NIH_SPENDING_CATS: Cancer;Cancer Genomics;Clinical Research;Clinical Trials and Supportive Activities;Colorectal Cancer;Dental, Oral, and Craniofacial Disease;Digestive Diseases;Genetics;Human Genome;Lung;Lung Cancer;Nutrition;Obesity;Prevention;Radiation Oncology

ORG_CITY: DUARTE

ORG_NAME: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE

PHR: Project Narrative Cancer is the second most common cause of death in developed nations with an estimated 70% of cases attributable to “modifiable” risk factors associated with oxidative stress (e.g., obesity, poor diet, and chronic inflammation). Here, we propose to examine whether these modifiable risk factors are associated with and modulate the accumulation of reactive oxygen species (ROS)-mediated DNA damage. To do this, we will: 1) Determine the relationship between ROS-induced mutations, inflammation-related cancer risk factors, and clinical outcomes in a large cohort of colorectal cancer patients with longitudinal lifestyle data; 2) Explore the molecular mechanism(s) through which lifestyle risk factors may modulate the accumulation of and functional impact of ROS mediated DNA damage on cancer development; and 3) Assess the molecular impact and/or potential clinical benefit of using intermittent fasting during radiotherapy to reduce radiation-induced ROS mutations in normal tissues and mitigate treatment toxicity.

PI_NAMEs: LI, YUN ROSE (contact)

PROGRAM_OFFICER_NAME: MILLER, BECKY

PROJECT_TERMS: Acute;Adverse event;Aging;Algorithms;Animal Model;Animals;Appointment;Architecture;Binding;Binding Sites;Biological;Biological Assay;Biological Markers;Caloric Restriction;Cancer Biology;cancer cell;cancer genome;cancer initiation;Cancer Patient;cancer risk;Carcinogen exposure;carcinogenesis;Carcinogens;career;career networking;Cause of Death;CCCTC-binding factor;Cell Cycle Regulation;Cell Line;Cells;ChIP-seq;Chromatin;Chronic;chronic inflammatory disease;Cities;Clinical;Clinical Data;clinical translation;Clonal Expansion;cohort;colon cancer patients;Colorectal;Colorectal Cancer;Colorectal Neoplasms;Computational Biology;Computational Technique;computerized tools;cytokine;Data;Dedications;Defect;Developed Countries;Developing Countries;Development;Diet;dietary;Disease;DNA Damage;DNA Repair;DNA Sequence Alteration;driver mutation;Energy Intake;Epidemiology;Epigenetic Process;epigenomics;Exercise;experience;Exposure to;Extramural Activities;Faculty;Fasting;Feces;Funding;Future;Genes;Genetic;genome sequencing;Genomics;Growth;High School Student;Human;improved;Incidence;Individual;Induced Mutation;induced pluripotent stem cell;Induction of Apoptosis;Inflammation;Inflammatory;Institution;Intake;Intermittent fasting;International;Joints;Journals;Laboratories;Lead;Leadership;Life Style;lifestyle data;lifestyle factors;Link;Location;Malignant neoplasm of gastrointestinal tract;Malignant neoplasm of prostate;Malignant Neoplasms;Mathematics;Meat;Mediating;Medicine;Mentors;Mentorship;Metabolic;modifiable risk;Molecular;Molecular Biology;Molecular Computations;Molecular Epidemiology;multidisciplinary;multiple omics;Mutagenesis;Mutagens;Mutation;Normal Cell;Normal tissue morphology;novel;Obesity;obesity genetics;Outcome;Oxidative Stress;Patients;Pattern;Peer Review;Pelvis;Peripheral Blood Mononuclear Cell;Personal Satisfaction;phase 3 study;Phase I/II Trial;Physicians;Positioning Attribute;Postdoctoral Fellow;pre-clinical;Predisposition;primary endpoint;Probability;Process;professor;promoter;prospective;Publications;Quality of life;Radiation;Radiation Oncology;Radiation therapy;Randomized;Reactive Oxygen Species;Rectal Cancer;repaired;Reporting;Research;Risk Factors;Safety;Science;Scientist;side effect;Smoking;Societies;Somatic Mutation;Testing;Therapeutic;Therapeutic Index;Time;Tissues;tool;Toxic effect;TP53 gene;transcriptome sequencing;Translating;Treatment-related toxicity;tumor;tumorigenesis;Ultraviolet Rays;Unhealthy Diet;Urine;Urothelial Cell;whole genome;Work

PROJECT_TITLE: Biomarkers, mechanisms and modulation of oxidative stress associated risk factors in carcinogenesis


ADMINISTERING_IC: CA

ARRA_FUNDED: N

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Aging;Bioengineering;Genetics;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD)

ORG_CITY: ROCHESTER

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: MAYO CLINIC ROCHESTER

ORG_STATE: MN

PHR: PROJECT NARRATIVE This project will contribute to fundamental knowledge about the nature and distribution of senescent cells in human tissues during the aging process. Specifically, it will generate cutting- edge technology that will allow the reliable mapping of senescent cells across multiple tissues. This technology will not only assist the generation of a human atlas of senescence but also have great potential in clinical practice as a prognostic tool, as a measure of biological age as well as efficacy of treatments.

PI_NAMEs: PASSOS, JOAO  (contact)

PROGRAM_OFFICER_NAME: JHAPPAN, CHAMELLI

PROJECT_TERMS: 3-Dimensional;Age;age-related disease;Aging;aging process;aging related;Atlases;Autophagocytosis;biological age;Biological Response Modifier Therapy;Biopsy;Cell Aging;Cell Communication;Cell Nucleus;Cells;Chronic;clinical practice;Collaborations;Communities;Computer software;Computing Methodologies;Cytometry;Data;Dedications;deep learning;Detection;Development;DNA Damage;drivers of aging;Emerging Technologies;Exclusion;Extracellular Space;Fluorescence Microscopy;Functional disorder;Generations;hallmarks of aging;Hour;Human;human tissue;Image;imaging modality;Impairment;Inflammation;innovation;innovative technologies;insight;Intervention;Knowledge;Laboratories;learning network;Length;Machine Learning;Maps;Measurement;Measures;Mediating;Methods;microscopic imaging;mitochondrial dysfunction;Morphologic artifacts;multiplexed imaging;Mus;Nature;neural network;next generation;Obesity;Play;pro-aging;Process;prognostic tool;Proteins;Reproducibility;Research;Resources;response;Role;senescence;senescence associated secretory phenotype;senescent cell;Signal Transduction;Signaling Protein;single cell technology;Spatial Distribution;Stains;Suspensions;Technology;technology validation;telomere;telomere damage;Time;tissue mapping;tissue resource;Tissues;Treatment Efficacy

PROJECT_TITLE: Development of machine learning software to quantitatively map telomere induced senescence in tissue sections during aging

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-CB-T(70)R]


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Childhood Obesity;Clinical Research;Contraception/Reproduction;Diabetes;Maternal Health;Maternal Morbidity and Mortality;Nutrition;Obesity;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Pregnancy;Prevention;Women's Health Research

ORG_CITY: PROVIDENCE

ORG_NAME: WOMEN AND INFANTS HOSPITAL-RHODE ISLAND

ORG_STATE: RI

PHR: The United States spends approximately 300 million dollars annually to screen four million pregnant women for gestational diabetes mellitus (GDM). However, as currently performed, GDM screening, diagnosis, and treatment is not cost-effective because it does not adequately mitigate risks, including the risk of childhood obesity associated with GDM. The proposed multi-center prospective cohort study will allow for the redesign of GDM care by assessing maternal glycemia at multiple points in pregnancy and post-partum to determine the types and timing of dysglycemia most associated with GDM-related complications, including childhood obesity.

PI_NAMEs: WERNER, ERIKA F (contact)

PROGRAM_OFFICER_NAME: BROADNEY, MIRANDA MARGUERITE

PROJECT_TERMS: 2 year old;Address;Admission activity;adult obesity;American College of Obstetricians and Gynecologists;biobank;Birth trauma;Body mass index;Caring;Cesarean section;Child;Childhood;Clinic;Clinical Research;clinically significant;Cohort Studies;Consensus;Continuous Glucose Monitor;cost;Cost Analysis;cost effective;Data;Decision Modeling;design;Diabetes Mellitus;Diagnosis;early childhood;Enrollment;Ensure;ethnic diversity;Fasting;Female;First Pregnancy Trimester;follow-up;Functional disorder;Future Generations;Gestational Age;Gestational Diabetes;Glucose;Glucose tolerance test;Glycosylated Hemoglobin;Growth;Health;Healthcare;high risk;Hospitals;Hyperbilirubinemia;improved;Infant;Intensive Care Units;Knowledge;Life;Maternal and Child Health;maternal serum;Measurement;Measures;Metabolic;Modality;monitoring device;Morbidity - disease rate;Neonatal;Neonatal Hypoglycemia;neonate;next generation;Obesity;obesity in children;offspring;Outcome;Pathologic;Physiological;Placenta;Population;population health;Postpartum Period;Pre-Eclampsia;Pregnancy;Pregnancy Complications;Pregnancy in Diabetics;pregnant;Pregnant Women;premature;Premature Birth;Prenatal care;Professional Organizations;Prospective cohort;Prospective, cohort study;Research Infrastructure;Risk;Risk Factors;risk mitigation;Risk Reduction;Savings;screening;screening guidelines;Second Pregnancy Trimester;societal costs;Societies;success;Techniques;Testing;Third Pregnancy Trimester;Time;tool;United States;United States National Institutes of Health;Universities;Variant;Woman

PROJECT_TITLE: Comparing Glycemic Profiles in Pregnancy and Maternal and Child Health Outcomes


ADMINISTERING_IC: HD

ED_INST_TYPE: SCHOOLS OF MEDICINE

IC_NAME: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT

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

ORG_CITY: CHAPEL HILL

ORG_DEPT: PSYCHIATRY

ORG_NAME: UNIV OF NORTH CAROLINA CHAPEL HILL

ORG_STATE: NC

PHR: Project Narrative This ACE Network proposal, entitled “A Longitudinal Brain and Behavior Study of Autism from Infancy through Adolescence”, aims to examine 400 children (300 infants at high familial risk and 100 infants at low familial risk for autism spectrum disorder (ASD)), who have been previously examined at multiple time points from infancy through school-age, using detailed brain imaging and behavior assessments, and who are now proposed for re- assessment in adolescence. The main goals of this proposal are to characterize brain and brain-behavior relationships in ASD, from infancy through adolescence; identify infant-to-school-age brain and behavior features that predict clinically-relevant outcomes in adolescence that are associated with familial risk for ASD; and to employ a novel approach to define the expression of familial ASD risk in adolescent females that will have more relevance for biological studies than current definitions, identify early childhood markers of clinical impairment associated with ASD risk, in adolescent females (who are often not detected earlier in childhood); and, characterize infant-to-adolescent brain development in ASD females. This study will facilitate the development of early childhood approaches to identifying poor outcomes in adolescents at risk for ASD and provide insight into the timing and nature of early interventions for ASD and related conditions.

PI_NAMEs: PIVEN, JOSEPH  (contact)

PROGRAM_OFFICER_NAME: KAU, ALICE S

PROJECT_TERMS: 11 year old;16 year old;absorption;Acceleration;Address;Adolescence;Adolescent;adolescent brain development;Adult;Age;Age Months;aging brain;Amygdaloid structure;Anxiety;Anxiety Disorders;Area;autism spectrum disorder;autism symptoms;Behavior;Behavior assessment;Behavior Disorders;behavior prediction;Behavioral;behavioral study;Biological;Biology;Brain;brain behavior;Brain imaging;Categories;Characteristics;Child;Childhood;Clinical;clinical predictors;clinically actionable;clinically relevant;clinically significant;Complex;Data;Data Reporting;design;Detection;Development;Diagnosis;Diagnostic;Dimensions;disorder risk;early childhood;Early Diagnosis;Early identification;Early Intervention;emerging adult;Familial disease;family genetics;Family Study;Female;Female Adolescents;follow-up;Functional disorder;Funding;General Population;Genetic;Goals;Growth;imaging study;Impairment;improved;inclusion criteria;Individual;individuals with autism spectrum disorder;infancy;Infant;insight;interest;Intervention;Investments;Knowledge;Life;Link;longitudinal, prospective study;male;Maps;Mental disorders;Nature;novel strategies;Outcome;outcome prediction;Pattern;Phenotype;Predictive Value;proband;prospective;Prospective cohort;psychiatric symptom;psychologic;Reporting;Research Design;Resources;Risk;Risk Marker;Sampling;School-Age Population;Siblings;skills;Social Development;Specific qualifier value;Subgroup;success;symptom cluster;Time;United States National Institutes of Health;Work

PROJECT_TITLE: A Longitudinal Brain and Behavior Study of Autism From Infancy Through Adolescence


NIH_SPENDING_CATS: Behavioral and Social Science;Cancer;Clinical Research;Clinical Trials and Supportive Activities;HIV/AIDS;Immunization;Infectious Diseases;Orphan Drug;Prevention;Rare Diseases;Vaccine Related;Vaccine Related - AIDS

ORG_CITY: NEW YORK

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI

ORG_STATE: NY

PHR: RELEVANCE TO PUBLIC HEALTH Cancer has been recognized as occurring more commonly in people living with human immunodeficiency virus infection (PLWH), and remains a leading cause of morbidity and mortality despite improvements in antiretroviral therapy. The spectrum of these cancers in PLWH is diverse, complex, and challenging to prevent and treat. AMC remains the only organization worldwide solely dedicated to the study, treatment and prevention of cancer in PLWH.

