Grant List
Represents Grant table in the DB
GET /v1/grants?sort=-other_investigators
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-other_investigators", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1405&sort=-other_investigators", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=2&sort=-other_investigators", "prev": null }, "data": [ { "type": "Grant", "id": "15803", "attributes": { "award_id": "1I01HX003797-01A3", "title": "Evaluating Veterans' Reproductive Healthcare Access, Quality and Outcomes in a Changing Landscape (EVOLVE)", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2025-07-01", "end_date": "2029-06-30", "award_amount": null, "principal_investigator": { "id": 32893, "first_name": "Lisa Susanne", "last_name": "Callegari", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 32894, "first_name": "Deirdre A", "last_name": "Quinn", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2660, "ror": "", "name": "VA PUGET SOUND HEALTHCARE SYSTEM", "address": "", "city": "", "state": "WA", "zip": "", "country": "United States", "approved": true }, "abstract": "Background: Recent years have witnessed unprecedented changes in the reproductive healthcare landscape in the US, including heightened awareness of reproductive health inequities following the 2020 nationwide racial justice reckoning, barriers to access resulting from the COVID-19 pandemic, and the proliferation of state abortion restrictions and bans following the 2022 Dobbs v Jackson Supreme Court decision. Today, access to high-quality, equitable contraceptive care has never been more vital for Veterans, who face elevated risks of poor outcomes from unintended pregnancy due to high rates of health comorbidities and psychosocial risks. The Examining Contraceptive Use and Unmet Need in Veterans (ECUUN) survey fielded in 2014-16 by study team members demonstrated high rates of unintended pregnancy and gaps in VA contraceptive access and quality, with significant disparities among Black and Latinx Veterans. While the ECUUN study helped inform VA’s reproductive health policies to date, updated data are urgently needed to capture VA’s progress in addressing disparities over time as well as its ability to meet Veterans’ needs in today’s shifted landscape. Significance: This study will generate timely quantitative and qualitative data necessary for VA as a learning health system to address gaps in access and quality and to adapt its policies and programming to meet Veterans’ changing needs. In addition, this study focuses on contraceptive counseling experiences in marginalized Veterans, for whom this care may be fraught due to the US history of reproductive oppression such as forced sterilization and policies to punish or limit reproduction in racial minority and low-income people. Findings will enable VA to respond to new White House and congressional directives related to women’s health that call for research to advance reproductive healthcare access and reduce disparities in care. Innovation & Impact: This proposal is innovative in its timeliness, use of prior data to draw novel comparisons over time, deployment of new state-of-the-art person-centered measures not yet fielded in VA such as the National Quality Forum (NQF)-endorsed Person-Centered Contraceptive Counseling (PCCC) measure, and collection of data to capture experiences of VA’s new policy to provide abortion care in select cases. Specific Aims: Aim 1: To use quantitative survey data to examine changes over time since ECUUN in contraceptive use, unintended pregnancy, and abortion, including differences by Veteran characteristics (e.g., race/ethnicity, geography). Aim 2: To use quantitative survey data to test for current disparities in novel person-centered measures (e.g., PCCC) by Veteran characteristics and characteristics of their health care. Aim 3: To contextualize Aim 1 & 2 findings, including disparities in experiences of contraceptive care and unintended pregnancy/abortion, by conducting qualitative interviews with Veterans. Methodology: This is a sequential explanatory mixed methods study beginning with a national survey of 3,600 pregnancy-capable reproductive-age Veterans who used VA primary or gynecology care in the past year. Qualitative interviews will then be conducted among Veteran survey respondents, purposively sampling at-risk subgroups (Black, Latinx, rural, residence in abortion-restrictive state) whose survey responses indicate gaps in care quality or equity. Quantitative data will inform qualitative sampling and data collection, and quantitative and qualitative data will be integrated using mixed methods analytic techniques including joint displays. Next Steps/Implementation: Next steps will include conducting a stakeholder engagement meeting with Veterans, women’s health providers, and operational partners from the Offices of Women’s Health, Health Equity, and Rural Health to share key research findings, develop strategic goals, and prioritize interventions to address disparities in contraceptive access and quality. Ultimately, this study has the potential to enhance VA’s ability to be a national leader in delivering high-quality and person-centered reproductive healthcare and to inform efforts to advance quality and equity in reproductive healthcare both within and beyond the VA.", "keywords": [ "Address", "Awareness", "Black race", "COVID-19 pandemic", "Caring", "Characteristics", "Clinic", "Clinical", "Coercion", "Collaborations", "Congresses", "Constitution", "Contraceptive Agents", "Contraceptive Usage", "Contraceptive methods", "Counseling", "Data", "Data Collection", "Development", "Disparity", "Equity", "Ethnic Origin", "Exclusion", "Female", "Geography", "Goals", "Gynecology", "Health", "Health Care", "Health Personnel", "Health Policy", "Health system", "Individual", "Intention", "Intervention", "Interview", "Investments", "Involuntary Sterilization", "Joints", "Judgment", "Justice", "Latina", "Latinx", "Lead", "Learning", "Low Income Population", "Low income", "Measures", "Medical", "Medical Records", "Mental Health", "Methodology", "Methods", "Mission", "Movement", "Outcome", "Personal Satisfaction", "Persons", "Policies", "Populations at Risk", "Pregnancy", "Proliferating", "Provider", "Punishment", "Quality of Care", "Race", "Recording of previous events", "Reproduction", "Reproductive Health", "Reproductive History", "Research", "Respondent", "Risk", "Rural", "Rural Health", "Sampling", "Services", "Subgroup", "Supreme Court Decisions", "Surveys", "Techniques", "Testing", "Time", "Trust", "United States Department of Veterans Affairs", "Update", "Veterans", "Voice", "Women's Health", "abortion", "access disparities", "analytical method", "comorbidity", "disparity reduction", "experience", "field survey", "gaps in access", "gender minority group", "health care availability", "health care disparity", "health care settings", "health equity", "health inequalities", "innovation", "marginalization", "marginalized population", "medical