance--ScreenFee, a Swedish Population-Based Randomised Trial.

    Science.gov (United States)

    Alfonzo, Emilia; Andersson Ellström, Agneta; Nemes, Szilard; Strander, Björn

    2016-01-01

    Attendance in the cervical cancer screening programme is one of the most important factors to lower the risk of contracting the disease. Attendance rates are often low in areas with low socioeconomic status. Charging a fee for screening might possibly decrease attendance in this population. Screening programme coverage is low in low socio-economic status areas in Gothenburg, Sweden, but has increased slightly after multiple interventions in recent years. For many years, women in the region have paid a fee for screening. We studied the effect of abolishing this fee in a trial emanating from the regular cervical cancer screening programme. Individually randomised controlled trial. All 3 124 women in three low-resource areas in Gothenburg, due for screening during the study period, were randomised to receive an offer of a free test or the standard invitation stating the regular fee of 100 SEK (≈11 €). The study was conducted during the first six months of 2013. Attendance was defined as a registered Pap smear within 90 days from the date the invitation was sent out. Attendance did not differ significantly between women who were charged and those offered free screening (RR 0.93; CI 0.85-1.02). No differences were found within the districts or as an effect of age, attendance after the most recent previous invitation or previous experience of smear taking. Abolishment of a modest screening fee in socially disadvantaged urban districts with low coverage, after previous multiple systematic interventions, does not increase attendance in the short term. Other interventions might be more important for increasing attendance in low socio-economic status areas. ClinicalTrials.gov NCT02378324.

  9. Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico

    Science.gov (United States)

    Cornejo Vucovich, Elsa; Ingram, Maia; Valenica, Celina; Castro Vasquez, Maria del Carmen; Gonzalez-Fagoaga, Eduardo; Geurnsey de Zapien, Jill

    2018-01-01

    Introduction Northern Mexico has among the highest rates of cardiovascular disease (CVD) and diabetes in the world. This research addresses core gaps in implementation science to develop, test and scale-up CVD risk-reduction interventions in diabetics through a national primary care health system. Methods and analysis The Meta Salud Diabetes (MSD) research project is a parallel two-arm cluster-randomised clinical behavioural trial based in 22 (n=22) health centres in Sonora, Mexico. MSD aims to evaluate the effectiveness of the MSD intervention for the secondary prevention of CVD risk factors among a diabetic population (n=320) compared with the study control of usual care. The MSD intervention consists of 2-hour class sessions delivered over a 13-week period providing educational information to encourage sustainable behavioural change to prevent disease complications including the adoption of physical activity. MSD is delivered within the context of Mexico’s national primary care health centre system by health professionals, including nurses, physicians and community health workers via existing social support groups for individuals diagnosed with chronic disease. Mixed models are used to estimate the effect of MSD by comparing cardiovascular risk, as measured by the Framingham Risk Score, between the trial arms. Secondary outcomes include hypertension, behavioural risk factors and psychosocial factors. Ethics and dissemination This work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (1R01HL125996-01) and approved by the University of Arizona Research Institutional Review Board (Protocol 1508040144) and the Research Bioethics Committee at the University of Sonora. The first Internal Review Board approval date was 31 August 2015 with five subsequent approved amendments. This article refers to protocol V.0.2, dated 30 January 2017. Results will be disseminated via peer-reviewed publication and presentation at

  10. How does a clinical trial fit into the real world? The RELAX-AHF study population into the EAHFE registry.

    Science.gov (United States)

    Miró, Òscar; Gil, Víctor; Müller, Christian; Mebazaa, Alexander; Bueno, Héctor; Martín-Sánchez, Francisco Javier; Herrero, Pablo; Jacob, Javier; Llorens, Pere

    2015-10-01

    To test how accurate the recently published RELAX-AHF trial was in recruiting real-world patients with acute-decompensated heart failure (ADHF). We compared clinical and outcome data of patients receiving serelaxin in the RELAX-AHF trial (RELAX group, n = 581) with patients included in the EAHFE registry [5497 ADHF from 29 Spanish emergency departments (EDs)]. The EAHFE registry was split into two groups: EAHFE-non-RELAX (patients not fulfilling the RELAX-AHF inclusion criteria; n = 3205, 58.3 %) and EAHFE-RELAX A (patients fulfilling RELAX-AHF inclusion criteria; n = 2292, 41.7 %). The latter group was further refined by also applying exclusion criteria (EAHFE-RELAX B; n = 964, 17.4 %). Both EAHFE-RELAX groups differed from the EAHFE-non-RELAX group in multiple aspects, with the lower the proportion of patients with implantable cardiac defibrillator and with pulmonary diseases the greater the differences found. The RELAX group, compared with the EAHFE-RELAX groups, significantly included fewer females, younger patients, less in NYHA class I/II, less with implantable cardiac defibrillator and on beta-blocker treatment, and patients had lower systolic blood pressure and cardiac and respiratory rates at ED arrival. The EAHFE-RELAX groups had a significantly lower all-cause mortality than EAHFE-non-RELAX group, and qualitative analysis suggested that EAHFE-RELAX groups had a higher mortality than the RELAX group. Patients included in the RELAX-AHF trial showed unanticipated differences when compared with a population from the EAHFE registry fulfilling very similar inclusion and exclusion criteria.

  11. Population-based versus practice-based recall for childhood immunizations: a randomized controlled comparative effectiveness trial.

    Science.gov (United States)

    Kempe, Allison; Saville, Alison; Dickinson, L Miriam; Eisert, Sheri; Reynolds, Joni; Herrero, Diana; Beaty, Brenda; Albright, Karen; Dibert, Eva; Koehler, Vicky; Lockhart, Steven; Calonge, Ned

    2013-06-01

    We compared the effectiveness and cost-effectiveness of population-based recall (Pop-recall) versus practice-based recall (PCP-recall) at increasing immunizations among preschool children. This cluster-randomized trial involved children aged 19 to 35 months needing immunizations in 8 rural and 6 urban Colorado counties. In Pop-recall counties, recall was conducted centrally using the Colorado Immunization Information System (CIIS). In PCP-recall counties, practices were invited to attend webinar training using CIIS and offered financial support for mailings. The percentage of up-to-date (UTD) and vaccine documentation were compared 6 months after recall. A mixed-effects model assessed the association between intervention and whether a child became UTD. Ten of 195 practices (5%) implemented recall in PCP-recall counties. Among children needing immunizations, 18.7% became UTD in Pop-recall versus 12.8% in PCP-recall counties (P immunization rates in preschool children.

  12. Population-centered Risk- and Evidence-based Dental Interprofessional Care Team (PREDICT): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Cunha-Cruz, Joana; Milgrom, Peter; Shirtcliff, R Michael; Bailit, Howard L; Huebner, Colleen E; Conrad, Douglas; Ludwig, Sharity; Mitchell, Melissa; Dysert, Jeanne; Allen, Gary; Scott, JoAnna; Mancl, Lloyd

    2015-06-20

    To improve the oral health of low-income children, innovations in dental delivery systems are needed, including community-based care, the use of expanded duty auxiliary dental personnel, capitation payments, and global budgets. This paper describes the protocol for PREDICT (Population-centered Risk- and Evidence-based Dental Interprofessional Care Team), an evaluation project to test the effectiveness of new delivery and payment systems for improving dental care and oral health. This is a parallel-group cluster randomized controlled trial. Fourteen rural Oregon counties with a publicly insured (Medicaid) population of 82,000 children (0 to 21 years old) and pregnant women served by a managed dental care organization are randomized into test and control counties. In the test intervention (PREDICT), allied dental personnel provide screening and preventive services in community settings and case managers serve as patient navigators to arrange referrals of children who need dentist services. The delivery system intervention is paired with a compensation system for high performance (pay-for-performance) with efficient performance monitoring. PREDICT focuses on the following: 1) identifying eligible children and gaining caregiver consent for services in community settings (for example, schools); 2) providing risk-based preventive and caries stabilization services efficiently at these settings; 3) providing curative care in dental clinics; and 4) incentivizing local delivery teams to meet performance benchmarks. In the control intervention, care is delivered in dental offices without performance incentives. The primary outcome is the prevalence of untreated dental caries. Other outcomes are related to process, structure and cost. Data are collected through patient and staff surveys, clinical examinations, and the review of health and administrative records. If effective, PREDICT is expected to substantially reduce disparities in dental care and oral health. PREDICT can be

  13. Closing the antidepressant efficacy gap between clinical trials and real patient populations.

    Science.gov (United States)

    Wade, Alan G

    2006-01-01

    Overall, patient outcomes in the primary care of depression are seldom as good as those achieved in clinical trials - the "efficacy gap". Many factors contribute to this, including poor patient compliance, poor family and social support and negative media reporting of antidepressants. Indeed, negative media reporting has had far more impact on physicians' prescribing of antidepressants than have regulatory agencies, partly as a result of changing public attitudes. Negative media reports linking SSRIs to increased child suicide rates have also resulted in a decline in the prescribing of SSRIs to this age group, but with no concomitant increase in the prescribing of fluoxetine, the only antidepressant recommended for the treatment of children. There are also inadequacies in the guidelines available to primary care givers that might contribute to the efficacy gap. Guidelines can be too specific for clinical practice - especially where depression coexists with anxiety disorders - and too passive, resulting in delayed or inadequate intervention. Evidence suggests that many physicians prefer to be more proactive. In the recent AHEAD survey, physicians identified faster resolution of symptoms as the property most desirable for improving antidepressant therapy. There is recent evidence that structured long-term therapy and easily-implemented measurement-based care procedures can improve remission rates and help bridge the efficacy gap. If these can be allied with greater public/media understanding of depression and its treatment, along with improved guidelines, then significant progress can be anticipated in the management of mood disorders.

  14. The Impact of Massage Therapy on Function in Pain Populations-A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part II, Cancer Pain Populations.

    Science.gov (United States)

    Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin

    2016-08-01

    Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of massage therapy research and evidence for its efficacy in treating pain, function-related and health-related quality of life in cancer populations. Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using the SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A diverse steering committee interpreted the results to develop recommendations. Twelve high quality and four low quality studies were subsequently included in the review. Results demonstrate massage therapy is effective for treating pain compared to no treatment [standardized mean difference (SMD)  = -.20] and active (SMD = -0.55) comparators. Compared to active comparators, massage therapy was also found to be beneficial for treating fatigue (SMD = -1.06) and anxiety (SMD = -1.24). Based on the evidence, weak recommendations are suggested for massage therapy, compared to an active comparator, for the treatment of pain, fatigue, and anxiety. No recommendations were suggested for massage therapy compared to no treatment or sham control based on the available literature to date. This review addresses massage therapy safety, research challenges, how to address identified research gaps, and necessary next steps for implementing massage therapy as a viable pain management option for cancer pain populations. © 2016 American Academy of Pain Medicine.

  15. Randomized Trial of a Family-based, Automated, Conversational Obesity Treatment Program for Underserved Populations

    Science.gov (United States)

    Wright, J. A.; Phillips, B.D.; Watson, B.L.; Newby, P.K.; Norman, G. J.; Adams, W.G.

    2013-01-01

    Objective To evaluate the acceptability and feasibility of a scalable obesity treatment program integrated with pediatric primary care and delivered using interactive voice technology (IVR) to families from underserved populations. Design and Methods Fifty parent-child dyads (child 9–12 yrs, BMI >95th percentile) were recruited from a pediatric primary care clinic and randomized to either an IVR or a wait-list control (WLC) group. The majority were lower-income, African-American (72%) families. Dyads received IVR calls for 12 weeks. Call content was informed by two evidenced-based interventions. Anthropometric and behavioral variables were assessed at baseline and 3 mo follow-up. Results Forty-three dyads completed the study. IVR parents ate 1 cup more fruit than WLC (p 75% agreed that the calls were useful, made for people like them, credible, and helped them eat healthy foods. Conclusion An obesity treatment program delivered via IVR may be an acceptable and feasible resource for families from underserved populations. PMID:23512915

  16. The Impact of Massage Therapy on Function in Pain Populations-A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part III, Surgical Pain Populations.

    Science.gov (United States)

    Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin

    2016-09-01

    Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of the evidence for massage therapy's efficacy in treating pain, function-related, and health-related quality of life outcomes in surgical pain populations. Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A professionally diverse steering committee interpreted the results to develop recommendations. Twelve high quality and four low quality studies were included in the review. Results indicate massage therapy is effective for treating pain [standardized mean difference (SMD) = -0.79] and anxiety (SMD = -0.57) compared to active comparators. Based on the available evidence, weak recommendations are suggested for massage therapy, compared to active comparators for reducing pain intensity/severity and anxiety in patients undergoing surgical procedures. This review also discusses massage therapy safety, challenges within this research field, how to address identified research gaps, and next steps for future research. © 2016 American Academy of Pain Medicine.

  17. How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania

    Directory of Open Access Journals (Sweden)

    Kavit Natujwa

    2010-06-01

    Full Text Available Abstract Background HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania. Methods A total of 1146 women at increased risk of HIV acquisition working as alcohol and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate women's perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews (IDIs conducted immediately after their 4, 24 and 52 week follow-up visits. Results 99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks (a total of 256 interviews. In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy. Conclusions

  18. Evaluation of the Prostate Cancer Prevention Trial Risk Calculator in a High-Risk Screening Population

    Science.gov (United States)

    Kaplan, David J.; Boorjian, Stephen A.; Ruth, Karen; Egleston, Brian L.; Chen, David Y.T.; Viterbo, Rosalia; Uzzo, Robert G.; Buyyounouski, Mark K.; Raysor, Susan; Giri, Veda N.

    2009-01-01

    Introduction Clinical factors in addition to PSA have been evaluated to improve risk assessment for prostate cancer. The Prostate Cancer Prevention Trial (PCPT) risk calculator provides an assessment of prostate cancer risk based on age, PSA, race, prior biopsy, and family history. This study evaluated the risk calculator in a screening cohort of young, racially diverse, high-risk men with a low baseline PSA enrolled in the Prostate Cancer Risk Assessment Program. Patients and Methods Eligibility for PRAP include men ages 35-69 who are African-American, have a family history of prostate cancer, or have a known BRCA1/2 mutation. PCPT risk scores were determined for PRAP participants, and were compared to observed prostate cancer rates. Results 624 participants were evaluated, including 382 (61.2%) African-American men and 375 (60%) men with a family history of prostate cancer. Median age was 49.0 years (range 34.0-69.0), and median PSA was 0.9 (range 0.1-27.2). PCPT risk score correlated with prostate cancer diagnosis, as the median baseline risk score in patients diagnosed with prostate cancer was 31.3%, versus 14.2% in patients not diagnosed with prostate cancer (p<0.0001). The PCPT calculator similarly stratified the risk of diagnosis of Gleason score ≥7 disease, as the median risk score was 36.2% in patients diagnosed with Gleason ≥7 prostate cancer versus 15.2% in all other participants (p<0.0001). Conclusion PCPT risk calculator score was found to stratify prostate cancer risk in a cohort of young, primarily African-American men with a low baseline PSA. These results support further evaluation of this predictive tool for prostate cancer risk assessment in high-risk men. PMID:19709072

  19. Une forme urbaine du premier âge touristique: les promenades littorales

    Directory of Open Access Journals (Sweden)

    Franck DEBIÉ

    1993-03-01

    Full Text Available Les promenades maritimes caractérisent les stations de bord de mer du premier âge touristique (1850-1930. Elles traduisent dans le paysage un urbanisme spéculatif, à rapprocher de celui qui produit le square et le boulevard, et donnent lieu à une urbanisation du littoral sous forme de vastes appendices linéaires. Les pratiques sociales associées à la promenade rappellent celles du jardin de plaisir, et renvoient au même rêve d’une urbanité idéale, libérée des miasmes, des promiscuités sociales, des contraintes qui pèsent sur les amours et les jeux.

  20. What’s a Cricketer’s Worth? Predicting Bid Prices for Indian Premier League Auctions

    Directory of Open Access Journals (Sweden)

    Siddhartha K. RASTOGI

    2017-04-01

    Full Text Available Indian Premier League is a twenty-over format cricket tournament of teams representing different Indian cities. Beginning 2008, it is established now as a grand annual affair. The team franchises are auctioned on long term basis, whereas cricketers are auctioned every season under certain conditions. Despite such wealth of information, studies on IPL auctions are rare barring four cited models. The present paper studies the results of year 2011 English-style auction of cricketers and recalibrates the old yet most accurate model by Rastogi and Deodhar (2009. Both models use ordinary least square method of regression albeit with different variable. The old models lack predictive power, whereas the recalibrated model presented displays better predictive capability as compared to earlier models. It also succeeds in reducing overall predictability gap and stands significantly parsimonious vis-à-vis previous models. Further, the final model presented is applied on 2013 and 2014 auction data to show superior results.

  1. Clinical Trials

    Medline Plus

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

  2. ENVIRONMENTAL TECHNOLOGY VERIFICATION REPORT - PHYSICAL REMOVAL OF MICROBIAL CONTAMINATION AGENTS IN DRINKING WATER, WATTS P{REMIER ULTRA 5 REVERSE OSMOSIS DRINKING WATER TREATMENT SYSTEM (POU)

    Science.gov (United States)

    The Watts Premier Ultra 5 system was tested for removal of bacteria and viruses at NSF International's Laboratory. Watts Premier submitted ten units, which were split into two groups of five. One group received 25 days of conditioning prior to challenge testing, while the secon...

  3. ETV REPORT: REMOVAL OF CHEMICAL CONTAMINANTS IN DRINKING WATER – WATTS PREMIER INC. WP-4V DRINKING WATER TREATMENT SYSTEM

    Science.gov (United States)

    The Watts Premier WP-4V POU drinking water treatment system was tested for removal of aldicarb, benzene, cadmium, carbofuran, cesium, chloroform, dichlorvos, dicrotophos, fenamiphos, mercury, mevinphos, oxamyl, strontium, and strychnine. The WP-4V employs a reverse osmosis (RO) m...

  4. The effect of playing formation on high-intensity running and technical profiles in English FA Premier League soccer matches

    DEFF Research Database (Denmark)

    Bradley, Paul S; Carling, Chris; Archer, Dave

    2011-01-01

    The aim of this study was to examine the effect of playing formation on high-intensity running and technical performance during elite soccer matches. Twenty English FA Premier League games were analysed using a multiple-camera computerized tracking system (n = 153 players). Overall ball possession...

  5. [Sõltumatu Tantsu Ühenduse poolt korraldatud sarjast "Premiere"] / Evelin Lagle ; küsinud Tambet Kaugema

    Index Scriptorium Estoniae

    Lagle, Evelin, 1986-

    2012-01-01

    Uutele koreograafidele pühendatud sarja "Premiere" programmis osalevad tantsulavastustega neli tantsukunstnikku Eestist - Tallinna Ülikooli lõpetanud Svetlana Grigorjeva, Turu Kunstiakadeemia lõpetanud Kaisa Selde, Viljandi Kultuuriakadeemia lõpetanud Kristina-Maria Heinsalu ja Tallinna Ülikooli lõpetanud Christin Lunts

  6. Disease activity, physical function, and radiographic progression after longterm therapy with adalimumab plus methotrexate: 5-year results of PREMIER

    NARCIS (Netherlands)

    van der Heijde, Désirée; Breedveld, Ferdinand C.; Kavanaugh, Arthur; Keystone, Edward C.; Landewé, Robert; Patra, Kaushik; Pangan, Aileen L.

    2010-01-01

    To evaluate the efficacy and safety of initial combination treatment with adalimumab (ADA) and methotrexate (MTX) versus monotherapy with ADA or MTX during an open-label extension of PREMIER. Patients with early rheumatoid arthritis (RA) received blinded ADA plus MTX, ADA alone, or MTX alone for 2

  7. Qualitative Impact Assessment 2010: An Independent Study Conducted by BDRC Continental, Ltd., February-July 2010. Premier League Reading Stars

    Science.gov (United States)

    National Literacy Trust, 2010

    2010-01-01

    Premier League Reading Stars (PLRS) is in its eighth year. To complement a pre-post quantitative survey, an impact evidence base was required to inform consideration of continued funding into 2011 and beyond. PLRS is very highly regarded among child participants, parents, and librarians. The structure of the scheme, its basis on football, and the…

  8. Gamified physical activation of young men – a Multidisciplinary Population-Based Randomized Controlled Trial (MOPO study

    Directory of Open Access Journals (Sweden)

    Ahola Riikka

    2013-01-01

    for activating young men can provide a translational model for community use. It can also be utilized as such or tailored to other selected populations or age groups. Trial registration ClinicalTrials.gov Identifier: NCT01376986

  9. Performance of breast cancer screening using digital breast tomosynthesis: results from the prospective population-based Oslo Tomosynthesis Screening Trial.

    Science.gov (United States)

    Skaane, Per; Sebuødegård, Sofie; Bandos, Andriy I; Gur, David; Østerås, Bjørn Helge; Gullien, Randi; Hofvind, Solveig

    2018-02-10

    Digital breast tomosynthesis (DBT) has the potential to overcome limitations of conventional mammography. This study investigated the effects of addition of DBT on interval and detected cancers in population-based screening. Oslo Tomosynthesis Screening Trial (OTST) was a prospective, independent double-reading trial inviting women 50-69 years biennially, comparing full-field digital mammography (FFDM) plus DBT with FFDM alone. Performance indicators and characteristics of screen-detected and interval cancers were compared with two previous FFDM rounds. 24,301 consenting women underwent FFDM + DBT screening over a 2-year period. Results were compared with 59,877 FFDM examinations during prior rounds. Addition of DBT resulted in a non-significant increase in sensitivity (76.2%, 378/496, vs. 80.8%, 227/281, p = 0.151) and a significant increase in specificity (96.4%, 57229/59381 vs. 97.5%, 23427/24020, p < .001). Number of recalls per screen-detected cancer decreased from 6.7 (2530/378) to 3.6 (820/227) with DBT (p < .001). Cancer detection per 1000 women screened increased (6.3, 378/59877, vs. 9.3, 227/24301, p < .001). Interval cancer rate per 1000 screens for FFDM + DBT remained similar to previous FFDM rounds (2.1, 51/24301 vs. 2.0, 118/59877, p = 0.734). Interval cancers post-DBT were comparable to prior rounds but significantly different in size, grade, and node status from cancers detected only using DBT. 39.6% (19/48) of interval cancers had positive nodes compared with only 3.9% (2/51) of additional DBT-only-detected cancers. DBT-supplemented screening resulted in significant increases in screen-detected cancers and specificity. However, no significant change was observed in the rate, size, node status, or grade of interval cancers. ClinicalTrials.gov: NCT01248546.

  10. Screening for type 2 diabetes in a high-risk population: study design and feasibility of a population-based randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Klijs Bart

    2012-08-01

    cardiovascular disease. Continuation of the large-scale RCT is warranted to test the hypothesis that targeted population-based screening for type 2 diabetes leads to a significant reduction in cardiovascular morbidity and mortality. Trial registration ISRCTN75983009

  11. Reduced dietary sodium intake increases heart rate. A meta-analysis of 63 randomized controlled trials including 72 study populations.

    Directory of Open Access Journals (Sweden)

    Niels eGraudal

    2016-03-01

    Full Text Available Reduced dietary sodium intake (sodium reduction increases heart rate in some studies of animals and humans. As heart rate is independently associated with the development of heart failure and increased risk of premature death a potential increase in heart rate could be a harmful side-effect of sodium reduction. The purpose of the present meta-analysis was to investigate the effect of sodium reduction on heart rate. Relevant studies were retrieved from an updated pool of 176 randomized controlled trials (RCTs published in the period 1973–2014. 63 of the RCTs including 72 study populations reported data on heart rate. In a meta-analysis of these data sodium reduction increased heart rate with 1.65 beats per minute [95% CI: 1.19, 2.11], p < 0.00001, corresponding to 2.4% of the baseline heart rate. This effect was independent of baseline blood pressure. In conclusion sodium reduction increases heart rate by as much (2.4% as it decreases blood pressure (2.5%. This side-effect, which may cause harmful health effects, contributes to the need for a revision of the present dietary guidelines.

  12. Effectiveness of an annular closure device in a "real-world" population: stratification of registry data using screening criteria from a randomized controlled trial.

    Science.gov (United States)

    Kuršumović, Adisa; Rath, Stefan A

    2018-01-01

    Increased focus has been put on the use of "'real-world" data to support randomized clinical trial (RCT) evidence for clinical decision-making. The objective of this study was to assess the performance of an annular closure device (ACD) after stratifying a consecutive series of "real-world" patients by the screening criteria of an ongoing RCT. This was a single-center registry analysis of 164 subjects who underwent limited discectomy combined with ACD for symptomatic lumbar disc herniation. Patients were stratified into two groups using the selection criteria of a pivotal RCT on the same device: Trial (met inclusion; n=44) or non-Trial (did not meet inclusion; n=120). Patient-reported outcomes, including Oswestry Disability Index (ODI) and visual analog scale (VAS) for leg and back pain, and adverse events were collected from baseline to last follow-up (mean: Trial - 15.6 months; non-Trial - 14.6 months). Statistical analyses were performed with significance set at p population. Stratification of this "real-world" series on the basis of RCT screening criteria did not result in significant between-group differences. These findings suggest that the efficacy of the ACD extends beyond the strictly defined patient population being studied in the RCT of this device. Furthermore, reducing the reherniation rate following lumbar discectomy has positive clinical and economic implications.

  13. Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico.

    Science.gov (United States)

    Sabo, Samantha; Denman Champion, Catalina; Bell, Melanie L; Cornejo Vucovich, Elsa; Ingram, Maia; Valenica, Celina; Castro Vasquez, Maria Del Carmen; Gonzalez-Fagoaga, Eduardo; Geurnsey de Zapien, Jill; Rosales, Cecilia B

    2018-03-12

    Northern Mexico has among the highest rates of cardiovascular disease (CVD) and diabetes in the world. This research addresses core gaps in implementation science to develop, test and scale-up CVD risk-reduction interventions in diabetics through a national primary care health system. The Meta Salud Diabetes (MSD) research project is a parallel two-arm cluster-randomised clinical behavioural trial based in 22 (n=22) health centres in Sonora, Mexico. MSD aims to evaluate the effectiveness of the MSD intervention for the secondary prevention of CVD risk factors among a diabetic population (n=320) compared with the study control of usual care. The MSD intervention consists of 2-hour class sessions delivered over a 13-week period providing educational information to encourage sustainable behavioural change to prevent disease complications including the adoption of physical activity. MSD is delivered within the context of Mexico's national primary care health centre system by health professionals, including nurses, physicians and community health workers via existing social support groups for individuals diagnosed with chronic disease. Mixed models are used to estimate the effect of MSD by comparing cardiovascular risk, as measured by the Framingham Risk Score, between the trial arms. Secondary outcomes include hypertension, behavioural risk factors and psychosocial factors. This work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (1R01HL125996-01) and approved by the University of Arizona Research Institutional Review Board (Protocol 1508040144) and the Research Bioethics Committee at the University of Sonora. The first Internal Review Board approval date was 31 August 2015 with five subsequent approved amendments. This article refers to protocol V.0.2, dated 30 January 2017. Results will be disseminated via peer-reviewed publication and presentation at international conferences and will be shared through meetings with health

  14. Associated chemical and carbon isotopic composition variations in diamonds from Finsch and Premier kimberlite, South Africa

    International Nuclear Information System (INIS)

    Deines, P.

    1984-01-01

    The carbon isotopic composition of 66 inclusion-containing diamonds from the Premier kimberlite, South Africa, 93 inclusion-containing diamonds and four diamonds of two diamond-bearing peridotite xenoliths from the Finsch kimberlite, South Africa was measured. The data suggest a relationship between the carbon isotopic composition of the diamonds and the chemical composition of the associated silicates. For both kimberlites similar trends are noted for diamonds containing peridotite-suite inclusions (P-type) and for diamonds containing eclogite-suite inclusions (E-type): Higher delta 13 C P-type diamonds tend to have inclusions lower in SiO 2 , Al 2 O 3 , Cr 2 O 3 , MgO, Mg/(Mg + Fe) and higher in FeO and CaO. Higher delta 13 C E-type diamonds tend to have inclusions lower in SiO 2 , Al 2 O 3 , MgO, Mg/(Mg + Fe), Na 2 O, K 2 O, TiO 2 and higher in CaO, Ca/(Ca + Mg). Consideration of a number of different models that have been proposed for the genesis of kimberlites, their zenoliths and diamonds shows that they are all consistent with the conclusion that in the mantle, regions exist that are characterized by different mean carbon isotopic compositions. (author)

  15. Linear systems surviving the first breakdown; Systemes unbaires survivant a la premiere panne

    Energy Technology Data Exchange (ETDEWEB)

    Uberschlag, J [Commissariat a l' Energie Atomique, Saclay (France). Centre d' Etudes Nucleaires

    1967-07-01

    Various types of linear systems are described which are not affected by the first breakdown. They make it possible to operate continuously and are thus very reliable. This is because the first breakdown which occurs affects only very slightly the operation. These components can be replaced during working. The operation, the errors, and the detection are briefly considered in the case of three different designs of linear servo systems. An attempt at comparison is made, it could be developed in a particular case. (author) [French] On decrit divers types de systemes lineaires survivant a la premiere panne. Ils permettent un fonctionnement permanent et sont donc d'une tres grande fiabilite. En effet, une panne, qui peut etre signalee, perturbe peu le fonctionnement. Ces composants peuvent etre remplaces en marche. Les considerations de fonctionnement, d'erreur, de detection des pannes sont succinctement presentees, sur trois schemas de systemes lineaires asservis. Une tentative de comparaison est faite, qui pourrait etre developpee dans des cas precis. (auteur)

  16. Trace elements in diamonds from the Premier, Finsch, and Jagersfontein mines, and their petrogenetic significance

    International Nuclear Information System (INIS)

    Fesq, H.W.; Bibby, D.M.; Erasmus, C.S.; Kable, E.J.D.

    1975-01-01

    Neutron-activation studies of the impurity chemistry of more than 1500 natural diamonds from three South African kimberlite sources, Premier, Finsch, and Jagersfontein, provide evidence for the presence of submicroscopic inclusions of a quenched (or temperature re-equilibrated) melt from which these diamonds crystallized. These microscopic inclusions of parental magma contain variable amounts of fluids rich in water and carbon dioxide, as well as iron-nickelcopper-cobalt sulphides, and a major silicate phase, which is remarkably constant in composition irrespective of the source of the diamonds and the age of emplacement of their host kimberlite. These microscopic inclusions are present in varying amounts in all the diamonds that were analysed, and may even dominate the impurity chemistry of diamonds having observable mineral inclusions. An estimate of the composition of the major elements in the silicate melt indicates that the diamonds that were investigated crystallized from picritic magma rich in water and carbon dioxide in the presence of immiscible iron-nickel-copper-cobalt sulphides [af

  17. Design science research for decision support systems development: recent publication trends in the premier IS journals

    Directory of Open Access Journals (Sweden)

    Shah J Miah

    2016-11-01

    Full Text Available This paper presents a contemporary literature review of design science research (DSR studies in the domain of decision support systems (DSS development. The latest studies in the DSS design domain claim that DSR methodologies are the most popular design approach, but many details are still yet to be revealed for supporting this claim. In particular, it is important to thoroughly investigate the trends in either the form or deeper insights in use of DSR in this field. The aim of this study is to analyse the existing DSS design science studies to reveal insights into the use of DSR, so that we can outline research agenda for a special issue, based on findings of analysis. We selected articles (from 2005 to 2014 that were published in seven selected premier IS journals (ranked as A* in the ABDC journal ranking. The selected 57 sample articles are representative of DSS design studies that used DSR in theorising, designing, implementing, and evaluating DSS solutions. We discuss the theoretical positions of DSR for DSS development through six categories: DSS artefacts, DSR methods, DSR views, user involvement, DSS design innovations and problem domains. The findings indicate that new studies are needed to fill the knowledge gap in DSS design science, for more solid theoretical basis in near future.

  18. Examining behavioral processes through which lifestyle interventions promote weight loss: results from PREMIER.

    Science.gov (United States)

    Fitzpatrick, Stephanie L; Bandeen-Roche, Karen; Stevens, Victor J; Coughlin, Janelle W; Rubin, Richard R; Brantley, Phillip J; Funk, Kristine L; Svetkey, Laura P; Jerome, Gerald J; Dalcin, Arlene; Charleston, Jeanne; Appel, Lawrence J

    2014-04-01

    To examine the behavioral processes through which lifestyle interventions impacted weight loss. The analyses were limited to overweight and obese Black and White adults randomized to a PREMIER lifestyle intervention (N = 501). Structural equation modeling was conducted to test the direct and indirect relationships of session attendance, days of self-monitoring diet and exercise, change in diet composition and exercise, and 6-month weight change. Greater session attendance was associated with increased self-monitoring, which was in turn significantly related to reduction in percent energy from total fat consumed. Change in percent energy from fat and self-monitoring was associated with 6-month percent change in weight. Both a decrease in fat intake and increase in self-monitoring are potential mediators of the relationship between attendance and weight change. The findings provide a reasonable model that suggests regular session attendance and use of behavioral strategies like self-monitoring are associated with improved behavioral outcomes that are associated with weight loss. Copyright © 2013 The Obesity Society.

  19. Predicting Football Matches Results using Bayesian Networks for English Premier League (EPL)

    Science.gov (United States)

    Razali, Nazim; Mustapha, Aida; Yatim, Faiz Ahmad; Aziz, Ruhaya Ab

    2017-08-01

    The issues of modeling asscoiation football prediction model has become increasingly popular in the last few years and many different approaches of prediction models have been proposed with the point of evaluating the attributes that lead a football team to lose, draw or win the match. There are three types of approaches has been considered for predicting football matches results which include statistical approaches, machine learning approaches and Bayesian approaches. Lately, many studies regarding football prediction models has been produced using Bayesian approaches. This paper proposes a Bayesian Networks (BNs) to predict the results of football matches in term of home win (H), away win (A) and draw (D). The English Premier League (EPL) for three seasons of 2010-2011, 2011-2012 and 2012-2013 has been selected and reviewed. K-fold cross validation has been used for testing the accuracy of prediction model. The required information about the football data is sourced from a legitimate site at http://www.football-data.co.uk. BNs achieved predictive accuracy of 75.09% in average across three seasons. It is hoped that the results could be used as the benchmark output for future research in predicting football matches results.

  20. Daily Distribution of Macronutrient Intakes of Professional Soccer Players From the English Premier League.

    Science.gov (United States)

    Anderson, Liam; Naughton, Robert J; Close, Graeme L; Di Michele, Rocco; Morgans, Ryland; Drust, Barry; Morton, James P

    2017-12-01

    The daily distribution of macronutrient intake can modulate aspects of training adaptations, performance and recovery. We therefore assessed the daily distribution of macronutrient intake (as assessed using food diaries supported by the remote food photographic method and 24-hr recalls) of professional soccer players (n = 6) of the English Premier League during a 7-day period consisting of two match days and five training days. On match days, average carbohydrate (CHO) content of the prematch (recovery from an evening kick-off) were similar (p > .05) though such intakes were lower than contemporary guidelines considered optimal for prematch CHO intake and postmatch recovery. On training days, we observed a skewed and hierarchical approach (p lunch (0.6 g·kg -1 )>breakfast (0.3 g·kg -1 )>evening snacks (0.1 g·kg -1 ). We conclude players may benefit from consuming greater amounts of CHO in both the prematch and postmatch meals so as to increase CHO availability and maximize rates of muscle glycogen resynthesis, respectively. Furthermore, attention should also be given to ensuring even daily distribution of protein intake so as to potentially promote components of training adaptation.

  1. Evaluation of sports nutrition knowledge of New Zealand premier club rugby coaches.

    Science.gov (United States)

    Zinn, Caryn; Schofield, Grant; Wall, Clare

    2006-04-01

    Little is known about if and how team coaches disseminate nutrition information to athletes. In a census survey, New Zealand premier rugby coaches (n = 168) completed a psychometrically validated questionnaire, received by either Internet or standard mail (response rate, 46%), identifying their nutrition advice dissemination practices to players, their level of nutrition knowledge, and the factors determining this level of knowledge. The majority of coaches provided advice to their players (83.8%). Coaches responded correctly to 55.6% of all knowledge questions. An independent t-test showed coaches who imparted nutrition advice obtained a significantly greater score, 56.8%, than those not imparting advice, 48.4% (P = 0.008). One-way ANOVA showed significant relationships between total knowledge score of all coaches and qualifications [F(1,166) = 5.28, P = 0.001], own knowledge rating [F(3,164) = 6.88, P = 0.001] and nutrition training [F(1,166) = 9.83, P = 0.002]. We conclude that these rugby coaches were inadequately prepared to impart nutrition advice to athletes and could benefit from further nutrition training.

  2. Technical Performance Analysis of Iran Premier League Soccer Players in 2012-2013 Season

    Directory of Open Access Journals (Sweden)

    Javani Mohsen

    2015-10-01

    Full Text Available Background and purpose of study : analysis of IRAN premier league soccer players’ technical performance in season 2012-2013, using a computerized match analysis system (Borhan Mobin Development Management Co, IRAN. Material and methods: in this study, data were obtained from 120 players, who performed in competitions 90 minutes. The players were classified into 3 positional roles: defenders, midfielders and forwards. Technical performance variables analysis included: total passes, total successful passes, pass accuracy, total shots; total shots to target, shot accuracy, ball interception and ball losses. The data were statistically analyzed by one-way ANOVA, Kruskal-Wallis, Mann-Whitney U and Tukey post hoc test. Results : The findings of this study showed that players performed about 45 passes per competition. Midfielders and defenders had significantly higher number of passes than forwards. Pass accuracy was about 67% and there were no significant differences between positional roles. Also, the players performed about 0.8 shots per competition, forwards and midfielders had significantly higher number of shots than defenders. Shot accuracy was about 31%; midfielders and forwards had significantly higher shot accuracy than defenders. Forwards showed significantly lower ball interception and higher ball losses than other positions. Conclusion : The result of this study showed that there were significant differences between some technical actions in positional roles. Therefore, coaches can use this information for individualization of training according to playing positions and for optimization of training in the amateur game.

  3. Intensive versus conventional blood pressure monitoring in a general practice population. The Blood Pressure Reduction in Danish General Practice trial: a randomized controlled parallel group trial

    DEFF Research Database (Denmark)

    Klarskov, Pia; Bang, Lia E; Schultz-Larsen, Peter

    2018-01-01

    To compare the effect of a conventional to an intensive blood pressure monitoring regimen on blood pressure in hypertensive patients in the general practice setting. Randomized controlled parallel group trial with 12-month follow-up. One hundred and ten general practices in all regions of Denmark....... One thousand forty-eight patients with essential hypertension. Conventional blood pressure monitoring ('usual group') continued usual ad hoc blood pressure monitoring by office blood pressure measurements, while intensive blood pressure monitoring ('intensive group') supplemented this with frequent...... a reduction of blood pressure. Clinical Trials NCT00244660....

  4. Gamified physical activation of young men--a Multidisciplinary Population-Based Randomized Controlled Trial (MOPO study).

    Science.gov (United States)

    Ahola, Riikka; Pyky, Riitta; Jämsä, Timo; Mäntysaari, Matti; Koskimäki, Heli; Ikäheimo, Tiina M; Huotari, Maija-Leena; Röning, Juha; Heikkinen, Hannu I; Korpelainen, Raija

    2013-01-14

    use. It can also be utilized as such or tailored to other selected populations or age groups. ClinicalTrials.gov Identifier: NCT01376986.

  5. Genetic diversity of symbiotic Bradyrhizobium elkanii populations recovered from inoculated and non-inoculated Acacia mangium field trials in Brazil.

    Science.gov (United States)

    Perrineau, M M; Le Roux, C; de Faria, S M; de Carvalho Balieiro, F; Galiana, A; Prin, Y; Béna, G

    2011-07-01

    Acacia mangium is a legume tree native to Australasia. Since the eighties, it has been introduced into many tropical countries, especially in a context of industrial plantations. Many field trials have been set up to test the effects of controlled inoculation with selected symbiotic bacteria versus natural colonization with indigenous strains. In the introduction areas, A. mangium trees spontaneously nodulate with local and often ineffective bacteria. When inoculated, the persistence of inoculants and possible genetic recombination with local strains remain to be explored. The aim of this study was to describe the genetic diversity of bacteria spontaneously nodulating A. mangium in Brazil and to evaluate the persistence of selected strains used as inoculants. Three different sites, several hundred kilometers apart, were studied, with inoculated and non-inoculated plots in two of them. Seventy-nine strains were isolated from nodules and sequenced on three housekeeping genes (glnII, dnaK and recA) and one symbiotic gene (nodA). All but one of the strains belonged to the Bradyrhizobium elkanii species. A single case of housekeeping gene transfer was detected among the 79 strains, suggesting an extremely low rate of recombination within B. elkanii, whereas the nodulation gene nodA was found to be frequently transferred. The fate of the inoculant strains varied depending on the site, with a complete disappearance in one case, and persistence in another. We compared our results with the sister species Bradyrhizobium japonicum, both in terms of population genetics and inoculant strain destiny. Copyright © 2011 Elsevier GmbH. All rights reserved.

