NIH_SPENDING_CATS: Aging;Basic Behavioral and Social Science;Behavioral and Social Science;Clinical Research;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Mental Health;Prevention;Racial and Ethnic Minority Health Research;Social Determinants of Health

ORG_CITY: SAN FRANCISCO

ORG_NAME: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

PHR: Public Health Relevance Statement Structural racism and discrimination negatively shape the health of older, racialized, and sexual and gender minorities (SGM), including those living with HIV. The manner in which structural racism and discrimination affect the various subgroups within this population (along race, ethnicity and HIV status), is expected to vary, yet it is poorly understood. The purpose of this study is to assess the relationships among health, structural racism and discrimination, stigma, resources, and biomarkers of health and aging in older SGM of four ethno/racial groups: African American, Latinx, Asian American, and white— and across HIV status. The findings of this study may help understand how structural, individual, and biological factors differently affect the health of older SGM and the ways in which prevention efforts may be improved.

PI_NAMEs: RAMIREZ-VALLES, JESUS  (contact)

PROGRAM_OFFICER_NAME: GERALD, MELISSA S

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Address;Adherence;Administrative Supplement;Affect;African American;African American population;Ageism;Aging;Anti-Retroviral Agents;Area;Asian Americans;Biological;Biological Factors;Biological Markers;C-reactive protein;Cell Aging;cognitive function;Color;Communities;community involvement;community partners;comorbidity;Complex;Consequences of HIV;Cross-Sectional Studies;Data;Discrimination;diverse data;Environment;Ethnic Origin;Ethnic Population;experience;Exposure to;Face;Foundations;Gays;Gender Identity;gender minority group;gender minority health;gender minority health research;Goals;Health;health assessment;health disparity;health inequalities;Heterosexuals;HIV;HIV risk;HIV Seronegativity;HIV/AIDS;human old age (65+);improved;Individual;Inflammation;Interleukin-10;Interleukin-6;internalized stigma;Intervention;Interview;Latinx;Learning;Length;Leukocytes;Life Cycle Stages;Longitudinal Studies;man;Mediating;men;Mental Depression;Mental Health;Methods;minority health;minority health disparity;multidisciplinary;Older Population;Outcome;parent grant;Personal Satisfaction;Persons;Pharmaceutical Preparations;Play;Population;Prevention;Process;protective factors;public health relevance;Race;racial population;racism;Recording of previous events;Research;residential segregation;Resources;Respondent;response;Risk;Risk Factors;Role;Sampling;Sampling Biases;San Francisco;Sexual and Gender Minorities;sexual minority group;Shapes;social integration;social stigma;Social support;Stigmatization;Strategic Planning;Stress;Structural Racism;Subgroup;substance use;synergism;telomere;Testing;theories;TNF gene;transgender;transgender women;United States National Institutes of Health

PROJECT_TITLE: Structural Racism and Discrimination in Sexual and Gender Minority Health Inequities - Supplement


ADMINISTERING_IC: DC

ARRA_FUNDED: N

ED_INST_TYPE: SCH ALLIED HEALTH PROFESSIONS

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

NIH_SPENDING_CATS: Aging;Basic Behavioral and Social Science;Behavioral and Social Science;Hearing Loss;Neurosciences

ORG_CITY: PITTSBURGH

ORG_COUNTRY: UNITED STATES

ORG_DEPT: OTHER HEALTH PROFESSIONS

ORG_FIPS: US

ORG_NAME: UNIVERSITY OF PITTSBURGH AT PITTSBURGH

ORG_STATE: PA

PHR: Project Narrative Hearing difficulties with age may be due to the progressive loss of nerve connections in the inner ear, but this loss does not show up in current clinical tests. The proposed study will integrate research in humans and an animal model with human-like hearing, to develop new diagnostic tests for this ‘hidden’ hearing loss. The completion of this study could lead to novel diagnostic tests that can be used to detect this loss of inner ear nerve connections in the clinic, all while setting up a translational research pipeline to develop future diagnostics and test therapies for various forms of hearing loss.

PI_NAMEs: PARTHASARATHY, ARAVINDAKSHAN  (contact)

PROGRAM_OFFICER_NAME: CYR, JANET

PROJECT_TERMS: Acceleration;Acoustic Nerve;Address;Affect;Age;age effect;age related;Age Years;Anatomy;Animal Model;Auditory;auditory pathway;Auditory Threshold;Autopsy;Behavioral;Biological Markers;Clinic;Clinical;Cochlea;cochlear synaptopathy;Code;Communication;Complex;Cues;Data;Diagnostic;Diagnostic tests;Electrophysiology (science);experience;experimental study;Frequencies;Future;Hearing;hearing impairment;hearing range;Hearing Tests;hidden hearing loss;Human;human model;Individual;Inner Hair Cells;juvenile animal;Labyrinth;Link;Measures;Methods;Nerve;neural;novel diagnostics;older adult;Peripheral;preclinical study;Presbycusis;Quality of life;Research;response;Rodent Model;Role;Specimen;Speech;speech in noise;Speech Intelligibility;Speech Perception;Stimulus;Structure;Synapses;Testing;Therapeutic Intervention;translational approach;Translational Research;Translations

PROJECT_TITLE: Research Supplement - Luz Andrino

STUDY_SECTION: CDRC

STUDY_SECTION_NAME: Communication Disorders Review Committee[CDRC]


ADMINISTERING_IC: GM

ED_INST_TYPE: SCHOOLS OF MEDICINE

FUNDING_MECHANISM: RESEARCH CENTERS

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Autism;Basic Behavioral and Social Science;Behavioral and Social Science;Brain Disorders;Building Research Capacity at Institutions with Limited NIH Funding;Clinical Research;Fragile X Syndrome;Hearing Loss;Intellectual and Developmental Disabilities (IDD);Mental Health;Microbiome;Neurosciences;Pediatric;Rare Diseases

ORG_CITY: COLUMBIA

ORG_DEPT: PATHOLOGY

ORG_NAME: UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA

ORG_STATE: SC

PHR: PROJECT NARRATIVE Autism spectrum disorder is a common neurodevelopmental disorder affecting 1 in 36 children. Many with autism spectrum disorder suffer from gastrointestinal problems, and experimental studies have shown that treatments targeting the gut microbiome may lessen autism-associated behavioral differences. The goal of this proposal is to evaluate the role of the gut microbiome in hearing and behavioral differences found in an animal model of ASD.

PI_NAMEs: GOLDSMITH, EDIE C (contact)

PROGRAM_OFFICER_NAME: MATUKUMALLI, LAKSHMI KUMAR

PROJECT_TERMS: Adult;Adult women;Affect;Animal Model;ARHGEF5 gene;ASD patient;Auditory;Auditory Brainstem Responses;Auditory Perceptual Disorders;auditory processing;Auditory system;autism spectrum disorder;Behavior;behavior measurement;Behavioral;beta diversity;Biological Assay;Biomedical Research;Birth;Centers of Research Excellence;Characteristics;Child;Chronic;Cochlea;Collaborations;Communication;communication behavior;Courtship;Development;Diagnosis;dysbiosis;Exhibits;Exons;experience;experimental study;Female;FMR1 gene;Fostering;Fragile X Syndrome;Funding;gastrointestinal;Goals;graduate school;gut dysbiosis;gut microbiome;gut microbiota;gut-brain axis;Health;Hearing;hearing impairment;Hyperacusis;Hypersensitivity;Immunofluorescence Immunologic;Inflammation;inner ear development;innovation;interest;Intestinal permeability;Knockout Mice;Laboratories;Laboratory Research;Life;Loudness;male;Medical;microbial;microbiome;microbiota;microbiota transplantation;model of autism spectrum disorder;mouse model;Mus;myelination;Neurodevelopmental Disorder;neuroinflammation;Neurosciences;Nutritional;Pathologic;Peripheral;Persons;preference;promoter;pup;Research Personnel;response;Retrieval;Ribosomal RNA;Rodent Model;Role;Sensory;Sex Differences;social;Social Behavior;social communication;Social Interaction;sound;South Carolina;spiral ganglion;statistics;Stereotyped Behavior;Synapses;Testing;Therapeutic;tool;Training;translational therapeutics;Transplantation;Ultrasonics;undergraduate student;Universities;Visit;vocalization;Work

PROJECT_TITLE: South Carolina IDeA Networks of Biomedical Research Excellence (SC INBRE) - Collaborative Supplement on The Role of Gut Microbiome in Hearing Impairment in a Mouse Model of Autism Spectrum Disorder


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Estrogen;Genetics;HIV/AIDS;Human Genome;Infectious Diseases;Nutrition;Obesity;Prevention;Women's Health Research

ORG_CITY: BALTIMORE

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: JOHNS HOPKINS UNIVERSITY

ORG_STATE: MD

PHR: NARRATIVE The introduction of the integrase strand transfer inhibitor (INSTI) class revolutionized the treatment of people with HIV infection due to their high efficacy, greater tolerability, and fewer drug-drug interactions. However, recent studies have raised potential concerns for weight gain in patients receiving INSTIs, especially in women. This proposal will elucidate a potential sex-dependent mechanism by which INSTIs disrupt metabolic balance, leading to weight gain.

PI_NAMEs: BROWN, TODD T;KIM, SANGWON F (contact);KOETHE, JOHN

PROGRAM_OFFICER_NAME: GUPTA, DHANANJAY

PROJECT_TERMS: Address;Adipocytes;Adipose tissue;Affect;antiretroviral therapy;ATAC-seq;Attenuated;Biochemical;Biological Assay;Biology;Body fat;Body Weight;Cardiovascular Diseases;Central Nervous System;Chronic;comorbidity;Complement;Data;design;Development;diabetes risk;Drug Design;Drug Interactions;emtricitabine;Energy Metabolism;Equilibrium;estrogen disruption;Estrogen Receptors;Estrogen Replacements;Estrogens;Fatty acid glycerol esters;Female;Functional disorder;Gene Expression;Genetic;High Fat Diet;HIV;HIV Infections;Homeostasis;Human;in vivo;Individual;Infection;inhibitor;insight;Integrase;Intervention;Investigation;Laboratories;male;Mediating;men;Metabolic;Metabolic dysfunction;Metabolism;Mitochondria;Molecular;Molecular Analysis;mouse model;multidisciplinary;Multiomic Data;multiple omics;Mus;nonhuman primate;Obesity;Ovariectomy;Pathway interactions;Patients;Peripheral Nervous System;Personal Satisfaction;Persons;Pharmaceutical Preparations;Phenotype;Play;Pre-Clinical Model;Prevention;Process;Proteins;Randomized;Regimen;Regulatory Pathway;Reporting;Research;Respiration;Rodent;Rodent Model;Role;sex;Sex Differences;sexual dimorphism;Shapes;Signal Pathway;Signal Transduction;single nucleus RNA-sequencing;single-cell RNA sequencing;SIV;Tenofovir;Testing;Thermogenesis;Time;Tissue Sample;Tissues;transcriptomics;Transgenic Mice;Transgenic Organisms;translational study;Transposase;uncoupling protein 1;Universities;Viremia;Virus Diseases;Weight Gain;Weight maintenance regimen;Woman;Work

PROJECT_TITLE: Defining cellular and molecular processes underlying adipose tissue dysfunction onINSTI-based antiretroviral therapy

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 IIDB-R (02)]


ORG_CITY: STONY BROOK

ORG_DEPT: BIOCHEMISTRY

ORG_NAME: STATE UNIVERSITY NEW YORK STONY BROOK

ORG_STATE: NY

PHR: Project Narrative Understanding how cells move lies at the heart of combating debilitating diseases like cancer. While cells typically extend actin-rich protrusions to move in culture, cells in developing organisms and tumors can move without them. The research proposed here uses a developmental model to understand how alternative forms of cell movement function and will improve human health by identifying new therapeutic targets to stop malignant cell migration.

PI_NAMEs: LIN, BENJAMIN C (contact)

PROGRAM_OFFICER_NAME: AINSZTEIN, ALEXANDRA M

PROJECT_TERMS: 3-Dimensional;Actins;Actomyosin;Address;Architecture;Bulla;cancer cell;cancer invasiveness;cell behavior;cell motility;Cell Therapy;Cells;Characteristics;Coupled;Cues;Development;Disease;Drosophila genus;Embryo;Endowment;Environment;Health;Heart;Human;human disease;improved;in vivo;Malignant Neoplasms;Mechanics;migration;Modeling;Molecular;Motility;Movement;Nature;new therapeutic target;non-genetic;Organ;Organism;pathogen;permissiveness;pressure;Productivity;Reproducibility;Research;seal;Shapes;Structure of primordial sex cell;Surface;System;Therapeutic Intervention;Traction;transmission process;Travel;tumor;two-dimensional;wound

PROJECT_TITLE: Deconstructing fast amoeboid cell migration

STUDY_SECTION: MRAC

STUDY_SECTION_NAME: Maximizing Investigators' Research Award C Study Section[MRAC]


ADMINISTERING_IC: DA

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Clinical Research;Drug Abuse (NIDA only);Lung;Opioid Misuse and Addiction;Opioids;Patient Safety;Substance Misuse;Telehealth

ORG_CITY: SANTA CLARA

ORG_NAME: AUTONOMOUS HEALTHCARE, INC.

