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This Notice of Funding Opportunity (NOFO) invites applications for a Research Coordinating Center (RCC) to participate in a consortium of clinical centers that will test anti-obesity medication (AOM) treatment strategies for youth with obesity that maximize benefits and minimize risks of AOM use. Such intervention strategies should support the promotion of healthy growth and development; adequate nutritional status/intake, healthy eating and physical activity behaviors; mental health and well-being (e.g., body image, self-esteem, mood, etc.), and quality of life and be feasible to implement in clinical care settings. Priority areas include testing strategies to determine optimal developmental stage for AOM initiation, rate and amount of weight loss, AOM class, dose, frequency, and duration, and content and intensity of adjunct lifestyle therapies that may be imperative to ensure normal psychological and physical development and to potentially avoid lifelong dependence on AOMs. Investigators should also evaluate potential predictors of response/ nonresponse to various treatment strategies under evaluation. The clinical centers may conduct independent or multicenter trials but will collaborate on the development of protocols, use of common measures and data elements, use of a central laboratory and standardized procedures to collect data and biospecimens, and data analyses and manuscriptsThe RCC will lead, manage, and harmonize efforts for the Consortium including 1) providing management and administrative support; 2) providing leadership and expertise on statistical design a...

This Notice of Funding Opportunity (NOFO) invites applications from clinical centers to participate in a consortium to test anti-obesity medication (AOM) treatment strategies for youth with obesity that maximize benefits and minimize risks of AOM use. Such intervention strategies should support the promotion of healthy growth and development; adequate nutritional status/intake, healthy eating and physical activity behaviors; mental health and well-being (e.g., body image, self-esteem, mood, etc.), and quality of life and be feasible to implement in clinical care settings. Priority areas include testing strategies to determine optimal developmental stage for AOM initiation, rate and amount of weight loss, AOM class, dose, frequency, and duration, and content and intensity of adjunct lifestyle therapies that may be imperative to ensure normal psychological and physical development and to potentially avoid lifelong dependence on AOMs. Investigators should also evaluate potential predictors of response/ nonresponse to various treatment strategies under evaluation. The clinical centers may conduct independent or multicenter trials but will collaborate on the development of protocols, use of common measures and data elements, use of a central laboratory and standardized procedures to collect data and biospecimens, and data analyses and manuscripts. This NOFO uses a cooperative agreement mechanism (U01) and runs in parallel with a companion NOFO (RFA-DK-27-136).

The overarching goal of this notice of funding opportunity (NOFO) and its companion opportunities is to establish the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program to support development of innovative, reliable, cost-effective, and sustainable multimodal AI-based clinical decision support (CDS) tools. PRIMED-AI CDS tools are based on the integration of clinical imaging with other types of multimodal health data to enhance care for patients with a wide range of health conditions. The PRIMED-AI Program seeks to catalyze the adoption of AI-based CDS tools into clinical workflows to enable novel personalized medicine strategies that address significant health challenges. The purpose of this NOFO is to solicit applications for the design, development, and preliminary validation of robust frameworks for the application of multimodal-artificial intelligence (AI) models for clinical use. Frameworks developed through these awards would populate a "playbook", defined as a collection of actionable guidelines, standardized protocols, and/or standard operating procedures (SOPs) for reliable and effective development and deployment of multimodal AI tools. It is expected that the frameworks delineated in this playbook will directly address PRIMED-AI objectives and needs, while also remaining flexible enough to enable sufficient extensibility and interoperability for use across a broad spectrum of multimodal biomedical AI applications, both internal and external to the PRIMED-AI Program.

The purpose of this notice of funding opportunity (NOFO) is to elucidate the key components of the therapeutic effects of rapid-acting psychotropic interventional drugs (RAPIDs) by addressing the methodological challenges involved with these clinical trials. In addition, this NOFO seeks to advance understanding of how RAPIDs and adjunctive psychosocial interventions can be optimally delivered, monitored, and sustained over time to enhance effectiveness and generalizability. The NOFO will support studies designed to enhance the rigor of RAPID clinical trial design, which will ultimately increase the interpretability of the data and the generalizability of the results.

