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The goals of this funding opportunity announcement are to support science that will ultimately help: 1) Improve the ability to identify who is at risk for sub-optimal weight loss, weight regain, and short- or long-term adverse metabolic/physiologic or behavioral outcomes based on behavioral or psychological characteristics and 2) Inform the development of new treatment approaches to be used pre and/or post-surgery to minimize risks and improve outcomes or allow for more tailored patient and procedure selection.

The aim of the Conquer Paralysis Now (CPN) Challenge is to accelerate the development of treatments for spinal cord injury (SCI) in order to provide significant improvements in patients' quality of life. Stage I of the Challenge Program was launched in 2014 to provide seed funding to a wide range of non-traditional approaches, and Stage I grants will recur annually. A total of 12 grants, each at least $50,000, are available cross the six categories in each round of Stage I. In all six awards, we are looking for unconventional, novel and disruptive concepts that have the potential for functional recovery in chronic humans and animals.

The purpose of this study is to: 1) collect information on practice patterns in special populations to assess possible barriers to generic substitution ; 2) compare clinical practice (e.g., drug product manipulation prior to administration, co-administration with another food or drug) with labeled drug administration information in the assessed populations to identify factors that raise issues for safety and effectiveness with generic substitution; and 3) analyze the impact of product-level, patient-level, and provider-level factors on generic drug substitution. The outcome of this study will help identify research needs, support FDA's regulatory science efforts to monitor and ensure successful generic substitution, and provide evidence to assure the public on generic drug safety and effectiveness.

This Funding Opportunity Announcement (FOA) solicits applications for the Consortium on Targeting and Regeneration (CTAR) that supports the development of innovative strategies to increase or protect functional human beta cell mass in patients with Type-1 Diabetes (T1D) through the controlled manipulation of beta cell replication, islet cell plasticity, and the reprogramming of pancreatic non-beta cells into beta-like cells, or through shielding the residual beta cell mass from the autoimmune environment. CTAR is part of the Human Islet Research Network (HIRN).

The purpose of this funding opportunity is to identify health care and clinic practices that are associated with the best outcomes for people living with spina bifida (SB) and to communicate and encourage adoption of best practices by SB clinics including providing needed educational/informational resources for the SB patient and provider communities, health care professionals, families, and educators.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational activities and clinical trials to treat pain with innovative, targeted, and non-addictive diagnostic and/or therapeutic devices that improve patient outcomes and decrease or eliminate the need to prescribe opioids. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical trial (e.g., Early Feasibility Study). The clinical trial is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in the development of the project plan and monitoring of research progress. This FOA will leverage Public-Private Partnership Programs (PPP) initiated under the NIH BRAIN Initiative, the Office of Strategic Coordination The Common Funds Stimulating Peripheral Activity to Relieve Conditions (SPARC) Program, and the HEAL Initiative. These programs include agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without the need for significant additional non-clinical data.

The purpose of this FOA is to support the establishment of center(s) that will use cutting edge technologies to perform omics analyses (e.g. metabolomic, lipidomic, proteomic, extracellular RNA) of body fluids collected by the Acute to Chronic Pain Signatures (A2CPS) consortium. The omics data generated, in concert with other patient assessments, will be used to identify biosignatures predictive of susceptibility or resilience to the development of chronic pain.

The purpose of this FOA is to support one Multisite Clinical Center (MCC) to implement the enrollment and multimodal longitudinal assessment of a large cohort of patients with acute pain from a musculoskeletal trauma to identify biosignatures for resilience to and/or the transition from acute to chronic pain.

Invasive surgical procedures provide the unique ability to record and stimulate neurons within precisely localized brain structures in humans. Human studies using invasive technology are often constrained by a limited number of patients and resources available to implement complex experimental protocols and are rarely aggregated in a manner that addresses research questions with appropriate statistical power. Therefore, this RFA seeks applications to assemble diverse, integrated, multi-disciplinary teams that cross boundaries of interdisciplinary collaboration to overcome these fundamental barriers and to investigate high-impact questions in human neuroscience. Projects should maximize opportunities to conduct innovative in vivo neuroscience research made available by direct access to brain recording and stimulating from invasive surgical procedures.