vulnerability", "meetings", "member", "novel", "patient oriented", "people of color", "person centered", "preference", "pregnancy related death", "prevent", "primary care provider", "psychosocial", "racial disparity", "racial minority", "reproductive", "reproductive age", "residence", "response", "rural area", "rurality", "sample collection", "sexual minority group", "sexual trauma", "social", "unintended pregnancy" ], "approved": true } }, { "type": "Grant", "id": "15799", "attributes": { "award_id": "1R43CA298267-01A1", "title": "Ultra-precision diagnostics for ALK+ non-small cell lung cancer", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Cancer Institute (NCI)" ], "program_reference_codes": [], "program_officials": [ { "id": 32888, "first_name": "SWAMY KRISHNA", "last_name": "TRIPURANI", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-07-09", "end_date": "2026-06-30", "award_amount": 399153, "principal_investigator": { "id": 32889, "first_name": "David Randall", "last_name": "Armant", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 32890, "first_name": "Rodrigo C", "last_name": "Fernandez-Valdivia", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2658, "ror": "", "name": "ALELOPHARMA INC.", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true }, "abstract": "Background & Significance: Identifying ALK-positive lesions, which are highly responsive to treatment with Crizotinib or Alectinib, is a high-priority for managing patients with ALK+ Non-Small Cell Lung Cancer (NSCLC). A blood-based companion diagnostic (liquid biopsy) could monitor NSCLC patients post-treatment for tumor recurrence without tissue re-biopsy, and also identify non-symptomatic ALK+ individuals for earlier, more effective treatment with ALK kinase inhibitors. Expansion of this approach to other major oncogenic mutations has potential as a non-invasive cancer screening tool that would be transformative for healthcare. Objective & Innovation: AleloPharma Inc. is achieving solutions for personalized precision medicine using AleloMAX, an innnovative high-dimensional molecular detection system that allows ultra-specific detection of target nucleic acids with an impressive 1-absolute copy per reacting assay limit-of-detection (LOD) that effectively eliminates both false positives and false negatives. We aim to offer clinicians a cutting-edge diagnostic capable of accurately detecting ALK translocations among cell-free RNA in the blood plasma of affected patients. Approach: A proof-of-principle study, supported by preliminary LOD data obtained with synthetic ALK constructs, is proposed to develop a liquid biopsy test to detect ALK translocation variants in a kit for use in clinical labs. • Specific Aim 1: Develop an ultra-specific and ultra-sensitive molecular detection platform for EML4-ALK gene fusion translocations in ALK+ NSCLC. We will probe EML4-ALK fusion RNAs using synthetic, in vitro-transcribed mRNAs encompassing the distinct EML4-ALK oncogenic variants. • Specific Aim 2: Demonstrate AleloMAX-ALK’s superior resolution power in ultra-specific molecular probing and limit-of-detection (LOD) analysis in a clinical proof-of-principle study. The EML4-ALK diagnostic platform will be tested using plasma- and/or blood-derived nucleic acid samples obtained from ALK+ NSCLC patients, ALK- NSCLC patients, and healthy control volunteers. Team & Commercialization: Led by a distinguished team with a track record of groundbreaking research in molecular pharmacology, oncology and cellular biology, we are uniquely positioned to tackle this challenge. Our clear roadmap includes patenting all IP and aspires to launch a diagnostic that will have significant clinical utility. Feasibility & Impact: The assay is expected to detect low levels of EML4-ALK mutations in blood of individuals with ALK+ NSCLC. AleloMAX demonstrated diagnostic superiority in prior studies of the NSCLC biomarker POGLUT-1, SARS-CoV-2 and RSV with impressive results. Assay parameters established in this project will be developed as a kit for use in a Phase II study to establish its clinical utility as a companion diagnostic for NSCLC. Successful development of an ALK+ cancer diagnostic will be expanded to include assays for RET, ROS1 and other onco-mutations with additional AleloMAX liquid biopsy assays to monitor a broader panel of cancers. Conclusion: Combining innovation and tangible clinical benefit, our initiative represents a transformative shift in early detection and management of cancer that will positively impact patient survival.", "keywords": [ "2019-nCoV", "ALK gene", "Acceleration", "Address", "Affect", "Aftercare", "Algorithms", "Archives", "Award", "Biological Assay", "Biopsy", "Blood", "Businesses", "COVID-19 diagnosis", "Cancer Detection", "Cancer Diagnostics", "Cancer Patient", "Cells", "Cellular biology", "Chemistry", "Chromosomal translocation", "Clinical", "DNA Sequence Alteration", "Data", "Detection", "Development", "Diagnosis", "Diagnostic", "Diagnostic tests", "Disease", "Early Diagnosis", "Evaluation", "Event", "Fluorescent in Situ Hybridization", "Future", "Gene Amplification", "Gene Fusion", "Genetic Transcription", "Health Care", "Image", "In Vitro", "Individual", "Industry", "Legal patent", "Lesion", "Malignant Neoplasms", "Malignant neoplasm of lung", "Marketing", "Methods", "Molecular", "Molecular Genetics", "Molecular Probes", "Monitor", "Mutation", "Neoplasms", "Non-Small-Cell Lung Carcinoma", "Nucleic Acids", "Oncogenes", "Oncogenic", "Oncology", "Patient Monitoring", "Patients", "Performance", "Pharmacology", "Phase", "Plasma", "Positioning Attribute", "Probability", "Procedures", "Process", "Prognosis", "Protein Tyrosine Kinase", "RNA", "ROS1 gene", "Reaction", "Recurrent tumor", "Research", "Resolution", "Sampling", "Screening for cancer", "Screening procedure", "Sensitivity and Specificity", "Series", "Signal Transduction", "Specificity", "Techniques", "Technology", "Testing", "Therapeutic", "Therapeutic Intervention", "Time", "Tissues", "Transcript", "Tube", "Tyrosine Kinase Inhibitor", "Variant", "Vision", "Work", "biobank", "cancer biomarkers", "cancer diagnosis", "chromosome fusion", "cohort", "commercialization", "companion diagnostics", "comparative", "crizotinib", "detection assay", "detection limit", "detection platform", "diagnostic platform", "diagnostic technologies", "diagnostic tool", "diagnostic value", "early screening", "effective intervention", "effective therapy", "genetic diagnostics", "high dimensionality", "improved", "inhibitor", "innovation", "kinase inhibitor", "liquid biopsy", "molecular diagnostics", "next generation", "next generation sequencing", "novel", "overexpression", "patient screening", "personalized diagnostics", "phase 2 study", "precision medicine", "screening", "sensor technology", "success", "tumor", "validation studies", "volunteer" ], "approved": true } }, { "type": "Grant", "id": "15792", "attributes": { "award_id": "1R21AI193885-01", "title": "UTS-1401 as a Medical Countermeasure