Sample records for act trial experience

  1. The Experiment as Act

    DEFF Research Database (Denmark)

    Søndergaard, Morten

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

  2. Experiences from an ACT programme in Copenhagen

    DEFF Research Database (Denmark)

    Benjaminsen, Lars

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

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

    Directory of Open Access Journals (Sweden)

    Young Bridget


    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

  4. Physician and patient benefit–risk preferences from two randomized long-acting injectable antipsychotic trials (United States)

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


    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.

  5. Advanced Communication Technology Satellite (ACTS) multibeam antenna technology verification experiments (United States)

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


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

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

    Directory of Open Access Journals (Sweden)

    Katz EG


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

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

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    Amaechi Bennett T


    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

  8. The European "clinical trial" regulation; relationship with the Jardé Act: a Giens workshop. (United States)

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


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

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

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    Cano Stefan J


    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

  10. Establishing a clinical trials network in nephrology: experience of the Australasian Kidney Trials Network. (United States)

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


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

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

    NARCIS (Netherlands)

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


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

  12. Drawing and acting as user experience research tools

    DEFF Research Database (Denmark)

    Fleury, Alexandre


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

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

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    Rosa C


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

  14. Design and implementation of an experiment scheduling system for the ACTS satellite (United States)

    Ringer, Mark J.


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

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

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    Sevón Tiina


    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

  16. The Impact of CBT and ACT Models Using Psychology Trainee Therapists: A Preliminary Controlled Effectiveness Trial (United States)

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


    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…

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

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    John J. Pilch


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

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



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

  19. Use of the experience sampling method in the context of clinical trials (United States)

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


    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

  20. Student Experience of Oral Communication Assessment Tasks Online from a Multi-Disciplinary Trial (United States)

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


    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…

  1. 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


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

  2. 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


    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.

  3. A randomized trial of ACT bibliotherapy on the mental health of K-12 teachers and staff. (United States)

    Jeffcoat, Tami; Hayes, Steven C


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

  4. The experience of older patients with cancer in phase 1 clinical trials: a qualitative case series. (United States)

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


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

  5. ACGT: advancing clinico-genomic trials on cancer - four years of experience. (United States)

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


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

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


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


    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...


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    Chaoying Tang


    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.

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

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    Sergio Harari


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

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

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


    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.

  10. Trials

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    Michele Fornaro


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

  11. Exploring User Experience of a Telehealth System for the Danish TeleCare North Trial. (United States)

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


    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.

  12. 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)


    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)

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

    Energy Technology Data Exchange (ETDEWEB)

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


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

  14. A phase 2 trial of long-acting TransCon growth hormone in adult GH deficiency. (United States)

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


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

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

    Directory of Open Access Journals (Sweden)

    Charlotte Höybye


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

  16. 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


    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

  17. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia. (United States)

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


    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.

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

    Directory of Open Access Journals (Sweden)

    Claudia Scheid


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

  19. Do Proficiency and Study-Abroad Experience Affect Speech Act Production? Analysis of Appropriateness, Accuracy, and Fluency (United States)

    Taguchi, Naoko


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

  20. 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


    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

  1. 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


    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...

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

    Directory of Open Access Journals (Sweden)

    Bruce H. K. Dobkin, MD


    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.

  3. Genetic differential susceptibility on trial: meta-analytic support from randomized controlled experiments. (United States)

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


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

  4. 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.;


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

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


    Szabo, Eva


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

  6. The sexual history provisions in the Youth Justice and Criminal Evidence Act 1999--a violation of the right to a fair trial? (United States)

    Young, G


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

  7. Experience Sampling-Based Personalized Feedback and Positive Affect: A Randomized Controlled Trial in Depressed Patients (United States)

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


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

  8. [Influence of the Nuremberg physicians' trials--beginning a new era in the ethical judging of human experiments]. (United States)

    Kerpel-Fronius, Sándor


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

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

    Directory of Open Access Journals (Sweden)

    Jessica A Hartmann

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

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

    Directory of Open Access Journals (Sweden)

    Irene Cañamares Orbis


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

  11. Accuracy of effect size estimates from published psychological experiments involving multiple trials. (United States)

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


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

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

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


    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%…

  13. Employing a Mock Trial in a Criminology Course: An Applied Learning Experience. (United States)

    Shepelak, Norma J.


    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)

  14. Nazi Medical Experiment Report: Evidence from the Nuremberg Medical Trial. Teaching with Documents. (United States)

    Haverkamp, Beth; Schamel, Wynell


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

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

    NARCIS (Netherlands)

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


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

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

    DEFF Research Database (Denmark)

    Nørskov, Anders Kehlet


    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...

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

    DEFF Research Database (Denmark)

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


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

  18. 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


    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

  19. A New Level A Type IVIVC for the Rational Design of Clinical Trials Toward Regulatory Approval of Generic Polymeric Long-Acting Injectables. (United States)

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


    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

  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


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

    Directory of Open Access Journals (Sweden)

    Moodley Jothi


    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

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



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

  3. [Possibility of uterus transplantation trial in Czech Republic - indications, research and clinical experience]. (United States)

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


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

  4. Working with Community Health Workers as 'volunteers' in a vaccine trial: practical and ethical experiences and implications. (United States)

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


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

  5. Understanding involvement in surgical orthopaedic randomized controlled trials: A qualitative study of patient and health professional views and experiences (United States)

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


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

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

    DEFF Research Database (Denmark)

    Nørskov, Anders Kehlet


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

  7. Up-date on the NeoVitaA Trial: Obstacles, challenges, perspectives, and local experiences. (United States)

    Meyer, Sascha; Gortner, Ludwig


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

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

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


    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.

  9. Safety profile of Cerebrolysin: clinical experience from dementia and stroke trials. (United States)

    Thome, J; Doppler, E


    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


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

    Gray, K. L.


    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.

  12. The Juggling Act: A Phenomenological Study of Gifted and Talented Girls' Experiences with Facebook (United States)

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


    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…

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

    Directory of Open Access Journals (Sweden)

    Lake JE


    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. 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


    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

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

    DEFF Research Database (Denmark)

    Nørskov, Anders Kehlet


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

  16. Retrocausation acting in the single-electron double-slit interference experiment (United States)

    Hokkyo, Noboru

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

  17. Simulation of plume dispersion from single release in Fusion Field Trial-07 experiment (United States)

    Singh, Sarvesh Kumar; Sharan, Maithili


    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.

  18. Affordable Care Act Qualified Health Plan Enrollment for AIDS Drug Assistance Program Clients: Virginia's Experience and Best Practices. (United States)

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


    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.

  19. 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)


    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)

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

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


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

  1. Simulation of plume dispersion of multiple releases in Fusion Field Trial-07 experiment (United States)

    Pandey, Gavendra; Sharan, Maithili


    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.

  2. High-dose intravenous immunoglobulin in inflammatory myopathies: experience based on controlled clinical trials. (United States)

    Dalakas, M C


    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.

  3. Preoperative airway assessment - experience gained from a multicentre cluster randomised trial and the Danish Anaesthesia Database. (United States)

    Nørskov, Anders Kehlet


    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

  4. 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.

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

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


    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.

  6. Can Facebook Be Used for Research? Experiences Using Facebook to Recruit Pregnant Women for a Randomized Controlled Trial (United States)

    Adam, Laura M; Manca, Donna P


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

  7. High sodium causes hypertension: evidence from clinical trials and animal experiments. (United States)

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


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

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

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    Ciuffreda Libero


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

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

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    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

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

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    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

  11. Brain stimulation and brain repair--rTMS: from animal experiment to clinical trials--what do we know? (United States)

    Platz, Thomas; Rothwell, John C


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

  12. Randomized Controlled Trial of Teaching Methods: Do Classroom Experiments Improve Economic Education in High Schools? (United States)

    Eisenkopf, Gerald; Sulser, Pascal A.


    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…

  13. Motivational Interviewing May Improve Exercise Experience for People with Multiple Sclerosis: A Small Randomized Trial (United States)

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


    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…

  14. Forensic age estimation in anti-piracy trials in Seychelles: Experiences and challenges faced. (United States)

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


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

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

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    Bill Irwin


    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.

  16. Facilitated patient experience feedback can improve nursing care: a pilot study for a phase III cluster randomised controlled trial (United States)


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

  17. Experience with Subgam, a Subcutaneously Administered Human Normal Immunoglobulin (

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    Clive Dash

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

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

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    Kavit Natujwa


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

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

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


    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.

  20. Feasibility of male hormonal contraception: lessons from clinical trials and animal experiments. (United States)

    Oduwole, Olayiwola O; Huhtaniemi, Ilpo T


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

  1. Blood Trials: Transfusions, Injections, and Experiments in Africa, 1890-1920. (United States)

    Sunseri, Thaddeus


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

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

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    Ann Hopton

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

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

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    Chrispijn Melissa


    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 NCT01157858

  4. Fathers' and Mothers' Experiences with Participation in Part C of the Individuals with Disabilities Education Act Early Intervention Process (United States)

    Baden, Kristin Marie


    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…

  5. The accountable health care act of Massachusetts: mixed results for an experiment in universal health care coverage. (United States)

    Norbash, Alexander; Hindson, David; Heineke, Janelle


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

  6. A therapeutic application of the experience sampling method in the treatment of depression: a randomized controlled trial (United States)

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


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

  7. 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

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    Sarris Jerome


    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

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


    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

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

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    Giovanni Pagano


    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.

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

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    van der Wal Gerrit


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

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

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


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

  12. Challenges in conducting multicenter, multicultural, and multilingual trials: a view from the literature and real-life experience reports. (United States)

    Hanson, Beate; De Faoite, Diarmuid


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

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

    NARCIS (Netherlands)

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


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

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

    NARCIS (Netherlands)

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


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

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

    Directory of Open Access Journals (Sweden)

    Adalatkhah H


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

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

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    Reijonsaari Karita


    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

  17. After the Gold Rush: Questioning the "Gold Standard" and Reappraising the Status of Experiment and Randomized Controlled Trials in Education (United States)

    Thomas, Gary


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

  18. 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


    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

  19. 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


    Full Text Available Abstract Background This post hoc analysis (trial registration: 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

  20. Lessons learned while conducting a clinical trial to facilitate evidence-based practice: the neophyte researcher experience. (United States)

    Brim, Carla B; Schoonover, Heather D


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

  1. 78 FR 1206 - Privacy Act of 1974; System of Records-Evaluation of the Pell Grant Experiments Under the... (United States)


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

  2. Indispensable value of clinical trials in the modernization of traditional Chinese medicine: 12 years' experience at CUHK and future perspectives. (United States)

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


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

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


    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

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


    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

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


    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.

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

    Directory of Open Access Journals (Sweden)

    Callis Duffin K


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

  7. 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]. (United States)

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


    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.

  8. 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


    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.

  9. Act local, think global: how the Malawi experience of scaling up antiretroviral treatment has informed global policy. (United States)

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


    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.

  10. Supplemental vibrational force does not reduce pain experience during initial alignment with fixed orthodontic appliances: a multicenter randomized clinical trial. (United States)

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


    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.

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

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


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

  12. 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. (United States)

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


    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.

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

    Institute of Scientific and Technical Information of China (English)

    周巧霞; 鲁继光; 王之敏; 刘峰


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

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

    Directory of Open Access Journals (Sweden)

    Matthew R Weir


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

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

    Energy Technology Data Exchange (ETDEWEB)

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


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

  16. 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....

  17. 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


    . 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......-term pregnancies (51 vs 50), premature deliveries (21 vs 27), spontaneous miscarriages (12 vs 15), elective terminations (15 vs 14) and other outcomes (1 vs 2) were similar in the candesartan and placebo groups. There were two stillbirths and two 'sick babies' in the candesartan group, and one stillbirth, eight...... '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...

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


    Chacón Alvarado, Lucía; Miranda Arguedas, Alice


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

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

    Bergström, M; Kieler, H; Waldenström, U


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

  20. 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


    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.

  1. 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


    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

  2. Lumacaftor alone and combined with ivacaftor: preclinical and clinical trial experience of F508del CFTR correction. (United States)

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


    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.

  3. 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


    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.

  4. Clinical Trials (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 ...

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

    Institute of Scientific and Technical Information of China (English)

    梁莉; 焦凯; 李丹; 乔华; 常威; 冯泽岸; 王婷


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

  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. (United States)

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


    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.

  7. Fundamentals of clinical trials

    CERN Document Server

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


    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 ...

  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


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

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


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

  10. 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 (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


    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. Clinical Trials (United States)

    ... they are receiving. Other clinical trials involve a crossover design, where participants are randomly assigned to take a new treatment, a treatment already in use, and/or a placebo for a specified time ... If I am involved in a "crossover" clinical trial, can I go back to the ...

  12. 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


    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

  13. Long-acting muscarinic antagonists

    DEFF Research Database (Denmark)

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


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

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

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


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

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

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


    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.

  16. Participating in Clinical Trials

    Medline Plus

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

  17. Stroke Trials Registry (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 ...

  18. 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


    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

  19. 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


    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.

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

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


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

  1. 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;


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

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

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


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

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

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


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

  4. The Trial (United States)

    Bryant, Jen


    Growing up in Flemington, New Jersey, put Jen Bryant in the heart of the lore behind the Lindbergh baby kidnapping. Family stories of the events of the day and extensive research led to "The Trial," a novel in verse. The first several parts of this novel are included here.

  5. 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


    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.

  6. Experience With Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study (United States)


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

  7. 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, ...

  8. Real-world experience with interferon-free, direct acting antiviral therapies in Asian Americans with chronic hepatitis C and advanced liver disease (United States)

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


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

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

    Directory of Open Access Journals (Sweden)

    Brian Slattery


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

  10. The Act of Walking

    DEFF Research Database (Denmark)

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


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

  11. What Are Clinical Trials? (United States)

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

  12. Participating in Clinical Trials (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 ...

  13. Participating in Clinical Trials

    Medline Plus

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

  14. Bayes' postulate for trinomial trials (United States)

    Diniz, M. A.; Polpo, A.


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

  15. 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


    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.

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

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


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

  17. Legislation for trial registration and data transparency. (United States)

    Bian, Zhao-Xiang; Wu, Tai-Xiang


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

  18. How Experimental Trial Context Affects Perceptual Categorization

    Directory of Open Access Journals (Sweden)

    Thomas J Palmeri


    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.

  19. Teaching Speech Acts

    Directory of Open Access Journals (Sweden)

    Teaching Speech Acts


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

  20. Reward and punishment act as distinct factors in guiding behavior. (United States)

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


    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.

  1. '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)

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    Glynne-Jones, Rob, E-mail: [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)


    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.

  2. Experiences and Perceptions of Problem Gamblers on Cognitive and Exposure Therapies When Taking Part in a Randomised Controlled Trial: A Qualitative Study. (United States)

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


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

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

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


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

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

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


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

  5. A prospective, randomized, multicentre trial for the treatment of refractory status epilepticus; experiences from evaluating the effect of the novel drug candidate, NS1209. (United States)

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


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

  6. Experiences of Parents with the Reading to Learn Approach: A Randomised Control Trial Initiative to Improve Literacy and Numeracy in Kenya and Uganda (United States)

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


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

  7. US medical researchers, the Nuremberg Doctors Trial, and the Nuremberg Code. A review of findings of the Advisory Committee on Human Radiation Experiments. (United States)

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


    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.

  8. Data monitoring committees for pragmatic clinical trials. (United States)

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


    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

  9. Types of Treatment: Clinical Trials (United States)

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

  10. HVAC Trials. (United States)

    Greim, Clifton W.; D'Angelo, David


    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)

  11. Progress in the prognosis of adult Hodgkin's lymphoma in the past 35 years through clinical trials in Argentina: a GATLA experience. (United States)

    Pavlovsky, Santiago; Lastiri, Francisco


    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

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


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

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

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


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

  14. 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 ...

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

    Directory of Open Access Journals (Sweden)

    Falk Lieder

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

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

    Institute of Scientific and Technical Information of China (English)



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

  17. 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


    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.

  18. 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


    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

  19. Participating in Clinical Trials

    Medline Plus

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

  20. Microbicide clinical trial adherence: insights for introduction

    Directory of Open Access Journals (Sweden)

    Cynthia Woodsong


    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.

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

    Directory of Open Access Journals (Sweden)

    G. P. Viégas


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

  2. Clinical Trials in Vision Research (United States)

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

  3. How Do Clinical Trials Work? (United States)

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

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

    DEFF Research Database (Denmark)

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


    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...

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

    Directory of Open Access Journals (Sweden)

    Scardino Peter T


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

  6. Autism: Why Act Early? (United States)

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

  7. 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


    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

  8. ACT-asthma control y tratamiento para niños: a progress report. (United States)

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


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

  9. The Effects of a Single Reminder Trial on Retention of a Motor Skill (United States)

    Fairbrother, Jeffrey T.; Shea, John B.


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

  10. Indirect Speech Acts

    Institute of Scientific and Technical Information of China (English)



    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.

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

    Directory of Open Access Journals (Sweden)

    Mpimbaza Arthur


    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

  12. GPON FTTH trial: lessons learned (United States)

    Weis, Erik; Hölzl, Rainer; Breuer, Dirk; Lange, Christoph


    This paper reports on a FTTH field trial with GPON (Gigabit-capable passive optical network) technology in the network of Deutsche Telekom in the region of the cities of Berlin and Potsdam. Focus of this trial was to gain practical experience regarding GPON technology, fibre installation in existing ducts with micro duct technology, fibre cabling in customer buildings and impact on operational processes. Furthermore it is reported on an initial Deutsche Telekom FTTB deployment based on GPON technology in the city of Dresden with the main targets to obtain practical deployment and operation experiences with fibre-based access networks and to provide broadband access to a part of the city formerly not servable by DSL (digital subscriber line) technology.

  13. Informed Consent (Clinical Trials) (United States)

    ... Research Cancer Treatment Types of Treatment Side Effects Clinical Trials Information A to Z List of Cancer Drugs ... Staging Prognosis Treatment Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings & Cancer ...

