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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. 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

  3. 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)

  4. Clinical protocol for assessment and management in dental trauma

    OpenAIRE

    Maria Carolina Bandeira Macena; Ana Catarina Leite; Viviane Colares; Sandra vieira; Luiz Guedes de Carvalho Neto

    2009-01-01

    Objective: To present a clinical protocol based on current literature in order to optimize the emergency care of dental trauma in deciduous and permanent dentition. Methods: A documental study held by means of literature review of studies available in the following data basis: MEDLINE, Cochrane, Pubmed, Lilacs, and BBO SCIELO, using as keywords: dental injury, classification, diagnosis and epidemiology. The protocols produced by the International Association of Dental Trauma (IADT) and the Am...

  5. 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

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

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    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.

  7. 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

  8. 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...

  9. 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

  10. 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.)

  11. 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.)

  12. 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...

  13. 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

  14. 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.

  15. 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

  16. Axon clinical chemistry analyzer evaluated according to ECCLS protocol.

    Science.gov (United States)

    Brenna, S; Prencipe, L

    1992-10-01

    We assessed the analytical performance of the Axon system (Bayer Diagnostici), according to the European Committee for Clinical Laboratory Standards guidelines, for assay of 12 analytes: cholesterol, creatinine, glucose, total protein, urea, uric acid, alkaline phosphatase, alpha-amylase, aspartate aminotransferase, creatine kinase, sodium, and potassium. The field evaluation lasted approximately 5 months and involved the collection of approximately 10,000 data points with the Axon. The following results were obtained: The highest CVs for controls and human sera at different concentration/activity values were 2.2% for within-run imprecision (n = 60; 3 days, pooled estimate) and 3.5% for the between-day imprecision (n = 20 days). Close correlation was found with results for patients' specimens assayed with comparative instruments (Hitachi 717 for substrates and enzymes, Beckman Synchron EL/E4A for electrolytes). No drift was observed during 8 h of operation. The linearity range was broad, sometimes exceeding the manufacturer's claims. No sample-, reagent-, or cuvette-related carryover was found. Measurement of control sera gave results within +/- 5% of the assigned values. We conclude that good reliability and practicability make the Axon system suitable for laboratories with various needs.

  17. Determinants of tinnitus’ impact in Quality of Life in an outpatient clinic protocol.

    NARCIS (Netherlands)

    Magali Roggerone, [No Value

    2010-01-01

    Summary Background: Tinnitus is a chronic condition that can cause substantial handicap for certain patients and affects their Quality of Life. Our study focuses on Quality of Life for the tinnitus patients who participated in the protocol of an outpatient clinic established at the ENT department of

  18. A new Hydrocephalus Clinical Research Network protocol to reduce cerebrospinal fluid shunt infection.

    Science.gov (United States)

    Kestle, John R W; Holubkov, Richard; Douglas Cochrane, D; Kulkarni, Abhaya V; Limbrick, David D; Luerssen, Thomas G; Jerry Oakes, W; Riva-Cambrin, Jay; Rozzelle, Curtis; Simon, Tamara D; Walker, Marion L; Wellons, John C; Browd, Samuel R; Drake, James M; Shannon, Chevis N; Tamber, Mandeep S; Whitehead, William E

    2016-04-01

    OBJECT In a previous report by the same research group (Kestle et al., 2011), compliance with an 11-step protocol was shown to reduce CSF shunt infection at Hydrocephalus Clinical Research Network (HCRN) centers (from 8.7% to 5.7%). Antibiotic-impregnated catheters (AICs) were not part of the protocol but were used off protocol by some surgeons. The authors therefore began using a new protocol that included AICs in an effort to reduce the infection rate further. METHODS The new protocol was implemented at HCRN centers on January 1, 2012, for all shunt procedures (excluding external ventricular drains [EVDs], ventricular reservoirs, and subgaleal shunts). Procedures performed up to September 30, 2013, were included (21 months). Compliance with the protocol and outcome events up to March 30, 2014, were recorded. The definition of infection was unchanged from the authors' previous report. RESULTS A total of 1935 procedures were performed on 1670 patients at 8 HCRN centers. The overall infection rate was 6.0% (95% CI 5.1%-7.2%). Procedure-specific infection rates varied (insertion 5.0%, revision 5.4%, insertion after EVD 8.3%, and insertion after treatment of infection 12.6%). Full compliance with the protocol occurred in 77% of procedures. The infection rate was 5.0% after compliant procedures and 8.7% after noncompliant procedures (p = 0.005). The infection rate when using this new protocol (6.0%, 95% CI 5.1%-7.2%) was similar to the infection rate observed using the authors' old protocol (5.7%, 95% CI 4.6%-7.0%). CONCLUSIONS CSF shunt procedures performed in compliance with a new infection prevention protocol at HCRN centers had a lower infection rate than noncompliant procedures. Implementation of the new protocol (including AICs) was associated with a 6.0% infection rate, similar to the infection rate of 5.7% from the authors' previously reported protocol. Based on the current data, the role of AICs compared with other infection prevention measures is unclear.

  19. 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.

  20. 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

  1. Randomized trial for answers to clinical questions: Evaluating a pre-appraised versus a MEDLINE search protocol

    Science.gov (United States)

    Patel, Manesh R.; Schardt, Connie M.; Sanders, Linda L.; Keitz, Sheri A.

    2006-01-01

    Objective: The paper compares the speed, validity, and applicability of two different protocols for searching the primary medical literature. Design: A randomized trial involving medicine residents was performed. Setting: An inpatient general medicine rotation was used. Participants: Thirty-two internal medicine residents were block randomized into four groups of eight. Main Outcome Measures: Success rate of each search protocol was measured by perceived search time, number of questions answered, and proportion of articles that were applicable and valid. Results: Residents randomized to the MEDLINE-first (protocol A) group searched 120 questions, and residents randomized to the MEDLINE-last (protocol B) searched 133 questions. In protocol A, 104 answers (86.7%) and, in protocol B, 117 answers (88%) were found to clinical questions. In protocol A, residents reported that 26 (25.2%) of the answers were obtained quickly or rated as “fast” (<5 minutes) as opposed to 55 (51.9%) in protocol B, (P = 0.0004). A subset of questions and articles (n = 79) were reviewed by faculty who found that both protocols identified similar numbers of answer articles that addressed the questions and were felt to be valid using critical appraisal criteria. Conclusion: For resident-generated clinical questions, both protocols produced a similarly high percentage of applicable and valid articles. The MEDLINE-last search protocol was perceived to be faster. However, in the MEDLINE-last protocol, a significant portion of questions (23%) still required searching MEDLINE to find an answer. PMID:17082828

  2. 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

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

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    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.

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

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    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.

  5. 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...

  6. A conceptual framework and protocol for defining clinical decision support objectives applicable to medical specialties

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    Timbie Justin W

    2012-09-01

    Full Text Available Abstract Background The U.S. Centers for Medicare and Medicaid Services established the Electronic Health Record (EHR Incentive Program in 2009 to stimulate the adoption of EHRs. One component of the program requires eligible providers to implement clinical decision support (CDS interventions that can improve performance on one or more quality measures pre-selected for each specialty. Because the unique decision-making challenges and existing HIT capabilities vary widely across specialties, the development of meaningful objectives for CDS within such programs must be supported by deliberative analysis. Design We developed a conceptual framework and protocol that combines evidence review with expert opinion to elicit clinically meaningful objectives for CDS directly from specialists. The framework links objectives for CDS to specialty-specific performance gaps while ensuring that a workable set of CDS opportunities are available to providers to address each performance gap. Performance gaps may include those with well-established quality measures but also priorities identified by specialists based on their clinical experience. Moreover, objectives are not constrained to performance gaps with existing CDS technologies, but rather may include those for which CDS tools might reasonably be expected to be developed in the near term, for example, by the beginning of Stage 3 of the EHR Incentive program. The protocol uses a modified Delphi expert panel process to elicit and prioritize CDS meaningful use objectives. Experts first rate the importance of performance gaps, beginning with a candidate list generated through an environmental scan and supplemented through nominations by panelists. For the highest priority performance gaps, panelists then rate the extent to which existing or future CDS interventions, characterized jointly as “CDS opportunities,” might impact each performance gap and the extent to which each CDS opportunity is compatible with

  7. A proposed protocol for the standardized preparation of PRF membranes for clinical use.

    Science.gov (United States)

    Kobayashi, Mito; Kawase, Tomoyuki; Horimizu, Makoto; Okuda, Kazuhiro; Wolff, Larry F; Yoshie, Hiromasa

    2012-09-01

    Upon clinical application, thick platelet-rich fibrin (PRF) is usually compressed to fit the implantation site. However, it is speculated that the preservation of platelets and plasma content depends on the compression methods used. To accurately evaluate the clinical outcome of PRF, the preparation protocol should be standardized. Freshly prepared PRF clots were compressed into a thin membrane by our novel PRF compression device. The localization of platelets was examined by SEM and immunostaining. Growth factor levels were evaluated by bioassays and cytokine-antibody array techniques. The angiogenic activity was examined by the chick chorioallantoic membrane assay and the scratch assay using HUVEC cultures. Platelets were concentrated on the surface of the region adjacent to the red thrombus and this region was subjected to the experiments. Compared to the PRF membrane compressed by dry gauze (G-PRF), the preservation of the plasma content, 3D-fibrin meshwork, and platelets was more intact in the compressor-prepared PRF membrane (C-PRF). Among the growth factors tested, C-PRF contained PDGF isoforms at higher levels, and significantly stimulated cell proliferation and neovascularization. C-PRF may be useful for grafting while minimizing the loss of bioactive factors. This C-PRF preparation protocol is proposed as a standardized protocol for PRF membrane preparation.

  8. 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.

  9. 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

  10. Diversity in clinical management and protocols for the treatment of major bleeding trauma patients across European level I Trauma Centres

    DEFF Research Database (Denmark)

    Schäfer, Nadine; Driessen, Arne; Fröhlich, Matthias;

    2015-01-01

    centre provided their locally applied massive transfusion protocol. RESULTS: All participating trauma centres have developed and implemented a local algorithm and protocol for the bleeding trauma patient. These are uniformly activated by clinical triggers and deactivated once the bleeding has stopped...... according to clinical assessment in combination with laboratory signs of achieved haemostasis. The severity of coagulopathy and shock is mostly assessed via standard coagulation tests and partially used extended viscoelastic tests. All centres have implemented the immediate use of tranexamic acid. Initial...

  11. 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 ...

  12. A clinical protocol to increase chewing and assess mastication in children with feeding disorders.

    Science.gov (United States)

    Volkert, Valerie M; Peterson, Kathryn M; Zeleny, Jason R; Piazza, Cathleen C

    2014-09-01

    Children with feeding disorders often cannot or do not chew when presented with table food. Children with chewing deficits also often swallow the bite before masticating it appropriately, which we will refer to as early swallowing. In the current study, we evaluated a clinical protocol to increase chews per bite, assess mastication, and eliminate early swallowing with three children with feeding disorders. The current study adds to a small body of literature on chewing and mastication of children with feeding disorders. Suggestions for future research are also discussed. PMID:24902589

  13. 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

  14. 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

  15. Clinical gait analysis for amputees: innovation wishlist and the perspectives offered by the outwalk protocol.

    Science.gov (United States)

    Cutti, Andrea Giovanni; Raggi, Michele; Andreoni, Giuseppe; Sacchetti, Rinaldo

    2015-01-01

    Clinical gait analysis (CGA) has shown potentials for the prosthetics field and has been found effective for scientific purposes and to design general rehabilitation models. However, intrinsic limitations of the "artificial" laboratory environment usually result in recording performances not representative patients' real-life gait. In order to promote the diffusion of CGA in the clinical decision-making process, a framework for developing novel, more ecological CGA applications is presented. Moreover, the Outwalk protocol, based on wearable sensors and developed within this framework guidelines, is described and validated for its inter-rater agreement on a population of transtibial amputees walking in a real-life scenario. Results show the possibility of drawing precise conclusions over different aspects of amputees' gait and prostheses' performance in every-day life conditions.

  16. 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

  17. 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

  18. Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

    Science.gov (United States)

    Ahmed, Khaled; Kyte, Derek; Keeley, Thomas; Efficace, Fabio; Armes, Jo; Brown, Julia M; Calman, Lynn; Copland, Chris; Gavin, Anna; Glaser, Adam; Greenfield, Diana M; Lanceley, Anne; Taylor, Rachel; Velikova, Galina; Brundage, Michael; Mercieca-Bebber, Rebecca; King, Madeleine T

    2016-01-01

    Introduction Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points. Methods and analysis Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion. Ethics and dissemination The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer

  19. 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...

  20. Should the entire clinical trial protocol always be translated into the local investigators' first language?

    Directory of Open Access Journals (Sweden)

    Liz Wager

    2008-06-01

    Full Text Available On the basis of her professional experience with clinical trial documentation for multinational pharmaceutical industries and not-for-profit organisms, the author argues that the motivation to read the clinical trial protocol closely may be compromised if the information is not in the reader's native language. Vital instructions about running the trial correctly may be misunderstood, and physicians may find it difficult to answer participants' questions clearly if they find it hard to understand the information provided in English. She concludes that it is vital that the complete protocol be available in the investigators' native (or at least working language. ----------------------------------------------- ¿Debería traducirse siempre todo el protocolo al primer idioma de los investigadores? Basándose en su experiencia profesional con la documentación relacionada con los ensayos clínicos para empresas farmacéuticas multinacionales y organismos sin ánimo de lucro, la autora propone que la motivación de leer el protocolo de un ensayo clínico con atención puede verse comprometida si la información no se presenta en el primer idioma del lector. Cabe la posibilidad de que se interpreten mal las instrucciones para la implementación del ensayo, y los médicos pueden encontrar dificultades a la hora de responder con precisión a las preguntas de los participantes, si aquellos tienen problemas a la hora de entender la información proporcionada en inglés. La autora concluye que es de vital importancia que el protocolo entero esté disponible en el primer idioma del investigador, o por lo menos en su idioma habitual de trabajo.

  1. 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

  2. [Development of clinical trial education program for pharmaceutical science students through small group discussion and role-playing using protocol].

    Science.gov (United States)

    Imakyure, Osamu; Shuto, Hideki; Nishikawa, Fumi; Hagiwara, Yoshifuka; Inoue, Sachiko; Koyanagi, Taeko; Hirakawa, Masaaki; Kataoka, Yasufumi

    2010-08-01

    The acquirement of basic knowledge of clinical trials and professional attitude in their practices is a general instructional objective in the Model Core Curriculum for Pharmaceutical Education. Unfortunately, the previous program of clinical trial education was not effective in the acquirement of a professional attitude in their practices. Then, we developed the new clinical trial education program using protocol through small group discussion (SGD) and roll-playing. Our program consists of 7 steps of practical training. In step 1, the students find some problems after presentation of the protocol including case and prescription. In step 2, they analyse the extracted problems and share the information obtained in SGD. In steps 3 and 5, five clinical case scenarios are presented to the students and they discuss which case is suitable for entry to the clinical trial or which case corresponds to the discontinuance criteria in the present designed protocol. In steps 4 and 6, the roll-playing is performed by teachers and students as doctors and clinical research coordinators (CRC) respectively. Further, we conducted a trial practice based on this program for the students. In the student's self-evaluation into five grades, the average score of the skill acquisition level in each step was 3.8-4.7 grade. Our clinical trial education program could be effective in educating the candidates for CRC or clinical pharmacists.

  3. 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.

  4. 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

  5. Practical way to develop 10-color flow cytometry protocols for the clinical laboratory

    Science.gov (United States)

    Tárnok, Attila; Bocsi, Jozsef

    2010-02-01

    The latest development of commercial routine flow cytometers (FCM) is that they are equipped with three (blue, red, violet) or more lasers and many PMT detectors. Nowadays routine clinical instruments are capable of detecting 10 or more fluorescence colors simultaneously. Thereby, presenting opportunities for getting detailed information on the single cell level for cytomics and systems biology for improve diagnostics and monitoring of patients. The University Leipzig, Germany) recently started a cluster of excellence to study the molecular background of life style and environment associated diseases, enrolling 25000 individuals (LIFE). To this end the most comprehensive FCM protocol has to be developed for this study. We aimed to optimize fluorochrome and antibody combinations to the characteristics of the instrument for successful 10-color FCM. Systematic review of issues related to sampling, preparation, instrument settings, spillover and compensation matrix, reagent performance, and general principles of panel construction was performed. 10-color FCM enables for increased accuracy in cell subpopulation identification, the ability to obtain detailed information from blood specimens, improved laboratory efficiency, and the means to consistently detect major and rare cell populations. Careful attention to details of instrument and reagent performance allows for the development of panels suitable for screening of samples from healthy and diseased donors. The characteristics of this technique are particularly well suited for the analysis of broad human population cohorts and have the potential to reach the everyday practice in a standardized way for the clinical laboratory.

  6. 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.)

  7. 'Outwalk': a protocol for clinical gait analysis based on inertial and magnetic sensors.

    Science.gov (United States)

    Cutti, Andrea Giovanni; Ferrari, Alberto; Garofalo, Pietro; Raggi, Michele; Cappello, Angelo; Ferrari, Adriano

    2010-01-01

    A protocol named Outwalk was developed to easily measure the thorax-pelvis and lower-limb 3D kinematics on children with cerebral palsy (CP) and amputees during gait in free-living conditions, by means of an Inertial and Magnetic Measurement System (IMMS). Outwalk defines the anatomical/functional coordinate systems (CS) for each body segment through three steps: (1) positioning the sensing units (SUs) of the IMMS on the subjects' thorax, pelvis, thighs, shanks and feet, following simple rules; (2) computing the orientation of the mean flexion-extension axis of the knees; (3) measuring the SUs' orientation while the subject's body is oriented in a predefined posture, either upright or supine. If the supine posture is chosen, e.g. when spasticity does not allow to maintain the upright posture, hips and knees static flexion angles must be measured through a standard goniometer and input into the equations that define Outwalk anatomical CSs. In order to test for the inter-rater measurement reliability of these angles, a study was carried out involving nine healthy children (7.9 +/- 2 years old) and two physical therapists as raters. Results showed RMS error of 1.4 degrees and 1.8 degrees and a negligible worst-case standard error of measurement of 2.0 degrees and 2.5 degrees for hip and knee angles, respectively. Results were thus smaller than those reported for the same measures when performed through an optoelectronic system with the CAST protocol and support the beginning of clinical trials of Outwalk with children with CP.

  8. Oropharyngeal dysphagia, free water protocol and quality of life: an update from a prospective clinical trial.

    Science.gov (United States)

    Karagiannis, Martha; Karagiannis, Tom C

    2014-01-01

    Oropharyngeal dysphagia, typically associated with older adults, represents a spectrum of swallowing disorders with potentially serious complications and a negative impact on quality of life. A major complication of dysphagia is caused by aspiration, predominantly of thin liquids, which may cause aspiration pneumonia. Given that thin liquids are typically aspirated, the conventional therapy involves altering the diet to one consisting of modified solid consistencies and thickened fluids. While it is well known that this approach is appropriate for aspiration, it does represent difficulties with compliancy and quality of life. We have undertaken a relatively large scale clinical trial to investigate the relationships between the effects of free access to water and the development of aspiration, aspects of hydration and issues related to quality in people with dysphagia. Along with clinical observations and findings from others we have previously stratified people with dysphagia, namely those that are immobile or who have low mobility and severe degenerative neurological dysfunction, at highest risk of developing aspiration pneumonia following intake of water. In the present study, we have extended our previous clinical results. Our findings indicate that following purposeful selection of people with dysphagia with their own mobility and relatively healthy cognitive function, free access to water did not result in aspiration pneumonia, improved measures of hydration and in particular, significantly increased quality of life when compared to a diet consisting of thickened fluids only. Overall, we conclude that in people with good mobility and cognitive ability, there is no need to deviate from the Frazier Rehabilitation Centre free water protocol, which allows for the provision of water to people with dysphagia with strict guidelines particularly in relation to good physical ability.

  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. 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

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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

  16. 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

  17. 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.

  18. 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...

  19. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

    2016-01-01

    the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. METHODS AND FINDINGS: We received...... the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on Pub...... group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of seven papers stated that "all adverse events were recorded." For one trial, we identified an additional 1...

  20. 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

  1. 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.

  2. 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.)

  3. 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.)

  4. Clinical applicability and cutoff values for an unstructured neuropsychological assessment protocol for older adults with low formal education.

    Directory of Open Access Journals (Sweden)

    Jonas Jardim de Paula

    Full Text Available BACKGROUND AND OBJECTIVES: The neuropsychological exam plays a central role in the assessment of elderly patients with cognitive complaints. It is particularly relevant to differentiate patients with mild dementia from those subjects with mild cognitive impairment. Formal education is a critical factor in neuropsychological performance; however, there are few studies that evaluated the psychometric properties, especially criterion related validity, neuropsychological tests for patients with low formal education. The present study aims to investigate the validity of an unstructured neuropsychological assessment protocol for this population and develop cutoff values for clinical use. METHODS AND RESULTS: A protocol composed by the Rey-Auditory Verbal Learning Test, Frontal Assessment Battery, Category and Letter Fluency, Stick Design Test, Clock Drawing Test, Digit Span, Token Test and TN-LIN was administered to 274 older adults (96 normal aging, 85 mild cognitive impairment and 93 mild Alzheimer`s disease with predominantly low formal education. Factor analysis showed a four factor structure related to Executive Functions, Language/Semantic Memory, Episodic Memory and Visuospatial Abilities, accounting for 65% of explained variance. Most of the tests showed a good sensitivity and specificity to differentiate the diagnostic groups. The neuropsychological protocol showed a significant ecological validity as 3 of the cognitive factors explained 31% of the variance on Instrumental Activities of Daily Living. CONCLUSION: The study presents evidence of the construct, criteria and ecological validity for this protocol. The neuropsychological tests and the proposed cutoff values might be used for the clinical assessment of older adults with low formal education.

