Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=1383&sort=funder
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=funder", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1419&sort=funder", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1384&sort=funder", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1382&sort=funder" }, "data": [ { "type": "Grant", "id": "11771", "attributes": { "award_id": "3R01MH127315-02S1", "title": "Cerebrospinal fluid (CSF) and peripheral markers of the neuropsychiatric sequelae of COVID-19: The Generation C-SF pregnancy study", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Mental Health (NIMH)" ], "program_reference_codes": [], "program_officials": [ { "id": 7203, "first_name": "Victoria", "last_name": "Arango", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-06-14", "end_date": "2024-07-31", "award_amount": 52799, "principal_investigator": { "id": 27545, "first_name": "Maria De Las Mercedes", "last_name": "Perez Rodriguez", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 7205, "first_name": "Lotje Dorothee", "last_name": "de Witte", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 625, "ror": "https://ror.org/04a9tmd77", "name": "Icahn School of Medicine at Mount Sinai", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "The placenta is an integral organ during pregnancy, being a regulator of the in-utero environment including maternal neuroendocrine changes. Previous efforts have begun to elucidate a connection between HPA-axis gene expression in the placenta and maternal mental health, implicating that dysregulation of gene expression in the placenta has potential consequences for both the physical and mental health of the pregnant individual. Fully interrogating this connection is imperative, and there is an urgent need to expand our understanding of the role placental gene expression plays. This is especially important in the context of the coronavirus disease 2019 (covid-19) pandemic, as infections and the inflammatory responses they elicit have the potential to have a negative effect on maternal mental health. The parent study (Generation-CSF) is currently using a large ongoing pregnancy cohort to investigate the impact of SARS-CoV-2 infection and subsequent inflammatory changes on maternal mental health and cognition through paired blood and CSF (Cerebrospinal fluid) samples and psychiatric and cognitive assessments during and after pregnancy. This supplement aims to expand upon this investigation by clarifying the role that the placenta, as a regulator of neuroendocrine chances, could be playing in this relationship. By utilizing already collected placental samples and existing RNAseq data to investigate immune and inflammation genes in the placenta, which have yet to be explored in connection to maternal mental health, this supplement provides important additional information about what could be driving the proposed negative system wide changes that occur after infection during pregnancy. We hypothesize that SARS-CoV-2 infection during pregnancy will be positively associated with the expression of immune and inflammation markers in the placenta and maternal blood and that this upregulation will serve as a driver for increased EPDS scores at birth and at 6 weeks postpartum. In Aim 1 we will examine the association between SARS-CoV-2 infection and the expression of a curated list of 497 immune and inflammation related genes in the placenta with EPDS scores at birth and 6 weeks postpartum. In Aim 2 we will examine the association between cytokine levels in the blood (Il-1b, Il-17A, Il-6, CRP) and placental genes linked to SARS-CoV-2 and postpartum depression (EPDS scores) at birth and at 6 weeks postpartum. Finally, in Aim 3 we will validate key findings/candidate genes from Aim 1 and 2 in placental samples using quantitative gene expression profiling (qPCR).", "keywords": [ "2019-nCoV", "Affect", "Autoimmune", "Automobile Driving", "Biological", "Biological Markers", "Birth", "Blood", "Blood specimen", "COVID-19 pandemic", "Candidate Disease Gene", "Cerebrospinal Fluid", "Cognition", "Data", "Databases", "Doctor of Philosophy", "Environment", "Foundations", "Funding", "Future", "Gene Expression", "Gene Expression Profiling", "Generations", "Genes", "Genetic Transcription", "Goals", "Grant", "Health", "Immune", "Immune response", "Immunologic Markers", "Individual", "Infection", "Inflammation", "Inflammatory", "Inflammatory Response", "Investigation", "Letters", "Link", "Maternal Health", "Measures", "Mental Health", "Mentorship", "Molecular Profiling", "Neurobehavioral Manifestations", "Neurosecretory Systems", "Organ", "Parents", "Pathway interactions", "Peripheral", "Physicians", "Placenta", "Play", "Postpartum Depression", "Postpartum Period", "Pregnancy", "Process", "Reproductive Health", "Research", "Role", "SARS-CoV-2 exposure", "SARS-CoV-2 infection", "Sampling", "Scientist", "System", "Tissues", "Up-Regulation", "career", "cognitive testing", "cohort", "cytokine", "differential expression", "early pregnancy", "experience", "hypothalamic-pituitary-adrenal axis", "in utero", "inflammatory marker", "neuropsychiatric sequelae of COVID-19", "novel", "offspring", "parent grant", "peripartum depression", "physical conditioning", "post SARS-CoV-2 infection", "post pregnancy", "pregnant", "psychiatric symptom", "transcriptome", "transcriptome sequencing" ], "approved": true } }, { "type": "Grant", "id": "11772", "attributes": { "award_id": "1R13ES035682-01", "title": "Inhaled Aerosol Dosimetry: Advances, Applications, and Impacts on Risk Assessments and Therapeutics", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Environmental Health Sciences (NIEHS)" ], "program_reference_codes": [], "program_officials": [ { "id": 7069, "first_name": "Srikanth", "last_name": "Nadadur", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-06-15", "end_date": "2024-05-31", "award_amount": 10000, "principal_investigator": { "id": 27648, "first_name": "Robert", "last_name": "Phalen", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 971, "ror": "", "name": "UNIVERSITY OF CALIFORNIA-IRVINE", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "The COVID-19 pandemic exposed a critical lack of our understanding the airborne transmission of infectious viral agents. Deficiencies in understanding the deposition, metabolism, distribution in the body, and mechanisms of injury of aerosols (particles suspended in a gas) limit the confidence in setting air quality standards and developing new inhaled