  6. The Effect of EMDR and CBT on Low Self-esteem in a General Psychiatric Population: A Randomized Controlled Trial.

    Science.gov (United States)

    Griffioen, Brecht T; van der Vegt, Anna A; de Groot, Izaäk W; de Jongh, Ad

    2017-01-01

    Although low self-esteem has been found to be an important factor in the development and maintenance of psychopathology, surprisingly little is known about its treatment. This study investigated the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) therapy and Cognitive Behavioural Therapy (CBT), regarding their capacities in enhancing self-esteem in a general psychiatric secondary health care population. A randomized controlled trial with two parallel groups was used. Participants were randomly allocated to either 10 weekly sessions of EMDR ( n = 15) or CBT ( n = 15). They were assessed pre-treatment, after each session, post treatment and at 3 months follow-up on self-esteem (Rosenberg Self-esteem Scale and Credibility of Core Beliefs), psychological symptoms (Brief Symptom Inventory), social anxiety, and social interaction (Inventory of Interpersonal Situations) (IIS). The data were analyzed using repeated measures ANOVA for the complete cases ( n = 19) and intention-to-treat ( n = 30) to examine differences over time and between conditions. Both groups, EMDR as well as CBT, showed significant improvements on self-esteem, increasing two standard deviations on the main parameter (RSES). Furthermore, the results showed significant reductions in general psychiatric symptoms. The effects were maintained at 3 months follow-up. No between-group differences could be detected. Although the small sample requires to exercise caution in the interpretation of the findings, the results suggest that, when offering an adequate number of sessions, both EMDR and CBT have the potential to be effective treatments for patients with low self-esteem and a wide range of comorbid psychiatric conditions. This study was registered at www.trialregister.nl with identifier NTR4611.

  7. The Effect of EMDR and CBT on Low Self-esteem in a General Psychiatric Population: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Brecht T. Griffioen

    2017-11-01

    Full Text Available Although low self-esteem has been found to be an important factor in the development and maintenance of psychopathology, surprisingly little is known about its treatment. This study investigated the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR therapy and Cognitive Behavioural Therapy (CBT, regarding their capacities in enhancing self-esteem in a general psychiatric secondary health care population. A randomized controlled trial with two parallel groups was used. Participants were randomly allocated to either 10 weekly sessions of EMDR (n = 15 or CBT (n = 15. They were assessed pre-treatment, after each session, post treatment and at 3 months follow-up on self-esteem (Rosenberg Self-esteem Scale and Credibility of Core Beliefs, psychological symptoms (Brief Symptom Inventory, social anxiety, and social interaction (Inventory of Interpersonal Situations (IIS. The data were analyzed using repeated measures ANOVA for the complete cases (n = 19 and intention-to-treat (n = 30 to examine differences over time and between conditions. Both groups, EMDR as well as CBT, showed significant improvements on self-esteem, increasing two standard deviations on the main parameter (RSES. Furthermore, the results showed significant reductions in general psychiatric symptoms. The effects were maintained at 3 months follow-up. No between-group differences could be detected. Although the small sample requires to exercise caution in the interpretation of the findings, the results suggest that, when offering an adequate number of sessions, both EMDR and CBT have the potential to be effective treatments for patients with low self-esteem and a wide range of comorbid psychiatric conditions. This study was registered at www.trialregister.nl with identifier NTR4611.

  8. Considerations for preparing a randomized population health intervention trial: lessons from a South African–Canadian partnership to improve the health of health workers

    Directory of Open Access Journals (Sweden)

    Annalee Yassi

    2014-05-01

    Full Text Available Background: Community-based cluster-randomized controlled trials (RCTs are increasingly being conducted to address pressing global health concerns. Preparations for clinical trials are well-described, as are the steps for multi-component health service trials. However, guidance is lacking for addressing the ethical and logistic challenges in (cluster RCTs of population health interventions in low- and middle-income countries. Objective: We aimed to identify the factors that population health researchers must explicitly consider when planning RCTs within North–South partnerships. Design: We reviewed our experiences and identified key ethical and logistic issues encountered during the pre-trial phase of a recently implemented RCT. This trial aimed to improve tuberculosis (TB and Human Immunodeficiency Virus (HIV prevention and care for health workers by enhancing workplace assessment capability, addressing concerns about confidentiality and stigma, and providing onsite counseling, testing, and treatment. An iterative framework was used to synthesize this analysis with lessons taken from other studies. Results: The checklist of critical factors was grouped into eight categories: 1 Building trust and shared ownership; 2 Conducting feasibility studies throughout the process; 3 Building capacity; 4 Creating an appropriate information system; 5 Conducting pilot studies; 6 Securing stakeholder support, with a view to scale-up; 7 Continuously refining methodological rigor; and 8 Explicitly addressing all ethical issues both at the start and continuously as they arise. Conclusion: Researchers should allow for the significant investment of time and resources required for successful implementation of population health RCTs within North–South collaborations, recognize the iterative nature of the process, and be prepared to revise protocols as challenges emerge.

  9. What Happens When Employers are Free to Discriminate? Evidence from the English Barclays Premier Fantasy Football League

    OpenAIRE

    Bryson, Alex; Chevalier, Arnaud

    2014-01-01

    Research on employers' hiring discrimination is limited by the unlawfulness of such activity. Consequently, researchers have focused on the intention to hire. Instead, we rely on a virtual labour market, the Fantasy Football Premier League, where employers can freely exercise their taste for racial discrimination in terms of hiring and firing. The setting allows us to eliminate co-worker, consumer-based and statistical discrimination as potential sources of discrimination, thus isolating the ...

  10. Chinese Dream——Concert in Commemoration of 115th Birth Anniversary of Premier Zhou Enlai Held

    Institute of Scientific and Technical Information of China (English)

    Our; Staff; Reporter

    2013-01-01

    <正>The theme song of the film The Founding of a Republic sung by male vocalists Dai Yuqiang and Wei Song reverberated in the Opera Hall at the National Center for the Performing Arts on the `evening of March 14. It marked the start of the concert in commemoration of the 115th anniversary of the birth of Premier Zhou Enlai, with "Chinese Dream" as the theme.

  11. Pengaruh Kualitas Pelayanan, Harga Dan Lokasi Terhadap Loyalitas Melalui Kepuasan Tamu Pada Santika Premiere Dyandra Hotel & Convention Medan

    OpenAIRE

    Tambunan, Susi Marta

    2016-01-01

    Santika Premiere Dyandra Hotel & Convention, Medan, is one of movers in hotel service industry which combines products and services, including the combination of service quality, price, and location in order to attract and provide satisfaction for its guests. It also pays attention to and gives expectation and needs for the guests by giving something correctly which are in line with the guests’ need by providing good performance so that they will be satisfied and will eventually be loyal to t...

  12. Epidemiology and history of knee injury and its impact on activity limitation among football premier league professional referees.

    Science.gov (United States)

    Mahdavi Mohtasham, Hamid; Shahrbanian, Shahnaz; Khoshroo, Fatemeh

    2018-01-01

    The purpose of this study was to determine the epidemiology and history of knee injury and its impact on activity limitation among football premier league professional referees in Iran. This was a descriptive study. 59 Football Premier League professional referees participated in the study. The knee injury related information such as injury history and mechanism was recorded. Injury related symptoms and their impacts on the activity limitation, ability to perform activities of daily living as well participation in sports and recreational activities was obtained through the Knee Outcome Survey (KOS). The results indicated that 31 out of 59 participants reported the history of knee injury. In addition, 18.6%, 22.4% and 81% of the referees reported that they had been injured during the last 6 months of the last year, and at some point in their refereeing careers, respectively. Results further indicated that 48.8% of the injuries occurred in the non-dominant leg and they occurred more frequently during training sessions (52%). Furthermore, the value of KOS was 85 ± 13 for Activities of Daily Living subscale and 90 ± 9 for Sports and Recreational Activities subscale of the KOS. Knee injury was quite common among the Football Premier League professional referees. It was also indicated that the injuries occurred mainly due to insufficient physical fitness. Therefore, it is suggested that football referees undergo the proper warm-up program to avoid knee injury.

  13. Screening for type 2 diabetes and population mortality over 10 years (ADDITION-Cambridge): a cluster-randomised controlled trial.

    Science.gov (United States)

    Simmons, Rebecca K; Echouffo-Tcheugui, Justin B; Sharp, Stephen J; Sargeant, Lincoln A; Williams, Kate M; Prevost, A Toby; Kinmonth, Ann Louise; Wareham, Nicholas J; Griffin, Simon J

    2012-11-17

    The increasing prevalence of type 2 diabetes poses a major public health challenge. Population-based screening and early treatment for type 2 diabetes could reduce this growing burden. However, uncertainty persists around the benefits of screening for type 2 diabetes. We assessed the effect of a population-based stepwise screening programme on mortality. In a pragmatic parallel group, cluster-randomised trial, 33 general practices in eastern England were randomly assigned by the method of minimisation in an unbalanced design to: screening followed by intensive multifactorial treatment for people diagnosed with diabetes (n=15); screening plus routine care of diabetes according to national guidelines (n=13); and a no-screening control group (n=5). The study population consisted of 20,184 individuals aged 40-69 years (mean 58 years), at high risk of prevalent undiagnosed diabetes, on the basis of a previously validated risk score. In screening practices, individuals were invited to a stepwise programme including random capillary blood glucose and glycated haemoglobin (HbA(1c)) tests, a fasting capillary blood glucose test, and a confirmatory oral glucose tolerance test. The primary outcome was all-cause mortality. All participants were flagged for mortality surveillance by the England and Wales Office of National Statistics. Analysis was by intention-to-screen and compared all-cause mortality rates between screening and control groups. This study is registered, number ISRCTN86769081. Of 16,047 high-risk individuals in screening practices, 15,089 (94%) were invited for screening during 2001-06, 11,737 (73%) attended, and 466 (3%) were diagnosed with diabetes. 4137 control individuals were followed up. During 184,057 person-years of follow up (median duration 9·6 years [IQR 8·9-9·9]), there were 1532 deaths in the screening practices and 377 in control practices (mortality hazard ratio [HR] 1·06, 95% CI 0·90-1·25). We noted no significant reduction in

  14. PENGARUH PEMBAGIAN KERJA TERHADAP PENINGKATAN EFISIENSI KERJA KARYAWAN PASTRY DI HOTEL SANTIKA PREMIERE MALANG

    Directory of Open Access Journals (Sweden)

    Estikowati Estikowati

    2017-12-01

    Full Text Available The study was conducted to determine the effect of the division of labor on the work efficiency of pastry employees at Hotel Santika Premiere Malang. Work efficiency relates to the product produced with the resources used. While the division of labor is a separator type of work done by individuals. Researchers used the Simple Linear Regression Analyze method to predict how far the value of the dependent variable will be changed if the independent variable is changed. From result of research of independent variable (X that is Division of labor and dependent variable (Y Work efficiency have significant relation. This is evidenced from the data processing is known significant value sebersar 0.003 <0.05, with the conclusion Ho rejected and Ha accepted that there is influence between the Division of labor (X on Efficiency of work. From the questionnaire data the authors conclude that the existing division of labor is not appropriate for employees so that the level of efficiency of employees decreased. Normal 0 false false false IN X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-parent:""; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin-top:0cm; mso-para-margin-right:0cm; mso-para-margin-bottom:10.0pt; mso-para-margin-left:0cm; line-height:115%; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:IN;} The study was conducted to determine the effect of the division of labor on the work efficiency of pastry employees at Hotel Santika Premiere Malang. Work efficiency relates to the product produced with the resources used. While the division of labor is

  15. The first metallurgical tests on plutonium; Premiers essais metallurgiques sur le plutonium

    Energy Technology Data Exchange (ETDEWEB)

    Grison, E; Abramson, R; Anselin, F; Monti, H [Commissariat a l' Energie Atomique, Saclay (France). Centre d' Etudes Nucleaires

    1958-07-01

    Metallic plutonium was first prepared in France in January 1956, as soon as we had access to quantities of the order of several grams of plutonium, which had been extracted from the rods of the pile EL2 at Saclay. Since up to the present this reactor, of thermal power 2 000 kW, has been our only source of plutonium, we have so far only worked on experimental quantities sufficient for the basic tests but not for tests on a scale of possible applications. It is this work, carried out during this phase of preliminary research, which is described below. With the starting up of the plutonium extraction plant at Marcoule, where the reactor G1 has been operating at power for more than a year, we shall go on next to a another order of magnitude which will allow the manufacture and experimentation of prototype fuel elements. (author) [French] La premiere elaboration de plutonium metallique en France fut faite en janvier 1956, des que nous pumes disposer de quantites de plutonium de l'ordre de quelques grammes, qui avaient ete retires des barreaux de la pile EL2 de Saclay. Ce reacteur, d'une puissance thermique de 2 000 kW, ayant ete jusqu'a present notre seule source de plutonium, nous n'avons encore travaille que sur des quantites experimentales suffisantes pour les essais de base, mais non pour des essais a l'echelle d'applications possibles. Ce sont les travaux effectues pendant cette phase de recherches preliminaires qui seront evoques ci-dessous. Avec la mise eu route de l'usine d'extraction de plutonium de Marcoule, ou le reacteur G1 fonctionne en puissance depuis plus d'un an, nous allons passer prochainement a un autre ordre de grandeur, qui nous permettra la fabrication et l'experimentation d'elements combustibles prototypes. (auteur)

  16. Corporate social responsibility and mental health: the Premier League football Imagine Your Goals programme.

    Science.gov (United States)

    Henderson, Claire; O'Hara, Stefanie; Thornicroft, Graham; Webber, Martin

    2014-08-01

    Football is increasingly used to facilitate recovery in mental health services, often in partnership with football clubs. However, few clubs have made mental health part of their corporate social responsibility programmes until recently. We report the impact on participants of the 'Imagine Your Goals' programme, run by 16 Premier League football clubs in conjunction with England's Time to Change programme to reduce mental health-related stigma and discrimination. Mixed methods evaluation used pre/post measures of well-being, access to social capital, focus groups held early on and towards the end of the two-year programmes, and questionnaires for coaching staff. There were no significant changes to participants' mental well-being scores between baseline and follow-up, nor to the total number of social resources accessible through their networks. However, there was a statistically significant increase at follow-up in the mean score of the personal skills subscale of the Resource Generator-UK. Participants' individual skills were also higher at follow-up. Qualitative data showed programmes had largely met participants' expectations in terms of socializing, providing structure and improving fitness levels, exceeded expectations in relationships with coaching staff and additional activities, but did not always meet them in improving football skills. Participants varied in their knowledge of exit opportunities, depending on which club's programme they attended. A minority of clubs reported difficulties in recruitment and concerns about planning for the future of the projects. Football clubs and the charitable foundations they set up can successfully deliver programmes to people with mental health problems which improve access to personal skills social capital and have other potential benefits.

  17. Mobil positioning itself to become Canada's premier oil and gas company

    International Nuclear Information System (INIS)

    Thomas, A.

    1994-01-01

    To achieve its goal of becoming Canada's premier oil and gas company by the year 2000, Mobil Oil Canada is empowering its employees and applying appropriate technology to unlock resources and create value. Mobil produces 4.1 million m 3 of oil and natural gas liquids, 5.6 million m 3 /y of natural gas and 438,000 tonnes/y of sulfur. It also operates over 3,000 wells in western Canada and eleven gas processing plants, manages 1,700 km of pipeline, and has 33% interest in the Hibernia project on the Grand Banks. Oil lifting costs have decreased over the past three years from $3.40/bbl to $2.80/bbl and development costs are under $2/bbl. Innovative technology used to achieve high production and low costs include the use of three dimensional seismic surveys and horizontal drilling. Other techniques used at particular sites include installation of downhole injection regulators to control problems of segregation and metering between different water injection zones at the Carson Creek field, use of artificial lifts in gas wells, and a dual gas lift at the Rainbow Lake oil field. At the Lone Pine gas plant, the first Superclaus-99 sulfur recovery process was installed, reducing sulfur emissions by 60% and increasing recovery efficiency from 95% to 98%. Mobil has operated in Canada since 1940 and has made significant discoveries, including Canada's largest producing oil field, the Pembina. In 1971, Mobil discovered gas of commercial significance off the east coast and helped discover the Hibernia and Venture fields. The Hibernia project is scheduled to come on stream in 1997 and Mobil expects the economics of the project to be favorable, with a $12-13/bbl oil price needed to break even. 7 figs

  18. Descriptive epidemiology of injuries in a Brazilian premier league soccer team

    Directory of Open Access Journals (Sweden)

    Fachina RJ

    2013-06-01

    Full Text Available Rafael Júlio de Freitas Guina Fachina,1,2 Marília dos Santos Andrade,3 Fernando Roberto Silva,4 Silas Waszczuk-Junior,4 Paulo César Montagner,1 João Paulo Borin,1 Claudio Andre Barbosa de Lira5 1Departamento de Ciência do Esporte, Faculdade de Educação Física, Universidade Estadual de Campinas (UNICAMP, Campinas, Brazil; 2Confederação Brasileira de Basketball (CBB, Rio de Janeiro, Brazil; 3Departamento de Fisiologia, Universidade Federal de São Paulo, São Paulo, Brazil; 4Grêmio Barueri Futebol LTDA, Barueri, Brazil; 5Setor de Fisiologia Humana e do Exercício, Universidade Federal de Goiás, Câmpus Jataí, Jataí, Brazil Abstract: Soccer, which has a large number of participants, has a high injury incidence that causes both financial and time burdens. Therefore, knowledge about the epidemiology of soccer injuries could allow sports-medicine professionals, such as physicians and physiotherapists, to direct their work in specific preventive programs. Thus, our aim was to conduct an epidemiological survey of injuries sustained by professional soccer players from the same team who participated in the Brazilian championship premier league in 2009. To this end, we evaluated retrospectively player medical records from the team, which included name, date of birth, position, date of injury, mechanism of injury, and type of injury. In the period of study, 95 injuries were recorded: 42 (44.2% were recorded during matches, and 53 (55.8% during the training period. Injuries occurred more frequently in midfielders and strikers. All injuries happened in the lower limb, most of the injuries were muscular, and most occurred as the result of collisions with other athletes. In summary, this study demonstrates that there is a need for greater safety awareness in the training environment. Keywords: injuries, epidemiology, soccer players

  19. "Open mesh" or "strictly selected population" recruitment? The experience of the randomized controlled MeMeMe trial

    Directory of Open Access Journals (Sweden)

    Cortellini M

    2017-07-01

    Full Text Available Mauro Cortellini, Franco Berrino, Patrizia Pasanisi Department of Preventive & Predictive Medicine, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy Abstract: Among randomized controlled trials (RCTs, trials for primary prevention require large samples and long follow-up to obtain a high-quality outcome; therefore the recruitment process and the drop-out rates largely dictate the adequacy of the results. We are conducting a Phase III trial on persons with metabolic syndrome to test the hypothesis that comprehensive lifestyle changes and/or metformin treatment prevents age-related chronic diseases (the MeMeMe trial, EudraCT number: 2012-005427-32, also registered on ClinicalTrials.gov [NCT02960711]. Here, we briefly analyze and discuss the reasons which may lead to participants dropping out from trials. In our experience, participants may back out of a trial for different reasons. Drug-induced side effects are certainly the most compelling reason. But what are the other reasons, relating to the participants’ perception of the progress of the trial which led them to withdraw after randomization? What about the time-dependent drop-out rate in primary prevention trials? The primary outcome of this analysis is the point of drop-out from trial, defined as the time from the randomization date to the withdrawal date. Survival functions were non-parametrically estimated using the product-limit estimator. The curves were statistically compared using the log-rank test (P=0.64, not significant. Researchers involved in primary prevention RCTs seem to have to deal with the paradox of the proverbial “short blanket syndrome”. Recruiting only highly motivated candidates might be useful for the smooth progress of the trial but it may lead to a very low enrollment rate. On the other hand, what about enrolling all the eligible subjects without considering their motivation? This might boost the enrollment rate, but it can lead to biased

  20. "Open mesh" or "strictly selected population" recruitment? The experience of the randomized controlled MeMeMe trial.

    Science.gov (United States)

    Cortellini, Mauro; Berrino, Franco; Pasanisi, Patrizia

    2017-01-01

    Among randomized controlled trials (RCTs), trials for primary prevention require large samples and long follow-up to obtain a high-quality outcome; therefore the recruitment process and the drop-out rates largely dictate the adequacy of the results. We are conducting a Phase III trial on persons with metabolic syndrome to test the hypothesis that comprehensive lifestyle changes and/or metformin treatment prevents age-related chronic diseases (the MeMeMe trial, EudraCT number: 2012-005427-32, also registered on ClinicalTrials.gov [NCT02960711]). Here, we briefly analyze and discuss the reasons which may lead to participants dropping out from trials. In our experience, participants may back out of a trial for different reasons. Drug-induced side effects are certainly the most compelling reason. But what are the other reasons, relating to the participants' perception of the progress of the trial which led them to withdraw after randomization? What about the time-dependent drop-out rate in primary prevention trials? The primary outcome of this analysis is the point of drop-out from trial, defined as the time from the randomization date to the withdrawal date. Survival functions were non-parametrically estimated using the product-limit estimator. The curves were statistically compared using the log-rank test ( P =0.64, not significant). Researchers involved in primary prevention RCTs seem to have to deal with the paradox of the proverbial "short blanket syndrome". Recruiting only highly motivated candidates might be useful for the smooth progress of the trial but it may lead to a very low enrollment rate. On the other hand, what about enrolling all the eligible subjects without considering their motivation? This might boost the enrollment rate, but it can lead to biased results on account of large proportions of drop-outs. Our experience suggests that participants do not change their mind depending on the allocation group (intervention or control). There is no single

  1. Determining clinical benefits of drug-eluting coronary stents according to the population risk profile: a meta-regression from 31 randomized trials.

    Science.gov (United States)

    Moreno, Raul; Martin-Reyes, Roberto; Jimenez-Valero, Santiago; Sanchez-Recalde, Angel; Galeote, Guillermo; Calvo, Luis; Plaza, Ignacio; Lopez-Sendon, Jose-Luis

    2011-04-01

    The use of drug-eluting stents (DES) in unfavourable patients has been associated with higher rates of clinical complications and stent thrombosis, and because of that concerns about the use of DES in high-risk settings have been raised. This study sought to demonstrate that the clinical benefit of DES increases as the risk profile of the patients increases. A meta-regression analysis from 31 randomized trials that compared DES and bare-metal stents, including overall 12,035 patients, was performed. The relationship between the clinical benefit of using DES (number of patients to treat [NNT] to prevent one episode of target lesion revascularization [TLR]), and the risk profile of the population (rate of TLR in patients allocated to bare-metal stents) in each trial was evaluated. The clinical benefit of DES increased as the risk profile of each study population increased: NNT for TLR=31.1-1.2 (TLR for bare-metal stents); prisk profile of each study population, since the effect of DES in mortality, myocardial infarction, and stent thrombosis, was not adversely affected by the risk profile of each study population (95% confidence interval for β value 0.09 to 0.11, -0.12 to 0.19, and -0.03 to-0.15 for mortality, myocardial infarction, and stent thrombosis, respectively). The clinical benefit of DES increases as the risk profile of the patients increases, without affecting safety. Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.

  2. Early intervention of multiple home visits to prevent childhood obesity in a disadvantaged population: a home-based randomised controlled trial (Healthy Beginnings Trial

    Directory of Open Access Journals (Sweden)

    Alperstein Garth

    2007-05-01

    Full Text Available Abstract Background Studies have shown that a proportion of children as young as two years are already overweight. This indicates that obesity prevention programs that commence as early as possible and are family-focused are needed. This Healthy Beginnings Trial aims to determine the efficacy of a community-based randomized controlled trial (RCT of a home visiting intervention in preventing the early onset of childhood overweight and obesity. The intervention will be conducted over the first two years of life to increase healthy feeding behaviours and physical activity, decrease physical inactivity, enhance parent-child interaction, and hence reduce overweight and obesity among children at 2 and 5 years of age in the most socially and economically disadvantaged areas of Sydney, Australia. Methods/design This RCT will be conducted with a consecutive sample of 782 first time mothers with their newborn children. Pregnant women who are expecting their first child, and who are between weeks 24 and 34 of their pregnancy, will be invited to participate in the trial at the antenatal clinic. Informed consent will be obtained and participants will then be randomly allocated to the intervention or the control group. The allocation will be concealed by sequentially numbered, sealed opaque envelopes containing a computer generated random number. The intervention comprises eight home visits from a specially trained community nurse over two years and pro-active telephone support between the visits. Main outcomes include a duration of breastfeeding measured at 6 and 12 months, b introduction of solids measured at 4 and 6 months, c nutrition, physical activity and television viewing measured at 24 months, and d overweight/obesity status at age 2 and 5 years. Discussion The results of this trial will ascertain whether the home based early intervention is effective in preventing the early onset of childhood overweight and obesity. If proved to be effective, it

  3. A novel complete-case analysis to determine statistical significance between treatments in an intention-to-treat population of randomized clinical trials involving missing data.

    Science.gov (United States)

    Liu, Wei; Ding, Jinhui

    2018-04-01

    The application of the principle of the intention-to-treat (ITT) to the analysis of clinical trials is challenged in the presence of missing outcome data. The consequences of stopping an assigned treatment in a withdrawn subject are unknown. It is difficult to make a single assumption about missing mechanisms for all clinical trials because there are complicated reactions in the human body to drugs due to the presence of complex biological networks, leading to data missing randomly or non-randomly. Currently there is no statistical method that can tell whether a difference between two treatments in the ITT population of a randomized clinical trial with missing data is significant at a pre-specified level. Making no assumptions about the missing mechanisms, we propose a generalized complete-case (GCC) analysis based on the data of completers. An evaluation of the impact of missing data on the ITT analysis reveals that a statistically significant GCC result implies a significant treatment effect in the ITT population at a pre-specified significance level unless, relative to the comparator, the test drug is poisonous to the non-completers as documented in their medical records. Applications of the GCC analysis are illustrated using literature data, and its properties and limits are discussed.

  4. Effectiveness of the population-based Check your health preventive programme conducted in primary care with 4 years follow-up [the CORE trial]: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Maindal, Helle Terkildsen; Støvring, Henrik; Sandbaek, Annelli

    2014-08-29

    The periodic health check-up has been a fundamental part of routine medical practice for decades, despite a lack of consensus regarding its value in health promotion and disease prevention. A large-scale Danish population-based preventive programme 'Check your health' was developed based on available evidence of screening and successive accepted treatment, prevention for diseases and health promotion, and is closely aligned with the current health care system.The objective of the 'Check your health' [CORE] trial is to investigate effectiveness on health outcomes of a preventive health check offered at a population-level to all individuals aged 30-49 years, and to establish the cost-effectiveness. The trial will be conducted as a pragmatic household-cluster randomised controlled trial involving 10,505 individuals. All individuals within a well-defined geographical area in the Central Denmark Region, Denmark (DK) were randomised to be offered a preventive health check (Intervention group, n = 5250) or to maintain routine access to healthcare until a delayed intervention (Comparison group, n = 5255). The programme consists of a health examination which yields an individual risk profile, and according to this participants are assigned to one of the following interventions: (a) referral to a health promoting consultation in general practice, (b) behavioural programmes at the local Health Centre, or (c) no need for follow-up.The primary outcomes at 4 years follow-up are: ten-year-risk of fatal cardiovascular event (Heart-SCORE model), physical activity level (self-report and cardiorespiratory fitness), quality of life (SF12), sick leave and labour market attachment. Cost-effectiveness will be evaluated according to life years gained, direct costs and total health costs. Intention to treat analysis will be performed. Results from the largest Danish health check programme conducted within the current healthcare system, spanning the sectors which share responsibility for

  5. Etat des lieux des soins de premier recours des malades mentaux à Antananarivo : étude rétrospective

    Science.gov (United States)

    Bakohariliva, Hasina Andrianarivony; Rafehivola, Imisanavalona Hanitrinihaja; Raobelle, Evah Norotiana; Raharivelo, Adeline; Rajaonarison, Bertille Hortense

    2018-01-01

    Résumé Religion et guérisseurs traditionnels occupent encore une place prépondérante dans la prise en charge des maladies mentales à Madagascar. Ainsi, nous nous sommes fixés comme objectif d'établir un état des lieux sur les soins de premier recours des malades mentaux. Nous avons mené une étude rétrospective descriptive s'étalant sur une période de 16 mois allant de janvier 2014 en avril 2015 au sein du service de psychiatrie du CHU de Befelatanana à Antananarivo. La prévalence des psychoses était de 25%. Le genre féminin (53%), l'ethnie merina (77%), les étudiants (45%), le niveau d'étude secondaire (40%), les célibataires (72%), la religion protestante (45%), ainsi que le niveau socio-économique moyen (57,5%) étaient prédominants. Dans les paramètres cliniques, le mode de début brutal (52%), le premier recours à la religion (40%), la présence d'antécédents des cas similaire (90%), étaient majoritaires. La schizophrénie était la pathologie la plus rencontrée dans la moitié des cas. Le délai d'amélioration en cas de traitement religieux et traditionnels était dans la moitié des cas de plus de 10 jours d'hospitalisation. Les patients ayant reçu une prise en charge psychiatrique en premier recours, étaient améliorés dans 75 % cas en moins de 10jours. Le retard du recours aux soins psychiatriques est une réalité à Madagascar qui aggrave le pronostic des psychoses. PMID:29632623

  6. Group based prenatal care in a low-and high risk population in the Netherlands: a study protocol for a stepped wedge cluster randomized controlled trial.

    Science.gov (United States)

    van Zwicht, Birgit S; Crone, Matty R; van Lith, Jan M M; Rijnders, Marlies E B

    2016-11-15

    CenteringPregnancy (CP) is a multifaceted group based care-model integrated in routine prenatal care, combining health assessment, education, and support. CP has shown some positive results on perinatal outcomes. However, the effects are less obvious when limited to the results of randomized controlled trials: as there are few trials and there is a variation in reported outcomes. Furthermore, former research was mostly conducted in the United States of America and in specific (often high risk) populations. Our study aims to evaluate the effects of CP in the Netherlands in a general population of pregnant women (low and high risk). Furthermore we aim to explore the mechanisms leading to the eventual effects by measuring potential mediating factors. We will perform a stepped wedge cluster randomized controlled trial, in a Western region in the Netherlands. Inclusion criteria are care, women in the intervention period (starting at the randomized time-point) will be offered the choice between individual care or CP. Primary outcomes are maternal and neonatal morbidity, retrieved from a national routine database. Secondary outcomes are health behavior, psychosocial outcomes, satisfaction, health care utilization and process outcomes, collected through self-administered questionnaires, group-evaluations and individual interviews. We will conduct intention-to-treat analyses. Also a per protocol analysis will be performed comparing the three subgroups: control group, CP-participants and non-CP-participants, using multilevel techniques to account for clustering effects. This study contributes to the evidence regarding the effect of CP and gives a first indication of the effect and implementation of CP in both low and high-risk pregnancies in a high-income Western society other than the USA. Also, measuring factors that are hypothesized to mediate the effect of CP will enable to explain the mechanisms that lead to effects on maternal and neonatal outcomes. Dutch Trial

  7. Intensive versus conventional blood pressure monitoring in a general practice population. The Blood Pressure Reduction in Danish General Practice trial: a randomized controlled parallel group trial.

    Science.gov (United States)

    Klarskov, Pia; Bang, Lia E; Schultz-Larsen, Peter; Gregers Petersen, Hans; Benee Olsen, David; Berg, Ronan M G; Abrahamsen, Henrik; Wiinberg, Niels

    2018-01-17

    To compare the effect of a conventional to an intensive blood pressure monitoring regimen on blood pressure in hypertensive patients in the general practice setting. Randomized controlled parallel group trial with 12-month follow-up. One hundred and ten general practices in all regions of Denmark. One thousand forty-eight patients with essential hypertension. Conventional blood pressure monitoring ('usual group') continued usual ad hoc blood pressure monitoring by office blood pressure measurements, while intensive blood pressure monitoring ('intensive group') supplemented this with frequent home blood pressure monitoring and 24-hour ambulatory blood pressure monitoring. Mean day- and night-time systolic and diastolic 24-hour ambulatory blood pressure. Change in systolic and diastolic office blood pressure and change in cardiovascular risk profile. Of the patients, 515 (49%) were allocated to the usual group, and 533 (51%) to the intensive group. The reductions in day- and night-time 24-hour ambulatory blood pressure were similar (usual group: 4.6 ± 13.5/2.8 ± 82 mmHg; intensive group: 5.6 ± 13.0/3.5 ± 8.2 mmHg; P = 0.27/P = 0.20). Cardiovascular risk scores were reduced in both groups at follow-up, but more so in the intensive than in the usual group (P = 0.02). An intensive blood pressure monitoring strategy led to a similar blood pressure reduction to conventional monitoring. However, the intensive strategy appeared to improve patients' cardiovascular risk profile through other effects than a reduction of blood pressure. Clinical Trials NCT00244660. © The Author 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  8. Shirt sponsorship by gambling companies in the English and Scottish Premier Leagues: global reach and public health concerns

    OpenAIRE

    Bunn, C.; Ireland, R.; Minton, J.; Holman, D.J.; Philpott, M.; Chambers, S.

    2018-01-01

    While the nature of gambling practices is contested, a strong evidence\\ud base demonstrates that gambling can become a serious disorder and have\\ud a range of detrimental effects for individuals, communities and societies.\\ud Over the last decade, football in the UK has become visibly entwined with\\ud gambling marketing. To explore this apparent trend, we tracked shirt\\ud sponsors in both the English and Scottish Premier Leagues since 1992 and\\ud found a pronounced increase in the presence of...

  9. Screening for type 2 diabetes in a high-risk population: Study design and feasibility of a population-based randomized controlled trial

    NARCIS (Netherlands)

    B. Klijs (Bart); S.J. Otto (Suzie); R.J. Heine (Robert); Y. van der Graaf (Yolanda); J.J. Lous (Jan); H.J. de Koning (Harry)

    2012-01-01

    textabstractBackground: We describe the design and present the results of the first year of a population-based study of screening for type 2 diabetes in individuals at high risk of developing the disease. High risk is defined as having abdominal obesity. Methods. Between 2006 and 2007, 79,142

  10. Screening for type 2 diabetes in a high-risk population: study design and feasibility of a population-based randomized controlled trial

    NARCIS (Netherlands)

    Klijs, B.; Otto, S.J.; Heine, R.J.; van der Graaf, Y.; Lous, J.J.; Koning, H.J.

    2012-01-01

    Background: We describe the design and present the results of the first year of a population-based study of screening for type 2 diabetes in individuals at high risk of developing the disease. High risk is defined as having abdominal obesity. Methods. Between 2006 and 2007, 79,142 inhabitants of two

  11. Associations among comorbid anxiety, psychiatric symptomatology, and diabetic control in a population with serious mental illness and diabetes: Findings from an interventional randomized controlled trial.

    Science.gov (United States)

    Aftab, Awais; Bhat, Chetan; Gunzler, Douglas; Cassidy, Kristin; Thomas, Charles; McCormick, Richard; Dawson, Neal V; Sajatovic, Martha

    2018-05-01

    Objective Serious mental illness and type II diabetes mellitus have a high comorbidity, and both have a higher prevalence of anxiety disorders compared to the general population. Targeted Training in Illness Management is a group-based self-management training approach which targets serious mental illness and type II diabetes mellitus concurrently. This analysis examines data from a randomized controlled trial of Targeted Training in Illness Management intervention to examine the impact of comorbid anxiety on baseline psychiatric symptomatology and diabetic control, and on longitudinal treatment outcomes. Methods We conducted secondary analyses on data from a prospective, 60-week, randomized controlled trial testing Targeted Training in Illness Management versus treatment as usual in 200 individuals with serious mental illness and diabetes. Primary outcomes included measures related to serious mental illness symptoms, functional status, general health status, and diabetes control. Measures were compared between those participants with anxiety disorders versus those without anxiety at baseline as well as over time using linear mixed effects analyses. Results Forty seven percent of the participants had one or more anxiety disorders. At baseline, those with an anxiety diagnosis had higher illness severity, depressive, and other psychiatric symptomatology and disability. Diabetic control (HbA1c) was not significantly different at baseline. In the longitudinal analyses, no significant mean slope differences over time (group-by-time interaction effect) between those with anxiety diagnoses and those without in treatment as usual group were found for primary outcomes. Within the Targeted Training in Illness Management arm, those with anxiety disorders had significantly greater improvement in mental health functioning. Those with anxiety comorbidity in the Targeted Training in Illness Management group demonstrated significantly lower HbA1c levels compared to no anxiety

  12. 'Pragmatic randomized controlled trial of individually prescribed exercise versus usual care in a heterogeneous cancer survivor population': a feasibility study PEACH trial: prescribed exercise after chemotherapy.

    LENUS (Irish Health Repository)

    Walsh, Julie M

    2010-01-01

    BACKGROUND: Many cancer survivors suffer a range of physical and psychological symptoms which may persist for months or years after cessation of treatment. Despite the known benefits of exercise and its potential to address many of the adverse effects of treatment, the role of exercise as well as optimum duration, frequency, and intensity in this population has yet to be fully elucidated. Many cancer rehabilitation programmes presented in the literature are very long and have tight eligibility criteria which make them non-applicable to the majority of cancer survivors. This paper presents the protocol of a novel 8-week intervention which aims to increase fitness, and address other physical symptoms in a heterogeneous cancer survivor population. METHODS\\/DESIGN: The aim is to recruit 64 cancer survivors 2-6 months after completion of chemotherapy, usually adjuvant, with curative intent. Subjects will be recruited through oncology clinics in a single institution and randomised to usual care or an exercise intervention. The exercise intervention consists of two specifically tailored supervised moderate intensity aerobic exercise sessions weekly over 8-weeks. All participants will be assessed at baseline (0 weeks), at the end of the intervention (8 weeks), and at 3-month follow-up. The primary outcome measure is fitness, and secondary patient-related outcome measures include fatigue, quality of life, and morphological outcomes. A further secondary outcome is process evaluation including adherence to and compliance with the exercise program. DISCUSSION: This study will provide valuable information about the physical outcomes of this 8-week supervised aerobic programme. Additionally, process information and economic evaluation will inform the feasibility of implementing this program in a heterogeneous population post cessation of chemotherapy.

  13. Premier League academy soccer players' experiences of competing in a tournament bio-banded for biological maturation.

    Science.gov (United States)

    Cumming, Sean P; Brown, Daniel J; Mitchell, Siobhan; Bunce, James; Hunt, Dan; Hedges, Chris; Crane, Gregory; Gross, Aleks; Scott, Sam; Franklin, Ed; Breakspear, Dave; Dennison, Luke; White, Paul; Cain, Andrew; Eisenmann, Joey C; Malina, Robert M

    2018-04-01

    Individual differences in the growth and maturation have been shown to impact player performance and development in youth soccer. This study investigated Premier League academy players' experiences of participating in a tournament bio-banded for biological maturation. Players (N = 66) from four professional soccer clubs aged 11 and 14 years and between 85-90% of adult stature participated in a tournament. Players competed in three 11 vs 11 games on a full size pitch with 25-min halves. Sixteen players participated in four 15-min focus groups and were asked to describe their experiences of participating in the bio-banded tournament in comparison to age group competition. All players described their experience as positive and recommended the Premier League integrate bio-banding into the existing games programme. In comparison to age-group competitions, early maturing players described the bio-banded games more physically challenging, and found that they had to adapt their style of play placing a greater emphasis on technique and tactics. Late maturing players considered the games to be less physically challenging, yet appreciated the having more opportunity to use, develop and demonstrate their technical, physical, and psychological competencies. Bio-banding strategies appear to contribute positively towards the holistic development of young soccer players.