  5. 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

  6. Apyrase treatment of myocardial infarction according to a clinically applicable protocol fails to reduce myocardial injury in a porcine model

    Directory of Open Access Journals (Sweden)

    Otto Andreas

    2010-01-01

    Full Text Available Abstract Background Ectonucleotidase dependent adenosine generation has been implicated in preconditioning related cardioprotection against ischemia-reperfusion injury, and treatment with a soluble ectonucleotidase has been shown to reduce myocardial infarct size (IS when applied prior to induction of ischemia. However, ectonucleotidase treatment according to a clinically applicable protocol, with administration only after induction of ischemia, has not previously been evaluated. We therefore investigated if treatment with the ectonucleotidase apyrase, according to a clinically applicable protocol, would reduce IS and microvascular obstruction (MO in a large animal model. Methods A percutaneous coronary intervention balloon was inflated in the left anterior descending artery for 40 min, in 16 anesthetized pigs (40-50 kg. The pigs were randomized to 40 min of 1 ml/min intracoronary infusion of apyrase (10 U/ml, n = 8 or saline (0.9 mg/ml, n = 8, twenty minutes after balloon inflation. Area at risk (AAR was evaluated by ex vivo SPECT. IS and MO were evaluated by ex vivo MRI. Results No differences were observed between the apyrase group and saline group with respect to IS/AAR (75.7 ± 4.2% vs 69.4 ± 5.0%, p = NS or MO (10.7 ± 4.8% vs 11.4 ± 4.8%, p = NS, but apyrase prolonged the post-ischemic reactive hyperemia. Conclusion Apyrase treatment according to a clinically applicable protocol, with administration of apyrase after induction of ischemia, does not reduce myocardial infarct size or microvascular obstruction.

  7. 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

  8. 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

  9. 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...

  10. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis

    Science.gov (United States)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I.; Gøtzsche, Peter C.

    2016-01-01

    Background Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. Methods and Findings We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were “bothersome,” a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc

  11. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis

    Science.gov (United States)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I.; Gøtzsche, Peter C.

    2016-01-01

    Background Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. Methods and Findings We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were “bothersome,” a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc

  12. 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

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

    OpenAIRE

    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...

  14. Updating magnetic resonance imaging of small bowel: Imaging protocols and clinical indications

    Institute of Scientific and Technical Information of China (English)

    Jiong Zhu; Jian-Rong Xu; Hong-Xia Gong; Yan Zhou

    2008-01-01

    High soft tissue contrast resolution,acquisition of multi-planar images and the possibility to obtain functional information make magnetic resonance an interesting imaging technique to evaluate the small bowel disease.The absence of ionizing radiation is an important feature of magnetic resonance imaging (MRI) examinations because inflammatory diseases such as Crohn's disease (CD) are studied most frequently,which are prevalent among children and young adults.MRI,using modern equipment and a rigorous technical approach,can offer detailed morphologic information and functional data on the small bowel.This article discusses the MRI protocols for small bowel and the MR imaging findings of small bowel diseases,such as CD and small bowel neoplasms.

  15. Using a clinical protocol for orthognathic surgery and assessing a 3-dimensional virtual approach: current therapy.

    Science.gov (United States)

    Quevedo, Luis A; Ruiz, Jessica V; Quevedo, Cristobal A

    2011-03-01

    Oral and maxillofacial surgeons who perform orthognathic surgery face major changes in their practices, and these challenges will increase in the near future, because the extraordinary advances in technology applied to our profession are not only amazing but are becoming the standard of care as they promote improved outcomes for our patients. Orthognathic surgery is one of the favorite areas of practicing within the scope of practice of an oral and maxillofacial surgeon. Our own practice in orthognathic surgery has completed over 1,000 surgeries of this type. Success is directly related to the consistency and capability of the surgical-orthodontic team to achieve predictable, stable results, and our hypothesis is that a successful result is directly related to the way we take our records and perform diagnosis and treatment planning following basic general principles. Now that we have the opportunity to plan and treat 3-dimensional (3D) problems with 3D technology, we should enter into this new era with appropriate standards to ensure better results, instead of simply enjoying these new tools, which will clearly show not only us but everyone what we do when we perform orthognathic surgery. Appropriate principles need to be taken into account when implementing this new technology. In other words, new technology is welcome, but we do not have to reinvent the wheel. The purpose of this article is to review the current protocol that we use for orthognathic surgery and compare it with published protocols that incorporate new 3D and virtual technology. This report also describes our approach to this new technology.

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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.

  1. PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial [ISCRTN 74418480].

    NARCIS (Netherlands)

    E.J. van Breda (Eric); H.B. van der Worp (Bart); H.M.A. van Gemert (Maarten); A. Algra (Ale); L.J. Kappelle (Jaap); J. van Gijn (Jan); P.J. Koudstaal (Peter Jan); D.W.J. Dippel (Diederik)

    2005-01-01

    textabstractBACKGROUND: In patients with acute stroke, increased body temperature is associated with large lesion volumes, high case fatality, and poor functional outcome. A 1 degrees C increase in body temperature may double the odds of poor outcome. Two randomized double-blind clinical trials in p

  2. 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.

  3. 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

  4. Analysis of Requirements for the Medication Profile to Be Used in Clinical Research: Protocol Feasibility Studies and Patient Recruitment

    Directory of Open Access Journals (Sweden)

    Julie M. James

    2015-01-01

    Full Text Available A “Medication Profile,” the information about the medicines a person is using and has used, is a core part of many electronic health record systems and summaries. However, there is little objective research into the data elements that the profile should contain to support the uses it must serve. With the increasing emphasis on secondary uses of electronic health information, as well as supporting the requirements to support direct to patient care, the Medication Profile should also support the requirements from clinical research. However, there is little, if any, description of these available. This paper describes an analysis of a set of study eligibility criteria that was undertaken to investigate which medication-related data elements would be required to support two clinical research use cases: the parameters to query a patient’s Medication Profile to assess their suitability for entry into a trial (patient recruitment and the parameters to query a set of Medication Profiles in a data warehouse to assess whether the eligibility criteria as described would yield a reasonable cohort of patients as potential subjects (protocol feasibility. These medication-related data elements then become information requirements that a Medication Profile should ideally meet, in order to be able to support these two uses in the clinical research domain.

  5. 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.

  6. 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...

  7. 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...

  8. Ahmedabad tolerance induction protocol and chronic renal allograft dysfunction: pathologic observations and clinical implications

    Directory of Open Access Journals (Sweden)

    Trivedi Hargovind L

    2009-01-01

    Full Text Available Abstract Background Chronic Renal Allograft Dysfunction (CRAD is responsible for a large number of graft failures. We have abrogated acute T-cell rejections using Ahmedabad Tolerance Induction Protocol (ATIP with hematopoietic stem cell transplantation (HSCT under non-myeloablative conditioning pre-transplant. However B-cell mediated rejections and CRAD continue to haunt us. We carried out retrospective analysis of renal allograft biopsies performed in the last 4 years to evaluate the effect of ATIP on CRAD. Materials and methods Biopsies diagnosed as per modified Banff criteria belonged to 2 groups: ATIP under low dose immunosuppression of cyclosporine/Azathioprine/Mycofenolate mofetil+ Prednisolone, subjected to donor leucocyte transfusion, anti-T/B cell antibodies, low dose target specific irradiation, cyclophosphamide, cyclosporin followed by HSCT pre-transplant; controls who opted out of ATIP were transplanted under standard triple drug immunosuppression. Demographics of both groups were comparable. Results Incidence of chronic changes was higher in controls (17.5% vs. 10.98% in ATIP over a mean follow up of 151.9 months in the former and 130.9 months in the latter. Proteinuria and hypertension were higher in controls (48.4% vs. ATIP (32.7% with chronic transplant glomerulopathy, focal global sclerosis in 67.7% in controls vs. 46.7% in ATIP, acute on chronic T/B cell rejection in 51.6% controls vs. 28.1% ATIP, with peritubular capillary C4d deposits in 19.4% controls vs. 1.9% ATIP biopsies. Acute on chronic calcineurin inhibitor toxicity was higher in ATIP (71.9% vs. 48.4% in controls. Conclusion Chronic immune injury was less with ATIP vs controls as compared to a higher incidence of chronic calcineurin inhibitor toxicity in the former.

  9. EXACKTE2: Exploiting the clinical consultation as a knowledge transfer and exchange environment: a study protocol

    Directory of Open Access Journals (Sweden)

    Ouimet Mathieu

    2009-03-01

    Full Text Available Abstract Background While the evidence suggests that the way physicians provide information to patients is crucial in helping patients decide upon a course of action, the field of knowledge translation and exchange (KTE is silent about how the physician and the patient influence each other during clinical interactions and decision-making. Consequently, based on a novel relationship-centered model, EXACKTE2 (EXploiting the clinicAl Consultation as a Knowledge Transfer and Exchange Environment, this study proposes to assess how patients and physicians influence each other in consultations. Methods We will employ a cross-sectional study design involving 300 pairs of patients and family physicians from two primary care practice-based research networks. The consultation between patient and physician will be audio-taped and transcribed. Following the consultation, patients and physicians will complete a set of questionnaires based on the EXACKTE2 model. All questionnaires will be similar for patients and physicians. These questionnaires will assess the key concepts of our proposed model based on the essential elements of shared decision-making (SDM: definition and explanation of problem; presentation of options; discussion of pros and cons; clarification of patient values and preferences; discussion of patient ability and self-efficacy; presentation of doctor knowledge and recommendation; and checking and clarifying understanding. Patients will be contacted by phone two weeks later and asked to complete questionnaires on decisional regret and quality of life. The analysis will be conducted to compare the key concepts in the EXACKTE2 model between patients and physicians. It will also allow the assessment of how patients and physicians influence each other in consultations. Discussion Our proposed model, EXACKTE2, is aimed at advancing the science of KTE based on a relationship process when decision-making has to take place. It fosters a new KTE

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

    Directory of Open Access Journals (Sweden)

    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

  11. The Newcastle 85+ study: biological, clinical and psychosocial factors associated with healthy ageing: study protocol

    Directory of Open Access Journals (Sweden)

    Martin-Ruiz Carmen

    2007-06-01

    Full Text Available Abstract Background The UK, like other developed countries, is experiencing a marked change in the age structure of its population characterised by increasing life expectancy and continuing growth in the older fraction of the population. There is remarkably little up-to-date information about the health of the oldest old (over 85 years, demographically the fastest growing section of the population. There is a need, from both a policy and scientific perspective, to describe in detail the health status of this population and the factors that influence individual health trajectories. For a very large proportion of medical conditions, age is the single largest risk factor. Gaining new knowledge about why aged cells and tissues are more vulnerable to pathology is likely to catalyse radical new insights and opportunities to intervene. The aims of the Newcastle 85+ Study are to expose the spectrum of health within an inception cohort of 800 85 year-olds; to examine health trajectories and outcomes as the cohort ages and their associations with underlying biological, medical and social factors; and to advance understanding of the biological nature of ageing. Methods A cohort of 800 85 year olds from Newcastle and North Tyneside will be recruited at baseline and followed until the last participant has died. Eligible individuals will be all those who turn 85 during the year 2006 (i.e. born in 1921 and who are registered with a Newcastle or North Tyneside general practice. Participants will be visited in their current residence (own home or institution by a research nurse at baseline, 18 months and 36 months. The assessment protocol entails a detailed multi-dimensional health assessment together with review of general practice medical records. Participants will be flagged with the NHS Central Register to provide details of the date and cause of death. Discussion The Newcastle 85+ Study will address key questions about health and health-maintenance in the

  12. 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.)

  13. 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.

  14. 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

  15. 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

  16. A knowledge synthesis of patient and public involvement in clinical practice guidelines: study protocol

    Directory of Open Access Journals (Sweden)

    Tapp Sylvie

    2009-06-01

    Full Text Available Abstract Background Failure to reconcile patient preferences and values as well as social norms with clinical practice guidelines (CPGs recommendations may hamper their implementation in clinical practice. However, little is known about patients and public involvement programs (PPIP in CPGs development and implementation. This study aims at identifying what it is about PPIP that works, in which contexts are PPIP most likely to be effective, and how are PPIP assumed to lead to better CPGs development and implementation. Methods and design A knowledge synthesis will be conducted in four phases. In phase one, literature on PPIP in CPGs development will be searched through bibliographic databases. A call for bibliographic references and unpublished reports will also be sent via the mailing lists of relevant organizations. Eligible publications will include original qualitative, quantitative, or mixed methods study designs reporting on a PPIP pertaining to CPGs development or implementation. They will also include documents produced by CPGs organizations to describe their PPIP. In phase two, grounded in the program's logic model, two independent reviewers will extract data to collect information on the principal components and activities of PPIP, the resources needed, the contexts in which PPIP were developed and tested, and the assumptions underlying PPIP. Quality assessment will be made for all retained publications. Our literature search will be complemented with interviews of key informants drawn from of a purposive sample of CPGs developers and patient/public representatives. In phase three, we will synthesize evidence from both the publications and interviews data using template content analysis to organize the identified components in a meaningful framework of PPIP theories. During a face-to-face workshop, findings will be validated with different stakeholder and a final toolkit for CPGs developers will be refined. Discussion The proposed

  17. 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

  18. The effectiveness of a health promotion with group intervention by clinical trial. Study protocol

    Directory of Open Access Journals (Sweden)

    Campo Osaba Maria-Antonia

    2012-03-01

    Full Text Available Abstract Background The promotion of health and the interventions in community health continue to be one of the pending subjects of our health system. The most prevalent health problems (cardiovascular diseases, cancer, diabetes... are for the most part related to life habits. We propose a holistic and integral approach as the best option for tackling behavior and its determinants. The research team has elaborated the necessary educational material to realize group teaching, which we call "Health Workshops". The goal of the present study is to evaluate the effectiveness of these Health Workshops in the following terms: Health Related Quality of Life (HRQOL, incorporate and maintain a balanced diet, do physical activity regularly, maintain risk factors such as tension, weight, cholesterol within normal limits and diminish cardiovascular risk. Methods/Design Controlled and random clinical testing, comparing a group of persons who have participated in the Health Workshops with a control group of similar characteristics who have not participated in the Health Workshops. Field of study: the research is being done in Health Centers of the city of Barcelona, Spain. Population studied: The group is composed of 108 persons that are actually doing the Health Workshops, and 108 that are not and form the control group. They are assigned at random to one group or the other. Data Analysis: With Student's t-distribution test to compare the differences between numerical variables or their non parametric equivalent if the variable does not comply with the criteria of normality. (Kolmogorov-Smirnof test. Chi-square test to compare the differences between categorical variables and the Logistic Regression Model to analyze different meaningful variables by dichotomous analysis related to the intervention. Discussion The Health Workshop proposed in the present study constitutes an innovative approach in health promotion, placing the emphasis on the person's self

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

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    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

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

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    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

  1. 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.

  2. 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.

  3. Clinical Study of Endostar Combined with DP Protocol in Treatment of Advanced Esophageal Cancer

    Directory of Open Access Journals (Sweden)

    Wen-ying DENG

    2015-09-01

    Full Text Available Objective: To observe the clinical outcomes of Endostar combined with DP regimen for treating advanced esophageal cancer.Methods: A total of 62 patients with advanced esophageal cancer admitted from May, 2011 to May, 2013 were enrolled for a prospective, randomized controlled trial and 2 cases were excluded from the study because of Ⅳ degree of digestive tract reaction and myelosuppression. Therefore, 60 cases could be evaluated, and then divided into combined group (given Endostar+DP plan and single chemotherapy group, 30 cases in each group. The level of VEGF, tumor size and CT perfusion (CTP parameters, including blood flow (BF, blood volume (BV, mean transit time (MTT, and permeability surface (PS before and after treatment were determined for comparison. Kaplan-Merier method was used to analyze the overall survival (OS of 2 groups.Results: The efficacy of combined group was superior to single chemotherapy group. The level of vascular endothelial growth factor (VEGF in combined group was obviously lower than that in single chemotherapy group after treatment (P<0.01. Compared with treatment before in combined group, BF, BV and PS decreased while MTT increased after treatment (P<0.05. However, there were no significant differences in single chemotherapygroup before and after treatment (P>0.05. The median OS was 30 months (95%CI: 20.935-39.065 for combined group and 21 months (95%CI: 15.109-26.591 for single chemotherapy group, respectively (P=0.048. The 1-, 2- and 3-year survival rates were 86.2%, 59.3% and 36.6% in combined group, and 70.8%, 32.1% and 17.8% in single chemotherapy group, respectively.Conclusion: Endostar can down-regulate the expression of VEGF, improve the state of hypertransfusion and high permeability of tumor vessels, has better curative effect without slighter adverse reactions, and prolong the survival time of patients with advanced esophageal cancer when combined with chemotherapy.

  4. Clinical Study of Endostar Combined with DP Protocol in Treatment of Advanced Esophageal Cancer

    Institute of Scientific and Technical Information of China (English)

    DENG Wen-ying; LI Ning; LUO Su-xia

    2015-01-01

    Objective: To observe the clinical outcomes of Endostar combined with DP regimen for treating advanced esophageal cancer. Methods: A total of 62 patients with advanced esophageal cancer admitted from May, 2011 to May, 2013 were enrolled for a prospective, randomized controlled trial and 2 cases were excluded from the study because ofⅣ degree of digestive tract reaction and myelosuppression. Therefore, 60 cases could be evaluated, and then divided into combined group (given Endostar+DP plan) and single chemotherapy group, 30 cases in each group. The level of VEGF, tumor size and CT perfusion (CTP) parameters, including blood flow (BF), blood volume (BV), mean transit time (MTT), and permeability surface (PS) before and after treatment were determined for comparison. Kaplan-Merier method was used to analyze the overall survival (OS) of 2 groups. Results:The efifcacy of combined group was superior to single chemotherapy group. The level of vascular endothelial growth factor (VEGF) in combined group was obviously lower than that in single chemotherapy group after treatment (P0.05). The median OS was 30 months (95%CI: 20.935-39.065) for combined group and 21 months (95%CI: 15.109-26.591) for single chemotherapy group, respectively (P=0.048). The 1-, 2- and 3-year survival rates were 86.2%, 59.3% and 36.6% in combined group, and 70.8%, 32.1% and 17.8% in single chemotherapy group, respectively. Conclusion: Endostar can down-regulate the expression of VEGF, improve the state of hypertransfusion and high permeability of tumor vessels, has better curative effect without slighter adverse reactions, and prolong the survival time of patients with advanced esophageal cancer when combined with chemotherapy.

  5. 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...

  6. 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.

  7. The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol

    Directory of Open Access Journals (Sweden)

    Fukuoka Yoshimi

    2011-12-01

    Full Text Available Abstract Background Despite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED (mobile phone based physical activity education randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions. Methods A randomized controlled trial (RCT with three arms; 1 PLUS (3-month mobile phone and pedometer based physical activity intervention and 6-month mobile phone diary maintenance intervention, 2 REGULAR (3-month mobile phone and pedometer based physical activity intervention and 6-month pedometer maintenance intervention, and 3 CONTROL (pedometer only, but no intervention will be conducted. A total of 192 physically inactive women who meet all inclusion criteria and successfully complete a 3-week run-in will be randomized into one of the three groups. The mobile phone serves as a means of delivering the physical activity intervention, setting individualized weekly physical activity goals, and providing self-monitoring (activity diary, immediate feedback and social support. The mobile phone also functions as a tool for communication and real-time data capture. The primary outcome is objectively measured physical activity. Discussion If efficacy of the intervention with a mobile phone is demonstrated, the results of this RCT will be able to provide new insights for current behavioral

  8. 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

    , 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...

  9. 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

  10. 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

  11. Optimization and clinical validation of a Real-Time PCR protocol for direct detection of Trichomonas vaginalis in pooled urine samples

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    WHA Zandijk

    2009-12-01

    Full Text Available Background and Objectives: A new Real- Time PCR protocol for the detection of Trichomonas vaginalis in pooled urine"nsamples has been optimized and validated."nMaterials and Methods: The amplification protocol, targeting a 2kb repeated gene in the T. vaginalis genome, was optimized"nby varying PCR parameters. As a reference method, a Real-Time PCR protocol targeting the beta-tubulin gene (Y. Versluis"net al, 2006, Int J STD AIDS 17:642 was used. Clinical validation was performed with pooled urine samples obtained from"npatients of the sexually transmitted diseases clinic of a university hospital (n=963; from February – June 2007."nResults: Positive samples with the new optimized technique is 1.1% (n=10, while the beta-tubulin real-time PCR method"ngenerated four positives (0.3%."nConclusion: The new RT- PCR protocol is a sensitive (1.000 and specific (0.993 procedure to detect and to identify T."nvaginalis in urine samples.

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

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    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

  13. 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...

