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Sample records for clinical protocols

  1. Universal protocol for alopecia areata clinical studies.

    Science.gov (United States)

    Mesinkovska, Natasha A; Bergfeld, Wilma F

    2013-12-01

    Within the area of alopecia areata research, there is an obvious need for well-designed clinical trials of therapeutic agents. The National Alopecia Areata Foundation (NAAF) has created an initiative for the development of a unified protocol with guidelines for clinical studies. The NAAF universal protocol represents a joint effort of clinicians and investigators with experience in treating alopecia areata. This protocol will serve as a tremendous resource to facilitate future clinical studies. PMID:24326554

  2. Mammascintigraphy: fundamentals, protocols, clinical application

    International Nuclear Information System (INIS)

    Radiopharmaceuticals, methods and results of clinical application of mammascintigraphy are reviewed. The main advantage of mammascintigraphy is its higher (at least 90%) specificity in comparison with X-ray mammography, possibility of using it in patients with X-ray dense gland, predicting cancer metastases and follow-up of tumor regression during chemotherapy. Mammascintigraphy is an effective reliable method of accurate diagnosis of breast cancer, which should be introduced in clinical practice of Russian breast cancer control centers as soon as possible

  3. Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees

    Science.gov (United States)

    Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

    2016-01-01

    A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. PMID:26811365

  4. Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

    Science.gov (United States)

    Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

    2016-04-01

    A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. PMID:26811365

  5. Clinical dosimetry in molecular radiotherapy: protocol optimization and clinical implementation

    International Nuclear Information System (INIS)

    Molecular radiotherapy (mrt) consists in destructing tumour targets by radiolabelled vectors. This nuclear medicine specialty is being considered with increasing interest for example via the success achieved in the treatment of non-Hodgkin lymphomas by radioimmunotherapy. One of the keys of mrt optimization relies on the personalising of absorbed doses delivered to the patient: This is required to ascertain that irradiation is focused on tumour cells while keeping surrounding healthy tissue irradiation at an acceptable - non-toxic - level. Radiation dose evaluation in mrt requires in one hand, the spatial and temporal localization of injected radioactive sources by scintigraphic imaging, and on a second hand, the knowledge of the emitted radiation propagating media, given by CT imaging. Global accuracy relies on the accuracy of each of the steps that contribute to clinical dosimetry. There is no reference, standardized dosimetric protocol to date. Due to heterogeneous implementations, evaluation of the accuracy of the absorbed dose is a difficult task. In this thesis, we developed and evaluated different dosimetric approaches that allow us to find a relationship between the absorbed dose to the bone marrow and haematological toxicity. Besides, we built a scientific project, called DosiTest, which aims at evaluating the impact of the various step that contribute to the realization of a dosimetric study, by means of a virtual multicentric comparison based on Monte-Carlo modelling. (author)

  6. Meeting pragmatism halfway: making a pragmatic clinical trial protocol.

    Science.gov (United States)

    Rushforth, Alexander

    2015-11-01

    Pragmatic clinical trials (PCTs) are today an increasingly prominent means of measuring the 'effectiveness' of healthcare interventions in 'real world' clinical settings, in order to produce evidence on which to base regulatory and clinical decision-making. Although several sociological studies have shown persuasively how PCTs are co-constructed within particular healthcare systems in which they are based, they have tended to focus on relatively later stages in careers of trials. The paper contributes to literature by considering how the 'real world' of the UK National Health Service (NHS) is incorporated into the design of a research protocol. Drawing on a meeting held just prior to patient recruitment for a PCT in maternal health, the paper analyses a trial collective's efforts to purify the messy domain of NHS clinical care into the orderly confines of the protocol (Law 2004), which meant satisfying demands for both scientific and social robustness (c.f. Nowotny et al. 2001). The findings show how efforts to inscribe robustness into the PCT protocol were themselves mediated through epistemic and regulatory conventions surrounding protocols as devices in healthcare research. Finally it is argued that meetings constitute an important epistemic instrument through which to settle various emerging tensions in PCT protocol design. PMID:26235211

  7. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

    OpenAIRE

    Chan, An-Wen; Tetzlaff, Jennifer M; Gøtzsche, Peter C.; Altman, Douglas G.; Mann, Howard; Berlin, Jesse A.; Dickersin, Kay; Hróbjartsson, Asbjørn; Schulz, Kenneth F; Parulekar, Wendy R.; Krleža-Jerić, Karmela; Laupacis, Andreas; Moher, David

    2013-01-01

    High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. Thi...

  8. Uterine transplantation research: laboratory protocols for clinical application.

    Science.gov (United States)

    Díaz-García, C; Johannesson, L; Enskog, A; Tzakis, A; Olausson, M; Brännström, M

    2012-02-01

    The aim of this review is to summarize the state-of the-art methods that are used in clinical organ transplantation today, as well as the major findings of recent experimental uterus transplantation (UTx) research regarding organ donation/retrieval, ischemic preservation, surgical techniques for anastomosis, immunosuppression and pregnancy. Absolute uterine factor infertility lacks treatment despite the major developments in infertility treatment and assisted reproduction. Concerning uterine factor infertile patients, genetic motherhood is only possible through gestational surrogacy. The latter can pose medical, ethical and legal concerns such as lack of control of life habits during surrogate pregnancy, economic motives for women to become surrogate mothers, medical/psychological pregnancy-related risks of the surrogate mother and uncertainties regarding the mother definition. Thus, surrogacy is non-approved in large parts of the world. Recent advances in the field of solid organ transplantation and experimental UTx provide a favourable and safe background in a scenario in which a human clinical UTx trial can take place. Protocols based on animal research over the last decade are described with a view to providing a scientifically guided approach to human UTx as an experimental procedure in the future. PMID:21900333

  9. PROPOSAL OF GUIDELINE FOR CLINICAL TRIAL PROTOCOLS WITH HERBAL DRUGS

    Directory of Open Access Journals (Sweden)

    Migdacelys Arboláez Estrada.

    2007-04-01

    Full Text Available SUMMARYCuba has extensive experience about herbal drugs, however only a few products get to the clinical phase of drug development. Our objective was to design new guidelines for clinical trials with herbal drugs.A detailed bibliographic search about regulatory aspects about clinical trials in Cuba and the world was done for development of the guideline. The guideline's proposed format includes: 1 Index, including the classification of the content. 2 Summary, 3 Fifteen chapters, related to the clinical trials. The guideline also propose the inclusion of annexes.A new guideline containing 15 chapters allows for writing more clear and detailed clinical trial protocols. The guideline contains the information required to guide the research staff who is interested in the validation of herbal drugs pharmacological activations from the perspective of clinical trials. RESUMEN Cuba tiene experiencia extensa sobre plantas medicinales, aunque solo algunos productos llegan a una fase clínica del desarrollo. Nuestro objetivo fué diseñar una nueva guía para ensayos clínicos con plantas medicinales.Hemos realizado una detallada búsqueda bibliográfica sobre aspectos reguladores de ensayos clínicos en Cuba y el resto del mundo para el desarrollo de la guía. El formato propuesto de la guia incluye: 1 Índice, incluyendo la clasificación de los contenidos. 2 Resumen, 3 Quince capítulos, relacionados con los ensayos clínicos. La guía también propone la inclusión de anexos.La nueva guía que contiene 15 capítulos que orientan la redacción de protocolos de ensayos clínicos más claros y más detallados. La guía contiene la información requerida para orientar al personal investigador interesado en la validación de la actividad farmacológica de las plantas medicinales desde la perspectiva de los ensayos clínicos.

  10. Capturing Provenance, Evolution and Modification of Clinical Protocols via a Heterogeneous, Semantic Social Network.

    Science.gov (United States)

    Portokallidis, Nick; Drosatos, George; Kaldoudi, Eleni

    2016-01-01

    Healthcare delivery is largely based on medical best practices as in clinical protocols. Research so far has addressed the computerized execution of clinical protocols by developing a number of related representation languages, execution engines and integrated platforms to support real time execution. However, much less effort has been put into organizing clinical protocols for use and reuse. In this paper we propose a heterogeneous semantic social network to describe and organize clinical protocols based on their provenance, evolution and modifications. The proposed approach allows semantic tagging and enrichment of clinical protocols so that they can be used and re-used across platforms and also be linked directly to other relevant scientific information, e.g. published works in PubMed or personal health records, and other clinical information systems. PMID:27332270

  11. Economic evaluation of a clinical protocol for diagnosing emergency patients with suspected pulmonary embolism

    OpenAIRE

    Gospodarevskaya, Elena V; Goergen, Stacy K; Harris, Anthony H; Chan, Thomas; de Campo, John F; Wolfe, Rory; Gan, Eng T; Wheeler, Michael B.; McKay, John

    2006-01-01

    Background The objective of this paper is to estimate the amount of cost-savings to the Australian health care system from implementing an evidence-based clinical protocol for diagnosing emergency patients with suspected pulmonary embolism (PE) at the Emergency department of a Victorian public hospital with 50,000 presentations in 2001–2002. Methods A cost-minimisation study used the data collected in a controlled clinical trial of a clinical protocol for diagnosing patients with suspected PE...

  12. A critical analysis of a locally agreed protocol for clinical practice

    International Nuclear Information System (INIS)

    Within the traditional scope of radiographic practice (including advanced practice) there is a need to demonstrate effective patient care and management. Such practice should be set within a context of appropriate evidence and should also reflect peer practice. In order to achieve such practice the use of protocols is encouraged. Effective protocols can maximise care and management by minimising inter- and intra-professional variation; they can also allow for detailed procedural records to be kept in case of legal claims. However, whilst literature exists to encourage the use of protocols there is little published material available to indicate how to create, manage and archive them. This article uses an analytical approach to propose a suitable method for protocol creation and archival, it also offers suggestions on the scope and content of a protocol. To achieve this an existing clinical protocol for radiographer reporting barium enemas is analysed to draw out the general issues. Proposals for protocol creation, management, and archival were identified. The clinical practice described or inferred in the protocol should be drawn from evidence, such evidence could include peer-reviewed material, national standards and peer practice. The protocol should include an explanation of how to proceed when the radiographers reach the limit of their ability. It should refer to the initial training required to undertake the clinical duties as well as the on-going continual professional updating required to maintain competence. Audit of practice should be indicated, including the preferred audit methodology, and associated with this should be a clear statement about standards and what to do if standards are not adequately met. Protocols should be archived, in a paper-based form, for lengthy periods in case of legal claims. On the archived protocol the date it was in clinical use should be included

  13. Hearing screening procedures and protocols in use at immunisation clinics in South Africa

    OpenAIRE

    Luisa Petrocchi-Bartal; Katijah Khoza-Shangase

    2014-01-01

    Background: There exists a need for context-relevant research aimed at facilitating the efficacious provision of early hearing detection and intervention services in South Africa.Objectives: This study aimed to determine the hearing screening procedures and protocols as well as referral protocols in use at maternal child woman’s health (MCWH) immunisation clinics in South Africa.Method: Thirty primary health care immunisation clinic managers or acting managers were interviewed in two South Af...

  14. Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols

    OpenAIRE

    Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre

    2015-01-01

    Background International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. Methods It was a doc...

  15. Clinical evaluation of a breathing protocol for PET/CT

    Energy Technology Data Exchange (ETDEWEB)

    Juan, Ramon de [Division of Nuclear Medicine, University Hospital Zurich, 8091, Zurich (Switzerland); Department of Nuclear Medicine, San Carlos University Hospital, Madrid (Spain); Seifert, Burkhardt [Department of Biostatistics, University of Zurich, Zurich (Switzerland); Berthold, Thomas; Schulthess, Gustav K. von; Goerres, Gerhard W. [Division of Nuclear Medicine, University Hospital Zurich, 8091, Zurich (Switzerland)

    2004-06-01

    The aim of this study was to assess the frequency and severity of respiration-induced curvilinear respiration artifacts (RICA) on co-registered positron emission tomography/computed tomography (PET/CT) images acquired on a combined PET/CT scanner before and after modifying the respiration protocol for CT scanning, with retrospective analysis of two groups of 100 patients each, before and after implementing a respiration protocol with breath-hold (BH) in the normal expiration position for the acquisition of the CT images. The CT data were used as attenuation map and for image co-registration. A ranking of co-registered PET/CT and PET images (including maximum intensity projection) was done by two observers in consensus using a scale from 0 to 3. Zero indicated that no RICA was visible and 1, 2, and 3 described artifact with increasing severity. A significant difference in RICA occurrence was found between the two groups (p<0.0001). There was a 45% decrease of artifact frequency when using the normal expiration protocol and a 68% decrease of grade-2 and grade-3 artifacts (p=0.004). The results of this study suggest that BH during the normal expiration position for CT scanning can be recommended to reduce the occurrence and the severity of RICA on PET/CT. (orig.)

  16. Clinical evaluation of a breathing protocol for PET/CT

    International Nuclear Information System (INIS)

    The aim of this study was to assess the frequency and severity of respiration-induced curvilinear respiration artifacts (RICA) on co-registered positron emission tomography/computed tomography (PET/CT) images acquired on a combined PET/CT scanner before and after modifying the respiration protocol for CT scanning, with retrospective analysis of two groups of 100 patients each, before and after implementing a respiration protocol with breath-hold (BH) in the normal expiration position for the acquisition of the CT images. The CT data were used as attenuation map and for image co-registration. A ranking of co-registered PET/CT and PET images (including maximum intensity projection) was done by two observers in consensus using a scale from 0 to 3. Zero indicated that no RICA was visible and 1, 2, and 3 described artifact with increasing severity. A significant difference in RICA occurrence was found between the two groups (p<0.0001). There was a 45% decrease of artifact frequency when using the normal expiration protocol and a 68% decrease of grade-2 and grade-3 artifacts (p=0.004). The results of this study suggest that BH during the normal expiration position for CT scanning can be recommended to reduce the occurrence and the severity of RICA on PET/CT. (orig.)

  17. Feasibility of Automatic Extraction of Electronic Health Data to Evaluate a Status Epilepticus Clinical Protocol.

    Science.gov (United States)

    Hafeez, Baria; Paolicchi, Juliann; Pon, Steven; Howell, Joy D; Grinspan, Zachary M

    2016-05-01

    Status epilepticus is a common neurologic emergency in children. Pediatric medical centers often develop protocols to standardize care. Widespread adoption of electronic health records by hospitals affords the opportunity for clinicians to rapidly, and electronically evaluate protocol adherence. We reviewed the clinical data of a small sample of 7 children with status epilepticus, in order to (1) qualitatively determine the feasibility of automated data extraction and (2) demonstrate a timeline-style visualization of each patient's first 24 hours of care. Qualitatively, our observations indicate that most clinical data are well labeled in structured fields within the electronic health record, though some important information, particularly electroencephalography (EEG) data, may require manual abstraction. We conclude that a visualization that clarifies a patient's clinical course can be automatically created using the patient's electronic clinical data, supplemented with some manually abstracted data. Future work could use this timeline to evaluate adherence to status epilepticus clinical protocols. PMID:26518205

  18. Developing a guideline for clinical trial protocol content: Delphi consensus survey

    Directory of Open Access Journals (Sweden)

    Tetzlaff Jennifer

    2012-09-01

    Full Text Available Abstract Background Recent evidence has highlighted deficiencies in clinical trial protocols, having implications for many groups. Existing guidelines for randomized clinical trial (RCT protocol content vary substantially and most do not describe systematic methodology for their development. As one of three prespecified steps for the systematic development of a guideline for trial protocol content, the objective of this study was to conduct a three-round Delphi consensus survey to develop and refine minimum content for RCT protocols. Methods Panellists were identified using a multistep iterative approach, met prespecified minimum criteria and represented key stakeholders who develop or use clinical trial protocols. They were asked to rate concepts for importance in a minimum set of items for RCT protocols. The main outcome measures were degree of importance (scale of 1 to 10; higher scores indicating higher importance and level of consensus for items. Results were presented as medians, interquartile ranges, counts and percentages. Results Ninety-six expert panellists participated in the Delphi consensus survey including trial investigators, methodologists, research ethics board members, funders, industry, regulators and journal editors. Response rates were between 88 and 93% per round. Overall, panellists rated 63 of 88 concepts of high importance (of which 50 had a 25th percentile rating of 8 or greater, 13 of moderate importance (median 6 or 7 and 12 of low importance (median less than or equal to 5 for minimum trial protocol content. General and item-specific comments and subgroup results provided valuable insight for further discussions. Conclusions This Delphi process achieved consensus from a large panel of experts from diverse stakeholder groups on essential content for RCT protocols. It also highlights areas of divergence. These results, complemented by other empirical research and consensus meetings, are helping guide the development of

  19. Development of a Clinical Protocol for Home Hospice Care for Koreans

    OpenAIRE

    Lee, Won-Hee; Lee, Chang-Geol

    2005-01-01

    As the Korean government's recognition of the importance of hospice service grows, the government has initiated a variety of hospice services in Korea. Each hospice organization has shown a significant difference in its health care delivery methods, constitution and care content. Developing a clinical protocol is essential for establishing standardized hospice services. A preliminary protocol was drawn up by examining the records of terminal patients (n=541) in a home hospice organization whi...

  20. Clinical validation protocols for noninvasive blood pressure monitors and their recognition by regulatory authorities and professional organizations: rationale and considerations for a single unified protocol or standard.

    Science.gov (United States)

    Ng, Kim-Gau

    2013-10-01

    Standardized protocols for validating the clinical accuracy of noninvasive blood pressure (NIBP) monitors have been available since 1987. Some of them were developed by standards bodies and others by professional organizations. They have been well-tested through use and progressively improved through multiple revisions; however, many methodological differences exist between them. In addition, for the purpose of regulatory approval or marketing clearance, some protocols are recognized in some countries but not in others; thus, manufacturers have to validate their NIBP monitors to more than one protocol in order to market them worldwide. The use of different protocols not only makes it difficult to compare one device with another but also complicates the validation, regulatory approval, marketing, and public acceptance of NIBP monitors, creating undue burden on manufacturers and unnecessary confusion among users. There is a need for protocol developers, standards bodies, and regulatory authorities to work together to develop and agree on a single unified protocol or standard, one that builds on the strengths of the various protocols that have been developed so far. It is apparent that there is already a trend toward convergence of the various protocols into two protocols, namely, the ISO 81060-2:2009 standard and the 2010 European Society of Hypertension International Protocol. With further reconciliation and consensus, it should be possible to integrate the best features of the ISO, European Society of Hypertension, and other protocols, along with further improvements, into a single unified protocol or standard. PMID:23709002

  1. Clinical and regulatory protocols for the management of impaired vision in the public health care network

    Directory of Open Access Journals (Sweden)

    Jayter Silva Paula

    2011-06-01

    Full Text Available PURPOSE: To describe the procedures used in developing Clinical and Regulatory Protocols for primary care teams to use in the management of the most common scenarios of impaired vision in Southern Brazil. METHODS: A retrospective review of 1.333 referral forms from all primary care practitioners was performed in Ribeirão Preto city, during a 30-day period. The major ophthalmic diagnostic categories were evaluated from those referrals forms. The Clinical and Regulatory Protocols development process was held afterwards and involved scientific cooperation between a university and the health care system, in the form of workshops attended by primary care practitioners and regulatory system team members composed of health care administrators, ophthalmologists, and professors of ophthalmology and social medicine. RESULTS: The management of impaired vision was chosen as the theme, since it accounted for 43.6% of the ophthalmology-related referrals from primary care providers of Ribeirão Preto. The Clinical and Regulatory Protocols developed involve distinctive diagnostic and therapeutic interventions that can be performed at the primary care level and in different health care settings. The most relevant clinical and regulatory interventions were expressed as algorithms in order to facilitate the use of the Clinical and Regulatory Protocols by health care practitioners. CONCLUSIONS: These Clinical and Regulatory Protocols could represent a useful tool for health systems with universal access, as well as for health care networks based on primary care and for regulatory system teams. Implementation of these Clinical and Regulatory Protocols can minimize the disparity between the needs of patients with impaired vision and the treatment modalities offered, resulting in a more cooperative health care network.

  2. Guiding principles of clinical research on mild cognitive impairment (protocol

    Directory of Open Access Journals (Sweden)

    Jin-zhou TIAN

    2008-01-01

    Full Text Available ABSTRACT: Mild cognitive impairment (MCI, as a nosological entity referring to elderly people with MCI but without dementia, was proposed as a warning signal of dementia occurrence and a novel therapeutic target. MCI clinical criteria and diagnostic procedure from the MCI Working Group of the European Alzheimer's Disease Consortium (EADC may better reflect the heterogeneity of MCI syndrome. Beijing United Study Group on MCI funded by the Capital Foundation of Medical Developments (CFMD proposed the guiding principles of clinical research on MCI. The diagnostic methods include clinical, neuropsychological, functional, neuroimaging and genetic measures. The diagnostic procedure includes three stages. Firstly, MCI syndrome must be defined, which should correspond to: (1 cognitive complaints coming from the patients or their families; (2 reporting of a relative decline in cognitive functioning during the past year by the patient or informant; (3 cognitive disorders evidenced by clinical evaluation; (4 activities of daily living preserved and complex instrumental functions either intact or minimally impaired; and (5 absence of dementia. Secondly, subtypes of MCI have to be recognized as amnestic MCI (aMCI, single non-memory MCI (snmMCI and multiple-domains MCI (mdMCI. Finally, the subtype causes could be identified commonly as Alzheimer disease (AD, vascular dementia (VaD, and other degenerative diseases such as frontal-temporal dementia (FTD, Lewy body disease (LBD, semantic dementia (SM, as well as trauma, infection, toxicity and nutrition deficiency. The recommended special tests include serum vitamin B12 and folic acid, plasma insulin, insulin-degrading enzyme, Aβ40, Aβ42, inflammatory factors. Computed tomography (or preferentially magnetic resonance imaging, when available is mandatory. As measurable therapeutic outcomes, the primary outcome should be the probability of progression to dementia, the secondary outcomes should be cognition and

  3. Economic evaluation of a clinical protocol for diagnosing emergency patients with suspected pulmonary embolism

    Directory of Open Access Journals (Sweden)

    Wolfe Rory

    2006-06-01

    Full Text Available Abstract Background The objective of this paper is to estimate the amount of cost-savings to the Australian health care system from implementing an evidence-based clinical protocol for diagnosing emergency patients with suspected pulmonary embolism (PE at the Emergency department of a Victorian public hospital with 50,000 presentations in 2001–2002. Methods A cost-minimisation study used the data collected in a controlled clinical trial of a clinical protocol for diagnosing patients with suspected PE. Thenumber and type of diagnostic tests in a historic cohort of 185 randomly selected patients, who presented to the emergency department with suspectedPE during an eight month period prior to the clinical trial (January 2002 -August 2002 were compared with the number and type of diagnostic tests in745 patients, who presented to the emergency department with suspected PE from November 2002 to August 2003. Current Medicare fees per test were usedas unit costs to calculate the mean aggregated cost of diagnostic investigation per patient in both study groups. A t-test was used to estimate the statistical significance of the difference in the cost of resources used for diagnosing PE in the control and in the intervention group. Results The trial demonstrated that diagnosing PE using an evidence-based clinical protocol was as effective as the existing clinical practice. The clinical protocol offers the advantage of reducing the use of diagnostic imaging, resulting in an average cost savings of at least $59.30 per patient. Conclusion Extrapolating the observed cost-savings of $59.30 per patient to the wholeof Australia could potentially result in annual savings between $3.1 million to $3.7 million.

  4. Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.

    Directory of Open Access Journals (Sweden)

    Anette Blümle

    Full Text Available BACKGROUND: Many clinical studies are ultimately not fully published in peer-reviewed journals. Underreporting of clinical research is wasteful and can result in biased estimates of treatment effect or harm, leading to recommendations that are inappropriate or even dangerous. METHODS: We assembled a cohort of clinical studies approved 2000-2002 by the Research Ethics Committee of the University of Freiburg, Germany. Published full articles were searched in electronic databases and investigators contacted. Data on study characteristics were extracted from protocols and corresponding publications. We characterized the cohort, quantified its publication outcome and compared protocols and publications for selected aspects. RESULTS: Of 917 approved studies, 807 were started and 110 were not, either locally or as a whole. Of the started studies, 576 (71% were completed according to protocol, 128 (16% discontinued and 42 (5% are still ongoing; for 61 (8% there was no information about their course. We identified 782 full publications corresponding to 419 of the 807 initiated studies; the publication proportion was 52% (95% CI: 0.48-0.55. Study design was not significantly associated with subsequent publication. Multicentre status, international collaboration, large sample size and commercial or non-commercial funding were positively associated with subsequent publication. Commercial funding was mentioned in 203 (48% protocols and in 205 (49% of the publications. In most published studies (339; 81% this information corresponded between protocol and publication. Most studies were published in English (367; 88%; some in German (25; 6% or both languages (27; 6%. The local investigators were listed as (co-authors in the publications corresponding to 259 (62% studies. CONCLUSION: Half of the clinical research conducted at a large German university medical centre remains unpublished; future research is built on an incomplete database. Research resources are

  5. Adoption of the children's obesity clinic's treatment (TCOCT) protocol into another Danish pediatric obesity treatment clinic

    DEFF Research Database (Denmark)

    Most, Sebastian W; Højgaard, Birgitte; Teilmann, Grete Katrine;

    2015-01-01

    BACKGROUND: Treating severe childhood obesity has proven difficult with inconsistent treatment results. This study reports the results of the implementation of a childhood obesity chronic care treatment protocol. METHODS: Patients aged 5 to 18 years with a body mass index (BMI) above the 99th......, but independent of baseline BMI SDS, age, co-morbidity, SES, pubertal stage, place of referral, hours of treatment per year, and mean visit interval time. CONCLUSIONS: The systematic use of the TCOCT protocol reduced the degree of childhood obesity with acceptable retention rates with a modest time...

  6. Coronectomy of mandibular third molars: A clinical protocol to avoid inferior alveolar nerve injury.

    Science.gov (United States)

    Monaco, Giuseppe; Vignudelli, Elisabetta; Diazzi, Michele; Marchetti, Claudio; Corinaldesi, Giuseppe

    2015-10-01

    Coronectomy is a surgical procedure for the treatment of mandibular third molars in close proximity to the mandibular canal. Unfortunately, often the surgical protocol is not described step by step and it is difficult for the clinician to assess the key factors that are important for the success of this procedure. The aim of this paper is to propose and describe a standardized surgical protocol to improve the success of the technique. The treatment approach, for the most common types of third molars impaction is analysed. Each step of the surgical procedure is described in details and a new type of crown section is proposed. The presented protocol is proposed in order to define a clinical practitioner's guide that could help the surgeon who approaches coronectomy for the first times. PMID:26321069

  7. Comparison of Eligibility Criteria Between Protocols, Registries, and Publications of Cancer Clinical Trials.

    Science.gov (United States)

    Zhang, Sheng; Liang, Fei; Li, Wenfeng; Tannock, Ian

    2016-11-01

    Trial registration and public accessibility of appended or published protocols of phase III randomized clinical trials (RCTs) allow comparison of reported research with essential aspects of trial design. We determined how eligibility criteria of participants specified in protocols were described in trial registries and articles of 255 cancer RCTs published in leading journals. The mean proportion of matching eligibility criteria between protocols and publications per trial (the primary endpoint) was 44.0% (95% confidence interval [CI] = 40.8% to 47.3%). Almost all discrepancies in eligibility criteria (96.7%, 95% CI = 96.1% to 97.3%) suggested to readers of articles that a broader study population was included. The mean proportion of matching eligibility criteria between protocols and registries was 72.9% (95% CI = 68.2% to 77.7%, the secondary endpoint). We conclude that there are substantial differences in eligibility criteria between trial protocols, registries and articles. Inaccurate reporting of eligibility criteria may prevent appropriate assessment of the applicability of trial results. PMID:27226519

  8. Hearing screening procedures and protocols in use at immunisation clinics in South Africa

    Directory of Open Access Journals (Sweden)

    Luisa Petrocchi-Bartal

    2014-06-01

    Full Text Available Background: There exists a need for context-relevant research aimed at facilitating the efficacious provision of early hearing detection and intervention services in South Africa.Objectives: This study aimed to determine the hearing screening procedures and protocols as well as referral protocols in use at maternal child woman’s health (MCWH immunisation clinics in South Africa.Method: Thirty primary health care immunisation clinic managers or acting managers were interviewed in two South African sample groups. An exploratory, non-experimental,qualitative research design was employed incorporating both quantitative and qualitative information. An interview using a questionnaire was administered with all participants. The questionnaire encompassed areas such as work contexts, hearing screening contexts and information management systems, as well as quality control measures in place at these clinics.Content analysis was then used to code emergent themes into specific categories. Frequency calculations of these themes were calculated and results described qualitatively.Results: No primary health care (PHC clinics placed within the identified sites provided formalised new-born/infant hearing screening and none of these facilities had equipment to do so. Most sites attributed the lack of formalised hearing screening to budgetary and human resource issues, staff training in particular. Non-formalised hearing screening protocols in place demonstrated inconsistencies in application across districts and none complied with Health Professions Council of South Africa (HPCSA clinic guidelines or any international guidelines.Conclusion: Results from the current study have assisted in identifying procedural and logistical assets and barriers to implementation of HPCSA clinic guidelines for early hearing detection and intervention (EHDI at immunisation clinics in South Africa.

  9. Whole Body Vibration Exercise Protocol versus a Standard Exercise Protocol after ACL Reconstruction: A Clinical Randomized Controlled Trial with Short Term Follow-Up

    Directory of Open Access Journals (Sweden)

    Gereon Berschin

    2014-09-01

    Full Text Available The suitability and effectiveness of whole body vibration (WBV exercise in rehabilitation after injury of the anterior cruciate ligament (ACL was studied using a specially designed WBV protocol. We wanted to test the hypothesis if WBV leads to superior short term results regarding neuromuscular performance (strength and coordination and would be less time consuming than a current standard muscle strengthening protocol. In this prospective randomized controlled clinical trial, forty patients who tore their ACL and underwent subsequent ligament reconstruction were enrolled. Patients were randomized to the whole body vibration (n=20 or standard rehabilitation exercise protocol (n=20. Both protocols started in the 2nd week after surgery. Isometric and isokinetic strength measurements, clinical assessment, Lysholm score, neuromuscular performance were conducted weeks 2, 5, 8 and 11 after surgery. Time spent for rehabilitation exercise was reduced to less than a half in the WBV group. There were no statistically significant differences in terms of clinical assessment, Lysholm score, isokinetic and isometric strength. The WBV group displayed significant better results in the stability test. In conclusion, preliminary data indicate that our whole body vibration muscle exercise protocol seems to be a good alternative to a standard exercise program in ACL-rehabilitation. Despite of its significant reduced time requirement it is at least equally effective compared to a standard rehabilitation protocol.

  10. Replacement of missing teeth with fiber-reinforced composite FPDs: clinical protocol

    OpenAIRE

    Bouillaguet, Serge; Schütt, Andrea; Marin, Isabelle; Etechami, Leila; Di Salvo, Giancarlo; Krejci, Ivo

    2003-01-01

    The concept of minimally invasive preparation protocols has resulted in reduced loss of critical tooth structures and maintenance of optimal strength, form, and aesthetics. While various treatment options have been described for single-tooth replacement, fiber-reinforced composite (FRC) fixed partial dentures (FPDs) provide a viable treatment alternative with proven mechanical properties, aesthetics, and function. This article presents several clinical scenarios in which minimally invasive ad...

  11. Physical and clinical implications of radiotherapy treatment of prostate cancer using a full bladder protocol

    Energy Technology Data Exchange (ETDEWEB)

    Cambria, Raffaella; Cattani, Federica; Luraschi, Rosa; Pedroli, Guido [Istituto Europeo di Oncologia, Milan (Italy). Dept. of Medical Physics; Jereczek-Fossa, Barbara A.; Orecchia, Roberto [Istituto Europeo di Oncologia, Milan (Italy). Dept. of Radiation Oncology; Univ. degli Studi of Milano, Milan (Italy); Zerini, Dario [Istituto Europeo di Oncologia, Milan (Italy). Dept. of Radiation Oncology; Serafini, Flavia [Unita operativa di radioterapia, Azienda Ospedaliera Sant' Anna, Como (Italy)

    2011-12-15

    To assess the dosimetric and clinical implication when applying the full bladder protocol for the treatment of the localized prostate cancer (PCA). A total of 26 consecutive patients were selected for the present study. Patients underwent two series of CT scans: the day of the simulation and after 40 Gy. Each series consisted of two consecutive scans: (1) full bladder (FB) and (2) empty bladder (EB). The contouring of clinical target volumes (CTVs) and organs at risk (OAR) were compared to evaluate organ motion. Treatment plans were compared by dose distribution and dose-volume histograms (DVH). CTV shifts were negligible in the laterolateral and superior-inferior directions (the maximum shift was 1.85 mm). Larger shifts were recorded in the anterior-posterior direction (95% CI, 0.83-4.41 mm). From the dosimetric point of view, shifts are negligible: the minimum dose to the CTV was 98.5% (median; 95%CI, 95-99%). The potential advantage for GU toxicity in applying the FB treatment protocol was measured: the ratio between full and empty bladder dose-volume points (selected from our protocol) is below 0.61, excluding the higher dose region where DVHs converge. Having a FB during radiotherapy does not affect treatment effectiveness, on the contrary it helps achieve a more favorable DVH and lower GU toxicities.

  12. The effect of a preoperative erythropoietin protocol as part of a multifaceted blood management program in daily clinical practice (CME)

    NARCIS (Netherlands)

    Doodeman, Hieronymus J.; van Haelst, Ingrid M. M.; Egberts, Toine C. G.; Bennis, Martin; Traast, Han S.; van Solinge, Wouter W.; Kalkman, Cor J.; van Klei, Wilton A.

    2013-01-01

    Background: The effectiveness of a preoperative erythropoietin (EPO) protocol to reduce allogeneic blood transfusions (ABTs) in daily clinical practice has been insufficiently studied. This study evaluated the effect of such a protocol, as part of a multifaceted blood management program, in patients

  13. Telephone care coordination for smokers in VA mental health clinics: protocol for a hybrid type-2 effectiveness-implementation trial

    OpenAIRE

    Rogers, Erin; Fernandez, Senaida; Gillespie, Colleen; Smelson, David; Hagedorn, Hildi J; Elbel, Brian; Kalman, David; Axtmayer, Alfredo; Kurowski, Karishma; Sherman, Scott E

    2013-01-01

    Background This paper describes an innovative protocol for a type-II hybrid effectiveness-implementation trial that is evaluating a smoking cessation telephone care coordination program for Veterans Health Administration (VA) mental-health clinic patients. As a hybrid trial, the protocol combines implementation science and clinical trial methods and outcomes that can inform future cessation studies and the implementation of tobacco cessation programs into routine care. The primary objectives ...

  14. Summary of ongoing clinical protocols for proton and heavier-ion therapy

    International Nuclear Information System (INIS)

    Since 1954 when the very first patient was treated at LBNL with heavy-charged particles, some 84,000 patients in total have now been treated with protons, and another 13,000 patients have been treated with carbon and other heavier ions. During the first several decades of this endeavor, particle therapy was accessible only at a small number of programs. More recently, however, this therapy has become available at a rapidly increasing number of facilities worldwide. This expansion of the discipline has led to the development of many more clinical trials, designed to optimize particle-beam therapy and to compare the results achieved with those resulting from other treatment methods. Presently, more than 50 clinical protocols worldwide are actively involved in the effort to improve our understanding of these clinical guidelines. The purpose of this brief review is to offer a broad overview of these protocols, highlighting the specific disease categories that are now being studied using proton and/or heavier-ion therapy, and how the parameters of dose-escalation, beam conformity, and RBE modeling are being evaluated for various disease sites and stages.

  15. Systematic review about data quality and protocol compliance in clinical trials

    Directory of Open Access Journals (Sweden)

    Strenge-Hesse, Anke

    2008-02-01

    Full Text Available For Investigator Initiated Trials (IITs alternative risk-adapted monitoring strategies are discussed in order to fulfill rules and regulations, taking into consideration the restricted resources. In this systematic review investigations, presenting quantitative data about data quality and protocol compliance in clinical trials, are analyzed. The results are discussed taking into account the quality assurance procedures implemented. Based on a systematic MEDLINE retrieval, 21 studies could be identified in which data and process quality in clinical trials were investigated and assessed by site visits with source data verification or review of copied source data in the study center and quantitative information about data quality and protocol compliance was available. The majority of investigations were performed by three organizations: European Organization for Research and Treatment of Cancer (EORTC (n=7, National Cancer Institute (NCI (n=7 and investigations of the Trans-Tasman Radiation Oncology Group (TROG (n=4. In addition three investigations of other study groups were identified. The investigations were published between 1981 and 2003. In the majority of cases oncological trials were investigated (n=19 with a focus on radiotherapy trials (n=8. In the EORTC-trials an overall good data quality was assessed (80–90% correct data. Singular problems were found with respect to protocol compliance and reporting of adverse reactions and serious unexpected events. Good quality was also observed with respect to the correct inclusion of patients into trials. By the NCI a standardized audit system was introduced and implemented within cooperative study groups. In the context of these audits different criteria were assessed and a good data quality and protocol compliance were measured. Deficits occurred in about 5% of the cases with respect to informed consent, correct application of inclusion criteria, protocol compliance, assessment of outcome

  16. Dynamic whole-body PET parametric imaging: I. Concept, acquisition protocol optimization and clinical application

    International Nuclear Information System (INIS)

    Static whole-body PET/CT, employing the standardized uptake value (SUV), is considered the standard clinical approach to diagnosis and treatment response monitoring for a wide range of oncologic malignancies. Alternative PET protocols involving dynamic acquisition of temporal images have been implemented in the research setting, allowing quantification of tracer dynamics, an important capability for tumor characterization and treatment response monitoring. Nonetheless, dynamic protocols have been confined to single-bed-coverage limiting the axial field-of-view to ∼15–20 cm, and have not been translated to the routine clinical context of whole-body PET imaging for the inspection of disseminated disease. Here, we pursue a transition to dynamic whole-body PET parametric imaging, by presenting, within a unified framework, clinically feasible multi-bed dynamic PET acquisition protocols and parametric imaging methods. We investigate solutions to address the challenges of: (i) long acquisitions, (ii) small number of dynamic frames per bed, and (iii) non-invasive quantification of kinetics in the plasma. In the present study, a novel dynamic (4D) whole-body PET acquisition protocol of ∼45 min total length is presented, composed of (i) an initial 6 min dynamic PET scan (24 frames) over the heart, followed by (ii) a sequence of multi-pass multi-bed PET scans (six passes × seven bed positions, each scanned for 45 s). Standard Patlak linear graphical analysis modeling was employed, coupled with image-derived plasma input function measurements. Ordinary least squares Patlak estimation was used as the baseline regression method to quantify the physiological parameters of tracer uptake rate Ki and total blood distribution volume V on an individual voxel basis. Extensive Monte Carlo simulation studies, using a wide set of published kinetic FDG parameters and GATE and XCAT platforms, were conducted to optimize the acquisition protocol from a range of ten different clinically

  17. Dynamic whole-body PET parametric imaging: I. Concept, acquisition protocol optimization and clinical application

    Science.gov (United States)

    Karakatsanis, Nicolas A.; Lodge, Martin A.; Tahari, Abdel K.; Zhou, Y.; Wahl, Richard L.; Rahmim, Arman

    2013-10-01

    Static whole-body PET/CT, employing the standardized uptake value (SUV), is considered the standard clinical approach to diagnosis and treatment response monitoring for a wide range of oncologic malignancies. Alternative PET protocols involving dynamic acquisition of temporal images have been implemented in the research setting, allowing quantification of tracer dynamics, an important capability for tumor characterization and treatment response monitoring. Nonetheless, dynamic protocols have been confined to single-bed-coverage limiting the axial field-of-view to ˜15-20 cm, and have not been translated to the routine clinical context of whole-body PET imaging for the inspection of disseminated disease. Here, we pursue a transition to dynamic whole-body PET parametric imaging, by presenting, within a unified framework, clinically feasible multi-bed dynamic PET acquisition protocols and parametric imaging methods. We investigate solutions to address the challenges of: (i) long acquisitions, (ii) small number of dynamic frames per bed, and (iii) non-invasive quantification of kinetics in the plasma. In the present study, a novel dynamic (4D) whole-body PET acquisition protocol of ˜45 min total length is presented, composed of (i) an initial 6 min dynamic PET scan (24 frames) over the heart, followed by (ii) a sequence of multi-pass multi-bed PET scans (six passes × seven bed positions, each scanned for 45 s). Standard Patlak linear graphical analysis modeling was employed, coupled with image-derived plasma input function measurements. Ordinary least squares Patlak estimation was used as the baseline regression method to quantify the physiological parameters of tracer uptake rate Ki and total blood distribution volume V on an individual voxel basis. Extensive Monte Carlo simulation studies, using a wide set of published kinetic FDG parameters and GATE and XCAT platforms, were conducted to optimize the acquisition protocol from a range of ten different clinically

  18. Barriers and strategies for the clinical translation of advanced orthopaedic tissue engineering protocols

    Directory of Open Access Journals (Sweden)

    H Madry

    2014-05-01

    Full Text Available Research in orthopaedic tissue engineering has intensified over the last decade and new protocols continue to emerge. The clinical translation of these new applications, however, remains associated with a number of obstacles. This report highlights the major issues that impede the clinical translation of advanced tissue engineering concepts, discusses strategies to overcome these barriers, and examines the need to increase incentives for translational strategies. The statements are based on presentations and discussions held at the AO Foundation-sponsored symposium "Where Science meets Clinics 2013" held at the Congress Center in Davos, Switzerland, in September, 2013. The event organisers convened a diverse group of over one hundred stakeholders involved in clinical translation of orthopaedic tissue engineering, including scientists, clinicians, healthcare industry professionals and regulatory agency representatives. A major point that emerged from the discussions was that there continues to be a critical need for early trans-disciplinary communication and collaboration in the development and execution of research approaches. Equally importantly was the need to address the shortage of sustained funding programs for multidisciplinary teams conducting translational research. Such detailed discussions between experts contribute towards the development of a roadmap to more successfully advance the clinical translation of novel tissue engineering concepts and ultimately improve patient care in orthopaedic and trauma surgery.

  19. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials.

    Directory of Open Access Journals (Sweden)

    Benjamin Kasenda

    2016-06-01

    Full Text Available Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i the existence and types of publication agreements in trial protocols, (ii the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii the frequency of co-authorship by industry employees.We used a retrospective cohort of randomized clinical trials (RCTs based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5% mentioned an agreement regarding publication of results. Of these 456, 393 (86.2% documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6% agreements were without constraints of publication. The remaining 24 (5.3% protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0% trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]. Of 71 agreements reported in publications, 52 (73.2% were concordant with those documented in the protocol. In 14 of 37 (37.8% publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements.Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do

  20. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials

    Science.gov (United States)

    Kasenda, Benjamin; von Elm, Erik; You, John J.; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J.; Stegert, Mihaela; Olu, Kelechi K.; Tikkinen, Kari A. O.; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M.; Mertz, Dominik; Akl, Elie A.; Bassler, Dirk; Busse, Jason W.; Nordmann, Alain; Gloy, Viktoria; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O.; Johnston, Bradley C.; Walter, Martin A.; Burnand, Bernard; Hemkens, Lars G.; Bucher, Heiner C.; Guyatt, Gordon H.; Briel, Matthias

    2016-01-01

    Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner’s right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions Publication agreements constraining academic authors’ independence are common. Journal articles seldom report on

  1. Poster — Thur Eve — 20: CTDI Measurements using a Radiochromic Film-based clinical protocol

    International Nuclear Information System (INIS)

    The purpose of the study was evaluating accuracy and reproducibility of a radiochromic film-based protocol to measure computer tomography dose index (CTDI) as a part of annual QA on CT scanners and kV-CBCT systems attached to linear accelerators. Energy dependence of Gafchromic XR-QA2 ® film model was tested over imaging beam qualities (50 – 140 kVp). Film pieces were irradiated in air to known values of air-kerma (up to 10 cGy). Calibration curves for each beam quality were created (Film reflectance change Vs. Air-kerma in air). Film responses for same air-kerma values were compared. Film strips were placed into holes of a CTDI phantom and irradiated for several clinical scanning protocols. Film reflectance change was converted into dose to water and used to calculate CTDIvol values. Measured and tabulated CTDIvol values were compared. Average variations of ±5.2% in the mean film reflectance change were observed in the energy range of 80 to 140 keV, and 11.1% between 50 and 140 keV. Measured CTDI values were in average 10% lower than tabulated CTDI values for CT-simulators, and 44% higher for CBCT systems. Results presented a mean variation for the same machine and protocol of 2.6%. Variation of film response is within ±5% resulting in ±15% systematic error in dose estimation if a single calibration curve is used. Relatively large discrepancy between measured and tabulated CTDI values strongly support the trend towards replacing CTDI value with equilibrium dose measurement in the center of cylindrical phantom, as suggested by TG- 111

  2. Poster — Thur Eve — 20: CTDI Measurements using a Radiochromic Film-based clinical protocol

    Energy Technology Data Exchange (ETDEWEB)

    Quintero, C.; Bekerat, H.; DeBlois, F. [Medical Physics Unit, McGill University. Montreal, Quebec (Canada); Department of Radiation Oncology, SMBD Jewish General Hospital, McGill University. Montreal, Quebec (Canada); Tomic, N.; Devic, S. [Department of Radiation Oncology, SMBD Jewish General Hospital, McGill University. Montreal, Quebec (Canada); Seuntjens, J. [Medical Physics Unit, McGill University. Montreal, Quebec (Canada)

    2014-08-15

    The purpose of the study was evaluating accuracy and reproducibility of a radiochromic film-based protocol to measure computer tomography dose index (CTDI) as a part of annual QA on CT scanners and kV-CBCT systems attached to linear accelerators. Energy dependence of Gafchromic XR-QA2 ® film model was tested over imaging beam qualities (50 – 140 kVp). Film pieces were irradiated in air to known values of air-kerma (up to 10 cGy). Calibration curves for each beam quality were created (Film reflectance change Vs. Air-kerma in air). Film responses for same air-kerma values were compared. Film strips were placed into holes of a CTDI phantom and irradiated for several clinical scanning protocols. Film reflectance change was converted into dose to water and used to calculate CTDIvol values. Measured and tabulated CTDIvol values were compared. Average variations of ±5.2% in the mean film reflectance change were observed in the energy range of 80 to 140 keV, and 11.1% between 50 and 140 keV. Measured CTDI values were in average 10% lower than tabulated CTDI values for CT-simulators, and 44% higher for CBCT systems. Results presented a mean variation for the same machine and protocol of 2.6%. Variation of film response is within ±5% resulting in ±15% systematic error in dose estimation if a single calibration curve is used. Relatively large discrepancy between measured and tabulated CTDI values strongly support the trend towards replacing CTDI value with equilibrium dose measurement in the center of cylindrical phantom, as suggested by TG- 111.

  3. Three-dimensional methodology for photogrammetric acquisition of the soft tissues of the face: a new clinical-instrumental protocol

    OpenAIRE

    Deli, Roberto; Galantucci, Luigi M; Laino, Alberto; D’Alessio, Raoul; Di Gioia, Eliana; Savastano, Carmela; Lavecchia, Fulvio; Percoco, Gianluca

    2013-01-01

    Background The objective of this study is to define an acquisition protocol that is clear, precise, repeatable, simple, fast and that is useful for analysis of the anthropometric characteristics of the soft tissue of the face. Methods The analysis was carried out according to a new clinical-instrumental protocol that comprises four distinct phases: (1) setup of portable equipment in the space in which field analysis will be performed, (2) preparation of the subject and spatial positioning, (3...

  4. Contributions to variability of clinical measures for use as indicators of udder health status in a clinical protocol

    Directory of Open Access Journals (Sweden)

    Houe H

    2006-08-01

    Full Text Available Abstract A cross-sectional observational study with repeated observations was conducted on 16 Danish dairy farms to quantify the influence of observer, parity, time (stage in lactation and farm on variables routinely selected for inclusion in clinical protocols, thereby to enable a more valid comparison of udder health between different herds. During 12 months, participating herds were visited 5 times by project technicians, who examined 20 cows and scored the selected clinical variables. The estimates of effect on variables were derived from a random regression model procedure. Statistical analyses revealed that, although estimates for occurrence of several the variables, e.g. degree of oedema, varied significantly between observers, the effects on many of these estimates were similar in size. Almost all estimates for occurrences of variables were significantly affected either parity and lactation stage, or by both e.g. udder tissue consistency. Some variables, e.g. mange, had high estimates for the farm component, and others e.g. teat skin quality had a high individual component. Several of the variables, e.g. wounds on warts, had a high residual component indicating that a there still was a major part of the variation in data, which was unexplained. It was concluded that most of the variables were relevant for implementation in herd health management, but that adjustments need to be made to improve reliability.

  5. Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

    Directory of Open Access Journals (Sweden)

    Melanie Calvert

    Full Text Available Evidence suggests there are inconsistencies in patient-reported outcome (PRO assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013 for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts. 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3% recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in

  6. Alternative Physical Therapy Protocol Using a Cycle Ergometer During Hospital Rehabilitation of Coronary Artery Bypass Grafting: a Clinical Trial

    Directory of Open Access Journals (Sweden)

    Margarete Diprat Trevisan

    2015-12-01

    Full Text Available ABSTRACT OBJECTIVE: To compare the efficacy of a cycle ergometer-based exercise program to a standard protocol on the increment of the maximum distance walked during the six-minute walk test in the postoperative rehabilitation of patients submitted to coronary artery bypass grafting. METHODS: A controlled clinical trial pilot, blinded to the outcome, enrolled subjects who underwent coronary artery bypass grafting in a hospital from Southern Brazil. Subjects were designated for the standard physical rehabilitation protocol or to an alternative cycle ergometer-based protocol through simple random sampling. The primary outcome was the difference in the maximum distance walked in the six-minute walk test before and after the allocated intervention. RESULTS: Twenty-four patients were included in the analysis, 10 in the standard protocol and 14 in the alternative protocol group. There was an increment in the maximum distance walked in both groups, and borderline superiority in the intervention group comparing to the control group (312.2vs. 249.7; P=0.06. CONCLUSION: There was an increase in the maximum distance walked in the alternative protocol compared to the standard protocol. Thus, it is postulated that the use of a cycle ergometer can be included in physical rehabilitation in the hospital phase of postoperative coronary artery bypass grafting. However, randomized studies with larger sample size should be conducted to assess the significance of these findings.

  7. Craniosacral therapy for migraine: Protocol development for an exploratory controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Coeytaux Remy R

    2008-06-01

    have withdrawn from the study after giving consent. Conclusion This report endorses the feasibility of undertaking a rigorous randomized clinical trial of CST for migraine using a standardized CST protocol and an innovative control protocol developed for the study. Subjects are able and willing to complete detailed headache diaries during an 8-week baseline period, with few dropouts during the study period, indicating the acceptability of both interventions. Trial Registration ClinicalTrials.gov NCT00665236

  8. Risks to the fetus from diagnostic imaging during pregnancy: review and proposal of a clinical protocol

    Energy Technology Data Exchange (ETDEWEB)

    Gomes, Mafalda; Matias, Alexandra [University of Porto, Faculty of Medicine, Porto (Portugal); Macedo, Filipe [SMIC, Porto (Portugal)

    2015-12-15

    Every day, medical practitioners face the dilemma of exposing pregnant or possibly pregnant patients to radiation from diagnostic examinations. Both doctors and patients often have questions about the risks of radiation. The most vulnerable period is between the 8th and 15th weeks of gestation. Deterministic effects like pregnancy loss, congenital malformations, growth retardation and neurobehavioral abnormalities have threshold doses above 100-200 mGy. The risk is considered negligible at 50 mGy and in reality no diagnostic examination exceeds this limit. The risk of carcinogenesis is slightly higher than in the general population. Intravenous iodinated contrast is discouraged, except in highly selected patients. Considering all the possible noxious effects of radiation exposure, measures to diminish radiation are essential and affect the fetal outcome. Nonionizing procedures should be considered whenever possible and every radiology center should have its own data analysis on fetal radiation exposure. In this review, we analyze existing literature on fetal risks due to radiation exposure, producing a clinical protocol to guide safe radiation use in a clinical setting. (orig.)

  9. Failure to report protocol violations in clinical trials: a threat to internal validity?

    Directory of Open Access Journals (Sweden)

    Doig Gordon S

    2011-09-01

    Full Text Available Abstract Background Excessive protocol violations (PV, which can be defined as preventable mistakes in study conduct, may result in patient harm and introduce errors into a clinical trial's results leading to flawed trial conclusions. The purpose of this project was to gain a better understanding of reported PVs, to describe current practice with regards to the use of methods for the reduction of PVs and to investigate relationships between clinical trial characteristics and PVs. Methods We reviewed 80 clinical trials conducted across a broad range of medical specialties published in four major general medical journals (The Lancet, NEJM, JAMA, BMJ. Eligible papers were identified using a PubMed search. For each included trial, two authors independently abstracted information on trial characteristics, PV reporting and PV rates and interventions used to reduce PVs. PVs were categorised into one of five distinct types: enrolment, randomisation, study intervention, patient compliance and data collection errors. Associations between PVs and study characteristics were investigated using logistic regression. Results Eighty clinical trials (20 from each journal were identified from 101 consecutive PubMed abstracts. The median number of participants was 701 (range: 20 to 162, 367 and the median number of participating sites was 15 (range: 1 to 701. Nineteen percent (15/80 of included trials were single centre trials. The median study duration was 24 months (range: 5.81 - 127 months and 74% (59/80 of included trials were primarily academic funded. Thirty two percent (26/80 of included trials failed to provide explicit reporting of any type of PV and none (0/80 of the trials provided explicit reporting of all five types of PVs. Larger clinical trials (more patients, more sites, longer duration, more complex management structure were more likely to have more complete reporting of PV's. Only 9% (7/80 of trials reported the use of a specific study method to

  10. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40

    Science.gov (United States)

    Boone, Margaret; Brown, Nancy J.; Moon, Mary A.; Schuman, Deborah J.; Thomas, Josephine; Wright, Denise L.

    2004-01-01

    This Treatment Improvement Protocol (TIP) addresses the clinical use of buprenorphine in the treatment of opioid addiction. TIPs are best-practice guidelines for the treatment of substance use disorders that make the latest research in substance abuse treatment available to counselors and educators. The content was generated by a panel of experts…

  11. Correction: PAIS: paracetamol (acetaminophen in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480

    Directory of Open Access Journals (Sweden)

    Kappelle L Jaap

    2008-11-01

    Full Text Available Abstract Background The Paracetamol (Acetaminophen In Stroke (PAIS study is a phase III multicenter, double blind, randomized, placebo-controlled clinical trial of high-dose acetaminophen in patients with acute stroke. The trial compares treatment with a daily dose of 6 g acetaminophen, started within 12 hours after the onset of symptoms, with matched placebo. The purpose of this study is to assess whether treatment with acetaminophen for 3 days will result in improved functional outcome through a modest reduction in body temperature and prevention of fever. The previously planned statistical analysis based on a dichotomization of the scores on the modified Rankin Scale (mRS may not make the most efficient use of the available baseline information. Therefore, the planned primary analysis of the PAIS study has been changed from fixed dichotomization of the mRS to a sliding dichotomy analysis. Methods Instead of taking a single definition of good outcome for all patients, the definition is tailored to each individual patient's baseline prognosis on entry into the trial. Conclusion The protocol change was initiated because of both advances in statistical approaches and to increase the efficiency of the trial by improving statistical power. Trial Registration Current Controlled Trials [ISCRTN74418480

  12. Mindfulness for irritable bowel syndrome: protocol development for a controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Garland Eric L

    2009-07-01

    Full Text Available Abstract Background Irritable bowel syndrome (IBS, a functional bowel disorder with symptoms of abdominal pain and disturbed defecation experienced by 10% of U.S. adults, results in significant disability, impaired quality of life, and health-care burden. Conventional medical care focusing on pharmacological approaches, diet, and lifestyle management has been partially effective in controlling symptoms. Behavioral treatments, such as cognitive-behavioral therapy and hypnosis, are promising. This paper describes an on-going feasibility study to assess the efficacy of mindfulness training, a behavioral treatment involving directing and sustaining attention to present-moment experience, for the treatment of IBS. Methods/Design The study design involves randomization of adult women with IBS according to Rome II criteria, to either an eight-week mindfulness training group (based on a Mindfulness-based Stress Reduction [MBSR] format or a previously validated IBS social-support group as an attention-control condition. The primary hypothesis is that, compared to Support Group participants, those in the Mindfulness Program will demonstrate significant improvement in IBS symptoms as measured by the IBS Symptom Severity Scale 1. Discussion 214 individuals have been screened for eligibility, of whom 148 were eligible for the study. Of those, 87 were enrolled, with 21 withdrawing after having given consent. 66 have completed or are in the process of completing the interventions. It is feasible to undertake a rigorous randomized clinical trial of mindfulness training for people with IBS, using a standardized MBSR protocol adapted for those experiencing IBS, compared to a control social-support group previously utilized in IBS studies. Trial Registration Clinical Trials.gov Identifier: NCT00680693

  13. Assessment of the clinical outcome of a symptom-based outpatient hyperglycemia protocol

    OpenAIRE

    Armor, Becky; Harrison, Don; Lawler, Frank

    2011-01-01

    Introduction Acute hyperglycemia (blood glucose [BG] ≥400 mg/dL) is common in primary care. An outpatient protocol was developed to streamline the treatment of acute hyperglycemia. The objective was to determine if an outpatient hyperglycemia protocol could achieve a BG level of 400 mg/dL) without acute illness were recruited. Enrolled patients were managed with a protocol that included administration of 0.15 units/kg rapid-acting insulin given subcutaneously, hydration, hourly fingerstick bl...

  14. Bringing memory fMRI to the clinic: comparison of seven memory fMRI protocols in temporal lobe epilepsy.

    Science.gov (United States)

    Towgood, Karren; Barker, Gareth J; Caceres, Alejandro; Crum, William R; Elwes, Robert D C; Costafreda, Sergi G; Mehta, Mitul A; Morris, Robin G; von Oertzen, Tim J; Richardson, Mark P

    2015-04-01

    fMRI is increasingly implemented in the clinic to assess memory function. There are multiple approaches to memory fMRI, but limited data on advantages and reliability of different methods. Here, we compared effect size, activation lateralisation, and between-sessions reliability of seven memory fMRI protocols: Hometown Walking (block design), Scene encoding (block design and event-related design), Picture encoding (block and event-related), and Word encoding (block and event-related). All protocols were performed on three occasions in 16 patients with temporal lobe epilepsy (TLE). Group T-maps showed activity bilaterally in medial temporal lobe for all protocols. Using ANOVA, there was an interaction between hemisphere and seizure-onset lateralisation (P = 0.009) and between hemisphere, protocol and seizure-onset lateralisation (P = 0.002), showing that the distribution of memory-related activity between left and right temporal lobes differed between protocols and between patients with left-onset and right-onset seizures. Using voxelwise intraclass Correlation Coefficient, between-sessions reliability was best for Hometown and Scenes (block and event). The between-sessions spatial overlap of activated voxels was also greatest for Hometown and Scenes. Lateralisation of activity between hemispheres was most reliable for Scenes (block and event) and Words (event). Using receiver operating characteristic analysis to explore the ability of each fMRI protocol to classify patients as left-onset or right-onset TLE, only the Words (event) protocol achieved a significantly above-chance classification of patients at all three sessions. We conclude that Words (event) protocol shows the best combination of between-sessions reliability of the distribution of activity between hemispheres and reliable ability to distinguish between left-onset and right-onset patients. PMID:25727386

  15. Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM).

    Science.gov (United States)

    Huser, Vojtech; Sastry, Chandan; Breymaier, Matthew; Idriss, Asma; Cimino, James J

    2015-10-01

    Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard. PMID:26188274

  16. Group differences in physician responses to handheld presentation of clinical evidence: a verbal protocol analysis

    Directory of Open Access Journals (Sweden)

    Pavlovic Nada J

    2007-07-01

    Full Text Available Abstract Background To identify individual differences in physicians' needs for the presentation of evidence resources and preferences for mobile devices. Methods Within-groups analysis of responses to semi-structured interviews. Interviews consisted of using prototypes in response to task-based scenarios. The prototypes were implemented on two different form factors: a tablet style PC and a pocketPC. Participants were from three user groups: general internists, family physicians and medicine residents, and from two different settings: urban and semi-urban. Verbal protocol analysis, which consists of coding utterances, was conducted on the transcripts of the testing sessions. Statistical relationships were investigated between staff physicians' and residents' background variables, self-reported experiences with the interfaces, and verbal code frequencies. Results 47 physicians were recruited from general internal medicine, family practice clinics and a residency training program. The mean age of participants was 42.6 years. Physician specialty had a greater effect on device and information-presentation preferences than gender, age, setting or previous technical experience. Family physicians preferred the screen size of the tablet computer and were less concerned about its portability. Residents liked the screen size of the tablet, but preferred the portability of the pocketPC. Internists liked the portability of the pocketPC, but saw less advantage to the large screen of the tablet computer (F[2,44] = 4.94, p = .012. Conclusion Different types of physicians have different needs and preferences for evidence-based resources and handheld devices. This study shows how user testing can be incorporated into the process of design to inform group-based customization.

  17. Getting started with protocol for quality assurance of digital mammography in the clinical centre of Montenegro.

    Science.gov (United States)

    Ivanovic, S; Bosmans, H; Mijovic, S

    2015-07-01

    The purpose of this work is (i) to work out a test procedure for quality assurance (QA) in digital mammography with newly released test equipment, including the MagicMax mam multimeter (IBA, Germany) and the anthropomorphic tissue equivalent phantom Mammo AT (IBA, Germany), and (ii) to determine whether a first digital computer radiography (CR) system in Montenegro meets the current European standards. Tested parameters were tube output (µGy mAs(-1)) and output rate (mGy s(-1)), reproducibility and accuracy of tube voltage, half value layer, reproducibility and accuracy of the AEC system, exposure control steps, image receptor's response function, image quality and printer stability test. The evaluated dosimetric quantity is the average glandular dose (AGD) as evaluated from PMMA slabs simulating breast tissue. The main findings are that QA can be organised in Montenegro. (1) All measured parameters are within the range described in European protocols except the tube voltage which deviated more than ± 1 kV. The automatic determination of the HVL was satisfactorily. AGD ranged from 0.66 to 7.02 mGy for PMMA thicknesses from 20 to 70 mm, and is in accordance with literature data. (2) The image quality score as obtained with the anthropomorphic tissue equivalent phantom Mammo AT for the CR system was similar to findings on the authors' conventional screen-film mammography. (3) In clinical practice the mammograms are printed. The CR reader produces images with a pixel size of 43.75 µm, which is compatible with the laser printer (39 µm laser spot spacing). The image processing algorithm embedded in the reader successfully processes mammograms with desirable image brightness and contrast in the printed image. The authors conclude that this first digital mammography system seems a good candidate for breast cancer screening applications. PMID:25862535

  18. Getting started with protocol for quality assurance of digital mammography in the clinical centre of Montenegro

    International Nuclear Information System (INIS)

    The purpose of this work is (i) to work out a test procedure for quality assurance (QA) in digital mammography with newly released test equipment, including the MagicMax mam multi-meter (IBA, Germany) and the anthropomorphic tissue equivalent phantom Mammo AT (IBA, Germany), and (ii) to determine whether a first digital computer radiography (CR) system in Montenegro meets the current European standards. Tested parameters were tube output (μGy mAs-1) and output rate (μGy s-1), reproducibility and accuracy of tube voltage, half value layer, reproducibility and accuracy of the AEC system, exposure control steps, image receptor's response function, image quality and printer stability test. The evaluated dosimetric quantity is the average glandular dose (AGD) as evaluated from PMMA slabs simulating breast tissue. The main findings are that QA can be organised in Montenegro. (1) All measured parameters are within the range described in European protocols except the tube voltage which deviated more than ±1 kV. The automatic determination of the HVL was satisfactorily. AGD ranged from 0.66 to 7.02 mGy for PMMA thicknesses from 20 to 70 mm, and is in accordance with literature data. (2) The image quality score as obtained with the anthropomorphic tissue equivalent phantom Mammo AT for the CR system was similar to findings on the authors' conventional screen-film mammography. (3) In clinical practice the mammograms are printed. The CR reader produces images with a pixel size of 43.75 μm, which is compatible with the laser printer (39 μm laser spot spacing). The image processing algorithm embedded in the reader successfully processes mammograms with desirable image brightness and contrast in the printed image. The authors conclude that this first digital mammography system seems a good candidate for breast cancer screening applications. (authors)

  19. [A protocol to assist people with suicidal thoughts in clinical practice].