  14. First experiments results about the engineering model of Rapsodie; Premiers resultats d'essais interessant le bloc pile de rapsodie

    Energy Technology Data Exchange (ETDEWEB)

    Chalot, A; Ginier, R; Sauvage, M [Association Euratom-CEA Cadarache (France). Centre d' Etudes Nucleaires

    1964-07-01

    This report deals with the first series of experiments carried out on the engineering model of Rapsodie and on an associated sodium facility set in a laboratory hall of Cadarache. It conveys more precisely: 1/ - The difficulties encountered during the erection and assembly of the engineering model and a compilation of the results of the first series of experiments and tests carried out on this installation (loading of the subassemblies preheating, thermal chocks...). 2/ - The experiments and tests carried out on the two prototypes control rod drive mechanisms which brought to the choice for the design of the definitive drive mechanism. As a whole, the results proved the validity of the general design principles adopted for Rapsodie. (authors) [French] Ce rapport traite des premiers essais realises sur la maquette du bloc pile de Rapsodie et sur une installation annexe de sodium, implantees dans un hall d'essais de Cadarache. Il fait part: 1/- Des difficultes eprouvees lors du montage de la maquette et rassemble les resultats des premiers essais effectues sur cette installation (chargement des assemblages, prechauffage, chocs thermiques...). 2/- Des essais realises sur deux prototypes de mecanisme de barre de controle qui ont conduit a la conception du mecanisme definitif. L'ensemble des resultats obtenus a permis de confirmer la validite des principes adoptes pour la pile Rapsodie. (auteurs)

  15. A cluster randomized controlled trial of a clinical pathway for hospital treatment of heart failure: study design and population

    Directory of Open Access Journals (Sweden)

    Gardini Andrea

    2007-11-01

    Full Text Available Abstract Background The hospital treatment of heart failure frequently does not follow published guidelines, potentially contributing to the high morbidity, mortality and economic cost of this disorder. Consequently the development of clinical pathways has the potential to reduce the current variability in care, enhance guideline adherence, and improve outcomes for patients. Despite enthusiasm and diffusion, the widespread acceptance of clinical pathways remain questionable because very little prospective controlled data demonstrated their effectiveness. The Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways was designed in order to conduct a rigorous evaluation of clinical pathways in hospital treatment of acute heart failure. The primary objective of the trial was to evaluate the effectiveness of the implementation of clinical pathways for hospital treatment of heart failure in Italian hospitals. Methods/design Two-arm, cluster-randomized trial. 14 community hospitals were randomized either to arm 1 (clinical pathway: appropriate use of practice guidelines and supplies of drugs and ancillary services, new organization and procedures, patient education, etc. or to arm 2 (no intervention, usual care. 424 patients sample (212 in each group, 80% of power at the 5% significance level (two-sided. The primary outcome measure is in-hospital mortality. We will also analyze the impact of the clinical pathways comparing the length and the appropriateness of the stay, the rate of unscheduled readmissions, the customers' satisfaction and the costs treating the patients with the pathways and with the current practice along all the observation period. The quality of the care will be assessed by monitoring the use of diagnostic and therapeutic procedures during hospital stay and by measuring key quality indicators at discharge. Discussion This paper examines the design of the evaluation of a complex

  16. The Healthy Toddlers Trial Protocol: An Intervention to Reduce Risk Factors for Childhood Obesity in Economically and Educationally Disadvantaged Populations

    Directory of Open Access Journals (Sweden)

    Auld Garry

    2011-07-01

    Full Text Available Abstract Background The number of overweight children in America has doubled to an estimated 10 million in the past 20 years. Establishing healthy dietary behaviors must begin early in childhood and include parents. The Healthy Toddlers intervention focuses on promoting healthy eating habits in 1- to 3-year-old children utilizing the Social Cognitive Theory and a learner-centered approach using Adult Learning principles. This Healthy Toddlers Trial aims to determine the efficacy of a community-based randomized controlled trial of an in-home intervention with economically and educationally disadvantaged mothers of toddlers. The intervention focuses on: (a promoting healthy eating behaviors in toddlers while dietary habits are forming; and (b providing initial evidence for the potential of Healthy Toddlers as a feasible intervention within existing community-based programs. Methods/Design This describes the study protocol for a randomized control trial, a multi-state project in Colorado, Michigan, and Wisconsin with economically and educationally disadvantaged mother-toddler dyads; toddlers are between 12 and 36 months. The Healthy Toddlers intervention consists of eight in-home lessons and four reinforcement telephone contacts, focusing on fruit, vegetable, and sweetened beverage consumption and parental behaviors, taught by paraprofessional instructors. Healthy Toddlers uses a randomized, experimental, short-term longitudinal design with intervention and control groups. In-home data collection (anthropometric measurements, feeding observations, questionnaires, 3-day dietary records occurs at baseline, immediately following the intervention, and 6 months after the intervention. Main toddler outcomes include: a increased fruit and vegetable consumption and decreased sweetened beverage consumption; and b improved toddler-eating skills (self-feeding and self-serving. Main parent outcomes include: a improved psychosocial attributes (knowledge

  17. The beta-carotene and retinol efficacy trial (CARET) for chemoprevention of lung cancer in high risk populations: smokers and asbestos-exposed workers.

    Science.gov (United States)

    Omenn, G S; Goodman, G; Thornquist, M; Grizzle, J; Rosenstock, L; Barnhart, S; Balmes, J; Cherniack, M G; Cullen, M R; Glass, A

    1994-04-01

    CARET is a multicenter, two-armed, double-masked randomized chemoprevention trial in Seattle, Portland, San Francisco, Baltimore, Connecticut, and Irvine, to test whether oral administration of beta-carotene (30 mg/day) plus retinyl palmitate (25,000 IU/day) can decrease the incidence of lung cancer in high risk populations, namely, heavy smokers and asbestos-exposed workers. The intervention combines the antioxidant action of beta-carotene and the tumor suppressor mechanism of vitamin A. As of April 30, 1993, CARET had randomized 1,845 participants in the 1985-1988 pilot phase plus 13,260 "efficacy" participants since 1989; of these, 4,000 are asbestos-exposed males and 11,105 are smokers and former smokers (44% female). Accrual is complete everywhere except Irvine, which was the last center added (1991), and the safety profile of the regimen to date has been excellent. With 14,420 smokers, 4,010 asbestos-exposed participants, and 114,100 person-years through February 1998, we expect CARET to be capable of detecting a 23% reduction in lung cancer incidence in the two populations combined and 27, 49, 32, and 35% reductions in the smokers, female smokers, male smokers, and asbestos-exposed subgroups, respectively. CARET is highly complementary to the alpha-tocopherol-beta-carotene study in Finland and the Harvard Physicians Health Study (beta-carotene alone) in the National Cancer Institute portfolio of major cancer chemoprevention trials.

  18. Effect of low-dose spironolactone on resistant hypertension in type 2 diabetes mellitus: a randomized controlled trial in a sub-Saharan African population.

    Science.gov (United States)

    Djoumessi, Romance Nguetse; Noubiap, Jean Jacques N; Kaze, Francois Folefack; Essouma, Mickael; Menanga, Alain Patrick; Kengne, Andre Pascal; Mbanya, Jean Claude; Sobngwi, Eugene

    2016-03-23

    Low-dose spironolactone has been proven to be effective for resistant hypertension in the general population, but this has yet to be confirmed in type 2 diabetic (T2DM) patients. We assessed the efficacy of a low-dose spironolactone on resistant hypertension in a sub-Saharan African population of T2DM patients from Cameroon. This was a four-week single blinded randomized controlled trial in 17 subjects presenting with resistant hypertension in specialized diabetes care units in Cameroon. They were randomly assigned to treatment with a daily 25 mg of spironolactone (n = 9) or to an alternative antihypertensive regimen (n = 8), on top of any ongoing regimen and prevailing lifestyle prescriptions. They were seen at the start of the treatment, then 2 and 4 weeks later. The primary outcome was change in office and self-measured blood pressure (BP) during follow-up, and secondary outcomes were changes in serum potassium, sodium, and creatinine levels. Compared with alternative treatment, low-dose spironolactone was associated with significant decrease in office systolic BP (-33 vs. -14 mmHg; p = 0.024), and in diastolic BP (-14 vs. -5 mmHg; p = 0.006). After 1 month of spironolactone, all the patients were controlled based on BP below 130/80 mmHg, with significant office BP reduction from 158 ± 17/86 ± 11 to 125 ± 11/72 ± 8, vs. 158 ± 8/94 ± 8 to 144 ± 17/89 ± 12 mmHg in the alternative treatment group. There was no significant variation in sodium and creatinine levels in both groups, but a mild increase of potassium levels in the spironolactone group. Add-on low-dose spironolactone was effective in reducing BP to optimal levels in T2DM Cameroonian patients despite mild increase in serum potassium. Trial registration ClinicalTrials.gov Identifier NCT02426099. Date of registration April 2015.

  19. The Beneficial Effects of Cognitive Training With Simple Calculation and Reading Aloud (SCRA) in the Elderly Postoperative Population: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Kulason, Kay; Nouchi, Rui; Hoshikawa, Yasushi; Noda, Masafumi; Okada, Yoshinori; Kawashima, Ryuta

    2018-01-01

    Background: There has been little research conducted regarding cognitive treatments for the elderly postsurgical population. Patients aged ≥60 years have an increased risk of postoperative cognitive decline, a condition in which cognitive functions are negatively affected. This cognitive decline can lead to a decline in quality of life. In order to maintain a high quality of life, the elderly postsurgical population may benefit from treatment to maintain and/or improve their cognitive functions. This pilot study investigates the effect of simple calculation and reading aloud (SCRA) cognitive training in elderly Japanese postsurgical patients. Methods: Elderly patients undergoing non-cardiovascular thoracic surgery under general anesthesia were recruited ( n = 12). Subjects were randomly divided into two groups-one that receives 12 weeks of SCRA intervention, and a waitlisted control group. Before and after the intervention, we measured cognitive function [Mini-Mental Status Exam-Japanese (MMSE-J), Frontal Assessment Battery (FAB), computerized Cogstate Brief Battery (CBB)] and emotional state [General Health Questionnaire-12 (GHQ-12), Geriatric Depression Scale (GDS), Quality of Life Scale-5 (QOL-5)]. Results: Group difference analyses using ANCOVA with permutation test showed that the intervention SCRA group had a significant improvement in FAB motor programming sub-score, GDS, and QOL-5 compared to the control group. Within-group analyses using Wilcoxon signed-rank test to compare baseline and follow-up showed that the SCRA intervention group total FAB scores, FAB motor programming sub-scores, and QOL-5 scores were significantly improved. Discussion: This pilot study showed that there are important implications for the beneficial effects of SCRA intervention on cognitive function and emotional state in the postoperative elderly population; however, further investigations are necessary to reach any conclusions. Trial registration: This study was registered with

  20. The Beneficial Effects of Cognitive Training With Simple Calculation and Reading Aloud (SCRA in the Elderly Postoperative Population: A Pilot Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Kay Kulason

    2018-03-01

    Full Text Available Background: There has been little research conducted regarding cognitive treatments for the elderly postsurgical population. Patients aged ≥60 years have an increased risk of postoperative cognitive decline, a condition in which cognitive functions are negatively affected. This cognitive decline can lead to a decline in quality of life. In order to maintain a high quality of life, the elderly postsurgical population may benefit from treatment to maintain and/or improve their cognitive functions. This pilot study investigates the effect of simple calculation and reading aloud (SCRA cognitive training in elderly Japanese postsurgical patients.Methods: Elderly patients undergoing non-cardiovascular thoracic surgery under general anesthesia were recruited (n = 12. Subjects were randomly divided into two groups—one that receives 12 weeks of SCRA intervention, and a waitlisted control group. Before and after the intervention, we measured cognitive function [Mini-Mental Status Exam-Japanese (MMSE-J, Frontal Assessment Battery (FAB, computerized Cogstate Brief Battery (CBB] and emotional state [General Health Questionnaire-12 (GHQ-12, Geriatric Depression Scale (GDS, Quality of Life Scale-5 (QOL-5].Results: Group difference analyses using ANCOVA with permutation test showed that the intervention SCRA group had a significant improvement in FAB motor programming sub-score, GDS, and QOL-5 compared to the control group. Within-group analyses using Wilcoxon signed-rank test to compare baseline and follow-up showed that the SCRA intervention group total FAB scores, FAB motor programming sub-scores, and QOL-5 scores were significantly improved.Discussion: This pilot study showed that there are important implications for the beneficial effects of SCRA intervention on cognitive function and emotional state in the postoperative elderly population; however, further investigations are necessary to reach any conclusions.Trial registration: This study was

  1. [Pierre Chirac "premier physician" of the king and the aborted plan to create an "Académie de médecine" in Paris (1731-1732)].

    Science.gov (United States)

    Lunel, Alexandre

    2005-03-01

    After being appointed "premier physician" in 1731, Pierre Chirac, thanks to his influence with the king, tried to realize an ambitious project. Inspired by the creation of an Academie de Chirurgie by the "premier surgeon", Chirac decided to creation an Académie de Médecine in Paris. Under his guidance, it was planned to collect opinions from all doctors of the kingdom in order to enhance global knowledge of disease, symptoms and treatments. However, threatened with the loss of its secular superiority, the Paris University Medical School immediately opposed the project. Although well advanced, the project was finally abandoned on Chirac's death.

  2. Short- and long-term risks of cardiovascular disease following radiotherapy in rectal cancer in four randomized controlled trials and a population-based register.

    Science.gov (United States)

    Chen, Lingjing; Eloranta, Sandra; Martling, Anna; Glimelius, Ingrid; Neovius, Martin; Glimelius, Bengt; Smedby, Karin E

    2018-03-01

    A population-based cohort and four randomized trials enriched with long-term register data were used to clarify if radiotherapy in combination with rectal cancer surgery is associated with increased risks of cardiovascular disease (CVD). We identified 14,901 rectal cancer patients diagnosed 1995-2009 in Swedish nationwide registers, of whom 9227 were treated with preoperative radiotherapy. Also, we investigated 2675 patients with rectal cancer previously randomized to preoperative radiotherapy or not followed by surgery in trials conducted 1980-1999. Risks of CVD overall and subtypes were estimated based on prospectively recorded hospital visits during relapse-free follow-up using multivariable Cox regression. Maximum follow-up was 18 and 33 years in the register and trials, respectively. We found no association between preoperative radiotherapy and overall CVD risk in the register (Incidence Rate Ratio, IRR = 0.99, 95% confidence interval (CI) 0.92-1.06) or in the pooled trials (IRR = 1.07, 95% CI 0.93-1.24). We noted an increased risk of venous thromboembolism among irradiated patients in both cohorts (IRR register  = 1.41, 95% CI 1.15-2.72; IRR trials  = 1.41, 95% CI 0.97-2.04), that remained during the first 6 months following surgery among patients treated 2006-2009, after the introduction of antithrombotic treatment (IRR 6 months  = 2.30, 95% CI 1.01-5.21). However, the absolute rate difference of venous thromboembolism attributed to RT was low (10 cases per 1000 patients and year). Preoperative radiotherapy did not affect rectal cancer patients' risk of CVD overall. Although an excess risk of short-term venous thromboembolism was noted, the small increase in absolute numbers does not call for general changes in routine prophylactic treatment, but might do so for patients already at high risk of venous thromboembolism. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Happy@Work: protocol for a web-based randomized controlled trial to improve mental well-being among an Asian working population.

    Science.gov (United States)

    Yuan, Qi; Liu, Su; Tang, Szehang; Zhang, Dexing

    2014-07-04

    Mental health issues pose a serious concern in the workplace for the huge productivity loss and financial burden associated with it. Unlike the traditional 'fixing-what-is-wrong' approach, positive psychology offers a less-stigmatized way to promote mental health. Psychological capital, a concept originated from positive psychology, has been proven effective in improving mental well-being and work performance. However, little evidence exists for its implementation among Asian working population or its cost-benefit for organizations adopting such promotion strategy. The current study is designed to assess the protective effects of a web-based psychology capital intervention among Hong Kong working population on individuals' mental health and work performance, as well as organizations' return-on-investment. A two-arm randomized controlled trial design will be adopted. Eligible working adults will be randomly allocated to either the intervention group or the waiting-list control group, with 177 participants in each arm. The intervention, which consists of four web-based training sessions, each targeting one of the psychological capital components (hope, efficacy, optimism and resilience), will be implemented over a 4-week period. On-line surveys will assess the participants in each group at baseline, intervention completion, 1 and 3 months after the completion. The primary outcome is individuals' psychological capital level; secondary outcomes include individuals' well-being, depressive symptoms, work engagement and productivity. Return-on-investment will be calculated from the employers' perspective based on productivity gain, savings in medical expenditure, as well as operation and time costs. Analysis will follow the intention-to-treat principle. This is the first experimental study that explores the applicability of psychological capital development among Asian population. Through investigating changes in individuals' work productivity from absenteeism and

  4. MULTICRITERIA ANALYSIS OF FOOTBALL MATCH PERFORMANCES: COMPOSITION OF PROBABILISTIC PREFERENCES APPLIED TO THE ENGLISH PREMIER LEAGUE 2015/2016

    Directory of Open Access Journals (Sweden)

    Vitor Principe

    Full Text Available ABSTRACT This article aims to analyze the technical performance of football teams in the FA Premier League during the 2015/2016 season. Data of twenty clubs over 38 matches for each club are considered using 23 variables. These variables have been explored in the football literature and address different features of technical performance. The different configuration of the data for teams in detached segments motivated the multi-criteria approach, which enables identification of strong and weak sectors in each segment. The uncertainty as to the outcome of football matches and the imprecision of the measures indicated the use of Composition of Probabilistic Preferences (CPP to model the problem. “R” software was used in the modeling and computation. The CPP global scores obtained were more consistent with the final classification than those of other methods. CPP scores revealed different performances of particular groups of variables indicating aspects to be improved and explored.

  5. Energy Intake and Expenditure of Professional Soccer Players of the English Premier League: Evidence of Carbohydrate Periodization.

    Science.gov (United States)

    Anderson, Liam; Orme, Patrick; Naughton, Robert J; Close, Graeme L; Milsom, Jordan; Rydings, David; O'Boyle, Andy; Di Michele, Rocco; Louis, Julien; Hambly, Catherine; Speakman, John Roger; Morgans, Ryland; Drust, Barry; Morton, James P

    2017-06-01

    In an attempt to better identify and inform the energy requirements of elite soccer players, we quantified the energy expenditure (EE) of players from the English Premier League (n = 6) via the doubly labeled water method (DLW) over a 7-day in-season period. Energy intake (EI) was also assessed using food diaries, supported by the remote food photographic method and 24 hr recalls. The 7-day period consisted of 5 training days (TD) and 2 match days (MD). Although mean daily EI (3186 ± 367 kcals) was not different from (p > .05) daily EE (3566 ± 585 kcals), EI was greater (p recovery from match play was not in accordance with guidelines to promote muscle glycogen storage.

  6. QUALITY OF NURSING WORK LIFE IMPROVEMENT MODEL TO DECREASE NURSE INTENTION TO QUIT IN PREMIER SURABAYA HOSPITAL

    Directory of Open Access Journals (Sweden)

    Jany Prihastuty

    2017-04-01

    Full Text Available Introduction: Quality of Nursing Work Life (QNWL is a thing that needs attention by human resource management approach. The purpose of this research was to provide develop model to increase QNWL in order to lower nurse’s intention to quit the Premier Hospital Surabaya. Methods: Design used in the structure was explanatory research. The independent variables was Internal factors (Individual factors, social and environment conceptual factors, operational factors, administrative factors where as the dependent variable from this study was intention to quit, and moderator variables QNWL random sampling technique. Total sample was 160 nurses, taken according to inclusion criteria. The research was conducted in Premier Hospital Surabaya from October 2012 - July 2013. Data were collected by using structured questionnaire. Data were then analyzed by using multiple linear regression test with level of significance of ≤ 0.05. Result: The results showed, QNWL was influenced by relationships inter-professional part of variabel social and environment conceptual factors, supervision monitoring part of variabel operational factors, career development part of variabel administrative factors. Intention to quit influenced by relationships between nurses, inter-departmental and inter-professional part of variabel social and environment conceptual factors and salaries and benefits part of variabel administrative factors with significant value p = 0.005. Discussion: It can be concluded good inter-professional relation, supervision monitoring, and good career development affected QNWL. Good relationships between nurses, inter-departmental and inter- professional led to lower intention to quit. Low salary and benefits led nurse’s intention to quit getting stronger.

  7. European youth care sites serve different populations of adolescents with cannabis use disorder. Baseline and referral data from the INCANT trial

    Directory of Open Access Journals (Sweden)

    Rigter Renske

    2011-07-01

    Full Text Available Abstract Background MDFT (Multidimensional Family Therapy is a family based outpatient treatment programme for adolescent problem behaviour. MDFT has been found effective in the USA in adolescent samples differing in severity and treatment delivery settings. On request of five governments (Belgium, France, Germany, the Netherlands, and Switzerland, MDFT has now been tested in the joint INCANT trial (International Cannabis Need of Treatment for applicability in Western Europe. In each of the five countries, study participants were recruited from the local population of youth seeking or guided to treatment for, among other things, cannabis use disorder. There is little information in the literature if these populations are comparable between sites/countries or not. Therefore, we examined if the study samples enrolled in the five countries differed in baseline characteristics regarding demographics, clinical profile, and treatment delivery setting. Methods INCANT was a multicentre phase III(b randomized controlled trial with an open-label, parallel group design. It compared MDFT with treatment as usual (TAU at and across sites in Berlin, Brussels, Geneva, The Hague and Paris. Participants of INCANT were adolescents of either sex, from 13 through 18 years of age, with a cannabis use disorder (dependence or abuse, and at least one parent willing to take part in the treatment. In total, 450 cases/families were randomized (concealed into INCANT. Results We collected data about adolescent and family demographics (age, gender, family composition, school, work, friends, and leisure time. In addition, we gathered data about problem behaviour (substance use, alcohol and cannabis use disorders, delinquency, psychiatric co-morbidity. There were no major differences on any of these measures between the treatment conditions (MDFT and TAU for any of the sites. However, there were cross-site differences on many variables. Most of these could be explained by

  8. The role of concurrent chemoradiotherapy in the treatment of locoregionally advanced nasopharyngeal carcinoma among endemic population: a meta-analysis of the phase iii randomized trials

    International Nuclear Information System (INIS)

    Zhang, Li; Zhao, Chong; Ghimire, Bijesh; Hong, Ming-Huang; Liu, Qing; Zhang, Yang; Guo, Ying; Huang, Yi-Jun; Guan, Zhong-Zhen

    2010-01-01

    The main objective of this meta-analysis was to determine the clinical benefit of concurrent chemoradiotherapy (CCRT) compared with radiation alone (RT) in the treatment of nasopharyngeal carcinoma (NPC) patients in endemic geographic areas. Using a prospective meta-analysis protocol, two independent investigators reviewed the publications and extracted the data. Published randomized controlled trials (RCTs) in which patients with NPC in endemic areas were randomly assigned to receive CCRT or RT alone were included. Seven trials (totally 1608 patients) were eligible. Risk ratios (RRs) of 0.63 (95% CI, 0.50 to 0.80), 0.76 (95% CI, 0.61 to 0.93) and 0.74 (95% CI, 0.62 to 0.89) were observed for 2, 3 and 5 years OS respectively in favor of the CCRT group. The RRs were larger than that detected in the previously reported meta-analyses (including both endemic and non-endemic), indicating that the relative benefit of survival was smaller than what considered before. This is the first meta-analysis of CCRT vs. RT alone in NPC treatment which included studies only done in endemic area. The results confirmed that CCRT was more beneficial compared with RT alone. However, the relative benefit of CCRT in endemic population might be less than that from previous meta-analyses

  9. A Randomized Trial to Compare Alternative Educational Interventions to Increase Colorectal Cancer Screening in a Hard-to-Reach Urban Minority Population with Health Insurance.

    Science.gov (United States)

    Basch, Charles E; Zybert, Patricia; Wolf, Randi L; Basch, Corey H; Ullman, Ralph; Shmukler, Celia; King, Fionnuala; Neugut, Alfred I; Shea, Steven

    2015-10-01

    This randomized controlled trial assessed different educational approaches for increasing colorectal cancer screening uptake in a sample of primarily non-US born urban minority individuals, over aged 50, with health insurance, and out of compliance with screening guidelines. In one group, participants were mailed printed educational material (n = 180); in a second, participants' primary care physicians received academic detailing to improve screening referral and follow-up practices (n = 185); in a third, physicians received academic detailing and participants received tailored telephone education (n = 199). Overall, 21.5% of participants (n = 121) received appropriate screening within one year of randomization. There were no statistically significant pairwise differences between groups in screening rate. Among those 60 years of age or older, however, the detailing plus telephone education group had a higher screening rate than the print group (27.3 vs. 7.7%, p = .02). Different kinds of interventions will be required to increase colorectal cancer screening among the increasingly small population segment that remains unscreened. ClinicalTrials.gov Identifier: NCT02392143.

  10. A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project

    Directory of Open Access Journals (Sweden)

    Sánchez-Gómez Luis

    2012-11-01

    Full Text Available Abstract Background This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7–8 years. Methods/design This study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7–8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30 will be randomly assigned to one of two groups: 1 Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2 Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children was calculated for a comparison of proportions with an α of 0.05 and a β of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis. Discussion The intervention providing the best results could be recommended as part of health

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

    Science.gov (United States)

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

    2017-12-22

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

  12. Paclitaxel-eluting stents versus everolimus-eluting coronary stents in a diabetic population: two-year follow-up of the TUXEDO-India trial.

    Science.gov (United States)

    Kaul, Upendra; Bhagwat, Ajit; Pinto, Brian; Goel, Praveen K; Jagtap, Prashant; Sathe, Shireesh; Wander, Gurpreet S; Arambam, Priyadarshini; Bangalore, Sripal

    2017-11-20

    The aim of this study was to report whether the superiority of the everolimus-eluting stent (EES) vs. the paclitaxel-eluting stent (PES) at one-year follow-up in the Taxus Element versus Xience Prime in a Diabetic Population (TUXEDO)-India trial was sustained at longer-term follow-up. One thousand eight hundred and thirty (1,830) patients with diabetes mellitus and coronary artery disease were randomised to EES vs. PES. Follow-up data up to two years were available in 1,701 (92.9%) patients. The primary endpoint was target vessel failure (TVF), defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischaemia-driven target vessel revascularisation (TVR). Treatment with EES had a lower two-year rate of TVF (4.3% vs. 6.6%, p=0.03). Of the secondary endpoints, EES significantly reduced any MI (1.6% vs. 3.5%, p=0.01), TV-MI (0.7% vs. 3.1%, p=0.0001), ST (0.4% vs. 2.2%, p=0.001), cardiac death or target vessel MI (2.9% vs. 4.8%, p=0.04) and TLR (1.9% vs. 3.7%, p=0.02), compared with PES. Between one year and two years, no significant differences in the clinical outcomes were observed (pinteraction >0.05). In this adequately powered trial, the benefits of EES vs. PES in a diabetic population seen at one year were maintained at two years.

  13. Field Trial of an Aerially-Distributed Tuberculosis Vaccine in a Low-Density Wildlife Population of Brushtail Possums (Trichosurus vulpecula.

    Directory of Open Access Journals (Sweden)

    Graham Nugent

    Full Text Available Oral-delivery Mycobacterium bovis bacillus Calmette-Guérin (BCG vaccine in a lipid matrix has been shown to confer protection against M. bovis infection and reduce the severity of tuberculosis (TB when fed to brushtail possums (Trichosurus vulpecula, the major wildlife vector of bovine TB in New Zealand. Here we demonstrate the feasibility of aerial delivery of this live vaccine in bait form to an M. bovis-infected wild possum population, and subsequently assess vaccine uptake and field efficacy. Pre-trial studies indicated a resident possum population at very low density (5 baits available per possum. Blood sampling conducted two months later provided some evidence of vaccine uptake. A necropsy survey conducted one year later identified a lower prevalence of culture-confirmed M. bovis infection and/or gross TB lesions among adult possums in vaccinated areas (1.1% prevalence; 95% CI, 0-3.3%, n = 92 than in unvaccinated areas (5.6%; 0.7-10.5%, n = 89; P = 0.098. Although not statistically different, the 81% efficacy in protecting possums against natural infection calculated from these data is within the range of previous estimates of vaccine efficacy in trials where BCG vaccine was delivered manually. We conclude that, with further straightforward refinement to improve free-choice uptake, aerial delivery of oral BCG vaccine is likely to be effective in controlling TB in wild possums. We briefly discuss contexts in which this could potentially become an important complementary tool in achieving national eradication of TB from New Zealand wildlife.

  14. Field Trial of an Aerially-Distributed Tuberculosis Vaccine in a Low-Density Wildlife Population of Brushtail Possums (Trichosurus vulpecula).

    Science.gov (United States)

    Nugent, Graham; Yockney, Ivor J; Whitford, E Jackie; Cross, Martin L; Aldwell, Frank E; Buddle, Bryce M

    2016-01-01

    Oral-delivery Mycobacterium bovis bacillus Calmette-Guérin (BCG) vaccine in a lipid matrix has been shown to confer protection against M. bovis infection and reduce the severity of tuberculosis (TB) when fed to brushtail possums (Trichosurus vulpecula), the major wildlife vector of bovine TB in New Zealand. Here we demonstrate the feasibility of aerial delivery of this live vaccine in bait form to an M. bovis-infected wild possum population, and subsequently assess vaccine uptake and field efficacy. Pre-trial studies indicated a resident possum population at very low density (matrix baits in weather-proof sachets could be successfully sown aerially via helicopter and were palatable to, and likely to be consumed by, a majority of wild possums under free-choice conditions. Subsequently, sachet-held lipid baits containing live BCG vaccine were sown at 3 baits/ha over a 1360 ha area, equating to >5 baits available per possum. Blood sampling conducted two months later provided some evidence of vaccine uptake. A necropsy survey conducted one year later identified a lower prevalence of culture-confirmed M. bovis infection and/or gross TB lesions among adult possums in vaccinated areas (1.1% prevalence; 95% CI, 0-3.3%, n = 92) than in unvaccinated areas (5.6%; 0.7-10.5%, n = 89); P = 0.098. Although not statistically different, the 81% efficacy in protecting possums against natural infection calculated from these data is within the range of previous estimates of vaccine efficacy in trials where BCG vaccine was delivered manually. We conclude that, with further straightforward refinement to improve free-choice uptake, aerial delivery of oral BCG vaccine is likely to be effective in controlling TB in wild possums. We briefly discuss contexts in which this could potentially become an important complementary tool in achieving national eradication of TB from New Zealand wildlife.

  15. Can an alert in primary care electronic medical records increase participation in a population-based screening programme for colorectal cancer? COLO-ALERT, a randomised clinical trial

    International Nuclear Information System (INIS)

    Guiriguet-Capdevila, Carolina; Fuentes-Peláez, Antonio; Reina-Rodríguez, Dolores; De León-Gallo, Rosa; Mendez-Boo, Leonardo; Torán-Monserrat, Pere; Muñoz-Ortiz, Laura; Rivero-Franco, Irene; Vela-Vallespín, Carme; Vilarrubí-Estrella, Mercedes; Torres-Salinas, Miquel; Grau-Cano, Jaume; Burón-Pust, Andrea; Hernández-Rodríguez, Cristina

    2014-01-01

    Colorectal cancer is an important public health problem in Spain. Over the last decade, several regions have carried out screening programmes, but population participation rates remain below recommended European goals. Reminders on electronic medical records have been identified as a low-cost and high-reach strategy to increase participation. Further knowledge is needed about their effect in a population-based screening programme. The main aim of this study is to evaluate the effectiveness of an electronic reminder to promote the participation in a population-based colorectal cancer screening programme. Secondary aims are to learn population’s reasons for refusing to take part in the screening programme and to find out the health professionals’ opinion about the official programme implementation and on the new computerised tool. This is a parallel randomised trial with a cross-sectional second stage. Participants: all the invited subjects to participate in the public colorectal cancer screening programme that includes men and women aged between 50–69, allocated to the eleven primary care centres of the study and all their health professionals. The randomisation unit will be the primary care physician. The intervention will consist of activating an electronic reminder, in the patient’s electronic medical record, in order to promote colorectal cancer screening, during a synchronous medical appointment, throughout the year that the intervention takes place. A comparison of the screening rates will then take place, using the faecal occult blood test of the patients from the control and the intervention groups. We will also take a questionnaire to know the opinions of the health professionals. The main outcome is the screening status at the end of the study. Data will be analysed with an intention-to-treat approach. We expect that the introduction of specific reminders in electronic medical records, as a tool to facilitate and encourage direct referral by

  16. REMOVAL OF CHEMICAL AND MICROBIAL CONTAMINANTS IN DRINKING WATER - WATTS PREMIER M-2400 POINT-OF-ENTRY REVERSE OSMOSIS DRINKINGWATER TREATMENT SYSTEM

    Science.gov (United States)

    The Watts Premier M-2400 POE RO Drinking Water Treatment System was tested at the NSF Drinking Water Treatment Systems Laboratory for removal of the viruses fr and MS2, the bacteria Brevundimonas diminuta, and chemicals aldicarb, benzene, cadmium, carbofuran, cesium, chl...

  17. ENVIRONMENTAL TECHNOLOGY VERIFICATION REPORT, REMOVAL OF ARSENIC IN DRINKING WATER: WATTS PREMIER M-SERIES M-15,000 REVERSE OSMOSIS TREATMENT SYSTEM

    Science.gov (United States)

    Verification testing of the Watts Premier M-Series M-15,000 RO Treatment System was conducted over a 31-day period from April 26, 2004, through May 26, 2004. This test was conducted at the Coachella Valley Water District (CVWD) Well 7802 in Thermal, California. The source water...

  18. The energy outlook in China-Minutes from the seminar organised by the Centre Geopolitique de l'Energie et des Matieres Premieres

    International Nuclear Information System (INIS)

    Keppler, J.H.; Meritet, S.

    2004-01-01

    As part of the seminars that are organised on a regular basis, the Centre de Geopolitique de l'Energie et des Matieres Premieres has devoted, on the 2. of June, a day to China, its energetics outlook and the resulting economic and geopolitical challenges. (authors)

  19. Mortality in well controlled HIV in the continuous antiretroviral therapy arms of the SMART and ESPRIT trials compared with the general population.

    Science.gov (United States)

    Rodger, Alison J; Lodwick, Rebecca; Schechter, Mauro; Deeks, Steven; Amin, Janaki; Gilson, Richard; Paredes, Roger; Bakowska, Elzbieta; Engsig, Frederik N; Phillips, Andrew

    2013-03-27

    Due to the success of antiretroviral therapy (ART), it is relevant to ask whether death rates in optimally treated HIV are higher than the general population. The objective was to compare mortality rates in well controlled HIV-infected adults in the SMART and ESPRIT clinical trials with the general population. Non-IDUs aged 20-70 years from the continuous ART control arms of ESPRIT and SMART were included if the person had both low HIV plasma viral loads (≤400 copies/ml SMART, ≤500 copies/ml ESPRIT) and high CD4(+) T-cell counts (≥350 cells/μl) at any time in the past 6 months. Standardized mortality ratios (SMRs) were calculated by comparing death rates with the Human Mortality Database. Three thousand, two hundred and eighty individuals [665 (20%) women], median age 43 years, contributed 12,357 person-years of follow-up. Sixty-two deaths occurred during follow up. Commonest cause of death was cardiovascular disease (CVD) or sudden death (19, 31%), followed by non-AIDS malignancy (12, 19%). Only two deaths (3%) were AIDS-related. Mortality rate was increased compared with the general population with a CD4(+) cell count between 350 and 499 cells/μl [SMR 1.77, 95% confidence interval (CI) 1.17-2.55]. No evidence for increased mortality was seen with CD4(+) cell counts greater than 500 cells/μl (SMR 1.00, 95% CI 0.69-1.40). In HIV-infected individuals on ART, with a recent undetectable viral load, who maintained or had recovery of CD4(+) cell counts to at least 500 cells/μl, we identified no evidence for a raised risk of death compared with the general population.

  20. Implementing an Internet-Delivered Skin Cancer Genetic Testing Intervention to Improve Sun Protection Behavior in a Diverse Population: Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Hay, Jennifer L; Berwick, Marianne; Zielaskowski, Kate; White, Kirsten Am; Rodríguez, Vivian M; Robers, Erika; Guest, Dolores D; Sussman, Andrew; Talamantes, Yvonne; Schwartz, Matthew R; Greb, Jennie; Bigney, Jessica; Kaphingst, Kimberly A; Hunley, Keith; Buller, David B

    2017-04-25

    Limited translational genomic research currently exists to guide the availability, comprehension, and appropriate use of personalized genomics in diverse general population subgroups. Melanoma skin cancers are preventable, curable, common in the general population, and disproportionately increasing in Hispanics. Variants in the melanocortin-1 receptor (MC1R) gene are present in approximately 50% of the population, are major factors in determining sun sensitivity, and confer a 2-to-3-fold increase in melanoma risk in the general population, even in populations with darker skin. Therefore, feedback regarding MC1R risk status may raise risk awareness and protective behavior in the general population. We are conducting a randomized controlled trial examining Internet presentation of the risks and benefits of personalized genomic testing for MC1R gene variants that are associated with increased melanoma risk. We will enroll a total of 885 participants (462 participants are currently enrolled), who will be randomized 6:1 to personalized genomic testing for melanoma risk versus waiting list control. Control participants will be offered testing after outcome assessments. Participants will be balanced across self-reported Hispanic versus non-Hispanic ethnicity (n=750 in personalized genomic testing for melanoma risk arm; n=135 in control arm), and will be recruited from a general population cohort in Albuquerque, New Mexico, which is subject to year-round sun exposure. Baseline surveys will be completed in-person with study staff and follow-up measures will be completed via telephone. Aim 1 of the trial will examine the personal utility of personalized genomic testing for melanoma risk in terms of short-term (3-month) sun protection and skin screening behaviors, family and physician communication, and melanoma threat and control beliefs (ie, putative mediators of behavior change). We will also examine potential unintended consequences of testing among those who receive

  1. A randomized trial of family focused therapy with populations at clinical high risk for psychosis: effects on interactional behavior.

    Science.gov (United States)

    O'Brien, Mary P; Miklowitz, David J; Candan, Kristin A; Marshall, Catherine; Domingues, Isabel; Walsh, Barbara C; Zinberg, Jamie L; De Silva, Sandra D; Woodberry, Kristen A; Cannon, Tyrone D

    2014-02-01

    This study investigated whether family focused therapy (FFT-CHR), an 18-session intervention that consisted of psychoeducation and training in communication and problem solving, brought about greater improvements in family communication than enhanced care (EC), a 3-session psychoeducational intervention, among individuals at clinical high risk for developing psychosis. This study was conducted within a randomized controlled trial across 8 sites. We examined 10-min problem-solving discussions at baseline and 6-month reassessment among 66 adolescents and young adults and their parents. Trained coders who were blind to treatment and time of assessment achieved high levels of interrater reliability when evaluating family discussions on categories of calm-constructive and critical-conflictual behavior. Individuals at high risk and their family members who participated in FFT-CHR demonstrated greater improvement from baseline to 6-month reassessment in constructive communication and decreases in conflictual behaviors during family interactions than those in EC. Participants in FFT-CHR showed greater increases from baseline to 6 months in active listening and calm communication and greater decreases in irritability and anger, complaints and criticism, and off-task comments compared to participants in EC. These changes occurred equally in high-risk participants and their family members. A 6-month family skills training treatment can bring about significant improvement in family communication among individuals at high risk for psychosis and their parents. Future studies should examine the association between enhancements in family communication and reduced risk for the onset of psychosis among individuals at high risk. PsycINFO Database Record (c) 2014 APA, all rights reserved.

  2. Randomized Trial of a Children's Book Versus Brochures for Safe Sleep Knowledge and Adherence in a High-Risk Population.

    Science.gov (United States)

    Hutton, John S; Gupta, Resmi; Gruber, Rachel; Berndsen, Jennifer; DeWitt, Thomas; Ollberding, Nicholas J; Van Ginkel, Judith B; Ammerman, Robert T

    Sleep-related infant deaths have plateaued in the past decade, disproportionately affecting low socioeconomic status (SES) families. Printed materials are widely used for anticipatory guidance, yet none for safe sleep has been studied. We tested the efficacy of a specially designed children's book compared to brochures for safe sleep knowledge and adherence, which we hypothesized would be greater due to superior readability and engagement. This randomized controlled trial involved low-SES mothers (n = 282) enrolled in a home visiting program. Home visitors (n = 56) were randomly assigned to perform safe sleep teaching and assessments during 3 visits: third trimester, 1 week old, and 2 months old, exclusively utilizing a specially designed children's book or brochures, and surveys incorporating the American Academy of Pediatrics' safe sleep recommendations. Outcomes were safe sleep knowledge, adherence, and usefulness of materials, controlling for maternal health literacy. Safe sleep knowledge increased across all time points with no overall group difference, though gains for sleep-evocative and general health items varied. Odds of bed sharing were higher and exclusive crib use lower for the brochure group (P book and mothers in the book group reported more book sharing with their baby. While a specially designed children's book and brochures were equally effective conveying aggregate safe sleep knowledge in low-SES mothers, adherence to exclusive crib use and avoiding bed sharing were greater in the book group, attributable to enhanced dialogue, readability and emotional engagement. Children's books are a promising mode of anticipatory guidance, warranting further investigation. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

  3. Clinical Trials

    Medline Plus

    Full Text Available ... Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ... Activity Population and Epidemiology Studies Women’s Health All Science A-Z Grants ... in the Press Research Features All Events Past Events Upcoming ...

  4. Clinical Trials

    Medline Plus

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

  5. Dabigatran for anticoagulation in atrial fibrillation - early clinical experience in a hospital population and comparison to trial data.