  14. Research Areas - Clinical Trials (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.

  15. Hepatitis C: Clinical Trials (United States)

    ... and Public Home » Hepatitis C » Treatment Decisions Viral Hepatitis Menu Menu Viral Hepatitis Viral Hepatitis Home For ... can I find out about participating in a hepatitis C clinical trial? Many trials are being conducted ...

  16. Ethics of clinical trials in Nigeria. (United States)

    Okonta, Patrick I


    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.

  17. Ethics of clinical trials in Nigeria

    Directory of Open Access Journals (Sweden)

    Patrick I Okonta


    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.

  18. ACT Verbal Prep Course

    CERN Document Server

    Standridge, Nathan


    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

  19. Understanding noninferiority trials

    Directory of Open Access Journals (Sweden)

    Seokyung Hahn


    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.

  20. A pragmatic cluster randomised trial evaluating three implementation interventions

    Directory of Open Access Journals (Sweden)

    Rycroft-Malone Jo


    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

  1. Marine Mammal Protection Act (United States)

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

  2. The Apocryphal Acts Of Andrew

    NARCIS (Netherlands)

    Bremmer, Jan N.


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

  3. Differences in trial knowledge and motives for participation among cancer patients in phase 3 clinical trials. (United States)

    Godskesen, T M; Kihlbom, U; Nordin, K; Silén, M; Nygren, P


    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.

  4. Clean Water Act (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...

  5. Affordable Care Act (ACA) (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...

  6. Acts of Research

    DEFF Research Database (Denmark)

    Nelund, Sidsel

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

  7. Endangered Species Act (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...

  8. Energy Policy Act (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)...

  9. National Environmental Policy Act (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...

  10. Abandoned Shipwreck Act (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...

  11. Marine Pollution Prevention Act (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)...

  12. ACT250 Districts (United States)

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

  13. 76 FR 18226 - Guidance for Industry on Postmarketing Studies and Clinical Trials-Implementation of Section 505... (United States)


    ... 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...

  14. AlphaACT (United States)


    CBR can be found in the world around us (e.g., a doctor’s diagnosis based on a prior patient case, a lawyer preparing arguments based on legal ... metaphors in decision research. Judgment & Decision Making, 3(3), 195-204. Payne, J., Bettman, J., & Johnson, E. (1993). The Adaptive Decision Maker...alphaact. com 64 AlphaACT HAZMAT User Guide 8.3 Changing Measurement Units AlphaACT HAZMAT lets you show distances in either metric or English

  15. 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


    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.

  16. Adubação do algodoeiro VII: ensaios com diversos adubos fosfatados (1.ª série Fertilizer experiments with cotton VII: trials with various phosphorus fertilizers (1st. .series

    Directory of Open Access Journals (Sweden)

    O. S. Neves


    started before 1941, five of which can be utilized to show the effects on the yields. The latter were conducted in the same plots for three or more seasons. The yearly applications of P2O5 varied according to the experiment from 60 to 90 kilograms per hectare and were always used in the presence of nitrogen and potash. The various phosphates tested, including ordinary and granulated superphosphate, precipitated phosphate, Rhenaniaphosphate, Thomas slag, and bone meal, gave practically the same results. The authors warn, however, that the small number of experiments and the conditions under which they were conducted do not as yet permit to draw definite conclusions on the subject. In four trials, which included plots fertilized only with nitrogen and potash, the mean effect of phosphorus on the yield of seed cotton varied from fair to very high. The latter offered an excellent opportunity for verifying the influence of phosphorus on some characteristics of the cotton plant and its fruits. Phosphorus increased also the weight and height of the plants, but not so much as the yield of seed cotton. When the first picking was made early, it was observed that phosphorus hastened the fruiting march. Phosphorus increased the weight of the bolls, but did not practically affect the lint percentage and length. The residual effect of phosphorus was determined in two of the experiments. Although they were conducted on the "terra-roxa-misturada" type of soil, that effect was high and no difference was observed between that of superphosphate and the relatively insoluble phosphates.

  17. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P


    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...

  18. 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 ...

  19. Juvenile Competency to Stand Trial. (United States)

    Stepanyan, Sofia T; Sidhu, Shawn S; Bath, Eraka


    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.

  20. WP6 - Application Integration, Trials and Evaluation

    DEFF Research Database (Denmark)

    Prasad, Neeli R.; Cetin, Bilge Kartal; Moran, Humberto;


    This deliverable contains all the details on the planning, description of business cases, business goals stakeholders, IT infrastructure, evaluation guidelines and other aspects of the pilot trials, that are envisioned for demonstrating the benefits of the ASPIRE middleware platform. These pilot...... trials mainly consist of controlled and carefully designed experiments that will be organized either by those partners of the consortium who have previous experience on demos or similar events for small and medium enterprises (SMEs), or by other institutions that have accepted to test the ASPIRE...... middleware platform during their trials. The pilots aim to cover different business sectors, scenarios and applications related to RFID (Radio Frequency Identification) systems, thus giving a diverse set of outcomes that will be able to provide a better perspective on how ASPIRE will help in the reduction...

  1. Experience about causality assessment of fibrinogen in phase Ⅰ clinical trial of Chinese herbal medicine%中药新药Ⅰ期临床试验中纤维蛋白原关联性判断的体会

    Institute of Scientific and Technical Information of China (English)

    鲁喦; 李涛; 贾增芹; 高蕊; 唐旭东


    目的:探讨Ⅰ期临床试验中纤维蛋白原指标评价存在的问题及其解决办法.方法:通过一个新药Ⅰ期临床试验案例对受试者的纤维蛋白原检测结果进行分析.结果:单次给药试验的30例受试者中,26例出现纤维蛋白原降低,但无量效关系;在随后的连续给药试验中加入安慰剂对照组,其结果纤维蛋白原在高低剂量组中无量效关系,试验药物组和安慰剂对照组纤维蛋白原出现一致性变化,证实纤维蛋白原的变化与试验药物无关.结论:纤维蛋白原检测受到多种因素的影响,应规范操作过程减少对其的影响;应制定适当的检测指标纳入标准;必要时可增加安慰剂对照,采用多种手段对实验室不良事件的关联性进行综合判断.%AIM: To explore the fibrinogen e-valuation problems and solution in phase I clinical trials. METHODS: Through a new phase I trial,there were 54 cases in phase I clinical trial volunteers' fibrinogen test, and analysised the results. RESULTS:Fibrinogen change did not exist consistency , between 30 cases in single dose trial,there were 26 cases fibrinogen reduced ; In subsequent continuous drug trials to join the comfort drug group, the results of the two groups still did not exist consistency between groups, trial drug and placebo group fibrinogen appear consistency changes , confirm the changesof fibrinogen is none of test drug. CONCLUSION: Fibrinogen test is affected by many kinds of factors, should be standardized operation process to reduce the influence; identify proper testing index range and inclusion criteria; can install placebo group if necessary, using a variety of means for causality assessment of the laboratory adverse events.

  2. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Trials Insurance Coverage and Clinical Trials How to Work With Your Health Insurance Plan Federal Government Programs Patient Safety Informed Consent Children's Assent Scientific Review Ending Trials Early Deciding to Take Part ...

  3. Empowering natural clinical trial advocates: nurses and outreach workers. (United States)

    Mitschke, Diane B; Cassel, Kevin; Higuchi, Paula


    Cancer clinical trials are essential to advancing the prevention and treatment of cancer, yet adult participation rates in clinical trials remain abysmal. Despite the essential contributions of clinical trials to science and medicine, adult participation in clinical trials remains exceedingly low, with only 2%-4% of all adult patients with cancer in the U.S. participating in clinical trials. Clinical trials accrual rates in Hawai'i follow this national trend of less than 3% of eligible patients participating in trials. Recognizing the need to increase awareness about clinical trials, the National Cancer Institute's Cancer Information Service-Pacific Region, through the Hawai'i Clinical Trials Education Coalition, has employed strategic dissemination plans to train and educate key target audiences, including registered nurses, nursing students, and community outreach workers about the availability of over 90 cancer clinical trials in Hawai'i. Previous research suggests that nurses often play a vital role in increasing a patient's understanding of clinical trials and may also act as a patient advocate in regards to participation in a clinical trial. A train-the-trainer model curriculum was developed using the Clinical Trials Education Series (CTES), a collection of multi-level resources designed by the National Cancer Institute, to educate various constituents about clinical trials. The training curriculum and workshop format is adapted based on both formal and informal needs assessments conducted with audiences prior to the planned training, yet key elements remain central to the training model. In addition, an interactive, internet-based case study was developed using local place names and cultural cues to allow training participants to engage in realistic and practical methods for locating and sharing information about clinical trials with patients and the public. This training model has been implemented in a variety of settings including three statewide nursing

  4. The ACTS multibeam antenna (United States)

    Regier, Frank A.


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

  5. The ACTS multibeam antenna (United States)

    Regier, Frank A.


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




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

  7. TBCS/Chameleon Utility Trial Report (United States)


    mission contexts, different mission tasks, different time pressures and different team roles . For example, the levels of detail to support planning before...predictive value of the results. • the low level of experience in the personnel who played combat team roles in the trial • a single participant at each

  8. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P;


    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....

  9. ST–ACTS

    DEFF Research Database (Denmark)

    Gidofalvi, Gyozo; Pedersen, Torben Bach


    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...

  10. Acting like a Pro (United States)

    Walker, Marlon A.


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

  11. 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...

  12. Trial-by-trial identification of categorization strategy using iterative decision-bound modeling. (United States)

    Hélie, Sébastien; Turner, Benjamin O; Crossley, Matthew J; Ell, Shawn W; Ashby, F Gregory


    Identifying the strategy that participants use in laboratory experiments is crucial in interpreting the results of behavioral experiments. This article introduces a new modeling procedure called iterative decision-bound modeling (iDBM), which iteratively fits decision-bound models to the trial-by-trial responses generated from single participants in perceptual categorization experiments. The goals of iDBM are to identify: (1) all response strategies used by a participant, (2) changes in response strategy, and (3) the trial number at which each change occurs. The new method is validated by testing its ability to identify the response strategies used in noisy simulated data. The benchmark simulation results show that iDBM is able to detect and identify strategy switches during an experiment and accurately estimate the trial number at which the strategy change occurs in low to moderate noise conditions. The new method is then used to reanalyze data from Ell and Ashby (2006). Applying iDBM revealed that increasing category overlap in an information-integration category learning task increased the proportion of participants who abandoned explicit rules, and reduced the number of training trials needed to abandon rules in favor of a procedural strategy. Finally, we discuss new research questions made possible through iDBM.

  13. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase ...

  14. Anchor Trial Launch (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

  15. 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, ...

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... a disease. A clinical trial may compare experimental products or tests to those already available or may ... Institutes of Health | U.S. Department of Health & Human Services Customer Support | Accessibility | Copyright | Privacy | Viewers and Players

  17. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... new tests that could identify a disease in its early stages. Usually, trial participants must show signs ... often healthy people (20 to 80), to judge its safety and side effects, and to find the ...

  18. 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 ...

  19. Polyp Prevention Trial (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.

  20. (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...

  1. Falsificationism and clinical trials. (United States)

    Senn, S J


    The relevance of the philosophy of Sir Karl Popper to the planning, conduct and analysis of clinical trials is examined. It is shown that blinding and randomization can only be regarded as valuable for the purpose of refuting universal hypotheses. The purpose of inclusion criteria is also examined. It is concluded that a misplaced belief in induction is responsible for many false notions regarding clinical trials.

  2. Resource utilization implications of treatment were able to be assessed from appropriately reported clinical trial data

    NARCIS (Netherlands)

    Poole-Wilson, Philip A.; Kirwan, Bridget-Anne; Voko, Zoltan; de Brouwer, Sophie; Dunselman, Peter H. J. M.; van Dalen, Frederik J.; Lubsen, Jacobus


    Background and Objective: Published clinical trial data rarely allow assessment of the health care resource utilization implications of treatment. We give an example of how these can be assessed given appropriate tabulation of data. Methods: Data from a trial comparing long-acting nifedipine gastroi


    Directory of Open Access Journals (Sweden)

    Phyllis Kaburise


    Full Text Available Speech Act Theory (SAT, a theory in pragmatics, is an attempt to describe what happens during linguistic interactions. Inherent within SAT is the idea that language forms and intentions are relatively formulaic and that there is a direct correspondence between sentence forms (for example, in terms of structure and lexicon and the function or meaning of an utterance. The contention offered in this paper is that when such a correspondence does not exist, as in indirect speech utterances, this creates challenges for English second language speakers and may result in miscommunication. This arises because indirect speech acts allow speakers to employ various pragmatic devices such as inference, implicature, presuppositions and context clues to transmit their messages. Such devices, operating within the non-literal level of language competence, may pose challenges for ESL learners.

  4. [Multi-national clinical trial in circulatory disorders]. (United States)

    Takahashi, Kihito


    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.

  5. Toxic Substances Control Act

    Energy Technology Data Exchange (ETDEWEB)


    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).

  6. AAB and ABA Renewal as a Function of the Number of Extinction Trials in Conditioned Taste Aversion (United States)

    Rosas, Juan M.; Garcia-Gutierrez, Ana; Callejas-Aguilera, Jose E.


    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…

  7. Franz Kafka's The Trial: guilty or innocent? (United States)

    Siegel, E


    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.

  8. Ethics and clinical trials. (United States)

    Chassany, O; Duracinský, M


    The current reference guideline about ethics in clinical trials is the Declaration of Helsinki of human rights in medical research. Three major principles are emphasised: respect of the patient to accept or not to participate in a trial, the constraints and the presumed risks must be acceptable for patients included in a study, and vulnerable subjects should not participate in studies. The investigator is responsible for obtaining a free and well-informed consent from patients before their inclusion in a study. Where possible, a new drug should always first be compared to placebo in order to prove its superiority. Else, a small-sized trial comparing a new drug versus a reference treatment can lead to an erroneous conclusion of absence of difference. Moreover, good results or improvement are obtained in at least 30% of cases with placebo, whatever the disease. The use of placebo is unethical in life-threatening diseases and when an effective proved drug exists. The use of placebo is ethical in severe diseases with no efficient drug, in some severe diseases even when an active reference treatment is available, and in all moderate and functional diseases. In order to detect flawed studies, most journals now ask for any manuscript submitted and reporting results of a randomised clinical trial to join a checklist in order to verify the quality of the trial. Finally, it remains the responsibility of the doctor to decide whether or not a protocol is ethical, to participate or not and to include patients or not.

  9. Williamson Act - The California Land Conservation Act of 1965 (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...

  10. Optimizing detector trials for humanitarian demining (United States)

    Gaal, Mate; Baer, Sylke; Bloodworth, Thomas J.; Guelle, Dieter; Lewis, Adam M.; Mueller, Christina; Scharmach, Martina


    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.

  11. The FOCUS trial

    DEFF Research Database (Denmark)

    Glenthøj, Louise B; Fagerlund, Birgitte; Randers, Lasse


    trial enrolling 126 patients meeting the standardised criteria of being at UHR for psychosis. Patients are recruited from psychiatric in- and outpatient facilities in the Copenhagen catchment area. Patients are randomised to one of the two treatment arms: cognitive remediation plus standard treatment...... functioning, psychosis-like symptoms, negative symptomatology, and depressive symptomatology as measured with the Personal and Social Performance Scale, Brief Psychiatric Rating Scale-Expanded Version, Scale for the Assessment of Negative Symptoms, and the Montgomery-Åsberg Depression Rating Scale. DISCUSSION......: This is the first trial to evaluate the effects of neurocognitive and social cognitive remediation in UHR patients. The FOCUS trial results will provide evidence on the effect of targeted and comprehensive cognitive rehabilitation on cognition, daily living, and symptomatology as well as long-term outcome...

  12. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M


    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...... of reasons but in particular, to determine whether biomarkers are useful in identifying those individuals most likely to receive clinically important benefits from an intervention; and to determine whether biomarkers are useful for identifying individuals at earlier stages of OA in order to institute...... both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials...

  13. Improving data transparency in clinical trials using blockchain smart contracts. (United States)

    Nugent, Timothy; Upton, David; Cimpoesu, Mihai


    The scientific credibility of findings from clinical trials can be undermined by a range of problems including missing data, endpoint switching, data dredging, and selective publication. Together, these issues have contributed to systematically distorted perceptions regarding the benefits and risks of treatments. While these issues have been well documented and widely discussed within the profession, legislative intervention has seen limited success. Recently, a method was described for using a blockchain to prove the existence of documents describing pre-specified endpoints in clinical trials. Here, we extend the idea by using smart contracts - code, and data, that resides at a specific address in a blockchain, and whose execution is cryptographically validated by the network - to demonstrate how trust in clinical trials can be enforced and data manipulation eliminated. We show that blockchain smart contracts provide a novel technological solution to the data manipulation problem, by acting as trusted administrators and providing an immutable record of trial history.

  14. Virtual Acts of Balance!

    DEFF Research Database (Denmark)

    Madsen, Anders Koed


    improve 'knowledge-democracy' in different ways. The paper denotes such portals 'virtual technologies of knowledge management' and it uses the documental data as a window to analyze and discuss the infrastructural choices of such portals. The analysis is grounded in theories related to 'Social....... It is especially emphasized how technical web-ontologies implicitly carries with them deeper philosophical ontologies about phanomena such as 'politic', 'scientific intentionality' and 'freedom'. The compromise between these technical influences and the social intentions is described as a 'virtual act of balance...

  15. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.;


    The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct...... and index knee, describing interventions, patient-reported and physical performance measures, structural outcome measures, biochemical biomarkers, and reporting recommendations. In summary, the working group identified 25 recommendations that represent the current best practices regarding clinical trials...... that target symptom or structure modification among individuals with knee OA. These updated recommendations incorporate novel technologies (e.g., magnetic resonance imaging (MRI)) and strategies to address the heterogeneity of knee OA....