    Science.gov (United States)

    Gagliesi, Pablo

    2010-01-01

    This article presents a Protocol for Suicidal Clients in mental health practice. These protocols in medicine should promote a practice based on evidence and the experts consensus. It discusses the advantages and disadvantages of this procedures, promoting its use. The reasons include research, training, efficacy, evidence based practices, stress reduction and better performance of the mental health professionals. Based on Dialectical Behavioral Therapy, this protocol has been designed and used in a program with severly disturb clients. This article also discusses the advantages and disadvantages of the No Harm Contracts versus its replacement for Treatment Agreements or Compromises. PMID:20440411

  20. Towards a clinically relevant lentiviral transduction protocol for primary human CD34 hematopoietic stem/progenitor cells.

    Directory of Open Access Journals (Sweden)

    Michelle Millington

    Full Text Available BACKGROUND: Hematopoietic stem cells (HSC, in particular mobilized peripheral blood stem cells, represent an attractive target for cell and gene therapy. Efficient gene delivery into these target cells without compromising self-renewal and multi-potency is crucial for the success of gene therapy. We investigated factors involved in the ex vivo transduction of CD34(+ HSCs in order to develop a clinically relevant transduction protocol for gene delivery. Specifically sought was a protocol that allows for efficient transduction with minimal ex vivo manipulation without serum or other reagents of animal origin. METHODOLOGY/PRINCIPAL FINDINGS: Using commercially available G-CSF mobilized peripheral blood (PB CD34(+ cells as the most clinically relevant target, we systematically examined factors including the use of serum, cytokine combinations, pre-stimulation time, multiplicity of infection (MOI, transduction duration and the use of spinoculation and/or retronectin. A self-inactivating lentiviral vector (SIN-LV carrying enhanced green fluorescent protein (GFP was used as the gene delivery vehicle. HSCs were monitored for transduction efficiency, surface marker expression and cellular function. We were able to demonstrate that efficient gene transduction can be achieved with minimal ex vivo manipulation while maintaining the cellular function of transduced HSCs without serum or other reagents of animal origin. CONCLUSIONS/SIGNIFICANCE: This study helps to better define factors relevant towards developing a standard clinical protocol for the delivery of SIN-LV into CD34(+ cells.

  1. Designing Ontology-based Patterns for the Representation of the Time-Relevant Eligibility Criteria of Clinical Protocols.

    Science.gov (United States)

    Crowe, Christopher L; Tao, Cui

    2015-01-01

    The amount of time and money required to screen patients for clinical trial and guideline eligibility presents the need for an automated screening process to streamline clinical trial enrollment and guideline implementation. This paper introduces an ontology-based approach for defining a set of patterns that can be used to represent various types of time-relevant eligibility criteria that may appear in clinical protocols. With a focus only on temporal requirements, we examined the criteria of 600 protocols and extracted a set of 37 representative time-relevant eligibility criteria. 16 patterns were designed to represent these criteria. Using a test set of an additional 100 protocols, it was found that these 16 patterns could sufficiently represent 98.5% of the time-relevant criteria. After the time-relevant criteria are modeled by these patterns, it will allow the potential to (1) use natural language processing algorithms to automatically extract temporal constraints from criteria; and (2) develop computer rules and queries to automate the processing of the criteria. PMID:26306263

  2. Updating the AAPM's TG-51 protocol for clinical reference dosimetry of high-energy photon beams

    International Nuclear Information System (INIS)

    -class ionization chamber is proposed, which will minimize the error in using a dosimetry protocol with calculated beam-quality conversion factors. This specification eliminates the majority of micro-ionization chambers and a number of other chambers (mainly due to anomalous polarity and recombination characteristics). All 0.6 cm3 Farmer-type chambers and their derivatives are included in the recommended list. Polarizing voltage - two requirements are necessary for correct measurement of the ion recombination correction: i) users characterize any chamber adequately, and (ii) users select the correct polarizing voltage. This Working Group recommends an upper limit of 300 V for thimble chambers used for reference dosimetry. Uncertainty - an analysis showed that the overall uncertainty in the reference dose determination depends on the assumptions made in the clinic and the procedure followed by the physicist. The standard uncertainty in the measurements of absorbed dose to water could range between 0.9 % and 2.4 %, a significant variation. It is expected that the addendum to TG-51 for photon beams will be published in 2011

  3. Remotely-Supervised Transcranial Direct Current Stimulation (tDCS for Clinical Trials: Guidelines for Technology and Protocols

    Directory of Open Access Journals (Sweden)

    Leigh E Charvet

    2015-03-01

    Full Text Available The effect of transcranial direct current stimulation (tDCS is cumulative. Treatment protocols typically require multiple consecutive sessions spanning weeks or months. However, traveling to clinic for a tDCS session can present an obstacle to subjects and their caregivers. With modified devices and headgear, tDCS treatment can be administered remotely under clinical supervision, potentially enhancing recruitment, throughput, and convenience. Here we propose standards and protocols for clinical trials utilizing remotely-supervised tDCS with the goal of providing safe, reproducible and well-tolerated stimulation therapy outside of the clinic. The recommendations include: 1 training of staff in tDCS treatment and supervision, 2 assessment of the user’s capability to participate in tDCS remotely, 3 ongoing training procedures and materials including assessments of the user and/or caregiver, 4 simple and fail-safe electrode preparation techniques and tDCS headgear, 5 strict dose control for each session, 6 ongoing monitoring to quantify compliance (device preparation, electrode saturation/placement, stimulation protocol, with corresponding corrective steps as required, 7 monitoring for treatment-emergent adverse effects, 8 guidelines for discontinuation of a session and/or study participation including emergency failsafe procedures tailored to the treatment population’s level of need. These guidelines are intended to provide a minimal level of methodological rigor for clinical trials seeking to apply tDCS outside a specialized treatment center. We outline indication-specific applications (Attention Deficit Hyperactivity Disorder, Depression, Multiple Sclerosis, Palliative Care following these recommendations that support a standardized framework for evaluating the tolerability and reproducibility of remote-supervised tDCS that, once established, will allow for translation of tDCS clinical trials to a greater size and range of patient populations.

  4. Implementation and evaluation of the SPRINT protocol for tight glycaemic control in critically ill patients: a clinical practice change

    OpenAIRE

    Chase, J Geoffrey; Shaw, Geoffrey; Le Compte, Aaron; Lonergan, Timothy; Willacy, Michael; Wong, Xing-Wei; Lin, Jessica; Lotz, Thomas; Lee, Dominic; Hann, Christopher

    2008-01-01

    Introduction Stress-induced hyperglycaemia is prevalent in critical care. Control of blood glucose levels to within a 4.4 to 6.1 mmol/L range or below 7.75 mmol/L can reduce mortality and improve clinical outcomes. The Specialised Relative Insulin Nutrition Tables (SPRINT) protocol is a simple wheel-based system that modulates insulin and nutritional inputs for tight glycaemic control. Methods SPRINT was implemented as a clinical practice change in a general intensive care unit (ICU). The obj...

  5. Economic comparison of common treatment protocols and J5 vaccination for clinical mastitis in dairy herds using optimized culling decisions.

    Science.gov (United States)

    Kessels, J A; Cha, E; Johnson, S K; Welcome, F L; Kristensen, A R; Gröhn, Y T

    2016-05-01

    This study used an existing dynamic optimization model to compare costs of common treatment protocols and J5 vaccination for clinical mastitis in US dairy herds. Clinical mastitis is an infection of the mammary gland causing major economic losses in dairy herds due to reduced milk production, reduced conception, and increased risk of mortality and culling for infected cows. Treatment protocols were developed to reflect common practices in dairy herds. These included targeted therapy following pathogen identification, and therapy without pathogen identification using a broad-spectrum antimicrobial or treating with the cheapest treatment option. The cost-benefit of J5 vaccination was also estimated. Effects of treatment were accounted for as changes in treatment costs, milk loss due to mastitis, milk discarded due to treatment, and mortality. Following ineffective treatments, secondary decisions included extending the current treatment, alternative treatment, discontinuing treatment, and pathogen identification followed by recommended treatment. Average net returns for treatment protocols and vaccination were generated using an existing dynamic programming model. This model incorporates cow and pathogen characteristics to optimize management decisions to treat, inseminate, or cull cows. Of the treatment protocols where 100% of cows received recommended treatment, pathogen-specific identification followed by recommended therapy yielded the highest average net returns per cow per year. Out of all treatment scenarios, the highest net returns were achieved with selecting the cheapest treatment option and discontinuing treatment, or alternate treatment with a similar spectrum therapy; however, this may not account for the full consequences of giving nonrecommended therapies to cows with clinical mastitis. Vaccination increased average net returns in all scenarios. PMID:26947301

  6. Uncertainties on measurements of absorbed-dose-to-water, from clinical high-energy eletron beams: a comparison with the IAEA protocols

    International Nuclear Information System (INIS)

    A pilot study was performed to verify the troubles involved in the implementation of dosimetric protocol TRS 398 for absorbed-dose-to-water, using clinical high-energy electron beams and to accomplish an detailed evaluation of uncertainty chain components associated to the measurement, which ones were not treated in the IAEA protocols, aimed the standardization of technical procedures. (author)

  7. Uncertainties on measurements of absorbed-dose-to-water, from clinical high- energy electron beams: a comparison with the IAEA protocols

    International Nuclear Information System (INIS)

    A pilot study was performed to verify the troubles involved in the implementation of dosimetric protocol TRS 398 for absorbed-dose-to-water, using clinical high-energy electron beams and to accomplish an detailed evaluation of uncertainty chain components associated to the measurement, which ones were not treated in the IAEA protocols, aimed the standardization of technical procedures. (author)

  8. Glenoid version by CT scan: an analysis of clinical measurement error and introduction of a protocol to reduce variability

    Energy Technology Data Exchange (ETDEWEB)

    Bunt, Fabian van de [VU University Medical Center, Amsterdam (Netherlands); Pearl, Michael L.; Lee, Eric K.; Peng, Lauren; Didomenico, Paul [Kaiser Permanente, Los Angeles, CA (United States)

    2015-11-15

    Recent studies have challenged the accuracy of conventional measurements of glenoid version. Variability in the orientation of the scapula from individual anatomical differences and patient positioning, combined with differences in observer measurement practices, have been identified as sources of variability. The purpose of this study was to explore the utility and reliability of clinically available software that allows manipulation of three-dimensional images in order to bridge the variance between clinical and anatomic version in a clinical setting. Twenty CT scans of normal glenoids of patients who had proximal humerus fractures were measured for version. Four reviewers first measured version in a conventional manner (clinical version), measurements were made again (anatomic version) after employing a protocol for reformatting the CT data to align the coronal and sagittal planes with the superior-inferior axis of the glenoid, and the scapular body, respectively. The average value of clinical retroversion for all reviewers and all subjects was -1.4 (range, -16 to 21 ), as compared to -3.2 (range, -21 to 6 ) when measured from reformatted images. The mean difference between anatomical and clinical version was 1.9 ± 5.6 but ranged on individual measurements from -13 to 26 . In no instance did all four observers choose the same image slice from the sequence of images. This study confirmed the variation in glenoid version dependent on scapular orientation previously identified in other studies using scapular models, and presents a clinically accessible protocol to correct for scapular orientation from the patient's CT data. (orig.)

  9. Glenoid version by CT scan: an analysis of clinical measurement error and introduction of a protocol to reduce variability

    International Nuclear Information System (INIS)

    Recent studies have challenged the accuracy of conventional measurements of glenoid version. Variability in the orientation of the scapula from individual anatomical differences and patient positioning, combined with differences in observer measurement practices, have been identified as sources of variability. The purpose of this study was to explore the utility and reliability of clinically available software that allows manipulation of three-dimensional images in order to bridge the variance between clinical and anatomic version in a clinical setting. Twenty CT scans of normal glenoids of patients who had proximal humerus fractures were measured for version. Four reviewers first measured version in a conventional manner (clinical version), measurements were made again (anatomic version) after employing a protocol for reformatting the CT data to align the coronal and sagittal planes with the superior-inferior axis of the glenoid, and the scapular body, respectively. The average value of clinical retroversion for all reviewers and all subjects was -1.4 (range, -16 to 21 ), as compared to -3.2 (range, -21 to 6 ) when measured from reformatted images. The mean difference between anatomical and clinical version was 1.9 ± 5.6 but ranged on individual measurements from -13 to 26 . In no instance did all four observers choose the same image slice from the sequence of images. This study confirmed the variation in glenoid version dependent on scapular orientation previously identified in other studies using scapular models, and presents a clinically accessible protocol to correct for scapular orientation from the patient's CT data. (orig.)

  10. Digital protocol for reference-based guided surgery and immediate loading: a prospective clinical study

    NARCIS (Netherlands)

    A. Tahmaseb; R. de Clerck; I. Aartman; D. Wismeijer

    2012-01-01

    PURPOSE: To evaluate the performance of a computer-aided three-dimensional planning protocol in combination with previously inserted reference mini-implants and CAD/CAM technology to restore completely edentulous patients. The study evaluated implant and superstructure survival in a prospective clin

  11. Protocol for Bone Augmentation with Simultaneous Early Implant Placement: A Retrospective Multicenter Clinical Study

    Directory of Open Access Journals (Sweden)

    Peter Fairbairn

    2015-01-01

    Full Text Available Purpose. To present a novel protocol for alveolar bone regeneration in parallel to early implant placement. Methods. 497 patients in need of extraction and early implant placement with simultaneous bone augmentation were treated in a period of 10 years. In all patients the same specific method was followed and grafting was performed utilizing in situ hardening fully resorbable alloplastic grafting materials consisting of β-tricalcium phosphate and calcium sulfate. The protocol involved atraumatic extraction, implant placement after 4 weeks with simultaneous bone augmentation, and loading of the implant 12 weeks after placement and grafting. Follow-up periods ranged from 6 months to 10 years (mean of 4 years. Results. A total of 601 postextraction sites were rehabilitated in 497 patients utilizing the novel protocol. Three implants failed before loading and three implants failed one year after loading, leaving an overall survival rate of 99.0%. Conclusions. This standardized protocol allows successful long-term functional results regarding alveolar bone regeneration and implant rehabilitation. The concept of placing the implant 4 weeks after extraction, augmenting the bone around the implant utilizing fully resorbable, biomechanically stable, alloplastic materials, and loading the implant at 12 weeks seems to offer advantages when compared with traditional treatment modalities.

  12. A protocol for classifying normal- and flat-arched foot posture for research studies using clinical and radiographic measurements

    Directory of Open Access Journals (Sweden)

    Menz Hylton B

    2009-07-01

    Full Text Available Abstract Background There are several clinical and radiological methods available to classify foot posture in research, however there is no clear strategy for selecting the most appropriate measurements. Therefore, the aim of this study was to develop a foot screening protocol to distinguish between participants with normal- and flat-arched feet who would then subsequently be recruited into a series of laboratory-based gait studies. Methods The foot posture of ninety-one asymptomatic young adults was assessed using two clinical measurements (normalised navicular height and arch index and four radiological measurements taken from antero-posterior and lateral x-rays (talus-second metatarsal angle, talo-navicular coverage angle, calcaneal inclination angle and calcaneal-first metatarsal angle. Normative foot posture values were taken from the literature and used to recruit participants with normal-arched feet. Data from these participants were subsequently used to define the boundary between normal- and flat-arched feet. This information was then used to recruit participants with flat-arched feet. The relationship between the clinical and radiographic measures of foot posture was also explored. Results Thirty-two participants were recruited to the normal-arched study, 31 qualified for the flat-arched study and 28 participants were classified as having neither normal- or flat-arched feet and were not suitable for either study. The values obtained from the two clinical and four radiological measurements established two clearly defined foot posture groups. Correlations among clinical and radiological measures were significant (p r = 0.24 to 0.70. Interestingly, the clinical measures were more strongly associated with the radiographic angles obtained from the lateral view. Conclusion This foot screening protocol provides a coherent strategy for researchers planning to recruit participants with normal- and flat-arched feet. However, further research is

  13. Randomized clinical trial comparing ceftiofur hydrochloride with a positive control protocol for intramammary treatment of nonsevere clinical mastitis in dairy cows.

    Science.gov (United States)

    Cortinhas, Cristina Simões; Tomazi, Tiago; Zoni, Mário Sérgio Ferreira; Moro, Elio; Veiga Dos Santos, Marcos

    2016-07-01

    The objective of this study was to compare ceftiofur hydrochloride with a positive control protocol for intramammary treatment of nonsevere clinical mastitis in dairy cows. A total of 264 clinical mastitis cases on 11 commercial dairy farms were treated with intramammary infusions, once a day for 4 d using 1 of 2 treatments: (1) ceftiofur hydrochloride 125mg; or (2) control: tetracycline 200mg + neomycin 250mg + bacitracin 28mg + prednisolone 10mg. Streptococcus agalactiae was the most frequently isolated gram-positive pathogen from clinical mastitis, followed by Staphylococcus aureus. Klebsiella spp. and Escherichia coli were the most isolated gram-negative bacteria from clinical mastitis. No significant differences were observed between treatments regarding the overall clinical cure, bacteriological cure, and new infection. No effect of treatment regimen was observed when the bacterial group (gram-positive vs. gram-negative) was evaluated. The overall clinical cure was 0.79 for ceftiofur-treated cows and 0.74 for control-treated cows, whereas the overall bacteriological cure was 0.79 for ceftiofur-treated cows and 0.76 for control-treated cows. Furthermore, the new intramammary infection was 0.10 for cows treated with ceftiofur and 0.11 for cows treated with control. In conclusion, the use of intramammary ceftiofur hydrochloride for treatment of nonsevere clinical mastitis has similar efficacy as a treatment regimen with a combination of antimicrobial agents (tetracycline + neomycin + bacitracin). PMID:27157576

  14. Development of software for clinical protocols in nuclear medicine. Final report for the period 21 November 1994 - 21 November 1995

    International Nuclear Information System (INIS)

    After two technical contracts of IAEA, a portable image processing software (PIP) has been developed and some clinical protocols for nuclear medicine studies with IBM PCs which are connected to analogue gamma cameras. In addition, a suitable front end for driving some PC/gamma camera interface cards have been successfully tested and extended. The on-line help facilities and the user interface within PIP was remarkably improved, for medical physicists as developers as well as for technologists as users for routine studies

  15. Computer simulations to estimate organ doses from clinically validated cardiac, neuro, and pediatric protocols for multiple detector computed tomography scanners

    Science.gov (United States)

    Ghita, Monica

    Recent advances in Computed Tomography (CT) technology, particularly that of multiple detector CT (MDCT) scanning, have provided increased utilization and more diverse clinical applications including more advanced vascular and cardiac exams, perfusion imaging, and screening exams. Notwithstanding the benefits to the patient undergoing a CT study, the fundamental concern in radiation protection is the minimization of the radiation exposure delivered as well as the implementation of structures to prevent inappropriate ordering and clinical use of these advanced studies. This research work developed a computational methodology for routine clinical use to assess patient organ doses from MDCT scanners. To support the methodology, a computer code (DXS-Diagnostic X-ray Spectra) was developed to accurately and conveniently generate x-ray spectra in the diagnostic energy range (45-140 keV). The two accepted standard radiation transport calculation methods namely, deterministic and Monte Carlo, have been preliminarily investigated for their capability and readiness to support the proposed goal of the work. Thorough tests demonstrated that the lack of appropriate discrete photon interaction coefficients in the aforementioned diagnostic energy range impedes the applicability of the deterministic approach to routine clinical use; improvements in the multigroup treatment may make it more viable. Thus, the open source Monte Carlo code, MCNP5, was adapted to appropriately model an MDCT scan. For this, a new method, entirely based on routine clinical CT measurements, was developed and validated to generate an "equivalent source and filtration" model that obviates the need of proprietary information for a given CT scanner. Computer simulations employing the Monte Carlo methodology and UF's tomographic human phantoms were performed to assess, compare, and optimize pediatric, cardiac and neuro-imaging protocols for the new 320-slice scanner at Shands/UF based on dose considerations

  16. Clinical Experience With Image-Guided Radiotherapy in an Accelerated Partial Breast Intensity-Modulated Radiotherapy Protocol

    International Nuclear Information System (INIS)

    Purpose: To explore the feasibility of fiducial markers for the use of image-guided radiotherapy (IGRT) in an accelerated partial breast intensity modulated radiotherapy protocol. Methods and Materials: Nineteen patients consented to an institutional review board approved protocol of accelerated partial breast intensity-modulated radiotherapy with fiducial marker placement and treatment with IGRT. Patients (1 patient with bilateral breast cancer; 20 total breasts) underwent ultrasound guided implantation of three 1.2- x 3-mm gold markers placed around the surgical cavity. For each patient, table shifts (inferior/superior, right/left lateral, and anterior/posterior) and minimum, maximum, mean error with standard deviation were recorded for each of the 10 BID treatments. The dose contribution of daily orthogonal films was also examined. Results: All IGRT patients underwent successful marker placement. In all, 200 IGRT treatment sessions were performed. The average vector displacement was 4 mm (range, 2-7 mm). The average superior/inferior shift was 2 mm (range, 0-5 mm), the average lateral shift was 2 mm (range, 1-4 mm), and the average anterior/posterior shift was 3 mm (range, 1 5 mm). Conclusions: This study shows that the use of IGRT can be successfully used in an accelerated partial breast intensity-modulated radiotherapy protocol. The authors believe that this technique has increased daily treatment accuracy and permitted reduction in the margin added to the clinical target volume to form the planning target volume.

  17. Educating for health service reform: clinical learning, governance and capability – a case study protocol

    OpenAIRE

    Gardner, Anne; Gardner, Glenn; Coyer, Fiona; Gosby, Helen

    2016-01-01

    Background The nurse practitioner is a growing clinical role in Australia and internationally, with an expanded scope of practice including prescribing, referring and diagnosing. However, key gaps exist in nurse practitioner education regarding governance of specialty clinical learning and teaching. Specifically, there is no internationally accepted framework against which to measure the quality of clinical learning and teaching for advanced specialty practice. Methods A case study design wil...

  18. Co-Designing Mobile Apps to Assist in Clinical Nursing Education: A Study Protocol.

    Science.gov (United States)

    O'Connor, Siobhan; Andrews, Tom

    2016-01-01

    Mobile applications (apps) to train health professionals is gaining momentum as the benefits of mobile learning (mLearning) are becoming apparent in complex clinical environments. However, most educational apps are generic, off-the-shelf pieces of software that do not take into consideration the unique needs of nursing students. The proposed study will apply a user-centred design process to create a tailored mobile app for nursing students to learn and apply clinical skills in practice. The app will be piloted and evaluated to understand how nursing students use mobile technology in clinical settings to support their learning and educational needs. PMID:27332433

  19. Identifying low-value clinical practices in critical care medicine: protocol for a scoping review

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    Niven, Daniel J; McCormick, T Jared; Straus, Sharon E; Hemmelgarn, Brenda R.; Jeffs, Lianne P.; Stelfox, Henry T

    2015-01-01

    Introduction Reducing unnecessary, low-value clinical practice (ie, de-adoption) is key to improving value for money in healthcare, especially among patients admitted to intensive care units (ICUs) where resource consumption exceeds other medical and surgical populations. Research suggests that low-value clinical practices are common in medicine, however systematically and objectively identifying them is a widely cited barrier to de-adoption. We will conduct a scoping review to identify low-v...

  20. Clinical protocols for 31P MRS of the brain and their use in evaluating optic pathway gliomas in children

    International Nuclear Information System (INIS)

    Introduction: In vivo 31P Magnetic Resonance Spectroscopy (MRS) measures phosphorus-containing metabolites that play an essential role in many disease processes. An advantage over 1H MRS is that total choline can be separated into phosphocholine and glycerophosphocholine which have opposite associations with tumour grade. We demonstrate 31P MRS can provide robust metabolic information on an acceptable timescale to yield information of clinical importance. Methods: All MRI examinations were carried out on a 3T whole body scanner with all 31P MRS scans conducted using a dual-tuned 1H/31P head coil. Once optimised on phantoms, the protocol was tested in six healthy volunteers (four male and two female, mean age: 25 ± 2.7). 31P MRS was then implemented on three children with optic pathway gliomas. Results: 31P MRS on volunteers showed that a number of metabolite ratios varied significantly (p < 0.05 ANOVA) across different structures of the brain, whereas PC/GPC did not. Standard imaging showed the optic pathway gliomas were enhancing on T1-weighted imaging after contrast injection and have high tCho on 1H MRS, both of which are associated with high grade lesions. 31P MRS showed the phosphocholine/glycerophosphocholine ratio to be low (<0.6) which suggests low grade tumours in keeping with their clinical behaviour and the histology of most biopsied optic pathway gliomas. Conclusion: 31P MRS can be implemented in the brain as part of a clinical protocol to provide robust measurement of important metabolites, in particular providing a greater understanding of cases where tCho is raised on 1H MRS

  1. An Imaging Diagnostic Protocol in Children with Clinically Suspected Acute Appendicitis.

    Science.gov (United States)

    Epifanio, Matias; Antonio de Medeiros Lima, Marco; Corrêa, Patricia; Baldisserotto, Matteo

    2016-05-01

    The objective of the present study is to evaluate a new diagnostic strategy using clinical findings followed by ultrasound (US) and, in selected cases, MRI. This study included 166 children presenting signs and symptoms suggesting acute appendicitis. Cases classified as suggesting appendicitis according to clinical exams had to be referred to surgery, whereas the other cases were discharged. Unclear cases were evaluated using US. If the US results were considered inconclusive, patients underwent MRI. Of the 166 patients, 78 (47%) had acute appendicitis and 88 (53%) had other diseases. The strategy under study had a sensitivity of 96 per cent, specificity of 100 per cent, positive predictive value of 100 per cent, negative predictive value of 97 per cent, and accuracy of 98 per cent. Eight patients remained undiagnosed and underwent MRI. After MRI two girls presented normal appendixes and were discharged. One girl had an enlarged appendix on MRI and appendicitis could have been confirmed by surgery. In the other five patients, no other sign of the disease was detected by MRI such as an inflammatory mass, free fluid or an abscess in the right iliac fossa. All of them were discharged after clinical observation. In the vast majority of cases the correct diagnosis was reached by clinical and US examinations. When clinical assessment and US findings were inconclusive, MRI was useful to detect normal and abnormal appendixes and valuable to rule out other abdominal pathologies that mimic appendicitis. PMID:27215717

  2. Brief strategic therapy for obsessive–compulsive disorder: a clinical and research protocol of a one-group observational study

    Science.gov (United States)

    Pietrabissa, Giada; Manzoni, Gian Mauro; Gibson, Padraic; Boardman, Donald; Gori, Alessio; Castelnuovo, Gianluca

    2016-01-01

    Introduction Obsessive–compulsive disorder (OCD) is a disabling psychopathology. The mainstay of treatment includes cognitive–behavioural therapy (CBT) and medication management. However, individual suffering, functional impairments as well as the direct and indirect costs associated with the disease remain substantial. New treatment programmes are necessary and the brief strategic therapy (BST) has recently shown encouraging results in clinical practice but no quantitative study has as yet been conducted. Methods and analysis The clinical effectiveness of the OCD-specific BST protocol will be evaluated in a one-group observational study. Participants will be sequentially recruited from a state community psychotherapy clinic in Dublin, Ireland. Outcome measures will be the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the Beck Depression Inventory-II (BDI-II). Data will be collected at baseline, at treatment termination and at 3 month follow-up. The statistical significance of the post-treatment effect will be assessed by the paired-sample Student t test, while clinical significance will be evaluated by means of the equivalence testing method, which will be also used to assess the maintenance of effect at follow-up. Ethics/dissemination The present study is approved by the Hesed House Ethics Board in Dublin. Findings will enhance the evidence-based knowledge about the clinical effectiveness of BST in treating OCD symptoms, prior to assessing its efficacy in a randomised and controlled clinical trial, and will be disseminated through publication in peer-reviewed journals and conference presentations. PMID:27013594

  3. Yoga for Health Care in Korea: A Protocol for Systematic Review of Clinical Trials.

    Science.gov (United States)

    Choi, Jiae; Jun, Ji Hee; Lee, Ju Ah; Lee, Myeong Soo

    2016-08-01

    This systematic review aims to evaluate the therapeutic effects of yoga therapy using an evidence-based approach and investigates the relationship between yoga and the meridian energies based on all available clinical studies in Korea. Sixteen electronic databases will be searched from the inception of the study until January 2016. All clinical evidences that evaluate any type of yoga and any type of control in individuals with any type of condition will be eligible. The methodological quality will be assessed using the Cochrane risk of bias tool for randomized clinical trials and the Newcastle-Ottawa scale for nonrandomized studies. Two authors will independently assess each study for eligibility and the risk of bias, and then they will extract the data. With its extensive, unbiased search of the Korean literature from various databases without any language restrictions, this systematic review will be useful for both practitioners in the field of yoga research as well as for patients. PMID:27555227

  4. Pilot study of the IAEA protocol for clinical commissioning of treatment planning systems

    International Nuclear Information System (INIS)

    Clinical test cases to facilitate the commissioning process of radiotherapy treatment planning system (TPS) were developed by participants of the IAEA coordinated research project (CRP) on 'Development of procedures for quality assurance for dosimetry calculation in radiotherapy'. The tests cover basic treatment techniques in typical radiotherapy installations and are based on the use of CIRS torso phantom. The practicability of the commissioning tests is assured through their trial use in the clinical facilities of different sizes. All hospitals used the same type of phantom which was scanned twice with computer tomography (CT). At the first scan different inserts were introduced into the phantom to derive the CT number to relative electron density conversion curve. At the second scan the phantom CT slices were acquired for planning of different clinical test cases on TPS. The dose was measured with ionization chamber placed inside the phantom. In this work we present the results from eleven hospitals which are using fifteen different TPSs. Altogether there are 37 different combinations of algorithms and beam qualities. The use of the phantom and the tests proposed in the CRP enabled the evaluation of accuracy and limitations of different algorithms as well as inconsistencies in the loaded data. The differences between TPS dose calculations and measurements for different photon beam algorithms and inhomogeneity correction methods which exceed 3% tolerance limit are shown. More results for different clinical test cases as well as test descriptions will be presented at the conference. Results of the pilot study have shown that proposed test cases can not only serve to ensure the safe use of the TPS in a specific clinic, but may also help the user to appreciate the possibilities of their system and understand its limitations. The set of tests for clinical commissioning can be performed in reasonable time in the majority of hospitals, particularly in those with

  5. Effect of back school protocol on the referral rate of patients with low back pain to an industrial physiotherapy clinic

    Directory of Open Access Journals (Sweden)

    D. O. Odebiyi

    2006-02-01

    Full Text Available Back schools are educational programmes originally developed in a work place (Volvo factory in Sweden for patients with back pain, to enable them to manage their own back problems better. ‘Back school’ was originally aimed at modifying the behaviours of patients with low back pain (LBP, with the view to prevent relapses. In an effort to encourage and stimulate the use of ‘back school’ among health workers in Nigeria, this study was designed to evaluate the efficacy of a back school protocol in a Soap Making Industry in Lagos, Nigeria. One hundred and ten (110 workers of a Soap Making Industry in Lagos, Nigeria,  participated in this study. A pre-test, post-test experimental design was employed. The participants were divided into two groups - office workers and factory workers for the purpose of the training in the content of the back school protocol. The ‘back school’ consisted of classroom teaching and the use of two videotapes titled “lifting technique” and “back pain”. Data on demographic information, knowledge of back structures and back care were collected using a questionnaire with closed ended questions, which was completed before, immediately after and 8 weeks after the administrations of the contents of the back school protocol (Akinpelu and Odebiyi, 2004. The records of the factory’s clinic were also reviewed for the 12-months before and 12 months after the study. The mean values of the participants’ age, height, weight and body mass index (BMI were 36.60 ± 9.10 years, 1.65 ± 0.10 m,69.13 ± 7.70 kg and 25.40 ± 3.30 kg/m2 respectively. The results showed that the 12-months prevalence of low back pain (LBP among the workers was 71%. The result also showed that over 50% of the participants never had any  information or lesson on back care, and those that had some form of information obtained it by chance. There was 23% reduction in referral for care of back pain 12 months after the administration of the back

  6. Participation of nurses in the execution of clinical research protocol about technological innovation

    Directory of Open Access Journals (Sweden)

    Luciane Patrícia Andreani Cabral

    2015-10-01

    Full Text Available AbstractOBJECTIVETo report the nurse's experience of inclusion in interdisciplinary clinical study about technological innovation, involving people with spinal cord injury.METHODDescriptive experience report. The empirical support was based on notes about perspectives and practice of clinical research, with a multi-professional nursing, physical education, physiotherapy and engineering staff.RESULTThe qualification includes the elaboration of the document for the Ethics Committee, familiarization among the members of staff and with the studied topic, and also an immersion into English. The nurse's knowledge gave support to the uptake of participants and time adequacy for data collection, preparation and assistance of the participants during the intervention and after collection. Nursing theories and processes have contributed to reveal risky diagnoses and the plan of care. It was the nurse's role to monitor the risk of overlapping methodological strictness to the human aspect. The skills for the clinical research must be the object of learning, including students in multidisciplinary researches.CONCLUSIONTo qualify the nurse for clinical research and to potentialize its caregiver essence, some changes are needed in the educational system, professional behavior, attitude and educational assistance.

  7. A xenogeneic-free protocol for isolation and expansion of human adipose stem cells for clinical uses.

    Directory of Open Access Journals (Sweden)

    Carmen Escobedo-Lucea

    Full Text Available Human adipose stem cells (HASCS play a crucial role in the fields of regenerative medicine and tissue engineering for different reasons: the abundance of adipose tissue, their easy harvesting, the ability to multipotent differentiation and the fact that they do not trigger allogeneic blood response or secrete cytokines that act as immunosuppressants. The vast majority of protocols use animal origin reagents, with the underlying risk of transmitting infections by non-human pathogens. We have designed a protocol to isolate and maintain the properties of hASCs avoiding xenogeneic reagents. These changes not only preserve hASCs morphology, but also increase cell proliferation and maintain their stem cell marker profile. On the other hand, human serum albumin (HSA, Tryple® and human Serum (HS, do not affect hASCs multipotent differentiation ability. The amendments introduced do not trigger modifications in the transcriptional profile of hASCs, alterations in key biochemical pathways or malignization. Thus, we have proven that it is possible to isolate and maintain hASCs avoiding animal reagents and, at the same time, preserving crucial culture parameters during long term culture. Thereby we have revealed a novel and effective tool for the improvement of clinical, cell-based therapies.

  8. SCISSOR—Spinal Cord Injury Study on Small molecule-derived Rho inhibition: a clinical study protocol

    Science.gov (United States)

    Kopp, Marcel A; Liebscher, Thomas; Watzlawick, Ralf; Martus, Peter; Laufer, Stefan; Blex, Christian; Schindler, Ralf; Jungehulsing, Gerhard J; Knüppel, Sven; Kreutzträger, Martin; Ekkernkamp, Axel; Dirnagl, Ulrich; Strittmatter, Stephen M; Niedeggen, Andreas; Schwab, Jan M

    2016-01-01

    Introduction The approved analgesic and anti-inflammatory drugs ibuprofen and indometacin block the small GTPase RhoA, a key enzyme that impedes axonal sprouting after axonal damage. Inhibition of the Rho pathway in a central nervous system-effective manner requires higher dosages compared with orthodox cyclooxygenase-blocking effects. Preclinical studies on spinal cord injury (SCI) imply improved motor recovery after ibuprofen/indometacin-mediated Rho inhibition. This has been reassessed by a meta-analysis of the underlying experimental evidence, which indicates an overall effect size of 20.2% regarding motor outcome achieved after ibuprofen/indometacin treatment compared with vehicle controls. In addition, ibuprofen/indometacin may also limit sickness behaviour, non-neurogenic systemic inflammatory response syndrome (SIRS), neuropathic pain and heterotopic ossifications after SCI. Consequently, ‘small molecule’-mediated Rho inhibition after acute SCI warrants clinical investigation. Methods and analysis Protocol of an investigator-initiated clinical open-label pilot trial on high-dose ibuprofen treatment after acute traumatic, motor-complete SCI. A sample of n=12 patients will be enrolled in two cohorts treated with 2400 mg/day ibuprofen for 4 or 12 weeks, respectively. The primary safety end point is an occurrence of serious adverse events, primarily gastroduodenal bleedings. Secondary end points are pharmacokinetics, feasibility and preliminary effects on neurological recovery, neuropathic pain and heterotopic ossifications. The primary safety analysis is based on the incidence of severe gastrointestinal bleedings. Additional analyses will be mainly descriptive and casuistic. Ethics and dissemination The clinical trial protocol was approved by the responsible German state Ethics Board, and the Federal Institute for Drugs and Medical Devices. The study complies with the Declaration of Helsinki, the principles of Good Clinical Practice and all further

  9. [Introduction of a clinical protocol for extravasation at the National Institute of Oncology, Budapest, Hungary].

    Science.gov (United States)

    Bartal, Alexandra; Mátrai, Zoltán; Rosta, András; Szûcs, Attila

    2011-03-01

    Extravasation of cytostatics occurs when an infusion containing a cytotoxic drug leaks into the surrounding perivascular and subcutaneous tissues. Incidence of cytostatic extravasation is found to be 0.1-6% according to the literature. Depending on the severity of complications, pain, loss of function in the extremities, or in extreme cases tissue necrosis necessitating an amputation may develop, drawing consequences like delay or interruption of the chemotherapy. Extent of complications is greatly influenced by the type of medication administered, general condition of the patient, and professional preparedness of staff providing the oncological health service. The protocol recently implemented in the National Institute of Oncology is a short, compact guidance for physicians and nurses providing oncological care, so by quick and adequate management of extravasation cases, severe complications could be prevented. More complex practical guidelines including algorithms could be created as a result of a wider collaboration, with the help of which oncological health professionals could easily cope with this rare problem. The authors describe in their review the implementation of the use of dry warm and cold packs, dymethylsulfoxide and hyaluronidase and their function within the algorithm of extravasation treatment. PMID:21617787

  10. Intra-Arterial Magnetic Resonance Angiography of the Iliac Arteries: Clinical Experience Using Two Different Protocols

    Energy Technology Data Exchange (ETDEWEB)

    Paetzel, C.; Zorger, N.; Voelk, M.; Herold, T.; Seitz, J.; Nitz, W. R.; Feuerbach, S.; Hamer, O.; Lenhart, M. [Univ. Hospital of Regensburg (Germany). Dept. of Diagnostic Radiology

    2005-05-01

    Purpose: To assess the feasibility of intra-arterial magnetic resonance angiography (iaMRA) with two different protocols. Material and Methods: Twenty patients were prospectively examined after digital subtraction angiography. Contrast-enhanced iaMRA was performed using a.5 T magnetic resonance imaging (MRI) system. Contrast agent (gadodiamide) was injected through a conventional angiography catheter placed in the abdominal aorta. The patients were randomized into two groups each comprising 10 patients. Group 1 was examined with a FLASH-3D (fast low-angle shot) sequence, allowing the center of the k-space to be acquired 0.5 s after initiation of the measurement. Group 2 was examined with the identical sequence, but the center of the k-space was acquired after 8.7 s. The increase in the intravascular signal intensity was determined and the diagnostic value of the angiograms was independently scored by 4 investigators using a 5-point scale. Results: Nineteen of 20 MRAs were scored as diagnostic; only 1 was scored as non-diagnostic by 2 observers. The diagnostic value of the angiograms of group 2 was judged superior to that of group owing to a more homogeneous intravascular contrast distribution. Conclusion: Intra-arterial MRA is feasible. The diagnostic value of angiograms using a flash sequence with center of the k-space acquisition after 8.7 s ranged from good to excellent. This sequence is appropriate for iaMRA of iliac arteries to support MR guided intervention.

  11. Intra-Arterial Magnetic Resonance Angiography of the Iliac Arteries: Clinical Experience Using Two Different Protocols

    International Nuclear Information System (INIS)

    Purpose: To assess the feasibility of intra-arterial magnetic resonance angiography (iaMRA) with two different protocols. Material and Methods: Twenty patients were prospectively examined after digital subtraction angiography. Contrast-enhanced iaMRA was performed using a.5 T magnetic resonance imaging (MRI) system. Contrast agent (gadodiamide) was injected through a conventional angiography catheter placed in the abdominal aorta. The patients were randomized into two groups each comprising 10 patients. Group 1 was examined with a FLASH-3D (fast low-angle shot) sequence, allowing the center of the k-space to be acquired 0.5 s after initiation of the measurement. Group 2 was examined with the identical sequence, but the center of the k-space was acquired after 8.7 s. The increase in the intravascular signal intensity was determined and the diagnostic value of the angiograms was independently scored by 4 investigators using a 5-point scale. Results: Nineteen of 20 MRAs were scored as diagnostic; only 1 was scored as non-diagnostic by 2 observers. The diagnostic value of the angiograms of group 2 was judged superior to that of group owing to a more homogeneous intravascular contrast distribution. Conclusion: Intra-arterial MRA is feasible. The diagnostic value of angiograms using a flash sequence with center of the k-space acquisition after 8.7 s ranged from good to excellent. This sequence is appropriate for iaMRA of iliac arteries to support MR guided intervention

  12. Welfare assessment: correlations and integration between a Qualitative Behavioural Assessment and a clinical/ health protocol applied in veal calves farms

    Directory of Open Access Journals (Sweden)

    Cornelis G. Van Reenen

    2010-01-01

    Full Text Available This study is aimed at finding correlations and possible integration among Qualitative Behavioural Assessment (QBA and a specific protocol of clinical/health evaluation. Both welfare assessment methods were based on direct animal observation and were applied in 24 Italian veal calves farms at 3 weeks (wks of rearing. Principal component analysis (PCA summarized 20 QBA descriptors on two main components (PC1 and PC2 with eigenvalues above 4 and explaining 29.6 and 20.3% of the variation respectively. PCA on residuals obtained after correcting for housing condition yielded highly similar results, indicating that the rearing environment of the calves was not an important determinant of the observer reliability of QBA. A relationship was found between QBA PC2 and the presence of signs of cross-sucking recorded during the clinical visit (presence PC2=1.11 vs. absence PC2=-1.55, P<0.001. There were no other relations between the quantitative clinical measures and QBA PC’s. The frequency of farmer, veterinarian, or industry technician visits to the veal unit significantly affected QBA PC1 and PC2 scores. These results suggest that the 2 methods provide complementary types of information and can each make valid a contribution to an integrated animal welfare monitoring scheme.

  13. Optimized magnetic resonance diffusion protocol for ex-vivo whole human brain imaging with a clinical scanner

    Science.gov (United States)

    Scherrer, Benoit; Afacan, Onur; Stamm, Aymeric; Singh, Jolene; Warfield, Simon K.

    2015-03-01

    Diffusion-weighted magnetic resonance imaging (DW-MRI) provides a novel insight into the brain to facilitate our understanding of the brain connectivity and microstructure. While in-vivo DW-MRI enables imaging of living patients and longitudinal studies of brain changes, post-mortem ex-vivo DW-MRI has numerous advantages. Ex-vivo imaging benefits from greater resolution and sensitivity due to the lack of imaging time constraints; the use of tighter fitting coils; and the lack of movement artifacts. This allows characterization of normal and abnormal tissues with unprecedented resolution and sensitivity, facilitating our ability to investigate anatomical structures that are inaccessible in-vivo. This also offers the opportunity to develop today novel imaging biomarkers that will, with tomorrow's MR technology, enable improved in-vivo assessment of the risk of disease in an individual. Post-mortem studies, however, generally rely on the fixation of specimen to inhibit tissue decay which starts as soon as tissue is deprived from its blood supply. Unfortunately, fixation of tissues substantially alters tissue diffusivity profiles. In addition, ex-vivo DW-MRI requires particular care when packaging the specimen because the presence of microscopic air bubbles gives rise to geometric and intensity image distortion. In this work, we considered the specific requirements of post-mortem imaging and designed an optimized protocol for ex-vivo whole brain DW-MRI using a human clinical 3T scanner. Human clinical 3T scanners are available to a large number of researchers and, unlike most animal scanners, have a bore diameter large enough to image a whole human brain. Our optimized protocol will facilitate widespread ex-vivo investigations of large specimen.

  14. Diffusion weighted MRI of the breast: Protocol optimization, guidelines for interpretation, and potential clinical applications

    OpenAIRE

    Partridge, Savannah C.; McDonald, Elizabeth S.

    2013-01-01

    There has been increasing interest in the use of diffusion weighted MRI (DWI) for breast imaging. This technique has shown promise for improving the positive predictive value of breast MRI for detection of breast cancer, evaluating tumor response to neoadjuvant chemotherapy, and as a non-contrast MRI alternative for breast cancer screening. However, there is currently no standardized approach to DWI of the breast and data quality varies widely. Prior to implementing DWI into clinical practice...

  15. Acupuncture for treating alopecia areata: a protocol of systematic review of randomised clinical trials

    OpenAIRE

    Lee, Hye Won; Jun, Ji Hee; Lee, Ju Ah; Lim, Hyun-Ja; Lim, Hyun-Suk; Lee, Myeong Soo

    2015-01-01

    Introduction Acupuncture is frequently used in dermatology for treating a number of skin disorders. There is no critically appraised evidence of the potential benefits and harm of acupuncture for alopecia areata (AA). This review aims to systematically evaluate the efficacy of acupuncture for the management of AA in randomised clinical trials (RCTs). Methods and analysis 13 databases will be searched from their inception. These include PubMed, AMED, EMBASE, the Cochrane Library, 6 Korean medi...

  16. Randomized clinical trial of the timing it right stroke family support program: research protocol

    OpenAIRE

    Jill I. Cameron; Naglie, Gary; Gignac, Monique A M; Bayley, Mark; Warner, Grace; Green, Theresa; Czerwonka, Anna; Huijbregts, Maria; Silver, Frank L; Phillips, Steve J; Cheung, Angela M.

    2014-01-01

    Background Family caregivers provide invaluable support to stroke survivors during their recovery, rehabilitation, and community re-integration. Unfortunately, it is not standard clinical practice to prepare and support caregivers in this role and, as a result, many experience stress and poor health that can compromise stroke survivor recovery and threaten the sustainability of keeping the stroke survivor at home. We developed the Timing it Right Stroke Family Support Program (TIRSFSP) to gui...

  17. Study protocol: The registrar clinical encounters in training (ReCEnT study

    Directory of Open Access Journals (Sweden)

    Morgan Simon

    2012-06-01

    Full Text Available Abstract Background Patient encounters are the core learning activity of Australian general practice (family practice training. Exposure to patient demographics and presentations may vary from one general practice registrar (vocational trainee to another. This can affect comprehensiveness of training. Currently, there is no mechanism to systematically capture the content of GP registrar consultations. The aim of the Registrar Clinical Encounters in Training (ReCEnT study is to document longitudinally the nature and associations of consultation-based clinical and educational experiences of general practice registrars. Methods/design This is an ongoing prospective multi-site cohort study of general practice registrars’ consultations, entailing paper-based recording of consultation data. The study setting is general practices affiliated with three geographically-based Australian general practice regional training providers. Registrars record details of 60 consecutive consultations. Data collected includes registrar demographics, details of the consultation, patient demographics, reasons for encounter and problems managed. Problems managed are coded with the International Classification of Primary Care (second edition classification system. Additionally, registrars record educational factors related to the encounter. The study will follow the clinical exposure of each registrar six-monthly over the 18 months to two years (full-time equivalent of their general practice training program. Conclusions The study will provide data on a range of factors (patient, registrar and consultation factors. This data will be used to inform a range of educational decisions as well as being used to answer educational research questions. We plan to use ReCEnT as a formative assessment tool for registrars and help identify and address educational needs. The study will facilitate program evaluation by the participating training providers and thus improve articulation

  18. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

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    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  19. Clinical grade purification and expansion of NK cell products for an optimized manufacturing protocol

    Directory of Open Access Journals (Sweden)

    UlrikeKoehl

    2013-05-01

    Full Text Available Allogeneic Natural Killer (NK cells are used for adoptive immunotherapy after stem cell transplantation. In order to overcome technical limitations in NK cell purification and activation, the following study investigates the impact of different variables on NK cell recovery, cytotoxicity and T cell depletion during GMP-grade NK cell selection. 40 NK cell products were derived from 54 unstimulated donor leukaphereses using immunomagnetic CD3 T-cell depletion, followed by a CD56 cell enrichment step. For T cell depletion, either the depletion 2.1 program in single or double procedure (D2.1 1depl, n=18; D2.1 2depl, n=13 or the faster depletion 3.1 (D3.1, n=9 was used on the CliniMACS instrument. 17 purified NK cell products were activated in vitro by IL-2 for 12 days. The whole process resulted in a median number of 7.59x10e8 CD56+CD3- cells with both purity and viability of 94%, respectively. The T-cell depletion was significantly better using D2.1 1depl/2depl compared to D3.1 (log 4.6/log 4.9 vs. log 3.7; p<0.01 and double procedure in two stages led always to residual T cells below 0.1%. In contrast D3.1 was superior to D2.1 1depl/2depl with regard to recovery of CD56+CD3- NK cells (68% vs 41%/38%. Concomitant monocytes and especially IL-2 activation led to increased NK cell activity against malignant target cells compared to unstimulated NK cells, which correlated with both up-regulation of natural cytotoxicity receptors and intracellular signaling. Overall, wide variations in the NK cell expansion rate and the distribution of NK cell subpopulations were found. In conclusion, our results indicate that GMP-grade purification of NK cells might be improved by a sequential processing of T cell depletion program D2.1 and D3.1. In addition NK cell expansion protocols need to be further optimized.

  20. Organisation and management of the first clinical trial of BNCT in Europe (EORTC Protocol 11961)

    International Nuclear Information System (INIS)

    Boron Neutron Capture Therapy is based on the ability of the isotope 10B to capture thermal neutrons and to disintegrate instantaneously producing high LET particles. The only neutron beam available in Europe for such a treatment is based at the European High Flux Reactor HFR at Petten (The Netherlands). The European Commission, owners of the reactor, decided that the potential benefit of the facility should be opened to all European citizens and therefore insisted on a multinational approach to perform the first clinical trial in Europe on BNCT. This precondition had to be respected as well as the national laws and regulations. Together with the Dutch authorities actions were undertaken to overcome the obvious legal problems. Furthermore, the clinical trial at Petten takes place in a nuclear research reactor, which apart from being conducted in a non-hospital environment, is per se known to be dangerous. It was therefore of the utmost importance that special attention is given to safety, beyond normal rules, and to the training of staff. In itself, the trial is an unusual Phase I study, introducing a new drug with a new irradiation modality, with really an unknown dose-effect relationship. This trial must follow optimal procedures, which underscore the quality and qualified manner of performance. (orig.)

  1. Perfusion computed tomography in colorectal cancer: Protocols, clinical applications and emerging trends

    Institute of Scientific and Technical Information of China (English)

    Guang-Yao Wu; Prasanna Ghimire

    2009-01-01

    Perfusion computed tomography (CT) has emerged as a novel functional imaging technique with gradually increasing importance in the management of colorectal cancer (CRC). By providing the functional tumor microvasculature, it also helps the assessment of therapeutic response of anti-angiogenic drugs as it may reflect tumor angiogenesis. Perfusion CT has been applied in clinical practice to delineate inflammatory or neoplastic lymph nodes irrespective of their size,identify micro-metastases and to predict metastases in advance of their development. It is of increasing significance for preoperative adjuvant therapies and avoidance of unnecessary interventions. Despite controversies regarding the techniques employed, its validity and reproducibility, it can be advantageous in the management of CRCs in which the prognosis is dependent on preoperative staging. With recent advances in the perfusion CT techniques, and incorporation to other modalities like positron emission tomography, perfusion CT will be a novel tool in the overall management of CRCs. This article aims at reviewing the existing clinical applications and recent advances of perfusion CT with a reference to future development in the management of CRCs.

  2. Influence of societal and practice contexts on health professionals’ clinical reasoning: a scoping study protocol

    Science.gov (United States)

    Carrier, Annie; Levasseur, Mélanie; Freeman, Andrew; Mullins, Gary; Quénec'hdu, Suzanne; Lalonde, Louise; Gagnon, Michaël; Lacasse, Francis

    2013-01-01

    Introduction In a context of constrained resources, the efficacy of interventions is a pivotal aim of healthcare systems worldwide. Efficacy of healthcare interventions is highly compromised if clinical reasoning (CR), the process that practitioners use to plan, direct, perform and reflect on client care, is not optimal. The CR process of health professionals is influenced by the institutional dimension (ie, legal, regulatory, administrative and organisational aspects) of their societal and practice contexts. Although several studies have been conducted with respect to the institutional dimension influencing health professionals’ CR, no clear integration of their results is yet available. The aim of this study is to synthesise and disseminate current knowledge on the influence of the institutional dimension of contexts on health professionals’ CR. Methods and analysis A scoping study of the scientific literature from January 1980 to March 2013 will be undertaken to summarise and disseminate research findings about the influence of the institutional dimension on CR. Numerous databases (n=18) from three relevant fields (healthcare, health law and politics and management) will be searched. Extended search strategies will include the manual search of bibliographies, health-related websites, public registries and journals of interest. Data will be collected and analysed using a thematic chart and content analysis. A systematic multidisciplinary team approach will allow optimal identification of relevant studies, as well as effective and valid content analysis and dissemination of the results. Discussion This scoping study will provide a rigorous, accurate and up-to-date synthesis of existing knowledge regarding: (1) those aspects of the institutional dimension of health professionals’ societal and practice contexts that impact their CR and (2) how these aspects influence health professionals’ CR. Through the synergy of a multidisciplinary research team from a

  3. International Study to Predict Optimized Treatment for Depression (iSPOT-D, a randomized clinical trial: rationale and protocol

    Directory of Open Access Journals (Sweden)

    Cooper Nicholas J

    2011-01-01

    Full Text Available Abstract Background Clinically useful treatment moderators of Major Depressive Disorder (MDD have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators. Methods/Design The International Study to Predict Optimized Treatment - in Depression (iSPOT-D is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65 from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls. Study-eligible patients are antidepressant medication (ADM naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary. Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm. Discussion First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide. Trial registration International Study to Predict Optimised Treatment - in Depression (iSPOT-D ClinicalTrials.gov Identifier

  4. GENetic and clinical Predictors Of treatment response in Depression: the GenPod randomised trial protocol

    Directory of Open Access Journals (Sweden)

    O'Donovan Michael

    2008-05-01

    Full Text Available Abstract Background The most effective pharmacological treatments for depression inhibit the transporters that reuptake serotonin (Selective Serotonin Reuptake Inhibitors – SSRIs and noradrenaline (Noradrenaline Reuptake Inhibitors – NaRIs into the presynaptic terminal. There is evidence to suggest that noradrenaline and serotonin enhancing drugs work through separate mechanisms to produce their clinical antidepressant action. Although most of the current evidence suggests there is little difference in overall efficacy between SSRIs and NaRIs, there are patients who respond to one class of compounds and not another. This suggests that treatment response could be predicted by genetic and/or clinical characteristics. Firstly, this study aims to investigate the influence of a polymorphism (SLC6A4 in the 5HT transporter in altering response to SSRI medication. Secondly, the study will investigate whether those with more severe depression have a better response to NaRIs than SSRIs. Methods/design The GenPod trial is a multi-centre randomised controlled trial. GPs referred patients aged between 18–74 years presenting with a new episode of depression, who did not have any medical contraindications to antidepressant medication and who had no history of psychosis or alcohol/substance abuse. Patients were interviewed to ascertain their suitability for the study. Eligible participants (with a primary diagnosis of depression according to ICD10 criteria and a Beck Depression Inventory (BDI score > 14 were randomised to receive one of two antidepressant treatments, either the SSRI Citalopram or the NaRI Reboxetine, stratified according to severity. The final number randomised to the trial was 601. Follow-up assessments took place at 2, 6 and 12 weeks following randomisation. Primary outcome was measured at 6 weeks by the BDI. Outcomes will be analysed on an intention-to-treat basis and will use multiple regression models to compare treatments

  5. Combined PET - CT and PET - MRI imaging from non hybrid cameras: Protocol approaches and clinical experience

    International Nuclear Information System (INIS)

    In this presentation, we describe our experience with different approaches on PET-CT and PET-MRI alignment and display, analysing the performance of all the registration tools available at the Nuclear Medicine School Foundation, the impact of those tools and the necessary troubleshooting during implementation. Those tools include the development of our own software for automatic registration with different algorithms, and the use of available commercial ones front several branches. We found registration using fiducial or anatomical landmarks are unacceptable for clinical practice. Manual registration is feasible, though is time consuming, and needs to be performed by trained staff, preferably checked or performed by the reader at the reading room. Automatic Registration has today more acceptance. The method of choice in mutual information, described elsewhere. It needs little training for software manipulation and no anatomical familiarity from the operator. Currently, the author's preference is to run a mutual information registration, and personally check and correct manually minor inter modality discrepancies while reading each study

  6. Current protocols in the generation of pluripotent stem cells: theoretical, methodological and clinical considerations

    Directory of Open Access Journals (Sweden)

    Brad B Swelstad

    2009-12-01

    Full Text Available Brad B Swelstad, Candace L KerrInstitute for Cell Engineering, Department of Obstetrics and Gynecology, Johns Hopkins University, Baltimore, MA, USAAbstract: Pluripotent stem cells have been derived from various embryonic, fetal and adult sources. Embryonic stem cells (ESCs and parthenogenic ESCs (pESCs are derived from the embryo proper while embryonic germ cells (EGCs, embryonal carcinoma cells (ECCs, and germ-line stem cells (GSC are produced from germ cells. ECCs were the first pluripotent stem cell lines established from adult testicular tumors while EGCs are generated in vitro from primordial germ cells (PGCs isolated in late embryonic development. More recently, studies have also demonstrated the ability to produce GSCs from adult germ cells, known as spermatogonial stem cells. Unlike ECCs, the source of GSCs are normal, non-cancerous adult tissue. The study of these unique cell lines has provided information that has led to the ability to reprogram somatic cells into an ESC-like state. These cells, called induced pluripotent stem cells (iPSCs, have been derived from a number of human fetal and adult origins. With the promises pluripotent stem cells bring to cell-based therapies there remain several considerations that need to be carefully studied prior to their clinical use. Many of these issues involve understanding key factors regulating their generation, including those which define pluripotency. In this regard, the following article discusses critical aspects of pluripotent stem cell derivation and current issues about their therapeutic potential.Keywords: pluripotency, stem cells, derivation, human

  7. The Effectiveness of Individualized Acupuncture Protocols in the Treatment of Gulf War Illness: A Pragmatic Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Lisa Conboy

    Full Text Available Gulf War Illness is a Complex Medical Illness characterized by multiple symptoms, including fatigue, sleep and mood disturbances, cognitive dysfunction, and musculoskeletal pain affecting veterans of the first Gulf War. No standard of care treatment exists.This pragmatic Randomized Clinical Trial tested the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness were randomized to either six months of biweekly acupuncture treatments (group 1, n = 52 or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n = 52. Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P and the secondary outcome is the McGill Pain scale.Of the 104 subjects who underwent randomization, 85 completed the protocol (82%. A clinically and statistically significant average improvement of 9.4 points (p = 0.03 in the SF-36P was observed for group 1 at month 6 compared to group 2, adjusting for baseline pain. The secondary outcome of McGill pain index produced similar results; at 6 months, group 1 was estimated to experience a reduction of approximately 3.6 points (p = 0.04 compared to group 2.Individualized acupuncture treatment of sufficient dose appears to offer significant relief of physical disability and pain for veterans with Gulf War Illness. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Gulf War Illness Research Program under Award No. W81XWH-09-2-0064. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.ClinicalTrials.gov NCT01305811.

  8. Passive movement therapy in patients with moderate to severe paratonia; study protocol of a randomised clinical trial (ISRCTN43069940

    Directory of Open Access Journals (Sweden)

    de Bie Rob A

    2007-12-01

    Full Text Available Abstract Background Paratonia, a form of hypertonia, is associated with loss of mobility and with the development of contractures especially in the late stages of the dementia. Passive movement therapy (PMT currently is the main physiotherapeutic intervention. General doubt about the beneficial effects of this widely used therapy necessitates a randomised clinical trial (RCT to study the efficacy of PMT on the severity of paratonia and on the improvement of daily care. Methods/Design A RCT with a 4-week follow-up period. Patients with dementia (according to the DSM-IV-TR Criteria and moderate to severe paratonia are included in the study after proxy consent. By means of computerised and concealed block randomisation (block-size of 4 patients are included in one of two groups. The first group receives PMT, the second group receives usual care without PMT. PMT is given according to a protocol by physical therapist three times a week for four weeks in a row. The severity of paratonia (Modified Ashworth scale, the severity of the dementia (Global Deterioration Scale, the clinical improvement (Clinical Global Impressions, the difficulty in daily care (Patient Specific Complaints and the experienced pain in daily care of the participant (PACSLAC-D is assessed by assessors blind to treatment allocation at baseline, after 6 and 12 treatments. Success of the intervention is defined as a significant increase of decline on the modified Ashworth scale. The 'proportion of change' in two and four weeks time on this scale will be analysed. Also a multiple logistic regression analysis using declined/not declined criteria as dependent variable with correction for relevant confounders (e.g. stage of dementia, medication, co-morbidity will be used. Discussion This study is the first RCT of this size to gain further insight on the effect of passive movement therapy on the severity of paratonia. Trial registration Current Controlled Trials ISRCTN43069940

  9. Hepatocellular carcinoma: From clinical practice to evidence-based treatment protocols

    Institute of Scientific and Technical Information of China (English)

    Danijel; Galun; Dragan; Basaric; Marinko; Zuvela; Predrag; Bulajic; Aleksandar; Bogdanovic; Nemanja; Bidzic; Miroslav; Milicevic

    2015-01-01

    Hepatocellular carcinoma(HCC) is one of the major malignant diseases in many healthcare systems. The growing number of new cases diagnosed each year is nearly equal to the number of deaths from this cancer. Worldwide, HCC is a leading cause of cancerrelated deaths, as it is the fifth most common cancer and the third most important cause of cancer related death in men. Among various risk factors the two are prevailing: viral hepatitis, namely chronic hepatitis C virus is a well-established risk factor contributing to the rising incidence of HCC. The epidemic of obesity and the metabolic syndrome, not only in the United States but also in Asia, tend to become the leading cause of the long-term rise in the HCC incidence. Today, the diagnosis of HCC is established within the national surveillance programs in developed countries while the diagnosis of symptomatic, advanced stage disease still remains the characteristic of underdeveloped countries. Although many different staging systems have been developed and evaluated the BarcelonaClinic Liver Cancer staging system has emerged as the most useful to guide HCC treatment. Treatment allocation should be decided by a multidisciplinary board involving hepatologists, pathologists, radiologists, liver surgeons and oncologists guided by personalized-based medicine. This approach is important not only to balance between different oncologic treatments strategies but also due to the complexity of the disease(chronic liver disease and the cancer) and due to the large number of potentially efficient therapies. Careful patient selection and a tailored treatment modality for every patient, either potentially curative(surgical treatment and tumor ablation) or palliative(transarterial therapy, radioembolization and medical treatment, i.e., sorafenib) is mandatory to achieve the best treatment outcome.

  10. The functional and clinical outcomes of exercise training following a very low energy diet for severely obese women: study protocol for a randomised controlled trial

    OpenAIRE

    Miller, Clint T.; Fraser, Steve F; Selig, Steve E; Rice, Toni; Grima, Mariee; Straznicky, Nora E.; Levinger, Itamar; Lambert, Elisabeth A.; van den Hoek, Daniel J.; Dixon, John B.

    2016-01-01

    Background Clinical practice guidelines globally recommend lifestyle modification including diet and exercise training as first-line treatment for obesity. The clinical benefits of exercise training in adults with obesity is well-documented; however, there is no strong evidence for the effectiveness of exercise training for weight loss in class II and class III obesity. The purpose of the randomised controlled trial described in this protocol article is to examine the effect of exercise train...

  11. The Effect of Absenteeism and Clinic Protocol on Health Outcomes: The Case of Mother-to-Child Transmission of HIV in Kenya

    OpenAIRE

    Goldstein, Markus; Graff Zivin, Joshua; Habyarimana, James; Pop-Eleches, Cristian; THIRUMURTHY, Harsha

    2013-01-01

    Absenteeism of health workers in developing countries is widespread with some estimates indicating rates of provider absence of nearly 40% (Chaudhury et. al. 2006). This is the first paper to present evidence of the impact of health provider absence combined with limitations in health clinic protocol on health outcomes. Using longitudinal data from nearly 600 ante-natal care seekers at a rural ante-natal clinic in Western Kenya, we find that nurse absence on a patient’s first visit significan...