  14. 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

  15. Low-dose single acquisition rest {sup 99m}Tc/stress {sup 201}Tl myocardial perfusion SPECT protocol: phantom studies and clinical validation

    Energy Technology Data Exchange (ETDEWEB)

    Dey, Thomas [RWTH Aachen University, Institute of Imaging and Computer Vision, Aachen (Germany); Backus, Barbra E.; Romijn, R.Leo [St. Antonius Hospital, Department of Nuclear Medicine, Nieuwegein (Netherlands); Wieczorek, Herfried [Philips Research, Eindhoven (Netherlands); Verzijlbergen, J.F. [St. Antonius Hospital, Department of Nuclear Medicine, Nieuwegein (Netherlands); Erasmus Medical Center, Department of Nuclear Medicine, Rotterdam (Netherlands)

    2014-03-15

    We developed and tested a single acquisition rest {sup 99m}Tc-sestamibi/stress {sup 201}Tl dual isotope protocol (SDI) with the intention of improving the clinical workflow and patient comfort of myocardial perfusion single photon emission computed tomography (SPECT). The technical feasibility of SDI was evaluated by a series of anthropomorphic phantom studies on a standard SPECT camera. The attenuation map was created by a moving transmission line source. Iterative reconstruction including attenuation correction, resolution recovery and Monte Carlo simulation of scatter was used for simultaneous reconstruction of dual tracer distribution. For clinical evaluation, patient studies were compared to stress {sup 99m}Tc and rest {sup 99m}Tc reference images acquired in a 2-day protocol. Clinical follow-up examinations like coronary angiography (CAG) and fractional flow reserve (FFR) were included in the assessment if available. Phantom studies demonstrated the technical feasibility of SDI. Artificial lesions inserted in the phantom mimicking ischaemia could be clearly identified. In 51/53 patients, the image quality was adequate for clinical evaluation. For the remaining two obese patients with body mass index > 32 the injected {sup 201}Tl dose of 74 MBq was insufficient for clinical assessment. In answer to this the {sup 201}Tl dose was adapted for obese patients in the rest of the study. In 31 patients, SDI and {sup 99m}Tc reference images resulted in equivalent clinical assessment. Significant differences were found in 20 patients. In 18 of these 20 patients additional examinations were available. In 15 patients the diagnosis based on the SDI images was confirmed by the results of CAG or FFR. In these patients the SDI images were more accurate than the {sup 99m}Tc reference study. In three patients minor ischaemic lesions were detected by SDI but were not confirmed by CAG. In one of these cases this was probably caused by pronounced apical thinning. For two patients

  16. Revised Recommendations of the Consortium of MS Centers Task Force for a Standardized MRI Protocol and Clinical Guidelines for the Diagnosis and Follow-Up of Multiple Sclerosis

    Science.gov (United States)

    Traboulsee, A.; Simon, J.H.; Stone, L.; Fisher, E.; Jones, D.E.; Malhotra, A.; Newsome, S.D.; Oh, J.; Reich, D.S.; Richert, N.; Rammohan, K.; Khan, O.; Radue, E.-W.; Ford, C.; Halper, J.; Li, D.

    2016-01-01

    SUMMARY An international group of neurologists and radiologists developed revised guidelines for standardized brain and spinal cord MR imaging for the diagnosis and follow-up of MS. A brain MR imaging with gadolinium is recommended for the diagnosis of MS. A spinal cord MR imaging is recommended if the brain MR imaging is nondiagnostic or if the presenting symptoms are at the level of the spinal cord. A follow-up brain MR imaging with gadolinium is recommended to demonstrate dissemination in time and ongoing clinically silent disease activity while on treatment, to evaluate unexpected clinical worsening, to re-assess the original diagnosis, and as a new baseline before starting or modifying therapy. A routine brain MR imaging should be considered every 6 months to 2 years for all patients with relapsing MS. The brain MR imaging protocol includes 3D T1-weighted, 3D T2-FLAIR, 3D T2-weighted, post-single-dose gadolinium-enhanced T1-weighted sequences, and a DWI sequence. The progressive multifocal leukoencephalopathy surveillance protocol includes FLAIR and DWI sequences only. The spinal cord MR imaging protocol includes sagittal T1-weighted and proton attenuation, STIR or phase-sensitive inversion recovery, axial T2- or T2*-weighted imaging through suspicious lesions, and, in some cases, postcontrast gadolinium-enhanced T1-weighted imaging. The clinical question being addressed should be provided in the requisition for the MR imaging. The radiology report should be descriptive, with results referenced to previous studies. MR imaging studies should be permanently retained and available. The current revision incorporates new clinical information and imaging techniques that have become more available. PMID:26564433

  17. Effectiveness of individualized physiotherapy on pain and functioning compared to a standard exercise protocol in patients presenting with clinical signs of subacromial impingement syndrome. A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    de Bie Rob A

    2010-06-01

    Full Text Available Abstract Background Shoulder impingement syndrome is a common musculoskeletal complaint leading to significant reduction of health and disability. Physiotherapy is often the first choice of treatment although its effectiveness is still under debate. Systematic reviews in this field highlight the need for more high quality trials to investigate the effectiveness of physiotherapy interventions in patients with subacromial impingement syndrome. Methods/Design This randomized controlled trial will investigate the effectiveness of individualized physiotherapy in patients presenting with clinical signs and symptoms of subacromial impingement, involving 90 participants aged 18-75. Participants are recruited from outpatient physiotherapy clinics, general practitioners, and orthopaedic surgeons in Germany. Eligible participants will be randomly allocated to either individualized physiotherapy or to a standard exercise protocol using central randomization. The control group will perform the standard exercise protocol aiming to restore muscular deficits in strength, mobility, and coordination of the rotator cuff and the shoulder girdle muscles to unload the subacromial space during active movements. Participants of the intervention group will perform the standard exercise protocol as a home program, and will additionally be treated with individualized physiotherapy based on clinical examination results, and guided by a decision tree. After the intervention phase both groups will continue their home program for another 7 weeks. Outcome will be measured at 5 weeks and at 3 and 12 months after inclusion using the shoulder pain and disability index and patients' global impression of change, the generic patient-specific scale, the average weekly pain score, and patient satisfaction with treatment. Additionally, the fear avoidance beliefs questionnaire, the pain catastrophizing scale, and patients' expectancies of treatment effect are assessed. Participants

  18. 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

    are collected at baseline and at follow-up as well as weekly, using SMS text messages. DISCUSSION: This study investigates a manual strategy (chiropractic maintenance care) for recurrent and persistent LBP and aims to answer questions regarding the effect and cost-effectiveness of this preventive approach...... 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...

  19. 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

  20. The recolonization hypothesis in a full-mouth or multiple-session treatment protocol : a blinded, randomized clinical trial

    NARCIS (Netherlands)

    Zijnge, Vincent; Meijer, Henriette F.; Lie, Mady-Ann; Tromp, Jan A. H.; Degener, John E.; Harmsen, Hermie J. M.; Abbas, Frank

    2010-01-01

    P>Aim To test recolonization of periodontal lesions after full-mouth scaling and root planing (FM-SRP) or multiple session-SRP (MS-SRP) in a randomized clinical trial and whether FM-SRP and MS-SRP result in different clinical outcomes. Materials and Methods Thirty-nine subjects were randomly assigne

  1. 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

  2. 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.

  3. 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

  4. 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

  5. Clinical and surgical risk factors in the development of proliferative vitreoretinopathy following retinal detachment surgery: a systematic review protocol

    OpenAIRE

    Chaudhary, Rishika; Dretzke, Janine; Scott, Robert; Logan, Ann; Blanch, Richard

    2016-01-01

    Background Proliferative vitreoretinopathy (PVR) is a known complication of retinal detachment surgery. It has been postulated that the establishment of PVR involves inflammatory and ischaemic processes. Surgical and clinical risk factors contribute to making certain patients more vulnerable to developing PVR. The objective of this systematic review is to identify and appraise the evidence on clinical and surgical risk factors and their utility in predicting the occurrence or worsening of PVR...

  6. 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.

  7. Neutron dosimetry for low dose rate Cf-252 AT sources and adherence to recent clinical dosimetry protocol for brachytherapy

    Energy Technology Data Exchange (ETDEWEB)

    Rivard, M.J.; Wierzbicki, J.G.; Van den Heuvel, F. [Wayne State Univ., Detroit, MI (United States). Dept. of Radiation Oncology; Martin, R.C. [Oak Ridge National Lab., TN (United States). Chemical Technology Div.

    1997-12-01

    In 1995, the American Association of Physicists in Medicine Task Group 43 (AAPM TG-43) published a protocol obsoleting all mixed-field radiation dosimetry for Cf-252. Recommendations for a new brachytherapy dosimetry formalism made by this Task Group favor quantification of source strength in terms of air kerma rather than apparent Curies or other radiation units. Additionally, representation of this dosimetry data in terms of radial dose functions, anisotropy functions, geometric factors, and dose rate constants are in an angular and radial (spherical) coordinate system as recommended, rather than the along-away dosimetry data (Cartesian coordinate system) currently available. This paper presents the initial results of calculated neutron dosimetry in a water phantom for a Cf-252 applicator tube (AT) type medical source soon available from Oak Ridge National Laboratory (ORNL).

  8. An exploration of the role of pharmacists within general practice clinics: the protocol for the pharmacists in practice study (PIPS

    Directory of Open Access Journals (Sweden)

    Tan Edwin

    2012-08-01

    Full Text Available Abstract Background Medication-related problems are a serious concern in Australian primary care. Pharmacist interventions have been shown to be effective in identifying and resolving these problems. Collaborative general practitioner-pharmacist services currently available in Australia are limited and underused. Limitations include geographical isolation of pharmacists and lack of communication and access to patient information. Co-location of pharmacists within the general practice clinics is a possible solution. There have been no studies in the Australian setting exploring the role of pharmacists within general practice clinics. The aim of this study is to develop and test a multifaceted practice pharmacist role in primary care practices to improve the quality use of medicines by patients and clinic staff. Methods/design This is a multi-centre, prospective intervention study with a pre-post design and a qualitative component. A practice pharmacist will be located in each of two clinics and provide short and long patient consultations, drug information services and quality assurance activities. Patients receiving long consultation with a pharmacist will be followed up at 3 and 6 months. Based on sample size calculations, at least 50 patients will be recruited for long patient consultations across both sites. Outcome measures include the number, type and severity of medication-related problems identified and resolved; medication adherence; and patient satisfaction. Brief structured interviews will be conducted with patients participating in the study to evaluate their experiences with the service. Staff collaboration and satisfaction with the service will be assessed. Discussion This intervention has the potential to optimise medication use in primary care clinics leading to better health outcomes. This study will provide data about the effectiveness of the proposed model for pharmacist involvement in Australian general practice clinics

  9. 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

  10. 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

  11. A computer-assisted protocol for endovascular target interventions using a clinical MRI system for controlling untethered microdevices and future nanorobots.

    Science.gov (United States)

    Martel, Sylvain; Mathieu, Jean-Baptiste; Felfoul, Ouajdi; Chanu, Arnaud; Aboussouan, Eric; Tamaz, Samer; Pouponneau, Pierre; Yahia, L'Hocine; Beaudoin, Gilles; Soulez, Gilles; Mankiewicz, Martin

    2008-11-01

    The possibility of automatically navigating untethered microdevices or future nanorobots to conduct target endovascular interventions has been demonstrated by our group with the computer-controlled displacement of a magnetic sphere along a pre-planned path inside the carotid artery of a living swine. However, although the feasibility of propelling, tracking and performing real-time closed-loop control of an untethered ferromagnetic object inside a living animal model with a relatively close similarity to human anatomical conditions has been validated using a standard clinical Magnetic Resonance Imaging (MRI) system, little information has been published so far concerning the medical and technical protocol used. In fact, such a protocol developed within technological and physiological constraints was a key element in the success of the experiment. More precisely, special software modules were developed within the MRI software environment to offer an effective tool for experimenters interested in conducting such novel interventions. These additional software modules were also designed to assist an interventional radiologist in all critical real-time aspects that are executed at a speed beyond human capability, and include tracking, propulsion, event timing and closed-loop position control. These real-time tasks were necessary to avoid a loss of navigation control that could result in serious injury to the patient. Here, additional simulation and experimental results for microdevices designed to be targeted more towards the microvasculature have also been considered in the identification, validation and description of a specific sequence of events defining a new computer-assisted interventional protocol that provides the framework for future target interventions conducted in humans.

  12. 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

  13. 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.

  14. 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

  15. 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 ...

  16. 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

  17. Understanding the relationship between the perceived characteristics of clinical practice guidelines and their uptake: protocol for a realist review

    Directory of Open Access Journals (Sweden)

    Grimshaw Jeremy

    2011-07-01

    Full Text Available Abstract Background Clinical practice guidelines have the potential to facilitate the implementation of evidence into practice, support clinical decision making, specify beneficial therapeutic approaches, and influence public policy. However, these potential benefits have not been consistently achieved. The limited impact of guidelines can be attributed to organisational constraints, the complexity of the guidelines, and the lack of usability testing or end-user involvement in their development. Implementability has been referred to as the perceived characteristics of guidelines that predict the relative ease of their implementation at the clinical level, but this concept is as yet poorly defined. The objective of our study is to identify guideline attributes that affect uptake in practice by considering evidence from four disciplines (medicine, psychology, management, human factors engineering to determine the relationship between the perceived characteristics of recommendations and their uptake and to develop a framework of implementability. Methods A realist-review approach to knowledge synthesis will be used to understand attributes of guidelines (e.g., its text and content and how changing these elements might impact clinical practice and clinical decision making. It also allows for the exploration of 'what works for whom, in what circumstances, and in what respects'. The realist review will be structured according to Pawson's five practical steps in realist reviews: (1 clarifying the scope of the review, (2 determining the search strategy, (3 ensuring proper article selection and study quality assessment, (4 extracting and organising data, and (5 synthesising the evidence and drawing conclusions. Data will be synthesised according to a two-stage analysis: (1 we will extract and define all relevant guideline attributes from the different disciplines, then create a shortlist of unique attributes and investigate their relationships with

  18. 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.

  19. 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...

  20. 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

  1. 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

  2. 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.

  3. Translating stem cell research to the clinic: a primer on translational considerations for your first stem cell protocol.

    Science.gov (United States)

    O'Brien, Timothy; Creane, Michael; Windebank, Anthony J; Terzic, Andre; Dietz, Allan B

    2015-08-22

    Over the last two decades, a new therapeutic paradigm has emerged which has changed the way debilitating diseases may be treated in the future. Instead of using small-molecule drugs and devices to ameliorate the symptoms of disease, clinicians may harness the therapeutic power of cells to regenerate and cure diseases which currently represent a major unmet medical need. Advancements in the scientific knowledge of stem cell biology, along with highly encouraging preclinical proof-of-concept studies, in the last several years have served as a launch pad for testing such therapeutics in humans with life-threatening diseases. However, translating basic research findings into human therapy has not been straightforward and has presented many scientific, clinical, and regulatory challenges for scientists and clinicians. In this article, we provide a guidance framework for investigators for the design of early-phase clinical studies using stem cell-based therapeutics. Furthermore, important trial parameters and design features which must be considered before regulatory submission of such studies are highlighted.

  4. 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

  5. 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

  6. Effect of different financial competing interest statements on readers' perceptions of clinical educational articles: study protocol for a randomised controlled trial

    Science.gov (United States)

    Schroter, Sara; Pakpoor, Julia; Morris, Julie; Chew, Mabel; Godlee, Fiona

    2016-01-01

    Introduction Financial ties with industry are varied and common among academics, doctors and institutions. Clinical educational articles are intended to guide patient care and convey authors' own interpretation of selected data. Author biases in educational articles tend to be less visible to readers compared to those in research papers. Little is known about which types of competing interest statements affect readers' interpretation of the credibility of these articles. This study aims to investigate how different competing interest statements in educational articles affect clinical readers' perceptions of the articles. Methods and analysis 2040 doctors who are members of the British Medical Association (BMA) and receive a copy of the British Medical Journal (The BMJ) each week will be randomly selected and invited by an email to participate in the study. They will be randomised to receive 1 of 2 Clinical Reviews, each with 1 of 4 possible competing interest statements. Versions of each review will be identical except for permutations of the competing interest statement. Study participants will be asked to read their article and complete an online questionnaire. The questionnaire will ask participants to rate their confidence in the conclusions drawn in the article, the importance of the article, their level of interest in the article and their likeliness to change their practice from the article. Factorial analyses of variance and analyses of covariance will be carried out to assess the impact of the type of competing interest statement and Clinical Review on level of confidence, importance, interest and likeliness to change practice. Ethics and dissemination The study protocol, questionnaire and letter of invitation to participants have been reviewed by members of The BMJ's Ethics Committee for ethical concerns. The trial results will be disseminated to participants and published in a peer-reviewed journal. Trial registration number NCT02548312; Pre

  7. 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

  8. 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

  9. A Robust Protocol for Using Multiplexed Droplet Digital PCR to Quantify Somatic Copy Number Alterations in Clinical Tissue Specimens

    Science.gov (United States)

    Hughesman, Curtis B.; Lu, X. J. David; Liu, Kelly Y. P.; Zhu, Yuqi; Poh, Catherine F.; Haynes, Charles

    2016-01-01

    The ability of droplet digital PCR (ddPCR) to accurately determine the concentrations of amplifiable targets makes it a promising platform for measuring copy number alterations (CNAs) in genomic biomarkers. However, its application to clinical samples, particularly formalin-fixed paraffin-embedded specimens, will require strategies to reliably determine CNAs in DNA of limited quantity and quality. When applied to cancerous tissue, those methods must also account for global genetic instability and the associated probability that the abundance(s) of one or more chosen reference loci do not represent the average ploidy of cells comprising the specimen. Here we present an experimental design strategy and associated data analysis tool that enables accurate determination of CNAs in a panel of biomarkers using multiplexed ddPCR. The method includes strategies to optimize primer and probes design to cleanly segregate droplets in the data output from reaction wells amplifying multiple independent templates, and to correct for bias from artifacts such as DNA fragmentation. We demonstrate how a panel of reference loci can be used to determine a stable CNA-neutral benchmark. These innovations, when taken together, provide a comprehensive strategy that can be used to reliably detect biomarker CNAs in DNA extracted from either frozen or FFPE tissue biopsies. PMID:27537682

  10. 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

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

    Science.gov (United States)

    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 or a limited period of supplementation. The aim of this trial is to investigate if intravenous glutamine supplementation to trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications and other secondary outcomes. Methods/design Eighty-eight critically ill patients with multiple trauma receiving enteral nutrition will be recruited in this prospective, triple-blind, block-randomised, placebo-controlled clinical trial to receive either 0.5 g/kg/day intravenous undiluted alanyl-glutamine or intravenous placebo by continuous infusion (24 h/day). Both groups will be receiving the same standard enteral nutrition protocol and the same standard intensive care unit care. Supplementation will continue until discharge from the intensive care unit, death or a maximum duration of 3 weeks. The primary outcome will be organ-dysfunction evaluation assessed by the pattern of change in sequential organ failure assessment score over a 10-day period. The secondary outcomes are: the changes in total sequential organ failure assessment score on the last day of treatment, infectious complications during the ICU stay, 60-day mortality, length of stay in the intensive care unit and body-composition analysis. Discussion This study is the first trial to investigate the effect of intravenous alanyl-glutamine supplementation in multiple trauma patients receiving enteral nutrition on reducing severity of organ

  12. 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.

  13. 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

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

    Science.gov (United States)

    McKenzie, Joanne E; French, Simon D; O'Connor, Denise A; Grimshaw, Jeremy M; Mortimer, Duncan; Michie, Susan; Francis, Jill; Spike, Neil; Schattner, Peter; Kent, Peter M; Buchbinder, Rachelle; Green, Sally E

    2008-01-01

    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 control arm will receive access

  15. 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

  16. Aneurysmal sizing after endovascular repair in patients with abdominal aortic aneurysm: interobserver variability of various measurement protocols and its clinical relevance

    Energy Technology Data Exchange (ETDEWEB)

    Abada, Hicham T.; Sapoval, Marc R.; Mousseaux, Elie; Gaux, Jean-Claude [Department of Cardiovascular and Interventional Radiology, Hopital Europeen Georges Pompidou, 20 rue Leblanc, 75015, Paris (France); Paul, Jean-Francois [Department of Cardiovascular and Interventional Radiology, Hopital Europeen Georges Pompidou, 20 rue Leblanc, 75015, Paris (France); Department of Radiology, Centre Chirugical Marie Lannelongue, 92350, Le Plessis-Robinson (France); De Maertelaer, Viviane [Statistical Unit, Interdisciplinary Research in Human Biology and Nuclear Medicine, University of Brussels, 1070, Brussels (Belgium)

    2003-12-01

    The aim of this study was to determine the variability of various measurement protocols for measurement of abdominal aortic aneurysm (AAA) and the clinical relevance of variability. Three radiologists performed computed tomographic angiography measurements of both the aorta and the largest portion of the aneurysm on selected axial slices. Then measurements of the largest portion of the aneurysm were performed on unselected axial slices, sagittal and coronal reformatted. Finally, aortic volume was calculated. Measurements and volume calculation were performed before and after endovascular repair and assessed: Part 1: interobserver variability for maximum anteroposterior (MAP) and maximum transverse (MTR) diameters on selected slices; part 2: interobserver variability for unselected slices considering MAP and MTR; part 3: interobserver variability considering maximum diameter in any direction (MAD); part 4: interobserver variability for sagittal (SAG) and coronal (COR) free curved multiplanar reformation (MPR); and part 5: volume calculations. We then determined which technique of measurement was the most clinically relevant for detecting changes in aneurysm size or aortic volume. Parts 1 and 2: interobserver variability was 4.1 mm for both MAP and MTR; part 3: interobserver variability was 7 mm for MAD; part 4: interobserver variability was 5.5 mm (COR) and 4.9 mm (SAG); part 5: interobserver variability for volume was 5.5 ml. A combination of MAP and MTR was the most useful for detecting aortic modification. Volume calculation was needed in only a few cases. We recommend avoiding MAD and MPR measurements and suggest instead measuring both maximum anteroposterior and maximum transverse diameters. If aneurysm size remains stable after endovascular repair, aneurysm volume should be measured. (orig.)

