Represents Grant table in the DB

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    "data": [
        {
            "type": "Grant",
            "id": "12279",
            "attributes": {
                "award_id": "1C06OD036014-01",
                "title": "Biomaterial Manufacturing Suite in Support of NIH/NIAID and the Global Infectious Disease Research Community",
                "funder": {
                    "id": 4,
                    "ror": "https://ror.org/01cwqze88",
                    "name": "National Institutes of Health",
                    "approved": true
                },
                "funder_divisions": [
                    "NIH Office of the Director"
                ],
                "program_reference_codes": [],
                "program_officials": [
                    {
                        "id": 28173,
                        "first_name": "YONG",
                        "last_name": "Chen",
                        "orcid": null,
                        "emails": "",
                        "private_emails": "",
                        "keywords": null,
                        "approved": true,
                        "websites": null,
                        "desired_collaboration": null,
                        "comments": null,
                        "affiliations": []
                    }
                ],
                "start_date": "2023-09-06",
                "end_date": "2026-11-30",
                "award_amount": 4798286,
                "principal_investigator": {
                    "id": 26529,
                    "first_name": "Rebecca",
                    "last_name": "Bradford",
                    "orcid": null,
                    "emails": "",
                    "private_emails": "",
                    "keywords": null,
                    "approved": true,
                    "websites": null,
                    "desired_collaboration": null,
                    "comments": null,
                    "affiliations": []
                },
                "other_investigators": [],
                "awardee_organization": {
                    "id": 1788,
                    "ror": "https://ror.org/03thhhv76",
                    "name": "American Type Culture Collection",
                    "address": "",
                    "city": "",
                    "state": "VA",
                    "zip": "",
                    "country": "United States",
                    "approved": true
                },
                "abstract": "Biomaterial Manufacturing Suite in Support of NIH/NIAID and the Global Infectious  Disease Research Community  PROJECT DIRECTOR: REBECCA BRADFORD, MBA, MS, PMP® Project Summary The project is to construct and commission a Biomaterial Manufacturing Suite (BMS) as an expansion within the High Containment Facility (HCF) currently under design at the American Type Culture Collection (ATCC). ATCC is a non-profit entity in Manassas, Virginia, serving the Federal Government for over 50 years through our Federal Solutions (AFS) Division. The proposed aim of the BMS is to provide modern and reproducible large-scale biomaterial manufacturing capabilities for priority pathogens. Residing within the soon-to-be-built HCF, the BMS will offer the National Institute of Health and the National Institute of Allergy and Infectious Diseases (NIH/NIAID) high-throughput and rapid development pipelines for biomaterials of public health concern, including those of epidemic or pandemic potential. The BMS will directly support Federal Agencies and the infectious disease research communities by optimizing pathogenic organisms’ growth, production, and characterization for downstream use. By funding the BMS within the planned facility, AFS can enhance our support to NIH/NIAID through our ability to offer large-scale stocks of well-characterized challenge materials at no cost to the research community through AFS managed programs, including BEI Resources. In turn, this will accelerate infectious disease research for vaccine and therapeutic development in outbreak situations and serve as biological standards for developing detection assays. AFS’ current modular 7,500 ft2 HCF was built in 2007 as a temporary solution to facilitate the expanding needs of AFS’ Health and Human Services (HHS) programs. The facility is now over- extended with respect to lifespan, capacity, and capabilities. AFS dutifully maintains the upkeep of the current HCF to support the extensive NIH/NIAID requests for biological products to advance our medical countermeasures and arsenal against variants for the recent onslaught of the COVID- 19 pandemic. As a non-profit organization, ATCC has committed several million dollars to design and construct a new HCF to enhance and modernize our support to NIH. The explicit goal of this funding is to include the design, construction, and commissioning of the BMS within the facility footprint to provide critical biological manufacturing capabilities in the biomedical space to accelerate translational research for vaccine and therapeutic development.",
                "keywords": [
                    "Acceleration",
                    "American Type Culture Collection",
                    "Biocompatible Materials",
                    "Biological",
                    "Biological Products",
                    "COVID-19 pandemic",
                    "Communities",
                    "Containment",
                    "Development",
                    "Disease Outbreaks",
                    "Federal Government",
                    "Funding",
                    "Goals",
                    "Growth",
                    "Health",
                    "Human",
                    "Infectious Diseases Research",
                    "Longevity",
                    "Modernization",
                    "National Institute of Allergy and Infectious Disease",
                    "Nonprofit Organizations",
                    "Organism",
                    "Pathogenicity",
                    "Production",
                    "Public Health",
                    "Reproducibility",
                    "Research",
                    "Resources",
                    "Translational Research",
                    "United States National Institutes of Health",
                    "Variant",
                    "Virginia",
                    "cost",
                    "design",
                    "design and construction",
                    "detection assay",
                    "epidemic potential",
                    "manufacture",
                    "manufacturing capabilities",
                    "medical countermeasure",
                    "pandemic potential",
                    "priority pathogen",
                    "programs",
                    "service programs",
                    "therapeutic development",
                    "vaccine development"
                ],
                "approved": true
            }
        },
        {
            "type": "Grant",
            "id": "12280",
            "attributes": {
                "award_id": "1R01DA059415-01",
                "title": "Integrating eye-tracking and ECG methodologies for remote infant neurocognitive assessments in the home",
                "funder": {
                    "id": 4,
                    "ror": "https://ror.org/01cwqze88",
                    "name": "National Institutes of Health",
                    "approved": true
                },
                "funder_divisions": [
                    "National Institute on Drug Abuse (NIDA)"
                ],
                "program_reference_codes": [],
                "program_officials": [
                    {
                        "id": 28174,
                        "first_name": "JOHN RAPHAEL",
                        "last_name": "Fedota",
                        "orcid": null,
                        "emails": "",
                        "private_emails": "",
                        "keywords": null,
                        "approved": true,
                        "websites": null,
                        "desired_collaboration": null,
                        "comments": null,
                        "affiliations": []
                    }
                ],
                "start_date": "2023-09-30",
                "end_date": "2027-07-31",
                "award_amount": 597896,
                "principal_investigator": {
                    "id": 22463,
                    "first_name": "Natalie Hiromi",
                    "last_name": "Brito",
                    "orcid": null,
                    "emails": "",
                    "private_emails": "",
                    "keywords": null,
                    "approved": true,
                    "websites": null,
                    "desired_collaboration": null,
                    "comments": null,
                    "affiliations": [
                        {
                            "id": 167,
                            "ror": "https://ror.org/0190ak572",
                            "name": "New York University",
                            "address": "",
                            "city": "",
                            "state": "NY",
                            "zip": "",
                            "country": "United States",
                            "approved": true
                        }
                    ]
                },
                "other_investigators": [],
                "awardee_organization": {
                    "id": 167,