    Science.gov (United States)

    Michel, Jonathan; Mundell, David; Boga, Tau; Sasse, Alexander

    2013-01-01

    Dabigatran is a recently introduced direct thrombin inhibitor licensed for use as an oral anticoagulant for stroke prevention in non-valvular atrial fibrillation. Our prospective observational study aimed to assess the adverse effects, tolerability and patient satisfaction of dabigatran therapy in a hospital-practice population. Patients starting dabigatran, after its release in June 2011, were identified from clinical practice at two Wellington hospitals, New Zealand. Baseline characteristics were recorded from the clinical record and a telephone interview was performed in January 2012. Primary outcomes included adverse events, adherence, and satisfaction with treatment. Data were available for 70 patients: median age 71.9 years (IQR 62.7-79.0), weight 80 kg (IQR 71-95), CHA(2)DS(2)-VASc score 3 (IQR 2-4). Seventy-one percent of patients reported adverse events although the majority were minor. Twenty-four percent (16/70) had discontinued treatment with dabigatran; four due to predominantly gastrointestinal side effects, three due to bleeding (one severe), one as a result of adverse media coverage with the remainder comprising planned treatment discontinuation and undetermined. In total, 29% reported bleeding events, predominantly minor bleeding and bruising. There were no cerebrovascular events. Nineteen percent reported some difficulty with twice daily dosing adherence with 13 of 70 reporting missed doses. Seventy-seven percent reported treatment satisfaction and 79% of those previously treated with warfarin preferred dabigatran. In this population our study demonstrates a discontinuation rate of 10% due to side effects of dabigatran, similar to the rate reported in RE-LY. The majority of patients are satisfied with their treatment and preferred dabigatran to warfarin, mainly due to the reduced requirement for blood testing. Copyright © 2012 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and

  6. Informing resource-poor populations and the delivery of entitled health and social services in rural India: a cluster randomized controlled trial.

    Science.gov (United States)

    Pandey, Priyanka; Sehgal, Ashwini R; Riboud, Michelle; Levine, David; Goyal, Madhav

    2007-10-24

    A lack of awareness about entitled health and social services may contribute to poor delivery of such services in developing countries, especially among individuals of low socioeconomic status. To determine the impact of informing resource-poor rural populations about entitled services. Community-based, cluster randomized controlled trial conducted from May 2004 to May 2005 in 105 randomly selected village clusters in Uttar Pradesh state in India. Households (548 intervention and 497 control) were selected by a systematic sampling design, including both low-caste and mid- to high-caste households. Four to 6 public meetings were held in each intervention village cluster to disseminate information on entitled health services, entitled education services, and village governance requirements. No intervention took place in control village clusters. Visits by nurse midwife; prenatal examinations, tetanus vaccinations, and prenatal supplements received by pregnant women; vaccinations received by infants; excess school fees charged; occurrence of village council meetings; and development work in villages. At baseline, there were no significant differences in self-reported delivery of health and social services. After 1 year, intervention villagers reported better delivery of several services compared with control villagers: in a multivariate analysis, 30% more prenatal examinations (95% confidence interval [CI], 17%-43%; P India about entitled services enhanced the delivery of health and social services among both low- and mid- to high-caste households. Interventions that emphasize educating resource-poor populations about entitled services may improve the delivery of such services. clinicaltrials.gov Identifier: NCT00421291.

  7. Randomized Controlled Trial for Helicobacter pylori Eradication in a Naive Portuguese Population: Is Sequential Treatment Superior to Triple Therapy in Real World Clinical Setting?

    Science.gov (United States)

    Boal Carvalho, Pedro; Magalhães, Joana; Dias de Castro, Francisca; Rosa, Bruno; Cotter, José

    2017-03-31

    Helicobacter pylori eradication has become increasingly difficult as resistances to several antibiotics develop. We aimed to compare Helicobacter pylori eradication rates between triple therapy and sequential therapy in a naive Portuguese population. Prospective randomized trial including consecutive patients referred for first-line Helicobacter pylori eradication treatment. previous gastric surgery/neoplasia, pregnancy/lactancy, allergy to any of the drugs. The compared eradication regimens were triple therapy (pantoprazol, amoxicillin and clarithromycin 12/12 hours, 14 days) and sequential therapy (pantoprazol 12/12 hours for 10 days, amoxicillin 12/12 hours for days 1 - 5 and clarithromycin plus metronidazol 12/12 hours during days 6 - 10). Eradication success was confirmed with urea breath test. Statistical analysis was performed with SPSS v21.0 and a p-value population, we found a satisfactory global Helicobacter pylori eradication rate of 82%, with no statistical differences observed in the efficacy of the treatment between triple and sequential regimens. These results support the use of either therapy for the first-line eradication of Helicobacter pylori.

  8. Six-month trial of bupropion with contingency management for cocaine dependence in a methadone-maintained population.

    Science.gov (United States)

    Poling, James; Oliveto, Alison; Petry, Nancy; Sofuoglu, Mehmet; Gonsai, Kishorchandra; Gonzalez, Gerardo; Martell, Bridget; Kosten, Thomas R

    2006-02-01

    No effective pharmacotherapies exist for cocaine dependence, although contingency management (CM) has demonstrated efficacy. To compare the efficacy of bupropion hydrochloride and CM for reducing cocaine use in methadone hydrochloride-maintained individuals. This 25-week, placebo-controlled, double-blind trial randomly assigned participants to 1 of 4 treatment conditions: CM and placebo (CMP), CM and 300 mg/d of bupropion hydrochloride (CMB), voucher control and placebo (VCP), or voucher control and bupropion (VCB). Outpatient clinic at the Veterans Affairs Connecticut Healthcare System. A total of 106 opiate-dependent, cocaine-abusing individuals. All study participants received methadone hydrochloride (range, 60-120 mg). Participants receiving bupropion hydrochloride were given 300 mg/d beginning at week 3. In the CM conditions, each urine sample negative for both opioids and cocaine resulted in a monetary-based voucher that increased for consecutively drug-free urine samples during weeks 1 to 13. Completion of abstinence-related activities also resulted in a voucher. During weeks 14 to 25, only completion of activities was reinforced in the CM group, regardless of sample results. The voucher control groups received vouchers for submitting urine samples, regardless of results, throughout the study. Thrice-weekly urine toxicologic test results for cocaine and heroin. Groups did not differ in baseline characteristics or retention rates. Opiate use decreased significantly, with all treatment groups attaining equivalent amounts of opiate use at the end of the study. In the CMB group, the proportion of cocaine-positive samples significantly decreased during weeks 3 to 13 (P<.001) relative to week 3 and remained low during weeks 14 to 25. In the CMP group, cocaine use significantly increased during weeks 3 to 13 (P<.001) relative to week 3, but then cocaine use significantly decreased relative to the initial slope during weeks 14 to 25 (P<.001). In contrast, by

  9. European youth care sites serve different populations of adolescents with cannabis use disorder. Baseline and referral data from the INCANT trial.

    Science.gov (United States)

    Phan, Olivier; Henderson, Craig E; Angelidis, Tatiana; Weil, Patricia; van Toorn, Manja; Rigter, Renske; Soria, Cecilia; Rigter, Henk

    2011-07-12

    MDFT (Multidimensional Family Therapy) is a family based outpatient treatment programme for adolescent problem behaviour. MDFT has been found effective in the USA in adolescent samples differing in severity and treatment delivery settings. On request of five governments (Belgium, France, Germany, the Netherlands, and Switzerland), MDFT has now been tested in the joint INCANT trial (International Cannabis Need of Treatment) for applicability in Western Europe. In each of the five countries, study participants were recruited from the local population of youth seeking or guided to treatment for, among other things, cannabis use disorder. There is little information in the literature if these populations are comparable between sites/countries or not. Therefore, we examined if the study samples enrolled in the five countries differed in baseline characteristics regarding demographics, clinical profile, and treatment delivery setting. INCANT was a multicentre phase III(b) randomized controlled trial with an open-label, parallel group design. It compared MDFT with treatment as usual (TAU) at and across sites in Berlin, Brussels, Geneva, The Hague and Paris.Participants of INCANT were adolescents of either sex, from 13 through 18 years of age, with a cannabis use disorder (dependence or abuse), and at least one parent willing to take part in the treatment. In total, 450 cases/families were randomized (concealed) into INCANT. We collected data about adolescent and family demographics (age, gender, family composition, school, work, friends, and leisure time). In addition, we gathered data about problem behaviour (substance use, alcohol and cannabis use disorders, delinquency, psychiatric co-morbidity).There were no major differences on any of these measures between the treatment conditions (MDFT and TAU) for any of the sites. However, there were cross-site differences on many variables. Most of these could be explained by variations in treatment culture, as reflected by

  10. The Mobile Insulin Titration Intervention (MITI) for Insulin Adjustment in an Urban, Low-Income Population: Randomized Controlled Trial.

    Science.gov (United States)

    Levy, Natalie; Moynihan, Victoria; Nilo, Annielyn; Singer, Karyn; Bernik, Lidia S; Etiebet, Mary-Ann; Fang, Yixin; Cho, James; Natarajan, Sundar

    2015-07-17

    Diabetes patients are usually started on a low dose of insulin and their dose is adjusted or "titrated" according to their blood glucose levels. Insulin titration administered through face-to-face visits with a clinician can be time consuming and logistically burdensome for patients, especially those of low socioeconomic status (SES). Given the wide use of mobile phones among this population, there is the potential to use short message service (SMS) text messaging and phone calls to perform insulin titration remotely. The goals of this pilot study were to (1) evaluate if our Mobile Insulin Titration Intervention (MITI) intervention using text messaging and phone calls was effective in helping patients reach their optimal insulin glargine dose within 12 weeks, (2) assess the feasibility of the intervention within our clinic setting and patient population, (3) collect data on the cost savings associated with the intervention, and (4) measure patient satisfaction with the intervention. This was a pilot study evaluating an intervention for patients requiring insulin glargine titration in the outpatient medical clinic of Bellevue Hospital Center in New York City. Patients in the intervention arm received weekday SMS text messages from a health management platform requesting their fasting blood glucose values. The clinic's diabetes nurse educator monitored the texted responses on the platform website each weekday for alarm values. Once a week, the nurse reviewed the glucose values, consulted the MITI titration algorithm, and called patients to adjust their insulin dose. Patients in the usual care arm continued to receive their standard clinic care for insulin titration. The primary outcome was whether a patient reached his/her optimal insulin glargine dose within 12 weeks. A total of 61 patients consented and were randomized into the study. A significantly greater proportion of patients in the intervention arm reached their optimal insulin glargine dose than patients in

  11. The effect of exercise on prescription on physical activity and wellbeing in a multi-ethnic female population: A controlled trial.

    Science.gov (United States)

    Gademan, Maaike G J; Deutekom, Marije; Hosper, Karen; Stronks, Karien

    2012-09-10

    In Western countries, individuals from multi-ethnic disadvantaged populations are less physically active than the Western population as a whole. This lack of physical activity (PA) may be one of the factors explaining disparities in health. Exercise on Prescription" (EoP), is an exercise program to which persons are referred by primary care. It has been developed to suit the needs of physically inactive women from diverse ethnic backgrounds living in deprived neighborhoods in the Netherlands. The effectiveness of this program has however, not yet been proven. A total of 514 women from diverse ethnic backgrounds were included in this study (192 EoP, 322 control group). Women in the EoP group participated in 18 sessions of supervised PA. The control group received care as usual. At baseline, 6 and 12 months the women attended an interview and a physical examination. Outcome measures were PA, BMI, weight circumference, fat percentage, oxygen uptake, mental well-being, subjective health and use of care. Of the participants 59% had a low educational level and 90% of the women were overweight or obese. Compliance was high, only 14% dropped out during the course of the program. Total PA did not change, PA during leisure time increased at 6 and at 12 months and PA during household activities increased at 12 months (PEoPvsControl < 0.05). EoP had no significant effect on the other outcome variables. EoP was successful in recruiting its target population and compliance was high. The effect of EoP on PA, health and mental well-being was limited. In this format EoP does not seem to be effective for increasing PA and the health status of non-Western migrant women. Dutch Trial register: NTR1294.

  12. Cost-effectiveness of population-based vascular disease screening and intervention in men from the Viborg Vascular (VIVA) trial

    DEFF Research Database (Denmark)

    Søgaard, R.; Lindholt, J. S.

    2018-01-01

    ), and the effectiveness at 0·022 (95 per cent c.i. 0·006 to 0·038) life-years and 0·069 (0·054 to 0·083) QALYs, generating average costs of €6872 per life-year and €2148 per QALY. At a willingness-to-pay threshold of €40000 per QALY, the probabilities of cost-effectiveness were 98 and 99 per cent respectively......Background: Population-based screening and intervention for abdominal aortic aneurysm, peripheral artery disease and hypertension was recently reported to reduce the relative risk of mortality among Danish men by 7 per cent. The aim of this study was to investigate the cost-effectiveness...... of vascular screening versus usual care (ad hoc primary care-based risk assessment) from a national health service perspective. Methods: A cost-effectiveness evaluation was conducted alongside an RCT involving all men from a region in Denmark (50156) who were allocated to screening (25078) or no screening...

  13. The 50/50 cc Total Artificial Heart Trial: Extending the Benefits of the Total Artificial Heart to Underserved Populations.

    Science.gov (United States)

    Wells, Dennis; Villa, Chet R; Simón Morales, David Luís

    2017-01-01

    While use of the total artificial heart (TAH) is growing, the use of the device is not uniform across the gender and age spectrum because the vast majority of implants are in adult males. SynCardia has recently developed a smaller 50 cc TAH that was designed to accommodate patients with a body surface area as low as 1.2 m 2 (potentially even lower using virtual implantation). Herein, we describe the early use of the 50 cc TAH (10 implants in the US and 18 outside the US). Twenty-eight devices have been implanted worldwide. Nineteen (68%) patients were female, 4 (14%) were 21 years of age or younger, and 2 (7%) had a diagnosis of congenital heart disease (1 Fontan). The smallest patient, by body surface area, was 1.35 m 2 . Six patients (21%) have been placed on the Freedom Driver, all of whom have survived. Fourteen patients (50%) have had a positive outcome to date. The development of the 50 cc TAH has expanded the population of patients who may benefit from TAH support and thus may help improve outcomes for patients who have had limited biventricular support options to date. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Pre-exposure prophylaxis for the prevention of HIV infection in high risk populations: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Junjun Jiang

    Full Text Available Nearly ten randomized controlled trials (RCTs of pre-exposure prophylaxis (PrEP have been completed or are ongoing worldwide to evaluate the effectiveness of PrEP in HIV transmission among HIV-uninfected high risk populations. The purpose of this study was to evaluate the role of PrEP to prevent HIV transmission through a Mata-analysis.A comprehensive computerized literature search was carried out in PubMed, EMbase, Ovid, Web of Science, Science Direct, Wan Fang, CNKI and related websites to collect relevant articles (from their establishment date to August 30, 2013. The search terms were "pre-exposure prophylaxis", "high risk population", "HIV infection", "reduction", "relative risk" and "efficacy". We included any RCT assessing PrEP for the prevention of HIV infection in high risk populations. Interventions of the studies were continuously daily or intermittent doses of single or compound antiretrovirals (ARVs before HIV exposure or during HIV exposure. A meta-analysis was conducted using Stata 10.0. A random-effects method was used to calculate the pooled relative risk (RR and 95% confidence intervals (CI for all studies included.Seven RCTs involving 14,804 individuals in high risk populations were eligible for this study. The number of subjects in the experimental groups was 8,195, with HIV infection rate of 2.03%. The number of subjects in the control groups was 6,609, with HIV infection rate of 4.07%. The pooled RR was 0.53 (95% CI = 0.40 ∼ 0.71, P<0.001. The re-analyzed pooled RR were 0.61 (95% CI = 0.48 ∼ 0.77, P<0.001, 0.49 (95% CI = 0.38 ∼ 0.63, P<0.001, respectively, by excluding the largest study or two studies without statistical significance. Publication bias analysis revealed a symmetry funnel plot. The fail-safe number was 1,022.These results show that PrEP is an effective strategy for reducing new HIV infections in high risk populations.

  15. Les marqueurs d'aspect de dicto : 'à première vue', 'au premier abord', 'de prime abord'

    Directory of Open Access Journals (Sweden)

    Lenepveu Véronique

    2012-07-01

    Full Text Available On se propose d’étudier les locutions adverbiales "à première vue", "au premier abord", "de prime abord", trois locutions qui comportent une forme numérale ordinale et qui entretiennent des relations de proximité sémantique. Nous nous intéressons précisément au fonctionnement sémantique et pragmatique de ces locutions à valeur paradigmatisante (Nølke 1983, quand elles introduisent un point de vue (Anscombre & Ducrot 1983, Ducrot 1984, Nølke 1994. Dans cette perspective, nous faisons l’hypothèse d’un procès énonciatif, qui consiste à prendre en considération une situation, et qui vise à constituer un jugement stabilisé. Nous admettons alors que les locutions adverbiales 'à première vue', 'au premier abord', 'de prime abord', servent à sélectionner la phase initiale de ce procès énonciatif, ce qu’attestent les mises en corrélation possibles des trois marqueurs de point de vue avec des expressions qui signalent une évolution dans le temps du jugement du locuteur concernant une situation ('à mieux regarder', 'à y regarder de plus près', 'tout compte fait', 'tout bien considéré', .... L’étude de ces enchaînements, qui vont parfois au-delà du paragraphe, fait apparaître la capacité des trois locutions à initier un cadre (Charolles 1997, et à appeler un autre cadre dans lequel le jugement va être réévalué. En présentant le point de vue qu’elle introduit comme provisoire et en attente de confirmation, chacune de ces locutions anticipe ainsi sur la suite du texte, et s’inscrit dans une structure aspectuelle de dicto qui est celle d’un procès énonciatif de constitution d’un jugement stabilisé. Nous nous appuyons sur des énoncés attestés au XXème, sélectionnés sur "Frantext intégral", ou bien choisis dans Le Monde sur cederom (1995-96, 1999-2002.

  16. The Children and Parents in Focus project: a population-based cluster-randomised controlled trial to prevent behavioural and emotional problems in children.

    Science.gov (United States)

    Salari, Raziye; Fabian, Helena; Prinz, Ron; Lucas, Steven; Feldman, Inna; Fairchild, Amanda; Sarkadi, Anna

    2013-10-16

    There is large body of knowledge to support the importance of early interventions to improve child health and development. Nonetheless, it is important to identify cost-effective blends of preventive interventions with adequate coverage and feasible delivery modes. The aim of the Children and Parents in Focus trial is to compare two levels of parenting programme intensity and rate of exposure, with a control condition to address impact and cost-effectiveness of a universally offered evidence-based parenting programme in the Swedish context. The trial has a cluster randomised controlled design comprising three arms: Universal arm (with access to participation in Triple P - Positive Parenting Program, level 2); Universal Plus arm (with access to participation in Triple P - Positive Parenting Program, level 2 as well as level 3, and level 4 group); and Services as Usual arm. The sampling frame is Uppsala municipality in Sweden. Child health centres consecutively recruit parents of children aged 3 to 5 years before their yearly check-ups (during the years 2013-2017). Outcomes will be measured annually. The primary outcome will be children's behavioural and emotional problems as rated by three informants: fathers, mothers and preschool teachers. The other outcomes will be parents' behaviour and parents' general health. Health economic evaluations will analyse cost-effectiveness of the interventions versus care as usual by comparing the costs and consequences in terms of impact on children's mental health, parent's mental health and health-related quality of life. This study addresses the need for comprehensive evaluation of the long-term effects, costs and benefits of early parenting interventions embedded within existing systems. In addition, the study will generate population-based data on the mental health and well-being of preschool aged children in Sweden. ISRCTN16513449.

  17. Study protocol: a double blind randomised control trial of high volume image guided injections in Achilles and patellar tendinopathy in a young active population.

    Science.gov (United States)

    Barker-Davies, Robert M; Nicol, Alastair; McCurdie, I; Watson, James; Baker, Polly; Wheeler, Patrick; Fong, Daniel; Lewis, Mark; Bennett, Alexander N

    2017-05-22

    Chronic tendinopathy is a significant problem particularly in active populations limiting sporting and occupational performance. The prevalence of patellar tendinopathy in some sports is near 50% and the incidence of lower limb tendinopathy is 1.4% p.a. in the UK Military. Management includes isometric, eccentric, heavy slow resistance exercises and extracorporeal shockwave therapy (ESWT). Often these treatments are inadequate yet there is no good evidence for injection therapies and success rates from surgery can be as low as 50%. High Volume Image Guided Injection (HVIGI) proposes to strip away the neovascularity and disrupt the nerve ingrowth seen in chronic cases and has shown promising results in case series. This study aims to investigate the efficacy of HVIGI in a randomised controlled trial (RCT). RCT comparing 40ml HVIGI, with or without corticosteroid, with a 3ml local anaesthetic sham-control injection. Ninety-six participants will be recruited. male, 18-55 years old, chronic Achilles or patellar tendinopathy of at least 6 months, failed conservative management including ESWT, and Ultrasound (US) evidence of neovascularisation, tendon thickening and echogenic changes. Outcome measures will be recorded at baseline, 6 weeks, 3, 6 and 12 months. Primary outcome measures include The Victoria Institute of Sport Assessments for Achilles and patellar tendinopathy (VISA-A and VISA-P) and VAS pain. Secondary outcome measures include Modified Ohberg score, maximum tendon diameter and assessment of hypoechoic appearance on US, and Functional Activity Assessment. Despite previous interventional trials and reviews there is still insufficient evidence to guide injectable therapy for chronic tendinopathy that has failed conservative treatment. The scant evidence available suggests HVIGI has the greatest potential however there is no level one RCT evidence to support this. Investigating the efficacy of HVIGI against control in a RCT and separating the effect of HVIGI

  18. Comparison of population-averaged and cluster-specific models for the analysis of cluster randomized trials with missing binary outcomes: a simulation study

    Directory of Open Access Journals (Sweden)

    Ma Jinhui

    2013-01-01

    Full Text Available Abstracts Background The objective of this simulation study is to compare the accuracy and efficiency of population-averaged (i.e. generalized estimating equations (GEE and cluster-specific (i.e. random-effects logistic regression (RELR models for analyzing data from cluster randomized trials (CRTs with missing binary responses. Methods In this simulation study, clustered responses were generated from a beta-binomial distribution. The number of clusters per trial arm, the number of subjects per cluster, intra-cluster correlation coefficient, and the percentage of missing data were allowed to vary. Under the assumption of covariate dependent missingness, missing outcomes were handled by complete case analysis, standard multiple imputation (MI and within-cluster MI strategies. Data were analyzed using GEE and RELR. Performance of the methods was assessed using standardized bias, empirical standard error, root mean squared error (RMSE, and coverage probability. Results GEE performs well on all four measures — provided the downward bias of the standard error (when the number of clusters per arm is small is adjusted appropriately — under the following scenarios: complete case analysis for CRTs with a small amount of missing data; standard MI for CRTs with variance inflation factor (VIF 50. RELR performs well only when a small amount of data was missing, and complete case analysis was applied. Conclusion GEE performs well as long as appropriate missing data strategies are adopted based on the design of CRTs and the percentage of missing data. In contrast, RELR does not perform well when either standard or within-cluster MI strategy is applied prior to the analysis.

  19. Remote population-based intervention for disruptive behavior at age four: study protocol for a randomized trial of Internet-assisted parent training (Strongest Families Finland-Canada)

    Science.gov (United States)

    2013-01-01

    Background Oppositional Defiant Disorder (ODD) is characterized by angry and noncompliant behaviour. It is the most common disruptive behaviour disorder (DBD), with prevalence estimates of 6-9% for preschoolers and is closely linked to several long-term difficulties, including disorders of conduct, mood, anxiety, impulse-control, and substance abuse. ODD in children is related to parental depression, family dysfunction, and impairments in parental work performance. Children displaying early DBDs exhibit more symptoms of greater severity, more frequent offences, and commit more serious crimes later in life. The goal of the Strongest Families™ Finland Canada (SFFC) Smart Website intervention research program is to develop and evaluate an affordable, accessible, effective secondary prevention parent training program for disruptive behaviour in preschoolers to prevent the negative sequelae of ODD. Strongest Families is an 11-session program with two booster sessions that focuses on teaching skills to: strengthen parent–child relationships; reinforce positive behaviour; reduce conflict; manage daily transitions; plan for potentially problematic situations; promote emotional regulation and pro-social behaviour and decrease antisocial behaviour. Methods/design This protocol paper describes an ongoing population-based randomized controlled trial (RCT) of high-risk 4 year-olds attending well-child clinics in Turku, Finland and environs to examine the effectiveness of the Strongest Families Smart Website intervention compared to an Education Control condition. Randomization consists of a 1:1 ratio for intervention versus the education group, stratified by the child’s sex. The participants randomized to the intervention group receive access to the Strongest Families Smart Website and weekly telephone coaching sessions. The participants randomized to the Education Control condition receive access to a static website with parenting tips. Children are followed using

  20. A web- and mobile phone-based intervention to prevent obesity in 4-year-olds (MINISTOP): a population-based randomized controlled trial.

    Science.gov (United States)

    Delisle, Christine; Sandin, Sven; Forsum, Elisabet; Henriksson, Hanna; Trolle-Lagerros, Ylva; Larsson, Christel; Maddison, Ralph; Ortega, Francisco B; Ruiz, Jonatan R; Silfvernagel, Kristin; Timpka, Toomas; Löf, Marie

    2015-02-07

    Childhood obesity is an increasing health problem globally. Overweight and obesity may be established as early as 2-5 years of age, highlighting the need for evidence-based effective prevention and treatment programs early in life. In adults, mobile phone based interventions for weight management (mHealth) have demonstrated positive effects on body mass, however, their use in child populations has yet to be examined. The aim of this paper is to report the study design and methodology of the MINSTOP (Mobile-based Intervention Intended to Stop Obesity in Preschoolers) trial. A two-arm, parallel design randomized controlled trial in 300 healthy Swedish 4-year-olds is conducted. After baseline measures, parents are allocated to either an intervention- or control group. The 6- month mHealth intervention consists of a web-based application (the MINSTOP app) to help parents promote healthy eating and physical activity in children. MINISTOP is based on the Social Cognitive Theory and involves the delivery of a comprehensive, personalized program of information and text messages based on existing guidelines for a healthy diet and active lifestyle in pre-school children. Parents also register physical activity and intakes of candy, soft drinks, vegetables as well as fruits of their child and receive feedback through the application. Primary outcomes include body fatness and energy intake, while secondary outcomes are time spent in sedentary, moderate, and vigorous physical activity, physical fitness and intakes of fruits and vegetables, snacks, soft drinks and candy. Food and energy intake (Tool for Energy balance in Children, TECH), body fatness (pediatric option for BodPod), physical activity (Actigraph wGT3x-BT) and physical fitness (the PREFIT battery of five fitness tests) are measured at baseline, after the intervention (six months after baseline) and at follow-up (12 months after baseline). This novel study will evaluate the effectiveness of a mHealth program for

  1. Cost effectiveness of a multi-stage return to work program for workers on sick leave due to low back pain, design of a population based controlled trial [ISRCTN60233560

    NARCIS (Netherlands)

    Steenstra, I.A.; Anema, J.R.; Bongers, P.M.; Vet, H.C.W. de; Mechelen, W. van

    2003-01-01

    Background: To describe the design of a population based randomized controlled trial (RCT), including a cost-effectiveness analysis, comparing participative ergonomics interventions between 2-8 weeks of sick leave and Graded Activity after 8 weeks of sick leave with usual care, in occupational back

  2. A health dialogue intervention reduces cardiovascular risk factor levels: a population based randomised controlled trial in Swedish primary care setting with 1-year follow-up

    Directory of Open Access Journals (Sweden)

    Mats Hellstrand

    2017-08-01

    Full Text Available Abstract Background The total number of cardiovascular (CVD deaths accounted for almost a third of all deaths globally in 2013. Population based randomised controlled trials, managed within primary care, on CVD risk factor interventions are scarce. The aim of the study was to evaluate the effects of a health dialogue intervention in a primary care setting offered to a population at the age of 55 years, focusing on CVD risk factors. Methods The study was performed in five primary health care centres in the county of Västmanland, Sweden between April 2011 and December 2012. Men and women were randomly assigned to intervention (n = 440 and control groups (n = 440. At baseline, both groups filled in a health questionnaire and serum cholesterol, fasting plasma glucose, glycated haemoglobin (HbA1c, weight, height, waist (WC and hip circumference, waist hip ratio (WHR and systolic/diastolic blood pressure were measured. Intervention group attended a health dialogue, supported by a visualised health profile, with a possibility for further activities. Participation rates at baseline were 53% and 52% respectively. A 1-year follow-up was carried out. Results The intervention group (n = 165 showed reductions compared to the control group (n = 177 concerning body mass index (BMI (0.3 kg/m2, p = .031, WC (2.1 cm, p ≤ .001 and WHR (.002, p ≤ .001 at the 1-year follow-up. No differences between the intervention and control groups were found in other variables. Intervention group, compared to baseline, had reduced weight, BMI, WC, WHR, HbA1c, and diet, while the men in the control group had reduced their alcohol consumption. Conclusions A health dialogue intervention at the age of 55 years, conducted in ordinary primary care, showed a moderate effect on CVD risk factor levels, in terms of BMI, WC and WHR. Trial registration number BioMed Central, ISRCTN22586871 , date assigned; 10/12/2015

  3. The key numbers of the mineral raw materials; Les chiffres cles des matieres premieres minerales

    Energy Technology Data Exchange (ETDEWEB)

    Mandil, C. [Directeur General de l`Energie et des Matieres Premieres, France (France)]|[Ministere de l`Industrie, des Postes et Telecommunications et du Commerce Exterieur, 75 - Paris (France)

    1996-12-31

    Mineral raw materials come from fossil reserves or ores resulting from the geologic and climatic history of the Earth. The access to economic development for 80% of the worldwide population and the high rate of demographic growth (probably 8 billions of inhabitants in 2025) are important factors that can greatly multiply the worldwide consumption of ores. In parallel, environmental concerns and the increasing need for a better equilibrium between wildlife preservation and the supply of economic needs, lead to a more reasonable and mastered use of natural resources. The aim of this book is to shade light and give global elements of thoughts on mineral resources, and for the main of those (about 30 metals and mineral substances), to review the most useful data and references about their production and consumption. For each question, chapters are devoted to the situation of France in its worldwide context. One chapter concerns the uranium ores (reserves, production, prices evolution, consumption, economic flux and companies involved). (J.S.).

  4. ALIFE@Work: a randomised controlled trial of a distance counselling lifestyle programme for weight control among an overweight working population [ISRCTN04265725

    Directory of Open Access Journals (Sweden)

    Hendriksen Ingrid JM

    2006-05-01

    Full Text Available Abstract Background The prevalence of overweight is increasing and its consequences will cause a major public health burden in the near future. Cost-effective interventions for weight control among the general population are therefore needed. The ALIFE@Work study is investigating a novel lifestyle intervention, aimed at the working population, with individual counselling through either phone or e-mail. This article describes the design of the study and the participant flow up to and including randomisation. Methods/Design ALIFE@Work is a controlled trial, with randomisation to three arms: a control group, a phone based intervention group and an internet based intervention group. The intervention takes six months and is based on a cognitive behavioural approach, addressing physical activity and diet. It consists of 10 lessons with feedback from a personal counsellor, either by phone or e-mail, between each lesson. Lessons contain educational content combined with behaviour change strategies. Assignments in each lesson teach the participant to apply these strategies to every day life. The study population consists of employees from seven Dutch companies. The most important inclusion criteria are having a body mass index (BMI ≥ 25 kg/m2 and being an employed adult. Primary outcomes of the study are body weight and BMI, diet and physical activity. Other outcomes are: perceived health; empowerment; stage of change and self-efficacy concerning weight control, physical activity and eating habits; work performance/productivity; waist circumference, sum of skin folds, blood pressure, total blood cholesterol level and aerobic fitness. A cost-utility- and a cost-effectiveness analysis will be performed as well. Physiological outcomes are measured at baseline and after six and 24 months. Other outcomes are measured by questionnaire at baseline and after six, 12, 18 and 24 months. Statistical analyses for short term (six month results are performed with

  5. Estimation de la survie des alevins de carpe (C. carpio au cours de leur premier mois d'existence

    Directory of Open Access Journals (Sweden)

    MOREAU J.

    1979-10-01

    Full Text Available Des observations réalisées sur deux stations piscicoles de Madagascar, dans des étangs ne recevant ni engrais ni nourriture, révèlent qu'au cours de leur premier mois les alevins de carpe (C. carpio subissent des mortalités voi-sines de 50 %. Ces dernières sont encore plus élevées en début et en fin de saison de reproduction. Au début, les fortes mortalités sont dues à la température trop basse et aux disponibilités alimentaires insuffisantes ; en fin de saison de reproduction, la température trop élevée et la mauvaise qualité des œufs sont sans doute en cause. Une fumure adéquate des étangs de grossissement des alevins et une alimentation correcte des géniteurs permettront peut-être de diminuer ces mortalités.

  6. The Impact of Massage Therapy on Function in Pain Populations—A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part II, Cancer Pain Populations

    Science.gov (United States)

    Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin; Buckenmaier, Chester; Buckenmaier, Pamela; Cambron, Jerrilyn; Deery, Christopher; Schwartz, Jan; Werner, Ruth; Whitridge, Pete

    2016-01-01

    Abstract Purpose Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of massage therapy research and evidence for its efficacy in treating pain, function-related and health-related quality of life in cancer populations. Methods Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using the SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A diverse steering committee interpreted the results to develop recommendations. Results Twelve high quality and four low quality studies were subsequently included in the review. Results demonstrate massage therapy is effective for treating pain compared to no treatment [standardized mean difference (SMD)  = −.20] and active (SMD = −0.55) comparators. Compared to active comparators, massage therapy was also found to be beneficial for treating fatigue (SMD = −1.06) and anxiety (SMD = −1.24). Conclusion Based on the evidence, weak recommendations are suggested for massage therapy, compared to an active comparator, for the treatment of pain, fatigue, and anxiety. No recommendations were suggested for massage therapy compared to no treatment or sham control based on the available literature to date. This review addresses massage therapy safety, research challenges, how to address identified research gaps, and necessary next steps for implementing massage therapy as a viable pain management option for cancer pain populations. PMID:27165967

  7. Combining PPI with qualitative research to engage 'harder-to-reach' populations: service user groups as co-applicants on a platform study for a trial.

    Science.gov (United States)

    Morgan, Heather; Thomson, Gill; Crossland, Nicola; Dykes, Fiona; Hoddinott, Pat

    2016-01-01

    It is recommended that research studies are carried out with or by patients and the public through their involvement from the beginning and in as many stages as possible (known as PPI). Some studies formally invite patients and the public to participate in interviews and focused group discussions to collect views about topics (known as qualitative research). In our study on financial incentives for giving up smoking in pregnancy and breastfeeding, we combined both PPI and qualitative research to include the views of women with a range of experiences of smoking and breastfeeding. We involved two mother and baby groups in disadvantaged areas of North East Scotland and North West England as research partners on our team. First, we asked members to comment on our research plans and documents, which is standard PPI. Second, we asked members to participate in voice recorded discussions, contributing to qualitative research data. These discussions revealed different views from those that we heard through research interviews. They allowed us to develop more relevant research tools and resources. Members also helped us to identify people outside the groups who we could interview. Combining involvement and participation helped us to include the views of a wide range of women from 'harder-to-reach' groups who don't usually take part in research. This was important because the research was intended for women who could benefit from incentives to stop smoking in pregnancy and breastfeed, often present in such groups. Positive continuing relationships and trust improved on involvement or participation alone. ᅟ. Patient and public involvement (PPI) in all research studies is recommended from the earliest point and in as many stages as possible. Qualitative research is also recommended in the early stages of designing complex intervention trials. Combining both together might enable inclusion of 'harder-to-reach' perspectives from the target population(s), particularly when the

  8. Population deworming every 6 months with albendazole in 1 million pre-school children in north India: DEVTA, a cluster-randomised trial

    Science.gov (United States)

    Awasthi, Shally; Peto, Richard; Read, Simon; Richards, Susan M; Pande, Vinod; Bundy, Donald; the DEVTA (Deworming and Enhanced Vitamin A) team

    2013-01-01

    Summary Background In north India many pre-school children are underweight, many have intestinal worms, and 2–3% die at ages 1·0–6·0 years. We used the state-wide Integrated Child Development Service (ICDS) infrastructure to help to assess any effects of regular deworming on mortality. Methods Participants in this cluster-randomised study were children in catchment areas of 8338 ICDS-staffed village child-care centres (under-5 population 1 million) in 72 administrative blocks. Groups of four neighbouring blocks were cluster-randomly allocated in Oxford between 6-monthly vitamin A (retinol capsule of 200 000 IU retinyl acetate in oil, to be cut and dripped into the child's mouth every 6 months), albendazole (400 mg tablet every 6 months), both, or neither (open control). Analyses of albendazole effects are by block (36 vs 36 clusters). The study spanned 5 calendar years, with 11 6-monthly mass-treatment days for all children then aged 6–72 months. Annually, one centre per block was randomly selected and visited by a study team 1–5 months after any trial deworming to sample faeces (for presence of worm eggs, reliably assessed only after mid-study), weigh children, and interview caregivers. Separately, all 8338 centres were visited every 6 months to monitor pre-school deaths (100 000 visits, 25 000 deaths at age 1·0–6·0 years [the primary outcome]). This trial is registered at ClinicalTrials.gov, NCT00222547. Findings Estimated compliance with 6-monthly albendazole was 86%. Among 2589 versus 2576 children surveyed during the second half of the study, nematode egg prevalence was 16% versus 36%, and most infection was light. After at least 2 years of treatment, weight at ages 3·0–6·0 years (standardised to age 4·0 years, 50% male) was 12·72 kg albendazole versus 12·68 kg control (difference 0·04 kg, 95% CI −0·14 to 0·21, p=0·66). Comparing the 36 albendazole-allocated versus 36 control blocks in analyses of the primary outcome, deaths

  9. A randomized controlled open trial of population-based disease and case management in a Medicare Plus Choice health maintenance organization.

    Science.gov (United States)

    Martin, David C; Berger, Marc L; Anstatt, David T; Wofford, Jonathan; Warfel, DeAnn; Turpin, Robin S; Cannuscio, Carolyn C; Teutsch, Steven M; Mansheim, Bernard J

    2004-10-01

    The object of this study was to examine the effect of population-based disease management and case management on resource use, self-reported health status, and member satisfaction with and retention in a Medicare Plus Choice health maintenance organization (HMO). Study design consisted of a prospective, randomized controlled open trial of 18 months' duration. Participants were 8504 Medicare beneficiaries aged 65 and older who had been continuously enrolled for at least 12 months in a network model Medicare Plus Choice HMO serving a contiguous nine-county metropolitan area. Members were care managed with an expert clinical information system and frequent telephone contact. Main outcomes included self-reported health status measured by the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), resource use measured by admission rates and bed-days per thousand per year, member satisfaction, and costs measured by paid claims. More favorable outcomes occurred in the intervention group for satisfaction with the health plan (P management and case management led to improved self-reported satisfaction and social function but not to a global net decrease in resource use or improved member retention.

  10. The Impact of Massage Therapy on Function in Pain Populations—A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part III, Surgical Pain Populations

    Science.gov (United States)

    Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin; Buckenmaier, Chester; Buckenmaier, Pamela; Cambron, Jerrilyn; Deery, Christopher; Schwartz, Jan; Werner, Ruth; Whitridge, Pete

    2016-01-01

    Abstract Objective Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of the evidence for massage therapy’s efficacy in treating pain, function-related, and health-related quality of life outcomes in surgical pain populations. Methods Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A professionally diverse steering committee interpreted the results to develop recommendations. Results Twelve high quality and four low quality studies were included in the review. Results indicate massage therapy is effective for treating pain [standardized mean difference (SMD) = −0.79] and anxiety (SMD = −0.57) compared to active comparators. Conclusion Based on the available evidence, weak recommendations are suggested for massage therapy, compared to active comparators for reducing pain intensity/severity and anxiety in patients undergoing surgical procedures. This review also discusses massage therapy safety, challenges within this research field, how to address identified research gaps, and next steps for future research. PMID:27165970

  11. Views on clinical trial recruitment, biospecimen collection, and cancer research: population science from landscapes of the Haudenosaunee (People of the Longhouse).

    Science.gov (United States)

    Haring, Rodney C; Henry, Whitney Ann; Hudson, Maui; Rodriguez, Elisa M; Taualii, Maile

    2018-02-01

    Biomedical research in culturally distinct communities is often a challenge. Potential barriers to participation occur because science is presented in a format that lacks cultural acknowledgement. Investigations may also fail to showcase beneficial relevance to the communities or include them in true partnership. The history of biomedical research within Native American societies has been complicated by these issues. Historical trauma among many Native groups sometimes transcends into contemporary challenges in both recruitment to and participation particularly in biobanking research. The participants for this study included members of the Haudenosaunee, the People of the Longhouse. Native Americans, including the Haudenosaunee, endure some of the worst health disparities in the country. These include high rates of cancer, obesity, and diabetes which may be linked at least partially to genetic predisposition. Results from a Haudenosaunee urban population shared response on ways to improve recruitment strategies for biospecimen, cancer, and other health-related clinical trials. Mixed methods approaches were used, and community responses indicated the importance of creating trust through respectful partnership; promoting culturally appropriate recruitment materials; the need for a greater understanding of consenting and signature processes; the necessity for concise summary sheets; and a desire to have information that community member understand. Discussion items also include international Indigenous perspectives to biobanking and genetic-related health disparity research.