  17. 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

  18. Cryptographic Protocols:

    DEFF Research Database (Denmark)

    Geisler, Martin Joakim Bittel

    cryptography was thus concerned with message confidentiality and integrity. Modern cryptography cover a much wider range of subjects including the area of secure multiparty computation, which will be the main topic of this dissertation. Our first contribution is a new protocol for secure comparison, presented...... framework. We call this framework VIFF, short for Virtual Ideal Functionality Framework. VIFF implements a UC functionality for general multiparty computation on asynchronous networks. We give a formal definition of the functionality in Chapter 3. There we also describe how we implemented the functionality...... no information is released. The communication complexity of this protocol is the same as that of a passively secure solution up to a constant factor. It is secure against an adaptive and active adversary corrupting less than n=3 players. Following the presentation of VIFF, we turn to a more theoretical subject...

  19. 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.

  20. 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

  1. 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

  2. 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

  3. 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.....

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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 ...

  9. 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...

  10. 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

    DEFF Research Database (Denmark)

    Andersen, Mette Klarskov; Autio, Kirsi; Barbany, Gisela;

    2011-01-01

    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....... 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)....

  11. 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.

  12. 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...

  13. 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....

  14. 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.

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

    OpenAIRE

    Francis Jill; Michie Susan; Mortimer Duncan; Grimshaw Jeremy M; O'Connor Denise A; French Simon D; McKenzie Joanne E; Spike Neil; Schattner Peter; Kent Peter M; Buchbinder Rachelle; Green Sally E

    2008-01-01

    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...

  16. 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...

  17. 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...

  18. 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.

  19. 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

  20. 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

  1. Screening and brief interventions for hazardous and harmful alcohol use among patients with active tuberculosis attending primary care clinics in South Africa: a cluster randomized controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Naidoo Pamela P

    2011-05-01

    Full Text Available Abstract Background In 2008 the World Health Organization (WHO reported that South Africa had the highest tuberculosis (TB incidence in the world. This high incidence rate is linked to a number of factors, including HIV co-infection and alcohol use disorders. The diagnosis and treatment package for TB and HIV co-infection is relatively well established in South Africa. However, because alcohol use disorders may present more insidiously, making it difficult to diagnose, those patients with active TB and misusing alcohol are not easily cured from TB. With this in mind, the primary purpose of this cluster randomized controlled trial is to provide screening for alcohol misuse and to test the efficacy of brief interventions in reducing alcohol intake in those patients with active TB found to be misusing alcohol in primary health care clinics in three provinces in South Africa. Methods/Design Within each of the three selected health districts with the highest TB burden in South Africa, 14 primary health care clinics with the highest TB caseloads will be selected. Those agreeing to participate will be stratified according to TB treatment caseload and the type of facility (clinic or community health centre. Within strata from 14 primary care facilities, 7 will be randomly selected into intervention and 7 to control study clinics (42 clinics, 21 intervention clinics and 21 control clinics. At the clinic level systematic sampling will be used to recruit newly diagnosed TB patients. Those consenting will be screened for alcohol misuse using the AUDIT. Patients who screen positive for alcohol misuse over a 6-month period will be given either a brief intervention based on the Information-Motivation-Behavioural Skills (IMB Model or an alcohol use health education leaflet. A total sample size of 520 is expected. Discussion The trial will evaluate the impact of alcohol screening and brief interventions for patients with active TB in primary care settings in

  2. Protocol for the Quick Clinical study: a randomised controlled trial to assess the impact of an online evidence retrieval system on decision-making in general practice

    Directory of Open Access Journals (Sweden)

    Kidd Michael R

    2006-08-01

    Full Text Available Abstract Background Online information retrieval systems have the potential to improve patient care but there are few comparative studies of the impact of online evidence on clinicians' decision-making behaviour in routine clinical work. Methods/design A randomized controlled parallel design is employed to assess the effectiveness of an online evidence retrieval system, Quick Clinical (QC in improving clinical decision-making processes in general practice. Eligible clinicians are randomised either to receive access or not to receive access to QC in their consulting rooms for 12 months. Participants complete pre- and post trial surveys. Two-hundred general practitioners are recruited. Participants must be registered to practice in Australia, have a computer with Internet access in their consulting room and use electronic prescribing. Clinicians planning to retire or move to another practice within 12 months or participating in any other clinical trial involving electronic extraction of prescriptions data are excluded from the study. The primary end-points for the study is clinician acceptance and use of QC and the resulting change in decision-making behaviour. The study will examine prescribing patterns related to frequently prescribed medications where there has been a recent significant shift in recommendations regarding their use based upon new evidence. Secondary outcome measures include self-reported changes in diagnosis, patient education, prescriptions written, investigations and referrals. Discussion A trial under experimental conditions is an effective way of examining the impact of using QC in routine general practice consultations.

  3. 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

  4. 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

  5. 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

  6. 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.

  7. Induction cytotoxic chemotherapy: the significance of apparent complete clinical regression after using the Price Hill Schedule A protocol for squamous carcinoma of the head and neck.

    Science.gov (United States)

    Shaw, H J

    1988-12-01

    A small group of 46 previously untreated patients out of about 260 in all who have received Price Hill Schedule A cytotoxic chemotherapy, achieved apparent complete clinical regression (ACCR) of their disease before local treatment. Forty patients were classified T3 or T4, over half having clinically positive nodes at the start of treatment. A determinate survival rate of 70 per cent disease free at three years was obtained and 74 per cent achieved quality relief of all symptoms. Two patients declined local treatment and survived three years disease free after chemotherapy alone. No recurrence has occurred to date in seven patients achieving apparent complete histological regression (ACHR) in their surgical specimens. Although ACCR does not automatically improve prognosis it is likely that it does enhance the complete remission rate, especially for those also achieving ACHR. Benefits to patients obtaining ACCR with this minimally toxic chemotherapy schedule are listed. PMID:2465362

  8. 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;

    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....

  9. 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...

  10. Study protocol: a randomised placebo-controlled clinical trial to study the effect of vitamin D supplementation on glycaemic control in type 2 Diabetes Mellitus SUNNY trial

    OpenAIRE

    Krul-Poel, Yvonne HM; Wijland, Hans van; Stam, Frank; Ten Boekel, Edwin; Lips, Paul; Simsek, Suat

    2014-01-01

    Background Besides the classical role of vitamin D on calcium and bone homeostasis, vitamin D deficiency has recently been identified as a contributing factor in the onset of insulin resistance in type 2 diabetes mellitus. However, it is uncertain whether vitamin D deficiency and poor glycaemic control are causally interrelated or that they constitute two independent features of type 2 diabetes mellitus. There are limited clinical trials carried out which measured the effect of vitamin D supp...

  11. 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...

  12. 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...

  13. 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. ...

  14. 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...

  15. 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 ...

  16. 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.

  17. 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;

    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 ben...... 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....

  18. 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 all...

  19. Snakebite management in Iran: Devising a protocol

    Directory of Open Access Journals (Sweden)

    Seyed Mostafa Monzavi

    2014-01-01

    Full Text Available Background: Snakebite in Iran has been a health concern. However, management of snakebite is not standardized and varies from center to center. This study is aimed at devising an evidence-based comprehensive protocol for snakebite management in Iran, to reduce unnecessary variations in practice. Materials and Methods: A narrative search in electronic databases was performed. Fifty peer-reviewed articles, guidelines, and textbooks were reviewed and practical details were extracted. Our currently used protocol in the Mashhad Toxicology Center was supplemented with this information. Consequently an improved wide-range protocol was developed. The protocol was then discussed and amended within a focus group comprised of medical toxicologists and internal medicine specialists. The amended version was finally discussed with expert physicians specialized in different areas of medicine, to be optimized by supplementing other specific considerations. Results: During a one-year process, the protocol was finalized. The final version of the protocol, which was designed in six steps, comprised of three components: A schematic algorithm, a severity grading scale, and instructions for supportive and adjunctive treatments. The algorithm pertains to both Viperidae and Elapidae snakebite envenomations and consists of a planned course of action and dosing of antivenom, based on the severity of the envenomation. Conclusion: Snakebite envenomation is a clinical toxicologic emergency, which needs to be treated in a timely and organized manner. Hence, a multi-aspect protocol was designed to improve the clinical outcomes, reduce unnecessary administration of antivenom, and help physicians make more proper clinical judgments.

  20. 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.

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. ‘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

  7. 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

  8. 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

  9. A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Armstrong Natalie

    2012-09-01

    Full Text Available Abstract Background World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs rather than hospital specialists. Intermediate care clinics for diabetes (ICCD potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1 compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2 assess the cost-effectiveness of the intervention; and (3 explore the views and experiences of patients, health professionals and other stakeholders. Methods/Design This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention or to hospital care (control. Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or Control group: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%; blood pressure ( Discussion Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012

  10. 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

  11. 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

    weeks after randomisation. The primary outcome is change in the positive symptom score of the Positive and Negative Syndrome Scale. The recruitment period is 2010-2014. DISCUSSION: Antipsychotics are currently the only available pharmacologic treatments for psychotic disorders. However, information......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...

  12. 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

    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...... replacement is considered. We hypothesize that the time to hip replacement can be postponed in patients with severe hip osteoarthritis following participation in a patient education and supervised exercise program when compared to patients receiving patient education alone. Methods/design: A prospective...... will 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...

  13. 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

  14. Transfer of manualized Short Term Psychodynamic Psychotherapy (STPP for social phobia into clinical practice: study protocol for a cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Leweke Frank

    2011-06-01

    Full Text Available Abstract Background Psychodynamic psychotherapy is frequently applied in the treatment of social phobia. Nevertheless, there has been a lack of studies on the transfer of manualized treatments to routine psychodynamic practice. Our study is the first one to examine the effects of additional training in a manualized Short Term Psychodynamic Psychotherapy (STPP procedure on outcome in routine psychotherapy for social phobia. This study is an extension to a large multi-site RCT (N = 512 comparing the efficacy of STPP to Cognitive-Behavioral Therapy (CBT of Social Phobia. Methods/Design The manualized treatment is designed for a time limited approach with 25 individual sessions of STPP over 6 months. Private practitioners will be randomized to training in manualized STPP vs. treatment as usual without a specific training (control condition. We plan to enrol a total of 105 patients (84 completers. Assessments will be conducted before treatment starts, after 8 and 15 weeks, after 25 treatment sessions, at the end of treatment, 6 months and 12 months after termination of treatment. The primary outcome measure is the Liebowitz Social Anxiety Scale. Remission from social phobia is defined scoring with 30 or less points on this scale. Discussion We will investigate how the treatment can be transferred from a controlled trial into the less structured setting of routine clinical care. This question represents Phase IV of psychotherapy research. It combines the benefits of randomized controlled and naturalistic research. The study is genuinely designed to promote faster and more widespread dissemination of effective interventions. It will answer the questions whether manualized STPP can be implemented into routine outpatient care, whether the new methods improve treatment courses and outcomes and whether treatment effects reached in routine psychotherapeutic treatments are comparable to those of the controlled, strictly manualized treatment of the main study

  15. 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.

  16. 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...

  17. 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.

  18. A randomised clinical trial of comprehensive cardiac rehabilitation versus usual care for patients treated for infective endocarditis—the CopenHeartIE trial protocol

    Science.gov (United States)

    Rasmussen, Trine Bernholdt; Zwisler, Ann-Dorthe; Sibilitz, Kirstine Lærum; Risom, Signe Stelling; Bundgaard, Henning; Gluud, Christian; Moons, Philip; Winkel, Per; Thygesen, Lau Caspar; Hansen, Jane Lindschou; Norekvål, Tone Merete; Berg, Selina Kikkenborg

    2012-01-01

    Introduction Infective endocarditis (IE) is among the most serious infectious diseases in the western world. Treatment requires lengthy hospitalisation, high-dosage antibiotic therapy and possible valve replacement surgery. Despite advances in treatment, the 1-year mortality remains at 20–40%. Studies indicate that patients experience persisting physical symptoms, diminished quality of life and difficulties returning to work up to a year postdischarge. No studies investigating the effects of rehabilitation have been published. We present the rationale and design of the CopenHeartIE trial, which investigates the effect of comprehensive cardiac rehabilitation versus usual care for patients treated for IE. Methods and analysis We will conduct a randomised clinical trial to investigate the effects of comprehensive cardiac rehabilitation versus usual care on the physical and psychosocial functioning of patients treated for IE. The trial is a multicentre, parallel design trial with 1 : 1 individual randomisation to either the intervention or control group. The intervention consists of five psychoeducational consultations provided by specialised nurses and a 12-week exercise training programme. The primary outcome is mental health (MH) measured by the standardised Short Form 36 (SF-36). The secondary outcome is peak oxygen uptake measured by the bicycle ergospirometry test. Furthermore, a number of exploratory analyses will be performed. Based on sample size calculation, 150 patients treated for left-sided (native or prosthetic valve) or cardiac device endocarditis will be included in the trial. A qualitative and a survey-based complementary study will be undertaken, to investigate postdischarge experiences of the patients. A qualitative postintervention study will explore rehabilitation participation experiences. Ethics and dissemination The study complies with the Declaration of Helsinki and was approved by the regional research ethics committee (no H-1

  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. Toxoplasmose na gestação: diagnóstico, tratamento e importância de protocolo clínico Toxoplasmosis in pregnancy: diagnosis, treatment and the importance of clinical protocol

    Directory of Open Access Journals (Sweden)

    Fabiana Burdini Margonato

    2007-12-01

    Full Text Available OBJETIVOS: comparar aspectos laboratoriais, terapêuticos e gastos com toxoplasmose em gestantes, em época prévia à implantação de protocolo clínico, a uma situação hipotética de aplicação de um protocolo. MÉTODOS: coorte histórica com gestantes inscritas no pré-natal de unidades básicas de saúde de Londrina, Paraná, que realizaram exames laboratoriais de rotina de pré-natal, incluindo sorologia para toxoplasmose aguda, no período de janeiro a novembro de 2004. Os dados foram obtidos na Secretaria Municipal de Saúde e no Hospital Universitário. A realização de exame confirmatório, tratamento e respectivos gastos foram comparados com dados provenientes de uma situação hipotética de implantação de um protocolo clínico. RESULTADOS: na situação real, em 75% das gestantes com IgM reagente para toxoplasmose não houve diagnóstico definitivo e, entre as que realizaram exame confirmatório, o tempo médio decorrido entre os dois exames foi de 23 semanas; 28,5% foram tratadas sem confirmação e no único caso confirmado não houve tratamento. Na comparação com a situação hipotética, a realização do exame confirmatório na mesma amostra de sangue possibilitaria diagnóstico definitivo a todas. Os menores gastos com medicamentos compensariam o aumento de custos com exames confirmatórios. CONCLUSÕES: os resultados demonstram a importância da implantação de protocolos clínicos de forma adequada, quer seja sob o ponto de vista de proteção à saúde, ou de economia.OBJECTIVES: to compare therapeutic and laboratory aspects of toxoplasmosis in pregnant women as well as its cost in a real situation and in a hypothetical situation employing a clinical protocol.METHODS: a time-series cohort study was carried out with pregnant women taking part between January and November 2004 in the prenatal program at the Primary Health Units in Londrina, Paraná, Brazil, whose prenatal routine laboratory tests included serology

  1. 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

  2. Sleeve gastrectomy versus Roux-en-Y gastric bypass for type 2 diabetes and morbid obesity: double-blind randomised clinical trial protocol

    Science.gov (United States)

    Murphy, Rinki; Evennett, Nicholas J; Clarke, Michael G; Robinson, Steven J; Humphreys, Lee; Jones, Bronwen; Kim, David D; Cutfield, Richard; Plank, Lindsay D; Hammodat, Hisham; Booth, Michael W C

    2016-01-01

    Introduction Type 2 diabetes (T2D) in association with obesity is an increasing disease burden. Bariatric surgery is the only effective therapy for achieving remission of T2D among those with morbid obesity. It is unclear which of the two most commonly performed types of bariatric surgery, laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB), is most effective for obese patients with T2D. The primary objective of this study is to determine whether LSG or LRYGB is more effective in achieving HbA1c<6% (<42 mmol/mol) without the use of diabetes medication at 5 years. Methods and analysis Single-centre, double-blind (assessor and patient), parallel, randomised clinical trial (RCT) conducted in New Zealand, targeting 106 patients. Eligibility criteria include age 20–55 years, T2D of at least 6 months duration and body mass index 35–65 kg/m2 for at least 5 years. Randomisation 1:1 to LSG or LRYGB, used random number codes disclosed to the operating surgeon after induction of anaesthesia. A standard medication adjustment schedule will be used during postoperative metabolic assessments. Secondary outcomes include proportions achieving HbA1c<5.7% (39 mmol/mol) or HbA1c<6.5% (48 mmol/mol) without the use of diabetes medication, comparative weight loss, obesity-related comorbidity, operative complications, revision rate, mortality, quality of life, anxiety and depression scores. Exploratory outcomes include changes in satiety, gut hormone and gut microbiota to gain underlying mechanistic insights into T2D remission. Ethics and dissemination Ethics approval was obtained from the New Zealand regional ethics committee (NZ93405) who also provided independent safety monitoring of the trial. Study commenced in September 2011. Recruitment completed in October 2014. Data collection is ongoing. Results will be reported in manuscripts submitted to peer-reviewed journals and in presentations at national and international meetings

  3. Transport Protocol Throughput Fairness

    Directory of Open Access Journals (Sweden)

    Saleem Bhatti

    2009-11-01

    Full Text Available Interest continues to grow in alternative transport protocols to the Transmission Control Protocol (TCP. These alternatives include protocols designed to give greater efficiency in high-speed, high-delay environments (so-called high-speed TCP variants, and protocols that provide congestion control without reliability. For the former category, along with the deployed base of ‘vanilla’ TCP – TCP NewReno – the TCP variants BIC and CUBIC are widely used within Linux: for the latter category, the Datagram Congestion Control Protocol (DCCP is currently on the IETF Standards Track. It is clear that future traffic patterns will consist of a mix of flows from these protocols (and others. So, it is important for users and network operators to be aware of the impact that these protocols may have on users. We show the measurement of fairness in throughput performance of DCCP Congestion Control ID 2 (CCID2 relative to TCP NewReno, and variants Binary Increase Congestion control (BIC, CUBIC and Compound, all in “out-of-the box” configurations. We use a testbed and endto- end measurements to assess overall throughput, and also to assess fairness – how well these protocols might respond to each other when operating over the same end-to-end network path. We find that, in our testbed, DCCP CCID2 shows good fairness with NewReno, while BIC, CUBIC and Compound show unfairness above round-trip times of 25ms.

  4. Linear Logical Voting Protocols

    DEFF Research Database (Denmark)

    DeYoung, Henry; Schürmann, Carsten

    2012-01-01

    . 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...

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. 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

  13. 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

  14. 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

  15. 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.

  16. 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.

  17. Clinical characteristics of 26 children with Burkitt’s leukemia and outcome of treatment with revised LMB 89 protocol%儿童伯基特白血病26例临床研究

    Institute of Scientific and Technical Information of China (English)

    段彦龙; 金玲; 杨菁; 黄爽; 张梦; 赖瑞; 周春菊; 张永红

    2016-01-01

    Objective To summarize the clinical features and to evaluate outcomes and to assess therapeutic effects in 26 children and adolescents with Burkitt’s leukemia treated with revised LMB 89 protocol in China. Methods From January 2010 to April 2015, 26 hospitalized children and adolescents with Burkitt’s leukemia were enrolled into this study. Staging was based on clinical evaluation and was defined by the St. Jude staging system. All patients were confirmed to have Burkitt’s leukemia and mature B blast >25% in marrow that diagnosed by MICM system and biopsy of marrow. The 26 patients were treated with C group of the revised LMB 89 protocol . All analyses were performed by the statistical program SPSS. Results Of the 26 Burkitt’s leukemia patients, 24 were male and 2 were female. The median age was 7. 8 years ( range from 3 years to 13 years) at the time of diagnosis. In terms of clinical presentation,88% had abdominal bulky lymphoma involvement;in 62% of the patients maxillofacial region was involved, 27% had testis involvement, 69% had severe tumor lysis syndrome. All patients were followed up. The overall survival ( OS) and the 2-year event-free survival was 76. 9%respectively at a median follow-up of 35 months. All patients suffered from IV degree marrow suppression and sever infection. Two patients died from sepsis in the early 2 course of chemotherapy because of severe marrow suppression, and no child died from TLS. Three patients had early relapse after treatment was finished. Conclusion Childhood Burkitt’s leukemia in our study was more frequently seen in male school aged children. Revised LMB 89 protocol used for Burkitt’s leukemia is effective and well tolerated if the early TLS could be controlled. The overall prognosis is worse than that of other group Burkitt’s lymphoma because of early severe persistent marrow suppression complicated with sepsis. The early relapse is still a challenge.%目的:认识儿童伯基特白血病

  18. Gestión clínica en un servicio de angiología y cirugía vascular: Resultados de la aplicación de algoritmos de manejo clínico Clinical management in a vascular surgery unit: Results of the application of a clinical practice protocol

    Directory of Open Access Journals (Sweden)

    J. Juliá

    2003-10-01

    Full Text Available Objetivo: Analizar el impacto de la gestión clínica en los indicadores básicos de calidad en un servicio de cirugía vascular durante un período de 10 años. Métodos: Análisis retrospectivo de los indicadores asistenciales en el período 1990-2001 y la influencia que han tenido una guía de manejo clínico y la elaboración de unos estándares de calidad. Resultados: Los indicadores de calidad analizados mejoran al comparar ambos períodos. El nivel de seguridad asistencial medicoquirúrgico no se afectó por la aplicación de algoritmos de manejo y de guías de cuidados clínicos. Conclusiones: La gestión clínica basada en el binomio coste-calidad puede asegurar la eficiencia de un servicio y optimizar los recursos sin menoscabo de la calidad de los procedimientos asistenciales. Es posible definir el estándar de calidad por grupo de procedimientos, en función de la utilización de recursos hospitalarios y de las tasas de morbimortalidad.Objectives: The aim of this study was to analyze the impact of clinical management on quality indicators in a vascular surgery unit over a 10-year period. Methods: We performed a retrospective analysis of quality indicators from 1990 to 2001 and of the influence of a clinical practice protocol and standards of quality on these indicators. Results: Comparison of both periods revealed improvement in all the quality indicators. The safety of surgical procedures was unaffected by the application of management protocols and clinical pathways. Conclusions: Clinical management based on the cost-quality binomial can ensure the efficiency of a hospital unit without adversely affecting quality of care. Quality standards based on hospital resource use, morbidity and mortality can be defined for groups of procedures.

