NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Cancer;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD)

ORG_DEPT: BIOMEDICAL ENGINEERING

PHR: Project Narrative The rapid histopathological examination can allow for an accurate intraoperative diagnosis and confirm negative tumor margins in the resected tissue (i.e., suggesting all of the cancer has been removed), providing surgical guidance and avoiding second surgeries. Currently, the intraoperative diagnosis in clinical practices relies mostly on the frozen section technique, which usually suffers from compromised diagnostic interpretation due to processing artifacts and only applies to limited tissue types. To address these challenges, I propose developing the deep learning-assisted photoacoustic histology platform to generate readily interpretable computer-aided images for pathologists and surgeons to diagnose intraoperatively and remotely.

PI_NAMEs: CAO, RUI  (contact)

PROGRAM_OFFICER_NAME: KING, RANDY LEE

PROJECT_TERMS: 3-Dimensional;absorption;Address;Algorithms;animal imaging;Animal Organ;bone;bone imaging;Cancer Patient;cancer surgery;cancer therapy;Cancerous;Cell Nucleus;cellular imaging;Cessation of life;Classification;Clinic;Clinical;clinical practice;commercialization;Computer Assisted;Computer-Assisted Diagnosis;convolutional neural network;cost;Cytoplasmic Protein;deep learning;deep neural network;design;Detection;Development;Diagnosis;Diagnostic;DNA;Dyes;Elements;Ensure;Equipment;Evolution;Excision;Freezing;Frozen Sections;Future;Hematoxylin and Eosin Staining Method;Histology;histopathological examination;Hospitals;Human;Human Resources;Image;image reconstruction;Image-Guided Surgery;Imaging Techniques;improved;Label;Lasers;Lesion;Lighting;Maintenance;Malignant Neoplasms;Masks;meter;Methods;microscopic imaging;Microscopy;Morphologic artifacts;neural network;Oncology;Operative Surgical Procedures;Optics;Pathologic;Pathologist;Pathology;Patient-Focused Outcomes;Patients;Pattern Recognition;Phase;photoacoustic imaging;Preparation;Publishing;Pulse Rates;Recurrent tumor;Research Proposals;Resected;Resolution;RNA;Sampling;Scanning;Sectioning technique;Series;Signal Transduction;Slide;Specimen;Speed;Stains;Structure;Subcellular structure;Surface;Surgeon;Surgical Oncology;Surgical wound;System;Techniques;Thick;Time;tissue processing;Tissues;tool;Training;Transducers;Translations;tumor;ultraviolet;Ultraviolet Rays;virtual

PROJECT_TITLE: Deep-learning assisted photoacoustic histology for real-time intraoperative pathological diagnosis


ADMINISTERING_IC: AT

ARRA_FUNDED: N

ED_INST_TYPE: SCHOOLS OF MEDICINE

FUNDING_MECHANISM: OTHER RESEARCH-RELATED

IC_NAME: NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH

NIH_SPENDING_CATS: Behavioral and Social Science;Chronic Pain;Complementary and Integrative Health;Hematology;Pain Research;Rare Diseases;Sickle Cell Disease

ORG_CITY: IRVINE

ORG_COUNTRY: UNITED STATES

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_FIPS: US

ORG_NAME: UNIVERSITY OF CALIFORNIA-IRVINE

ORG_STATE: CA

PHR: PROJECT NARRATIVE Music-based interventions (MBIs) including music therapy (MT) are known to be effective for managing pain in several populations, but substantial gaps remain in understanding the mechanisms of action by which MBIs influence pain. This proposal seeks to establish a NEW network: Effective Network to advance Scientific Evidence related to Mechanisms of music-Based interventions for pain and support coLlaborative Efforts (ENSEMBLE). ENSEMBLE will be instrumental in 1) promoting meaningful interdisciplinary dialogue; 2) building multi-institutional capacity for initiating MBI research in pain management; 3) generating preliminary data for future R21 or R34 grant proposals; 4) improving data infrastructure; 5) developing future MT clinician researchers; 6) focusing future scientific efforts; and 7) disseminating best practices.

PI_NAMEs: BHASIN, MANOJ ;DUSEK, JEFFERY A (contact);LOEWY, JOANNE V.;MALIK, SHAISTA

PROGRAM_OFFICER_NAME: CHEN, WEN G

PROJECT_TERMS: Address;Adult;advocacy organizations;Affect;Anxiety;Applications Grants;Area;Biological;Biological Markers;Board Certification;California;care seeking;Caring;chronic pain patient;Clinical;Clinical Research;clinically relevant;Cognitive;Collaborations;Complex;cost;Credentialing;Data;Data Collection;data de-identification;data infrastructure;data mining;Data Set;disability;Employment;Foundations;Fright;functional disability;Funding;Future;Gene Expression;Genomics;Goals;Health Professional;Healthcare;heart rate variability;Imagery;improved;Individual;Infrastructure;institutional capacity;instrument;Integrative Medicine;interdisciplinary collaboration;interest;Intervention;Intervention Studies;Learning Skill;Life;Malignant Neoplasms;Measures;Medical;medical schools;Medicine;meetings;member;Mental Depression;Meta-Analysis;metabolomics;Music;Music Therapy;neuroimaging;Neurologic;new technology;novel;Outcome Measure;Pain;Pain intensity;Pain interference;Pain management;pain reduction;Palliative Care;Patient advocacy;Patient Outcomes Assessments;Patients;Pharmaceutical Preparations;Phenotype;Pilot Projects;Population;practice-based research network;Process;Productivity;Public Health;Quality of life;Relaxation;Research;Research Personnel;Resources;Science;Scientific Advances and Accomplishments;Scientist;Sickle Cell Anemia;social;Therapeutic;tool;Training Programs;United States;Universities;University Hospitals

PROJECT_TITLE: Effective Network to advance Scientific Evidence related to Mechanisms of music-Based interventions (ENSEMBLE)


ADMINISTERING_IC: AR

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Patient Safety;Pediatric;Physical Activity;Prevention

ORG_CITY: DURHAM

ORG_NAME: DUKE UNIVERSITY

ORG_STATE: NC

PI_NAMEs: HOUMARD, JOSEPH A;KRAUS, WILLIAM E (contact)

PROGRAM_OFFICER_NAME: CARIFI, EMILY FORAN

PROJECT_TERMS: 17 year old;18 year old;Acute;Adipose tissue;Adult;Age;age group;Age Years;Ancillary Study;Animals;Attention;Award;Bioinformatics;Biological Process;Blood;California;Categories;Charge;Chemicals;Child;Childhood;Chronic;Clinical;clinical center;Clinical Protocols;Clinical Research;Clinical Trials Data Monitoring Committees;cohort;Collaborations;Collection;Communication;Communities;COVID-19;COVID-19 pandemic;Data;design;Development;Disease Outcome;disorder risk;endurance exercise;Enrollment;Ensure;ethnic minority;Exercise;exercise intervention;exercise training;falls;follow-up;Frequencies;Funding;Gender;Goals;Health;Health Benefit;Heterogeneity;Human;improved;Individual;innovation;insight;Institutional Review Boards;Intervention;Manuals;Manuscripts;Measurement;men;Minority Groups;Molecular;Multi-site clinical study;multiple omics;Muscle;novel;Observational Study;operation;pandemic disease;Participant;Pathway interactions;Pediatric cohort;Phase;Phenotype;phenotypic data;Physical activity;Physiological;pre-clinical;Procedures;Protocols documentation;public database;quality assurance;Race;racial minority;Randomized;Randomized, Controlled Trials;recruit;Recruitment Activity;Research;Research Personnel;Resistance;resistance exercise;Resources;response;Rest;sedentary;sex;Site;Suspensions;Testing;Time;Tissues;Training;Training Programs;Transducers;United States National Institutes of Health;Universities;Visit;Woman;working group;Youth

PROJECT_TITLE: MoTrPAC CPET Core Lab

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


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Cancer;Chronic Pain;Clinical Research;Diabetes;Digestive Diseases;Pain Research;Pancreatic Cancer;Rare Diseases

ORG_CITY: INDIANAPOLIS

ORG_NAME: INDIANA UNIVERSITY INDIANAPOLIS

ORG_STATE: IN

PHR: Chronic pancreatitis (CP) is a progressive, unrelenting disease, often leading to loss of exocrine and endocrine function and debilitating abdominal pain, resulting in significant healthcare costs. The Consortium for the study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer (CPDPC), now entering the final year of its second five- year funding cycle, has undertaken comprehensive clinical, epidemiological, and biological characterization of patients with CP (including adults and children with acute recurrent pancreatitis) to develop treatments and gain insight into the pathophysiology of CP and its sequela: chronic pain, pancreatic exocrine and endocrine insufficiency, and the diabetes/pancreatic cancer association. The Indiana University clinical center pledges to continue its contribution to ongoing high-priority CPDPC studies, which are described herein.

PI_NAMEs: FOGEL, EVAN L (contact)

PROGRAM_OFFICER_NAME: UNALP-ARIDA, AYNUR

PROJECT_TERMS: Abdominal Pain;Acute;Administrative Supplement;Adult;Biological;biomedical referral center;blood glucose regulation;candidate marker;Child;Childhood;chronic pain;chronic pancreatitis;Clinical;clinical center;Clinical Research;design;Diabetes Mellitus;Disease;Disease Progression;early onset;Endocrine;Enrollment;Epidemiology;Exocrine pancreas;experience;Functional disorder;Funding;genetic variant;Goals;Health Care Costs;Hormonal;Indiana;Individual;insight;Longitudinal Studies;Malignant neoplasm of pancreas;member;Metabolic;Non-Insulin-Dependent Diabetes Mellitus;Onset of illness;Patients;Population;profiles in patients;Progressive Disease;recruit;Research Personnel;Resources;response;Risk;Risk Factors;Secondary to;Testing;Universities;Work

PROJECT_TITLE: Indiana University (IU) Clinical Center for Chronic Pancreatitis Clinical Research Network


ADMINISTERING_IC: AG

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Behavioral and Social Science;Brain Disorders;Caregiving Research;Clinical Research;Clinical Trials and Supportive Activities;Complementary and Integrative Health;Dementia;Depression;Mental Health;Mental Illness;Neurodegenerative;Neurosciences;Palliative Care;Prevention

ORG_CITY: Campbell

ORG_NAME: PHOTOZIG, INC.

PHR: Public Health Relevance As a large number of informal family caregivers (over 11 million) are at high risk for stress and depressive symptoms related to the difficulties of caring for individuals with Alzheimer's Disease (AD), there is a need for effective, accessible and cost-effective interventions. The new Recharge Behavioral Therapy (delivered by the Recharge Mobile App, RMA) will be an innovative program for teaching Behavioral Activation skills to AD caregivers, motivating healthy behaviors, and improving psychological well-being, which can be deployed widely and at low cost. After Phase II completion, the expected project outcomes are: reduce stress, alleviate depressive symptoms, enhance coping skills, and improve the quality of life of AD caregivers; in addition, the following indirect benefits are expected (not measured by this study): delay patient institutionalization, decrease caregiver medication related to stress/depressive symptoms, and thereby lower economic costs associated with AD caregiving.

PI_NAMEs: KAJIYAMA, BRUNO  (contact)

PROGRAM_OFFICER_NAME: HARRELL, ERIN

PROJECT_TERMS: Address;Alzheimer's Disease;Alzheimer's disease caregiver;Alzheimer's disease patient;American;Anxiety;Apple;Behavior;Behavior Therapy;Behavioral;Calendar;care burden;care systems;caregiver stress;Caregivers;caregiving;Caring;Charge;chronic pain;Clinical Trials;Cognitive;Complement;coping;Coping Skills;cost;cost effective intervention;Creativeness;Data;Dementia;Dementia caregivers;dementia caregiving;depressive symptoms;design;Development;Distress;economic cost;Educational Curriculum;Educational process of instructing;effective therapy;Effectiveness;Effectiveness of Interventions;Emotional;Emotions;Environment;Evaluation;Event;evidence base;Family;Family Caregiver;Family member;feasibility testing;Fees;flexibility;Focus Groups;Fostering;Goals;Health;high risk;Home;Hybrids;improved;Incidence;Individual;informal care;innovation;Institutionalization;Intervention;Learning;Link;Literature;Location;Marketing;Mental Depression;Methods;mindfulness;mindfulness intervention;mobile application;Moods;Music;Nonpharmacologic Therapy;Notification;Outcome;Patients;Personal Satisfaction;Personality;Persons;Pharmaceutical Preparations;Phase;Play;prevent;programs;Protocols documentation;prototype;psychoeducation;public health relevance;Publishing;Quality of life;Randomized;randomized, clinical trials;recruit;recurrent depression;relapse prevention;Reporting;Research;Rewards;Role;Services;skills;social;Stress;stress management;stress reduction;stress symptom;Symptoms;Testing;Therapeutic Intervention;Time;Training;Training Programs;Translating;usability;Well in self

PROJECT_TITLE: Recharge Behavioral Therapy for caregivers of individuals with Alzheimer's Disease

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-BP-C(10)B]


ADMINISTERING_IC: HG

IC_NAME: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

NIH_SPENDING_CATS: Biotechnology;Clinical Research;Clinical Trials and Supportive Activities;Cost Effectiveness Research;Dissemination and Implementation Research;Genetics;Human Genome

PHR: Project Narrative The purpose of this project is to provide efficient and effective implementation of the chosen pragmatic clinical trials and coordination of the IGNITE Network and to facilitate dissemination and communication with relevant communities outside the network. The success of this proposal will help facilitate knowledge translation from the genomic demonstration projects into the research and clinical communities thereby accelerating the translation of proven tools into real world settings.