  12. Phonologie et morphosyntaxe de l’anglais dans un produit SIC : le premier module de MACAO Phonologie et morphosyntaxe de l’anglais dans un produit SIC : le premier module de MACAO

    Directory of Open Access Journals (Sweden)

    Laurence Vincent-Durroux

    2002-12-01

    Full Text Available La préoccupation fréquente, chez les étudiants spécialistes d’autres disciplines que l’anglais, d’améliorer leur compréhension de l’anglais oral a motivé notre démarche de création d’un produit SIC (Systèmes d’Information et de Communication : MACAO (Modules d’Aide à la Compréhension de l’Anglais Oral. Le premier module, "S’entraîner à la reconnaissance", est réalisé et l’outil informatique s’est révélé particulièrement utile pour notre projet. Dans cet article, nous faisons état des difficultés récurrentes en compréhension de l’anglais oral : elles peuvent être dues à des attentes erronées fondées sur la dissymétrie entre la langue écrite et la langue orale, mais aussi à une reconnaissance difficile de certains morphèmes par l’existence de variantes phonologiques en fonction du contexte et par la proximité phonologique de certains morphèmes. Nous présentons également comment le contenu du premier module tente d’apporter des solutions à ces difficultés : en amenant les apprenants à prendre conscience du phénomène de réduction vocalique et d’inaccentuation qui touche certaines syllabes des mots aussi bien que certains éléments monosyllabiques de l’énoncé et en proposant un entraînement à la reconnaissance de ces éléments. Le module est en cours de validation avec une phase d’évaluation.French students who have English as part of their curriculum often express the wish to improve their comprehension of oral English. This led us to envisage the creation of a CALL product: MACAO (Modules to help in the comprehension of oral English. The first module has been created: "Training oneself for recognition". The computer was particularly adequate in this prospect. In this paper we present the most frequent difficulties in the comprehension of oral English: they can be related either to erroneous expectations based on the dissymmetry between the written form and the oral

  13. Effect of a text messaging intervention on influenza vaccination in an urban, low-income pediatric and adolescent population: a randomized controlled trial.

    Science.gov (United States)

    Stockwell, Melissa S; Kharbanda, Elyse Olshen; Martinez, Raquel Andres; Vargas, Celibell Y; Vawdrey, David K; Camargo, Stewin

    2012-04-25

    Influenza infection results in substantial costs, morbidity, and mortality. Vaccination against influenza is particularly important in children and adolescents who are a significant source of transmission to other high-risk populations, yet pediatric and adolescent vaccine coverage remains low. Traditional vaccine reminders have had a limited effect on low-income populations; however, text messaging is a novel, scalable approach to promote influenza vaccination. To evaluate targeted text message reminders for low-income, urban parents to promote receipt of influenza vaccination among children and adolescents. Randomized controlled trial of 9213 children and adolescents aged 6 months to 18 years receiving care at 4 community-based clinics in the United States during the 2010-2011 influenza season. Of the 9213 children and adolescents, 7574 had not received influenza vaccine prior to the intervention start date and were included in the primary analysis. Parents of children assigned to the intervention received up to 5 weekly immunization registry-linked text messages providing educational information and instructions regarding Saturday clinics. Both the intervention and usual care groups received the usual care, an automated telephone reminder, and access to informational flyers posted at the study sites. Receipt of an influenza vaccine dose recorded in the immunization registry via an electronic health record by March 31, 2011. Receipt was secondarily assessed at an earlier fall review date prior to typical widespread influenza activity. Study children and adolescents were primarily minority, 88% were publicly insured, and 58% were from Spanish-speaking families. As of March 31, 2011, a higher proportion of children and adolescents in the intervention group (43.6%; n = 1653) compared with the usual care group (39.9%; n = 1509) had received influenza vaccine (difference, 3.7% [95% CI, 1.5%-5.9%]; relative rate ratio [RRR], 1.09 [95% CI, 1.04-1.15]; P = .001). At the

  14. Digital breast tomosynthesis plus synthesised images versus standard full-field digital mammography in population-based screening (TOSYMA): protocol of a randomised controlled trial.

    Science.gov (United States)

    Weigel, Stefanie; Gerss, Joachim; Hense, Hans-Werner; Krischke, Miriam; Sommer, Alexander; Czwoydzinski, Jörg; Lenzen, Horst; Kerschke, Laura; Spieker, Karin; Dickmaenken, Stefanie; Baier, Sonja; Urban, Marc; Hecht, Gerold; Heidinger, Oliver; Kieschke, Joachim; Heindel, Walter

    2018-05-14

    Development of digital breast tomosynthesis (DBT) provides a technology that generates three-dimensional data sets, thus reducing the pitfalls of overlapping breast tissue. Observational studies suggest that the combination of two-dimensional (2D) digital mammography and DBT increases diagnostic accuracy. However, because of duplicate exposure, this comes at the cost of an augmented radiation dose. This undesired adverse impact can be avoided by using synthesised 2D images reconstructed from the DBT data (s2D).We designed a diagnostic superiority trial on a high level of evidence with the aim of providing a comparison of screening efficacy parameters resulting from DBT+s2D versus the current screening standard 2D full-field digital mammography (FFDM) in a multicentre and multivendor setting on the basis of the quality-controlled, population-based, biennial mammography screening programme in Germany. 80 000 women in the eligible age 50-69 years attending the routine mammography screening programme and willing to participate in the TOSYMA trial will be assigned by 1:1 randomisation to either the intervention arm (DBT+s2D) or the control arm (FFDM) during a 12-month recruitment period in screening units of North Rhine-Westphalia and Lower Saxony. State cancer registries will provide the follow-up of interval cancers.Primary endpoints are the detection rate of invasive breast cancers at screening examination and the cumulative incidence of interval cancers in the 2 years after a negative examination. Secondary endpoints are the detection rate of ductal carcinoma in situ and of tumour size T1, the recall rate for assessment, the positive predictive value of recall and the cumulative 12-month incidence of interval cancers. An adaptive statistical design with one interim analysis provides the option to modify the design. This protocol has been approved by the local medical ethical committee (2016-132-f-S). Results will be submitted to international peer

  15. Remote population-based intervention for disruptive behavior at age four: study protocol for a randomized trial of Internet-assisted parent training (Strongest Families Finland-Canada).

    Science.gov (United States)

    McGrath, Patrick J; Sourander, Andre; Lingley-Pottie, Patricia; Ristkari, Terja; Cunningham, Charles; Huttunen, Jukka; Filbert, Katharine; Aromaa, Minna; Corkum, Penny; Hinkka-Yli-Salomäki, Susanna; Kinnunen, Malin; Lampi, Katja; Penttinen, Anne; Sinokki, Atte; Unruh, Anita; Vuorio, Jenni; Watters, Carolyn

    2013-10-21

    Oppositional Defiant Disorder (ODD) is characterized by angry and noncompliant behaviour. It is the most common disruptive behaviour disorder (DBD), with prevalence estimates of 6-9% for preschoolers and is closely linked to several long-term difficulties, including disorders of conduct, mood, anxiety, impulse-control, and substance abuse. ODD in children is related to parental depression, family dysfunction, and impairments in parental work performance. Children displaying early DBDs exhibit more symptoms of greater severity, more frequent offences, and commit more serious crimes later in life. The goal of the Strongest Families Finland Canada (SFFC) Smart Website intervention research program is to develop and evaluate an affordable, accessible, effective secondary prevention parent training program for disruptive behaviour in preschoolers to prevent the negative sequelae of ODD. Strongest Families is an 11-session program with two booster sessions that focuses on teaching skills to: strengthen parent-child relationships; reinforce positive behaviour; reduce conflict; manage daily transitions; plan for potentially problematic situations; promote emotional regulation and pro-social behaviour and decrease antisocial behaviour. This protocol paper describes an ongoing population-based randomized controlled trial (RCT) of high-risk 4 year-olds attending well-child clinics in Turku, Finland and environs to examine the effectiveness of the Strongest Families Smart Website intervention compared to an Education Control condition. Randomization consists of a 1:1 ratio for intervention versus the education group, stratified by the child's sex. The participants randomized to the intervention group receive access to the Strongest Families Smart Website and weekly telephone coaching sessions. The participants randomized to the Education Control condition receive access to a static website with parenting tips. Children are followed using parental and daycare teacher measures

  16. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS.

    Science.gov (United States)

    O'Neil, Patrick M; Garvey, W Timothy; Gonzalez-Campoy, J Michael; Mora, Pablo; Ortiz, Rafael Violante; Guerrero, German; Claudius, Birgitte; Pi-Sunyer, Xavier

    2016-11-01

    Scarce data exist on pharmacotherapy for obesity in Hispanic individuals. This post hoc analysis of pooled data from 4 phase 3a trials compared the efficacy and safety of liraglutide 3.0 mg versus placebo, as adjunct to a reduced-calorie diet and physical activity, in Hispanic versus non-Hispanic subgroups. We conducted the double-blind randomized, placebo-controlled trials in adults with a minimum body mass index (BMI) of 27 kg/m 2 with at least 1 comorbidity, or a minimum BMI of 30 kg/m 2 , at clinical research sites worldwide. In this analysis, we investigated possible differences in treatment effects between 534 Hispanics (10.4% of the population) and 4,597 non-Hispanics (89.6%) through statistical tests of interaction between subgroups and treatment. Variables examined included mean and categorical weight change, cardiovascular risk markers, and safety data. Both subgroups achieved clinically significant mean weight loss at end-of-treatment with liraglutide 3.0 mg versus placebo: Hispanics 7.0% versus 1.5%, treatment difference -5.1% (95% CI, -6.2 to -4.0); non-Hispanics 7.5% versus 2.3%, -5.2% (95% CI, -5.5 to -4.8). More individuals in both subgroups lost ≥5%, >10%, and >15% of their baseline weight with liraglutide 3.0 mg than with placebo. Efficacy endpoints generally did not vary with ethnicity (P>.05). Adverse events were comparable between ethnic subgroups, with more gastrointestinal disorders reported with liraglutide 3.0 mg than placebo. Efficacy and safety were largely similar between Hispanic and non-Hispanic subgroups. Results support that liraglutide 3.0 mg, used with a reduced-calorie diet and physical activity, can facilitate weight loss in Hispanic individuals. A1c = glycated hemoglobin BMI = body mass index CI = confidence interval FPG = fasting plasma glucose GLP-1 = glucagon-like peptide-1 hsCRP = high-sensitivity C-reactive protein SCALE = Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes T2DM

  17. Injury incidence in a Premier League youth soccer academy using the consensus statement: a prospective cohort study

    Science.gov (United States)

    Renshaw, Andrew

    2016-01-01

    Background There is an established risk of injury to young athletes exposed to high training loads. Identifying and monitoring injury risk is essential to aid prevention. The aim of this study was to use the consensus statement to determine the incidence and pattern of injury in 1 English Premier League soccer academy during 1 season. Methods A prospective cohort study included 181 elite academy soccer players during the 2012–2013 season. Players were divided into 5 age groups between 9 and 18 years. The number, type and incidence of injuries were recorded during matches and training. Incidence was calculated per 1000 hours of exposure. Results 127 injuries occurred during 29 346 hours of soccer exposure. 72% of injuries were non-contact related. Under (U)18 players sustained the highest number of match injuries. U12–14 players sustained the highest number of training injuries and injuries overall. U16 players sustained the highest number of severe injuries, and U18 players sustained the highest number of moderate injuries. U18 players sustained the highest number of injuries/1000 hours of training and overall. U15 players sustained the highest number of injuries/1000 hours of matches, the highest number of recurrent injuries and the highest incidence of recurrence. The most common injuries were muscle injuries in U15 and U18 players. The most common injury location was the anterior thigh, with the majority of these occurring in training. Conclusions Using the consensus statement, this study used a repeatable method to identify the injury profile of elite academy-level soccer players. PMID:27900186

  18. Le premier partenariat public-privé pour l’irrigation au Maroc : durable pour tous ?

    Directory of Open Access Journals (Sweden)

    Houdret Annabelle

    2016-03-01

    Full Text Available Les partenariats public-privé (PPP sont un phénomène relativement récent dans le secteur de l’irrigation ; le projet El Guerdane au Maroc est ainsi le premier de son genre. Inauguré en 2008, le projet alimente en eau 10 000 ha de plantations d’agrumes. Les banques internationales de développement le présentent comme un succès, mais l’impact sur le développement local est, au mieux, mitigé. Alors que certains agriculteurs ont bénéficié de cette initiative, d’autres ont été marginalisés, en termes d’accès à l’eau, aux terres fertiles et au développement. Fondé sur des recherches de terrain extensives conduites entre 2005 et 2013, l’article révèle trois problèmes cruciaux du projet PPP : des effets souvent négatifs sur les revenus des acteurs et sur le développement ; un partage inégal des coûts, des bénéfices et des risques entre les secteurs public et privé ; un impact environnemental incertain. Sur la base de ces résultats, l’étude situe le projet dans le contexte plus large de l’évolution des rapports de force politico-économiques au Maroc.

  19. The Effect of Promotional Tools on Conveying Brand Identity from Sport Consumers’ Viewpoint in the Country’s Premier League

    Directory of Open Access Journals (Sweden)

    Ehsan Asadollahi

    2017-10-01

    Full Text Available The economic environment and business, advertising in sport is one of the ways that most companies to manage the brand, its products and expanding its market in the country. The aim of the present study investigates the effects of advertising on transfer of brand identity from the perspective of sports consumers in Premier League football. This study on the nature and purpose and in terms of descriptive and correlational in terms of search data, a survey was carried out that way. After face and content validity, reliability test using Cronbach's alpha for the questionnaire, the effect of advertising tools 0.89, questionnaire transfer brand identity was 0.86, respectively. In order to analyze the data, descriptive and inferential statistical methods for the calculation and processing information, and also Spss software packages and LISREL were used. The study findings also confirmed the emergence of structural equation and the findings of other researchers, showed a promotional tool to transfer of brand identity from the perspective of the Sports consumer was significant effect (Chi-Square/df=2/04, RMSEA=0/059, P-Value =0/0001. The effect of each variable prioritize research also showed use of tool television advertising has the greatest impact on consumers transfer of brand identity. According to the results, it can be said that managers, marketers and planners of advertising companies, organizations and clubs and sporting goods service provider using of the effectiveness of each advertising tool and provide an integrated program of tools and to inform, remind and convince consumers can transfer of brand identity or brand and achieve their advertising goals.

  20. Does daily vitamin D 800 IU and calcium 1000 mg supplementation decrease the risk of falling in ambulatory women aged 65-71 years? A 3-year randomized population-based trial (OSTPRE-FPS).

    Science.gov (United States)

    Kärkkäinen, Matti K; Tuppurainen, Marjo; Salovaara, Kari; Sandini, Lorenzo; Rikkonen, Toni; Sirola, Joonas; Honkanen, Risto; Arokoski, Jari; Alhava, Esko; Kröger, Heikki

    2010-04-01

    The hypothesis was that the calcium and vitamin D supplementation prevents falls at the population level. The OSTPRE-FPS was a randomized population-based open-trial with 3-year follow-up. The supplementation group (n=1566) received daily cholecalciferol 800IU+calcium carbonate 1000mg, while the control group (n=1573) received no supplementation or placebo. A randomly selected subsample of 593 subjects underwent a detailed measurement program including serum 25(OH)D measurements. The occurrence of falls was the primary outcome of the study. The participants in the subsample were telephoned at 4 months intervals and the rest of the trial population was interviewed by phone once a year. In the entire trial population (ETP), there were 812 women with 1832 falls in the intervention group and 833 women with 1944 falls in the control group (risk ratio was 0.98, 95% CI 0.92-1.05, P=0.160). The supplementation was not associated with single or multiple falls in the ETP. However, in the subsample, multiple fall incidence decreased by 30% (odds ratio (OR) 0.70, 95% CI 0.50-0.97, P=0.034) in the supplementation group. Further, the supplementation decreased the incidence of multiple falls requiring medical attention (OR 0.72, 95% CI 0.53-0.97, P=0.031) in the ETP. The mean compliance in the entire trial population was 78% and in the subsample 79%. Overall, the primary analysis showed no association between calcium and vitamin D supplementation and risk of falls. However, the results of a post hoc analysis suggested that there was a decreased risk of multiple falls requiring medical attention: this finding requires confirmation. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

  1. The Impact of Massage Therapy on Function in Pain Populations-A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part I, Patients Experiencing Pain in the General Population.

    Science.gov (United States)

    Crawford, Cindy; Boyd, Courtney; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Yang, EunMee; Zhang, Weimin

    2016-07-01

    Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of massage therapy research and evidence for its efficacy in treating pain, function-related and health-related quality of life outcomes across all pain populations. Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A diverse steering committee interpreted the results to develop recommendations. Sixty high quality and seven low quality studies were included in the review. Results demonstrate massage therapy effectively treats pain compared to sham [standardized mean difference (SMD) = -.44], no treatment (SMD = -1.14), and active (SMD = -0.26) comparators. Compared to active comparators, massage therapy was also beneficial for treating anxiety (SMD = -0.57) and health-related quality of life (SMD = 0.14). Based on the evidence, massage therapy, compared to no treatment, should be strongly recommended as a pain management option. Massage therapy is weakly recommended for reducing pain, compared to other sham or active comparators, and improving mood and health-related quality of life, compared to other active comparators. Massage therapy safety, research challenges, how to address identified research gaps, and necessary next steps for implementing massage therapy as a viable pain management option are discussed.

  2. Long-term mother and child mental health effects of a population-based infant sleep intervention: cluster-randomized, controlled trial.

    Science.gov (United States)

    Hiscock, Harriet; Bayer, Jordana K; Hampton, Anne; Ukoumunne, Obioha C; Wake, Melissa

    2008-09-01

    Maternal depression is an established risk for adverse child development. Two thirds of clinically significant depressive symptoms occur in mothers reporting an infant sleep problem. We aimed to determine the long-term effects of a behavioral intervention for infant sleep problems on maternal depression and parenting style, as well as on child mental health and sleep, when the children reached 2 years of age. We conducted a cluster-randomized trial in well-child centers across 6 government areas of Melbourne, Australia. Participants included 328 mothers reporting an infant sleep problem at 7 months, drawn from a population sample (N = 739) recruited at 4 months. We compared the usual well-child care (n = 154) versus a brief behavior-modification program designed to improve infant sleep (n = 174) delivered by well-child nurses at ages 8 to 10 months and measured maternal depression symptoms (Edinburgh Postnatal Depression Scale); parenting practices (Parent Behavior Checklist); child mental health (Child Behavior Checklist); and maternal report of a sleep problem (yes or no). At 2 years, mothers in the intervention group were less likely than control mothers to report clinical depression symptoms: 15.4% vs 26.4% (Edinburgh Postnatal Depression Scale community cut point) and 4.2% vs 13.2% (Edinburgh Postnatal Depression Scale clinical cut point). Neither parenting style nor child mental health differed markedly between the intervention and control groups. A total of 27.3% of children in the intervention group versus 32.6% of control children had a sleep problem. The sleep intervention in infancy resulted in sustained positive effects on maternal depression symptoms and found no evidence of longer-term adverse effects on either mothers' parenting practices or children's mental health. This intervention demonstrated the capacity of a functioning primary care system to deliver effective, universally offered secondary prevention.

  3. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

  4. RECORD-4 multicenter phase 2 trial of second-line everolimus in patients with metastatic renal cell carcinoma: Asian versus non-Asian population subanalysis.

    Science.gov (United States)

    Yang, Lin; Alyasova, Anna; Ye, Dingwei; Ridolfi, Antonia; Dezzani, Luca; Motzer, Robert J

    2018-02-17

    RECORD-4 assessed everolimus in patients with metastatic renal cell carcinoma (mRCC) who progressed after 1 prior anti-vascular endothelial growth factor (VEGF) or cytokine and reinforced the clinical benefit of second-line everolimus. Because of the high percentage of patients from China enrolled in RECORD-4 (41%) and some reported differences in responses to certain targeted agents between Chinese and Western patients, this subanalysis evaluated outcomes in Asian versus non-Asian patients. RECORD-4 enrolled patients with clear cell mRCC into 3 cohorts based on prior first-line therapy: sunitinib, other anti-VEGF (sorafenib, bevacizumab, pazopanib, other), or cytokines. Patients received everolimus 10 mg/d until progression of disease (RECIST, v1.0) or intolerance. Primary end point was progression-free survival per investigator review. Data cutoff was Sept 1, 2014. Among Asian (n = 55) versus non-Asian (n = 79) patients, 98% versus 84% had good/intermediate MSKCC prognosis; 73% versus 65% were men, and 85% versus 73% were < 65 years of age. All (100%) Asian patients were of Chinese ethnicity. Median duration of exposure was 5.5 mo for Asian and 6.0 mo for non-Asian patients. Among Asian versus non-Asian patients, median progression-free survival (months) was 7.4 versus 7.8 overall, 7.4 versus 4.0 with prior sunitinib, and 5.7 versus 9.2 with prior other anti-VEGFs. Clinical benefit rate was similar between populations: 74.5% (95% CI 61.0-85.3) for Asian patients and 74.7% (95% CI 63.6-83.8) for non-Asian patients. Most patients achieved stable disease as best overall response (Asian, 63.6%; non-Asian, 69.6%). Overall rate of grade 3/4 adverse events appeared similar for Asian (58%) and non-Asian patients (54%). This RECORD-4 subanalysis demonstrated comparable efficacy and adverse event profiles of second-line everolimus in Asian and non-Asian patients. Efficacy and safety outcomes by prior therapy should be interpreted with caution because of small

  5. Towards Improving our Understanding on the Retrievals of Key Parameters Characterising Land Surface Interactions from Space: Introduction & First Results from the PREMIER-EO Project

    Science.gov (United States)

    Ireland, Gareth; North, Matthew R.; Petropoulos, George P.; Srivastava, Prashant K.; Hodges, Crona

    2015-04-01

    Acquiring accurate information on the spatio-temporal variability of soil moisture content (SM) and evapotranspiration (ET) is of key importance to extend our understanding of the Earth system's physical processes, and is also required in a wide range of multi-disciplinary research studies and applications. The utility and applicability of Earth Observation (EO) technology provides an economically feasible solution to derive continuous spatio-temporal estimates of key parameters characterising land surface interactions, including ET as well as SM. Such information is of key value to practitioners, decision makers and scientists alike. The PREMIER-EO project recently funded by High Performance Computing Wales (HPCW) is a research initiative directed towards the development of a better understanding of EO technology's present ability to derive operational estimations of surface fluxes and SM. Moreover, the project aims at addressing knowledge gaps related to the operational estimation of such parameters, and thus contribute towards current ongoing global efforts towards enhancing the accuracy of those products. In this presentation we introduce the PREMIER-EO project, providing a detailed overview of the research aims and objectives for the 1 year duration of the project's implementation. Subsequently, we make available the initial results of the work carried out herein, in particular, related to an all-inclusive and robust evaluation of the accuracy of existing operational products of ET and SM from different ecosystems globally. The research outcomes of this project, once completed, will provide an important contribution towards addressing the knowledge gaps related to the operational estimation of ET and SM. This project results will also support efforts ongoing globally towards the operational development of related products using technologically advanced EO instruments which were launched recently or planned be launched in the next 1-2 years. Key Words: PREMIER

  6. A culturally adapted lifestyle intervention addressing a Middle Eastern immigrant population at risk of diabetes, the MEDIM (impact of Migration and Ethnicity on Diabetes In Malmö): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Saha, Sanjib; Leijon, Matti; Gerdtham, Ulf; Sundquist, Kristina; Sundquist, Jan; Arvidsson, Daniel; Bennet, Louise

    2013-09-03

    Studies have shown that lifestyle interventions are effective in preventing or delaying the onset of type 2 diabetes in high-risk patients. However, research on the effectiveness of lifestyle interventions in high-risk immigrant populations with different cultural and socioeconomic backgrounds is scarce. The aim was to design a culturally adapted lifestyle intervention for an immigrant population and to evaluate its effectiveness and cost-effectiveness. In this randomized controlled trial, 308 participants (born in Iraq, living in Malmö, Sweden and at high risk of type 2 diabetes) will be allocated to either a culturally adapted intervention or a control group. The intervention will consist of 10 group counseling sessions focusing on diet, physical activity and behavioral change over 6 months, and the offer of exercise sessions. Cultural adaptation includes gender-specific exercise sessions, and counseling by a health coach community member. The control group will receive the information about healthy lifestyle habits provided by the primary health care center. The primary outcome is change in fasting glucose level. Secondary outcomes are changes in body mass index, insulin sensitivity, physical activity, food habits and health-related quality of life. Measurements will be taken at baseline, after 3 and 6 months. Data will be analyzed by the intention-to-treat approach. The cost-effectiveness during the trial period and over the longer term will be assessed by simulation modeling from patient, health care and societal perspectives. This study will provide a basis to measure the effectiveness of a lifestyle intervention designed for immigrants from the Middle East in terms of improvement in glucose metabolism, and will also assess its cost-effectiveness. Results from this trial may help health care providers and policy makers to adapt and implement lifestyle interventions suitable for this population group that can be conducted in the community. ClinicalTrials

  7. La sodomie dans l’affaire Théophile de Viau : questions de genre et de sexualité dans la France du premier xviie siècle

    Directory of Open Access Journals (Sweden)

    Matthieu Dupas

    2010-04-01

    Full Text Available L’affaire Théophile est source de malentendus. Alors que l’historiographie du libertinage, en se concentrant sur le libertinage érudit a fini par oublier que la sodomie était un enjeu majeur du procès, les historiens de la répression homosexuelle abordent les relations sexuelles entre hommes dans une perspective essentialiste, gommant toute distinction entre sodomie au xviie siècle et homosexualité à l’époque contemporaine. Il s’agit donc la première partie de cet article de souligner que la sodomie est au cœur de l’affaire à la fois comme objet de représentation littéraire et comme pratique illicite. La seconde partie consiste dans une historicisation des discours ayant trait aux relations sexuelles entre hommes, qui montre qu’on ne saurait confondre « homosexualité masculine » et « sodomie ». Celle-ci désigne en effet des rapports anaux aussi bien entre hommes et femmes qu’entre hommes seuls ; lorsque la notion est mobilisée pour renvoyer à des relations anales entre hommes, elle ne constitue pas pour autant une orientation sexuelle ; en tant que concept issu de la théologie, elle ne relève pas de la sexualité ; aucune déviation de genre ne lui est associée. Dans une troisième partie, il s’agit de montrer que la notion de sodomie ne doit pas nous conduire à ignorer les autres discours pouvant porter sur les relations sexuelles entre hommes dans la France du premier xviie siècle et qu’à ce titre, on ne saurait se suffire de cette catégorie pour aborder la question. Bref, cet article a pour but de poser les premiers jalons d’une histoire de l’homosexualité masculine dans la France du xviie siècle d’un point de vue historiciste, sinon constructionniste.Sodomy in the Theophile de Viau affair: questions of gender and sexuality in early modern France.There is a puzzling misunderstanding about the Theophile affair. While the historiography of libertinism, focusing on erudite

  8. Management Options for Women at Risk for Inherited Breast Cancer in a Multi-ethnic Health Plan Population: A Randomized Control Trial

    National Research Council Canada - National Science Library

    Schaefer, Catherine

    1998-01-01

    ...-to-moderate risk women from minority populations. Resulting strategies will be usefully applied in the large, ethnically and economically diverse populations of health maintenance organizations from which increasing...

  9. Management Options for Women at Risk for Inherited Breast Cancer in a Multi-ethnic Health Plan Population: A Randomized Control Trial

    National Research Council Canada - National Science Library

    Hiatt, Robert

    1997-01-01

    ...-to-moderate risk women from minority populations. Resulting stategies will be usefully applied in the large, ethnically and economically diverse populations of health maintenance organizations from which increasing...

  10. Clinical Trials

    Medline Plus

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

  11. Clinical Trials

    Medline Plus

    Full Text Available ... to-kol). This plan explains how the trial will work. The trial is led by a principal ... for the clinical trial. The protocol outlines what will be done during the clinical trial and why. ...

  12. Clinical Trials

    Medline Plus

    Full Text Available ... take part in a clinical trial. When researchers think that a trial's potential risks are greater than ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

  13. Clinical Trials

    Medline Plus

    Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are ... earlier than they would be in general medical practice. This is because late-phase trials have large ...

  14. Clinical Trials

    Medline Plus

    Full Text Available ... clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a ... will be done during the clinical trial and why. Each medical center that does the study uses ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ...

  16. Clinical Trials

    Medline Plus

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

  17. Real-world effects of medications for chronic obstructive pulmonary disease: protocol for a UK population-based non-interventional cohort study with validation against randomised trial results.

    Science.gov (United States)

    Wing, Kevin; Williamson, Elizabeth; Carpenter, James R; Wise, Lesley; Schneeweiss, Sebastian; Smeeth, Liam; Quint, Jennifer K; Douglas, Ian

    2018-03-25

    Chronic obstructive pulmonary disease (COPD) is a progressive disease affecting 3 million people in the UK, in which patients exhibit airflow obstruction that is not fully reversible. COPD treatment guidelines are largely informed by randomised controlled trial results, but it is unclear if these findings apply to large patient populations not studied in trials. Non-interventional studies could be used to study patient groups excluded from trials, but the use of these studies to estimate treatment effectiveness is in its infancy. In this study, we will use individual trial data to validate non-interventional methods for assessing COPD treatment effectiveness, before applying these methods to the analysis of treatment effectiveness within people excluded from, or under-represented in COPD trials. Using individual patient data from the landmark COPD Towards a Revolution in COPD Health (TORCH) trial and validated methods for detecting COPD and exacerbations in routinely collected primary care data, we will assemble a cohort in the UK Clinical Practice Research Datalink (selecting people between 1 January 2004 and 1 January 2017) with similar characteristics to TORCH participants and test whether non-interventional data can generate comparable results to trials, using cohort methodology with propensity score techniques to adjust for potential confounding. We will then use the methodological template we have developed to determine risks and benefits of COPD treatments in people excluded from TORCH. Outcomes are pneumonia, COPD exacerbation, mortality and time to treatment change. Groups to be studied include the elderly (>80 years), people with substantial comorbidity, people with and without underlying cardiovascular disease and people with mild COPD. Ethical approval has been granted by the London School of Hygiene & Tropical Medicine Ethics Committee (Ref: 11997). The study has been approved by the Independent Scientific Advisory Committee of the UK Medicines and

  18. Structurations formelle et conceptuelle des articles de dictionnaires : le premier modèle de codification des articles dans l’histoire des dictionnaires Larousse

    Directory of Open Access Journals (Sweden)

    Corbin Pierre

    2014-07-01

    Nous nous proposons d’examiner, dans l’histoire des dictionnaires généraux monolingues Larousse des origines à nos jours, une sélection de jalons de l’articulation entre structure conceptuelle et structure formelle des articles. Au regard de l’ampleur des données à couvrir, il ne pourra bien entendu s’agir que d’un survol, mais celui-ci permettra (1 de présenter le premier des trois modèles majeurs de codification des articles dans l’histoire des dictionnaires Larousse, celui qui trouve son origine dans le Nouveau dictionnaire de la langue française de 1856 ou ses éditions révisées, (2 de prendre en compte les dictionnaires proposés par cet éditeur en un siècle et demi qui ont repris le modèle de 1856 ou sa forme révisée, et (3 de présenter contrastivement au premier les deux autres modèles majeurs, qui trouvent leur ancrage chronologique respectivement dans le Grand dictionnaire universel du XIXe siècle de 1866-1876 et le Dictionnaire du français contemporain de 1966.

  19. Les premiers pas d’Agnon à Jaffa (1908-1912 First Steps of S.Y. Agnon in Jaffa (1908-1912 ראשית דרכו של עגנון ביפו (1908 עד 1912

    Directory of Open Access Journals (Sweden)

    Masha Itzhaki

    2012-11-01

    Full Text Available Les premiers pas du célèbre auteur S. Y. Agnon lors de son premier séjour à Jaffa (1908-1912 sont liés aux deux revues hébraïques : Ha-Omer, histoire d’un échec, et Ha-po‘el ha-tsa‘ir, histoire d’une réussite, et aux rédacteurs en chef de ces revues, les écrivains et pères spirituels du jeune Agnon, Sh. Ben Tzion, un écrivain esthétique, bourgeois, et Y. H. Brenner, un penseur tourmenté, un véritable intellectuel socialiste.The first period of the famous writer S. Y. Agnon in Jaffa (1908-1912 has a lot to do with two literary Hebrew periodicals: Ha-Omer, a story of a failure, and Ha-po‘el ha-tsa‘ir, a successful one, as well as  with two major figures in Hebrew literary milieu at that time, the editors, Sh. Ben Tzion and Y. H. Brenner.

  20. Clinical Trials

    Medline Plus

    Full Text Available ... Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial ... clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical trial's protocol describes what ...

  1. Children's Healthy Living (CHL) Program for remote underserved minority populations in the Pacific region: rationale and design of a community randomized trial to prevent early childhood obesity.

    Science.gov (United States)

    Wilken, Lynne R; Novotny, Rachel; Fialkowski, Marie K; Boushey, Carol J; Nigg, Claudio; Paulino, Yvette; Leon Guerrero, Rachael; Bersamin, Andrea; Vargo, Don; Kim, Jang; Deenik, Jonathan

    2013-10-09

    Although surveillance data are limited in the US Affiliated Pacific, Alaska, and Hawaii, existing data suggest that the prevalence of childhood obesity is similar to or in excess of other minority groups in the contiguous US. Strategies for addressing the childhood obesity epidemic in the region support the use of community-based, environmentally targeted interventions. The Children's Healthy Living Program is a partnership formed across institutions in the US Affiliated Pacific, Alaska, and Hawaii to design a community randomized environmental intervention trial and a prevalence survey to address childhood obesity in the region through affecting the food and physical activity environment. The Children's Healthy Living Program community randomized trial is an environmental intervention trial in four matched-pair communities in American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, and Hawaii and two matched-pair communities in Alaska. A cross-sectional sample of children (goal n = 180) in each of the intervention trial communities is being assessed for outcomes at baseline and at 24 months (18 months post-intervention). In addition to the collection of the participant-based measures of anthropometry, diet, physical activity, sleep and acanthosis nigricans, community assessments are also being conducted in intervention trial communities. The Freely Associated States of Micronesia (Federated States of Micronesia, and Republics of Marshall Islands and Palau) is only conducting elements of the Children's Healthy Living Program sampling framework and similar measurements to provide prevalence data. In addition, anthropometry information will be collected for two additional communities in each of the 5 intervention jurisdictions to be included in the prevalence survey. The effectiveness of the environmental intervention trial is being assessed based on the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. The Children

  2. Bridging the gap between the randomised clinical trial world and the real world by combination of population-based registry and electronic health record data: A case study in haemato-oncology.

    Science.gov (United States)

    Kibbelaar, R E; Oortgiesen, B E; van der Wal-Oost, A M; Boslooper, K; Coebergh, J W; Veeger, N J G M; Joosten, P; Storm, H; van Roon, E N; Hoogendoorn, M

    2017-11-01

    Randomised clinical trials (RCTs) are considered the basis of evidence-based medicine. It is recognised more and more that application of RCT results in daily practice of clinical decision-making is limited because the RCT world does not correspond with the clinical real world. Recent strategies aiming at substitution of RCT databases by improved population-based registries (PBRs) or by improved electronic health record (EHR) systems to provide significant data for clinical science are discussed. A novel approach exemplified by the HemoBase haemato-oncology project is presented. In this approach, a PBR is combined with an advanced EHR, providing high-quality data for observational studies and support of best practice development. This PBR + EHR approach opens a perspective on randomised registry trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. A comparative assessment of enamel mineral content and Streptococcus mutans population between conventional composites and composites containing nano amorphous calcium phosphate in fixed orthodontic patients: a split-mouth randomized clinical trial.

    Science.gov (United States)

    Jahanbin, Arezoo; Farzanegan, Fahimeh; Atai, Mohammad; Jamehdar, Saeed Amel; Golfakhrabadi, Parvaneh; Shafaee, Hooman

    2017-02-01

    The aim of this 'split-mouth design' trial was to evaluate the effect of the nano amorphous calcium phosphate (NACP) containing composite on enamel mineral contents and streptococcus mutans population in fixed orthodontic patients. Randomized, prospective, single-center controlled trial. Twenty-four patients between the ages of 13-18 years participated in this study. The control and test sides were randomly selected by a coin toss (1:1 ratio). On the control side orthodontic brackets were bonded on the buccal surfaces of upper premolars and laterals using an orthodontic composite (Transbond XT), and on the study side NACP-containing composite was used. Outcome measures were the mineral content around the brackets and S.mutans count. The later were calculated in the plaque around the brackets by real-time PCR at 3 months, and 6 months after the initiation of treatment. All stages of the study were blind using coding system. Paired t-test and repeated measurements were used for data analysis. In the third and sixth month, the bacterial population was significantly lower in the study side than the control side (P = 0.01 and 0.000).The mineral content of the study side was significantly higher than the controls, 6 months after brocket bonding (P = 0.004). There were no significant differences between the premolars and lateral teeth for all measurements. This research was performed in a single-center by one experienced clinician. NACP-containing composites have the potential to inhibit mineral content loss and S.mutans colonization around orthodontic brackets during fixed orthodontic treatments. This trial was not registered. The protocol was not published before trial commencement. © The Author 2016. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  4. Protocol for MInimizing the Risk of Metachronous Adenomas of the CoLorectum with Green Tea Extract (MIRACLE: a randomised controlled trial of green tea extract versus placebo for nutriprevention of metachronous colon adenomas in the elderly population

    Directory of Open Access Journals (Sweden)

    Brockmöller Jürgen

    2011-08-01

    Full Text Available Abstract Background Prevention of colorectal cancer is a major health care issue. People who have undergone colonoscopy screening and had colorectal polyps removed have a higher risk of being diagnosed with polyps again compared to the normal population. Therefore, it would be ideal to find appropriate means that effectively help to prevent the reoccurrence of polyps after polypectomy. So far, pharmaceutical chemoprevention with NSAIDs including aspirin has been shown to be effective but not gained general acceptance due to side effects. Nutraceuticals such as polyphenols from tea plants have demonstrated remarkable therapeutic and preventive effects in molecular, epidemiological and clinical trials. However, placebo-controlled trials demonstrating the efficacy of nutraceuticals for the (secondary prevention of colorectal polyps as precursors for colorectal cancer are missing. Methods/Design We present the design of a randomized, placebo controlled, multicentre trial to investigate the effect of diet supplementation with green tea extract containing 300 mg epigallocatechin gallate (EGCG, the major polyphenol in green tea, on the recurrence of colon adenomas. Patients who have undergone polypectomy for colonic polyps will be randomized to receive either green tea extract containing 150 mg EGCG two times daily or a placebo over the course of three years. After a one month run-in period in which all patients will receive the active intervention, 2534 patients will be randomized, and 2028 patients are expected to complete the whole study course. Incidence, number and histology of adenoma at endpoint colonoscopy at three years will be compared in both groups. Discussion The beneficial safety profile of decaffeinated green tea extract, the quantifiable and known active content EGCG, and the accumulating evidence of its cancer preventive potential require, in our view, a validation of this compound for the nutriprevention of colorectal adenoma. Good

  5. Computer tomography colonography participation and yield in patients under surveillance for 6-9 mm polyps in a population-based screening trial

    NARCIS (Netherlands)

    Tutein Nolthenius, Charlotte J.; Boellaard, Thierry N.; de Haan, Margriet C.; Nio, C. Yung; Thomeer, Maarten G. J.; Bipat, Shandra; Montauban van Swijndregt, Alexander D.; van de Vijver, Marc J.; Biermann, Katharina; Kuipers, Ernst J.; Dekker, Evelien; Stoker, Jaap

    2016-01-01

    Surveillance CT colonography (CTC) is a viable option for 6-9 mm polyps at CTC screening for colorectal cancer. We established participation and diagnostic yield of surveillance and determined overall yield of CTC screening. In an invitational CTC screening trial 82 of 982 participants harboured 6-9

  6. The Children and Parents in Focus project : a population-based cluster-randomised controlled trial to prevent behavioural and emotional problems in children.

    OpenAIRE

    Salari, Raziye; Fabian, Helena; Prinz, Ron; Lucas, Steven; Feldman, Inna; Fairchild, Amanda; Sarkadi, Anna

    2013-01-01

    BACKGROUND: There is large body of knowledge to support the importance of early interventions to improve child health and development. Nonetheless, it is important to identify cost-effective blends of preventive interventions with adequate coverage and feasible delivery modes. The aim of the Children and Parents in Focus trial is to compare two levels of parenting programme intensity and rate of exposure, with a control condition to address impact and cost-effectiveness of a universally offer...