The purpose of the NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00) program is to increase and maintain a strong cohort of new and talented, NCI-supported, independent investigators. This program is designed for postdoctoral fellows with research and/or clinical doctoral degrees who do not require an extended period of mentored research training beyond their doctoral degrees. The objective of this award is to facilitate a timely transition of these fellows from their mentored, postdoctoral research positions to independent tenure-track (or equivalent) faculty positions. The program will provide independent NCI research support during this transition to help awardees to launch competitive, independent research careers. Researchers in the scientific areas of cancer control, cancer prevention and cancer data sciences are especially encouraged to work with their institutions to apply. This notice of funding opportunity (NOFO) is designed specifically for candidates proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development. Those not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to the 'Independent Clinical Trial Not Allowed' companion NOFO (PAR-23-286).

The purpose of the NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00) program is to increase and maintain a strong cohort of new and talented, NCI-supported, independent investigators. This program is designed for postdoctoral fellows with research and/or clinical doctoral degrees who do not require an extended period of mentored research training beyond their doctoral degrees. The objective of this award is to facilitate a timely transition of these fellows from their mentored, postdoctoral research positions to independent tenure-track (or equivalent) faculty positions. The program will provide independent NCI research support during this transition to help awardees to launch competitive, independent research careers. Researchers in the scientific areas of cancer control, cancer prevention and cancer data sciences are especially encouraged to work with their institutions to apply. This Notice of Funding Opportunity (NOFO) is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Under this NOFO candidates are permitted to propose a research experience in a clinical trial led by a mentor or co-mentor. Those proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion NOFOs (PAR-23-287 or PAR-23-288).

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to accelerate the adoption and validation of molecular/cellular/imaging markers (referred to as "markers" or "biomarkers") and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants to this NOFO must have an assay(s) whose performance has been analytically validated in specimens similar to those for the intended clinical use of the marker(s) and assay(s). As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance the durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. The UH3 mechanism will support the clinical validation of established assays for up to 3 years using specimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this NOFO will require multi-disciplinary interaction and collaboration among scientific investigators, oncologists, statisticians, and cli...

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications to support the validation of molecular/cellular/imaging markers (referred to as "markers" or "biomarkers") and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This FOA will support investigator-initiated research for both analytical, and clinical validation of assays to be used in cancer treatment, control, or prevention trials supported by the NCI. This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants should have assays that work on human samples and whose importance is well justified for development into clinical assays. As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance the durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. The UH2 phase of this NOFO supports analytical validation of assays for these molecular/cellular/imaging markers, which must be achieved within 2 years before assays may undergo clinical validation. The UH3 phase of this NOFO supports clinical validation of analytically validated assays for up to 3 years using well-annotated biospecimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other cancer clinical trials, observational studies, or population s...

Through this Notice of Funding Opportunity (NOFO) is to accelerate the pace of translation of NCI-supported methods/assays/technologies (referred to as "assays") to the clinic. Specifically, the focus of this NOFO is on the adaption and clinical validation of molecular/cellular/imaging markers (referred to as "markers" r "biomarkers") for cancer detection, diagnosis, prognosis, monitoring, and prediction of response in treatment, as well as markers for cancer control and prevention. Research applications may support the acquisition of well-annotated specimens from NCI-supported or other clinical trials or observational cohorts/consortia for the purpose of clinical validation of the assay. Research projects proposed for this NOFO encourage multi-disciplinary interaction among scientific investigators, assay developers, clinicians, statisticians, and clinical laboratory staff. Clinical laboratory scientist(s) and statistical experts are highly encouraged to comprise integral parts of the application. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials, but rather the adaption and validation of assays to the point where they could be integrated into clinical trials as investigational assays/tools/devices.