PI_NAMEs: SPARANO, JOSEPH A. (contact)

PROGRAM_OFFICER_NAME: LIDDELL HUPPI, REBECCA

PROJECT_TERMS: Accountability;Address;Africa;Africa South of the Sahara;AIDS clinical trial group;AIDS Malignancy Consortium;AIDS related cancer;antiretroviral therapy;Anus;Area;burden of illness;Cancer Biology;Cancer Control;cancer prevention;Cancer Survivor;career;Caring;Clinical;Clinical Trials;Clinical Trials Cooperative Group;Clinical Trials Network;Collaborations;Communities;community advisory board;Community Outreach;Complex;Dedications;design;Development;Diagnosis;Epidemic;Fostering;Funding;Generations;Goals;Health Professional;HIV;HIV/AIDS;Human Papilloma Virus-Related Malignant Neoplasm;improved;Incidence;insight;International;Intervention;Kaposi Sarcoma;Laboratories;Laboratory Research;Laboratory Scientists;Laboratory Study;Latin America;Leadership;Lesion;low and middle-income countries;Lymphoma;Malignant - descriptor;Malignant neoplasm of anus;Malignant Neoplasms;Mission;Morbidity - disease rate;mortality;National Cancer Institute;next generation;novel diagnostics;novel therapeutics;operation;Patients;personalized immunotherapy;Persons;Phase;phase III trial;Physicians;Population;Practice Guidelines;Precancerous Conditions;Precision therapeutics;premalignant;prevent;Prevention;Prevention approach;preventive intervention;programs;Public Health;Publications;Qualifying;Randomized;recruit;Reporting;Research;research clinical testing;Research Personnel;Role;routine screening;Scientist;screening;Site;Squamous intraepithelial lesion;standard of care;Strategic Planning;Structure;Supervision;Surveys;survivorship;translational scientist;United States;Virus Diseases;Vision;Work

PROJECT_TITLE: AIDS Malignancy Consortium (AMC)


NIH_SPENDING_CATS: Clinical Research;Emergency Care;Health Services;Hematology;Infectious Diseases;Pediatric;Sepsis

ORG_CITY: ANN ARBOR

ORG_DEPT: EMERGENCY MEDICINE

ORG_NAME: UNIVERSITY OF MICHIGAN AT ANN ARBOR

ORG_STATE: MI

PHR: PROJECT NARRATIVE: Annually, sepsis (disseminated infection) accounts for ~100,000 emergency department visits for children in the U.S. and ~ 25-50% will die or suffer long term complications if not diagnosed and treated in a timely manner. Currently, we do not understand how the child responds to infection and we cannot predict who is going to survive or respond to treatment. We propose to study sepsis in children in a comprehensive manner using state-of-the-art tools to screen diagnose, appropriately treat and predict sepsis outcomes in children who present to the ED.

PI_NAMEs: MAHAJAN, PRASHANT  (contact);RAMILO, OCTAVIO

PROGRAM_OFFICER_NAME: DIXON, CINNAMON ANNE

PROJECT_TERMS: 18 year old;Accident and Emergency department;accurate diagnosis;Address;Age;Antibiotics;Antimicrobial Resistance;Area;Bacteria;Bioinformatics;Biological Markers;Blood;Blood specimen;Categories;Cessation of life;Child;Childhood;Clinical;Clinical Data;clinical decision-making;Consent;Custom;Data;Data Set;detection assay;Diagnosis;Diagnostic;Disease;Electronic Health Record;Emergency Department patient;Emergency department visit;Enrollment;Etiology;evidence base;Exclusion;experience;Functional disorder;Future;Goals;Guidelines;Heart Rate;Hour;Immune;Immune response;Immunoassay;Immunologics;improved;Infection;Inpatients;Intervention;Knowledge;Laboratories;Life;Liquid substance;Measures;Medical;Methods;Modeling;Molecular;Morbidity - disease rate;mortality;Multicenter Studies;multidisciplinary;nanorod;nucleic acid detection;Nucleic Acids;Observational Study;Organ;Organ failure;Outcome;outcome prediction;pathogen;Patient Monitoring;patient response;Patient-Focused Outcomes;Patients;pediatric emergency;Pediatric Hospitals;pediatric patients;pediatric sepsis;Physiological;precision medicine;Process;prognostication;prospective;Provider;rapid diagnosis;Recommendation;Research Personnel;Resources;Resuscitation;Ribosomes;Risk;risk stratification;Sampling;Science;Sepsis;septic patients;Septic Shock;Shock;Speed;Subgroup;Syndrome;Technology;Temperature;tertiary care;Testing;Time;tissue culture;tool;transcriptomics;Viral;Virus;Work;working group

PROJECT_TITLE: Resubmission: Elucidating Pediatric Sepsis by Defining Comprehensive Signatures for Diagnosis and Outcome

STUDY_SECTION: ICSC

STUDY_SECTION_NAME: Interdisciplinary Clinical Care in Specialty Care Settings Study Section[ICSC]


ADMINISTERING_IC: OD

IC_NAME: OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH

NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Brain Disorders;Dementia;Dental, Oral, and Craniofacial Disease;Genetics;Human Genome;Neurodegenerative;Neurosciences;Women's Health Research

ORG_CITY: OKLAHOMA CITY

ORG_NAME: OKLAHOMA MEDICAL RESEARCH FOUNDATION

ORG_STATE: OK

PHR: PROJECT NARRATIVE After decades of failed clinical trials for the treatment of Alzheimer’s disease (AD), there is an urgent need for creative approaches to uncover new potential therapeutic targets. Examining AD through the lens of biological sex differences can shed light on pathways that confer protection or risk to AD progression. The focus of this study is the contributions of sex chromosomes to the diversity of the immune response in the hippocampus with aging and AD.

PI_NAMEs: OCANAS, SARAH RENEE (contact)

PROJECT_TERMS: 3xTg-AD mouse;AD transgenic mice;Address;Age;Aging;aging brain;aging related;Agreement;Alzheimer's Disease;Alzheimer's disease pathology;Alzheimer's disease risk;American;APP-PS1;Area;Automobile Driving;Award;biological sex;biological systems;Border Community;Brain;Calculi;career;Cell surface;cell type;Cessation of life;Clinical Treatment;Clinical Trials;Cognition;computing resources;Creativeness;Data;data integration;debilitating symptom;Dementia;Development;Diagnosis;Disease;Disease Progression;Doctor of Philosophy;Educational process of instructing;Environment;epigenome;epigenome editing;epigenomics;Excision;experience;experimental study;Faculty Recruitment;Female;Foundations;Four Core Genotypes;Funding;Genes;Genetic Transcription;genome wide association study;genome-wide;Genomics;genotypic sex;glial activation;Gliosis;Goals;Gonadal Hormones;Gonadal Steroid Hormones;graduate student;Grant;Heterogeneity;Hippocampus;Hispanic;histone modification;Histones;Hormonal;Hormone replacement therapy;Human;human disease;Immune response;immunological diversity;Impaired cognition;Inflammatory;innovation;Institution;Intervention;Knowledge;Leadership;lens;Lysine;Macrophage;male;Manuscripts;Mathematics;Medical Research;meetings;men;Mentors;Microglia;Molecular;Morphology;mouse model;Multiomic Data;Mus;National Research Service Awards;Neurofibrillary Tangles;neuropathology;Neurosciences;new therapeutic target;novel;Oklahoma;Outcome;Ovary;Paper;Pathologic;Pathology;Pathway interactions;Perimenopause;Phagocytes;Phenotype;phenotypic data;Phenotypic Sex;Ploidies;Positioning Attribute;Prevalence;Principal Investigator;Process;programs;protective factors;Regulation;Research;Research Personnel;Resolution;response;Risk;risk variant;Role;Science;sex;Sex Bias;Sex Chromosomes;Sex Differences;small molecule;South Texas;Stimulus;symposium;Techniques;Testing;Testis;Therapeutic Intervention;therapeutic target;Time;transcriptomics;United States National Institutes of Health;Woman;Work;X Chromosome

PROJECT_TITLE: Sex chromosomal regulation of hippocampal microglial activation with Alzheimer's disease and aging

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-PSE-H(70)R]


ED_INST_TYPE: SCHOOLS OF PUBLIC HEALTH

NIH_SPENDING_CATS: Clinical Research;Contraception/Reproduction;Dental, Oral, and Craniofacial Disease;Infertility;Maternal Health;Maternal Morbidity and Mortality;Pregnancy;Prevention;Social Determinants of Health;Women's Health Research

ORG_CITY: BOSTON

ORG_DEPT: PUBLIC HEALTH & PREV MEDICINE

ORG_NAME: BOSTON UNIVERSITY MEDICAL CAMPUS

ORG_STATE: MA

PHR: PROJECT NARRATIVE Activities related to the oil and gas industry release environmental contaminants, including reproductive toxicants, that may adversely affect fertility, pregnancy, and birth. Using multiple exposure measurement techniques (spatial data integration, risk perceptions, and primary exposure data collection), the proposed research will examine the influence of oil and gas development on reproductive health.

PI_NAMEs: WILLIS, MARY D (contact)

PROJECT_TERMS: Address;Affect;Air;American;Aromatic Polycyclic Hydrocarbons;Award;Back;Benzene;Birth;Boston;Canada;career;Chemicals;Child;Child Development;Child Health;cohort;Cohort Studies;Communities;community intervention;Complex;Conceptions;Contracts;cost effective;Couples;Data;Data Analyses;Data Collection;data integration;Data Science;design;Development;Diet;Disease;early pregnancy;early pregnancy loss;Enrollment;Environmental Epidemiology;Environmental Hazards;Environmental Pollutants;Epidemiology;epidemiology study;Exposure to;Faculty;Fellowship;Female;Fertility;Flare;follow-up;Formaldehyde;Funding;Gases;Geography;Gestational Diabetes;Grant;Health;HRK gene;Human;Hypertension;improved;Industry;Institution;Interdisciplinary Study;Internet;Late pregnancy;Life Style;Light;Live Birth;Low Birth Weight Infant;Measurement;Measures;Medical History;Menstrual cycle;Mentors;Metabolic Diseases;Methods;National Institute of Child Health and Human Development;National Institute of Environmental Health Sciences;Noise;novel;Oils;Outcome;Participant;participant enrollment;Particulate Matter;Pharmaceutical Preparations;Play;Policies;pollutant;Pollution;population health;Positioning Attribute;Postdoctoral Fellow;postpartum health;Postpartum Women;pre-doctoral;Pre-Eclampsia;Pregnancy;pregnancy hypertension;Pregnancy loss;Premature Birth;Probability;Production;professor;prospective;Prospective cohort;Prospective, cohort study;Province;Public Health;Public Health Schools;Questionnaires;Recording of previous events;recruit;Reporting;reproductive;Reproductive Health;Research;Research Design;Research Personnel;Resources;Risk;risk perception;Role;social stressor;sociodemographics;Spontaneous abortion;Surveys;Techniques;Time;time-to-pregnancy;TNFSF15 gene;Toluene;toxicant;Toxicology;Training;trying to conceive;United States;United States National Institutes of Health;Universities;volatile organic compound;Water;Woman;Work;Workplace

PROJECT_TITLE: A Preconception Cohort Study on Oil and Gas Development, Fertility, and Pregnancy


FUNDING_MECHANISM: OTHER RESEARCH-RELATED

NIH_SPENDING_CATS: Building Research Capacity at Institutions with Limited NIH Funding;Clinical Research;Clinical Trials and Supportive Activities;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Pediatric;Racial and Ethnic Minority Health Research;Rural Health;Social Determinants of Health

ORG_CITY: ALBUQUERQUE

ORG_DEPT: PEDIATRICS

ORG_NAME: UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR

ORG_STATE: NM

PHR: Project narrative: UNM Pediatric Clinical Trials Center will conduct multisite pediatric clinical trials research and assure that state-of-the-art clinical trials will be accessible to children living in rural or underserved communities in New Mexico. The Center will also work locally and nationally to ensure capacity building of research personnel to carry out trials with rigor. Collectively, these efforts will result in advancing knowledge in child health and better health outcomes in children.

