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Warning You have reached the maximum number of saved studies Prognostic Value of P30 After Cardiac Arrest The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : May 14, Study Description. This study aims to examine whether P30 wave of somatosensory evoked potentials SEP is related with outcome after cardiac arrest.

The study design is a prospective, multicenter-observational study. Patients survived after out-of-hospital cardiac arrest undergoing hypothermic-targeted temperature management will participate in the study. Relationship of P30 wave of SEP with the neurologic outcome on hospital discharge will be evaluated. Detailed Description:. The absence of N20 of the somatosensory evoked potentials SEP is recommended as a valuable predictor of poor neurologic outcome in post-cardiac arrest patients. However, interpretation of N20 is affected by the background noise levels.

Reliable analysis of N20 is limited with high noise levels and artifacts. Moreover, presence of N20 does not guarantee good neurologic outcome. P30 is a positive deflection of N20 occurring on msec. According to our pilot study, N20 without following P30 is related with poor outcome, while N20 followed by P30 is highly related with good outcome.

P30 is evident even when the N20 is ambiguous in patients with good outcome. We hypothesized that the negative-positive deflection of NP30 components is more valuable predictor than the N20 alone. In this observational study, we will identify whether presence of P30 checked on 24 and 72 hours after cardiac arrest predicts neurologic outcome more accurately than the presence of N20 alone. FDA Resources.

Intervention Details: Device: Somatosensory evoked potential Somatosensory evoked potential on 24, 72 hours after cardiac arrest. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Out-of-hospital cardiac arrest patients undergoing hypothermic-targeted temperature management in the four academically affiliated tertiary care centers.

Inclusion Criteria: Comatose survivors after out-of-hospital cardiac arrest Exclusion Criteria: Not treated by hypothermic-targeted temperature management.

Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. Each proposed technique or service in the Research Support Core, and its current status of staffing, should be described in enough detail to allow a comprehensive evaluation. Existing methodologies already in use may be described briefly; methodologies new to the institution need to be described in greater detail and strategies delineated for successful implementation.

Include any developmental methods for research or training, if proposed. If applicable, include sections on quality control. Include plans for administration, organization and proposed management of the Research Support Core. Administrative organization is a critical part of the application. Include plans to implement core services, prioritize investigator use among projects competing for core use, and how potential disputes will be resolved.

If the core is used to train investigators in special techniques, describe the nature and extent of this training and the qualifications of core personnel to provide and oversee this training. Specifically address the strategies for integrating the resources of the Research Support Cores with resources already provided to the research base. Describe how this integration of resources expands the capability of the research base.

Specific Aims: Specific Aims are required. Describe how these Pilot Research Projects will enhance the Center and foster new research. Research Strategy: Applicants may propose and request funding in the first year for specific, already conceptualized pilot projects and also for pilot projects to be added in subsequent years of the project. Applications requesting support for pilot projects must describe a process for within-Center scientific review of new pilot projects to be initiated in future years of the project and a process for evaluation of ongoing pilot projects for adequate progress.

The application may also describe each pilot project proposed for the initial year of support. Pilot projects presented in the application will be reviewed as part of the assessment of scientific and technical merit of the application and as examples of the kinds of pilot projects the Center might initiate in the future as a result of its internal within-Center review process.

Pilot projects may be used for new, early stage or independent investigators and should represent new projects to develop and explore new activities or directions or take advantage of special opportunities. Pilot projects may not be used to supplement or prolong ongoing research and should not be used as bridge funds when other research support is no longer available.

The support of individual pilot project studies is typically of relatively short duration e. Center grantees are expected to provide NIDA program staff with a description and justification of any pilot project before initiating it.

The notification should contain a brief description of, and rationale for, the planned pilot project, the amount of pilot funds to be allocated to the project, the proposed length of the project, and a statement that the project will comply with applicable NIH policies and that the necessary assurances have been submitted and obtained. The program officer should also be provided with assurance that the projects have received an appropriate within-Center review.

Applicants are strongly encouraged to discuss with the program officer to ensure that the pilot project stays within the original scope. For all pilot projects, describe the internal institutional plans and procedures to ensure that all projects supported from this award will comply fully with all applicable Federal regulations, policies, and guidelines for research involving human subjects, including the evaluation of risks and protections in project proposals, appropriate ethical oversight and funded projects, and plans for data and safety monitoring for clinical trials, if applicable.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. Organizations must submit applications to Grants. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

This initiative is not subject to intergovernmental review. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

See more tips for avoiding common errors. Applications that are incomplete will not be reviewed. Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD Only the review criteria described below will be considered in the review process. As part of the NIH mission , all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field s involved, in consideration of the following review criteria and additional review criteria as applicable for the Center proposed.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

For example, a project that by its nature is not innovative may be essential to advance a field. Does the Center address an important problem or a critical barrier to progress in the field? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is there a clear integration of the Center components -Cores and Projects- to an overarching theme that integrates and focuses the Center, as well as the presence of an essential relationship of each research project and core component to the theme?

If present, are translational components well designed to enhance potential collaborations leading to public health advances? How well does each individual core fit in and contribute to the overall Core Center?

How relevant and interrelated are the separately funded ongoing research projects to the central theme of the Core Center of Excellence? How likely is it that meaningful collaborations are going to be established between the Core Center and the greater substance abuse research community?