  12. Surgical Protocol and Short-Term Clinical Outcome of Immediate Placement in Molar Extraction Sockets Using a Wide Body Implant

    Directory of Open Access Journals (Sweden)

    Stefan Vandeweghe

    2011-08-01

    Full Text Available Objectives: Implant placement in molar extraction sockets can be difficult due to complex multi-root anatomy and the lack of predictable primary stability. The aim of this study was to evaluate the outcome of an 8 - 9 mm diameter tapered implant, designed to be placed in molar extraction sockets.Material and methods: Patients treated at least 1 year before with a Max® implant (Southern Implants, Irene, South Africa were invited for a clinical examination. Variables collected were surgical and prosthetic protocol, implant dimension and smoking habits. Peri-implant bone level was determined on peri-apical radiographs and compared to baseline, being implant insertion.Results: 98 implants had been placed in 89 patients. One implant had failed. Thirty eight patients representing 47 implants (maxilla 26, mandible 21 were available for clinical examination. Mean bone loss was 0.38 mm (SD 0.48; range - 0.50 – 1.95 after a mean follow-up of 20 months (range 12 - 35. Implant success was 97.9%. Around 30 implants, a bone substitute was used to fill the residual space, but this did not affect the bone loss outcome. Bone loss was only significantly different between maxilla and mandible (0.48 mm vs. 0.27 mm and between the 8 and 9 mm diameter implants (0.23 mm vs. 0.55 mm. A full papilla was present at 71% of the interproximal sites and irrespective of bone loss.Conclusions: The Max® implant demonstrated good primary stability, when placed in molar extraction sockets, with limited bone loss over time.

  13. Parents as Agents of Change (PAC in pediatric weight management: The protocol for the PAC randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Ball Geoff D C

    2012-08-01

    Full Text Available Abstract Background There is an urgent need to develop and evaluate weight management interventions to address childhood obesity. Recent research suggests that interventions designed for parents exclusively, which have been named parents as agents of change (PAC approaches, have yielded positive outcomes for managing pediatric obesity. To date, no research has combined a PAC intervention approach with cognitive behavioural therapy (CBT to examine whether these combined elements enhance intervention effectiveness. This paper describes the protocol our team is using to examine two PAC-based interventions for pediatric weight management. We hypothesize that children with obesity whose parents complete a CBT-based PAC intervention will achieve greater reductions in adiposity and improvements in cardiometabolic risk factors, lifestyle behaviours, and psychosocial outcomes than children whose parents complete a psycho-education-based PAC intervention (PEP. Methods/Design This study is a pragmatic, two-armed, parallel, single-blinded, superiority, randomized clinical trial. The primary objective is to examine the differential effects of a CBT-based PAC vs PEP-based PAC intervention on children’s BMI z-score (primary outcome. Secondary objectives are to assess intervention-mediated changes in cardiometabolic, lifestyle, and psychosocial variables in children and parents. Both interventions are similar in frequency of contact, session duration, group facilitation, lifestyle behaviour goals, and educational content. However, the interventions differ insofar as the CBT-based intervention incorporates theory-based concepts to help parents link their thoughts, feelings, and behaviours; these cognitive activities are enabled by group leaders who possess formal training in CBT. Mothers and fathers of children (8–12 years of age; BMI ≥85th percentile are eligible to participate if they are proficient in English (written and spoken and agree for at least

  14. Suicide Risk Protocols: Addressing the Needs of High Risk Youths Identified through Suicide Prevention Efforts and in Clinical Settings

    Science.gov (United States)

    Heilbron, Nicole; Goldston, David; Walrath, Christine; Rodi, Michael; McKeon, Richard

    2013-01-01

    Several agencies have emphasized the importance of establishing clear protocols or procedures to address the needs of youths who are identified as suicidal through suicide prevention programs or in emergency department settings. What constitutes optimal guidelines for developing and implementing such protocols, however, is unclear. At the request…

  15. Varied Search Protocols Lead to Clinically Relevant Results. A review of: Patel, Manesh R., Connie M. Schardt, Linda L. Sanders, and Sheri A. Keitz. “Randomized Trial for Answers to Clinical Questions: Evaluating a Pre‐Appraised Versus a MEDLINE Search Protocol.” Journal of the Medical Library Association 94.4 (2006: 382‐6.

    Directory of Open Access Journals (Sweden)

    Marcy L. Brown

    2008-03-01

    Full Text Available Objective – To determine the success rate of electronic resources for answering clinical questions by comparing speed, validity, and applicability of two different protocols for searching the medical literature.Design – Randomized trial with results judged by blinded panel.Setting – Duke University Medical Center in Durham, North Carolina, United States ofAmerica.Subjects – Thirty‐two 2nd and 3rd year internal medicine residents on an eight week general medicine rotation at the Duke University Medical Center.Methods – Two search protocols were developed:Protocol A: Participants searched MEDLINE first, and then searched pre‐appraised resources if needed.Protocol B: Participants searched pre‐appraised resources first, which included UpToDate, ACP JournalClub, Cochrane Database of Systematic Reviews, and DARE. The residents then searched MEDLINE if an answer could not be found in the 66 initial group of pre‐appraised resources. Residents were randomised by computer-assisted block order into four blocks of eight residents each. Two blocks were assigned to Protocol A, and two to Protocol B. Each day, residents developed at least one clinical question related to caring for patients. The questions were transcribed onto pocket-sized cards, with the answer sought later using the assigned protocol. If answers weren’t found using either protocol, searches were permitted in other available resources. When an article that answered a question was found, the resident recorded basic information about the question and the answer as well as the time required to find the answer (less than five minutes; between five and ten minutes; or more than ten minutes. Residents were to select answers that were “methodologically sound and clinically important” (384. Ten faculty members formally trained in evidence‐based medicine (EBM reviewed a subset of therapy‐related questions and answers. The reviewers, who were blinded to the search protocols

  16. Manufacturing and use of human placenta-derived mesenchymal stromal cells for phase I clinical trials: Establishment and evaluation of a protocol

    Directory of Open Access Journals (Sweden)

    Ilić Nina

    2014-01-01

    Full Text Available Background/Aim. Mesenchymal stromal cells (MSCs have been utilised in many clinical trials as an experimental treatment in numerous clinical settings. Bone marrow remains the traditional source tissue for MSCs but is relatively hard to access in large volumes. Alternatively, MSCs may be derived from other tissues including the placenta and adipose tissue. In an initial study no obvious differences in parameters such as cell surface phenotype, chemokine receptor display, mesodermal differentiation capacity or immunosuppressive ability, were detected when we compared human marrow derived- MSCs to human placenta-derived MSCs. The aim of this study was to establish and evaluate a protocol and related processes for preparation placenta-derived MSCs for early phase clinical trials. Methods. A full-term placenta was taken after delivery of the baby as a source of MSCs. Isolation, seeding, incubation, cryopreservation of human placentaderived MSCs and used production release criteria were in accordance with the complex regulatory requirements applicable to Code of Good Manufacturing Practice manufacturing of ex vivo expanded cells. Results. We established and evaluated instructions for MSCs preparation protocol and gave an overview of the three clinical areas application. In the first trial, MSCs were co-transplanted iv to patient receiving an allogeneic cord blood transplant as therapy for treatmentrefractory acute myeloid leukemia. In the second trial, MSCs were administered iv in the treatment of idiopathic pulmonary fibrosis and without serious adverse effects. In the third trial, MSCs were injected directly into the site of tendon damage using ultrasound guidance in the treatment of chronic refractory tendinopathy. Conclusion. Clinical trials using both allogeneic and autologous cells demonstrated MSCs to be safe. A described protocol for human placenta-derived MSCs is appropriate for use in a clinical setting, relatively inexpensive and can be

  17. A Structured Protocol Model of Depression Care versus Clinical Acumen: A Cluster Randomized Trial of the Effects on Depression Screening, Diagnostic Evaluation, and Treatment Uptake in Ugandan HIV Clinics

    Science.gov (United States)

    Wagner, Glenn J.; Ngo, Victoria; Goutam, Prodyumna; Glick, Peter; Musisi, Seggane; Akena, Dickens

    2016-01-01

    Depression is common among people living with HIV, and it has consequences for both HIV prevention and treatment response, yet depression treatment is rarely integrated into HIV care in sub-Saharan Africa, partly due to the paucity of mental health professionals. We conducted a cluster randomized controlled trial of two task-shifting models to facilitating depression care delivered by medical providers: one that utilized a structured protocol, and one that relied on clinical acumen, in 10 HIV clinics in Uganda. Both models started with routine depression screening of all clients at triage using the 2-item Patient Health Questionnaire (PHQ-2), from which we enrolled 1252 clients (640 at structured protocol clinics, 612 at clinical acumen clinics) who had screened positive over 12 months. We compared the two models on (1) proportion of all client participants, and those clinically depressed (based on survey-administered 9-item PHQ-9>9), who received post-screening evaluation for depression using the PHQ-9; and (2) proportion of clinically depressed who were prescribed antidepressant therapy. Linear probability regression analyses were conducted using a wild cluster bootstrap to control for clustering; patient characteristics, clinic size and time fixed effects were included as covariates. Among all client participants, those in the structured protocol arm were far more likely to have received further evaluation by a medical provider using the PHQ-9 (84% vs. 49%; beta = .33; p = .01). Among the clinically depressed clients (n = 369), the advantage of the structured protocol model over clinical acumen was not statistically significant with regard to PHQ-9 depression evaluation (93% vs. 68%; beta = .21; p = .14) or prescription of antidepressants (69% vs. 58%; beta = .10; p = .50), in part because only 30% of clients who screened positive were clinically depressed. These findings reveal that in both models depression care practices were widely adopted by providers, and

  18. Welfare assessment: correlations and integration between a Qualitative Behavioural Assessment and a clinical/health protocol applied in veal calves farms

    OpenAIRE

    van Reenen, Cornelis G; Giulio Cozzi; Elena Tessitore; Marta Brscic; Francoise Wemelsfelder; Flaviana Gottardo

    2009-01-01

    This study is aimed at finding correlations and possible integration among Qualitative Behavioural Assessment (QBA) and a specific protocol of clinical/health evaluation. Both welfare assessment methods were based on direct animal observation and were applied in 24 Italian veal calves farms at 3 weeks (wks) of rearing. Principal component analysis (PCA) summarized 20 QBA descriptors on two main components (PC1 and PC2) with eigenvalues above 4 and explaining 29.6 and 20.3% of the variation re...

  19. Data for improvement and clinical excellence: protocol for an audit with feedback intervention in home care and supportive living

    Directory of Open Access Journals (Sweden)

    Fraser Kimberly D

    2012-01-01

    Full Text Available Abstract Background Although considerable evidence exists about the effectiveness of audit coupled with feedback, very few audit-with-feedback interventions have been done in either home care or supportive living settings to date. With little history of audit and feedback in home care or supportive living there is potential for greater effects, at least initially. This study extends the work of an earlier study designed to assess the effects of an audit-with-feedback intervention. It will be delivered quarterly over a one-year period in seven home care offices and 11 supportive living sites. The research questions are the same as in the first study but in a different environment. They are as follows: 1. What effects do feedback reports have on processes and outcomes over time? 2. How do different provider groups in home care and supportive living sites respond to feedback reports based on quality indicator data? Methods The research team conducting this study includes researchers and decision makers in continuing care in the province of Alberta, Canada. The intervention consists of quarterly feedback reports in 19 home care offices and supportive living sites across Alberta. Data for the feedback reports are based on the Resident Assessment Instrument Home Care tool, a standardized instrument mandated for use in home care and supportive living environments throughout Alberta. The feedback reports consist of one page, printed front and back, presenting both graphic and textual information. Reports are delivered to all employees working in each site. The primary evaluation uses a controlled interrupted time-series design, both adjusted and unadjusted for covariates. The concurrent process evaluation includes observation, focus groups, and self-reports to assess uptake of the feedback reports. The project described in this protocol follows a similar intervention conducted in our previous study, Data for Improvement and Clinical Excellence

  20. Simplified protocol for clinical-grade tumor-infiltrating lymphocyte manufacturing with use of the Wave bioreactor

    DEFF Research Database (Denmark)

    Donia, Marco; Larsen, Signe Møllebæk; Met, Ozcan;

    2014-01-01

    BACKGROUND AIMS: The high level of complexity of current Good Manufacturing Practice-compliant methods of manufacturing hampers rapid and broad application of treatment with tumor-infiltrating lymphocytes (TILs). METHODS: To ensure higher applicability of TIL production to laboratory routine......, a practical and simple protocol of TIL manufacturing with the use of a closed-system bioreactor was developed and implemented at our institution. RESULTS: This protocol enabled significant work load reduction during the most labor-intense step of TIL expansion, and allowed generation of high-quality TIL...

  1. The influence of different contrast medium concentrations and injection protocols on quantitative and clinical assessment of FDG–PET/CT in lung cancer

    Energy Technology Data Exchange (ETDEWEB)

    Verburg, Frederik A., E-mail: fverburg@ukaachen.de [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany); Maastricht University Medical Center, Department of Nuclear Medicine, P. Debyelaan 25, 6229 HX Maastricht (Netherlands); Kuhl, Christiane K. [RWTH Aachen University Hospital, Department of Diagnostic and Interventional Radiology, Pauwelsstraße 30, 52074 Aachen (Germany); Pietsch, Hubertus [Bayer Pharma AG, Berlin, Müllerstrasse 178, 13353 Berlin (Germany); Palmowski, Moritz [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany); Mottaghy, Felix M. [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany); Maastricht University Medical Center, Department of Nuclear Medicine, P. Debyelaan 25, 6229 HX Maastricht (Netherlands); Behrendt, Florian F. [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany)

    2013-10-01

    Objectives: To compare the effects of two different contrast medium concentrations for use in computed X-ray tomography (CT) employing two different injection protocols on positron emission tomography (PET) reconstruction in combined 2-{sup 18}F-desoxyglucose (FDG) PET/CT in patients with a suspicion of lung cancer. Methods: 120 patients with a suspicion of lung cancer were enrolled prospectively. PET images were reconstructed with the non-enhanced and venous phase contrast CT obtained after injection of iopromide 300 mg/ml or 370 mg/ml using either a fixed-dose or a body surface area adapted injection protocol. Maximum and mean standardized uptake values (SUVmax and SUVmean) and contrast enhancement (HU) were determined in the subclavian vein, ascending aorta, abdominal aorta, inferior vena cava, portal vein, liver and kidney and in the suspicious lung lesion. PET data were evaluated visually for the presence of malignancy and image quality. Results: At none of the sites a significant difference in the extent of the contrast enhancement between the four different protocols was found. However, the variability of the contrast enhancement at several anatomical sites was significantly greater in the fixed dose groups than in the BSA groups for both contrast medium concentrations. At none of the sites a significant difference was found in the extent of the SUVmax and SUVmean increase as a result of the use of the venous phase contrast enhanced CT for attenuation. Visual clinical evaluation of lesions showed no differences between contrast and non-contrast PET/CT (P = 0.32). Conclusions: Contrast enhanced CT for attenuation correction in combined PET/CT in lung cancer affects neither the clinical assessment nor image quality of the PET-images. A body surface adapted contrast medium protocol reduces the interpatient variability in contrast enhancement.

  2. The influence of different contrast medium concentrations and injection protocols on quantitative and clinical assessment of FDG–PET/CT in lung cancer

    International Nuclear Information System (INIS)

    Objectives: To compare the effects of two different contrast medium concentrations for use in computed X-ray tomography (CT) employing two different injection protocols on positron emission tomography (PET) reconstruction in combined 2-18F-desoxyglucose (FDG) PET/CT in patients with a suspicion of lung cancer. Methods: 120 patients with a suspicion of lung cancer were enrolled prospectively. PET images were reconstructed with the non-enhanced and venous phase contrast CT obtained after injection of iopromide 300 mg/ml or 370 mg/ml using either a fixed-dose or a body surface area adapted injection protocol. Maximum and mean standardized uptake values (SUVmax and SUVmean) and contrast enhancement (HU) were determined in the subclavian vein, ascending aorta, abdominal aorta, inferior vena cava, portal vein, liver and kidney and in the suspicious lung lesion. PET data were evaluated visually for the presence of malignancy and image quality. Results: At none of the sites a significant difference in the extent of the contrast enhancement between the four different protocols was found. However, the variability of the contrast enhancement at several anatomical sites was significantly greater in the fixed dose groups than in the BSA groups for both contrast medium concentrations. At none of the sites a significant difference was found in the extent of the SUVmax and SUVmean increase as a result of the use of the venous phase contrast enhanced CT for attenuation. Visual clinical evaluation of lesions showed no differences between contrast and non-contrast PET/CT (P = 0.32). Conclusions: Contrast enhanced CT for attenuation correction in combined PET/CT in lung cancer affects neither the clinical assessment nor image quality of the PET-images. A body surface adapted contrast medium protocol reduces the interpatient variability in contrast enhancement

  3. Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care - study protocol for a randomized clinical trial

    DEFF Research Database (Denmark)

    Eklund, Andreas; Axén, Iben; Kongsted, Alice;

    2014-01-01

    of deterioration (tertiary prevention), is equally important. Research has largely focused on treatment methods for symptomatic episodes, and little is known about preventive treatment strategies. METHODS: This study protocol describes a randomized controlled clinical trial in a multicenter setting...... investigating the effect and cost-effectiveness of preventive manual care (chiropractic maintenance care) in a population of patients with recurrent or persistent LBP.Four hundred consecutive study subjects with recurrent or persistent LBP will be recruited from chiropractic clinics in Sweden. The primary...... utility measure of the study is quality-adjusted life years and will be calculated using the EQ-5D questionnaire. Direct medical costs as well as indirect costs will be considered.Subjects are randomly allocated into two treatment arms: 1) Symptom-guided treatment (patient controlled), receiving care when...

  4. Clinical evaluation of dengue and identification of risk factors for severe disease : protocol for a multicentre study in 8 countries

    NARCIS (Netherlands)

    Jaenisch, Thomas; Tam, Dong Thi Hoai; Kieu, Nguyen Tan Thanh; Van Ngoc, Tran; Nam, Nguyen Tran; Van Kinh, Nguyen; Yacoub, Sophie; Chanpheaktra, Ngoun; Kumar, Varun; See, Lucy Lum Chai; Sathar, Jameela; Sandoval, Ernesto Pleités; Alfaro, Gabriela Maria Marón; Laksono, Ida Safitri; Mahendradhata, Yodi; Sarker, Malabika; Ahmed, Firoz; Caprara, Andrea; Benevides, Bruno Souza; Marques, Ernesto T A; Magalhaes, Tereza; Brasil, Patricia; Netto, Marco; Tami, Adriana; Bethencourt, Sarah E; Guzman, Maria; Simmons, Cameron; Quyen, Nguyen Thanh Ha; Merson, Laura; Dung, Nguyen Thi Phuong; Beck, Dorothea; Wirths, Marius; Wolbers, Marcel; Lam, Phung Khanh; Rosenberger, Kerstin; Wills, Bridget

    2016-01-01

    BACKGROUND: The burden of dengue continues to increase globally, with an estimated 100 million clinically apparent infections occurring each year. Although most dengue infections are asymptomatic, patients can present with a wide spectrum of clinical symptoms ranging from mild febrile illness throug

  5. Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol

    Directory of Open Access Journals (Sweden)

    Pérula-de-Torres LuisÁ

    2012-10-01

    Full Text Available Abstract Background Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. Methods/design An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group. As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group. Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis. Discussion If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. Trial registration The study is registered as NCT01291953 (ClinicalTrials.gob

  6. Addendum to the AAPM's TG-51 protocol for clinical reference dosimetry of high-energy photon beams

    International Nuclear Information System (INIS)

    An addendum to the AAPM's TG-51 protocol for the determination of absorbed dose to water in megavoltage photon beams is presented. This addendum continues the procedure laid out in TG-51 but new kQ data for photon beams, based on Monte Carlo simulations, are presented and recommendations are given to improve the accuracy and consistency of the protocol's implementation. The components of the uncertainty budget in determining absorbed dose to water at the reference point are introduced and the magnitude of each component discussed. Finally, the consistency of experimental determination of ND,w coefficients is discussed. It is expected that the implementation of this addendum will be straightforward, assuming that the user is already familiar with TG-51. The changes introduced by this report are generally minor, although new recommendations could result in procedural changes for individual users. It is expected that the effort on the medical physicist's part to implement this addendum will not be significant and could be done as part of the annual linac calibration

  7. Addendum to the AAPM's TG-51 protocol for clinical reference dosimetry of high-energy photon beams

    Energy Technology Data Exchange (ETDEWEB)

    McEwen, Malcolm, E-mail: malcolm.mcewen@nrc-cnrc.gc.ca [National Research Council, 1200 Montreal Road, Ottawa, Ontario (Canada); DeWerd, Larry [University of Wisconsin, 1111 Highland Avenue, Madison, Wisconsin 53705 (United States); Ibbott, Geoffrey [Department of Radiation Physics, M D Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, Texas 77030 (United States); Followill, David [IROC Houston QA Center, Radiological Physics Center, 8060 El Rio Street, Houston, Texas 77054 (United States); Rogers, David W. O. [Carleton Laboratory for Radiotherapy Physics, Physics Department, Carleton University, 1125 Colonel By Drive, Ottawa, Ontario (Canada); Seltzer, Stephen [National Institute of Standards and Technology, Gaithersburg, Maryland 20899 (United States); Seuntjens, Jan [Medical Physics Unit, McGill University, 1650 Cedar Avenue, Montreal, Québec (Canada)

    2014-04-15

    An addendum to the AAPM's TG-51 protocol for the determination of absorbed dose to water in megavoltage photon beams is presented. This addendum continues the procedure laid out in TG-51 but new k{sub Q} data for photon beams, based on Monte Carlo simulations, are presented and recommendations are given to improve the accuracy and consistency of the protocol's implementation. The components of the uncertainty budget in determining absorbed dose to water at the reference point are introduced and the magnitude of each component discussed. Finally, the consistency of experimental determination of N{sub D,w} coefficients is discussed. It is expected that the implementation of this addendum will be straightforward, assuming that the user is already familiar with TG-51. The changes introduced by this report are generally minor, although new recommendations could result in procedural changes for individual users. It is expected that the effort on the medical physicist's part to implement this addendum will not be significant and could be done as part of the annual linac calibration.

  8. Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer: the protocol of the KLASS-02 multicenter randomized controlled clinical trial

    International Nuclear Information System (INIS)

    Despite the well-described benefits of laparoscopic surgery such as lower operative blood loss and enhanced postoperative recovery in gastric cancer surgery, the application of laparoscopic surgery in patients with locally advanced gastric cancer (AGC) remains elusive owing to a lack of clinical evidence. Recently, the Korean Laparoscopic Surgical Society Group launched a new multicenter randomized clinical trial (RCT) to compare laparoscopic and open D2 lymphadenectomy for patients with locally AGC. Here, we introduce the protocol of this clinical trial. This trial is an investigator-initiated, randomized, controlled, parallel group, non-inferiority trial. Gastric cancer patients diagnosed with primary tumors that have invaded into the muscle propria and not into an adjacent organ (cT2–cT4a) in preoperative studies are recruited. Another criterion for recruitment is no lymph node metastasis or limited perigastric lymph node (including lymph nodes around the left gastric artery) metastasis. A total 1,050 patients in both groups are required to statistically show non-inferiority of the laparoscopic approach with respect to the primary end-point, relapse-free survival of 3 years. Secondary outcomes include postoperative morbidity and mortality, postoperative recovery, quality of life, and overall survival. Surgeons who are validated through peer-review of their surgery videos can participate in this clinical trial. This clinical trial was designed to maintain the principles of a surgical clinical trial with internal validity for participating surgeons. Through the KLASS-02 RCT, we hope to show the efficacy of laparoscopic D2 lymphadenectomy in AGC patients compared with the open procedure. ClinicalTrial.gov, https://www.clinicaltrials.gov/ct2/show/NCT01456598?term

  9. Nursing Students' Opinion on the Use of Smartphone Applications (Apps) in Clinical Education and Training: A Study Protocol.

    Science.gov (United States)

    O'Connor, Siobhan; Andrews, Tom

    2016-01-01

    Nurse educators are exploring different mobile technologies to provide additional support to nursing students in clinical practice. However, the view of nursing students on the use of smartphone applications (apps) to enhance clinical education has not been explored. This proposed study will use a self-reported questionnaire to examine the opinions of nursing students on the current and potential use of smartphone apps when training in clinical settings. Descriptive and inferential statistics will be performed on the quantitative data. Qualitative data from open ended questions will be thematically analysed using the framework approach. This will be the first study to examine the use of smartphone apps as a support in clinical teaching from a students' perspective. Their opinion is vital if the right mobile technology is to be designed and implemented. PMID:27332464

  10. Telephone follow-up by nurse following total knee arthroplasty - protocol for a randomized clinical trial (NCT01771315)

    DEFF Research Database (Denmark)

    Szöts, Kirsten; Konradsen, Hanne; Solgaard, Søren;

    2014-01-01

    to the orthopaedic outpatient clinic during the rehabilitation period. METHOD/DESIGN: The design is a randomized un-blinded parallel group clinical trial conducted at the Department of Orthopaedic Surgery, Gentofte Hospital, the Capital Region of Denmark. In total, 116 patients will be allocated by an external...... of life, general self-efficacy and the number of acute visits to the orthopaedic outpatient clinic. DISCUSSION: The result of this trial is expected to provide new knowledge to support the development of targeted and effective follow-up after total knee arthroplasty in order to improve the patients......´ health-related knowledge and skills of being able to take actively part in their illness and improve their health status. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01771315....

  11. Can a management pathway for chronic cough in children improve clinical outcomes: protocol for a multicentre evaluation

    Science.gov (United States)

    2010-01-01

    Background Chronic cough is common and is associated with significant economic and human costs. While cough can be a problematic symptom without serious consequences, it could also reflect a serious underlying illness. Evidence shows that the management of chronic cough in children needs to be improved. Our study tests the hypothesis that the management of chronic cough in children with an evidence-based management pathway is feasible and reliable, and improves clinical outcomes. Methods/Design We are conducting a multicentre randomised controlled trial based in respiratory clinics in 5 major Australian cities. Children (n = 250) fulfilling inclusion criteria (new patients with chronic cough) are randomised (allocation concealed) to the standardised clinical management pathway (specialist starts clinical pathway within 2 weeks) or usual care (existing care until review by specialist at 6 weeks). Cough diary, cough-specific quality of life (QOL) and generic QOL are collected at baseline and at 6, 10, 14, 26, and 52 weeks. Children are followed-up for 6 months after diagnosis and cough resolution (with at least monthly contact from study nurses). A random sample from each site will be independently examined to determine adherence to the pathway. Primary outcomes are group differences in QOL and proportion of children that are cough free at week 6. Discussion The clinical management pathway is based on data from Cochrane Reviews combined with collective clinical experience (250 doctor years). This study will provide additional evidence on the optimal management of chronic cough in children. Trial registration ACTRN12607000526471 PMID:21054884

  12. A clinical trial protocol for second line treatment of malignant brain tumors with BNCT at University of Tsukuba

    Energy Technology Data Exchange (ETDEWEB)

    Aiyama, H. [Department of Neurosurgery, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Nakai, K., E-mail: knakai@Neurosurg-tsukuba.com [Department of Neurosurgery, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Yamamoto, T. [Department of Neurosurgery, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan)] [Department of Radiation Oncology, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Nariai, T. [Department of Neurosurgery, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyouku (Japan); Kumada, H. [Department of Radiation Oncology, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Ishikawa, E. [Department of Neurosurgery, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Isobe, T. [Department of Radiation Oncology, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan); Endo, K.; Takada, T.; Yoshida, F.; Shibata, Y.; Matsumura, A. [Department of Neurosurgery, Graduate School of Comprehensive Human Science, University of Tsukuba, 1-1-1 Tennodai, Tsukuba (Japan)

    2011-12-15

    We have evaluated the efficacy and safety of boron neutron capture therapy (BNCT) for recurrent glioma and malignant brain tumor using a new protocol. One of the two patients enrolled in this trial is a man with recurrent glioblastoma and the other is a woman with anaplastic meningioma. Both are still alive and no severe adverse events have been observed. Our findings suggest that NCT will be safe as a palliative therapy for malignant brain tumors. - Highlights: Black-Right-Pointing-Pointer Boron neutron capture therapy (BNCT) for recurrent glioma and malignant brain tumor. Black-Right-Pointing-Pointer Two cases with recurrent glioblastoma and anaplastic meningioma. Black-Right-Pointing-Pointer No severe adverse events have been observed using BNCT. Black-Right-Pointing-Pointer BNCT has a possibility of a safe palliative therapy for malignant brain tumors.

  13. Comprehensive small animal imaging strategies on a clinical 3 T dedicated head MR-scanner; adapted methods and sequence protocols in CNS pathologies.

    Directory of Open Access Journals (Sweden)

    Deepu R Pillai

    Full Text Available BACKGROUND: Small animal models of human diseases are an indispensable aspect of pre-clinical research. Being dynamic, most pathologies demand extensive longitudinal monitoring to understand disease mechanisms, drug efficacy and side effects. These considerations often demand the concomitant development of monitoring systems with sufficient temporal and spatial resolution. METHODOLOGY AND RESULTS: This study attempts to configure and optimize a clinical 3 Tesla magnetic resonance scanner to facilitate imaging of small animal central nervous system pathologies. The hardware of the scanner was complemented by a custom-built, 4-channel phased array coil system. Extensive modification of standard sequence protocols was carried out based on tissue relaxometric calculations. Proton density differences between the gray and white matter of the rodent spinal cord along with transverse relaxation due to magnetic susceptibility differences at the cortex and striatum of both rats and mice demonstrated statistically significant differences. The employed parallel imaging reconstruction algorithms had distinct properties dependent on the sequence type and in the presence of the contrast agent. The attempt to morphologically phenotype a normal healthy rat brain in multiple planes delineated a number of anatomical regions, and all the clinically relevant sequels following acute cerebral ischemia could be adequately characterized. Changes in blood-brain-barrier permeability following ischemia-reperfusion were also apparent at a later time. Typical characteristics of intra-cerebral haemorrhage at acute and chronic stages were also visualized up to one month. Two models of rodent spinal cord injury were adequately characterized and closely mimicked the results of histological studies. In the employed rodent animal handling system a mouse model of glioblastoma was also studied with unequivocal results. CONCLUSIONS: The implemented customizations including extensive

  14. Can a management pathway for chronic cough in children improve clinical outcomes: protocol for a multicentre evaluation

    Directory of Open Access Journals (Sweden)

    Masters IB

    2010-11-01

    Full Text Available Abstract Background Chronic cough is common and is associated with significant economic and human costs. While cough can be a problematic symptom without serious consequences, it could also reflect a serious underlying illness. Evidence shows that the management of chronic cough in children needs to be improved. Our study tests the hypothesis that the management of chronic cough in children with an evidence-based management pathway is feasible and reliable, and improves clinical outcomes. Methods/Design We are conducting a multicentre randomised controlled trial based in respiratory clinics in 5 major Australian cities. Children (n = 250 fulfilling inclusion criteria (new patients with chronic cough are randomised (allocation concealed to the standardised clinical management pathway (specialist starts clinical pathway within 2 weeks or usual care (existing care until review by specialist at 6 weeks. Cough diary, cough-specific quality of life (QOL and generic QOL are collected at baseline and at 6, 10, 14, 26, and 52 weeks. Children are followed-up for 6 months after diagnosis and cough resolution (with at least monthly contact from study nurses. A random sample from each site will be independently examined to determine adherence to the pathway. Primary outcomes are group differences in QOL and proportion of children that are cough free at week 6. Discussion The clinical management pathway is based on data from Cochrane Reviews combined with collective clinical experience (250 doctor years. This study will provide additional evidence on the optimal management of chronic cough in children. Trial registration ACTRN12607000526471

  15. Study on the evaluation of the clinical effects of traditional chinese medicine in heart failure by complex intervention: protocol of SECETCM-HF

    Directory of Open Access Journals (Sweden)

    Jia Xiuli

    2009-12-01

    Full Text Available Abstract Background Experts in Traditional Chinese Medicine (TCM have studied the TCM subject of the pathogenesis of heart failure (HF for several decades. As a result, the general idea is ben deficiency and biao excess. However, the clinical evaluation system which combined the TCM and western medicine in HF has not been developed yet. The objective is to establish the evaluation index system for the integration of TCM and western medicine. The evaluation indexes which include TCM items will specify the research design and methods. Methods Nine medical centers in different cities in China will participate in the trial. A population of 340 patients with HF will be enrolled through a central randomized system for different test groups. Group A will be treated with only western medicine, while group B with western and Chinese medicine together. The study will last for 12 months from the date of enrollment. The cardiovascular death will be the primary outcome. Discussion By putting the protocol into practice, the clinical effects of TCM for HF will be identified scientifically, objectively as well as rationally. The proper index system which built in the study will be helpful for the clinical effect expression of HF by integrated medicine in future. Trial Registration ChiCTR-TRC-00000059

  16. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    Directory of Open Access Journals (Sweden)

    Krämer Jürgen

    2004-03-01

    Full Text Available Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. Discussion A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

  17. Brief intervention for alcohol misuse in people attending sexual health clinics: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sanatinia Rahil

    2012-08-01

    Full Text Available Abstract Background Over the last 30 years the number of people who drink alcohol at harmful levels has increased in many countries. There have also been large increases in rates of sexually transmitted infections. Available evidence suggests that excessive alcohol consumption and poor sexual health may be linked. The prevalence of harmful alcohol use is higher among people attending sexual health clinics than in the general population, and a third of those attending clinics state that alcohol use affects whether they have unprotected sex. Previous research has demonstrated that brief intervention for alcohol misuse in other medical settings can lead to behavioral change, but the clinical- and cost-effectiveness of this intervention on sexual behavior have not been examined. Methods We will conduct a two parallel-arm, randomized trial. A consecutive sample of people attending three sexual health clinics in London and willing to participate in the study will be screened for excessive alcohol consumption. Participants identified as drinking excessively will then be allocated to either active treatment (Brief Advice and referral for Brief Intervention or control treatment (a leaflet on healthy living. Randomization will be via an independent and remote telephone randomization service and will be stratified by study clinic. Brief Advice will comprise feedback on the possible health consequences of excessive alcohol consumption, written information about alcohol and the offer of an appointment for further assessment and Brief Intervention. Follow-up data on alcohol use, sexual behavior, health related quality of life and service use will be collected by a researcher masked to allocation status six months later. The primary outcome for the study is mean weekly alcohol consumption during the previous three months, and the main secondary outcome is the proportion of participants who report unprotected sex during this period. Discussion Opportunistic

  18. Impact of clinical registries on quality of patient care and health outcomes: protocol for a systematic review

    Science.gov (United States)

    Hoque, Dewan Md Emdadul; Kumari, Varuni; Ruseckaite, Rasa; Romero, Lorena; Evans, Sue M

    2016-01-01

    Introduction Many developed countries have regional and national clinical registries aimed at improving health outcomes of patients diagnosed with particular diseases or cared for in particular healthcare settings. Clinical quality registries (CQRs) are clinical registries established with the purpose of monitoring quality of care and providing feedback to improve health outcomes. The aim of this systematic review is to understand the impact of CQRs on (1) mortality/survival; (2) measures of outcome that reflect a process or outcome of healthcare; (3) healthcare utilisation and (4) costs. Methods and analysis The PRISMA-P methodology, checklist and standard strategy using predefined inclusion and exclusion criteria and structured data abstraction tools will be followed. A search of the electronic databases MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and CINAHL will be undertaken, in addition to Google Scholar and grey literature, to identify studies in English covering the period January 1980 to December 2014. Case–control, cohort, randomised controlled trials and controlled clinical trials which describe the registry as an intervention will be eligible for inclusion. Narrative synthesis of study findings will be conducted, guided by a conceptual framework developed to analyse the outcome measure of the registry using defined criteria. If sufficient studies are identified with a similar outcome of interest and measure using the same comparator and time of interval, results will be pooled for random-effects meta-analysis. Test for heterogeneity and sensitivity analysis will be conducted. To identify reporting bias, forest plots and funnel plots will be created and, if required, Egger's test will be conducted. Ethics and dissemination Ethical approval is not required as primary data will not be collected. Review results will be published as a part of thesis, peer-reviewed journal and conferences. Trial registration number CRD

  19. Measuring Life Events and Their Association With Clinical Disorder: A Protocol for Development of an Online Approach

    OpenAIRE

    Spence, Ruth; Bunn, Amanda; Nunn, Stephen; Hosang, Georgina; Kagan, Lisa; Fisher, Helen L.; Taylor, Matthew; Bifulco, Antonia

    2015-01-01

    Background: Severe life events are acknowledged as important aetiological factors in the development of clinical disorders, including major depression. Interview methods capable of assessing context and meaning of events have demonstrated superior validity compared to checklist questionnaire methods and arguments for interview approaches have resurfaced as choice of assessment tool has been implicated in gene-environment interactions in depression. Such approaches also have greater potential ...

  20. A simple MRI protocol in patients with clinically suspected appendicitis: results in 138 patients and effect on outcome of appendectomy

    Energy Technology Data Exchange (ETDEWEB)

    Cobben, Lodewijk [Medisch Centrum Haaglanden, Department of Radiology, Leidschendam (Netherlands); Groot, Ingrid [Medisch Centrum Haaglanden, Department of Surgery, Leidschendam (Netherlands); Kingma, Lucas; Coerkamp, Emile; Puylaert, Julien [Medisch Centrum Haaglanden, Department of Radiology, Den Haag (Netherlands); Blickman, Johan [Universitair Medisch Centrum St Radboud, Department of Radiology, Geert Grooteplein 10, GA, Nijmegen (Netherlands)

    2009-05-15

    To establish the value of breathhold magnetic resonance imaging (MRI) in the diagnosis of acute appendicitis. Over a 14-month period, 138 patients clinically suspected of having appendicitis were evaluated prospectively with MRI and comprised the study group. Fast turbo spin-echo breathhold T1, T2 and T2 fat suppression sequences were used in coronal and axial planes. The imaging results were recorded separately and subsequently correlated with clinical, radiological and histopathological follow-up. The effect of imaging strategies in patients suspected of appendicitis on hospital resources was calculated. Sixty-two of the 138 patients had a histopathologically proven appendicitis. MRI determined appendicitis in 63 patients, with one examination being false positive. The resulting sensitivity and specificity were 100% and 99%, respectively. MRI showed an alternative diagnosis in 41 of the 75 remaining patients. In 22 of the remaining 34 patients, a normal appendix was depicted with MRI. In two patients, where MRI showed no appendicitis, an alternative diagnosis or normal appendix, an unnecessary appendectomy was performed. The overall effect of using MRI in patients suspected of appendicitis on the use of hospital resources could have been a net saving between EUR 55,746 and EUR 72,534. MRI has a high accuracy in detecting and excluding appendicitis, an alternative diagnosis or showing the normal appendix, and can be a valuable and cost-effective tool in the workup of patients clinically suspected of having appendicitis. (orig.)

  1. A simple MRI protocol in patients with clinically suspected appendicitis: results in 138 patients and effect on outcome of appendectomy

    International Nuclear Information System (INIS)

    To establish the value of breathhold magnetic resonance imaging (MRI) in the diagnosis of acute appendicitis. Over a 14-month period, 138 patients clinically suspected of having appendicitis were evaluated prospectively with MRI and comprised the study group. Fast turbo spin-echo breathhold T1, T2 and T2 fat suppression sequences were used in coronal and axial planes. The imaging results were recorded separately and subsequently correlated with clinical, radiological and histopathological follow-up. The effect of imaging strategies in patients suspected of appendicitis on hospital resources was calculated. Sixty-two of the 138 patients had a histopathologically proven appendicitis. MRI determined appendicitis in 63 patients, with one examination being false positive. The resulting sensitivity and specificity were 100% and 99%, respectively. MRI showed an alternative diagnosis in 41 of the 75 remaining patients. In 22 of the remaining 34 patients, a normal appendix was depicted with MRI. In two patients, where MRI showed no appendicitis, an alternative diagnosis or normal appendix, an unnecessary appendectomy was performed. The overall effect of using MRI in patients suspected of appendicitis on the use of hospital resources could have been a net saving between EUR 55,746 and EUR 72,534. MRI has a high accuracy in detecting and excluding appendicitis, an alternative diagnosis or showing the normal appendix, and can be a valuable and cost-effective tool in the workup of patients clinically suspected of having appendicitis. (orig.)

  2. A protocol for a randomized clinical trial of interactive video dance: potential for effects on cognitive function

    Directory of Open Access Journals (Sweden)

    Jovancevic Jelena

    2012-06-01

    Full Text Available Abstract Background Physical exercise has the potential to affect cognitive function, but most evidence to date focuses on cognitive effects of fitness training. Cognitive exercise also may influence cognitive function, but many cognitive training paradigms have failed to provide carry-over to daily cognitive function. Video games provide a broader, more contextual approach to cognitive training that may induce cognitive gains and have carry over to daily function. Most video games do not involve physical exercise, but some novel forms of interactive video games combine physical activity and cognitive challenge. Methods/Design This paper describes a randomized clinical trial in 168 postmenopausal sedentary overweight women that compares an interactive video dance game with brisk walking and delayed entry controls. The primary endpoint is adherence to activity at six months. Additional endpoints include aspects of physical and mental health. We focus this report primarily on the rationale and plans for assessment of multiple cognitive functions. Discussion This randomized clinical trial may provide new information about the cognitive effects of interactive videodance. It is also the first trial to examine physical and cognitive effects in older women. Interactive video games may offer novel strategies to promote physical activity and health across the life span. The study is IRB approved and the number is: PRO08080012 ClinicalTrials.gov Identifier: NCT01443455

  3. Clinical Decision Making and Outcome in Routine Care for People with Severe Mental Illness (CEDAR: Study protocol

    Directory of Open Access Journals (Sweden)

    Nemes Zoltan

    2010-11-01

    Full Text Available Abstract Background A considerable amount of research has been conducted on clinical decision making (CDM in short-term physical conditions. However, there is a lack of knowledge on CDM and its outcome in long-term illnesses, especially in care for people with severe mental illness. Methods/Design The study entitled "Clinical decision making and outcome in routine care for people with severe mental illness" (CEDAR is carried out in six European countries (Denmark, Germany, Hungary, Italy, Switzerland and UK. First, CEDAR establishes a methodology to assess CDM in people with severe mental illness. Specific instruments are developed (and psychometric properties established to measure CDM style, key elements of CDM in routine care, as well as CDM involvement and satisfaction from patient and therapist perspectives. Second, these instruments are being put to use in a multi-national prospective observational study (bimonthly assessments during a one-year observation period; N = 560. This study investigates the immediate, short- and long-term effect of CDM on crucial dimensions of clinical outcome (symptom level, quality of life, needs by taking into account significant variables moderating the relationship between CDM and outcome. Discussion The results of this study will make possible to delineate quality indicators of CDM, as well as to specify prime areas for further improvement. Ingredients of best practice in CDM in the routine care for people with severe mental illness will be extracted and recommendations formulated. With its explicit focus on the patient role in CDM, CEDAR will also contribute to strengthening the service user perspective. This project will substantially add to improving the practice of CDM in mental health care across Europe. Trial register ISRCTN75841675.

  4. Hypnosis for hot flashes among postmenopausal women study: A study protocol of an ongoing randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Johnson Aimee K

    2011-10-01

    Full Text Available Abstract Background Hot flashes are a highly prevalent problem associated with menopause and breast cancer treatments. The recent findings from the Women's Health Initiative have important implications for the significance of a non-hormonal, mind-body intervention for hot flashes in breast cancer survivors. Women who take hormone therapy long-term may have a 1.2 to 2.0 fold increased risk of developing breast cancer. In addition, it is now known that hormone therapy with estrogen and progestin is associated with increased risk of cardiovascular disease and stroke. Currently there are limited options to hormone replacement therapy as non-hormonal pharmacological agents are associated with only modest activity and many adverse side effects. Because of this there is a need for more alternative, non-hormonal therapies. Hypnosis is a mind-body intervention that has been shown to reduce self-reported hot flashes by up to 68% among breast cancer survivors, however, the use of hypnosis for hot flashes among post-menopausal women has not been adequately explored and the efficacy of hypnosis in reducing physiologically measured hot flashes has not yet been determined. Methods/design A sample of 180 post-menopausal women will be randomly assigned to either a 5-session Hypnosis Intervention or 5-session structured-attention control with 12 week follow-up. The present study will compare hypnosis to a structured-attention control in reducing hot flashes (perceived and physiologically monitored in post-menopausal women in a randomized clinical trial. Outcomes will be hot flashes (self-report daily diaries; physiological monitoring; Hot Flash Related Daily Interference Scale, anxiety (State-Trait Anxiety Inventory; Hospital Anxiety and Depression Scale (HADS; anxiety visual analog scale (VAS rating; depression (Center for Epidemiologic Studies Depression Scale, sexual functioning (Sexual Activity Questionnaire, sleep quality (Pittsburgh Sleep Quality Index and

  5. Patterns in the recording of vital signs and early warning scores: compliance with a clinical escalation protocol

    OpenAIRE

    Hands, C.; Reid, E.; Meredith, Paul; Smith, G.; Prytherch, David; Schmidt, P.; Featherstone, P.

    2013-01-01

    Background. The recognition of patient deterioration depends largely on identifying abnormal vital signs, yet little is known about the daily pattern of vital signs measurement and charting. Methods. We compared the pattern of vital signs and VitalPAC Early Warning Score (ViEWS) data collected from admissions to all adult inpatient areas (except high care areas, such as critical care units) of a NHS district general hospital from 1 May 2010 to 30 April 2011, to the hospital’s clinical escalat...

  6. Acupuncture for lateral epicondylitis (tennis elbow): study protocol for a randomized, practitioner-assessor blinded, controlled pilot clinical trial

    Science.gov (United States)

    2013-01-01

    Background Lateral epicondylitis is the most frequent cause of pain around the elbow joint. It causes pain in the region of the elbow joint and results in dysfunction of the elbow and deterioration of the quality of life. The purpose of this study is to compare the effects of ipsilateral acupuncture, contralateral acupuncture and sham acupuncture on lateral epicondylitis. Methods/design Forty-five subjects with lateral epicondylitis will be randomized into three groups: the ipsilateral acupuncture group, contralateral acupuncture group and the sham acupuncture group. The inclusion criteria will be as follows: (1) age between 19 and 65 years with pain due to one-sided lateral epicondylitis that persisted for at least four weeks, (2) with tenderness on pressure limited to regions around the elbow joint, (3) complaining of pain during resistive extension of the middle finger or the wrist, (4) with average pain of NRS 4 or higher during the last one week at a screening visit and (5) voluntarily agree to this study and sign a written consent. Acupuncture treatment will be given 10 times in total for 4 weeks to all groups. Follow up observations will be conducted after the completion of the treatment, 8 weeks and 12 weeks after the random assignment. Ipsilateral acupuncture group and contralateral acupuncture group will receive acupuncture on LI4, TE5, LI10, LI11, LU5, LI12 and two Ashi points. The sham acupuncture group will receive treatment on acupuncture points not related to the lateral epicondylitis using a non-invasive method. The needles will be maintained for 20 minutes. The primary outcome will be differences in the visual analogue scale (VAS) for elbow pain between the groups. The secondary outcome will be differences in patient-rated tennis elbow evaluation (PRTEE), pain-free/maximum grip strength (Dynamometer), pressure pain threshold, clinically relevant improvement, patient global assessment, and the EQ-5D. The data will be analyzed with the paired t

  7. Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220

    Directory of Open Access Journals (Sweden)

    Jimenez Carmen

    2005-10-01

    ; as secondary variables, we will record the changes in diurnal pain intensity on a visual analogue scale (VAS, nocturnal pain intensity on the VAS, doses of non-steroid anti-inflammatory drugs (NSAIDs taken during the study period, credibility scale for the treatment, degree of improvement perceived by the patient and degree of improvement perceived by the evaluator. A follow up examination will be made at 3, 6 and 12 months after the study period has ended. Two types of population will be considered for analysis: per protocol and per intention to treat. Discussion The discussion will take into account the limitations of the study, together with considerations such as the choice of a simple, safe method to treat this shoulder complaint, the choice of the control group, and the blinding of the patients, evaluators and those responsible for carrying out the final analysis.

  8. Incorporation of expert variability into breast cancer treatment recommendation in designing clinical protocol guided fuzzy rule system models.

    Science.gov (United States)

    Garibaldi, Jonathan M; Zhou, Shang-Ming; Wang, Xiao-Ying; John, Robert I; Ellis, Ian O

    2012-06-01

    It has been often demonstrated that clinicians exhibit both inter-expert and intra-expert variability when making difficult decisions. In contrast, the vast majority of computerized models that aim to provide automated support for such decisions do not explicitly recognize or replicate this variability. Furthermore, the perfect consistency of computerized models is often presented as a de facto benefit. In this paper, we describe a novel approach to incorporate variability within a fuzzy inference system using non-stationary fuzzy sets in order to replicate human variability. We apply our approach to a decision problem concerning the recommendation of post-operative breast cancer treatment; specifically, whether or not to administer chemotherapy based on assessment of five clinical variables: NPI (the Nottingham Prognostic Index), estrogen receptor status, vascular invasion, age and lymph node status. In doing so, we explore whether such explicit modeling of variability provides any performance advantage over a more conventional fuzzy approach, when tested on a set of 1310 unselected cases collected over a fourteen year period at the Nottingham University Hospitals NHS Trust, UK. The experimental results show that the standard fuzzy inference system (that does not model variability) achieves overall agreement to clinical practice around 84.6% (95% CI: 84.1-84.9%), while the non-stationary fuzzy model can significantly increase performance to around 88.1% (95% CI: 88.0-88.2%), pdecision support systems in any application domain. PMID:22265814

  9. Impact of clinical leadership in teams’ course on quality, efficiency, responsiveness and trust in the emergency department: study protocol of a trailing research study

    Science.gov (United States)

    Husebø, Sissel Eikeland; Olsen, Øystein Evjen

    2016-01-01

    Introduction Clinical leadership has long been recognised as critical for optimising patient safety, quality of care and interprofessional teamwork in busy and stressful healthcare settings. There is a need to compensate for the absence of the conventional mentor-to-apprentice transfer of clinical leadership knowledge and skills. While young doctors and nurses are increasingly proficient in medical, surgical and technical skills, their training in, and knowledge of clinical leadership skills, is not adequate to meet the demands for these non-technical skills in the emergency department. Thus, the purpose of the paper is to present and discuss the study protocol of clinical leadership in a course for teams that aims to improve quality, efficiency, responsiveness of healthcare services and collegial trust in the emergency department. Methods and analysis The study employs a trailing research design using multiple quantitative and qualitative methods in the summative (pretest and post-test) and formative evaluation. Quantitative data have been collected from a patient questionnaire, the emergency departments’ database and by the observation of team performance. Qualitative data have been collected by shadowing healthcare professionals and through focus group interviews. To ensure trustworthiness in the data analysis, we will apply member checks and analyst triangulation, in addition to providing contextual and sample description to allow for evaluation of transferability of our results to other contexts and groups. Ethics and dissemination The study is approved by the ethics committee of the western part of Norway and the hospital. The study is based on voluntary participation and informed written consent. Informants can withdraw at any point in time. The results will be disseminated at research conferences, peer review journals and through public presentations to people outside the scientific community. PMID:27515758

  10. Correction of vitamin D deficiency in critically ill patients - VITdAL@ICU study protocol of a double-blind, placebo-controlled randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Amrein Karin

    2012-11-01

    Full Text Available Abstract Background Vitamin D deficiency is associated with multiple adverse health outcomes including increased morbidity and mortality in the general population and in critically ill patients. However, no randomized controlled trial has evaluated so far whether treatment with sufficiently large doses of vitamin D can improve clinical outcome of patients in an intensive care setting. Methods/design The VITdAL@ICU trial is an investigator-initiated, non-commercial, double-blind, placebo-controlled randomized clinical trial. This study compares high-dose oral cholecalciferol (vitamin D3 versus placebo treatment in a mixed population of 480 critically ill patients with low 25-hydroxyvitamin-D levels at study enrollment (≤ 20ng/ml. Following an initial loading dose of 540,000 IU of vitamin D3, patients receive 90,000 IU of vitamin D3 on a monthly basis for 5 months. The study is designed to compare clinical outcome in the two study arms with the primary endpoint being length of hospital stay. Secondary endpoints include among others length of ICU stay, the percentage of patients with 25(OHD levels > 30 ng/ml at day 7, ICU and hospital mortality and duration of mechanical ventilation. We describe here the VITdAL@ICU study protocol for the primary report. Discussion This trial is designed to evaluate whether high-dose vitamin D3 is able to improve morbidity and mortality in a mixed population of adult critically ill patients and correct vitamin D deficiency safely. Trial registration ClinicalTrials: NCT01130181

  11. Clinical Implementation of an Online Adaptive Plan-of-the-Day Protocol for Nonrigid Motion Management in Locally Advanced Cervical Cancer IMRT

    Energy Technology Data Exchange (ETDEWEB)

    Heijkoop, Sabrina T., E-mail: s.heijkoop@erasmusmc.nl; Langerak, Thomas R.; Quint, Sandra; Bondar, Luiza; Mens, Jan Willem M.; Heijmen, Ben J.M.; Hoogeman, Mischa S.

    2014-11-01

    Purpose: To evaluate the clinical implementation of an online adaptive plan-of-the-day protocol for nonrigid target motion management in locally advanced cervical cancer intensity modulated radiation therapy (IMRT). Methods and Materials: Each of the 64 patients had four markers implanted in the vaginal fornix to verify the position of the cervix during treatment. Full and empty bladder computed tomography (CT) scans were acquired prior to treatment to build a bladder volume-dependent cervix-uterus motion model for establishment of the plan library. In the first phase of clinical implementation, the library consisted of one IMRT plan based on a single model-predicted internal target volume (mpITV), covering the target for the whole pretreatment observed bladder volume range, and a 3D conformal radiation therapy (3DCRT) motion-robust backup plan based on the same mpITV. The planning target volume (PTV) combined the ITV and nodal clinical target volume (CTV), expanded with a 1-cm margin. In the second phase, for patients showing >2.5-cm bladder-induced cervix-uterus motion during planning, two IMRT plans were constructed, based on mpITVs for empty-to-half-full and half-full-to-full bladder. In both phases, a daily cone beam CT (CBCT) scan was acquired to first position the patient based on bony anatomy and nodal targets and then select the appropriate plan. Daily post-treatment CBCT was used to verify plan selection. Results: Twenty-four and 40 patients were included in the first and second phase, respectively. In the second phase, 11 patients had two IMRT plans. Overall, an IMRT plan was used in 82.4% of fractions. The main reasons for selecting the motion-robust backup plan were uterus outside the PTV (27.5%) and markers outside their margin (21.3%). In patients with two IMRT plans, the half-full-to-full bladder plan was selected on average in 45% of the first 12 fractions, which was reduced to 35% in the last treatment fractions. Conclusions: The implemented

  12. Three Years of a Nonsurgical Periodontal Treatment Protocol to Observe Clinical Outcomes in ≥ 6-mm Pockets: A Retrospective Case Series.

    Science.gov (United States)

    Roncati, Marisa; Gariffo, Annalisa

    2016-01-01

    A total of 25 patients were treated with a nonsurgical periodontal treatment protocol (NSPTP) consisting of four appointments (three within 1 week and one approximately 30 days later). Nonsurgical periodontal instrumentation was implemented, with the adjunctive use of thermal diode lasers (wavelength of 808 or 980 nm). The patients were scheduled for recall visits every 3 months and reevaluated 1 year post-NSPTP. They were subsequently monitored at 4-month intervals for the remaining 2-year follow-up maintenance period. In total, 698 teeth (210 multirooted and 488 single-rooted) were included in the study. The mean bleeding on probing was 43% at baseline and decreased to 12% at 12 months and to 8% at 3 years. The initial ≥ 6-mm probing pocket depth (PPD) in single-rooted teeth decreased from 6.2 mm at baseline to a mean of 1.8 mm at 12 months and remained at 1.8 mm at 3 years, with a mean clinical attachment level (CAL) gain of 4.4 mm. In multirooted teeth, the PPD decreased from 6.7 mm to a mean of 3.9 mm at 12 months and 3.6 mm at 3 years, with a mean CAL gain of 2.9 mm. The mean overall recession was 0.3 mm at baseline, 0.1 mm at 1 year, and 0.3 mm at the 3-year follow-up. In the short-term followup period, uniform and consistent implementation of the NSPTP used here with adjunctive use of thermal diode lasers seemed to convey therapeutic benefits, stable periodontal soft tissue levels, and satisfactory esthetics in patients with moderate to severe chronic periodontitis. The present protocol is relevant as a treatment option for medically compromised patients, those who refuse or delay surgical treatment, or those who present with other limitations. PMID:26901297

  13. Technetium-99m tetrofosmin rest/stress myocardial SPET with a same-day 2-hour protocol: comparison with coronary angiography. A Spanish-Portuguese multicentre clinical trial

    International Nuclear Information System (INIS)

    Technetium-99m tetrofosmin (Myoview) has unique properties for myocardial perfusion imaging very early after injection of the tracer. We used a very short same-day rest/stress protocol, to be performed within 2 h and evaluated its diagnostic accuracy. The study included 144 patients from seven Spanish and four Portuguese centres with a diagnosis of uncomplicated coronary artery disease (CAD); 78 patients (54%) had no history of prior myocardial infarction. Patients were injected with ≤300 MBq 99mTc-tetrofosmin at rest and ≤900 MBq approximately 1 h later at peak exercise. Single-photon emission tomographic (SPET) acquisitions were initiated within 5-30 min post injection. The results were compared with those of coronary angiography (CA). The data of 142 patients were completely evaluable (two with non-evaluable images were excluded). The quality of rest images was excellent or good in 86%, regionally problematic in 7%, poor but well interpretable in 5% and non-evaluable in 2%. The overall sensitivity for the detection of CAD was 93%, the specificity 38% and the accuracy 85%. The localization of defects by SPET in relation the perfusion territories of stenosed vessels (≥=50%) was achieved with a sensitivity of 64% for the left anterior descending artery, 49% for the left circumflex artery and 86% for the right coronary artery, and an accuracy of 71%, 72% and 73% respectively. Concordance of SPET and CA was 62% for single-vessel disease and 68% for multivessel disease. In conclusion, this Spanish-Portuguese multicentre clinical trial confirmed, in a considerable number of patients who underwent coronary angiography, the feasibility of 99mTc terofosmin (Myoview) rest/stress myocardial SPET using a very short protocol (2 h). (orig.)

  14. The PreCardio-study protocol – a randomized clinical trial of a multidisciplinary electronic cardiovascular prevention programme

    Directory of Open Access Journals (Sweden)

    Jacobs Nele

    2007-09-01

    medical and behavioural cardiovascular risk factors. An assessment of clinical, psychological and economical outcome measures will be performed. Trial registration ISRCTN23940498

  15. IMPLEmenting a clinical practice guideline for acute low back pain evidence-based manageMENT in general practice (IMPLEMENT: Cluster randomised controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Francis Jill

    2008-02-01

    Full Text Available Abstract Background Evidence generated from reliable research is not frequently implemented into clinical practice. Evidence-based clinical practice guidelines are a potential vehicle to achieve this. A recent systematic review of implementation strategies of guideline dissemination concluded that there was a lack of evidence regarding effective strategies to promote the uptake of guidelines. Recommendations from this review, and other studies, have suggested the use of interventions that are theoretically based because these may be more effective than those that are not. An evidence-based clinical practice guideline for the management of acute low back pain was recently developed in Australia. This provides an opportunity to develop and test a theory-based implementation intervention for a condition which is common, has a high burden, and for which there is an evidence-practice gap in the primary care setting. Aim This study aims to test the effectiveness of a theory-based intervention for implementing a clinical practice guideline for acute low back pain in general practice in Victoria, Australia. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of patients who are referred for a plain x-ray, and improving mean level of disability for patients three months post-consultation. Methods/Design This study protocol describes the details of a cluster randomised controlled trial. Ninety-two general practices (clusters, which include at least one consenting general practitioner, will be randomised to an intervention or control arm using restricted randomisation. Patients aged 18 years or older who visit a participating practitioner for acute non-specific low back pain of less than three months duration will be eligible for inclusion. An average of twenty-five patients per general practice will be recruited, providing a total of 2,300 patient participants. General practitioners in the

  16. Blood test ordering for unexplained complaints in general practice: the VAMPIRE randomised clinical trial protocol. [ISRCTN55755886

    Directory of Open Access Journals (Sweden)

    Bindels Patrick JE

    2006-03-01

    . Secondary outcome measures are the course of complaints, quality of life, satisfaction with care, anxiety of patients and practitioners, determinants of physicians' behaviour, health care utilisation and costs. Discussion The innovative aspect of this trial is that it combines a clinical-epidemiological study and a quality of care study.

