|
2015 Dietary Guidelines Management Team
|
Committee, Work group, Advisory group, or Task Force
|
CDC, FDA
|
NIDDK
|
The Dietary Guidelines Management Team includes federal staff representing the Departments of Health and Human Services and Agriculture throughout the Dietary Guidelines for Americans revision process and supports the Dietary Guidelines Advisory Committee from the planning phase to the final report phase.
|
|
9th NICHD Structural Birth Defects Meeting
|
Meeting/ Workshop
|
CDC
|
NICHD, CSR, NHGRI, NHLBI, NIAAA, NIAMS, NIDCR, NIDDK, NIEHS, NINDS
|
This meeting will bring together 45 researchers funded through the Eunice Kennedy Shriver National Institute of Child Health and Human Development''s (NICHD) Birth Defects Initiatives [PAR-12-034, Developmental Mechanisms of Human Structural Birth Defects (P01) and PA-11-085, Genetic Susceptibility and Variability of Human Structural Birth Defects (R01)], as well as other select NICHD Principal Investigators (PIs) who comprise the Birth Defects Working Group (a total of 56 grantees). The working group is unique in that it includes both basic scientists and clinicians, and the projects they oversee emphasize the translational aspects of birth defects research. These recurring meetings are designed to maintain an interactive special interest working group of investigators who are interested in multidisciplinary approaches to enhancing our understanding of the genetic epidemiology, etiology, pathogenesis, developmental biology, and genetics of structural birth defects. The research areas covered currently include the study of neural tube and other structural central nervous system (CNS) defects, cardiac defects, congenital diaphragmatic hernia, limb defects, skeletal dysplasias, osteogenesis imperfecta, congenital contractures, club foot, Cornelia de Lange Syndrome, pituitary defects, cryptorchidism, and craniofacial defects.
The purpose of the meeting is to provide a forum for the investigators to discuss the plans and progress of their research, exchange ideas and information, share resources, and foster synergistic collaborations relevant to the research goals of the NICHD Birth Defects Initiative. It is also an opportunity for the PIs to provide input and advice to NIH Program Staff. There will be an invited keynote speaker (Liliana Solnica-Krezel, Washington University, St. Louis) and a special round table discussion on tissue morphogenesis and biophysical and biomechanical aspects of embryonic development within the context of understanding normal development and structural birth defects. Representatives from the Centers for Disease Control and Prevention (CDC) Birth Defects Branch, National Heart, Lung, and Blood Institute (NHLBI), National Human Genome Research Institute (NHGRI), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Environmental Health Sciences (NIEHS), National Institute of Neurological Disorders and Stroke (NINDS), NICHD Division of Scientific Review (DSR), and National Institutes of Health (NIH) Center for Scientific Review (CSR) also will be invited.
|
|
A qPCR-Based Approach to Develop Serological Assays for Influenza Virus: Comparison with Other Assays Using Clinical Samples
|
Research Initiative
|
FDA
|
NIAID
|
Currently, the assays to measure immunogenicity of a flu vaccine are serologically based hemagglutinin inhibition and microneutralization assays. The assay results vary across laboratories, making it difficult to compare results across multiple sites. FDA standardized the qPCR based neutralization assay and qualified and tested the assay using human samples and compared it to the currently used method (comparability studies). The assay allows for quantitation of results which could be compared across multiple sites using standardized reagents and could have regulatory impact since results from clinical trials evaluating different vaccine candidates can be compared globally.
|
|
A Study of Markers of Cosmic Radiation Exposure and Effect Among Flight Crews
|
Research Initiative
|
CDC
|
NCI
|
A cross-sectional study of 83 airline pilots and 50 university faculty to assess the relation of stable chromosome translocations with cosmic radiation exposure.
|
|
A Working Group to Consider the Question of Federal Public Health and Medical Resource Allocation
|
Committee, Work group, Advisory group, or Task Force
|
OS
|
CC
|
Dr. Marion Danis is participating in a working group to consider the question of federal public health and medical resource allocation. The group developed a framework for allocation of federal resources during scarcity after engaging with stakeholders in ethics, disaster preparedness, and emergency management.
|
|
A5295 Evaluation of Xpert MTB/RIF Assay for the Rapid Identification of TB and TB Rifampin Resistance in HIV-Infected and HIV-Uninfected Pulmonary Tuberculosis Suspects
|
Research Initiative
|
CDC
|
NIAID
|
This initiative will estimate the sensitivity of a single Xpert MTB/RIF assay (performed on sputum) in TB suspects with at least one acid fast bacilli (AFB) sputum smear positive result and at least one culture result positive for M. tuberculosis.
|
|
Abuse Liability Evaluation for Research, Treatment, and Training (ALERTT)
|
Research Initiative
|
FDA
|
NIDA
|
ALERTT is part of ACTTION - The mission of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration (FDA) is to identify, prioritize, sponsor, coordinate, and promote innovative activities — with a special interest in optimizing clinical trials — that will expedite the discovery and development of improved analgesic, anesthetic, and addiction treatments for the benefit of public health.
|
|
Action for Health in Diabetes (Look AHEAD)
|
Research Initiative
|
CDC, IHS
|
NIDDK, NHLBI
|
This study is a 16-center, randomized clinical trial investigating the long-term health consequences of weight loss. Enrollment occurred between 2001-2004 with a planned follow-up of up to 13.5 years. The Look AHEAD cohort comprises approximately 5,000 overweight or obese participants with type 2 diabetes, aged 45-76. Participants were randomized to one of two interventions: an intensive lifestyle intervention designed to produce and sustain weight loss over the long term or a diabetes support and education arm. The study intervention was discontinued in Sept. 2012 on the recommendation of the Data and Safety Monitoring Board (DSMB), as there were no differences between the two groups after up to 11 years of follow-up. The study will continue to follow participants for study outcomes.
|
|
Action to Control Cardiovascular Risk in Diabetes (ACCORD)
|
Research Initiative
|
CDC
|
NHLBI, NIDDK
|
ACCORD was a large clinical study primarily composed of three clinical trials that tested treatment approaches to determine the best ways to decrease the high rate of major cardiovascular disease (CVD) events – heart attack, stroke, or death from CVD – among people with type 2 diabetes who were at especially high risk of having a CVD event.
|
|
Action to Control Cardiovascular Risk in Diabetes (ACCORD) Follow-up Study (ACCORDION) -- Health Related
|
Research Initiative
|
CDC
|
NHLBI
|
The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study was primarily composed of three clinical trials that tested treatment approaches to determine the best ways to decrease the high rate of major cardiovascular disease (CVD) events – heart attack, stroke, or death from CVD – among people with type 2 diabetes who are at especially high risk of having a CVD event, like a heart attack or stroke. ACCORDION (the ACCORD Follow-up Study) is a prospective, observational follow-up study of approximately 8000 participants who were treated and followed in the ACCORD Trial. It is designed to further elucidate and clarify the long-term effects of the ACCORD treatment strategy and provide additional data on the long-term relationships among various cardiovascular and diabetic risk factors. ACCORD participants had type 2 diabetes and were at high risk for a CVD event. Those who agree to participate in ACCORDION will continue to be followed through clinic and phone visits for an average of 3.5 years in the period 2011 through 2014. Participants will be seen in 76 clinics across the United States and Canada. The CDC is contributing intellectually and financially to the Health Related Quality of Life and Cost Effectiveness substudies of the trial.
|