ORG_CITY: ANDOVER

ORG_NAME: PHYSICAL SCIENCES, INC

PHR: Project Narrative The focus of this project is to develop an optical sensing probe system that monitors cellular compounds in the biopharmaceutical production of gene therapy drugs. The real-time and in-line spectroscopic measurement data of cellular characteristics will promote the understanding and monitoring of cell-culture bioprocesses, and eventually promote gene therapeutic product manufacturing for clinical use.

PI_NAMEs: PARK, JESUNG  (contact)

PROGRAM_OFFICER_NAME: GERSHENSON, ANNE

PROJECT_TERMS: 3-Dimensional;Adenine;Adopted;Affect;Agitation;Amino Acids;Anabolism;Biological Products;Biological Response Modifier Therapy;Biomanufacturing;bioprocess;Bioreactors;Biotechnology;Capsid;Cell Culture Techniques;Cell Differentiation process;Cell Extracts;Cells;Cellular Morphology;Characteristics;Chromatography;Clinical;clinical application;Collaborations;commercialization;Cultured Cells;Cytometry;Cytosine;Data;Defect;design;Development;Disease;DNA;drug production;Embryo;Environment;extracellular;fluorophore;Gene Delivery;gene product;gene therapy;Gene Transduction Agent;Genes;Goals;Guanine;Harvest;Hereditary Disease;high standard;Human;improved;Inherited;innovation;innovative technologies;instrument;Investments;Joints;Kidney;Knowledge;large scale production;Mammalian Cell;manufacture;manufacturing capabilities;Massachusetts;Measurement;Measures;Medical Technology;Metabolism;Methionine;Methodology;miniaturize;Molecular;Monitor;multimodality;Mutation;novel;Nucleotides;operation;Optics;Organism;Performance;Pharmaceutical Preparations;Phase;Phenylalanine;Physical Efforts;physical science;prevent;Process;process improvement;Production;Productivity;programs;Proteins;prototype;Quality Control;real time monitoring;Research;research and development;Resolution;Sampling;sensor;Signal Transduction;Specificity;Spectrum Analysis;success;Suspension Culture;System;Techniques;Technology;technology development;temporal measurement;Testing;Therapeutic;therapeutic gene;Thymine;Time;tool;Tryptophan;Tyrosine;ultraviolet;Universities;Uracil;Validation;Viral;Viral Vector;virtual

PROJECT_TITLE: Virtual chromatographic cytometry for in-line biomanufacturing process analysis

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


ADMINISTERING_IC: HD

ARRA_FUNDED: N

FUNDING_MECHANISM: SBIR-STTR RPGS

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

NIH_SPENDING_CATS: Bioengineering;Cardiovascular;Clinical Research;Contraception/Reproduction;Hypertension;Kidney Disease;Maternal Health;Maternal Morbidity and Mortality;Nanotechnology;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Pregnancy;Prevention;Women's Health Research

ORG_CITY: ROCHESTER

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: SERSENSE, INC.

ORG_STATE: MN

PHR: Preeclampsia is one of the most common causes of pregnancy complications in the United States and world- wide. The objective of this project is to develop a simple and sensitive diagnostic test for detection of preeclampsia.

PI_NAMEs: STYBAYEVA, GULNAZ  (contact)

PROGRAM_OFFICER_NAME: ILEKIS, JOHN V

PROJECT_TERMS: Albumins;Antibodies;Appearance;Benchmarking;biobank;Biological Markers;Blood capillaries;Caring;Clinic;Clinical;clinical diagnostics;cohort;companion diagnostics;Complex;cost;cytokine;design;Detection;detection platform;detection test;Diagnosis;Diagnostic tests;Disease;disorder subtype;Electrodes;Etiology;extracellular vesicles;fetal;Flow Cytometry;Future;Hospitals;Hypertension;Immunoassay;improved;Inflammatory;Ions;Kidney;kidney epithelial cell;Label;lead ion;manufacture;Metals;Monitor;Morbidity - disease rate;mortality;Mothers;nanoflow cytometry;nanoparticle;nephrin;normotensive;novel;novel marker;NPHS2 protein;Oxidation-Reduction;Pathogenesis;Patient Care;patient screening;Patients;Pharmaceutical Preparations;Phase;Physicians;podocyte;Pre-Eclampsia;Pregnancy;Pregnancy Complications;Pregnant Women;Prenatal care;prognostic assays;Proteins;Proteinuria;prototype;Reader;Reporter;Risk;Sampling;screening;senescence;senolytics;Signal Transduction;Signs and Symptoms;Small Business Technology Transfer Research;Specificity;Surface;Surface Plasmon Resonance;Syndrome;Techniques;Technology;Test Result;Testing;Therapeutic Intervention;treatment response;United States;urinary;Urine;Vision;Woman

