WorldWideScience

Sample records for clinical protocols

  1. Protocol Writing in Clinical Research

    Science.gov (United States)

    Al-Jundi, Azzam

    2016-01-01

    Writing a research proposal is probably one of the most challenging and difficult task as research is a new area for the majority of postgraduates and new researchers. The purpose of this article is to summarize the most important steps and necessary guidelines for producing a standard research protocol. Academic and administrative success of any project is usually determined by acquiring a grant for the related field of research. Hence, the quality of a protocol is primarily required to achieve success in this scientific competition. PMID:28050522

  2. Clinical guidelines, clinical pathways and protocols of care

    OpenAIRE

    Angélica Román

    2012-01-01

    The article points out that the importance of standardization of clinical practices has been established in clinical management, which helps solve the problems of variability by developing documents based on the available scientific evidence. The article claims that healthcare culture has increasingly recognized the importance of standardization of clinical practices and provides a conceptual difference between clinical practice guidelines, protocols and algorithms. Clinical pathways and clin...

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

    OpenAIRE

    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

    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...

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

    Science.gov (United States)

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

    2016-04-01

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

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

    Directory of Open Access Journals (Sweden)

    Migdacelys Arboláez Estrada.

    2007-04-01

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

  6. Protocol-writing support conferences for investigator-initiated clinical trials

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    Goto M

    2016-04-01

    Full Text Available Masaya Goto,1 Yoshihiro Muragaki,2 Atsushi Aruga1 1Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women's Medical University and Waseda University, 2Intelligent Clinical Research and Innovation Center, Tokyo Women's Medical University, Tokyo, Japan Abstract: In investigator-initiated clinical trials, protocols with inappropriate methods might cause bias. However, insufficient data are available to determine which items are important or difficult to discuss in protocol development. We recorded protocol-writing support conferences to determine what items methodologists and investigators discussed. We obtained approval from all applicants to attend our Intelligent Clinical Research and Innovation Center writing support conferences, recorded all the discussions, characterized them, and sorted the items iteratively. In 1 year, we had 18 conferences: nine early protocol conferences and nine rejected protocol conferences. The latter were rejected by the institutional review board, which requested consultation. The most discussed item was outcomes, accounting for ~20% of the total discussion time. In three trials, the main problem was multiple primary outcomes. The second most discussed item was control. Early protocol conferences had more non-preliminary proposal items than rejected ones (P<0.001. This study showed important items (especially outcomes and control for investigators to write protocols. Early protocol-writing conferences helped investigators find questionable items. Keywords: investigator-initiated clinical trials, support, protocol-writing, conferences, recording

  7. Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis

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    Ali Ather

    2012-10-01

    Full Text Available Abstract Background Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials. Methods The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists’ clinical judgment and maintaining consistency with a prior pilot study. Results The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated. Conclusions The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings. Trial registration Clinicaltrials.gov NCT00970008 (18 August 2009

  8. Serial extraction protocol for partial arches in implant dentistry: principles and clinical methodology.

    Science.gov (United States)

    Cavallaro, John S; Greenstein, Gary; Greenstein, Ben

    2010-01-01

    Serial extraction protocol (SEP) is a clinical technique that facilitates using natural tooth abutments to support a fixed interim resin prosthesis, while inserting a sufficient number of implants to retain a definitive fixed prosthesis. A Class 1 protocol allows all necessary implants to be placed during one surgical appointment, while a Class 2 protocol requires two or more rounds of implant installation to achieve sufficient support for a definitive fixed prosthesis. The SEP methodology can be used to restore full and partially edentulous dentitions. This article addresses rehabilitation of partial arches using an SEP protocol.

  9. Evaluation of two clinical protocols for the management of women with vaginal discharge in southern Thailand

    OpenAIRE

    Chandeying, V; Skov, S.; Kemapunmanus, M.; Law, M; Geater, A.; P. Rowe

    1998-01-01

    OBJECTIVES: (1) To compare the effectiveness of two clinical protocols for the management of vaginal discharge in the situations where no laboratory facilities are available but speculum examination is possible and where basic laboratory facilities are available. (2) To determine clinical and simple laboratory indicators for diagnosis of patients with vaginal discharge in the local setting. DESIGN: Alternate allocation of subjects to one of two management protocols. SUBJECTS: Women pres...

  10. Clinical exam protocol for the equine thoracolumbar spine

    OpenAIRE

    da Fonseca, Brunna Patricia Almeida; Alves, Ana Liz Garcia [UNESP; Hussni, Carlos Alberto

    2011-01-01

    Thoracolumbar injuries represent a challenge to the veterinarian that seeks to eliminate the pain, reinstitute the athletic use of the horse and minimize economic losses. The percentage of lost training days due to orthopedic conditions in race horses is of 72.1% and within those conditions is back pain, whicht represents from 4.35% to 20% of the lameness cases. The present study searched to establish a protocol based on score points for the thoracolumbar physical exam, by which it is able to...

  11. 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.

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

    Science.gov (United States)

    Ng, Kim-Gau

    2013-10-01

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

  13. 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

  14. 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.

  15. 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

  16. 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.

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

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    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.

  18. Diffusion weighted magnetic resonance imaging of the breast: protocol optimization, interpretation, and clinical applications.

    Science.gov (United States)

    Partridge, Savannah C; McDonald, Elizabeth S

    2013-08-01

    Diffusion-weighted magnetic resonance (MR) imaging (DWI) has shown promise for improving the positive predictive value of breast MR imaging for detection of breast cancer, evaluating tumor response to neoadjuvant chemotherapy, and as a noncontrast alternative to MR imaging in screening for breast cancer. However, data quality varies widely. Before implementing DWI into clinical practice, one must understand the pertinent technical considerations and current evidence regarding clinical applications of breast DWI. This article provides an overview of basic principles of DWI, optimization of breast DWI protocols, imaging features of benign and malignant breast lesions, promising clinical applications, and potential future directions.

  19. 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

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

    Directory of Open Access Journals (Sweden)

    Gereon Berschin

    2014-09-01

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

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

    DEFF Research Database (Denmark)

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

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

    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

  3. 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.

  4. 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.

  5. 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

    2013-10-21

    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

  6. Algorithm of clinical protocol lowering the risk of systemic Mycosis infections in allografts recipients.

    Science.gov (United States)

    Swoboda-Kopec, E; Netsvyetayeva, I; Paczek, L; Dabkowska, M; Kwiatkowski, A; Jaworska-Zaremba, M; Mierzwinska-Nastalska, E; Sikora, M; Blachnio, S; Mlynarczyk, G; Fiedor, P

    2009-10-01

    The aim of the study was to describe a diagnostic protocol to lower the risk of a mycotic invasive infection among allotransplant recipients and to suggest the use of preoperative prophylaxis and/or empiric therapy. We chose a group of 268 allograft recipients with transient or constant yeast colonization or confirmed yeast infection. Among 7744 clinical samples, 475 were positive for fungi. We used conventional fungal laboratory diagnosis, enzymatic activity tests, serologic tests, molecular diagnosis of samples from sterile body sites, and histopathologic examinations. The following clinical samples were examined: blood samples; swabs from mouth lesions, throat, and rectum; and sputum, urine, and fecal samples from kidney transplant recipients and simultaneous pancreas-kidney transplantation recipients who are highly predisposed to mycotic infections. We established microbiologic criteria of a systemic mycosis and principles to distinguish colonization from infection.

  7. 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.

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

    Directory of Open Access Journals (Sweden)

    H Madry

    2014-05-01

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

  9. Clinical examination protocol to detect atypical and classical scrapie in sheep.

    Science.gov (United States)

    Konold, Timm; Phelan, Laura

    2014-01-19

    The diagnosis of scrapie, a transmissible spongiform encephalopathy (TSEs) of sheep and goats, is currently based on the detection of disease-associated prion protein by post mortem tests. Unless a random sample of the sheep or goat population is actively monitored for scrapie, identification of scrapie cases relies on the reporting of clinical suspects, which is dependent on the individual's familiarization with the disease and ability to recognize clinical signs associated with scrapie. Scrapie may not be considered in the differential diagnosis of neurological diseases in small ruminants, particularly in countries with low scrapie prevalence, or not recognized if it presents as nonpruritic form like atypical scrapie. To aid in the identification of clinical suspects, a short examination protocol is presented to assess the display of specific clinical signs associated with pruritic and nonpruritic forms of TSEs in sheep, which could also be applied to goats. This includes assessment of behavior, vision (by testing of the menace response), pruritus (by testing the response to scratching), and movement (with and without blindfolding). This may lead to a more detailed neurologic examination of reporting animals as scrapie suspects. It could also be used in experimental TSE studies of sheep or goats to evaluate disease progression or to identify clinical end-point.

  10. 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

  11. 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

  12. 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

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

    DEFF Research Database (Denmark)

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

    2015-01-01

    was developed in collaboration with the patient and the family. Patients' height and weight were measured at subsequent visits. There were no exclusion criteria. RESULTS: Three-hundred-thirteen (141 boys) were seen in the clinic in the period of February 2010 to March 2013. At inclusion, the median age......, the mean BMI SDS difference was -0.40 (95% CI: -0.56; -0.25, p intervention 120 patients stopped treatment. Retention rates were 0.76 (95% CI: 0.71; 0.81) after one year and 0.57 (95% CI: 0.51; 0.63) after two years...

  14. A feasible repetitive transcranial magnetic stimulation clinical protocol in migraine prevention

    Directory of Open Access Journals (Sweden)

    Shawn Zardouz

    2016-10-01

    Full Text Available Objective: This case series was conducted to determine the clinical feasibility of a repetitive transcranial magnetic stimulation protocol for the prevention of migraine (with and without aura. Methods: Five patients with migraines underwent five repetitive transcranial magnetic stimulation sessions separated in 1- to 2-week intervals for a period of 2 months at a single tertiary medical center. Repetitive transcranial magnetic stimulation was applied to the left motor cortex with 2000 pulses (20 trains with 1s inter-train interval delivered per session, at a frequency of 10 Hz and 80% resting motor threshold. Pre- and post-treatment numerical rating pain scales were collected, and percent reductions in intensity, frequency, and duration were generated. Results: An average decrease in 37.8%, 32.1%, and 31.2% were noted in the intensity, frequency, and duration of migraines post-repetitive transcranial magnetic stimulation, respectively. A mean decrease in 1.9±1.0 (numerical rating pain scale ± standard deviation; range: 0.4–2.8 in headache intensity scores was noted after the repetitive transcranial magnetic stimulation sessions. Conclusion: The tested repetitive transcranial magnetic stimulation protocol is a well-tolerated, safe, and effective method for migraine prevention.

  15. "Absolute" quantification in magnetic resonance spectroscopy: validation of a clinical protocol in multiple sclerosis.

    Science.gov (United States)

    Bagory, Matthieu; Durand-Dubief, Françoise; Ibarrola, Danielle; Confavreux, Christian; Sappey-Marinier, Dominique

    2007-01-01

    MRS allows to measure cerebral metabolites, thus helping to characterize brain disease diagnosis and followup. Metabolite concentration quantification is usually based on metabolite ratio referring to creatine. If this metabolite concentration is supposed to be constant, it may vary in pathological processes. Therefore, "absolute" concentration methodology is needed. The aim of this study is to validate a clinical "absolute" quantification protocol through the development of an external metabolic phantom, calibration and correction, and the investigation of reproducibility issues. When phantom stability was investigated by a short-term and a long-term reproducibility study, both Standard Deviations (SD) were in agreement with literature values. This "absolute" quantification method was applied to patients with Multiple Sclerosis (MS). The results show a significant decrease in both N-Acetyl Aspartate (NAA) and choline concentrations.

  16. Automation of sample preparation for mass cytometry barcoding in support of clinical research: protocol optimization.

    Science.gov (United States)

    Nassar, Ala F; Wisnewski, Adam V; Raddassi, Khadir

    2017-03-01

    Analysis of multiplexed assays is highly important for clinical diagnostics and other analytical applications. Mass cytometry enables multi-dimensional, single-cell analysis of cell type and state. In mass cytometry, the rare earth metals used as reporters on antibodies allow determination of marker expression in individual cells. Barcode-based bioassays for CyTOF are able to encode and decode for different experimental conditions or samples within the same experiment, facilitating progress in producing straightforward and consistent results. Herein, an integrated protocol for automated sample preparation for barcoding used in conjunction with mass cytometry for clinical bioanalysis samples is described; we offer results of our work with barcoding protocol optimization. In addition, we present some points to be considered in order to minimize the variability of quantitative mass cytometry measurements. For example, we discuss the importance of having multiple populations during titration of the antibodies and effect of storage and shipping of labelled samples on the stability of staining for purposes of CyTOF analysis. Data quality is not affected when labelled samples are stored either frozen or at 4 °C and used within 10 days; we observed that cell loss is greater if cells are washed with deionized water prior to shipment or are shipped in lower concentration. Once the labelled samples for CyTOF are suspended in deionized water, the analysis should be performed expeditiously, preferably within the first hour. Damage can be minimized if the cells are resuspended in phosphate-buffered saline (PBS) rather than deionized water while waiting for data acquisition.

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

    Science.gov (United States)

    Trevisan, Margarete Diprat; Lopes, Diene Gomes Colvara; de Mello, Renato Gorga Bandeira; Macagnan, Fabrício Edler; Kessler, Adriana

    2015-01-01

    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 (312.2 vs. 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. PMID:26934400

  18. [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.

  19. 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

  20. 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.

  1. 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.)

  2. A quality control program within a clinical trial Consortium for PCR protocols to detect Plasmodium species.

    Science.gov (United States)

    Taylor, Steve M; Mayor, Alfredo; Mombo-Ngoma, Ghyslain; Kenguele, Hilaire M; Ouédraogo, Smaïla; Ndam, Nicaise Tuikue; Mkali, Happy; Mwangoka, Grace; Valecha, Neena; Singh, Jai Prakash Narayan; Clark, Martha A; Verweij, Jaco J; Adegnika, Ayola Akim; Severini, Carlo; Menegon, Michela; Macete, Eusebio; Menendez, Clara; Cisteró, Pau; Njie, Fanta; Affara, Muna; Otieno, Kephas; Kariuki, Simon; ter Kuile, Feiko O; Meshnick, Steven R

    2014-06-01

    Malaria parasite infections that are only detectable by molecular methods are highly prevalent and represent a potential transmission reservoir. The methods used to detect these infections are not standardized, and their operating characteristics are often unknown. We designed a proficiency panel of Plasmodium spp. in order to compare the accuracy of parasite detection of molecular protocols used by labs in a clinical trial consortium. Ten dried blood spots (DBSs) were assembled that contained P. falciparum, P. vivax, P. malariae, and P. ovale; DBSs contained either a single species or a species mixed with P. falciparum. DBS panels were tested in 9 participating laboratories in a masked fashion. Of 90 tests, 68 (75.6%) were correct; there were 20 false-negative results and 2 false positives. The detection rate was 77.8% (49/63) for P. falciparum, 91.7% (11/12) for P. vivax, 83.3% (10/12) for P. malariae, and 70% (7/10) for P. ovale. Most false-negative P. falciparum results were from samples with an estimated ≤ 5 parasites per μl of blood. Between labs, accuracy ranged from 100% to 50%. In one lab, the inability to detect species in mixed-species infections prompted a redesign and improvement of the assay. Most PCR-based protocols were able to detect P. falciparum and P. vivax at higher densities, but these assays may not reliably detect parasites in samples with low P. falciparum densities. Accordingly, formal quality assurance for PCR should be employed whenever this method is used for diagnosis or surveillance. Such efforts will be important if PCR is to be widely employed to assist malaria elimination efforts.

  3. '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.

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

    Science.gov (United States)

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

    2004-01-01

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

  5. 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

  6. 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

  7. Chronic hand eczema - self-management and prognosis: a study protocol for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Mollerup Annette

    2012-06-01

    Full Text Available Abstract Background Hand eczema has a one-year prevalence of approximately 10 % in the general Danish population. Often the disease becomes chronic with numerous implications for the individual’s daily life, occupation and quality of life. However, no guidelines of self-management recommendations beyond the acute stage are given. Self-management of the disease is pivotal and involves self-monitoring of the condition, medication adherence, and preventive behaviour. Interventions best to support the individual in this ongoing process need to be developed. Methods/design This paper describes the design of a randomised clinical trial to test a newly developed intervention of individual counselling versus conventional information. 300 patients consecutively referred to dermatologic treatment at two different settings are individually randomised to either the intervention programme, named ‘The Healthy Skin Clinic’ or to the control group. Block-wise randomisation according to setting and gender is carried out. The intervention offers a tool for self-monitoring; basic and specific individual counselling; the possibility of asynchronous communication with the intervention team; and an electronic patient dialogue forum. Primary outcome variable is objective assessment of the hand eczema severity performed at baseline prior to randomisation, and repeated at six months follow-up. Secondary outcome variables are dermatology related life quality and perceived global burden of disease. Discussion The trial aims at evaluating a newly developed guidance programme which is expected to support self-management of patients referred to dermatology treatment due to chronic hand eczema. The design of the protocol is pragmatic with blinding of neither participants nor the investigator. Thus, in the interpretation of the results, the investigator takes into account effects that may be attributed to actors of the interventions rather than the intervention per se as

  8. Analysis Treatment Guideline versus Clinical Practice Protocol in Patients Hospitalized due to Heart Failure

    Directory of Open Access Journals (Sweden)

    Alessandra da Graça Corrêa

    2016-01-01

    Full Text Available Background: Despite the availability of guidelines for treatment of heart failure (HF, only a few studies have assessed how hospitals adhere to the recommended therapies. Objectives: Compare the rates of adherence to the prescription of angiotensin-converting enzyme inhibitor or angiotensin II receptor blockers (ACEI/ARB at hospital discharge, which is considered a quality indicator by the Joint Commission International, and to the prescription of beta-blockers at hospital discharge, which is recommended by national and international guidelines, in a hospital with a case management program to supervise the implementation of a clinical practice protocol (HCP and another hospital that follows treatment guidelines (HCG. Methods: Prospective observational study that evaluated patients consecutively admitted to both hospitals due to decompensated HF between August 1st, 2006, and December 31st, 2008. We used as comparing parameters the prescription rates of beta-blockers and ACEI/ARB at hospital discharge and in-hospital mortality. Results: We analyzed 1,052 patients (30% female, mean age 70.6 ± 14.1 years, 381 (36% of whom were seen at HCG and 781 (64% at HCP. The prescription rates of beta-blockers at discharge at HCG and HCP were both 69% (p = 0.458, whereas those of ACEI/ARB were 83% and 86%, respectively (p = 0.162. In-hospital mortality rates were 16.5% at HCP and 27.8% at HCG (p < 0.001. Conclusion: There was no difference in prescription rates of beta-blocker and ACEI/ARB at hospital discharge between the institutions, but HCP had lower in-hospital mortality. This difference in mortality may be attributed to different clinical characteristics of the patients in both hospitals.

  9. 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...... resuscitation is started either pre-hospital or after hospital admission by using transfusion packages with pre-fixed universal blood product combinations and ratios following the concept of "damage control resuscitation" at which applied ratios substantially vary. Two centres initially start with transfusion...

  10. Human Y chromosome microdeletion analysis by PCR multiplex protocols identifying only clinically relevant AZF microdeletions.

    Science.gov (United States)

    Vogt, Peter H; Bender, Ulrike

    2013-01-01

    PCR multiplex assays are the method of choice for quickly revealing genomic microdeletions in the large repetitive genomic sequence blocks on the long arm of the human Y chromosome. They harbor the Azoospermia Factor (AZF) genes, which cause male infertility when functionally disrupted. These protein encoding Y genes are expressed exclusively or predominantly during male germ cell development, i.e., at different phases of human spermatogenesis. They are located in three distinct genomic sequence regions designated AZFa, AZFb, and AZFc, respectively. Complete deletion of an AZF region, also called "classical" AZF microdeletion, is always associated with male infertility and a distinct testicular pathology. Partial AZF deletions including single AZF Y genes can cause the same testicular pathology as the corresponding complete deletion (e.g., DDX3Y gene deletions in AZFa), or might not be associated with male infertility at all (e.g., some BPY2, CDY1, DAZ gene deletions in AZFc). We therefore propose that a PCR multiplex assay aimed to reduce only those AZF microdeletions causing a specific testicular pathology-thus relevant for clinical applications. It only includes Sequence Tagged Site (STS) deletion markers inside the exon structures of the Y genes known to be expressed in male germ cells and located in the three AZF regions. They were integrated in a robust standard protocol for four PCR multiplex mixtures which also include the basic principles of quality control according to the strict guidelines of the European Molecular Genetics Quality Network (EMQN: http://www.emqn.org). In case all Y genes of one AZF region are deleted the molecular extension of this AZF microdeletion is diagnosed to be yes or no comparable to that of the "classical" AZF microdeletion by an additional PCR multiplex assay analyzing the putative AZF breakpoint borderlines.

  11. 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.

  12. 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.

  13. Development of a standardized protocol for reproducible generation of matured monocyte-derived dendritic cells suitable for clinical application

    OpenAIRE

    Bohnenkamp, H.R.; Noll, T.

    2003-01-01

    There is increasing interest in the generation of dendritic cells (DC) for cancer immunotherapy. In order to utilize DC in clinical trials it is necessary to have standardized, reproducible and easy to use protocols. We describe here the process development for the generation of DC as the result of investigation of culture conditions as well as consumption rates of medium and cytokines. Our studies demonstrate that highly viable DC (93 ± 2%) can be produced from CD14+ enriched monocytes via i...

  14. 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.

  15. 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

    group were more severe. None of this was stated in the CSR or in the published paper. Our analysis was restricted to one drug tested in the mid-1990s; our results might therefore not be applicable for newer drugs. CONCLUSIONS: In the orlistat trials, we identified important disparities in the reporting...... 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...

  16. Implementing a clinical assessment protocol for sensory and skeletal function in diabetic neuropathy patients at a university hospital in Brazil

    Directory of Open Access Journals (Sweden)

    Isabel de Camargo Neves Sacco

    Full Text Available CONTEXT AND OBJECTIVE: Physiotherapy can contribute towards recovering or preventing physical and sensory alterations in diabetic neuropathy patients. Our objective was to create and apply a protocol for functional assessment of diabetic neuropathy patients' lower limbs, to guide future physiotherapy. DESIGN AND SETTING: Clinical study at the University Hospital and teaching/research center of Universidade de São Paulo. METHODS: An intentional sample of diabetic neuropathy patients was utilized. The protocol was divided into: (1 preliminary investigation with identification of relevant clinical diabetes and neuropathy characteristics; (2 thermal, tactile and proprioceptive sensitivity tests on the feet; (3 evaluations of muscle function, range of motion, lower limb function, foot anthropometry. RESULTS: The patients' mean age was 57 years, and they had had the diagnosis for 13 years on average. Distal numbness and tingling/prickling were present in 62% and 67%, respectively. There were tactile sensitivity alterations above the heel in 50%, with thermal sensitivity in 40% to 60%. The worst muscle function test responses were at the triceps surae and foot intrinsic muscles. Longitudinal plantar arches were lowered in 50%. Decreased thermal and tactile sensitivity of the heels was found. There was a general reduction in range of motion. CONCLUSIONS: The results provided detailed characterization of the patients. This protocol may be easily applied in healthcare services, since it requires little equipment, at low cost, and it is well understood by patients.

  17. 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.

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

    DEFF Research Database (Denmark)

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

    2014-01-01

    BACKGROUND AIMS: The high level of complexity of current Good Manufacturing Practice-compliant methods of manufacturing hampers rapid and broad application of treatment with tumor-infiltrating lymphocytes (TILs). METHODS: To ensure higher applicability of TIL production to laboratory routine......, a practical and simple protocol of TIL manufacturing with the use of a closed-system bioreactor was developed and implemented at our institution. RESULTS: This protocol enabled significant work load reduction during the most labor-intense step of TIL expansion, and allowed generation of high-quality TIL...... products, which mediated clinical regression in patients with metastatic melanoma. CONCLUSIONS: Implementation of simplified methods of TIL expansion will speed up dissemination of TIL methods worldwide and will increase patient access to this highly effective treatment....

  19. 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.)

  20. Design of a Medical Triage Evidence-Based Clinical Management Protocol and Implementation of Medical Triage On-Line Training for Use by Mission of Mercy Volunteers.

    Science.gov (United States)

    Allen, Kimberly D; DiBartolo, Mary C; Welsh, Debra L; Brown, Voncelia

    2015-01-01

    Evidence-based protocols in safety net settings can help standardize care practices, increase organizational workflow, and enhance quality outcomes for those receiving services. The purpose of this quality improvement project is two-fold: to design an evidence-based medical triage clinical management protocol, and, to influence adherence to that protocol by safety net medical triage volunteers through an on-line volunteer orientation. Leadership skills were required to help translate evidence-based practice recommendations into useful tools to assist in directing practice. Project outcomes included successful multidisciplinary practice change, significantly improved volunteer knowledge surrounding medical triage protocol parameters, increased organizational workflow, and enhanced quality client outcomes.

  1. 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

  2. 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.

  3. A protocol for clinical evaluation of the carrying angle of the elbow by anatomic landmarks.

    Science.gov (United States)

    Zampagni, Maria Luisa; Casino, Daniela; Martelli, Sandra; Visani, Andrea; Marcacci, Maurilio

    2008-01-01

    The aim of this work was to present an in vivo protocol to estimate the carrying angle of the elbow in full extension. Forty-four arms were measured by using an electrogoniometer to acquire 3-dimensional coordinates of the landmarks. An algorithm based on the Cardan decomposition method was used to compute the carrying angle and the flexion and pronation angles of the elbow. The mean carrying angle was 12.42 degrees +/- 4.06 degrees , in agreement with the literature and with values obtained by a standard goniometer (r = 0.46; P = .000). Our protocol provided excellent repeatability (interclass correlation coefficient [ICC] = 0.85), greater than a goniometer (ICC = 0.76), and a standard error of measurement of only 1.62 degrees . Flexion was a significant factor (P = .01) in carrying angle estimation. This study suggests that the carrying angle cannot be estimated independently by the flexion angle, even when measured in apparently full extension, and it could be useful in elbow disorders, such as fractures or epicondylar disease management and evaluation of elbow reconstruction.