  17. How to write a protocol: part 2.

    Science.gov (United States)

    Thomas, Kathy; Farrell, Mary Beth

    2015-03-01

    Clinical protocols play an important role in the provision of high-quality care in nuclear medicine. Properly written protocols help to ensure that nuclear medicine procedures are performed in a standardized, reproducible manner so that patients receive high-quality care. The following article is the second in a 2-part series on how to write a protocol. A framework for composing protocols and the components of clinical imaging protocols were detailed in the first article. This article details the framework and components of protocols for cardiac stress testing, therapy, and quality control. PMID:25655345

  18. Protocol for the BAG-RECALL clinical trial: a prospective, multi-center, randomized, controlled trial to determine whether a bispectral index-guided protocol is superior to an anesthesia gas-guided protocol in reducing intraoperative awareness with explicit recall in high risk surgical patients

    Directory of Open Access Journals (Sweden)

    Villafranca Alex

    2009-11-01

    Full Text Available Abstract Background Awareness with explicit recall of intra-operative events is a rare and distressing complication that may lead to severe psychological symptoms. Candidate depth of anesthesia monitors have been developed, partly with the aim of preventing this complication. Despite conflicting results from clinical trials and the lack of incisive validation, such monitors have enjoyed widespread clinical adoption, in particular the bispectral index. The American Society of Anesthesiologists has called for adequately powered and rigorously designed clinical trials to determine whether the use of such monitors decreases the incidence of awareness in various settings. The aim of this study is to determine with increased precision whether incorporating the bispectral index into a structured general anesthesia protocol decreases the incidence of awareness with explicit recall among a subset of surgical patients at increased risk for awareness and scheduled to receive an inhalation gas-based general anesthetic. Methods/Design BAG-RECALL is a multi-center, randomized, controlled clinical trial, in which 6,000 patients are being assigned to bispectral index-guided anesthesia (target range, 40 to 60 or end-tidal anesthetic gas-guided anesthesia (target range, 0.7 to 1.3 age-adjusted minimum alveolar concentration. Postoperatively, patients are being assessed for explicit recall at two intervals (0 to 72 hours, and 30 days after extubation. The primary outcome of the trial is awareness with explicit recall. Secondary outcomes include postoperative mortality, psychological symptoms, intensive care and hospital length of stay, average anesthetic gas administration, postoperative pain and nausea and vomiting, duration of stay in the recovery area, intra-operative dreaming, and postoperative delirium. Discussion This trial has been designed to complement two other clinical trials: B-Unaware and MACS (ClinicalTrials.gov numbers, NCT00281489 and NCT00689091

  19. A clinical study of metritis in dairy cows in the region of Batna (east of Algeria and their treatments using different therapeutic protocols

    Directory of Open Access Journals (Sweden)

    Mustapha Adnane Smadi

    2013-02-01

    Full Text Available Aim: The objective of this study was to make an inventory of cases of metritis in dairy cows during the post-partum period, to verify with a detailed clinical study on its real incidence in Batna region and to study the treatment of metritis, using different treatment protocols. Materials and Methods: A total of 432 dairy cows were examined during the post partum period and forty dairy cows having metritis were selected and assigned into four groups of 10 each to be treated with different drugs. Visits were programmed to track the status of uterine involution and different parameters of fecundity and fertility of cows. Result: The injection of Cloprostenol (a synthetic analogue of PGF2á has a significant effect particularly on shorter intervals from calving to the first mating, calving to positive fertilization and for the reduction of the number of services of inseminations. Similarly, the association "antibiotic+Flunixin /Meglumine has a positive effect on the parameters mentioned above . Conclusion: These results show that the double injection of Cloprostenol in the treatment of metritis improves the performance of fertility of animals and the dose of 3ml of PGF2á had succeeded in giving a positive effect on the different fertility parameters studied, compared to the dose of 2 ml. [Vet World 2013; 6(1.000: 45-48

  20. Nonbacterial osteitis. A clinical, histopathological, and imaging study with a proposal for protocol-based management of patients with this diagnosis

    International Nuclear Information System (INIS)

    Nonbacterial osteitis (NBO), a term referring to sterile bone lesions with nonspecific histopathological features of inflammation, may be either unifocal or multifocal, acute (≤6 months) or chronic, and recurrent. Only when the condition is chronic, recurrent, and multifocal is it appropriate to use the term chronic recurrent multifocal osteomyelitis (CRMO). We present our clinical experience as the largest reported series of children with NBO to date. We report a retrospective clinical, histopathological, and radiological study of 41 children with nonbacterial osteitis. Of 41 children (2-16 years of age) diagnosed with NBO in our institution over the last 6 years, 21 (51%) had recurrent disease and 18 (44%) had multifocal disease. The most common bones affected were the clavicle, femur, and tibia (in order of decreasing prevalence) accounting for 44 (63%) of a total of 70 lesions. Only one individual had synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome (synovitis, acne, pustulosis, hyperostosis, osteitis) and no other patients had evidence of bowel or skin disease. In the absence of evidence for an infective etiology, we recommend nonsteroidal anti-inflammatory agents as the first-line therapy and bisphosphonates only in cases of resistant disease. On the basis of our findings, we propose using a patient questionnaire and protocol for investigating and managing patients who present with NBO to orthopedic surgeons. We predict that this will benefit patients with this disorder by improving our knowledge of the presenting signs and symptoms and related disorders, rationalizing the therapeutic approach, and allowing us to learn about the natural history of the disease. (author)

  1. Does Interpersonal Psychotherapy improve clinical care for adolescents with depression attending a rural child and adolescent mental health service? Study protocol for a cluster randomised feasibility trial

    Directory of Open Access Journals (Sweden)

    Villanueva Elmer V

    2007-10-01

    -class correlation coefficient will be calculated and used to inform sample size calculations for subsequent large-scale trials. Qualitative data regarding process implementation will be collected quarterly from focus groups with participating clinicians over 18 months, plus phone interviews with participating adolescents and parent/guardians at 12 weeks and 24 weeks of treatment. The focus group qualitative data will be analysed using a Fourth Generation Evaluation methodology that includes a constant comparative cyclic analysis method. Discussion This study protocol will be informative for researchers and clinicians interested in considering, designing and/or conducting cluster randomised trials within community practice such as mental health services. Trial Registration Australian Clinical Trials Registry ACTRNO12607000324415

  2. Comparison of toxin removal outcomes in online hemodiafiltration and intra-dialytic exercise in high-flux hemodialysis: A prospective randomized open-label clinical study protocol

    Directory of Open Access Journals (Sweden)

    Maheshwari Vaibhav

    2012-11-01

    Full Text Available Abstract Background Maintenance hemodialysis (HD patients universally suffer from excess toxin load. Hemodiafiltration (HDF has shown its potential in better removal of small as well as large sized toxins, but its efficacy is restricted by inter-compartmental clearance. Intra-dialytic exercise on the other hand is also found to be effective for removal of toxins; the augmented removal is apparently obtained by better perfusion of skeletal muscles and decreased inter-compartmental resistance. The aim of this trial is to compare the toxin removal outcome associated with intra-dialytic exercise in HD and with post-dilution HDF. Methods/design The main hypothesis of this study is that intra-dialytic exercise enhances toxin removal by decreasing the inter-compartmental resistance, a major impediment for toxin removal. To compare the HDF and HD with exercise, the toxin rebound for urea, creatinine, phosphate, and β2-microglobulin will be calculated after 2 hours of dialysis. Spent dialysate will also be collected to calculate the removed toxin mass. To quantify the decrease in inter-compartmental resistance, the recently developed regional blood flow model will be employed. The study will be single center, randomized, self-control, open-label prospective clinical research where 15 study subjects will undergo three dialysis protocols (a high flux HD, (b post-dilution HDF, (c high flux HD with exercise. Multiple blood samples during each study session will be collected to estimate the unknown model parameters. Discussion This will be the first study to investigate the exercise induced physiological change(s responsible for enhanced toxin removal, and compare the toxin removal outcome both for small and middle sized toxins in HD with exercise and HDF. Successful completion of this clinical research will give important insights into exercise effect on factors responsible for enhanced toxin removal. The knowledge will give confidence for implementing

  3. Cryptographic Protocols:

    DEFF Research Database (Denmark)

    Geisler, Martin Joakim Bittel

    in Chapter 2. Comparisons play a key role in many systems such as online auctions and benchmarks — it is not unreasonable to say that when parties come together for a multiparty computation, it is because they want to make decisions that depend on private information. Decisions depend on comparisons....... We have implemented the comparison protocol in Java and benchmarks show that is it highly competitive and practical. The biggest contribution of this dissertation is a general framework for secure multiparty computation. Instead of making new ad hoc implementations for each protocol, we want a single......; benchmarks show that the approach is practical....

  4. A practice-based trial of blood pressure control in African Americans (TLC-Clinic: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Schoenthaler Antoinette

    2011-12-01

    Full Text Available Abstract Background Poorly controlled hypertension (HTN remains one of the most significant public health problems in the United States, in terms of morbidity, mortality, and economic burden. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC for blood pressure (BP reduction, the effectiveness of these approaches in primary care practices remains untested, especially among African Americans, who share a disproportionately greater burden of HTN-related outcomes. Methods/Design This randomized controlled trial tests the effectiveness of a practice-based comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC versus Usual Care (UC in 200 low-income, African Americans with uncontrolled hypertension. MINT-TLC is designed to help patients make appropriate lifestyle changes and develop skills to maintain these changes long-term. Patients in the MINT-TLC group attend 10 weekly group classes focused on healthy lifestyle changes (intensive phase; followed by 3 monthly individual motivational interviewing (MINT sessions (maintenance phase. The intervention is delivered by trained research personnel with appropriate treatment fidelity procedures. Patients in the UC condition receive a single individual counseling session on healthy lifestyle changes and print versions of the intervention materials. The primary outcome is within-patient change in both systolic and diastolic BP from baseline to 6 months. In addition to BP control at 6 months, other secondary outcomes include changes in the following lifestyle behaviors from baseline to 6 months: a physical activity, b weight loss, c number of daily servings of fruits and vegetables and d 24-hour urinary sodium excretion. Discussion This vanguard trial will provide information on how to refine MINT-TLC and integrate it into a standard treatment protocol for hypertensive African Americans

  5. Clinical efficacy and prognostic indicators for lower limb pedalling exercise early after stroke: Study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Myint Phyo

    2011-03-01

    Full Text Available Abstract Background It is known that repetitive, skilled, functional movement is beneficial in driving functional reorganisation of the brain early after stroke. This study will investigate a whether pedalling an upright, static exercise cycle, to provide such beneficial activity, will enhance recovery and b which stroke survivors might be able to participate in pedalling. Methods/Design Participants (n = 24 will be up to 30 days since stroke onset, with unilateral weakness and unable to walk without assistance. This study will use a modified exercise bicycle fitted with a UniCam crank. All participants will give informed consent, then undergo baseline measurements, and then attempt to pedal. Those able to pedal will be entered into a single-centre, observer-blinded randomised controlled trial (RCT. All participants will receive routine rehabilitation. The experimental group will, in addition, pedal daily for up to ten minutes, for up to ten working days. Prognostic indicators, measured at baseline, will be: site of stroke lesion, trunk control, ability to ambulate, and severity of lower limb paresis. The primary outcome for the RCT is ability to voluntarily contract paretic lower limb muscle, measured by the Motricity Index. Secondary outcomes include ability to ambulate and timing of onset and offset of activity in antagonist muscle groups during pedalling, measured by EMG. Discussion This protocol is for a trial of a novel therapy intervention. Findings will establish whether there is sufficient evidence of benefit to justify proceeding with further research into clinical efficacy of upright pedalling exercise early after stroke. Information on potential prognostic indicators will suggest which stroke survivors could benefit from the intervention. Trial Registration ISRCTN: ISRCTN45392701

  6. How to write a protocol: part 1.

    Science.gov (United States)

    Thomas, Kathy; Farrell, Mary Beth

    2015-03-01

    Clinical imaging protocols play an important role in the provision of high-quality care in nuclear medicine. It is imperative that all nuclear medicine facilities have protocols for every procedure performed. However, creating protocols that are detailed, unambiguous, and consistent is often easier said than done. Properly written protocols help to ensure that nuclear medicine procedures are performed in a standardized, reproducible manner so that patients receive high-quality care. This 2-part article provides technologists with a framework for composing comprehensive protocols. Part 1 discusses the secrets to successfully composing protocols ensuring they are detailed and step-by-step along with the importance of basing protocols on evidence from published guidelines and peer-reviewed literature. The components and important aspects of clinical imaging protocols are detailed. PMID:25613336

  7. The Resin-Embedded Cornea Prepared Via Rapid Processing Protocol : A Good Histomorphometric Target for Clinical Investigation in Ophthalmology and Optometry

    OpenAIRE

    Cheah, Pike See; Mohidin, Norhani; Mohd Ali, Bariah; Maung, Myint; Latif, Azian Abdul

    2008-01-01

    This study illustrates and quantifies the changes on corneal tissue between the paraffin-embedded and resin-embedded blocks and thus, selects a better target in investigational ophthalmology and optometry via light microscopy. Corneas of two cynomolgus monkeys (Macaca fascicularis) were used in this study. The formalin-fixed cornea was prepared in paraffin block via the conventional tissue processing protocol (4-day protocol) and stained with haematoxylin and eosin. The glutaraldehyde-fixed c...

  8. Rational Protocols

    Science.gov (United States)

    Cachin, Christian

    Security research continues to provide a plethora of new protocols and mechanisms; these solutions patch either existing vulnerabilities found in practical systems or solve hypothetical security problems in the sense that the problem is often conceived at the same time when the first solution is proposed. Yet only a very small fraction of this research is relevant to ordinary users in the sense that they are willing to actually deploy the technology.

  9. Gated SPECT evaluation of left ventricular function using a CZT camera and a fast low-dose clinical protocol: comparison to cardiac magnetic resonance imaging

    International Nuclear Information System (INIS)

    CZT technology allows ultrafast low-dose myocardial scintigraphy but its accuracy in assessing left ventricular function is still to be defined. The study group comprised 55 patients (23 women, mean age 63 ± 9 years) referred for myocardial perfusion scintigraphy. The patients were studied at rest using a CZT camera (Discovery NM530c; GE Healthcare) and a low-dose 99mTc-tetrofosmin clinical protocol (mean dose 264 ± 38 MBq). Gated SPECT imaging was performed as a 6-min list-mode acquisition, 15 min after radiotracer injection. Images were reformatted (8-frame to 16-frame) using Lister software on a Xeleris workstation (GE Healthcare) and then reconstructed with a dedicated iterative algorithm. Analysis was performed using Quantitative Gated SPECT (QGS) software. Within 2 weeks patients underwent cardiac magnetic resonance imaging (cMRI, 1.5-T unit CVi; GE Healthcare) using a 30-frame acquisition protocol and dedicated software for analysis (MASS 6.1; Medis). The ventricular volumes obtained with 8-frame QGS showed excellent correlations with the cMRI volumes (end-diastolic volume (EDV), r = 0.90; end-systolic volume (ESV), r = 0.94; p < 0.001). However, QGS significantly underestimated the ventricular volumes (mean differences: EDV, -39.5 ± 29 mL; ESV, -15.4 ± 22 mL; p < 0.001). Similarly, the ventricular volumes obtained with 16-frame QGS showed an excellent correlations with the cMRI volumes (EDV, r = 0.92; ESV, r = 0.95; p < 0.001) but with significant underestimations (mean differences: EDV, -33.2 ± 26 mL; ESV, -17.9 ± 20 mL; p < 0.001). Despite significantly lower values (47.9 ± 16 % vs. 51.2 ± 15 %, p < 0.008), 8-frame QGS mean ejection fraction (EF) was closely correlated with the cMRI values (r = 0.84, p < 0.001). The mean EF with 16-frame QGS showed the best correlation with the cMRI values (r = 0.91, p < 0.001) and was similar to the mean cMRI value (49.6 ± 16 %, p not significant). Regional analysis showed a good correlation between both 8-frame

  10. Gated SPECT evaluation of left ventricular function using a CZT camera and a fast low-dose clinical protocol: comparison to cardiac magnetic resonance imaging

    Energy Technology Data Exchange (ETDEWEB)

    Giorgetti, Assuero; Masci, Pier Giorgio; Marras, Gavino; Gimelli, Alessia; Genovesi, Dario; Lombardi, Massimo [Fondazione CNR/Regione Toscana ' ' G. Monasterio' ' , Pisa (Italy); Rustamova, Yasmine K. [Azerbaijan Medical University, Department of internal medicine Central Customs Hospital, Baku (Azerbaijan); Marzullo, Paolo [Istituto di Fisiologia Clinica del CNR, Pisa (Italy)

    2013-12-15

    CZT technology allows ultrafast low-dose myocardial scintigraphy but its accuracy in assessing left ventricular function is still to be defined. The study group comprised 55 patients (23 women, mean age 63 {+-} 9 years) referred for myocardial perfusion scintigraphy. The patients were studied at rest using a CZT camera (Discovery NM530c; GE Healthcare) and a low-dose {sup 99m}Tc-tetrofosmin clinical protocol (mean dose 264 {+-} 38 MBq). Gated SPECT imaging was performed as a 6-min list-mode acquisition, 15 min after radiotracer injection. Images were reformatted (8-frame to 16-frame) using Lister software on a Xeleris workstation (GE Healthcare) and then reconstructed with a dedicated iterative algorithm. Analysis was performed using Quantitative Gated SPECT (QGS) software. Within 2 weeks patients underwent cardiac magnetic resonance imaging (cMRI, 1.5-T unit CVi; GE Healthcare) using a 30-frame acquisition protocol and dedicated software for analysis (MASS 6.1; Medis). The ventricular volumes obtained with 8-frame QGS showed excellent correlations with the cMRI volumes (end-diastolic volume (EDV), r = 0.90; end-systolic volume (ESV), r = 0.94; p < 0.001). However, QGS significantly underestimated the ventricular volumes (mean differences: EDV, -39.5 {+-} 29 mL; ESV, -15.4 {+-} 22 mL; p < 0.001). Similarly, the ventricular volumes obtained with 16-frame QGS showed an excellent correlations with the cMRI volumes (EDV, r = 0.92; ESV, r = 0.95; p < 0.001) but with significant underestimations (mean differences: EDV, -33.2 {+-} 26 mL; ESV, -17.9 {+-} 20 mL; p < 0.001). Despite significantly lower values (47.9 {+-} 16 % vs. 51.2 {+-} 15 %, p < 0.008), 8-frame QGS mean ejection fraction (EF) was closely correlated with the cMRI values (r = 0.84, p < 0.001). The mean EF with 16-frame QGS showed the best correlation with the cMRI values (r = 0.91, p < 0.001) and was similar to the mean cMRI value (49.6 {+-} 16 %, p not significant). Regional analysis showed a good

  11. Observation and execution of upper-limb movements as a tool for rehabilitation of motor deficits in paretic stroke patients: protocol of a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Ertelt Denis

    2012-06-01

    Full Text Available Abstract Background Evidence exist that motor observation activates the same cortical motor areas that are involved in the performance of the observed actions. The so called “mirror neuron system” has been proposed to be responsible for this phenomenon. We employ this neural system and its capability to re-enact stored motor representations as a tool for rehabilitating motor control. In our new neurorehabilitative schema (videotherapy we combine observation of daily actions with concomitant physical training of the observed actions focusing on the upper limbs. Following a pilot study in chronic patients in an ambulatory setting, we currently designed a new multicenter clinical study dedicated to patients in the sub-acute state after stroke using a home-based self-induced training. Within our protocol we assess 1 the capability of action observation to elicit rehabilitational effects in the motor system, and 2 the capacity of this schema to be performed by patients without assistance from a physiotherapist. The results of this study would be of high health and economical relevance. Methods/design A controlled, randomized, multicenter, paralleled, 6 month follow-up study will be conducted on three groups of patients: one group will be given the experimental treatment whereas the other two will participate in control treatments. All patients will undergo their usual rehabilitative treatment beside participation in the study. The experimental condition consists in the observation and immediate imitation of common daily hand and arm actions. The two parallel control groups are a placebo group and a group receiving usual rehabilitation without any trial-related treatment. Trial randomization is provided via external data management. The primary efficacy endpoint is the improvement of the experimental group in a standardized motor function test (Wolf Motor Function Test relative to control groups. Further assessments refer to subjective and

  12. Histology protocols

    Directory of Open Access Journals (Sweden)

    CarloAlberto Redi

    2010-06-01

    Full Text Available Tim D. Hewitson & Ian A. Darby (Eds Humana press, Totowa, New Jersey (USA Series: Springer Protocols Methods in Molecular Biology, Volume 611, 2010 Pages: 230; € 83.15 ISBN: 978-1-60327-344-2 Impressive as it can sounds in the era that Biology see a clear dominance of reductionism with the idea that complexity can be disentagled more and more thanks to the use of molecular tools, the reader will remain fascinated by this slim and agile volume devoted to bring together what apparently are two separeted words: molecular biology and histology. Simply remembering to the youngest scientists.....

  13. SU-E-I-57: Evaluation and Optimization of Effective-Dose Using Different Beam-Hardening Filters in Clinical Pediatric Shunt CT Protocol

    International Nuclear Information System (INIS)

    Purpose: Study image optimization and radiation dose reduction in pediatric shunt CT scanning protocol through the use of different beam-hardening filters Methods: A 64-slice CT scanner at OU Childrens Hospital has been used to evaluate CT image contrast-to-noise ratio (CNR) and measure effective-doses based on the concept of CT dose index (CTDIvol) using the pediatric head shunt scanning protocol. The routine axial pediatric head shunt scanning protocol that has been optimized for the intrinsic x-ray tube filter has been used to evaluate CNR by acquiring images using the ACR approved CT-phantom and radiation dose CTphantom, which was used to measure CTDIvol. These results were set as reference points to study and evaluate the effects of adding different filtering materials (i.e. Tungsten, Tantalum, Titanium, Nickel and Copper filters) to the existing filter on image quality and radiation dose. To ensure optimal image quality, the scanner routine air calibration was run for each added filter. The image CNR was evaluated for different kVps and wide range of mAs values using above mentioned beam-hardening filters. These scanning protocols were run under axial as well as under helical techniques. The CTDIvol and the effective-dose were measured and calculated for all scanning protocols and added filtration, including the intrinsic x-ray tube filter. Results: Beam-hardening filter shapes energy spectrum, which reduces the dose by 27%. No noticeable changes in image low contrast detectability Conclusion: Effective-dose is very much dependent on the CTDIVol, which is further very much dependent on beam-hardening filters. Substantial reduction in effective-dose is realized using beam-hardening filters as compare to the intrinsic filter. This phantom study showed that significant radiation dose reduction could be achieved in CT pediatric shunt scanning protocols without compromising in diagnostic value of image quality

  14. SNOMED CT® Encoded Cancer Protocols

    OpenAIRE

    van Berkum, Monique M.

    2003-01-01

    SNOMED Clinical Terms® (SNOMED CT®) is being used to encode the Cancer Protocols published by the College of American Pathologists (CAP). As of January 1, 2004, one of the standards set for approved cancer programs by the American College of Surgeons Commission on Cancer will be that at least 90% of surgical pathology reports contain all essential data elements identified in the CAP Cancer Protocols.

  15. Proposta de protocolo de avaliação clínica da função mastigatória Proposal for mastication clinical evaluation protocol

    Directory of Open Access Journals (Sweden)

    Melina Evangelista Whitaker

    2009-01-01

    Full Text Available Objetivo: elaborar um protocolo de avaliação clínica da função mastigatória, visando auxiliar o fonoaudiólogo a identificar e interpretar os sinais clínicos de alterações na dinâmica da mastigação, além de possibilitar comparações de acompanhamento de tratamento e entre diferentes avaliadores. MÉTODOS: este protocolo foi elaborado com base na prática clínica de fonoaudiólogos que responderam a um questionário enviado por e-mail; na literatura, segundo a identificação dos pontos comuns a todos os protocolos de avaliação da mastigação; além da experiência dos fonoaudiólogos do Hospital de Reabilitação de Anomalias Craniofaciais da Universidade de São Paulo. RESULTADOS: o protocolo de avaliação clínica da mastigação contempla aspectos relacionados aos aspectos morfológicos e à neurofisiologia da função mastigatória: CONCLUSÃO: este trabalho contribui com a Fonoaudiologia, uma vez que busca, de maneira mais completa possível, critérios para a avaliação da mastigação, norteando a atuação fonoaudiológica clínica baseada em evidências.PURPOSE: to elaborate a protocol for the clinical evaluation of the masticatory function, aiming at aiding the speech pathologist to identify and interpret the clinical signals of the masticatory disorders, in its dynamics, in addition to allowing for inter-judge comparison and treatment continuation. METHODS: this protocol was elaborated based on the clinical practice of the speech pathologists that answered to a questionnaire sent by email; in the literature, according to the identification of the common points to all chewing evaluation protocols; in addition to the experience of the speech pathologists of HRAC/USP. RESULTS: the protocol for the clinical chewing evaluation considers aspects related to morphologic aspects and neurophysiology of the masticatory function. Conclusion: this study contributes to Speech Pathology, once that it searches, in the most

  16. IMPACT OF PHYSIOTHERAPIST-DESIGNED SUPERVISED EXERCISE PROTOCOL ON MUSCLE STRENGTH, AND AUTONOMIC PARAMETERS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS: A CLINICAL TRIAL

    OpenAIRE

    Renu B. Pattanshetty; Santosh P. Dobhal

    2015-01-01

    Background and Objectives: Type 2 diabetes mellitus is a heterogeneous group of disorders characterized by variable degree of insulin resistance, impaired insulin secretion, and increased glucose production. Physical activity is central to the management type 2 diabetes. There is less evidence to suggest the efficacy of combined effect of physiotherapist- designed supervised exercise protocol on muscle strength and autonomic parameters in such subjects. Hence, the present study was designed ...

  17. Neck-specific training with a cognitive behavioural approach compared with prescribed physical activity in patients with cervical radiculopathy : a protocol of a prospective randomised clinical trial

    OpenAIRE

    Dedering, Åsa; Halvorsen, Marie; Cleland, Joshua; Svensson, Mikael; Peolsson, Anneli

    2014-01-01

    Background Patients with cervical radiculopathy often have neck- and arm pain, neurological changes, activity limitations and difficulties in returning to work. Most patients are not candidates for surgery but are often treated with different conservative approaches and may be sick-listed for long periods. The purpose of the current study is to compare the effectiveness of neck-specific training versus prescribed physical activity. Methods/Design The current protocol is a two armed interventi...

  18. Clinical trials of CCLSG L874 and I874 protocols without cranial irradiation for standard-risk acute lymphoblastic leukemia in childhood

    International Nuclear Information System (INIS)

    In the CCLSG-874 protocol for children with low-risk (LR) and intermediate-risk (IR) acute lymphoblastic leukemia (ALL), two regimens with or without cranial irradiation (CI) were compared with respect to their ability to prevent central nervous system (CNS) leukemia and to improve overall outcome of ALL. From 1987 to 1990, 82 and 109 evaluable patients were registered into L874 and I874 protocols for LR and IR patients, respectively. All responders to induction therapy were randomized to treatment with 18 Gy of CI plus intrathecal methotrexate (MTX it) or to treatment with high-dose MTX plus MTX it. Patients were then treated with standard maintenance regimens of L874 and I874. At a median follow-up of 39 months (range 14-58 months) there was no difference in the rate of hematologic relapse between the CI group and MTX group. The rate of CNS relapse in the MTX group seemed to be higher (3 of 39 in L874 and 2 of 54 in I874) than that in the CI group (1 of 43 in L874 and 0 of 55 in I874), but these data were not statistically significant. The rates of 4-year event-free survival (EFS) in L874 were 81.1±7.6% (mean±SE) and 75.2±7.9% (ns) for the CI and MTX group, respectively, and the rates of EFS in I874 were 70.0±13.6% and 70.0±9.0% (ns) for the CI and MTX group, respectively. These data suggest that MTX alone may be as effective as CI to prolong disease-free survival in LR and IR ALL although further continuous studies are needed. Analysis of serial CCLSG protocols for ALL from 1981 revealed that the rate of EFS of ALL allover including all risk groups has gradually been increasing from 44.2±3.6% for 811 protocol and 53.1±3.5% for 841 to 65.5±3.6% for the present 874 protocol. (author)

  19. Dysphonia risk screening protocol

    Directory of Open Access Journals (Sweden)

    Katia Nemr

    2016-03-01

    Full Text Available OBJECTIVE: To propose and test the applicability of a dysphonia risk screening protocol with score calculation in individuals with and without dysphonia. METHOD: This descriptive cross-sectional study included 365 individuals (41 children, 142 adult women, 91 adult men and 91 seniors divided into a dysphonic group and a non-dysphonic group. The protocol consisted of 18 questions and a score was calculated using a 10-cm visual analog scale. The measured value on the visual analog scale was added to the overall score, along with other partial scores. Speech samples allowed for analysis/assessment of the overall degree of vocal deviation and initial definition of the respective groups and after six months, the separation of the groups was confirmed using an acoustic analysis. RESULTS: The mean total scores were different between the groups in all samples. Values ranged between 37.0 and 57.85 in the dysphonic group and between 12.95 and 19.28 in the non-dysphonic group, with overall means of 46.09 and 15.55, respectively. High sensitivity and specificity were demonstrated when discriminating between the groups with the following cut-off points: 22.50 (children, 29.25 (adult women, 22.75 (adult men, and 27.10 (seniors. CONCLUSION: The protocol demonstrated high sensitivity and specificity in differentiating groups of individuals with and without dysphonia in different sample groups and is thus an effective instrument for use in voice clinics.

  20. Teaching evidence based medicine literature searching skills to medical students during the clinical years - a protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Misso Marie

    2011-07-01

    Full Text Available Abstract Background Two of the key steps in evidence based medicine (EBM are being able to construct a clinical question and effectively search the literature to source relevant information. No evidence currently exists that informs whether such skills should be taught to medical students during their pre-clinical years, or delivered to include both the pre-clinical and clinical years of study. This is an important component of curriculum design as the level of clinical maturity of students can affect their perception of the importance and uptake of EBM principles in practice. Methods/Design A randomised controlled trial will be conducted to identify the effectiveness of delivering a formal workshop in EBM literature searching skills to third year medical students entering their clinical years of study. The primary outcome of EBM competency in literature searching skills will be evaluated using the Fresno tool. Discussion This trial will provide novel information on the effectiveness of delivering a formal education workshop in evidence based medicine literature searching skills during the clinical years of study. The result of this study will also identify the impact of teaching EBM literature searching skills to medical students during the clinical years of study.

  1. Clinical and Radiographic Mid-Term Outcomes After Total Shoulder Replacement: A Retrospective Study Protocol Including 400 Anatomical and Reverse Prosthetic Implants

    Science.gov (United States)

    Merolla, Giovanni; Tartarone, Antonio; Porcellini, Giuseppe

    2016-01-01

    Objectives: To obtain outcomes data on anatomical and reverse total shoulder arthroplasty by analysis of clinical scores and standard radiographs. Subject selection and enrollment: 400 consecutive series of patients replaced with anatomical and reverse total shoulder arthroplasty (minimum 3 years follow-up). Study Design: retrospective monocenter. Preoperative assessment: Demographics, clinical scores (Constant-Murley) as available, shoulder X-ray (AP, outlet and axillary views) . Last follow-up: Postoperative radiographhs and clinical scores. Adverse events and complications to be reported as occurred since implantation. Statistical analysis: Data collected will be summarized and analyzed for statistical significance. PMID:27326389

  2. Implementation of a guideline-based clinical pathway of care to improve health outcomes following whiplash injury (Whiplash ImPaCT: protocol of a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Trudy Rebbeck

    2016-04-01

    Discussion: This research is significant as it will be the first study to address the heterogeneity of whiplash by implementing a clinical pathway of care that matches evidence-based interventions to projected risk of poor recovery. The results of this trial have the potential to change clinical practice for WAD, thereby maximising treatment effects, improving patient outcomes, reducing costs and maintaining the compulsory third party system.

  3. Transfer of manualized CBT for social phobia into clinical practice (SOPHO-PRAX): a study protocol for a cluster-randomized controlled trial

    OpenAIRE

    Crawcour Stephen; Leibing Eric; Ginzburg Denise; Stangier Ulrich; Wiltink Jörg; Hoyer Jürgen

    2012-01-01

    Abstract Background Cognitive-behavioral therapy (CBT) is generally known to be efficacious in the treatment of social phobia when applied in RCTs, namely when the treatment manual is based on the Clark-Wells approach. However, little is known about the efficacy of manualized treatments in routine clinical practice (Phase IV of psychotherapy research). The present study (SOPHO-PRAX) is a continuation of a large multicenter randomized clinical trial (SOPHO-NET) and analyzes the extent to which...

  4. Feedback versus no feedback in improving patient outcome in group psychotherapy for eating disorders (F-EAT): protocol for a randomized clinical trial

    OpenAIRE

    Davidsen, Annika Helgadóttir; Poulsen, Stig; Waaddegaard, Mette; Lindschou, Jane; Lau, Marianne

    2014-01-01

    Background Continuous feedback on patient improvement and the therapeutic alliance may reduce the number of dropouts and increase patient outcome. There are, however, only three published randomized trials on the effect of feedback on the treatment of eating disorders, showing inconclusive results, and there are no randomized trials on the effect of feedback in group therapy. Accordingly the current randomized clinical trial, initiated in September 2012 at the outpatient clinic for eating dis...

  5. Quality assessment in in vivo NMR spectroscopy: IV. A multicentre trial of test objects and protocols for performance assessment in clinical NMR spectroscopy

    DEFF Research Database (Denmark)

    Keevil, S.F.; Barbiroli, B; Collins, D.J.;

    1995-01-01

    A multicentre trial of test objects and protocols for performance assessment in single volume and slice selective magnetic resonance spectroscopy (MRS) was conducted by the European Community Concerted Action on MRI and MRS. The trial assessed phosphorus and proton localisation techniques...... development of the Concerted Action's final recommendations for MRS performance assessment, and demonstrate that such assessment provides valuable information in the comparison of spectroscopy data from different sites and in the development of new localisation sequences, and provides a means of quality...... implemented on commercially available MR systems at ten sites in Europe. At each site, a number of parameters devised by the Concerted Action were measured using prototype test objects. Some of these parameters related to the quality of localisation and others to the overall performance of the spectrometer...

  6. The clinical assessment study of the foot (CASF: study protocol for a prospective observational study of foot pain and foot osteoarthritis in the general population

    Directory of Open Access Journals (Sweden)

    Menz Hylton B

    2011-09-01

    Full Text Available Abstract Background Symptomatic osteoarthritis (OA affects approximately 10% of adults aged over 60 years. The foot joint complex is commonly affected by OA, yet there is relatively little research into OA of the foot, compared with other frequently affected sites such as the knee and hand. Existing epidemiological studies of foot OA have focussed predominantly on the first metatarsophalangeal joint at the expense of other joints. This three-year prospective population-based observational cohort study will describe the prevalence of symptomatic radiographic foot OA, relate its occurrence to symptoms, examination findings and life-style-factors, describe the natural history of foot OA, and examine how it presents to, and is diagnosed and managed in primary care. Methods All adults aged 50 years and over registered with four general practices in North Staffordshire, UK, will be invited to participate in a postal Health Survey questionnaire. Respondents to the questionnaire who indicate that they have experienced foot pain in the preceding twelve months will be invited to attend a research clinic for a detailed clinical assessment. This assessment will consist of: clinical interview; physical examination; digital photography of both feet and ankles; plain x-rays of both feet, ankles and hands; ultrasound examination of the plantar fascia; anthropometric measurement; and a further self-complete questionnaire. Follow-up will be undertaken in consenting participants by postal questionnaire at 18 months (clinic attenders only and three years (clinic attenders and survey participants, and also by review of medical records. Discussion This three-year prospective epidemiological study will combine survey data, comprehensive clinical, x-ray and ultrasound assessment, and review of primary care records to identify radiographic phenotypes of foot OA in a population of community-dwelling older adults, and describe their impact on symptoms, function and

  7. A randomized, controlled clinical trial: the effect of mindfulness-based cognitive therapy on generalized anxiety disorder among Chinese community patients: protocol for a randomized trial

    Directory of Open Access Journals (Sweden)

    Wong Samuel YS

    2011-11-01

    Full Text Available Abstract Background Research suggests that an eight-week Mindfulness-Based Cognitive Therapy (MBCT program may be effective in the treatment of generalized anxiety disorders. Our objective is to compare the clinical effectiveness of the MBCT program with a psycho-education programme and usual care in reducing anxiety symptoms in people suffering from generalized anxiety disorder. Methods A three armed randomized, controlled clinical trial including 9-month post-treatment follow-up is proposed. Participants screened positive using the Structure Clinical Interview for DSM-IV (SCID for general anxiety disorder will be recruited from community-based clinics. 228 participants will be randomly allocated to the MBCT program plus usual care, psycho-education program plus usual care or the usual care group. Validated Chinese version of instruments measuring anxiety and worry symptoms, depression, quality of life and health service utilization will be used. Our primary end point is the change of anxiety and worry score (Beck Anxiety Inventory and Penn State Worry Scale from baseline to the end of intervention. For primary analyses, treatment outcomes will be assessed by ANCOVA, with change in anxiety score as the baseline variable, while the baseline anxiety score and other baseline characteristics that significantly differ between groups will serve as covariates. Conclusions This is a first randomized controlled trial that compare the effectiveness of MBCT with an active control, findings will advance current knowledge in the management of GAD and the way that group intervention can be delivered and inform future research. Unique Trail Number (assigned by Centre for Clinical Trails, Clinical Trials registry, The Chinese University of Hong Kong: CUHK_CCT00267

  8. Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control

    DEFF Research Database (Denmark)

    Sibilitz, Kirstine Laerum; Berg, Selina Kikkenborg; Hansen, Tina Birgitte;

    2015-01-01

    cost-benefit will be assessed. A mixed-method design will be used to evaluate qualitative and quantitative findings, encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. CONCLUSION: This randomized clinical trial will contribute with evidence of whether...... cardiac rehabilitation should be provided after heart valve surgery. The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). TRIAL REGISTRATION: Trial registered 16 March 2012; ClinicalTrials.gov ( NCT01558765 )....

  9. Clinical course, characteristics and prognostic indicators in patients presenting with back and leg pain in primary care. The ATLAS study protocol

    Directory of Open Access Journals (Sweden)

    Konstantinou Kika

    2012-01-01

    Full Text Available Abstract Background Low-back related leg pain with or without nerve root involvement is associated with a poor prognosis compared to low back pain (LBP alone. Compared to the literature investigating prognostic indicators of outcome for LBP, there is limited evidence on prognostic factors for low back-related leg pain including the group with nerve root pain. This 1 year prospective consultation-based observational cohort study will describe the clinical, imaging, demographic characteristics and health economic outcomes for the whole cohort, will investigate differences and identify prognostic indicators of outcome (i.e. change in disability at 12 months, for the whole cohort and, separately, for those classified with and without nerve root pain. In addition, nested qualitative studies will provide insights on the clinical consultation and the impact of diagnosis and treatment on patients' symptom management and illness trajectory. Methods Adults aged 18 years and over consulting their General Practitioner (GP with LBP and radiating leg pain of any duration at (n = 500 GP practices in North Staffordshire and Stoke-on-Trent, UK will be invited to participate. All participants will receive a standardised assessment at the clinic by a study physiotherapist and will be classified according to the clinically determined presence or absence of nerve root pain/involvement. All will undergo a lumbar spine MRI scan. All participants will be managed according to their clinical need. The study outcomes will be measured at 4 and 12 months using postal self-complete questionnaires. Data will also be collected each month using brief postal questionnaires to enable detailed description of the course of low back and leg pain over time. Clinical observations and patient interviews will be used for the qualitative aspects of the study. Discussion This prospective clinical observational cohort will combine self-reported data, comprehensive clinical and MRI

  10. Mobile internet protocol analysis

    OpenAIRE

    Brachfeld, Lawrence J.

    1999-01-01

    Mobile Internet Protocol (IP) is a proposed standard that builds on the current Internet Protocol by making the fact that a user is mobile transparent to applications and higher level protocols such as Transmission Control Protocol (TCP) and User Datagram Protocol (UDP). Mobile IP allows mobile computers to send and receive packets addressed with their home network IP address, regardless of the IP address of their current point of attachment on the Internet while maintaining any current conne...

  11. Coded Splitting Tree Protocols

    DEFF Research Database (Denmark)

    Sørensen, Jesper Hemming; Stefanovic, Cedomir; Popovski, Petar

    2013-01-01

    This paper presents a novel approach to multiple access control called coded splitting tree protocol. The approach builds on the known tree splitting protocols, code structure and successive interference cancellation (SIC). Several instances of the tree splitting protocol are initiated, each...... as possible. Evaluations show that the proposed protocol provides considerable gains over the standard tree splitting protocol applying SIC. The improvement comes at the expense of an increased feedback and receiver complexity....

  12. Genome-wide association study of virologic response with efavirenz-containing or abacavir-containing regimens in AIDS clinical trials group protocols

    NARCIS (Netherlands)

    Lehmann, David S; Ribaudo, Heather J; Daar, Eric S; Gulick, Roy M; Haubrich, Richard H; Robbins, Gregory K; de Bakker, Paul I W; Haas, David W; McLaren, Paul J

    2015-01-01

    BACKGROUND: Efavirenz and abacavir are components of recommended first-line regimens for HIV-1 infection. We used genome-wide genotyping and clinical data to explore genetic associations with virologic failure among patients randomized to efavirenz-containing or abacavir-containing regimens in AIDS

  13. Virtual patients design and its effect on clinical reasoning and student experience: a protocol for a randomised factorial multi-centre study

    Directory of Open Access Journals (Sweden)

    Bateman James

    2012-08-01

    Full Text Available Abstract Background Virtual Patients (VPs are web-based representations of realistic clinical cases. They are proposed as being an optimal method for teaching clinical reasoning skills. International standards exist which define precisely what constitutes a VP. There are multiple design possibilities for VPs, however there is little formal evidence to support individual design features. The purpose of this trial is to explore the effect of two different potentially important design features on clinical reasoning skills and the student experience. These are the branching case pathways (present or absent and structured clinical reasoning feedback (present or absent. Methods/Design This is a multi-centre randomised 2x2 factorial design study evaluating two independent variables of VP design, branching (present or absent, and structured clinical reasoning feedback (present or absent.The study will be carried out in medical student volunteers in one year group from three university medical schools in the United Kingdom, Warwick, Keele and Birmingham. There are four core musculoskeletal topics. Each case can be designed in four different ways, equating to 16 VPs required for the research. Students will be randomised to four groups, completing the four VP topics in the same order, but with each group exposed to a different VP design sequentially. All students will be exposed to the four designs. Primary outcomes are performance for each case design in a standardized fifteen item clinical reasoning assessment, integrated into each VP, which is identical for each topic. Additionally a 15-item self-reported evaluation is completed for each VP, based on a widely used EViP tool. Student patterns of use of the VPs will be recorded. In one centre, formative clinical and examination performance will be recorded, along with a self reported pre and post-intervention reasoning score, the DTI. Our power calculations indicate a sample size of 112 is required for

  14. Concurrent Chemoradiotherapy Followed by Consolidation Chemotherapy With Bi-Weekly Docetaxel and Carboplatin for Stage III Unresectable, Non-Small-Cell Lung Cancer: Clinical Application of a Protocol Used in a Previous Phase II Study

    International Nuclear Information System (INIS)

    Purpose: To assess the clinical applicability of a protocol evaluated in a previously reported phase II study of concurrent chemoradiotherapy followed by consolidation chemotherapy with bi-weekly docetaxel and carboplatin in patients with stage III, unresectable, non-small-cell lung cancer (NSCLC). Methods and Materials: Between January 2000 and March 2006, 116 previously untreated patients with histologically proven, stage III NSCLC were treated with concurrent chemoradiotherapy. Radiation therapy was administered in 2-Gy daily fractions to a total dose of 60 Gy in combination with docetaxel, 30 mg/m2, and carboplatin at an area under the curve value of 3 every 2 weeks during and after radiation therapy. Results: The median survival time for the entire group was 25.5 months. The actuarial 2-year and 5-year overall survival rates were 53% and 31%, respectively. The 3-year cause-specific survival rate was 60% in patients with stage IIIA disease, whereas it was 35% in patients with stage IIIB disease (p = 0.007). The actuarial 2-year and 5-year local control rates were 62% and 55%, respectively. Acute hematologic toxicities of Grade ≥3 severity were observed in 20.7% of patients, while radiation pneumonitis and esophagitis of Grade ≥3 severity were observed in 2.6% and 1.7% of patients, respectively. Conclusions: The feasibility of the protocol used in the previous phase II study was reconfirmed in this series, and excellent treatment results were achieved.

  15. Low omega-6 vs. low omega-6 plus high omega-3 dietary intervention for Chronic Daily Headache: Protocol for a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Smith Sunyata

    2011-04-01

    Full Text Available Abstract Background Targeted analgesic dietary interventions are a promising strategy for alleviating pain and improving quality of life in patients with persistent pain syndromes, such as chronic daily headache (CDH. High intakes of the omega-6 (n-6 polyunsaturated fatty acids (PUFAs, linoleic acid (LA and arachidonic acid (AA may promote physical pain by increasing the abundance, and subsequent metabolism, of LA and AA in immune and nervous system tissues. Here we describe methodology for an ongoing randomized clinical trial comparing the metabolic and clinical effects of a low n-6, average n-3 PUFA diet, to the effects of a low n-6 plus high n-3 PUFA diet, in patients with CDH. Our primary aim is to determine if: A both diets reduce n-6 PUFAs in plasma and erythrocyte lipid pools, compared to baseline; and B the low n-6 plus high n-3 diet produces a greater decline in n-6 PUFAs, compared to the low n-6 diet alone. Secondary clinical outcomes include headache-specific quality-of-life, and headache frequency and intensity. Methods Adults meeting the International Classification of Headache Disorders criteria for CDH are included. After a 6-week baseline phase, participants are randomized to a low n-6 diet, or a low n-6 plus high n-3 diet, for 12 weeks. Foods meeting nutrient intake targets are provided for 2 meals and 2 snacks per day. A research dietitian provides intensive dietary counseling at 2-week intervals. Web-based intervention materials complement dietitian advice. Blood and clinical outcome data are collected every 4 weeks. Results Subject recruitment and retention has been excellent; 35 of 40 randomized participants completed the 12-week intervention. Preliminary blinded analysis of composite data from the first 20 participants found significant reductions in erythrocyte n-6 LA, AA and %n-6 in HUFA, and increases in n-3 EPA, DHA and the omega-3 index, indicating adherence. Trial Registration ClinicalTrials.gov (NCT01157208

  16. A PROGRAMMED LABOUR - PROTOCOL

    Directory of Open Access Journals (Sweden)

    Savita

    2014-12-01

    Full Text Available A Prospective randomized Clinical study of outcome of labour following. “A Programmed labour. Protocol” was done at Department of OBG, MRMC Gulbarga. The Protocol was aimed with dual. Objective of Providing Pain relief during labour and teaching the goal of safe motherhood by optimizing objective outcome. AIMS AND OBJECTIVES: Shortening of duration of labour. Effect of labour analgesia. Monitoring of the events during labour. Lowering the incidence of operative deliveries. METHODS: 100 cases primi pregnant women admitted in labour room are randomly selected. It is designed to apply to low risk primi parous, singleton cephalic presentation without evidence of CPD and spontaneous onset of labour. RESULTS: Shortened duration of all the stages of Labour, especially significant reduction in duration of active phase of labour. CONCLUSION: The programmed labour is simple easy and effective method for painless and safe delivery.

  17. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    OpenAIRE

    Krämer Jürgen; Knauer Christine; Mansmann Ulrich; Witte Steffen; Streitberger Konrad; Scharf Hanns-Peter; Victor Norbert

    2004-01-01

    Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third co...

  18. COSMOS-improving the quality of life in nursing home patients: Protocol for an effectiveness-implementation cluster randomized clinical hybrid trial

    OpenAIRE

    Husebø, Bettina; Flo, Elisabeth; Aarsland, Dag; Selbæk, Geir; Testad, Ingelin; Gulla, Christine; Aasmul, Irene; Ballard, Clive

    2015-01-01

    Background Nursing home patients have complex mental and physical health problems, disabilities and social needs, combined with widespread prescription of psychotropic drugs. Preservation of their quality of life is an important goal. This can only be achieved within nursing homes that offer competent clinical conditions of treatment and care. COmmunication, Systematic assessment and treatment of pain, Medication review, Occupational therapy, Safety (COSMOS) is an effectiveness-implementation...

  19. Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial

    OpenAIRE

    Al Balushi, Ruqaiya M; Paratz, Jennifer D.; Cohen, Jeremy; Banks, Merrilyn; Dulhunty, Joel; Roberts, Jason A.; Lipman, Jeffrey

    2011-01-01

    Background Trauma patients are characterised by alterations in the immune system, increased exposure to infectious complications, sepsis and potentially organ failure and death. Glutamine supplementation to parenteral nutrition has been proven to be associated with improved clinical outcomes. However, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. Previous trials have been limited by a small sample size, use of surrogate outcomes ...

  20. Using theories of behaviour to understand transfusion prescribing in three clinical contexts in two countries: Development work for an implementation trial (protocol)

    OpenAIRE

    Francis, J.; Tinmouth, A; Stanworth, S.; J.M. Grimshaw; Johnston, M.; Hyde, C.; Brehaut, J.; Stockton, C; Fergusson, D.; Eccles, M. P.

    2009-01-01

    Background: Blood transfusion is an essential part of healthcare and can improve patient outcomes. However, like most therapies, it is also associated with significant clinical risks. In addition, there is some evidence of overuse. Understanding the potential barriers and enablers to reduced prescribing of blood products will facilitate the selection of intervention components likely to be effective, thereby reducing the number of costly trials evaluating different implementation strategies. ...

  1. The Obesity-Fertility Protocol: a randomized controlled trial assessing clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women

    OpenAIRE

    Duval, Karine; Langlois, Marie-France; Carranza-Mamane, Belina; Pesant, Marie-Hélène; Hivert, Marie-France; Poder, Thomas G; Lavoie, Hélène B.; Ainmelk, Youssef; St-Cyr Tribble, Denise; Laredo, Sheila; Greenblatt, Ellen; Sagle, Margaret; Waddell, Guy; Belisle, Serge; Riverin, Daniel

    2015-01-01

    Background Obesity in infertile women increases the costs of fertility treatments, reduces their effectiveness and increases significantly the risks of many complications of pregnancy and for the newborn. Studies suggest that even a modest loss of 5–10 % of body weight can restore ovulation. However, there are gaps in knowledge regarding the benefits and cost-effectiveness of a lifestyle modification program targeting obese infertile women and integrated into the fertility clinics. This study...

  2. A cluster randomized trial to improve adherence to evidence-based guidelines on diabetes and reduce clinical inertia in primary care physicians in Belgium: study protocol [NTR 1369

    Directory of Open Access Journals (Sweden)

    Ivanova Anna

    2008-10-01

    Full Text Available Abstract Background Most quality improvement programs in diabetes care incorporate aspects of clinician education, performance feedback, patient education, care management, and diabetes care teams to support primary care physicians. Few studies have applied all of these dimensions to address clinical inertia. Aim To evaluate interventions to improve adherence to evidence-based guidelines for diabetes and reduce clinical inertia in primary care physicians. Design Two-arm cluster randomized controlled trial. Participants Primary care physicians in Belgium. Interventions Primary care physicians will be randomly allocated to 'Usual' (UQIP or 'Advanced' (AQIP Quality Improvement Programs. Physicians in the UQIP will receive interventions addressing the main physician, patient, and office system factors that contribute to clinical inertia. Physicians in the AQIP will receive additional interventions that focus on sustainable behavior changes in patients and providers. Outcomes Primary endpoints are the proportions of patients within targets for three clinical outcomes: 1 glycosylated hemoglobin Primary and secondary analysis Statistical analyses will be performed using an intent-to-treat approach with a multilevel model. Linear and generalized linear mixed models will be used to account for the clustered nature of the data, i.e., patients clustered withinimary care physicians, and repeated assessments clustered within patients. To compare patient characteristics at baseline and between the intervention arms, the generalized estimating equations (GEE approach will be used, taking the clustered nature of the data within physicians into account. We will also use the GEE approach to test for differences in evolution of the primary and secondary endpoints for all patients, and for patients in the two interventions arms, accounting for within-patient clustering. Trial Registration number: NTR 1369.

  3. ‘Third wave’ cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial

    OpenAIRE

    Jakobsen Janus Christian; Gluud Christian; Kongerslev Mickey; Larsen Kirsten Aaskov; Sørensen Per; Winkel Per; Lange Theis; Søgaard Ulf; Simonsen Erik

    2012-01-01

    Abstract Background Most interventions for depression have shown small or no effects. ‘Third wave‘ cognitive therapy and mentalization-based therapy have both gained some ground as treatments of psychological problems. No randomised trial has compared the effects of these two interventions for patients with major depression. Methods/ design We plan a randomised, parallel group, assessor-blinded superiority clinical trial. During two years we will include 84 consecutive adult participants diag...

  4. Does accountability for reasonableness work? A protocol for a mixed methods study using an audit tool to evaluate the decision-making of clinical commissioning groups in England

    OpenAIRE

    Kieslich, Katharina; Littlejohns, Peter

    2015-01-01

    Introduction Clinical commissioning groups (CCGs) in England are tasked with making difficult decisions on which healthcare services to provide against the background of limited budgets. The question is how to ensure that these decisions are fair and legitimate. Accounts of what constitutes fair and legitimate priority setting in healthcare include Daniels’ and Sabin's accountability for reasonableness (A4R) and Clark's and Weale's framework for the identification of social values. This study...

  5. Prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizophrenia: a randomized clinical trial - the SMART trial protocol

    DEFF Research Database (Denmark)

    Baandrup, Lone; Fagerlund, Birgitte; Jennum, Poul; Lublin, Henrik; Hansen, Jane L; Winkel, Per; Gluud, Christian Nyfeldt; Oranje, Bob; Glenthoj, Birte Y

    2011-01-01

    Treatment of schizophrenia frequently includes prolonged benzodiazepine administration despite a lack of evidence of its use. It is often difficult to discontinue benzodiazepines because of the development of dependence. We aim to assess if melatonin can facilitate the withdrawal of prolonged...... benzodiazepine administration in patients with schizophrenia. Furthermore, we aim to investigate the association of benzodiazepine dose reduction with the following clinically important variables: sleep, psychophysiology, cognition, social function, and quality of life....

  6. Prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizophrenia: a randomized clinical trial - the SMART trial protocol

    OpenAIRE

    Oranje Bob; Gluud Christian; Winkel Per; Hansen Jane L; Lublin Henrik; Jennum Poul; Fagerlund Birgitte; Baandrup Lone; Glenthoj Birte Y

    2011-01-01

    Abstract Background Treatment of schizophrenia frequently includes prolonged benzodiazepine administration despite a lack of evidence of its use. It is often difficult to discontinue benzodiazepines because of the development of dependence. We aim to assess if melatonin can facilitate the withdrawal of prolonged benzodiazepine administration in patients with schizophrenia. Furthermore, we aim to investigate the association of benzodiazepine dose reduction with the following clinically importa...

  7. Clinical and genetic characteristics of acute myeloid leukemia with t(8;21 in children and results of therapy according to protocol AML-MM-2000

    Directory of Open Access Journals (Sweden)

    I. I. Kalinina

    2014-07-01

    Full Text Available A t(8;21 is the most frequent abnormality in AML in children. Patients with this genetic abnormality are traditionally expected favorable prognosis with a probability of cure up to 80 %. Known additional cytogenetic abnormalities in AML with t(8;21 not affecting prognosis. These include loss of one sex chromosome and del(9q-. Prognosis impact of additional abnormalities involving chromosomes 7 and 11 in patients with t(8;21 is unknown. The purpose of this study was to analyse of additional anomalies, that occur in patients with t(8;21, and their influence on prognosis. During the study period 173 children with AML have received AML-MM-2000 treatment protocol in Russia and Belarus. Of these, in 33 patients (11 girls and 22 boys, median age — 10.5 years t(8;21 was detected by chromosome banding or molecular-genetic analysis. In group with t(8;21 CNS leukemia in 8 patients was detected, extramedullary lesion — in 8 patients. In 4 patients CNS leukemia combined with presence of extramedullary lesions. These factors did not influence on therapy outcome. Overall survival of AML patients with t(8;21 was 0,67 ± 0,08 compared to 0,44 ± 0,04 in patients with AML without this translocation (p = 0,04. Special subgroup consist of 5 patients with t(8;21 and identified chromosomal abnormalities affecting chromosome 7 and 11, which were a poor prognostic factor: event-free survival in this subgroup of patients (n = 5 was 0,0 ± 0,0, compared to 0,34 ± 0,16 in patients with t(8;21 without additional anomalies (n = 28 (p = 0,027.

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

    Directory of Open Access Journals (Sweden)

    Farmer Andrew J

    2011-05-01

    Full Text Available Abstract Background Trial research has predominantly focused on patient and staff understandings of trial concepts and/or motivations for taking part, rather than why treatment recommendations may or may not be followed during trial delivery. This study sought to understand why there was limited attainment of the glycaemic target (HbA1c ≤6.5% among patients who participated in the Treating to Target in Type 2 Diabetes Trial (4-T. The objective was to inform interpretation of trial outcomes and provide recommendations for future trial delivery. Methods In-depth interviews were conducted with 45 patients and 21 health professionals recruited from 11 of 58 trial centres in the UK. Patients were broadly representative of those in the main trial in terms of treatment allocation, demographics and glycaemic control. Both physicians and research nurses were interviewed. Results Most patients were committed to taking insulin as recommended by 4-T staff. To avoid hypoglycaemia, patients occasionally altered or skipped insulin doses, normally in consultation with staff. Patients were usually unaware of the trial's glycaemic target. Positive staff feedback could lead patients to believe they had been 'successful' trial participants even when their HbA1c exceeded 6.5%. While some staff felt that the 4-T automated insulin dose adjustment algorithm had increased their confidence to prescribe larger insulin doses than in routine clinical practice, all described situations where they had not followed its recommendations. Staff regarded the application of a 'one size fits all' glycaemic target during the trial as contradicting routine clinical practice where they would tailor treatments to individuals. Staff also expressed concerns that 'tight' glycaemic control might impose an unacceptably high risk of hypoglycaemia, thus compromising trust and safety, especially amongst older patients. To address these concerns, staff tended to adapt the trial protocol to

  9. Study protocol for a randomised, double-blinded, placebo-controlled, clinical trial of S-ketamine for pain treatment in patients with chronic pancreatitis (RESET trial)

    DEFF Research Database (Denmark)

    Juel, Jacob; Olesen, Søren Schou; Olesen, Anne Estrup;

    2015-01-01

    central sensitisation is abnormal activation of the N-methyl-D-aspartate receptor, which can be antagonised by S-ketamine. The RESET trial is investigating the analgaesic and antihyperalgesic effect of S-ketamine in patients with CP. METHODS AND ANALYSIS: 40 patients with CP will be enrolled. Patients are...... randomised to receive 8 h of intravenous S-ketamine followed by oral S-ketamine, or matching placebo, for 4 weeks. To improve blinding, 1 mg of midazolam will be added to active and placebo treatment. The primary end point is clinical pain relief as assessed by a daily pain diary. Secondary end points...

  10. The effect of education and supervised exercise vs. education alone on the time to total hip replacement in patients with severe hip osteoarthritis. A randomized clinical trial protocol

    DEFF Research Database (Denmark)

    Jensen, Carsten; Roos, Ewa M.; Kjærsgaard-Andersen, Per;

    2013-01-01

    receive 3 months of supervised exercise consisting of 12 sessions of individualized, goal-based neuromuscular training, and 12 sessions of intensive resistance training plus patient education (3 sessions). The control group will receive only patient education (3 sessions). The primary end-point for...... muscle function and performance in physical tests. A cost-effectiveness analysis will also be performed. Discussion: To our knowledge, this is the first randomized clinical trial comparing a patient education plus supervised exercise program to patient education alone in hip osteoarthritis patients with...

  11. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Arce Roger M

    2011-02-01

    Full Text Available Abstract Background Periodontal disease (PD is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group or supragingival plaque removal only (control group. A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98 and all patients will be followed-up for secondary outcomes and will be monitored

  12. Rationale, design, and implementation protocol of an electronic health record integrated clinical prediction rule (iCPR randomized trial in primary care

    Directory of Open Access Journals (Sweden)

    Wisnivesky Juan

    2011-09-01

    Full Text Available Abstract Background Clinical prediction rules (CPRs represent well-validated but underutilized evidence-based medicine tools at the point-of-care. To date, an inability to integrate these rules into an electronic health record (EHR has been a major limitation and we are not aware of a study demonstrating the use of CPR's in an ambulatory EHR setting. The integrated clinical prediction rule (iCPR trial integrates two CPR's in an EHR and assesses both the usability and the effect on evidence-based practice in the primary care setting. Methods A multi-disciplinary design team was assembled to develop a prototype iCPR for validated streptococcal pharyngitis and bacterial pneumonia CPRs. The iCPR tool was built as an active Clinical Decision Support (CDS tool that can be triggered by user action during typical workflow. Using the EHR CDS toolkit, the iCPR risk score calculator was linked to tailored ordered sets, documentation, and patient instructions. The team subsequently conducted two levels of 'real world' usability testing with eight providers per group. Usability data were used to refine and create a production tool. Participating primary care providers (n = 149 were randomized and intervention providers were trained in the use of the new iCPR tool. Rates of iCPR tool triggering in the intervention and control (simulated groups are monitored and subsequent use of the various components of the iCPR tool among intervention encounters is also tracked. The primary outcome is the difference in antibiotic prescribing rates (strep and pneumonia iCPR's encounters and chest x-rays (pneumonia iCPR only between intervention and control providers. Discussion Using iterative usability testing and development paired with provider training, the iCPR CDS tool leverages user-centered design principles to overcome pervasive underutilization of EBM and support evidence-based practice at the point-of-care. The ongoing trial will determine if this collaborative

  13. Transfer of manualized CBT for social phobia into clinical practice (SOPHO-PRAX: a study protocol for a cluster-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Crawcour Stephen

    2012-05-01

    Full Text Available Abstract Background Cognitive-behavioral therapy (CBT is generally known to be efficacious in the treatment of social phobia when applied in RCTs, namely when the treatment manual is based on the Clark-Wells approach. However, little is known about the efficacy of manualized treatments in routine clinical practice (Phase IV of psychotherapy research. The present study (SOPHO-PRAX is a continuation of a large multicenter randomized clinical trial (SOPHO-NET and analyzes the extent to which additional training practitioners in manualized procedures enhances treatment effect. Methods/design Thirty-six private practitioners will be included in three treatment centers and randomly designated to either training in manualized CBT or no specific training. The treatment effects of the therapies conducted by both groups of therapists will be compared. A total of 162 patients (n = 116 completers; n = 58 per condition will be enrolled. Liebowitz Social Anxiety Scale (LSAS will serve as primary outcome measure. Remission from social phobia is defined as LSAS total ≤30 points. Data will be collected at treatment begin, after 8, 15, and 25 sessions (50 min each, at treatment completion, as well at 6 and 12 months post-treatment. Discussion The present CBT trial combines elements of randomized controlled trials and naturalistic studies in an innovative way. It will directly inform about the incremental effects of procedures established in a controlled trial into clinical practice. Study results are relevant to healthcare decisions and policy. They may serve to improve quality of treatment, and shorten the time frame between the development and widespread dissemination of effective methods, thereby reducing health cost expenditure. The results of this study will not only inform about the degree to which the new methods lead to an improvement of treatment course and outcome, but also about whether the effects of routine psychotherapeutic treatment

  14. The neurophysiological effects of dry needling in patients with upper trapezius myofascial trigger points: study protocol of a controlled clinical trial

    OpenAIRE

    Abbaszadeh-Amirdehi, Maryam; Ansari, Noureddin Nakhostin; Naghdi, Soofia; Olyaei, Gholamreza; Nourbakhsh, Mohammad Reza

    2013-01-01

    Introduction Dry needling (DN) is an effective method for the treatment of myofascial trigger points (MTrPs). There is no report on the neurophysiological effects of DN in patients with MTrPs. The aim of the present study will be to assess the immediate neurophysiological efficacy of deep DN in patients with upper trapezius MTrPs. Methods and analysis A prospective, controlled clinical trial was designed to include patients with upper trapezius MTrPs and volunteered healthy participants to re...

  15. ‘Third wave’ cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Jakobsen Janus Christian

    2012-12-01

    Full Text Available Abstract Background Most interventions for depression have shown small or no effects. ‘Third wave‘ cognitive therapy and mentalization-based therapy have both gained some ground as treatments of psychological problems. No randomised trial has compared the effects of these two interventions for patients with major depression. Methods/ design We plan a randomised, parallel group, assessor-blinded superiority clinical trial. During two years we will include 84 consecutive adult participants diagnosed with major depressive disorder. The participants will be randomised to either ‘third wave‘ cognitive therapy versus mentalization-based therapy. The primary outcome will be the Hamilton Rating Scale for Depression at cessation of treatment at 18 weeks. Secondary outcomes will be the proportion of patients with remission, Symptom Checklist 90 Revised, Beck’s Depression Inventory, and The World Health Organisation-Five Well-being Index 1999. Discussion Interventions for depression have until now shown relatively small effects. Our trial results will provide knowledge about the effects of two modern psychotherapeutic interventions. Trial registration ClinicalTrials: NCT01070134

  16. Efficacy and tolerance of the topical application of potassium hydroxide (10% and 15% in the treatment of molluscum contagiosum: Randomized clinical trial: Research protocol

    Directory of Open Access Journals (Sweden)

    Galindo Gisela

    2011-10-01

    Full Text Available Abstract Background Molluscum contagiosum is a non-severe pediatric viral infection. Because it is highly contagious and current treatments have negative aesthetic and psychological effects, we want to test an alternative treatment in the primary care setting, consisting of two different concentrations of potassium hydroxide solution. Methods/design The study design is a double-blind, randomized clinical trial, using three types of topical treatment. The treatment consist of daily applications of potassium hydroxide (KOH in aqueous solution at 10% and 15% concentration, and a placebo administered in the control group. Four follow-up visits (at 15, 30, 45 and 60 days are planned to evaluate treatment effectiveness and patient tolerance. The main outcome measure of the trial will be the healing rate, defined as lesion disappearance in the affected zones after the topic application of the experimental treatment. Secondary measures will be the principal characteristics and evolution of the affected zone (surface area, number of lesions, size and density of lesions, treatment tolerance (hyperpigmentation, itching, burning, pain, recurrence rate and the natural evolution of lesions in the control group. Discussion KOH can potentially be an effective and safe treatment for MC in primary care, and can also reduce referrals to dermatologists and hospital pediatric departments. In addition, KOH may be a valid and less expensive alternative to current invasive treatments (surgical excision. Trial Registration ClinicalTrials.gov: NCT01348386

  17. Screening uptake rates and the clinical and cost effectiveness of screening for gestational diabetes mellitus in primary versus secondary care: study protocol for a randomised controlled trial.

    LENUS (Irish Health Repository)

    O Dea, Angela

    2014-01-17

    The risks associated with gestational diabetes mellitus (GDM) are well recognized, and there is increasing evidence to support treatment of the condition. However, clear guidance on the ideal approach to screening for GDM is lacking. Professional groups continue to debate whether selective screening (based on risk factors) or universal screening is the most appropriate approach. Additionally, there is ongoing debate about what levels of glucose abnormalities during pregnancy respond best to treatment and which maternal and neonatal outcomes benefit most from treatment. Furthermore, the implications of possible screening options on health care costs are not well established. In response to this uncertainty there have been repeated calls for well-designed, randomised trials to determine the efficacy of screening, diagnosis, and management plans for GDM. We describe a randomised controlled trial to investigate screening uptake rates and the clinical and cost effectiveness of screening in primary versus secondary care settings. The objective of this study is to assess screening uptake rates, and the clinical and cost effectiveness of screening for GDM in primary versus secondary care.