PROJECT_TITLE: Detection of extracellular vesicles in urine for diagnosis of preeclampsia

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


ADMINISTERING_IC: MD

IC_NAME: NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES

NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Childhood Obesity;Clinical Research;Clinical Trials and Supportive Activities;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Nutrition;Obesity;Pediatric;Physical Activity;Prevention;Primary Health Care;Rural Health;Social Determinants of Health

ORG_CITY: SAINT PAUL

ORG_NAME: MINNESOTA HEALTHSOLUTIONS CORPORATION

PHR: Project Narrative Engagement in health promoting behaviors can improve health and wellbeing, and may be especially important for rural populations in the US and worldwide. Non-communicable disease is the leading driver of poor health and the cause of 70% of deaths worldwide.8 Many NCDs are preventable and associated with modifiable risk factors such as poor dietary quality (low intake of fruits and vegetables, high intake of fast food and sugary beverages), physical inactivity, excessive sedentary behavior, and excessive weight gain/obesity.

PI_NAMEs: BIGGS, BRIDGET KATHLEEN;KNUTSON, MATTHEW  (contact)

PROGRAM_OFFICER_NAME: GOGINENI, ARUNDHATI

PROJECT_TERMS: Accountability;Address;Adolescent;Adoption;Behavior;behavior change;Behavior Therapy;Behavioral;behavioral health;Beverages;Caregivers;Cessation of life;Child;Childhood;Clinic;Collaborations;Consumption;Credentialing;design;Development;dietary;digital applications;digital health;digital platform;Disease;Disparity;Eating;Effectiveness;efficacy testing;Electronic Mail;excessive weight gain;experience;Family;family support;fast food;Feedback;fruits and vegetables;Funding;Goals;Grant;Habits;Health;Health and Behavior in Children;health application;Health behavior;Health behavior change;health care delivery;health disparity;Health Promotion;Healthcare;human study;Hypertension;improved;Incidence;Indigenous;Individual;Intake;Internet;Intervention;iterative design;Mental Health;Methods;mHealth;Mind;Minnesota;Minority Groups;modifiable risk;Monitor;Non-Insulin-Dependent Diabetes Mellitus;Not Hispanic or Latino;Obesity;Outcome;Overweight;Parents;patient engagement;Patients;Personal Satisfaction;Phase;phase 2 study;physical inactivity;Population;prevent;primary care clinic;Process;programs;promoter;prototype;Psychologist;Research;Research Support;Resources;response;Risk;Risk Factors;Rural;rural dwellers;rural families;Rural Population;rural setting;Science;Scientist;screening;Screening procedure;sedentary lifestyle;Software Engineering;South Carolina;Technology;Testing;Text Messaging;theories;tool;Trust;Underserved Population;usability;Weight maintenance regimen;Well Child Visits;Work

PROJECT_TITLE: Inclusive Online Interactive Platform for Parents in Rural Settings to Promote Healthy Habits

STUDY_SECTION_NAME: Special Emphasis Panel[ZMD1 JT (J1)]


ADMINISTERING_IC: VA

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: Veterans Affairs

ORG_CITY: BOSTON

ORG_NAME: VA BOSTON HEALTH CARE SYSTEM

ORG_STATE: MA

PHR: Alzheimer’s disease and related dementias (ADRD) affect approximately 10% of the US population, with prevalence increasing with age (e.g., 3% between ages 65–74 to 32% for people over the age of 85). The US Department of Veterans Affairs (VA) has placed a high priority on clinical research on ADRD in part because over half of all the veterans it serves are now over 65 years of age. Inherited variations in the molecular blueprint of life, known as DNA, play a major role in conferring risk for ADRD. Epigenetic variation consisting of chemical modifications of DNA that influence the expression of genes have not yet been thoroughly studied as factors that confer risk for ADRD. This study will use data from VA’s Million Veteran Program to examine epigenetic contributions to ADRD risk with the aim of identifying blood-based biomarkers that may eventually be used to guide the development of blood-based assays for use with patients at risk for, or diagnosed with, ADRD.