ORG_STATE: CA

PHR: The US opioid crisis continues to have a catastrophic impact on human lives and the ongoing COVID-19 pandemic is compounding its effects. We propose to build on our work in non-invasive monitoring of vital signs to develop an FDA-regulated medical device with a primary application in monitoring patients for opioid- induced respiratory depression. This includes at-home monitoring of patients with chronic pain being treated with high-dose opioid prescription medications or patients suffering from opioid use disorder (OUD) as well as monitoring subjects with OUD at supervised injection sites (also known as supervised consumption spaces).

PI_NAMEs: GHOLAMI, BEHNOOD  (contact)

PROGRAM_OFFICER_NAME: ANGELONE, LEONARDO MARIA

PROJECT_TERMS: Age;Anesthesia procedures;Area;Chest;Chest wall structure;chronic pain patient;Clothing;Complement;Consumption;COVID-19 pandemic;Data;data integration;design;Detection;detection platform;Dose;Drug Prescriptions;Family suidae;Goals;healthy volunteer;Home;Human;Image;imaging system;Injections;machine learning model;Measures;Medical Device;Modeling;Monitor;Movement;multimodality;non-invasive monitor;Opioid;opioid epidemic;opioid use disorder;Outcome;overdose death;Patient Monitoring;Patients;Pattern;Penetration;Persons;Pharmaceutical Preparations;prescription opioid;Publishing;Radar;remote monitoring;Respiration;respiratory;sensor;Signal Transduction;Site;statistics;System;Technology;Testing;Tidal Volume;Validation;Ventilatory Depression;Work

PROJECT_TITLE: Noncontact Remote Monitoring for the Detection of Opioid-Induced Respiratory Depression


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Drug Abuse (NIDA only);Fentanyl Misuse and Addiction;Harm Reduction for Substance Misuse;Nanotechnology;Opioid Misuse and Addiction;Opioids;Substance Misuse

ORG_CITY: LANCASTER

ORG_NAME: LYNTHERA CORPORATION

PHR: PROJECT NARRATIVE Background – The proposed I-Corps project is based on a predicate SBIR Phase I award for the development of a long-lasting, sustained release of NLX product using a novel system of a pH/temperature-sensitive hydrogel embedded with NLX-encapsulated solid lipid nanoparticles (SLNs), employed in an in-situ gelling, subcutaneous injectable formulation. The goal of the I-Corps project is to develop market expertise and intelligence to improve the chances of success for commercialization through a future Phase II project, while also undergoing valuable training for this effort. A successful project will help contribute to an important solution for the American opioid epidemic, which is a national health emergency marked by over 80,000 overdose deaths per year and an annual cost exceeding $1.02 trillion.

PI_NAMEs: TORRES LUNA, CESAR  (contact)

PROGRAM_OFFICER_NAME: NGUYEN, TAM L

PROJECT_TERMS: American;antinociception;Award;career;commercialization;copolymer;cost;Development;Drug Delivery Systems;Emergency Situation;Encapsulated;Equity;experience;Family;Fentanyl;Formulation;Funding;Future;Goals;Grant;Health;Healthcare;Human Resources;Hydrogels;improved;In Situ;in vivo;Industrialization;Industry;Injectable;Innovation Corps;Intelligence;Investments;Lead;lipid nanoparticle;manufacture;Marketing;Modeling;Naloxone;nanocomposite;nanomedicine;Nanotechnology;novel;opioid epidemic;opioid overdose;overdose death;Pharmacologic Substance;Phase;Polymers;prevent;Principal Investigator;Privatization;Rattus;Research;research and development;rhein;Role;Science;Scientist;Small Business Innovation Research Grant;Solid;subcutaneous;Subcutaneous Injections;success;System;Technology;Temperature;Time;Training;United States National Institutes of Health;Ventilatory Depression

PROJECT_TITLE: I-Corps for Novel Formulation Technology for Sustained Release Naloxone


ADMINISTERING_IC: MD

IC_NAME: NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES

NIH_SPENDING_CATS: Autoimmune Disease;Behavioral and Social Science;Biodefense and Related Countermeasures;Clinical Research;Coronaviruses;Coronaviruses Disparities and At-Risk Populations;Emerging Infectious Diseases;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Lupus;Post-Acute Sequelae of SARS-CoV-2 infection (PASC) including Long COVID;Prevention;Racial and Ethnic Minority Health Research;Social Determinants of Health;Women's Health Research

ORG_CITY: CHARLESTON

ORG_NAME: MEDICAL UNIVERSITY OF SOUTH CAROLINA

PHR: PROJECT NARRATIVE Systemic lupus erythematosus (SLE, or lupus) is a chronic multisystem autoimmune disease characterized by the production of autoantibodies, disproportionately affecting African American women, with whom it is associated with significant mortality and morbidity, and without safe and effective treatments. Since the relationships between lupus and COVID-19 in the context of social determinants of health (SDOH) remain largely unknown, this study will investigate the relationships between lupus and COVID-19 in African American women. The proposed research is relevant to public health because it could lead to improvements in our understanding of the impact of COVID-19 in lupus and its disparities, informing the development of interventions to support patients with long COVID, which will be essential for the maintenance of high-quality, patient-centered, efficient clinical care of this health disparity population.

PI_NAMEs: RAMOS, PAULA SOFIA (contact)

PROGRAM_OFFICER_NAME: BICKHAM-WRIGHT, UTIBE RONALD

PROJECT_TERMS: Accounting;Acute Disease;Administrative Supplement;Adrenal Cortex Hormones;adverse outcome;Affect;African American;African American population;African American Women;aged;Antibodies;Antigens;Anxiety;Autoantibodies;Autoimmune Diseases;Award;Behavior;Behavioral;Biological;Biological Assay;biopsychosocial;Caring;Censuses;Cessation of life;Chronic;Clinical;clinical care;Communities;comorbidity;Complement;Computerized Medical Record;COVID-19;COVID-19 burden;COVID-19 impact;COVID-19 morbidity;COVID-19 pandemic;COVID-19 risk;COVID-19 test;COVID-19 vaccination;Data;Death Rate;Development;Dimensions;Disease;Disease Management;Disparity;Disproportionately impacts women;effective therapy;Enrollment;Environmental Exposure;Epigenetic Process;epigenomics;experience;Funding;Future;gene function;Genetic;Goals;Health;health data;health determinants;health disparity populations;High Prevalence;high risk population;Hospitalization;Household;Hydrocortisone;improved;Income;Individual;Infection;Infrastructure;Knowledge;Life Cycle Stages;Long COVID;Lupus;Maintenance;marginalized population;Measures;Medical Records;Mental Depression;Modeling;Morbidity - disease rate;mortality;multidisciplinary;National Institute on Minority Health and Health Disparities;novel;Outcome;parent grant;parent project;Parents;Participant;patient oriented;Patient Self-Report;Patients;personalized risk prediction;Persons;physical symptom;post-COVID-19;post-pandemic;pre-pandemic;Prevalence;Prevention;Prevention strategy;Production;prototype;Public Health;racial discrimination;Recording of previous events;Records;recruit;Research;Research Infrastructure;response;Risk;Risk Factors;Risk Marker;Sampling;SARS-CoV-2 antibody;SARS-CoV-2 antigen;SARS-CoV-2 exposure;SARS-CoV-2 infection;SARS-CoV-2 infection history;SARS-CoV-2 variant;severe COVID-19;Severities;Severity of illness;social;social culture;social factors;social health determinants;social stressor;Social support;social vulnerability;sociodemographics;stressor;Symptoms;System;Systemic Lupus Erythematosus;Test Result;Testing;Therapeutic immunosuppression;therapy development;Vaccination;Vulnerable Populations;Woman

PROJECT_TITLE: Administrative Supplement to Investigate the Effects of Long COVID on SELA study participants

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1(55)-R]


ADMINISTERING_IC: MH

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Anxiety Disorders;Behavioral and Social Science;Brain Disorders;Clinical Research;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Mental Health;Post-Traumatic Stress Disorder (PTSD);Prevention;Racial and Ethnic Minority Health Research;Social Determinants of Health;Violence Against Women;Violence Research;Women's Health Research

ORG_CITY: LA JOLLA

ORG_NAME: UNIVERSITY OF CALIFORNIA, SAN DIEGO

PHR: PROJECT NARRATIVE Women living with HIV, particularly those who are racial and ethnic minority, experience multiple syndemic conditions (e.g., interpersonal violence, adverse mental health, substance use) and socio-structural factors (e.g., intersectional stigma, medical mistrust, discrimination), which may operate as barriers to engagement in HIV care. A key socio-structural factor, structural racism, fuels HIV stigma and medical mistrust within racial and ethnic communities. We proposed to leverage quantitative baseline survey data from participants enrolled in the Women SHINE Study (Grant #R01MH125785; PI: Stockman) to conduct a concurrent mixed methods study examining racial and ethnic differences in structural racism and other socio-structural factors on utilization and retention in HIV care and other ancillary support services among women residing in California.

PI_NAMEs: STOCKMAN, JAMILA KINSHASA (contact)

PROGRAM_OFFICER_NAME: SENN, THERESA ELAINE

PROJECT_TERMS: 2 arm randomized control trial;Address;Adherence;Administrative Supplement;Adult;Affect;Ambulatory Care Facilities;Area;arm;Asian Americans;Baseline Surveys;Black race;California;Caring;cis-female;Communities;Complex;Continuity of Patient Care;coping;Data;Diagnosis;Discrimination;Disparity;Domestic Violence;emotion regulation;Epidemic;ethnic difference;ethnic minority;ethnic minority population;Ethnic Minority Women;Ethnic Origin;Ethnic Population;experience;falls;Focus Groups;Fostering;Goals;Grant;health care service;health inequalities;HIV;HIV diagnosis;improved;Indigenous;Individual;innovation;Institution;interpersonal trauma;Interpersonal Violence;Intervention;Interview;knowledge base;Latina;Link;Logistic Regressions;Measures;Mediator;Medical;medication compliance;member;Mental Health;Methods;minority communities;Modeling;Native Hawaiian or Other Pacific Islander;Online Systems;Outcome;parent grant;Parents;participant enrollment;peer;Post-Traumatic Stress Disorders;Preventive healthcare;Primary Health Care;Process;Public Health;Race;racial difference;racial minority;racial minority population;racial minority women;racial population;racism;Randomized;Recording of previous events;recruit;Research;Research Design;Research Personnel;Role;Sampling Studies;Science;Self Efficacy;Series;Services;social;social stigma;social structure;Social support;Strategic Planning;structural determinants;Structural Racism;substance use;Symptoms;syndemic;System;Testing;Trauma;Underrepresented Populations;Underserved Population;United States;United States National Institutes of Health;Viral;Woman;Women's Health

PROJECT_TITLE: Addressing Trauma from Interpersonal Violence through a Web-based Peer Navigation-Social Support Intervention to Improve ART Adherence among Women


ADMINISTERING_IC: HS

IC_NAME: AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

ORG_CITY: CHICAGO

ORG_NAME: NORTHWESTERN UNIVERSITY AT CHICAGO

ORG_STATE: IL

PHR: Project Narrative Antibiotic overuse is a serious public health crisis and is associated with adverse events including allergic reactions, Clostridioides difficile infection, and antibiotic resistance. New accreditation standards recommend integration of health equity into activities to improve antibiotic prescribing. We propose to conduct a mixed methods study that will evaluate implementation of AS and equity standards and disparities in antibiotic prescribing to close the knowledge gap on understanding drivers of inequity and identify strategies to facilitate equitable antibiotic prescribing in resource-limited settings that treat vulnerable patients.

PI_NAMEs: EVANS, CHARLESNIKA T (contact)

PROGRAM_OFFICER_NAME: MILLER, MELISSA

PROJECT_TITLE: Evaluating equity in antibiotic stewardship and disparities in appropriateness of antibiotic treatment

STUDY_SECTION: HSQR

STUDY_SECTION_NAME: Healthcare Patient Safety and Quality Improvement Research[HSQR]


ADMINISTERING_IC: AG

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Bioengineering;Brain Disorders;Dementia;Neurodegenerative;Neurosciences;Prevention;Stem Cell Research;Stem Cell Research - Induced Pluripotent Stem Cell;Stem Cell Research - Induced Pluripotent Stem Cell - Human

ORG_CITY: MADISON

ORG_NAME: STEM PHARM, INC.