Invasive surgical procedures provide the unique ability to record and stimulate neurons within precisely localized brain structures in humans. Human studies using invasive technology are often constrained by a limited number of patients and resources available to implement complex experimental protocols and are rarely aggregated in a manner that addresses research questions with appropriate statistical power. Therefore, this RFA seeks applications to assemble diverse, integrated, multi-disciplinary teams that cross boundaries of interdisciplinary collaboration to overcome these fundamental barriers and to investigate high-impact questions in human neuroscience. Projects should maximize opportunities to conduct innovative in vivo neuroscience research made available by direct access to brain recording and stimulating from invasive surgical procedures. Projects should employ approaches guided by specified theoretical constructs and quantitative, mechanistic models where appropriate. Awardees will join a consortium work group, coordinated by the NIH, to identify consensus standards of practice, including neuroethical considerations, to collect and provide data for ancillary studies, and to aggregate and standardize data for dissemination among the wider scientific community.

The purpose of this FOA is to identify and support a Clinical Coordination Center (CCC) for the Common Fund Acute to Chronic Pain Signatures (A2CPS) Program. The Clinical Coordinating Center is expected to serve as the hub for the Multisite Clinical Centers (below) to support study design, efficiency, progress, and quality, and to coordinate and monitor study implementation across the clinical sites. The Clinical Coordinating Center will lead the consortium in developing and implementing standardized protocols, safety standards, staff training protocols, electronic health record (EHR) data standards, patient phenotyping and testing, and regulatory processes.

Founded in 1999, the Colorectal Cancer Alliance works to empower a nation of advocates to support patients, raise awareness of preventative measures, and inspire efforts to fund critical research. The alliance is committed to investing $10 million in critical research by 2021, including $3 million specifically to young-onset colorectal cancer research. To advance this goal, the alliance will award three Colorectal Cancer Alliance Chris4Life Research Grants in Young-Onset Colorectal Cancer Research in December 2018 (funding start date January 2019). Grant proposals will be considered in the categories of basic, translational, clinical, or epidemiological. Projects should focus on risk factors and causes associated with the rise in young-onset colorectal cancer, including but not limited to changes in the microbiome and its impact on young-onset colorectal cancer; prevention and early detection strategies for reducing the incidence and death rates associated with young-onset colorectal cancer; better mechanisms for increasing the long-term survival rates of those with young-onset colorectal cancer; and/or the psychosocial impacts of young-onset colorectal cancer and the overall social influence on daily survivorship.

Clinical trials for Alzheimer's disease and related dementias have been hindered, in part, by the limited number of biomarkers available to (1) accurately diagnose these diseases; (2) enrich and stratify patient cohorts; (3) demonstrate target engagement for novel therapeutics; and (4) reliably monitor disease progression and response to treatment. While currently available biomarkers have helped to accelerate clinical trials, most are either expensive, invasive, or both, and only provide information on a small number of disease targets. Therefore, additional biomarkers are needed to provide a more complete picture of the disease.

This Funding Opportunity Announcement (FOA) invites U54 Cooperative Agreement applications aiming to establish multi-component Alzheimer Centers for the Discovery of New Medicines. The overarching purpose of this Centers program is to improve, diversify and reinvigorate the Alzheimers disease (AD) drug development pipeline by accelerating the characterization and experimental validation of next generation therapeutic targets and, integrating the targets into drug discovery campaigns. In addition, this program aims to de-risk potential therapeutics to the point that industry will invest in them, accelerating the delivery of new drugs to AD patients. To this end, the funded Centers will design, develop and disseminate tools that support target enabling packages (TEPs) for the experimental validation of novel, next generation therapeutic targets, including those emanating from the NIA-funded, target discovery programs such as AMP-AD and, initiate early stage drug discovery campaigns against the enabled targets.

