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

ORG_CITY: ATLANTA

ORG_DEPT: ANATOMY/CELL BIOLOGY

ORG_NAME: EMORY UNIVERSITY

PHR: Project Narrative: Over 150 million people are projected to be living with dementia worldwide by 2050, a threefold increase from today. Alzheimer’s disease represents the vast majority of these cases. Findings from this proposal will allow us to develop technologies to uncover the emergence of cellular and circuit dysfunction in early Alzheimer’s, and could lead to the development of novel molecular and cellular therapies that halt the disease.

PI_NAMEs: FOREST, CRAIG ;ROWAN, MATTHEW J.M. (contact)

PROGRAM_OFFICER_NAME: DIBATTISTA, AMANDA

PROJECT_TERMS: Acceleration;Action Potentials;Acute;Address;Affect;Age;Alzheimer's Disease;Alzheimer's disease brain;Alzheimer's disease diagnosis;Alzheimer's disease model;Alzheimer's disease patient;Amyloid Proteins;Animal Model;apolipoprotein E-4;Area;Biochemical Markers;Biological Markers;Brain;Brain region;Cell Therapy;cell type;Cells;Clinical Research;Cognition;commercialization;Data Set;Dementia;Deposition;Detection;Development;Diagnostic tests;Disease;effective therapy;Electrophysiology (science);Engineering;entorhinal cortex;Epilepsy;epileptiform;Evolution;excitatory neuron;familial Alzheimer disease;Fluorescence;fluorescence imaging;forest;Functional disorder;Future;Goals;Hippocampus;Human;Impaired cognition;in vivo;Individual;Interneurons;Label;Learning;machine vision;Memory;Memory Loss;Methods;mild cognitive impairment;Modeling;Molecular;mouse model;Mus;Neocortex;Nerve Degeneration;Neurobiology;Neurofibrillary Tangles;neuronal circuitry;Neurons;Neurosciences;neurotransmission;novel;operation;Optics;optogenetics;Parvalbumins;patch clamp;Pathologic;Pathology;Persons;Physiological;Physiology;pre-clinical;prevent;progressive neurodegeneration;Property;Research Personnel;Resolution;robotic system;Robotics;Science;Senile Plaques;Slice;Sorbus;success;Symptoms;tau Proteins;Technology;theories;Therapeutic;Time;tool;tool development;Work

PROJECT_TITLE: Automated cell-type specific electrophysiology for understanding circuit dysregulation in Alzheimer's Disease


ADMINISTERING_IC: AA

ARRA_FUNDED: N

ED_INST_TYPE: SCHOOLS OF MEDICINE

FUNDING_MECHANISM: OTHER RESEARCH-RELATED

IC_NAME: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Prevention;Social Determinants of Health;Substance Misuse;Substance Misuse Prevention;Violence Research

ORG_CITY: SEATTLE

ORG_COUNTRY: UNITED STATES

ORG_DEPT: PSYCHIATRY

ORG_FIPS: US

ORG_NAME: UNIVERSITY OF WASHINGTON

ORG_STATE: WA

PHR: PROJECT NARRATIVE Rate of HIV infection among U.S. military personnel has doubled in the past two decades, yet no HIV prevention interventions targeting this population have been tested in over a decade, and research on active- duty men who have sex with men (AD-MSM), who account for over 80% of new infections, was forbidden by federal policy for the first three decades of the HIV/AIDS crisis. HIV prevention interventions targeting AD-MSM should focus on alcohol-related sexual risk behavior (AR-SRB) given the high prevalence of heavy drinking within the population, the significant link between heavy drinking and sexual risk behavior, and barriers within the military health system that substantially limit pre-exposure prophylaxis as a viable prevention strategy for AD-MSM. The present study seeks to significantly expand our understanding of alcohol use and sexual risk behaviors within the notably understudied population of AD-MSM and to develop, then pilot test, an internet- based personalized feedback intervention motivating self-directed change in both heavy drinking and sexual HIV-risk behaviors among AD-MSM.

PI_NAMEs: WALTON, THOMAS OTTO (contact)

PROGRAM_OFFICER_NAME: FREEMAN, ROBERT

PROJECT_TERMS: active duty;Address;Affect;Afghanistan;AIDS prevention;Alcohol consumption;alcohol misuse;alcohol prevention;alcohol risk;alcohol use disorder;Alcohols;Award;Awareness;Behavior;behavior change;behavior prediction;Behavioral;behavioral health;behavioral response;Classification;Data;Development;Discrimination;drinking;Exposure to;federal policy;Feedback;Heavy Drinking;High Prevalence;high risk sexual behavior;HIV;HIV Infections;HIV risk;HIV/AIDS;Infection;infection rate;Internet;Intervention;intervention effect;Interview;Iraq;Lifting;Link;Literature;male;male health;Measures;Medical;medical specialties;men;men who have sex with men;Mentors;Methods;military health system;Military Personnel;military service;Modality;Modeling;National Institute on Alcohol Abuse and Alcoholism;Nature;novel;Occupational;Occupations;Participant;Pathway interactions;peer;Phase;phase 2 study;pilot test;Play;Policies;Population;pre-exposure prophylaxis;prevent;Prevention;Prevention strategy;preventive intervention;Privatization;Probability;Productivity;Provider;psychosocial;Randomized;Randomized, Controlled Trials;Recording of previous events;recruit;Research;Research Methodology;Research Personnel;Research Project Grants;Respondent;Risk;Risk Behaviors;Risk Factors;Risk Taking;Role;same sex behavior;Same-sex;Scholarship;Scientist;Self Direction;service member;sex;Sex Behavior;Sex Orientation;sexual assault;Sexual Harassment;sexual identity;sexual risk behavior;sexual trauma;sexual violence;social;social norm;social stigma;Stigmatization;Structure;success;Surveys;Target Populations;Testing;therapy development;Training;transmission process;Trauma;traumatic stress;Waiting Lists;War

PROJECT_TITLE: Understanding and preventing heavy drinking and related HIV-risk behavior among active-duty men who have sex with men

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 F17B-K (20)]


ADMINISTERING_IC: MH

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Dissemination and Implementation Research;HIV/AIDS;Health Services;Infectious Diseases;Mental Health;Pediatric;Pediatric - AIDS;Prevention;Women's Health Research

PHR: PROJECT NARRATIVE We will test the impact of a streamlined HIV testing (HTS) counselor-led care as an efficient and scalable strategy to take multi-product PrEP delivery to scale. We hypothesize that PrEP delivery can be done by HTS providers, in a single HIV testing encounter, in a way that will be more time-efficient and client-centered than current PrEP delivery pathway and will be acceptable, scalable, sustainable, and be readily transferable to other African settings.

PI_NAMEs: KINUTHIA, JOHN ;MUGWANYA, KENNETH KIGGUNDU (contact)

PROGRAM_OFFICER_NAME: POLLARD-BRANCHARD, SUZANNE LEE

PROJECT_TERMS: Acceleration;Acquired Immunodeficiency Syndrome;Adherence;Africa;African;Behavior;care seeking;Caring;Characteristics;Client;Clinic;Clinic Visits;Clinical;clinical development;Cluster randomized trial;Collaborations;Communities;Complement;Complex;Consolidated Framework for Implementation Research;Contraceptive methods;cost;County;Dapivirine;Data;design;Effectiveness;effectiveness evaluation;Effectiveness of Interventions;effectiveness testing;Eligibility Determination;Family Planning;Feasibility Studies;Focus Groups;General Population;Health;Health care facility;Health system;Human immunodeficiency virus test;implementation determinants;implementation strategy;Income;Individual;Infrastructure;Injectable;Injections;interest;Intervention;Interview;Kenya;Knowledge;Learning;meetings;Methods;Modeling;Monitor;Motivation;Needles;novel;Nurses;opportunity cost;Oral;Outcome;Pathway interactions;pilot test;Population;Postnatal Care;pre-exposure prophylaxis;Professional counselor;programs;Provider;Public Health;Randomized;Research;Risk;Safety;Sampling;scale up;Science;screening;Services;sexually active;Social Behavior;supply chain;Surveys;System;Testing;Time;Training;Training Support;treatment as usual;uptake;Vaginal Ring;Visit;Woman;Work;Workload

PROJECT_TITLE: Scaling up for impact: HIV testing counselor-led pathway to accelerate PrEP delivery at scale

STUDY_SECTION: PPAH

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


ADMINISTERING_IC: CA

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Cancer;Cancer Genomics;Genetics;Human Genome;Nanotechnology;Precision Medicine

ORG_CITY: SAN DIEGO

ORG_NAME: ELECTRONIC BIOSCIENCES, INC.

ORG_STATE: CA

PHR: Project Narrative This project aims to pioneer a groundbreaking approach to nanopore-based sequencing that will enable the extensive repeat segments within genomic DNA to be assessed with ultra-high accuracy—a feat unattainable with existing sequencing technologies. Our novel pore-controlled sequencing methodology will significantly enhance the precision and reliability of identifying disease-specific variations within DNA repeats and enable the ability to correlate these changes diagnostics, prognostics, and therapy interventions. The development of this technology will not only fill a crucial gap in current genetic analysis capabilities but also propel the field of personalized medicine forward for more accurate, targeted, and effective cancer treatments.

PI_NAMEs: PETERSON, ERIC MAYO (contact)

PROGRAM_OFFICER_NAME: DJEMIL, SARRA

PROJECT_TERMS: 3D Print;Adopted;Architecture;Back;base;Benchmarking;Biological;Biological Assay;Biological Markers;Biological Sciences;cancer care;cancer genomics;cancer subtypes;cancer therapy;cancer type;Cells;ChIP-seq;Clinical;Colorectal;Compensation;Complex;Consensus Sequence;cost;CSF1R gene;Data;design;Diagnostic;diagnostic tool;Dinucleoside Phosphates;Dinucleotide Repeats;Disease;Disease Progression;DNA;DNA Sequence;DNA sequencing;Drops;Effectiveness;Electronics;Endometrial;Ensure;Enzymes;Evaluation;Exhibits;Failure;Future;Generations;genetic analysis;Genome;Genomic DNA;genomic variation;Genomics;Human Genome;Huntsman Cancer Institute at the University of Utah;Immunotherapy;improved;Individual;innovation;insertion/deletion mutation;instrumentation;Laboratories;Lead;Length;Letters;magnetic field;Magnetism;Malignant Neoplasms;Marketing;Measurement;Methodology;Methods;Microsatellite Instability;Microsatellite Repeats;molecular diagnostics;Motor;Mutation;nanopore;Nature;novel;novel strategies;Nucleotides;Oncogenic;Oncology;Outcome;particle;Pathology;patient prognosis;Performance;personalized medicine;Phase;Physician Executives;plasmid DNA;Polymerase;Positioning Attribute;precision oncology;Process;professor;prognostic;programs;Prostate;Qualitative Methods;Reader;Reading;Repetitive Sequence;Research;Research Personnel;Role;Sampling;scaffold;Screening for cancer;Sequence Analysis;single molecule;Single Nucleotide Polymorphism;Small Business Innovation Research Grant;Statistical Data Interpretation;Stretching;success;System;Techniques;Technology;technology development;Tetranucleotide Repeat;Therapeutic;Therapeutic Intervention;Validation;Variant;voltage

PROJECT_TITLE: Fourth-Generation Nanopore-Assisted Sequencing for Advanced Oncological Analyses

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-G (15)]


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Biotechnology;Clinical Research;Clinical Trials and Supportive Activities;HIV/AIDS;Immunization;Immunotherapy;Infectious Diseases;Prevention;Vaccine Related

ORG_CITY: BOSTON

ORG_NAME: BETH ISRAEL DEACONESS MEDICAL CENTER

ORG_STATE: MA

PHR: The latent viral reservoir represents the key barrier to cure HIV-1 infection. We propose the evaluation of a therapeutic Ad26/MVA vaccine with a TLR7 agonist and/or broadly neutralizing antibodies in ART-suppressed, HIV-1-infected humans. These regimens aim to induce potent and broad immune responses and to activate latent reservoir cells to render them susceptible to immune-based destruction.

