Problematic protocols: An overview of medical research protocols not approved by the LUMC medical ethics review committee.

PubMed

Tersmette, Derek Gideon; Engberts, Dirk Peter

2017-01-01

The Committee for Medical Ethics (CME) of Leiden University Medical Center (LUMC) was established as the first medical ethics reviewing committee (MREC) in the Netherlands. In the period 2000-2010 the CME received 2,162 protocols for review. Some of these protocols were never approved. Until now, there has existed neither an overview of these failed protocols nor an overview of the reasons for their failure. This report draws on data from the digital database, the physical archives, and the minutes of the meetings of the CME. Additional information has been obtained from the Central Committee on Research involving Human Subjects (CCRH) and survey-based research. Protocols were itemized based on characteristic features and their reviewing procedures were analyzed. In total, 1,952 out of 2,162 research protocols submitted during 2000-2010 (90.3%) were approved by the CME; 210 of 2,162 protocols (9.7%) were not approved. Of these 210 protocols, 177 failed due to reasons not related to CME reviewing. In 15 cases CME reviewing led to protocol failure, while another 10 protocols were rejected outright. Eight of the 210 submitted protocols without approval had been conducted prior to submission. In the aforementioned period, little protocol failure occurred. For the most part, protocol failure was caused by problems that are not CME related. This type of failure has several identifiable factors, none of which have anything to do with the ethical reviewing procedure by the CME. A mere 1.2% of protocols failed due to ethical review. Unacceptable burden and risks to the subject and an inadequate methodology are the most common reasons for this CME-related protocol failure.

[The importance of defining methodology for post-marketing observational studies on cardiovascular therapies].

PubMed

Pelliccia, Francesco; Barillà, Francesco; Tanzilli, Gaetano; Viceconte, Nicola; Paravati, Vincenzo; Mangieri, Enrico; Gaudio, Carlo

2017-01-01

In recent years, a growing number of observational studies in cardiology have been carried out following the criticism that rigid design of randomized clinical trials produces information that is not applicable to the general patient. This approach is very common in several branches of medicine, first of all oncology, but has often been considered marginal in cardiology. The recent introduction of new oral anticoagulants (NOACs) on the market, however, has seen a proliferation of "real-life" studies, drawing the attention of cardiologists to the advantages and limitations of post-marketing studies. NOACs have been approved for use on the basis of large randomized clinical trials that have clearly documented their efficacy and safety. Since they have become available, the analysis of phase IV data has been considered crucial and therefore a great amount of information on the use of NOACs in daily practice has become available. It should be considered, however, that the possibility exists that results obtained from "real-world" studies, which do not apply rigid scientific criteria, may lead to incorrect conclusions. Accordingly, it is mandatory to fully define the operational standards of observational studies. All the protagonists of post-marketing analysis (physicians, epidemiologists, pharmacologists, statisticians) should handle the data strictly in order to ensure their reliability and comparability with other studies. To this end, it is crucial that researchers follow rigorous operational protocols for phase IV studies. Briefly, any "real-life" study should be prospective and adhere to what is prespecified by the research protocol - which must illustrate the background and rationale of the study, define its primary endpoint, and detail the methods, i.e. study design, population and variables.

Research ethics board approval for an international thromboprophylaxis trial.

PubMed

Lutz, Kristina; Wilton, Kelly; Zytaruk, Nicole; Julien, Lisa; Hall, Richard; Harvey, Johanne; Skrobik, Yoanna; Vlahakis, Nicholas; Meade, Laurie; Matte, Andrea; Meade, Maureen; Burns, Karen; Albert, Martin; Cash, Bronwyn Barlow; Vallance, Shirley; Klinger, James; Heels-Ansdell, Diane; Cook, Deborah

2012-06-01

Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards. Copyright © 2012 Elsevier Inc. All rights reserved.

Treating Gulf War Illness with Novel Anti-Inflammatories: A Screening of Botantical Microglia Modulators

DTIC Science & Technology

2016-10-01

approval and initiated advertising , recruitment, participant screening, participant enrollment, and the study protocol. All start up subtasks have been...be made to enroll these during the next reporting period. Advertisement , recruitment, screening, and enrollment are ongoing as we work toward the...Regulatory Approvals 100% Completed. • Task 3: Start up 100% Completed. Milestone: Protocol ready to begin—Completed • Task 4: Advertisement 40

A question of authority

DOE Office of Scientific and Technical Information (OSTI.GOV)

Morgan, Earl W.

A Question of Authority. This article deals with a certain scenario and several reviewers are to give their opinion. This one is in regards to - Suspending an IACUC approved animal use activity is about the last thing a research institution wants to do. Consider the predicament that the Great Eastern University IACUC faced when Dr. Janet Jenkins, the Attending Veterinarian, suspended all animal use activity on an approved protocol of Dr. Roy Maslo. Jenkins had the IACUCs authority to temporarily suspend a protocol, subject to review by a quorum of the full committee. She alleged that Maslo used micemore » from his breeding colony, not purchased rats, to begin a new study. Jenkins saw Maslos technicians bringing mouse cages to a procedure room and setting up for a minor survival surgery. She asked them to wait until she clarified things as she felt confident that the protocol called for rats. She called Maslo and asked him if the study had been approved for mice, to which he responded affirmatively. Still not feeling quite assured, she went to her office, reviewed the protocol, and found only rat studies described. She also called the IACUC office to see if there were any approved amendments which she may not have received, and was told that there were none. By the time she returned, one procedure was completed. Understandably upset, she informed the technicians and Maslo that any further activity on the protocol was suspended until the issue was resolved. Jenkins informed the IACUC chairman who in turned called an emergency meeting of the committee.« less

Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners.

PubMed Central

Wise, P.; Drury, M.

1996-01-01

OBJECTIVE: To assess the outcome of 100 general practice based, multicentre research projects submitted to the ethics committee of the Royal College of General Practitioners by pharmaceutical companies or their agents between 1984 and 1989. DESIGN: Analysis of consecutive submitted protocols for stated objectives, study design, and outcomes; detailed review of committee minutes and correspondence in relation to amendment and approval; assessment of final reports submitted at conclusion of studies. SUBJECTS: 82 finally approved protocols, embracing 34,523 proposed trial subjects and 1195 proposed general practice investigators. MAIN OUTCOME MEASURES: Success at enrolling subjects and investigators; commencement and completion data; validity of final report's assessment of efficacy, safety, tolerability, and acceptability; and method of use and dissemination of findings. RESULTS: 18 studies were not approved and 45 had to be amended. Randomised controlled trials comprised 46 of the original submissions. Remuneration considerations, inadequate information or consent sheets, pregnancy safety, the need to discontinue existing therapy, and suboptimal scientific content were major reasons for rejecting studies or asking for amendments. Of the 82 approved studies 8 were not started. Shortfalls of investigators (of 39%) and trial subjects (of 37%) and an overall 23% withdrawal rate were responsible for a significant incidence of inconclusive results. Within the six year follow up interval, only 19 of the studies had been formally published. CONCLUSIONS: This audit identified substantial ethical concerns in the process of approving multicentre general practice pharmaceutical research. PMID:8939118

Comparison of Outcomes before and after Ohio's Law Mandating Use of the FDA-Approved Protocol for Medication Abortion: A Retrospective Cohort Study.

PubMed

Upadhyay, Ushma D; Johns, Nicole E; Combellick, Sarah L; Kohn, Julia E; Keder, Lisa M; Roberts, Sarah C M

2016-08-01

In February 2011, an Ohio law took effect mandating use of the United States Food and Drug Administration (FDA)-approved protocol for mifepristone, which is used with misoprostol for medication abortion. Other state legislatures have passed or enacted similar laws requiring use of the FDA-approved protocol for medication abortion. The objective of this study is to examine the association of this legal change with medication abortion outcomes and utilization. We used a retrospective cohort design, comparing outcomes of medication abortion patients in the prelaw period to those in the postlaw period. Sociodemographic and clinical chart data were abstracted from all medication abortion patients from 1 y prior to the law's implementation (January 2010-January 2011) to 3 y post implementation (February 2011-October 2014) at four abortion-providing health care facilities in Ohio. Outcome data were analyzed for all women undergoing abortion at ≤49 d gestation during the study period. The main outcomes were as follows: need for additional intervention following medication abortion (such as aspiration, repeat misoprostol, and blood transfusion), frequency of continuing pregnancy, reports of side effects, and the proportion of abortions that were medication abortions (versus other abortion procedures). Among the 2,783 medication abortions ≤49 d gestation, 4.9% (95% CI: 3.7%-6.2%) in the prelaw and 14.3% (95% CI: 12.6%-16.0%) in the postlaw period required one or more additional interventions. Women obtaining a medication abortion in the postlaw period had three times the odds of requiring an additional intervention as women in the prelaw period (adjusted odds ratio [AOR] = 3.11, 95% CI: 2.27-4.27). In a mixed effects multivariable model that uses facility-months as the unit of analysis to account for lack of independence by site, we found that the law change was associated with a 9.4% (95% CI: 4.0%-18.4%) absolute increase in the rate of requiring an additional intervention. The most common subsequent intervention in both periods was an additional misoprostol dose and was most commonly administered to treat incomplete abortion. The percentage of women requiring two or more follow-up visits increased from 4.2% (95% CI: 3.0%-5.3%) in the prelaw period to 6.2% (95% CI: 5.5%-8.0%) in the postlaw period (p = 0.003). Continuing pregnancy was rare (0.3%). Overall, 12.6% of women reported at least one side effect during their medication abortion: 8.4% (95% CI: 6.8%-10.0%) in the prelaw period and 15.6% (95% CI: 13.8%-17.3%) in the postlaw period (p < 0.001). Medication abortions fell from 22% (95% CI: 20.8%-22.3%) of all abortions the year before the law went into effect (2010) to 5% (95% CI: 4.8%-5.6%) 3 y after (2014) (p < 0.001). The average patient charge increased from US$426 in 2010 to US$551 in 2014, representing a 16% increase after adjusting for inflation in medical prices. The primary limitation to the study is that it was a pre/post-observational study with no control group that was not exposed to the law. Ohio law required use of a medication abortion protocol that is associated with a greater need for additional intervention, more visits, more side effects, and higher costs for women relative to the evidence-based protocol. There is no evidence that the change in law led to improved abortion outcomes. Indeed, our findings suggest the opposite. In March 2016, the FDA-protocol was updated, so Ohio providers may now legally provide current evidence-based protocols. However, this law is still in place and bans physicians from using mifepristone based on any new developments in clinical research as best practices continue to be updated.

Tiered protocol implementation improves treatment of hypoglycaemia in a neurosciences critical care and surgical intensive care unit.

PubMed

Van Berkel, Megan A; MacDermott, Jennifer; Dungan, Kathleen M; Cook, Charles H; Murphy, Claire V

2017-12-01

Although studies demonstrate techniques to limit hypoglycaemia in critically ill patients, there are limited data supporting methods to improve management of existing hypoglycaemia. Assess the impact and sustainability of a computerised, three tiered, nurse driven protocol for hypoglycaemia treatment. Retrospective pre and post protocol study. Neurosciences and surgical intensive care units at a tertiary academic medical centre. Patients with a hypoglycaemic episode were included during a pre-protocol or post-protocol implementation period. An additional six-month cohort was evaluated to assess sustainability. Fifty-four patients were included for evaluation (35 pre- and 19 post-protocol); 122 patients were included in the sustainability cohort. Hypoglycaemia treatment significantly improved in the post-protocol cohort (20% vs. 52.6%, p=0.014); with additional improvement to 79.5% in the sustainability cohort. Time to follow-up blood glucose was decreased after treatment from 122 [Q1-Q3: 46-242] minutes pre-protocol to 25 [Q1-Q3: 9-48] minutes post protocol (p<0.0001). This reduction was maintained in the sustainability cohort [median of 29min (Q1-Q3: 20-51)]. Implementation of a nurse-driven, three-tiered protocol for treatment of hypoglyacemia significantly improved treatment rates, as well as reduced time to recheck blood glucose measurement. These benefits were sustained during a six-month period after protocol implementation. Copyright © 2017 Elsevier Ltd. All rights reserved.

Basic Microsurgery Training Using the Laboratory Rat (Rattus norvegicus)

DTIC Science & Technology

2017-03-23

CHANGES: Have there been any personnel/staffing changes (PI/CI/ AI /TC/lnstructor) since the last IACUC approval of protocol, or annual review? _X_ Yes No If...Include Name, Protocol function - PI/CI/ AI /TC/lnstructor, IACUC approval -Yes/No) Maj Ryan Diepenbrock (PI) IACUC Approval Yes 18Jun 15 DELETIONS...Include Name, Protocol function - PI/CI/ AI /TC/lnstructor, Effective date of deletion) Lt Col Jean Luc Niel (PI) June 2015 Col Bradley Turner (Al)July

The Myth, the Truth, the NASA IRB

NASA Technical Reports Server (NTRS)

Covington, M. D.; Flores, M. P.; Neutzler, V. P.; Schlegel, T. T.; Platts, S. H.; Lioyd, C. W.

2017-01-01

The purpose of the NASA Institutional Review Board (IRB) is to review research activities involving human subjects to ensure that ethical standards for the care and protection of human subjects have been met and research activities are in compliance with all pertinent federal, state and local regulations as well as NASA policies. NASA IRB's primary role is the protection of human subjects in research studies. Protection of human subjects is the shared responsibility of NASA, the IRB, and the scientific investigators. Science investigators who plan to conduct NASA-funded human research involving NASA investigators, facilities, or funds must submit and coordinate their research studies for review and approval by the NASA IRB prior to initiation. The IRB has the authority to approve, require changes in, or disapprove research involving human subjects. Better knowledge of the NASA IRB policies, procedures and guidelines should help facilitate research protocol applications and approvals. In this presentation, the myths and truths of NASA IRB policies and procedures will be discussed. We will focus on the policies that guide a protocol through the NASA IRB and the procedures that principal investigators must take to obtain required IRB approvals for their research studies. In addition, tips to help ensure a more efficient IRB review will be provided. By understanding the requirements and processes, investigators will be able to more efficiently prepare their protocols and obtain the required NASA IRB approval in a timely manner.

Evaluation of post-authorization safety studies in the first cohort of EU Risk Management Plans at time of regulatory approval.

PubMed

Giezen, Thijs J; Mantel-Teeuwisse, Aukje K; Straus, Sabine M J M; Egberts, Toine C G; Blackburn, Stella; Persson, Ingemar; Leufkens, Hubert G M

2009-01-01

Since November 2005, an EU Risk Management Plan (EU-RMP) has had to be submitted as part of a marketing application for all new chemical entities in the EU. In the EU-RMP, the safety profile of the medicine has to be described and pharmacovigilance activities should be proposed to study further safety concerns during use of the drug in the real-world setting. These activities include, for example, collection of spontaneously reported adverse events and post-authorization safety studies (PASS). Since the submission of an EU-RMP is a relatively new requirement, there is limited knowledge on the quality and completeness of the study protocols of PASS at the time of approval and there are no data on the influence of certain drug characteristics on the proposed pharmacovigilance activities. To examine the types of proposed pharmacovigilance activities in a sample of EU-RMPs, describe and evaluate the methodology of PASS, identify problems and propose remedies, and compare characteristics between biologicals and small molecules. Eighteen EU-RMPs (nine for biologicals, nine for small molecules) given a positive decision regarding the marketing application by the Committee for Medicinal Products for Human Use between November 2005 and May 2007 were included in this descriptive cohort study. The EU-RMPs were selected over time and different therapeutic areas. Classification of the safety concerns ('important identified risks', 'important potential risks', 'important missing information' within the EU-RMP was studied. For PASS, data source (registry, population-based database, sponsor-owned clinical trial database), source of study population to be included in PASS and comprehensiveness of study protocol (full protocol, limited protocol, study synopsis, short description, commitment without further information) were studied. Compared to small molecules, safety concerns for biologicals were less frequently classified as important identified risks (relative risk [RR] 0.6; 95% CI 0.3, 1.0) and more frequently as important missing information (RR 1.6; 95% CI 1.0, 2.7). Forty-seven PASS were proposed; 31 for biologicals and 16 for small molecules. Compared with studies proposed in population-based databases (4 for biologicals, 8 for small molecules), studies in registries (18 for biologicals, 4 for small molecules) were more frequently proposed for biologicals than for small molecules (RR 2.5; 95% CI 1.1, 5.7). About 60% of the proposed PASS will include EU inhabitants. No full study protocols were submitted; 26% involved a limited study protocol, 33% a study synopsis, 37% a short description and 4% a commitment without further information. Approximately 40% of the study proposals for PASS were classified as a short description or a commitment to perform a study without further information, precluding an adequate scientific assessment. Studying non-EU populations may give rise to difficulties with generalizability of the results to the EU due to differences in patient characteristics, differences in the indication for the medicine and different healthcare systems. This study emphasizes the need for more complete study proposals to be submitted earlier on in the evaluation period and for the inclusion of EU inhabitants in PASS. In addition, differences in the characteristics between biologicals and small molecules, e.g. in the data source proposed, support the need for individualized tailored PASS depending on the type of drug.

Site Variability in Regulatory Oversight for an International Study of Pediatric Sepsis.

PubMed

Michelson, Kelly N; Reubenson, Gary; Weiss, Scott L; Fitzgerald, Julie C; Ackerman, Kate K; Christie, LeeAnn; Bush, Jenny L; Nadkarni, Vinay M; Thomas, Neal J; Schreiner, Mark S

2018-04-01

Duplicative institutional review board/research ethics committee review for multicenter studies may impose administrative burdens and inefficiencies affecting study implementation and quality. Understanding variability in site-specific institutional review board/research ethics committee assessment and barriers to using a single review committee (an increasingly proposed solution) can inform a more efficient process. We provide needed data about the regulatory oversight process for the Sepsis PRevalence, OUtcomes, and Therapies multicenter point prevalence study. Survey. Sites invited to participate in Sepsis PRevalence, OUtcomes, and Therapies. Investigators at sites that expressed interest and/or participated in Sepsis PRevalence, OUtcomes, and Therapies. None. Using an electronic survey, we collected data about 1) logistics of protocol submission, 2) institutional review board/research ethics committee requested modifications, and 3) use of a single institutional review board (for U.S. sites). We collected surveys from 104 of 167 sites (62%). Of the 97 sites that submitted the protocol for institutional review board/research ethics committee review, 34% conducted full board review, 54% expedited review, and 4% considered the study exempt. Time to institutional review board/research ethics committee approval required a median of 34 (range 3-186) days, which took longer at sites that required protocol modifications (median [interquartile range] 50 d [35-131 d] vs 32 d [14-54 d)]; p = 0.02). Enrollment was delayed at eight sites due to prolonged (> 50 d) time to approval. Of 49 U.S. sites, 43% considered using a single institutional review board, but only 18% utilized this option. Time to final approval for U.S. sites using the single institutional review board was 62 days (interquartile range, 34-70 d) compared with 34 days (interquartile range, 15-54 d) for nonsingle institutional review board sites (p = 0.16). Variability in regulatory oversight was evident for this minimal-risk observational research study, most notably in the category of type of review conducted. Duplicative review prolonged time to protocol approval at some sites. Use of a single institutional review board for U.S. sites was rare and did not improve efficiency of protocol approval. Suggestions for minimizing these challenges are provided.

Development and implementation of clinical trial protocol templates at the National Institute of Allergy and Infectious Diseases.

PubMed

Bridge, Heather; Smolskis, Mary; Bianchine, Peter; Dixon, Dennis O; Kelly, Grace; Herpin, Betsey; Tavel, Jorge

2009-08-01

A clinical research protocol document must reflect both sound scientific rationale as well as local, national and, when applicable, international regulatory and human subject protections requirements. These requirements originate from a variety of sources, undergo frequent revision and are subject to interpretation. Tools to assist clinical investigators in the production of clinical protocols could facilitate navigating these requirements and ultimately increase the efficiency of clinical research. The National Institute of Allergy and Infectious Diseases (NIAID) developed templates for investigators to serve as the foundation for protocol development. These protocol templates are designed as tools to support investigators in developing clinical protocols. NIAID established a series of working groups to determine how to improve its capacity to conduct clinical research more efficiently and effectively. The Protocol Template Working Group was convened to determine what protocol templates currently existed within NIAID and whether standard NIAID protocol templates should be produced. After review and assessment of existing protocol documents and requirements, the group reached consensus about required and optional content, determined the format and identified methods for distribution as well as education of investigators in the use of these templates. The templates were approved by the NIAID Executive Committee in 2006 and posted as part of the NIAID Clinical Research Toolkit [1] website for broad access. These documents require scheduled revisions to stay current with regulatory and policy changes. The structure of any clinical protocol template, whether comprehensive or specific to a particular study phase, setting or design, affects how it is used by investigators. Each structure presents its own set of advantages and disadvantages. While useful, protocol templates are not stand-alone tools for creating an optimal protocol document, but must be complemented by institutional resources and support. Education and guidance of investigators in the appropriate use of templates is necessary to ensure a complete yet concise protocol document. Due to changing regulatory requirements, clinical protocol templates cannot become static, but require frequent revisions.

Evaluation of the impact of support for nursing research on scientific productivity in seven Italian hospitals: A multiple interrupted time series study.

PubMed

Chiari, Paolo; Forni, Cristiana; Zeneli, Anita; Gianesini, Gloria; Zanin, Roberta; Braglia, Luca; Cavuto, Silvio; Guberti, Monica

2016-05-01

Nursing research is not well-developed in Italy, and knowledge of the methodologies for conducting research is lacking. In several hospitals, including those in which this study was conducted, a research center has been established to support and educate nurses on how to conduct clinical research. In this observational study, we sought to assess whether establishing a support center for nursing research has resulted in an increase in scientific production in terms of the numbers of protocols approved (primary outcome), articles published and nurse authors involved in the publications (secondary outcomes). Multiple interrupted time series. Data from 2002 to 2012 were collected in seven hospitals. Research centers have been established at various times in only four of these hospitals. A statistically significant increase in the primary outcome (the number of protocols approved by the Research Ethics Committee in which the principal investigator was a nurse) was observed in two hospitals approximately 2years after establishing a research center. The number of nursing research articles published in scientific journals with an impact factor increased but was not statistically significant. Finally, the number of nurse authors increased significantly in two hospitals with support units. Definitive conclusions could not be reached for the other two experimental hospitals because notably few post-intervention data were available. In the control hospitals, the scientific production outcomes did not change. This study shows that establishing a support center for nursing research inside hospitals can facilitate the production of research. Copyright © 2016 Elsevier Ltd. All rights reserved.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

PubMed

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

PubMed Central

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

Background In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA’s pre-market approval (PMA) pathway. Methods and results We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. PMID:26060416

Guided internet-administered self-help to reduce symptoms of anxiety and depression among adolescents and young adults diagnosed with cancer during adolescence (U-CARE: YoungCan): a study protocol for a feasibility trial.

PubMed

Ander, Malin; Wikman, Anna; Ljótsson, Brjánn; Grönqvist, Helena; Ljungman, Gustaf; Woodford, Joanne; Lindahl Norberg, Annika; von Essen, Louise

2017-01-27

A subgroup of adolescents and young adults diagnosed with cancer during adolescence reports elevated levels of anxiety and depressive symptoms and unmet needs for psychological support. Evidence-based psychological treatments tailored for this population are lacking. This protocol describes a feasibility study of a guided-internet-administered self-help programme (YoungCan) primarily targeting symptoms of anxiety and depression among young persons diagnosed with cancer during adolescence and of the planned study procedures for a future controlled trial. The study is an uncontrolled feasibility trial with a pre-post and 3-month follow-up design. Potential participants aged 15-25 years, diagnosed with cancer during adolescence, will be identified via the Swedish Childhood Cancer Registry. 30 participants will be included. Participants will receive YoungCan, a 12-week therapist-guided, internet-administered self-help programme consisting primarily of cognitive-behavioural therapy organised into individually assigned modules targeting depressive symptoms, worry and anxiety, body dissatisfaction and post-traumatic stress. Interactive peer support and psychoeducative functions are also available. Feasibility outcomes include: recruitment and eligibility criteria; data collection; attrition; resources needed to complete the study and programme; safety procedures; participants' and therapists' adherence to the programme; and participants' acceptability of the programme and study methodology. Additionally, mechanisms of impact will be explored and data regarding symptoms of anxiety, depression, post-traumatic stress, body dissatisfaction, reactions to social interactions, quality of life, axis I diagnoses according to the Mini International Neuropsychiatric Interview and healthcare service use will be collected. Exploratory analyses of changes in targeted outcomes will be conducted. This feasibility protocol was approved by the Regional Ethical Review Board in Uppsala, Sweden (ref: 2016/210). Findings will be disseminated to relevant research, clinical, health service and patient communities through publications in peer-reviewed and popular science journals and presentations at scientific and clinical conferences. ISRCTN97835363. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

77 FR 62449 - Approval and Promulgation of Implementation Plans; Alabama; Disapproval of 110(a)(2)(E)(ii...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-15

... in their comment that EPA approve a conflict of interest protocol submitted for inclusion in the SIP... that with the inclusion of this protocol in the SIP, EPA would be able to approve Alabama's 1997 annual... the State Implementation Plan (SIP) submissions, submitted by the State of Alabama, through the...

Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter pediatric clinical trials.

PubMed

Kimberly, Michael B; Hoehn, K Sarah; Feudtner, Chris; Nelson, Robert M; Schreiner, Mark

2006-05-01

To systematically compare standards for compensation and child participant assent in informed permission, assent, and consent forms (IP-A-CFs) approved by 55 local institutional review boards (IRBs) reviewing 3 standardized multicenter research protocols. Sixty-nine principal investigators participating in any of 3 national, multicenter clinical trials submitted standardized research protocols for their trials to their local IRBs for approval. Copies of the subsequently IRB-approved IP-A-CFs were then forwarded to an academic clinical research organization. This collection of IRB-approved forms allowed for a quasiexperimental retrospective evaluation of the variation in informed permission, assent, and consent standards operationalized by the local IRBs. Standards for compensation and child participant assent varied substantially across 69 IRB-approved IP-A-CFs. Among the 48 IP-A-CFs offering compensation, monetary compensation was offered by 33 as reimbursement for travel, parking, or food expenses, whereas monetary or material compensation was offered by 22 for subject inconvenience and by 13 for subject time. Compensation ranged widely within and across studies (study 1, $180-1425; study 2, $0-500; and study 3, $0-100). Regarding child participant assent, among the 57 IP-A-CFs that included a form of assent documentation, 33 included a line for assent on the informed permission or consent form, whereas 35 included a separate form written in simplified language. Of the IP-A-CFs that stipulated the documentation of assent, 31 specified > or =1 age ranges for obtaining assent. Informed permission or consent forms were addressed either to parents or child participants. In response to identical clinical trial protocols, local IRBs generate IP-A-CFs that vary considerably regarding compensation and child participant assent.

Clinical outcomes and mortality before and after implementation of a pediatric sepsis protocol in a limited resource setting: A retrospective cohort study in Bangladesh.

PubMed

Kortz, Teresa Bleakly; Axelrod, David M; Chisti, Mohammod J; Kache, Saraswati

2017-01-01

Pediatric sepsis has a high mortality rate in limited resource settings. Sepsis protocols have been shown to be a cost-effective strategy to improve morbidity and mortality in a variety of populations and settings. At Dhaka Hospital in Bangladesh, mortality from pediatric sepsis in high-risk children previously approached 60%, which prompted the implementation of an evidenced-based protocol in 2010. The clinical effectiveness of this protocol had not been measured. We hypothesized that implementation of a pediatric sepsis protocol improved clinical outcomes, including reducing mortality and length of hospital stay. This was a retrospective cohort study of children 1-59 months old with a diagnosis of sepsis, severe sepsis or septic shock admitted to Dhaka Hospital from 10/25/2009-10/25/2011. The primary outcome was inpatient mortality pre- and post-protocol implementation. Secondary outcomes included fluid overload, heart failure, respiratory insufficiency, length of hospital stay, and protocol compliance, as measured by antibiotic and fluid bolus administration within 60 minutes of hospital presentation. 404 patients were identified by a key-word search of the electronic medical record; 328 patients with a primary diagnosis of sepsis, severe sepsis, or septic shock were included (143 pre- and185 post-protocol) in the analysis. Pre- and post-protocol mortality were similar and not statistically significant (32.17% vs. 34.59%, p = 0.72). The adjusted odds ratio (AOR) for post-protocol mortality was 1.55 (95% CI, 0.88-2.71). The odds for developing fluid overload were significantly higher post-protocol (AOR 3.45, 95% CI, 2.04-5.85), as were the odds of developing heart failure (AOR 4.52, 95% CI, 1.43-14.29) and having a longer median length of stay (AOR 1.81, 95% CI 1.10-2.96). There was no statistically significant difference in respiratory insufficiency (pre- 65.7% vs. post- 70.3%, p = 0.4) or antibiotic administration between the cohorts (pre- 16.08% vs. post- 12.43%, p = 0.42). Implementation of a pediatric sepsis protocol did not improve all-cause mortality or length of stay and may have been associated with increased fluid overload and heart failure during the study period in a large, non-governmental hospital in Bangladesh. Similar rates of early antibiotic administration may indicate poor protocol compliance. Though evidenced-based protocols are a potential cost-effective strategy to improve outcomes, future studies should focus on optimal implementation of context-relevant sepsis protocols in limited resource settings.

30 CFR 15.10 - Post-approval product audit.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Post-approval product audit. 15.10 Section 15... General Provisions § 15.10 Post-approval product audit. (a) Approved explosives and sheathed explosive... observe any tests conducted during this audit. (c) An approved explosive or sheathed explosive unit shall...

23 CFR 1340.11 - Post-approval alterations to survey design.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 23 Highways 1 2012-04-01 2012-04-01 false Post-approval alterations to survey design. 1340.11... Post-approval alterations to survey design. After NHTSA approval of a survey design, States shall submit for NHTSA approval any proposed alteration to their survey design, including, but not limited to...

23 CFR 1340.11 - Post-approval alterations to survey design.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 23 Highways 1 2013-04-01 2013-04-01 false Post-approval alterations to survey design. 1340.11... Post-approval alterations to survey design. After NHTSA approval of a survey design, States shall submit for NHTSA approval any proposed alteration to their survey design, including, but not limited to...

23 CFR 1340.11 - Post-approval alterations to survey design.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 23 Highways 1 2014-04-01 2014-04-01 false Post-approval alterations to survey design. 1340.11... Post-approval alterations to survey design. After NHTSA approval of a survey design, States shall submit for NHTSA approval any proposed alteration to their survey design, including, but not limited to...

30 CFR 7.8 - Post-approval product audit.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Post-approval product audit. 7.8 Section 7.8... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.8 Post-approval product audit...-holder may observe any tests conducted during this audit. (c) An approved product shall be subject to...

30 CFR 250.282 - Do I have to conduct post-approval monitoring?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Do I have to conduct post-approval monitoring... OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and Information Post-Approval Requirements for the Ep, Dpp, and Docd § 250.282 Do I have to conduct post-approval monitoring...

Antibiotic stewardship in the newborn surgical patient: A quality improvement project in the neonatal intensive care unit.

PubMed

Walker, Sarah; Datta, Ankur; Massoumi, Roxanne L; Gross, Erica R; Uhing, Michael; Arca, Marjorie J

2017-12-01

There is significant diversity in the utilization of antibiotics for neonates undergoing surgical procedures. Our institution standardized antibiotic administration for surgical neonates, in which no empiric antibiotics were given to infants with surgical conditions postnatally, and antibiotics are given no more than 72 hours perioperatively. We compared the time periods before and after implementation of antibiotic protocol in an institution review board-approved, retrospective review of neonates with congenital surgical conditions who underwent surgical correction within 30 days after birth. Surgical site infection at 30 days was the primary outcome, and development of hospital-acquired infections or multidrug-resistant organism were secondary outcomes. One hundred forty-eight infants underwent surgical procedures pre-protocol, and 127 underwent procedures post-protocol implementation. Surgical site infection rates were similar pre- and post-protocol, 14% and 9% respectively, (P = .21.) The incidence of hospital-acquired infections (13.7% vs 8.7%, P = .205) and multidrug-resistant organism (4.7% vs 1.6%, P = .143) was similar between the 2 periods. Elimination of empiric postnatal antibiotics did not statistically change rates of surgical site infection, hospital-acquired infections, or multidrug-resistant organisms. Limiting the duration of perioperative antibiotic prophylaxis to no more than 72 hours after surgery did not increase the rate of surgical site infection, hospital-acquired infections, or multidrug-resistant organism. Median antibiotic days were decreased with antibiotic standardization for surgical neonates. Copyright © 2017 Elsevier Inc. All rights reserved.

Abbreviated MRI Protocols for Detecting Breast Cancer in Women with Dense Breasts.

PubMed

Chen, Shuang-Qing; Huang, Min; Shen, Yu-Ying; Liu, Chen-Lu; Xu, Chuan-Xiao

2017-01-01

To evaluate the validity of two abbreviated protocols (AP) of MRI in breast cancer screening of dense breast tissue. This was a retrospective study in 356 participants with dense breast tissue and negative mammography results. The study was approved by the Nanjing Medical University Ethics Committee. Patients were imaged with a full diagnostic protocol (FDP) of MRI. Two APs (AP-1 consisting of the first post-contrast subtracted [FAST] and maximum-intensity projection [MIP] images, and AP-2 consisting of AP-1 combined with diffusion-weighted imaging [DWI]) and FDP images were analyzed separately, and the sensitivities and specificities of breast cancer detection were calculated. Of the 356 women, 67 lesions were detected in 67 women (18.8%) by standard MR protocol, and histological examination revealed 14 malignant lesions and 53 benign lesions. The average interpretation time of AP-1 and AP-2 were 37 seconds and 54 seconds, respectively, while the average interpretation time of the FDP was 3 minutes and 25 seconds. The sensitivities of the AP-1, AP-2, and FDP were 92.9, 100, and 100%, respectively, and the specificities of the three MR protocols were 86.5, 95.0, and 96.8%, respectively. There was no significant difference among the three MR protocols in the diagnosis of breast cancer ( p > 0.05). However, the specificity of AP-1 was significantly lower than that of AP-2 ( p = 0.031) and FDP ( p = 0.035), while there was no difference between AP-2 and FDP ( p > 0.05). The AP may be efficient in the breast cancer screening of dense breast tissue. FAST and MIP images combined with DWI of MRI are helpful to improve the specificity of breast cancer detection.

Protocol Development | Division of Cancer Prevention

Cancer.gov

The chemoprevention Phase I and II consortia must submit Letters of Intent for review and approval prior to the submission and review of the protocol. Letter of Intent (LOI) Process The chemoprevention Phase I and II consortia must submit Letters of Intent for review and approval prior to the submission and review of the protocol. DCP will solicit Letters of Intent from

Chemotherapy-Induced Cognitive Impairment: A Novel Prospective Study of the Cognitive Effects of Platinum Taxane-Based Chemotherapy in Ovarian Cancer Patients

DTIC Science & Technology

2017-09-01

post chemotherapy testing , completing all protocol-defined tests and procedures and are now off study. Two patients are currently undergoing treatment...and will complete post treatment testing within the upcoming weeks. The first patient enrolled onto this trial was unable to complete post treatment...completed post chemotherapy testing , completing all protocol-defined tests and procedures and are now off study. Two patients are currently

Protocol for a pilot randomised controlled trial of an online intervention for post-treatment cancer survivors with persistent fatigue

PubMed Central

Corbett, Teresa; Walsh, Jane C; Groarke, AnnMarie; Moss-Morris, Rona; McGuire, Brian E

2016-01-01

Introduction Many post-treatment cancer survivors experience persistent fatigue that can disrupt attempts to resume normal everyday activities after treatment. Theoretical models that aim to explain contributory factors that initiate and sustain fatigue symptoms, or that influence the efficacy of interventions for cancer-related fatigue (CrF) require testing. Adjustment to fatigue is likely to be influenced by coping behaviours that are guided by the representations of the symptom. Objectives This paper describes the protocol for a pilot trial of a systematically and theoretically designed online intervention to enable self-management of CrF after cancer treatment. Methods and analysis This 2-armed randomised controlled pilot trial will study the feasibility and potential effectiveness of an online intervention. Participants will be allocated to either the online intervention (REFRESH (Recovery from Cancer-Related Fatigue)), or a leaflet comparator. Participants 80 post-treatment cancer survivors will be recruited for the study. Interventions An 8-week online intervention based on cognitive–behavioural therapy. Primary and secondary outcome measures The primary outcome is a change in fatigue as measured by the Piper Fatigue Scale (revised). Quality of life will be measured using the Quality of Life in Adult Survivors of Cancer Scale. Outcome measures will be collected at baseline, and at completion of intervention. Results The feasibility of trial procedures will be tested, as well as the effect of the intervention on the outcomes. Conclusions This study may lead to the development of a supportive resource to target representations and coping strategies of cancer survivors with CrF post-treatment. Setting Recruitment from general public in Ireland. Ethics and dissemination This trial was approved by the Research Ethics Committee at National University of Ireland Galway in January 2013. Trial results will be communicated in a peer-reviewed journal. Trial registration number ISRCTN55763085; Pre-results. PMID:27288384

Effect modification of FADS2 polymorphisms on the association between breastfeeding and intelligence: protocol for a collaborative meta-analysis

PubMed Central

Hartwig, Fernando Pires; Davies, Neil Martin; Horta, Bernardo Lessa; Victora, Cesar Gomes; Davey Smith, George

2016-01-01

Introduction Evidence from observational studies and randomised controlled trials suggests that breastfeeding is positively associated with IQ, possibly because breast milk is a source of long-chain polyunsaturated fatty acids. Different studies have detected gene-breastfeeding interactions involving FADS2 variants and intelligence. However, findings are inconsistent regarding the direction of such effect modification. Methods/design To clarify how FADS2 and breastfeeding interact in their association with IQ, we are conducting a consortium-based meta-analysis of independent studies. Results produced by each individual study using standardised analysis scripts and harmonised data will be used. Inclusion criteria: breastfeeding, IQ and either rs174575 or rs1535 polymorphisms available; and being of European ancestry. Exclusion criteria: twin studies; only poorly imputed genetic data available; or unavailability of proper ethics approval. Studies will be invited based on being known to have at least some of the required data, or suggested by participating studies as potentially eligible. This inclusive approach will favour achieving a larger sample size and be less prone to publication bias. Discussion Improving current understanding of FADS2-breastfeeding interaction may provide important biological insights regarding the importance of long-chain polyunsaturated fatty acids for the breastfeeding-IQ association. This meta-analysis will help to improve such knowledge by replicating earlier studies, conducting additional analysis and evaluating different sources of heterogeneity. Publishing this protocol will minimise the possibility of bias due to post hoc changes to the analysis protocol. PMID:27311901

Health diplomacy the adaptation of global health interventions to local needs in sub-Saharan Africa and Thailand: Evaluating findings from Project Accept (HPTN 043)

PubMed Central

2012-01-01

Background Study-based global health interventions, especially those that are conducted on an international or multi-site basis, frequently require site-specific adaptations in order to (1) respond to socio-cultural differences in risk determinants, (2) to make interventions more relevant to target population needs, and (3) in recognition of ‘global health diplomacy' issues. We report on the adaptations development, approval and implementation process from the Project Accept voluntary counseling and testing, community mobilization and post-test support services intervention. Methods We reviewed all relevant documentation collected during the study intervention period (e.g. monthly progress reports; bi-annual steering committee presentations) and conducted a series of semi-structured interviews with project directors and between 12 and 23 field staff at each study site in South Africa, Zimbabwe, Thailand and Tanzania during 2009. Respondents were asked to describe (1) the adaptations development and approval process and (2) the most successful site-specific adaptations from the perspective of facilitating intervention implementation. Results Across sites, proposed adaptations were identified by field staff and submitted to project directors for review on a formally planned basis. The cross-site intervention sub-committee then ensured fidelity to the study protocol before approval. Successfully-implemented adaptations included: intervention delivery adaptations (e.g. development of tailored counseling messages for immigrant labour groups in South Africa) political, environmental and infrastructural adaptations (e.g. use of local community centers as VCT venues in Zimbabwe); religious adaptations (e.g. dividing clients by gender in Muslim areas of Tanzania); economic adaptations (e.g. co-provision of income generating skills classes in Zimbabwe); epidemiological adaptations (e.g. provision of ‘youth-friendly’ services in South Africa, Zimbabwe and Tanzania), and social adaptations (e.g. modification of terminology to local dialects in Thailand: and adjustment of service delivery schedules to suit seasonal and daily work schedules across sites). Conclusions Adaptation selection, development and approval during multi-site global health research studies should be a planned process that maintains fidelity to the study protocol. The successful implementation of appropriate site-specific adaptations may have important implications for intervention implementation, from both a service uptake and a global health diplomacy perspective. PMID:22716131

Association between post-game recovery protocols, physical and perceived recovery, and performance in elite Australian Football League players.

PubMed

Bahnert, Andrew; Norton, Kevin; Lock, Phillip

2013-03-01

To determine the associations between post-game recovery protocols and physical and perceptual recovery, and game performance in Australian Football League players. A longitudinal quasi-experimental study design was used across a season. A full squad of 44 footballers was monitored weekly across a 23-game season. Players were required to choose from a number of recovery modalities available immediately post-game. These included floor stretching, pool stretching, bike active recovery, pool active recovery, cold-water immersion, contrast therapy and use of a compression garment. Perceptual measures of recovery were recorded throughout the week and a test of physical performance was conducted two days post-game. Game performance ratings were also recorded. The associations between the post-game recovery protocols chosen and players' perceived recovery, and physical and game performances were determined by the association rule data-mining strategy. Statistically significant associations were found between a number of post-game recovery protocols and perceptual recovery. In general, players who chose cold-water immersion, floor stretching, no active recovery (neither bike or pool) and the use of a compression garment post-game, had an increased probability of reporting greater perceptual recovery across the following week, relative to all other permutations of recovery protocols chosen. There were no associations found between post-game recovery protocol combinations and physical recovery. No associations were found between the post-game recovery methods and the next game performance. Perceptual recovery among players was enhanced through the selection of specific combinations of recovery protocols post game. However, no links were found between recovery protocols and physical or game performance measures. Copyright © 2012 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Does bone debris in anterior cruciate ligament reconstruction really matter? A cohort study of a protocol for bone debris debridement

PubMed Central

Imam, Mohamed A.; Abdelkafy, Ashraf; Dinah, Feroz; Adhikari, Ajeya

2015-01-01

Background: The purpose of the current study was to determine whether a systematic five-step protocol for debridement and evacuation of bone debris during anterior cruciate ligament reconstruction (ACLR) reduces the presence of such debris on post-operative radiographs. Methods: A five-step protocol for removal of bone debris during arthroscopic assisted ACLR was designed. It was applied to 60 patients undergoing ACLR (Group 1), and high-quality digital radiographs were taken post-operatively in each case to assess for the presence of intra-articular bone debris. A control group of 60 consecutive patients in whom no specific bone debris protocol was applied (Group 2) and their post-operative radiographs were also checked for the presence of intra-articular bone debris. Results: In Group 1, only 15% of post-operative radiographs showed residual bone debris, compared to 69% in Group 2 (p < 0.001). Conclusion: A five-step systematic protocol for bone debris removal during arthroscopic assisted ACLR resulted in a significant decrease in residual bone debris seen on high-quality post-operative radiographs. PMID:27163060

Clinical outcomes and mortality before and after implementation of a pediatric sepsis protocol in a limited resource setting: A retrospective cohort study in Bangladesh

PubMed Central

Axelrod, David M.; Chisti, Mohammod J.; Kache, Saraswati

2017-01-01

Background Pediatric sepsis has a high mortality rate in limited resource settings. Sepsis protocols have been shown to be a cost-effective strategy to improve morbidity and mortality in a variety of populations and settings. At Dhaka Hospital in Bangladesh, mortality from pediatric sepsis in high-risk children previously approached 60%, which prompted the implementation of an evidenced-based protocol in 2010. The clinical effectiveness of this protocol had not been measured. We hypothesized that implementation of a pediatric sepsis protocol improved clinical outcomes, including reducing mortality and length of hospital stay. Materials and methods This was a retrospective cohort study of children 1–59 months old with a diagnosis of sepsis, severe sepsis or septic shock admitted to Dhaka Hospital from 10/25/2009-10/25/2011. The primary outcome was inpatient mortality pre- and post-protocol implementation. Secondary outcomes included fluid overload, heart failure, respiratory insufficiency, length of hospital stay, and protocol compliance, as measured by antibiotic and fluid bolus administration within 60 minutes of hospital presentation. Results 404 patients were identified by a key-word search of the electronic medical record; 328 patients with a primary diagnosis of sepsis, severe sepsis, or septic shock were included (143 pre- and185 post-protocol) in the analysis. Pre- and post-protocol mortality were similar and not statistically significant (32.17% vs. 34.59%, p = 0.72). The adjusted odds ratio (AOR) for post-protocol mortality was 1.55 (95% CI, 0.88–2.71). The odds for developing fluid overload were significantly higher post-protocol (AOR 3.45, 95% CI, 2.04–5.85), as were the odds of developing heart failure (AOR 4.52, 95% CI, 1.43–14.29) and having a longer median length of stay (AOR 1.81, 95% CI 1.10–2.96). There was no statistically significant difference in respiratory insufficiency (pre- 65.7% vs. post- 70.3%, p = 0.4) or antibiotic administration between the cohorts (pre- 16.08% vs. post- 12.43%, p = 0.42). Conclusions Implementation of a pediatric sepsis protocol did not improve all-cause mortality or length of stay and may have been associated with increased fluid overload and heart failure during the study period in a large, non-governmental hospital in Bangladesh. Similar rates of early antibiotic administration may indicate poor protocol compliance. Though evidenced-based protocols are a potential cost-effective strategy to improve outcomes, future studies should focus on optimal implementation of context-relevant sepsis protocols in limited resource settings. PMID:28753618

Effects of whole body cryotherapy and cold water immersion on knee skin temperature.

PubMed

Costello, J T; Donnelly, A E; Karki, A; Selfe, J

2014-01-01

This study sought to (a) compare and contrast the effect of 2 commonly used cryotherapy treatments, 4 min of -110 °C whole body cryotherapy and 8 °C cold water immersion, on knee skin temperature and (b) establish whether either protocol was capable of achieving a skin temperature (<13 °C) believed to be required for analgesic purposes. After ethics committee approval and written informed consent was obtained, 10 healthy males (26.5±4.9 yr, 183.5±6.0 cm, 90.7±19.9 kg, 26.8±5.0 kg/m2, 23.0±9.3% body fat; mean±SD) participated in this randomised controlled crossover study. Skin temperature around the patellar region was assessed in both knees via non-contact, infrared thermal imaging and recorded pre-, immediately post-treatment and every 10 min thereafter for 60 min. Compared to baseline, average, minimum and maximum skin temperatures were significantly reduced (p<0.001) immediately post-treatment and at 10, 20, 30, 40, 50 and 60 min after both cooling modalities. Average and minimum skin temperatures were lower (p<0.05) immediately after whole body cryotherapy (19.0±0.9 °C) compared to cold water immersion (20.5±0.6 °C). However, from 10 to 60 min post, the average, minimum and maximum skin temperatures were lower (p<0.05) following the cold water treatment. Finally, neither protocol achieved a skin temperature believed to be required to elicit an analgesic effect. © Georg Thieme Verlag KG Stuttgart · New York.

Improving post-stroke dysphagia outcomes through a standardized and multidisciplinary protocol: an exploratory cohort study.

PubMed

Gandolfi, Marialuisa; Smania, Nicola; Bisoffi, Giulia; Squaquara, Teresa; Zuccher, Paola; Mazzucco, Sara

2014-12-01

Stroke is a major cause of dysphagia. Few studies to date have reported on standardized multidisciplinary protocolized approaches to the management of post-stroke dysphagia. The aim of this retrospective cohort study was to evaluate the impact of a standardized multidisciplinary protocol on clinical outcomes in patients with post-stroke dysphagia. We performed retrospective chart reviews of patients with post-stroke dysphagia admitted to the neurological ward of Verona University Hospital from 2004 to 2008. Outcomes after usual treatment for dysphagia (T- group) were compared versus outcomes after treatment under a standardized diagnostic and rehabilitative multidisciplinary protocol (T+ group). Outcome measures were death, pneumonia on X-ray, need for respiratory support, and proportion of patients on tube feeding at discharge. Of the 378 patients admitted with stroke, 84 had dysphagia and were enrolled in the study. A significantly lower risk of in-hospital death (odds ratio [OR] 0.20 [0.53-0.78]), pneumonia (OR 0.33 [0.10-1.03]), need for respiratory support (OR 0.48 [0.14-1.66]), and tube feeding at discharge (OR 0.30 [0.09-0.91]) was recorded for the T+ group (N = 39) as compared to the T- group (N = 45). The adjusted OR showed no difference between the two groups for in-hospital death and tube feeding at discharge. Use of a standardized multidisciplinary protocolized approach to the management of post-stroke dysphagia may significantly reduce rates of aspiration pneumonia, in-hospital mortality, and tube feeding in dysphagic stroke survivors. Consistent with the study's exploratory purposes, our findings suggest that the multidisciplinary protocol applied in this study offers an effective model of management of post-stroke dysphagia.

21 CFR 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.

Code of Federal Regulations, 2011 CFR

2011-04-01

... defined in § 20.81. (2) Any protocol for a test or study unless the protocol is shown to constitute trade... available for public disclosure. (3) Quantitative or semiquantitative formulas. [51 FR 26364, July 22, 1986...

Obesity/Overweight in Persons With Early and Chronic SCI: A Randomized, Multicenter, Controlled Lifestyle Intervention

DTIC Science & Technology

2014-10-01

A.J. Mendez, S.L. Groah, J. Kressler. Fasting plasma glucose values may significantly underestimate prevalence of dysfunctional glycemic regulation in...taken corrective actions without undertaking additional protocol changes. There have been no screening issues since protocol amendments were approved...extending approval for the project through September 9, 2015. Enclosed is the dated/stamped Informed Consent Form, approved for one additional year until

FDA approved drugs complexed to their targets: evaluating pose prediction accuracy of docking protocols.

PubMed

Bohari, Mohammed H; Sastry, G Narahari

2012-09-01

Efficient drug discovery programs can be designed by utilizing existing pools of knowledge from the already approved drugs. This can be achieved in one way by repositioning of drugs approved for some indications to newer indications. Complex of drug to its target gives fundamental insight into molecular recognition and a clear understanding of putative binding site. Five popular docking protocols, Glide, Gold, FlexX, Cdocker and LigandFit have been evaluated on a dataset of 199 FDA approved drug-target complexes for their accuracy in predicting the experimental pose. Performance for all the protocols is assessed at default settings, with root mean square deviation (RMSD) between the experimental ligand pose and the docked pose of less than 2.0 Å as the success criteria in predicting the pose. Glide (38.7 %) is found to be the most accurate in top ranked pose and Cdocker (58.8 %) in top RMSD pose. Ligand flexibility is a major bottleneck in failure of docking protocols to correctly predict the pose. Resolution of the crystal structure shows an inverse relationship with the performance of docking protocol. All the protocols perform optimally when a balanced type of hydrophilic and hydrophobic interaction or dominant hydrophilic interaction exists. Overall in 16 different target classes, hydrophobic interactions dominate in the binding site and maximum success is achieved for all the docking protocols in nuclear hormone receptor class while performance for the rest of the classes varied based on individual protocol.

Establishing the first institutional animal care and use committee in Egypt.

PubMed

Fahmy, Sohair R; Gaafar, Khadiga

2016-04-09

Although animal research ethics committees (AREC) are well established in Western countries, this field is weakly developed and its concept is poorly understood in the Middle East and North Africa region. Our main objective was to introduce the concept and requirements of ethical approaches in dealing with experimental animal in research and teaching in Egypt. Due to its very recent inception, Cairo University, Faculty of Science IACUC decided to operate in accordance with Guide for the Care and Use of Laboratory Animals 8th Edition 2011 (the Guide) since Egypt has not yet compiled its own guide. Fifty protocols were reviewed in 2013-2014. Only ten protocols were reviewed in 2013, but in 2014, forty protocols were reviewed. In 2013 all protocols were approved and in 2014, number of approvals were 35, the number of deferrals were 4, and one refused protocol. Master's theses (MSc) research protocols constituted the majority of the total reviewed protocols. This is attributed to the decision of the Board of the Faculty of Science, Cairo University in September, 2013 that the approval of the IACUC is mandatory before conducting any research involving animals or theses registration. The first IACUC was established in the Cairo University, Faculty of Science, since 2012. The challenges encountered by the committee were diverse, such as the absence of laws that control the use of animal models in scientific research, lack of guidelines (protocols for experimental animals in research) and, mandatory ethical approval for any experimental animal research.

Implementation of an Intensive Care Unit-Specific Alcohol Withdrawal Syndrome Management Protocol Reduces the Need for Mechanical Ventilation.

PubMed

Heavner, Jason J; Akgün, Kathleen M; Heavner, Mojdeh S; Eng, Claire C; Drew, Matthew; Jackson, Peter; Pritchard, David; Honiden, Shyoko

2018-05-25

Alcohol use disorders are prevalent and put patients at risk for developing alcohol withdrawal syndrome (AWS). Treatment of AWS with a symptom-triggered protocol standardizes management and may avoid AWS-related complications. The objective of this study was to evaluate whether implementation of an intensive care unit (ICU)-specific, symptom-triggered protocol for management of AWS was associated with improved clinical outcomes and, in particular, would reduce the risk of patients with AWS requiring mechanical ventilation. Retrospective pre-post-protocol implementation study. Thirty-six-bed, closed medical ICU (MICU) at a large, tertiary care, teaching hospital in an urban setting. A total of 233 adults admitted to the MICU with any diagnosis of alcohol use disorders based on International Classification of Diseases, Ninth Revision codes and who received at least one dose of any benzodiazepine; of these patients, 139 were in the pre-protocol era (August 2009-January 2010 and August 2010-January 2011), and 94 were in the post-protocol era (August 2012-January 2013), after implementation of the Yale Alcohol Withdrawal Protocol (YAWP) in April 2012. The YAWP pairs a modified Minnesota Detoxification Scale with an order set that includes benzodiazepine dosing regimens and suggests adjuvant therapies. AWS was the primary reason for ICU admission (107/233 patients [45.9%]) and did not significantly vary between eras (P=0.2). Of the 233 patients included, 81.1% were male and 67.0% were white, which did not significantly differ by study era. Severity of illness at MICU admission did not significantly differ between patients in the pre-protocol and post-protocol eras (median [interquartile range] Acute Physiology and Chronic Health Evaluation [APACHE] II scores of 12 [9-17] and 12.5 [7-16], respectively, p=0.4). Median lorazepam-equivalent dose per MICU day, duration of benzodiazepine infusion, and use of adjuvant therapy were not significantly different between eras. MICU intubation was less common in the post-protocol era (36/139 patients [25.9%] pre-protocol vs 8/94 patients [8.5%] post-protocol, p=0.0009). ICU-related pneumonia was also decreased in the post-protocol era (30/139 patients [21.6%] pre-protocol vs 10/94 patients [10.6%] post-protocol, p=0.03). After adjusting for demographics, adjuvant therapies, and Acute Physiology and Chronic Health Evaluation II scores, protocol implementation was associated with a decreased odds of MICU intubation (odds ratio 0.13; 95% confidence interval 0.04-0.39). Implementation of YAWP was associated with a decreased risk of MICU intubation in patients at risk for AWS. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

30 CFR 14.10 - Post-approval product audit.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Post-approval product audit. 14.10 Section 14... General Provisions § 14.10 Post-approval product audit. (a) Approved conveyor belts will be subject to... applicant and other persons agreed upon by MSHA and the applicant may be present during audit tests and...

30 CFR 14.10 - Post-approval product audit.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Post-approval product audit. 14.10 Section 14... General Provisions § 14.10 Post-approval product audit. (a) Approved conveyor belts will be subject to... applicant and other persons agreed upon by MSHA and the applicant may be present during audit tests and...

30 CFR 14.10 - Post-approval product audit.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Post-approval product audit. 14.10 Section 14... General Provisions § 14.10 Post-approval product audit. (a) Approved conveyor belts will be subject to... applicant and other persons agreed upon by MSHA and the applicant may be present during audit tests and...

30 CFR 250.282 - Do I have to conduct post-approval monitoring?

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 2 2011-07-01 2011-07-01 false Do I have to conduct post-approval monitoring... ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL... conduct post-approval monitoring? After approving your EP, DPP, or DOCD, the Regional Supervisor may...

30 CFR 71.301 - Respirable dust control plan; approval by District Manager and posting.

Code of Federal Regulations, 2010 CFR

2010-07-01

... District Manager and posting. 71.301 Section 71.301 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... plan; approval by District Manager and posting. (a) The District Manager will approve respirable dust control plans on a mine-by-mine basis. When approving respirable dust control plans, the District Manager...

[Effect of a multidisciplinar protocol on the clinical results obtained after bariatric surgery].

PubMed

Cánovas Gaillemin, B; Sastre Martos, J; Moreno Segura, G; Llamazares Iglesias, O; Familiar Casado, C; Abad de Castro, S; López Pardo, R; Sánchez-Cabezudo Muñoz, M A

2011-01-01

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. To assess the usefulness of the implementation of a management protocol in obesity surgery based on the Spanish Consensus Document of the SEEDO. Retrospective comparative study of the outcomes in patients previously operated (51 patients) and after the implementation of the protocol (66 patients). The following data were gathered: anthropometry, pre-and post-surgery comorbidities, post-surgical nutritional and surgical complications, validated Quality of Life questionnaire, and dietary habits. Withdrawals (l7.6%) and alcoholism (5.8%) were higher in patients pre- versus post-implementation of the protocol (4.5% vs. 3%, respectively), the differences being statistically significant. The mortality rate was 2% in the pre-protocol group and 0% in the postprotocol group. The dietary habits were better in the post-protocol group, the pre-protocol group presenting a higher percentage of feeding-behavior disorders (5.1%) although not reaching a statistical significance. The improvement in quality of life was higher in the post-protocol group for all items, but only reaching statistical significance in sexual activity (p = 0.004). In the pre-protocol group, 70.5% of the patients had more than one nutritional complication vs. 32.8% in the post-protocol group (p < 0.05). There were no differences regarding the percentage of weight in excess lost at two years (> 50% in 81.3% in the pre-protocol group vs. 74.8% in the pos-protocol group) or the comorbidities. Bariatric surgery achieves excellent outcomes in weight loss, comorbidities, and quality of life, but presents nutritional, surgical, and psychiatric complications that require a protocol-based and multidisciplinary approach. Our protocol improves the outcomes regarding the withdrawal rates, feeding-behavior disorders, dietary habits, nutritional complications, and quality of life.

Earlier defibrotide initiation post-diagnosis of veno-occlusive disease/sinusoidal obstruction syndrome improves Day +100 survival following haematopoietic stem cell transplantation.

PubMed

Richardson, Paul G; Smith, Angela R; Triplett, Brandon M; Kernan, Nancy A; Grupp, Stephan A; Antin, Joseph H; Lehmann, Leslie; Miloslavsky, Maja; Hume, Robin; Hannah, Alison L; Nejadnik, Bijan; Soiffer, Robert J

2017-07-01

Hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) is a progressive, potentially fatal complication of conditioning for haematopoietic stem cell transplant (HSCT). The VOD/SOS pathophysiological cascade involves endothelial-cell activation and damage, and a prothrombotic-hypofibrinolytic state. Severe VOD/SOS (typically characterized by multi-organ dysfunction) may be associated with >80% mortality. Defibrotide is approved for treating severe hepatic VOD/SOS post-HSCT in the European Union, and for hepatic VOD/SOS with renal or pulmonary dysfunction post-HSCT in the United States. Previously, defibrotide (25 mg/kg/day in 4 divided doses for a recommended ≥21 days) was available through an expanded-access treatment protocol for patients with VOD/SOS. Data from this study were examined post-hoc to determine if the timing of defibrotide initiation post-VOD/SOS diagnosis affected Day +100 survival post-HSCT. Among 573 patients, defibrotide was started on the day of VOD/SOS diagnosis in approximately 30%, and within 7 days in >90%. The relationship between Day +100 survival and treatment initiation before/after specific days post-diagnosis showed superior survival when treatment was initiated closer to VOD/SOS diagnosis with a statistically significant trend over time for better outcomes with earlier treatment initiation (P < 0·001). These results suggest that initiation of defibrotide should not be delayed after diagnosis of VOD/SOS. © 2017 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd.

Research ethics review at University Eduardo Mondlane (UEM)/Maputo Central Hospital, Mozambique (2013-2016): a descriptive analysis of the start-up of a new research ethics committee (REC).

PubMed

Sacarlal, Jahit; Muchanga, Vasco; Mabutana, Carlos; Mabui, Matilde; Mariamo, Arlete; Cuamba, Assa Júlio; Fumo, Leida Artur; Silveira, Jacinta; Heitman, Elizabeth; Moon, Troy D

2018-05-23

Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique (CNBS) encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine (FM) of University Eduardo Mondlane (UEM) and the Maputo Central Hospital (MCH) established a joint Institutional Committee on Bioethics for Health (CIBS FM & MCH). This study examines the experience of the first 4 years of the CIBS FM & MCH. This study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee's respective reviews and actions. A total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, faculty, and researchers from UEM, mainly related to Master's degree research (42%). Descriptive cross-sectional studies were the most frequently reviewed research (61%). The majority were prospective (71%) and used quantitative methodologies (51%). The Departments of Internal Medicine at MCH and Community Health at the FM submitted the most protocols from their respective institutions, with 38 and 53% respectively. The CIBS's average time to final approval for all protocols was 56 days, rising to 161 for the 40 protocols that required subsequent national-level review by the CNBS. Our results show that over its first 4 years, the CIBS FM & MCH has been successful in managing a constant demand for protocol review and that several broad quality improvement initiatives, such as investigator mentoring and an electronic protocol submission platform have improved efficiency in the review process and the overall quality of the protocols submitted. Beyond Maputo, long-term investments in training and ethical capacity building for CIBS across the country continue to be needed, as Mozambique develops greater capacity for research and makes progress toward improving the health of all its citizens.

42 CFR 84.310 - Post-approval testing.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Respirators § 84.310 Post-approval testing. (a) NIOSH will periodically test the capacity and performance of units of approved CCERs. (b) NIOSH may test units that are new and/or units that have been deployed in... 42 Public Health 1 2014-10-01 2014-10-01 false Post-approval testing. 84.310 Section 84.310 Public...

42 CFR 84.310 - Post-approval testing.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Respirators § 84.310 Post-approval testing. (a) NIOSH will periodically test the capacity and performance of units of approved CCERs. (b) NIOSH may test units that are new and/or units that have been deployed in... 42 Public Health 1 2013-10-01 2013-10-01 false Post-approval testing. 84.310 Section 84.310 Public...