  4. Acupuncture in Patients with a Vertebral Compression Fracture: A Protocol for a Randomized, Controlled, Pilot Clinical Trial

    Directory of Open Access Journals (Sweden)

    Hyun-jong Lee

    2015-03-01

    Full Text Available Objectives: A vertebral compression fracture (VCF is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. Methods: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total. The primary outcomes will be the pain intensity (visual analogue scale and PainVisionTM system. The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article

  5. Consensus recommendations for a standardized Brain Tumor Imaging Protocol in clinical trials

    NARCIS (Netherlands)

    B.M. Ellingson (Benjamin M.); M. Bendszus (Martin); J. Boxerman (Jerrold); D. Barboriak (Daniel); B.J. Erickson (Bradley J.); M. Smits (Marion); S.J. Nelson (Sarah J.); E. Gerstner (Elizabeth); B. Alexander (Brian); G. Goldmacher (Gregory); W. Wick (Wolfgang); M.A. Vogelbaum (Michael); M. Weller (Michael); E. Galanis (Evanthia); J. Kalpathy-Cramer (Jayashree); L. Shankar; P. Jacobs (Paula); W.B. Pope (Whitney B.); D. Yang (Dewen); C. Chung (Caroline); R.H. Knopp; S. Cha (Soonme); M.J. van den Bent (Martin); S.M. Chang (Susan); W.K. Al Yung; T.F. Cloughesy (Timothy F.); P.Y. Wen (Patrick Y.); M.R. Gilbert (Mark R.); A. Whitney (Andrew); D. Sandak (David); A. Musella (Al); C. Haynes (Chas); M. Wallace (Max); D.F. Arons (David F.); A. Kingston (Ann)

    2015-01-01

    textabstractA recent joint meeting was held on January 30, 2014, with the US Food and Drug Administration (FDA), National Cancer Institute (NCI), clinical scientists, imaging experts, pharmaceutical and biotech companies, clinical trials cooperative groups, and patient advocate groups to discuss ima

  6. 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

  7. 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.

  8. 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.

  9. Clinical Examination Protocol to Detect Atypical and Classical Scrapie in Sheep

    OpenAIRE

    Konold, Timm; Phelan, Laura

    2014-01-01

    The diagnosis of scrapie, a transmissible spongiform encephalopathy (TSEs) of sheep and goats, is currently based on the detection of disease-associated prion protein by post mortem tests. Unless a random sample of the sheep or goat population is actively monitored for scrapie, identification of scrapie cases relies on the reporting of clinical suspects, which is dependent on the individual's familiarization with the disease and ability to recognize clinical signs associated with scrapie. Scr...

  10. ABM Clinical Protocol #1: Guidelines for Blood Glucose Monitoring and Treatment of Hypoglycemia in Term and Late-Preterm Neonates, Revised 2014

    Science.gov (United States)

    Wight, Nancy

    2014-01-01

    A central goal of The Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient. PMID:24823918

  11. 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.

  12. 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

  13. Development of a standardized protocol for reproducible generation of matured monocyte-derived dendritic cells suitable for clinical application.

    Science.gov (United States)

    Bohnenkamp, H R; Noll, T

    2003-09-01

    There is increasing interest in the generation of dendritic cells (DC) for cancer immunotherapy. In order to utilize DC in clinical trials it is necessary to have standardized, reproducible and easy to use protocols. We describe here the process development for the generation of DC as the result of investigation of culture conditions as well as consumption rates of medium and cytokines. Our studies demonstrate that highly viable DC (93 +/- 2%) can be produced from CD14(+) enriched monocytes via immunomagnetic beads in a high yield (31 +/- 6%) with X-VIVO 15, 400 U ml(-1) GM-CSF and 2000 U ml(-1) IL-4 without serum and feeding. For the maturation of DC different cocktails (TNF-alpha, IL-1beta, IL-6, PGE(2) and TNF-alpha, PGE(2)) were compared. In both cases cells expressed typical surface molecules of mature DC and induced high proliferative responses in mixed lymphocyte reactions which led to IFN-gamma producing T-lymphocytes. The data suggest that the use of this optimized, easy to use protocol results in highly mature DC.

  14. 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

  15. Determining the Optimal Protocol for Measuring an Albuminuria Class Transition in Clinical Trials in Diabetic Kidney Disease

    DEFF Research Database (Denmark)

    Kröpelin, Tobias F; de Zeeuw, Dick; Remuzzi, Giuseppe;

    2016-01-01

    clinical trials testing the effect of renin-angiotensin-aldosterone system intervention on albuminuria class transition in patients with diabetes: the BENEDICT, the DIRECT, the ALTITUDE, and the IRMA-2 Trial. The definition of albuminuria class transition used in each trial differed from the definitions...... used in the other trials by the number (one, two, or three) of consecutively collected urine samples at each study visit, the time interval between study visits, the requirement of an additional visit to confirm the class transition, and the requirement of a percentage increase in albuminuria from......Albuminuria class transition (normo- to micro- to macroalbuminuria) is used as an intermediate end point to assess renoprotective drug efficacy. However, definitions of such class transition vary between trials. To determine the most optimal protocol, we evaluated the approaches used in four...

  16. 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.

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

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    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.

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

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    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.

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

    Directory of Open Access Journals (Sweden)

    Jiae Choi

    2016-08-01

    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.

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

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    Callahan Christopher M

    2012-06-01

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

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

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    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

  2. 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.

  3. Falls and mobility in Parkinson's disease: protocol for a randomised controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Murphy Anna T

    2011-07-01

    Full Text Available Abstract Background Although physical therapy and falls prevention education are argued to reduce falls and disability in people with idiopathic Parkinson's disease, this has not yet been confirmed with a large scale randomised controlled clinical trial. The study will investigate the effects on falls, mobility and quality of life of (i movement strategy training combined with falls prevention education, (ii progressive resistance strength training combined with falls prevention education, (iii a generic life-skills social program (control group. Methods/Design People with idiopathic Parkinson's disease who live at home will be recruited and randomly allocated to one of three groups. Each person shall receive therapy in an out-patient setting in groups of 3-4. Each group shall be scheduled to meet once per week for 2 hours for 8 consecutive weeks. All participants will also have a structured 2 hour home practice program for each week during the 8 week intervention phase. Assessments will occur before therapy, after the 8 week therapy program, and at 3 and 12 months after the intervention. A falls calendar will be kept by each participant for 12 months after outpatient therapy. Consistent with the recommendations of the Prevention of Falls Network Europe group, three falls variables will be used as the primary outcome measures: the number of fallers, the number of multiple fallers and the falls rate. In addition to quantifying falls, we shall measure mobility, activity limitations and quality of life as secondary outcomes. Discussion This study has the potential to determine whether outpatient movement strategy training combined with falls prevention education or progressive resistance strength training combined with falls prevention education are effective for reducing falls and improving mobility and life quality in people with Parkinson's disease who live at home. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR

  4. 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

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

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    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

  6. The treatment of super-refractory status epilepticus: a critical review of available therapies and a clinical treatment protocol.

    Science.gov (United States)

    Shorvon, Simon; Ferlisi, Monica

    2011-10-01

    Super-refractory status epilepticus is defined as status epilepticus that continues or recurs 24 h or more after the onset of anaesthetic therapy, including those cases where status epilepticus recurs on the reduction or withdrawal of anaesthesia. It is an uncommon but important clinical problem with high mortality and morbidity rates. This article reviews the treatment approaches. There are no controlled or randomized studies, and so therapy has to be based on clinical reports and opinion. The published world literature on the following treatments was critically evaluated: anaesthetic agents, anti-epileptic drugs, magnesium infusion, pyridoxine, steroids and immunotherapy, ketogenic diet, hypothermia, emergency resective neurosurgery and multiple subpial transection, transcranial magnetic stimulation, vagal nerve stimulation, deep brain stimulation, electroconvulsive therapy, drainage of the cerebrospinal fluid and other older drug therapies. The importance of treating the identifying cause is stressed. A protocol and flowchart for managing super-refractory status epilepticus is suggested. In view of the small number of published reports, there is an urgent need for the establishment of a database of outcomes of individual therapies.

  7. 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

  8. Development and Evaluation of Evidence-Informed Clinical Nursing Protocols for Remote Assessment, Triage and Support of Cancer Treatment-Induced Symptoms

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    Dawn Stacey

    2013-01-01

    Full Text Available The study objective was to develop and evaluate a template for evidence-informed symptom protocols for use by nurses over the telephone for the assessment, triage, and management of patients experiencing cancer treatment-related symptoms. Guided by the CAN-IMPLEMENT© methodology, symptom protocols were developed by, conducting a systematic review of the literature to identify clinical practice guidelines and systematic reviews, appraising their quality, reaching consensus on the protocol template, and evaluating the two symptom protocols for acceptability and usability. After excluding one guideline due to poor overall quality, the symptom protocols were developed using 12 clinical practice guidelines (8 for diarrhea and 4 for fever. AGREE Instrument (Appraisal of Guidelines for Research and Evaluation rigour domain subscale ratings ranged from 8% to 86% (median 60.1 diarrhea; 40.5 fever. Included guidelines were used to inform the protocols along with the Edmonton Symptom Assessment System questionnaire to assess symptom severity. Acceptability and usability testing of the symptom populated template with 12 practicing oncology nurses revealed high readability (n=12, just the right amount of information (n=10, appropriate terms (n=10, fit with clinical work flow (n=8, and being self-evident for how to complete (n=5. Five nurses made suggestions and 11 rated patient self-management strategies the highest for usefulness. This new template for symptom protocols can be populated with symptom-specific evidence that nurses can use when assessing, triaging, documenting, and guiding patients to manage their-cancer treatment-related symptoms.

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

    Directory of Open Access Journals (Sweden)

    Brad B Swelstad

    2009-12-01

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

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

    Science.gov (United States)

    Swelstad, Brad B; Kerr, Candace L

    2009-12-22

    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.

  11. 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

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

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    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.

  13. 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.

  14. 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.

  15. 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.

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

    Science.gov (United States)

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

    2013-01-01

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

  17. 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

  18. 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

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

    Directory of Open Access Journals (Sweden)

    Renu B. Pattanshetty

    2015-04-01

    Full Text Available 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 to evaluate effect of physiotherapist designed supervised exercise protocol of muscle strength and autonomic parameters in this subject population. Material and Methods: This clinical trial was conducted in thirty (30 adult subjects with type 2 diabetes mellitus including both males and females in the age group of 18 to 65 years. All subjects received physiotherapist designed supervised exercise training protocol consisting of aerobic, resistance & flexibility training. Pre-exercise and post-exercise outcome measurements were taken at baseline, 7th & 14th day in the form of 1-RM for muscle strength and autonomic parameters. Results: Statistical analysis of outcomes at baseline, 7th day and 14th day showed statistically significant difference in strength (p=0.0001, and reduction in autonomic parameters (p=0.0001 Conclusion: The therapist designed exercise protocol has shown to improve muscle strength , mean systolic blood pressure, diastolic blood pressure, pulse rate, pulse pressure, mean arterial pressure, rate pressure product. The protocol has also proved to be safe since no adverse event was noted post exercise.

  20. Data for improvement and clinical excellence: protocol for an audit with feedback intervention in long-term care

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    Schalm Corinne

    2010-10-01

    Full Text Available Abstract Background There is considerable evidence about the effectiveness of audit coupled with feedback, although few audit with feedback interventions have been conducted in long-term care (LTC settings to date. In general, the effects have been found to be modest at best, although in settings where there has been little history of audit and feedback, the effects may be greater, at least initially. The primary purpose of the Data for Improvement and Clinical Excellence (DICE Long-Term Care project is to assess the effects of an audit with feedback intervention delivered monthly over 13 months in four LTC facilities. The research questions we addressed are: 1. What effects do feedback reports have on processes and outcomes over time? 2. How do different provider groups in LTC and home care respond to feedback reports based on data targeted at improving quality of care? Methods/design The research team conducting this study comprises researchers and decision makers in continuing care in the province of Alberta, Canada. The intervention consists of monthly feedback reports in nine LTC units in four facilities in Edmonton, Alberta. Data for the feedback reports comes from the Resident Assessment Instrument Minimum Data Set (RAI version 2.0, a standardized instrument mandated for use in LTC facilities throughout Alberta. Feedback reports consist of one page, front and back, presenting both graphic and textual information. Reports are delivered to all staff working in the four LTC facilities. The primary evaluation uses a controlled interrupted time series design both adjusted and unadjusted for covariates. The concurrent process evaluation uses observation and self-report to assess uptake of the feedback reports. Following the project phase described in this protocol, a similar intervention will be conducted in home care settings in Alberta. Depending on project findings, if they are judged useful by decision makers participating in this research

  1. 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.

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

    Directory of Open Access Journals (Sweden)

    Ilić Nina

    2014-01-01

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

  3. Care planning needs of palliative home care clients: Development of the interRAI palliative care assessment clinical assessment protocols (CAPs)

    OpenAIRE

    Freeman, Shannon; Hirdes, John P; Stolee, Paul; Garcia, John; Smith, Trevor Frise; Steel, Knight; Morris, John N.

    2014-01-01

    Background The interRAI Palliative Care (interRAI PC) assessment instrument provides a standardized, comprehensive means to identify person-specific need and supports clinicians to address important factors such as aspects of function, health, and social support. The interRAI Clinical Assessment Protocols (CAPs) inform clinicians of priority issues requiring further investigation where specific intervention may be warranted and equip clinicians with evidence to better inform development of a ...

  4. 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

  5. A Randomized Trial of Comparing the Efficacy of Two Neurofeedback Protocols for Treatment of Clinical and Cognitive Symptoms of ADHD: Theta Suppression/Beta Enhancement and Theta Suppression/Alpha Enhancement

    Directory of Open Access Journals (Sweden)

    Arash Mohagheghi

    2017-01-01

    Full Text Available Introduction. Neurofeedback (NF is an adjuvant or alternative therapy for children with Attention Deficit Hyperactivity Disorder (ADHD. This study intended to compare the efficacy of two different NF protocols on clinical and cognitive symptoms of ADHD. Materials and Methods. In this clinical trial, sixty children with ADHD aged 7 to 10 years old were randomly grouped to receive two different NF treatments (theta suppression/beta enhancement protocol and theta suppression/alpha enhancement protocol. Clinical and cognitive assessments were conducted prior to and following the treatment and also after an eight-week follow-up. Results. Both protocols alleviated the symptoms of ADHD in general (p<0.001, hyperactivity (p<0.001, inattention (p<0.001, and omission errors (p<0.001; however, they did not affect the oppositional and impulsive scales nor commission errors. These effects were maintained after an eight-week intervention-free period. The only significant difference between the two NF protocols was that high-frequency alpha enhancement protocol performed better in suppressing omission errors (p<0.001. Conclusion. The two NF protocols with theta suppression/beta enhancement and theta suppression/alpha enhancement have considerable and comparable effect on clinical symptoms of ADHD. Alpha enhancement protocol was more effective in suppressing omission errors.

  6. 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

  7. 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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2013-10-01

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

  9. 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

  10. Training professionals' communication and motivation skills to improve spinal cord injury patients' satisfaction and clinical outcomes: Study protocol of the ESPELMA trial.

    Science.gov (United States)

    Lusilla-Palacios, Pilar; Castellano-Tejedor, Carmina; Lucrecia-Ramírez-Garcerán; Navarro-Sanchís, José A; Rodríguez-Urrutia, Amanda; Parramon-Puig, Gemma; Valero-Ventura, Sergi; Cuxart-Fina, Ampar

    2015-10-01

    Acute spinal cord injury leaves patients severely impaired and generates high levels of psychological distress among them and their families, which can cause a less active role in rehabilitation, worse functional recovery, and less perceived satisfaction with the results. Additionally, rehabilitation professionals who deal with this psychological distress could ultimately experience higher stress and more risk of burnout. This article presents the study protocol of the ESPELMA project, aimed to train rehabilitation professionals in the clinical management of acute spinal cord injury-associated psychological distress, and to measure the impact of this training on the patients' perceived satisfaction with treatment.

  11. Comparative evaluation of a chromogenic agar medium-PCR protocol with a conventional method for isolation of Vibrio parahaemolyticus strains from environmental and clinical samples.

    Science.gov (United States)

    Canizalez-Roman, Adrian; Flores-Villaseñor, Héctor; Zazueta-Beltran, Jorge; Muro-Amador, Secundino; León-Sicairos, Nidia

    2011-02-01

    Screening for pathogenic Vibrio parahaemolyticus has become routine in certain areas associated with food-borne outbreaks. This study is an evaluation of the CHROMagar Vibrio (CV) medium-PCR protocol and the conventional method (TCBS (thiosulfate-citrate-bile salts-sucrose) agar plus biochemical and Wagatsuma agar tests) for detection of V. parahaemolyticus in shrimp, water, sediment, and stool samples collected for biosurveillance in an endemic area of northwestern Mexico. A total of 131 environmental and clinical samples were evaluated. The CV medium-PCR protocol showed a significantly improved ability (P TDH) in developing countries. In our results, Wagatsuma agar showed low sensitivity (65.4% at 24 h and 75.6% at 48 h) and specificity (52.4% at 48 h) for identifying V. parahaemolyticus positive for TDH. Overall, our data support the use of the CV medium-PCR protocol in place of the conventional method (TCBS-biochemical tests-Wagatsuma agar) for detection of pathogenic V. parahaemolyticus, both in terms of effectiveness and cost efficiency.

  12. 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.

  13. 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

  14. 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

  15. 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

  16. Impact of an Abbreviated Cardiac Enzyme Protocol to Aid Rapid Discharge of Patients with Cocaine-associated Chest Pain in the Clinical Decision Unit

    Directory of Open Access Journals (Sweden)

    Faheem W. Guirgis

    2014-03-01

    Full Text Available Introduction: In 2007 there were 64,000 visits to the emergency department (ED for possible myocardial infarction (MI related to cocaine use. Prior studies have demonstrated that low- to intermediate-risk patients with cocaine-associated chest pain can be safely discharged after 9-12 hours of observation. The goal of this study was to determine the safety of an 8-hour protocol for ruling out MI in patients who presented with cocaine-associated chest pain. Methods: We conducted a retrospective review of patients treated with an 8-hour cocaine chest pain protocol between May 1, 2011 and November 30, 2012 who were sent to the clinical decision unit (CDU for observation. The protocol included serial cardiac biomarker testing with Troponin-T, CK-MB (including delta CK-MB, and total CK at 0, 2, 4, and 8 hours after presentation with cardiac monitoring for the observation period. Patients were followed up for adverse cardiac events or death within 30 days of discharge. Results: There were 111 admissions to the CDU for cocaine chest pain during the study period. One patient had a delta CK-MB of 1.6 ng/ml, but had negative Troponin-T at all time points. No patient had a positive Troponin-T or CK-MB at 0, 2, 4 or 8 hours, and there were no MIs or deaths within 30 days of discharge. Most patients were discharged home (103 and there were 8 inpatient admissions from the CDU. Of the admitted patients, 2 had additional stress tests that were negative, 1 had additional cardiac biomarkers that were negative, and all 8 patients were discharged home. The estimated risk of missing MI using our protocol is, with 99% confidence, less than 5.1% and with 95% confidence, less than 3.6% (99% CI, 0-5.1%; 95% CI, 0-3.6%. Conclusion: Application of an abbreviated cardiac enzyme protocol resulted in the safe and rapid discharge of patients presenting to the ED with cocaine-associated chest pain. [West J Emerg Med. 2014;15(2:180–183.

  17. 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).

  18. 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.

  19. 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

  20. 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

  1. Designing intervention protocols for nursing clinical trials%护理临床研究中干预方案的制定

    Institute of Scientific and Technical Information of China (English)

    王少玲; 黄金月; 周家仪

    2014-01-01

    Intervention design is a key link in an experimental research and may directly affect the quality and outcomes of care and research. Effective nursing interventions are developed through a systematic and rigorous process. With authors own experience in designing nursing interventions, this article recommends three main steps for developing intervention protocols in nursing clinical trials. They are: ①to establish a conceptual framework for interventions with the regard to the indentiifed research problem;②to develop evidence-based intervention protocols along with careful consideration of the intervention target, delivery methods, intervention property, intervention dose (including components, amount, frequency and duration of nursing care), interventionists and intervention management;③to validate and take pilot test of the protocols before their actual usage in the main study.%干预方案的设计是实验性研究中的一个重要环节,直接影响护理和研究的质量和结局。有效护理干预方案的制定须经历一个严谨的过程。本文借助笔者的设计经验提出护理临床研究中干预方案的制定的三个重要步骤:①围绕研究主题建立干预的概念框架;②建立以循证为基础的干预方案,包含目标群体、实施方法、干预特性、护理剂量(成分、数量、频次和周期)、干预者和干预管理;③实施前对干预方案进行审核和测试。

  2. 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.

  3. 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

  4. 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.

  5. 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

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

    DEFF Research Database (Denmark)

    Szöts, Kirsten; Konradsen, Hanne; Solgaard, Søren

    2014-01-01

    BACKGROUND: Due to shorter hospitalization, patients have to take responsibility for their rehabilitation period at a very early stage. The objective of this trial is to study the effects of two treatment schemes following total knee arthroplasty: conventional treatment following discharge from...... to the orthopaedic outpatient clinic during the rehabilitation period. METHOD/DESIGN: The design is a randomized un-blinded parallel group clinical trial conducted at the Department of Orthopaedic Surgery, Gentofte Hospital, the Capital Region of Denmark. In total, 116 patients will be allocated by an external...... randomization program to 2 groups: an intervention group following usual treatment after discharge supplemented by a nurse managed structured follow-up consultation conducted by telephone 4 and 14 days after discharge from hospital and a control group following treatment as usual. The consultations...

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2009-05-15

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

  8. 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

  9. Comparing single-site with multisite rTMS for the treatment of chronic tinnitus – clinical effects and neuroscientific insights: study protocol for a randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Several years ago, repetitive transcranial magnetic stimulation (rTMS) of the auditory cortex has been introduced as a treatment approach for chronic tinnitus. Even if this treatment is beneficial for a subgroup of patients, the overall effects are limited. This limitation may be due to the fact that the auditory cortex is only one of several brain areas involved in tinnitus. Whereas auditory areas are considered to code for tinnitus loudness, conscious perception of and attention allocation to tinnitus is supposed to be reflected by network activity involving frontal and parietal cortical areas. The aim of the present study is to influence this frontoparietal network more efficiently by perturbing the most important nodes with rTMS. Methods/design This is a randomized, double-blind, parallel-group study. Patients receive rTMS treatment on 10 consecutive working days using either the multisite rTMS protocol (left dorsolateral prefrontal, 1,000 stimuli, 20 Hz; left temporoparietal, 1,000 stimuli, 1 Hz; right temporoparietal stimulation, 1,000 stimuli, 1 Hz) or a single-site protocol (unilateral stimulation of the temporoparietal cortex, 3,000 stimuli, 1 Hz). Individuals aged 18 to 70 years with chronic tinnitus ≥6-month duration and a Tinnitus Handicap Inventory score ≥38 are recruited for the study. A total of 50 patients are needed to detect a clinical relevant change of tinnitus severity (α = 0.05; 1 – β = 0.80). Primary outcome measures are the change in the Tinnitus Questionnaire score from baseline to the end of treatment as well as the number of treatment responders as defined by a reduction in the Tinnitus Questionnaire score of ≥5 points. Furthermore, changes in brain structure and activity are assessed using (functional) magnetic resonance imaging and electroencephalography in the resting state. Those measurements are also performed in 25 healthy control subjects. Discussion This study is designed to reveal whether network

  10. 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

  11. 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.

  12. 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.

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

    Science.gov (United States)

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

    2012-06-01

    It has been often demonstrated that clinicians exhibit both inter-expert and intra-expert variability when making difficult decisions. In contrast, the vast majority of computerized models that aim to provide automated support for such decisions do not explicitly recognize or replicate this variability. Furthermore, the perfect consistency of computerized models is often presented as a de facto benefit. In this paper, we describe a novel approach to incorporate variability within a fuzzy inference system using non-stationary fuzzy sets in order to replicate human variability. We apply our approach to a decision problem concerning the recommendation of post-operative breast cancer treatment; specifically, whether or not to administer chemotherapy based on assessment of five clinical variables: NPI (the Nottingham Prognostic Index), estrogen receptor status, vascular invasion, age and lymph node status. In doing so, we explore whether such explicit modeling of variability provides any performance advantage over a more conventional fuzzy approach, when tested on a set of 1310 unselected cases collected over a fourteen year period at the Nottingham University Hospitals NHS Trust, UK. The experimental results show that the standard fuzzy inference system (that does not model variability) achieves overall agreement to clinical practice around 84.6% (95% CI: 84.1-84.9%), while the non-stationary fuzzy model can significantly increase performance to around 88.1% (95% CI: 88.0-88.2%), p<0.001. We conclude that non-stationary fuzzy models provide a valuable new approach that may be applied to clinical decision support systems in any application domain.

  14. 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

  15. 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

  16. 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.

  17. Organisation and management of the first clinical trial of BNCT in Europe (EORTC protocol 11961).EORTC BNCT study group.

    Science.gov (United States)

    Sauerwein, W; Moss, R; Rassow, J; Stecher-Rasmussen, F; Hideghéty, K; Wolbers, J G; Sack, H

    1999-06-01

    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.