to H-ARS Consequent to a Radiation Mass Casualty", "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": 32879, "first_name": "LANYN P", "last_name": "TALIAFERRO", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-08-18", "end_date": "2027-07-31", "award_amount": 157000, "principal_investigator": { "id": 32877, "first_name": "Stephen L", "last_name": "Brown", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 32878, "first_name": "FREDERICK Augustus", "last_name": "VALERIOTE", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2633, "ror": "", "name": "HENRY FORD HEALTH + MICHIGAN STATE UNIVERSITY HEALTH SCIENCES", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true }, "abstract": "Abstract: Our long term objective is to develop a new class of radiation mitigating agents with attractive chemical, physical and biological characteristics required to be an effective drug that can be distributed widely. We have identified a small molecule, UTS-1401 [5-(methylthiomethyl) isoxazole-3-carboxylic acid] which demonstrates mitigation of hematopoietic stem cell death when administered at either 24h or 48h following whole body irradiation (WBI). Using the endogenous spleen colony assay, we demonstrated a mitigating effect in that the colony number with and without UTS-1401 was 3.5 ± 0.4 for a 24h interval and 2.3 ± 0.5 for a 48h interval. We have recently demonstrated a significant radioprotection for both mouse survival and hematopoietic stem cells for this compound when administered up to 72h before irradiation (Valeriote et al, Radiation Research, 202:16- 25, 2024). In this application, we propose to further examine solely the mitigating effect on the hematopoietic acute radiation syndrome (H-ARS) using survival as the endpoint in specific aim 1. Groups of Swiss mice will receive a series of graded doses of WBI (in 0.5 Gy increments) around the LD50 for this syndrome (approximately 7.5 Gy in females and 8.5 Gy in males) with and without the administration of 150 mg/kg UTS-1401. The single dose of UTS-1401 being used in all studies is the highest dose administrable due to its aqueous solubility (in tartrate buffered saline). The radiation mitigation factors will be calculated as the ratio of the LD50 for radiation plus UTS-1401 versus that for radiation alone. The degree of mitigation will be examined at 24, 48 and 72 h following WBI to determine the radiation mitigation fraction as a function of time after radiation exposure. Three routes of drug delivery, intravenous (iv), oral, and subcutaneous (sc), will be examined and compared. Radiation will be delivered by 16 MeV electrons from a Linac. In specific aim 2, we will examine the pharmacokinetics (PK) for 150 mg/kg UTS-1401 comparing the iv, oral, and sc routes to obtain a determination of both the drug kinetics and bioavailability. The AUC values will be correlated with the extent of mitigation. For both specific aims, both male and female mice will be separately studied. The results from these studies are expected to demonstrate an effective first-in-class compound, UTS-1401, which has a small molecular weight, is chemically stable, nontoxic, aqueous soluble and inexpensive with H-ARS radiation mitigating properties which extend for a number of days following WBI. The mechanism studies (not proposed here) are expected to demonstrate UTS- 1401 as a new class of agents for mitigating the cytokine storm consequent to the irradiation.", "keywords": [ "Accidents", "Acute", "Address", "Animal Model", "Animals", "Biologic Characteristic", "Biological", "Biological Assay", "Biological Availability", "Biotechnology", "Blood", "Bone Marrow", "Buffers", "Carboxylic Acids", "Cell Death", "Cells", "Chemicals", "Chernobyl Nuclear Accident", "China", "Clinical", "Conflict (Psychology)", "Cyclic GMP", "Data", "Development", "Dose", "Drug Delivery Systems", "Drug Kinetics", "Drug Stability", "Electromagnetics", "Electrons", "Employee", "Equipment and supply inventories", "Exposure to", "FDA approved", "Federal Government", "Female", "Fibrosis", "Follow-Up Studies", "Formulation", "Fukushima", "Geographic Distribution", "Goals", "Growth Factor", "Hematopoietic", "Hematopoietic System", "Hematopoietic stem cells", "Hospitals", "Individual", "Industry", "Inflammation", "Inflammatory", "Injury", "International", "Intervention", "Intravenous", "Ionizing radiation", "Iran", "Isoxazoles", "Israel", "Korea", "Lethal Dose 50", "Location", "Molecular Weight", "Mus", "North Korea", "Nuclear", "Nuclear Accidents", "Nuclear Weapon", "Oral", "Oral Administration", "Organ", "Pharmaceutical Preparations", "Pharmacologic Substance", "Pharmacology and Toxicology", "Phase", "Phase I Clinical Trials", "Physiologic pulse", "Procedures", "Process", "Property", "Radiation", "Radiation Accidents", "Radiation Protection", "Radiation Toxicity", "Radiation exposure", "Refrigeration", "Research", "Rotation", "Route", "Russia", "Saline", "Schedule", "Series", "Solubility", "South Korea", "Spleen", "Swiss Mice", "Syndrome", "System", "Taiwan", "Tartrates", "Temperature", "Terrorism", "Time", "Tissues", "Ukraine", "United States National Aeronautics and Space Administration", "Vomiting", "War", "Whole-Body Irradiation", "Work", "aqueous", "chemical stability", "cost effective", "cytokine", "cytokine release syndrome", "design", "drug development", "efficacy study", "expiration", "irradiation", "male", "manufacture", "mass casualty", "medical countermeasure", "novel", "product development", "radiation countermeasure", "radiation mitigation", "radiation response", "radioprotected", "research study", "safety study", "scale up", "small molecule", "subcutaneous", "success" ], "approved": true } }, { "type": "Grant", "id": "15791", "attributes": { "award_id": "1R21AI186055-01A1", "title": "UTS-1401: A Novel Mitigator of Radiation Injury", "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": 32876, "first_name": "ANDREA L", "last_name": "DICARLO-COHEN", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-08-01", "end_date": "2027-07-31", "award_amount": 431750, "principal_investigator": { "id": 32877, "first_name": "Stephen L", "last_name": "Brown", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 32878, "first_name": "FREDERICK Augustus", "last_name": "VALERIOTE", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2633, "ror": "", "name": "HENRY FORD HEALTH + MICHIGAN STATE UNIVERSITY HEALTH SCIENCES", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true }, "abstract": "Abstract: Our long term objective is to develop a new class of radiation mitigating agents with attractive chemical, physical and biological characteristics required to be an effective drug that can be distributed widely. We have identified a small molecule, UTS-1401 [5-(methylthiomethyl) isoxazole-3-carboxylic acid] which demonstrates mitigation of hematopoietic stem cell death when administered at either 24h or 48h following whole body irradiation (WBI). Using the endogenous spleen colony assay we demonstrated a significant