                    "ror": "https://ror.org/0190ak572",
                    "name": "New York University",
                    "address": "",
                    "city": "",
                    "state": "NY",
                    "zip": "",
                    "country": "United States",
                    "approved": true
                },
                "abstract": "Use of remote data collection methodology in developmental research has increased significantly, in part due to in-person data collection stoppage that occurred at the start of the COVID-19 pandemic. These kinds of data collection methods are likely to decrease barriers to participation for families, increase sample sociodemographic diversity, and could potentially address common problems in the field related to statistical power and sampling bias, all significant issues associated with construct and ecological validity. The central objective of this proposal is to support the rigorous application and validation of remote infant testing methodology of early cognitive development when infants are 4, 8, and 12-month of age. We will recruit 300 families who are traditionally underrepresented in developmental neuroscience research to participate in this longitudinal study. The primary aims of this project are to (i) establish and validate remote physiological and behavioral measurements of infant attention and memory skills, (ii) investigate the impact of caregiver-infant physiological co-regulation on infant outcomes, and (iii) evaluate predictors of infant attention phenotypes and longitudinal associations with socioemotional outcomes and autism risk. This proposal integrates multi-level data to improve measurement of infant cognition within the home and will substantially enrich our understanding of developmental trajectories and mechanisms across socio-demographically diverse environments and contexts, leading to increased precision for prevention and intervention efforts.",
                "keywords": [
                    "Address",
                    "Affect",
                    "Age Months",
                    "Area",
                    "Arousal",
                    "Attention",
                    "Back",
                    "Behavior",
                    "Behavioral",
                    "COVID-19 pandemic",
                    "Caregivers",
                    "Characteristics",
                    "Child Development",
                    "Childhood",
                    "Cognition",
                    "Cognitive",
                    "Complex",
                    "Computers",
                    "Data",
                    "Data Collection",
                    "Development",
                    "Electrocardiogram",
                    "Emotional",
                    "Environment",
                    "Eye",
                    "Family",
                    "Heart Rate",
                    "Home",
                    "Home environment",
                    "Household",
                    "Infant",
                    "Intervention",
                    "Laboratories",
                    "Life",
                    "Link",
                    "Longitudinal Studies",
                    "Low income",
                    "Machine Learning",
                    "Measures",
                    "Memory",
                    "Methodology",
                    "Methods",
                    "Modality",
                    "Neurocognitive",
                    "Neurodevelopmental Disorder",
                    "Neurosciences Research",
                    "Outcome",
                    "Participant",
                    "Persons",
                    "Phenotype",
                    "Physiological",
                    "Physiology",
                    "Play",
                    "Process",
                    "Protocols documentation",
                    "Psychosocial Stress",
                    "Race",
                    "Regulation",
                    "Reproducibility",
                    "Research",
                    "Research Methodology",
                    "Response to stimulus physiology",
                    "Risk",
                    "Risk Marker",
                    "Role",
                    "Sampling",
                    "Sampling Biases",
                    "Short-Term Memory",
                    "Testing",
                    "Validation",
                    "Visual attention",
                    "autism spectrum disorder",
                    "behavior measurement",
                    "cognitive development",
                    "cognitive skill",
                    "cognitive testing",
                    "data collection methodology",
                    "ethnic diversity",
                    "family burden",
                    "gaze",
                    "handheld mobile device",
                    "improved",
                    "indexing",
                    "individualized prevention",
                    "infant monitoring",
                    "infant outcome",
                    "marginalized community",
                    "memory recognition",
                    "multimodality",
                    "non-verbal",
                    "open source",
                    "procedural memory",
                    "recruit",
                    "remote assessment",
                    "remote grading",
                    "rural residence",
                    "skills",
                    "sociodemographics",
                    "socioeconomics",
                    "sustained attention",
                    "visual tracking"
                ],
                "approved": true
            }
        },
        {
            "type": "Grant",
            "id": "12281",
            "attributes": {
                "award_id": "1R13HL172622-01",
                "title": "25th International Workshop on Long-term Complications of HIV and SARS-CoV-2",
                "funder": {
                    "id": 4,
                    "ror": "https://ror.org/01cwqze88",
                    "name": "National Institutes of Health",
                    "approved": true
                },
                "funder_divisions": [
                    "National Institute of Allergy and Infectious Diseases (NIAID)",
                    "National Heart Lung and Blood Institute (NHLBI)"
                ],
                "program_reference_codes": [],
                "program_officials": [
                    {
                        "id": 28175,
                        "first_name": "ROY L",
                        "last_name": "Sutliff",
                        "orcid": null,
                        "emails": "",
                        "private_emails": "",
                        "keywords": null,
                        "approved": true,
                        "websites": null,
                        "desired_collaboration": null,
                        "comments": null,
                        "affiliations": []
                    }
                ],
                "start_date": "2023-09-16",
                "end_date": "2024-08-31",
                "award_amount": 68333,
                "principal_investigator": {
                    "id": 12248,
                    "first_name": "TODD T",
                    "last_name": "BROWN",
                    "orcid": null,
                    "emails": "",
                    "private_emails": "",
                    "keywords": null,
                    "approved": true,
                    "websites": null,
                    "desired_collaboration": null,
                    "comments": null,
                    "affiliations": [
                        {
                            "id": 344,
                            "ror": "https://ror.org/00za53h95",
                            "name": "Johns Hopkins University",
                            "address": "",
                            "city": "",
                            "state": "MD",
                            "zip": "",
                            "country": "United States",
                            "approved": true
                        }
                    ]
                },
                "other_investigators": [],
                "awardee_organization": {
                    "id": 344,
                    "ror": "https://ror.org/00za53h95",
                    "name": "Johns Hopkins University",
                    "address": "",
                    "city": "",
                    "state": "MD",
                    "zip": "",
                    "country": "United States",
                    "approved": true
                },