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

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    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

  19. 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

  20. A protocol for generation of clinical grade mRNA-transfected monocyte-derived dendritic cells for cancer vaccines.

    Science.gov (United States)

    Mu, L J; Gaudernack, G; Saebøe-Larssen, S; Hammerstad, H; Tierens, A; Kvalheim, G

    2003-11-01

    With the aim of producing large quantities of mRNA-transfected monocyte-derived dendritic cells (DCs) to be used as cancer vaccines, a new clinical grade procedure has been developed. Peripheral blood mononuclear cells (PBMCs) obtained by leukapheresis were enriched for monocytes by immunomagnetic depletion of CD19+ B cells and CD2+ T cells employing the ISOLEX 300i device. After 5 days of culture of enriched monocytes in gas permeable Teflon bags, using serum-free medium supplemented with granulocyte/macrophage-colony stimulating factor and interleukin-4 (IL-4), immature DCs were generated. Following transfection with mRNA from three human prostate cancer cell lines (DU145, LNCaP and PC-3), employing a newly developed square wave electroporation procedure, the immature DCs were immediately transferred to Teflon bags and matured for 48 h, using serum-free medium supplemented with IL-1alpha, IL-6, tumour necrosis factor-alpha and PGE2. The electroporation procedure efficiently transferred mRNA into the DCs with minor effect on the viability of the cells. The generated matured transfected DCs show high expression of the antigens CD83, CD80, CD86 and human leucocyte antigen-DR. Freezing and thawing of the transfected matured DCs had minor effect on cell viability and the phenotype. From 4 x 109 PBMCs, about 1 x 108 transfected matured DCs are produced. The thawed transfected DCs were able to elicit primary T-cell responses in vitro against antigens encoded by the prostate cancer mRNA as shown by enzyme-linked immunospot assay using mock-transfected DCs as control. Based on these results, clinical trials in cancer patients have been initiated.

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

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    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

  2. De-escalation treatment protocols for human papillomavirus-associated oropharyngeal squamous cell carcinoma: a systematic review and meta-analysis of current clinical trials.

    Science.gov (United States)

    Masterson, Liam; Moualed, Daniel; Liu, Zi Wei; Howard, James E F; Dwivedi, Raghav C; Tysome, James R; Benson, Richard; Sterling, Jane C; Sudhoff, Holger; Jani, Piyush; Goon, Peter K C

    2014-10-01

    Iatrogenic complications associated with current treatment protocols for oropharyngeal squamous cell carcinoma are noted to cause high rates of acute and chronic morbidity. The aims of this study are to provide an overview of the current de-escalation trials for human papillomavirus positive (HPV+) oropharyngeal carcinoma and to evaluate the evidence supporting improved response to treatment of patients within this viral cohort. This study reviewed all completed or in progress randomised controlled trials (RCTs) assessing clinical interventions for human papillomavirus-associated locally advanced oropharyngeal squamous cell carcinoma. We utilised a validated 'risk of bias' tool to assess study quality. We identified nine RCTs that met the full inclusion criteria for this review (all of which are currently on-going and will report from 2015 onwards). Five RCTs performed a post hoc analysis by HPV status, which allowed meta-analysis of 1130 patients. The data reveal a significant difference in overall survival (hazard ratio (HR) 0.49 [95% confidence interval (CI) 0.35-0.69]), loco-regional failure (HR 0.43 [95% CI 0.17-1.11]) and disease specific survival (0.41 [95% 0.3-0.56]) in favour of the HPV+ category. In considering de-escalation treatment protocols, nine studies are currently ongoing. Our meta-analysis provides strong evidence for an improved prognosis in the viral associated cohort when treated by platinum based chemotherapy in combination with radiotherapy or primary radiotherapy. So far, one trial (with moderate to high risk of bias) suggests a reduced survival outcome for the HPV+ population when using the epidermal growth factor receptor (EGFR) inhibitor cetuximab.

  3. Clinical, Radiographic and Microbiological Evaluation of High Level Laser Therapy, a New Photodynamic Therapy Protocol, in Peri-Implantitis Treatment; a Pilot Experience

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    Gianluigi Caccianiga

    2016-01-01

    Full Text Available Aim. Endosseous implants are widely used to replace missing teeth but mucositis and peri-implantitis are the most frequent long-term complications related with dental implants. Removing all bacterial deposits on contaminated implant surface is very difficult due to implant surface morphology. The aim of this study was to evaluate the bactericidal potential of photodynamic therapy by using a new high level laser irradiation protocol associated with hydrogen peroxide in peri-implantitis. Materials and Methods. 10 patients affected by peri-implantitis were selected for this study. Medical history, photographic documentation, periodontal examination, and periapical radiographs were collected at baseline and 6 months after surgery. Microbiological analysis was performed with PCR Real Time. Each patient underwent nonsurgical periodontal therapy and surgery combined with photodynamic therapy according to High Level Laser Therapy protocol. Results. All peri-implant pockets were treated successfully, without having any complication and not showing significant differences in results. All clinical parameters showed an improvement, with a decrease of Plaque Index (average decrease of 65%, range 23–86%, bleeding on probing (average decrease of 66%, range 26–80%, and probing depth (average decrease of 1,6 mm, range 0,46–2,6 mm. Periapical radiographs at 6 months after surgery showed a complete radiographic filling of peri-implant defect around implants treated. Results showed a decrease of total bacterial count and of all bacterial species, except for Eikenella corrodens, 6 months after surgery. Conclusion. Photodynamic therapy using HLLT appears to be a good adjunct to surgical treatment of peri-implantitis.

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

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    Montz, R. [Univ. Complutense, Madrid (Spain); Perez-Castejon, M.J. [Univ. Complutense, Madrid (Spain); Jurado, J.A. [Inst. de Cardiologia, Madrid (Spain); Martin-Comin, J. [Hospital de Bellvitge, Hospitalet de Ll./Barcelona (Spain); Esplugues, E. [Hospital de Bellvitge, Hospitalet de Ll./Barcelona (Spain); Salgado, L. [Hospital de Santa Cruz, Carnaxide (Portugal); Ventosa, A. [Hospital de Santa Cruz, Carnaxide (Portugal); Cantinho, G. [Facultad de Medicina, Hospital Santa Maria, Lisbon (Portugal); Sa, E.P. [Facultad de Medicina, Hospital Santa Maria, Lisbon (Portugal); Fonseca, A.T. [Inst. Portugues de Oncologia (IPOFG), Lisbon (Portugal); Vieira, M.R. [Inst. Portugues de Oncologia (IPOFG), Lisbon (Portugal); Ortiz-Berrocal, J. [Universidad Autonoma de Madrid (Spain). Clinica Puerta de Hierro; Tabuenca, M.J. [Universidad Autonoma de Madrid (Spain). Clinica Puerta de Hierro; Garcia, A. [Hospital Clinico y Provincial, Barcelona (Spain); Magrina, J. [Hospital Clinico y Provincial, Barcelona (Spain); Ortega, D. [Hospital Valle de Hebron, Barcelona (Spain); Puente, C. [Hospital Regional Carlos Haya, Malaga (Spain); Ferrer, A.I. [Hospitals da Universidade, Coimbra (Portugal); Pedrosa, J. [Hospitals da Universidade, Coimbra (Portugal); Latre, J.M. [Hospital Reina Sofia, Cordoba (Spain); Carreras, J.L. [Univ. Complutense, Madrid (Spain)

    1996-06-01

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

  5. 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

  6. Effectiveness of problem gambling interventions in a service setting: a protocol for a pragmatic randomised controlled clinical trial

    Science.gov (United States)

    Abbott, M; Bellringer, M; Vandal, A C; Hodgins, D C; Battersby, M; Rodda, S N

    2017-01-01

    Introduction The primary purpose of this study is to evaluate the relative effectiveness of 2 of the best developed and most promising forms of therapy for problem gambling, namely face-to-face motivational interviewing (MI) combined with a self-instruction booklet (W) and follow-up telephone booster sessions (B; MI+W+B) and face-to-face cognitive–behavioural therapy (CBT). Methods and analysis This project is a single-blind pragmatic randomised clinical trial of 2 interventions, with and without the addition of relapse-prevention text messages. Trial assessments take place pretreatment, at 3 and 12 months. A total of 300 participants will be recruited through a community treatment agency that provides services across New Zealand and randomised to up to 10 face-to-face sessions of CBT or 1 face-to-face session of MI+W+up to 5 B. Participants will also be randomised to 9 months of postcare text messaging. Eligibility criteria include a self-perception of having a current gambling problem and a willingness to participate in all components of the study (eg, read workbook). The statistical analysis will use an intent-to-treat approach. Primary outcome measures are days spent gambling and amount of money spent per day gambling in the prior month. Secondary outcome measures include problem gambling severity, gambling urges, gambling cognitions, mood, alcohol, drug use, tobacco, psychological distress, quality of life, health status and direct and indirect costs associated with treatment. Ethics and dissemination The research methods to be used in this study have been approved by the Ministry of Health, Health and Disability Ethics Committees (HDEC) 15/CEN/99. The investigators will provide annual reports to the HDEC and report any adverse events to this committee. Amendments will also be submitted to this committee. The results of this trial will be submitted for publication in peer-reviewed journals and as a report to the funding body. Additionally, the results

  7. Shock wave therapy associated with eccentric strengthening versus isolated eccentric strengthening for Achilles insertional tendinopathy treatment: a double-blinded randomised clinical trial protocol

    Science.gov (United States)

    Mansur, Nacime Salomão Barbachan; Faloppa, Flávio; Belloti, João Carlos; Ingham, Sheila J McNeill; Matsunaga, Fabio Teruo; dos Santos, Paulo Roberto Dias; dos Santos, Bruno Schiefer; Carrazzone, Oreste Lemos; Peixoto, Gabriel; Aoyama, Bruno Takeshi; Tamaoki, Marcel Jun Sugawara

    2017-01-01

    Background There is no consensus regarding the treatment of Achilles insertional tendinopathies. Eccentric training remains the main choice in the conservative treatment of this illness; however, the good results in the management of non-insertional Achilles tendinopathy were not replicated in the insertional condition. Low energy shock wave therapy has been described as an alternative to these patients, but has yet to be empirically tested. Hypothesis Shock wave therapy, adjunctive to the eccentric strengthening protocol, will improve measures of pain and function. Design Double blind, placebo-controlled, parallel groups, randomised clinical trial. Materials and methods 93 patients with a diagnosis of chronic insertional tendinopathy, referred from primary or secondary healthcare services, will be assessed and enrolled in this study. They will be divided into two groups (randomised by sequentially numbered identical envelopes, which will be administered serially to participants), one containing the combination of low energy shock wave and eccentric exercises, as treatment and the other comprehending the exercises and the placebo treatment (an apparatus placed in the therapeutic head). The assessments will occur in 2, 4, 6, 12 and 24 weeks. Patients will be evaluated primarily by the Victorian Institute of Sport Assessment-Achilles questionnaire and secondarily by the visual analogue scale, Algometry, the American Orthopedic Foot and Ankle Society scale, the Foot and Ankle Outcome Score and the 12-item Short Form Health Survey. We will use comparison of two proportions via relative frequency analysis, the Pearson Correlation the χ2 test and the analysis of variance for statistical analyses. Discussion This study intends to demonstrate if the association of the eccentric exercise programme with the shock wave therapy can produce good results regarding the treatment of the Achilles insertional tendinopathy. In an attempt to prevent the high costs and complications

  8. 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

  9. A treatment protocol for restoring occlusal vertical dimension using an overlay removable partial denture as an alternative to extensive fixed restorations: a clinical report.

    Science.gov (United States)

    Patel, Mit B; Bencharit, Sompop

    2009-10-30

    Treatment options for patients with severe attrition resulting in reduced occlusal vertical dimension are often limited to fixed prosthesis to reestablish proper occlusal vertical dimension and functional occlusion. In some cases such as when there are limited finances, minimal esthetic concerns, and medical considerations fixed prosthesis may not be the ideal treatment option. Overlay removable partial dentures (ORPDs) can be used as a provisional or interim prosthesis as well as permanent prosthesis in these cases. While ORPDs can provide a reversible and relatively inexpensive treatment for patients with a significantly compromised dental status, there is not much scientific evidence in the literature on ORPDs. Most studies published on ORPDs to date are primarily reviews and clinical reports. In this article, literatures on ORPDs are summarized and a patient treated with interim and permanent ORPDs is presented. This article reviews previously published literatures on the use of ORPDs. Indications, advantages and disadvantages are discussed. Treatment protocol with an example of the prosthodontic treatment of a patient with severely worn dentition with an interim ORPD and later a permanent ORPD are discussed in details.

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

    Directory of Open Access Journals (Sweden)

    Mustapha Adnane Smadi

    2013-02-01

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

  11. 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.)

  12. SheppHeartCABG trial—comprehensive early rehabilitation after coronary artery bypass grafting: a protocol for a randomised clinical trial

    Science.gov (United States)

    Moons, Philip; Hansen, Niels Viggo; La Cour, Søren; Olsen, Peter Skov; Gluud, Christian; Winkel, Per; Lindschou, Jane; Thygesen, Lau Caspar; Egerod, Ingrid; Berg, Selina Kikkenborg

    2017-01-01

    Introduction Patients undergoing coronary artery bypass graft surgery often experience a range of symptoms. Studies indicate that non-pharmacological interventions such as exercise training and psychoeducation have a positive physiological and psychological effect in early outpatient rehabilitation. The SheppHeartCABG trial will investigate the effect of early comprehensive rehabilitation in early phase rehabilitation versus usual care. The aim of this paper is to present the protocol for the SheppHeartCABG trial. Methods/analysis SheppHeartCABG is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, employing 1:1 central randomisation to rehabilitation plus usual care versus usual care alone. On the basis of a sample size calculation, 326 patients undergoing coronary artery bypass grafting will be included from two clinical sites. All patients receive usual care and patients allocated to the experimental intervention follow 4 weeks rehabilitation consisting of an exercise programme, psycho-educative consultations and a compact mindfulness programme. The primary outcome is physical function measured by the 6-min walk test. The secondary outcomes are mental health and physical activity measured by the Medical Outcome Study Short Form (SF-12), anxiety and depression measured by the Hospital Anxiety and Depression Scale questionnaire, physical, emotional and global scores by the HeartQoL questionnaire, sleep measured by the Pittsburgh Sleep Quality Index, pain measured by the Örebro Musculoskeletal Screening Questionnaire and muscle endurance measured by the sit-to-stand test. A number of explorative analyses will also be conducted. Ethics and dissemination SheppHeartCABG is approved by the regional ethics committee (no. H-4-2014-109) and the Danish Data Protection Agency (no. 30-1309) and is performed in accordance with good clinical practice and the Declaration of Helsinki in its latest form. Positive, neutral and

  13. 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.....

  14. 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

  15. Evaluating process and clinical outcomes of a primary care mental health integration project in rural Rwanda: a prospective mixed-methods protocol

    Science.gov (United States)

    Smith, Stephanie L; Misago, Claire Nancy; Osrow, Robyn A; Franke, Molly F; Iyamuremye, Jean Damascene; Dusabeyezu, Jeanne D'Arc; Mohand, Achour A; Anatole, Manzi; Kayiteshonga, Yvonne; Raviola, Giuseppe J

    2017-01-01

    Introduction Integrating mental healthcare into primary care can reduce the global burden of mental disorders. Yet data on the effective implementation of real-world task-shared mental health programmes are limited. In 2012, the Rwandan Ministry of Health and the international healthcare organisation Partners in Health collaboratively adapted the Mentoring and Enhanced Supervision at Health Centers (MESH) programme, a successful programme of supported supervision based on task-sharing for HIV/AIDS care, to include care of neuropsychiatric disorders within primary care settings (MESH Mental Health). We propose 1 of the first studies in a rural low-income country to assess the implementation and clinical outcomes of a programme integrating neuropsychiatric care into a public primary care system. Methods and analysis A mixed-methods evaluation will be conducted. First, we will conduct a quantitative outcomes evaluation using a pretest and post-test design at 4 purposively selected MESH MH participating health centres. At least 112 consecutive adults with schizophrenia, bipolar disorder, depression or epilepsy will be enrolled. Primary outcomes are symptoms and functioning measured at baseline, 8 weeks and 6 months using clinician-administered scales: the General Health Questionnaire and the brief WHO Disability Assessment Scale. We hypothesise that service users will experience at least a 25% improvement in symptoms and functioning from baseline after MESH MH programme participation. To understand any outcome improvements under the intervention, we will evaluate programme processes using (1) quantitative analyses of routine service utilisation data and supervision checklist data and (2) qualitative semistructured interviews with primary care nurses, service users and family members. Ethics and dissemination This evaluation was approved by the Rwanda National Ethics Committee (Protocol #736/RNEC/2016) and deemed exempt by the Harvard University Institutional Review

  16. 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

  17. A novel protocol that allows short-term stem cell expansion of both committed and pluripotent hematopoietic progenitor cells suitable for clinical use.

    Science.gov (United States)

    Astori, G; Malangone, W; Adami, V; Risso, A; Dorotea, L; Falasca, E; Marini, L; Spizzo, R; Bigi, L; Sala, P; Tonutti, E; Biffoni, F; Rinaldi, C; Del Frate, G; Pittino, M; Degrassi, A

    2001-01-01

    To obtain long-term engraftment and hematopoiesis in myeloablated patients, the cell population used for hematopoietic reconstitution should include a sufficient number of early pluripotent hematopoietic stem cells (HSCs), along with committed cells from the various lineages. For this purpose, the small subset of CD34+ cells purified from different sources must be expanded ex vivo. Since cytokines may induce both proliferation and differentiation, expansion would provide a cell population comprising committed as well as uncommitted cells. Optimization of HSC expansion methods could be obtained by a combination of cytokines able to sustain renewal of pluripotent cells yet endowed with poor differentiation potential. We used variations of the combinations of cytokines described by Brugger et al. [W. Brugger, S. Heimfels, R. J. Berenson, R. Mertelsmann, and L. Kanz (1995) N. Engl. J. Med. 333, 283-287] and Piacibello et al. [W. Piacibello, F. Sanavio, L. Garetto, A. Severino, D. Bergandi, J. Ferrario, F. Fagioli, M. Berger, and M. Aglietta (1997) Blood 89, 2644-2653] to expand UCB CD34+ cells and monitored proliferation rate and phenotype after 14 days of culture. Several hematopoietic lineage-associated surface antigens were evaluated. Our data show that flt3L and thrombopoietin in combination with IL-3, while sustaining a high CD34+ proliferation rate, provide a relatively low enrichment in very early uncommitted CD34+/CD38- cells. Conversely, in the absence of IL-3, they are less effective in inducing proliferation yet significantly increase the number of CD34+/CD38- cells. A combination of the above protocols, applied simultaneously to aliquots of the same sample, would allow expansion of both committed and pluripotent HSC. This strategy may represent a significant improvement for clinical applications.

  18. From protocol to published report

    DEFF Research Database (Denmark)

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

    2016-01-01

    BACKGROUND: Unacknowledged inconsistencies in the reporting of clinical trials undermine the validity of the results of the trials. Little is known about inconsistency in the reporting of academic clinical drug trials. Therefore, we investigated the prevalence of consistency between protocols and...

  19. 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

    OpenAIRE

    2012-01-01

    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 ta...

  20. 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

  1. 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

  2. Efficacy of combined conservative therapies on clinical outcomes in patients with thumb base osteoarthritis: protocol for a randomised, controlled trial (COMBO)

    Science.gov (United States)

    Deveza, Leticia A; Wajon, Anne; Bennell, Kim L; Vicenzino, Bill; Hodges, Paul; Eyles, Jillian P; Jongs, Ray; Riordan, Edward A; Duong, Vicky; Min Oo, Win; O'Connell, Rachel; Meneses, Sarah R F

    2017-01-01

    Introduction Management of thumb base osteoarthritis (OA) using a combination of therapies is common in clinical practice; however, evidence for the efficacy of this approach is lacking. The aim of this study is to determine the effect of a combination of conservative therapies for the treatment of thumb base OA compared with an education control group. Methods and analysis This is a randomised, controlled, single-centre, two-arm superiority trial with 1:1 allocation ratio; with assessor and statistician blinded. Participants are blinded to the trial's hypothesis and to the interventions received by the opposite group. A total of 204 participants will be recruited from the community and randomised using a computer-generated schedule. The intervention group will receive education for joint protection and OA, a splint for the base of the thumb, hand exercises and topical diclofenac sodium 1% gel over 6 weeks. The control group will receive education for joint protection and OA alone. Main inclusion criteria are pain ≥40 mm (Visual Analogue Scale, 0–100) at the base of the thumb, impairment in hand function ≥6 (Functional Index for Hand Osteoarthritis, 0–30) and radiographic thumb base OA (Kellgren Lawrence grade ≥2). Participants currently receiving any of the intervention components will be excluded. Outcomes will be measured at 2, 6 and 12 weeks. The primary outcome is change in pain and hand function from baseline to 6 weeks. Other outcomes include changes in grip and pinch strength, quality of life, presence of joint swelling and tenderness, duration of joint stiffness, patient's global assessment and use of rescue medication. Analysis will be performed according to the intention-to-treat principle. Adverse events will be monitored throughout the study. Ethics and dissemination This protocol is approved by the local ethics committee (HREC/15/HAWKE/479). Dissemination will occur through presentations at international conferences and publication

  3. 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.

  4. 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

  5. The Acute Asthma Severity Assessment Protocol (AASAP) Study: Objectives and Methods of a Study to Develop an Acute Asthma Clinical Prediction Rule

    OpenAIRE

    2011-01-01

    Acute asthma exacerbations are one of the most common reasons for pediatric emergency department (PED) visits and hospitalizations, and relapse frequently necessitates repeat urgent care. While care plans exist, there are no acute asthma prediction rules (APR)to assess severity and predict outcome. The primary objective of the Acute Asthma Severity Assessment Protocol (AASAP) study is to develop a multivariable APR for acute asthma exacerbations in the pediatric patient.

  6. 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)....

  7. Protocol Implementation Generator

    DEFF Research Database (Denmark)

    Carvalho Quaresma, Jose Nuno; Probst, Christian W.

    2010-01-01

    necessary tools. In this paper, we present the Protocol Implementation Generator (PiG), a framework that can be used to add protocol generation to protocol negotiation, or to easily share and implement new protocols throughout a network. PiG enables the sharing, verification, and translation...... of communication protocols. With it, partners can suggest a new protocol by sending its specification. After formally verifying the specification, each partner generates an implementation, which can then be used for establishing communication. We also present a practical realisation of the Protocol Implementation...... Generator framework based on the LySatool and a translator from the LySa language into C or Java....

  8. 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.

  9. Developing practice protocols for advanced practice nursing.

    Science.gov (United States)

    Paul, S

    1999-08-01

    In most states, the role of an advanced practice nurse is dependent on practice protocols that provide an organized method for analyzing and managing a disease or major symptom. They are also used to control the process of medical care and to specify steps in the delivery of that care. Creating appropriate practice protocols is one of the most important precursors to implementing the advanced practice role, because they virtually drive the clinician's ability to treat or manage clinical situations or disease states. This article outlines the steps involved in developing practice protocols and discusses the content that should be included in a protocol, providing an example of narrative and algorithm format protocols. Pros and cons, as well as legal issues related to practice protocols, are also presented.

  10. 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.

  11. Cost effectiveness of preventing falls and improving mobility in people with Parkinson disease: protocol for an economic evaluation alongside a clinical trial

    Directory of Open Access Journals (Sweden)

    Menz Hylton B

    2008-09-01

    Full Text Available Abstract Background Cost of illness studies show that Parkinson disease (PD is costly for individuals, the healthcare system and society. The costs of PD include both direct and indirect costs associated with falls and related injuries. Methods This protocol describes a prospective economic analysis conducted alongside a randomised controlled trial (RCT. It evaluates whether physical therapy is more cost effective than usual care from the perspective of the health care system. Cost effectiveness will be evaluated using a three-way comparison of the cost per fall averted and the cost per quality adjusted life year saved across two physical therapy interventions and a control group. Conclusion This study has the potential to determine whether targetted physical therapy as an adjunct to standard care can be cost effective in reducing falls in people with PD. Trial Registration No: ACTRN12606000344594

  12. 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.

  13. 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.

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

    Directory of Open Access Journals (Sweden)

    Menz Hylton B

    2011-09-01

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

  15. Topological Design of Protocols

    CERN Document Server

    Jaffe, Arthur; Wozniakowski, Alex

    2016-01-01

    We give a topological simulation for tensor networks that we call the two-string model. In this approach we give a new way to design protocols, and we discover a new multipartite quantum communication protocol. We introduce the notion of topologically compressed transformations. Our new protocol can implement multiple, non-local compressed transformations among multi-parties using one multipartite resource state.

  16. 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

  17. A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial

    DEFF Research Database (Denmark)

    Kirkegaard, Hans; Pedersen, Asger Roer; Pettilä, Ville;

    2016-01-01

    BACKGROUND: The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients...... predetermine covariates for adjusted analyses and pre-specify sub-groups for sensitivity analyses. This pre-planned SAP will reduce analysis bias and add validity to the findings of this trial on the effect of length of TTM on important clinical outcomes after cardiac arrest. TRIAL REGISTRATION: Clinical...

  18. 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

  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. An efficient protocol for the generation of monocyte derived dendritic cells using serum-free media for clinical applications in post remission AML patients.

    Science.gov (United States)

    da Silva Simoneti, Gisele; Saad, Sara Teresinha Olalla; Gilli, Simone Cristina Olenscki

    2014-01-01

    Protocols for the generation of dendritic cells (DCs) using serum as a supplementation of culture media leads to reactions due to animal proteins and disease transmissions. Several types of serum-free media (SFM), based on "good manufacture practices" (GMP), have recently been used and seem to be a viable option. The aim of this study was to evaluate the results of the differentiation, maturation, and function of DCs from Acute Myeloid Leukemia patients (AML), generated in SFM and medium supplemented with autologous serum (AS). DCs were analyzed by phenotype characteristics, viability, and functionality. The results showed the possibility of generating viable DCs in all the conditions tested. In patients, the X-VIVO 15 medium was more efficient than the other media tested in the generation of DCs producing IL-12p70 (p=0.05). Moreover, the presence of AS led to a significant increase of IL-10 by DCs as compared with CellGro (p=0.05) and X-Vivo15 (p=0.05) media, both in patients and donors. We concluded that SFM was efficient in the production of DCs for immunotherapy in AML patients. However, the use of AS appears to interfere with the functional capacity of the generated DCs.