PI_NAMEs: CHAKRABORTY, HRISHIKESH ;WYATT, CHRISTINA M (contact)

PROGRAM_OFFICER_NAME: RIDER, RENEE ANNE

PROJECT_TERMS: Acceleration;Accountability;Address;Administrative Coordination;Amplifiers;Area;Case Report Form;catalyst;Clinical;clinical care;Clinical effectiveness;clinical practice;Clinical Research;Clinical Trials Data Monitoring Committees;Clinical Trials Design;Clinical Trials Network;ClinVar;Collaborations;Communication;Communities;Community Medicine;Consent;cost effective;Cost Effectiveness Analysis;Creativeness;dashboard;Data;Data Analyses;Data Collection;data interoperability;data management;Data Management Resources;data platform;data quality;Data Sources;data standards;database of Genotypes and Phenotypes;Databases;design;Discipline;Documentation;effective intervention;Effectiveness;electronic data capture system;Enrollment;Ensure;Environment;evidence base;experience;falls;flexibility;Fostering;genome sciences;genomic data;Genomic medicine;Genomics;Goals;implementation evaluation;implementation facilitation;implementation/effectiveness;improved;Information Technology;Infrastructure;innovation;insight;Institution;Institutional Review Boards;International;Intervention;Intranet;Knowledge;knowledge base;knowledge hub;knowledge translation;Leadership;leadership development;Learning;material transfer agreement;Measures;meetings;member;Monitor;novel;Office of Administrative Management;Online Systems;Ownership;Participant;Patient Recruitments;phenotypic data;Positioning Attribute;Pragmatic clinical trial;pragmatic implementation;precision medicine;Problem Solving;Productivity;programs;Protocols documentation;Publications;quality assurance;Quality Control;recruit;Reporting;Research;Research Institute;Resources;Risk;Sample Size;Standardization;Statistical Data Interpretation;Structure;success;synergism;Time;tool;Training;translational genomics;Translations;trial design;United States National Institutes of Health;Universities;uptake;Vision;Work;working group;Writing

PROJECT_TITLE: The IGNITE II CC:  Engagement, Coordination, Demonstration, and Dissemination


ADMINISTERING_IC: DC

IC_NAME: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

NIH_SPENDING_CATS: Clinical Research;Neurosciences

ORG_CITY: AUSTIN

ORG_DEPT: NEUROLOGY

ORG_NAME: UNIVERSITY OF TEXAS AT AUSTIN

ORG_STATE: TX

PHR: Project Narrative  This study will determine if neck-skin vibration sensor and head-mounted microphone signals can be used to identify the physiological sources of modulated voice and to track responses to voice treatment. It is expected that the study findings will advance clinical identification of the subsystems affected by tremor and facilitate evaluation of individualized, targeted treatments for speakers with VT.

PI_NAMEs: LESTER-SMITH, ROSEMARY ANNE (contact)

PROGRAM_OFFICER_NAME: KOPF, LISA MARIE

PROJECT_TERMS: Acoustics;Address;Adverse effects;Affect;Behavioral;botulinum neurotoxin injection;Clinical;Clinical assessments;clinical diagnosis;Clinical Treatment;Communication;Computer Models;cost;Essential Tremor;Evaluation;Frequencies;Head;Impairment;individualized medicine;Injections;kinematics;Larynx;Length;Loudness;machine learning model;Measures;Medical;Methods;microphone;Modeling;Movement Disorders;Neck;Neurologic Voice Disorder;Nose;Oropharyngeal;patient response;Patients;Pattern;Persons;Phase;Physiological;Plethysmography;Procedures;Production;Productivity;Quality of life;respiratory;Respiratory System;response;sensor;Signal Transduction;Skin;sound;Source;Speech;stem;Surface;Tactile;targeted treatment;Techniques;Testing;Therapeutic;Time;Training;treatment response;Tremor;vibration;Visual;vocal cord;Voice

PROJECT_TITLE: Differentiating the Physiological Sources of Modulated Voice

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


ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

NIH_SPENDING_CATS: Brain Cancer;Brain Disorders;Cancer;Immunotherapy;Neurosciences;Rare Diseases

ORG_CITY: ROCHESTER

ORG_NAME: MAYO CLINIC ROCHESTER

ORG_STATE: MN

PHR: PROJECT NARRATIVE The proposed studies will investigate the mechanisms that govern immune response to the brain tumor, glioblastoma. These mechanistic insights will help to inform the development of potential new combination therapeutic strategies for manipulating the specific immune cells, macrophages, in order to enhance anti-tumor immune response. This career development award will provide the applicant with high-level training and thereby allow her to launch an independent research career aimed at improving outcomes for patients suffering from brain tumors.

PI_NAMEs: HOFSTATTER AZAMBUJA, JULIANA  (contact)

PROGRAM_OFFICER_NAME: KOTLIAROVA, SVETLANA

PROJECT_TERMS: Affect;aggressive therapy;Agonist;antagonist;anti-tumor immune response;Award;BCL10 gene;Behavior;Biological Markers;Blood - brain barrier anatomy;Bone Marrow;Brain;Brain Neoplasms;C Type Lectin Receptors;career;career development;Cell Communication;Cells;chemotherapy;Clinic;Complex;Data;Development;Disease;Drug Delivery Systems;Educational Status;efficacy evaluation;Fostering;Foundations;Funding Mechanisms;Glioblastoma;Human;Immune;Immune response;Immunooncology;immunoreactivity;Immunosuppression;Immunotherapeutic agent;improved;improved outcome;In Vitro;in vivo;Individual;Infiltration;Inflammatory;innovation;insight;K-Series Research Career Programs;Lead;Libraries;Macrophage;Macrophage Activation;Malignant neoplasm of brain;Malignant Neoplasms;Mediating;Mediator;Medical;Mentors;Microglia;Molecular;Mucosa- associated lymphoid tissue lymphoma translocation protein-1;Mus;Myeloid Cells;Myeloproliferative disease;Nature;neoplastic cell;neuro-oncology;novel;novel strategies;novel therapeutic intervention;Operative Surgical Procedures;Organoids;Outcome;Pathogenesis;Patient-Focused Outcomes;Patients;Phase;Phenotype;Play;Postdoctoral Fellow;Primary Brain Neoplasms;Prognosis;programs;Proteomics;Radiation therapy;receptor;recruit;Research;Research Personnel;Resources;response;Role;Scaffolding Protein;Signal Transduction;Signaling Protein;Solid Neoplasm;Survival Rate;targeted treatment;Therapeutic;Therapeutic Effect;Therapeutic Intervention;therapeutic target;therapeutically effective;therapy resistant;training opportunity;Treatment outcome;Treatment Protocols;treatment response;treatment strategy;tumor;tumor growth;tumor heterogeneity;Tumor Immunity;tumor microenvironment;tumor progression;Tumor-associated macrophages;tumor-immune system interactions;tumorigenic;Universities;Work

PROJECT_TITLE: Harnessing Tumor Associated Macrophages in Glioblastoma

STUDY_SECTION: NST

STUDY_SECTION_NAME: NST-2 Study Section [NST-2]


ADMINISTERING_IC: CA

IC_NAME: NATIONAL CANCER INSTITUTE

ORG_CITY: WINSTON-SALEM

ORG_DEPT: BIOLOGY

ORG_NAME: WAKE FOREST UNIVERSITY HEALTH SCIENCES

PHR: PROJECT NARRATIVE Although colorectal cancer (CRC) is enriched with pathogenic mtDNA mutations, the role of the mitochondrion in CRC remains unknown. In this proposal, we will leverage our expertise in mitochondrial biochemistry, state- of-the art in vivo, in vitro, and ex vivo CRC models, and viral genetic manipulation to define the molecular pathways linking mitochondrial metabolism to CRC growth. By providing a mechanistic link between mitochondrial bioenergetics and CRC, this work will move the field forward in our understanding of the role of mitochondria in CRC, ultimately paving the way for CRC-specific mitochondrial interventions.

PI_NAMEs: FISHER-WELLMAN, KELSEY H (contact)

PROGRAM_OFFICER_NAME: WILLIS, KRISTINE AMALEE

PROJECT_TERMS: Acceleration;alternative oxidase;Anabolism;antiporter;Aspartate;ATP Synthesis Pathway;Biochemistry;Bioenergetics;burden of illness;cancer cell;cancer initiation;Cancer Model;catalase;Catalytic Domain;Cell Proliferation;Cell Respiration;Chemicals;Clinical;Colon;Colorectal Cancer;Complex;Cytochrome c Reductase;Cytosol;Data;Data Set;Electron Transport;Exhibits;experimental study;Exposure to;Gene Deletion;Generations;Genes;Genetic;genetic approach;genetic manipulation;Genetically Engineered Mouse;Glutamates;Goals;Growth;Homeostasis;Human;human model;Impairment;In Vitro;in vivo;Incidence;inhibitor;insight;Intervention;Knockout Mice;Large-Scale Sequencing;Link;loss of function;loss of function mutation;Malignant Neoplasms;Mediating;Metabolic;Mitochondria;Mitochondrial DNA;mitochondrial DNA mutation;mitochondrial metabolism;Molecular;mouse model;Mus;Mutate;NADH;Normal tissue morphology;Organoids;oxidation;Oxidation-Reduction;Pathogenesis;Pathogenicity;Pathway interactions;pharmacologic;Proteins;Proteome;Reactive Oxygen Species;Respiration;respiratory;Respiratory physiology;response;Role;Stress;Testing;Therapeutic;Tissues;transgene expression;tumor;tumor growth;Tumor-Derived;tumorigenesis;tumorigenic;virus genetics;Work;Xenograft procedure;Yeasts

PROJECT_TITLE: Mitochondrial bioenergetics and colorectal cancer

STUDY_SECTION: CCB

STUDY_SECTION_NAME: Cancer Cell Biology Study Section[CCB]


NIH_SPENDING_CATS: Autoimmune Disease;Clinical Research;Diabetes;Networking and Information Technology R&D (NITRD);Pediatric;Social Determinants of Health

ORG_CITY: TAMPA

ORG_NAME: UNIVERSITY OF SOUTH FLORIDA

ORG_STATE: FL

PHR: NARRATIVE Type 1 diabetes (T1D) is a complex, polygenic autoimmune disease that results from the immune destruction of insulin-producing cells. There is extensive heterogeneity in which AABs are expressed and at what levels, along with variations in donor/family information and Social Determinants of Health (SDoH), which significantly influence disease prognosis and outcomes. This project aims to define and harmonize common data elements to support interoperability and to enforce, and sustain the adoption and compliance of the developed CDE.

PI_NAMEs: KRISCHER, JEFFREY P (contact)

PROGRAM_OFFICER_NAME: CASTLE, ARTHUR

PROJECT_TERMS: Adoption;Autoimmune Diseases;case control;Cells;cohort;Collaborations;Common Data Element;Communities;Complex;Diabetes Mellitus;Disease Outcome;disease prognosis;Ensure;Family;follow-up;Heterogeneity;Immune mediated destruction;Insulin;Insulin-Dependent Diabetes Mellitus;interoperability;Non-Insulin-Dependent Diabetes Mellitus;Outcome;Publishing;repository;Research Design;Resources;Semantics;social health determinants;United States National Institutes of Health;Variant

PROJECT_TITLE: Limited Competition: Continued Follow-up of Subjects and Initiation of a Second Case-control Cohort in The Environmental Determinants of Diabetes in The Young Study (TEDDY)


NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Clinical Research;Mental Health;Social Determinants of Health;Urologic Diseases

ORG_CITY: CHICAGO

ORG_DEPT: OBSTETRICS & GYNECOLOGY

ORG_NAME: UNIVERSITY OF CHICAGO

ORG_STATE: IL

PHR: PROJECT NARRATIVE The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) was assembled in 2012 to increase the understanding of lower urinary tract symptoms (LUTS), which has included determining relationships between psychosocial variables and LUTS. In this supplement, we will focus on 1) Determining the relationship between level of cognitive function and LUTS and 2) Determining baseline predictors of LUTS trajectories in a sample of men and women with urinary urgency. We also plan to explore psychosocial variables that have not been explored with respect to urgency, such as intolerance of uncertainty, catastrophizing, and adverse childhood experiences, which will add to the understanding of phenotypes among patients with urinary urgency as a primary symptom.