PI_NAMEs: BAROUCH, DAN H. (contact);JUELG, BORIS DOMINIK

PROGRAM_OFFICER_NAME: JANCI, ELIZABETH WONDERLICH

PROJECT_TERMS: Active immunity;Acute;acute infection;Agonist;Animals;anti-viral efficacy;Antigens;Bioinformatics;Boston;CD4 Positive T Lymphocytes;cell growth;Cells;Chronic;Collaborations;Data;design;Epitopes;Evaluation;Follow-Up Studies;Goals;HIV vaccine;HIV-1;Human;Immune;immune activation;Immune response;immunogenic;immunogenicity;Immunologic Stimulation;Individual;Infection;Macaca mulatta;manufacture;mosaic;Nature;neutralizing antibody;Passive Immunity;Predisposition;prophylactic;Regimen;Safety;SIV;Testing;Thailand;Therapeutic;Therapeutic Effect;therapeutic vaccine;TLR7 gene;Vaccinated;Vaccine Clinical Trial;vaccine evaluation;Vaccine Therapy;vaccine trial;Vaccines;vector;Viral Load result;Viral reservoir;Virus Latency;Virus Replication

PROJECT_TITLE: Ad26 Based Therapeutic Vaccines for HIV


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Bioengineering;Clinical Research;Networking and Information Technology R&D (NITRD)

ORG_CITY: ELLICOTT CITY

ORG_NAME: LINSHOM MEDICAL INC

ORG_STATE: MD

PHR: LINSHOM MEDICAL, INC.: has exclusive access to the facilities and resources of Artep Inc. Artep has over 35 years’ experience developing embedded controllers and data acquisition and instrumentation systems. Our engineers have all of the tools necessary to design, develop and test electronics and software real time embedded systems. Those tools include electronic CAD, software IDE, Compilers, Linkers, downloaders, emulators for embedded development, laptop development systems, LabView based Bench Checkout Equipment, power supplies, oscilloscopes, electronic benches for prototype builds, cable fabrication, electronic test equipment and SOLIDWORKS for mechanical design. The tools and equipment also exist for testing and verifying the Linshom respiratory monitor verses calibrated ventilators, Capnographs, and ventilator calibrating equipment (PFC-3000 Flow Analyzer). Over the years the Artep team of scientists and engineers provided an array of products and services to NASA, the Naval Research Laboratory, the U.S. Air Force, Lawrence Livermore National Laboratory, Sandia and public universities around the country and abroad. Instruments designed by Artep have flown successfully on more than 15 launch vehicles and have been fielded in many laboratory experiments. Artep, Incorporated, has produced space flight instruments for satellites, space shuttles, sounding rockets and research laboratories for over 35 years. Artep specializes in supporting scientific projects ranging from small experiment groups to large-scale research institutions and the military. Artep will design, fabricate, test, and integrate our custom hardware. Artep provides complete support in all key project areas, including Software Design, Electrical Engineering Mechanical Engineering Materials Selection, Optical Design. Linshom/Artep has over 35 years’ experience developing embedded controllers and data acquisition and instrumentation systems. Our engineers have all the tools necessary to design, develop and test electronics and software real time embedded systems. Those tools include electronic CAD, software IDE, Compilers, Linkers, downloaders, emulators for embedded development, laptop development systems, LabView based Bench Checkout Equipment, power supplies, oscilloscopes, electronic benches for prototype builds, cable fabrication, electronic test equipment and SOLIDWORKS for mechanical design. The tools and equipment also exist for testing and verifying the Linshom respiratory monitor verses calibrated ventilators, Capnographs, and ventilator calibrating equipment (PFC-3000 Flow Analyzer). Over 3 decades, the Artep team of scientists and engineers provided an array of products and services to NASA, the Naval Research Laboratory, the U.S. Air Force, Lawrence Livermore National Laboratory, Sandia and public universities around the country and abroad. Instruments designed by Artep have flown successfully on more than 15 launch vehicles and have been fielded in many laboratory experiments. Artep, Incorporated, has produced space flight instruments for satellites, space shuttles, sounding rockets and research laboratories for over 35 years. Artep specializes in supporting scientific projects ranging from small experiment groups to large-scale research institutions and the military. Artep along with our industry partners can design, fabricate, test, and integrate our custom hardware. Inhouse Software CAPABILITIES – Real-Time Operating Systems (RTOS) – Custom instrument Control – Data Acquisition systems – End to End Testing and Verification – Custom GUIís – C, C++, Labview, Assembly Artep facilities include: - office space - Dedicated area for Software development - Electronic Design Tools and CAD - Printed Circuit Board (PCB) Design Tools and CAD - Flex PCB design tools and CAD - testing and integration lab

PI_NAMEs: FELDMAN, RONEN  (contact);HUGHEN, JAMES RICHARD

PROGRAM_OFFICER_NAME: SHENOY, SIDDHARTH KAUP

PROJECT_TERMS: Air;Area;Calibration;Cannulas;Code;commercialization;Computer software;Country;Custom;data acquisition;Dedications;design;Development;Electrical Engineering;Electronics;Engineering;Equipment;experience;experimental group;fabrication;Future;Health Personnel;Healthcare;Home;industry partner;innovation;Institution;instrument;instrumentation;Laboratories;laboratory experiment;Laboratory Research;laptop;Mechanics;Methods;Military Personnel;miniaturized sensor;Monitor;Morbidity - disease rate;mortality;Nose;Operating System;Optics;Patients;Phase;Power Sources;preempt;printed circuit board;prototype;Research;research and development;Resources;respiratory;response;Scientist;sensor;sensor technology;Services;Small Business Innovation Research Grant;Software Design;software development;sound;Space Flight;System;Systems Development;Testing;Time;tool;United States National Aeronautics and Space Administration;Universities;Ventilator

PROJECT_TITLE: Advanced Prediction of Emerging Respiratory Decline with the Linshom Continuous Predictive Respiratory Sensor (CPRS)

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


ED_INST_TYPE: SCHOOLS OF PUBLIC HEALTH

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Cost Effectiveness Research;Digestive Diseases;Dissemination and Implementation Research;HIV/AIDS;Health Services;Hepatitis;Hepatitis - C;Infectious Diseases;Liver Disease;Prevention;Primary Health Care

ORG_CITY: BALTIMORE

ORG_DEPT: PUBLIC HEALTH & PREV MEDICINE

ORG_NAME: JOHNS HOPKINS UNIVERSITY

PHR: 8. PROJECT NARRATIVE We will evaluate the individual and population-level impact of integration of HCV treatment with tailored support and HIV and harm reduction services among people who inject drugs (PWID) in India. We will also assess barriers and facilitators to implementation of this model. This study will serve as a model for improving HCV treatment outcomes among HIV infected and uninfected PWID in low-and-middle-income countries. !

PI_NAMEs: MEHTA, SHRUTI H (contact);SOLOMON, SUNIL SUHAS

PROGRAM_OFFICER_NAME: CRAWFORD, KEITH W

PROJECT_TERMS: AIDS prevention;Algorithms;Anti-viral Agents;antiretroviral therapy;Awareness;Chronic;Cities;Client;Clinic;Clinical Trials;Cluster randomized trial;Communities;community collaboration;condoms;cost effective;cost effectiveness;cost-effectiveness evaluation;Counseling;Cross-Sectional Studies;Data;Directly Observed Therapy;Drug usage;Effectiveness;efficacy evaluation;Ensure;Epidemic;Evaluation;evidence base;Failure;Future;General Population;Geographic Locations;Government;Harm Reduction;Health;Hepatitis C Antibodies;Hepatitis C co-infection;Hepatitis C Incidence;Hepatitis C Prevalence;Hepatitis C Therapy;Hepatitis C virus;HIV;HIV Infections;HIV/HCV;Human immunodeficiency virus test;implementation facilitation;implementation facilitators;implementation outcomes;improved;Incidence;India;Individual;individualized medicine;Infrastructure;Injecting drug user;integrated care;Intervention;low and middle-income countries;Medical;Methods;Modeling;mortality;Needle-Exchange Programs;novel;opioid agonist therapy;Oral;Outcome;Patient Triage;patient-level barriers;peer;person centered;Persons;Pharmaceutical Preparations;point of care testing;Population;Positioning Attribute;Prevalence;Prevention;prevention service;Preventive service;Private Sector;programs;provider-level barriers;Public Health;Public Sector;Randomized;Resources;response;Risk;Sampling;Self Administration;serosurvey;Services;Site;social stigma;synergism;system-level barriers;Target Populations;Testing;transmission process;treatment center;Treatment Failure;Treatment outcome;treatment services;Triage;Viral

PROJECT_TITLE: Integrating HCV services into HIV programs for PWID in India


ADMINISTERING_IC: AT

IC_NAME: NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH

NIH_SPENDING_CATS: Aging;Basic Behavioral and Social Science;Behavioral and Social Science;Brain Disorders;Clinical Research;Complementary and Integrative Health;Depression;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Machine Learning and Artificial Intelligence;Mental Health;Networking and Information Technology R&D (NITRD);Pediatric;Prevention;Primary Health Care;Social Determinants of Health

ORG_NAME: SOCIALRX INC

ORG_STATE: GA

PHR: Project Narrative We are in the midst of a mental health crisis in this country, exacerbated by a shortage of available behavioral health services and a lack of person-centered innovative options for closing disparities. The evidence is clear that engagement with arts and culture has positive mental health and community benefit, and our product offers integration of arts and culture-based social prescriptions into the US healthcare system to address unmet mental health needs. This technology will enable precise matching of personalized arts prescriptions to address unmet behavioral health needs among both young and older adults in the US, which will revolutionize mental health treatment engagement and improve health outcomes.

PI_NAMEs: BAILEY, LUCY  (contact)

PROGRAM_OFFICER_NAME: HORGUSLUOGLU, EMRIN U

PROJECT_TERMS: Acute;Address;Algorithms;Anxiety;Applications Grants;Artificial Intelligence;behavioral health;Benchmarking;care delivery;Caring;Categories;Characteristics;Communities;Community Health;community-centered;Contracts;cost;cost effective;Country;Data;Data Set;Databases;depressive symptoms;Deterioration;Development;Diagnosis;Disparity;Documentation;Dose;Effectiveness;Emergency department visit;Equity;Ethnic Origin;experience;Face;Feeling suicidal;Future;Goals;Health;Health Benefit;health care delivery;health disparity;health goals;Health Personnel;Health Promotion;Health Resources;Health Services;Healthcare;Healthcare Systems;High School Student;Human;Improve Access;improved;Individual;Industry;Inequity;innovation;Insurance Coverage;integrated care;interest;Loneliness;Machine Learning;Medicare/Medicaid;meetings;Mental Depression;Mental Health;Mental Health Services;Methods;Modeling;Movement;National Institute of Nursing Research;Natural Language Processing;older adult;Older Population;optical character recognition;Outcome;patient oriented;Patient Preferences;Patients;person centered;Personal Satisfaction;Persons;Pharmaceutical Preparations;Pharmacy facility;Phase;physical conditioning;precision medicine;preference;prevent;programs;Provider;psychiatric emergency;Public Health;Recommendation;Reporting;Research;Resources;Risk;service delivery;Services;social;social culture;social factors;social health determinants;social inclusion;Social Interaction;Social isolation;social space;social stigma;standard of care;structural determinants;Suggestion;System;Taste Perception;Technology;Testing;Therapeutic Intervention;therapy design;Transportation;unsupervised learning;uptake;Validation;whole health;Work;young adult;Youth

PROJECT_TITLE: Personalized arts prescriptions for behavioral health challenges in the US

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 SCIL-D (10)]


ADMINISTERING_IC: HD

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

NIH_SPENDING_CATS: Bioengineering;Clinical Research;Clinical Trials and Supportive Activities;Contraception/Reproduction;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Maternal Health;Maternal Morbidity and Mortality;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Preterm, Low Birth Weight and Health of the Newborn;Prevention;Social Determinants of Health;Topical Microbicides;Women's Health Research

ORG_CITY: CAMBRIDGE

ORG_NAME: VENOVA TECHNOLOGIES, INC.

PHR: PROJECT NARRATIVE Forty percent of pregnancies in the United States are unintended each year, leading to the increased risk of adverse outcomes for mothers and their babies, including low infant birth weight, premature birth, inadequate or delayed prenatal care, and maternal morbidity and mortality. Many women inconsistently use or discontinue use of their contraceptive method because of unwanted side effects associated with hormones and copper. Venova Technologies is developing a first-in-class, non-hormonal, non-metal, long-acting female barrier device to address user preferences and the unmet need for highly effective side-effect-free contraception.