ORG_STATE: WI

PHR: Project Narrative Neuroinflammation is an established component of Alzheimer’s Disease and several immune genes have been identified as risk factors for developing AD. There is currently an unmet need for human model systems which can be used to study this process. Stem Pharm is developing human iPSC derived neural organoids enriched with microglia to model neuroinflammation. This platform will enable testing of immunomodulatory therapeutics and functional interrogation of emerging immune genes in the context of neuroinflammation.

PI_NAMEs: LEBAKKEN, CONNIE S (contact)

PROGRAM_OFFICER_NAME: MARTIN, ZANE

PROJECT_TERMS: abeta oligomer;Alzheimer's Disease;Alzheimer's disease model;Alzheimer's disease risk;American;Amyloid beta-Protein;Apoptotic;Biological Models;Brain;Cells;Data;Dementia;Deposition;drug discovery;Engineering;flexibility;Gene Expression Profile;Generations;Genes;genome wide association study;Human;human induced pluripotent stem cells;human model;Hydrogels;Immune;immune modulating agents;immunoregulation;Inflammation;Inflammation Process;Inflammatory;Late Onset Alzheimer Disease;Macrophage;Measures;Microglia;Modeling;mutant;Mutation;Nerve Degeneration;neural;Neurodegenerative Disorders;Neurofibrillary Tangles;neuroinflammation;neuron loss;Neurons;neuropathology;novel;Organoids;Peptides;phase 2 study;Play;Pluripotent Stem Cells;Population;Process;Reproducibility;response;Risk Factors;risk variant;Rodent Model;Role;screening;Senile Plaques;SPI1 gene;stem;Stimulus;tau Proteins;Technology;Testing;TREM2 gene;Work

PROJECT_TITLE: Human Neural Organoid Modeling of Alzheimer's Disease Neuroinflammation for Drug Discovery


ORG_CITY: BOSTON

ORG_NAME: BRIGHAM AND WOMEN'S HOSPITAL

ORG_STATE: MA

PHR: NARRATIVE VTE is a common public health problem, with up to 600,000 U.S. cases annually resulting in 100,000 deaths, 550,000 hospitalizations, costs of $5-10 billion per year, but with non-specific symptoms making timely detection and subsequent treatment in ambulatory settings challenging. Our team developed an electronic clinical quality measure (eCQM) that uses structured and unstructured EHR data to measure Diagnostic Delay of Venous Thromboembolism (DOVE) in primary care settings and demonstrated rates over 70% across 3 health systems, suggesting an important type of diagnostic error (DE) with likely negative impacts on patient outcomes. This study builds on our prior work by expanding the definition of VTE DE to include both delayed and missed VTE diagnosis, gaining an understanding of VTE DE risk factors, outcomes, disparities, and costs and by developing artificial intelligence and statistical learning tools to identify, factorize, and address vulnerabilities in a range of VTE DE workflows including delayed and missed VTE diagnosis in both primary care and urgent care settings.

PI_NAMEs: CHEN, JIN ;DYKES, PATRICIA C (contact)

PROGRAM_OFFICER_NAME: COSBY, KAREN

PROJECT_TITLE: Complexity, Incidence, and Costs Related to Delayed Diagnosis of Venous Thromboembolism in Urban and Rural Primary and Urgent Care Settings


ED_INST_TYPE: SCHOOLS OF ARTS AND SCIENCES

NIH_SPENDING_CATS: Biotechnology

ORG_CITY: CHAMPAIGN

ORG_DEPT: CHEMISTRY

ORG_NAME: UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN

PHR: Project Narrative This project will investigate new classes of diheme enzymes within a large superfamily that contains proteins predicted to use high-valent bis-FeIV intermediates for tryptophan oxidation. Specifically, it will focus on the formation and stabilization of the bis-FeIV state, as well as the biological use of this potent oxidizing intermediate. The results will elucidate new functions and mechanisms of diheme enzymes.

PI_NAMEs: MANESIS, ANASTASIA  (contact)

PROGRAM_OFFICER_NAME: SIMONOVIC, MILJAN

PROJECT_TITLE: Uncovering novel heme chemistry in microbial systems

STUDY_SECTION: MRAE

STUDY_SECTION_NAME: Maximizing Investigators' Research Award - E Study Section[MRAE]


ADMINISTERING_IC: EY

IC_NAME: NATIONAL EYE INSTITUTE

NIH_SPENDING_CATS: Bioengineering;Clinical Research;Diabetes;Eye Disease and Disorders of Vision;Health Services;Neurosciences;Patient Safety;Prevention

ORG_CITY: ALBUQUERQUE

ORG_NAME: VISIONQUEST BIOMEDICAL INC

ORG_STATE: NM

PHR: Narrative In the United States, diabetic retinopathy (DR) is the most prevalent cause of blindness. Low compliance to DR screening results in vision loss, reduced Medicare payments to insurers, and a $4.3 billion burden to the US due to vision loss treatment, surgery, and diminished productivity. DR-SCRN, a fully automated system, uses diabetic patient’s health data to predict the risk of DR and to educate and notify the patient and its care provider. This addresses a public health need of improving patient’s compliance to routine DR screening, leading to timely intervention, thus potentially preventing vision loss.

PI_NAMEs: JOSHI, VINAYAK S (contact)

PROGRAM_OFFICER_NAME: LEE, PAEK-GYU

PROJECT_TERMS: Address;Algorithms;automated algorithm;Awareness;Blindness;care providers;Clinic;Clinical Research;Computer software;Data;Data Set;Databases;Diabetes Mellitus;diabetic;diabetic patient;Diabetic Retinopathy;Early Diagnosis;Educational Materials;Electronic Health Record;electronic health record system;Future;Grant;Health;health data;improved;innovation;Insurance Carriers;Intervention;Knowledge;longitudinal database;Measures;Medicare;Mexico;Motivation;Notification;Operative Surgical Procedures;ophthalmic examination;Patient Compliance;Patient Education;Patient risk;patient screening;Patient Selection;Patients;payment;Periodicals;Phase;Population;prevent;Productivity;prototype;Provider;Public Health;Recommendation;Retina;Risk;risk prediction;Schedule;screening;screening guidelines;Screening Result;software development;success;Symptoms;System;tool;trend;United States;Validation;Visual

PROJECT_TITLE: Automated system to improve compliance to diabetic retinopathy screening


ADMINISTERING_IC: CA

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Cancer;Digestive Diseases;Pancreatic Cancer;Prevention;Rare Diseases

ORG_CITY: WEST LAFAYETTE

ORG_NAME: AMPLIFIED SCIENCES INC

ORG_STATE: IN

PHR: 2. I-Corps Team The I-Corps team will be formed with three key members of the leadership team. The team has actively been involved in product development and is currently building commercialization strategies for the launch of this assay via a targeted “early access” launch in 2025. All team members have previous experience with startups in the life science industry. Members also have commercial launch, market research, and diagnostics industry experience which will allow the team to effectively carry out the requirements of the I-Corps grant. The Corporate Officer representative will be Diana Caldwell, CEO, who is an accomplished and recognized serial life science entrepreneur with over 25 years of experience in both large corporate and small entrepreneurial environments. Throughout her career, she has successfully driven organizational growth, developed, and implemented strategic business plans, raised capital, launched novel life science products, and directed successful teams. Diana has been leading Amplified Sciences for three years, has decades of life science product launch experience, and has in-depth knowledge of the technologies and the markets that we will be addressing in carrying out the objections of the I-Corps grant. Dan Sheik, PhD, Director of Research and Technology at Amplified Sciences, is the PI on this working to improve the diagnostic sensitivity of assays using proprietary rhodamine dyes and the ultrasensitive Surface- on early detection of pancreatic cancer to improve the quantitative resolution of biomarkers to give a clearer picture of pancreatic cyst malignancy. Dan’s assay development experience and scientific skills provide the project with the technical expertise that will be necessary to meet the objectives of the I-Corps grant. John R. Ridge will round out the team as the Industry Expert. John joined Amplified Sciences as 20 years of experience working in Market Access and cross functionally with commercial functions for Medical Device and Diagnostics companies. Additionally, he worked on the payer side early in his career thus bringing a well rounded industry perspective to the challenges and opportunities in successful commercial launch and reimbursement efforts. Before joining Amplified Sciences as an employee, he served as an Advisor for the company and is familiar with the company’s new technologies and will use that knowledge and prior diagnostic product launch experience to contribute effectively to the team’s efforts. The I-Corps grant will be valuable to the team as it will allow us to further build on initial research that was completed by student interns. That project identified potential key targets that we could reach out to with the discovery questions, and that would allow us to gain key data to assess customer needs, understand commercial adoption barriers, explore the value this innovation provides, and develop potential options to position the new assay. All team members will be able to meet the time intensive time requirements outlined in the program. This proposed team is also able to benefit maximally from the I-Corps program as it has already conducted background research into competitive IP landscape, competitors’ publications, customer needs, value proposition, market assessment and reimbursement models. With new knowledge and information gained from the I-Corps program, the team is capable of and looks forward to a thorough vetting from potential customers and industry experts of these early concepts and refining, realigning and/or pivoting their initial plan to maximize commercialization success. 3. Potential Commercial Impact and Target Customers Research indicates that the pancreatic cancer diagnostics US market is a robust +$2.9 billion (TAM). Over 3 million patients are diagnosed annually in the US with a pancreatic cyst, and it is -FNA procedure to sample cyst fluid. A conservative estimate of ~300,000 patients tested annually yields a serviceable available market (SAM) of at least $300 million in the US. Amplified Sciences’ sales revenue for the rule-in high-grade vs. low- grade assay forecast at $80 million five years post launch. This represents 20,000 tests and a 20- 25% market share. The proposed customers would be centers of specialty gastroenterologists (30-50), advanced/interventional endoscopists, specialty fellows, pancreatic cyst clinics, and high-risk pancreatic cancer centers. Within this market, there is a large unmet medical need for earlier detection of pancreatic cancer given that it is the third deadliest cancer with the highest mortality rate in the US. Patients diagnosed with pancreatic cystic lesions are at increased risk for pancreatic cancer and represent a window to early detection, and monitoring and surgery on these patients is expensive and associated with complications and morbidity. One of our specific plans for the I-Corps program is to conduct interviews with the customer targets and influencers. Clinician influencers include pancreatic biliary surgeons, oncologists, and hospital pathologists. Although the customer physician targets are clear, there are also key decision makers with commercial and government payers. Their role is to determine if a new novel assay should be covered and paid when a bill is submitted for a lab developed test by the diagnostic company. In the commercialization of a new assay, it is critically important to assess payers’ thoughts and gain their inputs on the clinical value of the assay. As such, they will need to be a target of the project as well. In addition, there is no current standard testing for grading dysplasia, with multiple attempts showing little promise. In fact, peer reviewed studies have demonstrated that standard cytology fails over 70% of the time in this disease state due to acellularity of the cyst fluid sample and the low volume of fluid that is successfully procured during an EUS-FNA. Given the lack of laboratory- based solutions, clinicians and payers are very receptive to novel diagnostics with increased sensitivity and specificity vs. currently available diagnostic competitors that can provide improved outcomes and cost savings. A competitive advantage rests in our ability to provide clinicians access to an assay that delivers higher content diagnostic information about the malignant potential of the mucinous pancreatic cyst population. By analyzing competitors and similar lab developed test models across other cancers, a target price range between $2000 - $3000 has been established but needs to be confirmed. This price point has been established considering several factors: material and production cost, reimbursement of similar assays, and likelihood to be able to cross-walk to an existing test in a different disease state. It is important to note that the price point is sensitive to the assay reimbursement rate that would be determined by the Centers for Medicare and Medicaid Services or the Medicare Administrative Contractors. We are open to revisiting these additional factors and possibly revising this price point based on interviews with a much larger pool of stakeholders of the assay. 4. Project Plan - readiness, and adaptability to standard clinical lab test processes. Amplified Sciences seeks to -certified lab that are novel and demonstrate superior accuracy with a keen desire to stretch the capabilities and acceptance of SERS as a detection platform. These efforts to validate biomarkers of dysplasia in mucinous pancreatic cysts in this Phase 1 are expected to produce assays that have demonstrated clinical proof of concept in a small retrospective cohort. These assays will be ready for further analytical validation and larger hypothesis, Amplified Sciences will use the protocols developed in AIM 2 to reanalyze the 100 clinical samples from AIM 1 and compare the diagnostic results after optimization with a second nested-cross validation study to those of AIM 1. It is expected that the results using Amplified Sciences’ assay platform will prove to be at least non-inferior to the results found in the AIM 1 validation studies. Importantly, the new assays will use low sample volumes, allowing for the multi-analyte panel to be tested on -volume analyses prevent interruption of current standards of care while this panel is introduced to the clinic. Currently we are continuing optimization of marker assays to our SERS platform before final clinical sample testing. This is expected to be completed prior to submission of our Phase II application. Assuming that these results are promising, the company is prepared to execute the -certified lab in Irvine, California. The company will execute the analytical validation and clinical validation protocols required to regulatory milestone, the company will prepare for a targeted early-access launch to advanced endoscopist gastroenterologists targeted by the end of 2025. Phase II will combine a set of multiplexed low-volume assays ready to commercialize as lab -site prospective sample (n = 300) collection study.