PI_NAMEs: KONG, ALBERTA SUM-YU;RAISSY, HENGAMEH H (contact)

PROGRAM_OFFICER_NAME: RAJU, TONSE N

PROJECT_TERMS: Acceleration;Address;Adolescent;Affect;African American;Area;Asian;Award;Caring;Center for Translational Science Activities;Child;Child Health;Childhood;Clinical;clinical practice;Clinical Research;Clinical Sciences;clinical trial enrollment;clinical trial readiness;Clinical Trials;Clinical Trials Network;Collaborations;Communities;community engaged approach;Consent;Data;Dedications;Development;Development Plans;Dropout;Drug Formulations;Education;Enrollment;Ensure;Ethnic Population;experience;Extramural Activities;Faculty;Funding;Geography;Health;Health Benefit;Hispanic;Improve Access;improved;Infant;Infrastructure;innovation;Institution;investigator training;Knowledge;Location;medically underserved;Mentorship;Methods;Minority Groups;Monitor;Native Americans;neurodevelopment;New Mexico;new technology;Not Hispanic or Latino;novel;Obesity;operation;Outcome;outreach;Pacific Islander;Parents;participant retention;patient population;Patient Recruitments;pediatric patients;Pediatric Research;Perception;Perinatal;Physicians;Population;Population Heterogeneity;Positioning Attribute;postnatal;Poverty;prenatal;Principal Investigator;Process;Productivity;programs;racial population;Randomized;recruit;Research;Research Personnel;research study;Resources;Risk;Rural;rural area;Rural Community;Rural Population;Scientific Advances and Accomplishments;senior faculty;Site;skill acquisition;skills;Societies;Speed;study population;Time;Training;Translating;Underrepresented Populations;underserved area;underserved community;Underserved Population;Universities;Work;Workforce Development

PROJECT_TITLE: UNM Pediatric Clinical Trials Center in IDeA States Pediatric Clinical Trials Network


NIH_SPENDING_CATS: Aging;Arthritis;Autoimmune Disease;Bioengineering;Biomedical Imaging;Chronic Pain;Osteoarthritis;Pain Research;Physical Injury - Accidents and Adverse Effects;Rheumatoid Arthritis

ORG_CITY: STANFORD

ORG_DEPT: RADIATION-DIAGNOSTIC/ONCOLOGY

ORG_NAME: STANFORD UNIVERSITY

ORG_STATE: CA

PHR: PROJECT NARRATIVE Cellular senescence, the cessation of cell divisions with increasing age, has been recently identified as a major cause for the inability of the body to self-repair tissue damage due to trauma, infection/inflammation and degenerative disorders. The goal of our project is to test the first medical imaging biomarker for the detection of senescent cells, first in animal models and then in human volunteers. Results will be used to map age- dependent distributions of senescent cells in the body and monitor the efficacy of novel senolytic therapies.

PI_NAMEs: DALDRUP-LINK, HEIKE ELIZABETH (contact)

PROJECT_TERMS: 3-Dimensional;Affect;Age;age related;Animal Model;Arthritis;arthropathies;articular cartilage;Atlases;Attenuated;Autoradiography;beta-Galactosidase;Biological;Biological Markers;bone;Bone Marrow;Cartilage;Cartilage injury;Cartilage Matrix;cartilage repair;Cell Aging;Cell Cycle;Cell Cycle Arrest;Cell division;Cells;Characteristics;Chondrocytes;Chronic;clinical translation;Collaborations;Communities;cytokine;Data;Defect;Degenerative Disorder;Degenerative polyarthritis;Detection;Diagnosis;Diagnostic tests;Direct Costs;disability;Disease Progression;early childhood;Enzymes;Event;Facilities and Administrative Costs;Femur;first-in-human;Flow Cytometry;fluorescence imaging;Fluorine;glycation;Goals;healing;Health;Hip Osteoarthritis;Hospitalization;Human;human tissue;Human Volunteers;Hyaline Cartilage;hydrophilicity;Image;imaging approach;imaging biomarker;Imaging Device;Imaging technology;Immunohistochemistry;improved;In Situ;in situ imaging;in vivo;Individual;Infection;Inflammation;Inflammatory;Intravenous;intravenous administration;intravenous injection;Investigation;joint injury;Joints;Label;Link;lost earning;Macrophage;Magnetic Resonance Imaging;Malignant Neoplasms;Maps;Measures;Medical Care Costs;Medical Imaging;Monitor;Morbidity - disease rate;mouse model;Mus;Musculoskeletal;Musculoskeletal Diseases;musculoskeletal disorder diagnosis;Natural regeneration;novel;novel strategies;Outpatients;Oxidative Stress;Pain;Pathogenesis;Patients;Phase;Phase I Clinical Trials;Play;Positron-Emission Tomography;prevent;Process;Production;Proteins;radiotracer;Reactive Oxygen Species;Reference Standards;Reporter Genes;Research;Resolution;response;Rheumatoid Arthritis;Rodent;Role;senescence;senescence associated secretory phenotype;senescent cell;senolytics;Sensitivity and Specificity;Signal Transduction;Source;Specimen;Standardization;Stress;Synovial Cell;Synovial Membrane;System;Techniques;Telomere Shortening;Testing;Therapeutic;Thick;Time;tissue mapping;tissue repair;Tissues;Trauma;Traumatic Arthropathy;treatment response;United States;uptake;Visit;Visualization

PROJECT_TITLE: Cellular Senescence Network: New Imaging Tools for Arthritis Imaging


NIH_SPENDING_CATS: Clinical Research;Dissemination and Implementation Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Hematology;Infectious Diseases;Maternal Health;Maternal Morbidity and Mortality;Sepsis;Women's Health Research

ORG_CITY: DURHAM

ORG_DEPT: ANESTHESIOLOGY

ORG_NAME: DUKE UNIVERSITY

PHR: Maternal infection progressing to sepsis is the leading cause of direct maternal mortality in the United States with high preventability. The proposed research is relevant to public health because it focuses on a community co-led strategy to refine, test, and disseminate universal pregnancy-adjusted screening, diagnostic criteria, and treatment practices for sepsis to overall reduce maternal morbidity and mortality from maternal infection.

PI_NAMEs: BAUER, MELISSA  (contact);MAIN, ELLIOTT K

PROGRAM_OFFICER_NAME: LEE, SONIA S

PROJECT_TERMS: Address;Administrator;Advocate;barrier to care;Birth;California;Cardiovascular system;Caring;Cessation of life;Characteristics;Communities;Consolidated Framework for Implementation Research;Data;design;Diagnosis;Diagnostic;diagnostic criteria;diagnostic tool;Discipline of obstetrics;Disparity;Ensure;equity, diversity, and inclusion;ethnic minority;Event;evidence base;experience;Family;Family member;Focus Groups;Goals;Heterogeneity;Household;implementation barriers;improved;Individual;Infection;innovation;Intervention;Interview;intrapartum;Leadership;Lived experience;Low income;Maternal Health;maternal morbidity;Maternal Mortality;maternal outcome;Medical;Michigan;minority patient;Modeling;Morbidity - disease rate;mortality;Nurses;Outcome;patient advocacy group;patient population;Patients;Phase;Physicians;Physiological;Population;post implementation;Pregnancy;pregnant;preventable death;Process;Provider;Public Health;public health insurance;racial minority;Readiness;Research;Resources;response;screening;Screening procedure;Sepsis;severe maternal morbidity;Specificity;Standardization;Structure;Survivors;Testing;Time;United States

PROJECT_TITLE: Large-scale Implementation of Community Co-led Maternal Sepsis Care Practices to Reduce Morbidity and Mortality from Maternal Infection


NIH_SPENDING_CATS: Clinical Research;Maternal Health;Neurosciences;Pregnancy;Women's Health Research

ORG_CITY: LA JOLLA

ORG_DEPT: PATHOLOGY

ORG_NAME: UNIVERSITY OF CALIFORNIA, SAN DIEGO

PHR: PROJECT NARRATIVE Pregnancy relies on finely-tuned maternal immune adaptations to establish and maintain immune-tolerance to the semi- allogeneic fetus, which appear to be disrupted in women experiencing complications, such as preterm birth. Outside the context of pregnancy, the central nervous system can modulate systemic immunity via sympathetic signals but strikingly, its role in modulating the maternal immune dynamics during pregnancy remains unknown. In this proposal, we will investigate whether sympathetic (adrenergic) signals regulate innate immune responses during mouse, and human term and preterm pregnancies, with the aim to elucidate neuroimmune mechanisms of brain-pregnancy interaction – a key step to advance the early risk assessment and treatment of pathological pregnancies.

PI_NAMEs: STELZER, INA  (contact)

PROGRAM_OFFICER_NAME: ILEKIS, JOHN V

PROJECT_TERMS: Adrenergic Agents;Adrenergic Receptor;Age;Biological;Biological Assay;Biology;Blood;Blood specimen;Brain;Calcium;career development;Cells;Central Nervous System;Classification;Clinical Research;clinically relevant;Communication;Corticotropin-Releasing Hormone;CREB1 gene;cross immunity;Cytometry;designer receptors exclusively activated by designer drugs;diagnostic development;Diagnostic tests;Dopamine;Event;experience;fetal;Fetal Resorption;Fetus;Fiber;Genetic;Gestational Age;healthy pregnancy;high dimensionality;Human;Hydrocortisone;Hyperactivity;Immune;Immune system;Immune Tolerance;Immunity;Immunology;immunoregulation;in vivo;Inflammatory;Inflammatory Response;Innate Immune Response;Innate Immune System;innovation;Isoproterenol;Labor Onset;Ligands;Link;Machine Learning;machine learning method;maternal immune system;Methods;Modality;Modeling;Monitor;monocyte;mortality;mouse model;multiple omics;Mus;Nervous System;Nervous System control;neural;Neuroimmune;Neuroimmunomodulation;Neurologic;neuronal circuitry;Neurons;neuroregulation;Neurosciences;novel;Outcome;paraventricular nucleus;Pathologic;Pathology;Peripheral;peripheral blood;Phase;Phenylephrine;Photometry;Plasma;Population;Pregnancy;Pregnancy Complications;pregnancy immunology;Pregnancy Maintenance;Pregnancy Trimesters;Pregnant Women;Premature Birth;Premature Labor;programs;Proteins;Proteome;Proteomics;Regulation;Research;Research Project Grants;response;Risk Assessment;Role;Sampling;Signal Transduction;Stimulus;Stress;Supervision;Sympathectomy;Sympathetic Nervous System;System;Techniques;Testing;Third Pregnancy Trimester;Training;Ventral Tegmental Area;Weight;Woman

PROJECT_TITLE: Neuromodulation of maternal immune adaptations in pregnancy

STUDY_SECTION: NSS

STUDY_SECTION_NAME: NSS


NIH_SPENDING_CATS: Bioengineering;Cancer;Cervical Cancer;Clinical Research;Clinical Trials and Supportive Activities;Dissemination and Implementation Research;HPV and/or Cervical Cancer Vaccines;Immunization;Infectious Diseases;Pediatric;Prevention;Primary Health Care;Sexually Transmitted Infections;Vaccine Related;Women's Health Research

ORG_NAME: COLUMBIA UNIVERSITY HEALTH SCIENCES

PHR: PUBLIC HEALTH RELEVANCE  This proposed translational research seeks to design and assess, in a randomized controlled trial, text  message/automated phone reminders on timely human papillomavirus (HPV) vaccination in Ugandan  adolescents. This project, if successful, will outline an important foundation not only for other future trials for  HPV vaccine reminders in Uganda, but also for the potential use of text message reminders for other childhood  and adolescent vaccinations in Uganda, the larger Sub-Saharan African region, and in other low and middle income countries (LMICs).