PI_NAMEs: MAN, EMILY  (contact)

PROGRAM_OFFICER_NAME: ALLEN, CATHERINE LEIGH

PROJECT_TERMS: abortion;Address;Adolescent;Advanced Development;adverse outcome;Amenorrhea;Anatomic Models;Award;Biological Testing;biomaterial compatibility;Birth;birth control;Businesses;Cervical;Cervical Caps;Cervix Uteri;Clinical;Clinical Data;clinical practice;Clinical Research;Clinical Trials;commercialization;condoms;Conduct Clinical Trials;Contraceptive Agents;Contraceptive Devices;Contraceptive methods;Contract Services;Copper;Copper Intrauterine Devices;Data;design;Device Designs;Device or Instrument Development;Devices;Disproportionately impacts women;Dysmenorrhea;economic implication;Emotional;Endometrial;Endometrium;Environment;Failure;Family;Family Planning;FDA approved;Federal Government;Female;Female Contraceptive Devices;Fertilization;Financial Hardship;Foundations;Freezing;Funding;Future;Grant;Headache;health economics;Hemorrhage;High-Risk Pregnancy;Hormonal;Hormones;Human;human tissue;hypothalamic pituitary gonadal axis;Hysterectomy;improved;In Vitro;in vivo;Individual;Industry;Inflammatory Response;innovation;Interruption;Intrauterine Devices;iterative design;Legal patent;Low Birth Weight Infant;Low income;Marketing;maternal morbidity;Maternal Mortality;maternal outcome;Medical Device;Menstrual cycle;Menstrual fluid;Menstruation;Mentors;Metals;Method Acceptability;Methods;Minority;Mission;models and simulation;National Institute of Child Health and Human Development;Nausea;necrotic tissue;nonhuman primate;novel;Oral Contraceptives;Pain;parous;Patients;Persons;Phase;Physiological;Pilot Projects;preclinical study;preference;Pregnancy;Premature Birth;Prenatal care;pressure;programs;Property;Provider;Regulatory Affairs;Research;Research Personnel;Resort;Resources;Respiratory Diaphragm;Retrieval;Risk;Safety;Secure;Seminal;Services;side effect;Small Business Innovation Research Grant;Societies;socioeconomics;sperm cell;Spermatocidal Agents;Spontaneous abortion;State Government;Strategic Planning;success;System;Technology;Testing;Tissue Sample;Tissues;unintended pregnancy;United States;United States Dept. of Health and Human Services;United States National Institutes of Health;US State;Uterus;Vagina;vaginal microbiome;Woman;women of color;women's reproductive health;Work

PROJECT_TITLE: A novel, non-hormonal, long-acting female contraceptive device

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 EMS-S (10)]


NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Cardiovascular;Clinical Research;Clinical Trials and Supportive Activities;Health Services;Heart Disease;Networking and Information Technology R&D (NITRD);Patient Safety;Telehealth

ORG_CITY: EAST WINDSOR

ORG_NAME: NUCLEUSRX, INC.

ORG_STATE: NJ

PHR: Project Narrative Heart Failure (HF) is the second highest cause for disease-related hospitalization in the US (~1 million/year), and has a mortality rate of 42% within 5 years of initial diagnosis. With ~6.2 million patients in the US, and despite being considered preventable, many HF related hospitalizations among older adults and Medicare beneficiaries have the highest readmission rate among all conditions, so reduction of hospitalizations is now a national priority for Medicare. To help reduce these re-hospitalizations, in this project we will develop a virtual intervention tool to help healthcare providers monitor patient health and adjust medication dose in real-time.

PI_NAMEs: RAKHIT, ASHOK  (contact)

PROGRAM_OFFICER_NAME: SHIROMA, ERIC JITSUO

PROJECT_TERMS: Acute;acute care;Agreement;American Heart Association;Area;Asthma;beneficiary;Blood Pressure Monitors;Caregivers;Cellular Phone;Cessation of life;Chronic Care;Clinic;Clinical;Clinical assessments;Clinical Protocols;Clinical Trials;cloud based;cloud platform;Communication;comorbidity;Companions;computer design;Computer software;Consensus;cost effective;Custom;dashboard;Data Analyses;data dashboard;Database Management Systems;Databases;Death Rate;Dementia;design;Development;Devices;Diabetes Mellitus;Diagnosis;digital applications;Disease;Diuretics;Dose;economic impact;Effectiveness;effectiveness evaluation;Electronic Health Record;electronic health record system;Emergency Situation;Evaluation;experience;Feasibility Studies;feasibility trial;Feedback;follow-up;Goals;graphical user interface;group intervention;Guidelines;Health;Health Care Costs;health data;Health Insurance Portability and Accountability Act;Health Personnel;Health Status;Health system;health warning;Healthcare Systems;Heart failure;Home;Hospital Planning;hospital readmission;Hospitalization;Hospitals;Hour;Hypertension;implementation barriers;improved;innovation;interest;Intervention;Interview;Knowledge;Legal patent;Length of Stay;manufacture;Marketing;Medical;Medicare;medication compliance;Mental Depression;Methodology;mobile application;Monitor;mortality;Ohio;older adult;operation;Outpatients;Patient Discharge;Patient Monitoring;Patients;Pharmaceutical Preparations;Phase;phase 2 testing;Phase II Clinical Trials;pill;profiles in patients;prototype;Provider;readmission rates;Recommendation;remote intervention;remote monitoring;remote therapy;Research;research and development;research clinical testing;Running;satisfaction;Security;Small Business Innovation Research Grant;smartphone application;Specialist;Stress;System;Technology;Testing;therapy adherence;Time;timeline;Titrations;tool;treatment adherence;Treatment Failure;United States;University Hospitals;usability;virtual;virtual healthcare;virtual intervention;Visit;web app;web site;Weight;Work

PROJECT_TITLE: Development of a Virtual Health Care Platform to reduce emergency re-hospitalizations in Heart Failure Patients transitioning from hospital to home

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


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Behavioral and Social Science;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Drug Abuse (NIDA only);Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Recovery Support Services;Rehabilitation;Social Determinants of Health;Substance Misuse

ORG_CITY: Culver City

ORG_NAME: PINK CLOUD LLC

PHR: Project Narrative The use of 12-Step programs remains a staple for SUD/AUD treatment, with groups such as Narcotics Anonymous, Alcoholics Anonymous, and Crystal Meth Anonymous catering to individuals with different substance use needs. Recent studies indicate that mobile health modalities for 12-Step programs may assist in addressing disparities in the delivery of SUD/AUD treatment. This project will help to determine if Pink Cloud, a mobile app with the most comprehensive database of in-person and virtual 12-Step meetings and recovery tracking functions, can effectively enhance the outcomes of people following various treatment pathways, by contributing to an increase in days sober and a reduction in substance use problems.

PI_NAMEs: LABRIE, JOSEPH W.;VARUGHESE, JASON  (contact)

PROGRAM_OFFICER_NAME: FLOOD, MORRIS

PROJECT_TERMS: access disparities;Address;Adoption;Aftercare;alcohol misuse;alcohol use disorder;Alcoholics Anonymous;Artificial Intelligence;base;Behavior;biobehavior;Businesses;central database;Cessation of life;chatbot;Client;Clinical;Code;Collaborations;commercialization;comparison control;Comprehensive Health Care;Control Groups;Country;Data Collection;Databases;design;Development;diaries;digital;digital platform;Directories;Disease;Disparity;Drug Addiction;Economics;Effectiveness;efficacy evaluation;Equipment and supply inventories;Ethnic Origin;Evaluation;experience;Feedback;Fees;Future;Gender;global health;Health Personnel;improved;Individual;innovation;Inpatients;Insurance;Knowledge;Length;Link;Marketing;Mediating;Mediator;meetings;Methamphetamine;mHealth;Minority Groups;mobile application;Mobile Health Application;Modality;mortality;Narcotics Anonymous;Outcome;outpatient programs;Participant;Pathway interactions;peer;Persons;Phase;Prayers;Predictive Factor;primary outcome;Privacy;programs;Provider;Public Health;Race;Randomized;Randomized, Controlled Trials;Recording of previous events;Recovery;recruit;reduced substance use;relapse prevention;Reporting;Research;research clinical testing;Research Personnel;Resources;secondary outcome;Self Direction;self help;Services;sex;Sex Orientation;Small Business Innovation Research Grant;sobriety;social media;Social support;Structure;substance use;Substance Use Disorder;substance use treatment;Testing;Time;tool;treatment center;treatment disparity;treatment program;Universities;user-friendly;virtual;Work

PROJECT_TITLE: Digital Aftercare Assessed: An Evaluation of the Pink Cloud Application in Post-Treatment Substance Use Disorder Support.


ADMINISTERING_IC: FD

ED_INST_TYPE: SCHOOLS OF PHARMACY

IC_NAME: FOOD AND DRUG ADMINISTRATION

ORG_DEPT: PHARMACOLOGY

ORG_NAME: UNIVERSITY OF MARYLAND BALTIMORE

PHR: Narrative Statement We propose continuation of M-CERSI that fosters FDA-oriented research, as well as regulatory science information sharing opportunities. The Center's mission is to foster the development of regulatory science – the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. Activities leverage the close geographic proximity between University of Maryland and FDA's main campus.

PI_NAMEs: BENTLEY, WILLIAM E.;POLLI, JAMES E (contact)

PROGRAM_OFFICER_NAME: SEPULVEDA, KRISTIN

PROJECT_TITLE: University of Maryland Center of Excellence in Regulatory Science and Innovation


ADMINISTERING_IC: ES

IC_NAME: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

NIH_SPENDING_CATS: Bioengineering;Endocrine Disruptors;Estrogen;Foodborne Illness;Social Determinants of Health

ORG_CITY: SAN FRANCISCO

ORG_NAME: XCELLASSAY, INC.

PHR: The proposed ‘in-the-field’ EDC-Sensor Strip would be sufficiently inexpensive to expand chemically agnostic BioAssay monitoring to all 148,000 US public water districts and even to individual water consumers seeking to independently verify the safety of their tap or purchased water. As envisaged, a well-designed multi-protein EDC-Sensor Strip also can have far-reaching environmental impact by identifying the source of the ‘dirty’ water, which will also accelerate the determination of the chemical identities of health-harming contaminants. Once the pan-EDC platform is fully developed, validated and EPA-approved, the plug-and-play nature of the platform will allow expansion of the in-the-field Sensor Strip to proteins/chemical classes other than Nuclear Receptors/EDCs.

PI_NAMEs: SCHAUFELE, FRED J (contact)

PROGRAM_OFFICER_NAME: HENRY, HEATHER F

PROJECT_TERMS: Acceleration;Affect;Area;authority;Binding;Biological Assay;California;Cells;Cellular Phone;chemical binding;Chemicals;cofactor;contaminated water;cost;design;Detection;detection limit;detection method;detector;Development;Disadvantaged;Disinfectants;drinking water;Economics;Endocrine Disruptors;Environmental Impact;Equipment;field study;Frequencies;Future;Glucocorticoids;Health;Human;Human Resources;In Vitro;Individual;Infrastructure;Inorganic Chemicals;instrumentation;Investigation;Laboratories;laboratory experience;Letters;Ligand Binding;Ligand Binding Domain;Ligands;Measurement;Measures;Methods;microorganism;Monitor;Nature;Nuclear Receptors;Organic Chemicals;Phase;phase 1 study;Physiological;Pilot Projects;Play;pollutant;Positioning Attribute;Printing;Procedures;Progestins;programs;Proteins;Protocols documentation;Radioisotopes;receptor;Receptor Activation;Reproducibility;Resources;Safety;Sensitivity and Specificity;sensor;Shipping;Side;Small Business Innovation Research Grant;small molecule;social;Source;Specificity;Steroids;Surveys;test strip;Testing;Time;tool;Training;usability;Variant;Water;Water Pollutants;water sampling;Water Supply;water testing

PROJECT_TITLE: One-step, in-the-field detection of water contamination by unhealthy concentrations of Endocrine Disrupting Chemicals affecting Nuclear Receptors arrayed on a test strip

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-S (12)]


ADMINISTERING_IC: AG

ED_INST_TYPE: SCHOOLS OF NURSING

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Bioengineering;Brain Disorders;Clinical Research;Data Science;Dementia;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Neurodegenerative;Neurosciences;Prevention;Social Determinants of Health

ORG_CITY: GAINESVILLE

ORG_DEPT: OTHER HEALTH PROFESSIONS

ORG_NAME: UNIVERSITY OF FLORIDA

ORG_STATE: FL

PHR: Project Narrative The project proposes to examine disparities in the risk of dementia among older people with HIV (PWH) by leveraging large-scale real-world data linked with social determinants of health (SDoH) and build a prediction model for an early warning system (EWS) that identifies PWH at a high risk of dementia considered disparities. This is a major step toward addressing the evidence gaps related to dementia in PWH, enhancing the data capabilities of a cohort of older PWH with all-cause dementia created with multi-domain infrastructure including SDoH, and establishing a prototype EWS employing machine learning risk prediction models. Our innovative EWS as an AI-driven clinical decision support tool is relevant to public health as it can have a potentially significant impact on reducing disparities and promoting healthy longevity for older PWH.