mitigating effect (ratio of colony number with and without UTS-1401) when drug was given 24h or 48h after radiation. We have also recently demonstrated a significant radioprotection for both mouse survival and hematopoietic stem cells for this compound for up to 72h before irradiation (Valeriote et al, Radiation Research, 202:16-25, 2024). In this application, we propose to examine solely the mitigating effect to both the hematopoietic acute radiation syndrome (H-ARS) in specific aim 1 and the gastrointestinal acute radiation syndrome (GI-ARS) in specific aim 2 following WBI (with 5% bone marrow protection for specific aim 2). Swiss mice will receive a series of graded doses of WBI around the LD50 for both syndromes with and without the administration of 150 mg/kg UTS- 1401. The single dose of UTS-1401 being used in all studies is the highest dose administrable due to its aqueous solubility (in tartrate buffered saline). The radiation mitigation factors will be calculated as the ratio of the LD50 for radiation plus UTS-1401 versus radiation alone. The degree of mitigation will be examined at 24, 48 and 72 h following WBI to determine the timeframe of mitigation after radiation exposure. Three routes of drug delivery, intravenous (iv), oral, and subcutaneous (sc), will be examined and compared. For all specific aims, both male and female mice will be separately studied. Radiation will be delivered by electrons from a Linac. In specific aim 3, we will examine the pharmacokinetics (PK) for 150 mg/kg UTS-1401 comparing the iv, oral, and sc routes to obtain a determination of both the drug kinetics and bioavailability. The AUC values will be correlated with the extent of mitigation. Finally, in specific aim 4, we will address the mechanism of action with studies focused on the role of specific cytokines induced by radiation in the so-called “cytokine storm”. We will assess the time course changes of TNF-α, IL-1β, IL-6, CSF and TGF-β in blood as well as bone marrow and intestinal mucosa over 20 days following: UTS-1401 alone, 10 Gy irradiation, and the combination of UTS-1401 and radiation at a 24h interval. The results from these studies are expected to demonstrate an effective first-in-class compound, UTS-1401, which has a small molecular weight, is chemically stable, nontoxic, aqueous soluble and inexpensive with radiation mitigating properties which extend for a number of days following irradiation. The mechanism studies are expected to demonstrate UTS-1401 as a new class of agents for mitigating the cytokine storm consequent to the irradiation.", "keywords": [ "Animals", "Biologic Characteristic", "Biological", "Biological Assay", "Biological Availability", "Blood", "Bone Marrow", "Buffers", "Carboxylic Acids", "Cell Death", "Characteristics", "Chemicals", "Complex", "Data", "Development", "Dose", "Drug Delivery Systems", "Drug Kinetics", "Effectiveness", "Electrons", "Exposure to", "FDA approved", "Female", "Femur", "Formulation", "Gender", "Goals", "Hematopoietic", "Hematopoietic System", "Hematopoietic stem cells", "Hour", "Individual", "Inflammatory", "Interleukin-1 beta", "Interleukin-6", "Intestinal Mucosa", "Intestines", "Intravenous", "Ionizing radiation", "Isoxazoles", "Lethal Dose 50", "Measures", "Methods", "Molecular Weight", "Mus", "Nuclear", "Nuclear Accidents", "Nuclear Weapon", "Oral", "Pharmaceutical Preparations", "Plasma", "Property", "Radiation", "Radiation Accidents", "Radiation Dose Unit", "Radiation Injuries", "Radiation Protection", "Radiation Toxicity", "Radiation exposure", "Refrigeration", "Research", "Role", "Route", "Saline", "Sampling", "Series", "Solubility", "Spleen", "Swiss Mice", "Syndrome", "TNF gene", "Tartrates", "Technology", "Terrorism", "Testing", "Time", "Tissues", "Transforming Growth Factor beta", "United States National Institutes of Health", "War", "Weight", "Whole-Body Irradiation", "aqueous", "chemical stability", "cost effective", "cytokine", "cytokine release syndrome", "flexibility", "gastrointestinal", "gender difference", "intravenous administration", "irradiation", "male", "medical countermeasure", "mouse model", "novel", "radiation countermeasure", "radiation mitigation", "radiation mitigator", "radioprotected", "small molecule", "stem cells", "subcutaneous", "success" ], "approved": true } }, { "type": "Grant", "id": "15789", "attributes": { "award_id": "1R56AI191526-01", "title": "Novel Statistical Methods for Confounded and Incomplete Network Data", "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": 32873, "first_name": "MISRAK", "last_name": "GEZMU", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-08-06", "end_date": "2026-07-31", "award_amount": 822015, "principal_investigator": { "id": 9648, "first_name": "Ilya", "last_name": "Shpitser", "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": [ { "id": 32874, "first_name": "Eric Joel", "last_name": "Tchetgen Tchetgen", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2627, "ror": "", "name": "UNIVERSITY OF PENNSYLVANIA", "address": "", "city": "", "state": "PA", "zip": "", "country": "United States", "approved": true }, "abstract": "Studies of public health interventions aimed at controlling the spread of infectious diseases such as HIV/AIDS or COVID19 often face important methodological challenges due to pervasive network dependence, confounding and widespread missing data. Each of these complications has separately received considerable attention, however, methods to tackle them when they coexist are currently lacking. We will develop new statistical methodology, specifically causal identification theory and robust estimation theory which we plan to apply to address pressing scientific questions in infectious disease research using data from two randomized trials and two observational studies with data at hand, where both missing data, and network structure occur including the HAALSA South African Study, the Networks, Norms, and HIV/STI Risk Among Youth (NNAHRAY) study, and the Botswana Combination Prevention Study (BCPP) and the Home-based Interventionto Test and Start (HITS) cluster randomized trial. Success in the proposed research will not only allow for robust conclusions to be drawn from data in the above studies, despite the presence of missing data, the potential for confounding bias, and complex social network structure; it will also provide a methodological template for addressing similar questions beyond these four studies as confounded, missing and dependent data are routinely co-occurring complications in Social and Infectious Disease Epidemiology.", "keywords": [ "Accounting", "Address", "Algorithms", "Area", "Attention", "Botswana", "COVID-19", "Caring", "Cluster randomized trial", "Communicable Diseases", "Communities", "Complex", "Complication", "Data", "Dependence", "Development", "Face", "Family", "Family member", "Formulation", "Goals", "HIV", "HIV/AIDS", "HIV/STD", "Hand", "Health", "Hepatitis C", "Home", "Household", "Human immunodeficiency virus