PI_NAMEs: KITAKA, SABRINA BAKEERA;STOCKWELL, MELISSA S (contact)

PROGRAM_OFFICER_NAME: PEARLMAN, PAUL C

PROJECT_TERMS: Absenteeism;Achievement;Adolescent;adolescent health;Adopted;Africa;Africa South of the Sahara;African;authority;Capital;Caregivers;Cellular Phone;Child;Childhood;Cities;Clinic;Communities;Country;Death Rate;design;Development;Diagnosis;Disease;Dose;Education;Effectiveness;Electronics;Eligibility Determination;Enrollment;Event;Family;feasibility trial;Female;Female Adolescents;Foundations;Fright;Future;girls;Health;Health care facility;Household;Human Papilloma Virus Vaccination;Human Papilloma Virus Vaccine;Human Papillomavirus;Immunization;Immunization Programs;implementation measures;Income;informant;Intervention;Interview;Knowledge;Language;Leadership;literacy;low and middle-income countries;Malignant neoplasm of cervix uteri;Malignant Neoplasms;Measures;member;Methods;Nurses;Outcome;outreach;Paper;Parents;Pattern;Perception;Performance;Phase;pilot trial;Play;Policy Maker;Population;preadolescence;Preventive measure;Primary Prevention;Process;programs;prototype;public health relevance;Publishing;Randomized;Randomized, Controlled Trials;Research;Role;Schools;Series;Site;suburb;System;Target Populations;Telephone;Testing;Text Messaging;Time;Translational Research;Uganda;usual care arm;Vaccinated;Vaccination;vaccine safety;Vaccines;Voice;Woman;women's diagnosis;World Bank

PROJECT_TITLE: SEARCH: SMS Electronic Adolescent Reminders for Completion of HPV vaccination- Uganda


NIH_SPENDING_CATS: Breast Cancer;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Digestive Diseases;Genetics;Immunotherapy;Orphan Drug;Ovarian Cancer;Pancreatic Cancer;Rare Diseases;Women's Health Research

ORG_NAME: DANA-FARBER CANCER INST

PHR: PROJECT NARRATIVE Although PARP inhibition has transformed the treatment of homologous recombination (HR) repair-deficient cancers, strategies to prevent, or reverse acquired resistance represent an unmet medical need. To exploit the synthetic lethality of polymerase theta (POLq) and HR deficiency, the recently identified POLq inhibitor novobiocin (NVB) will be studied as monotherapy and in combination with talazoparib in BRCA-deficient, PARP inhibitor-sensitive and resistant preclinical models, including those that are immunocompetent. Results will be translated to early phase clinical trials, with the ultimate goal of improving outcomes for patients with advanced cancers harboring HR alterations.

PI_NAMEs: SHAPIRO, GEOFFREY I (contact)

PROGRAM_OFFICER_NAME: IVY, S PERCY

PROJECT_TERMS: advanced disease;Advanced Malignant Neoplasm;Antibiotics;antitumor effect;Base Excision Repairs;Biological;Biology;Biopsy;BRCA deficient;brca gene;Breast;Breast Cancer Model;cancer cell;Cancer cell line;Cell Line;Cells;Chronic;Clinical;Clinical Research;Clinical Trials;combinatorial;Complex;Data;Dependence;design;Development;DNA;DNA Damage;DNA Markers;Dose;Drug Kinetics;early phase clinical trial;Encapsulated;Excision;Genes;Genetically Engineered Mouse;Goals;homologous recombination;homologous recombination deficiency;Human;Immune;immune checkpoint blockade;Immunocompetent;improved outcome;In Vitro;in vivo;inhibitor;Knock-out;Link;Maintenance;Malignant Breast Neoplasm;Malignant neoplasm of ovary;Malignant neoplasm of pancreas;Malignant neoplasm of prostate;Malignant Neoplasms;Marketing;Mediating;Medical;mouse model;Mus;mutant;Mutation;Natural Immunity;Nature;Novobiocin;Ovarian;p53-binding protein 1;pancreatic cell line;PARP inhibition;Pathway interactions;patient derived xenograft model;Patient-derived xenograft models of breast cancer;Patient-Focused Outcomes;Patients;Pharmacodynamics;Phase;Phase I Clinical Trials;Poly(ADP-ribose) Polymerase Inhibitor;Polymerase;Pre-Clinical Model;preclinical study;Predisposition;prevent;Process;Proteins;Recommendation;refractory cancer;Residual state;Resistance;Resources;response;restoration;Secure;small molecule;Solid Neoplasm;Stimulator of Interferon Genes;success;Testing;Translating;tumor;tumor-immune system interactions;two-dimensional

PROJECT_TITLE: Novobiocin-mediated polymerase theta inhibition in homologous recombination repair-deficient cancers

STUDY_SECTION: DT

STUDY_SECTION_NAME: Developmental Therapeutics Study Section[DT]


FUNDING_MECHANISM: SBIR-STTR RPGS

NIH_SPENDING_CATS: Cancer;Colorectal Cancer;Digestive Diseases;Immunotherapy;Radiation Oncology

ORG_CITY: Hummelstown

ORG_NAME: BOBCATBIO, INC.

ORG_STATE: PA

PHR: PROJECT NARRATIVE This project develops a new immunotherapeutic technology that unleashes phagocytes to become key  components of defense against cancer, both eliminating tumors and preventing relapse. This technology  overcomes immunosuppressive mechanisms that preempts engagement of this potent immune program, and  uses phagocytes that are capable of both eating cancer cells and inducing long-lived anti-cancer immune  memory.

PI_NAMEs: MCCURLEY, NATHANAEL  (contact)

PROGRAM_OFFICER_NAME: FRANCA-KOH, JONATHAN C

PROJECT_TERMS: Acceleration;Acute;adaptive immune response;adaptive immunity;anti-cancer;Antibodies;Antigen Presentation;Antigens;Atlases;Biodistribution;Biological Assay;Body Weight;Breast;Businesses;cancer cell;cancer immunotherapy;Cancer Patient;Cancer Relapse;cancer therapy;cancer vaccination;carcinogenesis;CD47 gene;Chronic;Clinical;clinical application;clinical translation;Clinical Trials;Colorectal;Colorectal Cancer;Colorectal Neoplasms;commercialization;cytokine release syndrome;Cytotoxic T-Lymphocytes;Data;Dendritic Cells;Detection;Development;Development Plans;Disease remission;Distal;Dose;Eating;empowerment;Exhibits;extracellular;FDA approved;Funding;Goals;Head;Hematology;Human;Human Pathology;Immune;immune checkpoint blockade;Immune checkpoint inhibitor;immune clearance;Immune Evasion;Immunity;Immunocompetent;immunogenic;Immunologic Memory;Immunologic Surveillance;Immunophenotyping;Immunotherapeutic agent;Immunotherapy;In Situ;in situ vaccination;in vivo;Inflammatory;Inflammatory Response;Innate Immune Response;ITIM;Legal patent;Lesion;Licensing;Ligation;Liquid substance;Longevity;Lung;lymphoid organ;Macrophage;Malignant Breast Neoplasm;Malignant neoplasm of lung;Malignant neoplasm of pancreas;Malignant Neoplasms;Mediating;Melanoma;Minority;Modality;Modeling;Mus;neoantigens;neoplasm immunotherapy;Neoplasm Metastasis;Organ;Patients;Peripheral Blood Mononuclear Cell;Phagocytes;Phagocytosis;Phase;Phase I Clinical Trials;pre-clinical;preclinical efficacy;preempt;prevent;Production;programs;Protocols documentation;PTPNS1 gene;Radiation therapy;Reagent;Receptor Signaling;Recurrence;relapse prevention;Reproducibility;Research;response;Schedule;Skin;Small Business Technology Transfer Research;Solid Neoplasm;T memory cell;T-Cell Activation;T-Lymphocyte;Technology;Technology Transfer;Therapeutic;therapeutic development;Toxic effect;Toxicology;Translations;tumor;Tumor Antigens;Tumor Escape;Tumor Immunity;Tumor stage;Validation;Work;Xenograft procedure

PROJECT_TITLE: SIRPant Technology for anti-Cancer Immunity

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-OTC-L(12)B]


NIH_SPENDING_CATS: Clinical Research;Conditions Affecting the Embryonic and Fetal Periods;Diabetes;Genetics;Maternal Health;Maternal Morbidity and Mortality;Patient Safety;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Pregnancy;Preterm, Low Birth Weight and Health of the Newborn;Prevention;Women's Health Research

ORG_NAME: MASSACHUSETTS GENERAL HOSPITAL

PHR: High blood sugar in pregnancy leads to numerous complications in mothers and their infants but is usually not discovered until the late second or third trimester. We will use the latest advances in blood sugar measurement (continuous glucose monitoring and glycated markers) to study the relationship between pregnancy complications and blood sugar levels in the first trimester and across gestation. This work will lead to improved clinical approaches for gestational diabetes screening, diagnosis, and treatment that are simplified, personalized, and evidenced-based.

PI_NAMEs: POWE, CAMILLE ELISE (contact)

PROJECT_TERMS: Accounting;adverse outcome;adverse pregnancy outcome;Affect;age related;Albumins;Biological Assay;Birth trauma;Birth Weight;Blood Glucose;Blood specimen;Boston;Caring;Cesarean section;Classification;Clinical;Collaborations;Conceptions;Continuous Glucose Monitor;Data;Development;Diabetes Mellitus;Diagnosis;diagnostic criteria;Discipline of obstetrics;DNA;Dystocia;Early Diagnosis;early pregnancy;Enrollment;Erythrocytes;ethnic diversity;evidence base;experience;fetal;Fetal Macrosomia;Fingers;First Pregnancy Trimester;Genetic;Genetic Determinism;genetic profiling;Genetic Variation;Genomics;Genotype;Gestational Age;Gestational Diabetes;Glucose;glucose metabolism;glycation;Glycosylated hemoglobin A;Goals;Guidelines;Hematology;High Risk Woman;Hyperglycemia;improved;in utero hyperglycemia;Infant;Infrastructure;Insulin;Insulin Resistance;inter-individual variation;Investigation;Late pregnancy;Longitudinal Studies;Masks;Massachusetts;maternal outcome;Maternal Physiology;Measurable;Measurement;Measures;Modification;Monitor;Mothers;Multicenter Studies;National Institute of Diabetes and Digestive and Kidney Diseases;Neonatal;Neonatal Hypoglycemia;neonatal outcome;novel;obesity in children;observational cohort study;OGTT;Outcome;Participant;Patients;Perinatal;Physiological;Physiology;Population;Pregnancy;Pregnancy Complications;pregnant;Pregnant Women;Proteins;recruit;Research Personnel;response;Risk;Risk Factors;risk mitigation;screening;Second Pregnancy Trimester;Shoulder;Site;standard of care;Testing;Third Pregnancy Trimester;Time;tool;Umbilical Cord Blood;Woman;women's outcomes;Work

PROJECT_TITLE: Measuring Early Pregnancy Glycemia and Its Impact on Adverse Outcomes


NIH_SPENDING_CATS: Cancer;Digestive Diseases;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Prevention;Racial and Ethnic Minority Health Research;Rare Diseases;Social Determinants of Health;Stomach Cancer

PHR: Gastric cancer is the fifth most common cancer and the third leading cause of cancer death globally. In the U.S., there are stark disparities in gastric cancer incidence and mortality with many vulnerable minority communities bearing much of the disease burden. We propose to perform comparative modeling to provide critical evidence to improve the prevention and early detection of gastric cancer and cancer control policy.

PI_NAMEs: HUR, CHIN  (contact);LANSDORP-VOGELAAR, IRIS ;YEH, JENNIFER M.

PROGRAM_OFFICER_NAME: ZHU, LI

PROJECT_TERMS: Accounting;Address;Adult;Age;Antibiotic Resistance;Asian population;Black Populations;burden of illness;Calibration;Cancer Burden;cancer care;Cancer Control;Cancer Etiology;cancer health disparity;Cancer Model;cancer prevention;Caring;Categories;Cessation of life;Clinical;comparative;cost effective;cost effectiveness;Country;Curative Surgery;Data;Databases;Diagnosis;disease natural history;Disparity;early onset;Ethnic Origin;Excision;experience;Future;Gastric Adenocarcinoma;gastric cancer prevention;gastric intestinal metaplasia;Goals;Helicobacter Infections;Helicobacter pylori;high risk;high risk population;Hispanic Populations;improved;Incidence;Individual;innovation;Intervention;Lesion;Malignant Neoplasms;malignant stomach neoplasm;Methodology;minority communities;model development;Modeling;models and simulation;mortality;neglect;Neoplasms;Outcome;Patients;Persons;Policies;Population;population health;Positioning Attribute;premalignant;Prevalence;Prevention;Prevention strategy;Primary Care;Primary Prevention;progression risk;Prospective Studies;Publications;Race;racial population;Randomized, Controlled Trials;Recommendation;Regimen;Research;Risk;Risk Factors;screening;Screening for Gastric Cancer;Second Primary Cancers;Secondary Prevention;sex;simulation;Smoking;smoking cessation;Stomach;Study models;Subgroup;surveillance strategy;Survival Rate;tool;transmission process;trend;Variant;Vulnerable Populations;Work;World Health Organization;young woman

PROJECT_TITLE: Comparative modeling of gastric cancer disparities and prevention in the US and globally


NIH_SPENDING_CATS: Biotechnology;Breast Cancer;Cancer;Clinical Research;Women's Health Research

ORG_CITY: BALTIMORE

ORG_DEPT: PHARMACOLOGY

ORG_NAME: UNIVERSITY OF MARYLAND BALTIMORE

ORG_STATE: MD

PHR: This project will test the role of actin cortical contraction in microtentacle formation and the clustering of circulating breast tumor cells. The PI’s lab has established the counterbalance between MT extension and actin cortical contraction and identified specific molecular mechanisms to alter this balance. Innovative bioengineering approaches, animal models, PDX and live patient CTCs will be used to test these mechanisms of targeting the actin cortex to reduce microtentacles.