PI_NAMEs: MILLER, MARK W (contact)

PROJECT_TERMS: Affect;African ancestry;Age;Age Years;Alzheimer's disease related dementia;Alzheimer's disease risk;Alzheimer’s disease biomarker;Biological Assay;Biology;Black American;Black race;Blood;blood-based biomarker;carrier status;case control;Cerebrospinal Fluid;Chemicals;clinical diagnosis;Clinical Research;cohort;Cohort Analysis;cost;Cross-Sectional Studies;Data;dementia risk;Development;Diagnosis;Disease Progression;Disparity;DNA;DNA Methylation;DNA Modification Process;Enrollment;Epigenetic Process;epigenetic variation;epigenome-wide association studies;European;European ancestry;Evaluation;Gene Expression;Genetic;Genetic Risk;genetic risk factor;genome-wide;Genotype;human old age (65+);Individual;Inherited;Life;Mediating;Mediator;Meta-Analysis;Methylation;minimally invasive;Molecular;Monitor;Not Hispanic or Latino;Participant;Patients;Persons;Play;polygenic risk score;Population;Positron-Emission Tomography;Post-Traumatic Stress Disorders;predictive marker;Prevalence;Procedures;prognostic;programs;psychiatric genomics;Race;racial disparity;Recording of previous events;Regression Analysis;Research;Retrospective cohort;Risk;risk variant;Role;Running;Site;statistics;Survival Analysis;Time;treatment response;United States Department of Veterans Affairs;Variant;Veterans

PROJECT_TITLE: The epigenetics of dementia risk in the Million Veteran Program

STUDY_SECTION_NAME: Special Emphasis Panel[ZRD1 NURD-E (01)]


ADMINISTERING_IC: CA

ED_INST_TYPE: SCHOOLS OF MEDICINE

FUNDING_MECHANISM: RESEARCH CENTERS

IC_NAME: NATIONAL CANCER INSTITUTE

ORG_CITY: NEW HAVEN

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: YALE UNIVERSITY

ORG_STATE: CT

PHR: Not required per guidelines.

PI_NAMEs: HERBST, ROY S (contact);MUZUMDAR, MANDAR DEEPAK;POLITI, KATERINA ABIGAIL;WANG, SIYUAN

PROGRAM_OFFICER_NAME: UJHAZY, PETER

PROJECT_TERMS: 3-Dimensional;acquired drug resistance;Address;Adoption;analytical method;Animal Model;Automobile Driving;Award;Binding;Biochemical;biochemical tools;Biochemistry;Biology;Cancer Biology;cancer cell;Cancer cell line;Cell Culture Techniques;Cells;Characteristics;Chromatin;chromatin remodeling;Clinic;Clinical;Data;Dependence;Development;Diagnosis;DNA Sequence Alteration;Drug resistance;Effectiveness;Epidermal Growth Factor Receptor;Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor;Epigenetic Process;epigenetic profiling;epigenome;Erlotinib;Exons;experimental study;Family member;Fostering;Frequencies;Gefitinib;Gene Dosage;Gene Expression Profile;Generations;Genes;Genetic;Genetic Transcription;Genome;genomic tools;Genotype;Guidelines;Heterodimerization;Homo;Human;Human Cell Line;improved outcome;In Situ;In Vitro;in vivo Model;Individual;innovation;Knowledge;Lung Adenocarcinoma;Malignant neoplasm of lung;Malignant Neoplasms;Mediating;Mediator;Methods;Modeling;Molecular;Molecular Conformation;mouse model;mutant;Mutation;Nature;Neoplasm Metastasis;new therapeutic target;novel;novel therapeutics;Oncogenes;Oncogenic;parent project;Parents;patient derived xenograft model;patient response;patient subsets;Patients;Pattern;personalized medicine;Pharmaceutical Preparations;pharmacologic;Pre-Clinical Model;predictive marker;Prognostic Marker;programs;Progression-Free Survivals;Property;receptor;Resistance;resistance mechanism;resistance mutation;Resources;Role;single cell analysis;SMARCA4 gene;Speed;stemness;structural biology;Structure;success;targeted treatment;Technology;Testing;Therapeutic;Three-dimensional analysis;three-dimensional visualization;Time;Tissues;Toxic effect;treatment strategy;tumor;tumor initiation;tumor progression;Tumor Suppressor Genes;Tyrosine Kinase Domain;Tyrosine Kinase Inhibitor;Variant;Work