  1. Birth Defects Among Children Born to Human Immunodeficiency Virus-Infected Women Pediatric AIDS Clinical Trials Protocols 219 and 219C

    NARCIS (Netherlands)

    Brogly, Susan B.; Abzug, Mark J.; Watts, D. Heather; Cunningham, Coleen K.; Williams, Paige L.; Oleske, James; Conway, Daniel; Sperling, Rhoda S.; Spiegel, Hans; Van Dyke, Russell B.

    2010-01-01

    Background: Some studies have detected associations between in utero antiretroviral therapy (ARV) exposure and birth defects but evidence is inconclusive. Methods: A total of 2202 human immunodeficiency virus (HIV)-exposed children enrolled in the Pediatric AIDS Clinical Trials Group 219 and 219 C p

  2. Management of neck pain and associated disorders: A clinical practice guideline from the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration

    DEFF Research Database (Denmark)

    Côté, Pierre; Wong, Jessica j; Sutton, Deborah

    2016-01-01

    : range of motion and strengthening exercises, qigong, yoga, multimodal care (exercise with manipulation or mobilization), clinical massage, low-level laser therapy, or non-steroidal anti-inflammatory drugs. In view of evidence of no effectiveness, clinicians should not offer strengthening exercises alone...

  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. 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.

  5. Effect of Schroth exercises on curve characteristics and clinical outcomes in adolescent idiopathic scoliosis: protocol for a multicentre randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sanja Schreiber

    2014-12-01

    Discussion: The results will demonstrate whether Schroth exercises combined with standard of care can improve outcomes in adolescents with idiopathic scoliosis. This study has potential to influence clinical practice worldwide, where exercises are not routinely prescribed for adolescents with idiopathic scoliosis.

  6. 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

  7. Cervical radiculopathy: Study protocol of a randomised clinical trial evaluating the effect of mobilisations and exercises targeting the opening of intervertebral foramen [NCT01500044

    Directory of Open Access Journals (Sweden)

    Langevin Pierre

    2012-01-01

    Full Text Available Abstract Background Cervical radiculopathy is a common form of neck pain and has been shown to lead to severe disability. Clinical rehabilitation approaches for cervical radiculopathies commonly include exercise and manual therapy interventions targeting the opening of intervertebral foramen, but evidence regarding their effectiveness is scarce. The primary objective of this randomised clinical trial is to compare, in terms of pain and disability, a rehabilitation program targeting the opening of intervertebral foramen to a conventional rehabilitation program, for patients presenting acute or subacute cervical radiculopathies. The hypothesis is that the rehabilitation program targeting the opening of intervertebral foramen will be significantly more effective in reducing pain and disability than the conventional rehabilitation program. Methods/Design This study is a double-blind (participants and evaluators blinded randomised clinical trial that will allow the comparison of patients with a cervical radiculopathy randomly assigned to one of two groups: one group will receive a 4-week rehabilitation program targeting the opening of intervertebral foramen, and the second group will receive a 4-week conventional rehabilitation program. Thirty-six subjects with cervical radiculopathy will be recruited from participating medical and physiotherapy clinics and will be evaluated at baseline, at the end of the 4-week program and four weeks following the end of the program. The primary outcome measure will be the validated Neck Disability Index questionnaire. Secondary outcome measures will include the short version of the Disabilities of the Arm, Shoulder and Hand questionnaire, a numerical pain rating scale, cervicothoracic mobility and patients' perceived global rating of change. During the 4-week rehabilitation program, each participant will take part in eight physiotherapy treatment sessions (2 session/week and will perform a home exercise program. A

  8. 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

  9. Efficacy of zidovudine and human immunodeficiency virus (HIV) hyperimmune immunoglobulin for reducing perinatal HIV transmission from HIV-infected women with advanced disease: results of Pediatric AIDS Clinical Trials Group protocol 185.

    Science.gov (United States)

    Stiehm, E R; Lambert, J S; Mofenson, L M; Bethel, J; Whitehouse, J; Nugent, R; Moye, J; Glenn Fowler, M; Mathieson, B J; Reichelderfer, P; Nemo, G J; Korelitz, J; Meyer, W A; Sapan, C V; Jimenez, E; Gandia, J; Scott, G; O'Sullivan, M J; Kovacs, A; Stek, A; Shearer, W T; Hammill, H

    1999-03-01

    Pediatric AIDS Clinical Trials Group protocol 185 evaluated whether zidovudine combined with human immunodeficiency virus (HIV) hyperimmune immunoglobulin (HIVIG) infusions administered monthly during pregnancy and to the neonate at birth would significantly lower perinatal HIV transmission compared with treatment with zidovudine and intravenous immunoglobulin (IVIG) without HIV antibody. Subjects had baseline CD4 cell counts /=200/microL) but not with time of zidovudine initiation (5.6% vs. 4.8% if started before vs. during pregnancy; P=. 75). The Kaplan-Meier transmission rate for HIVIG recipients was 4. 1% (95% confidence interval, 1.5%-6.7%) and for IVIG recipients was 6.0% (2.8%-9.1%) (P=.36). The unexpectedly low transmission confirmed that zidovudine prophylaxis is highly effective, even for women with advanced HIV disease and prior zidovudine therapy, although it limited the study's ability to address whether passive immunization diminishes perinatal transmission.

  10. American Association of Clinical Endocrinologists and American College of Endocrinology Protocol for Standardized Production of Clinical Practice Guidelines, Algorithms, and Checklists--2014 Update and the AACe G4G Program.

    Science.gov (United States)

    Mechanick, Jeffrey I; Camacho, Pauline M; Garber, Alan J; Garber, Jeffrey R; Pessah-Pollack, Rachel; Petak, Steven M; Tangpricha, Vin; Trence, Dace L

    2014-07-01

    In 2010, the American Association of Clinical Endocrinologists (AACE) published an update to the original 2004 guidelines. This update hybridized strict evidence-based medicine methods with subjective factors and improved the efficiency of clinical practice guidelines (CPG) production, clinical applicability, and usefulness. Current and persistent shortcomings involving suboptimal implementation and protracted development timelines are addressed in the current 2014 update. The major advances include 1) formulation of an organizational educational strategy, represented by the AACE Council on Education, to address relevant teaching and decision-making tools for clinical endocrinologists, and to generate specific clinical questions to drive CPG, clinical algorithm (CA), and clinical checklist (CC) development; 2) creation and prioritization of printed and online CAs and CCs with a supporting evidence base; 3) focus on clinically relevant and question-oriented topics; 4) utilization of "cascades," where there can be more than 1 recommendation for 1 clinical question; and 5) incorporation of performance metrics to validate, optimize, and effectively update CPG, CAs, and CCs. Efforts continue to translate these clinical tools to electronic formats that can be integrated into a paperless healthcare delivery system, as well as applying them to diverse clinical settings by incorporating transcultural factors.

  11. Achievement of recommended glucose and blood pressure targets in patients with type 2 diabetes and hypertension in clinical practice – study rationale and protocol of DIALOGUE

    Directory of Open Access Journals (Sweden)

    Gitt Anselm K

    2012-12-01

    Full Text Available Abstract Background Patients with type 2 diabetes have 2–4 times greater risk for cardiovascular morbidity and mortality than those without, and this is even further aggravated if they also suffer from hypertension. Unfortunately, less than one third of hypertensive diabetic patients meet blood pressure targets, and more than half fail to achieve target HbA1c values. Thus, appropriate blood pressure and glucose control are of utmost importance. Since treatment sometimes fails in clinical practice while clinical trials generally suggest good efficacy, data from daily clinical practice, especially with regard to the use of newly developed anti-diabetic and anti-hypertensive compounds in unselected patient populations, are essential. The DIALOGUE registry aims to close this important gap by evaluating different treatment approaches in hypertensive type 2 diabetic patients with respect to their effectiveness and tolerability and their impact on outcomes. In addition, DIALOGUE is the first registry to determine treatment success based on the new individualized treatment targets recommended by the ADA and the EASD. Methods DIALOGUE is a prospective observational German multicentre registry and will enrol 10,000 patients with both diabetes and hypertension in up to 700 sites. After a baseline visit, further documentations are scheduled at 6, 12 and 24 months. There are two co-primary objectives referring to the most recent guidelines for the treatment of diabetes and hypertension: 1 individual HbA1c goal achievement with respect to anti-diabetic pharmacotherapy and 2 individual blood pressure goal achievement with different antihypertensive treatments. Among the secondary objectives the rate of major cardio-vascular and cerebro-vascular events (MACCE and the rate of hospitalizations are the most important. Conclusion The registry will be able to gain insights into the reasons for the obvious gap between the demonstrated efficacy and safety of anti

  12. 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.

  13. Effects of Acupuncture Stimulation on the Radial artery’s Pressure Pulse Wave in Healthy Young Participants: Protocol for a prospective, single-Arm, Exploratory, Clinical Study

    OpenAIRE

    Jae-Young Shin; Boncho Ku; Tae-Hun Kim; Jang Han Bae; Min-Ho Jun; Jun-Hwan Lee; Kim, Jaeuk U.

    2016-01-01

    Introduction: This study aims to investigate the effects of acupuncture stimulation on the radial artery’s pressure pulse wave, along with various hemodynamic parameters, and to explore the possible underlying mechanism of pulse diagnosis in healthy participants in their twenties. Methods and analysis: This study is a prospective, single-arm, exploratory clinical study. A total of 25 healthy participants, without regard to gender, in their twenties will be recruited by physicians. Written inf...

  14. 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....

  15. Effect of periodontal treatment on the clinical parameters of patients with rheumatoid arthritis: study protocol of the randomized, controlled ESPERA trial

    Science.gov (United States)

    2013-01-01

    Background Rheumatoid arthritis (RA) is a chronic inflammatory disorder that leads to joint damage, deformity, and pain. It affects approximately 1% of adults in developed countries. Periodontitis is a chronic oral infection, caused by inflammatory reactions to gram-negative anaerobic bacteria, and affecting about 35 to 50% of adults. If left untreated, periodontitis can lead to tooth loss. A significant association has been shown to exist between periodontitis and RA in observational studies. Some intervention studies have suggested that periodontal treatment can reduce serum inflammatory biomarkers such as C-reactive protein, or erythrocyte sedimentation rate. We hypothesize that periodontitis could be an aggravating factor in patients with RA, and that its treatment would improve RA outcomes. The aim of this clinical trial is to assess the effect of periodontal treatment on the biological and clinical parameters of patients with RA. Methods/design The ESPERA (Experimental Study of Periodontitis and Rheumatoid Arthritis) study is an open-label, randomized, controlled trial. Subjects with both RA and periodontitis will be recruited at two university hospitals in southwestern France. In total, 40 subjects will be randomized into two arms (intervention and control groups), and will be followed up for 3 months. Intervention will consist of full-mouth supra-gingival and sub-gingival non-surgical scaling and root planing, followed by systemic antibiotic therapy, local antiseptics, and oral hygiene instructions. After the 3-month follow-up period, the same intervention will be applied to the subjects randomized to the control group. The primary outcome will be change of in Disease Activity Score in 28 Joints (DAS28) at the end of the follow-up period. Secondary outcomes will be the percentages of subjects with 20%, 50%, and 70% improvement in disease according to the American College of Rheumatology criteria. Health-related quality of life assessments (the Health

  16. 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

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

    Directory of Open Access Journals (Sweden)

    Crawcour Stephen

    2012-05-01

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

  18. 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

  19. 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.

  20. 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

  1. ‘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

  2. Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin in HIV type 1-infected children (Pediatric AIDS clinical trials group protocol 273).

    Science.gov (United States)

    Stiehm, E R; Fletcher, C V; Mofenson, L M; Palumbo, P E; Kang, M; Fenton, T; Sapan, C V; Meyer, W A; Shearer, W T; Hawkins, E; Fowler, M G; Bouquin, P; Purdue, L; Sloand, E M; Nemo, G J; Wara, D; Bryson, Y J; Starr, S E; Petru, A; Burchett, S

    2000-02-01

    The clinical, immunologic, and virologic effects and the pharmacokinetics of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin (HIVIG) were assessed in 30 HIV-infected children aged 2-11 years. All had moderately advanced disease with an immune complex-dissociated (ICD) p24 antigen >70 pg/mL and were on stable antiviral therapy. Three groups of 10 children received 6 monthly infusions of 200, 400, or 800 mg/kg of HIVIG, and serial immunologic and virologic assays were performed. HIVIG doses as high as 800 mg/kg were safe and well tolerated. The half-life of HIVIG, determined by serial p24 antibody titers, was 13-16 days, the volume of distribution was 102-113 mL/kg, and clearance was 5.6-6.0 mL/kg/day. Plasma ICD p24 decreased during the infusions, but CD4 cell levels, plasma RNA copy number, cellular virus, immunoglobulin levels, and neutralizing antibody titers were minimally affected by the infusions. Clinical status did not change during the 6-month infusion and 3-month follow-up periods.

  3. 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.

  4. How Do Clinical Trials Work?

    Science.gov (United States)

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

  5. 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

  6. 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

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

    Directory of Open Access Journals (Sweden)

    Oranje Bob

    2011-10-01

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

  8. 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

  9. Multiparty Quantum Cryptographic Protocol

    Institute of Scientific and Technical Information of China (English)

    M. Ramzan; M. K. Khan

    2008-01-01

    We propose a multiparty quantum cryptographic protocol. Unitary operators applied by Bob and Charlie, on their respective qubits of a tripartite entangled state encoding a classical symbol that can be decoded at Alice's end with the help of a decoding matrix. Eve's presence can be detected by the disturbance of the decoding matrix. Our protocol is secure against intercept-resend attacks. Furthermore, it is efficient and deterministic in the sense that two classical bits can be transferred per entangled pair of qubits. It is worth mentioning that in this protocol, the same symbol can be used for key distribution and Eve's detection that enhances the effciency of the protocol.

  10. 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

    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...... about head-to-head differences in efficacy and tolerability of antipsychotics are scarce in children and adolescents. The TEA trial aims at expanding the evidence base for the use of antipsychotics in early onset psychosis in order to inform more rational treatment decisions in this vulnerable......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...

  11. 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

    measures are the five subscales of the Hip disability and Osteoarthritis Outcome Score, physical activity (UCLA activity score), and patient’s global perceived effect. Other measures include pain after exercise, joint-specific adverse events, exercise adherence, general health status (EQ-5D-5L), mechanical...... 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...

  12. 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

  13. 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

    the effect and cost-effectiveness of preventive manual care (chiropractic maintenance care) in a population of patients with recurrent or persistent LBP.Four hundred consecutive study subjects with recurrent or persistent LBP will be recruited from chiropractic clinics in Sweden. The primary outcome...... of the study is quality-adjusted life years and will be calculated using the EQ-5D questionnaire. Direct medical costs as well as indirect costs will be considered.Subjects are randomly allocated into two treatment arms: 1) Symptom-guided treatment (patient controlled), receiving care when patients feel a need...... 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...

  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. UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Craig Fiona F

    2012-04-01

    Full Text Available Abstract Background Pyoderma gangrenosum (PG is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network’s STOP GAP Trial has been designed to address this lack of trial evidence. Methods The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day to prednisolone (0.75 mg/kg/day. A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers. Secondary outcomes include: (i time to healing; (ii global assessment of improvement; (iii PG inflammation assessment scale score; (iv self-reported pain; (v health-related quality of life; (vi time to recurrence; (vii treatment failures; (viii adverse reactions to study medications; and (ix cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG; measurable ulceration (that is, not pustular PG; and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size

  16. Nurses' decision-making in ethically relevant clinical situations using the example of breathlessness: study protocol of a reflexive grounded theory integrating Goffman's framework analysis

    Science.gov (United States)

    Dunger, Christine; Schnell, Martin W; Bausewein, Claudia

    2017-01-01

    Introduction Decision-making (DM) in healthcare can be understood as an interactive process addressing decision makers' reasoning as well as their visible behaviour after the decision is made. Other key elements of DM are ethical aspects and the role as well as the treatment options of the examined professions. Nurses' DM to choose interventions in situations of severe breathlessness is such interactions. They are also ethically relevant regarding the vulnerability of affected patients and possible restrictions or treatment options. The study aims to explore which factors influence nurses' DM to use nursing interventions in situations where patients suffer from severe breathlessness. Methods and analysis Qualitative study including nurses in German hospital wards and hospices. A triangulation of different methods of data collection—participant observation and qualitative expert interviews—and analysis merge in a reflexive grounded theory approach which integrates Goffman's framework analysis. It allows an analysis of nurses' self-statements about DM, their behaviour in relevant clinical situations and its influences. Data collection and analysis will be examined simultaneously. Ethics and dissemination Informed consent will be gained from all participants and the institutional stakeholders. Ongoing consent has to be ensured since observations will take place in healthcare institutions and many patients will be highly vulnerable. The study has been evaluated and approved by the Witten/Herdecke University Ethics Committee, Witten, Germany. Results of the study will be published at congresses and in journal papers.

  17. Efficacy of a brief multifactorial adherence-based intervention on reducing the blood pressure of patients with poor adherence: protocol for a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Llobera Joan

    2010-09-01

    Full Text Available Abstract Background Lowering of blood pressure by antihypertensive drugs reduces the risks of cardiovascular events, stroke, and total mortality. However, poor adherence to antihypertensive medications reduces their effectiveness and increases the risk of adverse events. In terms of relative risk reduction, an improvement in medication adherence could be as effective as the development of a new drug. Methods/Design The proposed randomized controlled trial will include patients with a low adherence to medication and uncontrolled blood pressure. The intervention group will receive a multifactorial intervention during the first, third, and ninth months, to improve adherence. This intervention will include motivational interviews, pill reminders, family support, blood pressure self-recording, and simplification of the dosing regimen. Measurement The primary outcome is systolic blood pressure. The secondary outcomes are diastolic blood pressure, proportion of patients with adequately controlled blood pressure, and total cost. Discussion The trial will evaluate the impact of a multifactorial adherence intervention in routine clinical practice. Ethical approval was given by the Ethical Committee on Human Research of Balearic islands, Spain (approval number IB 969/08 PI. Trial registration Current controlled trials ISRCTN21229328

  18. 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.

  19. 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

  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. 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...... instance is terminated prematurely and subsequently iterated. The combined set of leaves from all the tree instances can then be viewed as a graph code, which is decodable using belief propagation. The main design problem is determining the order of splitting, which enables successful decoding as early...... 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....

  2. Effectiveness of two physical therapy interventions, relative to dental treatment in individuals with bruxism: study protocol of a randomized clinical trial

    Science.gov (United States)

    2014-01-01

    oral health in individuals with bruxism. The study will support the practice of evidence-based physical therapy for individuals with bruxism. Data will be published after study is completed. Trial registration ClinicalTrials.gov, NCT01778881 PMID:24398115

  3. Image-derived input function derived from a supervised clustering algorithm: methodology and validation in a clinical protocol using [11C](R)-rolipram.

    Science.gov (United States)

    Lyoo, Chul Hyoung; Zanotti-Fregonara, Paolo; Zoghbi, Sami S; Liow, Jeih-San; Xu, Rong; Pike, Victor W; Zarate, Carlos A; Fujita, Masahiro; Innis, Robert B

    2014-01-01

    Image-derived input function (IDIF) obtained by manually drawing carotid arteries (manual-IDIF) can be reliably used in [(11)C](R)-rolipram positron emission tomography (PET) scans. However, manual-IDIF is time consuming and subject to inter- and intra-operator variability. To overcome this limitation, we developed a fully automated technique for deriving IDIF with a supervised clustering algorithm (SVCA). To validate this technique, 25 healthy controls and 26 patients with moderate to severe major depressive disorder (MDD) underwent T1-weighted brain magnetic resonance imaging (MRI) and a 90-minute [(11)C](R)-rolipram PET scan. For each subject, metabolite-corrected input function was measured from the radial artery. SVCA templates were obtained from 10 additional healthy subjects who underwent the same MRI and PET procedures. Cluster-IDIF was obtained as follows: 1) template mask images were created for carotid and surrounding tissue; 2) parametric image of weights for blood were created using SVCA; 3) mask images to the individual PET image were inversely normalized; 4) carotid and surrounding tissue time activity curves (TACs) were obtained from weighted and unweighted averages of each voxel activity in each mask, respectively; 5) partial volume effects and radiometabolites were corrected using individual arterial data at four points. Logan-distribution volume (V T/f P) values obtained by cluster-IDIF were similar to reference results obtained using arterial data, as well as those obtained using manual-IDIF; 39 of 51 subjects had a V T/f P error of 10%. With automatic voxel selection, cluster-IDIF curves were less noisy than manual-IDIF and free of operator-related variability. Cluster-IDIF showed widespread decrease of about 20% [(11)C](R)-rolipram binding in the MDD group. Taken together, the results suggest that cluster-IDIF is a good alternative to full arterial input function for estimating Logan-V T/f P in [(11)C](R)-rolipram PET clinical scans. This

  4. Image-derived input function derived from a supervised clustering algorithm: methodology and validation in a clinical protocol using [11C](R-rolipram.

    Directory of Open Access Journals (Sweden)

    Chul Hyoung Lyoo

    Full Text Available Image-derived input function (IDIF obtained by manually drawing carotid arteries (manual-IDIF can be reliably used in [(11C](R-rolipram positron emission tomography (PET scans. However, manual-IDIF is time consuming and subject to inter- and intra-operator variability. To overcome this limitation, we developed a fully automated technique for deriving IDIF with a supervised clustering algorithm (SVCA. To validate this technique, 25 healthy controls and 26 patients with moderate to severe major depressive disorder (MDD underwent T1-weighted brain magnetic resonance imaging (MRI and a 90-minute [(11C](R-rolipram PET scan. For each subject, metabolite-corrected input function was measured from the radial artery. SVCA templates were obtained from 10 additional healthy subjects who underwent the same MRI and PET procedures. Cluster-IDIF was obtained as follows: 1 template mask images were created for carotid and surrounding tissue; 2 parametric image of weights for blood were created using SVCA; 3 mask images to the individual PET image were inversely normalized; 4 carotid and surrounding tissue time activity curves (TACs were obtained from weighted and unweighted averages of each voxel activity in each mask, respectively; 5 partial volume effects and radiometabolites were corrected using individual arterial data at four points. Logan-distribution volume (V T/f P values obtained by cluster-IDIF were similar to reference results obtained using arterial data, as well as those obtained using manual-IDIF; 39 of 51 subjects had a V T/f P error of 10%. With automatic voxel selection, cluster-IDIF curves were less noisy than manual-IDIF and free of operator-related variability. Cluster-IDIF showed widespread decrease of about 20% [(11C](R-rolipram binding in the MDD group. Taken together, the results suggest that cluster-IDIF is a good alternative to full arterial input function for estimating Logan-V T/f P in [(11C](R-rolipram PET clinical scans. This

  5. Effectiveness of a cognitive-behavioral therapy (CBT manualized program for clinically anxious children: study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jansen Mélou

    2012-03-01

    Full Text Available Abstract Background In the Netherlands, the prevalence of anxiety disorders is 20%; and children with anxiety are at increased risk for psychopathology throughout adulthood. Recently, a revised version of a cognitive behavioral therapy manualized program called 'Thinking + Doing = Daring' (TDD was developed for children between 8 and 12 years old with an anxiety disorder. The main aim of this project is to conduct a Randomized Controlled Trial (RCT to evaluate the effectiveness of TDD. Methods/Design The CBT program will be tested with a RCT with 120 clinically anxious children (8-12 years old referred to one of three mental health care agencies. Children will be randomly assigned to the experimental (N = 60, TDD or to the control condition (N = 60, treatment as usual. The primary outcome measure will be the child's anxiety symptoms level. Secondary outcome measures will be externalizing (e.g. aggression and internalizing problems (e.g. depression. Two potential mediators of change will be examined in the current study: therapeutic alliance and parenting. Mother and child in both the experimental and control condition will be surveyed at baseline, post treatment and after 6 and 12 months (follow-up. It is hypothesized that children in the experimental condition will show a stronger decrease in anxiety symptoms compared to children that receive treatment as usual. Moreover, we expect that a strong therapeutic alliance and decreases in parental control and rejection will contribute to treatment success. Discussion Early treatment for anxiety problems has the potential to not only result in anxiety reductions, but also to prevent future problems such as substance abuse and psychopathology throughout adulthood. Our results will be immediately relevant to practice, since we are partnering with 'real world' community agencies. If the CBT program proves more effective than treatment as usual, it could be implemented in community mental health care

  6. 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

  7. Hyperopic correction: clinical validation with epithelium-on and epithelium-off protocols, using variable fluence and topographically customized collagen corneal crosslinking

    Directory of Open Access Journals (Sweden)

    Kanellopoulos AJ

    2014-12-01

    Full Text Available Anastasios John Kanellopoulos,1,2 George Asimellis1 1LaserViison.gr Clinical and Research Eye Institute, Athens, Greece; 2Department of Ophthalmology, New York University Medical School, New York, NY, USAPurpose: To report novel application of topographically-customized collagen crosslinking aiming to achieve hyperopic refractive changes. Two approaches were evaluated, one based on epithelium-off and one based on epithelium-on (transepithelial. Methods: A peripheral annular-shaped topographically customizable design was employed for high-fluence ultraviolet (UV-A irradiation aiming to achieve hyperopic refractive changes. A total of ten eyes were involved in this study. In group-A (five eyes, a customizable ring pattern was employed to debride the epithelium by excimer laser ablation, while in group-B (also five eyes, the epithelium remained intact. In both groups, specially formulated riboflavin solutions were applied. Visual acuity, cornea clarity, keratometry, topography, and pachymetry with a multitude of modalities, as well as endothelial cell counts were evaluated. Results: One year postoperatively, the following changes have been noted: in group-A, average uncorrected distance visual acuity changed from 20/63 to 20/40. A mean hyperopic refractive increase of +0.75 D was achieved. There was some mild reduction in the epithelial thickness. In group-B, average uncorrected distance visual acuity changed from 20/70 to 20/50. A mean hyperopic refractive increase of +0.85 D was achieved. Epithelial thickness returned to slightly reduced levels (compared to baseline in group-A, whereas to slightly increased levels in group-B. Conclusion: We introduce herein the novel application of a topographically-customizable collagen crosslinking to achieve a hyperopic refractive effect. This novel technique may be applied either with epithelial removal, offering a more stable result or with a non-ablative and non-incisional approach, offering a minimally

  8. 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

  9. 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.