PI_NAMEs: GRIFFITH, JAMES WILLIAM (contact);KENTON, KIMBERLY SUE

PROGRAM_OFFICER_NAME: MULLINS, CHRISTOPHER V

PROJECT_TERMS: Activities of Daily Living;Administrative Supplement;adverse childhood events;Age;Anxiety;biomarker signature;biopsychosocial;Bladder;Body mass index;Characteristics;Clinical;Clinical Trials;clinically relevant;Cognition;cognitive function;cohort;Communities;Data;Data Analyses;Data Collection;Dementia;Electronics;Functional disorder;Goals;Grant;Health;Impaired cognition;Impairment;improved;Individual;Internist;Lower urinary tract;lower urinary tract symptoms;Measurement;Measures;men;Mental Depression;Mental Health;micturition urgency;Modeling;Moods;National Institute of Diabetes and Digestive and Kidney Diseases;novel;Outcome;parent project;Parents;Participant;patient oriented;Patient Self-Report;Patients;Phenotype;Plasma;protein biomarkers;Psychosocial Factor;Questionnaires;Research;Research Personnel;response;Risk;Sampling;Self Administration;Self Assessment;Severities;Sleep disturbances;Stress;Subgroup;Symptoms;Testing;tool;U-Series Cooperative Agreements;Uncertainty;United States National Institutes of Health;Urethra;urinary;Urologist;web site;Woman;Work;Writing

PROJECT_TITLE: LURN II: Enhanced Characterization of Patients with LUTS Using Biopsychosocial Approaches


NIH_SPENDING_CATS: Cancer;Cancer Genomics;Clinical Research;Genetics;HIV/AIDS;Hematology;Human Genome;Infectious Diseases;Lymphatic Research;Lymphoma;Rare Diseases

ORG_CITY: MANHASSET

ORG_NAME: FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH

ORG_STATE: NY

PHR: PROJECT NARRATIVE Epstein-Barr Virus and Human Immunodeficiency Virus (HIV) modulate human endogenous retroviruses (HERVs) within the cell they infect. This grant investigates how these activities intersect and synergize to promote the development of lymphoma in people living with HIV, and how translated HERV products could create neoantigenic targets for immune attack in diffuse large B cell lymphoma (DLBCL).

PI_NAMEs: CESARMAN, ETHEL ;NIXON, DOUGLAS F (contact)

PROGRAM_OFFICER_NAME: LIDDELL HUPPI, REBECCA

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Affect;AIDS related cancer;AIDS-Related Diffuse Large B-cell Lymphoma;B-Cell Lymphomas;B-Lymphocytes;BCL2 gene;BCL6 gene;Binding;Biology;Brazil;CD4 Positive T Lymphocytes;Cell Line;Cell Proliferation;Cells;Clear cell renal cell carcinoma;Coculture Techniques;Common Neoplasm;Complex;computerized tools;Cytotoxic T-Lymphocytes;Data;Developed Countries;Development;Disease;DNA;DNA Transposable Elements;Elements;Endogenous Retroviruses;Enhancers;Environmental Risk Factor;Epitopes;Epstein-Barr Virus Infections;Evolution;exome;Family;Gene Expression;Genes;Genetic;Genomics;Germ Lines;Grant;HIV;HIV Infections;HIV Seronegativity;Human;Human Cloning;Human Genome;Human Herpesvirus 4;Immune Targeting;Immunology;Immunophenotyping;Immunotherapy;In Vitro;in vitro Model;Incidence;Individual;infected B cell;Infection;Junk DNA;K-18 conjugate;large cell Diffuse non-Hodgkin's lymphoma;Link;lymph nodes;Lymphoma;Lymphoma cell;Lymphomagenesis;Malignant Neoplasms;Mediating;Medicine;Molecular;Morphology;neoplastic cell;new therapeutic target;Nucleic Acids;Oncogenic;Pathogenesis;Pathologic;Patients;Pattern;peripheral blood;Persons;Physiological;Physiology;Play;Process;promoter;Prospective cohort;Proteins;Proto-Oncogenes;Regulation;Repression;response;Retrospective cohort;Retroviridae;ribosome profiling;Role;Sampling;single cell ATAC-seq;single cell genomics;single-cell RNA sequencing;Specialist;Standardization;synergism;System;T-Lymphocyte;T-Lymphocyte Epitopes;targeted treatment;Testing;Therapeutic Intervention;Tissues;Tonsil;transcriptome sequencing;transcriptomics;Translating;tumor;tumor microenvironment;tumor progression;Tumor Subtype;Tumor Suppressor Genes;tumorigenesis;United States;Untranslated RNA;Up-Regulation;Viral;Viral Genome;Viremia;Virus;Work

PROJECT_TITLE: Regulatory Crosstalk Between Human Endogenous Retroviruses, HIV, and EBV, in Lymphoma


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Behavioral and Social Science;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Cocaine;Comparative Effectiveness Research;Drug Abuse (NIDA only);Methamphetamine;Neurosciences;Opioid Misuse and Addiction;Opioids;Patient Safety;Stimulant Use and Misuse;Substance Misuse

ORG_CITY: DALLAS

ORG_DEPT: PSYCHIATRY

ORG_NAME: UT SOUTHWESTERN MEDICAL CENTER

PHR: Yr20 Supplement Request Narrative CTN-0109 Randomized, placebo-controlled trial of extended-release naltrexone and monthly extended-  release buprenorphine for cocaine use disorder (CURB-2) Currently there are no pharmaceutical treatments for cocaine use disorder (CUD). This study is an 8-week, double-blind, randomized placebo-controlled trial to determine the efficacy of a combination of extended- release naltrexone and extended-release buprenorphine compared to placebo injections for the treatment of CUD.  Yr20 Supplement Request Narrative CTN-0132 Randomized, Double-Blind, Active Placebo-Controlled Trial of Ketamine for  Methamphetamine Use Disorder (KMD) Currently there are no pharmaceutical treatments for methamphetamine use disorder (MUD). This study is a 12-week randomized, double-blind, controlled trial comparing intravenous (IV) ketamine against IV midazolam, delivered over six weeks in adults with moderate to severe methamphetamine use disorder (MUD).

PI_NAMEs: POTTER, JENNIFER SHARPE;SHOPTAW, STEVEN J;TRIVEDI, MADHUKAR H. (contact)

PROGRAM_OFFICER_NAME: DOBBINS, RONALD

PROJECT_TERMS: Acute;Adult;Adverse event;analog;Buprenorphine;Clinical Trials Network;Cocaine;cocaine craving;cocaine use;Cocaine use disorder;Double-Blind Method;Drug Screening;effectiveness evaluation;efficacy evaluation;Event;Infusion procedures;Injections;Intravenous;Ketamine;Measures;Methamphetamine use disorder;Midazolam;Naltrexone;National Institute of Drug Abuse;opioid use disorder;Outcome;Outcome Measure;Outpatients;Overdose;Patient Self-Report;Pharmacologic Substance;Phase;placebo controlled trial;Placebos;primary outcome;Randomized;randomized placebo controlled trial;Reporting;Safety;secondary outcome;Severities;Site;Treatment Effectiveness;trial comparing;Urine;Visual

PROJECT_TITLE: NIDA Clinical Trials Network: Big South/West Node Supplemental - CURB CTN0109 & KMD CTN0132


ADMINISTERING_IC: GM

ED_INST_TYPE: SCHOOLS OF VETERINARY MEDICINE

FUNDING_MECHANISM: RESEARCH CENTERS

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Biotechnology;Breast Cancer;Building Research Capacity at Institutions with Limited NIH Funding;Cancer;Women's Health Research

ORG_CITY: BATON ROUGE

ORG_DEPT: PATHOLOGY

ORG_NAME: LOUISIANA STATE UNIV A&M COL BATON ROUGE

ORG_STATE: LA

PI_NAMEs: VEGGIANI, GIANLUCA  (contact)

PROGRAM_OFFICER_NAME: PEI, WUHONG

PROJECT_TERMS: Address;Affinity;Affinity Chromatography;anti-cancer research;Binding;cancer drug resistance;chemotherapy;Chromatography;Communities;Development;drug development;Drug resistance;Engineering;FHA Domain;functional hypothalamic amenorrhea;Human;Immobilization;innovation;Malignant Breast Neoplasm;Mass Spectrum Analysis;Mediating;Metals;Neoplasm Metastasis;new therapeutic target;novel;novel marker;Patients;Peptides;phosphoproteomics;Phosphorylation;Phosphothreonine;Phosphotyrosine;pre-clinical;Prognosis;Protein Engineering;Proteins;Proteome;Resistance;Signal Pathway;Signal Transduction;src Homology Region 2 Domain;standard care;targeted treatment;Techniques;tool;treatment strategy;triple-negative invasive breast carcinoma;Work

PROJECT_TITLE: Revealing the hidden phosphoproteome of drug resistant triple negative breast cancer


ADMINISTERING_IC: DE

ED_INST_TYPE: SCHOOLS OF DENTISTRY/ORAL HYGN

IC_NAME: NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH

NIH_SPENDING_CATS: Cancer;Cancer Genomics;Dental, Oral, and Craniofacial Disease;Digestive Diseases;Genetics;Human Genome;Prevention;Rare Diseases

ORG_CITY: SAN FRANCISCO

ORG_DEPT: DENTISTRY

ORG_NAME: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

PHR: Protect Narrative The overall survival rate of oral cancer has only marginally improved in the last few decades due to its late diagnosis. This project aims to use a combination of gene expression, immune cell profiling, and clinical information to identify biomarkers to predict the development of oral cancer from pre-malignant oral lesions. By identifying these markers, it is possible to more accurately predict which premalignant lesions are at risk of progressing to cancer to provide guidance to clinicians for appropriate management with a concomitant reduction in oral cancer morbidity and mortality.

PI_NAMEs: MOMEN HERAVI, FATEMEH  (contact)

PROGRAM_OFFICER_NAME: WAN, JASON

PROJECT_TERMS: Address;Alcohols;biobank;Biological Markers;biomarker identification;Cancer Etiology;CD8-Positive T-Lymphocytes;Cells;Cessation of life;Characteristics;Clinical;clinical biomarkers;clinical decision-making;Code;cohort;Communities;conventional therapy;Data;Data Set;Development;Diagnosis;Disease;Early Diagnosis;Early identification;Etiology;Fluorescence;follow-up;Gene Combinations;Gene Expression;Heterogeneity;high risk;Histologic;Histopathologic Grade;HPV negative;HPV positive;HPV-High Risk;Human Papillomavirus;Immune;Immunologic Markers;Immunotherapy;improved;Incidence;Individual;Knowledge;Lesion;Leukoplakia;Machine Learning;Malignant - descriptor;Malignant Conversion;malignant mouth neoplasm;Malignant Neoplasms;malignant oropharynx neoplasm;Microscopic;Modality;Modeling;Molecular;Morbidity - disease rate;mortality;mouth squamous cell carcinoma;multidisciplinary;NCI-Designated Cancer Center;neoplastic;Oral;Oral Examination;oral lesion;Oral Leukoplakia;Oral Stage;Patients;Persons;Play;Population Heterogeneity;premalignant;Prevention;progression marker;racial diversity;recruit;response;Risk;Risk Assessment;risk prediction model;risk stratification;Role;screening;Specimen;survival outcome;Survival Rate;Tissues;Tobacco;Transcript;transcriptome sequencing;transcriptomics;Translations;tumor;Tumor-associated macrophages;tumor-immune system interactions;Universities;Untranslated RNA;Validation

PROJECT_TITLE: Immune and transcriptomic biomarkers of progressive oral premalignant lesions


FUNDING_MECHANISM: OTHERS

NIH_SPENDING_CATS: Behavioral and Social Science;Brain Disorders;Clinical Research;Drug Abuse (NIDA only);Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Mental Health;Opioid Misuse and Addiction;Opioids;Pain Research;Substance Misuse

ORG_CITY: HONOLULU

ORG_NAME: UNIVERSITY OF HAWAII AT MANOA

ORG_STATE: HI

PI_NAMEs: GOEBERT, DEBORAH A. (contact);ONOYE, JANE

PROGRAM_OFFICER_NAME: SMITH, JACLYN D'ANNE

PROJECT_TERMS: Acute Pain;addiction;Address;Belief;Caring;chronic pain;Clinical;clinical translation;Collaborations;Communities;community empowerment;community engagement;Community Outreach;Cultural Backgrounds;Cultural Sensitivity;cultural values;Data;Data Analyses;Data Collection;design;Development;Diagnosis;Disease;Disparity;Educational workshop;Ensure;Epidemic;Equitable healthcare;Ethnic Population;Evaluation;Family;Feedback;Fostering;Future;Future Generations;Generations;Grant;Hawaii;Hawaiian;Hawaiian population;healing;Health;health disparity;health equity promotion;Health Technology;Healthcare;Helping to End Addiction Long-term;improved;Indigenous;Individual;information gathering;innovation;Institution;Intervention;Investments;Island;Knowledge;Language;Lead;Literature;Measures;meetings;Mental disorders;Mental Health;Mental Health Services;Mentorship;Methodology;Methods;mHealth;Modeling;Monitor;Native Hawaiian;Opiate Addiction;opioid misuse;opioid use disorder;Outcome;Outcome Measure;Overdose;Pain;Pain management;Participant;Pathologic;Personal Satisfaction;Persons;Phase;Policies;Population;programs;promote resilience;Provider;psychologic;Publications;Recovery;relapse prevention;Reporting;Research;Research Activity;Research Methodology;Research Personnel;resilience;Resources;Safety;Secure;Services;Site;skills;social;Societies;socioeconomic disadvantage;Source;Speed;Spirituality;stimulant use disorder;Substance abuse problem;substance abuse treatment;substance use;Substance Use Disorder;System;Techniques;Thinking;Time;Training;transmission process;Treatment outcome;treatment program;treatment response;treatment services;United States National Institutes of Health;Universities;Use Effectiveness;Writing

PROJECT_TITLE: Hawaii N CREW Research Resource Center


NIH_SPENDING_CATS: Kidney Disease;Social Determinants of Health

ORG_CITY: NEW YORK

ORG_NAME: NEW YORK UNIVERSITY SCHOOL OF MEDICINE

PHR: Project Narrative: This K26 grant is for support of Dr. Michal L. Melamed in her mentoring of the next generation of Pediatric and Adult Kidney Health researchers. Dr. Melamed is an award- winning mentor with a long history of successfully mentoring individuals from Diverse Backgrounds. This award will allow her to devote more time to mentoring multiple trainees, including individuals from groups Underrepresented in Medicine, into academic careers in clinical research in Kidney Health.