therapeutics. The delivered inhaled dose (e.g., mg/target tissues) is poorly understood due to individual differences, the complexity of aerosols, and post inhalation internal events. UC Irvine’s Air Pollution Health Effects Laboratory has been involved in basic and applied research in this area since its founding in the School of Medicine in 1974. It has initiated several topic-focused multi-disciplinary conferences on inhaled aerosols. This proposal requests support for an international conference “Inhaled Aerosol Dosimetry: Advances, Applications and Impacts on Risk Assessments and Therapeutics”, to be held adjacent to the UC Irvine campus at the Arnold and Mabel Beckman Center of the National Academies of Sciences and Engineering, in Irvine, CA 3 days in October of 2024. The conference center offers solid support including an atmosphere conducive to collegiality, inclusion, and creative thinking. The conference will bring together scientists, engineers, medical researchers, regulators, and others who normally attend separate professional meetings, and read specialty journals in relative isolation thereby inhibiting cross-discipline communications and collaborations. Our Organizing Committee of 10 men and 7 women scientists represents universities, governments, and private laboratories. They are aware of critical research needs in medicine, science, and government, as well as gender and racial inequalities. Sessions include; overviews, recent research, complex mixtures; in-vitro methods to reduce the use of live animals; computer model advances; and case studies. Each session is plenary, geared to be understandable by all attendees, and each has discussion time. The program supports cross-discipline communication and collaboration. The registration fee will cover all sessions, and transportation between the nearby airport (SNA), the hotels, and the conference center. Staff will help those with special needs and efforts will be made to attract those from underrepresented groups. Students will have a luncheon with prospective employers, and awards will be made for outstanding student posters. A Proceedings will be published, and a journal issue is planned for those papers that meet peer review standards. Startup support is provided by our University. The total budget is about $155,000, and $25,000 is requested from the NHLBI to help support staff and students, and attract attendees from underrepresented groups. Revised 11-26-2022", "keywords": [ "Aerosols", "Air", "Air Pollution", "Animals", "Applied Research", "Area", "Atmosphere", "Award", "Awareness", "Basic Science", "Budgets", "COVID-19 pandemic", "Case Study", "Collaborations", "Communication", "Complex Mixtures", "Computer Models", "Computers", "Creativeness", "Deposition", "Diagnosis", "Discipline", "Disease", "Dose", "Engineering", "Environment", "Event", "Fees", "Gases", "Gender", "Government", "Health", "In Vitro", "Individual Differences", "Inhalation", "Injury", "International", "Journals", "Laboratories", "Literature", "Lung", "Malignant Neoplasms", "Medical", "Medicine", "Metabolism", "Methods", "National Heart Lung and Blood Institute", "Occupational", "Occupations", "Paper", "Peer Review", "Physicians", "Postdoctoral Fellow", "Privatization", "Publishing", "Request for Proposals", "Research", "Research Personnel", "Risk", "Risk Assessment", "Science", "Scientist", "Solid", "Specialist", "Students", "Therapeutic", "Thinking", "Time", "Tissues", "Transportation", "Underrepresented Minority", "Underrepresented Populations", "United States National Academy of Sciences", "Universities", "Update", "Vaccines", "Viral", "Woman", "Workplace", "career", "doctoral student", "dosimetry", "frontier", "medical schools", "medical specialties", "meetings", "men", "minority scientist", "multidisciplinary", "particle", "posters", "prevent", "programs", "prospective", "racial disparity", "symposium", "transmission process" ], "approved": true } }, { "type": "Grant", "id": "11773", "attributes": { "award_id": "1R01AI162746-01A1", "title": "Mechanisms of vitamin A-dependent risk for tuberculosis progression and prevention", "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)" ], "program_reference_codes": [], "program_officials": [ { "id": 6515, "first_name": "Katrin", "last_name": "Eichelberg", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-06-15", "end_date": "2028-05-31", "award_amount": 768839, "principal_investigator": { "id": 27649, "first_name": "Brendan", "last_name": "Podell", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 323, "ror": "https://ror.org/03k1gpj17", "name": "Colorado State University", "address": "", "city": "", "state": "CO", "zip": "", "country": "United States", "approved": true }, "abstract": "Mycobacterium tuberculosis, the causative agent of Tuberculosis (TB), is the leading cause of human mortality due to an infectious disease, outside of the COVID-19 pandemic. The limited knowledge on risk factors and comorbidities for TB progression and the mechanisms by which these promote susceptibility limits the ability to develop new prevention and treatment approaches. Recently, we published data showing a causal relationship between vitamin A deficiency and progression to clinical active TB disease, carrying up to a 10-fold higher risk for human TB progression. The substantial TB risk associated with vitamin A deficiency highlights the need to understand the mechanisms by which this molecule contributes to TB pathogenesis, particularly in the context of malnutrition among TB-affected communities, which are often the same communities affected by vitamin A deficiency. Vitamin A has been shown to have an impact on both innate and cell-mediated immunity, where diverse roles in immunity convolute the potential contributions of this molecule to TB immunity. We hypothesize that vitamin A is required for effective cell-mediated immunity to control infection after exposure, and respond properly to vaccination, requiring production within the lung for development of effective immunity. The goals of this research are to better understand the contribution of vitamin A bioavailability to the development of the immune response, the metabolic perturbations of vitamin A during infection that may limit bioavailability, and how vitamin A status impacts efficacies of BCG vaccination practices. These goals will be achieved through three Aims using a guinea pig model of vitamin A deficiency developed in our laboratory. We will first determine the contribution of vitamin A bioavailability to