PI_NAMEs: MARTIN, STUART S (contact)

PROGRAM_OFFICER_NAME: AULT, GRACE S

PROJECT_TERMS: Acetylation;Actins;Adjuvant Chemotherapy;Affect;Animal Model;Antineoplastic Agents;Behavior;Biomedical Engineering;Blood capillaries;Blood Circulation;Breast Cancer Cell;Breast Cancer Treatment;Breast Epithelial Cells;Calcium Signaling;Cancer Etiology;Cancer Patient;cancer therapy;cell growth;Cell membrane;Cells;Cessation of life;Chemicals;Clinical Treatment;Clinical Trials;Clustered Regularly Interspaced Short Palindromic Repeats;CRISPR/Cas technology;Data;Desmosomes;Digitoxin;Disease;Distant;drug development;drug discovery;Epithelium;Equilibrium;Extracellular Matrix;FDA approved;Foundations;Genes;Genetic;Growth;Hour;Image;improved;In Vitro;in vivo;inhibitor;innovation;Invaded;Lung;Lymphatic;MCAM gene;mechanical properties;mechanotransduction;Mediating;Metastatic breast cancer;Metastatic/Recurrent;Methods;Microfluidics;Microscopy;Microtubule Stabilization;Microtubules;Modeling;Molecular;Motility;Mus;Neoadjuvant Therapy;Neoplasm Circulating Cells;Neoplasm Metastasis;neoplastic cell;novel therapeutics;Operative Surgical Procedures;Organ;Ouabain;Outcome;Paclitaxel;Pathway interactions;patient derived xenograft model;Patients;Pharmaceutical Preparations;Phosphotransferases;Post-Translational Protein Processing;precision medicine;pressure;Prognosis;Proteins;Regulation;response;Risk;Role;side effect;standard of care;Surface;System;targeted cancer therapy;Techniques;Testing;Therapeutic;therapeutic target;Tissues;Translating;treatment strategy;triple-negative invasive breast carcinoma;Tubulin;tumor;Tumor Promotion;whole animal imaging;Xenograft procedure;Zebrafish

PROJECT_TITLE: Tubulin microtentacles in detached mammary epithelial cells

STUDY_SECTION_NAME: Mechanisms of Cancer Therapeutics - 2 Study Section[MCT2]


NIH_SPENDING_CATS: Clinical Research;Conditions Affecting the Embryonic and Fetal Periods;Contraception/Reproduction;Diabetes;Maternal Health;Maternal Morbidity and Mortality;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Pregnancy;Prevention;Women's Health Research

ORG_CITY: NEW HAVEN

ORG_DEPT: OBSTETRICS & GYNECOLOGY

ORG_NAME: YALE UNIVERSITY

ORG_STATE: CT

PHR: Project Narrative To date, diagnosis of gestational diabetes mellitus (GDM) has been relegated to the end of the second trimester or early in the third trimester; yet, it is possible that dysglycemia occurring even earlier in pregnancy may impact both maternal and neonatal outcomes. Furthermore, while it is the gold standard, the oral glucose tolerance test (OGTT) used to diagnose GDM has many limitations: 1- it is not clear that the OGTT represents true physiologic glucose variation with the glucose load provided, 2- debate exists as to what cut-offs should be employed for diagnosis of GDM, 3- it is unclear if earlier performance of OGTT can use the same thresholds for diagnosis and whether earlier diagnosis can be used to improve important maternal and neonatal outcomes. Therefore, the current proposal seeks to assess whether blinded continuous glucose monitors can be employed to diagnose GDM and, potentially, allow for earlier detection of dysglycemia while also conducting rigorous metabolic assessments of women during the course of pregnancy to allow better characterization of the metabolic changes that occur with GDM.

PI_NAMEs: MERRIAM, AUDREY  (contact);SHERR, JENNIFER LYNN

PROJECT_TERMS: adiponectin;Adverse event;adverse maternal outcomes;adverse pregnancy outcome;Affect;Age;Beta Cell;Biological Assay;Biological Markers;Birth trauma;Blinded;Body mass index;C-Peptide;Calibration;Cell Death;Childhood;cohort;congenital anomaly;Continuous Glucose Monitor;Data;Data Collection;Detection;Development;Diagnosis;Dystocia;Early Diagnosis;Early treatment;Eligibility Determination;Ethnic Origin;Fingers;First Pregnancy Trimester;Follow-Up Studies;Frequencies;Functional disorder;Funding;Generations;Gestational Age;Gestational Diabetes;Glucagon;Glucose;glucose sensor;glycation;high risk;High Risk Woman;Hour;Hypoglycemia;improved;Individual;Infant;Insulin;Insulin Resistance;insulin sensitivity;intrauterine environment;Knowledge;Leptin;Maternal Age;Maternal complication;maternal diabetes;maternal outcome;maternal weight;Measurement;Metabolic;metabolic abnormality assessment;metabolic profile;Methods;Monitor;monitoring device;Mothers;neonatal outcome;non-diabetic;Non-Insulin-Dependent Diabetes Mellitus;Observational Study;offspring;OGTT;Outcome;outcome prediction;parity;Participant;Pattern;Performance;perinatal outcomes;Physiological;Plasma;Postpartum Period;Pre-Eclampsia;Pregnancy;Pregnancy Trimesters;Pregnant Women;prepregnancy;Process;prospective;Race;Recommendation;Risk;Risk Factors;Sample Size;screening;Second Pregnancy Trimester;Shoulder;Spontaneous abortion;standard of care;stillbirth;Subgroup;Testing;therapy outcome;Third Pregnancy Trimester;Time;Variant;Visit;Weight Gain;Woman

PROJECT_TITLE: eMOM: enhanced Monitoring to Optimize Maternal Diabetes detection


ADMINISTERING_IC: MH

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Clinical Research;Mental Health;Neurosciences

PHR: Functional magnetic resonance imaging (fMRI) has a great potential to accurately measure neuronal activity over the whole human brain, but because it is a measure of blood oxygenation changes it is greatly affected by local microstructural and microvascular properties of the cortex. Due to recent technical advances, fMRI can now achieve much higher levels of detail, allowing investigation of functional changes within the cerebral cortex, which has a layered structure, with each layer having a different role in the neuronal circuit. In this project we will remove fMRI signal biases due to tissue microstructure and microvasculature by combining advanced MRI methods with histology data from human brain specimens, to allow fMRI to more accurately measure neuronal activity including functional changes across cortical layers.

PI_NAMEs: BLAZEJEWSKA, ANNA I (contact)

PROGRAM_OFFICER_NAME: BENNETT, YVONNE MARIE

PROJECT_TERMS: Accounting;Address;Affect;Anatomy;Animals;Area;area striata;Atlases;Award;Back;biomedical imaging;Blood;Blood flow;Blood Vessels;Brain;brain circuitry;BRAIN initiative;Brain region;career;Cell Nucleus;cerebral blood volume;Cerebral cortex;Cerebrum;Characteristics;collaborative environment;computer science;Consultations;Contrast Media;Data;Data Analyses;density;experience;Experimental Designs;experimental study;extrastriate visual cortex;Face;Feedback;Functional Imaging;Functional Magnetic Resonance Imaging;General Hospitals;Goals;Heme;Histologic;histological specimens;Histology;Human;human data;Image;imaging facilities;Imaging Techniques;in vivo;in vivo imaging;indexing;Individual;Investigation;Iron;Knowledge;luminance;Magnetic Resonance Imaging;Maps;Masks;Massachusetts;Measurement;Measures;medical schools;Mentors;Methodology;Methods;Microanatomy;millimeter;Modeling;monocular;Myelin;Neocortex;neural;neuronal circuitry;Neurons;Neurosciences;novel;Output;Pathway interactions;Phase;Physics;programs;Property;regional difference;Research;Research Personnel;Resolution;response;Role;Signal Transduction;skills;Source;Specificity;Specimen;Stains;Stimulus;Structure;System;Techniques;Technology;Testing;Tissue Model;Tissues;Training;Variant;Visual Cortex

PROJECT_TITLE: Relating functional MRI to neuronal activity: accounting for effects of microarchitecture


NIH_SPENDING_CATS: Behavioral and Social Science;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Colorectal Cancer;Complementary and Integrative Health;Digestive Diseases;Prevention

ORG_CITY: Aurora

ORG_NAME: UNIVERSITY OF COLORADO DENVER

ORG_STATE: CO

PHR: PROJECT NARRATIVE Coping with metastatic colorectal cancer (mCRC) is a highly distressing experience for patients as well as their partners. Clinical interventions that offer brief, accessible, and effective coping tools to both members of the couple may significantly improve the quality of life of both patient and partner, thus addressing an important gap in current clinical care. The proposed research offers to fill this gap by developing and piloting a brief, couple- based mindfulness intervention aimed to reduce distress and improve the quality of life of patients with mCRC as well as their partners.

PI_NAMEs: ZIMMARO, LAUREN A. (contact)

PROGRAM_OFFICER_NAME: RADAEV, SERGEY

PROJECT_TERMS: active method;Address;Affect;Area;Attention;Awareness;Behavioral;Belief;Body Image;cancer care;Cancer Patient;Cancer Survivor;Cancer Survivorship;care giving burden;Chronic;Clinical;clinical care;clinically significant;cognitive interview;colon cancer patients;Colorectal Cancer;Communication;Compassion;Continuance of life;coping;Couples;Data;design;Development;Diagnosis;Distress;Education;Educational process of instructing;effective intervention;emotional distress;Emotions;end of life;Evaluation;evidence base;Excision;expectation;experience;Fatigue;Fecal Incontinence;Feces;Future;gastrointestinal symptom;Goals;improved;Individual;innovation;Intervention;intervention delivery;intervention effect;intervention refinement;Interview;Intestines;intimate behavior;Length;Life;Light;Love;Malignant Neoplasms;Measures;Mediator;member;metastatic colorectal;mindfulness;mindfulness intervention;Nature;Operative Surgical Procedures;Ostomy;Outcome;Participant;Patients;Perception;Persons;physical symptom;pilot trial;post intervention;preference;primary outcome;Protocols documentation;psychologic;psychosocial;psychosocial outcome;Quality of life;Randomized;randomized trial;Randomized, Controlled Trials;Reporting;Research;Research Personnel;Research Project Grants;research study;Sampling;Science;Sexuality;Shame;side effect;skills;skills training;Structure;Surveys;therapy design;Time;tool;Training;Treatment Efficacy;trend;videoconference

PROJECT_TITLE: Addressing Colorectal Cancer-Related Distress: Developing and Evaluating a Couple-Based Mindfulness Intervention

STUDY_SECTION: NCI

STUDY_SECTION_NAME: Career Development Study Section (J)[NCI-J]


ED_INST_TYPE: BIOMED ENGR/COL ENGR/ENGR STA

NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Biotechnology;Clinical Research;Digestive Diseases;HIV/AIDS;Hepatitis;Hepatitis - B;Infectious Diseases;Liver Disease;Pediatric;Precision Medicine;Prevention

ORG_CITY: PHILADELPHIA

ORG_DEPT: ENGINEERING (ALL TYPES)

ORG_NAME: UNIVERSITY OF PENNSYLVANIA

PHR: Project Narrative: The proposed effort will result in a new generation of home / point-of-care molecular (nucleic acid) - based diagnostic devices to monitor viral load of HIV in patients undergoing therapy and high-sensitivity screening for HIV infection in individuals at risk, including during the seroconversion period, as well as newborns of AIDS- infected mothers when antibody tests are ineffective. The proposed device will foster improved healthcare both in developed countries and in resource-limited settings. The technology platform is adaptable for the detection of other infectious diseases and amenable to multiplexing and detection of co-infections that are common in AIDS patients.