  18. Clinical evidence continuous medical education: a randomised educational trial of an open access e-learning program for transferring evidence-based information – ICEKUBE (Italian Clinical Evidence Knowledge Utilization Behaviour Evaluation – study protocol

    Directory of Open Access Journals (Sweden)

    Satolli Roberto

    2008-07-01

    Full Text Available Abstract Background In an effort to ensure that all physicians have access to valid and reliable evidence on drug effectiveness, the Italian Drug Agency sponsored a free-access e-learning system, based on Clinical Evidence, called ECCE. Doctors have access to an electronic version and related clinical vignettes. Correct answers to the interactive vignettes provide Continuing Medical Education credits. The aims of this trial are to establish whether the e-learning program (ECCE increases physicians' basic knowledge about common clinical scenarios, and whether ECCE is superior to the passive diffusion of information through the printed version of Clinical Evidence. Design All Italian doctors naïve to ECCE will be randomised to three groups. Group one will have access to ECCE for Clinical Evidence chapters and vignettes lot A and will provide control data for Clinical Evidence chapters and vignettes lot B; group two vice versa; group three will receive the concise printed version of Clinical Evidence. There are in fact two designs: a before and after pragmatic trial utilising a two by two incomplete block design (group one versus group two and a classical design (group one and two versus group three. The primary outcome will be the retention of Clinical Evidence contents assessed from the scores for clinical vignettes selected from ECCE at least six months after the intervention. To avoid test-retest effects, we will randomly select vignettes out of lot A and lot B, avoiding repetitions. In order to preserve the comparability of lots, we will select vignettes with similar, optimal psychometric characteristics. Trial registration ISRCTN27453314

  19. Research on Protocol Migration

    Institute of Scientific and Technical Information of China (English)

    汪芸; 顾冠群; 等

    1996-01-01

    This paper elaborates the concept and model of protocol migration in network interconnection.Migration strategies and principles are discussed and several cases are studied in detail which show the basic procedure and techniques used in protocol migration.

  20. Comparative efficacy of two primary care interventions to assist withdrawal from long term benzodiazepine use: A protocol for a clustered, randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Roca Miguel

    2011-04-01

    Full Text Available Abstract Background Although benzodiazepines are effective, long-term use is not recommended because of potential adverse effects; the risks of tolerance and dependence; and an increased risk of hip fractures, motor vehicle accidents, and memory impairment. The estimated prevalence of long-term benzodiazepine use in the general population is about 2,2 to 2,6%, is higher in women and increases steadily with age. Interventions performed by General Practitioners may help patients to discontinue long-term benzodiazepine use. We have designed a trial to evaluate the effectiveness and safety of two brief general practitioner-provided interventions, based on gradual dose reduction, and will compare the effectiveness of these interventions with that of routine clinical practice. Methods/Design In a three-arm cluster randomized controlled trial, general practitioners will be randomly allocated to: a a group in which the first patient visit will feature a structured interview, followed by visits every 2-3 weeks to the end of dose reduction; b a group in which the first patient visit will feature a structured interview plus delivery of written instructions to self-reduce benzodiazepine dose, or c routine care. Using a computerized pharmaceutical prescription database, 495 patients, aged 18-80 years, taking benzodiazepine for at least 6 months, will be recruited in primary care health districts of three regions of Spain (the Balearic Islands, Catalonia, and Valencia. The primary outcome will be benzodiazepine use at 12 months. The secondary outcomes will include measurements of anxiety and depression symptoms, benzodiazepine dependence, quality of sleep, and alcohol consumption. Discussion Although some interventions have been shown to be effective in reducing benzodiazepine consumption by long-term users, the clinical relevance of such interventions is limited by their complexity. This randomized trial will compare the effectiveness and safety of two

  1. Defining the effect and mediators of two knowledge translation strategies designed to alter knowledge, intent and clinical utilization of rehabilitation outcome measures: a study protocol [NCT00298727

    Directory of Open Access Journals (Sweden)

    Law Mary

    2006-07-01

    Full Text Available Abstract Background A substantial number of valid outcome measures have been developed to measure health in adult musculoskeletal and childhood disability. Regrettably, national initiatives have merely resulted in changes in attitude, while utilization remains unacceptably low. This study will compare the effectiveness and mediators of two different knowledge transfer (KT interventions in terms of their impact on changing knowledge and behavior (utilization and clinical reasoning related to health outcome measures. Method/Design Physical and occupational therapists (n = 144 will be recruited in partnership with the national professional associations to evaluate two different KT interventions with the same curriculum: 1 Stakeholder-Hosted Interactive Problem-Based Seminar (SHIPS, and 2 Online Problem-Based course (e-PBL. SHIPS will consist of face-to-face problem-based learning (PBL for 2 1/2 days with outcome measure developers as facilitators, using six problems generated in consultation with participants. The e-PBL will consist of a 6-week web-based course with six generic problems developed by content experts. SHIPS will be conducted in three urban centers in Canada. Participants will be block-allocated by a minimization procedure to either of the two interventions to minimize any prognostic differences. Trained evaluators at each site will conduct chart audits and chart-stimulated recall. Trained interviewers will conduct semi-structured interviews focused on identifying critical elements in KT and implementing practice changes. Interviews will be transcribed verbatim. Baseline predictors including demographics, knowledge, attitudes/barriers regarding outcome measures, and Readiness to Change will be assessed by self-report. Immediately post-intervention and 6 months later, these will be re-administered. Primary qualitative and quantitative evaluations will be conducted 6-months post-intervention to assess the relative effectiveness of KT

  2. Prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizophrenia: a randomized clinical trial - the SMART trial protocol

    Directory of Open Access Journals (Sweden)

    Oranje Bob

    2011-10-01

    Full Text Available Abstract Background Treatment of schizophrenia frequently includes prolonged benzodiazepine administration despite a lack of evidence of its use. It is often difficult to discontinue benzodiazepines because of the development of dependence. We aim to assess if melatonin can facilitate the withdrawal of prolonged benzodiazepine administration in patients with schizophrenia. Furthermore, we aim to investigate the association of benzodiazepine dose reduction with the following clinically important variables: sleep, psychophysiology, cognition, social function, and quality of life. Methods/Design Randomized, blinded, two-armed, parallel superiority trial. We plan to include 80 consenting outpatients diagnosed with schizophrenia or schizoaffective disorder, 18-55 years of age, treated with antipsychotic drug(s and at least one benzodiazepine derivative for the last three months before inclusion. Exclusion criteria: currently under treatment for alcohol or drug abuse, aggressive or violent behavior, known mental retardation, pervasive developmental disorder, dementia, epilepsy, terminal illness, severe co morbidity, inability to understand Danish, allergy to melatonin, lactose, starch, gelatin, or talc, hepatic impairment, pregnancy or nursing, or lack of informed consent. After being randomized to prolonged-release melatonin (Circadin® 2 mg daily or matching placebo, participants are required to slowly taper off their benzodiazepine dose. The primary outcome measure is benzodiazepine dose at 6 months follow-up. Secondary outcome measures include sleep, psychophysiological, and neurocognitive measures. Data are collected at baseline and at 6 months follow-up regarding medical treatment, cognition, psychophysiology, sleep, laboratory tests, adverse events, psychopathology, social function, and quality of life. Data on medical treatment, cognition, psychophysiology, adverse events, social function, and quality of life are also collected at 2 and 4

  3. Clinical evidence continuous medical education: a randomised educational trial of an open access e-learning program for transferring evidence-based information – ICEKUBE (Italian Clinical Evidence Knowledge Utilization Behaviour Evaluation) – study protocol

    OpenAIRE

    Satolli Roberto; Manfrini Roberto; Clivio Luca; Deligant Christian; Duca Piergiorgio; Compagnoni Anna; Sala Valeria; Cinquini Michela; Moschetti Ivan; Moja Lorenzo; Addis Antonio; Grimshaw Jeremy M; Dri Pietro; Liberati Alessandro

    2008-01-01

    Abstract Background In an effort to ensure that all physicians have access to valid and reliable evidence on drug effectiveness, the Italian Drug Agency sponsored a free-access e-learning system, based on Clinical Evidence, called ECCE. Doctors have access to an electronic version and related clinical vignettes. Correct answers to the interactive vignettes provide Continuing Medical Education credits. The aims of this trial are to establish whether the e-learning program (ECCE) increases phys...

  4. Quetiapine versus aripiprazole in children and adolescents with psychosis--protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial

    DEFF Research Database (Denmark)

    Pagsberg, Anne Katrine; Jeppesen, Pia; Klauber, Dea Gowers;

    2014-01-01

    BACKGROUND: The evidence for choices between antipsychotics for children and adolescents with schizophrenia and other psychotic disorders is limited. The main objective of the Tolerability and Efficacy of Antipsychotics (TEA) trial is to compare the benefits and harms of quetiapine versus...... aripiprazole in children and adolescents with psychosis in order to inform rational, effective and safe treatment selections. METHODS/DESIGN: The TEA trial is a Danish investigator-initiated, independently funded, multi-centre, randomised, blinded clinical trial. Based on sample size estimation, 112 patients...... aged 12-17 years with psychosis, antipsychotic-naïve or treated for a limited period are, 1:1 randomised to a 12- week, double-blind intervention with quetiapine versus aripiprazole. Effects on psychopathology, cognition, health-related quality of life, and adverse events are assessed 2, 4, and 12...

  5. A comparison of Kneipp hydrotherapy with conventional physiotherapy in the treatment of osteoarthritis of the hip or knee: protocol of a prospective randomised controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Deutsch Tobias

    2009-08-01

    Full Text Available Abstract Background The increasing age of the population, especially in the western world, means that the prevalence of osteoarthritis is also increasing, with corresponding socioeconomic consequences. Although there is no curative intervention at present, in accordance with US and European guidelines, pharmacotherapeutic and non-pharmacological approaches aim at pain control and the reduction of functional restriction. It has been established that hydrotherapy for osteoarthritis of the hip or knee joint using serial cold and warm water stimulation not only improves the range of movement but also reduces pain significantly and increases quality of life over a period of up to three months. Weight reduction is important for patients with osteoarthritis of the hip or knee. In addition, conventional physiotherapy and exercise therapy have both been shown, at a high level of evidence, to be cost-effective and to have long-term benefits for pain relief, movement in the affected joint, and patient quality of life. Methods/design The study design consists of a prospective randomised controlled three-armed clinical trial, which will be carried out at a specialist clinic for integrative medicine, to investigate the clinical effects of hydrotherapy on osteoarthritis of the knee or hip joint, in comparison with conventional physiotherapy. One hundred and eighty patients diagnosed with osteoarthritis of hip or knee will be randomly assigned to one of three intervention groups: hydrotherapy, physiotherapy, and both physiotherapy and hydrotherapy of the affected joint. In the first group, patients will receive Kneipp hydrotherapy daily, with water applied in the form of alternate cold and warm thigh affusions (alternating cold and warm water stimulation is particularly relevant to the knee and hip regions. Patients in the second group will receive physiotherapy of the hip or knee joint three times a week. Patients in the physiotherapy-hydrotherapy combination

  6. Clinical effect of pricking blood at neiyingxiang (ExHN 9 on non-allergic rhinopathy: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kim Kyu

    2012-04-01

    Full Text Available Abstract Background Non-allergic rhinopathy (NAR, formerly known as vasomotor rhinitis, is a non-allergic and non-infectious chronic disease that is accompanied by nasal hyperemia, rhinorrhea, and no increase in the number of eosinophils. Although the medications for NAR, including intranasal corticosteroids and intranasal antihistamine, have been used in clinical practice, given the relative paucity of effective therapy with available medications, alternative non-pharmacologic treatments could play an important role in treating NAR. Acupuncture treatment is representative potential alternative therapy for the treatment of various diseases, including rhinitis. Therefore, the objective of this study was to evaluate the efficacy of pricking blood at Neiyingxiang (ExHN 9 relative to acupuncture treatment at Waiyingxiang (LI 20 in patients with NAR. Methods/Design A randomized, parallel-group, controlled, assessor single-blinded, trial will be conducted. Fifty participants with NAR will be randomized into one of two groups: either the control group with acpuncture treatment at LI 20 or the experimental group with pricking blood at ExHN 9. After randomization, a total of three sessions of treatment will be performed once a week in both groups. The total nasal symptom score (TNSS and the Mini-Rhinoconjunctivitis Quality-of-Life Questionnaire (MiniRQLQ at baseline and the end of the trial will be used to evaluate the efficacy of each treatment. Discussion This study will be the first randomized trial to evaluate the efficacy of pricking blood for the treatment of NAR. The results of this study will help establish an alternative approach for treating patients with NAR that do not respond to Western medication. Trial registration The trial was registered with the Clinical Research Information Service (CRiS, Republic of Korea: KCT0000195.

  7. Systematic evaluation of the clinical effects of supportive mistletoe treatment within chemo- and/or radiotherapy protocols and long-term mistletoe application in nonmetastatic colorectal carcinoma: multicenter, controlled, observational cohort study.

    Science.gov (United States)

    Friedel, Walter E; Matthes, Harald; Bock, Paul R; Zänker, Kurt S

    2009-01-01

    In Europe, patients with colorectal carcinoma (CRC) frequently receive mistletoe extracts to improve quality of life and survival. This study was designed to evaluate supportive treatment with mistletoe extract Iscador (ISC) in nonmetastatic CRC patients under routine clinical conditions and to create well-founded hypotheses for future prospective clinical studies. The design of a multicenter, controlled, retrospective, observational cohort study with parallel groups met the Good Epidemiological Practice rules. Anonymous unselected standardized data from eligible patients with surgically treated stage I-III CRC and adjuvant therapy (AT) or conventional aftercare were included. End points were adjuvant therapy-related adverse reactions (AT-ADRs), symptoms, and disease-free survival (DFS). The results were adjusted for confounder effects. Eight hundred four (429 ISC vs 375 control) CRC patients from 26 centers were observed for a median of 58 versus 51 months; the median ISC therapy lasted 52 months. ISC patients showed fewer AT-ADRs (19% vs 48%, p controls. ISC was well tolerated without life-threatening ADRs, drug interactions, or tumor enhancement. These results suggest a beneficial effect of supportive care ISC therapy within AT protocols and long-term ISC treatment in stage I-III CRC patients, particularly improvement in AT-ADRs and symptoms and possible extension of DFS. PMID:19883529

  8. Protocol Implementation Generator

    DEFF Research Database (Denmark)

    Carvalho Quaresma, Jose Nuno; Probst, Christian W.

    2010-01-01

    Users expect communication systems to guarantee, amongst others, privacy and integrity of their data. These can be ensured by using well-established protocols; the best protocol, however, is useless if not all parties involved in a communication have a correct implementation of the protocol and a...

  9. A clinically relevant BTX-A injection protocol leads to persistent weakness, contractile material loss, and an altered mRNA expression phenotype in rabbit quadriceps muscles.

    Science.gov (United States)

    Fortuna, Rafael; Vaz, Marco A; Sawatsky, Andrew; Hart, David A; Herzog, Walter

    2015-07-16

    Botulinum toxin type-A (BTX-A) injections have become a common treatment modality for patients suffering from muscle spasticity. Despite its benefits, BTX-A treatments have been associated with adverse effects on target muscles. Currently, application of BTX-A is largely based on clinical experience, and research quantifying muscle structure following BTX-A treatment has not been performed systematically. The purpose of this study was to evaluate strength, muscle mass, and contractile material six months following a single or repeated (2 and 3) BTX-A injections into the quadriceps femoris of New Zealand white rabbits. Twenty three skeletally mature rabbits were divided into four groups: experimental group rabbits received 1, 2, or 3 injections at intervals of 3 months (1-BTX-A, 2-BTX-A, 3-BTX-A, respectively) while control group rabbits received volume-matched saline injections. Knee extensor strength, quadriceps muscle mass, and quadriceps contractile material of the experimental group rabbits were expressed as a percentage change relative to the control group rabbits. One-way ANOVA was used to determine group differences in outcome measures (α=0.05). Muscle strength and contractile material were significantly reduced in experimental compared to control group rabbits but did not differ between experimental groups. Muscle mass was the same in experimental BTX-A and control group rabbits. We concluded from these results that muscle strength and contractile material do not fully recover within six months of BTX-A treatment. PMID:26087882

  10. Implementation of the international code of practice for dosimetry based on standards of absorbed dose to water at the clinical level: First experiences and comparison with a previously used, NK based protocol

    International Nuclear Information System (INIS)

    060Co beam, seven X ray beams ranging from 4 to 18 MV (TPR20,10 from 0.62 to 0.77) and thirteen electron beams with nominal energies ranging from 6 to 24 MeV(R50 from 2.5 to 9.2 g cm-2). For some electron beams, the reference depths are different for the two protocols, therefore it was necessary to match the results with the help of depth-dose curves measured with semiconductor detectors. Though the differences between depths are in general small, this matching may contribute not negligibly to the overall uncertainty. The results of the comparison in terms of the ratios between Dw as determined with the old (Italian Protocol) and the new (TRS 398) procedure are distributed as follows: the mean ratio for the whole set of data is 0.990 (±0.007, 1 st. dev.). The same parameters for photon and electron beams separately are 0.988 (±0.006) and 0.992 (±0.008) respectively. The results are not in disagreement with IAEA TRS 398, where the ratios of Dw in 60Co beam, determined with the ND,w and the NK formalism, are showed for a large set of chambers: the average value is about 1.01, and the maximum and minimum values are about 1.02 and 1.00 respectively, Dw(ND,w) is at the numerator, whereas in the present work it is at the denominator. The comparison with the above-mentioned data cannot be stressed too much, however. In fact, first of all those data were obtained at the level of standardization laboratories, while the present ones are at the clinical level. Our results are concerning only a few chambers (ESC/87, NE 2581 and NACP) but extend to many different beam qualities

  11. Adaptation of TURN protocol to SIP protocol

    CERN Document Server

    Guezouri, Mustapha; Keche, Mokhtar

    2010-01-01

    Today, SIP is a protocol par Excellence in the field of communication over Internet. But, the fact that it belongs to the application layer constitutes a weakness vis-a-vis the NAT traversal. This weakness is due to the way in which the server replies to the requests of clients on the one hand. On the other, it is caused by the dynamic allocation of UDP ports for emission and reception of packets RTP/RTCP. The TURN Protocol may face this weakness. However, its use requires a certain number of exchanges between the clients and a TURN server before establishing the multimedia sessions and this increase the latent time. In this article, we propose to adapt TURN protocol for applications based on SIP protocol such as telephony over Internet, conference video, etc. This adaptation optimises the establishment of multimedia sessions by integrating a manager of TCP connections and multimedia flow controller into SIP Proxy server.

  12. Blind Collective Signature Protocol

    Directory of Open Access Journals (Sweden)

    Nikolay A. Moldovyan

    2011-06-01

    Full Text Available Using the digital signature (DS scheme specified by Belarusian DS standard there are designed the collective and blind collective DS protocols. Signature formation is performed simultaneously by all of the assigned signers, therefore the proposed protocols can be used also as protocols for simultaneous signing a contract. The proposed blind collective DS protocol represents a particular implementation of the blind multisignature schemes that is a novel type of the signature schemes. The proposed protocols are the first implementations of the multisignature schemes based on Belarusian signature standard.

  13. Efficient decentralized consensus protocols

    Science.gov (United States)

    Lakshman, T. V.; Agrawala, A. K.

    1986-01-01

    Decentralized consensus protocols are characterized by successive rounds of message interchanges. Protocols which achieve a consensus in one round of message interchange require O(N-squared) messages, where N is the number of participants. In this paper, a communication scheme, based on finite projective planes, which requires only O(N sq rt N) messages for each round is presented. Using this communication scheme, decentralized consensus protocols which achieve a consensus within two rounds of message interchange are developed. The protocols are symmetric, and the communication scheme does not impose any hierarchical structure. The scheme is illustrated using blocking and nonblocking commit protocols, decentralized extrema finding, and computation of the sum function.

  14. Influence of sequence protocol variations on MR image texture at 3.0 Tesla : implications for texture-based pattern classification in a clinical setting

    International Nuclear Information System (INIS)

    The purpose of our study project was to (1) investigate the sensitivity of quantitative texture features of different categories to clinically feasible variations of NA (number of acquisitions), TR (repetition time), TE (echo time), and SBW (sampling bandwidth), and the dependence of such sensitivity on the spatial resolution; (2) determine whether MR image interpolation at the pixel or k-space level can enhance textural differences between tissues with physically different patterns; and (3) assess the feasibility of texture analysis for classification of liver cysts and hemangiomas on routine, non-enhanced T1- and T2-weighted MR images, respectively, at 3.0 Tesla. To determine the sensitivities of texture features, as well as the effects of MR image interpolation, we used PSAG (polystyrene spheres and agar gel) phantoms with different sphere sizes, ranging from 0.8 to 3.15 mm, as test objects, and a micro-imaging gradient insert for acquisition of high-resolution, T2-weighted MSME sequences. The results of these experiments clearly show that, although texture features of all categories are increasingly sensitive to acquisition parameter variations with increasing spatial resolution, variations of NA, TR, TE, and SBW have little effect on the results of pattern discrimination, as long as the resolution is sufficiently high. Co-occurrence matrix features are particularly useful for pattern discrimination if datasets are heterogeneous with regard to different acquisition parameters, including spatial resolution. MR image interpolation can improve the results of pattern classification, at least based on texture features derived from the co-occurrence matrix, run-length matrix, or absolute gradient. Unless spatial resolution is very poor, zero-filling is the interpolation technique of choice. For this reason, zero-fill interpolation was used to enhance texture-based pattern classification of liver cysts and hemangiomas using routine, zero-fill interpolated MR images

  15. Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice

    Directory of Open Access Journals (Sweden)

    Peeraer Louis

    2011-03-01

    Full Text Available Abstract Background Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study. Methods The study is designed as a pragmatic randomised clinical trial (RCT with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema. Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100 or a group receiving podiatric treatment (n = 100. Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index. Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using

  16. Dose protocols of acetylcholine test in Chinese

    Institute of Scientific and Technical Information of China (English)

    向定成; 龚志华; 何建新; 洪长江; 邱建; 马骏

    2004-01-01

    @@ Acetylcholine test has been widely used clinically in several countries as a practical test provoking coronary artery spasm.1-3 Although it has also been launched recently in a few hospitals in China, the dose protocol for acetylcholine test used in these hospitals were from abroad.4,5 This study was aimed at developing a dose protocol for acetylcholine test suitable for Chinese people.

  17. The eCALM Trial-eTherapy for cancer appLying mindfulness: online mindfulness-based cancer recovery program for underserved individuals living with cancer in Alberta: protocol development for a randomized wait-list controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Zernicke Kristin A

    2013-02-01

    Full Text Available Abstract Background Elevated stress can exacerbate cancer symptom severity, and after completion of primary cancer treatments, many individuals continue to have significant distress. Mindfulness-Based Cancer Recovery (MBCR is an 8-week group psychosocial intervention consisting of training in mindfulness meditation and yoga designed to mitigate stress, pain, and chronic illness. Efficacy research shows face-to-face (F2F MBCR programs have positive benefits for cancer patients; however barriers exist that impede participation in F2F groups. While online MBCR groups are available to the public, none have been evaluated. Primary objective: determine whether underserved patients are willing to participate in and complete an online MBCR program. Secondary objectives: determine whether online MBCR will mirror previous efficacy findings from F2F MBCR groups on patient-reported outcomes. Method/design The study includes cancer patients in Alberta, exhibiting moderate distress, who do not have access to F2F MBCR. Participants will be randomized to either online MBCR, or waiting for the next available group. An anticipated sample size of 64 participants will complete measures online pre and post treatment or waiting period. Feasibility will be tracked through monitoring numbers eligible and participating through each stage of the protocol. Discussion 47 have completed/completing the intervention. Data suggest it is possible to conduct a randomized waitlist controlled trial of online MBCR to reach underserved cancer survivors. Trial registration Clinical Trials.gov Identifier: NCT01476891

  18. The fitness for the Ageing Brain Study II (FABS II: protocol for a randomized controlled clinical trial evaluating the effect of physical activity on cognitive function in patients with Alzheimer's disease

    Directory of Open Access Journals (Sweden)

    Ames David

    2010-12-01

    Full Text Available Abstract Background Observational studies have documented a potential protective effect of physical exercise in older adults who are at risk for developing Alzheimer's disease. The Fitness for the Ageing Brain II (FABS II study is a multicentre randomized controlled clinical trial (RCT aiming to determine whether physical activity reduces the rate of cognitive decline among individuals with Alzheimer's disease. This paper describes the background, objectives of the study, and an overview of the protocol including design, organization and data collection methods. Methods/Design The study will recruit 230 community-dwelling participants diagnosed with Alzheimer's disease. Participants will be randomly allocated to two treatment groups: usual care group or 24-week home-based program consisting of 150 minutes per week of tailored moderate physical activity. The primary outcome measure of the study is cognitive decline as measured by the change from baseline in the total score on the Alzheimer's disease Assessment Scale-Cognitive section. Secondary outcomes of interest include behavioral and psychological symptoms, quality of life, functional level, carer burden and physical function (strength, balance, endurance, physical activity. Primary endpoints will be measured at six and twelve months following the baseline assessment. Discussion This RCT will contribute evidence regarding the potential benefits of a systematic program of physical activity as an affordable and safe intervention for people with Alzheimer's disease. Further, if successful, physical activity in combination with usual care has the potential to alleviate the symptoms of Alzheimer's disease and improve its management and the quality of life of patients and their carers. Trial Registration Australia New Zealand Clinical Trials Registry ACTRN12609000755235

  19. Block Advertisement Protocol

    OpenAIRE

    Nemirovsky, Danil

    2015-01-01

    Bitcoin, a decentralized cryptocurrency, has attracted a lot of attention from academia, financial service industry and enthusiasts. The trade-off between transaction confirmation throughput and centralization of hash power do not allow Bitcoin to perform at the same level as modern payment systems. Block Advertisement Protocol is proposed as a step to resolve this issue. The protocol allows block mining and block relaying to happen in parallel. The protocol dictates a miner to advertise the ...

  20. Security of RFID protocols

    OpenAIRE

    van Deursen, Ton

    2011-01-01

    Radio-frequency identification (RFID) is a technology that uses radio waves to exchange data between RFID readers and tags. The low manufacturing costs and small size and the lack of need of a power source make RFID tags useful in many applications, but also impose a strong need for secure RFID protocols. The first part of this thesis considers the analysis of untraceability of RFID protocols. We start by designing a formal syntax and semantics for security protocols. We define untraceab...

  1. "Counterfactual" quantum protocols

    OpenAIRE

    Vaidman, Lev

    2016-01-01

    The counterfactuality of recently proposed protocols is analyzed. A definition of `counterfactuality' is offered and it is argued that an interaction-free measurement of the presence of an opaque object can be named `counterfactual', while proposed "counterfactual" measurements of the absence of such objects are not counterfactual. The quantum key distribution protocols which rely only on measurements of the presence of the object are counterfactual, but quantum direct communication protocols...

  2. Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol.

    Science.gov (United States)

    Heatley, Gerald; Sood, Poornima; Goldstein, Daniel; Uriel, Nir; Cleveland, Joseph; Middlebrook, Don; Mehra, Mandeep R

    2016-04-01

    The HeartMate 3 left ventricular assist system (LVAS; St. Jude Medical, Inc., formerly Thoratec Corporation, Pleasanton, CA) was recently introduced into clinical trials for durable circulatory support in patients with medically refractory advanced-stage heart failure. This centrifugal, fully magnetically levitated, continuous-flow pump is engineered with the intent to enhance hemocompatibility and reduce shear stress on blood elements, while also possessing intrinsic pulsatility. Although bridge-to-transplant (BTT) and destination therapy (DT) are established dichotomous indications for durable left ventricular assist device (LVAD) support, clinical practice has challenged the appropriateness of these designations. The introduction of novel LVAD technology allows for the development of clinical trial designs to keep pace with current practices. The prospective, randomized Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) clinical trial aims to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HeartMate II LVAS (also St. Jude Medical, Inc.). The innovative trial design includes patients enrolled under a single inclusion and exclusion criteria , regardless of the intended use of the device, with outcomes ascertained in the short term (ST, at 6 months) and long term (LT, at 2 years). This adaptive trial design includes a pre-specified safety phase (n = 30) analysis. The ST cohort includes the first 294 patients and the LT cohort includes the first 366 patients for evaluation of the composite primary end-point of survival to transplant, recovery or LVAD support free of debilitating stroke (modified Rankin score >3), or re-operation to replace the pump. As part of the adaptive design, an analysis by an independent statistician will determine whether sample size adjustment is required at pre-specified times during the study. A further 662

  3. The diagnosis of urinary tract infections in young children (DUTY: protocol for a diagnostic and prospective observational study to derive and validate a clinical algorithm for the diagnosis of UTI in children presenting to primary care with an acute illness

    Directory of Open Access Journals (Sweden)

    Downing Harriet

    2012-07-01

    Full Text Available Abstract Background Urinary tract infection (UTI is common in children, and may cause serious illness and recurrent symptoms. However, obtaining a urine sample from young children in primary care is challenging and not feasible for large numbers. Evidence regarding the predictive value of symptoms, signs and urinalysis for UTI in young children is urgently needed to help primary care clinicians better identify children who should be investigated for UTI. This paper describes the protocol for the Diagnosis of Urinary Tract infection in Young children (DUTY study. The overall study aim is to derive and validate a cost-effective clinical algorithm for the diagnosis of UTI in children presenting to primary care acutely unwell. Methods/design DUTY is a multicentre, diagnostic and prospective observational study aiming to recruit at least 7,000 children aged before their fifth birthday, being assessed in primary care for any acute, non-traumatic, illness of ≤ 28 days duration. Urine samples will be obtained from eligible consented children, and data collected on medical history and presenting symptoms and signs. Urine samples will be dipstick tested in general practice and sent for microbiological analysis. All children with culture positive urines and a random sample of children with urine culture results in other, non-positive categories will be followed up to record symptom duration and healthcare resource use. A diagnostic algorithm will be constructed and validated and an economic evaluation conducted. The primary outcome will be a validated diagnostic algorithm using a reference standard of a pure/predominant growth of at least >103, but usually >105 CFU/mL of one, but no more than two uropathogens. We will use logistic regression to identify the clinical predictors (i.e. demographic, medical history, presenting signs and symptoms and urine dipstick analysis results most strongly associated with a positive urine culture result. We will

  4. Development of a clinical trial to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lauscher Johannes C

    2012-02-01

    Full Text Available Abstract Background Incisional hernia is a frequent complication in abdominal surgery. This article describes the development of a prospective randomized clinical trial designed to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia. Methods/Design This clinical multicenter trial has been designed to compare watchful waiting and surgical repair for patients with oligosymptomatic incisional hernia. Participants are randomized to watchful waiting or surgery and followed up for two years. The primary efficacy endpoint is pain/discomfort during normal activities as a result of the hernia or hernia repair two years after enrolment, as measured by the hernia-specific Surgical Pain Scales (SPS. The target sample size of six hundred thirty-six patients was calculated to detect non-inferiority of the experimental intervention (watchful waiting in the primary endpoint. Sixteen surgical centers will take part in the study and have submitted their declaration of commitment giving the estimated number of participating patients per year. A three-person data safety monitoring board will meet annually to monitor and supervise the trial. Discussion To date, we could find no published data on the natural course of incisional hernias. To our knowledge, watchful waiting has never been compared to standard surgical repair as a treatment option for incisional hernias. A trial to compare the outcome of the two approaches in patients with oligosymptomatic incisional hernias is urgently needed to provide data that can facilitate the choice between treatment options. If watchful waiting was equal to surgical repair, the high costs of surgical repair could be saved. The design for such a trial is described here. This multicenter trial will be funded by the German Research Foundation (DFG. The ethics committee of the Charité has approved the study protocol. Approval has been obtained from

  5. The perspectives of clinical staff and bereaved informal care-givers on the use of continuous sedation until death for cancer patients: The study protocol of the UNBIASED study

    Directory of Open Access Journals (Sweden)

    van der Heide Agnes

    2011-03-01

    Full Text Available Abstract Background A significant minority of dying people experience refractory symptoms or extreme distress unresponsive to conventional therapies. In such circumstances, sedation may be used to decrease or remove consciousness until death occurs. This practice is described in a variety of ways, including: 'palliative sedation', 'terminal sedation', 'continuous deep sedation until death', 'proportionate sedation' or 'palliative sedation to unconsciousness'. Surveys show large unexplained variation in incidence of sedation at the end of life across countries and care settings and there are ethical concerns about the use, intentions, risks and significance of the practice in palliative care. There are also questions about how to explain international variation in the use of the practice. This protocol relates to the UNBIASED study (UK Netherlands Belgium International Sedation Study, which comprises three linked studies with separate funding sources in the UK, Belgium and the Netherlands. The aims of the study are to explore decision-making surrounding the application of continuous sedation until death in contemporary clinical practice, and to understand the experiences of clinical staff and decedents' informal care-givers of the use of continuous sedation until death and their perceptions of its contribution to the dying process. The UNBIASED study is part of the European Association for Palliative Care Research Network. Methods/Design To realize the study aims, a two-phase study has been designed. The study settings include: the domestic home, hospital and expert palliative care sites. Phase 1 consists of: a focus groups with health care staff and bereaved informal care-givers; and b a preliminary case notes review to study the range of sedation therapy provided at the end of life to cancer patients who died within a 12 week period. Phase 2 employs qualitative methods to develop 30 patient-centred case studies in each country. These involve

  6. Tromboembolismo venoso em cirurgia plástica: protocolo de prevenção na Clínica Ivo Pitanguy Venous thromboembolism in plastic surgery: prevention protocol at Ivo Pitanguy Clinic

    Directory of Open Access Journals (Sweden)

    Rita Azevedo de Paiva

    2010-12-01

    Full Text Available INTRODUÇÃO: A trombose venosa profunda (TVP e o seu desfecho imediato mais grave, o tromboembolismo pulmonar (TEP, são complicações de incidência elevada em pacientes hospitalizados e principalmente naqueles submetidos à cirurgia. OBJETIVO: Apresentar o protocolo de profilaxia de Tromboembolismo (TEV da Clínica Ivo Pitanguy, mostrando a incidência de TEV no Serviço antes e após a introdução deste protocolo, assim como a incidência de hematomas, no período de cinco anos. MÉTODO: Estudo de revisão dos prontuários dos pacientes operados no período de julho de 2004 a maio de 2009. Comparou-se a incidência de eventos trombóticos antes e após a introdução do protocolo, assim como a incidência de hematomas. RESULTADOS: Foram analisados 1700 prontuários. Desde a introdução do protocolo, não ocorreu nenhum caso de tromboembolismo venoso, em 711 pacientes operados. A incidência de hematomas com necessidade de revisão cirúrgica foi reduzida, provavelmente pelo controle pressórico mais rigoroso após a introdução do protocolo. CONCLUSÃO: O protocolo tem se mostrado de utilização simples e efetiva. Houve redução da incidência de TEV e hematomas a partir de sua introdução.BACKGROUND: The deep vein thrombosis (DVT and its most dangerous outcome, the pulmonary embolism (PE, are complications of high incidence in hospitalized patients and in those submitted to surgery. OBJECTIVE: This study presents the guideline to prevention of thromboembolism at Ivo Pitanguy Clinic and its incidence before and after the introduction of this protocol, in a period of five years. We also relate the incidence of hematoma before and after the beginning of the protocol. METHODS: The study consists of the revision of the medical records of all patients operated between July 2004 and May 2009. We compared the incidence of thromboembolic events before and after the beginning of the protocol as well as the incidence of hematomas that were

  7. Commemoration of Montreal Protocol

    OpenAIRE

    CUCULEANU Georgeta

    2008-01-01

    The paper presents the main provisions of the Convention from Vienna for the Protection of the Ozone Layer, the 1987 Montreal Protocol on Substances that deplete the Ozone Layer and its Amendments. The restricting and banning programmes of these substances, some consequences on the environment of the absence of the Protocol and some alternative substances are also presented.

  8. Unconditionally Secure Protocols

    DEFF Research Database (Denmark)

    Meldgaard, Sigurd Torkel

    the bottleneck of sorting networks. And we show how to utilize this construction for four-player MPC. Another line of work has results about the power of correlated randomness; meaning in a preprocessing phase the participants in a MPC protocol receive samples from some joint distribution to aid them implement......This thesis contains research on the theory of secure multi-party computation (MPC). Especially information theoretically (as opposed to computationally) secure protocols. It contains results from two main lines of work. One line on Information Theoretically Secure Oblivious RAMS, and how...... the secure computation. Especially we look at the communication complexity of protocols in this model, and perfectly secure protocols. We show general protocols for any finite functionality with statistical security and optimal communication complexity (but exponential amount of preprocessing). And for two...

  9. NEURAPRO-E study protocol

    DEFF Research Database (Denmark)

    Markulev, Connie; McGorry, Patrick D; Nelson, Barnaby;

    2016-01-01

    response to omega-3 PUFA treatment in the UHR group. CONCLUSION: This is the protocol of the NeuraproE study. Utilizing a large sample, results from this study will be important in informing indicated prevention strategies for schizophrenia and other psychotic disorders, which may be the strongest avenue...... polyunsaturated fatty acids (PUFAs), coupled with the falling transition rate in ultra high-risk (UHR) samples, mean that further study of such benign, potentially neuroprotective interventions is clinically and ethically required. Employing a multicentre approach, enabling a large sample size, this study will...

  10. Protocolized Resuscitation of Burn Patients.

    Science.gov (United States)

    Cancio, Leopoldo C; Salinas, Jose; Kramer, George C

    2016-10-01

    Fluid resuscitation of burn patients is commonly initiated using modified Brooke or Parkland formula. The fluid infusion rate is titrated up or down hourly to maintain adequate urine output and other endpoints. Over-resuscitation leads to morbid complications. Adherence to paper-based protocols, flow sheets, and clinical practice guidelines is associated with decreased fluid resuscitation volumes and complications. Computerized tools assist providers. Although completely autonomous closed-loop control of resuscitation has been demonstrated in animal models of burn shock, the major advantages of open-loop and decision-support systems are identifying trends, enhancing situational awareness, and encouraging burn team communication. PMID:27600131

  11. Statistical principles for prospective study protocols:

    DEFF Research Database (Denmark)

    Christensen, Robin; Langberg, Henning

    2012-01-01

    In the design of scientific studies it is essential to decide on which scientific questions one aims to answer, just as it is important to decide on the correct statistical methods to use to answer these questions. The correct use of statistical methods is crucial in all aspects of research to...... "statistically significant" or not. In the present paper we outline the considerations and suggestions on how to build a trial protocol, with an emphasis on having a rigorous protocol stage, always leading to a full article manuscript, independent of statistical findings. We conclude that authors, who find...... (rigorous) protocol writing too troublesome, will realize that they have already written the first half of the final paper if they follow these recommendations; authors simply need to change the protocols future tense into past tense. Thus, the aim of this clinical commentary is to describe and explain the...

  12. Paediatric B-cell precursor acute lymphoblastic leukaemia with t(1;19)(q23;p13): clinical and cytogenetic characteristics of 47 cases from the Nordic countries treated according to NOPHO protocols.

    Science.gov (United States)

    Andersen, Mette K; Autio, Kirsi; Barbany, Gisela; Borgström, Georg; Cavelier, Lucia; Golovleva, Irina; Heim, Sverre; Heinonen, Kristina; Hovland, Randi; Johannsson, Johann H; Johansson, Bertil; Kjeldsen, Eigil; Nordgren, Ann; Palmqvist, Lars; Forestier, Erik

    2011-10-01

    The translocation t(1;19)(q23;p13)/der(19)t(1;19) is a risk stratifying aberration in childhood B-cell precursor acute lymphoblastic leukaemia (BCP ALL) in the Nordic countries. We have identified 47 children/adolescents with t(1;19)/der(19)t(1;19)-positive BCP ALL treated on two successive Nordic Society of Paediatric Haematology and Oncology (NOPHO) protocols between 1992 and 2007 and have reviewed the clinical and cytogenetic characteristics of these cases, comprising 1·8% of all cases. The translocation was balanced in 15 cases (32%) and unbalanced in 29 cases (62%). The most common additional chromosome abnormalities were del(9p), i(9q), del(6q), and del(13q). The median age was 7 years, the median white blood cell (WBC) count was 16 × 10(9)/l, and the female/male ratio was 1·2. The predicted event-free survival (EFS) at 5 and 10 years was 0·79, whereas the predicted overall survival (OS) at 5 and 10 years was 0·85 and 0·82, respectively. Nine patients had a bone marrow relapse after a median of 23 months; no patient had a central nervous system relapse. Additional cytogenetic abnormalities, age, gender, WBC count or whether the t(1;19) was balanced or unbalanced did not influence EFS or OS. Compared to cases with t(12,21) and high hyperdiploidy, EFS was similar, but overall survival was worse in patients with t(1;19)/der(19)t(1;19) (P = 0·004). PMID:21902680

  13. Protocolo clínico e diretrizes terapêuticas para uso de hidroxiureia na doença falciforme Clinical protocol and therapeutic guidelines for the use of hydroxyurea in sickle cell disease

    Directory of Open Access Journals (Sweden)

    Rodolfo D. Cançado

    2009-01-01

    Full Text Available Hidroxiureia (HU constitui o avanço mais importante no tratamento de pacientes com doença falciforme (DF. Fortes evidências confirmam a eficácia da HU em pacientes adultos diminuindo os episódios de dor intensa, hospitalização, número de transfusões e síndrome torácica aguda. Embora a evidência da eficácia do tratamento com HU em crianças não seja tão forte, os recentes resultados são encorajadores. Os dados atuais em relação aos riscos a curto e longo prazos da terapia com HU em adultos são aceitáveis comparado aos riscos dos pacientes não tratados com HU. Neste artigo, apresentamos revisão detalhada sobre os principais aspectos quanto à eficácia, efetividade, toxicidade e barreiras ao uso de HU em pacientes com DF e propomos um protocolo clínico e diretrizes terapêuticas para o uso de HU em pacientes com DF.Hydroxyurea (HU is an important major advance in the treatment of sickle cell disease (SCD. Strong evidence supports the effectiveness of HU in adults; severe painful episodes, hospitalizations, number of blood transfusions, and acute chest syndrome are reduced. Although the evidence of its effectiveness in the treatment of children is not as strong, the emerging data is encouraging. Current data on the risks of both short- and long-term HU therapy in adults are acceptable when compared to the risks of untreated SCD. In this article, we present a detailed review of the main aspects of the efficacy, effectiveness, toxicity, and barriers to the use of HU for SCD and propose a clinical protocol and therapeutic guidelines for the use of HU in patients with SCD.

  14. IPv6 Protocol Analyzer

    Institute of Scientific and Technical Information of China (English)

    2002-01-01

    With the emerging of next generation Intemet protocol (IPv6), it is expected to replace the current version of Internet protocol (IPv4) that will be exhausted in the near future. Besides providing adequate address space, some other new features are included into the new 128 bits of IP such as IP auto configuration, quality of service, simple routing capability, security, mobility and multicasting. The current protocol analyzer will not be able to handle IPv6 packets. This paper will focus on developing protocol analyzer that decodes IPv6 packet. IPv6 protocol analyzer is an application module,which is able to decode the IPv6 packet and provide detail breakdown of the construction of the packet. It has to understand the detail construction of the IPv6, and provide a high level abstraction of bits and bytes of the IPv6 packet.Thus it increases network administrators' understanding of a network protocol,helps he/she in solving protocol related problem in a IPv6 network environment.

  15. ATM and Internet protocol

    CERN Document Server

    Bentall, M; Turton, B

    1998-01-01

    Asynchronous Transfer Mode (ATM) is a protocol that allows data, sound and video being transferred between independent networks via ISDN links to be supplied to, and interpreted by, the various system protocols.ATM and Internet Protocol explains the working of the ATM and B-ISDN network for readers with a basic understanding of telecommunications. It provides a handy reference to everyone working with ATM who may not require the full standards in detail, but need a comprehensive guide to ATM. A substantial section is devoted to the problems of running IP over ATM and there is some discussion o

  16. Playing With Population Protocols

    Directory of Open Access Journals (Sweden)

    Xavier Koegler

    2009-06-01

    Full Text Available Population protocols have been introduced as a model of sensor networks consisting of very limited mobile agents with no control over their own movement: A collection of anonymous agents, modeled by finite automata, interact in pairs according to some rules. Predicates on the initial configurations that can be computed by such protocols have been characterized under several hypotheses. We discuss here whether and when the rules of interactions between agents can be seen as a game from game theory. We do so by discussing several basic protocols.

  17. Linear Logical Voting Protocols

    DEFF Research Database (Denmark)

    DeYoung, Henry; Schürmann, Carsten

    2012-01-01

    Current approaches to electronic implementations of voting protocols involve translating legal text to source code of an imperative programming language. Because the gap between legal text and source code is very large, it is difficult to trust that the program meets its legal specification....... In response, we promote linear logic as a high-level language for both specifying and implementing voting protocols. Our linear logical specifications of the single-winner first-past-the-post (SW- FPTP) and single transferable vote (STV) protocols demonstrate that this approach leads to concise...

  18. 1996 : Track Count Protocol

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The goal of St. Vincent National Wildlife Refuge's Track Count Protocol is to provide an index to the population size of game animals inhabiting St. Vincent Island.

  19. Village Level Protocol

    OpenAIRE

    Ankur Dumka

    2014-01-01

    Here in this paper we have proposed for a protocol to be implemented at the village level. As at the village level as there are few agencies to be contacted at village level so this uses a local label addressing of 4 bits to support 16 agencies with 3 bits Time to live header which checks weather a packet is reached or not. Thus being small packet size this protocol is faster and able to support fast network service at village level.

  20. USA-USSR protocol

    CERN Multimedia

    1970-01-01

    On 30 November the USA Atomic Energy Commission and the USSR State Committee for the Utilization of Atomic Energy signed, in Washington, a protocol 'on carrying out of joint projects in the field of high energy physics at the accelerators of the National Accelerator Laboratory (Batavia) and the Institute for High Energy Physics (Serpukhov)'. The protocol will be in force for five years and can be extended by mutual agreement.

  1. An auditable protocol for treating attention deficit/hyperactivity disorder

    OpenAIRE

    Hill, P; Taylor, E.

    2001-01-01

    We present an auditable protocol for attention deficit/hyperactivity disorder (ADHD) or hyperkinetic disorder. The protocol is derived from standard recommendations and evidence, and is intended for outpatient medical clinic practice in secondary care. Suggested side effect rating scales are included.



  2. SPECT/CT workflow and imaging protocols

    International Nuclear Information System (INIS)

    Introducing a hybrid imaging method such as single photon emission computed tomography (SPECT)/CT greatly alters the routine in the nuclear medicine department. It requires designing new workflow processes and the revision of original scheduling process and imaging protocols. In addition, the imaging protocol should be adapted for each individual patient, so that performing CT is fully justified and the CT procedure is fully tailored to address the clinical issue. Such refinements often occur before the procedure is started but may be required at some intermediate stage of the procedure. Furthermore, SPECT/CT leads in many instances to a new partnership with the radiology department. This article presents practical advice and highlights the key clinical elements which need to be considered to help understand the workflow process of SPECT/CT and optimise imaging protocols. The workflow process using SPECT/CT is complex in particular because of its bimodal character, the large spectrum of stakeholders, the multiplicity of their activities at various time points and the need for real-time decision-making. With help from analytical tools developed for quality assessment, the workflow process using SPECT/CT may be separated into related, but independent steps, each with its specific human and material resources to use as inputs or outputs. This helps identify factors that could contribute to failure in routine clinical practice. At each step of the process, practical aspects to optimise imaging procedure and protocols are developed. A decision-making algorithm for justifying each CT indication as well as the appropriateness of each CT protocol is the cornerstone of routine clinical practice using SPECT/CT. In conclusion, implementing hybrid SPECT/CT imaging requires new ways of working. It is highly rewarding from a clinical perspective, but it also proves to be a daily challenge in terms of management. (orig.)

  3. Effects of tailored neck-shoulder pain treatment based on a decision model guided by clinical assessments and standardized functional tests. A study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Björklund Martin

    2012-05-01

    Full Text Available Abstract Background A major problem with rehabilitation interventions for neck pain is that the condition may have multiple causes, thus a single treatment approach is seldom efficient. The present study protocol outlines a single blinded randomised controlled trial evaluating the effect of tailored treatment for neck-shoulder pain. The treatment is based on a decision model guided by standardized clinical assessment and functional tests with cut-off values. Our main hypothesis is that the tailored treatment has better short, intermediate and long-term effects than either non-tailored treatment or treatment-as-usual (TAU on pain and function. We sub-sequentially hypothesize that tailored and non-tailored treatment both have better effect than TAU. Methods/Design 120 working women with minimum six weeks of nonspecific neck-shoulder pain aged 20–65, are allocated by minimisation with the factors age, duration of pain, pain intensity and disability in to the groups tailored treatment (T, non-tailored treatment (NT or treatment-as-usual (TAU. Treatment is given to the groups T and NT for 11 weeks (27 sessions evenly distributed. An extensive presentation of the tests and treatment decision model is provided. The main treatment components are manual therapy, cranio-cervical flexion exercise and strength training, EMG-biofeedback training, treatment for cervicogenic headache, neck motor control training. A decision algorithm based on the baseline assessment determines the treatment components given to each participant of T- and NT-groups. Primary outcome measures are physical functioning (Neck Disability Index and average pain intensity last week (Numeric Rating Scale. Secondary outcomes are general improvement (Patient Global Impression of Change scale, symptoms (Profile Fitness Mapping neck questionnaire, capacity to work in the last 6 weeks (quality and quantity and pressure pain threshold of m. trapezius. Primary and secondary outcomes will

  4. Debunking myths of protocol registration

    OpenAIRE

    Chang Stephanie M; Slutsky Jean

    2012-01-01

    Abstract Developing and registering protocols may seem like an added burden to systematic review investigators. This paper discusses benefits of protocol registration and debunks common misperceptions on the barriers of protocol registration. Protocol registration is easy to do, reduces duplication of effort and benefits the review team by preventing later confusion.

  5. DNA repair protocols

    DEFF Research Database (Denmark)

    Bjergbæk, Lotte

    In its 3rd edition, this Methods in Molecular Biology(TM) book covers the eukaryotic response to genomic insult including advanced protocols and standard techniques in the field of DNA repair. Offers expert guidance for DNA repair, recombination, and replication. Current knowledge of the mechanisms...... that regulate DNA repair has grown significantly over the past years with technology advances such as RNA interference, advanced proteomics and microscopy as well as high throughput screens. The third edition of DNA Repair Protocols covers various aspects of the eukaryotic response to genomic insult including...... recent advanced protocols as well as standard techniques used in the field of DNA repair. Both mammalian and non-mammalian model organisms are covered in the book, and many of the techniques can be applied with only minor modifications to other systems than the one described. Written in the highly...

  6. Vertical Protocol Composition

    DEFF Research Database (Denmark)

    Groß, Thomas; Mödersheim, Sebastian Alexander

    2011-01-01

    composition, and it is truly commonplace in today’s communication with the diversity of VPNs and secure browser sessions. In fact, it is normal that we have several layers of secure channels: For instance, on top of a VPN-connection, a browser may establish another secure channel (possibly with a different...... end point). Even using the same protocol several times in such a stack of channels is not unusual: An application may very well establish another TLS channel over an established one. We call this selfcomposition. In fact, there is nothing that tells us that all these compositions are sound, i.e., that...... the combination cannot introduce attacks that the individual protocols in isolation do not have. In this work, we prove a composability result in the symbolic model that allows for arbitrary vertical composition (including self-composition). It holds for protocols from any suite of channel and...

  7. 垂体降调节方案的比较%Comparison between different pituitary down-regulation protocols

    Institute of Scientific and Technical Information of China (English)

    黄孙兴; 周灿权

    2012-01-01

    Pituitary down-regulation plays an important role in the development of assisted reproductive technology. It significantly improves the outcome of in vitro fertilization (IVF) and promotes relevant basic research in reproductive physiology. Since the emergence of this technique, many studies have been done to investigate the clinic effect of the different protocols. It took more than 20 years to identify some optimal protocols with the GnRH analogues in IVF, including long protocol, short protocol and GnRH antagonist protocol. Comparison of the difference among these classic protocols can provide theoretical basis for establishing the individual down-regulation protocol, as well as relevant clinical experience.

  8. Security Protocols in a Nutshell

    OpenAIRE

    Toorani, Mohsen

    2016-01-01

    Security protocols are building blocks in secure communications. They deploy some security mechanisms to provide certain security services. Security protocols are considered abstract when analyzed, but they can have extra vulnerabilities when implemented. This manuscript provides a holistic study on security protocols. It reviews foundations of security protocols, taxonomy of attacks on security protocols and their implementations, and different methods and models for security analysis of pro...

  9. Business protocol in integrated Europe

    OpenAIRE

    Pavelová, Nina

    2009-01-01

    The first chapter devotes to definitions of basic terms such as protocol or business protocol, to differences between protocol and etiquette, and between social etiquette and business etiquette. The second chapter focuses on the factors influencing the European business protocol. The third chapter is devoted to the etiquette of business protocol in the European countries. It touches the topics such as punctuality and planning of business appointment, greeting, business cards, dress and appear...

  10. Impersonation Attack on EKE Protocol

    OpenAIRE

    Shirisha Tallapally

    2010-01-01

    The key exchange protocol is one of the most elegant ways of establishing secure communication between pair of users by using a session key. The passwords are of low entropy, hence the protocol should resist all types of password guessing attacks. Recently ECC-3PEKE protocol has been proposed by Chang and Chang. They claimed the protocol is secure, efficient and practical. Unless their claims Yoon and Yoo presented an Undetectable online password guessing attack on the above protocol. A key r...

  11. Security Protocol Design: A Case Study Using Key Distribution Protocols

    Directory of Open Access Journals (Sweden)

    Reiner Dojen

    2009-10-01

    Full Text Available Nowadays security protocols are a key component in providing security services for fixed and mobile networks. These services include data confidentiality, radio link encryption, message integrity, mobile subscriber authentication, electronic payment, certified e-mail, contract signing and nonrepudiation. This paper is concerned with design of effective security protocols. Security protocols are introduced and some common attacks against security protocols are discussed. The vulnerabilities that lead to theattacks are analyzed and guidelines for effective security protocol design are proposed. The presented guidelines are applied to the Andrew Secure RPC protocol and its adapted versions. It is demonstrated that compliance with the guidelines successfully avoidsfreshness and parallel session attacks.

  12. Fetal MRI: techniques and protocols

    International Nuclear Information System (INIS)

    The development of ultrafast sequences has led to a significant improvement in fetal MRI. Imaging protocols have to be adjusted to the rapidly developing fetal central nervous system (CNS) and to the clinical question. Sequence parameters must be changed to cope with the respective developmental stage, to produce images free from motion artefacts and to provide optimum visualization of the region and focus of interest. In contrast to postnatal studies, every suspect fetal CNS abnormality requires examination of the whole fetus and the extrafetal intrauterine structures including the uterus. This approach covers both aspects of fetal CNS disorders: isolated and complex malformations and cerebral lesions arising from the impaired integrity of the feto-placental unit. (orig.)

  13. Fetal MRI: techniques and protocols

    Energy Technology Data Exchange (ETDEWEB)

    Prayer, Daniela [Department of Neuroradiology, University Clinics of Radiodiagnostics, Medical University Vienna, Waehringerguertel 18-10, 1090, Vienna (Austria); Brugger, Peter Christian [Department of Anatomy, Integrative Morphology Group, Medical University Vienna (Austria); Prayer, Lucas [Diagnosezentrum Urania, Vienna (Austria)

    2004-09-01

    The development of ultrafast sequences has led to a significant improvement in fetal MRI. Imaging protocols have to be adjusted to the rapidly developing fetal central nervous system (CNS) and to the clinical question. Sequence parameters must be changed to cope with the respective developmental stage, to produce images free from motion artefacts and to provide optimum visualization of the region and focus of interest. In contrast to postnatal studies, every suspect fetal CNS abnormality requires examination of the whole fetus and the extrafetal intrauterine structures including the uterus. This approach covers both aspects of fetal CNS disorders: isolated and complex malformations and cerebral lesions arising from the impaired integrity of the feto-placental unit. (orig.)

  14. Treatment of bipolar disorder in the Netherlands and concordance with treatment guidelines : study protocol of an observational, longitudinal study on naturalistic treatment of bipolar disorder in everyday clinical practice

    NARCIS (Netherlands)

    Renes, Joannes W.; Regeer, Eline J.; van der Voort, Trijntje Y. G.; Nolen, Willem A.; Kupka, Ralph W.

    2014-01-01

    Background: While various guidelines on the treatment of bipolar disorder have been published over the last decades, adherence to guidelines has been reported to be low. In this article we describe the protocol of a nationwide, multicenter, longitudinal, non-intervention study on the treatment of bi

  15. Model Additional Protocol

    International Nuclear Information System (INIS)

    Since the end of the cold war a series of events has changed the circumstances and requirements of the safeguards system. The discovery of a clandestine nuclear weapons program in Iraq, the continuing difficulty in verifying the initial report of Democratic People's Republic of Korea upon entry into force of their safeguards agreement, and the decision of the South African Government to give up its nuclear weapons program and join the Treaty on the Non-Proliferation of Nuclear Weapons have all played a role in an ambitious effort by IAEA Member States and the Secretariat to strengthen the safeguards system. A major milestone in this effort was reached in May 1997 when the IAEA Board of Governors approved a Model Protocol Additional to Safeguards Agreements. The Model Additional Protocol was negotiated over a period of less than a year by an open-ended committee of the Board involving some 70 Member States and two regional inspectorates. The IAEA is now in the process of negotiating additional protocols, State by State, and implementing them. These additional protocols will provide the IAEA with rights of access to information about all activities related to the use of nuclear material in States with comprehensive safeguards agreements and greatly expanded physical access for IAEA inspectors to confirm or verify this information. In conjunction with this, the IAEA is working on the integration of these measures with those provided for in comprehensive safeguards agreements, with a view to maximizing the effectiveness and efficiency, within available resources, the implementation of safeguards. Details concerning the Model Additional Protocol are given. (author)

  16. The studsvik BNCT project: structure and the proposed protocols

    International Nuclear Information System (INIS)

    The BNCT facility at Studsvik is now ready for clinical trials. Scientific operations of the Studsvik BNCT project are overseen by the Scientific Advisory Board comprised of representatives of all major universities in Sweden. Furthermore, special task groups for clinical and preclinical studies have been formed to facilitate collaboration with academia and to assure the quality of the research. Proposed clinical Phase II trials for glioblastoma are sponsored by the Swedish National Neuro-Oncology Group and, initially, will involve two protocols: Protocol no.1. BNCT for glioblastoma patients who have not received any therapy other than surgery (including stereotactic biopsy only). Protocol no.2. BNCT as a palliative treatment for patients with recurrent glioblastoma following conventional therapies or BNCT. In both protocols, BPA, administered by a 6 hour i.v. infusion, will be used as the boron delivery agent. (author)

  17. Double tracer / double isotope gives Ga-68 dota-noc and F-18 FDG PET / CT. Protocol 1 day in a child with neuroblastoma to determine the clinical state and tumor metabolic state

    International Nuclear Information System (INIS)

    We report on a 6-year-old carrier of a neuroblastoma. The tumor was diagnosed in March 2004, under the right adrenal gland and confirmed by FNAB, ultrasound, CT and tumor markers. Because of its size and extent of the tumor was inoperable at the time due to which was subject to two cycles of chemotherapy (vincristine, cisplatin, etoposide and cyclophosphamide alternating with vincristine, carboplatin, etoposide and cyclophosphamide). After these two cycles of chemotherapy the patient underwent retroperitoneal surgery getting totally dry right adrenal gland and tumor. After surgery the patient received four additional cycles of chemotherapy until March 2005. During the months of August and September 2005 the patient complained of abdominal pain and were suspected of recurrence. She received ultrasound and CT scan were not conclusive. In December 2005 he made a scan with I-131-MIBG (148 MBq, 4 mCi intravenous, is flat and SPECT imaging performed 24 hours to 6 days after injection) showing only the normal left adrenal gland but not recurrence was visualized, which showed that the tumor did not grasp MIBG. In January 2006 the boy (121 cm.'s Height, weight 21 kg) was referred to the Centre for PET / CT of the Bad Berka Central Clinic in Germany for a PET / CT using Ga-68/DOTA- receptor NOC, a high affinity analogue of somatostatin. The tumor marker NSE was determined in serum before the PET / CT whose outcome was high (24.8 ng / ml, cutoff 15). The patient received 46 MBq (1.24 mCi) of Ga-68 DOTA-NOC intravenous and PET / CT whole body was performed at 75 minutes post-injection. No abnormal uptake was observed which indicated that the appellants had no somatostatin receptors. By having this negative result was decided to perform an additional PET / CT with F-18 FDG (with a low dose of contrast to improve the TAC). After fasting for 6 hours, the patient received 151 MBq (4.1 mCi) of F-18 FDG. A PET / CT whole body was performed at 75 minutes after administration of

  18. A family of quantum protocols

    CERN Document Server

    Devetak, I; Winter, A

    2003-01-01

    We introduce two dual, purely quantum protocols: for entanglement distillation assisted by quantum communication (``mother'' protocol) and for entanglement assisted quantum communication (``father'' protocol). We show how a large class of ``children'' protocols (including many previously known ones) can be derived from the two by direct application of teleportation or super-dense coding. Furthermore, the parent may be recovered from most of the children protocols by making them ``coherent''. We also summarize the various resource trade-offs these protocols give rise to.

  19. Effective dose comparison between protocols stitched and usual protocols in dental cone beam CT for complete arcade

    Energy Technology Data Exchange (ETDEWEB)

    Soares, M. R.; Maia, A. F. [Universidade Federal de Sergipe, Departamento de Fisica, Cidade Universitaria Prof. Jose Aloisio de Campos, Marechal Rondon s/n, Jardim Rosa Elze, 49-100000 Sao Cristovao, Sergipe (Brazil); Batista, W. O. G. [Instituto Federal da Bahia, Rua Emidio dos Santos s/n, Barbalho, Salvador, 40301015 Bahia (Brazil); Lara, P. A., E-mail: wilsonottobatista@gmail.com [Instituto de Pesquisas Energeticas e Nucleares / CNEN, Av. Lineu Prestes 2242, Cidade Universitaria, 05508-000 Sao Paulo (Brazil)

    2014-08-15

    To visualization a complete dental radiology dental lives together with two separate proposals: [1] protocols diameter encompassing the entire arch (single) or [2] protocol with multiple fields of view (Fov) which together encompass the entire arch (stitched Fov s). The objective of this study is to evaluate effective dose values in examination protocols for all dental arcade available in different outfits with these two options. For this, a female anthropomorphic phantom manufactured by Radiology Support Devices twenty six thermoluminescent dosimeters inserted in relevant bodies and positions was used. Irradiate the simulator in the clinical conditions. The protocols were averaged and compared: [a] 14.0 cm x 8.5 cm and [b] 8.5 cm x 8.5 cm (Gendex Tomography GXCB 500), [c] protocol stitched for jaw combination of three volumes of 5.0 cm x 3.7 cm (Kodak 9000 3D scanner) [d] protocol stitched Fov s 5.0 cm x 8.0 cm (Planmeca Pro Max 3D) and [e] single technical Fov 14 cm x 8 cm (i-CAT Classical). Our results for the effective dose were: a range between 43.1 and 111.1 micro Sv for technical single Fov and 44.5 and 236.2 for technical stitched Fov s. The protocol presented the highest estimated effective dose was [d] and showed that lowest index was registered [a]. These results demonstrate that the protocol stitched Fov generated in Kodak 9000 3D machine applied the upper dental arch has practically equal value effective dose obtained by protocol extended diameter of, [a], which evaluates in a single image upper and lower arcade. It also demonstrates that the protocol [d] gives an estimate of five times higher than the protocol [a]. Thus, we conclude that in practical terms the protocol [c] stitched Fov s, not presents dosimetric advantages over other protocols. (Author)

  20. Effective dose comparison between protocols stitched and usual protocols in dental cone beam CT for complete arcade

    International Nuclear Information System (INIS)

    To visualization a complete dental radiology dental lives together with two separate proposals: [1] protocols diameter encompassing the entire arch (single) or [2] protocol with multiple fields of view (Fov) which together encompass the entire arch (stitched Fov s). The objective of this study is to evaluate effective dose values in examination protocols for all dental arcade available in different outfits with these two options. For this, a female anthropomorphic phantom manufactured by Radiology Support Devices twenty six thermoluminescent dosimeters inserted in relevant bodies and positions was used. Irradiate the simulator in the clinical conditions. The protocols were averaged and compared: [a] 14.0 cm x 8.5 cm and [b] 8.5 cm x 8.5 cm (Gendex Tomography GXCB 500), [c] protocol stitched for jaw combination of three volumes of 5.0 cm x 3.7 cm (Kodak 9000 3D scanner) [d] protocol stitched Fov s 5.0 cm x 8.0 cm (Planmeca Pro Max 3D) and [e] single technical Fov 14 cm x 8 cm (i-CAT Classical). Our results for the effective dose were: a range between 43.1 and 111.1 micro Sv for technical single Fov and 44.5 and 236.2 for technical stitched Fov s. The protocol presented the highest estimated effective dose was [d] and showed that lowest index was registered [a]. These results demonstrate that the protocol stitched Fov generated in Kodak 9000 3D machine applied the upper dental arch has practically equal value effective dose obtained by protocol extended diameter of, [a], which evaluates in a single image upper and lower arcade. It also demonstrates that the protocol [d] gives an estimate of five times higher than the protocol [a]. Thus, we conclude that in practical terms the protocol [c] stitched Fov s, not presents dosimetric advantages over other protocols. (Author)

  1. Phototherapy Modalities and Protocols

    Directory of Open Access Journals (Sweden)

    Ayten Ferahbaş

    2010-12-01

    Full Text Available Over the past few years, the development of irradiation devices with new emission spectra has led to an expanded role for phototherapy in the treatment of skin diseases. This development is best illustrated by the increasing frequency with which 311 nm UVB phototherapy is used for the treatment of psoriasis and vitiligo, especially. Another example is UVA1 340-400 nm. UVA1 was first used to treat patients with atopic dermatitis, but it has been found to be efficacious in several other skin diseases. This is overview of the protocols for phototherapy with UV in the treatment of skin diseases as currently used according to recent literature review. There are, of course, other protocols in use that are effective.