  19. Cytoskeleton - Methods and Protocols

    Directory of Open Access Journals (Sweden)

    CarloAlberto Redi

    2010-03-01

    Full Text Available Cytoskeleton - Methods and ProtocolsSecond edition, 2010; Ray H. Gavin (Ed; Springer Protocols methods in molecular biology, vol. 586 Humana press, Totowa, New Jersey (USA; Pages: 390; €95.44; ISBN: 978-1-60761-375-6Ray H. Gavin, from the Brooklyn College of The City University of New York, Brooklyn, NY, USA, wrote a few line as preface of this book. This is quite understandable: there is not a great need of words when there are facts that sustain and favour the dissemination of a cultural product. This is the case of the second edition of Cytoskeleton - Methods and Protocols, which appears just ten years after the first edition...

  20. 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...

  1. 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...... (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...

  2. Apoptosis - Methods and Protocols

    Directory of Open Access Journals (Sweden)

    CarloAlberto Redi

    2010-03-01

    Full Text Available Apoptosis - Methods and ProtocolsSecond edition, 2009; Peter Erhardt and Ambrus Toth (Eds; Springer Protocols - Methods in molecular biology, vol. 559; Humana press, Totowa, New Jersey (USA; Pages: 400; €88.35; ISBN: 978-1-60327-016-8The editors rightly begin the preface telling us that: “The ability to detect and quantify apoptosis, to understand its biochemistry and to identify its regulatory genes and proteins is crucial to biomedical research”. Nowadays this is a grounding concept of biology and medicine. What is particularly remarkable...

  3. 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...

  4. 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...

  5. Clinical outcomes of modified long protocol used in patients who failed in first cycle with antagonist protocol%改良长方案在初次拮抗剂方案助孕治疗失败患者中的应用

    Institute of Scientific and Technical Information of China (English)

    胡玉琴; 蔡嘉力; 刘兰兰; 沙爱国; 任建枝; 李萍

    2014-01-01

    Objective:To compare IVF outcomes with modified long protocol and an-tagonist protocol in women who failed in their first IVF attempt with antagonist protocol. Meth-ods:A total of 169 patients failed in first cycle with antagonist protocol who underwent the sec-ondary cycles were retrospectively analyzed. Patients were divided into two groups:the study group included 130 patients receiving modified long protocol and the control group included 39 patients receiving flexible antagonist protocol. Results:There was no significant difference in general characteristics between the two groups(P>0. 05). E2 level on HCG injection day,Gn duration and dosage in study group were higher than those in control group. The LH level on HCG injection day was significantly lower than the control group ( P0.05)。研究组的注射HCG日E2值、Gn用药时间和Gn剂量均显著高于对照组(P<0.05),注射HCG日LH值显著低于对照组(P<0.05)。研究组的临床妊娠率、种植率及活产率分别为55.2%、36.4%和46.4%,均显著高于对照组(27.3%、22.0%和21.2%)(P<0.05)。结论:初次拮抗剂方案失败行再次助孕治疗的患者中,改良长方案可能通过改善子宫内膜的容受性,获得了较拮抗剂方案更好的妊娠结局。

  6. 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

  7. 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.

  8. 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.

  9. 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.)

  10. 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)

  11. 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.

  12. 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)

  13. 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

  14. 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.

  15. Mitosis Methods & Protocols

    Directory of Open Access Journals (Sweden)

    CarloAlberto Redi

    2010-06-01

    Full Text Available Mitosis Methods & Protocols Andrew D. McAinsh (Edt Humana press, Totowa, New Jersey (USA Series: Springer Protocols Methods in Molecular Biology, Volume 545, 2009 ISBN: 978-1-60327-992-5   It is quite clear from the contents of this book that the remarkably fascinating phenomenon of mitosis (that captured, and still is capturing, the attention of entire generations of scientists is still open to research. This is mainly due to our lack of knowledge of so many multifaced events of this extraordinarly complex process. The reader giving a glace through the Contents and Contributors sections is speechless: All of the first-class models (i.e., budding yeast, Caenorabditis, Drosophila, Xenopus and Human are presented..... 

  16. 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

  17. Automatic Validation of Protocol Narration

    DEFF Research Database (Denmark)

    Bodei, Chiara; Buchholtz, Mikael; Degano, Pierpablo;

    2003-01-01

    We perform a systematic expansion of protocol narrations into terms of a process algebra in order to make precise some of the detailed 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 for identifying a number of authentication flaws in symmetric key protocols such as Needham-Schroeder, Otway-Rees, Yahalom and Andrew Secure RPC....

  18. 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...

  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. Static Validation of Security Protocols

    DEFF Research Database (Denmark)

    Bodei, Chiara; Buchholtz, Mikael; Degano, P.;

    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...

  1. Radiotherapy QA of the DAHANCA 19 protocol

    DEFF Research Database (Denmark)

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

    2015-01-01

    trials. RT-QA of large multicentre-trials, however, requires substantial effort and resources. Recently, we presented a digital QA platform, the CIRRO dose plan bank, which allows for central review of such trials. Here, we present our RT-QA results from the latest completed clinical protocol from...... 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...

  2. 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)

  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. 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.

  5. FRENCH PROTOCOL CARDS

    CERN Multimedia

    Division des Ressources Humaines; Human Resources Division; Tel. 74683-79494

    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.

  6. 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

  7. 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...

  8. 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

  9. 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.

  10. 糖皮质激素治疗多发性硬化不同方案的临床应用%Clinical application of different protocols of glucocorticoids on treating multiple sclerosis

    Institute of Scientific and Technical Information of China (English)

    董艳玲; 李吕力; 李瑶宣; 梁浩; 滕晓茗; 肖继东; 张德敏

    2012-01-01

    Objective To evaluate the curative effects, the expenses and time of hospitalization, the condition of recurrence and the adverse reactions of different protocols of glucocorticoids on treating multiple sclerosis (MS). Methods Ninty-seven MS patients at acute stage were randomly divided into melhylprednisolone (MPS) intrathecal injection group (30 cases) , MPS pulse therapy group (36 cases) and dexamethasone ( DXM ) therapy group (31 cases). The decrease of Kurtzke expanded disability status scale(EDSS) at different time after treatmentand, the expenses and time of hospitalization, the proportion of drugs in hospitalization expenses, the condition of recurrence and the adverse reactions among all the groups were compared with each other. Results The decrease of EDSS in MPS intrathecal injection group scince 5 d after treatment and in MPS pulse therapy group scince 10 d after treatment were significantly higher than that in DXM therapy group (all P<0. 05). The decrease of EDSS in MPS intrathecal injection group at 5 d after treatment was significantly higher than that in MPS pulse therapy group (P < 0.05). Among the three groups, the total expense of hospitalization and the proportion of drugs in hospitalization expenses were the least in MPS intrathecal injection group, and the daily mean expense of hospitalization was little, ihe hospitalization time was short (all P<0.05). The daily mean expense of hospitalization was the most in MPS pulse therapy group, and the hospitalization time was the longest in DXM therapy group (all P<0.05). The recurrence rate was the highest and the recurrence time was the shortest in MPS pulse therapy group (all P < 0. 05). The difference of recurrence rate and time was no statistical significance between MPS intrathecal injection group and DXM therapy group. There was no severe adverse reaction in all the groups. Conclusions The curative effect of MPS intrathecal injection on treating MS is fast and significant in short-term with

  11. 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.

  12. 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....

  13. 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...

  14. Unconditionally Secure Protocols

    DEFF Research Database (Denmark)

    Meldgaard, Sigurd Torkel

    they are used to speed up secure computation. An Oblivious RAM is a construction for a client with a small $O(1)$ internal memory to store $N$ pieces of data on a server while revealing nothing more than the size of the memory $N$, and the number of accesses. This specifically includes hiding the access pattern......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....... We construct an oblivious RAM that hides the client's access pattern with information theoretic security with an amortized $\\log^3 N$ query overhead. And how to employ a second server that is guaranteed not to conspire with the first to improve the overhead to $\\log^2 N$, while also avoiding...

  15. Treatment protocols for cervical cancer

    Directory of Open Access Journals (Sweden)

    Vujkov Tamara

    2002-01-01

    Full Text Available Introduction Cervical cancer is the second most common cancer in women worldwide and the second cause of cancer death among women. About 95% (90% in developed countries of invasive carcinomas are of sqamous types, and 5% (10% in developed countries are adenocarcinomas. FIGO classification of cervical carcinomas, based on clinical staging and prognostic factor dictate therapeutic procedures and help in designing treatment protocols. Therapeutic modalities Surgical therapy includes conization, radical hysterectomy with pelvic lymphadenectomy and palliative operation urinary diversion and colostomy. Radiotherapy, brachytherapy and teletherapy are most recently combined with chemotherapy as concurrent chemoradiation. Discussion and conclusion No change in therapeutic modalities will ever decrease mortality rate of cervical carcinoma as much as education, prevention and early screening. The 5-year survival for locally advanced disease has not improved during the last 40 years as a result of failure to deliver therapy to the paraaortic region. Paraaortic lymph nodes should be evaluated before therapy planning by different imaging procedures, or more exactly by surgical staging: laparoscopy or laparotomy. Radical operations of cervical carcinoma should be performed by experienced surgeons, educated for this type of operation, with sufficient number of cases.

  16. Gamma camera performance: technical assessment protocol

    Energy Technology Data Exchange (ETDEWEB)

    Bolster, A.A. [West Glasgow Hospitals NHS Trust, London (United Kingdom). Dept. of Clinical Physics; Waddington, W.A. [University College London Hospitals NHS Trust, London (United Kingdom). Inst. of Nuclear Medicine

    1996-12-31

    This protocol addresses the performance assessment of single and dual headed gamma cameras. No attempt is made to assess the performance of any associated computing systems. Evaluations are usually performed on a gamma camera commercially available within the United Kingdom and recently installed at a clinical site. In consultation with the manufacturer, GCAT selects the site and liaises with local staff to arrange a mutually convenient time for assessment. The manufacturer is encouraged to have a representative present during the evaluation. Three to four days are typically required for the evaluation team to perform the necessary measurements. When access time is limited, the team will modify the protocol to test the camera as thoroughly as possible. Data are acquired on the camera`s computer system and are subsequently transferred to the independent GCAT computer system for analysis. This transfer from site computer to the independent system is effected via a hardware interface and Interfile data transfer. (author).

  17. 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 ...

  18. Protocols for Robotic Telescope Networks

    Directory of Open Access Journals (Sweden)

    Alain Klotz

    2010-01-01

    This paper is addressed to astronomers who are not specialists in computer science. We give explanations of some basic and advanced protocols to receive events and how to implement them in a robotic observatory software. We describe messages such as GCN notices, VOEvents or RTML, and protocols such as CGI, HTTP, SOAP, RSS, and XMPP.

  19. 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.)

  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. 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

  2. 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

  3. 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.

  4. 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

  5. Drug-usage evaluation by disease state: developing protocols.

    Science.gov (United States)

    Enlow, M L

    1996-07-01

    The Joint Commission definition of drug-usage evaluation (DUE) also applies to DUE by disease state. The criteria for disease process selection, key processes being evaluated, methods to develop initial DUE protocols, and DUE validation and approval processes are reviewed. The treatment of community-acquired pneumonia is a disease state DUE performed at Saint Joseph Health Center in Kansas City, Missouri. The preliminary protocol was developed by a collaborative network of clinical pharmacists in the metropolitan area. Outcome measures were included in the evaluation. The results were used as baseline data in the development of a pneumonia clinical pathway.

  6. 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.

  7. 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.

  8. 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

  9. 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.)

  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. 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...

  12. 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

  13. SIP protocol model for OMNET++

    Directory of Open Access Journals (Sweden)

    Jan Kucerak

    2016-01-01

    Full Text Available The article describes our new SIP protocol implementation for the OMNeT++ simulation framework. OMNeT++ simulation framework provides an extensive support of IP related protocols, nevertheless a working SIP protocol implementation is missing. Real measurements were also done using a SIPp traffic generator and the results are compared to those obtained by our new SIP model. Since this work is a part of bigger project concerned strictly on measuring "first response times" over networks with a faulty transmission links, the actually collected statistics are focused only this way.

  14. 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).

    NARCIS (Netherlands)

    Boveldt, N.D. te; Engels, Y.M.P.; Besse, K.; Vissers, K.C.P.; Vernooij-Dassen, M.J.F.J.

    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

  15. 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...

  16. Dynamic random channel reservation protocol

    Institute of Scientific and Technical Information of China (English)

    Ren Yanying; Zhang Wenjun; Yu Songyu

    2005-01-01

    Demand assignment MAC protocols have been used widely in wireless networks. It can effectively utilize wireless bandwidth. Some strategies can be used by demand assignment MAC protocols to further improve their efficiency. The concept of transmit probability is introduced. This concept allows a request slot to be assigned to many different traffic classes at the same time. Based on it, the dynamic random channel reservation (DRCR) protocol is proposed. The DRCR protocol operates dynamically by observing the traffic conditions. It uses information about the recent traffic conditions to assign transmit probability with which an mobile station can select request slots with lower traffic. The performance of DRCR is evaluated and compared with RSCA. The results show that DRCR is more stable than RSCA, it offers shorter delays of requests than RSCA and can relieve heavily stressed traffic classes faster than RSCA.

  17. National Elk Refuge vaccination protocol

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — Proposal by the State of Wyoming, Wyoming Game and Fish Department, to vaccinate elk on the National Elk Refuge. The proposal provides a protocol for vaccinating...

  18. 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.

  19. 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.

  20. 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.

  1. Self-Healing Protocol Implementations

    OpenAIRE

    Tschudin, Christian; Yamamoto, Lidia

    2005-01-01

    Current studies on self-configuring and adaptive networks aim at developing specific and fixed protocols which are able to optimize their configuration in a variable network environment. In this talk we study the problem where the protocols need to cope with a defective execution, including the lossy execution or the injection of foreign code. One guiding question will be the creation of robust execution circuits which can distribute over a network and which continue their service despite par...

  2. 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)

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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.

  9. 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

  10. Optimizing prostate cancer detection: 8 versus 12-core biopsy protocol

    NARCIS (Netherlands)

    J.J.M.C.H. de la Rosette; M.H. Wink; C. Mamoulakis; N. Wondergem; F.J.C. ten Kate; K. Zwinderman; Th.M. de Reijke; H. Wijkstra

    2009-01-01

    PURPOSE: We compared prostate cancer detection rates achieved using an 8 and 12-core biopsy protocol in a clinical population to determine the significance of additional transition zone sampling on repeat biopsy. MATERIALS AND METHODS: Between September 2004 and September 2007, 269 eligible patients

  11. 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)

  12. Validation of NINDS-VCI Neuropsychology Protocols for Vascular Cognitive Impairment in Taiwan.

    Directory of Open Access Journals (Sweden)

    Hsiu-Fen Lin

    Full Text Available To validate the three time-difference neuropsychological protocols developed by the National Institute of Health/National Institute of Neurological Disorders and Stroke (NINDS and the Canadian Stroke Network for assessment of vascular cognitive impairment (VCI in Mandarin-speaking subjects and to investigate the clinical application of the shortest form.Patients aged 50 years or older who had a stroke were invited to participate in the study. Clinical diagnosis of VCI was made. The NINDS-VCI Neuropsychology Protocols, 60-, 30-, and two 5-minute protocols, were administered. The criteria validities of the cognitive protocols against the diagnoses of stroke and VCI were determined via Receiver Operating Characteristic (ROC analysis. The optimal cut-off point for the 5-minute protocols total score was estimated for clinical use in screening.Eighty-three patients and 53 controls were recruited during the study period. Patients with stroke performed more poorly than the control group in the three neuropsychological protocols. Forty-two patients with stroke were diagnosed with VCI. VCI was used as the standard to estimate the criteria validities. The area under the ROC curve was 0.78, 0.80, 0.75, and 0.73 for the 60-, 30-, 5-mintue protocol-A and 5-minute protocol-B, respectively.These modified neuropsychological protocols can be used as valid instruments when performing comprehensive cognitive assessment or for screening of VCI in Taiwan.

  13. 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

  14. 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

  15. 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

  16. 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

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

    Science.gov (United States)

    Stoliartchouk, Alexei; Kindler, Lori; Hurwitz, Bonnie L.

    2016-01-01

    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

  18. 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

  19. 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

  20. 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

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

    Directory of Open Access Journals (Sweden)

    A Ghodousi

    2012-03-01

    Full Text Available 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.

  2. Adherence to guidelines and protocols in the prehospital and emergency care setting: a systematic review

    NARCIS (Netherlands)

    Ebben, R.H.A.; Vloet, L.C.M.; Verhofstad, M.H.J.; Meijer, S.; Groot, J. de; Achterberg, T. van

    2013-01-01

    A gap between guidelines or protocols and clinical practice often exists, which may result in patients not receiving appropriate care. Therefore, the objectives of this systematic review were (1) to give an overview of professionals' adherence to (inter)national guidelines and protocols in the emerg

  3. Adherence to guidelines and protocols in the prehospital and emergency department setting : A systematic review

    NARCIS (Netherlands)

    Achterberg, Theo van; Mintjes, Joke; Verhofstad, M.; Meijer, S.; Vloet, Lilian

    2011-01-01

    A gap between guidelines or protocols and clinical practice often exists, which may result in patients not receiving appropriate care. Therefore, the objectives of this systematic review were (1) to give an overview of professionals’ adherence to (inter)national guidelines and protocols in the emerg

  4. Field validation of protocols developed to evaluate in-line mastitis detection systems

    NARCIS (Netherlands)

    Kamphuis, C.; Dela Rue, B.T.; Eastwood, C.R.

    2016-01-01

    This paper reports on a field validation of previously developed protocols for evaluating the performance of in-line mastitis-detection systems. The protocols outlined 2 requirements of these systems: (1) to detect cows with clinical mastitis (CM) promptly and accurately to enable timely and appr

  5. 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

  6. 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

  7. [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

    Energy Technology Data Exchange (ETDEWEB)

    DeNardo, S.J.

    1995-12-31

    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 {sup 90}Y quantitation with Bremsstrahlung imaging. The study on SPECT discusses attenuation correction and scatter correction. Preclinical studies investigated uptake of {sup 90}Y-BrE-3 in mice using autoradiography. Clinical studies discuss image quantitation verses counts from biopsy samples, S factors for radiation dose calculation, {sup 67}Cu imaging studies for lymphoma cancer, and {sup 111}In MoAb imaging studies for breast cancer to predict {sup 90}Y MoAb therapy.

  8. 全胚玻璃化冷冻在微刺激方案中的临床应用%The clinical application effect of whole embryo vitrification freezing for mild ovarian stimulation protocol

    Institute of Scientific and Technical Information of China (English)

    张文权; 黄开淑; 唐玢; 许微

    2013-01-01

    目的 探讨全胚玻璃化冷冻在微刺激方案中的临床应用价值.方法 选择微刺激方案ⅣF全胚冷冻后首次行冻胚移植116个周期为观察组;选择同期微刺激方案ⅣF鲜胚移植周期132个为对照组.对两组患者超促排卵(COH)情况、获卵数、人绒毛膜促性腺激素(HCG)日雌二醇(E2)水平、移植日内膜厚度、受精率、卵裂率、优胚率、移植胚胎数、临床妊娠率、种植率、流产率等情况进行比较.结果 观察组HCG日E2水平、获卵数明显低于对照组(P<0.01).但临床妊娠率、种植率明显高于对照组(P<0.01);两组患者的超促排卵(COH)情况、移植日内膜厚度、受精率、卵裂率、优胚率、移植胚胎数、流产率差异无统计学意义(P>0.05).结论 微刺激方案行全胚玻璃化冷冻可明显提高临床妊娠率.%Objective:To explore the clinical application effect of whole embryo vitrification freezing for in vitro fertilization and embryo transfer (IVF-ET) with mild ovarian stimulation.Methods:116 cycles of whole embryo vitrification freezing for IVF-ET with mild ovarian stimulation and the first time thawed frozen embryo transplantation were studied,The total dose of gonadotropin and the number of retrieved oocytes,estradiol levels on HCG day,endometrial thickness on ET day,the normal fertilization rate,cleavage rate,high quality embryo rate,clinical pregnancy rate,implantation rate and abortion rate were compared with 132 fresh cycles on the same term.Results:The number of retrieved oocytes,estradiol levels on HCG day,clinical pregnancy rate,and implantation had significant different between two groups (P < 0.01).There was no significantly different endometrial thickness on ET day,fertilization rate,cleavage rate,high quality embryo rate,number of ET embryo and abortion rate (P > 0.05).Conclusion:Using whole embryo vitrification freezing can gain good clinical effect for IVF-ET with mild ovarian stimulation.