test", "Imprisonment", "Incentives", "Incidence", "Individual", "Infection", "Infectious Disease Epidemiology", "Infectious Diseases Research", "Intervention", "Kinship Networks", "Measures", "Methodology", "Methods", "Modeling", "Observational Study", "Outcome", "Participant", "Policies", "Population", "Prevention", "Prevention program", "Process", "Public Health", "Randomized", "Recording of previous events", "Research", "Risk", "Selection Bias", "Social Interaction", "Social Network", "South African", "Statistical Methods", "Structure", "Techniques", "Testing", "Youth", "behavior test", "community transmission", "financial incentive", "high risk sexual behavior", "interest", "mortality", "novel", "participant enrollment", "prevent", "primary endpoint", "public health intervention", "randomized trial", "semiparametric", "simulation", "social", "success", "theories", "uptake", "user friendly software" ], "approved": true } }, { "type": "Grant", "id": "15787", "attributes": { "award_id": "1R13HD118735-01", "title": "Health, Mortality, & Aging Among People with Criminal Legal System Contact in America", "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": 32868, "first_name": "RANDOLPH CHRISTOPHER", "last_name": "CAPPS", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-08-01", "end_date": "2028-07-31", "award_amount": 10000, "principal_investigator": { "id": 32869, "first_name": "Sade", "last_name": "Lindsay", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 32870, "first_name": "Bryan Lamont", "last_name": "Sykes", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2650, "ror": "", "name": "CORNELL UNIVERSITY", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "PROJECT SUMMARY/ABSTRACT: Criminal justice contact is an important contributor to population variation in health outcomes, including mortality, morbidity, and aging. During and following the COVID-19 pandemic, people in American jails, prisons, and detention centers experienced elevated health risks that exacerbated their already high morality and aging precariousness. This proposal requests support for a three-year conference program on, “Health, Mortality, and Aging Among People with Criminal Legal System Contact in America,” with each year focusing on critical questions about the health of incarcerated people that have emerged since the COVID-19 crisis. These interdisciplinary conferences will harness the research and expertise of established and emerging scholars conducting research at the intersections of health, mortality, and aging in economics, sociology, demography/population science, law, criminology, public health, medicine, and public policy. The proposed conference programs are innovative by including the participation of people affected by legal system involvement, as well as by investigating population heterogeneity to formulate and to advance a bold new research agenda that will benefit affected communities. The program has four specific aims: (1) to advance scientific knowledge and research recommendations to improve health across the life-course for people involved in the criminal legal system; (2) to amplify the voices of affected people, families, and communities; (3) to train the next generation of criminal legal scholars; and (4) to engage multiple audiences. Deliverables will include: (1) three special issues, each devoted to a unique conference theme over the three years (i.e., mortality, health, and aging), allowing for the discrete and unique treatment of each topic; and (2) research briefs that translate findings into potential interventions and recommendations that broadly engage the individuals, families, and communities subject to criminal justice contact, as well as other stakeholders (government officials, prison and court actors, non-profits, and other advocates). By discussing and documenting how life-course transitions that intersect with the criminal legal system matter for socio-economic, health, and well-being, this conference will engage and advance the conceptual and empirical dialogues that began with several National Academies of Sciences, Engineering, and Medicine workshops in 2013 and 2020, and, more recently, a half-day seminar in 2024. As leaders in the criminal legal field, the investigative team and Cornell University are uniquely positioned to host this program.", "keywords": [ "Acute", "Advocate", "Affect", "Aging", "American", "Area", "Attention", "COVID-19 pandemic", "Cessation of life", "Chronic", "Collaborations", "Collection", "Communities", "Community Health", "Consumption", "Correctional Institutions", "Criminal Justice", "Criminology", "Data", "Dedications", "Demography", "Development", "Economics", "Educational workshop", "Engineering", "Epidemiology", "Event", "Exclusion", "Exposure to", "Family", "Government Officials", "Health", "Imprisonment", "Individual", "Intervention", "Jail", "Journals", "Knowledge", "Laws", "Legal", "Legal system", "Life Cycle Stages", "Life Expectancy", "Lived experience", "Measures", "Medicine", "Mentors", "Methodology", "Methods", "Morality", "Morbidity - disease rate", "Outcome", "Participant", "Personal Satisfaction", "Persons", "Population", "Population Heterogeneity", "Population Sciences", "Positioning Attribute", "Prisons", "Public Health", "Public Policy", "Recommendation", "Reporting", "Request for Proposals", "Research", "Research Personnel", "Risk", "Scientific Advances and Accomplishments", "Scientific Inquiry", "Social Sciences", "Sociology", "Training", "Translating", "Translational Research", "United States National Academy of Sciences", "Universities", "Variant", "Voice", "career", "court", "detention center", "experience", "forging", "health difference", "improved", "improved outcome", "individualized medicine", "innovation", "labor market", "life span", "mortality", "next generation", "population health", "prison population", "programs", "public health relevance", "research and development", "socioeconomics", "symposium", "theories" ], "approved": true } }, { "type": "Grant", "id": "15780", "attributes": { "award_id": "1R01CA293884-01A1", "title": "The impact of dyadic processes on smoking and cigarette craving: An experimental investigation of romantic partners and smoking friends", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Cancer Institute (NCI)" ], "program_reference_codes": [], "program_officials": [ { "id": 32857, "first_name": "REBECCA", "last_name": "FERRER", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-08-07", "end_date": "2029-07-31", "award_amount": 2202321, "principal_investigator": { "id": 32858, "first_name": "Amanda", "last_name": "Forest", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 32859, "first_name": "MICHAEL Andrew", "last_name": "SAYETTE", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2644, "ror": "", "name": "UNIVERSITY OF PITTSBURGH AT PITTSBURGH", "address": "", "city": "", "state": "PA", "zip": "", "country": "United States", "approved": true }, "abstract": "Smoking is the leading preventable