                "abstract": "With the success of antiretroviral therapy (ART), comorbid diseases are now the leading causes of death and disability in people living with HIV around the globe, including in low- and middle- income countries (LMIC). Large meetings are important venues for scientific exchange regarding the latest advances in HIV Comorbidity research, but smaller, more intimate formats that emphasize discussion and networking are critical to the career development of HIV Comorbidity investigators. In addition, there is a need for a forum for scientific exchange regarding post-acute sequelae of COVID-19 (PASC), a poorly understood syndrome which may share pathogenic features with HIV comorbidities and, as a result, has attracted the interest of many HIV Comorbidity researchers. Our workshop, now in its 25th year and renamed the International Workshop on Long-term Complications of HIV and SARS-CoV-2, provides <200 international delegates with an opportunity to come together to discuss the latest findings and controversies in HIV Comorbidity and PASC research in a one-room, two-day format. Plenary speakers are either noted experts from outside of HIV research or HIV researchers with expertise in a specific comorbidity. A highly interactive PASC roundtable, with 2 mini-talks, highlights critical and emerging issues in the pathogenesis and management of PASC. Abstract presentations including 24 15-minute talks and a poster session provide ample opportunity for researchers to present and get feedback on their latest work. With this R13, we propose to enhance the 25th Workshop (December 14th/15th at the NIH in Rockville, MD) with the following aims: 1) to provide a forum for the latest HIV Comorbidity research in LMIC by offering travel scholarships to LMIC investigators, supporting an internationally recognized expert in non-communicable diseases in LMIC as a plenary speaker, and liaising with international training programs, 2) to provide a continued and expanded forum for discussion and dissemination of the latest research findings regarding PASC, 3) to support early-stage HIV Comorbidity and PASC investigators with a highly innovative day-long Career Development Studio prior to the Workshop (December 13th). By providing a “scientific home” to HIV Comorbidity and PASC investigators from around the world, we hope to catalyze future research efforts in HIV Comorbidities and PASC and facilitate the translation of research findings into clinical strategies that can improve the lifespan and healthspan of PLWH and those with long COVID.",
                "keywords": [
                    "2019-nCoV",
                    "Acute",
                    "Adverse effects",
                    "Affect",
                    "Age",
                    "COVID-19",
                    "COVID-19 pandemic",
                    "Cardiovascular Diseases",
                    "Cause of Death",
                    "Chronic",
                    "Chronic Disease",
                    "Clinical",
                    "Collaborations",
                    "Communities",
                    "Discipline",
                    "Disease",
                    "Educational workshop",
                    "Etiology",
                    "Europe",
                    "Feedback",
                    "Fostering",
                    "Funding Opportunities",
                    "Goals",
                    "Grant",
                    "HIV",
                    "HIV Infections",
                    "Home",
                    "Inflammation",
                    "International",
                    "Learning",
                    "Liver diseases",
                    "Long COVID",
                    "Longevity",
                    "Malignant Neoplasms",
                    "Maryland",
                    "NIH Office of AIDS Research",
                    "Names",
                    "National Institute of Allergy and Infectious Disease",
                    "Oral",
                    "Pathogenesis",
                    "Pathogenicity",
                    "Patients",
                    "Persons",
                    "Physiological",
                    "Play",
                    "Post-Acute Sequelae of SARS-CoV-2 Infection",
                    "Research",
                    "Research Personnel",
                    "Resources",
                    "Risk Factors",
                    "Role",
                    "Schedule",
                    "Scholarship",
                    "Science",
                    "Symptoms",
                    "Syndrome",
                    "System",
                    "Training Programs",
                    "Translational Research",
                    "Travel",
                    "United States National Institutes of Health",
                    "Work",
                    "Writing",
                    "acute infection",
                    "antiretroviral therapy",
                    "career development",
                    "clinical practice",
                    "comorbidity",
                    "coronavirus disease",
                    "design",
                    "disability",
                    "healthspan",
                    "improved",
                    "innovation",
                    "interest",
                    "low and middle-income countries",
                    "meetings",
                    "multidisciplinary",
                    "peer",
                    "persistent symptom",
                    "posters",
                    "programs",
                    "skills",
                    "success",
                    "virtual"
                ],
                "approved": true
            }
        },
        {
            "type": "Grant",
            "id": "12282",
            "attributes": {
                "award_id": "1R35GM151249-01",
                "title": "Understanding the OAS/RNase L pathway during pathogenic viral infections",
                "funder": {
                    "id": 4,
                    "ror": "https://ror.org/01cwqze88",
                    "name": "National Institutes of Health",
                    "approved": true
                },
                "funder_divisions": [
                    "National Institute of General Medical Sciences (NIGMS)"
                ],
                "program_reference_codes": [],
                "program_officials": [
                    {
                        "id": 22244,
                        "first_name": "MICHAEL",
                        "last_name": "SAKALIAN",
                        "orcid": null,
                        "emails": "",
                        "private_emails": "",
                        "keywords": null,
                        "approved": true,
                        "websites": null,
                        "desired_collaboration": null,
                        "comments": null,
                        "affiliations": []
                    }
                ],
                "start_date": "2023-09-15",
                "end_date": "2028-07-31",
                "award_amount": 483000,
                "principal_investigator": {
                    "id": 28176,
                    "first_name": "James M",
                    "last_name": "Burke",
                    "orcid": null,
                    "emails": "",
                    "private_emails": "",
                    "keywords": null,
                    "approved": true,
                    "websites": null,
                    "desired_collaboration": null,
                    "comments": null,
                    "affiliations": []
                },
                "other_investigators": [],
                "awardee_organization": {
                    "id": 158,
                    "ror": "https://ror.org/02y3ad647",
                    "name": "University of Florida",
                    "address": "",
                    "city": "",
                    "state": "FL",
                    "zip": "",
                    "country": "United States",
                    "approved": true
                },
                "abstract": "Ribonuclease L (RNase L) is a key component of the mammalian innate antiviral response. For decades, RNase L was presumed to reduce viral protein synthesis by cleaving ribosomes to arrest translation. However, we and others recently demonstrated that RNase L-cleaved ribosomes are translation-competent, and that pathogenic viruses can synthesize proteins despite activating RNase L. These observations have revealed a significant gap in knowledge regarding how RNase L functions and how viruses evade it. We have demonstrated that RNase L rapidly degrades nearly all cellular mRNAs upon activation. This activity regulates three cellular processes that have expanded our understanding of RNase L and that have elucidated how pathogenic viruses evade and potentially hijack RNase L functions. First, RNase L reprograms translation to an antiviral state by degrading constitutively expressed cellular mRNAs while sparing host mRNAs encoding antiviral proteins (e.g., type I interferons), which permits antiviral protein synthesis. Importantly, the mRNAs encoded by several pathogenic viruses (e.g., dengue virus) similarly evade RNase L-mediated mRNA decay, thus permitting viral protein synthesis. This observation has elucidated how pathogenic viruses synthesize proteins despite activating RNase L. This application proposes to characterize the RNase L-mediated mRNA decay pathway and determine how host and viral mRNAs evade it. Second, RNase L activation triggers the inhibition of nuclear mRNA export. This is a critical antiviral mechanism that antagonizes influenza A virus protein synthesis, but it also downregulates the expression of host antiviral proteins (e.g., type I interferons). Importantly, pathogenic viruses (e.g., dengue virus) activate this RNase L-dependent pathway, resulting in sequestration of host antiviral mRNAs in the nucleus. This observation suggests that viruses potentially hijack this function of RNase L to limit host antiviral protein production. This application aims to determine how RNase L inhibits mRNA export, the breadth of viruses it antagonizes, how it impacts host antiviral gene expression during pathogenic viral infections. Third, RNase L regulates the assembly of cytoplasmic antiviral ribonucleoprotein complexes. Specifically, RNase L inhibits the assembly of stress granules and promotes the assembly of an alternative stress granule-like ribonucleoprotein complex termed RNase L-dependent body. RNase L-dependent bodies are the predominant antiviral granule assembled in response to SARS-CoV-2 or dengue virus infection, yet their function is completely unknown. This application aims to determine the function of antiviral stress granules and RNase L-dependent bodies and to determine how their regulation by RNase L alters the antiviral response. Understanding the mechanisms and functions of these cellular processes will advance our understanding of the OAS/RNase L pathway, innate immune antiviral gene induction, and virology. Moreover, it will promote general medicine by broadly characterizing fundamental cellular, molecular, and RNA biology that is relevant to non-infectious diseases, including autoimmune diseases, neurodegeneration, and cancer. Lastly, the proposed research will support the development of promising antiviral, immunomodulatory, and anticancer therapies based on RNase L biology.",