  16. Pre-trial evaluation of the potential for unblinding in drug trials: a prototype example. (United States)

    Walter, S D; Awasthi, Shally; Jeyaseelan, L


    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.

  17. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial

    DEFF Research Database (Denmark)

    Madsbad, Sten; Schmitz, Ole; Ranstam, Jonas;


    OBJECTIVE: Liraglutide is a long-acting glucagon-like peptide 1 analog designed for once daily injection. This study assessed the efficacy and safety of liraglutide after 12 weeks of treatment in type 2 diabetic patients. RESEARCH DESIGN AND METHODS: A double-blind, randomized, parallel...

  18. Novel ocular antihypertensive compounds in clinical trials

    Directory of Open Access Journals (Sweden)

    Chen J


    Full Text Available June Chen1, Stephen A Runyan1, Michael R Robinson21Department of Biological Sciences, 2Ophthalmology Clinical Research, Allergan, Inc, Irvine, CA, USAIntroduction: Glaucoma is a multifactorial disease characterized by progressive optic nerve injury and visual field defects. Elevated intraocular pressure (IOP is the most widely recognized risk factor for the onset and progression of open-angle glaucoma, and IOP-lowering medications comprise the primary treatment strategy. IOP elevation in glaucoma is associated with diminished or obstructed aqueous humor outflow. Pharmacotherapy reduces IOP by suppressing aqueous inflow and/or increasing aqueous outflow.Purpose: This review focuses on novel non-FDA approved ocular antihypertensive compounds being investigated for IOP reduction in ocular hypertensive and glaucoma patients in active clinical trials within approximately the past 2 years.Methods: The mode of IOP reduction, pharmacology, efficacy, and safety of these new agents were assessed. Relevant drug efficacy and safety trials were identified from searches of various scientific literature databases and clinical trial registries. Compounds with no specified drug class, insufficient background information, reformulations, and fixed-combinations of marketed drugs were not considered.Results: The investigational agents identified comprise those that act on the same targets of established drug classes approved by the FDA (ie, prostaglandin analogs and β-adrenergic blockers as well as agents belonging to novel drug classes with unique mechanisms of action. Novel targets and compounds evaluated in clinical trials include an actin polymerization inhibitor (ie, latrunculin, Rho-associated protein kinase inhibitors, adenosine receptor analogs, an angiotensin II type 1 receptor antagonist, cannabinoid receptor agonists, and a serotonin receptor antagonist.Conclusion: The clinical value of novel compounds for the treatment of glaucoma will depend

  19. Affordable Care Act and Women (United States)

    ... Outcomes Research Trust Fund (PCORTF) Poverty Poverty Guidelines Poverty Analysis Teen Pregnancy Prevention Homelessness MACRA Publications Data and Tools Evaluation Database The Affordable Care Act and Women 03/20/2012 Home The Affordable Care Act ...

  20. 78 FR 73466 - Privacy Act (United States)


    ... 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...

  1. Interactive Approach on Experiments in Mechanical Engineering : Vibration (United States)

    Kumon, Makoto; Torigoe, Ippei; Mizumoto, Ikuro; Yamaguchi, Teruo; Kohzawa, Ryuichi; Ohshima, Yasutaka

    Experiments in the engineering education play important roles in motivating students to study voluntarily. A trial aiming to enhance this effect in the experiment of vibration at Mechanical System Engineering, Kumamoto University is introduced. The trial consists of 1) oral presentation by students, 2) web-based learning system and 3) feedback through reports. An evaluation by questionnaire was conducted to show the validity of this trial. This result revealed that the trial succeeded to encourage students.

  2. Acting Antarctica: science on stage (United States)

    Ciceri, Piera; Tizzoni, Paola; Pierro, Luigia


    Key-words: Polar science, Earth science, Theatre, Hands on activities The legendary Antarctic Expedition of sir E. Shackleton and his crew of 27 aboard the Endurance (1914/16) trapped in the Antarctic ice has become the starting point to learn about Polar Science and Climate Change. While the students were involved into this incredible adventure by the astonishing images of the Australian photographer Frank Hurley (who joined the crew), they discovered the world in which this story happened. Students were then involved in hands-on activities and role plays and have become the writers of the play "Uomini a scienza ai confini del mondo". They act the story of Shackelton's expedition and they tell at the same time to the audience about ice pack, ice cores and their role in understanding the past of the climate, physical and geographical characteristic of polar regions, thermal phenomena related to adaptations of polar animals, solar radiation at different latitude, day/night duration. The theater was the place to "stage" some scientific experiments and to explain the current research carried out in polar regions and their importance in climate change studies and to stress some similarities between Antarctica and space. The project was carried out from teachers of science, letters and geography and was born in collaboration with the "Piccolo Teatro di Milano" and the association "Science Under 18" with the support of a professional actor and director and was played for other schools at "EXPO 2015" in Milano (Italy). In our opinion drama activities improve reading comprehension, and both verbal and non-verbal communication skills. To be able to write and to act, students need a deep understanding of contents. Arts, including theatre, are a good key to involve emotionally students. To have an audience different from their own teachers and classmates offers a real task and the opportunity to play and let grow real skills.

  3. Trial-by-trial switching between procedural and declarative categorization systems. (United States)

    Crossley, Matthew J; Roeder, Jessica L; Helie, Sebastien; Ashby, F Gregory


    Considerable evidence suggests that human category learning recruits multiple memory systems. A popular assumption is that procedural memory is used to form stimulus-to-response mappings, whereas declarative memory is used to form and test explicit rules about category membership. The multiple systems framework has been successful in motivating and accounting for a broad array of empirical observations over the past 20 years. Even so, only a couple of studies have examined how the different categorization systems interact. Both previous studies suggest that switching between explicit and procedural responding is extremely difficult. But they leave unanswered the critical questions of whether trial-by-trial system switching is possible, and if so, whether it is qualitatively different than trial-by-trial switching between two explicit tasks. The experiment described in this article addressed these questions. The results (1) confirm that effective trial-by-trial system switching, although difficult, is possible; (2) suggest that switching between tasks mediated by different memory systems is more difficult than switching between two declarative memory tasks; and (3) point to a serious shortcoming of current category-learning theories.

  4. FCC and the Sunshine Act. (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…

  5. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.;


    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...

  6. Hepatitis C: Clinical Trials (United States)

    ... will not know if you are taking the medicine or the placebo until the clinical trial is over. How do ... can already get by prescription ) or sugar pills ( placebos ) with the new medicine may last longer than Phases I and II ...

  7. Participating in Clinical Trials

    Medline Plus

    Full Text Available skip navigation Help Search home health topics A-Z Videos A-Z about us Customer Support NIH SeniorHealth Built with You in Mind Resize Text: A A A Change Contrast print sign up Share Home > Health topics A-Z > Participating in Clinical Trials: About ...

  8. Clinical Trial Basics (United States)

    ... How Am I Protected? Mark Bowden / iStock Ethical guidelines The goal of clinical research is to develop knowledge that improves human ... data and decide whether the results have medical importance. Results from clinical trials are often published in peer-reviewed scientific ...

  9. Experiments in computing: a survey. (United States)

    Tedre, Matti; Moisseinen, Nella


    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.

  10. Antigravity Acts on Photons (United States)

    Brynjolfsson, Ari


    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.

  11. Impact of efalizumab on patient-reported outcomes in high-need psoriasis patients: results of the international, randomized, placebo-controlled Phase III Clinical Experience Acquired with Raptiva (CLEAR trial [NCT00256139

    Directory of Open Access Journals (Sweden)

    Shumack Stephen


    Full Text Available Abstract Background Chronic psoriasis can negatively affect patients' lives. Assessing the impact of treatment on different aspects of a patient's health-related quality of life (HRQOL is therefore important and relevant in trials of anti-psoriasis agents. The recombinant humanized IgG1 monoclonal antibody efalizumab targets multiple T-cell-dependent steps in the immunopathogenesis of psoriasis. Efalizumab has demonstrated safety and efficacy in several clinical trials, and improves patients' quality of life. Objective: To evaluate the impact of efalizumab on HRQOL and other patient-reported outcomes in patients with moderate to severe plaque psoriasis, including a large cohort of High-Need patients for whom at least 2 other systemic therapies were unsuitable because of lack of efficacy, intolerance, or contraindication. Methods A total of 793 patients were randomized in a 2:1 ratio to receive efalizumab 1 mg/kg/wk (n = 529 or placebo (n = 264 for 12 weeks. The study population included 526 High-Need patients (342 efalizumab, 184 placebo. The treatment was evaluated by patients using the HRQOL assessment tools Short Form-36 (SF-36 and Dermatology Life Quality Index (DLQI. Other patient-reported assessments included the Psoriasis Symptom Assessment (PSA, a visual analog scale (VAS for itching, and the Patient's Global Psoriasis Assessment (PGPA. Results Efalizumab was associated with improvements at Week 12 from baseline in patient-reported outcomes, both in the total study population and in the High-Need cohort. Among all efalizumab-treated patients, the DLQI improved by 5.7 points from baseline to Week 12, relative to an improvement of 2.3 points for placebo patients (P P Conclusion A 12-week course of efalizumab improved HRQOL and other patient-reported outcomes in patients with moderate to severe plaque psoriasis. The benefits of efalizumab therapy in High-Need patients were similar to those observed in the total study population, indicating

  12. Using Acceptance and Commitment Therapy to Increase Self-Compassion: A Randomized Controlled Trial


    Yadavaia, James E.; Hayes, Steven C.; Vilardaga, Roger


    Self-compassion has been shown to be related to several types of psychopathology, including traumatic stress, and has been shown to improve in response to various kinds of interventions. Current conceptualizations of self-compassion fit well with the psychological flexibility model, which underlies acceptance and commitment therapy (ACT). However, there has been no research on ACT interventions specifically aimed at self-compassion. This randomized trial therefore compared a 6-hour ACT-based ...

  13. 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...

  14. Clinical Research and Clinical Trials (United States)

    ... NICHD Publications Data Sharing and Other Resources Research Clinical Trials & Clinical Research Skip sharing on social media links ... health care providers, and researchers. Find NICHD-Supported Clinical Trials Use this link to find a list of ...

  15. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Trials Information A to Z List of Cancer Drugs Complementary & Alternative Medicine (CAM) Questions to Ask about ... Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings & Cancer Adjusting to ...

  16. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Unusual Cancers of Childhood Treatment Childhood Cancer Genomics Study Findings Metastatic Cancer Metastatic Cancer Research Common Cancer ... Trials Insurance Coverage and Clinical Trials How to Work With Your Health Insurance Plan Federal Government Programs ...

  17. HIV/AIDS Clinical Trials (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 ...

  18. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study



    Background Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. Methods A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Results Interviewees described the added value of qualitative research for the...

  19. Can we identify non-stationary dynamics of trial-to-trial variability?

    Directory of Open Access Journals (Sweden)

    Emili Balaguer-Ballester

    Full Text Available Identifying sources of the apparent variability in non-stationary scenarios is a fundamental problem in many biological data analysis settings. For instance, neurophysiological responses to the same task often vary from each repetition of the same experiment (trial to the next. The origin and functional role of this observed variability is one of the fundamental questions in neuroscience. The nature of such trial-to-trial dynamics however remains largely elusive to current data analysis approaches. A range of strategies have been proposed in modalities such as electro-encephalography but gaining a fundamental insight into latent sources of trial-to-trial variability in neural recordings is still a major challenge. In this paper, we present a proof-of-concept study to the analysis of trial-to-trial variability dynamics founded on non-autonomous dynamical systems. At this initial stage, we evaluate the capacity of a simple statistic based on the behaviour of trajectories in classification settings, the trajectory coherence, in order to identify trial-to-trial dynamics. First, we derive the conditions leading to observable changes in datasets generated by a compact dynamical system (the Duffing equation. This canonical system plays the role of a ubiquitous model of non-stationary supervised classification problems. Second, we estimate the coherence of class-trajectories in empirically reconstructed space of system states. We show how this analysis can discern variations attributable to non-autonomous deterministic processes from stochastic fluctuations. The analyses are benchmarked using simulated and two different real datasets which have been shown to exhibit attractor dynamics. As an illustrative example, we focused on the analysis of the rat's frontal cortex ensemble dynamics during a decision-making task. Results suggest that, in line with recent hypotheses, rather than internal noise, it is the deterministic trend which most likely underlies

  20. Long-acting beta(2)-agonists in management of childhood asthma

    DEFF Research Database (Denmark)

    Bisgaard, H


    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....

  1. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

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


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

  2. The Trial of Katherine Harrison. (United States)

    Woodward, Walter W.


    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)

  3. Occasional Reinforced Trials during Extinction Can Slow the Rate of Rapid Reacquisition (United States)

    Bouton, Mark E.; Woods, Amanda M.; Pineno, Oskar


    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…

  4. 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. (United States)

    Wheless, James W; Isojarvi, Jouko; Lee, Deborah; Drummond, Rebecca; Benbadis, Selim R


    Lennox-Gastaut syndrome (LGS) severity varies considerably, so the potential impact of differences in baseline severity on patient outcome following treatment is clinically informative. Here, two surrogate indicators of LGS severity (baseline seizure frequency and vagus nerve stimulation [VNS] use) were used in post hoc analyses of both short- and long-term clobazam trials (Phase III OV-1012 [CONTAIN] and open-label extension [OLE] OV-1004). In CONTAIN, 217 patients comprised the modified, intention-to-treat population. Each baseline seizure-frequency quartile had ~40 patients, and baseline weekly drop-seizure frequency ranges were as follows: clobazam-treated patients (vs. 7% for placebo) in Quartile 1. Five percent of clobazam-treated patients in Quartile 4 (most severe LGS) vs. 0% for placebo achieved 100% reduction in drop seizures. A total of 267 of 306 possible patients entered the OLE (61/68 from a Phase II study and 206/238 from Phase III CONTAIN). Each quartile had ~66 patients, and baseline weekly drop-seizure ranges were as follows: 50% of patients in all 4 quartiles demonstrated ≥ 50% decreases in weekly frequency for drop seizures. More than 12% of patients in Quartile 4 achieved 100% reduction in drop seizures from Month 3 through Year 5. For the VNS analyses in CONTAIN, the least-squares mean decreases in average weekly rate of drop seizures (mITT population) were 52% for VNS patients receiving clobazam vs. -22% for placebo (p clobazam and 26% for placebo (p clobazam-treated patients in the VNS and non-VNS groups demonstrated ≥ 50% decreases in average weekly drop- and total-seizure frequencies, and 11% and 14% in the two groups achieved drop-seizure freedom, respectively. Analyses using baseline seizure frequency and VNS use as surrogates for disease severity showed that clobazam treatment of patients with less severe or severe LGS was equally efficacious.

  5. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Katz, J N; Losina, E; Lohmander, L S


    relating to obsolescence, fidelity of intervention delivery, and adherence and crossover. Assessment and analysis raise questions regarding blinding and clustering of observations. This paper describes methodological problems in the design and conduct of surgical randomized trials and proposes strategies......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 each...... challenge raised in the paper, we propose potential solutions. Enrollment poses challenges in maintaining investigator equipoise, managing conflict of interest and anticipating that patient preferences for specific treatments may reduce enrollment. Intervention design and implementation pose challenges...

  6. The COLOFOL trial

    DEFF Research Database (Denmark)

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


    trial, comparing demographic characteristics between randomized patients and eligible patients not included in the study. MATERIALS AND METHODS: COLOFOL was designed as a pragmatic trial with wide inclusion criteria and few exclusion criteria, in order to obtain a sample reflecting the general patient...... population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24...... 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...

  7. 78 FR 68422 - Patent Trial and Appeal Board (PTAB) Actions (Formerly Board of Patent Appeals and Interferences... (United States)


    ... directed to the attention of Linda Horner, Acting Vice Chief Judge, Patent Trial and Appeal Board, United...-9797; or by email to . Additional information about this collection is...

  8. Gateways to clinical trials. (United States)

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


    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, This issues focuses on the following selection of drugs: 4'-Thio-ara-C, 5-methyltetrahydrofolate; ABT-089, AD-237, AF-37702, alvocidib hydrochloride, apricitabine, armodafinil, atrasentan, AVE-5883, avian influenza vaccine, azimilide hydrochloride; Banoxantrone, BIBF-1120; CD34+ cells, certolizumab pegol, CHIR-258, cilansetron, CoFactor, CX-3543, cystemustine; D-003, dexloxiglumide, DMXB-anabaseine; Ecogramostim, elcometrine, elcometrine/ethinylestradiol, etravirine; Fenretinide, fingolimod hydrochloride, fospropofol disodium; Gaboxadol, gestodene, glutamine; Human insulin, hyaluronic acid; Incyclinide, indacaterol, ispronicline, istradefylline; Labradimil, lamifiban, lapatinib, L-arginine hydrochloride, liposomal cisplatin, liposome encapsulated paclitaxel, LY-517717; Manidipine hydrochloride/delapril hydrochloride, maraviroc, MBP(82-98), MD-0727, MDX-214, melanotan I, MMR vaccine; Nacystelyn, nalfurafine hydrochloride, nibentan, nilotinib, NK-105; OBI-1, oblimersen sodium, olmesartan medoxomil, olmesartan medoxomil/hydrochlorothiazide, oregovomab; Pexelizumab, PG-116800, PG-CPT, PHA-794428, prasugrel; RC-3095, rDNA insulin, RFB4(dsFv)-PE38, rhEndostatin, rhenium Re-186 etidronate, rhGM-CSF, roflumilast, romidepsin; Sarcosine, SGLU1, SGN-40, succinobucol; TAU, teduglutide, telatinib, tesofensine, tipifarnib, tirapazamine, TKA-731, tolvaptan, trabectedin; Vaccimel, vatalanib succinate, velafermin, vildagliptin, vinflunine; XP-19986; YM-155.

  9. Asymptomatic carotid stenosis: What we can learn from the next generation of randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Mark N Rubin


    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.