PI_NAMEs: SHEIK, DANIEL  (contact)

PROGRAM_OFFICER_NAME: LOU, XING-JIAN

PROJECT_TERMS: accurate diagnostics;activity marker;Address;Adoption;algorithm development;assay development;Benign;Biliary;Biochemical;Biological Assay;Biological Markers;Biological Sciences;biomarker validation;Businesses;California;Cancer Center;Cancer Diagnostics;Capital;career;Caring;Certification;Chemicals;Clinic;Clinical;clinical diagnostics;Clinical Investigator;clinical translation;cohort;Collection;commercial launch;commercialization;Contractor;cost;Cost Savings;Cyst;Cyst Fluid;Cytology;Data;Death Rate;Detection;detection method;detection platform;Diagnosis;Diagnostic;diagnostic assay;Diagnostic Sensitivity;Diagnostic tests;diagnostic value;Disease;Doctor of Philosophy;Dyes;Dysplasia;Early Diagnosis;Employee;Environment;Evaluation;experience;Fine needle aspiration biopsy;Funding;Gastroenterologist;Government;Grant;Growth;high risk;Hospitals;Image;improved;improved outcome;Industry;innovation;Innovation Corps;insight;Internships;Interruption;Intervention;Interview;Knowledge;Laboratories;Leadership;Ligand Binding;Liquid substance;Malignant - descriptor;Malignant neoplasm of pancreas;Malignant Neoplasms;Market Research;Marketing;Medical;Medical Device;medical specialties;Medicare;member;Modeling;Monitor;Morbidity - disease rate;Mucinous;new technology;novel;novel diagnostics;Oncologist;Operative Surgical Procedures;Pancreas;Pancreatic Cyst;Pancreatic cystic neoplasia;Pathologist;patient stratification;Patients;Peer Review;Peptide Hydrolases;Phase;Physicians;Population;Positioning Attribute;prevent;Price;Procedures;Process;product development;Production;programs;progression risk;prospective;Protocols documentation;prototype;Publications;Readiness;Research;research clinical testing;Resolution;Rest;Retrospective cohort;Rhodamine;Risk;risk stratification;Role;routine imaging;Sales;Sampling;Science;Screening procedure;Secure;Sensitivity and Specificity;Side;Site;skills;Small Business Innovation Research Grant;Statistical Data Interpretation;Stretching;Students;success;supply chain;Surface;Surgeon;Survival Rate;Technical Expertise;Technology;Testing;Thinking;Time;Translating;United States Centers for Medicare and Medicaid Services;Validation;validation studies;Vendor;Visit;Walking;Work

PROJECT_TITLE: Translating a Novel Assay for Risk Stratification of Potentially Malignant Pancreatic Cystic Lesions


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Bioengineering;Emerging Infectious Diseases;Infectious Diseases;Lung;Rare Diseases;Tuberculosis

ORG_CITY: Seattle

ORG_NAME: TRULY TECHNOLOGIES LLC

ORG_STATE: WA

PHR: PROJECT NARRATIVE Current diagnostic methods for tuberculosis (TB) either require sputum, take days to weeks to return results, or require high cost equipment that is not available in low-resource areas where TB is endemic. Lateral flow assays (LFAs) to test urine for TB exist; however, they are too low-sensitivity to be approved for clinical use due to low-concentrations of TB biomarkers in urine. OsmoProcessor is currently producing prototypes for a device which can rapidly concentrate urine samples and interface with LFAs without a power-source or special equipment, enabling a potential standardized point-of-care diagnostic for TB.

PI_NAMEs: LAI, JAMES  (contact)

PROGRAM_OFFICER_NAME: LACOURCIERE, KAREN A

PROJECT_TERMS: 2019-nCoV;Address;Affect;Antigens;Area;Award;Biological Assay;Biological Markers;Buffers;Businesses;Centrifugation;Cessation of life;Clinical;Collaborations;Collection;commercialization;cost;Data;design;Detection;detection limit;Devices;Diagnosis;Diagnostic;diagnostic biomarker;Diagnostic Procedure;diagnostic value;Diffusion;Disease;Enzyme-Linked Immunosorbent Assay;Equation;Equipment;Excision;Exhibits;experience;flexibility;Grant;Healthcare;Human;Human Chorionic Gonadotropin;Immunoassay;improved;Individual;Industry;infection risk;innovation;Interview;Kinetics;Laboratories;lateral flow assay;Letters;lipoarabinomannan;Mainstreaming;manufacturing scale-up;Marketing;Mass Spectrum Analysis;Measures;Membrane;Methods;Microscopy;Modeling;Monitor;mycobacterial;Noise;Nucleic Acid Amplification Tests;Nucleocapsid Proteins;Osmosis;Performance;Persons;Phase;point of care;point of care testing;point-of-care diagnostics;Polymers;Power Sources;Preparation;prevent;Procedures;Process;Production;Proteins;prototype;Recovery;Research;Resource-limited setting;Risk;Sampling;scale up;Scientist;Signal Transduction;Small Business Innovation Research Grant;small molecule;Solubility;South Africa;Special Equipment;Specimen;Speed;Sputum;Standardization;success;Surface;Temperature;Testing;Therapeutic;Time;Training;Tuberculosis;tuberculosis diagnostics;tuberculosis treatment;Ultracentrifugation;Ultrafiltration;Urea;Urea Nitrogen;urinary;Urine;With laterality

PROJECT_TITLE: Enabling standardized point-of-care tuberculosis diagnostics via rapid osmotic concentration


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Brain Disorders;Dementia;Genetics;Neurodegenerative;Neurosciences

ORG_CITY: La Jolla

ORG_NAME: SALK INSTITUTE FOR BIOLOGICAL STUDIES

PHR: PROJECT NARRATIVE The parent project aims at deciphering the roles of age-related aberrant PKM2 and neuronal hypo-maturity in Alzheimer’s disease (AD) using patient-specific induced neurons (iNs). The team will study the spatial relationship between neuronal PKM2 and markers for neuronal senescence, neurodegeneration and neuroinflammation in brain sections from AD patients, and employ functional and unbiased multi-omic approaches to study the functional impact of engineered PKM2/1 imbalance in vital human iNs. They will also leverage insights from the cancer field and explore chemical PKM modulators in AD patient iNs to develop novel approaches to treat AD, and they will assess the impact of aberrant metabolic states of aged human neurons in the context of neuron-astrocyte coupling in a three-dimensional multicellular model based on age- equivalent iNs.

PI_NAMEs: GAGE, FRED H (contact)

PROGRAM_OFFICER_NAME: DIBATTISTA, AMANDA

PROJECT_TERMS: 3-Dimensional;abeta deposition;Address;Adult;Affect;Age;age related;aged;Aging;aging related;Alleles;Alzheimer's Disease;Alzheimer's disease brain;Alzheimer's disease patient;anti-cancer research;Antineoplastic Agents;Apolipoprotein E;apolipoprotein E-4;Astrocytes;Autopsy;base editing;Biological Assay;Brain;Buffers;cancer cell;Cell Aging;Cell model;Cell Nucleus;cell type;Cells;Central Nervous System;Chemicals;Clinical;Clustered Regularly Interspaced Short Palindromic Repeats;Coculture Techniques;Complement;Coupling;Cytoplasm;Data;Defect;Disease;Disease Marker;disease phenotype;Disease Progression;drug development;drug discovery;Effectiveness;Elderly;Engineering;Environment;Epigenetic Process;Etiology;Exhibits;Gene Expression;Genes;Genetic;Goals;Haplotypes;Human;Impairment;Individual;Induced Neurons;induced pluripotent stem cell;Inflammation;Inflammatory;injured;insight;Knowledge;Lead;lipid metabolism;lipidomics;Macrophage;Malignant Neoplasms;Metabolic;metabolic abnormality assessment;Metabolism;metabolomics;Microglia;Mitochondria;Molecular;multiple omics;Natural Compound;Nerve Degeneration;Nervous System;Neurodegenerative Disorders;Neuroglia;neuroinflammation;Neuronal Dysfunction;Neurons;Neurosciences;novel strategies;Nuclear;Oncogenic;Onset of illness;Organoids;paracrine;Paraffin;parent project;pathogen;Pathogenesis;Pathologic;Pathology;Pathway interactions;Patients;Persons;Phosphorylation;postmitotic;programs;Property;Protein Isoforms;Proteins;Proteomics;Protocols documentation;Reaction;Rejuvenation;RNA Splicing;Role;Scientific Advances and Accomplishments;senescence;single-cell RNA sequencing;spatial relationship;Stimulus;Structure;Synapses;tau Proteins;Testing;Therapeutic;Tissues;Toxic effect;transcriptome;transcriptome sequencing;Transgenic Organisms;Variant;Warburg Effect

PROJECT_TITLE: Assessing cellular aging in old and rejuvenated neurons from Alzheimer patients


NIH_SPENDING_CATS: Aging;Microbiome;Nutrition;Osteoporosis

ORG_CITY: SAN FRANCISCO

ORG_DEPT: ORTHOPEDICS

ORG_NAME: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

PHR: 8. PROJECT NARRATIVE The long term goal of this work is to prevent age- and osteoporosis-related fractures. In this project we study how the microbiome (bacteria living in the body) influence bone strength. The work has the potential to lead to new treatments to prevent osteoporosis-related fractures.

PI_NAMEs: HERNANDEZ, CHRISTOPHER JOHN (contact)

PROGRAM_OFFICER_NAME: FLORES, ROBERTO L

PROJECT_TERMS: Activities of Daily Living;Address;Adult;Age;aged;Animals;Antibiotics;Bacteria;Binding;Biochemical;Biomechanics;bone;Bone Density;bone fragility;bone loss;bone mass;Bone Matrix;bone quality;bone strength;Bone Tissue;Chemicals;density;Dependence;Development;Diagnostic;Disease;Estrogens;experimental study;fracture risk;Genes;Genetic;Geometry;Germ-Free;Gnotobiotic;Goals;Growth;gut microbiome;gut microbiota;Human;Impairment;improved;Individual;Knock-out;life span;Link;mature animal;Measures;Mechanics;Metagenomics;Microbe;microbial;microbial community;Microbial Genetics;Microbial Taxonomy;microbiome;microbiome research;microbiome therapeutics;microbiota;Minerals;Modification;Mus;nanoscale;novel;Organ;Organism;Orthologous Gene;Osteocalcin;Osteoporosis prevention;osteoporosis with pathological fracture;Pathway interactions;Performance;Phenotype;Phylogeny;preclinical study;pregnane X receptor;prevent;Process;Production;Proteins;Regulation;Reporting;Role;side effect;skeletal;Skeleton;SXR receptor;targeted treatment;Taxonomy;Testing;Time;Tissues;Vitamin K;Work

PROJECT_TITLE: Supplement to Microbiome and Bone Strength

STUDY_SECTION: SBSR

STUDY_SECTION_NAME: Skeletal Biology Structure and Regeneration Study Section[SBSR]


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Anxiety Disorders;Behavioral and Social Science;Brain Disorders;Cardiovascular;Clinical Research;Clinical Trials and Supportive Activities;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Mental Health;Mental Illness;Post-Traumatic Stress Disorder (PTSD);Prevention;Social Determinants of Health

ORG_CITY: Fort Lauderdale-Davie

ORG_NAME: NOVA SOUTHEASTERN UNIVERSITY

ORG_STATE: FL

PHR: Project Narrative. The candidate, Ms. Alexis Tola, is a first year PhD student. She is motivated to engage in an academic research career, with a focus on cardiovascular health aspects of PTSD, and was recruited as a primary PhD mentee of the project PI. Ms. Tola is of Hispanic minority status (Ecuadorian). Her interests and objectives related to the parent project (outlined in the aims and hypotheses below) include the relationship of stress levels, socioeconomic status, and PTSD severity to CVD risks and the intervention outcomes, as well as the relationships of medication use to the intervention outcomes.

