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Sample records for act trial experience

  1. Using process evaluation for program improvement in dose, fidelity and reach: the ACT trial experience

    Directory of Open Access Journals (Sweden)

    Kitzman-Ulrich Heather

    2009-11-01

    Full Text Available Abstract Background The purpose of this study was to demonstrate how formative program process evaluation was used to improve dose and fidelity of implementation, as well as reach of the intervention into the target population, in the "Active by Choice Today" (ACT randomized school-based trial from years 1 to 3 of implementation. Methods The intervention integrated constructs from Self-Determination Theory and Social Cognitive Theory to enhance intrinsic motivation and behavioral skills for increasing long-term physical activity (PA behavior in underserved adolescents (low income, minorities. ACT formative process data were examined at the end of each year to provide timely, corrective feedback to keep the intervention "on track". Results Between years 1 and 2 and years 2 and 3, three significant changes were made to attempt to increase dose and fidelity rates in the program delivery and participant attendance (reach. These changes included expanding the staff training, reformatting the intervention manual, and developing a tracking system for contacting parents of students who were not attending the after-school programs regularly. Process outcomes suggest that these efforts resulted in notable improvements in attendance, dose, and fidelity of intervention implementation from years 1 to 2 and 2 to 3 of the ACT trial. Conclusion Process evaluation methods, particularly implementation monitoring, are useful tools to ensure fidelity in intervention trials and for identifying key best practices for intervention delivery.

  2. [(68)Ga-labeled peptides for clinical trials - production according to the German Drug Act: the Göttingen experience].

    Science.gov (United States)

    Meller, Birgit; Angerstein, C; Liersch, T; Ghadimi, M; Sahlmann, C-O; Meller, J

    2012-01-01

    The AMG implies far-reaching implications for the synthesis of new radiopharmaceuticals for clinical trials. As a part of the DFG-funded Clinical Research Group (KFO 179) a project designated "Immuno-PET for assessment of early response to radiochemotherapy of advanced rectal cancer" was initiated. This trial is focused on a trivalent bispecific humanized monoclonal antibody, and a 68Ga-labeled peptide. Following the new regulatory framework we established a GMP-compliant cleanroom laboratory and applied for a manufacturing permission. During the project constructural, personnel and organizational conditions for a successful application were established, including a quality management system. A GMP-conform cleanroom laboratory class C was constructed, equipped with a two-chamber lock. The actual manufacturing is performed in a closed system with subsequent sterile filtration. The manufacturing processes have been automatised and validated as well as the necessary quality controls. The manufacturing permission was granted after an official inspection. The new German Drug Act is considered as a break in the production practice of nuclear medicine. The early involvement and communication with the authorities avoids time-consuming and costly planning errors. It is much to be hoped that the new legal situation in Germany will not cause serious impairments in the realization of clinical trials in German nuclear medicine.

  3. The Experiment as Act

    DEFF Research Database (Denmark)

    Søndergaard, Morten

    seminal experiments between poetry, sound and media. This paper will focus on the methodologies of ‘archiving’ experimental artforms. The ‘archive’, here, is argued to be in-between a gathering of objects and the simulation of time (Ernst). The archive presents one of the great cultural enigmas of our......In December 1965, an experiment took place at The Independent Art Space in Copenhagen (Den Frie Kunstbygning). Short named POEX65, it was looking to create and activate POetry EXperiments across artistic genres and formats (thus, in essence, making a POetry EXposition). The POEX65 event framed many...... time: It is constructed like a (sub)medium that collects our cultural history; at the same time, the archive often ‘forgets’ it’s own pre-experimental status and simply slips into a state of unconscious repetition which allows parallel histories to emerge in-between everything else. This paper tries...

  4. Experiences from an ACT programme in Copenhagen

    DEFF Research Database (Denmark)

    Benjaminsen, Lars

    , and social workers with administrative authority from the social office and the job center. In the international research literature ACT has been shown in randomized controlled trials to be a very effective method in bringing individuals out of homelessness and into a stable housing situation. This study...... units are well described in the research literature. All in all the study shows that ACT is a very effective method of supporting homeless individuals with complex needs to move into own housing and to remain housed. Especially, the study shows that with the support from an ACT-team it is possible......This working paper presents intermediary results of a study of an ACT-program (Assertive Community Treatment) in Copenhagen, Denmark. The ACT-program is aimed at rehousing homeless individuals and providing floating support in the citizens own home from a multidisciplinary support team. The target...

  5. Experiences from an ACT programme in Copenhagen

    DEFF Research Database (Denmark)

    Benjaminsen, Lars

    This working paper presents intermediary results of a study of an ACT-program (Assertive Community Treatment) in Copenhagen, Denmark. The ACT-program is aimed at rehousing homeless individuals and providing floating support in the citizens own home from a multidisciplinary support team. The target...... groups of ACT are individuals who have complex support needs due to for instance mental illness and/or substance abuse and for whom it is difficult to use mainstream support systems. The team consists not only of social support workers but also of a psychiatrist, a nurse and an addiction councilor......, and social workers with administrative authority from the social office and the job center. In the international research literature ACT has been shown in randomized controlled trials to be a very effective method in bringing individuals out of homelessness and into a stable housing situation. This study...

  6. Profiling Language Skills. Trialing the Languages Profile in the ACT.

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    Liddicoat, Anthony J.

    1998-01-01

    The Australian Capital Territory (ACT) National Professional Development Program helped language teachers familiarize themselves with the Languages Profile and collect and annotate work samples using the Profile. Their experiences become the basis for disseminating information among ACT language teachers. The paper presents recurrent issues raised…

  7. Long-acting reversible contraceptive acceptability and unintended pregnancy among women presenting for short-acting methods: a randomized patient preference trial.

    Science.gov (United States)

    Hubacher, David; Spector, Hannah; Monteith, Charles; Chen, Pai-Lien; Hart, Catherine

    2017-02-01

    Measures of contraceptive effectiveness combine technology and user-related factors. Observational studies show higher effectiveness of long-acting reversible contraception compared with short-acting reversible contraception. Women who choose long-acting reversible contraception may differ in key ways from women who choose short-acting reversible contraception, and it may be these differences that are responsible for the high effectiveness of long-acting reversible contraception. Wider use of long-acting reversible contraception is recommended, but scientific evidence of acceptability and successful use is lacking in a population that typically opts for short-acting methods. The objective of the study was to reduce bias in measuring contraceptive effectiveness and better isolate the independent role that long-acting reversible contraception has in preventing unintended pregnancy relative to short-acting reversible contraception. We conducted a partially randomized patient preference trial and recruited women aged 18-29 years who were seeking a short-acting method (pills or injectable). Participants who agreed to randomization were assigned to 1 of 2 categories: long-acting reversible contraception or short-acting reversible contraception. Women who declined randomization but agreed to follow-up in the observational cohort chose their preferred method. Under randomization, participants chose a specific method in the category and received it for free, whereas participants in the preference cohort paid for the contraception in their usual fashion. Participants were followed up prospectively to measure primary outcomes of method continuation and unintended pregnancy at 12 months. Kaplan-Meier techniques were used to estimate method continuation probabilities. Intent-to-treat principles were applied after method initiation for comparing incidence of unintended pregnancy. We also measured acceptability in terms of level of happiness with the products. Of the 916

  8. How do parents experience being asked to enter a child in a randomised controlled trial?

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    Young Bridget

    2009-02-01

    Full Text Available Abstract Background As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enrol their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words. Discussion Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual pants will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make. Summary Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future

  9. Advanced Communication Technology Satellite (ACTS) multibeam antenna technology verification experiments

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    Acosta, Roberto J.; Larko, Jeffrey M.; Lagin, Alan R.

    1992-01-01

    The Advanced Communication Technology Satellite (ACTS) is a key to reaching NASA's goal of developing high-risk, advanced communications technology using multiple frequency bands to support the nation's future communication needs. Using the multiple, dynamic hopping spot beams, and advanced on board switching and processing systems, ACTS will open a new era in communications satellite technology. One of the key technologies to be validated as part of the ACTS program is the multibeam antenna with rapidly reconfigurable hopping and fixed spot beam to serve users equipped with small-aperature terminals within the coverage areas. The proposed antenna technology experiments are designed to evaluate in-orbit ACTS multibeam antenna performance (radiation pattern, gain, cross pol levels, etc.).

  10. Insurance denials for cancer clinical trial participation after the Affordable Care Act mandate.

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    Mackay, Christine B; Antonelli, Kaitlyn R; Bruinooge, Suanna S; Saint Onge, Jarron M; Ellis, Shellie D

    2017-08-01

    The Affordable Care Act (ACA) includes a mandate requiring most private health insurers to cover routine patient care costs for cancer clinical trial participation; however, the impact of this provision on cancer centers' efforts to accrue patients to clinical trials has not been well described. First, members of cancer research centers and community-based institutions (n = 252) were surveyed to assess the status of insurance denials, and then, a focused survey (n = 77) collected denial details. Univariate and multivariate analyses were used to examine associations between the receipt of denials and site characteristics. Overall, 62.7% of the initial survey respondents reported at least 1 insurance denial during 2014. Sites using a precertification process were 3.04 times more likely to experience denials (95% confidence interval, 1.55-5.99; P ≤ .001), and similar rates of denials were reported from sites located in states with preexisting clinical trial coverage laws versus states without them (82.3% vs 85.1%; χ = 50.7; P ≤ .001). Among the focused survey sites, academic centers reported denials more often than community sites (71.4% vs 46.4%). The failure of plans to cover trial participation was cited as the most common reason provided for denials (n = 33 [80.5%]), with nearly 80% of sites (n = 61) not receiving a coverage response from the insurer within 72 hours. Despite the ACA's mandate for most insurers to cover routine care costs for cancer clinical trial participation, denials and delays continue. Denials may continue because some insurers remain exempt from the law, or they may signal an implementation failure. Delays in coverage may affect patient participation in trials. Additional efforts to eliminate this barrier will be needed to achieve federal initiatives to double the pace of cancer research over the next 5 years. Future work should assess the law's effectiveness at the patient level to inform these efforts

  11. Physician and patient benefit–risk preferences from two randomized long-acting injectable antipsychotic trials

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    Katz, Eva G; Hauber, Brett; Gopal, Srihari; Fairchild, Angie; Pugh, Amy; Weinstein, Rachel B; Levitan, Bennett S

    2016-01-01

    Purpose To quantify clinical trial participants’ and investigators’ judgments with respect to the relative importance of efficacy and safety attributes of antipsychotic treatments for schizophrenia, and to assess the impact of formulation and adherence. Methods Discrete-choice experiment surveys were completed by patients with schizophrenia and physician investigators participating in two phase-3 clinical trials of paliperidone palmitate 3-month long-acting injectable (LAI) antipsychotic. Respondents were asked to choose between hypothetical antipsychotic profiles defined by efficacy, safety, and mode of administration. Data were analyzed using random-parameters logit and probit models. Results Patients (N=214) and physicians (N=438) preferred complete improvement in positive symptoms (severe to none) as the most important attribute, compared with improvement in any other attribute studied. Both respondents preferred 3-month and 1-month injectables to oral formulation (P30%. For patients, adherent: 10.1% (95% CI: 6.1–14.1), nonadherent: the change in efficacy studied was regarded as unimportant. Conclusion Improvement in positive symptoms was the most important attribute. Patients and physicians preferred LAIs over oral antipsychotics, with physicians showing a greater preference for 3-month over 1-month LAI. Physicians and patients were willing to accept reduced efficacy in exchange for switching a patient from an oral formulation to a LAI.

  12. Physician and patient benefit–risk preferences from two randomized long-acting injectable antipsychotic trials

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    Katz EG

    2016-10-01

    Full Text Available Eva G Katz,1 Brett Hauber,2 Srihari Gopal,3 Angie Fairchild,2 Amy Pugh,4 Rachel B Weinstein,3 Bennett S Levitan3 1Janssen Research & Development, LLC, Raritan, NJ, 2RTI Health Solutions, Research Triangle Park, NC, 3Janssen Research & Development, LLC, Titusville, NJ, 4The University of California, San Francisco (UCSF, CA, USA Purpose: To quantify clinical trial participants’ and investigators’ judgments with respect to the relative importance of efficacy and safety attributes of antipsychotic treatments for schizophrenia, and to assess the impact of formulation and adherence.Methods: Discrete-choice experiment surveys were completed by patients with schizophrenia and physician investigators participating in two phase-3 clinical trials of paliperidone palmitate 3-month long-acting injectable (LAI antipsychotic. Respondents were asked to choose between hypothetical antipsychotic profiles defined by efficacy, safety, and mode of administration. Data were analyzed using random-parameters logit and probit models.Results: Patients (N=214 and physicians (N=438 preferred complete improvement in positive symptoms (severe to none as the most important attribute, compared with improvement in any other attribute studied. Both respondents preferred 3-month and 1-month injectables to oral formulation (P<0.05, irrespective of prior adherence to oral antipsychotic treatment, with physicians showing greater preference for a 3-month over a 1-month LAI for nonadherent patients. Physicians were willing to accept treatments with reduced efficacy for patients with prior poor adherence. The maximum decrease in efficacy (95% confidence interval [CI] that physicians would accept for switching a patient from daily oral to 3-month injectable was as follows: adherent: 9.8% (95% CI: 7.2–12.4, 20% nonadherent: 25.4% (95% CI: 21.0–29.9, and 50% nonadherent: >30%. For patients, adherent: 10.1% (95% CI: 6.1–14.1, nonadherent: the change in efficacy studied was

  13. Clinical trial participants’ experiences of completing questionnaires: a qualitative study

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    Holmberg, Christine; Karner, Julia J; Rappenecker, Julia; Witt, Claudia M

    2014-01-01

    Objectives To improve clinical study developments for elderly populations, we aim to understand how they transfer their experiences into validated, standardised self-completed study measurement instruments. We analysed how women (mean 78±8 years of age) participating in a randomised controlled trial (RCT) cognised study instruments used to evaluate outcomes of the intervention. Setting The interview study was nested in an RCT on chronic neck pain using common measurement instruments situated in an elderly community in Berlin, Germany, which comprised of units for independent and assisted-living options. Participants The sample (n=20 women) was selected from the RCT sample (n=117, 95% women, mean age 76 (SD±8) years). Interview participants were selected using a purposive sampling list based on the RCT outcomes. Outcomes We asked participants about their experiences completing the RCT questionnaires. Interviews were analysed thematically, then compared with the questionnaires. Results Interviewees had difficulties in translating complex experiences into a single value on a scale and understanding the relationship of the questionnaires to study aims. Interviewees considered important for the trial that their actual experiences were understood by trial organisers. This information was not transferrable by means of the questionnaires. To rectify these difficulties, interviewees used strategies such as adding notes, adding response categories or skipping an item. Conclusions Elderly interview participants understood the importance of completing questionnaires for trial success. This led to strategies of completing the questionnaires that resulted in ‘missing’ or ambiguous data. To improve data collection in elderly populations, educational materials addressing the differential logics should be developed and tested. Pilot testing validated instruments using cognitive interviews may be particularly important in such populations. Finally, when the target of an

  14. Design of the Xylitol for Adult Caries Trial (X-ACT

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    Amaechi Bennett T

    2010-09-01

    Full Text Available Abstract Background Dental caries incidence in adults is similar to that in children and adolescents, but few caries preventive agents have been evaluated for effectiveness in adults populations. In addition, dentists direct fewer preventive services to their adult patients. Xylitol, an over-the-counter sweetener, has shown some potential as a caries preventive agent, but the evidence for its effectiveness is not yet conclusive and is based largely on studies in child populations. Methods/Design X-ACT is a three-year, multi-center, placebo controlled, double-blind, randomized clinical trial that tests the effects of daily use of xylitol lozenges versus placebo lozenges on the prevention of adult caries. The trial has randomized 691 participants (ages 21-80 to the two arms. The primary outcome is the increment of cavitated lesions. Discussion This trial should help resolve the overall issue of the effectiveness of xylitol in preventing caries by contributing evidence with a low risk of bias. Just as importantly, the trial will provide much-needed information about the effectiveness of a promising caries prevention agent in adults. An effective xylitol-based caries prevention intervention would represent an easily disseminated method to extend caries prevention to individuals not receiving caries preventive treatment in the dental office. Trial Registration ClinicalTrials.Gov NCT00393055

  15. Clinical trial participants' experiences of completing questionnaires: a qualitative study.

    Science.gov (United States)

    Holmberg, Christine; Karner, Julia J; Rappenecker, Julia; Witt, Claudia M

    2014-03-24

    To improve clinical study developments for elderly populations, we aim to understand how they transfer their experiences into validated, standardised self-completed study measurement instruments. We analysed how women (mean 78±8 years of age) participating in a randomised controlled trial (RCT) cognised study instruments used to evaluate outcomes of the intervention. The interview study was nested in an RCT on chronic neck pain using common measurement instruments situated in an elderly community in Berlin, Germany, which comprised of units for independent and assisted-living options. The sample (n=20 women) was selected from the RCT sample (n=117, 95% women, mean age 76 (SD±8) years). Interview participants were selected using a purposive sampling list based on the RCT outcomes. We asked participants about their experiences completing the RCT questionnaires. Interviews were analysed thematically, then compared with the questionnaires. Interviewees had difficulties in translating complex experiences into a single value on a scale and understanding the relationship of the questionnaires to study aims. Interviewees considered important for the trial that their actual experiences were understood by trial organisers. This information was not transferrable by means of the questionnaires. To rectify these difficulties, interviewees used strategies such as adding notes, adding response categories or skipping an item. Elderly interview participants understood the importance of completing questionnaires for trial success. This led to strategies of completing the questionnaires that resulted in 'missing' or ambiguous data. To improve data collection in elderly populations, educational materials addressing the differential logics should be developed and tested. Pilot testing validated instruments using cognitive interviews may be particularly important in such populations. Finally, when the target of an intervention is a subjective experience, it seems important to create a

  16. The Anticoagulation of Calf Thrombosis (ACT project: study protocol for a randomized controlled trial

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    Horner Daniel

    2012-04-01

    Full Text Available Abstract Background Half of all lower limb deep vein thrombi (DVT in symptomatic ambulatory patients are located in the distal (calf veins. While proximal disease warrants therapeutic anticoagulation to reduce the associated risks, distal DVT often goes untreated. However, a proportion of untreated distal disease will undoubtedly propagate or embolize. Concern also exists that untreated disease could lead to long-term post thrombotic changes. Currently, it is not possible to predict which distal thrombi will develop such complications. Whether these potential risks outweigh those associated with unrestricted anticoagulation remains unclear. The Anticoagulation of Calf Thrombosis (ACT trial aims to compare therapeutic anticoagulation against conservative management for patients with acute symptomatic distal deep vein thrombosis. Methods ACT is a pragmatic, open-label, randomized controlled trial. Adult patients diagnosed with acute distal DVT will be allocated to either therapeutic anticoagulation or conservative management. All patients will undergo 3 months of clinical and assessor blinded sonographic follow-up, followed by 2-year final review. The project will commence initially as an external pilot study, recruiting over a 16-month period at a single center to assess feasibility measures and clinical event rates. Primary outcome measures will assess feasibility endpoints. Secondary clinical outcomes will be collected to gather accurate data for the design of a definitive clinical trial and will include: (1 a composite endpoint combining thrombus propagation to the popliteal vein or above, development of symptomatic pulmonary embolism or sudden death attributable to venous thromboembolic disease; (2 the incidence of major and minor bleeding episodes; (3 the incidence of post-thrombotic leg syndrome at 2 years using a validated screening tool; and (4 the incidence of venous thromboembolism (VTE recurrence at 2 years. Discussion The ACT trial

  17. [Defining trials of medicinal products according to the revised Dutch Medical Research in Human Subjects Act (WMO)].

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    Vos, E J; Huitema, A D R

    2006-09-23

    The revised Dutch Medical Research in Human Subjects Act (WMO), which implements the European directive regarding 'good clinical practice in the conduct of clinical trials on medicinal products for human use' (2001/20/EC), became effective on March 1, 2006. The revision places additional requirements on trials of medicinal products. Whether a trial should be regarded as a trial of a medicinal product is therefore an important question. The law does not provide adequate guidance for the classification of trials in which biological samples are collected, e.g. for genomic, proteomic or pharmacokinetic studies, while a medicinal product is given for a registered indication. Classifying these types of trials as trials of medicinal products does not enhance the safety of the participants. Therefore, these studies should not be considered as trials of medicinal products to avoid the increased administrative burden required by the revised WMO.

  18. The European "clinical trial" regulation; relationship with the Jardé Act: a Giens workshop.

    Science.gov (United States)

    Lemaire, François; Marchenay, Brigitte; Chassany, Olivier; Barthélémy, Philippe; Bouzzagou, Mohamed; Comet, Denis; Delval, Cécile; Dubray, Claude; Fouret, Cécile; Frija-Orvoen, Elisabeth; Gambotti, Laetitia; Lamarque, Véronique; d'Orsay, Geneviève; Plattner, Valérie; Sibenaler, Claire; Roux, Jacques; Thoby, Frédérique

    2015-01-01

    In May 2014, the European Union Parliament and Council published a new regulation on clinical trials on medicinal products for human use, which is designed to replace Directive 2001/20/EC. It will not come into effect until 2016. Nevertheless, it is essential to examine its relationship with national legislation, i.e. the Jardé Act, whose implementation has been delayed pending publication of the European regulation. The Giens workshop identified and examined the various issues that this relationship is bound to raise. In particular, it looked at trial methodology assessment procedures, the working relationship between the French National Agency of Drug Safety and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM) and ethics committees during the authorization application evaluation phase, review of post-authorization/registration studies on medicinal products and medical devices, and data transparency.

  19. A randomised controlled trial of acceptance and commitment therapy (ACT) for psychosis: study protocol.

    Science.gov (United States)

    Thomas, Neil; Shawyer, Frances; Castle, David J; Copolov, David; Hayes, Steven C; Farhall, John

    2014-07-11

    Cognitive behavior therapy for psychosis has been a prominent intervention in the psychological treatment of psychosis. It is, however, a challenging therapy to deliver and, in the context of increasingly rigorous trials, recent reviews have tempered initial enthusiasm about its effectiveness in improving clinical outcomes. Acceptance and commitment therapy shows promise as a briefer, more easily implemented therapy but has not yet been rigorously evaluated in the context of psychosis. The purpose of this trial is to evaluate whether Acceptance and Commitment Therapy could reduce the distress and disability associated with psychotic symptoms in a sample of community-residing patients with chronic medication-resistant symptoms. This is a single (rater)-blind multi-centre randomised controlled trial comparing Acceptance and Commitment Therapy with an active comparison condition, Befriending. Eligible participants have current residual hallucinations or delusions with associated distress or disability which have been present continuously over the past six months despite therapeutic doses of antipsychotic medication. Following baseline assessment, participants are randomly allocated to treatment condition with blinded, post-treatment assessments conducted at the end of treatment and at 6 months follow-up. The primary outcome is overall mental state as measured using the Positive and Negative Syndrome Scale. Secondary outcomes include preoccupation, conviction, distress and disruption to life associated with symptoms as measured by the Psychotic Symptom Rating Scales, as well as social functioning and service utilisation. The main analyses will be by intention-to-treat using mixed-model repeated measures with non-parametric methods employed if required. The model of change underpinning ACT will be tested using mediation analyses. This protocol describes the first randomised controlled trial of Acceptance and commitment therapy in chronic medication-resistant psychosis

  20. The influence of vocal training and acting experience on measures of voice quality and emotional genuineness

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    Steven Robert Livingstone

    2014-03-01

    Full Text Available Vocal training through singing and acting lessons is known to modify acoustic parameters of the voice. While the effects of singing training have been well documented, the role of acting experience on the singing voice remains unclear. In two experiments, we used linear mixed models to examine the relationships between the relative amounts of acting and singing experience on the acoustics and perception of the male singing voice. In Experiment 1, twelve male vocalists were recorded while singing with five different emotions, each with two intensities. Acoustic measures of pitch accuracy, jitter, and harmonics-to-noise (HNR ratio were examined. Decreased pitch accuracy and increased jitter, indicative of a lower ‘voice quality’, were associated with more years of acting experience, while increased pitch accuracy was associated with more years of singing lessons. We hypothesized that the acoustic deviations exhibited by more experienced actors was an intentional technique to increase the genuineness or truthfulness of their emotional expressions. In Experiment 2, listeners rated vocalists’ emotional genuineness. Vocalists with more years of acting experience were rated as more genuine than vocalists with less acting experience. No relationship was reported for singing training. Increased genuineness was associated with decreased pitch accuracy, increased jitter, and a higher harmonics-to-noise ratio. These effects may represent a shifting of priorities by male vocalists with acting experience to emphasize emotional genuineness over pitch accuracy or voice quality in their singing performances.

  1. The Anti-Clot Treatment Scale (ACTS in clinical trials: cross-cultural validation in venous thromboembolism patients

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    Cano Stefan J

    2012-09-01

    Full Text Available Abstract Background The Anti-Clot Treatment Scale (ACTS is a 15-item patient-reported instrument of satisfaction with anticoagulant treatment. It includes a 12-item ACTS Burdens scale and a 3-item ACTS Benefits scale. Its role in clinical trials and other settings should be supported by evidence that it is both clinically meaningful and scientifically sound. The aim of the study was to evaluate the measurement performance of the ACTS (Dutch, Italian, French, German and English language versions in patients with venous thromboembolism based on traditional psychometric methods. Methods ACTS Burdens and Benefits scale data from a large clinical trial (EINSTEIN DVT involving 1336 people with venous thromboembolism were analysed at both the scale and item level. Five key psychometric properties were examined using traditional psychometric methods: acceptability, scaling assumptions, reliability (including internal consistency reliability, test-retest reproducibility; validity (including known groups and discriminant validity; and responsiveness. These methods of examination underpin the US Food and Drug Administration recommendations for patient-reported outcome instrument evaluation. Results Overall, the 12-item ACTS Burdens scale and 3-item ACTS Benefits scale met the psychometric criteria evaluated at both item and scale levels, with the exception of some relatively minor issues in the Dutch language version, which were just below reliability criteria (i.e. alpha = 0.72, test-retest intraclass correlation = 0.79. A consistent finding from item-level evaluations of aggregate endorsement frequencies and skewness suggested that response scales may be improved by reducing the number of response options from five to four. Conclusions Both the ACTS Burdens and ACTS Benefits scales consistently satisfied traditional reliability and validity criteria across multiple language datasets, supporting it as a clinically useful patient

  2. Increasing valued behaviors precedes reduction in suffering: Findings from a randomized controlled trial using ACT.

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    Gloster, Andrew T; Klotsche, Jens; Ciarrochi, Joseph; Eifert, Georg; Sonntag, Rainer; Wittchen, Hans-Ulrich; Hoyer, Jürgen

    2017-04-01

    Psychological flexibility theory (PFT) suggests three key processes of change: increases in value-directed behaviors, reduction in struggle with symptoms, and reduction in suffering. We hypothesized that Acceptance and Commitment Therapy (ACT) would change these processes and that increases in valued action and decreases in struggle would precede change in suffering. Data were derived from a randomized clinical trial testing ACT (vs. waitlist) for treatment-resistant patients with primary panic disorder with/without agoraphobia (n = 41). Valued behavior, struggle, and suffering were assessed at each of eight sessions. Valued actions, struggle, and suffering all changed over the course of therapy. Overall changes in struggle and suffering were interdependent whereas changes in valued behavior were largely independent. Levels of valued behaviors influenced subsequent suffering, but the other two variables did not influence subsequent levels of valued action. This finding supports a central tenet of PFT that increased (re-)engagement in valued behaviors precedes reductions in suffering. Possible implications for a better understanding of response and non-response to psychotherapy are discussed. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. Drawing and acting as user experience research tools

    DEFF Research Database (Denmark)

    Fleury, Alexandre

    2012-01-01

    This paper discusses the use of participant-generated drawings and drama workshops as user experience research methods. In spite of the lack of background literature on how drawings can generate useful insights on HCI issues, drawings have been successfully used in other research fields. On the c...... during the three case studies is very encouraging and calls for additional reports of UX evaluations involving drawing- and theatre-based exercises....

  4. Design and implementation of an experiment scheduling system for the ACTS satellite

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    Ringer, Mark J.

    1994-01-01

    The Advanced Communication Technology Satellite (ACTS) was launched on the 12th of September 1993 aboard STS-51. All events since that time have proceeded as planned with user operations commencing on December 6th, 1993. ACTS is a geosynchronous satellite designed to extend the state of the art in communication satellite design and is available to experimenters on a 'time/bandwidth available' basis. The ACTS satellite requires the advance scheduling of experimental activities based upon a complex set of resource, state, and activity constraints in order to ensure smooth operations. This paper describes the software system developed to schedule experiments for ACTS.

  5. Paul’s ecstatic trance experience near Damascus in Acts of the Apostles

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    John J. Pilch

    2002-11-01

    Full Text Available Luke reports more than twenty altered states of consciousness experiences in Acts of the Apostles. These  are common and normal human experiences in approximately ninety percent of contemporary cultures.    In the ancient Circum-Mediterranean world, it seems to have been common and normal in about eighty percent  of  those  cultures. Insights from psychological anthropology, cultural anthropology and cognitive neuroscience contribute to an improved understanding and interpretation of these experiences in the Bible, particularly the call of Paul as reported in Acts 9; 22; 26.

  6. Establishing a clinical trials network in nephrology: experience of the Australasian Kidney Trials Network.

    Science.gov (United States)

    Morrish, Alicia T; Hawley, Carmel M; Johnson, David W; Badve, Sunil V; Perkovic, Vlado; Reidlinger, Donna M; Cass, Alan

    2014-01-01

    Chronic kidney disease is a major public health problem globally. Despite this, there are fewer high-quality, high-impact clinical trials in nephrology than other internal medicine specialties, which has led to large gaps in evidence. To address this deficiency, the Australasian Kidney Trials Network, a Collaborative Research Group, was formed in 2005. Since then, the Network has provided infrastructure and expertise to conduct patient-focused high-quality, investigator-initiated clinical trials in nephrology. The Network has not only been successful in engaging the nephrology community in Australia and New Zealand but also in forming collaborations with leading researchers from other countries. This article describes the establishment, development, and functions of the Network. The article also discusses the current and future funding strategies to ensure uninterrupted conduct of much needed clinical trials in nephrology to improve the outcomes of patients affected by kidney diseases with cost-effective interventions.

  7. Clinical Experience amongst Surgeons in the Asymptomatic Carotid Surgery Trial-1

    NARCIS (Netherlands)

    Huibers, Anne; de Waard, Djurre; Bulbulia, Richard; de Borst, Gert Jan; Halliday, Alison

    2016-01-01

    INTRODUCTION: Hospital volume may influence the outcomes of carotid revascularization, but in trials the effect of the clinical experience of individual surgeons on procedural outcome is less certain. We assessed perioperative event rates amongst centers with different trial entry volumes and also t

  8. The mediated live experience and the spatial reconfiguration of the sport act

    Directory of Open Access Journals (Sweden)

    Diana Luiza Dumitriu

    2016-04-01

    Full Text Available The media-sport relation of interdependency has influenced both the commodity value of sport actors and events, as well as the mere sport experience. The present study focuses on the reconfiguration process of the spectatorship experience through media, addressing two of its central dimensions: the emotional and physical one. Along with the wide accessibility to sport events and a progressive grow of audiences, media provided a mediated live experience that ended up competing with the genuine live experience. Strongly related and dependent on the technological changes and the dynamics of the globalization process, media went beyond simply transmitting the sport event, engaging in a process of redefining it. In doing so, they generated a deterritorialized laboratory sport experience, “hotting-up” the spectatorship experience and minimizing the perceptual constrains. This, in turn, ended up by making this media-sport hyperreality more appealing than the genuine live experience of sport acts. In addressing the spatial reconfiguration of the spectatorship experience, I have built up a new model in order to better respond to the primacy of connectivity over the space-dependent experience of sport acts: the scattering model of sport spectatorship. Moreover, I discuss the mixture of the private and public zones as a strategic way of maximizing the accessibility and customization of sport media-products, inside the wider process of sport commodification.

  9. The Impact of CBT and ACT Models Using Psychology Trainee Therapists: A Preliminary Controlled Effectiveness Trial

    Science.gov (United States)

    Lappalainen, Raimo; Lehtonen, Tuula; Skarp, Eerika; Taubert, Eija; Ojanen, Markku; Hayes, Steven C.

    2007-01-01

    The present study compares the impact of individualized treatment provided by trainee therapists based on a traditional cognitive behavior therapy (CBT) and acceptance and commitment therapy (ACT) model. Fourteen therapists were given initial training in CBT and ACT. Outpatients (N = 28) were randomized to either approach, with each therapist…

  10. Selection and utilization of assessment instruments in substance abuse treatment trials: the National Drug Abuse Treatment Clinical Trials Network experience

    Directory of Open Access Journals (Sweden)

    Rosa C

    2012-07-01

    Full Text Available Carmen Rosa, Udi Ghitza, Betty TaiCenter for the Clinical Trials Network, National Institute on Drug Abuse, Bethesda, MD, USAAbstract: Based on recommendations from a US Institute of Medicine report, the National Institute on Drug Abuse established the National Drug Abuse Treatment Clinical Trials Network (CTN in 1999, to accelerate the translation of science-based addiction treatment research into community-based practice, and to improve the quality of addiction treatment, using science as the vehicle. One of the CTN's primary tasks is to serve as a platform to forge bi-directional communications and collaborations between providers and scientists, to enhance the relevance of research, which generates empirical results that impact practice. Among many obstacles in moving research into real-world settings, this commentary mainly describes challenges and iterative experiences in regard to how the CTN develops its research protocols, with focus on how the CTN study teams select and utilize assessment instruments, which can reasonably balance the interests of both research scientists and practicing providers when applied in CTN trials. This commentary also discusses the process by which the CTN further selects a core set of common assessment instruments that may be applied across all trials, to allow easier cross-study analyses of comparable data.Keywords: addiction, assessment, drug abuse treatment, drug dependence, NIDA Clinical Trials Network, substance use disorder

  11. Emotional Labor: The Role of Employee Acting Strategies on Customer Emotional Experience and Subsequent Buying Decisions

    OpenAIRE

    Chaoying Tang; Seal, Craig R.; Stefanie E. Naumann; Krystal Miguel

    2013-01-01

    Prior research has demonstrated the impact of employee emotional labor strategies (deep and surface acting) on customer behavioral intentions. However, there is limited data on the impact of emotional labor strategy on potential intervening variables and on actual buying decisions. This study extends the prior research by examining the effect of employee emotional labor strategies on customers’ emotional experiences and actual customer purchasing decisions. Data were collected from 294 employ...

  12. Oregon's Death With Dignity Act: 20 Years of Experience to Inform the Debate.

    Science.gov (United States)

    Hedberg, Katrina; New, Craig

    2017-09-19

    Twenty years ago, Oregon voters approved the Death With Dignity Act, making Oregon the first state in the United States to allow physicians to prescribe medications to be self-administered by terminally ill patients to hasten their death. This report summarizes the experience in Oregon, including the numbers and types of participating patients and providers. These data should inform the ongoing policy debate as additional jurisdictions consider such legislation.

  13. Special features of health services and register based trialsexperiences from a randomized trial of childbirth classes

    Directory of Open Access Journals (Sweden)

    Sevón Tiina

    2008-06-01

    Full Text Available Abstract Background Evaluating complex interventions in health services faces various difficulties, such as making practice changes and costs. Ways to increase research capacity and decrease costs include making research an integral part of health services and using routine data to judge outcomes. The purpose of this article is to report the feasibility of a pilot trial relying solely on routinely collected register data and being based on ordinary health services. Methods The example intervention was education to public health nurses (PHN (childbirth classes to reduce caesarean section rates via pre-delivery considerations of pregnant women. 20 maternity health centers (MHC were paired and of each 10 pairs, one MHC was randomly allocated to an intervention group and the other to a control; 8 pairs with successful intervention were used in the analyses (1601 mothers. The women visiting to the study maternity centers were identified from the Customer Register of Helsinki City. A list of the study women was made using the mother's personal identification number, visit date, the maternity center code, birth date and gestation length. The mode of delivery and health outcomes were retrieved from the Finnish Medical Birth Register (MBR. Process data of the intervention are based on observations, written feedback and questionnaires from PHNs, and project correspondence. Results It took almost two years to establish how to obtain permissions and to actually obtain it for the trial. Obtaining permissions for the customer and outcome data and register linkages was unproblematic and the cluster randomization provided comparable groups. The intervention did not succeed well. Had the main aim of the trial been to cause a change in PHNs behavior, we would have very likely intensified the intervention during the trial. Conclusion Our experiences encourage the use of trials that obtain their outcomes from registers. Changing the behavior of ordinary health

  14. EMOTIONAL LABOR: THE ROLE OF EMPLOYEE ACTING STRATEGIES ON CUSTOMER EMOTIONAL EXPERIENCE AND SUBSEQUENT BUYING DECISIONS

    Directory of Open Access Journals (Sweden)

    Chaoying Tang

    2013-01-01

    Full Text Available Prior research has demonstrated the impact of employee emotional labor strategies (deep and surface acting on customer behavioral intentions. However, there is limited data on the impact of emotional labor strategy on potential intervening variables and on actual buying decisions. This study extends the prior research by examining the effect of employee emotional labor strategies on customers’ emotional experiences and actual customer purchasing decisions. Data were collected from 294 employee-customer pairs from retail cell phone stores in China. Results indicated that choice of strategy (deep or surface does significantly impact purchase decisions. In addition, the relationship between strategy and purchase is mediated by the customer's emotional experience.

  15. Acceptance and commitment group therapy (ACT-G) for health anxiety: a randomized controlled trial.

    Science.gov (United States)

    Eilenberg, T; Fink, P; Jensen, J S; Rief, W; Frostholm, L

    2016-01-01

    Severe health anxiety is frequent and costly, yet rarely diagnosed or treated. Earlier treatment studies show problems with recruitment, dropout and recovery. In the current study, the authors aimed to test the effect of acceptance and commitment group therapy (ACT-G) compared to waitlist in patients with severe health anxiety. During March 2010 to April 2012, 126 consecutively referred patients meeting research criteria for severe health anxiety were block-randomized (1:1) to ACT-G or a 10 months' waitlist (Clinicaltrials.gov, no. NCT01158430). Patients allocated to ACT-G were treated in seven groups of nine patients between December 2010 and October 2012 and received nine weekly 3-h group sessions and a booster session consisting of ACT techniques. The primary outcome was decided a priori as the mean change in self-reported illness worry on the Whiteley-7 Index (WI) from baseline to 10 months' follow-up. Secondary outcomes were improvement in emotional distress and health-related quality of life at 10 months' follow-up. Intention-to-treat analysis showed a statistically significant mean difference of 20.5 points [95% confidence interval (CI) 11.7-29.4, p accepted by the patients. ACT-G seems feasible, acceptable and effective in treating severe health anxiety.

  16. Comparison of treatment effects between animal experiments and clinical trials: systematic review

    OpenAIRE

    2006-01-01

    Objective To examine concordance between treatment effects in animal experiments and clinical trials.Study design Systematic review.Data sources Medline, Embase, SIGLE, NTIS, Science Citation Index, CAB, BIOSIS.Study selection Animal studies for interventions with unambiguous evidence of a treatment effect (benefit or harm) in clinical trials: head injury, antifibrinolytics in haemorrhage, thrombolysis in acute ischaemic stroke, tirilazad in acute ischaemic stroke, antenatal corticosteroids t...

  17. Acceptance and commitment therapy for adults with advanced cancer (CanACT): study protocol for a feasibility randomised controlled trial.

    Science.gov (United States)

    Low, Joseph; Serfaty, Marc; Davis, Sarah; Vickerstaff, Victoria; Gola, Anna; Omar, Rumana Z; King, Michael; Tookman, Adrian; Austen, Janet St John; Turner, Karen; Jones, Louise

    2016-02-11

    One-third of people with cancer experience psychological distress and may suppress distressing thoughts, emotions, and concerns, leading to further problems. Conventional psychological treatments reduce distress by problem solving, but in advanced cancer, when ill health is progressive and death may be approaching, physical and psychological difficulties are complex and have no simple solutions. Acceptance and Commitment Therapy encourages acknowledgement and acceptance of mental experiences, increasing people's ability to work with problems that cannot be solved. Previous pilot work in advanced cancer confirms that distress can be associated with an avoidance of experiencing uncomfortable thoughts and emotions. This feasibility randomised controlled trial of Acceptance Commitment Therapy aims to establish parameters for a larger trial. Fifty-four participants with advanced cancer will be randomly allocated to up to eight sessions (each 1 hour) of Acceptance Commitment Therapy or a talking control. Participants will be recruited from those attending outpatient services and hospice day care at three specialist palliative care units in North and East London, United Kingdom. The primary outcome is a measure of functioning in four areas of life (physical, social/family, emotional, and general activity) using the Functional Assessment of Cancer Therapies--General questionnaire at 3 months after randomisation. Secondary outcomes are (i) acceptance using the Acceptance and Action Questionnaire; (ii) psychological distress using the Kessler Psychological Distress Scale; (iii) physical functioning using a timed walk and sit-to-stand test; and (iv) quality of life measures including the Euroqol-5 Dimensions and ICECAP Supportive Care measures. Qualitative data will be collected at 3 months to explore the participants' experiences of the trial and therapy. Data will be collected on the costs of care. Data generated on the recruitment, retention, and experience of the

  18. Use of the experience sampling method in the context of clinical trials

    Science.gov (United States)

    Verhagen, Simone J W; Hasmi, Laila; Drukker, Marjan; van Os, J; Delespaul, Philippe A E G

    2016-01-01

    Objective The experience sampling method (ESM) is a structured diary technique to appraise subjective experiences in daily life. It is applied in psychiatric patients, as well as in patients with somatic illness. Despite the potential of ESM assessment, the improved logistics and its increased administration in research, its use in clinical trials remains limited. This paper introduces ESM for clinical trials in psychiatry and beyond. Methods ESM is an ecologically valid method that yields a comprehensive view of an individual's daily life. It allows the assessment of various constructs (eg, quality of life, psychopathology) and psychological mechanisms (eg, stress-sensitivity, coping). These constructs are difficult to assess using cross-sectional questionnaires. ESM can be applied in treatment monitoring, as an ecological momentary intervention, in clinical trials, or in single case clinical trials. Technological advances (eg, smartphone applications) make its implementation easier. Results Advantages of ESM are highlighted and disadvantages are discussed. Furthermore, the ecological nature of ESM data and its consequences are explored, including the potential pitfalls of ambiguously formulated research questions and the specificities of ESM in statistical analyses. The last section focuses on ESM in relation to clinical trials and discusses its future use in optimising clinical decision-making. Conclusions ESM can be a valuable asset in clinical trial research and should be used more often to study the benefits of treatment in psychiatry and somatic health. PMID:27443678

  19. Neck collar, "act-as-usual" or active mobilization for whiplash injury? A randomized parallel-group trial

    DEFF Research Database (Denmark)

    Kongsted, Alice; Montvilas, Erisela Qerama; Kasch, Helge

    2007-01-01

    Study Design. Randomized, parallel-group trial. Objective. To compare the effect of 3 early intervention strategies following whiplash injury. Summary of Background Data. Long-lasting pain and disability, known as chronic whiplash-associated disorder (WAD), may develop after a forced flexion......-extension trauma to the cervical spine. It is unclear whether this, in some cases disabling, condition can be prevented by early intervention. Active interventions have been recommended but have not been compared with information only. Methods. Participants were recruited from emergency units and general...... practitioners within 10 days after a whiplash injury and randomized to: 1) immobilization of the cervical spine in a rigid collar followed by active mobilization, 2) advice to "act-as-usual," or 3) an active mobilization program (Mechanical Diagnosis and Therapy). Follow-up was carried out after 3, 6, and 12...

  20. Neck collar, "act-as-usual" or active mobilization for whiplash injury? A randomized parallel-group trial

    DEFF Research Database (Denmark)

    Kongsted, Alice; Montvilas, Erisela Qerama; Kasch, Helge

    2007-01-01

    practitioners within 10 days after a whiplash injury and randomized to: 1) immobilization of the cervical spine in a rigid collar followed by active mobilization, 2) advice to "act-as-usual," or 3) an active mobilization program (Mechanical Diagnosis and Therapy). Follow-up was carried out after 3, 6, and 12......-extension trauma to the cervical spine. It is unclear whether this, in some cases disabling, condition can be prevented by early intervention. Active interventions have been recommended but have not been compared with information only. Methods. Participants were recruited from emergency units and general......Study Design. Randomized, parallel-group trial. Objective. To compare the effect of 3 early intervention strategies following whiplash injury. Summary of Background Data. Long-lasting pain and disability, known as chronic whiplash-associated disorder (WAD), may develop after a forced flexion...

  1. Student Experience of Oral Communication Assessment Tasks Online from a Multi-Disciplinary Trial

    Science.gov (United States)

    McBain, Bonnie; Drew, Antony; James, Carole; Phelan, Liam; Harris, Keith M; Archer, Jennifer

    2016-01-01

    Purpose: The purpose of this paper is to evaluate the experiences of tertiary students learning oral presentation skills in a range of online and blended learning contexts across diverse disciplines. Design/methodology/approach: The research was designed as a "federation" of trials of diverse online oral communications assessment tasks…

  2. Licensing Procedures for Sodium Experiment Facility using Safety Control of Dangerous Substances Act

    Energy Technology Data Exchange (ETDEWEB)

    Jung, Minhwan; Jeong, Jiyoung; Lee, Jewhan [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2013-10-15

    Sodium used as a coolant in the SFR is utilized in various fields and yet there has been no record of handling and storing sodium exceeding designated quantity, which is a quantity that serves as the lowest level permitted for construction. The difficulty in achieving the license for sodium experiment facilities and equipment has been the main issue since the first time of sodium-related plan. Sodium is under regulation of four kinds of laws including the Safety Control of Dangerous Substances Act and it is under categorized as Class 3(pyrophoric material and water-prohibiting substance). The objective of this study is to investigate the procedure of installing a sodium-related facility and achieving the license from the fire agency of government. In this work, the licensing procedure for a sodium experiment facility was investigated under the Safety Control of Dangerous Substances Act. For the construction of the PGSFR (Prototype Gen-IV Sodium cooled Fast Reactor), the described procedure should be reviewed and prepared carefully in accordance with the fire safety regulatory body.

  3. A trial of a brief group-based form of acceptance and commitment therapy (ACT) for chronic pain in general practice: pilot outcome and process results.

    Science.gov (United States)

    McCracken, Lance M; Sato, Ayana; Taylor, Gordon J

    2013-11-01

    Acceptance and commitment therapy (ACT) is a developing approach for chronic pain. The current study was designed to pilot test a brief, widely inclusive, local access format of ACT in a UK primary care setting. Seventy-three participants (68.5% women) were randomized to either ACT or treatment as usual (TAU). Many of the participants were aged 65 years or older (27.6%), were diagnosed with fibromyalgia (30.2%) and depression (40.3%), and had longstanding pain (median = 10 years). Standard clinical outcome measures included disability, depression, physical functioning, emotional functioning, and rated improvement. Process measures included pain-related and general psychological acceptance. The recruitment target was met within 6 months, and 72.9% of those allocated to ACT completed treatment. Immediately post treatment, relative to TAU, participants in ACT demonstrated lower depression and higher ratings of overall improvement. At a 3-month follow-up, again relative to TAU, those in ACT demonstrated lower disability, less depression, and significantly higher pain acceptance; d = .58, .59, and .64, respectively. Analyses based on intention-to-treat and on treatment "completers," perhaps predictably, revealed more sobering and more encouraging results, respectively. A larger trial of ACT delivered in primary care, in the format employed here, appears feasible with some recommended adjustments in the methods used here (Trial registration: ISRCTN49827391). This article presents a pilot randomized controlled trial of ACT for chronic pain in a primary care setting in the United Kingdom. Both positive clinical outcomes and ways to improve future trials are reported. Copyright © 2013 American Pain Society. All rights reserved.

  4. A Muhicentered Clinical Trial of the Long-acting Injectable Contraceptive Depo Provera in Chinese Women

    Institute of Scientific and Technical Information of China (English)

    SunDan-li; ShaoQing-xiang; SangGuo-wei

    2005-01-01

    This study was an open trial where 1994 subjects each received Depo Provera injectable contraceptive every three months for one year and were observed a total of 20,294.3 woman months.At the time of observation,only one accidental pregnancy had occurred giving a use-effectiveness rate of 99.94% and a cumulative continuation rate of 72.8%.There were no significant adverse effects on weight and bolld pressure.The main side effects were spotting,prolonged bleeding,and amenorrhea and these were alsothe main reasons of discontinuation.Complaints related to bleeding problems gradually decreased and complaints of amenorrhea increased with continued use. In lactating women,side effects occurrence rate was lower and continuation rate was higher in comparison with non-lactating women.Users did not report any effect on milk secretion.The results of this study confirm that Depo Provera is a very effective contraceptive method.With appropriate counseling and medical support,high acceptability and continuation rate can be achieved. Depo Provera is especially suitable for lactating women and could become a popular contraceptive method for lactating Chinese women.

  5. A randomized trial of ACT bibliotherapy on the mental health of K-12 teachers and staff.

    Science.gov (United States)

    Jeffcoat, Tami; Hayes, Steven C

    2012-09-01

    The mental health challenges of some vocations present a challenge for current intervention models. Bibliotherapy focused on transdiagnostic processes that might both prevent and alleviate a range of mental health distress could be an effective and practical approach. K-12 school personnel (N = 236; 91% female; 30-60 years old) responding to a wellness-oriented program announcement were randomized to receive an Acceptance and Commitment Therapy (ACT) self-help volume or to a waitlist. Three-fourths were above clinical cutoffs in general mental health, depression, anxiety, or stress. Participants read the book for two months, completed exercises and quizzes, and after post assessment were followed for 10 weeks; waitlist participants were then also given the book with two months to complete it. Overall, participants showed significant improvement in psychological health. Significant preventive effects for depression and anxiety were observed along with significant ameliorative effects for those in the clinical ranges of depression, anxiety and stress. Follow up general mental health, depression, and anxiety outcomes were related to the manner in which participants used the workbook and to post levels of psychological flexibility.

  6. ACGT: advancing clinico-genomic trials on cancer - four years of experience.

    Science.gov (United States)

    Martin, Luis; Anguita, Alberto; Graf, Norbert; Tsiknakis, Manolis; Brochhausen, Mathias; Rüping, Stefan; Bucur, Anca; Sfakianakis, Stelios; Sengstag, Thierry; Buffa, Francesca; Stenzhorn, Holger

    2011-01-01

    The challenges regarding seamless integration of distributed, heterogeneous and multilevel data arising in the context of contemporary, post-genomic clinical trials cannot be effectively addressed with current methodologies. An urgent need exists to access data in a uniform manner, to share information among different clinical and research centers, and to store data in secure repositories assuring the privacy of patients. Advancing Clinico-Genomic Trials (ACGT) was a European Commission funded Integrated Project that aimed at providing tools and methods to enhance the efficiency of clinical trials in the -omics era. The project, now completed after four years of work, involved the development of both a set of methodological approaches as well as tools and services and its testing in the context of real-world clinico-genomic scenarios. This paper describes the main experiences using the ACGT platform and its tools within one such scenario and highlights the very promising results obtained.

  7. The experience of older patients with cancer in phase 1 clinical trials: a qualitative case series.

    Science.gov (United States)

    Kvale, Elizabeth A; Woodby, Lesa; Williams, Beverly Rosa

    2010-11-01

    This article explores the experiences of older patients with cancer in phase 1 clinical trials. Conducting a case series of face-to-face, in-depth, open-ended interviews and using qualitative methods of analysis, we find that the psychosocial process of social comparison is relevant for understanding older adults' phase 1 clinical trial participation. Social comparison influences decisions to enroll in a phase 1 clinical trial, shapes perceptions of supportive care needs, and encourages the utilization of hope. Additional research should develop strategies for addressing supportive care needs among this patient cohort whose use of social comparison can inhibit articulation of pain, suffering, and symptom burden as well as use of informal support systems.

  8. Experiences of Biographical Crises as a Resource for Professional Interventions. An Exemplary Analysis of Lawyer's Acting

    Directory of Open Access Journals (Sweden)

    Claudia Scheid

    2008-01-01

    Full Text Available In the empirical part of the following paper, professional service is shown in the context of a biographical experience of a professional—a family law attorney. In terms of method, this undertaking is precarious. Its sense lies in gaining an understanding of the biographically and historically motivated potentials and limits of professional services. A differentiated look at professional services is facilitated when you know the stories out of which specific procedures have resulted. In overcoming the crude classification of "professionalized," "not professionalized," and "de-professionalized," it is possible to further differentiate theories of professionalization (Talcott PARSONS, Ulrich OEVERMANN, Fritz SCHÜTZE. Up until now detailed examinations are missing of the genesis of concrete professional acting, even though the topic has been worked out clearly, especially in studies of teachers' work. URN: urn:nbn:de:0114-fqs0801537

  9. Acting with dedication and expertise: Relatives' experience of nurses' provision of care in a palliative unit.

    Science.gov (United States)

    Grøthe, Å; Biong, Stian; Grov, E K

    2015-12-01

    Admission of a cancer patient to a palliative unit when near the final stage of their disease trajectory undoubtedly impacts their relatives. The aim of our study was to illuminate and interpret relatives' lived experiences of health personnel's provision of care in a palliative ward. A phenomenological/hermeneutic approach was employed that was inspired by the philosophical tradition of Heidegger and Ricoeur and further developed by Lindseth and Nordberg. The perspectives of the narrator and the text were interpreted by highlighting relatives' views on a situation in which they have to face existential challenges. The analysis was undertaken in three steps: naïve reading, structural analysis, and comprehensive understanding, including the authors' professional experiences and theoretical background. Six subthemes appeared: the dying person, the bubble, the sight, the cover, the provision for children's needs, and the availability of immediate help. These components were further constructed into three themes: the meaning of relating, the meaning of action, and the meaning of resources. Our comprehensive understanding of the results suggests that the most important theme is "acting with dedication and expertise." The following aspects are crucial for relatives of cancer patients hospitalized in a palliative ward: time and existence, family dynamics, and care adjusted to the situation. Our study results led to reflections on the impact of how nurses behave when providing care to patients during the palliative phase, and how they interact with relatives in this situation. We found that cancer patients in a palliative unit most appreciate nurses who act with dedication and expertise.

  10. Do Proficiency and Study-Abroad Experience Affect Speech Act Production? Analysis of Appropriateness, Accuracy, and Fluency

    Science.gov (United States)

    Taguchi, Naoko

    2011-01-01

    This cross-sectional study examined the effect of general proficiency and study-abroad experience in production of speech acts among learners of L2 English. Participants were 25 native speakers of English and 64 Japanese college students of English divided into three groups. Group 1 (n = 22) had lower proficiency and no study-abroad experience.…

  11. Do Proficiency and Study-Abroad Experience Affect Speech Act Production? Analysis of Appropriateness, Accuracy, and Fluency

    Science.gov (United States)

    Taguchi, Naoko

    2011-01-01

    This cross-sectional study examined the effect of general proficiency and study-abroad experience in production of speech acts among learners of L2 English. Participants were 25 native speakers of English and 64 Japanese college students of English divided into three groups. Group 1 (n = 22) had lower proficiency and no study-abroad experience.…

  12. Idiopathic pulmonary fibrosis: from clinical trials to real-life experiences

    Directory of Open Access Journals (Sweden)

    Sergio Harari

    2015-09-01

    Full Text Available Randomised controlled clinical trials are fundamental in medicine to develop new effective drugs and new therapeutic regimens and are the strength of evidence-based medicine. These studies allow us to avoid the repetition of misleading experiences that have been reported in the past, where drugs or associations were utilised without compelling evidence and ultimately proven to be ineffective. In recent years, randomised clinical trials have been conducted and concluded for many rare diseases, including idiopathic pulmonary fibrosis. However, clinical trials do not always reflect the real-life scenario. Patients selected for clinical trials present fewer comorbidities, they fall between certain age limits, and the severity of their disease is defined; therefore, they do not always reflect the whole of the population affected by a specific disease. These are the reasons why we also need data that mirror real-life experience. The limitations that these kind of studies present are always several and the studies should be interpreted with caution, although they can fill the important gap between efficacy and effectiveness. In this article, we will review the existing clinical data on real-life treatment of idiopathic pulmonary fibrosis.

  13. The Danish patient safety experience: the Act on Patient Safety in the Danish Health care system

    DEFF Research Database (Denmark)

    Lundgaard, Mette; Rabøl, Louise; Jensen, Elisabeth Agnete Brøgger

    2005-01-01

    This paper describes the process that lead to the passing of the Act for Patient Safety in the Danisk health care sytem, the contents of the act and how the act is used in the Danish health care system. The act obligates frontline health care personnel to report adverse events, hospital owners...... to act on the reports and the National Board of Health to commuicate the learning nationally. The act protects health care providers from sanctions as a result of reporting. In January 2004, the Act on Patient Safety in the Danish health care system was put into force. In the first twelve months 5740...... adverse events were reported. the reports were analyzed locally (hospital and region), anonymized ad then sent to the National Board af Health. The Act on Patient Safety has driven the work with patient safety forward but there is room for improvement. Continuous and improved feedback from all parts...

  14. Critical periods after stroke study: translating animal stroke recovery experiments into a clinical trial

    Science.gov (United States)

    Dromerick, Alexander W.; Edwardson, Matthew A.; Edwards, Dorothy F.; Giannetti, Margot L.; Barth, Jessica; Brady, Kathaleen P.; Chan, Evan; Tan, Ming T.; Tamboli, Irfan; Chia, Ruth; Orquiza, Michael; Padilla, Robert M.; Cheema, Amrita K.; Mapstone, Mark E.; Fiandaca, Massimo S.; Federoff, Howard J.; Newport, Elissa L.

    2015-01-01

    Introduction: Seven hundred ninety-five thousand Americans will have a stroke this year, and half will have a chronic hemiparesis. Substantial animal literature suggests that the mammalian brain has much potential to recover from acute injury using mechanisms of neuroplasticity, and that these mechanisms can be accessed using training paradigms and neurotransmitter manipulation. However, most of these findings have not been tested or confirmed in the rehabilitation setting, in large part because of the challenges in translating a conceptually straightforward laboratory experiment into a meaningful and rigorous clinical trial in humans. Through presentation of methods for a Phase II trial, we discuss these issues and describe our approach. Methods: In rodents there is compelling evidence for timing effects in rehabilitation; motor training delivered at certain times after stroke may be more effective than the same training delivered earlier or later, suggesting that there is a critical or sensitive period for strongest rehabilitation training effects. If analogous critical/sensitive periods can be identified after human stroke, then existing clinical resources can be better utilized to promote recovery. The Critical Periods after Stroke Study (CPASS) is a phase II randomized, controlled trial designed to explore whether such a sensitive period exists. We will randomize 64 persons to receive an additional 20 h of upper extremity therapy either immediately upon rehab admission, 2–3 months after stroke onset, 6 months after onset, or to an observation-only control group. The primary outcome measure will be the Action Research Arm Test (ARAT) at 1 year. Blood will be drawn at up to 3 time points for later biomarker studies. Conclusion: CPASS is an example of the translation of rodent motor recovery experiments into the clinical setting; data obtained from this single site randomized controlled trial will be used to finalize the design of a Phase III trial. PMID

  15. Streamlining IRB review in multisite trials through single-study IRB Cooperative Agreements: experience of the Beta-Carotene and Retinol Efficacy Trial (CARET).

    Science.gov (United States)

    Thornquist, Mark D; Edelstein, Cim; Goodman, Gary E; Omenn, Gilbert S

    2002-02-01

    With their extensive data and specimen repositories, clinical trials are a long-term, valuable resource to health researchers. However, assuring protection of participants' rights can be challenging, particularly when such trials are conducted at multiple sites with multiple Institutional Review Boards (IRBs). One little-used mechanism that can streamline IRB review in multisite trials while maintaining participants' protections is the single-study IRB Cooperative Agreement. This agreement is entirely different from reciprocity agreements between institutions. Beginning in 1996, the Beta-Carotene and Retinol Efficacy Trial established single-study IRB Cooperative Agreements among its performance sites, which reduced the average time to complete IRB approval from over 6 months to 1 month for each of many substudies. We describe our experience and make recommendations for other multisite clinical trials.

  16. Cognitive-behavioral therapy (CBT) versus acceptance and commitment therapy (ACT) for dementia family caregivers with significant depressive symptoms: Results of a randomized clinical trial.

    Science.gov (United States)

    Losada, Andrés; Márquez-González, María; Romero-Moreno, Rosa; Mausbach, Brent T; López, Javier; Fernández-Fernández, Virginia; Nogales-González, Celia

    2015-08-01

    The differential efficacy of acceptance and commitment therapy (ACT) and cognitive-behavioral therapy (CBT) for dementia family caregivers' is analyzed through a randomized controlled trial. Participants were 135 caregivers with high depressive symptomatology who were randomly allocated to the intervention conditions or a control group (CG). Pre-, postintervention, and follow-up measurements assessed depressive symptomatology, anxiety, leisure, dysfunctional thoughts, and experiential avoidance. Depression: Significant effects of interventions compared with CG were found for CBT (p < .001, d = 0.98, number needed to treat [NNT] = 3.61) and ACT (p < .001, d = 1.17, NNT = 3.53) at postintervention, but were maintained only at follow-up for CBT (p = .02, d = 0.74, NNT = 9.71). Clinically significant change was observed in 26.7% participants in CBT, 24.2% in ACT, and 0% in CG. At follow-up, 10.53% in CBT and 4% in ACT were recovered (0% CG). Anxiety: At postintervention, ACT participants showed lower anxiety than CBT participants (p < .05, d = 0.50) and CG participants (p < .01, d = 0.79, NNT = 3.86), with no effects at follow-up. At postintervention, 23.33% in CBT, 36.36% in ACT, and 6.45% in CG showed clinically significant change. At follow-up, 26.32% in CBT, 36% in ACT, and 13.64% in CG were recovered. Significant changes at postintervention were found in leisure and dysfunctional thoughts in both ACT and CBT, with changes in experiential avoidance only for ACT. Similar results were obtained for ACT and CBT. ACT seems to be a viable and effective treatment for dementia caregivers. (c) 2015 APA, all rights reserved).

  17. Exploring User Experience of a Telehealth System for the Danish TeleCare North Trial.

    Science.gov (United States)

    Lilholt, Pernille Heyckendorff; Hæsum, Lisa Korsbakke Emtekær; Hejlesen, Ole Kristian

    2015-01-01

    The aim was to explore user experiences of using a telehealth system (Telekit) designed for the Danish TeleCare North trial. Telekit is designed for patients diagnosed with chronic obstructive pulmonary disease (COPD) in order to manage the disease and support patient empowerment. This article sums up COPD-participants' user experiences in terms of increased sense of freedom, of security, of control, and greater awareness of COPD symptoms. A consecutive sample of sixty participants (27 women, 33 men) were recruited from the TeleCare North trial. At home the participants completed a non-standardised questionnaire while a researcher was present. The questionnaire identified their health status, their use of specific technologies, and their user experiences with the telehealth system. Results from the questionnaire indicate that the majority of participants (88%) considered the Telekit system as easy to use. 43 (72%) participants felt increased sense of security, and 37 (62%) participants felt increased sense of control by using the system. 30 (50%) participants felt greater awareness of their COPD symptoms, but only 16 (27%) participants felt increased freedom. The study has provided a general picture of COPD participants' user experiences which is important to emphasise as it has a bearing on whether a given implementation will be successful or not.

  18. Inactive experiments for advanced separation processes prior to high activity trials in ATALANTE

    Energy Technology Data Exchange (ETDEWEB)

    Duhamet, Jean; Lanoe, Jean-Yves; Rivalier, Patrick; Borda, Gilles [Commissariat a l' Energie Atomique (CEA), CEA/DEN/VRH/DTEC/SGCS, Centre de Marcoule - BP 17171, 302007 Bagnols-sur-Ceze cedex (France)

    2008-07-01

    Many trials have been performed in ATALANTE's shielded cells to demonstrate the technical feasibility of processes involving minor actinide separation. They required developments of new extractors as well as a step by step procedure have been used to lower the risks of malfunction during high active operation. The design of the extractors developed by Cea has included shielded cells restrictions, miniaturization to lower the quantity of high active material and wastes and the care for being representative of industrial equipment. After individual shake down inactive tests, with actual phases, each process experiment scheduled in ATALANTE has been tested at G1 Facility in Marcoule. The objective was to reproduce as much as possible all the equipment chosen for active tests. This procedure has demonstrated its efficiency to detect many problems that would have heavy impact if they have been discovered during active trials. It was also used for operators'training. (authors)

  19. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial.