42 CFR 84.310 - Post-approval testing.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Respirators § 84.310 Post-approval testing. (a) NIOSH will periodically test the capacity and performance of units of approved CCERs. (b) NIOSH may test units that are new and/or units that have been deployed in... 42 Public Health 1 2012-10-01 2012-10-01 false Post-approval testing. 84.310 Section 84.310 Public...

Post-Closure Inspection Report for the Tonopah Test Range, Nevada. For Calendar Year 2015, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Matthews, Patrick; Petrello, Jaclyn

This report provides the results of the annual post-closure inspections conducted at the closed corrective action units (CAUs) located on the Tonopah Test Range (TTR), Nevada. This report covers calendar year 2015 and includes inspection and repair activities completed at the following CAUs; CAU 400: Bomblet Pit and Five Points Landfill (TTR); CAU 407: Roller Coaster RadSafe Area (TTR); CAU 424: Area 3 Landfill Complexes (TTR); CAU 453: Area 9 UXO Landfill (TTR); and CAU 487: Thunderwell Site (TTR) Inspections were conducted according to the post-closure plans in the approved closure reports and subsequent correspondence with the Nevada Division ofmore » Environmental Protection. The post-closure inspection plans and subsequent correspondence modifying the requirements for each CAU are included in Appendix B. The inspection checklists are included in Appendix C. Field notes are included in Appendix D. The annual post-closure inspections were conducted on May 12, 2015. Maintenance was required at CAU 453. Cracking along the north trench was repaired. One monument is missing at CAU 424; it will be replaced in 2016. Postings at CAUs 407, 424, 453, and 487 contain contact information for TTR Security. It was noted that protocols may not be in place to ensure that the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office (NNSA/NFO) is notified if access is needed at these sites. NNSA/NFO is working with the U.S. Air Force and Sandia to determine whether more appropriate contact information or new protocols are warranted for each CAU. Based on these inspections, there has not been a significant change in vegetation, and vegetation monitoring was not recommended at CAU 400 or CAU 407 in 2015.« less

Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

PubMed

Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

2017-06-01

An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post-marketing boxed warning. Although drugs approved with a boxed warning or priority review are more likely to experience serious post-marketing safety events, other information provided during the FDA drug review that is easy to quantify is generally not associated with post-marketing safety events. It appears that these post-marketing events are not discernible during a pre-marketing review and therefore might not be avoidable using current review data.

Xrootd in dCache - design and experiences

NASA Astrophysics Data System (ADS)

Behrmann, Gerd; Ozerov, Dmitry; Zangerl, Thomas

2011-12-01

dCache is a well established distributed storage solution used in both high energy physics computing and other disciplines. An overview of the implementation of the xrootd data access protocol within dCache is presented. The performance of various access mechanisms is studied and compared and it is concluded that our implementation is as perfomant as other protocols. This makes dCache a compelling alternative to the Scalla software suite implementation of xrootd, with added value from broad protocol support, including the IETF approved NFS 4.1 protocol.

Demonstrating Patterns in the Views Of Stakeholders Regarding Ethically-Salient Issues in Clinical Research: A Novel Use of Graphical Models in Empirical Ethics Inquiry.

PubMed

Kim, Jane Paik; Roberts, Laura Weiss

Empirical ethics inquiry works from the notion that stakeholder perspectives are necessary for gauging the ethical acceptability of human studies and assuring that research aligns with societal expectations. Although common, studies involving different populations often entail comparisons of trends that problematize the interpretation of results. Using graphical model selection - a technique aimed at transcending limitations of conventional methods - this report presents data on the ethics of clinical research with two objectives: (1) to display the patterns of views held by ill and healthy individuals in clinical research as a test of the study's original hypothesis and (2) to introduce graphical model selection as a key analytic tool for ethics research. In this IRB-approved, NIH-funded project, data were collected from 60 mentally ill and 43 physically ill clinical research protocol volunteers, 47 healthy protocol-consented participants, and 29 healthy individuals without research protocol experience. Respondents were queried on the ethical acceptability of research involving people with mental and physical illness (i.e., cancer, HIV, depression, schizophrenia, and post-traumatic stress disorder) and non-illness related sources of vulnerability (e.g., age, class, gender, ethnicity). Using a statistical algorithm, we selected graphical models to display interrelationships among responses to questions. Both mentally and physically ill protocol volunteers revealed a high degree of connectivity among ethically-salient perspectives. Healthy participants, irrespective of research protocol experience, revealed patterns of views that were not highly connected. Between ill and healthy protocol participants, the pattern of views is vastly different. Experience with illness was tied to dense connectivity, whereas healthy individuals expressed views with sparse connections. In offering a nuanced perspective on the interrelation of ethically relevant responses, graphical model selection has the potential to bring new insights to the field of ethics.

Staff Scientist | Center for Cancer Research

Cancer.gov

The scientist will be tasked with independent research projects that support and/or further the scope of our laboratory goals as determined by the Principal Investigator. The scientist will be responsible for overseeing daily operations and coordination of projects in close conjunction with all laboratory personnel. The scientist will participate in teaching laboratory methods to first-time post-docs, research fellows, and students. The scientist will work closely with a full-time research biologist, both in collaboration of research projects and in the lab-critical administrative tasks of IRB-approval, animal protocols, budget, etc. Our laboratory has two post-doctoral researchers at any given time. This is a great opportunity for candidates who are interested in cancer biology and want to grow their research career by working in our program with outstanding support of other established laboratories and core facilities in the National Cancer Institute.

Post-approval safety issues with innovative drugs: a European cohort study.

PubMed

Mol, Peter G M; Arnardottir, Arna H; Motola, Domenico; Vrijlandt, Patrick J; Duijnhoven, Ruben G; Haaijer-Ruskamp, Flora M; de Graeff, Pieter A; Denig, Petra; Straus, Sabine M J M

2013-11-01

At time of approval, knowledge of the full benefit risk of any drug is limited, in particular with regards to safety. Post-approval surveillance of potential drug safety concerns is recognized as an important task of regulatory agencies. For innovative, often first-in-class drugs, safety knowledge at time of approval is often even less extensive and these may require tighter scrutiny post approval. We evaluated whether more post-approval serious safety issues were identified for drugs with a higher level of innovation. A cohort study was performed that included all new active substances approved under the European Centralized Procedure and for which serious safety issues were identified post-approval from 1 January 1999 to 1 January 2012. Serious safety issues were defined as issues requiring a Direct Healthcare Professional Communication to alert individual healthcare professionals of a new serious safety issue, or a safety-related drug withdrawal. Data were retrieved from publicly available websites of the Dutch Medicines Evaluation Board and the European Medicines Agency. The level of innovation was scored using a validated algorithm, grading drugs as important (A), moderate (B) or modest (C) innovations or as pharmacological or technological (pharm/tech) innovations. The data were analyzed using appropriate descriptive statistics and Kaplan-Meier analysis, with a Mantel-Cox log-rank test, and Cox-regression models correcting for follow-up duration, to identify a possible trend in serious safety issues with an increasing level of innovation. In Europe, 279 new drugs were approved between 1999 and 2011. Fifty-nine (21 %) were graded as important, 63 (23 %) moderate, or 34 (12 %) modest innovations and 123 (44 %) as non-innovative (pharm/tech), while 15 (25 %), 13 (21 %), 8 (24 %) and 17 (14 %) had post-approval safety issues, respectively (p = 0.06, linear-by-linear test). Five drugs were withdrawn from the market. The Kaplan-Meier-derived probability for having a first serious safety issue was statistically significant, log-rank (Mantel-Cox) p = 0.036. In the final adjusted Cox proportional hazard model there was no statistically significant difference in occurrence of a first serious safety issue for important, moderate and modest innovations versus non-innovative drugs; hazard ratios 1.76 (95 % CI 0.82-3.77), 1.61 (95 % CI 0.76-3.41)], and 1.25 (95 % CI 0.51-3.06), respectively. A higher level of innovation was not clearly related to an increased risk of serious safety issues identified after approval.

Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study.

PubMed

Zeitoun, Jean-David; Baron, Gabriel; Vivot, Alexandre; Atal, Ignacio; Downing, Nicholas S; Ross, Joseph S; Ravaud, Philippe

2018-01-15

Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.gov through September 2014 for novel anticancer agents approved by both the US Food and Drug Administration and the European Medicines Agency between 2005 and 2010. All relevant post-marketing trials were classified according to indication, primary outcome, starting date, sponsors, and planned enrollment. Supplemental indications were retrieved from regulatory documents and publication rate was assessed by two different methods. Ten novel anticancer agents were eligible: five were indicated for hematologic malignancies and the remaining five for solid cancers (three for kidney cancer). We identified 2,345 post-marketing trials; 1,362 (58.1%) targeted an indication other than the originally approved one. We observed extreme variations among drugs in both number of post-marketing trials (range 8-530) and overall population to be enrolled per trial (1-8,381). Post-marketing trials assessed almost all types of cancers, the three most frequently studied cancers being leukemia, kidney cancer and myeloma. In all, 6.6% of post-marketing trials had a clinical endpoint as a primary outcome, and 35.9% and 54.1% had a safety or surrogate endpoint, respectively, as a primary outcome. Nine drugs obtained approval for supplemental indications. The publication rate at 10 years was 12.3 to 26.1% depending on the analysis method. In conclusion, we found that post-marketing research in oncology is highly heterogeneous and the publication rate of launched trials is low. © 2017 UICC.

Russia’s Energy Policies and Ukraine’s NATO Candidacy

DTIC Science & Technology

2008-06-01

Government of Ukraine, “WTO protocol approved una voce nearly,” Web Portal of Ukrainian Government, April 10, 2008, http://www.kmu.gov.ua/control...with Eni into Libya fuels EU security fears.” Financial Times, April 3, 2008, 25. Government of Ukraine. “WTO protocol approved una voce nearly

Perceived effects of the economic recession on population mental health, well-being and provision of care by primary care users and professionals: a qualitative study protocol in Portugal

PubMed Central

Frasquilho, Diana; Cardoso, Graça; Pereira, Nádia; Silva, Manuela; Caldas-de-Almeida, José Miguel; Ferrão, João

2017-01-01

Introduction Economic recession periods can pose accentuated risks to population’s mental health and well-being as well as additional threats to health systems. Users and health professionals are key stakeholders in care delivery; however, little attention has been given to their experiences of the crisis. This paper presents a qualitative study protocol to assess users’ and health professionals’ perceptions about the effects of the post-2008 economic recession on mental health and care delivery in the Lisbon Metropolitan Area, Portugal. Methods and analysis The methodology to assess perceived effects of the economic recession by primary care users and professionals on population mental health, well-being and provision of care is presented. Focus groups with users and semistructured interviews with health professionals will be carried out in three primary healthcare units in Lisbon areas especially affected by the crisis. Thematic analysis of full-transcribed interviews will be conducted using an iterative and reflexive approach. Ethics and dissemination The study protocol was approved by the Ethics Committee of NOVA Medical School, NOVA University of Lisbon. The findings will be useful for other researchers and policy-makers to develop and implement the assessment of prevailing experiences of users and health professionals on the effects of the economic recession on mental health and quality of care in primary health context, promoting their involvement and contribution to services responsiveness. PMID:28871022

Guidelines for the collection of continuous stream water-temperature data in Alaska

USGS Publications Warehouse

Toohey, Ryan C.; Neal, Edward G.; Solin, Gary L.

2014-01-01

Objectives of stream monitoring programs differ considerably among many of the academic, Federal, state, tribal, and non-profit organizations in the state of Alaska. Broad inclusion of stream-temperature monitoring can provide an opportunity for collaboration in the development of a statewide stream-temperature database. Statewide and regional coordination could reduce overall monitoring cost, while providing better analyses at multiple spatial and temporal scales to improve resource decision-making. Increased adoption of standardized protocols and data-quality standards may allow for validation of historical modeling efforts with better projection calibration. For records of stream water temperature to be generally consistent, unbiased, and reproducible, data must be collected and analyzed according to documented protocols. Collection of water-temperature data requires definition of data-quality objectives, good site selection, proper selection of instrumentation, proper installation of sensors, periodic site visits to maintain sensors and download data, pre- and post-deployment verification against an NIST-certified thermometer, potential data corrections, and proper documentation, review, and approval. A study created to develop a quality-assurance project plan, data-quality objectives, and a database management plan that includes procedures for data archiving and dissemination could provide a means to standardize a statewide stream-temperature database in Alaska. Protocols can be modified depending on desired accuracy or specific needs of data collected. This document is intended to guide users in collecting time series water-temperature data in Alaskan streams and draws extensively on the broader protocols already published by the U.S. Geological Survey.

CINRG: Infrastructure for Clinical Trials in Duchenne Dystrophy

DTIC Science & Technology

2012-09-01

Cardiac Outcome Measures in Children with Muscular Dystrophy o Cardiac MRI Protocol: PITT0110 - Cardiac Magnetic Resonance: A Parallel Protocol...permitted during the study. Study drug. The study drug was PTX (Trental; Sanofi- Aventis U.S. LLC, Bridgewater, NJ) tablets , an FDA-approved pharmaceutical...that is available for oral administration as 400-mg oblong tablets . Both the study drug PTX and placebo were overencapsulated by Capsugel (Pfizer Inc

Biometrics IRB best practices and data protection

NASA Astrophysics Data System (ADS)

Boehnen, Christopher; Bolme, David; Flynn, Patrick

2015-05-01

The collection of data from human subjects for biometrics research in the United States requires the development of a data collection protocol that is reviewed by a Human Subjects Institutional Review Board (IRB). The IRB reviews the protocol for risks and approves it if it meets the criteria for approval specified in the relevant Federal regulations (45 CFR 46). Many other countries operate similar mechanisms for the protection of human subjects. IRBs review protocols for safety, confidentiality, and for minimization of risk associated with identity disclosure. Since biometric measurements are potentially identifying, IRB scrutiny of biometrics data collection protocols can be expected to be thorough. This paper discusses the intricacies of IRB best practices within the worldwide biometrics community. This is important because research decisions involving human subjects are made at a local level and do not set a precedent for decisions made by another IRB board. In many cases, what one board approves is not approved by another board, resulting in significant inconsistencies that prove detrimental to both researchers and human subjects. Furthermore, the level of biometrics expertise may be low on IRBs, which can contribute to the unevenness of reviews. This publication will suggest possible best practices for designing and seeking IRB approval for human subjects research involving biometrics measurements. The views expressed are the opinions of the authors.

Effect of two complex training protocols of back squats in blood indicators of muscular damage in military athletes

PubMed Central

Ojeda, Álvaro Huerta; Ríos, Luis Chirosa; Barrilao, Rafael Guisado; Ríos, Ignacio Chirosa; Serrano, Pablo Cáceres

2016-01-01

[Purpose] The aim of this study was to determine the variations in the blood muscular damage indicators post application of two complex training programs for back squats. [Subjects and Methods] Seven military athletes were the subjects of this study. The study had a quasi-experimental cross-over intra-subject design. Two complex training protocols were applied, and the variables to be measured were cortisol, metabolic creatine kinase, and total creatine kinase. For the statistical analysis, Student’s t-test was used. [Results] Twenty-four hours post effort, a significant decrease in cortisol level was shown for both protocols; however, the metabolic creatine kinase and total creatine kinase levels showed a significant increase. [Conclusion] Both protocols lowered the indicator of main muscular damage in the blood supply (cortisol). This proved that the work weight did not generate significant muscular damage in the 24-hour post-exercise period. PMID:27313356

Effect of two complex training protocols of back squats in blood indicators of muscular damage in military athletes.

PubMed

Ojeda, Álvaro Huerta; Ríos, Luis Chirosa; Barrilao, Rafael Guisado; Ríos, Ignacio Chirosa; Serrano, Pablo Cáceres

2016-05-01

[Purpose] The aim of this study was to determine the variations in the blood muscular damage indicators post application of two complex training programs for back squats. [Subjects and Methods] Seven military athletes were the subjects of this study. The study had a quasi-experimental cross-over intra-subject design. Two complex training protocols were applied, and the variables to be measured were cortisol, metabolic creatine kinase, and total creatine kinase. For the statistical analysis, Student's t-test was used. [Results] Twenty-four hours post effort, a significant decrease in cortisol level was shown for both protocols; however, the metabolic creatine kinase and total creatine kinase levels showed a significant increase. [Conclusion] Both protocols lowered the indicator of main muscular damage in the blood supply (cortisol). This proved that the work weight did not generate significant muscular damage in the 24-hour post-exercise period.

Carbon Offsets in California: What Role for Earth Scientists in the Policy Process? (Invited)

NASA Astrophysics Data System (ADS)

Cullenward, D.; Strong, A. L.

2013-12-01

This talk addresses the policy structure in California for developing and approving carbon offset protocols, which rely on findings from the environmental and earth sciences communities. In addition to providing an overview of the legal requirements of carbon offsets, we describe a series of case studies of how scientists can engage with policymakers. Based on those experiences, we suggest ways for the earth sciences community to become more involved in climate policy development. California's climate law, known as AB 32, requires that major sectors of the state's economy reduce their emissions to 1990 levels by 2020. As part of AB 32, the California Air Resources Board created a cap-and-trade market to ensure compliance with the statutory target. Under this system, regulated companies have to acquire tradable emissions permits (called 'compliance instruments') for the greenhouse gas emissions they release. The State allocates a certain number of allowances to regulated entities through a mixture of auctions and free transfers, with the total number equal to the overall emissions target; these allowances, along with approved offsets credits, are the compliance instruments that regulated entities are required to obtain by law. One of the key policy design issues in California's cap-and-trade market concerns the use of carbon offsets. Under AB 32, the Air Resources Board can issue offset credits to project developers who reduce emissions outside of the capped sectors (electricity, industry, and transportation)--or even outside of California--pursuant to approved offset protocols. Project developers then sell the credits to regulated companies in California. Essentially, offsets allow regulated entities in California to earn credit for emissions reductions that take place outside the scope of AB 32. Many regulated entities and economists are in favor of offsets because they view them as a source of low-cost compliance instruments. On the other hand, critics argue that some offset protocols award credits for activities that would have occurred anyway; by replacing a company's need to acquire an allowance in the carbon market, critics believe that poorly designed offset protocols increase greenhouse gas emissions. Thus, the effectiveness of the policy approach depends on the scientific integrity of the offset protocols. To date, California has approved offset protocols for emissions reductions in four applications: (1) forestry, (2) urban forestry, (3) livestock, and (4) destruction of ozone-depleting substances. In addition, the State is currently considering protocols that would address (5) methane emissions from mining and (6) greenhouse gas reductions from improved rice cultivation practices. These protocols rely heavily on findings from the environmental and earth sciences communities, especially when the protocol subject involves land use or land use change. Yet, due to budget constraints, the Air Resources Board is relying primarily on third-party protocol developers to design and propose the detailed structures under which offset credits will be issued. Despite the fact that any member of the public may participate in the governance regime that leads to protocol approvals, few scientists or scientific organizations provide input into the policy process. We use case studies from several of the California protocols to illustrate ways scientists can apply their skills to a crucial stage of climate policy development.

Multicenter cohort study on association of genotypes with prospective sports concussion: methods, lessons learned, and recommendations.

PubMed

Terrell, Thomas R; Bostick, Roberd; Barth, Jeffrey; Sloane, Richard; Cantu, Robert C; Bennett, Ellen; Galloway, Leslie; Laskowitz, Daniel; Erlanger, Dave; McKeag, Doug; Valentine, Verle; Nichols, Gregory

2017-01-01

Approximately 3.8 million sports related TBIs occur per year. Genetic variation may affect both TBI risk and post-TBI clinical outcome. Limited research has focused on genetic risk for concussion among athletes. We describe the design, methods, and baseline characteristics of this prospective cohort study designed to investigate a potential association between genetic polymorphisms of apolipoprotein E gene, APOE promoter G-219T, and Tau gene exon 6 polymorphisms (Ser53 Pro and Hist47Tyr) with: 1) the risk of prospective concussion; 2) concussion severity; and 3) postconcussion neurocognitive recovery. The prospective cohort study included a final population of 2947 college, high school, and professional athletes. Baseline data collection included a concussion/medical history questionnaire, neuropsychological (NP) testing, and genetic sampling for the genetic polymorphisms. Data collection on new concussions experienced utilized post-concussion history/mental status form, Lovell post-concussion symptom score, Standardized Assessment of Concussion (SAC) and/or the Sports Concussion Assessment Tool (SCAT)-1/SCAT-2, and post-concussion NP testing. This paper is focused on discussing the important methodological considerations, organizational challenges and lessons learned in the completion of a multi-center prospective cohort study. A total of 3740 subjects enrolled, with a total of 335 concussions experienced. Of critical importance to the success of a study of this type is to successfully recruit committed institutions with qualified local study personnel, obtain "buy-in" from study sites, and cultivate strong working relationships with study sites. The use of approved incentives may improve study site recruitment, enhance retention, and enhance compliance with study protocols. Future publications will detail the specific findings of this study. Collaborative research is very likely needed given the nature of this study population.

Ethical considerations in design of a study to evaluate a US Food and Drug Administration-approved indication: antivenom versus placebo for copperhead envenomation.

PubMed

Gerardo, Charles J; Lavonas, Eric J; McKinney, Ross E

2014-10-01

In 2000, the US Food and Drug Administration approved CroFab(®) Crotalidae Polyvalent Immune Fab, ovine (FabAV), which had received orphan drug designation, for use in patients with minimal to moderate North American crotaline envenomations including copperhead snakes. As existing evidence on the effectiveness of FabAV for this indication is limited, wide practice variation in its use exists. In order to provide more definitive clinical evidence as to the role of this treatment, a new randomized, placebo-controlled trial of FabAV specifically for copperhead bites was initiated. In light of the existing US Food and Drug Administration approval, ethical considerations of participation in this trial have been raised. We discuss the ethical principles pertinent to this randomized, placebo-controlled trial with placebo arm. We apply an accepted framework for ethical research to this trial. Due to the evidence gap in the literature, wide-ranging treatment recommendations by medical experts, and broad practice variation, clinical equipoise exists in the treatment of copperhead envenomation with FabAV. The impact of this clinical equipoise on the value and scientific validity of the trial is discussed. The trial's risk-benefit ratio is also considered. Potential risks to the patients are minimized as the protocol includes a plan for rescue therapy in the event that patients progress to severe envenomation symptoms. Overall, risks are further minimized by the inclusion of an interim analysis with stopping rules based on demonstrated efficacy should the therapy clearly prove to be beneficial. Although a post-marketing clinical study of this nature is unusual for an approved indication, this trial adheres to all ethical preconditions found in existing guidelines for clinical research involving human subjects. © The Author(s) 2014.

Detection and management of familial hypercholesterolaemia in primary care in Australia: protocol for a pragmatic cluster intervention study with pre-post intervention comparisons.

PubMed

Arnold-Reed, Diane E; Brett, Tom; Troeung, Lakkhina; Vickery, Alistair; Garton-Smith, Jacquie; Bell, Damon; Pang, Jing; Grace, Tegan; Bulsara, Caroline; Li, Ian; Bulsara, Max; Watts, Gerald F

2017-10-22

Familial hypercholesterolaemia (FH), an autosomal dominant disorder of lipid metabolism, results in accelerated onset of atherosclerosis if left untreated. Lifelong treatment with diet, lifestyle modifications and statins enable a normal lifespan for most patients. Early diagnosis is critical. This protocol trials a primary care-based model of care (MoC) to improve detection and management of FH. Pragmatic cluster intervention study with pre-post intervention comparisons in Australian general practices. At study baseline, current FH detection practice is assessed. Medical records over 2 years are electronically scanned using a data extraction tool (TARB-Ex) to identify patients at increased risk. High-risk patients are clinically reviewed to provide definitive, phenotypic diagnosis using Dutch Lipid Clinic Network Criteria. Once an index family member with FH is identified, the primary care team undertake cascade testing of first-degree relatives to identify other patients with FH. Management guidance based on disease complexity is provided to the primary care team. Study follow-up to 12 months with TARB-Ex rerun to identify total number of new FH cases diagnosed over study period (via TARB-Ex, cascade testing and new cases presenting). At study conclusion, patient and clinical staff perceptions of enablers/barriers and suggested improvements to the approach will be examined. Resources at each stage will be traced to determine the economic implications of implementing the MoC and costed from health system perspective. Primary outcomes: increase in number of index cases clinically identified; reduction in low-density lipoprotein cholesterol of treated cases. increase in the number of family cases detected/contacted; cost implications of the MoC. Study approval by The University of Notre Dame Australia Human Research Ethics Committee Protocol ID: 0 16 067F. Registration: Australian New Zealand Clinical Trials Registry ID: 12616000630415. Information will be disseminated via research seminars, conference presentations, journal articles, media releases and community forums. Australian New Zealand Clinical Trials Registry ID 12616000630415; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

38 CFR 21.5250 - Courses.

Code of Federal Regulations, 2011 CFR

2011-07-01

... REHABILITATION AND EDUCATION Post-Vietnam Era Veterans' Educational Assistance Under 38 U.S.C. Chapter 32 Courses... paragraph (c)(1))—Course and licensing and certification test approval; jurisdiction and notices. (2... 21.4267—Approval of independent study. (17) Section 21.4268—Approval of licensing and certification...

38 CFR 21.5250 - Courses.

Code of Federal Regulations, 2013 CFR

2013-07-01

... REHABILITATION AND EDUCATION Post-Vietnam Era Veterans' Educational Assistance Under 38 U.S.C. Chapter 32 Courses... paragraph (c)(1))—Course and licensing and certification test approval; jurisdiction and notices. (2... 21.4267—Approval of independent study. (17) Section 21.4268—Approval of licensing and certification...

38 CFR 21.5250 - Courses.

Code of Federal Regulations, 2014 CFR

2014-07-01

... REHABILITATION AND EDUCATION Post-Vietnam Era Veterans' Educational Assistance Under 38 U.S.C. Chapter 32 Courses... paragraph (c)(1))—Course and licensing and certification test approval; jurisdiction and notices. (2... 21.4267—Approval of independent study. (17) Section 21.4268—Approval of licensing and certification...

38 CFR 21.5250 - Courses.

Code of Federal Regulations, 2012 CFR

2012-07-01

... REHABILITATION AND EDUCATION Post-Vietnam Era Veterans' Educational Assistance Under 38 U.S.C. Chapter 32 Courses... paragraph (c)(1))—Course and licensing and certification test approval; jurisdiction and notices. (2... 21.4267—Approval of independent study. (17) Section 21.4268—Approval of licensing and certification...

38 CFR 21.5250 - Courses.

Code of Federal Regulations, 2010 CFR

2010-07-01

... REHABILITATION AND EDUCATION Post-Vietnam Era Veterans' Educational Assistance Under 38 U.S.C. Chapter 32 Courses... paragraph (c)(1))—Course and licensing and certification test approval; jurisdiction and notices. (2... 21.4267—Approval of independent study. (17) Section 21.4268—Approval of licensing and certification...

Development and Implementation of Clinical Trial Protocol Templates at the National Institute of Allergy and Infectious Diseases

PubMed Central

Bridge, Heather; Smolskis, Mary; Bianchine, Peter; Dixon, Dennis O.; Kelly, Grace; Herpin, Betsey; Tavel, Jorge

2009-01-01

Background: A clinical research protocol document must reflect both sound scientific rationale as well as local, national and, when applicable, international regulatory and human subject protections requirements. These requirements originate from a variety of sources, undergo frequent revision and are subject to interpretation. Tools to assist clinical investigators in the production of clinical protocols could facilitate navigating these requirements and ultimately increase the efficiency of clinical research. Purpose: The National Institute of Allergy and Infectious Diseases (NIAID) developed templates for investigators to serve as the foundation for protocol development. These protocol templates are designed as tools to support investigators in developing clinical protocols. Methods: NIAID established a series of working groups to determine how to improve its capacity to conduct clinical research more efficiently and effectively. The Protocol Template Working Group was convened to determine what protocol templates currently existed within NIAID and whether standard NIAID protocol templates should be produced. After review and assessment of existing protocol documents and requirements, the group reached consensus about required and optional content, determined the format and identified methods for distribution as well as education of investigators in the use of these templates. Results: The templates were approved by the NIAID Executive Committee in 2006 and posted as part of the NIAID Clinical Research Toolkit[1]website for broad access. These documents require scheduled revisions to stay current with regulatory and policy changes. Limitations: The structure of any clinical protocol template, whether comprehensive or specific to a particular study phase, setting or design, affects how it is used by investigators. Each structure presents its own set of advantages and disadvantages. While useful, protocol templates are not stand-alone tools for creating an optimal protocol document but must be complemented by institutional resources and support. Education and guidance of investigators in the appropriate use of templates is necessary to ensure a complete yet concise protocol document. Due to changing regulatory requirements, clinical protocol templates cannot become static but require frequent revisions. Conclusions: Standard protocol templates that meet applicable regulations can be important tools to assist investigators in the effective conduct of clinical research, but they require dedicated resources and ongoing input from key stakeholders. PMID:19625326

A police education programme to integrate occupational safety and HIV prevention: protocol for a modified stepped-wedge study design with parallel prospective cohorts to assess behavioural outcomes

PubMed Central

Strathdee, Steffanie A; Arredondo, Jaime; Rocha, Teresita; Abramovitz, Daniela; Rolon, Maria Luisa; Patiño Mandujano, Efrain; Rangel, Maria Gudelia; Olivarria, Horcasitas Omar; Gaines, Tommi; Patterson, Thomas L; Beletsky, Leo

2015-01-01

Introduction Policing practices are key drivers of HIV among people who inject drugs (PWID). This paper describes the protocol for the first study to prospectively examine the impact of a police education programme (PEP) to align law enforcement and HIV prevention. PEPs incorporating HIV prevention (including harm reduction programmes like syringe exchange) have been successfully piloted in several countries but were limited to brief pre–post assessments; the impact of PEPs on policing behaviours and occupational safety is unknown. Objectives Proyecto ESCUDO (SHIELD) aims to evaluate the efficacy of the PEP on uptake of occupational safety procedures, as assessed through the incidence of needle stick injuries (NSIs) (primary outcome) and changes in knowledge of transmission, prevention and treatment of HIV and viral hepatitis; attitudes towards PWID, adverse behaviours that interfere with HIV prevention and protective behaviours (secondary outcomes). Methods/analysis ESCUDO is a hybrid type I design that simultaneously tests an intervention and an implementation strategy. Using a modified stepped-wedge design involving all active duty street-level police officers in Tijuana (N=∼1200), we will administer one 3 h PEP course to groups of 20–50 officers until the entire force is trained. NSI incidence and geocoded arrest data will be assessed from department-wide de-identified data. Of the consenting police officers, a subcohort (N=500) will be randomly sampled from each class to undergo pre-PEP and post-PEP surveys with a semiannual follow-up for 2 years to assess self-reported NSIs, attitudes and behaviour changes. The impact on PWIDs will be externally validated through a parallel cohort of Tijuana PWIDs. Ethics/dissemination Research ethics approval was obtained from the USA and Mexico. Findings will be disseminated through open access to protocol materials through the Law Enforcement and HIV Network. Trial registration number NCT02444403. PMID:26260350

Automating individualized coaching and authentic role-play practice for brief intervention training.

PubMed

Hayes-Roth, B; Saker, R; Amano, K

2010-01-01

Brief intervention helps to reduce alcohol abuse, but there is a need for accessible, cost-effective training of clinicians. This study evaluated STAR Workshop , a web-based training system that automates efficacious techniques for individualized coaching and authentic role-play practice. We compared STAR Workshop to a web-based, self-guided e-book and a no-treatment control, for training the Engage for Change (E4C) brief intervention protocol. Subjects were medical and nursing students. Brief written skill probes tested subjects' performance of individual protocol steps, in different clinical scenarios, at three test times: pre-training, post-training, and post-delay (two weeks). Subjects also did live phone interviews with a standardized patient, post-delay. STAR subjects performed significantly better than both other groups. They showed significantly greater improvement from pre-training probes to post-training and post-delay probes. They scored significantly higher on post-delay phone interviews. STAR Workshop appears to be an accessible, cost-effective approach for training students to use the E4C protocol for brief intervention in alcohol abuse. It may also be useful for training other clinical interviewing protocols.

Protocol deviations before and after IV tPA in community hospitals

PubMed Central

Adelman, Eric E.; Scott, Phillip A.; Skolarus, Lesli E.; Fox, Allison K.; Frederiksen, Shirley M.; Meurer, William J.

2015-01-01

Background Protocol deviations before and after tPA treatment for ischemic stroke are common. It is unclear if patient or hospital factors predict protocol deviations. We examined predictors of protocol deviations and the effects of protocol violations on symptomatic intracerebral hemorrhage. Methods We used data from the INSTINCT trial, a cluster-randomized, controlled trial evaluating the efficacy of a barrier assessment and educational intervention to increase appropriate tPA use in 24 Michigan community hospitals, to review tPA treatments between 2007 and 2010. Protocol violations were defined as deviations from the standard tPA protocol, both before and after treatment. Multi-level logistic regression models were fitted to determine if patient and hospital variables were associated with pre-treatment or post-treatment protocol deviations. Results During the study, 557 patients (mean age 70; 52% male; median NIHSS 12) were treated with tPA. Protocol deviations occurred in 233 (42%) patients: 16% had pre-treatment deviations, 35% had post-treatment deviations, and 9% had both. The most common protocol deviations included elevated post-treatment blood pressure, antithrombotic agent use within 24 hours of treatment, and elevated pre-treatment blood pressure. Protocol deviations were not associated with symptomatic intracerebral hemorrhage, stroke severity, or hospital factors. Older age was associated with pre-treatment protocol deviations (adjusted OR 0.52; 95% confidence interval 0.30-0.92). Pre-treatment deviations were associated with post-treatment deviations (adjusted OR 3.20; 95% confidence interval 1.91-5.35). Conclusions Protocol deviations were not associated with symptomatic intracerebral hemorrhage. Aside from age, patient and hospital factors were not associated with protocol deviations. PMID:26419527

Special Plans and Operations: Assessment of Allegations Concerning Traumatic Brain Injury Research Integrity in Iraq

DTIC Science & Technology

2011-03-31

protocols conducted in Iraq. His office had been designated by the 1 A research protocol is a formal document detailing the study methodology and the...Human Research Protections Program plan requires scientific peer review to ensure that research is scientifically sound in its design and methods, and...ofthe approved research protocol and IRB minutes, revealed that there was no mention of "active rehabilitation and exercise" under the design

Assessment of the quantity of microorganisms associated with bronchiectasis in saliva, sputum and nasal lavage after periodontal treatment: a study protocol of a randomised controlled trial

PubMed Central

Pinto, Erika Horácio; Longo, Priscila Larcher; de Camargo, Caroline Cristina Batista; Dal Corso, Simone; Lanza, Fernanda De Cordoba; Stelmach, Rafael; Athanazio, Rodrigo; Fernandes, Kristianne Porta Santos; Mayer, Marcia Pinto Alves; Bussadori, Sandra Kalil; Mesquita Ferrari, Raquel Agnelli; Horliana, Anna Carolina Ratto Tempestini

2016-01-01

Introduction The association between periodontal disease (PD) and chronic obstructive pulmonary disease (COPD) has been widely studied, with aspiration of periodontal pathogens being one of the most accepted causal mechanisms for pulmonary exacerbation. Periodontal treatment (PT) was associated with a decrease in these exacerbations. Bronchiectasis is a pulmonary disease that has many similarities to COPD; however, there are no studies correlating this condition to PD thus far. This study will evaluate if PT reduces proinflammatory cytokines in serum and saliva, as well as halitosis and the amount of microorganisms associated with exacerbation of bronchiectasis in saliva, sputum and nasal lavage 3 months after PT. Methods and analysis A total of 182 patients with PD and bronchiectasis will be randomly allocated to group 1 (positive control; scaling and root planing (SRP)+oral hygiene (OH)) or group 2 (experimental; SRP+photodynamic therapy+OH). After 3 months, samples of saliva, nasal lavage and sputum will be collected to determine the level of Pseudomonas aeruginosa, Staphylococcus aureus and Porphyromonas gingivalis by quantitative PCR. This protocol will determine the efficacy of PT in reducing the most likely niches of bronchiectasis exacerbation by comparing pre- and post-treatment microbiology samples. Furthermore, there will be assessment of oral halitosis and verification of inflammatory cytokines in serum and saliva. Ethics and dissemination This protocol has been approved by the Research Ethics Committee of Universidade Nove de Julho. Data will be published in a peer-reviewed journal. Trial registration number NCT02514226. PMID:27084279

Post-approval Studies for Rare Disease Treatments and Orphan Drugs.

PubMed

Maier, William C; Christensen, Ronald A; Anderson, Patricia

2017-01-01

Drug development involves a multi-stage process of drug discovery, animal studies and human clinical trials to assess the safety and efficacy of new medications. Rare disease drug development involves a much smaller number of affected patients, a predominance of pediatric patients and more complicated disease presentation. Post-approval studies are designed to address several limitations associated with the rare disease clinical trials.National and international regulatory agencies in the US and Europe have adopted similar approaches to requirements post-approval data for rare diseases and orphan drug indications. The US FDA published guidance in 2011 and the European Medicines Agency in 2015.Post-approval studies for rare diseases include observational studies, pragmatic trials and randomized controlled studies. Observational studies include both original data collection studies and the use of secondary data (retrospective studies). Original data collection can address limitations of retrospective studies resulting from incomplete information in secondary data sources. Disease registries focus on detail about a broad range of patients with a rare disease while product-related registries focus on specific health care outcomes associated with a single product and may incorporate a comparator of an alternative therapy or therapies.Rare disease patients can be difficult to find and enroll in a registry using conventional physician based driven recruitment. The study process also needs to recognize changes in the patient's disease and lifestyle and adapt both the study design and methods over time. Many rare diseases have strong patient advocacy groups that can in aid the design and execution of rare disease registries.

A caution to Native American institutional review boards about scientism and censorship.

PubMed

Askland, Andrew

2002-01-01

Native American Institutional Review Boards (IRBs) promote the health and welfare of tribes by reviewing protocols for research studies that focus on their tribes. The benefits of approved protocols should not be overstated lest good studies disappoint because they do not satisfy unachievable expectations. IRBs also should avoid the temptation to censor the outcomes of those studies. Science relies on candor and clarity about results and methods to move forward.

Brain Consequences of Spinal Cord Injury with and without Neuropathic Pain: Translating Animal Models of Neuroinflammation onto Human Neural Networks and Back

DTIC Science & Technology

2016-10-01

During year one , we have: Obtained IRB and HRPO approval for the human studies , obtained IACUC and ACURO approval for the animal studies , refined the...human study protocol and collected PET-MR data on healthy individuals and spinal cord injured subjects, developed the rodent imaging procedures...qualtiative synthesis of the current state of the field, and 6 studies can be included in a quantitative meta-analysis. The studies eligible for inclusion in

Post-treatment surveillance testing of patients with colorectal cancer and the association with survival: protocol for a retrospective cohort study of the Surveillance, Epidemiology, and End Results (SEER)-Medicare database.

PubMed

Hines, Robert B; Jiban, Md Jibanul Haque; Choudhury, Kanak; Loerzel, Victoria; Specogna, Adrian V; Troy, Steven P; Zhang, Shunpu

2018-04-28

Although the colorectal cancer (CRC) mortality rate has significantly improved over the past several decades, many patients will have a recurrence following curative treatment. Despite this high risk of recurrence, adherence to CRC surveillance testing guidelines is poor which increases cancer-related morbidity and potentially, mortality. Several randomised controlled trials (RCTs) with varying surveillance strategies have yielded conflicting evidence regarding the survival benefit associated with surveillance testing. However, due to differences in study protocols and limitations of sample size and length of follow-up, the RCT may not be the best study design to evaluate this relationship. An observational comparative effectiveness research study can overcome the sample size/follow-up limitations of RCT designs while assessing real-world variability in receipt of surveillance testing to provide much needed evidence on this important clinical issue. The gap in knowledge that this study will address concerns whether adherence to National Comprehensive Cancer Network CRC surveillance guidelines improves survival. Patients with colon and rectal cancer aged 66-84 years, who have been diagnosed between 2002 and 2008 and have been included in the Surveillance, Epidemiology, and End Results-Medicare database, are eligible for this retrospective cohort study. To minimise bias, patients had to survive at least 12 months following the completion of treatment. Adherence to surveillance testing up to 5 years post-treatment will be assessed in each year of follow-up and overall. Binomial regression will be used to assess the association between patients' characteristics and adherence. Survival analysis will be conducted to assess the association between adherence and 5-year survival. This study was approved by the National Cancer Institute and the Institutional Review Board of the University of Central Florida. The results of this study will be disseminated by publishing in the peer-reviewed scientific literature, presentation at national/international scientific conferences and posting through social media. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Pharmacotherapeutics of Intranasal Scopolamine: FDA Regulations and Procedures for Clinical Applications

NASA Technical Reports Server (NTRS)

Das, H.; Daniels, V. R.; Vaksman, Z.; Boyd, J. L.; Buckey, J. C.; Locke, J. P.; Putcha, L.

2007-01-01

Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during the early flight days of a space mission. Bioavailability of oral (PO) SMS medications is often low and highly variable; additionally, physiological changes in a microgravity environment exacerbate variability and decrease bioavailability. These factors prompted NASA to develop an intranasal dosage form of scopolamine (INSCOP) suitable for the treatment of SMS. However, to assure safety and efficacy of treatment in space, NASA physicians prescribe commercially available pharmaceutical products only. Development of a pharmaceutical preparation for clinical use must follow distinct clinical phases of testing, phase I through IV to be exact, before it can be approved by the FDA for approval for clinical use. After a physician sponsored Investigative New Drug (IND) application was approved by the FDA, a phase I clinical trial of INSCOP formulation was completed in normal human subjects and results published. The current project includes three phase II clinical protocols for the assessment of pharmacokinetics and pharmacodynamics (PK/PD), efficacy, and safety of INSCOP. Three clinical protocols that were submitted to FDA to accomplish the project objectives: 1) 002-A, a FDA Phase II dose ranging study with four dose levels between 0.1 and 0.4 mg in 12 subjects to assess PK/PD, 2) 002-B, a phase II clinical efficacy study in eighteen healthy subjects to compare efficacy of 0.2 (low dose) and 0.4 mg (high dose) INSCOP for prophylactic treatment of motion-induces (off-axis vertical rotation) symptoms, and (3) 002-C, a phase II clinical study with twelve subjects to determine bioavailability and pharmacodynamics of two doses (0.2 and 0.4 mg) of INSCOP in simulated microgravity, antiorthostatic bedrest. All regulatory procedures were competed that include certification for Good laboratory Procedures by Theradex , clinical documentation, personnel training, selection of clinical research operations contractor, data capturing and management, and annual reporting of results to FDA were successfully completed. Protocol 002-A was completed and sample and data analysis is currently in progress. Protocol 002-B is currently in progress at Dartmouth Hitchcock Medical Center and Protocol 002-C has been submitted to the FDA and will be implemented at the same contractor site as 002-A. An annual report was filed as required by FDA on the results of Protocol 002-A. Once all the three Phase II protocols are completed, a New Drug Administration application will be filed with FDA for Phase III clinical assessment and approval for marketing of the formulation. A commercial vendor will be identified for this phase. This is critical for making this available for treatment of SMS in astronauts and military personnel on duty. Once approved by FDA, INSCOP can be also used by civilian population for motion sickness associated with recreational travel and other ailments that require treatment with anticholinergic drugs.

Region-of-interest breast images with the Twente Photoacoustic Mammoscope (PAM)

NASA Astrophysics Data System (ADS)

Manohar, Srirang; Vaartjes, Sanne E.; van Hespen, Johan G. C.; Klaase, Joost M.; van den Engh, Frank M.; The, Andy K. H.; Steenbergen, Wiendelt; van Leeuwen, Ton G.

2007-02-01

The Twente Photoacoustic Mammoscope (PAM) is based on generating laser-induced ultrasound from absorbing structures in the breast. The heart of the instrument is a flat PVDF based detector matrix comprising 590 active elements. The exciting source is an Nd:YAG laser operating at 1064 nm with 5 ns pulses. The instrument is built around a hospital bed. A study protocol was designed to explore the feasibility of using the photoacoustic technique as embodied in PAM to detect cancer in the breasts of patients with suspect/symptomatic breasts. The protocol was approved by a Medical Ethics testing committee and the instrument approved for laser and electrical safety. The protocol was executed at the Medisch Spectrum Twente by using the mammoscope to obtain photoacoustic region-of-interest (ROI) images of the suspect/symptomatic breasts. We report on one case and compare the photoacoustic images obtained with x-ray mammograms and ultrasound images.

Effect modification of FADS2 polymorphisms on the association between breastfeeding and intelligence: protocol for a collaborative meta-analysis.

PubMed

Hartwig, Fernando Pires; Davies, Neil Martin; Horta, Bernardo Lessa; Victora, Cesar Gomes; Davey Smith, George

2016-06-15

Evidence from observational studies and randomised controlled trials suggests that breastfeeding is positively associated with IQ, possibly because breast milk is a source of long-chain polyunsaturated fatty acids. Different studies have detected gene-breastfeeding interactions involving FADS2 variants and intelligence. However, findings are inconsistent regarding the direction of such effect modification. To clarify how FADS2 and breastfeeding interact in their association with IQ, we are conducting a consortium-based meta-analysis of independent studies. Results produced by each individual study using standardised analysis scripts and harmonised data will be used. breastfeeding, IQ and either rs174575 or rs1535 polymorphisms available; and being of European ancestry. twin studies; only poorly imputed genetic data available; or unavailability of proper ethics approval. Studies will be invited based on being known to have at least some of the required data, or suggested by participating studies as potentially eligible. This inclusive approach will favour achieving a larger sample size and be less prone to publication bias. Improving current understanding of FADS2-breastfeeding interaction may provide important biological insights regarding the importance of long-chain polyunsaturated fatty acids for the breastfeeding-IQ association. This meta-analysis will help to improve such knowledge by replicating earlier studies, conducting additional analysis and evaluating different sources of heterogeneity. Publishing this protocol will minimise the possibility of bias due to post hoc changes to the analysis protocol. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

PubMed Central

Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

2017-01-01

Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the sponsor. High remuneration and strict confidentiality clauses in these studies could influence the physicians’ reporting behaviours of adverse drug reactions. PMID:28174182

Perceived effects of the economic recession on population mental health, well-being and provision of care by primary care users and professionals: a qualitative study protocol in Portugal.

PubMed

Antunes, Ana; Frasquilho, Diana; Cardoso, Graça; Pereira, Nádia; Silva, Manuela; Caldas-de-Almeida, José Miguel; Ferrão, João

2017-09-03

Economic recession periods can pose accentuated risks to population's mental health and well-being as well as additional threats to health systems. Users and health professionals are key stakeholders in care delivery; however, little attention has been given to their experiences of the crisis. This paper presents a qualitative study protocol to assess users' and health professionals' perceptions about the effects of the post-2008 economic recession on mental health and care delivery in the Lisbon Metropolitan Area, Portugal. The methodology to assess perceived effects of the economic recession by primary care users and professionals on population mental health, well-being and provision of care is presented. Focus groups with users and semistructured interviews with health professionals will be carried out in three primary healthcare units in Lisbon areas especially affected by the crisis. Thematic analysis of full-transcribed interviews will be conducted using an iterative and reflexive approach. The study protocol was approved by the Ethics Committee of NOVA Medical School, NOVA University of Lisbon. The findings will be useful for other researchers and policy-makers to develop and implement the assessment of prevailing experiences of users and health professionals on the effects of the economic recession on mental health and quality of care in primary health context, promoting their involvement and contribution to services responsiveness. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Impact of a pharmacist-driven warfarin management protocol on achieving therapeutic International Normalized Ratios.

PubMed

Downing, Amanda; Mortimer, Molly; Hiers, Jill

2016-03-01

Warfarin is a high alert medication and a challenge to dose and monitor. Pharmacist-driven warfarin management has been shown to decrease the time international normalized ratio (INR) is out of range, which may reduce undesired outcomes. The purpose of this study is to assess the effect of the implementation of a pharmacist-driven warfarin management protocol on the achievement of therapeutic INRs. A warfarin management protocol was developed using evidence based literature and similar protocols from other institutions. Pharmacists utilized the protocol to provide patient specific warfarin dosing upon provider referral. To evaluate the protocol's impact, a retrospective chart review pre- and post-implementation was completed for admitted patients receiving warfarin. Three hundred twenty-seven charts were reviewed for pre- and post-implementation data. INRs within therapeutic range increased from 27.8% before protocol implementation to 38.5% after implementation. There was also a reduction in subtherapeutic INRs (55.3% pre to 39% post) and supratherapeutic INRs 5 or above (3.7% pre to 2.6% post). Supratherapeutic INRs between 3 and 5 did increase from 13.2% before protocol implementation to 19.9% in the pharmacist managed group. In addition to reducing the time to achievement of therapeutic INRs by 0.5 days, implementation of the protocol resulted in an increased the number of patients with at least one therapeutic INR during admission (35% pre to 40% post). The implementation of a pharmacist-driven warfarin dosing protocol increased therapeutic INRs, and decreased the time to therapeutic range, as well as the proportion of subtherapeutic INRs and supratherapeutic INRs 5 or greater. Additional benefits of the protocol include documentation of Joint Commission National Patient Safety Goal compliance, promotion of interdisciplinary collaboration and increased continuity of care. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Pre-clinical evaluation of a nanoparticle-based blood-pool contrast agent for MR imaging of the placenta.

PubMed

Ghaghada, Ketan B; Starosolski, Zbigniew A; Bhayana, Saakshi; Stupin, Igor; Patel, Chandreshkumar V; Bhavane, Rohan C; Gao, Haijun; Bednov, Andrey; Yallampalli, Chandrasekhar; Belfort, Michael; George, Verghese; Annapragada, Ananth V

2017-09-01

Non-invasive 3D imaging that enables clear visualization of placental margins is of interest in the accurate diagnosis of placental pathologies. This study investigated if contrast-enhanced MRI performed using a liposomal gadolinium blood-pool contrast agent (liposomal-Gd) enables clear visualization of the placental margins and the placental-myometrial interface (retroplacental space). Non-contrast MRI and contrast-enhanced MRI using a clinically approved conventional contrast agent were used as comparators. Studies were performed in pregnant rats under an approved protocol. MRI was performed at 1T using a permanent magnet small animal scanner. Pre-contrast and post-liposomal-Gd contrast images were acquired using T1-weighted and T2-weighted sequences. Dynamic Contrast enhanced MRI (DCE-MRI) was performed using gadoterate meglumine (Gd-DOTA, Dotarem ® ). Visualization of the retroplacental clear space, a marker of normal placentation, was judged by a trained radiologist. Signal-to-noise (SNR) and contrast-to-noise (CNR) ratios were calculated for both single and averaged acquisitions. Images were reviewed by a radiologist and scored for the visualization of placental features. Contrast-enhanced CT (CE-CT) imaging using a liposomal CT agent was performed for confirmation of the MR findings. Transplacental transport of liposomal-Gd was evaluated by post-mortem elemental analysis of tissues. Ex-vivo studies in perfused human placentae from normal, GDM, and IUGR pregnancies evaluated the transport of liposomal agent across the human placental barrier. Post-contrast T1w images acquired with liposomal-Gd demonstrated significantly higher SNR (p = 0.0002) in the placenta compared to pre-contrast images (28.0 ± 4.7 vs. 6.9 ± 1.8). No significant differences (p = 0.39) were noted between SNR in pre-contrast and post-contrast liposomal-Gd images of the amniotic fluid, indicating absence of transplacental passage of the agent. The placental margins were significantly (p < 0.001) better visualized on post-contrast liposomal-Gd images. DCE-MRI with the conventional Gd agent demonstrated retrograde opacification of the placenta from fetal edge to the myometrium, consistent with the anatomy of the rat placenta. However, no consistent and reproducible visualization of the retroplacental space was demonstrated on the conventional Gd-enhanced images. The retroplacental space was only visualized on post-contrast T1w images acquired using the liposomal agent (SNR = 15.5 ± 3.4) as a sharply defined, hypo-enhanced interface. The retroplacental space was also visible as a similar hypo-enhancing interface on CE-CT images acquired using a liposomal CT contrast agent. Tissue analysis demonstrated undetectably low transplacental permeation of liposomal-Gd, and was confirmed by lack of permeation through a perfused human placental model. Contrast-enhanced T1w-MRI performed using liposomal-Gd enabled clear visualization of placental margins and delineation of the retroplacental space from the rest of the placenta; the space is undetectable on non-contrast imaging and on post-contrast T1w images acquired using a conventional, clinically approved Gd chelate contrast agent. Copyright © 2017 Elsevier Ltd. All rights reserved.

Arts-based HIV and STI prevention intervention with Northern and Indigenous youth in the Northwest Territories: study protocol for a non-randomised cohort pilot study.

PubMed

Lys, Candice; Logie, Carmen H; MacNeill, Nancy; Loppie, Charlotte; Dias, Lisa V; Masching, Renée; Gesink, Dionne

2016-10-03

Indigenous youth are disproportionately represented in new HIV infection rates in Canada. Current and historical contexts of colonisation and racism, disconnection from culture and land, as well as intergenerational trauma resulting from the legacy of residential schools are social drivers that elevate exposure to HIV among Indigenous peoples. Peer-education and arts-based interventions are increasingly used for HIV prevention with youth. Yet limited studies have evaluated longitudinal effects of arts-based approaches to HIV prevention with youth. The authors present a rationale and study protocol for an arts-based HIV prevention intervention with Northern and Indigenous youth in the Northwest Territories (NWT), Canada. This is a multicentre non-randomised cohort pilot study using a pretest/post-test design with a 12-month follow-up. The target population is Northern and Indigenous youth in 18 communities in the NWT. The aim is to recruit 150 youth using venue-based sampling at secondary schools. Participants will be involved in an arts-based intervention, Fostering Open eXpression among Youth (FOXY). Participants will complete a pretest, post-test survey directly following the intervention, and a 12-month follow-up. The primary outcome is new or enhanced HIV knowledge, and secondary outcomes to include: new or enhanced sexually transmitted infections knowledge, and increased self-esteem, resilience, empowerment, safer sex self-efficacy and cultural connectedness. Mixed effects regression analyses will be conducted to evaluate pretest and post-test differences in outcome measurement scores. This study has received approval from the HIV Research Ethics Board at the University of Toronto (REB: 31602). In addition, the project is currently registered in the NWT with the Aurora Research Institute (Licence: 15741). Trial results will be published according to the Transparent Reporting of Evaluations with Nonrandomised Designs statement. NCT02743026; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

21 CFR 814.19 - Product development protocol (PDP).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Product development protocol (PDP). 814.19 Section...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.19 Product development protocol (PDP). A class III device for which a product development protocol has been declared completed by FDA under...

21 CFR 814.19 - Product development protocol (PDP).

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Product development protocol (PDP). 814.19 Section...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.19 Product development protocol (PDP). A class III device for which a product development protocol has been declared completed by FDA under...

An investigation into the nutritional status of patients receiving an Enhanced Recovery After Surgery (ERAS) protocol versus standard care following Oesophagectomy.

PubMed

Benton, Katie; Thomson, Iain; Isenring, Elisabeth; Mark Smithers, B; Agarwal, Ekta

2018-06-01

Enhanced Recovery After Surgery (ERAS) protocols have been effectively expanded to various surgical specialities including oesophagectomy. Despite nutrition being a key component, actual nutrition outcomes and specific guidelines are lacking. This cohort comparison study aims to compare nutritional status and adherence during implementation of a standardised post-operative nutritional support protocol, as part of ERAS, compared to those who received usual care. Two groups of patients undergoing resection of oesophageal cancer were studied. Group 1 (n = 17) underwent oesophagectomy between Oct 2014 and Nov 2016 during implementation of an ERAS protocol. Patients in group 2 (n = 16) underwent oesophagectomy between Jan 2011 and Dec 2012 prior to the implementation of ERAS. Demographic, nutritional status, dietary intake and adherence data were collected. Ordinal data was analysed using independent t tests, and categorical data using chi-square tests. There was no significant difference in nutrition status, dietary intake or length of stay following implementation of an ERAS protocol. Malnutrition remained prevalent in both groups at day 42 post surgery (n = 10, 83% usual care; and n = 9, 60% ERAS). A significant difference was demonstrated in adherence with earlier initiation of oral free fluids (p <0.008), transition to soft diet (p <0.004) and continuation of jejunostomy feeds on discharge (p <0.000) for the ERAS group. A standardised post-operative nutrition protocol, within an ERAS framework, results in earlier transition to oral intake; however, malnutrition remains prevalent post surgery. Further large-scale studies are warranted to examine individualised decision-making regarding nutrition support within an ERAS protocol.

Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight.

PubMed

Engel, Pierre; Almas, Mariana Ferreira; De Bruin, Marieke Louise; Starzyk, Kathryn; Blackburn, Stella; Dreyer, Nancy Ann

2017-04-01

To describe and characterize the first cohort of Post-Authorization Safety Study (PASS) protocols reviewed under the recent European pharmacovigilance legislation. A systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted from July 2012 to July 2015 from Pharmacovigilance Risk Assessment Committee (PRAC) minutes, European Medicines Agency (EMA) and European Network of Pharmacovigilance and Pharmacoepidemiology (ENCePP) webpages. During the study period, 189 different PASS protocols were submitted to the PRAC, half of which were entered in the ENCePP electronic register of post-authorization studies (EU-PAS) by July 2015. Those protocols were assessed during 353 PRAC reviews. The EMA published only 31% of the PRAC feedback, of which the main concerns were study design (37%) and feasibility (30%). Among the 189 PASS, slightly more involved primary data capture (58%). PASS assessing drug utilization mainly leveraged secondary data sources (58%). The majority of the PASS did not include a comparator (65%) and 35% of PASS also evaluated clinical effectiveness endpoints. To the best of our knowledge this is the first comprehensive review of three years of PASS protocols submitted under the new pharmacovigilance legislation. Our results show that both EMA and PASS sponsors could respectively increase the availability of protocol assessments and documents in the EU-PAS. Protocol content review and the high number of PRAC comments related to methodological issues and feasibility concerns should raise awareness among PASS stakeholders to design more thoughtful studies according to pharmacoepidemiological principles and existing guidelines. © 2016 The British Pharmacological Society.

Investigation of the Study Characteristics Affecting Clinical Trial Quality Using the Protocol Deviations Leading to Exclusion of Subjects From the Per Protocol Set Data in Studies for New Drug Application: A Retrospective Analysis.

PubMed

Kohara, Norihito; Kaneko, Masayuki; Narukawa, Mamoru

2018-01-01

The concept of the risk-based approach has been introduced as an effort to secure the quality of clinical trials. In the risk-based approach, identification and evaluation of risk in advance are considered important. For recently completed clinical trials, we investigated the relationship between study characteristics and protocol deviations leading to the exclusion of subjects from Per Protocol Set (PPS) efficacy analysis. New drugs approved in Japan in the fiscal year 2014-2015 were targeted in the research. The reasons for excluding subjects from the PPS efficacy analysis were described in 102 trials out of 492 in the summary of new drug application documents, which was publicly disclosed after the drug's regulatory approval. The author extracted these reasons along with the numbers of the cases and the study characteristics of each clinical trial. Then, the direct comparison, univariate regression analysis, and multivariate regression analysis was carried out based on the exclusion rate. The study characteristics for which exclusion of subjects from the PPS efficacy analysis were frequently observed was multiregional clinical trials in study region; inhalant and external use in administration route; Anti-infective for systemic use; Respiratory system, Dermatologicals, and Nervous system in therapeutic drug under the Anatomical Therapeutic Chemical Classification. In the multivariate regression analysis, the clinical trial variables of inhalant, Respiratory system, or Dermatologicals were selected as study characteristics leading to a higher exclusion rate. The characteristics of the clinical trial that is likely to cause protocol deviations that will affect efficacy analysis were suggested. These studies should be considered for specific attention and priority observation in the trial protocol or its monitoring plan and execution, such as a clear description of inclusion/exclusion criteria in the protocol, development of training materials to site staff, and/or trial subjects as specific risk-alleviating measures.

Resistance to compression of weakened roots subjected to different root reconstruction protocols

PubMed Central

ZOGHEIB, Lucas Villaça; SAAVEDRA, Guilherme de Siqueira Ferreira Anzaloni; CARDOSO, Paula Elaine; VALERA, Márcia Carneiro; de ARAÚJO, Maria Amélia Máximo

2011-01-01

Objective This study evaluated, in vitro, the fracture resistance of human non-vital teeth restored with different reconstruction protocols. Material and methods Forty human anterior roots of similar shape and dimensions were assigned to four groups (n=10), according to the root reconstruction protocol: Group I (control): non-weakened roots with glass fiber post; Group II: roots with composite resin by incremental technique and glass fiber post; Group III: roots with accessory glass fiber posts and glass fiber post; and Group IV: roots with anatomic glass fiber post technique. Following post cementation and core reconstruction, the roots were embedded in chemically activated acrylic resin and submitted to fracture resistance testing, with a compressive load at an angle of 45º in relation to the long axis of the root at a speed of 0.5 mm/min until fracture. All data were statistically analyzed with bilateral Dunnett's test (α=0.05). Results Group I presented higher mean values of fracture resistance when compared with the three experimental groups, which, in turn, presented similar resistance to fracture among each other. None of the techniques of root reconstruction with intraradicular posts improved root strength, and the incremental technique was suggested as being the most recommendable, since the type of fracture that occurred allowed the remaining dental structure to be repaired. Conclusion The results of this in vitro study suggest that the healthy remaining radicular dentin is more important to increase fracture resistance than the root reconstruction protocol. PMID:22231002

Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.

PubMed

Jokura, Yoji; Yano, Kazuo; Yamato, Masayuki

2018-02-01

Legislation for expedited-approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited-approval pathways, and obligations to collect and report post-marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time-limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre- or post-marketing clinical data. Expedited-approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post-marketing study for conditional and time-limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited-approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd.

Does the age of acute care physicians impact their (1) crisis management performance and (2) learning after simulation-based education? A protocol for a multicentre prospective cohort study in Toronto and Ottawa, Canada.

PubMed

Alam, Fahad; LeBlanc, Vicki R; Baxter, Alan; Tarshis, Jordan; Piquette, Dominique; Gu, Yuqi; Filipkowska, Caroline; Krywenky, Ashley; Kester-Greene, Nicole; Cardinal, Pierre; Au, Shelly; Lam, Sandy; Boet, Sylvain; Clinical Trials Group, Perioperative Anesthesia

2018-04-21

The proportion of older acute care physicians (ACPs) has been steadily increasing. Ageing is associated with physiological changes and prospective research investigating how such age-related physiological changes affect clinical performance, including crisis resource management (CRM) skills, is lacking. There is a gap in the literature on whether physician's age influences baseline CRM performance and also learning from simulation. We aim to investigate whether ageing is associated with baseline CRM skills of ACPs (emergency, critical care and anaesthesia) using simulated crisis scenarios and to assess whether ageing influences learning from simulation-based education. This is a prospective cohort multicentre study recruiting ACPs from the Universities of Toronto and Ottawa, Canada. Each participant will manage an advanced cardiovascular life support crisis-simulated scenario (pretest) and then be debriefed on their CRM skills. They will then manage another simulated crisis scenario (immediate post-test). Three months after, participants will return to manage a third simulated crisis scenario (retention post-test). The relationship between biological age and chronological age will be assessed by measuring the participants CRM skills and their ability to learn from high-fidelity simulation. This protocol was approved by Sunnybrook Health Sciences Centre Research Ethics Board (REB Number 140-2015) and the Ottawa Health Science Network Research Ethics Board (#20150173-01H). The results will be disseminated in a peer-reviewed journal and at scientific meetings. NCT02683447; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The Renin-Angiotensin System, Not the Kinin-Kallikrein System, Affects Post-Exercise Proteinuria.

