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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. The Experiment as Act

    DEFF Research Database (Denmark)

    Søndergaard, Morten

    identify and locate the experiments of POEX65 as acts; and to ask the questions: what constitutes those acts as experiments? and how do we possibly archive them? My purpose, then, is to define the methodologies to obtain the contours of a post-phenomenology of experimental artistic production in order to...... be able to analyse the phenomena found at POEX65. Here I will use the notion of the ‘ontological theatre’ (Pickering), which, according to Pickering, is acted out in experimental art productions. The experiment could thus be seen as an ‘agency-realism’ – as an ‘act’ of relations across the aesthetics...

  3. Internet trials: participant experiences and perspectives

    Directory of Open Access Journals (Sweden)

    Mathieu Erin

    2012-10-01

    Full Text Available Abstract Background Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants’ attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial. Objective To obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research. Methods All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. Results 1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate. Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants’ comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience – a perceived benefit – and a lack connectedness and understanding – a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet

  4. Internet trials: participant experiences and perspectives

    OpenAIRE

    Mathieu Erin; Barratt Alexandra; Carter Stacy M; Jamtvedt Gro

    2012-01-01

    Abstract Background Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants’ attitudes towards Internet-based...

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

    Directory of Open Access Journals (Sweden)

    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

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

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

    2013-01-01

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

  8. rAAV human trial experience.

    Science.gov (United States)

    High, Katherine A; Aubourg, Patrick

    2011-01-01

    Recombinant AAV vectors have been used in clinical trials since the mid-1990s, with over 300 subjects enrolled in studies. Although there are not yet licensed AAV products, there are several clear examples of clinical efficacy, and recombinant AAV vectors have a strong safety record after administration both locally and systemically. This chapter provides a review of two types of studies that have shown efficacy, including studies for Leber's congenital amaurosis, a hereditary retinal degenerative disorder in which subretinal administration of AAV has shown efficacy in terms of improvement in multiple measures of visual/retinal function; and of Parkinson's disease which has also shown improvement in clinical and imaging studies after gene transfer to the CNS. The chapter also provides a detailed review of the results of studies of gene therapy for hemophilia, in which short-term efficacy was achieved, but expression of the donated gene failed to persist, likely due to an immune response to the vector. Safety issues relating to AAV-mediated gene transfer are discussed, including a detailed review of the single death to have occurred in an AAV gene therapy trial (likely unrelated to the AAV vector), and of issues related to integration and insertional mutagenesis, risk of germline transmission, and risks related to immune responses to either vector or transgene product. Finally, protocols for determining the presence of vector DNA in body fluids using real-time quantitative PCR, and for isolating, cryopreserving, and testing peripheral blood mononuclear cells for interferon-γ (IFN-γ) responses to capsid are described in detail. PMID:22034041

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

    Science.gov (United States)

    2010-01-01

    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 PMID:20920261

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

    Directory of Open Access Journals (Sweden)

    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

  11. Dasatinib first-line: Multicentric Italian experience outside clinical trials.

    Science.gov (United States)

    Breccia, Massimo; Stagno, Fabio; Luciano, Luigiana; Abruzzese, Elisabetta; Annunziata, Mario; D'Adda, Mariella; Maggi, Alessandro; Sgherza, Nicola; Russo-Rossi, Antonella; Pregno, Patrizia; Castagnetti, Fausto; Iurlo, Alessandra; Latagliata, Roberto; Cedrone, Michele; Di Renzo, Nicola; Sorà, Federica; Rege-Cambrin, Giovanna; La Nasa, Giorgio; Scortechini, Anna Rita; Greco, Giovanna; Franceschini, Luca; Sica, Simona; Bocchia, Monica; Crugnola, Monica; Orlandi, Esther; Guarini, Attilio; Specchia, Giorgina; Rosti, Gianantonio; Saglio, Giuseppe; Alimena, Giuliana

    2016-01-01

    Dasatinib was approved for the treatment of chronic phase (CP) chronic myeloid leukemia (CML) patients in first line therapy based on the demonstration of efficacy and safety reported in patients enrolled in clinical trials. We describe a multicentric Italian "real-life" experience of dasatinib used as frontline treatment outside clinical trials. One hundred and nine patients (median age 54 years) were treated from January 2012 to December 2013. Increased incidence of high risk patients were detected according to stratification (26% according to Sokal score, 19% according to Euro score and 16% according to EUTOS) when compared to company sponsored studies. Median time from diagnosis to start of dasatinib was 18 days. Ten patients received unscheduled starting dose (6 patients 50mg and 4 patients 80 mg QD), whereas 99 patients started with 100mg QD. At 3 months, 92% of patients achieved a BCR-ABL ratio less than 10%. At 6 months, the rate of CCyR was 91% and the rate of MR3 was 40%, with 8% of the patients reaching MR4.5. Ninety-three patients were evaluable at 12 months: the rate of MR3 was 62%, with MR4.5 being achieved by 19% of the patients. At a median follow-up of 12 months, 27 patients (24.7%) were receiving the drug at reduced dose. Two patients (1.8%) experienced a lymphoid blast crisis and the overall incidence of resistance was 8%. As regards safety, the major side effects recorded were thrombocytopenia, neutropenia and pleural effusions, which occurred in 22%, 10% and 8% of patients, respectively. Present results, achieved in a large cohort of patients treated outside clinical trials, further confirm the efficacy and safety of dasatinib as firstline treatment in CML. PMID:26643920

  12. Trial participants’ experiences of early enhanced speech and language therapy after stroke compared with employed visitor support: a qualitative study nested within a randomized controlled trial

    OpenAIRE

    Young, A.

    2012-01-01

    Objectives: To explore trial participants’ experiences of the process and outcomes of early, enhanced speech and language therapy after stroke with support from an employed visitor. Design: Qualitative study nested within a randomized controlled trial. Participants: Twney-two people who, after stroke, had a diagnosis of aphasia (12), dysarthria (5) or both (5) and who participated in the ACT NoW study. Setting: Eight English NHS usual care settings. Method: Individual interviews. Thematic con...

  13. From ACT-ONE to Miranda, a Translation Experiment

    OpenAIRE

    Charles, Nathan; Bowman, Howard; Thompson, Simon

    1997-01-01

    It is now almost universally acknowledged that the data language ACT-ONE associated with the formal description technique LOTOS is inappropriate for the purpose of OSI formal description. In response to this the LOTOS restandardisation activity plans to replace ACT-ONE with a functional language. Thus, compatibility between ACT-ONE and the replacement data language becomes an issue. In response to this, we present an experimental investigation of backward compatibility between ACT-ONE and the...

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

    Directory of Open Access Journals (Sweden)

    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

  15. Tolerance to bronchodilation during treatment with long-acting beta-agonists, a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hancox Robert J

    2005-09-01

    Full Text Available Abstract Background Regular use of beta-agonists leads to tolerance to their bronchodilator effects. This can be demonstrated by measuring the response to beta-agonist following bronchoconstriction using methacholine. However most studies have demonstrated tolerance after a period of beta-agonist withdrawal, which is not typical of their use in clinical practice. This study assessed tolerance to the bronchodilator action of salbutamol during ongoing treatment with long-acting beta-agonist. Methods Random-order, double-blind, placebo-controlled, crossover trial. After 1 week without beta-agonists, 13 asthmatic subjects inhaled formoterol 12 μg twice daily or matching placebo for 1 week. Eight hours after the first and last doses subjects inhaled methacholine to produce a 20% fall in FEV1. Salbutamol 100, 200 and 400 μg (cumulative dose was then given at 5-minute intervals and FEV1 was measured 5 minutes after each dose. After a 1 week washout subjects crossed over to the other treatment. Unscheduled use of beta-agonists was not allowed during the study. The main outcome variable was the area under the salbutamol response curve. Results The analysis showed a significant time by treatment interaction indicating that the response to salbutamol fell during formoterol therapy compared to placebo. After 1 week of formoterol the area under the salbutamol response curve was 48% (95% confidence interval 28 to 68% lower than placebo. This reduction in response remained significant when the analyses were adjusted for changes in the pre-challenge FEV1 and dose of methacholine given (p = 0.001. Conclusion The bronchodilator response to salbutamol is significantly reduced in patients taking formoterol. Clinically relevant tolerance to rescue beta-agonist treatment is likely to occur in patients treated with long-acting beta-agonists.

  16. Designing phase 3 sepsis trials: application of learned experiences from critical care trials in acute heart failure.

    Science.gov (United States)

    Mebazaa, Alexandre; Laterre, Pierre François; Russell, James A; Bergmann, Andreas; Gattinoni, Luciano; Gayat, Etienne; Harhay, Michael O; Hartmann, Oliver; Hein, Frauke; Kjolbye, Anne Louise; Legrand, Matthieu; Lewis, Roger J; Marshall, John C; Marx, Gernot; Radermacher, Peter; Schroedter, Mathias; Scigalla, Paul; Stough, Wendy Gattis; Struck, Joachim; Van den Berghe, Greet; Yilmaz, Mehmet Birhan; Angus, Derek C

    2016-01-01

    Substantial attention and resources have been directed to improving outcomes of patients with critical illnesses, in particular sepsis, but all recent clinical trials testing various interventions or strategies have failed to detect a robust benefit on mortality. Acute heart failure is also a critical illness, and although the underlying etiologies differ, acute heart failure and sepsis are critical care illnesses that have a high mortality in which clinical trials have been difficult to conduct and have not yielded effective treatments. Both conditions represent a syndrome that is often difficult to define with a wide variation in patient characteristics, presentation, and standard management across institutions. Referring to past experiences and lessons learned in acute heart failure may be informative and help frame research in the area of sepsis. Academic heart failure investigators and industry have worked closely with regulators for many years to transition acute heart failure trials away from relying on dyspnea assessments and all-cause mortality as the primary measures of efficacy, and recent trials have been designed to assess novel clinical composite endpoints assessing organ dysfunction and mortality while still assessing all-cause mortality as a separate measure of safety. Applying the lessons learned in acute heart failure trials to severe sepsis and septic shock trials might be useful to advance the field. Novel endpoints beyond all-cause mortality should be considered for future sepsis trials. PMID:27034779

  17. Supporting positive experiences and sustained participation in clinical trials: looking beyond information provision.

    Science.gov (United States)

    Gillies, Kate; Entwistle, Vikki A

    2012-12-01

    Recruitment processes for clinical trials are governed by guidelines and regulatory systems intended to ensure participation is informed and voluntary. Although the guidelines and systems provide some protection to potential participants, current recruitment processes often result in limited understanding and experiences of inadequate decision support. Many trials also have high drop-out rates among participants, which are ethically troubling because they can be indicative of poor experiences and they limit the usefulness of the knowledge the trials were designed to generate. Drawing on recent social-psychological and philosophical-ethical research on trial recruitment and patient participation in treatment decision-making, this paper identifies possibilities for improving communicative support for both initial decisions and ongoing participation in clinical trials. It highlights the potential of a shift in thinking about 'voluntariness', underpinned by relational understandings of autonomy, to encourage more nuanced judgements about the ethics of communication between trial staff and (potential) participants. The paper suggests that the idea of responsively enabling people to consider invitations or requests to participate in particular trials could serve as a general guide to communication. This might help ensure decisions about trial participation are meaningfully informed and voluntary, and that relationships between trial staff and participants contribute to positive experiences of trial participation and ultimately to the generation of the robust knowledge.

  18. Clinical trial experience using erythropoietin during radiation therapy

    International Nuclear Information System (INIS)

    Oncologists have several reasons for trying to maintain or increase hemoglobin levels in their patients during therapy. Relief of the symptoms of anemia, including fatigue and dyspnea, are traditional, well-accepted indications. A newer rationale is to enhance the efficacy of radiation therapy and/or chemotherapy in controlling tumors. A laboratory animal study found that administration of recombinant human erythropoietin (rHuEPO) increased intratumoral median oxygen levels and diminished the proportion of measurements in the very low (<3 mm Hg) range. Hemoglobin level is a strong independent prognostic factor for tumor control by radiation therapy. The hemoglobin level at the end of radiation therapy is a stronger prognostic factor than is the hemoglobin level at the start of therapy. Numerous clinical trials have utilized rHuEPO during radiation with or without concurrent chemotherapy. All 4 trials which enrolled patients with low hemoglobin levels (<12 to 13.5 g/dl) found that rHuEPO significantly increased hemoglobin within 2 weeks and that hemoglobin levels continued to rise until the end of rHuEPO treatment. rHuEPO was efficacious in limiting the decrease in hemoglobin and use of packed red blood cell transfusion in the one reported trial in which it was used in patients with initially normal hemoglobin levels during intensive concurrent radiation and chemotherapy. One trial found a statistically significant improvement in complete pathologic response rate after neoadjuvant chemoradiotherapy with the use of rHuEPO. rHuEPO has a potentially large role to play in the care of the cancer patient. (orig.)

  19. 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...... during the three case studies is very encouraging and calls for additional reports of UX evaluations involving drawing- and theatre-based exercises....

  20. 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

  1. 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…

  2. Clinical trial experience using erythropoietin during radiation therapy

    Energy Technology Data Exchange (ETDEWEB)

    Lavey, R.S. [Radiation Oncology Program, Childrens Hospital Los Angeles, Univ. of Southern California, CA, Los Angeles (United States)

    1998-12-01

    Oncologists have several reasons for trying to maintain or increase hemoglobin levels in their patients during therapy. Relief of the symptoms of anemia, including fatigue and dyspnea, are traditional, well-accepted indications. A newer rationale is to enhance the efficacy of radiation therapy and/or chemotherapy in controlling tumors. A laboratory animal study found that administration of recombinant human erythropoietin (rHuEPO) increased intratumoral median oxygen levels and diminished the proportion of measurements in the very low (<3 mm Hg) range. Hemoglobin level is a strong independent prognostic factor for tumor control by radiation therapy. The hemoglobin level at the end of radiation therapy is a stronger prognostic factor than is the hemoglobin level at the start of therapy. Numerous clinical trials have utilized rHuEPO during radiation with or without concurrent chemotherapy. All 4 trials which enrolled patients with low hemoglobin levels (<12 to 13.5 g/dl) found that rHuEPO significantly increased hemoglobin within 2 weeks and that hemoglobin levels continued to rise until the end of rHuEPO treatment. rHuEPO was efficacious in limiting the decrease in hemoglobin and use of packed red blood cell transfusion in the one reported trial in which it was used in patients with initially normal hemoglobin levels during intensive concurrent radiation and chemotherapy. One trial found a statistically significant improvement in complete pathologic response rate after neoadjuvant chemoradiotherapy with the use of rHuEPO. rHuEPO has a potentially large role to play in the care of the cancer patient. (orig.) [Deutsch] In der Onkologie bestehen zahlreiche Gruende, die Haemoglobinkonzentration der Patienten waehrend der Therapie zu halten oder sogar anzuheben. Als anerkannte Indikation gilt hierbei die Besserung anaemiebedingter Symptome wie Muedigkeit und Dyspnoe, wobei jedoch neuere Ergebnisse darauf hinweisen, dass auch die Effizienz der Strahlen- und

  3. Long-Acting Injectable Antipsychotics for Prevention of Relapse in Bipolar Disorder: A Systematic Review and Meta-Analyses of Randomized Controlled Trials

    Science.gov (United States)

    Oya, Kazuto; Iwata, Nakao

    2016-01-01

    Background: This meta-analysis of randomized controlled trials aimed to examine the advantages of long-acting injectable antipsychotics over placebo or oral medications regarding efficacy and safety for patients with bipolar disorder. Methods: Two categorical meta-analyses of randomized controlled trials were performed to compare study-defined relapse rate (primary), discontinuation rates, and individual adverse events: (1) risperidone-long-acting injectable vs placebo, and (2) long-acting injectable antipsychotics vs oral medications. Results: We identified 7 randomized controlled trials (n=1016; long-acting injectable antipsychotics [flupenthixol (1 randomized controlled trial) and risperidone (6 randomized controlled trials)=449]; oral medications [mood stabilizers, antidepressants, antipsychotic, or any combination of these agents=283]; and placebo=284). Risperidone-long-acting injectable antipsychotic was superior to placebo for study-defined relapse rate (risk ratio=0.63, Psymptoms (risk ratio=0.42, Pprevention in patients with rapid cycling. Furthermore, randomized controlled trials comparing long-acting injectable antipsychotics and oral second-generation antipsychotic using larger samples of rapid cycling patients are warranted. PMID:27207910

  4. An online guided ACT intervention for enhancing the psychological wellbeing of university students: A randomized controlled clinical trial.

    Science.gov (United States)

    Räsänen, Panajiota; Lappalainen, Päivi; Muotka, Joona; Tolvanen, Asko; Lappalainen, Raimo

    2016-03-01

    Stress, anxiety and depression are relatively common problems among university students. This study examined whether an online psychological intervention aiming at enhancing the wellbeing of university students could be an effective and practical alternative for meeting the needs of a university population. University students (N = 68; 85% female; 19-32 years old) were randomly assigned to either a guided seven-week online Acceptance and Commitment Therapy (iACT) intervention or a waiting list control condition (WLC). A between-groups pre-post (iACT vs WLC) design with 12-month follow-up for the iACT participants was conducted. The intervention participants were offered two face-to-face meetings, completed online exercises during a five-week period, and received personal weekly written feedback via the website from their randomly assigned, trained student coaches. Waitlist participants were offered the intervention program soon after the post measurements. Results in this small efficacy trial showed that the iACT participants had significantly higher gains in wellbeing (between group, d = 0.46), life satisfaction (d = 0.65), and mindfulness skills (d = 0.49). In addition, iACT participants' self-reported stress (d = 0.54) and symptoms of depression (d = 0.69) were significantly reduced compared to the participants in the control group. These benefits were maintained over a 12-month follow-up period (within iACT group, d = 0.65-0.69, for primary measures). The results suggest that an online-based, coach-guided ACT program with blended face-to-face and online sessions could be an effective and well-accepted alternative for enhancing the wellbeing of university students. PMID:26848517

  5. 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

  6. Experiments for Ka-band mobile applications: The ACTS mobile terminal

    Science.gov (United States)

    Estabrook, Polly; Dessouky, Khaled; Jedrey, Thomas

    1990-01-01

    To explore the potential of Ka-band to support mobile satellite services, the Jet Propulsion Laboratory (JPL) has initiated the design and development of a Ka-band land-mobile terminal to be used with the Advanced Communications Technology Satellite (ACTS). The planned experimental setup with ACTS is described. Brief functional descriptions of the mobile and fixed terminals are provided. The inputs required from the propagation community to support the design activities and the planned experiments are also discussed.

  7. 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…

  8. Long-Acting Injectable Antipsychotics for Prevention of Relapse in Bipolar Disorder: A Systematic Review and Meta-Analyses of Randomized Controlled Trials

    Science.gov (United States)

    Oya, Kazuto; Iwata, Nakao

    2016-01-01

    Background: This meta-analysis of randomized controlled trials aimed to examine the advantages of long-acting injectable antipsychotics over placebo or oral medications regarding efficacy and safety for patients with bipolar disorder. Methods: Two categorical meta-analyses of randomized controlled trials were performed to compare study-defined relapse rate (primary), discontinuation rates, and individual adverse events: (1) risperidone-long-acting injectable vs placebo, and (2) long-acting injectable antipsychotics vs oral medications. Results: We identified 7 randomized controlled trials (n=1016; long-acting injectable antipsychotics [flupenthixol (1 randomized controlled trial) and risperidone (6 randomized controlled trials)=449]; oral medications [mood stabilizers, antidepressants, antipsychotic, or any combination of these agents=283]; and placebo=284). Risperidone-long-acting injectable antipsychotic was superior to placebo for study-defined relapse rate (risk ratio=0.63, P<.0001), relapse of manic symptoms (risk ratio=0.42, P<.00001), and all-cause discontinuation (risk ratio=0.75, P=.007). Risperidone-long-acting injectable was associated with higher incidence of prolactin-related adverse events (risk ratio=4.82, P=.001) and weight gain (risk ratio=3.80, P<.0001) than placebo. The pooled long-acting injectable antipsychotics did not outperform oral medications regarding primary outcome but with significant heterogeneity (I2=74%). Sensitivity analysis, including only studies with rapid cycling or high frequency of relapse patients, revealed that long-acting injectable antipsychotics were superior compared to oral medications (I2=0%, RR=0.58, P=.0004). However, the comparators in this sensitivity analysis did not include second-generation antipsychotic monotherapy. In sensitivity analysis, including only studies with second-generation antipsychotic monotherapy as the comparator, long-acting injectable antipsychotics did not outperform second

  9. A six month randomized controlled trial of long acting injectable risperidone 50 and 100mg in treatment resistant schizophrenia.

    Science.gov (United States)

    Meltzer, H Y; Lindenmayer, J-P; Kwentus, J; Share, D B; Johnson, R; Jayathilake, K

    2014-04-01

    It has been suggested that atypical antipsychotic drugs (A-APDs) other than clozapine may be effective to improve positive symptoms in some patients with treatment resistant schizophrenia (TRS), if both the dose is higher, and the duration of the trial longer, than those which have been ineffective in non-TRS (NTRS) patients. This hypothesis was tested with long acting injectable risperidone (Risperdal Consta®, RLAI). One hundred sixty TRS patients selected for persistent moderate-severe delusions or hallucinations, or both, were randomized to RLAI, 50 or 100mg biweekly, in a six month, outpatient, double-blind, multicenter trial. We hypothesized that RLAI, 100mg, would be more effective than RLAI, 50mg. However, both doses produced clinically significant and equivalent improvement in PANSS Total, Positive, and Negative subscale scores, as well as key cognitive, global and functional measures, with increasing response during the course of the study, confirming the value of longer clinical trial duration for patients with TRS, but not superiority of the higher dose. The overall response rate was comparable to that previously reported for clozapine and high dose olanzapine, another A-APD, in TRS. Both doses of RLAI were equally well tolerated, producing minimal extrapyramidal side effects and few drop outs. Plasma levels of the active moiety, risperidone+9-hydroxyrisperidone, during treatment with RLAI 100mg, were comparable to those for 6-8 mg/day oral risperidone, which have not been effective in TRS. Further study of RLAI, ≥ 50-100mg biweekly, should compare it with clozapine and oral risperidone in TRS, with duration of treatment ≥ six months. PMID:24630262

  10. 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.

  11. A comparison of a laboratory scale experiment with a field trial treatment using chlorpyrifos-methyl

    International Nuclear Information System (INIS)

    An experiment was carried out in which a field treatment of a small bulk of grain with chlorpyrifos-methyl was compared with a laboratory treatment of 1 kg of grain with 14C radiolabelled chlorpyrifos-methyl. The conditions under which the grain was maintained in the laboratory mimicked those of the field trial as closely as possible, with sampling and analysis being carried out at the same time and in a similar manner in both. The results from the two experiments were in general agreement with approx. 60% of the chlorpyrifos-methyl remaining intact at the end. A satisfactory level of biological control was achieved in the field trial. The use of the radio-label enabled more information about the fate of the degraded insecticide to be obtained from the laboratory experiment. The majority of this radioactivity comprised a fraction which remained within the grain tissue after solvent extraction. The level of activity in the grain tissues gradually increased with time but its nature is as yet unknown. The good agreement obtained between the residue profile and the breakdown patterns in both experiments would suggest that a laboratory scale experiment is a satisfactory model for the situation pertaining in a large scale field trial. (author)

  12. Recruitment of ethnic minorities into cancer clinical trials: experience from the front lines.

    Science.gov (United States)

    Symonds, R P; Lord, K; Mitchell, A J; Raghavan, D

    2012-09-25

    Throughout the world there are problems recruiting ethnic minority patients into cancer clinical trials. A major barrier to trial entry may be distrust of research and the medical system. This may be compounded by the regulatory framework governing research with an emphasis on written consent, closed questions and consent documentation, as well as fiscal issues. The Leicester UK experience is that trial accrual is better if British South Asian patients are approached by a senior doctor rather than someone of perceived lesser hierarchical status and a greater partnership between the hospital and General Practitioner may increase trial participation of this particular ethnic minority. In Los Angeles, USA, trial recruitment was improved by a greater utilisation of Hispanic staff and a Spanish language-based education programme. Involvement of community leaders is essential. While adhering to national, legal and ethnical standards, information sheets and consent, it helps if forms can be tailored towards the local ethnic minority population. Written translations are often of limited value in the recruitment of patients with no or limited knowledge of English. In some cultural settings, tape-recorded verbal consent (following approval presentations) may be an acceptable substitute for written consent, and appropriate legislative changes should be considered to facilitate this option. Approaches should be tailored to specific minority populations, taking consideration of their unique characteristics and with input from their community leadership. PMID:23011540

  13. 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.

  14. Implementation of the Adoption and Safe Families Act of 1997: The Indiana Experience

    Directory of Open Access Journals (Sweden)

    Cathleen S. Graham

    2000-05-01

    Full Text Available The Adoption and Safe Families Act of 1997 (ASFA is expected to have a profound impact on children and families the child welfare system serves. This article provides information about Indiana’s experience in implementing ASFA, including policy decisions made by the legislative and executive branches of government and the involvement of the judiciary. A multidisciplinary task force addressed training and program needs for positive implementation. Initial outcomes for Indiana children and remaining challenges are discussed.

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

    OpenAIRE

    Chaoying Tang; Craig R. Seal; 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...

  16. 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.

  17. 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)

  18. 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.

  19. 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

  20. Review of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act: What can the obstetric community learn from the pediatric experience?

    Science.gov (United States)

    Ren, Zhaoxia; Zajicek, Anne

    2015-11-01

    Children have been called therapeutic orphans as they have been excluded from drug research and new drug development resulting in the lack of proper labels for majority of the drugs for pediatric use. The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) are two legislative mandates to improve pediatric drug labeling. The BPCA legislation authorizes the National Institutes of Health (NIH) to implement research programs through funding clinical trials to study off-patent drugs in pediatric population. Obstetric pharmacology research gaps are in many ways similar to those in pediatrics, including off-label use of common medications, and lack of knowledge of appropriate dosing, safety, and efficacy of drugs. Much research is needed to define mechanisms of disease and drug actions in pregnant women to fill the knowledge gaps. PMID:26455383

  1. 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.

  2. 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

    ... Privacy Act of 1974; System of Records--Evaluation of the Pell Grant Experiments Under the Experimental... entitled ``Evaluation of the Pell Grant Experiments Under the Experimental Sites Initiative--2012'' (18- 13... Experiments Under the Experimental Sites Initiative--2012'' in the subject line of the electronic...

  3. 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

  4. Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers' experiences in a placebo‐controlled trial of duloxetine

    Science.gov (United States)

    Kwakye, Isaac N.; Garner, Matthew; Baldwin, David S.; Bamford, Susan; Pinkney, Verity

    2016-01-01

    Objective The objective of this study was to develop an in‐depth understanding of healthy volunteers' experiences of mental health trials. Methods A qualitative study was nested within a healthy volunteer placebo‐controlled trial of duloxetine, a psychotropic drug used for treating patients with major depression and generalized anxiety disorder. Eight participants were interviewed, and data were analyzed using interpretative phenomenological analysis. Results Interviewees described volunteering for the trial because they were interested in research, wanted the monetary incentive, wanted to help researchers, and wanted to be part of something. On entering the trial, participants considered the possible risks and described feeling anxious, excited, and determined; they had some clear expectations and some loosely held hopes about what would happen. During the trial, participants were curious about whether they were taking duloxetine or placebo, self‐monitored their bodies' reactions, and guessed which treatment they received. On being un‐blinded to treatment allocation after completing the trial, some participants' guesses were confirmed, but others were surprised, and a few were disappointed. Conclusions Small changes to advertising/consent materials to reflect volunteers' motivations could improve recruitment rates to similar trials; “active” placebos might be particularly useful for maintaining blinding in healthy volunteer trials; and sensitive procedures are needed for un‐blinding participants to treatment allocation. © 2016 The Authors. Human Psychopharmacology: Clinical and Experimental published by John Wiley & Sons, Ltd. PMID:27378326

  5. 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.

  6. Switching NSAIDs in practice: insights from the Previcox (firocoxib) Experience Trial.

    Science.gov (United States)

    Ryan, William G; Moldave, Katherine; Carithers, Doug

    2007-01-01

    Veterinarians currently have a choice of six registered NSAIDs for use in the management of canine osteoarthritis. There is a need for data to clarify whether there is an increased risk of side effects occurring in the event of a switch between different members of the NSAID class. In this retrospective analysis of extensive data collected in the 1,000 dog Previcox (firocoxib, Merial) Experience Trial, the incidence of side effects in dogs reported as treated with an NSAID 7 days or less before enrollment was compared with that in dogs reported as not having received an NSAID in the equivalent period. Statistical analysis of the data indicates that observation of an interval of up to 1 week between beginning treatment with firocoxib and cessation of treatment with a different NSAID was not associated with any increased risk of adverse events. PMID:18183545

  7. Comparison of Subjective Experiences and Effectiveness of First-Generation Long-Acting Injectable Antipsychotics and Risperidone Long-Acting Injectables in Patients With Schizophrenia.

    Science.gov (United States)

    Chen, Wen-Yin; Lin, Shih-Ku

    2016-10-01

    We conducted a cross-sectional study to compare the subjective experiences and clinical effects of first-generation long-acting injectable (FGA-LAI) antipsychotics with those of risperidone long-acting injectables (RIS-LAIs) in 434 schizophrenia patients. Compared with the RIS-LAI group, the patients treated with FGA-LAIs had a significantly longer duration of illness and LAI treatment and were older. Our results suggest that patients treated with FGA-LAI have more satisfactory subjective experiences compared with patients treated with RIS-LAI and that both FGA-LAI and RIS-LAI treatments can prevent relapses and hospitalization. Additional longitudinal studies determining the long-term benefits of RIS-LAI are warranted. PMID:27580495

  8. The Danish patient safety experience: the Act on Patient Safety in the Danish health care system

    OpenAIRE

    Mette Lundgaard; Louise Raboel; Elisabeth Broegger Jensen; Jacob Anhoej; Beth Lilja Pedersen; Danish Society for Patient Safety

    2005-01-01

    This paper describes the process that lead to the passing of the Act for Patient Safety in the Danish health care system, 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 communicate the learning nationally.

    The act protects health care providers from sanctions as a re...

  9. 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...

  10. 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

  11. What determines patient preferences for treating low risk basal cell carcinoma when comparing surgery vs imiquimod? A discrete choice experiment survey from the SINS trial

    OpenAIRE

    Tinelli Michela; Ozolins Mara; Bath-Hextall Fiona; Williams Hywel C

    2012-01-01

    Abstract Background The SINS trial (Controlled Clinical Trials ISRCTN48755084; Eudract No. 2004-004506-24) is a randomised controlled trial evaluating long term success of excisional surgery vs. imiquimod 5% cream for low risk nodular and superficial basal cell carcinoma (BCC). The trial included a discrete choice experiment questionnaire to explore patient preferences of a cream versus surgery for the treatment of their skin cancer. Methods The self-completed questionnaire was administered a...

  12. 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 lacks...... a differentiated perspective on the potential for information transfer from site to producer. An exploration of the variation in stickiness of information, and therefore the complexity of information transfer in clinical trials, is the main aim of this study. To further enrich the model of the dispersed sites......, complementary service issues and usability patterns are all significantly more difficult to transfer in clinical trials than issues related to product functionality....

  13. 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%…

  14. 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...

  15. 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)

  16. Diagnostic criteria and adjudication process both determine published event-rates : The ACTION trial experience

    NARCIS (Netherlands)

    Kirwan, Bridget-Anne; Lubsen, Jacobus; de Brouwer, Sophie; Danchin, Nicolas; Battler, Alexander; de Luna, Antonio Bayes; Dunselman, Peter H. J. M.; Glasser, Stephen; Koudstaal, Peter J.; Sutton, George; van Dalen, Frederik J.; Poole-Wilson, Philip A.

    2007-01-01

    Objective: Few trials report event-adjudication procedures in detail. Using data from the ACTION (A Coronary disease Trial Investigating Outcome with Nifedipine GITS) study, we compared the impact on event-rates of an adjudication strategy based on systematic screening of all reported serious advers

  17. Challenges with participant reimbursement: experiences from a post-trial access study.

    Science.gov (United States)

    Mngadi, Kathryn Therese; Frohlich, Janet; Montague, Carl; Singh, Jerome; Nkomonde, Nelisiwe; Mvandaba, Nomzamo; Ntombeka, Fanelesibonge; Luthuli, Londiwe; Abdool Karim, Quarraisha; Mansoor, Leila

    2015-11-01

    Reimbursement of trial participants remains a frequently debated issue, with specific guidance lacking. Trials combining post-trial access and implementation science may necessitate new strategies and models. CAPRISA 008, a post-trial access study testing the feasibility of using family planning services to rollout a prelicensure HIV prevention intervention, tried to balance the real-life scenario of no reimbursement for attendance at public sector clinics with that of a trial including some visits that focused on research procedures and others that focused on standard of care procedures. A reduced reimbursement was offered for 'standard of care' visits, meant primarily to cover transport costs to and from the clinic only. This impacted negatively on accrual, retention and participant morale, primarily due to the protracted delay in regulatory approval, during which time, the costs of living, including travel costs had increased. Relevant guidelines were reviewed and institutional policy was updated to incorporate the South African National Health Research Ethics Committee guidelines on reimbursement (taking into account participant time, travel and inconvenience). The reimbursement amount for 'standard of care' visits was increased accordingly. The question remains whether a trial that combines post-trial access with implementation science, with clear benefits for the participants and the provision of above standard medical care, should have reimbursement rates that approach those of a proof-of-concept trial, for 'standard of care' visits. PMID:26392172

  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

    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...... 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...... 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...