the development of the coordinated granuloma immune response using single cell and spatial transcriptomic approaches on infected guinea pig lung tissues. Next, we will evaluate cellular, organ-level, and systemic vitamin A metabolic patterns during infection using stable heavy isotope tracing methods in the guinea pig model throughout the course of infection. Finally, the impact of vitamin A on protective efficacy of BCG vaccination, the only vaccine available for TB, will be assessed under conditions of physiologic and pathologic neonatal vitamin A deficiencies. Upon completing these experiments, we will have determined the role of vitamin A in the development of the granuloma and cell mediated immunity, the requirements for, and availability of, vitamin A at the site of infection in the lung, and the impact of existing and proposed human vitamin A supplementation programs on the efficacy of BCG vaccination. These results will elucidate mechanisms of TB disease progression, identify the role of vitamin A in TB immunity and propose informed options for preventive or therapeutic intervention on vitamin A deficiency.", "keywords": [ "Affect", "All-Trans-Retinol", "Automobile Driving", "BCG Vaccine", "Bacille Calmette-Guerin vaccination", "Biological Availability", "Birth", "CD4 Positive T Lymphocytes", "CD8-Positive T-Lymphocytes", "CD8B1 gene", "COVID-19 pandemic", "Cause of Death", "Cavia", "Cells", "Cellular Immunity", "Chronic", "Clinical", "Communicable Diseases", "Communities", "Country", "Data", "Detection", "Development", "Dietary intake", "Disease", "Disease Outcome", "Disease Progression", "Environment", "Exposure to", "Generations", "Goals", "Granuloma", "Human", "Image", "Immune", "Immune System Diseases", "Immune response", "Immunity", "Impairment", "Individual", "Infection", "Infection Control", "Intake", "Isotopes", "Knowledge", "Laboratories", "Liver", "Location", "Lung", "Lung immune response", "Malnutrition", "Measures", "Mediating", "Metabolic", "Metabolism", "Methods", "Morphology", "Mycobacterium tuberculosis", "Neonatal", "Organ", "Outcome", "Pathogenesis", "Pathologic", "Pattern", "Physiological", "Predisposition", "Pregnancy", "Prevention", "Production", "Publishing", "Research", "Risk", "Risk Factors", "Role", "Serum", "Site", "Spectrometry Mass Matrix-Assisted Laser Desorption-Ionization", "Structure of parenchyma of lung", "Supplementation", "T cell therapy", "T-Lymphocyte", "Therapeutic Intervention", "Tuberculosis", "Vaccination", "Vitamin A", "Vitamin A Deficiency", "clinical development", "comorbidity", "dietary", "experimental study", "guinea pig model", "high risk", "human mortality", "human subject", "immune function", "in vivo", "low income country", "lung development", "metabolomics", "neonate", "physiologic model", "prenatal exposure", "preventive intervention", "programs", "prophylactic", "protective efficacy", "pulmonary granuloma", "response", "single-cell RNA sequencing", "transcriptomics", "tuberculosis immunity", "vaccination strategy", "vaccine access", "vaccine failure" ], "approved": true } }, { "type": "Grant", "id": "11774", "attributes": { "award_id": "1K24AI165099-01A1", "title": "Mentoring Multidisciplinary Patient-Oriented Research in TB, HIV, and Global Health", "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)" ], "program_reference_codes": [], "program_officials": [ { "id": 23093, "first_name": "Susana", "last_name": "Mendez", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-06-23", "end_date": "2028-05-31", "award_amount": 195347, "principal_investigator": { "id": 27650, "first_name": "Nippie Sarita", "last_name": "Shah", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 265, "ror": "https://ror.org/03czfpz43", "name": "Emory University", "address": "", "city": "", "state": "GA", "zip": "", "country": "United States", "approved": true }, "abstract": "Dr. Shah is a physician-scientist with 15 years of experience leading patient-oriented research (POR) on diagnosis, treatment, and prevention of tuberculosis (TB) globally, including drug-resistant TB and TB/HIV co- infection. Her experience with U.S. and international public health programs, including the Centers for Disease Control & Prevention (CDC) where she trained and worked for a decade, provides a strong foundation for integrating research into policy and patient care. This K24 award will allow her to enhance and expand her successful mentorship in POR by providing vital protected time for training in advanced methods for studying TB transmission, and developing a structured mentoring program. Worldwide, TB is the leading cause of death among people living with HIV, with drug-resistant TB threatening decades of progress in TB and HIV control. Drug-resistant TB epidemics are driven primarily by person-to-person transmission of resistant strains, and innovative approaches to improve our understanding of TB transmission are urgently needed to guide effective interventions. Similarly, there is a need to train the next generation of scientists in multidisciplinary TB/HIV and global health POR. Dr. Shah’s robust research program supported by NIH, Gates Foundation, and CDC provides exciting training opportunities that attract trainees interested in multidisciplinary TB & HIV POR. She has a strong track record of mentorship of U.S. and international trainees in diverse areas of TB & HIV clinical research, and many of her mentees have pursued academic careers and K awards. In addition, through her role as Director of the Clinical Core for the NIH P30 Emory/Georgia TB Research Advancement Center and mentor on D43 and T32 programs, she is well placed to provide outstanding research and training opportunities. Biospecimens, clinical, and epidemiologic data from Dr. Shah’s ongoing NIH R01-funded CONTEXT study provide new opportunities for insights into TB transmission, including the impact of the COVID-19 pandemic on social contact patterns that are a key factor in disease spread. The CONTEXT study will serve as the parent study for the new research proposed in this K24 that will: 1) characterize Mtb genomic relatedness using long-read sequencing and evaluate the impact on transmission networks; and 2) characterize changes in social contact patterns during the COVID-19 pandemic and estimate the impact on TB incidence. Each aim is designed to integrate mentees who have experience and interest in growing their careers in these emerging areas of TB transmission science. Dr. Shah’s research and mentoring program is facilitated by her long-standing, cross-disciplinary