  7. Experiences in running a complex electronic data capture system using mobile phones in a large-scale population trial in southern Nepal.

    Science.gov (United States)

    Style, Sarah; Beard, B James; Harris-Fry, Helen; Sengupta, Aman; Jha, Sonali; Shrestha, Bhim P; Rai, Anjana; Paudel, Vikas; Thondoo, Meelan; Pulkki-Brannstrom, Anni-Maria; Skordis-Worrall, Jolene; Manandhar, Dharma S; Costello, Anthony; Saville, Naomi M

    2017-01-01

    The increasing availability and capabilities of mobile phones make them a feasible means of data collection. Electronic Data Capture (EDC) systems have been used widely for public health monitoring and surveillance activities, but documentation of their use in complicated research studies requiring multiple systems is limited. This paper shares our experiences of designing and implementing a complex multi-component EDC system for a community-based four-armed cluster-Randomised Controlled Trial in the rural plains of Nepal, to help other researchers planning to use EDC for complex studies in low-income settings. We designed and implemented three interrelated mobile phone data collection systems to enrol and follow-up pregnant women (trial participants), and to support the implementation of trial interventions (women's groups, food and cash transfers). 720 field staff used basic phones to send simple coded text messages, 539 women's group facilitators used Android smartphones with Open Data Kit Collect, and 112 Interviewers, Coordinators and Supervisors used smartphones with CommCare. Barcoded photo ID cards encoded with participant information were generated for each enrolled woman. Automated systems were developed to download, recode and merge data for nearly real-time access by researchers. The systems were successfully rolled out and used by 1371 staff. A total of 25,089 pregnant women were enrolled, and 17,839 follow-up forms completed. Women's group facilitators recorded 5717 women's groups and the distribution of 14,647 food and 13,482 cash transfers. Using EDC sped up data collection and processing, although time needed for programming and set-up delayed the study inception. EDC using three interlinked mobile data management systems (FrontlineSMS, ODK and CommCare) was a feasible and effective method of data capture in a complex large-scale trial in the plains of Nepal. Despite challenges including prolonged set-up times, the systems met multiple data

  8. A multicentre randomised controlled trial of day hospital-based falls prevention programme for a screened population of community-dwelling older people at high risk of falls

    OpenAIRE

    Conroy, Simon; Kendrick, Denise; Harwood, Rowan; Gladman, John; Coupland, Carol; Sach, Tracey; Drummond, Avril; Youde, Jane; Edmans, Judi; Masud, Tahir

    2010-01-01

    Objective: to determine the clinical effectiveness of a day hospital-delivered multifactorial falls prevention programme, for community-dwelling older people at high risk of future falls identified through a screening process. Design: multicentre randomised controlled trial. Setting: eight general practices and three day hospitals based in the East Midlands, UK. Participants: three hundred and sixty-four participants, mean age 79 years, with a median of three falls risk factors per person at ...

  9. High acceptability of HIV pre-exposure prophylaxis but challenges in adherence and use: qualitative insights from a phase I trial of intermittent and daily PrEP in at-risk populations in Kenya.

    Science.gov (United States)

    Van der Elst, Elisabeth Maria; Mbogua, Judie; Operario, Don; Mutua, Gaudensia; Kuo, Caroline; Mugo, Peter; Kanungi, Jennifer; Singh, Sagri; Haberer, Jessica; Priddy, Frances; Sanders, Eduard Joachim

    2013-07-01

    This paper used qualitative methods to explore experiences of men who have sex with men and female sex workers in Nairobi and Mtwapa, Kenya, who used oral pre-exposure prophylaxis (PrEP) for HIV prevention as part of a four-month trial of safety, acceptability and adherence. Fifty-one of 72 volunteers who took part in a randomized, placebo-controlled, blinded trial that compared daily and intermittent dosage of PrEP underwent qualitative assessments after completing the trial. Analyses identified three themes: (i) acceptability of PrEP was high, i.e. side effects were experienced early in the study but diminished over time, however characteristics of pills could improve comfort and use; (ii) social impacts such as stigma, rumors, and relationship difficulties due to being perceived as HIV positive were prevalent; (iii) adherence was challenged by complexities of daily life, in particular post-coital dosing adherence suffered from alcohol use around time of sex, mobile populations, and transactional sex work. These themes resonated across dosing regimens and gender, and while most participants favored the intermittent dosing schedule, those in the intermittent group noted particular challenges in adhering to the post-coital dose. Culturally appropriate and consistent counseling addressing these issues may be critical for PrEP effectiveness.

  10. Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. Methods/Design This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18–64 years old with non-specific low back pain lasting ≥12 weeks and a self-reported average pain intensity of ≥4 on a 0–10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using

  11. A randomized clinical trial of hospital-based, comprehensive cardiac rehabilitation versus usual care for patients with congestive heart failure, ischemic heart disease, or high risk of ischemic heart disease (the DANREHAB trial) - design, intervention, and population

    DEFF Research Database (Denmark)

    Zwisler, A.D.O.; Schou, O.; Soja, A.M.B.

    2005-01-01

    , or readmissions due to heart disease based on linkage to public registries. The CR was an individually tailored, multidisciplinary program (6 weeks of intensive CR and 12 months of follow-up) including patient education, exercise training, dietary counseling, smoking cessation, psychosocial support, risk factor...... that a large-scale, centrally randomized clinical trial on comprehensive CR can be conducted among a broadly defined patient group, but reaching the stipulated number of 1800 patients was difficult. Although the study included relatively many women and older people, elderly patients and patients with high...

  12. A randomized clinical trial of hospital-based, comprehensive cardiac rehabilitation versus usual care for patients with congestive heart failure, ischemic heart disease, or high risk of ischemic heart disease (the DANREHAB trial)--design, intervention, and population

    DEFF Research Database (Denmark)

    Zwisler, Ann-Dorthe Olsen; Soja, Anne Merete Boas; Brønnum-Hansen, Henrik

    2005-01-01

    , or readmissions due to heart disease based on linkage to public registries. The CR was an individually tailored, multidisciplinary program (6 weeks of intensive CR and 12 months of follow-up) including patient education, exercise training, dietary counseling, smoking cessation, psychosocial support, risk factor...... that a large-scale, centrally randomized clinical trial on comprehensive CR can be conducted among a broadly defined patient group, but reaching the stipulated number of 1800 patients was difficult. Although the study included relatively many women and older people, elderly patients and patients with high...

  13. Internet-based brief personalized feedback intervention in a non-treatment-seeking population of adult heavy drinkers: a randomized controlled trial

    DEFF Research Database (Denmark)

    Hansen, Anders Blædel Gottlieb; Becker, Ulrik; Nielsen, Anette Søgaard

    2012-01-01

    Internet-based interventions for heavy drinkers show promising results, but existing research is characterized by few studies in nonstudent adult populations and few comparisons with appropriate control groups....

  14. Technical and tactical training team «Helios» Kharkiv in the first round of 23 Ukrainian football championship in the premier league 2013–2014

    Directory of Open Access Journals (Sweden)

    Rebaz Sleman

    2014-10-01

    Full Text Available Purpose: to define the characteristics of the model command of technical and tactical training team participating in the Ukrainian Premier League First League. Material and Methods: the research was conducted using the method of peer review. The experts were involved 5 specialists football. Results: the mean values for the analyzed variables in 10 games. The various technical and tactical actions and their percentage in the overall structure of the game team statistics for 20 games, as well as some indicators of team play "Helios" Kharkov. Conclusions: the obtained quantitative and qualitative indicators (coefficient of marriage as a team on the technical and tactical actions, as well as separately for each technical and tactical reception. The performances allow you to make adjustments to the training process this command to improve sportsmanship.

  15. Les premiers tours du monde à forfait. L’exemple de la Société des Voyages d’Etudes Autour du Monde (1878)

    OpenAIRE

    Gauthier, Lionel

    2012-01-01

    Dans la seconde moitié du XIXe siècle, avec le développement du bateau à vapeur et du chemin de fer, et l’ouverture de nouveaux axes de transport comme le Canal de Suez, le voyage autour du monde devient envisageable pour les touristes. Ainsi, dès 1872 des tours du monde à forfait sont organisés, ce qui témoigne de l’entrée du voyage autour du monde dans l’industrie touristique naissante. Cet article étudie ces premiers voyages d’un nouveau genre à travers l’exemple de la Société des Voyages ...

  16. Les premiers temps de l'architecture en briques au nord des Alpes : la question de l'origine cistercienne vue des Pays-Bas

    OpenAIRE

    Lehouck, Alexander

    2017-01-01

    L'argile est l'une des plus vieilles matières premières pour la fabrication de matériaux de construction. La chute de l'Empire romain a marqué la fin de l'utilisation de la brique au nord des Alpes. La brique ne ressurgit véritablement qu' à partir de la deuxième moitié du XIIe s. et de la première moitié du XIIe s.; dans la deuxième moitié du XIIIe s., la brique était devenue le matériau de construction le plus utilisé. Dans cet article, nous discutons les données concernant les premiers ...

  17. Le premier élément du patrimoine maritime de Saint-Pierre-et-Miquelon protégé au titre des monuments historiques

    Directory of Open Access Journals (Sweden)

    Herveline Delhumeau

    2009-05-01

    Full Text Available Ymac a été classé par arrêté du 14 février 2008 au titre des monuments historiques en raison de l’intérêt ethnologique lié à sa fonction de bateau-pilote. (fig. n° 1Figure 1Ymac, ex-Radar III. Photographie après 2003. © Yannick Lafourcade.Construit en 1965 à Mavilette (Nouvelle-Ecosse, Canada par le chantier Alfred Boudreau, ce bateau traditionnel de pêche à coque en bois avait été initialement armé pour la pêche aux poissons plats par Alex Doucet, d’où son premier nom Alex D. Après avoir p...

  18. See you at the match: Motivation for sport consumption and intrinsic psychological reward of premier football league spectators in South Africa

    Directory of Open Access Journals (Sweden)

    Frederick W. Stander

    2016-04-01

    Full Text Available Orientation: Local football contributes significantly to the social- and economic welfare of South Africa through its spectators. Understanding the motives and experiences of football spectators could provide opportunities for capitalising on football as revenue stream feeding the South African economy. Research purpose: To investigate how motives for sport consumption predict intrinsic psychological reward of South African premier league football spectators. Motivation for the study: Sport - particularly football - is an untapped resource for stimulating economic development and growth through its consumers. Spectators, who often experience their investment in the sport as deeply rewarding and meaningful, should participate more frequently in purchasing products or services associated with the sport. Through understanding the motives for sport consumption of South African premier league football spectators and the impact of these motives on intrinsic psychological reward experiences, football clubs are able to provide a targeted experience or service to spectators in order to further stimulate economic growth. Research design, approach and method: A census sample of 806 football spectators attending various matches at a football stadium in Soweto was drawn. A cross-sectional research design was implemented. This research was exploratory and descriptive. Structural equation modelling was implemented to assess the factor structures of the constructs, to confirm composite reliability of the measures and to assess the structural paths between the variables. Main findings: A predictive model for intrinsic psychological rewards (life satisfaction and meaning through the motivation for sport consumption (individual – and game related factors was confirmed. It was further established that motivation for sport consumption is significantly positively a related to and b associated with the experience of intrinsic psychological reward by South African

  19. Clinical Trials

    Medline Plus

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

  20. Clinical Trials

    Medline Plus

    Full Text Available ... clinical trials are vital to the process of improving medical care. Many people volunteer because they want ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  2. Clinical Trials

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

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    Full Text Available ... Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance ...

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

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

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    Full Text Available ... you agree to take part in the trial. Talk with your doctor about specific trials you're ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

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    Full Text Available ... any clinical trial before you agree to take part in the trial. Talk with your doctor about specific trials you're interested in. For a list of questions to ask your doctor and the ...

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... study? How might this trial affect my daily life? Will I have to be in the hospital? ...

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... from a study at any time, for any reason. Also, during the trial, you have the right ...

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

  12. Detailed methods of two home-based vegetable gardening intervention trials to improve diet, physical activity, and quality of life in two different populations of cancer survivors.

    Science.gov (United States)

    Cases, Mallory G; Frugé, Andrew D; De Los Santos, Jennifer F; Locher, Julie L; Cantor, Alan B; Smith, Kerry P; Glover, Tony A; Cohen, Harvey J; Daniel, Michael; Morrow, Casey D; Moellering, Douglas R; Demark-Wahnefried, Wendy

    2016-09-01

    Cancer survivors suffer from long-term adverse effects that reduce health-related quality of life (QOL) and physical functioning, creating an urgent need to develop effective, durable, and disseminable interventions. Harvest for Health, a home-based vegetable gardening intervention, holds promise for these domains. This report describes the methods and recruitment experiences from two randomized controlled feasibility trials that employ a waitlist-controlled design. Delivered in partnership with Cooperative Extension Master Gardeners, this intervention provides one-on-one mentorship of cancer survivors in planning and maintaining three seasonal vegetable gardens over 12months. The primary aim is to determine intervention feasibility and acceptability; secondary aims are to explore effects on objective and subjective measures of diet, physical activity and function, and QOL and examine participant factors associated with potential effects. One trial is conducted exclusively among 82 female breast cancer survivors residing in the Birmingham, AL metropolitan area (BBCS); another broadly throughout Alabama among 46 older cancer survivors aged >60 (ASCS). Response rates were 32.6% (BBCS) and 52.3% (ASCS). Both trials exceeded 80% of their accrual target. Leading reasons for ineligibility were removal of >10 lymph nodes (lymphedema risk factor), lack of physician approval, and unwillingness to be randomized to the waitlist. To date, recruitment and implementation of Harvest for Health appears feasible. Although both studies encountered recruitment challenges, lessons learned can inform future larger-scale studies. Vegetable gardening interventions are of interest to cancer survivors and may provide opportunities to gain life skills leading to improvements in overall health and QOL. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Baseline prevalence of abdominal aortic aneurysm, peripheral arterial disease and hypertension in men aged 65-74 years from a population screening study (VIVA trial)

    DEFF Research Database (Denmark)

    Grøndal, N; Søgaard, R; Lindholt, J S

    2015-01-01

    (PAD) and possible hypertension (HT), and detection rates. METHODS: This observational study was based on the intervention arm of a screening trial in 25 083 Danish men aged 65-74 years. A combined screening programme for AAA, PAD and HT was offered at local hospitals. Participants with positive test...... results were offered secondary prophylaxis and/or referred to their general practitioner. The programme set-up included decentralized screening by three mobile teams at 14 venues. Diagnostic criteria were: aortic diameter at least 30 mm for AAA, ankle : brachial pressure index below 0·9 or above 1...

  14. Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Saper, Robert B; Sherman, Karen J; Delitto, Anthony; Herman, Patricia M; Stevans, Joel; Paris, Ruth; Keosaian, Julia E; Cerrada, Christian J; Lemaster, Chelsey M; Faulkner, Carol; Breuer, Maya; Weinberg, Janice

    2014-02-26

    Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting ≥ 12 weeks and a self-reported average pain intensity of ≥ 4 on a 0-10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic

  15. Community-based trial of annual versus biannual single-dose ivermectin plus albendazole against Wuchereria bancrofti infection in human and mosquito populations: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    de Souza, Dziedzom K; Ahorlu, Collins S; Adu-Amankwah, Susan; Otchere, Joseph; Mensah, Sedzro K; Larbi, Irene A; Mensah, George E; Biritwum, Nana-Kwadwo; Boakye, Daniel A

    2017-10-02

    The Global Programme for the Elimination of Lymphatic Filariasis (GPELF) has been in operation since the year 2000, with the aim of eliminating the disease by the year 2020, following five to six rounds of effective annual mass drug administration (MDA). The treatment regimen is ivermectin (IVM) in combination with diethylcarbamazine (DEC) or albendazole (ALB). In Ghana, MDA has been undertaken since 2001. While the disease has been eliminated in many areas, transmission has persisted in some implementation units that had experienced 15 or more rounds of MDA. Thus, new intervention strategies could eliminate residual infection in areas of persistent transmission and speed up the lymphatic filariasis (LF)-elimination process. This study, therefore, seeks to test the hypothesis that biannual treatment of LF-endemic communities will accelerate the interruption of LF in areas of persistent transmission. A cluster randomised trial will be implemented in LF-endemic communities in Ghana. The interventions will be yearly or twice-yearly MDA delivered to entire endemic communities. Allocation to study group will be by clusters identified using the prevalence of LF. Clusters will be randomised to one of two groups: receiving either (1) annual treatment with IVM + ALB or (2) annual MDA with IVM + ALB, followed by an additional MDA 6 months later. The primary outcome measure is the prevalence of LF infection, assessed by four cross-sectional surveys. Entomological assessments will also be undertaken to evaluate the transmission intensity of the disease in the study clusters. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, microfilaria prevalence will be assessed longitudinally. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system. It is expected that this study will add to

  16. "FIND Technology": investigating the feasibility, efficacy and safety of controller-free interactive digital rehabilitation technology in an inpatient stroke population: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Bird, M L; Cannell, J; Callisaya, M L; Moles, E; Rathjen, A; Lane, K; Tyson, A; Smith, S

    2016-04-16

    Stroke results in significant disability, which can be reduced by physical rehabilitation. High levels of repetition and activity are required in rehabilitation, but patients are typically sedentary. Using clinically relevant and fun computer games may be one way to achieve increased activity in rehabilitation. A single-blind randomized controlled trial will be conducted to evaluate the feasibility, efficacy and safety of novel stroke-specific rehabilitation software. This software uses controller-free client interaction and inertial motion sensors. Elements of feasibility include recruitment into the trial, ongoing participation (adherence and dropout), perceived benefit, enjoyment and ease of use of the games. Efficacy will be determined by measuring activity and using upper-limb tasks as well as measures of balance and mobility. The hypothesis that the intervention group will have increased levels of physical activity within rehabilitation and improved physical outcomes compared with the control group will be tested. Results from this study will provide a basis for discussion of feasibility of this interactive video technological solution in an inpatient situation. Differences in activity levels between groups will be the primary measure of efficacy. It will also provide data on measures of upper-limb function, balance and mobility. ACTRN12614000427673 . Prospectively registered 17 April 2014.

  17. The Road Ahead to Cure Alzheimer’s Disease: Development of Biological Markers and Neuroimaging Methods for Prevention Trials Across all Stages and Target Populations

    Science.gov (United States)

    Cavedo, E.; Lista, S.; Khachaturian, Z.; Aisen, P.; Amouyel, P.; Herholz, K.; Jack, C.R.; Sperling, R.; Cummings, J.; Blennow, K.; O’Bryant, S.; Frisoni, G.B.; Khachaturian, A.; Kivipelto, M.; Klunk, W.; Broich, K.; Andrieu, S.; de Schotten, M. Thiebaut; Mangin, J.-F.; Lammertsma, A.A.; Johnson, K.; Teipel, S.; Drzezga, A.; Bokde, A.; Colliot, O.; Bakardjian, H.; Zetterberg, H.; Dubois, B.; Vellas, B.; Schneider, L.S.; Hampel, H.

    2015-01-01

    Alzheimer’s disease (AD) is a slowly progressing non-linear dynamic brain disease in which pathophysiological abnormalities, detectable in vivo by biological markers, precede overt clinical symptoms by many years to decades. Use of these biomarkers for the detection of early and preclinical AD has become of central importance following publication of two international expert working group’s revised criteria for the diagnosis of AD dementia, mild cognitive impairment (MCI) due to AD, prodromal AD and preclinical AD. As a consequence of matured research evidence six AD biomarkers are sufficiently validated and partly qualified to be incorporated into operationalized clinical diagnostic criteria and use in primary and secondary prevention trials. These biomarkers fall into two molecular categories: biomarkers of amyloid-beta (Aβ) deposition and plaque formation as well as of tau-protein related hyperphosphorylation and neurodegeneration. Three of the six gold-standard (“core feasible) biomarkers are neuroimaging measures and three are cerebrospinal fluid (CSF) analytes. CSF Aβ1-42 (Aβ1-42), also expressed as Aβ1-42 : Aβ1-40 ratio, T-tau, and P-tau Thr181 & Thr231 proteins have proven diagnostic accuracy and risk enhancement in prodromal MCI and AD dementia. Conversely, having all three biomarkers in the normal range rules out AD. Intermediate conditions require further patient follow-up. Magnetic resonance imaging (MRI) at increasing field strength and resolution allows detecting the evolution of distinct types of structural and functional abnormality pattern throughout early to late AD stages. Anatomical or volumetric MRI is the most widely used technique and provides local and global measures of atrophy. The revised diagnostic criteria for “prodromal AD” and “mild cognitive impairment due to AD” include hippocampal atrophy (as the fourth validated biomarker), which is considered an indicator of regional neuronal injury. Advanced image analysis

  18. Awareness and attitude towards human papillomavirus (HPV vaccine among medical students in a premier medical school in India.

    Directory of Open Access Journals (Sweden)

    Deeksha Pandey

    Full Text Available BACKGROUND: As preventing cancer with the help of a vaccine is a comparatively new concept, awareness and education about it will have important implication in the implementation of this strategy. MATERIALS AND METHODS: Present explorative questionnaire based survey included 618 MBBS students for final analysis. RESULTS: Majority of participants (89.6% were well aware of the preventable nature of cervical cancer. Most of them (89.2% knew that necessary factor responsible for cervical cancer is infection with high risk HPV. Awareness regarding the availability of vaccine against cervical cancer was 75.6%. Females had a better awareness regarding availability of vaccine, target population for vaccination and about the catch up program. Overall acceptance of HPV vaccine among the population studied was 67.8%. Medical teaching had a definitive impact on the understanding of this important public health issue. Females seemed to be more ready to accept the vaccine and recommend it to others. For our study population the most common source of information was medical school teaching. Majority of participants agreed that the most important obstacle in implementation of HPV vaccination program in our country is inadequate information and 86.2% wanted to be educated by experts in this regard. CONCLUSION: HPV vaccine for primary prevention of cervical cancer is a relatively new concept. Health professional will be able to play a pivotal role in popularizing this strategy.

  19. Brief Alcohol Intervention by Newly Trained Workers Versus Leaflets: Comparison of Effect in Older Heavy Drinkers Identified in a Population Health Examination Survey: A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Hansen, Anders Blædel Gottlieb; Becker, Ulrik; Nielsen, Anette Søgaard

    2011-01-01

    Aims: To test if a brief motivational intervention (BMI) in a non-treatment seeking population of heavy drinkers results in a reduced alcohol intake. Methods: Screening of 12,364 participants in a Danish health examination survey led to 1026 heavy drinkers of whom 772 were included and randomized...

  20. Effects of fertility education on knowledge, desires and anxiety among the reproductive-aged population: findings from a randomized controlled trial.

    Science.gov (United States)

    Maeda, E; Nakamura, F; Kobayashi, Y; Boivin, J; Sugimori, H; Murata, K; Saito, H

    2016-09-01

    What are the effects of fertility education on knowledge, childbearing desires and anxiety? Providing fertility information contributed to greater knowledge, but increased anxiety. Past studies have found that exposure to educational material improved fertility awareness and changed desires toward childbearing and its timing. Existing educational websites with evidence-based medical information provided in a non-judgmental manner have received favorable responses from reproductive-aged men and women. This three-armed (one intervention and two control groups), randomized controlled trial was conducted using online social research panels (SRPs) in Japan in January 2015. A total of 1455 participants (726 men and 729 women) between 20 and 39 years of age who hoped to have (more) children in the future were block-randomized and exposed to one of three information brochures: fertility education (intervention group), intake of folic acid during pregnancy (control group 1) or governmental financial support for pregnancy and childbirth (control group 2). Fertility knowledge was measured with the Japanese version of the Cardiff Fertility Knowledge Scale (CFKS-J). Knowledge, child-number and child-timing desires, subjective anxiety (i.e. whether participants felt anxiety [primary outcome]), and scores on the State-Trait Anxiety Inventory were assessed immediately after exposure. Non-inferiority comparisons were performed on subjective anxiety with non-inferiority declared if the upper limit of the two-sided 95% confidence interval (CI) for risk difference did not exceed a margin of 0.15. This test for non-inferiority was only performed for subjective anxiety; all the other variables were tests of superiority. Posttest scores on the CFKS-J (mean, SD) were higher in the intervention group than that of the control groups: intervention versus Control 1 and versus Control 2: 52.8 (28.8) versus 40.9 (26.2) (Pfertility may limit the generalizability of these findings. In addition to

  1. Blood pressure normalization in a large population of hypertensive patients treated with perindopril/indapamide combination: results of the OPTIMAX trial

    Directory of Open Access Journals (Sweden)

    Jean-Jacques Mourad

    2007-03-01

    Full Text Available Jean-Jacques Mourad1, Viet Nguyen1, Marilucy Lopez-Sublet1, Bernard Waeber21Dept Internal Medicine and Hypertension Unit, Avicenne hospital-APHP and Paris 13 University, Bobigny, France; 2Bernard Waeber, Division de Physiopathologie Clinique, Lausanne, SwitzerlandObjective: To determine if the fixed-dose perindopril/indapamide combination (Per/Ind normalizes blood pressure (BP in the same fraction of hypertensive patients when treated in everyday practice or in controlled trials.Methods: In this prospective trial, 17 938 hypertensive patients were treated with Per 2 mg/Ind 0.625 mg for 3–6 months. In Group 1 Per/Ind was initiated in newly diagnosed patients (n = 7032; in Group 2 Per/Ind replaced previous therapy in patients already treated but having either their BP still uncontrolled or experiencing side-effects (n = 7423; in Group 3 Per/Ind was added to previous treatment in patients with persistently high BP (n = 3483. BP was considered normalized when ≤ 140/90 mm Hg. A multivariate analysis for predictors of BP normalization was performed.Results: Subjects were on average 62 years old and had a baseline BP of 162.3/93.6 mm Hg. After treatment with Per/Ind, BP normalization was reached in 69.6% of patients in the Initiation group, 67.5% in the Replacement Group, and 67.4% in the Add-on Group (where patients were more frequently at risk, diabetic, or with target organ damage. Mean decreases in systolic BP of 22.8 mm Hg and in diastolic BP of 12.4 mm Hg were recorded. Conclusions: This trial was established to reflect everyday clinical practice, and a treatment strategy based on the Per/Ind combination, administered as initial, replacement, or add-on therapy, led to normalization rates that were superior to those observed in Europe in routine practice. These results support recent hypertension guidelines which encourage the use of combination therapy in the management of arterial hypertension.Keywords: perindopril, indapamide, blood

  2. Pulsed magnetic field versus ultrasound in the treatment of postnatal carpal tunnel syndrome: A randomized controlled trial in the women of an Egyptian population

    Directory of Open Access Journals (Sweden)

    Dalia M. Kamel

    2017-01-01

    Full Text Available The aim of this study was to compare the effects of pulsed electromagnetic field versus pulsed ultrasound in treating patients with postnatal carpal tunnel syndrome. The study was a randomized, double-blinded trial. Forty postnatal female patients with idiopathic carpal tunnel syndrome were divided randomly into two equal groups. One group received pulsed electromagnetic field, with nerve and tendon gliding exercises for the wrist, three times per week for four weeks. The other group received pulsed ultrasound and the same wrist exercises. Pain level, sensory and motor distal latencies and conduction velocities of the median nerve, functional status scale and hand grip strength were assessed pre- and post-treatment. There was a significant decrease (P  0.05. In conclusion, while the symptoms were alleviated in both groups, pulsed electromagnetic field was more effective than pulsed ultrasound in treating postnatal carpal tunnel syndrome.

  3. Clinical Trials

    Medline Plus

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

  4. Clinical Trials

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    Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key ... Enterprise NHLBI has a strong tradition of supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

  5. Clinical Trials

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

  6. A multi-center randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 1: Treatment efficiency.

    Science.gov (United States)

    O'Dywer, Lian; Littlewood, Simon J; Rahman, Shahla; Spencer, R James; Barber, Sophy K; Russell, Joanne S

    2016-01-01

    To use a two-arm parallel trial to compare treatment efficiency between a self-ligating and a conventional preadjusted edgewise appliance system. A prospective multi-center randomized controlled clinical trial was conducted in three hospital orthodontic departments. Subjects were randomly allocated to receive treatment with either a self-ligating (3M SmartClip) or conventional (3M Victory) preadjusted edgewise appliance bracket system using a computer-generated random sequence concealed in opaque envelopes, with stratification for operator and center. Two operators followed a standardized protocol regarding bracket bonding procedure and archwire sequence. Efficiency of each ligation system was assessed by comparing the duration of treatment (months), total number of appointments (scheduled and emergency visits), and number of bracket bond failures. One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed treatment. The mean treatment time and number of visits were 25.12 months and 19.97 visits in the SmartClip group and 25.80 months and 20.37 visits in the Victory group. The overall bond failure rate was 6.6% for the SmartClip and 7.2% for Victory, with a similar debond distribution between the two appliances. No significant differences were found between the bracket systems in any of the outcome measures. No serious harm was observed from either bracket system. There was no clinically significant difference in treatment efficiency between treatment with a self-ligating bracket system and a conventional ligation system.

  7. A clinical review of treatment outcomes in glioblastoma multiforme - the validation in a non-trial population of the results of a randomised Phase III clinical trial: has a more radical approach improved survival?

    LENUS (Irish Health Repository)

    Rock, K

    2012-01-03

    Objective: Glioblastoma multiforme (GBM) accounts for up to 60% of all malignant primary brain tumours in adults, occurring in 2-3 cases per 100 000 in Europe and North America. In 2005, a Phase III clinical trial demonstrated a significant improvement in survival over 2, and subsequently, 5 years with the addition of concurrent and adjuvant temozolomide (TMZ) to radical radiotherapy (RT) (Stupp R, Hegi M, van den Bent M, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol 2009:10:459-66). The aim of this study was to investigate if the demonstrated improved survival in the literature translated to clinical practice.Methods: This was a retrospective study including all patients with histologically proven GBM diagnosed from 1999 to 2008 and treated with adjuvant RT at our institution. A total of 273 patients were identified. Statistical analysis was carried out using SPSS v18.Results: The median survival for the whole group (n = 273) over the 10-year period was 7.6 months (95% confidence interval 6.7-8.4 months). Overall, the cumulative probability of survival at 1 and 2 years was 31.5 and 9.4%, respectively. In total, 146 patients received radical RT. 103 patients were treated with radical RT and TMZ and 43 patients received radical RT alone. The median survival for patients receiving radical RT with TMZ was 13.4 months (95% CI 10.9-15.8 months) vs 8.8 months for radical RT alone (95% CI 6.9 - 10.7 months, p = 0.006). 2-year survival figures were 21.2 vs 4.7%, respectively. On multivariate analysis, independent predictors of survival included KPS, RT dose, TMZ and extent of surgery. The strongest predictors of poorer outcome based on the hazard ratio were palliative RT, followed by not receiving TMZ chemotherapy, then KPS <90 and a biopsy only surgical approach.Conclusion: This paper demonstrates

  8. A clinical review of treatment outcomes in glioblastoma multiforme - the validation in a non-trial population of the results of a randomised Phase III clinical trial: has a more radical approach improved survival?

    LENUS (Irish Health Repository)

    2012-02-01

    Objective: Glioblastoma multiforme (GBM) accounts for up to 60% of all malignant primary brain tumours in adults, occurring in 2-3 cases per 100 000 in Europe and North America. In 2005, a Phase III clinical trial demonstrated a significant improvement in survival over 2, and subsequently, 5 years with the addition of concurrent and adjuvant temozolomide (TMZ) to radical radiotherapy (RT) (Stupp R, Hegi M, van den Bent M, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol 2009:10:459-66). The aim of this study was to investigate if the demonstrated improved survival in the literature translated to clinical practice.Methods: This was a retrospective study including all patients with histologically proven GBM diagnosed from 1999 to 2008 and treated with adjuvant RT at our institution. A total of 273 patients were identified. Statistical analysis was carried out using SPSS v18.Results: The median survival for the whole group (n = 273) over the 10-year period was 7.6 months (95% confidence interval 6.7-8.4 months). Overall, the cumulative probability of survival at 1 and 2 years was 31.5 and 9.4%, respectively. In total, 146 patients received radical RT. 103 patients were treated with radical RT and TMZ and 43 patients received radical RT alone. The median survival for patients receiving radical RT with TMZ was 13.4 months (95% CI 10.9-15.8 months) vs 8.8 months for radical RT alone (95% CI 6.9 - 10.7 months, p = 0.006). 2-year survival figures were 21.2 vs 4.7%, respectively. On multivariate analysis, independent predictors of survival included KPS, RT dose, TMZ and extent of surgery. The strongest predictors of poorer outcome based on the hazard ratio were palliative RT, followed by not receiving TMZ chemotherapy, then KPS <90 and a biopsy only surgical approach.Conclusion: This paper demonstrates improved

  9. A web- and mobile phone-based intervention to prevent obesity in 4-year-olds (MINISTOP): a population-based randomized controlled trial

    OpenAIRE

    Delisle, Christine; Sandin, Sven; Forsum, Elisabet; Henriksson, Hanna; Trolle-Lagerros, Ylva; Larsson, Christel; Maddison, Ralph; Ortega, Francisco B.; Ruiz, Jonatan R.; Silfvernagel, Kristin; Timpka, Toomas; Löf, Marie

    2015-01-01

    Background: Childhood obesity is an increasing health problem globally. Overweight and obesity may be established as early as 2-5 years of age, highlighting the need for evidence-based effective prevention and treatment programs early in life. In adults, mobile phone based interventions for weight management (mHealth) have demonstrated positive effects on body mass, however, their use in child populations has yet to be examined. The aim of this paper is to report the study design and methodol...

  10. Study protocol: a double blind randomised control trial of high volume image guided injections in Achilles and patellar tendinopathy in a young active population

    OpenAIRE

    Barker-Davies, Robert M.; Nicol, Alastair; McCurdie, I.; Watson, James; Baker, Polly; Wheeler, Patrick; Fong, Daniel; Lewis, Mark; Bennett, Alexander N.

    2017-01-01

    Background Chronic tendinopathy is a significant problem particularly in active populations limiting sporting and occupational performance. The prevalence of patellar tendinopathy in some sports is near 50% and the incidence of lower limb tendinopathy is 1.4% p.a. in the UK Military. Management includes isometric, eccentric, heavy slow resistance exercises and extracorporeal shockwave therapy (ESWT). Often these treatments are inadequate yet there is no good evidence for injection therapies a...

  11. Protocol for Birmingham Atrial Fibrillation Treatment of the Aged study (BAFTA: a randomised controlled trial of warfarin versus aspirin for stroke prevention in the management of atrial fibrillation in an elderly primary care population [ISRCTN89345269

    Directory of Open Access Journals (Sweden)

    Fletcher Kate

    2003-08-01

    Full Text Available Abstract Background Atrial fibrillation (AF is an important independent risk factor for stroke. Randomised controlled trials have shown that this risk can be reduced substantially by treatment with warfarin or more modestly by treatment with aspirin. Existing trial data for the effectiveness of warfarin are drawn largely from studies in selected secondary care populations that under-represent the elderly. The Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA study will provide evidence of the risks and benefits of warfarin versus aspirin for the prevention of stroke for older people with AF in a primary care setting. Study design A randomised controlled trial where older patients with AF are randomised to receive adjusted dose warfarin or aspirin. Patients will be followed up at three months post-randomisation, then at six monthly intervals there after for an average of three years by their general practitioner. Patients will also receive an annual health questionnaire. 1240 patients will be recruited from over 200 practices in England. Patients must be aged 75 years or over and have AF. Patients will be excluded if they have a history of any of the following conditions: rheumatic heart disease; major non-traumatic haemorrhage; intra-cranial haemorrhage; oesophageal varices; active endoscopically proven peptic ulcer disease; allergic hypersensitivity to warfarin or aspirin; or terminal illness. Patients will also be excluded if the GP considers that there are clinical reasons to treat a patient with warfarin in preference to aspirin (or vice versa. The primary end-point is fatal or non-fatal disabling stroke (ischaemic or haemorrhagic or significant arterial embolism. Secondary outcomes include major extra-cranial haemorrhage, death (all cause, vascular, hospital admissions (all cause, vascular, cognition, quality of life, disability and compliance with study medication.

  12. Effects of poly-bioactive compounds on lipid profile and body weight in a moderately hypercholesterolemic population with low cardiovascular disease risk: a multicenter randomized trial.

    Directory of Open Access Journals (Sweden)

    Rosa Solà

    Full Text Available A dietary supplement (AP, Armolipid Plus that combines red yeast rice extract, policosanol, berberine, folic acid, coenzyme Q10 and asthaxantine can have beneficial effects on cardiovascular disease (CVD biomarkers. The aim of this study was to assess whether the intake of AP, in combination with dietary recommendations, reduces serum low density lipoprotein cholesterol (LDL-c concentrations and other CVD biomarkers in patients with hypercholesterolemia. Eligible patients were recruited from the outpatient clinics of six Spanish hospitals Hospital Virgen del Rocío (Sevilla; Hospital San Jorge (Huesca; Hospital San Pedro (Logroño; Hospital Gregorio Marañón (Madrid, Hospital la Fe (Valencia and Hospital Universitari Sant Joan (Reus as recruiting and coordinating center. 102 participants (mean age ± SD; 50.91 ± 11.61; 32 men with low CVD, with mild-to-moderately elevated LDL-c (between 3.35 mmol/L and 4.88 mmol/L without hypolipemic therapy were randomized in a double-blind, parallel, controlled, multicenter trial commencing January 2012 and ending December 2012. Among the exclusion criteria were any concomitant chronic disease, triglycerides (TG >3.97 mmol/L, pregnant or lactating, and history of CVD. At 12 weeks, compared to placebo, AP reduced LDL-c by -6.9%, apolipoprotein (Apo B-100 by -6.6% and total cholesterol/HDL-c ratio by -5.5%, the ApoB/ApoA1 ratio by -8.6%, while increasing ApoA1 by +2.5% (p<0.05. AP consumption was associated with modest mean weight loss of -0.93 kg (95%CI: -1.74 to -0.12; P = 0.02 compared with control group while dietary composition remained unchanged in the AP group. The AP product was well tolerated. In conclusion, AP, combined with dietary recommendations, reduced LDL-c levels as well as total cholesterol/HDL-c and ApoB/ApoA1 ratios, while increasing Apo A1, all of which are improvements in CVD risk indicators. AP is a product which could benefit patients having moderate hyperlipidemia and excess body

  13. Effect of calcium and vitamin D supplementation on bone mineral density in women aged 65-71 years: a 3-year randomized population-based trial (OSTPRE-FPS).

    Science.gov (United States)

    Kärkkäinen, M; Tuppurainen, M; Salovaara, K; Sandini, L; Rikkonen, T; Sirola, J; Honkanen, R; Jurvelin, J; Alhava, E; Kröger, H

    2010-12-01

    The Osteoporosis Risk Factor and Prevention-Fracture Prevention Study (OSTPRE-FPS) was a randomized population-based open trial (n = 593). The supplementation group (n = 287) received daily cholecalciferol 800 IU + calcium 1,000 mg for 3 years while the control group (n = 306) received neither supplementation nor placebo. Daily vitamin D and calcium supplementation have a positive effect on the skeleton in ambulatory postmenopausal women. vitamin D deficiency is common in the elderly, and vitamin D levels are associated with low bone mineral density (BMD). The working hypothesis was that vitamin D and calcium supplementation could prevent bone loss in ambulatory postmenopausal women. the OSTPRE-FPS was a randomized population-based open trial with a 3-year follow-up in 3,432 women (aged 66 to 71 years). A randomly selected subsample of 593 subjects underwent BMD measurements. The supplementation group (n = 287) received daily cholecalciferol 800 IU + calcium 1,000 mg for 3 years while the control group (n = 306) received neither supplementation nor placebo. in the intention-to-treat analysis, total body BMD (n = 362) increased significantly more in the intervention group than in the control group (0.84% vs. 0.19%, p = 0.011). The BMD change differences at the lumbar spine (p = 0.372), femoral neck (p = 0.188), trochanter (p = 0.085), and total proximal femur (p = 0.070) were statistically nonsignificant. Analyses in compliant women (≥ 80% of use) resulted in stronger and statistically significant effects at the total body and femoral regions. daily vitamin D and calcium supplementation have a positive effect on the skeleton in ambulatory postmenopausal women with adequate nutritional calcium intake.