PubMed

Koçer, Günnur; Basralı, Filiz; Kuru, Oktay; Şentürk, Ümit Kemal

2018-05-17

Temporary proteinuria post-exercise is common and is caused predominantly by renal haemodynamic alterations. One reason is up-regulation of angiotensin II (Ang II) due to the reducing effect of angiotensin-converting enzyme (ACE) inhibitors. However, another, ignored, reason could be the kininase effect of ACE inhibition. This study investigated how ACE inhibition reduces post-exercise proteinuria: by either Ang II up-regulation inhibition or bradykinin elevation due to kininase activity inhibition. Our study included 10 volunteers, who completed 3 high-intensity exercise protocols involving cycling at 1-week intervals. The first protocol was a control arm, the second evaluated the effect of ACE inhibition and the third examined the effect of angiotensin type 1 receptor blockade. Upon application, both agents reduced systolic and diastolic blood pressure; however, there were no statistically significant -differences. In addition, total protein, microalbumin and -β2-microglobulin excretion levels in urine specimens were analysed before, 30 min after and 120 min after the exercise protocols. Total protein levels in urine samples were elevated in all 3 protocols after 30 min of high-intensity exercise, compared to baseline levels. However, both ACE inhibition and angiotensin type 1 receptor blockade suppressed total protein in the 30th min. In each protocol, total protein levels returned to the baseline after 120 min. Urinary microalbumin and β2-microglobulin levels during the control protocol were significantly higher 30 min post-exercise; however, only angiotensin type 1 receptor blockade suppressed microalbumin levels. The results indicated Ang II up-regulation, not bradykinin elevation, plays a role in post-exercise proteinuria. © 2018 S. Karger AG, Basel.

Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

PubMed Central

Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S

2015-01-01

Aims Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). Methods We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA’s 210 day regulatory deadline. Results Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276–406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Conclusions Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. PMID:25808713

Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.

PubMed

Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S

2015-10-01

Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA's 210 day regulatory deadline. Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276-406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. © 2015 The British Pharmacological Society.

Discovery of Novel Gene Elements Associated with Prostate Cancer Progression

DTIC Science & Technology

2014-12-01

consent under an Institutional Review Board (IRB) approved protocol at the University of Michigan [SPORE in Prostate Cancer (Tissue/Serum/Urine) Bank IRB...1994-0481]. For the Weill Cornell Medical College patient samples, prostate tissues were collected as part of an IRB- approved protocol at Weill...PCAT-1 or nontargeting short hairpin RNA (shRNA) lentiviral constructs for 48 hours. GFPþ cells were drug -selected using 1 mg/mL puromycin. PCAT-1

Protocol for a pre-implementation and post-implementation study on shared decision-making in the surgical treatment of women with early-stage breast cancer.

PubMed

Savelberg, Wilma; Moser, Albine; Smidt, Marjolein; Boersma, Liesbeth; Haekens, Christel; van der Weijden, Trudy

2015-03-31

The majority of patients diagnosed with early-stage breast cancer are in a position to choose between having a mastectomy or lumpectomy with radiation therapy (breast-conserving therapy). Since the long-term survival rates for mastectomy and for lumpectomy with radiation therapy are comparable, patients' informed preferences are important for decision-making. Although most clinicians believe that they do include patients in the decision-making process, the information that women with breast cancer receive regarding the surgical options is often rather subjective, and does not invite patients to express their preferences. Shared decision-making (SDM) is meant to help patients clarify their preferences, resulting in greater satisfaction with their final choice. Patient decision aids can be very supportive in SDM. We present the protocol of a study to β test a patient decision aid and optimise strategies for the implementation of SDM regarding the treatment of early-stage breast cancer in the actual clinical setting. This paper concerns a pre-implementation and post-implementation study, lasting from October 2014 to June 2015. The intervention consists of implementing SDM using a patient decision aid. The intervention will be evaluated using qualitative and quantitative measures, acquired prior to, during and after the implementation of SDM. Outcome measures are knowledge about treatment, perceived SDM and decisional conflict. We will also conduct face-to-face interviews with a sample of these patients and their care providers, to assess their experiences with the implementation of SDM and the patient decision aid. This protocol was approved by the Maastricht University Medical Centre (MUMC) ethics committee. The findings will be disseminated through peer-reviewed journal articles and presentations at national conferences. Findings will be used to finalise a multi-faceted implementation strategy to test the implementation of SDM and a patient decision aid in terms of cost-effectiveness, in a multicentre cluster randomised controlled trial (RCT). NTR4879. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

24 CFR 570.461 - Post-preliminary approval requirements; lead-based paint.

Code of Federal Regulations, 2011 CFR

2011-04-01

... requirements; lead-based paint. 570.461 Section 570.461 Housing and Urban Development Regulations Relating to... GRANTS Urban Development Action Grants § 570.461 Post-preliminary approval requirements; lead-based paint. The recipient may receive preliminary approval prior to the accomplishment of lead-based paint...

24 CFR 570.461 - Post-preliminary approval requirements; lead-based paint.

Code of Federal Regulations, 2013 CFR

2013-04-01

... requirements; lead-based paint. 570.461 Section 570.461 Housing and Urban Development Regulations Relating to... GRANTS Urban Development Action Grants § 570.461 Post-preliminary approval requirements; lead-based paint. The recipient may receive preliminary approval prior to the accomplishment of lead-based paint...

24 CFR 570.461 - Post-preliminary approval requirements; lead-based paint.

Code of Federal Regulations, 2012 CFR

2012-04-01

... requirements; lead-based paint. 570.461 Section 570.461 Housing and Urban Development Regulations Relating to... GRANTS Urban Development Action Grants § 570.461 Post-preliminary approval requirements; lead-based paint. The recipient may receive preliminary approval prior to the accomplishment of lead-based paint...

24 CFR 570.461 - Post-preliminary approval requirements; lead-based paint.

Code of Federal Regulations, 2014 CFR

2014-04-01

... requirements; lead-based paint. 570.461 Section 570.461 Housing and Urban Development Regulations Relating to... GRANTS Urban Development Action Grants § 570.461 Post-preliminary approval requirements; lead-based paint. The recipient may receive preliminary approval prior to the accomplishment of lead-based paint...

24 CFR 570.461 - Post-preliminary approval requirements; lead-based paint.

Code of Federal Regulations, 2010 CFR

2010-04-01

... requirements; lead-based paint. 570.461 Section 570.461 Housing and Urban Development Regulations Relating to... GRANTS Urban Development Action Grants § 570.461 Post-preliminary approval requirements; lead-based paint. The recipient may receive preliminary approval prior to the accomplishment of lead-based paint...

Ex post facto assessment of diffusion tensor imaging metrics from different MRI protocols: preparing for multicentre studies in ALS.

PubMed

Rosskopf, Johannes; Müller, Hans-Peter; Dreyhaupt, Jens; Gorges, Martin; Ludolph, Albert C; Kassubek, Jan

2015-03-01

Diffusion tensor imaging (DTI) for assessing ALS-associated white matter alterations has still not reached the level of a neuroimaging biomarker. Since large-scale multicentre DTI studies in ALS may be hampered by differences in scanning protocols, an approach for pooling of DTI data acquired with different protocols was investigated. Three hundred and nine datasets from 170 ALS patients and 139 controls were collected ex post facto from a monocentric database reflecting different scanning protocols. A 3D correction algorithm was introduced for a combined analysis of DTI metrics despite different acquisition protocols, with the focus on the CST as the tract correlate of ALS neuropathological stage 1. A homogenous set of data was obtained by application of 3D correction matrices. Results showed that a fractional anisotropy (FA) threshold of 0.41 could be defined to discriminate ALS patients from controls (sensitivity/specificity, 74%/72%). For the remaining test sample, sensitivity/specificity values of 68%/74% were obtained. In conclusion, the objective was to merge data recorded with different DTI protocols with 3D correction matrices for analyses at group level. These post processing tools might facilitate analysis of large study samples in a multicentre setting for DTI analysis at group level to aid in establishing DTI as a non-invasive biomarker for ALS.

What "likes" have got to do with it: Exposure to peers' alcohol-related posts and perceptions of injunctive drinking norms.

PubMed

Boyle, Sarah C; Smith, Daniel J; Earle, Andrew M; LaBrie, Joseph W

2018-01-01

Examine 1) whether observed social reinforcements (i.e., "likes") received by peers' alcohol-related social media posts are related to first-year college students' perceptions of peer approval for risky drinking behaviors; and 2) whether associations are moderated by students' alcohol use status. First-year university students (N = 296) completed an online survey in September, 2014. Participants reported their own alcohol use, friends' alcohol use, perceptions of the typical student's approval for risky drinking, and ranked 10 types of social media posts in terms of the relative numbers of "likes" received when posted by peers. Observed social reinforcement (i.e., "likes") for peers' alcohol-related posts predicted perceptions of peer approval for risky drinking behaviors among non-drinking students, but not drinking students. For first-year college students who have not yet initiated drinking, observing peers' alcohol-related posts to receive abundant "likes" may increase perceptions of peer approval for risky drinking.

Protocols for Automated Protist Analysis

DTIC Science & Technology

2011-12-01

Report No: CG-D-14-13 Protocols for Automated Protist Analysis December 2011 Distribution Statement A: Approved for public...release; distribution is unlimited. Protocols for Automated Protist Analysis ii UNCLAS//Public | CG-926 RDC | B. Nelson, et al. | Public...Director United States Coast Guard Research & Development Center 1 Chelsea Street New London, CT 06320 Protocols for Automated Protist Analysis

Effects of two different post-surgical protocols including either 0.05 % chlorhexidine herbal extract or 0.1 % chlorhexidine on post-surgical plaque control, early wound healing and patient acceptance following standard periodontal surgery and implant placement.

PubMed

Laugisch, Oliver; Ramseier, Christoph A; Salvi, Giovanni E; Hägi, Tobias T; Bürgin, Walter; Eick, Sigrun; Sculean, Anton

2016-11-01

The aim of this study was to compare early wound healing, tooth staining and patient acceptance with two different post-surgical maintenance protocols. Forty patients scheduled for flap surgery to treat periodontal pockets or accommodate dental implants were randomly assigned to receive the following two different post-surgical maintenance protocols: (a) 2 weeks rinsing with a 0.05 % chlorhexidine digluconate (CHX)/herbal extract combination (test) or (b) a 0.1 % CHX solution (control). Early wound healing was evaluated clinically and immunologically. Tooth staining and patient acceptance were assessed by means of visual analogue scale (VAS). Both groups presented with comparable wound healing profiles. No statistically significant differences were observed between the two protocols regarding early wound healing and plaque index (p > 0.05). However, in the control group, statistically significantly more patients felt discomfort due to tooth staining (p = 0.0467). Compared with patients from the test group, patients in the control group reported statistically significant more irritation of taste at week 1 (p = 0.0359) and at week 2 (p = 0.0042). The present findings indicate that the two CHX protocols resulted in comparable healing and inhibition of plaque formation. Tooth staining and subjective discomfort related to irritation of taste were more frequent in the control group. A post-operative protocol including 0.05 % CHX/herbal extract may have the potential to improve patient compliance during post-operative maintenance.

30 CFR 550.282 - Do I have to conduct post-approval monitoring?

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 2 2013-07-01 2013-07-01 false Do I have to conduct post-approval monitoring... INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and Information... monitoring? After approving your EP, DPP, or DOCD, the Regional Supervisor may direct you to conduct...

30 CFR 550.282 - Do I have to conduct post-approval monitoring?

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 2 2014-07-01 2014-07-01 false Do I have to conduct post-approval monitoring... INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and Information... monitoring? After approving your EP, DPP, or DOCD, the Regional Supervisor may direct you to conduct...

30 CFR 550.282 - Do I have to conduct post-approval monitoring?

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 2 2012-07-01 2012-07-01 false Do I have to conduct post-approval monitoring... INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and Information... monitoring? After approving your EP, DPP, or DOCD, the Regional Supervisor may direct you to conduct...

Assessing How Hospital Readmission are Affected by Obstructive Sleep Apnea Severity and Therapy Compliance

DTIC Science & Technology

2017-06-03

evaluation study, informational report/briefing, etc.) in the "Protocol Title" box. 4. Attach a copy of your abstract. paper, poster and other...approval or disapproval. 9. Once your manuscript, poster or presentation has been approved for a one-time public release, you may proceed with your...Presentation and Publication of Medical and Technical Papers, for additional information. NOTE: All abstracts. papers, posters , etc .. should contain the

How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review

PubMed Central

Kramer, Daniel B.; Xu, Shuai; Kesselheim, Aaron S.

2012-01-01

Background Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings. Methods and Findings We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys. Conclusions Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting. Please see later in the article for the Editors' Summary. PMID:22912563

Study protocol for a randomised controlled trial of cognitive processing therapy for post-traumatic stress disorder among Japanese patients: the Safety, Power, Intimacy, Esteem, Trust (SPINET) study

PubMed Central

Ito, Masaya; Horikoshi, Masaru; Resick, Patricia A; Katayanagi, Akiko; Miyamae, Mitsuhiro; Takagishi, Yuriko; Takebayashi, Yoshitake; Kanie, Ayako; Hirabayashi, Naotsugu; Furukawa, Toshiaki A

2017-01-01

Introduction Cognitive processing therapy (CPT) is widely regarded as a safe and effective first-line treatment for individuals with post-traumatic stress disorder (PTSD); however, no comparative studies have been conducted to examine the treatment outcomes in an Asian population. The aim of the present trial is to investigate the efficacy of CPT (individual format) as a treatment for PTSD in a population of Japanese patients. Methods and analysis A 16-week, single-centre, assessor-masked, randomised, parallel-group superiority trial has been designed to compare the efficacy of CPT in conjunction with treatment as usual (mostly pharmacotherapy and clinical monitoring) versus treatment as usual alone. The Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) will be our primary outcome measure of the post-traumatic stress symptoms at 17 weeks, whereas the PTSD Checklist for DSM-5 and determination of the operationally defined responder status will be used to assess the secondary outcomes. An estimated sample size of 29 participants in each group will be required to detect an expected effect size of 1.4 (95% CI 0.85 to 1.95). Ethics and dissemination The institutional review board at the National Center of Neurology and Psychiatry in Japan approved this study. The results of this clinical trial will be presented at conferences and disseminated through publication in a peer-reviewed journal. Trial registration number UMIN000021670 (registered on 1 April 2016). PMID:28667201

Improving swallowing outcomes in patients with head and neck cancer using a theory-based pretreatment swallowing intervention package: protocol for a randomised feasibility study

PubMed Central

Smith, Christina H; Barratt, Helen; Taylor, Stuart A

2017-01-01

Introduction The incidence of head and neck cancer (HNC) in the UK is rising, with an average of 31 people diagnosed daily. Patients affected by HNC suffer significant short-term and long-term post-treatment morbidity as a result of dysphagia, which affects daily functioning and quality of life (QOL). Pretreatment swallowing exercises may provide additional benefit over standard rehabilitation in managing dysphagia after primary HNC treatments, but uncertainty about their effectiveness persists. This study was preceded by an intervention development phase to produce an optimised swallowing intervention package (SIP). The aim of the current study is to assess the feasibility of this new intervention and research processes within a National Health Service (NHS) setting. Method and analysis A two-arm non-blinded randomised controlled feasibility study will be carried out at one tertiary referral NHS centre providing specialist services in HNC. Patients newly diagnosed with stage III and IV disease undergoing planned surgery and/or chemoradiation treatments will be eligible. The SIP will be delivered pre treatment, and a range of swallowing-related and QOL measures will be collected at baseline, 1, 3 and 6 months post-treatment. Outcomes will test the feasibility of a future randomised controlled trial (RCT), detailing rate of recruitment and patient acceptance to participation and randomisation. Salient information relating to protocol implementation will be collated and study material such as the case report form will be tested. A range of candidate outcome measures will be examined for suitability in a larger RCT. Ethics and dissemination Ethical approval was obtained from an NHS Research Ethics Committee. Findings will be published open access in a peer-reviewed journal, and presented at relevant conferences and research meetings. Trial registration number ISRCTN40215425; Pre-results. PMID:28348190

Improving swallowing outcomes in patients with head and neck cancer using a theory-based pretreatment swallowing intervention package: protocol for a randomised feasibility study.

PubMed

Govender, Roganie; Smith, Christina H; Gardner, Benjamin; Barratt, Helen; Taylor, Stuart A

2017-03-27

The incidence of head and neck cancer (HNC) in the UK is rising, with an average of 31 people diagnosed daily. Patients affected by HNC suffer significant short-term and long-term post-treatment morbidity as a result of dysphagia, which affects daily functioning and quality of life (QOL). Pretreatment swallowing exercises may provide additional benefit over standard rehabilitation in managing dysphagia after primary HNC treatments, but uncertainty about their effectiveness persists. This study was preceded by an intervention development phase to produce an optimised swallowing intervention package (SIP). The aim of the current study is to assess the feasibility of this new intervention and research processes within a National Health Service (NHS) setting. A two-arm non-blinded randomised controlled feasibility study will be carried out at one tertiary referral NHS centre providing specialist services in HNC. Patients newly diagnosed with stage III and IV disease undergoing planned surgery and/or chemoradiation treatments will be eligible. The SIP will be delivered pre treatment, and a range of swallowing-related and QOL measures will be collected at baseline, 1, 3 and 6 months post-treatment. Outcomes will test the feasibility of a future randomised controlled trial (RCT), detailing rate of recruitment and patient acceptance to participation and randomisation. Salient information relating to protocol implementation will be collated and study material such as the case report form will be tested. A range of candidate outcome measures will be examined for suitability in a larger RCT. Ethical approval was obtained from an NHS Research Ethics Committee. Findings will be published open access in a peer-reviewed journal, and presented at relevant conferences and research meetings. ISRCTN40215425; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Uncertainty about effects is a key factor influencing institutional review boards' approval of clinical studies.

PubMed

Wao, Hesborn; Mhaskar, Rahul; Kumar, Ambuj; Miladinovic, Branko; Guterbock, Thomas; Hozo, Iztok; Djulbegovic, Benjamin

2014-10-01

To investigate factors, which influence institutional review boards' (IRBs') decision to approve or not approve clinical studies, a nationwide vignette-based online survey of IRB members was conducted. A factorial design was used, whereby seven aspects of each hypothetical study were randomly varied in 15 phrases in each vignette to produce unique vignettes. Participants indicated the degree of study approval and described factors influencing approval decision. Qualitative responses were thematically content analyzed. Sixteen themes were obtained from 208 participants from 42 institutions. Uncertainty, adherence, study design, and harms were frequently and intensely cited to influence study approval. Analysis of two extreme subgroups (approvers vs. nonapprovers) showed that uncertainty influenced approval decisions, odds ratios (OR) = 3.5 (95% confidence interval [CI], 1.3-9.8) and OR = 3.2 (95% CI, 1.1-8.9), respectively, based on theme frequency and theme intensity, ignoring multiple observations per person. Taking into consideration multiple observations per person, similar results were obtained for uncertainty: OR = 8.9 (95% CI, 0.93-85.4). Perceived uncertainty about benefits and harms of a proposed intervention is a key driver in IRB members' approval of clinical trials. This, in turn, calls for improved standardization in the communications of information on benefits and harms in the research protocols considered by the IRBs. Published by Elsevier Inc.

Fast-track surgery for uncomplicated appendicitis in children: a matched case-control study.

PubMed

Cundy, Thomas P; Sierakowski, Kyra; Manna, Alexandra; Cooper, Celia M; Burgoyne, Laura L; Khurana, Sanjeev

2017-04-01

Standardized post-operative protocols reduce variation and enhance efficiency in patient care. Patients may benefit from these initiatives by improved quality of care. This matched case-control study investigates the effect of a multidisciplinary criteria-led discharge protocol for uncomplicated appendicitis in children. Key protocol components included limiting post-operative antibiotics to two intravenous doses, avoidance of intravenous opioid analgesia, prompt resumption of diet, active encouragement of early ambulation and nursing staff autonomy to discharge patients that met assigned criteria. The study period was from August 2015 to February 2016. Outcomes were compared with a historical control group matched for operative approach. Outcomes for 83 patients enrolled to our protocol were compared with those of 83 controls. There was a 29.2% reduction in median post-operative length of stay in our protocol-based care group (19.6 versus 27.7 h; P < 0.001). The rate of discharges within 24 h improved from 12 to 42%. There was no significant difference in complication rate (4.8 versus 7.2%; P = 0.51). Mean oral morphine dose equivalent per kilogram requirement was less than half (46%) that of control group patients (P < 0.001). Mean number of ondansetron doses was also significantly lower. Projected annual direct cost savings following protocol implementation was AUD$77 057. Implementation of a criteria-led discharge protocol at our hospital decreased length of stay, reduced variation in care, preserved existing low morbidity, incurred substantial cost savings, and safely rationalized opioid and antiemetic medication. These protocols are inexpensive and offer tangible benefits that are accessible to all health care settings. © 2016 Royal Australasian College of Surgeons.

Honest broker protocol streamlines research access to data while safeguarding patient privacy.

PubMed

Silvey, Scott A; Silvey, Scott Andrew; Schulte, Janet; Smaltz, Detlev H; Smaltz, Detlev Herb; Kamal, Jyoti

2008-11-06

At Ohio State University Medical Center, The Honest Broker Protocol provides a streamlined mechanism whereby investigators can obtain de-identified clinical data for non-FDA research without having to invest the significant time and effort necessary to craft a formalized protocol for IRB approval.

40 CFR 721.4472 - Phenyl, alkyl, hydroxyalkyl substituted imidazole (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... percent), and (c). (ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c... protocol. (3) TSCA Good Laboratory Practice Standards at 40 CFR part 792. (4) Using methodologies generally..., the person must obtain approval of test protocols from EPA by submitting written protocols. EPA will...

Education Against Tobacco (EAT): a quasi-experimental prospective evaluation of a programme for preventing smoking in secondary schools delivered by medical students: a study protocol.

PubMed

Brinker, Titus J; Stamm-Balderjahn, Sabine; Seeger, Werner; Groneberg, David A

2014-07-24

A survey conducted by the German Federal Centre for Health Education in 2012 showed that 35.2% of all young adults (18-25 years) and 12.0% of all adolescents (12-17 years) in Germany are regular cigarette smokers. Most smoked their first cigarette in early adolescence. We recently reported a significantly positive short-term effect of a physician-delivered school-based smoking prevention programme on the smoking behaviour of schoolchildren in Germany. However, physician-based programmes are usually very expensive. Therefore, we will evaluate and optimise Education against Tobacco (EAT), a widespread, low-cost programme delivered by about 400 medical students from 16 universities in Germany. A prospective quasi-experimental study design with two measurements at baseline (t1) and 6 months post-intervention (t2) to investigate an intervention in 10-15-year-olds in grades 6-8 at German secondary schools. The intervention programme consists of two 60-min school-based medical-student-delivered modules with (module 1) and without the involvement of patients with tobacco-related diseases and control groups (no intervention). The study questionnaire measuring smoking status (water pipe and cigarette smoking), smoking-related cognitions, and gender, social and cultural aspects was designed and pre-tested in advance. The primary end point is the prevalence of smokers and non-smokers in the two study arms at 6 months after the intervention. The percentage of former smokers and new smokers in the two groups and the measures of smoking behaviour will be studied as secondary outcome measures. In accordance with Good Epidemiologic Practice (GEP) guidelines, the study protocol was submitted for approval by the responsible ethics committee, which decided that the study does not need ethical approval (Goethe University, Frankfurt-Main, Germany). Findings will be disseminated in peer-reviewed journals, at conferences, within our scientific advisory board and through medical students within the EAT project. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Education Against Tobacco (EAT): a quasi-experimental prospective evaluation of a programme for preventing smoking in secondary schools delivered by medical students: a study protocol

PubMed Central

Brinker, Titus J; Stamm-Balderjahn, Sabine; Seeger, Werner; Groneberg, David A

2014-01-01

Introduction A survey conducted by the German Federal Centre for Health Education in 2012 showed that 35.2% of all young adults (18–25 years) and 12.0% of all adolescents (12–17 years) in Germany are regular cigarette smokers. Most smoked their first cigarette in early adolescence. We recently reported a significantly positive short-term effect of a physician-delivered school-based smoking prevention programme on the smoking behaviour of schoolchildren in Germany. However, physician-based programmes are usually very expensive. Therefore, we will evaluate and optimise Education against Tobacco (EAT), a widespread, low-cost programme delivered by about 400 medical students from 16 universities in Germany. Methods and analysis A prospective quasi-experimental study design with two measurements at baseline (t1) and 6 months post-intervention (t2) to investigate an intervention in 10–15-year-olds in grades 6–8 at German secondary schools. The intervention programme consists of two 60-min school-based medical-student-delivered modules with (module 1) and without the involvement of patients with tobacco-related diseases and control groups (no intervention). The study questionnaire measuring smoking status (water pipe and cigarette smoking), smoking-related cognitions, and gender, social and cultural aspects was designed and pre-tested in advance. The primary end point is the prevalence of smokers and non-smokers in the two study arms at 6 months after the intervention. The percentage of former smokers and new smokers in the two groups and the measures of smoking behaviour will be studied as secondary outcome measures. Ethics and dissemination In accordance with Good Epidemiologic Practice (GEP) guidelines, the study protocol was submitted for approval by the responsible ethics committee, which decided that the study does not need ethical approval (Goethe University, Frankfurt-Main, Germany). Findings will be disseminated in peer-reviewed journals, at conferences, within our scientific advisory board and through medical students within the EAT project. PMID:25059969

Knowledge, attitudes, beliefs and behaviour intentions for three bowel management practices in intensive care: effects of a targeted protocol implementation for nursing and medical staff.

PubMed

Knowles, Serena; Lam, Lawrence T; McInnes, Elizabeth; Elliott, Doug; Hardy, Jennifer; Middleton, Sandy

2015-01-01

Bowel management protocols have the potential to minimize complications for critically ill patients. Targeted implementation can increase the uptake of protocols by clinicians into practice. The theory of planned behaviour offers a framework in which to investigate clinicians' intention to perform the behaviour of interest. This study aimed to evaluate the effect of implementing a bowel management protocol on intensive care nursing and medical staffs' knowledge, attitude, subjective norms, perceived behavioural control, behaviour intentions, role perceptions and past behaviours in relation to three bowel management practices. A descriptive before and after survey using a self-administered questionnaire sent to nursing and medical staff working within three intensive care units before and after implementation of our bowel management protocol (pre: May - June 2008; post: Feb - May 2009). Participants had significantly higher knowledge scores post-implementation of our protocol (pre mean score 17.6; post mean score 19.3; p = 0.004). Post-implementation there was a significant increase in: self-reported past behaviour (pre mean score 5.38; post mean score 7.11; p = 0.002) and subjective norms scores (pre mean score 3.62; post mean score 4.18; p = 0.016) for bowel assessment; and behaviour intention (pre mean score 5.22; post mean score 5.65; p = 0.048) for administration of enema. This evaluation, informed by the theory of planned behaviour, has provided useful insights into factors that influence clinician intentions to perform evidence-based bowel management practices in intensive care. Addressing factors such as knowledge, attitudes and beliefs can assist in targeting implementation strategies to positively affect clinician behaviour change. Despite an increase in clinicians' knowledge scores, our implementation strategy did not, however, significantly change clinician behaviour intentions for all three bowel management practices. Further research is required to explore the influence of opinion leaders and organizational culture on clinicians' behaviour intentions related to bowel management for intensive care patients.

Acupuncture treatment for ischaemic stroke in young adults: protocol for a randomised, sham-controlled clinical trial

PubMed Central

Chen, Lifang; Fang, Jianqiao; Jin, Xiaoming; Keeler, Crystal Lynn; Gao, Hong; Fang, Zhen; Chen, Qin

2016-01-01

Introduction Stroke in young adults is not uncommon. Although the overall incidence of stroke has been recently declining, the incidence of stroke in young adults is increasing. Traditional vascular risk factors are the main cause of young ischaemic stroke. Acupuncture has been shown to benefit stroke rehabilitation and ameliorate the risk factors for stroke. The aims of this study were to determine whether acupuncture treatment will be effective in improving the activities of daily living (ADL), motor function and quality of life (QOL) in patients of young ischaemic stroke, and in preventing stroke recurrence by controlling blood pressure, lipids and body weight. Methods and analysis In this randomised, sham-controlled, participant-blinded and assessor-blinded clinical trial, 120 patients between 18 and 45 years of age with a recent (within 1 month) ischaemic stroke will be randomised for an 8-week acupuncture or sham acupuncture treatment. The primary outcome will be the Barthel Index for ADL. The secondary outcomes will include the Fugl-Meyer Assessment for motor function; the World Health Organization Quality of Life BREF (WHOQOL-BREF) for QOL; and risk factors that are measured by ambulatory blood pressure, the fasting serum lipid, body mass index and waist circumference. Incidence of adverse events and long-term mortality and recurrence rate during a 10-year and 30-year follow-up will also be investigated. Ethics and dissemination Ethics approval was obtained from the Ethics Committee of The Third Affiliated Hospital of Zhejiang Chinese Medical University. Protocol V.3 was approved in June 2013. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients by telephone during follow-up calls enquiring on the patient's post-study health status. Trial registration number ChiCTR-TRC- 13003317; Pre-results. PMID:26739742

Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies.

PubMed

Spelsberg, Angela; Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

2017-02-07

 To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act.  Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10.  Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany.  Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions.  Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals.  Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the sponsor. High remuneration and strict confidentiality clauses in these studies could influence the physicians' reporting behaviours of adverse drug reactions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

21 CFR 58.120 - Protocol.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., body weight range, sex, source of supply, species, strain, substrain, and age of the test system. (5... methods to be used. (b) All changes in or revisions of an approved protocol and the reasons therefore...

21 CFR 58.120 - Protocol.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., body weight range, sex, source of supply, species, strain, substrain, and age of the test system. (5... methods to be used. (b) All changes in or revisions of an approved protocol and the reasons therefore...

21 CFR 58.120 - Protocol.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., body weight range, sex, source of supply, species, strain, substrain, and age of the test system. (5... methods to be used. (b) All changes in or revisions of an approved protocol and the reasons therefore...

Nasal Irrigation for Chronic Rhinosinusitis and Fatigue in Patients with Gulf War Syndrome

DTIC Science & Technology

2013-07-01

materials (neti pots, xylitol , saline), and subject recruitment and enrollment. The human subjects research approval process required protocol submission...application submitted on 11/25/11 was also approved on 7/10/12. The company that provided xylitol (Danisco) is now owned by a private company (DuPont) a...regarding continuity of study as well as procurement and packaging of xylitol packets (sachets) for individual use by participants in the xylitol arm of

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

PubMed Central

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

2016-01-01

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

Assessment of neuromuscular function after different strength training protocols using tensiomyography.

PubMed

de Paula Simola, Rauno Á; Harms, Nico; Raeder, Christian; Kellmann, Michael; Meyer, Tim; Pfeiffer, Mark; Ferrauti, Alexander

2015-05-01

The purpose of the study was to analyze tensiomyography (TMG) sensitivity to changes in muscle force and neuromuscular function of the muscle rectus femoris (RF) using TMG muscle properties after 5 different lower-limb strength training protocols (multiple sets; DS = drop sets; eccentric overload; FW = flywheel; PL = plyometrics). After baseline measurements, 14 male strength trained athletes completed 1 squat training protocol per week over a 5-week period in a randomized controlled order. Maximal voluntary isometric contraction (MVIC), TMG measurements of maximal radial displacement of the muscle belly (Dm), contraction time between 10 and 90% of Dm (Tc), and mean muscle contraction velocities from the beginning until 10% (V10) and 90% of Dm (V90) were analyzed up to 0.5 (post-train), 24 (post-24), and 48 hours (post-48) after the training interventions. Significant analysis of variance main effects for measurement points were found for all TMG contractile properties and MVIC (p < 0.01). Dm and V10 post-train values were significantly lower after protocols DS and FW compared with protocol PL (p = 0.032 and 0.012, respectively). Dm, V10, and V90 decrements correlated significantly to the decreases in MVIC (r = 0.64-0.67, p ≤ 0.05). Some TMG muscle properties are sensitive to changes in muscle force, and different lower-limb strength training protocols lead to changes in neuromuscular function of RF. In addition, those protocols involving high and eccentric load and a high total time under tension may induce higher changes in TMG muscle properties.

The limits of evidence in drug approval and availability: a case study of cilostazol and naftidrofuryl for the treatment of intermittent claudication.

PubMed

Hong, Haeyeon; Mackey, William C

2014-08-01

Despite numerous efforts to develop effective medications for the treatment of intermittent claudication (IC) over the past 4 decades, a gold standard medical management option has yet to be defined. Although not life-threatening, IC interferes with mobility and activities of daily living, significantly impairing quality of life and potentially causing depression. Cilostazol, the leading pharmacologic agent for IC in the United States, was approved by the US Food and Drug Administration (FDA) in 1999 based on controversial data. Meanwhile, naftidrofuryl, the first-line pharmacologic agent for IC in the United Kingdom and Europe, has never been approved by the FDA and therefore is not available in the United States. The clinical data for cilostazol and naftidrofuryl are plagued by flaws related to lack of protocol standardization, objective endpoints, and strict eligibility criteria in study subjects, making identification of a true treatment effect impossible. Furthermore, no prospective randomized trial comparing the efficacy of cilostazol and naftidrofuryl has been conducted, because the manufacturers of these agents have much to lose and little to gain from such a study. This article provides an overview of the pharmacology of cilostazol and naftidrofuryl, and the clinical studies leading to their approval and clinical acceptance. It further explores the possible sources of bias in analyzing these clinical trials, some of which have been brought to light by the National Institute for Health and Clinical Excellence (NICE) of the United Kingdom in its technology appraisal guidance. It also speculates the ways in which economic incentives may affect drug-marketing decisions. A literature review of pharmacology and clinical trials for cilostazol and naftidrofuryl was performed in PubMed. The majority of included clinical trials were initially identified through the most recent Cochrane review articles as well as the FDA's approval packet for cilostazol. The technology appraisal guidance of the National Institute for Health and Care Excellence of the United Kingdom and the manufacturer's response to this guidance document were located via an online search engine. The clinical data for cilostazol and naftidrofuryl are plagued by flaws related to lack of protocol standardization, objective endpoints, and strict eligibility criteria in study subjects, making identification of a true treatment effect difficult. Furthermore, no prospective randomized trial comparing the efficacy of cilostazol and naftidrofuryl has been conducted. The history of the evaluation, approval, and marketing of these drugs illustrates the limitations of data in the regulatory approval and marketing of agents whose benefit is subjective and difficult to quantify. Implementation of a standardized protocol with strict eligibility criteria, objective quantifiable measurement of drug effect, and validated endpoints will eventually allow development of an ideal pharmacotherapy for IC. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

40 CFR 792.33 - Study director.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Study director. 792.33 Section 792.33 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED... protocol, including any change, is approved as provided by § 792.120 and is followed. (b) All experimental...

30 CFR 74.14 - Certificate of approval.

Code of Federal Regulations, 2013 CFR

2013-07-01

.... (a) Upon completion of the testing of a CMDPSU or the pump unit or after review of testing protocols... unless MSHA has first issued a certificate of approval for either the pump unit of a CMDPSU or for the... the CMDPSU and the pump unit, or of the CPDM, as appropriate, upon which the certificate of approval...

30 CFR 74.14 - Certificate of approval.

Code of Federal Regulations, 2012 CFR

2012-07-01

.... (a) Upon completion of the testing of a CMDPSU or the pump unit or after review of testing protocols... unless MSHA has first issued a certificate of approval for either the pump unit of a CMDPSU or for the... the CMDPSU and the pump unit, or of the CPDM, as appropriate, upon which the certificate of approval...

30 CFR 74.14 - Certificate of approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... (a) Upon completion of the testing of a CMDPSU or the pump unit or after review of testing protocols... unless MSHA has first issued a certificate of approval for either the pump unit of a CMDPSU or for the... the CMDPSU and the pump unit, or of the CPDM, as appropriate, upon which the certificate of approval...

30 CFR 74.14 - Certificate of approval.

Code of Federal Regulations, 2014 CFR

2014-07-01

.... (a) Upon completion of the testing of a CMDPSU or the pump unit or after review of testing protocols... unless MSHA has first issued a certificate of approval for either the pump unit of a CMDPSU or for the... the CMDPSU and the pump unit, or of the CPDM, as appropriate, upon which the certificate of approval...

30 CFR 74.14 - Certificate of approval.

Code of Federal Regulations, 2011 CFR

2011-07-01

.... (a) Upon completion of the testing of a CMDPSU or the pump unit or after review of testing protocols... unless MSHA has first issued a certificate of approval for either the pump unit of a CMDPSU or for the... the CMDPSU and the pump unit, or of the CPDM, as appropriate, upon which the certificate of approval...

40 CFR 141.709 - Developing the disinfection profile and benchmark.

Code of Federal Regulations, 2010 CFR

2010-07-01

... flow or at an alternative location approved by the State. (2) For systems using chlorine, the pH of the... peak hourly flow or at an alternative location approved by the State. (3) The disinfectant contact time... plant based on a protocol approved by the State. (b) Systems with a single point of disinfectant...

Metamaterial Resonant Absorbers for Terahertz Sensing

DTIC Science & Technology

2015-12-01

Equation Chapter 1 Section 1 NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA THESIS Approved for public release; distribution...Co-Advisor Fabio Alves THIS PAGE INTENTIONALLY LEFT BLANK i REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704–0188 Public reporting...Department of Defense or the U.S. government. IRB Protocol number ____N/A____. 12a. DISTRIBUTION / AVAILABILITY STATEMENT Approved for public

High Power Quantum Cascade Laser for Terahertz Imaging

DTIC Science & Technology

2012-03-01

NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA THESIS Approved for public release, distribution is unlimited HIGH POWER QUANTUM...Second Reader: Fabio Alves THIS PAGE INTENTIONALLY LEFT BLANK i REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704-0188 Public reporting...Department of Defense or the U.S. Government. IRB Protocol Number: N/A 12a. DISTRIBUTION / AVAILABILITY STATEMENT Approved for public release

77 FR 5492 - Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Application for...

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Adherence to, and outcomes of, a galactomannan screening protocol in high-risk hematology patients.

PubMed

Harricharan, S; Biederman, K; Bombassaro, A M; Lazo-Langner, A; Elsayed, S; Fulford, A; Delport, J A; Xenocostas, A

2018-04-01

A twice-weekly galactomannan (gm) screening protocol was implemented in high-risk hematology inpatients. Study objectives were to determine adherence to the protocol, use of selected resources, and patient outcomes. This retrospective cohort study compared outcomes of interest before and after implementation of gm screening. Adults undergoing matched related allogeneic hematopoietic stem-cell transplantation or induction chemotherapy for acute leukemia were eligible. Patients could be enrolled more than once and were evaluated as episodes. Adherence to the gm protocol was assessed in post-implementation episodes. Use of broad-spectrum antifungals (bsafs), consultations (infectious diseases, respirology), and diagnostic procedures (computed tomography imaging, bronchoalveolar lavage) were compared between phases, as were the patient outcomes of all-cause mortality and clinical success (alive and not taking a bsaf). Of 182 episodes consecutively screened, 70 per phase were enrolled. Clinical characteristics and duration of assessment were similar for the phases. Full or partial adherence to the protocol was observed in 61 post-implementation episodes (87%), with full adherence in 40 episodes (57%). More episodes in the pre-implementation phase than in the post-implementation phase involved receipt of bsafs, consultations, and diagnostics (27% vs. 7%, p = 0.02; 46% vs. 26%, p = 0.014; and 46% vs. 31%, p = 0.083 respectively). Although mortality was similar in the two phases, clinical success at the final assessment was observed in fewer pre-implementation than post-implementation episodes (79% vs. 98%, p < 0.001). Implementation of a gm screening protocol was feasible and associated with significantly fewer episodes involving receipt of bsafs and consultations, and with significantly more episodes showing clinical success.

Latest trends in the assessment and management of paediatric snoring and sleep apnoea.

PubMed

Sharma, S D; Kanona, H; Kumar, G; Kotecha, B

2016-05-01

To investigate the assessment and management of paediatric snoring and obstructive sleep apnoea in UK otolaryngology departments. A telephone questionnaire survey of UK otolaryngology departments was conducted over a 16-week period. The response rate was 61 per cent (85 out of 139 trusts). Use of pre-operative pulse oximetry was reported by 84 per cent of respondents, mainly to diagnose obstructive sleep apnoea (73 per cent) or stratify post-operative risk (46 per cent). Thirty-one per cent of respondents reported using post-operative pulse oximetry. Twenty-five per cent of respondents have a dedicated management protocol for paediatric obstructive sleep apnoea and snoring. Thirty-four per cent require prior clinical commissioning group approval before performing surgery. Fifty-eight per cent of respondents reported following up their obstructive sleep apnoea patients after surgery. The mean follow-up period (±standard deviation) was 6.8 ± 1.2 weeks. There is variation in the assessment and management of paediatric snoring and obstructive sleep apnoea across the UK, particularly in the use of pre- and post-operative pulse oximetry monitoring, and further guidelines regarding this are necessary.

Multicenter Clinical Trial of Keratin Biomaterials for Peripheral Nerve Regeneration

DTIC Science & Technology

2013-10-01

As soon as the IND is available, our team will be able to obtain final approval for the study protocol from the Copernicus Group, an independent... Copernicus Group, an independent IRB located in Research Triangle Park, North Carolina. Due to the conflict of interest policies at the Wake Forest...School of Medicine, Dr. Li was asked to send the protocol to an independent review board.  October 13, 2010: The Copernicus Group granted conditional

Combination Protocol of Low-Frequency rTMS and Intensive Occupational Therapy for Post-stroke Upper Limb Hemiparesis: a 6-year Experience of More Than 1700 Japanese Patients.

PubMed

Kakuda, Wataru; Abo, Masahiro; Sasanuma, Jinichi; Shimizu, Masato; Okamoto, Takatsugu; Kimura, Chikou; Kakita, Kiyohito; Hara, Hiroyoshi

2016-06-01

Several years ago, we proposed a combination protocol of repetitive transcranial magnetic stimulation (rTMS) and intensive occupational therapy (OT) for upper limb hemiparesis after stroke. Subsequently, the number of patients treated with the protocol has increased in Japan. We aimed to present the latest data on our proposed combination protocol for post-stroke upper limb hemiparesis as a result of a multi-institutional study. After confirming that a patient met the inclusion criteria for the protocol, they were scheduled to receive the 15-day inpatient protocol. In the protocol, two sessions of 20-min rTMS and 120-min occupational therapy were provided daily, except for Sundays and the days of admission/discharge. Motor function of the affected upper limb was evaluated by the Fugl-Meyer assessment (FMA) and Wolf motor function test (WMFT) at admission/discharge and at 4 weeks after discharge if possible. A total of 1725 post-stroke patients were studied (mean age at admission 61.4 ± 13.0 years). The scheduled 15-day protocol was completed by all patients. At discharge, the increase in FMA score, shortening in performance time of WMFT, and increase in functional ability scale (FAS) score of WMFT were significant (FMA score 46.8 ± 12.2 to 50.9 ± 11.4 points, p < 0.001; performance time of WMFT 2.57 ± 1.32 to 2.21 ± 1.33, p < 0.001; FAS score of WMFT 47.4 ± 14. to 51.4 ± 14.3 points, p < 0.001). Our proposed combination protocol can be a potentially safe and useful therapeutic intervention for upper limb hemiparesis after stroke, although its efficacy should be confirmed in a randomized controlled study.

Ethics approval: responsibilities of journal editors, authors and research ethics committees.

PubMed

Bain, Luchuo Engelbert

2017-01-01

Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply unaware of its importance. Good research involves risks taken by research participants and uses tax payers' money in the process. These mandates the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science. Most researchers mistake scientific clearance or approval, for ethics approval. For a study to be ethical sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. It is not uncommon for sensitive ethical concerns, especially in the social sciences to be overlooked and considered not to be accompanied by any serious risks for the research participants.The researcher has the responsibility of systematically consulting the competent ethics committee for advice and consequent approvals or ethical waivers. Journal editors and reviewers have the duty to systematically evaluate the ethical soundness of manuscripts submitted for review. Capacity building in research ethics and institutional support for Research Ethics Committees to speed up protocol review could reduce the incentive of carrying out research in human subjects without ethics approvals. It is hypocritical and idle to continue to expect optimal reviews on time and of good quality, from ethics committees functioning purely on altruistic grounds. Capacity building for researchers in research ethics, and institutional reforms and support for Research Ethics Committees appear not to have received the attention they truly deserve.

40 CFR 792.35 - Quality assurance unit.

Code of Federal Regulations, 2010 CFR

2010-07-01

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40 CFR 792.35 - Quality assurance unit.

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2011-07-01

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40 CFR 792.35 - Quality assurance unit.

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2014-07-01

... from approved protocols or standard operating procedures were made without proper authorization and... standard operating procedures, and that the reported results accurately reflect the raw data of the study... ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Organization and Personnel § 792.35 Quality...

40 CFR 792.35 - Quality assurance unit.

Code of Federal Regulations, 2013 CFR

2013-07-01

... from approved protocols or standard operating procedures were made without proper authorization and... standard operating procedures, and that the reported results accurately reflect the raw data of the study... ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Organization and Personnel § 792.35 Quality...

Effectiveness of trauma-focused psychological therapies compared to usual postnatal care for treating post-traumatic stress symptoms in women following traumatic birth: a systematic review protocol.

PubMed

Furuta, Marie; Spain, Debbie; Bick, Debra; Ng, Edmond S W; Sin, Jacqueline

2016-11-24

Maternal mental health has been largely neglected in the literature. Women, however, may be vulnerable to developing post-traumatic stress symptoms or post-traumatic stress disorder (PTSD), following traumatic birth. In turn, this may affect their capacity for child rearing and ability to form a secure bond with their baby and impact on the wider family. Trauma-focused psychological therapies (TFPT) are widely regarded as effective and acceptable interventions for PTSD in general and clinical populations. Relatively little is known about the effectiveness of TFPT for women postpartum who have post-traumatic stress symptoms. We will conduct a review to assess the effectiveness of TFPT, compared with usual postpartum care, as a treatment for post-traumatic stress symptoms or PTSD for women following traumatic birth. Using a priori search criteria, we will search for randomised controlled trials (RCT) in four databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PsycINFO and OpenGrey. We will use search terms that relate to the population, TFPT and comparators. Screening of search results and data extraction will be undertaken by two reviewers, independently. Risk of bias will be assessed in RCTs which meet the review criteria. Data will be analysed using the following methods, as appropriate: narrative synthesis; meta-analysis; subgroup analysis and meta-regression. As this work comprises a synthesis of existing studies, ethical approvals are not required. Results will be disseminated at conferences and in publications. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Time required to initiate outbreak and pandemic observational research.

PubMed

Rishu, Asgar H; Marinoff, Nicole; Julien, Lisa; Dumitrascu, Mariana; Marten, Nicole; Eggertson, Shauna; Willems, Su; Ruddell, Stacy; Lane, Dan; Light, Bruce; Stelfox, Henry T; Jouvet, Philippe; Hall, Richard; Reynolds, Steven; Daneman, Nick; Fowler, Robert A

2017-08-01

Observational research focused upon emerging infectious diseases such as Ebola virus, Middle East respiratory syndrome, and Zika virus has been challenging to quickly initiate. We aimed to determine the duration of start-up procedures and barriers encountered for an observational study focused upon such infectious outbreaks. At 1 pediatric and 5 adult intensive care units, we measured durations from protocol receipt to a variety of outbreak research milestones, including research ethics board (REB) approval, data sharing agreement (DSA) execution, and patient study screening initiation. The median (interquartile range) time from site receipt of the protocol to REB submission was 73 (30-126) days; to REB approval, 158 (42-188) days; to DSA completion, 276 (186-312) days; and to study screening initiation, 293 (269-391) days. The median time from REB submission to REB approval was 43 (13-85) days. The median time for all start-up procedures was 335 (188-335) days. There is a lengthy start-up period required for outbreak-focused research. Completing DSAs was the most time-consuming step. A reactive approach to newly emerging threats such as Ebola virus, Middle East respiratory syndrome, and Zika virus will likely not allow sufficient time to initiate research before most outbreaks are advanced. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Beyond repair - family and community reintegration after obstetric fistula surgery: study protocol.

PubMed

Byamugisha, Josaphat; El Ayadi, Alison; Obore, Susan; Mwanje, Haruna; Kakaire, Othman; Barageine, Justus; Lester, Felicia; Butrick, Elizabeth; Korn, Abner; Nalubwama, Hadija; Knight, Sharon; Miller, Suellen

2015-12-18

Obstetric fistula is a debilitating birth injury that affects an estimated 2-3 million women globally, most in sub-Saharan Africa and Asia. The urinary and/or fecal incontinence associated with fistula affects women physically, psychologically and socioeconomically. Surgical management of fistula is available with clinical success rates ranging from 65-95 %. Previous research on fistula repair outcomes has focused primarily on clinical outcomes without considering the broader goal of successful reintegration into family and community. The objectives for this study are to understand the process of family and community reintegration post fistula surgery and develop a measurement tool to assess long-term success of post-surgical family and community reintegration. This study is an exploratory sequential mixed-methods design including a preliminary qualitative component comprising in-depth interviews and focus group discussions to explore reintegration to family and community after fistula surgery. These results will be used to develop a reintegration tool, and the tool will be validated within a small longitudinal cohort (n = 60) that will follow women for 12 months after obstetric fistula surgery. Medical record abstraction will be conducted for patients managed within the fistula unit. Ethical approval for the study has been granted. This study will provide information regarding the success of family and community reintegration among women returning home after obstetric fistula surgery. The clinical and research community can utilize the standardized measurement tool in future studies of this patient population.

Does modifying the timing of meal intake improve cardiovascular risk factors? Protocol of an Australian pilot intervention in night shift workers with abdominal obesity.

PubMed

Bonham, Maxine P; Leung, Gloria K W; Davis, Rochelle; Sletten, Tracey L; Murgia, Chiara; Young, Morag J; Eikelis, Nina; Lambert, Elisabeth A; Huggins, Catherine E

2018-03-14

Shift work is an independent risk factor for cardiovascular disease (CVD). Shift workers who are awake overnight and sleep during the day are misaligned with their body's endogenous circadian rhythm. Eating at night contributes to this increased risk of CVD by forcing the body to actively break down and process nutrients at night. This pilot study aims to determine whether altering meal timing overnight, in a shift working population, will impact favourably on modifiable risk factors for CVD (postprandial bplasma lipids and glucose concentration). A randomised cross-over study with two 4-week test periods, separated by a minimum of a 2-week washout will be undertaken. The effectiveness of redistributing energy intake overnight versus ad libitum eating patterns on CVD risk factors will be examined in night shift workers (n=20), using a standard acute test meal challenge protocol. Primary outcomes (postprandial lipids and glucose) will be compared between the two conditions: post-intervention and post-control period using analysis of variance. Potential effect size estimates to inform sample size calculations for a main trial will also be generated. Ethics approval has been granted by the Monash University Human Research Ethics Committee (2017-8619-10329). Outcomes from this study will determine whether eliminating food intake for a defined period at night (1-6 am) impacts favourably on metabolic risk factors for CVD in night shift workers. Collective results from this novel trial will be disseminated through peer-reviewed journals, and national and international presentations. The results are essential to inform health promotion policies and guidelines for shift workers, especially those who aim to improve their metabolic health. ACTRN12617000791336; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Effectiveness of a multiple-strategy community intervention to reduce maternal and child health inequalities in Haryana, North India: a mixed-methods study protocol.

PubMed

Gupta, Madhu; Angeli, Federica; van Schayck, Onno C P; Bosma, Hans

2015-01-01

A multiple-strategy community intervention, known as National Rural Health Mission (NRHM), launched in India to improve the availability of and access to better-quality healthcare, especially for rural, poor mothers and children. The final goal of the intervention is to reduce maternal and child health inequalities across geographical areas, socioeconomic status groups, and sex of the child. Extensive, in-depth research is necessary to assess the effectiveness of NRHM, on multiple outcome dimensions. This paper presents the design of a new study, able to overcome the shortcomings of previous research. To propose a comprehensive, methodologically sound protocol to assess the extent of implementation and the effectiveness of NRHM measures to improve maternal and child health outcomes and reduce maternal and child health inequalities. A mixed-methods approach (quantitative and qualitative) is proposed for this study in Haryana, a state in North India. NRHM's health sector plans included health system strengthening, specific maternal and child healthcare strategies, and communitization. Mission documents and reports on progress, financial monitoring, and common and joint review will be reviewed in-depth to assess the extent of the implementation of plans. Data on maternal and child health indicators will be obtained from demographic health surveys held before, during, and after the implementation of the first phase of the NRHM (2005-2012) and compared over time. Differences in maternal and child health indicators will be used to measure maternal and child health inequalities; these will be compared pre- and post-NRHM. Focus group discussions (FGDs) with service providers and in-depth interviews with program managers, community representatives, and mothers will be conducted until data saturation is achieved, in two districts of Haryana. Using Nvivo software, an inductive qualitative content analysis will be performed to search for the broader themes across the interviews and FGDs. Ethical approval was obtained from the Ethics Committee of the Post Graduate Institute of Medical Education and Research.

Use of a mobile social networking intervention for weight management: a mixed-methods study protocol.

PubMed

Laranjo, Liliana; Lau, Annie Y S; Martin, Paige; Tong, Huong Ly; Coiera, Enrico

2017-07-12

Obesity and physical inactivity are major societal challenges and significant contributors to the global burden of disease and healthcare costs. Information and communication technologies are increasingly being used in interventions to promote behaviour change in diet and physical activity. In particular, social networking platforms seem promising for the delivery of weight control interventions.We intend to pilot test an intervention involving the use of a social networking mobile application and tracking devices ( Fitbit Flex 2 and Fitbit Aria scale) to promote the social comparison of weight and physical activity, in order to evaluate whether mechanisms of social influence lead to changes in those outcomes over the course of the study. Mixed-methods study involving semi-structured interviews and a pre-post quasi-experimental pilot with one arm, where healthy participants in different body mass index (BMI) categories, aged between 19 and 35 years old, will be subjected to a social networking intervention over a 6-month period. The primary outcome is the average difference in weight before and after the intervention. Secondary outcomes include BMI, number of steps per day, engagement with the intervention, social support and system usability. Semi-structured interviews will assess participants' expectations and perceptions regarding the intervention. Ethics approval was granted by Macquarie University's Human Research Ethics Committee for Medical Sciences on 3 November 2016 (ethics reference number 5201600716).The social network will be moderated by a researcher with clinical expertise, who will monitor and respond to concerns raised by participants. Monitoring will involve daily observation of measures collected by the fitness tracker and the wireless scale, as well as continuous supervision of forum interactions and posts. Additionally, a protocol is in place to monitor for participant misbehaviour and direct participants-in-need to appropriate sources of help. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Use of a mobile social networking intervention for weight management: a mixed-methods study protocol

PubMed Central

Lau, Annie Y S; Martin, Paige; Tong, Huong Ly; Coiera, Enrico

2017-01-01

Introduction Obesity and physical inactivity are major societal challenges and significant contributors to the global burden of disease and healthcare costs. Information and communication technologies are increasingly being used in interventions to promote behaviour change in diet and physical activity. In particular, social networking platforms seem promising for the delivery of weight control interventions. We intend to pilot test an intervention involving the use of a social networking mobile application and tracking devices (Fitbit Flex 2 and Fitbit Aria scale) to promote the social comparison of weight and physical activity, in order to evaluate whether mechanisms of social influence lead to changes in those outcomes over the course of the study. Methods and analysis Mixed-methods study involving semi-structured interviews and a pre–post quasi-experimental pilot with one arm, where healthy participants in different body mass index (BMI) categories, aged between 19 and 35 years old, will be subjected to a social networking intervention over a 6-month period. The primary outcome is the average difference in weight before and after the intervention. Secondary outcomes include BMI, number of steps per day, engagement with the intervention, social support and system usability. Semi-structured interviews will assess participants’ expectations and perceptions regarding the intervention. Ethics and dissemination Ethics approval was granted by Macquarie University’s Human Research Ethics Committee for Medical Sciences on 3 November 2016 (ethics reference number 5201600716). The social network will be moderated by a researcher with clinical expertise, who will monitor and respond to concerns raised by participants. Monitoring will involve daily observation of measures collected by the fitness tracker and the wireless scale, as well as continuous supervision of forum interactions and posts. Additionally, a protocol is in place to monitor for participant misbehaviour and direct participants-in-need to appropriate sources of help. PMID:28706104

48 CFR 1352.235-71 - Protection of human subjects-exemption.

Code of Federal Regulations, 2014 CFR

2014-10-01

... a systematic investigation, including research development, testing and evaluation, designed to...; (2) Documentation of approval for the human subjects research protocol, questionnaires, surveys... contractor modifies a human subjects research protocol, questionnaire, survey, advertisement, or informed...

48 CFR 1352.235-71 - Protection of human subjects-exemption.

Code of Federal Regulations, 2010 CFR

2010-10-01

... a systematic investigation, including research development, testing and evaluation, designed to...; (2) Documentation of approval for the human subjects research protocol, questionnaires, surveys... contractor modifies a human subjects research protocol, questionnaire, survey, advertisement, or informed...

48 CFR 1352.235-71 - Protection of human subjects-exemption.

Code of Federal Regulations, 2013 CFR

2013-10-01

... a systematic investigation, including research development, testing and evaluation, designed to...; (2) Documentation of approval for the human subjects research protocol, questionnaires, surveys... contractor modifies a human subjects research protocol, questionnaire, survey, advertisement, or informed...

48 CFR 1352.235-71 - Protection of human subjects-exemption.

Code of Federal Regulations, 2011 CFR

2011-10-01

... a systematic investigation, including research development, testing and evaluation, designed to...; (2) Documentation of approval for the human subjects research protocol, questionnaires, surveys... contractor modifies a human subjects research protocol, questionnaire, survey, advertisement, or informed...

48 CFR 1352.235-71 - Protection of human subjects-exemption.

Code of Federal Regulations, 2012 CFR

2012-10-01

... a systematic investigation, including research development, testing and evaluation, designed to...; (2) Documentation of approval for the human subjects research protocol, questionnaires, surveys... contractor modifies a human subjects research protocol, questionnaire, survey, advertisement, or informed...

Lower Body Negative Pressure Treadmill Exercise and Resistive Exercise Countermeasures Maintain Physiologic Function in Women during Simulated Microgravity

NASA Technical Reports Server (NTRS)

Macias, B. R.; Schneider, S. M.; Lee, S. M. C.; Guinet, P.; Hughson, R. L.; Smith, Scott M.; Watenpaugh, D. E.; Hargens, A. R.

2008-01-01

We hypothesized that supine LBNP treadmill exercise combined with Flywheel resistive exercise maintains upright physiologic responses following 60-days of head-down tilt (HDT) bed rest (BR). METHODS: 16 healthy women (age 25-40 years) underwent 60-days HDT (-6deg.) BR. Women were assigned to either a non-exercise control group (CON, n=8) or to an exercise group (EX, n=8). EX subjects performed a 40-min, variable intensity LBNP exercise protocol at foot-ward forces between 1.0-1.1 times body weight, followed by 10- min of resting LBNP 3-4 days/week. Resistive exercise of maximal concentric and eccentric supine leg press and heel raise exercises were performed using a flywheel ergometer 2-3 days/week. IRBs approved this study with informed/written consent. RESULTS: Post-BR VO2pk was not different in EX (-3.3+/-1.2%) but decreased significantly in CON (-21.2+/-2.1%), p< 0.05. Post-BR orthostatic tolerance time (mean se) decreased significantly less in EX (19.3+/-1.3 to 14.4+/-1.5 min) than in CON (17.5+/-0.1 to 9.1+/- 1.5 min), p=0.03. Post-BR muscle strength decreased significantly in CON, but was preserved in EX. Post-BR bone resorption was greater than pre-BR in both groups (p<0.05). Bone formation markers, were significantly elevated (p<0.05) in EX than in CON. CONCLUSIONS: Supine LBNP treadmill exercise along with flywheel resistive exercise maintains upright exercise capacity, orthostatic responses and muscle strength during 60-days HDT BR.

The effects of prenatal cannabis exposure on fetal development and pregnancy outcomes: a protocol.

PubMed

Gunn, Jayleen K L; Rosales, Cecilia B; Center, Katherine E; Nuñez, Annabelle V; Gibson, Steven J; Ehiri, John E

2015-03-13

The effects of exposure to marijuana in utero on fetal development are not clear. Given that the recent legislation on cannabis in the US is likely to result in increased use, there is a need to assess the effects of prenatal cannabis exposure on fetal development and pregnancy outcomes. The objective of this review is to assess the effects of prenatal exposure to cannabis on pregnancy outcomes (including maternal and child outcomes). Major databases will be searched from inception to the latest issue, with the aim of identifying studies that reported the effects of prenatal exposure to cannabis on fetal development and pregnancy outcomes. Two investigators will independently review all titles and abstracts to identify potential articles. Discrepancies will be resolved by repeated review, discussion and consensus. Study quality assessment will be undertaken, using standard protocols. To qualify for inclusion, studies must report at least one maternal or neonatal outcome post partum. Cross-sectional, case-control, cohort and randomised controlled trials published in English will be included. In order to rule out the effects of other drugs that may affect fetal development and pregnancy outcomes, studies will only be included if they report outcomes of prenatal exposure to cannabis while excluding other illicit substances. Data from eligible studies will be extracted, and data analysis will include a systematic review and critical appraisal of evidence, and meta-analysis if data permit. Meta-analysis will be conducted if three or more studies report comparable statistics on the same outcome. The review which will result from this protocol has not already been conducted. Preparation of the review will follow the procedures stated in this protocol, and will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Ethical approval of data will not be required since the review will use data that are already available in the public domain through published articles and other reports. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A Comparison between Chocolate Milk and a Raw Milk Honey Solution’s Influence on Delayed Onset of Muscle Soreness

PubMed Central

Hatchett, Andrew; Berry, Christopher; Oliva, Claudia; Wiley, Douglas; St. Hilaire, Jacob; LaRochelle, Alex

2016-01-01

This investigation sought to examine the effect that a chocolate milk solution (CMS) and a raw milk solution (RMS) had on lower extremity induced delayed onset of muscle soreness (DOMS). Twenty trained male participants completed a set of questionnaires, prior to completing a lower extremity DOMS protocol, to determine the level of discomfort and functional limitations. Once the DOMS protocol was completed, participants were randomly assigned to either the CM or RM group. Once assigned, participants ingested 240 mL of the respective solution and completed the same set of questionnaires immediately post, 24-, 48- and 72-h post DOMS protocol. Additionally, for 10 days post-ingestion participants were contacted to learn if any negative effects were experienced as a result of ingesting either solution. Both groups reported an increase in lower extremity discomfort at each data collection interval post-DOMS protocol (post, 24-, 48- and 72-h). Participants assigned to the RM group reported high discomfort post and a relative decline in discomfort from immediately post-DOMS protocol to 72-h post. The RMS group reported substantially less discomfort at 72-h when compared to the CMS group. Ingestion of a raw milk solution immediately post strength exercise can substantially reduce the level of self-reported discomfort associated with DOMS. PMID:29910267

Evaluation of a Low-risk Mild Traumatic Brain Injury and Intracranial Hemorrhage Emergency Department Observation Protocol.