cause of cancer and mortality in the US, with Covid hitting smokers especially hard. Quitting is difficult (and smoking increased during Covid), yet interventions yield only mixed success. Smokers often smoke and crave cigarettes in social settings. Public health research emphasizes social factors in smoking, and clinical studies point to the need to better understand disrupted relationship dynamics when a romantic partner or friend quits. Thus, it is striking that nearly all lab research (testing causal relations) on smoking and craving tests smokers in isolation. This neglect of social factors extends to quitting practices. Even on the most respected websites, the “social” advice for quitting offers fairly simplistic and incomplete tips that fail to consider subtle yet powerful challenges that quitting may create for smoking friends and romantic partners. Further, there is no evidence regarding how social factors exacerbate the altered smoking-related decision-making that accompanies craving, thus raising the likelihood of smoking. To develop a comprehensive understanding of the factors and processes that maintain smoking and increase relapse risk, basic experimental research that integrates social processes into existing paradigms focusing on pharmacologic and (individual) psychological aspects of addiction is needed. This basic experimental study with humans (BESH) application addresses targeted NCI Behavioral Research Program priorities focused on leveraging research on dyadic processes to examine health-related behaviors such as smoking cessation. Integrating theory and research derived from three disciplines rarely applied to smoking (experimental social psychology with a focus on dyadic processes, affective science, cognition), the project will offer a multimodal analysis of craving and smoking in two social contexts relevant to smoking (friendships, romantic couples). This project will use innovative measures of affect (e.g., an urge pressure dynamometer, speech volume, Facial Action Coding System) and decision-making to test theoretically-derived processes (e.g., shared reality, motivated reasoning, emotional contagion) that may help explain the challenges linked to quitting when rewarding social aspects of smoking are lost. The project will elucidate why some smokers may struggle managing relationships when quitting, and why social interventions may be most useful for a subset of smokers. In both a friends study and a couples study, abstinent daily and nondaily smokers will be recruited. The friends study will test the impact of a friend’s presence on cue-elicited craving, with a focus on shared craving states, and the couples study will target effects of mutual smoking versus unilateral smoking on critical social interactions and relationship perceptions thought to raise obstacles to quitting. This project will test important social-cognitive and socio- emotional mechanisms underlying craving and smoking that may identify hidden social motives for smoking that must be integrated into biopsychosocial smoking treatment. Regardless of outcome, this work will provide valuable data on emotional and cognitive processes experienced in social settings during craving and smoking.", "keywords": [ "Acoustics", "Address", "Affect", "Affective", "American", "Behavioral Research", "Cancer Etiology", "Cessation of life", "Cigarette", "Clinical", "Clinical Research", "Code", "Cognition", "Cognitive", "Couples", "Cues", "Data", "Decision Making", "Discipline", "Disclosure", "Electronic cigarette", "Emotional", "Emotions", "Event", "Face", "Friends", "Friendships", "Future", "Goals", "Health", "Health behavior", "Human", "Individual", "Intervention", "Investigation", "Language", "Link", "Malignant Neoplasms", "Measures", "Methodology", "Methods", "Modeling", "Monitor", "Nicotine", "Nicotine Dependence", "Outcome", "Patient Self-Report", "Perception", "Persons", "Pharmaceutical Preparations", "Play", "Preventable cancer cause", "Process", "Public Health", "Reporting", "Research", "Rewards", "Role", "Science", "Smiling", "Smoke", "Smoker", "Smoking", "Smoking treatment", "Social Environment", "Social Interaction", "Social Processes", "Social Psychology", "Speech", "Subgroup", "Testing", "Tobacco", "Treatment Efficacy", "Work", "addiction", "biopsychosocial", "cigarette craving", "cigarette smoking", "cognitive process", "contagion", "craving", "experience", "experimental study", "heuristics", "innovation", "insight", "member", "mortality", "multimodality", "neglect", "novel", "pharmacologic", "premature", "pressure", "prevent", "programs", "psychologic", "public health research", "recruit", "relapse risk", "smoking cessation", "smoking cue", "social", "social factors", "social interventions", "social relationships", "success", "theories", "web site" ], "approved": true } }, { "type": "Grant", "id": "15779", "attributes": { "award_id": "1R01AI197146-01", "title": "SCH: A structural causal framework for adaptive experiments", "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": 32567, "first_name": "MEGHAN ANN", "last_name": "HARTWICK", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-08-06", "end_date": "2029-07-31", "award_amount": 299422, "principal_investigator": { "id": 32855, "first_name": "Ivan", "last_name": "Diaz", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 32856, "first_name": "Michele", "last_name": "Santacatterina", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2643, "ror": "", "name": "NEW YORK UNIVERSITY SCHOOL OF MEDICINE", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "Adaptive randomized clinical trials are critical in infectious disease research, offering flexibility to adjust sample sizes, introduce new interventions, discontinue ineffective treatments, and target specific subgroups to enhance treatment efficacy. This adaptability is particularly valuable in rapidly evolving public health crises, such as the development of treatments for emerging infectious diseases like COVID-19. However, adaptive trials present significant challenges, including unclear inferential targets, statistical biases from temporal and spatial variability, complexities in handling dynamic data structures, and an increased risk of false-positive findings. These concerns are reflected in recent FDA guidance on estimands, which emphasizes the need for clearly defined inferential targets, and on adaptive designs, which acknowledges that statistical bias in adaptive trials remains an understudied issue. Despite these recognized challenges, current research lacks a principled framework for structurally representing and unbiasedly estimating causal effects in adaptive trials. This project will develop a structural causal framework for adaptive trials, leveraging modern causal inference and statistical techniques alongside secondary data from the Adaptive COVID-19 Treatment Trial (ACTT)—an adaptive trial evaluating novel therapeutics in hospitalized COVID-19 patients—to enable transparent, efficient, and