  19. Long-acting somatostatin analogues provide significant beneficial effect in patients with refractory small bowel angiodysplasia: Results from a proof of concept open label mono-centre trial

    Science.gov (United States)

    Hall, Barry; Breslin, Niall; McNamara, Deirdre

    2015-01-01

    Introduction Small bowel angiodysplasias account for over 50% of causes of small bowel bleeding and carry a worse prognosis than lesions located elsewhere in the gastrointestinal tract. Re-bleeding rates are high even after first-line endoscopic therapy and are associated with high levels of morbidity for affected patients. Small trials of long-acting somatostatin analogues have shown promising results but have not yet been assessed in patients with refractory small bowel disease. Aim The purpose of this study was to assess the effect of long-acting somatostatin analogues in reducing re-bleeding rates and transfusion requirements, and improving haemoglobin levels in patients with refractory small bowel angiodysplasia. Methods Patients with refractory small bowel angiodysplasia were treated with 20 mg of long-acting octreotide for a minimum of three months. Response was assessed according to: rates of re-bleeding, haemoglobin levels, transfusion requirements, and side effects. Results A total of 24 patients were initially treated and 20 received at least three doses. Rates of complete, partial and non-response were 70%, 20% and 10% respectively. Average haemoglobin rates increased from 9.19 g/dl to 11.35 g/dl (p = 0.0027, 95% confidence interval (CI) −3.5 to −1.1) in the group overall and 70% remained transfusion-free after a mean treatment duration of 8.8 months. The rate of adverse events was higher than previously reported at 30%. Conclusion Long-acting somatostatin analogues offer a therapeutic advantage in a significant proportion of patients with small bowel angiodysplasia. With careful patient selection and close observation, a long-acting somatostatin analogue should be considered in all patients with persistent anaemia attributable to refractory disease in conjunction with other standard treatments. PMID:26966525

  20. "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.

  1. 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

  2. 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

  3. Improving biological relevancy of transcriptional biomarkers experiments by applying the MIQE guidelines to pre-clinical and clinical trials.

    Science.gov (United States)

    Dooms, M; Chango, A; Barbour, E; Pouillart, P; Abdel Nour, A M

    2013-01-01

    The "Minimum Information for the Publication of qPCR Experiments" (MIQE [3]) guidelines are very much targeted at basic research experiments and have to our knowledge not been applied to qPCR assays carried out in the context of clinical trials. This report details the use of the MIQE qPCR app for iPhone (App Store, Apple) to assess the MIQE compliance of one clinical and five pre-clinical trials. This resulted in the need to include 14 modifications that make the guidelines more relevant for the assessment of this special type of application. We also discuss the need for flexibility, since while some parameters increase experimental quality, they also require more reagents and more time, which is not always feasible in a clinical setting. PMID:22910527

  4. Evaluation of a Women's Safe Shelter Experience to Teach Internal Medicine Residents About Intimate Partner Violence: A Randomized Controlled Trial

    OpenAIRE

    Brienza, Rebecca S.; Whitman, Laura; Ladouceur, Lynnea; Green, Michael L.

    2005-01-01

    Although intimate partner violence (IPV) remains a major public health problem, physicians often fail to screen female patients. Reported IPV training approaches suffer from weak study designs and limited outcome assessments. We hypothesized that an educational experience for residents at a women's safe shelter would have significantly greater impact on IPV competencies, screening, and care for victims than a workshop seminar alone. In a pre-post randomized controlled trial, we compared resid...

  5. 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

  6. 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

  7. At the Center or the Margin: Massachusetts' Experience under the School-to-Work Opportunities Act.

    Science.gov (United States)

    Diehl, William; Alex, Hoffinger; Weisstein, Ephraim

    2002-01-01

    Describes background for school-to-work effort in Massachusetts, the state's design and implementation of the School-to-Work Opportunities Act (STWOA) of 1994, the local impact of the state's STWOA grant, challenges to making school-to-work a top priority of state education reform strategies to improve student achievement, and state and local…

  8. Environmental life cycle information management and acquisition - first experiences and results from field trials

    Energy Technology Data Exchange (ETDEWEB)

    Bodenhoefer, K.; Schneider, A. [Sony International (Europe) GmbH (SIE), Stuttgart (Germany); Cock, T.; Brooks, A.; Sands, G. [Merloni Elletrodomestici, Stoke-on-Trent (United Kingdom); Allman, L.; Simon, M. [Sheffield Hallam Univ., Sheffield (United Kingdom); Chong, S.K.; Yang, K. [De Montfort Univ., Leicester (United Kingdom); Delannoy, O.; Catanese, B. [Cybernetix, Rousset (France); Mueller, K. [Motorola GmbH, Taunusstein (Germany)

    2004-07-01

    An improved control of product life cycles enables a more sustainable use of resources. In the EU co-funded project ELIMA (Environmental Life Cycle Information Management and Acquisition for Consumer Products) both hard- and software tools are developed to record and manage reliable product life cycle data to improve service/repair and recycling/reuse as well as product design. Field trials with demonstrator products from two categories - consumer electronics and large household appliances - are running until August 2004. Data collection and general analysis is performed with the help of the internet-based ELIMA information management system. This paper describes the applied data acquisition and data management technologies and the field trials in which they are tested. First field trial results are presented both as a general data interpretation and as subsequent customer oriented analysis. Linked to this, user acceptance survey results from UK and Germany and the conclusions drawn are discussed. (orig.)

  9. 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.

  10. 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.

  11. 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.

  12. The Motivations and Experiences of Young Women in a Microbicide Trial in the USA and Puerto Rico.

    Science.gov (United States)

    Giguere, Rebecca; Zimet, Gregory D; Kahn, Jessica A; Dolezal, Curtis; Leu, Cheng-Shiun; Mabragaña, Marina; McGowan, Ian; Carballo-Diéguez, Alex

    2013-09-01

    Young women are an important target group in microbicide research, yet little is known about why they participate and stay in microbicide trials. Our study examined motivations for participating in a Phase I microbicide trial among 61 women ages 18 - 24 years in the continental USA and Puerto Rico. We also examined their perspectives on study participation. Participants underwent a semi-structured in-depth interview in which they were asked about factors that motivated enrollment and their experiences while participating. They also completed a Web-based Computer Assisted Self Interview in which they were asked to rate study burden (1 = low to 4 = high). Factors that motivated enrollment were altruism (29%), compensation (17%), a combination of altruism and compensation (37%) and free medical exams (17%). Factors that encouraged participants to stay in the study were study staff (95%), confirmation of good health (41%), and the opportunity to learn about their bodies (17%). Mean ratings of study burden ranged from 1.83 (having to travel to site) to 2.41 (colposcopy), indicating that participants were not highly bothered by visits or procedures. Although Phase I trials require invasive procedures, participants were not highly bothered by them and recognized them as necessary. Good relationships with staff and clear information about how procedures contribute to study goals may encourage participants to remain in trials. Young women may be motivated to enter microbicide trials by stressing the role they will play in discovering better HIV-prevention methods and highlighting the comprehensive preventive exams they will receive. PMID:24324918

  13. 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

  14. Metabolic implications when employing heavy pre- and post-exercise rapid-acting insulin reductions to prevent hypoglycaemia in type 1 diabetes patients: a randomised clinical trial.

    Directory of Open Access Journals (Sweden)

    Matthew D Campbell

    Full Text Available To examine the metabolic, gluco-regulatory-hormonal and inflammatory cytokine responses to large reductions in rapid-acting insulin dose administered prandially before and after intensive running exercise in male type 1 diabetes patients.This was a single centre, randomised, controlled open label study. Following preliminary testing, 8 male patients (24±2 years, HbA1c 7.7±0.4%/61±4 mmol.l-1 treated with insulin's glargine and aspart, or lispro attended the laboratory on two mornings at ∼08:00 h and consumed a standardised breakfast carbohydrate bolus (1 g carbohydrate.kg-1BM; 380±10 kcal and self-administered a 75% reduced rapid-acting insulin dose 60 minutes before 45 minutes of intensive treadmill running at 73.1±0.9% VO2peak. At 60 minutes post-exercise, patients ingested a meal (1 g carbohydrate.kg-1BM; 660±21 kcal and administered either a Full or 50% reduced rapid-acting insulin dose. Blood glucose and lactate, serum insulin, cortisol, non-esterified-fatty-acids, β-Hydroxybutyrate, and plasma glucagon, adrenaline, noradrenaline, IL-6, and TNF-α concentrations were measured for 180 minutes post-meal.All participants were analysed. All glycaemic, metabolic, hormonal, and cytokine responses were similar between conditions up to 60 minutes following exercise. Following the post-exercise meal, serum insulin concentrations were lower under 50% (p<0.05 resulting in 75% of patients experiencing hyperglycaemia (blood glucose ≥8.0 mmol.l-1; 50% n = 6, Full n = 3. β-Hydroxybutyrate concentrations decreased similarly, such that at 180 minutes post-meal concentrations were lower than rest under Full and 50%. IL-6 and TNF-α concentrations remained similar to fasting levels under 50% but declined under Full. Under 50% IL-6 concentrations were inversely related with serum insulin concentrations (r = -0.484, p = 0.017.Heavily reducing rapid-acting insulin dose with a carbohydrate bolus before, and a meal after intensive

  15. 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.

  16. Field trial experiment over 1200 km on a 100GHz grid-aligned multi-channel black-box wavelength converter

    OpenAIRE

    Rancaño, V.J.F.; Parmigiani, F.; Petropoulos, P.; Richardson, D. J.

    2013-01-01

    A flexible modulation-, bit rate- independent and polarization insensitive wavelength converter based on a highly nonlinear fiber is demonstrated in the middle-point of a field trial transmission experiment.

  17. 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. PMID:22514795

  18. Improved strategies for designing lupus trials with targeted therapies: learning from 65 years of experience.

    Science.gov (United States)

    Wallace, D J

    2016-09-01

    The development of new agents to manage lupus erythematosus has lagged behind other autoimmune rheumatic diseases. This is in large part because lupus is a heterogeneous disorder affecting nine principal domains (organ systems) that are difficult to measure and quantify and can be at variance with each other. Over the last two decades, a variety of guidelines, definitions, candidate surrogate or biomarkers, metrics and composite indices have been presented as benchmarks that can be utilized to assess lupus in clinical trials. Despite this, over 20 agents have failed to achieve their primary outcome measure, some of which are generally believed to be clinically effective. This article presents constructive suggestions and improved strategies in trial design that will hopefully lead to the introduction of new agents for the disease. PMID:27497258

  19. Experience and challenges from clinical trials with malaria vaccines in Africa.

    Science.gov (United States)

    Mwangoka, Grace; Ogutu, Bernhards; Msambichaka, Beverly; Mzee, Tutu; Salim, Nahya; Kafuruki, Shubis; Mpina, Maxmillian; Shekalaghe, Seif; Tanner, Marcel; Abdulla, Salim

    2013-01-01

    Malaria vaccines are considered amongst the most important modalities for potential elimination of malaria disease and transmission. Research and development in this field has been an area of intense effort by many groups over the last few decades. Despite this, there is currently no licensed malaria vaccine. Researchers, clinical trialists and vaccine developers have been working on many approached to make malaria vaccine available.African research institutions have developed and demonstrated a great capacity to undertake clinical trials in accordance to the International Conference on Harmonization-Good Clinical Practice (ICH-GCP) standards in the last decade; particularly in the field of malaria vaccines and anti-malarial drugs. This capacity is a result of networking among African scientists in collaboration with other partners; this has traversed both clinical trials and malaria control programmes as part of the Global Malaria Action Plan (GMAP). GMAP outlined and support global strategies toward the elimination and eradication of malaria in many areas, translating in reduction in public health burden, especially for African children. In the sub-Saharan region the capacity to undertake more clinical trials remains small in comparison to the actual need.However, sustainability of the already developed capacity is essential and crucial for the evaluation of different interventions and diagnostic tools/strategies for other diseases like TB, HIV, neglected tropical diseases and non-communicable diseases. There is urgent need for innovative mechanisms for the sustainability and expansion of the capacity in clinical trials in sub-Saharan Africa as the catalyst for health improvement and maintained. PMID:23496910

  20. 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.

  1. Improving recruitment and retention for an online randomized controlled trial: experience from the Youthnet study.

    Science.gov (United States)

    Bull, S S; Vallejos, D; Levine, D; Ortiz, C

    2008-09-01

    The objective of the study was to present recruitment and retention findings for an Internet based HIV prevention trial evaluated using a randomized controlled design among 15-25-year-olds accessing a website on the Internet. We used a combination of automated electronic and personalized approaches to increase and diversify recruitment, verify participant eligibility and increase retention. We posted 3.5 million banner advertisements, 9354 individuals clicked on the advertisement, 8950 completed an eligibility screener and 3298 a baseline survey; we flagged 675 of these as suspicious and enrolled 2623 individuals. Of these, 2082 (79%) completed a follow-up at one-month and 1398 (53%) completed a two-month follow-up. This retention rate is the highest we have seen for an Internet-based HIV-prevention trial. Our procedures can be replicated in other trials. We stress the importance of using a combination of automated and personalized techniques to increase enrollment, verify eligibility and promote retention. PMID:18777217

  2. 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

  3. 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.

  4. 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…

  5. 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.

  6. Experiences from a randomised, controlled trial on cycling to school: does cycling increase cardiorespiratory fitness?

    OpenAIRE

    Børrestad, Line Anita Bjørkelund; Østergaard, Lars; Andersen, Lars Bo; Bere, Elling

    2012-01-01

    Aims: The objective of the present study was to investigate the effect of a 12-week randomised controlled cycling-to-school trial on cardiorespiratory fitness. Methods: A total of 53 10- to 13-year-old children from one public school were included. The children were randomised into either a cycling group or a control group. The cycling group was encouraged to cycle to and from school each day during a period of 12 weeks. Peak oxygen consumption (VO2peak) and anthropometrical data (weight and ...

  7. The Reinforcing Therapist Performance (RTP experiment: Study protocol for a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Godley Mark D

    2010-01-01

    Full Text Available Abstract Background Rewarding provider performance has been recommended by the Institute of Medicine as an approach to improve the quality of treatment, yet little empirical research currently exists that has examined the effectiveness and cost-effectiveness of such approaches. The aim of this study is to test the effectiveness and cost-effectiveness of providing monetary incentives directly to therapists as a method to improve substance abuse treatment service delivery and subsequent client treatment outcomes. Design Using a cluster randomized design, substance abuse treatment therapists from across 29 sites were assigned by site to either an implementation as usual (IAU or pay-for-performance (P4P condition. Participants Substance abuse treatment therapists participating in a large dissemination and implementation initiative funded by the Center for Substance Abuse Treatment. Intervention Therapists in both conditions received comprehensive training and ongoing monitoring, coaching, and feedback. However, those in the P4P condition also were given the opportunity to earn monetary incentives for achieving two sets of measurable behaviors related to quality implementation of the treatment. Outcomes Effectiveness outcomes will focus on the impact of the monetary incentives to increase the proportion of adolescents who receive a targeted threshold level of treatment, months that therapists demonstrate monthly competency, and adolescents who are in recovery following treatment. Similarly, cost-effectiveness outcomes will focus on cost per adolescent receiving targeted threshold level of treatment, cost per month of demonstrated competence, and cost per adolescent in recovery. Trial Registration Trial Registration Number: NCT01016704

  8. 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.

  9. Clinical trial experience with the MitraClip catheter based mitral valve repair system.

    Science.gov (United States)

    Maisano, Francesco; Godino, Cosmo; Giacomini, Andrea; Denti, Paolo; Arendar, Iryna; Buzzatti, Nicola; Canna, Giovanni La; Alfieri, Ottavio; Colombo, Antonio

    2011-12-01

    Severe mitral regurgitation (MR) confers a poor prognosis, in particular for patients with heart failure. Based on the results of the Euro Heart Survey, a large proportion of patients with mitral regurgitation is not referred to surgery and many other patients are rejected for cardiac surgery due to the high surgical risk or co-pathologies. Improving ventricular function with ACE inhibitors, beta-blockers and CRT may reduce mitral regurgitation, but for most patients a mechanical intervention is ultimately preferable. Mitral valve surgery is invasive and requires a long recovery period; therefore, less invasive and effective approaches are highly desirable, particularly in high risk patients. Therefore, new techniques have been recently developed to treat MR with percutaneous approach. The MitraClip device (Abbott Vascular, Menlo Park, CA) is used to treat both functional and degenerative mitral valve regurgitation. Its safety and efficacy has been initially tested in the Endovascular Valve Edge-to-Edge REpair Study (EVEREST), while MitraClip has been compared to surgery in the EVEREST II randomized trial. Besides EVEREST trials, safety and efficacy of the device as well as its health economic value is under evaluation in ongoing registries. Although the field of catheter based management of MR is at an early stage, initial clinical results have demonstrated that catheter based approaches can reduce MR, suggesting there is a great deal of potential for clinical benefit to patients with MR.

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

    International Nuclear Information System (INIS)

    Formal waste management services are not accessible for the majority of primary healthcare clinics on the African continent, and affordable and practicable technology solutions are required in the developing country context. In response, a protocol was established for the first quantitative and qualitative evaluation of relatively low cost small-scale incinerators for use at rural primary healthcare clinics. The protocol comprised the first phase of four, which defined the comprehensive trials of three 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 incinerators, but a panel of experts considered the incinerators to be more acceptable compared to the other waste treatment and disposal options available in under-serviced rural areas. However, the incinerators must be used within a safe waste management programme that provides the necessary resources in the form of collection containers, maintenance support, acceptable energy sources, and understandable operational instructions for the incinerators, whilst minimising the exposure risks to emissions through the correct placement of the units in relation to the clinic and the surrounding communities. On-going training and awareness building are essential in order to ensure that the incinerators are correctly used as a sustainable waste treatment option

  11. Experience of using long-acting testosterone undecanoate in hypogonadism, obesity and metabolic syndrome in men

    OpenAIRE

    R V Rozhivanov

    2013-01-01

    The paper outlines the author's experience on the efficacy and safety of androgen therapy of metabolic syndrome and obesity in men with hypogonadism. The study used testosterone undecanoate therapy that reduced body fat and the severity of the other components of the metabolic syndrome, improved sexual function without causing severe side effects. A number of patients on therapy observed suppression of spermatogenesis, which prevents the use of the drug in the reproductive rehabilitation.

  12. Experience of using long-acting testosterone undecanoate in hypogonadism, obesity and metabolic syndrome in men

    Directory of Open Access Journals (Sweden)

    R V Rozhivanov

    2013-03-01

    Full Text Available The paper outlines the author's experience on the efficacy and safety of androgen therapy of metabolic syndrome and obesity in men with hypogonadism. The study used testosterone undecanoate therapy that reduced body fat and the severity of the other components of the metabolic syndrome, improved sexual function without causing severe side effects. A number of patients on therapy observed suppression of spermatogenesis, which prevents the use of the drug in the reproductive rehabilitation.

  13. 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)

  14. 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.

  15. 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

  16. [New graduate program at UNISINOS: sharing the experience of a pedagogical act].

    Science.gov (United States)

    Mallmann, Marly Terezinha; Daudt, Sônia Isabel Dondonis

    2003-01-01

    In this article we present the process of creation of an innovative proposal for undergraduate teaching, developed by an interdisciplinary group at "Universidade do Vale do Rio dos Sinos--UNISINOS". Besides pointing out the theoretical-epistemological referential supporting this proposal, we will also be discussing the implications some paradigm ruptures have brought to the educational process presently being used at this University. We would like to introduce the reader to the process behind this way of understanding and living the educational practice, as well as to follow the account of an experience a group of teachers has had, when confronted with the task of pondering a new undergraduate program. PMID:14699751

  17. Application of local policy to prevent alcohol problems: experiences from a community trial.

    Science.gov (United States)

    Holder, H D; Reynolds, R I

    1997-06-01

    Alcohol policy conventionally has been established at the national or regional, state and provincial levels. Alcohol policy at any level is not actually limited to the regulation and control of alcohol production, wholesale distribution, and retail sales. There are a number of alternatives for setting alcohol policies within a local community. Building upon existing national and state/provincial laws, policy makers at the community level can set priorities for allocating resources and enforcing laws related to drinking and driving, underage alcohol sales, alcohol serving practices of bars and restaurants and geographical density of alcohol outlets in the community. This paper concludes from the Community Trials Project that policies established at the local level can reduce alcohol problems. PMID:9231451

  18. 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

  19. 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

  20. 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.

  1. 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. PMID:26986618

  2. Effects of soil amendments and EDTA on lead uptake by Chromolaena odorata: greenhouse and field trial experiments.

    Science.gov (United States)

    Tanhan, Phanwimol; Pokethitiyook, Prayad; Kruatrachue, Maleeya; Chaiyarat, Rattanawat; Upatham, Suchart

    2011-10-01

    Greenhouse and field trial experiments were performed to evaluate the use of Chromolaena odorata with various soil amendments for phytoextraction of Pb contaminated soil Pb mine soils contain low amount of nutrients, so the additions of organic (cow manure) and inorganic (Osmocote and NH4NO3 and KCl) fertilizers with EDTA were used to enhance plant growth and Pb accumulation. Greenhouse study showed that cow manure decreased available Pb concentrations and resulted in the highest Pb concentration in roots (4660 mg kg(-1)) and shoots (389.2 mg kg(-1)). EDTA increased Pb accumulation in shoots (17-fold) and roots (11-fold) in plants grown in soil with Osmocote with Pb uptake up to 203.5 mg plant(-1). Application of all fertilizers had no significant effects on relative growth rates of C. odorata. Field trial study showed that C. odorata grown in soil with 99545 mg kg(-1) total Pb accumulated up to 3730.2 and 6698.2 mg kg(-1) in shoots and roots, respectively, with the highest phytoextraction coefficient (1.25) and translocation factor (1.18). These results indicated that C. odorata could be used for phytoextraction of Pb contaminated soil. In addition, more effective Pb accumulation could be enhanced by Osmocote fertilizer. However, the use of EDTA in the field should be concerned with their leaching problems. PMID:21972512

  3. 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…

  4. 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…

  5. 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

  6. 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.

  7. 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.

  8. Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05)

    International Nuclear Information System (INIS)

    Background and purpose: Trans-Tasman Radiation Oncology Group 96.05 is a prospective randomized controlled trial comparing a single 8 Gy with 20 Gy in five fractions of radiotherapy (RT) for neuropathic pain due to bone metastases. This paper summarizes the quality assurance (QA) activities for the first 234 patients (accrual target 270). Materials and methods: Independent audits to assess compliance with eligibility/exclusion criteria and appropriateness of treatment of the index site were conducted after each cohort of approximately 45 consecutive patients. Reported serious adverse events (SAEs) in the form of cord/cauda equina compression or pathological fracture developing at the index site were investigated and presented in batches to the Independent Data Monitoring Committee. Finally, source data verification of the RT prescription page and treatment records was undertaken for each of the first 234 patients to assess compliance with the protocol. Results: Only one patient was found conclusively not to have genuine neuropathic pain, and there were no detected 'geographical misses' with RT fields. The overall rate of detected infringements for other eligibility criteria over five audits (225 patients) was 8% with a dramatic improvement after the first audit. There has at no stage been a statistically significant difference in SAEs by randomization arm. There was a 22% rate of RT protocol variations involving ten of the 14 contributing centres, although the rate of major dose violations (more than ±10% from protocol dose) was only 6% with no statistically significant difference by randomization arm (P=0.44). Conclusions: QA auditing is an essential but time-consuming component of RT trials, including those assessing palliative endpoints. Our experience confirms that all aspects should commence soon after study activation

  9. 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. PMID:26514397

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

    Directory of Open Access Journals (Sweden)

    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

  11. Design and conduct of early-phase radiotherapy trials with targeted therapeutics: Lessons from the PRAVO experience

    International Nuclear Information System (INIS)

    New strategies to facilitate the improvement of physical and integrated biological optimization of high-precision treatment protocols are an important priority for modern radiation oncology. From a clinical perspective, as knowledge accumulates from molecular radiobiology, there is a complex and exciting opportunity to investigate novel approaches to rational patient treatment stratification based on actionable tumor targets, together with the appropriate design of next-generation early-phase radiotherapy trials utilizing targeted therapeutics, to formally evaluate relevant clinical and biomarker endpoints. A unique aspect in the development pathway of systemic agents with presumed radiosensitizing activity will also be the need for special attention on patient eligibility and the rigorous definition of radiation dose–volume relationships and potential dose-limiting toxicities. Based on recent experience from systematically investigating histone deacetylase inhibitors as radiosensitizing agents, from initial studies in preclinical tumor models through the conduct of a phase I clinical study to evaluate tumor activity of the targeted agent as well as patient safety and tumor response to the combined treatment modality, this communication will summarize principles relating to early clinical evaluation of combining radiotherapy and targeted therapeutics

  12. 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

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

    OpenAIRE

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

    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

  14. 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…

  15. 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.

  16. 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

  17. What determines patient preferences for treating low risk basal cell carcinoma when comparing surgery vs imiquimod? A discrete choice experiment survey from the SINS trial

    Directory of Open Access Journals (Sweden)

    Tinelli Michela

    2012-10-01

    Full Text Available Abstract Background The SINS trial (Controlled Clinical Trials ISRCTN48755084; Eudract No. 2004-004506-24 is a randomised controlled trial evaluating long term success of excisional surgery vs. imiquimod 5% cream for low risk nodular and superficial basal cell carcinoma (BCC. The trial included a discrete choice experiment questionnaire to explore patient preferences of a cream versus surgery for the treatment of their skin cancer. Methods The self-completed questionnaire was administered at baseline to 183 participants, measuring patients’ strength of preferences when choosing either alternative ‘surgery’ or ‘imiquimod cream’ instead of a fixed ‘current situation’ option (of surgical excision as standard practice in UK. The treatments were described according to: cost, chance of complete clearance, side effects and appearance. Participants had to choose between various scenarios. Analysis was performed using a mixed logit model, which took into account the impact of previous BCC treatment and sample preference variability. Results The analysis showed that respondents preferred ‘imiquimod cream’ to their ‘current situation’ or ‘surgery’, regardless of previous experience of BCC symptoms and treatment. Respondents were more likely to be worried about their cosmetic outcomes and side effects they might experience over and above their chance of clearance and cost. Those with no experience of surgery (compared with experience valued more the choice of ‘imiquimod cream’ (£1013 vs £781. All treatment characteristics were significant determinants of treatment choice, and there was significant variability in the population preferences for all of them. Conclusions Patients with BCC valued more ‘imiquimod cream’ than alternative ‘surgery’ options, and all treatment characteristics were important for their choice of care. Understanding how people with a BCC value alternative interventions may better inform the

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

    OpenAIRE

    Moodley Jothi; Maharaj Rashika; Guddera Vijayanand; Govinden Roshini; Gappoo Sharika; Ganesh Shay; Dladla-Qwabe Nozizwe; Coumi Nicola; Ramjee Gita; Morar Neetha; Naidoo Sarita; Palanee Thesla

    2010-01-01

    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 fr...

  19. Process evaluation of the MOSAIC trial: treatment experience of two psychological therapies for out-patient treatment of Anorexia Nervosa

    OpenAIRE

    Zainal, K. A.; Renwick, B.; Keyes, A.; Lose, A.; Kenyon, M.; DeJong, H; Broadbent, H.; Serpell, L; Richards, L.; Johnson-Sabine, E.; Boughton, N.; Whitehead, L.; Treasure, J; Schmidt, U.; MOSAIC trial group

    2016-01-01

    BACKGROUND: This study is part of a series of process evaluations within the MOSAIC Trial (Maudsley Outpatient Study of Treatments for Anorexia Nervosa and Related Conditions). This randomised controlled trial (RCT) compared two psychological treatments, the Maudsley Model for Treatment of Adults with Anorexia Nervosa (MANTRA) and Specialist Supportive Clinical Management (SSCM) for adult outpatients with Anorexia Nervosa. The present process study integrates quantitative (treatment acceptabi...

  20. Evaluating the impact of the alcohol act on off-trade alcohol sales: a natural experiment in Scotland

    OpenAIRE

    Robinson, Mark; Geue, Claudia; Lewsey, James; MacKay, Daniel; McCartney, Gerry; Curnock, Esther; Beeston, Clare

    2014-01-01

    Background and aims A ban on multi-buy discounts of off-trade alcohol was introduced as part of the Alcohol Act in Scotland in October 2011. The aim of this study was to assess the impact of this legislation on alcohol sales, which provide the best indicator of population consumption. Design Setting and Participants Interrupted time-series regression was used to assess the impact of the Alcohol Act on alcohol sales among off-trade retailers in Scotland. Models accounted for underlyi...

  1. Evaluating the Effectiveness of ACT for Anxiety Disorders in a Self-Help Context: Outcomes From a Randomized Wait-List Controlled Trial.

    Science.gov (United States)

    Ritzert, Timothy R; Forsyth, John P; Sheppard, Sean C; Boswell, James F; Berghoff, Christopher R; Eifert, Georg H

    2016-07-01

    Rigorous evaluations of cognitive behavioral self-help books for anxiety in pure self-help contexts are lacking. The present study evaluated the effectiveness of an Acceptance and Commitment Therapy (ACT) self-help workbook for anxiety-related concerns, with no therapist contact, in an international sample. Participants (N=503; 94% mental health diagnosis) were randomized to an immediate workbook (n=256) or wait-list condition (n=247). Assessments at pretreatment, 12weeks, 6months, and 9months evaluated anxiety and related symptoms, quality of life, and ACT treatment processes (e.g., psychological flexibility). Participants in the wait-list arm crossed over to the workbook following the 12-week assessment. The workbook condition yielded significant improvements on all assessments from pre- to posttreatment relative to wait-list, and these gains were maintained at follow-ups. The pattern observed in the wait-list condition was virtually identical to the active treatment arm after receiving the workbook, but not before. Attrition was notable, but supplemental analyses suggested dropout did not influence treatment effects for all but one measure. Overall, findings provide preliminary support for the effectiveness of this self-help workbook and suggest ACT-based self-help bibliotherapy might be a promising low-cost intervention for people experiencing significant anxiety-related concerns. PMID:27423162

  2. 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

    OpenAIRE

    Nair, Manisha; Ariana, Proochista; Webster, Premila

    2014-01-01

    Objective 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. Setting The study was undertaken in the Dungarpur district of Rajas...

  3. 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

  4. 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

  5. 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

  6. Clinical, Ethical and Financial Implications of Incidental Imaging Findings: Experience from a Phase I Trial in Healthy Elderly Volunteers

    OpenAIRE

    Pinato, D J; Stavraka, C.; Tanner, M.; Esson, A.; Jacobson, E. W.; Wilkins, M. R.; Libri, V.

    2012-01-01

    Background The detection of incidental findings (IF) in magnetic resonance imaging (MRI) studies is common and increases as a function of age. Responsible handling of IF is required, with implications for the conduct of research and the provision of good clinical care. Aim To investigate the prevalence and clinical significance of IF in a prospective cohort of healthy elderly volunteers who underwent MRI of the torso as a baseline investigation for a phase I trial. We assessed the ...

  7. Community perceptions of repeat HIV-testing: experiences of the ANRS 12249 Treatment as Prevention trial in rural South Africa.

    Science.gov (United States)

    Orne-Gliemann, Joanna; Zuma, Thembelihle; Chikovore, Jeremiah; Gillespie, Natasha; Grant, Merridy; Iwuji, Collins; Larmarange, Joseph; McGrath, Nuala; Lert, France; Imrie, John

    2016-01-01

    In the context of the ANRS 12249 Treatment as Prevention (TasP) trial, we investigated perceptions of regular and repeat HIV-testing in rural KwaZulu-Natal (South Africa), an area of very high HIV prevalence and incidence. We conducted two qualitative studies, before (2010) and during the early implementation stages of the trial (2013-2014), to appreciate the evolution in community perceptions of repeat HIV-testing over this period of rapid changes in HIV-testing and treatment approaches. Repeated focus group discussions were organized with young adults, older adults and mixed groups. Repeat and regular HIV-testing was overall well perceived before, and well received during, trial implementation. Yet community members were not able to articulate reasons why people might want to test regularly or repeatedly, apart from individual sexual risk-taking. Repeat home-based HIV-testing was considered as feasible and convenient, and described as more acceptable than clinic-based HIV-testing, mostly because of privacy and confidentiality. However, socially regulated discourses around appropriate sexual behaviour and perceptions of stigma and prejudice regarding HIV and sexual risk-taking were consistently reported. This study suggests several avenues to improve HIV-testing acceptability, including implementing diverse and personalised approaches to HIV-testing and care, and providing opportunities for antiretroviral therapy initiation and care at home. PMID:27421048

  8. -ctgov-: A suite of Stata commands for reporting trial results to ClinicalTrials.gov

    OpenAIRE

    Phil Schumm; Theodore Karrison

    2014-01-01

    In response to the 1997 Food and Drug Administration Modernization Act (FDAMA), the National Institutes of Health (NIH) established ClinicalTrials.gov, an online, publicly-accessible registry for clinical trials. The 2007 Food and Drug Administration Amendments Act (FDAAA) broadened the scope of eligible trials, added outcomes reporting as a requirement, and established penalties for non-compliance. Although ClinicalTrials.gov increased the transparency with which clinical trials are conducte...

  9. Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial.