  2. Symmetric cryptographic protocols

    CERN Document Server

    Ramkumar, Mahalingam

    2014-01-01

    This book focuses on protocols and constructions that make good use of symmetric pseudo random functions (PRF) like block ciphers and hash functions - the building blocks for symmetric cryptography. Readers will benefit from detailed discussion of several strategies for utilizing symmetric PRFs. Coverage includes various key distribution strategies for unicast, broadcast and multicast security, and strategies for constructing efficient digests of dynamic databases using binary hash trees.   •        Provides detailed coverage of symmetric key protocols •        Describes various applications of symmetric building blocks •        Includes strategies for constructing compact and efficient digests of dynamic databases

  3. Clinical outcomes and neural correlates of 20 sessions of repetitive transcranial magnetic stimulation in severe and enduring anorexia nervosa (the TIARA study): study protocol for a randomised controlled feasibility trial

    OpenAIRE

    Bartholdy, Savani; McClelland, Jessica Kate; Kekic, Maria; O'Daly, Owen; Campbell, Iain Cameron; Werthmann, Jessica; Rennalls, Samantha Jayne; Rubia, Katya; David, Anthony Sion; Glennon, Danielle; Kern, Nikola; Schmidt, Ulrike Hermine

    2015-01-01

    Background Anorexia nervosa (AN) is a serious mental disorder with multiple comorbidities and complications. In those with a severe and enduring form of the illness (SEED-AN), treatment responsivity is poor and the evidence base limited. Thus, there is a need for novel treatment strategies. This paper describes the theoretical background and protocol of a feasibility randomised controlled trial (RCT) of real versus sham (placebo) therapeutic repetitive transcranial magnetic stimulation (rTMS)...

  4. Renal scintigraphy in the 21st Century 99m Tc-MAG3 with zero time injection of furosemide (MAG3-F0): a fast and easy protocol, one for all indications. Part 3. Clinical experience. Congenital disorders

    International Nuclear Information System (INIS)

    In this work the Protocol for MAG3-F0 is presented. Patient preparation, easy (only restriction, oral hydration, no bladder cathartic). Dynamic study (iv 1-10 mCi MAG3 + 40-80 mg LASIX), simultaneous injection of furosemide: MAG3-F0, duration of the study: 25 minutes. Tomography-SPECT (20 mCi MAG3). No diuretic needed, duration of the study: 4 minutes. (Author)

  5. Clinical protocol for lumbar disc herniation combined with herniated disc resorption%伴有"自溶"现象的腰椎椎间盘突出症的治疗探讨

    Institute of Scientific and Technical Information of China (English)

    顾庆国; 王新伟; 姜东杰; 王占超; 陈宇; 陈德玉; 袁文

    2013-01-01

    目的 探讨对伴有"自溶"现象的腰椎椎间盘突出症的治疗策略.方法 回顾2006年1月~2011年12月本院收治的腰椎椎间盘突出症患者34例,所有患者比较首次发病与入院前腰椎MRI检查发现均有突出椎间盘缩小的影像学表现.对其中15例行腰后路减压椎间植骨内固定术或髓核摘除术;19例采用卧床休息、腰围固定以及脱水、消炎镇痛等非手术治疗.采用Oswestry功能障碍指数(Oswestry disability index,ODI)、疼痛视觉模拟量表(visual analogue scale,VAS)评分及影像学检查评价治疗效果.结果 手术组15例,手术切口均一期愈合,随访2~16个月,平均12.3个月.术前ODI为42.8±4.25,末次随访时为12.5±1.26,与术前比较差异有统计学意义(P<0.01).VAS评分术前为7.13±1.24分,末次随访时为1.45±0.86分,与术前比较差异有统计学意义(P<0.01).非手术治疗组19例,治疗前ODI为27.9±3.61,末次随访时为10.5±6.4,治疗6个月后复查腰椎MRI平扫提示突出椎间盘完全消失者4例,部分消失者9例,无明显变化者6例.结论 对于伴有"自溶"现象的腰椎椎间盘突出症患者应根据影像学及临床表现采用相应的治疗方法,可获得较满意的临床疗效.%Objective To discuss the clinical protocol for lumbar disc herniation combined with herniated disc resorption. Methods From November 2006 to December 2011, 34 patients suffering from lumbar disc herniation ( LDH ) combined with spontaneous regression of herniated disc were reviewed. These patients were classified into surgical treatment group and conservative treatment group according to the progression of patient' s symptoms before treatment. The Oswestry disability index ( ODI ) and visual analogue scale ( VAS ) score were used to assess the outcome of treatment. Results The DOI of 15 patients in surgical treatment group improved from 42.8 ±4.25 to 12.5 ± 1.26 at the final follow-up( P <0.01 ), and the VAS scores decreased from 7

  6. Protocols for Microcontrollers Networks

    OpenAIRE

    López, Ricardo A.

    2011-01-01

    The microcontrollers are embedded in our way of life and are found in many devices. The ability of Very High Scale Integration (VLSI) - with almost exponential growth in recent years makes these devices every day contain functions previously unthinkable. Therefore, a grouping of these networked devices creates a very powerful system, which equipped with a standard protocol that allows interconnection to the Internet gives you a virtually unlimited range of scalability. For these reasons, t...

  7. Seismic protocol urges sensitivity

    International Nuclear Information System (INIS)

    This paper is a preliminary summary of a protocol manual for conducting seismic surveys in various topographic and geographic situations to minimize environmental impacts. The manual aims at addressing unique issues for six different types of ecological environments in such a way as to enhance contractors' overall awareness of the types of environmental issues they may encounter, along with some common sense methods of dealing with them. Those six environments are marine, coastal, rain forest, arctic, semi-level terrains, and mountainous

  8. An automatic protocol composition checker

    OpenAIRE

    Kojovic, Ivana

    2012-01-01

    Formal analysis is widely used to prove security properties of the protocols. There are tools to check protocols in isolation, but in fact we use many protocols in parallel or even vertically stacked, e.g. running an application protocol (like login) over a secure channel (like TLS) and in general it is unclear if that is safe. There are several works that give sufficient conditions for parallel and vertical composition, but there exists no program to check whether these conditions are actual...

  9. Clinical trials of CCLSG L874 and I874 protocols without cranial irradiation for standard-risk acute lymphoblastic leukemia in childhood; A study from the children's cancer and leukemia study group

    Energy Technology Data Exchange (ETDEWEB)

    Koizumi, Shoichi (Kanazawa Univ. (Japan). School of Medicine); Fujimoto, Takeo; Tsurusawa, Masahito (and others)

    1992-10-01

    In the CCLSG-874 protocol for children with low-risk (LR) and intermediate-risk (IR) acute lymphoblastic leukemia (ALL), two regimens with or without cranial irradiation (CI) were compared with respect to their ability to prevent central nervous system (CNS) leukemia and to improve overall outcome of ALL. From 1987 to 1990, 82 and 109 evaluable patients were registered into L874 and I874 protocols for LR and IR patients, respectively. All responders to induction therapy were randomized to treatment with 18 Gy of CI plus intrathecal methotrexate (MTX it) or to treatment with high-dose MTX plus MTX it. Patients were then treated with standard maintenance regimens of L874 and I874. At a median follow-up of 39 months (range 14-58 months) there was no difference in the rate of hematologic relapse between the CI group and MTX group. The rate of CNS relapse in the MTX group seemed to be higher (3 of 39 in L874 and 2 of 54 in I874) than that in the CI group (1 of 43 in L874 and 0 of 55 in I874), but these data were not statistically significant. The rates of 4-year event-free survival (EFS) in L874 were 81.1[+-]7.6% (mean[+-]SE) and 75.2[+-]7.9% (ns) for the CI and MTX group, respectively, and the rates of EFS in I874 were 70.0[+-]13.6% and 70.0[+-]9.0% (ns) for the CI and MTX group, respectively. These data suggest that MTX alone may be as effective as CI to prolong disease-free survival in LR and IR ALL although further continuous studies are needed. Analysis of serial CCLSG protocols for ALL from 1981 revealed that the rate of EFS of ALL allover including all risk groups has gradually been increasing from 44.2[+-]3.6% for 811 protocol and 53.1[+-]3.5% for 841 to 65.5[+-]3.6% for the present 874 protocol. (author).

  10. Dose-related effects of vitamin D on immune responses in patients with clinically isolated syndrome and healthy control participants: study protocol for an exploratory randomized double- blind placebo-controlled trial.

    LENUS (Irish Health Repository)

    O'Connell, Karen

    2013-08-01

    There is increasing evidence linking vitamin D deficiency to both susceptibility to, and severity of, multiple sclerosis (MS). Patients with the clinically isolated syndrome represent the initial presentation of a demyelinating disorder, and those with asymptomatic lesions on magnetic resonance imaging (MRI) are at risk of progression to clinically definite MS. The aims of this study are to examine the immunologic effects of vitamin D in both healthy individuals and in patients with clinically isolated syndrome, and in the latter group the effects on disease progression assessed by MRI and clinical measures.

  11. Predictive factors of ovarian response and clinical outcome after IVF/ICSI following a rFSH/GnRH antagonist protocol with or without oral contraceptive pre-treatment

    DEFF Research Database (Denmark)

    Andersen, A Nyboe; Witjes, H; Gordon, K;

    2011-01-01

    Prediction of ovarian response prior to the first controlled ovarian stimulation (COS) cycle is useful in determining the optimal starting dose of recombinant FSH (rFSH). However, potentially predictive factors may be subject to inter-cycle variability and many patients are pre-treated with oral...... contraceptives (OC) for scheduling purposes. Our objective was to determine predictive factors of ovarian response for patients undergoing COS with rFSH in a gonadotrophin-releasing hormone antagonist protocol and to determine the inter-cycle variability of these factors....

  12. FRENCH PROTOCOL CARDS

    CERN Multimedia

    Human Resources Division

    2000-01-01

    Senior officials, holders of FRENCH PROTOCOL cards (blue cards) due to expire on 31.12.2000, are requested to return these cards and those of family members, for extension to: Bureau des cartes, Bât 33.1-009/1-015 Should the three spaces for authentication on the back of the card be full, please enclose two passport photographs for a new card. In the case of children aged 14 and over, an attestation of dependency and a school certificate should be returned with the card.

  13. FRENCH PROTOCOL CARDS

    CERN Multimedia

    Division du Personnel

    1999-01-01

    Senior officials, holders of FRENCH PROTOCOL cards (blue cards) due to expire on 31.12.1999, are requested to return these cards and those of family members, for extension to:Bureau des cartes, bâtiment 33.1-025Should the 3 spaces for authentication on the back of the card be full, please enclose 2 passport photographs for a new card.In the case of children aged 14 and over, an attestation of dependency and a school certificate should be returned with the card.Personnel DivisionTel. 79494/74683

  14. Provenance Query Protocol

    OpenAIRE

    Miles, S.; Moreau, L; Groth, P; Tan, V.; Munroe, S; Jiang, Sheng

    2006-01-01

    A related document defines schemas to be used for documentation about the execution of a process. It also defines the provenance of a data item as the process that led to that item. A provenance query is a query for the provenance of a data item and the results of such a query is documentation of the process that led to the item. In this document, we specify a protocol by which a querying actor and provenance store can communicate in performing a provenance query. This primarily takes the for...

  15. Transfusion protocol in trauma

    Directory of Open Access Journals (Sweden)

    Kaur Paramjit

    2011-01-01

    Full Text Available Blood and blood components are considered drugs because they are used in the treatment of diseases. As with any drug, adverse effects may occur, necessitating careful consideration of therapy. Like any other therapeutic decision, the need for transfusion should be considered on the basis of risks and benefits and alternative treatments available to avoid over- and under-transfusion. This review is focused on the blood transfusion protocol in trauma patients with hemorrhagic shock. Besides, issues related to emergency and massive transfusion have also been elaborated. We conducted a comprehensive MEDLINE search and reviewed the relevant literature, with particular reference to emergency medical care in trauma.

  16. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

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

  17. Security and SCADA protocols

    International Nuclear Information System (INIS)

    Supervisory control and data acquisition (SCADA) networks have replaced discrete wiring for many industrial processes, and the efficiency of the network alternative suggests a trend toward more SCADA networks in the future. This paper broadly considers SCADA to include distributed control systems (DCS) and digital control systems. These networks offer many advantages, but they also introduce potential vulnerabilities that can be exploited by adversaries. Inter-connectivity exposes SCADA networks to many of the same threats that face the public internet and many of the established defenses therefore show promise if adapted to the SCADA differences. This paper provides an overview of security issues in SCADA networks and ongoing efforts to improve the security of these networks. Initially, a few samples from the range of threats to SCADA network security are offered. Next, attention is focused on security assessment of SCADA communication protocols. Three challenges must be addressed to strengthen SCADA networks. Access control mechanisms need to be introduced or strengthened, improvements are needed inside of the network to enhance security and network monitoring, and SCADA security management improvements and policies are needed. This paper discusses each of these challenges. This paper uses the Profibus protocol as an example to illustrate some of the vulnerabilities that arise within SCADA networks. The example Profibus security assessment establishes a network model and an attacker model before proceeding to a list of example attacks. (authors)

  18. Staff compliance with protocols to improve the management of behavioral and psychological symptoms of dementia.

    Science.gov (United States)

    Mellor, David; McCabe, Marita; Bird, Michael; Davison, Tanya; MacPherson, Sarah; Hallford, David; Seedy, Melissa

    2015-02-01

    Using data from a larger study investigating the effectiveness of a structured clinical protocol to manage individuals in residential facilities who experience behavioral and psychological symptoms of dementia (BPSD), the current study investigated whether external clinical support in using the protocol with specific residents increased compliance in its use, over and above only providing a generic workshop about the protocol and management of BPSD. Results indicated that provision of the workshop, in addition to clinical support, was associated with significantly higher compliance. However, compliance was only found to be related to positive outcomes when staff received the generic workshop and not clinical support. When clinical support was provided, compliance was not related to outcomes or worse outcomes. These findings, when considered in the context of the results of the larger trial, suggest that the relationship among clinical support, compliance with BPSD protocols, and clinical outcomes for residents and staff is complex and needs further investigation. PMID:25019958

  19. Swab Protocol for Rapid Laboratory Diagnosis of Cutaneous Anthrax

    OpenAIRE

    Dauphin, Leslie A.; Marston, Chung K.; Bhullar, Vinod; Baker, Daniel; Rahman, Mahmudur; Hossain, M. Jahangir; Chakraborty, Apurba; Khan, Salah Uddin; Hoffmaster, Alex R.

    2012-01-01

    The clinical laboratory diagnosis of cutaneous anthrax is generally established by conventional microbiological methods, such as culture and directly straining smears of clinical specimens. However, these methods rely on recovery of viable Bacillus anthracis cells from swabs of cutaneous lesions and often yield negative results. This study developed a rapid protocol for detection of B. anthracis on clinical swabs. Three types of swabs, flocked-nylon, rayon, and polyester, were evaluated by 3 ...

  20. A prospective observational study to assess the diagnostic accuracy of clinical decision rules for children presenting to emergency departments after head injuries (protocol): the Australasian Paediatric Head Injury Rules Study (APHIRST)

    OpenAIRE

    Babl, Franz E; Lyttle, Mark D; Bressan, Silvia; Borland, Meredith; Phillips, Natalie; Kochar, Amit; Stuart R Dalziel; Dalton, Sarah; Cheek, John A; Furyk, Jeremy; Gilhotra, Yuri; Neutze, Jocelyn; Ward, Brenton; Donath, Susan; Jachno, Kim

    2014-01-01

    Background Head injuries in children are responsible for a large number of emergency department visits. Failure to identify a clinically significant intracranial injury in a timely fashion may result in long term neurodisability and death. Whilst cranial computed tomography (CT) provides rapid and definitive identification of intracranial injuries, it is resource intensive and associated with radiation induced cancer. Evidence based head injury clinical decision rules have been derived to aid...

  1. Formal Verification of Quantum Protocols

    CERN Document Server

    Nagarajan, R; Nagarajan, Rajagopal; Gay, Simon

    2002-01-01

    We propose to analyse quantum protocols by applying formal verification techniques developed in classical computing for the analysis of communicating concurrent systems. One area of successful application of these techniques is that of classical security protocols, exemplified by Lowe's discovery and fix of a flaw in the well-known Needham-Schroeder authentication protocol. Secure quantum cryptographic protocols are also notoriously difficult to design. Quantum cryptography is therefore an interesting target for formal verification, and provides our first example; we expect the approach to be transferable to more general quantum information processing scenarios. The example we use is the quantum key distribution protocol proposed by Bennett and Brassard, commonly referred to as BB84. We present a model of the protocol in the process calculus CCS and the results of some initial analyses using the Concurrency Workbench of the New Century (CWB-NC).

  2. Stream Control Transmission Protocol Steganography

    CERN Document Server

    Fraczek, Wojciech; Szczypiorski, Krzysztof

    2010-01-01

    Stream Control Transmission Protocol (SCTP) is a new transport layer protocol that is due to replace TCP (Transmission Control Protocol) and UDP (User Datagram Protocol) protocols in future IP networks. Currently, it is implemented in such operating systems like BSD, Linux, HP-UX or Sun Solaris. It is also supported in Cisco network devices operating system (Cisco IOS) and may be used in Windows. This paper describes potential steganographic methods that may be applied to SCTP and may pose a threat to network security. Proposed methods utilize new, characteristic SCTP features like multi-homing and multistreaming. Identified new threats and suggested countermeasures may be used as a supplement to RFC 5062, which describes security attacks in SCTP protocol and can induce further standard modifications.

  3. Survey protocol for invasive species

    OpenAIRE

    Menza, Charles

    2009-01-01

    This protocol was developed by the Biogeography Branch of NOAA’s Center for Coastal Monitoring and Assessment to support invasive species research by the Papahānaumokuākea Marine National Monument. The protocol’s objective is to detect Carijoa riisei and Hypnea musciformis in deepwater habitats using visual surveys by technical divers. Note: This protocol is designed to detect the presence or absence of invasive species. A distinct protocol is required to collect information on abundance ...

  4. Body surface area adapted iopromide 300 mg/ml versus 370 mg/ml contrast medium injection protocol: Influence on quantitative and clinical assessment in combined PET/CT

    International Nuclear Information System (INIS)

    Purpose: To investigate the quantitative and qualitative differences between combined positron emission tomography and computed X-ray tomography (PET/CT) enhanced with contrast medium with either an iodine concentration 300 mg/ml or 370 mg/ml. Materials and methods: 120 consecutive patients scheduled for F-18-Fluorodeoxyglucose (FDG) PET/CT were included. The first (second) 60 patients received contrast medium with 300 (370) mg iodine/ml. Intravenous injection protocols were adapted for an identical iodine delivery rate (1.3 mg/s) and body surface area (BSA) adapted iodine dose (22.26 g I/m2). Maximum and mean standardized uptake values (SUVmax; SUVmean) and contrast enhancement (HU) were determined in the ascending aorta, the abdominal aorta, the inferior vena cava, the portal vein, the liver and the right kidney in the venous contrast medium phase. PET data were evaluated visually for the presence of malignancy and image quality. Results: Both media caused significantly higher values for HU, SUVmean and SUVmax for the enhanced PET/CT than the non-enhanced one (all p < 0.01). There were no significant differences in the degree of increase of HU, SUVmean and SUVmax between the two contrast media at any anatomic site (all p > 0.05). Visual evaluation of lesions showed no differences between contrast and non-contrast PET/CT or between the two different contrast media (p = 0.77). Conclusion: When using a constant iodine delivery rate and total iodine dose in a BSA adapted injection protocol, there are no quantitative or qualitative differences in either CT or PET between contrast media with an iodine concentration of 300 mg/ml and 370 mg/ml, respectively

  5. Body surface area adapted iopromide 300 mg/ml versus 370 mg/ml contrast medium injection protocol: Influence on quantitative and clinical assessment in combined PET/CT

    Energy Technology Data Exchange (ETDEWEB)

    Verburg, Frederik A., E-mail: fverburg@ukaachen.de [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany); Maastricht University Medical Center, Department of Nuclear Medicine, P. Debyelaan 25, 6229 HX Maastricht (Netherlands); Apitzsch, Jonas [RWTH Aachen University Hospital, Department of Diagnostic and Interventional Radiology, Pauwelsstraße 30, 52074 Aachen (Germany); Lensing, Carina [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany); Kuhl, Christiane K. [RWTH Aachen University Hospital, Department of Diagnostic and Interventional Radiology, Pauwelsstraße 30, 52074 Aachen (Germany); Pietsch, Hubertus [Bayer Pharma AG, Müllerstrasse 178, 13353 Berlin (Germany); Mottaghy, Felix M. [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany); Maastricht University Medical Center, Department of Nuclear Medicine, P. Debyelaan 25, 6229 HX Maastricht (Netherlands); Behrendt, Florian F. [RWTH Aachen University Hospital, Department of Nuclear Medicine, Pauwelsstraße 30, 52074 Aachen (Germany)

    2013-12-01

    Purpose: To investigate the quantitative and qualitative differences between combined positron emission tomography and computed X-ray tomography (PET/CT) enhanced with contrast medium with either an iodine concentration 300 mg/ml or 370 mg/ml. Materials and methods: 120 consecutive patients scheduled for F-18-Fluorodeoxyglucose (FDG) PET/CT were included. The first (second) 60 patients received contrast medium with 300 (370) mg iodine/ml. Intravenous injection protocols were adapted for an identical iodine delivery rate (1.3 mg/s) and body surface area (BSA) adapted iodine dose (22.26 g I/m{sup 2}). Maximum and mean standardized uptake values (SUV{sub max}; SUV{sub mean}) and contrast enhancement (HU) were determined in the ascending aorta, the abdominal aorta, the inferior vena cava, the portal vein, the liver and the right kidney in the venous contrast medium phase. PET data were evaluated visually for the presence of malignancy and image quality. Results: Both media caused significantly higher values for HU, SUV{sub mean} and SUV{sub max} for the enhanced PET/CT than the non-enhanced one (all p < 0.01). There were no significant differences in the degree of increase of HU, SUV{sub mean} and SUV{sub max} between the two contrast media at any anatomic site (all p > 0.05). Visual evaluation of lesions showed no differences between contrast and non-contrast PET/CT or between the two different contrast media (p = 0.77). Conclusion: When using a constant iodine delivery rate and total iodine dose in a BSA adapted injection protocol, there are no quantitative or qualitative differences in either CT or PET between contrast media with an iodine concentration of 300 mg/ml and 370 mg/ml, respectively.

  6. Protocols for Scholarly Communication

    CERN Document Server

    Pepe, Alberto; Pepe, Alberto; Yeomans, Joanne

    2007-01-01

    CERN, the European Organization for Nuclear Research, has operated an institutional preprint repository for more than 10 years. The repository contains over 850,000 records of which more than 450,000 are full-text OA preprints, mostly in the field of particle physics, and it is integrated with the library's holdings of books, conference proceedings, journals and other grey literature. In order to encourage effective propagation and open access to scholarly material, CERN is implementing a range of innovative library services into its document repository: automatic keywording, reference extraction, collaborative management tools and bibliometric tools. Some of these services, such as user reviewing and automatic metadata extraction, could make up an interesting testbed for future publishing solutions and certainly provide an exciting environment for e-science possibilities. The future protocol for scientific communication should naturally guide authors towards OA publication and CERN wants to help reach a full...

  7. Mobile Multilayer IPsec protocol

    Directory of Open Access Journals (Sweden)

    T.Gayathri

    2009-08-01

    Full Text Available A mobile user moves around and switches between wireless cells, subnets and domains, it needs to maintain the session continuity. At the same time security of signaling and transport media should not be compromised. A multi-layer security framework involving user authentication, packet based encryption and access control mechanism can provide the desired level of security to the mobile users. Supporting streaming traffic in a mobile wireless Internet is faced with several challenges due to continuous handoff experienced by a mobile user. These challenges include dynamic binding, location management, quality of service and end-to-end security for signaling and transport. Mobile users will use heterogeneous radio access networking technologies. Mobile multilayer IPsec protocol (MML IPSec extends ML-IPSec to deal with mobility and make it suitable for wireless networks. MML-IPSec is integration of ML-IPSec and mobile IP.

  8. Compiling and securing cryptographic protocols

    CERN Document Server

    Chevalier, Yannick

    2009-01-01

    Protocol narrations are widely used in security as semi-formal notations to specify conversations between roles. We define a translation from a protocol narration to the sequences of operations to be performed by each role. Unlike previous works, we reduce this compilation process to well-known decision problems in formal protocol analysis. This allows one to define a natural notion of prudent translation and to reuse many known results from the literature in order to cover more crypto-primitives. In particular this work is the first one to show how to compile protocols parameterised by the properties of the available operations.

  9. Static Validation of Security Protocols

    DEFF Research Database (Denmark)

    Bodei, Chiara; Buchholtz, Mikael; Degano, P.; Nielson, Hanne Riis; Nielson, Flemming

    2005-01-01

    We methodically expand protocol narrations into terms of a process algebra in order to specify some of the checks that need to be made in a protocol. We then apply static analysis technology to develop an automatic validation procedure for protocols. Finally, we demonstrate that these techniques ...... suffice to identify several authentication flaws in symmetric and asymmetric key protocols such as Needham-Schroeder symmetric key, Otway-Rees, Yahalom, Andrew secure RPC, Needham-Schroeder asymmetric key, and Beller-Chang-Yacobi MSR...

  10. Examining Factors Influencing Colorectal Cancer Screening of Rural Nebraskans Using Data from Clinics Participating in an Accountable Care Organization: A Study Protocol [v1; ref status: indexed, http://f1000r.es/5me

    Directory of Open Access Journals (Sweden)

    Lufei Young

    2015-07-01

    Full Text Available Background: Although mortality rates of colorectal cancer (CRC can be significantly reduced through increased screening, rural communities are still experiencing lower rates of screening compared to urban counterparts. Understanding and eliminating barriers to cancer screening will decrease cancer burden and lead to substantial gains in quality and quantity of life for rural populations. However, existing studies have shown inconsistent findings and fail to address how contextual and provider-level factors impact CRC screening in addition to individual-level factors.  Purpose: The purpose of the study is to examine multi-level factors related to CRC screening, and providers’ perception of barriers and facilitators of CRC screening in rural patients cared for by accountable care organization (ACO clinics. Methods/Design: This is a convergent mixed method design. For the quantitative component, multiple data sources, such as electronic health records (EHRs, Area Resource File (ARF, and provider survey data, will be used to examine patient-, provider-, clinic-, and county-level factors. About 21,729 rural patients aged between 50 and 75 years who visited the participating ACO clinics in the past 12 months are included in the quantitative analysis. The qualitative methods include semi-structured in-depth interviews with healthcare professionals in selected rural clinics. Both quantitative and qualitative data will be merged for result interpretation. Quantitative data identifies “what” factors influence CRC screening, while qualitative data explores “how” these factors interact with CRC screening. The study setting is 10 ACO clinics located in nine rural Nebraska counties. Discussion: This will be the first study examining multi-level factors related to CRC screening in the new healthcare delivery system (i.e., ACO clinics in rural communities. The study findings will enhance our understanding of how the ACO model, particularly in rural

  11. Quantifying the magnitude and cost of collecting extraneous protocol data.

    Science.gov (United States)

    Getz, Kenneth A; Stergiopoulos, Stella; Marlborough, Michelle; Whitehill, Jane; Curran, Marla; Kaitin, Kenneth I

    2015-01-01

    Although most research professionals believe that protocol designs contain a growing number of unnecessary and redundant procedures generating unused data, incurring high cost, and jeopardizing study success, there are no published studies systematically examining this issue. Between November 2011 and May 2012, Tufts Center for the Study of Drug Development conducted a study among a working group of 15 pharmaceutical companies in which a total of 25,103 individual protocol procedures were evaluated and classified using clinical study reports and analysis plans. The results show that the typical later-stage protocol had an average of 7 objectives and 13 end points of which 53.8% are supplementary. One (24.7%) of every 4 procedures performed per phase-III protocol and 17.7% of all phase-II procedures per protocol were classified as "Noncore" in that they supported supplemental secondary, tertiary, and exploratory end points. For phase-III protocols, 23.6% of all procedures supported regulatory compliance requirements and 15.9% supported those for phase-II protocols. The study also found that on average, $1.7 million (18.5% of the total) is spent in direct costs to administer Noncore procedures per phase-III protocol and $0.3 million (13.1% of the total) in direct costs are spent on Noncore procedures for each phase-II protocol. Based on the results of this study, the total direct cost to perform Noncore procedures for all active annual phase-II and phase-III protocols is conservatively estimated at $3.7 billion annually, not including the indirect costs associated with collecting and managing Noncore procedure data and the ethical costs of exposing study volunteers to unnecessary risks associated with conducting extraneous procedures. PMID:23429165

  12. Extraction protocols for orthodontic treatment: A retrospective study

    Science.gov (United States)

    Thirunavukkarasu, Vaishnevi N.; Ramachandra, Srinivas Sulugodu; Dicksit, Daniel D.; Gundavarapu, Kalyan C.

    2016-01-01

    Background and Objectives: Various extraction protocols have been followed for successful orthodontic treatment. The purpose of this study was to evaluate the extraction protocols in patients who had previously undergone orthodontic treatment and also who had reported for continuing orthodontic treatment from other clinics. Materials and Methods: One hundred thirty eight patients who registered for orthodontic treatment at the Faculty of Dentistry were divided into 10 extraction protocols based on the Orthodontic treatment protocol given by Janson et al. and were evaluated for statistical significance. Results: The descriptive statistics of the study revealed a total of 40 (29%) patients in protocol 1, 43 (31.2%) in protocol 2, 18 (13%) in protocol 3, 16 (11.6%) in protocol 5, and 12 (8.7%) in Type 3 category of protocol 9. The Type 3 category in protocol 9 was statistically significant compared to other studies. Midline shift and collapse of the arch form were noticed in these individuals. Conclusion: Extraction of permanent teeth such as canine and lateral incisors without rational reasons could have devastating consequences on the entire occlusion. The percentage of cases wherein extraction of permanent teeth in the crowded region was adopted as a treatment option instead of orthodontic treatment is still prevalent in dental practice. The shortage of orthodontists in Malaysia, the long waiting period, and lack of subjective need for orthodontic treatment at an earlier age group were the reasons for the patient's to choose extraction of the mal-aligned teeth such as the maxillary canine or maxillary lateral incisors. PMID:27041899

  13. The REFER (REFer for EchocaRdiogram protocol: a prospective validation of a clinical decision rule, NT-proBNP, or their combination, in the diagnosis of heart failure in primary care. Rationale and design

    Directory of Open Access Journals (Sweden)

    Tait Lynda

    2012-10-01

    Full Text Available Abstract Background Heart failure is a major cause of mortality and morbidity. As mortality rates are high, it is important that patients seen by general practitioners with symptoms suggestive of heart failure are identified quickly and treated appropriately. Identifying patients with heart failure or deciding which patients need further tests is a challenge. All patients with suspected heart failure should be diagnosed using objective tests such as echocardiography, but it is expensive, often delayed, and limited by the significant skill shortage of trained echocardiographers. Alternative approaches for diagnosing heart failure are currently limited. Clinical decision tools that combine clinical signs, symptoms or patient characteristics are designed to be used to support clinical decision-making and validated according to strict methodological procedures. The REFER Study aims to determine the accuracy and cost-effectiveness of our previously derived novel, simple clinical decision rule, a natriuretic peptide assay, or their combination, in the triage for referral for echocardiography of symptomatic adult patients who present in general practice with symptoms suggestive of heart failure. Methods/design This is a prospective, Phase II observational, diagnostic validation study of a clinical decision rule, natriuretic peptides or their combination, for diagnosing heart failure in primary care. Consecutive adult primary care patients 55 years of age or over presenting to their general practitioner with a chief complaint of recent new onset shortness of breath, lethargy or peripheral ankle oedema of over 48 hours duration, with no obvious recurrent, acute or self-limiting cause will be enrolled. Our reference standard is based upon a three step expert specialist consensus using echocardiography and clinical variables and tests. Discussion Our clinical decision rule offers a potential solution to the diagnostic challenge of providing a timely and

  14. Efeito da implantação de um protocolo assistencial de asma aguda no serviço de emergência de um hospital universitário Effect of a clinical protocol on the management of acute asthma in the emergency room of a university hospital

    Directory of Open Access Journals (Sweden)

    Pérsio Mariano da Rocha

    2004-04-01

    Full Text Available INTRODUÇÃO: Existe grande variabilidade de prática clínica no tratamento da asma aguda na sala de emergência, o que interfere na qualidade de atendimento. OBJETIVO: Avaliar o efeito da implantação de um protocolo assistencial de asma aguda no Serviço de Emergência do Hospital de Clínicas de Porto Alegre. MÉTODO: Estudo transversal, antes e após a implantação do protocolo assistencial de asma aguda no setor de adultos (idade > 12 anos do referido serviço, avaliando o efeito das recomendações sobre a avaliação objetiva da gravidade, solicitações de exames, uso de terapêutica recomendada, uso de terapêutica não-recomendada e desfechos da crise. RESULTADOS: Na fase pré-implantação, foram estudados 108 pacientes e, na fase pós-implantação, 96 pacientes. Houve aumento na utilização da oximetria de pulso (de 8% para 77%, p BACKGROUND: There is a wide variability in clinical practice for treating acute asthma (AA in the emergency room (ER interfering in the quality of management. OBJECTIVE: To evaluate the impact of a clinical protocol for care of acute asthma in the ER of the Hospital de Clínicas de Porto Alegre. METHOD: In this hospital a cross-sectional study was conducted before and after implementation of the protocol, of consecutive patients presenting with acute asthma in the adult ER (age > 12 years. The intention was to measure the effect of recommendations on the objective assessment of severity, utilization of diagnostic tools, proposed therapy, not recommended therapy and on the outcomes. RESULTS: The pre-protocol group comprised 108 patients and the protocol group comprised 96 patients. There was a significant increase in the use of pulse oximetry (8% to 77%, p<0.001 and PEFR (5% to 21%, p<0.001. There was an increase in the utilization of radiology (33% to 66%, p<0.001 and in that of blood tests (11% to 25%, p=0.016. There was also an increase in the number of patients receiving the three recommended

  15. Course on dosimetric protocols

    International Nuclear Information System (INIS)

    Several papers about dosimeters calibration are presented. The emphasis is given to the quality control for clinical dosemeters. The calibration necessary for Secondary Standard Pattern Laboratory are shown and the installations and shields for an linear accelerator room are cited. (E.G.)

  16. Shoulder muscle endurance: the development of a standardized and reliable protocol

    Directory of Open Access Journals (Sweden)

    Roy Jean-Sébastien

    2011-01-01

    Full Text Available Abstract Background Shoulder muscle fatigue has been proposed as a possible link to explain the association between repetitive arm use and the development of rotator cuff disorders. To our knowledge, no standardized clinical endurance protocol has been developed to evaluate the effects of muscle fatigue on shoulder function. Such a test could improve clinical examination of individuals with shoulder disorders. Therefore, the purpose of this study was to establish a reliable protocol for objective assessment of shoulder muscle endurance. Methods An endurance protocol was developed on a stationary dynamometer (Biodex System 3. The endurance protocol was performed in isotonic mode with the resistance set at 50% of each subject's peak torque as measured for shoulder external (ER and internal rotation (IR. Each subject performed 60 continuous repetitions of IR/ER rotation. The endurance protocol was performed by 36 healthy individuals on two separate occasions at least two days apart. Maximal isometric shoulder strength tests were performed before and after the fatigue protocol to evaluate the effects of the endurance protocol and its reliability. Paired t-tests were used to evaluate the reduction in shoulder strength due to the protocol, while intraclass correlation coefficients (ICC and minimal detectable change (MDC were used to evaluate its reliability. Results Maximal isometric strength was significantly decreased after the endurance protocol (P 0.84. Conclusions Changes in muscular performance observed during and after the muscular endurance protocol suggests that the protocol did result in muscular fatigue. Furthermore, this study established that the resultant effects of fatigue of the proposed isotonic protocol were reproducible over time. The protocol was performed without difficulty by all volunteers and took less than 10 minutes to perform, suggesting that it might be feasible for clinical practice. This protocol could be used to induce

  17. Comparison of a new whole-body continuous-table-movement protocol versus a standard whole-body MR protocol for the assessment of multiple myeloma

    Energy Technology Data Exchange (ETDEWEB)

    Weckbach, S. [University Hospital Munich-Grosshadern Campus, Department of Clinical Radiology, Munich (Germany); University Hospital Mannheim, Medical Faculty Mannheim, University of Heidelberg, Department of Clinical Radiology and Nuclear Medicine, Mannheim (Germany); Michaely, H.J.; Schoenberg, S.O.; Dinter, D.J. [University Hospital Mannheim, Medical Faculty Mannheim, University of Heidelberg, Department of Clinical Radiology and Nuclear Medicine, Mannheim (Germany); Stemmer, A. [Siemens AG, Healthcare Sector, Imaging and IT Division, Magnetic Resonance, Erlangen (Germany)

    2010-12-15

    To evaluate a whole body (WB) continuous-table-movement (CTM) MR protocol for the assessment of multiple myeloma (MM) in comparison to a step-by-step WB protocol. Eighteen patients with MM were examined at 1.5T using a WB CTM protocol (axial T2-w fs BLADE, T1-w GRE sequence) and a step-by-step WB protocol including coronal/sagittal T1-w SE and STIR sequences as reference. Protocol time was assessed. Image quality, artefacts, liver/spleen assessability, and the ability to depict bone marrow lesions less than or greater than 1 cm as well as diffuse infiltration and soft tissue lesions were rated. Potential changes in the Durie and Salmon Plus stage and the detectability of complications were assessed. Mean protocol time was 6:38 min (CTM) compared to 24:32 min (standard). Image quality was comparable. Artefacts were more prominent using the CTM protocol (P = 0.0039). Organ assessability was better using the CTM protocol (P < 0.001). Depiction of bone marrow and soft tissue lesions was identical without a staging shift. Vertebral fractures were not detected using the CTM protocol. The new protocol allows a higher patient throughput and facilitates the depiction of extramedullary lesions. However, as long as vertebral fractures are not detectable, the protocol cannot be safely used for clinical routine without the acquisition of an additional sagittal sequence. (orig.)

  18. Protocol-directed care in the ICU: making a future generation of intensivists less knowledgeable?

    OpenAIRE

    Diringer, Erik; Yende, Sachin

    2012-01-01

    Expanded abstract Citation Prasad M, Holmboe ES, Lipner RS, Hess BJ, Christie JD, Bellamy SL, Rubenfeld GD, Kahn JM. Clinical Protocols and Trainee Knowledge About Mechanical Ventilation. JAMA. 2011; 306(9):935-941. PubMed PMID: 21900133 This is available on http://www.pubmed.gov Background Clinical protocols are associated with improved patient outcomes; however, they may negatively affect medical education by removing trainees from clinical decision making. Methods Objective: To study the r...

  19. Protocols for Scholarly Communication

    Science.gov (United States)

    Pepe, A.; Yeomans, J.

    2007-10-01

    CERN, the European Organization for Nuclear Research, has operated an institutional preprint repository for more than 10 years. The repository contains over 850,000 records of which more than 450,000 are full-text OA preprints, mostly in the field of particle physics, and it is integrated with the library's holdings of books, conference proceedings, journals and other grey literature. In order to encourage effective propagation and open access to scholarly material, CERN is implementing a range of innovative library services into its document repository: automatic keywording, reference extraction, collaborative management tools and bibliometric tools. Some of these services, such as user reviewing and automatic metadata extraction, could make up an interesting testbed for future publishing solutions and certainly provide an exciting environment for e-science possibilities. The future protocol for scientific communication should guide authors naturally towards OA publication, and CERN wants to help reach a full open access publishing environment for the particle physics community and related sciences in the next few years.

  20. Internet Protocol Television (IPTV

    Directory of Open Access Journals (Sweden)

    Lokesh Mittal

    2012-09-01

    Full Text Available IPTV is one of the mostly used technology of Internet and IP application. IPTV is a service for the delivery of broadcast TV, movies on demand and other interactive multimedia services over a secure, end-to-end operator managed broadband IP data network with desired QoS to the public with a broadband Internet connection. IPTV system may also include Internet services such as Web access and VoIP where it may be called Triple Play and is typically supplied by a broadband operator using the same infrastructure. IPTV is not the Internet Video that simply allows users to watch videos, like movie previews and web-cams, over the Internet in a best effort fashion. IPTV technology offers revenue-generating opportunities for the telecom and cable service providers. For traditional telephone service providers, Triple Play is delivered using a combination of optical fiber and Digital Subscriber Line (DSL technologies to its residential base. IPTV is a system where a digital television service is delivered by using Internet Protocol over a network infrastructure, which may include delivery by a broadband connection. A general definition of IPTV is television content that, instead of being delivered through traditional broadcast and cable formats, is received by the viewer through the technologies used for computer networks. In this paper I am trying to discuss this topic as my knowledge, including what is IPTV, how it works, its advantages and its applications

  1. AN IMPROVED AUTHENTICATED KEY AGREEMENT PROTOCOL

    Institute of Scientific and Technical Information of China (English)

    2005-01-01

    In 1999, Seo and Sweeney proposed a simple authenticated key agreement protocol that was designed to act as a Diffie-Hellman key agreement protocol with user authentication.Various attacks on this protocol are described and enhanced in the literature. Recently, Ku and Wang proposed an improved authenticated key agreement protocol, where they asserted the protocol could withstand the existing attacks. This paper shows that Ku and Wang's protocol is still vulnerable to the modification attack and presents an improved authenticated key agreement protocol to enhance the security of Ku and Wang's protocol. The protocol has more efficient performance by replacing exponentiation operations with message authentication code operations.

  2. Exploring the feasibility and synergistic value of the One Health approach in clinical research: protocol for a prospective observational study of diagnostic pathways in human and canine patients with suspected urinary tract infection

    DEFF Research Database (Denmark)

    Cordoba Currea, Gloria Cristina; Sørensen, Tina Møller; Holm, Anne; Bjørnvad, Charlotte Reinhard; Bjerrum, Lars; Jessen, Lisbeth Rem

    2015-01-01

    Introduction: The One Health approach is emerging in response to the development of bacterial resistance. To the best of our knowledge, the possibility to use this approach in a clinical context has not yet been explored. Thus, in this paper we report the procedures to implement a prospective obs...... implement common interventions aimed at influencing the diagnostic process in human and canine patients in order to decrease inappropriate use of antibiotics....... observational study of diagnostic pathways in human and canine patients with suspected urinary tract infection as a means to assess the feasibility and synergistic value of setting up One Health clinical research projects and interventions. Methods and analysis: A prospective observational study will compare......-10 days following inclusion, d) urine culture (type of microorganism and susceptibility test). The feasibility and synergistic value of conducting future research, and/or designing common interventions, will be assessed by evaluating the comparability of human primary care and veterinary primary care with...

  3. Rationale, design, and implementation protocol of the Dutch clinical practice guideline Pain in patients with cancer: a cluster randomised controlled trial with short message service (SMS) and interactive voice response (IVR)

    OpenAIRE

    te Boveldt Nienke; Engels Yvonne; Besse Kees; Vissers Kris; Vernooij-Dassen Myrra

    2011-01-01

    Abstract Background One-half of patients with cancer have pain. In nearly one out of two cancer patients with pain, this was undertreated. Inadequate pain control still remains an important problem in this group of patients. Therefore, in 2008 a national, evidence-based multidisciplinary clinical practice guideline 'pain in patients with cancer' has been developed. Yet, publishing a guideline is not enough. Implementation is needed to improve pain management. An innovative implementation stra...

  4. ComOn Coaching: Study protocol of a randomized controlled trial to assess the effect of a varied number of coaching sessions on transfer into clinical practice following communication skills training

    OpenAIRE

    Niglio de Figueiredo, Marcelo; Rodolph, Bärbel; Bylund, Carma L.; Goelz, Tanja; Heußner, Pia; Sattel, Heribert; Fritzsche, Kurt; Wuensch, Alexander

    2015-01-01

    Background Communication skills training has proven to be an effective means to enhance communication of health care professionals in oncology. These effects are well studied in standardized settings. The question of transferring these skills into clinical consultations remains open. We build up on a previous developed training concept consisting of a workshop and coaching. This training achieved a medium effect size in two studies with standardized patients. In the current study, we expanded...

  5. Clinical evaluation of short 6-mm implants alone, short 8-mm implants combined with osteotome sinus floor elevation and standard 10-mm implants combined with osteotome sinus floor elevation in posterior maxillae: study protocol for a randomized controlled trial

    OpenAIRE

    Shi, Jun-Yu; Gu, Ying-Xin; Qiao, Shi-Chong; Zhuang, Long-Fei; Zhang, Xiao-Meng; Lai, Hong-Chang

    2015-01-01

    Background Nowadays, short dental implants are being increasingly applied in extremely resorbed posterior regions. The recent studies have indicated that short implants present a similar success rate to conventional implants. It is assumed that short implants can avoid additional surgical morbidity and are less technically demanding. However, high-quality evidence (≥Ib: evidence from at least one randomized controlled trial) on comparing the clinical outcome of short implants and longer impla...

  6. The iTreAD project: a study protocol for a randomised controlled clinical trial of online treatment and social networking for binge drinking and depression in young people

    OpenAIRE

    Kay-Lambkin, F. J.; Baker, A L; Geddes, J.; Hunt, S. A.; Woodcock, K. L.; Teesson, M.; Oldmeadow, C; Lewin, T.J.; Bewick, B. M.; Brady, K; Spring, B; Deady, M.; Barrett, E.; Thornton, L.

    2015-01-01

    Background Depression and binge drinking behaviours are common clinical problems, which cause substantial functional, economic and health impacts. These conditions peak in young adulthood, and commonly co-occur. Comorbid depression and binge drinking are undertreated in young people, who are reluctant to seek help via traditional pathways to care. The iTreAD project (internet Treatment for Alcohol and Depression) aims to provide and evaluate internet-delivered monitoring and treatment program...

  7. The fitness for the Ageing Brain Study II (FABS II): protocol for a randomized controlled clinical trial evaluating the effect of physical activity on cognitive function in patients with Alzheimer's disease

    OpenAIRE

    Ames David; Flicker Leon; Almeida Osvaldo P; Cox Kay L; Cyarto Elizabeth V; Byrne Gerard; Hill Keith D; Beer Christopher D; LoGiudice Dina; Appadurai Kana; Irish Muireann; Renehan Emma; Lautenschlager Nicola T

    2010-01-01

    Abstract Background Observational studies have documented a potential protective effect of physical exercise in older adults who are at risk for developing Alzheimer's disease. The Fitness for the Ageing Brain II (FABS II) study is a multicentre randomized controlled clinical trial (RCT) aiming to determine whether physical activity reduces the rate of cognitive decline among individuals with Alzheimer's disease. This paper describes the background, objectives of the study, and an overview of...

  8. Standing up in multiple sclerosis (SUMS): protocol for a multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of a home-based self-management standing frame programme in people with progressive multiple sclerosis

    OpenAIRE

    Freeman, J. A.; Hendrie, W.; Creanor, S.; Jarrett, L.; Barton, A; Green, C.; Marsden, J.; Rogers, E.; Zajicek, J

    2016-01-01

    Background Multiple sclerosis (MS) is an incurable, unpredictable but typically progressive neurological condition. It is the most common cause of neurological disability in young adults. Within 15 years of diagnosis, approximately 50 % of affected people are unable to walk unaided, and over time an estimated 25 % depend on a wheelchair. Typically, people with such limited mobility are excluded from clinical trials. Severely impaired people with MS spend much of their day sitting, often with ...

  9. Data Link Layer Protocol Simulator User Guide

    OpenAIRE

    Nataf, Emmanuel

    2008-01-01

    The data link layer protocol simulator allows to write protocol and to see them in execution. This guide describes a step by step approach from simple information communication without any control to windows protocols. A protocol oriented java API is defined to write protocol algorithms.

  10. Caspase Protocols in Mice

    OpenAIRE

    Kaushal, Varsha; Herzog, Christian; Haun, Randy S.; Kaushal, Gur P.

    2014-01-01

    Members of the caspase family of proteases are evolutionarily conserved cysteine proteases that play a crucial role as the central executioners of the apoptotic pathway. Since the discovery of caspases, many methods have been developed to detect their activation and are widely used in basic and clinical studies. In a mouse tissue, caspase activation can be monitored by cleavage of caspase-specific synthetic substrates and by detecting cleaved caspase by western blot analysis of the tissue ext...

  11. Economic analysis of a phase III clinical trial evaluating the addition of total androgen suppression to radiation versus radiation alone for locally advanced prostate cancer (Radiation Therapy Oncology Group protocol 86-10)

    International Nuclear Information System (INIS)

    Purpose: To evaluate the cost-effectiveness of adding hormone therapy to radiation for patients with locally advanced prostate cancer, using a Monte Carlo simulation of a Markov Model. Methods and Materials: Radiation Therapy Oncology Group (RTOG) protocol 86-10 randomized patients to receive radiation therapy (RT) alone or RT plus total androgen suppression (RTHormones) 2 months before and during RT for the treatment of locally advanced prostate cancer. A Markov model was designed with Data Pro (TreeAge Software, Williamstown, MA). The analysis took a payer's perspective. Transition probabilities from one state of health (i.e., with no disease progression or with hormone-responsive metastatic disease) to another were calculated from published rates pertaining to RTOG 86-10. Patients remained in one state of health for 1 year. Utility values for each health state and treatment were obtained from the literature. Distributions were sampled at random from the treatment utilities according to a second-order Monte Carlo simulation technique. Results: The mean expected cost for the RT-only treatments was $29,240 (range, $29,138-$29,403). The mean effectiveness for the RT-only treatment was 5.48 quality-adjusted life years (QALYs) (range, 5.47-5.50). The mean expected cost for RTHormones was $31,286 (range, $31,058-$31,555). The mean effectiveness was 6.43 QALYs (range, 6.42-6.44). Incremental cost-effectiveness analysis showed RTHormones to be within the range of cost-effectiveness at $2,153/QALY. Cost-effectiveness acceptability curve analysis resulted in a >80% probability that RTHormones is cost-effective. Conclusions: Our analysis shows that adding hormonal treatment to RT improves health outcomes at a cost that is within the acceptable cost-effectiveness range

  12. Describing the characteristics, treatment pathways, outcomes, and costs of people with persistent noncancer pain managed by community pain clinics and generating an indicative estimate of cost-effectiveness: feasibility study protocol

    Directory of Open Access Journals (Sweden)

    AlAujan S

    2016-05-01

    Full Text Available Shiekha AlAujan,1 Saja AlMazrou,1 Roger D Knaggs,1,2 Rachel A Elliott11Division for Social Research in Medicines and Health, The School of Pharmacy, University of Nottingham, Nottingham, UK; 2Pharmacy Department and Pain Management Service, Nottingham University Hospitals NHS Trust, Nottingham, UKBackground: Low back pain (LBP and fibromyalgia (FM, also known as chronic widespread pain (CWP, are highly prevalent chronic painful conditions that have substantial impact on patients, health care systems, and society. Diagnosis is complex and management strategies are associated with various levels of evidence for effectiveness and cost-effectiveness. Multidisciplinary pain services have been shown to be effective in some settings and therefore are recommended by clinical practice guidelines as a rational treatment option to manage these patients. Knowing that these services are resource intensive, evidence is needed to demonstrate their cost-effectiveness. This study aims to describe the management of patients with LBP and FM in two community pain clinics to derive an indicative estimate of cost-effectiveness compared with standard practice.Methods: This is a prospective observational multicenter study, using patient-level data. The data from this study will be combined with modelling of the long-term economic impact of community pain clinics in treating people with LBP and FM. Newly referred patients with LBP and FM who provide written consent will be included. We will collect data on functional disability, pain intensity, quality of life, and health resource utilization. Follow-up data at the 3- and 6-month points will be collected by patient-completed questionnaires and health care contact diaries. Health care resource use from diaries will be compared with patient electronic records to assess the agreement between these recording methods. Patient cohort characteristics, treatment pathways, resource use, and outcomes derived from this study will

  13. Performance Evaluation of Security Protocols

    CERN Document Server

    Genge, Bela

    2009-01-01

    We propose a comparative performance evaluation of security protocols. The novelty of our approach lies in the use of a polynomial mathematical model that captures the performance of classes of cryptographic algorithms instead of capturing the performance of each algorithm separately, approach that is used in other papers. A major advantage of using such a model is that it does not require implementation-specific information, because the decision is based on comparing the estimated performances of protocols instead of actually evaluating them. The approach is validated by comparatively evaluating the performances of 1000 automatically generated security protocols against the performances of their actual implementations.

  14. The evaluation of MRI protocols for the quantification of adiposity in the obese

    International Nuclear Information System (INIS)

    Obesity is a recognized risk factor for the development of diseases such as atherosclerosis, diabetes mellitus and hypertension. The individual risk of the obesity can not be evaluated merely by the body weight or body mass index. The fat distribution is a key to evaluate it. So far, the MRI protocols in the literature tested for the evaluation of the fat distribution were spin-echo and inversion-recovery images. We tested both protocols and couldn't get good images basically due to motion artifacts. Therefore, the field-echo (FE) protocol, a rapid scan protocol, was evaluated. The transverse fat distributions at umbilical level of 8 male obese volunteers were examined with MRI FE protocol and X-ray computed tomography (CT). The excellent images were obtained with FE protocol and correlation with CT images was also satisfactory. The FE protocols for the evaluation of the fat distribution is of use and reasonable tool for the clinical usage. (author)

  15. Overcoming Recruitment Challenges in Palliative Care Clinical Trials

    OpenAIRE

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

    2013-01-01

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

  16. Effectiveness of a biopsychosocial e-learning intervention on the clinical judgements of medical students and GP trainees regarding future risk of disability in patients with chronic lower back pain: study protocol for a randomised controlled trial

    Science.gov (United States)

    Dwyer, Christopher P; MacNeela, Pádraig; Reynolds, Bronagh; Hamm, Robert M; Main, Christopher J; O'Connor, Laura L; Conneely, Sinéad; Taheny, Darragh; Slattery, Brian W; O'Neill, Ciaran; NicGabhainn, Saoirse; Murphy, Andrew W; Kropmans, Thomas; McGuire, Brian E

    2016-01-01

    Introduction Chronic lower back pain (CLBP) is a major healthcare problem with wide ranging effects. It is a priority for appropriate management of CLBP to get individuals back to work as early as possible. Interventions that identify biopsychosocial barriers to recovery have been observed to lead to successfully reduced pain-related work absences and increased return to work for individuals with CLBP. Modern conceptualisations of pain adopt a biopsychosocial approach, such as the flags approach. Biopsychosocial perspectives have been applied to judgements about future adjustment, recovery from pain and risk of long-term disability; and provide a helpful model for understanding the importance of contextual interactions between psychosocial and biological variables in the experience of pain. Medical students and general practitioner (GP) trainees are important groups to target with education about biopsychosocial conceptualisations of pain and related clinical implications. Aim The current study will compare the effects of an e-learning intervention that focuses on a biopsychosocial model of pain, on the clinical judgements of medical students and trainees. Methods and analysis Medical student and GP trainee participants will be randomised to 1 of 2 study conditions: (1) a 20 min e-learning intervention focused on the fundamentals of the flags approach to clinical judgement-making regarding risk of future pain-related disability; compared with a (2) wait-list control group on judgement accuracy and weighting (ie, primary outcomes); flags approach knowledge, attitudes and beliefs towards pain, judgement speed and empathy (ie, secondary outcomes). Participants will be assessed at preintervention and postintervention. Ethics and dissemination The study will be performed in agreement with the Declaration of Helsinki and is approved by the National University of Ireland Galway Research Ethics Committee. The results of the trial will be published according to the

  17. INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?: study protocol for a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of invasive urodynamic testing

    Directory of Open Access Journals (Sweden)

    Armstrong Natalie

    2011-07-01

    Full Text Available Abstract Background Urinary incontinence is an important health problem to the individual sufferer and to health services. Stress and stress predominant mixed urinary incontinence are increasingly managed by surgery due to advances in surgical techniques. Despite the lack of evidence for its clinical utility, most clinicians undertake invasive urodynamic testing (IUT to confirm a functional diagnosis of urodynamic stress incontinence before offering surgery for this condition. IUT is expensive, embarrassing and uncomfortable for women and carries a small risk. Recent systematic reviews have confirmed the lack of high quality evidence of effectiveness. The aim of this pilot study is to test the feasibility of a future definitive randomised control trial that would address whether IUT alters treatment decisions and treatment outcome in these women and would test its clinical and cost effectiveness. Methods/design This is a mixed methods pragmatic multicentre feasibility pilot study with four components:- (a A multicentre, external pilot randomised trial comparing basic clinical assessment with non-invasive tests and IUT. The outcome measures are rates of recruitment, randomisation and data completion. Data will be used to estimate sample size necessary for the definitive trial. (b Qualitative interviews of a purposively sampled sub-set of women eligible for the pilot trial will explore willingness to participate, be randomised and their overall trial experience. (c A national survey of clinicians to determine their views of IUT in this context, the main outcome being their willingness to randomise patients into the definitive trial. (d Qualitative interviews of a purposively sampled group of these clinicians will explore whether and how they use IUT to inform their decisions. Discussion The pilot trial will provide evidence of feasibility and acceptability and therefore inform the decision whether to proceed to the definitive trial. Results will

  18. Fatigue In Teenagers on the interNET - The FITNET Trial. A randomized clinical trial of web-based cognitive behavioural therapy for adolescents with chronic fatigue syndrome: study protocol. [ISRCTN59878666

    Directory of Open Access Journals (Sweden)

    Kimpen Jan LL

    2011-02-01

    Full Text Available Abstract Background Chronic Fatigue Syndrome (CFS is increasingly recognized as a cause of disability and inactivity in adolescents in the Netherlands. CFS is characterized by unexplained fatigue lasting more than 6 months. Cognitive Behavioural Therapy (CBT has proven to be effective. However, CBT availability for adolescents with CFS is limited and requires special therapeutic skills not always readily available. An alternative to the face-to-face CBT is FITNET, a web-based therapeutic program designed specifically for adolescents diagnosed with CFS, and their parents. This new CBT approach appeals to the modern youth, who grow up with internet as their main source of information. A web-based program offers the opportunity to lower thresholds for the acceptance and realization of healthcare. This treatment can be activated at any chosen time. The communication between patient and therapist can elapse asynchronously. If effective, this web-based program would greatly increase the therapeutic accessibility. Methods/Design A randomized clinical trial is currently conducted. One-hundred-forty adolescents aged 12-18 years diagnosed with CFS will be recruited and randomized to one of two groups: FITNET or usual care. After 6 months, the usual care group will have access to the FITNET program. Outcomes will be assessed at baseline, post intervention, and at 6 months follow-up. Primary outcome measures are school presence, fatigue severity, and physical functioning. Discussion The FITNET study is the first randomized clinical trial which evaluates the effect of web-based CBT versus usual care in adolescents with CFS. The intervention is based on a theoretical existing model of CBT for patients with CFS. The results of this study will provide information about the possibility and efficacy of web-based CBT for adolescents with CFS and will reveal predictors of efficacy. Trial registration ISRCTN: ISRCTN59878666 and ClinicalTrials.gov: NCT00893438

  19. Safety and Immunogenicity of Early Measles Vaccination in Children Born to HIV-Infected Mothers in the United States: Results of Pediatric AIDS Clinical Trials Group (PACTG) Protocol 225

    OpenAIRE

    Chandwani, Sulachni; Beeler, Judy; Li, Hong; Audet, Susette; Smith, Betsy; Moye, John; Nalin, David; Krasinski, Keith

    2011-01-01

    Background. PACTG (Pediatric AIDS Clinical Trials Group) 225, a multicenter, randomized, open-label trial in the United States evaluated reactogenicity and immunogenicity of 2 vaccination regimens: monovalent measles vaccine (Attenuvax) at 6 months of age and measles, mumps, and rubella, live attenuated (MMRII) vaccine at 12 months of age (2D), or only MMRII at 12 months of age (1D) in human immunodeficiency virus–infected (HIV-infected) (POS) and uninfected (NEG) children in the pre–highly a...

  20. The Effectiveness of Parent Training as a Treatment for Preschool Attention-Deficit/Hyperactivity Disorder: Study Protocol for a Randomized Controlled, Multicenter Trial of the New Forest Parenting Program in Everyday Clinical Practice

    Science.gov (United States)

    Daley, David; Frydenberg, Morten; Rask, Charlotte U; Sonuga-Barke, Edmund; Thomsen, Per H

    2016-01-01

    Background Parent training is recommended as the first-line treatment for attention-deficit/hyperactivity disorder (ADHD) in preschool children. The New Forest Parenting Programme (NFPP) is an evidence-based parenting program developed specifically to target preschool ADHD. Objective The objective of this trial is to investigate whether the NFPP can be effectively delivered for children referred through official community pathways in everyday clinical practice. Methods A multicenter randomized controlled parallel arm trial design is employed. There are two treatment arms, NFPP and treatment as usual. NFPP consists of eight individually delivered parenting sessions, where the child attends during three of the sessions. Outcomes are examined at three time points (T1, T2, T3): T1 (baseline), T2 (week 12, post intervention), and T3 (6 month follow/up). 140 children between the ages of 3-7, with a clinical diagnosis of ADHD, informed by the Development and Well Being Assessment, and recruited from three child and adolescent psychiatry departments in Denmark will take part. Randomization is on a 1:1 basis, stratified for age and gender. Results The primary endpoint is change in ADHD symptoms as measured by the Preschool ADHD-Rating Scale (ADHD-RS) by T2. Secondary outcome measures include: effects on this measure at T3 and T2 and T3 measures of teacher reported Preschool ADHD-RS scores, parent and teacher rated scores on the Strength & Difficulties Questionnaire, direct observation of ADHD behaviors during Child’s Solo Play, observation of parent-child interaction, parent sense of competence, and family stress. Results will be reported using the standards set out in the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of nonpharmacological treatments. Conclusions The trial will provide evidence as to whether NFPP is a more effective treatment for preschool ADHD than the treatment usually offered in everyday clinical practice. Trial

  1. Clinical efficacy of antazoline in rapid cardioversion of paroxysmal atrial fibrillation -- a protocol of a single center, randomized, double-blind, placebo-controlled study (the AnPAF Study

    Directory of Open Access Journals (Sweden)

    Farkowski Michal M

    2012-09-01

    Full Text Available Abstract Background Rapid conversion of atrial fibrillation (AF to sinus rhythm may be achieved by the administration of class IA, IC and III antiarrhythmic drugs or vernakalant hydrochloride. However, that treatment may be related to potential pro-arrhythmia, lack of efficacy or the exceptionally high cost of a compound used. Antazoline is a first generation antihistaminic agent with chinidin-like properties. When administered intravenously, antazoline exerts a strong antiarrhythmic effect on supraventricular arrhythmia, especially on AF, facilitating rapid conversion to sinus rhythm. Despite a relative lack of published data antazoline has been marketed in Poland and widely used in cardiology wards and emergency rooms for many years due to its efficacy, safety and rapid onset of action within minutes of administration. Methods/design A randomized, double blind, placebo-controlled, superiority clinical trial was designed to assess clinical efficacy of antazoline in rapid conversion of AF to sinus rhythm. Eligible patients will present AF lasting less than 43 hours, will be in stable cardio-pulmonary condition and will have no prior history of advanced heart failure or significant valvular disease. Long-term antiarrhythmic therapy is not considered an exclusion criterion. Subjects who fulfill selection criteria will be randomly assigned to receive intravenously either antazoline or placebo in divided doses and observed for 1.5 hours after conversion to sinus rhythm or after the last i.v. bolus. Primary end point will be the conversion of AF to sinus rhythm confirmed in an electrocardiogram (ECG during the observation period. Secondary end points will be comprised of time to conversion and return of AF during the observation period. Special consideration will be given to the observation of any adverse events. A sample size of 80 patients was calculated based on the following assumptions: two-tailed test, a type I error of 0.01, a power of 90

  2. Radiotherapy QA of the DAHANCA 19 protocol

    DEFF Research Database (Denmark)

    Samsøe, E.; Andersen, E.; Hansen, C. R.;

    2015-01-01

    of 504 Danish patients entered the protocol in 2007-2012. Patients received RT at 5 different oncology centers to a total dose of 66-68Gy, 2Gy/fx, 6 fx/week. For the current QA analysis, total treatment time, CTV coverage, and near-max doses to the spinal cord and brainstem including the corresponding...... concept was introduced in the Danish clinics shortly after 2007. Furthermore, 13 patients (2.6%) were eliminated from the CTV QA due to challenges to extract dose summations (e.g. re-scans and primary/ boost dose plans) from the database. A total of 11 major deviations were recorded. Four major deviations...... in CTV1 dose coverage were due to clinical considerations of the tolerance dose to the spinal cord, thus compromising target dose. Five of the major deviations in total treatment time were related to comorbidities, such as alcohol- or cardiac related matters and hospitalization. The remaining two cases...