PubMed

Yun, Brian J; Borczuk, Pierre; Wang, Lulu; Dorner, Stephen; White, Benjamin A; Raja, Ali S

2017-11-20

Among emergency physicians, there is wide variation in admitting practices for patients who suffered a mild traumatic brain injury (TBI) with an intracranial hemorrhage (ICH). The purpose of this study was to evaluate the effects of implementing a protocol in the emergency department (ED) observation unit for patients with mild TBI and ICH. This retrospective cohort study was approved by the institutional review board. Study subjects were patients ≥ 18 years of age with an International Classification of Diseases code corresponding to a traumatic ICH and admitted to an ED observation unit (EDOU) of an urban, academic Level I trauma center between February 1, 2015, and January 31, 2017. Patient data and discharge disposition were abstracted from the electronic health record, and imaging data, from the final neuroradiologist report. To measure kappa, two abstractors independently collected data for presence of neuro deficit from a 10% random sample of the medical charts. Using a multivariable logistic regression model with a propensity score of the probability of placement in the EDOU before and after protocol implementation as a covariate, we sought to determine the pre-post effects of implementing a protocol on the composite outcome of admission to the floor, intensive care unit, or operating room from the EDOU and the proportion of patients with worsening findings on repeat computed tomography (CT) head scan in the EDOU. A total of 379 patients were identified during the study period; 83 were excluded as they were found to have no ICH on chart review. Inter-rater reliability kappa statistic was 0.63 for 30 charts. Among the 296 patients who remained eligible and comprised the study population, 143 were in the preprotocol period and 153 after protocol implementation. The EDOU protocol was associated with an independently statistically significant decreased odds ratio (OR) for admission or worsening ICH on repeat CT scan (OR = 0.45, 95% confidence interval [CI] = 0.25-0.82, p = 0.009) in the observation unit. After a stay in the EDOU, 26% (37/143) of patients required an inpatient admission before implementation of the protocol and 13% (20/153) of patients required an inpatient admission after protocol implementation. There was no statistically significant difference in log transformed EDOU length of stay (LOS) between the groups after adjusting for propensity score (p = 0.34). While there was no difference in EDOU LOS, implementing a low-risk mild TBI and ICH protocol in the EDOU may decrease the rate of inpatient admissions from the EDOU. A protocol-driven observation unit may help physicians by standardizing eligibility criteria and by providing guidance on management. As the propensity score method limits our ability to create a straightforward predictive model, a future larger study should validate the results. © 2017 by the Society for Academic Emergency Medicine.

Reducing the Time for IRB Reviews: A Case Study

ERIC Educational Resources Information Center

Liberale, Andrea Pescina; Kovach, Jamison V.

2017-01-01

Research activities often involve enrolling human subjects as volunteers to participate in research studies. Federal regulations mandate that research institutions are responsible for protecting the ethical rights and welfare of human subjects from research risks. This is usually accomplished by requiring approval of research protocols by an…

An integrated intervention to reduce intimate partner violence and psychological distress with refugees in low-resource settings: study protocol for the Nguvu cluster randomized trial.

PubMed

Tol, Wietse A; Greene, M Claire; Likindikoki, Samuel; Misinzo, Lusia; Ventevogel, Peter; Bonz, Ann G; Bass, Judith K; Mbwambo, Jessie K K

2017-05-18

Intimate partner violence (IPV) is a critical public health and human rights concern globally, including for refugee women in low-resource settings. Little is known about effective interventions for this population. IPV and psychological distress have a bi-directional relationship, indicating the potential benefit of a structured psychological component as part of efforts to reduce IPV for women currently in violent relationships. This protocol describes a cluster randomized controlled trial aimed at evaluating an 8-session integrated psychological and advocacy intervention (Nguvu) with female adult survivors of past-year IPV displaying moderate to severe psychological distress. Outcomes are reductions in: recurrence of IPV; symptoms of anxiety, depression and post-traumatic stress (primary); and functional impairment (secondary). Hypothesized mediators of the intervention are improvements in social support, coping skills and support seeking. We will recruit 400 participants from existing women's support groups operating within villages in Nyarugusu refugee camp, Tanzania. Women's groups will be randomized to receive the intervention (Nguvu and usual care) or usual care alone. All eligible women will complete a baseline assessment (week 0) followed by a post-treatment (week 9) and a 3-month post-treatment assessment (week 20). The efficacy of the intervention will be determined by between-group differences in the longitudinal trajectories of primary outcomes evaluated using mixed-effects models. Study procedures have been approved by Institutional Review Boards in the United States and Tanzania. This trial will provide evidence on the efficacy of a novel integrated group intervention aimed at secondary prevention of IPV that includes a structured psychological component to address psychological distress. The psychological and advocacy components of the proposed intervention have been shown to be efficacious for their respective outcomes when delivered in isolation; however, administering these approaches through a single, integrated intervention may result in synergistic effects given the interrelated, bidirectional relationship between IPV and mental health. Furthermore, this trial will provide information regarding the feasibility of implementing a structured intervention for IPV and mental health in a protracted humanitarian setting. ISRCTN65771265 , June 27, 2016.

Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery

PubMed Central

Warner, Matthew A; Welsby, Ian J; Norris, Phillip J; Silliman, Christopher C; Armour, Sarah; Wittwer, Erica D; Santrach, Paula J; Meade, Laurie A; Liedl, Lavonne M; Nieuwenkamp, Chelsea M; Douthit, Brian; van Buskirk, Camille M; Schulte, Phillip J; Kor, Daryl J

2017-01-01

Introduction The transfusion-related respiratory complications, transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO), are leading causes of transfusion-related morbidity and mortality. At present, there are no effective preventive strategies with red blood cell (RBC) transfusion. Although mechanisms remain incompletely defined, soluble biological response modifiers (BRMs) within the RBC storage solution may play an important role. Point-of-care (POC) washing of allogeneic RBCs may remove these BRMs, thereby mitigating their impact on post-transfusion respiratory complications. Methods and analysis This is a multicenter randomised clinical trial of standard allogeneic versus washed allogeneic RBC transfusion for adult patients undergoing cardiac surgery testing the hypothesis that POC RBC washing is feasible, safe, and efficacious and will reduce recipient immune and physiologic responses associated with transfusion-related respiratory complications. Relevant clinical outcomes will also be assessed. This investigation will enrol 170 patients at two hospitals in the USA. Simon’s two-stage design will be used to assess the feasibility of POC RBC washing. The primary safety outcomes will be assessed using Wilcoxon Rank-Sum tests for continuous variables and Pearson chi-square test for categorical variables. Standard mixed modelling practices will be employed to test for changes in biomarkers of lung injury following transfusion. Linear regression will assess relationships between randomised group and post-transfusion physiologic measures. Ethics and dissemination Safety oversight will be conducted under the direction of an independent Data and Safety Monitoring Board (DSMB). Approval of the protocol was obtained by the DSMB as well as the institutional review boards at each institution prior to enrolling the first study participant. This study aims to provide important information regarding the feasibility of POC washing of allogeneic RBCs and its potential impact on ameliorating post-transfusion respiratory complications. Additionally, it will inform the feasibility and scientific merit of pursuing a more definitive phase II/III clinical trial. Registration ClinicalTrials.gov registration number is NCT02094118 (Pre-results). PMID:28821525

The effects of traditional, superset, and tri-set resistance training structures on perceived intensity and physiological responses.

PubMed

Weakley, Jonathon J S; Till, Kevin; Read, Dale B; Roe, Gregory A B; Darrall-Jones, Joshua; Phibbs, Padraic J; Jones, Ben

2017-09-01

Investigate the acute and short-term (i.e., 24 h) effects of traditional (TRAD), superset (SS), and tri-set (TRI) resistance training protocols on perceptions of intensity and physiological responses. Fourteen male participants completed a familiarisation session and three resistance training protocols (i.e., TRAD, SS, and TRI) in a randomised-crossover design. Rating of perceived exertion, lactate concentration ([Lac]), creatine kinase concentration ([CK]), countermovement jump (CMJ), testosterone, and cortisol concentrations was measured pre, immediately, and 24-h post the resistance training sessions with magnitude-based inferences assessing changes/differences within/between protocols. TRI reported possible to almost certainly greater efficiency and rate of perceived exertion, although session perceived load was very likely lower. SS and TRI had very likely to almost certainly greater lactate responses during the protocols, with changes in [CK] being very likely and likely increased at 24 h, respectively. At 24-h post-training, CMJ variables in the TRAD protocol had returned to baseline; however, SS and TRI were still possibly to likely reduced. Possible increases in testosterone immediately post SS and TRI protocols were reported, with SS showing possible increases at 24-h post-training. TRAD and SS showed almost certain and likely decreases in cortisol immediately post, respectively, with TRAD reporting likely decreases at 24-h post-training. SS and TRI can enhance training efficiency and reduce training time. However, acute and short-term physiological responses differ between protocols. Athletes can utilise SS and TRI resistance training, but may require additional recovery post-training to minimise effects of fatigue.

A modification of the trans-oesophageal echocardiography protocol can reduce post-operative dysphagia following cardiac surgery.

PubMed

Chin, J-H; Lee, E-H; Choi, D-K; Choi, I-C

2011-01-01

Use of intra-operative trans-oesophageal echocardiography (TEE) is an independent risk factor for post-operative dysphagia. This study investigated whether modifying the TEE probe-placement protocol could reduce the incidence of post-operative dysphagia. In group I (n = 100), the TEE probe was inserted after anaesthetic induction and remained in place until the completion of surgery. In group II (n = 100), the TEE probe was inserted after anaesthetic induction, the heart was examined, then the probe was removed. The probe was inserted again before weaning from cardiopulmonary bypass and then immediately removed after examination. The incidence of dysphagia was significantly higher in group I than in group II patients (51.1% versus 28.6%). Multivariate regression analysis showed that the length of time that the TEE probe was in the oesophagus was an independent predictor of dysphagia. Modification of the TEE protocol in this way can reduce the incidence of post-operative dysphagia in cardiac surgery patients.

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

PubMed

1998-05-18

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to reflect a new delegation that authorizes the Division Directors, Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) to approve, disapprove, or withdraw approval of product development protocols and applications for premarket approval for medical devices.

Highly Absorbing Metal Nanolaminates for Bi-Material THz Sensors

DTIC Science & Technology

2011-09-01

NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA THESIS Approved for public release; distribution is unlimited HIGHLY ABSORBING...Prescribed by ANSI Std. 239-18 REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704-0188 Public reporting burden for this collection of information is...Government. IRB Protocol number: N/A. 12a. DISTRIBUTION / AVAILABILITY STATEMENT Approved for public release; distribution is unlimited 12b

Intricate Estimation and Assessment of Surface Conditioning of Posts to improve Interfacial Adhesion in Post-core Restorations: An in vitro Study.

PubMed

Gupta, Priyanka; Sharma, Amil; Pathak, Vivek K; Mankeliya, Saurabh; Bhardwaj, Shivanshu; Dhanare, Poorvasha

2017-12-01

Post and core restorations are routinely used for restoring grossly decayed tooth structures. Various chemical agents are known to affect the interfacial adhesions between the post and the core. Hence, we planned the present study to evaluate the effect of various post-surface treatments on the interfacial strength between the posts and composite materials that are used for building up the core portion. The present study included assessment of the effect of surface conditioning of posts on the interfacial adhesion in post-core restorations. A total of 80 clear post-tapers were included and were divided broadly into four study groups based on the type of chemical testing protocols used. Various chemical treatments included alkaline potassium permanganate, hydrogen peroxide, and phosphoric acid. The fourth group was the control group. The composite core material was used for building up the core. Testing of the tensile load was done on a universal testing machine. All the results were analyzed by the Statistical Package for the Social Sciences (SPSS) software. The highest bond strength was observed in the study group treated with alkaline potassium permanganate, while the lowest was observed in the control group followed by the hydrogen peroxide group. While comparing the mean bond strength in between various study groups, significant results were obtained. Chemical treatment protocol significantly alters the mean bond strength of the post and core restoration. Potassium permanganate significantly increases the bond strength between the fiber post and core restoration.

13 CFR 302.18 - Post-approval requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Section 302.18 Business Credit and Assistance ECONOMIC DEVELOPMENT ADMINISTRATION, DEPARTMENT OF COMMERCE... Federal cost principles (collectively, “Post-Approval Requirements”). A Recipient's failure to comply with... Assistance award, or other adverse consequences to the Recipient. (b) Part 307 (Economic Adjustment...

Study of accent-based music speech protocol development for improving voice problems in stroke patients with mixed dysarthria.

PubMed

Kim, Soo Ji; Jo, Uiri

2013-01-01

Based on the anatomical and functional commonality between singing and speech, various types of musical elements have been employed in music therapy research for speech rehabilitation. This study was to develop an accent-based music speech protocol to address voice problems of stroke patients with mixed dysarthria. Subjects were 6 stroke patients with mixed dysarthria and they received individual music therapy sessions. Each session was conducted for 30 minutes and 12 sessions including pre- and post-test were administered for each patient. For examining the protocol efficacy, the measures of maximum phonation time (MPT), fundamental frequency (F0), average intensity (dB), jitter, shimmer, noise to harmonics ratio (NHR), and diadochokinesis (DDK) were compared between pre and post-test and analyzed with a paired sample t-test. The results showed that the measures of MPT, F0, dB, and sequential motion rates (SMR) were significantly increased after administering the protocol. Also, there were statistically significant differences in the measures of shimmer, and alternating motion rates (AMR) of the syllable /K$\\inve$/ between pre- and post-test. The results indicated that the accent-based music speech protocol may improve speech motor coordination including respiration, phonation, articulation, resonance, and prosody of patients with dysarthria. This suggests the possibility of utilizing the music speech protocol to maximize immediate treatment effects in the course of a long-term treatment for patients with dysarthria.

Good news and bad news: the cost of mending a broken heart.

PubMed

Williams, David

2003-01-01

The approval of a new treatment protocol known as "destination therapy" highlights the realities of today's health economics. This article discusses the technology, the economics and the philosophy of the newly approved left-ventricular-assist systems.

21 CFR 58.35 - Quality assurance unit.

Code of Federal Regulations, 2013 CFR

2013-04-01

... the corrective actions taken. (5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and...

21 CFR 58.35 - Quality assurance unit.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the corrective actions taken. (5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and...

21 CFR 58.35 - Quality assurance unit.

Code of Federal Regulations, 2012 CFR

2012-04-01

... the corrective actions taken. (5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and...

21 CFR 58.35 - Quality assurance unit.

Code of Federal Regulations, 2011 CFR

2011-04-01

... the corrective actions taken. (5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and...

21 CFR 58.35 - Quality assurance unit.

Code of Federal Regulations, 2014 CFR

2014-04-01

... the corrective actions taken. (5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and...

Flow-mediated Dilation: Can New Approaches Provide Greater Mechanistic Insight into Vascular Dysfunction in Preeclampsia and Other Diseases?

PubMed Central

Weissgerber, Tracey L.

2015-01-01

Endothelial dysfunction is a key feature of preeclampsia, and may contribute to increased cardiovascular disease risk years after pregnancy. Flow-mediated dilation (FMD) is a non-invasive endothelial function test that predicts cardiovascular event risk. New protocols allow researchers to measure three components of the FMD response: FMD, low flow-mediated constriction and the shear stimulus. This review encourages researchers to think beyond “low FMD” by examining how these three components may provide additional insights into the mechanisms and location of vascular dysfunction. The review then examines what FMD studies reveal about vascular dysfunction in preeclampsia, while highlighting opportunities to gain greater mechanistic insight from new protocols. Studies using traditional protocols show that FMD is low in mid-pregnancy prior to preeclampsia, at diagnosis, and for three years post-partum. However, FMD returns to normal by ten years post-partum. Studies using new protocols are needed to gain more mechanistic insight. PMID:25182159

Flow-mediated dilation: can new approaches provide greater mechanistic insight into vascular dysfunction in preeclampsia and other diseases?

PubMed

Weissgerber, Tracey L

2014-11-01

Endothelial dysfunction is a key feature of preeclampsia and may contribute to increased cardiovascular disease risk years after pregnancy. Flow-mediated dilation (FMD) is a non-invasive endothelial function test that predicts cardiovascular event risk. New protocols allow researchers to measure three components of the FMD response: FMD, low flow-mediated constriction, and shear stimulus. This review encourages researchers to think beyond "low FMD" by examining how these three components may provide additional insights into the mechanisms and location of vascular dysfunction. The review then examines what FMD studies reveal about vascular dysfunction in preeclampsia while highlighting opportunities to gain greater mechanistic insight from new protocols. Studies using traditional protocols show that FMD is low in mid-pregnancy prior to preeclampsia, at diagnosis, and for 3 years post-partum. However, FMD returns to normal by 10 years post-partum. Studies using new protocols are needed to gain more mechanistic insight.

Study protocol for a randomised controlled trial of cognitive processing therapy for post-traumatic stress disorder among Japanese patients: the Safety, Power, Intimacy, Esteem, Trust (SPINET) study.

PubMed

Ito, Masaya; Horikoshi, Masaru; Resick, Patricia A; Katayanagi, Akiko; Miyamae, Mitsuhiro; Takagishi, Yuriko; Takebayashi, Yoshitake; Kanie, Ayako; Hirabayashi, Naotsugu; Furukawa, Toshiaki A

2017-06-30

Cognitive processing therapy (CPT) is widely regarded as a safe and effective first-line treatment for individuals with post-traumatic stress disorder (PTSD); however, no comparative studies have been conducted to examine the treatment outcomes in an Asian population. The aim of the present trial is to investigate the efficacy of CPT (individual format) as a treatment for PTSD in a population of Japanese patients. A 16-week, single-centre, assessor-masked, randomised, parallel-group superiority trial has been designed to compare the efficacy of CPT in conjunction with treatment as usual (mostly pharmacotherapy and clinical monitoring) versus treatment as usual alone. The Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) will be our primary outcome measure of the post-traumatic stress symptoms at 17 weeks, whereas the PTSD Checklist for DSM-5 and determination of the operationally defined responder status will be used to assess the secondary outcomes. An estimated sample size of 29 participants in each group will be required to detect an expected effect size of 1.4 (95% CI 0.85 to 1.95). The institutional review board at the National Center of Neurology and Psychiatry in Japan approved this study. The results of this clinical trial will be presented at conferences and disseminated through publication in a peer-reviewed journal. UMIN000021670 (registered on 1 April 2016). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Promoting Optimal Physical Exercise for Life (PROPEL): aerobic exercise and self-management early after stroke to increase daily physical activity—study protocol for a stepped-wedge randomised trial

PubMed Central

Mansfield, Avril; Brooks, Dina; Tang, Ada; Taylor, Denise; Inness, Elizabeth L; Kiss, Alex; Middleton, Laura; Biasin, Louis; Fleck, Rebecca; French, Esmé; LeBlanc, Kathryn; Aqui, Anthony; Danells, Cynthia

2017-01-01

Introduction Physical exercise after stroke is essential for improving recovery and general health, and reducing future stroke risk. However, people with stroke are not sufficiently active on return to the community after rehabilitation. We developed the Promoting Optimal Physical Exercise for Life (PROPEL) programme, which combines exercise with self-management strategies within rehabilitation to promote ongoing physical activity in the community after rehabilitation. This study aims to evaluate the effect of PROPEL on long-term participation in exercise after discharge from stroke rehabilitation. We hypothesise that individuals who complete PROPEL will be more likely to meet recommended frequency, duration and intensity of exercise compared with individuals who do not complete the programme up to 6 months post discharge from stroke rehabilitation. Methods and analysis Individuals undergoing outpatient stroke rehabilitation at one of six hospitals will be recruited (target n=192 total). A stepped-wedge design will be employed; that is, the PROPEL intervention (group exercise plus self-management) will be ‘rolled out’ to each site at a random time within the study period. Prior to roll-out of the PROPEL intervention, sites will complete the control intervention (group aerobic exercise only). Participation in physical activity for 6 months post discharge will be measured via activity and heart rate monitors, and standardised physical activity questionnaire. Adherence to exercise guidelines will be evaluated by (1) number of ‘active minutes’ per week (from the activity monitor), (2) amount of time per week when heart rate is within a target range (ie, 55%–80% of age-predicted maximum) and (3) amount of time per week completing ‘moderate’ or ‘strenuous’ physical activities (from the questionnaire). We will compare the proportion of active and inactive individuals at 6 months post intervention using mixed-model logistic regression, with fixed effects of time and phase and random effect of cluster (site). Ethics and dissemination To date, research ethics approval has been received from five of the six sites, with conditional approval granted by the sixth site. Results will be disseminated directly to study participants at the end of the trial, and to other stake holders via publication in a peer-reviewed journal. Trial registration number NCT02951338; Pre-results. PMID:28667222

Post-plyometric exercise hypotension and heart rate in normotensive individuals: influence of exercise intensity.

PubMed

Arazi, Hamid; Asadi, Abbas; Rahimzadeh, Mehdi; Moradkhani, Amir-Hossein

2013-12-01

The purpose of this study was to compare the effects of high, moderate and low intensity plyometric exercise on the post-exercise systolic and diastolic blood pressure and heart rate responses. Ten healthy normotensive men (age, 21.1±0.9 years; height, 175.8±6 cm; and body mass, 69.1±13.6 kg) volunteered to participate in this study and were evaluated for three non-consecutive days in depth jump exercise from 20-cm box (low intensity [LI]), 40-cm box (moderate intensity [MI]) and 60-cm box (high intensity [HI]) for 5 sets of 20 repetitions. After each exercise session, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured every 10 min for a period of 90 min. No significant differences were observed among post-exercise SBP, DBP and HR when the protocols (LI, MI and HI) were compared. The LI and HI protocols showed greater reduction in SBP at 40(th)-70(th) min of post-exercise (~9%), whereas the LI and MI protocols indicated greater reduction in DBP at 10(th)-50(th) min of post exercise (~10%). In addition, the change in the DBP for HI was not significant and the increases in the HR were similar for all intensities. It can be concluded that a plyometric exercise (PE) can reduce SBP and DBP post-exercise and therefore we can say that PE has significant effects for reducing BP and HR or post-exercise hypotension.

Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

PubMed

Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram

2016-01-01

Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.

"We need a mechanism to report abuses of women's human rights".

PubMed

Facio, A

1996-01-01

This article discusses the Optional Protocol of the Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW). This convention is the only instrument protecting the human rights of women at the international level. However, even if the convention was the best possible women's human rights documentation, there was no mechanism for reporting the abuses. The women's movement has long been pressing for the approval of the mechanism like the Optional Protocol, because they believe that the Protocol would fulfill the need in allowing the individual and collective accusations of human rights abuses. It means that a woman or a group of women can go to the committee and denounce an action as discriminatory. The committee can only receive reports and make recommendations, whereas having a Protocol would allow the committee to direct complaints, be able to investigate them, and make more specific recommendations. Those countries ratifying the CEDAW don't automatically agree to the Protocol, thus it is the country's discretion to either comply with the Protocol or not. There are also those who are against the Protocol and claim ironically that an Optional Protocol for Political and Civil rights already exists. But such mechanisms do not work for women's rights. What is most needed now is to lobby all national delegations to push the 5th Commission of the United Nations' General Assembly to approve the budget for the protocol.

The effectiveness of Korean medicine treatment in male patients with infertility: a study protocol for a prospective observational pilot study.

PubMed

Kim, Kwan-Ii; Jo, Junyoung

2018-01-01

Male factor subfertility has increasingly been considered the cause of infertility in couples. Many men with male infertility have sperm problems such as oligozoospermia, asthenozoospermia, or teratozoospermia. Because abnormal semen parameters are idiopathic to some extent, no standard therapy has been established to date. Herbal medicine has been reported to have beneficial properties in the treatment of subfertility, especially in improving semen quality both in vivo and in human studies. Therefore, we intend to investigate the effectiveness and safety of treatment using Korean medicine (KM) for infertile male patients with poor semen quality.This will be a single-center, prospective, case-only observational pilot study. About 20 male patients with infertility who visit Conmaul Hospital of Korean Medicine will be recruited. We will follow the standard treatment protocol, which has shown good results in the treatment of male infertility. The protocol is composed mainly of a 10-week herbal decoction treatment; acupuncture and/or pharmacopuncture are added when needed. Semen samples, quality of life, and the scrotal temperatures of infertile men will be observed before and after the 10-week treatment with KM.The study has received ethical approval from the Public Institutional Review Board (approval number: P01-201708-21-008). The findings will be disseminated to appropriate audiences via peer-reviewed publication and conference presentations. Korean Clinical Trial Registry (CRIS), Republic of Korea: KCT0002611.

From QASC to QASCIP: successful Australian translational scale-up and spread of a proven intervention in acute stroke using a prospective pre-test/post-test study design

PubMed Central

Lydtin, Anna; Comerford, Daniel; Cadilhac, Dominique A; McElduff, Patrick; Dale, Simeon; Hill, Kelvin; Longworth, Mark; Ward, Jeanette; Cheung, N Wah; D'Este, Cate

2016-01-01

Objectives To embed an evidence-based intervention to manage FEver, hyperglycaemia (Sugar) and Swallowing (the FeSS protocols) in stroke, previously demonstrated in the Quality in Acute Stroke Care (QASC) trial to decrease 90-day death and dependency, into all stroke services in New South Wales (NSW), Australia's most populous state. Design Pre-test/post-test prospective study. Setting 36 NSW stroke services. Methods Our clinical translational initiative, the QASC Implementation Project (QASCIP), targeted stroke services to embed 3 nurse-led clinical protocols (the FeSS protocols) into routine practice. Clinical champions attended a 1-day multidisciplinary training workshop and received standardised educational resources and ongoing support. Using the National Stroke Foundation audit collection tool and processes, patient data from retrospective medical record self-reported audits for 40 consecutive patients with stroke per site pre-QASCIP (1 July 2012 to 31 December 2012) were compared with prospective self-reported data from 40 consecutive patients with stroke per site post-QASCIP (1 November 2013 to 28 February 2014). Inter-rater reliability was substantial for 10 of 12 variables. Primary outcome measures Proportion of patients receiving care according to the FeSS protocols pre-QASCIP to post-QASCIP. Results All 36 (100%) NSW stroke services participated, nominating 100 site champions who attended our educational workshops. The time from start of intervention to completion of post-QASCIP data collection was 8 months. All (n=36, 100%) sites provided medical record audit data for 2144 patients (n=1062 pre-QASCIP; n=1082 post-QASCIP). Pre-QASCIP to post-QASCIP, proportions of patients receiving the 3 targeted clinical behaviours increased significantly: management of fever (pre: 69%; post: 78%; p=0.003), hyperglycaemia (pre: 23%; post: 34%; p=0.0085) and swallowing (pre: 42%; post: 51%; p=0.033). Conclusions We obtained unprecedented statewide scale-up and spread to all NSW stroke services of a nurse-led intervention previously proven to improve long-term patient outcomes. As clinical leaders search for strategies to improve quality of care, our initiative is replicable and feasible in other acute care settings. PMID:27154485

Development of an HPV Educational Protocol for Adolescents

PubMed Central

Wetzel, Caitlin; Tissot, Abbigail; Kollar, Linda M.; Hillard, Paula A.; Stone, Rachel; Kahn, Jessica A.

2007-01-01

Study Objectives To develop an educational protocol about HPV and Pap tests for adolescents, to evaluate the protocol for understandability and clarity, and to evaluate the protocol for its effectiveness in increasing knowledge about HPV. Design In phase 1, investigators and adolescents developed the protocol. In phase 2, adolescents evaluated the protocol qualitatively, investigators evaluated its effectiveness in increasing HPV knowledge in a sample of adolescents, and the protocol was revised. In phase 3, investigators evaluated the effectiveness of the revised protocol in an additional adolescent sample. Setting Urban, hospital-based teen health center. Participants A total of 252 adolescent girls and boys in the three study phases. Main Outcome Measures Pre- and post-protocol knowledge about HPV, measured using a 10- or 11-item scale. Results Scores on the HPV knowledge scale increased significantly (p<.0001) among adolescents who participated in phases 2 and 3 after they received the protocol. Initial differences in scores based on race, insurance type and condom use were not noted post-protocol. Conclusion The protocol significantly increased knowledge scores about HPV in this population, regardless of sociodemographic characteristics and risk behaviors. Effective, developmentally appropriate educational protocols about HPV and Pap tests are particularly important in clinical settings as cervical cancer screening guidelines evolve, HPV DNA testing is integrated into screening protocols, and HPV vaccines become available. In-depth, one-on-one education about HPV may also prevent adverse psychosocial responses and promote healthy sexual and Pap screening behaviors in adolescents with abnormal HPV or Pap test results. Synopsis The investigators developed an educational protocol about HPV and Pap tests and evaluated its effectiveness in increasing knowledge about HPV among adolescents. PMID:17868894

Abbreviated Combined MR Protocol: A New Faster Strategy for Characterizing Breast Lesions.

PubMed

Moschetta, Marco; Telegrafo, Michele; Rella, Leonarda; Stabile Ianora, Amato Antonio; Angelelli, Giuseppe

2016-06-01

The use of an abbreviated magnetic resonance (MR) protocol has been recently proposed for cancer screening. The aim of our study is to evaluate the diagnostic accuracy of an abbreviated MR protocol combining short TI inversion recovery (STIR), turbo-spin-echo (TSE)-T2 sequences, a pre-contrast T1, and a single intermediate (3 minutes after contrast injection) post-contrast T1 sequence for characterizing breast lesions. A total of 470 patients underwent breast MR examination for screening, problem solving, or preoperative staging. Two experienced radiologists evaluated both standard and abbreviated protocols in consensus. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and diagnostic accuracy for both protocols were calculated (with the histological findings and 6-month ultrasound follow-up as the reference standard) and compared with the McNemar test. The post-processing and interpretation times for the MR images were compared with the paired t test. In 177 of 470 (38%) patients, the MR sequences detected 185 breast lesions. Standard and abbreviated protocols obtained sensitivity, specificity, diagnostic accuracy, PPV, and NPV values respectively of 92%, 92%, 92%, 68%, and 98% and of 89%, 91%, 91%, 64%, and 98% with no statistically significant difference (P < .0001). The mean post-processing and interpretation time were, respectively, 7 ± 1 minutes and 6 ± 3.2 minutes for the standard protocol and 1 ± 1.2 minutes and 2 ± 1.2 minutes for the abbreviated protocol, with a statistically significant difference (P < .01). An abbreviated combined MR protocol represents a time-saving tool for radiologists and patients with the same diagnostic potential as the standard protocol in patients undergoing breast MRI for screening, problem solving, or preoperative staging. Copyright © 2016 Elsevier Inc. All rights reserved.

Effects of various etching protocols on the flexural properties and surface topography of fiber-reinforced composite dental posts.

PubMed

Aksornmuang, Juthatip; Chuenarrom, Chanya; Chittithaworn, Natjira

2017-09-26

The purpose of this study was to evaluate the flexural properties and surface topography of fiber posts surface-treated with various etching protocols. Seventy each of three types of fiber posts: RelyX Fiber Post, Tenax Fiber Trans, and D.T. Light-Post Illusion X-Ro, were randomly divided into 7 groups: no surface treatment, surface treated with hydrofluoric acid (HF) 4.5% for 60 s, HF 4.5% for 120 s, HF 9.6% for 15 s, HF 9.6% for 60 s, HF 9.6% for 120 s, and treated with H 2 O 2 24% for 10 min. The specimens were then subjected to a three-point bending test. Surface topographies of the posts were observed using a SEM. The results indicate that fiber post surface pretreatments had no adverse effects on the flexural properties. However, the fiber posts treated with high HF concentrations or long etching times seemed to have more surface irregularities.

Efficacy evaluation of an anti-caries varnish: protocol for a phase II randomised controlled trial

PubMed Central

Tut, Ohnmar; Rothen, Marilynn; Mancl, Lloyd; Gallen, Marcelle; Tanzer, Jason M

2017-01-01

Introduction Dental caries (tooth decay) is a common disease in which the products of sugar metabolism by certain bacteria that populate the tooth surface induce the development and progression of lesions (cavities). This is a phase II single-centre randomised, double-blind, active-controlled, parallel-group trial to assess the efficacy of a combination povidone iodine and sodium fluoride dental varnish to determine if it is superior to a varnish containing only sodium fluoride in the prevention of new caries lesions. The objective of this report is to describe the rationale and protocol for the trial. Methods and analysis The study site is Pohnpei State, Federated States of Micronesia. The study population is 284 children 48–84 months old. The primary outcome will be the surface-level primary molar caries increment (d2-3mfs/DMFS) at 2 years post baseline. The incremental dental caries at 1 year will also be compared between the two interventions. The secondary outcome is the Facial Image Scale after the initial treatment and after the fifth treatment at 1 year that gauges the child’s response to the treatment. Ethics and dissemination The Western Institutional Review Board (designated IRB) and the Institutional Review Board of the College of Micronesia-FSM approved all study procedures. The US Food and Drug Administration (FDA) has issued IND 128835 covering this study. The study results will be published and submitted to the FDA in support of a new drug application. Trialregistration number NCT03082196. PMID:28667230

COGNITIVE-HD study: protocol of an observational study of neurocognitive functioning and association with clinical outcomes in adults with end-stage kidney disease treated with haemodialysis.

PubMed

Palmer, Suetonia C; Ruospo, Marinella; Barulli, Maria Rosaria; Iurillo, Annalisa; Saglimbene, Valeria; Natale, Patrizia; Gargano, Letizia; Murgo, Angelo M; Loy, Clement; van Zwieten, Anita; Wong, Germaine; Tortelli, Rosanna; Craig, Jonathan C; Johnson, David W; Tonelli, Marcello; Hegbrant, Jörgen; Wollheim, Charlotta; Logroscino, Giancarlo; Strippoli, G F M

2015-12-09

The prevalence of cognitive impairment may be increased in adults with end-stage kidney disease compared with the general population. However, the specific patterns of cognitive impairment and association of cognitive dysfunction with activities of daily living and clinical outcomes (including withdrawal from treatment) among haemodialysis patients remain incompletely understood. The COGNITIVE impairment in adults with end-stage kidney disease treated with HemoDialysis (COGNITIVE-HD) study aims to characterise the age-adjusted and education-adjusted patterns of cognitive impairment (using comprehensive testing for executive function, perceptual-motor function, language, learning and memory, and complex attention) in patients on haemodialysis and association with clinical outcomes. A prospective, longitudinal, cohort study of 750 adults with end-stage kidney disease treated with long-term haemodialysis has been recruited within haemodialysis centres in Italy (July 2013 to April 2014). Testing for neurocognitive function was carried out by a trained psychologist at baseline to assess cognitive functioning. The primary study factor is cognitive impairment and secondary study factors will be specific domains of cognitive function. The primary outcome will be total mortality. Secondary outcomes will be cause-specific mortality, major cardiovascular events, fatal and non-fatal myocardial infarction and stroke, institutionalisation, and withdrawal from treatment at 12 months. This protocol was approved before study conduct by the following responsible ethics committees: Catania (approval reference 186/BE; 26/09/2013), Agrigento (protocol numbers 61-62; 28/6/2013), USL Roma C (CE 39217; 24/6/2013), USL Roma F (protocol number 0041708; 23/7/2013), USL Latina (protocol number 20090/A001/2011; 12/7/2013), Trapani (protocol number 3413; 16/7/2013) and Brindisi (protocol number 40259; 6/6/2013). All participants have provided written and informed consent and can withdraw from the study at any time. The findings of the study will be disseminated through peer-reviewed journals and national and international conference presentations and to the participants through communication within the dialysis network in which this study is conducted. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

75 FR 39250 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-08

... Protocol Gas Verification Program; EPA ICR No. 2375.01, OMB Control Number 2060-NEW AGENCY: Environmental... Air Protocol Gas Verification Program. ICR numbers: EPA ICR No. 2375.01, OMB Control No. 2060-NEW. ICR...

Verification of performance specifications for a US Food and Drug Administration-approved molecular microbiology test: Clostridium difficile cytotoxin B using the Becton, Dickinson and Company GeneOhm Cdiff assay.

PubMed

Schlaberg, Robert; Mitchell, Michael J; Taggart, Edward W; She, Rosemary C

2012-01-01

US Food and Drug Administration (FDA)-approved diagnostic tests based on molecular genetic technologies are becoming available for an increasing number of microbial pathogens. Advances in technology and lower costs have moved molecular diagnostic tests formerly performed for research purposes only into much wider use in clinical microbiology laboratories. To provide an example of laboratory studies performed to verify the performance of an FDA-approved assay for the detection of Clostridium difficile cytotoxin B compared with the manufacturer's performance standards. We describe the process and protocols used by a laboratory for verification of an FDA-approved assay, assess data from the verification studies, and implement the assay after verification. Performance data from the verification studies conducted by the laboratory were consistent with the manufacturer's performance standards and the assay was implemented into the laboratory's test menu. Verification studies are required for FDA-approved diagnostic assays prior to use in patient care. Laboratories should develop a standardized approach to verification studies that can be adapted and applied to different types of assays. We describe the verification of an FDA-approved real-time polymerase chain reaction assay for the detection of a toxin gene in a bacterial pathogen.

Protocol Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. KEY ROLES/RESPONSIBILITIES The Protocol Coordinator II: Provides comprehensive clinical and administrative support to the Brain Tumor Trial Collaborative, Neuro-Oncology Branch, NCI, National Institutes of Health Serves as a liaison with Principal Investigators (PIs), the associated study teams and a variety of offices associated with protocol development and approvals Orchestrates meetings with investigators and other key medical staff to identify required support Coordinates the writing and regulatory review processes that occur in tandem, facilitates the bi-directional dialogue and feedback between various teams, and assists investigators and medical writers on the production/revision of clinical research protocols Assists research staff in coordinating/navigating requirements for special circumstances and facilitates access to necessary services Facilitates initiation of intramural research by providing assistance in obtaining required approvals Coordinates with investigators and medical writers to ensure Institutional Review Board (IRB) and Food and Drug Administration (FDA) stipulations are appropriately addressed in a timely manner Provides consultation and assistance for all aspects of the protocol lifecycle including initial Investigational New Drug (IND) submission, IRB submission, continuing review applications, protocol amendments, annual reports, and protocol inactivation with IRB and FDA Tracks a portfolio of protocols through each lifecycle step; processes and tracks appropriate approvals (e.g., IRB, Data and Safety Monitoring Board, Radiation Safety, Office of Protocol Services, etc.) Provides administrative support to Scientific Review Committees (SRC), reviews proposed protocol documents to ensure they are complete, distributes to reviewers, documents meeting minutes, enters data into the IRIS database, facilitates processes to obtain approval to initiate and continue clinical research Creates, maintains and queries an IRB database of approved amendment descriptions Maintains records of the current protocol(s) version, current Informed Consent document(s), FDA Safe to Proceed designation, etc. for each IND Provides expertise in data management including data collection and analysis Develops procedural manuals for clinical trials protocols Participates in quality improvement and assurance involving International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines This position is located at the National Institutes of Health (NIH) in Bethesda, Maryland.

13 CFR 307.6 - Economic Adjustment Assistance post-approval requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Economic Adjustment Assistance post-approval requirements. 307.6 Section 307.6 Business Credit and Assistance ECONOMIC DEVELOPMENT ADMINISTRATION, DEPARTMENT OF COMMERCE ECONOMIC ADJUSTMENT ASSISTANCE INVESTMENTS General § 307.6 Economic...

13 CFR 307.6 - Economic Adjustment Assistance post-approval requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 false Economic Adjustment Assistance post-approval requirements. 307.6 Section 307.6 Business Credit and Assistance ECONOMIC DEVELOPMENT ADMINISTRATION, DEPARTMENT OF COMMERCE ECONOMIC ADJUSTMENT ASSISTANCE INVESTMENTS General § 307.6 Economic...

13 CFR 307.6 - Economic Adjustment Assistance post-approval requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 13 Business Credit and Assistance 1 2012-01-01 2012-01-01 false Economic Adjustment Assistance post-approval requirements. 307.6 Section 307.6 Business Credit and Assistance ECONOMIC DEVELOPMENT ADMINISTRATION, DEPARTMENT OF COMMERCE ECONOMIC ADJUSTMENT ASSISTANCE INVESTMENTS General § 307.6 Economic...

13 CFR 307.6 - Economic Adjustment Assistance post-approval requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 13 Business Credit and Assistance 1 2014-01-01 2014-01-01 false Economic Adjustment Assistance post-approval requirements. 307.6 Section 307.6 Business Credit and Assistance ECONOMIC DEVELOPMENT ADMINISTRATION, DEPARTMENT OF COMMERCE ECONOMIC ADJUSTMENT ASSISTANCE INVESTMENTS General § 307.6 Economic...

13 CFR 307.6 - Economic Adjustment Assistance post-approval requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 13 Business Credit and Assistance 1 2013-01-01 2013-01-01 false Economic Adjustment Assistance post-approval requirements. 307.6 Section 307.6 Business Credit and Assistance ECONOMIC DEVELOPMENT ADMINISTRATION, DEPARTMENT OF COMMERCE ECONOMIC ADJUSTMENT ASSISTANCE INVESTMENTS General § 307.6 Economic...

Sedation protocol with fasting and shorter sleep leads to magnetic resonance imaging success.

PubMed

Kimiya, Takahisa; Sekiguchi, Shinichiro; Yagihashi, Tatsuhiko; Arai, Mie; Takahashi, Hirotaka; Takahashi, Takao

2017-10-01

Young children undergoing magnetic resonance imaging (MRI) require sedation. In June 2013, Tokyo Metropolitan Ohtsuka Hospital (TMOH) introduced an oral sedation protocol for young children undergoing MRI; the protocol included instructions on fasting before sedation, and recommended a shorter duration of sleep the night before MRI. We compared the MRI success rate before and after the introduction of this protocol. The eligible subjects were children under 3 years old who underwent MRI by appointment at TMOH between October 2012 and March 2014, under sedation with triclofos sodium. All those who underwent MRI in or after June 2013 were enrolled prospectively as a post-protocol group. All patients who underwent MRI before June 2013 were enrolled retrospectively as a pre-protocol group, with data collected from chart review. Seventy-four patients were enrolled in the post-protocol group, and 42 in the pre-protocol group. The MRI success rate was significantly higher in the post-protocol group than in the pre-protocol group (98.7% vs 88.1%), as was the rate of on-time starting of MRI (86.5% vs 71.4%). The post-protocol group woke up earlier on the day of examination (6:18 a.m. vs 6:43 a.m.), resulting in a significantly longer time between awakening and the beginning of sedation (289.8 min vs 265.9 min), and a significantly shorter average duration of sleep on the previous night (504.8 min vs 532.3 min). Implementation of a hospital-wide sedation protocol for young children undergoing MRI significantly improved the MRI success rate. © 2017 Japan Pediatric Society.

40 CFR 1043.50 - Approval of methods to meet Tier 1 retrofit NOX standards.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Approval of methods to meet Tier 1... SUBJECT TO THE MARPOL PROTOCOL § 1043.50 Approval of methods to meet Tier 1 retrofit NOX standards... enable Pre-Tier 1 engines to meet the Tier 1 NOX standard of regulation 13 of Annex VI. Any person may...

Protocol Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases.  CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive clinical and administrative support to the National Cancer Institute’s Center for Cancer Research’s (CCR), Office of Regulatory Affairs for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration. KEY ROLES/RESPONSIBILITIES - THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL The Protocol Coordinator II: Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials Provides deployment of clinical support services for clinical research Streamlines protocol development timeline Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities Provides administrative coordination and general logistical support for regulatory activities Ensures the provision of training for investigators and associate staff to reinforce and enhance a GCP culture Provides quality assurance and quality control oversight Performs regulatory review of clinical protocols, informed consent and other clinical documents Tracks and facilitates a portfolio of protocols through each process step (IRB, RAC, DSMB, Office of Protocol Services) Assists clinical investigators in preparing clinical research protocols, including writing and formatting protocol documents and consent forms Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with CCR, NCI and NIH policies Collaborates with investigators to resolve any protocol/data issues Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI Institutional Review Board (IRB) and the clinical trial sponsor or the FDA Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events Attends and prepares minutes for the Branch Protocol Review Committees For protocols that are performed with other research centers: contacts coordinators at other centers to obtain review committee approvals at these centers, maintains records of these approvals at the outside centers in the protocol files, and sends protocol amendments and other reports to the participating centers Maintains a schedule of all review committee submission deadline dates and meeting dates Assists clinical investigators in understanding and complying with the entire review process Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document management and tracking system for NCI protocols Converts protocols from Word format to PDF with bookmarks Maintains the PDF version of the most current approved version of each active clinical protocol on a central server    This position has the option to be located in Frederick or Rockville, Maryland.

Mitroflow DL Post Approval Study- North America

ClinicalTrials.gov

2017-12-04

Aortic Stenosis; Aortic Regurgitation; Aortic Valve Insufficiency; Heart Valve Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Heart Diseases; Pathological Conditions, Anatomical

Oral hygiene compliance in orthodontic patients: a randomized controlled study on the effects of a post-treatment communication.

PubMed

Cozzani, Mauro; Ragazzini, Giulia; Delucchi, Alessia; Mutinelli, Sabrina; Barreca, Carlo; Rinchuse, Daniel J; Servetto, Roberto; Piras, Vincenzo

2016-12-01

Several studies have recently demonstrated that a post-treatment communication to explain the importance of an oral hygiene can improve the orthodontic patients' compliance over a period of 66 days. The main goal of this study is to evaluate the effects of a structured follow-up communication after orthodontic appliance application on oral hygiene compliance after 30-40 days. Eighty-four orthodontic participants enrolled from patients who were beginning fixed orthodontic treatment at the Orthodontic Department, Gaslini Hospital, Genova, between July and October 2014 were randomly assigned to one of three trial arms. Before the bonding, all patients underwent a session of oral hygiene aimed at obtaining an plaque index of "zero." At the following orthodontic appointment, the plaque index was calculated for each patient in order to assess oral hygiene compliance. The first group served as control and did not receive any post-procedure communication, the second group received a structured text message giving reassurance, and the third group received a structured telephone call. Participants were blinded to group assignment and were not made aware that the text message or the telephone call was part of the study. (The research protocol was approved by the Italian Comitato Etico Regionale della Liguria-sezione 3^ c/o IRCCS-Istituto G. Gaslini 845/2014, and it is not registered in the trial's register.) RESULTS: Thirty patients were randomly assigned to the control group, 28 participants to the text message group, and 26 to the telephone group. Participants who received a post-treatment communication reported higher level of oral hygiene compliance than participants in the control group. The plaque index was 0.3 (interquartile range (Iqr), 0.60) and 0.75 (Iqr, 1.30), respectively, with a significant difference (P = 0.0205). A follow-up procedure after orthodontic treatment may be an effective tool to increase oral hygiene compliance also over a short period.

21 CFR 884.5320 - Glans sheath.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the entire shaft of the penis. It is indicated only for the prevention of pregnancy and not for the prevention of sexually-transmitted diseases. (b) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is...

Orthogonal-state-based cryptography in quantum mechanics and local post-quantum theories

NASA Astrophysics Data System (ADS)

Aravinda, S.; Banerjee, Anindita; Pathak, Anirban; Srikanth, R.

2014-02-01

We introduce the concept of cryptographic reduction, in analogy with a similar concept in computational complexity theory. In this framework, class A of crypto-protocols reduces to protocol class B in a scenario X, if for every instance a of A, there is an instance b of B and a secure transformation X that reproduces a given b, such that the security of b guarantees the security of a. Here we employ this reductive framework to study the relationship between security in quantum key distribution (QKD) and quantum secure direct communication (QSDC). We show that replacing the streaming of independent qubits in a QKD scheme by block encoding and transmission (permuting the order of particles block by block) of qubits, we can construct a QSDC scheme. This forms the basis for the block reduction from a QSDC class of protocols to a QKD class of protocols, whereby if the latter is secure, then so is the former. Conversely, given a secure QSDC protocol, we can of course construct a secure QKD scheme by transmitting a random key as the direct message. Then the QKD class of protocols is secure, assuming the security of the QSDC class which it is built from. We refer to this method of deduction of security for this class of QKD protocols, as key reduction. Finally, we propose an orthogonal-state-based deterministic key distribution (KD) protocol which is secure in some local post-quantum theories. Its security arises neither from geographic splitting of a code state nor from Heisenberg uncertainty, but from post-measurement disturbance.

Effect of various practical warm-up protocols on acute lower-body power.

PubMed

Buttifant, David; Hrysomallis, Con

2015-03-01

The purpose of this study was to compare the acute effect of box squats with barbell (BBSquat), box squats with elastic resistance bands (BandSquat), and static stretches (SStretch) on external power during a 20-kg weighted jump squat. Twelve male athletes performed each of the 3 warm-up protocols on separate occasions in a randomized order. Weighted jump squat power was assessed using a linear position transducer attached to the bar of a Smith machine. Jump power was measured pre-warm-up and 5 and 10 minutes post-warm-up protocol. The BBSquat protocol involved 3 sets of 3RM, BandSquat involved 3 sets of 3 repetitions using highest resistance elastic bands, and the SStretch protocol comprises two 30-second stretches for muscles of the lower limbs. Jump power significantly increased from pre-warm-up to 5 and 10 minutes post-warm-up for both the BandSquat and BBSquat protocols. There was no statistical difference in power values between BandSquat and BBSquat. Power output significantly decreased from pre-warm-up to 5 and 10 minutes post-warm-up for the SStretch protocol. The BandSquat was just as effective as BBSquat in augmenting acute jump power. The SStretch was detrimental to jump performance. A practical warm-up using relatively inexpensive and portable equipment such as elastic resistance bands was just as effective as a warm-up protocol that requires more substantial and less transportable equipment such as a squat rack and associated free weights. The BandSquat warm-up may be considered more accessible for athletes at various competition levels.

The ADVANCE Code of Conduct for collaborative vaccine studies.

PubMed

Kurz, Xavier; Bauchau, Vincent; Mahy, Patrick; Glismann, Steffen; van der Aa, Lieke Maria; Simondon, François

2017-04-04

Lessons learnt from the 2009 (H1N1) flu pandemic highlighted factors limiting the capacity to collect European data on vaccine exposure, safety and effectiveness, including lack of rapid access to available data sources or expertise, difficulties to establish efficient interactions between multiple parties, lack of confidence between private and public sectors, concerns about possible or actual conflicts of interest (or perceptions thereof) and inadequate funding mechanisms. The Innovative Medicines Initiative's Accelerated Development of VAccine benefit-risk Collaboration in Europe (ADVANCE) consortium was established to create an efficient and sustainable infrastructure for rapid and integrated monitoring of post-approval benefit-risk of vaccines, including a code of conduct and governance principles for collaborative studies. The development of the code of conduct was guided by three core and common values (best science, strengthening public health, transparency) and a review of existing guidance and relevant published articles. The ADVANCE Code of Conduct includes 45 recommendations in 10 topics (Scientific integrity, Scientific independence, Transparency, Conflicts of interest, Study protocol, Study report, Publication, Subject privacy, Sharing of study data, Research contract). Each topic includes a definition, a set of recommendations and a list of additional reading. The concept of the study team is introduced as a key component of the ADVANCE Code of Conduct with a core set of roles and responsibilities. It is hoped that adoption of the ADVANCE Code of Conduct by all partners involved in a study will facilitate and speed-up its initiation, design, conduct and reporting. Adoption of the ADVANCE Code of Conduct should be stated in the study protocol, study report and publications and journal editors are encouraged to use it as an indication that good principles of public health, science and transparency were followed throughout the study. Copyright © 2017. Published by Elsevier Ltd.

[Informed Consent and the Approval by Ethics Committees of Studies Involving the Use of Atypical Antipsychotics in the Management of Delirium].

PubMed

Millán-González, Ricardo

2012-03-01

Delirium is an acute alteration of consciousness and cognition. Atypical antipsychotics (AA) have recently become a main part of its treatment. Studies in this population generate a series of ethical dilemmas concerning the voluntary participation of patients and their state of vulnerability since their mental faculties are, by definition, compromised. To assess whether studies with AA for the treatment of delirium obtained an approval by an ethics committee on human research (ECHR), if an informed consent (IC) was obtained, whether the IC was verbal or written, and who gave the approval to participate. Systematic review of Medline for studies of delirium where quetiapine and olanzapine were the main treatment, assessing the existence of an ECHR approval and implementation of an IC. 11 studies were identified (6 of quetiapine and 5 of olanzapine). 5 had an ECHR approval. Most studies examining the treatment of delirium with quetiapine or olanzapine were not subject to approval by an ECHR and most of them did not obtain an IC from the patient's legal guardian. It is essential that future studies of antipsychotics and other drugs for the treatment of delirium have the protocol approved by an ECHR and a written IC signed by the patient's legal representative, since by definition delirium is a condition that compromises superior mental processes. Copyright © 2012 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

Exercise to Counteract Loss of Bone and Muscle During Androgen Deprivation Therapy in Men with Prostate Cancer

DTIC Science & Technology

2009-08-01

finishers in the current study on age and body mass index . This will enable us to evaluate BMD and body composition changes in response to exercise in men...support from the Clinical Nutrition Research Unit (CNRU) • prepare data forms • prepare data base • train research staff Final approval of the protocol...the local IRB on 19 Feb 2008. In the past year, the consent form underwent minor changes to update standard language used by the local IRB (approved

FDA Approvals - Cancer Currents Blog

Cancer.gov

Blog posts on cancer drugs and devices approved by the Food and Drug Administration—including summaries of the evidence to support the approvals and what they mean for patients—from NCI Cancer Currents.

Effects of exercise continued until anaerobic threshold on balance performance in male basketball players.

PubMed

Erkmen, Nurtekin; Suveren, Sibel; Göktepe, Ahmet Salim

2012-06-01

The objective of the present study was to determine the effects of exercise continued until the anaerobic threshold on balance performance in basketball players. Twelve male basketball players (age = 20.92 ± 2.81 years, body height = 192.72 ± 7.61 cm, body mass = 88.09 ± 8.41 kg, training experience = 7.17 ± 3.10 years) volunteered to participate in this study. A Kinesthetic Ability Trainer (KAT 2000 stabilometer) was used to measure the balance performance. Balance tests consisted of static tests on dominant, nondominant and double leg stance. The Bruce Protocol was performed by means of a treadmill. The exercise protocol was terminated when the subject passed the anaerobic threshold. After the exercise protocol, balance measurements were immediately repeated. Statistical differences between pre and post-exercise for dominant, nondominant and double leg stance were determined by the paired samples t-test according to the results of the test of normality. The post-exercise balance score on the dominant leg was significantly higher than pre-exercise (t = -2.758, p < 0.05). No differences existed between pre- and post-exercise in the balance scores of the nondominant leg after the exercise protocol (t = 0.428, p > 0.05). A significant difference was found between pre and post-exercise balance scores in the double leg stance (t = -2.354, p < 0.05). The main finding of this study was that an incremental exercise continued until the anaerobic threshold decreased balance performance on the dominant leg in basketball players, but did not alter it in the nondominant leg.

76 FR 12213 - Agency Information Collection Activities; Extension of an Approved Information Collection Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-04

...: Household Goods Consumer Information Program Assessment Study AGENCY: Federal Motor Carrier Safety... Notice. Note that DOT posts all comments received without change to http://www.regulations.gov... your comments, please include a self-addressed, stamped envelope or post card or print the...

33 CFR 151.27 - Plan submission and approval.

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) POLLUTION VESSELS CARRYING OIL, NOXIOUS LIQUID SUBSTANCES, GARBAGE, MUNICIPAL OR COMMERCIAL WASTE, AND BALLAST WATER Implementation of MARPOL 73/78 and the Protocol on Environmental Protection to the Antarctic Treaty as it Pertains to Pollution from Ships Oil Pollution § 151.27 Plan submission and approval...

7 CFR 301.92-12 - Testing protocols.

Code of Federal Regulations, 2012 CFR

2012-01-01

.... The following methodology is approved by APHIS. (a) Optional ELISA Prescreening. An APHIS-approved ELISA may be used to prescreen plant samples to determine the presence of Phytophthora spp. (1) Negative... ELISA prescreening, no further testing is required. The nursery may be considered free of evidence of...

7 CFR 301.92-12 - Testing protocols.

Code of Federal Regulations, 2013 CFR

2013-01-01

.... The following methodology is approved by APHIS. (a) Optional ELISA Prescreening. An APHIS-approved ELISA may be used to prescreen plant samples to determine the presence of Phytophthora spp. (1) Negative... ELISA prescreening, no further testing is required. The nursery may be considered free of evidence of...

7 CFR 301.92-12 - Testing protocols.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... The following methodology is approved by APHIS. (a) Optional ELISA Prescreening. An APHIS-approved ELISA may be used to prescreen plant samples to determine the presence of Phytophthora spp. (1) Negative... ELISA prescreening, no further testing is required. The nursery may be considered free of evidence of...

7 CFR 301.92-12 - Testing protocols.

Code of Federal Regulations, 2011 CFR

2011-01-01

.... The following methodology is approved by APHIS. (a) Optional ELISA Prescreening. An APHIS-approved ELISA may be used to prescreen plant samples to determine the presence of Phytophthora spp. (1) Negative... ELISA prescreening, no further testing is required. The nursery may be considered free of evidence of...

7 CFR 301.92-12 - Testing protocols.

Code of Federal Regulations, 2014 CFR

2014-01-01

.... The following methodology is approved by APHIS. (a) Optional ELISA Prescreening. An APHIS-approved ELISA may be used to prescreen plant samples to determine the presence of Phytophthora spp. (1) Negative... ELISA prescreening, no further testing is required. The nursery may be considered free of evidence of...

33 CFR 151.27 - Plan submission and approval.

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) POLLUTION VESSELS CARRYING OIL, NOXIOUS LIQUID SUBSTANCES, GARBAGE, MUNICIPAL OR COMMERCIAL WASTE, AND BALLAST WATER Implementation of MARPOL 73/78 and the Protocol on Environmental Protection to the Antarctic Treaty as it Pertains to Pollution from Ships Oil Pollution § 151.27 Plan submission and approval...

33 CFR 151.27 - Plan submission and approval.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) POLLUTION VESSELS CARRYING OIL, NOXIOUS LIQUID SUBSTANCES, GARBAGE, MUNICIPAL OR COMMERCIAL WASTE, AND BALLAST WATER Implementation of MARPOL 73/78 and the Protocol on Environmental Protection to the Antarctic Treaty as it Pertains to Pollution from Ships Oil Pollution § 151.27 Plan submission and approval...

33 CFR 151.27 - Plan submission and approval.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) POLLUTION VESSELS CARRYING OIL, NOXIOUS LIQUID SUBSTANCES, GARBAGE, MUNICIPAL OR COMMERCIAL WASTE, AND BALLAST WATER Implementation of MARPOL 73/78 and the Protocol on Environmental Protection to the Antarctic Treaty as it Pertains to Pollution from Ships Oil Pollution § 151.27 Plan submission and approval...

33 CFR 151.27 - Plan submission and approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) POLLUTION VESSELS CARRYING OIL, NOXIOUS LIQUID SUBSTANCES, GARBAGE, MUNICIPAL OR COMMERCIAL WASTE, AND BALLAST WATER Implementation of MARPOL 73/78 and the Protocol on Environmental Protection to the Antarctic Treaty as it Pertains to Pollution from Ships Oil Pollution § 151.27 Plan submission and approval...

15 CFR 921.12 - Post site selection.

Code of Federal Regulations, 2011 CFR

2011-01-01

... NOAA approval of a proposed site, the state may submit a request for funds to develop the draft... and biological characteristics of the site approved by NOAA necessary for providing EIS information to NOAA. The state's request for these post site selection funds must be accompanied by the information...

15 CFR 921.12 - Post site selection.

Code of Federal Regulations, 2014 CFR

2014-01-01

... NOAA approval of a proposed site, the state may submit a request for funds to develop the draft... and biological characteristics of the site approved by NOAA necessary for providing EIS information to NOAA. The state's request for these post site selection funds must be accompanied by the information...

15 CFR 921.12 - Post site selection.

Code of Federal Regulations, 2013 CFR

2013-01-01

... NOAA approval of a proposed site, the state may submit a request for funds to develop the draft... and biological characteristics of the site approved by NOAA necessary for providing EIS information to NOAA. The state's request for these post site selection funds must be accompanied by the information...

15 CFR 921.12 - Post site selection.

Code of Federal Regulations, 2012 CFR

2012-01-01

... NOAA approval of a proposed site, the state may submit a request for funds to develop the draft... and biological characteristics of the site approved by NOAA necessary for providing EIS information to NOAA. The state's request for these post site selection funds must be accompanied by the information...

15 CFR 921.12 - Post site selection.

Code of Federal Regulations, 2010 CFR

2010-01-01

... NOAA approval of a proposed site, the state may submit a request for funds to develop the draft... and biological characteristics of the site approved by NOAA necessary for providing EIS information to NOAA. The state's request for these post site selection funds must be accompanied by the information...

Monitoring of approved studies: A difficult tightrope walk by Ethics Committees.

PubMed

Davis, Sanish

2018-01-01

Continuing review of studies approved by the Ethics Committees (ECs) involves review of the progress of the study, annual reports, protocol deviations/violations, serious adverse event monitoring, and on-site monitoring. International and national regulations and guidelines for continuing review state that it is an opportunity for the EC to be assured that risks to subjects are minimized and is are reasonable in relation to anticipated benefits if any to the subjects and the knowledge it will generate. There are several barriers (e.g. lack of workforce, lack of training of members for conducting onsite review, and poor infrastructure) for ECs to do ongoing review of projects approved by them. Industry is an important stakeholder for the research enterprise in India and strongly advocates that ECs should at a minimum have pragmatic standard operating procedures for continuing review/monitoring of studies initially approved. ECs which deal with larger volume of studies with well-functioning secretariat, appropriately trained EC members and funding should definitely conduct onsite review/monitoring in addition to the ongoing review.