The goal of this NOFO is to support doctoral candidates studying high-priority areas of child health for the completion of their doctoral dissertation research project. This NOFO seeks to advance research in child health by stimulating the use of Environmental Influences on Child Health (ECHO) Cohort data by doctoral students in relevant scientific areas. This RFA will provide students working on dissertations the opportunity to access the ECHO data within the NICHD Data and Specimen Hub (DASH) repository. ECHO"s DASH dataset integrates de-identified longitudinal data from more than 71,000 participants across the U.S. Prenatal and child exposure data include physical, chemical, social, behavioral, and biological factors. ECHO"s five primary pediatric outcome areas are pre-, peri-, and postnatal outcomes, upper and lower airway, obesity, neurodevelopment, and positive health. This award will facilitate the entry of promising new investigators into the field of early environmental exposures and child health research, enhancing the pool of highly talented researchers.

The purpose of this notice of funding opportunity (NOFO) is to foster research that will inform and support the optimization, delivery, sustainability, and effectiveness of empirically-supported practices for addressing the mental health needs of older adults with serious mental illness (SMI). To this end, NIMH seeks applications that propose work that is focused on practice-relevant questions and conducted within and/or across settings where older adults with SMI are likely to be identified as needing care (e.g., primary care and geriatric specialty clinics, assisted living and long-term care facilities, and community centers). Applications may propose research related to adapting, optimizing, and implementing efficacious treatment and services interventions and strategies to improve clinical and functional outcomes among aging populations; examining mutable factors that impact fair and impartial mental health care access, utilization, quality, and outcomes and may serve as targets for intervention development for older adults with SMI; and developing and testing innovative treatment and service interventions that address barriers to accessing quality mental health care. Projects may also focus on systems-level factors and approaches for addressing SMI and improving access to evidence-based interventions in later life, such as evaluation of health system policies and practices, interventions that facilitate care transitions and continuity across settings, and strategies to improve care linkages and coordination across systems.

This announcement invites applications for basic research projects on chemical warfare agents, toxic industrial chemicals, and pesticides that have primary or secondary effects on the nervous system. Chemical threats are toxic compounds that could be used in a terrorist attack or accidentally released from industrial production, storage, or shipping. Projects supported by this NOFO are expected to generate data that elucidate mechanisms of toxicity of these agents, possible new manifestations of toxic exposures, and potential new targets for therapeutic development.

The purpose of this NOFO is to enhance the capability of NCATS CTSA Program KL2 scholars and recipients of re-entry supplements supported by the CTSA Program to conduct research as they complete the transition to fully independent academic translational scientists. These R03 grants will support different clinical and translational science research projects, including pilot and feasibility studies; secondary data analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. Research proposed in the R03 application may or may not include patient-oriented research. The R03 is, therefore, intended to support research projects that can be carried out in a short period of time with limited resources and that provide preliminary data to support submission of a subsequent R01, or equivalent, application.

The purpose of this Notice of Funding Opportunity (NOFO) is to seek applications for a Community Engagement Evaluation and Data coordination hub (CEED) for the Community-Based Participatory Research (CBPR) consortium: Advancing Data and Practice Transformation (ADAPT) for Optimizing Oral Health for All. In addition to CEED, the ADAPT consortium will include separately funded CBPR projects, which will receive consultative services from the NIH Community Engagement Alliance Consultative Resource (CEACR) and join in the Science Collaborative for Health and Artificial Intelligence Reduction of Errors (SCHARE) platform for the overarching goal of promoting data use and transformational community engagement to optimize oral health for all people. The CEED hub will coordinate communications and various activities in support of CBPR projects and consortium functions in three domains:1) Data Planning, Consultation, and Technical Assistance for Research Methodology and Analytics; 2) Community Engagement Evaluation; and 3) ADAPT Infrastructure and Operational Support.