  10. A guide to clinical trials for cancer (United States)

    ... this page: // A guide to clinical trials for cancer To use ... trial and where to find one. What is a Clinical Trial for Cancer? Clinical trials for cancer ...

  11. Double acting bit holder (United States)

    Morrell, Roger J.; Larson, David A.; Ruzzi, Peter L.


    A double acting bit holder that permits bits held in it to be resharpened during cutting action to increase energy efficiency by reducing the amount of small chips produced. The holder consist of: a stationary base portion capable of being fixed to a cutter head of an excavation machine and having an integral extension therefrom with a bore hole therethrough to accommodate a pin shaft; a movable portion coextensive with the base having a pin shaft integrally extending therefrom that is insertable in the bore hole of the base member to permit the moveable portion to rotate about the axis of the pin shaft; a recess in the movable portion of the holder to accommodate a shank of a bit; and a biased spring disposed in adjoining openings in the base and moveable portions of the holder to permit the moveable portion to pivot around the pin shaft during cutting action of a bit fixed in a turret to allow front, mid and back positions of the bit during cutting to lessen creation of small chip amounts and resharpen the bit during excavation use.

  12. An Act of Colonization

    DEFF Research Database (Denmark)

    Rasmussen, Anders Bo

    When Gideon Welles, U.S. Secretary of the Navy, sat down to write his diary entry on September 26, 1862, his thoughts turned once more to colonization. President Lincoln was an ardent proponent of colonization, “the government-promoted settlement of black Americans in Africa or some other location......” and based on the recurring cabinet discussions, Welles understood that “Great Britain, Denmark and perhaps other powers would take them [the black population].” Since at least 1860, Denmark had encouraged the American government to send the “quite uncivilized (…) Africans liberated” from slave ships to St...... and the United States signed an act on July 19, 1862, wherein the U.S. Navy agreed to unload “all negroes, mulattoes, or persons of color, delivered from on board vessels seized in the prosecution of the slave trade.” Yet, despite the two countries’ mutual interests in employing “laborers of African Extraction...

  13. [Clinical single case study (n-of-1 trial)]. (United States)

    Speich, R


    We conducted a single case (N-of-1) randomized trial in two patients. In the first case with bronchiolitis obliterans after lung transplantation a beneficial effect of inhaled steroids could be documented. The second patient suffered from symptoms compatible with HIV-associated M. Addison improving after cortisone, but the adrenocortical function was normal. Because the patient required the cortison treatment to be continued, we performed a n-of-1 trial which demonstrated the inefficacy of cortisone. This experience underscores the feasibility and usefulness of N-of-1 randomized clinical trials in medical practice.

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

    DEFF Research Database (Denmark)

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


    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....

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

    Directory of Open Access Journals (Sweden)

    Thomas eFitzGerald, MD


    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.

  16. SMi's Conducting Clinical Trials in Europe. (United States)

    Jago, Charlotte


    The Conducting Clinical Trials in Europe meeting, held in London, included topics covering new developments in the field of clinical trials and recommendations on how to best conduct a trial. This conference report highlights selected presentations on the state of affairs of trials in Europe, conducting trials in emerging markets, strategies for improving trials, trial design options, peri-approval and pediatric trials, and the role of key players, such as physicians. Company perspectives from Pfizer Inc and Nycomed are also included.

  17. 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


    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...

  18. Advanced Communications Technology Satellite (ACTS) (United States)

    Olmstead, Dean A.; Schertler, Ronald J.

    The benefits that will be offered by the NASA-sponsored communication spacecraft ACTS which is scheduled for launch in 1992 are described together with examples of demonstrations on proposed data, video, and voice applications supported by the advanced ACTS technologies. Compared to existing satellite service, the ACTS will provide lower cost, better service, greater convenience, and improved service reliability of telecommunications to customers around the world. In addition, the pioneering ACTS technology will provide many capabilities qualitatively different from those of current satellite systems, such as on-demand assignment, frequency reuse, and the flexible targeting of spot beams directly to the very-small-aperture terminals at customer premises.

  19. [Euthanasia and medical act]. (United States)


    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.

  20. 75 FR 63703 - Privacy Act of 1974; Privacy Act Regulation (United States)


    ... 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...

  1. Metacognition of Working Memory Performance: Trial-by-Trial Subjective Effects from a New Paradigm. (United States)

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


    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.

  2. Isolated effects of number of acquisition trials on extinction of rat conditioned approach behavior. (United States)

    Gottlieb, Daniel A; Prince, Emily B


    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.

  3. Research progress in the development of direct acting antiviral agents for hepatitis C and the anti-viral resistance

    Directory of Open Access Journals (Sweden)

    Song YANG


    Full Text Available Recently,directly acting antiviral agents against hepatitic C virus with different mechanisms have been developed and put into clinical trials.Especially,results of phase Ⅲ clinical trials of Boceprevir and Telaprevir have been published,and these two agents are to be approved for marketing in recent years.Also much attention has been paid on anti-viral resistance against direct acting antiviral agents.Great progresses have been made in field of direct acting antiviral agents against hepatitic C virus.Domestic studies in this area should take characteristics of virus and host of Chinese chronic hepatitis C into consideration.

  4. Gateways to clinical trials. (United States)

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


    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. 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

  5. Assertive Community Treatment For People With Alcohol Dependence: A Pilot Randomized Controlled Trial (United States)

    Gilburt, Helen; Burns, Tom; Copello, Alex; Crawford, Michael; Day, Ed; Deluca, Paolo; Godfrey, Christine; Parrott, Steve; Rose, Abigail; Sinclair, Julia; Coulton, Simon


    Abstract Aims A pilot randomized controlled trial (RCT) to assess the feasibility and potential efficacy of assertive community treatment (ACT) in adults with alcohol dependence. Methods Single blind, individually randomized, pilot RCT of 12 months of ACT plus treatment as usual (TAU) versus TAU alone in adults (age 18+ years) with alcohol dependence and a history of previous unsuccessful alcohol treatment attending specialist community alcohol treatment services. ACT aimed to actively engage participants for 12 months with assertive, regular, minimum weekly contact. ACT was combined with TAU. TAU comprised access to the full range of services provided by the community teams. Primary outcome is mean drinks per drinking day and percent days abstinent at 12 months follow up. Analysis of covariance was conducted using 80% confidence intervals, appropriate in the context of a pilot trial. Results A total of 94 participants were randomized, 45 in ACT and 49 in TAU. Follow-up was achieved with 98 and 88%, respectively at 12 months. Those in ACT had better treatment engagement, and were more often seen in their homes or local community than TAU participants. At 12 months the ACT group had more problems related to drinking and lower quality of life than TAU but no differences in drinking measures. The ACT group had a higher percentage of days abstinent but lower quality of life at 6 months. The ACT group had less unplanned healthcare use than TAU. Conclusions An trial of ACT was feasible to implement in an alcohol dependent treatment population. Trial registration ISRCTN22775534 PMID:27940571

  6. The ONTARGET trial programme

    DEFF Research Database (Denmark)

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


    The ONTARGET trial programme tested the effects of the angiotensin AT1 receptor blocker (ARB), telmisartan, alone or in combination with the angiotensin converting enzyme (ACE) inhibitor, ramipril, in more than 25.000 patients at high cardiovascular risk including diabetes on a combined endpoint ....... Telmisartan thus proved to be the first and so far the only representative of the ARB class that can be used as an alternative to the "gold standard" ACE-inhibitor, ramipril, in patients at high cardiovascular risk with or without hypertension. © 2009 Bentham Science Publishers Ltd....

  7. The CHANGE trial

    DEFF Research Database (Denmark)

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


    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...

  8. Prehypertension - Time to Act

    Directory of Open Access Journals (Sweden)

    Preeti Gupta


    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.

  9. 76 FR 59073 - Privacy Act (United States)


    ...: Consistent with the Privacy Act (PA), the Central Intelligence Agency (CIA) has undertaken and completed a... clearly reflect the current CIA organizational structure and policies and practices, and to eliminate... Act (PA), the CIA has undertaken and completed a review of its public PA regulations. As a result...

  10. Choosing a control intervention for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Djulbegovic Benjamin


    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. Acting to let someone die. (United States)

    McGee, Andrew


    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.

  12. Hamlet and psychoanalytic experience. (United States)

    Schwaber, Paul


    Hamlet draws us into its rendered world, enabling us to experience it with depth, awareness, and resonance, in a mode we recognize as aesthetic. By way of Shakespeare's play--primarily the first act--and a detailed case study, aesthetic and psychoanalytic experience are compared, to suggest that, for our own analytic discourse, we revalue Freud's unease that his case studies read like short stories.

  13. [Ethical aspects of randomized clinical trials]. (United States)

    Bartoli, E; Sorrentino, D; Trevisi, A


    Randomized clinical trials represent the final, essential link between basic medical research and human health. However, their conduction presents very complex ethical problems, since the patient is the actual target of the experiment. Proper randomization, informed consent, and preliminary disclosure of results create deep ethical conflicts between the role of caretaker and that of impartial observer, both played by the same doctor. The dilemma reproduces the conflict between two different ethics. One is based on the inalienable individual rights stemming from the concept of man as an end in himself and not a means to an end. The other, derived from utilitarian philosophies, is based on the benefit for society as a whole. If we agree that randomized clinical trials represent the best method to test the validity of a new treatment, there is no easy solution. The dilemma could be solved by separating the role of the family doctor, committed to the best treatment possible for his patient, from the role of the scientist, committed to the progress of science and humanity. The former is involved in the treatment of individual patients, the latter in clinical and scientific experiments of a therapeutic nature. The patient may trade his rights to the best possible cure for the safety and the efficiency guaranteed by the scientific institution conducting the trial. Trials on relevant issues--expected to produce important results and impeccably designed scientifically--could be endowed with the ethics of science per se and this could be considered equivalent to the individual rights waived by the patient.

  14. What Value Can Qualitative Research Add to Quantitative Research Design? An Example From an Adolescent Idiopathic Scoliosis Trial Feasibility Study. (United States)

    Toye, Francine; Williamson, Esther; Williams, Mark A; Fairbank, Jeremy; Lamb, Sarah E


    Using an example of qualitative research embedded in a non-surgical feasibility trial, we explore the benefits of including qualitative research in trial design and reflect on epistemological challenges. We interviewed 18 trial participants and used methods of Interpretive Phenomenological Analysis. Our findings demonstrate that qualitative research can make a valuable contribution by allowing trial stakeholders to see things from alternative perspectives. Specifically, it can help to make specific recommendations for improved trial design, generate questions which contextualize findings, and also explore disease experience beyond the trial. To make the most out of qualitative research embedded in quantitative design it would be useful to (a) agree specific qualitative study aims that underpin research design, (b) understand the impact of differences in epistemological truth claims, (c) provide clear thematic interpretations for trial researchers to utilize, and (d) include qualitative findings that explore experience beyond the trial setting within the impact plan.

  15. 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

  16. Practical trials in medical education

    DEFF Research Database (Denmark)

    Tolsgaard, Martin G; Kulasegaram, Kulamakan M; Ringsted, Charlotte


    controlled settings generalise to the real-life education context. One way of bridging this gap is applying the concept of practical trials in medical education. In this paper we elaborate on characteristics of practical trials and based on examples from medical education we discuss the challenges...... administration, quality of care, patient outcomes and cost. CONCLUSIONS: Practical trials in medical education may contribute to bridge the gap between education theory and practice and aid decision makers in making evidence-based choices and priorities. Conducting practical trials is not without challenges...

  17. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Phases of Clinical Trials Cancer Treatment Types of Cancer Treatment Surgery Radiation Therapy Chemotherapy Immunotherapy Targeted Therapy Hormone Therapy Stem Cell Transplant Precision ...

  18. Short-Acting Beta-Agonist Research: A Perspective

    Directory of Open Access Journals (Sweden)

    Malcolm R Sears


    Full Text Available Asthma mortality increased sharply in New Zealand in 1977, prompting a national investigation into circumstances of asthma deaths. Subsequent observations of improved asthma control in subjects withdrawn from regular beta2-agonist treatment raised the question of whether asthma severity and, therefore, mortality could relate to frequent beta-agonist use. A randomized controlled trial of regular inhaled fenoterol versus as-needed bronchodilator use showed worsened asthma control during regular treatment despite concomitant use of inhaled corticosteroids. Assessment of these findings led to delay in the publishing of the American Asthma Guidelines, which were modified to suggest caution in using beta2-agonist treatments. Simultaneously, case control studies in New Zealand suggested that prescription of fenoterol was a substantial risk factor for asthma mortality. The causal association was hotly debated, but increasing evidence pointed to an adverse effect of fenoterol on asthma severity and, hence, mortality. This was supported by dramatic decreases in both morbidity and mortality when fenoterol was effectively withdrawn from use in New Zealand. The link between worsening asthma morbidity and mortality, and the use of potent short-acting beta2-agonists fulfills the Bradford Hill criteria for attributing causality. Application of evidence from randomized, controlled trials of short-acting beta-agonist use has led to a major shift in therapy in asthma to the recommendation of as-needed use only of short-acting beta-agonists and decreased patient reliance on regular bronchodilator therapy.

  19. Conducting qualitative research within Clinical Trials Units: avoiding potential pitfalls. (United States)

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


    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.

  20. Design and implementation of clinical trials in rehabilitation research. (United States)

    Hart, Tessa; Bagiella, Emilia


    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.

  1. Facilitating and inhibiting effects of priming and selection criteria in a sequence of dichotic listening trials. (United States)

    Saetrevik, Bjørn


    Competing models of attention make different predictions of how priming from recent stimulus processing could interact with intended selection. The present experiment examined the interaction between exogenous attention and endogenous priming across trial sequences. A sound cue directed attention to left, right or both sides before a dichotic syllable pair was presented. Participants were asked to report one syllable from each trial. Results showed that responses were slower on trials where one of the presented syllables had also been presented on the previous trial. Within these trials, the repeated syllable was selected less frequently, and the responses doing so were slower. Examined according to response choice on the preceding trial, syllables that had been ignored on the preceding trial tended to be ignored on the current trial (negative priming), while syllables that had been selected on the preceding trial tended to be selected on the current trial (positive priming). Responses that followed these selection biases were faster than responses that did not. Response selection was also influenced by the attention direction cue for the current trial, but not by the cue presented on the preceding trial. The results support an attentional model where traces from the preceding processing are retained, and current selection is biased to minimize cognitive conflict between recent and current processing. Negative priming appears to be due to after-effects of preceding processing, independently of the intentions behind that processing. The study accounts for positive and negative priming of dichotic listening sequences within an established, computationally viable biased competition framework.

  2. Understanding the impact of subsidizing artemisinin-based combination therapies (ACTs in the retail sector--results from focus group discussions in rural Kenya.

    Directory of Open Access Journals (Sweden)

    Sarah V Kedenge

    Full Text Available BACKGROUND: There is considerable interest in the potential of private sector subsidies to increase availability and affordability of artemisinin-based combination therapies (ACTs for malaria treatment. A cluster randomized trial of such subsidies was conducted in 3 districts in Kenya, comprising provision of subsidized packs of paediatric ACT to retail outlets, training of retail staff, and community awareness activities. The results demonstrated a substantial increase in ACT availability and coverage, though patient counselling and adherence were suboptimal. We conducted a qualitative study in order to understand why these successes and limitations occurred. METHODOLOGY/PRINCIPAL FINDINGS: Eighteen focus group discussions were conducted, 9 with retailers and 9 with caregivers, to document experiences with the intervention. Respondents were positive about intervention components, praising the focused retailer training, affordable pricing, strong promotional activities, dispensing job aids, and consumer friendly packaging, which are likely to have contributed to the positive access and coverage outcomes observed. However, many retailers still did not stock ACT, due to insufficient supplies, lack of capital and staff turnover. Advice to caregivers was poor due to insufficient time, and poor recall of instructions. Adherence by caregivers to dosing guidelines was sub-optimal, because of a wish to save tablets for other episodes, doses being required at night, stopping treatment when the child felt better, and the number and bitter taste of the tablets. Caregivers used a number of strategies to obtain paediatric ACT for older age groups. CONCLUSIONS/SIGNIFICANCE: This study has highlighted that important components of a successful ACT subsidy intervention are regular retailer training, affordable pricing, a reliable supply chain and community mobilization emphasizing patient adherence and when to seek further care.

  3. Gateways to clinical trials. (United States)

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


    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, 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

  4. Trial encoding algorithms ensemble. (United States)

    Cheng, Lipin Bill; Yeh, Ren Jye


    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.

  5. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A B; Smith, G;


    BACKGROUND: Many reflux patients remain symptomatic on a standard dose of proton pump inhibitor (PPI). Alginates decrease the number of reflux events by forming a raft on top of the stomach content and thus offer a supplemental mechanism of action to acid suppression. AIM: To assess the efficacy...... 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......: In patients with residual reflux symptoms despite PPI treatment, adding an alginate offers additional decrease in the burden of reflux symptoms (EudraCT/IND Number: 2011-005486-21)....

  6. The CYTONOX trial

    DEFF Research Database (Denmark)

    Gade, Christina; Mikus, Gerd; Christensen, Hanne Rolighed;


    INTRODUCTION: In Denmark, it is estimated that 3-5% of children are obese. Obesity is associated with pathophysiological alterations that may lead to alterations in the pharmacokinetics of drugs. In adults, obesity was found to influence important drug-metabolising enzyme pathways. The impact......, CYP2E1 and CYP1A2 in obese and non-obese children. The results are expected to be used in the future as a basis for drug dosing recommendations in obese children. FUNDING: The study was funded by the Danish Regions' "Medicinpuljen". The funder had no role in study design, data collection and analysis...... of obesity-related alterations on drug metabolism and its consequences for drug dosing remains largely unknown in both children and adults. An altered drug metabolism may contribute significantly to therapeutic failure or toxicity. The aim of this trial is to investigate the in vivo activity of CYP3A4, CYP2E...