    Science.gov (United States)

    Bekelis, Kimon; Calnan, Daniel; Simmons, Nathan; MacKenzie, Todd A; Kakoulides, George

    2017-06-01

    To investigate the effect of exposure to a virtual reality (VR) environment preoperatively on patient-reported outcomes for surgical operations. There is a scarcity of well-developed quality improvement initiatives targeting patient satisfaction. We performed a randomized controlled trial of patients undergoing cranial and spinal operations in a tertiary referral center. Patients underwent a 1:1 randomization to an immersive preoperative VR experience or standard preoperative experience stratified on type of operation. The primary outcome measures were the Evaluation du Vecu de l'Anesthesie Generale (EVAN-G) score and the Amsterdam Preoperative Anxiety and Information (APAIS) score, as markers of the patient's experience during the surgical encounter. During the study period, a total of 127 patients (mean age 55.3 years, 41.9% females) underwent randomization. The average EVAN-G score was 84.3 (standard deviation, SD, 6.4) after VR, and 64.3 (SD, 11.7) after standard preoperative experience (difference, 20.0; 95% confidence interval, CI, 16.6-23.3). Exposure to an immersive VR experience also led to higher APAIS score (difference, 29.9; 95% CI, 24.5-35.2). In addition, VR led to lower preoperative VAS stress score (difference, -41.7; 95% CI, -33.1 to -50.2), and higher preoperative VAS preparedness (difference, 32.4; 95% CI, 24.9-39.8), and VAS satisfaction (difference, 33.2; 95% CI, 25.4-41.0) scores. No association was identified with VAS stress score (difference, -1.6; 95% CI, -13.4 to 10.2). In a randomized controlled trial, we demonstrated that patients exposed to preoperative VR had increased satisfaction during the surgical encounter. Harnessing the power of this technology, hospitals can create an immersive environment that minimizes stress, and enhances the perioperative experience.

  20. A phase 2 trial of long-acting TransCon growth hormone in adult GH deficiency

    Directory of Open Access Journals (Sweden)

    Charlotte Höybye

    2017-03-01

    Full Text Available TransCon growth hormone is a sustained-release human growth hormone prodrug under development in which unmodified growth hormone is transiently linked to a carrier molecule. It is intended as an alternative to daily growth hormone in the treatment of growth hormone deficiency. This was a multi-center, randomized, open-label, active-controlled trial designed to compare the safety (including tolerability and immunogenicity, pharmacokinetics and pharmacodynamics of three doses of weekly TransCon GH to daily growth hormone (Omnitrope. Thirty-seven adult males and females diagnosed with adult growth hormone deficiency and stable on growth hormone replacement therapy for at least 3 months were, following a wash-out period, randomized (regardless of their pre-study dose to one of three TransCon GH doses (0.02, 0.04 and 0.08 mg GH/kg/week or Omnitrope 0.04 mg GH/kg/week (divided into 7 equal daily doses for 4 weeks. Main outcomes evaluated were adverse events, immunogenicity and growth hormone and insulin-like growth factor 1 levels. TransCon GH was well tolerated; fatigue and headache were the most frequent drug-related adverse events and reported in all groups. No lipoatrophy or nodule formation was reported. No anti-growth hormone-binding antibodies were detected. TransCon GH demonstrated a linear, dose-dependent increase in growth hormone exposure without accumulation. Growth hormone maximum serum concentration and insulin-like growth factor 1 exposure were similar after TransCon GH or Omnitrope administered at comparable doses. The results suggest that long-acting TransCon GH has a profile similar to daily growth hormone but with a more convenient dosing regimen. These findings support further TransCon GH development.

  1. A phase 2 trial of long-acting TransCon growth hormone in adult GH deficiency.

    Science.gov (United States)

    Höybye, Charlotte; Pfeiffer, Andreas F H; Ferone, Diego; Christiansen, Jens Sandahl; Gilfoyle, David; Christoffersen, Eva Dam; Mortensen, Eva; Leff, Jonathan A; Beckert, Michael

    2017-04-01

    TransCon growth hormone is a sustained-release human growth hormone prodrug under development in which unmodified growth hormone is transiently linked to a carrier molecule. It is intended as an alternative to daily growth hormone in the treatment of growth hormone deficiency. This was a multi-center, randomized, open-label, active-controlled trial designed to compare the safety (including tolerability and immunogenicity), pharmacokinetics and pharmacodynamics of three doses of weekly TransCon GH to daily growth hormone (Omnitrope). Thirty-seven adult males and females diagnosed with adult growth hormone deficiency and stable on growth hormone replacement therapy for at least 3 months were, following a wash-out period, randomized (regardless of their pre-study dose) to one of three TransCon GH doses (0.02, 0.04 and 0.08 mg GH/kg/week) or Omnitrope 0.04 mg GH/kg/week (divided into 7 equal daily doses) for 4 weeks. Main outcomes evaluated were adverse events, immunogenicity and growth hormone and insulin-like growth factor 1 levels. TransCon GH was well tolerated; fatigue and headache were the most frequent drug-related adverse events and reported in all groups. No lipoatrophy or nodule formation was reported. No anti-growth hormone-binding antibodies were detected. TransCon GH demonstrated a linear, dose-dependent increase in growth hormone exposure without accumulation. Growth hormone maximum serum concentration and insulin-like growth factor 1 exposure were similar after TransCon GH or Omnitrope administered at comparable doses. The results suggest that long-acting TransCon GH has a profile similar to daily growth hormone but with a more convenient dosing regimen. These findings support further TransCon GH development.

  2. Speech-Act Theory as a New Way of Conceptualizing the "Student Experience"

    Science.gov (United States)

    Fisher, Andrew

    2010-01-01

    This article has four aims. The first is to characterize the key features of speech-act theory, and, in particular, to show that there is a genuine distinction between the sound uttered when someone is speaking (locution), the effect the speech has (perlocution) and the very "act" of speaking (the illocution). Secondly, it aims to…

  3. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia.

    Science.gov (United States)

    Osrin, David; Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M

    2009-10-01

    Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of - and responsibility for - group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.

  4. Self-reported experience in patients treated with Hepatitis C direct acting antivirals

    Directory of Open Access Journals (Sweden)

    Irene Cañamares Orbis

    2016-12-01

    Full Text Available Background and objective: To learn about and analyze the self-reported treatment experience of HCV patients who started treatment with direct acting antivirals agents (DAA, at a real-time, proactive and integrated into the pharmaceutical care healthcare process, using a prospective questionnaire completed by patients as clinical tool. Material and methods: Observational and cross-sectional study conducted between April (start of the National Strategic Plan and December 2015 in the Outpatient Pharmacy Service. The questionnaire includes variables related to health related quality of life (HRQOL, adherence, adverse effects (AEs, satisfaction, and usefulness of the Pharmacy Service implemented training program. A descriptive analysis of all variables included in the study was conducted and the influence of different variables analyzed in the degree of adherence and HRQOL. The analysis of the differences was performed using chi-square test and simple logistic regresión model for calculation of OR. We use SPSS version 20 program and statistical significance for values of p < 0.05 was considered. Results: 155 of the 226 surveys returned, with a response rate of 68.6%. Referring to the HRQOL (evaluation of physical and emotional state, 38.7% of patients reports that their physical and emotional state is much better from the start of treatment. The presence of EA and worse global information of their disease was associated with worse physical and emotional state (p < 0.05. Reported adherence was 84.5% and the treatment was evaluated as very good or good by 87% of patients. 52.9% had no adverse effects related to the medication and the training process performed by the specialist pharmacist at the first visit 96.7% of patients assessed as very good or good. Conclusions: Self-reported experience acquired through direct and constant contact with patients provides information on important aspects of treatment. We believe that these tools should be

  5. Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

    Directory of Open Access Journals (Sweden)

    Rahu Mati

    2008-08-01

    Full Text Available Abstract Background Preventive drugs require long-term trials to show their effectiveness or harms and often a lot of changes occur during post-marketing studies. The purpose of this article is to describe the research process in a long-term randomized controlled trial and discuss the impact and consequences of changes in the research environment. Methods The Estonian Postmenopausal Hormone Therapy trial (EPHT, originally planned to continue for five years, was planned in co-operation with the Women's International Study of Long-Duration Oestrogen after Menopause (WISDOM in the UK. In addition to health outcomes, EPHT was specifically designed to study the impact of postmenopausal hormone therapy (HT on health services utilization. Results After EPHT recruited in 1999–2001 the Women's Health Initiative (WHI in the USA decided to stop the estrogen-progestin trial after a mean of 5.2 years in July 2002 because of increased risk of breast cancer and later in 2004 the estrogen-only trial because HT increased the risk of stroke, decreased the risk of hip fracture, and did not affect coronary heart disease incidence. WISDOM was halted in autumn 2002. These decisions had a major influence on EPHT. Conclusion Changes in Estonian society challenged EPHT to find a balance between the needs of achieving responses to the trial aims with a limited budget and simultaneously maintaining the safety of trial participants. Flexibility was the main key for success. Rapid changes are not limited only to transiting societies but are true also in developed countries and the risk must be included in planning all long-term trials. The role of ethical and data monitoring committees in situations with emerging new data from other studies needs specification. Longer funding for preventive trials and more flexibility in budgeting are mandatory. Who should prove the effectiveness of an (old drug for a new preventive indication? In preventive drug trials companies may

  6. Socially-marketed rapid diagnostic tests and ACT in the private sector: ten years of experience in Cambodia

    Directory of Open Access Journals (Sweden)

    Allen Henrietta

    2011-08-01

    Full Text Available Abstract Whilst some populations have recently experienced dramatic declines in malaria, the majority of those most at risk of Plasmodium falciparum malaria still lack access to effective treatment with artemisinin combination therapy (ACT and others are already facing parasites resistant to artemisinins. In this context, there is a crucial need to improve both access to and targeting of ACT through greater availability of good quality ACT and parasitological diagnosis. This is an issue of increasing urgency notably in the private commercial sector, which, in many countries, plays an important role in the provision of malaria treatment. The Affordable Medicines Facility for malaria (AMFm is a recent initiative that aims to increase the provision of affordable ACT in public, private and NGO sectors through a manufacturer-level subsidy. However, to date, there is little documented experience in the programmatic implementation of subsidized ACT in the private sector. Cambodia is in the unique position of having more than 10 years of experience not only in implementing subsidized ACT, but also rapid diagnostic tests (RDT as part of a nationwide social marketing programme. The programme includes behaviour change communication and the training of private providers as well as the sale and distribution of Malarine, the recommended ACT, and Malacheck, the RDT. This paper describes and evaluates this experience by drawing on the results of household and provider surveys conducted since the start of the programme. The available evidence suggests that providers' and consumers' awareness of Malarine increased rapidly, but that of Malacheck much less so. In addition, improvements in ACT and RDT availability and uptake were relatively slow, particularly in more remote areas. The lack of standardization in the survey methods and the gaps in the data highlight the importance of establishing a clear system for monitoring and evaluation for similar initiatives

  7. Long acting β2 agonists for stable chronic obstructive pulmonary disease with poor reversibility: a systematic review of randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Mensinkai Shaila

    2004-08-01

    Full Text Available Abstract Background The long acting β2-agonists, salmeterol and formoterol, have been recommended, by some, as first line treatment of stable chronic obstructive pulmonary disease (COPD. We reviewed evidence of efficacy and safety when compared with placebo or anticholinergic agents in patients with poorly reversible COPD. Methods After searching MEDLINE, EMBASE, HealthSTAR, BIOSIS Previews, PASCAL, ToxFile, SciSearch, the Cochrane Library, and PubMed, as well as Web sites, selected journals, reference lists, and contacting drug manufacturers, two reviewers independently screened reports of randomised controlled trials of parallel or crossover design lasting four weeks or longer and including patients with a forced expiratory volume in one second (FEV1 ≤ 75% of predicted, a ratio of FEV1 to forced vital capacity (FVC ≤ 88% of predicted, and Results Twelve trials satisfied our inclusion criteria; eight were high quality (Jadad score >2 and four were low quality (≤ 2. The adequacy of allocation concealment was unclear in all of them. We did not perform a meta-analysis due to differences in trial design and how outcomes were reported. Two trials comparing salmeterol with ipratropium did not detect differences; one trial comparing formoterol and ipratropium described greater improvement with formoterol in morning PEFR (15.3 versus 7.1 l/min, p = 0.040. Of twelve trials comparing long acting β2 agonists with placebo, six reported no improvement in exercise capacity, eleven reported improvements in FEV1 lung function (one reported no improvement, six reported less rescue inhaler usage (one reported no difference and five reported improved dyspnea scores (two reported no improvement. Differences in quality of life were detected in one salmeterol trial ; however, two salmeterol, and one formoterol trial reported no differences. Adverse effects of interest were not reported. Conclusion In terms of clinical outcomes and safety, we could not find

  8. 'We knew it was a totally at random thing': parents' experiences of being part of a neonatal trial.

    Science.gov (United States)

    Harvey, Merryl; Nongena, Phumza; Edwards, David; Redshaw, Maggie

    2017-08-01

    Studies exploring parents' trial experiences generally relate to their understanding of the consent process and the development of researcher strategies to facilitate recruitment and retention. The aim was to better understand parents' experience of being part of a trial at the time and their perceptions of trial participation in retrospect. Data were collected in a number of ways: from recorded discussions between parents and clinicians about the MRI or ultrasound, in open-text responses to questionnaires and in qualitative interviews at 1 and 2 years after participation. Thematic analysis was undertaken using NVivo10. Key themes identified were 'deciding to take part', with subthemes associated with 'benefitting self', 'benefitting others' and 'being prepared'; 'the randomisation process' with subthemes relating to 'acceptance' and 'understanding' and 'actual engagement' with subthemes of 'practicalities' and 'care from responsive staff'. Parents' perspectives on the trial and the processes and information received reflect their understanding and experience of the trial and the value of parent-friendly information-giving about participation, randomisation and follow-up. The practical and logistical points raised confirm the key issues and parents' need for sensitive care and support in the course of a trial. Looking back, almost all parents were positive about their experience and felt that the family had benefitted from participation in the trial and follow-up studies, even when the developmental outcomes were poor. ClinicalTrials.gov, ID: NCT01049594. https://clinicaltrials.gov/ct2/show/NCT01049594 . Registered on 13 January 2010. EudraCT: EudraCT: 2009-011602-42. https://www.clinicaltrialsregister.eu/ .

  9. Prediction of responders for outcome measures of Locomotor Experience Applied Post Stroke trial

    Directory of Open Access Journals (Sweden)

    Bruce H. K. Dobkin, MD

    2014-03-01

    Full Text Available The Locomotor Experience Applied Post Stroke rehabilitation trial found equivalent walking outcomes for body weight-supported treadmill plus overground walking practice versus home-based exercise that did not emphasize walking. From this large database, we examined several clinically important questions that provide insights into recovery of walking that may affect future trial designs. Using logistic regression analyses, we examined predictors of response based on a variety of walking speed-related outcomes and measures that captured disability, physical impairment, and quality of life. The most robust predictor was being closer at baseline to the primary outcome measure, which was the functional walking speed thresholds of 0.4 m/s (household walking and 0.8 m/s (community walking. Regardless of baseline walking speed, a younger age and higher Berg Balance Scale score were relative predictors of responding, whether operationally defined by transitioning beyond each speed boundary or by a continuous change or a greater than median increase in walking speed. Of note, the cutoff values of 0.4 and 0.8 m/s had no particular significance compared with other walking speed changes despite their general use as descriptors of functional levels of walking. No evidence was found for any difference in predictors based on treatment group.

  10. Genetic differential susceptibility on trial: meta-analytic support from randomized controlled experiments.

    Science.gov (United States)

    van Ijzendoorn, Marinus H; Bakermans-Kranenburg, Marian J

    2015-02-01

    The most stringent test of differential susceptibility theory is provided by randomized control trials examining the moderating role of genetic markers of differential susceptibility in experimental manipulations of the environment (Gene × Experimental Environment interactions), being at least 10 times more powerful than correlational Gene × Environment interaction studies. We identified 22 experiments involving 3,257 participants with various developmental outcomes (e.g., externalizing problems, internalizing behaviors, and cognitive development). Effect sizes contrasting experimental versus control group were computed both for subjects with the polymorphism considered indicative of heightened susceptibility (e.g., the dopamine receptor D4 gene seven-repeat allele and the serotonin transporter polymorphic region short allele) and others expected to be low in susceptibility (e.g., the dopamine receptor D4 gene four-repeat allele and the serotonin transporter polymorphic region short allele). Clear-cut experimental support for genetic differential susceptibility emerged: the combined effect size of the interventions for the susceptible genotypes amounted to r = .33 (95% confidence interval = 0.23, 0.42; p differential susceptibility than microtrials, and differential susceptibility was more clearly observed in trials with externalizing and cognitive outcomes than with internalizing problems. This meta-analysis shows proof of principle for genetic differential susceptibility and indicates that it is time to explore its mechanisms and limits. The concept of differential susceptibility alters the idea of constitutional "risk" factors (reactive temperament and risk genotypes), and points to intervention efficacy hidden in Gene × Environment interactions.

  11. Linking global scenarios to national assessments: Experiences from the Resources Planning Act (RPA) Assessment

    Science.gov (United States)

    Linda L. Langner; Peter J. Ince

    2012-01-01

    The Resources Planning Act (RPA) Assessment provides a nationally consistent analysis of the status and trends of the Nation's renewable forest resources. A global scenario approach was taken for the 2010 RPA Assessment to provide a shared world view of potential futures. The RPA Assessment scenarios were linked to the global scenarios and climate projections used...

  12. 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.

  13. "Novel Approach for Maximizing Follow-up in Cosmetic Surgery Clinical Trials: The Ideal Implant Core Trial Experience".

    Science.gov (United States)

    Mueller, Melissa A; Nichter, Larry S; Hamas, Robert S

    2017-06-12

    High follow-up rates are critical for robust research with minimal bias and particularly important for breast implant Core Studies seeking FDA approval. The Core Study for IDEAL IMPLANT, the most recently FDA-approved breast implant, utilized a novel incentive payment model to achieve higher follow-up rates than in previous breast implant trials. At enrollment, $3,500 was deposited into an independent, irrevocable trust for each of the 502 subjects and invested in a diversified portfolio. If a follow-up visit is missed, the subject is exited from the study and compensated for completed visits, but the remainder of her share of the funds stay in the trust. At the conclusion of the 10-year study, the trust will be divided among those subjects who completed all required follow-up visits. For primary and revision augmentation cohorts, FDA published follow-up rates from Core Studies were compared for all currently available breast implants. Five-year follow-up rates for the IDEAL IMPLANT Core Study are higher for both primary augmentation and revision augmentation cohorts (94.9% and 96.7%, respectively) when compared to all other trials that have used FDA standardized follow-up reporting (MemoryShape,® Allergan 410,® and Sientra® Core Studies). This trial demonstrates the utility of a novel incentive strategy to maximize follow-up in cosmetic surgery patients. This strategy may benefit future cosmetic surgery trials and perhaps any prospective research trial by providing more complete data.

  14. The sexual history provisions in the Youth Justice and Criminal Evidence Act 1999--a violation of the right to a fair trial?

    Science.gov (United States)

    Young, G

    2001-07-01

    In response to the Home Office recommendations contained in Speaking Up for Justice (1998) the Youth Justice and Criminal Evidence Act (YJCEA) 1999 introduced a new regime for the conduct of sexual offence trials. Section 41 of the Act, which came into force on 4 December 2000, brings about dramatic changes to the rules on the admissibility of evidence of complainants' sexual behaviour, severely restricting the discretion of trial judges to introduce such evidence or to allow questioning concerning it. This represents a radical new departure that will fundamentally affect an accused's position at trial. Responses to section 41 have predictably been divided given the extremely sensitive nature of this area of the law of evidence and the complex set of social and political issues which are at stake. Many have greeted it as a long overdue reform of a system premised upon outmoded and sexist beliefs concerning women's sexual behaviour which has routinely functioned to admit prejudicial and irrelevant evidence. Others, predominantly within the legal profession, have expressed serious concerns over whether the new law is workable and the extent to which, by potentially excluding critically relevant evidence, it may infringe upon a defendant's right to a fair trial. The quality of the legislation is soon to be tested. On 26 and 27 March 2001 the House of Lords heard an interlocutory appeal in the case of R v. A and were asked to decide if the new provisions, by excluding previous sexual history evidence between the complainant and the defendant, contravened Article 6 of the European Convention of Human Rights. Their Lordships are, at the time of writing, yet to give judgment and the fate of the defendant in question, and several others whose trials have been postponed pending their decision, hangs in the balance. This article seeks to show that the new Act, despite being well-intentioned, does not adopt a coherent or sustainable approach to the relevance of previous

  15. Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: a study protocol for a randomised trial

    Science.gov (United States)

    Kallesøe, Karen Hansen; Schröder, Andreas; Wicksell, Rikard K; Fink, Per; Ørnbøl, Eva; Rask, Charlotte Ulrikka

    2016-01-01

    Introduction Functional somatic syndromes (FSS) are common in adolescents, characterised by severe disability and reduced quality of life. Behavioural treatments such as acceptance and commitment therapy (ACT) has shown promising results in children and adolescents with FSS, but has focused on specific syndromes such as functional pain. The current study will compare the efficacy of group-based ACT with that of enhanced usual care (EUC) in adolescents with a range of FSS operationalised by the unifying construct of multiorgan bodily distress syndrome (BDS). Methods and analysis A total of 120 adolescents aged 15–19 and diagnosed with multiorgan BDS, of at least 12 months duration, will be assessed and randomised to either: (1) EUC: a manualised consultation with a child and adolescent psychiatrist and individualised treatment plan or (2) manualised ACT-based group therapy plus EUC. The ACT programme consists of 9 modules (ie, 27 hours) and 1 follow-up meeting (3 hours). The primary outcome is physical health, assessed by an Short Form Health Survey (SF-36) aggregate score 12 months after randomisation. Secondary outcomes include self-reported symptom severity, symptom interference, depression and anxiety, illness worry, perceived stress and global improvement; as well as objective physical activity and bodily stress response measured by heart rate variability, hair cortisol and inflammatory biomarkers. Process measures are illness perception, illness-related behaviour and psychological flexibility. Ethics and dissemination The study is conducted in accordance with Helsinki Declaration II. Approval has been obtained from the Science Ethics Committee of the Central Denmark Region and the Danish Data Protection. The results will be sought to be published according to the CONSORT statement in peer-reviewed journals. Discussion This is one of the first larger randomised clinical trials evaluating the effect of a group-based intervention for adolescents with a

  16. Are Clinical Trial Experiences Utilized?: A Differentiated Model of Medical Sites’ Information Transfer Ability

    DEFF Research Database (Denmark)

    Smed, Marie; Schultz, Carsten; Getz, Kenneth A.;

    2015-01-01

    The collaboration with medical professionals in pharmaceutical clinical trials facilitates opportunities to gain valuable market information concerning product functionality issues, as well as issues related to market implementation and adoption. However, previous research on trial management lac...

  17. Biomarkers in phase I–II chemoprevention trials: lessons from the NCI experience

    OpenAIRE

    Szabo, Eva

    2015-01-01

    Early phase clinical trials are an essential component of chemopreventive drug development to identify signals of drug efficacy that can subsequently be explored definitively in phase III trials. Whereas phase I trials focus on safety and identification of optimal dose and schedule for cancer prevention, phase II trials focus on intermediate endpoints that are variably related to cancer development. The United States National Cancer Institute supports a programme devoted to early phase cancer...

  18. [Influence of the Nuremberg physicians' trials--beginning a new era in the ethical judging of human experiments].

    Science.gov (United States)

    Kerpel-Fronius, Sándor

    2008-02-03

    This short historical review attempts to shed light on the tortuous road on which society moved toward the general acceptance of the idea of experimenting on human beings. Unfortunately people had to realize that under antihuman or lenient political leadership, some physicians might apply their knowledge against their fellow beings, or might endanger them while pursuing their scientific goals. For this reason, it became necessary to codify the ethical requirements of medical experiments. This was done first by the Prussian government in 1900. The historical significance of the Nuremberg physicians' trials is that, by recognizing the enormous scientific importance of human experiments, they led to the formulation of general ethical principles governing human studies, which became known as the Nuremberg Code. Broad, international regulations were developed as the consequence of the trial. Unfortunately human experiments performed on prison inmates were judged at the trial as ethically acceptable, provided an informed consent was signed. Misusing this possibility many unethical experiments were done primarily in the US after the war. The great indignation due to ethical misconduct in prison trials and the highly unethical Tuskegee experiments performed on black Americans' suffering from syphilis, led much later to the organization of independent ethics committees. Through these committees, society exercises supervision of human trials. However, in case of severely ill patients the physician might be left alone to make a quick, and ethically correct, decision corresponding to the situation. In the final analysis the safety and ethical protection of research subjects remain the joint responsibility of society and of the experimenting physicians.

  19. Experience Sampling-Based Personalized Feedback and Positive Affect: A Randomized Controlled Trial in Depressed Patients

    Science.gov (United States)

    Hartmann, Jessica A.; Wichers, Marieke; Menne-Lothmann, Claudia; Kramer, Ingrid; Viechtbauer, Wolfgang; Peeters, Frenk; Schruers, Koen R. J.; van Bemmel, Alex L.; Myin-Germeys, Inez; Delespaul, Philippe; van Os, Jim; Simons, Claudia J. P.

    2015-01-01

    Objectives Positive affect (PA) plays a crucial role in the development, course, and recovery of depression. Recently, we showed that a therapeutic application of the experience sampling method (ESM), consisting of feedback focusing on PA in daily life, was associated with a decrease in depressive symptoms. The present study investigated whether the experience of PA increased during the course of this intervention. Design Multicentre parallel randomized controlled trial. An electronic random sequence generator was used to allocate treatments. Settings University, two local mental health care institutions, one local hospital. Participants 102 pharmacologically treated outpatients with a DSM-IV diagnosis of major depressive disorder, randomized over three treatment arms. Intervention Six weeks of ESM self-monitoring combined with weekly PA-focused feedback sessions (experimental group); six weeks of ESM self-monitoring combined with six weekly sessions without feedback (pseudo-experimental group); or treatment as usual (control group). Main outcome The interaction between treatment allocation and time in predicting positive and negative affect (NA) was investigated in multilevel regression models. Results 102 patients were randomized (mean age 48.0, SD 10.2) of which 81 finished the entire study protocol. All 102 patients were included in the analyses. The experimental group did not show a significant larger increase in momentary PA during or shortly after the intervention compared to the pseudo-experimental or control groups (χ2 (2) =0.33, p=.846). The pseudo-experimental group showed a larger decrease in NA compared to the control group (χ2 (1) =6.29, p=.012). Conclusion PA-focused feedback did not significantly impact daily life PA during or shortly after the intervention. As the previously reported reduction in depressive symptoms associated with the feedback unveiled itself only after weeks, it is conceivable that the effects on daily life PA also evolve

  20. ACTS (Advanced Communications Technology Satellite) Propagation Experiment: Preprocessing Software User's Manual

    Science.gov (United States)

    Crane, Robert K.; Wang, Xuhe; Westenhaver, David

    1996-01-01

    The preprocessing software manual describes the Actspp program originally developed to observe and diagnose Advanced Communications Technology Satellite (ACTS) propagation terminal/receiver problems. However, it has been quite useful for automating the preprocessing functions needed to convert the terminal output to useful attenuation estimates. Prior to having data acceptable for archival functions, the individual receiver system must be calibrated and the power level shifts caused by ranging tone modulation must be received. Actspp provides three output files: the daylog, the diurnal coefficient file, and the file that contains calibration information.

  1. Deep brain stimulation in early stage Parkinson's disease: operative experience from a prospective randomised clinical trial.

    Science.gov (United States)

    Kahn, Elyne; D'Haese, Pierre-Francois; Dawant, Benoit; Allen, Laura; Kao, Chris; Charles, P David; Konrad, Peter

    2012-02-01

    Recent evidence suggests that deep brain stimulation of the subthalamic nucleus (STN-DBS) may have a disease modifying effect in early Parkinson's disease (PD). A randomised, prospective study is underway to determine whether STN-DBS in early PD is safe and tolerable. 15 of 30 early PD patients were randomised to receive STN-DBS implants in an institutional review board approved protocol. Operative technique, location of DBS leads and perioperative adverse events are reported. Active contact used for stimulation in these patients was compared with 47 advanced PD patients undergoing an identical procedure by the same surgeon. 14 of the 15 patients did not sustain any long term (>3 months) complications from the surgery. One subject suffered a stroke resulting in mild cognitive changes and slight right arm and face weakness. The average optimal contact used in symptomatic treatment of early PD patients was: anterior -1.1±1.7 mm, lateral 10.7±1.7 mm and superior -3.3±2.5 mm (anterior and posterior commissure coordinates). This location is statistically no different (0.77 mm, p>0.05) than the optimal contact used in the treatment of 47 advanced PD patients. The perioperative adverse events in this trial of subjects with early stage PD are comparable with those reported for STN-DBS in advanced PD. The active contact position used in early PD is not significantly different from that used in late stage disease. This is the first report of the operative experience from a randomised, surgical versus best medical therapy trial for the early treatment of PD.

  2. The Role of the Right Hemisphere in Speech Act Comprehension

    Science.gov (United States)

    Holtgraves, Thomas

    2012-01-01

    In this research the role of the RH in the comprehension of speech acts (or illocutionary force) was examined. Two split-screen experiments were conducted in which participants made lexical decisions for lateralized targets after reading a brief conversation remark. On one-half of the trials the target word named the speech act performed with the…

  3. Expectations and experiences of investigators and parents involved in a clinical trial for Duchenne/Becker muscular dystrophy.

    Science.gov (United States)

    Peay, Holly L; Tibben, Aad; Fisher, Tyler; Brenna, Ethan; Biesecker, Barbara B

    2014-02-01

    The social context of rare disease research is changing, with increased community engagement around drug development and clinical trials. This engagement may benefit patients and families but may also lead to heightened trial expectations and therapeutic misconception. Clinical investigators are also susceptible to harboring high expectations. Little is known about parental motivations and expectations for clinical trials for rare pediatric disorders. We describe the experience of parents and clinical investigators involved in a phase II clinical trial for Duchenne and Becker muscular dystrophy: their expectations, hopes, motivations, and reactions to the termination of the trial. This qualitative study was based on interviews with clinical investigators and parents of sons with Duchenne and Becker muscular dystrophy (DBMD) who participated in the phase IIa or IIb ataluren clinical trial in the United States. Interviews were transcribed and coded for thematic analysis. Participants were 12 parents of affected boys receiving active drug and 9 clinical investigators. High trial expectations of direct benefit were reported by parents and many clinicians. Investigators described monitoring and managing parents' expectations; several worried about their own involvement in increasing parents' expectations. Most parents were able to differentiate their expectations from their optimistic hopes for a cure. Parents' expectations arose from other parents, advocacy organizations, and the sponsor. All parents reported some degree of clinical benefit to their children. Secondary benefits were hopefulness and powerful feelings associated with active efforts to affect the disease course. Parents and clinical investigators reported strong, close relationships that were mutually important. Parents and clinicians felt valued by the sponsor for the majority of the trial. When the trial abruptly stopped, they described loss of engagement, distress, and feeling unprepared for the

  4. Experience sampling-based personalized feedback and positive affect: a randomized controlled trial in depressed patients.

    Directory of Open Access Journals (Sweden)

    Jessica A Hartmann

    Full Text Available Positive affect (PA plays a crucial role in the development, course, and recovery of depression. Recently, we showed that a therapeutic application of the experience sampling method (ESM, consisting of feedback focusing on PA in daily life, was associated with a decrease in depressive symptoms. The present study investigated whether the experience of PA increased during the course of this intervention.Multicentre parallel randomized controlled trial. An electronic random sequence generator was used to allocate treatments.University, two local mental health care institutions, one local hospital.102 pharmacologically treated outpatients with a DSM-IV diagnosis of major depressive disorder, randomized over three treatment arms.Six weeks of ESM self-monitoring combined with weekly PA-focused feedback sessions (experimental group; six weeks of ESM self-monitoring combined with six weekly sessions without feedback (pseudo-experimental group; or treatment as usual (control group.The interaction between treatment allocation and time in predicting positive and negative affect (NA was investigated in multilevel regression models.102 patients were randomized (mean age 48.0, SD 10.2 of which 81 finished the entire study protocol. All 102 patients were included in the analyses. The experimental group did not show a significant larger increase in momentary PA during or shortly after the intervention compared to the pseudo-experimental or control groups (χ2(2 = 0.33, p = .846. The pseudo-experimental group showed a larger decrease in NA compared to the control group (χ2(1 = 6.29, p =.012.PA-focused feedback did not significantly impact daily life PA during or shortly after the intervention. As the previously reported reduction in depressive symptoms associated with the feedback unveiled itself only after weeks, it is conceivable that the effects on daily life PA also evolve slowly and therefore were not captured by the experience sampling procedure

  5. Phase-II trials in osteosarcoma recurrences: A systematic review of past experience.

    Science.gov (United States)

    Omer, Natacha; Le Deley, Marie-Cécile; Piperno-Neumann, Sophie; Marec-Berard, Perrine; Italiano, Antoine; Corradini, Nadège; Bellera, Carine; Brugières, Laurence; Gaspar, Nathalie

    2017-04-01

    The most appropriate design of Phase-II trials evaluating new therapies in osteosarcoma remains poorly defined. To study consistency in phase-II clinical trials evaluating new therapies for osteosarcoma recurrences with respect to eligibility criteria, response assessment, end-points, statistical design and reported results. Systematic review of clinical trials registered on clinicaltrials.gov, clinicaltrialsregister.eu and French National Cancer Institute website or referenced in PubMed and American Society of Clinical Oncology websites, between 2003 and 2016, using the following criteria: (osteosarcoma OR bone sarcoma) AND (Phase-II). Among the 99 trials identified, 80 were Phase-II, 17 I/II and 2 II/III, evaluating mostly targeted therapy (n = 40), and chemotherapy alone (n = 26). Results were fully (n = 28) or partially (abstract, n = 6) published. Twenty-four trials were dedicated to osteosarcoma, 22 had an osteosarcoma stratum. Twenty-eight out of 99 trials refer to the age range observed at recurrence (28%). Overall, 65 trials were run in multicentre settings, including 17 international trials. Only 9 trials were randomised. The primary end-point was tumour response in 71 trials (response rate, n = 40 or best response, n = 31), with various definitions (complete + partial ± minor response and stable disease), mainly evaluated with RECIST criteria (n = 69); it was progression-free survival in 24 trials and OS in 3. In single-arm trials evaluating response rate, the null hypothesis tested (when available, n = 12) varied from 5% to 25%. No robust historical data can currently be derived from past efficacy Phase-II trials. There is an urgent need to develop international randomised Phase-II trials across all age ranges with standardised primary end-point. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. Deviant bodies, stigmatized identities, and racist acts: examining the experiences of African-American gamers in Xbox Live

    Science.gov (United States)

    Gray, K. L.

    2012-12-01

    The purpose of this article is to illustrate how minority gamers, particularly African-American males, are subject to the label of deviant within the virtual gaming community of Xbox Live. They are labeled deviant based on the stigma of their physical identity - blackness, through a process of linguistic profiling. By employing virtual ethnography, the author identifies a process that leads to racism based on how the black gamer sounds within the space. The act of racism emerges through a process involving questioning, provoking, instigating, and ultimately racism. Many black gamers have normalized these racist experiences and have accepted the label of deviant placed upon their bodies.

  7. Randomized Clinical Trial of Cognitive Behavioral Therapy (CBT) versus Acceptance and Commitment Therapy (ACT) for Mixed Anxiety Disorders

    Science.gov (United States)

    Arch, Joanna J.; Eifert, Georg H.; Davies, Carolyn; Vilardaga, Jennifer C. Plumb; Rose, Raphael D.; Craske, Michelle G.

    2012-01-01

    Objective: Randomized comparisons of acceptance-based treatments with traditional cognitive behavioral therapy (CBT) for anxiety disorders are lacking. To address this gap, we compared acceptance and commitment therapy (ACT) to CBT for heterogeneous anxiety disorders. Method: One hundred twenty-eight individuals (52% female, mean age = 38, 33%…

  8. Randomized Clinical Trial of Cognitive Behavioral Therapy (CBT) versus Acceptance and Commitment Therapy (ACT) for Mixed Anxiety Disorders

    Science.gov (United States)

    Arch, Joanna J.; Eifert, Georg H.; Davies, Carolyn; Vilardaga, Jennifer C. Plumb; Rose, Raphael D.; Craske, Michelle G.

    2012-01-01

    Objective: Randomized comparisons of acceptance-based treatments with traditional cognitive behavioral therapy (CBT) for anxiety disorders are lacking. To address this gap, we compared acceptance and commitment therapy (ACT) to CBT for heterogeneous anxiety disorders. Method: One hundred twenty-eight individuals (52% female, mean age = 38, 33%…

  9. The Myth of Free and Barrier-Free Access: India's Right to Education Act--Private Schooling Costs and Household Experiences

    Science.gov (United States)

    Srivastava, Prachi; Noronha, Claire

    2016-01-01

    We examine relative household costs and experiences of accessing private and government schooling under India's "Right of Children to Free and Compulsory Education Act, 2009" in the early implementation phase. The Act deems that no child should incur any fee, charges, or expenses in accessing schooling. Private schools are mandated to…

  10. Accuracy of effect size estimates from published psychological experiments involving multiple trials.

    Science.gov (United States)

    Brand, Andrew; Bradley, M T; Best, Lisa A; Stoica, George

    2011-01-01

    The reporting of exaggerated effect size estimates may occur either through researchers accepting statistically significant results when power is inadequate and/or from repeated measures approaches aggregating, averaging multiple items, or multiple trials. Monte-Carlo simulations with input of a small, medium, or large effect size were conducted on multiple items or trials that were either averaged or aggregated to create a single dependent measure. Alpha was set at the .05 level, and the trials were assessed over item or trial correlations ranging from 0 to 1. Simulations showed a large increase in observed effect size averages and the power to accept these estimates as statistically significant increased over numbers of trials or items. Overestimation effects were mitigated as correlations between trials increased but still remained substantial in some cases. The implications of these findings for meta-analyses and different research scenarios are discussed.

  11. The Juggling Act: A Phenomenological Study of Gifted and Talented Girls' Experiences with Facebook

    Science.gov (United States)

    Price, Eunice; Wardman, Janna; Bruce, Toni; Millward, Pam

    2016-01-01

    Facebook is a frequently accessed social networking site with more than one billion active users worldwide. Although there are numerous studies on its impact on teenagers, none have investigated its impact on gifted and talented girls. This study's aim was to understand the social media experiences of talented female student leaders. A qualitative…

  12. Affordable Care Act Qualified Health Plan Enrollment for AIDS Drug Assistance Program Clients: Virginia's Experience and Best Practices.

    Science.gov (United States)

    McManus, Kathleen A; Rodney, Robert C; Rhodes, Anne; Bailey, Steven; Dillingham, Rebecca

    2016-09-01

    With the implementation of the Affordable Care Act (ACA) in 2014, many safety net resources, including state AIDS Drug Assistance Programs (ADAPs), incorporated ACA Qualified Health Plans (QHPs) into their healthcare delivery model. This article highlights the benefits of the ACA for persons living with HIV. It also describes the range of strategies employed by state ADAPs to enroll patients in QHPs. The Virginia ADAP ACA implementation experience is described to illustrate one ADAP's shift to purchasing QHPs in addition to providing direct medications. Virginia ADAP is in a Medicaid nonexpansion state and funds the full costs of the QHP premiums, deductibles, and medication copayments. Virginia's experience is applicable to other Medicaid nonexpansion states and to state ADAPs in Medicaid expansion states, who are looking for options for their Medicaid ineligible clients. This article provides practical details of Virginia ADAP's ACA implementation as well as insights and best practices at both the state and clinic level.

  13. Recruitment and training for home hemodialysis: experience and lessons from the Nocturnal Dialysis Trial.

    Science.gov (United States)

    Pipkin, Mary; Eggers, Paul W; Larive, Brett; Rocco, Michael V; Stokes, John B; Suri, Rita S; Lockridge, Robert S

    2010-09-01

    We assessed perceived barriers and incentives to home hemodialysis and evaluated potential correlates with the duration of home hemodialysis training. Surveys were sent to the principal investigator and study coordinator for each clinical center in the Frequent Hemodialysis Network Nocturnal Trial. Baseline data were obtained on medical comorbidities, cognitive and physical functioning, sessions required for home hemodialysis training, and costs of home renovations. The most commonly perceived barriers included lack of patient motivation, unwillingness to change from in-center modality, and fear of self-cannulation. The most common incentives were greater scheduling flexibility and reduced travel time. The median costs for home renovations varied between $1191 and $4018. The mean number of home hemodialysis training sessions was 27.7 +/- 10.4 (11-59 days). Average training time was less for patients with experience in either self-care or both self-care and cannulation. The number of training sessions was unrelated to the score on the Modified Mini Mental Status or Trailmaking B tests or patient's education level. Training time also did not correlate with the SF-36 Physical Function subscale but did with the modified Charlson comorbidity score and older patient age. Lack of patient or family motivation and fear of the dialysis process are surmountable barriers for accepting home hemodialysis as a modality for renal replacement therapy. Formal education and scores on cognitive function tests are not predictors of training time.

  14. Learning from 25 years of experience with the United States clean air act

    Energy Technology Data Exchange (ETDEWEB)

    Schulze, R.H. [Trinity Consultants Incorporated, Dallas, TX (United States)

    1995-12-31

    Twenty-five years ago, the United States embarked on a quest to attain clean air. President Nixon, in signing the Clean Air Act of 1970, defined clean air as the objective for the `70s. Although enormous progress has been made, much remains to be done. Newly constructed industry is quite clean, but many older facilities continue to operate with antiquated controls. Significant advances have been made in cleaning up the emissions from new automobiles, but two factors have impaired progress. First, cars last longer than they did in 1970, so the average age of the fleet has increased. Second, travel has increased as people have moved to the suburbs. Thus, the emission decreases from clean cars have not been as great as expected. This presentation will address some of the lessons learned from the efforts in the United States to implement clean air programs. In a large number of countries, excessively elaborate studies have been substituted for action programs. Since much is now known about air quality, fairly brief studies can define programs that should be undertaken. What may take longer is developing public support and enthusiasm for improved air quality. In most cases, it is desirable to reduce spending on studies and increase spending on devising and implementing plans, as well as effectively communicating the necessary changes to the public. Balanced spending on studies- and action programs is essential to a sound air quality control program. (author)

  15. Young women's attitudes towards, and experiences of, long-acting reversible contraceptives.

    Science.gov (United States)

    Bracken, Jennifer; Graham, Cynthia A

    2014-08-01

    To identify factors involved in women's decisions to choose particular contraceptive methods and more specifically, incentives and disincentives to use three long-acting reversible contraceptive (LARC) methods: injectables, implants, and intrauterine devices/systems (IUDs/IUSs). A total of 502 women aged 18 to 30 completed a cross-sectional online questionnaire. The three most important factors in choosing a contraceptive method were: high efficacy at preventing pregnancy, protection against sexually transmitted infections, and non-interference with sexual intercourse. The most common incentives for LARC use were the high efficacy and long duration of action. Disincentives included the possibility of irregular bleeding and concerns about effects on fertility; fear of needles and pain was a particular disincentive for IUD/IUS use. Only 93 (18%) of the participants reported ever having used a LARC. Reported disincentives to LARC use (e.g., concern about effects on future fertility) indicated that many young women hold inaccurate beliefs about these methods. The relatively high proportions of women who held neutral attitudes about LARCs (21-40%, depending on the method) highlight the importance of education and contraceptive counselling to improve knowledge about the advantages of these methods.

  16. Retrocausation acting in the single-electron double-slit interference experiment

    Science.gov (United States)

    Hokkyo, Noboru

    The single electron double-slit interference experiment is given a time-symmetric interpretation and visualization in terms of the intermediate amplitude of transition between the particle source and the detection point. It is seen that the retarded (causal) amplitude of the electron wave expanding from the source shows an advanced (retrocausal) bifurcation and merging in passing through the double-slit and converges towards the detection point as if guided by the advanced (retrocausal) wave from the detected electron. An experiment is proposed to confirm the causation-retrocausation symmetry of the electron behavior by observing the insensitivity of the interference pattern to non-magnetic obstacles placed in the shadows of the retarded and advanced waves appearing on the rear and front sides of the double-slit.

  17. Randomized, placebo controlled trial of withdrawal of slow-acting antirheumatic drugs and of observer bias in rheumatoid arthritis

    DEFF Research Database (Denmark)

    Gøtzsche, P C; Hansen, M; Stoltenberg, M;

    1996-01-01

    Patients with rheumatoid arthritis, in stable treatment with methotrexate, penicillamine, or sulfasalazine, were randomized in a double-blind fashion either to continuation of their usual treatment or to placebo. 112 patients were included; 52 patients who refused participation had no more severe...... between the observers' evaluations of the joints. The effect of slow-acting antirheumatic drugs was unequivocal and no observer bias occurred....

  18. The Work Experiences of Community Health Professionals: Implications for the Continued Rollout of the Affordable Care Act.

    Science.gov (United States)

    Rodriguez, Hector P; Ramirez, Jeremy C

    2015-01-01

    State health reform (Patient Protection and Affordable Care Act [ACA]) policies may impact the work experiences of community health professionals. We examine the extent to which community health professional work experiences differ depending on state Medicaid expansion and health insurance exchange policies. Public Health Workforce Interests and Needs Survey (PH WINS) (2014) responses from public health nurses, community health workers, health educators, and other public health professionals were merged with state ACA Medicaid expansion and health insurance exchange operations data. We used multivariate regression to examine the extent to which community health professionals in states without Medicaid expansion, or expansion states without a state-run health insurance exchange, reported lower-quality work experiences and less leadership support than did community health professionals working in Medicaid expansion states with state-run health insurance exchanges, controlling for worker characteristics. Local and state health departments (SHD) in 37 states. 10,246 state health department and 6450 local health department (LHD) workers. Work satisfaction (job, organization, pay, and job security), quality of work experiences, leadership support, and impact of the ACA on work. In adjusted analyses, LHD community health professionals in states without Medicaid expansion reported worse experiences of leadership support (β = -9.83; P < .05). LHD community health professionals in Medicaid expansion states without state-run health insurance exchange operations reported lower-quality work experiences (β = -13.06; P < .01), less leadership support (β = -11.52; P < .001), and perceived greater impacts of the ACA on their work (β = 9.18; P < .001) than did LHD community health professionals in expansion states with state-run health insurance exchanges. Less state control over health insurance exchange operations or state inaction with respect to Medicaid expansion may

  19. Employing a Mock Trial in a Criminology Course: An Applied Learning Experience.

    Science.gov (United States)

    Shepelak, Norma J.

    1996-01-01

    Recounts a criminology class exercise that consisted of staging a mock trial using the murders from Truman Capote's "In Cold Blood" as source material. Students research the case and role play various lawyers, jury members, and witnesses. Identifies and discusses four educational objectives attainable through the staging of mock trials. (MJP)

  20. Employing a Mock Trial in a Criminology Course: An Applied Learning Experience.

    Science.gov (United States)

    Shepelak, Norma J.

    1996-01-01

    Recounts a criminology class exercise that consisted of staging a mock trial using the murders from Truman Capote's "In Cold Blood" as source material. Students research the case and role play various lawyers, jury members, and witnesses. Identifies and discusses four educational objectives attainable through the staging of mock trials. (MJP)

  1. Nazi Medical Experiment Report: Evidence from the Nuremberg Medical Trial. Teaching with Documents.

    Science.gov (United States)

    Haverkamp, Beth; Schamel, Wynell

    1995-01-01

    Describes the historical background to the Nuremberg War Trials. Asserts that there is a wealth of evidence in the National Archives documenting atrocities committed by the Nazis. Presents primary source documents used in the Trials and provides seven suggested teaching strategies. (CFR)

  2. Young People's Experiences of Participation in Clinical Trials : Reasons for Taking Part

    NARCIS (Netherlands)

    Luchtenberg, Malou; Maeckelberghe, Els; Locock, Louise; Powell, Lesley; Verhagen, A. A. Eduard

    2015-01-01

    Given the lack of knowledge about safety and efficacy of many treatments for children, pediatric clinical trials are important, but recruitment for pediatric research is difficult. Little is known about children's perspective on participating in trials. The purpose of this study was to understand th

  3. A New Level A Type IVIVC for the Rational Design of Clinical Trials Toward Regulatory Approval of Generic Polymeric Long-Acting Injectables.

    Science.gov (United States)

    Somayaji, Mahadevabharath R; Das, Debarun; Przekwas, Andrzej

    2016-10-01

    Chronic neuropsychiatric disorders and diabetes mellitus affect millions of patients and require long-term supervision and expensive medical care. Although repeated drug administration can help manage these diseases, relapses and re-hospitalization owing to patient non-adherence and reduced therapeutic efficacy remain challenging. In response, long-acting injectables, which provide sustained drug release over longer periods at concentrations close to therapeutic ranges, have been proposed. Recent advancements include polymeric long-acting injectables (pLAIs), in which the active pharmaceutical ingredient (API) is encapsulated within U.S. Food and Drug Administration (FDA)-approved biocompatible polymers, such as poly(lactic-co-glycolic acid), or PLGA. Despite significant progress and development in the global pLAI market, FDA guidance for the approval of complex drug products, such as generic pLAIs, is not clearly defined. Although in vitro to in vivo correlation (IVIVC) can facilitate the identification of critical quality attributes (CQAs), drug formulations, and in vitro test platforms for evaluating drug performance in vivo, the application of IVIVC in order to shortlist time- and resource-intensive clinical trials for generic pLAIs has not been reported. Here, we propose a new Level A Type IVIVC that directly correlates the in vitro outcomes, such as drug dissolution, of candidate generic formulations with the clinical characteristics, such as drug absorption, of a reference listed drug (RLD), to help identify the specific generic pLAI formulations with clinical absorptions that are likely to be similar to that of the RLD, thereby reducing the number of clinical trials required for evaluation of clinical bioequivalence (BE). Therefore, the scope of the proposed method is intended only for the rational design of clinical trials, i.e., to shortlist the specific pLAI generic formulations for clinical BE evaluation, and not necessarily to analyze drug performances

  4. The impact of personal and/or close relationship experience on memorable messages about breast cancer and the perceived speech acts of the sender.

    Science.gov (United States)

    Smith, Sandi W; Atkin, Charles; Skubisz, Christine M; Nazione, Samantha; Stohl, Cynthia

    2009-01-01

    Memorable messages and their speech acts (purposes of the messages) can promote protection against breast cancer and guide health behaviors. Participants reported their personal, friends', and relatives' experiences with breast cancer and a memorable message about breast cancer if one came to mind. Those with a memorable message reported its perceived speech acts. Individuals who had personal and friend or relative experience with breast cancer were significantly more likely to recall memorable messages than other respondents. The most frequently perceived speech acts were providing facts, providing advice, and giving hope. This information should be used to form messages in future breast cancer protection campaigns.

  5. "Did the trial kill the intervention?" experiences from the development, implementation and evaluation of a complex intervention

    Directory of Open Access Journals (Sweden)

    Cox Karen

    2011-03-01

    Full Text Available Abstract Background The development, implementation and evaluation of any new health intervention is complex. This paper uses experiences from the design, implementation and evaluation of a rehabilitation programme to shed light on, and prompt discussion around, some of the complexities involved in such an undertaking. Methods Semi-structured interviews were conducted with 15 trial participants and five members of staff at the conclusion of a trial evaluating a rehabilitation programme aimed at promoting recovery after stem cell transplantation. Results This study identified a number of challenges relating to the development and evaluation of complex interventions. The difficulty of providing a standardised intervention that was acceptable to patients was highlighted in the participant interviews. Trial participants and some members of staff found the concept of equipoise and randomisation challenging and there was discord between the psychosocial nature of the intervention and the predominant bio-medical culture in which the research took place. Conclusions A lack of scientific evidence as to the efficacy of an intervention does not preclude staff and patients holding strong views about the benefits of an intervention. The evaluation of complex interventions should, where possible, facilitate not restrict that complexity. Within the local environment where the trial is conducted, acquiescence from those in positions of authority is insufficient; commitment to the trial is required.

  6. GP supervisors' experience in supporting self-regulated learning: a balancing act.

    Science.gov (United States)

    Sagasser, Margaretha H; Kramer, Anneke W M; van Weel, Chris; van der Vleuten, Cees P M

    2015-08-01

    Self-regulated learning is essential for professional development and lifelong learning. As self-regulated learning has many inaccuracies, the need to support self-regulated learning has been recommended. Supervisors can provide such support. In a prior study trainees reported on the variation in received supervisor support. This study aims at exploring supervisors' perspectives. The aim is to explore how supervisors experience self-regulated learning of postgraduate general practitioners (GP) trainees and their role in this, and what helps and hinders them in supervising. In a qualitative study using a phenomenological approach, we interviewed 20 supervisors of first- and third-year postgraduate GP trainees. Supervisors recognised trainee activity in self-regulated learning and adapted their coaching style to trainee needs, occasionally causing conflicting emotions. Supervisors' beliefs regarding their role, trainees' role and the usefulness of educational interventions influenced their support. Supervisors experienced a relation between patient safety, self-regulated learning and trainee capability to learn. Supervisor training was helpful to exchange experience and obtain advice. Supervisors found colleagues helpful in sharing supervision tasks or in calibrating judgments of trainees. Busy practice occasionally hindered the supervisory process. In conclusion, supervisors adapt their coaching to trainees' self-regulated learning, sometimes causing conflicting emotions. Patient safety and entrustment are key aspects of the supervisory process. Supervisors' beliefs about their role and trainees' role influence their support. Supervisor training is important to increase awareness of these beliefs and the influence on their behaviour, and to improve the use of educational instruments. The results align with findings from other (medical) education, thereby illustrating its relevance.

  7. Experiences in conducting multiple community-based HIV prevention trials among women in KwaZulu-Natal, South Africa

    Directory of Open Access Journals (Sweden)

    Moodley Jothi

    2010-04-01

    Full Text Available Abstract Background South Africa, with its scientific capacity, good infrastructure and high HIV incidence rates, is ideally positioned to conduct large-scale HIV prevention trials. The HIV Prevention Research Unit of the South African Medical Research Council conducted four phase III and one phase IIb trials of women-initiated HIV prevention options in KwaZulu-Natal between 2003 and 2009. A total of 7046 women participated, with HIV prevalence between 25% and 45% and HIV incidence ranging from 4.5-9.1% per year. Unfortunately none of the interventions tested had any impact on reducing the risk of HIV acquisition; however, extremely valuable experience was gained, lessons learned and capacity built, while the communities gained associated benefits. Experience Our experience in conducting these trials ranged from setting up community partnerships to developing clinical research sites and dissemination of trial results. Community engagement included setting up community-based research sites with approval from both political and traditional leaders, and developing community advisory groups to assist with the research process. Community-wide education on HIV/sexually transmitted infection prevention, treatment and care was provided to over 90 000 individuals. Myths and misconceptions were addressed through methods such as anonymous suggestion boxes in clinic waiting areas and intensive education and counselling. Attempts were made to involve male partners to foster support and facilitate recruitment of women. Peer educator programmes were initiated to provide ongoing education and also to facilitate recruitment of women to the trials. Recruitment strategies such as door-to-door recruitment and community group meetings were initiated. Over 90% of women enrolled were retained. Community benefits from the trial included education on HIV prevention, treatment and care and provision of ancillary care (such as Pap smears, reproductive health care and

  8. Whole Animal Experiments Should Be More Like Human Randomized Controlled Trials

    OpenAIRE

    2013-01-01

    The quality of reporting of animal studies lags behind that of human randomized controlled trials but a series of additions to the ARRIVE guidelines will help ensure that the standards are comparable.

  9. The Nutritional Balancing Act of a Large Herbivore: An Experiment with Captive Moose (Alces alces L).

    Science.gov (United States)

    Felton, Annika M; Felton, Adam; Raubenheimer, David; Simpson, Stephen J; Krizsan, Sophie J; Hedwall, Per-Ola; Stolter, Caroline

    2016-01-01

    The nutrient balancing hypothesis proposes that, when sufficient food is available, the primary goal of animal diet selection is to obtain a nutritionally balanced diet. This hypothesis can be tested using the Geometric Framework for nutrition (GF). The GF enables researchers to study patterns of nutrient intake (e.g. macronutrients; protein, carbohydrates, fat), interactions between the different nutrients, and how an animal resolves the potential conflict between over-eating one or more nutrients and under-eating others during periods of dietary imbalance. Using the moose (Alces alces L.), a model species in the development of herbivore foraging theory, we conducted a feeding experiment guided by the GF, combining continuous observations of six captive moose with analysis of the macronutritional composition of foods. We identified the moose's self-selected macronutrient target by allowing them to compose a diet by mixing two nutritionally complementary pellet types plus limited access to Salix browse. Such periods of free choice were intermixed with periods when they were restricted to one of the two pellet types plus Salix browse. Our observations of food intake by moose given free choice lend support to the nutrient balancing hypothesis, as the moose combined the foods in specific proportions that provided a particular ratio and amount of macronutrients. When restricted to either of two diets comprising a single pellet type, the moose i) maintained a relatively stable intake of non-protein energy while allowing protein intakes to vary with food composition, and ii) increased their intake of the food item that most closely resembled the self-selected macronutrient intake from the free choice periods, namely Salix browse. We place our results in the context of the nutritional strategy of the moose, ruminant physiology and the categorization of food quality.

  10. The Nutritional Balancing Act of a Large Herbivore: An Experiment with Captive Moose (Alces alces L.

    Directory of Open Access Journals (Sweden)

    Annika M Felton

    Full Text Available The nutrient balancing hypothesis proposes that, when sufficient food is available, the primary goal of animal diet selection is to obtain a nutritionally balanced diet. This hypothesis can be tested using the Geometric Framework for nutrition (GF. The GF enables researchers to study patterns of nutrient intake (e.g. macronutrients; protein, carbohydrates, fat, interactions between the different nutrients, and how an animal resolves the potential conflict between over-eating one or more nutrients and under-eating others during periods of dietary imbalance. Using the moose (Alces alces L., a model species in the development of herbivore foraging theory, we conducted a feeding experiment guided by the GF, combining continuous observations of six captive moose with analysis of the macronutritional composition of foods. We identified the moose's self-selected macronutrient target by allowing them to compose a diet by mixing two nutritionally complementary pellet types plus limited access to Salix browse. Such periods of free choice were intermixed with periods when they were restricted to one of the two pellet types plus Salix browse. Our observations of food intake by moose given free choice lend support to the nutrient balancing hypothesis, as the moose combined the foods in specific proportions that provided a particular ratio and amount of macronutrients. When restricted to either of two diets comprising a single pellet type, the moose i maintained a relatively stable intake of non-protein energy while allowing protein intakes to vary with food composition, and ii increased their intake of the food item that most closely resembled the self-selected macronutrient intake from the free choice periods, namely Salix browse. We place our results in the context of the nutritional strategy of the moose, ruminant physiology and the categorization of food quality.

  11. A Data Management System Integrating Web-based Training and Randomized Trials: Requirements, Experiences and Recommendations.

    Science.gov (United States)

    Muroff, Jordana; Amodeo, Maryann; Larson, Mary Jo; Carey, Margaret; Loftin, Ralph D

    2011-01-01

    This article describes a data management system (DMS) developed to support a large-scale randomized study of an innovative web-course that was designed to improve substance abuse counselors' knowledge and skills in applying a substance abuse treatment method (i.e., cognitive behavioral therapy; CBT). The randomized trial compared the performance of web-course-trained participants (intervention group) and printed-manual-trained participants (comparison group) to determine the effectiveness of the web-course in teaching CBT skills. A single DMS was needed to support all aspects of the study: web-course delivery and management, as well as randomized trial management. The authors briefly reviewed several other systems that were described as built either to handle randomized trials or to deliver and evaluate web-based training. However it was clear that these systems fell short of meeting our needs for simultaneous, coordinated management of the web-course and the randomized trial. New England Research Institute's (NERI) proprietary Advanced Data Entry and Protocol Tracking (ADEPT) system was coupled with the web-programmed course and customized for our purposes. This article highlights the requirements for a DMS that operates at the intersection of web-based course management systems and randomized clinical trial systems, and the extent to which the coupled, customized ADEPT satisfied those requirements. Recommendations are included for institutions and individuals considering conducting randomized trials and web-based training programs, and seeking a DMS that can meet similar requirements.

  12. [Possibility of uterus transplantation trial in Czech Republic - indications, research and clinical experience].

    Science.gov (United States)

    Chmel, Roman; Nováčková, Marta; Pastor, Zlatko; Matěcha, Jan; Čekal, Miloš; Froněk, Jiří

    2017-01-01

    Uterus transplantation is a novel experimental method of female infertility treatment. It is an appropriate treatment modality for women with absolute uterine factor infertility - congenital uterine malformations, absent uterus, hysterectomized women and non-functional uterus.Successful animal studies confirming the safety and efficacy were performed before introduction of uterus transplantation into human medicine. The first clinical trial was performed in 2012-2013 in Gothenburg, Sweden. The first child from the transplanted womb was delivered in 2014. Concerning the promising results of Swedish trial it is essential to perform trials in some other world centers.In 2015 Czech Ministry of Health permitted uterus transplantation trial in cooperation of two Prague hospitals - namely Institute for Clinical and Experimental Medicine and University Hospital Motol. The aim of the Czech trial is to reassert feasibility, efficacy and safety of uterus transplantation in two groups of women - 10 recipients from living and 10 from deceased brain donor. We believe that detailed and precise long-term theoretic and practical preparation and perfectly arranged trial are the main conditions of the successful uterine transplantation survey. The first Czech uterus transplantation was performed in April 30, 2016.Up to December 2016 four transplantations out of planned 20 (2 in living donor and 2 in deceased brain donor arm) were carried out by our team.

  13. INTER-ACT: prevention of pregnancy complications through an e-health driven interpregnancy lifestyle intervention - study protocol of a multicentre randomised controlled trial.

    Science.gov (United States)

    Bogaerts, Annick; Ameye, Lieveke; Bijlholt, Margriet; Amuli, Kelly; Heynickx, Dorine; Devlieger, Roland

    2017-05-26

    Excessive maternal pre-pregnancy and gestational weight gain are related to pregnancy- and birth outcomes. The interpregnancy time window offers a unique opportunity to intervene in order to acquire a healthy lifestyle before the start of a new pregnancy. INTER-ACT is an e-health driven multicentre randomised controlled intervention trial targeting women at high risk of pregnancy- and birth related complications. Eligible women are recruited for the study at day 2 or 3 postpartum. At week 6 postpartum, participants are randomised into the intervention or control arm of the study. The intervention focuses on weight, diet, physical activity and mental well-being, and comprises face-to-face coaching, in which behavioural change techniques are central, and use of a mobile application, which is Bluetooth-connected to a weighing scale and activity tracker. The intervention is rolled out postpartum (4 coaching sessions between week 6 and month 6) and in a new pregnancy (3 coaching sessions, one in each trimester of pregnancy); the mobile app is used throughout the two intervention phases. Data collection includes data from the medical record of the participants (pregnancy outcomes and medical history), anthropometric data (height, weight, waist- and hip circumferences, skinfold thickness and body composition by bio-electrical impedance analysis), data from the mobile app (physical activity and weight; intervention group only) and questionnaires (socio-demographics, breastfeeding, food intake, physical activity, lifestyle, psychosocial factors and process evaluation). Medical record data are collected at inclusion and at delivery of the subsequent pregnancy. All other data are collected at week 6 and month 6 postpartum and every subsequent 6 months until a new pregnancy, and in every trimester in the new pregnancy. Primary outcome is the composite endpoint score of pregnancy-induced hypertension, gestational diabetes mellitus, caesarean section, and large

  14. Understanding involvement in surgical orthopaedic randomized controlled trials: A qualitative study of patient and health professional views and experiences

    Science.gov (United States)

    Horwood, Jeremy; Johnson, Emma; Gooberman-Hill, Rachael

    2016-01-01

    Background Factors influencing patients' motivations for enrolling in, and their experiences of, orthopaedic randomized controlled trials (RCTs) are not fully understood. Less is known about healthcare professionals' (HCP) experiences of RCT involvement. Aim This study investigates patients' and HCPs' views and experiences of RCT participation and delivery to inform the planning of future RCTs. Methods Total hip or knee replacement patients (n = 24) participating in the single-center double-blind APEX RCTs of an intra-operative anesthetic intervention and HCPs (n = 15) involved in trial delivery were interviewed. Data were audio-recorded, transcribed, anonymized and thematically analyzed. Results Although altruistic reasons for RCT participation were common, patients also weighed up demands of the RCT with the potential benefits of taking part, demonstrating the complex and conditional nature of trial participation. HCPs were interested in RCT involvement as a means of contributing towards advances in medical knowledge and also considered the costs and benefits of RCT involvement. Conclusion Patients and HCPs value involvement in RCTs that they see as relevant and of value, while imposing minimum burden. These findings have important implications for the design of methods to recruit patients to RCTs and for planning how an RCT might best interface with HCP clinical commitments. PMID:26772763

  15. Somatisation in primary care: experiences of primary care physicians involved in a training program and in a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Salazar Agustín

    2009-11-01

    Full Text Available Abstract Background A new intervention aimed at managing patients with medically unexplained symptoms (MUS based on a specific set of communication techniques was developed, and tested in a cluster randomised clinical trial. Due to the modest results obtained and in order to improve our intervention we need to know the GPs' attitudes towards patients with MUS, their experience, expectations and the utility of the communication techniques we proposed and the feasibility of implementing them. Physicians who took part in 2 different training programs and in a randomised controlled trial (RCT for patients with MUS were questioned to ascertain the reasons for the doctors' participation in the trial and the attitudes, experiences and expectations of GPs about the intervention. Methods A qualitative study based on four focus groups with GPs who took part in a RCT. A content analysis was carried out. Results Following the RCT patients are perceived as true suffering persons, and the relationship with them has improved in GPs of both groups. GPs mostly valued the fact that it is highly structured, that it made possible a more comfortable relationship and that it could be applied to a broad spectrum of patients with psychosocial problems. Nevertheless, all participants consider that change in patients is necessary; GPs in the intervention group remarked that that is extremely difficult to achieve. Conclusion GPs positively evaluate the communication techniques and the interventions that help in understanding patient suffering, and express the enormous difficulties in handling change in patients. These findings provide information on the direction in which efforts for improving intervention should be directed. Trial registration US ClinicalTrials.gov NCT00130988

  16. Working with Community Health Workers as 'volunteers' in a vaccine trial: practical and ethical experiences and implications.