                "keywords": [
                    "2019-nCoV",
                    "Acceleration",
                    "Antiviral Response",
                    "Autoimmune Diseases",
                    "Biology",
                    "Cell Nucleus",
                    "Cell physiology",
                    "Complex",
                    "Cytoplasm",
                    "Cytoplasmic Granules",
                    "Dengue Infection",
                    "Dengue Virus",
                    "Development",
                    "Disease",
                    "Gene Expression",
                    "Immune",
                    "Influenza A virus",
                    "Interferon Type I",
                    "Knowledge",
                    "Malignant Neoplasms",
                    "Mediating",
                    "Medicine",
                    "Messenger RNA",
                    "Molecular",
                    "Nerve Degeneration",
                    "Nuclear",
                    "Pathogenicity",
                    "Pathway interactions",
                    "Process",
                    "Production",
                    "Protein Biosynthesis",
                    "RNA",
                    "Regulation",
                    "Research",
                    "Ribonucleases",
                    "Ribonucleoproteins",
                    "Ribosomes",
                    "Translations",
                    "Viral",
                    "Viral Genes",
                    "Viral Proteins",
                    "Virus",
                    "Virus Diseases",
                    "cancer therapy",
                    "gene induction",
                    "immunoregulation",
                    "mRNA Decay",
                    "mRNA Export",
                    "pathogenic virus",
                    "programs",
                    "response",
                    "stress granule",
                    "virology"
                ],
                "approved": true
            }
        },
        {
            "type": "Grant",
            "id": "12283",
            "attributes": {
                "award_id": "3R01HD097107-05S1",
                "title": "Using Re-inforcement Learning to Automatically Adapt a Remote Therapy Intervention (RTI) for Reducing Adolescent Violence Involvement",
                "funder": {
                    "id": 4,
                    "ror": "https://ror.org/01cwqze88",
                    "name": "National Institutes of Health",
                    "approved": true
                },
                "funder_divisions": [
                    "NIH Office of the Director"
                ],
                "program_reference_codes": [],
                "program_officials": [
                    {
                        "id": 27515,
                        "first_name": "LEAH KAYE",
                        "last_name": "Gilbert",
                        "orcid": null,
                        "emails": "",
                        "private_emails": "",
                        "keywords": null,
                        "approved": true,
                        "websites": null,
                        "desired_collaboration": null,
                        "comments": null,
                        "affiliations": []
                    }
                ],
                "start_date": "2023-09-01",
                "end_date": "2024-03-31",
                "award_amount": 496859,
                "principal_investigator": {
                    "id": 28177,
                    "first_name": "Patrick Michael",
                    "last_name": "Carter",
                    "orcid": null,
                    "emails": "",
                    "private_emails": "",
                    "keywords": null,
                    "approved": true,
                    "websites": null,
                    "desired_collaboration": null,
                    "comments": null,
                    "affiliations": []
                },
                "other_investigators": [],
                "awardee_organization": {
                    "id": 770,
                    "ror": "",
                    "name": "UNIVERSITY OF MICHIGAN AT ANN ARBOR",
                    "address": "",
                    "city": "",
                    "state": "MI",
                    "zip": "",
                    "country": "United States",
                    "approved": true
                },
                "abstract": "Homicide is a leading cause of death for adolescents (age:14-24), disproportionately impacting African-American populations. Urban EDs are a critical opportunity for violence prevention, with >600,000 adolescents/year seeking treatment for violence-related injuries. In our study of violently-injured youth in urban EDs, we found that within 2-years, 37% returned for a repeat violent injury, 59% experienced firearm violence, 38% were arrested, and 1% died. Despite this, strategies to decrease repeat violence after an ED visit have not been well studied. Given our work demonstrating that single session ED interventions are efficacious reducing violence in lower risk adolescents, the application of this therapy, expanded to address greater problem severity over multiple sessions and enhanced by including care management, represents a potentially efficacious approach for altering risk trajectories of higher-risk violently-injured adolescents. Our recent pilot of this approach (S-RTI) was well received, addressing problems identified in prior multisession interventions (e.g., transportation) with the addition of remote therapy (e.g., phone). While innovative/promising, this S-RTI approach is resource intensive and does not address heterogeneity in treatment responses. By contrast, adaptive strategies allow for “just-in-time” tailoring that provides a balance between too much and not enough intervention and enhances outcomes while reducing cost. Reinforcement learning is an artificial intelligence domain that allows computer systems to “learn” from the success of prior treatments and is a promising approach to constructing adaptive “just-in-time” interventions. For this study, we are testing two versions of an RTI, a standard RTI condition (S-RTI) comprised of a single ED session followed by 5 remote sessions, and an adaptive RTI version (AI-RTI) optimized by reinforcement learning to step up/down the intensity of treatment between three levels (i.e., remote therapy, electronic bot messaging, assessment only) based on patient response to daily survey assessments. The original study aims were: 1) To refine/adapt our RTI for delivery using two packages (S-RTI; AI-RTI); 2) To conduct a 3- arm RCT enrolling 750 violently-injured adolescents seeking ED care (age:14-24) to compare efficacy of S-RTI (n=250), AI-RTI (n=300), and control (n=200); and, 3) To evaluate adaptability of the AI-RTI RL algorithm by comparing the first 50% of enrollees to the second 50% on process variables (e.g., engagement). Primary outcomes (6-, 12-months) include aggression and victimization. Secondary outcomes include ED recidivism for violent injury, substance use, mental health symptoms, and criminal justice involvement. While the current study holds promise for addressing elevated rates of violence, as well as key health disparities, among socio- disadvantaged youth, the clinical trial has experienced challenges stemming from COVID. This request for supplemental administrative funds is focused on adding a clinical recruitment site (to the currently enrolling sites), as well as clinical and research staff to avoid reducing scientific scope and to enhance the project’s ability to achieve the original study aims/goals, preserving the potential for high public health impact reducing violence.",
                "keywords": [
                    "Accident and Emergency department",
                    "Address",
                    "Administrative Supplement",
                    "Adolescent",
                    "Affect",
                    "African American",
                    "African American population",
                    "Aggressive behavior",
                    "Algorithms",
                    "Artificial Intelligence",
                    "Behavior Therapy",
                    "Cause of Death",
                    "Clinical",
                    "Clinical Trials",
                    "Computer Systems",
                    "Criminal Justice",
                    "Disadvantaged",
                    "Electronics",
                    "Emergency Care",