PI_NAMEs: MELAMED, MICHAL L (contact)

PROGRAM_OFFICER_NAME: RANKIN, TRACY L

PROJECT_TERMS: Adult;Advisory Committees;Alkalies;American;Appointment;Area;Attention;Award;Biological Markers;Black race;bone;bone health;Cardiovascular Diseases;career;career development;Caring;Child;Childhood;Cities;Clinical;clinical epidemiology;Clinical Research;Clinical Trials;Collaborations;college;Congresses;Data;design;doctoral student;Educational workshop;Equity;ethnic minority;experience;Faculty;Fellowship;Fellowship Program;Funding;Grant;Health;health care delivery;health equity;Health equity research;Hematology;Hemodialysis;Home;Hospitals;improved;Individual;innovation;Institution;interest;Internal Medicine;International;Joints;Kidney;Kidney Diseases;Leadership;leadership development;Literature;Medical;Medical center;medical schools;Medical Students;Medicine;meetings;member;Mentored Clinical Scientist Development Program;Mentored Patient-Oriented Research Career Development Award;Mentors;Mentorship;Metabolic acidosis;Methods;Modeling;National Institute of Diabetes and Digestive and Kidney Diseases;Nephrology;New York;next generation;novel;Paper;Pathway interactions;patient population;Patients;peer coaching;Peripheral;Personal Satisfaction;Positioning Attribute;Postdoctoral Fellow;potassium citrate;pre-doctoral;programs;Publishing;Qualifying;racial minority population;randomized placebo controlled trial;randomized, clinical trials;Recommendation;Recording of previous events;recruit;Renaissance;Reporting;Research;Research Personnel;Research Training;Resolution;responsible research conduct;Role;Science;secondary analysis;skills;social health determinants;Societies;Sodium Bicarbonate;Spottings;Students;symposium;Time;TNFSF15 gene;Training;undergraduate student;Underrepresented Populations;United States National Institutes of Health;Universities;urologic;Vascular calcification;Woman;women faculty;Work;Writing;X-Ray Computed Tomography

PROJECT_TITLE: Mentoring in Kidney Health to Improve Equity


ADMINISTERING_IC: CK

IC_NAME: National Center for Emerging and Zoonotic Infectious Diseases

ORG_CITY: IOWA CITY

ORG_NAME: UNIVERSITY OF IOWA

ORG_STATE: IA

PI_NAMEs: HERWALDT, LOREEN A (contact)

PROJECT_TITLE: RFA-CK20-004: Infection Prevention and Antimicrobial Stewardship: Minding the Gaps: The Iowa Prevention Epicenter


ORG_CITY: BALTIMORE

ORG_NAME: UNIVERSITY OF MARYLAND BALTIMORE

ORG_STATE: MD

PI_NAMEs: HARRIS, ANTHONY D (contact)

PROJECT_TITLE: RFA-CK20-004: Prevention Epicenters Program: Protecting Patients from Infections, Antibiotic Resistance andOther Adverse Events


ORG_NAME: JOHNS HOPKINS UNIVERSITY

PI_NAMEs: COSGROVE, SARA ELIZABETH (contact);ROCK, CLARE

PROJECT_TITLE: RFA-CK20-004: Johns Hopkins Prevention Epicenter: Transdisciplinary Research Approaches to Prevent Healthcare Associated Infections and Antibiotic Resistance (TRAP HAI & AR)


ADMINISTERING_IC: VA

IC_NAME: Veterans Affairs

ORG_CITY: ANN ARBOR

ORG_NAME: VETERANS HEALTH ADMINISTRATION

ORG_STATE: MI

PHR: Hazardous drinking is a large and growing problem for Veterans across age groups. Many Veterans with hazardous drinking and other mental health problems seek care in the Emergency Department (ED). This study is a randomized controlled trial (N=450) of an alcohol intervention starting in the VHA ED with peer support personnel delivering brief alcohol advice, combined with a continuing 6-session program of post-ED strengths-based peer mentorship to facilitate reductions in alcohol use and to link Veterans with alcohol problems to needed primary and specialty care including other needed services such as homeless outreach and case management where needed. If successful, the proposed study will provide key data on the effectiveness of using peer support specialists in the VHA to help Veterans with hazardous drinking who may have difficulty engaging in needed care that potentially improve their mental and physical health outcomes.

PI_NAMEs: BLOW, FREDERIC C;PFEIFFER, PAUL NELSON (contact)

PROJECT_TERMS: Accident and Emergency department;Acute;addiction;Affect;Age;age group;Alcohol abuse;alcohol abuse therapy;alcohol consequences;Alcohol consumption;alcohol intervention;alcohol related consequences;alcohol risk;alcohol screening;alcohol seeking behavior;alcohol use disorder;Alcohols;Area;Back;behavior change;binge drinking;brief advice;brief alcohol intervention;brief intervention;care outcomes;care seeking;care systems;Caring;Case Management;Clinical;cohort;Communities;comparison intervention;coping;Data;design;drinking;drinking behavior;Educational Intervention;efficacy evaluation;Emergency Care;Emergency Department patient;Emergency department visit;Emotional;Enrollment;Environment;evidence base;experience;Frequencies;hazardous drinking;Health;Health Services Accessibility;Health Services Administration;Healthcare Systems;high risk drinking;Homelessness;Human Resources;Hybrids;implementation facilitators;improved;improved outcome;Individual;Intervention;intervention effect;Interview;Link;Managed Care;Measures;Mediator;Medical;Medical Care Team;Medical center;medical specialties;Mental Health;Mental Health Services;Mentorship;Meta-Analysis;Methods;Morbidity - disease rate;Motivation;Outcome;outreach;Participant;Patients;peer;peer coaching;peer support;physical conditioning;Post-Traumatic Stress Disorders;Primary Care;primary care setting;programs;Provider;psychiatric symptom;Public Health;Randomized;Randomized, Controlled Trials;Reporting;Research;Research Priority;Resources;Role;role model;screening;Self Efficacy;service delivery;Services;Social support;Specialist;Standardization;Structure;substance abuse treatment;suicidal;Symptoms;Time;Training;Treatment Efficacy;United States Health Resources Administration;Use Effectiveness;Veterans;Veterans Health Administration;Vulnerable Populations;War;Writing

PROJECT_TITLE: Improving Outcomes for Emergency Department Patients with Alcohol Problems

STUDY_SECTION_NAME: HSR-4  Mental and Behavioral Health[HSR4]


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Bioengineering;Clinical Research;Data Science;Emerging Infectious Diseases;Infectious Diseases;Influenza;Networking and Information Technology R&D (NITRD);Pneumonia and Influenza

ORG_CITY: LA JOLLA

ORG_NAME: SCRIPPS RESEARCH INSTITUTE, THE

PI_NAMEs: HUGHES, LAURA D. (contact)

PROGRAM_OFFICER_NAME: KWON, KEEHWAN

PROJECT_TERMS: Adoption;Bioinformatics;bioinformatics pipeline;bioinformatics tool;biological systems;Communicable Diseases;Communities;community engagement;Complex;Computer software;computerized tools;Consumption;contextual factors;COVID-19;Data;data exploration;data management;data platform;data portal;data reuse;Data Set;data sharing;data tools;design;Dimensions;Disparate;Ebola;Ecosystem;Education and Outreach;FAIR principles;Generations;Genetic;Genomics;Glues;Goals;heterogenous data;Immunologics;improved;Influenza A Virus, H5N1 Subtype;Infrastructure;innovation;interdisciplinary approach;Knowledge;Lassa;microbial;Mission;Modeling;Molecular;Monitor;multidimensional data;multidisciplinary;novel;open data;Outcome;outreach;pathogen;Physiological;predictive modeling;Proliferating;Publishing;Research;Research Personnel;Software Tools;Systems Biology;Testing;Time;tool;Training;Viral;Virus;Visualization;Visualization software;web platform

PROJECT_TITLE: Data Management and Bioinformatics Core


NIH_SPENDING_CATS: Aging;Assistive Technology;Behavioral and Social Science;Bioengineering;Cardiovascular;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Emergency Care;Health Services;Prevention

ORG_NAME: TRITONX INC.

PHR: Project Narrative Dehydration among older adults a costs billions of dollars in US healthcare every year because no robust solution exists to detect changes in hydration and prevent negative outcomes. In this project TritonX Technologies Inc. and academic research partners plan to test whether a newly created wearable sensor that measures hydration in real time can promote hydration and prevent the dehydration illnesses.

PI_NAMEs: JOHNSON, EAMON  (contact);PIKTEL, JOSEPH ;ROACH, MARY JOAN

PROGRAM_OFFICER_NAME: SAZONOVA, IRINA Y

PROJECT_TERMS: Accident and Emergency department;Achievement;Acute;acute care;Acute Renal Failure with Renal Papillary Necrosis;Adult;Affect;Aftercare;Ambulatory Care;Area;Body Composition;Body Fluids;Body measure procedure;Body System;Cardiovascular system;care outcomes;care providers;Caring;Cessation of life;Clinical;Clinical effectiveness;Clinical Trials;Code;cohort;Communication;comorbidity;Complex;Congestive Heart Failure;cost;Data;Data Science;Death Rate;Decision Making;Dehydration;Devices;Dialysis patients;Disease;Effectiveness;effectiveness evaluation;Emergency Care;Event;Expenditure;experience;Extracellular Fluid;falls;Fluid Shifts;Health;Health behavior;Health Status;Healthcare;Home;Hospital Costs;Hospitalization;Hospitals;Human body;Hydration status;Hypernatremia;Hypotension;improved;Ink;Intake;Knowledge;Laboratories;light weight;Liquid substance;Marketing;Measurement;Measures;Monitor;monitoring device;Morbidity - disease rate;mortality;Names;Neurologic;novel strategies;older adult;Older Population;Outcome;Outcome Study;Patient-Focused Outcomes;Patients;Phase;Population;prevent;Prevention strategy;Process;Randomized, Controlled Trials;Recovery;Reporting;Research;Risk;Sample Size;Self Administration;sensor;Small Business Technology Transfer Research;Sodium;Spectrum Analysis;Survival Rate;Syncope;Techniques;Technology;telehealth;temporal measurement;Testing;Time;time use;Vulnerable Populations;Water consumption;wearable device;wearable sensor technology;Work;Wrist;wrist worn device

PROJECT_TITLE: Clinical effectiveness of a wearable hydration device


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Clinical Research;Clinical Trials and Supportive Activities;Emerging Infectious Diseases;HIV/AIDS;Infectious Diseases;Lung;Orphan Drug;Patient Safety;Pediatric;Pediatric - AIDS;Rare Diseases;Tuberculosis

ORG_CITY: Durban

ORG_COUNTRY: SOUTH AFRICA

ORG_FIPS: SF

ORG_NAME: CENTRE/AIDS PROGRAMME/RES/SOUTH AFRICA

PHR: Project Narrative: Integrase stand transfer inhibitors (InSTI), in particular dolutegravir and bictegravir, are potent, safe, well- tolerated drugs used for the treatment of HIV infection, but we do not yet fully know how to use them in patients with HIV and tuberculosis. Drug interactions with rifampicin, a key first-line tuberculosis drug, reduces exposures to these drugs and may reduce their efficacy, so we will therefore study whether increasing the doses of these drugs can overcome drug interactions and will be safe and effective for the treatment of HIV infection. Specifically, we will examine drug exposures, safety and efficacy of dolutegravir when given twice daily (double dose) to children (20-35kg) with HIV and TB on rifampicin to provide an evidence-base for the use of this drug in this subpopulation, and we will test twice-daily bictegravir/ /emtricitabine/tenofovir alafenamide (BIC/TAF/FTC) in adults with HIV taking tuberculosis treatment to ensure drug concentration and efficacy targets are met.