PI_NAMEs: CHO, HWAYOUNG  (contact)

PROGRAM_OFFICER_NAME: GERALD, MELISSA S

PROJECT_TERMS: Address;Affect;Age;age related neurodegeneration;aged;Aging;AIDS dementia;Alabama;Alzheimer's Disease;Alzheimer's disease related dementia;antiretroviral therapy;Architecture;Artificial Intelligence;biobehavior;Black Populations;care providers;career;Caregivers;Caring;Characteristics;Chronic Disease;Clinical;clinical decision support;clinical diagnosis;Clinical Research;clinical risk;cohort;Cohort Studies;comorbidity;computable phenotypes;Data;Data Science;Data Set;Data Sources;Dedications;Dementia;dementia risk;design;Detection;detection platform;Development;Diagnosis;Diet;Disparity;disparity reduction;Early Diagnosis;Education;effective therapy;Effectiveness;Electronic Health Record;Ensure;ethnic minority;Exhibits;Face;Florida;Focus Groups;Food Access;Foundations;Funding;Future;General Population;Goals;high risk;Hispanic Populations;HIV;Individual;Infrastructure;innovation;interest;Intervention;Interview;Knowledge;Life;Link;Longevity;Machine Learning;machine learning model;machine learning prediction;Medicare claim;Medicare/Medicaid;Mentors;Methods;Mission;modifiable risk;Natural Language Processing;Neighborhoods;Nerve Degeneration;Nervous System Disorder;neuroAIDS;Neurologic;Older Population;Outcome;Patients;Persons;Pharmaceutical Preparations;Phase;phenotyping algorithm;Population;pre-clinical;predictive modeling;Primary Care;Process;Proliferating;prospective;prototype;Public Health;racial minority;Research;Resources;Rights;Risk;Risk Factors;risk prediction model;Sample Size;Scientist;Smoking;social cohesion;social health determinants;Specialist;Structure;success;support tools;Symptoms;System;tool;Training;usability;user centered design;Validation;Veterans;Work

PROJECT_TITLE: Disparities in Risk of Dementia among People Living with HIV using Real-World Data

STUDY_SECTION: AGCD

STUDY_SECTION_NAME: Career Development For Early Career Investigators Study Section [AGCD-2]


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Cancer;Genetics;Hematology;Immunotherapy;Infectious Diseases;Orphan Drug;Rare Diseases

ORG_CITY: NEW YORK

ORG_NAME: UBIQUITX, INC.

ORG_STATE: NY

PHR: Narrative UbiquiTx’s Phase I project will demonstrate the feasibility of the proteome-editing platform to enhance antigen presentation and drive increased immunosurveillance; this work will pave the way for a future Phase II application that will focus on in vivo validation of the ubiCLIPs, and the improved efficacy of a novel immunotherapy treatment. Collectively, this research will not only support UbiquiTx’s project concept, but also offer the possibility for the improved treatment of a number of currently “undruggable” conditions, and resulting in new therapies for a potentially wide range of diseases.

PI_NAMEs: CAMARGO, LUIZ MIGUEL QUINN (contact)

PROGRAM_OFFICER_NAME: MINNICOZZI, MICHAEL

PROJECT_TERMS: Acute Myelocytic Leukemia;Affect;Affinity;Antigen Presentation;Antigens;Artificial Intelligence;Avidity;Binding;cancer/testis antigen;Cell Line;Cell surface;Cells;Cytomegalovirus;Cytotoxic T-Lymphocytes;Data;design;Disease;Disease Surveillance;Down-Regulation;Engineering;Enzymes;Future;Head and Neck Cancer;Human Papillomavirus;Immune;immune resistance;Immune Targeting;Immunologic Surveillance;Immunotherapy;improved;In Vitro;in vivo;Infection;interest;leukemia;Ligands;Ligase;lipid nanoparticle;Major Histocompatibility Complex;Malignant neoplasm of cervix uteri;Malignant Neoplasms;Measures;Memorial Sloan-Kettering Cancer Center;Messenger RNA;Methylation;Modality;Modification;multicatalytic endopeptidase complex;neoplastic cell;novel;novel strategies;novel therapeutics;Oncogenic;pathogen;patient response;Peptides;Phase;Phosphorylation;Phosphotransferases;Play;Post-Translational Protein Processing;preferentially expressed antigen in melanoma;prevent;Process;programs;Proliferating;protein degradation;Protein Engineering;Proteins;Proteome;Research;Role;Solid;System;T cell therapy;T-Cell Receptor;T-Lymphocyte;Technology;Testing;Therapeutic;therapeutic target;Therapeutic Uses;transcription factor;Treatment Efficacy;Ubiquitin;ubiquitin isopeptidase;Ubiquitination;Up-Regulation;Vaccines;Validation;Viral;Virus;Work;WT1 gene

PROJECT_TITLE: Chimeric Ligands for Induced Proximity (CLIP) platform for targeted proteome editing and upregulation of antigen presentation

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 DCAI-D (10)]


ADMINISTERING_IC: GM

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Data Science;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD)

ORG_NAME: KOLIBER BIOSCIENCES, INC.

PHR: PUBLIC RELEVANCE The development of peptide therapeutics holds significant promise in addressing a wide range of medical conditions, from diabetes and obesity to cancer and pain management. By advancing research and technology in this field, we can unlock new avenues for more effective and affordable treatments, improving patient outcomes and transforming the landscape of modern medicine.

PI_NAMEs: LIS, EWA  (contact)

PROGRAM_OFFICER_NAME: KODURI, SAILAJA

PROJECT_TERMS: Address;Algorithms;Amino Acids;Artificial Intelligence;Biological Availability;Body Weight decreased;Case Study;Cells;Chemicals;clinical application;commercialization;complex data;Computer software;Cyclic Peptides;Cyclization;Data;data complexity;Data Engineering;Data Set;Databases;deep learning model;design;Development;Diabetes Mellitus;diverse data;drug discovery;empowerment;Foundations;glucagon-like peptide 1;glycemic control;Guidelines;Half-Life;improved;innovation;insight;Insulin;Laboratories;lead optimization;Legal patent;Life;Machine Learning;machine learning model;Malignant Neoplasms;Medical;Metabolism;Methodology;Methods;Modeling;Modern Medicine;Modernization;novel;Obesity;Online Systems;Oral;Pain management;Patient-Focused Outcomes;Patients;Penetration;peptide drug;Peptides;Performance;Permeability;Pharmaceutical Chemistry;Pharmaceutical Preparations;Phase;Process;Property;Publishing;Research;Research Personnel;Schedule;Secure;Solid;Solubility;Structure;success;synthetic peptide;Techniques;Technology;Tertiary Protein Structure;Testing;Therapeutic;timeline;tool;Toxic effect;Training;training data;unnatural amino acids;Work

PROJECT_TITLE: Artificial intelligence based platform for peptide lead optimization.

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MBBC-G (10)]


NIH_SPENDING_CATS: Aging;Clinical Research;Disability Research;Physical Activity

ORG_CITY: CHICAGO

ORG_NAME: ADAPTIVE TESTING TECHNOLOGIES

ORG_STATE: IL

PHR: PROJECT NARRATIVE Fatigue is a frequent symptom in hospitalized older adults, and acute illness can increase a patient’s fatigue at any given activity level (fatigability), inhibiting activity and functional recovery after hospital discharge. This proposal will develop and validate a Computerized Adaptive Test for Fatigability (CAT-F), which will allow for rapid and accurate measurement of fatigability as a multidimensional construct. The CAT-F will generate a new kind of data that will allow clinicians to improve the care of hospitalized older adults with fatigue, and will allow scientists to improve the efficiency of conducting studies and trials of interventions hospital discharge.

PI_NAMEs: COHEN, YEHUDA  (contact);PROCHASKA, MICAH THOMAS

PROGRAM_OFFICER_NAME: SERRA, MONICA CHRISTINE

PROJECT_TERMS: Acute;Address;Adverse effects;Calibration;Caring;Chicago;Clinical;clinical care;clinical decision-making;clinical practice;clinically relevant;commercialization;common symptom;comparative;computerized;Consent;cost;Cost Measures;Data;data integration;data warehouse;debilitating symptom;deconditioning;Deterioration;Development;Dimensions;disability;EHR research;electronic health record system;exercise capacity;Exercise Test;Exertion;experience;Fatigue;Feedback;frailty;functional decline;functional improvement;functional status;Future;Generations;Healthcare Systems;high risk;Hospitalization;Hospitals;improved;innovation;Inpatients;instrument;instrumental activity of daily living;Intervention;intervention effect;Intervention Trial;Measurement;Measures;Medical center;Methods;Modeling;Monitor;mortality;neglect;Odds Ratio;older adult;optimal treatments;Outcome;Pathway interactions;Patient Self-Report;Patients;Performance;Phase;point of care;prevent;Probability;Process;prognostic indicator;Quality of life;Recovery of Function;Research;response;Risk;Sampling;Science;Scientist;sedentary lifestyle;standard measure;Standardization;Statistical Methods;Symptoms;Technology;Testing;theories;Time Study;Translating;treadmill;Treadmill Tests;treatment strategy;Universities;Validation;Walking;web services;Work

PROJECT_TITLE: Development and Validation of a Computerized Adaptive Test of Fatigability


NIH_SPENDING_CATS: Bioengineering;Lung;Orphan Drug;Prevention;Pulmonary Fibrosis;Rare Diseases

ORG_CITY: NEWTON

ORG_NAME: MECHANOBIOLOGIX, LLC

PHR: Narrative Idiopathic pulmonary fibrosis is a rapidly progressing lung disease with no known cure. To enhance drug development approaches toward this need, we propose a human lung slice-based drug discovery assay that is focused directly on the physiological endpoint relevant to patient wellbeing, tissue stiffness. Our central hypothesis is that lung tissue stiffness is well-suited to evaluate both the therapeutic and preventative potential of candidate drugs.

PI_NAMEs: KIM, JAE HUN  (contact)

PROGRAM_OFFICER_NAME: GOMEZ, CHRISTIAN RENE

PROJECT_TERMS: Actins;Acute Respiratory Distress Syndrome;Affect;Alveolar;Alveolus;American;Architecture;Atomic Force Microscopy;Biological;Biological Assay;Biological Models;Biomechanics;Blood;cell behavior;Cells;Cessation of life;Characteristics;Collagen;Collagen Type III;commercialization;Consumption;cost;crosslink;cytokine;Data;Deposition;Development;Devices;Diagnosis;Disease Progression;drug candidate;drug development;drug discovery;empowerment;End Point Assay;Enzymes;Epigallocatechin Gallate;epithelial injury;Evaluation;Evolution;experimental study;extracellular;Failure;Fibrillar Collagen;Fibroblasts;follow-up;Human;idiopathic pulmonary fibrosis;improved;in vitro Model;Individual;Industry;innovative technologies;invention;Label;LOX gene;Lung;Lung Compliance;Lung Diseases;Malignant Breast Neoplasm;Malignant neoplasm of prostate;Maps;Measurement;Measures;Mechanics;Methods;Modeling;Molecular;Monitor;multiple omics;Mus;Myofibroblast;nintedanib;Pathway interactions;Patients;Perfusion;Personal Satisfaction;Pharmaceutical Preparations;Phase;Phase II Clinical Trials;Phosphotransferases;Physiological;Preventive;Production;Protein-Lysine 6-Oxidase;Pulmonary Fibrosis;Resolution;Sampling;Site;Slice;Smooth Muscle;spatiotemporal;statistics;Stretching;Structure;Structure of parenchyma of lung;Technology;Testing;Therapeutic;therapeutic evaluation;Time;Tissues;Transforming Growth Factors;Validation;ventilation;Work of Breathing

PROJECT_TITLE: Stiffness measurements in human lung slices to evaluate therapeutic and preventive potentials of anti-fibrotic drugs

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 RCCS-B (11)]


NIH_SPENDING_CATS: Lung;Orphan Drug;Pulmonary Hypertension;Rare Diseases

ORG_CITY: INDIANAPOLIS

ORG_NAME: VASCULONICS, LLC

ORG_STATE: IN

PHR: Project Narrative: Pulmonary arterial hypertension is a highly debilitating and fatal disease. Current therapies targeted to the mechanisms of vasodilation reduce the symptoms of the disease but do not significantly impact disease progression. The mortality of PAH patients remains high. Vasculonics is developing a novel medicine to reduce disease progression and improve survival of PAH patients.