                    "Emergency department visit",
                    "Enrollment",
                    "Equilibrium",
                    "Funding",
                    "Goals",
                    "Health Services Accessibility",
                    "Heterogeneity",
                    "Homicide",
                    "Injury",
                    "Intervention",
                    "Learning",
                    "Managed Care",
                    "Mental Health",
                    "Outcome",
                    "Population",
                    "Process",
                    "Psychological reinforcement",
                    "Public Health",
                    "Remote session",
                    "Research",
                    "Resources",
                    "Risk",
                    "Sampling",
                    "Severities",
                    "Site",
                    "Surveys",
                    "Symptoms",
                    "Telephone",
                    "Testing",
                    "Text Messaging",
                    "Therapeutic Intervention",
                    "Time",
                    "Transportation",
                    "Urban Community",
                    "Victimization",
                    "Violence",
                    "Violent injury",
                    "Work",
                    "Youth",
                    "access disparities",
                    "arm",
                    "artificial intelligence algorithm",
                    "assault",
                    "comparative efficacy",
                    "coronavirus disease",
                    "cost",
                    "efficacious intervention",
                    "experience",
                    "gun violence",
                    "health disparity",
                    "high risk",
                    "innovation",
                    "intervention delivery",
                    "patient response",
                    "preservation",
                    "primary outcome",
                    "recidivism",
                    "recruit",
                    "remote therapy",
                    "secondary outcome",
                    "stem",
                    "substance use",
                    "success",
                    "treatment response",
                    "violence prevention"
                ],
                "approved": true
            }
        },
        {
            "type": "Grant",
            "id": "12284",
            "attributes": {
                "award_id": "1R01DA058991-01",
                "title": "Understanding the short- and long-term effects of the COVID-19 pandemic on the overdose crisis",
                "funder": {
                    "id": 4,
                    "ror": "https://ror.org/01cwqze88",
                    "name": "National Institutes of Health",
                    "approved": true
                },
                "funder_divisions": [
                    "National Institute on Drug Abuse (NIDA)"
                ],
                "program_reference_codes": [],
                "program_officials": [
                    {
                        "id": 21283,
                        "first_name": "JULIA BETH",
                        "last_name": "Zur",
                        "orcid": null,
                        "emails": "",
                        "private_emails": "",
                        "keywords": null,
                        "approved": true,
                        "websites": null,
                        "desired_collaboration": null,
                        "comments": null,
                        "affiliations": []
                    }
                ],
                "start_date": "2023-09-30",
                "end_date": "2028-07-31",
                "award_amount": 1038834,
                "principal_investigator": {
                    "id": 21444,
                    "first_name": "Magdalena",
                    "last_name": "Cerda",
                    "orcid": null,
                    "emails": "",
                    "private_emails": "",
                    "keywords": null,
                    "approved": true,
                    "websites": null,
                    "desired_collaboration": null,
                    "comments": null,
                    "affiliations": [
                        {
                            "id": 832,
                            "ror": "",
                            "name": "NEW YORK UNIVERSITY SCHOOL OF MEDICINE",
                            "address": "",
                            "city": "",
                            "state": "NY",
                            "zip": "",
                            "country": "United States",
                            "approved": true
                        }
                    ]
                },
                "other_investigators": [
                    {
                        "id": 28178,
                        "first_name": "SAMUEL R",
                        "last_name": "FRIEDMAN",
                        "orcid": null,
                        "emails": "",
                        "private_emails": "",
                        "keywords": null,
                        "approved": true,
                        "websites": null,
                        "desired_collaboration": null,
                        "comments": null,
                        "affiliations": []
                    }
                ],
                "awardee_organization": {
                    "id": 832,
                    "ror": "",
                    "name": "NEW YORK UNIVERSITY SCHOOL OF MEDICINE",
                    "address": "",
                    "city": "",
                    "state": "NY",
                    "zip": "",
                    "country": "United States",
                    "approved": true
                },
                "abstract": "Overdose has risen sharply during the COVID-19 pandemic, highlighting an urgent need to understand the impact of disasters on overdose. We need research to identify the types of policy measures that can prevent a similar increase in overdose in future disasters. We also need to understand why certain communities are particularly vulnerable to experiencing rises in overdose during and after a disaster, so that we can optimally target prevention and disaster response efforts. We propose to use Big Events Theory as a framework to: 1) study the COVID-19 pandemic and its effects on overdose and related outcomes; 2) identify policy responses to COVID-19 that affected individual-level overdose risk; and 3) examine how the pandemic's impact on overdose risk varied across communities and populations. We hypothesize that COVID-19 containment policies (e.g., workplace closings) contributed to social isolation, increasing the risk of consuming drugs alone and limiting access to treatment and harm reduction services, thus increasing overdose risk. In contrast, public health (e.g., take-home methadone waivers) and economic support policy responses to COVID-19 (e.g., housing eviction moratoria) may have eased access to health services for people who use drugs (PWUD) and alleviated economic difficulties arising from the pandemic, blocking health and economic pathways through which the pandemic could increase overdose risk. We hypothesize that communities with more structural sources of despair (e.g., high rates of unemployment, poverty), and those that concurrently experienced other major societal crises (natural disasters, political conflict, mass shootings) were more vulnerable to the effects of COVID-19 on overdose. In contrast, social and economic policies enacted before the pandemic to protect vulnerable populations (e.g., higher state Medicaid income threshold) may have reduced the impact of the pandemic on overdose risk. Our Aims are to: (1) Determine how individual overdose risk in localities (overall and by race/ethnicity) changed over 2019–2025 after county-level elevations in COVID-19 health burden (hospitalizations, deaths). (2) Determine which county- and state-level policies targeting COVID-19 infection containment, public health of PWUDs, and economic support during the pandemic mediated relations between changes in county-level COVID-19 burden and changes in overdose incidence, overall and by race/ethnicity. (3) Identify which community conditions affected the strength of the relationships between changes in county-level COVID-19 burden and individual overdose risk, overall and by race/ethnicity, including: a) pre-existing community structural characteristics (e.g., poverty rate); b) pre-existing policies to protect vulnerable populations (e.g., state Medicaid program income threshold); and c) intersecting crises. We will build a multi-center cohort of ~2.4 million patients aged 18+ in six PCORnet® networks across the country to track the impact of community COVID-19 burden on individual overdose risk. Our study findings will inform the response to the current overdose crisis and to future disasters.",
                "keywords": [
                    "Address",
                    "Adoption",
                    "Adverse drug effect",
                    "Affect",
                    "Black Populations",
                    "Black race",
                    "Buffers",
                    "COVID-19",
                    "COVID-19 impact",
                    "COVID-19 pandemic",
                    "COVID-19 pandemic effects",
                    "Cessation of life",
                    "Characteristics",
                    "Communities",