  7. LTDNA Evidence on Trial (United States)

    Roberts, Paul


    Adopting the interpretative/hermeneutical method typical of much legal scholarship, this article considers two sets of issues pertaining to LTDNA profiles as evidence in criminal proceedings. The section titled Expert Evidence as Forensic Epistemic Warrant addresses some rather large questions about the epistemic status and probative value of expert testimony in general. It sketches a theoretical model of expert evidence, highlighting five essential criteria: (1) expert competence; (2) disciplinary domain; (3) methodological validity; (4) materiality; and (5) legal admissibility. This generic model of expert authority, highlighting law's fundamentally normative character, applies to all modern forms of criminal adjudication, across Europe and farther afield. The section titled LTDNA Evidence in UK Criminal Trials then examines English and Northern Irish courts' attempts to get to grips with LTDNA evidence in recent cases. Better appreciating the ways in which UK courts have addressed the challenges of LTDNA evidence may offer some insights into parallel developments in other legal systems. Appellate court rulings follow a predictable judicial logic, which might usefully be studied and reflected upon by any forensic scientist or statistician seeking to operate effectively in criminal proceedings. Whilst each legal jurisdiction has its own unique blend of jurisprudence, institutions, cultures and historical traditions, there is considerable scope for comparative analysis and cross-jurisdictional borrowing and instruction. In the spirit of promoting more nuanced and sophisticated international interdisciplinary dialogue, this article examines UK judicial approaches to LTDNA evidence and begins to elucidate their underlying institutional logic. Legal argument and broader policy debates are not confined to considerations of scientific validity, contamination risks and evidential integrity, or associated judgments of legal admissibility or exclusion. They also crucially

  8. Treatment Resistant Depression with Loss of Antidepressant Response: Rapid—Acting Antidepressant Action of Dextromethorphan, A Possible Treatment Bridging Molecule (United States)

    Lauterbach, Edward C.


    Dextromethorphan (DM) may have ketamine—like rapid—acting, treatment—resistant, and conventional antidepressant effects.1,2 This reports our initial experience with DM in unipolar Major Depressive Disorder (MDD). A patient with treatment—resistant MDD (failing adequate trials of citalopram and vortioxetine) with loss of antidepressant response (to fluoxetine and bupropion) twice experienced a rapid—acting antidepressant effect within 48 hours of DM administration and lasting 7 days, sustained up to 20 days with daily administration, then gradually developing labile loss of antidepressant response over the ensuing 7 days. Upon full relapse in DSM-5 MDD while taking 600 mg/day of the strong CYP2D6 inhibitor bupropion XL, a 300 mg oral loading dose of DM was given, followed by 60 mg po bid after an additional dose—finding period, without side effects. DM exhibited a ketamine—like rapid—acting antidepressant effect, thought to be mediated by mTOR activation (related to NMDA PCP site antagonism, sigma-1 and beta adrenergic receptor stimulation) and 5HTT inhibition, resulting in AMPA receptor trafficking, and dendritogenesis, spinogenesis, synaptogenesis, and increased neuronal survival (related to NMDA antagonism and sigma-1 and mTOR signaling). This report appears to be the first report of a rapid—acting effect in unipolar MDD and adds to antidepressant effects observed in the retrospective chart review of 77 patients with Bipolar II Disorder (Kelly and Lieberman 2014). If replicated, there is some reason to think that the administration of other agents with DM, such as lithium or D-cycloserine, might prolong the duration of the rapid-antidepressant effect. PMID:27738380

  9. Unique perception of clinical trials by Korean cancer patients

    Directory of Open Access Journals (Sweden)

    Lee Su Jin


    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.

  10. Endangered Species Act Critical Habitat (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...

  11. Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations (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...

  12. Randomized clinical trials in HEPATOLOGY

    DEFF Research Database (Denmark)

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


    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...

  13. Defendants' Rights in Criminal Trials. (United States)

    Martin, Ralph C., II; Keeley, Elizabeth


    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)


    Directory of Open Access Journals (Sweden)

    Stephan S Terblanche


    Full Text Available In this contribution a number of procedural issues related to the sentencing of child offenders and emanating from the Child Justice Act 75 of 2008 are considered in some detail. As a general rule, the Act requires pre-sentence reports to be obtained from probation officers before sentencing any child offender, with only a limited number of exceptions. The article argues that the peremptory nature of the Act means that a probation report is always required, even if reports by other experts are also available. The exceptions are limited to instances other than those where the child offender is sentenced to any form of imprisonment or to residence in a care centre. The article addresses the question of whether or not the reference to imprisonment includes alternative imprisonment which is imposed only as an alternative to a fine. It suggests that alternative imprisonment should, generally, not be imposed on child offenders. When an exception is not prevented because of the sentence, a pre-sentence report may be dispensed with only when the offence is a schedule-1 offence (the least serious class of offences or when obtaining a report would prejudice the child. It is argued that these exceptions are likely to occur rather rarely. A final aspect of the Act’s provisions on pre-sentence reports is the requirement that reasons be given for a departure from the recommendations in a pre-sentence report. This requirement merely confirms the status quo.The Act permits the prosecutor to provide the court with a victim impact statement. Such a statement is defined in the Act. It is a sworn statement by a victim or someone authorised by the victim explaining the consequences to the victim of the commission of the crime. The article also addresses the issue of whether or not the child justice court might mero motu obtain a victim impact statement when the prosecution does not do so.Finally, the article addresses appeals against and reviews of the trial

  15. 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


    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.

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

    Institute of Scientific and Technical Information of China (English)


    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.

  17. 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)

    DEFF Research Database (Denmark)

    Kristensen, Peter Lommer; Pedersen-Bjergaard, Uirik; Beck-Nielsen, Henning


    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....

  18. Effect of trial-to-trial variability on optimal event-related fMRI design: Implications for Beta-series correlation and multi-voxel pattern analysis. (United States)

    Abdulrahman, Hunar; Henson, Richard N


    Functional magnetic resonance imaging (fMRI) studies typically employ rapid, event-related designs for behavioral reasons and for reasons associated with statistical efficiency. Efficiency is calculated from the precision of the parameters (Betas) estimated from a General Linear Model (GLM) in which trial onsets are convolved with a Hemodynamic Response Function (HRF). However, previous calculations of efficiency have ignored likely variability in the neural response from trial to trial, for example due to attentional fluctuations, or different stimuli across trials. Here we compare three GLMs in their efficiency for estimating average and individual Betas across trials as a function of trial variability, scan noise and Stimulus Onset Asynchrony (SOA): "Least Squares All" (LSA), "Least Squares Separate" (LSS) and "Least Squares Unitary" (LSU). Estimation of responses to individual trials in particular is important for both functional connectivity using "Beta-series correlation" and "multi-voxel pattern analysis" (MVPA). Our simulations show that the ratio of trial-to-trial variability to scan noise impacts both the optimal SOA and optimal GLM, especially for short SOAsdesign of experiments using Beta-series regression and MVPA, but also statistical parametric mapping studies that seek only efficient estimation of the mean response across trials.

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


    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.

  20. 7 CFR 33.1 - Act. (United States)


    ... 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...

  1. Clinical Trials | Division of Cancer Prevention (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. |

  2. HIV/AIDS Clinical Trials Fact Sheet (United States)

    ... and effective in people. What is an HIV/AIDS clinical trial? HIV/AIDS clinical trials help researchers ... to HIV Can anyone participate in an HIV/AIDS clinical trial? It depends on the study. Some ...

  3. Ethical pitfalls in neonatal comparative effectiveness trials. (United States)

    Modi, Neena


    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

  4. 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


    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

  5. Advanced Communications Technology Satellite (ACTS). Phase 1: Industrial/academic experimenters (United States)

    Maisel, James E.; Nowlin, Robert W.


    This report presents the work done at Arizona State University under the ACTS Experimenters Program. The main thrust of the Program was to develop experiments to test, evaluate, and prove the commercial worthiness of the ACTS satellite which is scheduled for launch in 1993. To accomplish this goal, meetings were held with various governmental, industrial, and academic units to discuss the ACTS satellite and its technology and possible experiments that would generate industrial interest and support for ASU's efforts. Several local industries generated several experiments of their own. The investigators submitted several experiments of educational, medical, commercial, and technical value and interest. The disposition of these experimental proposals is discussed in this report.

  6. Social media in clinical trials. (United States)

    Thompson, Michael A


    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.

  7. The Mock Trial: A Dynamic Exercise for Thinking Critically about Management Theories, Topics, and Practices (United States)

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


    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…

  8. The Dynamo Clinical Trial (United States)

    Ayres, Thomas R.


    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.)

  9. Challenges in coding adverse events in clinical trials

    DEFF Research Database (Denmark)

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


    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...

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

    DEFF Research Database (Denmark)

    Gluud, C; Sørensen, T I


    , 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...

  11. Franklin, Lavoisier, and Mesmer: origin of the controlled clinical trial. (United States)

    Herr, Harry W


    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.

  12. Trial analytics--a tool for clinical trial management. (United States)

    Bose, Anindya; Das, Suman


    Prolonged timelines and large expenses associated with clinical trials have prompted a new focus on improving the operational efficiency of clinical trials by use of Clinical Trial Management Systems (CTMS) in order to improve managerial control in trial conduct. However, current CTMS systems are not able to meet the expectations due to various shortcomings like inability of timely reporting and trend visualization within/beyond an organization. To overcome these shortcomings of CTMS, clinical researchers can apply a business intelligence (BI) framework to create Clinical Research Intelligence (CLRI) for optimization of data collection and analytics. This paper proposes the usage of an innovative and collaborative visualization tool (CTA) as CTMS "add-on" to help overwhelm these deficiencies of traditional CTMS, with suitable examples.

  13. Acute Stroke | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available n(s) being investigated Acute Stroke MedDRA Classification E.1.3Condition being s... General Information on the Trial E.1 Medical condition or disease under investigation E.1.1Medical conditio

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

    Directory of Open Access Journals (Sweden)

    Kemal Sinan Özmen


    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.

  15. Microcredit on Trial

    Institute of Scientific and Technical Information of China (English)


    To control the risks of China's newborn microcredit companies, banking regulatory departments should enact supervisory measures as soon as possible For Lei Jinkui, the biggest fear for the future is a lack of experience and capital. The board chairman of Rishengchang Co., a microcredit company in Pingyao County in Shanxi Province, Lei said his company limits the number of employees to

  16. Surgical experimentation and clinical trials: differences and related ethical problems


    Carlo Petrini


    Surgical techniques are not introduced into clinical practice as the result of randomised clinical trials (RCT), but usually through the gradual evolution of existing techniques or, more rarely, through audacious departures from the norm that are decided by a surgical team on the basis of experience. Sham surgery is held by some to be not only an ethically acceptable procedure but also a perfectly fit and proper one, as it could endow surgical experiments with the strict methodological and st...

  17. Act 7 Ask for Commitment

    Institute of Scientific and Technical Information of China (English)

    Duane Sparks from KMG


    <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

  18. The Problem of Agency; How Humans Act, How Machines Act

    DEFF Research Database (Denmark)

    Rose, Jeremy; Jones, M.; Truex, D.


    A long-standing debate in the IS literature concerns the relationship between technology and organization. Is it technology that acts on organizations, or humans that determine how technology is used? Proposals for a middle way between the extremes of technological and social determinism have been...

  19. ATLAS Canada lightpath data transfer trial

    CERN Document Server

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


    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).

  20. Advanced Communications Technology Satellite (ACTS) (United States)

    Gedney, Richard T.; Schertler, Ronald J.


    The NASA Advanced Communications Technology Satellite (ACTS) was conceived to help maintain U.S. leadership in the world's communications-satellite market. This experimental satellite is expected to be launched by NASA in 1992 and to furnish the technology necessary for establishing very small aperture terminal digital networks which provide on-demand full-mesh connectivity, and 1.544-MBPS services with only a single hop. Utilizing on-board switching and processing, each individual voice or data circuit can be separately routed to any location in the network. This paper provides an overview of the ACTS and discusses the value of the technology for future communications systems.

  1. Ethnography, fidelity, and the evidence that anthropology adds: supplementing the fidelity process in a clinical trial of supported employment. (United States)

    Smith-Morris, Carolyn; Lopez, Gilberto; Ottomanelli, Lisa; Goetz, Lance; Dixon-Lawson, Kimberly


    This discussion considers the role and findings of ethnographic research within a clinical trial of supported employment for veterans with spinal cord injury. Contributing to qualitative evaluation research and to debates over anthropological evidence vis-à-vis clinical trials, we demonstrate how enactors of a randomized controlled trial can simultaneously attend to both the trial's evidentiary and procedural requirements and to the lived experiences and needs of patients and clinicians. Three major findings are described: (1) contextual information essential to fidelity efforts within the trial; (2) the role of human interrelationships and idiosyncratic networks in the trial's success; and (3) a mapping of the power and authority structures relevant to the staff's ability to perform the protocol. We emphasize strengths of anthropological ethnography in clinical trials that include the provision of complementary, qualitative data, the capture of otherwise unmeasured parts of the trial, and the realization of important information for the translation of the clinical findings into new settings.

  2. Choice in the repeated-gambles experiment. (United States)

    Silberberg, A; Murray, P; Christensen, J; Asano, T


    Humans chose 10 times between two roulette wheels projected on a monitor. During the first trial, the left wheel provided a hypothetical $100 with p = .94, and the right wheel provided $250 with p = .39. A titration procedure adjusted the probability of a $250 win across trials to permit estimation of an indifference point between alternatives. In Experiment 1, intertrial-interval duration (25 vs. 90 s) and whether sessions began with an intertrial interval or a trial were varied in a 2 x 2 design in this risky-choice procedure. Risk aversion (preference for the $100 wheel) increased with intertrial interval but was unaffected by whether sessions began with a trial or an intertrial interval. In Experiment 2, all sessions began with a trial, and subjects were informed that the experiment ended after 10 trials. Intertrial-interval duration had no effect on choice. In Experiment 3, intertrial-interval duration and whether subjects were given $10 or $10,000 before beginning were varied among four groups in a 2 x 2 design. In all other ways, the procedure was unchanged from Experiment 2. Intertrial interval had no effect on choice, but the $10,000 groups showed less risk aversion than the $10 groups. These results can be explained more readily in terms of Kahneman and Tversky's (1984) notion of "framing of the prospect" than in terms of Rachlin, Logue, Gibbon, and Frankel's (1986) behavioral account of risky choice.

  3. LTDNA Evidence on Trial

    Directory of Open Access Journals (Sweden)

    Paul Roberts


    factfinders in criminal trials.

  4. 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


    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)

  5. Publication of clinical trials supporting successful new drug applications: a literature analysis.

    Directory of Open Access Journals (Sweden)

    Kirby Lee


    proportional models for all trials and the subset of pivotal trials. CONCLUSIONS: Over half of all supporting trials for FDA-approved drugs remained unpublished >/= 5 y after approval. Pivotal trials and trials with statistically significant results and larger sample sizes are more likely to be published. Selective reporting of trial results exists for commonly marketed drugs. Our data provide a baseline for evaluating publication bias as the new FDA Amendments Act comes into force mandating basic results reporting of clinical trials.

  6. The quality of registration of clinical trials: still a problem.

    Directory of Open Access Journals (Sweden)

    Roderik F Viergever

    Full Text Available INTRODUCTION: The benefits of clinical trials registration include improved transparency on clinical trials for healthcare workers and patients, increased accountability of trialists, the potential to address publication bias and selective reporting, and possibilities for research collaboration and prioritization. However, poor quality of information in registered records of trials has been found to undermine these benefits in the past. Trialists' increasing experience with trial registration and recent developments in registration systems may have positively affected data quality. This study was conducted to investigate whether the quality of registration has improved. METHODS: We repeated a study from 2009, using the same methods and the same research team. A random sample of 400 records of clinical trials that were registered between 01/01/2012 and 01/01/2013 was taken from the International Clinical Trials Registry Platform (ICTRP and assessed for the quality of information on 1 contact details, 2 interventions and 3 primary outcomes. Results were compared to the equivalent assessments from our previous study. RESULTS: There was a small and not statistically significant increase from 81.0% to 85.5% in the percentage of records that provided a name of a contact person. There was a significant increase from 68.7% to 74.9% in the number of records that provided either an email address or a telephone number. There was a significant increase from 44.2% to 51.9% in the number of intervention arms that were complete in registering intervention specifics. There was a significant increase from 38.2% to 57.6% in the number of primary outcomes that were specific measures with a meaningful timeframe. Approximately half of all trials continued to be retrospectively registered. DISCUSSION: There have been small but significant improvements in the quality of registration since 2009. Important problems with quality remain and continue to constitute an

  7. Unfulfilled translation opportunities in industry sponsored clinical trials. (United States)

    Smed, Marie; Getz, Kenneth A


    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.

  8. National Lung Screening Trial (NLST) (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.

  9. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Cancer Research and Discovery Stories of Discovery R&D Resources Conducting Clinical Trials Statistical Tools and Data ... about some of NCI's major research initiatives R&D Resources Tools and data sets for researchers Research ...

  10. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Bladder Cancer Breast Cancer Colorectal Cancer Kidney (Renal Cell) Cancer Leukemia Liver Lung Cancer Lymphoma Pancreatic Cancer ... Therapy Chemotherapy Immunotherapy Targeted Therapy Hormone Therapy Stem Cell Transplant Precision Medicine Side Effects Clinical Trials Information ...

  11. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Resources Conducting Clinical Trials Statistical Tools and Data Terminology Resources NCI Data Catalog Cryo-EM NCI's Role ... Report (RPPR) Grant Closeout Grant Resources NCI Grants Management Legal Requirements NCI Grant Policies Grants Management Contacts ...

  12. What Are Clinical Trial Phases? (United States)

    ... Resources Conducting Clinical Trials Statistical Tools and Data Terminology Resources NCI Data Catalog Cryo-EM NCI's Role ... Report (RPPR) Grant Closeout Grant Resources NCI Grants Management Legal Requirements NCI Grant Policies Grants Management Contacts ...