PI_NAMEs: SINGH, JAIPAL  (contact)

PROGRAM_OFFICER_NAME: SUTLIFF, ROY L

PROJECT_TERMS: AHR gene;Animal Model;Animals;antagonist;Aryl Hydrocarbon Receptor;Biological Assay;Blood Vessels;Canis familiaris;Cardiac;Cell Proliferation;Chemicals;Clinical;clinical candidate;Clinical Research;Clinical Trials;Cyclic GMP;Data;Development;Dexfenfluramine;dimethylargininase;Disease;disease model;Disease Progression;Dose;drug candidate;drug development;Drug Kinetics;Drug Targeting;efficacy study;Ensure;Event;Exhibits;experience;Failure;Feasibility Studies;Fibrosis;Genes;Goals;Hepatocyte;Human;human model;Hypoxia;improved;In Vitro;in vivo;Inflammation;Inflammatory;innovation;Lead;lead optimization;Learning;Legal patent;manufacture;Marketing;Medical;Medicine;Metabolism;Modeling;Molecular;mortality;N,N-dimethylarginine;novel;novel drug class;novel therapeutics;Oral;Outcome Study;Oxidative Stress;Pathogenesis;Pathologic;Pathway interactions;Patients;Pharmaceutical Chemistry;Pharmaceutical Preparations;Phase;Play;potency testing;Pre-Clinical Model;pre-clinical research;preclinical efficacy;preclinical safety;preclinical study;Predisposition;programs;promoter;pulmonary arterial hypertension;pulmonary arterial pressure;Pulmonary artery structure;pulmonary vascular disorder;pulmonary vascular remodeling;Quality of life;Rattus;Receptor Activation;reduce symptoms;research clinical testing;response;Risk;Role;Safety;safety assessment;safety study;Scheme;Series;Small Business Innovation Research Grant;Smooth Muscle Myocytes;Structure-Activity Relationship;success;Survival Rate;targeted treatment;Testing;Therapeutic;Toxic effect;Toxicokinetics;Toxicology;Toxin;Vascular Diseases;Vasodilation;Vasodilator Agents

PROJECT_TITLE: Development of a novel disease modifying oral therapy for pulmonary arterial hypertension.


NIH_SPENDING_CATS: Genetics;Infectious Diseases;Neurosciences;Sexually Transmitted Infections

ORG_CITY: VESTAVIA HILLS

ORG_NAME: CALADAN THERAPEUTICS, INC.

ORG_STATE: AL

PHR: PROJECT NARRATIVE HSV-2 can have deep social and health consequences for the estimated 500 million infected individuals, yet current antiviral therapies can only reduce symptoms and disease severity, and do not cure. We have developed an innovative therapeutic strategy consisting of targeting and eliminating HSV genomes directly within viral reservoirs using gene editing meganucleases. Leveraging our strong, unique expertise in gene editing enzyme technology and HSV virology, Caladan Therapeutics and Fred Hutch propose to develop and advance an anti-HSV-2 gene therapy towards clinical applicability, offering a plausible pathway toward a cure for individuals infected with HSV-2.

PI_NAMEs: JEROME, KEITH R (contact)

PROGRAM_OFFICER_NAME: DUPUY, LESLEY CONRAD

PROJECT_TERMS: Acute;Acyclovir;Address;adenovirus mediated delivery;Adult;Aftercare;aged;American;Animal Model;Animals;Anti-viral Therapy;Biological Assay;Cancer Center;Cavia;Cellular Assay;Cessation of life;Chromosomal translocation;Clinical;clinical application;Communication;Control Animal;curative treatments;Death Rate;Dependovirus;Development;Disease;Engineering;Enzymes;Frequencies;Ganglia;gene editing technology;gene therapy;gene-editing approach;Genes;genital herpes;genital infection;Genitalia;Genome;Genomics;genotoxicity;Guinea;guinea pig model;Health;Hepatitis B Virus;Herpes Simplex Infections;Herpesvirus 1;Human;Human Herpesvirus 2;Human Papillomavirus;In Vitro;in vitro Assay;in vivo;in vivo evaluation;Individual;Infection;Infection Control;innovation;interest;Interruption;Lead;lead candidate;Lesion;Licensing;Liver;Mammalian Cell;Marketing;Mediating;Mental Health;Modeling;Morbidity - disease rate;mouse model;Mus;Mutagenesis;Nature;Neurons;neurotoxicity;orofacial;Pathogenesis;Pathway interactions;Patients;Peripheral;Peripheral Nervous System;Persons;Phase;pre-clinical;Protein Engineering;psychosocial;Randomized;Recurrence;Recurrent disease;reduce symptoms;Reporter;Safety;Series;Severities;Severity of illness;Sexual Health;Sexual Partners;Simplexvirus;Small Business Technology Transfer Research;social;Source;Specificity;success;Surface;System;Technology;Testing;Therapeutic;transmission process;Variant;viral DNA;Viral Genome;Viral Load result;Viral Physiology;Viral reservoir;virology;Virus Diseases;Virus Replication;Virus Shedding;Work;Writing;Yeasts

PROJECT_TITLE: Meganuclease-mediated gene editing for durable control of HSV-2 infection

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


ADMINISTERING_IC: OH

IC_NAME: NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH

ORG_NAME: CHARLES RIVER ANALYTICS, INC.

PHR: Project Narrative  Traditional training methods lack immersive hazard exposure simulations, hindering effective NIOSH hierarchy of controls (HoC) training. In IMPRINT NIOSH, Charles River Analytics will provide a portable, immersive, and intelligent virtual reality (VR) training system to support the personal protective equipment (PPE) and engineering controls education as part of HoC instruction within existing trainingorganizations and consortia. In Phase II, IMPRINT NIOSH will create an engaging and immersive virtual reality (VR) training system, including an intelligent virtual training companion, that enhances existing training, enables adaptive learning, and improves worker safety and adherence to OSHA standards.

PI_NAMEs: CROSS, ERNEST VINCENT (contact)

PROGRAM_OFFICER_NAME: CHIOU, SHARON

PROJECT_TITLE: Immersive Modular Preparedness Intelligent Tutor for the National Institute for Occupational Safety and Health (IMPRINT NIOSH)


ED_INST_TYPE: SCHOOLS OF ARTS AND SCIENCES

NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Clinical Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Lung;Mental Health;Neurosciences;Pediatric;Prevention;Racial and Ethnic Minority Health Research;Sleep Research;Social Determinants of Health

ORG_CITY: EUGENE

ORG_DEPT: PSYCHOLOGY

ORG_NAME: UNIVERSITY OF OREGON

ORG_STATE: OR

PHR: PROJECT NARRATIVE Sleep disordered breathing (SDB) and insufficient sleep are two highly prevalent sleep deficiencies in preschoolers that frequently co-occur, disproportionately affect non-Latinx Black compared to non-Latinx White youth, and negatively impact crucial neurobehavioral and social-emotional development. Modifiable family, childcare, and neighborhood factors that contribute to or buffer against these sleep health disparities and their developmental impacts are poorly understood. To address these gaps and inform effective interventions, the objectives of this research are to (1) examine racial disparities in the neurobehavioral and social-emotional impacts of SDB and/or insufficient sleep in non-Latinx Black and non-Latinx White preschoolers and (2) identify proximal and distal socio-ecological factors linked to these racial disparities in sleep-related outcomes.

PI_NAMEs: WILLIAMSON, ARIEL A (contact)

PROGRAM_OFFICER_NAME: BROWN, ALISON GWENDOLYN MARY

PROJECT_TERMS: 5 year old;actigraphy;Address;adverse outcome;Affect;African American;Age;Asthma;Attention;Belief;Black Populations;Black race;Brain;Buffers;caregiver stress;Caregivers;Categories;Characteristics;Child;Child Care;Child Rearing;Childhood;Data;Development;Disparity;disparity reduction;Distal;early childhood;Education;effective intervention;Electronics;emotion regulation;Emotional;emotional functioning;Employment Status;Environment;environmental tobacco smoke;ethnic minority;executive function;experience;Exposure to;Family;Goals;Green space;Guidelines;Health behavior;health disparity;health equity promotion;health literacy;Hour;Household;Impairment;Incidence;Income;informant;innovation;Intervention;lead exposure;Link;Mediating;Methods;minority children;neighborhood safety;Neighborhoods;neurobehavioral;Obesity;Obstructive Sleep Apnea;Outcome;peer;physical conditioning;Policies;Poverty;Prevalence;primary caregiver;Qualitative Methods;Quality of Care;Quality of life;Race;racial bias;racial disparity;racial minority;racism;recruit;Reporter;Reporting;Research;resilience;Risk;Schedule;Sleep;Sleep Apnea Syndromes;Sleep Deprivation;sleep health;Snoring;social;social skills;socioeconomic disparity;Stress;Structural Racism;Symptoms;teacher;Toxin;vigilance;walkability;Work;Youth

PROJECT_TITLE: Socio-ecological factors linked to co-occurring early childhood sleep health disparities and developmental outcomes

STUDY_SECTION: MESH

STUDY_SECTION_NAME: Biobehavioral Mechanisms of Emotion, Stress and Health Study Section[MESH]


ED_INST_TYPE: EARTH SCIENCES/RESOURCES

NIH_SPENDING_CATS: Behavioral and Social Science;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Drug Abuse (NIDA only);HIV/AIDS;Harm Reduction for Substance Misuse;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Prevention;Social Determinants of Health;Substance Misuse;Telehealth

ORG_CITY: STORRS-MANSFIELD

ORG_NAME: UNIVERSITY OF CONNECTICUT STORRS

ORG_STATE: CT

PHR: NARRATIVE  Chemsex, the use of psychoactive drugs before or during sexual activity, is a growing public health concern associated with striking increases in HIV, particularly among men who have sex with men (MSM). This study proposes to optimize an app-based just-in-time adaptive intervention, called JomCare, which aims to reduce chemsex risk by delivering tailored support when a person is most likely to be vulnerable to chemsex risk behaviors and receptive to intervention, with the purpose of reducing risk and averting new HIV infections.

PI_NAMEs: SHRESTHA, ROMAN  (contact);WICKERSHAM, JEFFREY ALLEN

PROGRAM_OFFICER_NAME: JENKINS, RICHARD A

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;adaptive intervention;addiction;Address;AIDS prevention;Area;Asia;Behavior;Behavioral;Cellular Phone;Communication;Counseling;Ecological momentary assessment;Epidemic;Event;Evidence based intervention;Experimental Designs;Face;Funding;Guidelines;habituation;Harm Reduction;HIV;HIV Infections;HIV/AIDS;HIV/STD;improved;innovation;innovative technologies;interest;Intervention;Knowledge;Location;machine learning algorithm;Malaysia;Malaysian;marginalized population;men who have sex with men;Mental disorders;mHealth;mhealth interventions;Modeling;Monitor;Motivation;multiphase optimization strategy;Nature;Needle-Exchange Programs;Obesity;Outcome;Output;Participant;personalized intervention;Persons;physical inactivity;pre-exposure prophylaxis;Prevalence;Prevention strategy;Prophylactic treatment;Psychotropic Drugs;Public Health;Randomized;randomized trial;Research;Research Priority;response;Risk;Risk Behaviors;Risk Reduction;service delivery;Services;Sex Behavior;Sexual Partners;skills;smartphone application;Stigmatization;syndemic;Technology;Testing;theories;Time;transmission process;United States National Institutes of Health;uptake;willingness;Work

PROJECT_TITLE: Optimizing a Just-in-Time Adaptive Intervention to Increase Uptake of Chemsex Harm Reduction Services in MSM: A Micro-randomized Trial

STUDY_SECTION: HIBI

STUDY_SECTION_NAME: HIV/AIDS Intra- and Inter-personal Determinants and Behavioral Interventions Study Section[HIBI]


ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

NIH_SPENDING_CATS: Back Pain;Bioengineering;Chronic Pain;Neck Pain;Neurosciences;Pain Research

ORG_CITY: DALLAS

ORG_NAME: BACKSTOP NEURAL, INC.