    Science.gov (United States)

    Santagostino, Elena; Martinowitz, Uri; Lissitchkov, Toshko; Pan-Petesch, Brigitte; Hanabusa, Hideji; Oldenburg, Johannes; Boggio, Lisa; Negrier, Claude; Pabinger, Ingrid; von Depka Prondzinski, Mario; Altisent, Carmen; Castaman, Giancarlo; Yamamoto, Koji; Álvarez-Roman, Maria-Teresa; Voigt, Christine; Blackman, Nicole; Jacobs, Iris

    2016-04-01

    A global phase 3 study evaluated the pharmacokinetics, efficacy, and safety of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in 63 previously treated male patients (12-61 years) with severe hemophilia B (factor IX [FIX] activity ≤2%). The study included 2 groups: group 1 patients received routine prophylaxis once every 7 days for 26 weeks, followed by either 7-, 10-, or 14-day prophylaxis regimen for a mean of 50, 38, or 51 weeks, respectively; group 2 patients received on-demand treatment of bleeding episodes for 26 weeks and then switched to a 7-day prophylaxis regimen for a mean of 45 weeks. The mean terminal half-life of rIX-FP was 102 hours, 4.3-fold longer than previous FIX treatment. Patients maintained a mean trough of 20 and 12 IU/dL FIX activity on prophylaxis with rIX-FP 40 IU/kg weekly and 75 IU/kg every 2 weeks, respectively. There was 100% reduction in median annualized spontaneous bleeding rate (AsBR) and 100% resolution of target joints when subjects switched from on-demand to prophylaxis treatment with rIX-FP (P< .0001). The median AsBR was 0.00 for all prophylaxis regimens. Overall, 98.6% of bleeding episodes were treated successfully, including 93.6% that were treated with a single injection. No patient developed an inhibitor, and no safety concerns were identified. These results indicate rIX-FP is safe and effective for preventing and treating bleeding episodes in patients with hemophilia B at dosing regimens of 40 IU/kg weekly and 75 IU/kg every 2 weeks. This trial was registered atwww.clinicaltrials.govas #NCT0101496274. PMID:26755710

  10. Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial

    Science.gov (United States)

    Martinowitz, Uri; Lissitchkov, Toshko; Pan-Petesch, Brigitte; Hanabusa, Hideji; Oldenburg, Johannes; Boggio, Lisa; Negrier, Claude; Pabinger, Ingrid; von Depka Prondzinski, Mario; Altisent, Carmen; Castaman, Giancarlo; Yamamoto, Koji; Álvarez-Roman, Maria-Teresa; Voigt, Christine; Blackman, Nicole; Jacobs, Iris

    2016-01-01

    A global phase 3 study evaluated the pharmacokinetics, efficacy, and safety of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in 63 previously treated male patients (12-61 years) with severe hemophilia B (factor IX [FIX] activity ≤2%). The study included 2 groups: group 1 patients received routine prophylaxis once every 7 days for 26 weeks, followed by either 7-, 10-, or 14-day prophylaxis regimen for a mean of 50, 38, or 51 weeks, respectively; group 2 patients received on-demand treatment of bleeding episodes for 26 weeks and then switched to a 7-day prophylaxis regimen for a mean of 45 weeks. The mean terminal half-life of rIX-FP was 102 hours, 4.3-fold longer than previous FIX treatment. Patients maintained a mean trough of 20 and 12 IU/dL FIX activity on prophylaxis with rIX-FP 40 IU/kg weekly and 75 IU/kg every 2 weeks, respectively. There was 100% reduction in median annualized spontaneous bleeding rate (AsBR) and 100% resolution of target joints when subjects switched from on-demand to prophylaxis treatment with rIX-FP (P < .0001). The median AsBR was 0.00 for all prophylaxis regimens. Overall, 98.6% of bleeding episodes were treated successfully, including 93.6% that were treated with a single injection. No patient developed an inhibitor, and no safety concerns were identified. These results indicate rIX-FP is safe and effective for preventing and treating bleeding episodes in patients with hemophilia B at dosing regimens of 40 IU/kg weekly and 75 IU/kg every 2 weeks. This trial was registered at www.clinicaltrials.gov as #NCT0101496274. PMID:26755710

  11. Working Experience and Practice in Field Trials of Pesticides%农药田间药效试验工作的经验及做法

    Institute of Scientific and Technical Information of China (English)

    宋烨华

    2012-01-01

    Field trials of pesticides are different from the general demonstration and simple effect observation They are the important workthat the country in order to ensure pesticide can control biological effect and be safe to crops and environment before pesticide entering the market. Field trials of pesticides need to evaluate their control effects, negative effects and environmental effects, and to provide data of registrations for pesticide enterprises and pesticide extension. As a result of efficacy trials of pesticide by natural conditions, the agricultural conditions, test the improper operation and other factorsled to the inaccuracy of the test data and the incomparability of prone. In order to ensure the accuracy and efficacy of pesticide trials, the experience and measures of field trials for pesticide were summed up based on many years of practicing experience.%农药田间药效试验有别于一般防治示范或简单的效果观察。它是农药在进入市场之前,国家为保证农药对有害生物的防治效果和对作物及环境的安全性而开展的一项重要工作。农药田间药效试验需要对农药产品防治效果、负面效应以及环境影响作出客观、公正的综合评价,为农药生产企业办理农药登记提供资料,为农药推广应用提供科学依据。为保证农药田间药效试验的准确性和对试验药剂进行客观合理的分析、评价,笔者通过多年的实践经历,总结了做好农药田间药效试验经验以及具体做法。

  12. Understanding experiences of participating in a weight loss lifestyle intervention trial: a qualitative evaluation of South Asians at high risk of diabetes

    Science.gov (United States)

    Morrison, Zoe; Douglas, Anne; Bhopal, Raj; Sheikh, Aziz

    2014-01-01

    Objective To explore the reasons for enrolling, experiences of participating and reasons for remaining in a family-based, cluster randomised controlled trial of a dietitian-delivered lifestyle modification intervention aiming to reduce obesity in South Asians at high risk of developing diabetes. Design Qualitative study using narrative interviews of a purposive sample of trial participants following completion of the intervention. Data were thematically analysed. Setting The intervention was conducted in Scotland and resulted in a modest decrease in weight, but did not statistically reduce the incidence of diabetes. Participants We conducted 21 narrative interviews with 24 participants (20 trial participants and four family volunteers). Results Many participants were motivated to participate because of: known family history of diabetes and the desire to better understand diabetes-related risks to their own and their family's health; ways to mitigate these risks and to benefit from personalised monitoring. Home-based interventions, communication in the participant's chosen language(s) and continuity in dietitians supported their continuing engagement with the trial. Adaptations in food choices were initially accommodated by participants, although social and faith-based responsibilities were reported as important barriers to persevering with agreed dietary goals. Many participants reported that increasing their level of physical activity was difficult given their long working hours, physically demanding employment and domestic commitments; this being compounded by Scotland's challenging climate and a related reluctance to exercise in the outdoors. Conclusions Although participants had strong personal interests in participation and found the information provided by dietitians useful, they nonetheless struggled to incorporate the dietary and exercise recommendations into their daily lives. In particular, increasing levels of physical exercise was described as an

  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

    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

  14. 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

  15. 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.

  16. 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. PMID:27430546

  17. The experience of becoming a grandmother to a premature infant - A balancing act, influenced by ambivalent feeling

    OpenAIRE

    Hollman Frisman, Gunilla; Eriksson, Carrie; Pernehed, Sara; Mörelius, Evalotte

    2012-01-01

    Aims and objectives.  To explore and describe the experience of becoming a grandmother to a premature infant. Background.  Becoming a grandmother involves a new perspective of life. Grandmothers of sick infants find themselves in a new situation with an adult child undergoing serious stress. Few studies have approached the grandmothers’ own experience of becoming a grandmother to a premature infant. Design.  A qualitative content analysis was used. Methods.  Eleven women, 52–66 years of age, ...

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

    International Nuclear Information System (INIS)

    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. 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. 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. 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. NCT00953394

  19. 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.

  20. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study

    OpenAIRE

    Prayle, A.P.; Hurley, M.N.; Smyth, Alan R

    2012-01-01

    Objective To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation. Design Registry based study of clinical trial summaries. Data sources ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one...

  1. 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.

  2. 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.

  3. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical Trial Informed ... for more information Scientists usually do years of experiments in the laboratory and in animals before they even consider testing an experimental treatment ...

  4. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical Trial Informed ... years of experiments in the laboratory and in animals before they even ... this early research occurs at universities and medical centers across the ...

  5. A balancing act: a phenomenological exploration of medical students' experiences of using mobile devices in the clinical setting

    Science.gov (United States)

    Rashid-Doubell, F; Mohamed, S; Elmusharaf, K; O'Neill, C S

    2016-01-01

    Objective The aims of this study were to describe the experiences of senior students using mobile devices in a clinical setting while learning and interacting with clinical teachers, patients and each other, and to identify challenges that facilitated or impeded the use of such devices in the hospital. Design Interpretative phenomenology was chosen to guide our enquiry. Semi-structured interviews were conducted to examine the experiences of five senior medical students using mobile devices in the clinical setting. Setting and participants Senior medical students at an international medical school in the Middle East. Results Three main themes emerged from the data analysis: learning; professional identity and transitioning from student to doctor. The findings showed that using mobile devices in the clinical area as a learning tool was not a formalised process. Rather, it was opportunistic learning at the bedside and on occasion a source of distraction from clinical teaching. Students needed to negotiate relationships between themselves, the clinical teacher and patients in order to ensure that they maintained an acceptable professional image. Participants experienced and negotiated the change from student to doctor making them mindful of using their devices at the bedside. Conclusions Mobile devices are part of daily life for a medical student and there is a need to adapt medical education in the clinical setting, to allow the students to use their devices in a sensitive manner. PMID:27142860

  6. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... radiotherapy. Click for more information Scientists usually do years of experiments in the laboratory and in animals ... term side effects. This phase can last several years. A Phase III trial gathers more information about ...

  7. 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. PMID:27600800

  8. 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.

  9. Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled diabetic retinopathy candesartan trials

    DEFF Research Database (Denmark)

    Porta, M; Hainer, J W; Jansson, S-O;

    2011-01-01

    . We report the experience from DIRECT (DIabetic REtinopathy and Candesartan Trials), three placebo-controlled studies designed to examine the effects of an ARB, candesartan, on diabetic retinopathy. METHODS: Over 4 years or longer, 178 normotensive women with type 1 diabetes (86 randomised......AIMS/HYPOTHESIS: The teratogenic consequences of angiotensin-converting enzyme inhibitors angiotensin receptor blockers (ARBs) during the second and third trimesters of pregnancy are well described. However, the consequences of exposure during the first trimester are unclear, especially in diabetes...... 'sick babies' and one cardiac malformation in the placebo group. CONCLUSIONS/INTERPRETATION: The risk for fetal consequences of ARBs in type 1 diabetes may not be high if exposure is clearly limited to the first trimester. Long-term studies in fertile women can be conducted with ARBs during pregnancy...

  10. 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.

  11. 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

  12. 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....

  13. 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. PMID:26581802

  14. Design and Experiment of FBG-Based Icing Monitoring on Overhead Transmission Lines with an Improvement Trial for Windy Weather

    Directory of Open Access Journals (Sweden)

    Min Zhang

    2014-12-01

    Full Text Available A scheme for monitoring icing on overhead transmission lines with fiber Bragg grating (FBG strain sensors is designed and evaluated both theoretically and experimentally. The influences of temperature and wind are considered. The results of field experiments using simulated ice loading on windless days indicate that the scheme is capable of monitoring the icing thickness within 0–30 mm with an accuracy of ±1 mm, a load cell error of 0.0308v, a repeatability error of 0.3328v and a hysteresis error is 0.026%. To improve the measurement during windy weather, a correction factor is added to the effective gravity acceleration, and the absolute FBG strain is replaced by its statistical average.

  15. Experience with the functional assessment of cancer therapy-lung (FACT-L) in ECOG 4593, a phase II hyperfractionated accelerated radiation therapy (HART) trial

    International Nuclear Information System (INIS)

    PURPOSE: To gain experience in measuring quality of life (QOL) using the FACT-L in patients (pt) with non small cell lung cancer (NSCLC) treated with an altered fractionation regimen, HART, in a Phase II, multiinstitutional ECOG trial. MATERIALS AND METHODS: Version 2 of FACT-L, with 43 questions in 6 subscale categories (8 physical well-being, 8 social/family well-being, 3 relationship with doctor, 6 emotional well-being, 8 functional well-being, 10 lung cancer symptoms), available in English, Spanish and French, was administered by data managers and filled out by pts, independent of physician presence or input. The HART trial enrolled 30 pts, and FACT-L was administered at baseline (tp 1), treatment completion (tp 2) and 4 weeks following therapy (tp 3). (35(43)) FACT-L items were designed to yield a total QOL score with higher values reflective of better QOL; in addition, a FACT-L trial outcome index (TOI) was computed (TOI = physical score + functional score + lung cancer related score), and is considered the most relevant clinical QOL measure. RESULTS: The FACT-L completion rates were: tp 1 - (30(30)) (100%), tp 2 - (29(30)) (97%) and tp 3 - (24(30)) (80%); the mean scores at various time points are summarized in the table below and indicate that FACT-L is responsive to changes over time. The differences in subscales and total scores can be used as a measure of change in QOL resulting from treatment; statistically significant change was noted from baseline to tp 2 for physical, emotional and functional well-being; and from baseline to tp 3 for emotional well-being. The change in TOI score was also evaluated as a function of response and toxicity grade, and no clear association emerged. When assessed as a function of survival (at the time of this analysis, (5(30)) pt were alive, with median survival of 56 weeks), the degradation in QOL was most severe for pt who died early; the mean change in TOI from baseline to tp 3 for pt dying in the first 25 weeks, 25

  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. Results availability for analgesic device, complex regional pain syndrome, and post-stroke pain trials: comparing the RReADS, RReACT, and RReMiT databases

    Science.gov (United States)

    Dufka, Faustine L.; Munch, Troels; Dworkin, Robert H.; Rowbotham, Michael C.

    2015-01-01

    Abstract Evidence-based medicine rests on the assumption that treatment recommendations are robust, free from bias, and include results of all randomized clinical trials. The Repository of Registered Analgesic Clinical Trials search and analysis methodology was applied to create databases of complex regional pain syndrome (CRPS) and central post-stroke pain (CPSP) trials and adapted to create the Repository of Registered Analgesic Device Studies databases for trials of spinal cord stimulation (SCS), repetitive transcranial magnetic stimulation (rTMS), and transcranial direct current stimulation (tDCS). We identified 34 CRPS trials, 18 CPSP trials, 72 trials of SCS, and 92 trials of rTMS/tDCS. Irrespective of time since study completion, 45% of eligible CRPS and CPSP trials and 46% of eligible SCS and rTMS/tDCS trials had available results (peer-reviewed literature, results entered on registry, or gray literature); peer-reviewed publications could be found for 38% and 39%, respectively. Examining almost 1000 trials across a spectrum of painful disorders (fibromyalgia, diabetic painful neuropathy, post-herpetic neuralgia, migraine, CRPS, CPSP) and types of treatment, no single study characteristic consistently predicts unavailability of results. Results availability is higher 12 months after study completion but remains below 60% for peer-reviewed publications. Recommendations to increase results availability include supporting organizations advocating for transparency, enforcing existing results reporting regulations, enabling all primary registries to post results, stating trial registration numbers in all publication abstracts, and reducing barriers to publishing “negative” trials. For all diseases and treatment modalities, evidence-based medicine must rigorously adjust for the sheer magnitude of missing results in formulating treatment recommendations. PMID:25599303

  18. Metabolic changes during a field experiment in a world-class windsurfing athlete: a trial with multivariate analyses.

    Science.gov (United States)

    Resende, Nathália Maria; de Magalhães Neto, Anibal Monteiro; Bachini, Flávio; de Castro, Luis Eduardo Viveiros; Bassini, Adriana; Cameron, L C

    2011-10-01

    Physical exercise affects hematological equilibrium and metabolism. This study evaluated the biochemical and hematological responses of a male world-class athlete in sailing who is ranked among the top athletes on the official ISAF ranking list of windsurfing, class RS:X. The results describe the metabolic adaptations of this athlete in response to exercise in two training situations: the first when the athlete was using the usual training and dietary protocol, and the second following training and nutritional interventions based on a careful analysis of his diet and metabolic changes measured in a simulated competition. The intervention protocol for this study consisted of a 3-month facility-based program using neuromuscular training (NT), aerobic training (AT), and nutritional changes to promote anabolism and correct micronutrient malnutrition. Nutritional and training intervention produced an increase in the plasma availability of branched-chain amino acids (BCAAs), aromatic amino acids (AAAs), alanine, glutamate, and glutamine during exercise. Both training and nutritional interventions reduced ammonemia, uricemia, and uremia. In addition, we are able to correct a significant drop in potassium levels during races by correct supplementation. Due to the uniqueness of this experiment, these results may not apply to other windsurfers, but we nonetheless had the opportunity to characterize the metabolic adaptations of this athlete. We also proposed the importance of in-field metabolic analyses to the understanding, support, and training of world-class elite athletes. PMID:21978397

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

    Science.gov (United States)

    Bellavista, Paolo; Corradi, Antonio; Foschini, Luca; Ianniello, Raffaele

    2015-01-01

    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. PMID:26263985

  20. 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.

  1. 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. PMID:26512012

  2. The integration of the treatment for common mental disorders in primary care: experiences of health care providers in the MANAS trial in Goa, India

    Directory of Open Access Journals (Sweden)

    Kirkwood Betty R

    2011-10-01

    Full Text Available Abstract Background The MANAS trial reported that a Lay Health Counsellor (LHC led collaborative stepped care intervention (the "MANAS intervention" for Common Mental Disorders (CMD was effective in public sector primary care clinics but private sector General Practitioners (GPs did as well with or without the additional counsellor. This paper aims to describe the experiences of integrating the MANAS intervention in primary care. Methods Qualitative semi-structured interviews with key members (n = 119 of the primary health care teams upon completion of the trial and additional interviews with control arm GPs upon completion of the outcome analyses which revealed non-inferiority of this arm. Results Several components of the MANAS intervention were reported to have been critically important for facilitating integration, notably: screening and the categorization of the severity of CMD; provision of psychosocial treatments and adherence management; and the support of the visiting psychiatrist. Non-adherence was common, often because symptoms had been controlled or because of doubt that health care interventions could address one's 'life difficulties'. Interpersonal therapy was intended to be provided face to face by the LHC; however it could not be delivered for most eligible patients due to the cost implications related to travel to the clinic and the time lost from work. The LHCs had particular difficulty in working with patients with extreme social difficulties or alcohol related problems, and elderly patients, as the intervention seemed unable to address their specific needs. The control arm GPs adopted practices similar to the principles of the MANAS intervention; GPs routinely diagnosed CMD and provided psychoeducation, advice on life style changes and problem solving, prescribed antidepressants, and referred to specialists as appropriate. Conclusion The key factors which enhance the acceptability and integration of a LHC in primary care are

  3. Biochar: from laboratory mechanisms through the greenhouse to field trials

    Science.gov (United States)

    Masiello, C. A.; Gao, X.; Dugan, B.; Silberg, J. J.; Zygourakis, K.; Alvarez, P. J. J.

    2014-12-01

    The biochar community is excellent at pointing to individual cases where biochar amendment has changed soil properties, with some studies showing significant improvements in crop yields, reduction in nutrient export, and remediation of pollutants. However, many studies exist which do not show improvements, and in some cases, studies clearly show detrimental outcomes. The next, crucial step in biochar science and engineering research will be to develop a process-based understanding of how biochar acts to improve soil properties. In particular, we need a better mechanistic understanding of how biochar sorbs and desorbs contaminants, how it interacts with soil water, and how it interacts with the soil microbial community. These mechanistic studies need to encompass processes that range from the nanometer to the kilometer scale. At the nanometer scale, we need a predictive model of how biochar will sorb and desorb hydrocarbons, nutrients, and toxic metals. At the micrometer scale we need models that explain biochar's effects on soil water, especially the plant-available fraction of soil water. The micrometer scale is also where mechanistic information is neeed about microbial processes. At the macroscale we need physical models to describe the landscape mobility of biochar, because biochar that washes away from fields can no longer provide crop benefits. To be most informative, biochar research should occur along a lab-greenhouse-field trial trajectory. Laboratory experiments should aim determine what mechanisms may act to control biochar-soil processes, and then greenhouse experiments can be used to test the significance of lab-derived mechanisms in short, highly replicated, controlled experiments. Once evidence of effect is determined from greenhouse experiments, field trials are merited. Field trials are the gold standard needed prior to full deployment, but results from field trials cannot be extrapolated to other field sites without the mechanistic backup provided

  4. 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 ...

  5. 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.

  6. 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. PMID:25127179

  7. Evaluation of clinical trials by Ethics Committees in Germany: Experience of applicants with the review of requests for opinion of the Ethics Committees - results of a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA

    Directory of Open Access Journals (Sweden)

    Russ, Hagen

    2009-07-01

    Full Text Available The review of requests for a positive opinion of the ethics committees (application procedure as a requirement to start a clinical trial in Germany has been completely redesigned with the transposition of EU Directive 2001/20/EC in the 12th Amendment of the German Medicines Act in August 2004. The experience of applicants (sponsors, legal representatives of sponsors in the EU and persons or organizations authorized by the sponsors to make the application, respectively in terms of interactions with the ethics committees in Germany has been positive overall, especially with respect to ethics committee adherence to the statutory timelines applicable for review of requests. However, inconsistencies between ethics committees exist in terms of the form and content of the requirements for application documents and their evaluation.With the objective of further improving both the quality of applications and the evaluation of those applications by ethics committees, a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA was conducted from January to April 2008. Based on reasoned opinions issued by the respective ethics committee in charge of the coordinating principal investigator (coordinating ethics committee, the type and frequency of formal and content-related objections to applications according to § 7 of the German Good Clinical Practice (GCP Regulation were systematically documented, and qualitative and quantitative analyses performed. 21 out of 44 members of the VFA participated in the survey. 288 applications for Phase I–IV studies submitted between January and December 2007 to 40 ethics committees were evaluated.This survey shows that about one in six applications is incomplete and has formal and/or content objections, respectively, especially those that pertain to documents demonstrating the qualification of the investigator and/or suitability of the facilities. These objections are attributable to

  8. 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

  9. 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

    Background 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. Purpose To evaluate the effect of SCE interventions on health worker motivation and experiences with clients. Methods 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. Results 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

  10. 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

  11. Adubação do algodoeiro: XII - Quatro experiências com N, P e K em terra - roxa Fertilizer experiments with cotton: XII- Trials with N, P, and K on "terra-roxa" soils

    Directory of Open Access Journals (Sweden)

    W. Schmidt

    1962-01-01

    Full Text Available Neste trabalho são relatados os resultados de quatro experiências de adubação do algodoeiro em terra-roxa, realizadas nos municípios de Araras, Avaré, Limeira e São Carlos. Tôdas foram instaladas em 1942-43. sendo que a de Araras foi conduzida por quatro anos nos mesmos canteiros. Em esquema fatorial 2x4x3, com seis repetições, foram comparados os níveis 0 e 15 kg/ha de N (salitre do Chile; 0, 30, 60 e 90 kg/ha de P2O5 (superfosfato simples; 0, 25 e 50 kg. ha de K2O (cloreto de potássio. Somente na experiência de Limeira, em solo repetidamente adubado com fósforo nas culturas anteriores, é que as respostas ao nitrogênio e ao potássio foram satisfatórias. Para a pequena reação a êsses elementos nas outras localidades parece terem concorrido a pobreza dos solos em fósforo e o método de aplicação dos adubos: nos sulcos de plantio, ao ser êste efetuado. Em contraste, o efeito principal do fósforo, que foi de apenas + 13% em Limeira, ultrapassou +30% nas demais experiências. As respostas às doses de 30, 60 e 90 kg/ha de P2O5, corresponderam, respectivamente, a +62, +85 e +96% em Araras (médias dos quatro anos, +36, +39 e +48% em São Carlos. +36, +34 e +42% em Avaré e tão somente a +11, +16 e +12% em Limeira. Nesta localidade, o efeito do fósforo foi nulo, quando aplicado sòzinho, mas, em média das três doses, atingiu +18% na presença de nitrogênio + potássio. Nas outras experiências também se notou maior efeito do fósforo na presença dos outros nutrientes. Terminando, os autores sugerem uma revisão nas fórmulas de adubação destinadas às áreas repetidamente adubadas com fósforo.This paper reports the results of four trials located at Araras, Avaré, Limeira, and São Carlos, in the State of São Paulo, to study the effects of N, P and K on "terra-roxa" soils. The responses to N and K were satisfactory only in the Limeira experiment, located on an area repeatedly fertilized with phosphorus in the

  12. Market trials of irradiated chicken

    International Nuclear Information System (INIS)

    The potential market for irradiated chicken breasts was investigated using a mail survey and a retail trial. Results from the mail survey suggested a significantly higher level of acceptability of irradiated chicken than did the retail trial. A subsequent market experiment involving actual purchases showed levels of acceptability similar to that of the mail survey when similar information about food irradiation was provided

  13. Japan nuclear ship sea trial

    Energy Technology Data Exchange (ETDEWEB)

    Yamazaki, Hiroshi; Kitamura, Toshikatus; Mizushima, Toshihiko [Japan Atomic Energy Research Inst., Mutsu, Aomori (Japan). Mutsu Establishment] [and others

    1992-01-01

    The sea trial of the first Japan nuclear Ship `MUTSU` was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author).

  14. Japan nuclear ship sea trial

    Energy Technology Data Exchange (ETDEWEB)

    Yamazaki, Hiroshi; Kitamura, Toshikatus; Mizushima, Toshihiko (Japan Atomic Energy Research Inst., Mutsu, Aomori (Japan). Mutsu Establishment) (and others)

    1992-01-01

    The sea trial of the first Japan nuclear Ship 'MUTSU' was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author).

  15. Japan nuclear ship sea trial

    International Nuclear Information System (INIS)

    The sea trial of the first Japan nuclear Ship 'MUTSU' was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author)

  16. Book Act

    OpenAIRE

    Kivland, Sharon

    2014-01-01

    Book Act was a new project by AMBruno, initiated by Sophie Loss, in which artist book-makers performed and embodied the concept or essence of their books through the medium of film or performance. The exhibition at The Tetley, Leeds, comprised the originating books and corresponding video work, with live performances on Sunday 9 March 2014. Book Act took place during the 17th International Contemporary Artists' Book Fair (7th to 9th March) and the exhibition continued until 26th March 2014.

  17. 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

  18. 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 ...

  19. Handbook for Sponsors; Standards and Procedures for Work-Training Experience Programs under the Economic Opportunity Act of 1964, as Amended.

    Science.gov (United States)

    Manpower Administration (DOL), Washington, DC. Bureau of Work-Training Programs.

    The standards and procedures presented establish the basic rules governing the development and operation of various programs administered by the U.S. Department of Labor, Bureau of Work Programs under the Economic Opportunity Act of 1964, as amended. Basic standards relate to qualification of sponsors, eligibility of enrollees, hours of work,…

  20. Visual scoring of non-cavitated caries lesions and clinical trial efficiency, testing xylitol in caries active adults

    Science.gov (United States)

    Brown, JP; Amaechi, BT; Bader, JD; Gilbert, GH; Makhija, SK; Lozano-Pineda, J; Leo, MC; Chuhe, C; Vollmer, WM

    2013-01-01

    Objectives To better understand the effectiveness of xylitol in caries prevention in adults, and to attempt improved clinical trial efficiency. Methods As part of the Xylitol for Adult Caries Trial (X-ACT), non-cavitated and cavitated caries lesions were assessed in subjects who were experiencing the disease. The trial was a test of the effectiveness of 5 grams/day of xylitol, consumed by dissolving in the mouth five 1 gram lozenges spaced across each day, compared with a sucralose placebo. For this analysis, seeking trial efficiency, 538 subjects aged 21–80, with complete data for four dental examinations were selected from the 691 randomized into the three year trial, conducted at three sites. Acceptable inter and intra examiner reliability before and during the trial was quantified using the kappa statistic. Results The mean annualized non-cavitated plus cavitated lesion transition scores in coronal and root surfaces, from sound to carious favoured xylitol over placebo, during the three cumulative periods of 12, 24, and 33 months, but these clinically and statistically non-significant differences declined in magnitude over time. Restricting the present assessment to those subjects with a higher baseline lifetime caries experience showed possible but inconsistent benefit. Conclusions There was no clear and clinically relevant preventive effect of xylitol on caries in adults with adequate fluoride exposure when non-cavitated plus cavitated lesions were assessed. This conformed to the X-ACT trial result assessing cavitated lesions. Including non-cavitated lesion assessment in this full scale, placebo controlled, multi site, randomized, double blinded clinical trial in adults experiencing dental caries, did not achieve added trial efficiency or demonstrate practical benefit of xylitol. Trial Registration ClinicalTrials.Gov NCT00393055 PMID:24205951

  1. Comparison of published orthopaedic trauma trials following registration in Clinicaltrials.gov

    OpenAIRE

    Gandhi Rajiv; Jan Meryam; Smith Holly N; Mahomed Nizar N; Bhandari Mohit

    2011-01-01

    Abstract Background After the Food and Drug Administration Modernization Act of 1997, the registration of all clinical trials became mandatory prior to publication. Our primary objective was to determine publication rates for orthopaedic trauma trials registered with ClinicalTrials.gov. We further evaluated methodological consistency between registration and publication. Methods We searched Clinical Trials.gov for all trials related to orthopaedic trauma. We excluded active trials and trials ...

  2. 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. PMID:27400465

  3. 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

  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. Montelukast as Add-On Therapy with Inhaled Corticosteroids or Inhaled Corticosteroids and Long-Acting Beta-2-Agonists in the Management of Patients Diagnosed with Asthma and Concurrent Allergic Rhinitis (The RADAR Trial

    Directory of Open Access Journals (Sweden)

    Paul K Keith

    2009-01-01

    Full Text Available OBJECTIVE: To evaluate the effectiveness of montelukast as add-on therapy for patients diagnosed with asthma and concurrent allergic rhinitis who remain uncontrolled while receiving inhaled corticosteroid (ICS monotherapy or ICS/long-acting beta-2-agonist (LABA therapy in a community practice setting.

  6. 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, ...

  7. The CEO's second act.

    Science.gov (United States)

    Nadler, David A

    2007-01-01

    When a CEO leaves because of performance problems, the company typically recruits someone thought to be better equipped to fix what the departing executive couldn't--or wouldn't. The board places its confidence in the new person because of the present dilemma's similarity to some previous challenge that he or she dealt with successfully. But familiar problems are inevitably succeeded by less familiar ones, for which the specially selected CEO is not quite so qualified. More often than not, the experiences, skills, and temperament that yielded triumph in Act I turn out to be unequal to Act II's difficulties. In fact, the approaches that worked so brilliantly in Act I may be the very opposite of what is needed in Act II. The CEO has four choices: refuse to change, in which case he or she will be replaced; realize that the next act requires new skills and learn them; downsize or circumscribe his or her role to compensate for deficiencies; or line up a successor who is qualified to fill a role to which the incumbent's skills and interests are no longer suited. Hewlett-Packard's Carly Fiorina exemplifies the first alternative; Merrill Lynch's Stanley O'Neal the second; Google's Sergey Brin and Larry Page the third; and Quest Diagnostics' Ken Freeman the fourth. All but the first option are reasonable responses to the challenges presented in the second acts of most CEOs' tenures. And all but the first require a power of observation, a propensity for introspection, and a strain of humility that are rare in the ranks of the very people who need those qualities most. There are four essential steps executives can take to discern that they have entered new territory and to respond accordingly: recognition that their leadership style and approach are no longer working; acceptance of others' advice on why performance is faltering; analysis and understanding of the nature of the Act II shift; and, finally, decision and action. PMID:17286076

  8. 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......). 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....

  9. Participating in Clinical Trials

    Medline Plus

    Full Text Available Home > Health topics A-Z > Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks ... centers across the country. The National Institutes of Health funds much of this basic research. Screening Trials ...

  10. 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 ...

  11. A Strategy Anthelmintic Control for Helminthoses of Sheep: Some Experiences in On-Farm Trials in Smallholder Farms in Central Kenya

    International Nuclear Information System (INIS)

    An on-farm in Kenya to evaluate the merits of a strategic drenching regime against the existing control measures showed that it was difficult to get statistically significant sample sizes within individual farms and that differences in farm management existed especially where animals are communally grazed. Consequently, production data were rendered difficult to analyse and interpret. Unlike in on-station trials, it was evident that the large number of smallholder farms (up to 80) that was required for realistic statistical comparisons conflicted with the limits of logistics and funding. The strategic treatment for gastrointestinal nematodes in sheep resulted in lower mean faecal egg counts in treated animals for most of the study period but overall, there was no significant effect of strategic treatment over the existing treatments on FEC, birth weight and growth rates in lambs. Possible approaches in future studies, could include use of clusters of smallholder farms that are far apart in different treatment groups. Commonly grazed flocks can either be excluded completely in such trials or if that method of grazing is predominant, entire village or cleary designated locations could be used in different treatment groups. Even with above, the use of production data (growth rate, off-take, mortality etc) need to be handled with great caution

  12. 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.

  13. Act resilient.

    Science.gov (United States)

    Joseph, Genie; Bice-Stephens, Wynona

    2014-01-01

    Attendees have reported changing from being fearful to serene, from listless to energized, from disengaged to connected, and becoming markedly less anxious in a few weeks. Anecdotally, self-reported stress levels have been reduced by over 50% after just one class. Attendees learn not to be afraid of their feelings by working with emotions in a playful manner. When a person can act angry, but separate himself from his personal story, the emotional energy exists in a separate form that is not attached to specific events, and can be more easily dealt with and neutralized. Attendees are taught to "take out the emotional trash" through expressive comedy. They become less intimated by their own emotional intensity and triggers as they learn how even metaphorical buckets of anger, shame, guilt and hurt can be emotionally emptied. The added benefit is that this is accomplished without the disclosure of personal information of the requirement to reexperience past pain which can trigger its own cascade of stress. PMID:24706248

  14. 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.