PROJECT_TITLE: Yale SPORE in Lung Cancer (YSILC): The Biology and Personalized Treatment of Lung Cancer

STUDY_SECTION_NAME: Special Emphasis Panel[ZCA1 TCRB-D (M2)]


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Behavioral and Social Science;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Drug Abuse (NIDA only);Mental Health;Prevention;Substance Misuse;Telehealth

ORG_CITY: HANOVER

ORG_NAME: SQUARE2 SYSTEMS, INC.

ORG_STATE: NH

PHR: Project Narrative The proposed project will be the first to commercialize a unique transdiagnostic digital therapeutics development and hosting platform grounded in the science of behavior change for any population. This will replace the currently time- and cost-inefficient processes of developing bespoke digital therapeutics and rapidly accelerate the pace at which science-based digital therapeutics can transform healthcare.

PI_NAMEs: GRABINSKI, MICHAEL JOHN (contact)

PROGRAM_OFFICER_NAME: ANGELONE, LEONARDO MARIA

PROJECT_TERMS: Acceleration;Accident and Emergency department;Achievement;addiction;Address;Adherence;Alcohol consumption;Anxiety;Attention deficit hyperactivity disorder;Behavior;behavior change;Behavior Therapy;Behavioral;behavioral health;Binge eating disorder;Budgets;Cardiology;Caring;chronic pain;chronic pain patient;Clinical;Clinical Research;commercialization;Communities;Computer software;cost;Development;diabetes management;Diabetes Mellitus;Diagnostic;Diet;digital delivery;digital health;digital platform;digital treatment;Disease;Disease remission;Drops;drug abstinence;Eating Disorders;Emergency department visit;Ethnic Origin;Evaluation;evidence base;Exercise;experience;functional improvement;Funding;Future;Health;Health behavior;Health behavior and outcomes;Health Care Costs;health equity;Healthcare;improved;Individual;Inpatients;interest;Language;Learning;marijuana use;Medical;medication compliance;Mental Depression;Mental Health;Modeling;National Institute of Drug Abuse;Nature;nicotine use;Oncology;opioid use;overdose death;Pain management;Panic Disorder;Participant;patient oriented;Persons;Pharmaceutical Preparations;Phase;polysubstance use;Population;prevent;Prevention;Problem behavior;Process;prototype;Race;Regimen;Research;research clinical testing;Research Personnel;respiratory;Schizophrenia;Science;Scientist;Sex Orientation;skills;Small Business Innovation Research Grant;Smoking;stimulant use;substance use;Substance Use Disorder;substance use treatment;System;Target Populations;Testing;Therapeutic;therapeutic development;Time;tool;Transcend;United States National Institutes of Health;usability;Work

PROJECT_TITLE: Cogito:  A turnkey solution for rapidly developing, evaluating, deploying, and scaling digital therapeutics

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


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Cancer;Emerging Infectious Diseases;Infectious Diseases;Rare Diseases

ORG_CITY: CLEVELAND

ORG_DEPT: OTHER BASIC SCIENCES

ORG_NAME: CLEVELAND CLINIC LERNER COM-CWRU

ORG_STATE: OH

PHR: Project Narrative This application will investigate how KSHV deregulates host spermidine and proline metabolic pathways for LANA expression and whether the spermidine and proline metabolic pathways are therapeutic targets for KSHV persistency and oncogenesis.