  10. 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

  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. 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......Current approaches to electronic implementations of voting protocols involve translating legal text to source code of an imperative programming language. Because the gap between legal text and source code is very large, it is difficult to trust that the program meets its legal specification...... implementations that closely correspond to their legal specification, thereby increasing trust....

  13. 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

  14. The study protocol for a non-randomized controlled clinical trial using a genotype-guided strategy in a dataset of patients who undergone percutaneous coronary intervention with stent

    Directory of Open Access Journals (Sweden)

    Cristina Lucía Dávila-Fajardo

    2017-02-01

    Full Text Available This article contains data related to the research article entitled “Results of genotype–guided antiplatelet therapy in patients undergone percutaneous coronary intervention with stent” (J. Sánchez-Ramos, C.L. Dávila-Fajardo, P. Toledo Frías, X. Díaz Villamarín, L.J. Martínez-González, S. Martínez Huertas, F. Burillo Gómez, J. Caballero Borrego, A. Bautista Pavés, M.C. Marín Guzmán, J.A. Ramirez Hernández, C. Correa Vilches, J. Cabeza Barrera, 2016 (1. This data article reports, for the first time, about the non-randomized clinical trial protocol that check if CYP2C19/ABCB1 genotype–guided strategy in which the choice of antiplatelet therapy is based on the genetic test, reduces the rates of cardiovascular events and bleeding compared to a non-tailored strategy in patients undergone percutaneous coronary intervention (PCI with stent. The data included in this article are: design and setting of the study, study population, inclusion and exclusion criteria, definition of the intervention, objectives, variables (baseline characteristics and during the follow-up, study procedures, collection and treatment of the biological sample, genotyping, withdrawal criteria, sample size, statistic analysis, ethical aspects, information sheet and consent form. The authors confirm that this study has been registered in Eudra CT (Eudra CT: 2016-001294-33.

  15. 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

  16. 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.

  17. Quantum deniable authentication protocol

    Science.gov (United States)

    Shi, Wei-Min; Zhou, Yi-Hua; Yang, Yu-Guang

    2014-07-01

    The proposed quantum identity authentication schemes only involved authentication between two communicators, but communications with deniability capability are often desired in electronic applications such as online negotiation and electronic voting. In this paper, we proposed a quantum deniable authentication protocol. According to the property of unitary transformation and quantum one-way function, this protocol can provide that only the specified receiver can identify the true source of a given message and the specified receiver cannot prove the source of the message to a third party by a transcript simulation algorithm. Moreover, the quantum key distribution and quantum encryption algorithm guarantee the unconditional security of this scheme. Security analysis results show that this protocol satisfies the basic security requirements of deniable authentication protocol such as completeness and deniability and can withstand the forgery attack, impersonation attack, inter-resend attack.

  18. Unconditionally Secure Protocols

    DEFF Research Database (Denmark)

    Meldgaard, Sigurd Torkel

    the secure computation. Especially we look at the communication complexity of protocols in this model, and perfectly secure protocols. We show general protocols for any finite functionality with statistical security and optimal communication complexity (but exponential amount of preprocessing). And for two......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...... 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...

  19. 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.

  20. Comparison of the effectiveness of three manual physical therapy techniques in a subgroup of patients with low back pain who satisfy a clinical prediction rule: Study protocol of a randomized clinical trial [NCT00257998

    Directory of Open Access Journals (Sweden)

    Childs John D

    2006-02-01

    Full Text Available Abstract Background Recently a clinical prediction rule (CPR has been developed and validated that accurately identifies patients with low back pain (LBP that are likely to benefit from a lumbo-pelvic thrust manipulation. The studies that developed and validated the rule used the identical manipulation procedure. However, recent evidence suggests that different manual therapy techniques may result similar outcomes. The purpose of this study is to investigate the effectiveness of three different manual therapy techniques in a subgroup of patient with low back pain that satisfy the CPR. Methods/Design Consecutive patients with LBP referred to physical therapy clinics in one of four geographical locations who satisfy the CPR will be invited to participate in this randomized clinical trial. Subjects who agree to participate will undergo a standard evaluation and complete a number of patient self-report questionnaires including the Oswestry Disability Index (OSW, which will serve as the primary outcome measure. Following the baseline examination patients will be randomly assigned to receive the lumbopelvic manipulation used in the development of the CPR, an alternative lumbar manipulation technique, or non-thrust lumbar mobilization technique for the first 2 visits. Beginning on visit 3, all 3 groups will receive an identical standard exercise program for 3 visits (visits 3,4,5. Outcomes of interest will be captured by a therapist blind to group assignment at 1 week (3rd visit, 4 weeks (6th visit and at a 6-month follow-up. The primary aim of the study will be tested with analysis of variance (ANOVA using the change in OSW score from baseline to 4-weeks (OSWBaseline – OSW4-weeks as the dependent variable. The independent variable will be treatment with three levels (lumbo-pelvic manipulation, alternative lumbar manipulation, lumbar mobilization. Discussion This trial will be the first to investigate the effectiveness of various manual therapy

  1. 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

  2. An evidence based blunt trauma protocol

    NARCIS (Netherlands)

    Vugt, R. van; Kool, D.R.; Lubeek, S.F.; Dekker, H.M.; Brink, M.; Deunk, J.; Edwards, M.J.R.

    2013-01-01

    OBJECTIVE: Currently CT is rapidly implemented in the evaluation of trauma patients. In anticipation of a large international multicentre trial, this study's aim was to evaluate the clinical feasibility of a new diagnostic protocol, used for the primary radiological evaluation in adult blunt high-en

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

    Directory of Open Access Journals (Sweden)

    Downing Harriet

    2012-07-01

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

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

    Directory of Open Access Journals (Sweden)

    van der Heide Agnes

    2011-03-01

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

  5. SPECT/CT workflow and imaging protocols

    Energy Technology Data Exchange (ETDEWEB)

    Beckers, Catherine [University Hospital of Liege, Division of Nuclear Medicine and Oncological Imaging, Department of Medical Physics, Liege (Belgium); Hustinx, Roland [University Hospital of Liege, Division of Nuclear Medicine and Oncological Imaging, Department of Medical Physics, Liege (Belgium); Domaine Universitaire du Sart Tilman, Service de Medecine Nucleaire et Imagerie Oncologique, CHU de Liege, Liege (Belgium)

    2014-05-15

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

  6. 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...

  7. Blind Cognitive MAC Protocols

    CERN Document Server

    Mehanna, Omar; Gamal, Hesham El

    2008-01-01

    We consider the design of cognitive Medium Access Control (MAC) protocols enabling an unlicensed (secondary) transmitter-receiver pair to communicate over the idle periods of a set of licensed channels, i.e., the primary network. The objective is to maximize data throughput while maintaining the synchronization between secondary users and avoiding interference with licensed (primary) users. No statistical information about the primary traffic is assumed to be available a-priori to the secondary user. We investigate two distinct sensing scenarios. In the first, the secondary transmitter is capable of sensing all the primary channels, whereas it senses one channel only in the second scenario. In both cases, we propose MAC protocols that efficiently learn the statistics of the primary traffic online. Our simulation results demonstrate that the proposed blind protocols asymptotically achieve the throughput obtained when prior knowledge of primary traffic statistics is available.

  8. 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...

  9. 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...

  10. IP Routing Protocols

    Science.gov (United States)

    Nolasco Pinto, Armando

    2002-03-01

    Uyless Black is a widely known expert in computer networks and data communications. He is author of more than ten books in the communication technologies field, which puts him in a good position to address this topic. In IP Routing Protocols he starts by providing the background and concepts required for understanding TCP/IP technology. This is done clearly and assumes little prior knowledge of the area. As might be expected, he emphasizes the IP route discovery problem. Later he details several routing protocols.

  11. Linfoma canino: clínica, hematologia e tratamento com o protocolo de Madison-Wisconsin Canine lymphoma: clinical and hematological aspects and treatment with the Madison-Wisconsin protocol

    Directory of Open Access Journals (Sweden)

    Maria Luisa Buffo de Cápua

    2011-07-01

    Full Text Available O linfoma é uma neoplasia de elevada incidência na população canina mundial, e que apresenta sinais clínicos diversos, dependentes da classificação anatômica e da extensão da doença. Este estudo objetivou avaliar as características clínicas e hematológicas de cães com linfoma no momento do diagnóstico, além da evolução clínica dos mesmos ao longo do tratamento com o protocolo de Madison-Wisconsin. Dos 18 cães inseridos no estudo, 50% apresentaram a forma multicêntrica da doença e 33% a forma cutânea. A manifestação clínica mais comum foi a linfadenomegalia superficial, acompanhada dos sinais sistêmicos de hiporexia, apatia e perda de peso. As principais alterações hematólogicas foram anemia normocítica normocrômica, trombocitopenia e leucocitose, associadas às síndromes paraneoplásicas. Vinte e sete por cento dos animais atingiram remissão completa da doença e apenas 22% atingiram sobrevida de um ano. Houve correlação positiva entre o valor do hematócrito e o tempo de sobrevida para os cães que morreram, demonstrando a influência da anemia no prognóstico dos animais. Sugere-se que o estágio avançado da doença no momento do diagnóstico tenha influenciado as baixas taxas de remissão e sobrevida obtidas neste estudo.Lymphoma is a neoplasm of high incidence in dogs, and has several clinical signs, depending on the tumor anatomical area and the extent of the disease. This study aimed to evaluate the clinical and hematological findings in dogs with lymphoma at diagnosis, and the clinical evolution during Madison-Wisconsin chemotherapy protocol. Of the 18 dogs that underwent the study, 50% of the dogs had the multicentric form and 33% the cutaneous forms of the disease. The most common clinical sign was superficial lymphadenomegaly, combined to systemic signs of hyporexia, apathy and weight loss. The main hematological changes were anemia, thrombocytopenia and leukocytosis, associated with paraneoplastic

  12. 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.

  13. Protocol Materials: A Clarification.

    Science.gov (United States)

    Innerd, Wilfred; O'Gorman, David

    "Protocol materials" are records or recordings of a wide variety of behavioral situations. Characteristically they are neither simulated nor extensively edited. They are to be used for the empirical verification of concepts derived from both educational theory and the social sciences. They are attempts to capture reality so that it may be studied…

  14. THE MASTER PROTOCOL CONCEPT

    Science.gov (United States)

    Allegra, Carmen J.

    2015-01-01

    During the past decade, biomedical technologies have undergone an explosive evolution---from the publication of the first complete human genome in 2003, after more than a decade of effort and at a cost of hundreds of millions of dollars---to the present time, where a complete genomic sequence can be available in less than a day and at a small fraction of the cost of the original sequence. The widespread availability of next generation genomic sequencing has opened the door to the development of precision oncology. The need to test multiple new targeted agents both alone and in combination with other targeted therapies, as well as classic cytotoxic agents, demand the development of novel therapeutic platforms (particularly Master Protocols) capable of efficiently and effectively testing multiple targeted agents or targeted therapeutic strategies in relatively small patient subpopulations. Here, we describe the Master Protocol concept, with a focus on the expected gains and complexities of the use of this design. An overview of Master Protocols currently active or in development is provided along with a more extensive discussion of the Lung Master Protocol (Lung-MAP study). PMID:26433553

  15. Principles of Protocol Design

    DEFF Research Database (Denmark)

    Sharp, Robin

    This is a new and updated edition of a book first published in 1994. The book introduces the reader to the principles used in the construction of a large range of modern data communication protocols, as used in distributed computer systems of all kinds. The approach taken is rather a formal one...

  16. 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.

  17. 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。

  18. 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.

  19. 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.

  20. 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

  1. 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

  2. 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..... 

  3. Cognitive Protocol Stack Design

    Science.gov (United States)

    2015-12-30

    SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS (ES) U.S. Army Research Office P.O. Box 12211 Research Triangle Park , NC 27709-2211 cognitive...related to mobility and topology changes in a wireless multi-hop ad hoc network. (xv) We used a cross-layer formulation to design transmission...the transmission parameters, the implemented protocol and the network topology . The solution adopted involves a heuristic metric to measure how the

  4. 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)

  5. 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...

  6. CT protocol review and optimization.

    Science.gov (United States)

    Kofler, James M; Cody, Dianna D; Morin, Richard L

    2014-03-01

    To reduce the radiation dose associated with CT scans, much attention is focused on CT protocol review and improvement. In fact, annual protocol reviews will soon be required for ACR CT accreditation. A major challenge in the protocol review process is determining whether a current protocol is optimal and deciding what steps to take to improve it. In this paper, the authors describe methods for pinpointing deficiencies in CT protocols and provide a systematic approach for optimizing them. Emphasis is placed on a team approach, with a team consisting of at least one radiologist, one physicist, and one technologist. This core team completes a critical review of all aspects of a CT protocol and carefully evaluates proposed improvements. Changes to protocols are implemented only with consensus of the core team, with consideration of all aspects of the CT examination, including image quality, radiation dose, patient care and safety, and workflow.

  7. 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.

  8. 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

  9. 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...

  10. Clinical analysis of effectiveness and adverse reactions of different immunosuppressive protocols after kidney transplantation%肾移植后不同免疫抑制方案的效果及不良反应的临床分析

    Institute of Scientific and Technical Information of China (English)

    田普训; 薛武军; 丁小明; 潘晓鸣; 燕航; 冯新顺; 侯军; 项和立; 田晓辉

    2011-01-01

    Objective To summarize the incidence and treatment experience of the effectiveness and adverse reactions of the different immunosuppressive protocols and to increase the long-term survival rate in kidney recipients. Methods Single-center retrospective analysis was performed on 3102 cases of kidney transplant recipients in effectiveness and adverse reactions of different immunosuppressive protocols. The immunosuppressive protocols were as follows: CsA + Aza + Pred,low dose CsA + MMF + Pred, low dose Tac + MMF + Pred, low dose CsA + SRL + Pred, and low dose Tac+ SRL+ Pred. Results The 1-, 5-, 10-year survival rate of patients/kidney in low dose CsA + MMF + Pred protocol was higher than that in CsA + Aza + Pred protocol. The incidence of adverse reactions, such as hypertension, hyperuricemia, kidney and liver toxicity, and leukopenia was significantly lower, but the incidence of diarrhea was significantly higher in CsA + MMF + Pred protocol than in CsA + Aza + Pred protocol (all P<0. 01). The incidence of hyperglycemia was significantly higher (P<0. 05), and that of hairy and gingival hyperplsia was significantly lower (P<0. 05) in low dose Tac+ MMF+ Pred than in low dose CsA+ MMF+ Pred protocol. The incidence of hyperlipidemia in low dose CsA (or Tac)+ SRL + Pred was significantly higher than in CsA (or Tac)+ MMF+ Pred protocol (P<0. 05). The incidence of hirsutism in low dose Tac + SRL + Pred was significantly lower than that in CsA + SRL + Pred protocol (P < 0. 05). The incidence of hyperglycemia in low dose Tac + SRL + Pred was significantly higher than that in low dose CsA + SRL + Pred protocol. Conclusion The triple drug protocol with a low dose of CsA (or Tac)+ MMF+ Pred significantly improved the survival of renal transplant recipients and graft, and reduced the incidence of adverse reactions, especially Tae + MMF + Pred protocol. Adjustment of the immunosuppressant dosage and protocol, improvement of eating habits, exercise, reduction of blood

  11. 3种不同超促排卵方案在高龄患者体外受精-胚胎移植中的临床效果分析%Clinical efficacy of three controlled ovarian hyperstimulation protocols in advanced age undergoing in vitro fertilization and embryo transfer

    Institute of Scientific and Technical Information of China (English)

    杨菁; 冯亭亭; 孙伟; 冯雪花; 冯晓军; 贾婷

    2016-01-01

    Objective:To assess the efficacy of different controlled ovarian hyperstimu-lation protocols in advanced age (36~45 years) on pregnancy outcome undergoing in vitro fer-tilization and embryo transfer. Methods:A retrospective analysis was performed in a total of 484 cycles,which were divided into three groups with different stimulation protocols:GnRH-a long protocol group( Group A,148 cycles);GnRH-ant protocol group ( Group B,165cycles);ultra-short GnRH-a protocol ( Group C,171 cycles). The general conditions and the clinical out-comes of the three groups were compared. Results:The level LH on hCG injection day in group A was significantly lower than that in group B and group C. Group A had the longest duration of gonadotrophin administration,obtained the most number of eggs,2PN fertilization,2PN cleav-age,high-quality embryos and frozen embryos (P0. 05). Embryo implantation rate and clinical pregnancy rate in group A was the highest, the second in group B, the lowest ingroup C,while there was significant difference between group A and group C. Conclusion:Gn-RH-a long protocol has a better clinical outcome for advanced age with relatively better ovarian reserve function;for advanced age with poor ovarian reserve,GnRH-ant protocol has an accepta-ble clinical outcome and may be a valid alternative and comparative economic strategy,while re-quiring relatively less Gn dosage.%目的::探讨高龄(36~45岁)患者采用不同超促排卵方案对体外受精-胚胎移植周期妊娠结局的影响。方法:回顾分析484个周期的高龄患者的资料,根据促排卵方案不同将患者分组:GnRH-a长方案组(148个周期)、拮抗剂方案组(165个周期)、GnRH-a超短方案组(171个周期),比较3组患者的基本资料及临床结局。结果:GnRH-a长方案组的hCG日LH水平低于拮抗剂方案组和GnRH-a超短方案组, GnRH-a长方案组的Gn时间最长,获卵数、2 PN受精数、2 PN卵裂数、优质胚胎数及冷冻数最多( P0.05);

  12. 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.

  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. Survey protocol for invasive species

    OpenAIRE

    Menza, Charles

    2009-01-01

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

  15. Development of a protocol that allows safe consumption of the hypoallergenic apple cultivar Santana

    NARCIS (Netherlands)

    Maas, van der M.P.; Schenk, M.F.

    2009-01-01

    The apple (Malus ×domestica) cultivar Santana was shown to have a low allergenicity in a previously reported clinical trial. A protocol was developed to validate these results outside a clinical setting and to market the Santana as a hypoallergenic apple for large-scale consumption. This protocol wa

  16. Development of a Decision Support System to Predict Physicians' Rehabilitation Protocols for Patients with Knee Osteoarthritis

    Science.gov (United States)

    Hawamdeh, Ziad M.; Alshraideh, Mohammad A.; Al-Ajlouni, Jihad M.; Salah, Imad K.; Holm, Margo B.; Otom, Ali H.

    2012-01-01

    To design a medical decision support system (MDSS) that would accurately predict the rehabilitation protocols prescribed by the physicians for patients with knee osteoarthritis (OA) using only their demographic and clinical characteristics. The demographic and clinical variables for 170 patients receiving one of three treatment protocols for knee…

  17. 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 ...... suffice to identify several authentication flaws in symmetric and asymmetric key protocols such as Needham-Schroeder symmetric key, Otway-Rees, Yahalom, Andrew secure RPC, Needham-Schroeder asymmetric key, and Beller-Chang-Yacobi MSR...

  18. 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.

  19. 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).

  20. Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice

    OpenAIRE

    Turner-Stokes, Lynne; Fheodoroff, Klemens; Jacinto, Jorge; Maisonobe, Pascal; Zakine, Benjamin

    2013-01-01

    Objectives This article provides an overview of the Upper Limb International Spasticity (ULIS) programme, which aims to develop a common core dataset for evaluation of real-life practice and outcomes in the treatment of upper-limb spasticity with botulinum toxin A (BoNT-A). Here we present the study protocol for ULIS-II, a large, international cohort study, to describe the rationale and steps to ensure the validity of goal attainment scaling (GAS) as the primary outcome measure. Methods and a...

  1. 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....

  2. 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....

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2013-12-01

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

  11. 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.

  12. Interoperation between AODV protocol and AOHR protocol for mobile ad hoc networks

    Science.gov (United States)

    Wu, Shaochuan; Wang, Changhong; Zhang, Jiayan

    2009-12-01

    Although AOHR protocol has some excellent performance, no actual network utilizes AOHR as routing protocol. It is because that this protocol cannot interoperate with AODV protocol, which is the most famous routing protocol and used all over the world. The cost will be very huge to replace AODV protocol with AOHR protocol for existing networks, so the only feasible method is to modify AOHR protocol to interoperate with AODV as introduced in this paper. The simulation results prove that the modified AOHR protocol can help the existing AODV protocol provide routing service, and the interoperation of these two routing protocols is realized.

  13. Process for Reviewing Survey Protocols

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This document describes the process for conducting two types of reviews of survey protocols. A quick assessment is used to acknowledge and describe to potential...

  14. Assessment of Established Survey Protocols

    Data.gov (United States)

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

  15. 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 elk...

  16. 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.

  17. Formal Modeling of Communication Protocols.

    Science.gov (United States)

    1981-03-01

    problems have been developed. 4 FORMAL MODELING OF COMMUNICATION PROTOCOLS The state machine model is motivated by the observation that protocols may be...simplest types of state machine model because they have only a single state variable (the state) which takes on a relatively small range of values. For...grammar, this correspondence is very apparent. For each state of the state machine model , we define a nonterminal symbol in the grammar. The inputs

  18. 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.

  19. Chest magnetic resonance imaging: a protocol suggestion*

    Science.gov (United States)

    Hochhegger, Bruno; de Souza, Vinícius Valério Silveira; Marchiori, Edson; Irion, Klaus Loureiro; Souza Jr., Arthur Soares; Elias Junior, Jorge; Rodrigues, Rosana Souza; Barreto, Miriam Menna; Escuissato, Dante Luiz; Mançano, Alexandre Dias; Araujo Neto, César Augusto; Guimarães, Marcos Duarte; Nin, Carlos Schuler; Santos, Marcel Koenigkam; Silva, Jorge Luiz Pereira e

    2015-01-01

    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. PMID:26811555

  20. 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

  1. The DOMUS study protocol

    DEFF Research Database (Denmark)

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

    2014-01-01

    BACKGROUND: The focus of Specialized Palliative Care (SPC) is to improve care for patients with incurable diseases and their families, which includes the opportunity to make their own choice of place of care and ultimately place of death. The Danish Palliative Care Trial (DOMUS) aims to investigate...... whether an accelerated transition process from oncological treatment to continuing SPC at home for patients with incurable cancer results in more patients reaching their preferred place of care and death. The SPC in this trial is enriched with a manualized psychological intervention. METHODS/DESIGN: DOMUS...... 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 standardized...

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

    Directory of Open Access Journals (Sweden)

    Tait Lynda

    2012-10-01

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

  3. 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.

  4. 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

  5. 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.

  6. Should the surgeon or the general practitioner (GP follow up patients after surgery for colon cancer? A randomized controlled trial protocol focusing on quality of life, cost-effectiveness and serious clinical events

    Directory of Open Access Journals (Sweden)

    Ringberg Unni

    2008-06-01

    Full Text Available Abstract Background All patients who undergo surgery for colon cancer are followed up according to the guidelines of the Norwegian Gastrointestinal Cancer Group (NGICG. These guidelines state that the aims of follow-up after surgery are to perform quality assessment, provide support and improve survival. In Norway, most of these patients are followed up in a hospital setting. We describe a multi-centre randomized controlled trial to test whether these patients can be followed up by their general practitioner (GP without altering quality of life, cost effectiveness and/or the incidence of serious clinical events. Methods and Design Patients undergoing surgery for colon cancer with histological grade Dukes's Stage A, B or C and below 75 years of age are eligible for inclusion. They will be randomized after surgery to follow-up at the surgical outpatient clinic (control group or follow-up by the district GP (intervention group. Both study arms comply with the national NGICG guidelines. The primary endpoints will be quality of life (QoL (measured by the EORTC QLQ C-30 and the EQ-5D instruments, serious clinical events (SCEs, and costs. The follow-up period will be two years after surgery, and quality of life will be measured every three months. SCEs and costs will be estimated prospectively. The sample size was 170 patients. Discussion There is an ongoing debate on the best method of follow-up for patients with CRC. Due to a wide range of follow-up programmes and paucity of randomized trials, it is impossible to draw conclusions about the best combination and frequency of clinic (or family practice visits, blood tests, endoscopic procedures and radiological examinations that maximize the clinical outcome, quality of life and costs. Most studies on follow-up of CRC patients have been performed in a hospital outpatient setting. We hypothesize that postoperative follow-up of colon cancer patients (according to national guidelines by GPs will not have

  7. Clinical efficacy of β-lactam/β-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum β-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR)

    Science.gov (United States)

    Gudiol, C; Royo-Cebrecos, C; Tebe, C; Abdala, E; Akova, M; Álvarez, R; Maestro-de la Calle, G; Cano, A; Cervera, C; Clemente, W T; Martín-Dávila, P; Freifeld, A; Gómez, L; Gottlieb, T; Gurguí, M; Herrera, F; Manzur, A; Maschmeyer, G; Meije, Y; Montejo, M; Peghin, M; Rodríguez-Baño, J; Ruiz-Camps, I; Sukiennik, T C; Carratalà, J

    2017-01-01

    Introduction Bloodstream infection (BSI) due to extended-spectrum β-lactamase-producing Gram-negative bacilli (ESBL-GNB) is increasing at an alarming pace worldwide. Although β-lactam/β-lactamase inhibitor (BLBLI) combinations have been suggested as an alternative to carbapenems for the treatment of BSI due to these resistant organisms in the general population, their usefulness for the treatment of BSI due to ESBL-GNB in haematological patients with neutropaenia is yet to be elucidated. The aim of the BICAR study is to compare the efficacy of BLBLI combinations with that of carbapenems for the treatment of BSI due to an ESBL-GNB in this population. Methods and analysis A multinational, multicentre, observational retrospective study. Episodes of BSI due to ESBL-GNB occurring in haematological patients and haematopoietic stem cell transplant recipients with neutropaenia from 1 January 2006 to 31 March 2015 will be analysed. The primary end point will be case-fatality rate within 30 days of onset of BSI. The secondary end points will be 7-day and 14-day case-fatality rates, microbiological failure, colonisation/infection by resistant bacteria, superinfection, intensive care unit admission and development of adverse events. Sample size The number of expected episodes of BSI due to ESBL-GNB in the participant centres will be 260 with a ratio of control to experimental participants of 2. Ethics and dissemination The protocol of the study was approved at the first site by the Research Ethics Committee (REC) of Hospital Universitari de Bellvitge. Approval will be also sought from all relevant RECs. Any formal presentation or publication of data from this study will be considered as a joint publication by the participating investigators and will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE). The study has been endorsed by the European Study Group for Bloodstream Infection and Sepsis (ESGBIS) and the European Study Group

  8. Development of a core outcome set for clinical trials in rosacea: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

    OpenAIRE

    Iyengar, Sanjana; Paula R Williamson; Schmitt, Jochen; Johannsen, Lena; Maher, Ian A.; Sobanko, Joseph F.; Cartee, Todd V.; Schlessinger, Daniel; Poon, Emily; Alam, Murad

    2016-01-01

    Background Rosacea is a chronic inflammatory disorder affecting millions of individuals worldwide. Diagnosis is based on signs and symptoms with management and treatment aimed to suppress inflammatory lesions, erythema, and telangiectasia. While many clinical trials of rosacea exist, the lack of consensus in outcome reporting across all trials poses a concern. Proper evaluation and comparison of treatment modalities is challenging. In order to address the inconsistencies present, this project...