PI_NAMEs: KIBLER, JEFFREY L. (contact)

PROGRAM_OFFICER_NAME: CAMPO, REBECCA A

PROJECT_TERMS: Behavioral;cardiovascular health;cardiovascular risk factor;career;Cognitive;Doctor of Philosophy;doctoral student;Ecuadorian;Health;healthy lifestyle;Hispanic;interest;Intervention;Knowledge;lifestyle intervention;Mediating;Minority Status;Outcome;parent project;Parents;Pharmaceutical Preparations;Post-Traumatic Stress Disorders;recruit;Research;Risk;Risk Reduction;Role;Sampling;Severities;sociodemographic factors;Socioeconomic Status;Stress

PROJECT_TITLE: The Effects of a Cognitive Behavioral Healthy Lifestyle Intervention for Cardiovascular Risk Reduction in Posttraumatic Stress Disorder


NIH_SPENDING_CATS: Aging;Atherosclerosis;Basic Behavioral and Social Science;Behavioral and Social Science;Brain Disorders;Cardiovascular;Clinical Research;Depression;Dissemination and Implementation Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Mental Health;Prevention;Racial and Ethnic Minority Health Research;Social Determinants of Health;Violence Research

PHR: PROJECT NARRATIVE The objective of the parent R01 Mediators of Atherosclerosis in South Asians Living in American (MASALA) study is to identify how socio-cultural context, discrimination, acculturation strategies and resilience resources act as risk or protective factors explaining cardiovascular health disparities in Indian, Pakistani and Bangladeshi immigrants. The proposed diversity supplement application will enhance the parent grant using life history interviews to gain an in-depth understanding of the lived experiences of participants, and how historical and contemporary trauma has shaped their health status. A storytelling workshop and community forum to share these stories will be used to assess the feasibility and acceptability of storytelling as a mental health intervention.

PI_NAMEs: ISLAM, NADIA S;KANAYA, ALKA M. (contact);KANDULA, NAMRATHA R

PROGRAM_OFFICER_NAME: JOSEPH, SUSAN KALAPURA

PROJECT_TERMS: acceptability and feasibility;Acculturation;American;Asia;Asian Indian;Atherosclerosis;Bangladesh;Bangladeshi;Behavior;Behavioral;British;Businesses;Cardiovascular Diseases;cardiovascular health;Cessation of life;Cholesterol;cohesion;cohort;Communities;Country;Creativeness;Data;depressive symptoms;Diabetes Mellitus;Diet;Discrimination;Distress;Dyslipidemias;Economics;Educational workshop;Emotional;Enrollment;Ethnic Population;Event;experience;Family dynamics;girls;Goals;health disparity;Health Status;Home;Hypertension;Immigrant;Immigration;India;insight;intergenerational;Intervention;Interview;Learning;lens;Life;life history;Lived experience;Longitudinal cohort study;Longitudinal Studies;low socioeconomic status;Measures;Mediating;Mediator;Mental Health;Methodology;migration;Modeling;National Institute on Minority Health and Health Disparities;Non-Insulin-Dependent Diabetes Mellitus;Obesity;Pakistan;parent grant;parent project;Parents;Participant;participant interview;Persons;Physical activity;poor health outcome;Population;protective factors;public health intervention;racial population;Reach, Effectiveness, Adoption, Implementation, and Maintenance;Research;Research Activity;resilience;Resources;Risk Factors;Role;Sampling;Seminal;sexual violence;Shapes;social;social culture;Socioeconomic Status;Source;South Asian;Structure;Subgroup;Surveys;Symptoms;Testing;Tobacco use;transmission process;Trauma;United States;Violence;War;Woman

PROJECT_TITLE: Understanding health disparities in Pakistani, Bangladeshi and Asian Indian immigrants: the role of socio-cultural context, acculturation and resilience resources - Supplement

STUDY_SECTION: CIHB

STUDY_SECTION_NAME: Community Influences on Health Behavior Study Section[CIHB]


FUNDING_MECHANISM: TRAINING, INDIVIDUAL

NIH_SPENDING_CATS: Genetics;Hematology;Rare Diseases;Stem Cell Research;Stem Cell Research - Nonembryonic - Human

ORG_CITY: NEW YORK

ORG_NAME: NEW YORK UNIVERSITY SCHOOL OF MEDICINE

PHR: PROJECT NARRATIVE This proposal will directly address a fundamental question concerning the mechanism of disease in VEXAS syndrome, a newly described clonal bone marrow and inflammatory disorder. I anticipate that this study will not only identify molecular targets for the treatment of VEXAS but will also further our understanding of key cellular ubiquitylation processes, autoinflammatory disease, and bone marrow-derived disease.

PI_NAMEs: MAGAZINER, SAMUEL JAMES (contact)

PROGRAM_OFFICER_NAME: GILLASPY, ALLISON

PROJECT_TERMS: Ablation;Accounting;Address;Adrenal Cortex Hormones;Affect;Age;autoinflammatory;autoinflammatory diseases;Automobile Driving;Biological;Biological Models;Bone Marrow;Bone Marrow Diseases;Cell Culture Techniques;Cell Death;Cell Line;Cell model;Cells;Charge;Chinese Hamster;Clonal Expansion;Clonal Hematopoietic Stem Cell;Complementary DNA;cytokine;Cytoplasm;Data;Death Rate;Defect;Degradation Pathway;Disease;Disease Progression;Disparate;Dose;Dysmyelopoietic Syndromes;Elderly;Endoplasmic Reticulum;Enzymes;Future;Genes;Health;Hematological Disease;Hematology;Hematopoietic stem cells;Homeostasis;Human;Immune;Inflammation;Inflammatory;Investigation;Link;Lymphocyte;male;Malignant Neoplasms;Mediating;men;Methionine;Modeling;Molecular Target;molecular targeted therapies;monocyte;mutant;Mutation;Myelogenous;Myeloid Cells;Neurodegenerative Disorders;novel;Nuclear;Ovary;Pancytopenia;Pathogenesis;Pathway interactions;Patients;Phenotype;Process;Protein Isoforms;Proteins;Proteomics;Regulation;Relapsing polychondritis;Residual state;response;Role;Site;small hairpin RNA;small molecule;small molecule inhibitor;Somatic Mutation;Syndrome;Temperature;Testing;Therapeutic;Therapeutic Intervention;transcriptomics;Transgenic Organisms;Translating;Translations;U937 Cells;UBE2G2 gene;ubiquitin ligase;Ubiquitin-Activating Enzymes;Ubiquitin-Conjugating Enzymes;ubiquitin-protein ligase;Vacuole;Validation;Vasculitis;X Chromosome

PROJECT_TITLE: Elucidation of the mechanism of disease of VEXAS Syndrome


NIH_SPENDING_CATS: Bioengineering;Drug Abuse (NIDA only);Opioid Misuse and Addiction;Opioids;Physical Injury - Accidents and Adverse Effects;Substance Misuse

ORG_CITY: THOUSAND OAKS

ORG_NAME: ACTIOX LLC

PHR: Our proposed SBIR wearable device focuses on the continuous monitoring of methadone levels in patients, offering real-time feedback to healthcare professionals. Using minimally invasive microneedle technology, the device provides personalized and accurate methadone dosing, reducing the risk of overdose and mitigating opioid use disorder. The device is designed to advance the field of precision medicine by providing continuous biochemical monitoring of methadone levels, allowing for real-time adjustments to the therapeutic drug dosage based on the patient's individual physiology. Our commitment to excellence and integrity in developing and bringing this innovative technology to market is unwavering, with the potential to significantly improve the lives of those suffering from opioid use disorder.

PI_NAMEs: TEHRANI, FARSHAD  (contact)

PROGRAM_OFFICER_NAME: KOSTOV, YORDAN VALTCHOV

PROJECT_TERMS: Address;Adult;Animals;Architecture;automobile accident;Biochemical;Cause of Death;Centers for Disease Control and Prevention (U.S.);Cessation of life;Chemicals;Clinical Research;COVID-19;design;Development;Devices;dosage;Dose;Electronics;Ensure;falls;Feasibility Studies;Feedback;Fentanyl;Health Care Costs;Health Personnel;Health Professional;human subject;improved;In Vitro;individual patient;innovation;innovative technologies;Intercellular Fluid;Life;Malignant Neoplasms;Marketing;Methadone;minimally invasive;Modification;Monitor;monitoring device;Needles;operation;opioid overdose;opioid use disorder;Overdose;overdose risk;Patients;Performance;Pharmaceutical Preparations;Phase;Physiology;Population;precision medicine;psychostimulant;Public Health;Quality of life;Relapse;relapse prevention;Reproducibility;Risk Reduction;Sampling;sensor;Serum;Skin;Small Business Innovation Research Grant;statistics;Suicide;Surface;synthetic opioid;Technology;Therapeutic;Time;wearable device

PROJECT_TITLE: A wearable Device for Continuous Monitoring of Methadone


FUNDING_MECHANISM: OTHER RESEARCH-RELATED

NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Clinical Research;Disability Research;Hematology;Pain Research;Physical Activity;Physical Rehabilitation;Prevention;Rare Diseases;Rehabilitation;Sickle Cell Disease

ORG_CITY: DURHAM

ORG_NAME: DUKE UNIVERSITY

ORG_STATE: NC

PHR: Project Narrative The life expectancy for individuals with sickle cell disease has improved substantially over the last 50 years; however, there are no validated methods for assessing capabilities and vulnerabilities in this aging population. The goal of this study is to evaluate the validity and reliability of the Sickle Cell Disease Functional Assessment and pilot an exercise intervention for older adults with sickle cell disease. This research will contribute by improving knowledge about management of older adults with sickle cell disease and will provide preliminary data for interventions to ameliorate functional impairment and improve longevity.

PI_NAMEs: OYEDEJI, CHARITY IBILOLA (contact)

PROGRAM_OFFICER_NAME: ZOU, SHIMIAN

PROJECT_TERMS: acceptability and feasibility;Activities of Daily Living;Address;Adult;Aerobic;Age;age related changes;aging population;aging process;Assessment tool;career;career development;Cell Aging;Cessation of life;Clinic Visits;Clinical;Cognition;cognitive function;cohort;comorbidity;Coupled;Data;Dependence;design;Development;Development Plans;Dimensions;disability;Early identification;Educational Intervention;Elderly;Emergency department visit;Emergency Situation;Enrollment;Equilibrium;Exercise;exercise intervention;exercise program;exercise training;experience;Failure;Fatigue;Focus Groups;follow-up;Foundations;frailty;functional decline;Functional dependence;Functional impairment;functional improvement;Funding;Future;Geriatric Assessment;Geriatrics;global health;Goals;Health;health assessment;health care service utilization;Health Promotion;Health Status;Hematology;Hospitalization;Impaired cognition;Impairment;improved;Individual;Information Systems;instrumental activity of daily living;Intervention;K-Series Research Career Programs;Knowledge;Length of Stay;Life Expectancy;Longevity;low socioeconomic status;Measurement;Measures;Medical;Medicine;Mentors;Mentorship;Methods;modifiable risk;mortality;Necrosis;Nutritional status;older adult;Oncology;Outcome;Pain;Pain intensity;Pain interference;Participant;Patient Outcomes Assessments;Patients;Persons;Pharmaceutical Preparations;Physical assessment;physical conditioning;Physical Function;physical impairment;Physical Performance;Pilot Projects;Population;premature;prevent;primary outcome;Process;professor;programs;Property;Prospective cohort;psychologic;Psychometrics;Psychosocial Assessment and Care;Pulmonary Heart Disease;Quality of life;Randomized, Controlled Trials;Regression Analysis;Research;Research Personnel;Risk Factors;secondary outcome;Sensory;Sickle Cell;Sickle Cell Anemia;skills;Sleep;social;Social Functioning;Social support;Stroke;success;Surveys;Testing;therapy development;Time;Training Programs;Universities;Validation;Validity and Reliability;virtual;Visit;Walking;Work

PROJECT_TITLE: Sickle Cell Disease Functional Assessment Validation and Exercise Pilot Intervention


FUNDING_MECHANISM: NON SBIR/STTR CONTRACTS

NIH_SPENDING_CATS: Cancer

ORG_CITY: ROCKVILLE

ORG_NAME: FISHER BIOSERVICES, INC.