PI_NAMEs: BAU, HAIM H (contact)

PROGRAM_OFFICER_NAME: MAJJI, SAI PRASANNA

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Address;Adherence;Adult;Agreement;Antibodies;antiretroviral therapy;Behavior;Benchmarking;beta Globin;Blood;Blood specimen;Blood Volume;burden of illness;Caring;Cellular Phone;Centers for Disease Control and Prevention (U.S.);Child;Clinic;Clinical;clinical research site;co-infection;Communicable Diseases;Computer software;cost;Counseling;Custom;design;Detection;detection limit;Developed Countries;Development;Devices;Diagnosis;Diagnostic;Diagnostic Equipment;Diagnostic Sensitivity;Drug resistance;drug resistance development;Dryness;Early treatment;Electricity;empowerment;Encapsulated;Engineering;Fingers;Fostering;Freeze Drying;Generations;Goals;Healthcare;Hepatitis B;Hepatitis C;HIV;HIV Infections;HIV Seronegativity;HIV-1;Home;Human immunodeficiency virus test;improved;Incubated;Individual;individualized medicine;Infant;Infection;Infusion procedures;Institutional Review Boards;Instruction;instrument;instrumentation;Intervention;large scale production;Laws;Life;Manuals;Medical;Mental Health;Molecular;Monitor;Mothers;multiplex detection;neutralizing antibody;Newborn Infant;novel;Nucleic Acids;operation;Oral;Paraffin;Partner in relationship;pathogen;Patients;Performance;personalized medicine;Phase;Plasma;point of care;prevent;Process;prototype;Public Health;rapid detection;Reaction;Reagent;Refrigeration;Reporting;Research;Research Personnel;resistant strain;Resource-limited setting;response;Risk;Sampling;Schools;Scientist;screening;self testing;seroconversion;Signal Transduction;smartphone application;Specimen;System;Target Populations;technology platform;Temperature;Test Result;Testing;transmission process;usability;Viral Load result;viral rebound;Viremia;web app;Whole Blood

PROJECT_TITLE: Minimally-instrumented home HIV detection and care linkage system


ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease Related Dementias (ADRD);Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Behavioral and Social Science;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Cost Effectiveness Research;Dementia;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Neurodegenerative;Neurosciences;Prevention;Primary Health Care;Racial and Ethnic Minority Health Research;Social Determinants of Health

ORG_CITY: CHICAGO

ORG_NAME: NORTHWESTERN UNIVERSITY AT CHICAGO

ORG_STATE: IL

PHR: Cognitive deficits and impairment, including Alzheimer’s disease and related dementias (ADRD), are highly prevalent among older adults, with higher rates among Black and Hispanic/Latino individuals, and have devastating consequences to families and entire communities. Responding to increasing calls for early detection of cognitive impairment in everyday clinical settings, our proposed trial will offer primary care practices serving marginalized communities an affordable, scalable means to detect and care for those affected.

PI_NAMEs: WOLF, MICHAEL S (contact);YOSHINO BENAVENTE, JULIA ;YOUNG, STEPHANIE RUTH

PROGRAM_OFFICER_NAME: HOMMER, REBECCA EVE

PROJECT_TERMS: Address;Adult;Affect;Alzheimer's Disease;Alzheimer's disease related dementia;Ambulatory Care;arm;Award;Behavioral;Black race;care coordination;Caregivers;Caring;Clinic;Clinical;Cognitive deficits;Communities;Cost Analysis;cost effectiveness;Decision Making;Dedications;Dementia;design;Detection;Diagnosis;Disparity;Early Diagnosis;Early identification;effectiveness testing;Electronic Health Record;Ethnic Origin;Etiology;evidence base;experience;Family;Future;Goals;Health;health disparity;health management;Health system;Hispanic;human old age (65+);Impaired cognition;improved;Latino;Latino Population;Link;low socioeconomic status;Managed Care;marginalization;marginalized community;Medical;medically underserved;member;mild cognitive impairment;National Institute of Neurological Disorders and Stroke;Neighborhood Health Center;Neurologic;older adult;patient population;Patient-Centered Care;Patients;Population;pragmatic trial;Primary Care;primary care practice;primary care provider;primary care setting;primary care visit;Protocols documentation;public health priorities;Quality of life;Race;racial minority;Randomized;Recommendation;response;Self Administration;Services;Standardization;symposium;Technology;treatment as usual;trial comparing;underserved community;United States National Institutes of Health;Visit

PROJECT_TITLE: Primary Care Detection of Cognitive Impairment Leveraging Health and Consumer Technologies in Underserved Communities: The MyCog Trial


NIH_SPENDING_CATS: Aging;Bioengineering;Biomedical Imaging;Cancer;Clinical Research;Networking and Information Technology R&D (NITRD);Prevention;Prostate Cancer;Urologic Diseases

ORG_CITY: MINNEAPOLIS

ORG_NAME: UNIVERSITY OF MINNESOTA

PHR: Successful completion of this proposal will result in the realization of a computer aided detection (CAD) system for detecting and assessing the aggressiveness of prostate cancer through the use of novel user-independent evaluation of quantitative multiparametric MRI. The system will consist of a novel quantitative prostate phantom and software pipelines. These developments overcome the major roadblocks limiting the clinical translation of quantitative imaging methods by developing 1) a comprehensive set of tools to validate the quantitative parameters of interest and 2) novel CAD systems with the potential to significantly impact the management of the disease by improving biopsy targeting in the short term and providing critical information to confidently manage men on active surveillance in the long term.

PI_NAMEs: METZGER, GREGORY JOHN (contact)

PROGRAM_OFFICER_NAME: MARQUEZ, GUILLERMO

PROJECT_TERMS: Address;Adoption;Affect;analysis pipeline;Anatomy;Biological Markers;Biopsy;blind;Blood Tests;Cancer Detection;Cancer Etiology;Cessation of life;Clinic;Clinical;clinical application;clinical translation;Clinical Trials;Collaborations;computer aided detection;Computer software;computer-assisted diagnostics;cost;Data;Data Set;design;Detection;detection platform;Development;Devices;Diagnosis;diagnostic platform;Diagnostic Procedure;diagnostic tool;Digital Rectal Examination;Disease;Disease Management;Ensure;Environment;Evaluation;experience;Future;Goals;Healthcare Systems;Histopathology;Image Analysis;imaging modality;Imaging Phantoms;improved;Incontinence;industry partner;interest;Lesion;Life;Location;Magnetic Resonance Imaging;male;Malignant neoplasm of prostate;Malignant Neoplasms;Manufacturer;Maps;Measures;men;Methods;Modeling;new technology;non-invasive monitor;novel;Outcome;Patients;Performance;Physicians;Positioning Attribute;predictive modeling;Prevalence;Procedures;Process;Prostate;prostate lesions;Prostate-Specific Antigen;Protocols documentation;Quality of life;Quantitative Evaluations;quantitative imaging;radiologist;Radiology Specialty;Reporting;Reproducibility;risk stratification;Sampling;Screening for Prostate Cancer;Sensitivity and Specificity;serum PSA;Site;System;Technology;tool;Training;Translating;Translations;Transrectal Ultrasound;tumor specificity;Validation;validation studies;Vendor;visual map

PROJECT_TITLE: Computer Aided Diagnostic System for Prostate Cancer Detection Using Quantitative Multiparametric MRI


NIH_SPENDING_CATS: Anxiety Disorders;Behavioral and Social Science;Brain Disorders;Clinical Research;Data Science;Depression;Genetics;Health Services;Human Genome;Machine Learning and Artificial Intelligence;Major Depressive Disorder;Mental Health;Mental Illness;Networking and Information Technology R&D (NITRD);Patient Safety;Prevention;Serious Mental Illness;Social Determinants of Health;Suicide

ORG_CITY: ROCHESTER

ORG_NAME: MAYO CLINIC ROCHESTER

PHR: PROJECT NARRATIVE Major depression, anxiety disorders and substance use disorder are highly prevalent in the general population and have a huge societal burden. Given the substantial heritability of these conditions and their polygenic architecture, there is increasing interest in using quantitative polygenic risk scores (PRSs) for risk stratification. This study will analyze "big data" from electronic health records linked to genetic data to evaluate the prediction of clinical outcomes using PRSs and social determinants of health.

PI_NAMEs: BIERNACKA, JOANNA M (contact)

PROGRAM_OFFICER_NAME: PEVSNER, JONATHAN ABRAM

PROJECT_TERMS: Address;Anxiety;Anxiety Disorders;Applied Genetics;Architecture;Big Data;biobank;care outcomes;Clinic;Clinical;clinical care;Clinical Data;clinical practice;cohort;Collaborations;comorbidity;Complex;Computerized Medical Record;cost;Data;Data Set;deep learning;Depressive disorder;Disease;disorder risk;Education;Electronic Health Record;Employment;Environmental Risk Factor;Epidemiology;European ancestry;Evaluation;Feeling suicidal;Functional impairment;Funding;General Population;Genetic;Genetic Research;genetic risk factor;Genetic Variation;genome wide association study;genome-wide;Genotype;Geography;Goals;health care service utilization;Health system;Heritability;improved;Individual;infancy;inpatient psychiatric treatment;interest;Knowledge;large datasets;Link;Machine Learning;Major Depressive Disorder;Medical;Medical center;Mental disorders;Mental Health;Methods;Modeling;mortality risk;Natural Language Processing;neuropsychiatric disorder;New York City;Outcome;Participant;Patients;Performance;Persons;Phenotype;pleiotropism;polygenic risk score;Population;population based;Population Heterogeneity;predict clinical outcome;psychiatric comorbidity;psychogenetics;Research;response;Risk;risk prediction;risk stratification;Role;Sampling;Scoring Method;Site;social health determinants;structured data;Substance Use Disorder;suicidal behavior;Suicide attempt;Symptoms;Text;therapy resistant;trait;treatment-resistant depression;Variant

PROJECT_TITLE: 2/4: Leveraging EHR-linked biobanks for deep phenotyping, polygenic risk score modeling, and outcomes analysis in psychiatric disorders

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-PSE-Z(60)C]


ADMINISTERING_IC: CE

IC_NAME: NATIONAL CENTER FOR INJURY PREVENTION AND CONTROL

ORG_NAME: UNIVERSITY OF MICHIGAN AT ANN ARBOR

PHR: Project Narrative Firearm related injuries are the leading cause of death among youth in the United States, with firearms accounting for over half of our nation’s suicide deaths. Rates of firearm-related suicides among rural youth are increasing at an alarming rate and although safe firearm storage reduces risk, few interventions exist that are tailored to rural communities where firearms are prevalent and an important part of community and family culture. Store Safely, a culturally tailored multi-component primary prevention strategy for rural families will be tested using a hybrid two effectiveness-implementation design to examine its impact on family firearm storage and to determine the most effective dissemination strategies for this highly scalable intervention.

PI_NAMEs: EWELL FOSTER, CYNTHIA (CINDY)  (contact)

PROJECT_TITLE: RFA-CE-23-006, Store Safely: Firearm injury prevention for rural families


ADMINISTERING_IC: GH

IC_NAME: Center for Global Health

ORG_CITY: KISUMU

ORG_COUNTRY: KENYA

ORG_FIPS: KE

ORG_NAME: SAFE WATER AND AIDS PROJECT (SWAP)

PHR: Project Narrative Schistosomiasis (SCH) and soil-transmitted helminthiasis (STH) are major global public health problems. SCH presents with a range of morbidities, and although recent years have witnessed a scale-up of MDA for SCH control worldwide, no single direct morbidity marker has been adopted to monitor the clinical impact of these interventions. It is widely appreciated that the critical infection levels associated with SCH morbidity are poorly understood and evidence-based targets for control are lacking. On the other hand, while MDA has contributed to reduction of prevalence and intensity of SCH & STH over the decades, it is acknowledged that MDA alone is unlikely to interrupt transmission of these diseases. Other control measures such as provision of water, sanitation, and hygiene (WASH) are needed, but the threshold of WASH levels/indicators that are associated with the greatest impact of MDA need to be ascertained. Proper disease surveillance encompassing robust monitoring and evaluation (M&E) activities for all control measures including WASH and vector control remains a key ingredient in ensuring the success of control programs and activities against these diseases. Planning for control interventions including MDA to control S. mansoni requires accurate testing and mapping to determine local parasite prevalence. Although Kato-Katz is recommended by the WHO for detection of intestinal schistosomiasis, there is increasing appreciation that the sensitivity of Kato-Katz stool analysis will continue decline, especially as more MDA programs are expanded and progressively lower egg densities are observed. New and improved diagnostics are therefore needed to ensure and to support successful disease surveillance, M&E of control programs. At the same time, pharmacovigilance for new treatments or formulations and other alternative control interventions including snail control also remain central in efforts to interrupt transmission. The proposed 4 studies that are interconnected and targeting SCH & STH in western Kenya will evaluate and monitor morbidity, evaluate new diagnostic tools and interventions including WASH and snail monitoring to reduce or interrupt transmission, and evaluate safety, efficacy and impact of new treatments or new formulations of existing treatments for SCH as they become available.

PI_NAMEs: ODIERE, MAURICE REUBEN (contact)

PROJECT_TITLE: RFA-GH-22-001, Monitoring morbidity, evaluation of new diagnostic tools; interventions to reduce or interrupt transmission, and improving surveillance for intestinal schistosomiasis.


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

NIH_SPENDING_CATS: Antimicrobial Resistance;Biotechnology;Emerging Infectious Diseases;Infectious Diseases

ORG_CITY: PALMETTO BAY

ORG_NAME: TOP BIOSCIENCES, LLC

ORG_STATE: FL

PHR: Antibiotic resistance is a critical threat to both US and global public health. The growing ineffectiveness of antibiotics in combating bacterial infections significantly undermines our capacity to treat common illnesses and could potentially lead to more untreatable medical conditions. The proposed research aims to create and develop a set of three high-throughput screening assays for commercial use, streamlining the discovery of novel antibiotics that poison bacterial DNA gyrase and address this pressing public health threat.