  9. 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...

  10. 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.

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

    Directory of Open Access Journals (Sweden)

    AlAujan S

    2016-05-01

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

  12. The mesh network protocol evaluation and development

    OpenAIRE

    Pei Ping; PETRENKO Y.N.

    2015-01-01

    In this paper, we introduce a Mesh network protocol evaluation and development. It has a special protocol. We could easily to understand that how different protocols are used in mesh network. In addition to our comprehension, Multi – hop routing protocol could provide robustness and load balancing to communication in wireless mesh networks.

  13. 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.

  14. 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.

  15. 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.)

  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. Developing protocols for obstetric emergencies.

    Science.gov (United States)

    Roth, Cheryl K; Parfitt, Sheryl E; Hering, Sandra L; Dent, Sarah A

    2014-01-01

    There is potential for important steps to be missed in emergency situations, even in the presence of many health care team members. Developing a clear plan of response for common emergencies can ensure that no tasks are redundant or omitted, and can create a more controlled environment that promotes positive health outcomes. A multidisciplinary team was assembled in a large community hospital to create protocols that would help ensure optimum care and continuity of practice in cases of postpartum hemorrhage, shoulder dystocia, emergency cesarean surgical birth, eclamptic seizure and maternal code. Assignment of team roles and responsibilities led to the evolution of standardized protocols for each emergency situation.

  18. 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...... 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...

  19. 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

  20. Assessment of the effectiveness and safety of Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain: EDONOT—protocol of a randomised, parallel, controlled, double-blinded and multicentre clinical trial

    Science.gov (United States)

    Kerckhove, Nicolas; Mallet, Christophe; Pereira, Bruno; Chenaf, Chouki; Duale, Christian; Dubray, Claude; Eschalier, Alain

    2016-01-01

    Introduction Currently available analgesics are ineffective in 30–50% of patients suffering from neuropathic pain and often induce deleterious side effects. T-type calcium channel blockers (mibefradil, ethosuximide, NNC 55-0396) are of great interest for the development of new symptomatic treatments of neuropathic pain, due to their various effects on pain perception. Interestingly, ethosuximide, which has already been approved for treating epilepsy, is available on the European market for clinical use. Despite numerous preclinical data demonstrating an antinociceptive effect of ethosuximide in various animal models of neuropathic pain, no clinical studies have been published to date on the analgesic efficacy of ethosuximide in patients with neuropathic pain. Methods and analysis The Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain (EDONOT) trial is a randomised, parallel, controlled, double-blinded, multicentre clinical study. It is the first clinical trial to evaluate the efficacy and safety of ethosuximide in the treatment of non-diabetic peripheral neuropathic pain. Adult patients exhibiting peripheral neuropathic pain (Numeric Rating Scale (NRS) ≥4 and Douleur Neuropathique 4 (DN4)≥4) for at least 3 months and under stable analgesic treatment for at least 1 month will be included. Patients (n=220) will be randomly assigned to receive either ethosuximide or control treatment for 6 weeks following a 1 week run-in period. The primary end point is the intensity of neuropathic pain, assessed by NRS (0–10) before and after 6 weeks of treatment. The secondary end points are safety (adverse events are collected during the study: daily by the patient on the logbook and during planned phone calls by investigators), the intensity and features of neuropathic pain (assessed by Brief Pain Inventory (BPI) and Neuropathic Pain Symptom Inventory (NPSI) questionnaires) and health-related quality of life (assessed by Medical Outcome

  1. 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...

  2. The Network Protocol Analysis Technique in Snort

    Science.gov (United States)

    Wu, Qing-Xiu

    Network protocol analysis is a network sniffer to capture data for further analysis and understanding of the technical means necessary packets. Network sniffing is intercepted by packet assembly binary format of the original message content. In order to obtain the information contained. Required based on TCP / IP protocol stack protocol specification. Again to restore the data packets at protocol format and content in each protocol layer. Actual data transferred, as well as the application tier.

  3. To assess whether indoor residual spraying can provide additional protection against clinical malaria over current best practice of long-lasting insecticidal mosquito nets in The Gambia: study protocol for a two-armed cluster-randomised trial

    Directory of Open Access Journals (Sweden)

    Parker David

    2011-06-01

    Full Text Available Abstract Background Recently, there has been mounting interest in scaling-up vector control against malaria in Africa. It needs to be determined if indoor residual spraying (IRS with DDT will provide significant marginal protection against malaria over current best practice of long-lasting insecticidal nets (LLINs and prompt treatment in a controlled trial, given that DDT is currently the most persistent insecticide for IRS. Methods A 2 armed cluster-randomised controlled trial will be conducted to assess whether DDT IRS and LLINs combined provide better protection against clinical malaria in children than LLINs alone in rural Gambia. Each cluster will be a village, or a group of small adjacent villages; all clusters will receive LLINs and half will receive IRS in addition. Study children, aged 6 months to 13 years, will be enrolled from all clusters and followed for clinical malaria using passive case detection to estimate malaria incidence for 2 malaria transmission seasons in 2010 and 2011. This will be the primary endpoint. Exposure to malaria parasites will be assessed using light and exit traps followed by detection of Anopheles gambiae species and sporozoite infection. Study children will be surveyed at the end of each transmission season to estimate the prevalence of Plasmodium falciparum infection and the prevalence of anaemia. Discussion Practical issues concerning intervention implementation, as well as the potential benefits and risks of the study, are discussed. Trial Registration ISRCTN01738840 - Spraying And Nets Towards malaria Elimination (SANTE

  4. 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

  5. A cross-sectional survey and cross-sectional clinical trial to determine the prevalence and management of eye movement disorders and vestibular dysfunction in post-stroke patients in the sub-acute phase: protocol

    Directory of Open Access Journals (Sweden)

    Andoret Van Wyk

    2016-09-01

    Full Text Available Introduction: Visual impairment, specifically eye movement disorders and vestibular dysfunction may have a negative influence on the functional recovery in post stroke patients. This type of sensory dysfunction may further be associated with poor functional outcome in patients post stroke.Methods: In phase 1 a cross-sectional survey (n = 100 will be conducted to determine the prevalence of eye movement disorders and vestibular dysfunction in patients that sustained a stroke. A cross-sectional clinical trial (n = 60 will be conducted during phase 2 of the study to determine the effect of the combination of vestibular rehabilitation therapy (VRT and visual scanning exercises (VSE (experimental group integrated with task-specific activities compared to the effect of task-specific activities as an intervention (control group on patients that present with eye movement impairment and central vestibular dysfunction post-stroke. An audiologist will assess; (a visual acuity (static and dynamic; (b nystagmus; (c; saccadic eye movements; (d smooth pursuit eye movements; (e vestibulo-ocular reflex; and (f saccular, utricular and vestibular nerve function. An independent physiotherapist will assess; (1 cognitive function; (2 residual oculomotor visual performance; (3 visual-perceptual system; (4 functional balance; (5 a patient’s ability to modify gait in response to changing task demands; (6 functional ability; and (7 presence of anxiety and/or depression and (8 level of participation in physical activity. Ethics and dissemination: Ethics approval has been obtained from the Ethics Committee of the Faculty of Health Sciences at the University of Pretoria (UP (374/2015. The study will be submitted as fulfilment for the PhD degree at UP. Dissemination will include submission to peer-reviewed professional journals and presentation at congresses. Training of rehabilitation team members on the integration of VSE and VRT into task-specific activities in

  6. Probability Distributions over Cryptographic Protocols

    Science.gov (United States)

    2009-06-01

    exception. Cryptyc integrates use of pattern- matching in the spi calculus framework , which in turn allows the specification of nested cryptographic...programs too: the metaheuristic search for security protocols,” Information and Software Technology, vol. 43, pp. 891– 904, December 2001. 131 [9] X

  7. 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....

  8. 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…

  9. Metabolomics protocols for filamentous fungi.

    Science.gov (United States)

    Gummer, Joel P A; Krill, Christian; Du Fall, Lauren; Waters, Ormonde D C; Trengove, Robert D; Oliver, Richard P; Solomon, Peter S

    2012-01-01

    Proteomics and transcriptomics are established functional genomics tools commonly used to study filamentous fungi. Metabolomics has recently emerged as another option to complement existing techniques and provide detailed information on metabolic regulation and secondary metabolism. Here, we describe broad generic protocols that can be used to undertake metabolomics studies in filamentous fungi.

  10. 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.

  11. 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 illustrat...

  12. 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 analys...

  13. 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

  14. 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

  15. 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.

  16. 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.

  17. Formally Generating Adaptive Security Protocols

    Science.gov (United States)

    2013-03-01

    a proven version of leader election and 2/3 consensus. In 2011 we did the same for a simple version of Paxos. At each stage of the evolution as our... leader election [2] and authentication [4] would suffice for Paxos as well. In preparation for the harder protocols, we had added expressive power to the

  18. Exploring the effect of space and place on response to exercise therapy for knee and hip pain-a protocol for a double-blind randomised controlled clinical trial

    DEFF Research Database (Denmark)

    Sandal, Louise Fleng; Thorlund, Jonas Bloch; Ulrich, Roger S;

    2015-01-01

    INTRODUCTION: Context effects are described as effects of a given treatment, not directly caused by the treatment itself, but rather caused by the context in which treatment is delivered. Exercise is a recommended core treatment in clinical guidelines for musculoskeletal disorders. Although...... moderately effective overall, variation is seen in size of response to exercise across randomised controlled trial (RCT) studies. Part of this variation may be related to the fact that exercise interventions are performed in different physical environments, which may affect participants differently....... The study aims to investigate the effect of exercising in a contextually enhanced physical environment for 8 weeks in people with knee or hip pain. METHODS AND ANALYSIS: The study is a double-blind RCT. Eligible participants are 35 years or older with persisting knee and/or hip pain for 3 months...

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

    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.

  20. 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.

  1. 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

  2. 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

  3. Effects of the dose of erythropoiesis stimulating agents on cardiovascular events, quality of life, and health-related costs in hemodialysis patients: the clinical evaluation of the dose of erythropoietins (C.E. DOSE trial protocol

    Directory of Open Access Journals (Sweden)

    Strippoli Giovanni FM

    2010-06-01

    Full Text Available Abstract Background Anemia is a risk factor for death, adverse cardiovascular outcomes and poor quality of life in patients with chronic kidney disease (CKD. Erythropoietin Stimulating Agents (ESA are commonly used to increase hemoglobin levels in this population. In observational studies, higher hemoglobin levels (around 11-13 g/dL are associated with improved survival and quality of life compared to hemoglobin levels around 9-10 g/dL. A systematic review of randomized trials found that targeting higher hemoglobin levels with ESA causes an increased risk of adverse vascular outcomes. It is possible, but has never been formally tested in a randomized trial, that ESA dose rather than targeted hemoglobin concentration itself mediates the increased risk of adverse vascular outcomes. The Clinical Evaluation of the DOSe of Erythropoietins (C.E. DOSE trial will assess the benefits and harms of a high versus a low fixed ESA dose for the management of anemia in patients with end stage kidney disease. Methods/Design This is a randomized, prospective open label blinded end-point (PROBE trial due to enrol 2204 hemodialysis patients in Italy. Patients will be randomized 1:1 to 4000 IU/week versus 18000 IU/week of intravenous epoietin alfa or beta, or any other ESA in equivalent doses. The dose will be adjusted only if hemoglobin levels fall outside the 9.5-12.5 g/dL range. The primary outcome will be a composite of all-cause mortality, non fatal stroke, non fatal myocardial infarction and hospitalization for cardiovascular causes. Quality of life and costs will also be assessed. Discussion The C.E.DOSE study will help inform the optimal therapeutic strategy for the management of anemia of hemodialysis patients, improving clinical outcomes, quality of life and costs, by ascertaining the potential benefits and harms of different fixed ESA doses. Trial registration Clinicaltrials.gov NCT00827021

  4. 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.

  5. 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.

  6. Biopsy of the transplanted kidney--role of protocol biopsies.

    Science.gov (United States)

    Masin-Spasovska, J; Spasovski, G

    2012-01-01

    Traditionally, renal allograft biopsies were performed mainly in the setting of acute graft dysfunction. Recently, there has been a change of paradigms. Several reports suggested that acute rejection of the graft and chronic allograft nephropathy are often subclinical without any deterioration in the graft function. This raises the issue of biopsies in functionally stable allografts (e.g. protocol biopsies) and the clinically useful information they provide. Namely, recent reports provide evidence in favour of treating biopsy-proven subclinical rejections. Moreover, by early identification of chronic histological lesions, protocol biopsies give an opportunity for individualized immunosuppressive regimen and use of targeted therapeutic strategies, in order to prevent chronic allograft dysfunction and improve long-term graft outcome. In this review, diagnostic, therapeutic and research benefit information on protocol biopsies performed in stable kidney recipients are described.

  7. Uses of clinical algorithms.

    Science.gov (United States)

    Margolis, C Z

    1983-02-04

    The clinical algorithm (flow chart) is a text format that is specially suited for representing a sequence of clinical decisions, for teaching clinical decision making, and for guiding patient care. A representative clinical algorithm is described in detail; five steps for writing an algorithm and seven steps for writing a set of algorithms are outlined. Five clinical education and patient care uses of algorithms are then discussed, including a map for teaching clinical decision making and protocol charts for guiding step-by-step care of specific problems. Clinical algorithms are compared as to their clinical usefulness with decision analysis. Three objections to clinical algorithms are answered, including the one that they restrict thinking. It is concluded that methods should be sought for writing clinical algorithms that represent expert consensus. A clinical algorithm could then be written for any area of medical decision making that can be standardized. Medical practice could then be taught more effectively, monitored accurately, and understood better.

  8. Performance Evaluation of MANET Routing Protocols Based on Internet Protocols

    Directory of Open Access Journals (Sweden)

    Hilal Bello Said,

    2015-11-01

    Full Text Available The topology of mobile ad hoc network (MANET changes rapidly and unpredictably due to nodes mobility. This makes routing protocols very important to analyze so as to communicate efficiently between the wireless nodes. Another important issue in the MANET is the internet protocols IPv4 and IPV6. The former which have been conventionally in use for long and the latter which is seen as the future standard for network architecture is studied due to its improved protection and huge address space support. In this paper, performance of AODV, DYMO, OLSRv2 and OLSR are analyzed under the IPv4 and IPv6 standards using the Qualnet simulator. Distinct performance metrics viz. Packet delivery ratio, Throughput, Average End-to-End Delay, and Average jitter are selected for the experiment. The results are then analyzed and scrutinized to provide qualitative assessment of their performances.

  9. 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.

  10. 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

  11. 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.

  12. Safety and pharmacokinetics of hyperimmune anti-human immunodeficiency virus (HIV) immunoglobulin administered to HIV-infected pregnant women and their newborns. Pediatric AIDS Clinical Trials Group Protocol 185 Pharmacokinetic Study Group.

    Science.gov (United States)

    Lambert, J S; Mofenson, L M; Fletcher, C V; Moye, J; Stiehm, E R; Meyer, W A; Nemo, G J; Mathieson, B J; Hirsch, G; Sapan, C V; Cummins, L M; Jimenez, E; O'Neill, E; Kovacs, A; Stek, A

    1997-02-01

    The pharmacokinetics and safety of hyperimmune anti-human immunodeficiency virus (HIV) intravenous immunoglobulin (HIVIG) were evaluated in the first 28 maternal-infant pairs enrolled in a randomized, intravenous immunoglobulin (IVIG)-controlled trial of HIVIG maternal-infant HIV transmission prophylaxis. Using 200 mg/kg, mean half-life and volume of distribution (Vd) in women were 15 days and 72 mL/kg, respectively, after one and 32 days and 154 mL/kg after three monthly infusions, with stable 4 mL/kg/day clearance. Transplacental passage occurred. Newborn single-dose half-life, Vd, and clearance were 30 days, 143 mL/kg, and 4 mL/kg/day, respectively. HIVIG rapidly cleared maternal serum immune complex-dissociated p24 antigen, and plasma HIV-1 RNA levels were stable. Mild to moderate adverse clinical effects occurred in 2 of 103 maternal and 2 of 25 infant infusions. No adverse hematologic, blood chemistry, or immunologic effects were seen. HIVIG is well-tolerated in HIV-infected pregnant women and their newborns, clears antigenemia, crosses the placenta, and exhibits pharmacokinetics similar to those of other immunoglobulin preparations.

  13. 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.

  14. Predicting functional capacity during treadmill testing independent of exercise protocol.

    Science.gov (United States)

    Foster, C; Crowe, A J; Daines, E; Dumit, M; Green, M A; Lettau, S; Thompson, N N; Weymier, J

    1996-06-01

    Clinically useful estimates of VO2max from treadmill tests (GXT) may be made using protocol-specific equations. In many cases, GXT may proceed more effectively if the clinician is free to adjust speed and grade independent of a specific protocol. We sought to determine whether VO2max could be predicted from the estimated steady-state VO2 of the terminal exercise stage. Seventy clinically stable individuals performed GXT with direct measurement of VO2. Exercise was incremented each minute to optimize clinical examination. Measured VO2max was compared to the estimated steady-state VO2 of the terminal stage based on ACSM equations. Equations for walking or running were used based on the patient's observed method of ambulation. The measured VO2max was always less than the ACSM estimate, with a regular relationship between measured and estimated VO2max. No handrail support: VO2max = 0.869.ACSM -0.07; R2 = 0.955, SEE = 4.8 ml.min-1.kg-1 (N = 30). With handrail support: VO2max = 0.694.ACSM + 3.33; R2 = 0.833, SEE = 4.4 ml.min-1.kg-1 (N = 40). The equations were cross-validated with 20 patients. The correlation between predicted and observed values was r = 0.98 and 0.97 without and with handrail support, respectively. The mean absolute prediction error (3.1 and 4.1 ml.min-1.kg-1) were similar to protocol-specific equations. We conclude that VO2max can be predicted independent of treadmill protocol with approximately the same error as protocol-specific equations.

  15. Kioto protocol; Protocolo de Kioto

    Energy Technology Data Exchange (ETDEWEB)

    Romero, A.

    2005-07-01

    Atmospheric contamination by greenhouse gases is a global problem, and thus its solution requires global measures. Although the consequences of climate change are questioned and the foreseeable effects are not excessively serious, there are plenty of scientific reasons for all countries to make the necessary efforts to meet the objectives established by the Kyoto Protocol of reducing the six greenhouse gases over the period 2008-2012. Therefore, it seems essential that we understand the nature of the transformation that are occurring in the different systems, what changes they are causing and what costs they incur. Independently of its effectiveness and realism, the Kyoto Protocol is the first regulatory step in the direction of globalization in the environmental field. (Author)

  16. 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).

  17. 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.

  18. Heuristic Methods for Security Protocols

    Directory of Open Access Journals (Sweden)

    Qurat ul Ain Nizamani

    2009-10-01

    Full Text Available 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.

  19. 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.

  20. 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.

  1. New Models for Protocol Security

    Science.gov (United States)

    2015-06-18

    protocols and primitives (e.g., Schnorrs identification scheme, commitment schemes secure against selective openings, Chaum Blind Signatures , etc...Theory 156: 246-268 (2015) 5 3. Samantha Leung, Edward Lui, Rafael Pass: Voting with Coarse Beliefs. ITCS 2015: 61 4. Jing Chen, Silvio Micali, Rafael...Schneider: Multi-Verifier Signatures . J. Cryptology 25(2): 310-348 (2012) 7 37. Rafael Pass, Muthuramakrishnan Venkitasubramaniam: A Parallel Repetition

  2. 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...

  3. DSTC Layering Protocols in Wireless Cooperative Networks

    CERN Document Server

    Elamvazhuthi, P S; Dey, B K

    2008-01-01

    In adhoc wireless relay networks, layers of relays are used to communicate from a source to a destination to achieve better reliability. In this paper, we consider five protocols derived from an earlier proposed protocol, where the relays do a simple processing before transmitting and as a result achieve distributed space-time code. Four of the protocols discussed utilize more complicated relaying schemes than simple layered protocols proposed in earlier literature. We have analyzed the effectiveness of these protocols in various power loss configurations among the paths. Optimum power allocation of the total power among various transmissions have been found by reasonable fine search for all the protocols. Bit error rate plots are compared under optimum power allocation for these protocols. From the simulation results, we draw some guidelines as to which protocol is good for what kind of environment.

  4. Language, Semantics, and Methods for Security Protocols

    DEFF Research Database (Denmark)

    Crazzolara, Federico

    used to give a formal semantics to security protocols which supports proofs of their correctness. More precisely, we give a compositional event-based semantics to an economical, but expressive, language for describing security protocols (SPL); so the events and dependency of a wide range of protocols......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...

  5. The reliable multicast protocol application programming interface

    Science.gov (United States)

    Montgomery , Todd; Whetten, Brian

    1995-01-01

    The Application Programming Interface for the Berkeley/WVU implementation of the Reliable Multicast Protocol is described. This transport layer protocol is implemented as a user library that applications and software buses link against.

  6. Impact of number of retrieved oocytes in women under 35 years old with a long protocol for controlled ovarian hyperstimulation on the clinical outcome of in vitro fertilization and embryo transfer%35岁以下患者长方案促排卵获卵数对体外受精-胚胎移植结局的影响

    Institute of Scientific and Technical Information of China (English)

    王雅琴; 杨菁; 徐望明; 谢青贞; 肖卓妮; 尹太郎

    2011-01-01

    目的 探讨体外受精-胚胎移植(IVF-ET)周期最佳获卵数及其对妊娠结局的影响.方法 回顾性分析我院2009年9月至2010年8月35岁以下行长方案IVF-ET治疗的544个获卵周期的资料.比较不同获卵数的受精率、卵裂率、优胚率、临床妊娠率及并发症等指标的差异.结果 不同获卵数各组间促性腺激素(Gn)刺激天数、Gn用量、卵裂率、优胚率无明显差别(P>0.05),获卵数>25个组受精率低于其他各组(P15个,临床妊娠率较前下降,累积妊娠率随获卵数增加而增加,当获卵数>25个,临床妊娠率和累积妊娠率明显下降.结论 获得适量的卵有利于获得较满意的妊娠结局.%Objective: To explore the effect of retrieved oocyte number on pregnancy outcome of in vitro fertilization and embryo transfer (IVF-ET).Methods: A retrospective analysis was carried out on 544-oocyte pick up(OPU) cycles in women under 35 years old with long protocol IVF-ET in the hospital from Sep 2009 to Aug 2010. The women were divided into 6 groups according to retrieved oocyte number: Group A (≤5 oocytes), Group B (6-10 oocytes), Group C (11-15 oocytes), Group D (16-20 oocytes), Group E (21-25 oocytes), Group F(>25 oocytes). The fertilization rate, cleavage rate, advanced embryo rate, clinical pregnancy rate, accumulated clinic pregnancy rate, complications etc. in 6 groups were analyzed.Results: The gonadotropin doses, gonadotropin days, cleavage rate or advanced embryo rate showed no statistical difference in women withdifferent number of retrieved oocytes (P>0. 05). The fertilization rate in the Group F was less than that in other groups (P<0.05). The frozen embryo number, the serum E2 level and ovarian hyperstimulation syndrome rate were raised with number retrieved oocytes increased.The clinical pregnancy rate enhanced with the retrieved oocyte number increased in ≤15 oocytes of groups,while decreased in >15 oocytes of groups. The accumulated pregnancy rate

  7. 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.

  8. Security Verification of Secure MANET Routing Protocols

    Science.gov (United States)

    2012-03-22

    the destination. The route discovery phase is complete upon receipt of the RREP at the requesting node. The DYMO protocol is a simpler version of AODV ...described in this appendix. The protocols are Secure AODV (SAODV), Secure Efficient Distance Vector (SEAD), and Secure Link State Routing Protocol (SLSP...SECURITY VERIFICATION OF SECURE MANET ROUTING PROTOCOLS THESIS Matthew F. Steele, Captain, USAF AFIT/GCS/ENG/12-03 DEPARTMENT OF THE AIR FORCE AIR

  9. 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.

  10. Model checking the HAVi leader election protocol

    OpenAIRE

    Romijn, J.M.T.

    1999-01-01

    The HAVi specification proposes an architecture for audio/video interoperability in home networks. Part of the HAVi specification is a distributed leader election protocol. We have modelled this leader election protocol in Promela and Lotos and have checked several properties with the tools Spin and Xtl (from the Caesar/Aldebaran package). It turns out that the protocol does not meet some safety properties and that there are situations in which the protocol may never converge to designate a l...