Post-Plyometric Exercise Hypotension and Heart Rate in Normotensive Individuals: Influence of Exercise Intensity

PubMed Central

Arazi, Hamid; Asadi, Abbas; Rahimzadeh, Mehdi; Moradkhani, Amir-Hossein

2013-01-01

Purpose The purpose of this study was to compare the effects of high, moderate and low intensity plyometric exercise on the post-exercise systolic and diastolic blood pressure and heart rate responses. Methods Ten healthy normotensive men (age, 21.1±0.9 years; height, 175.8±6 cm; and body mass, 69.1±13.6 kg) volunteered to participate in this study and were evaluated for three non-consecutive days in depth jump exercise from 20-cm box (low intensity [LI]), 40-cm box (moderate intensity [MI]) and 60-cm box (high intensity [HI]) for 5 sets of 20 repetitions. After each exercise session, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured every 10 min for a period of 90 min. Results No significant differences were observed among post-exercise SBP, DBP and HR when the protocols (LI, MI and HI) were compared. The LI and HI protocols showed greater reduction in SBP at 40th-70th min of post-exercise (~9%), whereas the LI and MI protocols indicated greater reduction in DBP at 10th-50th min of post exercise (~10%). In addition, the change in the DBP for HI was not significant and the increases in the HR were similar for all intensities. Conclusion It can be concluded that a plyometric exercise (PE) can reduce SBP and DBP post-exercise and therefore we can say that PE has significant effects for reducing BP and HR or post-exercise hypotension. PMID:24799997

Acute Postexercise Time Course Responses of Hypertrophic vs. Power-Endurance Squat Exercise Protocols on Maximal and Rapid Torque of the Knee Extensors.

PubMed

Conchola, Eric C; Thiele, Ryan M; Palmer, Ty B; Smith, Doug B; Thompson, Brennan J

2015-05-01

The aim of this study was to examine the effects of a medium-intensity high-volume vs. explosive squat protocol on the postexercise time course responses of maximal and rapid strength of the knee extensors. Seventeen resistance-trained men (mean ± SD: age = 22.0 ± 2.6 years) performed maximal voluntary contractions (MVCs) of the knee extensors before and after performing a squat workout using either a low-intensity fast velocity (LIFV) (5 × 16 at 40% 1 repetition maximum) or a traditional high-intensity slow velocity (TISV) (5 × 8 at 80% 1RM) exercise protocol. For each MVC, peak torque (PT), peak rate of torque development (RTDpeak), absolute (RTDabs), and relative RTD (RTDnorm) at early (0-50 milliseconds) and late (100-200 milliseconds) phases of muscle contraction were examined at pre- (Pre) and post-exercise at 0, 7, 15, and 30 (Post0...30) minutes. There were no intensity × time interactions for any variables (p = 0.098-0.832). Peak torque was greater at Pre than Post0 and Post7 (p = 0.001-0.016) but was not greater than Post15 and Post30 (p = 0.010-0.189). RTDpeak and early absolute RTD (RTD50abs) were greater at Pre than all postexercise time phases (p = 0.001-0.050); however, later absolute RTD (RTD100-200abs) was only greater at Pre than Post0 and Post30 (p = 0.013-0.048). Early relative RTD (RTD50norm) was only higher at Pre compared with Post0 (p = 0.023), whereas no differences were observed for later relative RTD (RTD100-200norm) (p = 0.920-0.990). Low-intensity fast velocity and TISV squat protocols both yielded acute decreases in maximal and rapid strength capacities following free-weight squats, with rapid strength showing slower recovery characteristics than maximal strength.

Effect of endoscopic transpapillary biliary drainage with/without endoscopic sphincterotomy on post-endoscopic retrograde cholangiopancreatography pancreatitis in patients with biliary stricture (E-BEST): a protocol for a multicentre randomised controlled trial

PubMed Central

Kato, Shin; Kuwatani, Masaki; Sugiura, Ryo; Sano, Itsuki; Kawakubo, Kazumichi; Ono, Kota; Sakamoto, Naoya

2017-01-01

Introduction The effect of endoscopic sphincterotomy prior to endoscopic biliary stenting to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis remains to be fully elucidated. The aim of this study is to prospectively evaluate the non-inferiority of non-endoscopic sphincterotomy prior to stenting for naïve major duodenal papilla compared with endoscopic sphincterotomy prior to stenting in patients with biliary stricture. Methods and analysis We designed a multicentre randomised controlled trial, for which we will recruit 370 patients with biliary stricture requiring endoscopic biliary stenting from 26 high-volume institutions in Japan. Patients will be randomly allocated to the endoscopic sphincterotomy group or the non-endoscopic sphincterotomy group. The main outcome measure is the incidence of pancreatitis within 2 days of initial transpapillary biliary drainage. Data will be analysed on completion of the study. We will calculate the 95% confidence intervals (CIs) of the incidence of pancreatitis in each group and analyse weather the difference in both groups with 95% CIs is within the non-inferiority margin (6%) using the Wald method. Ethics and dissemination This study has been approved by the institutional review board of Hokkaido University Hospital (IRB: 016–0181). Results will be submitted for presentation at an international medical conference and published in a peer-reviewed journal. Trial registration number The University Hospital Medical Information Network ID: UMIN000025727 Pre-results. PMID:28801436

TU-G-BRA-08: BEST IN PHYSICS (JOINT IMAGING-THERAPY): Hybrid PET-MRI Imaging of Acute Radiation Induced Cardiac Toxicity

DOE Office of Scientific and Technical Information (OSTI.GOV)

El-Sherif, O; Xhaferllari, I; Gaede, S

Purpose: To identify the presence of low-dose radiation induced cardiac toxicity in a canine model using hybrid positron emission tomography (PET) and magnetic resonance imaging (MRI). Methods: Research ethics board approval was obtained for a longitudinal imaging study of 5 canines after cardiac irradiation. Animals were imaged at baseline, 1 week post cardiac irradiation, and 1 month post cardiac irradiation using a hybrid PET- MRI system (Biograph mMR, Siemens Healthcare). The imaging protocol was designed to assess acute changes in myocardial perfusion and inflammation. Myocardial perfusion imaging was performed using N13-ammonia tracer followed by a dynamic PET acquisition scan. Amore » compartmental tracer kinetic model was used for absolute perfusion quantification. Myocardial inflammation imaging was performed using F18-fluorodeoxyglucose (FDG) tracer. The standard uptake value (SUV) over a region encompassing the whole heart was used to compare FDG scans. All animals received a simulation CT scan (GE Medical Systems) for radiation treatment planning. Radiation treatment plans were created using the Pinncale3 treatment planning system (Philips Radiation Oncology Systems) and designed to resemble the typical cardiac exposure during left-sided breast cancer radiotherapy. Cardiac irradiations were performed in a single fraction using a TrueBeam linear accelerator (Varian Medical Systems). Results: The delivered dose (mean ± standard deviation) to heart was 1.8±0.2 Gy. Reductions in myocardial stress perfusion relative to baseline were observed in 2 of the 5 animals 1 month post radiation. A global inflammatory response 1 month post radiation was observed in 4 of the 5 animals. The calculated SUV at 1 month post radiation was significantly higher (p=0.05) than the baseline SUV. Conclusion: Low doses of cardiac irradiation (< 2 Gy) may lead to myocardial perfusion defects and a global inflammatory response that can be detectable as early as 1 month post irradiation using hybrid PET-MRI imaging techniques.« less

A post-gene silencing bioinformatics protocol for plant-defence gene validation and underlying process identification: case study of the Arabidopsis thaliana NPR1.

PubMed

Yocgo, Rosita E; Geza, Ephifania; Chimusa, Emile R; Mazandu, Gaston K

2017-11-23

Advances in forward and reverse genetic techniques have enabled the discovery and identification of several plant defence genes based on quantifiable disease phenotypes in mutant populations. Existing models for testing the effect of gene inactivation or genes causing these phenotypes do not take into account eventual uncertainty of these datasets and potential noise inherent in the biological experiment used, which may mask downstream analysis and limit the use of these datasets. Moreover, elucidating biological mechanisms driving the induced disease resistance and influencing these observable disease phenotypes has never been systematically tackled, eliciting the need for an efficient model to characterize completely the gene target under consideration. We developed a post-gene silencing bioinformatics (post-GSB) protocol which accounts for potential biases related to the disease phenotype datasets in assessing the contribution of the gene target to the plant defence response. The post-GSB protocol uses Gene Ontology semantic similarity and pathway dataset to generate enriched process regulatory network based on the functional degeneracy of the plant proteome to help understand the induced plant defence response. We applied this protocol to investigate the effect of the NPR1 gene silencing to changes in Arabidopsis thaliana plants following Pseudomonas syringae pathovar tomato strain DC3000 infection. Results indicated that the presence of a functionally active NPR1 reduced the plant's susceptibility to the infection, with about 99% of variability in Pseudomonas spore growth between npr1 mutant and wild-type samples. Moreover, the post-GSB protocol has revealed the coordinate action of target-associated genes and pathways through an enriched process regulatory network, summarizing the potential target-based induced disease resistance mechanism. This protocol can improve the characterization of the gene target and, potentially, elucidate induced defence response by more effectively utilizing available phenotype information and plant proteome functional knowledge.

75 FR 11540 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-11

... the evaluation: (1) Pre/post-test interview protocol--Consisting of both open- and closed-ended... respondents in interviews that will take one hour each. The pre/post-test interview protocol will be... the year. At the end of the year, post-test interviews will be performed as one-hour group interviews...

Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research.

PubMed

Gilbert, Amy Lewis; Knopf, Amelia S; Fortenberry, J Dennis; Hosek, Sybil G; Kapogiannis, Bill G; Zimet, Gregory D

2015-07-01

The Adolescent Medicine Trials Network Protocol 113 (ATN113) is an open-label, multisite demonstration project and Phase II safety study of human immunodeficiency virus (HIV) preexposure prophylaxis with 15- to 17-year-old young men who have sex with men that requires adolescent consent for participation. The purpose of this study was to examine factors related to the process by which Institutional Review Boards (IRBs) and researchers made decisions regarding whether to approve and implement ATN113 so as to inform future biomedical HIV prevention research with high-risk adolescent populations. Participants included 17 researchers at 13 sites in 12 states considering ATN113 implementation. Qualitative descriptive methods were used. Data sources included interviews and documents generated during the initiation process. A common process for initiating ATN113 emerged, and informants described how they identified and addressed practical, ethical, and legal challenges that arose. Informants described the process as responding to the protocol, preparing for IRB submission, abstaining from or proceeding with submission, responding to IRB concerns, and reacting to the outcomes. A complex array of factors impacting approval and implementation were identified, and ATN113 was ultimately implemented in seven of 13 sites. Informants also reflected on lessons learned that may help inform future biomedical HIV prevention research with high-risk adolescent populations. The results illustrate factors for consideration in determining whether to implement such trials, demonstrate that such protocols have the potential to be approved, and highlight a need for clearer standards regarding biomedical HIV prevention research with high-risk adolescent populations. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Salivary cortisol and testosterone responses to resistance and plyometric exercise in 12- to 14-year-old boys.

PubMed

Klentrou, Panagiota; Giannopoulou, Angeliki; McKinlay, Brandon J; Wallace, Phillip; Muir, Cameron; Falk, Bareket; Mack, Diane

2016-07-01

This study examined changes in salivary testosterone and cortisol following resistance and plyometric exercise protocols in active boys. In a crossover experimental design, 26 peri-pubertal (12- to 14-year-old) soccer players performed 2 exercise trials in random order, on separate evenings, 1 week apart. Each trial included a 30 min control session followed by 30 min of either resistance or plyometric exercise. Saliva was collected at baseline, post-control (i.e., pre-exercise), and 5 and 30 min post-exercise. There were no significant differences in the baseline hormone concentrations between trials or between weeks (p > 0.05). A significant effect for time was found for testosterone (p = 0.02, [Formula: see text] = 0.14), which increased from pre-exercise to 5 min post-exercise in both the resistance (27% ± 5%) and plyometric (12% ± 6%) protocols. Cortisol decreased to a similar extent in both trials (p = 0.009, [Formula: see text] = 0.19) from baseline to post-control and then to 5 min post-exercise, following its typical circadian decrease in the evening hours. However, a significant protocol-by-time interaction was observed for cortisol, which increased 30 min after the plyometrics (+31% ± 12%) but continued to decrease following the resistance protocol (-21% ± 5%). Our results suggest that in young male athletes, multiple modes of exercise can lead to a transient anabolic state, thus maximizing the beneficial effects on growth and development, when exercise is performed in the evening hours.

50 CFR 15.26 - Approval of cooperative breeding programs.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 50 Wildlife and Fisheries 1 2014-10-01 2014-10-01 false Approval of cooperative breeding programs. 15.26 Section 15.26 Wildlife and Fisheries UNITED STATES FISH AND WILDLIFE SERVICE, DEPARTMENT OF THE... program requested for the exotic bird species, including: (i) A breeding protocol, including a genetic...

50 CFR 15.26 - Approval of cooperative breeding programs.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 50 Wildlife and Fisheries 1 2013-10-01 2013-10-01 false Approval of cooperative breeding programs. 15.26 Section 15.26 Wildlife and Fisheries UNITED STATES FISH AND WILDLIFE SERVICE, DEPARTMENT OF THE... program requested for the exotic bird species, including: (i) A breeding protocol, including a genetic...

50 CFR 15.26 - Approval of cooperative breeding programs.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 50 Wildlife and Fisheries 1 2012-10-01 2012-10-01 false Approval of cooperative breeding programs. 15.26 Section 15.26 Wildlife and Fisheries UNITED STATES FISH AND WILDLIFE SERVICE, DEPARTMENT OF THE... program requested for the exotic bird species, including: (i) A breeding protocol, including a genetic...

Electroacupuncture prevents endothelial dysfunction induced by ischemia-reperfusion injury via a cyclooxygenase-2-dependent mechanism: A randomized controlled crossover trial

PubMed Central

Park, Jimin; Woo, Jong Shin; Leem, Jungtae; Park, Jun Hyeong; Lee, Sanghoon; Chung, Hyemoon; Lee, Jung Myung; Kim, Jin-Bae; Kim, Woo-Shik; Kim, Kwon Sam; Kim, Weon

2017-01-01

Objective Exploring clinically effective methods to reduce ischemia-reperfusion (IR) injury in humans is critical. Several drugs have shown protective effects, but studies using other interventions have been rare. Electroacupuncture (EA) has induced similar protection in several animal studies but no study has investigated how the effects could be translated and reproduced in humans. This study aimed to explore the potential effect and mechanisms of EA in IR-induced endothelial dysfunction in humans. Methods This is a prospective, randomized, crossover, sham-controlled trial consisting of two protocols. Protocol 1 was a crossover study to investigate the effect of EA on IR-induced endothelial dysfunction. Twenty healthy volunteers were randomly assigned to EA or sham EA (sham). Flow mediated dilation (FMD) of the brachial artery (BA), nitroglycerin-mediated endothelial independent dilation, blood pressure before and after IR were measured. In protocol 2, seven volunteers were administered COX-2 inhibitor celecoxib (200 mg orally twice daily) for five days. After consumption, volunteers underwent FMD before and after IR identical to protocol 1. Results In protocol 1, baseline BA diameter, Pre-IR BA diameter and FMD were similar between the two groups (p = NS). After IR, sham group showed significantly blunted FMD (Pre-IR: 11.41 ± 3.10%, Post-IR: 4.49 ± 2.04%, p < 0.001). However, EA protected this blunted FMD (Pre-IR: 10.96 ± 5.30%, Post-IR: 9.47 ± 5.23%, p = NS, p < 0.05 compared with sham EA after IR). In protocol 2, this protective effect was completely abolished by pre-treatment with celecoxib (Pre-IR: 11.05 ± 3.27%; Post-IR: 4.20 ± 1.68%, p = 0.001). Conclusion EA may prevent IR-induced endothelial dysfunction via a COX-2 dependent mechanism. PMID:28591155

[Independent ethics committees for clinical research in Argentina. An evaluation and a system to guarantee their independence].

PubMed

Gonorazky, Sergio E

2008-01-01

The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT) requires that an independent ethics committee of sponsors and/or researchers must previously evaluate and approve all the new pharmacological research protocols carried out on human beings. However, due to the lucrative nature of the evaluation, and because the selection of the Independent Ethics Committee is carried out by the sponsors and/or researchers, the assumed autonomy of the former can be reduced to merely a relationship of "service provider-customer". The Institutional Review Board of the Mar del Plata s Community Hospital has evaluated, between 2005 and 2006, thirty three research protocols (with their corresponding information sheets for patients and informed consent forms) previously approved by a non-institutional Independent Ethics Committee. The median number of objections made by the Institutional Review Board, which prompted the previously mentioned protocols to be modified in order to be approved, was of three per protocol. In other words, the accreditation of an Independent Ethics Committee requires a system that guarantees actual independence from the sponsors and/or researchers, as well as management control mechanisms that may lead them into an eventual loss of accreditation. Several measures are proposed in order to correct the deficiencies of the present system.

Influence of irrigation protocols on the bond strength of fiber posts cemented with a self-adhesive luting agent 24 hours after endodontic treatment.

PubMed

Lima, Jessica Ferraz Carvalho; Lima, Adriano Fonseca; Humel, Maria Malerba Colombi; Paulillo, Luis Alexandre Maffei Sartini; Marchi, Giselle Maria; Ferraz, Caio Cezar Randi

2015-01-01

The aim of this in vitro study was to evaluate the influence of different irrigation protocols on the bond strength, at different root depths, of fiber posts cemented with a self-adhesive cement 24 hours after endodontic treatment. Fifty-six bovine incisor roots were endodontically prepared and separated into 7 groups (n = 8) according to irrigation protocols: group 1, sterile saline (control); group 2, chlorhexidine (CHX) gel 2% and saline; group 3, sodium hypochlorite (NaOCl) 5.25% and saline; group 4, CHX and saline (final irrigation with ethylenediaminetetraacetic acid [EDTA] 17%); group 5, NaOCl and saline (final irrigation with EDTA); group 6, CHX and saline (final irrigation with NaOCl and EDTA); and group 7, NaOCl (final irrigation with CHX and EDTA). No statistically significant difference was found among the groups. Within the limitations of this study, it can be concluded that the different irrigation protocols did not influence the bond strength of self-adhesive resin cement, which presented similar behaviors at the 3 root depths studied.

Building a Protocol Expressway: The Case of Mayo Clinic Cancer Center

PubMed Central

McJoynt, Terre A.; Hirzallah, Muhanad A.; Satele, Daniel V.; Pitzen, Jason H.; Alberts, Steven R.; Rajkumar, S. Vincent

2009-01-01

Purpose Inconsistencies and errors resulting from nonstandard processes, together with redundancies, rework, and excess workload, lead to extended time frames for clinical trial protocol development. This results in dissatisfaction among sponsors, investigators, and staff and restricts the availability of novel treatment options for patients. Methods A team of experts from Mayo Clinic formed, including Protocol Development Unit staff and management from the three Mayo Clinic campuses (Florida, Minnesota, and Arizona), a systems and procedures analyst, a quality office analyst, and two physician members to address the identified deficiencies. The current-state process was intensively reviewed, and improvement steps were taken to accelerate the development and approval of cancer-related clinical trials. The primary goal was to decrease the time from receipt of a new protocol through submission to an approving authority, such as the National Cancer Institute or institutional review board. Results Using the Define, Measure, Analyze, Improve, Control (DMAIC) framework infused with Lean waste-reduction methodologies, areas were identified for improvement, including enhancing first-time quality and processing new studies on a first-in/first-out basis. The project was successful in improving the mean turnaround time for internally authored protocols (P < .001) from 25.00 weeks (n = 41; range, 3.43 to 94.14 weeks) to 10.15 weeks (n = 14; range, 4.00 to 22.14 weeks). The mean turnaround time for externally authored protocols was improved (P < .001) from 20.61 weeks (n = 85; range, 3.29 to 108.57 weeks) to 7.79 weeks (n = 50; range, 2.00 to 20.86 weeks). Conclusion DMAIC framework combined with Lean methodologies is an effective tool to structure the definition, planning, analysis, and implementation of significant process changes. PMID:19564529

Building a protocol expressway: the case of Mayo Clinic Cancer Center.

PubMed

McJoynt, Terre A; Hirzallah, Muhanad A; Satele, Daniel V; Pitzen, Jason H; Alberts, Steven R; Rajkumar, S Vincent

2009-08-10

Inconsistencies and errors resulting from nonstandard processes, together with redundancies, rework, and excess workload, lead to extended time frames for clinical trial protocol development. This results in dissatisfaction among sponsors, investigators, and staff and restricts the availability of novel treatment options for patients. A team of experts from Mayo Clinic formed, including Protocol Development Unit staff and management from the three Mayo Clinic campuses (Florida, Minnesota, and Arizona), a systems and procedures analyst, a quality office analyst, and two physician members to address the identified deficiencies. The current-state process was intensively reviewed, and improvement steps were taken to accelerate the development and approval of cancer-related clinical trials. The primary goal was to decrease the time from receipt of a new protocol through submission to an approving authority, such as the National Cancer Institute or institutional review board. Using the Define, Measure, Analyze, Improve, Control (DMAIC) framework infused with Lean waste-reduction methodologies, areas were identified for improvement, including enhancing first-time quality and processing new studies on a first-in/first-out basis. The project was successful in improving the mean turnaround time for internally authored protocols (P < .001) from 25.00 weeks (n = 41; range, 3.43 to 94.14 weeks) to 10.15 weeks (n = 14; range, 4.00 to 22.14 weeks). The mean turnaround time for externally authored protocols was improved (P < .001) from 20.61 weeks (n = 85; range, 3.29 to 108.57 weeks) to 7.79 weeks (n = 50; range, 2.00 to 20.86 weeks). DMAIC framework combined with Lean methodologies is an effective tool to structure the definition, planning, analysis, and implementation of significant process changes.

77 FR 22387 - Pipeline Safety: Information Collection Activities, Revision to Gas Transmission and Gathering...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-13

... post- construction hydrostatic test of at least 1.25 times the maximum allowable operating pressure... a post-construction hydrostatic pressure test of at least 125% of the MAOP, and total miles of... approved under OMB control number 2137- 0522 and the hazardous liquid accident report is approved under OMB...

30 CFR 7.91 - Post-approval product audit.

Code of Federal Regulations, 2014 CFR

2014-07-01

... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in... except for cause, the approval holder shall make a diesel engine available for audit at no cost to MSHA. ...

30 CFR 7.91 - Post-approval product audit.

Code of Federal Regulations, 2011 CFR

2011-07-01

... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in... except for cause, the approval holder shall make a diesel engine available for audit at no cost to MSHA. ...

30 CFR 7.91 - Post-approval product audit.

Code of Federal Regulations, 2010 CFR

2010-07-01

... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in... except for cause, the approval holder shall make a diesel engine available for audit at no cost to MSHA. ...

30 CFR 7.91 - Post-approval product audit.

Code of Federal Regulations, 2012 CFR

2012-07-01

... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in... except for cause, the approval holder shall make a diesel engine available for audit at no cost to MSHA. ...

30 CFR 7.91 - Post-approval product audit.

Code of Federal Regulations, 2013 CFR

2013-07-01

... APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines Intended for Use in... except for cause, the approval holder shall make a diesel engine available for audit at no cost to MSHA. ...

The effects of the prevention program 'New Perspectives' (NP) on juvenile delinquency and other life domains: study protocol for a randomized controlled trial.

PubMed

de Vries, Sanne L A; Hoeve, Machteld; Asscher, Jessica J; Stams, Geert Jan Jm

2014-01-01

New Perspectives (NP) is a prevention program aiming to prevent that youth at onset of a criminal career will develop a persistent criminal behaviour pattern. The effects of NP on juvenile delinquency and other life domains are investigated, using a randomized controlled trial (RCT). In the present study at-risk youth aged 12 to 23 years are assigned randomly to the intervention (N = 90, NP) or control condition consisting of care as usual (N = 90, CAU). After screening, random assignment, and consent to participate, adolescents and their parents are requested to complete questionnaires. Data are collected at four points in time: at baseline (before the start of the intervention), after 3 months, after 6 months (post-test) and 1 year after treatment (follow-up). Primary outcome measures include involvement in delinquent behaviour and recidivism. Secondary outcome measures include parenting behaviour, life events, prosocial behaviour, deviant and prosocial peers, externalizing behaviour, cognitive distortions, moral reasoning, self-worth, anxiety, depression, client satisfaction, therapeutic alliance and motivation. Standardized questionnaires and interviews are used to collect data. Moderator analyses will also be conducted in order to examine the influence of ethnic background, gender and age on the program effectiveness. The present study will provide new insights in the effects of a prevention program targeting youth at risk for the development of a persistent criminal career. Dutch trial register number NTR4370. The study is financially supported by a grant from ZonMw, the Dutch Organization for Health research and Development, grant number 157004006. The study is approved by the Ethics Committee of the University of Amsterdam, approval number 2011-CDE-01.

Integrative Lifecourse and Genetic Analysis of Military Working Dogs

DTIC Science & Technology

2013-10-01

Working Dogs 5a. CONTRACT NUMBER 5b. GRANT NUMBER W81XWH-11-2-0225 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) C. Guillermo Couto, DVM, Diplomate...protocol for the collection of biological samples and Lackland veterinary approval was granted ; and final Lackland AFB oversight approval was granted and...those documents were submitted to DoD CDMRP grant administration. Currently, there is one final approval from ACURO pending (and expected

From QASC to QASCIP: successful Australian translational scale-up and spread of a proven intervention in acute stroke using a prospective pre-test/post-test study design.

PubMed

Middleton, Sandy; Lydtin, Anna; Comerford, Daniel; Cadilhac, Dominique A; McElduff, Patrick; Dale, Simeon; Hill, Kelvin; Longworth, Mark; Ward, Jeanette; Cheung, N Wah; D'Este, Cate

2016-05-06

To embed an evidence-based intervention to manage FEver, hyperglycaemia (Sugar) and Swallowing (the FeSS protocols) in stroke, previously demonstrated in the Quality in Acute Stroke Care (QASC) trial to decrease 90-day death and dependency, into all stroke services in New South Wales (NSW), Australia's most populous state. Pre-test/post-test prospective study. 36 NSW stroke services. Our clinical translational initiative, the QASC Implementation Project (QASCIP), targeted stroke services to embed 3 nurse-led clinical protocols (the FeSS protocols) into routine practice. Clinical champions attended a 1-day multidisciplinary training workshop and received standardised educational resources and ongoing support. Using the National Stroke Foundation audit collection tool and processes, patient data from retrospective medical record self-reported audits for 40 consecutive patients with stroke per site pre-QASCIP (1 July 2012 to 31 December 2012) were compared with prospective self-reported data from 40 consecutive patients with stroke per site post-QASCIP (1 November 2013 to 28 February 2014). Inter-rater reliability was substantial for 10 of 12 variables. Proportion of patients receiving care according to the FeSS protocols pre-QASCIP to post-QASCIP. All 36 (100%) NSW stroke services participated, nominating 100 site champions who attended our educational workshops. The time from start of intervention to completion of post-QASCIP data collection was 8 months. All (n=36, 100%) sites provided medical record audit data for 2144 patients (n=1062 pre-QASCIP; n=1082 post-QASCIP). Pre-QASCIP to post-QASCIP, proportions of patients receiving the 3 targeted clinical behaviours increased significantly: management of fever (pre: 69%; post: 78%; p=0.003), hyperglycaemia (pre: 23%; post: 34%; p=0.0085) and swallowing (pre: 42%; post: 51%; p=0.033). We obtained unprecedented statewide scale-up and spread to all NSW stroke services of a nurse-led intervention previously proven to improve long-term patient outcomes. As clinical leaders search for strategies to improve quality of care, our initiative is replicable and feasible in other acute care settings. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Comparison of Clobetasol Propionate Generics Using Simplified in Vitro Bioequivalence Method for Topical Drug Products.

PubMed

Soares, Kelen Carine Costa; de Souza, Weidson Carlos; de Souza Texeira, Leonardo; da Cunha-Filho, Marcilio Sergio Soares; Gelfuso, Guilherme Martins; Gratieri, Tais

2017-11-20

The aim of this paper is to propose a simple in vitro skin penetration experiment in which the drug is extracted from the whole skin piece as a test valid for formulation screening and optimization during development process, equivalence assessment during quality control or post-approval after changes to the product. Twelve clobetasol propionate (CP) formulations (six creams and six ointments) from the local market were used as a model to challenge the proposed methodology in comparison to in vitro skin penetration following tape-stripping for drug extraction. To support the results, physicochemical tests for pH, viscosity, density and assay, as well as in vitro release were performed. Both protocols, extracting the drug from the skin using the tape-stripping technique or extracting from the full skin were capable of differentiating CP formulations. Only one formulation did not present statistical difference from the reference drug product in penetration tests and only other two oitments presented equivalent release to the reference. The proposed protocol is straightforward and reproducible. Results suggest the bioinequavalence of tested CP formulations reinforcing the necessity of such evaluations. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Quantum-key-distribution protocol with pseudorandom bases

NASA Astrophysics Data System (ADS)

Trushechkin, A. S.; Tregubov, P. A.; Kiktenko, E. O.; Kurochkin, Y. V.; Fedorov, A. K.

2018-01-01

Quantum key distribution (QKD) offers a way for establishing information-theoretical secure communications. An important part of QKD technology is a high-quality random number generator for the quantum-state preparation and for post-processing procedures. In this work, we consider a class of prepare-and-measure QKD protocols, utilizing additional pseudorandomness in the preparation of quantum states. We study one of such protocols and analyze its security against the intercept-resend attack. We demonstrate that, for single-photon sources, the considered protocol gives better secret key rates than the BB84 and the asymmetric BB84 protocols. However, the protocol strongly requires single-photon sources.

A comparison of two treatments for childhood apraxia of speech: methods and treatment protocol for a parallel group randomised control trial

PubMed Central

2012-01-01

Background Childhood Apraxia of Speech is an impairment of speech motor planning that manifests as difficulty producing the sounds (articulation) and melody (prosody) of speech. These difficulties may persist through life and are detrimental to academic, social, and vocational development. A number of published single subject and case series studies of speech treatments are available. There are currently no randomised control trials or other well designed group trials available to guide clinical practice. Methods/Design A parallel group, fixed size randomised control trial will be conducted in Sydney, Australia to determine the efficacy of two treatments for Childhood Apraxia of Speech: 1) Rapid Syllable Transition Treatment and the 2) Nuffield Dyspraxia Programme – Third edition. Eligible children will be English speaking, aged 4–12 years with a diagnosis of suspected CAS, normal or adjusted hearing and vision, and no comprehension difficulties or other developmental diagnoses. At least 20 children will be randomised to receive one of the two treatments in parallel. Treatments will be delivered by trained and supervised speech pathology clinicians using operationalised manuals. Treatment will be administered in 1-hour sessions, 4 times per week for 3 weeks. The primary outcomes are speech sound and prosodic accuracy on a customised 292 item probe and the Diagnostic Evaluation of Articulation and Phonology inconsistency subtest administered prior to treatment and 1 week, 1 month and 4 months post-treatment. All post assessments will be completed by blinded assessors. Our hypotheses are: 1) treatment effects at 1 week post will be similar for both treatments, 2) maintenance of treatment effects at 1 and 4 months post will be greater for Rapid Syllable Transition Treatment than Nuffield Dyspraxia Programme treatment, and 3) generalisation of treatment effects to untrained related speech behaviours will be greater for Rapid Syllable Transition Treatment than Nuffield Dyspraxia Programme treatment. This protocol was approved by the Human Research Ethics Committee, University of Sydney (#12924). Discussion This will be the first randomised control trial to test treatment for CAS. It will be valuable for clinical decision-making and providing evidence-based services for children with CAS. Trial Registration Australian New Zealand Clinical Trials Registry: ACTRN12612000744853 PMID:22863021

A semi-nested real-time PCR method to detect low chimerism percentage in small quantity of hematopoietic stem cell transplant DNA samples.

PubMed

Aloisio, Michelangelo; Bortot, Barbara; Gandin, Ilaria; Severini, Giovanni Maria; Athanasakis, Emmanouil

2017-02-01

Chimerism status evaluation of post-allogeneic hematopoietic stem cell transplantation samples is essential to predict post-transplant relapse. The most commonly used technique capable of detecting small increments of chimerism is quantitative real-time PCR. Although this method is already used in several laboratories, previously described protocols often lack sensitivity and the amount of the DNA required for each chimerism analysis is too high. In the present study, we compared a novel semi-nested allele-specific real-time PCR (sNAS-qPCR) protocol with our in-house standard allele-specific real-time PCR (gAS-qPCR) protocol. We selected two genetic markers and analyzed technical parameters (slope, y-intercept, R2, and standard deviation) useful to determine the performances of the two protocols. The sNAS-qPCR protocol showed better sensitivity and precision. Moreover, the sNAS-qPCR protocol requires, as input, only 10 ng of DNA, which is at least 10-fold less than the gAS-qPCR protocols described in the literature. Finally, the proposed sNAS-qPCR protocol could prove very useful for performing chimerism analysis with a small amount of DNA, as in the case of blood cell subsets.

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

PubMed Central

Husebø, Sissel Eikeland; Olsen, Øystein Evjen

2016-01-01

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

A Randomized Clinical Trial of Cognitive-Behavioral Treatment for PTSD in Women

DTIC Science & Technology

2003-10-01

Post Traumatic Stress Disorder ( PTSD ) in 384 female veterans and active duty personnel at 11 sites. This is a VA Cooperative Study. Walter...14. SUBJECT TERMS 15. NUMBER OF PAGES Post - Traumatic Stress Disorder 6 16. PRICE CODE 17. SECURITY CLASSIFICATION 18. SECURITY CLASSIFICATION 19...Clinical Trial of Cognitive-Behavioral Treatment for Post Traumatic Stress Disorder in Women for this study, from the protocol Additionally, a new

ALT-114 and ALT-118 Alternative Approaches to NIST-Traceable Reference Gases

EPA Science Inventory

In 2016, US EPA approved two separate alternatives (ALT 114 and ALT 118) for the preparation and certification of Hydrogen Chloride (HCl) and Mercury (Hg) cylinder reference gas standards that can serve as EPA Protocol gases where EPA Protocol are required, but unavailable. The a...

76 FR 65721 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-24

... Stratospheric Ozone Protection regulations, the science of ozone layer depletion, and related topics... Layer (Protocol) and the CAA. Entities applying for this exemption are asked to submit to EPA... Substances that Deplete the Ozone Layer (Protocol). The information collection request is required to obtain...

The cumulative effect of multiple critical care protocols on length of stay in a geriatric trauma population.

PubMed

Frederickson, Tiffany A; Renner, Catherine Hackett; Swegle, James R; Sahr, Sheryl M

2013-01-01

The elderly individuals are the most rapidly growing cohort within the US population, and a corresponding increase is being seen in elderly trauma patients. Elderly patients are more likely to have a hospital length of stay (LOS) in excess of 10 days. They account for 60% of total ICU days. Length of stay is frequently used as a proxy measure for improvement in injury outcomes, changes in quality of care, and hospital outcomes. Patient care protocols are typically created from evidence-based guidelines that serve to reduce variation in care from patient to patient. Patient care protocols have been found to positively impact patient care with reduced duration of mechanical ventilation, shorter LOS in the ICU and shorter overall hospitalization time, reduced mortality, and reduced health care costs. The following study was designed to assess the impact of the implementation of 4 patient care protocols within an elderly trauma population. We hypothesized that the implementation of these protocols would have a beneficial impact on patient care that could be measured by a decrease in hospital LOS. An archival, retrospective pretest/posttest study was performed on elderly trauma patients. The new protocols helped guide practical changes in care that resulted in a 32% decrease in LOS for our elderly trauma patients which exceeds the 25% decrease found in other studies. Additionally, the "Other" category for each variable was less frequently used in the post-protocol phase than in the pre-protocol phase, suggesting a spillover effect on the level of detail recorded in the patient chart. With less variation in practices in the post-protocol phase, Injury Severity score, and admission systolic blood pressure emerged as significant predictors of LOS.

Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28-29 January 2014).

PubMed

Cook, Graham; France, Georges; Holte, Øyvind; Lorenti, Giampiero; Tainsh, David

2016-01-01

This paper summarizes the discussions and insights gained from the key themes that emerged during the Quality by Design (QbD) Workshop held at the European Medicines Agency (EMA) offices in London, UK, on 28-29 January 2014. Industry and regulators shared practical experiences from six case studies (five approved small molecule products and one phase 3 biotechnological product) based on QbD submissions by five companies (AstraZeneca, GlaxoSmithKline, Novartis, NovoNordisk, and Pfizer).The case studies covered a range of different development, regulatory submission, and post-approval aspects of QbD and were developed through confidential discussions between the company representatives and regulators. Key themes that emerged from the workshop discussions were: 1. presentation of information in submissions (development story and the presentation of information in marketing authorization applications; risk assessment and criticality); 2. development aspects (design space; use of models; control strategy); and 3. post-approval aspects (lifecycle management; dossier-quality system interactions; handling of deviations). Many aspects of QbD for biotechnological products are similar to small molecules, but there are some important differences highlighted in this paper.The final section of the paper discusses some proposals for future developments to address the issues that were identified. This paper summarizes the discussions and insights gained from the key themes that emerged during the Quality by Design (QbD) Workshop held at the European Medicines Agency offices in London, UK, on 28-29 January 2014. Industry and regulators shared practical experiences from six case studies (five approved small-molecule products and one phase 3 biotechnological product) based on QbD submissions by five companies (AstraZeneca, GlaxoSmithKline, Novartis, NovoNordisk, and Pfizer).The case studies covered a range of different development, regulatory submission, and post-approval aspects of QbD and were developed through confidential discussions between the company representatives and regulators. Key themes that emerged from the workshop discussions were: 1. presentation of information in submissions (development story and the presentation of information in marketing authorization applications; risk assessment and criticality); 2. development aspects (design space; use of models; control strategy); and 3. post-approval aspects (lifecycle management; dossier-quality system interactions; handling of deviations). Many aspects of QbD for biotechnological products are similar to small molecules, but there are some important differences highlighted in this paper.The final section of the paper discusses some proposals for future developments to address the issues that were identified. © PDA, Inc. 2016.

Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory.

PubMed

Hróbjartsson, Asbjørn; Pildal, Julie; Chan, An-Wen; Haahr, Mette T; Altman, Douglas G; Gøtzsche, Peter C

2009-09-01

To compare the reporting on blinding in protocols and articles describing randomized controlled trials. We studied 73 protocols of trials approved by the scientific/ethical committees for Copenhagen and Frederiksberg, 1994 and 1995, and their corresponding publications. Three out of 73 trials (4%) reported blinding in the protocol that contradicted that in the publication (e.g., "open" vs. "double blind"). The proportion of "double-blind" trials with a clear description of the blinding of participants increased from 11 out of 58 (19%) when based on publications alone to 39 (67%) when adding the information in the protocol. The similar proportions for the blinding of health care providers were 2 (3%) and 22 (38%); and for the blinding of data collectors, they were 8 (14%) and 14 (24%). In 52 of 58 publications (90%), it was unclear whether all patients, health care providers, and data collectors had been blinded. In 4 of the 52 trials (7%), the protocols clarified that all three key trial persons had been blinded. The reporting on blinding in both trial protocols and publications is often inadequate. We suggest developing international guidelines for the reporting of trial protocols and public access to protocols.

Reducing distress and improving social functioning in daily life in people with auditory verbal hallucinations: study protocol for the ‘Temstem’ randomised controlled trial

PubMed Central

Scheffers, Dorien; Tromp, Nynke; Nuij, Chani; Delespaul, Philippe; Riper, Heleen; van der Gaag, Mark; van den Berg, David

2018-01-01

Introduction Auditory verbal hallucinations (AVH) are prevalent experiences that can induce distress and impede social functioning. While most voice hearers benefit from antipsychotic medication or cognitive–behavioural therapy, additional effective interventions are needed to reduce the burden of experiencing AVH. ‘Temstem’ is an easily accessible and useable smartphone application that was developed by designers in close cooperation with voice hearers and experts. By using language games, Temstem aims to reduce distress and improve social functioning. Methods This is a single-blind multicentre randomised controlled trial with two arms: ‘Temstem+AVH monitoring’ versus ‘AVH monitoring’ (total n=100). Participants are adult patients who suffer daily from AVH and will be recruited in outpatient units. Primary assessment in daily life is made by the Experience Sampling Method (ESM) and daily monitoring with the PsyMate app. During an ESM period of 6 days, participants assess their mental state (including AVH and context) several times a day by filling in short questionnaires. There are three 6-day ESM periods: at baseline (week 0–1), post-treatment (weeks 5–6) and follow-up (weeks 9–10). In addition, during the entire 10-week study period, all participants monitor their AVH two times a day with a short assessment via the PsyMate app. Participants in the Temstem+AVH monitoring condition are provided with the Temstem app from week 1 to 6. Other assessments made at baseline, post-treatment and follow-up are based on questionnaires and a clinical interview. Ethics and dissemination The results from this study will provide an evaluation of the effectiveness of Temstem, a non-invasive and easily accessible app for voice hearers, and insight into the determinants of optimal use. Results will be disseminated unreservedly, irrespective of the magnitude or direction of the effects. This study protocol was approved by the Medical Ethics Committee of the VU University Medical Centre (METC number: 2015.435/NL53684.029.15). Trial registration number ISRCTN75717636; Pre-results. PMID:29511020

A new quantum sealed-bid auction protocol with secret order in post-confirmation

NASA Astrophysics Data System (ADS)

Wang, Jing-Tao; Chen, Xiu-Bo; Xu, Gang; Meng, Xiang-Hua; Yang, Yi-Xian

2015-10-01

A new security protocol for quantum sealed-bid auction is proposed to resist the collusion attack from some malicious bidders. The most significant feature of this protocol is that bidders prepare their particles with secret order in post-confirmation for encoding bids. In addition, a new theorem and its proof are given based on the theory of combinatorial mathematics, which can be used as evaluation criteria for the collusion attack. It is shown that the new protocol is immune to the collusion attack and meets the demand for a secure auction. Compared with those previous protocols, the security, efficiency and availability of the proposed protocol are largely improved.

30 CFR 250.282 - Do I have to conduct post-approval monitoring?

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 2 2012-07-01 2012-07-01 false Do I have to conduct post-approval monitoring... OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and... monitoring? The Regional Supervisor may direct you to conduct monitoring programs. You must retain copies of...

30 CFR 250.282 - Do I have to conduct post-approval monitoring?

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 2 2013-07-01 2013-07-01 false Do I have to conduct post-approval monitoring... OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and... monitoring? The Regional Supervisor may direct you to conduct monitoring programs. You must retain copies of...

30 CFR 250.282 - Do I have to conduct post-approval monitoring?

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 2 2014-07-01 2014-07-01 false Do I have to conduct post-approval monitoring... OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Plans and... monitoring? The Regional Supervisor may direct you to conduct monitoring programs. You must retain copies of...

Cervical Spondylotic Myelopathy Surgical (CSM-S) Trial: Randomized Controlled Trial Design and Rationale

PubMed Central

Ghogawala, Zoher; Benzel, Edward C.; Heary, Robert F.; Riew, K. Daniel; Albert, Todd J.; Butler, William E.; Barker, Fred G.; Heller, John G.; McCormick, Paul C.; Whitmore, Robert G.; Freund, Karen M.; Schwartz, J. Sanford

2014-01-01

Background Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There is significant practice variation and uncertainty as to the optimal surgical approach for treating CSM. Objective The primary objective is to determine if ventral surgery is associated with superior SF-36 Physical Component Summary (PCS) outcome at one year follow-up compared to dorsal (laminectomy/fusion or laminoplasty) surgery for the treatment of CSM. The study will also investigate whether post-operative sagittal balance is an independent predictor of overall outcome and will compare health resource utilization for ventral and dorsal procedures. Methods The study is a randomized, controlled trial with a nonrandomized arm for patients who are eligible but decline randomization. Two hundred fifty patients (159 randomized) with CSM from 11 sites will be recruited over 18 months. The primary outcome is the Short Form-36 PCS score. Secondary outcomes include disease specific outcomes, overall health-related quality of life (EuroQol-5D), and health resource utilization. Expected Outcomes This will be the first randomized controlled trial to compare directly the health-related quality of life outcomes for ventral versus dorsal surgery for treating CSM. Discussion An NIH-funded (1R13AR065834-01) investigator meeting was held prior to initiating the trial in order to bring multiple stakeholders together to finalize the study protocol. Study investigators, coordinators, and major stakeholders were able to attend and discuss strengths, limitations, and concerns regarding the study. The final protocol was approved for funding by PCORI (CE-1304-6173). The RCT began enrollment on April 1, 2014. PMID:24991714

Outcomes of an extended-infusion piperacillin-tazobactam protocol implementation in a community teaching hospital adult intensive care unit.

PubMed

Schmees, Patrick M; Bergman, Scott J; Strader, Brandi D; Metzke, Megan E; Pointer, Sarah; Valenti, Kristine M

2016-06-01

The purpose of this study is to evaluate the outcome differences between patients receiving piperacillin-tazobactam pre- and post-implementation of an extended infusion dosing protocol in a community teaching hospital adult intensive care unit. On December 19th, 2011, extended infusion dosing of piperacillin-tazobactam was implemented at St. John's Hospital's intensive and cardiac care units (ICU/CCU) following IRB-approval. This is a historical case-control cohort study involving review of electronic medical charts of patients who received traditional or extended infusion therapy. Data was collected for patients that received piperacillin-tazobactam in the ICU/CCU from December 19th, 2010 through March 19th, 2011 for traditional infusion and from December 19th, 2011 through March 19th, 2012 for extended infusion. Primary endpoints were ICU/CCU mortality at discharge and length of stay. The study included 113 patients with 52 in the traditional-infusion group and 61 extended-infusion group. There was no statistically significant difference in the primary end-point of ICU/CCU mortality between the two groups (14.8% vs. 21.1%; p = 0.374). In the extended infusion group, there was a shorter length of ICU and CCU stay (8.32 vs. 12.06 days; p = 0.025) and shorter length of hospital stay (11.32 vs. 19.7 days; p = 0.006). The extended-infusion group showed a decrease in cost of therapy that was statistically significant ($120.21 vs. $155.17; p = 0.035). Adverse drug effects did not differ between the two study groups. This study showed that treatment with extended-infusion piperacillin-tazobactam therapy improved patient outcomes while maintaining patient safety and decreasing costs. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Immunotherapy Combination Approved for Advanced Kidney Cancer

Cancer.gov

FDA has approved the combination of the immunotherapy drugs nivolumab (Opdivo) and ipilimumab (Yervoy) as an initial treatment for some patients with advanced kidney cancer. The approval is expected to immediately affect patient care, as this Cancer Currents post explains.

Phase 2 Clinical Trial of AC105 (Mg/PEG) for Treatment of Acute Spinal Cord Injury (SCI)

DTIC Science & Technology

2015-12-01

initiation of 10 centers in the first 6 months, and an additional 10 centers over the next 6 months, the subject recruitment phase would have...Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 FDA Approval, Planning & Rolling Initiation of Sites Active phase of study: 6 & 12 month follow-ups Data...analysis Reports The Proposed Milestones for the project were: 1. Month 3 – FDA approval of clinical protocol 2. Month 6 – First site initiation and IRB

Mesenchymal Stem Cell Preparation and Transfection-free Ferumoxytol Labeling for MRI Cell Tracking.

PubMed

Liu, Li; Ho, Chien

2017-11-15

Mesenchymal stem cells (MSCs) are multipotent cells and are the most widely studied cell type for stem cell therapies. In vivo cell tracking of MSCs labeled with an FDA-approved superparamagnetic iron-oxide (SPIO) particle by magnetic resonance imaging (MRI) provides essential information, e.g., MSC engraftment, survival, and fate, thus improving cell therapy accuracy. However, current methodology for labeling MSCs with Ferumoxytol (Feraheme ® ), the only FDA-approved SPIO particle, needs transfection agents. This unit describes a new "bio-mimicry" protocol to prepare more native MSCs by using more "in vivo environment" of MSCs, so that the phagocytic activity of cultured MSCs is restored and expanded MSCs can be labeled with Ferumoxytol, without the need for transfection agents and/or electroporation. Moreover, MSCs re-size to a more native size, reducing from 32.0 to 19.5 μm. The MSCs prepared from this protocol retain more native properties and would be useful for biomedical applications and MSC-tracking studies by MRI. © 2017 by John Wiley & Sons, Inc. Copyright © 2017 John Wiley & Sons, Inc.

29 CFR 1952.10 - Requirements for approval of State posters.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 9 2013-07-01 2013-07-01 false Requirements for approval of State posters. 1952.10 Section... and Conditions § 1952.10 Requirements for approval of State posters. (a)(1) In order to inform..., States with approved plans shall develop and require employers to post a State poster meeting the...

29 CFR 1952.10 - Requirements for approval of State posters.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 9 2011-07-01 2011-07-01 false Requirements for approval of State posters. 1952.10 Section... and Conditions § 1952.10 Requirements for approval of State posters. (a)(1) In order to inform..., States with approved plans shall develop and require employers to post a State poster meeting the...

29 CFR 1952.10 - Requirements for approval of State posters.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 9 2014-07-01 2014-07-01 false Requirements for approval of State posters. 1952.10 Section... and Conditions § 1952.10 Requirements for approval of State posters. (a)(1) In order to inform..., States with approved plans shall develop and require employers to post a State poster meeting the...

29 CFR 1952.10 - Requirements for approval of State posters.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 9 2012-07-01 2012-07-01 false Requirements for approval of State posters. 1952.10 Section... and Conditions § 1952.10 Requirements for approval of State posters. (a)(1) In order to inform..., States with approved plans shall develop and require employers to post a State poster meeting the...

29 CFR 1952.10 - Requirements for approval of State posters.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Requirements for approval of State posters. 1952.10 Section... and Conditions § 1952.10 Requirements for approval of State posters. (a)(1) In order to inform..., States with approved plans shall develop and require employers to post a State poster meeting the...

34 CFR 686.21 - Calculation of a grant.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., a student's participation in a program of study abroad if it is approved for credit by the home... TEACH Grants for undergraduate and post-baccalaureate study may not exceed $16,000. (ii) The aggregate...

34 CFR 686.21 - Calculation of a grant.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., a student's participation in a program of study abroad if it is approved for credit by the home... TEACH Grants for undergraduate and post-baccalaureate study may not exceed $16,000. (ii) The aggregate...

34 CFR 686.21 - Calculation of a grant.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., a student's participation in a program of study abroad if it is approved for credit by the home... TEACH Grants for undergraduate and post-baccalaureate study may not exceed $16,000. (ii) The aggregate...

Institutional review board-based recommendations for medical institutions pursuing protocol approval for facial transplantation.

PubMed

Siemionow, Maria Z; Gordon, Chad R

2010-10-01

Preliminary outcomes from the previous nine face transplants performed since 2005 have been encouraging and have therefore led to a rise in the number of medical centers interested in establishing face transplant programs worldwide. However, until now, very little literature has been published providing surgeons the necessary insight on how to (1) prepare a protocol for institutional review board approval and (2) establish a face transplant program. The authors' face transplant team's experience with the institutional review board at the Cleveland Clinic, beginning in 2002, was critically reviewed in a detailed, retrospective manner. The purpose was to identify and define certain criteria necessary for both the institutional review board approval process and face transplant program establishment. In 2002, unprecedented efforts from within the authors' plastic surgery department led to the world's first institutional review board approval for face transplantation, in 2004. As a result, 4 years later, the authors' face transplant team performed the nation's first successful near-total face and maxilla transplant. Every surgical department hoping to establish a face transplant program must realize that this endeavor requires both tremendous financial and long-term commitments by its medical institution. These transplants should be performed only within university-based medical centers capable of orchestrating a specialized, talented, multidisciplinary team. More importantly, facial composite tissue allotransplantation possesses an unmatched level of complexity and therefore requires most centers to prepare a carefully detailed protocol using these institutional review board-based guidelines.

Hybrid protocols plus natural treatments for inflammatory conditions.

PubMed

1998-01-01

Hybrid protocols combine one, two, or three pharmaceutical drugs with several nutritional or immune-based therapies. These protocols are not limited solely to FDA-approved drugs or strictly to alternative therapies. The rationale for using a hybrid protocol is to find an effective antiviral regimen that also restores immune function. The goal is to obtain the benefits of protease inhibitors without viral resistance and side effects which include problems with fat metabolism and cholesterol levels. Natural treatments for inflammatory conditions are also described. Options include licorice root, ginger root, and slippery elm.

Mapping by VESGEN of Blood Vessels in the Retinas of Astronauts Pre- and Post-Flight to the ISS

NASA Technical Reports Server (NTRS)

Parsons-Wingerter, P.; Vyas, R. J.; Murray, M. C.; Predovic, M.; Lim, S.; Vizzeri, G.; Taibbi, G.; Mason, S. S.; Zanello, S. B.; Young, M.

2017-01-01

Research by NASA [1] established that significant risks for visual and ocular impairments associated with increased intracranial pressure (VIIP) are incurred by microgravity spaceflight, especially long-duration missions. It is well established in physiology and pathology that a fundamental role of the microvasculature is to mediate fluid transfers and remodel actively in response to environmental, immune and other stresses. We therefore hypothesize that remodeling of retinal blood vessels necessarily occurs during accommodation of microgravity-induced fluid shifts prior to subsequent development of visual and ocular impairments. Potential contributions of retinal vascular remodeling to VIIP etiology are therefore being investigated by NASA's innovative VESsel GENeration Analysis (VESGEN) software for two studies: (1) U.S. crew members before and after ISS missions, and (2) head-down tilt in human subjects before and after 70 days of bed rest. We anticipate that results of the two studies will be complete by the Investigators Workshop (January 22, 2017). METHODS: For the 2013 NASA NRA award, we are concluding the analysis of 30 degree infrared (IR) Heidelberg Spectralis images of retinal blood vessels by VESGEN (patents pending), a mature, automated software developed as a translational and basic vascular research discovery tool, particularly for retinal vascular disease. Subjects of our retrospective study include eight ISS crew members monitored for routine occupational surveillance pre- and post-flight, who provided their study consents to NASAs Lifetime Surveillance of Astronaut Health (LSAH) in coordination with approval of the VESGEN retrospective study protocol by NASAs Institutional Review Board (IRB). The ophthalmic retinal images (average image resolution, approximately 5.6 microns per pixel) are blinded as to pre and post ISS status until the second portion of our study, when VESGEN results will be correlated with other ophthalmic and medical findings for the crew members. Due to image resolution challenges, a novel Matlab tool was developed for aligning pre and post images, and comparing (querying) the two images for differences in the morphology of small vessels. RESULTS: During the past year, LSAH approved the release of all astronaut retinal images to our study for VESGEN analysis. Substantial progress on the initial blinded portion of the study is in place. We anticipate that VESGEN analysis of the 32 Spectralis IR retinal images will be complete for presentation at the 2017 IWS meeting. CONCLUSIONS: Modified retinal vascular patterning may offer early-stage predictions of ocular changes resulting in decreased visual acuity for the VIIP syndrome. Novel insights provided by VESGEN into progressively pathological and blinding vascular remodeling in the human retina currently help to guide other NIH- and NASA-supported therapeutic studies of retinal disease and modeling of the VIIP risk. Results of our vascular investigation of the retinas of astronauts pre- and post-flight may help advance the understanding of both healthy and pathological adaptations to fluid shifts in microgravity associated with the VIIP syndrome. Preliminary results indicate that imaging of higher resolution, such as the new OCT angiography (OCT-A) technology, will be required to determine conclusively the role of the smaller retinal and choroidal vessels in VIIP etiology.

Relative reductions in soluble CD30 levels post-transplant predict acute graft function in islet allograft recipients receiving three different immunosuppression protocols.

PubMed

Hire, Kelly; Hering, Bernhard; Bansal-Pakala, Pratima

2010-08-01

Despite advances in islet transplantation, challenges remain in monitoring for anti-islet immune responses. Soluble CD30 (sCD30) has been investigated as a predictor of acute rejection in kidney, lung, and heart transplantation as well as in a single study in human islet cell recipients. In this study, sCD30 levels were retrospectively assessed in 19 allograft recipients treated with three different immunosuppression induction therapies. Soluble CD30 levels were assessed at pre-transplant; early post-transplant (day 4-day 7); one-month post-transplant; and late post-transplant (day 90-day 120) and then correlated with eventual graft outcomes at 1-year follow-up. Results showed no correlation between mean serum sCD30 levels at any point in time pre- or post-transplant and graft function at 1-year follow-up. However, analysis demonstrated that mean sCD30 levels at day 28 or day 90-day 120 decreased from pre-transplant levels in recipients with long-term islet allograft function compared to recipients with partial or non-graft function (a decrease of 43.6+/-25.6% compared to 16.7+/-35.2%, p<0.05). In another finding, immunosuppression with the ATG protocol led to a greater reduction in sCD30 levels post-transplant overall. A larger reduction post-transplant correlated with full graft function. The results demonstrate that a relative reduction in sCD30 levels post-transplant may be applicable as a biomarker to monitor graft function in islet allograft recipients. Additionally, knowledge of the impact of various immunosuppression protocols on the timing and extent of changes in post-transplant sCD30 levels could aid in patient-specific tailoring of immunosuppression. Copyright © 2010 Elsevier B.V. All rights reserved.

Comparing Voice-Therapy and Vocal-Hygiene Treatments in Dysphonia Using a Limited Multidimensional Evaluation Protocol

ERIC Educational Resources Information Center

Rodriguez-Parra, Maria J.; Adrian, Jose A.; Casado, Juan C.

2011-01-01

Purpose: This study evaluates the effectiveness of two different programs of voice-treatment on a heterogeneous group of dysphonic speakers and the stability of therapeutic progress for longterm follow-up post-treatment period, using a limited multidimensional protocol of evaluation. Method: Forty-two participants with voice disorders were…

Impact of a Step Therapy for Guanfacine Extended-Release on Medication Utilization and Health Care Expenditures Among Individuals Receiving Treatment for ADHD.

PubMed

Suehs, Brandon T; Sikirica, Vanja; Mudumby, Pallavi; Dufour, Robert; Patel, Nick C

2015-09-01

While step therapy (ST) policies are generally effective at reducing cost through the managed utilization of targeted medications, the clinical implications of ST policies are not clear and may vary across therapeutic areas. Guanfacine extended-release (GXR) is approved by the FDA for the treatment of attention-deficit/hyperactivity disorder (ADHD) as both monotherapy and adjunctive to stimulant treatment. At the introduction of GXR to the market, Humana implemented an ST policy on GXR requiring the documentation of previous treatment, intolerance, or contraindication to generic clonidine or guanfacine. To examine the impact of a GXR ST coverage determination (i.e., approved vs. denied) on medication utilization and health care costs among members of a commercial health plan with an ST policy for GXR.  This study was a retrospective cohort study of administrative claims data. Humana commercial members prescribed GXR who had an ST coverage determination review were identified. All members included in this analysis were required to be aged 6-17 years, have a diagnosis of ADHD or be receiving stimulant medication, have an ST coverage determination (index event) between September 1, 2009, and May 30, 2012, and have 6 months of pre- and post-index continuous enrollment. Members were assigned to either the approved or denied group based on the outcome of the ST coverage determination. Medical and pharmacy claims data were used to measure baseline demographic and clinical characteristics and to measure medication utilization and health care costs. Outcomes assessed during follow-up included ADHD medication use, proportion of days covered (PDC) with any ADHD medication treatment, time to first observed post-index ADHD treatment, and all-cause and mental health (MH)-related health care costs. Administrative costs associated with the coverage determination process were also estimated. Bivariate and multivariable adjusted analyses were conducted to compare medication utilization and health care costs between the approved and denied groups. A total of 642 members were included in the analysis (denied group n = 395 [61.5%], approved group n = 247 [38.5%]). The approved and denied groups were similar in terms of baseline demographics, provider characteristics, and baseline MH diagnoses, with the exception of anxiety disorders being more prevalent in the approved group compared with the denied group (18.2% vs. 10.6%, P = 0.006). A denied GXR coverage determination was associated with a greater percentage of members receiving no ADHD treatment post-index (13.9% vs. 3.2%, P  less than  0.001), greater mean [SD] number of days between index and first observed post-index ADHD medication claim (44.5 [59.6] vs. 17.6 [33.4], P  less than  0.001), and lower mean [SD] PDC with any ADHD medication post-index (0.59 [0.33] vs. 0.75 [0.26], P  less than  0.001). These findings remained statistically significant in multivariable regression models. Unadjusted pre-index median total health care costs and MH-related costs were greater among the approved group compared with the denied group (total health care: $1,582 vs. $1,465, P = 0.033; MH-related: $993 vs. $981, P = 0.020). Likewise, post-index median total health care and MH-related costs were greater among the approved group compared with the denied group (total: $2,056 vs. $1,420, P  less than  0.001; MH-related: $1,543 vs. $946, P  less than  0.001). After adjustment for potentially confounding covariates including pre-index costs, there were no statistically significant differences between the approved and denied groups in all-cause total health care (P = 0.393) or MH-related health care costs (P = 0.054).  The current study found that GXR coverage denial was associated with lower rate of ADHD medication utilization, greater delay in receiving ADHD medication, and lower PDC with ADHD medication. There were no differences observed between the approved and denied group in terms of all-cause total health care or MH-related total health care costs after controlling for potentially confounding variables. Prior to implementation in the ADHD therapeutic area and others, payers should consider the potentially unintended consequences of ST policies, including delay in treatment and undertreatment.

Tisagenlecleucel (Kymriah) Approved to Treat Some Lymphomas

Cancer.gov

FDA has approved the CAR T-cell therapy tisagenlecleucel for adults with diffuse large B-cell lymphoma that is relapsed or refractory. Learn more about this new approval and how it may affect patients in this NCI Cancer Currents blog post.

Estimation of radiation dosimetry for 68Ga-HBED-CC (PSMA-11) in patients with suspected recurrence of prostate cancer.

PubMed

Green, Mark A; Eitel, Jacob A; Fletcher, James W; Mathias, Carla J; Tann, Mark A; Gardner, Thomas; Koch, Michael O; Territo, Wendy; Polson, Heather; Hutchins, Gary D

2017-03-01

This study was performed to estimate the human radiation dosimetry for [ 68 Ga]Ga-HBED-CC (PSMA-11) ( 68 Ga PSMA-11). Under an RDRC-approved research protocol, we evaluated the biodistribution and pharmacokinetics of 68 Ga PSMA-11 with serial PET imaging following intravenous administration to nine prostate cancer patients in whom clinical [ 11 C]acetate PET/CT exams had been independently performed under Expanded Access IND 118,204. List-mode imaging was performed over the initial 0-10min post-injection with the pelvis in the field-of-view. Whole-body images were acquired, pelvis-to-head, at 15, 60, and 90-min post-injection. Additional images of the pelvis were acquired at 40-min and 115-min, and voided urine collected from each subject at 48-min and 120-min post-injection. Radiation dosimetry estimates were calculated from these data using the OLINDA software package. Renal uptake was high and relatively invariant, ranging from 11% to 14% of the injected dose between 15 and 90-min post-injection. Radioactivity collected in the voided urine accounted for 14% of the injected dose over a period of 120-min. Lymph nodes and skeletal metastases suspicious for prostate cancer recurrence were detected in a greater number of patients using 68 Ga PSMA-11 than using 11 C-acetate. Kidneys are the critical organ following 68 Ga PSMA-11 administration, receiving an estimated dose of 0.413mGy/MBq. This study confirms that the kidneys will be the critical organ following intravenous administration of 68 Ga PSMA-11, and provided data consistent with the expectation that 68 Ga PSMA-11 will be superior to [ 11 C]acetate for defining sites of recurrence in prostate cancer patients presenting with biochemical relapse. Copyright © 2016 Elsevier Inc. All rights reserved.

Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery.

PubMed

Warner, Matthew A; Welsby, Ian J; Norris, Phillip J; Silliman, Christopher C; Armour, Sarah; Wittwer, Erica D; Santrach, Paula J; Meade, Laurie A; Liedl, Lavonne M; Nieuwenkamp, Chelsea M; Douthit, Brian; van Buskirk, Camille M; Schulte, Phillip J; Carter, Rickey E; Kor, Daryl J

2017-08-18

The transfusion-related respiratory complications, transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO), are leading causes of transfusion-related morbidity and mortality. At present, there are no effective preventive strategies with red blood cell (RBC) transfusion. Although mechanisms remain incompletely defined, soluble biological response modifiers (BRMs) within the RBC storage solution may play an important role. Point-of-care (POC) washing of allogeneic RBCs may remove these BRMs, thereby mitigating their impact on post-transfusion respiratory complications. This is a multicenter randomised clinical trial of standard allogeneic versus washed allogeneic RBC transfusion for adult patients undergoing cardiac surgery testing the hypothesis that POC RBC washing is feasible, safe, and efficacious and will reduce recipient immune and physiologic responses associated with transfusion-related respiratory complications. Relevant clinical outcomes will also be assessed. This investigation will enrol 170 patients at two hospitals in the USA. Simon's two-stage design will be used to assess the feasibility of POC RBC washing. The primary safety outcomes will be assessed using Wilcoxon Rank-Sum tests for continuous variables and Pearson chi-square test for categorical variables. Standard mixed modelling practices will be employed to test for changes in biomarkers of lung injury following transfusion. Linear regression will assess relationships between randomised group and post-transfusion physiologic measures. Safety oversight will be conducted under the direction of an independent Data and Safety Monitoring Board (DSMB). Approval of the protocol was obtained by the DSMB as well as the institutional review boards at each institution prior to enrolling the first study participant. This study aims to provide important information regarding the feasibility of POC washing of allogeneic RBCs and its potential impact on ameliorating post-transfusion respiratory complications. Additionally, it will inform the feasibility and scientific merit of pursuing a more definitive phase II/III clinical trial. ClinicalTrials.gov registration number is NCT02094118 (Pre-results). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Real-time X-ray Imaging of Lung Fluid Volumes in Neonatal Mouse Lung.

PubMed

Van Avermaete, Ashley E; Trac, Phi T; Gauthier, Theresa W; Helms, My N

2016-07-18

At birth, the lung undergoes a profound phenotypic switch from secretion to absorption, which allows for adaptation to breathing independently. Promoting and sustaining this phenotype is critically important in normal alveolar growth and gas exchange throughout life. Several in vitro studies have characterized the role of key regulatory proteins, signaling molecules, and steroid hormones that can influence the rate of lung fluid clearance. However, in vivo examinations must be performed to evaluate whether these regulatory factors play important physiological roles in regulating perinatal lung liquid absorption. As such, the utilization of real time X-ray imaging to determine perinatal lung fluid clearance, or pulmonary edema, represents a technological advancement in the field. Herein, we explain and illustrate an approach to assess the rate of alveolar lung fluid clearance and alveolar flooding in C57BL/6 mice at post natal day 10 using X-ray imaging and analysis. Successful implementation of this protocol requires prior approval from institutional animal care and use committees (IACUC), an in vivo small animal X-ray imaging system, and compatible molecular imaging software.

Vocations: The Link between Post-Compulsory Education and the Labour Market. What the Research Says For... Qualification & Approval Bodies

ERIC Educational Resources Information Center

Wheelahan, Leesa; Buchanan, John; Yu, Serena

2015-01-01

This summary pulls together the relevant key findings for qualification and approval bodies from the research program "Vocations: The Link between Post-Compulsory Education and the Labour Market." The program was comprised of three different strands: (1) pathways from VET in Schools, (2) pathways within and between vocational education…

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

PubMed

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

2016-03-24

Obsessive-compulsive disorder (OCD) is a disabling psychopathology. The mainstay of treatment includes cognitive-behavioural therapy (CBT) and medication management. However, individual suffering, functional impairments as well as the direct and indirect costs associated with the disease remain substantial. New treatment programmes are necessary and the brief strategic therapy (BST) has recently shown encouraging results in clinical practice but no quantitative study has as yet been conducted. The clinical effectiveness of the OCD-specific BST protocol will be evaluated in a one-group observational study. Participants will be sequentially recruited from a state community psychotherapy clinic in Dublin, Ireland. Outcome measures will be the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the Beck Depression Inventory-II (BDI-II). Data will be collected at baseline, at treatment termination and at 3 month follow-up. The statistical significance of the post-treatment effect will be assessed by the paired-sample Student t test, while clinical significance will be evaluated by means of the equivalence testing method, which will be also used to assess the maintenance of effect at follow-up. The present study is approved by the Hesed House Ethics Board in Dublin. Findings will enhance the evidence-based knowledge about the clinical effectiveness of BST in treating OCD symptoms, prior to assessing its efficacy in a randomised and controlled clinical trial, and will be disseminated through publication in peer-reviewed journals and conference presentations. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Radiation Dose Index of Renal Colic Protocol CT Studies in the United States

PubMed Central

Lukasiewicz, Adam; Bhargavan-Chatfield, Mythreyi; Coombs, Laura; Ghita, Monica; Weinreb, Jeffrey; Gunabushanam, Gowthaman; Moore, Christopher L.

2016-01-01

Purpose To determine radiation dose indexes for computed tomography (CT) performed with renal colic protocols in the United States, including frequency of reduced-dose technique usage and any institutional-level factors associated with high or low dose indexes. Materials and Methods The Dose Imaging Registry (DIR) collects deidentified CT data, including examination type and dose indexes, for CT performed at participating institutions; thus, the DIR portion of the study was exempt from institutional review board approval and was HIPAA compliant. CT dose indexes were examined at the institutional level for CT performed with a renal colic protocol at institutions that contributed at least 10 studies to the registry as of January 2013. Additionally, patients undergoing CT for renal colic at a single institution (with institutional review board approval and informed consent from prospective subjects and waiver of consent from retrospective subjects) were studied to examine individual renal colic CT dose index patterns and explore relationships between patient habitus, demographics, and dose indexes. Descriptive statistics were used to analyze dose indexes, and linear regression and Spearman correlations were used to examine relationships between dose indexes and institutional factors. Results There were 49 903 renal colic protocol CT examinations conducted at 93 institutions between May 2011 and January 2013. Mean age ± standard deviation was 49 years ± 18, and 53.9% of patients were female. Institutions contributed a median of 268 (interquartile range, 77–699) CT studies. Overall mean institutional dose-length product (DLP) was 746 mGy · cm (effective dose, 11.2 mSv), with a range of 307–1497 mGy · cm (effective dose, 4.6–22.5 mSv) for mean DLPs. Only 2% of studies were conducted with a DLP of 200 mGy · cm or lower (a “reduced dose”) (effective dose, 3 mSv), and only 10% of institutions kept DLP at 400 mGy · cm (effective dose, 6 mSv) or less in at least 50% of patients. Conclusion Reduced-dose renal protocol CT is used infrequently in the United States. Mean dose index is higher than reported previously, and institutional variation is substantial. PMID:24484064

Promoting Optimal Physical Exercise for Life (PROPEL): aerobic exercise and self-management early after stroke to increase daily physical activity-study protocol for a stepped-wedge randomised trial.

PubMed

Mansfield, Avril; Brooks, Dina; Tang, Ada; Taylor, Denise; Inness, Elizabeth L; Kiss, Alex; Middleton, Laura; Biasin, Louis; Fleck, Rebecca; French, Esmé; LeBlanc, Kathryn; Aqui, Anthony; Danells, Cynthia

2017-06-30

Physical exercise after stroke is essential for improving recovery and general health, and reducing future stroke risk. However, people with stroke are not sufficiently active on return to the community after rehabilitation. We developed the Promoting Optimal Physical Exercise for Life (PROPEL) programme, which combines exercise with self-management strategies within rehabilitation to promote ongoing physical activity in the community after rehabilitation. This study aims to evaluate the effect of PROPEL on long-term participation in exercise after discharge from stroke rehabilitation. We hypothesise that individuals who complete PROPEL will be more likely to meet recommended frequency, duration and intensity of exercise compared with individuals who do not complete the programme up to 6 months post discharge from stroke rehabilitation. Individuals undergoing outpatient stroke rehabilitation at one of six hospitals will be recruited (target n=192 total). A stepped-wedge design will be employed; that is, the PROPEL intervention (group exercise plus self-management) will be 'rolled out' to each site at a random time within the study period. Prior to roll-out of the PROPEL intervention, sites will complete the control intervention (group aerobic exercise only). Participation in physical activity for 6 months post discharge will be measured via activity and heart rate monitors, and standardised physical activity questionnaire. Adherence to exercise guidelines will be evaluated by (1) number of 'active minutes' per week (from the activity monitor), (2) amount of time per week when heart rate is within a target range (ie, 55%-80% of age-predicted maximum) and (3) amount of time per week completing 'moderate' or 'strenuous' physical activities (from the questionnaire). We will compare the proportion of active and inactive individuals at 6 months post intervention using mixed-model logistic regression, with fixed effects of time and phase and random effect of cluster (site). To date, research ethics approval has been received from five of the six sites, with conditional approval granted by the sixth site. Results will be disseminated directly to study participants at the end of the trial, and to other stake holders via publication in a peer-reviewed journal. NCT02951338; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

77 FR 39924 - Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-06

.... FDA-2011-N-0505] Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent... application (PMA) or a notice of completion of a product development protocol (PDP) for the cardiovascular...) of the FD&C Act of a PMA or notice of completion of a PDP for the cardiovascular permanent pacemaker...

Effectiveness of a multiple-strategy community intervention to reduce maternal and child health inequalities in Haryana, North India: a mixed-methods study protocol

PubMed Central

Gupta, Madhu; Angeli, Federica; van Schayck, Onno C. P.; Bosma, Hans

2015-01-01

Background A multiple-strategy community intervention, known as National Rural Health Mission (NRHM), launched in India to improve the availability of and access to better-quality healthcare, especially for rural, poor mothers and children. The final goal of the intervention is to reduce maternal and child health inequalities across geographical areas, socioeconomic status groups, and sex of the child. Extensive, in-depth research is necessary to assess the effectiveness of NRHM, on multiple outcome dimensions. This paper presents the design of a new study, able to overcome the shortcomings of previous research. Objective To propose a comprehensive, methodologically sound protocol to assess the extent of implementation and the effectiveness of NRHM measures to improve maternal and child health outcomes and reduce maternal and child health inequalities. Design A mixed-methods approach (quantitative and qualitative) is proposed for this study in Haryana, a state in North India. NRHM's health sector plans included health system strengthening, specific maternal and child healthcare strategies, and communitization. Mission documents and reports on progress, financial monitoring, and common and joint review will be reviewed in-depth to assess the extent of the implementation of plans. Data on maternal and child health indicators will be obtained from demographic health surveys held before, during, and after the implementation of the first phase of the NRHM (2005–2012) and compared over time. Differences in maternal and child health indicators will be used to measure maternal and child health inequalities; these will be compared pre- and post-NRHM. Focus group discussions (FGDs) with service providers and in-depth interviews with program managers, community representatives, and mothers will be conducted until data saturation is achieved, in two districts of Haryana. Using Nvivo software, an inductive qualitative content analysis will be performed to search for the broader themes across the interviews and FGDs. Ethical approval was obtained from the Ethics Committee of the Post Graduate Institute of Medical Education and Research. PMID:25676665

Abemaciclib gets new approval for breast cancer

Cancer.gov

DA has approved the CDK4/6 inhibitor abemaciclib (Verzenio) as a first-line treatment in some women with advanced or metastatic breast cancer. Under the approval, it must be used in combination with an aromatase inhibitor, as this Cancer Currents blog post explains.

Self-reported pain after orthodontic treatments: a randomized controlled study on the effects of two follow-up procedures

PubMed Central

Cozzani, Mauro; Delucchi, Alessia; Barreca, Carlo; Rinchuse, Daniel J.; Servetto, Roberto; Calevo, Maria Grazia; Piras, Vincenzo

2016-01-01

Summary Objectives: To assess the effects of a follow-up text message and a telephone call after bonding on participants’ self-reported level of pain. Materials and methods: Eighty-four participants were randomly assigned to one of three trial arms. Randomization was performed by the Department of Epidemiology and Biostatistics of IRCCS G.Gaslini. Participants were enrolled from patients with a permanent dentition who were beginning fixed no extraction treatment at the Orthodontic Department, Gaslini Hospital. Participants completed baseline questionnaires to assess their levels of pain prior to treatment. After the initial appointment, participants were completed a pain questionnaire at the same time, daily, for 7 days. The first group, served as control, did not receive any post-procedure communication; the second group received a structured text message; and the third group received a structured telephone call. Participants were blinded to group assignment. Limitations: A larger sample size should have been considered in order to increase the ability to generalize this study’s results. Results: Participants in both the telephone call group and the text message group reported lower level of pain than participants in the control group with a larger and more consistent effect for the telephone call group. Most participants reported a higher level of pain during the first 48 hours post-bonding. The analgesic’s consumption significantly correlated with the level of pain during the previous 24 hours. Female participants appeared to be more sensitive to pain than male participants. Conclusions: A telephone follow-up after orthodontic treatment may be an effective procedure to reduce participants’ level of pain. Protocol: The research protocol was approved by the Italian Comitato Etico Regionale della Liguria-sezione 3^ c/o IRCCS- Istituto G.Gaslini 845/2014. Registration: 182 Reg 2014, 16/09/2014 Comitato Etico Regione Liguria, Sez.3. PMID:26070922

Mechanisms of CTC Biomarkers in Breast Cancer Brain Metastasis

DTIC Science & Technology

2015-10-01

3. ACCOMPLISHMENTS What were the major goals of the project? Dr. David Hong at MD Anderson was the partnering PI of this protocol . The major...blood (CTC analyses). Peripheral blood samples and tumor tissues will be collected and provided by Dr. David Hong under a MDACC IRB- protocol which has...per IRB-approved protocol ) will be drawn and immediately undergo CTC analyses. Blood may be drawn from the same individual on more than one occasion

A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.

PubMed

Coppens, D G M; de Wilde, S; Guchelaar, H J; De Bruin, M L; Leufkens, H G M; Meij, P; Hoekman, J

2018-05-02

There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Three-dimensional assessment of the asymptomatic and post-stroke shoulder: intra-rater test-retest reliability and within-subject repeatability of the palpation and digitization approach.

PubMed

Pain, Liza A M; Baker, Ross; Sohail, Qazi Zain; Richardson, Denyse; Zabjek, Karl; Mogk, Jeremy P M; Agur, Anne M R

2018-03-23

Altered three-dimensional (3D) joint kinematics can contribute to shoulder pathology, including post-stroke shoulder pain. Reliable assessment methods enable comparative studies between asymptomatic shoulders of healthy subjects and painful shoulders of post-stroke subjects, and could inform treatment planning for post-stroke shoulder pain. The study purpose was to establish intra-rater test-retest reliability and within-subject repeatability of a palpation/digitization protocol, which assesses 3D clavicular/scapular/humeral rotations, in asymptomatic and painful post-stroke shoulders. Repeated measurements of 3D clavicular/scapular/humeral joint/segment rotations were obtained using palpation/digitization in 32 asymptomatic and six painful post-stroke shoulders during four reaching postures (rest/flexion/abduction/external rotation). Intra-class correlation coefficients (ICCs), standard error of the measurement and 95% confidence intervals were calculated. All ICC values indicated high to very high test-retest reliability (≥0.70), with lower reliability for scapular anterior/posterior tilt during external rotation in asymptomatic subjects, and scapular medial/lateral rotation, humeral horizontal abduction/adduction and axial rotation during abduction in post-stroke subjects. All standard error of measurement values demonstrated within-subject repeatability error ≤5° for all clavicular/scapular/humeral joint/segment rotations (asymptomatic ≤3.75°; post-stroke ≤5.0°), except for humeral axial rotation (asymptomatic ≤5°; post-stroke ≤15°). This noninvasive, clinically feasible palpation/digitization protocol was reliable and repeatable in asymptomatic shoulders, and in a smaller sample of painful post-stroke shoulders. Implications for Rehabilitation In the clinical setting, a reliable and repeatable noninvasive method for assessment of three-dimensional (3D) clavicular/scapular/humeral joint orientation and range of motion (ROM) is currently required. The established reliability and repeatability of this proposed palpation/digitization protocol will enable comparative 3D ROM studies between asymptomatic and post-stroke shoulders, which will further inform treatment planning. Intra-rater test-retest repeatability, which is measured by the standard error of the measure, indicates the range of error associated with a single test measure. Therefore, clinicians can use the standard error of the measure to determine the "true" differences between pre-treatment and post-treatment test scores.

Mobile technology intervention to improve care coordination between HIV and substance use treatment providers: development, training, and evaluation protocol.

PubMed

Claborn, Kasey; Becker, Sara; Ramsey, Susan; Rich, Josiah; Friedmann, Peter D

2017-03-14

People living with HIV (PLWH) with a substance use disorder (SUD) tend to receive inadequate medical care in part because of a siloed healthcare system in which HIV and substance use services are delivered separately. Ideal treatment requires an interdisciplinary, team-based coordinated care approach, but many structural and systemic barriers impede the integration of HIV and SUD services. The current protocol describes the development and preliminary evaluation of a care coordination intervention (CCI), consisting of a tablet-based mobile platform for HIV and SUD treatment providers, an interagency communication protocol, and a training protocol. We hypothesize that HIV and SUD treatment providers will find the CCI to be acceptable, and that after receipt of the CCI, providers will: exhibit higher retention in dual care among patients, report increased frequency and quality of communication, and report increased rates of relational coordination. A three phase approach is used to refine and evaluate the CCI. Phase 1 consists of in-depth qualitative interviews with 8 key stakeholders as well as clinical audits of participating HIV and SUD treatment agencies. Phase 2 contains functionality testing of the mobile platform with frontline HIV and SUD treatment providers, followed by refinement of the CCI. Phase 3 consists of a pre-, post-test trial with 30 SUD and 30 HIV treatment providers. Data will be collected at the provider, organization, and patient levels. Providers will complete assessments at baseline, immediately post-training, and at 1-, 3-, and 6-months post-training. Organizational data will be collected at baseline, 1-, 3-, and 6-months post training, while patient data will be collected at baseline and 6-months post training. This study will develop and evaluate a CCI consisting of a tablet-based mobile platform for treatment providers, an interagency communication protocol, and a training protocol as a means of improving the integration of care for PLWH who have a SUD. Results have the potential to advance the field by bridging gaps in a fragmented healthcare system, and improving treatment efficiency, work flow, and communication among interdisciplinary providers from different treatment settings. NCT02906215.

Resource Utilization After Snakebite Severity Score Implementation into Treatment Algorithm of Crotaline Bite.

PubMed

Fowler, Amanda L; Hughes, Darrel W; Muir, Mark T; VanWert, Elizabeth M; Gamboa, Conrado D; Myers, John G

2017-12-01

Crotaline envenomation clinical manifestations vary considerably among patients. Current recommendations for treatment with Crotalidae polyvalent immune Fab require assessment of envenomation control. Determining control of envenomation, particularly when patients are evaluated by different providers in separate clinical settings, can be difficult. To determine if a difference in total vials of Crotalidae antivenin therapy exists between pre-protocol and post-Snakebite Severity Score (SSS) protocol. Retrospective medical record review at an academic medical and regional Level I trauma center. Resource utilization in patients with a diagnosis of "snakebite" was compared between patients treated pre- and post-SSS protocol implementation. One hundred forty-six patients were included in the evaluation. One hundred twenty-seven (87.0%) patients received antivenin, n = 80 (90.9%) in the pre-protocol group and n = 47 (81.0%) in the post-protocol group. Median total number of antivenin vials per patient was lower in the post-protocol group than the pre-protocol group, 16 (10-24 interquartile range) vs. 12 (10-16 interquartile range), p = 0.006. This decreased utilization correlates to an approximate $13,200 savings per patient. Hospital and intensive care unit length of stay, opioid use, incidence of blood product transfusion, need for surgical intervention, or need for intubation were not different between groups. A snakebite protocol with SSS utilization to guide antivenin administration results in significantly decreased antivenin therapy in snakebite patients without increase in other health care utilization. Copyright © 2017 Elsevier Inc. All rights reserved.

Biopsychosocial factors associated with non-recovery after a minor transport-related injury: protocol for a systematic review.

PubMed

Samoborec, Stella; Ruseckaite, Rasa; Romero, Lorena; Evans, Sue M

2017-09-03

Globally, road transport accidents contribute substantially to the number of deaths and also to the burden of disability. Up to 50 million people suffer a transport-related non-fatal injury each year, which often leads to long-term disability. It has been shown that substantial number of people with minor injuries struggle to recover and the reasons are still not well explored.Despite the high prevalence, little is known about the factors hindering recovery following minor traffic-related injuries. The aim of this paper is to present a protocol for the systematic review aiming to understand biopsychosocial factors related to non-recovery and identify current gaps in the literature. The review will be conducted in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol guidelines. A search of the electronic databases, MEDLINE, EMBASE, Cochrane Central Register of Controlled trials, will be undertaken, in addition to Google Scholar and grey literature to identify studies in period from 2006 to 2016. Quantitative and qualitative research articles describing and identifying biopsychosocial factors associated with non-recovery and health outcomes such as pain, disability, functional recovery, health-related quality of life, post-traumatic stress disorder, depression, anxiety and return to work will be included. A conceptual framework developed to identify biopsychosocial factors will be applied to assure defined criterion.At present, there is little anticipation for meta-analyses due to the heterogeneity of factors and outcomes assessed. Therefore, a narrative synthesis based on study findings will be conducted. Ethical approval is not required as primary data will not be collected. Review results will be published as a part of thesis, peer-reviewed journal and conferences. PROSPEROregistration number: CRD42016052276. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

WASP (Write a Scientific Paper): Ethics approval for a research study (2).

PubMed

Mallia, Pierre

2018-05-03

Research Ethics Committees are composed of a minimum of five members which include a lay person, a member from a different institution and at least another three members which should be versed in ethics. Legal and expert advisors can be sought by the committee. The REC will require a detailed protocol from the researcher including the curriculum of the principal investigator and all other researchers under him/her. The protocol should include all details of the research to be undertaken including a detailed description, the reasons for the research, literature pertaining to the research, a clear description of the target population, the actual consent form including what information is to be given to the participants, a declaration where necessary that things prohibited by the law (such as use of embryonic stem cells if this is the case in the country [2] will not be researchers, and a declaration that the relevant directives and rules and procedures which the REC falls under will be followed. The REC will also require a description of any risks and what actions are to be undertaken to eliminate hazards. The researchers must adhere only to the protocol given and any changes, minor or major, must be reported to the REC and approved. Copyright © 2018. Published by Elsevier B.V.

A new method to assess Pavlovian conditioning of psychostimulant drug effects.

PubMed

Damianopoulos, E N; Carey, R J

1994-07-01

Experimental studies of psychoactive drugs by pavlovian drug-conditioning methods, which originally began with investigations of drug-induced responses mediated by the autonomic nervous system, have now been expanded to include drug-induced response effects expressed as modulations of spontaneous motoric behaviors. In the latter application, however, equivalent behavioral response outcomes in post-treatment tests for conditioning can occur following a psychostimulant drug treatment either through drug interference effects on habituation processes, drug-induced stress effects and/or by pavlovian conditioning of the drug-induced motoric activation effect. Current methodologies for the study of pavlovian conditioned drug effects and/or drug sensitization cannot distinguish among these possibilities. This methodological inadequacy was addressed by a modification of the conventional paired-unpaired treatment protocol. In the new protocol, the animal is sequentially placed into two test compartments with the drug treatment administered in conjunction with placement into the second test compartment. This design permits a differentiation of a pavlovian conditioned drug responses from non-conditioned drug effects through continuous measurement of the non-drug behavioral baseline in both the drug and non-drug control treatment groups combined with multiple response measurements and post-treatment tests for conditioning at variable post-conditioning intervals. The present study details the use of the new modified pavlovian protocol with repeated cocaine (10 mg/kg) treatment. A cocaine conditioned response at 1, 7, and 21 days post-conditioning was identified and distinguished from habituation and stress effects.

Neuromuscular Fatigue and Physiological Responses After Five Dynamic Squat Exercise Protocols.

PubMed

Raeder, Christian; Wiewelhove, Thimo; Westphal-Martinez, Marc P; Fernandez-Fernandez, Jaime; de Paula Simola, Rauno A; Kellmann, Michael; Meyer, Tim; Pfeiffer, Mark; Ferrauti, Alexander

2016-04-01

This aimed to analyze neuromuscular, physiological and perceptual responses to a single bout of 5 different dynamic squat exercise protocols. In a randomized and counterbalanced order, 15 male resistance-trained athletes (mean ± SD; age: 23.1 ± 1.9 years, body mass: 77.4 ± 8.0 kg) completed traditional multiple sets (MS: 4 × 6, 85% 1 repetition maximum [RM]), drop sets (DS: 1 × 6, 85% 1RM + 3 drop sets), eccentric overload (EO: 4 × 6, 70% 1RM concentric, 100% 1RM eccentric), flywheel YoYo squat (FW: 4 × 6, all-out), and a plyometric jump protocol (PJ: 4 × 15, all-out). Blood lactate (La), ratings of perceived exertion (RPE), counter movement jump height (CMJ), multiple rebound jump (MRJ) performance, maximal voluntary isometric contraction force, serum creatine kinase (CK) and delayed onset muscle soreness were measured. Immediately post exercise, La was significantly (p < 0.001) higher in FW (mean ± 95% confidence limit; 12.2 ± 0.9 mmol·L) and lower in PJ (3.0 ± 0.8 mmol·L) compared with MS (7.7 ± 1.5 mmol·L), DS (8.5 ± 0.6 mmol·L), and EO (8.2 ± 1.6 mmol·L), accompanied by similar RPE responses. Neuromuscular performance (CMJ, MRJ) significantly remained decreased (p < 0.001) from 0.5 to 48 hours post exercise in all protocols. There was a significant time × protocol interaction (p ≤ 0.05) in MRJ with a significant lower performance in DS, EO, and FW compared with PJ (0.5 hours post exercise), and in EO compared with all other protocols (24 hours post exercise). A significant main time effect with peak values 24 hours post exercise was observed in CK serum concentrations (p < 0.001), but there was no time × protocol interaction. In conclusion, (a) metabolic and perceptual demands were higher in FW and EO compared with MS, DS and PJ, (b) neuromuscular fatigue was consistent up to 48 hours post exercise in all protocols, and (c) EO induced the greatest neuromuscular fatigue.

[Multidisciplinary protocol for computed tomography imaging and angiographic embolization of splenic injury due to trauma: assessment of pre-protocol and post-protocol outcomes].

PubMed

Koo, M; Sabaté, A; Magalló, P; García, M A; Domínguez, J; de Lama, M E; López, S

2011-11-01

To assess conservative treatment of splenic injury due to trauma, following a protocol for computed tomography (CT) and angiographic embolization. To quantify the predictive value of CT for detecting bleeding and need for embolization. The care protocol developed by the multidisciplinary team consisted of angiography with embolization of lesions revealed by contrast extravasation under CT as well as embolization of grade III-V injuries observed, or grade I-II injuries causing hemodynamic instability and/or need for blood transfusion. We collected data on demographic variables, injury severity score (ISS), angiographic findings, and injuries revealed by CT. Pre-protocol and post-protocol outcomes were compared. The sensitivity and specificity of CT findings were calculated for all patients who required angiographic embolization. Forty-four and 30 angiographies were performed in the pre- and post-protocol periods, respectively. The mean (SD) ISSs in the two periods were 25 (11) and 26 (12), respectively. A total of 24 (54%) embolizations were performed in the pre-protocol period and 28 (98%) after implementation of the protocol. Two and 7 embolizations involved the spleen in the 2 periods, respectively; abdominal laparotomies numbered 32 and 25, respectively, and 10 (31%) vs 4 (16%) splenectomies were performed. The specificity and sensitivity values for contrast extravasation found on CT and followed by embolization were 77.7% and 79.5%. The implementation of this multidisciplinary protocol using CT imaging and angiographic embolization led to a decrease in the number of splenectomies. The protocol allows us to take a more conservative treatment approach.

Effect of endoscopic transpapillary biliary drainage with/without endoscopic sphincterotomy on post-endoscopic retrograde cholangiopancreatography pancreatitis in patients with biliary stricture (E-BEST): a protocol for a multicentre randomised controlled trial.

PubMed

Kato, Shin; Kuwatani, Masaki; Sugiura, Ryo; Sano, Itsuki; Kawakubo, Kazumichi; Ono, Kota; Sakamoto, Naoya

2017-08-11

The effect of endoscopic sphincterotomy prior to endoscopic biliary stenting to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis remains to be fully elucidated. The aim of this study is to prospectively evaluate the non-inferiority of non-endoscopic sphincterotomy prior to stenting for naïve major duodenal papilla compared with endoscopic sphincterotomy prior to stenting in patients with biliary stricture. We designed a multicentre randomised controlled trial, for which we will recruit 370 patients with biliary stricture requiring endoscopic biliary stenting from 26 high-volume institutions in Japan. Patients will be randomly allocated to the endoscopic sphincterotomy group or the non-endoscopic sphincterotomy group. The main outcome measure is the incidence of pancreatitis within 2 days of initial transpapillary biliary drainage. Data will be analysed on completion of the study. We will calculate the 95% confidence intervals (CIs) of the incidence of pancreatitis in each group and analyse weather the difference in both groups with 95% CIs is within the non-inferiority margin (6%) using the Wald method. This study has been approved by the institutional review board of Hokkaido University Hospital (IRB: 016-0181). Results will be submitted for presentation at an international medical conference and published in a peer-reviewed journal. The University Hospital Medical Information Network ID: UMIN000025727 Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Evaluation of Factors that Contribute to Improving Academic Achievement of Career and Technical Education Students in Rhode Island

ERIC Educational Resources Information Center

Marsella, Anthony J.

2010-01-01

The primary purpose of this study was to gain a deeper understanding of career and technical education in Rhode Island utilizing Program Approval Process: Standards, Instruments, and Protocols. The process establishes standards for quality career and technical education. The population surveyed provided data on Standard Two: Curriculum and…

Redactions in protocols for drug trials: what industry sponsors concealed.

PubMed

Marquardsen, Mikkel; Ogden, Michelle; Gøtzsche, Peter C

2018-04-01

Objective To describe the redactions in contemporary protocols for industry-sponsored randomised drug trials with patient relevant outcomes and to evaluate whether there was a legitimate rationale for the redactions. Design Cohort study. Under the Freedom of Information Act, we requested access to trial protocols approved by a research ethics committee in Denmark from October 2012 to March 2013. We received 17 consecutive protocols, which had been redacted before we got them, and nine protocols without redactions. In five additional cases, the companies refused to let the committees give us access, and in three other cases, documents were missing. Participants Not applicable. Setting Not applicable. Main outcome measure Amount and nature of redactions in 22 predefined key protocol variables. Results The redactions were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials: data analysis, handling of missing data, detection and analysis of adverse events, definition of the outcomes, interim analyses and premature termination of the study, sponsor's access to incoming data while the study is running, ownership to the data and investigators' publication rights. The parts of the text that were redacted differed widely, both between companies and within the same company. Conclusions We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data.

Standardization and validation of real time PCR assays for the diagnosis of histoplasmosis using three molecular targets in an animal model.

PubMed

López, Luisa F; Muñoz, César O; Cáceres, Diego H; Tobón, Ángela M; Loparev, Vladimir; Clay, Oliver; Chiller, Tom; Litvintseva, Anastasia; Gade, Lalitha; González, Ángel; Gómez, Beatriz L

2017-01-01

Histoplasmosis is considered one of the most important endemic and systemic mycoses worldwide. Until now few molecular techniques have been developed for its diagnosis. The aim of this study was to develop and evaluate three real time PCR (qPCR) protocols for different protein-coding genes (100-kDa, H and M antigens) using an animal model. Fresh and formalin-fixed and paraffin-embedded (FFPE) lung tissues from BALB/c mice inoculated i.n. with 2.5x106 Histoplasma capsulatum yeast or PBS were obtained at 1, 2, 3, 4, 8, 12 and 16 weeks post-infection. A collection of DNA from cultures representing different clades of H. capsulatum (30 strains) and other medically relevant pathogens (36 strains of related fungi and Mycobacterium tuberculosis) were used to analyze sensitivity and specificity. Analytical sensitivity and specificity were 100% when DNAs from the different strains were tested. The highest fungal burden occurred at first week post-infection and complete fungal clearance was observed after the third week; similar results were obtained when the presence of H. capsulatum yeast cells was demonstrated in histopathological analysis. In the first week post-infection, all fresh and FFPE lung tissues from H. capsulatum-infected animals were positive for the qPCR protocols tested except for the M antigen protocol, which gave variable results when fresh lung tissue samples were analyzed. In the second week, all qPCR protocols showed variable results for both fresh and FFPE tissues. Samples from the infected mice at the remaining times post-infection and uninfected mice (controls) were negative for all protocols. Good agreement was observed between CFUs, histopathological analysis and qPCR results for the 100-kDa and H antigen protocols. We successfully standardized and validated three qPCR assays for detecting H. capsulatum DNA in fresh and FFPE tissues, and conclude that the 100-kDa and H antigen molecular assays are promising tests for diagnosing this mycosis.

29 CFR 37.64 - What procedures must the Director follow when CRC has completed a post-approval compliance review?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true What procedures must the Director follow when CRC has completed a post-approval compliance review? 37.64 Section 37.64 Labor Office of the Secretary of Labor... (WIA) Compliance Procedures § 37.64 What procedures must the Director follow when CRC has completed a...

Design and analysis of post-marketing research.

PubMed

Zhou, Xiao-Hua Andrew; Yang, Wei

2013-07-01

A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.

Normative feedback for parents of college students: piloting a parent based intervention to correct misperceptions of students' alcohol use and other parents' approval of drinking.

PubMed

Labrie, Joseph W; Napper, Lucy E; Hummer, Justin F

2014-01-01

Multi-component parent-based interventions (PBIs) provide a promising avenue for targeting alcohol use and related consequences in college students. Parents of college-aged children can have a significant influence on their children's alcohol use decisions. However, parents tend to underestimate their own child's alcohol use and overestimate other similar parents' approval of student drinking. These misperceptions could have important implications for parents' own attitudes and alcohol-related communication with their student. Targeting these misperceptions through normative feedback could help promote greater and more in-depth alcohol-related communication. The present study examines the potential efficacy of web-based alcohol-related normative feedback for parents of college students. A sample of 144 parents of college students received web-based normative feedback about students' alcohol use and approval, as well as other same-college parents' alcohol approval. Parents completed measures of perceived student alcohol use, student alcohol approval, other-parent alcohol approval, and intentions to discuss alcohol use both pre- and post-normative feedback. Post-feedback, parents reported stronger intentions to talk to their student about alcohol, were less confident in their knowledge of their students' alcohol use, and believed that their student drank in greater quantity and more frequently than pre-feedback. Parents also perceived other parents to be less approving of alcohol use after viewing normative feedback. These findings provide preliminary support for the use of web-based normative feedback for parents of college students. Given these promising results, further research developing and testing this approach merits attention. © 2013.

Pre-Activity and Post-Activity Stretching Perceptions and Practices in NCAA Division I Volleyball Programs

ERIC Educational Resources Information Center

Judge, Lawrence W.; Bodey, Kimberly J.; Bellar, David; Bottone, Adam; Wanless, Elizabeth

2010-01-01

The purpose of this study was to determine if NCAA Division I women's volleyball programs were in compliance with suggested current pre- and post-activity stretching protocols. Questionnaires were sent to NCAA division I women's volleyball programs in the United States. Fifty six coaches (23 males & 33 females) participated in the study. Some…

Dabrafenib Plus Trametinib Approved for Melanoma, Thyroid Cancer

Cancer.gov

FDA recently approved the combination of dabrafenib (Taflinar) and trametinib (Mekinist) to treat some patients with melanoma and anaplastic thyroid cancer whose tumors have a mutation in the BRAF gene. As this Cancer Currents blog post explains, this is the first treatment approved specifically for anaplastic thyroid

[Post-treatment rehabilitation after autologous chondrocyte implantation: State of the art and recommendations of the Clinical Tissue Regeneration Study Group of the German Society for Accident Surgery and the German Society for Orthopedics and Orthopedic Surgery].

PubMed

Pietschmann, M F; Horng, A; Glaser, C; Albrecht, D; Bruns, J; Scheffler, S; Marlovits, S; Angele, P; Aurich, M; Bosch, U; Fritz, J; Frosch, K H; Kolombe, T; Richter, W; Petersen, J P; Nöth, U; Niemeyer, P; Jagodzinsky, M; Kasten, P; Ruhnau, K; Müller, P E

2014-03-01

Over the course of the past two decades autologous chondrocyte implantation (ACI) has become an important surgical technique for treating large cartilage defects. The original method using a periostal flap has been improved by using cell-seeded scaffolds for implantation, the matrix-based autologous chondrocyte implantation (mb-ACI) procedure. Uniform nationwide guidelines for post-ACI rehabilitation do not exist. A survey was conducted among the members of the clinical tissue regeneration study group concerning the current rehabilitation protocols and the members of the study group published recommendations for postoperative rehabilitation and treatment after ACI based on the results of this survey. There was agreement on fundamentals concerning a location-specific rehabilitation protocol (femoral condyle vs. patellofemoral joint). With regard to weight bearing and range of motion a variety of different protocols exist. Similar to this total agreement on the role of magnetic resonance imaging (MRI) for postsurgical care was found but again a great variety of different protocols exist. This manuscript summarizes the recommendations of the members of the German clinical tissue regeneration study group on postsurgical rehabilitation and MRI assessment after ACI (level IVb/EBM).

Hypertension study in anaesthetized rabbits: protocol proposal for AT1 antagonists screening.

PubMed

Politi, Aggeliki P; Zervou, Maria V; Triantafyllidi, Helen; Zoumpoulakis, Panagiotis G; Mavromoustakos, Thomas M; Zoga, Anastasia A; Moutevelis-Minakakis, Panagiota; Kokotos, George; Iliodromitis, Efstathios K; Kremastinos, Dimitris Th

2010-06-01

The aim of this study was to establish an optimized fast and safe protocol for the pharmacological screening of AT(1) antagonists. The pharmaceutical prototype AT(1) antagonist losartan, its active metabolite EXP3174 and the synthetic compound MMK1 were analysed in order to validate the protocol. Ang II was continuously infused while the animals received the drugs in two procedures. In the post-treatment procedure drugs were administered either in a single bolus dose or in a sequential manner. When losartan was administered in a single bolus dose, efficacy was evident until the 7th min (p=0.012) whilst EXP3174 infusion extended the efficiency up to the end of the study (p=0.006). In addition, the sequential injections of losartan prolonged the inhibitory time interval until the end of the study (p=0.045). In the pre-treatment procedure, results suggested a dose-dependent inhibitory effect for both antagonists. The pressor response to Ang II was unchanged after MMK1 administration either in the post- or in the pre-treatment mode. The proposed protocol appears to be safe, simple and fast for the pharmacological screening of AT(1) antagonists and enables the evaluation of new antagonists using lower doses than any other reported in the literature.

Development of Uniform Protocol for Alopecia Areata Clinical Trials.

PubMed

Solomon, James A

2015-11-01

Developing a successful treatment for alopecia areata (AA), clearly has not been at the forefront of the agenda for new drug/device development among the pharmaceutical and medical device industry. The National Alopecia Areata Foundation (NAAF), a patient advocacy group, initiated a plan to facilitate and drive clinical research toward finding safe and efficacious treatments for AA. As such, Alopecia Areata Uniform Protocols for clinical trials to test new treatments for AA were developed. The design of the uniform protocol is to accomplish the development of a plug-and-play template as well as to provide a framework wherein data from studies utilizing the uniform protocol can be compared through consistency of inclusions/exclusions, safety, and outcome assessment measures. A core uniform protocol for use by pharmaceutical companies in testing proof of concept for investigational products to treat AA. The core protocol includes standardized title, informed consent, inclusion/exclusion criteria, disease outcome assessments, and safety assessments. The statistical methodology to assess successful outcomes will also be standardized. The protocol as well as the informed consent form has been approved in concept by Liberty IRB and is ready to present to pharmaceutical companies.

Partner approval and intention to use contraception among Zanzibari women presenting for post-abortion care.

PubMed

Esber, Allahna; Foraker, Randi E; Hemed, Maryam; Norris, Alison

2014-07-01

We examined the effect of partner approval of contraception on intention to use contraception among women obtaining post-abortion care in Zanzibar. Our data source was a 2010 survey of 193 women obtaining post-abortion care at a large public hospital in Zanzibar. We used multivariable logistic regression analysis to assess associations between partner approval and intention to use contraception. Overall, 23% of participants had used a contraceptive method in the past, and 66% reported intending to use contraception in the future. We found that partner approval of contraception and ever having used contraception in the past were each associated with intending to use contraception in the future. In the multivariable model, adjusting for past contraception use, partner approval of contraception was associated with 20 times the odds of intending to use contraception (odds ratio, 20.25; 95% confidence interval, 8.45-48.56). We found a strong association between partner approval and intention to use contraception. Efforts to support contraceptive use must include both male and female partners. Public health and educational efforts to increase contraceptive use must include men and be targeted to both male and female partners. Given that male partners are often not present when women obtain health care, creative efforts will be required to meet men in community settings. Copyright © 2014 Elsevier Inc. All rights reserved.

Post-radiosynovectomy imaging of Er-169 using scintigraphy and autoradiography.

PubMed

Farahati, Jamshid; Elliott, Johanna; Höppner, Sabrina; Stein, Linda; Gilman, Elena; Kumm, Dietmar; Grodotzki, Thomas

2017-06-01

Currently, there is no protocol for the detection of intra-articular distribution of Er-169 citrate after radiosynovectomy. We propose post-therapeutic imaging using scintigraphy and cobalt-57 pen-marker autoradiography. This technique evaluates the efficacy of the radiosynovectomy and patient safety and could be utilized for dosimetric protocol.

34 CFR 462.3 - What definitions apply?

Code of Federal Regulations, 2012 CFR

2012-07-01

... items across pre- and post-testing. Test administrator means an individual who is trained to administer... instructional time a student needs before post-testing. Violation of these protocols often invalidates the test... defined in the Act. Test means a standardized test, assessment, or instrument that has a formal protocol...

34 CFR 462.3 - What definitions apply?

Code of Federal Regulations, 2010 CFR

2010-07-01

... items across pre- and post-testing. Test administrator means an individual who is trained to administer... instructional time a student needs before post-testing. Violation of these protocols often invalidates the test... defined in the Act. Test means a standardized test, assessment, or instrument that has a formal protocol...

34 CFR 462.3 - What definitions apply?

Code of Federal Regulations, 2011 CFR

2011-07-01

... items across pre- and post-testing. Test administrator means an individual who is trained to administer... instructional time a student needs before post-testing. Violation of these protocols often invalidates the test... defined in the Act. Test means a standardized test, assessment, or instrument that has a formal protocol...

34 CFR 462.3 - What definitions apply?

Code of Federal Regulations, 2014 CFR

2014-07-01

... items across pre- and post-testing. Test administrator means an individual who is trained to administer... instructional time a student needs before post-testing. Violation of these protocols often invalidates the test... defined in the Act. Test means a standardized test, assessment, or instrument that has a formal protocol...

34 CFR 462.3 - What definitions apply?

Code of Federal Regulations, 2013 CFR

2013-07-01

... items across pre- and post-testing. Test administrator means an individual who is trained to administer... instructional time a student needs before post-testing. Violation of these protocols often invalidates the test... defined in the Act. Test means a standardized test, assessment, or instrument that has a formal protocol...

Regional Anesthesia and Valproate Sodium for the Prevention of Chronic Post-Amputation Pain

DTIC Science & Technology

2014-10-01

and meetings with VAMC nursing and all study personnel while awaiting CRADA approval from VAMC NOVEMBER Duke/VA CRADA approved; start of enrollment at...Duke patient enrollment MAY Numerous meetings at Duke (Investigational Drug Service, Limb Loss Clinical Nurse Specialist, in-patient team) to discuss...Dionne Apedjihoun, CRC met with Nancy Payne, Duke Clinical Nurse /Limb Loss Specialist to trouble shoot potential patient recruitment for in and out

25 years of Eye Movement Desensitization and Reprocessing (EMDR): The EMDR therapy protocol, hypotheses of its mechanism of action and a systematic review of its efficacy in the treatment of post-traumatic stress disorder.

PubMed

Novo Navarro, Patricia; Landin-Romero, Ramón; Guardiola-Wanden-Berghe, Rocio; Moreno-Alcázar, Ana; Valiente-Gómez, Alicia; Lupo, Walter; García, Francisca; Fernández, Isabel; Pérez, Víctor; Amann, Benedikt L

Eye movement desensitization and reprocessing (EMDR) is a relatively new psychotherapy that has gradually gained popularity for the treatment of post-traumatic stress disorder. In the present work, the standardised EMDR protocol is introduced, along with current hypotheses of its mechanism of action, as well as a critical review of the available literature on its clinical effectiveness in adult post-traumatic stress disorder. A systematic review of the published literature was performed using PubMed and PsycINFO databases with the keywords «eye movement desensitization and reprocessing» and «post-traumatic stress disorder» and its abbreviations «EMDR» and «PTSD». Fifteen randomised controlled trials of good methodological quality were selected. These studies compared EMDR with unspecific interventions, waiting lists, or specific therapies. Overall, the results of these studies suggest that EMDR is a useful, evidence-based tool for the treatment of post-traumatic stress disorder, in line with recent recommendations from different international health organisations. Copyright © 2016 SEP y SEPB. Publicado por Elsevier España, S.L.U. All rights reserved.

Ear Acupuncture for Post-Operative Pain Associated with Ambulatory Arthroscopic Knee Surgery: A Randomized Controlled Trial

DTIC Science & Technology

2014-01-14

E7(/(3+21(180%(5 ,QFOXGHDUHDFRGH 14 Jan 2014 Final Report Ear acupuncture for post-operative pain associated with ambulatory arthroscopic...DISTRIBUTION A. Approved for public release: distribution unlimited. The purpose of this study is to compare ear acupuncture plus standard therapy versus...3298 Ear Acupuncture for Post-operative Pa111 Assoc1ated With Ambulatory Arthroscopic Knee Surgery A Randomized Controlled Trial ’• V ’’ ’-’ I

Permissive weight bearing in trauma patients with fracture of the lower extremities: prospective multicenter comparative cohort study.

PubMed

Kalmet, Pishtiwan H S; Meys, Guido; V Horn, Yvette Y; Evers, Silvia M A A; Seelen, Henk A M; Hustinx, Paul; Janzing, Heinrich; Vd Veen, Alexander; Jaspars, Coen; Sintenie, Jan Bernard; Blokhuis, Taco J; Poeze, Martijn; Brink, Peter R G

2018-02-02

The standard aftercare treatment in surgically treated trauma patients with fractures around or in a joint, known as (peri)- or intra-articular fractures of the lower extremities, is either non-weight bearing or partial weight bearing. We have developed an early permissive weight bearing post-surgery rehabilitation protocol in surgically treated patients with fractures of the lower extremities. In this proposal we want to compare our early permissive weight bearing protocol to the existing current non-weight bearing guidelines in a prospective comparative cohort study. The study is a prospective multicenter comparative cohort study in which two rehabilitation aftercare treatments will be contrasted, i.e. permissive weight bearing and non-weight bearing according to the AO-guideline. The study population consists of patients with a surgically treated fracture of the pelvis/acetabulum or a surgically treated (peri)- or intra-articular fracture of the lower extremities. The inclusion period is 12 months. The duration of follow up is 6 months, with measurements taken at baseline, 2,6,12 and 26 weeks post-surgery. ADL with Lower Extremity Functional Scale. Outcome variables for compliance, as measured with an insole pressure measurement system, encompass peak load and step duration. This study will investigate the (cost-) effectiveness of a permissive weight bearing aftercare protocol. The results will provide evidence whether a permissive weight bearing protocol is more effective than the current non-weight bearing protocol. The study is registered in the Dutch Trial Register ( NTR6077 ). Date of registration: 01-09-2016.

Acupuncture for post anaesthetic recovery and postoperative pain: study protocol for a randomised controlled trial.

PubMed

Fleckenstein, Johannes; Baeumler, Petra I; Gurschler, Caroline; Weissenbacher, Tobias; Simang, Michael; Annecke, Thorsten; Geisenberger, Thomas; Irnich, Dominik

2014-07-21

We report on the design and implementation of a study protocol entitled Acupuncture randomised trial for post anaesthetic recovery and postoperative pain - a pilot study (ACUARP) designed to investigate the effectiveness of acupuncture therapy performed in the perioperative period on post anaesthetic recovery and postoperative pain. The study is designed as a randomised controlled pilot trial with three arms and partial double blinding. We will compare (a) press needle acupuncture, (b) no treatment and (c) press plaster acupressure in a standardised anaesthetic setting. Seventy-five patients scheduled for laparoscopic surgery to the uterus or ovaries will be allocated randomly to one of the three trial arms. The total observation period will begin one day before surgery and end on the second postoperative day. Twelve press needles and press plasters are to be administered preoperatively at seven acupuncture points. The primary outcome measure will be time from extubation to 'ready for discharge' from the post anaesthesia care unit (in minutes). The 'ready for discharge' end point will be assessed using three different scores: the Aldrete score, the Post Anaesthetic Discharge Scoring System and an In-House score. Secondary outcome measures will comprise pre-, intra- and postoperative variables (which are anxiety, pain, nausea and vomiting, concomitant medication). The results of this study will provide information on whether acupuncture may improve patient post anaesthetic recovery. Comparing acupuncture with acupressure will provide insight into potential therapeutic differences between invasive and non-invasive acupuncture techniques. NCT01816386 (First received: 28 October 2012).

Improving the consistency in cervical esophageal target volume definition by special training.

PubMed

Tai, Patricia; Van Dyk, Jake; Battista, Jerry; Yu, Edward; Stitt, Larry; Tonita, Jon; Agboola, Olusegun; Brierley, James; Dar, Rashid; Leighton, Christopher; Malone, Shawn; Strang, Barbara; Truong, Pauline; Videtic, Gregory; Wong, C Shun; Wong, Rebecca; Youssef, Youssef

2002-07-01

Three-dimensional conformal radiation therapy requires the precise definition of the target volume. Its potential benefits could be offset by the inconsistency in target definition by radiation oncologists. In a previous survey of radiation oncologists, a large degree of variation in target volume definition of cervical esophageal cancer was noted for the boost phase of radiotherapy. The present study evaluated whether special training could improve the consistency in target volume definitions. A pre-training survey was performed to establish baseline values. This was followed by a special one-on-one training session on treatment planning based on the RTOG 94-05 protocol to 12 radiation oncologists. Target volumes were redrawn immediately and at 1-2 months later. Post-training vs. pre-training target volumes were compared. There was less variability in the longitudinal positions of the target volumes post-training compared to pre-training (p < 0.05 in 5 of 6 comparisons). One case had more variability due to the lack of a visible gross tumor on CT scans. Transverse contours of target volumes did not show any significant difference pre- or post-training. For cervical esophageal cancer, this study suggests that special training on protocol guidelines may improve consistency in target volume definition. Explicit protocol directions are required for situations where the gross tumor is not easily visible on CT scans. This may be particularly important for multicenter clinical trials, to reduce the occurrences of protocol violations.

MANEMO Routing in Practice: Protocol Selection, Expected Performance, and Experimental Evaluation

NASA Astrophysics Data System (ADS)

Tazaki, Hajime; van Meter, Rodney; Wakikawa, Ryuji; Wongsaardsakul, Thirapon; Kanchanasut, Kanchana; Dias de Amorim, Marcelo; Murai, Jun

Motivated by the deployment of post-disaster MANEMO (MANET for NEMO) composed of mobile routers and stations, we evaluate two candidate routing protocols through network simulation, theoretical performance analysis, and field experiments. The first protocol is the widely adopted Optimized Link State Routing protocol (OLSR) and the second is the combination of the Tree Discovery Protocol (TDP) with Network In Node Advertisement (NINA). To the best of our knowledge, this is the first time that these two protocols are compared in both theoretical and practical terms. We focus on the control overhead generated when mobile routers perform a handover. Our results confirm the correctness and operational robustness of both protocols. More interestingly, although in the general case OLSR leads to better results, TDP/NINA outperforms OLSR both in the case of sparse networks and in highly mobile networks, which correspond to the operation point of a large set of post-disaster scenarios.

Procedural trends, outcomes, and readmission rates pre-and post-FDA approval for MitraClip from the National Readmission Database (2013-14).

PubMed

Panaich, Sidakpal S; Arora, Shilpkumar; Badheka, Apurva; Kumar, Varun; Maor, Elad; Raphael, Claire; Deshmukh, Abhishek; Reeder, Guy; Eleid, Mackram; Rihal, Charanjit S

2018-05-01

There are sparse clinical data on the procedural trends, outcomes and readmission rates following FDA approval and expansion of Transcatheter mitral valve repair/MitraClip ® . Whether a complex new technology can be disseminated safely and quickly is controversial. The study cohort was derived from the National Readmission Data (NRD) 2013-14. MitraClip ® was identified using appropriate International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes. The primary outcome was a composite of in-hospital mortality + procedural complications. Secondary outcome included 30-day readmissions. Hierarchical two level logistic models were used to evaluate study outcomes. Our analysis included 2003 MitraClip ® procedures. Overall in-hospital mortality was 3.9%. As expected, there was a significant increase in procedural volume post-FDA approval. Importantly, a corresponding downward trend in mortality and procedural complications was observed. Significant predictors of in-hospital mortality and procedural complications included the use of vasopressors (P <0.001) and hemodynamic support (P < 0.001). Higher hospital volume (≥10 MitraClips/year) was associated with lower in-hospital mortality and complications (P = 0.02). There were 304 (15.1%) 30-day readmissions, with heart failure being the most common cause of readmission. Elective procedures had lower in-hospital mortality (P < 0.001) and lower readmission rates (P = 0.011) compared with nonelective procedures. A significant increase in MitraClip ® procedural volumes occurred post-FDA approval. Overall morbidity and mortality were low and trended downwards. Hospital procedure volume ≥10 cases were associated with lower mortality and overall complication rates. These data suggest a successful roll out of a very complex novel structural heart procedure. © 2017 Wiley Periodicals, Inc.

38 CFR 21.9765 - Program of education approval.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false Program of education... (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approval of Programs of Education § 21.9765 Program of education approval. VA may provide educational assistance for pursuit of a program of...

38 CFR 21.9765 - Program of education approval.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false Program of education... (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approval of Programs of Education § 21.9765 Program of education approval. VA may provide educational assistance for pursuit of a program of...

38 CFR 21.9765 - Program of education approval.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 false Program of education... (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approval of Programs of Education § 21.9765 Program of education approval. VA may provide educational assistance for pursuit of a program of...

38 CFR 21.9765 - Program of education approval.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false Program of education... (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approval of Programs of Education § 21.9765 Program of education approval. VA may provide educational assistance for pursuit of a program of...

38 CFR 21.9765 - Program of education approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Program of education... (CONTINUED) VOCATIONAL REHABILITATION AND EDUCATION Post-9/11 GI Bill Approval of Programs of Education § 21.9765 Program of education approval. VA may provide educational assistance for pursuit of a program of...

Participant acceptability of exercise in kidney disease (PACE-KD): a feasibility study protocol in renal transplant recipients

PubMed Central

Bishop, Nicolette C; Billany, Roseanne; Smith, Alice C

2017-01-01

Introduction Cardiovascular disease (CVD) is a major cause of mortality in renal transplant recipients (RTRs). General population risk scores for CVD underestimate the risk in patients with chronic kidney disease (CKD) suggesting additional non-traditional factors. Renal transplant recipients also exhibit elevated inflammation and impaired immune function. Exercise has a positive impact on these factors in patients with CKD but there is a lack of rigorous research in RTRs, particularly surrounding the feasibility and acceptability of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) in this population. This study aims to explore the feasibility of three different supervised aerobic exercise programmes in RTRs to guide the design of future large-scale efficacy studies. Methods and analysis Renal transplant recipients will be randomised to HIIT A (16 min interval training with 4, 2 and 1 min intervals at 80%–90% of peak oxygen uptake (VO2 peak)), HIIT B (4×4 min interval training at 80%–90% VO2peak) or MICT (~40 min cycling at 50%–60% VO2peak) where they will undertake 24 supervised sessions (approximately thrice weekly over 8 weeks). Assessment visits will be at baseline, midtraining, immediate post-training and 3 months post-training. The study will evaluate the feasibility of recruitment, randomisation, retention, assessment procedures and the implementation of the interventions. A further qualitative sub-study QPACE-KD (Qualitative Participant Acceptability of Exercise in Kidney Disease) will explore patient experiences and perspectives through semistructured interviews and focus groups. Ethics and dissemination All required ethical and regulatory approvals have been obtained. Findings will be disseminated through conference presentations, public platforms and academic publications. Trial registration number Prospectively registered; ISRCTN17122775. PMID:28947458

Assessment tools for the measurement of the self-efficacy of drug users: protocol for a systematic review

PubMed Central

Vasconcelos, Selene Cordeiro; Frazão, Iracema da Silva; Sougey, Everton Botelho; de Souza, Sandra Lopes; da Silva, Tatiana de Paula Santana; Lima, Murilo Duarte da Costa

2018-01-01

Introduction The abuse of alcohol and other drugs is a worldwide problem, the treatment of which poses a challenge to healthcare workers. Objective This study presents a proposal for a systematic review to analyse the psychometric properties of assessment tools developed to measure the self-efficacy of drug users with regard to resisting the urge to take drugs in high-risk situations. Methods and Analysis The guiding question was based on PICOS (Population Intervention Comparator Outcome Setting), and the report of the methods of review protocol was written in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Searches will be performed in the PsycINFO, Cochrane, Pubmed, Web of Science, SCOPUS and CINAHL databases, followed by the use of the ‘snowball’ strategy. The inclusion criteria for the articles will be (1) assessment tool validation studies; (2) assessment tools developed to measure self-efficacy; (3) quantitative measures; (4) measures designed for use on adults; (5) data from self-reports of the participants; (6) studies involving a description of psychometric properties of the measures; and (7) studies that explain how the level of self-efficacy is scored. The search, selection and analysis will be performed by two independent reviewers. In cases of a divergence of opinion, a third reviewer will be consulted. The COSMIN checklist will be used for the appraisal of the methodological quality of the assessment tools and the certainty of the evidence in the articles (risk of bias) will be analysed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Ethics and dissemination This protocol does not require ethical approval. However, this protocol is part of the thesis entitled Drug-Taking Confidence Questionnaire for use in Brazil, presented for obtaining a doctorate in neuropsychiatry and behavioural sciences from the Federal University of Pernambuco, and has received approval from the human research ethics committee of the Federal University of Pernambuco (reference number: 1.179.162). The results will be disseminated to clinicians and researchers through peer-reviewed publications and conferences. PROSPERO registration number CRD42017068555. PMID:29540409

Post-exertion neurocognitive test failure among student-athletes following concussion.

PubMed

McGrath, Neal; Dinn, Wayne M; Collins, Michael W; Lovell, Mark R; Elbin, R J; Kontos, Anthony P

2013-01-01

The purpose of the present study was to examine post-exertion (PE) neurocognitive performance among student-athletes following concussion who were asymptomatic and returned to baseline normal neurocognitive test levels at rest. This study examined the neurocognitive performance of a sub-set of student-athletes who 'failed' to perform at baseline levels of neurocognitive function, i.e. exhibited downward reliable change index (RCI) alterations following a moderate exertional protocol during recovery from concussion. A retrospective records review was carried out of Immediate Post-concussion Assessment and Cognitive Testing (ImPACT) and neuropsychological consultation data among athletes with sports-related concussion from a network of 22 schools and one junior hockey programme. Fifty-four student-athletes met inclusion criteria and participated in the study. A total of 27.7% of concussed student-athletes who were symptom-free and returned to baseline on ImPACT at rest (i.e. no longer demonstrated performance deficits on neurocognitive tests) exhibited cognitive decline following moderate physical exertion. The PE cognitive changes were not simply general performance effects, but significant changes in memory ability in the presence of intact processing speed functions. The PE-Pass and PE-Fail groups did not, however, differ on post-concussive symptoms or concussion history. Clinicians' return-to-play evaluation protocols should include post-exertional computerized neurocognitive testing.

Nucleophilic substitution reaction for post-functionalization of polyoxometalates

DOE PAGES

Yin, Panchao; Li, Qiang; Zhang, Jin; ...

2015-07-06

In this study, a hexamolybdate-based organic inorganic hybrid molecule containing a chloralkane fragment is synthesized and its Cl atom can be substituted by iodine and nitrate through nucleophilic substitution reactions in high yields, which provide a post-functionalization protocol to bring in various additional functional groups into polyoxometalate-based hybrid materials under mild conditions.

Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico

PubMed Central

Cornejo Vucovich, Elsa; Ingram, Maia; Valenica, Celina; Castro Vasquez, Maria del Carmen; Gonzalez-Fagoaga, Eduardo; Geurnsey de Zapien, Jill

2018-01-01

Introduction Northern Mexico has among the highest rates of cardiovascular disease (CVD) and diabetes in the world. This research addresses core gaps in implementation science to develop, test and scale-up CVD risk-reduction interventions in diabetics through a national primary care health system. Methods and analysis The Meta Salud Diabetes (MSD) research project is a parallel two-arm cluster-randomised clinical behavioural trial based in 22 (n=22) health centres in Sonora, Mexico. MSD aims to evaluate the effectiveness of the MSD intervention for the secondary prevention of CVD risk factors among a diabetic population (n=320) compared with the study control of usual care. The MSD intervention consists of 2-hour class sessions delivered over a 13-week period providing educational information to encourage sustainable behavioural change to prevent disease complications including the adoption of physical activity. MSD is delivered within the context of Mexico’s national primary care health centre system by health professionals, including nurses, physicians and community health workers via existing social support groups for individuals diagnosed with chronic disease. Mixed models are used to estimate the effect of MSD by comparing cardiovascular risk, as measured by the Framingham Risk Score, between the trial arms. Secondary outcomes include hypertension, behavioural risk factors and psychosocial factors. Ethics and dissemination This work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (1R01HL125996-01) and approved by the University of Arizona Research Institutional Review Board (Protocol 1508040144) and the Research Bioethics Committee at the University of Sonora. The first Internal Review Board approval date was 31 August 2015 with five subsequent approved amendments. This article refers to protocol V.0.2, dated 30 January 2017. Results will be disseminated via peer-reviewed publication and presentation at international conferences and will be shared through meetings with health systems officials. Trial registration number NCT0280469; Pre-results. PMID:29530914

Needlestick and Sharps Injuries in Dermatologic Surgery: A Review of Preventative Techniques and Post-exposure Protocols

PubMed Central

Monroe, Holly; Orengo, Ida; Rosen, Theodore

2016-01-01

Background: Needlestickand sharps injuries are the leading causes of morbidity in the dermatologicfield. Among medical specialties, surgeons and dermatologists have the highest rates of needlestickand sharps injuries.The high rates of needlestickand sharps injuries in dermatology not only apply to physicians, but also to nurses, physician assistants, and technicians in the demnatologic field. Needlestickand sharps injuries are of great concern due to the monetary, opportunity, social, and emotional costs associated with their occurrence. Objective: A review of preventative techniques and post-exposure protocols for the majortypes of sharps injuries encountered in dermatologic practice. Design: The terms “needle-stick injuryT’sharps injuryTdermatologic surgery? “post-exposure prophylaxis,”and “health-care associated injury” were used in combinations to search the PubMed database. Relevant studies were reviewed for validity and included. Results The authors discuss the major types of sharps injuries that occur in the dermatologic surgery setting and summarize preventative techniques with respect to each type of sharps injury.The authors also summarize and discuss relevant post-exposure protocols in the event of a sharps injury. Conclusion: The adoption of the discussed methods, techniques, practices, and attire can result in the elimination of the vast majority of dermatologic sharps injuries. PMID:27847548

Protocol Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive clinical and administrative support to the National Cancer Institute’s Center for Cancer Research’s (CCR) Protocol Support Office (PSO) for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration. KEY ROLES/RESPONSIBILITIES The Protocol Coordinator III: Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials. Provides deployment of clinical support services for clinical research. Streamlines the protocol development timeline. Provides data and documents collection and compilation for regulatory filing with the U.S. Food and Drug Administration (FDA) and other regulatory authorities.. Provides technical review and report preparation. Provides administrative coordination and general logistical support for regulatory activities. Ensures the provision of training for investigators and associate staff to reinforce and enhance a Good Clinical Practices (GCP) culture. Oversees quality assurance and quality control, performs regulatory review of clinical protocols, informed consent and other clinical documents. Tracks and facilitates a portfolio of protocols through each process step (Institutional Review Board [IRB], Regulatory Affairs Compliance [RAC], Data Safety Monitoring Board [DSMB], Office of Protocol Services). Assists clinical investigators in preparing clinical research protocols, including writing and formatting consent forms. Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with CCR, NCI and NIH policies. Collaborates with investigators to resolve any protocol/data issues. Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI IRB, and the clinical trial sponsor or the FDA. Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events. Attends and prepares minutes for the Branch Protocol Review Committees. Contacts coordinators at other centers for protocols that are performed there to obtain review committee approvals at those centers, maintains records of these approvals and sends protocol amendments and other reports to the participating centers. Maintains a schedule of all review committee submission deadline dates and meeting dates. Assists clinical investigators in understanding and complying with the entire review process. Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document and tracking system for NCI protocols. Converts protocols from Word format to .pdf with bookmarks. Maintains the .pdf version of the most current approved version of each active clinical protocol on a central server. This position is located in Rockville, Maryland.

Evaluation of HRV Biofeedback as a Resilience Building Reserve Component

DTIC Science & Technology

2017-08-01

Inventions, patent applications, and/or licenses Nothing to report  Other Products  Study recruitment/announcement video  Mobile app for...International Award Amount: $1,833,144 Study / Product Aim(s) 1. Develop and test the PHIT platform for use with the BART protocol. 2. Examine...STATEMENT Approved for Public Release; Distribution Unlimited 13. SUPPLEMENTARY NOTES 14. ABSTRACT The specific aims of this study are to (1) develop a

The Pharmacokinetics and Efficacy of a Low-dose, Aqueous, Intranasal Scopolamine Spray

DTIC Science & Technology

2017-09-27

In this study , we found no correlation between plasma levels at any time point and the number of head tilts tolerated. However, there was a positive... study protocol was approved by the Naval Medical Research Unit Dayton Institutional Review Board in compliance with all applicable Federal...The study examined both the pharmacokinetic properties and efficacy of a low-dose, aqueous, intranasal scopolamine spray (INSCOP) as an anti-motion

Study of Tranexamic Acid During Air Medical Prehospital Transport Trial (STAAMP trial)

DTIC Science & Technology

2015-10-01

AWARD NUMBER: W81XWH-13-2-0080 TITLE: Study of Tranexamic Acid During Air Medical Prehospital Transport Trial (STAAMP trial) PRINCIPAL INVESTIGATOR...TITLE AND SUBTITLE 5a. CONTRACT NUMBER Study of Tranexamic Acid During Air Medical Prehospital Transport Trial (STAAMP trial) 5b. GRANT NUMBER W81XWH...IRB approval regarding changes to the protocol language. 15. SUBJECT TERMS Prehospital; Tranexamic acid 16. SECURITY CLASSIFICATION OF: 17. LIMITATION

An individualised risk-adapted protocol of pre- and post transplant zoledronic acid reduces bone loss after allogeneic stem cell transplantation: results of a phase II prospective trial.

PubMed

Grigg, A; Butcher, B; Khodr, B; Bajel, A; Hertzberg, M; Patil, S; D'Souza, A B; Ganly, P; Ebeling, P; Wong, E

2017-09-01

Bone loss occurs frequently following allogeneic haematopoietic stem cell transplantation (alloSCT). The Australasian Leukaemia and Lymphoma Group conducted a prospective phase II study of pretransplant zoledronic acid (ZA) and individualised post-transplant ZA to prevent bone loss in alloSCT recipients. Patients received ZA 4 mg before conditioning. Administration of post-transplant ZA from days 100 to 365 post alloSCT was determined by a risk-adapted algorithm based on serial bone density assessments and glucocorticoid exposure. Of 82 patients enrolled, 70 were alive and without relapse at day 100. A single pretransplant dose of ZA prevented femoral neck bone loss at day 100 compared with baseline (mean change -2.6±4.6%). Using the risk-adapted protocol, 42 patients received ZA between days 100 and 365 post alloSCT, and this minimised bone loss at day 365 compared with pretransplant levels (mean change -2.9±5.3%). Femoral neck bone loss was significantly reduced in ZA-treated patients compared with historical untreated controls at days 100 and 365. This study demonstrates that a single dose of ZA pre-alloSCT prevents femoral neck bone loss at day 100 post alloSCT, and that a risk-adapted algorithm is able to guide ZA administration from days 100 to 365 post transplant and minimise further bone loss.

The impact of a chest tube management protocol on the outcome of trauma patients with tube thoracostomy.

PubMed

de Abreu, Emanuelle Maria Sávio; Machado, Carla Jorge; Pastore Neto, Mario; de Rezende Neto, João Baptista; Sanches, Marcelo Dias

2015-01-01

to investigate the effect of standardized interventions in the management of tube thoracostomy patients and to assess the independent effect of each intervention. A chest tube management protocol was assessed in a retrospective cohort study. The tube thoracostomy protocol (TTP) was implemented in August 2012, and consisted of: antimicrobial prophylaxis, chest tube insertion in the operating room (OR), admission post chest tube thoracostomy (CTT) in a hospital floor separate from the emergency department (ED), and daily respiratory therapy (RT) sessions post-CTT. The inclusion criteria were, hemodynamic stability, patients between the ages of 15 and 59 years, and injury severity score (ISS) < 17. All patients had isolated injuries to the chest wall, lung, and pleura. During the study period 92 patients were managed according to the standardized protocol. The outcomes of those patients were compared to 99 patients treated before the TTP. Multivariate logistic regression analysis was performed to assess the independent effect of each variable of the protocol on selected outcomes. Demographics, injury severity, and trauma mechanisms were similar among the groups. As expected, protocol compliance increased after the implementation of the TTP. There was a significant reduction (p<0.05) in the incidence of retained hemothoraces, empyemas, pneumonias, surgical site infections, post-procedural complications, hospital length of stay, and number of chest tube days. Respiratory therapy was independently linked to significant reduction (p<0.05) in the incidence of seven out of eight undesired outcomes after CTT. Antimicrobial prophylaxis was linked to a significant decrease (p<0.05) in retained hemothoraces, despite no significant (p<0.10) reductions in empyema and surgical site infections. Conversely, OR chest tube insertion was associated with significant (p<0.05) reduction of both complications, and also significantly decreased the incidence of pneumonias. Implementation of a TTP effectively reduced complications after CTT in trauma patients.

Multivariate Analysis of High Through-Put Adhesively Bonded Single Lap Joints: Experimental and Workflow Protocols

DTIC Science & Technology

2016-06-01

unlimited. v List of Tables Table 1 Single-lap-joint experimental parameters ..............................................7 Table 2 Survey ...Joints: Experimental and Workflow Protocols by Robert E Jensen, Daniel C DeSchepper, and David P Flanagan Approved for...TR-7696 ● JUNE 2016 US Army Research Laboratory Multivariate Analysis of High Through-Put Adhesively Bonded Single Lap Joints: Experimental

A Retrospective Analysis of Pre-surgical Incisor Decompensation Attained in an Orthognathic Surgery Population

DTIC Science & Technology

2016-07-01

owner. ~ GARY S. MAYNE, Maj, USAF, DC Tri-Service Orthodontic Residency Program Air Force Post Graduate Dental School Uniformed Services University...APPROVED: __________________________________________ Drew W. Fallis, D.D.S., M.S., Dean, Air Force Post-Graduate Dental School iii...Air Force Postgraduate Dental School, Joint Base San Antonio-Lackland, San Antonio, Texas, USA). Inclusion criteria for the study were 1

A service protocol for post-processing of medical images on the mobile device

NASA Astrophysics Data System (ADS)

He, Longjun; Ming, Xing; Xu, Lang; Liu, Qian

2014-03-01

With computing capability and display size growing, the mobile device has been used as a tool to help clinicians view patient information and medical images anywhere and anytime. It is uneasy and time-consuming for transferring medical images with large data size from picture archiving and communication system to mobile client, since the wireless network is unstable and limited by bandwidth. Besides, limited by computing capability, memory and power endurance, it is hard to provide a satisfactory quality of experience for radiologists to handle some complex post-processing of medical images on the mobile device, such as real-time direct interactive three-dimensional visualization. In this work, remote rendering technology is employed to implement the post-processing of medical images instead of local rendering, and a service protocol is developed to standardize the communication between the render server and mobile client. In order to make mobile devices with different platforms be able to access post-processing of medical images, the Extensible Markup Language is taken to describe this protocol, which contains four main parts: user authentication, medical image query/ retrieval, 2D post-processing (e.g. window leveling, pixel values obtained) and 3D post-processing (e.g. maximum intensity projection, multi-planar reconstruction, curved planar reformation and direct volume rendering). And then an instance is implemented to verify the protocol. This instance can support the mobile device access post-processing of medical image services on the render server via a client application or on the web page.

A protocol for coordinating post-tsunami field reconnaissance efforts in the USA

USGS Publications Warehouse

Wilson, Rick I.; Wood, Nathan J.; Kong, Laura; Shulters, Michael V.; Richards, Kevin D.; Dunbar, Paula; Tamura, Gen; Young, Edward J.

2015-01-01

In the aftermath of a catastrophic tsunami, much is to be learned about tsunami generation and propagation, landscape and ecological changes, and the response and recovery of those affected by the disaster. Knowledge of the impacted area directly helps response and relief personnel in their efforts to reach and care for survivors and for re-establishing community services. First-hand accounts of tsunami-related impacts and consequences also help researchers, practitioners, and policy makers in other parts of the world that lack recent events to better understand and manage their own societal risks posed by tsunami threats. Conducting post-tsunami surveys and disseminating useful results to decision makers in an effective, efficient, and timely manner is difficult given the logistical issues and competing demands in a post-disaster environment. To facilitate better coordination of field-data collection and dissemination of results, a protocol for coordinating post-tsunami science surveys was developed by a multi-disciplinary group of representatives from state and federal agencies in the USA. This protocol is being incorporated into local, state, and federal post-tsunami response planning through the efforts of the Pacific Risk Management ‘Ohana, the U.S. National Tsunami Hazard Mitigation Program, and the U.S. National Plan for Disaster Impact Assessments. Although the protocol was designed to support a coordinated US post-tsunami response, we believe it could help inform post-disaster science surveys conducted elsewhere and further the discussion on how hazard researchers can most effectively operate in disaster environments.

Prevention and treatment of hand oedema after stroke.

PubMed

Kuppens, Stefanie P M; Pijlman, Hanneke C P; Hitters, Minou W M G C; van Heugten, Caroline M

2014-01-01

As there is no evidence for a specific treatment for post-stroke-induced hand oedema, rehabilitation centre Blixembosch formalized a best practice protocol. We investigated whether the Blixembosch hand oedema protocol is usable in daily practice and leads to lower incidence (prevention) and shorter duration (treatment) compared with care as usual. In a non-randomised comparative trial, we investigated 206 post-stroke patients admitted to two Dutch rehabilitation centres. Hand volumes were measured at least bi-weekly using a volumeter. Treatment was started according the protocol (Blixembosch) or following care as usual (Leijpark). Usability was assessed with a survey among professionals. In the Blixembosch group, 16% developed oedema after admission, compared with 21% in the control group (p = 0.019). Average duration of oedema (both developed before and after admission) was 6.5 weeks in the Blixembosch group compared with 3.1 weeks in the control group (p = 0.000). Professionals were positive about the protocol. The study showed that the protocol is usable in daily practice and has a small beneficial effect on hand oedema incidence rates compared with care as usual. The negative effect on duration of hand oedema could also be caused by the difference in prognosis between the two groups.

Hip arthroscopy protocol: expert opinions on post-operative weight bearing and return to sports guidelines.

PubMed

Rath, Ehud; Sharfman, Zachary T; Paret, Matan; Amar, Eyal; Drexler, Michael; Bonin, Nicolas

2017-01-01

The objectives of this study are to survey the weight-bearing limitation practices and delay for returning to running and impact sports of high volume hip arthroscopy orthopedic surgeons. The study was designed in the form of expert survey questionnaire. Evidence-based data are scares regarding hip arthroscopy post-operative weight-bearing protocols. An international cross-sectional anonymous Internet survey of 26 high-volume hip arthroscopy specialized surgeons was conducted to report their weight-bearing limitations and rehabilitation protocols after various arthroscopic hip procedures. The International Society of Hip Arthroscopy invited this study. The results were examined in the context of supporting literature to inform the studies suggestions. Four surgeons always allow immediate weight bearing and five never offer immediate weight bearing. Seventeen surgeons provide weight bearing depending on the procedures performed: 17 surgeons allowed immediate weight bearing after labral resection, 10 after labral repair and 8 after labral reconstruction. Sixteen surgeons allow immediate weight bearing after psoas tenotomy. Twenty-one respondents restrict weight bearing after microfracture procedures for 3-8 weeks post-operatively. Return to running and impact sports were shorter for labral procedures and bony procedures and longer for cartilaginous and capsular procedures. Marked variability exists in the post-operative weight-bearing practices of hip arthroscopy surgeons. This study suggests that most surgeons allow immediate weight bearing as tolerated after labral resection, acetabular osteoplasty, chondroplasty and psoas tenotomy. For cartilage defect procedures, 6 weeks or more non-weight bearing is suggested depending on the area of the defect and lateral central edge angle. Delayed return to sports activities is suggested after microfracture procedures. The level of evidence was Level V expert opinions.

Hip arthroscopy protocol: expert opinions on post-operative weight bearing and return to sports guidelines

PubMed Central

Rath, Ehud; Paret, Matan; Amar, Eyal; Drexler, Michael; Bonin, Nicolas

2017-01-01

Abstract The objectives of this study are to survey the weight-bearing limitation practices and delay for returning to running and impact sports of high volume hip arthroscopy orthopedic surgeons. The study was designed in the form of expert survey questionnaire. Evidence-based data are scares regarding hip arthroscopy post-operative weight-bearing protocols. An international cross-sectional anonymous Internet survey of 26 high-volume hip arthroscopy specialized surgeons was conducted to report their weight-bearing limitations and rehabilitation protocols after various arthroscopic hip procedures. The International Society of Hip Arthroscopy invited this study. The results were examined in the context of supporting literature to inform the studies suggestions. Four surgeons always allow immediate weight bearing and five never offer immediate weight bearing. Seventeen surgeons provide weight bearing depending on the procedures performed: 17 surgeons allowed immediate weight bearing after labral resection, 10 after labral repair and 8 after labral reconstruction. Sixteen surgeons allow immediate weight bearing after psoas tenotomy. Twenty-one respondents restrict weight bearing after microfracture procedures for 3–8 weeks post-operatively. Return to running and impact sports were shorter for labral procedures and bony procedures and longer for cartilaginous and capsular procedures. Marked variability exists in the post-operative weight-bearing practices of hip arthroscopy surgeons. This study suggests that most surgeons allow immediate weight bearing as tolerated after labral resection, acetabular osteoplasty, chondroplasty and psoas tenotomy. For cartilage defect procedures, 6 weeks or more non-weight bearing is suggested depending on the area of the defect and lateral central edge angle. Delayed return to sports activities is suggested after microfracture procedures. The level of evidence was Level V expert opinions. PMID:28630722

Dependency of image quality on acquisition protocol and image processing in chest tomosynthesis-a visual grading study based on clinical data.

PubMed

Jadidi, Masoud; Båth, Magnus; Nyrén, Sven

2018-04-09

To compare the quality of images obtained with two different protocols with different acquisition time and the influence from image post processing in a chest digital tomosynthesis (DTS) system. 20 patients with suspected lung cancer were imaged with a chest X-ray equipment with tomosynthesis option. Two examination protocols with different acquisition times (6.3 and 12 s) were performed on each patient. Both protocols were presented with two different image post-processing (standard DTS processing and more advanced processing optimised for chest radiography). Thus, 4 series from each patient, altogether 80 series, were presented anonymously and in a random order. Five observers rated the quality of the reconstructed section images according to predefined quality criteria in three different classes. Visual grading characteristics (VGC) was used to analyse the data and the area under the VGC curve (AUC VGC ) was used as figure-of-merit. The 12 s protocol and the standard DTS processing were used as references in the analyses. The protocol with 6.3 s acquisition time had a statistically significant advantage over the vendor-recommended protocol with 12 s acquisition time for the classes of criteria, Demarcation (AUC VGC = 0.56, p = 0.009) and Disturbance (AUC VGC = 0.58, p < 0.001). A similar value of AUC VGC was found also for the class Structure (definition of bone structures in the spine) (0.56) but it could not be statistically separated from 0.5 (p = 0.21). For the image processing, the VGC analysis showed a small but statistically significant advantage for the standard DTS processing over the more advanced processing for the classes of criteria Demarcation (AUC VGC = 0.45, p = 0.017) and Disturbance (AUC VGC = 0.43, p = 0.005). A similar value of AUC VGC was found also for the class Structure (0.46), but it could not be statistically separated from 0.5 (p = 0.31). The study indicates that the protocol with 6.3 s acquisition time yields slightly better image quality than the vender-recommended protocol with acquisition time 12 s for several anatomical structures. Furthermore, the standard gradation processing  (the vendor-recommended post-processing for DTS), yields to some extent advantage over the gradation processing/multiobjective frequency processing/flexible noise control processing in terms of image quality for all classes of criteria. Advances in knowledge: The study proves that the image quality may be strongly affected by the selection of DTS protocol and that the vendor-recommended protocol may not always be the optimal choice.

Optimization of Delayed Tolerance Induction in Swine: A Clinically-Relevant Protocol for Immunosuppression-Free Vascularized Composite Allotransplantation

DTIC Science & Technology

2017-10-01

information if it does not display a currently valid OMB control number. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS. 1. REPORT DATE October...been achieved in nonhuman primates (NHPs) using a the delayed period protocol, i.e combination of post- transplant non -myeloablative conditioning and...seminars, study groups , and individual study. Include participation in conferences, workshops, and seminars not listed under major activities

Viral Oncolytic Therapeutics for Neoplastic Meningitis

DTIC Science & Technology

2012-07-01

will in due course approach DOD for approval of the animal protocol. 15. SUBJECT TERMS Viral oncolysis, neoplastic meningitis , cell lines, HSV-1...proposed study is to develop novel, safe and efficient therapy for neoplastic meningitis – that of HSV-1 oncolysis. The viral genome is genetically...1 AD_________________ Award Number: W81XWH-11-1-0388 TITLE: Viral Oncolytic Therapeutics for Neoplastic

Finding orthopedic patients lost to follow-up for long-term outcomes research using the Internet: an update for 2012.

PubMed

Louie, Dexter L; Earp, Brandon E; Blazar, Philip E

2012-07-01

The Internet is available to researchers as a tool for studying long-term outcomes, but no recent research exists on how to best use it. The authors hypothesize that using the Internet can be at least 75% effective in locating patients lost to follow-up. With Institutional Review Board approval, the authors searched for 66 patients lost to follow-up after a period of 10 years or more with no contact. They tested an Internet searching protocol developed in 2004 and developed an alternate protocol. In all, 74% (49/66) of patients were located. Copyright 2012, SLACK Incorporated.

Compliance with nutrition support guidelines in acutely burned patients.

PubMed

Holt, Brennen; Graves, Caran; Faraklas, Iris; Cochran, Amalia

2012-08-01

Adequate and timely provision of nutritional support is a crucial component of care of the critically ill burn patient. The goal of this study was to assess a single center's consistency with Society of Critical Care Medicine/American Society for Parenteral and Enteral Nutrition (SCCM/ASPEN) guidelines for nutritional support in critically ill patients. Acutely burned patients >45kg in weight admitted to a regional burn center during a two-year period and who required 5 or more days of full enteral nutritional support were eligible for inclusion in this retrospective review. Specific outcomes evaluated include time from admission to feeding tube placement and enteral feeding initiation and percent of nutritional goal received within the first week of hospital stay. Descriptive statistics were used for all analyses. IRB approval was obtained. Thirty-seven patients were included in this retrospective review. Median age of patients was 44.9 years (IQR: 24.2-55.1), and median burn injury size was 30% (IQR: 19-47). Median time to feeding tube placement was 31.1h post admission (IQR: 23.6-50.2h), while median time to initiation of EN was 47.9h post admission (IQR: 32.4-59.9h). The median time required for patients to reach 60% of caloric goal was 3 days post-admission (IQR: 3-4.5). The median time for initiation of enteral nutrition was within the SCCM/ASPEN guidelines for initial nutrition in the critically ill patient. This project identified a 16h time lag between placement of enteral access and initiation of enteral nutrition. Development of a protocol for feeding tube placement and enteral nutrition management may optimize early nutritional support in the acutely injured burn patient. Copyright © 2012 Elsevier Ltd and ISBI. All rights reserved.

Costs and inconsistencies in US IRB review of low-risk medical education research.

PubMed

Kano, Miria; Getrich, Christina M; Romney, Crystal; Sussman, Andrew L; Williams, Robert L

2015-06-01

Advances in communication technologies over the last two decades have transformed the way medical education research is conducted, creating opportunities for multi-institution national and international studies. Although these studies enable researchers to gain broader understandings of educational processes across institutions, they increase the need for multiple institutional review board (IRB) reviews to ensure the protection of human subjects. This study describes the process of obtaining multiple IRB approvals of the same protocol for a multi-site, low-risk, medical education research project in the USA. The burden of obtaining those reviews and their consistency are assessed. The associated time and costs, and implications for the research process are detailed. Following review by the investigators' parent institution IRB, the project team circulated a uniform protocol for conduct of a low-risk, medical education survey to the IRBs of 89 US medical schools for review. The processes and time required to obtain approvals were recorded to estimate associated research team personnel costs. Approval could not be obtained from five IRBs as a result of insurmountable procedural barriers. A total of 67 IRBs eventually deferred to the parent IRB determination. The remaining IRBs required a variety of additional procedural processes before ultimately agreeing with the original determination. The personnel costs associated with obtaining the 84 approvals amounted to US$121,344. Considering the value of multi-site designs to address a range of research questions, enhance participant diversity and develop representative findings, solutions must be found to counter inefficiencies of current IRB review processes for low-risk research, such as that usually conducted in medical education. Although we acknowledge that local review is an essential protective measure for research involving identifiable communities that are uniquely susceptible to social or economic harm, this report suggests that proposals to modernise and streamline IRB review processes for low-risk research are timely and relevant. © 2015 John Wiley & Sons Ltd.

Regional citrate anticoagulation in hemodialysis: an observational study of safety, efficacy, and effect on calcium balance during routine care.

PubMed

Singer, Richard F; Williams, Oliver; Mercado, Chari; Chen, Bonny; Talaulikar, Girish; Walters, Giles; Roberts, Darren M

2016-01-01

Regional citrate hemodialysis anticoagulation is used when heparin is contraindicated, but most protocols require large infusions of calcium and frequent intradialytic plasma ionized calcium measurements. The objective of this study was to determine the safety, efficacy, and effect on calcium balance of regional citrate anticoagulation using sparse plasma ionized calcium sampling. The design of this study was observational. The setting of this study was the hospital hemodialysis center. The subjects of this study were the hospital hemodialysis patients. Dialysate calcium concentration by atomic absorption spectroscopy and total dialysate weight were used as measurements. Regional citrate anticoagulation was introduced using zero calcium dialysate, pre-dialyzer citrate infusion, and post-dialyzer calcium infusion. Infusions were adjusted based on pre- and post-dialyzer calcium measurements obtained at least twice during a 4-h dialysis. The protocol was simplified after the first 357 sessions to dispense with post-dialyzer calcium measurements. Heparin-anticoagulated sessions were performed using acetate-acidified 1.25 mmol/L calcium or citrate-acidified 1.5 mmol/L calcium dialysate. Calcium balance assessment was by complete dialysate recovery. Safety and efficacy were assessed prospectively using a point-of-care database to record ionized calcium and clinical events. Groups were compared using t test, ANOVA, Wilcoxon rank sum, or Kruskal-Wallis as appropriate. Seventy-five patients received regional citrate-anticoagulated dialysis over 1051 dialysis sessions. Of these, 357 dialysis sessions were performed using the original citrate anticoagulation protocol and 694 using the simplified protocol. Dialysis was effective and safe. Only 3 dialyzers clotted; 1 patient suffered symptomatic hypercalcemia and none suffered symptomatic hypocalcemia. Calcium balance was assessed in 15 regional citrate-anticoagulated dialysis sessions and 30 heparin-anticoagulated sessions. The median calcium loss was 0.8 mmol/h dialyzed in both groups (p = 0.43), and end of treatment ionized calcium was the same in both groups (1.07 ± 0.04 mmol/L). Our findings for calcium balance, efficacy, and safety are valid only for the protocol studied, which excluded patient with severe liver dysfunction. Regional citrate dialysis can be performed safely and effectively using a sparse plasma calcium sampling protocol. The calcium balance induced by this protocol is not different to that seen in standard heparin-anticoagulated dialysis, but in the absence of prospective studies, it is unknown whether this is optimal for patient care.

Hair sparing does not compromise real-time magnetic resonance imaging guided stereotactic laser fiber placement for temporal lobe epilepsy.

PubMed

Singh, Shikha; Kumar, Kevin K; Rabon, Matthew J; Dolce, Dana; Halpern, Casey H

2018-06-01

Pre-operative scalp shaving is conventionally thought to simplify postoperative cranial wound care, lower the rate of wound infections, and ease optimal incision localization. Over the past few decades, some neurosurgeons have refrained from scalp shaving in order to improve patient satisfaction with brain surgery. However, this hair-sparing approach has not yet been explored in the growing field of magnetic resonance-guided laser interstitial thermal therapy (MRgLITT). This study investigated the initial impact of a no-shave technique on post-operative wound infection rate as well as on entry and target accuracy in MRgLITT for mesial temporal epilepsy. Eighteen patients selected by the Stanford Comprehensive Epilepsy Program between November 2015 and August 2017 were included in the study. All patients underwent functional selective amygdalohippocampotomies using MRgLITT entirely within a diagnostic MRI suite. No hair was removed and no additional precautions were taken for hair or scalp care. Otherwise, routine protocols for surgical preparations and wound closure were followed. The study was performed under approval from Stanford University's Internal Review Board (IRB-37830). No post-operative wound infections or erosions occurred for any patient. The mean entry point error was 2.87 ± 1.3 mm and the mean target error was 1.0 ± 0.9 mm. There have been no other complications associated with this hair-sparing approach. The study's results suggest that hair sparing in MRgLITT surgery for temporal epilepsy does not increase the risk of wound complications or compromise accuracy. This preferred cosmetic approach may thus appeal to epilepsy patients considering such interventions. Copyright © 2018 Elsevier Ltd. All rights reserved.

Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial

PubMed Central

2013-01-01

Background Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery. Methods A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. Discussion The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). Trial registration ClinicalTrials.gov (http://NCT01558765). PMID:23782510

Evaluation of Effectiveness of Embolization in Pelvic Congestion Syndrome with the New Vascular Occlusion Device (ArtVentive EOS™): Preliminary Results

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pyra, Krzysztof, E-mail: k.pyra@poczta.fm; Woźniak, Sławomir, E-mail: slavwo7572@gmail.com; Drelich-Zbroja, Anna, E-mail: zbroanna@interia.pl

PurposeThis study aimed to collect confirmatory data in support of the safety and efficiency of the ArtVentive EOS™ for the treatment of the pelvic congestion syndrome (PCS). This study was based on the OCCLUDE 1 Study Protocol approved by the Local Ethics Committee.Materials and MethodsA prospective study carried out in June and July 2014 included 12 women aged 21–48 years (mean 31 years) scheduled for PCS embolization using the ArtVentive EOS™. The inclusion criteria were clinical symptoms of PCS documented by transvaginal Doppler ultrasound and pelvic MRI. The pelvic pain was assessed by VAS score from 0 to 10 (0 represents lackmore » of pain and 10 unbearable pain). A decrease in pelvic pain intensity based on the VAS was considered a clinical success.ResultsSuccessful embolization procedures with ArtVentive EOS™ were performed in 11 out of 12 patients. Nine patients underwent unilateral embolization of the left ovarian vein, and two had bilateral embolization of the ovarian veins. Complete ovarian vein occlusion confirmed by post deployment venography was achieved in all 11 patients. Procedures lasted from 19 to 45 min (average 28 min). Pain intensity decrease was observed in all 11 patients—a decrease of 5.6 points—from 7.3 pre-procedure to 1.6 post-embolization (standard deviation: 0.67). In one case, the left ovarian vein was injured by guide wire manipulation with contrast extravasation—not clinically significant.ConclusionsThe use of ArtVentive EOS™ for occlusion of the ovarian veins in PCS patients is safe and effective.« less

Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial.

PubMed

Sibilitz, Kirstine Laerum; Berg, Selina Kikkenborg; Hansen, Tina Birgitte; Risom, Signe Stelling; Rasmussen, Trine Bernholdt; Hassager, Christian; Køber, Lars; Steinbrüchel, Daniel; Gluud, Christian; Winkel, Per; Thygesen, Lau Caspar; Hansen, Jane Lindschou; Schmid, Jean Paul; Conraads, Viviane; Brocki, Barbara Christina; Zwisler, Ann-Dorthe

2013-04-22

Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery. A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). ClinicalTrials.gov (http://NCT01558765).

Capacity for ethical and regulatory review of herbal trials in developing countries: a case study of Moringa oleifera research in HIV-infected patients.

PubMed

Monera-Penduka, Tsitsi G; Maponga, Charles C; Morse, Gene D; Nhachi, Charles F B

2017-01-01

Lack of regulatory capacity limits the conduct of ethical and rigorous trials of herbal medicines in developing countries. Sharing ethical and regulatory experiences of successful herbal trials may accelerate the field while assuring human subjects protection. The methods and timelines for the ethical and regulatory review processes for the first drug regulatory authority approved herbal trial in Zimbabwe are described in this report. The national drug regulatory authority and ethics committee were engaged for pre-submission discussions. Six applications were submitted. Application procedures and communications with the various regulatory and ethics review boards were reviewed. Key issues raised and timelines for communications were summarized. There was no special framework for the approval of herbal trials. One local institutional review committee granted an exemption. Key issues raised for revision were around pre-clinical efficacy and safety data, standardization and quality assurance of the intervention as well as consenting procedures. Approval timelines ranged between eight and 72 weeks. In the absence of a defined framework for review of herbal trials, approval processes can be delayed. Dialogue between researchers and regulators is important for successful and efficient protocol approval for herbal trials in developing countries. The study was registered prospectively on August 3, 2011 with clinicaltrials.gov (NCT01410058).

39 CFR 111.4 - Approval of the Director of the Federal Register.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 39 Postal Service 1 2010-07-01 2010-07-01 false Approval of the Director of the Federal Register. 111.4 Section 111.4 Postal Service UNITED STATES POSTAL SERVICE POST OFFICE SERVICES [DOMESTIC MAIL] GENERAL INFORMATION ON POSTAL SERVICE § 111.4 Approval of the Director of the Federal Register...

42 CFR 37.4 - Plans for chest roentgenographic examinations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... covered by the plan; (4) The name and location of the approved X-ray facility or facilities, and the... approval as the originally approved plan. (e) The operator must promptly display in a visible location on... NIOSH. The proposed plan or change in plan must remain posted in a visible location on the bulletin...

$627 Million Gulf Spill Restoration Plan Approved | NOAA Gulf Spill

Science.gov Websites

Publications Press Releases Story Archive Home $627 Million Gulf Spill Restoration Plan Approved $627 Million Gulf Spill Restoration Plan Approved Bird landing on water share Posted on October 3, 2014 | Assessment Gulf of Mexico early restoration projects since the oil spill. The restoration plan includes 44

Japanese Physicians' Views on Drug Post-Marketing Surveillance.

PubMed

Maeda, Kazuki; Katashima, Rumi; Ishizawa, Keisuke; Yanagawa, Hiroaki

2015-12-01

Registration trials leading to the approval of drugs are paramount in drug development. After approval, continuous efforts are necessary to ensure proper use of the approved drugs. In Japan, post-marketing surveillance (PMS) by drug companies is conducted in accordance with good post-marketing study practice (GPSP). Although the global standard for pharmacovigilance is incorporated into GPSP, attention has recently been focused on disassociating them. In this study, we examined physicians' views on PMS with the aim of conducting PMS more effectively. We retrospectively reviewed records between 2009 and 2013 from the institutional review board of Tokushima University Hospital, an academic hospital in rural Japan. The annual number of times PMS was performed was then determined. Next, we assessed physicians' attitudes toward drug PMS, including ethical issues, in a cross-sectional study using a questionnaire designed for this study. Five- and two-point scales were used. The questionnaire was distributed in 2014 to 221 physicians listed as investigators in PMS contracts. Of the 221 physicians, 103 (46.6%) responded to the questionnaire. About 50% of the respondents had experience writing PMS reports. Many of the physicians considered PMS to be important but burdensome. Furthermore, from the viewpoint of research ethics, many physicians considered it improper within the present PMS framework to collect and provide data beyond the scope of routine clinical practice without obtaining informed consent in the case of extra blood sampling, provision of images, monitoring and controlled studies. Beyond practical factors such as workload, attention should be given to establishing an ethical infrastructure and globally harmonized system with regard to the Japanese PMS system. Given the limitations of this single-institution study, further research is needed to collect information for developing a suitable infrastructure.

Optimal early active mobilisation protocol after extensor tendon repairs in zones V and VI: A systematic review of literature.

PubMed

Collocott, Shirley Jf; Kelly, Edel; Ellis, Richard F

2018-03-01

Early mobilisation protocols after repair of extensor tendons in zone V and VI provide better outcomes than immobilisation protocols. This systematic review investigated different early active mobilisation protocols used after extensor tendon repair in zone V and VI. The purpose was to determine whether any one early active mobilisation protocol provides superior results. An extensive literature search was conducted to identify articles investigating the outcomes of early active mobilisation protocols after extensor tendon repair in zone V and VI. Databases searched were AMED, Embase, Medline, Cochrane and CINAHL. Studies were included if they involved participants with extensor tendon repairs in zone V and VI in digits 2-5 and described a post-operative rehabilitation protocol which allowed early active metacarpophalangeal joint extension. Study designs included were randomised controlled trials, observational studies, cohort studies and case series. The Structured Effectiveness Quality Evaluation Scale was used to evaluate the methodological quality of the included studies. Twelve articles met the inclusion criteria. Two types of early active mobilisation protocols were identified: controlled active motion protocols and relative motion extension splinting protocols. Articles describing relative motion extension splinting protocols were more recent but of lower methodological quality than those describing controlled active motion protocols. Participants treated with controlled active motion and relative motion extension splinting protocols had similar range of motion outcomes, but those in relative motion extension splinting groups returned to work earlier. The evidence reviewed suggested that relative motion extension splinting protocols may allow an earlier return to function than controlled active motion protocols without a greater risk of complication.

48 CFR 22.404-10 - Posting wage determinations and notice.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Posting wage... Contracts Involving Construction 22.404-10 Posting wage determinations and notice. The contractor must keep a copy of the applicable wage determination (and any approved additional classifications) posted at...

FDA Approves Apalutamide for Prostate Cancer

Cancer.gov

Apalutamide (Erleada) is a hormone therapy that counteracts resistance to androgen deprivation therapy. Learn more about the FDA approval of apalutamide for men with castration-resistant nonmetastatic prostate cancer in this Cancer Currents blog post.

One-year results of the use of endovenous radiofrequency ablation utilising an optimised radiofrequency-induced thermotherapy protocol for the treatment of truncal superficial venous reflux.

PubMed

Badham, George E; Dos Santos, Scott J; Lloyd, Lucinda Ba; Holdstock, Judy M; Whiteley, Mark S

2018-06-01

Background In previous in vitro and ex vivo studies, we have shown increased thermal spread can be achieved with radiofrequency-induced thermotherapy when using a low power and slower, discontinuous pullback. We aimed to determine the clinical success rate of radiofrequency-induced thermotherapy using this optimised protocol for the treatment of superficial venous reflux in truncal veins. Methods Sixty-three patients were treated with radiofrequency-induced thermotherapy using the optimised protocol and were followed up after one year (mean 16.3 months). Thirty-five patients returned for audit, giving a response rate of 56%. Duplex ultrasonography was employed to check for truncal reflux and compared to initial scans. Results In the 35 patients studied, there were 48 legs, with 64 truncal veins treated by radiofrequency-induced thermotherapy (34 great saphenous, 15 small saphenous and 15 anterior accessory saphenous veins). One year post-treatment, complete closure of all previously refluxing truncal veins was demonstrated on ultrasound, giving a success rate of 100%. Conclusions Using a previously reported optimised, low power/slow pullback radiofrequency-induced thermotherapy protocol, we have shown it is possible to achieve a 100% ablation at one year. This compares favourably with results reported at one year post-procedure using the high power/fast pullback protocols that are currently recommended for this device.

Normative Feedback for Parents of College Students: Piloting a Parent Based Intervention to Correct Misperceptions of Students’ Alcohol Use and Other Parents’ Approval of Drinking

PubMed Central

LaBrie, Joseph W.; Napper, Lucy E.; Hummer, Justin F.

2013-01-01

Objective Multi-component parent-based interventions (PBIs) provide a promising avenue for targeting alcohol use and related consequences in college students. Parents of college-aged children can have a significant influence on their children’s alcohol use decisions. However, parents tend to underestimate their own child’s alcohol use and overestimate other similar parents’ approval of student drinking. These misperceptions could have important implications for parents’ own attitudes and alcohol-related communication with their student. Targeting these misperceptions through normative feedback could help promote greater and more in-depth alcohol-related communication. The present study examines the potential efficacy of web-based alcohol-related normative feedback for parents of college students. Method A sample of 144 parents of college students received web-based normative feedback about students’ alcohol use and approval, as well as other same-college parents’ alcohol approval. Parents completed measures of perceived student alcohol use, student alcohol approval, other-parent alcohol approval, and intentions to discuss alcohol use both pre- and post-normative feedback. Results Post-feedback, parents reported stronger intentions to talk to their student about alcohol, were less confident in their knowledge of their students’ alcohol use, and believed that their student drank in greater quantity and more frequently than pre-feedback. Parents also perceived other parents to be less approving of alcohol use after viewing normative feedback. Conclusions These findings provide preliminary support for the use of web-based normative feedback for parents of college students. Given these promising results, further research developing and testing this approach merits attention. PMID:24099892

Implementation of Symptom Protocols for Nurses Providing Telephone‐Based Cancer Symptom Management: A Comparative Case Study

PubMed Central

Green, Esther; Ballantyne, Barbara; Tarasuk, Joy; Skrutkowski, Myriam; Carley, Meg; Chapman, Kim; Kuziemsky, Craig; Kolari, Erin; Sabo, Brenda; Saucier, Andréanne; Shaw, Tara; Tardif, Lucie; Truant, Tracy; Cummings, Greta G.; Howell, Doris

2016-01-01

ABSTRACT Background The pan‐Canadian Oncology Symptom Triage and Remote Support (COSTaRS) team developed 13 evidence‐informed protocols for symptom management. Aim To build an effective and sustainable approach for implementing the COSTaRS protocols for nurses providing telephone‐based symptom support to cancer patients. Methods A comparative case study was guided by the Knowledge to Action Framework. Three cases were created for three Canadian oncology programs that have nurses providing telephone support. Teams of researchers and knowledge users: (a) assessed barriers and facilitators influencing protocol use, (b) adapted protocols for local use, (c) intervened to address barriers, (d) monitored use, and (e) assessed barriers and facilitators influencing sustained use. Analysis was within and across cases. Results At baseline, >85% nurses rated protocols positively but barriers were identified (64‐80% needed training). Patients and families identified similar barriers and thought protocols would enhance consistency among nurses teaching self‐management. Twenty‐two COSTaRS workshops reached 85% to 97% of targeted nurses (N = 119). Nurses felt more confident with symptom management and using the COSTaRS protocols (p < .01). Protocol adaptations addressed barriers (e.g., health records approval, creating pocket versions, distributing with telephone messages). Chart audits revealed that protocols used were documented for 11% to 47% of patient calls. Sustained use requires organizational alignment and ongoing leadership support. Linking Evidence to Action Protocol uptake was similar to trials that have evaluated tailored interventions to improve professional practice by overcoming identified barriers. Collaborating with knowledge users facilitated interpretation of findings, aided protocol adaptation, and supported implementation. Protocol implementation in nursing requires a tailored approach. A multifaceted intervention approach increased nurses’ use of evidence‐informed protocols during telephone calls with patients about symptoms. Training and other interventions improved nurses’ confidence with using COSTaRS protocols and their uptake was evident in some documented telephone calls. Protocols could be adapted for use by patients and nurses globally. PMID:27243574

Implementation of an Emergency Department Sepsis Bundle and System Redesign: A Process Improvement Initiative.

PubMed

McColl, Tamara; Gatien, Mathieu; Calder, Lisa; Yadav, Krishan; Tam, Ryan; Ong, Melody; Taljaard, Monica; Stiell, Ian

2017-03-01

In 2008-2009, the Canadian Institute for Health Information reported over 30,000 cases of sepsis hospitalizations in Canada, an increase of almost 4,000 from 2005. Mortality rates from severe sepsis and septic shock continue to remain greater than 30% in Canada and are significantly higher than other critical conditions treated in the emergency department (ED). Our group formed a multidisciplinary sepsis committee, conducted an ED process of care analysis, and developed a quality improvement protocol. The objective of this study was to evaluate the effects of this sepsis management bundle on patient mortality. This before and after study was conducted in two large Canadian tertiary care EDs and included adult patients with suspected severe infection that met at least two systemic inflammatory response syndrome (SIRS) criteria. We studied the implementation of a sepsis bundle including triage flagging, RN medical directive, education campaign, and a modified sepsis protocol. The primary outcomes were 30-day all-cause mortality and sepsis protocol use. We included a total of 167 and 185 patients in the pre- and post-intervention analysis, respectively. Compared to the pre-intervention group, mortality was significantly lower in the post-intervention group (30.7% versus 17.3%; absolute difference, 13.4%; 95% CI 9.8-17.0; p=0.006). There was also a higher rate of sepsis protocol use in the post-intervention group (20.3% versus 80.5%, absolute difference 60.2%; 95% CI 55.1-65.3; p<0.001). Additionally, we found shorter time-intervals from triage to MD assessment, fluid resuscitation, and antibiotic administration as well as lower rates of vasopressor requirements and ICU admission. Interpretation The implementation of our multidisciplinary ED sepsis bundle, including improved early identification and protocolized medical care, was associated with improved time to achieve key therapeutic interventions and a reduction in 30-day mortality. Similar low-cost initiatives could be implemented in other EDs to potentially improve outcomes for this high-risk group of patients.

Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan.

PubMed

Mori, Jinichi; Tanimoto, Tetsuya; Miura, Yuji; Kami, Masahiro

2015-06-01

All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry. We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action. Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance. All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Acute effects of static and dynamic stretching on jump performance after 15 min of reconditioning shooting phase in basketball players.

PubMed

Annino, Giuseppe; Ruscello, Bruno; Lebone, Pietro; Palazzo, Francesco; Lombardo, Mauro; Padua, Elvira; Verdecchia, Luca; Tancredi, Virginia; Iellamo, Ferdinando

2017-04-01

The aim of this study was to assess the effects of static (SS) and dynamic stretching (DS) on vertical jump performance executed before, immediately after and at the end of the shooting phase (i.e., 15 min later), as to simulate the actual conditions preceding a match, in professional basketball players. Ten elite basketball players (age: 29±6.73 years, height: 194.67±7.75 cm, weight: 91±8.17 kg and BMI 23.8±7.91 kg.m-2) participated to the study. SS and DS protocols were administered during the first training session of the week, 48 hours after the championship match. Stretching protocols consisted in ~7 minutes of general warm-up phase followed by ~8 minutes of SS and DS, performed with a cross-over design., and ~15 minutes of a specific warm-up shooting phase (SP). Vertical jump tests consisted in counter movement jump (CMJ) and CMJ with arm swings (CMJas) and were performed immediately after the end of each stretching phase (preS, postS, postSP). A significant decrease (P=0.05; η2partial=0.29) in jumping tests height occurred in CMJas, when performed after the SS (i.e., PostS). However, no significant differences in jumping performances, occurred after the general warm phase and the specific warm-up shooting phase, between the two stretching protocols. These results would indicate that, overall, stretching routines either dynamic or static, performed before a basketball match are transient and affect only marginally leg muscles performance. Stretching routines, particularly the dynamic ones, may be useful to maintain muscle performance before a competition, provided that this latter begins shortly after.

Ethics review of studies during public health emergencies - the experience of the WHO ethics review committee during the Ebola virus disease epidemic.

PubMed

Alirol, Emilie; Kuesel, Annette C; Guraiib, Maria Magdalena; de la Fuente-Núñez, Vânia; Saxena, Abha; Gomes, Melba F

2017-06-26

Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee (WHO-ERC) was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies including interventional (drug, vaccine) and observational studies. WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues (benefit-risk assessment, study design, exclusion of pregnant women and children from interventional studies, data and sample sharing, collaborative partnerships including international and local researchers and communities, community engagement and participant information) are presented. To accelerate study approval in future public health emergencies, we recommend: (1) internally consistent and complete submissions with information documents in language participants are likely to understand, (2) close collaboration between local and international researchers from research inception, (3) generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, (4) formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, (5) formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to strengthen reviews through the different perspectives provided without the 'opportunity costs' for time to final approval of multiple, independent reviews, (6) direct information exchange between the chairs of advisory, safety review and ethics committees, (7) more Ethics Committee support for investigators than is standard and (8) a global consultation on criteria for inclusion of pregnant women and children in interventional studies for conditions which put them at particularly high risk of mortality or other irreversible adverse outcomes under standard-of-care.

A Hybrid Analysis for Security Protocols with State

DTIC Science & Technology

2014-07-16

Approved for Public Release; Distribution Unlimited. 14-1013. A Hybrid Analysis for Security Protocols with State∗ John D. Ramsdell Daniel J ...their consequences in the anno - tated protocol theory Tannot(Π, ) use only the limited vocabulary of Tbnd(Π); we call them bridge lemmas. Lemma 3 is a...and we proved it using pvs. Lemma 1 (Prefix Boot Extend). ∀π ∈ path, t :>, i, k ∈ N. i ≤ k ∧ π(k) has t ⊃ subterm(π(i), π(k)) ∨ ∃ j ∈ N. i ≤ j < k ∧ π

PCoD Lite - Using an Interim PCoD Protocol to Assess the Effects of Disturbance Associated with US Navy Exercises on Marine Mammal Populations

DTIC Science & Technology

2015-09-30

1 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. PCoD Lite - Using an Interim PCoD Protocol to Assess...US National Research Council (NRC 2005). Here, we provide an insight into how the Interim PCoD approach (Harwood et al. 2014, King et al. 2015...illustrate how the interim PCoD protocol can be used to inform the process of determining whether or not Navy activities are likely to have an impact on

PCoD Lite - Using an Interim PCoD Protocol to Assess the Effects of Disturbance Associated with US Navy Exercises on Marine Mammal Populations

DTIC Science & Technology

2014-09-30

1 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. PCoD Lite - Using an Interim PCoD Protocol to Assess...Skookum Tom Road Friday Harbor, WA, USA phone: 1-360-370-5493 email: jw@smrullc.com Award Number: N000141410406 http://www.smrumarine.com/ pcod ...DATE 30 SEP 2014 2. REPORT TYPE 3. DATES COVERED 00-00-2014 to 00-00-2014 4. TITLE AND SUBTITLE PCoD Lite - Using an Interim PCoD Protocol to

Emulation of Industrial Control Field Device Protocols

DTIC Science & Technology

2013-03-01

platforms such as the Arduino ( based on the Atmel AVR architecture) or popular PIC architecture based devices, which are programmed for specific functions...UNIVERSITY AIR FORCE INSTITUTE OF TECHNOLOGY Wright-Patterson Air Force Base , Ohio DISTRIBUTION STATEMENT A. APPROVED FOR PUBLIC RELEASE; DISTRIBUTION...confidence intervals for the mean. Based on these results, extensive knowledge of the specific implementations of the protocols or timing profiles of the

Development and Validation of a Porcine (Sus scrofa) Sepsis Model

DTIC Science & Technology

2018-03-01

last IACUC approval, have any methods been identified to reduce the number of live animals used in this protocol? None 10. PUBLICATIONS...SUMMARY: (Please provide, in "ABSTRACT" format, a summary of the protocol objectives, materials and methods , results - include tables/figures, and...Materials and methods : Animals were anesthetized and instrumented for cardiovascular monitoring. Lipopolysaccharide (LPS, a large molecule present on the

Opioid Abuse after Traumatic Brain Injury: Evaluation Using Rodent Models

DTIC Science & Technology

2013-07-01

acclimation to the laboratory and handling, catheterization surgery and recovery, brain injury and evaluation of acquisition, reinforcing efficacy or...subjects entered into protocol =112 (10+10+20+22+ 24+26) Total number catheterized =62 Total number undergoing sham injury =33...did not enter into the experimental protocol until after VCU IACUC and ACURO approval in July 2013. Twenty-two subjects have been catheterized and

Research and Operational Support for the Study of Militarily Relevant Infectious Diseases of Interest to United States and Royal Thai Governments

DTIC Science & Technology

2004-01-01

resistance of exo-erythrocytic stage parasites to primaquine and tafenoquine ). B.2. Parasite Characterization: In the absence of an in vitro culture...Tropical Diseases, Mahidol University. Efforts are partnered with Pfizer and the NIH. Developed and approved a protocol to test tafenoquine (WR238605) in...completed by September 2004. Publication of previous dose-ranging studies of tafenoquine completed. Publication of prophylaxis study in the Royal

Observational Study to Assess the Therapeutic Value of Four Ovarian Hyperstimulation Protocols in IVF After Pituitary Suppression with GnRH Antagonists in Normally Responding Women.

PubMed

Ana, Monzó; Vicente, Montañana; María, Rubio José; Trinidad, García-Gimeno; Alberto, Romeu

2011-02-22

To compare the clinical results of four different protocols of COH for IVF-ICSI in normovulatory women, using in all cases pituitary suppression with GnRH antagonists. A single center, open label, parallel-controlled, prospective, post-authorization study under the approved conditions for use where 305 normal responders women who were candidates to COH were assigned to r-FSH +hp-hMG (n = 51, Group I), hp-hMG (n = 61, Group II), fixed-dose r-FSH (n = 118, Group III), and r-FSH with potential dose adjustment (n = 75, Group IV) to subsequently undergo IVF-ICSI. During stimulation, Group IV needed significantly more days of stimulation as compared to Group II [8.09 ± 1.25 vs. 7.62 ± 1.17; P < 0.05], but was the group in which more oocytes were recovered [Group I: 9.43 ± 4.99 vs. Group II: 8.96 ± 4.82 vs. Group III: 8.78 ± 3.72 vs. Group IV: 11.62 ± 5.80; P < 0.05]. No significant differences were seen between the groups in terms of clinical and ongoing pregnancy, but among patients in whom two embryos with similar quality parameters (ASEBIR) were transferred, the group treated with hp-hMG alone achieved a significantly greater clinical pregnancy rate as compared to all other groups [Group I: 31.6%, Group II: 56.4%, Group III: 28.7%, Group IV: 32.7%; P < 0.05]. Although randomized clinical trials should be conducted to achieve a more reliable conclusion, these observations support the concept that stimulation with hp-hMG could be beneficial in normal responders women undergoing pituitary suppression with GnRH antagonists.

Mechanism evaluation of a lifestyle intervention for patients with musculoskeletal pain who are overweight or obese: protocol for a causal mediation analysis

PubMed Central

Lee, Hopin; Wiggers, John; Kamper, Steven J; Williams, Amanda; O'Brien, Kate M; Hodder, Rebecca K; Yoong, Sze Lin; Campbell, Elizabeth; Haskins, Robin; Robson, Emma K; McAuley, James H; Williams, Christopher M

2017-01-01

Introduction Low back pain (LBP) and knee osteoarthritis (OA) are highly prevalent and disabling conditions that cause societal and economic impact worldwide. Two randomised controlled trials (RCTs) will evaluate the effectiveness of a multicomponent lifestyle intervention for patients with LBP and knee OA who are overweight or obese. The key targets of this intervention are to improve physical activity, modify diet and correct pain beliefs. These factors may explain how a lifestyle intervention exerts its effects on key patient-relevant outcomes: pain, disability and quality of life. The aim of this protocol is to describe a planned analysis of a mechanism evaluation for a lifestyle intervention for overweight or obese patients with LBP and knee OA. Methods and analysis Causal mediation analyses of 2 two-armed RCTs. Both trials are part of a cohort-multiple RCT, embedded in routine health service delivery. In each respective trial, 160 patients with LBP and 120 patients with knee OA waiting for orthopaedic consultation will be randomised to a lifestyle intervention, or to remain part of the original cohort. The intervention consists of education and advice about the benefits of weight loss and physical activity, and the Australian New South Wales Get Healthy Service. All outcome measures including patient characteristics, primary and alternative mediators, outcomes, and potential confounders will be measured at baseline (T0). The primary mediator, weight, will be measured at 6 months post randomisation; alternative mediators including diet, physical activity and pain beliefs will be measured at 6 weeks post randomisation. All outcomes (pain, disability and quality of life) will be measured at 6 months post randomisation. Data will be analysed using causal mediation analysis with sensitivity analyses for sequential ignorability. All mediation models were specified a priori before completing data collection and without prior knowledge about the effectiveness of the intervention. Ethics and dissemination The study is approved by the Hunter New England Health Human Research Ethics Committee (13/12/11/5.18) and the University of Newcastle Human Research Ethics Committee (H-2015–0043). The results will be disseminated in peer-reviewed journals and at scientific conferences. Trial registration number ACTRN12615000490572 and ACTRN12615000478516; Pre-results. PMID:28674135

Mechanism evaluation of a lifestyle intervention for patients with musculoskeletal pain who are overweight or obese: protocol for a causal mediation analysis.

PubMed

Lee, Hopin; Wiggers, John; Kamper, Steven J; Williams, Amanda; O'Brien, Kate M; Hodder, Rebecca K; Wolfenden, Luke; Yoong, Sze Lin; Campbell, Elizabeth; Haskins, Robin; Robson, Emma K; McAuley, James H; Williams, Christopher M

2017-07-03

Low back pain (LBP) and knee osteoarthritis (OA) are highly prevalent and disabling conditions that cause societal and economic impact worldwide. Two randomised controlled trials (RCTs) will evaluate the effectiveness of a multicomponent lifestyle intervention for patients with LBP and knee OA who are overweight or obese. The key targets of this intervention are to improve physical activity, modify diet and correct pain beliefs. These factors may explain how a lifestyle intervention exerts its effects on key patient-relevant outcomes: pain, disability and quality of life. The aim of this protocol is to describe a planned analysis of a mechanism evaluation for a lifestyle intervention for overweight or obese patients with LBP and knee OA. Causal mediation analyses of 2 two-armed RCTs. Both trials are part of a cohort-multiple RCT, embedded in routine health service delivery. In each respective trial, 160 patients with LBP and 120 patients with knee OA waiting for orthopaedic consultation will be randomised to a lifestyle intervention, or to remain part of the original cohort. The intervention consists of education and advice about the benefits of weight loss and physical activity, and the Australian New South Wales Get Healthy Service. All outcome measures including patient characteristics, primary and alternative mediators, outcomes, and potential confounders will be measured at baseline (T0). The primary mediator, weight, will be measured at 6 months post randomisation; alternative mediators including diet, physical activity and pain beliefs will be measured at 6 weeks post randomisation. All outcomes (pain, disability and quality of life) will be measured at 6 months post randomisation. Data will be analysed using causal mediation analysis with sensitivity analyses for sequential ignorability. All mediation models were specified a priori before completing data collection and without prior knowledge about the effectiveness of the intervention. The study is approved by the Hunter New England Health Human Research Ethics Committee (13/12/11/5.18) and the University of Newcastle Human Research Ethics Committee (H-2015-0043). The results will be disseminated in peer-reviewed journals and at scientific conferences. ACTRN12615000490572 and ACTRN12615000478516; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

High-intensity interval exercise training before abdominal aortic aneurysm repair (HIT-AAA): protocol for a randomised controlled feasibility trial.

PubMed

Tew, Garry A; Weston, Matthew; Kothmann, Elke; Batterham, Alan M; Gray, Joanne; Kerr, Karen; Martin, Denis; Nawaz, Shah; Yates, David; Danjoux, Gerard

2014-01-10

In patients with large abdominal aortic aneurysm (AAA), open surgical or endovascular aneurysm repair procedures are often used to minimise the risk of aneurysm-related rupture and death; however, aneurysm repair itself carries a high risk. Low cardiopulmonary fitness is associated with an increased risk of early post-operative complications and death following elective AAA repair. Therefore, fitness should be enhanced before aneurysm repair. High-intensity interval exercise training (HIT) is a potent, time-efficient strategy for enhancing cardiopulmonary fitness. Here, we describe a feasibility study for a definitive trial of a pre-operative HIT intervention to improve post-operative outcomes in patients undergoing elective AAA repair. A minimum of 50 patients awaiting elective repair of a 5.5-7.0 cm infrarenal AAA will be allocated by minimisation to HIT or usual care control in a 1:1 ratio. The patients allocated to HIT will complete three hospital-based exercise sessions per week, for 4 weeks. Each session will include 2 or 4 min of high-intensity stationary cycling followed by the same duration of easy cycling or passive recovery, repeated until a total of 16 min of high-intensity exercise is accumulated. Outcomes to be assessed before randomisation and 24-48 h before aneurysm repair include cardiopulmonary fitness, maximum AAA diameter and health-related quality of life. In the post-operative period, we will record destination (ward or critical care unit), organ-specific morbidity, mortality and the durations of critical care and hospital stay. Twelve weeks after the discharge, participants will be interviewed to reassess quality of life and determine post-discharge healthcare utilisation. The costs associated with the exercise intervention and healthcare utilisation will be calculated. Ethics approval was secured through Sunderland Research Ethics Committee. The findings of the trial will be disseminated through peer-reviewed journals, and national and international presentations. Current Controlled Trials ISRCTN09433624.

Rationally optimized cryopreservation of multiple mouse embryonic stem cell lines: II—Mathematical prediction and experimental validation of optimal cryopreservation protocols☆

PubMed Central

Kashuba, Corinna M.; Benson, James D.; Critser, John K.

2014-01-01

In Part I, we documented differences in cryopreservation success measured by membrane integrity in four mouse embryonic stem cell (mESC) lines from different genetic backgrounds (BALB/c, CBA, FVB, and 129R1), and we demonstrated a potential biophysical basis for these differences through a comparative study characterizing the membrane permeability characteristics and osmotic tolerance limits of each cell line. Here we use these values to predict optimal cryoprotectants, cooling rates, warming rates, and plunge temperatures. We subsequently verified these predictions experimentally for their effects on post-thaw recovery. From this study, we determined that a cryopreservation protocol utilizing 1 M propylene glycol, a cooling rate of 1 °C/minute, and plunging into liquid nitrogen at −41 °C, combined with subsequent warming in a 22 °C water bath with agitation, significantly improved post-thaw recovery for three of the four mESC lines, and did not diminish post-thaw recovery for our single exception. It is proposed that this protocol can be successfully applied to most mESC lines beyond those included within this study once the effect of propylene glycol on mESC gene expression, growth characteristics, and germ-line transmission has been determined. Mouse ESC lines with poor survival using current standard cryopreservation protocols or our proposed protocol can be optimized on a case-by-case basis using the method we have outlined over two papers. For our single exception, the CBA cell line, a cooling rate of 5 °C/minute in the presence of 1.0 M dimethyl sulfoxide or 1.0 M propylene glycol, combined with plunge temperature of −80 °C was optimal. PMID:24560712

FUNCTIONAL OUTCOMES OF HIP ARTHROSCOPY IN AN ACTIVE DUTY MILITARY POPULATION UTILIZING A CRITERION-BASED EARLY WEIGHT BEARING PROGRESSION

PubMed Central

Jacobs, Jeremy M.; Evanson, J. Richard; Pniewski, Josh; Dickston, Michelle L.; Mueller, Terry; Bojescul, John A.