collaborations with leading experts in mycobacterial genomics, pharmacology, immunology, clinical trials, and mathematical modeling. In addition, the outstanding training resources, funding opportunities, and research infrastructure at Emory will be integrated into Dr. Shah’s mentoring program to create an environment that enables the success of her trainees to pursue independent, impactful careers in TB, HIV, and global health POR.", "keywords": [ "Affect", "Area", "Base Pairing", "COVID-19", "COVID-19 pandemic", "COVID-19 pandemic effects", "Cause of Death", "Centers for Disease Control and Prevention (U.S.)", "Clinical", "Clinical Data", "Clinical Research", "Clinical Trials", "Clonal Expansion", "Collaborations", "Communicable Diseases", "Communities", "Data", "Diagnosis", "Disease", "Drug resistance in tuberculosis", "Ensure", "Environment", "Epidemic", "Epidemiologist", "Epidemiology", "Extreme drug resistant tuberculosis", "Foundations", "Funding", "Funding Opportunities", "Genomics", "Goals", "HIV", "HIV/TB", "Health", "Health Policy", "Household", "Immunology", "Incidence", "Individual", "Interdisciplinary Study", "International", "K-Series Research Career Programs", "Knowledge", "Lead", "Link", "Location", "M. tuberculosis genome", "Measurement", "Measures", "Mentors", "Mentorship", "Methodology", "Methods", "Mid-Career Clinical Scientist Award (K24)", "Modeling", "Molecular Epidemiology", "Multi-Drug Resistance", "Multidrug-Resistant Tuberculosis", "Mycobacterium tuberculosis", "Parents", "Participant", "Patient Care", "Pattern", "Persons", "Pharmacology", "Physicians", "Policies", "Prevention", "Public Health", "Research", "Research Infrastructure", "Resources", "Rifampicin resistance", "Role", "Science", "Scientific Advances and Accomplishments", "Scientist", "Social Mobility", "South Africa", "Specimen", "Structure", "Time", "Training", "Treatment outcome", "Tuberculosis", "United States National Institutes of Health", "Universities", "Work", "career", "career development", "co-infection", "community setting", "design", "detection limit", "effective intervention", "epidemiologic data", "epidemiology study", "experience", "genome sequencing", "global health", "improved", "innovation", "insight", "interest", "mathematical model", "multidisciplinary", "mycobacterial", "next generation", "novel", "novel diagnostics", "novel therapeutics", "patient oriented", "patient oriented research", "prevent", "programs", "research study", "resistant strain", "skills", "social", "social contact", "success", "training opportunity", "transmission process", "whole genome" ], "approved": true } }, { "type": "Grant", "id": "11775", "attributes": { "award_id": "1R33HL168751-01", "title": "A New Lipid Nanoparticle Technology Enabling Long-acting mRNA Therapy", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Heart Lung and Blood Institute (NHLBI)" ], "program_reference_codes": [], "program_officials": [ { "id": 22565, "first_name": "ILANA GRACE", "last_name": "Goldberg", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-06-15", "end_date": "2025-05-31", "award_amount": 542677, "principal_investigator": { "id": 27651, "first_name": "Jinjun", "last_name": "Shi", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 891, "ror": "https://ror.org/04b6nzv94", "name": "Brigham and Women's Hospital", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "Recent clinical success of mRNA vaccines for COVID-19 has sparked enormous interest in mRNA therapy for a wide range of biomedical applications including protein replacement therapy. However, one unique challenge associated with mRNA therapy is dealing with the transient efficacy due to its relatively short half-life. Current nanoparticles including FDA-approved lipid nanoparticles (LNPs) could significantly improve mRNA translation efficiency, but the duration of in vivo protein expression by these mRNA NPs is generally short (limited to a few days), thus requiring frequent re-dosing. The main objective of this project is to advance a new transformative LNP technology enabling long-acting mRNA replacement therapy of genetic disorders associated with loss of function of a particular protein. In our recent studies, we developed a new generation of LNPs and performed the head-to-head comparison in vitro and in vivo to the benchmark LNP formulations composed of FDA-approved ionizable lipids. We observed a dramatic increase of the duration of model protein expression in vitro and in vivo by our new mRNA LNPs. Preliminary safety studies showed that our mRNA LNPs were well tolerated without observable adverse events in vivo. With the proof-of-concept demonstration of our long-acting mRNA LNPs, this project aims to i) further optimize the mRNA LNP technology for longer-term, high level protein expression, and ii) rigorously validate this transformative mRNA delivery platform using hemophilia A as a model disease. We expect that with successful validation in normal and hemophilia A mice, this long-acting mRNA LNP platform could be readily moved into clinical testing for hemophilia and expanded to other genetic diseases that require restoration of normal protein functions.", "keywords": [ "Address", "Adverse event", "Antibodies", "Apoptosis", "Benchmarking", "Blood", "Blood Chemical Analysis", "Blood Coagulation Disorders", "Blood Coagulation Factor", "Blood coagulation", "COVID-19 vaccine", "Cholesterol", "Clinical", "Clinical Trials", "Coagulation Process", "Dependovirus", "Disease", "Disease model", "Dose", "Eligibility Determination", "Erythropoietin", "F8 gene", "FDA approved", "Factor IX", "Factor VIII", "Formulation", "Galactose", "Generations", "Genes", "Genetic", "Genetic Diseases", "Half-Life", "Heart", "Hematocrit procedure", "Hematology", "Hemophilia A", "Hemophilia B", "Hepatocyte", "Human", "In Vitro", "Injections", "Intravenous infusion procedures", "Ligands", "Lipids", "Lung", "Measures", "Mediating", "Medical", "Messenger RNA", "Modeling", "Monitor", "Mus", "Organ", "Other Genetics", "Patients", "Play", "Population", "Production", "Protein Engineering", "Proteins", "RNA vaccine", "Recombinant Proteins", "Recombinants", "Replacement Therapy", "Safety", "Secondary to", "Stains", "Surface", "Technology", "Testing", "Therapeutic", "Time", "Toxic effect", "Validation", "Work", "biomaterial compatibility", "enzyme replacement therapy", "gene therapy", "head-to-head comparison", "improved", "in vivo", "interest", "interpatient variability", "lipid nanoparticle", "loss of function", "mRNA Expression", "mRNA