PI_NAMEs: DOOLEY, KELLY E.;NAIDOO, ANUSHKA  (contact)

PROGRAM_OFFICER_NAME: LOMBO RODRIGUEZ, TANIA

PROJECT_TERMS: ABCB1 gene;Adult;Africa;Africa South of the Sahara;antiretroviral therapy;Area;Child;Clinical;clinically relevant;co-infection;CYP3A4 gene;Data;Dedications;Diphosphates;Dose;Drug Exposure;Drug Interactions;Drug Kinetics;Drug usage;efavirenz;effective therapy;efficacy evaluation;emtricitabine;Enrollment;Ensure;Enzymes;Epidemic;evidence base;Exposure to;Film;Formulation;Fumarates;Future;Generations;Genetic;genetic testing;Goals;healthy volunteer;HIV;HIV Infections;HIV Seronegativity;HIV Seropositivity;HIV-1;HIV/TB;Infection;inhibitor;Integrase;Investigation;Knowledge;Laboratories;Lamivudine;Measures;Medical;mortality;Patients;pediatrician;Persons;Pharmaceutical Preparations;phase III trial;pill;Plasma;Positioning Attribute;Price;Protease Inhibitor;Proteins;Publishing;Qualifying;Randomized;Recommendation;Regimen;Research;Resistance;Resistance development;Resource-limited setting;Rifampin;Safety;Sampling;South Africa;standard of care;Tablets;Tenofovir;Testing;Treatment Protocols;treatment research;Tuberculosis;tuberculosis drugs;tuberculosis treatment;UGT1A1 gene;Viral;Viral Load result;Weight;World Health Organization

PROJECT_TITLE: Second Generation InSTIs for the Treatment of HIV-1 in patients with TB co-infection on Rifampicin-based Treatment in KwaZulu Natal, South Africa


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Behavioral and Social Science;Brain Disorders;Caregiving Research;Clinical Research;Clinical Trials and Supportive Activities;Dementia;Health Services;Neurodegenerative;Neurosciences;Palliative Care;Primary Health Care

ORG_CITY: PROVIDENCE

ORG_NAME: PLANS4CARE INC.

ORG_STATE: RI

PHR: NARRATIVE In response to the lack of scalable, personalized support for family caregivers of people with Alzheimer’s Disease (AD) and AD related Dementias (AD/ADRD), our company, Plans4Care, Inc, proposes a Fast-Track SBIR to build and test a digital platform that delivers personalized care plans to caregivers on a smartphone, tablet or computer. A novel clinical algorithm links >50 care challenges to >1,000 nonpharmacological strategies to generate a personalized care plan that provides disease education and specific strategies to address care challenges and access to telephone sessions with a care advisor as needed. Standardized measures will assess feasibility, acceptability and utility in Phase I, while a randomized trial with 160 caregivers enrolled through primary care will evaluate its effectiveness to improve caregiver wellbeing and reduce health care utilization of people with AD/ADRD in Phase II.

PI_NAMEs: JUTKOWITZ, ERIC ;KOEUTH, SOKHA  (contact)

PROGRAM_OFFICER_NAME: SALIVE, MARCEL

PROJECT_TERMS: Accident and Emergency department;accountable care organization;acute care;Address;Age;Algorithms;Alzheimer's Disease;Alzheimer's disease caregiver;Alzheimer's disease related dementia;burnout;care costs;Caregiver support;Caregiver well-being;Caregivers;Caring;Cellular Phone;Clinical;Clinical Protocols;Coin;commercialization;Communication;Complex;Computer software;Computers;dashboard;Databases;Daughter;Dementia;dementia care;digital;digital platform;Disease;Education;Effectiveness;Elderly;Enrollment;Environment;Ethnic Origin;Evaluation;evidence base;Family;Family Caregiver;family support;Fathers;Feedback;Focus Groups;Friends;Geography;health care service utilization;Healthcare Systems;healthy aging;Home environment;Hospitalization;improved;interest;Intervention;Lead;learning materials;Letters;Libraries;Link;Maps;Marketing;Measures;Modification;Monitor;novel;Nursing Homes;Personal Satisfaction;personalized care;Persons;Phase;Primary Care;primary care practice;primary care provider;programs;prototype;Provider;Race;randomized trial;Randomized, Controlled Trials;response;Risk;Small Business Innovation Research Grant;Sorting;Specialist;standardize measure;Stress;Survey Methodology;Symptoms;Tablets;Technology;telephone session;Testing;Time;tool;Training;United States National Institutes of Health;usability

PROJECT_TITLE: Plans4Care: Personalized Dementia Care On-Demand


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Basic Behavioral and Social Science;Behavioral and Social Science;Brain Disorders;Dementia;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Neurodegenerative;Neurosciences;Prevention;Racial and Ethnic Minority Health Research;Social Determinants of Health

PHR: Project Narrative Though higher education is a strong social determinant of lower risk of Alzheimer’s Disease and Related Dementias (ADRD), large Black-White inequities in ADRD persist among college educated adults. Given that the majority of ADRD studies are comprised of White adults, we must consider educational risk factors that uniquely impact Black Americans to address this disparity, specifically Historically Black Colleges and Universities (HBCUs). This proposed research will advance our understanding of early life exposure to HBCUs as a source of cognitive resilience for Black adults and potential target for future interventions. OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page Continuation Format Page

PI_NAMEs: THOMAS, MARILYN D (contact)

PROGRAM_OFFICER_NAME: TORRES, DELANY

PROJECT_TERMS: Address;Adult;Affect;African American student;Age;Age Years;aged;Alzheimer's disease related dementia;Alzheimer's disease risk;American;aspirate;biopsychosocial;Black American;Black Populations;Black race;Blood Vessels;brain control;California;Capital;career;Cause of Death;Cellular Stress;Chronic stress;Cognition;Cognitive;Cognitive aging;cognitive function;cohort;college;Communities;Community Health;Conflict (Psychology);Data;data harmonization;data integration;Data Set;Death Rate;Degree Completion;Dementia;dementia risk;Discrimination;Disparity;early life exposure;Economics;Education;Education Gap;Educational Status;empowerment;Epidemiologic Methods;Epidemiologist;epidemiology study;experience;Exposure to;Funding;Future;Geographic Locations;Geography;Goals;Health;Health and Retirement Study;health inequalities;Heart Diseases;high school;High School Student;higher education;Historically Black Colleges and Universities;Impaired cognition;improved;Incidence;Inequity;Inflammatory;insight;Institution;Intervention;Interview;Knowledge;Language;late life;Life;Life Cycle Stages;Link;Malignant Neoplasms;Measures;Mediating;Memory;Mentorship;Metabolic;Methods;mortality;multidisciplinary;Neighborhoods;older adult;Outcome;Pathogenesis;Pathway interactions;Policies;Politics;Population;Positioning Attribute;Prevalence;Progressive Disease;Public Health;Quasi-experiment;Race;racial disparity;racial diversity;racism;Randomized;Reasons for Geographic And Racial Differences in Stroke;Reduce health disparities;Reporting;Research;resilience;Risk Factors;Role;Sampling;San Francisco;skills;social;social determinants;Source;Stress;Structural Racism;success;Talents;thought control;Time;Training;Training Activity;United States;Universities;vascular risk factor

PROJECT_TITLE: Impact of Historically Black Colleges and Universities on Late-life Cognition in Black Adults

STUDY_SECTION: NSS

STUDY_SECTION_NAME: NSS


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Behavioral and Social Science;Brain Disorders;Chronic Pain;Clinical Research;Dementia;Dietary Supplements;Genetics;Human Genome;Neurodegenerative;Neurosciences;Nutrition;Pain Research;Prevention

ORG_CITY: GAINESVILLE

ORG_DEPT: NEUROSCIENCES

ORG_NAME: UNIVERSITY OF FLORIDA

PHR: PROJECT NARRATIVE Chronic pain and Alzheimer’s Disease are related, major health concerns and that have increasing evidence supporting their overlapping etiologies and pathologies, and there is an urgent need to understand the mechanisms contributing to the development of these comorbid conditions as the population ages. Epigenetic modifications contributing to immune system dysfunction have been highlighted as a critical factor contributing to both chronic pain and AD/ADRD development. The proposed work will elucidate nutrigenomic mechanisms associated with related to pain and cognition, assess nutritional supplementation on epigenetic mechanisms related to pain and cognitive decline in older adults, and findings will have strong implications for advancement of pain management and AD/ADRD prevention strategies in older adult populations.

PI_NAMEs: STRATH, LARISSA J (contact)

PROGRAM_OFFICER_NAME: FRANKOWSKI, DAVID WITT

PROJECT_TERMS: accelerated epigenetic aging;Achievement;Address;Affect;Age;age related;age-related disease;Aging;aging population;Alzheimer's Disease;Alzheimer's disease patient;Alzheimer's disease related dementia;Ancillary Study;career development;Cell Aging;Chronic;chronic pain;chronic painful condition;clinical pain;Clinical Research;Cognition;Cognitive;Cognitive aging;cognitive function;Communities;comorbidity;Consumption;Data;Dementia;design;Development;Development Plans;Diagnosis;Diet;dietary;Dietary Assessment;Dietary Intervention;Disease;DNA Methylation;Early identification;effective therapy;Environment;Environmental Risk Factor;epigenetic aging;epigenetic clock;Epigenetic Process;epigenetic regulation;epigenome;epigenomics;Etiology;forging;Functional disorder;Future;Gene Expression;Genes;genome-wide;Goals;Grant;Health;High Prevalence;Human;Immune;Immune system;Immune System Diseases;Impaired cognition;improved;indexing;Individual;Inflammation;Inflammatory;innovation;Institution;Intervention;K-Series Research Career Programs;knee pain;Knowledge;late life;Link;Literature;Maintenance;Measurement;Mediating;Mentors;Methylation;methylation pattern;middle age;mild cognitive impairment;Modality;Modification;Morbidity - disease rate;multidisciplinary;Nervous System;novel;Nutrient;nutrition;Nutrition Assessment;Nutritional;nutritional genomics;Nutritional status;nutritional supplementation;older adult;Outcome;Pain;Pain Free;Pain management;pain outcome;Pathologic;Pathology;Pathway interactions;Pattern;Persons;Phase;Physiological;Population;pre-clinical;Prevalence;Prevention;Prevention strategy;protein expression;Reporting;Research;Research Personnel;Risk;Serum;side effect;skills;standardize measure;Statistical Data Interpretation;Symptoms;Techniques;Testing;Training;Translational Research;translational scientist;Vitamin A;Vitamin D;Work

PROJECT_TITLE: Pain and Nutrition in Dementia and Alzheimer's-2 (PANDA-2)


ED_INST_TYPE: ORGANIZED RESEARCH UNITS

NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Biotechnology;Clinical Research;Emerging Infectious Diseases;Genetics;Immunization;Infectious Diseases;Lung;Orphan Drug;Prevention;Rare Diseases;Vaccine Related;Valley Fever

ORG_CITY: FLAGSTAFF

ORG_DEPT: MISCELLANEOUS

ORG_NAME: NORTHERN ARIZONA UNIVERSITY

ORG_STATE: AZ

PHR: NARRATIVE Valley Fever is a fungal disease that causes mortality and morbidity across a large range of the western United States. Our work will lead to a better understanding of the fungal infective process, which will help in the development of prevention, therapeutic, and diagnostic strategies. Our ultimate goal is the development of a highly efficacious nucleic acid vaccine to provide protection against Valley Fever.