ORG_STATE: TX

PHR: Project Narrative Spinal cord stimulation (SCS) is an effective treatment for chronic, intractable pain, but it is not used often to target the cervical spinal cord for arm and neck pain, in part because the leads are not well suited. Percutaneous leads have higher rates of migration, a key issue when considering electrode placement in the neck, while thicker (2 mm) surgical paddle leads are difficult to insert in the narrow cervical epidural space. To address the challenges of cervical SCS for chronic arm and neck pain, BackStop Neural proposes an epidural paddle lead that is 10× thinner than commercially available leads, stiff enough for established surgical implantation techniques, and able to soften and conform to the spinal cord after insertion for positional stability.

PI_NAMEs: MANZ, CONNIE  (contact)

PROGRAM_OFFICER_NAME: CAPORELLO, EMILY LAURA

PROJECT_TERMS: Acceleration;Address;Adult;Affect;Animals;Arm Pain;Back;biomaterial compatibility;Cadaver;capsule;Cervical;Cervical spinal cord structure;Cervical spine;Charge;Chest;Chronic;chronic back pain;chronic pain;commercialization;Complex Regional Pain Syndromes;cytotoxicity;Data;design;Diabetic Neuralgia;Dryness;effective therapy;electric impedance;electrical property;Electrodes;Ensure;epidural space;Ethylene Oxide;Euthanasia;fabrication;FDA approved;Film;Future;Grant;Hemolysis;Histopathology;Human;Image;Implant;implantation;improved;in vivo;Inflammation;Injections;innovation;Intractable Pain;Lead;Limb structure;Low Back Pain;manufacturing process;materials science;Measurement;Mechanics;Microfabrication;migration;Modulus;Molecular Conformation;National Institute of Neurological Disorders and Stroke;Neck;Neck Pain;neural;Neurostimulation procedures of spinal cord tissue;novel;Operative Surgical Procedures;Outcome;Pain in lower limb;pain reduction;Pattern;Periodicity;Phase;Physiologic pulse;Polymer Chemistry;Polymers;Property;Rattus;Research;Resistance;Risk;Rodent;Running;Safety;scale up;seal;Sheep;Site;Small Business Innovation Research Grant;Spectrum Analysis;Spinal Cord;success;Syndrome;System;systemic toxicity;Techniques;Testing;Thick;Thinness;Vertebral column;Visual;years lived with disability

PROJECT_TITLE: Thin, Softening Epidural Leads for Chronic Arm and Neck Pain

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


NIH_SPENDING_CATS: Infectious Diseases;Lung;Orphan Drug;Rare Diseases

ORG_CITY: Irvine

ORG_NAME: SCIENTIFIC HORIZONS CONSULTING LLC

PHR: Project Narrative Non-tuberculous mycobacterial (NTM) lung disease represents a major public health challenge, with long treatment period and high-dose systemic administration often leading to adverse effects, resistance development, and suboptimal therapeutic outcomes. Here, we propose a novel antibiotic delivery system, cyclodextrin-based metal-organic frameworks (CD-MOFs), to form antibiotic/CD-MOF cocrystals administered through an inhalation route via a dry powder inhaler (DPI) to tackle the challenges in NTM infection treatments. Because of the unique value of CD-MOF cocrystals provided (i.e., minimized systemic exposure and adverse effects, improved bioavailability, synergistic effect, controlled release, intracellular internalization targeting, lower production cost, etc.), our proposal could potentially offer multiple benefits to the field of pulmonary antibiotic delivery for the improved efficacy and safety in treating NTM lung infections.

PI_NAMEs: GAO, XIANG  (contact)

PROGRAM_OFFICER_NAME: BOYCE, JIM P

PROJECT_TERMS: 3-Dimensional;absorption;Adverse effects;Adverse event;Air;Alveolar;Alveolar Macrophages;Antibiotics;antimicrobial;Antimycobacterial Agents;Apical;Biological Availability;Cell Survival;Coculture Techniques;controlled release;cost;Cyclodextrins;cytokine;dosage;Dose;Drug Delivery Systems;drug inhalation;Dryness;Encapsulated;follow-up;Future;Gene Expression;Goals;Human;improved;In Vitro;Infection;Inflammatory;Inhalation;Inhalators;innovation;insight;Interferon Type II;Investigation;Knockout Mice;Lung;Lung Diseases;Lung infections;Macrophage;Metals;Methods;Modeling;monocyte;mouse model;mycobacterial;Mycobacterium abscessus;Mycobacterium avium;non-tuberculosis mycobacteria;non-tuberculous mycobacterial infection;novel;novel therapeutics;Patients;Performance;Permeability;pharmacokinetics and pharmacodynamics;Phase;pneumocyte;Powder dose form;Production;Public Health;rational design;Recurrent disease;Refractory Disease;Resistance development;respiratory;Route;Safety;Site;Small Business Innovation Research Grant;Solvents;Surface;System;Therapeutic;therapy outcome;tissue culture;Tissues;Toxic effect;treatment duration

PROJECT_TITLE: Pulmonary Delivery of Antibiotics Co-crystalized with Cyclodextrin-based Metal Organic Frameworks to Treat Non-Tuberculous Mycobacterial (NTM) Infections


NIH_SPENDING_CATS: Bioengineering;Climate-Related Exposures and Conditions;Foodborne Illness;Prevention

ORG_CITY: AUSTIN

ORG_NAME: MATERIALS NOVA LIMITED LIABILITY COMPANY

PHR: PROJECT NARRATIVE (RELEVANCE) Climate change is expected to lead to increased frequency and severity of global weather disasters. High- density population areas often experience significant disruptions in essential supplies, including water, during these events, making rescue operations extremely challenging. This project aims to create an innovative, point-of-use (POU) water purification solution for individuals and homes via fabricating and exploiting a unique highly-branched graphite foam and designed high-frequency electric fields to directly fish out bacteria and remove toxic metal ions in natural water sources, enabling scalable applications from personal cups to emergency water storage.

PI_NAMEs: LI, HUIFENG  (contact)

PROJECT_TITLE: Innovative Point-of-Use Water Purification System: Portable, Scalable, Efficient, Easy-Use


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Clinical Research;Emerging Infectious Diseases;HIV/AIDS;Infectious Diseases;Lung;Rare Diseases;Tuberculosis

ORG_CITY: BIRMINGHAM

ORG_DEPT: MICROBIOLOGY/IMMUN/VIROLOGY

ORG_NAME: UNIVERSITY OF ALABAMA AT BIRMINGHAM

PHR: PROJECT NARRATIVE Despite decades of tuberculosis (TB) research, few studies have focused on the fundamental mechanisms of active, subclinical, and latent human TB, which is largely due to a lack of human TB lung tissue for study. Thus, the goal of this R24 proposal is to transform the global TB research landscape by accelerating the study of human TB lung tissue. We will accomplish this by providing valuable analytical services and/or human TB lung tissues to the TB research community, thereby allowing TB investigators worldwide to challenge, and likely change, existing paradigms of the cellular and pathological basis of human TB to improve diagnosis, prevention, and treatment of TB.

PI_NAMEs: STEYN, ADRIE JC (contact)

PROGRAM_OFFICER_NAME: RADKE, JOSHUA BRYAN

PROJECT_TERMS: Acceleration;Alabama;Anatomy;Animal Model;Animals;Antibiotics;Autopsy;Basic Science;Biological Models;Cessation of life;Childhood;Clinical;clinical development;Clinical Investigator;Clinical Research;clinically relevant;Collection;Communities;community engagement;Data;Dedications;Diagnosis;Diagnostic;digital;Discipline;Disease;Drug or chemical Tissue Distribution;Flow Cytometry;Forensic Pathology;Funding;genetic analysis;Goals;Health Sciences;HIV;HIV Seronegativity;HIV/TB;Human;Human Resources;human subject;Immunofluorescence Immunologic;improved;innovation;Institution;interest;International;Internet;Knowledge;Laboratories;laser capture microdissection;Lesion;Lobe;Lung;Mediating;Messenger RNA;microCT;Mycobacterium tuberculosis;Mycobacterium tuberculosis antigens;new technology;Pathologic;Pathology;Patients;Persons;Prevention;Prevention Measures;Publishing;Pulmonary Tuberculosis;R24;repository;Research;Research Personnel;Resected;Resources;Review Committee;Sampling;Scanning;service delivery;Services;Shipping;Slide;South Africa;Specimen;Structure;Structure of parenchyma of lung;Texas;Therapeutic;Three-dimensional analysis;Tissue Banks;Tissue Sample;Tissue Stains;Tissues;transcriptomics;translational impact;Translational Research;transmission process;Tuberculosis;tuberculosis drugs;tuberculosis treatment;Universities;Vaccines;virtual;Visualization;web site;X-Ray Medical Imaging

PROJECT_TITLE: A Global Research Resource for Human Tuberculosis

STUDY_SECTION_NAME: Special Emphasis Panel[ZAI1 BJM-A (M1)]


NIH_SPENDING_CATS: Bioengineering;Brain Cancer;Brain Disorders;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Neurosciences;Orphan Drug;Rare Diseases

ORG_CITY: LOUISVILLE

ORG_NAME: CREOSALUS, INC.

ORG_STATE: KY

PHR: Narrative  Many of the primary and metastatic brain tumor subtypes present enormously complex diagnosis and therapy challenges with dismal outcomes that have not changed for several decades. The proposed research is for combining two drug delivery technologies that have demonstrated feasibility into an innovative commercial system and then evaluated for a first time in a clinical study for improved brain tumor drug delivery.

PI_NAMEs: ABRAMOV, VASILIY  (contact)

PROGRAM_OFFICER_NAME: LI, MELISSA WANLING

PROJECT_TERMS: Acceleration;Acute;Adoption;Adverse event;Biopsy;Brain;Brain Diseases;Brain Neoplasms;cancer therapy;Catheters;Chronic;Clinical;Clinical Research;Clinical Trials;commercial application;commercialization;comparative;comparison control;Complex;Computer software;Convection;Data;design;Devices;Diagnosis;Drug Delivery Systems;drug distribution;Evaluation;Family suidae;FDA approved;first-in-human;Future;Glioblastoma;Glioma;Hospitals;Human;human study;improved;in vivo;Infusion procedures;Injury;innovation;Institutional Review Boards;Intervention;Joints;Letters;Magnetic Resonance Imaging;Malignant Glioma;manufacture;Manufacturer;Marketing;Medical Device;Methods;Molecular;molecular imaging;neuro-oncology;Neurosurgeon;neurosurgery;novel strategies;Outcome;Patient-Focused Outcomes;Patients;Pharmaceutical Preparations;Phase;Physicians;Porosity;Positron-Emission Tomography;pre-clinical;pre-clinical research;Procedures;Product Approvals;Protocols documentation;provider adoption;Qualifying;Randomized;randomized, controlled study;Randomized, Controlled Trials;Readiness;Recurrence;Research;Research Personnel;Safety;Sales;Sample Size;Serum Albumin;simulation;simulation software;Small Business Innovation Research Grant;Study Section;System;Technology;Testing;Therapeutic;Therapeutic Agents;Time;Tracer;Training;tumor;Tumor Subtype;Tumor Volume

PROJECT_TITLE: Comparison of convection enhanced delivery systems in a randomized controlled clinical study of recurrent Grade 3-4 glioma patients

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CTH-T (10)]


NIH_SPENDING_CATS: Genetics;Neurodegenerative

ORG_CITY: LA JOLLA

ORG_NAME: UNIVERSITY OF CALIFORNIA, SAN DIEGO

PHR: Project Narrative Uncorrupted gene expression is critical to cell function and human health. Our cells encode a multitude of RNA quality control machineries that detect and degrade defective RNAs that have the potential to interrupt gene expression, some of which have been linked to neurodegenerative disorders. The objective of this proposal is to uncover the mechanisms whereby these pathways detect and degrade defective RNAs in human cells, and the consequences of defects in these pathways to cell function and human health.