    Science.gov (United States)

    Angwenyi, Vibian; Kamuya, Dorcas; Mwachiro, Dorothy; Marsh, Vicki; Njuguna, Patricia; Molyneux, Sassy

    2013-04-01

    Community engagement is increasingly emphasized in biomedical research, as a right in itself, and to strengthen ethical practice. We draw on interviews and observations to consider the practical and ethical implications of involving Community Health Workers (CHWs) as part of a community engagement strategy for a vaccine trial on the Kenyan Coast. CHWs were initially engaged as an important network to be informed about the trial. However over time, and in response to community advice, they became involved in trial information sharing and identifying potential participants; thereby taking on roles that overlapped with those of employed fieldworkers (FWs). While CHWs involvement was generally perceived as positive and appreciated, there were challenges in their relations with FWs and other community members, partly related to levels and forms of remuneration. Specifically, payment of CHWs was not as high as for FWs and was based on 'performance'. This extrinsic motivation had the potential to crowd out CHWs intrinsic motivation to perform their pre-existing community roles. CHWs remuneration potentially also contributed to CHWs distorting trial information to encourage community members to participate; and to researchers encouraging CHWs to utilize their social connections and status to increase the numbers of people who attended information giving sessions. Individual consent processes were protected in this trial through final information sharing and consent being conducted by trained clinical staff who were not embedded in study communities. However, our experiences suggest that roles and remuneration of all front line staff and volunteers involved in trials need careful consideration from the outset, and monitoring and discussion over time.

  17. Participant Recruitment and Engagement in Automated eHealth Trial Registration: Challenges and Opportunities for Recruiting Women Who Experience Violence.

    Science.gov (United States)

    Koziol-McLain, Jane; McLean, Christine; Rohan, Maheswaran; Sisk, Rose; Dobbs, Terry; Nada-Raja, Shyamala; Wilson, Denise; Vandal, Alain C

    2016-10-25

    Automated eHealth Web-based research trials offer people an accessible, confidential opportunity to engage in research that matters to them. eHealth trials may be particularly useful for sensitive issues when seeking health care may be accompanied by shame and mistrust. Yet little is known about people's early engagement with eHealth trials, from recruitment to preintervention autoregistration processes. A recent randomized controlled trial that tested the effectiveness of an eHealth safety decision aid for New Zealand women in the general population who experienced intimate partner violence (isafe) provided the opportunity to examine recruitment and preintervention participant engagement with a fully automated Web-based registration process. The trial aimed to recruit 340 women within 24 months. The objective of our study was to examine participant preintervention engagement and recruitment efficiency for the isafe trial, and to analyze dropout through the registration pathway, from recruitment to eligibility screening and consent, to completion of baseline measures. In this case study, data collection sources included the trial recruitment log, Google Analytics reports, registration and program metadata, and costs. Analysis included a qualitative narrative of the recruitment experience and descriptive statistics of preintervention participant engagement and dropout rates. A Koyck model investigated the relationship between Web-based online marketing website advertisements (ads) and participant accrual. The isafe trial was launched on September 17, 2012. Placement of ads in an online classified advertising platform increased the average number of recruited participants per month from 2 to 25. Over the 23-month recruitment period, the registration website recorded 4176 unique visitors. Among 1003 women meeting eligibility criteria, 51.55% (517) consented to participate; among the 501 women who enrolled (consented, validated, and randomized), 412 (82.2%) were

  18. Preoperative airway assessment - experience gained from a multicentre cluster randomised trial and the Danish Anaesthesia Database

    DEFF Research Database (Denmark)

    Nørskov, Anders Kehlet

    2016-01-01

    , using state of the art methodology, in order to test the clinical impact of using the SARI for preoperative airway assessment compared with a clinical judgement based on usual practice for airway assessment. Finally, to test if implementation of the SARI would reduce the proportion of unanticipated...... to the DIFFICAIR trial described in Paper 4. The trial was designed to randomise anaesthesia department to either thorough education in, and subsequent use of the SARI for preoperative airway assessment or to continue usual care. Registration of the SARI in DAD was made mandatory in SARI departments and impossible...... baseline values of the primary outcome used in the DIFFICAIR trial. Paper 1 revealed that 1.86% of all patients who were intubated, but not planned for advanced intubation techniques (e.g. video laryngoscopy), were unanticipated difficult to intubate. However, 75 to 93% of all difficult intubations were...

  19. Up-date on the NeoVitaA Trial: Obstacles, challenges, perspectives, and local experiences.

    Science.gov (United States)

    Meyer, Sascha; Gortner, Ludwig

    2016-09-26

    The aim of the NeoVitaA Trial is to assess the role of postnatal additional high-dose oral vitamin A supplementation for 28 days in reducing Bronchopulmonary dysplasia (BPD) or death in extremely low birth weight (ELBW) infants at 36 weeks postmenstrual age (PMA). All infants (both intervention and control group) will be provided with basic vitamin A (1000 IU/kg/day) in addition to trial intervention.In this short communication, we will give an up-date on obstacles, challenges as well as perspectives and potential solutions when putting into place a multicenter, double-blind, randomized trial in this cohort of extremely susceptible infants.

  20. Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: a study protocol for a randomised trial.

    Science.gov (United States)

    Kallesøe, Karen Hansen; Schröder, Andreas; Wicksell, Rikard K; Fink, Per; Ørnbøl, Eva; Rask, Charlotte Ulrikka

    2016-09-15

    Functional somatic syndromes (FSS) are common in adolescents, characterised by severe disability and reduced quality of life. Behavioural treatments such as acceptance and commitment therapy (ACT) has shown promising results in children and adolescents with FSS, but has focused on specific syndromes such as functional pain. The current study will compare the efficacy of group-based ACT with that of enhanced usual care (EUC) in adolescents with a range of FSS operationalised by the unifying construct of multiorgan bodily distress syndrome (BDS). A total of 120 adolescents aged 15-19 and diagnosed with multiorgan BDS, of at least 12 months duration, will be assessed and randomised to either: (1) EUC: a manualised consultation with a child and adolescent psychiatrist and individualised treatment plan or (2) manualised ACT-based group therapy plus EUC. The ACT programme consists of 9 modules (ie, 27 hours) and 1 follow-up meeting (3 hours). The primary outcome is physical health, assessed by an Short Form Health Survey (SF-36) aggregate score 12 months after randomisation. Secondary outcomes include self-reported symptom severity, symptom interference, depression and anxiety, illness worry, perceived stress and global improvement; as well as objective physical activity and bodily stress response measured by heart rate variability, hair cortisol and inflammatory biomarkers. Process measures are illness perception, illness-related behaviour and psychological flexibility. The study is conducted in accordance with Helsinki Declaration II. Approval has been obtained from the Science Ethics Committee of the Central Denmark Region and the Danish Data Protection. The results will be sought to be published according to the CONSORT statement in peer-reviewed journals. This is one of the first larger randomised clinical trials evaluating the effect of a group-based intervention for adolescents with a range of severe FSS. NCT02346071; Pre-results. Published by the BMJ

  1. Safety profile of Cerebrolysin: clinical experience from dementia and stroke trials.

    Science.gov (United States)

    Thome, J; Doppler, E

    2012-04-01

    The safety of Cerebrolysin has been shown through many years of clinical use, observations from postmarketing surveillance studies, and safety data from randomized, controlled clinical trials. The reported events showed that adverse reactions to Cerebrolysin were generally mild and transient. Most common adverse events included vertigo, agitation and feeling hot. In the controlled clinical trials analyzed for this report, the incidence of adverse events was similar in Cerebrolysin- and placebo-treated groups. Cerebrolysin seems to be safe when used in combination with recombinant tissue-type plasminogen activator or cholinesterase inhibitors such as donepezil or rivastigmine. To our knowledge, Cerebrolysin was not associated with major changes in vital signs or laboratory parameters.

  2. Long acting octreotide in the treatment of advanced hepatocellular cancer and overexpression of somatostatin receptors: Randomized placebo-controlled trial

    Institute of Scientific and Technical Information of China (English)

    D Dimitroulopoulos; D Daskalopoulou; E Paraskevas; D Xinopoulos; K Tsamakidis; A Zisimopoulos; E Andriotis; D Panagiotakos; A Fotopoulou; C Chrysohoou; A Bazinis

    2007-01-01

    AIM: To estimate if and to what extent long acting octreotide (LAR) improves survival and quality of life in patients with advanced hepatocellular carcinoma (HCC).METHODS: A total of 127 cirrhotics, stages A-B, due to chronic viral infections and with advanced HCC, were enrolled in the study. Scintigraphy with 111Indium labeled octreotide was performed in all cases. The patients with increased accumulation of radionuclear compound were randomized to receive either oral placebo only or octreotide/octreotide LAR only as follows: octreotide 0.5mg s.c. Every 8 h for 6 wk, at the end of wk 4-8 octreotide LAR 20 mg I.m. And at the end of wk 12 and every 4 wk octreotide LAR 30mg I.m.. Follow-up was worked out monthly as well as the estimation of quality of life (QLQ-C30 questionnaire). Patients with negative somatostatin receptors (SSTR) detection were followed up in the same manner.RESULTS: Scintigraphy demonstrated SSTR in 61 patients. Thirty were randomized to receive only placebo and 31 only octreotide. A significantly higher survival time was observed for the octreotide group (49±6 wk)as compared to the control group (28±1 wk) and to the SSTR negative group (28±2 wk), LR=20.39, df=2,P<0.01. The octreotide group presented 68.5% lower hazard ratio [95% CI (47.4%-81.2%)]. During the first year, a 22%, 39% and 43% decrease in the QLQ-C30 score was observed in each group respectively.CONCLUSION: The proposed therapeutic approach has shown to improve the survival and quality of life in SSTR positive patients with advanced HCC.

  3. Can Culture Act as an Enabler to Innovation? Exploring the Germany-Ontario Experience Regarding the Introduction of Green Energy

    Directory of Open Access Journals (Sweden)

    Bill Irwin

    2015-02-01

    Full Text Available This paper explores the role that societal culture may play in terms of acting as an inhibitor or enabler when creating conditions conducive to innovative enterprise. To further understanding of this concept, the paper's authors explore different cultural influences and traditions of the country of Germany and the Canadian province of Ontario against the backdrop of the introduction of a government green energy policy and how local business reacts to new opportunities forthcoming from this shift in policy direction. The authors contend that the current Ontario psyche has contributed to an overall cultural drag on innovative activities. They demonstrate that in no place is this cultural impact more evident than the apparent lack of home-grown innovative activity surrounding green energy entrepreneurship; where, in spite of progressive and favourable provincial government policy, continued manufacturing growth is led by offshore companies The Ontario experience is in sharp contrast to current and historical German activity, when it comes to local innovation and advances in green energy. While Germany officially enacted their green energy act at the turn of the last century, experts agree that the German tenure with going green is in fact 35 to 40 years in the making. Although it has been contended that unique historical conditions such as postwar reconstruction and the reunification of the former East and West Germany have been significant contributing factors to Germany's embracing of sustainable energy, the authors of this paper contend that cultural factors such as the German sense of naturfreund; an overwhelming sense of being a nature-lover, may also play a significant role. In their exploration the authors build upon Hofstede's cultural dimension theory unpacking specific cultural components, as they compare actions and responses made by German and Ontarian policy-makers and business decision-makers.

  4. Small-scale medical waste incinerators: experiences and trials in South Africa

    CSIR Research Space (South Africa)

    Rogers, DEC

    2006-01-01

    Full Text Available incineration units. The trials showed that all of the units could be used to render medical waste non-infectious, and to destroy syringes or render needles unsuitable for reuse. Emission loads from the incinerators are higher than large-scale commercial...

  5. Reconciling research and implementation in micro health insurance experiments in India: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Doyle Conor

    2011-10-01

    Full Text Available Abstract Background Microinsurance or Community-Based Health Insurance is a promising healthcare financing mechanism, which is increasingly applied to aid rural poor persons in low-income countries. Robust empirical evidence on the causal relations between Community-Based Health Insurance and healthcare utilisation, financial protection and other areas is scarce and necessary. This paper contains a discussion of the research design of three Cluster Randomised Controlled Trials in India to measure the impact of Community-Based Health Insurance on several outcomes. Methods/Design Each trial sets up a Community-Based Health Insurance scheme among a group of micro-finance affiliate families. Villages are grouped into clusters which are congruous with pre-existing social groupings. These clusters are randomly assigned to one of three waves of implementation, ensuring the entire population is offered Community-Based Health Insurance by the end of the experiment. Each wave of treatment is preceded by a round of mixed methods evaluation, with quantitative, qualitative and spatial evidence on impact collected. Improving upon practices in published Cluster Randomised Controlled Trial literature, we detail how research design decisions have ensured that both the households offered insurance and the implementers of the Community-Based Health Insurance scheme operate in an environment replicating a non-experimental implementation. Discussion When a Cluster Randomised Controlled Trial involves randomizing within a community, generating adequate and valid conclusions requires that the research design must be made congruous with social structures within the target population, to ensure that such trials are conducted in an implementing environment which is a suitable analogue to that of a non-experimental implementing environment.

  6. Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate: post-hoc analyses of a randomized, double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Fu Dong-Jing

    2011-05-01

    Full Text Available Abstract Background Paliperidone palmitate is a long-acting injectable atypical antipsychotic for the acute and maintenance treatment of adults with schizophrenia. The recommended initiation dosing regimen is 234 mg on Day 1 and 156 mg on Day 8 via intramuscular (deltoid injection; followed by 39 to 234 mg once-monthly thereafter (deltoid or gluteal. These post-hoc analyses addressed two commonly encountered clinical issues regarding the initiation dosing: the time to onset of efficacy and the associated tolerability. Methods In a 13-week double-blind trial, 652 subjects with schizophrenia were randomized to paliperidone palmitate 39, 156, or 234 mg (corresponding to 25, 100, or 150 mg equivalents of paliperidone, respectively or placebo (NCT#00590577. Subjects randomized to paliperidone palmitate received 234 mg on Day 1, followed by their randomized fixed dose on Day 8, and monthly thereafter, with no oral antipsychotic supplementation. The onset of efficacy was defined as the first timepoint where the paliperidone palmitate group showed significant improvement in the Positive and Negative Syndrome Scale (PANSS score compared to placebo (Analysis of Covariance [ANCOVA] models and Last Observation Carried Forward [LOCF] methodology without adjusting for multiplicity using data from the Days 4, 8, 22, and 36 assessments. Adverse event (AE rates and relative risks (RR with 95% confidence intervals (CI versus placebo were determined. Results Paliperidone palmitate 234 mg on Day 1 was associated with greater improvement than placebo on Least Squares (LS mean PANSS total score at Day 8 (p = 0.037. After the Day 8 injection of 156 mg, there was continued PANSS improvement at Day 22 (p ≤ 0.007 vs. placebo and Day 36 (p Conclusions Significantly greater symptom improvement was observed by Day 8 with paliperidone palmitate (234 mg on Day 1 compared to placebo; this effect was maintained after the 156 mg Day 8 injection, with a trend towards a dose

  7. Participation of women in HIV clinical trials: the IPEC-FIOCRUZ experience

    Directory of Open Access Journals (Sweden)

    Lake JE

    2011-07-01

    Full Text Available Jordan E Lake1, Ruth K Friedman2, Cynthia B Cunha2, Sandra W Cardoso2, Valdilea G Veloso2, Judith S Currier1, Beatriz Grinsztejn21Division of Infectious Diseases, University of California at Los Angeles, Los Angeles, CA, USA; 2Fundação Oswaldo Cruz – Instituto de Pesquisa Clínica Evandro Chagas/IPEC, Rio de Janeiro, State of Rio de Janeiro, BrazilBackground: Fifty percent of people living with human immunodeficiency virus (HIV or acquired immunodeficiency syndrome (AIDS worldwide are female. In Brazil, for example, 240,000 women are infected with HIV, rates of infection in women have increased over the last two decades, and addressing HIV prevention and treatment for women at risk for, or living with, HIV/AIDS remains a challenge. To better address the needs of women living with HIV in Brazil, the Instituto de Pesquisa Clínica Evandro Chagas – Fundação Oswaldo Cruz (IPEC-FIOCRUZ HIV Women’s Cohort was established in 1996 to study the natural history of women seeking HIV care. This analysis describes the characteristics of women in the cohort who participated in HIV clinical trials between 1999 and 2008.Methods: A total of 736 Women’s Cohort participants were in active follow-up and 665 participants from the Women’s Cohort were included in univariable and multivariable analyses to determine socioeconomic and sociodemographic factors associated with women’s participation in HIV clinical trials at our site.Results: Of the complete cohort, 23% participated in a clinical trial between January 1999 and July 2008. Odds of participation decreased for women who were younger than 35 years old, currently employed, had an HIV-positive sexual partner, and/or who reported a lifetime history of illicit drug use. Alternatively, the odds of participation increased for women who had more than 8 years of formal education, were living independently, and/or were married or cohabitating.Conclusion: The rate of participation in HIV clinical trials by

  8. Preoperative airway assessment - experience gained from a multicentre cluster randomised trial and the Danish Anaesthesia Database

    DEFF Research Database (Denmark)

    Nørskov, Anders Kehlet

    2016-01-01

    difficult intubation compared with usual care for airway assessment. This thesis is based on data from the Danish Anaesthesia Database (DAD). Paper 1 presents an observational cohort study on 188,064 patients who underwent tracheal intubation from 2008 to 2011. Data on the anaesthesiologists' preoperative...... to the DIFFICAIR trial described in Paper 4. The trial was designed to randomise anaesthesia department to either thorough education in, and subsequent use of the SARI for preoperative airway assessment or to continue usual care. Registration of the SARI in DAD was made mandatory in SARI departments and impossible...... in usual care departments. Conditions regarding anticipation of difficulties and actual airway managements were recorded as for Paper 1. DAD data made it possible to estimate an appropriate sample size, considering the between cluster variation, and to construct a stratification variable based on 2011...

  9. Simulation of plume dispersion from single release in Fusion Field Trial-07 experiment

    Science.gov (United States)

    Singh, Sarvesh Kumar; Sharan, Maithili

    2013-12-01

    Accurate description of source-receptor relationship is required for an efficient source reconstruction. This is examined by simulating the dispersion of plumes resulted from the available ten trials of single releases conducted at Fusion Field Trials, Dugway Proving Ground, Utah. The simulation is addressed with an earlier developed IIT (Indian Institute of Technology) dispersion model using the dispersion parameters in terms of measurements of turbulent velocity fluctuations. Simulation is described separately in both stable and unstable conditions, characterizing the peak as well as overall observed concentration distribution. Simulated results are compared with those obtained using AERMOD. With IIT model, peak concentrations are predicted within a factor of two in all the trials. The higher concentrations (>5 × 10-4 g m-3) are well predicted in stable condition and under-predicted (within a factor of two) in unstable condition whereas relatively smaller concentrations (factor of six. The statistical measures for both the models are found well in agreement with the observations.

  10. Close look at the experiences of patients enrolled in a clinical trial of acupuncture treatment for atrial fibrillation in Korea: a qualitative study nested within a randomised controlled trial

    Science.gov (United States)

    Lee, Seung Min Kathy; Park, Jun Hyeong; Yoon, Kang Hyun; Woo, Jong Shin; Lee, Jung Myung; Kim, Jin-Bae; Kim, Weon; Lee, Sanghoon

    2017-01-01

    Objective To explore the experiences of patients with atrial fibrillation (AF) in the context of a prospective, two-parallel-armed, participant-blinded and assessor-blinded sham-controlled randomised trial. Design A nested qualitative study within an ongoing randomised controlled trial to explore acupuncture's antiarrhythmic effects on drug refractory acupuncture in persistent atrial fibrillation (AF) (ACU-AF trial). Participants Participants were recruited using purposeful sampling and a maximum variation strategy with regard to treatment allocation (treatment or control) and protocol completion (completion or non-completion). Setting This was a single-centre in-depth interview qualitative study conducted at a tertiary-level university hospital in Seoul, Republic of Korea. Results Data saturation was reached after 8 participants. Thematic analysis identified that most patients were not aware of their condition until medical check-up; physician referral was the main reason for trial participation, and patients had high expectations regardless of previous acupuncture experiences. Patients tended to depend on their physicians' opinions because they felt helpless of their condition. No one questioned their assigned treatment groups and generally believed acupuncture treatment was different for cardiovascular diseases. A few patients expressed disappointment in the strict and rigid protocols, in which most practitioners refrained from explaining their acupuncture procedures. Conclusions For cardiovascular patients their physician's advice was one of the biggest reasons for enrolling in the acupuncture trial therefore relying on standard recruitment methods may not be effective. Fortunately both real and sham acupuncture groups in our sample were receiving treatment as intended, but in the future, designing a more pragmatic trial (better reflecting clinical settings, expanding the inclusion criteria and using more treatment points) will allow researchers to better

  11. Experiences of patients and professionals participating in the HITS home blood pressure telemonitoring trial: a qualitative study.

    Science.gov (United States)

    Hanley, Janet; Ure, Jenny; Pagliari, Claudia; Sheikh, Aziz; McKinstry, Brian

    2013-05-28

    To explore the experiences of patients and professionals taking part in a randomised controlled trial (RCT) of remote blood pressure (BP) telemonitoring supported by primary care. To identify factors facilitating or hindering the effectiveness of the intervention and those likely to influence its potential translation to routine practice. Qualitative study adopting a qualitative descriptive approach. 25 patients, 11 nurses and 9 doctors who were participating in an RCT of BP telemonitoring. A maximum variation sample of patients from within the trial based on age, sex and deprivation status of the practice was sought. 6 primary care practices in Scotland. Data were collected via taped semistructured interviews. Initial thematic analysis was inductive. Multiple strategies were employed to ensure that the analysis was credible and trustworthy. Prior to the trial, both patients and professionals were reluctant to increase the medication based on single BP measurements taken in the surgery. BP measurements based on multiple electronic readings were perceived as more accurate as a basis for action. Patients using telemonitoring became more engaged in the clinical management of their condition. Professionals reported that telemonitoring challenged existing roles and work practices and increased workload. Lack of integration of telemonitoring data with the electronic health record was perceived as a drawback. BP telemonitoring in a usual care setting can provide a trusted basis for medication management and improved BP control. It increases patients' engagement in the management of their condition, but supporting telemetry and greater patient engagement can increase professional workloads and demand changes in service organisation. Successful service design in practice would have to take account of how additional roles and responsibilities could be realigned with existing work and data management practices. The embedded qualitative study was included in the protocol for

  12. The dermatology acting internship.

    Science.gov (United States)

    Stephens, John B; Raimer, Sharon S; Wagner, Richard F

    2011-07-15

    Acting internships are an important component of modern day medical school curriculum. Several specialties outside of internal medicine now offer acting internship experiences to fourth year medical students. We have found that a dermatology acting internship is a valuable experience for fourth year medical students who are interested in pursuing a residency in dermatology. Our experience with the dermatology acting internship over the 2010-2011 academic year is described.

  13. Fathers' and Mothers' Experiences with Participation in Part C of the Individuals with Disabilities Education Act Early Intervention Process

    Science.gov (United States)

    Baden, Kristin Marie

    2012-01-01

    Part C of the Individuals with Disabilities Education Act (IDEA) includes a provision for states to provide early intervention (EI) for infants and toddlers demonstrating developmental challenges. Limited data identify how parents, and especially fathers, feel about their experiences participating in Part C EI. This study investigated how fathers…

  14. Simulation of plume dispersion of multiple releases in Fusion Field Trial-07 experiment

    Science.gov (United States)

    Pandey, Gavendra; Sharan, Maithili

    2015-12-01

    For an efficient source term estimation, it is important to use an accurate dispersion model with appropriate dispersion parameters. This is examined by simulating the dispersion of plumes resulted from the available multiple releases conducted at Fusion Field Trials, Dugway Proving Ground, Utah. The simulation is carried out with an earlier developed IIT (Indian Institute of Technology) dispersion model using the dispersion parameters in terms of measurements of turbulent velocity fluctuations. Simulation is discussed separately in both stable and unstable conditions in light of (i) plume behavior of observed and predicted concentrations in the form of isopleths, (ii) peak/maximum concentrations and (iii) overall concentration distribution. Simulated results from IIT model are compared with those obtained using AERMOD. Both, IIT model and AERMOD, predicted peak concentrations within a factor of two in all the releases and tracer transport is mostly along the mean wind direction. With IIT model, the higher concentrations are predicted close to observations in all the trials of stable conditions and with in a factor of two in the trials of unstable conditions. However, the relatively smaller concentrations are under-predicted severely in stable conditions and over-predicted in unstable conditions. The AERMOD exhibits the similar prediction of concentrations as in IIT model except slightly over-prediction in stable conditions and under-prediction in unstable conditions. The statistical measures for both the models are found good in agreement with the observations and a quantitative analysis based on F-test shows that the performance from both the models are found to be similar at 5% significance level.

  15. Phytostabilization of a Pb-contaminated mine tailing by various tree species in pot and field trial experiments.

    Science.gov (United States)

    Meeinkuirt, Weeradej; Pokethitiyook, Prayad; Kruatrachue, Maleeya; Tanhan, Phanwimol; Chaiyarat, Rattanawat

    2012-10-01

    The potential of 6 tree species (Leucaena leucocephala, Acacia mangium, Peltophorum pterocarpum, Pterocarpus macrocarpus, Lagerstroemia floribunda, Eucalyptus camaldulensis) for phytoremediation of Pb in sand tailings (total Pb >9850 mg kg(-1)) from KEMCO Pb mine in Kanchanaburi province, Thailand, were investigated employing a pot experiment (3 months) and field trial experiment (12 months). In pot study E. camaldulensis treated with Osmocote fertilizer attained the highest total biomass (15.3 g plant(-1)) followed by P. pterocarpum (12.6 g plant(-1)) and A. mangium (10.8 g plant(-1)) both treated with cow manure. Cow manure application resulted in the highest root Pb accumulation (>10000 mg kg(-1)) in L. floribunda and P. macrocarpus. These two species also exhibited the highest Pb uptake (85-88 mg plant(-1)). Results from field trial also showed that Osmocote promoted the best growth performance in E. camaldulensis (biomass 385.7 g plant(-1), height 141.7 cm) followed by A. mangium (biomass 215.9 g plant(-1), height 102.7 cm), and they also exhibited the highest Pb uptake (600-800 microg plant(-1)). A. mangium with the addition of organic fertilizer was the best option for phytostabilization of Pb-contaminated mine tailing because it retained higher Pb concentration in the roots.

  16. The accountable health care act of Massachusetts: mixed results for an experiment in universal health care coverage.

    Science.gov (United States)

    Norbash, Alexander; Hindson, David; Heineke, Janelle

    2012-10-01

    The affordable health care act of Massachusetts, signed into law in 2006, resulted in 98% of Massachusetts residents' having some form of insurance coverage by 2011, the highest coverage rate for residents of any state in the nation. With a strong economy, a low unemployment rate, a robust health care delivery system, an extremely low number of undocumented immigrants, and a low baseline uninsured rate, Massachusetts was well positioned for such an effort. Ingredients included mandates, the creation of separate insurance vehicles directed to both poverty-level and non-poverty-level residents, and the reallocation of the former free care pool. The mandates included consumer mandates and employer mandates; the consumer mandate applies to all Massachusetts residents at the risk of losing personal state tax exemptions, and the employer mandate applies to all Massachusetts businesses with 10 or more employees at the risk of per employee financial penalties. The insurance vehicles were created with premiums allocated on the basis of ability to pay by income classes. Unexpected effects included escalating taxpayer health care costs, with taxpayers shouldering the burden for the newly insured, continuing escalating health care costs at a rate greater than the national average, overburdening primary caregivers as newly insured sought new primary care gatekeepers in a system with primary caregiver shortages, and deprivation of support to the safety-net hospitals as a result of siphoned commonwealth free care pool funds. This exercise demonstrates specific benefits and shortfalls of the Massachusetts health care reform experiment, given the conditions and circumstances found in Massachusetts at the time of implementation.

  17. High-dose intravenous immunoglobulin in inflammatory myopathies: experience based on controlled clinical trials.

    Science.gov (United States)

    Dalakas, M C

    2003-10-01

    Controlled clinical trials with high-dose intravenous immunoglobulin (IVIg) have been conducted in patients with DM and IBM, but not PM. A double-blind placebo-controlled study in DM patients, resistant or partially responsive to conventional therapies, showed that IVIg is very effective in improving both the muscle strength and the skin rash. The clinical benefit, which was impressive in patients with early disease, was associated with improvement in the muscle cytoarchitecture. Quantitative histological studies in repeated muscle biopsies showed a statistically significant increased in the size of muscle fibers and the number of capillaries with normalization of the capillary diameter. Resolution of the aberrant immunopathological parameters including interception of complement activation products and downregulation of T cells, ICAM-I, VCAM, TGF-beta and MHC-I molecules was also noted. In IBM, IVIg showed marginal, and non statistically significant, improvements in muscle strength. Up to 20% of patients however, demonstrated clinical improvement with increased activities of daily living while certain muscle groups, such as the muscles of swallowing, showed significant improvements compared to placebo implying mild regional benefits. In PM, small uncontrolled series have shown improvements in muscle strength in up to 70% of the IVIg-treated patients. Because PM, as a stand-alone clinical entity, is a very rare disease, completion of controlled trials will be very difficult.

  18. Preoperative airway assessment - experience gained from a multicentre cluster randomised trial and the Danish Anaesthesia Database.

    Science.gov (United States)

    Nørskov, Anders Kehlet

    2016-05-01

    Difficulties with airway management in relation to general anaesthesia have been a challenge for the anaesthesiologist since the birth of anaesthesia. Massive landmark improvements have been made and general anaesthesia is now regarded as a safe procedure. However, rare, difficult airway management still occurs and it prompts increased risk of morbidity and mortality - especially when not anticipated. Several preoperative risk factors for airway difficulties have been identified, yet none have convincing diagnostic accuracy as stand alone tests. Combining several risk factors increase the predictive value of the test and multivariable risk models have been developed. The Simplified Airway Risk Index (SARI) is a predictive model developed for anticipation of a difficult direct laryngoscopy. However, neither the diagnostic accuracy of the SARI nor of any other model has been tested prospectively and compared with existing practice for airway assessment in a randomised trial setting. The first objective of this thesis was to quantify the proportion of unanticipated difficult intubation and difficult mask ventilation in Denmark. The second objective was to design a cluster randomised trial, using state of the art methodology, in order to test the clinical impact of using the SARI for preoperative airway assessment compared with a clinical judgement based on usual practice for airway assessment. Finally, to test if implementation of the SARI would reduce the proportion of unanticipated difficult intubation compared with usual care for airway assessment. This thesis is based on data from the Danish Anaesthesia Database (DAD). Paper 1 presents an observational cohort study on 188,064 patients who underwent tracheal intubation from 2008 to 2011. Data on the anaesthesiologists' preoperative anticipations of airway difficulties was compared with actual airway management conditions, thus enabling an estimation of the proportion of unanticipated difficulties with intubation

  19. Can Facebook Be Used for Research? Experiences Using Facebook to Recruit Pregnant Women for a Randomized Controlled Trial

    Science.gov (United States)

    Adam, Laura M; Manca, Donna P

    2016-01-01

    Background Recruitment is often a difficult and costly part of any human research study. Social media and other emerging means of mass communication hold promise as means to complement traditional strategies used for recruiting participants because they can reach a large number of people in a short amount of time. With the ability to target a specified audience, paid Facebook advertisements have potential to reach future research participants of a specific demographic. This paper describes the experiences of a randomized controlled trial in Edmonton, Alberta, attempting to recruit healthy pregnant women between 8 and 20 weeks’ gestation for participation in a prenatal study. Various traditional recruitment approaches, in addition to paid Facebook advertisements were trialed. Objective To evaluate the effectiveness of paid advertisements on Facebook as a platform for recruiting pregnant women to a randomized controlled trial in comparison with traditional recruitment approaches. Methods Recruitment using traditional approaches occurred for 7 months, whereas Facebook advertisements ran for a total of 26 days. Interested women were prompted to contact the study staff for a screening call to determine study eligibility. Costs associated with each recruitment approach were recorded and used to calculate the cost to recruit eligible participants. Performance of Facebook advertisements was monitored using Facebook Ads Manager. Results Of the 115 women included, 39.1% (n=45) of the women who contacted study staff heard about the study through Facebook, whereas 60.9% (n=70) of them heard about it through traditional recruitment approaches. During the 215 days (~7 months) that the traditional approaches were used, the average rate of interest was 0.3 (0.2) women/day, whereas the 26 days of Facebook advertisements resulted in an average rate of interest of 2.8 (1.7) women/day. Facebook advertisements cost Can $506.91 with a cost per eligible participant of Cad $20.28. In

  20. Preoperative airway assessment - experience gained from a multicentre cluster randomised trial and the Danish Anaesthesia Database

    DEFF Research Database (Denmark)

    Nørskov, Anders Kehlet

    2016-01-01

    Difficulties with airway management in relation to general anaesthesia have been a challenge for the anaesthesiologist since the birth of anaesthesia. Massive landmark improvements have been made and general anaesthesia is now regarded as a safe procedure. However, rare, difficult airway management...... anticipations of airway difficulties was compared with actual airway management conditions, thus enabling an estimation of the proportion of unanticipated difficulties with intubation and mask ventilation. Papers 2 and 3 outline the methodology and the pre-trial calculations and considerations leading...... in usual care departments. Conditions regarding anticipation of difficulties and actual airway managements were recorded as for Paper 1. DAD data made it possible to estimate an appropriate sample size, considering the between cluster variation, and to construct a stratification variable based on 2011...

  1. High sodium causes hypertension: evidence from clinical trials and animal experiments.

    Science.gov (United States)

    Reddy, Vamsi; Sridhar, Arvind; Machado, Roberto F; Chen, Jiwang

    2015-01-01

    Hypertension is a cardiovascular disease affecting approximately one out of every seven people worldwide. High-sodium consumption has been generally accepted as a risk factor for developing hypertension. Today, global sodium consumption greatly exceeds guidelines recommended by all medical institutions. This review synthesizes the data of landmark mammalian and human studies which investigated the role of sodium in the pathogenesis of hypertension, along with modern studies questioning this relationship. Recent studies concerning the potential pathways by which high-sodium concentration induces hypertension were reviewed. Human trials and population studies revealed a strong correlation between high blood pressure and average dietary sodium; and animal studies found a dramatic reduction in vascular function in a variety of mammals treated with high-sodium diets. In spite of a few contrarian studies, we found overwhelming evidence that elevated sodium consumption could cause hypertension.

  2. Continuous 5-fluorouracil infusion plus long acting octreotide in advanced well-differentiated neuroendocrine carcinomas. A phase II trial of the Piemonte Oncology Network

    Directory of Open Access Journals (Sweden)

    Ciuffreda Libero

    2009-11-01

    Full Text Available Abstract Background Well-differentiated neuroendocrine carcinomas are highly vascularized and may be sensitive to drugs administered on a metronomic schedule that has shown antiangiogenic properties. A phase II study was designed to test the activity of protracted 5-fluorouracil (5FU infusion plus long-acting release (LAR octreotide in patients with neuroendocrine carcinoma. Methods Twenty-nine patients with metastatic or locally advanced well-differentiated neuroendocrine carcinoma were treated with protracted 5FU intravenous infusion (200 mg/m2 daily plus LAR octreotide (20 mg monthly. Patients were followed for toxicity, objective response, symptomatic and biochemical response, time to progression and survival. Results Assessment by Response Evaluation Criteria in Solid Tumors (RECIST criteria showed partial response in 7 (24.1%, stable disease in 20 (69.0%, and disease progression in 2 patients. Response did not significantly differ when patients were stratified by primary tumor site and proliferative activity. A biochemical (chromogranin A response was observed in 12/25 assessable patients (48.0%; symptom relief was obtained in 9/15 symptomatic patients (60.0%. There was non significant decrease in circulating vascular epithelial growth factor (VEGF over time. Median time to progression was 22.6 months (range, 2.7-68.5; median overall survival was not reached yet. Toxicity was mild and manageable. Conclusion Continuous/metronomic 5FU infusion plus LAR octreotide is well tolerated and shows activity in patients with well-differentiated neuroendocrine carcinoma. The potential synergism between metronomic chemotherapy and antiangiogenic drugs provides a rationale for exploring this association in the future. Trial registration NCT00953394

  3. Therapist experience and knowledge acquisition in internet-delivered CBT for social anxiety disorder: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Gerhard Andersson

    Full Text Available BACKGROUND: Guided internet-delivered cognitive behavior therapy (ICBT has been tested in several trials on social anxiety disorder (SAD with moderate to large effects. The aims of this study were threefold. First, to compare the effects of ICBT including online discussion forum with a moderated online discussion forum only. Second, to investigate if knowledge about SAD increased following treatment and third to compare the effects of inexperienced versus experienced therapists on patient outcomes. METHODS: A total of 204 participants with a primary diagnosis of SAD were included and randomized to either guided ICBT or the control condition. ICBT consisted of a 9-week treatment program which was guided by either psychology students at MSc level (n = 6 or by licensed psychologists with previous experience of ICBT (n = 7. A knowledge test dealing with social anxiety was administered before and after treatment. Measures of social anxiety and secondary outcomes dealing with general anxiety, depression, and quality of life were administered before and after treatment. In addition, a 1-year follow-up was conducted on the treated individuals. RESULTS: Immediately following treatment, the ICBT group showed superior outcome on the Liebowitz Social Anxiety Scale self-report version with a between group posttreatment Hedges g effect size of g = 0.75. In addition, significant differences on all the secondary outcomes were observed. Gains were well maintained one year later. Knowledge, as assessed by the knowledge test, increased following treatment with little gain in the control group. Therapist experience did not result in different outcomes, but experienced therapists logged in less frequently compared to the inexperienced therapists, suggesting that they needed less time to support patients. DISCUSSION: We conclude that guided ICBT reduce symptoms of SAD, increase knowledge about SAD and that therapist experience does not make a difference

  4. The cost of implementing consumer financial regulations: an analysis of experience with the Truth in Savings Act

    OpenAIRE

    Gregory E. Elliehausen; Barbara R. Lowrey

    1997-01-01

    The Truth in Savings Act mandates that financial institutions disclose certain information about the terms of consumer deposit accounts in specific forms and at specific times. Although many depository institutions provided disclosures of account terms before the act was passed in 1991, most did not satisfy completely all the requirements of the regulation (Regulation DD) adopted by the Federal Reserve Board to implement the law. Thus, the Truth in Savings law likely caused every depository i...

  5. Comparing the clinical-effectiveness and cost-effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: study protocol for a randomised controlled trial

    Science.gov (United States)

    Hayes, Sara; Hogan, Michael; Dowd, Haulie; Doherty, Edel; O'Higgins, Siobhan; Nic Gabhainn, Saoirse; MacNeela, Padraig; Murphy, Andrew W; Kropmans, Thomas; O'Neill, Ciaran; Newell, John; McGuire, Brian E

    2014-01-01

    Introduction Internet-delivered psychological interventions among people with chronic pain have the potential to overcome environmental and economic barriers to the provision of evidence-based psychological treatment in the Irish health service context. While the use of internet-delivered cognitive–behavioural therapy programmes has been consistently shown to have small-to-moderate effects in the management of chronic pain, there is a paucity in the research regarding the effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) programme among people with chronic pain. The current study will compare the clinical-effectiveness and cost-effectiveness of an online ACT intervention with a waitlist control condition in terms of the management of pain-related functional interference among people with chronic pain. Methods and analysis Participants with non-malignant pain that persists for at least 3 months will be randomised to one of two study conditions. The experimental group will undergo an eight-session internet-delivered ACT programme over an 8-week period. The control group will be a waiting list group and will be offered the ACT intervention after the 3-month follow-up period. Participants will be assessed preintervention, postintervention and at a 3-month follow-up. The primary outcome will be pain-related functional interference. Secondary outcomes will include: pain intensity, depression, global impression of change, acceptance of chronic pain and quality of life. A qualitative evaluation of the perspectives of the participants regarding the ACT intervention will be completed after the trial. Ethics and dissemination The study will be performed in agreement with the Declaration of Helsinki and is approved by the National University of Ireland Galway Research Ethics Committee (12/05/05). The results of the trial will be published according to the CONSORT statement and will be presented at conferences and reported in peer

  6. Motivational Interviewing May Improve Exercise Experience for People with Multiple Sclerosis: A Small Randomized Trial

    Science.gov (United States)

    Smith, Douglas C.; Lanesskog, Deirdre; Cleeland, Leah; Motl, Robert; Weikert, Madeline; Dlugonski, Deirdre

    2012-01-01

    People with multiple sclerosis (MS) are likely to benefit from regular exercise, but physical inactivity is more common among people with MS than among the general population. This small randomized study evaluated whether motivational interviewing (MI) affects adherence to and personal experience in an exercise program. Inactive people with MS…

  7. Randomized Controlled Trial of Teaching Methods: Do Classroom Experiments Improve Economic Education in High Schools?

    Science.gov (United States)

    Eisenkopf, Gerald; Sulser, Pascal A.

    2016-01-01

    The authors present results from a comprehensive field experiment at Swiss high schools in which they compare the effectiveness of teaching methods in economics. They randomly assigned classes into an experimental and a conventional teaching group, or a control group that received no specific instruction. Both teaching treatments improve economic…

  8. Randomized Controlled Trial of Teaching Methods: Do Classroom Experiments Improve Economic Education in High Schools?

    Science.gov (United States)

    Eisenkopf, Gerald; Sulser, Pascal A.

    2016-01-01

    The authors present results from a comprehensive field experiment at Swiss high schools in which they compare the effectiveness of teaching methods in economics. They randomly assigned classes into an experimental and a conventional teaching group, or a control group that received no specific instruction. Both teaching treatments improve economic…

  9. Brain stimulation and brain repair--rTMS: from animal experiment to clinical trials--what do we know?

    Science.gov (United States)

    Platz, Thomas; Rothwell, John C

    2010-01-01

    Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method of stimulating the brain that changes excitability at the site of stimulation as well as at distant anatomically connected sites. Since the effects can outlast the period of stimulation for minutes or hours and are thought to be depend, at least in part, on changes in the efficiency of synaptic connections in the cortex, the method has generated much interest as a potential therapeutic intervention in a wide range of neurological and psychiatric conditions. A symposium on brain stimulation and brain recovery was held in Greifswald (Germany) in 2010 to exchange of state-of-the-art knowledge about rTMS effects from animal experiments to clinical trials in conditions such as stroke, Parkinson disease, and depression. There was enormous interest in the effects of rTMS and signs of therapeutic success in mainly small clinical trials. However, it was also clear that some of our models of the effects of rTMS, such as upregulation or downregulation of specific brain areas may need further development if they are to account for all the observations that have been made so far. The results of the symposium are made available by lab reviews of members of the symposium's faculty. This editorial provides an overview.

  10. Design of a study on suboptimal cognitive acts in the diagnostic process, the effect on patient outcomes and the influence of workload, fatigue and experience of physician

    Directory of Open Access Journals (Sweden)

    van der Wal Gerrit

    2009-04-01

    Full Text Available Abstract Background Diagnostic error is an important error type since diagnostic adverse events are regularly judged as being preventable and the consequences are considered to be severe. Existing research often focuses on either diagnostic adverse events or on the errors in diagnostic reasoning. Whether and when an incorrect diagnostic process results in adverse outcomes has not been studied extensively. The present paper describes the design of a study that aims to study the relationship between a suboptimal diagnostic process and patient outcomes. In addition, the role of personal and circumstantial factors on the quality of the diagnostic process will be examined. Methods/Design The research questions were addressed using several data sources. First, the differential diagnosis was assessed concurrently to the diagnostic process. Second, the patient records of 248 patients suffering from shortness of breath were reviewed by expert internists in order to reveal suboptimal cognitive acts and (potential consequences for the patient. The suboptimal cognitive acts were discussed with the treating physicians and classified with the taxonomy of unsafe acts. Third, workload, fatigue and work experience were measured during the physicians work. Workload and fatigue were measured during the physicians shift using the NASA tlx questionnaire on a handheld computer. Physicians participating in the study also answered questions about their work experience. Discussion The design used in this study provides insight into the relationship between suboptimal cognitive acts in the diagnostic process and possible consequences for the patient. Suboptimal cognitive acts in the diagnostic process and its causes can be revealed. Additional measurements of workload, fatigue and experience allow examining the influence of these factors on the diagnostic process. In conclusion, the present design provides a method with which insights in weaknesses of the diagnostic

  11. Can Facebook Be Used for Research? Experiences Using Facebook to Recruit Pregnant Women for a Randomized Controlled Trial.

    Science.gov (United States)

    Adam, Laura M; Manca, Donna P; Bell, Rhonda C

    2016-09-21

    Recruitment is often a difficult and costly part of any human research study. Social media and other emerging means of mass communication hold promise as means to complement traditional strategies used for recruiting participants because they can reach a large number of people in a short amount of time. With the ability to target a specified audience, paid Facebook advertisements have potential to reach future research participants of a specific demographic. This paper describes the experiences of a randomized controlled trial in Edmonton, Alberta, attempting to recruit healthy pregnant women between 8 and 20 weeks' gestation for participation in a prenatal study. Various traditional recruitment approaches, in addition to paid Facebook advertisements were trialed. To evaluate the effectiveness of paid advertisements on Facebook as a platform for recruiting pregnant women to a randomized controlled trial in comparison with traditional recruitment approaches. Recruitment using traditional approaches occurred for 7 months, whereas Facebook advertisements ran for a total of 26 days. Interested women were prompted to contact the study staff for a screening call to determine study eligibility. Costs associated with each recruitment approach were recorded and used to calculate the cost to recruit eligible participants. Performance of Facebook advertisements was monitored using Facebook Ads Manager. Of the 115 women included, 39.1% (n=45) of the women who contacted study staff heard about the study through Facebook, whereas 60.9% (n=70) of them heard about it through traditional recruitment approaches. During the 215 days (~7 months) that the traditional approaches were used, the average rate of interest was 0.3 (0.2) women/day, whereas the 26 days of Facebook advertisements resulted in an average rate of interest of 2.8 (1.7) women/day. Facebook advertisements cost Can $506.91 with a cost per eligible participant of Cad $20.28. In comparison, the traditional approaches

  12. Contraceptive use in women enrolled into preventive HIV vaccine trials: experience from a phase I/II trial in East Africa.

    Directory of Open Access Journals (Sweden)

    Hannah Kibuuka

    Full Text Available BACKGROUND: HIV vaccine trials generally require that pregnant women are excluded from participation, and contraceptive methods must be used to prevent pregnancy during the trial. However, access to quality services and misconceptions associated with contraceptive methods may impact on their effective use in developing countries. We describe the pattern of contraceptive use in a multi-site phase I/IIa HIV Vaccine trial in East Africa (Uganda, Kenya and Tanzania and factors that may have influenced their use during the trial. METHODS: Pregnancy prevention counseling was provided to female participants during informed consent process and at each study visit. Participants' methods of contraception used were documented. Methods of contraceptives were provided on site. Pregnancy testing was done at designated visits during the trial. Obstacles to contraceptive use were identified and addressed at each visit. RESULTS: Overall, 103 (31.8% of a total of 324 enrolled volunteers were females. Female participants were generally young with a mean age of 29(+/-7.2, married (49.5% and had less than high school education (62.1%. Hormonal contraceptives were the most common method of contraception (58.3% followed by condom use (22.3%. The distribution of methods of contraception among the three sites was similar except for more condom use and less abstinence in Uganda. The majority of women (85.4% reported to contraceptive use prior to screening. The reasons for not using contraception included access to quality services, insufficient knowledge of certain methods, and misconceptions. CONCLUSION: Although hormonal contraceptives were frequently used by females participating in the vaccine trial, misconceptions and their incorrect use might have led to inconsistent use resulting in undesired pregnancies. The study underscores the need for an integrated approach to pregnancy prevention counseling during HIV vaccine trials. TRIAL REGISTRATION: ClinicalTrials

  13. Forensic age estimation in anti-piracy trials in Seychelles: Experiences and challenges faced.

    Science.gov (United States)

    Gunawardena, S A; Liyanage, U A; Weeratna, J B; Mendis, N D N A; Perera, H J M; Jayasekara, R W; Fernando, R

    2017-01-01

    Forensic age estimation (FAE) was conducted using a multifactorial method on thirteen Somali detainees claiming juvenile status during the anti-piracy trials of the Seychelles Supreme Court in 2014/2015. A multidisciplinary team, comprising of four of the authors covering specialties in forensic medicine, forensic odontology and radiology, conducted the FAE using a five-stage protocol. Each detainee was interviewed with an interpreter and examined for disorders affecting dental/skeletal development and for assessment of genital development through Tanner staging. Dental maturity was assessed clinically and radiologically. Eruption stage was assessed using Olze et al. and mandibular third-molar maturity was assessed using Demirjian's classification. Skeletal maturity was assessed from hand-wrist X-rays according to Greulich & Pyle and from CT-clavicle according to Kellinghaus et al. and Schultz et al. Interpretation of findings was done using reference population data from similar ethnic and social backgrounds wherever possible. Final age-ranges were calculated by combining dental and clavicle maturity stages using the regression formula developed by Bassed et al. followed by a 10% correction factor. The team later testified on their findings under cross-examination. The protocol adopted by the authors increased the scientific validity of the findings and was useful in addressing cross-examination queries on exclusion of developmental disorders, ethnic/socioeconomic variability and maintaining chain of custody. Unforeseen jurisdictional and practical limitations were experienced but did not affect the outcome. Combining dental and clavicle developmental data provided the court with a much clearer picture on the likelihood of the detainees' juvenile status which emphasizes the importance of conducting more population studies using combinations of different developmental sites. The authors note that available reference data is mostly from affluent populations whereas

  14. Facilitated patient experience feedback can improve nursing care: a pilot study for a phase III cluster randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background England’s extensive NHS patient survey programme has not fulfilled government promises of widespread improvements in patients’ experiences, and media reports of poor nursing care in NHS hospitals are increasingly common. Impediments to the surveys’ impact on the quality of nursing care may include: the fact that they are not ward-specific, so nurses claim “that doesn’t happen on my ward”; nurses’ scepticism about the relevance of patient feedback to their practice; and lack of prompt communication of results. The surveys’ impact could be increased by: conducting ward-specific surveys; returning results to ward staff more quickly; including patients’ written comments in reports; and offering nurses an opportunity to discuss the feedback. Very few randomised trials have been conducted to test the effectiveness of patient feedback on quality improvement and there have been few, if any, published trials of ward-specific patient surveys. Methods Over two years, postal surveys of recent inpatients were conducted at four-monthly intervals in 18 wards in two NHS Trusts in England. Wards were randomly allocated to Basic Feedback (ward-specific printed patient survey results including patients’ written comments sent to nurses by letter); Feedback Plus (in addition to printed results, ward meetings to discuss results and plan improvements) or Control (no active feedback of survey results). Patient survey responses to questions about nursing care were used to compute wards’ average Nursing Care Scores at each interval. Nurses’ reactions to the patient feedback were recorded. Results Conducting ward-level surveys and delivering ward-specific results was feasible. Ward meetings were effective for engaging nurses and challenging scepticism and patients’ written comments stimulated interest. 4,236 (47%) patients returned questionnaires. Nursing Care Scores improved more for Feedback Plus than Basic Feedback or Control (difference between

  15. Does psychological well-being mediate the association between experiences of acts of offensive behaviour and turnover among care workers? A longitudinal analysis.

    Science.gov (United States)

    Clausen, Thomas; Hogh, Annie; Carneiro, Isabella Gomes; Borg, Vilhelm

    2013-06-01

    To investigate whether the psychological well-being of care workers in the Danish eldercare services mediated the association between experiences of acts of offensive behaviour and actual turnover. Research suggests that experiences of acts of offensive behaviour are associated with risk of turnover. However, little is known about the longitudinal associations between experiences of different types of offensive behaviour (threats, violence, bullying, and unwanted sexual attention) and risk of actual turnover. A prospective cohort study. The study was conducted among employees in the eldercare services in Denmark. Employees aged 55 or more and non-care staff were excluded from the study. Employees who were working in eldercare at baseline (2005) and no longer worked in eldercare at follow-up (2006) were interviewed through questionnaires. Respondents to this questionnaire were coded as cases of turnover (N = 608) and were compared with employees who had not changed jobs during follow-up (N = 4330). Data on experiences of acts of offensive behaviour and well-being were measured at baseline. Data were analysed using logistic regression analysis. Frequent and occasional experiences of bullying and threats and occasional experiences of unwanted sexual attention at baseline entailed a significantly increased risk of turnover at follow-up. Further analyses showed that psychological well-being significantly reduced the risk of turnover and that well-being partially mediated the association between bullying and turnover and fully mediated the association between threats, unwanted sexual attention, and turnover. Prevention of threats, unwanted sexual attention and - especially - bullying may contribute towards improving well-being and reducing turnover among eldercare staff. © 2012 Blackwell Publishing Ltd.

  16. Effect of long-acting testosterone undecanoate treatment on quality of life in men with testosterone deficiency syndrome: a double blind randomized controlled trial

    Institute of Scientific and Technical Information of China (English)

    Seng-Fah Tong; Chirk-Jenn Ng; Boon-Cheok Lee; Verna-KM Lee; Ee-Ming Khoo; Eng-Giap Lee; Hui-Meng Tan

    2012-01-01

    This study aimed to investigate the effect of intramuscular injection of testosterone undecanoate on overall quality of life (QoL) in men with testosterone deficiency syndrome (TDS).A randomized controlled trial over a 12-month period was carried out in 2009.One hundred and twenty men aged 40 years and above with a diagnosis of TDS (serum total testosterone < 12 nmol l-1 and total Aging Male Symptom (AMS) scores ≥ 27) were invited to participate.Interventions comprised intramuscular injection of either placebo or 1000 mg testosterone undecanoate,given at weeks 0,6,18,30 and 42.This paper presents the secondary analysis of QoL changes measured in the scores of Short-Form-12 (SF-12) scale at baseline,weeks 30 and 48 after the first injection.A total of 56/60 and 58/60 men from the active treatment and placebo group,respectively,completed the study.At week 48,before adjusting for baseline differences,the QoL of men in the treatment group improved significantly in five out of the eight domains on SF-12.The physical health composite scores improved 4.0 points from a baseline of 41.9±7.0 in the treatment group compared to 0.8 point from a baseline of 43.7±7.1 in the placebo group (F=3.652,P=0.027).The mental health composite scores improved 4.4 points from a baseline of 37.1±9.0 in the treatment group compared to 1.0 points from a baseline of 37.6±7.9 in the placebo group (F=4.514,P=0.018).After adjusting for baseline differences,significant improvement was observed in mental health composite scores,but not in physical health composite scores.Long-acting testosterone undecanoate significantly improved the mental health component of QoL in men with TDS.

  17. Experience with Subgam, a Subcutaneously Administered Human Normal Immunoglobulin (ClinicalTrials.gov--NCT02247141.

    Directory of Open Access Journals (Sweden)

    Clive Dash

    Full Text Available A multi-centre, non-comparative study examining the efficacy and safety of Subgam, a normal immunoglobulin (IgG given weekly as a rapid subcutaneous infusion to patients with primary immune deficiency (PID, is reported. Also included is a summary of adverse drug reactions associated with the use of marketed Subgam in the UK.50 patients with stable PID on IgG therapy were enrolled: Stage 1 included three infusions with prior IgG product followed by 6 months with Subgam, Stage 2 involved long-term Subgam therapy up to 4 years.Stage 1, 85% of the subjects aged >12 years and 93% of the subjects aged <12 years achieved IgG levels ≥6 and ≥4 g/L, respectively at all observations. There were 3.62 infections/patient/year during Subgam treatment. The most common product-related events were infusion site reactions (50% of patients. Recent post-hoc pharmacokinetics analysis of the post-infusion serum total IgG concentration indicated that the mean dose-normalised incremental IgG AUCτ following intravenous dosing (120.5 g.day/L was 1.64-fold that of the dose-normalised mean incremental IgG AUCτ following subcutaneous dosing (73.6 g.day/L, corresponding to an estimated IgG bioavailability for subcutaneous dosing of 61%. Only 34 post-licensing adverse reactions have been received in 30 patients over a period of 10 years; fourteen were classed as serious as defined by the ICH guidelines on good clinical practice. The most common post-licensing adverse reaction was infusion site reaction (7 reports. There were 7 reports of flu-like symptoms (pyrexia/shivering/rigors/feeling hot or cold, 2 other reports of combined flu-like symptoms and infusion site reactions, 5 reports of generalised skin reactions, and 3 reports of combined infusion site and skin reactions. There were also reports of anaphylaxis (2 reports and 8 other adverse events (including headache. In conclusion, Subgam is effective and well tolerated in the treatment of PID.ClinicalTrials.gov NCT

  18. 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

  19. Preliminary Single-Center Canadian Experience of Human Normothermic Ex Vivo Liver Perfusion: Results of a Clinical Trial.

    Science.gov (United States)

    Bral, M; Gala-Lopez, B; Bigam, D; Kneteman, N; Malcolm, A; Livingstone, S; Andres, A; Emamaullee, J; Russell, L; Coussios, C; West, L J; Friend, P J; Shapiro, A M J

    2017-04-01

    After extensive experimentation, outcomes of a first clinical normothermic machine perfusion (NMP) liver trial in the United Kingdom demonstrated feasibility and clear safety, with improved liver function compared with standard static cold storage (SCS). We present a preliminary single-center North American experience using identical NMP technology. Ten donor liver grafts were procured, four (40%) from donation after circulatory death (DCD), of which nine were transplanted. One liver did not proceed because of a technical failure with portal cannulation and was discarded. Transplanted NMP grafts were matched 1:3 with transplanted SCS livers. Median NMP was 11.5 h (range 3.3-22.5 h) with one DCD liver perfused for 22.5 h. All transplanted livers functioned, and serum transaminases, bilirubin, international normalized ratio, and lactate levels corrected in NMP recipients similarly to controls. Graft survival at 30 days (primary outcome) was not statistically different between groups on an intent-to-treat basis (p = 0.25). Intensive care and hospital stays were significantly more prolonged in the NMP group. This preliminary experience demonstrates feasibility as well as potential technical risks of NMP in a North American setting and highlights a need for larger, randomized studies. © 2016 The American Society of Transplantation and the American Society of Transplant Surgeons.

  20. Feasibility of male hormonal contraception: lessons from clinical trials and animal experiments.

    Science.gov (United States)

    Oduwole, Olayiwola O; Huhtaniemi, Ilpo T

    2014-01-01

    The general interest in the availability of male contraceptives is on the increase across different cultures and ethnic backgrounds, due in part to the fact that men are now willing more than ever, to share the responsibility of family planning. Despite the expression of interest and tremendous advances in research however, a modern male hormonal contraceptive method has remained an elusive goal. Testosterone (T) alone, or in combination with a progestin currently provides the most promising lead to male hormonal contraception. The principle relies on enhanced negative feedback of exogenous T to suppress gonadotropins, thereby blocking the endocrine stimulus for the process of spermatogenesis. A serious drawback is the inconsistent suppression among men of different ethnic backgrounds. This has increased the quest for development to include other nonhormonal methods. In reality many obstacles still have to be overcome before an acceptable method is available. In this review, we highlight recent developments in male hormonal contraceptives methods. Based on our recent findings from animal experiment, we shed light on why the method is not achieving the intended results, and suggest possible ways forward.

  1. Blood Trials: Transfusions, Injections, and Experiments in Africa, 1890-1920.

    Science.gov (United States)

    Sunseri, Thaddeus

    2016-07-01

    From about 1880 to 1920, a culture of medical experimentation promoted blood transfusion as a therapy for severe anemia in Europe, which was applied in German East Africa in 1892 for a case of blackwater fever, a complication of malaria afflicting mainly Europeans. This first case of blood transfusion in Africa, in which an African's blood was transfused into a German official, complicates the dominant narrative that blood transfusions in Africa came only after World War I. Medical researchers moreover experimented with blood serum therapies on human and animal subjects in Europe and Africa, injecting blood of different species, "races" and ethnicities into others to demonstrate parasite transmissibility and to discover vaccines for diseases such as malaria, sleeping sickness, and yellow fever. While research in German colonies is highlighted here, this was a transnational medical culture that crossed borders and oceans. This research is of interest as a possible early pathway for the epidemic spread of HIV and other zoonoses in Africa and the world, which biomedical researchers have identified as emerging in West-Central Africa sometime around the turn of the twentieth century.

  2. Meaning-making matters in product design: users' sensory perceptions and experience evaluations of long-acting vaginal gels and intravaginal rings.

    Science.gov (United States)

    Rosen, Rochelle K; van den Berg, Jacob J; Vargas, Sara E; Senocak, Natali; Shaw, Julia G; Buckheit, Robert W; Smith, Kelley Alison; Guthrie, Kate Morrow

    2015-12-01

    Users' sensory perceptions and experiences of intravaginal products can inform acceptability and adherence. Focusing on the meanings women derive from formulation/device characteristics facilitates developers' design iterations toward optimizing user experience. We investigated how users of long-acting gels and intravaginal rings (IVRs) impute meaning to characteristics that may affect future product use. Focus groups were conducted with contraceptive IVR and vaginal lubricant users. Current perceptibility science and historical theory on the cultural acceptability of fertility regulating methods informed the analysis. A total of 21 IVR users and 29 lubricant users attended focus groups in which they manipulated products in their hands and discussed reactions to product characteristics. Participants used prior product experiences and sensory perceptions of prototype manipulations to inform meanings about product properties and performance for pregnancy, disease prevention, comfort, and perceived efficacy. The meanings derived from product characteristics depended on why the product would be used; a characteristic deemed problematic in one risk context may be considered preferable in another. Intravaginal product users create narratives that ascribe influence or causality to product characteristics. These meanings, whether correct or incorrect biologically, will shape vaginal product acceptability, use, and effectiveness. Long-acting and sustained-release drug delivery systems will be part of the multipurpose prevention continuum. Developers must consider how sensory experiences and culturally salient assumptions shape the meanings users make of product design characteristics. Those meanings will ultimately impact use and effectiveness. Copyright © 2015 Elsevier Inc. All rights reserved.

  3. The acceptability of acupuncture for low back pain: a qualitative study of patient's experiences nested within a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Ann Hopton

    Full Text Available INTRODUCTION: The National Institute for Health and Clinical Excellence guidelines recommend acupuncture as a clinically effective treatment for chronic back pain. However, there is insufficient knowledge of what factors contribute to patients' positive and negative experiences of acupuncture, and how those factors interact in terms of the acceptability of treatment. This study used patient interviews following acupuncture treatment for back pain to identify, understand and describe the elements that contribute or detract from acceptability of treatment. METHODS: The study used semi-structured interviews. Twelve patients were interviewed using an interview schedule as a sub-study nested within a randomised controlled trial of acupuncture for chronic back pain. The interviews were analysed using thematic analysis. RESULTS AND DISCUSSION: Three over-arching themes emerged from the analysis. The first entitled facilitators of acceptability contained five subthemes; experience of pain relief, improvements in physical activity, relaxation, psychological benefit, reduced reliance on medication. The second over-arching theme identified barriers to acceptability, which included needle-related discomfort and temporary worsening of symptoms, pressure to continue treatment and financial cost. The third over-arching theme comprised mediators of acceptability, which included pre-treatment mediators such as expectation and previous experience, and treatment-related mediators of time, therapeutic alliance, lifestyle advice and the patient's active involvement in recovery. These themes inform our understanding of the acceptability of acupuncture to patients with low back pain. CONCLUSION: The acceptability of acupuncture treatment for low back pain is complex and multifaceted. The therapeutic relationship between the practitioner and patient emerged as a strong driver for acceptability, and as a useful vehicle to develop the patients' self-efficacy in pain

  4. Effects of mindfulness on maternal stress, depressive symptoms and awareness of present moment experience: A pilot randomised trial.