PI_NAMEs: KEIM, PAUL STEPHEN (contact)

PROGRAM_OFFICER_NAME: LOVE, DONA

PROJECT_TERMS: Animal Model;Animals;Antibodies;Antigens;Basic Science;Clinical;clinical research site;Clinical Trials;Coccidioides;Coccidioides immitis;Coccidioides posadasii;Coccidioidomycosis;Communities;companion diagnostics;Complex;CRISPR/Cas technology;Data;desert fever;design;Development;Diagnostic;diagnostic development;diagnostic signature;diagnostic strategy;Diagnostic tests;diagnostic tool;Disease;disease diagnosis;DNA;DNA sequencing;DNA Vaccines;Epitopes;Gene Expression;Gene Expression Profile;gene gun;gene product;Genes;Goals;Human;human disease;Immune;Immune response;Immunization;in vivo;Infection;Infrastructure;Insecta;insight;Institution;Knock-out;knockout gene;Knowledge;Link;Lipids;Location;longitudinal analysis;Macaca nemestrina;Messenger RNA;Modality;Modeling;Morbidity - disease rate;mortality;mouse model;Mus;nano-string;nanoGold;nanoparticle;nonhuman primate;novel;novel diagnostics;novel vaccines;Nucleic Acid Amplification Tests;Nucleic Acid Vaccines;Nucleic Acids;pathogen;Pathogenesis;Patients;Pattern;Peptides;Population;prevent;Prevention;Process;Protein Secretion;Proteins;Research;Research Personnel;Research Project Grants;respiratory;response;RNA;RNA replication;RNA vaccination;RNA vaccine;Role;screening;serological marker;Serology test;T cell response;T-Cell Receptor;T-cell receptor repertoire;T-Lymphocyte;Technology;Testing;Therapeutic;Therapeutic Agents;therapeutic evaluation;Time;tool;transcriptome sequencing;Translational Research;United States;Vaccination;Vaccine Antigen;vaccine candidate;Vaccine Design;vaccine development;vaccine evaluation;Vaccines;Vertebrates;Virulence;Virulence Factors;virulence gene;Waxes;Work

PROJECT_TITLE: Early in vivo Expressed Antigens and their Role in Virulence, Immune Response, and Vaccines for Coccidioidomycosis


ADMINISTERING_IC: TW

IC_NAME: FOGARTY INTERNATIONAL CENTER

NIH_SPENDING_CATS: Clinical Research

ORG_CITY: CHAPEL HILL

ORG_NAME: UNIV OF NORTH CAROLINA CHAPEL HILL

PHR: NARRATIVE The proposed Fogarty Pathway Program is an intensive, four-week curriculum designed to train US doctoral students from the Morehouse School of Medicine. Developed with institutional partners from Ghana and Jamaica, this pathway initiative will recruit individuals from diverse backgrounds and provide mentorship and individualized support to catalyze careers in global health research.

PI_NAMEs: CHI, BENJAMIN H. (contact);KONDWANI, KOFI A

PROGRAM_OFFICER_NAME: KATZ, FLORA N

PROJECT_TERMS: Active Learning;Address;Area;career;design;Doctor of Philosophy;doctoral student;Educational Curriculum;Educational process of instructing;Environment;Ethnic Origin;experience;Faculty;Fostering;Ghana;global health;Growth;Hemoglobinopathies;Individual;Institution;interest;International;Investments;Jamaica;Medical;Mentors;Morehouse School of Medicine;NIH Program Announcements;Outcome;parent project;Participant;Pathway interactions;Phase;programs;Race;recruit;Research;Students;Training;United States National Institutes of Health;Work

PROJECT_TITLE: UJMT – Morehouse School of Medicine Supplement


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

ORG_CITY: VALHALLA

ORG_DEPT: PHARMACOLOGY

ORG_NAME: NEW YORK MEDICAL COLLEGE

PHR: Hypertension is an important risk factor for the development of heart disease, stroke, and kidney disease that affects greater than 40% of the population in the United States. Many hypertensive patients, especially African Americans, exhibit sensitivity to salt. Exaggerated stimulation of ion transporters in the kidney of these individuals increases the retention of salt, which heightens elevations in blood pressure associated with an increase in dietary salt intake. Our study will determine the mechanisms that regulate an intratubular TNF system that is activated in renal epithelial cells in response to increases in dietary salt intake and attenuates salt-dependent increases in blood pressure.

PI_NAMEs: FERRERI, NICHOLAS R (contact)

PROGRAM_OFFICER_NAME: VARAGIC, JASMINA

PROJECT_TERMS: absorption;Address;Affect;African American population;Angiotensinogen;Attenuated;Binding;Blood Pressure;blood pressure control;blood pressure elevation;blood pressure reduction;blood pressure regulation;Calcineurin;Calcineurin inhibitor;Cardiovascular Diseases;cardiovascular risk factor;Catalytic Domain;cell type;Chronic;Cyclosporine;cytokine;Data;Development;dietary salt;Distal;Electrolytes;Epithelial Cells;Excretory function;Exhibits;experimental study;Framingham Heart Study;Functional disorder;Genes;Genetic;Heart Diseases;Homeostasis;Human;Hypertension;hypertensive;Individual;Inflammatory;Ingestion;Intake;Ions;Kidney;kidney cell;Kidney Diseases;Lentivirus;Limb structure;Macula densa;Mediating;member;Messenger RNA;MicroRNAs;miRNA expression profiling;Molecular;mortality risk;mouse model;mRNA Transcript Degradation;Mus;Mutation;Nephrons;novel;Nucleotides;Patients;Phosphoric Monoester Hydrolases;Phosphorylation;Play;Population;posttranscriptional;PPP3CA gene;Production;Protein Isoforms;receptor;Regulation;renal epithelium;Renal function;Renal tubule structure;Renin-Angiotensin System;response;Risk Factors;Role;salt intake;saluretic;screening;Serine;side effect;Sodium Chloride;Source;Stroke;Structure of ascending limb of Henle's loop;symporter;System;Tacrolimus;Thick;Threonine;TNF gene;TNFRSF1A gene;Tubular formation;Tumor Necrosis Factor Activation;United States;Untranslated Regions;Untranslated RNA;Up-Regulation;Water

PROJECT_TITLE: Regulation of NKCC2 isoforms and blood pressure by tumor necrosis factor-alpha

STUDY_SECTION: IVPP

STUDY_SECTION_NAME: Integrative Vascular Physiology and Pathology Study Section[IVPP]


ED_INST_TYPE: HOSPITALS

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);Basic Behavioral and Social Science;Behavioral and Social Science;Brain Disorders;Cerebrovascular;Dementia;Neurodegenerative;Neurosciences;Vascular Contributions to Cognitive Impairment and Dementia (VCID)

ORG_CITY: HOUSTON

ORG_NAME: UNIVERSITY OF TX MD ANDERSON CAN CTR

PHR: Projective Narrative Alzheimer’s disease (AD) and age-associated neurodegenerative disorders are a major public health concern. The proposed studies aim to further develop squirrel monkeys as a model species for studies on cognitive aging and their potential associations with neurological and pathological changes in the central nervous system. Further development of primate models for studies on AD pathology and related dementias will provide new and alternative avenues of therapeutic interventions with increased translational value compared to other model species.

PI_NAMEs: HOPKINS, WILLIAM D (contact);SCHOLTZOVA, HENRIETA

PROGRAM_OFFICER_NAME: WAGSTER, MOLLY V

PROJECT_TERMS: abeta deposition;Activity Cycles;Age;age difference;age related changes;age related neurodegeneration;aged;aging brain;aging process;Alzheimer's Disease;Alzheimer's disease model;Alzheimer's disease pathology;Alzheimer's disease patient;Alzheimer's disease related dementia;Alzheimer's disease therapeutic;Alzheimer’s disease biomarker;Amyloid;Amyloid beta-Protein;Animal Model;Animals;Autopsy;Behavior;Behavioral;Biological;Biological Markers;Biology of Aging;Blood;Blood specimen;Brain;Central Nervous System;Cerebral Amyloid Angiopathy;Cerebrovascular system;Cognition;Cognitive;Cognitive aging;cognitive function;cognitive neuroscience;cognitive task;cognitive testing;cognitive training;cohort;Comparative Biology;Complex;Consensus;Control Groups;Data;Dementia;design;Development;Disease;early onset;effective therapy;Elderly;Euthanasia;executive function;Failure;Fertility;Future;Genetically Engineered Mouse;Goals;gray matter;Health;Human;Image;Impaired cognition;improved;Individual;insight;interest;Knowledge;Learning;life history;life span;Macaca mulatta;Magnetic Resonance Imaging;Mammals;Measurement;Measures;Memory;microchip;model organism;Modeling;Monkeys;Motivation;mouse model;MRI Scans;Nerve Degeneration;neural;Neuroanatomy;Neurobiology;Neurofibrillary Tangles;neuroinflammation;Neurologic;neuropathology;Neuropsychology;Neurosciences Research;neurovascular;nonhuman primate;Pathologic;Pathology;Patients;Phase;Phenotype;pre-clinical;preclinical study;premature;Prevalence;primate development;Primates;Process;programs;Public Health;Randomized;Reader;Research;Research Design;Resources;Rodent;Rodent Model;Saimiri;Sampling;Scientist;sex;social;Social Functioning;social group;Social Interaction;Study models;System;tau Proteins;Testing;Therapeutic;Therapeutic Intervention;Therapeutic Trials;Time;Training;Transgenic Mice;Translations;Variant;virtual;white matter

PROJECT_TITLE: A Squirrel Monkey Model of Alzheimer’s Disease: Developing Behavioral, Blood, and CSF Biomarkers


NIH_SPENDING_CATS: Autoimmune Disease;Clinical Research;Clinical Trials and Supportive Activities;Diabetes;Digestive Diseases;Pediatric;Prevention

ORG_DEPT: PEDIATRICS

PHR: PROJECT NARRATIVE. Many people think of type 1 diabetes as an autoimmune disease of the insulin-producing cells of the pancreas, however, the exocrine pancreas, which is involved in digestion, is also substantially impacted. The primary goal of this project is to determine when in the development of type 1 diabetes the exocrine pancreas becomes affected and whether stool or blood exocrine pancreas markers predict the onset of type 1 diabetes in those who are at risk. The secondary goal of this project is to investigate what is specifically causing the exocrine pancreas changes seen in type 1 diabetes.

PI_NAMEs: BRUGGEMAN, BRITTANY  (contact)

PROGRAM_OFFICER_NAME: SPAIN, LISA M

PROJECT_TERMS: Affect;Amylases;Atrophic;Autoantibodies;Autoimmune;Autoimmune Diseases;Autoimmunity;Autologous;Beta Cell;Biological Markers;biomarker evaluation;Birth;Blood;career;career development;Cells;Childhood;Clinical;Clinical Investigator;Clinical Markers;Clinical Research;cohort;Cohort Studies;Collaborations;Data;density;Deposition;design;Development;Development Plans;Diabetes Mellitus;diabetes pathogenesis;diabetes risk;Diagnosis;Digestion;Disease;early detection biomarkers;Early identification;Elastases;Endocrine;Endocrinologist;Enrollment;Environment;Evaluation;Event;Exocrine pancreas;Exocrine pancreatic insufficiency;experience;Feces;First Degree Relative;Florida;Functional disorder;functional loss;Funding;Gene Expression;Goals;Heterogeneity;high risk;Human Subject Research;Immune;immune cell infiltrate;Immunoglobulin G;Individual;Inflammatory;Insulin;insulin dependent diabetes mellitus onset;insulin secretion;Insulin-Dependent Diabetes Mellitus;Intervention;Intervention Trial;islet;islet autoimmunity;islet cell antibody;Knowledge;Lead;Learning;Lipase;loss of function;Magnetic Resonance Imaging;Measures;Mentors;Mentorship;Mission;Natural History;next generation;novel;Onset of illness;Organ Donor;Organ Size;Pancreas;Pathogenesis;patient oriented;Patients;Persons;Phenotype;Play;Population;pre-clinical;predictive marker;Prevention strategy;Prevention trial;prognostic value;prospective;protein expression;Research;research clinical testing;Research Design;Research Personnel;Research Proposals;Research Technics;Risk;Risk Marker;Role;Sampling;Scientist;Serum;skills;Slice;success;Techniques;Tissues;Training;Translational Research;treatment response;trial design;Trypsinogen;Universities;Work

PROJECT_TITLE: Natural History and Mechanisms of Exocrine Pancreatic Dysfunction in Pre-Type 1 Diabetes

STUDY_SECTION: DDK

STUDY_SECTION_NAME: Diabetes, Endocrinology and Metabolic Diseases B Study Section[DDK-B]


ED_INST_TYPE: SCHOOLS OF NURSING

NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Clinical Research;Coronaviruses;Coronaviruses Disparities and At-Risk Populations;Emerging Infectious Diseases;Infectious Diseases;Prevention

ORG_CITY: IRVINE

ORG_DEPT: OTHER HEALTH PROFESSIONS

ORG_NAME: UNIVERSITY OF CALIFORNIA-IRVINE

PHR: PROJECT NARRATIVE  Immunosuppressive conditions, such as HIV infection, may play a major role in SARS-CoV-2 transmission and emergence of variants of concern. We will use advanced molecular methods to determine the effect of HIV infection on SARS-CoV-2 evolution and epidemiology in a high HIV-prevalent country. Information from our study could be used to develop interventions to prevent and prepare for emergence of SARS-CoV-2 variants of concern.