How likely are the Pilot projects to bring in Early-Stage Investigators, bring in established investigators new to substance abuse research or permit established investigators to change research directions? How do the proposed Enrichment Program activities, such as use of seminars, visiting scientists, workshops and use of consultants, contribute to the objectives of the NIDA Core Center of Excellence?

If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field s? Does the Center Director have the ability to lead a scientific program as documented by scientific achievements, productivity, stature in a relevant field, and planned activities?

Does the Center Director have the ability to lead administrative and operational aspects of the Center, as noted by administrative skills, achievements, and planned activities and is there evidence of ability to develop or maintain a role for the Center as a national resource? Is there adequate commitment of time and effort for the research and administrative functions of the Center?

As a group, are Research Project and Core investigators well suited to the projects? Is there evidence of multidisciplinary backgrounds and interests? Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?

Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the Core Center use innovative ways to communicate, to allocate resources, to promote new cross-departmental or multi-disciplinary collaborations, or to integrate activity among the research cores or across basic and clinical fields?

How will each individual core contribute to the innovation of the overall Core Center? Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Does the application clearly demonstrate, in a diagram, the feasibility of the organizational structure?

Does the organizational structure have clear lines of authority that allow for efficient and cost-effective management and allocation of funds, as well as leverage of resources to enable additional or future work?

Are the organizational and administrative structure and support capable of creating thematic integration that is conducive to research, synergy, and joint planning? Is there an operational programmatic structure that effectively promotes productive scientific interactions, cross fertilization, and takes maximum advantage of the applicant institution's drug abuse research capacity? Are the research support cores well integrated into the Core Center? Are there plans to establish and maintain communication and cooperation among the Center investigators?

Are there adequate administrative management plans for the Core Center and the research support cores, including implementation, allocation, user prioritization, quality control and utilization of services?

How well do the management plans address accountability, flow of authority, dispute resolution, evaluation and integration with the home institution fiscal and academic administration? Is appropriate administrative organization proposed for the following: a coordination of ongoing research between the separately funded projects and the Center, including mechanisms for internal monitoring; b establishment and maintenance of internal communication and cooperation among the Center investigators; c mechanism for selecting and replacing professional or technical personnel within the cores; d mechanism for reviewing the use of, and administering funds for, the pilot project program; and e management capabilities, including fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities?

Is a process in place for long range planning and evaluation of Center activities? Is there an appropriate, fully described internal process that allows for priority setting and decision making to sustain the Center? Is there appropriate specification of criteria and processes for determining and sustaining individual participation in the Center based on productivity, research direction, and overall contribution? Are there arrangements for internal quality control of research, publications, and grant applications?

Does the outside advisory structure have the capacity to provide appropriate and objective advice and evaluation? Are there adequate plans for recruitment, training, and supervision of staff? Will at least two federally funded research investigators use each core and how significant will their use be?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Are there plans for development and maintenance of an environment that promotes the conduct of the highest quality of research, innovation, and leadership?

Does past productivity indicate likely future productivity, especially in renewal applications, where innovation needs to be demonstrated? Are there appropriate and adequate facilities for administrative, research, and shared resources, including a clearly identifiable physical location for the Center, which assures necessary functions can occur?

Do the facilities indicate the Center is, or would soon be, a national scientific research resource? Is there adequate institutional support; for example, letters of support, space and resources to be allocated from the applicant institution, substantial commitment to the Center and appreciation of its goals and role in public health, especially in the drug abuse and addiction research field?

Does the environment provide adequate high quality data analytic capacity, data base facilities, coordination, and data resources?

As needed, are there provisions for shared laboratory resources, high quality laboratory space, and clinical facilities? As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1 risk to subjects, 2 adequacy of protection against risks, 3 potential benefits to the subjects and others, 4 importance of the knowledge to be gained, and 5 data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1 the justification for the exemption, 2 human subjects involvement and characteristics, and 3 sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section. For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Renewals, the committee will consider the progress made in the last funding period. For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

If a new core is proposed, reviewers will evaluate the supplemental core in the context of the overall P30 and the appropriateness of administrative oversight. As applicable for the Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Reviewers will assess the information provided in this section of the application, including 1 the Select Agent s to be used in the proposed research, 2 the registration status of all entities where Select Agent s will be used, 3 the procedures that will be used to monitor possession use and transfer of Select Agent s , and 4 plans for appropriate biosafety, biocontainment, and security of the Select Agent s. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group s , convened by the NIDA in accordance with NIH peer review policy and procedures , using the stated review criteria. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board.

The following will be considered in making funding decisions:. A formal notification in the form of a Notice of Award NoA will be provided to the applicant organization for successful applications. Awardees must comply with any funding restrictions described in Section IV. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk.

These costs may be reimbursed only to the extent considered allowable pre-award costs. A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of Transparency Act , includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY or later. We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. TTY: Email: commons od. Jamie Biswas, Ph. Meyer D. Glantz, Ph.

Jonathan D. Pollock, Ph. Steven Grant, Ph. Examine your eRA Commons account for review assignment and contact information information appears two weeks after the submission due date. Recently issued trans-NIH policy notices may affect your application submission.

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. Department of Health and Human Services. Overview Information.

Components of Participating Organizations. Part 2. Full Text of Announcement. Section I. Funding Opportunity Description. Section II.



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