    Science.gov (United States)

    Beattie, Jill; Hall, Helen; Biro, Mary Anne; East, Christine; Lau, Rosalind

    2017-07-01

    To determine the feasibility and acceptability and measure the effects of a mindfulness intervention compared to a pregnancy support program on stress, depressive symptoms and awareness of present moment experience. A pilot randomised trial using mixed methods. Forty-eight women attending a maternity service were randomly allocated to a mindfulness-based or pregnancy support program. Perceived Stress Scale, Edinburgh Postnatal Depression Scale, Mindfulness Attention Awareness Scale, and Birth Outcomes. Women's perceptions of the impact of the programs were examined via summative evaluation, interviews, diaries and facilitator field notes. Nine women in the mindfulness program and 11 in the pregnancy support program completed post-program measures. There were no statistically significant differences between groups. Of practical significance, was an improvement in measures for both groups with a greater improvement in awareness of present moment experience for the intervention group. The intervention group reported learning how to manage stressors, fear, anxiety, and to regulate their attention to be more present. The control group reported learning how to calm down when stressed which increased their confidence. Intervention group themes were: releasing stress, becoming aware, accepting, having options and choices, connecting and being compassionate. Control group themes were:managing stress, increasing confidence, connecting, focussing, being accepted, preparing. The feasibility and acceptability of the intervention was confirmed. Programs decreased women's self-reported stress in different ways. Women in the mindfulness program accepted themselves and their experiences as they arose and passed in the present moment, while those in the control group gained acceptance primarily from external sources such as peers. Mindfulness programs can foster an internalised locus of self-acceptance which may result in woman becoming less dependent on others for their wellbeing

  5. Everolimus and long acting octreotide as a volume reducing treatment of polycystic livers (ELATE: study protocol for a randomized controlled trial

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    Chrispijn Melissa

    2011-11-01

    Full Text Available Abstract Background Polycystic liver disease (PLD is defined as having more than 20 liver cysts and can present as a severe and disabling condition. Most symptoms are caused by the mass effect of the liver size and include abdominal pain and distension. The somatostatin analogues octreotide and lanreotide have proven to reduce polycystic liver volume. mTOR inhibitors such as everolimus inhibit cell proliferation and might thereby reduce growth of liver cysts. This trial aims to assess the benefit of combination therapy of everolimus and octreotide compared to octreotide monotherapy. In this study we present the structure of the trial and the characteristics of the included patients. Methods/design This is a randomized open-label clinical trial comparing the effect of 12 months of everolimus and octreotide to octreotide monotherapy in PLD patients. Primary outcome is change in liver volume determined by CT-volumetry. Secondary outcomes are changes in abdominal symptoms and quality of life. Moreover, safety and tolerability of the drugs will be assessed. Discussion This trial will compare the relative efficacy of combination therapy with octreotide and everolimus to octreotide monotherapy. Since they apply to different pathways of cystogenesis we expect that combining octreotide and everolimus will result in a cumulative reduction of polycystic liver volume. Trial registration number ClinicalTrials.gov: NCT01157858

  6. Participant experiences from chronic administration of a multivitamin versus placebo on subjective health and wellbeing: a double-blind qualitative analysis of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sarris Jerome

    2012-12-01

    Full Text Available Abstract Background While many randomised controlled trials have been conducted on multivitamins, to our knowledge no qualitative research exploring the subjective experience of taking a multivitamin during a clinical trial has been reported. Methods Semi-structured and open-ended written questions were incorporated into a 16-week double-blind, randomised, placebo-controlled, parallel groups trial of once-daily multivitamin administration. At the final study visit (week 16, three open-ended questions were posed to elucidate any positive, negative or unusual experiences from taking either the multivitamin or matched placebo. Qualitative thematic analysis was undertaken by researchers who were blind as to treatment condition of participants, and triangulation (independent analysis from three researchers was employed to ensure methodological rigour. Participant’s experiences were categorised as “positive” or “negative” and a Chi Square analysis was then applied to each of the experiential themes, to compare experiences between the multivitamin and placebo groups, (subdividing the groups by gender. Usual experiences were categorised and discussed separately. Results Of the 182 participants enrolled, 116 completed the study and qualitative data were available from 114 participants. Thematic analysis revealed significant effects in favour of the multivitamin over placebo for participants experiencing increased energy levels (p=.022 and enhanced mood (p=.027. The beneficial effect on energy levels was particularly evident among female participants. A trend was found for participants reporting better sleep in the multivitamin over placebo. The multivitamin and placebo groups did not significantly differ in perceived positive or negative effects in areas relating to other aspects of mental function or physical health. No significant negative effects were revealed, although there was a non-significant trend for more people in the multivitamin

  7. A therapeutic application of the experience sampling method in the treatment of depression: a randomized controlled trial

    Science.gov (United States)

    Kramer, Ingrid; Simons, Claudia JP; Hartmann, Jessica A; Menne-Lothmann, Claudia; Viechtbauer, Wolfgang; Peeters, Frenk; Schruers, Koen; Bemmel, Alex L; Myin-Germeys, Inez; Delespaul, Philippe; Os, Jim; Wichers, Marieke

    2014-01-01

    In depression, the ability to experience daily life positive affect predicts recovery and reduces relapse rates. Interventions based on the experience sampling method (ESM-I) are ideally suited to provide insight in personal, contextualized patterns of positive affect. The aim of this study was to examine whether add-on ESM-derived feedback on personalized patterns of positive affect is feasible and useful to patients, and results in a reduction of depressive symptomatology. Depressed outpatients (n=102) receiving pharmacological treatment participated in a randomized controlled trial with three arms: an experimental group receiving add-on ESM-derived feedback, a pseudo-experimental group participating in ESM but receiving no feedback, and a control group. The experimental group participated in an ESM procedure (three days per week over a 6-week period) using a palmtop. This group received weekly standardized feedback on personalized patterns of positive affect. Hamilton Depression Rating Scale – 17 (HDRS) and Inventory of Depressive Symptoms (IDS) scores were obtained before and after the intervention. During a 6-month follow-up period, five HDRS and IDS assessments were completed. Add-on ESM-derived feedback resulted in a significant and clinically relevant stronger decrease in HDRS score relative to the control group (p<0.01; −5.5 point reduction in HDRS at 6 months). Compared to the pseudo-experimental group, a clinically relevant decrease in HDRS score was apparent at 6 months (B=−3.6, p=0.053). Self-reported depressive complaints (IDS) yielded the same pattern over time. The use of ESM-I was deemed acceptable and the provided feedback easy to understand. Patients attempted to apply suggestions from ESM-derived feedback to daily life. These data suggest that the efficacy of traditional passive pharmacological approach to treatment of major depression can be enhanced by using person-tailored daily life information regarding positive affect. PMID:24497255

  8. How experiences become data: the process of eliciting adverse event, medical history and concomitant medication reports in antimalarial and antiretroviral interaction trials.

    Science.gov (United States)

    Allen, Elizabeth N; Mushi, Adiel K; Massawe, Isolide S; Vestergaard, Lasse S; Lemnge, Martha; Staedke, Sarah G; Mehta, Ushma; Barnes, Karen I; Chandler, Clare I R

    2013-11-14

    Accurately characterizing a drug's safety profile is essential. Trial harm and tolerability assessments rely, in part, on participants' reports of medical histories, adverse events (AEs), and concomitant medications. Optimal methods for questioning participants are unclear, but different methods giving different results can undermine meta-analyses. This study compared methods for eliciting such data and explored reasons for dissimilar participant responses. Participants from open-label antimalarial and antiretroviral interaction trials in two distinct sites (South Africa, n = 18 [all HIV positive]; Tanzania, n = 80 [86% HIV positive]) were asked about ill health and treatment use by sequential use of (1) general enquiries without reference to particular conditions, body systems or treatments, (2) checklists of potential health issues and treatments, (3) in-depth interviews. Participants' experiences of illness and treatment and their reporting behaviour were explored qualitatively, as were trial clinicians' experiences with obtaining participant reports. Outcomes were the number and nature of data by questioning method, themes from qualitative analyses and a theoretical interpretation of participants' experiences. There was an overall cumulative increase in the number of reports from general enquiry through checklists to in-depth interview; in South Africa, an additional 12 medical histories, 21 AEs and 27 medications; in Tanzania an additional 260 medical histories, 1 AE and 11 medications. Checklists and interviews facilitated recognition of health issues and treatments, and consideration of what to report. Information was sometimes not reported because participants forgot, it was considered irrelevant or insignificant, or they feared reporting. Some medicine names were not known and answers to questions were considered inferior to blood tests for detecting ill health. South African inpatient volunteers exhibited a "trial citizenship", working to achieve

  9. Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study.

    Science.gov (United States)

    Parker, Melissa J; de Laat, Sonya; Schwartz, Lisa

    2016-09-13

    Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Children's Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. Qualitative research study involving individual interviews and grounded theory methodology. SDMs for children enrolled into the SQUEEZE pilot trial. Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent. Findings will inform implementation of the exception to consent process in the planned definitive SQUEEZE

  10. Advancing engagement methods for trials: the CORE study relational model of engagement for a stepped wedge cluster randomised controlled trial of experience-based co-design for people living with severe mental illnesses.

    Science.gov (United States)

    Richard, Lauralie; Piper, Donella; Weavell, Wayne; Callander, Rosemary; Iedema, Rick; Furler, John; Pierce, David; Godbee, Kali; Gunn, Jane; Palmer, Victoria J

    2017-04-08

    Engagement is essential in trials research but is rarely embedded across all stages of the research continuum. The development, use, effectiveness and value of engagement in trials research is poorly researched and understood, and models of engagement are rarely informed by theory. This article describes an innovative methodological approach for the development and application of a relational model of engagement in a stepped wedge designed cluster randomised controlled trial (RCT), the CORE study. The purpose of the model is to embed engagement across the continuum of the trial which will test if an experience-based co-design intervention improves psychosocial recovery for people affected by severe mental illness. The model was developed in three stages and used a structured iterative approach. A context mapping assessment of trial sites was followed by a literature review on recruitment and retention of hard-to-reach groups in complex interventions and RCTs. Relevant theoretical and philosophical underpinnings were identified by an additional review of literature to inform model development and enactment of engagement activities. Policy, organisational and service user data combined with evidence from the literature on barriers to recruitment provided contextual information. Four perspectives support the theoretical framework of the relational model of engagement and this is organised around two facets: the relational and continuous. The relational facet is underpinned by relational ethical theories and participatory action research principles. The continuous facet is supported by systems thinking and translation theories. These combine to enact an ethics of engagement and evoke knowledge mobilisation to reach the higher order goals of the model. Engagement models are invaluable for trials research, but there are opportunities to advance their theoretical development and application, particularly within stepped wedge designed studies where there may be a

  11. 78 FR 1206 - Privacy Act of 1974; System of Records-Evaluation of the Pell Grant Experiments Under the...

    Science.gov (United States)

    2013-01-08

    ... interpreting the presence or lack of earnings impacts. 3. How does it affect financial aid receipt and student... examine the impacts of the experiments on the types and amounts of financial aid students receive and on... through the Internet, use the following address: comments@ed.gov . You must include the term ``Pell...

  12. Recruiting young people with a visible difference to the YP Face IT feasibility trial: a qualitative exploration of primary care staff experiences.

    Science.gov (United States)

    Hamlet, Claire; Williamson, Heidi; Harcourt, Diana

    2017-08-14

    Qualitative research methods embedded within feasibility trials are of significant value as they can provide important information for a definitive trial, often unable to be fulfilled by quantitative methods alone. In addition, such information can aid researchers running other trials or evaluating interventions on a similar topic. Aim This study aimed to explore GP and nurses' experiences of recruiting to a trial exploring the feasibility of evaluating YP Face IT, a novel online psychosocial intervention to support young people with appearance-altering conditions. During the recruitment period, a focus group with participating GPs and nurses explored recruitment challenges. In addition, at the end of the recruitment period, telephone interviews were conducted with eight GPs and nurses involved in recruiting to the study, in order to inform a definitive trial of YP Face IT. Transcripts were subjected to thematic analysis. Findings Despite reporting that the study was valuable and interesting, interviewees struggled to recruit in-consultation. They appeared to lack confidence in raising the sensitive issue of a visible difference and adopted strategies to avoid mentioning the topic. Participants felt the nature of the target population, as well as pressures of the primary care environment presented challenges to recruitment, but welcomed YP Face IT as an intervention that could address unmet support needs. Primary care staff may benefit from training to help them raise the subject of a visible difference with young people in order to identify those that require additional support.

  13. Current Experience in Testing Mitochondrial Nutrients in Disorders Featuring Oxidative Stress and Mitochondrial Dysfunction: Rational Design of Chemoprevention Trials

    Directory of Open Access Journals (Sweden)

    Giovanni Pagano

    2014-11-01

    Full Text Available An extensive number of pathologies are associated with mitochondrial dysfunction (MDF and oxidative stress (OS. Thus, mitochondrial cofactors termed “mitochondrial nutrients” (MN, such as α-lipoic acid (ALA, Coenzyme Q10 (CoQ10, and l-carnitine (CARN (or its derivatives have been tested in a number of clinical trials, and this review is focused on the use of MN-based clinical trials. The papers reporting on MN-based clinical trials were retrieved in MedLine up to July 2014, and evaluated for the following endpoints: (a treated diseases; (b dosages, number of enrolled patients and duration of treatment; (c trial success for each MN or MN combinations as reported by authors. The reports satisfying the above endpoints included total numbers of trials and frequencies of randomized, controlled studies, i.e., 81 trials testing ALA, 107 reports testing CoQ10, and 74 reports testing CARN, while only 7 reports were retrieved testing double MN associations, while no report was found testing a triple MN combination. A total of 28 reports tested MN associations with “classical” antioxidants, such as antioxidant nutrients or drugs. Combinations of MN showed better outcomes than individual MN, suggesting forthcoming clinical studies. The criteria in study design and monitoring MN-based clinical trials are discussed.

  14. Current Experience in Testing Mitochondrial Nutrients in Disorders Featuring Oxidative Stress and Mitochondrial Dysfunction: Rational Design of Chemoprevention Trials

    Science.gov (United States)

    Pagano, Giovanni; Aiello Talamanca, Annarita; Castello, Giuseppe; Cordero, Mario D.; d’Ischia, Marco; Gadaleta, Maria Nicola; Pallardó, Federico V.; Petrović, Sandra; Tiano, Luca; Zatterale, Adriana

    2014-01-01

    An extensive number of pathologies are associated with mitochondrial dysfunction (MDF) and oxidative stress (OS). Thus, mitochondrial cofactors termed “mitochondrial nutrients” (MN), such as α-lipoic acid (ALA), Coenzyme Q10 (CoQ10), and l-carnitine (CARN) (or its derivatives) have been tested in a number of clinical trials, and this review is focused on the use of MN-based clinical trials. The papers reporting on MN-based clinical trials were retrieved in MedLine up to July 2014, and evaluated for the following endpoints: (a) treated diseases; (b) dosages, number of enrolled patients and duration of treatment; (c) trial success for each MN or MN combinations as reported by authors. The reports satisfying the above endpoints included total numbers of trials and frequencies of randomized, controlled studies, i.e., 81 trials testing ALA, 107 reports testing CoQ10, and 74 reports testing CARN, while only 7 reports were retrieved testing double MN associations, while no report was found testing a triple MN combination. A total of 28 reports tested MN associations with “classical” antioxidants, such as antioxidant nutrients or drugs. Combinations of MN showed better outcomes than individual MN, suggesting forthcoming clinical studies. The criteria in study design and monitoring MN-based clinical trials are discussed. PMID:25380523

  15. Guided Act and Feel Indonesia (GAF-ID) - Internet-based behavioral activation intervention for depression in Indonesia : Study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Arjadi, R.; Nauta, M. H.; Scholte, W. F.; Hollon, S. D.; Chowdhary, N.; Suryani, A. O.; Bockting, C. L. H.

    2016-01-01

    Background: Depression is a leading cause of disease burden across the world. However, in low-middle income countries (LMICs), access to mental health services is severely limited because of the insufficient number of mental health professionals available. The WHO initiated the Mental Health Gap Act

  16. Guided Act and Feel Indonesia (GAF-ID) - Internet-based behavioral activation intervention for depression in Indonesia : study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Arjadi, Retha; Nauta, Maaike H; Scholte, Willem F; Hollon, Steven D; Chowdhary, Neerja; Suryani, Angela O; Bockting, Claudi L H

    2016-01-01

    BACKGROUND: Depression is a leading cause of disease burden across the world. However, in low-middle income countries (LMICs), access to mental health services is severely limited because of the insufficient number of mental health professionals available. The WHO initiated the Mental Health Gap Act

  17. Privacy Act

    Science.gov (United States)

    Learn about the Privacy Act of 1974, the Electronic Government Act of 2002, the Federal Information Security Management Act, and other information about the Environmental Protection Agency maintains its records.

  18. An adaptive, dose-finding, seamless phase 2/3 study of a long-acting glucagon-like peptide-1 analog (dulaglutide): trial design and baseline characteristics.

    Science.gov (United States)

    Geiger, Mary Jane; Skrivanek, Zachary; Gaydos, Brenda; Chien, Jenny; Berry, Scott; Berry, Donald

    2012-11-01

    Dulaglutide (dula, LY2189265) is a once-weekly glucagon-like peptide-1 analog in development for the treatment of type 2 diabetes mellitus. An adaptive, dose-finding, inferentially seamless phase 2/3 study was designed to support the development of this novel diabetes therapeutic. The study is divided into two stages based on two randomization schemes: a Bayesian adaptive scheme (stage 1) and a fixed scheme (stage 2). Stage 1 of the trial employs an adaptive, dose-finding design to lead to a dula dose-selection decision or early study termination due to futility. If dose selection occurs, the study proceeds to stage 2 to allow continued evaluation of the selected dula doses. At completion, the entire study will serve as a confirmatory phase 3 trial. The final study design is discussed, along with specifics pertaining to the actual execution of this study and selected baseline characteristics of the participants.

  19. Comparing the clinical-effectiveness and cost-effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Hayes, Sara; Hogan, Michael; Dowd, Haulie; Doherty, Edel; O'Higgins, Siobhan; Nic Gabhainn, Saoirse; MacNeela, Padraig; Murphy, Andrew W; Kropmans, Thomas; O'Neill, Ciaran; Newell, John; McGuire, Brian E

    2014-07-02

    Internet-delivered psychological interventions among people with chronic pain have the potential to overcome environmental and economic barriers to the provision of evidence-based psychological treatment in the Irish health service context. While the use of internet-delivered cognitive-behavioural therapy programmes has been consistently shown to have small-to-moderate effects in the management of chronic pain, there is a paucity in the research regarding the effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) programme among people with chronic pain. The current study will compare the clinical-effectiveness and cost-effectiveness of an online ACT intervention with a waitlist control condition in terms of the management of pain-related functional interference among people with chronic pain. Participants with non-malignant pain that persists for at least 3 months will be randomised to one of two study conditions. The experimental group will undergo an eight-session internet-delivered ACT programme over an 8-week period. The control group will be a waiting list group and will be offered the ACT intervention after the 3-month follow-up period. Participants will be assessed preintervention, postintervention and at a 3-month follow-up. The primary outcome will be pain-related functional interference. Secondary outcomes will include: pain intensity, depression, global impression of change, acceptance of chronic pain and quality of life. A qualitative evaluation of the perspectives of the participants regarding the ACT intervention will be completed after the trial. The study will be performed in agreement with the Declaration of Helsinki and is approved by the National University of Ireland Galway Research Ethics Committee (12/05/05). The results of the trial will be published according to the CONSORT statement and will be presented at conferences and reported in peer-reviewed journals. ISRCTN18166896. Published by the BMJ Publishing Group

  20. Challenges in conducting multicenter, multicultural, and multilingual trials: a view from the literature and real-life experience reports.

    Science.gov (United States)

    Hanson, Beate; De Faoite, Diarmuid

    2013-01-01

    A trend toward international multicenter clinical trials in the medical device industry is helping to increase recruitment figures and to improve the generalizability of results, among other factors. However, working globally creates its own unique set of problems, which are rarely discussed in the literature. This article considers these issues from multicenter, multicultural, and multilingual perspectives. A multicenter study implies a replication of work to coordinate research sites that are working under different regulations. Standardizing elements of the clinical trial is essential for proper comparison of results. Multicultural differences manifest themselves in different forms in international clinical research. However, the impact of culture on a study's success is a real issue, particularly when patient-reported outcomes form part of the trial. A trial that is conducted globally obviously requires the use of local language material, but this element is fraught with the possibility of mistranslation and misunderstanding. In this article, we also examine the composition of a research team and how to keep everyone involved in a global clinical trial both informed and enthused about a trial that may last several years. Examples from our own clinical investigations are reported throughout this article.

  1. Effect of dignity therapy on distress and end-of-life experience in terminally ill patients: a randomised controlled trial.

    Science.gov (United States)

    Chochinov, Harvey Max; Kristjanson, Linda J; Breitbart, William; McClement, Susan; Hack, Thomas F; Hassard, Tom; Harlos, Mike

    2011-08-01

    Dignity therapy is a unique, individualised, short-term psychotherapy that was developed for patients (and their families) living with life-threatening or life-limiting illness. We investigated whether dignity therapy could mitigate distress or bolster the experience in patients nearing the end of their lives. Patients (aged ≥18 years) with a terminal prognosis (life expectancy ≤6 months) who were receiving palliative care in a hospital or community setting (hospice or home) in Canada, USA, and Australia were randomly assigned to dignity therapy, client-centred care, or standard palliative care in a 1:1:1 ratio. Randomisation was by use of a computer-generated table of random numbers in blocks of 30. Allocation concealment was by use of opaque sealed envelopes. The primary outcomes--reductions in various dimensions of distress before and after completion of the study--were measured with the Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale, Patient Dignity Inventory, Hospital Anxiety and Depression Scale, items from the Structured Interview for Symptoms and Concerns, Quality of Life Scale, and modified Edmonton Symptom Assessment Scale. Secondary outcomes of self-reported end-of-life experiences were assessed in a survey that was undertaken after the completion of the study. Outcomes were assessed by research staff with whom the participant had no previous contact to avoid any possible response bias or contamination. Analyses were done on all patients with available data at baseline and at the end of the study intervention. This study is registered with ClinicalTrials.gov, number NCT00133965. 165 of 441 patients were assigned to dignity therapy, 140 standard palliative care, and 136 client-centred care. 108, 111, and 107 patients, respectively, were analysed. No significant differences were noted in the distress levels before and after completion of the study in the three groups. For the secondary outcomes, patients reported that

  2. Act local, think global: how the Malawi experience of scaling up antiretroviral treatment has informed global policy.

    Science.gov (United States)

    Harries, Anthony D; Ford, Nathan; Jahn, Andreas; Schouten, Erik J; Libamba, Edwin; Chimbwandira, Frank; Maher, Dermot

    2016-01-01

    The scale-up of antiretroviral therapy (ART) in Malawi was based on a public health approach adapted to its resource-poor setting, with principles and practices borrowed from the successful tuberculosis control framework. From 2004 to 2015, the number of new patients started on ART increased from about 3000 to over 820,000. Despite being a small country, Malawi has made a significant contribution to the 15 million people globally on ART and has also contributed policy and service delivery innovations that have supported international guidelines and scale up in other countries. The first set of global guidelines for scaling up ART released by the World Health Organization (WHO) in 2002 focused on providing clinical guidance. In Malawi, the ART guidelines adopted from the outset a more operational and programmatic approach with recommendations on health systems and services that were needed to deliver HIV treatment to affected populations. Seven years after the start of national scale-up, Malawi launched a new strategy offering all HIV-infected pregnant women lifelong ART regardless of the CD4-cell count, named Option B+. This strategy was subsequently incorporated into a WHO programmatic guide in 2012 and WHO ART guidelines in 2013, and has since then been adopted by the majority of countries worldwide. In conclusion, the Malawi experience of ART scale-up has become a blueprint for a public health response to HIV and has informed international efforts to end the AIDS epidemic by 2030.

  3. The first clinical experience on efficacy of topical flutamide on melasma compared with topical hydroquinone: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Adalatkhah H

    2015-08-01

    Full Text Available Hassan Adalatkhah,1 Homayoun Sadeghi-Bazargani2,3 1Department of Dermatology, Ardabil University of Medical Sciences, Ardabil, Iran; 2Road Traffic Injury Research Center, Department of Statistics and Epidemiology, Tabriz University of Medical Sciences, Tabriz, Iran; 3Department of Public Health Sciences, Karolinska Institute, Stockholm, Sweden Background: Treatment of melasma is unsatisfactory most of the times. Hormonal role is shown to exist in pathogenesis of the melasma, and sex-hormone related drugs may have an effect on melasma.Aim: To investigate efficacy of 1% flutamide cream versus 4% hydroquinone cream on melasma.Methods: In a parallel randomized clinical trial, 74 women with melasma were allocated to receive a sunscreen along with 4% hydroquinone cream or 1% flutamide cream. Melasma Area and Severity Index (MASI, mexameter melanin assay, and patient satisfaction were investigated.Results: Mean age of the participants was 33.8 years. Mean length of time suffering from Melasma was 96.3 months. The subjects reported in average 1.1 hours per day of exposure to sunlight. Mean standardized total patient satisfaction score was 28.8 (standard deviation [SD] 17.2 in flutamide group patients versus 18 (SD 15.5 in control group (P<0.01. Regardless of treatment group, the skin darkness assessed upon MASI scales was reduced over the treatment course (P<0.001. Using mixed effects, longitudinal modeling showed better treatment efficacy based on MASI scale for flutamide group compared to the hydroquinone group (P<0.05. However, longitudinal analysis of mexameter scores did not reveal any significant difference in melanin measurements between flutamide and hydroquinone.Conclusion: Topical flutamide appeared as effective as topical hydroquinone in treating melasma using mexameter assessment but with a better MASI improvement trend and higher patient satisfaction in flutamide treatment versus topical hydroquinone. As the present study is possibly the

  4. Reasons Why Individuals Remain Uninsured Under the Affordable Care Act: Experiences of Patients at a Student-Run Free Clinic in Michigan, a Medicaid Expansion State.

    Science.gov (United States)

    Desmond, Brian S; Laux, Molly A; Levin, Carolyn C; Huang, Jiaxin; Williams, Brent C

    2016-04-01

    Since the enactment of the Affordable Care Act (ACA), many people remain uninsured. While studies have examined this population, few have explored patients' experiences seeking insurance. To elucidate these individuals' perspectives, we surveyed patients (n = 80) at the University of Michigan Student-Run Free Clinic concerning their activity accessing insurance. Over half of respondents had sought insurance in the past 6 months; 57 % of respondents qualified for Medicaid by self-reported income (≤138 % FPL) and all but one were eligible for tax credits on the Health Insurance Marketplace. However, only 35 % of apparently Medicaid-eligible respondents had recently applied. There was no significant difference in the rate of applying for those above the income cutoff (p = 0.901). Perceived expense of plans and belief of ineligibility for Medicaid discouraged respondents from actively seeking insurance. Personalized outreach emphasizing new Medicaid eligibility requirements and tax credits may be needed to facilitate Medicaid enrollment for some uninsured persons under the ACA.

  5. A combined early cognitive and physical rehabilitation program for people who are critically ill: the activity and cognitive therapy in the intensive care unit (ACT-ICU) trial.

    Science.gov (United States)

    Brummel, Nathan E; Jackson, James C; Girard, Timothy D; Pandharipande, Pratik P; Schiro, Elena; Work, Brittany; Pun, Brenda T; Boehm, Leanne; Gill, Thomas M; Ely, E Wesley

    2012-12-01

    In the coming years, the number of survivors of critical illness is expected to increase. These survivors frequently develop newly acquired physical and cognitive impairments. Long-term cognitive impairment is common following critical illness and has dramatic effects on patients' abilities to function autonomously. Neuromuscular weakness affects similar proportions of patients and leads to equally profound life alterations. As knowledge of these short-term and long-term consequences of critical illness has come to light, interventions to prevent and rehabilitate these devastating consequences have been sought. Physical rehabilitation has been shown to improve functional outcomes in people who are critically ill, but subsequent studies of physical rehabilitation after hospital discharge have not. Post-hospital discharge cognitive rehabilitation is feasible in survivors of critical illness and is commonly used in people with other forms of acquired brain injury. The feasibility of early cognitive therapy in people who are critically ill remains unknown. The purpose of this novel protocol trial will be to determine the feasibility of early and sustained cognitive rehabilitation paired with physical rehabilitation in patients who are critically ill from medical and surgical intensive care units. This is a randomized controlled trial. The setting for this trial will be medical and surgical intensive care units of a large tertiary care referral center. The participants will be patients who are critically ill with respiratory failure or shock. Patients will be randomized to groups receiving usual care, physical rehabilitation, or cognitive rehabilitation plus physical rehabilitation. Twice-daily cognitive rehabilitation sessions will be performed with patients who are noncomatose and will consist of orientation, memory, and attention exercises (eg, forward and reverse digit spans, matrix puzzles, letter-number sequences, pattern recognition). Daily physical

  6. A Combined Early Cognitive and Physical Rehabilitation Program for People Who Are Critically Ill: The Activity and Cognitive Therapy in the Intensive Care Unit (ACT-ICU) Trial

    Science.gov (United States)

    Jackson, James C.; Girard, Timothy D.; Pandharipande, Pratik P.; Schiro, Elena; Work, Brittany; Pun, Brenda T.; Boehm, Leanne; Gill, Thomas M.; Ely, E. Wesley

    2012-01-01

    Background In the coming years, the number of survivors of critical illness is expected to increase. These survivors frequently develop newly acquired physical and cognitive impairments. Long-term cognitive impairment is common following critical illness and has dramatic effects on patients' abilities to function autonomously. Neuromuscular weakness affects similar proportions of patients and leads to equally profound life alterations. As knowledge of these short-term and long-term consequences of critical illness has come to light, interventions to prevent and rehabilitate these devastating consequences have been sought. Physical rehabilitation has been shown to improve functional outcomes in people who are critically ill, but subsequent studies of physical rehabilitation after hospital discharge have not. Post-hospital discharge cognitive rehabilitation is feasible in survivors of critical illness and is commonly used in people with other forms of acquired brain injury. The feasibility of early cognitive therapy in people who are critically ill remains unknown. Objective The purpose of this novel protocol trial will be to determine the feasibility of early and sustained cognitive rehabilitation paired with physical rehabilitation in patients who are critically ill from medical and surgical intensive care units. Design This is a randomized controlled trial. Setting The setting for this trial will be medical and surgical intensive care units of a large tertiary care referral center. Patients The participants will be patients who are critically ill with respiratory failure or shock. Intervention Patients will be randomized to groups receiving usual care, physical rehabilitation, or cognitive rehabilitation plus physical rehabilitation. Twice-daily cognitive rehabilitation sessions will be performed with patients who are noncomatose and will consist of orientation, memory, and attention exercises (eg, forward and reverse digit spans, matrix puzzles, letter

  7. The effectiveness of physical activity monitoring and distance counseling in an occupational setting – Results from a randomized controlled trial (CoAct

    Directory of Open Access Journals (Sweden)

    Reijonsaari Karita

    2012-05-01

    Full Text Available Abstract Background Lack of physical activity (PA is a known risk factor for many health conditions. The workplace is a setting often used to promote activity and health. We investigated the effectiveness of an intervention on PA and productivity-related outcomes in an occupational setting. Methods We conducted a randomized controlled trial of 12 months duration with two 1:1 allocated parallel groups of insurance company employees. Eligibility criteria included permanent employment and absence of any condition that risked the participant’s health during PA. Subjects in the intervention group monitored their daily PA with an accelerometer, set goals, had access to an online service to help them track their activity levels, and received counseling via telephone or web messages for 12 months. The control group received the results of a fitness test and an information leaflet on PA at the beginning of the study. The intervention’s aim was to increase PA, improve work productivity, and decrease sickness absence. Primary outcomes were PA (measured as MET minutes per week, work productivity (quantity and quality of work; QQ index, and sickness absence (SA days at 12 months. Participants were assigned to groups using block randomization with a computer-generated scheme. The study was not blinded. Results There were 544 randomized participants, of which 521 were included in the analysis (64% female, mean age 43 years. At 12 months, there was no significant difference in physical activity levels between the intervention group (n = 264 and the control group (n = 257. The adjusted mean difference was −206 MET min/week [95% Bayesian credible interval −540 to 128; negative values favor control group]. There was also no significant difference in the QQ index (−0.5 [−4.4 to 3.3] or SA days (0.0 [−1.2 to 0.9]. Of secondary outcomes, body weight (0.5 kg [0.0 to 1.0] and percentage of body fat (0.6% [0.2% to 1.1%] were slightly

  8. iACT-CEL: A Feasibility Trial of a Face-to-Face and Internet-Based Acceptance and Commitment Therapy Intervention for Chronic Pain in Singapore.

    Science.gov (United States)

    Yang, Su-Yin; Moss-Morris, Rona; McCracken, Lance M

    2017-01-01

    Psychological interventions are increasingly utilising online or mobile phone based platforms to deliver treatment, including that for people with chronic pain. The aims of this study were to develop an adapted form of Acceptance and Commitment Therapy (ACT) for chronic pain in Singapore and to test the feasibility of elements of this treatment delivered via the internet and email. Methods. Thirty-three participants recruited from a tertiary pain management clinic and via the clinic website participated in this program over a period of five weeks with a 3-month follow-up. Treatment outcomes were assessed at three assessment time points. Results. 90.9% of participants completed the program, with 81.8% reporting high treatment satisfaction. Significant changes in depression, t = 3.08, p = 0.002 (baseline to posttreatment), t = 3.28, p = 0.001 (baseline to follow-up), and pain intensity, t = 2.15, p = 0.03 (baseline to follow-up) were found. Mainly small effect sizes (d = 0.09-0.39) with a moderate effect size (d = 0.51) for depression were found at posttreatment. Clinically meaningful improvement in at least one outcome was demonstrated in 75.8% of participants. Conclusions. An adaptation of ACT for people with chronic pain in Singapore appears promising. Optimal treatment design and more effective ways to target outcomes and processes measured here are required.

  9. iACT-CEL: A Feasibility Trial of a Face-to-Face and Internet-Based Acceptance and Commitment Therapy Intervention for Chronic Pain in Singapore

    Directory of Open Access Journals (Sweden)

    Su-Yin Yang

    2017-01-01

    Full Text Available Psychological interventions are increasingly utilising online or mobile phone based platforms to deliver treatment, including that for people with chronic pain. The aims of this study were to develop an adapted form of Acceptance and Commitment Therapy (ACT for chronic pain in Singapore and to test the feasibility of elements of this treatment delivered via the internet and email. Methods. Thirty-three participants recruited from a tertiary pain management clinic and via the clinic website participated in this program over a period of five weeks with a 3-month follow-up. Treatment outcomes were assessed at three assessment time points. Results. 90.9% of participants completed the program, with 81.8% reporting high treatment satisfaction. Significant changes in depression, t=3.08, p=0.002 (baseline to posttreatment, t=3.28, p=0.001 (baseline to follow-up, and pain intensity, t=2.15, p=0.03 (baseline to follow-up were found. Mainly small effect sizes (d=0.09–0.39 with a moderate effect size (d=0.51 for depression were found at posttreatment. Clinically meaningful improvement in at least one outcome was demonstrated in 75.8% of participants. Conclusions. An adaptation of ACT for people with chronic pain in Singapore appears promising. Optimal treatment design and more effective ways to target outcomes and processes measured here are required.

  10. After the Gold Rush: Questioning the "Gold Standard" and Reappraising the Status of Experiment and Randomized Controlled Trials in Education

    Science.gov (United States)

    Thomas, Gary

    2016-01-01

    The past few years have seen a resurgence of faith in experimentation in education inquiry, and particularly in randomized controlled trials (RCTs). Proponents of such research have succeeded in bringing into common parlance the term "gold standard," which suggests that research emerging from any other design frame fails to achieve the…

  11. Study protocol: an early intervention program to improve motor outcome in preterm infants: a randomized controlled trial and a qualitative study of physiotherapy performance and parental experiences

    Directory of Open Access Journals (Sweden)

    Øberg Gunn

    2012-02-01

    Full Text Available Abstract Background Knowledge about early physiotherapy to preterm infants is sparse, given the risk of delayed motor development and cerebral palsy. Methods/Design A pragmatic randomized controlled study has been designed to assess the effect of a preventative physiotherapy program carried out in the neonatal intensive care unit. Moreover, a qualitative study is carried out to assess the physiotherapy performance and parents' experiences with the intervention. The aim of the physiotherapy program is to improve motor development i.e. postural control and selective movements in these infants. 150 infants will be included and randomized to either intervention or standard follow-up. The infants in the intervention group will be given specific stimulation to facilitate movements based on the individual infant's development, behavior and needs. The physiotherapist teaches the parents how to do the intervention and the parents receive a booklet with photos and descriptions of the intervention. Intervention is carried out twice a day for three weeks (week 34, 35, 36 postmenstrual age. Standardized tests are carried out at baseline, term age and at three, six, 12 and 24 months corrected age. In addition eight triads (infant, parent and physiotherapist are observed and videotaped in four clinical encounters each to assess the process of physiotherapy performance. The parents are also interviewed on their experiences with the intervention and how it influences on the parent-child relationship. Eight parents from the follow up group are interviewed about their experience. The interviews are performed according to the same schedule as the standardized measurements. Primary outcome is at two years corrected age. Discussion The paper presents the protocol for a randomized controlled trial designed to study the effect of physiotherapy to preterm infants at neonatal intensive care units. It also studies physiotherapy performance and the parent's experiences

  12. 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

  13. Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Ma Yi-Wen

    2011-04-01

    Full Text Available Abstract Background This post hoc analysis (trial registration: ClinicalTrials.gov NCT00590577 assessed onset of efficacy and tolerability of acute treatment with once-monthly paliperidone palmitate (PP, a long-acting atypical antipsychotic initiated by day 1 and day 8 injections, in a markedly to severely ill schizophrenia population. Methods Subjects entering the 13-week, double-blind trial were randomized to PP (39, 156, or 234 mg [25, 100, and 150 mg eq of paliperidone, respectively] or placebo. This subgroup analysis included those with a baseline Clinical Global Impressions-Severity (CGI-S score indicating marked to severe illness. PP subjects received a 234-mg day 1 injection (deltoid, followed by their assigned dose on day 8 and monthly thereafter (deltoid or gluteal. Thus, data for PP groups were pooled for days 4 and 8. Measures included Positive and Negative Syndrome Scale (PANSS, CGI-S, Personal and Social Performance (PSP, and adverse events (AEs. Analysis of covariance (ANCOVA and last-observation-carried-forward (LOCF methodologies, without multiplicity adjustments, were used to assess changes in continuous measures. Onset of efficacy was defined as the first time point a treatment group showed significant PANSS improvement (assessed days 4, 8, 22, 36, 64, and 92 versus placebo, which was maintained through end point. Results A total of 312 subjects met inclusion criterion for this subgroup analysis. After the day 1 injection, mean PANSS total scores improved significantly with PP (all received 234 mg versus placebo at day 4 (P = 0.012 and day 8 (P = 0.007. After the day 8 injection, a significant PANSS improvement persisted at all subsequent time points in the 234-mg group versus placebo (P P P P Conclusions In this markedly to severely ill population, acute treatment with 234 mg PP improved psychotic symptoms compared with placebo by day 4. After subsequent injections, observed improvements are suggestive of a dose

  14. ACTS 2014

    DEFF Research Database (Denmark)

    Co-curator of ACTS 2014 together with Rasmus Holmboe, Judith Schwarzbart and Sanne Kofoed. ACTS is the Museum of Contemporary Art’s international bi-annual festival. ACTS was established in 2011 and, while the primary focus is on sound and performance art, it also looks toward socially oriented art...... various possibilities and public spaces as a stage. ACTS takes place in and around the museum and diverse locations in Roskilde city. ACTS is partly curated by the museum staff and partly by guest curators. ACTS 2014 is supported by Nordea-fonden and is a part of the project The Museum goes downtown....

  15. Young people at risk of psychosis: their subjective experiences of monitoring and cognitive behaviour therapy in the early detection and intervention evaluation 2 trial.

    Science.gov (United States)

    Byrne, Rory E; Morrison, Anthony P

    2014-09-01

    To explore participants' experiences of 'enhanced monitoring' and cognitive behaviour therapy (CBT) within a randomized controlled trial evaluating early detection and prevention of psychosis ('early detection and intervention evaluation [EDIE] 2'). Semi-structured qualitative interviews were conducted with a sample of participants at the end of their involvement with the trial. Ten young people were interviewed; six males and four females, with a mean age of 27.5. Nine participants identified themselves as White British and one Black British. All participants had received 'enhanced monitoring' during the trial, and 8 of 10 also received CBT. Interviews were transcribed verbatim and analysed using thematic analysis to identify central themes within and among participants' accounts. Three super-ordinate thematic areas were identified: 'a chance to talk', monitoring-specific themes, and CBT-specific themes. The central theme ('a chance to talk') was drawn from across all participants' accounts and represents the most consistently valued attribute of participants' experiences of the EDIE 2 trial. Sub-themes of this topic were identified as follows: interpersonal engagement, informality and normalization, and 'opening up'. Sub-themes related to monitoring include the following: clarity and reassurance, 'a therapeutic process', and challenges. CBT experience was most consistently conceptualized as 'rethinking things', and two additional CBT-specific sub-themes were identified: hard work and moving forward. Our findings suggest that for young people at risk of psychosis, a normalizing psychosocially oriented assessment and monitoring process may have benefits for many, while CBT may help to reduce the negative impact of unusual psychological experiences for both the short- and long term. Young people considered at risk of psychosis highly value normalizing, collaborative, and flexible approaches when engaging with research or clinical staff. All of our participants

  16. Ataluren in patients with nonsense mutation Duchenne muscular dystrophy (ACT DMD): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

    Science.gov (United States)

    McDonald, Craig M; Campbell, Craig; Torricelli, Ricardo Erazo; Finkel, Richard S; Flanigan, Kevin M; Goemans, Nathalie; Heydemann, Peter; Kaminska, Anna; Kirschner, Janbernd; Muntoni, Francesco; Osorio, Andrés Nascimento; Schara, Ulrike; Sejersen, Thomas; Shieh, Perry B; Sweeney, H Lee; Topaloglu, Haluk; Tulinius, Már; Vilchez, Juan J; Voit, Thomas; Wong, Brenda; Elfring, Gary; Kroger, Hans; Luo, Xiaohui; McIntosh, Joseph; Ong, Tuyen; Riebling, Peter; Souza, Marcio; Spiegel, Robert J; Peltz, Stuart W; Mercuri, Eugenio

    2017-07-17

    Duchenne muscular dystrophy (DMD) is a severe, progressive, and rare neuromuscular, X-linked recessive disease. Dystrophin deficiency is the underlying cause of disease; therefore, mutation-specific therapies aimed at restoring dystrophin protein production are being explored. We aimed to assess the efficacy and safety of ataluren in ambulatory boys with nonsense mutation DMD. We did this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial at 54 sites in 18 countries located in North America, Europe, the Asia-Pacific region, and Latin America. Boys aged 7-16 years with nonsense mutation DMD and a baseline 6-minute walk distance (6MWD) of 150 m or more and 80% or less of the predicted normal value for age and height were randomly assigned (1:1), via permuted block randomisation (block size of four) using an interactive voice-response or web-response system, to receive ataluren orally three times daily (40 mg/kg per day) or matching placebo. Randomisation was stratified by age (PTC Therapeutics employees, and all other study personnel were masked to group allocation until after database lock. The primary endpoint was change in 6MWD from baseline to week 48. We additionally did a prespecified subgroup analysis of the primary endpoint, based on baseline 6MWD, which is reflective of anticipated rates of disease progression over 1 year. The primary analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01826487. Between March 26, 2013, and Aug 26, 2014, we randomly assigned 230 patients to receive ataluren (n=115) or placebo (n=115); 228 patients comprised the intention-to-treat population. The least-squares mean change in 6MWD from baseline to week 48 was -47·7 m (SE 9·3) for ataluren-treated patients and -60·7 m (9·3) for placebo-treated patients (difference 13·0 m [SE 10·4], 95% CI -7·4 to 33·4; p=0·213). The least-squares mean change for ataluren versus placebo in the prespecified subgroups was -7

  17. Lessons learned while conducting a clinical trial to facilitate evidence-based practice: the neophyte researcher experience.

    Science.gov (United States)

    Brim, Carla B; Schoonover, Heather D

    2009-08-01

    Health care is incredibly complex. Now, more than ever, health care providers are being called on to deliver care that is based on evidence and is consistent with current professional knowledge. Educators often struggle to find time when staff are available to participate in scheduled education. The work of nursing staff is to provide patient care. This article describes the journey of neophyte researchers who conducted a clinical trial as a strategy to implement evidence-based practice. Although educational opportunities for the staff were included as part of the trial, there were also many challenges applicable to the neophyte researcher role. Those challenges included the participants' neophyte knowledge and perception of the research process, vendor relationships, data collection methods, staff perceptions, and the culture of the institution itself.

  18. Indispensable value of clinical trials in the modernization of traditional Chinese medicine: 12 years' experience at CUHK and future perspectives.

    Science.gov (United States)

    Liang, Willmann; Yew, David T; Hon, Kam Lun; Wong, Chun Kwok; Kwok, Timothy C Y; Leung, Ping Chung

    2014-01-01

    The last decade has seen a wealth of information reporting the beneficial effects of Chinese herbal medicines. While a lot more studies were done using in vitro and in vivo research platforms, much fewer investigations were conducted according to evidence-based requirements in clinical settings. The Institute of Chinese Medicine at the Chinese University of Hong Kong (CUHK) has had the opportunity to collaborate with clinicians over the years to initiate and conduct dozens of clinical trials investigating and verifying the therapeutic values of Chinese herbs in selected disease conditions. Of the many disorders, we chose to focus on those that are known for their difficulties achieving perfect results with conventional treatment methods. Examples include non-healing ulcers, allergic conditions, degenerative diseases and cancer. Protective effects of the herbs in such chronic diseases as coronary artery disease and osteoporosis were also part of our focus. Even in healthy individuals and those recovering from chemotherapy, Chinese herbs could help with the immune system and were studied in our clinical trials as well. This paper aims to highlight the important findings from these clinical studies while at the same time, stressing the indispensable value of clinical trials in modernizing the use of Chinese herbs in present-day medicine.

  19. Maintaining Treatment Fidelity of Mindfulness-Based Relapse Prevention Intervention for Alcohol Dependence: A Randomized Controlled Trial Experience

    Directory of Open Access Journals (Sweden)

    Aleksandra E. Zgierska

    2017-01-01

    Full Text Available Background. Treatment fidelity is essential to methodological rigor of clinical trials evaluating behavioral interventions such as Mindfulness Meditation (MM. However, procedures for monitoring and maintenance of treatment fidelity are inconsistently applied, limiting the strength of such research. Objective. To describe the implementation and findings related to fidelity monitoring of the Mindfulness-Based Relapse Prevention for Alcohol Dependence (MBRP-A intervention in a 26-week randomized controlled trial. Methods. 123 alcohol dependent adults were randomly assigned to MM (MBRP-A and home practice, adjunctive to usual care; N=64 or control (usual care alone; N=59. Treatment fidelity assessment strategies recommended by the National Institutes of Health Behavior Change Consortium for study/intervention design, therapist training, intervention delivery, and treatment receipt and enactment were applied. Results. Ten 8-session interventions were delivered. Therapist adherence and competence, assessed using the modified MBRP Adherence and Competence Scale, were high. Among the MM group participants, 46 attended ≥4 sessions; over 90% reported at-home MM practice at 8 weeks and 72% at 26 weeks. They also reported satisfaction with and usefulness of MM for maintaining sobriety. No adverse events were reported. Conclusions. A systematic approach to assessment of treatment fidelity in behavioral clinical trials allows determination of the degree of consistency between intended and actual delivery and receipt of intervention.

  20. Understanding barriers to involving community midwives in identifying research participants; experience of the first steps randomised controlled trial.

    Science.gov (United States)

    Stuart, Jane; Barnes, Jacqueline; Spiby, Helen; Elbourne, Diana

    2015-08-01

    to explore barriers to the involvement of community midwives in identifying women in early pregnancy as potential participants in the first steps study, a randomised controlled trial of a new intervention to provide health and parenting support to potentially vulnerable women. descriptive qualitative investigation using semi-structured audio-recorded interviews. community midwifery offices. volunteer sample of 13 community midwives. themes derived from content analysis. understanding of their role in the research process was unclear to many midwives. Confusion arose about the difference between potential participant identification and trial recruitment. There were concerns about the eligibility criteria and it was suggested that there was insufficient time during booking appointments, and sometimes insufficient information, to determine potential eligibility. Midwives had concerns about some aspects of the intervention, which incorporated routine midwifery care, and had expectations that women may not like a group programme. This may have led some not to mention the trial. They were, however positive about the programme׳s potential for beneficial impacts on mothers and infants. dedicated research midwives may be the best option if research studies need to identify potential participants early in pregnancy, so that they can communicate with all their colleagues. if community midwives are asked to be involved in time-critical research they are likely to need additional local resources and support. Copyright © 2015 Elsevier Ltd. All rights reserved.

  1. Balancing Opposing Forces—A Nested Process Evaluation Study Protocol for a Stepped Wedge Designed Cluster Randomized Controlled Trial of an Experience Based Codesign Intervention

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    Victoria Jane Palmer

    2016-10-01

    Full Text Available Background: Process evaluations are essential to understand the contextual, relational, and organizational and system factors of complex interventions. The guidance for developing process evaluations for randomized controlled trials (RCTs has until recently however, been fairly limited. Method/Design: A nested process evaluation (NPE was designed and embedded across all stages of a stepped wedge cluster RCT called the CORE study. The aim of the CORE study is to test the effectiveness of an experience-based codesign methodology for improving psychosocial recovery outcomes for people living with severe mental illness (service users. Process evaluation data collection combines qualitative and quantitative methods with four aims: (1 to describe organizational characteristics, service models, policy contexts, and government reforms and examine the interaction of these with the intervention; (2 to understand how the codesign intervention works, the cluster variability in implementation, and if the intervention is or is not sustained in different settings; (3 to assist in the interpretation of the primary and secondary outcomes and determine if the causal assumptions underpinning the codesign interventions are accurate; and (4 to determine the impact of a purposefully designed engagement model on the broader study retention and knowledge transfer in the trial. Discussion: Process evaluations require prespecified study protocols but finding a balance between their iterative nature and the structure offered by protocol development is an important step forward. Taking this step will advance the role of qualitative research within trials research and enable more focused data collection to occur at strategic points within studies.

  2. Pharmacoeconomic analysis of adjuvant oral capecitabine vs intravenous 5-FU/LV in Dukes' C colon cancer: the X-ACT trial

    Science.gov (United States)

    Cassidy, J; Douillard, J-Y; Twelves, C; McKendrick, J J; Scheithauer, W; Bustová, I; Johnston, P G; Lesniewski-Kmak, K; Jelic, S; Fountzilas, G; Coxon, F; Díaz-Rubio, E; Maughan, T S; Malzyner, A; Bertetto, O; Beham, A; Figer, A; Dufour, P; Patel, K K; Cowell, W; Garrison, L P

    2006-01-01

    Oral capecitabine (Xeloda®) is an effective drug with favourable safety in adjuvant and metastatic colorectal cancer. Oxaliplatin-based therapy is becoming standard for Dukes' C colon cancer in patients suitable for combination therapy, but is not yet approved by the UK National Institute for Health and Clinical Excellence (NICE) in the adjuvant setting. Adjuvant capecitabine is at least as effective as 5-fluorouracil/leucovorin (5-FU/LV), with significant superiority in relapse-free survival and a trend towards improved disease-free and overall survival. We assessed the cost-effectiveness of adjuvant capecitabine from payer (UK National Health Service (NHS)) and societal perspectives. We used clinical trial data and published sources to estimate incremental direct and societal costs and gains in quality-adjusted life months (QALMs). Acquisition costs were higher for capecitabine than 5-FU/LV, but higher 5-FU/LV administration costs resulted in 57% lower chemotherapy costs for capecitabine. Capecitabine vs 5-FU/LV-associated adverse events required fewer medications and hospitalisations (cost savings £3653). Societal costs, including patient travel/time costs, were reduced by >75% with capecitabine vs 5-FU/LV (cost savings £1318), with lifetime gain in QALMs of 9 months. Medical resource utilisation is significantly decreased with capecitabine vs 5-FU/LV, with cost savings to the NHS and society. Capecitabine is also projected to increase life expectancy vs 5-FU/LV. Cost savings and better outcomes make capecitabine a preferred adjuvant therapy for Dukes' C colon cancer. This pharmacoeconomic analysis strongly supports replacing 5-FU/LV with capecitabine in the adjuvant treatment of colon cancer in the UK. PMID:16622438

  3. Alvimopan, a peripherally acting μ-opioid receptor antagonist, is associated with reduced costs after radical cystectomy: economic analysis of a phase 4 randomized, controlled trial.

    Science.gov (United States)

    Kauf, Teresa L; Svatek, Robert S; Amiel, Gilad; Beard, Timothy L; Chang, Sam S; Fergany, Amr; Karnes, R Jeffrey; Koch, Michael; O'Hara, Jerome; Lee, Cheryl T; Sexton, Wade J; Slaton, Joel W; Steinberg, Gary D; Wilson, Shandra S; Techner, Lee; Martin, Carolyn; Moreno, Jessica; Kamat, Ashish M

    2014-06-01

    We evaluated the effect of alvimopan treatment vs placebo on health care utilization and costs related to gastrointestinal recovery in patients treated with radical cystectomy in a randomized, phase 4 clinical trial. Resource utilization data were prospectively collected and evaluated by cost consequence analysis. Hospital costs were estimated from 2012 Medicare reimbursement rates and medication wholesale acquisition costs. Differences in base case mean costs between the study cohorts for total postoperative ileus related costs (hospital days, study drug, nasogastric tubes, postoperative ileus related concomitant medication and postoperative ileus related readmissions) and total combined costs (postoperative ileus related, laboratory, electrocardiograms, nonpostoperative ileus related concomitant medication and nonpostoperative ileus related readmission) were evaluated by probabilistic sensitivity analysis using a bootstrap approach. Mean hospital stay was 2.63 days shorter for alvimopan than placebo (mean±SD 8.44±3.05 vs 11.07±8.23 days, p=0.005). Use of medications or interventions likely intended to diagnose or manage postoperative ileus was lower for alvimopan than for placebo, eg total parenteral nutrition 10% vs 25% (p=0.001). Postoperative ileus related health care costs were $2,340 lower for alvimopan and mean total combined costs were decreased by $2,640 per patient for alvimopan vs placebo. Analysis using a 10,000-iteration bootstrap approach showed that the mean difference in postoperative ileus related costs (p=0.04) but not total combined costs (p=0.068) was significantly lower for alvimopan than for placebo. In patients treated with radical cystectomy alvimopan decreased hospitalization cost by reducing the health care services associated with postoperative ileus and decreasing the hospital stay. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  4. Usability of a novel disposable autoinjector device for ixekizumab: results from a qualitative study and an open-label clinical trial, including patient-reported experience

    Science.gov (United States)

    Callis Duffin, Kristina; Bukhalo, Michael; Bobonich, Margaret A; Shrom, David; Zhao, Fangyi; Kershner, James R; Gill, Anne; Pangallo, Beth; Shuler, Catherine L; Bagel, Jerry

    2016-01-01

    Background Most biologic therapies for psoriasis are delivered via subcutaneous injection. Ixekizumab, an anti-interleukin 17A monoclonal antibody approved for patients with moderate-to-severe plaque psoriasis, is delivered subcutaneously via prefilled syringe or autoinjector. Here we report the results of an ixekizumab autoinjector usability study as well as the patient-reported experience with the autoinjector in a clinical trial. Methods The usability study enrolled 49 subjects (patients with a range of autoimmune conditions or their caregivers). Subjects were randomized to a trained or untrained group and were evaluated for their ability to perform an injection successfully when provided the device and the instructions for use. In the clinical trial, 102 subjects (patients with psoriasis or their caregivers) used the autoinjector to deliver injections of ixekizumab (80 mg every 2 weeks after a starting dose of 160 mg). At weeks 0, 4, and 8, subjects completed the subcutaneous administration assessment questionnaire, which assesses the ease of use and confidence with using an injection device. Results In the usability study, all subjects in the untrained arm performed successful injections, while two subjects in the trained arm had an injection failure. These incidences were not consistent with any pattern of issues with the device or the instructions for use. In the clinical trial, there were two injection failures of 674 total self-injections performed over 12 weeks. At the first use of the device, 95% of subjects either agreed or strongly agreed that the device was “overall easy to use”, and they felt “confident the dose was complete” according to the subcutaneous administration assessment questionnaire. Conclusion The ixekizumab autoinjector was used successfully by patients and caregivers with or without training. Subjects using the autoinjector in a clinical trial felt it was easy to use and felt confident while using it. PMID:27785115

  5. Scalable and Cost-Effective Assignment of Mobile Crowdsensing Tasks Based on Profiling Trends and Prediction: The ParticipAct Living Lab Experience

    Directory of Open Access Journals (Sweden)

    Paolo Bellavista

    2015-07-01

    Full Text Available Nowadays, sensor-rich smartphones potentially enable the harvesting of huge amounts of valuable sensing data in urban environments, by opportunistically involving citizens to play the role of mobile virtual sensors to cover Smart City areas of interest. This paper proposes an in-depth study of the challenging technical issues related to the efficient assignment of Mobile Crowd Sensing (MCS data collection tasks to volunteers in a crowdsensing campaign. In particular, the paper originally describes how to increase the effectiveness of the proposed sensing campaigns through the inclusion of several new facilities, including accurate participant selection algorithms able to profile and predict user mobility patterns, gaming techniques, and timely geo-notification. The reported results show the feasibility of exploiting profiling trends/prediction techniques from volunteers’ behavior; moreover, they quantitatively compare different MCS task assignment strategies based on large-scale and real MCS data campaigns run in the ParticipAct living lab, an ongoing MCS real-world experiment that involved more than 170 students of the University of Bologna for more than one year.

  6. Organizing the Donation of Convalescent Plasma for a Therapeutic Clinical Trial on Ebola Virus Disease: The Experience in Guinea

    Science.gov (United States)

    Delamou, Alexandre; Haba, Nyankoye Yves; Mari-Saez, Almudena; Gallian, Pierre; Ronse, Maya; Jacobs, Jan; Camara, Bienvenu Salim; Kadio, Kadio Jean-Jacques Olivier; Guemou, Achille; Kolie, Jean Pe; De Crop, Maaike; Chavarin, Patricia; Jacquot, Chantal; Lazaygues, Catherine; De Weggheleire, Anja; Lynen, Lutgarde; van Griensven, Johan

    2016-01-01

    Although convalescent plasma (CP) transfusion was prioritized among potential Ebola treatments by the World Health Organization, there were concerns on the feasibility of its implementation. We report on the successful organization of donor mobilization and plasma collection as part of the Ebola-Tx clinical trial from November 2014 to July 2015 in Conakry, Guinea. Project implementation registers, tools and reports, mission reports, and minutes of research team meetings were used to reconstruct the sequence of events on how donor mobilization was organized, plasmapheresis was set up, and how effective this approach was in collecting CP. An initial needs assessment of the Guinean National Blood Transfusion Center resulted in targeted training of staff on site, resulting in autonomy and independent production of CP within 3 months. The Conakry Ebola Survivors Association played a direct role in donor mobilization and organization of CP donations. A total of 98 Ebola survivors were screened for plasma donation, of which 84 were found eligible for plasmapheresis. Of these, 26 (30.9%) were excluded. The remaining 58 donors made a total of 90 donations, corresponding to 50.9 L of CP. This sufficed to treat the 99 eligible patients enrolled in the trial. Within a poor resource emergency context, transfusion capacity could be rapidly improved through the strengthening of local capacities and gradual transfer of skills coupled with active involvement of Ebola survivors. However, large-scale plasma collection or multisite studies may require further adaptations of both strategy and logistics. The Ebola-Tx trial was funded by the European Union and others. PMID:27430546

  7. Nonresponse bias in randomized controlled experiments in criminology: Putting the Queensland Community Engagement Trial (QCET) under a microscope.

    Science.gov (United States)

    Antrobus, Emma; Elffers, Henk; White, Gentry; Mazerolle, Lorraine

    2013-01-01

    The goal of this article is to examine whether or not the results of the Queensland Community Engagement Trial (QCET)-a randomized controlled trial that tested the impact of procedural justice policing on citizen attitudes toward police-were affected by different types of nonresponse bias. We use two methods (Cochrane and Elffers methods) to explore nonresponse bias: First, we assess the impact of the low response rate by examining the effects of nonresponse group differences between the experimental and control conditions and pooled variance under different scenarios. Second, we assess the degree to which item response rates are influenced by the control and experimental conditions. Our analysis of the QCET data suggests that our substantive findings are not influenced by the low response rate in the trial. The results are robust even under extreme conditions, and statistical significance of the results would only be compromised in cases where the pooled variance was much larger for the nonresponse group and the difference between experimental and control conditions was greatly diminished. We also find that there were no biases in the item response rates across the experimental and control conditions. RCTs that involve field survey responses-like QCET-are potentially compromised by low response rates and how item response rates might be influenced by the control or experimental conditions. Our results show that the QCET results were not sensitive to the overall low response rate across the experimental and control conditions and the item response rates were not significantly different across the experimental and control groups. Overall, our analysis suggests that the results of QCET are robust and any biases in the survey responses do not significantly influence the main experimental findings.

  8. Organizing the Donation of Convalescent Plasma for a Therapeutic Clinical Trial on Ebola Virus Disease: The Experience in Guinea.

    Science.gov (United States)

    Delamou, Alexandre; Haba, Nyankoye Yves; Mari-Saez, Almudena; Gallian, Pierre; Ronse, Maya; Jacobs, Jan; Camara, Bienvenu Salim; Kadio, Kadio Jean-Jacques Olivier; Guemou, Achille; Kolie, Jean Pe; Crop, Maaike De; Chavarin, Patricia; Jacquot, Chantal; Lazaygues, Catherine; Weggheleire, Anja De; Lynen, Lutgarde; van Griensven, Johan

    2016-09-01

    Although convalescent plasma (CP) transfusion was prioritized among potential Ebola treatments by the World Health Organization, there were concerns on the feasibility of its implementation. We report on the successful organization of donor mobilization and plasma collection as part of the Ebola-Tx clinical trial from November 2014 to July 2015 in Conakry, Guinea. Project implementation registers, tools and reports, mission reports, and minutes of research team meetings were used to reconstruct the sequence of events on how donor mobilization was organized, plasmapheresis was set up, and how effective this approach was in collecting CP. An initial needs assessment of the Guinean National Blood Transfusion Center resulted in targeted training of staff on site, resulting in autonomy and independent production of CP within 3 months. The Conakry Ebola Survivors Association played a direct role in donor mobilization and organization of CP donations. A total of 98 Ebola survivors were screened for plasma donation, of which 84 were found eligible for plasmapheresis. Of these, 26 (30.9%) were excluded. The remaining 58 donors made a total of 90 donations, corresponding to 50.9 L of CP. This sufficed to treat the 99 eligible patients enrolled in the trial. Within a poor resource emergency context, transfusion capacity could be rapidly improved through the strengthening of local capacities and gradual transfer of skills coupled with active involvement of Ebola survivors. However, large-scale plasma collection or multisite studies may require further adaptations of both strategy and logistics. The Ebola-Tx trial was funded by the European Union and others.

  9. Which treatment for low back pain? A factorial randomised controlled trial comparing intravenous analgesics with oral analgesics in the emergency department and a centrally acting muscle relaxant with placebo over three days [ISRCTN09719705].

    Science.gov (United States)

    Havel, Christof; Sieder, Anna; Herkner, Harald; Domanovits, Hans; Schmied, Mascha; Segel, Rudolf; Koreny, Maria; Laggner, Anton N; Müllner, Marcus

    2001-01-01

    BACKGROUND: About two thirds of adults suffer from backpain at some time during their life. In the emergency room many patients with acute back pain are treated with intravenous non-steroidal analgesics. Whether this treatment is superior to oral administration of non-steroidal analgesics is unknown. Intravenous administration, however, requires considerable amounts of resources and accounts for high workload in busy clinics. In the further course centrally acting muscle relaxants are prescribed but the effectiveness remains unclear. The objective of this study is on the one hand to compare the effectiveness of intravenous with oral non-steroidal analgesics for acute treatment and on the other hand to compare the effectiveness of a centrally active muscle relaxant with placebo given for three days after presentation to the ED (emergency department). METHODS/DESIGN: This study is intended as a randomised controlled factorial trial mainly for two reasons: (1) the sequence of treatments resembles the actual proceedings in every-day clinical practice, which is important for the generalisability of the results and (2) this design allows to take interactions between the two sequential treatment strategies into account. There is a patient preference arm included because patients preference is an important issue providing valuable information: (1) it allows to assess the interaction between desired treatment and outcome, (2) results can be extrapolated to a wider group while (3) conserving the advantages of a fully randomised controlled trial. CONCLUSION: We hope to shed more light on the effectiveness of treatment modalities available for acute low back pain.

  10. Which treatment for low back pain? A factorial randomised controlled trial comparing intravenous analgesics with oral analgesics in the emergency department and a centrally acting muscle relaxant with placebo over three days [ISRCTN09719705

    Directory of Open Access Journals (Sweden)

    Koreny Maria

    2001-11-01

    Full Text Available Abstract Background About two thirds of adults suffer from backpain at some time during their life. In the emergency room many patients with acute back pain are treated with intravenous non-steroidal analgesics. Whether this treatment is superior to oral administration of non-steroidal analgesics is unknown. Intravenous administration, however, requires considerable amounts of resources and accounts for high workload in busy clinics. In the further course centrally acting muscle relaxants are prescribed but the effectiveness remains unclear. The objective of this study is on the one hand to compare the effectiveness of intravenous with oral non-steroidal analgesics for acute treatment and on the other hand to compare the effectiveness of a centrally active muscle relaxant with placebo given for three days after presentation to the ED (emergency department. Methods/Design This study is intended as a randomised controlled factorial trial mainly for two reasons: (1 the sequence of treatments resembles the actual proceedings in every-day clinical practice, which is important for the generalisability of the results and (2 this design allows to take interactions between the two sequential treatment strategies into account. There is a patient preference arm included because patients preference is an important issue providing valuable information: (1 it allows to assess the interaction between desired treatment and outcome, (2 results can be extrapolated to a wider group while (3 conserving the advantages of a fully randomised controlled trial. Conclusion We hope to shed more light on the effectiveness of treatment modalities available for acute low back pain.