  13. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Resources Conducting Clinical Trials Statistical Tools and Data Terminology Resources NCI Data Catalog Cryo-EM NCI's Role ... Contacts Other Funding Find NCI funding for small business innovation, technology transfer, and contracts Training Cancer Training ...

  14. 77 FR 56815 - Privacy Act of 1974; System of Records (United States)


    ... active service; Public Law 105-368, Veterans Benefits Enhancement Act of 1998; Public Law 95-202, GI Bill..., and questionnaire type data relating to non-service member's education, work experience, motivation... and other submissions from members of the public is to make these submissions available for...

  15. The Equal Pay Act: The First 30 Years. (United States)

    Crampton, Suzanne M.; Hodge, John W.; Mishra, Jitendra M.


    Analysis by decade of the effects of the Equal Pay Act of 1963 shows that women's earnings relative to men's increased by 10 cents from 1960-1990. Black and Hispanic women's earnings lagged further behind. More education and experience did not help women narrow the gap. (SK)

  16. 75 FR 22433 - Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978 (Pub. L. 95-541) (United States)


    ...-541), as amended by the Antarctic Science, Tourism and Conservation Act of 1996, has developed..., experience and physiology on individual foraging efficiency and breeding performance, and develop...

  17. Challenges and guidelines for clinical trial of herbal drugs

    Directory of Open Access Journals (Sweden)

    Abida Parveen


    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

  18. 78 FR 46256 - Privacy Act (United States)


    ... 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...

  19. The Iran Sanctions Act (ISA) (United States)


    Petrobras (Brazil) $34 million ? Oct. 2004 Yadavaran (oil). Finalized December 9, 2007 Sinopec (China) $2 billion 185,000 bpd (by 2011) June...2006 Gamsar block (oil) Sinopec (China) $20 million ? Sept. 2006 Khorramabad block (oil) Norsk Hydro (Norway) $49 million ? The Iran Sanctions Act

  20. Acting against one's best judgement

    NARCIS (Netherlands)

    Peijnenburg, Adriana Johanna Maria


    Handelen tegen beter weten in (Acting Against One’s Best Judgment) heeft als ondertitel Een onderzoek naar praktisch redeneren, disposities en wilszwakte. De laatste term is daarbij cruciaal. Wat is wilszwakte - in het oud-Grieks akrasia of akrateia - en hoe valt het te verklaren? Wat gebeurt er pre

  1. Sport supporting act: terminology issues

    Directory of Open Access Journals (Sweden)

    Petr Vlček


    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.

  2. How many research nurses for how many clinical trials in an oncology setting? Definition of the Nursing Time Required by Clinical Trial-Assessment Tool (NTRCT-AT). (United States)

    Milani, Alessandra; Mazzocco, Ketti; Stucchi, Sara; Magon, Giorgio; Pravettoni, Gabriella; Passoni, Claudia; Ciccarelli, Chiara; Tonali, Alessandra; Profeta, Teresa; Saiani, Luisa


    Few resources are available to quantify clinical trial-associated workload, needed to guide staffing and budgetary planning. The aim of the study is to describe a tool to measure clinical trials nurses' workload expressed in time spent to complete core activities. Clinical trials nurses drew up a list of nursing core activities, integrating results from literature searches with personal experience. The final 30 core activities were timed for each research nurse by an outside observer during daily practice in May and June 2014. Average times spent by nurses for each activity were calculated. The "Nursing Time Required by Clinical Trial-Assessment Tool" was created as an electronic sheet that combines the average times per specified activities and mathematic functions to return the total estimated time required by a research nurse for each specific trial. The tool was tested retrospectively on 141 clinical trials. The increasing complexity of clinical research requires structured approaches to determine workforce requirements. This study provides a tool to describe the activities of a clinical trials nurse and to estimate the associated time required to deliver individual trials. The application of the proposed tool in clinical research practice could provide a consistent structure for clinical trials nursing workload estimation internationally.

  3. 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


    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.

  4. Current clinical trials testing combinations of immunotherapy and radiation. (United States)

    Crittenden, Marka; Kohrt, Holbrook; Levy, Ronald; Jones, Jennifer; Camphausen, Kevin; Dicker, Adam; Demaria, Sandra; Formenti, Silvia


    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 abscopal effect. Granulocyte-macrophage colony-stimulating factor was administered during radiotherapy to a metastatic site in patients with metastatic solid tumors to translate evidence obtained in a murine model of syngeneic mammary carcinoma treated with cytokine FLT-3L and radiation. Subsequent clinical availability of vaccines and immune checkpoint inhibitors has triggered a wave of enthusiasm for testing them in combination with radiotherapy. Examples of ongoing clinical trials are described in this report. Importantly, most of these trials include careful immune monitoring of the patients enrolled and will generate important data about the proimmunogenic effects of radiation in combination with a variety of immune modulators, in different disease settings. Results of these studies are building a platform of evidence for radiotherapy as an adjuvant to immunotherapy and encourage the growth of this novel field of radiation oncology.

  5. Acupuncture for Symptomatic Treatment of Fatigue in Parkinson's Disease: Trial Design and Implementation. (United States)

    Corbin, Lisa; Childs, Rebecca; Dilli, Caitlin; Christian, Mary K; Wong, Ban; Dong-Cedar, Daisy; Kluger, Benzi M


    Background: Acupuncture use is increasing worldwide for many conditions, including movement disorders. Clinical research in acupuncture has also increased to test anecdotal reports of clinical benefits empirically and investigate potential mechanisms. Method: This article describes considerations for designing a double-blinded, randomized, placebo-controlled clinical trial of acupuncture for fatigue in Parkinson's disease (PD) and describes the current authors' experience in the implementation and early conduct of this trial. Relevant literature is also reviewed to provide guidance for other researchers seeking to perform clinical research relevant to PD and related disorders. Results: Trial design should be driven by a well-defined research question and sufficient detail to meet Standards for Reporting Interventions in Clinical Trials of Acupuncture criteria when a trial is complete. Important items for review include: randomization and blinding; recruitment and participant selection; sham methodology choice; staff training; and practical implementation of study procedures. Sample forms used for the current authors' trial are shared. Conclusions: High-quality clinical trials of acupuncture can provide valuable information for clinicians, patients, and policymakers. Acupuncture trials differ in critical ways from pharmaceutical trials and might require additional considerations regarding design and implementation. Adequate preparation for the unique challenges of acupuncture studies can improve trial implementation, design, efficiency, and impact.

  6. Nonconsensual clinical trials: a foreseeable risk of offshoring under global corporatism. (United States)

    Spielman, Bethany


    This paper explores the connection of offshoring and outsourcing to nonconsensual global pharmaceutical trials in low-income countries. After discussing reasons why the topic of nonconsensual offshored clinical trials may be overlooked in bioethics literature, I suggest that when pharmaceutical corporations offshore clinical trials today, nonconsensual experiments are often foreseeable and not simply the result of aberrant ethical conduct by a few individuals. Offshoring of clinical trials is structured so that experiments can be presented as health care in a unique form of outsourcing from the host country to pharmaceutical corporations. Bioethicists' assessments of the risks and potential benefits of offshore corporate pharmaceutical trials should therefore systematically include not only the hoped for benefits and the risks of the experimental drug but also the risk that subjects will not have consented, as well as the broader international consequences of nonconsensual experimentation.

  7. Respirator Field Trials (United States)


    worden onder andere klimatologische omnstandigbeden bij bet onderzoek betrokken. TNO reportI DV2 2005-A15 1 5/34 Summary Previous studies show that...Standard Protocol K Leeuwarden: Shooting in a simulator TNO reportI DV2 2005-A15 I 8/34 Introduction In previous work, test equipment was developed for the...factor data is not very reliable and therefore presented in this report. TNO reportI DV2 2005-A15 1 16/34 5 Porton Down 5.1 Human Factors As experiment

  8. 34 CFR 300.4 - Act. (United States)


    ..., DEPARTMENT OF EDUCATION ASSISTANCE TO STATES FOR THE EDUCATION OF CHILDREN WITH DISABILITIES General Definitions Used in This Part § 300.4 Act. Act means the Individuals with Disabilities Education Act, as... 34 Education 2 2010-07-01 2010-07-01 false Act. 300.4 Section 300.4 Education Regulations of...

  9. 7 CFR 35.1 - Act. (United States)


    ... 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...

  10. Reconsidering Acting: a few improvised and provisory thoughts on acting today

    Directory of Open Access Journals (Sweden)

    Patrice Pavis


    Full Text Available This paper summarizes my thoughts during the presentation of the conference Acting reconsidered. The study of the actor in contemporary performances should be reevaluated in the light of the experiments of the last fifty years, particularly performance art, post-dramatic theatre, participative theatre and many political theatre. The new tasks and conceptions of the actor are introduced. Stanislavki’s notion of psychological realism is questioned. The suggestion of de-dramatizing, delocalizing, de-training the actor might help the actor to orient oneself in the world.

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

    Directory of Open Access Journals (Sweden)

    W. Vincken


    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

  12. 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


    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

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


    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. Acute Schizophrenia | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available nter, Randomized, Double-blind, Placebo-controlled Trial of Three Fixed Doses of OPC-34712 in the Treatment of Adults With Acute...2 in the Treatment of Adults With Acute Schizophrenia A.4.1Sponsor's protocol code number331-10-231 A.5.2US ... Information on the Trial E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute...ition or disease under investigation E.1.2Version 14.1 E.1.2Level LLT E.1.2Classification code 10001064 E.1.2Term Acute

  15. Acute Schizophrenia | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available 2, and 1 mg/day) in the Treatment of Adults With Acute Schizophrenia A.3.1Title ...of the trial for lay people, in easily understood, i.e. non-technical, language Efficacy Study of OPC-34712 in Adults With Acute...e Trial E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute...nder investigation E.1.2Version 14.0 E.1.2Level LLT E.1.2Classification code 10001064 E.1.2Term Acute schizo

  16. Design, analysis, and presentation of crossover trials

    Directory of Open Access Journals (Sweden)

    Guyatt Gordon H


    Full Text Available Abstract Objective Although crossover trials enjoy wide use, standards for analysis and reporting have not been established. We reviewed methodological aspects and quality of reporting in a representative sample of published crossover trials. Methods We searched MEDLINE for December 2000 and identified all randomized crossover trials. We abstracted data independently, in duplicate, on 14 design criteria, 13 analysis criteria, and 14 criteria assessing the data presentation. Results We identified 526 randomized controlled trials, of which 116 were crossover trials. Trials were drug efficacy (48%, pharmacokinetic (28%, and nonpharmacologic (30%. The median sample size was 15 (interquartile range 8–38. Most (72% trials used 2 treatments and had 2 periods (64%. Few trials reported allocation concealment (17% or sequence generation (7%. Only 20% of trials reported a sample size calculation and only 31% of these considered pairing of data in the calculation. Carry-over issues were addressed in 29% of trial's methods. Most trials reported and defended a washout period (70%. Almost all trials (93% tested for treatment effects using paired data and also presented details on by-group results (95%. Only 29% presented CIs or SE so that data could be entered into a meta-analysis. Conclusion Reports of crossover trials frequently omit important methodological issues in design, analysis, and presentation. Guidelines for the conduct and reporting of crossover trials might improve the conduct and reporting of studies using this important trial design.

  17. Clean Air Act. Revision 5

    Energy Technology Data Exchange (ETDEWEB)


    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.

  18. SCADA Application for ACTS Technology (United States)

    Fairbanks, Barry


    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.

  19. A matched crossover design for clinical trials. (United States)

    Simon, Laura J; Chinchilli, Vernon M


    Two design principles are used frequently in clinical trials: 1) A subject is "matched" or "paired" with a similar subject to reduce the chance that other variables obscure the primary comparison of interest. 2) A subject serves as his/her own control by "crossing over" from one treatment to another during the course of an experiment. There are situations in which it may be advantageous to use the two design principles - crossing over and matching - simultaneously. That is, it may be advantageous to conduct a "paired crossover design," in which each subject, while paired with a similar subject, crosses over and receives each experimental treatment. In this paper, we describe two clinical trials conducted by the National Heart, Lung and Blood Institute's Asthma Clinical Research Network that used a paired 2x2 crossover design. The Beta Adrenergic Response by GEnotype (BARGE) Study compared the effects of regular use of inhaled albuterol on mildly asthmatic patients with different genotypes at the 16th position of the beta-agonist receptor gene. The Smoking Modulates Outcomes of Glucocorticoid (SMOG) Therapy in Asthma Study evaluated the hypothesis that smoking reduces the response to inhaled corticosteroids. For such paired crossover designs, the primary parameter of interest is typically the treatment-by-pairing interaction term. In evaluating the relative efficiency of the paired 2x2 crossover design to two independent crossover designs with respect to this interaction term, we show that the paired 2x2 crossover design is more efficient if the correlations between the paired members on the same treatments are greater than their correlations on different treatments. This condition should hold in most circumstances, and therefore the paired crossover design deserves serious consideration for any clinical trial in which the crossing over and matching of subjects is deemed simultaneously beneficial.

  20. ACTS for distance education in developing countries (United States)

    Kalu, A; Ventre, G.


    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

  1. Exchanging Conflict Resolution in an Adaptable Implementation of ACT-R


    Gall, Daniel; Frühwirth, Thom


    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...

  2. A phase III randomised controlled trial of single-dose triple therapy in COPD: the IMPACT protocol. (United States)

    Pascoe, Steven J; Lipson, David A; Locantore, Nicholas; Barnacle, Helen; Brealey, Noushin; Mohindra, Rajat; Dransfield, Mark T; Pavord, Ian; Barnes, Neil


    Patients with symptomatic advanced chronic obstructive pulmonary disease (COPD) who experience recurrent exacerbations are particularly at risk of poor outcomes and present a significant burden on healthcare systems. The relative merits of treating with different inhaled combination therapies e.g. inhaled corticosteroids (ICS)/long-acting β2-agonist (LABA), LABA/long-acting muscarinic antagonists (LAMA), ICS/LABA/LAMA, in this patient group are poorly understood, as is reflected in current guidelines. The InforMing the PAthway of COPD Treatment (IMPACT) study will evaluate the efficacy and safety of fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) versus FF/VI or UMEC/VI over a 52-week treatment period. The study has been designed with a focus on understanding the comparative merits of each treatment modality in different phenotypes/endotypes.This is a phase III, randomised, double-blind, three-arm, parallel-group, global multicentre study comparing the rate of moderate and severe exacerbations between FF/UMEC/VI and FF/VI or UMEC/VI over a 52-week treatment period. The study aims to recruit 10 000 patients from approximately 1070 centres. Eligible patients are aged ≥40 years, with symptomatic advanced COPD (Global initiative for chronic Obstructive Lung Disease (GOLD) group D) and an exacerbation in the previous 12 months.The first patients were recruited to the IMPACT study ( NCT02164513) in June 2014 and the anticipated completion date is July 2017.

  3. Clinical trials on AIDS start. (United States)

    A 6-month clinical trial in the Philippines sought to determine the efficacy of coconut oil and of "monolaurin," a coconut oil byproduct, in killing HIV by breaking down its coating. This research is based on the theory that medium-chain fatty acids, like monolaurin, can have this effect on certain viruses. The trial involves 12 women and 3 men in the early stage of HIV infection. 10 patients will take different doses of monolaurin, and 5 will consume coconut oil. It is hypothesized that the regimen will lead to higher CD4 counts and a lower viral load. The trial was almost abandoned because it received only lukewarm approval from the Health Secretary.

  4. 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


    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.

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

    Directory of Open Access Journals (Sweden)

    Kaur Geetinder


    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

  6. [Reading a clinical trial report]. (United States)

    Bergmann, J F; Chassany, O


    To improve medical knowledge by reading clinical trial reports it is necessary to check for the respect of the methodological rules, and to analyze and criticize the results. A control group and a randomisation are always necessary. Double blind assessment, sample size calculation, intention to treat analysis, a unique primary end point are also important. The conclusions of the trial are valid only for the population included and the clinical signification of the results, depending on the control treatment, has to be evaluated. Respect of the reading rules is necessary to assess the reliability of the conclusions, in order to promote evidence-based practice.

  7. Innovations in clinical trials informatics. (United States)

    Summers, Ron; Vyas, Hiten; Dudhal, Nilesh; Doherty, Neil F; Coombs, Crispin R; Hepworth, Mark


    This paper will investigate innovations in information management for use in clinical trials. The application typifies a complex, adaptive, distributed and information-rich environment for which continuous innovation is necessary. Organisational innovation is highlighted as well as the technical innovations in workflow processes and their representation as an integrated set of web services. Benefits realization uncovers further innovations in the business strand of the work undertaken. Following the description of the development of this information management system, the semantic web is postulated as a possible solution to tame the complexity related to information management issues found within clinical trials support systems.

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


    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. Acute pancreatitis | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available lot Trial of Indomethacin in Acute Pancreatitis Ensayo piloto controlado y aleatorizado con indometacina en ....1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute...n criteria Patients ages 18 or above admitted to hospital with a diagnosis of Acute pancreatitis (AP) based

  10. Acute Rhinosinusitis | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available edical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute Rhinosinu....2.3Trial contains a sub-study No E.3Principal inclusion criteria 1. Adult male and female outpatients aged ≥ 18 - 75 years 2. Acute

  11. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

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


    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...

  12. "Speak Out. Act Up. Move Forward." Disobedience-Based Arts Education (United States)

    Kotin, Alison; Aguirre McGregor, Stella; Pellecchia, DeAnna; Schatz, Ingrid; Liu, Shaw Pong


    In this essay, Alison Kotin, Stella Aguirre McGregor, DeAnna Pellecchia, Ingrid Schatz, and Shaw Pong Liu reflect on their experiences working with public high school students to create "Speak Out. Act Up. Move Forward.," a performative response to current and historical acts of civil disobedience. The authors--a group of instructors…

  13. The Cost of Performance? Students' Learning about Acting as Change Agents in Their Schools (United States)

    Kehoe, Ian


    This paper explores how performance culture could affect students' learning about, and disposition towards, acting as organisational change agents in schools. This is based on findings from an initiative aimed to enable students to experience acting as change agents on an aspect of the school's culture that concerned them. The initiative…

  14. 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)


    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.)