PI_NAMEs: LEE, MARK  (contact)

PROJECT_TERMS: absorption;Agreement;analytical method;anti-cancer;Archives;Area;Argon;Asia;Atmosphere;atmospheric conditions;Australia;Authorization documentation;Biological;Biological Products;chemical association;Chemical Structure;Chemicals;chemotherapeutic agent;Compact discs;Computer Security;computerized;Computers;Confidential Information;Contractor;Contracts;cost;Country;Cream;cyber security;Cyclic GMP;Data;Databases;Development;Developmental Therapeutics Program;Devices;Dimethyl Sulfoxide;Disclosure;Division of Cancer Treatment and Diagnosis;Documentation;drug synthesis;Dry Ice;Electronics;Elements;Emergency Situation;Employee;encryption;Environment;Equipment;Equipment and supply inventories;Ethics;Europe;Evaluation;Event;Extramural Activities;Federal Government;Film;Fire - disasters;firewall;flexibility;Generations;Goals;Government;Government regulations;Guidelines;Hazardous Substances;Human Resources;Humidity;In Vitro;in vivo evaluation;Industry Standard;Infrastructure;Institution;interest;International;Label;Laboratories;laboratory equipment;laptop;Laws;Legal;Libraries;Light;liquid chromatography mass spectrometry;Local Government;Malignant Neoplasms;Manuals;Memory;Methods;Mission;Monitor;Mothers;National Cancer Institute;National Center for Advancing Translational Sciences;National Institute of Allergy and Infectious Disease;Natural Products;Nitrogen;Non-Prescription Drugs;Notification;operation;Performance;Pharmaceutical Preparations;Police;Policies;pre-clinical;Preclinical Drug Evaluation;Procedures;Process;Program Evaluation;programs;Property;Recommendation;Recording of previous events;Records;Refuse Disposal;Regulation;repository;Research;Research Personnel;Robotics;Safety;Sampling;screening;Security;Security Measures;Services;Shipping;small molecule;small molecule therapeutics;Solvents;Specific qualifier value;State Government;Structure;System;Techniques;Temperature;Testing;Therapeutic Agents;Time;Training;United States National Institutes of Health;Update;ventilation;Virus;Water;web site;Work;Writing

PROJECT_TITLE: REGISTRATION, STORAGE AND DISTRIBUTION OF CHEMICALS AND DRUGS FOR PRE-CLINICAL DISCOVERY EVALUATION AND DEVELOPMENT


ORG_CITY: MCLEAN

ORG_STATE: VA

PI_NAMEs: GHALEB, GHALEB  (contact)

PROJECT_TITLE: BASE IDIQ TITLE: TECHNICAL, PROGRAMMATIC AND OTHER SUPPORT SERVICES TO THE NCI CSSI.TASK ORDER TITLE: NCI OCCPR WEBSITE MAINTENANCE


NIH_SPENDING_CATS: Antimicrobial Resistance;Emerging Infectious Diseases;Genetics;Infectious Diseases;Lung;Pneumonia;Pneumonia and Influenza

ORG_CITY: Newark

ORG_DEPT: MICROBIOLOGY/IMMUN/VIROLOGY

ORG_NAME: RUTGERS BIOMEDICAL AND HEALTH SCIENCES

ORG_STATE: NJ

PHR: Project narrative Klebsiella pneumoniae (Kp) ST258 is a major cause of morbidity and mortality in clinical settings owing to its multidrug resistance. Despite ongoing research efforts, there is still a lack of understanding for its success outside antimicrobial resistance strategies. The goal of this work is to understand how the host immunometabolic response to Kp ST258 promotes persistent infection by driving both immunosuppression and bacterial adaptation.

PI_NAMEs: WONG FOK LUNG, TANIA  (contact)

PROGRAM_OFFICER_NAME: ESPINOZA-PINTUCCI, MARISOL

PROJECT_TERMS: Acute;Address;Anti-Inflammatory Agents;Antibiotic Resistance;Antimicrobial Resistance;Area;Automobile Driving;Bacteria;Bacterial Genes;Bacterial Infections;biological adaptation to stress;carbapenem resistance;Career Choice;Cells;Chemicals;Chronic;chronic infection;Clinical;COVID-19 pandemic;cytokine;Development;Effector Cell;Failure;fatty acid oxidation;Flow Cytometry;Foundations;Future;Gene Expression;Generations;Genes;Genetic;Genetic Transcription;Genomics;Global Change;Glucose;Goals;Homeostasis;Hospitals;Image;Immune;immune function;Immune response;Immunosuppression;In Vitro;Indolent;Infection;Inflammatory;inflammatory marker;Inflammatory Response;inhibitor;Investigation;Klebsiella Infections;Klebsiella pneumoniae;Knockout Mice;Knowledge;Light;Lung;Lung infections;Macrophage;Medicine;Metabolic;Metabolic Activation;Metabolic Pathway;Metabolic stress;Metabolism;metabolome;metabolomics;Molecular;monocyte;Morbidity - disease rate;mortality;Multi-Drug Resistance;Mus;mutant;Myeloid-derived suppressor cells;neoplastic cell;New York;Nosocomial pneumonia;novel strategies;Outcome;Oxidation-Reduction;Oxidative Phosphorylation;Oxidative Stress;pathogen;Pathogenesis;Pathway interactions;Pattern;pediatric department;permissiveness;premature;Presbyterian Church;prevent;Production;programs;Proliferating;Property;Proteomics;Public Health;Quantitative Reverse Transcriptase PCR;Reactive Oxygen Species;recruit;Regulatory T-Lymphocyte;Research;research study;resistant Klebsiella pneumoniae;response;SARS-CoV-2 infection;Signal Transduction;single-cell RNA sequencing;Structure of parenchyma of lung;success;Surface;System;Techniques;Testing;Therapeutic;Therapeutic Agents;therapeutically effective;Time;transcriptome sequencing;transcriptomics;tumor;tumor eradication;tumor growth;tumor metabolism;Tumor Promotion;tumorigenesis;Universities;Up-Regulation;ventilator-associated pneumonia;Vision;Work

PROJECT_TITLE: Understanding the immunometabolic response to Klebsiella pneumonia infection

STUDY_SECTION: NSS

STUDY_SECTION_NAME: NSS


PHR: Project Narrative Hospitals routinely place patients infected with Clostridioides difficile, the most common cause of healthcare- associated infections in the US, on “contact precautions” to prevent in hospital transmission, but it is unknown if this infection prevention intervention is necessary for patients with C. difficile colonization. We propose to determine if contact precautions are necessary for colonized patients by 1) prospectively evaluating the frequency and extent of environmental contamination (surfaces, providers, equipment) caused by colonized patients and 2) using molecular epidemiological methods to evaluate the frequency of transmission events from colonized patients.

PI_NAMEs: ANDERSON, DEVERICK JOHN (contact)

PROGRAM_OFFICER_NAME: LIN, LEYI

PROJECT_TITLE: An infection prevention dilemma: should we place patients with C. difficile colonization on contact precautions?


NIH_SPENDING_CATS: Drug Abuse (NIDA only);Fentanyl Misuse and Addiction;Harm Reduction for Substance Misuse;Neurosciences;Opioid Misuse and Addiction;Opioids;Physical Injury - Accidents and Adverse Effects;Substance Misuse

ORG_CITY: PORTLAND

ORG_NAME: TORRALVA MEDICAL THERAPEUTICS, LLC

ORG_STATE: OR

PHR: PROJECT NARRATIVE: Data from the Centers for Disease Control (CDC) indicate that fentanyl and fentanyl analogues (F/FA) are the most common cause of overdose death in the U.S., underscoring the critical need for more effective overdose treatments in the ongoing opioid crisis. Torralva Medical Therapeutics, LLC has developed an animal model that replicates the unique effects of fentanyl toxicity seen in humans (vocal cord closure) and has begun target validation and development of novel formulations to effectively antagonize fentanyl doses that are routinely fatal. These formulations will solve the unmet critical need to treat naloxone-resistant effects of F/FA overdose, have the advantage they can be used for morphine- derived drug overdose (e.g. heroin) or combinations of F/FA with morphine-derived drugs, and have the potential to dominate the U.S. market for opioid overdose treatment currently estimated to be over $300 million.

PI_NAMEs: TORRALVA, PHILLIP RANDOLPH (contact)

PROGRAM_OFFICER_NAME: NGUYEN, TAM L

PROJECT_TERMS: Acute;Address;Adrenergic Receptor;Affinity;Agonist;Agreement;airway obstruction;analog;Anesthesia procedures;Animal Model;Animals;antagonist;Automobile Driving;Autopsy;Binding;Biological Models;Brain;Bypass;Centers for Disease Control and Prevention (U.S.);Cessation of life;Chest wall structure;clinical effect;Communities;community setting;Contracts;Cytoplasmic Vesicles;Data;Development;Dose;drug development;drug discovery;drug testing;effective therapy;Failure;FDA approved;Fentanyl;fentanyl analog;fentanyl overdose;Fiber Optics;Field Reports;Formulation;Generic Drugs;Goals;Helping to End Addiction Long-term;Heroin;Human;Illicit Drugs;improved;In Vitro;in vivo;in vivo evaluation;Injectable;Intervention;Intramuscular;Intravenous;Intubation;Laryngismus;Lead;Left;Lipids;Literature;Marketing;Measures;Mechanics;Medical;meetings;Modeling;Morphine;Movement;mu opioid receptors;Muscle Rigidity;Naloxone;naloxone dispensing;naloxone dosing;Neurotransmitter Receptor;noradrenergic;Norepinephrine;Nose;novel;novel therapeutics;off-target site;Opioid;Opioid Antagonist;opioid epidemic;opioid mortality;opioid overdose;Overdose;overdose death;Overdose reversal;Peer Review;Pharmaceutical Preparations;pharmacokinetics and pharmacodynamics;pharmacologic;Pharmacology;Phase;Physiological;Plasma;postsynaptic;pre-IND studies;preservation;presynaptic;Presynaptic Terminals;Publications;Publishing;receptor;Recombinants;Reflex action;Reporting;Resistance;Respiration;Respiratory Failure;response;reuptake;Role;Site;survival outcome;Symptoms;synthetic opioid;System;Testing;Therapeutic;Time;Toxic effect;Toxicology;Tracheostomy procedure;treatment strategy;United States National Institutes of Health;Validation;Ventilatory Depression;vocal cord;Wooden Chest Syndrome

PROJECT_TITLE: Fentanyl induces naloxone-resistant vocal cord closure: target validation and development of opioid overdose treatments using a peer-reviewed animal model.


ADMINISTERING_IC: ES

ED_INST_TYPE: EARTH SCIENCES/RESOURCES

IC_NAME: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

NIH_SPENDING_CATS: Behavioral and Social Science;Climate-Related Exposures and Conditions;Clinical Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Effects of Indoor Air Pollution;Lung;Mental Health;Pediatric;Prevention;Social Determinants of Health

ORG_DEPT: SOCIAL SCIENCES

PHR: PROJECT NARRATIVE This time-sensitive project aims to assess the impact of the deadliest wildland-urban interface (WUI) fires in US history on mental and respiratory health in both child and adult victims. Assessments will be made at baseline and one year later with a goal to provide data, biospecimens and environmental samples for future investigation of long-term health effects and lasting community concerns.

PI_NAMEs: GOEBERT, DEBORAH A.;ZHANG, JUNFENG  (contact)

PROGRAM_OFFICER_NAME: QUINN, ASHLINN KO

PROJECT_TERMS: Academia;Address;Adult;Affect;Agreement;Agriculture;Air;Air Conditioning;Area;Arsenic;Asbestos;Asian Americans;Automobiles;Back;Biological;Biological Markers;Biomass;Burn injury;Chemicals;Child;Clinic;Collaborations;Communication;Communities;Community Health;community organizations;community partnership;Complex;Complex Mixtures;Construction Materials;Consultations;County;COVID-19;Cultural Sensitivity;Data;Deglutition;demographics;Dioxins;Disasters;disorder risk;drinking water;Dust;Economics;Education;elementary school;Emergency Situation;Enrollment;Environment;environmental change;Environmental Exposure;epidemiology study;experience;Exposure to;Fire - disasters;Flame Retardants;follow up assessment;follow-up;Furniture;Future;Goals;Government;Guidelines;Hawaii;Health;health assessment;Health Hazards;health management;Health Services;Health Status;House Dust;Household;Human;Individual;Investigation;junior high school;Lead;Life Style;Measures;meetings;member;Mental Health;Modification;National Institute of Environmental Health Sciences;Native Hawaiian or Other Pacific Islander;operation;Outcome;Participant;Persons;Pesticide Residues;physical health service;Poison;Policies;pollutant;Protocols documentation;Psyche structure;Public Health;pulmonary function;Recording of previous events;Recovery;Reporting;Research;Research Personnel;Resources;respiratory health;Respiratory Signs and Symptoms;response;Sampling;Schools;Site;Social Work;socioeconomics;Soil;Standardization;Structure;Suicide;Surveys;Time;tool;Toxic effect;Toxicant exposure;Training;Visit;water quality;Well in self;Wildfire;wristband

PROJECT_TITLE: Mental and Respiratory Health Impacts of the Maui WUI Fire in Children and Adults

STUDY_SECTION_NAME: Special Emphasis Panel[ZES1 VSM-W (TS)]


ORG_CITY: BETHESDA

ORG_NAME: HENRY M. JACKSON FDN FOR THE ADV MIL/MED

PHR: PROJECT NARRATIVE This study addresses the mechanisms that control initiation of homologous recombination in mammals. Recombination defects, including reduced recombination efficiency and improper placement of recombination events, are invariably associated with infertility, miscarriage and aneuploidy-related birth defects. Progress in the recombination field will lead to a better understanding of the causes of faulty chromosome segregation and eventually to developing measures for their early diagnosis and prevention of resulting health conditions.