  9. 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

  10. 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

  11. 口服避孕药预处理对长效长方案体外受精-胚胎移植临床结局的影响%The effect of oral contraceptive pill pretreatment on clinical outcome in patients with long - acting form of gonadotrophin releasing - hormone agonist long protocol

    Institute of Scientific and Technical Information of China (English)

    董哲; 孙玲; 尹敏娜

    2016-01-01

    目的:探讨口服避孕药( oral contraception pill,OCP)前期预处理对接受长效长方案控制性超排卵患者临床结局的影响。方法对2011年1月至2013年4月在广州市妇女儿童医疗中心生殖医学中心进行长效长方案治疗的正常卵巢储备患者325例的临床资料进行分析。采用OCP前期预处理的185例患者为OCP 组,未采用 OCP 预处理140例患者为对照组。比较两组卵巢过度刺激综合征( ovarian hyperstimulation syndrome,OHSS)发生率、促性腺激素用量与天数、获卵数、临床妊娠率、着床率。结果 OCP组OHSS发生率(5.9%)高于对照组(1.4%)(P0.05)。结论长效长方案治疗中,OCP预处理可能增加了正常卵巢储备患者OHSS的发生率。%Objective To evaluate the effects of oral contraception pill ( OCP) pretreatment on clinical outcome of patients with long-acting form of gonadotrophin releasing -hormone agonist ( GnRH -a ) long protocol. Methods The clinical data of 325 patients undergone in-vitro fertilization ( IVF) in Reproductive Medicine Center of Guangzhou Women and Children’ s Medical Center from January 2011 to April 2013 were analyzed retrospectively. Among them,185 patients treated with OCP ( Marvelon) were set as OCP group,and 140 patients received gonadotropin-releasing hormone agonist( GnRH-a) down regulation after spontaneous ovulation were set as control group. Occurrence rate of ovarian hyperstimulation syndrome (OHSS), the duration and amount of gonadotropin used, number of retrieved oocytes, clinical pregnancy rate and implantation rate of two groups were compared. Results The incidence rate of OHSS in OCP group was higher than that in control group(P0. 05). ConclusionsPretreatment with an OCP could increase the incidence of OHSS in patients with normal ovarian reserve who accepted long-acting form of GnRH-a long protocol.

  12. Cryptographic Protocols under Quantum Attacks

    CERN Document Server

    Lunemann, Carolin

    2011-01-01

    The realm of this thesis is cryptographic protocol theory in the quantum world. We study the security of quantum and classical protocols against adversaries that are assumed to exploit quantum effects to their advantage. Security in the quantum world means that quantum computation does not jeopardize the assumption, underlying the protocol construction. But moreover, we encounter additional setbacks in the security proofs, which are mostly due to the fact that some well-known classical proof techniques are forbidden by certain properties of a quantum environment. Interestingly, we can exploit some of the very same properties to the benefit of quantum cryptography. Thus, this work lies right at the heart of the conflict between highly potential effects but likewise rather demanding conditions in the quantum world.

  13. Superposition Attacks on Cryptographic Protocols

    DEFF Research Database (Denmark)

    Damgård, Ivan Bjerre; Funder, Jakob Løvstad; Nielsen, Jesper Buus;

    2011-01-01

    Attacks on classical cryptographic protocols are usually modeled by allowing an adversary to ask queries from an oracle. Security is then defined by requiring that as long as the queries satisfy some constraint, there is some problem the adversary cannot solve, such as compute a certain piece...... 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...... of 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...

  14. Symbolic Analysis of Cryptographic Protocols

    DEFF Research Database (Denmark)

    Dahl, Morten

    a 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...... Compos- able framework by Canetti for specifying and analysing protocols, and show that our model is sound with respect to its standard computational interpretation. Our model supports powerful primitives such as homomorphic encryption and non-interactive zero-knowledge proofs, which we show may be used...... to implement several interesting two-party functionalities. As a case study we use the ProVerif tool to analyse an oblivious transfer protocol by Damgard et al. under static corruption...

  15. Lightweight Distance Bounding Protocol against Relay Attacks

    Science.gov (United States)

    Kim, Jin Seok; Cho, Kookrae; Yum, Dae Hyun; Hong, Sung Je; Lee, Pil Joong

    Traditional authentication protocols are based on cryptographic techniques to achieve identity verification. Distance bounding protocols are an enhanced type of authentication protocol built upon both signal traversal time measurement and cryptographic techniques to accomplish distance verification as well as identity verification. A distance bounding protocol is usually designed to defend against the relay attack and the distance fraud attack. As there are applications to which the distance fraud attack is not a serious threat, we propose a streamlined distance bounding protocol that focuses on the relay attack. The proposed protocol is more efficient than previous protocols and has a low false acceptance rate under the relay attack.

  16. Aspectos ultrassonográficos associados à morbidade de formas clínicas crônicas de esquistossomose mansônica, utilizando-se protocolo proposto pela Organização Mundial da Saúde Sonographic features associated with morbidity of chronic clinical presentations of schistosomiasis mansoni using the protocol proposed by the World Health Organization

    Directory of Open Access Journals (Sweden)

    Daniel Alvarenga Fernandes

    2013-02-01

    Full Text Available OBJETIVO: Avaliar aspectos ultrassonográficos associados à morbidade em pacientes com formas clínicas crônicas de esquistossomose mansônica, utilizando-se protocolo proposto pela Organização Mundial da Saúde (OMS. MATERIAIS E MÉTODOS: Foram avaliadas duas populações distintas: a área endêmica e b institucional terciária, com histopatológico confirmando fibrose. Critérios de inclusão: diagnóstico confirmado por parasitológico de fezes para Schistosoma mansoni (método Kato-Katz. Critérios de exclusão: sorologia positiva para HIV, HTLV-1, VHB ou VHC. Foi utilizado protocolo ultrassonográfico de Niamey, proposto pela OMS. RESULTADOS: Avaliando-se isoladamente as medidas dos espaços periportais, estas se mostraram sem alterações em 21% dos indivíduos com doença avançada da instituição terciária. Utilizando-se todos os parâmetros do protocolo, 100% dos indivíduos da instituição terciária, com forma grave da doença, apresentaram fibrose periportal avançada. Em pacientes hepatoesplênicos da área endêmica não se identificou fibrose à ultrassonografia. CONCLUSÃO: O protocolo ultrassonográfico proposto pela OMS detecta fibrose periportal avançada nos pacientes com forma grave da doença, com maior sensibilidade do que a medida do espaço periportal isoladamente. A complexidade de identificação das fases iniciais da fibrose periportal, em áreas endêmicas, pela ultrassonografia, pode suscitar o campo da complementação diagnóstica e a continuidade do aprimoramento dos protocolos ultrassonográficos nestas áreas.OBJECTIVE: To evaluate sonographic features associated with morbidity in patients with chronic clinical presentations of schistosomiasis mansoni, according to the protocol proposed by the World Health Organization (WHO. MATERIALS AND METHODS: Two distinctive populations were evaluated: a patients from an endemic area, and b patients from a tertiary institution, with histopathologically confirmed

  17. 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.

  18. 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.)

  19. 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

  20. 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...

  1. 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...

  2. Developing security protocols in χ-Spaces

    DEFF Research Database (Denmark)

    Crazzolara, Federico; Milicia, Giuseppe

    2002-01-01

    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 effo......-Spaces aids several steps in the development of a security protocolprotocol executions can be simulated in hostile environments, a security protocol can be implemented, and security properties of implementations can be formally verified....

  3. 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

  4. 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

  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. 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

  7. 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.

  8. A quantitative comparison of two kinematic protocols for lumbar segment motion during gait.

    Science.gov (United States)

    Kiernan, D; Malone, A; O'Brien, T; Simms, C K

    2015-02-01

    During gait analysis, motion of the lumbar region is tracked either by means of a 2-dimensional assessment with markers placed along the spine or a 3-dimensional assessment treating the lumbar region as a rigid segment. The rigid segment assumption is necessary for inverse dynamic calculations further up the kinematic chain. In the absence of a reference standard, the choice of model is mostly based on clinical experience. However, the potential exists for large differences in kinematic output if different protocols are used. The aim of this study was to determine the influence of using two 3-dimensional lumbar segment protocols on the resultant kinematic output during gait. The first protocol was a skin surface rigid protocol with markers placed across the lumbar region while the second consisted of a rigid cluster utilizing active markers applied over the 3rd lumbar vertebra. Data from both protocols were compared through simultaneous recording during gait. Overall variability was lower in 4 out of 6 measures for the skin surface protocol. Ensemble average graphs demonstrated similar mean profiles between protocols. However, Functional Limits of Agreement demonstrated only a poor to moderate agreement. This trend was confirmed with a poor to moderate waveform similarity (CMC range 0.29-0.71). This study demonstrates that the protocol used to track lumbar segment kinematics is an important consideration for clinical and research purposes. Greater variability recorded by the rigid cluster during lumbar rotation suggests the skin surface protocol may be more suited to studies where axial rotation is a consideration.

  9. 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

  10. The CHICO (Children's Cough) Trial protocol: a feasibility randomised controlled trial investigating the clinical and cost-effectiveness of a complex intervention to improve the management of children presenting to primary care with acute respiratory tract infection

    Science.gov (United States)

    Turnbull, Sophie L; Redmond, Niamh M; Lucas, Patricia; Cabral, Christie; Ingram, Jenny; Hollinghurst, Sandra; Hay, Alastair D; Peters, Tim J; Horwood, Jeremy; Little, Paul; Francis, Nick; Blair, Peter S

    2015-01-01

    Introduction While most respiratory tract infections (RTIs) will resolve without treatment, many children will receive antibiotics and some will develop severe symptoms requiring hospitalisation. There have been calls for evidence to reduce uncertainty regarding the identification of children who will and will not benefit from antibiotics. The aim of this feasibility trial is to test recruitment and the acceptance of a complex behavioural intervention designed to reduce antibiotic prescribing, and to inform how best to conduct a larger trial. Methods and analysis The CHICO (Children's Cough) trial is a single-centre feasibility cluster randomised controlled trial (RCT) comparing a web-based, within-consultation, behavioural intervention with usual care for children presenting to general practitioner practices with RTI and acute cough. The trial aims to recruit at least 300 children between October 2014 and April 2015, in a single area in South West England. Following informed consent, demographic information will be recorded, and symptoms and signs measured. Parents/carers of recruited children will be followed up on a weekly basis to establish symptom duration, resource use and cost of the illness to the parent until the child's cough has resolved or up to 8 weeks, whichever occurs earlier. A review of medical notes, including clinical history, primary care reconsultations and hospitalisations will be undertaken 2 months after recruitment. The trial feasibility will be assessed by: determining acceptability of the intervention to clinicians and parent/carers; quantifying differential recruitment and follow-up; determining intervention fidelity; the success in gathering the data necessary to conduct a cost-effectiveness analysis; and collecting data about antibiotic prescribing rates to inform the sample size needed for a fully powered RCT. Ethics and dissemination The study was approved by the North West—Haydock Research Ethics Committee, UK (reference

  11. 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.

  12. 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

  13. 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...... of possibly different cryptosystems. We then map transition systems to Markov chains and evaluate performance of systems, using standard tools....

  14. 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...

  15. From protocol to published report

    DEFF Research Database (Denmark)

    Berendt, Louise; Callréus, Torbjörn; Petersen, Lene Grejs;

    2016-01-01

    %) of the sample, and 87% (95% CI: 80 to 94%) of the trials were hospital based. CONCLUSIONS: Overall consistency between protocols and their corresponding published reports was low. Motivators for the inconsistencies are unknown but do not seem restricted to economic incentives....

  16. Improving the DGK comparison protocol

    NARCIS (Netherlands)

    Veugen, P.J.M.

    2012-01-01

    When processing signals in the encrypted domain, homomorphic encryption can be used to enable linear operations on encrypted data. Comparison of encrypted data however requires an additional protocol between the parties and will be relatively expensive. A well-known and frequently used comparison pr

  17. 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.

  18. 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...

  19. 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.

  20. Automata-theoretic protocol programming

    NARCIS (Netherlands)

    Jongmans, Sung-Shik Theodorus Quirinus

    2016-01-01

    Parallel programming has become essential for writing scalable programs on general hardware. Conceptually, every parallel program consists of workers, which implement primary units of sequential computation, and protocols, which implement the rules of interaction that workers must abide by. As progr

  1. 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…

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. Implementation and evaluation of a protocol management system for automated review of CT protocols.

    Science.gov (United States)

    Grimes, Joshua; Leng, Shuai; Zhang, Yi; Vrieze, Thomas; McCollough, Cynthia

    2016-09-08

    Protocol review is important to decrease the risk of patient injury and increase the consistency of CT image quality. A large volume of CT protocols makes manual review labor-intensive, error-prone, and costly. To address these challenges, we have developed a software system for automatically managing and monitoring CT proto-cols on a frequent basis. This article describes our experiences in the implementation and evaluation of this protocol monitoring system. In particular, we discuss various strategies for addressing each of the steps in our protocol-monitoring workflow, which are: maintaining an accurate set of master protocols, retrieving protocols from the scanners, comparing scanner protocols to master protocols, reviewing flagged differences between the scanner and master protocols, and updating the scanner and/or master protocols. In our initial evaluation focusing only on abdo-men and pelvis protocols, we detected 309 modified protocols in a 24-week trial period. About one-quarter of these modified protocols were determined to contain inappropriate (i.e., erroneous) protocol parameter modifications that needed to be corrected on the scanner. The most frequently affected parameter was the series description, which was inappropriately modified 47 times. Two inappropriate modifications were made to the tube current, which is particularly important to flag as this parameter impacts both radiation dose and image quality. The CT protocol changes detected in this work provide strong motivation for the use of an automated CT protocol quality control system to ensure protocol accuracy and consistency.

  7. Implementation and evaluation of a protocol management system for automated review of CT protocols.

    Science.gov (United States)

    Grimes, Joshua; Leng, Shuai; Zhang, Yi; Vrieze, Thomas; McCollough, Cynthia

    2016-01-01

    Protocol review is important to decrease the risk of patient injury and increase the consistency of CT image quality. A large volume of CT protocols makes manual review labor-intensive, error-prone, and costly. To address these challenges, we have developed a software system for automatically managing and monitoring CT proto-cols on a frequent basis. This article describes our experiences in the implementation and evaluation of this protocol monitoring system. In particular, we discuss various strategies for addressing each of the steps in our protocol-monitoring workflow, which are: maintaining an accurate set of master protocols, retrieving protocols from the scanners, comparing scanner protocols to master protocols, reviewing flagged differences between the scanner and master protocols, and updating the scanner and/or master protocols. In our initial evaluation focusing only on abdo-men and pelvis protocols, we detected 309 modified protocols in a 24-week trial period. About one-quarter of these modified protocols were determined to contain inappropriate (i.e., erroneous) protocol parameter modifications that needed to be corrected on the scanner. The most frequently affected parameter was the series description, which was inappropriately modified 47 times. Two inappropriate modifications were made to the tube current, which is particularly important to flag as this parameter impacts both radiation dose and image quality. The CT protocol changes detected in this work provide strong motivation for the use of an automated CT protocol quality control system to ensure protocol accuracy and consistency. PMID:27685112

  8. 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.)

  9. 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

  10. 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).

  11. 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.

  12. 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.

  13. 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...

  14. 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.

  15. 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...... to the 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....

  16. 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.

  17. Clinical diagnosis and treatment protocol for pediatric acute respiratory distress syndrome%小儿急性呼吸窘迫综合征诊疗技术规范--南京医科大学附属南京儿童医院急诊医学科/重症医学科诊疗技术规范

    Institute of Scientific and Technical Information of China (English)

    喻文亮

    2016-01-01

    本文介绍一家三级儿童医院重症医学科的小儿急性呼吸窘迫综合征的技术诊疗规范,包括其病因判断、诊断标准、诊断时注意事项、诊断流程图、辅助检查及治疗等。在治疗中强调了病因治疗、保守补液、肺保护性通气策略、俯卧位通气及镇痛镇静肌松等。%Acute respiratory distress syndrome (ARDS )is a severe disease with high short term mortality.We introduce a pediatric clinical practice protocol of diagnosis and treatment of ARDS which in-clude its origin,diagnosis standard,diagnosis flowchart,accessory examination and treatment.Lung protective ventilation,fluid therapy,prone position ventilation and sedation are underlined in the treatment of ARDS.

  18. 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...

  19. 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...

  20. Static Validation of a Voting Protocol

    DEFF Research Database (Denmark)

    Nielsen, Christoffer Rosenkilde; Andersen, Esben Heltoft; Nielson, Hanne Riis

    2005-01-01

    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 formalised in an extension of the LySa process calculus with blinding signatures. The analysis, which is fully automatic, pinpoints previously undiscovered flaws related to verifiability and accuracy and we suggest modifications of the protocol needed for validating these properties....

  1. 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.

  2. 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.

  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. 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. Bioinspired Security Analysis of Wireless Protocols

    DEFF Research Database (Denmark)

    Petrocchi, Marinella; Spognardi, Angelo; Santi, Paolo

    2016-01-01

    work, this paper investigates feasibility of adopting fraglets as model for specifying security protocols and analysing their properties. In particular, we give concrete sample analyses over a secure RFID protocol, showing evolution of the protocol run as chemical dynamics and simulating an adversary...

  7. 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.

  8. Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol

    Science.gov (United States)

    Furberg, Robert D; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

    2016-01-01

    Background Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Objective Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. Methods The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care–related infections were reviewed to develop the infection control protocol to support tablet maintenance. Results This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. Conclusions These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings. PMID:27350013

  9. Epidemic Protocols for Pervasive Computing Systems - Moving Focus from Architecture to Protocol

    DEFF Research Database (Denmark)

    Mogensen, Martin

    2009-01-01

    epidemic protocols as distribution mechanism for pervasive systems. The nature of epidemic protocols make them easy to implement, easy to deploy, and resilient to failures. By using epidemic protocols, it is possible to mitigate a wide range of the potential issues on the protocol layer. The result...

  10. 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

  11. 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.

  12. 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.

  13. Reactive broadcasting protocol for video on demand

    Science.gov (United States)

    Paris, Jehan-Francois; Carter, Steven W.; Long, Darrell D. E.

    1999-12-01

    We propose a reactive broadcasting protocol that addresses the problem of distributing moderately popular videos in a more efficient fashion. Like all efficient broadcasting protocols, reactive broadcasting assumes that the customer set-top box has enough local storage to store at least one half of each video being watched. Unlike other broadcasting protocols, reactive broadcasting only broadcasts the later portions of each video. the initial segment of each video is distributed on demand using a stream tapping protocol. Our simulations show that reactive broadcasting outperforms both conventional broadcasting protocols and pure stream tapping for a wide range of video request rates.

  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. 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.

  16. 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.

  17. 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 .

  18. 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.

  19. 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.

  20. Security Protocols: Specification, Verification, Implementation, and Composition

    DEFF Research Database (Denmark)

    Almousa, Omar

    An important aspect of Internet security is the security of cryptographic protocols that it deploys. We need to make sure that such protocols achieve their goals, whether in isolation or in composition, i.e., security protocols must not suffer from any aw that enables hostile intruders to break...... their security. Among others, tools like OFMC [MV09b] and Proverif [Bla01] are quite efficient for the automatic formal verification of a large class of protocols. These tools use different approaches such as symbolic model checking or static analysis. Either approach has its own pros and cons, and therefore, we...... called SPS (Security Protocol Specification) language, that enables users, without requiring deep expertise in formal models from them, to specify a wide range of real-world protocols in a simple and intuitive way. Thus, SPS allows users to verify their protocols using different tools, and generate...

  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. A Secure Short Message Communication Protocol

    Institute of Scientific and Technical Information of China (English)

    Chao-Wen Chang; Heng Pan; Hong-Yong Jia

    2008-01-01

    According to the security requirement of the short message service (SMS) industry application, a secure short message communication protocol is proposed. This is an application level protocol constructed on the standard SMS communication protocol using public key authentication and key agreement without the need of wireless public key infrastructure (WPKI). Secure short message transmission and dynamic key agreement between mobile terminals and the accessing gateway are realized. The security of the proposed protocol is validated through the BAN logic. Compared with the standard SMS protocol, the effective payload rate of our protocol can reach 91.4%, and subscriber identity module (SIM) tool kit (STK) applications based on our protocol suit well for all kinds of mobile terminals in practical application.

  3. 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.

  4. 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...

  5. 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.

  6. 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

  7. 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...

  8. 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

  9. Pregnancy loss after frozen-embryo transfer--a comparison of three protocols

    DEFF Research Database (Denmark)

    Tomás, Candido; Alsbjerg, Birgit; Martikainen, Hannu;

    2012-01-01

    OBJECTIVE: To compare the reproductive outcome of three protocols for frozen ET treatment. DESIGN: Retrospective follow-up study. SETTING: Two public clinics and one private clinic. PATIENT(S): Four thousand four hundred seventy frozen ET cycles between 2006 and 2010. INTERVENTION(S): Thawing of ...

  10. 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.