PI_NAMEs: MODONGO, CHAWANGWA ;NIEMANN, STEFAN ;SHIN, SANGHYUK SAM (contact)

PROGRAM_OFFICER_NAME: HUEBNER, ROBIN E

PROJECT_TERMS: 2019-nCoV;Affect;Area;Botswana;case finding;Case Study;CD4 Positive T Lymphocytes;Cell Count;Cells;Chronic;chronic infection;Clinical;Clinical Data;co-infection;cohort;Cohort Studies;Communities;comorbidity;Country;COVID-19;COVID-19 impact;COVID-19 incidence;COVID-19 pandemic;COVID-19 patient;COVID-19 prevention;COVID-19 severity;COVID-19 treatment;COVID-19 vaccine;Data;Development;Disease;DNA Sequence Alteration;Environment;Epidemic;epidemiologic data;Epidemiology;epidemiology study;Event;Evolution;experience;Foundations;Functional disorder;Future;future pandemic;Genetic Recombination;genome sequencing;genomic data;genomic epidemiology;global health;Goals;Health;High Prevalence;high risk;HIV;HIV Infections;Household;Immune;Immune system;Immunity;Immunocompetent;Immunocompromised Host;immunodeficiency;Immunosuppression;improved;Individual;Infection;insight;interest;Intervention;Knowledge;Methods;Molecular;Monitor;Mutation;National Institute of Allergy and Infectious Disease;pandemic disease;pandemic disruption;pandemic response;Patients;Pattern;Persons;Play;Population;population based;pressure;Prevalence;prevent;programs;Public Health;public health intervention;recruit;Research;Resistance;Risk Factors;RNA;Role;Sampling;Sampling Biases;SARS-CoV-2 B.1.1.529;SARS-CoV-2 B.1.617.2;SARS-CoV-2 genome;SARS-CoV-2 infection;SARS-CoV-2 transmission;SARS-CoV-2 variant;Subgroup;System;Time;transmission process;Tuberculosis;Vaccination;Variant;variants of concern;Viral;Viral Load result;Virus;whole genome

PROJECT_TITLE: The effect of HIV on SARS-CoV-2 transmission and emergence of variants of concern

STUDY_SECTION: PPAH

STUDY_SECTION_NAME: Population and Public Health Approaches to HIV/AIDS Study Section[PPAH]


NIH_SPENDING_CATS: Biotechnology;Genetics;Networking and Information Technology R&D (NITRD)

ORG_CITY: PITTSBURGH

ORG_NAME: UNIVERSITY OF PITTSBURGH AT PITTSBURGH

ORG_STATE: PA

PHR: Principal Investigator (Wright, Erik S.) Project Narrative: Genomes harbor an immense amount of untapped information that could provide valuable insights into the interactions and functions of genes within cells. This work will develop a network of coevolving genes spanning many different microorganisms and make it publicly accessible as an online tool for biomedical research.

PI_NAMEs: WRIGHT, ERIK SCOTT (contact)

PROGRAM_OFFICER_NAME: SASTALLA, INKA I

PROJECT_TERMS: Acceleration;Acute;Address;Algorithms;Antibiotic Resistance;Archaeal Genome;Architecture;Astronomy;Bacterial Genome;base;Benchmarking;Bioinformatics;Biomedical Research;Cell Physiology;Cells;Classification;Collection;Color;comparative genomics;Computer software;Computers;Consumption;dark matter;Darkness;Data;Databases;Disease;DNA;Drug Targeting;Evolution;Fruit;Fungal Genome;Genbank;gene function;Genes;Genetic;genetic information;Genome;genome annotation;Genomics;Guilt;Height;Hypothetical Protein;Inequality;innovation;insight;Knowledge;Label;Laboratories;Letters;Life;Light;Link;link protein;Machine Learning;Maps;Methods;microbial;microbial genome;microorganism;Mutation;Names;neglect;new therapeutic target;novel;open data;open source;Organism;Orthologous Gene;Output;pan-genome;pathogen;Pathogenicity;Pathway interactions;pressure;Principal Investigator;programs;Proteins;Proteome;Regulation;Research;Resources;Role;Signal Transduction;Software Validation;Surface;System;Techniques;Time;tool;Trees;Virulence;web app;web site;web-based tool;Work

PROJECT_TITLE: Connecting the universe of proteins to address annotation inequality in the microbial proteome


NIH_SPENDING_CATS: Anxiety Disorders;Basic Behavioral and Social Science;Behavioral and Social Science;Brain Disorders;Cocaine;Depression;Drug Abuse (NIDA only);Mental Health;Mental Illness;Neurosciences;Stimulant Use and Misuse;Substance Misuse

ORG_CITY: NEW HAVEN

ORG_NAME: YALE UNIVERSITY

ORG_STATE: CT

PHR: The comorbidity between substance abuse and mood disorders is an ongoing challenge for the mental health field, with a need for improved understanding of the mechanisms underlying these comorbid illnesses. The goal of this project is to identify the role of L-type calcium channels (LTCC) in mediating mood disorder phenotypes after repeated cocaine or repeated stress exposure. This work in rodent models will address a significant gap in current scientific understanding, will identify mechanisms by which LTCC blockade produces antidepressant and anxiolytic effects, and will provide a strong foundation for future clinical and therapeutic focused investigations.

PI_NAMEs: ADDY, NII A (contact)

PROGRAM_OFFICER_NAME: MOORE, HOLLY MARIE

PROJECT_TERMS: Abstinence;Address;Anti-Anxiety Agents;anti-depressive agents;antidepressant effect;Anxiety;Anxiety Disorders;associated symptom;Attenuated;Behavior;Behavioral;behavioral pharmacology;behavioral response;Bipolar Disorder;Brain;Calcium Channel Blockers;Chronic;Chronic stress;Clinical;Clinical Trials;Cocaine;Cocaine Dependence;cocaine exposure;cocaine seeking;cocaine self-administration;comorbidity;Cues;Data;Disease;disorder risk;Dopamine;drug abstinence;drug of abuse;drug seeking behavior;Electrochemistry;Exposure to;Female;Foundations;Future;gain of function mutation;Genes;Goals;High Prevalence;Human;improved;in vivo;Individual;inhibitor;Intravenous;Investigation;Isradipine;Knowledge;L-Type Calcium Channels;Laboratories;Major Depressive Disorder;male;Mediating;Mental Depression;Mental Health;mesolimbic system;Mood Disorders;Moods;mouse model;neurobiological mechanism;neuropsychiatric disorder;novel;novel therapeutic intervention;Nucleus Accumbens;Pathway interactions;Periodicity;Pharmaceutical Preparations;Phenotype;Pilot Projects;pre-clinical;Rattus;Regulation;Research;Rewards;risk variant;Rodent;Rodent Model;Role;Scanning;Self Administration;Signal Transduction;social;social deficits;Social Interaction;Stress;Substance abuse problem;substance use;Substance Use Disorder;Sucrose;Symptoms;Testing;Therapeutic;Therapeutic Intervention;therapeutic target;therapeutically effective;tool;Ventral Tegmental Area;Work

PROJECT_TITLE: L-Type Calcium Channel Mechanisms Mediating Comorbid Substance Use and Mood Disorders


NIH_SPENDING_CATS: Biotechnology;Clinical Research;Diabetes;Genetics;Nutrition;Stem Cell Research;Stem Cell Research - Embryonic - Human

ORG_CITY: PHILADELPHIA

ORG_NAME: CHILDREN'S HOSP OF PHILADELPHIA

PHR: Project Narrative The role of the pancreatic b-cell is to secrete insulin in response to glucose. Defects in this process can result in inadequate insulin secretion causing diabetes or excessive insulin secretion causing hyperinsulinism. The goal of this project is to understand how the same mutations in the transcription factor HNF1a can cause both of these opposing diseases through disruption at different points along the insulin secretion cascade.

PI_NAMEs: LEAVENS, KARLA FITZGERALD (contact)

PROGRAM_OFFICER_NAME: BLONDEL, OLIVIER

PROJECT_TERMS: Acute;Advisory Committees;Age;Amino Acids;Applications Grants;Area;Automobile Driving;B-Lymphocytes;Basic Science;Beta Cell;Biological Models;Candidate Disease Gene;career development;Cell Maturation;Cell model;Cells;Clinical;Communities;Complex;Coupled;Data;Defect;Development Plans;Diabetes Mellitus;directed differentiation;Disease;Dissociation;Down-Regulation;drug action;Educational workshop;energy balance;Environment;Exhibits;experimental study;Foundations;Functional disorder;Future;Gene Mutation;Generations;Genes;genome editing;Glucose;glucose metabolism;Glycolysis;Goals;Heterozygote;Human;human stem cell-derived;Hyperinsulinism;Individual;Insulin;Insulin deficiency;insulin secretion;Knowledge;knowledge base;Learning;Link;loss of function;loss of function mutation;Measures;Mediator;medical schools;Mendelian disorder;Mentors;Metabolic;Metabolism;Methods;Modeling;Mus;mutant;Mutation;NADH;NADP;novel;Nutrient;Pathogenesis;Pathway interactions;Patients;Pediatric Hospitals;Pennsylvania;Persistent Hyperinsulinemia Hypoglycemia of Infancy;Phase;Philadelphia;Process;Production;Publications;Publishing;Regulation;Research;response;RNA Interference;Role;Signal Pathway;skills;stem cells;Structure of beta Cell of islet;Techniques;Testing;Training;transcription factor;Translational Research;transplant model;type I and type II diabetes;Universities;Work;Xenograft procedure

PROJECT_TITLE: Dissecting the mechanisms behind biphasic beta cell disease caused by mutations in HNF1alpha


NIH_SPENDING_CATS: Clinical Research;Cystic Fibrosis;Lung;Rare Diseases

ORG_NAME: UNIVERSITY OF IOWA

PHR: PROJECT NARRATIVE CD4+ T cells from Cftr deficient mice have recently been shown to have increased CD4+ Th2 cytokine production, and our preliminary studies suggest CFTR may function as a GATA3 responsive negative regulator of CD4+ Th2 polarization and effector function. In this proposal, we will use CD4+ T cells from mice and humans, a murine in vivo allergen model of Th2 inflammation, and electronic health record data to investigate the mechanisms of CFTR in Th2 inflammation and test whether CFTR modulation can reduce allergic inflammation.

PI_NAMEs: COOK, DANIEL PAUL (contact)

PROGRAM_OFFICER_NAME: GONDRE-LEWIS, TIMOTHY A

PROJECT_TERMS: Address;airborne allergen;Airway Disease;airway inflammation;Allergens;Allergic;allergic airway inflammation;Allergic Bronchopulmonary Aspergillosis;Allergic Disease;Allergic inflammation;Alternaria;Animal Model;Anions;antagonist;Asthma;Attenuated;Award;Bacterial Artificial Chromosomes;Bicarbonates;Binding;Biological Markers;CD4 Positive T Lymphocytes;Cell Differentiation process;Cell Physiology;Cells;Cellular biology;Child;Chronic;Clinical;Clinical Research;clinically significant;Clustered Regularly Interspaced Short Palindromic Repeats;cohort;Computer Analysis;Computerized Medical Record;Cystic Fibrosis;cystic fibrosis airway;cystic fibrosis patients;Cystic Fibrosis Transmembrane Conductance Regulator;cytokine;Cytokine Gene;Data;Development;Disease;Electronic Health Record;eosinophil;experimental study;FDA approved;Flow Cytometry;GATA3 gene;gene repression;General Population;Genes;Genetic Transcription;Genomics;Goals;Helper-Inducer T-Lymphocyte;Hemostatic Agents;Human;IgE;Immunologist;Immunology;In Vitro;in vivo;Inbred CFTR Mice;Inflammation;Inflammatory;Inflammatory Response;Interleukin-13;Interleukin-4;Interleukin-5;knowledgebase;Laboratory Study;large datasets;Lung;Maintenance;Mediating;Modeling;mortality risk;mouse model;Mucous Membrane;Mus;mutant;Mutation;novel;novel therapeutic intervention;overexpression;Pathogenesis;pathogenic bacteria;pathogenic fungus;Patients;Persons;Phenotype;Physicians;Prevalence;Production;promoter;Proteins;Regulation;Regulatory Element;Repression;Respiratory Disease;response;Role;Scientist;Serum;Signal Transduction;small molecule;T-Cell Activation;T-Lymphocyte;Technology;Testing;Thyroid Hormone Receptor Beta;Tissues;Training;Transgenic Mice;VX-770

PROJECT_TITLE: Inhibiting CD4+ Th2 development and function by CFTR activity

STUDY_SECTION: AITC

STUDY_SECTION_NAME: Allergy, Immunology, and Transplantation Research Committee[AITC]


NIH_SPENDING_CATS: Bioengineering;Biotechnology;HIV/AIDS;Immunization;Infectious Diseases;Prevention;Vaccine Related;Vaccine Related - AIDS

ORG_NAME: UNIVERSITY OF PENNSYLVANIA

PHR: PROJECT NARRATIVE A major obstacle to rational HIV-1 vaccine design is the lack of an outbred primate animal model where the induction of broadly neutralizing antibodies (bNAbs) can be achieved in a consistent and reproducible manner and the molecular events leading to bNAb elicitation deciphered. This application proposes a novel “reverse vaccinology” strategy to overcome this roadblock leading to new immunogen designs and a pivotal proof-of-concept preclinical immunogenicity and protection trial in rhesus macaques. This trial will test the ability of a germline-targeted Q23.17 SOSIP Env prime, followed by lineage-designed Q23.17 SOSIP Env trimer boosts, to elicit bNAbs that protect monkeys from a heterologous tier 2 virus challenge.