  11. Does oral polio vaccine have non-specific effects on all-cause mortality? Natural experiments within a randomised controlled trial of early measles vaccine

    Science.gov (United States)

    Aaby, Peter; Andersen, Andreas; Martins, Cesário L; Fisker, Ane B; Rodrigues, Amabelia; Whittle, Hilton C; Benn, Christine S

    2016-01-01

    Background BCG and measles vaccine (MV) may have beneficial non-specific effects (NSEs). If an unplanned intervention with a vaccine (a natural experiment) modifies the estimated effect in a randomised controlled trial (RCT), this suggests NSEs. We used this approach to test NSEs of triple oral polio vaccine (OPV). Methods During an RCT of 2 doses of MV at 4.5 and 9 months versus 1 dose of MV at 9 months of age, we experienced 2 natural experiments with OPV. We assessed whether these OPV experiments modified the effect of 2-dose MV in the MV trial. Setting MV RCT conducted in urban Guinea-Bissau 2003–2009. Interventions Natural experiments with OPV due to missing vaccine and the implementation of OPV campaigns. Main outcome measure Changes in the mortality rate ratio (MRR) for 2-dose MV versus 1-dose MV. Results First, the MRR (2-dose/1-dose MV) overall was 0.70 (0.52 to 0.94), but the MRR was 1.04 (0.53 to 2.04) when OPV at birth (OPV0) was not given, suggesting that early priming with OPV was important for the effect of 2-dose MV. The effect of OPV0 depended on age of administration; the MRR (2-dose/1-dose MV) was 0.45 (0.29 to 0.71) for children receiving OPV0 in the first week of life, but 3.63 (0.87 to 15.2) for those receiving OPV0 after the first month of life (p=0.007, test of no interaction). Second, campaign-OPV may have reduced the difference between the randomisation groups since the MRR (2-dose/1-dose MV) was 0.60 (0.42 to 0.85) for children who had not received campaign-OPV before RCT-enrolment versus 0.72 (0.23 to 2.31) and 1.42 (0.70 to 2.90) for children who had received 1 or 2 doses of campaign-OPV-before-enrolment, respectively. Conclusions Bissau had no polio infection during this trial, so OPV0 and campaign-OPV may have NSEs since they modified the effect of 2-dose MV in an RCT. Different interventions may interact to a much larger effect than usually assumed. PMID:28011813

  12. Conversation, speech acts, and memory.

    Science.gov (United States)

    Holtgraves, Thomas

    2008-03-01

    Speakers frequently have specific intentions that they want others to recognize (Grice, 1957). These specific intentions can be viewed as speech acts (Searle, 1969), and I argue that they play a role in long-term memory for conversation utterances. Five experiments were conducted to examine this idea. Participants in all experiments read scenarios ending with either a target utterance that performed a specific speech act (brag, beg, etc.) or a carefully matched control. Participants were more likely to falsely recall and recognize speech act verbs after having read the speech act version than after having read the control version, and the speech act verbs served as better recall cues for the speech act utterances than for the controls. Experiment 5 documented individual differences in the encoding of speech act verbs. The results suggest that people recognize and retain the actions that people perform with their utterances and that this is one of the organizing principles of conversation memory.

  13. Usability of a novel disposable autoinjector device for ixekizumab: results from a qualitative study and an open-label clinical trial, including patient-reported experience

    Directory of Open Access Journals (Sweden)

    Callis Duffin K

    2016-10-01

    Full Text Available Kristina Callis Duffin,1 Michael Bukhalo,2 Margaret A Bobonich,3 David Shrom,4 Fangyi Zhao,4 James R Kershner,4 Anne Gill,4 Beth Pangallo,4 Catherine L Shuler,4 Jerry Bagel5 1Department of Dermatology, University of Utah School of Medicine, Salt Lake City, UT, 2Arlington Dermatology, Arlington Heights, IL, 3CWRU Schools of Medicine and Nursing, Case Western Reserve University Cleveland, OH, 4Lilly Research Labs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 5Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, USA Background: Most biologic therapies for psoriasis are delivered via subcutaneous injection. Ixekizumab, an anti-interleukin 17A monoclonal antibody approved for patients with moderate-to-severe plaque psoriasis, is delivered subcutaneously via prefilled syringe or autoinjector. Here we report the results of an ixekizumab autoinjector usability study as well as the patient-reported experience with the autoinjector in a clinical trial. Methods: The usability study enrolled 49 subjects (patients with a range of autoimmune conditions or their caregivers. Subjects were randomized to a trained or untrained group and were evaluated for their ability to perform an injection successfully when provided the device and the instructions for use. In the clinical trial, 102 subjects (patients with psoriasis or their caregivers used the autoinjector to deliver injections of ixekizumab (80 mg every 2 weeks after a starting dose of 160 mg. At weeks 0, 4, and 8, subjects completed the subcutaneous administration assessment questionnaire, which assesses the ease of use and confidence with using an injection device. Results: In the usability study, all subjects in the untrained arm performed successful injections, while two subjects in the trained arm had an injection failure. These incidences were not consistent with any pattern of issues with the device or the instructions for use. In the clinical trial, there were two

  14. Supplemental vibrational force does not reduce pain experience during initial alignment with fixed orthodontic appliances: a multicenter randomized clinical trial.

    Science.gov (United States)

    Woodhouse, Neil R; DiBiase, Andrew T; Papageorgiou, Spyridon N; Johnson, Nicola; Slipper, Carmel; Grant, James; Alsaleh, Maryam; Cobourne, Martyn T

    2015-11-27

    This prospective randomized trial investigated the effect of supplemental vibrational force on orthodontic pain during alignment with fixed-appliances. Eighty-one subjects analgesics reported slightly higher maximum-pain although this was not significant (P = 0.170). The effect of intervention was independent of analgesia (P = 0.883). At T1 and T2, a statistically and clinically significant increase in mean pain was seen at 4 and 24-hours, declining at 72-hours and becoming insignificant at 1-week. For mean alignment-rate, pain-intensity and use of analgesics, no significant differences existed between groups (P > 0.003). The only significant predictor for mean pain was time. Use of an AcceleDent vibrational device had no significant effect on orthodontic pain or analgesia consumption during initial alignment with fixed appliances.

  15. Impact of mothers' employment on infant feeding and care: a qualitative study of the experiences of mothers employed through the Mahatma Gandhi National Rural Employment Guarantee Act.

    Science.gov (United States)

    Nair, Manisha; Ariana, Proochista; Webster, Premila

    2014-04-02

    To explore the experiences of mothers employed through the Mahatma Gandhi National Rural Employment Guarantee Act (MGNREGA) using focus group discussions (FGDs) to understand the impact of mothers' employment on infant feeding and care. The effects of mothers' employment on nutritional status of children could be variable. It could lead to increased household income, but could also compromise child care and feeding. The study was undertaken in the Dungarpur district of Rajasthan, India. Mothers of infants <12 months of age. Ten FGDs, two in each of the five administrative blocks of the study district were conducted. The groups were composed of a minimum of 5 and maximum of 8 participants, giving a total of 62 mothers. Thematic analysis was conducted to assess patterns and generate emergent themes. Four major themes were identified-'mothers' employment compromises infant feeding and care', 'caregivers' inability to substitute mothers' care', 'compromises related to childcare and feeding outweigh benefits from MGNREGA' and 'employment as disempowering'. Mothers felt that the comprises to infant care and feeding due to long hours of work, lack of alternative adequate care arrangements, low wages and delayed payments outweighed the benefits from the scheme. This study provides an account of the trade-off between mothers' employment and child care. It provides an understanding of the household power relationships, societal and cultural factors that modulate the effects of mothers' employment. From the perspective of mothers, it helps to understand the benefits and problems related to providing employment to women with infants in the MGNREGA scheme and make a case to pursue policy changes to improve their working conditions.

  16. A double-blind randomised, placebo-controlled trial evaluating the influence of oral long-acting muscle relaxant (Mebeverine MR), and insufflation with CO{sub 2} on pain associated with barium enema

    Energy Technology Data Exchange (ETDEWEB)

    Lowe, A.S.; Chapman, A.H.; Wilson, D.; Culpan, A.G. [Department of Radiology, St. James' s University Hospital, Beckett Street, LS9 7TF, Leeds (United Kingdom)

    2003-07-01

    Previous investigators have shown significant benefit using CO{sub 2} for bowel insufflation. Others have suggested that the long-acting smooth muscle relaxant, Mebeverine, may be of benefit. We subjected this to a randomised double-blind trial. A total of 181 outpatients were randomised to receive either Mebeverine or placebo as pre-medication, and either air or CO{sub 2} for bowel insufflation, thus creating four treatment groups. Visual-analogue lines were used to record pain scores before, during, and up to 8 h following the enema. All groups showed increased pain scores during the enema, with peak pain scores at the end of the examination, falling to baseline scores by 8 h. Patients receiving the combination of C0{sub 2} and placebo had significantly lower pain scores at 1 and 4 h (P=0.00 and P=0.014, respectively; Kruskal-Wallis test) compared with all other groups. Having Mebeverine as a pre-medication did not significantly lower pain scores compared with placebo, and decreased the amount of benefit received from the CO{sub 2}. We confirm that CO{sub 2} is of benefit in decreasing pain during barium enema, and we recommend its routine use to improve the comfort of patients. Mebeverine is not of benefit, and its use as a pre-medication for enemas is not recommended. (orig.)

  17. 民营医院药物临床试验机构建设%Experience on construction of drug clinical trials institution

    Institute of Scientific and Technical Information of China (English)

    周巧霞; 鲁继光; 王之敏; 刘峰

    2014-01-01

    The drug clinical trials are benefit in increasing the level of scientific research and medical quality for hospital. But private hospitals are lack of experiences in application of drug clinical trials institution. In the paper, we made ??a detailed introduction about the construction of drug clinical trial institution in our hospital.It is noted that the support of local government and hospital, building of institution office, construction of the Ethics Committee, establishment of quality control system, development of human resource, construction of clinical professional departments, preparation of material, notices on-site inspection.%药物临床试验机构的申请设立对于医疗机构科研和医疗质量的提高均具有深远的意义,民营医院也应积极加入到申请设立的行列中。但是民营医院申请药物临床试验机构资格认定的案例比较少,缺乏可借鉴的经验。本文从当地政府和医院的政策支持、机构办公室建设、伦理委员会建设、质控体系建立、人才建设、各专业科室的内部建设、材料的准备、现场检查时的注意事项等8个方面对苏州九龙医院药物临床试验机构申请工作做了详细的介绍。

  18. Use of angiotensin II receptor blockers alone and in combination with other drugs: a large clinical experience trial

    Directory of Open Access Journals (Sweden)

    Matthew R Weir

    2001-03-01

    Full Text Available Angiotensin II (Ang II receptor blockers are the newest class of antihypertensive drugs to be developed. No large-scale clinical trials have been performed to evaluate their efficacy alone, or in combination with other drugs. A large-scale, eight week, open-label, non-placebo-controlled, single-arm trial evaluated the efficacy, tolerability and dose-response of candesartan cilexetil, 16—32 mg once-daily, either as monotherapy or as part of combination therapy, in a diverse hypertensive population in actual practice settings. 6465 patients with high blood pressure, of whom 52% were female and 16% African American, with a mean age of 58 years, were included. 5446 patients had essential hypertension and 1014 patients had isolated systolic hypertension. In order to be included in this study, patients had either untreated or uncontrolled hypertension (systolic blood pressure (SBP 140—179 mmHg and/or diastolic blood pressure (DBP 90—109 mmHg inclusive at baseline, despite a variety of other antihypertensive drugs. Of the 5156 patients with essential hypertension and at least one post baseline efficacy measurement, the mean pretreatment blood pressure (BP was 156/97 mmHg. Candesartan cilexetil monotherapy reduced mean SBP/DBP by 18.0/12.2 mmHg. Similarly, in the 964 patients with isolated systolic hypertension and at least one post baseline efficacy measurement, candesartan cilexetil monotherapy reduced SBP/DBP from 158/81 by 16.5/4.5 mmHg. Candesartan cilexetil was similarly effective when employed as add-on therapy. When added to baseline antihypertensive medication in 51% of the patients with essential hypertension not achieving BP control, additional reduction in BP was achieved regardless of the background therapy, including diuretics (17.8/11.7 mmHg calcium antagonists (16.6/11.2 mmHg, beta-blockers (16.5/10.4 mmHg, angiotensin-converting enzyme inhibitors (ACE-I (15.3/10.0 mmHg, and alpha blockers (16.4/10.4 mmHg. Likewise, when

  19. Acceptability of an open-label wait-listed trial design: Experiences from the PROUD PrEP study

    Science.gov (United States)

    Brodnicki, Elizabeth; Desai, Monica; McCormack, Sheena; Nutland, Will; Wayal, Sonali; White, Ellen; Wood, Gemma; Barber, Tristan; Bell, Gill; Clarke, Amanda; Dolling, David; Dunn, David; Fox, Julie; Haddow, Lewis; Lacey, Charles; Nardone, Anthony; Quinn, Killian; Rae, Caroline; Reeves, Iain; Rayment, Michael; White, David; Apea, Vanessa; Ayap, Wilbert; Dewsnap, Claire; Collaco-Moraes, Yolanda; Schembri, Gabriel; Sowunmi, Yinka; Horne, Rob

    2017-01-01

    Background PROUD participants were randomly assigned to receive pre-exposure prophylaxis (PrEP) immediately or after a deferred period of one-year. We report on the acceptability of this open-label wait-listed trial design. Methods Participants completed an acceptability questionnaire, which included categorical study acceptability data and free-text data on most and least liked aspects of the study. We also conducted in-depth interviews (IDI) with a purposely selected sub-sample of participants. Results Acceptability questionnaires were completed by 76% (415/544) of participants. After controlling for age, immediate-group participants were almost twice as likely as deferred-group participants to complete the questionnaire (AOR:1.86;95%CI:1.24,2.81). In quantitative data, the majority of participants in both groups found the wait-listed design acceptable when measured by satisfaction of joining the study, intention to remain in the study, and interest in joining a subsequent study. However, three-quarters thought that the chance of being in the deferred-group might put other volunteers off joining the study. In free-text responses, data collection tools were the most frequently reported least liked aspect of the study. A fifth of deferred participants reported ‘being deferred’ as the thing they least liked about the study. However, more deferred participants disliked the data collection tools than the fact that they had to wait a year to access PrEP. Participants in the IDIs had a good understanding of the rationale for the open-label wait-listed study design. Most accepted the design but acknowledged they were, or would have been, disappointed to be randomised to the deferred group. Five of the 25 participants interviewed reported some objection to the wait-listed design. Conclusion The quantitative and qualitative findings suggest that in an environment where PrEP was not available, the rationale for the wait-listed trial design was well understood and

  20. A sense of security: Spouses’ experiences of participating in an orthopaedic case management intervention (the SICAM-trial)

    DEFF Research Database (Denmark)

    Bøttcher Berthelsen, Connie; Kristensson, Jimmie

    2017-01-01

    The aim of the study was to explore and describe spouses' experiences of participating in a case management intervention during older patients' fast-track programme having total hip replacement as well as which intervention elements they found useful. Data were collected through qualitative inter...

  1. Effects of natural childbirth preparation versus standard antenatal education on epidural rates, experience of childbirth and parental stress in mothers and fathers: a randomised controlled multicentre trial

    Science.gov (United States)

    Bergström, M; Kieler, H; Waldenström, U

    2009-01-01

    Objective To examine the effects of antenatal education focussing on natural childbirth preparation with psychoprophylactic training versus standard antenatal education on the use of epidural analgesia, experience of childbirth and parental stress in first-time mothers and fathers. Design Randomised controlled multicentre trial. Setting Fifteen antenatal clinics in Sweden between January 2006 and May 2007. Sample A total of 1087 nulliparous women and 1064 of their partners. Methods Natural group: Antenatal education focussing on natural childbirth preparation with training in breathing and relaxation techniques (psychoprophylaxis). Standard care group: Standard antenatal education focussing on both childbirth and parenthood, without psychoprophylactic training. Both groups: Four 2-hour sessions in groups of 12 participants during third trimester of pregnancy and one follow-up after delivery. Main outcome measures Epidural analgesia during labour, experience of childbirth as measured by the Wijma Delivery Experience Questionnaire (B), and parental stress measured by the Swedish Parenthood Stress Questionnaire. Results The epidural rate was 52% in both groups. There were no statistically significant differences in the experience of childbirth or parental stress between the randomised groups, either in women or men. Seventy percent of the women in the Natural group reported having used psychoprophylaxis during labour. A minority in the Standard care group (37%) had also used this method, but subgroup analysis where these women were excluded did not change the principal findings. Conclusion Natural childbirth preparation including training in breathing and relaxation did not decrease the use of epidural analgesia during labour, nor did it improve the birth experience or affect parental stress in early parenthood in nulliparous women and men, compared with a standard form of antenatal education. PMID:19538406

  2. Database " I&D”" First Experience with Microisis Software, Version 3.0 Multi-Trial Version-

    OpenAIRE

    Chacón Alvarado, Lucía; Miranda Arguedas, Alice

    2011-01-01

    Standardization facilitates communication and enables the exchange of information with any national or international. This goal is possible through communication formats for automated information exchange as ECLAC, MARC., FCC. The School of Library, Documentation and Information of the National University MICROISIS software used for teaching network. The databases are designed using the MARC format and AACR2 bibliographic description. We report our experience with the database "R & D" on rur...

  3. Common data elements for substance use disorders in electronic health records: the NIDA Clinical Trials Network experience.

    Science.gov (United States)

    Ghitza, Udi E; Gore-Langton, Robert E; Lindblad, Robert; Shide, David; Subramaniam, Geetha; Tai, Betty

    2013-01-01

    Electronic health records (EHRs) are essential in improving quality and enhancing efficiency of health-care delivery. By 2015, medical care receiving service reimbursement from US Centers for Medicare and Medicaid Services (CMS) must show 'meaningful use' of EHRs. Substance use disorders (SUD) are grossly under-detected and under-treated in current US medical care settings. Hence, an urgent need exists for improved identification of and clinical intervention for SUD in medical settings. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) has leveraged its infrastructure and expertise and brought relevant stakeholders together to develop consensus on brief screening and initial assessment tools for SUD in general medical settings, with the objective of incorporation into US EHRs. Stakeholders were identified and queried for input and consensus on validated screening and assessment for SUD in general medical settings to develop common data elements to serve as shared resources for EHRs on screening, brief intervention and referral to treatment (SBIRT), with the intent of supporting interoperability and data exchange in a developing Nationwide Health Information Network. Through consensus of input from stakeholders, a validated screening and brief assessment instrument, supported by Clinical Decision Support tools, was chosen to be used at out-patient general medical settings. The creation and adoption of a core set of validated common data elements and the inclusion of such consensus-based data elements for general medical settings will enable the integration of SUD treatment within mainstream health care, and support the adoption and 'meaningful use' of the US Office of the National Coordinator for Health Information Technology (ONC)-certified EHRs, as well as CMS reimbursement. Published 2012. This article is a U.S. Government work and is in the public domain in the USA.

  4. Consuming a Ketogenic Diet while Receiving Radiation and Chemotherapy for Locally Advanced Lung Cancer and Pancreatic Cancer: The University of Iowa Experience of Two Phase 1 Clinical Trials.

    Science.gov (United States)

    Zahra, Amir; Fath, Melissa A; Opat, Emyleigh; Mapuskar, Kranti A; Bhatia, Sudershan K; Ma, Daniel C; Iii, Samuel N Rodman; Snyders, Travis P; Chenard, Catherine A; Eichenberger-Gilmore, Julie M; Bodeker, Kellie L; Ahmann, Logan; Smith, Brian J; Vollstedt, Sandy A; Brown, Heather A; Hejleh, Taher Abu; Clamon, Gerald H; Berg, Daniel J; Szweda, Luke I; Spitz, Douglas R; Buatti, John M; Allen, Bryan G

    2017-06-01

    Ketogenic diets are low in carbohydrates and high in fat, which forces cells to rely more heavily upon mitochondrial oxidation of fatty acids for energy. Relative to normal cells, cancer cells are believed to exist under a condition of chronic mitochondrial oxidative stress that is compensated for by increases in glucose metabolism to generate reducing equivalents. In this study we tested the hypothesis that a ketogenic diet concurrent with radiation and chemotherapy would be clinically tolerable in locally advanced non-small cell lung cancer (NSCLC) and pancreatic cancer and could potentially exploit cancer cell oxidative metabolism to improve therapeutic outcomes. Mice bearing MIA PaCa-2 pancreatic cancer xenografts were fed either a ketogenic diet or standard rodent chow, treated with conventionally fractionated radiation (2 Gy/fraction), and tumor growth rates were assessed daily. Tumors were assessed for immunoreactive 4-hydroxy-2-nonenal-(4HNE)-modfied proteins as a marker of oxidative stress. Based on this and another previously published preclinical study, phase 1 clinical trials in locally advanced NSCLC and pancreatic cancer were initiated, combining standard radiation and chemotherapy with a ketogenic diet for six weeks (NSCLC) or five weeks (pancreatic cancer). The xenograft experiments demonstrated prolonged survival and increased 4HNE-modfied proteins in animals consuming a ketogenic diet combined with radiation compared to radiation alone. In the phase 1 clinical trial, over a period of three years, seven NSCLC patients enrolled in the study. Of these, four were unable to comply with the diet and withdrew, two completed the study and one was withdrawn due to a dose-limiting toxicity. Over the same time period, two pancreatic cancer patients enrolled in the trial. Of these, one completed the study and the other was withdrawn due to a dose-limiting toxicity. The preclinical experiments demonstrate that a ketogenic diet increases radiation sensitivity

  5. Balancing Acts

    Science.gov (United States)

    ... Past Issues Special Section: Focus on Communication Balancing Acts Past Issues / Fall 2008 Table of Contents For ... scientific research on hearing, balance, smell, taste, voice, speech, and language—common elements in how we perceive ...

  6. What are People's Experiences of a Novel Cognitive Behavioural Therapy for Bipolar Disorders? A Qualitative Investigation with Participants on the TEAMS Trial.

    Science.gov (United States)

    Joyce, Emmeline; Tai, Sara; Gebbia, Piersanti; Mansell, Warren

    2017-05-01

    Background Psychological interventions for bipolar disorders typically produce mixed outcomes and modest effects. The need for a more effective intervention prompted the development of a new cognitive behavioural therapy, based on an integrative cognitive model ('Think Effectively About Mood Swings' [TEAMS] therapy). Unlike previous interventions, TEAMS addresses current symptoms and comorbidities, and helps clients achieve long-term goals. A pilot randomized controlled trial (the TEAMS trial) of the therapy has recently concluded. This study explored participants' experiences of TEAMS, recommendations for improvement and experiences of useful changes post-therapy. Methods Fourteen TEAMS therapy participants took part in semi-structured interviews. Their accounts were analysed using interpretative thematic analysis. Two researchers coded the dataset independently. Member checks were conducted of the preliminary themes. Results Two overarching themes; 'useful elements of therapy' and 'changes from therapy' encompassed 12 emerging subthemes. Participants appreciated having opportunities to talk and described the therapy as person-centred and delivered by caring, approachable and skilled therapists. Some recommended more sessions than the 16 provided. Helpful therapeutic techniques were reported to be, normalization about moods, methods to increase understanding of moods, relapse-prevention, reappraisal techniques and metaphors. However, some did not find therapeutic techniques helpful. Post-therapy, many reported changes in managing mood swings more effectively and in their thinking (although some participants reported changes in neither). Many described increased acceptance of themselves and of having bipolar disorder, increased productivity and reduced anxiety in social situations. Conclusions The present study evaluates participants' therapy experiences in detail, including aspects of therapy viewed as helpful, and meaningful post-therapy outcomes. Copyright

  7. Missed Opportunities for TB Investigation in Primary Care Clinics in South Africa: Experience from the XTEND Trial.

    Directory of Open Access Journals (Sweden)

    Violet N Chihota

    Full Text Available 40 primary health clinics (PHCs in four provinces in South Africa, June 2012 -February 2013.To determine whether health care worker (HCW practice in investigating people with TB symptoms was altered when the initial test for TB was changed from smear microscopy to Xpert MTB/RIF.Cross-sectional substudy at clinics participating in a pragmatic cluster randomised trial, Xpert for TB: Evaluating a New Diagnostic "XTEND", which evaluated the effect of Xpert MTB/RIF implementation in South Africa.Consecutive adults exiting PHCs reporting at least one TB symptom (defined as any of cough, weight loss, night sweats and fever were enrolled. The main outcome was the proportion who self-reported having sputum requested by HCW during the clinic encounter just completed.3604 adults exiting PHCs (1676 in Xpert arm, 1928 in microscopy arm were enrolled (median age 38 years, 71.4% female, 38.8% reported being HIV-positive, 70% reported cough. For 1267 participants (35.2% the main reason for attending the clinic was TB symptom(s. Overall 2130/3604 (59.1% said they reported their symptom(s to HCW. 22.7% (818/3604 reported having been asked to give sputum for TB investigation. Though participants in the Xpert vs. microscopy arm were more likely to have sputum requested by HCW, this was not significantly different: overall (26.0% [436/1676] vs 19.8% [382/1928]; adjusted prevalence ratio [aPR] 1.31, [95% CI 0.78-2.20] and when restricted to those presenting at clinics due to symptoms (49.1% [260/530] vs 29.9% [220/737]; aPR 1.38 [0.89-2.13] and those reporting being HIV-positive (29.4% [190/647] vs 20.8% [156/749]; aPR 1.38[0.88-2.16]. Those attending clinic due to TB symptoms, were more likely to have sputum requested if they had increasing number of symptoms; longer duration of cough, unintentional weight loss and night sweats and if they reported symptoms to HCW.A large proportion of people exiting PHCs reporting TB symptoms did not get tested. Implementation of

  8. Experience with tocilizumab in patients with rheumatoid arthritis (according to the data of the LORNET multicenter trial

    Directory of Open Access Journals (Sweden)

    E Yu Panasyuk

    2013-01-01

    Full Text Available Objective: to estimate quality of life changes in patients with rheumatoid arthritis (RA while adding tocilizumab (TCZ to therapy with disease-modifying antirheumatic drugs (DMARDs and to study the efficiency and safety of the therapy in RA patients with an inadequate response to previous DMARD treatment. Subjects and methods. 201 patients with RA were examined. All the patients received six intravenous infusions of TCZ 8 mg/kg at a 4-week interval during stable therapy with DMARDs and glucocorticoids. The EULAR/ACR classification criteria and SDAI and CDAI were used to evaluate the efficiency of TCZ therapy. Remission was assessed by the EULAR criteria. Results and discussion. Prior to TCZ therapy, median [25th to 75th percentiles] DAS28 6.8 [6.1 to 7.4], SDAI 41.8 [34.6 to 53.7], and CDAI 39.2 [31.4 to 49.5] corresponded to high RA activity. At week 4 of TCZ therapy, there was a reduction in DAS28 (4.6 [3.8 to 5.4], SDAI (24.6 [17.8 to 33.4], and CDAI (23.6 [17.5 to 32.0], which was retained until 24 weeks (р < 0.01. At week 24 of TCZ therapy, good and fair effects according to the EULAR criteria were observed in 133 (70.4% and 54 (28.6% patients, respectively; no effect was seen in 2 (1.1% patients. The ACR20/50/70 effect was recorded in 89.1, 70.6, and 44.3% of the patients, respectively. EULAR and SDAI remissions were achieved in 51.3 and 21.4%, respectively. There were improvements in functional status and quality of life according to the EQ-5D and SF-36 questionnaires. C-reactive protein levels and erythrocyte sedimentation rate normalized 4 weeks after the first infusion of the drug and remained until week 24 of treatment. Conclusion. Thus, an analysis of the data of the Russian trial convincingly suggests that TCZ is effective and well tolerated in severe RA resistant to standard therapy with DMARDs.

  9. Developing and evaluating interventions to reduce inappropriate prescribing by general practitioners of antibiotics for upper respiratory tract infections: A randomised controlled trial to compare paper-based and web-based modelling experiments

    Directory of Open Access Journals (Sweden)

    Sullivan Frank

    2011-03-01

    Full Text Available Abstract Background Much implementation research is focused on full-scale trials with little evidence of preceding modelling work. The Medical Research Council Framework for developing and evaluating complex interventions has argued for more and better theoretical and exploratory work prior to a trial as a means of improving intervention development. Intervention modelling experiments (IMEs are a way of exploring and refining an intervention before moving to a full-scale trial. They do this by delivering key elements of the intervention in a simulation that approximates clinical practice by, for example, presenting general practitioners (GPs with a clinical scenario about making a treatment decision. Methods The current proposal will run a full, web-based IME involving 250 GPs that will advance the methodology of IMEs by directly comparing results with an earlier paper-based IME. Moreover, the web-based IME will evaluate an intervention that can be put into a full-scale trial that aims to reduce antibiotic prescribing for upper respiratory tract infections in primary care. The study will also include a trial of email versus postal invitations to participate. Discussion More effective behaviour change interventions are needed and this study will develop one such intervention and a system to model and test future interventions. This system will be applicable to any situation in the National Health Service where behaviour needs to be modified, including interventions aimed directly at the public. Trial registration ClinicalTrials (NCT: NCT01206738

  10. Lumacaftor alone and combined with ivacaftor: preclinical and clinical trial experience of F508del CFTR correction.

    Science.gov (United States)

    Brewington, John J; McPhail, Gary L; Clancy, John P

    2016-01-01

    Cystic fibrosis (CF) is an autosomal recessive disorder caused by mutations in the gene encoding the cystic fibrosis transmembrane conductance regulator protein (CFTR), leading to significant morbidity and mortality. CFTR is a chloride and bicarbonate channel at the epithelial cell membrane. The most common CFTR mutation is F508del, resulting in minimal CFTR at the plasma membrane. Current disease management is supportive, whereas an ultimate goal is to develop therapies to restore CFTR activity. We summarize experience with lumacaftor, a small molecule that increases F508del-CFTR levels at the plasma membrane. Lumacaftor in combination with ivacaftor, a modulator of CFTR gating defects, improves clinical outcome measures in patients homozygous for the F508del mutation. Lumacaftor represents a significant advancement in the treatment of biochemical abnormalities in CF. Further development of CFTR modulators will improve upon current therapies, although it remains unclear whether this approach will provide therapies for all CFTR mutations.

  11. The effect of dignity therapy on distress and end-of-life experience in terminally ill patients: a randomised controlled trial

    Science.gov (United States)

    Chochinov, Harvey Max; Kristjanson, Linda J.; Breitbart, William; McClement, Susan; Hack, Thomas F; Hassard, Tom; Harlos, Mike

    2011-01-01

    Objectives Dignity Therapy is a unique, individualized, brief psychotherapy, developed for patients (and their families) living with life threatening or life limiting illness. The purpose of this study was to determine if Dignity Therapy could mitigate distress and/or bolster end-of-life experience for patients nearing death. Trial Design Multi-site randomized controlled trial, with patients assigned to Dignity Therapy, Client Centred Care or Standard Palliative Care. Study arm assignment was based on a computer-generated table of random numbers. Blinding was achieved using opaque sealed envelopes, containing allocations that were only opened once consent had been obtained. Participants Patients receiving hospital or community (hospice or home) based palliative care, in Winnipeg, New York, or Perth, randomly assigned to, Dignity Therapy [n=108], Client Centered Care [n=107] and Standard Palliative Care (n=111). Main Outcome Measures The primary outcome measures included the FACIT Spiritual Well-Being Scale, the Patient Dignity Inventory, the Hospital Anxiety and Depression Scale; items from the Structured Interview for Symptoms and Concerns, the Quality of Life Scale and a modified Edmonton Symptom Assessment Scale. Mean changes between baseline and end of intervention ratings were determined. Secondary outcomes, examining self-report end-of-life experience, consisted of a post-study survey administered across all study arms. Intervention Dignity Therapy, a novel, brief psychotherapy, provides patients with life threatening and life limiting illnesses an opportunity to speak about things that matter most to them. These recorded conversations form the basis of a generativity document, which patients can bequeath to individuals of their choosing. Client Centred Care is a supportive psychotherapeutic approach, in which research nurse/therapists guide patients through discussions focusing on here and now issues. Findings No significant differences across study arms

  12. Rhythm experience and Africana culture trial (REACT!): A culturally salient intervention to promote neurocognitive health, mood, and well-being in older African Americans

    Science.gov (United States)

    Lukach, Alexis J.; Jedrziewski, M. Kathryn; Grove, George A.; Mechanic-Hamilton, Dawn J.; Williams, Shardae S.; Wollam, Mariegold E.; Erickson, Kirk I.

    2017-01-01

    The Rhythm Experience and Africana Culture Trial (REACT!) is a multi-site randomized controlled intervention study designed to examine the efficacy of using African Dance as a form of moderate-intensity physical activity to improve cognitive function in older African Americans. African Americans are almost two times more likely than Caucasians to experience cognitive impairment in late adulthood. This increased risk may be attributed to lower level and quality of education, lower socioeconomic status, and higher prevalence of vascular diseases, type 2 diabetes, hypertension, and obesity, all of which are recognized as risk factors for dementia. Fortunately, interventions targeting cardiovascular health (i.e., physical activity) are associated with improved neurocognitive function and a reduced risk for dementia, so African Americans may be particularly suited for interventions targeting cardiovascular health and cognitive function. Here, we describe a randomized intervention protocol for increasing physical activity in older (65–75 years) African Americans. Participants (n = 80) at two study locations will be randomized into one of two groups. The treatment group will participate in African Dance three times per week for six months and the control group will receive educational training on Africana history and culture, as well as information about health behaviors, three times per week for six months. If successful, the REACT! study may transform community interventions and serve as a platform and model for testing other populations, age groups, and health outcomes, potentially identifying novel and creative methods for reducing or eliminating health disparities. PMID:27033674

  13. Rhythm experience and Africana culture trial (REACT!): A culturally salient intervention to promote neurocognitive health, mood, and well-being in older African Americans.

    Science.gov (United States)

    Lukach, Alexis J; Jedrziewski, M Kathryn; Grove, George A; Mechanic-Hamilton, Dawn J; Williams, Shardae S; Wollam, Mariegold E; Erickson, Kirk I

    2016-05-01

    The Rhythm Experience and Africana Culture Trial (REACT!) is a multi-site randomized controlled intervention study designed to examine the efficacy of using African Dance as a form of moderate-intensity physical activity to improve cognitive function in older African Americans. African Americans are almost two times more likely than Caucasians to experience cognitive impairment in late adulthood. This increased risk may be attributed to lower level and quality of education, lower socioeconomic status, and higher prevalence of vascular diseases, type 2 diabetes, hypertension, and obesity, all of which are recognized as risk factors for dementia. Fortunately, interventions targeting cardiovascular health (i.e., physical activity) are associated with improved neurocognitive function and a reduced risk for dementia, so African Americans may be particularly suited for interventions targeting cardiovascular health and cognitive function. Here, we describe a randomized intervention protocol for increasing physical activity in older (65-75years) African Americans. Participants (n=80) at two study locations will be randomized into one of two groups. The treatment group will participate in African Dance three times per week for six months and the control group will receive educational training on Africana history and culture, as well as information about health behaviors, three times per week for six months. If successful, the REACT! study may transform community interventions and serve as a platform and model for testing other populations, age groups, and health outcomes, potentially identifying novel and creative methods for reducing or eliminating health disparities. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. The Data Protection Act (1998): implications for health researchers.

    Science.gov (United States)

    Redsell, S A; Cheater, F M

    2001-08-01

    This paper reports on the methods used in two studies to obtain access to subjects to comply with the common law duty of confidence laid out in the Data Protection Act (1998) and discusses the researchers' problems in interpreting the procedures. The amendments to the United Kingdom (UK) Data Protection Act (1998) are causing confusion within the health service and academic institutions. There is a need to balance patient confidentiality with the requirement to conduct vital, unbiased research in which health service professionals are not subject to ethical dilemmas. This paper examines the recruitment methods used in two studies in which the researchers' attempts to adhere to the requirements lengthened the study costs and may have produced less reliable results. The methodological difficulties in two studies are presented. In Study 1, the difficulties encountered when the Multicentre Research Ethics Committee refused permission for researchers to recruit patients directly to a multicentre randomized controlled trial are discussed. In Study 2, the method used to compile a sampling frame for a national questionnaire survey following the eight principles of the Act are described. Our experience has shown that health care professionals are increasingly required to recruit patients to intervention trials, and that researchers are not allowed access to the names of patients or other subjects to ask them for consent to participate in a study. The requirement for researchers to use "intermediaries" to obtain consent from and recruit subjects to studies increases the risk of selection bias, may expose the practitioner to ethical difficulties and may compromise the external validity of trial results. There is also a danger that research costs will soar when the Data Protection Act (1998) is fully realized. The Data Protection Act (1998) is currently being interpreted in a number of different ways. We conclude there is an urgent need for consensus within the health service

  15. Data mining experiments on the Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation (ANTIPAF-AFNET 2) trial: 'exposing the invisible'.

    Science.gov (United States)

    Okutucu, Sercan; Katircioglu-Öztürk, Deniz; Oto, Emre; Güvenir, H Altay; Karaagaoglu, Ergun; Oto, Ali; Meinertz, Thomas; Goette, Andreas

    2017-05-01

    The aims of this study include (i) pursuing data-mining experiments on the Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation (ANTIPAF-AFNET 2) trial dataset containing atrial fibrillation (AF) burden scores of patients with many clinical parameters and (ii) revealing possible correlations between the estimated risk factors of AF and other clinical findings or measurements provided in the dataset. Ranking Instances by Maximizing the Area under a Receiver Operating Characteristics (ROC) Curve (RIMARC) is used to determine the predictive weights (Pw) of baseline variables on the primary endpoint. Chi-square automatic interaction detector algorithm is performed for comparing the results of RIMARC. The primary endpoint of the ANTIPAF-AFNET 2 trial was the percentage of days with documented episodes of paroxysmal AF or with suspected persistent AF. By means of the RIMARC analysis algorithm, baseline SF-12 mental component score (Pw= 0.3597), age (Pw= 0.2865), blood urea nitrogen (BUN) (Pw= 0.2719), systolic blood pressure (Pw= 0.2240), and creatinine level (Pw= 0.1570) of the patients were found to be predictors of AF burden. Atrial fibrillation burden increases as baseline SF-12 mental component score gets lower; systolic blood pressure, BUN and creatinine levels become higher; and the patient gets older. The AF burden increased significantly at age >76. With the ANTIPAF-AFNET 2 dataset, the present data-mining analyses suggest that a baseline SF-12 mental component score, age, systolic blood pressure, BUN, and creatinine level of the patients are predictors of AF burden. Additional studies are necessary to understand the distinct kidney-specific pathophysiological pathways that contribute to AF burden.

  16. Evaluation of the effects of a birth plan on Taiwanese women's childbirth experiences, control and expectations fulfilment: a randomised controlled trial.

    Science.gov (United States)

    Kuo, Su-Chen; Lin, Kuan-Chia; Hsu, Chi-Ho; Yang, Cherng-Chia; Chang, Min-Yu; Tsao, Chien-Ming; Lin, Lie-Chu

    2010-07-01

    In many western countries, pregnant women often prepare birth plans, outlining how they would like their childbirth experiences to proceed. However there have been no experimental studies to evaluate the effect of birth plans. The objective of this research was to evaluate the effects of birth plans on women's fulfilment of their childbirth expectations, their control over the birth process, and overall experiences. A randomised, single-blind controlled trial study design was used. This study involved seven hospitals and 10 obstetricians in Taiwan. Participants included primiparous women, each under the care of one of seven Taiwanese medical facilities, and who had been pregnant for at least 32 weeks. They were also at least 18 years old, and had no pregnancy complications. An exclusion criterion was elective caesarean as a mode of delivery. A total of 296 women in hospital clinics who met the study criteria were allocated by block randomisation to experimental (n=155) or control (n=141) groups. The women completed their basic personal information and a childbirth expectations questionnaire when they were recruited. One day after delivery, all the participants completed a questionnaire about the childbirth experience, control and fulfilment of their childbirth expectations. The experimental group had a statistically higher degree of positive childbirth experiences than that of the control group (t=2.48, p=0.01). The experimental group also showed a higher degree of childbirth control (t=9.60, pcontrol groups in prenatal birth expectations, but a significant difference (t=2.63, p=0.01) in the degree of fulfilment of their childbirth expectations after delivery. On a subscale measuring the fulfilment of childbirth expectations, there was a statistically higher degree of mastery and participation (t=3.74, pcontrol group. The results justify the clinical implementation of birth plans. Providing birth plans in medical facilities is an effective means of fulfilling

  17. Exploring user experience and technology acceptance for a fall prevention system: results from a randomized clinical trial and a living lab.

    Science.gov (United States)

    Vaziri, Daryoush D; Aal, Konstantin; Ogonowski, Corinna; Von Rekowski, Thomas; Kroll, Michael; Marston, Hannah R; Poveda, Rakel; Gschwind, Yves J; Delbaere, Kim; Wieching, Rainer; Wulf, Volker

    2016-01-01

    Falls are common in older adults and can result in serious injuries. Due to demographic changes, falls and related healthcare costs are likely to increase over the next years. Participation and motivation of older adults in fall prevention measures remain a challenge. The iStoppFalls project developed an information and communication technology (ICT)-based system for older adults to use at home in order to reduce common fall risk factors such as impaired balance and muscle weakness. The system aims at increasing older adults' motivation to participate in ICT-based fall prevention measures. This article reports on usability, user-experience and user-acceptance aspects affecting the use of the iStoppFalls system by older adults. In the course of a 16-week international multicenter study, 153 community-dwelling older adults aged 65+ participated in the iStoppFalls randomized controlled trial, of which half used the system in their home to exercise and assess their risk of falling. During the study, 60 participants completed questionnaires regarding the usability, user experience and user acceptance of the iStoppFalls system. Usability was measured with the System Usability Scale (SUS). For user experience the Physical Activity Enjoyment Scale (PACES) was applied. User acceptance was assessed with the Dynamic Acceptance Model for the Re-evaluation of Technologies (DART). To collect more detailed data on usability, user experience and user acceptance, additional qualitative interviews and observations were conducted with participants. Participants evaluated the usability of the system with an overall score of 62 (Standard Deviation, SD 15.58) out of 100, which suggests good usability. Most users enjoyed the iStoppFalls games and assessments, as shown by the overall PACES score of 31 (SD 8.03). With a score of 0.87 (SD 0.26), user acceptance results showed that participants accepted the iStoppFalls system for use in their own home. Interview data suggested that certain

  18. Beyond trial types.

    Science.gov (United States)

    Dyrholm, Mads; Vangkilde, Signe; Bundesen, Claus

    2015-05-01

    Conventional wisdom on psychological experiments has held that when one or more independent variables are manipulated it is essential that all other conditions are kept constant such that confounding factors can be assumed negligible (Woodworth, 1938). In practice, the latter assumption is often questionable because it is generally difficult to guarantee that all other conditions are constant between any two trials. Therefore, the most common way to check for confounding violations of this assumption is to split the experimental conditions in terms of "trial types" to simulate a reduction of unintended trial-by-trial variation. Here, we pose a method which is more general than the use of trial types: use of mathematical models treating measures of potentially confounding factors and manipulated variables as equals on the single-trial level. We show how the method can be applied with models that subsume under the generalized linear item response theory (GLIRT), which is the case for most of the well-known psychometric models (Mellenbergh, 1994). As an example, we provide a new analysis of a single-letter recognition experiment using a nested likelihood ratio test that treats manipulated and measured variables equally (i.e., in exactly the same way) on the single-trial level. The test detects a confounding interaction with time-on-task as a single-trial measure and yields a substantially better estimate of the effect size of the main manipulation compared with an analysis made in terms of trial types.

  19. Americans' Experiences with Marketplace and Medicaid Coverage. Findings from the Commonwealth Fund Affordable Care Act Tracking Survey, March-May 2015.

    Science.gov (United States)

    Collins, Sara R; Rasmussen, Petra W; Doty, Michelle M; Beutel, Sophie

    2015-06-01

    The latest Commonwealth Fund Affordable Care Act Tracking Survey finds the share of uninsured working-age adults was 13 percent in March–May 2015, compared with 20 percent just before the major coverage expansions went into effect. More than half of adults who currently have coverage either through the Affordable Care Act's (ACA's) marketplace plans or Medicaid expansion were uninsured prior to gaining coverage. Of those, more than 60 percent lacked coverage for one year or longer. More than six of 10 adults who used their new plans to obtain care reported they could not have afforded or accessed it previously. Majorities of people with ACA coverage who have used their plans express satisfaction with the doctors covered in their networks and are able to find physicians with relative ease. Wait times to get appointments with physicians in marketplace plans and Medicaid are comparable to those reported by other working-age adults.

  20. Americans' Experiences with ACA Marketplace Coverage: Affordability and Provider Network Satisfaction: Findings from the Commonwealth Fund Affordable Care Act Tracking Survey, February--April 2016.

    Science.gov (United States)

    Gunja, Munira Z; Collins, Sara R; Doty, Michelle M; Beutel, Sophie

    2016-07-01

    For people with low and moderate incomes, the Affordable Care Act's tax credits have made premium costs roughly comparable to those paid by people with job-based health insurance. For those with higher incomes, the tax credits phase out, meaning that adults in marketplace plans on average have higher premium costs than those in employer plans. The law's cost-sharing reductions are reducing deductibles. Lower-income adults in marketplace plans were less likely than higher-income adults to report having deductibles of $1,000 or more. Majorities of new marketplace enrollees and those who have changed plans since they initially obtained marketplace coverage are satisfied with the doctors participating in their plans. Overall, the majority of marketplace enrollees expressed confidence in their ability to afford care if they were to become seriously ill. This issue brief explores these and other findings from the Commonwealth Fund Affordable Care Act Tracking Survey, February--April 2016.

  1. Ⅰ期临床试验过程中受试者的管理体会%Experience of Management about Subjects in Phase Ⅰ Clinical Trials

    Institute of Scientific and Technical Information of China (English)

    梁莉; 焦凯; 李丹; 乔华; 常威; 冯泽岸; 王婷

    2012-01-01

    目的:促进Ⅰ期临床试验过程中受试者的规范化管理.方法:总结我院Ⅰ期临床试验过程中受试者的管理体会,探讨有效的管理模式.结果与结论:通过设立专人管理受试者,在知情同意环节坚持完全告知等原则,选择依从性好的受试者,与其建立相互尊重、理解及合作的关系,为其营造舒适的受试环境等规范受试者的管理,从而提高受试者的依从性,提升临床试验的质量.%OBJECTIVE: To promote standardized management of subjects in phase I clinical trials. METHODS: The experience of the management of subjects in our hospital was summarized to explore the suitable management model. RESULTS & CONCLUSIONS: The management of subjects is standardized, the compliance of subjects is improved and the quality of clinical trail is ensured through designating the specific personnel to go into mutual respecting and understanding partnership with subjects with sound compliance and establish comfortable testing environment, adhering to informed completely of informed consent principle.

  2. Adubação do algodoeiro: XV- ensaios com vários adubos nitrogenados Fertilizer experiments with cotton: XV - trials with various nitrogenous fertilizers

    Directory of Open Access Journals (Sweden)

    Milton G. Fuzatto

    1965-01-01

    Full Text Available Neste artigo são relatados os resultados de 12 ensaios, instalados em vários tipos de solo do Estado de São Paulo, para comparar o efeito de diferentes adubos azotados na cultura algodoeira. Salitre do Chile, nitrato de cal IG e Calnitro IG, aplicados no sulco de plantio juntamente com fósforo e potássio, não diferiram substancialmente. Apenas Urecal IG se mostrou menos eficiente. Aplicados em cobertura aos 30 dias após a germinação, o salitre do Chile, sulfato dc amônio e Nitrocálcio tiveram comportamento semelhante, mas a uréia se mostrou levemente inferior.In this paper are reported the results obtained in twelve experiments comparing various nitrogen sources as mineral fertilizers for cotton. Experiments were conducted for some years, located at different soil types used for cotton in the State of São Paulo. When applying Chilean nitrate, Calnitro IG. nitrato de cal IG and Urecal IG in the furrows together with phosphorus and potassium, the effects obtained were practically the same, except for Urecal IG which showed minor response. With exception of Chilean nitrate, these fertilisers are no more used by farmers presently. In another series of trials Chilean nitrate, ammonium sulphate, Nitrocalcio (ammonium nitrate + calcium carbonate and urea were applied as dressing after 30 days of planting time. These treatments had about the same results; however treatment with urea had a lower effect.

  3. ACT Internet-based vs face-to-face? A randomized controlled trial of two ways to deliver Acceptance and Commitment Therapy for depressive symptoms: an 18-month follow-up.

    Science.gov (United States)

    Lappalainen, Päivi; Granlund, Anna; Siltanen, Sari; Ahonen, Suvi; Vitikainen, Minna; Tolvanen, Asko; Lappalainen, Raimo

    2014-10-01

    The aim of the present study was to investigate two interventions based on Acceptance and Commitment Therapy (ACT) for depressive symptoms: A face-to-face treatment (ACT group) was compared to a guided self-help treatment delivered via the Internet consisting of two assessment sessions (pre and post) and an ACT-based Internet program (iACT). Outpatients experiencing at least mild depressive symptoms were randomized to either approach. The iACT treatment group received access to an ACT-based Internet program and supportive web-based contact over a period of 6 weeks. The face-to-face group received ACT-based treatment once a week over the same period of time. In both groups, the results showed a significant effect on depression symptomatology, and general wellbeing after treatment and at the 18-month follow-up. However, the data indicated that the iACT group changed differently regarding depressive symptoms and wellbeing as compared to the face-to face ACT group. Results showed large pre-treatment to 18-month follow-up within-group effect sizes for all symptom measures in the iACT treatment group (1.59-2.08), and for most outcome measures in the face-to-face ACT group (1.12-1.37). This non-inferiority study provides evidence that guided Internet-delivered ACT intervention can be as effective as ACT-based face-to-face treatment for outpatients reporting depressive symptoms, and it may offer some advantages over a face-to-face intervention. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. Long-acting muscarinic antagonists

    DEFF Research Database (Denmark)

    Busse, William W; Dahl, Ronald; Jenkins, Christine;

    2016-01-01

    -acting anticholinergics as bronchodilators in the treatment of asthma, with results published from clinical trials of glycopyrrolate, umeclidinium and tiotropium. The tiotropium clinical trial programme is the most advanced, with data available from a number of phase II and III studies of tiotropium as an add...... and children with asthma. Tiotropium Respimat has recently been incorporated into the Global Initiative for Asthma 2015 treatment strategy as a recommended alternative therapy at steps 4 and 5 in adult patients with a history of exacerbations. The increasing availability of evidence from ongoing and future...

  5. Construction of a high modulus asphalt (HiMA) trial section Ethekwini: South Africa's first practical experience with design, manufacturing and paving of HiMA

    CSIR Research Space (South Africa)

    Nkgapele, M

    2012-07-01

    Full Text Available A trial section was paved with the recently introduced High Modulus Asphalt (HiMA) technology on South Coast road in eThekwini (Durban). The trial section forms part of an effort to transfer HiMA technology to South Africa, in an initiative aimed...

  6. Americans' Experiences with ACA Marketplace and Medicaid Coverage: Access to Care and Satisfaction: Findings from the Commonwealth Fund Affordable Care Act Tracking Survey, February–April 2016.

    Science.gov (United States)

    Collins, Sara R; Gunja, Munira; Doty, Michelle M; Beutel, Sophie

    2016-05-01

    The fourth wave of the Commonwealth Fund Affordable Care Act Tracking Survey, February--April 2016, finds at the close of the third open enrollment period that the working-age adult uninsured rate stands at 12.7 percent, statistically unchanged from 2015 but significantly lower than 2014 and 2013. Uninsured rates in the past three years have fallen most steeply for low-income adults though remain higher compared to wealthier adults. ACA marketplace and Medicaid coverage is helping to end long bouts without insurance, bridge gaps when employer insurance is lost, and improve access to health care. Sixty-one percent of enrollees who had used their insurance to get care said they would not have been able to afford or access it prior to enrolling. Doctor availability and appointment wait times are similar to those reported by insured Americans overall. Majorities with marketplace or Medicaid coverage continue to be satisfied with their insurance.

  7. The rights of victims according to the criminal procedure act of Republic of Croatia - needs of the victim and practical experience from the perspective of the victim and witness support offices

    Directory of Open Access Journals (Sweden)

    Hamer-Vidmar Nikica

    2016-01-01

    Full Text Available The subject of this paper is to analyze the provisions of the Criminal Procedure Act relating to the general rights of victims and the rights of victims of criminal offenses against sexual freedom and human trafficking. The goal was to determine the relationship between the statutory rights of the victims and their needs, as well as to analyze how the application of these rights affects the victim’s status, a sense of security and protection. Intention was to analyze whether the Act contributes to the prevention of retraumatization and revictimization of victims and if it increases confidence in the judicial system. These effects can be achieved primarily by timely informing victims about their rights, and then by providing those rights in the practice. The analysis made is based on the experience of officials from Victims and Witnesses Support Offices. The purpose of this paper is to promote the implementation of the rights that victims have according the Criminal Procedure Act in order to enable their wellbeing.

  8. Assessing the Impact of Community Engagement Interventions on Health Worker Motivation and Experiences with Clients in Primary Health Facilities in Ghana: A Randomized Cluster Trial.

    Directory of Open Access Journals (Sweden)

    Robert Kaba Alhassan

    Full Text Available Health worker density per 1000 population in Ghana is one of the lowest in the world estimated to be 2.3, below the global average of 9.3. Low health worker motivation induced by poor working conditions partly explain this challenge. Albeit the wage bill for public sector health workers is about 90% of domestic government expenditure on health in countries such as Ghana, staff motivation and performance output remain a challenge, suggesting the need to complement financial incentives with non-financial incentives through a community-based approach. In this study, a systematic community engagement (SCE intervention was implemented to engage community groups in healthcare quality assessment to promote mutual collaboration between clients and healthcare providers, and enhance health worker motivation levels. SCE involves structured use of existing community groups and associations to assess healthcare quality in health facilities. Identified quality gaps are discussed with healthcare providers, improvements made and rewards given to best performing facilities for closing quality care gaps.To evaluate the effect of SCE interventions on health worker motivation and experiences with clients.The study is a cluster randomized trial involving health workers in private (n = 38 and public (n = 26 primary healthcare facilities in two administrative regions in Ghana. Out of 324 clinical and non-clinical staff randomly interviewed at baseline, 234 (72% were successfully followed at end-line and interviewed on workplace motivation factors and personal experiences with clients. Propensity score matching and difference-in-difference estimations were used to estimate treatment effect of the interventions on staff motivation.Intrinsic (non-financial work incentives including cordiality with clients and perceived career prospects appeared to be prime sources of motivation for health staff interviewed in intervention health facilities while financial incentives were

  9. Efficacy of agomelatine and escitalopram on depression, subjective sleep and emotional experiences in patients with major depressive disorder: a 24-wk randomized, controlled, double-blind trial.

    Science.gov (United States)

    Corruble, Emmanuelle; de Bodinat, Christian; Belaïdi, Carole; Goodwin, Guy M

    2013-11-01

    In the present randomized, controlled, double-blind trial (12 wk treatment plus double-blind extension for 12 wk), 25-50 mg/d agomelatine (n = 164) and 10-20 mg/d escitalopram (n = 160) were compared for short- and long-term efficacy, subjective sleep and tolerability. The effects of these drugs on emotional experiences were also compared in patients having completed the Oxford Questionnaire on the Emotional Side-Effects of Antidepressants (agomelatine: n = 25; escitalopram: n = 20). Agomelatine and escitalopram similarly improved depressive symptoms, with clinically relevant score changes over 12 and 24 wk and notable percentage of remitters (week 12: 60.9 and 54.4%; week 24: 69.6 and 63.1% respectively). Over the 12 and 24-wk treatment periods, the 'global satisfaction on sleep' scores increased in both treatment groups and did not differ between groups. Satisfaction with sleep-wake quality was high in both groups; the 'wellness feeling on waking' was more improved with agomelatine than with escitalopram (p = 0.02). In patients with pronounced sleep complaints, quality of sleep and feeling on waking were significantly more improved with agomelatine than with escitalopram (p = 0.016 and p = 0.009, respectively). Emotional blunting was less frequent on agomelatine than on escitalopram. Indeed, 28% of patients on agomelatine vs. 60% on escitalopram felt that their emotions lacked intensity and 16% of patients on agomelatine vs. 53% on escitalopram felt that things that they cared about before illness did not seem important any more (p = 0.024). The tolerability profile of agomelatine was found to be superior to that of escitalopram and the incidence of patients with at least one emergent adverse event leading to treatment discontinuation was lower in the agomelatine group than in the escitalopram group (5.5 vs. 10.6%). The findings suggest that agomelatine displays additional long-term clinical benefits on sleep-wake quality and emotional experiences over

  10. Adubação do milho: VII - Ensaios com torta de algodão Fertilizer experiments with corn: VII - Trials with cottonseed meal

    Directory of Open Access Journals (Sweden)

    G. P. Viégas

    1956-01-01

    Full Text Available No presente estudo são apresentados os resultados obtidos em dez ensaios - três dos quais repetidos, nos mesmos canteiros, por cinco, sete ou oito anos - visando investigar o efeito da torta de algodão empregada isoladamente ou em combinação com cinzas de café e farinha de ossos. Êsses ensaios foram realizados entre 1943-44 e 1951-52 e localizados em sete diferentes estações experimentais do Estado de São Paulo : Campinas, Capão Bonito, Jaú, Pindamonhangaba, Ribeirão Prêto, Santa Rita do Passa-Quatro e Sorocaba. Enquanto a farinha de ossos só aumentou significativamente a produção em Santa Rita, e as cinzas de café, em Santa Rita e Ribeirão Prêto, a torta de algodão provocou aumentos significativos em Santa Rita (dois ensaios, Ribeirão Prêto, Jaú e Campinas Nem sempre a torta deu os resultados esperados, para isso concorrendo, conforme o caso, a elevada fertilidade de algumas terras, o tempo e outros fatores desfavoráveis. Umfator, que em muitos casos contribuiu para diminuir o efeito da torta, foi a redução por ela causada no "stand". Na dose de 500 kg/ha, e completada com outros adubos, onde necessário, a torta de algodão mostrou ser ótima fonte de nutrientes para o milho, mas seu efeito é muito variável quando a aplicação é feita nos sulcos de plantio e no momento em que este é efetuado.In this paper are reported the results obtained in ten fertilizer experiments three of which repeated in the same plots during five, seven or eight seasons - to study the effect, on the corn crop, of cottonseed meal used alone or combined with bone meal or coffee bean ash. These trials were conducted between 1943-44 and 1951-52 and located at seven different agricultural experiment stations of the State of São Paulo. As a whole, the study indicates that, at the rate of about 500 kilograms to the hectare and supplemented where needed with other fertilizers, cottonseed meal is a good source of nutrients for corn, but results

  11. Assessing the Impact of Community Engagement Interventions on Health Worker Motivation and Experiences with Clients in Primary Health Facilities in Ghana: A Randomized Cluster Trial.

    Science.gov (United States)

    Alhassan, Robert Kaba; Nketiah-Amponsah, Edward; Spieker, Nicole; Arhinful, Daniel Kojo; Rinke de Wit, Tobias F

    2016-01-01

    Health worker density per 1000 population in Ghana is one of the lowest in the world estimated to be 2.3, below the global average of 9.3. Low health worker motivation induced by poor working conditions partly explain this challenge. Albeit the wage bill for public sector health workers is about 90% of domestic government expenditure on health in countries such as Ghana, staff motivation and performance output remain a challenge, suggesting the need to complement financial incentives with non-financial incentives through a community-based approach. In this study, a systematic community engagement (SCE) intervention was implemented to engage community groups in healthcare quality assessment to promote mutual collaboration between clients and healthcare providers, and enhance health worker motivation levels. SCE involves structured use of existing community groups and associations to assess healthcare quality in health facilities. Identified quality gaps are discussed with healthcare providers, improvements made and rewards given to best performing facilities for closing quality care gaps. To evaluate the effect of SCE interventions on health worker motivation and experiences with clients. The study is a cluster randomized trial involving health workers in private (n = 38) and public (n = 26) primary healthcare facilities in two administrative regions in Ghana. Out of 324 clinical and non-clinical staff randomly interviewed at baseline, 234 (72%) were successfully followed at end-line and interviewed on workplace motivation factors and personal experiences with clients. Propensity score matching and difference-in-difference estimations were used to estimate treatment effect of the interventions on staff motivation. Intrinsic (non-financial) work incentives including cordiality with clients and perceived career prospects appeared to be prime sources of motivation for health staff interviewed in intervention health facilities while financial incentives were ranked

  12. Adubação da batata-doce em São Paulo parte IV: experiências comparando formas de N, P e K Fertilizer experiments with sweet potatoes IV: trials with some N, P, and K sources

    Directory of Open Access Journals (Sweden)

    A. Paes de Camargo

    1962-01-01

    Full Text Available De 1943-44 a 1945-46 realizaram-se seis experiências (três anuais, uma conduzida por dois e duas por três anos, em três localidades do Estado de São Paulo, para estudar o efeito, sôbre a batata-doce, de diversas formulas contendo sempre 60-100-40 kg/ha de N-P2O5-K2O, mas preparadas com diferentes adubos nitrogenados, fosfatados e potássicos. Em relação ao tratamento sem adubo, foram poucos os casos em que as adubações com NPK aumentaram substancialmente a produção. Nessas condições, superfosfato se mostrou ligeiramente superior à farinha de ossos e não se notou diferença entre cloreto de potássio e cinzas de café. Sulfato de amônio, que figurou na experiênca conduzida por dois anos, e torta de algodão, nas demais, em regra com portaram-se melhor do que salitre do Chile. Individualmente, as fórmulas mais eficientes foram as preparadas com superfosfato, cloreto de potássio e sulfato de amônio ou torta de algodão. Contudo, mesmo com estas, foi muito baixa a freqüência de resultados compensadores.Six experiments with sweet potatoes were located on two soil types of the State of São Paulo to study the effects of fertilizer mixtures prepared with different, N. P, and K sources, but containing always 60-100-40 kilograms of N-P(20(5-K(20 per hectare. The yield increases of fertilized over the unfertilized plots were satisfactory only in a few of the 11 annual results obtained. Under such poor conditions, superphosphate was slightly superior to bone meal and no difference was observed between coffee ashes and potassium chloride. Ammonium sulphate, in one, and cottonseed meal, in the other five trials, as a rule, were more efficient than Chilean nitrate. Individually, the mixtures prepared with superphosphate, potassium chloride, and ammonium sulphate or cottonseed meal gave the best results but even with them the frequency of satisfactory yield increases was very low.

  13. Impact of the University of Colorado's Advanced Clinical Training and Service (ACTS) Program on dental students' clinical experience and cognitive skills, 1994-2006.

    Science.gov (United States)

    Berg, Rob; Call, Richard L; Maguire, Kerry; Berkey, Douglas B; Karshmer, Bernard A; Guyton, Brad; Tawara-Jones, Karen

    2010-04-01

    The University of Colorado Denver School of Dental Medicine has operated a community-based dental education program for all of its students since 1985. A database of student productivity has been maintained in a standardized format, capable of multiyear compilation, since 1994. This study utilizes twelve years of these data to profile the type and amount of clinical treatment that can be provided by a typical fourth-year dental student during a 100-day community-based training experience. Between 1994 and 2006, the school's 423 graduates provided a mean of 922 treatment procedures per student at a mean of 498 patient visits per student. During a typical four-week clinical affiliation, each student provided a mean of approximately twenty-seven restorations on permanent teeth, sixteen restorations on primary teeth, and twenty-four oral surgery procedures (extractions). Students also gained considerable experience in periodontics, fixed and removable prosthodontics, and endodontics. Self-assessed competency ratings tended to increase after completing the program, as did willingness to treat underserved populations after graduation. About 16 percent of graduates reported planning to practice in the public sector after completing dental school. A community-based experience such as this appears to offer an opportunity to substantially augment dental students' clinical training experiences.