  15. 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.

  16. 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.

  17. fatalityCMR: capture-recapture software to correct raw counts of wildlife fatalities using trial experiments for carcass detection probability and persistence time

    Science.gov (United States)

    Peron, Guillaume; Hines, James E.

    2014-01-01

    Many industrial and agricultural activities involve wildlife fatalities by collision, poisoning or other involuntary harvest: wind turbines, highway network, utility network, tall structures, pesticides, etc. Impacted wildlife may benefit from official protection, including the requirement to monitor the impact. Carcass counts can often be conducted to quantify the number of fatalities, but they need to be corrected for carcass persistence time (removal by scavengers and decay) and detection probability (searcher efficiency). In this article we introduce a new piece of software that fits a superpopulation capture-recapture model to raw count data. It uses trial data to estimate detection and daily persistence probabilities. A recurrent issue is that fatalities of rare, protected species are infrequent, in which case the software offers the option to switch to an ‘evidence of absence’ mode, i.e., estimate the number of carcasses that may have been missed by field crews. The software allows distinguishing between different turbine types (e.g. different vegetation cover under turbines, or different technical properties), as well between two carcass age-classes or states, with transition between those classes (e.g, fresh and dry). There is a data simulation capacity that may be used at the planning stage to optimize sampling design. Resulting mortality estimates can be used 1) to quantify the required amount of compensation, 2) inform mortality projections for proposed development sites, and 3) inform decisions about management of existing sites.

  18. “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)

    International Nuclear Information System (INIS)

    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.

  19. '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.

  20. Performance trial experience with Danieli new-generation eddy-current surface inspection system for wire rod mill: the equipment and the results at TRM, Rotherham, England

    Energy Technology Data Exchange (ETDEWEB)

    Battistutto, R. [Instruments and Special Devices Dept. (UTP), Carlo Toso, Danieli Automation, Buttrio, Udine (Italy)

    1999-07-01

    Production flexibility and product quality are key subjects that can significantly influence the competitiveness of a steel-making company; recently, they can even affect its profitable permanence on the market. Danieli Automation, thanks to 25-year experience in automation systems for the rolling mill, can offer their customers effective products and solutions specifically designed and developed for total control on the finished product quality. This target is achieved by optimization of yield, availability of the installations and use of the human resources. Results of the above experience and development is the IIITEST instrumentation product family for in-line surface inspection quality control. (author)

  1. Performance trial experience with Danieli new-generation eddy-current surface inspection system for wire rod mill: the equipment and the results at TRM, Rotherham, England

    International Nuclear Information System (INIS)

    Production flexibility and product quality are key subjects that can significantly influence the competitiveness of a steel-making company; recently, they can even affect its profitable permanence on the market. Danieli Automation, thanks to 25-year experience in automation systems for the rolling mill, can offer their customers effective products and solutions specifically designed and developed for total control on the finished product quality. This target is achieved by optimization of yield, availability of the installations and use of the human resources. Results of the above experience and development is the IIITEST instrumentation product family for in-line surface inspection quality control. (author)

  2. How Do Clinical Trials Work?

    Science.gov (United States)

    ... Trials Clinical Trial Websites How Do Clinical Trials Work? If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  3. 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

  4. Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial

    OpenAIRE

    Maruani, Annabel; Boutron, Isabelle; Baron, Gabriel; Ravaud, Philippe

    2014-01-01

    Objective To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation, to remind them of the legal requirement to post results. Design Cohort embedded pragmatic randomized controlled trial. Setting Trials registered on ClinicalTrials.gov. Participants 190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention (personalized emails s...

  5. 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)

  6. Akteurinnen im Dienst der rassistischen Gemeinschaft. Handlungsräume und Erfahrungen Females Acting in Service of the Racist Community—Domains of Action and Experience

    Directory of Open Access Journals (Sweden)

    Katharina Hoffmann

    2008-03-01

    Full Text Available Sybille Steinbacher hat in ihrem Band Volksgenossinnen Aufsätzen versammelt, in denen die Rolle von Frauen bei der Durchsetzung des Ordnungsmodells „Volksgemeinschaft“ untersucht wird. Gegenstand der analytischen Beschreibungen sind das Selbstverständnis und die Erfahrungsgeschichten von Frauen, die als anerkannte Mitglieder der nationalsozialistischen Gesellschaft Handlungsräume in Anspruch nahmen. Insbesondere in den Kriegsjahren vergrößerten sich Tätigkeitsfelder und Aufstiegschancen für „Volksgenossinnen”. Die Beiträge des Bandes erweitern die bisher noch geringen Kenntnisse über Deutungsmuster und Handlungsweisen einer großen Zahl von so genannten arischen, nicht verfolgten Frauen im Nationalsozialismus.Sybille Steinbacher’s volume Female Comrades (Volksgenossinnen contains essays that examine the role of women during the propagation of the nationalistic structural model of Germany as an “ethnic community.” The subject of the analytical descriptions is the self-conception and historical experience of women, who as recognized members of the national socialist community laid claim to specific spheres of action. The war years, in particular, offered these “female comrades” chances for promotion and to expand their fields of activity. The contributions in this volume build on the rather minimal existing knowledge about the interpretive patterns and manners of conduct of a large number of non-persecuted so-called Aryan women during National Socialism.

  7. 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.

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

    Science.gov (United States)

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

    2015-01-01

    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. As expected, we found that a reward led to a repetition of the previous choice, whereas a penalty led to an avoidance of the previous choice. However, the effects of the reward magnitude and the penalty magnitude revealed a striking asymmetry. The choice repetition effect of a reward strongly 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 the 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 diffcult 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. PMID:25824862

  9. First clinical experiences with a new ovine Fab Echis ocellatus snake bite antivenom in Nigeria: randomized comparative trial with Institute Pasteur Serum (Ipser) Africa antivenom.

    Science.gov (United States)

    Meyer, W P; Habib, A G; Onayade, A A; Yakubu, A; Smith, D C; Nasidi, A; Daudu, I J; Warrell, D A; Theakston, R D

    1997-03-01

    During the past decade, effective snake antivenoms have become scarce in northern Nigeria. As a result, many patients severely envenomed by the saw-scaled or carpet viper (Echis ocellatus), which is responsible for more than 95% of the snake bites in the region, did not receive effective treatment and mortality and morbidity increased. To combat this crisis, a new monospecific ovine Fab antivenom (EchiTab) is being developed. Its theoretical advantages over conventional equine F(ab')2 antivenom are a more rapid tissue penetration and larger apparent volume of distribution (the volume of [tissue] fluid in which the the antivenom would be uniformly distributed to achieve the observed plasma concentration). In a preliminary study, two vials (20 ml; 1.0 g of protein) of EchiTab rapidly and permanently restored blood coagulability and cleared venom antigenemia in seven envenomed patients. Four experienced early reactions that responded to epinephrine. In a randomized comparative trial of one vial (10 ml; 0.5 g protein) of EchiTab or four ampules (40 ml; 2.12 g of protein) of Institute Pasteur Serum (Ipser) Africa polyspecific F(ab')2 antivenom, there were fewer reactions, but only 36% and 35% of patients, respectively, showed permanent restoration of coagulability, with the remainder requiring further doses. This suggests that 0.5 g (one vial) of EchiTab is approximately equivalent to 2.12 g (four ampules) of Ipser Africa antivenom, and that a higher initial dose will be required for most patients. Measurements of circulating venom and antivenom levels reflected the clinical events. PMID:9129531

  10. 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% (pspp., but none of the interventions significantly reduced the prevalence of Strongyloides stercoralis. Our findings support the notion that in high-endemicity areas, sustainable control of soil-transmitted helminth infections necessitates measures to reduce faecal environmental contamination to complement mass drug administration. However, elimination of soil-transmitted helminthiasis will not be achieved in the short run even with a package of interventions, and probably requires improvements in living conditions, changes in hygiene behaviour and more efficacious anthelminthic drugs and treatment

  11. P-wave velocity structure of the southern Ryukyu margin east of Taiwan: Results from the ACTS wide-angle seismic experiment

    Science.gov (United States)

    Klingelhoefer, F.; Berthet, T.; Lallemand, S.; Schnurle, P.; Lee, C.-S.; Liu, C.-S.; McIntosh, K.; Theunissen, T.

    2012-11-01

    An active seismic experiment has been conducted across the southern Ryukyu margin east of Taiwan over the whole trench-arc-backarc system in May 2009. Twenty-four ocean bottom seismometers (OBS) were deployed from the Ryukyu trench to the southern Okinawa trough over the Ryukyu arc and forearc. Wide angle seismic data were recorded by the OBS array while coincident reflection seismic data were acquired using a 6 km long streamer and a 6600 cubic inch seismic airgun array. Results from tomographic inversion of 21091 travel time picks along this line allowed us to image crustal structures of the Ryukyu margin down to a depth of 25 km. The transect has been designed to provide a better seismic velocity structure of the subduction zone in a highly deformed area that has produced an M8 earthquake in 1920. The line crosses a seismic cluster of earthquakes which source mechanisms are still poorly understood. The subducting oceanic crust of the Huatung Basin is about 5-6 km thick. The underlying mantle exhibits low seismic velocities around 7.8 km/s suggesting some hydrothermal alterations or alteration of the upper mantle through faults generated by the flexure of the subducting plate as it enters the subduction. Low velocities, up to 4.5 km/s, associated with the accretionary wedge are well imaged from the trench back to the Nanao forearc. A major result concerns the abrupt termination of the buttress at the rear of the accretionary wedge. Despite the low resolution of the tomographic inversion near the subduction interface, several lines of evidence supporting the presence of a low velocity zone beneath the toe of the forearc buttress could be established. The Moho beneath the Ryukyu non-volcanic arc is located at a depth around 25 km depth.

  12. 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.

  13. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks and Benefits Terms ... with Your Doctor Taking Medicines The information in this topic was provided by the National Library of ...

  14. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study that involves human subjects. The purpose of ...

  15. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... that could identify a disease in its early stages. Usually, trial participants must show signs of the ... Trials Clinical trials of drugs are usually described based on their phase. The U.S. Food and Drug ...

  16. 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 ...

  17. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study that involves human subjects. The purpose ...

  18. Patient and primary care provider experience using a family health history collection, risk stratification, and clinical decision support tool: a type 2 hybrid controlled implementation-effectiveness trial

    OpenAIRE

    Wu, R. Ryanne; Orlando, Lori A.; Himmel, Tiffany L; Buchanan, Adam H; Powell, Karen P; Hauser, Elizabeth R.; Agbaje, Astrid B; Henrich, Vincent C.; Ginsburg, Geoffrey S.

    2013-01-01

    Background Family health history (FHH) is the single strongest predictor of disease risk and yet is significantly underutilized in primary care. We developed a patient facing FHH collection tool, MeTree©, that uses risk stratification to generate clinical decision support for breast cancer, colorectal cancer, ovarian cancer, hereditary cancer syndromes, and thrombosis. Here we present data on the experience of patients and providers after integration of MeTree© into 2 primary care practices. ...

  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. Clinical experience with the MammoSite[reg] radiation therapy system for brachytherapy of breast cancer: Results from an international phase II trial

    International Nuclear Information System (INIS)

    Background and purpose: In a prospective multi-center phase II trial, we investigated the MammoSite[reg] Radiation Therapy System, a new device for delivering intracavitary brachytherapy following breast conserving surgery. The MammoSite[reg] is a dual lumen, closed ended catheter with a small, spherical inflatable balloon and a port for connecting a remote afterloader to the central lumen. We analyzed the surgical procedure and placement of the MammoSite[reg], treatment planning and radiation delivery complications and cosmesis, as well the comfort for the patients. Patients and methods: Between 2002 and 2004 a total of 32 patients (pts) were implanted using the MammoSite[reg]. The reference isodose was defined 1 cm from the balloon surface. We analyzed the post-implant anatomic position of the applicator and the geometric form of the balloon via ultrasound, CT and X-ray, related side effects, cosmetic outcome and patient quality of life. Results: Twenty-three out of 32 patients (72%) were eligible for MammoSite[reg] intracavitary brachytherapy. Twenty-eight percentage had to be excluded because of different reasons. Eleven patients were treated with primary brachytherapy with a total dose of 34 Gy (2x3.4 Gy) and 12 had a boost with a mean dose of 13.3 Gy (range: 7.5-15 Gy; 2x2.5 Gy) combined with EBRT and doses ranged between 46 and 50 Gy. In three cases a balloon rupture occurred. We observed two abscesses within 3 months of implantation and serious seroma development in 10 patients (39%). Skin related side effects were erythema in 21 patients (91%), hyperpigmentation in 13 patients (56%) and teleangiectasia in six patients (26%) after mean follow-up 20 months. Conclusions: The MammoSite[reg] Radiation Therapy System is a feasible treatment modality for intracavitary brachytherapy of breast cancer after breast conserving surgery. The advantage of the system is only one applicator is necessary for the delivery of a fractionated radiotherapy. In addition, patient

  1. 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

  2. Challenges of maintaining research protocol fidelity in a clinical care setting: A qualitative study of the experiences and views of patients and staff participating in a randomized controlled trial

    OpenAIRE

    Farmer Andrew J; Holman Rury R; Darbyshire Julie L; Jenkins Nicholas; Lawton Julia; Hallowell Nina

    2011-01-01

    Abstract Background Trial research has predominantly focused on patient and staff understandings of trial concepts and/or motivations for taking part, rather than why treatment recommendations may or may not be followed during trial delivery. This study sought to understand why there was limited attainment of the glycaemic target (HbA1c ≤6.5%) among patients who participated in the Treating to Target in Type 2 Diabetes Trial (4-T). The objective was to inform interpretation of trial outcomes ...

  3. 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.

  4. Microbicide clinical trial adherence: insights for introduction.

    Science.gov (United States)

    Woodsong, Cynthia; MacQueen, Kathleen; Amico, K Rivet; Friedland, Barbara; Gafos, Mitzy; Mansoor, Leila; Tolley, Elizabether; McCormack, Sheena

    2013-01-01

    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. PMID:23561044

  5. 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.

  6. Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials.

    Science.gov (United States)

    Theoret, Marc R; Pai-Scherf, Lee H; Chuk, Meredith K; Prowell, Tatiana M; Balasubramaniam, Sanjeeve; Kim, Tamy; Kim, Geoffrey; Kluetz, Paul G; Keegan, Patricia; Pazdur, Richard

    2015-10-15

    In 1962, the passage of the Kefauver-Harris Amendment to the 1938 Food, Drug, and Cosmetic Act required that sponsors seeking approval of new drugs demonstrate the drug's efficacy, in addition to its safety, through a formal process that includes "adequate and well-controlled" clinical trials as the basis to support claims of effectiveness. As a result of this amendment, FDA formalized in regulation the definitions of various phases of clinical investigations (i.e., phase I, phase II, and phase III). The clinical drug development paradigm for anticancer drugs intended to support marketing approval has historically followed this "phased" approach with sequential, stand-alone trials, with an increasing number of patients exposed to an investigational drug with each trial in order to fulfill the objectives of that particular stage in development. Increasingly, it is the Office of Hematology and Oncology Products' experience that commercial sponsors of solid tumor oncology drug development programs are amending ongoing phase I trials to add expansion cohorts designed to evaluate study objectives typical of later-phase trials. For investigational anticancer drugs that demonstrate preliminary clinical evidence of substantial antitumor activity early in clinical testing, use of expansion cohorts as a component of the solid tumor oncology drug development pathway, with appropriate measures to mitigate the risks of this approach, may fit in well with the goals and concepts described by FDA's expedited programs for serious conditions. PMID:26473190

  7. Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials.

    Science.gov (United States)

    Theoret, Marc R; Pai-Scherf, Lee H; Chuk, Meredith K; Prowell, Tatiana M; Balasubramaniam, Sanjeeve; Kim, Tamy; Kim, Geoffrey; Kluetz, Paul G; Keegan, Patricia; Pazdur, Richard

    2015-10-15

    In 1962, the passage of the Kefauver-Harris Amendment to the 1938 Food, Drug, and Cosmetic Act required that sponsors seeking approval of new drugs demonstrate the drug's efficacy, in addition to its safety, through a formal process that includes "adequate and well-controlled" clinical trials as the basis to support claims of effectiveness. As a result of this amendment, FDA formalized in regulation the definitions of various phases of clinical investigations (i.e., phase I, phase II, and phase III). The clinical drug development paradigm for anticancer drugs intended to support marketing approval has historically followed this "phased" approach with sequential, stand-alone trials, with an increasing number of patients exposed to an investigational drug with each trial in order to fulfill the objectives of that particular stage in development. Increasingly, it is the Office of Hematology and Oncology Products' experience that commercial sponsors of solid tumor oncology drug development programs are amending ongoing phase I trials to add expansion cohorts designed to evaluate study objectives typical of later-phase trials. For investigational anticancer drugs that demonstrate preliminary clinical evidence of substantial antitumor activity early in clinical testing, use of expansion cohorts as a component of the solid tumor oncology drug development pathway, with appropriate measures to mitigate the risks of this approach, may fit in well with the goals and concepts described by FDA's expedited programs for serious conditions.

  8. 20 CFR 404.1592 - The trial work period.

    Science.gov (United States)

    2010-04-01

    ....1592 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY... of disability benefit under title II of the Social Security Act (i.e., child's benefits based on... the trial work period in determining whether your disability ended at any time after the trial...

  9. 20 CFR 220.170 - The trial work period.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 1 2010-04-01 2010-04-01 false The trial work period. 220.170 Section 220.170 Employees' Benefits RAILROAD RETIREMENT BOARD REGULATIONS UNDER THE RAILROAD RETIREMENT ACT DETERMINING DISABILITY Trial Work Period and Reentitlement Period for Annuitants Disabled for Any...

  10. Clinical trials of homoeopathy.

    OpenAIRE

    Kleijnen, J.; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURE...

  11. 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.

  12. Nuclear Regulatory Authority Act, 2015 (Act 895)

    International Nuclear Information System (INIS)

    An Act to establish a Nuclear Regulatory Authority in Ghana. This Act provides for the regulation and management of activities and practices for the peaceful use of nuclear material or energy, and to provide for the protection of persons and the environment against the harmful effects of radiation; and to ensure the effective implementation of the country’s international obligations and for related matters. This Act replaced the Radiation Protection Instrument, of 1993 (LI 1559).

  13. 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

  14. From randomised trials to rational practice.

    Science.gov (United States)

    van Gijn, J

    2005-01-01

    From the age of Enlightenment onwards, philosophical thinking has become increasingly influenced by empiricism: observations lead to theories, but experiments are needed to put the reasoning to the test. However, it was not until the middle of the 20th century that well-designed experiments were at last introduced in medical treatment, in the form of randomised controlled clinical trials. This design is now standard in medicine, but in everyday practice a multitude of management decisions must still be taken without good evidence. There are several reasons for this: there may not be a trial at all or only a single trial; trial results may be equivocal; patients may be different from those enrolled in trials; new procedures require practice, or a trial may not be feasible. 'Logical reasoning', with all its fallacies, is still required - not only to fill the gaps in empirical knowledge but also to interpret existing evidence and to plan new trials. In fact, the generation of new knowledge is a continuous, cyclical process in which newly gained insights in pathophysiology give rise to new therapeutic experiments, the results of which generate fresh hypotheses, and so on. Compassion, curiosity and doubt are the essential forces that keep the cycle moving. Conversely, the progress is slowed down by present-day legalism, which distorts investigator accountability and patient autonomy.

  15. 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

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical ... researchers may gather information about experimental treatments, their risks, and how well they work compare existing therapies ...

  17. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... the body laboratory tests that check samples of blood, urine, or other body tissues genetic tests that look for genes linked to some types of disease. Diagnostic Trials In diagnostic trials, researchers ...

  18. 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.

  19. 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

  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. 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. PMID:25013247

  2. 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.

  3. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... was provided by the National Library of Medicine Topic last reviewed: December 2013 For an enhanced version of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is ...

  4. Organising trials by themes

    NARCIS (Netherlands)

    Hop, M.E.C.M.

    2013-01-01

    In recent years in the Netherlands the demand for a different type of cultivar trial has increased: the themed trial. Themed trials gather information on one property of a range of garden plants, like their winter hardiness or scent, or research the suitability of a range of plants for a specific us

  5. 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...

  6. Assertive Community Treatment (ACT)

    Science.gov (United States)

    ... services—including both ER visits and inpatient hospitalizations—ACT team members are also well-connected with local hospitals and have the ability to work with hospital and emergency room staff. ACT teams ...

  7. ACTS data center

    Science.gov (United States)

    Syed, Ali; Vogel, Wolfhard J.

    1993-01-01

    Viewgraphs on ACTS Data Center status report are included. Topics covered include: ACTS Data Center Functions; data flow overview; PPD flow; RAW data flow; data compression; PPD distribution; RAW Data Archival; PPD Audit; and data analysis.

  8. A novel elevated plus-maze procedure to avoid the one-trial tolerance problem

    Directory of Open Access Journals (Sweden)

    Peggy eSchneider

    2011-07-01

    Full Text Available The elevated plus-maze (EPM test is one of the most commonly used behavioural assays to evaluate anxiety-related behaviour in rodents. It is a rather economic test which usually uses a short (5 min protocol and does not require conditioning of the animals. The critical measure for anxiety is the time spent in the open arms of the maze. A confounding problem of the EPM is the so called one-trial tolerance (OTT, characterised by a marked decrease of open arm exploration in spite of treatment with anxiolytic acting benzodiazepines upon re-exposure to the EPM. This consistent finding is often raised as an evidence for the inappropriateness to re-test rodents in the EPM. However, a reliable re-test paradigm would broaden the usability and effectiveness of this test.Therefore, we tested how a prolongation of the inter-trial interval to 28 days (instead of the usual 24 hours, and an additional change of the testing room would affect the open arm time and other behaviours on the EPM. In two experiments, drug naive Wistar rats were exposed to the EPM on trial 1, and treated intraperitoneally with either vehicle or midazolam (0.25 mg/kg 30 min before trial 2. Then, trial 2 (28 days after trial 1 was carried out in either the same testing room (Exp. 1 or a second unfamiliar room (Exp. 2.Twenty-eight days after trial 1 the open arm time of the rats in the vehicle treated control rats of both experimental groups was comparable to that of the first trial, independent of the testing room. Most importantly, we found that the treatment with the benzodiazepine midazolam had a significantly anxiolytic-like (i.e. increase of open arm time effect in trial 2 only when conducted in the previously unfamiliar testing room (Exp. 2. We suggest that in order to reliably re-test the EPM and to prevent confounding effects due to the OTT, an inter-trial interval of 28 days and a change in testing rooms reinstates anxiolytic-like actions of benzodiazepines

  9. Nuclear Installations Act 1965

    International Nuclear Information System (INIS)

    This Act governs all activities related to nuclear installations in the United Kingdom. It provides for the licensing procedure for nuclear installations, the duties of licensees, the competent authorities and carriers of nuclear material in respect of nuclear occurrences, as well as for the system of third party liability and compensation for nuclear damage. The Act repeals the Nuclear Installations (Licensing and Insurance) Act 1959 and the Nuclear Installations (Amendment Act) 1965 except for its Section 17(2). (NEA)

  10. 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.

  11. Forgetting ACT UP

    Science.gov (United States)

    Juhasz, Alexandra

    2012-01-01

    When ACT UP is remembered as the pinnacle of postmodern activism, other forms and forums of activism that were taking place during that time--practices that were linked, related, just modern, in dialogue or even opposition to ACT UP's "confrontational activism"--are forgotten. In its time, ACT UP was embedded in New York City, and a larger world,…

  12. 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

    Science.gov (United States)

    2012-01-01

    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. PMID:22727048

  13. 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.

  14. 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.

  15. 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

  16. Market Trials of Irradiated Spices

    International Nuclear Information System (INIS)

    Full text: The objectives of the experiment were to disseminate irradiated retail foods to the domestic publics and to test consumer acceptance on irradiated ground chilli and ground pepper. Market trials of irradiated ground chilli and ground pepper were carried out at 2 local markets and 4 in Bangkok and Nontaburi in 2005-2007. Before the start of the experiment, processing room, gamma irradiation room and labels of the products were approved by Food and Drug Administration, Thailand. 50 grams of irradiated products were packaged in plastic bags for the market trials. 688 and 738 bags of ground chilli and ground pepper were sold, respectively. Questionnaires distributed with the products were commented by 59 consumers and statistically analyzed by experimental data pass program. 88.1 and 91.4 percents of the consumers were satisfied with the quality and the price, respectively. 79.7% of the consumers chose to buy irradiated ground chilli and ground pepper because they believed that the quality of irradiated products were better than that of non-irradiated ones. 91.5% of the consumers would certainly buy irradiated chilli and pepper again. Through these market trials, it was found that all of the products were sold out and the majority of the consumers who returned the questionnaires was satisfied with the irradiated ground chilli and ground pepper and also had good attitude toward irradiated foods

  17. On the scientific inference from clinical trials.

    Science.gov (United States)

    Holmberg, L; Baum, M; Adami, H O

    1999-05-01

    We have not been able to describe clearly how we generalize findings from a study to our own 'everyday patients'. This difficulty is not surprising, since generalization deals with how empirical observations are related to the growth of scientific knowledge, which is a major philosophical problem. An argument, sometimes used to discard evidence from a trial, is that the patient sample was too selected and therefore not 'representative' enough for the results to be meaningful for generalization. In this paper, we discuss issues of representativeness and generalizability. Other authors have shown that generalization cannot only depend on statistical inference. Then, how do randomized clinical trials contribute to the growth of knowledge? We discuss three aspects of the randomized clinical trial (Mant 1999), First, the trial is an empirical experiment set up to study the intervention on the question as specifically and as much in isolation from other -- biasing and confounding -- factors as possible (Rothman & Greenland 1998). Second, the trial is set up to challenge our prevailing hypotheses (or prejudices) and the trial is above all a help in error elimination (Popper 1992). Third, we need to learn to see new, unexpected and thought-provoking patterns in the data from a trial. Point one -- and partly point two -- refers to the paradigm of the controlled experiment in scientific method. How much a study contributes to our knowledge, with respect to points two and three, relates to its originality. In none of these respects is the representativeness of the patients, or the clinical situations, crucial for judging the study and its possible inferences. However, we also discuss that the biological domain of disease that was studied in a particular trial has to be taken into account. Thus, the inference drawn from a clinical study is not only a question of statistical generalization, but must include a jump from the world of experiences into the world of reason

  18. 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. PMID:25904313

  19. 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...

  20. 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

  1. Radiological Protection Act 1970

    International Nuclear Information System (INIS)

    This Act provides for the establishment of a Radiological Protection Board to undertake research and advise on protection from radiation hazards. Its functions include provision of advice to Government departments with responsibilities in relation to protection of sectors of the community or the community as a whole against the hazards of ionizing radiation. The Act, which lays down that the Board shall replace certain departments concerned with radiation protection, repeals several Sections of the Radioactive Substances Act 1948 and the Science and Technology Act 1965. (NEA)

  2. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials ... 000 people. If the U.S. Food and Drug Administration agrees that the trial results are positive, they ...

  3. 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 ...

  4. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... IV trial for drugs or devices takes place after the U.S. Food and Drug Administration approves their ...

  5. Current Clinical Trials Testing Combinations of Immunotherapy and Radiation

    OpenAIRE

    Crittenden, M.; Kohrt, H.; Levy, R.; Jones, J.; Camphausen, K.; Dicker, A.; Demaria, S.; Formenti, S.

    2015-01-01

    Preclinical evidence of successful combinations of ionizing radiation with immunotherapy has inspired testing the translation of these results to the clinic. Interestingly, the preclinical work has consistently predicted the responses encountered in clinical trials. The first example came from a proof-of-principle trial started in 2001 that tested the concept that growth factors acting on antigen-presenting cells improve presentation of tumor antigens released by radiation and induce an absco...

  6. “Until the trial is complete you can’t really say whether it helped you or not, can you?”: exploring cancer patients’ perceptions of taking part in a trial of acupressure wristbands

    OpenAIRE

    Hughes, John Gareth; Russell, Wanda; Breckons, Matthew; Richardson, Janet; Lloyd-Williams, Mari; Molassiotis, Alex

    2013-01-01

    Background Nested qualitative studies within clinical trials provide data on patients’ experiences of receiving trial interventions and can inform and improve trial designs. The present study explored patients’ experiences of participating in a randomised controlled trial of acupressure wristbands for chemotherapy related nausea. Methods A randomised three-group sham-controlled trial was carried out to evaluate the effectiveness of acupressure wristbands in the management of chemotherapy-rela...

  7. Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available.

    Science.gov (United States)

    Hernán, Miguel A; Robins, James M

    2016-04-15

    Ideally, questions about comparative effectiveness or safety would be answered using an appropriately designed and conducted randomized experiment. When we cannot conduct a randomized experiment, we analyze observational data. Causal inference from large observational databases (big data) can be viewed as an attempt to emulate a randomized experiment-the target experiment or target trial-that would answer the question of interest. When the goal is to guide decisions among several strategies, causal analyses of observational data need to be evaluated with respect to how well they emulate a particular target trial. We outline a framework for comparative effectiveness research using big data that makes the target trial explicit. This framework channels counterfactual theory for comparing the effects of sustained treatment strategies, organizes analytic approaches, provides a structured process for the criticism of observational studies, and helps avoid common methodologic pitfalls. PMID:26994063

  8. 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...... 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...... and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety...

  9. 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...

  10. 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. PMID:26593118

  11. Canada's Clean Air Act

    International Nuclear Information System (INIS)

    This paper provided an outline of Canada's Clean Air Act and examined some of the regulatory changes that will occur as a result of its implementation. The Act is being introduced to strengthen the legislative basis for taking action on reducing air pollution and GHGs, and will allow the government to regulate both indoor and outdoor air pollutants and GHGs. The Act will require the Ministers of the Environment and Health to establish national air quality objectives, as well as to monitor and report on their attainment. The Canadian Environmental Protection Act will be amended to enable the government to regulate the blending of fuels and their components. The Motor Vehicle Fuel Consumption Standards Act will also be amended to enhance the government's authority to regulate vehicle fuel efficiency. The Energy Efficiency Act will also be expanded to allow the government to set energy efficiency standards and labelling requirements for a wider range of consumer and commercial products. The Act will commit to short, medium and long-term industrial air pollution targets. Regulations will be proposed for emissions from industry; on-road and off-road vehicles and engines; and consumer and commercial products. It was concluded that the Government of Canada will continue to consult with provinces, territories, industries and Canadians to set and reach targets for the reduction of both indoor and outdoor air pollutants and GHG emissions. 6 figs

  12. 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.

  13. The Energy Act 1983

    International Nuclear Information System (INIS)

    Part II of This Act came into force on 1 September 1983 and is concerned with nuclear installations. Its main purpose is to amend the Nuclear Installations Act 1965 to give effect to the provisions of two Protocols amending the Paris Convention on nuclear third party liability and the Brussels Convention Supplementary to the Paris Convention respectively. The principal effect of these modifications is to increase the sums available to meet claims for nuclear damage. The United Kingdom is a Party to both Conventions and the provisions of the 1983 Act will enable it to ratify the Protocols. (NEA)

  14. 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....

  15. 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 designed to…

  16. 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...

  17. 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)...

  18. 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...

  19. 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...

  20. 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)...

  1. 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...

  2. 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...

  3. Reducing lost to follow-up in a large clinical trial of prevention of mother-to-child transmission of HIV: The Breastfeeding, Antiretrovirals and Nutrition (BAN) study experience

    Science.gov (United States)

    Sellers, Christopher J; Lee, Hana; Chasela, Charles; Kayira, Dumbani; Soko, Alice; Mofolo, Innocent; Ellington, Sascha; Hudgens, Michael G; Kourtis, Athena P; King, Caroline C; Jamieson, Denise J; van der Horst, Charles

    2014-01-01

    Background/Aims Retaining patients in prevention of mother-to-child transmission of HIV studies can be challenging in resource limited settings, where high lost to follow-up (LTFU) rates have been reported. In this paper, we describe the effectiveness of methods used to encourage retention in the Breastfeeding, Antiretrovirals, and Nutrition (BAN) study and analyze factors associated with LTFU in the study. Methods The BAN clinical trial was designed to evaluate the efficacy of 3 different mother-to-child HIV transmission prevention strategies. Lower than expected participant retention prompted enhanced efforts to reduce LTFU during the conduct of the trial. Following study completion, we employed regression modeling to determine predictors of perfect attendance and variables associated with being LTFU. Results During the study, intensive tracing efforts were initiated after the first 1686 mother-infant pairs had been enrolled, and 327 pairs were missing. Sixty of these pairs were located and had complete data obtained. Among the 683 participants enrolling after initiation of intensive tracing efforts, the LTFU rate was 3.4%. At study's end, 290 (12.2%) of the 2369 mother-infant pairs were LTFU. Among successfully traced missing pairs, relocation was common and three were deceased. Log-binomial regression modeling revealed higher maternal hemoglobin and older maternal age to be significant predictors of perfect attendance. These factors and the presence of food insecurity were also significantly associated with lower rates of LTFU. Conclusions In this large HIV prevention trial, intensive tracing efforts centered on reaching study participants at their homes succeeded in finding a substantial proportion of LTFU participants, and were very effective in preventing further LTFU during the remainder of the trial. The association between food insecurity and lower rates of LTFU is likely related to the study's provision of nutritional support, including a family maize

  4. 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 ...

  5. 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, ...

  6. 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

  7. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials Videos quiz yourself MedlinePlus for More Information National Institute on Aging Related Topics Talking with Your Doctor Taking Medicines The information in this topic was provided by the National ...

  8. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Drug Administration typically requires Phase 1, 2 and 3 trials to be conducted to determine if the ... subjects usually ranges from several hundred to about 3,000 people. If the U.S. Food and Drug ...