Translation", "mRNA delivery", "nanoparticle", "protein expression", "protein function", "research clinical testing", "restoration", "safety study", "success" ], "approved": true } }, { "type": "Grant", "id": "11776", "attributes": { "award_id": "1R21AI174080-01A1", "title": "Leveraging Pathogen-Host Networks to Identify Virus-specific and Estradiol-regulated Mechanisms during Respiratory Infection", "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)" ], "program_reference_codes": [], "program_officials": [ { "id": 6243, "first_name": "BROOKE ALLISON", "last_name": "Bozick", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-06-09", "end_date": "2025-05-31", "award_amount": 253510, "principal_investigator": { "id": 27652, "first_name": "Jason Edward", "last_name": "Shoemaker", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 848, "ror": "", "name": "UNIVERSITY OF PITTSBURGH AT PITTSBURGH", "address": "", "city": "", "state": "PA", "zip": "", "country": "United States", "approved": true }, "abstract": "Respiratory viruses, such as influenza and SARS-CoV-2, interact with distinct molecular pathways in human cells to promote virus replication and alter immune activity. When considering patient cohort variability, morbidity and mortality are often higher for women than men for select influenza virus infections, exemplified in the 2009 H1N1 pandemic. Estradiol, a major sex hormone, has been shown to impact virus replication in a sex-specific manner. Yet much remains unknown as to the pathways different viruses engage to promote infection and alter immune activity or what pathways link estradiol activity to virus replication. This research program uses recently developed bioinformatics algorithms and NIAID-supported, published datasets in order to reveal new pathways and molecules involved in infection with influenza viruses and SAR-CoV-2 (Aim 1) and in infection in respiratory cells derived from women and treated with estradiol (Aim 2). More specifically, we will use two dynamic network perturbation algorithms, ProTINA and DeltaNeTS+, to create dynamic mathematical models of intracellular signaling in order to predict important disease modulators. Dynamic network perturbation analysis will be applied to virus-specific, virus-host interaction networks and host gene expression data induced by each virus. For Aim 2, we have identified gene expression data from influenza-infected nasal cells from female donors that are pretreated with estradiol. We will validate ProTINA’s and DeltaNeTS+ ability to identify host factors of virus replication using results from published siRNA- and CRISPR-based screens. After the validation, we will perform an in-depth characterization of the most significant proteins identified in order to generate new hypothesis on the host pathways that are involved in infection with different respiratory viruses or that interact with estradiol during infection.", "keywords": [ "2019-nCoV", "Address", "Adoption", "Affect", "Age Years", "Algorithms", "Automobile Driving", "Binding", "Bioinformatics", "COVID-19", "CRISPR screen", "Cells", "Cessation of life", "Code", "Communicable Diseases", "Communities", "Computer Analysis", "Data", "Data Set", "Development", "Disease", "Drug resistance", "Epidemiology", "Epithelial Cells", "Estradiol", "Female", "Future", "Gene Expression", "Genomics", "Goals", "Gonadal Steroid Hormones", "Hormones", "Hospitalization", "Human", "Immune", "Immune response", "Infection", "Infectious Diseases Research", "Inflammatory", "Inflammatory Response", "Influenza", "Influenza A Virus H1N1 Subtype", "Influenza A Virus H3N2 Subtype", "Integration Host Factors", "Knowledge", "Link", "Mediating", "Molecular", "Morbidity - disease rate", "Nasal Epithelium", "National Institute of Allergy and Infectious Disease", "Natural regeneration", "Nose", "Pathway interactions", "Patients", "Policies", "Process", "Proteins", "Publishing", "Research", "Respiratory Tract Infections", "Signal Transduction", "Small Interfering RNA", "Time", "Validation", "Viral Load result", "Virus", "Virus Replication", "Woman", "Work", "cohort", "drug candidate", "effectiveness evaluation", "experience", "human data", "in silico", "influenza infection", "influenzavirus", "mathematical model", "men", "molecular drug target", "mortality", "novel", "pandemic disease", "pathogen", "patient variability", "pressure", "programs", "respiratory", "respiratory infection virus", "respiratory virus", "response", "seasonal influenza", "secondary analysis", "sex", "therapeutic candidate", "therapeutic target", "therapy development", "virus host interaction", "whole genome", "young adult" ], "approved": true } }, { "type": "Grant", "id": "11777", "attributes": { "award_id": "1R01AI173109-01A1", "title": "Broadly neutralizing SARS-CoV-2 peptidic knobs", "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)" ], "program_reference_codes": [], "program_officials": [ { "id": 6115, "first_name": "DIPANWITA", "last_name": "Basu", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-06-09", "end_date": "2028-05-31", "award_amount": 967225, "principal_investigator": { "id": 27653, "first_name": "Vaughn Vasil", "last_name": "Smider", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2048, "ror": "", "name": "APPLIED BIOMEDICAL SCIENCE INSTITUTE", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "Targeted therapeutic agents range in size from very small organic molecules (100’s of Da) to protein-based molecules like monoclonal antibodies (~150,000 Da). Small disulfide bonded peptides have evolved in many species, including plants and animals, to have ideal pharmacological properties including high affinity target binding, stability to proteases, heat and other stresses. Such peptides include “cyclotides” or “knottins” which can inhibit enzymes, ion channels, and GPCRs with high potency and are often the major active component of venoms of many predator organisms. We have uncovered convergent evolution between ultralong third complementary determining regions (CDR H3s) in the heavy chain of an unusual class of cow antibodies and cyclotide/knottin peptides. We can produce these “knob” peptides in microbial systems and they retain the binding and potency properties of the parent antibody. These tiny peptide-based molecules are small (~4-6 kDa), highly stable, and can bind targets at subnanomolar KD. We have already developed a panel of virus neutralizing knob peptides against SARS-CoV-2 which bind unique epitopes, and some of which maintain high affinity binding to