  14. Comparing Effectiveness of Active and Passive Client Follow-Up Approaches in Sustaining the Continued Use of Long Acting Reversible Contraceptives (LARC) in Rural Punjab: A Multicentre, Non-Inferiority Trial

    Science.gov (United States)

    Hameed, Waqas; Azmat, Syed Khurram; Ali, Moazzam; Ishaque, Muhammad; Abbas, Ghazunfer; Munroe, Erik; Harrison, Rebecca; Shamsi, Wajahat Hussain; Mustafa, Ghulam; Khan, Omar Farooq; Ali, Safdar; Ahmed, Aftab

    2016-01-01

    Background The use of long-acting reversible contraceptive (LARC) methods is very low in Pakistan with high discontinuation rates mainly attributed to method-related side effects. Mixed evidence is available on the effectiveness of different client follow-up approaches used to ensure method continuation. We compared the effectiveness of active and passive follow-up approaches in sustaining the use of LARC—and within ‘active’ follow-up, we further compared a telephone versus home-based approach in rural Punjab, Pakistan. Methods This was a 12-month multicentre non-inferiority trial conducted in twenty-two (16 rural- and 6 urban-based) franchised reproductive healthcare facilities in district Chakwal of Punjab province, between November 2013 and December 2014. The study comprised of three groups of LARC clients: a) home-based follow-up, b) telephone-based follow-up, and c) passive or needs-based follow-up. Participants in the first two study groups received counselling on scheduled follow-up from the field workers at 1, 3, 6, 9, and 12 month post-insertion whereas participants in the third group were asked to contact the health facility if in need of medical assistance relating to LARC method use. Study participants were recruited with equal allocation to each study group, but participants were not randomized. The analyses are based on 1,246 LARC (intra-uterine contraceptive device and implant) users that completed approximately 12-months of follow-up. The non-inferiority margin was kept at five percentage points for the comparison of active and passive follow-up and six percentage points for telephone and home-based approach. The primary outcome was cumulative probability of method continuation at 12-month among LARC users. Results Women recruited in home-based, telephone-based, and passive groups were 400, 419 and 427, respectively. The cumulative probability of LARC continuation at 12 month was 87.6% (95% CI 83.8 to 90.6) among women who received home

  15. Adubação do milho: VIII - Ensaios com estêrco e adubos minerais Fertilizer experiments with corn: VIII - Trials with farm manure and mineral fertilizers

    Directory of Open Access Journals (Sweden)

    G. P. Viégas

    1956-01-01

    the results of experiments conducted during several years at three different sites of the State of São Paulo: Campinas, on terra roxa misturada soil; Ribeirão Prêto, on terra roxa legítima soil, and Engenheiro Hermilo, on glacial soil. In the Campinas experiment, beside other treatments, manure at the rate of 12.8 metric tons per hectare was compared with a mixture containing 30-90-70 kilograms per hectare of N, P2O5 and K2O respectively as sulfate of ammonia, bone meal (occasionally, superphosphate, and potash chloride, (and also with plots which received half the doses of minerals in addition to half the quantity of manure. The materials used and the rates of application per hectare in Ribeirão Prêto and Engenheiro Hermilo were: 10 metric tons of manure; 80 kilograms of P2O5 in the form of bone meal, and 50 kilograms of K2O as coffee bean ash. The asli supplied also 20 kilograms of P2O5. Each of these materials was used alone or in the possible combinations. At the three locations the manure and minerals were applied annually, before every corn crop. The results obtained in the Campinas experiment with each of the fertilizer treatments were excellent. With small differences, their effect increased in the order: minerals alone, manure alone, 1/2 manure + 1/2 minerals. At Ribeirão Prêto corn gave no response to phosphorus, whereas either manure or coffee bean ash increased considerably the yield. The combination manure-ash was not better than manure alone, showing that the potash content of the later was sufficient for the maximum yield under the conditions of the experiment. Here, manure acted principally as a potash fertilizer. At Engenheiro Hermilo potash did not affect the yield, but bone meal, as well as manure, brought out substantial increases. T increase due to the combination manure-bone meal corresponded to the addition of the increases caused by each material. Under the conditions of this experiment, on soil fairly supplied with organic matter and

  16. Clinical Trials

    Science.gov (United States)

    Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

  17. Real-world experience with interferon-free, direct acting antiviral therapies in Asian Americans with chronic hepatitis C and advanced liver disease

    Science.gov (United States)

    Chang, Christine Y.; Nguyen, Pauline; Le, An; Zhao, Changqing; Ahmed, Aijaz; Daugherty, Tami; Garcia, Gabriel; Lutchman, Glen; Kumari, Radhika; Nguyen, Mindie H.

    2017-01-01

    Abstract Real-life data on interferon (IFN)-free direct acting antiviral (DAA) therapies for chronic hepatitis C (CHC) is limited for Asian Americans. To evaluate sustained virologic response (SVR) and adverse events (AE) in Asian Americans treated with sofosbuvir (SOF)-based, IFN-free DAA therapies. This is a retrospective study of 110 consecutive Asian Americans with HCV genotypes 1 to 3 or 6 treated with IFN-free SOF-based regimens for 8 to 24 weeks between February 2014 and March 2016 at a university center in Northern California. Mean age was 63 ± 12 years, mean BMI was 25 ± 6 (kg/m2), and about half (52%) were male. Most patients were infected with HCV genotype 1 (HCV-1, 64%), followed by HCV-2 (14%), HCV-6 (13%), and HCV-3 (8%). Half had cirrhosis, and the majority of these (67%) had decompensation. Overall SVR12 was 93% (102/110), and highest among patients without cirrhosis, liver transplant, or HCC (100%, 37/37). SVR12 was lower among patients with HCC (82%, 14/17), decompensated cirrhosis (84%, 31/37), or liver transplant (89%, 17/19), regardless of treatment and genotype. Most common AEs were anemia (25%), fatigue (20%), and headache (12%). Anemia was highest in patients receiving SOF/RBV (67%). There was 1 treatment-unrelated serious adverse effect (SAE). There were 7 dose reductions due to anemia or fatigue from RBV and 2 treatment discontinuations due to fatigue or loss of insurance authorization. This real-life cohort of Asian American CHC patients treated with IFN-free SOF-based therapies showed high overall treatment response and good tolerability, despite very high rates of advanced disease and prior treatment failure. PMID:28178174

  18. The Act of Walking

    DEFF Research Database (Denmark)

    Vestergaard, Maria Quvang Harck; Olesen, Mette; Helmer, Pernille Falborg

    2014-01-01

    individuals in Denmark conduct and experience walking, and the ‘rationalities’ (Giddens 1984) that lie behind their choice of mobility. It provides insight into how different lifestyles perceive and act walking in their everyday life. Kaufmann (2002) describes how the individual mobility is influenced......’ of mobility (Jensen 2013:111) such as the urban environment, and the infrastructures. Walking has indeed also a ‘software dimension’ as an embodied performance that trigger the human senses (Jensen 2013) and which is closely related to the habitus and identity of the individual (Halprin 1963). The individual...... by individual strategies, values, perceptions and habits, and how appropriation of mobility is constructed through the internalization of standards and values. The act of walking could thus be understood as the result of dynamic internal negotiation of individual, everyday mobility strategies (Lassen 2005...

  19. A Multicenter, Open-Label Trial to Evaluate the Quality of Life in Adults with ADHD Treated with Long-Acting Methylphenidate (OROS MPH): Concerta Quality of Life (CONQoL) Study

    Science.gov (United States)

    Mattos, Paulo; Rodrigues Louza, Mario; Fernandes Palmini, Andre Luis; de Oliveira, Irismar Reis; Lopes Rocha, Fabio

    2013-01-01

    The available literature provides few studies on the effectiveness of methylphenidate in improving quality of life in individuals with ADHD. Objective: To assess the effectiveness of Methyphenidate OROS formulation (OROS MPH) through QoL in adults with ADHD. Method: A 12-week, multicenter, open-label trial involving 60 patients was used. The…

  20. Continuity and change?: Exploring reactions to a guided self-management intervention in a randomised controlled trial for IBS with reference to prior experience of managing a long term condition

    Science.gov (United States)

    Rogers, Anne; Lee, Victoria; Kennedy, Anne

    2007-01-01

    Self-care interventions are promoted as effective strategies for improving the quality of life and health outcomes for individuals with long-term health conditions. Outcome measures used in evaluations using Randomised Controlled Trials (RCTs) are not designed to consider patients' prior management strategies and experience of illness. Yet the experience of illness literature suggests that adjusting to living with chronic illness, together with broader contextual influences, are likely to be relevant to understanding responses to self-management initiatives. Using group and individual interview data we attempt to illuminate the transposition of IBS from a condition unsatisfactorily managed by medicine to one successfully managed within the life worlds of individuals. If routine embedding of complex interventions depends on the accomplishment of integration and workability in patients' everyday lives then the design and evaluation of such interventions should view participation as part of a process of continuity as well as change. Responses to formal self-management can be extended beyond psychological and other quantitatively measured outcomes. A useful addendum to trial outcomes for self-management education is an understanding of change as being inextricably linked to people's previous attempts to, and experience of, managing long-term conditions. We suggest that the benefits of understanding the prior experience of managing illness and contact with health services include the acceptability and workability of complex interventions in patients' everyday lives. PMID:17316438

  1. Fundamentals of clinical trials

    CERN Document Server

    Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

    2015-01-01

    This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

  2. Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials.

    Science.gov (United States)

    Meropol, Neal J; Wong, Yu-Ning; Albrecht, Terrance; Manne, Sharon; Miller, Suzanne M; Flamm, Anne Lederman; Benson, Al Bowen; Buzaglo, Joanne; Collins, Michael; Egleston, Brian; Fleisher, Linda; Katz, Michael; Kinzy, Tyler G; Liu, Tasnuva M; Margevicius, Seunghee; Miller, Dawn M; Poole, David; Roach, Nancy; Ross, Eric; Schluchter, Mark D

    2016-02-10

    Lack of knowledge and negative attitudes have been identified as barriers to participation in clinical trials by patients with cancer. We developed Preparatory Education About Clinical Trials (PRE-ACT), a theory-guided, Web-based, interactive computer program, to deliver tailored video educational content to patients in an effort to overcome barriers to considering clinical trials as a treatment option. A prospective, randomized clinical trial compared PRE-ACT with a control condition that provided general clinical trials information produced by the National Cancer Institute (NCI) in text format. One thousand two hundred fifty-five patients with cancer were randomly allocated before their initial visit with an oncologist to PRE-ACT (n = 623) or control (n = 632). PRE-ACT had three main components: assessment of clinical trials knowledge and attitudinal barriers, values assessment with clarification back to patients, and provision of a video library tailored to address each patient's barriers. Outcomes included knowledge and attitudes and preparation for decision making about clinical trials. Both PRE-ACT and control interventions improved knowledge and attitudes (all P < .001) compared with baseline. Patients randomly allocated to PRE-ACT showed a significantly greater increase in knowledge (P < .001) and a significantly greater decrease in attitudinal barriers (P < .001) than did their control (text-only) counterparts. Participants in both arms significantly increased their preparedness to consider clinical trials (P < .001), and there was a trend favoring the PRE-ACT group (P < .09). PRE-ACT was also associated with greater patient satisfaction than was NCI text alone. These data show that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials. Both text and tailored video were effective. The PRE-ACT interactive video program was more effective than NCI text in improving

  3. Teaching Speech Acts

    Directory of Open Access Journals (Sweden)

    Teaching Speech Acts

    2007-01-01

    Full Text Available In this paper I argue that pragmatic ability must become part of what we teach in the classroom if we are to realize the goals of communicative competence for our students. I review the research on pragmatics, especially those articles that point to the effectiveness of teaching pragmatics in an explicit manner, and those that posit methods for teaching. I also note two areas of scholarship that address classroom needs—the use of authentic data and appropriate assessment tools. The essay concludes with a summary of my own experience teaching speech acts in an advanced-level Portuguese class.

  4. Combinations of long acting β2 agonists to tiotropium: A randomized, double-blind, placebo-controlled, active-drug controlled, parallel design academic clinical trial in moderate COPD male patients

    Directory of Open Access Journals (Sweden)

    Mohammed Imran

    2015-01-01

    Conclusions: Study shows that tiotropium alone once a day is the evidence based and rationale pharmacotherapy in moderate COPD. There is no advantage or statistical significance of adding long acting β2 agonists (LABA such as formoterol to tiotropium either for 12 h (once daily or 24 h (twice daily.

  5. La socialisation universitaire des étudiants The University Socialization of Students. A School Experiment Placing on Trial the Learning Project and Future projects

    Directory of Open Access Journals (Sweden)

    Aziz Jellab

    2011-12-01

    Full Text Available Trois dimensions en tension caractérisent l’expérience étudiante : la socialisation aux normes et à la vie universitaires, la construction du projet d’apprendre et l’élaboration d’un projet professionnel (ou de projets d’avenir. A partir d’une recherche qualitative, menée auprès d’étudiants de L1, inscrits pour les uns dans une filière de masse (Psychologie, pour les autres, dans une filière à effectif plus réduit (Sociologie-Histoire et Langues étrangères appliquées, cet article vise à mettre en évidence les différentes épreuves qui participent de l’affiliation aux études universitaires. En enrichissant ce matériau par d’autres entretiens menés avec des étudiants de Master 1, nous observons que le passage de l’enseignement secondaire vers l’enseignement supérieur désigne un processus dans lequel le “choix” de l’université oblige à la construction d’un nouveau rapport aux études, un rapport laissant apparaître les effets des spécificités disciplinaires. Le projet d’apprendre et les manières de s’approprier des savoirs accompagnent un processus de subjectivation qu’il s’agit de concilier avec la sociabilité étudiante, sans négliger les projets d’avenir. C’est dans les interstices de ces tensions que réside le risque d’un échec scolaire, surtout que l’université reste faiblement contraignante, comme en témoigne l’évocation récurrente par les étudiants de la catégorie de “liberté”.Three dimensions in tension characterize the female students’ experience: socialization to the standards and university life, the construction of a learning project and the development of a professional project (or future projects. Starting from qualitative research, undertaken among students of the L1, for some enroled in a mass discipline (Psychology, and for others, in a more reduced, more elective field (Sociology-History and applied Foreign languages, this article aims

  6. A digital network for long-distance echocardiographic image and data transmission in clinical trials: the CEDIM (Carnitina, Ecocardiografia Digitalizzata, Infarto Miocardico) study experience.

    Science.gov (United States)

    Iliceto, S; D'Ambrosio, G; Scrutinio, D; Marangelli, V; Boni, L; Rizzon, P

    1993-01-01

    A special computer network has been specifically designed and realized to connect 36 Italian cardiological institutions to a central core laboratory. This network, which has been created to run the CEDIM Multicenter Trial (effects of L-carnitine on left ventricular function in patients with myocardial infarction assessed by digital echocardiography), enables automatic verification, via computer, 24 hours a day, of patient eligibility criteria, randomization, transmission, and filing of real-time left ventricular echocardiographic examinations. All the investigators participating in the CEDIM trial underwent several training courses as well as dummy run procedures to achieve optimal performance of all the operational procedures required for the network to function smoothly and correctly. This paper describes the aims of this special network, its technical characteristics, and the investigator training and dummy run procedures.

  7. Long-term prognosis in an ST-segment elevation myocardial infarction population treated with routine primary percutaneous coronary intervention: from clinical trial to real-life experience

    DEFF Research Database (Denmark)

    Pedersen, Sune; Galatius, Soren; Mogelvang, Rasmus;

    2009-01-01

    BACKGROUND: We sought to describe the long-term prognosis after routine primary percutaneous coronary intervention (pPCI) in a contemporary consecutive population of patients with presumed ST-segment elevation myocardial infarction, compare it with similar results from the landmark DANAMI-2 trial...... trial reached the combined end point of death, reinfarction, or stroke (P=0.68), whereas the all-cause mortality was 13.0% and 13.7%, respectively (P=0.65). Patients admitted during off hours had the same risk of reaching the combined end point of death, reinfarction, or stroke compared with patients......). Furthermore, the long-term prognosis was the same regardless of whether the pPCI was performed during off hours or office hours. Thus, pPCI including transportation of patients from noninvasive centers can be applied successfully in a real-life population....

  8. Reward and punishment act as distinct factors in guiding behavior.

    Science.gov (United States)

    Kubanek, Jan; Snyder, Lawrence H; Abrams, Richard A

    2015-06-01

    Behavior rests on the experience of reinforcement and punishment. It has been unclear whether reinforcement and punishment act as oppositely valenced components of a single behavioral factor, or whether these two kinds of outcomes play fundamentally distinct behavioral roles. To this end, we varied the magnitude of a reward or a penalty experienced following a choice using monetary tokens. The outcome of each trial was independent of the outcome of the previous trial, which enabled us to isolate and study the effect on behavior of each outcome magnitude in single trials. We found that a reward led to a repetition of the previous choice, whereas a penalty led to an avoidance of the previous choice. Surprisingly, the effects of the reward magnitude and the penalty magnitude revealed a pronounced asymmetry. The choice repetition effect of a reward scaled with the magnitude of the reward. In a marked contrast, the avoidance effect of a penalty was flat, not influenced by the magnitude of the penalty. These effects were mechanistically described using a reinforcement learning model after the model was updated to account for the penalty-based asymmetry. The asymmetry in the effects of the reward magnitude and the punishment magnitude was so striking that it is difficult to conceive that one factor is just a weighted or transformed form of the other factor. Instead, the data suggest that rewards and penalties are fundamentally distinct factors in governing behavior.

  9. Comparing the effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT intervention with a wait list control on health related quality of life among adults with multimorbidity: Study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Brian Slattery

    2015-10-01

    Full Text Available Multimorbidity is defined as the coexistence of two or more conditions within one person, where no one condition is primary. Chronic Pain (CP is found to be one of the most frequent conditions represented amongst multimorbidities. CP and in particular MM, can have significant debilitating effects on a persons’ Health Related Quality of Life (HRQoL. There is a dearth of research however, targeting and improving HRQoL for people living with MM, were CP is a feature. Aim of Investigation: This study will compare the clinical- effectiveness of an online ACT intervention with a waitlist control condition in terms of increasing health related quality of life among people with multimorbidities, were chronic pain is a feature. Methods: Adult participants with non-malignant pain that persists for at least three months and at least one other condition as diagnosed by a doctor will be randomised to one of two study conditions. The experimental group will undergo an 8-session internet-delivered ACT-programme over an 8-week period. A wait-list group will be offered the ACT intervention after the 3-month follow-up period. Results: Participants will be assessed pre-intervention, post-intervention and at a 3-month follow-up. HRQoL will be the primary outcome. Secondary outcomes will include: pain intensity; depression; acceptance of chronic pain and symptoms of other morbidities. Conclusions: At present, we are in the early stages of participant recruitment. As a result, the focus of this poster will be on describing the methodological and recruitment processes for the current study.

  10. Experience With Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study.

    Science.gov (United States)

    Krischer, Jeffrey; Cronholm, Peter F; Burroughs, Cristina; McAlear, Carol A; Borchin, Renee; Easley, Ebony; Davis, Trocon; Kullman, Joyce; Carette, Simon; Khalidi, Nader; Koening, Curry; Langford, Carol A; Monach, Paul; Moreland, Larry; Pagnoux, Christian; Specks, Ulrich; Sreih, Antoine G; Ytterberg, Steven; Merkel, Peter A

    2017-02-28

    The target sample size for clinical trials often necessitates a multicenter (center of excellence, CoE) approach with associated added complexity, cost, and regulatory requirements. Alternative recruitment strategies need to be tested against this standard model. The aim of our study was to test whether a Web-based direct recruitment approach (patient-centric, PC) using social marketing strategies provides a viable option to the CoE recruitment method. PC recruitment and Web-based informed consent was compared with CoE recruitment for a randomized controlled trial (RCT) of continuing versus stopping low-dose prednisone for maintenance of remission of patients with granulomatosis with polyangiitis (GPA). The PC approach was not as successful as the CoE approach. Enrollment of those confirmed eligible by their physician was 10 of 13 (77%) and 49 of 51 (96%) in the PC and CoE arms, respectively (P=.05). The two approaches were not significantly different in terms of eligibility with 34% of potential participants in the CoE found to be ineligible as compared with 22% in the PC arm (P=.11) nor in provider acceptance, 22% versus 26% (P=.78). There was no difference in the understanding of the trial as reflected in the knowledge surveys of individuals in the PC and CoE arms. PC recruitment was substantially less successful than that achieved by the CoE approach. However, the PC approach was good at confirming eligibility and was as acceptable to providers and as understandable to patients as the CoE approach. The PC approach should be evaluated in other clinical settings to get a better sense of its potential.

  11. Experience With Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study

    Science.gov (United States)

    2017-01-01

    Background The target sample size for clinical trials often necessitates a multicenter (center of excellence, CoE) approach with associated added complexity, cost, and regulatory requirements. Alternative recruitment strategies need to be tested against this standard model. Objectives The aim of our study was to test whether a Web-based direct recruitment approach (patient-centric, PC) using social marketing strategies provides a viable option to the CoE recruitment method. Methods PC recruitment and Web-based informed consent was compared with CoE recruitment for a randomized controlled trial (RCT) of continuing versus stopping low-dose prednisone for maintenance of remission of patients with granulomatosis with polyangiitis (GPA). Results The PC approach was not as successful as the CoE approach. Enrollment of those confirmed eligible by their physician was 10 of 13 (77%) and 49 of 51 (96%) in the PC and CoE arms, respectively (P=.05). The two approaches were not significantly different in terms of eligibility with 34% of potential participants in the CoE found to be ineligible as compared with 22% in the PC arm (P=.11) nor in provider acceptance, 22% versus 26% (P=.78). There was no difference in the understanding of the trial as reflected in the knowledge surveys of individuals in the PC and CoE arms. Conclusions PC recruitment was substantially less successful than that achieved by the CoE approach. However, the PC approach was good at confirming eligibility and was as acceptable to providers and as understandable to patients as the CoE approach. The PC approach should be evaluated in other clinical settings to get a better sense of its potential. PMID:28246067

  12. Patient participation in postoperative care activities in patients undergoing total knee replacement surgery: Multimedia Intervention for Managing patient Experience (MIME). Study protocol for a cluster randomised crossover trial.

    Science.gov (United States)

    McDonall, Jo; de Steiger, Richard; Reynolds, John; Redley, Bernice; Livingston, Patricia; Botti, Mari

    2016-07-18

    Patient participation is an important indicator of quality care. Currently, there is little evidence to support the belief that participation in care is possible for patients during the acute postoperative period. Previous work indicates that there is very little opportunity for patients to participate in care in the acute context. Patients require both capability, in terms of having the required knowledge and understanding of how they can be involved in their care, and the opportunity, facilitated by clinicians, to engage in their acute postoperative care. This cluster randomised crossover trial aims to test whether a multimedia intervention improves patient participation in the acute postoperative context, as determined by pain intensity and recovery outcomes. A total of 240 patients admitted for primary total knee replacement surgery will be invited to participate in a cluster randomised, crossover trial and concurrent process evaluation in at least two wards at a major non-profit private hospital in Melbourne, Australia. Patients admitted to the intervention ward will receive the multimedia intervention daily from Day 1 to Day 5 (or day of discharge, if prior). The intervention will be delivered by nurses via an iPad™, comprising information on the goals of care for each day following surgery. Patients admitted to the control ward will receive usual care as determined by care pathways currently in use across the organization. The primary endpoint is the "worst pain experienced in the past 24 h" on Day 3 following TKR surgery. Pain intensity will be measured using the numerical rating scale. Secondary outcomes are interference of pain on activities of daily living, length of stay in hospital, function and pain following TKR surgery, overall satisfaction with hospitalisation, postoperative complications and hospital readmission. The results of this study will contribute to our understanding of the effectiveness of interventions that provide knowledge and

  13. CLinical experience acquired with the efalizumab (Raptiva) (CLEAR) trial in patients with moderate-to-severe plaque psoriasis: results from a phase III international randomized, placebo-controlled trial.

    Science.gov (United States)

    Dubertret, L; Sterry, W; Bos, J D; Chimenti, S; Shumack, S; Larsen, C G; Shear, N H; Papp, K A

    2006-07-01

    Efalizumab (anti-CD11a), a humanized monoclonal antibody, blocks multiple T-cell-dependent functions implicated in the pathogenesis of psoriasis, including T-cell activation, migration to the skin, reactivation in psoriatic skin and interactions with keratinocytes. This multinational, randomized, double-blind, placebo-controlled, parallel-group trial was designed to evaluate the safety and efficacy of subcutaneous efalizumab 1.0 mg kg-1 once weekly for 12 weeks compared with placebo in a population that included high-need patients, defined as those for whom at least two systemic therapies were unsuitable because of lack of efficacy, intolerance or contraindication. Patients with moderate-to-severe plaque psoriasis [involvement of >or=10% of total body surface area and Psoriasis Area and Severity Index (PASI)>or=12.0 at screening] were randomized in a 2:1 ratio to receive efalizumab or placebo. The primary efficacy endpoint was the proportion of patients achieving >or=75% PASI improvement (PASI-75 response) at week 12 in the intention-to-treat population; secondary endpoints included changes in PASI, static Physician's Global Assessment, Physician's Global Assessment of change from baseline and percentage of body surface area affected. Results We enrolled 793 patients (529 received efalizumab and 264 placebo), including 526 high-need patients (342 received efalizumab and 184 placebo). Week 12 PASI-75 rates were 29.5% for efalizumab compared with 2.7% for placebo among high-need patients (Pgeneral moderate-to-severe psoriasis patient population. In view of its demonstrated efficacy and safety profile, efalizumab represents a valuable option for the treatment of adult patients with moderate-to-severe plaque psoriasis, including high-need patients.

  14. Establishing the effectiveness, cost-effectiveness and student experience of a Simulation-based education Training program On the Prevention of Falls (STOP-Falls) among hospitalised inpatients: a protocol for a randomised controlled trial.

    Science.gov (United States)

    Williams, Cylie; Bowles, Kelly-Ann; Kiegaldie, Debra; Maloney, Stephen; Nestel, Debra; Kaplonyi, Jessica; Haines, Terry

    2016-06-02

    Simulation-based education (SBE) is now commonly used across health professional disciplines to teach a range of skills. The evidence base supporting the effectiveness of this approach for improving patient health outcomes is relatively narrow, focused mainly on the development of procedural skills. However, there are other simulation approaches used to support non-procedure specific skills that are in need of further investigation. This cluster, cross-over randomised controlled trial with a concurrent economic evaluation (cost per fall prevented) trial will evaluate the effectiveness, cost-effectiveness and student experience of health professional students undertaking simulation training for the prevention of falls among hospitalised inpatients. This research will target the students within the established undergraduate student placements of Monash University medicine, nursing and allied health across Peninsula Health acute and subacute inpatient wards. The intervention will train the students in how to provide the Safe Recovery program, the only single intervention approach demonstrated to reduce falls in hospitals. This will involve redevelopment of the Safe Recovery program into a one-to-many participant SBE program, so that groups of students learn the communication skills and falls prevention knowledge necessary for delivery of the program. The primary outcome of this research will be patient falls across participating inpatient wards, with secondary outcomes including student satisfaction with the SBE and knowledge gain, ward-level practice change and cost of acute/rehabilitation care for each patient measured using clinical costing data. The Human Research Ethics Committees of Peninsula Health (LRR/15/PH/11) and Monash University (CF15/3523-2015001384) have approved this research. The participant information and consent forms provide information on privacy, storage of results and dissemination. Registration of this trial has been completed with the

  15. Stroke Trials Registry

    Science.gov (United States)

    ... News About Neurology Image Library Search The Internet Stroke Center Trials Registry Clinical Trials Interventions Conditions Sponsors ... a clinical trial near you Welcome to the Stroke Trials Registry Our registry of clinical trials in ...

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Z > Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks and Benefits ... of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study ...

  17. Lessons and implications from a mass immunization campaign in squatter settlements of Karachi, Pakistan: an experience from a cluster-randomized double-blinded vaccine trial [NCT00125047

    Directory of Open Access Journals (Sweden)

    Abu-Elyazeed Remon

    2006-05-01

    Full Text Available Abstract Objective To determine the safety and logistic feasibility of a mass immunization strategy outside the local immunization program in the pediatric population of urban squatter settlements in Karachi, Pakistan. Methods A cluster-randomized double blind preventive trial was launched in August 2003 in 60 geographic clusters covering 21,059 children ages 2 to 16 years. After consent was obtained from parents or guardians, eligible children were immunized parenterally at vaccination posts in each cluster with Vi polysaccharide or hepatitis A vaccine. Safety, logistics, and standards were monitored and documented. Results The vaccine coverage of the population was 74% and was higher in those under age 10 years. No life-threatening serious adverse events were reported. Adverse events occurred in less than 1% of all vaccine recipients and the main reactions reported were fever and local pain. The proportion of adverse events in Vi polysaccharide and hepatitis A recipients will not be known until the end of the trial when the code is broken. Throughout the vaccination campaign safe injection practices were maintained and the cold chain was not interrupted. Mass vaccination in slums had good acceptance. Because populations in such areas are highly mobile, settlement conditions could affect coverage. Systemic reactions were uncommon and local reactions were mild and transient. Close community involvement was pivotal for information dissemination and immunization coverage. Conclusion This vaccine strategy described together with other information that will soon be available in the area (cost/effectiveness, vaccine delivery costs, etc will make typhoid fever control become a reality in the near future.

  18. [The use of caspofungin in extremely low birth weight preterm infants based on clinical trials and reports considering the own experience (case report)].

    Science.gov (United States)

    Stempniewicz, Krzysztof; Walas, Wojciech; Gregorek-Pełka, Edyta; Kamińska, Ewa

    2014-01-01

    In recent years, despite of significant progress in the treatment of premature infants with extremely low body weight, still a significant problem remains severe, treatment-resistant generalized infections among which the percentage of fungal infections is increasing. The invasive candidiasis, especially caused by non-albicans species of Candida, are of particular importance. In the case of resistance on fluconazole and amphotericin B the use of echinocandin drug may be a useful choice. This paper reviews the pharmacokinetics of caspofungin in neonates and children, as well as the case reports and clinical trials on the use of caspofungin in neonates, including the premature infants. We describe also the premature neonate with low birth weight and a generalized infection caused by Candida glabrata, where, despite of the treatment based on the sensitivity of the fungus it did not achieve clinical improvement and sterilization of cultures. It was not until the lead-in of caspofungin in dose 2 mg/kg/day allowed to cure the patient. There was a transient increase in the activity of aminotransferases and level of bilirubin as a complication of treatment. At the end of application of caspofungin the liver functions have been slowly normalized. Caspofungin appeared to be effective in the treatment of systemic fungal C. glabrata in premature neonate with extremely low birth weight. Echinocandins, including caspofungin, appear to be a promising alternative to previously used agents in the treatment of invasive Candida infections in newborns. However, the further randomized trials on the use of caspofungin in preterm neonates, regarding long term follow-up, should be undertaken.

  19. Lessons and implications from a mass immunization campaign in squatter settlements of Karachi, Pakistan: an experience from a cluster-randomized double-blinded vaccine trial [NCT00125047

    Science.gov (United States)

    Khan, Mohammad Imran; Ochiai, Rion Leon; Hamza, Hasan Bin; Sahito, Shah Muhammad; Habib, Muhammad Atif; Soofi, Sajid Bashir; Bhutto, Naveed Sarwar; Rasool, Shahid; Puri, Mahesh K; Ali, Mohammad; Wasan, Shafi Mohammad; Khan, Mohammad Jawed; Abu-Elyazeed, Remon; Ivanoff, Bernard; Galindo, Claudia M; Pang, Tikki; Donner, Allan; von Seidlein, Lorenz; Acosta, Camilo J; Clemens, John D; Nizami, Shaikh Qamaruddin; Bhutta, Zulfiqar A

    2006-01-01

    Objective To determine the safety and logistic feasibility of a mass immunization strategy outside the local immunization program in the pediatric population of urban squatter settlements in Karachi, Pakistan. Methods A cluster-randomized double blind preventive trial was launched in August 2003 in 60 geographic clusters covering 21,059 children ages 2 to 16 years. After consent was obtained from parents or guardians, eligible children were immunized parenterally at vaccination posts in each cluster with Vi polysaccharide or hepatitis A vaccine. Safety, logistics, and standards were monitored and documented. Results The vaccine coverage of the population was 74% and was higher in those under age 10 years. No life-threatening serious adverse events were reported. Adverse events occurred in less than 1% of all vaccine recipients and the main reactions reported were fever and local pain. The proportion of adverse events in Vi polysaccharide and hepatitis A recipients will not be known until the end of the trial when the code is broken. Throughout the vaccination campaign safe injection practices were maintained and the cold chain was not interrupted. Mass vaccination in slums had good acceptance. Because populations in such areas are highly mobile, settlement conditions could affect coverage. Systemic reactions were uncommon and local reactions were mild and transient. Close community involvement was pivotal for information dissemination and immunization coverage. Conclusion This vaccine strategy described together with other information that will soon be available in the area (cost/effectiveness, vaccine delivery costs, etc) will make typhoid fever control become a reality in the near future. PMID:16725026

  20. Experiences of Parents with the Reading to Learn Approach: A Randomised Control Trial Initiative to Improve Literacy and Numeracy in Kenya and Uganda

    Science.gov (United States)

    Abuya, Benta A.; Oketch, Moses; Ngware, Moses W.; Mutisya, Maurice; Musyoka, Peter K.

    2015-01-01

    Parental involvement in their children's schooling is in recognition that establishing the context in which a child attends school is important. Reading to Learn (RtL)was implemented in two districts of Kwale and Kinango in Kenya and of Amolatar and Dokolo in Uganda. This paper looks at parental involvement and their experiences with RtL. Data are…

  1. Treatment for myeloid leukaemia of Down syndrome: population-based experience in the UK and results from the Medical Research Council AML 10 and AML 12 trials.

    NARCIS (Netherlands)

    Rao, A.; Hills, R.K.; Stiller, C.; Gibson, B.E.; Graaf, S.S.N. de; Hann, I.M.; O'Marcaigh, A.; Wheatley, K.; Webb, D.K.

    2006-01-01

    Down syndrome (DS) children are at an increased risk of developing myelodysplasia and acute myeloid leukaemia (AML). We retrospectively analysed the population-based data on 81 children with myeloid leukaemia of Down syndrome (ML-DS) from the UK National Registry of Childhood Tumours and experience

  2. 'Mind the Gap'-The Impact of Variations in the Duration of the Treatment Gap and Overall Treatment Time in the First UK Anal Cancer Trial (ACT I)

    Energy Technology Data Exchange (ETDEWEB)

    Glynne-Jones, Rob, E-mail: rob.glynnejones@nhs.net [Mount Vernon Centre for Cancer Treatment, Northwood (United Kingdom); Sebag-Montefiore, David [St James' s Institute of Oncology, St James' s University Hospital, Leeds (United Kingdom); Adams, Richard [Cardiff University and Velindre Cancer Centre, Cardiff (United Kingdom); McDonald, Alec [Beatson West of Scotland Cancer Centre, Glasgow (United Kingdom); Gollins, Simon [North Wales Cancer Treatment Centre, Rhyl (United Kingdom); James, Roger [Kent Oncology Centre, Maidstone General Hospital, Maidstone (United Kingdom); Northover, John M.A. [Imperial Cancer Research Fund Colorectal Cancer Unit, St Mark' s Hospital, Harrow (United Kingdom); Meadows, Helen M.; Jitlal, Mark [Cancer Research UK and University College London Cancer Trials Centre, London (United Kingdom)

    2011-12-01

    Purpose: The United Kingdom Coordinating Committee on Cancer Research anal cancer trial demonstrated the benefit of combined modality treatment (CMT) using radiotherapy (RT), infusional 5-fluorouracil, and mitomycin C over RT alone. The present study retrospectively examines the impact of the recommended 6-week treatment gap and local RT boost on long-term outcome. Methods and Materials: A total of 577 patients were randomly assigned RT alone or CMT. After a 6-week gap responders received a boost using either additional external beam radiotherapy (EBRT) (15 Gy) or iridium-192 implant (25 Gy). The effect of boost, the gap between initial treatment (RT alone or CMT) and boost (Tgap), and overall treatment time (OTT) were examined for their impact on outcome. Results: Among the 490 good responders, 436 (89%) patients received a boost after initial treatment. For boosted patients, the risk of anal cancer death decreased by 38% (hazard ratio [HR]: 0.62, 99% CI 0.35-1.12; p = 0.04), but there was no evidence this was mediated via a reduction in locoregional failure (LRF) (HR: 0.90, 99% CI 0.48-1.68; p = 0.66). The difference in Tgap was only 1.4 days longer for EBRT boost, compared with implant (p = 0.51). OTT was longer by 6.1 days for EBRT (p = 0.006). Tgap and OTT were not associated with LRF. Radionecrosis was reported in 8% of boosted, compared with 0% in unboosted patients (p = 0.03). Conclusions: These results question the benefit of a radiotherapy boost after a 6-week gap. The higher doses of a boost may contribute more to an increased risk of late morbidity, rather than local control.

  3. Mortality and morbidity during one year of follow-up in suspected acute myocardial infarction in relation to early diagnosis: experiences from the MIAMI trial.

    Science.gov (United States)

    Herlitz, J; Karlson, B W; Hjalmarson, A

    1990-08-01

    From a large randomized multicentre trial of metoprolol in suspected acute myocardial infarction (n = 5778) we report on the outcome during 1 year of follow-up, in relation to early diagnosis. Patients who developed a confirmed infarction had a 1-year mortality rate of 12.8%. This was significantly higher than the mortality rate of 6.3% (P less than 0.001) in patients with possible infarction and it was also higher than that in patients with no infarction, which was 5.0% (P less than 0.001). A multivariate analysis showed that independent risk predictors in the clinical history of patients without confirmed infarction were a history of angina pectoris, chronic use of digitalis and advanced age. After 1 year, angina pectoris was most common in patients with an initial possible infarction. These patients were also in most urgent need of bypass surgery. We thus conclude that the mortality during 1 year of follow-up among patients with an initially strongly suspected acute myocardial infarction was clearly related to whether or not the patient developed a myocardial infarction.

  4. Prognosis during one year for patients with myocardial infarction in relation to the development of Q waves: experiences from the Miami trial.

    Science.gov (United States)

    Herlitz, J; Hjalmarson, A; Karlson, B W

    1990-04-01

    From a randomized multicenter trial with metoprolol in suspected acute myocardial infarction (n = 5778) we report on the outcome during a one-year follow-up in patients with confirmed infarction (n = 4106) in relation to whether or not they developed Q waves. Patients with Q waves had another pattern of risk factors, including lower age and a lower occurrence of previous infarction, angina pectoris, and congestive heart failure. After one year follow-up, 14.3% of the patients with Q waves had died versus 9.0% of those without Q waves (p less than 0.001). Reinfarction during the first year occurred in 8.2% of patients with Q waves and 12.5% of patients without Q waves (p less than 0.001). After one year, other morbidity aspects appeared relatively independent of the original presence of Q waves. In conclusion, during the first year after development of acute myocardial infarction the appearance of Q waves during the first three days is associated with a higher mortality and a lower reinfarction rate, whereas other morbidity aspects appear to be relatively independent of its presence.

  5. Experiences and Perceptions of Problem Gamblers on Cognitive and Exposure Therapies When Taking Part in a Randomised Controlled Trial: A Qualitative Study.

    Science.gov (United States)

    Smith, David; Pols, Rene; Lavis, Tiffany; Battersby, Malcolm; Harvey, Peter

    2016-12-01

    In South Australia (SA) problem gambling is mainly a result of the widespread availability of electronic gaming machines. A key treatment provider in SA offers free cognitive and behavioural therapy (CBT) to help-seeking problem gamblers. The CBT program focuses on the treatment of clients' urge to gamble using exposure therapy (ET) and cognitive therapy (CT) to restructure erroneous gambling beliefs. The aim of this study was to explore treatment specific and non-specific effects for CT alone and ET alone using qualitative interviews. Interviewees were a sub-sample of participants from a randomised trial that investigated the relative efficacy of CT versus ET. Findings revealed that all interviewees gained benefit from their respective therapies and their comments did not appear to favour one therapy over another. Both treatment specific and treatment non-specific effects were well supported as playing a therapeutic role to recovery. Participants' comments in both therapy groups suggested that symptom reduction was experienced on a gambling related urge-cognition continuum. In addition to symptom improvement from therapy-specific mechanisms, ET participants described a general acquisition of "rational thought" from their program of therapy and CT participants had "taken-over" their gambling urges. The findings also highlighted areas for further improvement including therapy drop-out.

  6. A prospective, randomized, multicentre trial for the treatment of refractory status epilepticus; experiences from evaluating the effect of the novel drug candidate, NS1209.

    Science.gov (United States)

    Sabers, Anne; Wolf, Peter; Møller, Arne; Rysgaard, Karen; Ben-Menachem, Elinor

    2013-09-01

    Refractory status epilepticus (RSE) is a life-threatening condition that requires immediate and aggressive treatment. Unfortunately, sometimes standard antiepileptic treatment is insufficient. Furthermore, alternative therapeutic options are limited by low evidence of efficacy. The primary objective of this study was to evaluate the effects of the novel drug candidate, NS1209 versus third-line standard treatment (phenytoin/valproate) for RSE. Having not reached the study end-points, the purpose of this paper is to discuss the challenges that are encountered in conducting a controlled study of RSE. This was a phase II, prospective, multicentre, single-blinded, randomized clinical trial and included patients to two separate protocols for convulsive and non-convulsive RSE (NS1209-006 and NS1209-007). In total, 28 patients were included and 14 patients were exposed to NS1209. At study conclusion, the study was insufficiently powered to detect any statistically significant difference between the two treatment groups. This was especially true for the convulsive RSE protocol. We conclude that high-quality studies in RSE are difficult to conduct owing to a number of ethical and practical problems associated with this critical illness. Challenges for further studies are discussed.

  7. Autism: Why Act Early?

    Science.gov (United States)

    ... What's this? Submit Button Past Emails CDC Features Autism: Why Act Early? Language: English Español (Spanish) Recommend ... helped the world make sense." Florida teenager with Autism Spectrum Disorder "Because my parents acted early, I ...

  8. Legislation for trial registration and data transparency

    Directory of Open Access Journals (Sweden)

    Wu Tai-Xiang

    2010-05-01

    Full Text Available Abstract Public confidence in clinical trials has been eroded by data suppression, misrepresentation and manipulation. Although various attempts have been made to achieve universal trial registration- e.g., Declaration of Helsinki, WHO clinical Trial Registry Platform (WHO ICTRP, the International Committee of Medical Journal Editors requirement- they have not succeeded, probably because they lack the enough power of enforcement. Legislation appears to be the most efficient and effective means to ensure that all researchers register their trials and disseminate their data accurately and in a timely manner. We propose that a global network be established. This could be accomplished in two steps. The first step is to legislate about trial registration and data transparency, such as USA's FDAAA Act 2007; and the second step to establish a global network to ensure uniform, international consistency in policy and enforcement of trial registration and data transparency.

  9. Legislation for trial registration and data transparency.

    Science.gov (United States)

    Bian, Zhao-Xiang; Wu, Tai-Xiang

    2010-05-26

    Public confidence in clinical trials has been eroded by data suppression, misrepresentation and manipulation. Although various attempts have been made to achieve universal trial registration- e.g., Declaration of Helsinki, WHO clinical Trial Registry Platform (WHO ICTRP), the International Committee of Medical Journal Editors requirement- they have not succeeded, probably because they lack the enough power of enforcement.Legislation appears to be the most efficient and effective means to ensure that all researchers register their trials and disseminate their data accurately and in a timely manner. We propose that a global network be established. This could be accomplished in two steps. The first step is to legislate about trial registration and data transparency, such as USA's FDAAA Act 2007; and the second step to establish a global network to ensure uniform, international consistency in policy and enforcement of trial registration and data transparency.

  10. US medical researchers, the Nuremberg Doctors Trial, and the Nuremberg Code. A review of findings of the Advisory Committee on Human Radiation Experiments.

    Science.gov (United States)

    Faden, R R; Lederer, S E; Moreno, J D

    1996-11-27

    The Advisory Committee on Human Radiation Experiments (ACHRE), established to review allegations of abuses of human subjects in federally sponsored radiation research, was charged with identifying appropriate standards to evaluate the ethics of cold war radiation experiments. One central question for ACHRE was to determine what role, if any, the Nuremberg Code played in the norms and practices of US medical researchers. Based on the evidence from ACHRE's Ethics Oral History Project and extensive archival research, we conclude that the Code, at the time it was promulgated, had little effect on mainstream medical researchers engaged in human subjects research. Although some clinical investigators raised questions about the conduct of research involving human beings, the medical profession did not pursue this issue until the 1960s.

  11. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... treatment, screening, diagnostic, prevention, and supportive care trials. Treatment Trials In treatment trials, researchers may gather information about experimental treatments, ...

  12. Cebranopadol, a novel first-in-class analgesic drug candidate: first experience in patients with chronic low back pain in a randomized clinical trial.

    Science.gov (United States)

    Christoph, Annette; Eerdekens, Marie-Henriette; Kok, Maurits; Volkers, Gisela; Freynhagen, Rainer

    2017-09-01

    Chronic low back pain (LBP) is a common condition, usually with the involvement of nociceptive and neuropathic pain components, high economic burden and impact on quality of life. Cebranopadol is a potent, first-in-class drug candidate with a novel mechanistic approach, combining nociceptin/orphanin FQ peptide and opioid peptide receptor agonism. We conducted the first phase II, randomized, double-blind, placebo- and active-controlled trial, evaluating the analgesic efficacy, safety, and tolerability of cebranopadol in patients with moderate-to-severe chronic LBP with and without neuropathic pain component. Patients were treated for 14 weeks with cebranopadol 200, 400, or 600 μg once daily, tapentadol 200 mg twice daily, or placebo. The primary efficacy endpoints were the change from baseline pain to the weekly average 24-hour pain during the entire 12 weeks and during week 12 of the maintenance phase. Cebranopadol demonstrated analgesic efficacy, with statistically significant and clinically relevant improvements over placebo for all doses as did tapentadol. The responder analysis (≥30% or ≥50% pain reduction) confirmed these results. Cebranopadol and tapentadol displayed beneficial effects on sleep and functionality. Cebranopadol treatment was safe, with higher doses leading to higher treatment discontinuations because of treatment-emergent adverse events occurring mostly during titration. Those patients reaching the target doses had an acceptable tolerability profile. The incidence rate of most frequently reported treatment-emergent adverse events during maintenance phase was ≤10%. Although further optimizing the titration scheme to the optimal dose for individual patients is essential, cebranopadol is a new drug candidate with a novel mechanistic approach for potential chronic LBP treatment.

  13. ACT-asthma control y tratamiento para niños: a progress report.

    Science.gov (United States)

    Lewis, M A; de la Sota, A; Rachelefsky, G; Lewis, C E; Quinones, H; Richards, W

    1987-01-01

    A randomized clinical trial is in progress to evaluate an asthma educational program for Latino children and their parents. The intervention, "ACT-Asma Control y Tratamiento Para Niños," was adapted from ACT for Kids, an asthma self-management program for English-speaking families. Results of a pilot study indicated that socioeconomic status was a critical variable to be considered in the design of such programs. Latino children and parents encounter significant barriers to access and continuity of medical care. Therefore, the intervention was redesigned to include "linkages" using a nurse to reduce barriers and to coordinate care. The lesson plans emphasize concrete, experimental learning experiences, with repetition of key points in each session.

  14. 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.

  15. From the Experience of Interactivity and Entertainment to Lower Intention to Smoke: A Randomized Controlled Trial and Path Analysis of a Web-Based Smoking Prevention Program for Adolescents

    Science.gov (United States)

    Wang, Hua; Calabro, Karen Sue; Mitra, Natasha; Shegog, Ross

    2017-01-01

    Adolescents’ experience of interactivity and entertainment contributed to the expected outcome of lower intention to smoke. Also, emphasis needs to be placed on the emotional experience during Web-based interventions in order to maximize reductions in smoking intentions. Going beyond mere evaluation of the effectiveness of a Web-based smoking prevention program, this study contributes to the understanding of adolescents’ psychological experience and its effect on their intention to smoke. With the results of this study, researchers can work to (1) enhance the experience of interactivity and entertainment and (2) amplify concepts of media effects (eg, presence and emotional involvement) in order to better reach health behavior outcomes. Trial Registration Clinicaltrials.gov NCT02469779; https://clinicaltrials.gov/ct2/show/NCT02469779 (Archived by WebCite at http://www.webcitation.org/6nxyZVOf0) PMID:28209560

  16. Bayes' postulate for trinomial trials

    Science.gov (United States)

    Diniz, M. A.; Polpo, A.

    2012-10-01

    In this paper, we discuss Bayes' postulate and its interpretation. We extend the binomial trial method proposed by de Finetti [1] to trinomial trials, for which we argue that the consideration of equiprobability a priori for the possible outcomes of the trinomial trials implies that the parameter vector has Dirichlet(1,1) as prior. Based on this result, we agree with Stigler [2] in that the notion in Bayes' postulate stating "absolutely know nothing" is related to the possible outcomes of an experiment and not to "non-information" about the parameter.

  17. How Experimental Trial Context Affects Perceptual Categorization

    Directory of Open Access Journals (Sweden)

    Thomas J Palmeri

    2015-02-01

    Full Text Available To understand object categorization, participants are tested in experiments often quite different from how people experience object categories in the real world. Learning and knowledge of categories is measured in discrete experimental trials, those trials may or may not provide feedback, trials appear one after another, after some fixed inter-trial interval, with hundreds of trials in a row, within experimental blocks with some structure dictated by the experimental design. In the real world, outside of certain educational and vocational contexts, opportunities to learn and use categories are intermixed over time with a whole multitude of intervening experiences. It is clear from any elementary understanding of human cognition that sequential effects matter, yet this understanding is often ignored, and categorization trials are often instead treated as independent events, immune to local trial context. In this perspective, we use some of our work to illustrate some of the consequences of the fact that categorization experiments have a particular trial structure. Experimental trial context can affect performance in category learning and categorization experiments in ways that can profoundly affect theoretical conclusions.

  18. Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

    Science.gov (United States)

    Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

    2012-07-01

    Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

  19. Progress in the prognosis of adult Hodgkin's lymphoma in the past 35 years through clinical trials in Argentina: a GATLA experience.

    Science.gov (United States)

    Pavlovsky, Santiago; Lastiri, Francisco

    2004-09-01

    The purpose of this study was to evaluate the trends in complete remission (CR) rate, disease-free survival (DFS), and overall survival (OS) through 35 years of Grupo Argentino de Tratamiento de la Leucemia Aguda (GATLA) clinical trials. A total of 1,254 adult patients with Hodgkin's Lymphoma were evaluated according to seven consecutive protocols. This 35-year study was divided into three phases. The patients in the first phase (1968-1985) were treated with CVPP (cyclophosphamide/vinblastine/procarbazine/prednisone) plus involved-field radiotherapy (IFRT). In the CVPP regimen, cyclophosphamide and vinblastine were administered intravenously on day 1 and prednisone and procarbazine were administered orally on days 1-14 every 28 days. The second phase (1986-1996) used mainly reinforced CVPP with cyclophosphamide and vinblastine on days 1-8 plus IFRT. The third phase (1997-2003) used ABVD(doxorubicin/bleomycin/vinblastine/dacarbazine) plus IFRT. In clinical stage I/II, the CR rate was 86% in 252 patients treated in the first phase and DFS and OS were 57% and 78% at 5 years and 50% and 71% at 10 years. The second phase had 148 patients with clinical stage I/II disease, and the CR rate was 91%, 5-year DFS and OS were 78% and 90%, and 10-year DFS and OS were 70% and 83%. The third phase had 182 patients with clinical stage I/II disease, and the CR rate was 95%, 5-year DFS and OS were 87% and 96%, and 10-year DFS and OS were not reached. The statistical difference was P = 0.016 in terms of CR and P < 0.001 in terms of DFS and OS. In the first phase of 394 patients with clinical stage III/IV disease, the CR rate was 71%, DFS and OS at 5 years were 37% and 62%, and DFS and OS at 10 years were 32% and 53%. In the second phase of 164 patients with clinical stage III/IV disease, the CR rate was 84%, DFS and OS at 5 years were 66% and 80%, and DFS and OS at 10 years were 60% and 75%. In the third phase of 114 patients with clinical stage III/IV disease, the CR rate was 88% and

  20. Control of soil-transmitted helminthiasis in Yunnan province, People's Republic of China: experiences and lessons from a 5-year multi-intervention trial.

    Science.gov (United States)

    Steinmann, Peter; Yap, Peiling; Utzinger, Jürg; Du, Zun-Wei; Jiang, Jin-Yong; Chen, Ran; Wu, Fang-Wei; Chen, Jia-Xu; Zhou, Hui; Zhou, Xiao-Nong

    2015-01-01

    The current global strategy for the control of soil-transmitted helminthiasis emphasises periodic administration of anthelminthic drugs to at-risk populations. However, this approach fails to address the root social and ecological causes of soil-transmitted helminthiasis. For sustainable control, it has been suggested that improvements in water, sanitation and hygiene behaviour are required. We designed a 5-year multi-intervention trial in Menghai county, Yunnan province, People's Republic of China. Three different interventions were implemented, each covering a village inhabited by 200-350 people. The interventions consisted of (i) initial health education at study inception and systematic treatment of all individuals aged ≥2 years once every year with a single dose of albendazole; (ii) initial health education and bi-annual albendazole administration; and (iii) bi-annual treatment coupled with latrine construction at family level and regular health education. Interventions were rigorously implemented for 3 years, whilst the follow-up, which included annual albendazole distribution, lasted for 2 more years. Before the third round of treatment, the prevalence of Ascaris lumbricoides was reduced by only 2.8% in the annual treatment arm, whilst bi-annual deworming combined with latrine construction and health education resulted in a prevalence reduction of 53.3% (p<0.001). All three control approaches significantly reduced the prevalence of Trichuris trichiura and hookworm, with the highest reductions achieved when chemotherapy was combined with sanitation and health education. The prevalence of T. trichiura remained at 30% and above regardless of the intervention. Only bi-annual treatment combined with latrine construction and health education significantly impacted on the prevalence of Taenia spp., but none of the interventions significantly reduced the prevalence of Strongyloides stercoralis. Our findings support the notion that in high-endemicity areas

  1. Indirect Speech Acts

    Institute of Scientific and Technical Information of China (English)

    李威

    2001-01-01

    Indirect speech acts are frequently used in verbal communication, the interpretation of them is of great importance in order to meet the demands of the development of students' communicative competence. This paper, therefore, intends to present Searle' s indirect speech acts and explore the way how indirect speech acts are interpreted in accordance with two influential theories. It consists of four parts. Part one gives a general introduction to the notion of speech acts theory. Part two makes an elaboration upon the conception of indirect speech act theory proposed by Searle and his supplement and development of illocutionary acts. Part three deals with the interpretation of indirect speech acts. Part four draws implication from the previous study and also serves as the conclusion of the dissertation.

  2. What Are Clinical Trials?

    Science.gov (United States)

    ... of this page please turn Javascript on. Feature: Clinical Trials What Are Clinical Trials? Past Issues / Fall 2010 Table of Contents Clinical ... conducted all the time. The Different Phases of Clinical Trials Clinical trials related to drugs are classified into ...

  3. Participating in Clinical Trials

    Science.gov (United States)

    ... this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical ... to treat or cure a disease. Phases of Clinical Trials Clinical trials of drugs are usually described based ...

  4. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Usually, trial participants must show signs of the disease or condition before they can join this type of trial. Prevention Trials Click for more information In prevention trials, ...

  5. 幼儿快乐体验学习语言的尝试%Trial on Infant's Happy Experience in Language Education

    Institute of Scientific and Technical Information of China (English)

    刘敏智

    2012-01-01

    语言是人类交际和扩展生活的重要工具,幼儿期是学习语言的关键时期,这一时期语言能力的发展,对幼儿今后各种能力的发展以及知识的获得,人格的健全乃至整个心理结构的发展都具有决定性意义。笔者结合《纲要》不断学习其内容与要求,更新自己的教育理念,为真正领会《纲要》精神,在实施语言课题中努力研究和探索新的教育教学方法,使幼儿走进了快乐的语言园地,并会运用这种情感体验,从而发展了幼儿的语言能力,使幼儿体验语言的快乐。%Language is an important tool of the human communication and extended life,early childhood is a critical period of language learning,this period of language development of children in the future,all capacity development and the acquisition of knowledge,personality and the mental structure of the development is of decisive significance.The author combine" compendium" learning the content and requirements,to update their education ideas,to truly understand the" compendium" spirit,the implementation language subject to study and explore new teaching methods,so that the children into a happy language corner,and will use this kind of emotional experience,thus the development of children's language ability,so that children experience the happiness of language.

  6. The act of interpretation.

    Science.gov (United States)

    D'Abreu, Aloysio Augusto

    2006-08-01

    The author understands the interpreting act as an attempt to perceive what happens in the transference/countertransference field and not just what happens in the patient's mind. Interpretation transcends mere intellectual communication. It is also an experience in which analysts' emotions work as an important instrument in understanding their patients. Interpretation is seen to possess manifest as well as latent content; the latter would contain the analysts' feelings, emotions and personality. The unconscious content of an interpretation does not inconvenience or preclude the development of the analytic process, but, on the contrary, it allows new associative material to emerge, and it transforms the analytic session into a human relationship. Analysts' awareness of this content derived from patients' apperceptions is a significant instrument for understanding what is happening in the analytic relationship, and what transpires in these sessions provides fundamental elements for analysts' self-analysis. Some clinical examples demonstrate these occurrences in analytic sessions, and how they can be apprehended and used for a better understanding of the patient. The author also mentions the occurrence of difficulties during the analytic process. These difficulties are often the result of lapses in an analyst's perception related to unconscious elements of the relationship.

  7. Dealing with daily challenges in dementia (deal-id study): effectiveness of the experience sampling method intervention 'Partner in Sight' for spousal caregivers of people with dementia: design of a randomized controlled trial.

    Science.gov (United States)

    van Knippenberg, Rosalia J M; de Vugt, Marjolein E; Ponds, Rudolf W; Myin-Germeys, Inez; Verhey, Frans R J

    2016-05-11

    There is an urgent need for psychosocial interventions that effectively support dementia caregivers in daily life. The Experience Sampling Methodology (ESM) offers the possibility to provide a more dynamic view of caregiver functioning. ESM-derived feedback may help to redirect caregivers' behavior towards situations that elicit positive emotions and to increase their feelings of competence in the caretaking process. This paper presents the design of a study that evaluates the process characteristics and effects of the ESM-based intervention 'Partner in Sight'. A randomized controlled trial with 90 spousal caregivers of people with dementia will be conducted. Participants will be randomly assigned to the experimental (6-week ESM intervention including feedback), pseudo-experimental (6-week ESM intervention without feedback), or control group (care as usual). Assessments will be performed pre- and post-intervention and at 2-, and 6-month follow-up. Main outcomes will be sense of competence, perceived control, momentary positive affect, and psychological complaints (depressive symptoms, perceived stress, anxiety, momentary negative affect). In addition to the effect evaluation, a process and economic evaluation will be conducted to investigate the credibility and generalizability of the intervention, and its cost-effectiveness. The potential effects of the ESM intervention may help caregivers to endure their care responsibilities and prevent them from becoming overburdened. This is the first ESM intervention for caregivers of people with dementia. The results of this study, therefore, provide a valuable contribution to the growing knowledge on m-health interventions for dementia caregivers. Dutch Trial Register NTR4847 ; date registered Oct 9, 2014.

  8. Adubação da batatinha experiências com adubos minerais e farelo de cacau Fertilizer experiments with potatoes trials with mineral fertilizers and cocoa-shell meal

    Directory of Open Access Journals (Sweden)

    O. J. Boock

    1960-01-01

    Full Text Available No período de 1946 a 1950 foram conduzidas duas experiências era Tupi Paulista e três em Mococa, para estudar o efeito, sôbre a produção da batatinha (Solarium tuberosum L., da adição de farelo de cacau a adubações minerais contendo 40-120-60 e 80-120-60 kg/ha de N-P(20(5-K(20. O farelo em apreço, que é um dos subprodutos da indústria do chocolate e consta principalmente de películas das amêndoas (sementes de cacau, foi adicionado em doses que variaram entre 255 e 1100 kg/ha. A adição de farelo deprimiu um pouco a produção em Tupi, sendo que a depressão foi maior no tratamento que recebeu a menor dose de nitrogênio; em Mococa seu efeito foi positivo e apreciável na presença de 80-120-60, mas praticamente nulo quando adicionado a 40-120-60. Isso parece indicar que, na sua decomposição, o farelo deprimiu as disponibilidades do solo em nitrogênio assimilável. Assim, para estudar a conveniência de sua adição, dever-se-ía empregá-lo com bastante antecedência ao plantio; para aplicá-lo ao ser este efetuado, como nas experiências relatadas, o farelo deveria ser previamente curtido.This paper reports the results obtained in five experiments conducted from 1946 to 1950 and designed to study the effect of the addition of cocoa-shell meal to mineral fertilizers supplying 40-120-60 and 80-120-60 kilograms of N-P(20(5-K2O per hectare. The mentioned meal, which is a by-product of the cocoa industry and consists essentially of the shells of the cocoa beans, was applied at rates varying from 255 to 1,100 kilograms per hectare. Two of the experiments were located at Tupi Paulista and the other three at Mococa, State of São Paulo. On the average, in the Tupj experiments the addition of cocoa-shell meal reduced slightly the potato yields, the reduction being greater in the presence of the fertilizer containing the smaller quantity of nitrogen; at Mococa it increased appreciably the yield in the presence of 80-120-60, but was

  9. Adubação do milho: XVIII - Ensaios com diversos fosfatos (4.ª série. Fertilizer experiments with corn: XVIII - Trials with various phosphorus sources (4th series

    Directory of Open Access Journals (Sweden)

    G.P Viégas

    1961-01-01

    first year. In three of the four trials superphosphate was much superior to hyperphosphate and mainly to Serrote-phosphate (from the Serrote hill, near Juquiá. State of São Paulo; in the other trial the last two types of phosphates gave similar results and were only a little inferior to superphosphate. Florida-phosphate, included in two experiments, was practically equal to byperphosphate. The superiority of superphosphate came chiefly from its greater efficiency in the first year; star-ling from the second year the tendency was for equivalence of the phosphates studied. In the experiment conducted for five years the lime application was ineffective in the first two years, but il increased appreciably the yields in the following years. In another experiment, couduceted for two years in a move acid soil, lime was fairly effective even in the first and very effective in the second year. The addition of lime enhanced the effect of superphosphate, but affected contradictorily those of the natural phosphates.

  10. Varied acceptance of clinical trial results.

    Science.gov (United States)

    Klimt, C R

    1989-12-01

    The subject of varied acceptance of clinical trial results is discussed in the context of review of trials with which I have been involved and my subjective evaluation of their impact on the practice of clinical medicine. My experience goes back to 1949 and a World Health Organization trial of hyperimmune gamma globulin against rabies. This was followed by a large trial of secondary prevention of poliomyelitis. I participated in the planning and initiation of the first chronic disease trial, the University Group Diabetes Program (UGDP). The latter lasted for 15 years and its ramifications continue to this day. My next trial was the Coronary Drug Project (CDP), a complex trial with more than 8,000 patients. The trials of aspirin and aspirin combined with persantine (the CDPA, AMIS, PARIS I, and PARIS II) followed. My last three trials were a trial of photocoagulation in diabetic retinopathy (DRS), a six-country trial of the antiarrhythmic drug mexiletine (IMPACT), and a study involving two diagnostic procedures for pulmonary embolism (PIOPED). When one considers, in retrospect, the plethora of trials one is struck by the uniform absence of a priori considerations of the impact on medical practice, or likely lack thereof, of possible outcomes.

  11. ACT Verbal Prep Course

    CERN Document Server

    Standridge, Nathan

    2012-01-01

    Comprehensive Prep for ACT Verbal. Every year, students pay 1,000 and more to test prep companies to prepare for the verbal sections of the ACT. Now you can get the same preparation in a book. The verbal sections are not easy. There is no quick fix that will allow you to "beat" the ACT, but it is very learnable. If you study hard and master the techniques in this book, your score will improve-significantly. The ACT cannot be "beaten." But it can be mastered-through hard work, analytical thought, and by training yourself to think like a test writer. Many of the exercises in this book are design

  12. Quantum measurement act as a "speech act"

    CERN Document Server

    Schneider, J

    2005-01-01

    I show that the quantum measurement problem can be understood if the measurement is seen as a ``speech act'' in the sense of modern language theory. The reduction of the state vector is in this perspective an intersubjectice -- or better a-subjective -- symbolic process. I then give some perspectives on applications to the ``Mind-Body problem''.