This Notice of Funding Opportunity (NOFO) solicits applications for the continued development and sustainment of high value informatics research resources to improve the acquisition, management, analysis, and dissemination of data and knowledge across the cancer research continuum including cancer biology, cancer treatment and diagnosis, early cancer detection, risk assessment and prevention, cancer control and epidemiology. As a component of the NCI's Informatics Technology for Cancer Research (ITCR) Program, this NOFO is focused on sustaining operations and maintaining and evolving the scientific relevance of existing, widely-adopted informatics tools and resources. This is in contrast to early-stage and advanced development efforts to generate these tools and resources that will be supported by companion ITCR NOFOs. The central mission of ITCR is to promote research-driven informatics technology across the development lifecycle to address priority needs in cancer research. In order to be successful, the application must provide clear justification for why the research resource should be maintained and how it has benefited and will continue to benefit the cancer research field. In addition, mechanisms for assessing and maximizing the value of the resource to researchers and supporting close engagement between the resource and the targeted research community should be described.This NOFO invites applications to support the sustained operations of informatics technology resources that support a wide range of cancer research, including discovery biology, population studies,....

This Notice of Funding Opportunity (NOFO) invites applications for advanced development and enhancement of emerging informatics technologies to improve the acquisition, analysis, visualization, and interpretation of data across the cancer research continuum including cancer biology, cancer treatment and diagnosis, early cancer detection, risk assessment and prevention, cancer control and epidemiology. As a component of the NCI's Informatics Technology for Cancer Research (ITCR) Program, this NOFO is focused on advancing emerging informatics technology, defined as one that has passed the initial prototyping and pilot development stage, has demonstrated potential to have a significant and broader impact, has compelling reasons for further improvement and enhancement, and has not been widely adopted in the cancer research field. To be successful, proposed development plans must have a clear rationale for why the proposed technology is needed and how it will benefit the cancer research field. In addition, mechanisms to solicit feedback from driving cancer research projects as well as the broader user community throughout the development process must be included.This NOFO invites applications for the enhancement and dissemination of emerging, user-friendly informatics technologies that support a wide range of cancer research, including discovery biology, population studies, as well as clinical and translational research. The emphasis is on uniqueness and potential impact on cancer research. In addition, all projects proposed in response to this NOFO must involve the following ge...

The overarching goal of this notice of funding opportunity (NOFO) and its companion opportunities is to establish the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program to support development of innovative, reliable, cost-effective, and sustainable multimodal AI-based clinical decision support (CDS) tools. PRIMED-AI CDS tools are based on the integration of clinical imaging with other types of multimodal health data to enhance care for patients with a wide range of health conditions. The PRIMED-AI Program seeks to catalyze the adoption of AI-based CDS tools into clinical workflows to enable novel personalized medicine strategies that address significant health challenges.The purpose of this NOFO is to catalyze the translation of Artificial Intelligence (AI)-enabled, image-centered, multimodal CDS tools, developed as Software as a Medical Device, from training and testing of prototypes towards clinical applications that address unmet health challenges in precision medicine. These projects are expected to have high potential for demonstrable, positive impact on patient outcomes and/or healthcare processes.

The overarching goal of this notice of funding opportunity (NOFO) and its companion opportunities is to establish the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program to support development of innovative, reliable, cost-effective, and sustainable multimodal AI-based clinical decision support (CDS) tools. PRIMED-AI CDS tools are based on the integration of clinical imaging with other types of multimodal health data to enhance care for patients with a wide range of health conditions. The PRIMED-AI Program seeks to catalyze the adoption of AI-based CDS tools into clinical workflows to enable novel personalized medicine strategies that address significant health challenges. The purpose of this Notice of Funding Opportunity (NOFO) is to catalyze the development and testing of Artificial Intelligence (AI)-enabled, image-centered, multimodal Clinical Decision Support (CDS) tools, developed in pursuance as Software as a Medical Device (SaMD). These projects are expected to have high potential for demonstrable, positive impact on patient outcomes and/or healthcare processes.