  9. 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...

  10. 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...

  11. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Learn More Participating in Clinical Trials Videos quiz yourself MedlinePlus for More Information National Institute on Aging Related Topics Talking with Your Doctor Taking Medicines The information in ...

  12. 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.

  13. Pseudo force acting between bodies

    Science.gov (United States)

    Baruah, Abhinav Ray; Deva, Anish; Sarma, Arun

    It has been shown that a non-contact force acts between two macroscopic physical objects held close together, which is not associated with the gravitational and electrostatic force. An experiment was conducted with objects of different mass, material and geometry to find the magnitude and properties of this apparent or pseudo force. The order of magnitude was found to be 10-5 and it remained constant for all types of objects while only the coefficient increased as the distance between the objects reduced. It only started acting at small distances and failed to make a body move if it experienced static friction from any contact surface. The nature of the force was found to be attractive as well as repulsive. Due to gravitation being a solely attractive force, it was eliminated as a possible reason for the pseudo force. The experiment was performed twice, once by grounding the apparatus and then again without grounding. The order of the force remained the same for both cases. As the test objects were held by hand, they were grounded through the human body. Also, none of the objects used were in contact with each other for the duration of this work, preventing any contact electrification. Due to these factors, the force was not considered electrostatic in nature.

  14. Overcoming Recruitment Challenges in Palliative Care Clinical Trials

    OpenAIRE

    LeBlanc, Thomas W.; Lodato, Jordan E.; Currow, David C; Abernethy, Amy P.

    2013-01-01

    Challenges to clinical trial recruitment in palliative care are significant but not insurmountable. Through their experience with designing and deploying a social-marketing based protocol, the authors show that a carefully crafted recruitment and retention protocol can be effective.

  15. Cognitive rehabilitation in patients with gliomas : a randomized, controlled trial

    NARCIS (Netherlands)

    Gehring, Karin; Sitskoorn, Margriet M; Gundy, Chad M; Sikkes, Sietske A M; Klein, Martin; Postma, Tjeerd J; van den Bent, Martin J; Beute, Guus N; Enting, Roelien H.; Kappelle, Arnoud C; Boogerd, Willem; Veninga, Theo; Twijnstra, Albert; Boerman, Dolf H; Taphoorn, Martin J B; Aaronson, Neil K

    2009-01-01

    PURPOSE: Patients with gliomas often experience cognitive deficits, including problems with attention and memory. This randomized, controlled trial evaluated the effects of a multifaceted cognitive rehabilitation program (CRP) on cognitive functioning and selected quality-of-life domains in patients

  16. Use of heparins in patients with cancer: individual participant data meta-analysis of randomised trials study protocol

    Science.gov (United States)

    Schünemann, Holger J; Ventresca, Matthew; Crowther, Mark; Briel, Matthias; Zhou, Qi; Garcia, David; Lyman, Gary; Noble, Simon; Macbeth, Fergus; Griffiths, Gareth; DiNisio, Marcello; Beyene, Joseph; Mbuagbaw, Lawrance; Neumann, Ignacio; Van Es, Nick; Brouwers, Melissa; Brozek, Jan; Guyatt, Gordon; Levine, Mark; Moll, Stephan; Santesso, Nancy; Streiff, Michael; Baldeh, Tejan; Florez, Ivan; Gurunlu Alma, Ozlem; Solh, Ziad; Ageno, Walter; Marcucci, Maura; Bozas, George; Zulian, Gilbert; Maraveyas, Anthony; Lebeau, Bernard; Buller, Harry; Evans, Jessica; McBane, Robert; Bleker, Suzanne; Pelzer, Uwe; Akl, Elie A

    2016-01-01

    Introduction Parenteral anticoagulants may improve outcomes in patients with cancer by reducing risk of venous thromboembolic disease and through a direct antitumour effect. Study-level systematic reviews indicate a reduction in venous thromboembolism and provide moderate confidence that a small survival benefit exists. It remains unclear if any patient subgroups experience potential benefits. Methods and analysis First, we will perform a comprehensive systematic search of MEDLINE, EMBASE and The Cochrane Library, hand search scientific conference abstracts and check clinical trials registries for randomised control trials of participants with solid cancers who are administered parenteral anticoagulants. We anticipate identifying at least 15 trials, exceeding 9000 participants. Second, we will perform an individual participant data meta-analysis to explore the magnitude of survival benefit and address whether subgroups of patients are more likely to benefit from parenteral anticoagulants. All analyses will follow the intention-to-treat principle. For our primary outcome, mortality, we will use multivariable hierarchical models with patient-level variables as fixed effects and a categorical trial variable as a random effect. We will adjust analysis for important prognostic characteristics. To investigate whether intervention effects vary by predefined subgroups of patients, we will test interaction terms in the statistical model. Furthermore, we will develop a risk-prediction model for venous thromboembolism, with a focus on control patients of randomised trials. Ethics and dissemination Aside from maintaining participant anonymity, there are no major ethical concerns. This will be the first individual participant data meta-analysis addressing heparin use among patients with cancer and will directly influence recommendations in clinical practice guidelines. Major cancer guideline development organisations will use eventual results to inform their guideline

  17. [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.

  18. Time Trials--An AP Physics Challenge Lab

    Science.gov (United States)

    Jones, David

    2009-01-01

    I have come to the conclusion that for high school physics classroom and laboratory experiences, simpler is better! In this paper I describe a very simple and effective lab experience that my AP students have thoroughly enjoyed year after year. I call this lab exercise "Time Trials." The experiment is simple in design and it is a lot of fun for…

  19. Atomic Energy Act 1989

    International Nuclear Information System (INIS)

    This Act, which entered into force on 1 september 1989, contains a series of provisions dealing with different subjects: increase of public financing for British Nuclear Fuels plc, amendment of the Nuclear Installations Act 1965 regarding the powers of the Health and Safety Executive to recover expenses directly from nuclear operators and obligation of the UKAEA to take out insurance or other financial security to cover its liability and finally, measures to enable the UK to ratify the IAEA Convention on Assistance in Case of a Nuclear Accident or Radiological Emergency

  20. 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.

  1. 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.

  2. 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...

  3. 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...

  4. 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...

  5. 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…

  6. 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 reporting of clinical trials for knee OA we initially drafted recommendations through an iterative process. Members of the working group included representatives from industry and academia. After the working group members reviewed a final draft, they scored the appropriateness for recommendations. After...... 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...

  7. 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.

  8. 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.

  9. On Retractable S-Acts

    Institute of Scientific and Technical Information of China (English)

    R.KHOSRAVI

    2012-01-01

    In this paper we introduce a class of right S-acts called retractable S-acts which are right S-acts with homomorphisms into their all subacts.We also give some classifications of monoids by comparing such acts with flatness properties.

  10. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... experimental treatment on a small group of often healthy people (20 to 80), to judge its safety ...

  11. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... to find out if an 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 ... universities and medical centers across the country. The National Institutes of ...

  12. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... to obtain preliminary data on whether the drug works in people who have a certain disease or ...

  13. The ONTARGET trial programme

    DEFF Research Database (Denmark)

    Unger, Thomas; Kintscher, Ulrich; Kappert, Kai;

    2009-01-01

    consisting of cardiovascular death, non-fatal stroke or myocardial infarction and hospitalisation for congestive heart failure. Patient selection and study procedures followed the previous HOPE trial. In the parallel TRANSCEND study, nearly 6.000 patients, all intolerant to ACE inhibition, were subjected...

  14. 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...

  15. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... are usually described based on their phase. The U.S. Food and Drug Administration typically requires Phase 1, ... hundred to about 3,000 people. If the U.S. Food and Drug Administration agrees that the trial ...

  16. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... Reports Clinician Tools Clinician Tools Home Guidelines and Best Practices Topic Reviews Algorithms, Screens, Toolkits Provider Education Provider ... about federally and privately supported clinical research in human volunteers. Site gives information about a trial's purpose, who may participate, locations, and phone ... Forms State and Local Resources Strat Plan FY 2014-2020 VA Plans, Budget, & ...

  17. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A B; Smith, G;

    2016-01-01

    of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. METHODS: This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using...

  18. 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...

  19. The Act of Walking

    DEFF Research Database (Denmark)

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

    2014-01-01

    ; Frumkin 2002). The term ‘walkability’ focuses on how the physical structures in the urban environment can promote walking, and how this potentially eases issues of public health and liveability in our cities (Krizek et al. 2009). However, the study of walking should not be reduced merely to the ‘hardware...... factors like lifestyle and life situation should be addressed in order to understand ‘walkability’ fully. The challenge is to approach issues linked to the ‘more-than representational’ (Thrift 2007; Vannini 2012) act of walking and thereby understand pedestrian behaviour in general, but also...... the individual perception of walking. This chapter exemplifies shows how a ‘more-than representational’ dimension can be added to the act of walking and open up for a more value-based discussion of walking, in this chapter exemplified in the Danish context. The chapter provides seven different cases of how...

  20. Reduction of transmission from malaria patients by artemisinin combination therapies: a pooled analysis of six randomized trials

    Directory of Open Access Journals (Sweden)

    Bousema Teun

    2008-07-01

    Full Text Available Abstract Background Artemisinin combination therapies (ACT, which are increasingly being introduced for treatment of Plasmodium falciparum malaria, are more effective against sexual stage parasites (gametocytes than previous first-line antimalarials and therefore have the potential to reduce parasite transmission. The size of this effect is estimated in symptomatic P. falciparum infections. Methods Data on 3,174 patients were pooled from six antimalarial trials conducted in The Gambia and Kenya. Multivariable regression was used to investigate the role of ACT versus non-artemisinin antimalarial treatment, treatment failure, presence of pre-treatment gametocytes and submicroscopic gametocytaemia on transmission to mosquitoes and the area under the curve (AUC of gametocyte density during the 28 days of follow up. Results ACT treatment was associated with a significant reduction in the probability of being gametocytaemic on the day of transmission experiments (OR 0.20 95% CI 0.16–0.26, transmission to mosquitoes by slide-positive gametocyte carriers (OR mosquito infection 0.49 95% CI 0.33–0.73 and AUC of gametocyte density (ratio of means 0.35 95% CI 0.31–0.41. Parasitological treatment failure did not account for the difference between ACT and non-artemisinin impact. The presence of slide-positive gametocytaemia prior to treatment significantly reduced ACT impact on gametocytaemia (p Conclusion Treatment with ACT significantly reduces infectiousness of individual patients with uncomplicated falciparum malaria compared to previous first line treatments. Rapid treatment of cases before gametocytaemia is well developed may enhance the impact of ACT on transmission.

  1. Radiological protection act, 1991

    International Nuclear Information System (INIS)

    This Act provides for the establishment of the Radiological Protection Institute of Ireland and dissolves An Bord Fuinnimh Nuicleigh (the Board), transferring its assets and liabilities to the Institute. It sets out a range of radiation protection measures to be taken by various Ministers in the event of a radiological emergency and gives effect at national level to the Assistance Convention, the Early Notification Convention and the Physical Protection Convention. The Institute is the competent Irish authority for the three Conventions. (NEA)

  2. 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).

  3. On Speech Act Theory

    Institute of Scientific and Technical Information of China (English)

    邓仁毅

    2009-01-01

    Speech act has developed from the work of linguistic philosophers and originates in Austin's observation and study. It was the particular search for the eonstative, utterances which describe something outside the text and can therefore be judged true or false that prompted John L. Austin to direct his attention to the distinction with so -called performa-tires. The two representative linguists are Aus-tin and Searle.

  4. Acting for Opera Singers

    OpenAIRE

    Hamilton, Jennifer

    2015-01-01

    As the majority of professional classical singers earn a significant part of their living in opera, it is vital that conservatoires and studios are able to provide fit-for-purpose education for these trainee artists. As opera productions today are increasingly influenced by the trends in cinema and live-streamed media, this study sought to identify and clarify the range and detail of acting and performance skills required of opera singers in this evolving professional environment. A significa...

  5. Clinical Trials Registration and Results Information Submission. Final rule.

    Science.gov (United States)

    2016-09-21

    This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research. The requirements apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drug products (including biological products) and device products that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device product that are ordered by FDA. PMID:27658315

  6. HIV/AIDS Clinical Trials

    Science.gov (United States)

    ... Home Apps APIs Widgets Order Publications Skip Nav HIV/AIDS Clinical Trials Home > Clinical Trials Español small ... Renal (Kidney) Complications/Damage Skin Diseases FDA-Approved HIV Drugs Abacavir Atazanavir Atripla Cobicistat Combivir Complera Darunavir ...

  7. Acting and Teacher Education: Being Model for Identity Development

    OpenAIRE

    Kemal Sinan Özmen

    2011-01-01

    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, Generat...

  8. The Trial of Katherine Harrison.

    Science.gov (United States)

    Woodward, Walter W.

    2003-01-01

    Presents a lesson plan in which the teacher and students participate in a mock trial of Katherine Harrison, who was accused of witchcraft in the seventeenth century. Provides background information about the trial, as well as primary sources of the testimonies given by witnesses during the trial. (CMK)

  9. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

    Østervig, R M; Sonne, A; Rasmussen, L S

    2015-01-01

    starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...

  10. 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...

  11. The COLOFOL trial

    DEFF Research Database (Denmark)

    Hansdotter Andersson, Pernilla; Wille-Jørgensen, Peer; Horváth-Puhó, Erzsébet;

    2016-01-01

    in tumor location and stage distribution, with 5.6% more patients in the randomized group having colon cancer and 6.7% more patients having stage II disease. CONCLUSION: Patients in the two study arms were not only demographically similar, but also similar to nonincluded eligible patients, apart from stage......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...... population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24...

  12. 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: 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 LGS was equally efficacious.

  13. a randomized, controlled trial

    OpenAIRE

    Reinecke, Franziska

    2010-01-01

    The polycystic ovarian syndrome (PCOS) is characterized by hyperandrogenism and associated with obesity and impaired glucose metabolism. Despite the high prevalence of PCOS and the considerable clinical impact, the precise interplay between metabolism and hyperandrogenemia is not entirely clear. To analyse the effects of intravenous lipid and heparin infusion on circulating androgen levels in healthy women, we performed a randomized controlled cross-over trial. 12 healthy young women durin...

  14. Randomised clinical trial

    DEFF Research Database (Denmark)

    Meineche-Schmidt, V.; Christensen, E.; Bytzer, P.

    2011-01-01

    Background: Response to proton pump inhibitor (PPI) treatment in dyspepsia is unpredictable. Aim: To identify symptoms associated with response to esomeprazole in order to target patients for empirical treatment. Methods: Eight hundred and five uninvestigated, primary care patients with upper GI ....... Conclusions In patients with uninvestigated dyspepsia, PPI responders can be reliably identified by a simple pocket chart using symptoms and patient characteristics (ClinicalTrials.gov NCT00318968). © 2010 Blackwell Publishing Ltd....

  15. NATO SOCMET trials

    Science.gov (United States)

    Jenden, C. M.

    1993-11-01

    During 1993, Canada, France, Germany and the United Kingdom will be participating in the Smoke and Obscurants Countermeasures Materials Evaluation Tests (SOCMET). The tests will be carried out under the auspices of the NATO Army Armaments Group, AC/225, Panel VI, Sub-Panel 7 whose interests include multispectral smoke screening systems. The tests will comprise two sets of trials; one under cold climate conditions in Quebec, Canada, during February/March 1993 and the other in temperate conditions in Bourges, France during September 1993. This paper provides an insight into the management and aims of SOCMET. The evaluations will be seeking to identify candidate materials which create effective obscurant screens in the visible, infrared and millimetric bands of the electromagnetic spectrum. These materials will be disseminated through a range area dispersal. A key element of the trials will be the evaluation of field test instrumentation which may eventually lead to the development of standardized evaluation techniques. Following the trials, a scientific workshop will be held to review the results. A final report will be presented to NATO which will form the basis of future collaborative developments on multispectral screening systems leading towards standard NATO documentation on smoke and obscurant systems.

  16. 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…

  17. 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…

  18. Review of clinical trials for mitochondrial disorders: 1997-2012.

    Science.gov (United States)

    Kerr, Douglas S

    2013-04-01

    Over the last 15 years, some 16 open and controlled clinical trials for potential treatments of mitochondrial diseases have been reported or are in progress, and are summarized and reviewed herein. These include trials of administering dichloroacetate (an activator of pyruvate dehydrogenase complex), arginine or citrulline (precursors of nitric oxide), coenzyme Q10 (CoQ10; part of the electron transport chain and an antioxidant), idebenone (a synthetic analogue of CoQ10), EPI-743 (a novel oral potent 2-electron redox cycling agent), creatine (a precursor of phosphocreatine), combined administration (of creatine, α-lipoate, and CoQ10), and exercise training (to increase muscle mitochondria). These trials have included patients with various mitochondrial disorders, a selected subcategory of mitochondrial disorders, or specific mitochondrial disorders (Leber hereditary optic neuropathy or mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes). The trial designs have varied from open-label/uncontrolled, open-label/controlled, or double-blind/placebo-controlled/crossover. Primary outcomes have ranged from single, clinically-relevant scores to multiple measures. Eight of these trials have been well-controlled, completed trials. Of these only 1 (treatment with creatine) showed a significant change in primary outcomes, but this was not reproduced in 2 subsequent trials with creatine with different patients. One trial (idebenone treatment of Leber hereditary optic neuropathy) did not show significant improvement in the primary outcome, but there was significant improvement in a subgroup of patients. Despite the paucity of benefits found so far, well-controlled clinical trials are essential building blocks in the continuing search for more effective treatment of mitochondrial disease, and current trials based on information gained from these prior experiences are in progress. Because of difficulties in recruiting sufficient mitochondrial disease patients

  19. Study rationale and design of the CIMT trial: the Copenhagen Insulin and Metformin Therapy trial

    DEFF Research Database (Denmark)

    Lundby Christensen, L; Almdal, T; Boesgaard, T;

    2009-01-01

    unknown whether a combination of metformin and insulin analogues is superior to insulin analogues alone. Nor is it known which insulin analogue regimen is the optimal. OBJECTIVE: The primary objective of this trial is to evaluate the effect of an 18-month treatment with metformin vs. placebo...... in combination with one of three insulin analogue regimens, the primary outcome measure being carotid intima-media thickness (CIMT) in T2DM patients. DESIGN: A randomized, stratified, multicentre trial having a 2 x 3 factorial design. The metformin part is double masked and placebo controlled. The insulin......-acting insulin analogue. RANDOMIZATION: Central randomization stratified for age (above 65 years), previous insulin treatment and treatment centre. INTERVENTIONS: Metformin 1 g x two times daily vs. placebo (approximately 475 patients vs. 475 patients) in combination with insulin detemir before bedtime...

  20. Affordable Care Act and Women

    Science.gov (United States)

    ... Privacy Policy FOIA Plain Writing Act No Fear Act Disclaimers Viewers & Players Assistant Secretary for Planning and Evaluation, Room 415F U.S. Department of Health and Human Services 200 Independence Avenue, SW Washington, D.C. ...

  1. 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...

  2. 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.

  3. 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...... for future inquiry. We make recommendations about subject selection; the choice, definition and assessment of outcome measures; optimal treatments in relation to aura and headache; and we provide samples of study report forms used to record occurrence of aura and headache in this population....

  4. Future vision for the quality assurance of oncology clinical trials

    Directory of Open Access Journals (Sweden)

    Thomas eFitzGerald, MD

    2013-03-01

    Full Text Available The National Cancer Institute clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence based process improvements for clinical oncology patient care. The cooperative groups are undergoing a transformation process as we further integrate molecular biology into personalized patient care and move to incorporate international partners in clinical trials. To support this vision, data acquisition and data management informatics tools must become both nimble and robust to support transformational research at an enterprise level. Information, including imaging, pathology, molecular biology, radiation oncology, surgery, systemic therapy and patient outcome data needs to be integrated into the clinical trial charter using adaptive clinical trial mechanisms for design of the trial. This information needs to be made available to investigators using digital processes for real time data analysis. Future clinical trials will need to be designed and completed in a timely manner facilitated by nimble informatics processes for data management. This paper discusses both past experience and future vision for clinical trials as we move to develop data management and quality assurance processes to meet the needs of the modern trial.

  5. Translating clinical trials from human to veterinary oncology and back

    OpenAIRE

    Fürdös, Irene; Fazekas, Judit; Singer, Josef; Jensen-Jarolim, Erika

    2015-01-01

    In human medicine clinical trials are legally required for drug development and approval. In contrast, clinical trials in small animal cancer patients are less common and legally perceived as animal experiments. Comparative oncology has been recognized as a method to speed up the development of medications by introducing animal patients with naturally developing tumours. In such cases, using animal patients would generate more robust data, as their spontaneous disease resembles the “real life...

  6. 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.

  7. 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.

  8. ACT/SAT College Survey.

    Science.gov (United States)

    Stafford, John E.

    1998-01-01

    Reports on findings of a survey designed to discover whether higher education institutions' admission standards accept SAT I or ACT and if there is preference for either, and whether ACT could be submitted in lieu of SAT II subject tests. Eighty-six percent of the reporting schools indicated no preference; 28 schools indicated that the ACT was an…

  9. Atomic Energy Authority Act 1954

    International Nuclear Information System (INIS)

    This Act provides for the setting up of an Atomic Energy Authority for the United Kingdom. It also makes provision for the Authority's composition, powers, duties, rights and liabilities, and may amend, as a consequence of the establishment of the Authority and in connection therewith, the Atomic Energy Act, 1946, the Radioactive Substances Act 1948 and other relevant enactments. (NEA)

  10. 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…

  11. 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.

  12. Trial-by-trial changes in a priori informational value of external cues and subjective expectancies in human auditory attention.

    Directory of Open Access Journals (Sweden)

    Antonio Arjona

    Full Text Available BACKGROUND: Preparatory activity based on a priori probabilities generated in previous trials and subjective expectancies would produce an attentional bias. However, preparation can be correct (valid or incorrect (invalid depending on the actual target stimulus. The alternation effect refers to the subjective expectancy that a target will not be repeated in the same position, causing RTs to increase if the target location is repeated. The present experiment, using the Posner's central cue paradigm, tries to demonstrate that not only the credibility of the cue, but also the expectancy about the next position of the target are changed in a trial by trial basis. Sequences of trials were analyzed. RESULTS: The results indicated an increase in RT benefits when sequences of two and three valid trials occurred. The analysis of errors indicated an increase in anticipatory behavior which grows as the number of valid trials is increased. On the other hand, there was also an RT benefit when a trial was preceded by trials in which the position of the target changed with respect to the current trial (alternation effect. Sequences of two alternations or two repetitions were faster than sequences of trials in which a pattern of repetition or alternation is broken. CONCLUSIONS: Taken together, these results suggest that in Posner's central cue paradigm, and with regard to the anticipatory activity, the credibility of the external cue and of the endogenously anticipated patterns of target location are constantly updated. The results suggest that Bayesian rules are operating in the generation of anticipatory activity as a function of the previous trial's outcome, but also on biases or prior beliefs like the "gambler fallacy".

  13. Effect of assertive outreach after suicide attempt in the AID (assertive intervention for deliberate self harm) trial

    DEFF Research Database (Denmark)

    Morthorst, Britt; Krogh, Jesper; Erlangsen, Annette;

    2012-01-01

    OBJECTIVE: To assess whether an assertive outreach intervention after suicide attempt could reduce the frequency of subsequent suicidal acts, compared with standard treatment. DESIGN: Randomised, parallel group, superiority trial with blinded outcome assessment. SETTING: Outpatient intervention a...

  14. A Balancing Act?

    DEFF Research Database (Denmark)

    Gerstlberger, Wolfgang; Stampe, Ian; Knudsen, Mette Præst

    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...... 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...

  15. Metacognition of Working Memory Performance: Trial-by-Trial Subjective Effects from a New Paradigm.

    Science.gov (United States)

    Garcia, Andrew C; Bhangal, Sabrina; Velasquez, Anthony G; Geisler, Mark W; Morsella, Ezequiel

    2016-01-01

    Investigators have begun to examine the fleeting urges and inclinations that subjects experience when performing tasks involving response interference and working memory. Building on this research, we developed a paradigm in which subjects, after learning to press certain buttons when presented with certain letters, are presented with two action-related letters (the memoranda) but must withhold responding (4 s) until cued to emit the response associated with only one of the two letters. In the Congruent condition, the action corresponds to the cue (e.g., memoranda = AB, cue = B, response = B); in the Incongruent condition, the action corresponds to the other item of the memoranda (e.g., memoranda = AB, cue = B, response = A). After each trial, subjects inputted a rating regarding their subjectively experienced "urge to err" on that trial. These introspection-based data revealed that, as found in previous research, urges to err were strongest for incongruent trials. Our findings reveal, first, that subjects can successfully perform this new task, even though it is more complex than that of previous studies, and second, that, in this new paradigm, reliable subjective, metacognitive data can be obtained on a trial-by-trial basis. We hope that our novel paradigm will serve as a foundation for future experimental projects on the relationship between working memory performance and consciousness-an under-explored nexus whose investigation is likely to reveal insights about working memory, cognitive control, and metacognition.

  16. Metacognition of Working Memory Performance: Trial-by-Trial Subjective Effects from a New Paradigm

    Science.gov (United States)

    Garcia, Andrew C.; Bhangal, Sabrina; Velasquez, Anthony G.; Geisler, Mark W.; Morsella, Ezequiel

    2016-01-01

    Investigators have begun to examine the fleeting urges and inclinations that subjects experience when performing tasks involving response interference and working memory. Building on this research, we developed a paradigm in which subjects, after learning to press certain buttons when presented with certain letters, are presented with two action-related letters (the memoranda) but must withhold responding (4 s) until cued to emit the response associated with only one of the two letters. In the Congruent condition, the action corresponds to the cue (e.g., memoranda = AB, cue = B, response = B); in the Incongruent condition, the action corresponds to the other item of the memoranda (e.g., memoranda = AB, cue = B, response = A). After each trial, subjects inputted a rating regarding their subjectively experienced “urge to err” on that trial. These introspection-based data revealed that, as found in previous research, urges to err were strongest for incongruent trials. Our findings reveal, first, that subjects can successfully perform this new task, even though it is more complex than that of previous studies, and second, that, in this new paradigm, reliable subjective, metacognitive data can be obtained on a trial-by-trial basis. We hope that our novel paradigm will serve as a foundation for future experimental projects on the relationship between working memory performance and consciousness—an under-explored nexus whose investigation is likely to reveal insights about working memory, cognitive control, and metacognition. PMID:27445897

  17. Clinical trials update of the European Organization for Research and Treatment of Cancer Breast Cancer Group

    International Nuclear Information System (INIS)

    The present clinical trial update consists of a review of two of eight current studies (the 10981-22023 AMAROS trial and the 10994 p53 trial) of the European Organization for Research and Treatment of Cancer Breast Cancer Group, as well as a preview of the MIND-ACT trial. The AMAROS trial is designed to prove equivalent local/regional control for patients with proven axillary lymph node metastasis by sentinel node biopsy if treated with axillary radiotherapy instead of axillary lymph node dissection, with reduced morbidity. The p53 trial started to assess the potential predictive value of p53 using a functional assay in yeast in patients with locally advanced/inflammatory or large operable breast cancer prospectively randomised to a taxane regimen versus a nontaxane regimen

  18. The making of the Single European Act

    OpenAIRE

    Budden, Philip Marcus.

    1994-01-01

    This thesis is a contemporary history of one episode in the United Kingdom's experience of the European Community (EC). It charts the making of the Single European Act (SEA) from its early 1980s' origins, through the bargaining process of the Dooge Committee and 1985 intergovernmental conference (IGC), to the SEA itself. By studying the origins of a specific treaty, the thesis analyses the impact of EC membership on one west European nation state and places the histor...

  19. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2005-04-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity. prous.com. This issue focuses on the following selection of drugs: ABX-IL-8, Acclaim, adalimumab, AGI-1067, alagebrium chloride, alemtuzumab, Alequel, Androgel, anti-IL-12 MAb, AOD-9604, aripiprazole, atomoxetine hydrochloride; Biphasic insulin aspart, bosentan, botulinum toxin type B, bovine lactoferrin, brivudine; Cantuzumab mertansine, CB-1954, CDB-4124, CEA-TRICOM, choriogonadotropin alfa, cilansetron, CpG-10101, CpG-7909, CTL-102, CTL-102/CB-1954; DAC:GRF, darbepoetin alfa, davanat-1, decitabine, del-1 Genemedicine, dexanabinol, dextofisopam, dnaJP1, dronedarone hydrochloride, dutasteride; Ecogramostim, eletriptan, emtricitabine, EPI-hNE-4, eplerenone, eplivanserin fumarate, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, etoricoxib, ezetimibe; Falecalcitriol, fingolimod hydrochloride; Gepirone hydrochloride; HBV-ISS, HSV-2 theracine, human insulin; Imatinib mesylate, Indiplon, insulin glargine, ISAtx-247; L612 HuMAb, levodopa/carbidopa/entacapone, lidocaine/prilocaine, LL-2113AD, lucinactant, LY-156735; Meclinertant, metelimumab, morphine hydrochloride, morphine-6-glucuronide; Natalizumab, nimotuzumab, NX-1207, NYVAC-HIV C; Omalizumab, onercept, osanetant; PABA, palosuran sulfate, parathyroid hormone (human recombinant), parecoxib sodium, PBI-1402, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, PINC, pregabalin; Ramelteon, rasagiline mesilate, rasburicase, rimonabant hydrochloride, RO-0098557, rofecoxib, rosiglitazone maleate/metformin hydrochloride; Safinamide mesilate, SHL-749, sitaxsentan sodium, sparfosic acid, SprayGel, squalamine, St. John's Wort

  20. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2009-09-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: AAV1/SERCA2a, Abacavir sulfate/lamivudine, Adalimumab, Aliskiren fumarate, Ambrisentan, Aripiprazole, AT-7519, Atazanavir sulfate, Atomoxetine hydrochloride, Azacitidine, Azelnidipine; Besifloxacin hydrochloride, Bevacizumab, Bioabsorbable everolimus-eluting coronary stent, Bortezomib, Bosentan, Budesonide/formoterol fumarate; CAIV-T, Carisbamate, Casopitant mesylate, Certolizumab pegol, Cetuximab, Ciclesonide, Ciprofloxacin/dexamethasone, CTCE-9908; Dalcetrapib, Darunavir, Deferasirox, Desloratadine, Disitertide, Drotrecogin alfa (activated), DTA-H19, Duloxetine hydrochloride, Dutasteride; Ecogramostim, Efalizumab, Emtricitabine, Eribulin mesilate, Escitalopram oxalate, Eszopiclone, EUR-1008, Everolimus-eluting coronary stent, Exenatide; Fampridine, Fluticasone furoate, Formoterol fumarate/fluticasone propionate, Fosamprenavir calcium, Fulvestrant; Gabapentin enacarbil, GS-7904L; HPV-6/11/16/18, Human Secretin, Hydralazine hydrochloride/isosorbide dinitrate; Imatinib mesylate, Imexon, Inalimarev/Falimarev, Indacaterol, Indacaterol maleate, Inhalable human insulin, Insulin detemir, Insulin glargine, Ixabepilone; L-Alanosine, Lapatinib ditosylate, Lenalidomide, Levocetirizine dihydrochloride, Liraglutide, Lisdexamfetamine mesilate, Lopinavir, Loratadine/montelukast sodium, Lutropin alfa; MeNZB, Mepolizumab, Micafungin sodium, Morphine hydrochloride; Nabiximols, Nikkomycin Z; Olmesartan medoxomil, Omalizumab; Paclitaxel-eluting stent, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Perifosine, PF-489791, Plitidepsin, Posaconazole, Pregabalin; QAX-576; Raltegravir potassium, Ramelteon, Rasagiline

  1. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2010-11-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Thomson Reuters Integrity(SM), the drug discovery and development portal, http://www.thomsonreutersintegrity.com. This issue focuses on the following selection of drugs: Abatacept, Adalimumab, AdCD40L, Adefovir, Aleglitazar, Aliskiren fumarate, AM-103, Aminolevulinic acid methyl ester, Amlodipine, Anakinra, Aprepitant, Aripiprazole, Atazanavir sulfate, Axitinib; Belimumab, Bevacizumab, Bimatoprost, Bortezomib, Bupropion/naltrexone; Calcipotriol/betamethasone dipropionate, Certolizumab pegol, Ciclesonide, CYT-997; Darbepoetin alfa, Darunavir, Dasatinib, Desvenlafaxine succinate, Dexmethylphenidate hydrochloride cogramostim; Eltrombopag olamine, Emtricitabine, Escitalopram oxalate, Eslicarbazepine acetate, Eszopiclone, Etravirine, Everolimus-eluting coronary stent, Exenatide, Ezetimibe; Fenretinide, Filibuvir, Fludarabine; Golimumab; Hepatitis B hyperimmunoglobulin, HEV-239, HP-802-247, HPV-16/18 AS04, HPV-6/11/16/18, Human albumin, Human gammaglobulin; Imatinib mesylate, Inotuzumab ozogamicin, Invaplex 50 vaccine; Lapatinib ditosylate, Lenalidomide, Liposomal doxorubicin, Lopinavir, Lumiliximab, LY-686017; Maraviroc, Mecasermin rinfabate; Narlaprevir; Ocrelizumab, Oral insulin, Oritavancin, Oxycodone hydrochloride/naloxone; Paclitaxel-eluting stent, Palonosetron hydrochloride, PAN-811, Paroxetine, Pazopanib hydrochloride, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Pitavastatin calcium, Posaconazole, Pregabalin, Prucalopride succinate; Raltegravir potassium, Ranibizumab, RHAMM R3 peptide, Rosuvastatin calcium; Salclobuzic acid sodium salt, SCY-635, Selenate sodium, Semapimod hydrochloride, Silodosin, Siltuximab, Silybin, Sirolimus-eluting stent, SIR-Spheres, Sunitinib malate; Tapentadol hydrochloride, Tenofovir disoproxil

  2. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2008-10-01

    Gateways to clinical trials is a guide to the most recent trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (+)-Dapoxetine hydrochloride, (S)-Tenatoprazole sodium salt monohydrate 19-28z, Acotiamide hydrochloride hydrate, ADV-TK, AE-37, Aflibercept, Albinterferon alfa-2b, Aliskiren fumarate, Asenapine maleate, Axitinib; Bavituximab, Becatecarin, beta-1,3/1,6-Glucan, Bevacizumab, Bremelanotide; Calcipotriol/betamethasone dipropionate, Casopitant mesylate, Catumaxomab, CDX-110, Cediranib, CMD-193, Cositecan; Darinaparsin, Denosumab, DP-b99, Duloxetine hydrochloride; E75, Ecogramostim, Elacytarabine, EMD-273063, EndoTAG-1, Enzastaurin hydrochloride, Eplerenone, Eribulin mesilate, Esomeprazole magnesium, Etravirine, Everolimus, Ezetimibe; Faropenem daloxate, Febuxostat, Fenretinide; Ghrelin (human); I-131 ch-TNT-1/B, I-131-3F8, Iclaprim, Iguratimod, Iloperidone, Imatinib mesylate, Inalimarev/Falimarev, Indacaterol, Ipilimumab, Iratumumab, Ispinesib mesylate, Ixabepilone; Lapatinib ditosylate, Laquinimod sodium, Larotaxel dehydrate, Linezolid, LOR-2040; Mapatumumab, MKC-1, Motesanib diphosphate, Mycophenolic acid sodium salt; NK-012; Olanzapine pamoate, Oncolytic HSV, Ortataxel; Paclitaxel nanoparticles, Paclitaxel poliglumex, Paliperidone palmitate, Panitumumab, Patupilone, PCV-9, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pertuzumab, Picoplatin, Pimavanserin tartrate, Pimecrolimus, Plerixafor hydrochloride, PM-02734, Poly I:CLC, PR1, Prasugrel, Pregabalin, Progesterone caproate, Prucalopride, Pumosetrag hydrochloride; RAV-12, RB-006, RB-007, Recombinant human erythropoietin alfa, Rimonabant, Romidepsin; SAR-109659, Satraplatin, Sodium butyrate; Tadalafil, Talampanel, Tanespimycin, Tarenflurbil, Tariquidar

  3. Isolated effects of number of acquisition trials on extinction of rat conditioned approach behavior.

    Science.gov (United States)

    Gottlieb, Daniel A; Prince, Emily B

    2012-05-01

    Four conditioned approach experiments with rats assessed for effects of number of acquisition trials on extinction of conditioned responding, when number of acquisition sessions and total acquisition time were held constant. In Experiment 1, 32 trials per acquisition session led to more extinction responding than did 1 or 2 trials per session but less than did 4 trials per session. In Experiment 2, 2 trials per acquisition session led to more spontaneous recovery than did 32 trials per session. These latter findings are reminiscent of the overtraining extinction effect (OEE). Experiment 3 attempted to reduce the OEE with a preconditioning phase of partial reinforcement. Experiment 4 attempted to reduce the beneficial within-subject effects of increasing the number of acquisition trials on extinction observed by Gottlieb and Rescorla (2010) by extinguishing stimuli in different sessions. Overall, results suggest a procedural asymmetry: between-subject, increasing the number of trials between any pair of trials does not lead to greater persistence of responding during extinction; within-subject, it does. Results are discussed from an associative perspective, with a focus on explanations involving either frustration or comparator mechanisms, and from an information processing perspective, with a focus on Rate Estimation Theory. PMID:22475497

  4. African HIV/AIDS trials are more likely to report adequate allocation concealment and random generation than North American trials.