  13. Data monitoring committees for pragmatic clinical trials.

    Science.gov (United States)

    Ellenberg, Susan S; Culbertson, Richard; Gillen, Daniel L; Goodman, Steven; Schrandt, Suzanne; Zirkle, Maryan

    2015-10-01

    In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the interests of research participants and ensuring trial integrity in many trials. Many pragmatic clinical trials, which aim to inform healthcare decisions by comparing alternate interventions in heterogeneous healthcare delivery settings, will warrant review by an independent data monitoring committee due to their potential impact on clinical practice. However, the very features that make a trial "pragmatic" may pose challenges in terms of which aspects of a trial to monitor and when it is appropriate for a data monitoring committee to intervene. Using the Pragmatic-Explanatory Continuum Indicator Summary tool that draws distinctions between pragmatic and explanatory clinical trials, we review characteristics of pragmatic clinical trials that may have implications for data monitoring committees and interim monitoring plans. These include broad eligibility criteria, a focus on subjective patient-centered outcomes, and in some cases a lack of standardized follow-up procedures across study sites. Additionally, protocol adherence is often purposefully not addressed in pragmatic trials in order to accurately represent the clinical practice setting and maintain practicability of implementation; there are differing viewpoints as to whether adherence should be assessed and acted upon by data monitoring committees in these trials. Some other issues not specifically related to the Pragmatic-Explanatory Continuum Indicator Summary criteria may also merit special consideration in pragmatic trials. Thresholds for early termination of a pragmatic clinical trial might be controversial. The distinguishing features of pragmatic clinical

  14. Adubação do milho: XV - Ensaios com diversos fosfatos (1. ª série Fertilizer experiments with corn: XV - Trials with various phosphorus sources (1st series

    Directory of Open Access Journals (Sweden)

    G. P. Viégas

    1960-01-01

    Full Text Available Há muito tempo que o Instituto Agronômico vem realizando experiências para determinar a eficiência relativa de vários fosfatos na adubação do milho. Como até agora só foram publicados os resultados obtidos em algumas delas, os autores resolveram relatar, em séries, os que ainda se acham inéditos. No conjunto desta primeira série, constituída de seis ensaios iniciados até 1940-41 e cujos planos variaram consideravelmente, em regra superfosfato e Renânia-fosfato se mostraram equivalentes e foram superiores a farinha de ossos crus, farinha de ossos degelatinados, escórias de Thomas, Serrana fosfato, Cibrafosfato e Rofosfato. Em um ensaio, .superfosfato e Renánia-tosfato loram bem inferiores a farinha de ossos degelatinados; mas esta, por sua vez, ficou praticamente sem efeito em outro ensaio, no qual os dois primeiros adubos deram resultados satisfatórios. Superfosfato granulado, que figurou em dois ensaios, foi um pouco superior ao produto comum em um deles e muito inferior no outro. Rofoscal, estudado em um ensaio, não aumentou a produção. Todavia, tis autores advertem que o pequeno número de ensaios deste grupo e as condições em que eles foram conduzidos não permitem tirar conclusões seguras, o que se procurará fazer após a publicação das outras séries.The relative efficiency of various phosphorus fertilizers for com has been tested in lhe Instituto Agronômico for many years. In this paper the authors report the results obtained in the first series consisting of six experiments started before 1941. As a whole, ordinary superphosphate and Rhenania phosphate gave similar results and were superior to Thomas slag, bone meal, Serranaphosphate, Cibraphosphate and Rophos-phate. Granulated superphosphate, which was included in two experiments, was a little superior to the ordinary product in one and much inferior in the other. Rofoscal, studied in one trial, did not increase the yield. The authors warn, however, that the

  15. Ensaio de cultivares e híbridos de morangueiro, Jundiaí, 1971 Strawberry cultivar trial at Jundiaí experiment station

    Directory of Open Access Journals (Sweden)

    Leocádio de Souza Camargo

    1974-01-01

    Full Text Available São apresentados os resultados de ensaio de competição de cinco cultivares e híbridos de morangueiro (Fragaria híbridos, realizado em 1971 na Estação Experimental de Jundiaí, SP, região de altitude aproximada de 715 m e latitude 23° e 6'S. O município de Jundiaí e os municípios vizinhos são os maiores produtores de morango do Brasil. Os cultivares estudados foram os seguintes: Campinas, Monte Alegre, Mantiqueira, Híbrido 1AC-4703 e Dr. Morère ou Comum. A colheita se estendeu de maio a novembro, para os cultivares Campinas, Monte Alegre e Híbrido IAC-4703. Foram tardios na produção de frutos, colhendo-se de julho a novembro, os cultivares Mantiqueira e Dr. Morère ou Comum. Com relação a precocidade, produtividade e características comerciais de produto - tamanho, paladar, coloração, firmeza dos frutos - obtiveram-se resultados significantemente superiores com os cultivares Campinas e Monte Alegre.A comparative study of strawberry cultivars (Fragaria hb. and hybrids was carried out at the Jundiaí Experiment Station, in 1971. The cultivar "Dr. Morère", also called "Comum", formerly the most cultivated in the State of São Paulo, was included as a standard. April 16 was the planting date. The cultivars were statistically compared on the basis of total yield of fruits (harvested from May to November and on early yield (corresponding to the May to July harvest. The cultivars were Campinas (IAC-2712, Monte Alegre (IAC-3113, Hybrid IAC-4703, Mantiqueira (IAC-3976 and Dr. Morère or Comum (I-699. Campinas (IAC-2712, Monte Alegre (IAC-3113 and Hybrid IAC-4703 showed significantly higher total yield than the others. Monte Alegre (IAC-3113 proved to be the earliest in yield followed by Campinas (IAC-2712. Dr. Morère and Mantiqueira were the latest in yield. Campinas and Monte Alegre were superior to the other cultivars also in characters as fruit size, taste, color and firmness.

  16. The Apocryphal Acts Of Andrew

    NARCIS (Netherlands)

    Bremmer, Jan N.

    2000-01-01

    Following the first three volumes of the new series on the Acts of John (1995), the Acts of Paul and Thecla (1996) and the Acts of Peter (1998), this new volume is devoted to the Acts of Andrew. After a study of the relationship between the Acts of Andrew and the Acts of Andrew and Matthias, the maj

  17. Adubação da mamoneira: V - Experiência com vários fosfatos em solo do arenito Botucatu Fertilizer experiments with castor beans: V - Trial with several phosphorus sources

    Directory of Open Access Journals (Sweden)

    José Luiz V. Rocha

    1964-01-01

    Full Text Available Numa experiência de adubação da mamoneira (Ricinus communis L,, conduzida por dois anos em solo derivado do arenito Botucatu, com vegetação de cerrado, superfosfato simples foi comparado, na presença de NK, com fosforita de Olinda, fosfato de Araxá e misturas que continham 1/3, 1/2 ou 2/3 da dose total de P2O5 (65 kg/ha como superfosfato, sendo o resto fornecido por um dos fosfatos naturais. Em média dos dois anos, a produção do tratamento sem adubo foi de 196 kg/ha, ao passo que as dos melhores tratamentos oscilaram em tôrno de 650 kg/ha. Embora muito superiores à do tratamento sem adubo, as últimas produções foram apenas sofríveis, aparentemente devido à insuficiência das adubações usadas e a fatores adversos no segundo ano. Empregados sòzinhos, os fosfatos naturais mostraram-se muito inferiores ao superfosfato; nas misturas, porém, não diferiram um do outro nem do adubo padrão. O efeito das misturas diminuiu quando se reduziu a contribuição de superfosfato, mas as diferenças foram pequenas. O efeito residual de PK, verificado no segundo ano, em parte da experiência, correspondeu a cêrca de 1/3 da resposta a NPK, obtida nos canteiros que receberam essa adubação nos dois anos.In the experiment reported, conducted for two years on poor soil derived from the Botucatu sandstone, superphosphate was compared, in the presence of NK with Olinda and Araxa phosphates (ground natural phosphates, and mixtures containing 1/3, 1/2 and 2/3 of the total dosis of P2O5 (65 kilograms per hectare as superphosphate, the remaining being supplied by one of the natural phosphates. The average yield of the two years was only 196 kg/ha (kilograms per hectare in the unfertilized plots and varied around 650 kg/ha in the better treatments. Although much higher than that of the unfertilized treatment, the latter yields were unsatisfactory, apparently due to the use of inadequate rates of application, deficiency of elements other than those

  18. Marine Mammal Protection Act

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The Marine Mammal Protection Act (MMPA or Act) prohibits, with certain exceptions, the "take" of marine mammals in U.S. waters and by U.S. citizens on the high seas,...

  19. Types of Treatment: Clinical Trials

    Science.gov (United States)

    ... Disease Information Treatment Types of Treatment Clinical Trials Clinical Trials Clinical Trials SHARE: Print Glossary Taking part in a clinical ... for cancer are based on previous clinical trials. Clinical Trial Service: LLS provides personalized clinical trial navigation when ...

  20. HVAC Trials.

    Science.gov (United States)

    Greim, Clifton W.; D'Angelo, David

    1999-01-01

    Explains how commissioning can help to ensure that all components in a new heating, ventilation, and air conditioning system will work together as designed. Bowdoin College's experience with commissioning is highlighted. (GR)

  1. HVAC Trials.

    Science.gov (United States)

    Greim, Clifton W.; D'Angelo, David

    1999-01-01

    Explains how commissioning can help to ensure that all components in a new heating, ventilation, and air conditioning system will work together as designed. Bowdoin College's experience with commissioning is highlighted. (GR)

  2. Modelling trial-by-trial changes in the mismatch negativity.

    Directory of Open Access Journals (Sweden)

    Falk Lieder

    Full Text Available The mismatch negativity (MMN is a differential brain response to violations of learned regularities. It has been used to demonstrate that the brain learns the statistical structure of its environment and predicts future sensory inputs. However, the algorithmic nature of these computations and the underlying neurobiological implementation remain controversial. This article introduces a mathematical framework with which competing ideas about the computational quantities indexed by MMN responses can be formalized and tested against single-trial EEG data. This framework was applied to five major theories of the MMN, comparing their ability to explain trial-by-trial changes in MMN amplitude. Three of these theories (predictive coding, model adjustment, and novelty detection were formalized by linking the MMN to different manifestations of the same computational mechanism: approximate Bayesian inference according to the free-energy principle. We thereby propose a unifying view on three distinct theories of the MMN. The relative plausibility of each theory was assessed against empirical single-trial MMN amplitudes acquired from eight healthy volunteers in a roving oddball experiment. Models based on the free-energy principle provided more plausible explanations of trial-by-trial changes in MMN amplitude than models representing the two more traditional theories (change detection and adaptation. Our results suggest that the MMN reflects approximate Bayesian learning of sensory regularities, and that the MMN-generating process adjusts a probabilistic model of the environment according to prediction errors.

  3. A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial: study rationale and design

    Directory of Open Access Journals (Sweden)

    Kristensen Peter

    2012-06-01

    Full Text Available Abstract Background Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial. Methods/design The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE, multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year. Discussion In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov: NCT00346996.

  4. 75 FR 63703 - Privacy Act of 1974; Privacy Act Regulation

    Science.gov (United States)

    2010-10-18

    ... CFR Part 261a Privacy Act of 1974; Privacy Act Regulation AGENCY: Board of Governors of the Federal...) is issuing a final rule to amend its regulation implementing the Privacy Act of 1974 (Privacy Act..., and applicants for Board employment, for access to their records under the Privacy Act; the amendment...

  5. Terminating a long-term clinical trial.

    Science.gov (United States)

    Klimt, C R

    1981-05-01

    Long-term clinical trials often include more than one active treatment group. These may be discontinued independently if found to be ineffective or possibly harmful. Certain subgroups of patients may be discovered, in the course of a clinical trial, who do not respond satisfactorily and are, therefore, excluded during the course of a trial. Yet another kind of termination comes when we have a therapeutic breakthrough or when hope has to be abandoned for demonstrating beneficial effects for one, several, or all treatments included in a trial. Examples from the authors' experience are presented, as are successful and unsuccessful techniques in managing terminations of various types.

  6. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... trial is to find out if an experimental drug, therapy, medical device, lifestyle change, or test will ... disease. Phases of Clinical Trials Clinical trials of drugs are usually described based on their phase. The ...

  7. National Environmental Policy Act

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The National Environmental Policy Act (NEPA) was the first major environmental law in the United States and established national environmental policies for the...

  8. Acts of Research

    DEFF Research Database (Denmark)

    Nelund, Sidsel

    with an awareness of larger political, economic, geographical and art-related aspects. The concept of ‘acts of research’ is suggested as a way to understand knowledge production as a creative act in which research carried out in relation to a specific material challenges and resists the protocols of conventional...... described as knowledge producers and exhibitions and art works as instances of knowledge production. Acts of Research: Knowledge Production in Contemporary Arts between Knowledge Economy and Critical Practices analyses this development. The academic discussion of knowledge production in the arts has taken...... place mostly in seminars and articles, in which knowledge is often discussed as an intrinsic quality of the artwork. Acts of Research, however, is devoted to studying the rise of knowledge production in contemporary art from the perspective of artistic, curatorial and educational research...

  9. Abandoned Shipwreck Act

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The Abandoned Shipwreck Act of 1987 (ASA) affirms the authority of state governments to claim ownership to, protect, and manage abandoned shipwrecks on state...

  10. Marine Pollution Prevention Act

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The Marine Pollution Prevention Act of 2008 implements the International Convention for the Prevention of Pollution from Ships, including related Protocols (MARPOL)...

  11. Clean Water Act

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The Clean Water Act (CWA) establishes the basic structure for regulating discharges of pollutants into U.S. waters and regulating quality standards for surface...

  12. Affordable Care Act (ACA)

    Data.gov (United States)

    Social Security Administration — The Affordable Care Act (ACA) is a federal statute enacted with a goal of increasing the quality and affordability of health insurance. Through a web service, CMS...

  13. Endangered Species Act

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The purpose of the Endangered Species Act (ESA) is to protect and recover imperiled species and the ecosystems upon which they depend. The U.S. Fish and Wildlife...

  14. ACT250 Districts

    Data.gov (United States)

    Vermont Center for Geographic Information — The ACT 250 Districts layer is part of a larger dataset that contains administrative boundaries for Vermont's Agency of Natural Resources. The dataset includes...

  15. Energy Policy Act

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The Energy Policy Act (EPA) addresses energy production in the United States, including: (1) energy efficiency; (2) renewable energy; (3) oil and gas; (4) coal; (5)...

  16. The Corporations Act 2001

    OpenAIRE

    Bostock, Tom

    2002-01-01

    The author outlines reforms made in Australia in the area of company law with an analysis of the Corporations Act 2001, which along with the Australian Securities and Investments Commission Act 2001 comprises Corporations legislation in Australia. Article by Tom Bostock (a partner in the law firm Mallesons Stephen Jaques, Melbourne, Australia). Published in Amicus Curiae - Journal of the Institute of Advanced Legal Studies and its Society for Advanced Legal Studies. The Journal is produced by...

  17. Monitoring antimalarial safety and tolerability in clinical trials: A case study from Uganda

    Directory of Open Access Journals (Sweden)

    Mpimbaza Arthur

    2008-06-01

    Full Text Available Abstract Background New antimalarial regimens, including artemisinin-based combination therapies (ACTs, have been adopted widely as first-line treatment for uncomplicated malaria. Although these drugs appear to be safe and well-tolerated, experience with their use in Africa is limited and continued assessment of safety is a priority. However, no standardized guidelines for evaluating drug safety and tolerability in malaria studies exist. A system for monitoring adverse events in antimalarial trials conducted in Uganda was developed. Here the reporting system is described, and difficulties faced in analysing and interpreting the safety results are illustrated, using data from the trials. Case description Between 2002 and 2007, eleven randomized, controlled clinical trials were conducted to compare the efficacy, safety, and tolerability of different antimalarial regimens for treatment of uncomplicated malaria in Uganda. The approach to adverse event monitoring was similar in all studies. A total of 5,614 treatments were evaluated in 4,876 patients. Differences in baseline characteristics and patterns of adverse event reporting were noted between the sites, which limited the ability to pool and analyse data. Clinical failure following antimalarial treatment confounded associations between treatment and adverse events that were also common symptoms of malaria, particularly in areas of lower transmission intensity. Discussion and evaluation Despite prospectively evaluating for adverse events, limitations in the monitoring system were identified. New standardized guidelines for monitoring safety and tolerability in antimalarial trials are needed, which should address how to detect events of greatest importance, including serious events, those with a causal relationship to the treatment, those which impact on adherence, and events not previously reported. Conclusion Although the World Health Organization has supported the development of

  18. On the methodology of drug trials in migraine with aura

    DEFF Research Database (Denmark)

    Hauge, Anne Werner; Hougaard, Anders; Olesen, Jes

    2010-01-01

    INTRODUCTION: Specific problems occur in clinical treatment trials for migraine with aura that differ from those encountered in treatment trials for migraine without aura. DISCUSSION: Based on our experience with four such trials, we point to a number of possible solutions and outline areas...

  19. Microbicide clinical trial adherence: insights for introduction

    Directory of Open Access Journals (Sweden)

    Cynthia Woodsong

    2013-04-01

    Full Text Available After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1 Adherence measurement in clinical trials, (2 Comprehension of use instructions/Instructions for use, (3 Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4 Partner influence on use, (5 Retention and continuation and (6 Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.

  20. The Effects of a Single Reminder Trial on Retention of a Motor Skill

    Science.gov (United States)

    Fairbrother, Jeffrey T.; Shea, John B.

    2005-01-01

    Two experiments investigated the effects of a single reminder trial on immediate and delayed retention. Experiment 1 determined if beneficial effects of a reminder mat were a function of task order. Immediate retention performance benefited only when the reminder trial was practiced in the first block of trials. Experiment 2 added a 24-hr delayed…

  1. CONSIDERATIONS UPON ASSIMILATED ADMINISTRATIVE ACTS

    OpenAIRE

    2011-01-01

    Although the classic administrative courts know as object the acts against classic administrative acts, it should not be lost sight of the assimilated administrative acts, which also may be subject to acts in this litigation. Taking in consideration this category of acts, this study will examine the documents falling into this category and the impact that such acts have on public authorities. Given the significant increase of administrative cases that have as object assimilated administrative...

  2. The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

    Directory of Open Access Journals (Sweden)

    Scardino Peter T

    2009-03-01

    Full Text Available Abstract Introduction Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients on- and off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization.

  3. Clinical Trials in Vision Research

    Science.gov (United States)

    ... Eye Health Information > Clinical Trials in Vision Research Clinical Trials in Vision Research Clinical studies depend on people ... vision research in the United States. Basics of Clinical Trials What is a clinical trial? Clinical trials are ...

  4. How Do Clinical Trials Work?

    Science.gov (United States)

    ... Studies NHLBI Trials Clinical Trial Websites How Do Clinical Trials Work? If you take part in a clinical ... protect patients and help produce reliable study results. Clinical Trial Protocol Each clinical trial has a master plan ...

  5. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... trial. Prevention Trials Click for more information In prevention trials, researchers study ways to reduce the risk of getting a disease or a specific medical problem. These trials find out if lifestyle changes, such as exercising more, getting more sleep, ...

  6. The ACTS multibeam antenna

    Science.gov (United States)

    Regier, Frank A.

    1992-01-01

    The Advanced Communications Technology Satellite (ACTS) to be launched in 1993 is briefly introduced. Its multibeam antenna, consisting of electrically similar 30 GHz receive and 20 GHz transmit offset Cassegrain systems, both utilizing orthogonal polarizations, is described. Dual polarization is achieved by using one feed assembly for each polarization in conjunction with nested front and back subreflectors, the gridded front subreflector acting as a window for one polarization and a reflector for the other. The antennas produce spot beams with approximately 0.3 degree beamwidth and gains of approximately 50 dbi. High surface accuracy and high edge taper produce low sidelobe levels and high cross-polarization isolation. A brief description is given of several Ka-band components fabricated for ACTS. These include multiflare antenna feedhorns, beam-forming networks utilizing latching ferrite waveguide switches, a 30 GHz HEMT low-noise amplifier and a 20 GHz TWT power amplifier.

  7. The ACTS multibeam antenna

    Science.gov (United States)

    Regier, Frank A.

    1992-06-01

    The Advanced Communications Technology Satellite (ACTS) to be launched in 1993 is briefly introduced. Its multibeam antenna, consisting of electrically similar 30 GHz receive and 20 GHz transmit offset Cassegrain systems, both utilizing orthogonal polarizations, is described. Dual polarization is achieved by using one feed assembly for each polarization in conjunction with nested front and back subreflectors, the gridded front subreflector acting as a window for one polarization and a reflector for the other. The antennas produce spot beams with approximately 0.3 degree beamwidth and gains of approximately 50 dbi. High surface accuracy and high edge taper produce low sidelobe levels and high cross-polarization isolation. A brief description is given of several Ka-band components fabricated for ACTS. These include multiflare antenna feedhorns, beam-forming networks utilizing latching ferrite waveguide switches, a 30 GHz HEMT low-noise amplifier and a 20 GHz TWT power amplifier.

  8. Clinical trials. A pending subject.

    Science.gov (United States)

    Gil-Extremera, B; Jiménez-López, P; Mediavilla-García, J D

    2017-07-31

    Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige. The authors have created a synthesis of their experience with clinical trials on hypertension, diabetes, dyslipidaemia and ischaemic heart disease over the course of almost 3 decades. Furthermore, a brief reference has been made to the characteristics of a phase I unit, as well as to a number of research studies currently underway. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  9. Gaps in health insurance: why so many Americans experience breaks in coverage and how the Affordable Care Act will help: findings from the Commonwealth Fund Health Insurance Tracking Survey of U.S. Adults, 2011.

    Science.gov (United States)

    Collins, Sara R; Robertson, Ruth; Garber, Tracy; Doty, Michelle M

    2012-04-01

    The Commonwealth Fund Health Insurance Tracking Survey of U.S. Adults finds that one-quarter of adults ages 19 to 64 experienced a gap in their health insurance in 2011, with a majority remaining uninsured for one year or more. Losing or changing jobs was the primary reason people experienced a gap. Compared with adults who had continuous coverage, those who experienced gaps were less likely to have a regular doctor and less likely to be up to date with recommended preventive care tests, with rates declining as the length of the coverage gap increases. Early provisions of the Affordable Care Act are already helping bridge gaps in coverage among young adults and people with preexisting conditions. Beginning in 2014, new affordable health insurance options through Medicaid and state insurance exchanges will enable adults and their families to remain insured even in the face of job changes and other life disruptions.

  10. Good intentions and ICH-GCP: Trial conduct training needs to go beyond the ICH-GCP document and include the intention-to-treat principle.

    Science.gov (United States)

    Browne, Lois H; Graham, Peter H

    2014-12-01

    It is assumed investigators and statisticians fully understand the importance of avoiding missing outcomes and the intention-to-treat principle during design and analysis phases of a randomised controlled trial in order to obtain the most valuable and reliable results. However, many personnel undertaking day-to-day trial conduct and data collection commonly rely exclusively for guidance on the widely implemented, indeed regulated, International Conference on Harmonisation-Good Clinical Practice document as the guideline and standard for trial conduct. This article describes adverse consequences of omission of intention-to-treat principles from training for trial personnel and explores the need for training in addition to the International Conference on Harmonisation-Good Clinical Practice guideline document. Data from the Breast Boost Study were used to illustrate a comparison of actual results, where vigilant senior investigators re-enforced intention-to-treat requirements throughout all aspects of trial conduct with results that could easily have occurred if study personnel did not understand the importance of intention-to-treat principles. Experience as a co-ordinating centre for an international trial (Trans-Tasman Radiation Oncology Group 08.06 Breast STARS) acted as an audit of data-management culture regarding intention-to-treat in Australia and New Zealand. Despite the Breast Boost Study exceeding planned accrual, it was demonstrated that the study, which found a statistically significant result, could have reported a negative or inconclusive result under the scenario of trial conduct personnel having lack of understanding of the importance of avoiding losses to follow-up. Trans-Tasman Radiation Oncology 08.06 co-ordination experience verified that data-management culture in Australia and New Zealand does not adequately recognise intention-to-treat principles, and this is reflected in trial conduct. Trial data described are limited to two trials and in the

  11. Acting like a Pro

    Science.gov (United States)

    Walker, Marlon A.

    2012-01-01

    The Saturday morning acting class in the Pearson Hall auditorium at Miles College boasts the school's highest attendance all year. The teacher, actress Robin Givens, was a lure few students--and others from surrounding areas--could resist. Some came to learn about their prospective field from a professional. Others were there for pointers to…

  12. An Act of Colonization

    DEFF Research Database (Denmark)

    Rasmussen, Anders Bo

    and the United States signed an act on July 19, 1862, wherein the U.S. Navy agreed to unload “all negroes, mulattoes, or persons of color, delivered from on board vessels seized in the prosecution of the slave trade.” Yet, despite the two countries’ mutual interests in employing “laborers of African Extraction...

  13. ST–ACTS

    DEFF Research Database (Denmark)

    Gidofalvi, Gyozo; Pedersen, Torben Bach

    2006-01-01

    various geo–statistical data sources and intuitive principles, models the so far neglected aspects. ST–ACTS considers that (1) objects (representing mobile users) move from one spatio–temporal location to another with the objective of performing a certain activity at the latter location; (2) not all users...

  14. Acts of Research

    DEFF Research Database (Denmark)

    Nelund, Sidsel

    described as knowledge producers and exhibitions and art works as instances of knowledge production. Acts of Research: Knowledge Production in Contemporary Arts between Knowledge Economy and Critical Practices analyses this development. The academic discussion of knowledge production in the arts has taken...

  15. The USA PATRIOT Act.

    Science.gov (United States)

    Minow, Mary; Coyle, Karen; Kaufman, Paula

    2002-01-01

    Explains the USA PATRIOT (Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism) Act, passed after the September 11 terrorist attacks, and its implications for libraries and patron records. Considers past dealings with the FBI; court orders; search warrants; wiretaps; and subpoenas. Includes:…

  16. Acting like a Pro

    Science.gov (United States)

    Walker, Marlon A.

    2012-01-01

    The Saturday morning acting class in the Pearson Hall auditorium at Miles College boasts the school's highest attendance all year. The teacher, actress Robin Givens, was a lure few students--and others from surrounding areas--could resist. Some came to learn about their prospective field from a professional. Others were there for pointers to…

  17. A pragmatic cluster randomised trial evaluating three implementation interventions

    Directory of Open Access Journals (Sweden)

    Rycroft-Malone Jo

    2012-08-01

    Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first

  18. GPON FTTH trial: lessons learned

    Science.gov (United States)

    Weis, Erik; Hölzl, Rainer; Breuer, Dirk; Lange, Christoph

    2009-11-01

    This paper reports on a FTTH field trial with GPON (Gigabit-capable passive optical network) technology in the network of Deutsche Telekom in the region of the cities of Berlin and Potsdam. Focus of this trial was to gain practical experience regarding GPON technology, fibre installation in existing ducts with micro duct technology, fibre cabling in customer buildings and impact on operational processes. Furthermore it is reported on an initial Deutsche Telekom FTTB deployment based on GPON technology in the city of Dresden with the main targets to obtain practical deployment and operation experiences with fibre-based access networks and to provide broadband access to a part of the city formerly not servable by DSL (digital subscriber line) technology.

  19. Ethics of clinical trials in Nigeria

    Directory of Open Access Journals (Sweden)

    Patrick I Okonta

    2014-01-01

    Full Text Available The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

  20. Ethics of clinical trials in Nigeria.

    Science.gov (United States)

    Okonta, Patrick I

    2014-05-01

    The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

  1. 76 FR 18226 - Guidance for Industry on Postmarketing Studies and Clinical Trials-Implementation of Section 505...

    Science.gov (United States)

    2011-04-01

    ... Clinical Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.'' The... clinical trials for prescription drugs approved under the FD&C Act and biological products approved under... of the new provisions and a description of the types of postmarketing studies and clinical...

  2. Adubação do milho: IX - Ensaio com lôdo de fossas sépticas "OMS" Fertilizer experiments with corn: IX - Trial with dried sewage sludge

    Directory of Open Access Journals (Sweden)

    G. P. Viégas

    1956-01-01

    was used at the dosages of 2.5, 5 and 10 metric tons to the hectare, either alone or supplementd with phosphorus (bone meal, potassium (coffee beans ash, or both. All the fertilizers were applied only in the first year, 1943-44, but corn was planted in the same plots for three consecutive yars. The yield increase due to phosphorus was small, apparently because the area used for the experiment had been fertilized with phosphates in the previous crops. Potassium increased considerably the yield in the first year and showed excellent residual effect in the two succeeding years. In the absence of potash the sludge product acted poorly, but in the presence of that nutrient its effect increased appreciably. The 5 and 10 tons rates gave satisfactory results; however, they increased comparatively more the production of stover than the grain yield. The nitrogen of the sludge product acts fairly quickly, but apparently little of it remains in the soil for the succeeding crops. For better utilization of its nitrogen, the sludge product should be applied frequently (perhaps annually and at moderate rates, supplemented with potash and phosphate, according to the soil.

  3. Acts of Research

    DEFF Research Database (Denmark)

    Nelund, Sidsel

    The term ‘knowledge society’ is used to refer to the increasing relevance of nonmanual knowledge-producing labour in current post-industrial economies. Contemporary art, especially since 1989, has not been left out of this trend, to the extent that today it is not rare to see artists and curators...... place mostly in seminars and articles, in which knowledge is often discussed as an intrinsic quality of the artwork. Acts of Research, however, is devoted to studying the rise of knowledge production in contemporary art from the perspective of artistic, curatorial and educational research...... described as knowledge producers and exhibitions and art works as instances of knowledge production. Acts of Research: Knowledge Production in Contemporary Arts between Knowledge Economy and Critical Practices analyses this development. The academic discussion of knowledge production in the arts has taken...

  4. RECOGNISING SPEECH ACTS

    Directory of Open Access Journals (Sweden)

    Phyllis Kaburise

    2012-09-01

    Full Text Available Speech Act Theory (SAT, a theory in pragmatics, is an attempt to describe what happens during linguistic interactions. Inherent within SAT is the idea that language forms and intentions are relatively formulaic and that there is a direct correspondence between sentence forms (for example, in terms of structure and lexicon and the function or meaning of an utterance. The contention offered in this paper is that when such a correspondence does not exist, as in indirect speech utterances, this creates challenges for English second language speakers and may result in miscommunication. This arises because indirect speech acts allow speakers to employ various pragmatic devices such as inference, implicature, presuppositions and context clues to transmit their messages. Such devices, operating within the non-literal level of language competence, may pose challenges for ESL learners.

  5. REVOCATION OF ADMINISTRATIVE ACT

    Directory of Open Access Journals (Sweden)

    MARTA CLAUDIA CLIZA

    2012-05-01

    Full Text Available Because the revocation is totally specific for administrative law principles, I chose to talk about in this study and its impact on the cancellation of administrative acts. Revocation will be explored, in terms of the authorities which it may provide but also of the effects caused.It also would examine if revocation has a legal basis, as well as real cases to provide the impact of this principle in administrative law.

  6. Toxic Substances Control Act

    Energy Technology Data Exchange (ETDEWEB)

    1992-05-15

    This Reference Book contains a current copy of the Toxic Substances Control Act and those regulations that implement the statute and appear to be most relevant to DOE activities. The document is provided to DOE and contractor staff for informational purposes only and should not be interpreted as legal guidance. Questions concerning this Reference Book may be directed to Mark Petts, EH-231 (202/586-2609).

  7. Why the act?

    Science.gov (United States)

    Kumta, N B

    1995-07-01

    All of the 4000 infants who die daily in India have been bottle fed. Most of these infants die from infections which are typically caused by bottle feeding. Considerable research has shown that human breast milk ideally suits babies' needs. Human breast milk protects infants from several infections and allergies, such that the breastfed infant is 25 times less likely than the bottle fed infant to die due to diarrhea and pneumonia. Comparative studies have even found breastfed babies to have higher IQs than bottle fed ones. Detrimental maternity home practices, adverse social factors, and the unethical and aggressive marketing strategy adopted by the manufacturers of infant milk substitutes and feeding bottles are the major factors responsible for the erosion of the practice of breastfeeding. These factors are discussed. The Infant Milk Substitutes, Feeding Bottles, and Infant Foods Act prohibits the advertisement and promotion of feeding bottles and infant milk substitutes by unethical marketing strategies. Violations of the act are punishable by imprisonment and a heavy fine. The act and the need for its passage are discussed.

  8. Williamson Act - The California Land Conservation Act of 1965

    Data.gov (United States)

    California Department of Resources — The California Land Conservation Act of 1965 - commonly referred to as the Williamson Act - is the State's primary program for the conservation of private land in...

  9. Informed Consent (Clinical Trials)

    Science.gov (United States)

    ... Research Cancer Treatment Types of Treatment Side Effects Clinical Trials Information A to Z List of Cancer Drugs ... Staging Prognosis Treatment Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings & Cancer ...

  10. Research Areas - Clinical Trials

    Science.gov (United States)

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  11. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Institutes of Health funds much of this basic research. Screening Trials In screening trials, researchers study ways of finding a disease before symptoms occur. These methods, often called screening tests, can include imaging tests ...

  12. ClinicalTrials.gov

    Science.gov (United States)

    ... to This Site Terms and Conditions Disclaimer ClinicalTrials.gov is a registry and results database of publicly ... of human participants conducted around the world. ClinicalTrials.gov is a registry and results database of publicly ...

  13. Adubação do algodoeiro VII: ensaios com diversos adubos fosfatados (1.ª série Fertilizer experiments with cotton VII: trials with various phosphorus fertilizers (1st. .series

    Directory of Open Access Journals (Sweden)

    O. S. Neves

    1959-01-01

    started before 1941, five of which can be utilized to show the effects on the yields. The latter were conducted in the same plots for three or more seasons. The yearly applications of P2O5 varied according to the experiment from 60 to 90 kilograms per hectare and were always used in the presence of nitrogen and potash. The various phosphates tested, including ordinary and granulated superphosphate, precipitated phosphate, Rhenaniaphosphate, Thomas slag, and bone meal, gave practically the same results. The authors warn, however, that the small number of experiments and the conditions under which they were conducted do not as yet permit to draw definite conclusions on the subject. In four trials, which included plots fertilized only with nitrogen and potash, the mean effect of phosphorus on the yield of seed cotton varied from fair to very high. The latter offered an excellent opportunity for verifying the influence of phosphorus on some characteristics of the cotton plant and its fruits. Phosphorus increased also the weight and height of the plants, but not so much as the yield of seed cotton. When the first picking was made early, it was observed that phosphorus hastened the fruiting march. Phosphorus increased the weight of the bolls, but did not practically affect the lint percentage and length. The residual effect of phosphorus was determined in two of the experiments. Although they were conducted on the "terra-roxa-misturada" type of soil, that effect was high and no difference was observed between that of superphosphate and the relatively insoluble phosphates.

  14. Affordable Care Act and Women

    Science.gov (United States)

    ... Outcomes Research Trust Fund (PCORTF) Poverty Poverty Guidelines Poverty Analysis Teen Pregnancy Prevention Homelessness MACRA Publications Data and Tools Evaluation Database The Affordable Care Act and Women 03/20/2012 Home The Affordable Care Act ...

  15. Virtual Acts of Balance!

    DEFF Research Database (Denmark)

    Madsen, Anders Koed

    2013-01-01

    improve 'knowledge-democracy' in different ways. The paper denotes such portals 'virtual technologies of knowledge management' and it uses the documental data as a window to analyze and discuss the infrastructural choices of such portals. The analysis is grounded in theories related to 'Social....... It is especially emphasized how technical web-ontologies implicitly carries with them deeper philosophical ontologies about phanomena such as 'politic', 'scientific intentionality' and 'freedom'. The compromise between these technical influences and the social intentions is described as a 'virtual act of balance...

  16. The Act of Walking

    DEFF Research Database (Denmark)

    Vestergaard, Maria Quvang Harck; Olesen, Mette; Helmer, Pernille Falborg

    2014-01-01

    ’ of mobility (Jensen 2013:111) such as the urban environment, and the infrastructures. Walking has indeed also a ‘software dimension’ as an embodied performance that trigger the human senses (Jensen 2013) and which is closely related to the habitus and identity of the individual (Halprin 1963). The individual...... the individuals evaluate, interpret and act (Bourdieu 1984), and how this affects their choice to walk. Therefore it could be questioned if whether an assessment of the physical environment is sufficient to identify all the factors that influence the individual perception of ‘walkability’, or if other influencing...

  17. Differences in trial knowledge and motives for participation among cancer patients in phase 3 clinical trials.

    Science.gov (United States)

    Godskesen, T M; Kihlbom, U; Nordin, K; Silén, M; Nygren, P

    2016-05-01

    While participants in clinical oncology trials are essential for the advancement of cancer therapies, factors decisive for patient participation have been described but need further investigation, particularly in the case of phase 3 studies. The aim of this study was to investigate differences in trial knowledge and motives for participation in phase 3 clinical cancer trials in relation to gender, age, education levels and former trial experience. The results of a questionnaire returned from 88 of 96 patients (92%) were analysed using the Mann-Whitney U-test. There were small, barely relevant differences in trial knowledge among patients when stratified by gender, age or education. Participants with former trial experience were less aware about the right to withdraw. Male participants and those aged ≥65 years were significantly more motivated by a feeling of duty, or by the opinions of close ones. Men seem more motivated than women by external factors. With the awareness that elderly and single male participants might be a vulnerable group and participants with former trial experience are less likely to be sufficiently informed, the information consent process should focus more on these patients. We conclude that the informed consent process seems to work well, with good results within most subgroups.

  18. Understanding noninferiority trials

    Directory of Open Access Journals (Sweden)

    Seokyung Hahn

    2012-11-01

    Full Text Available Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.

  19. Experiments in computing: a survey.

    Science.gov (United States)

    Tedre, Matti; Moisseinen, Nella

    2014-01-01

    Experiments play a central role in science. The role of experiments in computing is, however, unclear. Questions about the relevance of experiments in computing attracted little attention until the 1980s. As the discipline then saw a push towards experimental computer science, a variety of technically, theoretically, and empirically oriented views on experiments emerged. As a consequence of those debates, today's computing fields use experiments and experiment terminology in a variety of ways. This paper analyzes experimentation debates in computing. It presents five ways in which debaters have conceptualized experiments in computing: feasibility experiment, trial experiment, field experiment, comparison experiment, and controlled experiment. This paper has three aims: to clarify experiment terminology in computing; to contribute to disciplinary self-understanding of computing; and, due to computing's centrality in other fields, to promote understanding of experiments in modern science in general.

  20. FCC and the Sunshine Act.

    Science.gov (United States)

    Weiss, Kenneth

    The Sunshine Act, designed to encourage open meetings to increase public understanding of the governmental decision-making process, went into effect in March 1977. A total of 50 agencies, including the Federal Communications Commission (FCC), are subject to the provisions of the Sunshine Act. The act lists 10 exemptions, any of which can result in…

  1. of the Intestate Succession Act

    African Journals Online (AJOL)

    10332324

    substitution in terms of the Intestate Succession Act 81 of 1987. See the ... the Court explained the reasons for the difference between its .... (b) Each surviving spouse should inherit a child's share of the intestate estate or so ... the Black Administration Act 38 of 1927 and the Births and Deaths Registration Act 51 of 1992. 36.

  2. Acting Antarctica: science on stage

    Science.gov (United States)

    Ciceri, Piera; Tizzoni, Paola; Pierro, Luigia

    2016-04-01

    Key-words: Polar science, Earth science, Theatre, Hands on activities The legendary Antarctic Expedition of sir E. Shackleton and his crew of 27 aboard the Endurance (1914/16) trapped in the Antarctic ice has become the starting point to learn about Polar Science and Climate Change. While the students were involved into this incredible adventure by the astonishing images of the Australian photographer Frank Hurley (who joined the crew), they discovered the world in which this story happened. Students were then involved in hands-on activities and role plays and have become the writers of the play "Uomini a scienza ai confini del mondo". They act the story of Shackelton's expedition and they tell at the same time to the audience about ice pack, ice cores and their role in understanding the past of the climate, physical and geographical characteristic of polar regions, thermal phenomena related to adaptations of polar animals, solar radiation at different latitude, day/night duration. The theater was the place to "stage" some scientific experiments and to explain the current research carried out in polar regions and their importance in climate change studies and to stress some similarities between Antarctica and space. The project was carried out from teachers of science, letters and geography and was born in collaboration with the "Piccolo Teatro di Milano" and the association "Science Under 18" with the support of a professional actor and director and was played for other schools at "EXPO 2015" in Milano (Italy). In our opinion drama activities improve reading comprehension, and both verbal and non-verbal communication skills. To be able to write and to act, students need a deep understanding of contents. Arts, including theatre, are a good key to involve emotionally students. To have an audience different from their own teachers and classmates offers a real task and the opportunity to play and let grow real skills.

  3. Compliance with results reporting at ClinicalTrials.gov.

    Science.gov (United States)

    Anderson, Monique L; Chiswell, Karen; Peterson, Eric D; Tasneem, Asba; Topping, James; Califf, Robert M

    2015-03-12

    The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results. Using an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated with reporting at 12 months and throughout the 5-year study period. From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions. Despite ethical and legal obligations to disclose findings promptly, most HLACTs did not report results to ClinicalTrials.gov in a timely fashion during the study period. Industry-funded trials adhered to legal obligations more often than did trials funded by the NIH or other government or academic

  4. A CLASS ACT

    National Research Council Canada - National Science Library

    Janelle B Mathis

    2005-01-01

      Another dinner exchange might concern modern-day childhood and its responsibilities and include characters and individuals from past-eras and different cultures to discuss their experiences and to lend perspective...

  5. Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

    Science.gov (United States)

    2013-01-01

    Background Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Methods Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). Results The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. Conclusions We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials. PMID:23433341

  6. Experience about causality assessment of fibrinogen in phase Ⅰ clinical trial of Chinese herbal medicine%中药新药Ⅰ期临床试验中纤维蛋白原关联性判断的体会

    Institute of Scientific and Technical Information of China (English)

    鲁喦; 李涛; 贾增芹; 高蕊; 唐旭东

    2012-01-01

    目的:探讨Ⅰ期临床试验中纤维蛋白原指标评价存在的问题及其解决办法.方法:通过一个新药Ⅰ期临床试验案例对受试者的纤维蛋白原检测结果进行分析.结果:单次给药试验的30例受试者中,26例出现纤维蛋白原降低,但无量效关系;在随后的连续给药试验中加入安慰剂对照组,其结果纤维蛋白原在高低剂量组中无量效关系,试验药物组和安慰剂对照组纤维蛋白原出现一致性变化,证实纤维蛋白原的变化与试验药物无关.结论:纤维蛋白原检测受到多种因素的影响,应规范操作过程减少对其的影响;应制定适当的检测指标纳入标准;必要时可增加安慰剂对照,采用多种手段对实验室不良事件的关联性进行综合判断.%AIM: To explore the fibrinogen e-valuation problems and solution in phase I clinical trials. METHODS: Through a new phase I trial,there were 54 cases in phase I clinical trial volunteers' fibrinogen test, and analysised the results. RESULTS:Fibrinogen change did not exist consistency , between 30 cases in single dose trial,there were 26 cases fibrinogen reduced ; In subsequent continuous drug trials to join the comfort drug group, the results of the two groups still did not exist consistency between groups, trial drug and placebo group fibrinogen appear consistency changes , confirm the changesof fibrinogen is none of test drug. CONCLUSION: Fibrinogen test is affected by many kinds of factors, should be standardized operation process to reduce the influence; identify proper testing index range and inclusion criteria; can install placebo group if necessary, using a variety of means for causality assessment of the laboratory adverse events.

  7. Antigravity Acts on Photons

    Science.gov (United States)

    Brynjolfsson, Ari

    2002-04-01

    Einstein's general theory of relativity assumes that photons don't change frequency as they move from Sun to Earth. This assumption is correct in classical physics. All experiments proving the general relativity are in the domain of classical physics. This include the tests by Pound et al. of the gravitational redshift of 14.4 keV photons; the rocket experiments by Vessot et al.; the Galileo solar redshift experiments by Krisher et al.; the gravitational deflection of light experiments by Riveros and Vucetich; and delay of echoes of radar signals passing close to Sun as observed by Shapiro et al. Bohr's correspondence principle assures that quantum mechanical theory of general relativity agrees with Einstein's classical theory when frequency and gravitational field gradient approach zero, or when photons cannot interact with the gravitational field. When we treat photons as quantum mechanical particles; we find that gravitational force on photons is reversed (antigravity). This modified theory contradicts the equivalence principle, but is consistent with all experiments. Solar lines and distant stars are redshifted in accordance with author's plasma redshift theory. These changes result in a beautiful consistent cosmology.

  8. Minority Representation in Migraine Treatment Trials.

    Science.gov (United States)

    Robbins, Nathaniel M; Bernat, James L

    2017-03-01

    Minorities have historically been underrepresented in clinical research trials despite having comparatively poor health indicators. Recognizing the dual inequalities of increased disease burden and decreased research participation, the National Institute of Health (NIH) Revitalization Act of 1993 mandated the inclusion and reporting of women and minorities in NIH-funded research. While progress has been made in the subsequent decades, this underrepresentation of minorities in research trials persists and has been documented in multiple disciplines. However, the extent of adequate representation and reporting of minority inclusion in clinical trials for migraine remains unknown. In this systematic review and study, we review the literature examining the representation of women and minorities in migraine clinical research trials METHODS: First we searched PubMed for pertinent articles examining the inclusion of women and minorities in migraine clinical research trials. Second, we identified controlled-trials for migraine published since 2011 in major neurology, headache, and general medicine journals using the terms "migraine randomized controlled trial." We then reviewed the results manually and excluded pilot studies and those with fewer than 50 participants. We next determined (a) how frequently representation of minorities and women were reported in these major trials; (b) what factors correlated with reporting; and (c) whether women and minority inclusion comprised their ratios in the general population. We identified 128 relevant clinical trials, of which 36 met our inclusion criteria. All 36 trials (100%) reported gender frequency, and 25 of 36 (69.4%) reported ethnicity or race. Among all studies, women and Whites represented 84.2 and 82.9% of participants (mean), respectively. Studies conducted in the United States and funded by a private company were more likely to report race than studies conducted exclusively outside of the U.S. or with a public sponsor

  9. A Balancing Act?

    DEFF Research Database (Denmark)

    Gerstlberger, Wolfgang; Knudsen, Mette Præst; Stampe, Ian

    efficiency moderates the effect of market attention on new product development. The paper therefore concludes that product innovation and energy efficiency is a balancing act, focusing on one will have detrimental effects on the other! These findings point to the conclusion that researchers and practitioners...... the 2009 European Manufacturing Survey for the Danish sub-sample including 335 manufacturing firms. Through factor analysis, the paper confirms three main focus areas of new product development in relation to production facilities: efficiency considerations, market attention and greening of innovation....... Logistic regression analysis demonstrates that while market attention is important for new product development, green aspects of innovation and efficiency considerations for innovation are important for the energy efficiency of the production companies. Combining these models highlights that energy...

  10. Long-acting beta(2)-agonists in management of childhood asthma

    DEFF Research Database (Denmark)

    Bisgaard, H

    2000-01-01

    This review assesses the evidence regarding the use of long-acting beta(2)-agonists in the management of pediatric asthma. Thirty double-blind, randomized, controlled trials on the effects of formoterol and salmeterol on lung function in asthmatic children were identified. Single doses of inhaled......, long-acting beta(2)-agonists provide effective bronchodilatation and bronchoprotection when used as intermittent, single-dose treatment of asthma in children, but not when used as regular treatment. Future studies should examine the positioning of long-acting beta(2)-agonists as an "as needed" rescue...... medication instead of short-acting beta(2)-agonists for pediatric asthma management....

  11. Exploring how different modes of governance act across health system levels to influence primary healthcare facility managers' use of information in decision-making: experience from Cape Town, South Africa.

    Science.gov (United States)

    Scott, Vera; Gilson, Lucy

    2017-09-15

    Governance, which includes decision-making at all levels of the health system, and information have been identified as key, interacting levers of health system strengthening. However there is an extensive literature detailing the challenges of supporting health managers to use formal information from health information systems (HISs) in their decision-making. While health information needs differ across levels of the health system there has been surprisingly little empirical work considering what information is actually used by primary healthcare facility managers in managing, and making decisions about, service delivery. This paper, therefore, specifically examines experience from Cape Town, South Africa, asking the question: How is primary healthcare facility managers' use of information for decision-making influenced by governance across levels of the health system? The research is novel in that it both explores what information these facility managers actually use in decision-making, and considers how wider governance processes influence this information use. An academic researcher and four facility managers worked as co-researchers in a multi-case study in which three areas of management were served as the cases. There were iterative cycles of data collection and collaborative analysis with individual and peer reflective learning over a period of three years. Central governance shaped what information and knowledge was valued - and, therefore, generated and used at lower system levels. The central level valued formal health information generated in the district-based HIS which therefore attracted management attention across the levels of the health system in terms of design, funding and implementation. This information was useful in the top-down practices of planning and management of the public health system. However, in facilities at the frontline of service delivery, there was a strong requirement for local, disaggregated information and experiential

  12. Interactive Approach on Experiments in Mechanical Engineering : Vibration

    Science.gov (United States)

    Kumon, Makoto; Torigoe, Ippei; Mizumoto, Ikuro; Yamaguchi, Teruo; Kohzawa, Ryuichi; Ohshima, Yasutaka

    Experiments in the engineering education play important roles in motivating students to study voluntarily. A trial aiming to enhance this effect in the experiment of vibration at Mechanical System Engineering, Kumamoto University is introduced. The trial consists of 1) oral presentation by students, 2) web-based learning system and 3) feedback through reports. An evaluation by questionnaire was conducted to show the validity of this trial. This result revealed that the trial succeeded to encourage students.

  13. Hamlet and psychoanalytic experience.

    Science.gov (United States)

    Schwaber, Paul

    2007-01-01

    Hamlet draws us into its rendered world, enabling us to experience it with depth, awareness, and resonance, in a mode we recognize as aesthetic. By way of Shakespeare's play--primarily the first act--and a detailed case study, aesthetic and psychoanalytic experience are compared, to suggest that, for our own analytic discourse, we revalue Freud's unease that his case studies read like short stories.

  14. The COLOFOL trial

    DEFF Research Database (Denmark)

    Hansdotter Andersson, Pernilla; Wille-Jørgensen, Peer; Horváth-Puhó, Erzsébet

    2016-01-01

    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...

  15. Empowering natural clinical trial advocates: nurses and outreach workers.

    Science.gov (United States)

    Mitschke, Diane B; Cassel, Kevin; Higuchi, Paula

    2007-03-01

    Cancer clinical trials are essential to advancing the prevention and treatment of cancer, yet adult participation rates in clinical trials remain abysmal. Despite the essential contributions of clinical trials to science and medicine, adult participation in clinical trials remains exceedingly low, with only 2%-4% of all adult patients with cancer in the U.S. participating in clinical trials. Clinical trials accrual rates in Hawai'i follow this national trend of less than 3% of eligible patients participating in trials. Recognizing the need to increase awareness about clinical trials, the National Cancer Institute's Cancer Information Service-Pacific Region, through the Hawai'i Clinical Trials Education Coalition, has employed strategic dissemination plans to train and educate key target audiences, including registered nurses, nursing students, and community outreach workers about the availability of over 90 cancer clinical trials in Hawai'i. Previous research suggests that nurses often play a vital role in increasing a patient's understanding of clinical trials and may also act as a patient advocate in regards to participation in a clinical trial. A train-the-trainer model curriculum was developed using the Clinical Trials Education Series (CTES), a collection of multi-level resources designed by the National Cancer Institute, to educate various constituents about clinical trials. The training curriculum and workshop format is adapted based on both formal and informal needs assessments conducted with audiences prior to the planned training, yet key elements remain central to the training model. In addition, an interactive, internet-based case study was developed using local place names and cultural cues to allow training participants to engage in realistic and practical methods for locating and sharing information about clinical trials with patients and the public. This training model has been implemented in a variety of settings including three statewide nursing

  16. Juvenile Competency to Stand Trial.

    Science.gov (United States)

    Stepanyan, Sofia T; Sidhu, Shawn S; Bath, Eraka

    2016-01-01

    Competency to stand trial is interpreted as a protected due process right for all defendants and is defined as a defendant's fundamental knowledge and understanding of the criminal charges being filed, roles and procedures within the courtroom, and a general ability to work with the defense counsel. Questions of competency are most often raised by the judge, defense, or the prosecution, and competency evaluations are most often completed by psychiatrists or psychologists with forensic training or work experience. Mental illness, intellectual disability, developmental disorders, and developmental immaturity are the 4 main factors considered in most juvenile competency evaluations.

  17. Resource utilization implications of treatment were able to be assessed from appropriately reported clinical trial data

    NARCIS (Netherlands)

    Poole-Wilson, Philip A.; Kirwan, Bridget-Anne; Voko, Zoltan; de Brouwer, Sophie; Dunselman, Peter H. J. M.; van Dalen, Frederik J.; Lubsen, Jacobus

    2007-01-01

    Background and Objective: Published clinical trial data rarely allow assessment of the health care resource utilization implications of treatment. We give an example of how these can be assessed given appropriate tabulation of data. Methods: Data from a trial comparing long-acting nifedipine gastroi

  18. Acceptance and Commitment Therapy (ACT) for Chronic Pain: A Systematic Review and Meta-Analyses.

    Science.gov (United States)

    Hughes, Laura S; Clark, Jodi; Colclough, Janette A; Dale, Elizabeth; McMillan, Dean

    2017-06-01

    Chronic pain places a burden on individuals and the economy. Although there is evidence for the effectiveness of cognitive-behavior therapy, it is recognized that the effects are limited. Acceptance and Commitment Therapy (ACT), which aims to increase valued action in the presence of pain, has been suggested as an alternative approach. The objective of this review was to determine the clinical effectiveness of ACT for chronic pain in adults when compared with control conditions and other active treatments. The searches of this systematic review were conducted in the Cochrane library, MEDLINE, EMBASE, CINAHL Plus (EBSCO), and PsycINFO. Grey literature, reference list, and reverse citation searches were also completed. Eleven trials were included. ACT was favored over controls (no alternative intervention or treatment as usual). Significant, medium to large effect sizes were found for measures of pain acceptance and psychological flexibility, which are typically considered processes of ACT. Significant small to medium effect sizes were found for measures of functioning, anxiety, and depression. Measures of pain intensity and quality of life were not significantly different than zero. Generally effect sizes were smaller at follow-up. ACT was more clinically effective than controls on a number of outcomes. It is possible that methodological limitations, some of which are common to psychological trials, may have led to overestimated effects. Only a few studies compared ACT to active treatments and while the evidence is promising for ACT in the treatment of chronic pain, further methodologically robust trials are required.

  19. An Act of Colonization

    DEFF Research Database (Denmark)

    Rasmussen, Anders Bo

    When Gideon Welles, U.S. Secretary of the Navy, sat down to write his diary entry on September 26, 1862, his thoughts turned once more to colonization. President Lincoln was an ardent proponent of colonization, “the government-promoted settlement of black Americans in Africa or some other location......” and based on the recurring cabinet discussions, Welles understood that “Great Britain, Denmark and perhaps other powers would take them [the black population].” Since at least 1860, Denmark had encouraged the American government to send the “quite uncivilized (…) Africans liberated” from slave ships to St...... and the United States signed an act on July 19, 1862, wherein the U.S. Navy agreed to unload “all negroes, mulattoes, or persons of color, delivered from on board vessels seized in the prosecution of the slave trade.” Yet, despite the two countries’ mutual interests in employing “laborers of African Extraction...

  20. Double acting bit holder

    Science.gov (United States)

    Morrell, Roger J.; Larson, David A.; Ruzzi, Peter L.

    1994-01-01

    A double acting bit holder that permits bits held in it to be resharpened during cutting action to increase energy efficiency by reducing the amount of small chips produced. The holder consist of: a stationary base portion capable of being fixed to a cutter head of an excavation machine and having an integral extension therefrom with a bore hole therethrough to accommodate a pin shaft; a movable portion coextensive with the base having a pin shaft integrally extending therefrom that is insertable in the bore hole of the base member to permit the moveable portion to rotate about the axis of the pin shaft; a recess in the movable portion of the holder to accommodate a shank of a bit; and a biased spring disposed in adjoining openings in the base and moveable portions of the holder to permit the moveable portion to pivot around the pin shaft during cutting action of a bit fixed in a turret to allow front, mid and back positions of the bit during cutting to lessen creation of small chip amounts and resharpen the bit during excavation use.

  1. Conditional advice and inducements: are readers sensitive to implicit speech acts during comprehension?

    Science.gov (United States)

    Haigh, Matthew; Stewart, Andrew J; Wood, Jeffrey S; Connell, Louise

    2011-03-01

    Conditionals can implicitly convey a range of speech acts including promises, tips, threats and warnings. These are traditionally divided into the broader categories of advice (tips and warnings) and inducements (promises and threats). One consequence of this distinction is that speech acts from within the same category should be harder to differentiate than those from different categories. We examined this in two self-paced reading experiments. Experiment 1 revealed a rapid processing penalty when inducements (promises) and advice (tips) were anaphorically referenced using a mismatching speech act. In Experiment 2 a delayed penalty was observed when a speech act (promise or threat) was referenced by a mismatching speech act from the same category of inducements. This suggests that speech acts from the same category are harder to discriminate than those from different categories. Our findings not only support a semantic distinction between speech act categories, but also reveal pragmatic differences within categories. Copyright © 2011 Elsevier B.V. All rights reserved.

  2. Advanced Communications Technology Satellite (ACTS)

    Science.gov (United States)

    Olmstead, Dean A.; Schertler, Ronald J.

    The benefits that will be offered by the NASA-sponsored communication spacecraft ACTS which is scheduled for launch in 1992 are described together with examples of demonstrations on proposed data, video, and voice applications supported by the advanced ACTS technologies. Compared to existing satellite service, the ACTS will provide lower cost, better service, greater convenience, and improved service reliability of telecommunications to customers around the world. In addition, the pioneering ACTS technology will provide many capabilities qualitatively different from those of current satellite systems, such as on-demand assignment, frequency reuse, and the flexible targeting of spot beams directly to the very-small-aperture terminals at customer premises.

  3. Clinical Trials in Noninfectious Uveitis

    Science.gov (United States)

    Kim, Jane S.; Knickelbein, Jared E.; Nussenblatt, Robert B.; Sen, H. Nida

    2015-01-01

    The treatment of noninfectious uveitis continues to remain a challenge for many ophthalmologists. Historically, clinical trials in uveitis have been sparse, and thus, most treatment decisions have largely been based on clinical experience and consensus guidelines. The current treatment paradigm favors initiation then tapering of corticosteroids with addition of steroid-sparing immunosuppressive agents for persistence or recurrence of disease. Unfortunately, in spite of a multitude of highly unfavorable systemic effects, corticosteroids are still regarded as the mainstay of treatment for many patients with chronic and refractory noninfectious uveitis. However, with the success of other conventional and biologic immunomodulatory agents in treating systemic inflammatory and autoimmune conditions, interest in targeted treatment strategies for uveitis has been renewed. Multiple clinical trials on steroid-sparing immunosuppressive agents, biologic agents, intraocular corticosteroid implants, and topical ophthalmic solutions have already been completed, and many more are ongoing. This review discusses the results and implications of these clinical trials investigating both alternative and novel treatment options for noninfectious uveitis. PMID:26035763

  4. TBCS/Chameleon Utility Trial Report

    Science.gov (United States)

    2005-05-01

    mission contexts, different mission tasks, different time pressures and different team roles . For example, the levels of detail to support planning before...predictive value of the results. • the low level of experience in the personnel who played combat team roles in the trial • a single participant at each

  5. Unit: Petroleum, Inspection Pack, National Trial Print.

    Science.gov (United States)

    Australian Science Education Project, Toorak, Victoria.

    This is a National Trial Print of a unit on petroleum developed for the Australian Science Education Project. The package contains the teacher's edition of the written material and a script for a film entitled "The Extraordinary Experience of Nicholas Nodwell" emphasizing the uses of petroleum and petroleum products in daily life and…

  6. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial

    DEFF Research Database (Denmark)

    Madsbad, Sten; Schmitz, Ole; Ranstam, Jonas;

    2004-01-01

    OBJECTIVE: Liraglutide is a long-acting glucagon-like peptide 1 analog designed for once daily injection. This study assessed the efficacy and safety of liraglutide after 12 weeks of treatment in type 2 diabetic patients. RESEARCH DESIGN AND METHODS: A double-blind, randomized, parallel...

  7. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial

    DEFF Research Database (Denmark)

    Madsbad, Sten; Schmitz, Ole; Ranstam, Jonas

    2004-01-01

    OBJECTIVE: Liraglutide is a long-acting glucagon-like peptide 1 analog designed for once daily injection. This study assessed the efficacy and safety of liraglutide after 12 weeks of treatment in type 2 diabetic patients. RESEARCH DESIGN AND METHODS: A double-blind, randomized, parallel...

  8. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... disease or prevent a disease from returning. Supportive Care Trials In supportive care trials, researchers look for ways to make life ... groups, and various types of social interventions. Supportive care interventions are not intended to treat or cure ...

  9. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...

  10. Evil acts not evil people: their characteristics and contexts.

    Science.gov (United States)

    Horne, Michael

    2008-11-01

    The problem of evil has vexed philosophers and theologians for centuries and anthropologists, sociologists, psychoanalysts and analytical psychologists in more recent times. Numerous theories have been proposed but there is still little agreement on such basic questions as the nature of evil, what constitutes and motivates an evil act, and how we resolve conflicts between individuals and groups in which evil acts are being committed. I am proposing that evil should be used as an adjective, and not as a noun. As such it should be employed to qualify acts of persons rather than their character. This change would enable us to eschew foundational explanations of evil and, therefore, to examine evil acts in their contexts and so better discern their nature and motivation. I will contend that evil acts begin when an individual makes, or members of a group make, assertions about the 'naturalness' of their own acts and, correspondingly, the 'unnaturalness' of the acts of others. I will suggest that this results from the anxiety that ensues when they cannot adequately signify their experience of these acts. When this occurs, those so treated are dispossessed of their 'personhood', allowing members of the 'natural' group to violate their 'boundaries' with impunity. These violations can range from the relatively innocuous such as being ignored to the extreme such as genocide. I am asserting that all these acts should be termed evil as they derive from the same semiotic process of 'naturalizaton'. I will discuss ways of preventing individuals or groups from embarking on the process of 'naturalization' and describe the types of contexts that might reduce or eliminate the commission of evil acts by those already engaged in their perpetration. To demonstrate these ideas I will use examples from my personal experience, from analytic theory and from the 'troubles' in Northern Ireland.

  11. [Euthanasia and medical act].

    Science.gov (United States)

    2011-05-01

    Right to life -as the prohibition of intentionally and arbitrarily taking life, even with authorization of the concerned one- is an internationally recognized right. In many countries, debate regarding euthanasia is more centered in its convenience, social acceptability and how it is regulated, than in its substantial legitimacy. Some argue that euthanasia should be included as part of clinical practice of health professionals, grounded on individual's autonomy claims-everyone having the liberty to choose how to live and how to die. Against this, others sustain that life has a higher value than autonomy, exercising autonomy without respecting the right to life would become a serious moral and social problem. Likewise, euthanasia supporters some-times claim a 'right to live with dignity', which must be understood as a personal obligation, referred more to the ethical than to the strictly legal sphere. In countries where it is already legalized, euthanasia practice has extended to cases where it is not the patient who requests this but the family or some healthcare professional, or even the legal system-when they think that the patient is living in a condition which is not worthy to live. Generalization of euthanasia possibly will end in affecting those who need more care, such as elder, chronically ill or dying people, damaging severely personal basic rights. Nature, purpose and tradition of medicine rule out the practice of euthanasia, which ought not be considered a medical act or legitimately compulsory for physicians. Today's medicine counts with effective treatments for pain and suffering, such as palliative care, including sedative therapy, which best preserves persons dignity and keeps safe the ethos of the medical profession.

  12. Trial-by-trial identification of categorization strategy using iterative decision-bound modeling.

    Science.gov (United States)

    Hélie, Sébastien; Turner, Benjamin O; Crossley, Matthew J; Ell, Shawn W; Ashby, F Gregory

    2016-08-05

    Identifying the strategy that participants use in laboratory experiments is crucial in interpreting the results of behavioral experiments. This article introduces a new modeling procedure called iterative decision-bound modeling (iDBM), which iteratively fits decision-bound models to the trial-by-trial responses generated from single participants in perceptual categorization experiments. The goals of iDBM are to identify: (1) all response strategies used by a participant, (2) changes in response strategy, and (3) the trial number at which each change occurs. The new method is validated by testing its ability to identify the response strategies used in noisy simulated data. The benchmark simulation results show that iDBM is able to detect and identify strategy switches during an experiment and accurately estimate the trial number at which the strategy change occurs in low to moderate noise conditions. The new method is then used to reanalyze data from Ell and Ashby (2006). Applying iDBM revealed that increasing category overlap in an information-integration category learning task increased the proportion of participants who abandoned explicit rules, and reduced the number of training trials needed to abandon rules in favor of a procedural strategy. Finally, we discuss new research questions made possible through iDBM.

  13. 78 FR 73466 - Privacy Act

    Science.gov (United States)

    2013-12-06

    ... CORPORATION 22 CFR Part 707 Privacy Act AGENCY: Overseas Private Investment Corporation. ACTION: Notice of... (``OPIC'') Privacy Act (``PA'') regulations by making substantive and administrative changes. These... procedure, Privacy. For the reasons stated in the preamble the Overseas Private Investment Corporation...

  14. Biomass Program Recovery Act Factsheet

    Energy Technology Data Exchange (ETDEWEB)

    None

    2010-03-01

    The Biomass Program has awarded about $718 million in American Recovery and Reinvestment Act (Recovery Act) funds. The projects the Program is supporting are intended to: Accelerate advanced biofuels research, development, and demonstration; Speed the deployment and commercialization of advanced biofuels and bioproducts; Further the U.S. bioindustry through market transformation and creating or saving a range of jobs.

  15. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Trials Insurance Coverage and Clinical Trials How to Work With Your Health Insurance Plan Federal Government Programs Patient Safety Informed Consent Children's Assent Scientific Review Ending Trials Early Deciding to Take Part ...

  16. Humans apart from nature? Wilderness experience and the Wilderness Act

    Science.gov (United States)

    Mark Fincher

    2012-01-01

    Wilderness managers are faced with making judgments about the appropriateness of different types of recreational activities. One of the criteria they use is wilderness dependence-the notion that an activity should be allowed, or privileged if rationing is required, if it depends on a wilderness setting for much of its value. Inherent in this concept is the idea that...