This Funding Opportunity Announcement (FOA) invites U54 Cooperative Agreement applications aiming to establish multi-component Alzheimer Centers for the Discovery of New Medicines. The overarching purpose of this Centers program is to improve, diversify and reinvigorate the Alzheimer's disease (AD) drug development pipeline by accelerating the characterization and experimental validation of next generation therapeutic targets and integrating the targets into drug discovery campaigns. In addition, this program aims to de-risk potential therapeutics to the point that industry will invest in them, accelerating the delivery of new drugs to AD patients. To this end, the funded Centers will 1) design, develop and disseminate tools that support target enabling packages (TEPs) for the experimental validation of novel, next generation therapeutic targets, including those emanating from the NIA-funded, target discovery programs such as AMP-AD, and 2) initiate early stage drug discovery campaigns against the enabled targets.  

The purpose of this research project is to use medical and pharmacy claims data in real-time to: 1) identify HIV-infected patients who have stopped filling anti-retroviral (ARV) prescriptions and to target these individuals for adherence and retention intervention(s) (Category A); and 2) identify persons living with HIV (including pregnant women) and to ensure these individuals are receiving ARV therapy - Medical and Pharmacy Claims (Category B).

The FY18 PH/TBIRP CTRR-CTDA mechanism is being offered for the first time in FY18 and is intended to support the development of clinical trials focused on TBI rehabilitation interventions in the FY18 PH/TBIRP CTRR-CTDA focus areas described in II.A.1. Development of clinical trials focusing on rehabilitation strategies in patients with mild TBI is highly encouraged. The proposed research must be relevant to active duty Service members, Veterans, and their beneficiaries. It is expected that any research findings will also provide benefit to the general population. The PH/TBIRP CTRR-CTDA mechanism supports the design and development of the research resources necessary to serve as a foundation for investigator-initiated clinical trials under future PH/TBIRP CTRR-Clinical Trial Award with the potential to develop knowledge and material products for rehabilitation and restoration of function following TBI. Principal Investigators (PIs) should explain how the proposed future clinical trial will inform the development, refinement, and/or revision of existing standards of care, clinical recommendations, or guidelines.

 The purpose of this Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), is to support the Cooperative Human Tissue Network (CHTN). The goal for CHTN is to collect and distribute to investigators high quality human tissue specimens to facilitate basic and early translational cancer research. For example, such specimens may be needed for scientific discovery and the development of various molecular diagnostic tests, prognostic or predictive assays. The CHTN is designed as a unique biospecimen resource in that it is based on prospective collection and distribution of samples upon specific investigators' requests. Samples to be collected from patients include pre-cancerous, cancerous, and benign neoplastic tissues, as well as specimens corresponding to non-neoplastic diseases and uninvolved tissues.

The American Society of Nephrology fights to prevent, treat, and cure kidney diseases by educating health professionals and scientists, advancing research and innovation, communicating new knowledge, and advocating for the highest quality care for patients. As part of this mission, the ASN Foundation is accepting applications for its William and Sandra Bennett Clinical Scholars Program. The goal of the program is to help produce the next generation of clinician educators by enabling applicants to improve their teaching skills through the acquisition of education tools and by supporting aspiring nephrology educators to conduct a project that advances an aspect of nephrology education and teaching.

The purpose of this Funding Opportunity Announcement is to support studies that will evaluate HIV drug resistance and its relationship to treatment success. Applications are sought proposing studies of genotype/phenotype correlations in diverse subtypes, the relationship between drug resistance mutations present in minority variant viral populations and treatment outcomes, and on the reasons for the discordance between genotype and treatment success or failure. Laboratory evaluations of samples with clinical correlates in patients on recommended regimens are encouraged.