PI_NAMEs: LENG, FENFEI  (contact)

PROGRAM_OFFICER_NAME: BALAKRISHNAN, KRISHNA B

PROJECT_TERMS: Address;American;Antibiotic Resistance;Antibiotics;Antimicrobial Resistance;Bacteria;Bacterial DNA;Bacterial Infections;bacterial resistance;Biochemical;Biological Assay;Black Box;Bone Marrow Transplantation;Centers for Disease Control and Prevention (U.S.);Cessation of life;Chemicals;Chemotherapy-Oncologic Procedure;Clinical;combat;commercialization;commercialization readiness;Complex;cost;Development;DNA;DNA Damage;DNA Gyrase;DNA Topoisomerases;drug discovery;Drug Targeting;drug-like compound;Enzymes;Exonuclease;Fluorescence;fluoroquinolone resistance;Fluoroquinolones;Future;Goals;high risk;high throughput screening;Human;Infection;inhibitor;innovation;Libraries;Mediating;Medical;miniaturize;novel;novel antibiotic class;Operative Surgical Procedures;Organ;pathogen;Patients;Phase;plasmid DNA;Poison;Poisoning;Public Health;Relaxation;Research;Resistance to infection;scaffold;screening;side effect;small molecule inhibitor;small molecule libraries;Stains;Topoisomerase;Topoisomerase II;Topoisomerase Inhibitors;World Health Organization

PROJECT_TITLE: High Throughput Screening to Discover Bacterial DNA Gyrase Poisoning Inhibitors

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-J (10)]


NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Chronic Pain;Digestive Diseases;Neurosciences;Pain Research;Prevention

ORG_CITY: RESEARCH TRIANGLE PARK

ORG_NAME: DIGNIFY THERAPEUTICS, LLC

PHR: Narrative This application proposes new therapies to prevent or reduce fecal incontinence and fecal urgency in the elderly. Fecal incontinence is a major reason for institutionalization of the elderly. Currently there are no satisfactory treatments.

PI_NAMEs: THOR, KARL B (contact)

PROGRAM_OFFICER_NAME: LUNSFORD, DWAYNE

PROJECT_TERMS: Absence of pain sensation;absorption;Accidents;Action Potentials;Adult Diapers;age related;aged;Agonist;Analgesics;analog;Animals;Anus;awake;Behavior;Binding;Body Regions;Capsaicin;Caregivers;Cations;Childbirth;Chronic;Clinical;clinically significant;Colitis;Colorectal;colorectal distension;Constipation;Defecation;Dementia;depressive symptoms;desensitization;Diarrhea;Dose;Elderly;Emotional;Esthesia;Exhibits;Fecal Incontinence;Feces;Fiber;Formulation;Frequencies;Gene Proteins;Home;Hour;Incontinence;Inflammatory;inflammatory pain;insight;Institution;Institutionalization;Irritable Bowel Syndrome;irritation;Local Anesthetics;Mediating;Mental Health;Methods;Modeling;Multiple Sclerosis;Mus;Nerve Fibers;neurochemistry;Neurologic;Nociception;novel therapeutics;Nursing Homes;Odors;osteoarthritis pain;Pain;pain sensation;pain symptom;painful neuropathy;Pathologic;patient home care;Patients;Persons;Pharmaceutical Preparations;Pharmacotherapy;Phase;Phenotype;Population;pre-clinical;preference;prevent;Prevention;Process;Property;Protocols documentation;psychological distress;Rattus;receptor;Rectal Administration;Rectum;reduce symptoms;Reflex action;Reproducibility;Resiniferatoxin;response;Risk;Sensory;Shame;side effect;Small Business Innovation Research Grant;social relationships;Spinal Injuries;Stains;Stigmatization;Suppositories;Symptoms;System;Testing;Therapeutic;Time;translational model;TRPV1 gene;Update;Woman

PROJECT_TITLE: Therapy for Fecal Incontinence and FecalUrgency

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 KUDS-R (10)]


ADMINISTERING_IC: AG

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Aging;Arthritis;Behavioral and Social Science;Bioengineering;Biomedical Imaging;Chronic Pain;Clinical Research;Clinical Trials and Supportive Activities;Disability Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Osteoarthritis;Pain Research;Social Determinants of Health

ORG_CITY: TRUMBULL

ORG_NAME: ZETROZ SYSTEMS, LLC

PHR: Project Narrative: This SBIR Phase IIB project continues development of the first home-use NSAID-enhanced sonophoresis patch for use by the active aging population with knee Osteoarthritis. The innovative treatment has been evaluated in laboratory, clinical-research and real-world settings demonstrating superior efficacy to reduce pain and restore function. We will now complete remaining regulatory requirements for servicing the diverse aging population, establish coding and policy for the technology to provide broader access to the treatment, and demonstrate a clear clinical advantage over standardized intra-articular corticosteroid injections in the symptomatic management of knee Osteoarthritis.

PI_NAMEs: LEWIS, GEORGE KENNETH (contact)

PROGRAM_OFFICER_NAME: JOSEPH, LYNDON

PROJECT_TERMS: Acceleration;Achievement;active method;Adoption;Adrenal Cortex Hormones;Adult;Adverse effects;Affect;age acceleration;Age Years;Aging;aging population;arm;Arthritis;articular cartilage;Articular Range of Motion;barrier to care;biomaterial compatibility;Businesses;Cardiovascular system;Caring;Cartilage;celecoxib;Centers for Disease Control and Prevention (U.S.);Client satisfaction;Clinical;Clinical effectiveness;Clinical Research;Code;commercialization;comorbidity;Complex;Cost Analysis;Coupled;Coupling;cytotoxicity;Data;Degenerative polyarthritis;design;Development;Devices;Diathermy;Diclofenac;disability;Disease;Drug Utilization;Economics;Effectiveness;efficacy study;Elderly;Engineering;ethnic diversity;Ethnic Origin;Exercise;Exhibits;experience;FDA approved;Formulation;functional improvement;functional restoration;gastrointestinal;Gel;geographic barrier;Goals;Growth;Health;Health Benefit;Health Care Costs;Health Professional;Health Services Accessibility;Healthcare Systems;Histopathology;Home;Hour;Human;Human body;human old age (65+);human subject;implementation study;improved;improved mobility;indexing;Individual;Infection;Injections;innovation;Insurance Carriers;Intra-Articular Injections;joint function;Kidney;Knee Osteoarthritis;knee pain;Laboratories;Life;Life Cycle Stages;Location;manufacture;Marketing;Measures;Medical;Medicare;Medicare/Medicaid;Methods;microbial;minimal risk;Mobility decline;Modeling;National Institute on Aging;non-opioid analgesic;Non-Steroidal Anti-Inflammatory Agents;novel;Office Visits;Oral;osteoarthritis pain;Outcome Measure;Pain;Pain management;pain reduction;pain relief;pain scale;Participant;participant enrollment;patient population;Patient-Focused Outcomes;Patients;Penetration;Performance;Pharmaceutical Preparations;Pharmacologic Substance;Pharmacology;Phase;Placebo Control;placebo group;Placebos;Policies;primary outcome;programs;Quality of life;radiological imaging;Randomized;Regulatory Pathway;Reporting;Risk;Safety;Salicylic Acids;Saline;Series;Services;side effect;Site;skin irritation;Small Business Innovation Research Grant;Socioeconomic Status;standard of care;Standardization;Statistical Data Interpretation;symptom treatment;Symptoms;System;Technology;technology validation;Testing;Therapeutic;Tissues;Topical application;Transdermal substance administration;treatment group;ultrasound;United States;United States National Institutes of Health;Validation;Walking;Water;Western Ontario and McMaster Universities Arthritis Index

PROJECT_TITLE: Daily & Localized NSAID Sonophoresis for Symptomatic Treatment of Knee Osteoarthritis

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MSOS-A (11)]


ADMINISTERING_IC: HG

IC_NAME: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

NIH_SPENDING_CATS: Breast Cancer;Cancer;Genetic Testing;Genetics;Human Genome;Precision Medicine;Prevention;Women's Health Research

ORG_CITY: KATY

ORG_NAME: CONSTANTIAM BIOSCIENCES INC.

ORG_STATE: TX

PHR: PROJECT NARRATIVE Constantiam Biosciences will enhance and develop Varify, a cutting-edge platform that translates complex experimental data into actionable insights for improved medical decision-making. By harnessing the power of Bayesian inference and probabilistic programming, Varify will significantly reduce the uncertainty surrounding rare genetic variants and their impact on disease and treatment options. This breakthrough will enable healthcare professionals to deliver more precise diagnoses and personalized treatments, ultimately improving patient outcomes and revolutionizing the field of genomic medicine.

PI_NAMEs: SCHAFER, NICHOLAS  (contact)

PROGRAM_OFFICER_NAME: ZHANG, LI

PROJECT_TERMS: Address;American;Area;Automation;Automobile Driving;Bayesian Analysis;Benign;biobank;Biological Assay;Biological Sciences;BRAF gene;BRCA1 gene;BRCA2 gene;Breast Cancer Risk Factor;Cardiovascular Diseases;Caring;case control;Categories;CHEK2 gene;Classification;Clinical;Clinical Data;ClinVar;cohort;Complex;complex data;computational platform;Consumption;cost;Data;data integration;Data Set;Decision Making;Development;Diagnosis;Diagnostic;Disease;DNA sequencing;Early Diagnosis;experimental study;Foundations;Genes;genetic testing;genetic variant;Genomic medicine;Germ-Line Mutation;Guidelines;Health Professional;Hour;Human;human disease;improved;innovation;Innovation Corps;insight;Interview;KRAS2 gene;Laboratories;Learning;Malignant Breast Neoplasm;Malignant Neoplasms;Manuals;Marketing;Medical;Medical Genetics;medical schools;Methods;Modeling;molecular pathology;MSH2 gene;multiplex assay;Nerve Degeneration;Oncogenes;Outcome;Pathogenicity;Patient-Focused Outcomes;Patients;Performance;personalized medicine;Phase;Physicians;Population;Precision therapeutics;Process;programs;Proliferating;prospective;prototype;PTEN gene;Publications;Reporting;risk variant;Scientist;STK11 gene;Technology;text searching;Time;TP53 gene;Translating;treatment planning;Tumor Suppressor Proteins;Uncertainty;United States National Institutes of Health;Validation;Variant;variant of unknown significance;web app;Work

PROJECT_TITLE: Platform to support clinical variant interpretation through probabilistic assessment of functional evidence

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-B (14)]


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;Prevention

PHR: PROJECT NARRATIVE Genetic testing holds great promise for early assessment of risk for Alzheimer’s disease (AD) and AD-related dementias (ADRD), empowering patients and clinicians to make informed decisions about screening, treatment, and long-term care. Nevertheless, the clinical impact of testing is limited by the challenge of interpreting rare genetic variants, which are collectively common in the population and account for the majority of genetic AD/ADRD risk. Constantiam Biosciences is developing MAVEvidence, an application that leverages Multiplexed Assays of Variant Effect (MAVEs) as functional evidence to interpret gene variants in AD/ADRD risk genes, enabling clinical geneticists to access curated, analyzed, and validated MAVE data and to assess a patient’s personalized risk of disease.

PROGRAM_OFFICER_NAME: YAO, ALISON Q

PROJECT_TERMS: Address;Adoption;Age;alpha synuclein;Alzheimer's Disease;Alzheimer's disease model;Alzheimer's disease related dementia;Alzheimer's disease risk;Alzheimer's disease test;American;Amyloid Beta A4 Precursor Protein;apolipoprotein E-4;Area;autosome;Bayesian Method;Bayesian Modeling;Benign;biobank;Biological Assay;Biological Sciences;Brain Diseases;Businesses;Calibration;cancer classification;Cardiovascular Diseases;Cardiovascular system;Cause of Death;Classification;Clinic;Clinical;ClinVar;Code;cohort;Complex;complex data;Data;Data Set;dementia risk;detection method;Development;Diagnostic;Disease;disorder risk;empowerment;experimental study;familial Alzheimer disease;Family;Generations;Genes;Genetic;Genetic Risk;genetic testing;genetic variant;Genotype;Goals;Heritability;high risk population;improved;Incidence;indexing;Individual;Inherited;innovation;Investigational Therapies;Laboratories;Lewy Body Dementia;Long-Term Care;Malignant Neoplasms;Measures;Medical;Medical Genetics;medical schools;Modeling;molecular pathology;multiplex assay;Nervous System Trauma;Neurobehavioral Manifestations;Neurologic;Pathogenicity;Patients;Penetrance;personalized management;Phase;Physicians;Population;presenilin-1;prevent;Proteins;Publishing;rare variant;Risk;Risk Assessment;Risk Estimate;risk stratification;risk variant;Scientist;screening;segregation;Small Business Innovation Research Grant;SNCA gene;Source;Statistical Data Interpretation;stem;Symptoms;Testing;tool;Training;Translating;Translations;TREM2 gene;United States;Validation;Variant;variant of unknown significance;Work

PROJECT_TITLE: Leveraging high-throughput functional data for assessment of Alzheimer's risk


ADMINISTERING_IC: VA

IC_NAME: Veterans Affairs

ORG_NAME: VA EASTERN COLORADO HEALTH CARE SYSTEM

PHR: Lung adenocarcinoma (LUAD), a tobacco-related malignancy, also occurs in never smokers and is over- represented in veterans. Application of precision oncology with tyrosine kinase inhibitors (TKIs) in patients whose tumors bear oncogenic EGFR, ALK, ROS1 and RET yields frequent tumor shrinkage, but with wide variation in the treatment duration. Importantly, acquired drug resistance drives almost universal treatment failure. We propose that the therapeutic responses to TKIs involves induction of tumor-derived signals that instruct participation of both anti- and pro-tumorigenic immune cells. This project uses novel murine models of EGFR, ALK and RET-driven LUAD to identify tumor-derived signals and host immune cells that contribute to the TKI response. Also, pretreatment tumor specimens from patients will be analyzed for specific immune cells that predict the duration of response. Completion of the project may inform mechanisms regulating varied duration of patient benefit and potentially, novel vulnerabilities to increase duration of patient benefit from TKIs in LUAD.