PI_NAMEs: PETUKHOVA, GALINA  (contact)

PROGRAM_OFFICER_NAME: ADKINS, RONALD

PROJECT_TERMS: Address;Alleles;Aneuploidy;Animals;Automobile Driving;Binding;Binding Sites;Birds;bisulfite sequencing;Canis familiaris;ChIP-seq;Chromatin;chromatin remodeling;Chromosomal Rearrangement;Chromosome Segregation;Chromosomes;Conflict (Psychology);Congenital Abnormality;CpG Islands;Data;Defect;Detection;Didelphidae;DNA;DNA Binding;DNA Methylation;Early Diagnosis;Electrophoretic Mobility Shift Assay;Elements;Enhancers;Event;Evolution;Failure;Fertility;Fishes;follow-up;Frequencies;functional genomics;Gametogenesis;Generations;Genes;genetic information;Genetic Recombination;Genetic Variation;Genome;genome-wide;genomic locus;Genomic Segment;Goals;Haplotypes;Health;Histone H3;homologous recombination;Human;Individual;Infertility;Inherited;Knock-out;Knockout Mice;Location;Lysine;Mammals;Maps;Marsupialia;Measures;Meiosis;Methylation;methylation pattern;Monodelphis Domestica;Mus;mutant;Nematoda;Nucleotides;Plants;Population;Positioning Attribute;pressure;Prevention;Process;promoter;Proteins;Rattus;Resolution;Role;segregation;Site;Specificity;Spontaneous abortion;Structure;Time;Yeasts

PROJECT_TITLE: Evolution of Homologous Recombination Mechanisms

STUDY_SECTION: GVE

STUDY_SECTION_NAME: Genetic Variation and Evolution Study Section[GVE]


ADMINISTERING_IC: AA

IC_NAME: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Basic Behavioral and Social Science;Behavioral and Social Science;Neurosciences;Pediatric;Substance Misuse;Underage Drinking

ORG_CITY: NEW ORLEANS

ORG_DEPT: ANATOMY/CELL BIOLOGY

ORG_NAME: LSU HEALTH SCIENCES CENTER

ORG_STATE: LA

PHR: Project Narrative Understanding of the development of anxiety/depression during alcohol withdrawal is critical to the prevention of relapse during alcohol abstinence and overall treatment of alcoholism. This project investigates the effects of adolescent alcohol use on a primary neurotransmitter system (glutamate) in key brain areas (the extended amygdala) known to be important for the development of anxiety/depression. These studies also explore differences in the development of these behaviors between sexes.

PI_NAMEs: WILLS, TIFFANY A (contact)

PROGRAM_OFFICER_NAME: CUI, CHANGHAI

PROJECT_TERMS: Acute;Adolescence;Adolescent;adolescent alcohol effect;adolescent alcohol exposure;Adult;alcohol abstinence;Alcohol consumption;alcohol exposure;alcohol relapse;alcohol testing;alcohol use disorder;Alcohol withdrawal syndrome;alcoholism therapy;Alcohols;Amygdaloid structure;antagonist;Anxiety;Area;Behavior;Behavioral;behavioral phenotyping;behavioral response;biological adaptation to stress;Brain;Brain region;Cell Nucleus;Data;designer receptors exclusively activated by designer drugs;Development;Electrophysiology (science);experience;Exposure to;Female;foot;Freezing;Future;Genetic;Glutamates;Goals;Hippocampus;Hypothalamic structure;innovation;LoxP-flanked allele;male;Male Adolescents;Mediating;Mental Depression;Modeling;Molecular;mouse model;Mus;negative affect;Neurons;Neurotransmitters;Output;paraventricular nucleus;pharmacologic;Pharmacotherapy;Phenotype;Physiological;presynaptic;prevent;receptor;Recording of previous events;Relapse;relapse prevention;restraint stress;Risk;Risk Factors;Role;sex;Sex Differences;sexual dimorphism;Shock;Signal Transduction;Stress;stressor;Structure;Structure of terminal stria nuclei of preoptic region;Synaptic Transmission;System;Testing;transmission process;underage drinking;Withdrawal;Work

PROJECT_TITLE: Sex Specific Effects of Adolescent Alcohol Exposure on BNST Plasticity

STUDY_SECTION: NAL

STUDY_SECTION_NAME: Neurotoxicology and Alcohol Study Section[NAL]


NIH_SPENDING_CATS: Autism;Basic Behavioral and Social Science;Behavioral and Social Science;Brain Disorders;Intellectual and Developmental Disabilities (IDD);Mental Health;Neurosciences;Pediatric;Prevention

ORG_CITY: BOSTON

ORG_NAME: BOSTON CHILDREN'S HOSPITAL

PHR: Project Narrative Understanding neurobiological, behavioral, and environmental factors preventing and promoting early language development in autism would facilitate development of more effective and personalized therapies to improve language and communication abilities in autistic children with significant delays. This application combines EEG data, language assessments, and natural language samples collected across four studies from 2-to-4 year old children diagnosed with autism, with the goal of identifying EEG measures associated with late talking, as well as behavioral and environmental factors that influence further language gains over the preschool years.

PI_NAMEs: WILKINSON, CAROL LEE (contact)

PROGRAM_OFFICER_NAME: STORKEL, HOLLY LYNN

PROJECT_TERMS: 2 year old;3 year old;4 year old;6 year old;Age;Autism Diagnosis;autism spectrum disorder;autism symptoms;autistic;autistic children;behavior measurement;Behavioral;Brain;Characteristics;Child;Code;Communication;Consent;Cross-Sectional Studies;Data;Data Analyses;data repository;Data Set;density;Development;Diagnosis;Early Diagnosis;Early identification;effective intervention;effective therapy;Electroencephalography;Electrophysiology (science);Enrollment;Environment;Environmental Risk Factor;Family;follow up assessment;Future;Genetic Transcription;Gestures;Goals;Growth;Heterogeneity;Hour;Impairment;improved;improved outcome;indexing;Infant;Intervention;joint attention;kindergarten;Language;Language Delays;Language Development;Language Disorders;language impairment;language outcome;Life;Measurement;Measures;Mediating;Methods;minimally verbal;multiple datasets;natural language;neural;neurobiological mechanism;Neurobiology;neuroimaging;Nursery Schools;Outcome;Output;Parent-Child Relations;Parents;Participant;Pathway interactions;Performance;personalized medicine;Predictive Factor;predictive marker;prevent;Quality of life;Research Activity;response;Rest;Sample Size;Sampling;School-Age Population;secondary analysis;Severities;Siblings;skills;social relationships;Standardization;success;targeted delivery;Therapeutic Intervention;therapy development;Time;Toddler;United States National Institutes of Health;verbal;Vocation

PROJECT_TITLE: Predictors of variable language development in autism

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 BP-R (51)]


ED_INST_TYPE: SCHOOLS OF OSTEOPATHIC MEDICINE

NIH_SPENDING_CATS: Genetics

ORG_CITY: EAST LANSING

ORG_NAME: MICHIGAN STATE UNIVERSITY

ORG_STATE: MI

PHR: Project Narrative Tissue resident macrophages (TRMs) are sentinels of the environment that maintain organ homeostasis, yet they remain refractory to standard experimental approaches limiting our understanding of their underlying regulatory mechanisms. We developed a discovery pipeline combining functional genetics with a unique ex- vivo model of lung-specific TRMs, alveolar macrophages, that will enable fundamental discoveries of the TRM functions and maintenance. My research program will leverage these tools to identify new signaling pathways, transcriptional networks and functional mechanisms required for TRMs to maintain tissue homeostasis.

PI_NAMEs: OLIVE, ANDREW  (contact)

PROGRAM_OFFICER_NAME: ZHAO, XIAOLI

PROJECT_TITLE: Genetic Mechanisms of Tissue-Resident Macrophage Maintenance and Function (Supplement)


ORG_CITY: BALTIMORE

ORG_DEPT: PHARMACOLOGY

ORG_NAME: UNIVERSITY OF MARYLAND BALTIMORE

PHR: Neurodevelopmental disorders have devastating and lasting consequences and are more likely in males and individuals experiencing inflammation early in life. Mast cells are an innate immune cell that reside in the brain and contribute to both normal development and inflammation, but how these roles are manifest is poorly understood and the goal of the proposed studies

PI_NAMEs: MCCARTHY, MARGARET M. (contact)

PROGRAM_OFFICER_NAME: TONELLI, LEONARDO HERALDO

PROJECT_TERMS: Affect;Allergic Reaction;Apraxia;Attention;autism spectrum disorder;Blood - brain barrier anatomy;blood-brain barrier permeabilization;Bone Marrow;Brain;brain cell;Cell Degranulation;Cell division;Cell Proliferation;Cells;Child Health;comparative;cranium;critical period;Cytoplasmic Granules;deep sequencing;density;dentate gyrus;Development;Developmental Delay Disorders;Diagnosis;Disease;Epigenetic Process;epigenetic regulation;Epilepsy;Event;Exhibits;experience;Female;Fluorescein-5-isothiocyanate;Funding;Gender;Gene Expression Profiling;Genetic Transcription;Goals;granule cell;Health;Hematopoietic;Heterogeneity;Hippocampus;Histamine;Hormones;Hyperactivity;Hypersensitivity;Hypothalamic structure;Immune;improved;Individual;Inflammation;Inflammation Mediators;Innate Immune System;Label;Laboratory Rat;Learning Disabilities;Life;male;mast cell;Measures;Mediating;member;Microglia;migration;Modeling;Morphology;Neurodevelopmental Disorder;neuroinflammation;Neurologic;Neurons;neutralizing antibody;novel;Outcome;pathogen;Peripheral;pharmacologic;Population;postnatal;Preoptic Areas;Prevention;Proliferating;Prostaglandins;Proto-Oncogene Protein c-kit;Reporting;Risk;Risk Factors;Role;Schizophrenia;sex;Sex Differences;Sex Differentiation;Short-Term Memory;Source;Speech;Stem Cell Factor;Stimulus;Synapses;Testing;Therapeutic Intervention;Tissues;transcriptome;Yolk Sac

PROJECT_TITLE: Neuroinflammation, Epigenetics and Male Vulnerability

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1(02)-M]


ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

NIH_SPENDING_CATS: Neurosciences

ORG_CITY: Aurora

ORG_DEPT: BIOLOGY

ORG_NAME: UNIVERSITY OF COLORADO DENVER

ORG_STATE: CO

PHR: This Project Narrative was originally submitted with R25 NS130620 and is included here unchanged to satisfy submission system requirements. PROJECT NARRATIVE The Neuroscience Colorado Research Experience (N-CORE) is an innovative summer research experience for undergraduate students from underrepresented backgrounds in the Denver Metropolitan and Regional area. N- CORE has forged a strong alliance with the Neuroscience Graduate Program at the University of Colorado Anschutz Medical Campus and will fulfill the goal of PAR-21-168 through a rigorous recruitment plan, an authentic research experience, a comprehensive education plan, and longitudinal mentoring. N-CORE fosters a community for like-minded students from similar backgrounds—a key component for retention of URM students in biomedical fields.