statistically unbiased estimation of causal effects. To achieve this, we propose the following specific aims: Aim 1: Develop a structural causal approach that deals with temporal variability. Aim 2: Extend our framework to handle spatial variability. Aim 3: Expand our framework to handle complex data structures, including failure-time and missing data, while dealing with false-positive results. Our project aligns with NIAID’s mission by advancing key methodologies for infectious disease clinical trials, particularly in adaptive designs for pandemic response, emerging pathogens, and the development of antiviral treatments. While our primary focus is on infectious disease trials, our methods have broader applicability to other disease areas, such as schizophrenia. We show this by also leveraging secondary data from schizophrenia studies, including the DECIFER trial, the RAISE study, and the EPINET study. RELEVANCE (See instructions): This research aims to improve how adaptive clinical trials are designed and analyzed. By developing methods that address key challenges in adaptive trials, our work will help ensure more accurate and reliable results, ultimately leading to better treatments and public health responses to emerging infectious diseases.", "keywords": [ "Address", "Area", "COVID-19", "COVID-19 patient", "COVID-19 treatment", "Clinical Trials", "Clinical Trials Design", "Communicable Diseases", "Data", "Disease", "Emerging Communicable Diseases", "Ensure", "Failure", "Hospitalization", "Infectious Diseases Research", "Instruction", "Intervention", "Methodology", "Methods", "Mission", "Modernization", "National Institute of Allergy and Infectious Disease", "Public Health", "Reliability of Results", "Research", "Risk", "Sample Size", "Schizophrenia", "Statistical Bias", "Structure", "Subgroup", "Techniques", "Time", "Treatment Efficacy", "Work", "antiviral drug development", "complex data", "design", "emerging pathogen", "experimental study", "flexibility", "improved", "ineffective therapies", "novel therapeutics", "pandemic response", "randomized clinical trials", "response", "spatiotemporal", "therapy development", "treatment trial" ], "approved": true } }, { "type": "Grant", "id": "15777", "attributes": { "award_id": "1R01AR085033-01", "title": "Improving the diagnosis and outcome of diffuse alveolar hemorrhage in systemic lupus erythematosus", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)" ], "program_reference_codes": [], "program_officials": [ { "id": 32850, "first_name": "MARIE", "last_name": "MANCINI", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-08-06", "end_date": "2030-06-30", "award_amount": 538755, "principal_investigator": { "id": 32851, "first_name": "WESTLEY H", "last_name": "REEVES", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 32852, "first_name": "Haoyang", "last_name": "Zhuang", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2642, "ror": "", "name": "UNIVERSITY OF FLORIDA", "address": "", "city": "", "state": "FL", "zip": "", "country": "United States", "approved": true }, "abstract": "The variable clinical manifestations of SLE patients are largely unexplained. Although severe diffuse alveolar hemorrhage (DAH) with pulmonary capillaritis is unusual in lupus, more than half of patients with this complication die and focal lung hemorrhage occurs in 30-66% of patients. Using a mouse model (pristane-induced lupus) developed in our laboratory, we will ask why C57BL/6 (B6) mice are susceptible to pristane-induced DAH/vasculitis whereas BALB/c and DBA/2 mice are resistant. DAH is initiated by lung endothelial cell (EC) injury followed by recruitment of bone marrow-derived monocytes to the lung. We found that dysregulation of the extrinsic coagulation pathway also is involved and that lung disease is abolished by early treatment with MEK1/2 or ERK1/2 inhibitors. The overall hypothesis is that genetically- determined lung microvascular EC injury evolves into DAH because of monocyte infiltration into the lung and abnormal regulation of the extrinsic coagulation pathway. Aim 1 addresses susceptibility to DAH. We will ask whether EC injury and bleeding are lung-specific and investigate gene expression patterns associated with DAH by single-cell RNA-sequencing. Genes conferring susceptibility/resistance to EC injury and bleeding be mapped in recombinant inbred BXD (B6 X D2) mice. Aim 2 examines the MEK1/2-ERK1/2 pathway in pristane-induced DAH. We will define the sequence of events leading to DAH and develop blood-based diagnostic tests for the diagnosis of incipient DAH prior to the onset of bleeding. This is important, because the disease process is irreversible once hemorrhage begins. We will look for tests that distinguish early DAH (pre-bleeding) from other forms of lung injury, such as sepsis with acute respiratory distress syndrome. Aim 3 translates what is learned in mice to human DAH. We hypothesize that the disease process is similar except that the initial EC injury is caused by respiratory viral infections rather than pristane. We will ask if a predisposition to lung EC injury determines susceptibility, as in mice, and whether diagnostic approaches developed in the mouse model are relevant to human DAH. Lung EC injury will be examined in SLE patients with influenza or COVID infection and the role of mild bleeding disorders will be explored. The ability to diagnose incipient DAH (pre- bleeding) may permit future therapeutic trials using FDA-approved MEK1/2 inhibitors, such as trametinib, which are highly effective in pristane-induced DAH.", "keywords": [ "ANCA vasculitis", "Acute Respiratory Distress Syndrome", "Address", "Adopted", "Alveolar", "Antineutrophil Cytoplasmic Antibodies", "Autoantibodies", "Autoimmune", "Autoimmune Diseases", "BALB/cJ Mouse", "Biological Assay", "Blood", "Blood Coagulation Disorders", "Blood Vessels", "Bone Marrow", "C57BL/6 Mouse", "COPA syndrome", "Cell Line", "Clinical", "Coagulation Process", "Complex", "Complication", "DBA/2 Mouse", "Data", "Defect", "Dependence", "Development", "Diagnosis", "Diagnostic tests", "Diffuse", "Disease", "Disease susceptibility", "Early Diagnosis", "Early treatment", "Endothelial Cells", "Environmental Risk Factor", "Enzyme-Linked Immunosorbent Assay", "Event", "Exanthema", "Exhibits", "FDA approved", "Future", "Gene Expression", "Gene Expression Profile", "Genes", "Genetic", "Genetic Predisposition to Disease", "Hemorrhage", "Hemostatic function", "Human", "Immune", "Immunologics", "Inbred BALB C Mice", "Inbreeding", "Infiltration", "Inflammation", "Inherited", "Injury", "Intervention", "Kidney", "Laboratories", "Learning", "Life", "Link", "Lung", "Lung Diseases", "Lupus", "Lupus Nephritis", "MAP2K1 gene", "MAPK3 gene", "Malignant Neoplasms", "Maps", "Mediating", "Mitogen-Activated Protein Kinases", "Modeling", "Monitor", "Mouse Strains", "Mus", "NUP214 gene", "Outcome", "Pathogenesis", "Pathway interactions", "Patients", "Plasma", "Predisposition", "Pristane", "Process", "Prognosis", "Public