PI_NAMEs: HEASLEY, LYNN E (contact)

PROJECT_TERMS: acquired drug resistance;adaptive immunity;anti-cancer;Biopsy;Biopsy Specimen;Blood specimen;burden of illness;cancer cell;Cancer Patient;cancer therapy;CD8-Positive T-Lymphocytes;cell type;Cells;chemokine;Chimeric Proteins;Clinical;clinical predictors;CXCL1 gene;CXCL9 gene;Data;drug action;Drug Targeting;Epidermal Growth Factor Receptor;Equilibrium;Exhibits;Genetic;Genetic Transcription;Growth Inhibitors;Heterogeneity;Immune;Immunity;Immunocompetent;immunodeficiency;Immunofluorescence Immunologic;Immunologics;Immunotherapy;In Vitro;inhibitor therapy;innovation;Interferon Type II;Knock-out;Knowledge;liquid crystal polymer;Literature;Lung Adenocarcinoma;lung cancer cell;Lung Neoplasms;Lymphocyte;Macrophage;Malignant neoplasm of lung;Malignant Neoplasms;Mediator;Modeling;Molecular;monocyte;mouse model;Mus;mutant;Mutation;Myeloid Cells;neoplastic cell;neutrophil;never smoker;novel;Oncogenes;Oncogenic;overexpression;Pathway interactions;Patients;PD-1 inhibitors;PDL1 inhibitors;peripheral blood;pharmacologic;Population;precision oncology;programmed cell death ligand 1;programs;Progression-Free Survivals;Publishing;Receptor Protein-Tyrosine Kinases;recruit;Reporting;Residual Neoplasm;response;Role;ROS1 gene;Signal Transduction;single-cell RNA sequencing;Specimen;Stains;System;T-Lymphocyte;targeted treatment;Testing;Therapeutic;Time;Tobacco;treatment duration;Treatment Failure;treatment response;tumor;tumor microenvironment;Tumor-Derived;tumor-immune system interactions;tumorigenic;Tyrosine Kinase Inhibitor;Variant;Veterans

PROJECT_TITLE: Role of Adaptive Immunity in Lung Cancer Response to Oncogene-targeted Therapeutics

STUDY_SECTION_NAME: Special Emphasis Panel[ZRD1 ONCB-A (01)]


NIH_SPENDING_CATS: Aging;Biotechnology;Brain Disorders;Gene Therapy;Genetics;Neurodegenerative;Neurosciences;Parkinson's Disease

ORG_CITY: SAN DIEGO

ORG_NAME: MARK THERAPEUTICS, INC.

PHR: Program Director/Principal Investigator (Last, First, Middle): Bolotina, Victoria Project Narrative: Currently, there is no cure and no therapy that can halt progression of devastating Parkinson’s disease. Mark Therapeutics proposes SBIR Phase 1 preclinical studies of the new candidates for a first-in-class gene therapy that can stop pathological loss of dopaminergic neurons and significantly slow down progression of disease in idiopathic Parkinson’s patients. This project aligns with NINDS objectives and addresses the unmet medical needs of the largest group of Parkinson’s patients. PHS 398/2590 (Rev. 11/07) Page Continuation Format Page

PI_NAMEs: BOLOTINA, VICTORIA M (contact)

PROGRAM_OFFICER_NAME: GILCHRIST, FLOY ANNETTE

PROJECT_TERMS: Achievement;Address;Affect;Aging;Animal Model;Animals;Biological;Boston;Businesses;Cell Line;Cell Physiology;Cells;commercialization;comparative;Compensation;Data;Dependence;design;Development;Development Plans;Diagnosis;Disease;Disease Progression;DNA Sequence Alteration;dopaminergic neuron;Dose;effective therapy;Ensure;Epigenetic Process;Etiology;experience;Family;Family history of;Feasibility Studies;fighting;Foundations;Funding;gene therapy;Genetic;Goals;Grant;Human;human disease;Idiopathic Parkinson Disease;improved;In Vitro;in vivo;individualized medicine;innovation;Intellectual Property;Interdisciplinary Study;invention;Knowledge;Lead;Leadership;Legal patent;Licensing;Medical;Mission;Modification;motor disorder;mouse model;National Institute of Neurological Disorders and Stroke;Nerve Degeneration;Neurons;new technology;novel;originality;Outcome;Parkinson Disease;Pathologic;Patients;Phase;Play;pre-clinical;preclinical study;Principal Investigator;Production;programs;Proteins;Qualifying;Recording of previous events;Research;Research Personnel;Risk;Role;Safety;Scientific Advances and Accomplishments;Secure;Signal Transduction;Small Business Innovation Research Grant;Solid;Substantia nigra structure;Testing;Therapeutic;therapeutic candidate;Therapeutic Uses;therapy development;Trademark;Treatment Efficacy;treatment optimization;United States National Institutes of Health;Universities;Validation;Viral;Viral Genes;Viral Packaging

PROJECT_TITLE: Gene Therapy for Idiopathic Parkinson's Disease

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 NV-H (13)]


NIH_SPENDING_CATS: Autoimmune Disease;Cancer;Colorectal Cancer;Digestive Diseases;Inflammatory Bowel Disease;Prevention

ORG_CITY: DOYLESTOWN

ORG_NAME: NOUS BIOSCIENCES INC

PHR: Narrative Colon cancer is the leading cause of cancer-associated mortality worldwide. One of the major causes of colon cancer is the disruption of epithelial cell homeostasis due to near loss of endogenous GC-C agonist expression. Thus, dolcanatide either alone or in combination with sildenafil offers a promising approach to normalize GC-C signaling for prevention of CRC.

PI_NAMEs: SHAILUBHAI, KUNWAR  (contact)

PROGRAM_OFFICER_NAME: BOZZA, WILLIAM PATRICK

PROJECT_TERMS: absorption;Acute;Adenocarcinoma;Agonist;analog;Animal Model;animal tissue;Animals;Applications Grants;atrial natriuretic factor receptor A;Azoxymethane;Binding;Biological Assay;Bypass;cancer diagnosis;Cancer Etiology;Cell Line;Charcoal;Chronic;Clinical;Clinical Data;clinical development;Colitis;Colitis associated colorectal cancer;Colon;Colon Adenocarcinoma;colon carcinogenesis;Colon Carcinoma;Colonic Neoplasms;Colonic Polyps;Colorectal Cancer;colorectal cancer prevention;Constipation;Cyclic GMP;Defecation;Development;Dietary Supplementation;Disease;Distal;Dose;Drug Formulations;Ensure;enterotoxin receptor;Enzymes;Epithelial Cells;Epithelium;Evaluation;Experimental Models;Female;Fluids and Secretions;Formulation;Gastric Bypass;Generations;Grant;Guanylate Cyclase;guanylin;High Pressure Liquid Chromatography;high risk;Homeostasis;Human;improved;In Vitro;Individual;Inflammation;Inflammatory;Inflammatory Bowel Diseases;inhibitor;intestinal barrier;intestinal epithelium;Intestinal permeability;Intestines;Irritable Bowel Syndrome;Knockout Mice;Ligands;Maintenance;male;meter;Microspheres;mortality;Mucous Membrane;murine colitis;Mus;Newly Diagnosed;novel;novel strategies;Oral;Oral Administration;Outcome;overexpression;particle;Particle Size;Peptides;Pharmaceutical Preparations;Phase;Phosphodiesterase Inhibitors;phosphodiesterase V;Placebos;Play;Polymers;Polyps;pre-clinical;preclinical study;Predisposition;Preparation;prevent;Prevention;Preventive;Production;receptor;Regulation;Research;Research Personnel;Role;Shapes;Signal Transduction;sildenafil;Small Business Innovation Research Grant;Therapeutic Effect;Thick;Time;Tissues;Transcript;treatment effect;treatment response;tumor;United States;uroguanylin

PROJECT_TITLE: Microsphere-based formulation of dolcanatide to prevent colon carcinogenesis

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CDPT-R (12)]


ADMINISTERING_IC: GM

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

ORG_CITY: ATLANTA

ORG_NAME: CHEMBIND LLC

ORG_STATE: GA

PHR: Project Narrative Sulfated O-GalNAc glycans play an important role in human health and disease. Yet, understanding their functions has been limited due to the absence of a comprehensive library of these glycans. We aim to create a library of them using our unique SMSEA method and produce the first sulfated O-GalNAc glycan microarray. This will enable the study of new interactions between biomolecules and sulfated O-GalNAc glycans, helping us delve deeper into their roles in biology.

PI_NAMEs: LIU, YUNPENG  (contact);ZHANG, JIAN

PROGRAM_OFFICER_NAME: ASLAN, KADIR

PROJECT_TITLE: SMSEA Approach to Synthesize Sulfated O-GalNAc Glycans for Functional Glycomics


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Emerging Infectious Diseases;Infectious Diseases;Prevention;Sexually Transmitted Infections

ORG_CITY: DURHAM

ORG_NAME: AIMMAX THERAPEUTICS, INC.

PHR: Project Narrative Antibiotic resistance in Neisseria gonorrhoeae is an urgent public health crisis requiring immediate action towards identifying new therapies without cross-resistance to existing antibiotics. Effective single dose therapies result in a faster resolution of symptoms and can significantly reduce the risk of spread of the infection in the community. We are developing a single-dose regimen of the novel antibiotic, AMX-2005, to rapidly treat drug-resistant gonorrhea.

PI_NAMEs: WANG, LAURENE  (contact)

PROGRAM_OFFICER_NAME: CONNOLLY, KRISTIE LEE

PROJECT_TERMS: absorption;Address;Advocate;Animals;Antibiotic Resistance;Antibiotic Therapy;Antibiotics;antimicrobial;Atopobium vaginae;azithromycin resistance;bactericide;Biological;Biological Assay;Blindness;Blood;Canis familiaris;Cardiovascular system;Ceftriaxone;Central Nervous System;Cephalosporins;Clinical Trials;Communities;Data;Development;Dose;Drug Interactions;Drug Kinetics;drug-resistant gonorrhea;Ectopic Pregnancy;Evaluation;Excretory function;Exhibits;Exposure to;extensive drug resistance;extracellular;Fiber;Fluoroquinolones;Formulation;Frequencies;genotoxicity;Goals;Gonorrhea;Grant;gut microbiota;health organization;Hour;Human;In Vitro;in vivo;Infection;Infertility;Injectable;innovation;Intramuscular;Intramuscular Injections;Lead;Left;Life;Macrolides;manufacture;Measures;Metabolism;Modeling;Mothers;mouse model;Mus;mutant;Mutation;Neisseria gonorrhoeae;neonate;Neurologic;Newborn Infant;No-Observed-Adverse-Effect Level;novel;novel antibiotic class;novel therapeutics;Oral;outbreak concern;Outpatients;Patient Compliance;Patients;Penicillins;Persons;Pharmaceutical Preparations;Pharmacology;Phase;Physicians;Plasma;pre-Investigational New Drug meeting;Prevention;Property;Public Health;Radiolabeled;Rattus;Recommendation;Recording of previous events;Regimen;Reporting;Resistance;Resistance development;resistant strain;Resolution;respiratory;Risk Reduction;Rodent;Route;Safety;safety assessment;Sepsis;Serial Passage;Series;Sexually Transmitted Diseases;Small Business Innovation Research Grant;Streptogramins;Sulfonamides;Symptoms;Tetracyclines;Therapeutic;Time;Toxic effect;Toxicology;transmission process;treatment guidelines;Vagina;Vertical Transmission;Woman;World Health Organization

PROJECT_TITLE: A Single Dose Therapy to Treat Drug Resistant Gonorrhea

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 DCAI-F (12)]