  11. 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...

  12. 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 formali...

  13. 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

  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. Analysing ZigBee Key Establishment Protocols

    CERN Document Server

    Yüksel, Ender

    2012-01-01

    In this report, we present our approach for protocol analysis together with a real example where we find an important flow in a contemporary wireless sensor network security protocol. We start by modelling protocols using a specific process algebraic formalism called LySa process calculus. We then apply an analysis based on a special program analysis technique called control flow analysis. We apply this technique to the ZigBee-2007 End-to-End Application Key Establishment Protocol and with the help of the analysis discover an unknown flaw. Finally we suggest a fix for the protocol, and verify that the fix works by using the same technique.

  16. INEEL AIR MODELING PROTOCOL ext

    Energy Technology Data Exchange (ETDEWEB)

    C. S. Staley; M. L. Abbott; P. D. Ritter

    2004-12-01

    Various laws stemming from the Clean Air Act of 1970 and the Clean Air Act amendments of 1990 require air emissions modeling. Modeling is used to ensure that air emissions from new projects and from modifications to existing facilities do not exceed certain standards. For radionuclides, any new airborne release must be modeled to show that downwind receptors do not receive exposures exceeding the dose limits and to determine the requirements for emissions monitoring. For criteria and toxic pollutants, emissions usually must first exceed threshold values before modeling of downwind concentrations is required. This document was prepared to provide guidance for performing environmental compliance-driven air modeling of emissions from Idaho National Engineering and Environmental Laboratory facilities. This document assumes that the user has experience in air modeling and dose and risk assessment. It is not intended to be a "cookbook," nor should all recommendations herein be construed as requirements. However, there are certain procedures that are required by law, and these are pointed out. It is also important to understand that air emissions modeling is a constantly evolving process. This document should, therefore, be reviewed periodically and revised as needed. The document is divided into two parts. Part A is the protocol for radiological assessments, and Part B is for nonradiological assessments. This document is an update of and supersedes document INEEL/INT-98-00236, Rev. 0, INEEL Air Modeling Protocol. This updated document incorporates changes in some of the rules, procedures, and air modeling codes that have occurred since the protocol was first published in 1998.

  17. 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.

  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. Developing security protocols in χ-Spaces

    DEFF Research Database (Denmark)

    Crazzolara, Federico; Milicia, Giuseppe

    2002-01-01

    of formal protocol verification. Verification, however, is usually carried out on an abstract model not at all related with a protocol’s implementation. Experience shows that security breaches introduced in implementations of successfully verified models are rather common. The χ-Spaces framework...... is an implementation of SPL (Security Protocol Language), a formal model for studying security protocols. In this paper we discuss the use of χ-Spaces as a tool for developing robust security protocol implementations. To make the case, we take a family of key-translation protocols due to Woo and Lam and show how χ-Spaces......It is of paramount importance that a security protocol effectively enforces the desired security requirements. The apparent simplicity of informal protocol descriptions hides the inherent complexity of their interactions which, often, invalidate informal correctness arguments and justify the effort...

  1. 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.

  2. Tool Supported Analysis of Web Services Protocols

    DEFF Research Database (Denmark)

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

    2011-01-01

    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......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...... to ensure the finiteness of the protocol state-spaces while still being able to verify interesting protocol properties. The translations for different kinds of communication media have been implemented and successfully tested, among others, on agreement protocols from WS-Business Activity....

  3. 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.

  4. 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

  5. Experimental quantum multiparty communication protocols

    Science.gov (United States)

    Smania, Massimiliano; Elhassan, Ashraf M.; Tavakoli, Armin; Bourennane, Mohamed

    2016-06-01

    Quantum information science breaks limitations of conventional information transfer, cryptography and computation by using quantum superpositions or entanglement as resources for information processing. Here we report on the experimental realisation of three-party quantum communication protocols using single three-level quantum system (qutrit) communication: secret-sharing, detectable Byzantine agreement and communication complexity reduction for a three-valued function. We have implemented these three schemes using the same optical fibre interferometric setup. Our realisation is easily scalable without compromising on detection efficiency or generating extremely complex many-particle entangled states.

  6. A structured data transfer protocol

    Science.gov (United States)

    Barrett, P.; Rots, A.

    1992-01-01

    The transfer of data between different computers and programs can be a major obstacle during data analysis. We present a new data transfer protocol which is based on a simple structure containing a value, an error, and a unit. Each of these members can be arrays or another structure. The ability to nest structures allows for the concept of objects. When using an object-oriented language such as C++, reference can be made to the object name instead of each element explicitly. Prototype code has been written which implements the basic design with enhancements planned for the future.

  7. 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.

  8. 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.

  9. Nausea and vomiting in advanced cancer: the Cleveland Clinic protocol.

    Science.gov (United States)

    Gupta, Mona; Davis, Mellar; LeGrand, Susan; Walsh, Declan; Lagman, Ruth

    2013-03-01

    Nausea and vomiting are common and distressing symptoms in advanced cancer. Both are multifactorial and cause significant morbidity, nutritional failure, and reduced quality of life. Assessment includes a detailed history, physical examination and investigations for reversible causes. Assessment and management will be influenced by performance status, prognosis, and goals of care. Several drug classes are effective with some having the added benefit of multiple routes of administration. It is our institution's practice to recommend metoclopramide as the first drug with haloperidol as an alternative antiemetic. Dexamethasone should be used for patients with central nervous system metastases or bowel obstruction. If your patient is near death, empiric metoclopramide, haloperidol or chlorpromazine is used without further investigation. For patients with a better prognosis, we exclude reversible causes and use the same first-line antiemetics, metoclopramide and haloperidol. For those who do not respond to first-line single antiemetics, olanzapine is second line and ondansetron is third. Rarely do we use combination therapy or cannabinoids. Olanzapine as a single agent has a distinct advantage over antiemetic combinations. It improves compliance, reduces drug interactions and has several routes of administration. Antiemetics, anticholinergics, octreotide and dexamethasone are used in combination to treat bowel obstruction. In opiod-na'ive patients, we prefer haloperidol, glycopyrrolate and an opioid as the first-line treatment and add or substitute octreotide and dexamethasone in those who do not respond. Non-pharmacologic interventions (mechanical stents and percutaneous endoscopic gastrostomy tubes) are used when nausea is refractory to medical management or for home-going management to relieve symptoms, reduce drug costs and rehospitalization.

  10. 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 ...

  11. 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.

  12. Merging Multiparty Protocols in Multiparty Choreographies

    Directory of Open Access Journals (Sweden)

    Fabrizio Montesi

    2013-02-01

    Full Text Available Choreography-based programming is a powerful paradigm for defining communication-based systems from a global viewpoint. A choreography can be checked against multiparty protocol specifications, given as behavioural types, that may be instantiated indefinitely at runtime. Each protocol instance is started with a synchronisation among the involved peers. We analyse a simple transformation from a choreography with a possibly unbounded number of protocol instantiations to a choreography instantiating a single protocol, which is the merge of the original ones. This gives an effective methodology for obtaining new protocols by composing existing ones. Moreover, by removing all synchronisations required for starting protocol instances, our transformation reduces the number of communications and resources needed to execute a choreography.

  13. 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.

  14. Design a usable protocol screening database: the user-centered approach.

    Science.gov (United States)

    Xie, Zhong; Suki, Dima; Graham, Susan; Sawaya, Raymond

    2005-01-01

    Patient eligibility screening is a very important component of clinical research. Data obtained from such a task can serve valuable purposes beyond the specific protocol they are generated for and therefore should be captured and stored. We applied a user-centered design framework to evaluate the existing screening process and database at the Neurosurgery Department, M. D. Anderson Cancer Center and to design and develop a usable protocol patient screening interface.

  15. 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.

  16. 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...... standards used for implementing the service-oriented applications. By doing so, we will be able to not only reason about applications at different levels of abstractions, but also to build a bridge between the views of researchers on formal methods and developers in industry. We apply our approach...... 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....

  17. Secure Multi-Player Protocols

    DEFF Research Database (Denmark)

    Fehr, Serge

    secret sharing in terms of simple algebraic conditions on the integer sharing coefficients, and we propose a black-box secret sharing scheme with minimal expansion factor. Note that, in contrast to the classical field-based secret sharing schemes, a black-box secret sharing scheme allows to share......, MPC can be based on arbitrary finite rings. This is in sharp contrast to the literature where essentially all MPC protocols require a much stronger mathematical structure, namely a field. Apart from its theoretical value, this can lead to efficiency improvements since it allows a greater freedom...... ones. We also construct a noninteractive distributed-verifier proof of circuit satisfiability, which—in principle—allows to prove anything that can be proven without giving away the proof....

  18. [Climate change and Kyoto protocol].

    Science.gov (United States)

    Ergasti, G; Pippia, V; Murzilli, G; De Luca D'Alessandro, E

    2009-01-01

    Due to industrial revolution and the heavy use of fossil fuels, the concentration of greenhouse gases in the atmosphere has increased dramatically during the last hundred years, and this has lead to an increase in mean global temperature. The environmental consequences of this are: the melting of the ice caps, an increase in mean sea-levels, catastrophic events such as floodings, hurricanes and earthquakes, changes to the animal and vegetable kingdoms, a growth in vectors and bacteria in water thus increasing the risk of infectious diseases and damage to agriculture. The toxic effects of the pollution on human health are both acute and chronic. The Kyoto Protocol is an important step in the campaign against climatic changes but it is not sufficient. A possible solution might be for the States which produce the most of pollution to adopt a better political stance for the environment and to use renewable resources for the production of energy.

  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. 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].

  1. The Braid-Based Bit Commitment Protocol

    Institute of Scientific and Technical Information of China (English)

    WANG Li-cheng; CAO Zhen-fu; CAO Feng; QIAN Hai-feng

    2006-01-01

    With recent advances of quantum computation, new threats have closed in upon to the classical public key cryptosystems. In order to build more secure bit commitment schemes, this paper gave a survey of the new coming braid-based cryptography and then brought forward the first braid-based bit commitment protocol. The security proof manifests that the proposed protocol is computationally binding and information-theoretically hiding.Furthermore, the proposed protocol is also invulnerable to currently known quantum attacks.

  2. Reasoning about Protocol Change and Knowledge

    Science.gov (United States)

    Wang, Yanjing

    In social interactions, protocols govern our behaviour and assign meaning to actions. In this paper, we investigate the dynamics of protocols and their epistemic effects. We develop two logics, inspired by Propositional Dynamic Logic (PDL) and Public Announcement Logic (PAL), for reasoning about protocol change and knowledge updates. We show that these two logics can be translated back to the standard PDL and PAL respectively.

  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. Traffic Performance Analysis of Manet Routing Protocol

    CERN Document Server

    Rajeswari, S; 10.5121/ijdps.2011.2306

    2011-01-01

    The primary objective of this research work is to study and investigate the performance measures of Gossip Routing protocol and Energy Efficient and Reliable Adaptive Gossip routing protocols. We use TCP and CBR based traffic models to analyze the performance of above mentioned protocols based on the parameters of Packet Delivery Ratio, Average End-to-End Delay and Throughput. We will investigate the effect of change in the simulation time and Number of nodes for the MANET routing protocols. For Simulation, we have used ns-2 simulator.

  5. 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.

  6. Status Report on the UNIDROIT Space Protocol

    Science.gov (United States)

    Larsen, Paul B.

    2002-01-01

    In my status report on the UNIDROIT Space Protocol I will describe the history and purpose of the Space Protocol; I will state the Protocol's relationship to the UNIDROIT Convention on International Interests in Mobile Equipment in particular after the 2001 Cape Town Diplomatic Conference on the Convention. I will describe the COPUOS study of possible conflicts with the existing space law treaties and explain UNIDROIT's objective of avoiding conflicts between existing space law and the Space Protocol. Finally I will describe future steps to be taken.

  7. 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.

  8. 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

  9. Wireless sensors networks MAC protocols analysis

    CERN Document Server

    Chaari, Lamia

    2010-01-01

    Wireless sensors networks performance are strictly related to the medium access mechanism. An effective one, require non-conventional paradigms for protocol design due to several constraints. An adequate equilibrium between communication improvement and data processing capabilities must be accomplished. To achieve low power operation, several MAC protocols already proposed for WSN. The aim of this paper is to survey and to analyze the most energy efficient MAC protocol in order to categorize them and to compare their performances. Furthermore we have implemented some of WSN MAC protocol under OMNET++ with the purpose to evaluate their performances.

  10. 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.

  11. 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.

  12. 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

  13. 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

  14. 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.

  15. Wind power agreement protocol; Protocole d'accord eolien

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2002-10-01

    The aim of this protocol of agreement is to propose to wind turbine fitters some models of contracts allowing the setting up of wind turbines on agricultural lots. These documents, which make an indissociable ensemble, apply to both phases of development of a wind power project: the feasibility study phase, for a duration comprised between 2 and 5 years (studies, administrative procedures, precise definition of the project), and the construction, exploitation and dismantling phase. These documents will serve as common guidelines for both the farmers and the wind turbine designers. Both parties agree to meet together in the future to propose some modifications of these texts if necessary. The four models of contracts are attached to the document: contract for the feasibility study phase, first contract between the landlord and the farmer for the cancellation of the rural lease, second contract between the landlord and the wind power exploitation company for the common right lease, and the third contract between the farmer and the wind power company for the indemnification convention. (J.S.)

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

    Science.gov (United States)

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

    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

  17. Comment on "flexible protocol for quantum private query based on B92 protocol"

    Science.gov (United States)

    Chang, Yan; Zhang, Shi-Bin; Zhu, Jing-Min

    2017-03-01

    In a recent paper (Quantum Inf Process 13:805-813, 2014), a flexible quantum private query (QPQ) protocol based on B92 protocol is presented. Here we point out that the B92-based QPQ protocol is insecure in database security when the channel has loss, that is, the user (Alice) will know more records in Bob's database compared with she has bought.

  18. 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.

  19. Mobile IPv6 Protocols and Implementation

    CERN Document Server

    Li, Qing; Shima, Keiichi

    2009-01-01

    Mobile IPv6 has become the key enabling technology for mobile data and multimedia services and devices worldwide. This book covers the IPv6 host mobility protocol known as 'mobile IPv6' and begins with a basic description of mobile IPv6 and then details protocol specifications and data structures as well as actual implementation.

  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. Algebraic techniques for low communication secure protocols

    NARCIS (Netherlands)

    Haan, Robbert de

    2009-01-01

    This thesis discusses new results in two areas within cryptography; securely transmitting a message between two parties and securely computing a function on the inputs of multiple parties. For both of these areas we mainly consider perfectly secure protocols, which are protocols that have a zero err

  2. 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...

  3. 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.

  4. Beveiliging Internet Protocol beter en beter

    NARCIS (Netherlands)

    Luiijf, H.A.M.

    1999-01-01

    Iedereen die gebruik maakt van e-mail, internet, intranet of extranet maakt gebruik van het in de jaren 7O ontworpen IP het Internet Protocol. Dit protocol zorgt ervoor dat toegang tot de diverse internetdiensten mogelijk is. Iedere computer die op internet wordt aangesloten, krijgt een eigen IP-adr

  5. 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

  6. 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.

  7. 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 b...

  8. Concurrent Validity of a Pragmatic Protocol.

    Science.gov (United States)

    Duncan, Julie Condon; Perozzi, Joseph A.

    1987-01-01

    The scores of 11 non-handicapped kindergarten children on the Pragmatic Protocol (used in assessing language-handicapped children) were correlated with their ratings by five experienced judges on a 7-point equal-appearing interval scale of communicative competence. The concurrent validity of the Protocol and interobserver reliability were…

  9. 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.

  10. A Survey on Distance Vector Routing Protocols

    CERN Document Server

    Tang, Linpeng

    2011-01-01

    In this paper we give a brief introduction to five different distance vector routing protocols (RIP, AODV, EIGRP, RIP-MTI and Babel) and give some of our thoughts on how to solve the count to infinity problem. Our focus is how distance vector routing protocols, based on limited information, can prevent routing loops and the count to infinity problem.

  11. 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.

  12. Model checking the HAVi leader election protocol

    NARCIS (Netherlands)

    Romijn, J.M.T.

    1999-01-01

    The HAVi specification proposes an architecture for audio/video interoperability in home networks. Part of the HAVi specification is a distributed leader election protocol. We have modelled this leader election protocol in Promela and Lotos and have checked several properties with the tools Spin a

  13. 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.

  14. 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.

  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. 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.

  17. 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.

  18. 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.

  19. Quantum Communication Attacks on Classical Cryptographic Protocols

    DEFF Research Database (Denmark)

    Damgård, Ivan Bjerre

    In the literature on cryptographic protocols, it has been studied several times what happens if a classical protocol is attacked by a quantum adversary. Usually, this is taken to mean that the adversary runs a quantum algorithm, but communicates classically with the honest players. In several cases......, one can show that the protocol remains secure even under such an attack. However, there are also cases where the honest players are quantum as well, even if the protocol uses classical communication. For instance, this is the case when classical multiparty computation is used as a “subroutine......” in quantum multiparty computation. Furthermore, in the future, players in a protocol may employ quantum computing simply to improve efficiency of their local computation, even if the communication is supposed to be classical. In such cases, it no longer seems clear that a quantum adversary must be limited...

  20. 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...

  1. Similarity based mixed transaction concurrency control protocol

    Institute of Scientific and Technical Information of China (English)

    PAN Yi; LU Yan-sheng

    2005-01-01

    Due to the various performance requirements and data access restrictions of different types of real-time transactions, concurrency control protocols which had been designed for the systems with single type of transactions are not sufficient for mixed real-time database systems (MRTDBS), where different types of real-time transactions coexist in the systems concurrently. In this paper, a new concurrency control protocol MRTT_CC for mixed real-time transactions is proposed. The new strategy integrates with different concurrency control protocols to meet the deadline requirements of different types of real-time transactions. The data similarity concept is also explored in the new protocol to reduce the blocking time of soft real-time transactions, which increases their chances to meet the deadlines. Simulation experiments show that the new protocol has gained good performance.

  2. 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.

  3. NEURAPRO-E study protocol

    DEFF Research Database (Denmark)

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

    2016-01-01

    polyunsaturated fatty acids (PUFAs), coupled with the falling transition rate in ultra high-risk (UHR) samples, mean that further study of such benign, potentially neuroprotective interventions is clinically and ethically required. Employing a multicentre approach, enabling a large sample size, this study...

  4. A Comparison Between Inter-Asterisk eXchange Protocol and Jingle Protocol: Session Time

    Directory of Open Access Journals (Sweden)

    H. S. Haj Aliwi

    2016-08-01

    Full Text Available Over the last few years, many multimedia conferencing and Voice over Internet Protocol (VoIP applications have been developed due to the use of signaling protocols in providing video, audio and text chatting services between at least two participants. This paper compares between two widely common signaling protocols: InterAsterisk eXchange Protocol (IAX and the extension of the eXtensible Messaging and Presence Protocol (Jingle in terms of delay time during call setup, call teardown, and media sessions.

  5. 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

  6. 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.

  7. Efeito do ultra-som terapêutico em tendinite experimental de eqüinos: estudo clínico, ultra-sonográfico e histopatológico de dois protocolos Clinic, ultrasonographic and histopatological studies of two protocols of ultrasonic therapy on experimental tendonitis in horses

    Directory of Open Access Journals (Sweden)

    M.A.L. Fernandes

    2003-02-01

    Full Text Available Avaliaram-se dois protocolos de ultra-som no tratamento de lesões do tendão flexor digital superficial (TFDS. Foram estudados 18 eqüinos, nos quais foi injetada uma solução de colagenase a 0,25% no TFDS esquerdo, à altura do terço médio da região metacarpiana. Os eqüinos foram divididos em: grupo A - tratado por ultra-som (UST na freqüência de 3 MHz e intensidade de 1W/cm², no modo contínuo, por seis minutos; grupo B - tratado na mesma freqüência, intensidade e tempo, no modo pulsado; e grupo C - controle. Os tratamentos foram iniciados 48h após a indução da lesão, totalizando oito sessões. Os eqüinos foram estudados por 40 dias, avaliando-se o quadro clínico e a regressão dos sintomas. Por meio de exames ultra-sonográficos semanais avaliaram-se a área transversal e a ecogenicidade da lesão para estabelecimento do índice de severidade (IS. A lesão resultou em aumento médio de 1,5cm na circunferência da região metacarpiana, resposta à pressão digital de leve a moderada e grau de claudicação de 1 a 3. A regressão dos sintomas ocorreu, em média, nove dias no grupo A, 12 dias no grupo B e 21 dias no grupo C. O percentual de regressão no IS aos 40 dias foi de 42,5, 57,7 e 34,1, respectivamente. A avaliação histológica mostrou neovascularização pronunciada e maior atividade fibroblástica nos grupos tratados (A e B comparados ao grupo-controle. Estes resultados sugerem que o UST é efetivo na redução dos sintomas clínicos da tendinite.In order to evaluate two therapeutic ultrasound protocols for treatment of injuries of the superficial digital flexor tendon (SDFT a study was performed in 18 horses. In each horse, a 0.25% solution of collagenase was injected in the middle of the left SDFT. The horses were randomly and equally divided into three groups. Horses from Group A were treated with therapeutic ultrasound of 3 MHz frequency and 1 W/cm² intensity on continuous mode for six minutes; horses from Group

  8. Universally composable protocols with relaxed set-up assumptions

    DEFF Research Database (Denmark)

    Barak, Boaz; Canetti, Ran; Nielsen, Jesper Buus;

    2004-01-01

    A desirable goal for cryptographic protocols is to guarantee security when the protocol is composed with other protocol instances. Universally composable (UC) protocols provide this guarantee in a strong sense: A protocol remains secure even when composed concurrently with an unbounded number...

  9. 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.

  10. 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...

  11. Experience of step-wise protocol using noninvasive positive pressure ventilation for treating cardiogenic pulmonary edema.

    Science.gov (United States)

    Momii, Hidetoshi; Tashima, Yuki; Kadokami, Toshiaki; Narita, Sumito; Yoshida, Masayoshi; Ando, Shin-ichi

    2012-08-01

    Initiating and weaning procedure of noninvasive positive pressure ventilation (NIPPV) on acute cardiogenic pulmonary edema (ACPE) has been determined empirically, and the total time of its use has been sometimes prolonged unnecessarily. A simple protocol for its use may facilitate initiation and avoids prolongation of the NIPPV treatment. We designed a step-wise protocol for NIPPV use and retrospectively examined the clinical outcome of our protocol for initiation and weaning of NIPPV in 45 patients with ACPE. Almost all patients recovered from respiratory distress successfully. There was no intubation nor complication related to NIPPV. In most of the cases, maximal-end expiratory pressure was less than 7-cm H2O. The mean duration of NIPPV was 19.5±28.0 h and the median duration was 8.0 h (interquartile range=14.0 h). This simple step-wise NIPPV protocol for ACPE can facilitate quick and safe initiation and termination of the treatment.

  12. 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.

  13. 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).

  14. 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

  15. 肾移植受者BK病毒感染的检测方法及免疫抑制方案对BK病毒活化的影响%Clinical diagnosis of BK virus infection in renal transplant recipients and influence of the immunosuppressive protocol on BKV replication

    Institute of Scientific and Technical Information of China (English)

    黄刚; 付茜; 纪玉莲; 陈立中; 王长希; 费继光; 邱江; 李军; 邓素雄; 陈国栋; 曾文涛

    2008-01-01

    目的 探讨肾移植术后受者BK病毒感染的检测方法及免疫抑制方案对BK病毒活化的影响.方法 选择1999年1月至2007年1月问进行肾移植术的200例受者为研究对象,其中100例基础免疫抑制方案为他克莫司(FK506)十霉酚酸酯(MMF)的受者作为密切观察组;另100例基础免疫抑制方案不同、但在年龄和术后是否发生急性排斥反应方面与密切观察组受者相一致(按1:1匹配)的受者作为对照观察组.在肾移植术后平均15.3个月时,分别采集所有受者的血、尿样本,行BK病毒尿沉渣Decoy细胞计数与BK病毒DNA含量的检测.分析和比较尿Decoy细胞计数、尿BK病毒含量及血BK病毒含量之间的关系;比较两组Decoy细胞、BK病毒尿症与BK病毒血症阳性率的差异.结果 200例受者的尿Decoy细胞、BK病毒尿症与病毒血症的阳性率分别为:34.0%、36.0%和16.5%.尿Decoy细胞计数与尿BK病毒含量呈正相关(r=0.714,P<0.001),但尿液和外周血中BK病毒含量无明显相关性(P>0.05).密切观察组的尿Decoy细胞、BK病毒尿症与BK病毒血症的阳性率分别为49%、50%和24%,对照观察组上述指标的阳性率分别是19%、22%和9%,两组的差异有统计学意义(P<0.01).结论 尿沉渣Decoy细胞计数方法简单、易行并敏感,可以做为BK病毒活化的指标;血、尿BK病毒DNA的检测可进一步了解病毒活化情况、筛杳BK病毒相关的移植肾肾病.FK506+MMF的组合免疫抑制方案易发生BK病毒的活化,受者术后需进行密切观察和相关的检测.%Objective To investigate the methods for clinical diagnosis of BK virus (BKV) infection and to analyze the influence of immunosuppressive protocol on BKV activation in renal transplant recipients. Methods 200 renal recipients receiving renal transplantation during 1999. 1-2007. 1 were selected as objectives, among which, 100 cases subject to FKS06 + MMF protocol were regarded as the intensive observation group

  16. 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.

  17. 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

  18. COOPERATIVE ARQ PROTOCOL FOR CORRELATED WIRELESS CHANNELS

    Institute of Scientific and Technical Information of China (English)

    Yu Guanding; Zhang Zhaoyang; Qiu Peiliang

    2006-01-01

    A novel Automatic repeat ReQuest (ARQ) protocol called cooperative ARQ is presented in this letter, where a relay terminal is requested to retransmit an erroneously received packet, instead of the source terminal. The data link layer Packet Error Rate (PER) performance of cooperative ARQ is derived in correlated wireless channel. The results show that even though the relay-destination channel is worse than the sourcedestination channel, the new protocol outperforms the traditional one as long as the average SNR of the relaydestination channel is better than a certain threshold. It is also demonstrated that a second order diversity gain can be achieved with the cooperative ARQ protocol.