                    "Conflict (Psychology)",
                    "Consumption",
                    "Containment",
                    "Country",
                    "County",
                    "Diagnosis",
                    "Disasters",
                    "Drug usage",
                    "Drug user",
                    "Economic Policy",
                    "Economically Deprived Population",
                    "Economics",
                    "Ethnic Origin",
                    "Event",
                    "Fentanyl",
                    "Future",
                    "Harm Reduction",
                    "Health",
                    "Health Services",
                    "Health Services Accessibility",
                    "Heterogeneity",
                    "Hispanic Populations",
                    "Home",
                    "Hospitalization",
                    "Housing",
                    "Incidence",
                    "Income",
                    "Individual",
                    "Inequality",
                    "Inequity",
                    "Investigation",
                    "Knowledge",
                    "Measures",
                    "Mediating",
                    "Medicaid",
                    "Methadone",
                    "Modeling",
                    "Naloxone",
                    "Natural Disasters",
                    "Outcome",
                    "Overdose",
                    "Pathway interactions",
                    "Patients",
                    "Pattern",
                    "Pharmaceutical Preparations",
                    "Policies",
                    "Politics",
                    "Population",
                    "Poverty",
                    "Prevalence",
                    "Prevention",
                    "Public Health",
                    "Public Policy",
                    "Race",
                    "Relapse",
                    "Research",
                    "Research Design",
                    "Risk",
                    "Role",
                    "SARS-CoV-2 infection",
                    "Services",
                    "Social Policies",
                    "Social isolation",
                    "Source",
                    "Structure",
                    "Subgroup",
                    "Testing",
                    "Unemployment",
                    "Urban Community",
                    "Vulnerable Populations",
                    "Wages",
                    "Wing",
                    "Workplace",
                    "aged",
                    "climate change",
                    "cohort",
                    "drug market",
                    "experience",
                    "future pandemic",
                    "improved",
                    "insight",
                    "long term consequences of COVID-19",
                    "man",
                    "mass shooting",
                    "mortality",
                    "opioid use disorder",
                    "overdose risk",
                    "pandemic disease",
                    "pandemic impact",
                    "prevent",
                    "programs",
                    "residential segregation",
                    "response",
                    "social",
                    "social disparities",
                    "theories",
                    "waiver"
                ],
                "approved": true
            }
        },
        {
            "type": "Grant",
            "id": "12285",
            "attributes": {
                "award_id": "1R43PS005274-01",
                "title": "Rapid molecular diagnostic assay for detection of Hepatitis C virus at point of care",
                "funder": {
                    "id": 4,
                    "ror": "https://ror.org/01cwqze88",
                    "name": "National Institutes of Health",
                    "approved": true
                },
                "funder_divisions": [],
                "program_reference_codes": [],
                "program_officials": [],
                "start_date": "2023-09-30",
                "end_date": "2024-09-29",
                "award_amount": 252073,
                "principal_investigator": {
                    "id": 28179,
                    "first_name": "Yogesh",
                    "last_name": "Chander",
                    "orcid": null,
                    "emails": "",
                    "private_emails": "",
                    "keywords": null,
                    "approved": true,
                    "websites": null,
                    "desired_collaboration": null,
                    "comments": null,
                    "affiliations": []
                },
                "other_investigators": [],
                "awardee_organization": {
                    "id": 2080,
                    "ror": "",
                    "name": "VARIGEN BIOSCIENCES CORPORATION",
                    "address": "",
                    "city": "",
                    "state": "WI",
                    "zip": "",
                    "country": "United States",
                    "approved": true
                },
                "abstract": "Hepatitis C virus (HCV) infections are major cause of morbidity and mortality worldwide. It is estimated that 3% of world population is infected with HCV, with infection rates being higher in low- and middle-income countries and disconnected populations in developed countries. Most people infected with HCV are not aware of infection because of lack of both symptoms (subclinical infection) and regular screening. Barriers to regular screening for HCV are due to the complexity of testing algorithms, cost of diagnostic tests, and availability of point of care (POC) diagnostic tests.  The goal of this application is to demonstrate feasibility of a comprehensive molecular detection system, HCVAmp, suitable for use at POC for detection of HCV. The proposed assay will be based on a novel “Duplex reverse transcription- loop mediated isothermal amplification (Duplex RT-LAMP)” technology and performed on a commercially available benchtop instrument (AmpliFire®). While methods currently used for detection of LAMP amplification products are unable to differentiate between different targets, Duplex RT-LAMP allows detection of two targets in the same reaction. This is feasible because of use of fluorescent labels (FAM, HEX etc.) on target specific primers and a specially formulated 10X Isothermal Master Mix. Another innovation that is the basis of this application is a new thermostable Bst polymerase which has been engineered for reverse transcriptase (RT) activity. Total assay time will be 30 minutes including sample preparation with minimal hands-on time and without need of any additional equipment, such as pipettes, centrifuge etc. Results will be displayed on-screen as positive or negative for HCV, minimizing error’s caused by user interpretation. Successful completion of this project will lead to: • Development of a diagnostic kit (HCVAmp) for the detection of HCV genotypes 1 – 3 (including subtypes) at POC. • Minimal hands-on and total assay time (TAT) of 30 minute including sample preparation. • A simple and easy to use sample preparation method for processing of samples at POC. • Diagnostic sensitivity and specificity comparable to reference method. • Dried reagents for storage at ambient temperature. • Platform technology for at home diagnosis of other pathogens such as HBV, Treponema, SARS-CoV-2, influenza etc.",
                "keywords": [
                    "2019-nCoV",
                    "Algorithms",
                    "Biological Assay",
                    "Biological Sciences",
                    "Blood specimen",
                    "Buffers",
                    "Clinical",
                    "DNA",
                    "DNA-Directed DNA Polymerase",
                    "Detection",
                    "Developed Countries",
                    "Development",
                    "Diagnosis",
                    "Diagnostic",
                    "Diagnostic Procedure",
                    "Diagnostic Reagent Kits",
                    "Diagnostic Sensitivity",
                    "Diagnostic tests",
                    "Dyes",
                    "Enzymes",
                    "Equipment",
                    "Evaluation",
                    "Fluorescence",
                    "Formulation",
                    "Freeze Drying",
                    "Genes",
                    "Genotype",
                    "Goals",
                    "HCV screening",
                    "Health Personnel",
                    "Hepatitis B Virus",
                    "Hepatitis C",
                    "Hepatitis C virus",
                    "Home",
                    "Human",
                    "Immunoassay",
                    "Improve Access",
                    "Infection",
                    "Influenza",
                    "Infrastructure",
                    "Kinetics",
                    "Label",
                    "Mediating",
                    "Methods",
                    "Modality",
                    "Molecular",
                    "Molecular Diagnostic Testing",
                    "Monitor",
                    "Morbidity - disease rate",
                    "Nucleic Acids",
                    "Performance",
                    "Persons",
                    "Phase",
                    "Polymerase",
                    "Population",
                    "Preparation",
                    "RNA",