  14. Double-Blind Randomized Placebo Controlled Trial Demonstrating Serum Cholesterol Lowering Efficacy of a Smoothie Drink with Added Plant Stanol Esters in an Indonesian Population

    Directory of Open Access Journals (Sweden)

    Lanny Lestiani

    2018-01-01

    Full Text Available Indonesians have a high intake of saturated fats, a key contributing dietary factor to elevated blood cholesterol concentrations. We investigated the cholesterol lowering efficacy of a smoothie drink with 2 grams of plant stanols as esters to lower serum total and LDL-cholesterol concentrations in hypercholesterolemic Indonesian adults. The double-blind randomized placebo controlled parallel design study involved 99 subjects. Fifty subjects received control drink and dietary advice, and 49 subjects received intervention drink (Nutrive Benecol® and dietary advice. Baseline, midline (week 2, and endline (week 4 assessments were undertaken for clinical, anthropometric, and biochemical variables. Compared to control, the smoothie drink with plant stanols reduced serum LDL-cholesterol concentration by 7.6% (p<0.05 and 9.0% (p<0.05 in two and four weeks, respectively. Serum total cholesterol was reduced by 5.7% (p<0.05 compared to control in two weeks, and no further reduction was detected after four weeks (5.6%. Compared to baseline habitual diet, LDL-cholesterol was reduced by 9.3% (p<0.05 and 9.8% (p<0.05 in the plant stanol ester group in two and four weeks, respectively. We conclude that consumption of smoothie drink with added plant stanol esters effectively reduces serum total and LDL-cholesterol of hypercholesterolemic Indonesian subjects already in two weeks. Trial is registered as NCT02316808.

  15. A qualitative study of recruitment barriers, motivators, and community-based strategies for increasing clinical trials participation among rural and urban populations.

    Science.gov (United States)

    Friedman, Daniela B; Foster, Caroline; Bergeron, Caroline D; Tanner, Andrea; Kim, Sei-Hill

    2015-01-01

    Participation in clinical trials (CTs) is low among rural communities. Investigators report difficulty recruiting rural individuals for CTs. The study purpose was to identify recruitment barriers, motivators, and strategies to help increase access to and participation in CTs in rural and urban communities. Qualitative focus groups/interviews. Rural and urban counties in one southeastern state. Two hundred twelve African-American and white men and women ages 21+. Nineteen focus groups and nine interviews were conducted. Audio files were transcribed and organized into NVivo10. Recurring themes were examined by geographic location. Although similar barriers, motivators, and strategies were reported by urban and rural groups, perceptions regarding their importance varied. Recruitment barriers mentioned in both rural and urban groups included fear, side effects, limited understanding, limited time, and mistrust. Rural groups were more mindful of time commitment involved. Both rural and urban participants reported financial incentives as the top motivator to CT participation, followed by personal illness (urban groups) and benefits to family (rural groups). Recruitment strategies suggested by rural participants involved working with schools/churches and using word of mouth, whereas partnering with schools, word of mouth, and media were recommended most by urban groups. Perceived recruitment barriers, motivators, and strategies did not differ considerably between rural and urban groups. Major barriers identified by participants should be addressed in future CT recruitment and education efforts. Findings can inform recruitment and communication strategies for reaching both urban and rural communities.

  16. Factors predicting the development of pressure ulcers in an at-risk population who receive standardized preventive care: secondary analyses of a multicentre randomised controlled trial.

    Science.gov (United States)

    Demarre, Liesbet; Verhaeghe, Sofie; Van Hecke, Ann; Clays, Els; Grypdonck, Maria; Beeckman, Dimitri

    2015-02-01

    To identify predictive factors associated with the development of pressure ulcers in patients at risk who receive standardized preventive care. Numerous studies have examined factors that predict risk for pressure ulcer development. Only a few studies identified risk factors associated with pressure ulcer development in hospitalized patients receiving standardized preventive care. Secondary analyses of data collected in a multicentre randomized controlled trial. The sample consisted of 610 consecutive patients at risk for pressure ulcer development (Braden Score Pressure ulcers in category II-IV were significantly associated with non-blanchable erythema, urogenital disorders and higher body temperature. Predictive factors significantly associated with superficial pressure ulcers were admission to an internal medicine ward, incontinence-associated dermatitis, non-blanchable erythema and a lower Braden score. Superficial sacral pressure ulcers were significantly associated with incontinence-associated dermatitis. Despite the standardized preventive measures they received, hospitalized patients with non-blanchable erythema, urogenital disorders and a higher body temperature were at increased risk for developing pressure ulcers. Improved identification of at-risk patients can be achieved by taking into account specific predictive factors. Even if preventive measures are in place, continuous assessment and tailoring of interventions is necessary in all patients at risk. Daily skin observation can be used to continuously monitor the effectiveness of the intervention. © 2014 John Wiley & Sons Ltd.

  17. Bounce Back Now! Protocol of a population-based randomized controlled trial to examine the efficacy of a Web-based intervention with disaster-affected families.

    Science.gov (United States)

    Ruggiero, Kenneth J; Davidson, Tatiana M; McCauley, Jenna; Gros, Kirstin Stauffacher; Welsh, Kyleen; Price, Matthew; Resnick, Heidi S; Danielson, Carla Kmett; Soltis, Kathryn; Galea, Sandro; Kilpatrick, Dean G; Saunders, Benjamin E; Nissenboim, Josh; Muzzy, Wendy; Fleeman, Anna; Amstadter, Ananda B

    2015-01-01

    Disasters have far-reaching and potentially long-lasting effects on youth and families. Research has consistently shown a clear increase in the prevalence of several mental health disorders after disasters, including depression and posttraumatic stress disorder. Widely accessible evidence-based interventions are needed to address this unmet need for youth and families, who are underrepresented in disaster research. Rapid growth in Internet and Smartphone access, as well as several Web based evaluation studies with various adult populations has shown that Web-based interventions are likely to be feasible in this context and can improve clinical outcomes. Such interventions also are generally cost-effective, can be targeted or personalized, and can easily be integrated in a stepped care approach to screening and intervention delivery. This is a protocol paper that describes an innovative study design in which we evaluate a self-help Web-based resource, Bounce Back Now, with a population-based sample of disaster affected adolescents and families. The paper includes description and justification for sampling selection and procedures, selection of assessment measures and methods, design of the intervention, and statistical evaluation of critical outcomes. Unique features of this study design include the use of address-based sampling to recruit a population-based sample of disaster-affected adolescents and parents, telephone and Web-based assessments, and development and evaluation of a highly individualized Web intervention for adolescents. Challenges related to large-scale evaluation of technology-delivered interventions with high-risk samples in time-sensitive research are discussed, as well as implications for future research and practice. Published by Elsevier Inc.

  18. Trial of labour and vaginal birth after previous caesarean section: A population based study of Eastern African immigrants in Victoria, Australia.

    Science.gov (United States)

    Belihu, Fetene B; Small, Rhonda; Davey, Mary-Ann

    2017-03-01

    Variations in caesarean section (CS) between some immigrant groups and receiving country populations have been widely reported. Often, African immigrant women are at higher risk of CS than the receiving population in developed countries. However, evidence about subsequent mode of birth following CS for African women post-migration is lacking. The objective of this study was to examine differences in attempted and successful vaginal birth after previous caesarean (VBAC) for Eastern African immigrants (Eritrea, Ethiopia, Somalia and Sudan) compared with Australian-born women. A population-based observational study was conducted using the Victorian Perinatal Data Collection. Pearson's chi-square test and logistic regression analysis were performed to generate adjusted odds ratios for attempted and successful VBAC. Victoria, Australia. 554 Eastern African immigrants and 24,587 Australian-born eligible women with previous CS having singleton births in public care. 41.5% of Eastern African immigrant women and 26.1% Australian-born women attempted a VBAC with 50.9% of Eastern African immigrants and 60.5% of Australian-born women being successful. After adjusting for maternal demographic characteristics and available clinical confounding factors, Eastern African immigrants were more likely to attempt (OR adj 1.94, 95% CI 1.57-2.47) but less likely to succeed (OR adj 0.54 95% CI 0.41-0.71) in having a VBAC. There are disparities in attempted and successful VBAC between Eastern African origin and Australian-born women. Unsuccessful VBAC attempt is more common among Eastern African immigrants, suggesting the need for improved strategies to select and support potential candidates for vaginal birth among these immigrants to enhance success and reduce potential complications associated with failed VBAC attempt. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

  19. The effect of active video games on cognitive functioning in clinical and non-clinical populations: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Stanmore, Emma; Stubbs, Brendon; Vancampfort, Davy; de Bruin, Eling D; Firth, Joseph

    2017-07-01

    Physically-active video games ('exergames') have recently gained popularity for leisure and entertainment purposes. Using exergames to combine physical activity and cognitively-demanding tasks may offer a novel strategy to improve cognitive functioning. Therefore, this systematic review and meta-analysis was performed to establish effects of exergames on overall cognition and specific cognitive domains in clinical and non-clinical populations. We identified 17 eligible RCTs with cognitive outcome data for 926 participants. Random-effects meta-analyses found exergames significantly improved global cognition (g=0.436, 95% CI=0.18-0.69, p=0.001). Significant effects still existed when excluding waitlist-only controlled studies, and when comparing to physical activity interventions. Furthermore, benefits of exergames where observed for both healthy older adults and clinical populations with conditions associated with neurocognitive impairments (all p<0.05). Domain-specific analyses found exergames improved executive functions, attentional processing and visuospatial skills. The findings present the first meta-analytic evidence for effects of exergames on cognition. Future research must establish which patient/treatment factors influence efficacy of exergames, and explore neurobiological mechanisms of action. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

  20. The effects of computer-based mindfulness training on Self-control and Mindfulness within Ambulatorily assessed network Systems across Health-related domains in a healthy student population (SMASH): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Rowland, Zarah; Wenzel, Mario; Kubiak, Thomas

    2016-12-01

    Self-control is an important ability in everyday life, showing associations with health-related outcomes. The aim of the Self-control and Mindfulness within Ambulatorily assessed network Systems across Health-related domains (SMASH) study is twofold: first, the effectiveness of a computer-based mindfulness training will be evaluated in a randomized controlled trial. Second, the SMASH study implements a novel network approach in order to investigate complex temporal interdependencies of self-control networks across several domains. The SMASH study is a two-armed, 6-week, non-blinded randomized controlled trial that combines seven weekly laboratory meetings and 40 days of electronic diary assessments with six prompts per day in a healthy undergraduate student population at the Johannes Gutenberg University Mainz, Germany. Participants will be randomly assigned to (1) receive a computer-based mindfulness intervention or (2) to a wait-list control condition. Primary outcomes are self-reported momentary mindfulness and self-control assessed via electronic diaries. Secondary outcomes are habitual mindfulness and habitual self-control. Further measures include self-reported behaviors in specific self-control domains: emotion regulation, alcohol consumption and eating behaviors. The effects of mindfulness training on primary and secondary outcomes are explored using three-level mixed models. Furthermore, networks will be computed with vector autoregressive mixed models to investigate the dynamics at participant and group level. This study was approved by the local ethics committee (reference code 2015_JGU_psychEK_011) and follows the standards laid down in the Declaration of Helsinki (2013). This randomized controlled trial combines an intensive Ambulatory Assessment of 40 consecutive days and seven laboratory meetings. By implementing a novel network approach, underlying processes of self-control within different health domains will be identified. These results will

  1. Home-Based Intervention Program to Reduce Food Insecurity in Elderly Populations Using a TV App: Study Protocol of the Randomized Controlled Trial Saúde.Come Senior.

    Science.gov (United States)

    Rodrigues, Ana Maria; Gregório, Maria João; Gein, Pierre; Eusébio, Mónica; Santos, Maria José; de Sousa, Rute Dinis; Coelho, Pedro S; Mendes, Jorge M; Graça, Pedro; Oliveira, Pedro; Branco, Jaime C; Canhão, Helena

    2017-03-13

    The limited or uncertain access to adequate food in elderly people includes not only economic restrictions but also inability of food utilization due to functional or cognitive impairment, health problems, and illiteracy. The aim of this work is to present the protocol of the randomized controlled trial Saúde.Come Senior, an educational and motivational television (TV)-based intervention to promote healthy lifestyles and decrease food insecurity in elderly people. A randomized controlled study will be conducted in subjects aged 60 years and older with food insecurity, identified at 17 primary care centers in the Lisboa e Vale do Tejo health region in Lisbon, Portugal. The primary outcome will be the changes in participants' food insecurity score (evaluated by the Household Food Insecurity Scale) at 3 months. Change in other outcomes will be assessed (dietary habits, nutritional status, physical activity, health status, and clinical outcomes). Subjects will be followed over 6 months; the intervention will last 3 months. Data collection will be performed at 3 different time points (baseline, end of intervention at 3 months, and follow-up at 6 months). The intervention is based on an interactive TV app with an educational and motivational program specifically developed for the elderly that has weekly themes and includes daily content in video format: (1) nutrition and diet tips for healthy eating, (2) healthy, easy to cook and low-cost recipes, and (3) physical exercise programs. Furthermore, brief reminders on health behaviors will also be broadcasted through the TV app. The total duration of the study will be 6 months. The intervention is considered to be effective and meaningful if 50% of the individuals in the experimental group have a decrease of 1 point in the food insecurity score, all the remaining being unchanged. We expect to include and randomize 282 (141 experimental and 141 control) elderly with food insecurity. We will recruit a total of 1,128 subjects

  2. The efficacy of interactive, motion capture-based rehabilitation on functional outcomes in an inpatient stroke population: a randomized controlled trial.

    Science.gov (United States)

    Cannell, John; Jovic, Emelyn; Rathjen, Amy; Lane, Kylie; Tyson, Anna M; Callisaya, Michele L; Smith, Stuart T; Ahuja, Kiran Dk; Bird, Marie-Louise

    2018-02-01

    To compare the efficacy of novel interactive, motion capture-rehabilitation software to usual care stroke rehabilitation on physical function. Randomized controlled clinical trial. Two subacute hospital rehabilitation units in Australia. In all, 73 people less than six months after stroke with reduced mobility and clinician determined capacity to improve. Both groups received functional retraining and individualized programs for up to an hour, on weekdays for 8-40 sessions (dose matched). For the intervention group, this individualized program used motivating virtual reality rehabilitation and novel gesture controlled interactive motion capture software. For usual care, the individualized program was delivered in a group class on one unit and by rehabilitation assistant 1:1 on the other. Primary outcome was standing balance (functional reach). Secondary outcomes were lateral reach, step test, sitting balance, arm function, and walking. Participants (mean 22 days post-stroke) attended mean 14 sessions. Both groups improved (mean (95% confidence interval)) on primary outcome functional reach (usual care 3.3 (0.6 to 5.9), intervention 4.1 (-3.0 to 5.0) cm) with no difference between groups ( P = 0.69) on this or any secondary measures. No differences between the rehabilitation units were seen except in lateral reach (less affected side) ( P = 0.04). No adverse events were recorded during therapy. Interactive, motion capture rehabilitation for inpatients post stroke produced functional improvements that were similar to those achieved by usual care stroke rehabilitation, safely delivered by either a physical therapist or a rehabilitation assistant.

  3. PONTIAC (NT-proBNP selected prevention of cardiac events in a population of diabetic patients without a history of cardiac disease): a prospective randomized controlled trial.

    Science.gov (United States)

    Huelsmann, Martin; Neuhold, Stephanie; Resl, Michael; Strunk, Guido; Brath, Helmut; Francesconi, Claudia; Adlbrecht, Christopher; Prager, Rudolf; Luger, Anton; Pacher, Richard; Clodi, Martin

    2013-10-08

    The study sought to assess the primary preventive effect of neurohumoral therapy in high-risk diabetic patients selected by N-terminal pro-B-type natriuretic peptide (NT-proBNP). Few clinical trials have successfully demonstrated the prevention of cardiac events in patients with diabetes. One reason for this might be an inaccurate selection of patients. NT-proBNP has not been assessed in this context. A total of 300 patients with type 2 diabetes, elevated NT-proBNP (>125 pg/ml) but free of cardiac disease were randomized. The "control" group was cared for at 4 diabetes care units; the "intensified" group was additionally treated at a cardiac outpatient clinic for the up-titration of renin-angiotensin system (RAS) antagonists and beta-blockers. The primary endpoint was hospitalization/death due to cardiac disease after 2 years. At baseline, the mean age of the patients was 67.5 ± 9 years, duration of diabetes was 15 ± 12 years, 37% were male, HbA1c was 7 ± 1.1%, blood pressure was 151 ± 22 mm Hg, heart rate was 72 ± 11 beats/min, median NT-proBNP was 265.5 pg/ml (interquartile range: 180.8 to 401.8 pg/ml). After 12 months there was a significant difference between the number of patients treated with a RAS antagonist/beta-blocker and the dosage reached between groups (p titration of RAS antagonists and beta-blockers to maximum tolerated dosages is an effective and safe intervention for the primary prevention of cardiac events for diabetic patients pre-selected using NT-proBNP. (Nt-proBNP Guided Primary Prevention of CV Events in Diabetic Patients [PONTIAC]; NCT00562952). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  4. Prediction of cardiovascular outcome by estimated glomerular filtration rate and estimated creatinine clearance in the high-risk hypertension population of the VALUE trial.

    Science.gov (United States)

    Ruilope, Luis M; Zanchetti, Alberto; Julius, Stevo; McInnes, Gordon T; Segura, Julian; Stolt, Pelle; Hua, Tsushung A; Weber, Michael A; Jamerson, Ken

    2007-07-01

    Reduced renal function is predictive of poor cardiovascular outcomes but the predictive value of different measures of renal function is uncertain. We compared the value of estimated creatinine clearance, using the Cockcroft-Gault formula, with that of estimated glomerular filtration rate (GFR), using the Modification of Diet in Renal Disease (MDRD) formula, as predictors of cardiovascular outcome in 15 245 high-risk hypertensive participants in the Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial. For the primary end-point, the three secondary end-points and for all-cause death, outcomes were compared for individuals with baseline estimated creatinine clearance and estimated GFR or = 60 ml/min using hazard ratios and 95% confidence intervals. Coronary heart disease, left ventricular hypertrophy, age, sex and treatment effects were included as covariates in the model. For each end-point considered, the risk in individuals with poor renal function at baseline was greater than in those with better renal function. Estimated creatinine clearance (Cockcroft-Gault) was significantly predictive only of all-cause death [hazard ratio = 1.223, 95% confidence interval (CI) = 1.076-1.390; P = 0.0021] whereas estimated GFR was predictive of all outcomes except stroke. Hazard ratios (95% CIs) for estimated GFR were: primary cardiac end-point, 1.497 (1.332-1.682), P cause death, 1.231 (1.098-1.380), P = 0.0004. These results indicate that estimated glomerular filtration rate calculated with the MDRD formula is more informative than estimated creatinine clearance (Cockcroft-Gault) in the prediction of cardiovascular outcomes.

  5. Neurodynamic mobilization and foam rolling improved delayed-onset muscle soreness in a healthy adult population: a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Blanca Romero-Moraleda

    2017-10-01

    Full Text Available Objectives Compare the immediate effects of a Neurodynamic Mobilization (NM treatment or foam roller (FR treatment after DOMS. Design Double blind randomised clinical trial. Setting The participants performed 100 drop jumps (5 sets of 20 repetitions, separated by 2 min rests from a 0.5-m high box in a University biomechanics laboratory to induce muscle soreness. The participants were randomly assigned in a counter-balanced fashion to either a FR or NM treatment group. Participants Thirty-two healthy subjects (21 males and 11 females, mean age 22.6 ± 2.2 years were randomly assigned into the NM group (n = 16 or the FR group (n = 16. Main Outcome Measures The numeric pain rating scale (NPRS; 0–10, isometric leg strength with dynamometry, surface electromyography at maximum voluntary isometric contraction (MVIC and muscle peak activation (MPA upon landing after a test jump were measured at baseline, 48 h after baseline before treatment, and immediately after treatment. Results Both groups showed significant reduction in NPRS scores after treatment (NM: 59%, p  .05. The percentage change improvement in the MVIC for the rectus femoris was the only significant difference between the groups (p < 0.05 at post-treatment. After treatment, only the FR group had a statistically significant improvement (p < 0.01 in strength compared to pre-treatment. Conclusion Our results illustrate that both treatments are effective in reducing pain perception after DOMS whereas only FR application showed differences for the MVIC in the rectus femoris and strength.

  6. A randomized trial of fish oil omega-3 fatty acids on arterial health, inflammation, and metabolic syndrome in a young healthy population

    Science.gov (United States)

    2013-01-01

    Background Long chain omega-3 fatty acids from fish oils (O3) are known to have beneficial effects on a number of vascular risk factors in at-risk populations. The effects of a highly bioavailable emulsified preparation on an overweight young adult population are less well known. Methods Young adults, age 18–30, with body mass indices (BMIs) greater than 23 (average = 28.1) were administered 1.7 g of O3 per day (N = 30) or safflower oil placebo (N = 27) in an emulsified preparation (Coromega, Inc.) for 4 weeks in a double-blind randomized design. Blood was drawn and anthropometric measurements taken before and after dosing. Hemodynamic measures (central pulse wave velocity, augmentation index, and aortic systolic blood pressure), inflammatory cytokines (IL-6, IL-8, IL-10, and tumor necrosis factor-α), red blood cell and plasma phospholipid fatty acid profiles, fasting serum lipids, glucose, and C-reactive protein were measured. Results Red cell and plasma phospholipid eicosapentaenoic acid and docosahexaenoic acid concentrations increased over the four weeks of dosing in the O3 group. Dosing with O3 did not affect central pulse wave velocity, augmentation index, or aortic systolic blood pressure. None of the five American Heart Association metabolic syndrome components improved over the dosing period. None of the inflammatory cytokines, C-reactive protein, or lipids (total or LDL cholesterol) improved over the dosing period. Conclusions No salutary effects of O3 were observed in hemodynamic, metabolic syndrome criteria or inflammatory markers as a result of this relatively short period of administration in this relatively overweight, but healthy young adult cohort. PMID:23565815

  7. Intake of low sodium salt substitute for 3years attenuates the increase in blood pressure in a rural population of North China - A randomized controlled trial.

    Science.gov (United States)

    Zhou, Bo; Webster, Jacqui; Fu, Ling-Yu; Wang, Hai-Long; Wu, Xiao-Mei; Wang, Wen-Li; Shi, Jing-Pu

    2016-07-15

    Lowering salt intake is one of the successful and cost-effective methods to reduce blood pressure (BP). In this randomized controlled study, we investigated the effects of a 3-year substitution of table salt with a low-sodium salt substitute in a rural population of North China. Subjects from 200 families residing in five villages in Liaoning, North China were registered in this study and randomly divided into two groups: normal salt (100% sodium chloride) and low salt substitute (65% NaCl, 25% KCl, 10% MgSO4). We compared the effects of the low-sodium salt substitute and normal salt on differences in BP from baseline to various follow-up time points during this 3-year study period. We also examined several factors that may affect the long-term changes in BP. Hypertension was defined per World Health Organization guidelines as BP≥140/90mmHg. The low sodium substitute significantly reduced the increase in both systolic and diastolic BP compared with the regular salt (P=0.000). Also, the population aged 40-70years showed most beneficial response to the salt substitute compared with those aged 70years. The low salt substitute had similar beneficial effects in both males and females. In addition, the salt type consumed and body mass index significantly affected the change in BP. Use of the salt substitute significantly reduces the increase in BP over a long term, and thus, the salt substitute can be used as a replacement for regular salt in the daily diet to prevent/diminish the incidence of hypertension. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  8. Efficacy of transcutaneous electrical nerve stimulation (tens) for chronic low-back pain in a multiple sclerosis population: a randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    Warke, Kim; Al-Smadi, Jamal; Baxter, David; Walsh, Deirdre M; Lowe-Strong, Andrea S

    2006-01-01

    This study was designed to investigate the hypoalgesic effects of self-applied transcutaneous electrical nerve stimulation (TENS) on chronic low-back pain (LBP) in a multiple sclerosis (MS) population. Ninety participants with probable or definite MS (aged 21 to 78 y) presenting with chronic LBP were recruited and randomized into 3 groups (n=30 per group): (1) low-frequency TENS group (4 Hz, 200 micros); (2) high-frequency TENS group (110 Hz, 200 micros); and (3) placebo TENS. Participants self-applied TENS for 45 minutes, a minimum of twice daily, for 6 weeks. Outcome measures were recorded at weeks 1, 6, 10, and 32. Primary outcome measures included: Visual Analog Scale for average LBP and the McGill Pain Questionnaire. Secondary outcome measures included: Visual Analog Scale for worst and weekly LBP, back and leg spasm; Roland Morris Disability Questionnaire; Barthel Index; Rivermead Mobility Index; Multiple Sclerosis Quality of Life-54 Instrument, and a daily logbook. Data were analyzed blind using parametric and nonparametric tests, as appropriate. Results indicated a statistically significant interactive effect between groups for average LBP (P=0.008); 1-way analysis of covariance did not show any significant effects at any time point once a Bonferonni correction was applied (P>0.05). However, clinically important differences were observed in some of the outcome measures in both active treatment groups during the treatment and follow-up periods. Although not statistically significant, the observed effects may have implications for the clinical prescription and the use of TENS within this population.

  9. Analysis of physical match performance in English Premier League soccer referees with particular reference to first half and player work rates.

    Science.gov (United States)

    Weston, Matthew; Castagna, Carlo; Impellizzeri, Franco M; Rampinini, Ermanno; Abt, Grant

    2007-12-01

    The aim of the present study was to examine the influence of first half activity, overall match intensity and seasonal variation on the physical match performances of English Premier League football referees. Match analysis data was collected using the Prozone match analysis system from 19 full-time professional referees during a total of 254 matches in the 2004-2005 season. Physical match performances were classified into three separate categories: 1, total distance covered (TD); 2, high-intensity running distance (running speed>5.5m/s, HIR); 3, average distance from infringements (DI). Using these match activity variables the influence of first half TD and HIR distances on second half activities and also the influence of players' match activities upon the referees' physical match performances were examined. The main finding of the present study was that the physical match performances of the referees were partly related to those of the players, in that the referees' HIR correlated with players' HIR (r=0.43, pphysical match performance of the referee. Further examination is required as to whether reduced physical performances in the second half of matches are a consequence of referee fatigue, tactical strategies on behalf of the referee or reduced player match activities resulting in a slower tempo of match.

  10. Management of chronic recurrent osteitis pubis/pubic bone stress in a Premier League footballer: Evaluating the evidence base and application of a nine-point management strategy.

    Science.gov (United States)

    McAleer, Stephen S; Gille, Justus; Bark, Stefan; Riepenhof, Helge

    2015-08-01

    The aim of this paper was to use a clinical example to describe a treatment strategy for the management of recurrent chronic groin pain and evaluate the evidence of the interventions. A professional footballer presented with chronic recurrent OP/PBS. The injury was managed successfully with a nine-point programme - 1. Acute pharmacological management. 2. Tone reduction of over-active structures. 3. Improved ROM at hips, pelvis and thorax. 4. Adductor strength. 5. Functional movement assessment. 6. Core stability. 7. Lumbo-pelvic control. 8. Gym-based strengthening. 9. Field-based conditioning/rehabilitation. The evidence for these interventions is reviewed. The player returned to full training and match play within 41 and 50 days, respectively, and experienced no recurrence of his symptoms in follow up at 13 months. This case report displays a nine-point conservative management strategy for OP/PBS, with non-time dependent clinical objective markers as the progression criteria in a Premier League football player. Copyright © 2015 Elsevier Ltd. All rights reserved.

  11. Clinical Trials

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

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

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

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    Full Text Available ... decisionmaking. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ... otherwise. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ...

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    Full Text Available ... identified earlier than they would be in general medical practice. This is because late-phase trials have large ... supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

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

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  19. From Raja to Prime Minister Entre rajah et premier ministre. Les étrangers et l’exploitation économique à Bornéo et dans le Pacifique au xixe siècle

    Directory of Open Access Journals (Sweden)

    Kees van Dijk

    2013-03-01

    Full Text Available Some twenty years after the Sultan of Brunei had bestowed upon the Englishman James Brooke the title of Rajah of Sarawak, giving him extensive authorities over a large tract of land, an American, Joseph William Torrey, United States consul in Brunei, gained the right to call himself Rajah of Marudu and Ambong. Though Torrey’s efforts failed to establish a profitable business in Sabah, they formed the root of the British North Borneo Company. Torrey probably was one of the last of his kind. Elsewhere in the Pacific, European and American residents and adventurers did not bother much about native titles, expanding their hold over land and its inhabitants by economic and political manipulation. In Hawaii and Samoa political reform and becoming cabinet minister or prime minister of a still independent island state served their purposes better.Quelque vingt ans après que le sultan de Brunei eut accordé à l’Anglais James Brooke le titre de rajah de Sarawak, qui lui donnait d’importants pouvoirs sur une vaste région, un Américain, Joseph William Torrey, consul des Etats-Unis à Brunei, obtint le titre de rajah de Marudu et Ambong. Les efforts de Torrey, échouant à établir une affaire profitable à Sabah, constituèrent néanmoins les bases de la British North Borneo Company. Torrey fut sans doute l’un des derniers de ce type d’aventuriers. Ailleurs dans le Pacifique, des résidents et des aventuriers européens et américains, par des manœuvres économiques et politiques, consolidèrent leur contrôle sur les territoires et leurs populations, sans trop se soucier d’obtenir des titres locaux. A Hawaii et à Samoa, il leur fut plus utile d’entreprendre des réformes politiques et de se pourvoir d’un poste de ministre ou de premier ministre d’un Etat insulaire encore indépendant.

  20. Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial.

    Science.gov (United States)

    Thiese, Matthew S; Hughes, Matthew; Biggs, Jeremy

    2013-03-28

    Non-invasive electrotherapy is commonly used for treatment of chronic low back pain. Evidence for efficacy of most electrotherapy modalities is weak or lacking. This study aims to execute a high-quality, double-blinded randomized controlled clinical trial comparing 1) H-Wave(®) Device stimulation plus usual care with 2) transcutaneous electrical nerve stimulation (TENS) plus usual care, and 3) Sham electrotherapy plus usual care to determine comparative efficacy for treatment of chronic non-specific low back pain patients. Chronic non-specific low back pain patients between ages of 18-65 years, with pain of at least 3 months duration and minimal current 5/10 VAS pain. Patients will have no significant signs or symptoms of lumbosacral nerve impingement, malignancy, spinal stenosis, or mood disorders. Double blind RCT with 3 arms and 38 subjects per arm. Randomization by permuted blocks of random length, stratified by Workers Compensation claim (yes vs. no), and use of opioids. The null hypothesis of this study is that there are no statistically significant differences in functional improvement between treatment types during and at the end of a 12-week week treatment period. Subjective data will be collected using Filemaker Pro™ database management collection tools. Objective data will be obtained through functional assessments. Data will be collected at enrollment and at 1, 4, 8, and 12 weeks for each participant by a blinded assessor. H-Wave(®) device stimulation (Intervention A) plus usual care, transcutaneous electrical nerve stimulation (TENS) (Intervention B) plus usual care, and sham electrotherapy plus usual care (control). Each treatment arm will have identical numbers of visits (4) and researcher contact time (approximately 15 hours). Oswestry Disability Index. Secondary measures include: Rowland Morris Instrument, VAS pain score, functional evaluation including strength when pushing and pulling, pain free range of motion in flexion and extension

  1. Clinical Trials

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    Full Text Available ... resources to the strategies and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking part in a clinical trial is different ...

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

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

  4. Clinical Trials

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    Full Text Available ... more screening tests to see which test produces the best results. Some companies and groups sponsor clinical trials that test the ... and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

  5. Clinical Trials

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    Full Text Available ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Clinical trials for children have the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ...

  6. Clinical Trials

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    Full Text Available ... give permission for their child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Find a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  7. Clinical Trials

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    Full Text Available ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment options. Together, you can make the ... more about, or taking part in, clinical trials, talk with your doctor. He or she may know about ... clinical trials. NIH Clinical Research Studies ...

  8. Effects of nonsurgical periodontal treatment on glycated haemoglobin on type 2 diabetes patients (PARODIA 1 study): a randomized controlled trial in a sub-Saharan Africa population.

    Science.gov (United States)

    Tsobgny-Tsague, Nadia-Flore; Lontchi-Yimagou, Eric; Nana, Arnel Redon Nana; Tankeu, Aurel T; Katte, Jean Claude; Dehayem, Mesmin Y; Bengondo, Charles Messanga; Sobngwi, Eugene

    2018-02-26

    mean 8.9 ± 0.9% at baseline vs 8.1 ± 2.6% after 3 months (p = 0.24). Non-surgical periodontal treatment markedly improved glycaemic control with an attributable reduction of 2.2 points of HbA1c in poorly controlled T2D patients in a sub Saharan setting. ClinicalTrials.gov Identifier: NCT02745015 Date of registration: July 17, 2016 'Retrospectively registered'.

  9. Orange juice consumption and its effect on blood lipid profile and indices of the metabolic syndrome; a randomised, controlled trial in an at-risk population.

    Science.gov (United States)

    Simpson, E J; Mendis, B; Macdonald, I A

    2016-04-01

    Data from epidemiological and in vitro studies suggest that orange juice (OJ) may have a positive impact on lipid metabolism. However, there have been reports in the media claiming detrimental consequences of 100% juice consumption, including weight-gain and adverse effects on insulin sensitivity and blood lipid profile. The effect of daily OJ consumption was assessed using a randomised, placebo-controlled, single-blinded, parallel group design. Thirty-six overweight, but otherwise healthy men (40-60 years; 27-35 kg m(-2)) with elevated fasting serum cholesterol (5-7 mmol l(-1)), were recruited from the general UK population. None were using nutritional strategies or medication to lower their cholesterol, nor were regular consumers of citrus products. Assessment of BMI, HOMA-IR, and circulating lipid (total cholesterol, low-density lipoprotein, high-density lipoprotein, non-esterified fatty acids, triacylglycerol, apolipoprotein-A1 and apolipoprotein-B) concentrations, was made when fasted before (V1) and after a 12-week intervention (V2), during which participants consumed 250 ml per d of OJ or an energy and sugars-matched orange-flavoured drink (control). The two groups were matched at V1 with respect to all parameters described above. Although triacylglycerol concentration was similar between the groups at both visits, a trend for the change in this variable to differ between groups was observed (P = 0.060), with those in control exhibiting a significant increase in triacylglycerol at V2, compared with V1. In OJ, those with the highest initial triacylglycerol concentration showed the greatest reduction at V2 (R(2) = 0.579; P consumption of 250 ml per d of OJ did not adversely affect insulin sensitivity, circulating lipids or body weight.

  10. Reduction of body fat and improved lipid profile associated with daily consumption of a Puer tea extract in a hyperlipidemic population: a randomized placebo-controlled trial.

    Science.gov (United States)

    Jensen, Gitte S; Beaman, Joni L; He, Yi; Guo, Zhixin; Sun, Henry

    2016-01-01

    The goal for this study was to evaluate the effects of daily consumption of Puer tea extract (PTE) on body weight, body-fat composition, and lipid profile in a non-Asian population in the absence of dietary restrictions. A randomized, double-blind, placebo-controlled study design was used. A total of 59 overweight or mildly obese subjects were enrolled upon screening to confirm fasting cholesterol level at or above 220 mg/dL (5.7 mmol/dL). After giving informed consent, subjects were randomized to consume PTE (3 g/day) or placebo for 20 weeks. At baseline and at 4-week intervals, blood lipids, C-reactive protein, and fasting blood glucose were evaluated. A dual-energy X-ray absorptiometry scan was performed at baseline and at study exit to evaluate changes to body composition. Appetite and physical and mental energy were scored at each visit using visual analog scales (0-100). Consumption of PTE was associated with statistically significant weight loss when compared to placebo (PConsumption of PTE was associated with improvements to lipid profile, including a mild reduction in cholesterol and the cholesterol:high-density lipoprotein ratio after only 4 weeks, as well as a reduction in triglycerides and very small-density lipoproteins, where average blood levels reached normal range at 8 weeks and remained within normal range for the duration of the study (Pconsumption of PTE was associated with significant weight loss, reduced body mass index, and an improved lipid profile.

  11. MAGNETIC VT study: a prospective, multicenter, post-market randomized controlled trial comparing VT ablation outcomes using remote magnetic navigation-guided substrate mapping and ablation versus manual approach in a low LVEF population.

    Science.gov (United States)

    Di Biase, Luigi; Tung, Roderick; Szili-Torok, Tamás; Burkhardt, J David; Weiss, Peter; Tavernier, Rene; Berman, Adam E; Wissner, Erik; Spear, William; Chen, Xu; Neužil, Petr; Skoda, Jan; Lakkireddy, Dhanunjaya; Schwagten, Bruno; Lock, Ken; Natale, Andrea

    2017-04-01

    Patients with ischemic cardiomyopathy (ICM) are prone to scar-related ventricular tachycardia (VT). The success of VT ablation depends on accurate arrhythmogenic substrate localization, followed by optimal delivery of energy provided by constant electrode-tissue contact. Current manual and remote magnetic navigation (RMN)-guided ablation strategies aim to identify a reentry circuit and to target a critical isthmus through activation and entrainment mapping during ongoing tachycardia. The MAGNETIC VT trial will assess if VT ablation using the Niobe™ ES magnetic navigation system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT and low ejection fraction. This is a randomized, single-blind, prospective, multicenter post-market study. A total of 386 subjects (193 per group) will be enrolled and randomized 1:1 between treatment with the Niobe ES system and treatment via a manual procedure at up to 20 sites. The study population will consist of patients with ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) of ≤35% and implantable cardioverter defibrillator (ICD) who have sustained monomorphic VT. The primary study endpoint is freedom from any recurrence of VT through 12 months. The secondary endpoints are acute success; freedom from any VT at 1 year in a large-scar subpopulation; procedure-related major adverse events; and mortality rate through 12-month follow-up. Follow-up will consist of visits at 3, 6, 9, and 12 months, all of which will include ICD interrogation. The MAGNETIC VT trial will help determine whether substrate-based ablation of VT with RMN has clinical advantages over manual catheter manipulation. Clinicaltrials.gov identifier: NCT02637947.

  12. Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial

    Directory of Open Access Journals (Sweden)

    de Kort Nelleke

    2011-08-01

    Full Text Available Abstract Background Low back pain (LBP, with high incidence and prevalence rate, is one of the most common reasons to consult the health system and is responsible for a significant amount of sick leave, leading to high health and social costs. The objective of the study is to assess the cost-effectiveness and cost-utility analysis of a multidisciplinary biopsychosocial educational group intervention (MBEGI of non-specific sub-acute LBP in comparison with the usual care in the working population recruited in primary healthcare centres. Methods/design The study design is a cost-effectiveness and cost-utility analysis of a MBEGI in comparison with the usual care of non-specific sub-acute LBP. Measures on effectiveness and costs of both interventions will be obtained from a cluster randomised controlled clinical trial carried out in 38 Catalan primary health care centres, enrolling 932 patients between 18 and 65 years old with a diagnosis of non-specific sub-acute LBP. Effectiveness measures are: pharmaceutical treatments, work sick leave (% and duration in days, Roland Morris disability, McGill pain intensity, Fear Avoidance Beliefs (FAB and Golberg Questionnaires. Utility measures will be calculated from the SF-12. The analysis will be performed from a social perspective. The temporal horizon is at 3 months (change to chronic LBP and 12 months (evaluate the outcomes at long term. Assessment of outcomes will be blinded and will follow the intention-to-treat principle. Discussion We hope to demonstrate the cost-effectiveness and cost-utility of MBEGI, see an improvement in the patients' quality of life, achieve a reduction in the duration of episodes and the chronicity of non-specific low back pain, and be able to report a decrease in the social costs. If the intervention is cost-effectiveness and cost-utility, it could be applied to Primary Health Care Centres. Trial registration ISRCTN: ISRCTN58719694

  13. Perceptions of the Coach–Athlete Relationship Predict the Attainment of Mastery Achievement Goals Six Months Later: A Two-Wave Longitudinal Study among F. A. Premier League Academy Soccer Players

    Directory of Open Access Journals (Sweden)

    Adam R. Nicholls

    2017-05-01

    Full Text Available All football teams that compete within the F. A. Premier League possess an academy, whose objective is to produce more and better home-grown players that are capable of playing professionally. These young players spend a large amount of time with their coach, but little is known about player’s perception of the coach–athlete relationship within F. A. Premier League Academies. The objectives of this study were to examine whether perceptions of the coach–athlete relationship changed over six months and if the coach–athlete relationship predicted self-reported goal achievement among F. A. Premier League academy players. This study included cross-sectional (n = 104 and longitudinal (n = 52 assessments, in which academy soccer players completed a measure of the coach–athlete relationship and goal achievement across either one or two time periods. The cross-sectional data were subjected to bivariate correlations, whereas the longitudinal data were analyzed using multiple regressions. Perceptions of the coach–athlete relationship remained stable over time. The coach–athlete relationship predicted the achievement of mastery goals six months later. Enhancing the quality of the coach–athlete relationship among elite adolescent athletes appears to be a suitable way of maximizing mastery achievement goals, particularly among developmental athletes who participate in team sports.