    Directory of Open Access Journals (Sweden)

    Nandi Siegfried

    noteworthy. Most African trials are externally funded, and it is possible that stricter agency requirements when leading trials in other countries and greater experience and training of principal investigators of an international stature, may account for this difference.

  5. 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....

  6. The CHANGE trial

    DEFF Research Database (Denmark)

    Speyer, Helene; Christian Brix Nørgaard, Hans; Birk, Merete;

    2016-01-01

    Life expectancy in patients with schizophrenia is reduced by 20 years for men and 15 years for women compared to the general population. About 60% of the excess mortality is due to physical illnesses, with cardiovascular disease being dominant. CHANGE was a randomized, parallel-group, superiority...... cardiorespiratory fitness, physical activity, weight, diet and smoking. In conclusion, the CHANGE trial did not support superiority of individual lifestyle coaching or care coordination compared to treatment as usual in reducing cardiovascular risk in patients with schizophrenia spectrum disorders and abdominal...

  7. FDAAA legislation is working, but methodological flaws undermine the reliability of clinical trials: a cross-sectional study

    OpenAIRE

    Marin dos Santos, Douglas H.; Atallah, Álvaro N.

    2015-01-01

    The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide publicly access to a broad range of biomedical information to be made available on the ...

  8. Progesterone neuroprotection: The background of clinical trial failure.

    Science.gov (United States)

    Schumacher, Michael; Denier, Christian; Oudinet, Jean-Paul; Adams, David; Guennoun, Rachida

    2016-06-01

    Since the first pioneering studies in the 1990s, a large number of experimental animal studies have demonstrated the neuroprotective efficacy of progesterone for brain disorders, including traumatic brain injury (TBI). In addition, this steroid has major assets: it easily crosses the blood-brain-barrier, rapidly diffuses throughout the brain and exerts multiple beneficial effects by acting on many molecular and cellular targets. Moreover, progesterone therapies are well tolerated. Notably, increased brain levels of progesterone are part of endogenous neuroprotective responses to injury. The hormone thus emerged as a particularly promising protective candidate for TBI and stroke patients. The positive outcomes of small Phase 2 trials aimed at testing the safety and potential protective efficacy of progesterone in TBI patients then provided support and guidance for two large, multicenter, randomized and placebo-controlled Phase 3 trials, with more than 2000 TBI patients enrolled. The negative outcomes of both trials, named ProTECT III and SyNAPSE, came as a big disappointment. If these trials were successful, progesterone would have become the first efficient neuroprotective drug for brain-injured patients. Thus, progesterone has joined the numerous neuroprotective candidates that have failed in clinical trials. The aim of this review is a reappraisal of the preclinical animal studies, which provided the proof of concept for the clinical trials, and we critically examine the design of the clinical studies. We made efforts to present a balanced view of the strengths and limitations of the translational studies and of some serious issues with the clinical trials. We place particular emphasis on the translational value of animal studies and the relevance of TBI biomarkers. The probability of failure of ProTECT III and SyNAPSE was very high, and we present them within the broader context of other unsuccessful trials. PMID:26598278

  9. Gateways to clinical trials.

    Science.gov (United States)

    Bayes, M; Rabasseda, X; Prous, J R

    2002-01-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses, which has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the world's first drug discovery and development portal, providing information on study design, treatments, conclusions and references. This issue focuses on the following selection of drugs: Abacavir sulfate; abciximab; abetimus sodium; adalimumab; aldesleukin; almotriptan; alteplase; amisulpride; amitriptyline hydrochloride; amoxicillin trihydrate; atenolol; atorvastatin calcium; atrasentan; Beclometasone dipropionate; bosentan; Captopril; ceftriaxone sodium; cerivastatin sodium; cetirizine hydrochloride; cisplatin; citalopram hydrobromide; Dalteparin sodium; darusentan; desirudin; digoxin; Efalizumab; enoxaparin sodium; ertapenem sodium; esomeprazole magnesium; estradiol; ezetimibe; Famotidine; farglitazar; fluorouracil; fluticasone propionate; fosamprenavir sodium; Glibenclamide; glucosamine sulfate; Heparin sodium; HSPPC-96; hydrochlorothiazide; Imatinib mesilate; implitapide; Lamivudine; lansoprazole; lisinopril; losartan potassium; l-Propionylcarnitine; Melagatran; metformin hydrochloride; methotrexate; methylsulfinylwarfarin; Nateglinide; norethisterone; Olmesartan medoxomil; omalizumab; omapatrilat; omeprazole; oseltamivir phosphate; oxatomide; Pantoprazole; piperacillin sodium; pravastatin sodium; Quetiapine hydrochloride; Rabeprazole sodium; raloxifene hydrochloride; ramosetron hydrochloride; ranolazine; rasburicase; reboxetine mesilate; recombinant somatropin; repaglinide; reteplase; rosiglitazone; rosiglitazone maleate; rosuvastatin calcium; Sertraline; simvastatin; sumatriptan succinate; Tazobactam sodium; tenecteplase; tibolone; tinidazole; tolterodine tartrate; troglitazone; Uniprost; Warfarin sodium; Ximelagatran. PMID:11980386

  10. Choosing a control intervention for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Djulbegovic Benjamin

    2003-04-01

    Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

  11. THE LANGUAGE OF LEGISLATIVE ACTS

    Directory of Open Access Journals (Sweden)

    Галина Викторовна Томсон

    2013-07-01

    Full Text Available Teaching language for specific purposes is the basis of the MGIMO Bachelors’ and Masters’ language education. However, it is experts on language and teaching rather than specialists in the sphere of law that are engaged in this work. The author of this article shares her experience of mastering a new specialization and applying her linguistic knowledge to it.It is creating educational resources that requires not only careful selection of authentic texts, defining specialized lexical base, but also viewing these texts as a complex syntactic whole, possessing its own structure and constituting a language unit that can be modeled. Linguistic perception of specialized texts facilitates the creation of practice-oriented educational resources, the application of which results in university graduates’ ability to use the language of their profession properly.The main conclusion from the results presented in this research shows that the dependent clauses act as the limiting ones. This allows you to add unambiguity and clarity to professional language. Simultaneous accesses to the world of reality and the world of language explains its primary role in verbal and cogitative human activity and puts the sentence as the basic unit of speech in the center of the "language - thinking" system, relating thought and language structures in the overall implementation of the communicative function of language.DOI: http://dx.doi.org/10.12731/2218-7405-2013-6-6

  12. Reporting quality of social and psychological intervention trials: a systematic review of reporting guidelines and trial publications.

    Directory of Open Access Journals (Sweden)

    Sean P Grant

    Full Text Available BACKGROUND: Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. OBJECTIVE/DESIGN: We conducted a two-part study that reviewed (1 reporting guidelines for and (2 the reporting quality of social and psychological intervention trials. DATA SOURCES: (1 To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2 To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. ELIGIBILITY: (1 Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2 Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes. RESULTS: (1 We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2 Our review of trials (n = 239 revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information and abstracts (55%; information about blinding (15%, sequence generation (23%, and allocation concealment (17%; and details about actual delivery of experimental (43% and control interventions (34%, participant uptake (25%, and service environment (28%. Only 11 of 40 journals referenced reporting guidelines in "Instructions to Authors." CONCLUSION: Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely

  13. Design and implementation of clinical trials in rehabilitation research.

    Science.gov (United States)

    Hart, Tessa; Bagiella, Emilia

    2012-08-01

    The growth of evidence-based medicine means that both researchers and clinicians must grasp the complex issues involved in implementing clinical trials, which are especially challenging for the behavioral (experience-based) treatments that predominate in rehabilitation. In this article we discuss selected issues germane to the design, implementation, and analysis of group-level clinical trials in rehabilitation. We review strengths, weaknesses, and best applications of 1-sample, between-subjects, and within-subjects study designs, including newer models such as practical clinical trials and point-of-care trials. We also discuss the selection of appropriate control conditions against which to test rehabilitation treatments, as well as issues related to trial blinding. In a section on treatment definition, we discuss the challenges of specifying the active ingredients in the complex interventions that are widely used in rehabilitation, and present an illustration of 1 approach to defining treatments via the learning mechanisms that underlie them. Issues related to treatment implementation are also discussed, including therapist allocation and training, and assessment of treatment fidelity. Finally we consider 2 statistical topics of particular importance to many rehabilitation trials: the use of multiple or composite outcomes, and factors that must be weighed in estimating sample size for clinical trials.

  14. Gateways to clinical trials.

    Science.gov (United States)

    Bayes, M; Rabasseda, X; Prous, J R

    2005-01-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (-)-Epigallocatechin gallate; ACP-103, Ad.Egr.TNF.11 D, adalimumab, AF-IL 12, AIDSVAX gp120 B/B, alefacept, alemtuzumab, a-Galactosylceramide, ALVAC vCP 1452, alvimopan hydrate, alvocidib hydrochloride, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, anakinra, anidulafungin, antarelix, aprepitant, aripiprazole, arsenic sulfide, asoprisnil, atazanavir sulfate, atomoxetine hydrochloride; Bevacizumab, bimatoprost, BMS-184476, bortezomib, bosentan, botulinum toxin type B, BrachySil, brivudine; Caffeine, calcipotriol/betamethasone dipropionate, cannabidiol, capsaicin for injection, caspofungin acetate, CC-4047, cetuximab, CGP-36742, clofazimine, CpG-7909, Cypher; Darbepoetin alfa, dextromethorphan/quinidine sulfate, dimethylfumarate, dronabinol/cannabidiol, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Ecogramostim, efalizumab, eletriptan, emtricitabine, enfuvirtide, eplerenone, esomeprazole magnesium, estradiol acetate, eszopiclone, etoricoxib, exenatide, ezetimibe, ezetimibe/simvastatin; Fampridine, fondaparinux sodium, fosamprenavir calcium; Gefitinib, GPI-0100; hA 20, HTU-PA, human insulin, HuOKT 3 gamma 1(Ala 234-Ala 235), hyaluronic acid; Icatibant, imatinib mesylate, Indiplon, INKP-100, INKP-102, iodine (I131) tositumomab, istradefylline, IV gamma-globulin, ivabradine hydrochloride, ixabepilone; Lacosamide, landiolol, lanthanum carbonate, lasofoxifene tartrate, LB-80380, lenalidomide, lidocaine/tetracaine, linezolid, liposomal doxorubicin, liposomal vincristine sulfate, lopinavir, lopinavir/ritonavir, lumiracoxib, lurtotecan; Maribavir, morphine glucuronide, MVA-5 T

  15. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2008-09-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com.This issue focuses on the following selection of drugs: ABT-263, AC-2307, Aclidinium bromide, Adefovir dipivoxil, ADH-1, Agatolimod sodium, Alefacept, Aliskiren fumarate, Aminolevulinic acid methyl ester, Anakinra, Apaziquone, Aprepitant, Aripiprazole, ASM-8, Atiprimod hydrochloride, AVE-0277, AVE-1642, AVE-8062, Axitinib, Azacitidine, AZD-0530; Bazedoxifene acetate, Bevacizumab, Bexarotene, BI-2536, Biphasic insulin aspart, BMS-387032, BMS-663513, Bortezomib, BQ-123, Brivanib alaninate, BSI-201; Caspofungin acetate, CDX-110, Cetuximab, Ciclesonide, CR-011, Cypher; Daptomycin, Darbepoetin alfa, Dasatinib, Decitabine, Deferasirox, Denosumab, Dexlansoprazole, Dexmethylphenidate hydrochloride, DNA-Hsp65 vaccine, Dovitinib, Drotrecogin alfa (activated), DTaP-HBV-IPV/Hibvaccine, DTaP-IPV-HB-PRP-T, Duloxetine hydrochloride, Dutasteride; Ecogramostim, Elacytarabine, Emtricitabine, Endothelin, Entecavir, Eplivanserin fumarate, Escitalopram oxalate, Everolimus, Ezetimibe, Ezetimibe/simvastatin; Farletuzumab, Fesoterodine fumarate, Fibrin sealant (human), Fulvestrant; Gefitinib, Gemtuzumab ozogamicin, Glufosfamide, GSK-1562902A; Hib-TT; Imatinib mesylate, IMC-11F8, Imidazoacridinone, IMP-321, INCB-18424, Indiplon, Indisulam, INNO-406, Irinotecan hydrochloride/Floxuridine, ITF-2357, Ixabepilone; KRN-951; Lasofoxifene tartrate; Lenalidomide, LGD-4665, Lonafarnib, Lubiprostone, Lumiliximab; MDX-1100, Melan-A/MART-1/gp100/IFN-alfa, Methyl-CDDO, Metreleptin, MLN-2704, Mycophenolic acid sodium salt; Na-ASP-2, Naproxcinod, Nilotinib hydrochloride monohydrate, NPI-2358; Oblimersen sodium, Odanacatib; Paclitaxel nanoparticles, PAN-811, Panobinostat, PBI-1402, PC-515, Peginterferon alfa

  16. Conducting qualitative research within Clinical Trials Units: avoiding potential pitfalls.

    Science.gov (United States)

    Cooper, Cindy; O'Cathain, Alicia; Hind, Danny; Adamson, Joy; Lawton, Julia; Baird, Wendy

    2014-07-01

    The value of using qualitative research within or alongside randomised controlled trials (RCTs) is becoming more widely accepted. Qualitative research may be conducted concurrently with pilot or full RCTs to understand the feasibility and acceptability of the interventions being tested, or to improve trial conduct. Clinical Trials Units (CTUs) in the United Kingdom (UK) manage large numbers of RCTs and, increasingly, manage the qualitative research or collaborate with qualitative researchers external to the CTU. CTUs are beginning to explicitly manage the process, for example, through the use of standard operating procedures for designing and implementing qualitative research with trials. We reviewed the experiences of two UK Clinical Research Collaboration (UKCRC) registered CTUs of conducting qualitative research concurrently with RCTs. Drawing on experiences gained from 15 studies, we identify the potential for the qualitative research to undermine the successful completion or scientific integrity of RCTs. We show that potential problems can arise from feedback of interim or final qualitative findings to members of the trial team or beyond, in particular reporting qualitative findings whilst the trial is on-going. The problems include: We make recommendations for improving the management of qualitative research within CTUs.

  17. JK '98: Acting responsibly

    International Nuclear Information System (INIS)

    For the first time, a paper delivered at the Annual Nuclear Conference was presented by two authors, the CEO of Bayernwerk AG, Dr. Otto Majewski, and the CEO of the Power Generation Division (KWU) of Siemens AG, Adolf Huettl, reflecting the operators' and the vendors' points of view about the present situation of nuclear power use in Germany and the need to maintain its share in the energy mix. The events associated with shipments of casks for radioactive waste have rekindled the debate about the responsibility of the peaceful use of nuclear power in the nuclear opposition camp. That debate needs to be put back on a factual basis. If no consensus could be achieved now about the use of nuclear power as a whole, at least consensus had to be reached about the future approach to spent fuel and waste management. From the outset, the nuclear industry has shown a high degree of responsibility, developing concepts of using uranium as an energy source in an economically viable and responsible way. It is showing responsibility also in making provision for the future. The safe and economically successful operation of today's nuclear power plants is an important reason for developing new reactor concepts. That development of new rector lines depends critically on the preservation and advancement of specialized knowledge. Know-how needs to be preserved and developed further not only for future nuclear power plants but also for the plants existing now, which still have service lives of several decades. Sustainable energy supply requires all sources of energy to be exploited, especially those which do not generate carbon dioxide. All the options currently known must be kept open and preserved, respectively, for coming generations. Acting responsibly means adding to the choices available. (orig.)

  18. [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.

  19. The Price-Anderson Act

    International Nuclear Information System (INIS)

    The Price-Anderson Act establishes nuclear liability law in the United States. First passed in 1957, it has influenced other nuclear liability legislation around the world. The insurer response the nuclear accident at Three Mile Island in 1979 demonstrates the application of the Act in a real life situation. The Price-Anderson Act is scheduled to be renewed in 2002, and the future use of commercial nuclear power in tge United States will be influenced by this renewal. (author)

  20. Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis

    OpenAIRE

    Ross, Joseph S.; Mulvey, Gregory K.; Hines, Elizabeth M.; Nissen, Steven E.; Krumholz, Harlan M.

    2009-01-01

    Editors' Summary Background People assume that whenever they are ill, health care professionals will make sure they get the best available treatment. But how do clinicians know which treatment is most appropriate? In the past, clinicians used their own experience to make treatment decisions. Nowadays, they rely on evidence-based medicine—the systematic review and appraisal of the results of clinical trials, studies that investigate the efficacy and safety of medical interventions in people. H...

  1. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

    OpenAIRE

    Ross, Joseph S.; Mulvey, Gregory K.; Hines, Elizabeth M.; Steven E. Nissen; Krumholz, Harlan M.

    2009-01-01

    Editors' Summary Background People assume that whenever they are ill, health care professionals will make sure they get the best available treatment. But how do clinicians know which treatment is most appropriate? In the past, clinicians used their own experience to make treatment decisions. Nowadays, they rely on evidence-based medicine—the systematic review and appraisal of the results of clinical trials, studies that investigate the efficacy and safety of medical interventions in people. H...

  2. Atomic Energy Authority Act 1971

    International Nuclear Information System (INIS)

    This Act provides for the transfer of property, rights, liabilities and obligations of parts of the undertaking of the United Kingdom Atomic Energy Autority, to two new Compagnies set up for this purpose: the Bristish Nuclear Fuels Limited, and the Radiochemical Centre Limited. Patents licences and registered designs owned by the Autority at the time of the transfer are not included therein. The Act also includes amendments to the Nuclear Installations Act 1965, notably as regards permits to operate granted to a body corporate. Finally, the Schedule to this Act lays down a certain number of provisions relating to security and the preservation of secrets. (NEA)

  3. Trial encoding algorithms ensemble.

    Science.gov (United States)

    Cheng, Lipin Bill; Yeh, Ren Jye

    2013-01-01

    This paper proposes trial algorithms for some basic components in cryptography and lossless bit compression. The symmetric encryption is accomplished by mixing up randomizations and scrambling with hashing of the key playing an essential role. The digital signature is adapted from the Hill cipher with the verification key matrices incorporating un-invertible parts to hide the signature matrix. The hash is a straight running summation (addition chain) of data bytes plus some randomization. One simplified version can be burst error correcting code. The lossless bit compressor is the Shannon-Fano coding that is less optimal than the later Huffman and Arithmetic coding, but can be conveniently implemented without the use of a tree structure and improvable with bytes concatenation.

  4. Implementation of blinded outcome assessment in the Effective Verruca Treatments trial (EverT) – lessons learned

    OpenAIRE

    Cockayne, Sarah; Hewitt, Catherine; Hashmi, Farina; Hicks, Kate; Concannon, Michael; McIntosh, Caroline; Thomas, Kim; Hall, Jill; Watson, Judith; Torgerson, David; Watt, Ian

    2016-01-01

    Background Trials using inadequate levels of blinding may report larger effect sizes than blinded studies. It has been suggested that blinded outcome assessment in open trials may in some cases be undertaken by assessments of photographs. The aim of this paper is to explore the effect of using different methods to assess the primary outcome in the EVerT (Effective Verruca Treatments) trial. It also aims to give an overview of the experiences of using digital photographs within the trial. Meth...

  5. 75 FR 63703 - Privacy Act of 1974; Privacy Act Regulation

    Science.gov (United States)

    2010-10-18

    ... Federal Register, 73 FR 25594, May 7, 2008. The proposed amendments: (1) Waived all copying fees in..., 73 FR 54595, September 22, 2008, certain portions of BGFRS-37 (Electronic Applications) may be exempt... CFR Part 261a Privacy Act of 1974; Privacy Act Regulation AGENCY: Board of Governors of the...

  6. Using the Internet to search for cancer clinical trials: a comparative audit of clinical trial search tools.

    Science.gov (United States)

    Atkinson, Nancy L; Saperstein, Sandra L; Massett, Holly A; Leonard, Colleen Ryan; Grama, Lakshmi; Manrow, Rick

    2008-07-01

    Advancing the clinical trial research process to improve cancer treatment necessitates helping people with cancer identify and enroll in studies, and researchers are using the power of the Internet to facilitate this process. This study used a content analysis of online cancer clinical trial search tools to understand what people with cancer might encounter. The content analysis revealed that clinical trial search tools were easy to identify using a popular search engine, but their functionality and content varied greatly. Most required that users be fairly knowledgeable about their medical condition and sophisticated in their web navigation skills. The ability to search by a specific health condition or type of cancer was the most common search strategy. The more complex tools required that users input detailed information about their personal medical history and have knowledge of specific clinical trial terminology. Search tools, however, only occasionally advised users to consult their doctors regarding clinical trial decision-making. This, along with the complexity of the tools suggests that online search tools may not adequately facilitate the clinical trial recruitment process. Findings from this analysis can be used as a framework from which to systematically examine actual consumer experience with online clinical trial search tools.

  7. 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.

  8. The Danish Cardiovascular Screening Trial (DANCAVAS)

    DEFF Research Database (Denmark)

    Diederichsen, Axel Cosmus Pyndt; Rasmussen, Lars Melholt; Søgaard, Rikke;

    2015-01-01

    to cardiovascular seven-faceted screening examinations at one of four locations. The screening will include: (1) low-dose non-contrast CT scan to detect coronary artery calcification and aortic/iliac aneurysms, (2) brachial and ankle blood pressure index to detect peripheral arterial disease and hypertension, (3...... numbered 67+ will be offered screening; the others will act as a control group. BLINDING: Only those randomized to the screening will be invited to the examination;the remaining participants will not. Numbers randomized: A total of 45,000 men will be randomized 1:2. Recruitment: Enrollment started October....../iliac aneurysms) and measurements of the ankle brachial blood pressure index (ABI) as part of a multifocal screening and intervention program for CVD in men aged 65-74. Attendance rate and compliance to initiated preventive actions must be expected to become of major importance. TRIAL REGISTRATION: Current...

  9. Defendants' Rights in Criminal Trials.

    Science.gov (United States)

    Martin, Ralph C., II; Keeley, Elizabeth

    1997-01-01

    Reviews the protections afforded by the Constitution for defendants in criminal trials. These include the right to a jury trial (in cases of possible incarceration), an impartial jury, and the requirement of a unanimous verdict. Defends the use of plea bargaining as essential to an efficient criminal justice system. (MJP)

  10. Randomized clinical trials in HEPATOLOGY

    DEFF Research Database (Denmark)

    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998...

  11. Topics in clinical trial management

    NARCIS (Netherlands)

    B.A. Kirwan (Bridget Anne)

    2004-01-01

    textabstractThe aim of this thesis is to show how clinical trial conduct can be managed while respecting the underlying scientific principles. Chapter 2 describes the main results of PICO (PImobendan in COngestive heart failure), a trial which investigated a positive inotropic agent in patients with

  12. Unique perception of clinical trials by Korean cancer patients

    Directory of Open Access Journals (Sweden)

    Lee Su Jin

    2012-12-01

    Full Text Available Abstract Background In the past few years, the number of clinical trials has increased rapidly in East Asia, especially for gastric and hepatobiliary cancer that are prevalent in Asian populations. However, the actual degree of understanding or perceptions of clinical trials by cancer patients in East Asian countries have seldom been studied. Methods Between July 1st and November 30th of 2011, we conducted a prospective study to survey cancer patients regarding their awareness of, and willingness to participate in, a clinical trial. Patients with gastrointestinal/hepatobiliary cancer who visited the Hematology-Oncology outpatient clinic at Samsung Medical Center (SMC were enrolled. A total of 21 questions were asked including four questions which used the Visual analogue scale (VAS score. Results In this survey study, 1,000 patients were asked to participate and 675 patients consented to participate (67.5%. The awareness of clinical trials was substantially higher in patients who had a higher level of education (pp=0.004, and had a higher economic status (p=0.001. However, the willingness to participate in a clinical trial was not affected by the level of education or economic status of patients. The most influential factors for patient willingness to participate were a physician recommendation (n=181, 26.8%, limited treatment options (n=178, 26.4%, and expectations of effectiveness of new anti-cancer drugs (n=142, 21.0%. Patients with previous experience in clinical trials had a greater willingness to participate in clinical trials compared to patients without previous experience (p Conclusions This large patient cohort survey study showed that Korean cancer patients are more aware of clinical trials, but awareness did not translate into willingness to participate.

  13. Long-term dietary intervention trials: critical issues and challenges

    Directory of Open Access Journals (Sweden)

    Crichton Georgina E

    2012-07-01

    Full Text Available Abstract Background There are many challenges involved in running randomised controlled dietary intervention trials that investigate health outcomes. The aim of this paper was to evaluate the recruitment process, retention of participants and challenges faced in our dairy intervention trial, and to provide strategies to combat the difficulties of running long-term dietary intervention trials. Methods A 12-month, randomised, two-way crossover study was conducted in overweight adults with habitually low dairy food consumption to assess the effects of a high dairy intake (4 servings of reduced-fat dairy per day compared with a low dairy intake (1 serving of reduced-fat dairy per day on measures of cardiometabolic and cognitive health. On completion of the high dairy intake phase, each participant was interviewed about their experience in the trial and responses were used to evaluate the key issues for study participants. Results Although the recruitment target was achieved, high rates of attrition (49.3% and difficulties maintaining participant compliance (reported by 37.8% of participants were major threats to the viability of the study. Factors that contributed to the high attrition included inability to comply with the dietary requirements of the study protocol (27.0%, health problems or medication changes (24.3% and time commitment (10.8%. Conclusion Attrition and adherence to study requirements present challenges to trials requiring longer-term dietary change. Including a run-in period to further assess the motivation, commitment and availability of participants, maintaining regular contact with participants during control phases, minimising time commitment, providing flexibility with dietary requirements, facilitating positive experiences, and stringent monitoring of diet are some key recommendations for future dietary intervention trials. Trial registration Australia and New Zealand Clinical Trials Registry (ACTRN 12608000538347

  14. Food environments are relevant to recruitment and adherence in dietary modification trials

    OpenAIRE

    Feathers, Alexandra; Aycinena, Ana C.; Lovasi, Gina S.; Rundle, Andrew; Gaffney, Ann Ogden; Richardson, John; Hershman, Dawn; Koch, Pam; Contento, Isobel; Greenlee, Heather

    2015-01-01

    Few studies have examined the built environment's role in recruitment to and adherence in dietary intervention trials. Using data from a randomized dietary modification trial of urban Latina breast cancer survivors, we tested the hypotheses that neighborhood produce access could act as a potential barrier and/or facilitator to recruitment, and that a participant's produce availability would be associated with increased fruit/vegetable intake, one of the intervention's targets. Eligible women ...

  15. 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.

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... years of experiments in the laboratory and in animals before they even consider testing an experimental treatment in people. Most of this early research occurs at universities and medical centers across the country. The National Institutes of ...

  17. Participating in Clinical Trials

    Science.gov (United States)

    ... for more information Scientists usually do years of experiments in the laboratory and in animals before they even consider testing an experimental treatment in people. Most of this early research occurs at universities and medical centers across the ...

  18. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... the best treatment for a disease evaluate treatment methods such as surgical techniques, psychiatric therapy, or radiotherapy. Click for more information Scientists usually do years of experiments in the laboratory ...

  19. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... for more information Scientists usually do years of experiments in the laboratory and in animals before they ... of caregivers, support groups, and various types of social interventions. Supportive care interventions are not intended to ...

  20. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... years of experiments in the laboratory and in animals before they even consider testing an experimental treatment in people. Most of this early research occurs at universities and medical centers across the ...

  1. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... years of experiments in the laboratory and in animals before they even consider testing an experimental treatment ... gathers more information about safety and effectiveness, studying different populations and different dosages and using the drug ...

  2. Robust Single Trial Identification of Conscious Percepts Triggered by Sensory Events of Variable Saliency

    OpenAIRE

    Marta Teixeira; Gabriel Pires; Miguel Raimundo; Sérgio Nascimento; Vasco Almeida; Miguel Castelo-Branco

    2014-01-01

    The neural correlates of visual awareness are elusive because of its fleeting nature. Here we have addressed this issue by using single trial statistical ‘‘brain reading’’ of neurophysiological event related (ERP) signatures of conscious perception of visual attributes with different levels of saliency. Behavioral reports were taken at every trial in 4 experiments addressing conscious access to color, luminance, and local phase offset cues. We found that single trial neurophysiologic...

  3. Early-phase clinical trials of anti-HIV Drugs——understanding and discussion

    Institute of Scientific and Technical Information of China (English)

    2009-01-01

    Innovative anti-HIV drugs developed by local sponsors in China have come into the stage of early-phase clinical trials.How to systemically design the clinical trials of innovative anti-HIV drugs still remains a challenge for them.This article references the literature and the experience of reviewers,to introduce general considerations concerning early-phase clinical trials of innovative anti-HIV drugs.

  4. Early-phase clinical trials of anti-HIV Drugs——understanding and discussion

    Institute of Scientific and Technical Information of China (English)

    LI YaJie; ZHAO Ming; ZHAO DeHeng

    2009-01-01

    Innovative anti-HIV drugs developed by local sponsors in China have come into the stage of early-phase clinical trials. How to systemically design the clinical trials of innovative anti-HIV drugs still remains a challenge for them. This article references the literature and the experience of reviewers, to introduce general considerations concerning early-phase clinical trials of innovative anti-HIV drugs.