                    "RNA-Directed DNA Polymerase",
                    "Rapid diagnostics",
                    "Reaction",
                    "Reagent",
                    "Residual state",
                    "Reverse Transcriptase Polymerase Chain Reaction",
                    "Reverse Transcription",
                    "Reverse engineering",
                    "Sampling",
                    "Sensitivity and Specificity",
                    "Sequence Alignment",
                    "Specificity",
                    "Symptoms",
                    "System",
                    "Technology",
                    "Temperature",
                    "Testing",
                    "Time",
                    "Training",
                    "Treponema",
                    "Tube",
                    "Work",
                    "amplification detection",
                    "base",
                    "beta Actin",
                    "cost",
                    "design",
                    "detection assay",
                    "detection platform",
                    "diagnostic platform",
                    "ds-DNA",
                    "fluorophore",
                    "infection rate",
                    "innovation",
                    "instrument",
                    "internal control",
                    "isothermal amplification",
                    "low and middle-income countries",
                    "molecular diagnostics",
                    "mortality",
                    "novel",
                    "pathogen",
                    "performance tests",
                    "point of care",
                    "point-of-care detection",
                    "point-of-care diagnostics",
                    "screening",
                    "thermostability",
                    "viral RNA"
                ],
                "approved": true
            }
        },
        {
            "type": "Grant",
            "id": "12286",
            "attributes": {
                "award_id": "1U18HS029911-01",
                "title": "Advancing Long COVID Care in our Community through Access, Equity, and Collaboration",
                "funder": {
                    "id": 4,
                    "ror": "https://ror.org/01cwqze88",
                    "name": "National Institutes of Health",
                    "approved": true
                },
                "funder_divisions": [
                    "Agency for Healthcare Research and Quality (AHRQ)"
                ],
                "program_reference_codes": [],
                "program_officials": [
                    {
                        "id": 22615,
                        "first_name": "Brent",
                        "last_name": "Sandmeyer",
                        "orcid": null,
                        "emails": "",
                        "private_emails": "",
                        "keywords": null,
                        "approved": true,
                        "websites": null,
                        "desired_collaboration": null,
                        "comments": null,
                        "affiliations": []
                    }
                ],
                "start_date": "2023-09-30",
                "end_date": "2028-09-29",
                "award_amount": 962720,
                "principal_investigator": {
                    "id": 28180,
                    "first_name": "Abby Ling-Lee",
                    "last_name": "Cheng",
                    "orcid": null,
                    "emails": "",
                    "private_emails": "",
                    "keywords": null,
                    "approved": true,
                    "websites": null,
                    "desired_collaboration": null,
                    "comments": null,
                    "affiliations": []
                },
                "other_investigators": [
                    {
                        "id": 28181,
                        "first_name": "Jonas",
                        "last_name": "Marschall",
                        "orcid": null,
                        "emails": "",
                        "private_emails": "",
                        "keywords": null,
                        "approved": true,
                        "websites": null,
                        "desired_collaboration": null,
                        "comments": null,
                        "affiliations": []
                    },
                    {
                        "id": 28182,
                        "first_name": "Amy",
                        "last_name": "McQueen",
                        "orcid": null,
                        "emails": "",
                        "private_emails": "",
                        "keywords": null,
                        "approved": true,
                        "websites": null,
                        "desired_collaboration": null,
                        "comments": null,
                        "affiliations": []
                    }
                ],
                "awardee_organization": {
                    "id": 827,
                    "ror": "",
                    "name": "WASHINGTON UNIVERSITY",
                    "address": "",
                    "city": "",
                    "state": "MO",
                    "zip": "",
                    "country": "United States",
                    "approved": true
                },
                "abstract": "Long COVID manifests differently for each person and can contribute to disabling, life-changing symptoms such as extreme fatigue, cognitive dysfunction, breathing difficulty, and autonomic dysfunction in people across the age spectrum, including in people who were previously healthy and in people who had minimal or no symptoms associated with acute COVID-19 infection. Multidisciplinary Long COVID clinics were a mainstay of patient support during the initial phases of the COVID-19 pandemic, but as the pandemic is shifting to a new phase, care models must also evolve in order to meet the complex medical, rehabilitative, and social needs of the continually growing number of people who are affected by Long COVID. The purpose of this project is to transform an existing, university-based Long COVID clinic into a broader Long COVID community network in order to expand equitable access to care, improve the patient care experience, and support primary care practitioners. This project will invest in two particularly underserved populations: 1) the Black community in St. Louis, Missouri, which is a historically mistreated population who continues to be marginalized by previously sanctioned segregation practices; and 2) rural communities across Missouri. Aim 1 is to expand equitable access to Long COVID care by: 1) building clinical capacity, and 2) removing structural barriers to care. This will be accomplished by: 1) hiring additional clinicians for the Long COVID Clinic in order to reduce wait times; and 2) removing patient requirements for clinic evaluation that disproportionately affect underserved populations. Aim 2 is to improve the Long COVID care experience by: 1) streamlining care that crosses multiple disciplines and physical care sites, and 2) supporting patients’ social needs. This will be accomplished by: 1) supporting a clinical case manager to directly assist patients with coordinating medical care and connecting with community resources, and 2) iteratively assessing and addressing referral challenges between clinics. Aim 3 is to support primary care teams as they care for patients with Long COVID by co-creating: 1) educational resources for PCPs, and 2) streamlined communication and referral pathways between PCPs and specialty clinicians. This will be accomplished by engaging multiple key stakeholders to: 1) develop multi- modality educational materials related to Long COVID patient assessment and management; 2) disseminate materials via culturally and logistically preferred approaches (including via established, trusted community intermediaries and via an established ECHO (Enhanced for Community Healthcare Outcomes) virtual educational infrastructure); and 3) refine existing handoff processes to minimize the administrative workload on PCP teams and facilitate their ability to meet patients’ needs. Continuous stakeholder input, comprehensive data tracking, and iterative needs assessments using mixed methods approaches will facilitate ongoing project evaluation and adaptation in order to respond to the community’s evolving needs.",
                "keywords": [],
                "approved": true
            }
        },
        {
            "type": "Grant",
            "id": "12287",
            "attributes": {
                "award_id": "1R01GM152743-01",
                "title": "Collaborative Research: DMS/NIGMS 1: Identifiability investigation of Multi-scale Models of Infectious Diseases",
                "funder": {
                    "id": 4,
                    "ror": "https://ror.org/01cwqze88",
                    "name": "National Institutes of Health",
                    "approved": true
                },
                "funder_divisions": [
                    "National Institute of General Medical Sciences (NIGMS)"
                ],
                "program_reference_codes": [],
                "program_officials": [
                    {
                        "id": 12060,
                        "first_name": "Han",
                        "last_name": "Nguyen",
                        "orcid": null,
                        "emails": "",