various SARS-CoV-2 variants, including the recent ‘delta’ and ‘omicron’ strains. The high stability, potency, and straightforward manufacturing path enables multiple routes of administration, potentially including inhaled or intranasal delivery, which could be very important prophylactic or treatment in the current or future coronavirus pandemic. Our goals in this project are to further develop the technology to identify peptidic knob domains, expand our panel of knobs against SARS-CoV-2 variants and other coronaviruses like MERS-CoV and SARS-CoV- 1, understand the structural basis of their binding, and validate their activity in vitro and in vivo. The knobs identified here can potentially be used as monotherapy or combination therapy in the current or a new coronavirus pandemic, and will be a valuable new therapeutic class to add to the arsenal against coronavirus disease.", "keywords": [ "2019-nCoV", "Affinity", "Animals", "Antibodies", "Antibody Binding Sites", "Antibody Response", "Antigens", "Antiviral Agents", "Binding", "COVID-19", "COVID-19 outbreak", "COVID-19 pandemic", "Cattle", "Cessation of life", "Clinical", "Combined Modality Therapy", "Coronavirus", "Coronavirus spike protein", "Disease", "Disease Outbreaks", "Disease model", "Distant", "Disulfides", "Electron Microscopy", "Enzyme Inhibition", "Epitopes", "Escherichia coli", "Evolution", "Fab Immunoglobulins", "Future", "G-Protein-Coupled Receptors", "Genetic Variation", "Goals", "HIV", "Human", "Immunity", "Immunize", "In Vitro", "Infection", "Inhalation", "Ion Channel", "Length", "Libraries", "Light", "Lung diseases", "Middle East Respiratory Syndrome", "Middle East Respiratory Syndrome Coronavirus", "Molecular", "Molecular Evolution", "Monoclonal Antibodies", "Organism", "Parents", "Passive Immunotherapy", "Patients", "Pattern", "Peptide Hydrolases", "Peptides", "Plants", "Production", "Property", "Prophylactic treatment", "Proteins", "Resistance", "Respiratory Disease", "Risk", "Rodent Diseases", "Route", "SARS coronavirus", "SARS-CoV-2 variant", "Serum", "Severe Acute Respiratory Syndrome", "Stress", "System", "Techniques", "Technology", "Therapeutic", "Therapeutic Monoclonal Antibodies", "Variant", "Venoms", "Viral", "Viral Physiology", "Virus", "Work", "X-Ray Crystallography", "coronavirus disease", "cross reactivity", "disulfide bond", "future pandemic", "glycosylation", "in vitro activity", "in vivo", "inhibitor", "microbial", "nanomolar", "neutralizing antibody", "novel", "novel coronavirus", "novel drug class", "novel therapeutics", "pandemic coronavirus", "pandemic disease", "pharmacologic", "prophylactic", "severe COVID-19", "small molecule", "targeted treatment", "therapeutic development", "tool", "transmission process", "variants of concern" ], "approved": true } }, { "type": "Grant", "id": "11778", "attributes": { "award_id": "1F31HL165733-01A1", "title": "A Neural Control Circuit for Coughing", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Heart Lung and Blood Institute (NHLBI)" ], "program_reference_codes": [], "program_officials": [ { "id": 27654, "first_name": "Lawrence", "last_name": "Baizer", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-05-08", "end_date": "2024-10-07", "award_amount": 40418, "principal_investigator": { "id": 27655, "first_name": "Noam", "last_name": "Gannot", "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": "PROPOSAL SUMMARY Coughing is an important respiratory function that protects the airways and the lungs. The cough reflex can be activated by inhaled particles, pathogens, irritants, or having a lung disease such as asthma or COVID- 19. The brain controls coughing by expelling air from the respiratory system to clear these accumulated secretions. Coughing often becomes excessive with severe consequences under pathological conditions, resorting people to seek medical attention. Effective anti-tussive medications are lacking due to the limited knowledge on the neural circuit controlling cough. In our lab, we recently developed a mouse model to study the neural pathways for coughing with the genetic and neurogenetic tools available in mice. We identified a sub-population of neurons within the nucleus tractus solitarius (NTS) that express the neuropeptide gene tachykinin 1 (Tac1) that are activated during tussive challenges. Photoactivation of these neurons is sufficient in inducing coughing, while genetic ablation or chemogenetic silencing of these neurons diminishes the coughs induced by tussive agents. These results reveal the first genetically defined neurons in the brain that mediate coughing induced by tussive agents. Based on these preliminary results, we hypothesize that the NTS Tac1 neurons are the key cough control center that are activated by the tussive challenge and integrate the downstream targets in the brain to induce coughing through the SP-NK1R pathway. Two aims are proposed: (1) investigate the neural dynamics and molecular pathway underlying how NTS Tac1 neurons respond to coughing (2) identify the downstream cough circuit of the NTS Tac1 neurons. These studies will be accomplished by integrating activity recording, pharmacology, circuit tracing, and optogenetics to trace the neural dynamics, the molecular pathways, and the downstream circuits of the NTS Tac1 neurons in coughing. To understand how these neurons are modulated in pathological conditions, I will examine their real-time activation during a tussive challenge and define their molecular pathway. To identify the cough circuit, I will identify the downstream regions of NTS Tac1 neurons and conduct a functional study on these projections. The successful completion of this project will advance the knowledge of the endogenous central neural circuit and pathway underlying cough. Furthermore, it will lead to the potential identification of drug targets for manipulating cough, thereby providing new opportunities for the development of novel therapeutics and better treatments for those suffering from excessive coughing.", "keywords": [ "Ablation", "Air", "Animals", "Antitussive Agents", "Asthma", "Brain", "Brain Stem", "COVID-19", "Cavia", "Cell Nucleus", "Chronic", "Complex", "Coughing", "Defense Mechanisms", "Development", "Drug Targeting", "Dust", "Event", "Fiber", "Foundations", "Genetic", "Germ", "Goals", "Inhalation", "Irritants", "Knowledge", "Life", "Lung", "Lung diseases", "Maps", "Mediating", "Medical", "Modeling", "Molecular", "Molecular Target", "Motor Neurons", "Motor output", "Mucous body substance", "Mus", "Nerve", "Neural Pathways", "Neurons", "Neuropeptide