  15. 20 CFR 627.245 - Work experience. (United States)


    ... PROGRAMS UNDER TITLES I, II, AND III OF THE ACT Program Requirements § 627.245 Work experience. (a) Definition. Work experience means a short-term or part-time training assignment with a public or private... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Work experience. 627.245 Section...

  16. The Physics of Bird Flight: An Experiment (United States)

    Mihail, Michael D.; George, Thomas F.; Feldman, Bernard J.


    This article describes an experiment that measures the forces acting on a flying bird during takeoff. The experiment uses a minimum of equipment and only an elementary knowledge of kinematics and Newton's second law. The experiment involves first digitally videotaping a bird during takeoff, analyzing the video to determine the bird's position as a…

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

    Directory of Open Access Journals (Sweden)

    Khan Muhammad


    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

  18. Monitoring Artificial Pancreas Trials Through Agent-based Technologies (United States)

    Scarpellini, Stefania; Di Palma, Federico; Toffanin, Chiara; Del Favero, Simone; Magni, Lalo; Bellazzi, Riccardo


    The increase in the availability and reliability of network connections lets envision systems supporting a continuous remote monitoring of clinical parameters useful either for overseeing chronic diseases or for following clinical trials involving outpatients. We report here the results achieved by a telemedicine infrastructure that has been linked to an artificial pancreas platform and used during a trial of the AP@home project, funded by the European Union. The telemedicine infrastructure is based on a multiagent paradigm and is able to deliver to the clinic any information concerning the patient status and the operation of the artificial pancreas. A web application has also been developed, so that the clinic staff and the researchers involved in the design of the blood glucose control algorithms are able to follow the ongoing experiments. Albeit the duration of the experiments in the trial discussed in the article was limited to only 2 days, the system proved to be successful for monitoring patients, in particular overnight when the patients are sleeping. Based on that outcome we can conclude that the infrastructure is suitable for the purpose of accomplishing an intelligent monitoring of an artificial pancreas either during longer trials or whenever that system will be used as a routine treatment. PMID:24876570

  19. Drug Development and Challenges for Neuromuscular Clinical Trials. (United States)

    El Mouelhi, Mohamed


    Drug development process faces many challenges, including those encountered in clinical trials for neuromuscular diseases. Drug development is a lengthy and highly costly process. Out of 10 compounds entering first study in man (phase 1), only one compound reaches the market after an average of 14 years with a cost of $2.7 billion. Nevertheless, according to the Centers for Medicare and Medicaid services, prescription drugs constituted only 9 % of each health care dollar spent in USA in 2013. Examples of challenges encountered in neuromuscular clinical trials include lack of validated patient-reported outcome tools, blinding issues, and the use of placebo in addition to lack of health authority guidance for orphan diseases. Patient enrollment challenge is the leading cause of missed clinical trial deadlines observed in about 80 % of clinical trials, resulting in delayed availability of potentially life-saving therapies. Another specific challenge introduced by recent technology is the use of social media and risk of bias. Sharing personal experiences while in the study could easily introduce bias among patients that would interfere with accurate interpretation of collected data. To minimize this risk, recent neuromuscular studies incorporate as an inclusion criterion the patient's agreement not to share any of study experiences through social media with other patients during the study conduct. Consideration of these challenges will allow timely response to the high unmet medical needs for many neuromuscular diseases.

  20. An integrated approach to consumer representation and involvement in a multicentre randomized controlled trial. (United States)

    Langston, Anne L; McCallum, Marilyn; Campbell, Marion K; Robertson, Clare; Ralston, Stuart H


    Although, consumer involvement in individual studies is often limited, their involvement in guiding health research is generally considered to be beneficial. This paper outlines our experiences of an integrated relationship between the organisers of a clinical trial and a consumer organisation. The PRISM trial is a UK multicentre, randomized controlled trial comparing treatment strategies for Paget's disease of the bone. The National Association for the Relief of Paget's Disease (NARPD) is the only UK support group for sufferers of Paget's disease and has worked closely with the PRISM team from the outset. NARPD involvement is integral to the conduct of the trial and specific roles have included: peer-review; trial steering committee membership; provision of advice to participants, and promotion of the trial amongst Paget's disease patients. The integrated relationship has yielded benefits to both the trial and the consumer organisation. The benefits for the trial have included: recruitment of participants via NARPD contacts; well-informed participants; unsolicited patient advocacy of the trial; and interested and pro-active collaborators. For the NARPD and Paget's disease sufferers, benefits have included: increased awareness of Paget's disease; increased access to relevant health research; increased awareness of the NARPD services; and wider transfer of diagnosis and management knowledge to/from health care professionals. Our experience has shown that an integrated approach between a trial team and a consumer organisation is worthwhile. Adoption of such an approach in other trials may yield significant improvements in recruitment and quality of participant information flow. There are, however, resource implications for both parties.

  1. Evaluating traditional Chinese medicine using modern clinical trial design and statistical methodology: application to a randomized controlled acupuncture trial. (United States)

    Lao, Lixing; Huang, Yi; Feng, Chiguang; Berman, Brian M; Tan, Ming T


    Traditional Chinese medicine (TCM), used in China and other Asian counties for thousands of years, is increasingly utilized in Western countries. However, due to inherent differences in how Western medicine and this ancient modality are practiced, employing the so-called Western medicine-based gold standard research methods to evaluate TCM is challenging. This paper is a discussion of the obstacles inherent in the design and statistical analysis of clinical trials of TCM. It is based on our experience in designing and conducting a randomized controlled clinical trial of acupuncture for post-operative dental pain control in which acupuncture was shown to be statistically and significantly better than placebo in lengthening the median survival time to rescue drug. We demonstrate here that PH assumptions in the common Cox model did not hold in that trial and that TCM trials warrant more thoughtful modeling and more sophisticated models of statistical analysis. TCM study design entails all the challenges encountered in trials of drugs, devices, and surgical procedures in the Western medicine. We present possible solutions to some but leave many issues unresolved.

  2. Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials. (United States)

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


    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

  3. Genetic pesticides: Monsanto goes ahead with trials. (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.

  4. Single-trial ERP analysis reveals facial expression category in a three-stage scheme. (United States)

    Zhang, Dandan; Luo, Wenbo; Luo, Yuejia


    Emotional faces are salient stimuli that play a critical role in social interactions. Following up on previous research suggesting that the event-related potentials (ERPs) show differential amplitudes in response to various facial expressions, the current study used trial-to-trial variability assembled from six discriminating ERP components to predict the facial expression categories in individual trials. In an experiment involved 17 participants, fearful trials were differentiated from non-fearful trials as early as the intervals of N1 and P1, with a mean predictive accuracy of 87%. Single-trial features in the occurrence of N170 and vertex positive potential could distinguish between emotional and neutral expressions (accuracy=90%). Finally, the trials associated with fearful, happy, and neutral faces were completely separated during the window of N3 and P3 (accuracy=83%). These categorization findings elucidated the temporal evolution of facial expression extraction, and demonstrated that the spatio-temporal characteristics of single-trial ERPs can distinguish facial expressions according to a three-stage scheme, with "fear popup," "emotional/unemotional discrimination," and "complete separation" as processing stages. This work constitutes the first examination of neural processing dynamics beyond multitrial ERP averaging, and directly relates the prediction performance of single-trial classifiers to the progressive brain functions of emotional face discrimination.

  5. Comparison communities in a cluster randomised trial innovate in response to 'being controlled'. (United States)

    Hawe, Penelope; Riley, Therese; Gartrell, Alexandra; Turner, Karen; Canales, Claudia; Omstead, Darlene


    We conducted qualitative interviews among primary health care teams and community agencies in eight communities in Victoria, Australia which had (1) agreed to be part of a universal primary care and community development intervention to reduce post natal depression and promote maternal health; and (2) were randomised to the comparison arm. The purpose was to document their experience with and interpretation of the trial. Although 'control' in a controlled trial refers to the control of confounding of the trial result by factors other than allocation to the intervention, participants interpreted 'control' to mean restrictions on what they were allowed to do during the trial period. They had agreed not to use the Edinburgh Post Natal Depression Scale or the SF 36 in clinical practice and not to implement any of the elements of the intervention. We found that no elements of the intervention were implemented. However, the extension of the trial from three to five years made the trial agreement a strain. The imposition of trial conditions also encouraged a degree of lateral thinking and innovation in service delivery (quality improvement). This may have potentially contributed to the null trial results. The observations invite interrogation of intervention theory and consequent rethinking of the way contamination in a cluster trial is defined.

  6. Motor learning without doing: trial-by-trial improvement in motor performance during mental training. (United States)

    Gentili, Rodolphe; Han, Cheol E; Schweighofer, Nicolas; Papaxanthis, Charalambos


    Although there is converging experimental and clinical evidences suggesting that mental training with motor imagery can improve motor performance, it is unclear how humans can learn movements through mental training despite the lack of sensory feedback from the body and the environment. In a first experiment, we measured the trial-by-trial decrease in durations of executed movements (physical training group) and mentally simulated movements (motor-imagery training group), by means of training on a multiple-target arm-pointing task requiring high accuracy and speed. Movement durations were significantly lower in posttest compared with pretest after both physical and motor-imagery training. Although both the posttraining performance and the rate of learning were smaller in motor-imagery training group than in physical training group, the change in movement duration and the asymptotic movement duration after a hypothetical large number of trials were identical. The two control groups (eye-movement training and rest groups) did not show change in movement duration. In the second experiment, additional kinematic analyses revealed that arm movements were straighter and faster both immediately and 24 h after physical and motor-imagery training. No such improvements were observed in the eye-movement training group. Our results suggest that the brain uses state estimation, provided by internal forward model predictions, to improve motor performance during mental training. Furthermore, our results suggest that mental practice can, at least in young healthy subjects and if given after a short bout of physical practice, be successfully substituted to physical practice to improve motor performance.

  7. 77 FR 36231 - Americans With Disabilities Act (ADA) and Architectural Barriers Act (ABA) Accessibility... (United States)


    ... Architectural Barriers Act (ABA) Accessibility Guidelines; Emergency Transportable Housing Units AGENCY... Disabilities Act (ADA) and Architectural Barriers Act (ABA) Accessibility Guidelines to specifically address... the ADA or ABA are readily accessible to and usable by individuals with disabilities. Other...

  8. Clinical Trials in Your Community (United States)

    The NCI Community Oncology Research Program (NCORP) is a national network of investigators, cancer care providers, academic institutions, and other organizations. NCORP conducts multi-site cancer clinical trials and studies in diverse populations in community-based healthcare systems across the United States and Puerto Rico.

  9. The Best Bypass Surgery Trial

    DEFF Research Database (Denmark)

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


    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 addit...

  10. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Questions to Ask about Your Diagnosis Research Cancer Treatment Types of Cancer Treatment Side Effects Clinical Trials Information A to Z ... Alternative Medicine (CAM) Questions to Ask about Your Treatment Research Coping with Cancer Feelings and Cancer Adjusting ...

  11. Glossary of Clinical Trials Terms (United States)

    ... National Institutes of Health grant numbers. (See also Secondary IDs data element on OUTCOME MEASURE A planned ... and Secondary Outcome Measure . (See also Primary and Secondary Outcome Measures data element and Outcome Measure results data element on ...

  12. 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


    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

  13. 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


    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

  14. Rhesus monkeys (Macaca mulatta) discriminate between knowing and not knowing and collect information as needed before acting. (United States)

    Hampton, Robert R; Zivin, Aaron; Murray, Elisabeth A


    Humans use memory awareness to determine whether relevant knowledge is available before acting, as when we determine whether we know a phone number before dialing. Such metacognition, or thinking about thinking, can improve selection of appropriate behavior. We investigated whether rhesus monkeys ( Macaca mulatta) are capable of a simple form of metacognitive access to the contents of short-term memory. Monkeys chose among four opaque tubes, one of which concealed food. The tube containing the reward varied randomly from trial to trial. On half the trials the monkeys observed the experimenter baiting the tube, whereas on the remaining trials their view of the baiting was blocked. On each trial, monkeys were allowed a single chance to select the tube containing the reward. During the choice period the monkeys had the opportunity to look down the length of each tube, to determine if it contained food. When they knew the location of the reward, most monkeys chose without looking. In contrast, when ignorant, monkeys often made the effort required to look, thereby learning the location of the reward before choosing. Looking improved accuracy on trials on which monkeys had not observed the baiting. The difference in looking behavior between trials on which the monkeys knew, and trials on which they were ignorant, suggests that rhesus monkeys discriminate between knowing and not knowing. This result extends similar observations made of children and apes to a species of Old World monkey, suggesting that the underlying cognitive capacities may be widely distributed among primates.

  15. 7 CFR 926.2 - Act. (United States)



  16. 7 CFR 1207.302 - Act. (United States)


    ... Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS AND ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE POTATO RESEARCH AND PROMOTION PLAN Potato Research and Promotion Plan Definitions § 1207.302 Act. Act means the Potato Research...

  17. The Penal Code (Amendment) Act 1989 (Act A727), 1989. (United States)


    In 1989, Malaysia amended its penal code to provide that inducing an abortion is not an offense if the procedure is performed by a registered medical practitioner who has determined that continuation of the pregnancy would risk the life of the woman or damage her mental or physical health. Additional amendments include a legal description of the conditions which constitute the act of rape. Among these conditions is intercourse with or without consent with a woman under the age of 16. Malaysia fails to recognize rape within a marriage unless the woman is protected from her husband by judicial decree or is living separately from her husband according to Muslim custom. Rape is punishable by imprisonment for a term of 5-20 years and by whipping.

  18. Speech acts, communication problems, and fighter pilot team performance. (United States)

    Svensson, Jonathan; Andersson, Jan

    Two aspects of team communication, speech acts and communication problems, and their relation to team performance in a team air combat simulator were studied. The purpose was to enhance the understanding of how team performance is related to team communication. Ten Swedish fighter pilots and four fighter controllers of varying experience participated. Data were collected during fighter simulator training involving four pilots and one fighter controller in each of two teams. Speech acts were collapsed over seven categories and communication problems over five categories. Communication was studied from two perspectives: critical situation outcome and mission outcome. Some problems were closely related to particular speech acts. Speech act frequency, especially meta-communications and tactics, was highest when winning. However, the timing of tactics in critical situations needs further research. Communication problem frequency was highest for runs which ended equally. The most common problem was simultaneous speech, possibly because of the simulator radio system. The number of speech acts was related to enhanced performance but in a complex manner. Thus in order to work efficiently team members need to communicate, but to communicate sufficiently and at appropriate times. This work has applications for fighter pilot and controller team training and the development of communication standards.

  19. Destruction of public and governmental experiments of GMO in Europe. (United States)

    Kuntz, Marcel


    The purpose of this article is to compile the destruction of GMO trials from academic or governmental research institutes in Europe, in a factual manner and to highlight their main characteristics. About 80 acts of vandalism against academic or governmental research on GMOs are identified, mainly in 4 countries; namely France, Germany, the United Kingdom and Switzerland. Examples are also provided for Italy and Belgium. The general conclusions that can be drawn from these acts are also discussed.

  20. Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations

    DEFF Research Database (Denmark)

    Christiansen, Jens Sandahl; Backeljauw, Philippe F; Bidlingmaier, Martin


    OBJECTIVE: The Growth Hormone (GH) Research Society convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting GH preparations (LAGH). PARTICIPANTS: A closed meeting of 55 international scientists with expertise in growth hormone, including pediatric...... and adult endocrinologists, basic scientists, regulatory scientists, and participants from the pharmaceutical industry. EVIDENCE: Current literature was reviewed for gaps in knowledge. Expert opinion was utilized to suggest studies required to address potential safety and efficacy issues. CONSENSUS PROCESS...

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

    Directory of Open Access Journals (Sweden)

    Mar Jimeno-Bulnes


    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

  2. An experimental trial exploring the impact of continuous transdermal alcohol monitoring upon alcohol consumption in a cohort of male students.

    Directory of Open Access Journals (Sweden)

    Fergus G Neville

    Full Text Available OBJECTIVE: To examine the impact of continuous transdermal alcohol monitoring upon alcohol consumption in male students at a Scottish university. METHOD: Using a within-subject mixed-methods design, 60 male university students were randomly allocated into three experimental conditions using AUDIT score stratified sampling. Participants in Conditions A and B were asked not to consume alcohol for a 14-day period, with those in Condition A additionally being required to wear a continuous transdermal alcohol monitoring anklet. Condition C participants wore an anklet and were asked to continue consuming alcohol as normal. Alcohol consumption was measured through alcohol timeline follow-back, and using data collected from the anklets where available. Diaries and focus groups explored participants' experiences of the trial. RESULTS: Alcohol consumption during the 14-day trial decreased significantly for participants in Conditions A and B, but not in C. There was no significant relative difference in units of alcohol consumed between Conditions A and B, but significantly fewer participants in Condition A drank alcohol than in Condition B. Possible reasons for this difference identified from the focus groups and diaries included the anklet acting as a reminder of commitment to the study (and the agreement to sobriety, participants feeling under surveillance, and the use of the anklet as a tool to resist social pressure to consume alcohol. CONCLUSIONS: The study provided experience in using continuous transdermal alcohol monitors in an experimental context, and demonstrated ways in which the technology may be supportive in facilitating sobriety. Results from the study have been used to design a research project using continuous transdermal alcohol monitors with ex-offenders who recognise a link between their alcohol consumption and offending behaviour.

  3. Clinical Trials: Key to Medical Progress (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 ...

  4. New Eczema Drug Promising in Early Trial (United States)

    ... page: New Eczema Drug Promising in Early Trial Nemolizumab significantly ... the appearance of moderate to severe eczema, a new, preliminary trial finds. Nemolizumab is a man-made, ...