2017-01-01

Introduction Hip arthroscopy allows surgeons to address intra-articular pathology of the hip while avoiding more invasive open surgical dislocation. However the post-operative rehabilitation protocols have varied greatly in the literature, with many having prolonged periods of limited motion and weight bearing. Purpose The purpose of this study was to describe a criterion-based early weight bearing protocol following hip arthroscopy and investigate functional outcomes in the subjects who were active duty military. Methods Active duty personnel undergoing hip arthroscopy for symptomatic femoroacetabular impingement were prospectively assessed in a controlled environment for the ability to incorporate early postoperative weight-bearing with the following criteria: no increased pain complaint with weight bearing and normalized gait pattern. Modified Harris Hip (HHS) and Hip Outcome score (HOS) were performed preoperatively and at six months post-op. Participants were progressed with a standard hip arthroscopy protocol. Hip flexion was limited to not exceed 90 degrees for the first three weeks post-op, with progression back to running beginning at three months. Final discharge was dependent upon the ability to run two miles at military specified pace and do a single leg broad jump within six inches of the contralateral leg without an increase in pain. Results Eleven participants met inclusion criteria over the study period. Crutch use was discontinued at an average of five days following surgery based on established weight bearing criteria. Only one participant required continued crutch use at 15 days. Participants’ functional outcome was improved postoperatively, as demonstrated by significant increases in HOS and HHS. At the six month follow up, eight of 11 participants were able to take and complete a full Army Physical Fitness Test. Conclusions Following completion of the early weight bearing rehabilitation protocol, 81% of participants were able to progress to full weight bearing by four days post-operative, with normalized pain-free gait patterns. Active duty personnel utilizing an early weight bearing protocol following hip arthroscopy demonstrated significant functional improvement at six months. Level of Evidence Level 4, Case-series PMID:29181261

FUNCTIONAL OUTCOMES OF HIP ARTHROSCOPY IN AN ACTIVE DUTY MILITARY POPULATION UTILIZING A CRITERION-BASED EARLY WEIGHT BEARING PROGRESSION.

PubMed

Shaw, K Aaron; Jacobs, Jeremy M; Evanson, J Richard; Pniewski, Josh; Dickston, Michelle L; Mueller, Terry; Bojescul, John A

2017-10-01

Hip arthroscopy allows surgeons to address intra-articular pathology of the hip while avoiding more invasive open surgical dislocation. However the post-operative rehabilitation protocols have varied greatly in the literature, with many having prolonged periods of limited motion and weight bearing. The purpose of this study was to describe a criterion-based early weight bearing protocol following hip arthroscopy and investigate functional outcomes in the subjects who were active duty military. Active duty personnel undergoing hip arthroscopy for symptomatic femoroacetabular impingement were prospectively assessed in a controlled environment for the ability to incorporate early postoperative weight-bearing with the following criteria: no increased pain complaint with weight bearing and normalized gait pattern. Modified Harris Hip (HHS) and Hip Outcome score (HOS) were performed preoperatively and at six months post-op. Participants were progressed with a standard hip arthroscopy protocol. Hip flexion was limited to not exceed 90 degrees for the first three weeks post-op, with progression back to running beginning at three months. Final discharge was dependent upon the ability to run two miles at military specified pace and do a single leg broad jump within six inches of the contralateral leg without an increase in pain. Eleven participants met inclusion criteria over the study period. Crutch use was discontinued at an average of five days following surgery based on established weight bearing criteria. Only one participant required continued crutch use at 15 days. Participants' functional outcome was improved postoperatively, as demonstrated by significant increases in HOS and HHS. At the six month follow up, eight of 11 participants were able to take and complete a full Army Physical Fitness Test. Following completion of the early weight bearing rehabilitation protocol, 81% of participants were able to progress to full weight bearing by four days post-operative, with normalized pain-free gait patterns. Active duty personnel utilizing an early weight bearing protocol following hip arthroscopy demonstrated significant functional improvement at six months. Level 4, Case-series.

Short-term effect of local muscle vibration treatment versus sham therapy on upper limb in chronic post-stroke patients: a randomized controlled trial.

PubMed

Costantino, Cosimo; Galuppo, Laura; Romiti, Davide

2017-02-01

In recent years, local muscle vibration received considerable attention as a useful method for muscle stimulation in clinical therapy. Some studies described specific vibration training protocol, and few of them were conducted on post-stroke patients. Therefore there is a general uncertainty regarding the vibrations protocol. The aim of this study was to evaluate the effects of local muscle high frequency mechano-acoustic vibratory treatment on grip muscle strength, muscle tonus, disability and pain in post-stroke individuals with upper limb spasticity. Single-blind randomized controlled trial. Outpatient rehabilitation center. Thirty-two chronic poststroke patients with upper-limb spasticity: 21 males, 11 females, mean age 61.59 years ±15.50, time passed from stroke 37.78±17.72 months. The protocol treatment consisted of the application of local muscle vibration, set to a frequency of 300 Hz, for 30 minutes 3 times per week, for 12 sessions, applied to the skin covering the venter of triceps brachii and extensor carpi radialis longus and brevis muscles during voluntary isometric contraction. All participants were randomized in two groups: group A treated with vibration protocol; group B with sham therapy. All participants were evaluated before and after 4-week treatment with Hand Grip Strength Test, Modified Ashworth Scale, QuickDASH score, FIM scale, Fugl-Meyer Assessment, Jebsen-Taylor Hand Function Test and Verbal Numerical Rating Scale of pain. Outcomes between groups was compared using a repeated-measures ANOVA. Over 4 weeks, the values recorded in group A when compared to group B demonstrated statistically significant improvement in grip muscle strength, pain and quality of life and decrease of spasticity; P-values were <0.05 in all tested parameters. Rehabilitation treatment with local muscle high frequency (300 Hz) vibration for 30 minutes, 3 times a week for 4 weeks, could significantly improve muscle strength and decrease muscle tonus, disability and pain in upper limb of hemiplegic post-stroke patients. Local muscle vibration treatment might be an additional and safe tool in the management of chronic poststroke patients, granted its high therapeutic efficiency, limited cost and short and repeatable protocol of use.

The effect of various cold-water immersion protocols on exercise-induced inflammatory response and functional recovery from high-intensity sprint exercise.

PubMed

White, Gillian E; Rhind, Shawn G; Wells, Greg D

2014-11-01

The purpose of this study was to investigate the effects of different cold-water immersion (CWI) protocols on the inflammatory response to and functional recovery from high-intensity exercise. Eight healthy recreationally active males completed five trials of a high-intensity intermittent sprint protocol followed by a randomly assigned recovery condition: 1 of 4 CWI protocols (CWI-10 min × 20 °C, CWI-30 min × 20 °C, CWI-10 min × 10 °C, or CWI-30 min × 10 °C) versus passive rest. Circulating mediators of the inflammatory response were measured from EDTA plasma taken pre-exercise (baseline), immediately post-exercise, and at 2, 24, and 48 h post-exercise. Ratings of perceived soreness and impairment were noted on a 10-pt Likert scale, and squat jump and drop jump were performed at these time points. IL-6, IL-8, and MPO increased significantly from baseline immediately post-exercise in all conditions. IL-6 remained elevated from baseline at 2 h in the CWI-30 min × 20 °C, CWI-10 min × 10 °C, and CWI-30 min × 10 °C conditions, while further increases were observed for IL-8 and MPO in the CWI-30 min × 20 °C and CWI-30 min × 10 °C conditions. Squat jump and drop jump height were significantly lower in all conditions immediately post-exercise and at 2 h. Drop jump remained below baseline at 24 and 48 h in the CON and CWI-10 min × 20 °C conditions only, while squat jump height returned to baseline in all conditions. Cold-water immersion appears to facilitate restoration of muscle performance in a stretch-shortening cycle, but not concentric power. These changes do not appear to be related to inflammatory modulation. CWI protocols of excessive duration may actually exacerbate the concentration of cytokines in circulation post-exercise; however, the origin of the circulating cytokines is not necessarily skeletal muscle.

DoD Alcohol and Substance Abuse Consortium Award

DTIC Science & Technology

2016-10-01

opiate use disorder (OUD) also has developed significant clinical importance due to prolonged pain treatments with opiates. FDA approved...2) behaviors other than amount of alcohol consumed will be examined, such as anxiety-like behavior, sensitivity to pain and avoidance of an...The prospectus will be reviewed by the entire SRPP Committee and a subset of applications will be approved to develop a 10- to 20-page mini -protocol

Biometric Identification Verification Technology Status and Feasibility Study

DTIC Science & Technology

1994-09-01

L’., .- CONTRACT No. DNA 001 -93-C-01 37 Approved for public release;T distribution Is unlimited. ~v 94g’ Destroy this report when it is no longer...DISTRIBUI ION/AVAILABILITY STATEMENT 12b. DISTRIBUTION CODE Approved for public release; distribution is unlimited. 13. ABSTRACT (Maximurm 200 wvrds) DoD...guys." 4lie issue is then reduced to one of positive identification and control. Traditiozal~y, this has beeýu accomplished by posting a guard or entry

Midwest Guardrail System (MGS) with southern yellow pine posts.

DOT National Transportation Integrated Search

2013-09-01

The Midwest Guardrail System (MGS) has previously been approved for use with various alternative species of wood posts. However, Southern Yellow Pine (SYP) is the most common wood guardrail post material in the United States. The goal of this researc...

IL-6, Antioxidant Capacity and Muscle Damage Markers Following High-Intensity Interval Training Protocols.

PubMed

Cipryan, Lukas

2017-02-01

The aim of this study was to investigate changes of interleukin-6 (IL-6), total antioxidant capacity (TAC) and muscle damage markers (creatine kinase (CK), myoglobin and lactate dehydrogenase (LDH)) in response to three different high-intensity interval training (HIIT) protocols of identical external work. Twelve moderately-trained males participated in the three HIIT trials which consisted of a warm-up, followed by 12 min of 15 s, 30 s or 60 s HIIT sequences with the work/rest ratio 1. The biochemical markers of inflammation, oxidative stress and muscle damage were analysed POST, 3 h and 24 h after the exercise. All HIIT protocols caused an immediate increase in IL-6, TAC, CK, myoglobin and LDH. The most pronounced between-trials differences were found for the POST-exercise changes in IL-6 (Effect size ± 90% confidence interval: 1.51 ± 0.63, 0.84 ± 0.34 and 1.80 ± 0.60 for the 15s/15s, 30s/30s and 60s/60s protocol, respectively) and myoglobin (1.11 ± 0.29, 0.45 ± 0.48 and 1.09 ± 0.22 for the 15s/15s, 30s/30s and 60s/60s protocol, respectively). There were no substantial between-trial differences in other biochemical variables. In conclusion, the 15s/15s and 60s/60s protocols might be preferred to the 30s/30s protocols in order to maximize the training stimulus.

Branched Nerve Allografts to Improve Outcomes in Facial Composite Tissue Transplantation

DTIC Science & Technology

2017-12-01

Ethicon, Inc. Somervile, N.J.). Postoperatively, animals were recovered per standard protocol in the animal care facility.  Experimental Design ...official Department of the Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved OMB No...a human xenograft with or without oral Tacrolimus. Electrophysiologic assessments were performed pre -operatively and at the study endpoint (24 weeks

Standardization and validation of real time PCR assays for the diagnosis of histoplasmosis using three molecular targets in an animal model

PubMed Central

López, Luisa F.; Muñoz, César O.; Cáceres, Diego H.; Tobón, Ángela M.; Loparev, Vladimir; Clay, Oliver; Chiller, Tom; Litvintseva, Anastasia; Gade, Lalitha; González, Ángel

2017-01-01

Histoplasmosis is considered one of the most important endemic and systemic mycoses worldwide. Until now few molecular techniques have been developed for its diagnosis. The aim of this study was to develop and evaluate three real time PCR (qPCR) protocols for different protein-coding genes (100-kDa, H and M antigens) using an animal model. Fresh and formalin-fixed and paraffin-embedded (FFPE) lung tissues from BALB/c mice inoculated i.n. with 2.5x106 Histoplasma capsulatum yeast or PBS were obtained at 1, 2, 3, 4, 8, 12 and 16 weeks post-infection. A collection of DNA from cultures representing different clades of H. capsulatum (30 strains) and other medically relevant pathogens (36 strains of related fungi and Mycobacterium tuberculosis) were used to analyze sensitivity and specificity. Analytical sensitivity and specificity were 100% when DNAs from the different strains were tested. The highest fungal burden occurred at first week post-infection and complete fungal clearance was observed after the third week; similar results were obtained when the presence of H. capsulatum yeast cells was demonstrated in histopathological analysis. In the first week post-infection, all fresh and FFPE lung tissues from H. capsulatum-infected animals were positive for the qPCR protocols tested except for the M antigen protocol, which gave variable results when fresh lung tissue samples were analyzed. In the second week, all qPCR protocols showed variable results for both fresh and FFPE tissues. Samples from the infected mice at the remaining times post-infection and uninfected mice (controls) were negative for all protocols. Good agreement was observed between CFUs, histopathological analysis and qPCR results for the 100-kDa and H antigen protocols. We successfully standardized and validated three qPCR assays for detecting H. capsulatum DNA in fresh and FFPE tissues, and conclude that the 100-kDa and H antigen molecular assays are promising tests for diagnosing this mycosis. PMID:29287097

Development of risk reduction behavioral counseling for Ebola virus disease survivors enrolled in the Sierra Leone Ebola Virus Persistence Study, 2015-2016.

PubMed

Abad, Neetu; Malik, Tasneem; Ariyarajah, Archchun; Ongpin, Patricia; Hogben, Matthew; McDonald, Suzanna L R; Marrinan, Jaclyn; Massaquoi, Thomas; Thorson, Anna; Ervin, Elizabeth; Bernstein, Kyle; Ross, Christine; Liu, William J; Kroeger, Karen; Durski, Kara N; Broutet, Nathalie; Knust, Barbara; Deen, Gibrilla F

2017-09-01

During the 2014-2016 West Africa Ebola Virus Disease (EVD) epidemic, the public health community had concerns that sexual transmission of the Ebola virus (EBOV) from EVD survivors was a risk, due to EBOV persistence in body fluids of EVD survivors, particularly semen. The Sierra Leone Ebola Virus Persistence Study was initiated to investigate this risk by assessing EBOV persistence in numerous body fluids of EVD survivors and providing risk reduction counseling based on test results for semen, vaginal fluid, menstrual blood, urine, rectal fluid, sweat, tears, saliva, and breast milk. This publication describes implementation of the counseling protocol and the key lessons learned. The Ebola Virus Persistence Risk Reduction Behavioral Counseling Protocol was developed from a framework used to prevent transmission of HIV and other sexually transmitted infections. The framework helped to identify barriers to risk reduction and facilitated the development of a personalized risk-reduction plan, particularly around condom use and abstinence. Pre-test and post-test counseling sessions included risk reduction guidance, and post-test counseling was based on the participants' individual test results. The behavioral counseling protocol enabled study staff to translate the study's body fluid test results into individualized information for study participants. The Ebola Virus Persistence Risk Reduction Behavioral Counseling Protocol provided guidance to mitigate the risk of EBOV transmission from EVD survivors. It has since been shared with and adapted by other EVD survivor body fluid testing programs and studies in Ebola-affected countries.

Dynamic Postural Control in Female Athletes and Nonathletes After a Whole-Body Fatigue Protocol.

PubMed

Baghbani, Fatemeh; Woodhouse, Linda J; Gaeini, Abbas A

2016-07-01

Baghbani, F, Woodhouse, LJ, and Gaeini, AA. Dynamic postural control in female athletes and nonathletes after a whole-body fatigue protocol. J Strength Cond Res 30(7): 1942-1947, 2016-Postural control is a crucial element in regular training of athletes, development of complex technical movement, and injury prevention; however, distributing factor of the postural control such as fatigue has been neglected by athletic trainers in novice and inexperienced athletes. The objective of this study was to compare changes in dynamic postural control of young female athletes and nonathletes after a fatigue protocol. Thirty females (15 athletes and 15 nonathletes) with no orthopedic problems were recruited to participate in this study. All participants completed the pre-SEBT (star excursion balance test) in 8 directions at baseline; then, they performed a 20-minute fatigue protocol after which post-SEBT was measured. Rating of perceived exertion was measured using the Borg scale immediately before, mid-way through (i.e., after the third station), and after performing the fatigue protocol (i.e., immediately before the post-SEBT). Female nonathlete groups had significant differences in dynamic balance performance after fatigue in the medial, posteromedial, and posterior directions (p < 0.01) measured by SEBT. Athletes, however, showed no significant changes after the fatigue protocol. Our results indicates the importance of evaluation and monitoring of dynamic postural control of the novice with progressing the exercise time. Our findings could also help coaches to develop trainings focused on the 3 directions of medial, posteromedial, and posterior directions and aimed at exercises increasing fatigue resistance.

A comparison of single and multiple stressor protocols to assess acute stress in a coastal shark species, Rhizoprionodon terraenovae.

PubMed

Hoffmayer, Eric R; Hendon, Jill M; Parsons, Glenn R; Driggers, William B; Campbell, Matthew D

2015-10-01

Elasmobranch stress responses are traditionally measured in the field by either singly or serially sampling an animal after a physiologically stressful event. Although capture and handling techniques are effective at inducing a stress response, differences in protocols could affect the degree of stress experienced by an individual, making meaningful comparisons between the protocols difficult, if not impossible. This study acutely stressed Atlantic sharpnose sharks, Rhizoprionodon terraenovae, by standardized capture (rod and reel) and handling methods and implemented either a single or serial blood sampling protocol to monitor four indicators of the secondary stress response. Single-sampled sharks were hooked and allowed to swim around the boat until retrieved for a blood sample at either 0, 15, 30, 45, or 60 min post-hooking. Serially sampled sharks were retrieved, phlebotomized, released while still hooked, and subsequently resampled at 15, 30, 45, and 60 min intervals post-hooking. Blood was analyzed for hematocrit, and plasma glucose, lactate, and osmolality levels. Although both single and serial sampling protocols resulted in an increase in glucose, no significant difference in glucose level was found between protocols. Serially sampled sharks exhibited cumulatively heightened levels for lactate and osmolality at all time intervals when compared to single-sampled animals at the same time. Maximal concentration differences of 217.5, 9.8, and 41.6 % were reported for lactate, osmolality, and glucose levels, respectively. Hematocrit increased significantly over time for the single sampling protocol but did not change significantly during the serial sampling protocol. The differences in resultant blood chemistry levels between implemented stress protocols and durations are significant and need to be considered when assessing stress in elasmobranchs.

Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

PubMed

Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; 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; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

2014-07-16

To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

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

PubMed

Husebø, Sissel Eikeland; Olsen, Øystein Evjen

2016-08-10

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

Alterations of the amplitude of low-frequency fluctuation in healthy subjects with theta-burst stimulation of the cortex of the suprahyoid muscles.

PubMed

Ruan, Xiuhang; Xu, Guangqing; Gao, Cuihua; Liu, Lingling; Liu, Yanli; Jiang, Lisheng; Chen, Xin; Yu, Shaode; Jiang, Xinqing; Lan, Yue; Wei, Xinhua

2017-12-04

Theta burst stimulation (TBS) has emerged as a promising tool for the treatment of swallowing disorders; however, the short-term after-effects of brain activation induced by TBS remain unknown. Here, we measured the changes in spontaneous brain activation using the amplitude of low-frequency fluctuation (ALFF) approach in subjects who underwent different TBS protocols. Sixty right-handed healthy participants (male, n=30; female, n=30; mean age=23.5y) were recruited in this study and randomly assigned to three groups that underwent three different TBS protocols. In group 1, continuous TBS (cTBS) was positioned on the left hemisphere of the suprahyoid muscle cortex. For group 2, intermittent TBS (iTBS) was placed on the left hemisphere of the suprahyoid muscle cortex. Group 3 underwent combined cTBS/iTBS protocols in which iTBS on the right hemisphere was performed immediately after completing cTBS on the left suprahyoid muscle cortex. Compared to pre-TBS, post-cTBS showed decreased ALFF in the anterior cingulate gyrus (BA 32); post-iTBS induced an increase in ALFF in the bilateral precuneus (BA 7); and post-cTBS/iTBS induced a decrease in ALFF in the brainstem, and resulted in increased ALFF in the middle cingulate gyrus (BA 24) as well as the left precentral gyrus (BA 6). Compared the effect of post-TBS protocols, increased ALFF was found in left posterior cerebellum lobe and left inferior parietal lobule (BA 40) (post-cTBS vs post-iTBS), and decreased ALFF exhibited in paracentral lobule (BA 4) (post-iTBS vs post-cTBS/iTBS). These findings indicate that multiple brain areas involved in swallowing regulation after stimulation of TBS over the suprahyoid muscles. cTBS induces decreased after-effects while iTBS results in increased after-effects on spontaneous brain activation. Moreover, iTBS can eliminate the after-effects of cTBS applied on the contralateral swallowing cortex and alter the activity of contralateral motor cortex and brainstem. Our findings provide a novel evidence for the short-term effect of TBS on spontaneous brain activation. Copyright © 2017 IBRO. Published by Elsevier Ltd. All rights reserved.

Dose reduction in whole-body computed tomography of multiple injuries (DoReMI): protocol for a prospective cohort study

PubMed Central

2014-01-01

Background Single-pass, contrast-enhanced whole body multidetector computed tomography (MDCT) emerged as the diagnostic standard for evaluating patients with major trauma. Modern iterative image algorithms showed high image quality at a much lower radiation dose in the non-trauma setting. This study aims at investigating whether the radiation dose can safely be reduced in trauma patients without compromising the diagnostic accuracy and image quality. Methods/Design Prospective observational study with two consecutive cohorts of patients. Setting: A high-volume, academic, supra-regional trauma centre in Germany. Study population: Consecutive male and female patients who 1. had been exposed to a high-velocity trauma mechanism, 2. present with clinical evidence or high suspicion of multiple trauma (predicted Injury Severity Score [ISS] ≥16) and 3. are scheduled for primary MDCT based on the decision of the trauma leader on call. Imaging protocols: In a before/after design, a consecutive series of 500 patients will undergo single-pass, whole-body 128-row multi-detector computed tomography (MDCT) with a standard, as low as possible radiation dose. This will be followed by a consecutive series of 500 patients undergoing an approved ultra-low dose MDCT protocol using an image processing algorithm. Data: Routine administrative data and electronic patient records, as well as digital images stored in a picture archiving and communications system will serve as the primary data source. The protocol was approved by the institutional review board. Main outcomes: (1) incidence of delayed diagnoses, (2) diagnostic accuracy, as correlated to the reference standard of a synopsis of all subsequent clinical, imaging, surgical and autopsy findings, (3) patients’ safety, (4) radiation exposure (e.g. effective dose), (5) subjective image quality (assessed independently radiologists and trauma surgeons on a 100-mm visual analogue scale), (6) objective image quality (e.g., contrast-to-noise ratio). Analysis: Multivariate regression will be employed to adjust and correct the findings for time and cohort effects. An exploratory interim analysis halfway after introduction of low-dose MDCT will be conducted to assess whether this protocol is clearly inferior or superior to the current standard. Discussion Although non-experimental, this study will generate first large-scale data on the utility of imaging-enhancing algorithms in whole-body MDCT for major blunt trauma. Trial registration Current Controlled Trials ISRCTN74557102. PMID:24589310

World Hip Trauma Evaluation (WHiTE): framework for embedded comprehensive cohort studies.

PubMed

Costa, Matthew L; Griffin, Xavier L; Achten, Juul; Metcalfe, David; Judge, Andrew; Pinedo-Villanueva, Rafael; Parsons, Nicholas

2016-10-21

Osteoporotic hip fractures present a significant global challenge to patients, clinicians and healthcare systems. It is estimated that hip fracture accounts for 1.4% of total social and healthcare costs in the established market economies. The World Hip Trauma Evaluation (WHiTE) was set up to measure outcome in a comprehensive cohort of UK patients with hip fracture. All patients in the cohort are treated under a single comprehensive treatment pathway. A core outcome set, including health-related quality of life, is collected on all the patients. This protocol describes the current multicentre project that will be used as a vehicle to deliver a series of embedded observational studies. Research Ethics Committee approval was granted (Rec reference 11/LO/0927, approved 18/8/2011) and each hospital trust provided National Health Service (NHS) approvals. The study is registered with National Institute of Health Research Portfolio (UKCRN ID 12351) and the ISRCTN registry (ISRCTN63982700). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Does a resistance exercise session with continuous or intermittent blood flow restriction promote muscle damage and increase oxidative stress?

PubMed

Neto, Gabriel R; Novaes, Jefferson S; Salerno, Verônica P; Gonçalves, Michel M; Batista, Gilmário R; Cirilo-Sousa, Maria S

2018-01-01

The aim of this study was to compare the effect of low-load resistance exercise (LLRE) with continuous and intermittent blood flow restriction (BFR) on the creatine kinase (CK), lactate dehydrogenase (LDH), protein carbonyl (PC), thiobarbituric acid-reactive substance (TBARS) and uric acid (UA) levels in military men. The study included 10 recreationally trained men aged 19 ± 0.82 years who underwent the following experimental protocols in random order on separate days (72-96 h): 4 LLRE sessions at a 20% 1RM (one-repetition maximum [1RM]) with continuous BFR (LLRE + CBFR); 4 LLRE sessions at 20% 1RM with intermittent BFR (LLRE + IBFR) and 4 high-intensity resistance exercise (HIRE) sessions at 80% 1RM. The CK and LDH (markers of muscle damage) levels were measured before exercise (BE), 24 h post-exercise and 48 h post-exercise, and the PC, TBARS and UA (markers of oxidative stress) levels were measured BE and immediately after each exercise session. There was a significant increase in CK in the HIRE 24 post-exercise samples compared with the LLRE + CBFR and LLRE + IBFR (P = 0.035, P = 0.036, respectively), as well as between HIRE 48 post-exercise and LLRE + CBFR (P = 0.049). Additionally, there was a significant increase in CK in the LLRE + CBFR samples BE and immediately after each exercise (Δ = 21.9%) and in the HIRE samples BE and immediately after each exercise, BE and 24 post-exercise, and BE and 48 post-exercise (Δ values of 35%, 177.6%, and 177.6%, respectively). However, there were no significant changes in LDH, PC, TBARS, and UA between the protocols (P > 0.05). Therefore, a physical exercise session with continuous or intermittent BFR did not promote muscle damage; moreover, neither protocol seemed to affect the oxidative stress markers.

Early full weight-bearing versus 6-week partial weight-bearing after open wedge high tibial osteotomy leads to earlier improvement of the clinical results: a prospective, randomised evaluation.

PubMed

Schröter, S; Ateschrang, A; Löwe, W; Nakayama, H; Stöckle, U; Ihle, C

2017-01-01

Open wedge high tibial osteotomy is a widespread treatment option in patients with varus malalignment and medial compartment osteoarthritis. There is no standardised protocol for post-operative rehabilitation available. The purpose of this study was to compare two post-operative rehabilitation protocols and to evaluate the clinical outcome of early full weight-bearing after open wedge HTO. One hundred and twenty consecutive patients with varus malalignment and medial compartment osteoarthritis received an open wedge HTO using an angular locking plate fixation between December 2008 and December 2011. All patients were assigned randomly into one of two groups with different post-operative rehabilitation protocols (11-day vs. 6-week 20-kg partial weight-bearing). Clinical outcome was evaluated using established instruments (Lequesne, Lysholm, HSS and IKDC scores) preoperatively, 6, 12 and 18 months post-operatively. Deformity analysis was performed preoperatively and during follow-up. All clinical scores showed a significant pre- to post-operative improvement. After 6 months, there was a higher improvement in the group of early full weight-bearing. The difference between preoperative and 6-month follow-up for the group with early full weight-bearing and for the group with 20-kg PWB for 6 weeks was 28 ± 26 and 18 ± 22, respectively, for the Lysholm score and -5.0 ± 5.1 and -3.0 ± 3.6, respectively, for the Lequesne score. Early full weight-bearing (11-day 20-kg partial weight-bearing) after open wedge HTO without bone graft leads to earlier improvement of the clinical results and can be recommended for post-operative rehabilitation after open wedge HTO and fixation with an angular locking plate. Therapeutic study, Level I.

14 CFR 1264.135 - Post-hearing briefs.

Code of Federal Regulations, 2010 CFR

2010-01-01

... FRAUD CIVIL PENALTIES ACT OF 1986 § 1264.135 Post-hearing briefs. The presiding officer may require the parties to file post-hearing briefs. In any event, upon approval of the presiding officer, any party may... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Post-hearing briefs. 1264.135 Section 1264...

14 CFR 1264.135 - Post-hearing briefs.

Code of Federal Regulations, 2013 CFR

2013-01-01

... FRAUD CIVIL PENALTIES ACT OF 1986 § 1264.135 Post-hearing briefs. The presiding officer may require the parties to file post-hearing briefs. In any event, upon approval of the presiding officer, any party may... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Post-hearing briefs. 1264.135 Section 1264...

14 CFR 1264.135 - Post-hearing briefs.

Code of Federal Regulations, 2012 CFR

2012-01-01

... FRAUD CIVIL PENALTIES ACT OF 1986 § 1264.135 Post-hearing briefs. The presiding officer may require the parties to file post-hearing briefs. In any event, upon approval of the presiding officer, any party may... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Post-hearing briefs. 1264.135 Section 1264...

14 CFR 1264.135 - Post-hearing briefs.

Code of Federal Regulations, 2011 CFR

2011-01-01

... FRAUD CIVIL PENALTIES ACT OF 1986 § 1264.135 Post-hearing briefs. The presiding officer may require the parties to file post-hearing briefs. In any event, upon approval of the presiding officer, any party may... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Post-hearing briefs. 1264.135 Section 1264...

Ovarian dynamics in response to two modified intravaginal progesterone releasing device and oestradiol benzoate based ovulation synchronisation protocols designed for use in Brahman heifers.

PubMed

Edwards, S A A; Atkinson, P C; Satake, N; Boe-Hansen, G; McGowan, M R

2014-07-01

The objective was to investigate the ovarian response of Brahman heifers to two modified ovulation synchronisation protocols developed to increase the proportion of normal synchronous ovulations. Experiment 1 characterised the growth of the ovulatory follicle in heifers (n=19) treated with an intravaginal progesterone releasing device (IPRD) and oestradiol benzoate (ODB), to determine the optimal time to induce ovulation. Using the findings from Experiment 1, Experiment 2 investigated the effect of reducing the duration of IPRD insertion and increasing the interval from IPRD removal to ODB treatment (modified protocol 1 - OPO-6; n=20), and omitting ODB treatment at the time of IPRD insertion (modified protocol 2 - PO-6; n=20). An IPRD (0.78 g progesterone) was inserted at Day 0 (OPO-8) or Day 2 (OPO-6 and PO-6) and all heifers also received 1 mg ODB i.m. Day 8: IPRD removed + 500 μg cloprostenol i.m. At 24 h (OPO-8) and 36 h (OPO-6 and PO-6) post IPRD removal: 1 mg ODB i.m. Fixed-time AI (FTAI) occurred at 54 h for OPO-8 and 72 h for OPO-6 and PO-6, post IPRD removal. After IPRD treatment all OPO-6 and OPO-8 heifers initiated a new follicular wave whereas 25% of PO-6 heifers failed. Diameter of the dominant follicle was larger at FTAI in the PO-6 (11.34 ± 0.50 mm) compared to the OPO-8 protocol (9.74 ± 0.51 mm; P<0.05), but similar to the OPO-6 protocol (10.52 ± 0.51 mm). Proportion of ovulations occurring 12 h prior and 24 h post FTAI was similar for the PO-6 (80%) and OPO-6 (75%) protocols but numerically lower in the OPO-8 heifers (60%). The apparent improvement in ovarian response in heifers treated with the modified protocols needs to be confirmed in larger field studies. Copyright © 2014 Elsevier B.V. All rights reserved.

A Communication Protocol for CyAMS and the Cyber Fighter Associate Interface

DTIC Science & Technology

2015-05-01

by David Harman , Scott Brown, Brian Henz, and Lisa M Marvel Approved for public release; distribution unlimited...Laboratory A Communication Protocol for CyAMS and the Cyber Fighter Associate Interface by David Harman College Qualified Leaders Student...CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) David Harman , Scott Brown, Brian Henz, and Lisa M Marvel 5d. PROJECT

State Summary of Soil and Groundwater Cleanup Standards for Hydrocarbons

DTIC Science & Technology

1993-11-15

821096-01 November 15, 1993 19970425 057 !DISTfRIBUTI STýA-TEM,_ Approved for public release; Distribution Unlbfited Product - Paranmeter/ Lab Test ...Env-mmenal Mantagemen, 20-270-5613 Product Parameter/ Lab Test Protocol Detection Notification Action Clean-up Level Constituent & Number Level Level...Envi-mnentai Managament, 205-270-.5613 Su m r of Alsk Clanu Sadr s fo Hyrcro Cotmiae Groundwater Product- - Parameter/ Lab Test Protocol ’Detection

The Ideals of Today’s Modernizing People’s Liberation Army

DTIC Science & Technology

2010-06-01

Government. IRB Protocol number ___N/A_____________. 12a. DISTRIBUTION / AVAILABILITY STATEMENT Approved for public release; distribution is unlimited...was a tutor and teacher for the children of the de facto ruler of Lu, Meng Xizi, where he taught ritual etiquette observed at state religious...appropriately to one’s circumstances and role. One must observe the proper rituals, ceremonies, and protocols to promote social cohesion and individual

Trauma surgeon becomes consultant: evaluation of a protocol for management of intermediate-level trauma patients.

PubMed

Fallon, Sara C; Delemos, David; Christopher, Daniel; Frost, Mary; Wesson, David E; Naik-Mathuria, Bindi

2014-01-01

At our level 1 pediatric trauma center, 9-54 intermediate-level ("level 2") trauma activations are received per month. Previously, the surgery team was required to respond to and assume responsibility for all patients who had "level 2" trauma activations. In 8/2011, we implemented a protocol where the emergency room (ER) physician primarily manages these patients with trauma consultation for surgical evaluation or admission. The purpose of this study was to prospectively evaluate the effects of the new protocol to ensure that patient safety and quality of care were maintained. We compared outcomes of patients treated PRE-implementation (10/2010-7/2011) and POST-implementation (9/2011-5/2012), including surgeon consultation rate, utilization of imaging and laboratory testing, ER length of stay, admission rate, and missed injuries or readmissions. Statistical analysis included chi-square and Student's t-test. We identified 472 patients: 179 in the PRE and 293 in the POST period. The populations had similar baseline clinical characteristics. The surgical consultation rate in the POST period was only 42%, with no missed injuries or readmissions. The ER length of stay did not change. However, in the POST period there were significant decreases in the admission rate (73% to 44%) and the mean number of CT scans (1.4 to 1), radiographs (2.4 to 1.7), and laboratory tests (5.1 to 3.3) ordered in the emergency room (all p<0.001). Intermediate-level pediatric trauma patients can be efficiently and safely managed by pediatric emergency room physicians, with surgical consultation only as needed. The protocol change improved resource utilization by decreasing testing and admissions and streamlining resident utilization in an era of reduced duty hours. © 2014.

Regional Anesthesia and Valproate Sodium for the Prevention of Chronic Postamputation Pain

DTIC Science & Technology

2015-10-01

of Chronic Post -Am utation Pain Research Office Use Onl Continuin Review A roved: A. Study Status at the Durham VAMC: Please choose a response that...data from our other VIPER research grant2, demononstrating a 65% incidence of chronic post -amputation pain. This is consistent with historical...Scope of Practice document. No research may be continued beyond the designated approval period. Date: From: Investigator: Institutional Review Board

The effect of two pre-cryopreservation single layer colloidal centrifugation protocols in combination with different freezing extenders on the fragmentation dynamics of thawed equine sperm DNA

PubMed Central

2012-01-01

Background Variability among stallions in terms of semen cryopreservation quality renders it difficult to arrive at a standardized cryopreservation method. Different extenders and processing techniques (such us colloidal centrifugation) are used in order to optimize post-thaw sperm quality. Sperm chromatin integrity analysis is an effective tool for assessing such quality. The aim of the present study was to compare the effect of two single layer colloidal centrifugation protocols (prior to cryopreservation) in combination with three commercial freezing extenders on the post-thaw chromatin integrity of equine sperm samples at different post-thaw incubation (37°C) times (i.e., their DNA fragmentation dynamics). Results Post-thaw DNA fragmentation levels in semen samples subjected to either of the colloidal centrifugation protocols were significantly lower (p<0.05) immediately after thawing and after 4 h of incubation at 37°C compared to samples that underwent standard (control) centrifugation. The use of InraFreeze® extender was associated with significantly less DNA fragmentation than the use of Botu-Crio® extender at 6 h of incubation, and than the use of either Botu-Crio® or Gent® extender at 24 h of incubation (p<0.05). Conclusions These results suggest that single layer colloidal centrifugation performed with extended or raw semen prior to cryopreservation reduces DNA fragmentation during the first four hours after thawing. Further studies are needed to determine the influence of freezing extenders on equine sperm DNA fragmentation dynamics. PMID:23217215

INTERGROWTH-21st Gestational Dating and Fetal and Newborn Growth Standards in Peri-Urban Nairobi, Kenya: Quasi-Experimental Implementation Study Protocol.

PubMed

Millar, Kathryn; Patel, Suha; Munson, Meghan; Vesel, Linda; Subbiah, Shalini; Jones, Rachel M; Little, Sarah; Papageorghiou, Aris T; Villar, Jose; Wegner, Mary Nell; Pearson, Nick; Muigai, Faith; Ongeti, Catherine; Langer, Ana

2018-06-22

The burden of preterm birth, fetal growth impairment, and associated neonatal deaths disproportionately falls on low- and middle-income countries where modern obstetric tools are not available to date pregnancies and monitor fetal growth accurately. The INTERGROWTH-21 st gestational dating, fetal growth monitoring, and newborn size at birth standards make this possible. To scale up the INTERGROWTH-21 st standards, it is essential to assess the feasibility and acceptability of their implementation and their effect on clinical decision-making in a low-resource clinical setting. This study protocol describes a pre-post, quasi-experimental implementation study of the standards at Jacaranda Health, a maternity hospital in peri-urban Nairobi, Kenya. All women with viable fetuses receiving antenatal and delivery services, their resulting newborns, and the clinicians caring for them from March 2016 to March 2018 are included. The study comprises a 12-month preimplementation phase, a 12-month implementation phase, and a 5-month post-implementation phase to be completed in August 2018. Quantitative clinical and qualitative data collected during the preimplementation and implementation phases will be assessed. A clinician survey was administered eight months into the implementation phase, month 20 of the study. Implementation outcomes include quantitative and qualitative analyses of feasibility, acceptability, adoption, appropriateness, fidelity, and penetration of the standards. Clinical outcomes include appropriateness of referral and effect of the standards on clinical care and decision-making. Descriptive analyses will be conducted, and comparisons will be made between pre- and postimplementation outcomes. Qualitative data will be analyzed using thematic coding and compared across time. The study was approved by the Amref Ethics and Scientific Review Committee (Kenya) and the Harvard University Institutional Review Board. Study results will be shared with stakeholders through conferences, seminars, publications, and knowledge management platforms. From October 2016 to February 2017, over 90% of all full-time Jacaranda clinicians (26/28) received at least one of the three aspects of the INTERGROWTH-21 st training: gestational dating ultrasound, fetal growth monitoring ultrasound, and neonatal anthropometry standards. Following the training, implementation and evaluation of the standards in Jacaranda Health's clinical workflow will take place from March 2017 through March 5, 2018. Data analysis will be finalized, and results will be shared by August 2018. The findings of this study will have major implications on the national and global scale up of the INTERGROWTH-21 st standards and on the process of scaling up global standards in general, particularly in limited-resource settings. RR1-10.2196/10293. ©Kathryn Millar, Suha Patel, Meghan Munson, Linda Vesel, Shalini Subbiah, Rachel M. Jones, Sarah Little, Aris T. Papageorghiou, Jose Villar, Mary Nell Wegner, Nick Pearson, Faith Muigai, Catherine Ongeti, Ana Langer. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.06.2018.

How to design and write a clinical research protocol in Cosmetic Dermatology*

PubMed Central

Bagatin, Ediléia; Miot, Helio A.

2013-01-01

Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. PMID:23539006

25 CFR 518.4 - What criteria must a tribe meet to receive a certificate of self-regulation?

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Establishes or approves, and requires the posting of, rules of games; (xiv) Inspects games, tables, equipment... aids and tests such for compliance with standards; (xvi) Establishes or approves video surveillance...

25 CFR 518.4 - What criteria must a tribe meet to receive a certificate of self-regulation?

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Establishes or approves, and requires the posting of, rules of games; (xiv) Inspects games, tables, equipment... aids and tests such for compliance with standards; (xvi) Establishes or approves video surveillance...

25 CFR 518.4 - What criteria must a tribe meet to receive a certificate of self-regulation?

Code of Federal Regulations, 2013 CFR

2013-04-01

...) Establishes or approves, and requires the posting of, rules of games; (xiv) Inspects games, tables, equipment... aids and tests such for compliance with standards; (xvi) Establishes or approves video surveillance...

25 CFR 518.4 - What criteria must a tribe meet to receive a certificate of self-regulation?

Code of Federal Regulations, 2012 CFR

2012-04-01

...) Establishes or approves, and requires the posting of, rules of games; (xiv) Inspects games, tables, equipment... aids and tests such for compliance with standards; (xvi) Establishes or approves video surveillance...

Dissecting the Mechanisms of Drug Resistance in BRCA1/2-Mutant Breast Cancers

DTIC Science & Technology

2017-10-01

approval from the Institutional Animal Care and Use Committee (IACUC) (protocol # 08-036) for performing Figure 6. NMNAT-1 deficiency rescues...sorted on day 3, and chromosomal aberrations were analyzed by metaphase spreads. 7 all of the proposed animal experiments at site 2, DFCI. The...ACURO documents/forms have been submitted to DOD for approval. The USAMRMC Animal Care and Use Review Office (ACURO) has received the appropriate forms

Integrative Lifecourse and Genetic Analysis of Military Working Dogs

DTIC Science & Technology

2013-10-01

Working Dogs 5b. GRANT NUMBER W81XWH-11-2-0226 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Dr. Kun Huang 5d. PROJECT NUMBER 5e. TASK...we submitted final revisions on our IACUC protocol for the collection of biological samples and Lackland veterinary approval was granted ; and...final Lackland AFB oversight approval was granted and those documents were submitted to DoD CDMRP grant administration. Currently, there is one final

Variables associated with peripherally inserted central catheter related infection in high risk newborn infants 1

PubMed Central

Rangel, Uesliz Vianna; Gomes, Saint Clair dos Santos; Costa, Ana Maria Aranha Magalhães; Moreira, Maria Elisabeth Lopes

2014-01-01

OBJECTIVE: to relate the variables from a surveillance form for intravenous devices in high risk newborn infants with peripherally inserted central catheter related infection. METHODOLOGY: approximately 15 variables were studied, being associated with peripherally inserted central catheter related infection, this being defined by blood culture results. The variables analyzed were obtained from the surveillance forms used with intravenous devices, attached to the medical records of newborn infants weighing between 500 and 1,499 g. The statistical association was defined using the Chi-squared and Student t tests. The study was approved by the Research Ethics Committee of the Instituto Fernandes Figueira under process N. 140.703/12. RESULTS: 63 medical records were analyzed. The infection rate observed was 25.4%. Of the variables analyzed, only three had a statistically-significant relationship with the blood culture - the use of drugs capable of inhibiting acid secretion, post-natal steroid use, and undertaking more than one invasive procedure (p-value of 0.0141, 0.0472 and 0.0277, respectively). CONCLUSION: the absence of significance of the variables of the form may be related to the quality of the records and to the absence of standardization. It is recommended that the teams be encouraged to adhere to the protocol and fill out the form. PMID:25493681

A two-step dilution tris-egg yolk extender containing Equex STM significantly improves sperm cryopreservation in the African wild dog (Lycaon pictus).

PubMed

Van den Berghe, Femke; Paris, Monique Christina Johanna; Briggs, Michael Brent; Farstad, Wenche Kristin; Paris, Damien Boyd Bertrand Paul

2018-02-01

Conservation management of endangered African wild dogs (AWD; Lycaon pictus) can benefit greatly from development of sperm freezing and artificial insemination. Previous freezing attempts yielded nearly 0% motile sperm within 2 h of thawing. In this study, two canine freezing protocols were tested: Protocol 1: a one-step dilution in TRIS-20% egg yolk containing 8% glycerol; and Protocol 2: a two-step dilution in TRIS-20% egg yolk containing a final extender concentration of 5% glycerol and 0.5% Equex STM, coupled with a TRIS-citrate-fructose thawing solution. Semen was collected by electroejaculation from n = 24 AWDs, of which eight ejaculates of sufficient quality (four good quality with initial sperm motility of 75.0 ± 4.4% and four poor quality; showing rapid decrease in sperm motility to 3.3 ± 3.3% prior to freezing) were frozen. For good quality samples, motility and sperm motility index persisted for up to 8 h for Protocol 2, and was higher between 2 and 6 h after thawing with a decrease from 4 h of incubation. Motility dropped to nearly 0% after 2 h incubation for Protocol 1. Viability was higher for Protocol 2 throughout the 8 h of incubation, with a decrease after 6 h, compared to 4 h for Protocol 1. Acrosome integrity was higher for Protocol 2 throughout post-thaw incubation, with a decrease after 2 h for both protocols. Protocols did not differ in normal sperm morphology or DNA integrity. Poor quality samples yielded similar results, except for acrosome integrity, which declined for Protocol 2. In conclusion, a two-step dilution in TRIS-egg yolk-glycerol extender containing Equex STM yields significantly improved post-thaw quality and longevity of AWD spermatozoa, making it suitable for sperm banking and artificial insemination initiatives. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Care of pediatric tracheostomy in the immediate postoperative period and timing of first tube change.

PubMed

Lippert, Dylan; Hoffman, Matthew R; Dang, Phat; McMurray, J Scott; Heatley, Diane; Kille, Tony

2014-12-01

To analyze the safety of a standardized pediatric tracheostomy care protocol in the immediate postoperative period and its impact on tracheostomy related complications. Retrospective case series. Pediatric patients undergoing tracheotomy from February 2010-February 2014. In 2012, a standardized protocol was established regarding postoperative pediatric tracheostomy care. This protocol included securing newly placed tracheostomy tubes using a foam strap with hook and loop fastener rather than twill ties, placing a fresh drain sponge around the tracheostomy tube daily, and performing the first tracheostomy tube change on postoperative day 3 or 4. Outcome measures included rate of skin breakdown and presence of a mature stoma allowing for a safe first tracheostomy tube change. Two types of tracheotomy were performed based on patient age: standard pediatric tracheotomy and adult-style tracheotomy with a Bjork flap. Patients were analyzed separately based on age and the type of tracheotomy performed. Thirty-seven patients in the pre-protocol group and 35 in the post-protocol group were analyzed. The rate of skin breakdown was significantly lower in the post-protocol group (standard: p=0.0048; Bjork flap: p=0.0003). In the post-protocol group, all tube changes were safely accomplished on postoperative day three or four, and the stomas were deemed to be adequately matured to do so in all cases. A standardized postoperative pediatric tracheostomy care protocol resulted in decreased rates of skin breakdown and demonstrated that pediatric tracheostomy tubes can be safely changed as early as 3 days postoperatively. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Greater impact of acute high-intensity interval exercise on post-exercise executive function compared to moderate-intensity continuous exercise.

PubMed

Tsukamoto, Hayato; Suga, Tadashi; Takenaka, Saki; Tanaka, Daichi; Takeuchi, Tatsuya; Hamaoka, Takafumi; Isaka, Tadao; Hashimoto, Takeshi

2016-03-01

Aerobic moderate-intensity continuous exercise (MCE) can improve executive function (EF) acutely, potentially through the activation of both physiological and psychological factors. Recently, high-intensity interval exercise (HIIE) has been reported to be more beneficial for physical adaptation than MCE. Factors for EF improvement can potentially be more enhanced by HIIE than by MCE; but the effects of HIIE on EF remain unknown. Therefore, we aimed to examine to what extent HIIE impacts post-exercise EF immediately after exercise and during post-exercise recovery, compared with traditional MCE. Twelve healthy male subjects performed cycle ergometer exercise based on either HIIE or MCE protocols in a randomized and counterbalanced order. The HIIE protocol consisted of four 4-min bouts at 90% of peak VO2 with 3-min active recovery at 60% of peak VO2. A volume-matched MCE protocol was applied at 60% of peak VO2. To evaluate EF, a color-words Stroop task was performed pre- and post-exercise. Improvement in EF immediately after exercise was the same for the HIIE and MCE protocols. However, the improvement of EF by HIIE was sustained during 30 min of post-exercise recovery, during which MCE returned to the pre-exercise level. The EF response in the post-exercise recovery was associated with changes in physiological and psychological responses. The present findings showed that HIIE and MCE were capable of improving EF. Moreover, HIIE could prolong improvement in EF during post-exercise recovery. For the first time, we suggest that HIIE may be more effective strategy than MCE for improving EF. Copyright © 2015 Elsevier Inc. All rights reserved.

Announcements under Renewable Fuel Standard

EPA Pesticide Factsheets

RFS program announcements are posted below by the calendar year in which the action was posted. Announcements will include rulemakings, responses to petitions, new pathway approvals, compliance deadlines, alternative plans, and among others.

Effects of different five-day progesterone-based fixed-time AI protocols on follicular/luteal dynamics and fertility in dairy cows

PubMed Central

GARCIA-ISPIERTO, Irina; LÓPEZ-GATIUS, Fernando

2014-01-01

This study compares in two experiments the responses of lactating dairy cows to four different progesterone-based protocols for fixed-time artificial insemination (FTAI) in terms of their effects on follicular/luteal dynamics and fertility. The protocols consisted of a progesterone intravaginal device fitted for five days, along with the administration of different combinations of gonadotropin releasing hormone, equine chorionic gonadotropin and a single or double dose (24 h apart) of prostaglandin F2α. In Experiment I, the data were derived from 232 lactating cows. Binary logistic regression identified no effects of treatment on ovulation failure or multiple ovulation 10 days post artificial insemination (AI). Based on the odds ratio, the likelihood of ovulation failure was lower (by a factor of 0.1) in cows showing at least one corpus luteum (CL) upon treatment than in cows lacking a CL; repeat breeders (> 3 AI) and cows with multiple CLs at treatment showed lower (by a factor of 0.44) and higher (by a factor of 9.0) risks of multiple ovulation, respectively, than the remaining animals. In Experiment II, the data were derived from 5173 AIs. The independent variable treatment failed to affect the conception rate 28–34 days post AI, twin pregnancy or early fetal loss 58–64 days post AI. The results of this study demonstrate the efficacy of 5-day progesterone-based protocols for FTAI. All four protocols examined were able to induce ovulation in both cyclic and non-cyclic animals so that FTAI returned a similar pregnancy rate to spontaneous estrus. Our results suggest that the ovarian response and fertility resulting from each treatment are due more to the effect of ovarian structures at treatment than to the different combinations of hormones investigated. PMID:25196275

[Constraints on publication rights in industry-initiated clinical trials--secondary publication].

PubMed

Gøtzsche, Peter C; Hróbjartsson, Asbjørn; Johansen, Helle Krogh; Haahr, Mette T; Altman, Douglas G; Chan, An-Wen

2006-06-19

In 22 of 44 industry-initiated clinical trial protocols from 1994-95, it was noted that the sponsor either owned the data or needed to approve the manuscript; another 18 protocols had other constraints. Furthermore, in 16 trials, the sponsor had access to accumulating data, and in an additional 16 trials the sponsor could stop the trial at any time, for any reason. These facts were not noted in any of the trial reports. We found similar constraints on publication rights in 44 protocols from 2004. This tight sponsor control over industry-initiated trials should be changed.

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

PubMed

Kasenda, Benjamin; von Elm, Erik; You, John J; Blümle, Anette; 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; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

2016-06-01

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, statements can be discrepant with the trial protocol.

Assessment of Habitual Diners Nutrient Intake in a Military-Operated Garrison Dining Facility Fort Devens 1

DTIC Science & Technology

1988-11-01

Human Subjects participated in these studies after giving their free and informed voluntary consent. Investigators adhered to AR 70-25 and USAMRDC...diet and nutrition, abstinence from tobacco products, smoking cessation, avoidance of substance abuse, and stress management. A renewed interest in...a Volunteer Agreement in accordance with the approved Human Use protocol. Demographic questionnaires (Appendix C) which included information about

Telecommunications Policy in the Caribbean: A Case Study of Telecommunications in Jamaica and Cuba

DTIC Science & Technology

2013-03-01

official policy or position of the Department of Defense or the U.S. Government . IRB Protocol number ____N/A____. 12a. DISTRIBUTION / AVAILABILITY...STATEMENT Approved for public release; distribution is unlimited 12b. DISTRIBUTION CODE A 13. ABSTRACT (maximum 200 words) Government influence and...nation’s ideology will dictate how governments interact with telecommunications providers and, ultimately, the telecommunications company’s ability to

Cyclosporine A at reperfusion fails to reduce infarct size in the in vivo rat heart.

PubMed

De Paulis, Damien; Chiari, Pascal; Teixeira, Geoffrey; Couture-Lepetit, Elisabeth; Abrial, Maryline; Argaud, Laurent; Gharib, Abdallah; Ovize, Michel

2013-09-01

We examined the effects on infarct size and mitochondrial function of ischemic (Isch), cyclosporine A (CsA) and isoflurane (Iso) preconditioning and postconditioning in the in vivo rat model. Anesthetized open-chest rats underwent 30 min of ischemia followed by either 120 min (protocol 1: infarct size assessment) or 15 min of reperfusion (protocol 2: assessment of mitochondrial function). All treatments administered before the 30-min ischemia (Pre-Isch, Pre-CsA, Pre-Iso) significantly reduced infarct as compared to control. In contrast, only Post-Iso significantly reduced infarct size, while Post-Isch and Post-CsA had no significant protective effect. As for the postconditioning-like interventions, the mitochondrial calcium retention capacity significantly increased only in the Post-Iso group (+58 % vs control) after succinate activation. Only Post-Iso increased state 3 (+177 and +62 %, for G/M and succinate, respectively) when compared to control. Also, Post-Iso reduced the hydrogen peroxide (H2O2) production (-46 % vs control) after complex I activation. This study suggests that isoflurane, but not cyclosporine A, can prevent lethal reperfusion injury in this in vivo rat model. This might be related to the need for a combined effect on cyclophilin D and complex I during the first minutes of reperfusion.

Sport-specific functional movement can simulate aspects of neuromuscular fatigue occurring in team sports.

PubMed

Wilke, Jan; Fleckenstein, Johannes; Krause, Frieder; Vogt, Lutz; Banzer, Winfried

2016-06-01

Fatigue protocols have been used over the years to examine muscular exhaustion. As an alternative to approaches in laboratory settings, functional agility protocols claiming to mimic the multifaceted loads of athletic activity have been proposed. This study aimed to examine the effects of a functional agility short-term fatigue protocol (FAST-FP) on neuromuscular function. Twenty-eight healthy sports students (15 males, aged 24.3 ± 2.4 years) completed the FAST-FP, which consists of four components: three counter-movement jumps (90% of individual maximum), a 20-s bout of step-ups, three bodyweight squats and an agility run. Tasks were repeated until the participants no longer achieved the required jump height in two consecutive sets. Outcomes (pre-post) encompassed subjective exhaustion (visual analogue scale [VAS]), maximum isometric voluntary force of the knee extensors (MIVF), reactive strength index (RSI), mean power frequency (MPF, measured using surface electromyography) and maximum knee range of motion (ROM). Post-intervention, VAS (+54 mm) increased significantly, while MIVF (-6.1%), RSI (-10.7%) and MPF (-4.1%) were reduced (p < 0.05). No changes were observed for ROM (p > 0.05). The FAST-FP induces small-to-moderate impairments in neuromuscular function and considerable self-perceived fatigue. Current evidence on exhaustion developing in team sports suggests that this magnitude of fatigue is similar. The protocol might thus be valuable in the evaluation of treatments counteracting post-match fatigue in team sports.

A functional agility short-term fatigue protocol changes lower extremity mechanics

PubMed Central

Cortes, Nelson; Quammen, David; Lucci, Shawn; Greska, Eric; Onate, James

2012-01-01

The purpose of this study was to evaluate the effects of a functional agility fatigue protocol on lower extremity biomechanics between two unanticipated tasks (stop-jump and sidestep). The subjects consisted of fifteen female collegiate soccer athletes (19 ± 0.7 years, 1.67 ± 0.1 m, 61.7 ± 8 kg) free of lower extremity injury. Participants performed five trials of stop-jump and sidestep tasks. A functional short-term agility protocol was performed, and immediately following participants repeated the unanticipated running tasks. Lower extremity kinematic and kinetic values were obtained pre and post fatigue. Repeated measures analyses of variance were conducted for each dependent variable with an alpha level set at 0.05. Knee position post-fatigue had increased knee internal rotation (11.4 ± 7.5° vs. 7.9 ± 6.5° p = 0.011) than pre-fatigue, and a decreased knee flexion angle (−36.6 ± 6.2° vs.−40.0 ± 6.3°, p = 0.003), as well as hip position post-fatigue had decreased hip flexion angle (35.5 ± 8.7° vs. 43.2 ± 9.5°, p = 0.002). A quick functional fatigue protocol altered lower extremity mechanics of Division I collegiate soccer athletes during landing tasks. Proper mechanics should be emphasized from the beginning of practice/game to aid in potentially minimizing the effects of fatigue in lower extremity mechanics. PMID:22424559

A Novel EphA4-Based Small Molecule-Based Therapeutic Strategy for Prevention and Treatment of Post-Traumatic Osteoarthritis

DTIC Science & Technology

2015-09-01

first three months of the project, we successfully obtained approval for our Animal Component of Research Project (ACORP) from our local IACUC and...total number of animals . The approved ACORP and the amendment were submitted to ACURO for approval and final approval from the ACURO was secured on...the tibial plateau. The injury was produced using an “Instron” servohydraulic tester with the animal under inhalation anesthesia (3% isoflurane, 0.5

Assessment tools for the measurement of the self-efficacy of drug users: protocol for a systematic review.

PubMed

Vasconcelos, Selene Cordeiro; Frazão, Iracema da Silva; Sougey, Everton Botelho; Souza, Sandra Lopes de; Silva, Tatiana de Paula Santana da; Lima, Murilo Duarte da Costa

2018-03-14

The abuse of alcohol and other drugs is a worldwide problem, the treatment of which poses a challenge to healthcare workers. This study presents a proposal for a systematic review to analyse the psychometric properties of assessment tools developed to measure the self-efficacy of drug users with regard to resisting the urge to take drugs in high-risk situations. The guiding question was based on PICOS (Population Intervention Comparator Outcome Setting), and the report of the methods of review protocol was written in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Searches will be performed in the PsycINFO, Cochrane, Pubmed, Web of Science, SCOPUS and CINAHL databases, followed by the use of the 'snowball' strategy. The inclusion criteria for the articles will be (1) assessment tool validation studies; (2) assessment tools developed to measure self-efficacy; (3) quantitative measures; (4) measures designed for use on adults; (5) data from self-reports of the participants; (6) studies involving a description of psychometric properties of the measures; and (7) studies that explain how the level of self-efficacy is scored. The search, selection and analysis will be performed by two independent reviewers. In cases of a divergence of opinion, a third reviewer will be consulted. The COSMIN checklist will be used for the appraisal of the methodological quality of the assessment tools and the certainty of the evidence in the articles (risk of bias) will be analysed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. This protocol does not require ethical approval. However, this protocol is part of the thesis entitled Drug-Taking Confidence Questionnaire for use in Brazil, presented for obtaining a doctorate in neuropsychiatry and behavioural sciences from the Federal University of Pernambuco, and has received approval from the human research ethics committee of the Federal University of Pernambuco (reference number: 1.179.162).The results will be disseminated to clinicians and researchers through peer-reviewed publications and conferences. CRD42017068555. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

40 CFR 265.145 - Financial assurance for post-closure care.

Code of Federal Regulations, 2013 CFR

2013-07-01

... of this section in accordance with § 265.145(h). (e) Financial test and corporate guarantee for post... closure and post-closure cost estimates to be covered by the test; (iv) Specify the date ending the owner... Regional Administrator may approve a decrease in the current post-closure cost estimate for which this test...

40 CFR 265.145 - Financial assurance for post-closure care.

Code of Federal Regulations, 2010 CFR

2010-07-01

... of this section in accordance with § 265.145(h). (e) Financial test and corporate guarantee for post... closure and post-closure cost estimates to be covered by the test; (iv) Specify the date ending the owner... Regional Administrator may approve a decrease in the current post-closure cost estimate for which this test...

40 CFR 265.145 - Financial assurance for post-closure care.

Code of Federal Regulations, 2012 CFR

2012-07-01

... of this section in accordance with § 265.145(h). (e) Financial test and corporate guarantee for post... closure and post-closure cost estimates to be covered by the test; (iv) Specify the date ending the owner... Regional Administrator may approve a decrease in the current post-closure cost estimate for which this test...

40 CFR 265.145 - Financial assurance for post-closure care.

Code of Federal Regulations, 2014 CFR

2014-07-01

... of this section in accordance with § 265.145(h). (e) Financial test and corporate guarantee for post... closure and post-closure cost estimates to be covered by the test; (iv) Specify the date ending the owner... Regional Administrator may approve a decrease in the current post-closure cost estimate for which this test...

40 CFR 265.145 - Financial assurance for post-closure care.

Code of Federal Regulations, 2011 CFR

2011-07-01

... of this section in accordance with § 265.145(h). (e) Financial test and corporate guarantee for post... closure and post-closure cost estimates to be covered by the test; (iv) Specify the date ending the owner... Regional Administrator may approve a decrease in the current post-closure cost estimate for which this test...

14 CFR § 1264.135 - Post-hearing briefs.

Code of Federal Regulations, 2014 CFR

2014-01-01

... PROGRAM FRAUD CIVIL PENALTIES ACT OF 1986 § 1264.135 Post-hearing briefs. The presiding officer may require the parties to file post-hearing briefs. In any event, upon approval of the presiding officer, any... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false Post-hearing briefs. § 1264.135 Section Â...

45 CFR 602.30 - Changes.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION UNIFORM ADMINISTRATIVE... approved project. However, unless waived by the awarding agency, certain types of post-award changes in budgets and projects shall require the prior written approval of the awarding agency. (b) Relation to cost...

45 CFR 602.30 - Changes.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION UNIFORM ADMINISTRATIVE... approved project. However, unless waived by the awarding agency, certain types of post-award changes in budgets and projects shall require the prior written approval of the awarding agency. (b) Relation to cost...

45 CFR 602.30 - Changes.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION UNIFORM ADMINISTRATIVE... approved project. However, unless waived by the awarding agency, certain types of post-award changes in budgets and projects shall require the prior written approval of the awarding agency. (b) Relation to cost...