Gene", "Pathologic", "Pathway interactions", "Patients", "Persons", "Pharmaceutical Preparations", "Pharmacology", "Pharyngeal structure", "Phase", "Photometry", "Physiological", "Placebos", "Play", "Population", "Prevalence", "Reflex action", "Resort", "Respiration", "Respiratory Disease", "Respiratory System", "Respiratory physiology", "Role", "Signal Transduction", "System", "TACR1 gene", "Tachykinin", "Testing", "Therapeutic", "Time", "antagonist", "calcium indicator", "central pattern generator", "common symptom", "design", "guinea pig model", "in vivo", "medical attention", "mind control", "mouse model", "neural", "neural circuit", "neurogenetics", "neuroregulation", "novel therapeutics", "optogenetics", "particle", "pathogen", "pharmacologic", "photoactivation", "postsynaptic", "response", "success", "tool" ], "approved": true } }, { "type": "Grant", "id": "11779", "attributes": { "award_id": "1I01BX006010-01A1", "title": "Vaccinating at Mucosal Surfaces with Nanoparticle-conjugated Antigen and Adjuvant", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2023-04-01", "end_date": "2027-03-31", "award_amount": null, "principal_investigator": { "id": 27656, "first_name": "SEBASTIAN", "last_name": "JOYCE", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1477, "ror": "https://ror.org/05eq41471", "name": "Veterans Health Administration", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true }, "abstract": "The incidence of tuberculosis (TB) has increased among Veterans in recent years because global TB burden has escalated with the emergence of multidrug-resistant and extremely drug resistant Mycobacterium tuberculosis (Mtb) strains. Further, current vaccines do not elicit long-lasting protective immunity against TB, especially in adults. Hence, this application addresses a critical unmet need for an effective vaccine against TB and thereby, significantly improve the quality of life of our Veterans. Herein, we propose pre-clinical studies that will identify protective CD8+ T cell epitopes and develop intranasal vaccine delivery platforms for the design of next generation TB vaccines. The global burden of TB caused by Mycobacterium tuberculosis (Mtb) infection is enormous. A third of the world’s population is currently infected with Mtb, an airborne pathogen that causes ~1.5 million deaths annually. The escalating emergence of multidrug-resistant and extremely drug resistant Mtb strains for which treatment options are costly and limited, further exacerbates global burden. This problem persists because current vaccines do not elicit long-lasting protective immunity against TB, especially in adults. The challenge is multifaceted because Mtb enters the host through the respiratory tract and, therefore, optimal protection will require installation of lung-resident CD4+ and CD8+ memory T cells positioned at the frontline to respond immediately to an infection. Traditional vaccines and approved adjuvants typically elicit weak, short- lived T cell responses, and parenteral vaccination is ineffective at installing protective immunity within the mucosae. Moreover, most virus-vectored and subunit TB vaccines employ a small subset of Mtb antigens, resulting in insufficient epitope diversity for optimal protection, partly because the epitopes that are presented during Mtb infection and confer protective immunity are not fully defined. Hence, our overall objective is to discover immunogenic, protective Mtb epitopes and to incorporate them in an innovative nanoparticle (NP)- based intranasal vaccine designed to promote a balanced CD4+ and CD8+ T cell responses in the lungs that are protective against TB. As a means to accomplish this goal, we discovered >10,000 peptides that bind to HLA- A*02:01, B*07:02, B*35:01, & B*35:03 in a high-throughput binding assay using ultrahigh-density peptide arrays. Now the challenge is to identify epitopes recognised by Mtb-reactive CD8+ T cells that can protect against infection in a preclinical, humanised HLA-Itg mouse models. Moreover, using different infection models, we have developed multiple nanoparticle platforms for simultaneous delivery of antigens and adjuvants that efficiently generate protective, tissue resident CD8+ T cells (Trm). Guided by these exciting published and preliminary results, we will test this central hypothesis: Intranasal immunization with subunit vaccines consisting of novel Mtb antigens and adjuvant will generate CD8+ Trm responses in the lungs. Installation of Mtb-reactive CD8+ Trm at the port of pathogen entry will protect against a lethal, aerosol challenge of three novel humanised mouse models with [there] clinical isolate of virulent Mtb, [including] HN878. Our strategy to test this hypothesis is to, (a) define immunodominant CD8+ T cell epitopes presented by HLA-B*07:02 that protect B7.2tg mice from Mtb infections; and (b) define common immunodominant CD8+ T cell epitopes presented by multiple B*07:02-related alleles [called B7 supertype] that protect HLA-I transgenic mouse models from Mtb infections. Our multidisciplinary team —consisting of biochemists, immunologists, microbiologists, and bioengineer, is ideally situated to pursue the stated Specific Aims. We anticipate that successful completion of the proposed research will inform next generation vaccine design against Mtb infections and TB disease. Our innovative “discover and deliver” approach to vaccine design will impact clinical practice paradigms against TB and other pulmonary infectious diseases such as SARS-COVID19 and Flu. Thereby, vaccine paradigms emerging from our research bears with it the promise to significantly improve the quality of life of our Veterans.", "keywords": [ "Academic Medical Centers", "Address", "Adjuvant", "Adult", "Aerosols", "Alleles", "Antigen Presentation Pathway", "Antigens", "Bacteria", "Binding", "Biological Assay", "Biomedical Engineering", "CD8-Positive T-Lymphocytes", "CD8B1 gene", "COVID-19", "Cells", "Cellular biology", "Cessation of life", "Chronic", "Clinical", "Common Epitope", "Communicable Diseases", "Disease", "Drug resistant Mycobacteria Tuberculosis", "Effector Cell", "Epitopes", "Generations", "Goals", "HLA-A gene", "HLA-B Antigens", "Human", "Immune", "Immunity", "Immunization", "Immunodominant Epitopes", "Immunologist", "Incidence", "Infection", "Lung", "Modeling", "Morbidity - disease rate", "Mucous Membrane", "Multi-Drug Resistance", "Mus", "Mycobacterium tuberculosis", "Mycobacterium tuberculosis antigens", "Peptides", "Population", "Positioning Attribute", "Pre-Clinical