PI_NAMEs: JUNG, JAE U (contact)

PROGRAM_OFFICER_NAME: PARK, EUN-CHUNG

PROJECT_TERMS: 3-Dimensional;Affect;Anabolism;C-terminal;cell dimension;cell growth;Cell Proliferation;Cells;Drug Targeting;Enzymes;Etiology;Eukaryotic Initiation Factors;Genetic Transcription;Herpesviridae Infections;Human Herpesvirus 8;In Vitro;in vivo;inhibitor;Kaposi Sarcoma;latency-associated nuclear antigen;latent nuclear antigen;Lymphoma;Maintenance;Malignant Neoplasms;Mediating;Metabolic;Metabolic Pathway;Metabolism;metabolomics;mouse model;neoplastic cell;novel;Oncoproteins;Ornithine Decarboxylase;Pathway interactions;Peptides;Pleural effusion disorder;Polyamines;polyproline;Post-Translational Protein Processing;Production;programs;Proline;Property;Proteins;pyrroline 5 carboxylate reductase;Regulation;Reporting;small molecule;Spermidine;spheroids;System;Therapeutic;therapeutic target;Translations;tumor;Tumor Promotion;tumorigenesis;two-dimensional;Viral;Virus Latency

PROJECT_TITLE: KSHV-mediated metabolic reprogramming for LANA expression and viral persistency

STUDY_SECTION: HCAC

STUDY_SECTION_NAME: HIV Coinfections and HIV Associated Cancers Study Section[HCAC]


NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Emerging Infectious Diseases;HIV/AIDS;Infectious Diseases;Lung;Orphan Drug;Rare Diseases;Tuberculosis

ORG_CITY: LOS ANGELES

ORG_NAME: UNIVERSITY OF CALIFORNIA LOS ANGELES

ORG_STATE: CA

PHR: PROJECT NARRATIVE: RELEVANCE TO PUBLIC HEALTH Approximately 2 billion people on earth have latent tuberculosis infection (LTBI), many of whom reactivate TB later in life, often in association with an immunocompromised status, such as co-infection with HIV, immunotherapy for cancer or other diseases, aging, etc., and they thus constitute an enormous reservoir for continued propagation of the TB pandemic. Effective treatment of LTBI can prevent reactivation, but currently approved regimens are long and burdensome, negatively impacting treatment completion. The study proposed herein seeks to examine the efficacy of a novel ultra-short 3-drug regimen compared to a standard regimen for treating LTBI in non-human primates in a setting mimicking co-infection with HIV, and if successful, and then replicated in humans, such a short-term regimen could revolutionize the treatment of LTBI, hastening the elimination of the TB reservoir and subsequently TB.

PI_NAMEs: HORWITZ, MARCUS AARON (contact);KAUSHAL, DEEPAK

PROGRAM_OFFICER_NAME: PROTOPOPOVA, MARINA

PROJECT_TERMS: active method;Aerosols;Aging;antagonist;Artificial Intelligence;Bacteria;Biological Assay;Blood;cancer immunotherapy;Cell Culture Techniques;clinical practice;co-infection;Development;Disease;Dose;Drug Combinations;Drug Kinetics;Drug usage;drug-sensitive;effective therapy;efficacy evaluation;Ethambutol;Evaluation;experimental study;Funding;Genus Mycobacterium;Goals;Haiti;high throughput screening;HIV;HIV Infections;Human;human study;Immunocompromised Host;improved;In Vitro;Inbred BALB C Mice;Infection;Infection prevention;Interferon Type II;isoniazid;Life;Macrophage;Meta-Analysis;Methods;Modeling;Monitor;mouse model;Mycobacterium tuberculosis;nonhuman primate;novel;pandemic disease;Patients;Persons;Pharmaceutical Preparations;Phase;Planet Earth;Populations at Risk;Predisposition;Prevalence;prevent;Public Health;Pulmonary Tuberculosis;Pyrazinamide;Recommendation;Regimen;Relapse;Resistance;response;rifapentine;Safety;SIV;South Africa;standard care;Surface;synergism;Technology;Testing;Time;Treatment Protocols;Tuberculin Test;Tuberculosis;tuberculosis treatment;United States National Institutes of Health

PROJECT_TITLE: Efficacy and Safety of AI-enabled PRS Regimen VI (Clofazimine, Bedaquiline and Pyrazinamide) as Ultra-Short Course Therapy of LTBI in Non-Human Primates in a setting mimicking HIV co-infection


NIH_SPENDING_CATS: Antimicrobial Resistance;Bioengineering;Infectious Diseases;Wound Healing and Care

ORG_CITY: LAKE FOREST

ORG_NAME: ALLVIVO VASCULAR, INC.