  5. Nuclear Material (Offences) Act 1983

    International Nuclear Information System (INIS)

    The main purpose of this Act is to enable the United Kingdom to ratify the Convention on the Physical Protection of Nuclear Material which opened for signature at Vienne and New York on 3 March 1980. The Act extends throughout the United Kingdom. (NEA)

  6. Atomic Energy Commission Act, 1963

    International Nuclear Information System (INIS)

    Promulgated in 1963, the Atomic Energy Commission Act (204) established and vested in the Ghana Atomic Energy Commission the sole responsibility for all matters relating to the peaceful uses of atomic energy in the country. Embodied in the Act are provisions relating to the powers, duties, rights and liabilities of the Commission. (EAA)

  7. The Environmental Protection Act authorization and experience to date

    Energy Technology Data Exchange (ETDEWEB)

    Harrison, D.A. [British Steel plc, Scunthorpe (United Kingdom)

    1994-12-31

    The six coke oven authorizations now in force in British Steel were issued during the summer of 1993. The paper outlines the four major duties of the operator set out in the authorization document which refer to good maintenance of equipment and management of personnel, sampling and monitoring procedures, maintaining records and notification of any contravention of the authorised conditions. Part 5 of the authorization concerns the improvement programme. Several improvements common at British Steel sites concerning pollution monitoring and control are listed. 5 figs.

  8. Constructing Emotion: The Experience of Fear as a Conceptual Act

    OpenAIRE

    Lindquist, Kristen A; Barrett, Lisa Feldman

    2008-01-01

    This study examined the hypothesis that emotion is a psychological event constructed from the more basic elements of core affect and conceptual knowledge. Participants were primed with conceptual knowledge of fear, conceptual knowledge of anger, or a neutral prime and then proceeded through an affect-induction procedure designed to induce unpleasant, high-arousal affect or a neutral affective state. As predicted, only those individuals for whom conceptual knowledge of fear had been primed exp...

  9. Acting to let someone die.

    Science.gov (United States)

    McGee, Andrew

    2015-02-01

    This paper examines the recent prominent view in medical ethics that withdrawing life-sustaining treatment (LST) is an act of killing. I trace this view to the rejection of the traditional claim that withdrawing LST is an omission rather than an act. Although that traditional claim is not as problematic as this recent prominent view suggests, my main claim is that even if we accepted that withdrawing LST should be classified as an act rather than as an omission, it could still be classified as letting die rather than killing. Even though omissions are contrasted with acts, letting die need not be, for one can let die by means of acts. The remainder of the paper is devoted to establishing this claim and addresses certain objections to it.

  10. Design of clinical trials in acute kidney injury: report from an NIDDK workshop on trial methodology.

    Science.gov (United States)

    Palevsky, Paul M; Molitoris, Bruce A; Okusa, Mark D; Levin, Adeera; Waikar, Sushrut S; Wald, Ron; Chertow, Glenn M; Murray, Patrick T; Parikh, Chirag R; Shaw, Andrew D; Go, Alan S; Faubel, Sarah G; Kellum, John A; Chinchilli, Vernon M; Liu, Kathleen D; Cheung, Alfred K; Weisbord, Steven D; Chawla, Lakhmir S; Kaufman, James S; Devarajan, Prasad; Toto, Robert M; Hsu, Chi-yuan; Greene, Tom; Mehta, Ravindra L; Stokes, John B; Thompson, Aliza M; Thompson, B Taylor; Westenfelder, Christof S; Tumlin, James A; Warnock, David G; Shah, Sudhir V; Xie, Yining; Duggan, Emily G; Kimmel, Paul L; Star, Robert A

    2012-05-01

    Acute kidney injury (AKI) remains a complex clinical problem associated with significant short-term morbidity and mortality and lacking effective pharmacologic interventions. Patients with AKI experience longer-term risks for progressive chronic ESRD, which diminish patients' health-related quality of life and create a larger burden on the healthcare system. Although experimental models have yielded numerous promising agents, translation into clinical practice has been unsuccessful, possibly because of issues in clinical trial design, such as delayed drug administration, masking of therapeutic benefit by adverse events, and inadequate sample size. To address issues of clinical trial design, the National Institute of Diabetes and Digestive and Kidney Diseases sponsored a workshop titled "Clinical Trials in Acute Kidney Injury: Current Opportunities and Barriers" in December 2010. Workshop participants included representatives from academia, industry, and government agencies whose areas of expertise spanned basic science, clinical nephrology, critical care medicine, biostatistics, pharmacology, and drug development. This document summarizes the discussions of collaborative workgroups that addressed issues related to patient selection, study endpoints, the role of novel biomarkers, sample size and power calculations, and adverse events and pilot/feasibility studies in prevention and treatment of AKI. Companion articles outline the discussions of workgroups for model trials related to prevention or treatment of established AKI in different clinical settings, such as in patients with sepsis.

  11. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2005-06-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abiraterone acetate, acyline, adalimumab, adenosine triphosphate, AEE-788, AIDSVAX gp120 B/B, AK-602, alefacept, alemtuzumab, alendronic acid sodium salt, alicaforsen sodium, alprazolam, amdoxovir, AMG-162, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, aminophylline hydrate, anakinra, anecortave acetate, anti-CTLA-4 MAb, APC-8015, aripiprazole, aspirin, atazanavir sulfate, atomoxetine hydrochloride, atorvastatin calcium, atrasentan, AVE-5883, AZD-2171; Betamethasone dipropionate, bevacizumab, bimatoprost, biphasic human insulin (prb), bortezomib, BR-A-657, BRL-55730, budesonide, busulfan; Calcipotriol, calcipotriol/betamethasone dipropionate, calcium folinate, capecitabine, capravirine, carmustine, caspofungin acetate, cefdinir, certolizumab pegol, CG-53135, chlorambucil, ciclesonide, ciclosporin, cisplatin, clofarabine, clopidogrel hydrogensulfate, clozapine, co-trimoxazole, CP-122721, creatine, CY-2301, cyclophosphamide, cypher, cytarabine, cytolin; D0401, darbepoetin alfa, darifenacin hydrobromide, DASB, desipramine hydrochloride, desloratadine, desvenlafaxine succinate, dexamethasone, didanosine, diquafosol tetrasodium, docetaxel, doxorubicin hydrochloride, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Ecallantide, efalizumab, efavirenz, eletriptan, emtricitabine, enfuvirtide, enoxaparin sodium, estramustine phosphate sodium, etanercept, ethinylestradiol, etonogestrel, etonogestrel/ethinylestradiol, etoposide, exenatide; Famciclovir, fampridine, febuxostat, filgrastim, fludarabine phosphate, fluocinolone acetonide, fluorouracil, fluticasone propionate

  12. Act local, think global

    International Nuclear Information System (INIS)

    Tip O'Neill, one of the grand old men of modem US politics, once famously remarked that all politics is local. Like most politicians who succeed on the national stage - and not just in the US - it was a truth he never lost sight of. What is true for politicians is equally true in the communications business. We may increasingly live in a global village, but successful companies - even multi-nationals - forget the importance of local and regional public relations at their peril. Think of Douglas Ivester, the CEO of Coca-Cola at the time of the 1999 Belgian contamination scandal, who allegedly reacted to first reports of the crisis by asking: 'Where the hell is Belgium?' A more appropriate question today - several years after Coke's share price toppled and the CEO was unceremoniously sacked - might be: 'Who the hell is Douglas Nester?' But - to adapt another famous phrase - the fact that communications (and marketing) professionals still need to 'act local' as much as ever before should not blind us to the growing need to 'think global'. In the nuclear industry, as in the world economy generally, increasing global integration is a reality, as are the international nature of the news media and the increasingly global nature of the anti-nuclear pressure groups. Indeed, it was the growing need for a truly global information network to counter these trends, by increasing the overall speed and accuracy of the worldwide nuclear information flow, that led the nuclear community to establish NucNet in 1991. So where exactly is the line between local and regional nuclear communications on the one hand, and global communications on the other? Is there one spin for a regional audience, and another for a global audience? This presentation proposes some guiding principles, by examining the response of nuclear communicators world-wide to the new communications agenda imposed in the wake of the September 11th suicide attacks in the US. NucNet President Doug McRoberts and Executive

  13. Frailty Intervention Trial (FIT

    Directory of Open Access Journals (Sweden)

    Lockwood Keri

    2008-10-01

    Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a

  14. Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    Information about actively enrolling, ongoing, and completed clinical trials of cancer prevention, early detection, and supportive care, including phase I, II, and III agent and action trials and clinical trials management. |

  15. Social media in clinical trials.

    Science.gov (United States)

    Thompson, Michael A

    2014-01-01

    Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape.

  16. The Dynamo Clinical Trial

    Science.gov (United States)

    Ayres, Thomas R.

    2016-04-01

    The Dynamo Clinical Trial evaluates long-term stellar magnetic health through periodic X-ray examinations (by the Chandra Observatory). So far, there are only three subjects enrolled in the DTC: Alpha Centauri A (a solar-like G dwarf), Alpha Cen B (an early K dwarf, more active than the Sun), and Alpha Canis Majoris A (Procyon, a mid-F subgiant similar in activity to the Sun). Of these, Procyon is a new candidate, so it is too early to judge how it will fare. Of the other two, Alpha Cen B has responded well, with a steady magnetic heartbeat of about 8 years duration. The sickest of the bunch, Alpha Cen A, was in magnetic cardiac arrest during 2005-2010, but has begun responding to treatment in recent years, and seems to be successfully cycling again, perhaps achieving a new peak of magnetic health in the 2016 time frame. If this is the case, it has been 20 years since A's last healthful peak, significantly longer than the middle-aged Sun's 11-year magnetic heartbeat, but perhaps in line with Alpha Cen A's more senescent state (in terms of "relative evolutionary age," apparently an important driver of activity). (By the way, don't miss the exciting movie of the Alpha Cen stars' 20-year X-ray dance.)

  17. 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. PMID:19012585

  18. 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.

  19. New Trends in Clinical Trials: A Conversation with Pfizer's Craig Lipset.

    Science.gov (United States)

    Bates, Mary

    2016-01-01

    Technological advances, such as electronic data capture and the prevalence of Wi-Fi connectivity, are driving changes in how clinical trials are conducted and analyzed. As the power to track and analyze data expands, clinical trials are becoming more efficient and objective, and patient experiences are improved. PMID:26978850

  20. The Mock Trial: A Dynamic Exercise for Thinking Critically about Management Theories, Topics, and Practices

    Science.gov (United States)

    Farmer, Kevin; Meisel, Steven I.; Seltzer, Joe; Kane, Kathleen

    2013-01-01

    The Mock Trial is an experiential exercise adapted from a law school process that encourages students to think critically about theories, topics, and the practice of management in an innovative classroom experience. Playing the role of attorneys and witnesses, learners ask questions and challenge assumptions by playing roles in a trial with…

  1. The S-Star Trial Bioinformatics Course: An On-line Learning Success

    Science.gov (United States)

    Lim, Yun Ping; Hoog, Jan-Olov; Gardner, Phyllis; Ranganathan, Shoba; Andersson, Siv; Subbiah, Subramanian; Tan, Tin Wee; Hide, Winston; Weiss, Anthony S.

    2003-01-01

    The S-Star Trial Bioinformatics on-line course (www.s-star.org) is a global experiment in bioinformatics distance education. Six universities from five continents have participated in this project. One hundred and fifty students participated in the first trial course of which 96 followed through the entire course and 70 fulfilled the overall…

  2. Acupuncture as pain relief during delivery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten;

    2009-01-01

    with respect to pain intensity, birth experience, and obstetric outcome. METHODS: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...

  3. Franklin, Lavoisier, and Mesmer: origin of the controlled clinical trial.

    Science.gov (United States)

    Herr, Harry W

    2005-01-01

    In 1784, a Royal Commission headed by Benjamin Franklin and Antoine Lavoisier designed a series of ingenious experiments to debunk France's greatest medical rogue, Anton Mesmer, and his bizarre healing of illnesses based on his bogus theory of animal magnetism. Using intentional subject ignorance and sham interventions to investigate mesmerism, Franklin's commission provided a model for the controlled clinical trial.

  4. Organisation of a clinical trial unit--a proposal

    DEFF Research Database (Denmark)

    Gluud, C; Sørensen, T I

    1998-01-01

    , 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...

  5. Challenges in coding adverse events in clinical trials

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Maund, Emma; Gøtzsche, Peter C

    2012-01-01

    Misclassification of adverse events in clinical trials can sometimes have serious consequences. Therefore, each of the many steps involved, from a patient's adverse experience to presentation in tables in publications, should be as standardised as possible, minimising the scope for interpretation...

  6. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... for more information Scientists usually do years of experiments in the laboratory and in animals before they even consider testing an experimental treatment in people. Most of this early research occurs at universities and medical centers across the ...

  7. 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...

  8. Adubação da batata-doce em São Paulo parte: III - Métodos de aplicação de NPK e estêrco Fertilizer experiments with sweet potatoes: III - Trials on the placement of npk and manure

    Directory of Open Access Journals (Sweden)

    A. Paes de Camargo

    1962-01-01

    Full Text Available Neste artigo são relatadas nove experiências sôbre a localização de adubos na cultura de batata-doce, realizadas entre 1943-44 e 1946-47, sendo quatro com NPK (60-100-40 kg/ha de N-P2O5-K2O e cinco com estêrco. Em dois dos ensaios com NPK, conduzidos em Tupi Paulista (um dêles repetido por três anos no mesmo local, a adubação foi mais eficiente quando misturada com a terra dos camalhões do que aplicada sob eles ou em sulcos feitos em seus cumes. Nos outros dois, realizados em Campinas, a aplicação sob os camalhões se mostrou melhor, em média, mas os resultados variaram muito. Tratando-se de assunto que depende de muitos fatôres, inclusive das condições meteorológicas, os autores encarecem a necessidade de se continuarem as experiências, e, tendo discutido as vantagens e desvantagens dos métodos estudados, sugerem a inclusão, em futuros planos, do aplicação de P e K em sulcos laterais às mudas e de N em cobertura. Nas cinco experiências com estêrco, tôdas anuais e executadas em três localidades, seu espalhamento entre os camalhões se mostrou, em regra, inferior à aplicação sob os camalhões ou de mistura com o solo dêstes. Dos dois últimos métodos, o primeiro foi superior em três ensaios, igual em um e inferior no outro. As observações feitas indicam que, em geral, o estêrco deve ser colocado sob os camalhões.This paper reports the results of nine experiments conducted in the State of Sao Paulo on methods of application of NPK and manure for sweet potatoes (Ipomoea batatas Lam.. In two of the four trails with NPK, better results were obtained where it was broadcast before ridging than where it was placed in o furrow either under or on the top of the ridges. In the other two, the placement under the ridges showed better in the average, but the yearly results varied considerably. As the suitability of different methods of application depends on many factors, especially on the weather, the authors point to

  9. Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial.

    OpenAIRE

    Thomson, NC; Rubin, AS; Niven, RM; Corris, PA; Siersted, HC; Olivenstein, R.; Pavord, ID; McCormack, D.; Laviolette, M.; Shargill, NS; Cox, G.

    2011-01-01

    BACKGROUND: Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. METHODS: Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. Following initial...

  10. Long term (5 Year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial

    OpenAIRE

    Thomson, N C; Rubin, A.S.; Niven, R. M.; Corris, P A; Siersted, H. C.; Olivenstein, R.; Pavord, I.D.; McCormick, D.; Laviolette, M.; Shargill, N.S.; Cox, G.

    2011-01-01

    Background: Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. Methods: Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. ...

  11. The ALCHEMIST Lung Cancer Trial

    Science.gov (United States)

    A collection of material about the ALCHEMIST lung cancer trial that will examine tumor tissue from patients with early-stage, completely resected lung cancer for gene mutations in the EGFR and ALK genes, and a

  12. Quality assurance in clinical trials.

    NARCIS (Netherlands)

    Ottevanger, P.B.; Therasse, P.; Veld, C.J.H. van de; Bernier, J.; Krieken, J.H.J.M. van; Grol, R.P.T.M.; Mulder, P.H.M. de

    2003-01-01

    From the literature that was initially searched by electronic databases using the keywords quality, quality control and quality assurance in combination with clinical trials, surgery, pathology, radiotherapy, chemotherapy and data management, a comprehensive review is given on what quality assurance

  13. National Lung Screening Trial (NLST)

    Science.gov (United States)

    The National Lung Screening Trial (NLST), a research study sponsored by the National Cancer Institute that used low-dose helical CT scans or chest X-ray to screen men and women at risk for lung cancer.

  14. 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...

  15. ATLAS Canada lightpath data transfer trial

    CERN Document Server

    Kost, C J; Caron, B; Hong, W

    2003-01-01

    Emerging grids play a significant role in the computational, data, storage, and network requirements of high energy physics experiments coming online in the next few years. One such requirement, the bulk transfer of data over advanced high speed optical networks is necessary as such experiments are highly distributed with resources and participants from research laboratories and institutions spanning the globe. This trial at the iGrid 2002 conference attempts to stress the feasibility of high speed bulk data transfer over an end-to-end lightpath, a dedicated point-to-point optical link. Specifically, the objective was to transfer 1 TB of Monte Carlo data from TRIUMF in Vancouver, Canada, to CERN in Geneva, Switzerland. A rate equivalent to transferring a full CD of data every 8 s was achieved. (15 refs).

  16. Unfulfilled translation opportunities in industry sponsored clinical trials.

    Science.gov (United States)

    Smed, Marie; Getz, Kenneth A

    2013-05-01

    Knowledge generated by site representatives through their participation in clinical trials is valuable for testing new products in use and obtaining final market approval. The leverage of this important knowledge is however challenged as the former direct relationships between in-house staff in the industry and site representatives are changing. The process of clinical trials has increased in complexity over the years, resulting in additional management layers. Besides an increase in internal management layers, sponsors often also outsource various tasks related to clinical trials to a CRO (Contract Research Organization) and thereby adding another link in the relationships between site and sponsor. These changes are intended to optimize the time-consuming and costly trial phases; however, there is a need to study whether valuable knowledge and experience is compromised in the process. Limited research exists on the full range of clinical practice insights obtained by investigators during and after clinical trials and how well these insights are transferred to study sponsors. This study explores the important knowledge-transfer processes between sites and sponsors and to what extent sites' knowledge gained in clinical trials is utilized by the industry. Responses from 451 global investigative site representatives are included in the study. The analysis of the extensive dataset reveals that the current processes of collaboration between sites and the industry restrict the leverage of valuable knowledge gained by physicians in the process of clinical trials. These restrictions to knowledge-transfer between site and sponsor are further challenged if CRO partners are integrated in the trial process. PMID:23454567

  17. 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

  18. Collaborative trial on groundwater sampling

    OpenAIRE

    Ghestem, Jean Philippe; Fisicaro, Paula; Champion, Rachel

    2011-01-01

    The trial presented here was conducted by BRGM in collaboration with LNE under the work program AQUAREF 2009 with the support of ONEMA. This is a collaborative trial on groundwater sampling and on field physico chemical measurement. It is not a proficiency test. He had three goals: * Observe and evaluate the practices of groundwater sampling to improve future guides, standards and specifications. * Assess the impact of sampling on variability of results. * Study the accuracy of field measurem...

  19. The impact of trial runs on the acceptability of pigouvian taxes: experimental evidence

    Energy Technology Data Exchange (ETDEWEB)

    Cherry, Todd L.; Kallbekken, Steffen; Kroll, Stephen

    2011-07-01

    This paper examines the political difficulty of enacting welfare-enhancing Pigouvian taxes. Using referenda in a market experiment with externalities, we investigate the effect of trial periods on the acceptability of two theoretically equivalent variants of Pigouvian taxes. While implementing either tax is in subjects material self-interest, we find significant levels of opposition to both tax schemes, though the level differs considerably. Results show that trial runs can overcome initial tax aversion, significantly increasing acceptability. The effect is robust across tax schemes, but a trial with one scheme does not affect the acceptability of the other. Trial periods also mitigate initial biases in preferences of alternative tax schemes. (auth)

  20. Categorization of field trials with GM plants in the Netherlands: applicable to field trials with GM forest trees?

    Directory of Open Access Journals (Sweden)

    Glandorf DCM

    2015-04-01

    Full Text Available In the Netherlands, criteria have been set for field trials with genetically modified (GM plants. These criteria are based on the step-by-step principle as described in European Directive 2001/18/EC. Three categories of field trials are defined. The first category concerns small-scale field trials with GM plants that are not well characterised on the molecular and phenotypic level. Confinement measures are applied in order to limit potential adverse effects to the field location. The second category consists of small-scale field experiments with GM plants that are better characterized. Confinement measures are no longer necessary since sufficient information is available to assess potential adverse effects on human health and the environment for these trials. The third category consists of large-scale field trials with fully characterised GM plants and without the need of confinement measures. For each category, a new permit is required. This system has been used for several crops, including apple and poplar trees and may also be applicable for trials with GM forest trees.

  1. Building clinical trial capacity to develop a new treatment for multidrug-resistant tuberculosis

    Science.gov (United States)

    Tupasi, Thelma; Danilovits, Manfred; Cirule, Andra; Sanchez-Garavito, Epifanio; Xiao, Heping; Cabrera-Rivero, Jose L; Vargas-Vasquez, Dante E; Gao, Mengqiu; Awad, Mohamed; Gentry, Leesa M; Geiter, Lawrence J; Wells, Charles D

    2016-01-01

    Abstract Problem New drugs for infectious diseases often need to be evaluated in low-resource settings. While people working in such settings often provide high-quality care and perform operational research activities, they generally have less experience in conducting clinical trials designed for drug approval by stringent regulatory authorities. Approach We carried out a capacity-building programme during a multi-centre randomized controlled trial of delamanid, a new drug for the treatment of multidrug-resistant tuberculosis. The programme included: (i) site identification and needs assessment; (ii) achieving International Conference on Harmonization – Good Clinical Practice (ICH-GCP) standards; (iii) establishing trial management; and (iv) increasing knowledge of global and local regulatory issues. Local setting Trials were conducted at 17 sites in nine countries (China, Egypt, Estonia, Japan, Latvia, Peru, the Philippines, the Republic of Korea and the United States of America). Eight of the 10 sites in low-resource settings had no experience in conducting the requisite clinical trials. Relevant changes Extensive capacity-building was done in all 10 sites. The programme resulted in improved local capacity in key areas such as trial design, data safety and monitoring, trial conduct and laboratory services. Lessons learnt Clinical trials designed to generate data for regulatory approval require additional efforts beyond traditional research-capacity strengthening. Such capacity-building approaches provide an opportunity for product development partnerships to improve health systems beyond the direct conduct of the specific trial. PMID:26908964

  2. Challenges and guidelines for clinical trial of herbal drugs

    Directory of Open Access Journals (Sweden)

    Abida Parveen

    2015-01-01

    Full Text Available World Health Organization (WHO has defined herbal medicines as finished labeled medicinal product that contain an active ingredient, aerial, or underground parts of the plant or other plant material or combinations. According to a report of WHO, about 80% of the world population is reported to rely on traditional medicine for their primary health care needs. Even in the developed countries, complementary or alternative medicine is gaining popularity. A report of a global survey on national policy on traditional medicine and regulation of herbal medicines indicated that about 50 countries including China, Japan, and Germany already have their national policy and laws on regulations of traditional medicines. Herbal drugs possess a long history of its use and better patient tolerance. These are cheaper and easily available in countries like India due to rich agro culture conditions. However, reckless utilization of resources threatens the sustainability of several plant species. Traditional medicines are governed by the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945. In 1959, the Government of India amended the Drugs and Cosmetics Act to include drugs that are derived from traditional Indian medicine. In 1993, the guidelines for the safety and efficacy of herbal medicines developed by an expert committee directed that the procedures laid down by the office of the Drug Controller General of India for allopathic drugs should be followed for all traditional and herbal products to enter into clinical trials for any therapeutic condition. However, there are certain loop holes in the clinical trials of herbal drugs as the lack of stringent bylaws and regulations. Hence, a deep insight of important challenges and major regulatory guidelines for clinical trial of herbal drugs and botanicals is discussed in the present communication. There is lack of scientific evidence to evaluate safety and efficacy of herbal drugs. The quality

  3. 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...

  4. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram;

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were...

  5. Ethical pitfalls in neonatal comparative effectiveness trials.

    Science.gov (United States)

    Modi, Neena

    2014-01-01

    oxygen that are too low or too high. Investigators in the UK, Australia, New Zealand and the USA designed randomized controlled trials to provide more precise guidance, by determining whether targeting the lower end of the accepted range (85-89%) resulted in reduced retinopathy of prematurity when compared with the upper end of the accepted range (91-95%). Between 2004 and 2009, the US SUPPORT trial (Surfactant, Positive Pressure and Oxygenation Randomized Trial) recruited approximately 1,300 infants and showed that babies at the higher end of the recommended oxygen saturation range had a greater incidence of retinopathy of prematurity, but that, unexpectedly, babies at the lower end had a higher risk of death [1]. The data monitoring committees of the BOOST II (Oxygen Saturation and Outcomes in Preterm Infants) trials in the UK, Australia and New Zealand reviewed their interim data, confirmed the higher risk of death in babies randomized to the lower saturation range, and halted further recruitment [2]. Without the trials, the lower saturation target would have continued to be applied to many babies, and many would have died as a result. Though many uncertainties remain, the trials facilitated advances in care. However, in March 2013, the lead investigators for the SUPPORT trial were informed by the US 'Office for Human Research Protections' that they were 'in violation of the regulatory requirements for informed consent, stemming from the failure to describe the reasonably foreseeable risks of blindness, neurological damage and death' [3]. This extraordinary conclusion indicates that the US regulators considered the researchers to be at fault for failing to foresee an unexpected trial result, and for randomizing babies to receive oxygen within the accepted standard-of-care limits. The ruling further implies that the regulators consider that clinicians are acting ethically when they deliver an accepted but non-evidence-based treatment based upon their personal bias, but

  6. The feasibility of a home-based sedentary behaviour intervention for hospitalised chronic obstructive pulmonary disease (COPD patients: Sitting and ExacerbAtions Trial (COPD-SEAT

    Directory of Open Access Journals (Sweden)

    Mark Orme

    2015-10-01

    COPD-SEAT will be one of the first trials aimed at reducing sedentary behaviour at home in patients hospitalised for an acute exacerbation of COPD. This trial will provide valuable insight into the feasibility of implementing an at-home technology-based feedback intervention for reducing sedentary behaviour into patients existing care. Findings will inform a future large-scale trial acting as an adjuvant to pulmonary rehabilitation.

  7. Another Look at Vividness in the Trial of Two Vietnamese Brothers.

    Science.gov (United States)

    Bresnahan, Mary I.

    A study examined the trial of People v. Tien (two Vietnamese brothers named defendants in an assault case). In order to understand better the relationship between supportive speech acts and credibility, the study examined how the attorney elicited vivid testimony. One of the ways in which an attorney yields control of testimony to a witness is by…

  8. 77 FR 40322 - Oral Rabies Vaccine Trial; Availability of an Environmental Assessment

    Science.gov (United States)

    2012-07-09

    ... the U.S. Department of Agriculture Forest Service National Forest System lands, excluding Wilderness... National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of... Service has prepared an environmental assessment relative to an oral rabies vaccination field trial in...

  9. Usability testing of wireless broadband LAN in the MEDIAN user trials

    NARCIS (Netherlands)

    Dam, C. van; Vliet, P.J. van; Schuurman, K.; Maltha, S.R.; Leyten, A.J.M.; Dirks, M.W.S.

    1999-01-01

    The main objective of the ACTS MEDIAN project is to build a high speed WCPN/LAN demonstrator system for multimedia applications and demonstrate it in user trials. The demonstrator system, consisting of one base station and two portable stations, is capable of handling high speed (up to 150 Mbit/s) A

  10. 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

  11. 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.

  12. Gene Therapy in Cardiac Surgery: Clinical Trials, Challenges, and Perspectives.

    Science.gov (United States)

    Katz, Michael G; Fargnoli, Anthony S; Kendle, Andrew P; Hajjar, Roger J; Bridges, Charles R

    2016-06-01

    The concept of gene therapy was introduced in the 1970s after the development of recombinant DNA technology. Despite the initial great expectations, this field experienced early setbacks. Recent years have seen a revival of clinical programs of gene therapy in different fields of medicine. There are many promising targets for genetic therapy as an adjunct to cardiac surgery. The first positive long-term results were published for adenoviral administration of vascular endothelial growth factor with coronary artery bypass grafting. In this review we analyze the past, present, and future of gene therapy in cardiac surgery. The articles discussed were collected through PubMed and from author experience. The clinical trials referenced were found through the Wiley clinical trial database (http://www.wiley.com/legacy/wileychi/genmed/clinical/) as well as the National Institutes of Health clinical trial database (Clinicaltrials.gov). PMID:26801060

  13. Building Successful Relationships in the PLCO Cancer Screening Trial.

    Science.gov (United States)

    Marcus, Pamela M; Broski, Karen G; Buys, Saundra S; Childs, Jeffery; Church, Timothy R; Gohagan, John K; Gren, Lisa H; Higgins, Darlene; Jaggi, Rachel; Jenkins, Victoria; Johnson, Christine C; Lappe, Karen; O'Brien, Barbara; Ogden, Sheryl L; Prorok, Philip C; Reding, Douglas; Shambaugh, Vicki; Yokochi, Lance A; Yurgalevitch, Susan

    2015-01-01

    Biomedical research cannot succeed without funding, knowledgeable staff, and appropriate infrastructure. There are however equally important but intangible factors that are rarely considered in planning large multidisciplinary endeavors or evaluating their success. The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial required extensive collaborations between individuals from many fields, including clinicians, clinical trialists, and administrators; it also addressed questions across the spectrum of cancer prevention and control. In this manuscript, we examine the experiences and opinions of trial staff regarding the building of successful relationships in PLCO. We summarize, in narrative form, data collected using open-ended questionnaires that were administered to the National Cancer Institute project officers, coordinating center staff, screening center principal investigators, and screening center coordinators in 2015, about 3 years after publication of the final primary trial manuscript. Trust, respect, listening to others, and in-person interaction were frequently mentioned as crucial to building successful relationships.

  14. A walking programme and a supervised exercise class versus usual physiotherapy for chronic low back pain: a single-blinded randomised controlled trial. (The Supervised Walking In comparison to Fitness Training for Back Pain (SWIFT) Trial).

    LENUS (Irish Health Repository)

    Hurley, Deirdre A

    2009-01-01

    BACKGROUND: Chronic low back pain (CLBP) is a persistent disabling condition with rising significant healthcare, social and economic costs. Current research supports the use of exercise-based treatment approaches that encourage people with CLBP to assume a physically active role in their recovery. While international clinical guidelines and systematic reviews for CLBP support supervised group exercise as an attractive first-line option for treating large numbers of CLBP patients at low cost, barriers to their delivery include space and time restrictions in healthcare settings and poor patient attendance. The European Clinical Guidelines have identified the need for research in the use of brief\\/minimal contact self-activation interventions that encourage participation in physical activity for CLBP. Walking may be an ideally suited form of individualized exercise prescription as it is easy to do, requires no special skills or facilities, and is achievable by virtually all ages with little risk of injury, but its effectiveness for LBP is unproven. METHODS AND DESIGN: This study will be an assessor-blinded randomized controlled trial that will investigate the difference in clinical effectiveness and costs of an individualized walking programme and a supervised general exercise programme compared to usual physiotherapy, which will act as the control group, in people with chronic low back pain. A sample of 246 patients will be recruited in Dublin, Ireland through acute general hospital outpatient physiotherapy departments that provide treatment for people with CLBP. Patients will be randomly allocated to one of the three groups in a concealed manner. The main outcomes will be functional disability, pain, quality of life, fear avoidance, back beliefs, physical activity, satisfaction and costs, which will be evaluated at baseline, and 3, 6 and 12 months [follow-up by pre-paid postage]. Qualitative telephone interviews and focus groups will be embedded in the research

  15. A walking programme and a supervised exercise class versus usual physiotherapy for chronic low back pain: a single-blinded randomised controlled trial. (The Supervised Walking In comparison to Fitness Training for Back Pain (SWIFT Trial

    Directory of Open Access Journals (Sweden)

    Daly Leslie

    2009-07-01

    Full Text Available Abstract Background Chronic low back pain (CLBP is a persistent disabling condition with rising significant healthcare, social and economic costs. Current research supports the use of exercise-based treatment approaches that encourage people with CLBP to assume a physically active role in their recovery. While international clinical guidelines and systematic reviews for CLBP support supervised group exercise as an attractive first-line option for treating large numbers of CLBP patients at low cost, barriers to their delivery include space and time restrictions in healthcare settings and poor patient attendance. The European Clinical Guidelines have identified the need for research in the use of brief/minimal contact self-activation interventions that encourage participation in physical activity for CLBP. Walking may be an ideally suited form of individualized exercise prescription as it is easy to do, requires no special skills or facilities, and is achievable by virtually all ages with little risk of injury, but its effectiveness for LBP is unproven. Methods and design This study will be an assessor-blinded randomized controlled trial that will investigate the difference in clinical effectiveness and costs of an individualized walking programme and a supervised general exercise programme compared to usual physiotherapy, which will act as the control group, in people with chronic low back pain. A sample of 246 patients will be recruited in Dublin, Ireland through acute general hospital outpatient physiotherapy departments that provide treatment for people with CLBP. Patients will be randomly allocated to one of the three groups in a concealed manner. The main outcomes will be functional disability, pain, quality of life, fear avoidance, back beliefs, physical activity, satisfaction and costs, which will be evaluated at baseline, and 3, 6 and 12 months [follow-up by pre-paid postage]. Qualitative telephone interviews and focus groups will be

  16. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram;

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were......, in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...

  17. Removing samples taken illegally in the criminal trial

    OpenAIRE

    Ph. D. Dumitru Rădescu

    2009-01-01

    As far as evidence in a criminal trial is concerned, Criminal Act no. 281/2003 has brought about a new procedural sanction in Romanian criminal procedure, completing article 64 in the Code of Criminal Procedure by a second para-graph, namely the exclusionary rule. The case-law of the European Court in Strasbourg is not very clear when it comes to the admissibility of illegally seized evidence against the defendant. As opposed to that, American and British common law and, following these stand...