This Notice of Funding Opportunity (NOFO) invites applications from institutions/organizations that propose to establish core centers that are part of an integrated and existing program of nutrition and/or obesity research. The Nutrition Obesity Research Centers (NORC) program is designed to support and enhance the national research effort in nutrition and obesity. NORCs support three primary research-related activities: Research Core services, a Pilot and Feasibility (P and F) program, and a Scientific Catalyst program. All activities pursued by Nutrition Obesity Research Centers are designed to enhance the efficiency, productivity, effectiveness, and multidisciplinary nature of research in nutrition and obesity.

NIMH seeks applications for pilot research to adapt, optimize, and test behavioral interventions that address common sleep problems in adolescents and young adults with or at risk for a mental health disorder. This notice of funding opportunity (NOFO) supports pilot clinical trials designed to evaluate the feasibility, tolerability, acceptability, safety, and potential effectiveness of the approach in real world settings. Applications should aim to conduct a preliminary test of the intervention's impact on sleep and mental health outcomes, as well as an examination of the mechanisms that underlie the intervention's effectiveness, and to obtain preliminary data needed as a prerequisite for larger-scale effectiveness trials. In addition, interdisciplinary, collaborative teams of investigators from the fields of mental health, sleep medicine, developmental science, clinical trials research methods, behavioral economics, implementation science, data science, and human computer interaction are encouraged.

The Population Assessment of Tobacco and Health (PATH) Study provides the scientific community with biospecimens (urine, plasma, serum, and genomic DNA) and related research data on behaviors, attitudes, biomarkers and health outcomes associated with tobacco use in the U.S. This opportunity allows investigators to apply for access to the biospecimens from the PATH Study. Information about the PATH Study and this resource may be found on the PATH Study series page (https://doi.org/10.3886/Series606) at the University of Michigans National Addiction and HIV Data Archive Program (NAHDAP) website, part of the Inter-University Consortium for Political and Social Researchs (ICPSR) website.

The Genomics Research to Elucidate the Genetics of Rare Diseases:innovation (GREGoRi) initiative seeks to accelerate a paradigm shift in rare disease diagnosis by reimagining the tools, molecular technologies and analytical approaches used to identify the causal gene(s) and/or variant(s) underlying rare genetic disorders. This Notice of Funding Opportunity is intended to stimulate the development and testing of highly innovative experimental or computational approaches for rare disease diagnosis, that have the potential to make transformative improvements to the current state of the art.

The Genomics Research to Elucidate the Genetics of Rare Diseases:innovation (GREGoRi) initiative seeks to accelerate a paradigm shift in rare disease diagnosis by reimagining the tools, molecular technologies and analytical approaches used to identify the causal gene(s) and/or variant(s) underlying rare genetic disorders. The purpose of this Notice of Funding Opportunity is to establish the GREGoRi Data Coordination and Outreach Center. The Data Coordination and Outreach Center will act as the central point of coordination for the GREGoRi Research Program, and will be responsible for ensuring that the protocols, data, metadata, computational tools and other resources developed as part of GREGoRi are made available to the broader research community.

The Genomics Research to Elucidate the Genetics of Rare Diseases:innovation (GREGoRi) initiative seeks to accelerate a paradigm shift in rare disease diagnosis by reimagining the tools, molecular technologies and analytical approaches used to identify the causal gene(s) and/or variant(s) underlying rare genetic disorders. The purpose of this Notice of Funding Opportunity is to establish the GREGoRi Technology Integration Center, which will enable the development of standards and best practices for applying new and emerging molecular methods in rare disease diagnosis. A major deliverable of the Center will be a multidimensional dataset that can be used for the development and benchmarking of novel tools and strategies that facilitate rare disease diagnosis.

This Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed) PAR, was re-issued as a result of the Simplifying Review of Research Project Grant Applications [link: https://grants.nih.gov/policy-and-compliance/policy-topics/peer-review/simplifying-review]. The Simplified Review changes in Section V are the only changes that have been made. All other aspects of this funding opportunity remain the same.