PI_NAMEs: SHAW, GEORGE M (contact)

PROGRAM_OFFICER_NAME: CHAKRABARTI, BIMAL KUMAR

PROJECT_TERMS: Acceleration;Affinity;Amino Acid Substitution;Animal Model;Animals;Antibodies;Antibody Response;Antibody-mediated protection;Antigens;Apical;Autologous;B-Lymphocytes;Binding;Binding Sites;Biological;Chemicals;Chronic;Clinical Trials;Data;design;Development;Engineering;Epitopes;Event;Exhibits;Frequencies;Germ Lines;Grant;HIV-1;HIV-1 vaccine;Human;Immunogenetics;immunogenicity;Immunologics;innovation;insertion/deletion mutation;Knock-in Mouse;Laboratories;Macaca mulatta;Mature B-Lymphocyte;Modeling;Molecular;Monkeys;Mutagenesis;Mutation;nanoparticle delivery;neutralizing antibody;novel;Pathway interactions;Pattern;Peptides;Polysaccharides;pre-clinical;Prevalence;Primates;Regimen;Reproducibility;response;Reverse engineering;Rhesus;Science;Scientific Advances and Accomplishments;simian human immunodeficiency virus;Structure;Testing;Time;Translating;transmission process;Vaccination;Vaccine Design;Vaccine Research;vaccine trial;Vaccines;vaccinology;Variant;Viral;Virus

PROJECT_TITLE: HIV-1 Q23.17 Env: Engineering a novel immunogen to elicit broadly neutralizing antibodies

STUDY_SECTION: HIVD

STUDY_SECTION_NAME: HIV Immunopathogenesis and Vaccine Development Study Section[HIVD]


NIH_SPENDING_CATS: Aging;Atherosclerosis;Cardiovascular;Heart Disease;Heart Disease - Coronary Heart Disease;Infectious Diseases;Tickborne Diseases;Vector-Borne Diseases

ORG_CITY: CHARLOTTESVILLE

ORG_DEPT: MICROBIOLOGY/IMMUN/VIROLOGY

ORG_NAME: UNIVERSITY OF VIRGINIA

ORG_STATE: VA

PHR: NARRATIVE Humans with IgE sensitization to the mammalian oligosaccharide allergen galactose-a-1,3- galactose (a-gal) have larger coronary artery plaques and unstable plaque features signifying increased coronary artery disease (CAD) compared to those without IgE to a-gal. However, the causal role of IgE to a-gal in CAD is unknown. The proposed research seeks to understand whether IgE to a-gal directly promotes atherosclerotic plaque development and define immune mechanisms mediating IgE sensitization to a-gal linked to atherosclerotic cardiovascular disease in mice and humans.

PI_NAMEs: ERICKSON, LOREN D (contact);MCNAMARA, COLEEN A

PROGRAM_OFFICER_NAME: SUBRAMANIAN, HARIHARAN

PROJECT_TERMS: Address;Allergens;allergic response;alpha-gal syndrome;Ambylomma americanum;Anaphylaxis;Antibody Formation;Antibody Response;Antigens;Arterial Fatty Streak;Atherosclerosis;Attenuated;Automobile Driving;B-Lymphocytes;Bite;Blood Vessels;CCR6 gene;Cells;cohort;comparison control;Consumption;Coronary Angiography;Coronary Arteriosclerosis;Coronary artery;Dairying;Data;Development;Diet;Enzymes;Etiology;Exposure to;Food;Fostering;Frequencies;gain of function;Galactose;galactosyl-(1-3)galactose;Galactosyltransferases;High Prevalence;Histology;Human;humanized mouse;hypercholesterolemia;Hypersensitivity;IgE;Immediate hypersensitivity;Immune;Immunoglobulin Class Switching;Immunoglobulin Switch Recombination;Individual;Inflammation;Ingestion;Interleukin 4 Receptor;Interleukin-4;Link;Lipids;loss of function;Mammals;Measures;Meat;Mediating;Memory B-Lymphocyte;Modeling;Molecular;mouse model;multiple omics;Multivariate Analysis;Mus;Necrosis;novel;Oligosaccharides;Peripheral Blood Mononuclear Cell;Phenotype;Play;Population;Pre-Clinical Model;Production;Reaction;Regulation;Research;response;Risk;Role;Serum;Severity of illness;single cell analysis;STAT6 gene;Structure of germinal center of lymph node;Symptoms;Testing;Ticks;transcriptomics;ultrasound;vascular inflammation;virtual;Wild Type Mouse;Work

PROJECT_TITLE: IgE antibody responses to the oligosaccharide galactose-alpha-1,3-galactose (alpha-gal) in murine and human atherosclerosis

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


ADMINISTERING_IC: HD

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

NIH_SPENDING_CATS: Clinical Research;Clinical Trials and Supportive Activities;Infant Mortality;Lung;Neonatal Respiratory Distress;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Preterm, Low Birth Weight and Health of the Newborn;Prevention

ORG_CITY: RESEARCH TRIANGLE PARK

ORG_NAME: RESEARCH TRIANGLE INSTITUTE

ORG_STATE: NC

PHR: PROJECT NARRATIVE NICHD established the Neonatal Research Network to investigate persistent unanswered questions regarding the safety and efficacy of treatment and management strategies for newborn infants. A Data Coordinating Center (DCC) provides essential expertise to such a large multicenter research enterprise by ensuring rigorous and consistent standards for study design, development, data collection, and data analyses. The DCC also provides objective statistical expertise for formulating, designing, and analyzing studies (especially, masked randomized trials and monitoring thereof), and coordinates communications, regulatory and logistical support across diverse clinical centers, both inside and outside the Network.

PI_NAMEs: DAS, ABHIK  (contact)

PROGRAM_OFFICER_NAME: CHAKHTOURA, NAHIDA ABDO

PROJECT_TERMS: Address;Biometry;clinical center;clinical practice;Clinical Research;Collaborations;Communication;Data;Data Analyses;Data Collection;Data Coordinating Center;Data Management Resources;data quality;data sharing;design;Development;Ensure;experience;Feasibility Studies;flexibility;Goals;Infrastructure;innovation;Knowledge;Masks;Monitor;Multicenter Neonatal Research Network;multidisciplinary;National Institute of Child Health and Human Development;Neonatal;Network Infrastructure;Newborn Infant;operation;participant safety;Process;Productivity;Publications;Qualifying;randomized trial;Reproducibility;Research;Research Design;Research Personnel;Resources;Role;Running;Safety;Standardization;Statistical Methods;Structure;System;tool;Training;Treatment Efficacy;trial design

PROJECT_TITLE: Neonatal Research Network Data Coordinating Center (DCC) 2023-2028


ED_INST_TYPE: SCHOOLS OF PUBLIC HEALTH

NIH_SPENDING_CATS: Cancer;Clinical Research;Clinical Trials and Supportive Activities;Colorectal Cancer;Complementary and Integrative Health;Dietary Supplements;Digestive Diseases;Immunotherapy;Liver Disease;Microbiome;Nutrition

ORG_CITY: BOSTON

ORG_NAME: HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH

ORG_STATE: MA

PHR: PROJECT NARRATIVE This project seeks to characterize the prebiotic and immune mechanisms underlying the benefits of eicosapentaenoic acid (EPA) for improving post-operative survival of patients with colorectal cancer liver metastasis (CRCLM) by leveraging the recently launched, randomized placebo-controlled phase III trial of EPA treatment in patients undergoing liver resection surgery for CRCLM. We will also address causality and mechanism with dietary and microbial interventions in a novel ‘avatar’ germ-free CRCLM mouse model which is ‘humanized’ with stool from trial participants. Based on these unique resources and our experienced transdisciplinary team, the proposed research will provide unprecedented insight into the prebiotic and tumor immunomodulatory effect of EPA to improve the prognosis and response to surgical resection of CRCLM, offering compelling translational evidence for novel dietary and microbial strategies for CRCLM treatment.

PI_NAMEs: GARRETT, WENDY S. (contact);HULL, MARK A

PROGRAM_OFFICER_NAME: HOWCROFT, THOMAS K

PROJECT_TERMS: Address;adenoma;Aftercare;Anti-Inflammatory Agents;anti-tumor immune response;Bacteria;beneficial microorganism;Bifidobacterium;biobank;Biological Markers;Blood;Blood specimen;Cancer Etiology;cancer immunotherapy;cancer survival;Cessation of life;chemokine;Chronic;Clinical;cohort;colon cancer patients;Colorectal Adenoma;Colorectal Cancer;colorectal cancer progression;colorectal cancer treatment;Colorectal Surgery;combinatorial;cost;CTLA4 gene;Data;density;Diet;dietary;Dietary Fats;dietary supplements;Dinoprostone;Dose;Eicosapentaenoic Acid;Escherichia coli;Esters;Etiology;Excision;experience;fecal transplantation;Feces;follow-up;Food;Frequencies;Funding;Fusobacterium nucleatum;Germ-Free;Gnotobiotic;Growth;gut bacteria;gut microbiota;host-microbe interactions;Human;Human Microbiome;Immune;immune checkpoint;immunoregulation;Immunosuppression;improved;improved outcome;Inflammation;Inflammation Mediators;Inflammatory;insight;Intervention;Investigation;Lactobacillus;Ligands;Lipopolysaccharides;Liver;marine;Mediating;Metabolic;Metastatic Neoplasm to the Liver;Microbe;microbial;microbiome;microbiome research;microbiota;Morbidity - disease rate;mouse model;Mus;Myeloid-derived suppressor cells;Neoplasm Metastasis;new therapeutic target;novel;Omega-3 Fatty Acids;Operative Surgical Procedures;Outcome;Participant;Pathway interactions;Patient Recruitments;patient subsets;Patient-Focused Outcomes;Patients;permissiveness;Phase;phase III trial;Placebo Control;Plasma;Postoperative Period;prebiotics;predicting response;predictive marker;Probiotics;Production;Prognosis;programmed cell death protein 1;Progression-Free Survivals;Property;prospective;Randomized;randomized placebo controlled trial;Regional Cancer;Regulatory T-Lymphocyte;Research;Resources;responders and non-responders;response;Role;Safety;Specimen;Standardization;stool sample;Structure;Supplementation;System;systemic inflammatory response;Testing;Tissues;Transplant Recipients;tumor;Tumor Burden;Tumor Escape;tumor growth;Tumor Immunity;tumor microenvironment;tumorigenic;urinary;Urine

PROJECT_TITLE: Prebiotic effect of eicosapentaenoic acid treatment for colorectal cancer livermetastasis

STUDY_SECTION: CPSS

STUDY_SECTION_NAME: Cancer Prevention Study Section[CPSS]


NIH_SPENDING_CATS: Arthritis;Autoimmune Disease;Infectious Diseases;Lyme Disease;Tickborne Diseases;Vector-Borne Diseases

ORG_CITY: CHICAGO

ORG_NAME: NORTHWESTERN UNIVERSITY AT CHICAGO

PHR: NARRATIVE Many patients who have been diagnosed with Lyme disease experience chronic symptoms despite having undergone extensive antibiotic therapy and appear to no longer have an active infection. The lead investigator of this proposal discovered that 1) the disease-causing agent sheds a component of its' cell-wall into its environment; 2) this molecule can be detected in patients' months after antibiotic treatment; and 3) the cell-wall, alone, is capable of causing disease pathology. In this project, we will determine what about the cell-wall makes patients sick and define strategies to improve Lyme disease patient health when antibacterial therapies have failed.

PI_NAMEs: JUTRAS, BRANDON LYON (contact)

PROGRAM_OFFICER_NAME: BOWDEN, NADINE

PROJECT_TERMS: Acute;Affect;Affective;Aftercare;American;Anatomy;Animal Experiments;Animals;Anti-Bacterial Agents;Antibiotic Therapy;Antibiotics;Antigens;Arthritis;Automobile Driving;Bacteria;Biopolymers;Borrelia;Borrelia burgdorferi;Cardiac;Cell Wall;Cells;Chemicals;Chemistry;Chronic;Clinical;Comparative Study;Coupled;Data;Diagnosis;Disease;Environment;Etiology;experience;flu;Genetic;genetic approach;Growth;Health;Human;human pathogen;immunoregulation;Impairment;improved;in vivo;Incidence;Infection;Inflammation;insight;Integration Host Factors;Intravenous;Isotope Labeling;Knowledge;Label;Lead;lens;Lyme Arthritis;Lyme Disease;lyme pathogenesis;Mammals;Methods;Molecular;Monoclonal Antibodies;Monoclonal Antibody Therapy;mouse genetics;mouse model;Mouse Strains;Mus;mutant;Nature;neuromusculoskeletal;nonhuman primate;Oral;Organ;pathogen;Pathogenesis;pathogenic bacteria;Pathogenicity;Pathology;Patients;Peptidoglycan;persistent symptom;Phase;Planets;Play;Polymers;Predisposition;Reporting;Research Personnel;response;reverse genetics;Role;Sampling;Severities;Symptoms;Synovial Fluid;System;Techniques;Therapeutic;Ticks;Time;Tissues;Toxin;Vector-transmitted infectious disease;Virulence Factors

PROJECT_TITLE: The natural release of unusual peptidoglycan fragments drives persistent Lyme disease symptoms in susceptible hosts