Model", "Predisposition", "Publishing", "Quality of life", "Research", "Respiratory System", "Route", "Severe Acute Respiratory Syndrome", "Site", "Subunit Vaccines", "Surface", "T cell response", "T memory cell", "T-Lymphocyte Epitopes", "Testing", "Tissues", "Transgenic Mice", "Transgenic Organisms", "Tuberculosis", "Tuberculosis Vaccines", "Vaccinated", "Vaccination", "Vaccine Design", "Vaccines", "Veterans", "Virulent", "Virus", "Work", "clinical practice", "cost", "density", "design", "flu", "high throughput screening", "humanized mouse", "immunogenic", "improved", "in vivo", "innovation", "mortality", "mouse model", "multidisciplinary", "nanoparticle", "next generation", "novel", "novel vaccines", "pathogen", "pre-clinical", "preclinical study", "response", "transmission process", "vaccine delivery", "vector" ], "approved": true } }, { "type": "Grant", "id": "11780", "attributes": { "award_id": "1F31HD111277-01", "title": "Protocols to ascertain adverse events after telehealth sexual and reproductive health services", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)" ], "program_reference_codes": [], "program_officials": [ { "id": 24440, "first_name": "Ronna", "last_name": "Popkin", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-04-01", "end_date": "2026-03-31", "award_amount": 42670, "principal_investigator": { "id": 27657, "first_name": "Leah Ren-Ai", "last_name": "Koenig", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 768, "ror": "https://ror.org/043mz5j54", "name": "University of California, San Francisco", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "This mentored Ruth L. Kirschstein National Research Service Award will provide the trainee, a PhD student in epidemiology at UCSF, with the training necessary to become a researcher in sexual and reproductive health. Her training goals for this fellowship are to gain expertise in health services research, bias analyses, and methods to address missing data under the guidance of a team of expert mentors. This fellowship will provide the applicant with the skills, content knowledge, and practical experience to launch an independent research career focused on the evaluation of service delivery innovations in sexual and reproductive health. Telehealth became a prominent method of sexual and reproductive health service delivery during the COVID- 19 pandemic. In telehealth services, patients are typically screened remotely, dispensed any medications by mail, and followed subsequently to monitor for the occurrence of adverse events. Some research suggests that telehealth patients may be less likely than those who receive in-person services to follow up with the telehealth provider after medications are dispensed, and the outcomes of patients who do not complete follow-up are not understood. The goal of this research is to evaluate the performance of telehealth protocols at identifying adverse events. Building on the applicant’s prior work and current research position, this F-31 will involve secondary analyses of data from a cohort study of patients who received telehealth sexual and reproductive health services, to (Aim 1) estimate the incidence of adverse events among patients who do not return for follow-up and (Aim 2) assess the timing and process of adverse events diagnoses after telehealth sexual and reproductive health services. This evidence will allow telehealth sexual and reproductive health providers to understand the risk of adverse events among their patients who do not return for follow-up and whether their current follow-up protocols are optimal for the identification of adverse events. Knowledge gained from this research will advance NICHD’s mission to ensure individuals are born healthy and wanted and that women are not harmed by reproductive processes. The major strengths of this proposal are that it: (1) relies on a large existing prospective dataset of US telehealth sexual and reproductive health patients, with which the applicant already has experience; (2) uses rigorous methods for evaluating bias and addressing missing data; and (3) tests clinically impactful hypotheses focusing on the timely and growing field of telehealth for sexual and reproductive health. The proposed research and training will prepare the applicant for her future career as an independent researcher focused on service delivery innovations in sexual and reproductive health care.", "keywords": [ "Address", "Adverse event", "Blood Transfusion", "COVID-19 pandemic", "California", "Caring", "Childbirth", "Clinical", "Clinical Protocols", "Clinical Services", "Cohort Studies", "Contraceptive methods", "Cost Savings", "Data", "Data Analyses", "Data Collection", "Data Set", "Data Sources", "Development", "Diagnosis", "Doctor of Philosophy", "Electronic Health Record", "Ensure", "Epidemiology", "Evaluation", "Event", "Fellowship", "Foundations", "Future", "Goals", "Health", "Health Personnel", "Health Services", "Health Services Research", "Health Surveys", "Health system", "Healthcare", "Home", "Hospitalization", "Incidence", "Incomplete spontaneous abortion", "Individual", "Knowledge", "Mentors", "Methodology", "Methods", "Mission", "Monitor", "National Institute of Child Health and Human Development", "National Research Service Awards", "Outcome", "Participant", "Patient Outcomes Assessments", "Patient Participation", "Patient-Centered Care", "Patient-Focused Outcomes", "Patients", "Performance", "Persons", "Pharmaceutical Preparations", "Positioning Attribute", "Pregnancy", "Probability", "Process", "Proliferating", "Protocols documentation", "Provider", "Reproductive Health", "Reproductive Health Services", "Reproductive Process", "Research", "Research Personnel", "Role", "Safety", "Schedule", "Sepsis", "Services", "Sexual Health", "Sexually Transmitted Diseases", "Statistical Methods", "Surveys", "Testing", "Time", "Training", "United Kingdom", "United States", "United States Food and Drug Administration", "Woman", "Work", "abortion", "adverse event monitoring", "adverse event risk", "career", "cost effective", "cost effectiveness", "data management", "design", "doctoral student", "efficacy study", "experience", "follow-up", "health care delivery", "improved", "innovation", "insight", "patient oriented", "patient safety", "patient screening", "patient subsets", "prospective", "remote screening", "reproductive", "safety study", "secondary analysis", "service delivery", "skills", "telehealth" ], "approved": true } } ], "meta": { "pagination": { "page": 1383, "pages": 1419, "count": 14184 } } }