  11. 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)

  12. Research on Routing Protocol of Mobile Ad Hoc Network

    OpenAIRE

    Tuo Ming Fu; Che Min

    2016-01-01

    Routing protocol is an important content of mobile Ad Hoc. The typical mobile Ad Hoc network routing protocols is introduced. The advantages and disadvantages of these routing protocols are analyzed. A hybrid routing protocol is put forward based on this.

  13. Adherence to guidelines and protocols in the prehospital and emergency care setting: a systematic review

    OpenAIRE

    Ebben, R.H.A.; Vloet, L.C.M.; Verhofstad, M.H.J.; Meijer, S.; de Groot, J.; van Achterberg, T

    2013-01-01

    A gap between guidelines or protocols and clinical practice often exists, which may result in patients not receiving appropriate care. Therefore, the objectives of this systematic review were (1) to give an overview of professionals' adherence to (inter)national guidelines and protocols in the emergency medical dispatch, prehospital and emergency department (ED) settings, and (2) to explore which factors influencing adherence were described in studies reporting on adherence. PubMed (including...

  14. 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...

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. [The research protocol. Part I].

    Science.gov (United States)

    Miranda-Novales, María Guadalupe; Villasís-Keever, Miguel Ángel

    2015-01-01

    One of the principal aims in research is the publication of the study in scientific journals. This implies two challenges: the first one, the election of an adequate research design, and the second one, the concrete and simple wording of the results for the study to be accepted in the most appropriate journal according to the scope. Despite numerous supporting documents are available for both issues, the publication process is long, tiresome, and can discourage the most enthusiastic researcher. This is the first of a series of articles with the objective to describe the steps from the research question to the publication of the study. First of all, the importance of the research design will be addressed. The structure of the protocol is essential to achieve the objectives, and provides a way to organize the investigation in a logic, comprehensible and efficient manner.

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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.

  11. 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...

  12. 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...

  13. 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].

  14. 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.

  15. 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.

  16. 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

  17. Quantum three-pass cryptography protocol

    Science.gov (United States)

    Yang, Li; Wu, Ling-An; Liu, Songhao

    2002-09-01

    We present a new kind of quantum cryptography protocol based on Shamir's three-pass protocol of classical cryptography, which allows the transmission of qubits directly and secretly via the aid of an unjammable classical channel. In this protocol we implement the encryption and decryption transformations via rotations on the Poincare sphere of the photons polarization parameters. The key technique is that Bob's encryption rotation must be commutative with Alice s decryption rotation; this means that the axes of these two rotations must be parallel. We also present a security analysis of the protocol under a man-in-the-middle attack.

  18. Network Coding Protocols for Smart Grid Communications

    DEFF Research Database (Denmark)

    Prior, Rui; Roetter, Daniel Enrique Lucani; Phulpin, Yannick;

    2014-01-01

    We propose a robust network coding protocol for enhancing the reliability and speed of data gathering in smart grids. At the heart of our protocol lies the idea of tunable sparse network coding, which adopts the transmission of sparsely coded packets at the beginning of the transmission process...... but then switches to a denser coding structure towards the end. Our systematic mechanism maintains the sparse structure during the recombination of packets at the intermediate nodes. The performance of our protocol is compared by means of simulations of IEEE reference grids against standard master-slave protocols...

  19. 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.

  20. A New Watermarking Protocol against Conspiracy

    Institute of Scientific and Technical Information of China (English)

    ZHANG Jun; KOU Weidong; FAN Kai; CAO Xuefei

    2006-01-01

    A trusted third party introduced in watermarking protocols would decrease the security and affect the implementation of the protocols. In this paper, a new watermarking protocol with an un-trusted third party (UTTP) was proposed. Based on the idea of all-or-nothing disclosure of secret (ANDOS), all of the buyer, the seller and the third party didn't know the exact watermark, which was embedded in a digital content for tracing piracy. The proposed protocol provided mechanisms to trace piracy and protect customer's right. In addition, the problem that a seller colluded with UTTP to frame the buyer, namely, the conspiracy problem, could be avoided.

  1. Tool Supported Analysis of Web Services Protocols

    DEFF Research Database (Denmark)

    Marques, Abinoam P.; Ravn, Anders Peter; Srba, Jiri;

    2011-01-01

    We describe an abstract protocol model suitable for modelling of web services and other protocols communicating via unreliable, asynchronous communication channels. The model is supported by a tool chain where the first step translates tables with state/transition protocol descriptions, often used...... e.g. in the design of web services protocols, into an intermediate XML format. We further translate this format into a network of communicating state machines directly suitable for verification in the model checking tool UPPAAL. We introduce two types of communication media abstractions in order...

  2. Multimode Communication Protocols Enabling Reconfigurable Radios

    Directory of Open Access Journals (Sweden)

    Berlemann Lars

    2005-01-01

    Full Text Available This paper focuses on the realization and application of a generic protocol stack for reconfigurable wireless communication systems. This focus extends the field of software-defined radios which usually concentrates on the physical layer. The generic protocol stack comprises common protocol functionality and behavior which are extended through specific parts of the targeted radio access technology. This paper considers parameterizable modules of basic protocol functions residing in the data link layer of the ISO/OSI model. System-specific functionality of the protocol software is realized through adequate parameterization and composition of the generic modules. The generic protocol stack allows an efficient realization of reconfigurable protocol software and enables a completely reconfigurable wireless communication system. It is a first step from side-by-side realized, preinstalled modes in a terminal towards a dynamic reconfigurable anymode terminal. The presented modules of the generic protocol stack can also be regarded as a toolbox for the accelerated and cost-efficient development of future communication protocols.

  3. 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

  4. Secure Key Management Protocol in WIMAX

    Directory of Open Access Journals (Sweden)

    Noudjoud Kahya

    2012-12-01

    Full Text Available The Worldwide Interoperability for Microwave Access (WIMAX /IEEE 802.16, is new technology basedon wireless metropolitan area network. Security of connections access in WIMAX /IEEE 802.16 iscomplete with respect to the Privacy Key Management (PKM protocol. The protocol is responsible forproviding the secure distribution of keying data from Base Station (BS to Subscriber Station (SS. In thispaper we provide the formal analysis of PKMv2 using Scyther tool to verify the security properties. Wefound that PKMv2 is vulnerable to replay, DoS, Man-in-the middle attacks. At last we have proposed asecure protocol (SPKM to prevent the authorization protocol from such attacks.

  5. 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

  6. Equilibria of Generalized Cut and Choose Protocols

    DEFF Research Database (Denmark)

    Branzei, Simina; Caragiannis, Ioannis; Kurokawa, David;

    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...

  7. UCSF Protocol for Caries Arrest Using Silver Diamine Fluoride: Rationale, Indications and Consent.

    Science.gov (United States)

    Horst, Jeremy A; Ellenikiotis, Hellene; Milgrom, Peter L

    2016-01-01

    The Food and Drug Administration recently cleared silver diamine fluoride for reducing tooth sensitivity. Clinical trials document arrest and prevention of dental caries by silver diamine fluoride. This off-label use is now permissible and appropriate under U.S. law. A CDT code was approved for caries arresting medicaments for 2016 to facilitate documentation and billing. We present a systematic review, clinical indications, clinical protocol and consent procedure to guide application for caries arrest treatment. PMID:26897901

  8. 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...

  9. 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

  10. Clinical investigation program, fiscal year 1991

    Science.gov (United States)

    Schydlower, Manuel

    1992-02-01

    Subject report identifies the research activities conducted at William Beaumont Army Medical Center by investigators who had protocols approved by the Clinical Investigation Committee, the Institutional Review Board, and the Animal Use Committee. This report includes all protocols registered with the Department of Clinical Investigation during FY 1991. All known presentations and publications are also included. The research protocols described were conducted under the provisions of AR 40-38 (Clinical Investigation Program); AR 40-7 (Use of Investigational Drugs in Humans and the Use of Schedule 1 Controlled Substances); AR 70-25 (Usle of Volunteers as Subjects of Research); HSC 40-32 (Management of Clinical Investigation Protocols and Reports); and AR 70-18 (The Use of Animals in DOS programs).

  11. Estimating return on investment in translational research: methods and protocols.

    Science.gov (United States)

    Grazier, Kyle L; Trochim, William M; Dilts, David M; Kirk, Rosalind

    2013-12-01

    Assessing the value of clinical and translational research funding on accelerating the translation of scientific knowledge is a fundamental issue faced by the National Institutes of Health (NIH) and its Clinical and Translational Awards (CTSAs). To address this issue, the authors propose a model for measuring the return on investment (ROI) of one key CTSA program, the clinical research unit (CRU). By estimating the economic and social inputs and outputs of this program, this model produces multiple levels of ROI: investigator, program, and institutional estimates. A methodology, or evaluation protocol, is proposed to assess the value of this CTSA function, with specific objectives, methods, descriptions of the data to be collected, and how data are to be filtered, analyzed, and evaluated. This article provides an approach CTSAs could use to assess the economic and social returns on NIH and institutional investments in these critical activities.

  12. A prospective study of GnRH long agonist versus flexible GnRH antagonist protocol in PCOS: Indian experience

    Directory of Open Access Journals (Sweden)

    Harpreet Kaur

    2012-01-01

    Full Text Available Background: Polycystic ovarian syndrome is a common endocrine disorder of reproductive age women. Many controlled ovarian stimulation (COS strategies have been offered for the treatment of patients with PCOS undergoing in vitro fertilization, but the optimal protocol is still a controversy. There is no compelling evidence for the advantage of one stimulation protocol over the other. Materials and Methods: This is a single-center prospective controlled study comparing long agonist and antagonist protocol in PCOS women. Results: There was no significant difference in live birth rate and clinical pregnancy rate. Rate of ovarian hyperstimulation syndrome was significantly higher in the agonist group. Number of oocytes retrieved, number of follicles and peak estradiol levels were significantly more in the agonist group. Conclusion: The GnRH antagonist protocol is an equally effective but safer protocol in PCOS patients compared with the long agonist protocol.

  13. 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

  14. 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

  15. Comparison between a GnRH Agonist and a GnRH Antagonist Protocol for the Same Patient Undergoing IVF

    Institute of Scientific and Technical Information of China (English)

    Yufeng LI; Yuan LI; Qiaohong LAI; Hanwang ZHANG; Guijin ZHU; Lei JIN; Jing YUE

    2008-01-01

    Summary: In order to compare GnRH agonist with antagonist protocol for the same patient during controlled ovarian stimulation cycles, the in vitro fertilization and embryo transfer (IVF-ET) outcome was retrospectively studied in 81 patients undergoing 105 agonist protocols and 88 antagonist protocols. The results showed that there was no statistically significant difference in duration of ovarian stimulation, number of ampoules, oocytes retrieved, serum estradiol (E2) and progesterone (P) levels,thickness of endometrium, the zygote-and blastocyst-developmcnt rate between GnRH agonist and antagonist protocols (P>0.05). High quality embryo rate was higher in antagonist protocols, but there was no significant difference between two protocols. Implantation rate and clinical pregnant rate were significantly higher in antagonist protocol (15.82% and 30.26%, respectively) than in agonist protocol (5.26% and 10.64% respectively (P<0.05). It was concluded GnRH antagonist protocol probably improved the outcome of pregnancy of older patients with a history of multiple failure of IVF-ET in a GnRH protocol.

  16. Analysis of a security protocol in ?CRL

    NARCIS (Netherlands)

    Pang, J.

    2002-01-01

    Needham-Schroeder public-key protocol; With the growth and commercialization of the Internet, the security of communication between computers becomes a crucial point. A variety of security protocols based on cryptographic primitives are used to establish secure communication over insecure open netwo

  17. Diagrammatization of the Transmission Control Protocol

    Directory of Open Access Journals (Sweden)

    Sabah Al-Fedaghi

    2012-09-01

    Full Text Available With the wide spread of Internet services, developers and users need a greater understanding of the technology of networking. Acquiring a clear understanding of communication protocols is an important step in understanding how a network functions; however, many protocols are complicated, and explaining them can be demanding. In addition, protocols are often explained in terms of traffic analysis and oriented toward technical staff and those already familiar with network protocols. This paper aims at proposing a diagrammatic methodology to represent protocols in general, with a focus on the Transmission Control Protocol and Secure Sockets Layer in particular. The purpose is to facilitate understanding of protocols for learning and communication purposes. The methodology is based on the notion of flow of primitive things in a system with six stages: creation, release, transfer, arrival, acceptance, and processing. Though the method presents a basic description of protocols without in-depth analysis of all aspects and mechanisms, the resultant conceptual description is a systematic specification that utilizes a few basic notions that assist in illustrating functionality and support comprehension.

  18. Climate Change And The Kyoto Protocol

    International Nuclear Information System (INIS)

    The problem of global warming is addressed. Changes in earth surface temperature, emission of CO2 and other four major green house gases are presented. Effect of global warming on weather, ocean, and ecosystem is discussed. A brief history of the Kyoto protocol starting from the 151 Earth Summit in 1972 is outlined. An overview of the protocol and a brief summary are given

  19. Kyoto Protocol: trade versus the environment

    International Nuclear Information System (INIS)

    Could the signatories to the Kyoto Protocol find themselves up against the WTO? This paper examines how the climate change agreement could conflict with trade rules, and shows that there are potentially serious conflicts in the interface between the WTO and the Kyoto Protocol. It argues for dialogue and debate before it is too late. (author)

  20. Performance of a connectionless protocol over ATM

    NARCIS (Netherlands)

    Heijenk, Geert J.; Moorsel, van Aad P.A.; Niemegeers, Ignas G.

    1992-01-01

    Recent studies show the existence of a demand for a connectionless broadband service. In order to cope with this demand, a connectionless protocol for the B-ISDN needs to be designed. Such a protocol should make use of ATM and the ATM Adaptation Layer. It needs to specify destination and bandwidth o

  1. Summary Report on Rational Cryptographic Protocols

    DEFF Research Database (Denmark)

    Alwen, Joël; Cachin, Christian; Pereira, Olivier;

    This report gives an overview of some of the models and techniques in rational cryptography, an emerging research area which in particular uses the methodologies and techniques of game theory to analyze cryptographic protocols and which uses cryptographic protocol theory to implement game theoretic...

  2. Welfare monitroing system : assessment protocol for horses

    NARCIS (Netherlands)

    Livestock Research,

    2012-01-01

    This document describes the protocol for horses in more detail. For the development of the protocol the Welfare Quality® framework was used. For each measure there is a description how to assess the measure including the method of classification.

  3. 40 CFR 161.70 - Acceptable protocols.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Acceptable protocols. 161.70 Section 161.70 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS DATA... Development (OECD) Protocols. Tests conducted in accordance with the requirements and recommendations of...

  4. The Formal Specifications for Protocols of Decoders

    Institute of Scientific and Technical Information of China (English)

    YUAN Meng-ting; WU Guo-qing; SHU Feng-di

    2004-01-01

    This paper presents a formal approach, FSPD (Formal Specifications for Protocols of Decoders), to specify decoder communication protocols. Based on axiomatic, FSPD is a precise language with which programmers could use only one suitable driver to handle various types of decoders. FSPD is helpful for programmers to get high adaptability and reusability of decoder-driver software.

  5. Secure Geographic Routing Protocols: Issues and Approaches

    CERN Document Server

    sookhak, Mehdi; Haghparast, Mahboobeh; ISnin, Ismail Fauzi

    2011-01-01

    In the years, routing protocols in wireless sensor networks (WSN) have been substantially investigated by researches. Most state-of-the-art surveys have focused on reviewing of wireless sensor network .In this paper we review the existing secure geographic routing protocols for wireless sensor network (WSN) and also provide a qualitative comparison of them.

  6. Secure Geographic Routing Protocols: Issues and Approaches

    Directory of Open Access Journals (Sweden)

    Mehdi sookhak

    2011-09-01

    Full Text Available In the years, routing protocols in wireless sensor networks (WSN have been substantially investigated by researches Most state-of-the-art surveys have focused on reviewing of wireless sensor network .In this paper we review the existing secure geographic routing protocols for wireless sensor network (WSN and also provide a qualitative comparison of them.

  7. Forests and the Kyoto Protocol

    Energy Technology Data Exchange (ETDEWEB)

    Goetze, D.C. [Environment Canada, Ottawa, ON (Canada)

    2001-07-01

    This PowerPoint presentation referred to carbon sinks in the Clean Development Mechanism (CDM) as specified in the Kyoto Protocol. Policy issues, opportunities and challenges were discussed. The slides summarized the environmental potential of carbon sink projects, the current status of carbon sinks in the CDM, and strategies towards a CDM carbon sink. The Nyakach, Kenya biomass enhancement case study was presented, along with the Colombian Andean biodiversity corridor reforestation project. Potential sink projects were described as those resulting in direct reduction of emissions. These include reducing deforestation by protecting forests from being converted to agriculture, by protecting forests from the impacts of human activities, and by substituting biomass energy sources for fossil fuels. Indirect reduction of emissions via sequestration involves restoring natural forests in deforested or degraded areas and expanding agroforests and plantations. The co-benefits of carbon sink projects are biodiversity and socio-economic benefits. Under the Bonn Agreement, afforestation and reforestation projects are eligible under the CDM. Credits are limited to 1 per cent of Annex 1 party's base year emissions per year. The important elements of the Marrakech Accord are the prompt start of the CDM, as well as modalities and procedures.

  8. Quantum Communication Complexity of Quantum Authentication Protocols

    CERN Document Server

    Guedes, Elloá B

    2011-01-01

    In order to perform Quantum Cryptography procedures it is often essencial to ensure that the parties of the communication are authentic. Such task is accomplished by quantum authentication protocols which are distributed algorithms based on the intrinsic properties of Quantum Mechanics. The choice of an authentication protocol must consider that quantum states are very delicate and that the channel is subject to eavesdropping. However, even in face of the various existing definitions of quantum authentication protocols in the literature, little is known about them in this perspective, and this lack of knowledge may unfavor comparisons and wise choices. In the attempt to overcome this limitation, in the present work we aim at showing an approach to evaluate quantum authentication protocols based on the determination of their quantum communication complexity. Based on our investigation, no similar methods to analyze quantum authentication protocols were found in the literature. Pursuing this further, our approa...

  9. Security Weaknesses in Arbitrated Quantum Signature Protocols

    Science.gov (United States)

    Liu, Feng; Zhang, Kejia; Cao, Tianqing

    2014-01-01

    Arbitrated quantum signature (AQS) is a cryptographic scenario in which the sender (signer), Alice, generates the signature of a message and then a receiver (verifier), Bob, can verify the signature with the help of a trusted arbitrator, Trent. In this paper, we point out there exist some security weaknesses in two AQS protocols. Our analysis shows Alice can successfully disavow any of her signatures by a simple attack in the first protocol. Furthermore, we study the security weaknesses of the second protocol from the aspects of forgery and disavowal. Some potential improvements of this kind of protocols are given. We also design a new method to authenticate a signature or a message, which makes AQS protocols immune to Alice's disavowal attack and Bob's forgery attack effectively.

  10. Cryptanalysis of the arbitrated quantum signature protocols

    Science.gov (United States)

    Gao, Fei; Qin, Su-Juan; Guo, Fen-Zhuo; Wen, Qiao-Yan

    2011-08-01

    As a new model for signing quantum messages, arbitrated quantum signature (AQS) has recently received a lot of attention. In this paper we study the cryptanalysis of previous AQS protocols from the aspects of forgery and disavowal. We show that in these protocols the receiver, Bob, can realize existential forgery of the sender's signature under known message attack. Bob can even achieve universal forgery when the protocols are used to sign a classical message. Furthermore, the sender, Alice, can successfully disavow any of her signatures by simple attack. The attack strategies are described in detail and some discussions about the potential improvements of the protocols are given. Finally we also present several interesting topics on AQS protocols that can be studied in future.

  11. Cryptanalysis of the arbitrated quantum signature protocols

    CERN Document Server

    Gao, Fei; Guo, Fen-Zhuo; Wen, Qiao-Yan

    2011-01-01

    As a new model for signing quantum message, arbitrated quantum signature (AQS) has recently received a lot of attention. In this paper we study the cryptanalysis of previous AQS protocols from the aspects of forgery and disavowal. We show that in these protocols the receiver Bob can realize existential forgery of the sender's signature under known message attack. Bob can even achieve universal forgery when the protocols are used to sign a classical message. Furthermore, the sender Alice can successfully disavow any of her signatures by simple attack. The attack strategies are described in detail and some discussions about the potential improvements of the protocols are given. Finally we also present several interesting topics in future study on AQS protocols.

  12. VULNERABILITIES OF THE SSL/TLS PROTOCOL

    Directory of Open Access Journals (Sweden)

    Jelena Ćurguz

    2016-05-01

    Full Text Available 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 attack, the potential consequences, but also studying methods of defense. All versions of the protocol are going to be the subject of the research but emphasis will be placed on the critical attack that the most endanger the safety of data. The goal of the research is to point out the danger of existence of at least vulnerability in the SSL/TLS protocol, which can be exploited and endanger the safety of the data that should be protected.

  13. Multicast Protocol for Uni-Directional Networks

    Institute of Scientific and Technical Information of China (English)

    黄皓; 陈贵海; 谢立; 孙钟秀

    2000-01-01

    A very inexpensive receive-only satellite receiver can receive high bandwidth traffic from a feeder. Therefore the connection between the feeder and the receiver is uni-directional. The existing routing protocols, such as Link-State and Distance-Vector, are designed on the premise that any links are bidirectional and they cannot handle the uni-directional links. In this paper, a dynamic multicast routing protocol is proposed, which can handle uni-directional networks. This protocol can also adapt to the dynamic change of the topology of the network and has good scalability. A formal description of the protocol by Petri net is given. Liveness,deadlock free and other properties of the protocol are proved.