  3. Chest magnetic resonance imaging: a protocol suggestion

    Directory of Open Access Journals (Sweden)

    Bruno Hochhegger

    2015-12-01

    Full Text Available Abstract In the recent years, with the development of ultrafast sequences, magnetic resonance imaging (MRI has been established as a valuable diagnostic modality in body imaging. Because of improvements in speed and image quality, MRI is now ready for routine clinical use also in the study of pulmonary diseases. The main advantage of MRI of the lungs is its unique combination of morphological and functional assessment in a single imaging session. In this article, the authors review most technical aspects and suggest a protocol for performing chest MRI. The authors also describe the three major clinical indications for MRI of the lungs: staging of lung tumors; evaluation of pulmonary vascular diseases; and investigation of pulmonary abnormalities in patients who should not be exposed to radiation.

  4. Comparison of different ovarian hyperstimulation protocols efficacy in poor ovarian responders according to the Bologna criteria

    OpenAIRE

    Hu, Linli; Bu, Zhiqin; Guo, Yihong; Su, Yingchun; ZHAI, JUN; Sun, Yingpu

    2014-01-01

    Many protocols have been proposed to improve IVF outcomes for poor ovarian responders. The aim of this study was to explore the relationship between age, ovarian hyperstimulation protocol and IVF/ICSI outcomes in poor ovarian responder (POR) according to the Bologna criteria, and to compare the efficacy of different protocols used in PORs undergoing IVF/ICSI. We retrospectively analyzed clinical data of 4875 IVF/ICSI cycles, including 592 cycles of women diagnosed with POR according to Bologn...

  5. Evaluation of bond strength between glass fiber and resin composite using different protocols for dental splinting

    OpenAIRE

    Amaral R Fabrício; Queiroz C José Renato; Leite P. P. Fabíola; Reskalla N. J. F. Helcio; Rodrigo Furtado de Carvalho; Özcan Mutlu

    2013-01-01

    Context: Many different polymeric materials to chair-side application on pre-impregnated glass fibers (PGF) are available and different protocols are used in clinical procedure. Aims: This study evaluated protocols used for dental splinting on adhesion between PGF and resin. Settings and Design: 42 pair of nano composite resin blocks with (6 × 6 × 8) mm 3 were assigned into seven groups (n=6) and bonded according to the protocol: Gar) adhesive, resin; Ggr) glass fiber, resin; Ggar) glass fibe...

  6. The DOMUS study protocol

    DEFF Research Database (Denmark)

    Nordly, Mie; Benthien, Kirstine Skov; Von Der Maase, Hans;

    2014-01-01

    is a controlled randomized clinical trial with a balanced parallel-group randomization (1:1). The planned sample size is 340 in- and outpatients treated at the Department of Oncology at Copenhagen University Hospital. Patients are randomly assigned either to: a) standard care plus SPC enriched with a...... cancer can be a powerful tool to improve patients' quality of life and support family/caregivers during the disease trajectory. The present study offers a model for achieving optimal delivery of palliative care in the patient's preferred place of care and attempt to clarify challenges. TRIAL REGISTRATION...

  7. Case management in oncology rehabilitation (CAMON: The effect of case management on the quality of life in patients with cancer after one year of ambulant rehabilitation. A study protocol for a randomized controlled clinical trial in oncology rehabilitation

    Directory of Open Access Journals (Sweden)

    Bardheci Katarina

    2011-04-01

    Full Text Available Abstract Background Cancer diseases and their therapies have negative effects on the quality of life. The aim of this study is to assess the effectiveness of case management in a sample of oncological outpatients with the intent of rehabilitation after cancer treatment. Case management wants to support the complex information needs of the patients in addition to the segmented structure of the health care system. Emphasis is put on support for self-management in order to enhance health - conscious behaviour, learning to deal with the burden of the illness and providing the opportunity for regular contacts with care providers. We present a study protocol to investigate the efficacy of a case management in patients following oncology rehabilitation after cancer treatment. Methods The trial is a multicentre, two-arm randomised controlled study. Patients are randomised parallel in either 'usual care' plus case management or 'usual care' alone. Patients with all types of cancer can be included in the study, if they have completed the therapy with chemo- and/or radiotherapy/surgery with curative intention and are expected to have a survival time >1 year. To determine the health-related quality of life the general questionnaire FACT G is used. The direct correlation between self-management and perceived self-efficacy is measured with the Jerusalem & Schwarzer questionnaire. Patients satisfaction with the care received is measured using the Patient Assessment of Chronic Illness Care 5 As (PACIC-5A. Data are collected at the beginning of the trial and after 3, 6 and 12 months. The power analysis revealed a sample size of 102 patients. The recruitment of the centres began in 2009. The inclusion of patients began in May 2010. Discussion Case management has proved to be effective regarding quality of life of patients with chronic diseases. When it comes to oncology, case management is mainly used in cancer treatment, but it is not yet common in the

  8. A comparison of national and international megavoltage calibration protocols

    International Nuclear Information System (INIS)

    Almond lists, describes and compares the following radiation therapy dosimetry protocols and standards of the following groups: Deutsches Institut fuer Normung (DIN), Nordic Association of Clinical Physics (NACP), National Council on Radiation Protection and Measurements (NCRP), Hospital Physicists Association (HPA), American Association of Physics in Medicine (AAPM), Bureau National de Metrologie (BNM), and the Sociedad Espanola de fisica Medica (SEFM)

  9. Warwick Hip Trauma Study: a randomised clinical trial comparing interventions to improve outcomes in internally fixed intracapsular fractures of the proximal femur. Protocol for The WHiT Study

    Directory of Open Access Journals (Sweden)

    Griffin Xavier

    2010-08-01

    Full Text Available Abstract Background Controversy exists regarding the optimal treatment for patients with displaced intracapsular fractures of the proximal femur. The recognised treatment alternatives are arthroplasty and internal fixation. The principal criticism of internal fixation is the high rate of non-union; up to 30% of patients will have a failure of the fixation leading to revision surgery. We believe that improved fracture healing may lead to a decreased rate of failure of fixation. We therefore propose to investigate strategies to both accelerate fracture healing and improve fixation that may significantly improve outcomes after internal fixation of intracapsular femoral fractures. We aim to test the clinical effectiveness of the osteoinductive agent platelet rich plasma and conduct a pilot study of a novel fixed-angle fixation system. Design We have planned a three arm, single centre, standard-of-care controlled, double blinded, pragmatic, randomised clinical trial. The trial will include a standard two-way comparison between platelet-rich plasma and standard-of-care fixation versus standard-of-care fixation alone. In addition there will be a subsidiary pilot arm testing a fixed-angle screw and plate fixation system. Trial Registration Current Controlled Trials ISRCTN49197425

  10. Optimizing 64-slice spiral CT angiography in lower extremity arterial disease with individualized injection protocol

    International Nuclear Information System (INIS)

    Objective: To explore the optimal protocol of the 64-slice spiral CT angiography (CTA) in lower extremity arterial disease. Methods: Forty -eight patients with clinically suspected lower extremity arterial disease underwent GE LightSpeed VCT using individual and traditional injection protocols. The clinical value of CTA was evaluated using DSA as the standard reference. Results: Satisfactory images were obtained from 47 of 48 cases. Images fulfilling clinical diagnostic requirements after appropriate post -procession on workstation were obtained from 1 case. The image quality of the group with the individualized injection protocol was significantly superior to that of the group with the traditional image protocol. The sensitivity and specificity of CTA in detecting middle-grade and severe arterial stenosis were 86.1% and 86.6%, respectively. Conclusion: 64-slice spiral CT angiography is a reliable method for evaluating the lower extremity arterial disease, and is a more ideal method if using individualized injection protocol. (authors)

  11. Improved Authenticated Multi-Key Agreement Protocol

    Institute of Scientific and Technical Information of China (English)

    ZHANG Hua; YUAN Zheng; WEN Qiaoyan

    2006-01-01

    Zhou et al give an attack on Harn's modified authenticated multi-key agreement protocol, and give a protocol that can prevent the unknown key-share attack. The paper points out that the protocol is vulnerable to a concatenation attack. This paper proposes an improved authenticated multi-key agreement protocol which shows how to make Harn's protocol more secure by modifying the signature and verification. And this protocol can escape the concatenation attack.

  12. Session Initiation Protocol Attacks and Challenges

    OpenAIRE

    Keshavarz, Hassan; Sattari, Mohammad Reza Jabbarpour; Noor, Rafidah Md

    2012-01-01

    In recent years, Session Initiation Protocol (SIP) has become widely used in current internet protocols. It is a text-based protocol much like Hyper Text Transport Protocol (HTTP) and Simple Mail Transport Protocol (SMTP). SIP is a strong enough signaling protocol on the internet for establishing, maintaining, and terminating session. In this paper the areas of security and attacks in SIP are discussed. We consider attacks from diverse related perspectives. The authentication schemes are comp...

  13. Assessment of Established Survey Protocols

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — A form and instructions for quickly and briefly assessing a previously prior to 2013 reviewed or approved survey protocol for use as a National or Regional survey...

  14. Automatic Sequencing for Experimental Protocols

    Science.gov (United States)

    Hsieh, Paul F.; Stern, Ivan

    We present a paradigm and implementation of a system for the specification of the experimental protocols to be used for the calibration of AXAF mirrors. For the mirror calibration, several thousand individual measurements need to be defined. For each measurement, over one hundred parameters need to be tabulated for the facility test conductor and several hundred instrument parameters need to be set. We provide a high level protocol language which allows for a tractable representation of the measurement protocol. We present a procedure dispatcher which automatically sequences a protocol more accurately and more rapidly than is possible by an unassisted human operator. We also present back-end tools to generate printed procedure manuals and database tables required for review by the AXAF program. This paradigm has been tested and refined in the calibration of detectors to be used in mirror calibration.

  15. Kyoto Protocol one step closer

    Science.gov (United States)

    Showstack, Randy

    The European Union (EU) could soon decide to ratify the Kyoto Protocol on climate change, following a 4 March meeting of the European Commissions environment council to approve the treaty.European Commission President Romani Prodi said the council's move enables the 15 EU member states to take the steps toward simultaneous ratification together with the commission before 1 June."I urge our partners both in the developed and in the developing countries to also ratify the Kyoto Protocol soon," he said.

  16. Neonatal euthanasia: The Groningen Protocol*

    OpenAIRE

    Vizcarrondo, Felipe E.

    2014-01-01

    For the past thirty years, voluntary euthanasia and physician-assisted suicide of adult patients have been common practice in the Netherlands. Neonatal euthanasia was recently legalized in the Netherlands and the Groningen Protocol (GP) was developed to regulate the practice. Supporters claim compliance with the GP criteria makes neonatal euthanasia ethically permissible. An examination of the criteria used by the Protocol to justify the euthanasia of seriously ill neonates reveals the criter...

  17. Effect of Sitagliptin and Metformin on Prediabetes Progression to Type 2 Diabetes - A Randomized, Double-Blind, Double-Arm, Multicenter Clinical Trial: Protocol for the Sitagliptin and Metformin in PreDiabetes (SiMePreD) Study

    Science.gov (United States)

    2016-01-01

    Background The high prevalence and incidence of type 2 diabetes mellitus (DM), and its associated morbidity and mortality, has prompted growing international interest and effort in the primary prevention of this disease. Primary prevention is possible since type 2 DM is preceded by prediabetes, offering a window opportunity to treat patients, and prevent the emergence of advanced disease. Sitagliptin is an oral dipeptidyl peptidase-IV inhibitor that preserves existing beta cell function and increases beta cell mass. These two effects have been demonstrated both in vitro and in animal studies, and current clinical data show that sitagliptin is safe. Metformin, a biguanide, reduces insulin resistance and inhibits hepatic gluconeogenesis, and has an excellent safety profile. The combination of metformin and sitagliptin, targeting both characteristics of prediabetes (insulin resistance and progressive beta cell degeneration), may potentially slow or halt the progression from prediabetes to type 2 DM. This paper describes the rationale and design of the Sitagliptin and Metformin in PreDiabetes (SiMePreD) study. Objective The aim of this study is to determine the effect of sitagliptin and metformin on progression from prediabetes to type 2 DM. The objectives of the study are to determine the effects of metformin and placebo on glycemic endpoints, the effects of sitagliptin and metformin on glycemic endpoints, the effects of metformin and placebo on incidence of cardiovascular disease and death, and the effects of sitagliptin and metformin on incidence of cardiovascular disease and death. Methods This is a randomized, double-blind, multicenter clinical study that will determine if the combination of metformin and sitagliptin is effective in preventing the progression from prediabetes to type 2 DM. The study will contain two arms (metformin/sitagliptin and metformin/placebo). Primary endpoints include the number of subjects progressing from prediabetes to type 2 DM, the

  18. Secure E-payment Protocol

    Directory of Open Access Journals (Sweden)

    Sattar J Aboud

    2009-11-01

    Full Text Available The vast spreading of information in the last decade has led to greatdevelopment in e-commerce. For instance, e-trade and e-bank are two mainInternet services that implement e-transaction from anyplace in the world. Thishelps merchant and bank to ease the financial transaction process and to giveuser friendly services at any time. However, the cost of workers andcommunications falls down considerably while the cost of trusted authority andprotecting information is increased. E-payment is now one of the most centralresearch areas in e-commerce, mainly regarding online and offline paymentscenarios. In this paper, we will discuss an important e-payment protocol namelyKim and Lee scheme examine its advantages and delimitations, whichencourages the author to develop more efficient scheme that keeping allcharacteristics intact without concession of the security robustness of theprotocol. The suggest protocol employs the idea of public key encryption schemeusing the thought of hash chain. We will compare the proposed protocol with Kimand Lee protocol and demonstrate that the proposed protocol offers moresecurity and efficiency, which makes the protocol workable for real worldservices.

  19. [Studies of biologic activation associated with molecular receptor increase and tumor response in ChL6/L6 protocol patients; Studies in phantoms; Quantitative SPECT; Preclinical studies; and Clinical studies]. DOE annual report, 1994-95

    International Nuclear Information System (INIS)

    The authors describe results which have not yet been published from their associated studies listed in the title. For the first, they discuss Lym-1 single chain genetically engineered molecules, analysis of molecular genetic coded messages to enhance tumor response, and human dosimetry and therapeutic human use radiopharmaceuticals. Studies in phantoms includes a discussion of planar image quantitation, counts coincidence correction, organ studies, tumor studies, and 90Y quantitation with Bremsstrahlung imaging. The study on SPECT discusses attenuation correction and scatter correction. Preclinical studies investigated uptake of 90Y-BrE-3 in mice using autoradiography. Clinical studies discuss image quantitation verses counts from biopsy samples, S factors for radiation dose calculation, 67Cu imaging studies for lymphoma cancer, and 111In MoAb imaging studies for breast cancer to predict 90Y MoAb therapy

  20. Rationale, design, and implementation protocol of the Dutch clinical practice guideline Pain in patients with cancer: a cluster randomised controlled trial with short message service (SMS and interactive voice response (IVR

    Directory of Open Access Journals (Sweden)

    te Boveldt Nienke

    2011-12-01

    Full Text Available Abstract Background One-half of patients with cancer have pain. In nearly one out of two cancer patients with pain, this was undertreated. Inadequate pain control still remains an important problem in this group of patients. Therefore, in 2008 a national, evidence-based multidisciplinary clinical practice guideline 'pain in patients with cancer' has been developed. Yet, publishing a guideline is not enough. Implementation is needed to improve pain management. An innovative implementation strategy, Short Message Service with Interactive Voice Response (SVS-IVR, has been developed and pilot tested. This study aims to evaluate on effectiveness of this strategy to improve pain reporting, pain measurement and adequate pain therapy. In addition, whether the active role of the patient and involvement of caregivers in pain management may change. Methods/design A cluster randomised controlled trial with two arms will be performed in six oncology outpatient clinics of hospitals in the Southeastern region of the Netherlands, with three hospitals in the intervention and three in the control condition. Follow-up measurements will be conducted in all hospitals to study the long-term effect of the intervention. The intervention includes training of professionals (medical oncologists, nurses, and general practitioners and SMS-IVR to report pain in patients with cancer to improve pain reporting by patients, pain management by medical oncologists, nurses, and general practitioners, and decrease pain intensity. Discussion This innovative implementation strategy with technical tools and the involvement of patients, may enhance the use of the guideline 'pain in patients with cancer' for pain management. Short Message Service alerts may serve as a tool to support self-management of patients. Therefore, the SMS-IVR intervention may increase the feeling of having control over one's life. Trail registration Netherlands Trial Register (NTR: NTR2739

  1. Clinical Allograft Islets Post-transplant 1 Year for Type 1 Diabetes Mellitus with A Modified Edmonton Protocol%同种异体胰岛细胞移植治疗1型糖尿病的护理

    Institute of Scientific and Technical Information of China (English)

    张雯

    2015-01-01

    目的:总结同种异体胰岛细胞移植治疗1型糖尿病的护理研究。方法按JDRF标准筛选3例1型糖尿病患者(T1DM),并实施同种异体胰岛细胞移植。在GMP实验室内以Liberase 酶消化胰腺器官、COBE 2991细胞分离机分离、连续密度梯度纯化,获取高纯度与高活性的胰岛细胞。培养12h后,检测其达到移植标准,再经皮穿刺肝脏门静脉主干,经门静脉将胰岛细胞匀速移植到肝脏内。术后应用各种护理方法,密切观察病情变化和各种并发症的变化。结果2例完全脱离胰岛素治疗,1例胰岛素用量较术前减少60%以上。术后血糖稳定,C肽、糖化血红蛋白在正常范围,肾功能得以改善,无移植并发症、以及低血糖发作,患者掌握了术后自我管理的方法,总结出了个体化的护理经验。结论患者护理效果满意,初步建立同种异体胰岛细胞移植治疗1型糖尿病一整套护理方法。%Objective To investigate the pancreatic islet cell isolation technology,quality standards,and allograft islet cell transplantation in the treatment of type 1 diabetes safety and effectiveness. Methods According to Juvenile Diabetes Research Foundation (JDRF) standard screening method,three cases of type 1 diabetes (T1DM) were selected as allograft islet cells recipi-ents. Using Liberase enzyme digested pancreatic organs,COBE 2991 cell separator,and discontinuous density gradient purification-to obtained high purity and high activity of islet cells. All these procedures were conducted in our GMP facilities. Cultured after 12h,testing islets reached transplant standards,then performed percutaneous hepatic portal vein trunk of the recipients,islet cells were through the portal vein into the recipient liver site. After islet transplantation,using a modified Edmonton immunosuppressive protocol controlled rejection,and monitored of blood glucose,C peptide and glycate hemoglobin level changes regularly for 1-year followed

  2. Development of a new DNA extraction protocol for PFGE typing of Mycobacterium tuberculosis complex.

    Science.gov (United States)

    Ghodousi, Arash; Arash, Ghodousi A; Vatani, S; Darban-Sarokhalil, Davood; Omrani, Maryam; Fooladi, A; Fooladi, Aa; Khosaravi, A; Khosaravi, Ad; Feizabadi, Mohammad Mehdi

    2012-03-01

    A modified pulsed-field gel electrophoresis (PFGE) protocol was developed and applied to clinical isolates of Mycobacterium tuberculosis complex to reduce the cost of using lyticase. This protocol reduces the expense of PFGE typing of Mycobacterium tuberculosis complex as it removes the use of lyticase during the spheroplast formation from these bacteria. PMID:22783461

  3. Agonist versus antagonist protocol in induction of ovulation and its outcome

    Directory of Open Access Journals (Sweden)

    Prasad Lele

    2016-06-01

    Conclusions: The GnRH antagonist therefore seems to be a more patient friendly protocol for the first choice in ART cycle with lower incidence of side effects and similar pregnancy rate. It is also time saving and simple protocol with good clinical outcome. [Int J Reprod Contracept Obstet Gynecol 2016; 5(6.000: 1748-1753

  4. Monoclonal antibodies technology. Protocols

    International Nuclear Information System (INIS)

    Full text: Immunization. The first step in preparing useful monoclonal antibodies (MAbs) is to immunize an animal (Balb/c for example) with an appropriate antigen. Methods (only for soluble antigen): Solubilize selected antigen in Phosphate buffer solution (PBS) at pH 7.2-7.4, ideally at a final concentration per animal between 10 to 50 μg/ml. It is recommended that the antigen under consideration be incorporated into the emulsion adjuvants in 1:1 volumetric relation. We commonly use Frend's adjuvant (FA) to prepared immunized solution. The first immunization should be prepared with complete FA, and the another could be prepared with incomplete FA. It is recommended to inject mice with 0.2 ml intraperitoneal (ip) or subcutaneous (sc). Our experience suggests the sc route is the preferred route. A minimum protocol for immunizing mice to generate cells for preparing hybridomas is s follows: immunize sc on day 0, boost sc on day 21, take a trial bleeding on day 26; if antibody titters are satisfactory, boost ip on day 35 with antigen only, and remove the spleen to obtain cells for fusion on day 38. Fusion protocol. The myeloma cell line we are using is X63 Ag8.653. At the moment of fusion myeloma cells need a good viability (at least a 95%). 1. Remove the spleen cells from immunized mice using sterile conditions. An immune spleen should yield between 7 a 10x107 nucleated cells. 2. Place the spleen in 20 ml of serum-free RPMI 1640 in a Petri dish. Using a needle and syringe, inject the spleen with medium to distend and disrupt the spleen stroma and free the nucleated cells. 3. Flush the cell suspension with a Pasteur pipet to disperse clumps of cells. 4. Centrifuge the spleen cell suspension at 250g for 10 min. Resuspend the pellet in serum-free RPMI 1640. Determine cell concentration using Neuhabuer chamber. 5. Mix the myeloma cells and spleen cells in a conical 50-ml tube in serum-free RPMI 1640, 1 x107 spleen cells to 1x106 myeloma cells (ratio 10:1). Centrifuge

  5. Open reduction and internal fixation versus casting for highly comminuted and intra-articular fractures of the distal radius (ORCHID: protocol for a randomized clinical multi-center trial

    Directory of Open Access Journals (Sweden)

    Seiler Christoph

    2011-03-01

    Full Text Available Abstract Background Fractures of the distal radius represent the most common fracture in elderly patients, and often indicate the onset of symptomatic osteoporosis. A variety of treatment options is available, including closed reduction and plaster casting, K-wire-stabilization, external fixation and open reduction and internal fixation (ORIF with volar locked plating. The latter is widely promoted by clinicians and hardware manufacturers. Closed reduction and cast stabilization for six weeks is a simple, convenient, and ubiquitously available intervention. In contrast, ORIF requires hospitalization, but allows for functional rehabilitation. Given the lack of randomized controlled trials, it remains unclear whether ORIF leads to better functional outcomes one year after injury than closed reduction and casting. Methods/Design ORCHID (Open reduction and internal fixation versus casting for highly comminuted intra-articular fractures of the distal radius is a pragmatic, randomized, multi-center, clinical trial with two parallel treatment arms. It is planned to include 504 patients in 15 participating centers throughout Germany over a three-year period. Patients are allocated by a central web-based randomization tool. The primary objective is to determine differences in the Short Form 36 (SF-36 Physical Component Score (PCS between volar locked plating and closed reduction and casting of intraarticular, comminuted distal radius fractures in patients > 65 years of age one year after the fracture. Secondary outcomes include differences in other SF-36 dimensions, the EuroQol-5D questionnaire, the Disability of the Arm, Shoulder, and Hand (DASH instrument. Also, the range of motion in the affected wrist, activities of daily living, complications (including secondary ORIF and revision surgery, as well as serious adverse events will be assessed. Data obtained during the trial will be used for later health-economic evaluations. The trial architecture

  6. Do randomized clinical trials with inadequate blinding report enhanced placebo effects for intervention groups and nocebo effects for placebo groups? A protocol for a meta-epidemiological study of PDE-5 inhibitors

    Directory of Open Access Journals (Sweden)

    Feys Frederik

    2012-11-01

    Full Text Available Abstract Background Patients’ expectations of treatment effects may contribute to positive (placebo and negative (nocebo outcomes. The effect of patient expectations may be pronounced in subjectively assessed conditions, such as male erectile dysfunction. The aim of this project is to examine the magnitude of expectancy in trials of phosphodiesterase-5 inhibitors. We hypothesize that randomized controlled trials with inadequate blinding will report enhanced placebo effects for intervention groups and nocebo effects for placebo groups, compared with adequately blinded studies. Methods/design We will quantify the magnitude of expectancy by comparing the effect estimates of trials with inadequate and adequate blinding. Blinding will be assessed using four domains from the Cochrane ‘risk-of-bias’ tool: allocation concealment; blinding of patient; caregiver; and outcome assessor. Our secondary aim is to identify factors that can modify expectations, such as prior experience with the intervention and drug side effects. We will perform an electronic search using a combination of controlled vocabulary and free text words in the following databases: MEDLINE, EMBASE, CENTRAL, and a clinical trials register. We will include randomized controlled trials, with either parallel or crossover design, that compare one phosphodiesterase-5 inhibitor with a placebo. The study’s primary aim should be to investigate the efficacy of phosphodiesterase-5 inhibitors for treating male erectile dysfunction. Screening will take place at two levels: abstracts and titles, followed by full text reports. Two reviewers will independently extract data on the primary outcome and assess risk of bias. We will meta-analyze treatment effects, if appropriate, to assess the magnitude of enhanced placebo effects and nocebo effects in intervention and placebo groups, respectively. We will explore possible mediators of placebo and nocebo effects with subgroup and meta

  7. Training family physicians and residents in family medicine in shared decision making to improve clinical decisions regarding the use of antibiotics for acute respiratory infections: protocol for a clustered randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Frémont Pierre

    2011-01-01

    and physicians, intention to engage in SDM in future clinical encounters will be assessed. Intention-to-treat analyses will be applied and account for the nested design of the trial will be taken into consideration. Discussion DECISION+2 has the potential to reduce antibiotics use for ARIs by priming physicians and patients to share decisional process and empowering patients to make informed, value-based decisions. Trial Registration ClinicalTrials.gov: NCT01116076

  8. A mixed methods study to evaluate the clinical and cost-effectiveness of a self-managed exercise programme versus usual physiotherapy for chronic rotator cuff disorders: protocol for the SELF study

    Directory of Open Access Journals (Sweden)

    Littlewood Chris

    2012-04-01

    Full Text Available Abstract Background Shoulder pain is the third most common reason for consultation with a physiotherapist and up to 26% of the general population might be expected to experience an episode at any one time. Disorders of the shoulder muscles and tendons (rotator cuff are thought to be the commonest cause of this pain. The long-term outcome is frequently poor despite treatment. This means that many patients are exposed to more invasive treatment, e.g. surgery, and/or long-term pain and disability. Patients with this disorder typically receive a course of physiotherapy which might include a range of treatments. Specifically the value of exercise against gravity or resistance (loaded exercise in the treatment of tendon disorders is promising but appears to be under-used. Loaded exercise in other areas of the body has been favourably evaluated but further investigation is needed to evaluate the impact of these exercises in the shoulder and particularly the role of home based or supervised exercise versus usual treatment requiring clinic attendance. Methods/Design A single-centre pragmatic unblinded parallel group randomised controlled trial will evaluate the effectiveness of a self-managed loaded exercise programme versus usual clinic based physiotherapy. A total of 210 study participants with a primary complaint of shoulder pain suggestive of a rotator cuff disorder will be recruited from NHS physiotherapy waiting lists and allocated to receive a programme of self-managed exercise or usual physiotherapy using a process of block randomisation with sealed opaque envelopes. Baseline assessment for shoulder pain, function and quality of life will be undertaken with the Shoulder Pain & Disability Index, the Patient Specific Functional Scale and the SF-36. Follow-up evaluations will be completed at 3, 6 and 12 months by postal questionnaire. Both interventions will be delivered by NHS Physiotherapist’s. An economic analysis will be conducted from an

  9. A simple method for estimating the effective dose in dental CT. Conversion factors and calculation for a clinical low-dose protocol; Eine einfache Methode zur Abschaetzung der effektiven Dosis bei Dental-CT. Konversionsfaktoren und exemplarische Berechnung fuer ein klinisches Low-Dose-Protokoll

    Energy Technology Data Exchange (ETDEWEB)

    Homolka, P.; Kudler, H.; Nowotny, R. [Inst. fuer Biomedizinische Technik und Physik, Univ. Wien (Austria); Gahleitner, A. [Wien Univ. (Austria). Abt. fuer Osteologie; Wien Univ. (Austria). Zahn-, Mund- und Kieferheilkunde

    2001-06-01

    An easily appliable method to estimate effective dose including in its definition the high radio-sensitivity of the salivary glands from dental computed tomography is presented. Effective doses were calculated for a markedly dose reduced dental CT protocol as well as for standard settings. Data are compared with effective doses from the literature obtained with other modalities frequently used in dental care. Methods: Conversion factors based on the weighted Computed Tomography Dose Index were derived from published data to calculate effective dose values for various CT exposure settings. Results: Conversion factors determined can be used for clinically used kVp settings and prefiltrations. With reduced tube current an effective dose for a CT examination of the maxilla of 22 {mu}Sv can be achieved, which compares to values typically obtained with panoramic radiography (26 {mu}Sv). A CT scan of the mandible, respectively, gives 123 {mu}Sv comparable to a full mouth survey with intraoral films (150 {mu}Sv). Conclusion: For standard CT scan protocols of the mandible, effective doses exceed 600 {mu}Sv. Hence, low dose protocols for dental CT should be considered whenever feasable, especially for paediatric patients. If hard tissue diagnoses is performed, the potential of dose reduction is significant despite the higher image noise levels as readability is still adequate. (orig.) [German] Eine Methode, die eine einfache Bestimmung der effektiven Dosis bei Dental-CT unter Beruecksichtigung der Strahlensensitivitaet der Gl. parotis und der Gl. submandibularis - sowohl bei Standard- als auch bei dosisreduzierten Protokollen - ermoeglicht, wird beschrieben. Weiters wird die effektive Dosis eines klinisch verwendeten Low-Dose-Protokolles abgeschaetzt und mit den haeufigsten dentalradiologischen Untersuchungsverfahren verglichen. Methoden: Aus publizierten effektiven Dosen fuer Maxilla und Mandibula Scans wurden Konversionsfaktoren ermittelt, mit deren Hilfe fuer abweichende

  10. LigaSure Impact™ versus conventional dissection technique in pylorus-preserving pancreatoduodenectomy in clinical suspicion of cancerous tumours on the head of the pancreas: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Müller-Stich Beat P

    2011-06-01

    Full Text Available Abstract Background The pp-Whipple procedure requires extensive preparation. The conventional preparation technique is done with scissors for dissection and ligatures, and with clips and sutures for hemostasis. This procedure is very time-consuming and requires numerous changes of instruments. The LigaSure™ device allows dissection and hemostasis for preparation with one instrument. Up to now there has been no comparison of the two techniques with regard to operating time and the patients' outcome. It is still unclear which technique has the optimal benefit/risk ratio for the patient. Methods/Design A single-center, randomized, single-blinded, controlled superiority trial to compare two different techniques for dissection in a pp-Whipple procedure. 102 patients will be included and randomized pre-operatively. All patients aged 18 years or older scheduled for primary elective pp-Whipple procedure who signed the informed consent will be included. The primary endpoint is the operating time of the randomized technique. Control Intervention: Conventional dissection technique; experimental intervention: LigaSureTM dissection technique. Duration of study: Approximately 15 months; follow up time: 3 years. The trial is registered at German ClinicalTrials Register (DRKS00000166.

  11. Protocols.io: Virtual Communities for Protocol Development and Discussion.

    Science.gov (United States)

    Teytelman, Leonid; Stoliartchouk, Alexei; Kindler, Lori; Hurwitz, Bonnie L

    2016-08-01

    The detailed know-how to implement research protocols frequently remains restricted to the research group that developed the method or technology. This knowledge often exists at a level that is too detailed for inclusion in the methods section of scientific articles. Consequently, methods are not easily reproduced, leading to a loss of time and effort by other researchers. The challenge is to develop a method-centered collaborative platform to connect with fellow researchers and discover state-of-the-art knowledge. Protocols.io is an open-access platform for detailing, sharing, and discussing molecular and computational protocols that can be useful before, during, and after publication of research results. PMID:27547938

  12. Recovery of Unrelated Donors of Peripheral Blood Stem Cells versus Recovery of Unrelated Donors of Bone Marrow: A Prespecified Analysis from the Phase III Blood and Marrow Transplant Clinical Trials Network Protocol 0201.

    Science.gov (United States)

    Burns, Linda J; Logan, Brent R; Chitphakdithai, Pintip; Miller, John P; Drexler, Rebecca; Spellman, Stephen; Switzer, Galen E; Wingard, John R; Anasetti, Claudio; Confer, Dennis L

    2016-06-01

    We report a comparison of time to recovery, side effects, and change in blood counts from baseline to after donation from unrelated donors who participated in the Blood and Marrow Transplant Clinical Trials Network phase III randomized, multicenter trial (0201) in which donor-recipient pairs were randomized to either peripheral blood stem cell (PBSC) or bone marrow (BM) donation. Of the entire cohort, 262 donated PBSC and 264 donated BM; 372 (71%) donors were from domestic and 154 (29%) were from international centers (145 German and 9 Canadian). PBSC donors recovered in less time, with a median time to recovery of 1 week compared with 2.3 weeks for BM donors. The number of donors reporting full recovery was significantly greater for donors of PBSC than of BM at 1, 2, and 3 weeks and 3 months after donation. Multivariate analysis showed that PBSC donors were more likely to recover at any time after donation compared with BM donors (hazard ratio, 2.08; 95% confidence interval [CI], 1.73 to 2.50; P ratio, 1.13; 95% CI, .74 to 1.74; P = .556). Blood counts were affected by product donated, with greater mean change from baseline to after donation for white blood cells, neutrophils, mononuclear cells, and platelets in PBSC donors whereas BM donors experienced a greater mean change in hemoglobin. This analysis provided an enhanced understanding of donor events as product donated was independent of physician bias or donor preference. PMID:27013014

  13. Superselection rules and quantum protocols

    International Nuclear Information System (INIS)

    We show that superselection rules do not enhance the information-theoretic security of quantum cryptographic protocols. Our analysis employs two quite different methods. The first method uses the concept of a reference system--in a world subject to a superselection rule, unrestricted operations can be simulated by parties who share access to a reference system with suitable properties. By this method, we prove that if an n-party protocol is secure in a world subject to a superselection rule, then the security is maintained even if the superselection rule is relaxed. However, the proof applies only to a limited class of superselection rules, those in which the superselection sectors are labeled by unitary irreducible representations of a compact symmetry group. The second method uses the concept of the format of a message sent between parties--by verifying the format, the recipient of a message can check whether the message could have been sent by a party who performed charge-conserving operations. By this method, we prove that protocols subject to general superselection rules (including those pertaining to non-Abelian anyons in two dimensions) are no more secure than protocols in the unrestricted world. However, the proof applies only to two-party protocols. Our results show in particular that, if no assumptions are made about the computational power of the cheater, then secure quantum bit commitment and strong quantum coin flipping with arbitrarily small bias are impossible in a world subject to superselection rules

  14. 21 CFR 1301.18 - Research protocols.

    Science.gov (United States)

    2010-04-01

    ..., DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES Registration § 1301.18 Research protocols. (a) A protocol... security provisions (as proscribed in paragraph (a)(2)(vi) of this section for a research protocol) to, and... be in lieu of a research protocol to the Administration as required in paragraph (a) of this...

  15. Clinical and cost-effectiveness of internal limiting membrane peeling for patients with idiopathic full thickness macular hole. Protocol for a Randomised Controlled Trial: FILMS (Full-thickness macular hole and Internal Limiting Membrane peeling Study

    Directory of Open Access Journals (Sweden)

    Cook Jonathan

    2008-11-01

    role of ILM peeling in FTMH surgery. Trial registration This trial is registered with Current Controlled Trials ISRCTN number 33175422 and Clinical Trials.gov identifier NCT00286507.

  16. Emergency department radiation accident protocol.

    Science.gov (United States)

    Leonard, R B; Ricks, R C

    1980-09-01

    Every emergency department faces the potential problem of handling one or more victims of a radiation accident. While emergency departments near nuclear power plants or isotope production laboratories probably have a detailed protocol for such emergencies, a similar protocol is needed for the emergency department that may have to handle an isolated event, such as a vehicular accident that spills radioactive material and contaminates passengers or bystanders. This communication attempts to answer that need, presenting a step-by-step protocol for decontamination of a radiation victim, the rationale on which each step is based, a list of needed supplies, and a short summary of decorporation procedures that should be started in the emergency department. PMID:7425419

  17. Cryptographie Quantique : Protocoles et Graphes

    OpenAIRE

    Javelle, Jérôme

    2014-01-01

    Je souhaite réaliser un modèle théorique optimal pour les protocoles de partage de secret quantique basé sur l'utilisation des états graphes. Le paramètre représentatif d'un partage de secret à seuil est, entre autres la taille du plus grand ensemble de joueurs qui ne peut pas accéder au secret. Je souhaite donc trouver un famille de protocoles pour laquelle ce paramètre est le plus petit possible. J'étudie également les liens entre les protocoles de partage de secret quantique et des famille...

  18. The Geneva Protocol of 1925

    International Nuclear Information System (INIS)

    This paper reports that when President Gerald Ford signed the instruments of ratification for the Geneva Protocol of 1925 on January 22, 1975, a tortured, half-century-long chapter in U.S. arms control policy was brought to a close. Fifty years earlier, at the Geneva Conference for the Control of the International Trade in Arms, Munitions and Implements of War, the United States had played a key role in drafting and reaching agreement on the Protocol for the Prohibition of the Use in War of Asphyxiating, Poisonous or Other Gases and of Bacteriological Methods of Warfare. The protocol, signed by thirty nations, including the United States, on June 17, 1925, prohibits the use in war of asphyxiating, poisonous or other gases, and of all analogous liquids, materials or devices as well as the use of bacteriological methods of warfare

  19. Analysis of the Transport Layer Security protocol

    OpenAIRE

    Firing, Tia Helene

    2010-01-01

    In this master thesis we have presented a security analysis of the TLS protocol with particular emphasis on the recently discovered renegotiation attack. From our security proof we get that the Handshake protocol with renegotiation, including the fix from IETF, is secure, and hence not vulnerable to the renegotiation attack anymore. We have also analysed the Handshake protocol with session resumption, and the Application data protocol together with the Record protocol. Both of these prot...

  20. Analyzing security of Authenticated Routing Protocol (ARAN)

    OpenAIRE

    Seema Mehla; Bhawna Gupta; Preeti Nagrath

    2010-01-01

    Ad hoc network allow nodes to communicate beyond their direct wireless transmission range by introducing cooperation in mobile computer (nodes). Many proposed routing protocol for ad hoc network operate in an ad hoc fashion, as on demand routing protocol often have low overhead and faster reaction time than other type of routingbased on periodic protocol. However variety of attacks targeting routing protocol have been identified. By attacking the routing protocol attacker can absorb network t...

  1. Optimistic Non-repudiation Protocol Analysis

    OpenAIRE

    Santos Santiago, Judson; Vigneron, Laurent

    2007-01-01

    Non-repudiation protocols with session labels have a number of vulnerabilities. Recently Cederquist, Corin and Dashti have proposed an optimistic non-repudiation protocol that avoids altogether the use of session labels. We have specified and analysed this protocol using an extended version of the AVISPA Tool and one important fault has been discovered. We describe the protocol, the analysis method, show two attack traces that exploit the fault and propose a correction to the protocol.

  2. The Kyoto protocol development; La viabilite du protocole de Kyoto

    Energy Technology Data Exchange (ETDEWEB)

    Cooper, R. [Harvard Univ., Barrow, AK (United States); Guesneris, R. [College de France, 75 - Paris (France)

    2002-04-01

    From the author R. Cooper point of view the Kyoto Protocol is a flawed concept. The reasons for dropping Kyoto are presented in this paper insisting that rejecting Kyoto not means to imply that global climate change is not a serious problem. After a presentation of the US policy facing the Climatic Change, some concluding propositions are proposed. (A.L.B.)

  3. Additional protocol experience in Romania

    International Nuclear Information System (INIS)

    Full text: National Commission for Nuclear Activities Control (CNCAN) is the national regulatory body with regulation, authorization and control responsibilities. CNCAN has the right and obligation to ensure that safeguards are applied, in accordance with the terms of the safeguards agreement, on all source or special fissionable material in all peaceful nuclear activities within the State, under its jurisdiction or carried out under its control anywhere, for the exclusive purpose of verifying that such material is not diverted to nuclear weapons or other nuclear explosive devices. CNCAN has built a strong primary and secondary legislation in order to have a strong legal framework to fulfill the NPT, Safeguards Agreement and Additional Protocol requirements. In respect of the non-proliferation issues CNCAN has as a major goal to strengthen the effectiveness and to improve the efficiency of the safeguards system. Also closer co-operation between the IAEA and CNCAN as coordinator of the national system of accounting for and control of nuclear material has been developed by organizing international and national seminars on the implementation of safeguards and the additional protocol. After the entry into force of the Additional Protocol, CNCAN prepared appropriate declarations and answers to the relevant IAEA questions in order to obtain a drawn conclusion of the absence of undeclared nuclear material and nuclear activities within Romania territory. The IAEA evaluated in Romania not only the results of its nuclear material related activities under the Safeguards Agreement but also the results of its broader, more qualitative, evaluation and verification activities under the Additional Protocol. CNCAN assured that the IAEA inspectors have complementary access according to the Additional Protocol as requested in accordance with the provisions of the Safeguards Agreement and the Additional Protocol and cooperated in resolving in a timely manner, any questions or

  4. Sample Size Estimation in Clinical Trial

    OpenAIRE

    Tushar Vijay Sakpal

    2010-01-01

    Every clinical trial should be planned. This plan should include the objective of trial, primary and secondary end-point, method of collecting data, sample to be included, sample size with scientific justification, method of handling data, statistical methods and assumptions. This plan is termed as clinical trial protocol. One of the key aspects of this protocol is sample size estimation. The aim of this article is to discuss how important sample size estimation is for a clinical trial, and a...

  5. Standardized CT protocols and nomenclature: better, but not yet there

    International Nuclear Information System (INIS)

    Radiation dose associated with CT is an important safety concern in patient care, especially in children. Technical advancements in multidetector-row CT scanner technology offer several advantages for clinical applications; these advancements have considerably increased CT utilization and enhanced the complexity of CT scanning protocols. Furthermore there are several scan manufacturers spearheading these technical advancements, leading to different commercial names causing confusion among the users, especially at imaging sites with scanners from different vendors. Several scientific studies and the National Council on Radiation Protection and Measurements (NCRP) have shown variation in CT radiation doses for same body region and similar scanning protocols. Therefore there is a need for standardization of scanning protocols and nomenclature of scan parameters. The following material reviews the status and challenges in standardization of CT scanning and nomenclature. (orig.)

  6. The Activity of Antimicrobial Surfaces Varies by Testing Protocol Utilized

    Science.gov (United States)

    Campos, Matias D.; Zucchi, Paola C.; Phung, Ann; Leonard, Steven N.; Hirsch, Elizabeth B.

    2016-01-01

    Background Contaminated hospital surfaces are an important source of nosocomial infections. A major obstacle in marketing antimicrobial surfaces is a lack of efficacy data based on standardized testing protocols. Aim We compared the efficacy of multiple testing protocols against several “antimicrobial” film surfaces. Methods Four clinical isolates were used: one Escherichia coli, one Klebsiella pneumoniae, and two Staphylococcus aureus strains. Two industry methods (modified ISO 22196 and ASTM E2149), a “dried droplet”, and a “transfer” method were tested against two commercially available antimicrobial films, one film in development, an untreated control, and a positive (silver) control film. At 2 (only ISO) and 24 hours following inoculation, bacteria were collected from film surfaces and enumerated. Results Compared to untreated films in all protocols, there were no significant differences in recovery on either commercial brand at 2 or 24 hours after inoculation. The silver surface demonstrated significant microbicidal activity (mean loss 4.9 Log10 CFU/ml) in all methods and time points with the exception of 2 hours in the ISO protocol and the transfer method. Using our novel droplet method, no differences between placebo and active surfaces were detected. The surface in development demonstrated variable activity depending on method, organism, and time point. The ISO demonstrated minimal activity at 2 hours but significant activity at 24 hours (mean 4.5 Log10 CFU/ml difference versus placebo). The ASTEM protocol exhibited significant differences in recovery of staphylococci (mean 5 Log10 CFU/ml) but not Gram-negative isolates (10 fold decrease). Minimal activity was observed with this film in the transfer method. Conclusions Varying results between protocols suggested that efficacy of antimicrobial surfaces cannot be easily and reproducibly compared. Clinical use should be considered and further development of representative methods is needed. PMID

  7. Bundle Security Protocol for ION

    Science.gov (United States)

    Burleigh, Scott C.; Birrane, Edward J.; Krupiarz, Christopher

    2011-01-01

    This software implements bundle authentication, conforming to the Delay-Tolerant Networking (DTN) Internet Draft on Bundle Security Protocol (BSP), for the Interplanetary Overlay Network (ION) implementation of DTN. This is the only implementation of BSP that is integrated with ION.

  8. Symbolic Analysis of Cryptographic Protocols

    DEFF Research Database (Denmark)

    Dahl, Morten

    concrete protocol by Blumberg et al. using one-way functions and commitments for providing various location based vehicle services, and report on our ndings and experience of carrying out its analysis using the ProVerif tool. Third, we make an abstract model of the powerful simulation-based Universally...

  9. A Student Teamwork Induction Protocol

    Science.gov (United States)

    Kamau, Caroline; Spong, Abigail

    2015-01-01

    Faulty group processes have harmful effects on performance but there is little research about intervention protocols to pre-empt them in higher education. This naturalistic experiment compared a control cohort with an inducted cohort. The inducted cohort attended a workshop, consultations, elected a leader and used tools (a group log and group…

  10. About models of security protocols

    OpenAIRE

    Comon-Lundh, Hubert

    2008-01-01

    In this paper, mostly consisting of definitions, we revisit the models of security protocols: we show that the symbolic and the computational models (as well as others) are instances of a same generic model. Our definitions are also parametrized by the security primitives, the notion of attacker and, to some extent, the process calculus.

  11. Recursive Ping-Pong Protocols

    DEFF Research Database (Denmark)

    Huttel, Hans; Srba, Jiri

    2004-01-01

    This paper introduces a process calculus with recursion which allows us to express an unbounded number of runs of the ping-pong protocols introduced by Dolev and Yao. We study the decidability issues associated with two common approaches to checking security properties, namely reachability analysis...

  12. The Kyoto Protocol and China

    Institute of Scientific and Technical Information of China (English)

    佘巧云

    2005-01-01

    The kyoto Protocol is an agreement to the United Nations Framework Convention on CLimate Change (UNFCCC)2,an international treaty on global warming .It is a legally binding agreement under which industrialized countries will reduce their collective emissions of greenhouse gases by an average of 5.2% compared to the level of 1990 during the 2008-12 period.

  13. Kyoto protocol on climate change

    International Nuclear Information System (INIS)

    This article reports a short overview of main points of Kyoto protocol to United Nations Framework Convention on climate Change and of some options still to be defined, evolutions of Italian emissions with respect to other European countries, check of decree by inter ministerial committee on economic planning on national plan to reduce emissions

  14. Performance Evaluation of Security Protocols

    DEFF Research Database (Denmark)

    Bodei, Chiara; Buchholtz, Mikael; Curti, Michele;

    2005-01-01

    We use a special operational semantics which drives us in inferring quantitative measures on systems describing cryptographis cryptographic protocols. We assign rates to transitions by only looking at these labels. The rates reflect the distributed architecture running applications and the use of...... possibly different cryptosystems. We then map transition systems to Markov chains and evaluate performance of systems, using standard tools....

  15. Performance Evaluation of Security Protocols

    DEFF Research Database (Denmark)

    Bodei, Chiara; Buchholtz, Mikael; Curti, Michele; Degano, Pierpablo; Nielson, Flemming; Nielson, Hanne Riis; Priami, Corrado

    We use a special operational semantics which drives us in inferring quantitative measures on systems describing cryptographis cryptographic protocols. We assign rates to transitions by only looking at these labels. The rates reflect the distributed architecture running applications and the use of...

  16. Petri Nets in Cryptographic Protocols

    DEFF Research Database (Denmark)

    Crazzolara, Federico; Winskel, Glynn

    2001-01-01

    A process language for security protocols is presented together with a semantics in terms of sets of events. The denotation of process is a set of events, and as each event specifies a set of pre and postconditions, this denotation can be viewed as a Petri net. By means of an example we illustrate...

  17. Protocol biopsies for renal transplantation

    Directory of Open Access Journals (Sweden)

    Rush David

    2010-01-01

    Full Text Available Protocol biopsies in renal transplantation are those that are procured at predetermined times post renal transplantation, regardless of renal function. These biopsies have been useful to study the natural history of the transplanted kidney as they have detected unexpected - i.e. "subclinical" pathology. The most significant subclinical pathologies that have been detected with protocol biopsies have been acute lesions, such as cellular and antibody mediated rejection, and chronic lesions, such as interstitial fibrosis and tubular atrophy, and transplant glomerulopathy. The potential benefit of early recognition of the above lesions is that their early treatment may result in improved long-term outcomes. Conversely, the identification of normal histology on a protocol biopsy, may inform us about the safety of reduction in overall immunosuppression. Our centre, as well as others, is attempting to develop non-invasive methods of immune monitoring of renal transplant patients. However, we believe that until such methods have been developed and validated, the protocol biopsy will remain an indispensable tool for the complete care of renal transplant patients.

  18. Improved Secure Address Resolution Protocol

    OpenAIRE

    Abhishek Samvedi; Sparsh Owlak; Vijay Kumar Chaurasia

    2014-01-01

    In this paper, an improved secure address resolution protocol is presented where ARP spoofing attack is prevented. The proposed methodology is a centralised methodology for preventing ARP spoofing attack. In the proposed model there is a central server on a network or subnet which prevents ARP spoofing attack.

  19. Session Initiation Protocol Attacks and Challenges

    CERN Document Server

    Keshavarz, Hassan; Noor, Rafidah Md

    2012-01-01

    In recent years, Session Initiation Protocol (SIP) has become widely used in current internet protocols. It is a text-based protocol much like Hyper Text Transport Protocol (HTTP) and Simple Mail Transport Protocol (SMTP). SIP is a strong enough signaling protocol on the internet for establishing, maintaining, and terminating session. In this paper the areas of security and attacks in SIP are discussed. We consider attacks from diverse related perspectives. The authentication schemes are compared, the representative existing solutions are highlighted, and several remaining research challenges are identified. Finally, the taxonomy of SIP threat will be presented.

  20. Novel analysis and improvement of Yahalom protocol

    Institute of Scientific and Technical Information of China (English)

    CHEN Chun-ling; YU Han; L(U) Heng-shan; WANG Ru-chuan

    2009-01-01

    The modified version of Yahalom protocol improved by Burrows, Abradi, and Needham (BAN) still has security drawbacks. This study analyzed such flaws in a detailed way from the point of strand spaces, which is a novel method of analyzing protocol's security. First, a mathematical model of BAN-Yahalom protocol is constructed. Second, penetrators' abilities are restricted with a rigorous and formalized definition. Moreover, to increase the security of this protocol against potential attackers in practice, a further improvement is made to the protocol. Future application of this re-improved protocol is also discussed.

  1. Effective dose comparison between stitched and single FOV in CBCT protocols for complete dental arcade

    International Nuclear Information System (INIS)

    Objective: The objective of this study was to assess and compare protocols with a single field of view and multiple stitched field of view with a similar clinical purpose by means of effective dose value. Materials and methods: Measurements of absorbed dose were performed with thermoluminescent dosemeters inserted in the position of organs/tissues of a female anthropomorphic phantom and from these values the effective dose was calculated, utilizing weighting factor tissue-ICRP 103 (2007). Results: The results obtained in this study for effective dose are within the range of 43.1 µSv and 111.5 µSv for equipment using protocols with single FOV and in the range of 44.5 µSv and 236.2 µSv for equipments that using protocols with stitched field of view. Conclusions: In terms of the value of effective dose, stitched FOV protocols do not have any advantage over the single field of view protocols. This results suggest the necessity for knowledge of the exposure parameters and effective dose values associated with each image protocol. - Highlights: • The study relies on the comparison of two protocols with similar goals of CBCT: stitched protocols and single protocols. • The stitched FOV protocol is more specific and it is good option when want imaging only of some dental units. • In relation the effective dose, single FOV protocols presents advantage over the stitched FOV protocols. • Know the exposure parameters and effective dose values associated with each image protocol is necessity for request the best CBCT tomographic image

  2. Improvement In MAODV Protocol Using Location Based Routing Protocol

    Directory of Open Access Journals (Sweden)

    Kaur Sharnjeet

    2016-01-01

    Full Text Available Energy saving is difficult in wireless sensor network (WSN due to limited resources. Each node in WSN is constrained by their limited battery power for their energy. The energy is reduced as the time goes off due to the packet transmission and reception. Energy management techniques are necessary to minimize the total power consumption of all the nodes in the network in order to maximize its life span. Our proposed protocol Location based routing (LBR aimed to find a path which utilizes the minimum energy to transmit the packets between the source and the destination. The required energy for the transmission and reception of data is evaluated in MATLAB. LBR is implemented on Multicast Ad hoc On Demand Distance Vector Routing Protocol (MAODV to manage the energy consumption in the transmission and reception of data. Simulation results of LBR show the energy consumption has been reduced.

  3. Comparison of Clinical Efficacy of in vitro Fertilization-embryo Transfer Versus two Different Protocols after Super-long Down-regulation%IVF-ET中超长方案降调节后两种促排卵方案临床疗效比较

    Institute of Scientific and Technical Information of China (English)

    阳翎; 汤倩倩; 高士友

    2015-01-01

    【目的】探讨在体外受精‐胚胎移植(IVF‐ET )治疗中采用超常方案降调节后分别使用尿源性卵泡刺激素(u‐FSH)和基因重组FSH(r‐FSH)联合尿促性腺激素(HMG)促排后的临床结局。【方法】回顾性分析2013年1~12本院生殖中心559例接受IVF或卵胞浆单精子注射(ICSI)助孕治疗的临床结局。【结果】两组患者促性腺激素(gonadotropin ,Gn)天数、Gn使用剂量,获卵数、受精率、卵裂率、妊娠率、可利用胚胎数、种植率、流产率、异位妊娠率、卵巢过度刺激综合征(OHSS)发生率均无显著差异( P >0.05)。【结论】IVF‐ET中超长方案降调节后u‐FSH联合HMG和r‐FSH联合 HMG促排卵的效果相当。%[Objective] To compare the clinical efficacy of in vitro fertilization‐embryo transfer (IVF‐ET ) versus two different kinds of follicle‐stimulating hormone (FSH) stimulation protocols for controlled hyper‐stimulation after super‐long down‐regulation .[Methods]A total of 559 IVF/intracytoplasmic sperm injection (ICSI)‐ET cycles in in‐fertile patients at our reproductive center from January to November 2013 were analyzed retrospectively .According to the ovarian stimulation protocolr‐FSH+75IUHMG ,they were divided into two groups of gonal‐F ( n =294) and urofollitropin group ( n=265) .The clinical outcomes were compared between two groups .[Results]The total dos‐age of gonadotropin ,duration of gonadotropin stimulation ,estradiol level on HCG day ,number of retrieved oocytes , fertilization rate ,number of tranferable embryos ,clinical pregnancy rate ,implantation rate ,abortion rate ,rate of ec‐topic pregnancy and incidence of ovarian hyperstimulation syndrome were not significantly different between two groups ( P>0 .05) .[Conclusion]A combination of u‐FSH or r‐FSH and HMG have the same effectiveness in ovari‐an stimulation during IVF‐ET cycles after super‐long down‐regulation .

  4. Post surgey diet in the Columbus Bridge Protocol

    OpenAIRE

    P. Zunino; P. Pesce; P. Gavoglio; M. Menini; P. Pera

    2011-01-01

    Endosseous implants are really important in dentistry to correct maxillary edentulism, but in the international literature few information is provided regards the diet and the hygiene to be followed during the post-surgery in order to protect the osseointegration. The aim of this experimental work is to give a dietetic and hygienic protocol and to evaluate that with the patient's opinions and the operator's clinical evaluation.

  5. Post surgey diet in the Columbus Bridge Protocol

    Directory of Open Access Journals (Sweden)

    P. Zunino

    2011-01-01

    Full Text Available Endosseous implants are really important in dentistry to correct maxillary edentulism, but in the international literature few information is provided regards the diet and the hygiene to be followed during the post-surgery in order to protect the osseointegration. The aim of this experimental work is to give a dietetic and hygienic protocol and to evaluate that with the patient's opinions and the operator's clinical evaluation.

  6. Neonatal euthanasia: The Groningen Protocol*

    Science.gov (United States)

    Vizcarrondo, Felipe E.

    2014-01-01

    For the past thirty years, voluntary euthanasia and physician-assisted suicide of adult patients have been common practice in the Netherlands. Neonatal euthanasia was recently legalized in the Netherlands and the Groningen Protocol (GP) was developed to regulate the practice. Supporters claim compliance with the GP criteria makes neonatal euthanasia ethically permissible. An examination of the criteria used by the Protocol to justify the euthanasia of seriously ill neonates reveals the criteria are not based on firm moral principles. The taking of the life of a seriously ill person is not the solution to the pain and suffering of the dying process. It is the role of the medical professional to care for the ailing patient with love and compassion, always preserving the person's dignity. Neonatal euthanasia is not ethically permissible. PMID:25473136

  7. On using Mobile IP Protocols

    Directory of Open Access Journals (Sweden)

    Fayza A. Nada

    2006-01-01

    Full Text Available The recent advances in wireless communication technology and the unprecedented growth of the Internet have paved the way for wireless networking and IP mobility. Mobile Internet protocol has been designed within the IETF to support the mobility of users who wish to connect to the Internet and maintain communications as they move from place to place. This study describes and summarizes the current Internet draft for mobile IP (MIPv4 with its major components: agent discovery, registration and tunneling. In addition, we outline the available encapsulation techniques and route optimization procedure. In the end, we describe the design of the new protocol for transparent routing of IPv6 packets to mobile IPv6 nodes operating in the Internet.

  8. Neonatal euthanasia: The Groningen Protocol.

    Science.gov (United States)

    Vizcarrondo, Felipe E

    2014-11-01

    For the past thirty years, voluntary euthanasia and physician-assisted suicide of adult patients have been common practice in the Netherlands. Neonatal euthanasia was recently legalized in the Netherlands and the Groningen Protocol (GP) was developed to regulate the practice. Supporters claim compliance with the GP criteria makes neonatal euthanasia ethically permissible. An examination of the criteria used by the Protocol to justify the euthanasia of seriously ill neonates reveals the criteria are not based on firm moral principles. The taking of the life of a seriously ill person is not the solution to the pain and suffering of the dying process. It is the role of the medical professional to care for the ailing patient with love and compassion, always preserving the person's dignity. Neonatal euthanasia is not ethically permissible. PMID:25473136

  9. Chapter 14: Chiller Evaluation Protocol

    Energy Technology Data Exchange (ETDEWEB)

    Tiessen, A.

    2014-09-01

    This protocol defines a chiller measure as a project that directly impacts equipment within the boundary of a chiller plant. A chiller plant encompasses a chiller--or multiple chillers--and associated auxiliary equipment. This protocol primarily covers electric-driven chillers and chiller plants. It does not include thermal energy storage and absorption chillers fired by natural gas or steam, although a similar methodology may be applicable to these chilled water system components. Chillers provide mechanical cooling for commercial, institutional, multiunit residential, and industrial facilities. Cooling may be required for facility heating, ventilation, and air conditioning systems or for process cooling loads (e.g., data centers, manufacturing process cooling). The vapor compression cycle, or refrigeration cycle, cools water in the chilled water loop by absorbing heat and rejecting it to either a condensing water loop (water cooled chillers) or to the ambient air (air-cooled chillers).

  10. Kyoto: protocol on climate protection

    International Nuclear Information System (INIS)

    At the 3rd Conference of the Signatory States to the United Nations Climate Framework Convention held in Kyoto, the so-called Kyoto Protocol on the UN Climate Framework Convention was adopted unanimously, after two years of difficult and complex negotiations, on December 11, 1997. The protocol for the first time includes legally binding obligations for the industrialized countries requiring them to reduce their greenhouse gas emissions between 2008 and 2012 by a total of 5.2% relative to the 1990 level. In meeting this obligation, the industrialized countries assumed different levels of reduction and limitation, respectively. Thus, e.g., the EU countries accepted a Communitywide reduction by 8%, while the USA is obliged to reduce by 7% and Japan by 6%. (orig.)

  11. Superposition Attacks on Cryptographic Protocols

    DEFF Research Database (Denmark)

    Damgård, Ivan Bjerre; Funder, Jakob Løvstad; Nielsen, Jesper Buus;

    2011-01-01

    information. In this paper, we introduce a fundamentally new model of quantum attacks on classical cryptographic protocols, where the adversary is allowed to ask several classical queries in quantum superposition. This is a strictly stronger attack than the standard one, and we consider the security of...... string model. While our protocol is classical, it is sound against a cheating unbounded quantum prover and computational zero-knowledge even if the verifier is allowed a superposition attack. Finally, we consider multiparty computation and show that for the most general type of attack, simulation based...... several primitives in this model. We show that a secret-sharing scheme that is secure with threshold $t$ in the standard model is secure against superposition attacks if and only if the threshold is lowered to $t/2$. We use this result to give zero-knowledge proofs for all of NP in the common reference...

  12. DSTC Layering Protocols in Wireless Cooperative Networks

    CERN Document Server

    Elamvazhuthi, P S; Dey, B K

    2008-01-01

    In adhoc wireless relay networks, layers of relays are used to communicate from a source to a destination to achieve better reliability. In this paper, we consider five protocols derived from an earlier proposed protocol, where the relays do a simple processing before transmitting and as a result achieve distributed space-time code. Four of the protocols discussed utilize more complicated relaying schemes than simple layered protocols proposed in earlier literature. We have analyzed the effectiveness of these protocols in various power loss configurations among the paths. Optimum power allocation of the total power among various transmissions have been found by reasonable fine search for all the protocols. Bit error rate plots are compared under optimum power allocation for these protocols. From the simulation results, we draw some guidelines as to which protocol is good for what kind of environment.

  13. Automatic analysis of distance bounding protocols

    CERN Document Server

    Malladi, Sreekanth; Kothapalli, Kishore

    2010-01-01

    Distance bounding protocols are used by nodes in wireless networks to calculate upper bounds on their distances to other nodes. However, dishonest nodes in the network can turn the calculations both illegitimate and inaccurate when they participate in protocol executions. It is important to analyze protocols for the possibility of such violations. Past efforts to analyze distance bounding protocols have only been manual. However, automated approaches are important since they are quite likely to find flaws that manual approaches cannot, as witnessed in literature for analysis pertaining to key establishment protocols. In this paper, we use the constraint solver tool to automatically analyze distance bounding protocols. We first formulate a new trace property called Secure Distance Bounding (SDB) that protocol executions must satisfy. We then classify the scenarios in which these protocols can operate considering the (dis)honesty of nodes and location of the attacker in the network. Finally, we extend the const...