                        "private_emails": "",
                        "keywords": null,
                        "approved": true,
                        "websites": null,
                        "desired_collaboration": null,
                        "comments": null,
                        "affiliations": []
                    }
                ],
                "start_date": "2023-09-27",
                "end_date": "2026-07-31",
                "award_amount": 183401,
                "principal_investigator": {
                    "id": 28183,
                    "first_name": "Stanca M.",
                    "last_name": "Ciupe",
                    "orcid": null,
                    "emails": "",
                    "private_emails": "",
                    "keywords": null,
                    "approved": true,
                    "websites": null,
                    "desired_collaboration": null,
                    "comments": null,
                    "affiliations": []
                },
                "other_investigators": [],
                "awardee_organization": {
                    "id": 839,
                    "ror": "",
                    "name": "VIRGINIA POLYTECHNIC INST AND ST UNIV",
                    "address": "",
                    "city": "",
                    "state": "VA",
                    "zip": "",
                    "country": "United States",
                    "approved": true
                },
                "abstract": "The emergence and re-emergence of pathogens and their impact on society has reinforced the need for  integration and synergy across scientific fields and biological scales in order to advance understanding,  predicting, and responding to pathogen spread. Multi-scale mathematical models that consider the timing  and length of individual infections when modeling transmission into the population can aid  recommendations for optimal interventions. One shortcoming when evaluating data using multi-scale  models comes from data scarcity in the expansion stages of the infection and transmission, the differences  in data magnitude and frequency at each scale, together with the complexity of the models considered. To  determine the source of combined biases in parameter estimation, we will use a combined empirical-theoretical approach for investigating structural and practical parameter identifiability of multi-scale models  of infectious diseases that may inform optimal experimental design. The proposed research will facilitate a  better understanding of the sources of uncertainty when fitting multi-scale models to multi-scale infectious  disease data, with a focus on Usutu and SARS-CoV-2 viruses. By combining empirical and theoretical  approaches we aim to determine structural and practical parameter identifiability of multi-scale models, to  inform optimal experimental design, and to improve our ability to make predictions and suggest  interventions. Our proposal will focus on three major mathematical challenges: (1) Developing methods for  improving practical identifiability in within-host systems; (2) Use experimental data to inform development of  transmission models; (3) Build a quantitative framework to predict parameter identifiability in multi-scale  systems. The overarching goal of the proposed work is to integrate multi-scale mathematical model  development and statistical models for data fitting with collection of longitudinal virus titers and probability  of transmission data in order to decrease uncertainty and improve results reproducibility. This will ultimately  improve our understanding of infection disease transmission and persistence.",
                "keywords": [
                    "2019-nCoV",
                    "Animals",
                    "Biological",
                    "Birds",
                    "Case Study",
                    "Cessation of life",
                    "Collaborations",
                    "Collection",
                    "Communicable Diseases",
                    "Couples",
                    "Culicidae",
                    "Data",
                    "Data Collection",
                    "Data Set",
                    "Databases",
                    "Development",
                    "Disease",
                    "Disease Outbreaks",
                    "Disease Progression",
                    "Education",
                    "Educational workshop",
                    "Epidemiology",
                    "Experimental Designs",
                    "Frequencies",
                    "Goals",
                    "Grant",
                    "Health",
                    "Human",
                    "Immune system",
                    "Immunologic Markers",
                    "Incidence",
                    "Individual",
                    "Infection",
                    "Infectious Agent",
                    "Interdisciplinary Study",
                    "Intervention",
                    "Investigation",
                    "Length",
                    "Link",
                    "Mathematics",
                    "Measurement",
                    "Methods",
                    "Modeling",
                    "National Institute of General Medical Sciences",
                    "Noise",
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            "type": "Grant",
            "id": "12288",
            "attributes": {
                "award_id": "1U01NS124961-01A1",
                "title": "Clinical Trial Readiness for Children 0-5 years with Congenital Muscular Dystrophy Secondary to LAMA2 Mutations",
                "funder": {
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                        "first_name": "LINA FERNANDA",
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                "start_date": "2023-09-18",
                "end_date": "2028-08-31",
                "award_amount": 1295529,
                "principal_investigator": {
                    "id": 28185,
                    "first_name": "Anne M",
                    "last_name": "Connolly",
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                "awardee_organization": {
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                    "name": "RESEARCH INST NATIONWIDE CHILDREN'S HOSP",
                    "address": "",
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                    "state": "OH",
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                    "country": "United States",
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                "abstract": "This proposal’s overall goal is to hasten drug development for children < 5 years with congenital muscular dystrophy secondary to laminin α2-related dystrophies (LAMA2-RD) mutations. Excellent mouse models of differing severity improved the understanding of pathogenesis in LAMA2-RD. Therapeutic strategies, including protein replacement and apoptosis inhibition (Phase 1), linker gene transfer, and compensatory gene upregulation (pre- clinical proof of concept), are all at various developmental stages but are expected to come to clinical trials in 2-3 years. While all these advances are promising, currently, no validated clinical outcome assessments (COA) are available for children with LAMA2-RD < 5 years. Thus, the need to validate outcome measures and biomarkers is urgent for children (< 5 years) with genetically confirmed LAMA2-RD. Successfully translating any therapy must include these youngest children for whom strength or function-based approaches designed for older “cooperative children” do not work. Clinical trial readiness for infants and young children is particularly critical since therapeutic interventions, if successful, are likely to have the best response when given early. The specific aims of our proposal are to 1) Validate motor function as COA for children with LAMA2-RD, 2) Establish minimal clinically important differences for motor COAs by anchoring them to the clinical global impressions scale, 3) Determine what cohort characteristics will best inform clinical trial eligibility, and 4) Validate novel biomarkers (cross-sectionally measure biceps and rectos femoris by ultrasound) and creatine kinase levels over time. To achieve these aims, we propose a 14-site multicenter prospective 2-year study of 44 children < 5 years at enrollment. Detailed training of at least two clinical evaluators from each collaborating site will take place at the lead institution, Nationwide Children’s Hospital, before enrollment and again in Year 3. We selected the sites based on their expertise in pediatric neuromuscular clinical trials. LAMA2-RD is ultra-rare, and these children are often medically fragile. Therefore, we also selected geographically diverse locations to minimize travel and burden of trial participation. A novel COA developed by necessity during the COVID-19 Pandemic is video assessments of all motor function COAs, further allowing less travel for children. Our partnerships with advocacy groups, including Cure CMD (Congenital Muscular Dystrophy) and the Muscular Dystrophy Association, will allow us to successfully recruit children using a spoke and hub model. The proposal will develop and validate COAs for children < 5 years with LAMA2-RD and will inform future clinical trial design and interpretation. Furthermore, once validated, these COAs are very likely to be successful for children with other rare disorders affecting motor development in early infancy.",
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