Health", "Qualifying", "Recombinants", "Regulation", "Resistance", "Respiratory Tract Infections", "Retinal blind spot", "Role", "SARS-CoV-2 infection", "Sepsis", "Serum", "Severity of illness", "Systemic Lupus Erythematosus", "Testing", "Therapeutic Trials", "Tissues", "Translating", "Vascular Diseases", "Vasculitis", "Viral Respiratory Tract Infection", "cell injury", "diagnostic strategy", "ds-DNA", "experience", "genome wide association study", "immune function", "improved", "influenza infection", "inhibitor", "injured", "lung injury", "lung microvascular endothelial cells", "monocyte", "mouse model", "novel therapeutics", "prevent", "protein expression", "pulmonary", "recruit", "sepsis induced ARDS", "single-cell RNA sequencing", "treatment response" ], "approved": true } }, { "type": "Grant", "id": "15775", "attributes": { "award_id": "1R01AI193318-01", "title": "Assessing the mechanisms underlying female sex-predominance in Long COVID", "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": 32597, "first_name": "BROOKE ALLISON", "last_name": "BOZICK", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-08-22", "end_date": "2030-07-31", "award_amount": 913012, "principal_investigator": { "id": 31372, "first_name": "Michael Joseph", "last_name": "Peluso", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 32848, "first_name": "Nadia R", "last_name": "Roan", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2635, "ror": "", "name": "UNIVERSITY OF CALIFORNIA, SAN FRANCISCO", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "Long COVID, or post-acute sequelae of COVID-19 (PASC), is estimated to occur after ~10% of COVID-19 cases and affects tens of millions of people worldwide. The mechanisms underlying Long COVID remain poorly understood, which hinders the ability to establish effective evidence-based treatments for the condition. One of the most striking observations in the epidemiology of Long COVID is its female sex predominance: women, particularly pre-menopausal women, are much more likely than men to have the condition. In this proposal, we leverage the Long-term Impact of Infection with Novel Coronavirus (LIINC) cohort (NCT04362150) – which since April 2020 has recruited >1,000 participants with and without Long COVID – to interrogate the mechanistic basis underlying the increased prevalence of Long COVID in women. Our central hypothesis is that in women with Long COVID, there is an elevated and sustained immune type I IFN (T1IFN) response to SARS-CoV-2 (SCV2) gene products, which in turn diminishes the quality of adaptive immune responses against chronic herpesviruses (EBV, CMV) and SCV2 itself, increases the risk of pathogenic autoantibody responses, and results in overall systemic inflammation and immune dysregulation that is characteristic of Long COVID. We further postulate that both incomplete X chromosome inactivation and sex hormones drive the elevated T1IFN responses in women with Long COVID. In Aim 1, we will subject banked longitudinal blood specimens from women and men from LIINC (including both those with and without Long COVID) to assays that will measure the extent of persistent SCV2, T1IFN responses, the features of adaptive immune responses to persistent viruses associated with Long COVID (SCV2, EBV, CMV), autoantibody responses, and the overall state of inflammation. In Aim 2, we will leverage the LIINC Tissue Biopsy program to obtain paired endometrial and gut biopsies from women with Long COVID, to test the hypothesis that the endometrium is a key site of SCV2 persistence and immune dysregulation during Long COVID. This analysis will be compared to a parallel set of studies using gut specimens from matched men with Long COVID. Finally, Aim 3 will analyze specimens from two clinical trials designed to eliminate SCV2 gene products as treatment for Long COVID. The first of these, performed by Resolve Therapeutics, found that administration of RSLV-132, a catalytically active RNase1 intended to degrade SCV2 RNA, improved Long COVID symptoms in women but not men (NCT04944121). The second, occurring within LIINC, is ongoing (enrollment is complete) and testing the effects of AER002, a monoclonal antibody that directly targets and clears SCV2 protein (NCT05877508). Using specimens from both trials, we will test the notion that SCV2 gene products drive sustained T1IFN responses in women that contribute to Long COVID symptoms. Collectively, our aims will improve our understanding of the mechanisms underlying the female-predominance of Long COVID and improve our overall understanding of the disease. This will be a key step in the identification of evidence-based treatments for both women and men who continue to develop and live with this disabling condition.", "keywords": [ "2019-nCoV", "Acute", "Affect", "Age", "Antibodies", "Antibody Response", "Antigens", "Autoantibodies", "Autoimmunity", "Biological", "Biological Assay", "Biology", "Biopsy", "Biopsy Specimen", "Blood", "Blood specimen", "Body System", "COVID-19", "COVID-19 impact", "COVID-19 prevalence", "Characteristics", "Chronic", "Clinical Trials", "Clinical Trials Design", "Cytomegalovirus", "Data", "Disabling condition", "Disease", "Disproportionately impacts women", "Endometrial", "Endometrium", "Enrollment", "Epidemiology", "Estradiol", "Evidence based treatment", "Exhibits", "Fatigue", "Female", "Functional impairment", "Genes", "Genitourinary system", "Gonadal Steroid Hormones", "Health", "Herpesviridae", "High Prevalence", "Human Herpesvirus 4", "Immune", "Immune System Diseases", "Immune response", "Immunity", "Individual", "Infection", "Inflammation", "Inflammatory", "Inflammatory Response", "Interferons", "Intervention", "Intervention Trial", "Link", "Long COVID", "Longitudinal Studies", "Measurement", "Measures", "Monoclonal Antibodies", "Nature", "Observational epidemiology", "Organ", "Outpatients", "Paper", "Participant", "Pathway interactions", "Persons", "Phenotype", "Post-Acute Sequelae of SARS-CoV-2 Infection", "Premenopause", "Prevalence", "Progesterone", "Proteins", "Publishing", "RNA", "Research Infrastructure", "Risk", "SARS-CoV-2 infection", "SARS-CoV-2 inhibitor", "Sex Differences", "Signal Transduction", "Site", "Specimen", "Symptoms", "T cell response", "TLR7 gene", "Testing", "Testosterone", "Therapeutic", "Tissues", "Vaccination", "Viral", "Virus", "Virus Diseases", "Woman", "Women's prevalence", "X Inactivation", "acute COVID-19", "adaptive immune response", "brain fog", "cohort", "common symptom", "design", "experience", "female reproductive tract", "gene product", "improved", "interest", "longitudinal analysis", "men", "mucosal site", "novel coronavirus", "pathogenic autoantibodies", "programs", "prospective", "randomized trial", "recruit", "repository", "response", "sex", "single-cell RNA sequencing", "systemic inflammatory response", "therapy design", "transcriptome", "women's outcomes" ], "approved": true } } ], "meta": { "pagination": { "page": 1, "pages": 1405, "count": 14046 } } }