  5. 7 CFR 29.13 - The act. (United States)


    ... 7 Agriculture 2 2010-01-01 2010-01-01 false The act. 29.13 Section 29.13 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing... INSPECTION Regulations Definitions § 29.13 The act. The Tobacco Inspection Act, approved August 23, 1935....

  6. 75 FR 41908 - Sunshine Act Meeting (United States)


    ... and rule and form amendments under the Investment Company Act of 1940, the Securities Act of 1933, and the Securities Exchange Act of 1934, to reform the regulation of distribution fees paid by registered open-end management investment companies (``funds''). The recommended proposal would provide a...

  7. 7 CFR 1219.1 - Act. (United States)


    ... ORDERS; MISCELLANEOUS COMMODITIES), DEPARTMENT OF AGRICULTURE HASS AVOCADO PROMOTION, RESEARCH, AND INFORMATION Hass Avocado Promotion, Research, and Information Order Definitions § 1219.1 Act. Act means the Hass Avocado Promotion, Research, and Information Act of 2000, Public Law 106-387, 7 U.S.C....

  8. 78 FR 63528 - Sunshine Act Meeting (United States)


    ... COMMISSION Sunshine Act Meeting Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold an Open Meeting on... sale of securities through crowdfunding pursuant to Section 4(a)(6) of the Securities Act of 1933,...

  9. 75 FR 57330 - Community Reinvestment Act (United States)


    ... Office of Thrift Supervision Community Reinvestment Act AGENCY: Office of Thrift Supervision (OTS... collection. Title of Proposal: Community Reinvestment Act. OMB Number: 1550-0012. Form Number: N/A. Description: The Community Reinvestment Act regulation requires the OTS, as well as the Office of...

  10. 75 FR 44852 - Community Reinvestment Act Sunshine (United States)


    ... Office of Thrift Supervision Community Reinvestment Act Sunshine AGENCY: Office of Thrift Supervision... collection. Title of Proposal: Community Reinvestment Act Sunshine. OMB Number: 1550-0105. Form Number: N/A... agreements that are in fulfillment of the Community Reinvestment Act of 1977 to be disclosed to the...

  11. 29 CFR 1614.203 - Rehabilitation Act. (United States)


    ... 29 Labor 4 2010-07-01 2010-07-01 false Rehabilitation Act. 1614.203 Section 1614.203 Labor... EMPLOYMENT OPPORTUNITY Provisions Applicable to Particular Complaints § 1614.203 Rehabilitation Act. (a... Rehabilitation Act of 1973, as amended (29 U.S.C. 791), has been violated in a complaint alleging...

  12. 12 CFR 268.203 - Rehabilitation Act. (United States)


    ... 12 Banks and Banking 3 2010-01-01 2010-01-01 false Rehabilitation Act. 268.203 Section 268.203... Rehabilitation Act. (a) Model employer. The Board shall be a model employer of individuals with disabilities. The... Rehabilitation Act of 1973, as amended (29 U.S.C. 791), has been violated in a complaint alleging...

  13. 7 CFR 1205.10 - Act. (United States)


    ... 7 Agriculture 10 2010-01-01 2010-01-01 false Act. 1205.10 Section 1205.10 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS AND... for Conduct of Sign-up Period Definitions § 1205.10 Act. The term Act means the Cotton Research...

  14. 12 CFR 619.9000 - The Act. (United States)


    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false The Act. 619.9000 Section 619.9000 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM DEFINITIONS § 619.9000 The Act. The Farm Credit Act of 1971; Pub. L. 92-181 and amendments....

  15. Acute Gout | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute Gou...t E.1.1.1Medical condition in easily understood language Acute Gout E.1.1.2Therapeutic area Diseases [C] - M...n the trial (if it is different from the expected normal treatment of that condition) Acute gout is a self l

  16. Clinical Trials Management | Division of Cancer Prevention (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.

  17. The Design of Cluster Randomized Crossover Trials (United States)

    Rietbergen, Charlotte; Moerbeek, Mirjam


    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. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram


    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...

  19. Personal Information as Communicative Acts

    DEFF Research Database (Denmark)

    Mai, Jens-Erik


    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.......The paper extends previous accounts of informational privacy as a contextual notion. Where previous accounts have focused on interpretations of the privacy context itself as being contextual and open for negotiation and interpretation, this paper extends those analyses and shows that personal...... information itself is in fact best understood as contextual and situational—and as such open for interpretation. The paper reviews the notion of information as it has been applied in informational privacy and philosophy of information, and suggests that personal information ought to be regarded...

  20. The European Model Company Act

    DEFF Research Database (Denmark)

    Cleff, Evelyne Beatrix


    European Company Law regulation is currently undergoing a reform. These reforms raise a number of regulatory questions, such as what should be the aims of companies' legislation, and how these aims should best be met by regulation. Many of the reforms and discussions (both on EU and national level......) on the organisation of company laws reflect an interesting paradigm shift. Whereas, previously company law was primarily focused on preventing abuse, there is now a trend towards legislation that promote commerce and satisfy the needs of business. This means that the goal of economic efficiency is having...... an increasing influence on the framing of company legislation, such as the choice between mandatory or default rules. This article introduces the project 'European Company Law and the choice of Regulatory Method' which is carried out in collaboration with the 'European Model Company Act Group'. The project aims...

  1. Learning activism, acting with phronesis (United States)

    Lee, Yew-Jin


    The article "Socio-political development of private school children mobilising for disadvantaged others" by Darren Hoeg, Natalie Lemelin, and Lawrence Bencze described a language-learning curriculum that drew on elements of Socioscientific issues and Science, Technology, Society and Environment. Results showed that with a number of enabling factors acting in concert, learning about and engagement in practical action for social justice and equity are possible. An alternative but highly compatible framework is now introduced—phronetic social research—as an action-oriented, wisdom-seeking research stance for the social sciences. By so doing, it is hoped that forms of phronetic social research can gain wider currency among those that promote activism as one of many valued outcomes of an education in science.

  2. Dendritic tellurides acting as antioxidants

    Institute of Scientific and Technical Information of China (English)

    XU Huaping; WANG Yapei; WANG Zhiqiang; LIU Junqiu; Mario Smet; Wim Dehaen


    We have described the synthesis of a series of poly(aryl ether) dendrimers with telluride in the core and oligo(ethylene oxide) chains at the periphery which act as glutathione peroxidase (GPx) mimics. These series of compounds were well characterized by 1H-NMR, 13C-NMR and ESI-MS. Using different ROOH (H2O2, cumene hydroperoxide) for testing the antioxidizing properties of these compounds, we have found that from generation 0 to 2, the activity of the dendritic GPx mimics first decreased and then increased. This can be explained on the basis of a greater steric hindrance, going from generation 0 to 1, and stronger binding interactions going from generation 1 to 2. In other words, there exists a balance between binding interactions and steric hindrance that may optimize the GPx activity.

  3. Customer experience


    Koperdáková, Zuzana


    Bachelor thesis deals with the theme of customer experience and terms related to this topic. The thesis consists of three parts. The first part explains the terms generally, as the experience or customer loyalty. The second part is dedicated to medotology used for Customer Experience Management. In the third part is described application of Customer Experience Management in practice, particularly in the context Touch Point Analyses in GE Money Bank.

  4. ROC Trials Update on Prehospital Hypertonic Saline Resuscitation in the Aftermath of the US-Canadian Trials (United States)


    cardiac output and, most importantly, survival. Later experiments performed in sheep (10) and swine (11) added 6% dextran-70 to sustain these improved...requiring blood transfusions or surgery ) (14,30-34). In addition, in a trial by Vassar et al, (35), no differences were observed between patients who...Holcroft JW. A comparison of several hypertonic solutions for resuscitation of bled sheep . J Surg Res. 1985;39(6):517-28,

  5. Trial-to-Trial Fluctuations in Attentional State and Their Relation to Intelligence (United States)

    Unsworth, Nash; McMillan, Brittany D.


    Trial-to-trial fluctuations in attentional state while performing measures of intelligence were examined in the current study. Participants performed various measures of fluid and crystallized intelligence while also providing attentional state ratings prior to each trial. It was found that pre-trial attentional state ratings strongly predicted…

  6. Psychology Experiments. (United States)

    McGraw, Ken; Tew, Mark D.; Williams, John E.


    A goal of the PsychExperiments project was to reduce the financial burden on psychology departments for hardware/software used in their laboratories. In its third year, the PsychExperiments site now hosts 39 experiments. Over 200 classrooms worldwide have signed up as official site users and there have been nearly 10,000 data sessions conducted.…

  7. Accrual to Cancer Clinical Trials

    LENUS (Irish Health Repository)

    Kelly, C


    Accrual to cancer clinical trials (CCT) is imperative to safeguard continued improvement in cancer outcomes. A retrospective chart review was performed of patients (n=140) starting a new anti-cancer agent in a north Dublin cancer centre. This review was performed over a four-month period, beginning in November 2015. Only 29% (n=41) had a CCT option. The overall accrual rate to CCT was 5% (n=7), which is comparable to internationally reported figures. The main reasons for failure to recruit to CCT included the lack of a CCT option for cancer type (n=30, 23%), stage (n=25, 19%), and line of treatment (n=23, 17%). Over the last decade, the rate of accrual to CCTs has in fact doubled and the number of trials open to recruitment has tripled. Ongoing governmental and philanthropic support is necessary to continue this trend to further expand CCT patient options with a target accrual rate of 10%.

  8. Medical coding in clinical trials

    Directory of Open Access Journals (Sweden)

    Deven Babre


    Full Text Available Data generated in all clinical trial are recorded on the data collection instrument Case report Form / Electronic Case Report Form by investigators located at various sites in various countries. In multicentric clinical trials since different investigator or medically qualified experts are from different sites / centers recording the medical term(s uniformly is a big challenge. Medical coders from clinical data management team process these terms and perform medical coding. Medical coding is performed to categorize the medical terms reported appropriately so that they can be analyzed/reviewed. This article describes process which is used for medical coding in clinical data management and two most commonly used medical dictionaries MedDRA and WHO-DDE in brief. It is expected to help medical coders to understand the process of medical coding in clinical data management. Few common issues which the medical coder faces while performing medical coding, are also highlighted.

  9. National Energy Act statutes and solar energy

    Energy Technology Data Exchange (ETDEWEB)

    Howard, J.


    The National Energy Act of 1978 contains many provisions that will significantly affect solar technology commercialization and solar energy users. Four of the five statutes that comprise the National Energy Act deserve close attention. The National Energy Conservation Policy Act will promote residential solar installations. The Energy Tax Act will accelerate both residential and commercial solar system applications. The Public Utilities Regulatory Policies Act promotes efficient use of utility resources as well as decentralized power production. And, the Power Plan and Industrial Fuel Use Act places severe restrictions on future burning of petroleum and natural gas, which should lead some operators to build or convert to solar energy systems. Each of the preceding acts are considered in separate sections of this report. Federal regulations issued pursuant to the various provisions are also identified and discussed, and some of the problems with the provisions and regulations are noted.

  10. 76 FR 64112 - Privacy Act of 1974; Privacy Act System of Records Appendices (United States)


    ... SPACE ADMINISTRATION Privacy Act of 1974; Privacy Act System of Records Appendices AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Revisions of NASA Appendices to Privacy Act System of... publishes with the Agency's systems of records under the Privacy Act of 1974. This notice publishes...

  11. 78 FR 77719 - Privacy Act of 1974; Privacy Act System of Records (United States)


    ... SPACE ADMINISTRATION Privacy Act of 1974; Privacy Act System of Records AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of Privacy Act system of records. SUMMARY: Pursuant to the provisions of the Privacy Act of 1974 (5 U.S.C. 552a), the National Aeronautics and Space Administration...

  12. 12 CFR 741.214 - Report of crime or catastrophic act and Bank Secrecy Act compliance. (United States)


    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Report of crime or catastrophic act and Bank Secrecy Act compliance. 741.214 Section 741.214 Banks and Banking NATIONAL CREDIT UNION ADMINISTRATION... Unions § 741.214 Report of crime or catastrophic act and Bank Secrecy Act compliance. Any credit...

  13. Clinical trials and gender medicine

    Directory of Open Access Journals (Sweden)

    Mariarita Cassese


    Full Text Available Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22% which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  14. The DiaS trial

    DEFF Research Database (Denmark)

    Andreasson, Kate; Krogh, Jesper; Rosenbaum, Bent


    BACKGROUND: In Denmark 8,000 to 10,000 people will attempt suicide each year. The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior, and a recent survey has shown that 30% of the patients are suffering from borderline personali...... measured at week 28. Other exploratory outcomes are included such as severity of symptoms, suicide intention and ideation, depression, hopelessness, self-esteem, impulsivity, anger, and duration of respective treatments. TRIAL REGISTRATION: Clinical NCT01512602....... disorder. The majority of patients (70% to 75%) with borderline personality disorder have a history of deliberate self-harm and 10% have a lifetime risk to die by suicide. The DiaS trial is comparing dialectical behavior therapy with collaborative assessment and management of suicidality......-informed supportive psychotherapy, for the risk of repetition of deliberate self-harm in patients with a recent suicide attempt and personality traits within the spectrum of borderline personality disorder. Both treatments have previously shown effects in this group of patients on suicide ideation and self...

  15. The Next Experiment

    Energy Technology Data Exchange (ETDEWEB)

    Novella, P.


    The full text of publication follows: The NEXT experiment will search for the neutrinoless double beta decay with a high-pressure gas- Xenon TPC. Xe{sup 136} is a {beta}{beta}0{nu} emitter and yields an excellent energy resolution when used as a calorimeter, acting both as the source and as the active material of the detector. External backgrounds can be rejected by means of the tracking capabilities of the TPC. A detector containing about 100 kg Xe{sup 136} is expected to be installed at Canfranc Underground Laboratory. (author)

  16. ACTS: from ATLAS software towards a common track reconstruction software

    CERN Document Server

    Gumpert, Christian; The ATLAS collaboration


    Reconstruction of charged particles' trajectories is a crucial task for most particle physics experiments. The high instantaneous luminosity achieved at the LHC leads to a high number of proton-proton collisions per bunch crossing, which has put the track reconstruction software of the LHC experiments through a thorough test. Preserving track reconstruction performance under increasingly difficult experimental conditions, while keeping the usage of computational resources at a reasonable level, is an inherent problem for many HEP experiments. Exploiting concurrent algorithms and using multivariate techniques for track identification are the primary strategies to achieve that goal. Starting from current ATLAS software, the ACTS project aims to encapsulate track reconstruction software into a generic, framework- and experiment-independent software package. It provides a set of high-level algorithms and data structures for performing track reconstruction tasks as well as fast track simulation. The software is de...

  17. Current status and perspectives of interventional clinical trials for glioblastoma - analysis of (United States)

    Cihoric, Nikola; Tsikkinis, Alexandros; Minniti, Giuseppe; Lagerwaard, Frank J; Herrlinger, Ulrich; Mathier, Etienne; Soldatovic, Ivan; Jeremic, Branislav; Ghadjar, Pirus; Elicin, Olgun; Lössl, Kristina; Aebersold, Daniel M; Belka, Claus; Herrmann, Evelyn; Niyazi, Maximilian


    The records of 208.777 (100%) clinical trials registered at were downloaded on the 19th of February 2016. Phase II and III trials including patients with glioblastoma were selected for further classification and analysis. Based on the disease settings, trials were classified into three groups: newly diagnosed glioblastoma, recurrent disease and trials with no differentiation according to disease setting. Furthermore, we categorized trials according to the experimental interventions, the primary sponsor, the source of financial support and trial design elements. Trends were evaluated using the autoregressive integrated moving average model. Two hundred sixteen (0.1%) trials were selected for further analysis. Academic centers (investigator initiated trials) were recorded as primary sponsors in 56.9% of trials, followed by industry 25.9%. Industry was the leading source of monetary support for the selected trials in 44.4%, followed by 25% of trials with primarily academic financial support. The number of newly initiated trials between 2005 and 2015 shows a positive trend, mainly through an increase in phase II trials, whereas phase III trials show a negative trend. The vast majority of trials evaluate forms of different systemic treatments (91.2%). In total, one hundred different molecular entities or biologicals were identified. Of those, 60% were involving drugs specifically designed for central nervous system malignancies. Trials that specifically address radiotherapy, surgery, imaging and other therapeutic or diagnostic methods appear to be rare. Current research in glioblastoma is mainly driven or sponsored by industry, academic medical oncologists and neuro-oncologists, with the majority of trials evaluating forms of systemic therapies. Few trials reach phase III. Imaging, radiation therapy and surgical procedures are underrepresented in current trials portfolios. Optimization in research portfolio for glioblastoma is needed.

  18. Portfolio of prospective clinical trials including brachytherapy: an analysis of the database


    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina


    Background To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. Methods The records of 175,538 (100 %) clinical trials registered at were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, p...

  19. Portfolio of prospective clinical trials including brachytherapy: an analysis of the database


    Cihoric, Nikola; Tsikkinis, Alexandros; Gutierrez Miguelez, Cristina; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina


    Background To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. Methods The records of 175,538 (100 %) clinical trials registered at were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type,...

  20. Biomarker-based adaptive trials for patients with glioblastoma--lessons from I-SPY 2. (United States)

    Alexander, Brian M; Wen, Patrick Y; Trippa, Lorenzo; Reardon, David A; Yung, Wai-Kwan Alfred; Parmigiani, Giovanni; Berry, Donald A


    The traditional clinical trials infrastructure may not be ideally suited to evaluate the numerous therapeutic hypotheses that result from the increasing number of available targeted agents combined with the various methodologies to molecularly subclassify patients with glioblastoma. Additionally, results from smaller screening studies are rarely translated to successful larger confirmatory studies, potentially related to a lack of efficient control arms or the use of unvalidated surrogate endpoints. Streamlining clinical trials and providing a flexible infrastructure for biomarker development is clearly needed for patients with glioblastoma. The experience developing and implementing the I-SPY studies in breast cancer may serve as a guide to developing such trials in neuro-oncology.