  14. How blockchain-timestamped protocols could improve the trustworthiness of medical science

    Science.gov (United States)

    Irving, Greg; Holden, John

    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 we confirm the use of blockchain as a low cost, independently verifiable method to audit and confirm the reliability of scientific studies. PMID:27239273

  15. How blockchain-timestamped protocols could improve the trustworthiness of medical science.

    Science.gov (United States)

    Irving, Greg; Holden, John

    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 we confirm the use of blockchain as a low cost, independently verifiable method to audit and confirm the reliability of scientific studies. PMID:27239273

  16. How blockchain-timestamped protocols could improve the trustworthiness of medical science.

    Science.gov (United States)

    Irving, Greg; Holden, John

    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 we confirm the use of blockchain as a low cost, independently verifiable method to audit and confirm the reliability of scientific studies.

  17. Optimization of Protocol CT, PET-CT, whole body

    International Nuclear Information System (INIS)

    The objective of this study was to optimize the acquisition protocols and processing existing of the CT PET/CT scanner for clinical use of Nuclear Diagnostic Center Foundation, a way to minimize the radiation dose while maintaining diagnostic image quality properly. Dosimetric data of PET / CT service were surveyed and obtained the baseline against which we compare and define strategies and modifications to develop online. We selected transaxial up to the pulmonary hilum and liver slices as the anatomical regions of interest that led to the standardization of the study

  18. A vascular laboratory protocol for improving and managing after-hours suspected acute deep venous thrombosis.

    Science.gov (United States)

    Martin, Angela H; Eckert, George; Lemmon, Gary W; Sawchuk, Alan; Dalsing, Michael C

    2014-04-01

    This study reviews the clinical and workforce impact of a suggested protocol designed for the management of suspected acute deep venous thrombosis (DVT) in patients seen after standard vascular laboratory business hours. The protocol included the use of Wells score, D-dimer and a single dose of therapeutic anticoagulant to defer venous duplex ultrasound (VDU) testing until routine business hours unless contraindicated. Information was collected on medical history, physical exam and the timing of any diagnostic studies and treatment provided. Over 15% of studies done after-hours were deemed unnecessary by our protocol and in every individual the results were negative for an acute DVT. There were no adverse events from a one-time dose of anticoagulant. Limiting emergency VDU coverage to evaluate for acute DVT based on a management protocol can eliminate unnecessary after-hours VDU testing without having a negative impact on patient care.

  19. A fully efficient secure quantum cryptography protocol

    CERN Document Server

    Xiang Bin Wang

    2001-01-01

    Since Bennett and Brassard suggested their quantum key distribution protocol(BB84 protocol) in 1984, the subject has been extensively studied both theoretically and experimentally. The protocol allows two remote parties Alice and Bob to create and share a secret key using a quantum channel and public authenticated communications. The quantum key created in this way is in principle secure because eavesdroppers have no way to tap the quantum channel without disturb it. In the protocol, two level quantum bits are measured in two basis, $X$ and $Z$ randomly by Bob. So at least half of the measurement results will be discarded because Bob has a half probability taking the measurement in a wrong basis. On the other hand, the security is not the maximum in BB84 protocol. To increase the security, one may straightforwardly increase the number of basis used in the protocol. For example, six state protocol was proposed recently for two level system. However, in this way, it seems to be the case that the higher the secu...

  20. Efficient Privacy Preserving Protocols for Similarity Join

    Directory of Open Access Journals (Sweden)

    Bilal Hawashin

    2012-04-01

    Full Text Available During the similarity join process, one or more sources may not allow sharing its data with other sources. In this case, a privacy preserving similarity join is required. We showed in our previous work [4] that using long attributes, such as paper abstracts, movie summaries, product descriptions, and user feedbacks, could improve the similarity join accuracy using supervised learning. However, the existing secure protocols for similarity join methods can not be used to join sources using these long attributes. Moreover, the majority of the existing privacy‐preserving protocols do not consider the semantic similarities during the similarity join process. In this paper, we introduce a secure efficient protocol to semantically join sources when the join attributes are long attributes. We provide two secure protocols for both scenarios when a training set exists and when there is no available training set. Furthermore, we introduced the multi‐label supervised secure protocol and the expandable supervised secure protocol. Results show that our protocols can efficiently join sources using the long attributes by considering the semantic relationships among the long string values. Therefore, it improves the overall secure similarity join performance.

  1. Energy Efficient Routing Protocol for MANET

    Directory of Open Access Journals (Sweden)

    S.Gopinath

    2012-03-01

    Full Text Available In recent years, many energy-efficient routing protocols have been proposed. However, very little efforts have been taken in studying the energy consumption of individual node, overhead and route maintaining issues. While not considering the design of energy efficient routing protocol, it may perform very worst than the normal routing protocol. Here, we have proposed On Demand Based Energy Efficient Routing Protocol (ODBEERP. The main aim of proposed protocol is to discover the minimum power-limitation route. The power limitation of a route is decided by the node which has the minimum energy in that route. So compared with the minimum node energy in any other route, the minimum node energy in the minimum power-limitation route has more energy. We have also proposed a more accurate analysis to track the energy consumptions due to various factors, and improve the performance during path discovery and in mobility scenarios. The proposed protocol is evaluated with object oriented discrete event simulator environment. Simulation results shows that the ODBEERP achieves good throughput, less delay, high packet delivery ratio and good energy efficiency than the existing protocol PEER.

  2. Comparison of Three Prehospital Cervical Spine Protocols for Missed Injuries

    Directory of Open Access Journals (Sweden)

    Rick Hong

    2014-07-01

    Full Text Available Introduction: We wanted to compare 3 existing emergency medical services (EMS immobilization protocols: the Prehospital Trauma Life Support (PHTLS, mechanism-based; the Domeier protocol (parallels the National Emergency X-Radiography Utilization Study [NEXUS] criteria; and the Hankins’ criteria (immobilization for patients 65 years, those with altered consciousness, focal neurologic deficit, distracting injury, or midline or paraspinal tenderness.To determine the proportion of patients who would require cervical immobilization per protocol and the number of missed cervical spine injuries, had each protocol been followed with 100% compliance. Methods: This was a cross-sectional study of patients ≥18 years transported by EMS post-traumatic mechanism to an inner city emergency department. Demographic and clinical/historical data obtained by physicians were recorded prior to radiologic imaging. Medical record review ascertained cervical spine injuries. Both physicians and EMS were blinded to the objective of the study. Results: Of 498 participants, 58% were male and mean age was 48 years. The following participants would have required cervical spine immobilization based on the respective protocol: PHTLS, 95.4% (95% CI: 93.1-96.9%; Domeier, 68.7% (95% CI: 64.5-72.6%; Hankins, 81.5% (95% CI: 77.9-84.7%. There were 18 cervical spine injuries: 12 vertebral fractures, 2 subluxations/dislocations and 4 spinal cord injuries. Compliance with each of the 3 protocols would have led to appropriate cervical spine immobilization of all injured patients. In practice, 2 injuries were missed when the PHTLS criteria were mis-applied. Conclusion: Although physician-determined presence of cervical spine immobilization criteria cannot be generalized to the findings obtained by EMS personnel, our findings suggest that the mechanism-based PHTLS criteria may result in unnecessary cervical spine immobilization without apparent benefit to injured patients. PHTLS

  3. ANALYSIS OF THE PROTECTED EXTENSIBLE AUTHENTICATION PROTOCOL

    Directory of Open Access Journals (Sweden)

    Amit Rana

    2012-09-01

    Full Text Available The Internet Engineering Task Force (IETF has proposednew protocols for highly secured wireless networking. Thepurpose of this paper is to implement one such proposedsecurity protocol - PEAP (Protected ExtensibleAuthentication Protocol [1]. PEAP was jointly developedby Microsoft, Cisco and RSA security. The protocolimplementation is done on the server end of a Client/Servernetwork model on a RADIUS server (RemoteAuthentication Dial-in User Service. The proposedprotocol - PEAP provides for Client identity protection andkey generation thus preventing unauthorized user accessand protecting or encrypting the data against maliciousactivities.

  4. Advanced Internet Protocols, Services, and Applications

    CERN Document Server

    Oki, Eiji; Tatipamula, Mallikarjun; Vogt, Christian

    2012-01-01

    Today, the internet and computer networking are essential parts of business, learning, and personal communications and entertainment. Virtually all messages or transactions sent over the internet are carried using internet infrastructure- based on advanced internet protocols. Advanced internet protocols ensure that both public and private networks operate with maximum performance, security, and flexibility. This book is intended to provide a comprehensive technical overview and survey of advanced internet protocols, first providing a solid introduction and going on to discu

  5. Demand Priority Protocol Simulation and Evaluation

    Institute of Scientific and Technical Information of China (English)

    ZHAN Yongzhao; SONG Shunlin; XIE Li

    1999-01-01

    A new network protocol (DemandPriority Protocol) environment can provide more satisfying service fordifferent urgent transmission requests. In this paper, in order toprovide guidance for the selection of environment of multimedia datatransmission in Computer Supported Cooperative Work better, anobject-oriented protocol specification language based on C++ is used todesign a virtual environment of multiworkstation of computer cooperativework and to simulate exe-cution of demand priority network protocoland then the performances of various transmission requests are analyzed.Finally, an evaluation of the demand priority LAN is given.

  6. The Russian Federation and the Kyoto Protocol

    OpenAIRE

    Douma, Wybe; Ratsiborinskaya, Daria

    2007-01-01

    textabstractThis book brings together the results of two conferences: 'The Kyoto Protocol and beyond: A legal perspective', organised by the University of Siena on 10-11 June 2006, and 'Tackling Climate Change: An appraisal of the Kyoto Protocol and options for the future', held at the T.M.C. Asser Institute in The Hague on 30-31 March 2007. These conferences focused on the legal aspects of the Kyoto Protocol implementation and the post-2012 regime. Experts in European and international envir...

  7. Security-Preserving Asymmetric Protocol Encapsulation

    OpenAIRE

    Vaudenay, Serge; Phan, Raphael C-W

    2007-01-01

    Query-response based protocols between a client and a server such as SSL, TLS, SSH are asymmetric in the sense that the querying client and the responding server play different roles, and for which there is a need for two-way linkability between queries and responses within the protocol. We are motivated by the observation that though results exist in other related contexts, no provably secure scheme has been applied to the setting of client-server protocols, which differ from conventional co...

  8. Performance evaluation of TCP over ABT protocols

    Science.gov (United States)

    Ata, Shingo; Murata, Masayuki; Miyahara, Hideo

    1998-10-01

    ABT is promising for effectively transferring a highly bursty data traffic in ATM networks. Most of past studies focused on the data transfer capability of ABT within the ATM layer. In actual, however, we need to consider the upper layer transport protocol since the transport layer protocol also supports a network congestion control mechanism. One such example is TCP, which is now widely used in the Internet. In this paper, we evaluate the performance of TCP over ABT protocols. Simulation results show that the retransmission mechanism of ABT can effectively overlay the TCP congestion control mechanism so that TCP operates in a stable fashion and works well only as an error recovery mechanism.

  9. Overview of the InterGroup protocols

    Energy Technology Data Exchange (ETDEWEB)

    Berket, Karlo [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Agarwal, Deborah A. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Melliar-Smith, P. Michael [Univ. of California, Santa Barbara, CA (United States); Moser, Louise E. [Univ. of California, Santa Barbara, CA (United States)

    2001-03-01

    Existing reliable ordered group communication protocols have been developed for local-area networks and do not, in general, scale well to large numbers of nodes and wide-area networks. The InterGroup suite of protocols is a scalable group communication system that introduces a novel approach to handling group membership, and supports a receiver-oriented selection of service. The protocols are intended for a wide-area network, with a large number of nodes, that has highly variable delays and a high message loss rate, such as the Internet. The levels of the message delivery service range from unreliable unordered to reliable group timestamp ordered.

  10. Analysis of Enhanced Associativity Based Routing Protocol

    Directory of Open Access Journals (Sweden)

    Said A. Shaar

    2006-01-01

    Full Text Available This study introduces an analysis to the performance of the Enhanced Associativity Based Routing protocol (EABR based on two factors; Operation complexity (OC and Communication Complexity (CC. OC can be defined as the number of steps required in performing a protocol operation, while CC can be defined as the number of messages exchanged in performing a protocol operation[1]. The values represent the worst-case analysis. The EABR has been analyzed based on CC and OC and the results have been compared with another routing technique called ABR. The results have shown that EABR can perform better than ABR in many circumstances during the route reconstruction.

  11. Analyzing security protocols in hierarchical networks

    DEFF Research Database (Denmark)

    Zhang, Ye; Nielson, Hanne Riis

    2006-01-01

    Validating security protocols is a well-known hard problem even in a simple setting of a single global network. But a real network often consists of, besides the public-accessed part, several sub-networks and thereby forms a hierarchical structure. In this paper we first present a process calculus...... capturing the characteristics of hierarchical networks and describe the behavior of protocols on such networks. We then develop a static analysis to automate the validation. Finally we demonstrate how the technique can benefit the protocol development and the design of network systems by presenting a series...

  12. Orthodontic treatment outcomes obtained by application of a finishing protocol

    Science.gov (United States)

    Carvajal-Flórez, Alvaro; Barbosa-Lis, Diana María; Zapata-Noreña, Oscar Arturo; Marín-Velásquez, Julissa Andrea; Afanador-Bayona, Sergio Andrés

    2016-01-01

    ABSTRACT Objective: To evaluate the results of a finishing protocol implemented in patients treated in the Orthodontics graduate program at Universidad de Antioquia. Evaluation was carried out by means of the criteria set by the Objective Grading System (OGS) of the American Board of Orthodontics (ABO). Methods: Cast models and panoramic radiographs of 34 patients were evaluated. The intervention group (IG) consisted of 17 patients (19.88 ± 4.4 years old) treated under a finishing protocol. This protocol included training in finishing, application of a finishing guide, brackets repositioning and patient's follow-up. Results of the IG were compared to a control group of 17 patients (21.88 ± 7.0 years old) selected by stratified randomization without finishing intervention (CG). Results: The scores for both CG and IG were 38.00 ± 9.0 and 31.41 ± 9.6 (p = 0.048), respectively. The score improved significantly in the IG group, mainly regarding marginal ridges (CG: 5.59 ± 2.2; IG: 3.65 ± 1.8) (p = 0.009) and root angulation (CG: 7.59 ± 2.8; IG: 4.88 ± 2.6) (p = 0.007). Criteria that did not improve, but had the highest scores were: alignment (CG: 6.35 ± 2.7; IG: 6.82 ± 2.8) (p = 0.62) and buccolingual inclination (CG: 3.6 ± 5.88; IG: 5.29 ± 3.9) (p = 0.65). Conclusions: Standardization and implementation of a finishing protocol contributed to improve clinical performance in the Orthodontics graduate program, as expressed by occlusal outcomes. Greater emphasis should be given on the finishing phase to achieve lower scores in the ABO grading system. PMID:27275620

  13. Orthodontic treatment outcomes obtained by application of a finishing protocol

    Directory of Open Access Journals (Sweden)

    Alvaro Carvajal-Flórez

    2016-04-01

    Full Text Available ABSTRACT Objective: To evaluate the results of a finishing protocol implemented in patients treated in the Orthodontics graduate program at Universidad de Antioquia. Evaluation was carried out by means of the criteria set by the Objective Grading System (OGS of the American Board of Orthodontics (ABO. Methods: Cast models and panoramic radiographs of 34 patients were evaluated. The intervention group (IG consisted of 17 patients (19.88 ± 4.4 years old treated under a finishing protocol. This protocol included training in finishing, application of a finishing guide, brackets repositioning and patient's follow-up. Results of the IG were compared to a control group of 17 patients (21.88 ± 7.0 years old selected by stratified randomization without finishing intervention (CG. Results: The scores for both CG and IG were 38.00 ± 9.0 and 31.41 ± 9.6 (p = 0.048, respectively. The score improved significantly in the IG group, mainly regarding marginal ridges (CG: 5.59 ± 2.2; IG: 3.65 ± 1.8 (p = 0.009 and root angulation (CG: 7.59 ± 2.8; IG: 4.88 ± 2.6 (p = 0.007. Criteria that did not improve, but had the highest scores were: alignment (CG: 6.35 ± 2.7; IG: 6.82 ± 2.8 (p = 0.62 and buccolingual inclination (CG: 3.6 ± 5.88; IG: 5.29 ± 3.9 (p = 0.65. Conclusions: Standardization and implementation of a finishing protocol contributed to improve clinical performance in the Orthodontics graduate program, as expressed by occlusal outcomes. Greater emphasis should be given on the finishing phase to achieve lower scores in the ABO grading system.

  14. Protocol for ADDITION-PRO

    DEFF Research Database (Denmark)

    Johansen, Nanna Borup; Hansen, Anne-Louise Smidt; Jensen, Troels M;

    2012-01-01

    disease and microvascular diabetic complications. We also require a better understanding of the mechanisms that underlie and drive early changes in cardiometabolic physiology. The ADDITION-PRO study was designed to address these issues among individuals at different levels of diabetes risk recruited from...... and metabolic risk factors; (iii) objective measurement of physical activity behaviour; and (iv) long-term follow-up of hard clinical outcomes including mortality and cardiovascular disease. Results will inform policy recommendations concerning cardiovascular risk reduction and treatment among individuals...

  15. Comparison of on Demand Routing Protocols

    Directory of Open Access Journals (Sweden)

    Bharat Bhushan

    2013-02-01

    Full Text Available A routing protocol is used to facilitate communication in ad hoc network. The primary goal of such a routing protocol is to provide an efficient and reliable path between a pair of nodes. The routing protocols for ad hoc network can be categorized into three categories: table driven, on demand and hybrid routing. The table driven and hybrid routing strategies require periodic exchange of hello messages between nodes of the ad hoc network and thus have high processing and bandwidth requirements. On the other hand on demand routing strategy creates routes when required and hence is very much suitable for ad hoc network. This paper therefore examines the performance of three on demand routing protocols at application layer using QualNet-5.01 simulator.

  16. Implementation of the Additional Protocol in Japan

    International Nuclear Information System (INIS)

    The Additional Protocol between Japan and the IAEA entered into force in December 1999. To come into force a series of implementation trials of Additional Protocol was carried out at two Japanese representative nuclear research centers, i.e. Tokai Research Establishment of Japan Atomic Energy Research Institute (JAERI) and Oarai Engineering Center of Japan Nuclear Fuel Cycle Development Institute (JNC). These trials were proposed by Japan and were conducted in cooperation with the IAEA Secretariat. In addition, Japan amended 'the Law for the Regulation of Reactors etc.', to collect adequate information to submit to the IAEA, to arrange the surrounding for the complementary access, etc. In addition, Japan Submitted the Initial Declaration of the Additional Protocol within 180 days of the entry into force of the Protocol, in the middle of June, 2000

  17. Saudi Arabia and CERN sign protocol

    CERN Multimedia

    2008-01-01

    On 9 May 2008, Mohammed I. Al Suwaiyel, President of the King Abdulaziz City of Science and Technology, representing the Government of Saudi Arabia, and CERN Director-General, Robert Aymar, signed a protocol to the 2006 cooperation agreement between CERN and Saudi Arabia. Members of the Saudi Arabian Government visit ATLAS.The purpose of the protocol is to define the operational framework needed to carry out various specific tasks provided for in the cooperation agreement in order to promote the development of a high energy particle physics community in Saudi Arabia and its ultimate visible participation as a member of the global CERN community. Signing the protocol, Mohammed I. Al-Suwaiyel said: "The Saudi Arabian Government has taken a number of initiatives to promote R&D in the interests of our country’s development and the advancement of science. Thanks to this protocol, Saudi scientists will be able to work towards this go...

  18. Standardized North American Marsh Bird Monitoring Protocol

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This document describes monitoring protocols for marshbirds in North America. Monitoring parameters, field procedures, survey methods, timing of surveys, recording...

  19. Privacy-Preserving Protocols for Eigenvector Computation

    CERN Document Server

    Pathak, Manas A

    2010-01-01

    In this paper, we present a protocol for computing the dominant eigenvector of a collection of private data distributed across multiple parties, with the individual parties unwilling to share their data. Our proposed protocol is based on secure multiparty computation with a trusted third-party arbitrator who deals with data encrypted by the other parties using an additive homomorphic cryptosystem. We also augment the protocol with randomization to make it difficult, with a high probability, for any party to estimate properties of the data belonging to other parties from the intermediate steps. The previous approaches towards this problem were based on expensive QR decomposition of correlation matrices, we present an efficient algorithm using the power iteration method. We present an analysis of the correctness, security, efficiency of protocol and experiments over a prototype implementation.

  20. Multicast Routing Protocols in Adhoc Mobile networks

    Directory of Open Access Journals (Sweden)

    S.Nagaprasad,

    2010-11-01

    Full Text Available The majority of applications are in areas where rapid deployment and dynamic reconfiguration are necessary and a wire line network is not available. These include military battlefields, emergency search and rescue sites, classrooms, and conventions where participants share information dynamically using their mobile devices. Well established routing protocols do exist to offer efficient multicasting service in conventional wired networks. These protocols, having been designed for fixed networks, may fails to keep up with node movements and frequent topology changes in a MANET. Therefore, adapting existing wired multicast protocols as such to a MANET, which completely lacks infrastructure, appear less promising. Providing efficient multicasting over MANET faces many challenges, includes scalability,quality of service, reliable service, security, Address configuration, Applications for multicast over MANET. The existing multicast routing protocol do not addresses these issues effectively over Mobile Adhoc Networks (MANET.