  17. Evaluation acting: the experience of a public research institute

    Energy Technology Data Exchange (ETDEWEB)

    Guimaraes, Regia Ruth Ramirez; Ferreira, Hudson Rubio; Filgueiras, Sergio A. Cunha [Centro de Desenvolvimento da Tecnologia Nuclear (CDTN/CNEN-MG), Belo Horizonte, MG (Brazil). Planejamento Estrategico e Qualidade - PE]. E-mail: rrg@cdtn.br; hrf@cdtn.br; sacf@cdtn.br

    2007-07-01

    Innovation and knowledge management are central questions of the modern world economy where the incorporation of new knowledge is determining for competition. In this context, there is a movement of pression under public research institutions for a more dynamic participation on the local innovation system. The institutions of C and T should prepare to help the companies to insert in the context of open economies and also to compete in the global market. The modernity requires flexibility and organizational changes in the research institutions. Redefinitions of their practices in relation to other aspects such as: financing sources; partnership with other organizations; definition and planning of the objectives; evaluation, diffusion and valorization of the results and the establishing of a measuring system and performance indicators. Aiming at having an effective institutional insertion on the national and regional systems of innovation, the Nuclear Technology Development Center - CDTN reformulated its strategical planning, incorporating the view of the researchers of the Center and external experts. As part of the evaluation process, CDTN organizes an annual seminar for evaluating its projects, focused on presenting the results and also on the analysis of the performance indicators. The result of this pairs review are widely informed to the Institution and is an important tool for the critical analysis of the institutional performance and for corrections to be made by the high direction. This paper presents the methodology for evaluating the results, as well as the difficulties and improvements incorporated to the process, which has been applied for three years. (author)

  18. Research progress in the development of direct acting antiviral agents for hepatitis C and the anti-viral resistance

    Directory of Open Access Journals (Sweden)

    Song YANG

    2011-05-01

    Full Text Available Recently,directly acting antiviral agents against hepatitic C virus with different mechanisms have been developed and put into clinical trials.Especially,results of phase Ⅲ clinical trials of Boceprevir and Telaprevir have been published,and these two agents are to be approved for marketing in recent years.Also much attention has been paid on anti-viral resistance against direct acting antiviral agents.Great progresses have been made in field of direct acting antiviral agents against hepatitic C virus.Domestic studies in this area should take characteristics of virus and host of Chinese chronic hepatitis C into consideration.

  19. AAB and ABA Renewal as a Function of the Number of Extinction Trials in Conditioned Taste Aversion

    Science.gov (United States)

    Rosas, Juan M.; Garcia-Gutierrez, Ana; Callejas-Aguilera, Jose E.

    2007-01-01

    Three experiments explored renewal in conditioned taste aversion after different amounts of extinction. In Experiment 1, three groups of rats received a single conditioning trial where a saccharin solution was paired with LiCl, followed by 3 extinction trials, and a two-trial test. Groups differed in the context where they received each of the…

  20. Using Acceptance and Commitment Therapy to Increase Self-Compassion: A Randomized Controlled Trial

    OpenAIRE

    Yadavaia, James E.; Hayes, Steven C.; Vilardaga, Roger

    2014-01-01

    Self-compassion has been shown to be related to several types of psychopathology, including traumatic stress, and has been shown to improve in response to various kinds of interventions. Current conceptualizations of self-compassion fit well with the psychological flexibility model, which underlies acceptance and commitment therapy (ACT). However, there has been no research on ACT interventions specifically aimed at self-compassion. This randomized trial therefore compared a 6-hour ACT-based ...

  1. Prehypertension - Time to Act

    Directory of Open Access Journals (Sweden)

    Preeti Gupta

    2012-01-01

    Full Text Available The term "prehypertension" defined as systolic blood pressure between 120 and 139 mmHg and/or diastolic pressures between 80 and 89 mmHg has now gained general acceptance. Prehypertension is associated with ~3-fold greater likelihood of developing hypertension, and roughly twice the number of cardiovascular events, than BP < 120/80 mmHg. When compared with normotensive individuals, prehypertensive individuals are more likely to be overweight and obese, to have other cardiovascular risk factors, to progress to established hypertension, and to experience premature clinical cardiovascular disease. The major unresolved issue is the appropriate manage-ment of such patients. Lifestyle modification is recommended for all patients with prehypertension as it effectively reduces rate of cardiovascular events. Presently pharmacological therapy is indicated for some patients with prehypertension who have specific comorbidities, including diabetes mellitus, chronic kidney disease, and coronary artery disease.

  2. Understanding the impact of subsidizing artemisinin-based combination therapies (ACTs in the retail sector--results from focus group discussions in rural Kenya.

    Directory of Open Access Journals (Sweden)

    Sarah V Kedenge

    Full Text Available BACKGROUND: There is considerable interest in the potential of private sector subsidies to increase availability and affordability of artemisinin-based combination therapies (ACTs for malaria treatment. A cluster randomized trial of such subsidies was conducted in 3 districts in Kenya, comprising provision of subsidized packs of paediatric ACT to retail outlets, training of retail staff, and community awareness activities. The results demonstrated a substantial increase in ACT availability and coverage, though patient counselling and adherence were suboptimal. We conducted a qualitative study in order to understand why these successes and limitations occurred. METHODOLOGY/PRINCIPAL FINDINGS: Eighteen focus group discussions were conducted, 9 with retailers and 9 with caregivers, to document experiences with the intervention. Respondents were positive about intervention components, praising the focused retailer training, affordable pricing, strong promotional activities, dispensing job aids, and consumer friendly packaging, which are likely to have contributed to the positive access and coverage outcomes observed. However, many retailers still did not stock ACT, due to insufficient supplies, lack of capital and staff turnover. Advice to caregivers was poor due to insufficient time, and poor recall of instructions. Adherence by caregivers to dosing guidelines was sub-optimal, because of a wish to save tablets for other episodes, doses being required at night, stopping treatment when the child felt better, and the number and bitter taste of the tablets. Caregivers used a number of strategies to obtain paediatric ACT for older age groups. CONCLUSIONS/SIGNIFICANCE: This study has highlighted that important components of a successful ACT subsidy intervention are regular retailer training, affordable pricing, a reliable supply chain and community mobilization emphasizing patient adherence and when to seek further care.

  3. [Multi-national clinical trial in circulatory disorders].

    Science.gov (United States)

    Takahashi, Kihito

    2009-02-01

    As Japan becomes more integrated into the global market, pharmaceutical research and development (R&D) in Japan faces considerable challenges. While global simultaneous development including Asian countries has become a common strategy for multi-national pharmaceutical companies, Japan has been frequently set aside because of its provincial regulatory and clinical trial infrastructure. Meanwhile, many improvement programs in pharmaceutical area have been initiated in Japan. With this increased scrutiny, significant improvements in regulatory process, clinical trial costs, and site performance are anticipated over the next few years. RENAAL is the first multi-national clinical trial involving Japanese patients diabetic nephropathy associated with type II diabetes mellitus. In this article, issues which have been observed in the process of conducting multi-national clinical trial were discussed based on the experience with RENAAL. It is hoped that, as we gain more experiences in multi-national clinical trials, solutions for these issues are found in near future.

  4. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P;

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...... of antiandrogen (flutamide, Anandron, or cyproterone acetate) added to castration. This paper reviews the different types of heterogeneity that might exist among trials that are involved in the overview: study design, randomization procedure, treatment evaluation, statistical evaluation, and data maturity...... with a larger number of patients and a longer follow-up will contribute more to the overview's results....

  5. Discourse, Statement and Speech Act

    Directory of Open Access Journals (Sweden)

    Елена Александровна Красина

    2016-12-01

    Full Text Available Being a component of socio-cultural interaction discourse constitutes a sophisticated cohesion of language form, meaning and performance, i.e. communicative event or act. Cohesion with event and performance let us treat discourse as a certain lifeform, appealing both to communicative interaction and pragmatic environment using the methodology of studies of E. Benveniste, M. Foucault, I. Kecskes, J.R. Searle et al. In linguistics and other fields of humanitarian knowledge the notion of discourse facilitates the integration of studies in humanities. Principles of integration, incorporation into broad humanitarian context reveal some topics of discourse-speech act-utterance interaction which leads to substantive solutions of a number of linguistic topics, in particular, that of an utterance. Logicians determine utterance through proposition; linguists - through sentence, while speech act theory does it by means of illocutionary act. Integrated in a discourse or its part, utterance makes up their integral constituents although not unique ones. In relation to speech acts, utterance happens to be the unique definitional domain synchronically modelling and denoting speech act by means of propositional content. The goal of the research is to show the conditions of interaction and correlation of discourse, speech act and utterance as linguistic constructions, reveal some similarities and differences of their characteristics and prove the importance of the constructive role of utterance as a minimal unit of speech production. Discourse-speech act-utterance correlation supports the utterance role of a discrete unit within syntactic continuum, facing both language and speech: still, it belongs exclusively neither to language nor speech, but specifies their interaction in course of speech activity exposing simultaneously its nature of an ‘atom of discourse’ and creating the definitional domain of a speech act.

  6. From the Experience of Interactivity and Entertainment to Lower Intention to Smoke: A Randomized Controlled Trial and Path Analysis of a Web-Based Smoking Prevention Program for Adolescents.

    Science.gov (United States)

    Khalil, Georges Elias; Wang, Hua; Calabro, Karen Sue; Mitra, Natasha; Shegog, Ross; Prokhorov, Alexander V

    2017-02-16

    Web-based programs for smoking prevention are being increasingly used with some success among adolescents. However, little is known about the mechanisms that link the experience of such programs to intended nicotine or tobacco control outcomes. Based on the experiential learning theory and extended elaboration likelihood model, this study aimed to evaluate the impact of a Web-based intervention, A Smoking Prevention Interactive Experience (ASPIRE), on adolescents' intention to smoke, while considering the experience of interactivity and entertainment as predictors of reduced intention to smoke, under a transitional user experience model. A total of 101 adolescents were recruited from after-school programs, provided consent, screened, and randomized in a single-blinded format to 1 of 2 conditions: the full ASPIRE program as the experimental condition (n=50) or an online , text-based version of ASPIRE as the control condition (n=51). Data were collected at baseline and immediate follow-up. Repeated-measures mixed-effects models and path analyses were conducted. A total of 82 participants completed the study and were included in the analysis. Participants in the experimental condition were more likely to show a decrease in their intention to smoke than those in the control condition (beta=-0.18, P=.008). Perceived interactivity (beta=-0.27, P=.004) and entertainment (beta=-0.20, P=.04) were each associated with a decrease in intention to smoke independently. Results of path analyses indicated that perceived interactivity and perceived entertainment mediated the relationship between ASPIRE use and emotional involvement. Furthermore, perceived presence mediated the relationship between perceived interactivity and emotional involvement. There was a direct relationship between perceived entertainment and emotional involvement. Emotional involvement predicted a decrease in intention to smoke (beta=-0.16, P=.04). Adolescents' experience of interactivity and entertainment

  7. Inept media trials of clinical trials

    Directory of Open Access Journals (Sweden)

    N V Ramamurthy

    2012-01-01

    Full Text Available The Indian media in general, with the exception of a few domain expert journalists, have failed to comprehend the complexities involved in the clinical trial process. In the run up to the deadline-based coverage of a story, a majority of them fall short in conveying the right perspective to readers, but nevertheless they have been successful in sensationalizing an event in this arena. Possibly by unintended misrepresentation, or mostly out of ignorance of the nuances involved in the clinical trials process, the media has done more harm than good, and got away with it. On the other side, the industry has been reluctant to engage with the media in a meaningful dialog for too long now. It bears not only the consequences of damage to its professional reputation following such reportage, but also the repercussions of unnecessary clampdowns by the regulators. Science journalism in India has yet to rise as a profession.

  8. Impact of efalizumab on patient-reported outcomes in high-need psoriasis patients: results of the international, randomized, placebo-controlled Phase III Clinical Experience Acquired with Raptiva (CLEAR trial [NCT00256139

    Directory of Open Access Journals (Sweden)

    Shumack Stephen

    2005-12-01

    Full Text Available Abstract Background Chronic psoriasis can negatively affect patients' lives. Assessing the impact of treatment on different aspects of a patient's health-related quality of life (HRQOL is therefore important and relevant in trials of anti-psoriasis agents. The recombinant humanized IgG1 monoclonal antibody efalizumab targets multiple T-cell-dependent steps in the immunopathogenesis of psoriasis. Efalizumab has demonstrated safety and efficacy in several clinical trials, and improves patients' quality of life. Objective: To evaluate the impact of efalizumab on HRQOL and other patient-reported outcomes in patients with moderate to severe plaque psoriasis, including a large cohort of High-Need patients for whom at least 2 other systemic therapies were unsuitable because of lack of efficacy, intolerance, or contraindication. Methods A total of 793 patients were randomized in a 2:1 ratio to receive efalizumab 1 mg/kg/wk (n = 529 or placebo (n = 264 for 12 weeks. The study population included 526 High-Need patients (342 efalizumab, 184 placebo. The treatment was evaluated by patients using the HRQOL assessment tools Short Form-36 (SF-36 and Dermatology Life Quality Index (DLQI. Other patient-reported assessments included the Psoriasis Symptom Assessment (PSA, a visual analog scale (VAS for itching, and the Patient's Global Psoriasis Assessment (PGPA. Results Efalizumab was associated with improvements at Week 12 from baseline in patient-reported outcomes, both in the total study population and in the High-Need cohort. Among all efalizumab-treated patients, the DLQI improved by 5.7 points from baseline to Week 12, relative to an improvement of 2.3 points for placebo patients (P P Conclusion A 12-week course of efalizumab improved HRQOL and other patient-reported outcomes in patients with moderate to severe plaque psoriasis. The benefits of efalizumab therapy in High-Need patients were similar to those observed in the total study population, indicating

  9. Improving data transparency in clinical trials using blockchain smart contracts.

    Science.gov (United States)

    Nugent, Timothy; Upton, David; Cimpoesu, Mihai

    2016-01-01

    The scientific credibility of findings from clinical trials can be undermined by a range of problems including missing data, endpoint switching, data dredging, and selective publication. Together, these issues have contributed to systematically distorted perceptions regarding the benefits and risks of treatments. While these issues have been well documented and widely discussed within the profession, legislative intervention has seen limited success. Recently, a method was described for using a blockchain to prove the existence of documents describing pre-specified endpoints in clinical trials. Here, we extend the idea by using smart contracts - code, and data, that resides at a specific address in a blockchain, and whose execution is cryptographically validated by the network - to demonstrate how trust in clinical trials can be enforced and data manipulation eliminated. We show that blockchain smart contracts provide a novel technological solution to the data manipulation problem, by acting as trusted administrators and providing an immutable record of trial history.

  10. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial

    DEFF Research Database (Denmark)

    Madsbad, Sten; Schmitz, Ole; Ranstam, Jonas

    2004-01-01

    -group, placebo-controlled trial with an open-label comparator arm was conducted among 193 outpatients with type 2 diabetes. The mean age was 56.6 years and the mean HbA(1c) was 7.6% across the treatment groups. Patients were randomly assigned to one of five fixed-dosage groups of liraglutide (0.045, 0.225, 0....... Patients treated with glimepiride had decreased HbA(1c) and fasting glucose, but slightly increased body weight. No safety issues were raised for liraglutide; observed adverse events were mild and transient. CONCLUSIONS: A once-daily dose of liraglutide provides efficacious glycemic control...

  11. Treatment Resistant Depression with Loss of Antidepressant Response: Rapid—Acting Antidepressant Action of Dextromethorphan, A Possible Treatment Bridging Molecule

    Science.gov (United States)

    Lauterbach, Edward C.

    2016-01-01

    Dextromethorphan (DM) may have ketamine—like rapid—acting, treatment—resistant, and conventional antidepressant effects.1,2 This reports our initial experience with DM in unipolar Major Depressive Disorder (MDD). A patient with treatment—resistant MDD (failing adequate trials of citalopram and vortioxetine) with loss of antidepressant response (to fluoxetine and bupropion) twice experienced a rapid—acting antidepressant effect within 48 hours of DM administration and lasting 7 days, sustained up to 20 days with daily administration, then gradually developing labile loss of antidepressant response over the ensuing 7 days. Upon full relapse in DSM-5 MDD while taking 600 mg/day of the strong CYP2D6 inhibitor bupropion XL, a 300 mg oral loading dose of DM was given, followed by 60 mg po bid after an additional dose—finding period, without side effects. DM exhibited a ketamine—like rapid—acting antidepressant effect, thought to be mediated by mTOR activation (related to NMDA PCP site antagonism, sigma-1 and beta adrenergic receptor stimulation) and 5HTT inhibition, resulting in AMPA receptor trafficking, and dendritogenesis, spinogenesis, synaptogenesis, and increased neuronal survival (related to NMDA antagonism and sigma-1 and mTOR signaling). This report appears to be the first report of a rapid—acting effect in unipolar MDD and adds to antidepressant effects observed in the retrospective chart review of 77 patients with Bipolar II Disorder (Kelly and Lieberman 2014). If replicated, there is some reason to think that the administration of other agents with DM, such as lithium or D-cycloserine, might prolong the duration of the rapid-antidepressant effect. PMID:27738380

  12. Coping with Trial-to-Trial Variability of Event Related Signals: A Bayesian Inference Approach

    Science.gov (United States)

    Ding, Mingzhou; Chen, Youghong; Knuth, Kevin H.; Bressler, Steven L.; Schroeder, Charles E.

    2005-01-01

    In electro-neurophysiology, single-trial brain responses to a sensory stimulus or a motor act are commonly assumed to result from the linear superposition of a stereotypic event-related signal (e.g. the event-related potential or ERP) that is invariant across trials and some ongoing brain activity often referred to as noise. To extract the signal, one performs an ensemble average of the brain responses over many identical trials to attenuate the noise. To date, h s simple signal-plus-noise (SPN) model has been the dominant approach in cognitive neuroscience. Mounting empirical evidence has shown that the assumptions underlying this model may be overly simplistic. More realistic models have been proposed that account for the trial-to-trial variability of the event-related signal as well as the possibility of multiple differentially varying components within a given ERP waveform. The variable-signal-plus-noise (VSPN) model, which has been demonstrated to provide the foundation for separation and characterization of multiple differentially varying components, has the potential to provide a rich source of information for questions related to neural functions that complement the SPN model. Thus, being able to estimate the amplitude and latency of each ERP component on a trial-by-trial basis provides a critical link between the perceived benefits of the VSPN model and its many concrete applications. In this paper we describe a Bayesian approach to deal with this issue and the resulting strategy is referred to as the differentially Variable Component Analysis (dVCA). We compare the performance of dVCA on simulated data with Independent Component Analysis (ICA) and analyze neurobiological recordings from monkeys performing cognitive tasks.

  13. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase ...

  14. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... out if an experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or ... specific medical problem. These trials find out if lifestyle changes, such as exercising more, getting more sleep, ...

  15. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... a disease. A clinical trial may compare experimental products or tests to those already available or may ... Institutes of Health | U.S. Department of Health & Human Services Customer Support | Accessibility | Copyright | Privacy | Viewers and Players

  16. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Katz, J N; Losina, E; Lohmander, L S

    2015-01-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For eac...

  17. ClinicalTrials.gov

    Data.gov (United States)

    U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...

  18. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... new tests that could identify a disease in its early stages. Usually, trial participants must show signs ... often healthy people (20 to 80), to judge its safety and side effects, and to find the ...

  19. TRIAL BY PREVIEW

    National Research Council Canada - National Science Library

    Bert I. Huang

    2013-01-01

    ...—that is, the judge or the jury who will be the finder of fact at trial. Both theory and policy have focused narrowly on previewing the evidence, while barely noticing the complementary effect of previewing the audience...

  20. Polyp Prevention Trial

    Science.gov (United States)

    The primary objective of the Polyp Prevention Trial (PPT) is to determine whether a low fat, high fiber, high vegetable and fruit eating plan will decrease the recurrence of adenomatous polyps of the large bowel.

  1. Anchor Trial Launch

    Science.gov (United States)

    NCI has launched a multicenter phase III clinical trial called the ANCHOR Study -- Anal Cancer HSIL (High-grade Squamous Intraepithelial Lesion) Outcomes Research Study -- to determine if treatment of HSIL in HIV-infected individuals can prevent anal canc

  2. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or prevent a disease. A clinical trial may compare experimental products or tests to those already available or may compare existing ...

  3. Advanced Communications Technology Satellite (ACTS). Phase 1: Industrial/academic experimenters

    Science.gov (United States)

    Maisel, James E.; Nowlin, Robert W.

    1992-01-01

    This report presents the work done at Arizona State University under the ACTS Experimenters Program. The main thrust of the Program was to develop experiments to test, evaluate, and prove the commercial worthiness of the ACTS satellite which is scheduled for launch in 1993. To accomplish this goal, meetings were held with various governmental, industrial, and academic units to discuss the ACTS satellite and its technology and possible experiments that would generate industrial interest and support for ASU's efforts. Several local industries generated several experiments of their own. The investigators submitted several experiments of educational, medical, commercial, and technical value and interest. The disposition of these experimental proposals is discussed in this report.

  4. Short-Acting Beta-Agonist Research: A Perspective

    Directory of Open Access Journals (Sweden)

    Malcolm R Sears

    2001-01-01

    Full Text Available Asthma mortality increased sharply in New Zealand in 1977, prompting a national investigation into circumstances of asthma deaths. Subsequent observations of improved asthma control in subjects withdrawn from regular beta2-agonist treatment raised the question of whether asthma severity and, therefore, mortality could relate to frequent beta-agonist use. A randomized controlled trial of regular inhaled fenoterol versus as-needed bronchodilator use showed worsened asthma control during regular treatment despite concomitant use of inhaled corticosteroids. Assessment of these findings led to delay in the publishing of the American Asthma Guidelines, which were modified to suggest caution in using beta2-agonist treatments. Simultaneously, case control studies in New Zealand suggested that prescription of fenoterol was a substantial risk factor for asthma mortality. The causal association was hotly debated, but increasing evidence pointed to an adverse effect of fenoterol on asthma severity and, hence, mortality. This was supported by dramatic decreases in both morbidity and mortality when fenoterol was effectively withdrawn from use in New Zealand. The link between worsening asthma morbidity and mortality, and the use of potent short-acting beta2-agonists fulfills the Bradford Hill criteria for attributing causality. Application of evidence from randomized, controlled trials of short-acting beta-agonist use has led to a major shift in therapy in asthma to the recommendation of as-needed use only of short-acting beta-agonists and decreased patient reliance on regular bronchodilator therapy.

  5. Falsificationism and clinical trials.

    Science.gov (United States)

    Senn, S J

    1991-11-01

    The relevance of the philosophy of Sir Karl Popper to the planning, conduct and analysis of clinical trials is examined. It is shown that blinding and randomization can only be regarded as valuable for the purpose of refuting universal hypotheses. The purpose of inclusion criteria is also examined. It is concluded that a misplaced belief in induction is responsible for many false notions regarding clinical trials.

  6. Involving South Asian patients in clinical trials.

    Science.gov (United States)

    Hussain-Gambles, M; Leese, B; Atkin, K; Brown, J; Mason, S; Tovey, P

    2004-10-01

    To investigate how South Asian patients conceptualise the notion of clinical trials and to identify key processes that impact on trial participation and the extent to which communication difficulties, perceptions of risk and attitudes to authority influence these decisions. Also to identify whether 'South Asian' patients are homogeneous in these issues, and which factors differ between different South Asian subgroups and finally how professionals regard the involvement of South Asian patients and their views on strategies to increase participation. A review of the literature on minority ethnic participation in clinical trials was followed by three qualitative interview studies. Interviews were taped and transcribed (and translated if required) and subjected to framework analysis. Face-to-face interviews were conducted with 25 health professionals; 60 South Asian lay people who had not taken part in a trial and 15 South Asian trial participants. Motivations for trial participation were identified as follows: to help society, to improve own health or that of family and friends, out of obligation to the doctor and to increase scientific knowledge. Deterrents were concerns about drug side-effects, busy lifestyles, language, previous bad experiences, mistrust and feelings of not belonging to British society. There was no evidence of antipathy amongst South Asians to the concept of clinical trials and, overall, the younger respondents were more knowledgeable than the older ones. Problems are more likely to be associated with service delivery. Lack of being approached was a common response. Lay-reported factors that might affect South Asian participation in clinical trials include age, language, social class, feeling of not belonging/mistrust, culture and religion. Awareness of clinical trials varied between each group. There are more similarities than differences in attitudes towards clinical trial participation between the South Asian and the general population

  7. Endangered Species Act Critical Habitat

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Critical habitat (CH) is designated for the survival and recovery of species listed as threatened or endangered under the Endangered Species Act (ESA). Critical...

  8. VT Act 174 Wind Potential

    Data.gov (United States)

    Vermont Center for Geographic Information — (Link to Metadata) The statewide wind potential layer used in the Act 174 effort represents three combined wind resource layers: Potential Residential and Small and...

  9. Federal Technology Transfer Act (FTTA)

    Science.gov (United States)

    EPA's Federal Technology Transfer Act (FTTA) is a mechanism with which EPA can patent its inventions and license them to companies, through which innovative technologies can enter the marketplace to improve the environment and human health.

  10. Critical Care Implications of the Affordable Care Act.

    Science.gov (United States)

    Dogra, Anjali P; Dorman, Todd

    2016-03-01

    To provide an overview of key elements of the Affordable Care Act. To evaluate ways in which the Affordable Care Act will likely impact the practice of critical care medicine. To describe strategies that may help health systems and providers effectively adapt to changes brought about by the Affordable Care Act. Data sources for this concise review include search results from the PubMed and Embase databases, as well as sources relevant to public policy such as the text of the Patient Protection and Affordable Care Act and reports of the Congressional Budget Office. As all of the Affordable Care Act's provisions will not be fully implemented until 2019, we also drew upon cost, population, and utilization projections, as well as the experience of existing state-based healthcare reforms. The Affordable Care Act represents the furthest reaching regulatory changes in the U.S. healthcare system since the 1965 Medicare and Medicaid provisions of the Social Security Act. The Affordable Care Act aims to expand health insurance coverage to millions of Americans and place an emphasis on quality and cost-effectiveness of care. From models which link pay and performance to those which center on episodic care, the Affordable Care Act outlines sweeping changes to health systems, reimbursement structures, and the delivery of critical care. Staffing models that include daily rounding by an intensivist, palliative care integration, and expansion of the role of telemedicine in areas where intensivists are inaccessible are potential strategies that may improve quality and profitability of ICU care in the post-Affordable Care Act era.

  11. Franz Kafka's The Trial: guilty or innocent?

    Science.gov (United States)

    Siegel, E

    1996-07-01

    Through an examination of The Trial by Kafka I attempt to show that the depiction of the Court apparatus is dynamically related to the commission of unconscious crimes of the type we encounter in our patients. To provide a context for the novel, I discuss Kafka's biography and some possible unconscious motivations. My goal is to show how the concept of a particular type of superego pressure can be used to understand the subtle irony in The Trial. Although Joseph K.'s behavior frequently involves oedipal crimes, there are many preoedipal themes that help account for his experience of the Court. I contrast this psychoanalytic understanding of K.'s guilt with that of literary critics who interpret The Trial as an allegory of guilt but who minimize the psychological dimensions.

  12. 7 CFR 33.1 - Act.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Act. 33.1 Section 33.1 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices... AUTHORITY OF THE EXPORT APPLE ACT Definitions § 33.1 Act. Act and Export Apple Act are synonymous and...

  13. 78 FR 68422 - Patent Trial and Appeal Board (PTAB) Actions (Formerly Board of Patent Appeals and Interferences...

    Science.gov (United States)

    2013-11-14

    ... directed to the attention of Linda Horner, Acting Vice Chief Judge, Patent Trial and Appeal Board, United...-9797; or by email to linda.horner@uspto.gov . Additional information about this collection is...

  14. THE CHILD JUSTICE ACT: PROCEDURAL SENTENCING ISSUES

    Directory of Open Access Journals (Sweden)

    Stephan S Terblanche

    2013-04-01

    Full Text Available In this contribution a number of procedural issues related to the sentencing of child offenders and emanating from the Child Justice Act 75 of 2008 are considered in some detail. As a general rule, the Act requires pre-sentence reports to be obtained from probation officers before sentencing any child offender, with only a limited number of exceptions. The article argues that the peremptory nature of the Act means that a probation report is always required, even if reports by other experts are also available. The exceptions are limited to instances other than those where the child offender is sentenced to any form of imprisonment or to residence in a care centre. The article addresses the question of whether or not the reference to imprisonment includes alternative imprisonment which is imposed only as an alternative to a fine. It suggests that alternative imprisonment should, generally, not be imposed on child offenders. When an exception is not prevented because of the sentence, a pre-sentence report may be dispensed with only when the offence is a schedule-1 offence (the least serious class of offences or when obtaining a report would prejudice the child. It is argued that these exceptions are likely to occur rather rarely. A final aspect of the Act’s provisions on pre-sentence reports is the requirement that reasons be given for a departure from the recommendations in a pre-sentence report. This requirement merely confirms the status quo.The Act permits the prosecutor to provide the court with a victim impact statement. Such a statement is defined in the Act. It is a sworn statement by a victim or someone authorised by the victim explaining the consequences to the victim of the commission of the crime. The article also addresses the issue of whether or not the child justice court might mero motu obtain a victim impact statement when the prosecution does not do so.Finally, the article addresses appeals against and reviews of the trial

  15. Pre-trial evaluation of the potential for unblinding in drug trials: a prototype example.

    Science.gov (United States)

    Walter, S D; Awasthi, Shally; Jeyaseelan, L

    2005-08-01

    Blinding is an important design feature of randomised trials that may reduce bias in the results, compared to the situation where blinding is not possible or is not maintained. The literature provides some guidance for the evaluation of blinding in ongoing or completed studies, but the question of pre-trial assessment of the potential for unblinding has not been addressed. This paper describes the design and analysis of a prototype experiment for the pre-trial assessment of blinding in a drug trial. This work was motivated by a trial using antibiotic therapy, in which the investigators were concerned about the possibility of subjects being able to differentiate active medication from placebo, and thus become unblinded to their treatment assignment. A small experiment was mounted in which participants had to divide a random mixture of tablets into two groups. Statistical methods were developed to calculate the probability of a given number of similar tablets being classified into the same group by chance, with a modification to allow for some participants having constrained their responses to have equal numbers of tablets in each group. Differentiation of tablets by taste (the initial concern of the investigators) was not statistically different from chance. A smaller set of data on differentiation by appearance (a possibility not originally considered) had borderline statistical significance. After reviewing all these results, the investigators decided to proceed with the study without modifying the tablets, in part because subjects in the study would be unlikely to compare the two types of medication side-by-side. Our results suggest that blinding might sometimes be compromised in unexpected ways. Whenever possible, we suggest that similar and larger such experiments be carried out before the trial to assess whether blinding might be compromised. The methods proposed here could easily be adapted to evaluate the results of such experiments.

  16. Acting and Teacher Education: Being Model for Identity Development

    Directory of Open Access Journals (Sweden)

    Kemal Sinan Özmen

    2011-04-01

    Full Text Available This study follows three pre-service teachers during three academic semesters in which they took an acting course for teachers and participated in practicum with a special focus on rehearsing and developing their teacher identities. In order to create the necessary context for them, an acting course for pre-service teacher education was designed in parallel with a model which is based on an influential acting theory. This model, namely the BEING (Believe, Experiment, Invent, Navigate, Generate, was also designed by the researcher. The incentive behind designing a model grounded on acting literature was that the relevant literature does not provide trainers with a universal model which can be referred as a manual for running and monitoring acting courses for teachers. In this case study, this model was also tested in terms of its applicability and functionality in practice. Based on analyses of audio taped interviews, session journals and reflections, the five stages of the BEING Model was found to be highly applicable and functional in terms of reflecting the natural development process of teacher identity development. Pre-service teachers displayed a significant development in communication skills and professional identities. Therefore, the BEING model provides a perspective and a philosophy of benefiting from acting literature for teacher educators with little or no knowledge on acting and theatre.

  17. Optimizing detector trials for humanitarian demining

    Science.gov (United States)

    Gaal, Mate; Baer, Sylke; Bloodworth, Thomas J.; Guelle, Dieter; Lewis, Adam M.; Mueller, Christina; Scharmach, Martina

    2004-09-01

    The performance of mine detecting instruments is embedded in the behavior of a complex system. The total reliability is always composed of the intrinsic physical detection capability of the sensor, application/environmental influences and human factors. The intrinsic capability and some application factors can be investigated in laboratory measurements. Human factors, other application factors and the overall reliability, can only be evaluated in blind field trials in which the probability of detection (PoD) and false alarm rate (FAR) are measured statistically. Both of these approaches are included in CEN Workshop Agreement CWA 14747:2003, which standardizes detector testing in Humanitarian Demining. We report here the results of a study to investigate how to optimize such testing. For efficient and statistically valid field trials, the number, types and burial depths of targets, and the number of test lanes, soil types, repetitions and operators need to be carefully chosen. Laboratory results should be used to help construct field trial protocols and also to help distinguish the different contributions to the PoD and FAR, to determine where to improve insufficient performance. In this study, four models of metal detector were tested in three field trials and in the laboratory. The repeatability of the field trials is assessed, taking into account operator training and experience. Results of the laboratory tests are compared with results of the field trials and used to construct a "modular model" of the system, as used in nondestructive testing. The conclusions are, in principle, applicable to trials of other types of sensor.

  18. Clobazam is efficacious for patients across the spectrum of disease severity of Lennox-Gastaut syndrome: post hoc analyses of clinical trial results by baseline seizure-frequency quartiles and VNS experience.

    Science.gov (United States)

    Wheless, James W; Isojarvi, Jouko; Lee, Deborah; Drummond, Rebecca; Benbadis, Selim R

    2014-12-01

    Lennox-Gastaut syndrome (LGS) severity varies considerably, so the potential impact of differences in baseline severity on patient outcome following treatment is clinically informative. Here, two surrogate indicators of LGS severity (baseline seizure frequency and vagus nerve stimulation [VNS] use) were used in post hoc analyses of both short- and long-term clobazam trials (Phase III OV-1012 [CONTAIN] and open-label extension [OLE] OV-1004). In CONTAIN, 217 patients comprised the modified, intention-to-treat population. Each baseline seizure-frequency quartile had ~40 patients, and baseline weekly drop-seizure frequency ranges were as follows: clobazam-treated patients (vs. 7% for placebo) in Quartile 1. Five percent of clobazam-treated patients in Quartile 4 (most severe LGS) vs. 0% for placebo achieved 100% reduction in drop seizures. A total of 267 of 306 possible patients entered the OLE (61/68 from a Phase II study and 206/238 from Phase III CONTAIN). Each quartile had ~66 patients, and baseline weekly drop-seizure ranges were as follows: 50% of patients in all 4 quartiles demonstrated ≥ 50% decreases in weekly frequency for drop seizures. More than 12% of patients in Quartile 4 achieved 100% reduction in drop seizures from Month 3 through Year 5. For the VNS analyses in CONTAIN, the least-squares mean decreases in average weekly rate of drop seizures (mITT population) were 52% for VNS patients receiving clobazam vs. -22% for placebo (p clobazam and 26% for placebo (p clobazam-treated patients in the VNS and non-VNS groups demonstrated ≥ 50% decreases in average weekly drop- and total-seizure frequencies, and 11% and 14% in the two groups achieved drop-seizure freedom, respectively. Analyses using baseline seizure frequency and VNS use as surrogates for disease severity showed that clobazam treatment of patients with less severe or severe LGS was equally efficacious.

  19. Novel ocular antihypertensive compounds in clinical trials

    Directory of Open Access Journals (Sweden)

    Chen J

    2011-05-01

    Full Text Available June Chen1, Stephen A Runyan1, Michael R Robinson21Department of Biological Sciences, 2Ophthalmology Clinical Research, Allergan, Inc, Irvine, CA, USAIntroduction: Glaucoma is a multifactorial disease characterized by progressive optic nerve injury and visual field defects. Elevated intraocular pressure (IOP is the most widely recognized risk factor for the onset and progression of open-angle glaucoma, and IOP-lowering medications comprise the primary treatment strategy. IOP elevation in glaucoma is associated with diminished or obstructed aqueous humor outflow. Pharmacotherapy reduces IOP by suppressing aqueous inflow and/or increasing aqueous outflow.Purpose: This review focuses on novel non-FDA approved ocular antihypertensive compounds being investigated for IOP reduction in ocular hypertensive and glaucoma patients in active clinical trials within approximately the past 2 years.Methods: The mode of IOP reduction, pharmacology, efficacy, and safety of these new agents were assessed. Relevant drug efficacy and safety trials were identified from searches of various scientific literature databases and clinical trial registries. Compounds with no specified drug class, insufficient background information, reformulations, and fixed-combinations of marketed drugs were not considered.Results: The investigational agents identified comprise those that act on the same targets of established drug classes approved by the FDA (ie, prostaglandin analogs and β-adrenergic blockers as well as agents belonging to novel drug classes with unique mechanisms of action. Novel targets and compounds evaluated in clinical trials include an actin polymerization inhibitor (ie, latrunculin, Rho-associated protein kinase inhibitors, adenosine receptor analogs, an angiotensin II type 1 receptor antagonist, cannabinoid receptor agonists, and a serotonin receptor antagonist.Conclusion: The clinical value of novel compounds for the treatment of glaucoma will depend

  20. Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations

    Science.gov (United States)

    The Growth Hormone (GH) Research Society (GRS) convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting growth hormone preparations (LAGH). A closed meeting of 55 international scientists with expertise in GH, including pediatric and adult endocrino...

  1. Long-acting somatostatin analog therapy of acromegaly: A meta-analysis

    NARCIS (Netherlands)

    P.U. Freda (Pamela); L. Katznelson (Laurence); A-J. van der Lely (Aart-Jan); F. Reyes; S. Zhao (Shouhao); D. Rabinowitz (Daniel)

    2005-01-01

    textabstractContext: Although considerable data exist on the use of long-acting somatostatin analogs to treat acromegaly, their reported efficacy differs substantially among trials. Objective: We conducted a meta-analysis to derive definitive estimates of their efficacy for biochemical control and

  2. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study

    OpenAIRE

    2014-01-01

    Background Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. Methods A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Results Interviewees described the added value of qualitative research for the...

  3. Ethics and clinical trials.

    Science.gov (United States)

    Chassany, O; Duracinský, M

    1999-01-01

    The current reference guideline about ethics in clinical trials is the Declaration of Helsinki of human rights in medical research. Three major principles are emphasised: respect of the patient to accept or not to participate in a trial, the constraints and the presumed risks must be acceptable for patients included in a study, and vulnerable subjects should not participate in studies. The investigator is responsible for obtaining a free and well-informed consent from patients before their inclusion in a study. Where possible, a new drug should always first be compared to placebo in order to prove its superiority. Else, a small-sized trial comparing a new drug versus a reference treatment can lead to an erroneous conclusion of absence of difference. Moreover, good results or improvement are obtained in at least 30% of cases with placebo, whatever the disease. The use of placebo is unethical in life-threatening diseases and when an effective proved drug exists. The use of placebo is ethical in severe diseases with no efficient drug, in some severe diseases even when an active reference treatment is available, and in all moderate and functional diseases. In order to detect flawed studies, most journals now ask for any manuscript submitted and reporting results of a randomised clinical trial to join a checklist in order to verify the quality of the trial. Finally, it remains the responsibility of the doctor to decide whether or not a protocol is ethical, to participate or not and to include patients or not.

  4. Occasional Reinforced Trials during Extinction Can Slow the Rate of Rapid Reacquisition

    Science.gov (United States)

    Bouton, Mark E.; Woods, Amanda M.; Pineno, Oskar

    2004-01-01

    Two appetitive conditioning experiments with rats examined reacquisition after conditioned responding was eliminated by either extinction or by a partial reinforcement procedure in which reinforced trials were occasionally presented among many nonreinforced trials. In Experiment 1, reacquisition to a conditional stimulus (CS) that had been…

  5. Effects of Pre-Trial Response Requirements on Self-Control Choices by Rats and Pigeons

    Science.gov (United States)

    Mazur, James E.

    2012-01-01

    Parallel experiments with rats and pigeons examined whether the size of a pre-trial ratio requirement would affect choices in a self-control situation. In different conditions, either 1 response or 40 responses were required before each trial. In the first half of each experiment, an adjusting-ratio schedule was used, in which subjects could…

  6. The Equal Pay Act: The First 30 Years.

    Science.gov (United States)

    Crampton, Suzanne M.; Hodge, John W.; Mishra, Jitendra M.

    1997-01-01

    Analysis by decade of the effects of the Equal Pay Act of 1963 shows that women's earnings relative to men's increased by 10 cents from 1960-1990. Black and Hispanic women's earnings lagged further behind. More education and experience did not help women narrow the gap. (SK)

  7. Trial-by-trial switching between procedural and declarative categorization systems.

    Science.gov (United States)

    Crossley, Matthew J; Roeder, Jessica L; Helie, Sebastien; Ashby, F Gregory

    2016-11-30

    Considerable evidence suggests that human category learning recruits multiple memory systems. A popular assumption is that procedural memory is used to form stimulus-to-response mappings, whereas declarative memory is used to form and test explicit rules about category membership. The multiple systems framework has been successful in motivating and accounting for a broad array of empirical observations over the past 20 years. Even so, only a couple of studies have examined how the different categorization systems interact. Both previous studies suggest that switching between explicit and procedural responding is extremely difficult. But they leave unanswered the critical questions of whether trial-by-trial system switching is possible, and if so, whether it is qualitatively different than trial-by-trial switching between two explicit tasks. The experiment described in this article addressed these questions. The results (1) confirm that effective trial-by-trial system switching, although difficult, is possible; (2) suggest that switching between tasks mediated by different memory systems is more difficult than switching between two declarative memory tasks; and (3) point to a serious shortcoming of current category-learning theories.

  8. Assertive Community Treatment For People With Alcohol Dependence: A Pilot Randomized Controlled Trial

    Science.gov (United States)

    Gilburt, Helen; Burns, Tom; Copello, Alex; Crawford, Michael; Day, Ed; Deluca, Paolo; Godfrey, Christine; Parrott, Steve; Rose, Abigail; Sinclair, Julia; Coulton, Simon

    2017-01-01

    Abstract Aims A pilot randomized controlled trial (RCT) to assess the feasibility and potential efficacy of assertive community treatment (ACT) in adults with alcohol dependence. Methods Single blind, individually randomized, pilot RCT of 12 months of ACT plus treatment as usual (TAU) versus TAU alone in adults (age 18+ years) with alcohol dependence and a history of previous unsuccessful alcohol treatment attending specialist community alcohol treatment services. ACT aimed to actively engage participants for 12 months with assertive, regular, minimum weekly contact. ACT was combined with TAU. TAU comprised access to the full range of services provided by the community teams. Primary outcome is mean drinks per drinking day and percent days abstinent at 12 months follow up. Analysis of covariance was conducted using 80% confidence intervals, appropriate in the context of a pilot trial. Results A total of 94 participants were randomized, 45 in ACT and 49 in TAU. Follow-up was achieved with 98 and 88%, respectively at 12 months. Those in ACT had better treatment engagement, and were more often seen in their homes or local community than TAU participants. At 12 months the ACT group had more problems related to drinking and lower quality of life than TAU but no differences in drinking measures. The ACT group had a higher percentage of days abstinent but lower quality of life at 6 months. The ACT group had less unplanned healthcare use than TAU. Conclusions An trial of ACT was feasible to implement in an alcohol dependent treatment population. Trial registration ISRCTN22775534 PMID:27940571

  9. WP6 - Application Integration, Trials and Evaluation

    DEFF Research Database (Denmark)

    Prasad, Neeli R.; Cetin, Bilge Kartal; Moran, Humberto

    2009-01-01

    of the Total cost of ownership (TCO) associated to RFID systems as well as to confirm the ease of implementation of ASPIRE open source software (OSS) components into current IT SME infrastructure.The different pilot trials described in this deliverable are the following: • A Logistics pilot for the packing...... trials mainly consist of controlled and carefully designed experiments that will be organized either by those partners of the consortium who have previous experience on demos or similar events for small and medium enterprises (SMEs), or by other institutions that have accepted to test the ASPIRE...... industry to be setup at SENSAP S.A in Greece. • A pilot for company STAFF-Jeans SA, which focuses on two distinct yet complementary scenarios, namely logistics and retail scenarios for the apparel-textiles industry • PV Lab pilot, which is demonstration pilot that aims at showcasing the ASPIRE middleware....

  10. The FOCUS trial

    DEFF Research Database (Denmark)

    Glenthøj, Louise B; Fagerlund, Birgitte; Randers, Lasse

    2015-01-01

    trial enrolling 126 patients meeting the standardised criteria of being at UHR for psychosis. Patients are recruited from psychiatric in- and outpatient facilities in the Copenhagen catchment area. Patients are randomised to one of the two treatment arms: cognitive remediation plus standard treatment...... functioning, psychosis-like symptoms, negative symptomatology, and depressive symptomatology as measured with the Personal and Social Performance Scale, Brief Psychiatric Rating Scale-Expanded Version, Scale for the Assessment of Negative Symptoms, and the Montgomery-Åsberg Depression Rating Scale. DISCUSSION......: This is the first trial to evaluate the effects of neurocognitive and social cognitive remediation in UHR patients. The FOCUS trial results will provide evidence on the effect of targeted and comprehensive cognitive rehabilitation on cognition, daily living, and symptomatology as well as long-term outcome...

  11. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...... of reasons but in particular, to determine whether biomarkers are useful in identifying those individuals most likely to receive clinically important benefits from an intervention; and to determine whether biomarkers are useful for identifying individuals at earlier stages of OA in order to institute...... both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials...

  12. Act 7 Ask for Commitment

    Institute of Scientific and Technical Information of China (English)

    Duane Sparks from KMG

    2008-01-01

    <正>"I’ll bite.How does Action Selling define an objection?""Action Selling defines an objection as a customer’s response to an unasked question,"Joe said."Every objection you’ll ever hear will relate to one of the customer’s five buying decisions.And all of the objections you hear could have been uncovered during Act 3 instead of in Act 7.""Come again?"Matt asked."This is important,so listen up,"Joe said."If you had followed the"Ask the Best Questions Map"carefully in Act 3 to determine the needs,issues,competition,budget,buying influences,and time frame,then objections you hear at the end of

  13. The Problem of Agency; How Humans Act, How Machines Act

    DEFF Research Database (Denmark)

    Rose, Jeremy; Jones, M.; Truex, D.

    2003-01-01

    A long-standing debate in the IS literature concerns the relationship between technology and organization. Is it technology that acts on organizations, or humans that determine how technology is used? Proposals for a middle way between the extremes of technological and social determinism have been...

  14. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.;

    2015-01-01

    The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct...... and index knee, describing interventions, patient-reported and physical performance measures, structural outcome measures, biochemical biomarkers, and reporting recommendations. In summary, the working group identified 25 recommendations that represent the current best practices regarding clinical trials...... that target symptom or structure modification among individuals with knee OA. These updated recommendations incorporate novel technologies (e.g., magnetic resonance imaging (MRI)) and strategies to address the heterogeneity of knee OA....

  15. Advanced Communications Technology Satellite (ACTS)

    Science.gov (United States)

    Gedney, Richard T.; Schertler, Ronald J.

    1989-01-01

    The NASA Advanced Communications Technology Satellite (ACTS) was conceived to help maintain U.S. leadership in the world's communications-satellite market. This experimental satellite is expected to be launched by NASA in 1992 and to furnish the technology necessary for establishing very small aperture terminal digital networks which provide on-demand full-mesh connectivity, and 1.544-MBPS services with only a single hop. Utilizing on-board switching and processing, each individual voice or data circuit can be separately routed to any location in the network. This paper provides an overview of the ACTS and discusses the value of the technology for future communications systems.

  16. Organisation of a clinical trial unit--a proposal

    DEFF Research Database (Denmark)

    Gluud, C; Sørensen, T I

    1998-01-01

    The urgent need for the performance of more, better designed, and better conducted randomised clinical trials is increasingly recognised. Based on structured interviews with leading persons of 43 outstanding organisations and units involved in clinical trials in Europe and North America during 1993......, ways of organising and staffing clinical trial units were investigated. The present proposal is based on this experience from which an attempt to extract a composite set of minimal requirements has been made regarding pertinent objectives and aims, organisational aspects, staffing, and estimated costs...... to a total cost for coordination per trial of about GBP 340,000. However, with a larger staff more studies may be coordinated possibly reducing the cost per trial depending on greater effectiveness in utilisation of the basic facilities....

  17. Implications of geographical variation on clinical outcomes of cardiovascular trials.

    Science.gov (United States)

    Mentz, Robert J; Kaski, Juan-Carlos; Dan, Gheorghe-Andrei; Goldstein, Sidney; Stockbridge, Norman; Alonso-Garcia, Angeles; Ruilope, Luis M; Martinez, Felipe A; Zannad, Faiez; Pitt, Bertram; Fiuzat, Mona; O'Connor, Christopher M

    2012-09-01

    Cardiovascular clinical trials are increasingly conducted globally as a means to reduce costs, expedite timelines, provide broad applicability, and satisfy regulatory authorities. Potential problems with trial globalization include regional differences in patient characteristics, medical practice patterns, and health policies which may influence outcomes and limit generalizability. Moreover, concerns have been raised about ethical misconduct and unsatisfactory quality oversight in regions with less trial experience and infrastructure. This article reviews geographical differences in cardiovascular trials in heart failure, acute coronary syndromes, hypertension and atrial fibrillation. It also explores potential explanations for these differences and methods to standardize the presentation of trial results. This review is based on discussions between basic scientists and clinical trialists at the 8th Global Cardio Vascular Clinical Trialists Forum 2011 in Paris, France, from December 2 to 3. Copyright © 2012 Mosby, Inc. All rights reserved.

  18. Asymptomatic carotid stenosis: What we can learn from the next generation of randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Mark N Rubin

    2014-04-01

    Full Text Available Stroke remains an exceedingly incident and prevalent public health burden across the globe, with an estimated 16 million new strokes per annum and prevalence over 60 million, and extracranial internal carotid artery atherosclerotic disease is an important risk factor for stroke. Randomized trials of surgical treatment were conducted (North American Symptomatic Carotid Endarterectomy Trial, European Carotid Surgery Trial and demonstrated efficacy of carotid endarterectomy for secondary prevention of stroke in patients with cerebrovascular events (e.g. ipsilateral stroke, transient ischemic attack, and/or amaurosis fugax attributable to a diseased artery with 50–99% stenosis. Therapeutic clarity, however, proved elusive with asymptomatic carotid artery disease. Asymptomatic Carotid Atherosclerosis Study (ACAS, Asymptomatic Carotid Surgery Trial, and Veterans Affairs Cooperative Study (VACS suggested only modest benefit from surgical intervention for primary stroke prevention and the best medical therapy at the time of these trials is not comparable to modern medical therapy. ACT-1, Asymptomatic Carotid Surgery Trial-2, Stent-Protected Angioplasty in asymptomatic Carotid artery stenosis versus Endarterectomy Trial-2, European Carotid Surgery Trial-2, Carotid Revascularization Endarterectomy Versus Stenting Trial-2 are trials that are recent, ongoing, or in development that include diverse populations across Europe and North America, complementary trial designs, and a collaborative spirit that should provide clinicians with evidence that informs best clinical practice for asymptomatic carotid artery disease.

  19. Long-acting muscarinic antagonists (LAMA) added to combination long-acting beta2-agonists and inhaled corticosteroids (LABA/ICS) versus LABA/ICS for adults with asthma.

    Science.gov (United States)

    Kew, Kayleigh M; Dahri, Karen

    2016-01-21

    Maintenance treatment with long-acting beta2-agonists and inhaled corticosteroids (LABA/ICS) can relieve asthma symptoms and reduce the frequency of exacerbations, but there are limited treatment options for people who do not gain control on combination LABA/ICS. Long-acting muscarinic antagonists (LAMA) are a class of inhaled drug which have been effective for people with chronic obstructive pulmonary disease and are now becoming available for people with asthma to take alongside their LABA/ICS inhaler. To assess the effects of adding a long-acting muscarinic antagonist (LAMA) to combination long-acting beta2-agonists (LABA) and inhaled corticosteroids (ICS) in adults whose asthma is not well controlled by LABA/ICS. We identified trials from the Cochrane Airways Review Group Specialised Register (CAGR) up to January 2016. We also searched ClinicalTrials.gov, the WHO trials portal, and reference lists of other reviews, and we contacted trial authors for additional information. We included parallel randomised controlled trials (RCTs) of at least 12 weeks' duration. Studies met the inclusion criteria if they compared LAMA as an add-on to LABA/ICS versus LABA/ICS alone for adults with asthma. We included studies reported as full text, those published as abstract only, and unpublished data. Primary outcomes were exacerbations requiring oral corticosteroids (OCS), validated measures of asthma control, and serious adverse events (including mortality). Two review authors screened searches and independently extracted details on risk of bias and numerical data. We analysed dichotomous data as odds ratios (ORs) and continuous data as mean differences (MD) using a random-effects model. We rated all outcomes using GRADE. We found four double-blind, double-dummy trials comparing LAMA to placebo, including 1197 people with asthma taking combination LABA/ICS. One of the trials was designed to study glycopyrronium bromide but was withdrawn prior to enrolment, and the other three

  20. Acceptance and commitment therapy for fibromyalgia: a randomized controlled trial.

    Science.gov (United States)

    Wicksell, R K; Kemani, M; Jensen, K; Kosek, E; Kadetoff, D; Sorjonen, K; Ingvar, M; Olsson, G L

    2013-04-01

    Fibromyalgia (FM) is characterized by widespread pain and co-morbid symptoms such as fatigue and depression. For FM, medical treatments alone appear insufficient. Recent meta-analyses point to the utility of cognitive behaviour therapy (CBT), but effects are moderate. Within the continuous development of CBT, the empirical support for acceptance and commitment therapy (ACT) has increased rapidly. ACT focuses on improving functioning by increasing the patient's ability to act in accordance with personal values also in the presence of pain and distress (i.e., psychological flexibility). However, no study has yet explored the utility of ACT in FM. To evaluate the efficacy of ACT for FM and the role of psychological inflexibility as a mediator of improvement. In this randomized controlled trial, ACT was evaluated in comparison to a waiting list control condition. Forty women diagnosed with FM participated in the study. Assessments were made pre- and post-treatment and at 3 months of follow-up. The ACT intervention consisted of 12 weekly group sessions. Significant differences in favour of ACT were seen in pain-related functioning, FM impact, mental health-related quality of life, self-efficacy, depression, anxiety and psychological inflexibility. Changes in psychological inflexibility during the course of treatment were found to mediate pre- to follow-up improvements in outcome variables. The results correspond with previous studies on ACT for chronic pain and suggest the utility of ACT for FM as well as the role of psychological inflexibility as a mediator of improvement. © 2012 European Federation of International Association for the Study of Pain Chapters.

  1. Can we identify non-stationary dynamics of trial-to-trial variability?

    Directory of Open Access Journals (Sweden)

    Emili Balaguer-Ballester

    Full Text Available Identifying sources of the apparent variability in non-stationary scenarios is a fundamental problem in many biological data analysis settings. For instance, neurophysiological responses to the same task often vary from each repetition of the same experiment (trial to the next. The origin and functional role of this observed variability is one of the fundamental questions in neuroscience. The nature of such trial-to-trial dynamics however remains largely elusive to current data analysis approaches. A range of strategies have been proposed in modalities such as electro-encephalography but gaining a fundamental insight into latent sources of trial-to-trial variability in neural recordings is still a major challenge. In this paper, we present a proof-of-concept study to the analysis of trial-to-trial variability dynamics founded on non-autonomous dynamical systems. At this initial stage, we evaluate the capacity of a simple statistic based on the behaviour of trajectories in classification settings, the trajectory coherence, in order to identify trial-to-trial dynamics. First, we derive the conditions leading to observable changes in datasets generated by a compact dynamical system (the Duffing equation. This canonical system plays the role of a ubiquitous model of non-stationary supervised classification problems. Second, we estimate the coherence of class-trajectories in empirically reconstructed space of system states. We show how this analysis can discern variations attributable to non-autonomous deterministic processes from stochastic fluctuations. The analyses are benchmarked using simulated and two different real datasets which have been shown to exhibit attractor dynamics. As an illustrative example, we focused on the analysis of the rat's frontal cortex ensemble dynamics during a decision-making task. Results suggest that, in line with recent hypotheses, rather than internal noise, it is the deterministic trend which most likely underlies

  2. Paraconsistent semantics of speech acts

    NARCIS (Netherlands)

    Dunin-Kȩplicz, Barbara; Strachocka, Alina; Szałas, Andrzej; Verbrugge, Rineke

    2015-01-01

    This paper discusses an implementation of four speech acts: assert, concede, request and challenge in a paraconsistent framework. A natural four-valued model of interaction yields multiple new cognitive situations. They are analyzed in the context of communicative relations, which partially replace

  3. 78 FR 46256 - Privacy Act

    Science.gov (United States)

    2013-07-31

    ... From the Federal Register Online via the Government Publishing Office FEDERAL ELECTION COMMISSION 11 CFR Part 1 Privacy Act CFR Correction In Title 11 of the Code of Federal Regulations, revised as of January 1, 2012, on page 5, in Sec. 1.2, the words ``95 and 96 of the Internal Revenue Code of...

  4. Sport supporting act: terminology issues

    Directory of Open Access Journals (Sweden)

    Petr Vlček

    2013-01-01

    Full Text Available BACKGROUND: The text deals with terminology issues from an interdisciplinary point of view. It is based on two different disciplines, law and kinanthropology, in an area of their overlap. AIM: The aim of the author is to point out some possible legislative problems, which could arise due to the current reading of the sport supporting act (Act no. 115/2001. The second aim of the author is to contribute to the discussion of kinantropologists (possibly also the educational researchers and lawyers and to stress the importance of the systematic approach to terminology formulation. METHODS: The author uses the method of language interpretation. We also use the basic analytical methods, induction and deduction, while we stress the systematic approach to the term formulation. RESULTS: The analysis of the sport supporting act terminology shows some specific legislative problems, which could arise due to the definition of sport in the sport supporting act. The author discusses a possible alternative solution. CONCLUSION: According to the opinion of the author, clear, obvious and unified terminology of kinantropologists as specialists in their discipline should represent a source, from which other sciences could derive their terminology. Defined and inexpert terminology used in other disciplines should not be used as an argument for its adopting in kinanthropology.

  5. Acting against one's best judgement

    NARCIS (Netherlands)

    Peijnenburg, Adriana Johanna Maria

    1996-01-01

    Handelen tegen beter weten in (Acting Against One’s Best Judgment) heeft als ondertitel Een onderzoek naar praktisch redeneren, disposities en wilszwakte. De laatste term is daarbij cruciaal. Wat is wilszwakte - in het oud-Grieks akrasia of akrateia - en hoe valt het te verklaren? Wat gebeurt er pre

  6. The Iran Sanctions Act (ISA)

    Science.gov (United States)

    2009-06-04

    Petrobras (Brazil) $34 million ? Oct. 2004 Yadavaran (oil). Finalized December 9, 2007 Sinopec (China) $2 billion 185,000 bpd (by 2011) June...2006 Gamsar block (oil) Sinopec (China) $20 million ? Sept. 2006 Khorramabad block (oil) Norsk Hydro (Norway) $49 million ? The Iran Sanctions Act

  7. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.;

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...

  8. Participating in Clinical Trials

    Medline Plus

    Full Text Available skip navigation Help Search home health topics A-Z Videos A-Z about us Customer Support NIH SeniorHealth Built with You in Mind Resize Text: A A A Change Contrast print sign up Share Home > Health topics A-Z > Participating in Clinical Trials: About ...

  9. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... will not know if you are taking the medicine or the placebo until the clinical trial is over. How do ... can already get by prescription ) or sugar pills ( placebos ) with the new medicine may last longer than Phases I and II ...

  10. The CYTONOX trial

    DEFF Research Database (Denmark)

    Gade, Christina; Mikus, Gerd; Christensen, Hanne Rolighed

    2016-01-01

    will be defined by using well-tested probes; midazolam, chlorzoxazone and caffeine. Each of the probes will be administered as a single dose. Subsequently, blood and urine samples will be collected at pre-specified times. CONCLUSION: The aim of the CYTONOX trial is to investigate the in vivo activity of CYP3A4...

  11. Clinical Trial Basics

    Science.gov (United States)

    ... How Am I Protected? Mark Bowden / iStock Ethical guidelines The goal of clinical research is to develop knowledge that improves human ... data and decide whether the results have medical importance. Results from clinical trials are often published in peer-reviewed scientific ...

  12. 20 CFR 627.245 - Work experience.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Work experience. 627.245 Section 627.245... PROGRAMS UNDER TITLES I, II, AND III OF THE ACT Program Requirements § 627.245 Work experience. (a) Definition. Work experience means a short-term or part-time training assignment with a public or private...

  13. The Physics of Bird Flight: An Experiment

    Science.gov (United States)

    Mihail, Michael D.; George, Thomas F.; Feldman, Bernard J.

    2008-01-01

    This article describes an experiment that measures the forces acting on a flying bird during takeoff. The experiment uses a minimum of equipment and only an elementary knowledge of kinematics and Newton's second law. The experiment involves first digitally videotaping a bird during takeoff, analyzing the video to determine the bird's position as a…

  14. Exchanging Conflict Resolution in an Adaptable Implementation of ACT-R

    OpenAIRE

    Gall, Daniel; Frühwirth, Thom

    2014-01-01

    In computational cognitive science, the cognitive architecture ACT-R is very popular. It describes a model of cognition that is amenable to computer implementation, paving the way for computational psychology. Its underlying psychological theory has been investigated in many psychological experiments, but ACT-R lacks a formal definition of its underlying concepts from a mathematical-computational point of view. Although the canonical implementation of ACT-R is now modularized, this production...

  15. Reconsidering Acting: a few improvised and provisory thoughts on acting today

    Directory of Open Access Journals (Sweden)

    Patrice Pavis

    2016-01-01

    Full Text Available This paper summarizes my thoughts during the presentation of the conference Acting reconsidered. The study of the actor in contemporary performances should be reevaluated in the light of the experiments of the last fifty years, particularly performance art, post-dramatic theatre, participative theatre and many political theatre. The new tasks and conceptions of the actor are introduced. Stanislavki’s notion of psychological realism is questioned. The suggestion of de-dramatizing, delocalizing, de-training the actor might help the actor to orient oneself in the world.

  16. 76 FR 25665 - No Fear Act

    Science.gov (United States)

    2011-05-05

    ... COMMISSION No Fear Act AGENCY: American Battle Monuments Commission. ACTION: Notice. SUMMARY: The American... FEAR Act), as implemented by the Office of Personnel Management (OPM) regulations at 5 CFR part 724... Retaliation Act of 2002,'' which is now known as the No FEAR Act. See Public Law 107-174, codified at 5 U.S.C...

  17. 34 CFR 300.4 - Act.

    Science.gov (United States)

    2010-07-01

    ..., DEPARTMENT OF EDUCATION ASSISTANCE TO STATES FOR THE EDUCATION OF CHILDREN WITH DISABILITIES General Definitions Used in This Part § 300.4 Act. Act means the Individuals with Disabilities Education Act, as... 34 Education 2 2010-07-01 2010-07-01 false Act. 300.4 Section 300.4 Education Regulations of...

  18. 40 CFR 791.105 - Prohibited acts.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Prohibited acts. 791.105 Section 791.105 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) DATA REIMBURSEMENT Prohibited Acts § 791.105 Prohibited acts. Failure to provide information...

  19. 7 CFR 35.1 - Act.

    Science.gov (United States)

    2010-01-01

    ... Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE COMMODITY STANDARDS AND STANDARD CONTAINER REGULATIONS EXPORT GRAPES AND PLUMS Definitions § 35.1 Act. Act or Export Grape and Plum Act means “An Act to promote the foreign trade of...

  20. Adubação do algodoeiro: IX - Ensaios com diversos adubos fosfatados (3.ª série Fertilizer experiments with cotton: IX - Trials with various phosphorus fertilizers (3rd series

    Directory of Open Access Journals (Sweden)

    Ismar Ramos

    1960-01-01

    results obtained in eight experiments carried out from 1949-50 to 1954-55, in which superphosphate was compared with Hyperphosphate and Serrote-phosphate (ground rock phosphates on the basis of 0, 40 and 80 kilograms of P2O5 to the hectare in the presence of nitrogen and potash. The experiments were conducted for 2-5 yeors in the same plots and located on different soil types of the Planalto Paulista. In the overage of the six experiments located on soil which responded to phosphorus, with the 40-kilogram rate of application the yield increases due to Hyperphosphate and Serrote-phosphote were respectively half and one fourth of that caused by superphosphate; with the 80-kilogram rate, however, the response to Hyperphosphate was a little superior and that of Serrote-phosphate about equal to half the effect of superphosphate. The relative responses to the three phosphates were practically equal in the various soil types, but they changed appreciably in the course of the experiments. In the first year, while superphosphate increased considerably the yields, the responses to the other phosphates were very poor, even when they were applied at the 80-kilogram rate. However, starting from the second or third year the effects of the two rates of Hyperphosphate were a little superior to half the effects of the corresponding doses of superphosphate. Regarding Serrote-phosphate, at the 40-kilogram rate its effect was always very poor, but with the double rate it proved about half as efficient as superphosphate with the same amount of phosphorus.