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A Pilot Study of Urinary Carcinogen Biomarkers in the Golestan Cohort Study
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Research Initiative
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CDC, FDA
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NCI
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A pilot study in the Golestan Cohort to compare exposure to different types of carcinogens (nicotine metabolites, polycyclic aromatic hydrocarbons [PAHs], tobacco-specific nitrosamines [TSNAs], and volatile organic compounds [VOCs]) and creatine in the urine of self-reported cigarette, chewing nass, water pipe, and opium users, and never users of these products. The study will examine the stability of these markers over time by taking advantage of repeated samples that were collected from a subset of participants. Results from the pilot study will then be used to evaluate the potential of future studies and evaluate their design.
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A Study of Markers of Cosmic Radiation Exposure and Effect Among Flight Crews
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Research Initiative
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CDC
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NCI
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NCI and CDC are collaborating on a cross-sectional study of 83 airline pilots and 50 university faculty to assess the relation of stable chromosome translocations with cosmic radiation exposure.
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A Working Group to Consider the Question of Federal Public Health and Medical Resource Allocation
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Committee, Work group, Advisory group, or Task Force
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OS
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CC
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THe NIH Clinical Center 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.
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A5349/TBTC S31 - Rifapentine - Containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-Label, Controlled Phase 3 Clinical Trial
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Research Initiative
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CDC
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NIAID
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The purpose of this research initiative is to provide scientific discovery to improve patient care and safety by reducing the duration of treatment for drug-susceptible pulmonary tuberculosis to 4 months by using new regimens, including high-dose rifapentine.
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Abuse Liability Evaluation for Research, Treatment, and Training (ALERTT)
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Research Initiative
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FDA
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NIDA
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Abuse Liability Evaluation for Research, Treatment, and Training (ALERTT) is part 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). The mission of the (ACTTION) 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.
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Accelerating Medicines Partnership
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Other
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FDA
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OD/OSP, NIA, NIAMS, NIDDK
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The Accelerating Medicines Partnership (AMP) is a public-private partnership, between NIH, FDA, 10 biopharmaceutical companies and multiple non-profit organizations, and managed by the Foundation for NIH (FNIH), to transform the current model for developing new diagnostics and treatments by jointly identifying and validating promising biological targets for therapeutics. The ultimate goal is to increase the number of new diagnostics and therapies for patients and reduce the time and cost of developing them. AMP was launched in February 2014, with projects in three disease areas (Alzheimer’s disease; type 2 diabetes; and autoimmune disorders of rheumatoid arthritis and systemic lupus erythematous). Steering committees for each of the three disease areas, with representation from all partners, meet regularly to review ongoing progress and milestones. The steering committees are managed by FNIH under the direction of an AMP Executive Committee comprised of representatives from NIH, participating industry leaders, FDA, and non-profit organizations.
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AccessGUDID
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Resource Development
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FDA
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NLM
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The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). The National Library of Medicine (NLM), in collaboration with the FDA, has created the AccessGUDID portal to make device identification information in the GUDID available for everyone, including patients, caregivers, health care providers, hospitals, and industry.
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Action for Health in Diabetes (Look AHEAD)
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Research Initiative
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CDC, IHS
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NIDDK, NHLBI
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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.
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Action Plan for Children in Adversity (APCA)/PL 109-95
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Committee, Work group, Advisory group, or Task Force
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ACF, CDC, HRSA
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NICHD
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The Action Plan on Children in Adversity is the first-ever whole-of-government strategic guidance for U.S. Government international assistance for children. The goal of the U.S. Government Action Plan on Children in Adversity is to achieve a world in which all children grow up within protective family care and free from deprivation, exploitation, and danger. The plan is grounded in evidence that shows a promising future belongs to those nations that invest wisely in their children, while failure to do so undermines social and economic progress. Child development is a cornerstone for all development, and it is central to U. S. development and diplomatic efforts. The plan seeks to integrate internationally recognized, evidence-based good practices into all of its international assistance initiatives for the best interests of the child. The Action Plan has three principal objectives and three supporting objectives to promote greater U.S. Government coherence and accountability for whole-of-government assistance to vulnerable children.
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Addiction Technology Transfer Centers (ATTCs)
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Resource Development
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SAMHSA
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NIDA
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Accelerating the dissemination of research-based drug abuse treatment into clinical practice is a priority for the National Institute on Drug Abuse (NIDA) and represents the core mission of the Blending Initiative. NIDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) joined together to create the Blending Initiative in 2001 to reduce the gap that exists between the publication of research results and impact on treatment delivery. This initiative incorporates collaboration between clinicians, scientists, and experienced trainers to catalyze the creation of user-friendly treatment tools and products and facilitate the adoption of research-based interventions into front-line clinical settings. Through this initiative, NIDA and SAMHSA’s Addiction Technology Transfer Centers (ATTCs) disseminate treatment and training products based on results from studies conducted by the National Drug Abuse Clinical Trials Network (CTN) as well as other NIDA-supported research.
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