  19. 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.

  20. 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...

  1. 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.

  2. Comparison of a kayaking ergometer protocol with an arm crank protocol for evaluating peak oxygen consumption.

    Science.gov (United States)

    Forbes, Scott C; Chilibeck, Philip D

    2007-11-01

    The purpose of this study was to compare a kayak ergometer protocol with an arm crank protocol for determining peak oxygen consumption (V(.-)O2). On separate days in random order, 10 men and 5 women (16-24 years old) with kayaking experience completed the kayak ergometer protocol and a standardized arm crank protocol. The kayak protocol began at 70 strokes per minute and increased by 10 strokes per minute every 2 minutes until volitional fatigue. The arm crank protocol consisted of a crank rate of 70 revolutions per minute, initial loading of 35 W and subsequent increases of 35 W every 2 minutes until volitional fatigue. The results showed a significant difference (p kayak ergometer and the arm crank protocols for relative peak V(.-)O2 (47.5 +/- 3.9 ml x kg(-1) x min(-1) vs. 44.2 +/- 6.2 ml x kg(-1) x min(-1)) and absolute peak V(.-)O2 (3.38 L x min(-1) +/- 0.53 vs. 3.14 +/- 0.64 L x min(-1)). The correlation between kayak and arm crank protocol was 0.79 and 0.90, for relative and absolute V(.-)O2 peak, respectively (both p kayak ergometer may be due to the greater muscle mass involved compared to the arm crank ergometer. The kayak ergometer protocol may therefore be more specific to the sport of kayaking than an arm crank protocol.

  3. 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.

  4. 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.

  5. Rethinking low extra delay background transport protocols

    CERN Document Server

    Carofiglio, Giovanna; Rossi, Dario; Testa, Claudio; Valenti, Silvio

    2010-01-01

    BitTorrent has recently introduced LEDBAT, a novel application-layer congestion control protocol for data exchange. The protocol design starts from the assumption that network bottlenecks are at the access of the network, and that thus user traffic competes creating self-inducing congestion. To relieve from this phenomenon, LEDBAT is designed to quickly infer that self-induced congestion is approaching (by detecting relative changes of the one-way delay in the transmission path), and to react by reducing the sending rate prior that congestion occurs. Prior work has however shown LEDBAT to be affected by a latecomer advantage, where newly arriving connections can starve already existing flows. In this work, we propose modifications to the congestion window update mechanism of the LEDBAT protocol that aim at solving this issue, guaranteeing thus intra-protocol fairness and efficiency. Closed-form expressions for the stationary throughput and queue occupancy are provided via a fluid model, whose accuracy is conf...

  6. 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...

  7. Reparable Key Distribution Protocols for Internet Environments

    Institute of Scientific and Technical Information of China (English)

    2000-01-01

    It has claimed that any practical way to achieve perfect reparability for key distribution protocol (KDP) could only be futile. Fortunately, this paper presents reparable KDPs for internet environments with the use of the concept of timestamps.

  8. Identity-based authentication protocol for grid

    Institute of Scientific and Technical Information of China (English)

    Li Hon; Sun Shixin; Yang Homiao

    2008-01-01

    Current grid authentication frameworks are achieved by applying the standard SSL authentication protocol(SAP).The authentication process is very complicated,and therefore,the grid user is in a heavily loaded point both in computation and in communication.Based on identity-based architecture for grid(IBAG)and corre-sponding encryption and signature schemes,an identity-based authentication protocol for grid is proposed.Being certificate-free,the authentication protocol aligns well with the demands of grid computing.Through simulation testing,it is seen that the authentication protocol is more lightweight and efficient than SAP,especially the more lightweight user side.This contributes to the larger grid scalability.

  9. ARC Code TI: Geometry Manipulation Protocol (GMP)

    Data.gov (United States)

    National Aeronautics and Space Administration — The Geometry Manipulation Protocol (GMP) is a library which serializes datatypes between XML and ANSI C data structures to support CFD applications. This library...

  10. Protocol to Exploit Waiting Resources for UASNs

    Directory of Open Access Journals (Sweden)

    Li-Ling Hung

    2016-03-01

    Full Text Available The transmission speed of acoustic waves in water is much slower than that of radio waves in terrestrial wireless sensor networks. Thus, the propagation delay in underwater acoustic sensor networks (UASN is much greater. Longer propagation delay leads to complicated communication and collision problems. To solve collision problems, some studies have proposed waiting mechanisms; however, long waiting mechanisms result in low bandwidth utilization. To improve throughput, this study proposes a slotted medium access control protocol to enhance bandwidth utilization in UASNs. The proposed mechanism increases communication by exploiting temporal and spatial resources that are typically idle in order to protect communication against interference. By reducing wait time, network performance and energy consumption can be improved. A performance evaluation demonstrates that when the data packets are large or sensor deployment is dense, the energy consumption of proposed protocol is less than that of existing protocols as well as the throughput is higher than that of existing protocols.

  11. Protocol to Exploit Waiting Resources for UASNs.

    Science.gov (United States)

    Hung, Li-Ling; Luo, Yung-Jeng

    2016-03-08

    The transmission speed of acoustic waves in water is much slower than that of radio waves in terrestrial wireless sensor networks. Thus, the propagation delay in underwater acoustic sensor networks (UASN) is much greater. Longer propagation delay leads to complicated communication and collision problems. To solve collision problems, some studies have proposed waiting mechanisms; however, long waiting mechanisms result in low bandwidth utilization. To improve throughput, this study proposes a slotted medium access control protocol to enhance bandwidth utilization in UASNs. The proposed mechanism increases communication by exploiting temporal and spatial resources that are typically idle in order to protect communication against interference. By reducing wait time, network performance and energy consumption can be improved. A performance evaluation demonstrates that when the data packets are large or sensor deployment is dense, the energy consumption of proposed protocol is less than that of existing protocols as well as the throughput is higher than that of existing protocols.

  12. National Wildlife Refuge System Survey Protocol Template

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This template was developed for drafting National Wildlife Refuge System (NWRS) Survey Protocols. The template is arranged in the same order as the eight basic...

  13. 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.

  14. Information Flow in Secret Sharing Protocols

    CERN Document Server

    Kashefi, Elham; Mhalla, Mehdi; Perdrix, Simon

    2009-01-01

    The entangled graph states have emerged as an elegant and powerful quantum resource, indeed almost all multiparty protocols can be written in terms of graph states including measurement based quantum computation (MBQC), error correction and secret sharing amongst others. In addition they are at the forefront in terms of implementations. As such they represent an excellent opportunity to move towards integrated protocols involving many of these elements. In this paper we look at expressing and extending graph state secret sharing and MBQC in a common framework and graphical language related to flow. We do so with two main contributions. First we express in entirely graphical terms which set of players can access which information in graph state secret sharing protocols. These succinct graphical descriptions of access allow us to take known results from graph theory to make statements on the generalisation of the previous schemes to present new secret sharing protocols. Second, we give a set of necessary condit...

  15. How To Develop Survey Protocols: A Handbook

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This handbook provides a standard and guidance for developing and reviewing survey protocols used in the National Wildlife Refuge System. In the handbook, survey...

  16. 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...

  17. Probabilistic Model--Checking of Quantum Protocols

    CERN Document Server

    Gay, S; Papanikolaou, N; Gay, Simon; Nagarajan, Rajagopal; Papanikolaou, Nikolaos

    2005-01-01

    We establish fundamental and general techniques for formal verification of quantum protocols. Quantum protocols are novel communication schemes involving the use of quantum-mechanical phenomena for representation, storage and transmission of data. As opposed to quantum computers, quantum communication systems can and have been implemented using present-day technology; therefore, the ability to model and analyse such systems rigorously is of primary importance. While current analyses of quantum protocols use a traditional mathematical approach and require considerable understanding of the underlying physics, we argue that automated verification techniques provide an elegant alternative. We demonstrate these techniques through the use of PRISM, a probabilistic model-checking tool. Our approach is conceptually simpler than existing proofs, and allows us to disambiguate protocol definitions and assess their properties. It also facilitates detailed analyses of actual implemented systems. We illustrate our techniqu...

  18. Hybrid protocol of remote implementations of quantum operations

    Science.gov (United States)

    Zhao, Ning Bo; Wang, An Min

    2007-12-01

    We propose a protocol of remote implementations of quantum operations by hybridizing bidirectional quantum-state teleportation (BQST) [Huelga , Phys. Rev. A 63, 042303 (2001)] and the Wang protocol [Wang, Phys. Rev. A 74, 032317 (2006)]. The protocol is available for remote implementations of quantum operations in the restricted sets specified in the paper. We also give a proof of the protocol and point out its optimization. As an extension, this hybrid protocol can be reduced to the BQST and Wang protocols.

  19. Adaptive Baud Protocol For Wireless Communication

    OpenAIRE

    Eskafi, F. H.; Nassiri-toussi, K.; G. Liu

    1998-01-01

    In this paper, the authors propose an algorithm that increases and decreases the transmission speed according to a user-specified function. The design objective is to regulate baud as efficiently as possible and ensure that in each transmission interval, transmitter and receiver bauds are equal for some period of time during data transmission. An equivalent discrete-time version of the protocol is verified by using the COSPAN software. Application for this adaptive baud protocol for wireless ...

  20. Quantum Key Distribution Protocol with User Authentication

    CERN Document Server

    Lee, H; Lee, D; Lim, J; Yang, H J; Lee, Hwayean; Lee, Sangjin; Lee, Donghoon; Lim, Jongin; Yang, HyungJin

    2005-01-01

    We propose a quantum key distribution protocol with quantum based user authentication. User authentication is executed by validating the correlation of GHZ states. Alice and Bob can distribute a secure key using the remaining GHZ states after authentication. This secret key does not leak even to the arbitrator by the properties of the entanglement. We will show that our protocol is secure against the cloning attack.

  1. Protocol for communications in potentially noisy environments

    Energy Technology Data Exchange (ETDEWEB)

    Boyd, Gerlad M.; Farrow, Jeffrey

    2016-02-09

    A communications protocol that is designed for transmission of data in networks that are subjected to harsh conditions is described herein. A network includes a plurality of devices, where the devices comprise respective nodes. The nodes are in communication with one another by way of a central network hub. The protocol causes the nodes to transmit data over a network bus at different data rates depending upon whether the nodes are operating normally or an arbitration procedure has been invoked.

  2. Secure Fingerprint Alignment and Matching Protocols

    OpenAIRE

    Bayatbabolghani, Fattaneh; Blanton, Marina; Aliasgari, Mehrdad; Goodrich, Michael

    2017-01-01

    We present three secure privacy-preserving protocols for fingerprint alignment and matching, based on what are considered to be the most precise and efficient fingerprint recognition algorithms-those based on the geometric matching of "landmarks" known as minutia points. Our protocols allow two or more honest-but-curious parties to compare their respective privately-held fingerprints in a secure way such that they each learn nothing more than a highly-accurate score of how well the fingerprin...

  3. Mutual Authentication Protocols for RFID Systems

    Institute of Scientific and Technical Information of China (English)

    Ashrar A. Omer; Johnson P. Thomas; Ling Zhu

    2008-01-01

    With the availability of low-cost radio frequency identification (RFID) tags, security becomes an increasing concern.However, such tags do not permit complex eryptographic functions due to their computational, communications, and storage limitations.In this paper, we investigate the security issues and requirements of RFID systems, and propose ultra-light weight and light weight protocols for low-cost RFID tags. The proposed protocols has been applied to a supply chain management system.

  4. Trust Authentication Protocol on the Web

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    It is unsuitable to use traditional identity-based authentication on the Web where entities are not foreknown to each other. Trust relationship must be established between strangers before authentication. To achieve trust authentication, the resource-constrained trust negotiation is addressed, and traditional authentication key exchange protocol is extended. Owing to avoiding the heavy computational demands the public key cryptography operations bring about, the authentication protocol is well-suited for security authentication on the Web.

  5. OAuth protocol for CERN Web Applications

    OpenAIRE

    Kleszcz, Emil; Rodriguez Fernandez, Luis; Marescaux, Nicolas Bernard

    2016-01-01

    Project Specification The CERN Authentication service has recently increased his offer of SSO protocols/frameworks with OAuth2 standard. The purpose of the work is to explain the need for an authorization standard and explain how does OAuth2 protocol addresses our requirements. OAuth is an open standard for authorization which provides a secure access to server resources that belongs to a user. As a wide known and relatively new standard (2012) is used by big players in the industry 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 computa...... the stronger fairness notion of envy-freeness. Finally, we show that under an obliviousness restriction, which still allows the computation of approximately envy-free allocations, GCC protocols are guaranteed to have exact subgame perfect Nash equilibria...

  7. Field Monitoring Protocol: Heat Pump Water Heaters

    Energy Technology Data Exchange (ETDEWEB)

    Sparn, B.; Earle, L.; Christensen, D.; Maguire, J.; Wilson, E.; Hancock, E.

    2013-02-01

    This document provides a standard field monitoring protocol for evaluating the installed performance of Heat Pump Water Heaters in residential buildings. The report is organized to be consistent with the chronology of field test planning and execution. Research questions are identified first, followed by a discussion of analysis methods, and then the details of measuring the required information are laid out. A field validation of the protocol at a house near the NREL campus is included for reference.

  8. Field Monitoring Protocol. Heat Pump Water Heaters

    Energy Technology Data Exchange (ETDEWEB)

    Sparn, B. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Earle, L. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Christensen, D. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Maguire, J. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Wilson, E. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Hancock, C. E. [Mountain Energy Partnership, Longmont, CO (United States)

    2013-02-01

    This document provides a standard field monitoring protocol for evaluating the installed performance of Heat Pump Water Heaters in residential buildings. The report is organized to be consistent with the chronology of field test planning and execution. Research questions are identified first, followed by a discussion of analysis methods, and then the details of measuring the required information are laid out. A field validation of the protocol at a house near the NREL campus is included for reference.

  9. Network-topology-adaptive quantum conference protocols

    Institute of Scientific and Technical Information of China (English)

    Zhang Sheng; Wang Jian; Tang Chao-Jing; Zhang Quan

    2011-01-01

    As an important application of the quantum network communication,quantum multiparty conference has made multiparty secret communication possible.Previous quantum multiparty conference schemes based on quantum data encryption are insensitive to network topology.However,the topology of the quantum network significantly affects the communication efficiency,e.g.,parallel transmission in a channel with limited bandwidth.We have proposed two distinctive protocols,which work in two basic network topologies with efficiency higher than the existing ones.We first present a protocol which works in the reticulate network using Greeberger-Horne-Zeilinger states and entanglement swapping.Another protocol,based on quantum multicasting with quantum data compression,which can improve the efficiency of the network,works in the star-like network.The security of our protocols is guaranteed by quantum key distribution and one-time-pad encryption.In general,the two protocols can be applied to any quantum network where the topology can be equivalently transformed to one of the two structures we propose in our protocols.

  10. Assessing an improved protocol for plasma microRNA extraction.

    Directory of Open Access Journals (Sweden)

    Inés Moret

    Full Text Available The first step in biomarkers discovery is to identify the best protocols for their purification and analysis. This issue is critical when considering peripheral blood samples (plasma and serum that are clinically interesting but meet several methodological problems, mainly complexity and low biomarker concentration. Analysis of small molecules, such as circulating microRNAs, should overcome these disadvantages. The present study describes an optimal RNA extraction method of microRNAs from human plasma samples. Different reagents and commercially available kits have been analyzed, identifying also the best pre-analytical conditions for plasma isolation. Between all of them, the column-based approaches were shown to be the most effective. In this context, miRNeasy Serum/Plasma Kit (from Qiagen rendered more concentrated RNA, that was better suited for microarrays studies and did not require extra purification steps for sample concentration and purification than phenol based extraction methods. We also present evidences that the addition of low doses of an RNA carrier before starting the extraction process improves microRNA purification while an already published carrier dose can result in significant bias over microRNA profiles. Quality controls for best protocol selection were developed by spectrophotometry measurement of contaminants and microfluidics electrophoresis (Agilent 2100 Bioanalyzer for RNA integrity. Selected donor and patient plasma samples and matched biopsies were tested by Affymetrix microarray technology to compare differentially expressed microRNAs. In summary, this study defines an optimized protocol for microRNA purification from human blood samples, increasing the performance of assays and shedding light over the best way to discover and use these biomarkers in clinical practice.

  11. EAR Protocol-Towards Fair Optimistic Non-Repudiation Exchange

    Institute of Scientific and Technical Information of China (English)

    WANG Hai-yan; WANG Ru-chuan

    2005-01-01

    Fairness is of crucial importance for the exchange protocols via Internet. Non-repudiation therefore becomes one of the vital premises, which are essential in the exchange of sensitive and important messages. This paper is to propose a new exchange protocol, termed "EAR" Exchange Protocol as it consists of three sub-protocols: Exchange sub-protocol, Abort sub-protocol and Recovery sub-protocol. It is to be argued that the incorporation of these three sub-protocols may effectively enables EAR to assure non-repudiation, strong fairness, timeliness, confidentiality and the minimized involvement of the Trusted Third Party (TTP).

  12. Security Analysis of Broadcaster Group Key Exchange Protocols

    Institute of Scientific and Technical Information of China (English)

    LI Li; ZHANG Huanguo

    2006-01-01

    Group key exchange protocols are basic protocols to provide privacy and integrity in secure group communication. This paper discusses the security of one type of group key exchange protocols and defines the kind of protocols as broadcaster group protocols. It points out two attacks on this kind of protocols. The first attack can be avoided by using fresh values in each action during one session of the group protocol. The second attack should be related with concrete application. It also proposes a dynamic key agreement protocol as an example of solutions at the last part of the paper.

  13. Analysis of different therapeutic protocols for osteonecrosis of the jaw associated with oral and intravenous bisphpsphonates

    Science.gov (United States)

    Bermúdez-Bejarano, Elena-Beatriz; Serrera-Figallo, María-Ángeles; Gutiérrez-Corrales, Aida; Romero-Ruiz, Manuel-María; Castillo-de-Oyagüe, Raquel; Gutiérrez-Pérez, José-Luis; Machuca-Portillo, Guillermo

    2017-01-01

    Introduction Chemotherapy-associated osteonecrosis of the jaw caused by bisphosphonates is an exposure of necrotic bone with more than eight weeks of evolution that is attributable to bisphosphonates and no prior radiation therapy. Its etiopathogenesis remains unknown, although there are two hypotheses that may explain it: the drug’s mechanism of action, and the risk factors that can lead to osteonecrosis. There is a wide range of treatment options for managing chemotherapy-associated osteonecrosis of the jaw, from conservative treatments to surgical procedures of varying levels of invasiveness, which are sometimes supplemented with adjuvant therapies. Objectives The objective of this article is to group the therapeutic options for osteonecrosis of the jaw (ONJ) into seven different protocols and to evaluate their effectiveness in relation to stage of ONJ. Material and Methods A literature review was carried out in PubMed following the PRISMA criteria. A total of 47 were collected after compiling a series of variables that define ONJ, applied treatments, and the clinical results obtained. Results and Discussion The 47 articles selected have a low to average estimated risk of bias and are of moderate to good quality. According to the data obtained, Protocol 3 (conservative treatment, clinical and radiological follow-up, minimally invasive surgical treatment, and adjuvant therapies) is the most favorable approach for ONJ lesions caused by oral bisphosphonates. For lesions caused by intravenous bisphosphonates, Protocol 2 (conservative treatment, clinical and radiological follow-up, minimally invasive surgical treatment, and no adjuvant therapies) is the best approach. When comparing the different stages of ONJ, Protocol 1 (conservative treatment, clinical and radiological follow-up) promotes better healing of Stage 1 ONJ lesions caused by orally administered bisphosphonates, and Protocol 3 is recommended for Stage II. For ONJ lesions attributable to intravenous

  14. Internetworking with Internet Protocol (IP) and Transmission Control Protocol (TCP) within the Military

    OpenAIRE

    Eikenberg, Bruce R.

    1990-01-01

    Approved for public release; distribution is unlimited. The backbone of the internetworking technology widely used by the military, as well as many civilian installations, is commonly referred to as TCP/IP. Transmission Control Protocol (TCP) and Internet Protocol (IP) are the two standard communication protocols from which TCP/IP receives its name. By utilizing TCP/IP, the majority of technical issues of interconnecting various computer technologies have become transparent to the user. Th...

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

    DEFF Research Database (Denmark)

    Mogensen, Martin

    2009-01-01

    Pervasive computing systems are inherently running on unstable networks and devices, subject to constant topology changes, network failures, and high churn. For this reason, pervasive computing infrastructures need to handle these issues as part of their design. This is, however, not feasible...... 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...... is lower complexity of building pervasive systems and higher robustness....

  16. The pitfalls of protocols - a case of postpartum splenic artery aneurysm rupture.

    Science.gov (United States)

    Thomson, M J; Seshadri, S; Swami, S; Strandvik, G F; Neales, K

    2010-07-21

    The authors present a case of splenic artery aneurysm rupture, which neatly illustrates some of the problems of modern medical practice and the potential detriment of blind adherence to protocol driven care, without adequate reflection on the whole clinical picture and possible alternative diagnoses.

  17. The pitfalls of protocols – a case of postpartum splenic artery aneurysm rupture

    OpenAIRE

    Thomson, M. J.; Seshadri, S; S. Swami; Strandvik, G F; Neales, K

    2010-01-01

    The authors present a case of splenic artery aneurysm rupture, which neatly illustrates some of the problems of modern medical practice and the potential detriment of blind adherence to protocol driven care, without adequate reflection on the whole clinical picture and possible alternative diagnoses.

  18. Short versus Long Gonadotropin-Releasing Hormone Analogue Suppression Protocols in IVF/ICSI Cycles in Patients of Various Age Ranges.

    Directory of Open Access Journals (Sweden)

    Jianping Ou

    Full Text Available To compare the two GnRH-a protocols (long GnRH-a protocol and short GnRH-a protocol for ovarian stimulation in IVF/ICSI cycles in patients of various age ranges.A total of 5662 IVF-ET/ICSI cycles from 2010 to 2013 were retrospectively identified. The cycles were divided into two groups: a long protocol group and short protocol group. In each group, the patients were divided into four age ranges: 40 years. The duration of stimulation, total dose of Gn, implantation rate and pregnancy rate were compared.The total dose of Gn was significantly higher, and the duration of stimulation was significantly longer, in the long protocol group than in the short protocol group for all age ranges (P<0.05. If the patients were of the same age range, the number of oocytes retrieved, MII oocytes, and high-quality embryos in the long protocol group were all significantly greater than those in the short protocol group (P<0.05. In the long protocol group, the clinical pregnancy rates of the four age ranges were 52.76%, 44.33%, 36.15% and 13.33%, respectively, which were significantly higher than those in the short protocol group (33.33%, 24.58%, 22.49% and 8.72%, respectively; P<0.05. The same trend was also found in the implantation rates of the four age ranges. As the age increased, the clinical pregnancy and implantation rates, as well as the number of oocytes retrieved, MII oocytes, and high-quality embryos, of the long protocol group significantly decreased (P<0.05.Our study demonstrated that regardless of patient age, the long protocol was superior to the short protocol in terms of the number of retrieved oocytes, as well as the implantation and pregnancy rates.

  19. Simulation and Evaluation of CTP and Secure-CTP Protocols

    Directory of Open Access Journals (Sweden)

    P. Pecho

    2010-04-01

    Full Text Available The paper discusses characteristics and qualities of two routing protocols – Collection Tree Protocol and its secure modification. The original protocol, as well as other protocols for wireless sensors, solves only problems of ra- dio communication and limited resources. Our design of the secure protocol tries to solve also the essential security ob- jectives. For the evaluation of properties of our protocol in large networks, a TOSSIM simulator was used. Our effort was to show the influence of the modification of the routing protocol to its behavior and quality of routing trees. We have proved that adding security into protocol design does not necessarily mean higher demands for data transfer, power consumption or worse protocol efficiency. In the paper, we manifest that security in the protocol may be achieved with low cost and may offer similar performance as the original protocol.

  20. Managing symptoms during cancer treatments: evaluating the implementation of evidence-informed remote support protocols

    Directory of Open Access Journals (Sweden)

    Stacey Dawn

    2012-11-01

    Full Text Available Abstract Background Management of cancer treatment-related symptoms is an important safety issue given that symptoms can become life-threatening and often occur when patients are at home. With funding from the Canadian Partnership Against Cancer, a pan-Canadian steering committee was established with representation from eight provinces to develop symptom protocols using a rigorous methodology (CAN-IMPLEMENT©. Each protocol is based on a systematic review of the literature to identify relevant clinical practice guidelines. Protocols were validated by cancer nurses from across Canada. The aim of this study is to build an effective and sustainable approach for implementing evidence-informed protocols for nurses to use when providing remote symptom assessment, triage, and guidance in self-management for patients experiencing symptoms while undergoing cancer treatments. Methods A prospective mixed-methods study design will be used. Guided by the Knowledge to Action Framework, the study will involve (a establishing an advisory knowledge user team in each of three targeted settings; (b assessing factors influencing nurses’ use of protocols using interviews/focus groups and a standardized survey instrument; (c adapting protocols for local use, ensuring fidelity of the content; (d selecting intervention strategies to overcome known barriers and implementing the protocols; (e conducting think-aloud usability testing; (f evaluating protocol use and outcomes by conducting an audit of 100 randomly selected charts at each of the three settings; and (g assessing satisfaction with remote support using symptom protocols and change in nurses’ barriers to use using survey instruments. The primary outcome is sustained use of the protocols, defined as use in 75% of the calls. Descriptive analysis will be conducted for the barriers, use of protocols, and chart audit outcomes. Content analysis will be conducted on interviews/focus groups and usability testing