  14. Reduction of body fat and improved lipid profile associated with daily consumption of a Puer tea extract in a hyperlipidemic population: a randomized placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Jensen GS

    2016-03-01

    Full Text Available Gitte S Jensen,1 Joni L Beaman,1 Yi He,2 Zhixin Guo,2 Henry Sun31NIS Labs, Klamath Falls, OR, USA; 2Modern TCM Research Center, Tasly Academy, Tianjin, People’s Republic of China; 3Tasly Pharmaceuticals Inc, Rockville, MD, USA Objective: The goal for this study was to evaluate the effects of daily consumption of Puer tea extract (PTE on body weight, body-fat composition, and lipid profile in a non-Asian population in the absence of dietary restrictions.Materials and methods: A randomized, double-blind, placebo-controlled study design was used. A total of 59 overweight or mildly obese subjects were enrolled upon screening to confirm fasting cholesterol level at or above 220 mg/dL (5.7 mmol/dL. After giving informed consent, subjects were randomized to consume PTE (3 g/day or placebo for 20 weeks. At baseline and at 4-week intervals, blood lipids, C-reactive protein, and fasting blood glucose were evaluated. A dual-energy X-ray absorptiometry scan was performed at baseline and at study exit to evaluate changes to body composition. Appetite and physical and mental energy were scored at each visit using visual analog scales (0–100.Results: Consumption of PTE was associated with statistically significant weight loss when compared to placebo (P<0.05. Fat loss was seen for arms, legs, and the gynoid region (hip/belly, as well as for total fat mass. The fat reduction reached significance on within-group analysis, but did not reach between-group significance. Consumption of PTE was associated with improvements to lipid profile, including a mild reduction in cholesterol and the cholesterol:high-density lipoprotein ratio after only 4 weeks, as well as a reduction in triglycerides and very small-density lipoproteins, where average blood levels reached normal range at 8 weeks and remained within normal range for the duration of the study (P<0.08. No significant changes between the PTE group and the placebo group were seen for fasting glucose or C

  15. The Mobile Insulin Titration Intervention (MITI) for Insulin Glargine Titration in an Urban, Low-Income Population: Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Levy, Natalie; Moynihan, Victoria; Nilo, Annielyn; Singer, Karyn; Bernik, Lidia S; Etiebet, Mary-Ann; Fang, Yixin; Cho, James; Natarajan, Sundar

    2015-03-13

    Patients on insulin glargine typically visit a clinician to obtain advice on how to adjust their insulin dose. These multiple clinic visits can be costly and time-consuming, particularly for low-income patients. It may be feasible to achieve insulin titration through text messages and phone calls with patients instead of face-to-face clinic visits. The objectives of this study are to (1) evaluate if the Mobile Insulin Titration Intervention (MITI) is clinically effective by helping patients reach their optimal dose of insulin glargine, (2) determine if the intervention is feasible within the setting and population, (3) assess patient satisfaction with the intervention, and (4) measure the costs associated with this intervention. This is a pilot study evaluating an approach to insulin titration using text messages and phone calls among patients with insulin-dependent type 2 diabetes in the outpatient medical clinic of Bellevue Hospital Center, a safety-net hospital in New York City. Patients will be randomized in a 1:1 ratio to either the MITI arm (texting/phone call intervention) or the usual-care arm (in-person clinic visits). Using a Web-based platform, weekday text messages will be sent to patients in the MITI arm, asking them to text back their fasting blood glucose values. In addition to daily reviews for alarm values, a clinician will rereview the texted values weekly, consult our physician-approved titration algorithm, and call the patients with advice on how to adjust their insulin dose. The primary outcome will be whether or not a patient reaches his/her optimal dose of insulin glargine within 12 weeks. Recruitment for this study occurred between June 2013 and December 2014. We are continuing to collect intervention and follow-up data from our patients who are currently enrolled. The results of our data analysis are expected to be available in 2015. This study explores the use of widely-available text messaging and voice technologies for insulin titration

  16. Autour d'un mystère de l'histoire du livre. Les trois versions du premier volume du Voyage pittoresque de Choiseul-Gouffier

    Directory of Open Access Journals (Sweden)

    Ioannis Koubourlis

    2009-01-01

    Full Text Available Dans cet article, il est question d'un grand mystère de l'histoire du livre, celui de l'existence de trois versions différentes du premier volume du Voyage pittoresque de la Grèce (1782 de Choiseul-Gouffier, c'est-à-dire d'un ouvrage majeur pour la floraison des idées philhellènes dans l'Europe des XVIIIe-XIXe siècles. On sait, grâce à la correspondance de l'auteur, qu'il avait pris la décision de réviser son texte dès 1783, en raison de sa candidature pour le poste d'Ambassadeur de France à Constantinople. Par contre, on n'en sait pas davantage sur le lieu et le temps exacts où il a travaillé les deux nouvelles versions, portant également la date 1782, ni d'ailleurs sur les circonstances de leur édition. Sur la base d'une étude comparative des trois versions du texte, qui met l'accent sur l'argumentation avancée chaque fois par l'auteur, nous formulons ici une série d'hypothèses pour l'interprétation de ce mystère, que nous allons examiner dans leurs détails à partir d'une étude de bibliologie qui suivra le présent article.

  17. Girassol. A world premiere; Girassol. Une premiere mondiale

    Energy Technology Data Exchange (ETDEWEB)

    Magnan, J.Ph.; Serceau, A. [TotalFinaElf, La Defense, 92 - Courbevoie (France)

    2002-06-01

    Located at 150 km of the Angola coast, Girassol is the very first oil field integrally developed in deep sea conditions (1400 m). Girassol ensures today 8% of the production operated by TotalFinaElf company. This first step announces two other developments of comparable size on the same bloc (17): Dalia and Rosa-Lirio. This project, carried out with the participation of Angola companies, required 2.8 billions of US$ of investment. It significantly contributes to the development of a particularly rich oil province. This article describes the production equipment of the field: FPSO (floating production storage off-loading), mooring, tower risers, injection and production wells, bundles, flow-lines etc.. and the underwater operations required for the connecting of the bottom and surface equipments. (J.S.)

  18. Prevalence of high-risk human papilloma virus genotypes and associated risk of cervical precancerous lesions in a large U.S. screening population: data from the ATHENA trial.

    Science.gov (United States)

    Monsonego, Joseph; Cox, J Thomas; Behrens, Catherine; Sandri, Maria; Franco, Eduardo L; Yap, Poh-Sin; Huh, Warner

    2015-04-01

    We assessed the age-related prevalence of high risk human papillomavirus (HR-HPV) genotypes and the genotype-associated risk for high-grade cervical intraepithelial neoplasia (CIN) in a large U.S. screening population. A total of 40,901 women aged ≥25 years were screened with liquid-based cytology and HPV testing in the ATHENA (Addressing the Need for Advanced HPV Diagnostics) trial. Genotyping was performed using the LINEAR ARRAY HPV Genotyping Test. HPV16 was the most prevalent genotype in all age groups, ranging from 3.5% to 0.8% in women aged 25-29 and ≥50 years, respectively. The next most prevalent genotypes were HPV52, HPV31 and HPV18. In the overall population, HPV16 conferred the greatest absolute risk of ≥CIN3 both in women aged 25-29 and ≥30 years (14.2% and 15.1%, respectively) followed by HPV31 (8.0% and 7.9%), HPV52 (6.7% and 4.4%) and HPV18 (2.7% and 9.0%). Similar trends were seen in women with negative cytology. The percent positivity increased markedly with disease progression for HPV16 and HPV18 which were responsible for 45.6% and 8.4% of ≥CIN3, respectively. Of note, HPV 18 was responsible for 50% of adenocarcinoma in situ (AIS) and 50% of invasive cancer cases. HPV16 played a major role in the development of ≥CIN3 irrespective of age, supporting the identification of HPV16 in primary screening for all women. Identification of HPV18 is also warranted, given its significant contribution to AIS and cancer. Identification of non-16/18 genotypes as a pool should provide sufficient information for screening. Copyright © 2015. Published by Elsevier Inc.

  19. Clinical Trials

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    Full Text Available ... part. Randomization Most clinical trials that have comparison groups use randomization. This involves assigning patients to different comparison groups by chance, rather than choice. This ...

  20. Premier Hospital Quality Incentive Demonstration

    Data.gov (United States)

    U.S. Department of Health & Human Services — CMS is pursuing a vision to improve the quality of health care by expanding the information available about quality of care and through direct incentives to reward...

  1. Enhancing Classroom Creativity. Premier PD

    Science.gov (United States)

    Luna, Elizabeth; Ernst, Jeremy; Clark, Aaron; DeLuca, V. William; Kelly, Daniel

    2018-01-01

    Educators often hear about the need for students to be more creative, more free-thinking, and more exploratory throughout projects and class assignments. This article will highlight the importance of creating and implementing an open-classroom environment where students are confident in their ability to ask questions and capable of exploring a…

  2. Stepwise strategy to improve Cervical Cancer Screening Adherence (SCAN-CC): automated text messages, phone calls and face-to-face interviews: protocol of a population-based randomised controlled trial.

    Science.gov (United States)

    Firmino-Machado, João; Mendes, Romeu; Moreira, Amélia; Lunet, Nuno

    2017-10-05

    Screening is highly effective for cervical cancer prevention and control. Population-based screening programmes are widely implemented in high-income countries, although adherence is often low. In Portugal, just over half of the women adhere to cervical cancer screening, contributing for greater mortality rates than in other European countries. The most effective adherence raising strategies are based on patient reminders, small/mass media and face-to-face educational programmes, but sequential interventions targeting the general population have seldom been evaluated. The aim of this study is to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organised cervical cancer screening: step 1a-customised text message invitation; step 1b-customised automated phone call invitation; step 2-secretary phone call; step 3-family health professional phone call and face-to-face appointment. A population-based randomised controlled trial will be implemented in Portuguese urban and rural areas. Women eligible for cervical cancer screening will be randomised (1:1) to intervention and control. In the intervention group, women will be invited for screening through text messages, automated phone calls, manual phone calls and health professional appointments, to be applied sequentially to participants remaining non-adherent after each step. Control will be the standard of care (written letter). The primary outcome is the proportion of women adherent to screening after step 1 or sequences of steps from 1 to 3. The secondary outcomes are: proportion of women screened after each step (1a, 2 and 3); proportion of text messages/phone calls delivered; proportion of women previously screened in a private health institution who change to organised screening. The intervention and control groups will be compared based on intention-to-treat and per-protocol analyses. The study was approved by the Ethics Committee of the Northern Health

  3. Age, breed, sex distribution and nutrition of a population of working farm dogs in New Zealand: results of a cross-sectional study of members of the New Zealand Sheep Dog Trial Association.

    Science.gov (United States)

    Singh, I; Tucker, L A; Gendall, P; Rutherfurd-Markwick, K J; Cline, J; Thomas, D G

    2011-05-01

    To establish baseline information about age, breed, sex distribution and feeding practices for a population of working farm dogs owned by members of the New Zealand Sheep Dog Trial Association (NZSDTA) throughout New Zealand. Questionnaires were sent to members of the NZSDTA in August 2007, requesting information on the size and terrain of the farms where they worked, as well as the breed, weight, age and sex of each working dog they owned, feeding regime employed, diet fed, work levels, and general health of their dogs. The survey was completed by 542/676 (81%) of the eligible sample population, and provided information on 2,861 dogs, excluding those dog owners surveyed worked on sheep and beef-cattle farms. The median farm size was 440 [Inter-quartile range (IQR) 132-1,200] ha and varied with region. The majority of farms were situated on either hill country (184/542; 34%) or a mixture of hilly and flat terrain (260/542; 48%), and had a median of six (IQR 5-8) working dogs per farm. The median age of dogs was 3.0 (IQR 2.0-6.0) years. Heading dogs were the most common type of working dog (1,510/2,861; 52.8%), followed by Huntaways (1,161/2,861; 40.6%). The gender distribution of all dogs was biased towards males (57%), but this decreased with age. There was a positive association between the number of dogs on a farm and perceived level of tiredness of dogs (pdogs once a day. The most common diet fed was a combination of dry food and homekill, which was fed by 328/542 (61%) owners during peak and 313/542 (58%) during off-peak periods of work. This study has established baseline information on the age, breed, gender and nutrition of a large population of working farm dogs in New Zealand. Current feeding practices employed by owners include offering a substantial amount of homekill to their animals. Homekill may be deficient or marginal in vitamins and minerals, therefore opportunities could exist to improve the diets and therefore the longevity and performance of

  4. A clinical trial to assess the immunogenicity and safety of Inactivated Influenza Vaccine (Whole Virion IP (Pandemic Influenza (H1N1 2009 Monovalent Vaccine; VaxiFlu-S ™ in healthy Indian adult population

    Directory of Open Access Journals (Sweden)

    A H Kubavat

    2011-01-01

    Full Text Available Background : The pandemic of H1N1 2009 influenza has spread world over and low degree of virus transmission has continued in several regions of India. Aims : To assess the immunogenicity and safety of Pandemic Influenza (H1N1 2009 Monovalent Vaccine in healthy adult Indian population. Settings and Design : Prospective, open label, multicentric, phase 2/3 clinical trial. Materials and Methods : Healthy adult Indian subjects belonging to either 18-59 years or ≥60 years age groups were enrolled and administered a single 0.5 ml (≥15 mcg of hemagglutinin antigen dose of vaccine in the deltoid muscle. Anti-hemagglutinin antibody titer was assessed at baseline and 21 (±2 days after vaccination by Hemagglutination Inhibition (HI test. Safety assessments were done for a period of 42 days. Statistical Analysis Used : Percentages of appropriate population with 95% confidence intervals calculated, log transformation of the data to calculate Geometric Mean Titers (GMTs and chi-square test and student′s t-test applied for significance testing. Results : 182/198 and 53/63 volunteers in age groups of 18-59 years and ≥60 years, respectively, achieved an HI titer ≥1 : 40 at Day 21 (91.9% [95% confidence interval: 88.1-95.7%] and 84.1% [75.1-93.2%]; P=0.072. Further, 171/198 and 50/63 volunteers in the respective age groups achieved seroconversion/four-fold increase in titer at Day 21 (86.4% [81.6-91.1%] and 79.4% [69.4-89.4%]; P=0.179. A significant rise of 22.6-fold [18.0-28.4] and 10.5-fold [7.4-15.0] was noted in GMT in the respective age groups (P<0.001 for both groups as compared to baseline. Nine vaccine-related adverse events were reported (3.4% incidence [1.2-5.6%], which were of low severity only. Conclusions : Pandemic Influenza (H1N1 2009 Monovalent Vaccine produces excellent immunogenic response with a good tolerability profile in adult Indian population.

  5. Clinical Trials

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    Full Text Available ... trial found that one of the combinations worked much better than the other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI ...

  6. Clinical Trials

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    Full Text Available ... the clinical trial you take part in, the information gathered can help others and add to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care. Many people volunteer because ...

  7. Clinical Trials

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    Full Text Available ... from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative ... safe a treatment is or how well it works. Children (aged 18 and younger) get ... legal consent for their child to take part in a clinical trial. When ...

  8. Clinical Trials

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    Full Text Available ... other expenses (for example, travel and child care)? Who will be in charge of my care? What will happen after the trial? Taking part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

  9. Clinical Trials

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

  10. Clinical Trials

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    Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ... clinical trials are vital to the process of improving medical care. Many people ... participants, it may not work for you. A new treatment may have side ...

  11. Clinical Trials

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    Full Text Available ... Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ... phase II clinical trials. The risk of side effects might be even greater for ... treatments. Health insurance and health care providers don't always ...

  12. Clinical Trials

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    Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, talk with your doctor. He or she may know about studies going on in your area. You can visit the following website to learn more about ...

  13. Clinical Trials

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    Full Text Available ... benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials ... child to enroll. Also, children aged 7 and older often must agree (assent) to ... as clinical trials for adults. For more information, go to "How Do Clinical ...

  14. Clinical Trials

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    Full Text Available ... products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ... cancer also increased. As a result, the U.S. Food and Drug Administration now recommends never using HT ... Clinical Trials Work If you take ...

  15. Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic sub-acute low back pain in the working population: cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Roura-Olivan Mercè

    2010-01-01

    Full Text Available Abstract Background Non-specific low back pain is a common cause for consultation with the general practitioner, generating increased health and social costs. This study will analyse the effectiveness of a multidisciplinary intervention to reduce disability, severity of pain, anxiety and depression, to improve quality of life and to reduce the incidence of chronic low back pain in the working population with non-specific low back pain, compared to usual clinical care. Methods/Design A Cluster randomised clinical trial will be conducted in 38 Primary Health Care Centres located in Barcelona, Spain and its surrounding areas. The centres are randomly allocated to the multidisciplinary intervention or to usual clinical care. Patients between 18 and 65 years old (n = 932; 466 per arm and with a diagnostic of a non-specific sub-acute low back pain are included. Patients in the intervention group are receiving the recommendations of clinical practice guidelines, in addition to a biopsychosocial multidisciplinary intervention consisting of group educational sessions lasting a total of 10 hours. The main outcome is change in the score in the Roland Morris disability questionnaire at three months after onset of pain. Other outcomes are severity of pain, quality of life, duration of current non-specific low back pain episode, work sick leave and duration, Fear Avoidance Beliefs and Goldberg Questionnaires. Outcomes will be assessed at baseline, 3, 6 and 12 months. Analysis will be by intention to treat. The intervention effect will be assessed through the standard error of measurement and the effect-size. Responsiveness of each scale will be evaluated by standardised response mean and receiver-operating characteristic method. Recovery according to the patient will be used as an external criterion. A multilevel regression will be performed on repeated measures. The time until the current episode of low back pain takes to subside will be analysed by Cox

  16. The Impact of Massage Therapy on Function in Pain Populations—A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part I, Patients Experiencing Pain in the General Population

    Science.gov (United States)

    Crawford, Cindy; Boyd, Courtney; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Yang, EunMee; Zhang, Weimin; Buckenmaier, Chester; Buckenmaier, Pamela; Cambron, Jerrilyn; Deery, Christopher; Schwartz, Jan; Werner, Ruth; Whitridge, Pete

    2016-01-01

    Abstract Purpose Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of massage therapy research and evidence for its efficacy in treating pain, function-related and health-related quality of life outcomes across all pain populations. Methods Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A diverse steering committee interpreted the results to develop recommendations. Results Sixty high quality and seven low quality studies were included in the review. Results demonstrate massage therapy effectively treats pain compared to sham [standardized mean difference (SMD) = −.44], no treatment (SMD = −1.14), and active (SMD = −0.26) comparators. Compared to active comparators, massage therapy was also beneficial for treating anxiety (SMD = −0.57) and health-related quality of life (SMD = 0.14). Conclusion Based on the evidence, massage therapy, compared to no treatment, should be strongly recommended as a pain management option. Massage therapy is weakly recommended for reducing pain, compared to other sham or active comparators, and improving mood and health-related quality of life, compared to other active comparators. Massage therapy safety, research challenges, how to address identified research gaps, and necessary next steps for implementing massage therapy as a viable pain management option are discussed. PMID:27165971

  17. Exploiting social influence to magnify population-level behaviour change in maternal and child health: study protocol for a randomised controlled trial of network targeting algorithms in rural Honduras.

    Science.gov (United States)

    Shakya, Holly B; Stafford, Derek; Hughes, D Alex; Keegan, Thomas; Negron, Rennie; Broome, Jai; McKnight, Mark; Nicoll, Liza; Nelson, Jennifer; Iriarte, Emma; Ordonez, Maria; Airoldi, Edo; Fowler, James H; Christakis, Nicholas A

    2017-03-13

    Despite global progress on many measures of child health, rates of neonatal mortality remain high in the developing world. Evidence suggests that substantial improvements can be achieved with simple, low-cost interventions within family and community settings, particularly those designed to change knowledge and behaviour at the community level. Using social network analysis to identify structurally influential community members and then targeting them for intervention shows promise for the implementation of sustainable community-wide behaviour change. We will use a detailed understanding of social network structure and function to identify novel ways of targeting influential individuals to foster cascades of behavioural change at a population level. Our work will involve experimental and observational analyses. We will map face-to-face social networks of 30 000 people in 176 villages in Western Honduras, and then conduct a randomised controlled trial of a friendship-based network-targeting algorithm with a set of well-established care interventions. We will also test whether the proportion of the population targeted affects the degree to which the intervention spreads throughout the network. We will test scalable methods of network targeting that would not, in the future, require the actual mapping of social networks but would still offer the prospect of rapidly identifying influential targets for public health interventions. The Yale IRB and the Honduran Ministry of Health approved all data collection procedures (Protocol number 1506016012) and all participants will provide informed consent before enrolment. We will publish our findings in peer-reviewed journals as well as engage non-governmental organisations and other actors through venues for exchanging practical methods for behavioural health interventions, such as global health conferences. We will also develop a 'toolkit' for practitioners to use in network-based intervention efforts, including public

  18. Formes du regroupement pluriprofessionnel en soins de premiers recours. Une typologie des maisons, pôles et centres de santé participant aux Expérimentations des nouveaux modes de rémunération (ENMR)

    OpenAIRE

    Anissa Afrite; Julien Mousques

    2014-01-01

    Dans le cadre d’un programme de recherche global sur le lien entre le regroupement pluriprofessionnel en soins de premiers recours dans les sites participant aux Expérimentations des nouveaux modes de rémunération (ENMR) et la performance des médecins généralistes en matière d’activité, de productivité, d’efficacité et d’efficience de leurs pratiques, cette recherche a pour objectif d’analyser la structure, l’organisation et le fonctionnement des maisons, pôles et centres de santé participant...

  19. Clinical Trials

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    Full Text Available ... include factors such as a patient's age and gender, the type and stage of disease, and whether ... How long will the trial last? Who will pay for the tests and treatments I receive? Will ...

  20. Clinical Trials

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

  1. Clinical Trials

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    Full Text Available ... strict scientific standards. These standards protect patients and help produce reliable study results. Clinical trials are one ... are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding The National ...

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

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    Full Text Available ... and compare new treatments with other available treatments. Steps To Avoid Bias The researchers doing clinical trials take steps to avoid bias. "Bias" means that human choices ...

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    Full Text Available ... gathered can help others and add to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care. Many people volunteer because they want to help others. ...

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

  6. Clinical Trials

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

  7. Clinical Trials

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    Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ... the new approach. You also will have the support of a team of health care providers, who ...

  8. Clinical Trials

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

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

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

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

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

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

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

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    Full Text Available ... clinical trials are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees all research ...

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    Full Text Available ... clinical trial. IRB members are doctors, statisticians, and community members. The IRB's purpose is to ensure that ... lung, and blood disorders. By engaging the research community and a broad group of stakeholders and advisory ...

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    Full Text Available ... successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, ... gathered can help others and add to scientific knowledge. People who take part in clinical trials are ...

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

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

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

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

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    Full Text Available ... risk of heart disease in the first few years, and HT also increased the risk of stroke ... a safety measure. They ensure a trial excludes any people for whom the protocol has known risks ...

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

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

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

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    Full Text Available ... Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood ... of estrogen and progestin, the risk of breast cancer also increased. As a result, the U.S. Food ...

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

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

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

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

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

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    Full Text Available ... clinical care of children, more studies are needed focusing on children's health with the goal to develop ... study? How might this trial affect my daily life? Will I have to be in the hospital? ...

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    Full Text Available ... procedures painful? What are the possible risks, side effects, and benefits of taking part in the study? How might this trial affect my daily life? Will I have to be in the hospital? ...

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

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    Full Text Available ... sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; ... age and frequency for doing screening tests, such as mammography; and compare two or more screening tests ...

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    Full Text Available ... harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits. ... explore whether surgery or other medical treatments produce better results for certain illnesses or groups of people; ...

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

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    Full Text Available ... Blood Safety Sleep Science and Sleep Disorders Lung Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, ... whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ...

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    Full Text Available ... patients. Usually, a computer program makes the group assignments. Masking The term "masking" refers to not telling ... questions to ask your doctor and the research staff, go to "How Do Clinical Trials Protect Participants?" ...

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

  1. Clinical Trials

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

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

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

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    Full Text Available ... Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in ... Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain ...

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

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    Full Text Available ... Science Science Home Blood Disorders and Blood Safety Sleep Science and Sleep Disorders Lung Diseases Heart and Vascular Diseases Precision ... women and that are ethnically diverse. Children also need clinical trials that focus on them, as medical ...

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

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

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    Full Text Available ... whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ... also was increasingly being used for prevention of heart disease.) The study found that HT increased the risk ...

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

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

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    Full Text Available ... NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory Committees Budget ... always, parents must give legal consent for their child to take part in a clinical trial. When ...

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

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

  15. Clinical Trials

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    Full Text Available ... that the participants' rights are protected. The IRB reviews the trial's protocol before the study begins. An IRB will only approve research that deals with medically important questions ...

  16. Clinical Trials

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    Full Text Available ... women and that are ethnically diverse. Children also need clinical trials that focus on them, as medical ... often differ for children. For example, children may need lower doses of certain medicines or smaller medical ...

  17. Clinical Trials

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

  18. Clinical Trials

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

  19. Clinical Trials

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    Full Text Available ... new treatments in small groups of people for safety and side effects. Phase II clinical trials look at how well treatments work and further review these treatments for safety. Phase ...

  20. Clinical Trials

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    Full Text Available ... Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood ... these results are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding ...

  1. Clinical Trials

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    Full Text Available ... and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense ... FOIA) Accessibility Copyright and Usage No FEAR Act Grants and Funding Building 31 31 Center Drive Bethesda, ...

  2. Clinical Trials

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    Full Text Available ... to preexisting differences between the patients. Usually, a computer program makes the group assignments. Masking The term " ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ...

  3. Clinical Trials

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    Full Text Available ... as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes ... for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, ...

  4. Clinical Trials

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    Full Text Available ... treatment of menopausal symptoms. It also was increasingly being used for prevention of heart disease.) The study ... a trial are due to the different strategies being used, not to preexisting differences between the patients. ...

  5. Clinical Trials

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

  6. Clinical Trials

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

  7. Clinical Trials

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

  8. Évolution nycthémérale des composantes biochimiques du phytoplancton de la retenue du barrage Idriss premier (Fès, Maroc)

    Science.gov (United States)

    Bahhou, J.; Alaoui Mhamdi, M.

    1999-03-01

    The diel changes of the biochemical composition of the phytoplankton were studied in the Idriss first reservoir (located on the Inaouen river at thirty Km from the city of Fes, Morrocco) during September 1994. Several biomass and metabolic indicators (proteins, carbohydrates, lipids, chlorophyll a and primary production) were assessed every fourth hour over tow days (7, 8 and 9 September). Since the Protein/Carbohydrates ratio (P/C) is largely recognised as a good integrator of the metabolic functions of the cells, we examined its distribution pattern concomitantly with aforementioned parameters. The results demonstrated enhanced P/C ratios clearly indicating that nutrients were sufficiently available for growth. In addition, this index showed a diel significant variation with levels higher in the night than in the day. Moreover, these results suggest that phytoplankton species during the night used the day-synthesised carbohydrates to insure the cell metabolic functioning. The P/C presents relatively high values in proposition to the ones that have been recorded in temperate regions, and seems to be related to azotic inputs of the Inaouen river. Dans le but de parfaire nos connaissances sur le fonctionnement du sous écosystème phytoplancton, nous nous sommes intéressés à étudier son cycle nycthéméral et son métabolisme cellulaire dans la retenue du barrage Idriss premier. Cette dernière, construite sur l'Oued Inaouène, est située à une trentaine de Km de la ville de Fès. Au cours de ce cycle, les prélèvements ont été effectués selon une séquence temporelle de 4 heures pendant 48 heures, les 7, 8 et 9 septembre 1994. L'étude de l'évolution des composantes biochimiques des cellules phytoplanctoniques à savoir les protéines, les glucides et les lipides a permis de mettre en évidence des variations nycthémérales importantes. Ces variations sont d'autant plus importantes que les variations spatiales observées entre les profondeurs. De plus

  9. Using a tailored health information technology- driven intervention to improve health literacy and medication adherence in a Pakistani population with vascular disease (Talking Rx) - study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kamal, Ayeesha Kamran; Muqeet, Abdul; Farhat, Kashfa; Khalid, Wardah; Jamil, Anum; Gowani, Ambreen; Muhammad, Aliya Amin; Zaidi, Fabiha; Khan, Danyal; Elahi, Touseef; Sharif, Shahrukh; Raz, Sibtain; Zafar, Taha; Bokhari, Syedah Saira; Rahman, Nasir; Sultan, Fateh Ali Tipoo; Sayani, Saleem; Virani, Salim S

    2016-03-05

    the intervention and the control arm. We estimate that a sample size of 86 participants in each arm will be able to detect a difference of 1 point on the MMAS with a power of 90 % and significance level of 5 %. Accounting for an attrition rate of 15 %, we plan to enroll 100 participants in each arm (total study population = 200). We hypothesize that a linguistically tailored health IT intervention based on IVR and SMS will be associated with an improvement in adherence (to anti-platelet and lipid-lowering medications) and an improvement in health literacy in Pakistani patients with vascular disease. This innovative study will provide early data for the feasibility of the use of IT based prescriptions in an lower middle incorme country setting with limited numeracy and literacy skills. Clinical Trials.gov: NCT02354040 - 2 February 2015.

  10. Conception et réalisation de l'unité de décision du système de déclenchement de premier niveau du détecteur LHCb au LHC

    CERN Document Server

    Laubser, Julien

    2007-01-01

    Le detecteur LHCb est l'une des quatre experiences de physique des particules installees sur la nouvelle chaine d'acceleration LHC (Large Hadron Collider) du CERN a Geneve. Afin de reduire la quantite de donnees destinees au stockage pour les analyses hors ligne, un dispositif de selection en ligne des collisions interessantes selon la physique a etudier est mis en place en parallele de la chaine d'acquisition des donnees. Ce dispositif est compose d'un premier niveau(niveau 0) realise par un systeme electronique complexe et d'un second niveau de selection realise par informatique HLT (High Level Trigger). L'unite de decision de niveau 0 (L0DU) est le systeme central du niveau 0 de declenchement. L0DU prend la decision d'accepter ou de rejeter la collision pour ce premier niveau a partir d'une fraction d'informations issues des sous-detecteurs les plus rapides (432 bits a 80 MHz). L'unite de decision est un circuit imprime 16 couches integrant des composants de haute technologie de type FPGA (Field Programmab...

  11. Study of the first collective levels of the even-even nuclei between masses 182 and 206; Etude des premiers niveaux collectifs des noyaux pairs-pairs entre les masses 182 et 206

    Energy Technology Data Exchange (ETDEWEB)

    Barloutaud, R; Leveque, A; Lehmann, P; Quidort, J [Commissariat a l' Energie Atomique, Saclay (France).Centre d' Etudes Nucleaires

    1959-07-01

    The reduced probabilities of deexcitation of the first two 2 + levels of {sup 184}W, {sup 186}W, {sup 188}Os, {sup 190}Os, {sup 192}Os and {sup 194}Pt have been deduced from coulombic excitation experiments on these nuclei.The results are included in a chart of the properties of the first two 2 + levels of even-even nuclei situated between masses 182 and 206. The variation of these properties as a function of nuclear distortion is compared with the various theoretical predictions concerning vibration levels. (author) [French] Les probabilites reduites de desexcitation des deux premiers niveaux 2 + de {sup 184}W, {sup 186}W, {sup 188}Os, {sup 190}Os, {sup 192}Os and {sup 194}Pt ont ete deduites des experiences d'excitation coulombienne de ces noyaux. Les resultats sont inseres dans une systematique des proprietes des deux premiers niveaux 2 + des noyaux pairs-pairs situes entre les masses 182 et 206. La variation de ces proprietes en fonction de la deformation nucleaire est comparee aux diverses predictions theoriques concernant les niveaux de vibration. (auteur)

  12. HOW TO DESIGN NUTRITIONAL INTERVENTION TRIALS TO SLOW COGNITIVE DECLINE IN APPARENTLY HEALTHY POPULATIONS AND APPLY FOR EFFICACY CLAIMS: A STATEMENT FROM THE INTERNATIONAL ACADEMY ON NUTRITION AND AGING TASK FORCE

    Science.gov (United States)

    Ferry, M.; Coley, N.; Andrieu, S.; Bonhomme, C.; Caubere, J.P.; Cesari, M.; Gautry, J.; Garcia Sanchez, I.; Hugonot, L.; Mansuy, L.; Pahor, M.; Pariente, J.; Ritz, P.; Salva, A.; Sijben, J.; Wieggers, R.; Ythier-Moury, P.; Zaim, M.; Zetlaoui, J.; Vellas, B.

    2015-01-01

    Interventions are crucial as they offer simple and inexpensive public health solutions that will be useful over the long term use. A Task Force on designing trials of nutritional interventions to slow cognitive decline in older adults was held in Toulouse in September 2012. The aim of the Task Force was to bring together leading experts from academia, the food industry and regulatory agencies to determine the best trial designs that would enable us to reach our goal of maintaining or improving cognitive function in apparently healthy aging people. An associated challenge for this Task Force was to determine the type of trials required by the Public Food Agencies for assessing the impact of nutritional compounds in comparison to well established requirements for drug trials. Although the required quality of the study design, rationale and statistical analysis remains the same, the studies designed to show reduction of cognitive decline require a long duration and the objectives of this task force was to determine best design for these trials. Two specific needs were identified to support trials of nutritional interventions: 1- Risk- reduction strategies are needed to tackle the growing burden of cognitive decline that may lead to dementia, 2- Innovative study designs are needed to improve the quality of these studies. PMID:23933873

  13. The COLOFOL trial

    DEFF Research Database (Denmark)

    Hansdotter Andersson, Pernilla; Wille-Jørgensen, Peer; Horváth-Puhó, Erzsébet

    2016-01-01

    population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24......INTRODUCTION: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL...... participating centers, we scrutinized hospital inpatient data to identify all colorectal cancer patients who underwent surgery, in order to ascertain all eligible patients who were not included in the study and to compare them with enrolled patients. RESULTS: Of a total of 4,445 eligible patients, 2...

  14. Clinical Trials

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    Full Text Available ... an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment team. ...

  15. Clinical Trials

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

  16. The Trial

    Science.gov (United States)

    Bryant, Jen

    2004-01-01

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

  17. Clinical Trials

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

  18. Clinical Trials

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

  19. Clinical Trials

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    Full Text Available ... patient has had certain treatments or has other health problems. Eligibility criteria ensure that new approaches are tested ... public. What to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ...

  20. Clinical Trials

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

  1. Clinical Trials

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    Full Text Available ... edge approaches, such as gene therapy or new biological treatments. Health insurance and health care providers don't ... of a trial, early if the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and ...

  2. Clinical Trials

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

  3. Clinical Trials

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

  4. Clinical Trials

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

  5. Clinical Trials

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    Full Text Available ... benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part ... about how you feel. Some people will need to travel or stay in hospitals ...

  6. Clinical Trials

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

  7. Clinical Trials

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    Full Text Available ... As a result, the U.S. Food and Drug Administration now recommends never using HT to prevent heart disease. When HT is used for menopausal symptoms, it should be taken only at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ...

  8. Clinical Trials

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    Full Text Available ... an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  9. Clinical Trials

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

  10. Clinical Trials

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    Full Text Available ... approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start with small groups of patients to find out whether a ...

  11. Clinical Trials

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    Full Text Available ... Safety Sleep Science and Sleep Disorders Lung Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ...

  12. Clinical Trials

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    Full Text Available ... Nutrition, and Physical Activity Population and Epidemiology Studies Women’s Health All Science A-Z ... Divisions Operations and Administration Advisory Committees Budget ...

  13. Children’s Healthy Living (CHL) Program for remote underserved minority populations in the Pacific region: rationale and design of a community randomized trial to prevent early childhood obesity

    Science.gov (United States)

    2013-01-01

    Background Although surveillance data are limited in the US Affiliated Pacific, Alaska, and Hawaii, existing data suggest that the prevalence of childhood obesity is similar to or in excess of other minority groups in the contiguous US. Strategies for addressing the childhood obesity epidemic in the region support the use of community-based, environmentally targeted interventions. The Children’s Healthy Living Program is a partnership formed across institutions in the US Affiliated Pacific, Alaska, and Hawaii to design a community randomized environmental intervention trial and a prevalence survey to address childhood obesity in the region through affecting the food and physical activity environment. Methods/Design The Children’s Healthy Living Program community randomized trial is an environmental intervention trial in four matched-pair communities in American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, and Hawaii and two matched-pair communities in Alaska. A cross-sectional sample of children (goal n = 180) in each of the intervention trial communities is being assessed for outcomes at baseline and at 24 months (18 months post-intervention). In addition to the collection of the participant-based measures of anthropometry, diet, physical activity, sleep and acanthosis nigricans, community assessments are also being conducted in intervention trial communities. The Freely Associated States of Micronesia (Federated States of Micronesia, and Republics of Marshall Islands and Palau) is only conducting elements of the Children’s Healthy Living Program sampling framework and similar measurements to provide prevalence data. In addition, anthropometry information will be collected for two additional communities in each of the 5 intervention jurisdictions to be included in the prevalence survey. The effectiveness of the environmental intervention trial is being assessed based on the RE-AIM (reach, effectiveness, adoption, implementation, maintenance

  14. L’espace domestique au Bronze final et au premier âge du Fer dans le sud de la Corse

    Directory of Open Access Journals (Sweden)

    Peche-Quilichini, Kewin

    2015-12-01

    organización general como a nivel del espacio interno y de la arquitectura de las viviendas. [fr] L’objectif de cet article est de fournir une approche synthétique sur les formes de l’habitat en Corse au Bronze final (BF et au premier âge du Fer (F1, à l’échelle de la microrégion montagneuse de l’Alta Rocca, située dans le sud de la Corse, au coeur du bassin occidental de la Méditerranée. La problématique d’étude des sites protohistoriques non fortifiés est jeune sur l’île, mais les travaux se sont récemment multipliés et rendent compte de la complexité structurelle et évolutive des espaces habités, permettant ainsi une premiére analyse comparative. Le raisonnement s’appuie essentiellement sur l’apport des fouilles du grand habitat de Cuciurpula, initiées en 2008 et toujours en cours, ainsi que sur l’exploitation des villages de Puzzonu et de Nuciaresa, sondés en 2012. La chronologie des secteurs étudiés permet d’embrasser un arc chronologique complet entre le XIIe et le VIe siécle av. J.-C., et donc d’appréhender les phénoménes évolutifs, tant en termes d’organisation générale qu’au niveau de l’espace interne et de l’architecture des habitations.

  15. Textbook of clinical trials

    National Research Council Canada - National Science Library

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

    2006-01-01

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

  16. Clinical trials in India.

    Science.gov (United States)

    Maiti, Rituparna; M, Raghavendra

    2007-07-01

    The concept of outsourcing for the development and global studies on new drugs has become widely accepted in the pharmaceutical industry due to its cost and uncertainty. India is going to be the most preferred location for contract pharma research and development due to its huge treatment naïve population, human resources, technical skills, adoption/amendment/implementation of rules/laws by regulatory authorities, and changing economic environment. But still 'miles to go' to fulfill the pre-requisites to ensure India's success. In spite of all the pitfalls, the country is ambitious and optimist to attract multinational pharmaceutical companies to conduct their clinical trials in India.

  17. Efficacy versus effectiveness trials : informing guidelines for asthma management

    NARCIS (Netherlands)

    Price, David; Hillyer, Elizabeth V.; van der Molen, Thys

    Purpose of review Randomized controlled trials, known as efficacy trials and long considered the gold standard for evidence-based asthma guidelines, are designed to test whether interventions have a benefit for selective patient populations under ideal conditions. The goal of pragmatic trials and

  18. Non-operative management of a complete anterior cruciate ligament injury in an English Premier League football player with return to play in less than 8 weeks: applying common sense in the absence of evidence

    Science.gov (United States)

    Weiler, Richard; Monte-Colombo, Mathew; Mitchell, Adam; Haddad, Fares

    2015-01-01

    This case report illustrates and discusses the non-operative management of a complete anterior cruciate ligament (ACL) injury in an English Premier League football player, his return to play within 8 weeks and problem-free follow-up at 18 months post injury. When non-operative verses surgical ACL reconstruction is considered there are many fundamental gaps in our knowledge and currently, at elite level, there are no cases in cutting sports within the literature to guide these decisions. When the norm is for all professional footballers to be recommended surgery, it will be very challenging when circumstances and patient autonomy dictate a conservative approach, where prognosis, end points and risk are unclear and assumed to be high. This case challenges current dogma and provides a starting point for much needed debate about best practice, treatment options, research direction and not just at the elite level of sport. PMID:25917066

  19. Bridging the gap between the randomised clinical trial world and the real world by combination of population-based registry and electronic health record data : A case study in haemato-oncology

    NARCIS (Netherlands)

    Kibbelaar, R E; Oortgiesen, B E; van der Wal-Oost, A M; Boslooper, K; Coebergh, J W; Veeger, N J G M; Joosten, P; Storm, H; van Roon, E N; Hoogendoorn, M

    2017-01-01

    Randomised clinical trials (RCTs) are considered the basis of evidence-based medicine. It is recognised more and more that application of RCT results in daily practice of clinical decision-making is limited because the RCT world does not correspond with the clinical real world. Recent strategies

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

    Science.gov (United States)

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

    2018-01-19

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