PI_NAMEs: RESTREPO, DIEGO ;SALCEDO, ERNESTO  (contact)

PROGRAM_OFFICER_NAME: MATTHEWS, MARGUERITE

PROJECT_TERMS: Area;Biomedical Research;career;Career Choice;Clinical Research;Colorado;Communication;Communities;Development;doctoral student;Education;education planning;Enrollment;Ensure;Environment;experience;faculty mentor;forging;Fostering;Goals;Individual;innovation;Institution;Instruction;interest;Internships;Leadership;Medical;medical schools;Mentors;Mentorship;metropolitan;Mind;Neurosciences;Neurosciences Research;operation;pre-doctoral;programs;recruit;Reproducibility;Research;Research Training;Students;success;summer internship;summer program;summer research;symposium;System;Training;Training Programs;undergraduate research;undergraduate research experience;undergraduate student;Underrepresented Students;United States National Institutes of Health;Universities

PROJECT_TITLE: The Neuroscience Colorado Research Experience (N-CORE) - building a sustainable summer training research experience for undergraduate students from diverse backgrounds


NIH_SPENDING_CATS: Aging;Bioengineering;Biotechnology;Cancer;Colorectal Cancer;Digestive Diseases;Genetics;Immunization;Infectious Diseases;Nanotechnology;Orphan Drug;Prevention;Rare Diseases;Vaccine Related

ORG_CITY: PHILADELPHIA

ORG_NAME: RESEARCH INST OF FOX CHASE CAN CTR

ORG_STATE: PA

PI_NAMEs: CLAPPER, MARGIE  (contact)

PROJECT_TERMS: Acceleration;adenoma;Adult;Adverse effects;African American;Age;aged;American;Animals;Antibiotics;Antigens;APC gene;ApcMin/+ mice;Bacillus;Bacteria;Bacteroides fragilis;base;Binding;Biological;biomaterial compatibility;Cancer Etiology;cancer risk;Cell Physiology;Cell-Mediated Cytolysis;Chemopreventive Agent;Child;cigarette smoking;Clinical;Codon Nucleotides;Colitis;Colon;Colonoscopy;Colorectal;Colorectal Adenoma;Colorectal Cancer;colorectal cancer risk;colorectal cancer screening;Colorectal Neoplasms;Colorectal Polyp;Containment;COVID-19;COVID-19 vaccine;Cytoprotection;Data;Dental Plaque;design;Development;Diagnosis;Disease;Distant;Distant Metastasis;DNA;draining lymph node;Dysplasia;Early Diagnosis;effector T cell;efficacy testing;Encapsulated;Enhancers;Epitopes;Familial Adenomatous Polyposis Syndrome;Family history of;Feces;Fortification;Fusobacteria;Fusobacterium;Fusobacterium nucleatum;gene repair;Genetic;Germ-Line Mutation;glycerophosphodiester phosphodiesterase;Goals;Gram-Negative Bacteria;Helicobacter pylori;Hepatitis B Virus;Hereditary Nonpolyposis Colorectal Neoplasms;Human;Human Papilloma Virus Vaccine;Immune;Immune Sera;Immunity;immunogenic;immunogenicity;Immunoglobulins;Immunosuppression;improved;in vivo;Incidence;Individual;Infection;Infection prevention;infection rate;Infectious Agent;Inflammatory Bowel Diseases;Inherited;Innate Immune Response;Intervention;ITIM;Lesion;lipid nanoparticle;Malignant Breast Neoplasm;Malignant neoplasm of cervix uteri;Malignant neoplasm of gastrointestinal tract;Malignant Neoplasms;malignant stomach neoplasm;Measures;Mediating;Membrane;Messenger RNA;Methodology;microbiota;Microsatellite Instability;Mismatch Repair;Mismatch Repair Deficiency;Modeling;Modification;Morbidity - disease rate;mortality;mouse model;mutation carrier;Natural Killer Cells;Neoplasm Metastasis;neoplastic cell;Non-Insulin-Dependent Diabetes Mellitus;Nonsense Mutation;Obesity;Oncogenic;Operative Surgical Procedures;Oral;Organ;pathogen;Patients;Phase;Population;Preclinical Drug Development;preclinical efficacy;premalignant;Prevalence;prevent;Prevention strategy;Preventive;Preventive measure;Preventive vaccine;Primary carcinoma of the liver cells;Program Development;prophylactic;Proteins;Proteomics;Pseudouridine;Race;receptor;Recommendation;Recording of previous events;Regimen;Regulatory T-Lymphocyte;Reporter;Resistance;Risk;Risk Factors;RNA;RNA vaccine;Role;scale up;screening;Small Intestinal Neoplasm;Survival Rate;Syndrome;System;T-Lymphocyte;Time;Tissues;tumor;Tumor Escape;tumor growth;tumor microenvironment;Tumor Promotion;tumorigenesis;tumorigenic;United States;United States Preventative Services Task Force;Update;Vaccination;Vaccine Antigen;vaccine platform;Vaccines;vaccinology;Vesicle;Virulence Factors;Wild Type Mouse

PROJECT_TITLE: BASE TITLE: PREVENT PRECLINICAL DRUG DEVELOPMENT PROGRAM:  PRECLINICAL EFFICACY AND INTERMEDIATE ENDPOINT BIOMAKERSTASK ORDER TITLE: VACCINES AGAINST FUSOBACTERIUM FOR FAP-AND LYNCH SYNDROME-ASSOCIA


NIH_SPENDING_CATS: Diabetes;Genetics;Kidney Disease

ORG_NAME: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI

ORG_STATE: NY

PHR: Project narrative More than 400 million people suffer from diabetes in the world and one third of them may eventually develop diabetic kidney disease (DKD). DKD patients frequently develop cardiovascular disease. This study will explore the mechanism by which KLF2 protein, previously shown to provide cardiovascular protection, can also confer kidney protection in diabetic settings.

PI_NAMEs: DAS, BHASKAR CHANDRA;HE, JOHN CIJIANG (contact);LEE, KYUNG ;ZHONG, FANG

PROGRAM_OFFICER_NAME: NIHALANI, DEEPAK

PROJECT_TERMS: Address;Affect;Agonist;angiogenesis;Animal Model;antagonist;Anti-Inflammatory Agents;antiangiogenesis therapy;Antiinflammatory Effect;Attenuated;Biological Assay;Biological Process;Blood Vessels;Cardiovascular Diseases;Cardiovascular system;cell injury;Cell Physiology;ChIP-seq;comorbidity;cytokine;Data;Development;Diabetes Mellitus;diabetic;Diabetic mouse;Diabetic Nephropathy;diabetic patient;Disease;Disease Progression;DNA Binding;Drug Targeting;Endothelial Cells;Estrogens;Event;Female;Functional disorder;gene function;Genes;Genetic Transcription;glomerular endothelium;Glucose;Glucose Transporter;Gonadal Steroid Hormones;hemodynamics;Heterozygote;Human;improved;In Vitro;in vivo;Inflammatory;inhibitor;Injury;Injury to Kidney;Interleukin-1 beta;Kidney;Kidney Diseases;kidney dysfunction;Knockout Mice;lead optimization;Luciferases;male;Mediating;Mineralocorticoid Receptor;Missense Mutation;Mus;Mutation;Nephrectomy;NF-kappa B;novel;novel drug class;novel therapeutics;overexpression;Oxidative Stress;Pathologic;Pathway interactions;Patients;Persons;Pharmacotherapy;Phenotype;process optimization;Protective Agents;protective effect;protective factors;Proteins;Proteinuria;Regulation;Reporter;Role;screening;Series;shear stress;single-cell RNA sequencing;Sodium;targeted treatment;Testing;thrombotic;TNF gene;transcriptome;Transforming Growth Factor alpha

PROJECT_TITLE: KLF2 is a novel endoprotective target for DKD

STUDY_SECTION: PBKD

STUDY_SECTION_NAME: Pathobiology of Kidney Disease Study Section[PBKD]


NIH_SPENDING_CATS: Behavioral and Social Science;Childhood Obesity;Clinical Research;Clinical Trials and Supportive Activities;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Nutrition;Obesity;Pediatric;Prevention;Racial and Ethnic Minority Health Research;Social Determinants of Health

ORG_NAME: TEMPLE UNIV OF THE COMMONWEALTH

PHR: PROJECT NARRATIVE Racial and ethnic minority adolescents in low-resource communities (i.e., high-risk) have the highest intake of added sugar (AS) and are disproportionately at-risk for diet-related chronic disease in adulthood, highlighting that AS is a critically important and potentially impactful target for intervention efforts. This K01 study aims to provide an in-depth understanding of the key drivers of AS intake in high-risk adolescents using ecological momentary assessment, develop a contextually tailored, technology-enriched intervention to reduce AS intake, and assess outcomes using a novel objective biomarker of AS intake. This study will leverage state-of-the- art methodologies to provide high-quality evidence on AS intake in high-risk adolescents and has the potential to reduce diet-related chronic risk during the transition to adulthood.

PI_NAMEs: TRIPICCHIO, GINA L. (contact)

PROGRAM_OFFICER_NAME: DONZE, LAURIE FRIEDMAN

PROJECT_TERMS: 16 year old;acceptability and feasibility;Address;Administrative Supplement;Adolescent;Adult;age group;Award;Behavior Therapy;Behavioral trial;Biological Markers;Calories;Carbon;Childhood;Chronic;Chronic Disease;Communities;comparison group;Consumption;design;Development;Diet;dietary;Dietary intake;Dietary Intervention;digital intervention;disorder risk;Disparity;Doctor of Philosophy;Eating Behavior;Ecological momentary assessment;Education;Ensure;ethnic minority;Event;experience;Goals;high risk;high risk population;high-risk adolescents;improved;innovation;Intake;Intervention;Life;live text;Low income;Measures;Mentored Research Scientist Development Award;Mentors;Mentorship;Methodology;minority children;novel;nutrition;Nutritional;Obesity;Outcome;Outcome Assessment;Parents;Participant;Patient Self-Report;Philadelphia;Population;Population Heterogeneity;primary outcome;programs;Public Health;racial minority;Reducing diet;Research;Resource-limited setting;Resources;Risk;Sampling;secondary outcome;stable isotope;Statistical Models;statistics;sugar;Technology;Testing;Time;Training;transition to adulthood;Universities;vulnerable adolescent;Work;Youth

PROJECT_TITLE: Administrative Supplement:  Targeting added sugar to improve dietary intake in high-risk adolescents

STUDY_SECTION: MCBS

STUDY_SECTION_NAME: NHLBI Mentored Clinical and Basic Science Study Section[MCBS(JA)]


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Biotechnology;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Gene Therapy;Gene Therapy Clinical Trials;Genetics;Immunotherapy;Orphan Drug;Rare Diseases

ORG_CITY: HOUSTON

ORG_NAME: METHODIST HOSPITAL RESEARCH INSTITUTE

ORG_STATE: TX

PHR: Project Narrative T cells engineered to target tumors have shown a great promise in treating cancer. We propose to open a phase I clinical trial to examine the safety and tolerability of CAR T cells against advanced thyroid cancer with no alternative treatment options, and to perform more basic studies to improve future adoptive cell therapy. Our effort can lead to a safe yet new therapy for refractory thyroid and other type of cancers.

PI_NAMEs: JIN, MOONSOO M. (contact)

PROGRAM_OFFICER_NAME: HENDERSON, LORI A

PROJECT_TERMS: Adjuvant Therapy;Adopted;Adoptive Cell Transfers;alternative treatment;anaplastic thyroid cancer;Applications Grants;Automobile Driving;Biological;Biological Markers;Blood;Cancer cell line;cancer type;CAR T cell therapy;Categories;CD19 gene;cell type;Cells;cellular imaging;Characteristics;chimeric antigen receptor;chimeric antigen receptor T cells;Clinical;clinical care;clinical predictors;Clinical Research;Clonal Expansion;Clonality;cost;cytokine;Cytolysis;design;Disease;Distant Metastasis;Dose;efficacy evaluation;engineered T cells;Engineering;Evaluation;exhaustion;FDA approved;fitness;Future;Gene Expression;Gene Expression Profile;genetic signature;Goals;Human;I131 isotope;improved;in vivo;Incidence;Industry Collaboration;Infusion procedures;Institutional Review Boards;Intercellular adhesion molecule 1;Investigational New Drug Application;Kinetics;Label;Letters;liquid biopsy;Malignant neoplasm of thyroid;Malignant Neoplasms;manufacture;Measures;metabolic profile;Molecular Profiling;mouse model;National Cancer Institute;next generation;Normal Cell;novel therapeutics;Operative Surgical Procedures;Outcome;overexpression;Papillary;participant enrollment;patient derived xenograft model;patient population;Patients;Pattern;PD-1 blockade;peripheral blood;PET/CT scan;Phase;phase 1 study;phase 2 study;Phase I Clinical Trials;preclinical study;Prognosis;Proliferating;Radioactive Iodine;Radiolabeled;Recommendation;Refractory;Relapse;Resistance;response;Safety;safety assessment;single cell analysis;Site;Solid;Solid Neoplasm;somatostatin receptor 2;spatiotemporal;standard care;T cell clonality;T-Lymphocyte;targeted treatment;Technology;Testing;Therapeutic;Thyroid Gland;time use;Tissues;Toxic effect;Tracer;Treatment Protocols;tumor;tumor DNA;Undifferentiated;virtual;X-Ray Computed Tomography;Xenograft Model

PROJECT_TITLE: CAR T Cells for Advanced Thyroid Cancer

STUDY_SECTION: CONC

STUDY_SECTION_NAME: Clinical Oncology Study Section[CONC]