PI_NAMEs: LYKKE-ANDERSEN, JENS  (contact)

PROGRAM_OFFICER_NAME: VATAKIS, DIMITRIOS NIKOLAOS

PROJECT_TERMS: 7SL RNA;Address;Biological Assay;Cell Physiology;Cells;Code;Defect;Failure;Gene Expression;Genetic Transcription;Goals;Health;Human;human disease;Human Genome;insight;Interruption;Learning;Link;Mediating;Messenger RNA;Monitor;mRNA Decay;Mutagenesis;Neurodegenerative Disorders;Pathway interactions;Play;Predisposition;Proteins;Pseudogenes;Quality Control;Research;RNA;RNA Processing;Role;Signal Recognition Particle;Small Nuclear RNA;Spliceosomes;Untranslated RNA;Variant

PROJECT_TITLE: Mechanisms of human RNA turnover and quality control

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


ED_INST_TYPE: GRADUATE SCHOOLS

FUNDING_MECHANISM: TRAINING, INDIVIDUAL

NIH_SPENDING_CATS: HIV/AIDS;Infectious Diseases;Prevention;Stem Cell Research;Stem Cell Research - Nonembryonic - Human

ORG_CITY: CAMBRIDGE

ORG_DEPT: CHEMISTRY

ORG_NAME: HARVARD UNIVERSITY

PHR: PROJECT NARRATIVE: HIV infects human blood cells via the CD4 receptor and one of two co-receptors: CCR5 or CXCR4. Utilizing gene editing tools on human blood stem cells to target CCR5 and CXCR4 can generate HIV resistant human blood stem cells. These modified cells could serve as a potential new treatment option for HIV patients.

PI_NAMEs: JOUBRAN, SAMANTHA  (contact)

PROGRAM_OFFICER_NAME: LAWRENCE, DIANE M

PROJECT_TERMS: Address;Adenine;antiretroviral therapy;Area;base editing;base editor;Binding;Biology;Blood Cells;Boston;CCR5 gene;CD4 Antigens;CD4 Positive T Lymphocytes;Cell surface;Cells;Cessation of life;Communication;comorbidity;Complement;CRISPR/Cas technology;CXCR;CXCR4 gene;Data;Development;Disease;DNA sequencing;Drug Interactions;Drug Side Effects;Drug usage;experience;Faculty;Fluorescence-Activated Cell Sorting;gene editing technology;gene-editing approach;genome editing;Glycoproteins;Goals;Health;Hematopoiesis;Hematopoietic;Hematopoietic stem cells;HIV;HIV Envelope Protein gp120;HIV Infections;HIV Receptors;HIV resistance;HIV-1;Human;Impairment;Individual;Infection prevention;Knock-out;Ligands;Membrane Proteins;Mentors;Methods;Migration Assay;molecular dynamics;mutant;Mutation;Nucleotides;Oral;Patients;Pediatric Hospitals;Persons;Play;prevent;Production;protein function;Protein Truncation;receptor;receptor function;Research;Resistance;Resources;Role;Running;Screening Result;side effect;skills;Stromal Cell-Derived Factor 1;Surface;Testing;tool;Training;Universities;Virus;Virus Diseases;Work;Writing

PROJECT_TITLE: Developing HIV Resistant Hematopoietic Stem Cells through Targeted Base Editing

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 F17A-G (20)]


NIH_SPENDING_CATS: Bioengineering;Chronic Pain;Opioids;Pain Research;Patient Safety

ORG_NAME: MEDICAL ELUTION DEVICES LLC

PHR: Narrative: Chest tubes drainage devices are commonly used in clinical practice for the removal of accumulated fluid or air in the pleural space between the lungs and chest wall, and are implanted via the intercostal space (between the ribs) and extend into the pleural cavity. Consequently, these devices cause intense pain in patients that necessitates the use of systemic opioid painkillers. This work will complete drug release, stability, and manufacturability studies for a novel chest tube that releases local non-opioid painkillers, reducing or removing the need for the opioid treatments.

PI_NAMEs: BAKER, AARON BLAIR;STROMBERG, DANIEL  (contact)

PROGRAM_OFFICER_NAME: LIU, SONGTAO

PROJECT_TERMS: Acceleration;addiction;addiction liability;Air;Analgesics;Anesthetics;Anti-Inflammatory Agents;Breathing;Bupivacaine;Cardiac Surgery procedures;Caring;Chest;Chest Tubes;Chest wall structure;Clinical;clinical practice;Collection;cost;Dangerousness;Dependence;Devices;Discipline of Nursing;Dose;Drainage procedure;Drug Delivery Systems;drug release kinetics;Drug Stability;drug testing;Excision;Goals;Health Care Costs;Hospitals;Human;Hypotension;Implant;implantation;In Vitro;intense pain;irritation;Kinetics;Legal patent;Length;Life;Liquid substance;Local Anesthetics;Lung;manufacturability;manufacture;Mechanics;Medical Device;Membrane;Minor;Modeling;Movement;Mucous Membrane;Narcotics;Nausea and Vomiting;non-opioid analgesic;novel;novel therapeutics;Operative Surgical Procedures;Opioid;Opioid Analgesics;opioid use;Pain;Pain management;pain reduction;Patients;Pericardial body location;Pharmaceutical Preparations;Physicians;Pleural;Pleural cavity;Polymers;Porosity;Postoperative Period;preclinical development;Preclinical Testing;prescription opioid;prototype;Quality Control;Recovery;Research Project Grants;Respiration;rib bone structure;Risk;Sedation procedure;Severities;side effect;simulation;Site;Speed;Sterilization;Structure;Suction;Surgeon;Surveys;Techniques;Technology;Testing;Thoracic Injuries;Thoracic Surgical Procedures;thrombotic;Time;Training;translational goal;Trauma;Tube;Urinary Retention;usability;Ventilatory Depression;virtual surgery;Work

PROJECT_TITLE: Chest Tube with Sustained Release of Local Anesthetic Agents for Pain Reduction in Cardiothoracic Surgeries


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Biotechnology;Brain Disorders;Complementary and Integrative Health;Dementia;Dietary Supplements;Digestive Diseases;Microbiome;Neurodegenerative;Neurosciences;Nutrition

ORG_CITY: SAN DIEGO

ORG_NAME: BLOOM SCIENCE, INC.

PHR: NARRATIVE Alzheimer’s disease (AD) is the most common neurodegenerative disease, that has few therapeutics that treat its underlying causes. The gut-brain axis presents exciting opportunities to develop novel therapeutics for AD through reducing systemic inflammation and the concentration of gut-derived toxic metabolites that contribute to disease progression. This project aims to engineer the next-generation probiotic Akkermansia muciniphila to produce anti-inflammatory molecules to treat Alzheimer’s disease.

PI_NAMEs: MIANO, ARIANNA  (contact)

PROGRAM_OFFICER_NAME: MARTIN, ZANE

PROJECT_TERMS: 3xTg-AD mouse;Abeta synthesis;Address;Affect;Alzheimer's Disease;Alzheimer's disease model;Alzheimer's disease pathology;Alzheimer's disease patient;Alzheimer's disease therapeutic;Amines;Anti-Inflammatory Agents;Bacteria;beta-Hydroxybutyrate;Bile Acids;Biological Assay;Biological Response Modifier Therapy;Brain;Butyrates;Central Nervous System;Cerebrospinal Fluid;Choline;Circulation;Clustered Regularly Interspaced Short Palindromic Repeats;Cognition;Collection;cytokine;Data;Deterioration;Disease;disease phenotype;Disease Progression;dysbiosis;efficacy testing;efficacy validation;Engineered Probiotics;Engineering;Escherichia coli;Gene Combinations;Genetic;Genetic Engineering;Genome;Grant;gut inflammation;gut microbes;gut microbiota;gut-brain axis;Histone Deacetylase Inhibitor;Human;in vivo;in vivo Model;Inflammation;Inflammatory;innovation;intestinal barrier;ketogenic diet;Ketone Bodies;Libraries;Liver;Marketing;Measures;Mediating;Memory;Metabolic Pathway;microbial community;microbiome;microbiome therapeutics;Microglia;mild cognitive impairment;mouse model;Mucins;Mus;Nerve Degeneration;Neurodegenerative Disorders;neuroinflammation;neuroprotection;next generation;novel;novel therapeutic intervention;novel therapeutics;Oxides;Pathogenesis;Pathology;Pathway interactions;Patients;Permeability;Persons;Pharmaceutical Preparations;Phase;phase 2 study;Physiological;Play;pre-clinical;Probiotics;Production;Property;reduce symptoms;Regulatory Element;Safety;screening;Senile Plaques;Site;Symptoms;systemic inflammatory response;tau aggregation;tauroursodeoxycholic acid;Testing;Therapeutic;tool;Volatile Fatty Acids

PROJECT_TITLE: Neuroprotective Engineered Bacteria for Alzheimer's Disease Treatment

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


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging

ORG_CITY: JERSEY CITY

ORG_NAME: ENDOLYNX INC

PHR: Project Narrative Over 30 million intubations are performed in the US each year and improper endotracheal tube (ETT) placement and insufficient ETT monitoring result in patient injury causing ~$12B in unnecessary costs each year in the US. Endolynx is developing an optical sensor-enabled endotracheal tube (ETT) allowing both proper initial positioning and continuous positional monitoring of OS-ETT, which will substantially reduce the risk and incidence of esophageal intubation and unintended extubation.

PI_NAMEs: JACHIMOWICZ, FELEK  (contact)

PROGRAM_OFFICER_NAME: SHENOY, SIDDHARTH KAUP

PROJECT_TERMS: Algorithms;anatomic imaging;Auscultation;biomaterial compatibility;Bronchoscopy;Cadaver;Calibration;Capnography;Clinical Research;cost;cost effective;Data;data visualization;design;endotracheal;Enhancement Technology;Ensure;Esophagus;Family suidae;first-in-human;Future;Gases;Health;Iatrogenesis;Image;image processing;Incidence;Injury;Intubation;Laryngoscopes;Life;Location;Measurement;Medical;Medical emergency;Methods;Modification;Monitor;Morbidity - disease rate;mortality;Movement;Noise;optical sensor;Patients;Phase;porcine model;Positioning Attribute;Preparation;remote monitoring;respiratory;Risk Reduction;Roentgen Rays;sample fixation;signal processing;Signal Transduction;Small Business Innovation Research Grant;sound;Sterilization;Support System;System;Techniques;Technology;Testing;Thoracic Radiography;Time;Trachea;transmission process;Tube;Validation;Visual;Visualization;vocal cord;X-Ray Computed Tomography

PROJECT_TITLE: Optical sensor-enabled endotracheal tube to reduce esophageal intubation and unintended extubation

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-S (11)]


NIH_SPENDING_CATS: Attention Deficit Hyperactivity Disorder (ADHD);Behavioral and Social Science;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Mental Health;Networking and Information Technology R&D (NITRD);Neurosciences;Pediatric;Prevention;Rehabilitation

ORG_CITY: SAN FRANCISCO

ORG_NAME: NEUROTRAINER INC

PHR: Narrative Our project introduces NeuroTrainer (NT), a novel virtual reality (VR) cognitive training system—which uniquely combines immersive VR technology with physical activity to enhance cognitive functions like attention and executive control, addressing both ADHD symptoms and related academic impairments—to address the challenges of ADHD, which affects about 11% of children and adolescents. This intervention aligns with NIMH goals by offering an engaging, adaptive, and personalized approach, aiming to improve real-world functional outcomes in educational settings. Our research aims to demonstrate NT's effectiveness in enhancing cognitive and academic performance, potentially transforming ADHD intervention methods and contributing to better mental health outcomes.

PI_NAMEs: NYQUIST, JEFF  (contact);SCHWEITZER, JULIE B.