  14. A student teamwork induction protocol

    OpenAIRE

    Kamau, Caroline; Spong, A.

    2015-01-01

    Faulty group processes have harmful effects on performance but there is little research about intervention protocols to pre-empt them in HE. This naturalistic experiment compared a control cohort with an inducted cohort. The inducted cohort attended a workshop, consultations, elected a leader and used tools (a group log and group contract) designed to minimize social loafing, optimize coordination (by boosting good information sampling) and orient group dynamics towards the task. In the absen...

  15. Building America House Simulation Protocols

    Energy Technology Data Exchange (ETDEWEB)

    Hendron, Robert [National Renewable Energy Lab. (NREL), Golden, CO (United States); Engebrecht, Cheryn [National Renewable Energy Lab. (NREL), Golden, CO (United States)

    2010-09-01

    The House Simulation Protocol document was developed to track and manage progress toward Building America's multi-year, average whole-building energy reduction research goals for new construction and existing homes, using a consistent analytical reference point. This report summarizes the guidelines for developing and reporting these analytical results in a consistent and meaningful manner for all home energy uses using standard operating conditions.

  16. Heuristic Methods for Security Protocols

    OpenAIRE

    Qurat ul Ain Nizamani; Emilio Tuosto

    2009-01-01

    Model checking is an automatic verification technique to verify hardware and software systems. However it suffers from state-space explosion problem. In this paper we address this problem in the context of cryptographic protocols by proposing a security property-dependent heuristic. The heuristic weights the state space by exploiting the security formulae; the weights may then be used to explore the state space when searching for attacks.

  17. Analysing Protocol Stacks for Services

    DEFF Research Database (Denmark)

    Gao, Han; Nielson, Flemming; Nielson, Hanne Riis

    2011-01-01

    We show an approach, CaPiTo, to model service-oriented applications using process algebras such that, on the one hand, we can achieve a certain level of abstraction without being overwhelmed by the underlying implementation details and, on the other hand, we respect the concrete industrial standa...... financial case study taken from Chapter 0-3. Finally, we develop a static analysis to analyse the security properties as they emerge at the level of concrete industrial protocols....

  18. Feasible quantum communication complexity protocol

    International Nuclear Information System (INIS)

    I show that a simple multiparty communication task can be performed more efficiently with quantum communication than with classical communication, even with low detection efficiency η. The task is a communication complexity problem in which distant parties need to compute a function of the distributed inputs, while minimizing the amount of communication between them. A realistic quantum optical setup is suggested that can demonstrate a five-party quantum protocol with higher-than-classical performance, provided η>0.33

  19. Power Control Protocols in VANET

    OpenAIRE

    Samara, Ghassan; Salem, Amer O. Abu; Alhmiedat, Tareq

    2013-01-01

    Vehicular Ad hoc Networks (VANET) is one of the most challenging research area in the field of the Mobile Ad hoc Network (MANET), Power control is a critical issue in VANETwhere is should be managed carefully to help the channel to have high performance. In this paper a comparative study in the published protocols in the field of safety message dynamic power control will be presented and evaluated.

  20. Bounding Component Behavior via Protocols

    Czech Academy of Sciences Publication Activity Database

    Plášil, František; Višňovský, Stanislav; Besta, Miloslav

    Los Alamitos : IEEE Computer Society, 1999 - (Firesmith, D.; Riehle, R.; Pour, G.; Meyer, B.), s. 387-398 ISBN 0-7695-0278-4. [TOOLS /30./. Santa Barbara (US), 01.08.1999-05.08.1999] R&D Projects: GA AV ČR IAA2030902; GA ČR GA201/99/0244 Institutional research plan: AV0Z1030915 Keywords : software components * behavior protocols * software architecture Subject RIV: JC - Computer Hardware ; Software

  1. Security Protocol for Active Networks

    OpenAIRE

    Cheng, L.; Galis, A.

    2006-01-01

    Active packets carrying management and control code have a dynamic nature and support dynamic routing. Thus, active packets must be protected in an end-to-end and hop-to-hop fashion. In this paper, we present a novel approach, known as security protocol for active networks (SPAN), which enables an active packet to be securely transmitted during (instead of after) Security Association (SA) and management negotiations along a new execution path

  2. ACSEPP On-Line Electronic Payment Protocol

    Institute of Scientific and Technical Information of China (English)

    WANG Shao-bin; ZHU Xian; HONG Fan

    2004-01-01

    With analyzing the existing on-line electronic payment protocols, this paper presents a new on-line electronic payment protocol named ACSEPP: Anonymous, Convenient and Secure Electronic Payment Protocol.Its aim is to design a practical electronic payment protocol which is both secure and convenient.Without using PKI_CA frame, it realized the anonymity of consumer and merchant, the convenient of handling, the low cost of maintenance and the security.

  3. A father protocol for quantum broadcast channels

    CERN Document Server

    Dupuis, F; Dupuis, Fr\\'ed\\'eric; Hayden, Patrick

    2006-01-01

    We present a new protocol for quantum broadcast channels based on the fully quantum Slepian-Wolf protocol. The protocol yields an achievable rate region for entanglement-assisted transmission of quantum information through a quantum broadcast channel that can be considered the quantum analogue of Marton's region for classical broadcast channels. The protocol can be adapted to yield achievable rate regions for unassisted quantum communication and for entanglement-assisted classical communication. Regularized versions of all three rate regions are provably optimal.

  4. Component versioning for protocol configuration management

    Institute of Scientific and Technical Information of China (English)

    CHEN Tian-zhou; HE Zhen-jie; HUANG Jiang-wei; DAI Hong-jun

    2005-01-01

    Classical software configuration management which deals with source code versioning becomes insufficient when most components are distributed in binary form. As an important aspect of software configuration, protocol configuration also encounters those problems. This paper focuses on solving protocol component versioning issues for protocol configuration management on embedded system, incorporating the following versioning issues: version identification, version description and protocol component archiving and retrieving based on the version library.

  5. Crypto-Verifying Protocol Implementations in ML

    OpenAIRE

    Bhargavan, K.; Corin, R.J.; Fournet, C.

    2007-01-01

    We intend to narrow the gap between concrete implementations and verified models of cryptographic protocols. We consider protocols implemented in F#, a variant of ML, and verified using CryptoVerif, Blanchet's protocol verifier for computational cryptography. We experiment with compilers from F# code to CryptoVerif processes, and from CryptoVerif declarations to F# code. We present two case studies: an implementation of the Otway-Rees protocol, and an implementation of a simplified password-b...

  6. Simple and Efficient Contract Signing Protocol

    OpenAIRE

    Alaraj, Abdullah M.

    2012-01-01

    In this paper, a new contract signing protocol is proposed based on the RSA signature scheme. The protocol will allow two parties to sign the same contract and then exchange their digital signatures. The protocol ensures fairness in that it offers parties greater security: either both parties receive each other's signatures or neither does. The protocol is based on offline Trusted Third Party (TTP) that will be brought into play only if one party fails to sign the contract. Otherwise, the TTP...

  7. A father protocol for quantum broadcast channels

    OpenAIRE

    Dupuis, Frédéric; Hayden, Patrick; Li, Ke

    2006-01-01

    A new protocol for quantum broadcast channels based on the fully quantum Slepian-Wolf protocol is presented. The protocol yields an achievable rate region for entanglement-assisted transmission of quantum information through a quantum broadcast channel that can be considered the quantum analogue of Marton's region for classical broadcast channels. The protocol can be adapted to yield achievable rate regions for unassisted quantum communication and for entanglement-assisted classical communica...

  8. Static Validation of a Voting Protocol

    DEFF Research Database (Denmark)

    Nielsen, Christoffer Rosenkilde; Andersen, Esben Heltoft; Nielson, Hanne Riis

    The desired security properties of electronic voting protocols include verifiability, accuracy, democracy and fairness. In this paper we use a static program analysis tool to validate these properties for one of the classical voting protocols under appropriate assumptions. The protocol is...

  9. Cryptanalysis on Cheng et al. protocol

    Science.gov (United States)

    Thakur, Tejeshwari

    2016-06-01

    Deployment of new node in any wireless sensor network is a sensitive task. This is the reason why, an Access Control Protocol is required in WSN. In this paper, we demonstrate that Access Control Protocol proposed by Cheng et al.[1] for Wireless Sensor Network is insecure. The reason is that this protocol fails to resist the active attack.

  10. Reduction in gastrointestinal bleeding by development and implementation of a protocol for stress ulcer prophylaxis: a before-after study

    OpenAIRE

    Ikemura, Mai; Nakasako, Shinji; Seo, Ryutaro; Atsumi, Takahiro; Ariyoshi, Koichi; Hashida, Tohru

    2015-01-01

    Background The implementation of a protocol has been associated with improvements in the processes of care in clinical settings. Although stress ulcer prophylaxis is recommended for critically ill patients at high risk, there is currently no consensus on its use. Therefore, we herein developed a protocol for stress ulcer prophylaxis, and evaluated therapeutic outcomes in a before-after study. Methods The protocol was developed by considering the effectiveness, disadvantages (including adverse...

  11. Outcome analysis of individualized vestibular rehabilitation protocols

    Science.gov (United States)

    Black, F. O.; Angel, C. R.; Pesznecker, S. C.; Gianna, C.

    2000-01-01

    OBJECTIVE: To determine the outcome of vestibular rehabilitation protocols in subjects with peripheral vestibular disorders compared with normal and abnormal control subjects. STUDY DESIGN: Prospective study using repeated measure, matched control design. Subjects were solicited consecutively according to these criteria: vestibular disorder subjects who had abnormal results of computerized dynamic posturography (CDP) sensory organization tests (SOTs) 5 and 6 and underwent rehabilitation; vestibular disorder subjects who had abnormal results of SOTs 5 and 6 and did not undergo rehabilitation; and normal subjects (normal SOTs). SETTING: Tertiary neurotology clinic. SUBJECTS: Men and women over age 18 with chronic vestibular disorders and chief complaints of unsteadiness, imbalance, and/or motion intolerance, and normal subjects. INTERVENTIONS: Pre- and post-rehabilitation assessment included CDP, vestibular disability, and activities of daily living questionnaires. Individualized rehabilitation plans were designed and implemented to address the subject's specific complaints and functional deficits. Supervised sessions were held at weekly intervals, and self-administered programs were devised for daily home use. MAIN OUTCOME MEASURES: CDP composite and SOT scores, number of falls on CDP, and self-assessment questionnaire results. RESULTS: Subjects who underwent rehabilitation (Group A) showed statistically significant improvements in SOTs, overall composite score, and reduction in falls compared with abnormal (Group B) control groups. Group A's performances after rehabilitation were not significantly different from those of normal subjects (Group C) in SOTs 3 through 6, and close to normal on SOTs 1 and 2. Subjects in Group A also reported statistically significant symptomatic improvement. CONCLUSIONS: Outcome measures of vestibular protocol physical therapy confirmed objective and subjective improvement in subjects with chronic peripheral vestibular disorders. These

  12. Study on the safety and efficacy of miltefosine for the treatment of children and adolescents with post-kala-azar dermal leishmaniasis in Bangladesh, and an association of serum vitamin E and exposure to arsenic with post-kala-azar dermal leishmaniasis: an open clinical trial and case–control study protocol

    Science.gov (United States)

    Mondal, D; Hasnain, M G; Hossain, M S; Ghosh, D; Ghosh, P; Hossain, H; Baker, J; Nath, R; Haque, R; Matlashewski, G; Hamano, S

    2016-01-01

    Introduction Post-kala-azar dermal leishmaniasis (PKDL) is a dermatological complication that occurs primarily among treated visceral leishmaniasis (VL) patients, and sporadically in a few without a history of VL. It mostly affects children and adolescents but is also common in adults. The conventional treatment with 120 intramuscular injections of sodium stibogluconate (SSG) is phasing out. Miltefosine (MF) is the only eventual alternative to SSG; however, its efficacy and safety profiles for treatment of children and adolescents with PKDL are lacking. In addition, risk factors for PKDL are poorly investigated. Host genetic, nutritional and environmental factors could be potential risk factors. As such, here we propose to evaluate the efficacy and safety of MF for 12 weeks at an allometric dose for children and adolescents with PKDL, and also to explore potential risk factors for PKDL. Methods and analysis A cross-sectional survey will look for suspected participants with PKDL among treated VL children and adolescents, a subsequent open clinical trial with MF at allometric dose, with a follow-up at 12 months. A case–control study will be carried out for PKDL risk factors. Assuming 95% cure rate, 95% CI and α=0.05, a sample size of 73 children with PKDL is needed. Considering an attrition rate of 10%, the final sample size is 80 children in each group. Descriptive and analytical analyses will be performed. Primary outcome is safety and cure rate of 12 weeks of treatment with MF. Ethics and dissemination International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) Ethical Review Committee (ERC) approved the protocol (PR#013045). Written informed consent will be taken from all participants and their guardians (in case of minor). A Data and Safety Monitoring Board (DSMB) of ICDDR,B ERC will monitor all study activities to ensure the safety of the participants. Trial registration number NCT02193022; Pre-results. PMID:27188804

  13. Simple and Efficient Contract Signing Protocol

    CERN Document Server

    Alaraj, Abdullah M

    2012-01-01

    In this paper, a new contract signing protocol is proposed based on the RSA signature scheme. The protocol will allow two parties to sign the same contract and then exchange their digital signatures. The protocol ensures fairness in that it offers parties greater security: either both parties receive each other's signatures or neither does. The protocol is based on offline Trusted Third Party (TTP) that will be brought into play only if one party fails to sign the contract. Otherwise, the TTP remains inactive. The protocol consists of only three messages that are exchanged between the two parties.

  14. Sequence Patterns of Identity Authentication Protocols

    Institute of Scientific and Technical Information of China (English)

    Tao Hongcai; He Dake

    2006-01-01

    From the viewpoint of protocol sequence, analyses are made of the sequence patterns of possible identity authentication protocol under two cases: with or without the trusted third party (TTP). Ten feasible sequence patterns of authentication protocol with TTP and 5 sequence patterns without TTP are gained. These gained sequence patterns meet the requirements for identity authentication,and basically cover almost all the authentication protocols with TTP and without TTP at present. All of the sequence patterns gained are classified into unilateral or bilateral authentication. Then , according to the sequence symmetry, several good sequence patterns with TTP are evaluated. The accompolished results can provide a reference to design of new identity authentication protocols.

  15. Optimizing One Fair Document Exchange Protocol

    CERN Document Server

    Alaraj, Abdullah M

    2012-01-01

    This paper presents an efficient fair document exchange protocol. The exchange of the documents will be between two parties. The protocol is based on the verifiable and recoverable encryption of a document's key. This verifiable and recoverable encryption of the document's key will allow one party to verify the encrypted key. It will also ensure this party that the Semi Trusted Third Party will be able to recover the key if the other party misbehaves. The protocol also incorporates the concept of enforcing the honesty of one party. The proposed protocol consists of only three messages and is more efficient than related protocols.

  16. Vulnerabilities in Quantum Key Distribution Protocols

    CERN Document Server

    Kuhn, D R

    2003-01-01

    Recently proposed quantum key distribution protocols are shown to be vulnerable to a classic man-in-the-middle attack using entangled pairs created by Eve. It appears that the attack could be applied to any protocol that relies on manipulation and return of entangled qubits to create a shared key. The protocols that are cryptanalyzed in this paper were proven secure with respect to some eavesdropping approaches, and results reported here do not invalidate these proofs. Rather, they suggest that quantum cryptographic protocols, like conventional protocols, may be vulnerable to methods of attack that were not envisaged by their designers.

  17. Novel Ω-protocols for NP

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    Ω-protocols, introduced by Garay, Mackenzie and Yang, is a variant of S-protocols with online extractor which is a useful tool to overcome the nest effect in concurrent scenario. In this work, we construct an Ω-protocol for Hamiltonian cycle problem, and therefore, it allows us to present Ω-protocol for any NP relation. For most general NP relations, our construction of Ω-protocols is much more efficient than the informal one described by Garay et al. and we believe that the method for our construction may be of independent interest.

  18. Developing security protocols in χ-Spaces

    DEFF Research Database (Denmark)

    Crazzolara, Federico; Milicia, Giuseppe

    2002-01-01

    an implementation of SPL (Security Protocol Language), a formal model for studying security protocols. In this paper we discuss the use of χ-Spaces as a tool for developing robust security protocol implementations. To make the case, we take a family of key-translation protocols due to Woo and Lam and......It is of paramount importance that a security protocol effectively enforces the desired security requirements. The apparent simplicity of informal protocol descriptions hides the inherent complexity of their interactions which, often, invalidate informal correctness arguments and justify the effort...... of formal protocol verification. Verification, however, is usually carried out on an abstract model not at all related with a protocol’s implementation. Experience shows that security breaches introduced in implementations of successfully verified models are rather common. The χ-Spaces framework is...

  19. Desynchronization Attacks on RFID Security Protocols

    Directory of Open Access Journals (Sweden)

    Miaolei Deng

    2013-02-01

    Full Text Available The characteristics of radio frequency identification (RFID systems introduce growing security and privacy concerns. RFID systems need security protocols to provide confidentiality, user privacy, mutual authentication and etc. Many security protocols for the RFID system have been presented. This paper analyze several of the newest RFID security protocols which proposed by Niu et al., Fu et al. and Habibi et al. respectively form the security viewpoint of data desynchronization attack. These lightweight protocols were expected to proposed security protections for the RFID system and safeguard against almost all major attacks. However, we found that these RFID security protocols were vulnerable to the attack of data desynchronization. Based on strand spaces model, data desynchronization attacks on these protocols were analyzed and described. Furthermore, improvements to overcome the security vulnerabilities of two protocols presented by Niu et al. and Fu et al. were given.

  20. Effective Protocols for Mobile Communications and Networking

    Energy Technology Data Exchange (ETDEWEB)

    Espinoza, J.; Sholander, P.; Van Leeuwen, B,

    1998-12-01

    This report examines methods of mobile communications with an emphasis on mobile computing and wireless communications. Many of the advances in communications involve the use of Internet Protocol (IP), Asynchronous Transfer Mode (ATM), and ad hoc network protocols. However, many of the advances in these protocols have been focused on wired communications. Recently much focus has been directed at advancing communication technology in the area of mobile wireless networks. This report discusses various protocols used in mobile communications and proposes a number of extensions to existing protocols. A detailed discussion is also included on desirable protocol characteristics and evaluation criteria. In addition, the report includes a discussion on several network simulation tools that maybe used to evaluate network protocols.

  1. Language, Semantics, and Methods for Security Protocols

    DEFF Research Database (Denmark)

    Crazzolara, Federico

    Security protocols help in establishing secure channels between communicating systems. Great care needs therefore to be taken in developing and implementing robust protocols. The complexity of security-protocol interactions can hide, however, security weaknesses that only a formal analysis can...... reveal. The last few years have seen the emergence of successful intensional, event-based, formal approaches to reasoning about security protocols. The methods are concerned with reasoning about the events that a security protocol can perform, and make use of a causal dependency that exists between...... representation and do not address how to build up protocol representations in a compositional fashion. This dissertation presents a new, event-based approach to reasoning about security protocols. We seek a broader class of models to show how event-based models can be structured in a compositional way and so...

  2. Authenticating Tripartite Key Agreement Protocol with Pairings

    Institute of Scientific and Technical Information of China (English)

    Sheng-Li Liu; Fang-Guo Zhang; Ke-Fei Chen

    2004-01-01

    In this paper, an authenticated tripartite key agreement protocol is proposed, which is an ID-based one with pairings. This protocol involves only one round. The authenticity of the protocol is assured by a special signature scheme, so that messages carrying the information of two ephemeral keys can be broadcasted authentically by an entity. Consequently, one instance of the protocol results in eight session keys for three entities. In other word, one instance of the protocol generates a session key, which is eight times longer than those obtained from traditional key agreement protocols. Security attributes of the protocol are presented, and the computational overhead and bandwidth of the broadcast messages are analyzed as well.

  3. Generalized routing protocols for multihop relay networks

    KAUST Repository

    Khan, Fahd Ahmed

    2011-07-01

    Performance of multihop cooperative networks depends on the routing protocols employed. In this paper we propose the last-n-hop selection protocol, the dual path protocol, the forward-backward last-n-hop selection protocol and the forward-backward dual path protocol for the routing of data through multihop relay networks. The average symbol error probability performance of the schemes is analysed by simulations. It is shown that close to optimal performance can be achieved by using the last-n-hop selection protocol and its forward-backward variant. Furthermore we also compute the complexity of the protocols in terms of number of channel state information required and the number of comparisons required for routing the signal through the network. © 2011 IEEE.

  4. A protocol for quantitative PET in cerebral ischaemia

    International Nuclear Information System (INIS)

    Full text: The Austin Hospital Centre for PET is involved in research protocols utilising 15O-labelled gases and 15O-labelled water to study regional cerebral blood flow, and oxygen metabolism. The Stroke Unit in particular refers patients for both PET and SPECT imaging as part of clinical research protocols into the time evolution of cerebral tissue viability following ischaemic insult, and the effect of intervention with anticoagulant therapy on patient outcome. These studies, involving the co-ordination of isotope production and quality control, administration of radioactive gases and water, arterial blood sampling and complex image processing, whilst maintaining patient care of often acutely ill patients, present a challenging task for the nuclear medicine technologist. We describe our protocol which consists of an 15O-carbon dioxide perfusion study, transmission scan, 15O-oxygen metabolism study, and 15O water perfusion study with automated arterial blood sampling performed during all three acquisitions. Selected patients also undergo 99mTc-HMPAO SPECT immediately following the PET study. The automated arterial blood sampler, 15O-water generator and 15O-gas delivery system (GDS) are unique to PET and their operation and application to patient studies will be described. To date, 85 patient studies have been performed using this protocol and we find it relatively easy to apply in the clinical setting and reasonably well tolerated by patients. In the future it is hoped to dispense with the need for arterial blood sampling thus making these studies a suitable proposition for the clinical evaluation of even very acute stroke patients

  5. Planetary Protection Alternate Protocol Certification

    Science.gov (United States)

    Baker, Amy; Barengoltz, Jack; Tisdale, David

    The talk presents a standardized approach for new method certification or alterative testing protocol (ATP) certification against the existing U.S. Planetary Protection Standards. In consideration of new method certification there are two phases of activities that are relevant to the certification process. The first is sample acquisition which typically incorporates swab or wipes sampling on relevant hardware, associated facilities and ground support equipment. The sampling methods introduce considerations of field sampling efficiency as it relates to spore distribution on the spacecraft, spacecraft material influences on the ability of the swab or wipe to remove spores from the hardware, the types of swabs and wipes used (polyester, cotton, macrofoam), and human sampling influences. The second portion of a new protocol certification looks specifically at the lab work-up or analysis of the samples provided to the laboratory. Variables in this process include selection of appropriate biomarkers, extraction efficiencies (removal of spores or constituents of interest from the sampling device), and a method's ability to accurately determine the number of spores present in the sample with a statistically valid level of confidence as described by parameters such as precision, accuracy, robustness, specificity and sensitivity. Considerations for alternative testing protocols such as those which utilize bioburden reduction techniques include selection of appropriate biomarkers for testing, test materials and a defined statistical approach that provides sufficient scientific data to support the modification of an existing NASA specification or the generation of a new NASA specification. Synergies between the U.S. and European Space Agency approaches will also be discussed.

  6. Clinical aspects of boron neutron capture therapy

    International Nuclear Information System (INIS)

    Boron neutron capture therapy is potentially useful in treating malignant tumors of the central nervous system and is technically possible. Additional in vitro and in vivo testing is required to determine toxicities, normal tissue tolerances and tissue responses to treatment parameters. Adequate tumor uptake of the capture agent can be evaluated clinically prior to implementation of a finalized treatment protocol. Phase I and Phase II protocol development, clinical pharmacokinetic studies and neutron beam development

  7. Protocols for calibrating multibeam sonar

    OpenAIRE

    Foote, Kenneth G.; Chu, Dezhang; Hammar, Terence R.; Baldwin, Kenneth C.; Mayer, Larry A.; Hufnagle, Lawrence C. jr.; Jech, J. Michael

    2005-01-01

    Development of protocols for calibrating multibeam sonar by means of the standard-target method is documented. Particular systems used in the development work included three that provide the water-column signals, namely the SIMRAD SM2000/90- and 200-kHz sonars and RESON SeaBat 8101 sonar, with operating frequency of 240 kHz. Two facilities were instrumented specifically for the work: a sea well at the Woods Hole Oceanographic Institution and a large, indoor freshwater tank at the University o...

  8. Optical protocols for terabit networks

    Science.gov (United States)

    Chua, P. L.; Lambert, J. L.; Morookian, J. M.; Bergman, L. A.

    1991-01-01

    This paper describes a new fiber-optic local area network technology providing 100X improvement over current technology, has full crossbar funtionality, and inherent data security. Based on optical code-division multiple access (CDMA), using spectral phase encoding/decoding of optical pulses, networking protocols are implemented entirely in the optical domain and thus conventional networking bottlenecks are avoided. Component and system issues for a proof-of-concept demonstration are discussed, as well as issues for a more practical and commercially exploitable system. Possible terrestrial and aerospace applications of this technology, and its impact on other technologies are explored. Some initial results toward realization of this concept are also included.

  9. Research on Container Behaviors Protocol

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    With the development of middleware technology, there are some new features to be adopted on demand in middleware platform based on container component. Aiming at the adaptation of middleware platform, from the nature of component container, this paper begins with behaviors features of EJB (Enterprise Java Bean) container, extracts general behaviors protocol of container, and defines its formal behaviors specification. In the end, the interactive relationship of components is described by WRIGHT language, and the configuration of whole system is shown. The method proposed in this paper mines the hidden features of framework of component container, and applies to refactor middleware platform in reflection and aspect-oriented programming technology.

  10. Secure E-Commerce Protocol

    Directory of Open Access Journals (Sweden)

    Khalid Haseeb, Muhammad Arshad, Shoukat Ali, Shazia Yasin

    2011-04-01

    Full Text Available E-commerce has presented a new way of doing business all over the world using internet.Organizations have changed their way of doing business from a traditional approach to embrace ecommerceprocesses. As individuals and businesses increase information sharing, a concernregarding the exchange of money securely and conveniently over the internet increases. Therefore,security is a necessity in an e-commerce transaction. The purpose of this paper is to present atoken based Secure E-commerce Protocol. The purpose of this paper is to present a paradigm thatis capable of satisfying security objectives by using token based security mechanism.

  11. Trust relationships in exchange protocols

    OpenAIRE

    González-Deleito Collell, Nicolás

    2005-01-01

    Les protocoles d'échange d'informations représentent un des grands domaines actuels de recherche en sécurité informatique, et sont entre autres à la base des mécanismes de commerce électronique. Ils sont par exemple nécessaires à la réalisation d'un achat en ligne, à la signature d'un contrat électronique et au courrier électronique recommandé. Dans ces exemples, les échanges d'informations consistent à échanger respectivement un objet électronique contre un paiement, des signatures digitales...

  12. Trypanosoma spp. ring test protocol

    International Nuclear Information System (INIS)

    Test material will be chosen by the coordinating lab for incorporation into a proficiency panel after repeated testing by more than one analyst on multiple PCR runs on different days. Test material: suitable test material will be provided. Protocol and laboratory procedures: Each laboratory is allowed to use their own 'in-house' test procedure (SOPs will nevertheless be provided by the respective laboratories for comparison and evaluation). Each PCR should be executed on two separate occasions. Test material used will be coded and sent as a blind panel to the participants. Each participating laboratory will be given a unique set of codes

  13. New Models for Population Protocols

    CERN Document Server

    Michail, Othon

    2010-01-01

    Wireless sensor networks are about to be part of everyday life. Homes and workplaces capable of self-controlling and adapting air-conditioning for different temperature and humidity levels, sleepless forests ready to detect and react in case of a fire, vehicles able to avoid sudden obstacles or possibly able to self-organize routes to avoid congestion, and so on, will probably be commonplace in the very near future. Mobility plays a central role in such systems and so does passive mobility, that is, mobility of the network stemming from the environment itself. The population protocol model was

  14. Internet protocol television (IPTV) services

    OpenAIRE

    Nuuri, Aminullah

    2011-01-01

    The purpose of this thesis is to know what IPTV is and how the IPTV network architectures work. The role of IPTV is to deliver video, audio and data commonly called triple play services over an IP network. This thesis describes how video on demand (VOD) shows its relation to the IPTV and introduces unicast and multicast services, IPTV protocols such as RTP and RSTP, IPTV set-top box and some other common ways of this particular technology. It also demonstrates how the Sonera IPTV system deliv...

  15. Analyzing the effect of routing protocols on media access control protocols in radio networks

    Energy Technology Data Exchange (ETDEWEB)

    Barrett, C. L. (Christopher L.); Drozda, M. (Martin); Marathe, A. (Achla); Marathe, M. V. (Madhav V.)

    2002-01-01

    We study the effect of routing protocols on the performance of media access control (MAC) protocols in wireless radio networks. Three well known MAC protocols: 802.11, CSMA, and MACA are considered. Similarly three recently proposed routing protocols: AODV, DSR and LAR scheme 1 are considered. The experimental analysis was carried out using GloMoSim: a tool for simulating wireless networks. The main focus of our experiments was to study how the routing protocols affect the performance of the MAC protocols when the underlying network and traffic parameters are varied. The performance of the protocols was measured w.r.t. five important parameters: (i) number of received packets, (ii) average latency of each packet, (iii) throughput (iv) long term fairness and (v) number of control packets at the MAC layer level. Our results show that combinations of routing and MAC protocols yield varying performance under varying network topology and traffic situations. The result has an important implication; no combination of routing protocol and MAC protocol is the best over all situations. Also, the performance analysis of protocols at a given level in the protocol stack needs to be studied not locally in isolation but as a part of the complete protocol stack. A novel aspect of our work is the use of statistical technique, ANOVA (Analysis of Variance) to characterize the effect of routing protocols on MAC protocols. This technique is of independent interest and can be utilized in several other simulation and empirical studies.

  16. Staged Protocol in Treatment of Open Distal Tibia Fracture: Using Lateral MIPO

    OpenAIRE

    Sohn, Oog Jin; Kang, Dong Hwa

    2011-01-01

    Background To evaluate the radiological, clinical results in patients with open distal tibia factures, who were treated with a staged treatment protocol using the lateral minimally invasive plate osteosynthesis (MIPO) technique. Methods From January 2007 to June 2009, 10 patients with open distal tibia fractures (Gustilo-Anderson classification II, 3; IIIA, 1; IIIB, 6) were treated using a staged treatment protocol. The initial debridement and application of an external fixator were performed...

  17. Breakthrough reactions of iodinated and gadolinium contrast media after oral steroid premedication protocol

    OpenAIRE

    Jingu, Akiko; Fukuda, Junya; Taketomi-Takahashi, Ayako; Tsushima, Yoshito

    2014-01-01

    Background Adverse reactions to iodinated and gadolinium contrast media are an important clinical issue. Although some guidelines have proposed oral steroid premedication protocols to prevent adverse reactions, some patients may have reactions to contrast media in spite of premedication (breakthrough reaction; BTR). The purpose of this study was to assess the frequency, type and severity of BTR when following an oral steroid premedication protocol. Methods All iodinated and gadolinium contras...

  18. Latest approaches of Kyoto protocol

    International Nuclear Information System (INIS)

    Recently EURELECTRIC welcome the proposal of new EC Directive concerning the inclusion in the EU Emissions Trading Scheme (ETS) of credits from the project mechanisms - Joint Implementation (JI) and Clean Development Mechanism (CDM). The proposed Directive is an amendment to the EU Emissions Trading Directive adopted in June 2003. EURELECTRIC calls for unlimited use of credits in ETS. The draft Directive provides for the application of these mechanisms to begin as of 2008, on condition that the Kyoto Protocol does actually enter into force, an event which is still dependent on Russia's ratification. Such ratification has been subject to contradictory statements from the Russian Government, and the question of whether their signature to the Protocol is forthcoming is still fraught with uncertainty. Although it is not anticipated that significant quantities of JI or CDM certified credits will be available in the period 2005-2007, those that do become available would provide some additional liquidity in the emissions trading market. There is a direct relation between the coming ETS and electricity pricing: environmental policy is the driver, based on the need to switch to a low-carbon future and manage the necessary investments in a rational manner - and emissions trading is the best solution available. Romania has good opportunities to be involved in the greenhouse gases market, both in ETS and JI mechanisms. Some JI projects between Romanian and The Netherlands are already done or underway. (author)

  19. Development of low-dose protocols for thin-section CT assessment of cystic fibrosis in pediatric patients.

    LENUS (Irish Health Repository)

    O'Connor, Owen J

    2010-12-01

    To develop low-dose thin-section computed tomographic (CT) protocols for assessment of cystic fibrosis (CF) in pediatric patients and determine the clinical usefulness thereof compared with chest radiography.

  20. Guest Editorial: Gait coordination protocol for recovery of coordinated gait, function, and quality of life following stroke

    OpenAIRE

    Janis J. Daly, PhD, MS; Jessica P. McCabe, MPT; Jennifer Gansen, DPT; Jean Rogers, PT; Kristi Butler, MPT; Irene Brenner, MSPT; Richard Burdsall, PT; Joan Nethery, MA, PT, NCS

    2012-01-01

    The Gait Coordination Protocol (GCP) was successful in producing clinically and statistically significant gains in impairment, function, and life-role participation for those in the chronic phase after stroke who had exhibited persistent moderate to severe gait deficits.

  1. 术前综合评价对输尿管结石梗阻急性肾衰竭患者治疗方案选择的临床价值%Clinical value of pre-operative general evaluation on therapeutic protocol selection in patients with acute renal failure induced by ureteral calculus obstruction

    Institute of Scientific and Technical Information of China (English)

    黄家财; 杨文彬

    2012-01-01

    Objective To understand the clinical value of pre-operative general evaluation on therapeutic protocol selection in pa-tients with acute renal failure induced by ureteral calculus obstruction. Methods 86 patients defined as acute renal failure induced by ureteral calculus obstruction were assigned into safe group(11 -15 points),risk group(7 -10 points) and dangerous group(< 7points) according to the biochemistry indexes, conditions of ureteral obstruction and hydronephrosis. Patients in safe group and dangerous group respectively underwent urgent surgery and post-hemodialysis surgery. Patients in risk group underwent either urgent surgery or post-hemodialysis surgery, according to patients' situation. Following up for 1 month after surgery, to evaluate the situation of renal function recovery,ureteral obstruction and hydronephrosis in patients. Results In safe group, renal function were completely recovery, while reteral obstruction and hydronephrosis were completely relieved. In risk group,renal function were completely recovery, while there were one patient with ureteral obstruction and one patient with hydronephrosis. There were four patients with mild renal impairment in dangerous group. Two patients of them were with ureteral obstruction, and the other two of them were with hydronephrosis. Conclusion Pre-operative general evaluation was of great value on the selection of therapeutic protocol in patients with acute renal failure inducded by ureteral calculus obstruction.%目的 探讨术前综合评价对输尿管结石梗阻急性肾衰竭患者治疗方案选择的临床价值.方法 收集确诊为输尿管结石梗阻急性肾衰竭患者86例,依据患者生化指标、输尿管梗阻和肾积水梗阻情况,分为安全组(11~15分),风险组(7~10分)和危险组(<7分).安全组患者予立即行手术治疗;风险组患者根据患者情况予血液透析后行手术治疗或予急诊手术治疗;危险组患者予血液透析后

  2. Efeito do ultra-som terapêutico em tendinite experimental de eqüinos: estudo clínico, ultra-sonográfico e histopatológico de dois protocolos Clinic, ultrasonographic and histopatological studies of two protocols of ultrasonic therapy on experimental tendonitis in horses

    Directory of Open Access Journals (Sweden)

    M.A.L. Fernandes

    2003-02-01

    Full Text Available Avaliaram-se dois protocolos de ultra-som no tratamento de lesões do tendão flexor digital superficial (TFDS. Foram estudados 18 eqüinos, nos quais foi injetada uma solução de colagenase a 0,25% no TFDS esquerdo, à altura do terço médio da região metacarpiana. Os eqüinos foram divididos em: grupo A - tratado por ultra-som (UST na freqüência de 3 MHz e intensidade de 1W/cm², no modo contínuo, por seis minutos; grupo B - tratado na mesma freqüência, intensidade e tempo, no modo pulsado; e grupo C - controle. Os tratamentos foram iniciados 48h após a indução da lesão, totalizando oito sessões. Os eqüinos foram estudados por 40 dias, avaliando-se o quadro clínico e a regressão dos sintomas. Por meio de exames ultra-sonográficos semanais avaliaram-se a área transversal e a ecogenicidade da lesão para estabelecimento do índice de severidade (IS. A lesão resultou em aumento médio de 1,5cm na circunferência da região metacarpiana, resposta à pressão digital de leve a moderada e grau de claudicação de 1 a 3. A regressão dos sintomas ocorreu, em média, nove dias no grupo A, 12 dias no grupo B e 21 dias no grupo C. O percentual de regressão no IS aos 40 dias foi de 42,5, 57,7 e 34,1, respectivamente. A avaliação histológica mostrou neovascularização pronunciada e maior atividade fibroblástica nos grupos tratados (A e B comparados ao grupo-controle. Estes resultados sugerem que o UST é efetivo na redução dos sintomas clínicos da tendinite.In order to evaluate two therapeutic ultrasound protocols for treatment of injuries of the superficial digital flexor tendon (SDFT a study was performed in 18 horses. In each horse, a 0.25% solution of collagenase was injected in the middle of the left SDFT. The horses were randomly and equally divided into three groups. Horses from Group A were treated with therapeutic ultrasound of 3 MHz frequency and 1 W/cm² intensity on continuous mode for six minutes; horses from Group

  3. How blockchain-timestamped protocols could improve the trustworthiness of medical science [version 2; referees: 2 approved

    OpenAIRE

    Greg Irving; John Holden

    2016-01-01

    Trust in scientific research is diminished by evidence that data are being manipulated. Outcome switching, data dredging and selective publication are some of the problems that undermine the integrity of published research. Methods for using blockchain to provide proof of pre-specified endpoints in clinical trial protocols were first reported by Carlisle. We wished to empirically test such an approach using a clinical trial protocol where outcome switching has previously been reported. Here w...

  4. Telomerase Repeated Amplification Protocol (TRAP)

    Science.gov (United States)

    Mender, Ilgen; Shay, Jerry W.

    2016-01-01

    Telomeres are found at the end of eukaryotic linear chromosomes, and proteins that bind to telomeres protect DNA from being recognized as double-strand breaks thus preventing end-to-end fusions (Griffith et al., 1999). However, due to the end replication problem and other factors such as oxidative damage, the limited life span of cultured cells (Hayflick limit) results in progressive shortening of these protective structures (Hayflick and Moorhead, 1961; Olovnikov, 1973). The ribonucleoprotein enzyme complex telomerase-consisting of a protein catalytic component hTERT and a functional RNA component hTR or hTERC- counteracts telomere shortening by adding telomeric repeats to the end of chromosomes in ~90% of primary human tumors and in some transiently proliferating stem-like cells (Shay and Wright, 1996; Shay and Wright, 2001). This results in continuous proliferation of cells which is a hallmark of cancer. Therefore, telomere biology has a central role in aging, cancer progression/metastasis as well as targeted cancer therapies. There are commonly used methods in telomere biology such as Telomere Restriction Fragment (TRF) (Mender and Shay, 2015b), Telomere Repeat Amplification Protocol (TRAP) and Telomere dysfunction Induced Foci (TIF) analysis (Mender and Shay, 2015a). In this detailed protocol we describe Telomere Repeat Amplification Protocol (TRAP). The TRAP assay is a popular method to determine telomerase activity in mammalian cells and tissue samples (Kim et al., 1994). The TRAP assay includes three steps: extension, amplification, and detection of telomerase products. In the extension step, telomeric repeats are added to the telomerase substrate (which is actually a non telomeric oligonucleotide, TS) by telomerase. In the amplification step, the extension products are amplified by the polymerase chain reaction (PCR) using specific primers (TS upstream primer and ACX downstream primer) and in the detection step, the presence or absence of telomerase is

  5. The comparative cost analysis of EAP Re-authentication Protocol and EAP TLS Protocol

    Directory of Open Access Journals (Sweden)

    Seema Mehla

    2010-05-01

    Full Text Available the Extensible Authentication Protocol (EAP is a generic framework supporting multiple types of authentication methods. In systems where EAP is used for authentication, it is desirable to not repeat the entire EAP exchange with another authenticator. The EAP reauthentication Protocol provides a consistent, methodindependentand low-latency re-authentication. It is extension to current EAP mechanism to support intradomain handoff authentication. This paper analyzed the performance of the EAP re-authentication protocol, andcompared it with that of the EAP-TLS protocol. The result shows that the authentication delay of EAP reauthentication protocol is only twentieth of that in the EAPTLS protocol.

  6. Novel construction of Secure RFID Authentication Protocol

    Directory of Open Access Journals (Sweden)

    Shafiqul Abidin

    2014-10-01

    Full Text Available This article proposes an efficient and secure authentication protocol for secure and low-cost RFID systems in random oracles. Security is one of the prime concerns of RFID system. Proposed protocol relies on Elliptic Curve Discrete Logarithm Problem (ECDLP to achieve security. The protocol achieves the most important security goals scalability, anonymity and anti-cloning for RFID system. A password based protocol has vulnerability on fixed password. This can be exploited by threats. In the proposed protocol, there is a provision to change the password of the Tags. Hence the vulnerability can be reduced in an acceptable level. Computation cost is very less as compare to the other protocols.

  7. The Simplest Protocol for Oblivious Transfer

    DEFF Research Database (Denmark)

    Chou, Tung; Orlandi, Claudio

    2015-01-01

    Oblivious Transfer (OT) is the fundamental building block of cryptographic protocols. In this paper we describe the simplest and most efficient protocol for 1-out-of-n OT to date, which is obtained by tweaking the Diffie-Hellman key-exchange protocol. The protocol achieves UC-security against...... optimizations) is at least one order of magnitude faster than previous work. Category / Keywords: cryptographic protocols / Oblivious Transfer, UC Security, Elliptic Curves, Efficient Implementation...... active and adaptive corruptions in the random oracle model. Due to its simplicity, the protocol is extremely efficient and it allows to perform m 1-out-of-n OTs using only: - Computation: (n+1)m+2 exponentiations (mn for the receiver, mn+2 for the sender) and - Communication: 32(m+1) bytes (for the group...

  8. Symmetric cryptographic protocols for extended millionaires' problem

    Institute of Scientific and Technical Information of China (English)

    LI ShunDong; WANG DaoShun; DAI YiQi

    2009-01-01

    Yao's millionaires' problem is a fundamental problem in secure multiparty computation, and its solutions have become building blocks of many secure multiparty computation solutions. Unfortunately,most protocols for millionaires' problem are constructed based on public cryptography, and thus are inefficient. Furthermore, all protocols are designed to solve the basic millionaires' problem, that is,to privately determine which of two natural numbers is greater. If the numbers are real, existing solutions do not directly work. These features limit the extensive application of the existing protocols. This study introduces and refines the first symmetric cryptographic protocol for the basic millionaires' problem, and then extends the symmetric cryptographic protocol to privately determining which of two real numbers is greater, which are called the extended millionaires' problem, and proposes corresponding Constructed based on symmetric cryptography, these protocols are very efficient.

  9. VANET Routing Protocols: Pros and Cons

    CERN Document Server

    Paul, Bijan; Bikas, Md Abu Naser

    2012-01-01

    VANET (Vehicular Ad-hoc Network) is a new technology which has taken enormous attention in the recent years. Due to rapid topology changing and frequent disconnection makes it difficult to design an efficient routing protocol for routing data among vehicles, called V2V or vehicle to vehicle communication and vehicle to road side infrastructure, called V2I. The existing routing protocols for VANET are not efficient to meet every traffic scenarios. Thus design of an efficient routing protocol has taken significant attention. So, it is very necessary to identify the pros and cons of routing protocols which can be used for further improvement or development of any new routing protocol. This paper presents the pros and cons of VANET routing protocols for inter vehicle communication.

  10. Summary Report on Unconditionally Secure Protocols

    DEFF Research Database (Denmark)

    Damgård, Ivan Bjerre; Salvail, Louis; Cachin, Christian

    This document describes the state of the art snd some of the main open problems in the area of unconditionally secure cryptographic protocols. The most essential part of a cryptographic protocol is not its being secure. Imagine a cryptographic protocol which is secure, but where we do not know...... that it is secure. Such a protocol would do little in providing security. When all comes to all, cryptographic security is done for the sake of people, and the essential part of security is for people what it has always been, namely to feel secure. To feel secure employing a given cryptographic protocol we need...... to know that is is secure. I.e. we need a proof that it is secure. Today the proof of security of essentially all practically employed cryptographic protocols relies on computational assumptions. To prove that currently employed ways to communicate securely over the Internet are secure we e.g. need...

  11. Comparación de resultados previos y posteriores a la aplicación de un protocolo de actuación en cirugía bariátrica Effect of a multidisciplinar protocol on the clinical results obtained after bariatric surgery

    Directory of Open Access Journals (Sweden)

    B. Cánovas Gaillemin

    2011-02-01

    Full Text Available Introducción: La cirugía bariátrica ha demostrado ser un tratamiento eficaz para la pérdida de peso en pacientes con obesidad severa, recomendándose la aplicación de un protocolo de actuación multidisciplinar. Objetivos: Evaluar la utilidad de la implantación de un protocolo de actuación en cirugía de la obesidad basado en el Documento de consenso español de la SEEDO. Métodos: Estudio restrospectivo comparativo de resultados de pacientes intervenidos previamente (51 pacientes y tras la implantación del protocolo (66 pacientes. Se recogieron datos de: antropometría , comorbilidades pre y postcirugía, complicaciones nutricionales y quirúrgicas postcirugía, test de Calidad de Vida validado, y hábitos alimentarios. Resultados: Los abandonos (17,6% y el alcoholismo (5,8% fueron mayores en pacientes preprotocolo frente postprotocolo (4,5% y 3% respectivamente con diferencias estadísticamente significativas. La mortalidad fue del 2% en los preprotocolo y del 0% en los postprotocolo. Los hábitos alimentarios fueron mejores en los postprotocolo, presentando mayor porcentaje de trastornos de conducta alimentaria los preprotocolo (5,1% aunque sin significación estadística. La mejoría de la calidad de vida fue superior en los postprotocolo en todos los items, pero solo con significación estadística en la actividad sexual (p 0,004. El 70,5% de los pacientes preprotocolo tenían más de una complicación nutricional frente al 32,8% de los postprotocolo (p Introduction: Bariatric surgery has been shown to be an effective therapy for weight loss in patients with severe obesity, and the implementation of a multidisciplinar management protocol is recommended. Objectives: To assess the usefulness of the implementation of a management protocol in obesity surgery based on the Spanish Consensus Document of the SEEDO. Methods: Retrospective comparative study of the outcomes in patients previously operated (51 patients and after the

  12. Massive transfusion protocols: current best practice

    Directory of Open Access Journals (Sweden)

    Hsu YM

    2016-03-01

    Full Text Available Yen-Michael S Hsu,1 Thorsten Haas,2 Melissa M Cushing1 1Department of Pathology and Laboratory Medicine, Weill Cornell Medical College, New York, NY, USA; 2Department of Anesthesia, University Children's Hospital Zurich, Zurich, Switzerland Abstract: Massive transfusion protocols (MTPs are established to provide rapid blood replacement in a setting of severe hemorrhage. Early optimal blood transfusion is essential to sustain organ perfusion and oxygenation. There are many variables to consider when establishing an MTP, and studies have prospectively evaluated different scenarios and patient populations to establish the best practices to attain improved patient outcomes. The establishment and utilization of an optimal MTP is challenging given the ever-changing patient status during resuscitation efforts. Much of the MTP literature comes from the trauma population, due to the fact that massive hemorrhage is the leading cause of preventable trauma-related death. As we come to further understand the positive and negative clinical impacts of transfusion-related factors, massive transfusion practice can be further refined. This article will first discuss specific MTPs targeting different patient populations and current relevant international guidelines. Then, we will examine a wide selection of therapeutic products to support MTPs, including newly available products and the most suitable of the traditional products. Lastly, we will discuss the best design for an MTP, including ratio-based MTPs and MTPs based on the use of point-of-care coagulation diagnostic tools. Keywords: hemorrhage, MTP, antifibrinolytics, coagulopathy, trauma, ratio, logistics, guidelines, hemostatic

  13. Training parents to implement pediatric feeding protocols.

    OpenAIRE

    Mueller, Michael M; Piazza, Cathleen C; Moore, James W; Kelley, Michael E; Bethke, Stephanie A; Pruett, Angela E; Oberdorff, Amanda J; Layer, Stacy A

    2003-01-01

    Four different multicomponent training packages were evaluated to increase the treatment integrity of parents implementing pediatric feeding protocols. In Study 1 we exposed 3 parents to a training package that consisted of written protocols (baseline), verbal instructions, therapist modeling, and rehearsal training. Results suggested that the package was successful in increasing treatment integrity of the feeding protocols to high levels. Study 2 investigated three different parent-training ...

  14. Formal Support for Standardizing Protocols with State

    OpenAIRE

    Guttman, Joshua D.; Liskov, Moses D.; Ramsdell, John D.; Rowe, Paul D.

    2015-01-01

    Many cryptographic protocols are designed to achieve their goals using only messages passed over an open network. Numerous tools, based on well-understood foundations, exist for the design and analysis of protocols that rely purely on message passing. However, these tools encounter difficulties when faced with protocols that rely on non-local, mutable state to coordinate several local sessions. We adapt one of these tools, {\\cpsa}, to provide automated support for reasoning about state. We us...

  15. Bitcoin-NG: A Scalable Blockchain Protocol

    OpenAIRE

    Eyal, Ittay; Gencer, Adem Efe; Sirer, Emin Gun; van Renesse, Robbert

    2015-01-01

    Cryptocurrencies, based on and led by Bitcoin, have shown promise as infrastructure for pseudonymous online payments, cheap remittance, trustless digital asset exchange, and smart contracts. However, Bitcoin-derived blockchain protocols have inherent scalability limits that trade-off between throughput and latency and withhold the realization of this potential. This paper presents Bitcoin-NG, a new blockchain protocol designed to scale. Based on Bitcoin's blockchain protocol, Bitcoin-NG is By...

  16. Faked states attack and quantum cryptography protocols

    CERN Document Server

    Denny, Travis

    2011-01-01

    Leveraging quantum mechanics, cryptographers have devised provably secure key sharing protocols. Despite proving the security in theory, real-world application falls short of the ideal. Last year, cryptanalysts completed an experiment demonstrating a successful eavesdropping attack on commercial quantum key distribution (QKD) systems. This attack exploits a weakness in the typical real-world implementation of quantum cryptosystems. Cryptanalysts have successfully attacked several protocols. In this paper, we examine the Kak quantum cryptography protocol and how it may perform under such attacks.

  17. Security in network environment-network protocols

    OpenAIRE

    Fessl, Jaromír

    2011-01-01

    Work is focused on network protocols features and security characteristics. Overview of protocols is made through all layers of OSI model and by this design structured. For each layer is made summary of interesting facts. Separate chapter is dedicated for VPN and for implementation possibilities of VPN. In chapter Practical problems are reflected most important problems of actual security (from network protocol point of view) concerned on SSL/TLS, SMTP and DNS. Together with security charact...

  18. Security analysis of session initiation protocol

    OpenAIRE

    Dobson, Lucas E.

    2010-01-01

    Approved for public release; distribution is unlimited The goal of this thesis is to investigate the security of the Session Initiation Protocol (SIP). This was accomplished by researching previously discovered protocol and implementation vulnerabilities, evaluating the current state of security tools and using those tools to discover new vulnerabilities in SIP software. The CVSS v2 system was used to score protocol and implementation vulnerabilities to give them a meaning that was us...

  19. VULNERABILITIES OF THE SSL/TLS PROTOCOL

    OpenAIRE

    Jelena Ćurguz

    2016-01-01

    This paper analyzes vulnerabilities of the SSL/TLS Handshake protocol, which is responsible for authentication of the parties in the communication and negotiation of security parameters that will be used to protect confidentiality and integrity of the data. It will be analyzed the attacks against the implementation of Handshake protocol, as well as the attacks against the other elements necessary to SSL/TLS protocol to discover security flaws that were exploited, modes of attac...

  20. Security Aspects of Distance-Bounding Protocols

    OpenAIRE

    Onete, Maria Cristina

    2012-01-01

    Authentication protocols, run between a so-called prover and a so-called verifier, enable the verifier to decide whether a prover is legitimate or not. Such protocols enable access control, and are used in e.g.~logistics, public transport, or personal identification. An authentication protocol is considered secure if an adversary cannot impersonate a legitimate prover. Such an adversary may eavesdrop authentication attempts between a legitimate prover and a legitimate verifier, interact with ...

  1. SCRUTINY OF BROADCASTING PROTOCOLS IN VANET

    OpenAIRE

    Rohini Nere; Uma Nagaraj

    2015-01-01

    Definitive broadcasting in vehicular ad hoc networks is the key to success for various services and applications on an intelligent transportation system. Many trusted broadcasting protocols have been proposed but none of them has been evaluated in realistic scenario. In this paper, we discuss these reliable broadcasting protocols on VANET. Basic mechanism in broadcasting, and also we are providing collective research of Broadcasting protocols in vanet in that some real time protoc...

  2. Emission trading under the Kyoto Protocol

    OpenAIRE

    Holtsmark, Bjart; Hagem, Cathrine

    2003-01-01

    On 11 December 1997, delegates to the third conference of the Parties to the UN Framework Convention on Climate Change agreed upon the Kyoto Protocol. The protocol sets binding emission targets for developed nations (Annex B countries). The Protocol states that Annex B countries may participate in emission trading. The rules for emission trading are to be discussed at the fourth Conference of the Parties in November 1998. differentiation of targets among countries, but not in any system...

  3. Enhancements to A Lightweight RFID Authentication Protocol

    CERN Document Server

    Zhang, Xiaowen; Wei, Xinzhou

    2008-01-01

    Vajda and Buttyan (VB) proposed a set of five lightweight RFID authentication protocols. Defend, Fu, and Juels (DFJ) did cryptanalysis on two of them - XOR and SUBSET. To the XOR protocol, DFJ proposed repeated keys attack and nibble attack. In this paper, we identify the vulnerability existed in the original VB's successive session key permutation algorithm. We propose three enhancements to prevent DFJ's attacks and make XOR protocol stronger without introducing extra resource cost.

  4. Failure of Kak quantum key distribution protocol

    Indian Academy of Sciences (India)

    Ching-Nung Yang; Su-Hsuan Chu; Bing-Ling Lu

    2005-01-01

    Kak's quantum key distribution (QKD) protocol provides not only the distribution but also the integrity of secret key simultaneously in quantum channel. Consequently the additional exchange of information, used to check whether an eavesdropper exists, is unnecessary. In this comment, we will point out the failure of Kak's protocol and show that Kak's protocol does not have the joint distribution and integration that the author declares in [1].

  5. VANET Routing Protocols: Pros and Cons

    OpenAIRE

    Paul, Bijan; Ibrahim, Md.; Bikas, Md. Abu Naser

    2012-01-01

    VANET (Vehicular Ad-hoc Network) is a new technology which has taken enormous attention in the recent years. Due to rapid topology changing and frequent disconnection makes it difficult to design an efficient routing protocol for routing data among vehicles, called V2V or vehicle to vehicle communication and vehicle to road side infrastructure, called V2I. The existing routing protocols for VANET are not efficient to meet every traffic scenarios. Thus design of an efficient routing protocol h...

  6. Optimizing One Fair Document Exchange Protocol

    OpenAIRE

    Alaraj, Abdullah M.

    2012-01-01

    This paper presents an efficient fair document exchange protocol. The exchange of the documents will be between two parties. The protocol is based on the verifiable and recoverable encryption of a document's key. This verifiable and recoverable encryption of the document's key will allow one party to verify the encrypted key. It will also ensure this party that the Semi Trusted Third Party will be able to recover the key if the other party misbehaves. The protocol also incorporates the concep...

  7. An Identity- Based Key- Exchange Protocol

    Institute of Scientific and Technical Information of China (English)

    ZHANG Ya-juan; ZHU Yue-fei; HUANG Qiu-sheng

    2005-01-01

    An identity-based key-exchange protocol using a bilinear map is proposed and it is proved SK-secure(session key secure) in the AM (authenticated links adversarial model)provided the BDDH (bilinear Diffie-Hellmen) assumption is correct. Then we apply the signature-based authenticator to our protocol and obtain an identity-Based key-exchange protocol that is SK-secure in the UM (unauthenticated links adversarial model) provided the BDDH assumption is correct.

  8. CIMS Network Protocol and Its Net Models

    Institute of Scientific and Technical Information of China (English)

    罗军舟; 顾冠群

    1997-01-01

    Computer communication network architectures for cims are based on the OSI Reference Model.In this paper,CIMS network protocol model is set up on the basis of the corresqonding service model.Then the authors present a formal specification of transport protocols by using an extended Predicate/Transition net system that is briefly introduced in the third part.Finally,the general methods for the Petri nets based formal specification of CIMS network protocols are outlined.

  9. Vulnerabilities in Quantum Key Distribution Protocols

    OpenAIRE

    Kuhn, D. Richard

    2003-01-01

    Recently proposed quantum key distribution protocols are shown to be vulnerable to a classic man-in-the-middle attack using entangled pairs created by Eve. It appears that the attack could be applied to any protocol that relies on manipulation and return of entangled qubits to create a shared key. The protocols that are cryptanalyzed in this paper were proven secure with respect to some eavesdropping approaches, and results reported here do not invalidate these proofs. Rather, they suggest th...

  10. Security Protocol Verification: Symbolic and Computational Models

    OpenAIRE

    Blanchet, Bruno

    2012-01-01

    Security protocol verification has been a very active research area since the 1990s. This paper surveys various approaches in this area, considering the verification in the symbolic model, as well as the more recent approaches that rely on the computational model or that verify protocol implementations rather than specifications. Additionally, we briefly describe our symbolic security protocol verifier ProVerif and situate it among these approaches.

  11. A Formal Approach to Protocol Performance Testing

    Institute of Scientific and Technical Information of China (English)

    XU Mingwei; WU Jianping

    1999-01-01

    This paper proposes a formal approach to protocol performance testing based on the extended concurrent TTCN. To meet the needs of protocol performance testing, concurrent TTCN is extended, and the extended concurrent TTCN's operational semantics is defined in terms of Input-Output Labeled Transition System. An architecture design of protocol performance test system is described, and an example of test cases and its test resultare given.

  12. Rewriting-Based Verification of Authentication Protocols

    OpenAIRE

    Ogata, Kazuhiro; Futatsugi, Kokichi

    2004-01-01

    We propose a method of formally analysing security protocols based on rewriting. The method is roughly as follows. A security protocol is modeled as an observational transition system, which is described in CafeOBJ. Proof scores showing that the protocol has safety (security) properties are then written in CafeOBJ and the proof scores are executed (rewritten) by the CafeOBJ system.

  13. Software for simulating IMRT protocol

    International Nuclear Information System (INIS)

    The Intensity Modulated Radiation Therapy - IMRT is an advanced technique to cancer treatment widely used on oncology around the world. The present paper describes the SOFT-RT software which is a tool for simulating IMRT protocol. Also, it will be present a cerebral tumor case of studied in which three irradiation windows with distinct orientation were applied. The SOFT-RT collect and export data to MCNP code. This code simulates the photon transport on the voxel model. Later, a out-module from SOFT-RT import the results and express the dose-response superimposing dose and voxel model in a tree-dimensional graphic representation. The present paper address the IMRT software and its function as well a cerebral tumor case of studied is showed. The graphic interface of the SOFT-RT illustrates the example case. (author)

  14. E-Cash Payment Protocols

    Directory of Open Access Journals (Sweden)

    Shweta Srivastava

    2012-09-01

    Full Text Available E-cash is a payment system designed and implemented for making purchases over open networks such as the Internet. Need of a payment system which enables the electronic transactions are growing at the same time that the use of Internet is growing in our daily life. Present days electronic payment systems have a major problem, they cannot handle the security and the users anonymity and at the same time these systems are secure on the cost of their users anonymity. This paper shows the payment protocols for digital cash and discusses how a digital cash system can be formed by presenting a few of the present days digital cash systems in details. We also provide a comparison and determine them together to see which one of them fulfils the properties for digital cash and the required security level.

  15. Hiro Hirai's BAC-FISH Protocol

    OpenAIRE

    sprotocols

    2014-01-01

    Author: Schistosoma Genome Network ### Overview This protocol is a modification of the standard FISH protocol published by Hiro Hirai and Phil LoVerde in Parasitology Today (1995, 11(8) p 310-314) that has been optimised for use with BAC probes and should be read in conjunction with the published protocol. This protocol uses the BIOPRIME reaction kit from GibcoBRL to prepare biotin-labelled BAC DNA which is detected using FITC-Avidin (Vector Labs, DCS grade). Reagents from other ...

  16. Attack strategies on quantum cryptographic protocols

    International Nuclear Information System (INIS)

    Full text: Quantum key distribution (QKD) and quantum authentication (QA) have been a topic of extensive research in the last 20 years. In course of that many attacks on QKD and QA protocols have been studied. Among these, Zhang, Lee and Guo presented an attack on a QKD protocol using entanglement swapping. Based on that strategy we take a look at other protocols to inspect how much information an adversary may get if he shares entanglement with either one or both parties. We will present some protocols where an adversary can even get full information about the key using entanglement. (author)

  17. Mac protocols for cyber-physical systems

    CERN Document Server

    Xia, Feng

    2015-01-01

    This book provides a literature review of various wireless MAC protocols and techniques for achieving real-time and reliable communications in the context of cyber-physical systems (CPS). The evaluation analysis of IEEE 802.15.4 for CPS therein will give insights into configuration and optimization of critical design parameters of MAC protocols. In addition, this book also presents the design and evaluation of an adaptive MAC protocol for medical CPS, which exemplifies how to facilitate real-time and reliable communications in CPS by exploiting IEEE 802.15.4 based MAC protocols. This book wil

  18. Efficient secure two-party protocols

    CERN Document Server

    Hazay, Carmit

    2010-01-01

    The authors present a comprehensive study of efficient protocols and techniques for secure two-party computation -- both general constructions that can be used to securely compute any functionality, and protocols for specific problems of interest. The book focuses on techniques for constructing efficient protocols and proving them secure. In addition, the authors study different definitional paradigms and compare the efficiency of protocols achieved under these different definitions.The book opens with a general introduction to secure computation and then presents definitions of security for a

  19. Equilibria of Generalized Cut and Choose Protocols

    DEFF Research Database (Denmark)

    Branzei, Simina; Caragiannis, Ioannis; Kurokawa, David; Procaccia, Ariel

    Classic cake cutting protocols — which fairly allocate a divisible good among agents with heterogeneous preferences — are susceptible to manipulation. Do their strategic outcomes still guarantee fairness? To answer this question we adopt a novel algo rithmic approach, proposing a concrete...... computational model and reasoning about the game-theoretic properties of algorithms that operate in this model. Specifically, we show that each protocol in the class of generalized cut and choose (GCC) protocols — which includes the most important discrete cake cutting protocols — is guaranteed to have...

  20. A formal model of fair exchange protocols

    Institute of Scientific and Technical Information of China (English)

    QING Sihan; LI Gaicheng

    2005-01-01

    Based on the study of existing fair exchange protocols, this paper sets up an accurate formal model by stepwise refinement. In the process of refinement an unreliable channel is employed to simulate an attack behavior. The model provides a novel formal definition of exchanged items, and presents the formal goals for fairness, accountability,etc., reflecting the inherent requirements for fair exchange protocols across-the-board. In order to check, prove, and design fair exchange protocols effectively and efficiently, the model puts forward a novel property of abuse-freeness which applies to all fair exchange protocols, gives a formal definition for trust strand of the third party, and presents general criteria of designing a secure and effective fair exchange protocol. Taking a typical fair exchange protocol as an example, this paper presents the analysis steps of fair exchange protocols appealing to our model. An unknown attack is uncovered. The analysis reveals the process of a complete attack, discovering deeper reasons for causing an attack.Finally, we modify the flawed protocol and the revised protocol ensures the desirable properties.