  18. Modification as a propositional act

    DEFF Research Database (Denmark)

    Rijkhoff, Jan

    2014-01-01

    material in a Discourse Act has been largely ignored. This chapter argues (i) that modifying is no less actional than predicating or referring in the process of verbal communication and (ii) that the modifying function of linguistic material should be specified at the highest level of representation...

  19. 76 FR 59073 - Privacy Act

    Science.gov (United States)

    2011-09-23

    ...) and (p) to read as follows: Sec. 1901.02 Definitions. * * * * * (o) Director of Central Intelligence... From the Federal Register Online via the Government Publishing Office CENTRAL INTELLIGENCE AGENCY 32 CFR Part 1901 Privacy Act AGENCY: Central Intelligence Agency. ACTION: Proposed rule....

  20. 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.

  1. The Ontogenesis of Speech Acts

    Science.gov (United States)

    Bruner, Jerome S.

    1975-01-01

    A speech act approach to the transition from pre-linguistic to linguistic communication is adopted in order to consider language in relation to behavior and to allow for an emphasis on the use, rather than the form, of language. A pilot study of mothers and infants is discussed. (Author/RM)

  2. Dumping at Sea Act 1974

    International Nuclear Information System (INIS)

    This Act enables the United Kingdom Government to ratify both the Oslo Convention of 1972 for the Prevention of Marine Pollution by Dumping from Ships and Aircraft and the London Convention of 1972 on the Prevention of Marine Pollution by Dumping of Wastes and Other Matter. (NEA)

  3. Personal Information as Communicative Acts

    DEFF Research Database (Denmark)

    Mai, Jens-Erik

    2016-01-01

    as communicative acts. The paper suggests a reconceptualization of informational privacy from having its focus on controlling, limiting, and restricting access to material carriers of information to a focus on a regulation of the use, analysis, and interpretation of personal information....

  4. 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

  5. 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...

  6. Against acts of nuclear terrorism

    International Nuclear Information System (INIS)

    The Act on the International Convention of the United Nations of April 13, 2005 on Combating Acts of Nuclear Terrorism was promulgated in the German Federal Gazette and entered into force one day later. The Convention expresses the deep concern about the worldwide escalation of all kinds and manifestations of acts of terrorism. What was true in April 2005 (the year the UN convention was adopted) is even more true today. At the same time, however, the Convention recognizes the right of all nations to develop and use nuclear power for peaceful purposes, acknowledging their justified interest in the possible benefits of the peaceful uses of nuclear power. As the Convention was signed in German still during the term of office of the Red-Green government, this passage is a remarkable acceptance of the realities of the world and past peaceful uses of nuclear power in Germany. Whether or not the convention will become an effective instrument to be used against acts of nuclear terrorism and threats depends on its entering into force after deposition of 22 ratification documents, and on as many states as possible acceding to it. Irrespective of these aspects, action in the spirit of the Convention should be taken now, criminal law should be adapted, and international cooperation should be improved and strengthened. (orig.)

  7. Developing a survey of barriers and facilitators to recruitment in randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Kaur Geetinder

    2012-11-01

    Full Text Available Abstract Background Recruitment to randomized controlled trials is known to be challenging. It is important to understand and identify predictors of good or poor accrual to a clinical trial so that appropriate strategies can be put in place to overcome these problems and facilitate successful trial completion. We have developed a survey tool to establish the recruitment experience of clinical teams regarding facilitators and barriers to recruitment in a clinical trial and describe herein the method of developing the questionnaire. Methods A literature search was conducted to identify studies that have explored facilitators and barriers to recruitment, and a list of potential factors affecting recruitment to a clinical trial was generated. These factors were categorized in terms relating to the (i trial, (ii site, (iii patient, (iv clinical team, (v information and consent and (vi study team. A list was provided for responders to grade these factors as weak, intermediate or strong facilitators or barriers to recruitment. Results A web-based survey questionnaire was developed. This survey was designed to establish the recruitment experience of clinical teams with regard to the perceived facilitators and barriers to recruitment, to identify strategies applied to overcome these problems, and to obtain suggestions for change in the organization of future trials. The survey tool can be used to assess the recruitment experience of clinical teams in a single/multicenter trial in any clinical setting or speciality involving adults or children either in an ongoing trial or at trial completion. The questionnaire is short, easy to administer and to complete, with an estimated completion time of 11 minutes. Conclusions We have presented a robust methodology for developing this survey tool that provides an evidence-based list of potential factors that can affect recruitment to a clinical trial. We recommend that all clinical trialists should consider using

  8. The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials.

    Science.gov (United States)

    van Staa, Tjeerd-Pieter; Dyson, Lisa; McCann, Gerard; Padmanabhan, Shivani; Belatri, Rabah; Goldacre, Ben; Cassell, Jackie; Pirmohamed, Munir; Torgerson, David; Ronaldson, Sarah; Adamson, Joy; Taweel, Adel; Delaney, Brendan; Mahmood, Samhar; Baracaia, Simona; Round, Thomas; Fox, Robin; Hunter, Tommy; Gulliford, Martin; Smeeth, Liam

    2014-01-01

    BACKGROUND Pragmatic trials compare the effects of different decisions in usual clinical practice. OBJECTIVES To develop and evaluate methods to implement simple pragmatic trials using routinely collected electronic health records (EHRs) and recruiting patients at the point of care; to identify the barriers and facilitators for general practitioners (GPs) and patients and the experiences of trial participants. DESIGN Two exemplar randomised trials (Retropro and eLung) with qualitative evaluations. SETTING Four hundred and fifty-nine English and Scottish general practices contributing EHRs to a research database, of which 17 participated in the trials. PARTICIPANTS Retropro aimed to recruit 300 patients with hypercholesterolaemia and high cardiovascular risk and eLung aimed to recruit 150 patients with a chronic obstructive pulmonary disease exacerbation. INTERVENTIONS Retropro randomised between simvastatin and atorvastatin and eLung between immediate antibiotics and deferred or non-use. eLung recruited during an unscheduled consultation using EHR flagging. MAIN OUTCOME MEASURE Successful trial completion with implementation of information technology (IT) system for flagging and data processing and documentation of operational and scientific experiences. DATA SOURCES EHR research database. RESULTS The governance approval process took over 3 years. A total of 58.8% of the practices (n = 270) expressed interest in participating. The number of interested practices dropped substantially with each stage of the governance process. In Retropro, 6.5% of the practices (n = 30) were eventually approved and 3.7% (n = 17) recruited patients; in eLung, these numbers were 6.8% (n = 31) and 1.3% (n = 6) respectively. Retropro successfully completed recruitment (301 patients) whereas eLung recruited 31 patients. Retropro recruited 20.6% of all statin starters in recruiting practices and 1.1% in the EHR database; the comparable numbers for eLung were 32.3% and 0

  9. Future trials of endovascular mechanical recanalisation therapy in acute ischemic stroke patients - A position paper endorsed by ESMINT and ESNR. Pt. 2. Methodology of future trials

    Energy Technology Data Exchange (ETDEWEB)

    Fiehler, Jens [University Medical Centre Hamburg-Eppendorf, Department of Neuroradiology, Hamburg (Germany); Soederman, Michael [Karolinska University Hospital, Department of Neuroradiology, Stockholm (Sweden); Turjman, Francis [Hopital neurologique, Centre de Neurosciences Cognitives, Department of Neuroradiology, Lyon (France); White, Philip M. [University of Edinburgh, Department of Clinical Neurosciences, Western General Hospital, Edinburgh (United Kingdom); Bakke, Soeren Jacob [Oslo University Hospital, Department of Neuroradiology, Oslo (Norway); Mangiafico, Salvatore [University Hospital Careggi, Interventional Neuroradiology Unit, Florence (Italy); Kummer, Ruediger von [University of Dresden, Department of Neuroradiology, Dresden (Germany); Muto, Mario [University of Naples, Department of Neuroradiology, Naples (Italy); Cognard, Christophe [Hopital Purpan, Service de Neuroradiologie, Toulouse (France); Gralla, Jan [Inselspital Bern, Department of Neuroradiology, Bern (Switzerland)

    2012-12-15

    Based on current data and experience, the joint working group of the European Society of Minimally Invasive Neurological Therapy (ESMINT) and the European Society of Neuroradiology (ESNR) make suggestions on trial design and conduct aimed to investigate therapeutic effects of mechanical thrombectomy (MT). We anticipate that this roadmap will facilitate the setting up and conduct of successful trials in close collaboration with our neighbouring disciplines. (orig.)

  10. Supportive care for men with prostate cancer:why are the trials not working? A systematic review and recommendations for future trials

    OpenAIRE

    Moore, Theresa H M; King, Anna J L; Evans, Maggie A; Sharp, Debbie J; Persad, Rajendra A; Huntley, Alyson L.

    2015-01-01

    Men with prostate cancer are likely to have a long illness and experience psychological distress for which supportive care may be helpful. This systematic review describes the evidence for effectiveness and cost-effectiveness of supportive care for men with prostate cancer, taking into account treatment pathway and components of interventions. MEDLINE, EMBASE, CINAHL, CENTRAL, and Psychinfo were searched from inception––July 2013 for randomized controlled trials and controlled trials. Two aut...

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

    Science.gov (United States)

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

    2016-05-01

    Composite endpoints are commonly used as the primary measure of efficacy in heart failure clinical trials to assess the overall treatment effect and to increase the efficiency of trials. Clinical trials still must enrol large numbers of patients to accrue a sufficient number of outcome events and have adequate power to draw conclusions about the efficacy and safety of new treatments for heart failure. Additionally, the societal and health system perspectives on heart failure have raised interest in ascertaining the effects of therapy on outcomes such as repeat hospitalization and the patient's burden of disease. Thus, novel methods for using composite endpoints in clinical trials (e.g. clinical status composite endpoints, recurrent event analyses) are being applied in current and planned trials. Endpoints that measure functional status or reflect the patient experience are important but used cautiously because heart failure treatments may improve function yet have adverse effects on mortality. This paper discusses the use of traditional and new composite endpoints, identifies qualities of robust composites, and outlines opportunities for future research. PMID:27071916

  12. Making birthing safe for Pakistan women: a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Khan Muhammad

    2012-07-01

    Full Text Available Abstract Background Two out of three neonatal deaths occur in just 10 countries and Pakistan stands third among them. Maternal mortality is also high with most deaths occurring during labor, birth, and first few hours after birth. Enhanced access and utilization of skilled delivery and emergency obstetric care is the demonstrated strategy in reducing maternal and neonatal mortality. This trial aims to compare reduction in neonate mortality and utilization of available safe birthing and Emergency Obstetric and Neonatal Care services among pregnant mothers receiving ‘structured birth planning’, and/or ‘transport facilitation’ compared to routine care. Methods A pragmatic cluster randomized trial, with qualitative and economic studies, will be conducted in Jhang, Chiniot and Khanewal districts of Punjab, Pakistan, from February 2011 to May 2013. At least 29,295 pregnancies will be registered in the three arms, seven clusters per arm; 1 structured birth planning and travel facilitation, 2 structured birth planning, and 3 control arm. Trial will be conducted through the Lady Health Worker program. Main outcomes are difference in neonatal mortality and service utilization; maternal mortality being the secondary outcome. Cluster level analysis will be done according to intention-to-treat. Discussion A nationwide network of about 100,000 lady health workers is already involved in antenatal and postnatal care of pregnant women. They also act as “gatekeepers” for the child birthing services. This gate keeping role mainly includes counseling and referral for skill birth attendance and travel arrangements for emergency obstetric care (if required. The review of current arrangements and practices show that the care delivery process needs enhancement to include adequate information provision as well as informed “decision” making and planned “action” by the pregnant women. The proposed three-year research is to develop, through national

  13. Genetic pesticides: Monsanto goes ahead with trials.

    Science.gov (United States)

    Beardsley, Tim

    The Monsanto Company will soon notify the Environmental Protection Agency (EPA) that it plans to conduct the first field test of a genetically-engineered microbial pesticide, thereby becoming the first company to break with the convention whereby private corporations have voluntarily sought approval for genetic engineering experiments from the Recombinant DNA Advisory Committee (RAC) of the National Institutes of Health (NIH). It is assumed that Monsanto's decision was influenced by a preliminary legal injunction blocking NIH approval of such field trials without a formal environmental assessment. EPA will allow tests, after 90 days' notice, if it raises no objections to the protocol. Although EPA will not formally call on RAC to examine the protocol, an agency spokesperson said there is "total agreement" between EPA and RAC on what data must be included.

  14. Mismatch Negativity Affects Muscle Fatigue during Repeated Contraction Trials of Different Durations

    Science.gov (United States)

    Aleksandrov, Aleksander A.; Knyazeva, Veronika M.; Stankevich, Ludmila N.; Dmitrieva, Elena S.; Shestakova, Anna N.

    2016-01-01

    We examined the effect of involuntary attention switching (related to mismatch negativity generation in the oddball paradigm) on fatigue development during trials of different durations. The experiment consisted of two trials, long (40 min) and short (15 min), and two experimental conditions in each trial: the simple reaction task (deviants-only paradigm) and the stimuli recognition task (oddball paradigm). In each condition, a participant responded to each target acoustic stimulus by squeezing a handgrip dynamometer. We found the significantly lower rates of fatigue development in the short-trial deviants-only paradigm compared to the long trial. The short- and the long-trial oddball paradigms differed significantly from both the short- and the long-trial deviants-only paradigms. The results demonstrated that the fatigue developed differently depending on the expected trial duration. The involuntary activation of attention broke this subconscious regulative mechanism leading to increase of the compression force during the long trial and its decrease during the short. PMID:26869932

  15. Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials.

    Science.gov (United States)

    Smalley, Jaye Bea; Merritt, Maria W; Al-Khatib, Sana M; McCall, Debbe; Staman, Karen L; Stepnowsky, Carl

    2015-10-01

    Pragmatic clinical trials are designed to inform decision makers about the benefits, burdens, and risks of health interventions in real-world settings. Pragmatic clinical trials often use for research purposes data collected in the course of clinical practice. The distinctive features of pragmatic clinical trials demand fresh thinking about what is required to act properly toward people affected by their conduct, in ways that go beyond ensuring the protection of rights and welfare for "human research subjects" under conventional research ethics regulations. To stimulate such work, we propose to distinguish among categories of research participants in pragmatic clinical trials as follows: Direct participants: (1) individuals being directly intervened upon and/or (2) individuals from whom personal identifiable data are being collected for the purposes of the pragmatic clinical trial. Indirect participants: individuals who are (1) not identified as direct participants and (2) whose rights and welfare may be affected by the intervention through their routine exposure to the environment in which the intervention is being deployed. Collateral participants: patient groups and other stakeholder communities who may be otherwise affected by the occurrence and findings of the pragmatic clinical trial. We illustrate these distinctions with case examples and discuss the distinctive responsibilities of researchers and pragmatic clinical trial leadership toward each type of participant. We suggest that pragmatic clinical trial investigators, institutional review boards, health systems leaders, and others engaged in the research enterprise work together to identify these participants. For indirect participants, risks and benefits to which they are exposed should be weighed to ensure that their rights and welfare are protected accordingly, and communication strategies should be considered to help them make well-informed decisions. Collateral participants could provide input on the

  16. Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials.

    Science.gov (United States)

    Smalley, Jaye Bea; Merritt, Maria W; Al-Khatib, Sana M; McCall, Debbe; Staman, Karen L; Stepnowsky, Carl

    2015-10-01

    Pragmatic clinical trials are designed to inform decision makers about the benefits, burdens, and risks of health interventions in real-world settings. Pragmatic clinical trials often use for research purposes data collected in the course of clinical practice. The distinctive features of pragmatic clinical trials demand fresh thinking about what is required to act properly toward people affected by their conduct, in ways that go beyond ensuring the protection of rights and welfare for "human research subjects" under conventional research ethics regulations. To stimulate such work, we propose to distinguish among categories of research participants in pragmatic clinical trials as follows: Direct participants: (1) individuals being directly intervened upon and/or (2) individuals from whom personal identifiable data are being collected for the purposes of the pragmatic clinical trial. Indirect participants: individuals who are (1) not identified as direct participants and (2) whose rights and welfare may be affected by the intervention through their routine exposure to the environment in which the intervention is being deployed. Collateral participants: patient groups and other stakeholder communities who may be otherwise affected by the occurrence and findings of the pragmatic clinical trial. We illustrate these distinctions with case examples and discuss the distinctive responsibilities of researchers and pragmatic clinical trial leadership toward each type of participant. We suggest that pragmatic clinical trial investigators, institutional review boards, health systems leaders, and others engaged in the research enterprise work together to identify these participants. For indirect participants, risks and benefits to which they are exposed should be weighed to ensure that their rights and welfare are protected accordingly, and communication strategies should be considered to help them make well-informed decisions. Collateral participants could provide input on the

  17. Trials with a Strain Gauge.

    Science.gov (United States)

    Auty, Geoff

    1996-01-01

    Describes an attempt to match the goals of the practical demonstration of the use of a strain gauge and the technical applications of science and responding to student questions in early trials, while keeping within the level of electronics in advanced physics. (Author/JRH)

  18. The Best Bypass Surgery Trial

    DEFF Research Database (Denmark)

    Møller, Christian H; Jensen, Birte Østergaard; Gluud, Christian;

    2007-01-01

    Recent trials suggest that off-pump coronary artery bypass grafting (OPCAB) reduces the risk of mortality and morbidity compared with conventional coronary artery bypass grafting (CCAB) using cardiopulmonary bypass. Patients with a moderate- to high-risk of complications after CCAB may have...

  19. Anthropologists in Global Health Experiments.

    Science.gov (United States)

    Hardon, Anita; Pool, Robert

    2016-01-01

    Can global health experiments be part of more flexible systems of knowledge generation, where different bodies of knowledge come together to provide understanding not only of the outcomes of new interventions but also of the mechanisms through which they affect people's well-being and health? Building past work in which they tried to transform how global health experiments are carried out and inspired by the articles in this special issue, the authors of this commentary argue that strategic collaboration is needed to break the hegemony of randomized controlled trials in designing global health technologies. More open-ended experiments are possible if anthropologists team up with innovative researchers in biomedicine to develop new conceptual models and to adopt novel observational techniques and 'smart' trials that incorporate ethnography to unravel complex interactions between local biologies, attributes of health systems, social infrastructures, and users' everyday lives. PMID:27618222

  20. Eficácia da auriculoterapia para estresse segundo experiência do terapeuta: ensaio clínico Eficacia de la auriculoterapia para estrés según experiencia del terapeuta: ensayo clínico Effectiveness of auriculotherapy for stress, based on experience of the therapist: a clinical trial

    Directory of Open Access Journals (Sweden)

    Leonice Fumiko Sato Kurebayashi

    2012-01-01

    resultado marginalmente significativo se encontro en el follow-up entre grupo 1/2 (p=0, 059. CONCLUSIÓN: La auriculoterapia con terapeutas más experientes redujo eficazmente el estrés en profesionales de Enfermería, entre tanto, se considera la necesidad de más estudios con este procedimiento.OBJECTIVE: To evaluate the efficacy of auriculotherapy with semipermanent needles on stress levels in the nursing staff of a teaching hospital. METHODS: A clinical trial with forty-nine people randomized into three groups: group 1 (control, group 2 (less experienced therapists and group 3 (more experienced therapists, conducted between January and July 2010. The subjects received eight sessions with the Shen Mein, kidney and brainstem points being assessed at baseline, after four and eight sessions, and at follow-up (15 days. RESULTS: The ANOVA showed statistically significant differences between the results before and after between the groups in the third assessment (F = 3.404 / p = 0.042 and at follow-up (F = 4.106 / p = 0.023. These differences were between groups 1/3 in the third assessment (p = 0.036 and at follow-up (p = 0.033. A marginally significant result was found at follow-up between groups 1/2 (p = 0 059. CONCLUSION: Auriculotherapy with more experienced therapists effectively reduced stress in nursing professionals, however, one considers the need for more studies with this procedure.

  1. 34 CFR 300.4 - Act.

    Science.gov (United States)

    2010-07-01

    ... 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 the Offices of the Department of Education (Continued) OFFICE OF SPECIAL EDUCATION AND REHABILITATIVE...

  2. 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...

  3. A centralised public information resource for randomised trials: a scoping study to explore desirability and feasibility

    Directory of Open Access Journals (Sweden)

    Entwistle Vikki A

    2005-05-01

    Full Text Available Abstract Background There are currently several concerns about the ways in which people are recruited to participate in randomised controlled trials, the low acceptance rates among people invited to participate, and the experiences of trial participants. An information resource about on-going clinical trials designed for potential and current participants could help overcome some of these problems. Methods We carried out a scoping exercise to explore the desirability and feasibility of establishing such a resource. We sought the views of a range of people including people who were considering taking part in a trial, current trial participants, people who had been asked but refused to participate in a trial, consumer group representatives and researchers who design and conduct trials. Results There was broad-based support for the concept of a centralised information resource for members of the public about on-going and recently completed clinical trials. Such an information resource could be based on a database containing standardised information for each trial relating to the purpose of the trial; the interventions being compared; the implications of participation for participants; and features indicative of scientific quality and ethical probity. The usefulness of the database could be enhanced if its search facility could allow people to enter criteria such as a disease and geographic area and be presented with all the trials relevant to them, and if optional display formats could allow them to view information in varying levels of detail. Access via the Internet was considered desirable, with complementary supported access via health information services. The development of such a resource is technically feasible, but the collation of the required information would take a significant investment of resources. Conclusion A centralised participant oriented information resource about clinical trials could serve several purposes. A more detailed

  4. Bronchodilator treatment of stable COPD: long-acting anticholinergics

    Directory of Open Access Journals (Sweden)

    W. Vincken

    2005-09-01

    Full Text Available Since airflow obstruction in chronic obstructive pulmonary disease (COPD is to some extent reversible, bronchodilators play an important role in the maintenance treatment of COPD the more they reduce hyperinflation and, as a result, improve dyspnoea and exercise capacity. Since parasympathetic activity is the dominant reversible component of airflow obstruction in COPD, inhaled short-acting anticholinergic agents (SAAC, in particular ipratropium, became an efficient and safe first-line treatment, especially when combined with a short-acting beta2-adrenergic receptor agonist. Even better results were obtained when combining the SAAC ipratropium to a long-acting beta2-adrenergic receptor agonist (LABA, once they became available. Recently, tiotropium bromide, the first of a new class of selective and long-acting anticholinergic agents was introduced for once-daily maintenance treatment of COPD patients. Several large long-term randomised clinical trials comparing tiotropium to placebo as well as to the SAAC ipratropium and the LABA salmeterol, have confirmed the long-acting and superior bronchodilator effect of tiotropium without any evidence of drug tolerance developing. These studies also have clearly demonstrated that tiotropium positively affects several other important health outcomes, such as dyspnoea sensation, exercise capacity, utilisation of rescue bronchodilators, health-related quality of life, COPD exacerbations and hospitalisations because of exacerbations. The improvement in these real-life outcomes appears related to the reduction in both static and dynamic hyperinflation. In all these studies, tiotropium was well tolerated and safe; the only relevant side-effect encountered being dry mouth, usually mild and often transitory. Finally, it has been shown that the combination of tiotropium with a LABA affords superior bronchodilatation than both agents alone, indicating that both classes of long-acting bronchodilators should be

  5. The influence of trial order on learning from reward versus punishment in a probabilistic categorization task: Experimental and computational analyses

    Directory of Open Access Journals (Sweden)

    Ahmed A. Moustafa

    2015-07-01

    Full Text Available Previous research has shown that trial ordering affects cognitive performance, but this has not been not tested using category-learning tasks that differentiate learning from reward and punishment. Here, we tested two groups of healthy young adults using a probabilistic category learning task of reward and punishment in which there are two types of trials (reward, punishment and three possible outcomes: (1 positive feedback for correct responses in reward trials, (2 negative feedback for incorrect responses in punishment trials, and (3 no feedback for incorrect answers in reward trials and correct answers in punishment trials. Hence, trials without feedback are ambiguous, and may represent either successful avoidance of punishment or failure to obtain reward. In Experiment 1, the first group of subjects received an intermixed task in which reward and punishment trials were presented in the same block, as a standard baseline task. In Experiment 2, a second group completed the separated task, in which reward and punishment trials were presented in separate blocks. Additionally, in order to understand the mechanisms underlying performance in the experimental conditions, we fit individual data using a Q-learning model. Results from Experiment 1 show that subjects who completed the intermixed task paradoxically valued the no-feedback outcome as a reinforcer when it occurred on reinforcement-based trials, and as a punisher when it occurred on punishment-based trials. This is supported by patterns of empirical responding, where subjects showed more win-stay behavior following an explicit reward than following an omission of punishment, and more lose-shift behavior following an explicit punisher than following an omission of reward. In Experiment 2, results showed similar performance whether subjects received reward-based or punishment-based trials first. However, when the Q-learning model was applied to these data, there were differences between

  6. Altered glycosylation profile of purified plasma ACT from Alzheimer’s disease

    Directory of Open Access Journals (Sweden)

    Carbone Ilaria

    2010-12-01

    Full Text Available Abstract Background Alzheimer’s disease (AD is one of the most frequent cause of neurodegenerative disorder in the elderly. Inflammation has been implicated in brain degenerative processes and peripheral markers of brain AD related impairment would be useful. Plasma levels of alpha-1-antichymotrypsin (ACT, an acute phase protein and a secondary component of amyloid plaques, are often increased in AD patients and high blood ACT levels correlate with progressive cognitive deterioration. During inflammatory responses changes in the micro-heterogeneity of ACT sugar chains have been described. Methods N-Glycanase digestion from Flavobacterium meningosepticum (PNGase F was performed on both native and denatured purified ACT condition and resolved to Western blot with the purpose to revealed the ACT de-glycosylation pattern. Further characterization of the ACT glycan profile was obtained by a glycoarray; each lectin group in the assay specifically recognizes one or two glycans/epitopes. Lectin-bound ACT produced a glyco-fingerprint and mayor differences between AD and controls samples were assessed by a specific algorithms. Results Western blot analysis of purified ACT after PNGase F treatment and analysis of sugar composition of ACT showed significantly difference in “glyco-fingerprints” patterns from controls (CTR and AD; ACT from AD showing significantly reduced levels of sialic acid. A difference in terminal GlcNac residues appeared to be related with progressive cognitive deterioration. Conclusions Low content of terminal GlcNac and sialic acid in peripheral ACT in AD patients suggests that a different pattern of glycosylation might be a marker of brain inflammation. Moreover ACT glycosylation analysis could be used to predict AD clinical progression and used in clinical trials as surrogate marker of clinical efficacy.

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

    OpenAIRE

    Amaechi Bennett T; Gilbert Gregg H; Gullion Christina M; Vollmer William M; Shugars Daniel A; Bader James D; Brown John P

    2010-01-01

    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/Des...

  8. Clean Air Act. Revision 5

    Energy Technology Data Exchange (ETDEWEB)

    1994-02-15

    This Reference Book contains a current copy of the Clean Air Act, as amended, 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. This Reference Book has been completely revised and is current through February 15, 1994.

  9. SCADA Application for ACTS Technology

    Science.gov (United States)

    Fairbanks, Barry

    1992-01-01

    The results of a system level study done by Hughes Network Systems for NASA are presented. For the supervisory control and data acquisition (SCADA) application, use of Ka-band spot beam satellite technology associated with NASA's Advanced Communication Technology Satellite (ACTS) offers a reduction in Earth station antenna size and transmitter power that may translate into lower system costs. The approaches taken to determine commercial potential of the system are described.

  10. 25 CFR 11.314 - Jury trials.

    Science.gov (United States)

    2010-04-01

    ... Criminal Procedure § 11.314 Jury trials. (a) A defendant has a right, upon demand, to a jury trial in any criminal case: (1) That is punishable by a maximum sentence of one year incarceration; or (2) In which...

  11. Clinical Trials: Key to Medical Progress

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: Key to Medical Progress Past Issues / Summer 2008 ... this page please turn Javascript on. Photo iStock Clinical trials are research studies that test how well new ...

  12. ACTS for distance education in developing countries

    Science.gov (United States)

    Kalu, A.; Ventre, G.

    1995-08-01

    The need for electrical energy supply in the rural communities of developing countries has been well documented. Equally well known is the potential for photovoltaic in cost effectively meeting this need. A major impediment to fulfilling the need is the lack of indigenous personnel with a knowledgeof photovoltaic systems, and the associated infrastructure required to implement project. Various delivery schemes for providing the needed training to developing countries personnel have been investigated. Various train methods and programs that have been employed to remedy the problem have had significant drawbacks in terms of cost, consistency, impact, reach, and sustainability. The hypothesis to be tested in this project posits that satellite-based distance education using ACTS technologies can overcome these impediments. The purpose of the project is to investigate the applicability of the ACTS satellite in providing distance education in photovoltaic systems to developing countries and rural communities. An evaluation of the cost effectiveness of using ACTS unique technologies to overcome identified problems shall be done. The limitations of ACTS in surmounting distance education problems in developing countries shall be investigated. This project will, furthermore, provide training to Savannah State College faculty in photovoltaic (PV) systems and in distance education configurations and models. It will also produce training materials adequate for use in PV training programs via distance education. Savannah State College will, as a consequence become well equipped to play a leading role in the training of minority populations in photovoltaic systems and other renewables through its Center for Advanced Water Technology and Energy Systems. This communication provides the project outline including the specific issues that will be investigated during the project. Also presented i the project design which covers the participations of the various components of a network

  13. Strategies to improve retention in randomised trials

    OpenAIRE

    Brueton, V. C.; Tierney, J.; Stenning, S; Harding, S; Meredith, S.; Nazareth, I; Rait, G

    2013-01-01

    Background Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. Objectives To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. Search met...

  14. Raising the standards of clinical trials and research

    OpenAIRE

    2007-01-01

    The James Lind Library, named after the 18th-century Scottish naval surgeon whose experiments showed that citrus fruits cured scurvy, was launched in 2003 to broaden understanding of clinical trials involving humans by explaining their fundamental principles and their historical development. The online repository receives over 60 000 visitors every three months, and WHO Regional Offices have translated its introductory materials into Arabic, French, Portuguese and Spanish. The library provide...

  15. Taking culture seriously in biomedical HIV prevention trials: a meta-synthesis of qualitative studies.

    Science.gov (United States)

    Rubincam, Clara; Lacombe-Duncan, Ashley; Newman, Peter A

    2016-01-01

    A substantial gap exists between widespread acknowledgement of the importance of incorporating cultural sensitivity in biomedical HIV prevention trials and empirical evidence to guide the operationalization of cultural sensitivity in these trials. We conducted a systematic literature search and qualitative meta-synthesis to explore how culture is conceptualized and operationalized in global biomedical HIV prevention trials. Across 29 studies, the majority (n = 17) were conducted in resource-limited settings. We identified four overarching themes: (1) semantic cultural sensitivity - challenges in communicating scientific terminology into local vernaculars; (2) instrumental cultural sensitivity - understanding historical experiences to guide tailoring of trial activities; (3) budgetary, logistical, and personnel implications of operationalizing cultural sensitivity; and (4) culture as an asset. Future investigations should address how sociocultural considerations are operationalized across the spectrum of trial preparedness, implementation, and dissemination in particular sociocultural contexts, including intervention studies and evaluations of the effectiveness of methods used to operationalize culturally sensitive practices. PMID:26560332

  16. HIV/AIDS Clinical Trials Fact Sheet

    Science.gov (United States)

    HIV Prevention HIV/AIDS Clinical Trials (Last updated 9/15/2015; last reviewed 9/15/2015) Key Points HIV/AIDS clinical ... safe and effective in people. What is an HIV/AIDS clinical trial? HIV/AIDS clinical trials help ...

  17. The Design of Cluster Randomized Crossover Trials

    Science.gov (United States)

    Rietbergen, Charlotte; Moerbeek, Mirjam

    2011-01-01

    The inefficiency induced by between-cluster variation in cluster randomized (CR) trials can be reduced by implementing a crossover (CO) design. In a simple CO trial, each subject receives each treatment in random order. A powerful characteristic of this design is that each subject serves as its own control. In a CR CO trial, clusters of subjects…

  18. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.

  19. Jury selection and jury trial in Spain: between theory and practice

    Directory of Open Access Journals (Sweden)

    Mar Jimeno-Bulnes

    2011-12-01

    Full Text Available The Jury Court in Spain is composed of nine citizens and is headed by a magistrate belonging to the Provincial Court, Chamber of Criminal. These citizens participate as lay assessors in a very particular way. The Spanish Jury Law 5/1995 contemplates its intervention in criminal proceedings as a sort of ‘duty-right’; one hand, inasmuch as it is a right, the law guarantees a remuneration; on the other, inasmuch as it is a duty, the Jury Law does not provide any sort of sanction because of inassistance. Also legal status of the Spanish jurors is established by a complicated system of qualification and disqualifications causes. There are four categories for disqualification: incapacities, incompatibilities, prohibitions and excuses, which contemplate various personal and professional circumstances. In contrast, certain omissions in the regulation may be appreciated such as the conscientious objection for example, which becomes the most controversial question with regard to the duty to act as a juror.The purpose of present paper is to discuss the abover points and examines how jury selection and service actually proceeds in Spanish Jury Courts. An initial reference is made to the composition of the lists of prospective jurors, which includes an explanation of the way in which prospective jurors are designated by random from the electoral census and how the definitive lists are drawn up in each province at two-yearly intervals and delivered to the Provincial Courts. Subsequently, the trial jury selection system is presented along with other measures that relate to jury participation in criminal proceedings, such as the completion of a questionnaire on lawful grounds for disqualification and the distribution of a copy of the ‘jury handbook’ to each selected juror. References are also made to the possibility of challenges for cause and without cause (peremptory challenges both by the parties to the trial, defence and prosecution, as well as to

  20. 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...