PROGRAM_OFFICER_NAME: GRABB, MARGARET CHRISTINE

PROJECT_TERMS: Address;Adherence;Adolescent;Affect;Athletic;Attention;Attention deficit hyperactivity disorder;attentional control;Behavior;Cessation of life;Child;Clinical;Cognitive;cognitive ability;cognitive benefits;cognitive enhancement;cognitive function;cognitive skill;cognitive training;compare effectiveness;Computers;Control Groups;cost;Data;design;Development;Diagnosis;digital health;Dimensions;Education;Educational Intervention;effective intervention;Effectiveness;efficacy evaluation;efficacy study;Environment;Evaluation;executive function;Exhibits;Feasibility Studies;follow-up;functional improvement;functional outcomes;Funding;Goals;health goals;Hyperactivity;Impairment;improved;Impulsivity;inattention;Individual;innovation;Intervention;Link;Measures;Mental disorders;Mental Health;Methods;Motivation;multimodality;National Institute of Mental Health;neural;Neurodevelopmental Disorder;novel;Outcome;Outcome Measure;Performance;personalized approach;personalized intervention;Physical activity;Play;Population;Population Heterogeneity;premature;primary outcome;Psychological Transfer;Research;Research Domain Criteria;Resources;Risk;Sampling;School Drop-Outs;Schools;Short-Term Memory;skills;Sorting;Student Dropouts;student participation;Students;Substance abuse problem;success;Symptoms;System;Technology;Testing;tool;traditional therapy;Training;Training Programs;Underachievement;United States National Institutes of Health;virtual reality;virtual reality environment;virtual reality intervention;visual search;Work;Youth

PROJECT_TITLE: A Feasibility and Efficacy Study of NeuroTrainer Cognitive Training in Students With and Without Attention-Related Difficulties

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


NIH_SPENDING_CATS: Biotechnology;Genetics;HIV/AIDS;Human Fetal Tissue;Infectious Diseases

ORG_NAME: J. DAVID GLADSTONE INSTITUTES

PHR: PROJECT NARRATIVE HIV persists despite antiretroviral therapy in part because CD4+ T cells persistently infected with the virus can replicate themselves in a process called homeostatic proliferation. In this proposal, we set out the determine the outcome of targeting infected cells responding to IL7 – a key mediator of homeostatic proliferation – on HIV persistence, using both in vitro and in vivo models. Our study combines measurements of HIV persistence with in-depth characterization of the features of persistently-infected cells that are susceptible vs. resistant to our therapy, in order to shed light on the multiple mechanisms HIV exploits to persist in long-lived, self-renewing host cells.

PI_NAMEs: ABDEL MOHSEN, MOHAMED ;ROAN, NADIA R (contact)

PROGRAM_OFFICER_NAME: ZHOU, YAN

PROJECT_TERMS: antagonist;Antibodies;antibody-dependent cell cytotoxicity;antibody-dependent cellular phagocytosis;anticancer activity;antiretroviral therapy;Automobile Driving;Binding;BLT mice;Bone Marrow;cancer therapy;Categories;CD4 Positive T Lymphocytes;Cell model;Cells;Cellular Indexing of Transcriptomes and Epitopes by Sequencing;Chronic;Clinic;Clinical Trials;Clonal Expansion;comparison control;cytokine;cytotoxicity;Data;Disease remission;DNA;DNA Integration;Failure;follow-up;Gene Expression;Gene Expression Profiling;Genetic Transcription;HIV;HIV Infections;Human;humanized mouse;IL7 gene;IL7R gene;Immune;immune reconstitution;Immune system;Immunologics;In Vitro;in vivo;in vivo Model;Infection;Inflammation;innate immune function;Institutional Review Boards;Interleukin 7 Receptor;Interleukin-15;Interruption;Intervention;intervention effect;latent infection;Leukemic Cell;Liver;Maintenance;manufacture;Measurement;Mediating;Mediator;Memory;memory CD4 T lymphocyte;Modeling;Monitor;Monoclonal Antibodies;mouse model;multiple omics;Mus;Myeloid Cells;Natural Killer Cells;novel;novel strategies;Outcome;Patients;Persons;Plasma;Predisposition;Process;Productivity;Proliferating;reconstitution;Resistance;response;RNA;RNA Splicing;Role;Safety;self-renewal;Signal Transduction;single cell sequencing;single-cell RNA sequencing;Site;T memory cell;T-Lymphocyte;Testing;therapeutic target;Therapy trial;Thymus Gland;Time;Tissue Model;Tissues;Tonsil;Transcript;Translations;Viral;viral rebound;Virus;Virus Replication

PROJECT_TITLE: Targeting CD127-expressing tissue reservoir cells as a strategy for HIV cure

STUDY_SECTION: HVCD

STUDY_SECTION_NAME: HIV Molecular Virology, Cell Biology, and Drug Development Study Section[HVCD]


NIH_SPENDING_CATS: Assistive Technology;Bioengineering;Cardiovascular;Congenital Heart Disease;Congenital Structural Anomalies;Heart Disease;Patient Safety;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Rare Diseases

ORG_CITY: San Diego

ORG_NAME: STARLIGHT CARDIOVASCULAR, INC.

PHR: PROJECT NARRATIVE One percent of babies are born each year with Congenital Heart Disease (CHD), and these babies often require surgical intervention to survive. However, the devices that are currently used to treat this pediatric population were designed for adult cardiovascular conditions and do not always perform as intended in babies. Starlight Cardiovascular aims to solve this problem by developing a portfolio of devices for CHD, starting with what will be the first FDA-approved ductus arteriosus stent, which has the potential to save lives and increase access to less invasive treatments for babies born with CHD.

PI_NAMEs: TANG, BEVERLY  (contact)

PROGRAM_OFFICER_NAME: BURNS, KRISTIN

PROJECT_TERMS: Address;Adult;Anatomy;Animals;Aorta;Birth;Boston;Cardiovascular system;Case Report Form;Catheters;Childhood;Chronic;Circulation;Clinical;clinical trial protocol;Clinical Trials;Collaborations;commercialization;commercialization readiness;congenital heart abnormality;Congenital Heart Defects;Consent Forms;Coronary artery;Data;design;Development;Device Designs;Device or Instrument Development;Devices;Disease;Distal;Documentation;Duct (organ) structure;Ductus Arteriosus;Ensure;experience;Face;FDA approved;Feasibility Studies;Financial Support;first-in-human;flexibility;Funding;Good Manufacturing Process;improved;In Situ;in vivo evaluation;innovation;Intervention;Legal patent;Length of Stay;manufacture;manufacturing process;Mechanics;Medical Device;minimally invasive;Monitor;Morbidity - disease rate;mortality;mortality risk;neonate;Newborn Infant;novel;operation;Operative Surgical Procedures;Outcome;Patients;Pediatric Hospitals;Phase;Physicians;Population;Preclinical Testing;Preparation;Procedures;Process;Prostaglandins;Pulmonary artery structure;Qualifying;Quality Control;research clinical testing;Risk;Safety;screening;Secure;Series;Shunt Device;Small Business Innovation Research Grant;Stents;Surgeon;System;Technology;Testing;Thoracic Surgical Procedures;tool;Trauma;United States;Validation;Vendor;verification and validation

PROJECT_TITLE: Commercialization Readiness for Ductus Arteriosus Stent to Improve Congenital Heart Defect Mortality

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-B (19)]


ADMINISTERING_IC: AR

IC_NAME: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

NIH_SPENDING_CATS: Arthritis;Bioengineering;Brain Disorders;Chronic Pain;Complementary and Integrative Health;Neurosciences;Opioid Misuse and Addiction;Opioids;Osteoarthritis;Pain Research;Rehabilitation;Substance Misuse

ORG_CITY: Cambridge

ORG_NAME: BRIXTON BIOSCIENCES, INC.

PHR: Project Narrative Using opioids for severe osteoarthritis (OA) in the knee for pain control can lead to opioid use disorder (OUD). We are developing a platform technology, Coolio™ using Neural Ice™ that has the potential to reduce pain for up to 8 weeks. Our goal, focusing initially on OA in the knee, is to develop an affordable, easy-to-use, effective treatment for pain that directly aligns with NIH’s HEAL Initiative, advancing heath equity in meaningful way.

PI_NAMEs: SIDOTI, CHARLES  (contact)

PROGRAM_OFFICER_NAME: WANG, XIBIN

PROJECT_TERMS: addiction;Address;Adopted;Adult;Adverse event;Analgesics;Anatomy;Area;Arthralgia;Biological;Biological Sciences;biomaterial compatibility;Bolus Infusion;Breakthrough device;Capital;Certification;Cicatrix;Clinic;Clinical;Clinical Data;cold temperature;Consumption;cost;Degenerative polyarthritis;design;Development;Devices;Diffuse;Documentation;Economic Burden;effective therapy;Effectiveness;efficacy trial;Ensure;fascinate;FDA approved;Feasibility Studies;feasibility trial;Freezing;Funding;Goals;Grant;Health;Health care facility;health equity;Helping to End Addiction Long-term;Human;Ice;improved;in vivo evaluation;Inflammation;Injectable;Injections;Intervention;invention;Knee;Knee Osteoarthritis;knee pain;knee replacement arthroplasty;Lead;Letters;Liquid substance;manufacturability;manufacture;meetings;Methods;Modeling;Muscle;Natural regeneration;Needles;Nerve;Nerve Block;neural;neurotransmission;non-opioid analgesic;Nonpharmacologic Therapy;novel;Opiate Addiction;Opioid;opioid epidemic;opioid sparing;opioid use;opioid use disorder;Orthopedic Surgery;Outcome;Pain;Pain management;Pain Management Method;pain patient;pain reduction;pain relief;pain score;pain sensation;patient population;Patients;Performance;Perioperative;Peripheral Nerves;Persistent pain;Pharmaceutical Preparations;Phase;Pilot Projects;point of care;Postoperative Pain;pre-clinical;Preparation;prescription opioid;Privatization;Procedures;Process;Public Health;Qualifying;Rattus;Reporting;response;Rheumatoid Arthritis;Risk Management;Safety;Sensory;Serious Adverse Event;Skin Tissue;Sleep;Small Business Technology Transfer Research;Specialist;Sterility;Structure;Surgeon;Syringes;System;Technology;technology platform;Temperature;Testing;Time;Tissues;Translations;Tube;United States National Institutes of Health;Validation;Vendor;Wallerian Degeneration;Water;Work

PROJECT_TITLE: Neural Ice Technology for Treatment of Pain


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Cardiovascular;Clinical Research;Data Science;Health Services;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Prevention

ORG_CITY: EVANSTON

ORG_NAME: THIRD COAST DYNAMICS, INC.

PHR: PROJECT NARRATIVE The goal of this proposal is to develop a cloud-based artificial intelligence-based platform that will provide 4D hemodynamic output directly from widely available routine clinical and easy-to-obtain anatomic images of the chest. The technology will enable improved and personalized risk-stratification of complications in patients with aortic disease beyond the current simple and insufficient clinical measures. In addition, the technique can improve operational efficiencies and reduced health care utilization costs for a wide range of patients and healthcare providers without the need for highly specialized imaging equipment, training, and expertise.

PI_NAMEs: ALLEN, BRADLEY DAVID (contact)

PROGRAM_OFFICER_NAME: FARAHANI, KEYVAN

PROJECT_TERMS: 4D MRI;Academic Medical Centers;Acceleration;Address;Agreement;analysis pipeline;anatomic imaging;Anatomy;Angiography;Aorta;Aortic Diseases;Artificial Intelligence;Biological Markers;Chest imaging;Clinical;clinical implementation;clinical translation;cloud based;cohort;Collaborations;commercialization;commercialization readiness;Computer software;Computerized Medical Record;Consumption;cost;Coupled;Data;data warehouse;Databases;Dedications;deep learning;deep neural network;design;Development;Diameter;digital health;Dilatation - action;Dimensions;Disease;Dissection;Early Diagnosis;Equipment;Evaluation;experience;follow-up;Foundations;Generations;Goals;Growth;health care service utilization;health care settings;Health Personnel;hemodynamics;high risk;Image;implementation study;improved;improved outcome;in vivo;Infrastructure;innovative technologies;Intuition;Label;Liquid substance;loss of function;Magnetic Resonance Imaging;Maps;Marketing;Measurement;Measures;Medicare;Modeling;Monitor;network architecture;Outcome;outcome prediction;Outcome Study;Output;Patient Monitoring;Patient-Focused Outcomes;Patients;Phase;Physics;Predictive Value;Protocols documentation;prototype;Reporting;Research;Research Personnel;Retrospective Studies;Risk;Risk Assessment;risk prediction;risk stratification;Rupture;Scanning;Secure;shear stress;Site;software as a medical device;standard of care;success;surveillance imaging;System;Technical Expertise;Techniques;Technology;Testing;Thoracic Aortic Aneurysm;Time;timeline;Training;Universities;Validation;validation studies;Vendor;Visualization

PROJECT_TITLE: Anatomic Imaging Derived 4D Hemodynamics using Deep Learning

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-Z (10)]