PHR: PROJECT NARRATIVE Biofilms are present on over 75% of chronic wounds where they contribute to patient discomfort, impaired healing and wound chronicity. The goal of this work is to develop a treatment that is effective against wound biofilm, including drug resistant bacteria. The product will fill a critical gap in the need for antimicrobial treatments that are biocompatible and conducive to healing. If successful, the product is expected to have a substantial impact on the treatment and quality of life of patients with chronic wounds by reducing infection, pain, odor, and amputation risks.

PI_NAMEs: NEFF, JENNIFER ANN (contact)

PROGRAM_OFFICER_NAME: XU, ZUOYU

PROJECT_TERMS: Adherence;Affect;age acceleration;Amputation;Animal Model;anti-microbial peptide;Antibiotics;antimicrobial;Antimicrobial Cationic Peptides;Bacteria;biomaterial compatibility;Capital;Caring;Cells;Cessation of life;cGMP production;Chitosan;Chlorhexidine;chronic wound;clinical efficacy;Clinical Trials;combat wound;cost;Crowding;Cyclic GMP;cytotoxicity;Data;design;Devices;Dose;drug resistant bacteria;Engineering;Ensure;Environment;Equipment and supply inventories;Formulation;Foundations;Gatekeeping;Generations;Goals;healing;Health Care Costs;Hydrogels;Impaired healing;improved;In Vitro;Infection;Inflammation;Intervention;Investments;Iodine;irritation;Label;Lead;Life;manufacture;manufacturing process;Marketing;meetings;Microbial Biofilms;Miniature Swine;Multiple Bacterial Drug Resistance;non-healing wounds;novel;novel therapeutics;Odors;Pain;patient retention;Patients;Peptides;Perfusion;Persons;Phase;polymicrobial biofilm;Porifera;Positioning Attribute;Preclinical Testing;prevent;Process;Production;Productivity;Quality of life;Recording of previous events;Recurrence;repaired;Reproducibility;Risk;Safety;safety study;Silver;Site;Specific qualifier value;stability testing;standard of care;stem;Sterile coverings;Sterility;Sterilization;success;technology platform;Temperature;Testing;Time;Tissues;Traction;Treatment Cost;Validation;verification and validation;Work;wound;wound bed;wound biofilm;wound care;wound closure;wound healing;Wound Infection;wound treatment

PROJECT_TITLE: Antimicrobial Treatment to Combat Wound Biofilm

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


ORG_CITY: AUSTIN

ORG_NAME: UNIVERSITY OF TEXAS AT AUSTIN

ORG_STATE: TX

PHR: Narrative Current methods for tissue biopsy methods are prohibitively painful and thus not recommended for comprehensive melanoma screening in adult individuals, resulting in significant missed cancers. Noninvasive methods that sample only the top layer of the skin for molecular (non-histological) analyses are not widely used for melanoma diagnosis, likely due to collection of biomarkers from superficial skin rather than from melanocytes that are deeper under the skin. In this proposal, we propose development of a new laser microbiopsy that will allow tissue extraction beyond the epidermis, where melanocytes are located, with less pain compared to traditional biopsies. This minimally-invasive laser microbiopsy can be used for histological and molecular diagnostics, which will hopefully allow for comprehensive melanoma screening to reduce the disease burden.

PI_NAMEs: PAREKH, SAPUN H (contact);TUNNELL, JAMES W

PROGRAM_OFFICER_NAME: GUAN, PING

PROJECT_TERMS: Address;Adopted;Adult;Affect;Animals;Benign;Biological Markers;Biopsy;Biopsy Specimen;burden of illness;Cancer Detection;Cell Culture Techniques;Cells;Cessation of life;Clinic;Clinical;Collection;Computer Models;conditioning;Cone;Cytology;Data;Dependence;Development;Device Designs;Devices;Diagnosis;Diameter;Disease;dosimetry;Early Diagnosis;Ensure;Epidermis;Excision;experimental study;Family suidae;Feasibility Studies;feasibility testing;Flow Cytometry;Future;Genetic;genetic analysis;genetic approach;Genetic Markers;Geometry;Harvest;Histologic;Histology;Histopathology;Human;Ice Cream;Image;Immunofluorescence Immunologic;improved;in silico;Individual;Lasers;Lesion;Light;Lighting;Malignant Neoplasms;Mass Spectrum Analysis;mechanical properties;Mechanics;melanocyte;Melanoma;melanoma biomarkers;meter;Methods;Microscope;microscopic imaging;Microscopy;minimally invasive;Modeling;Mole the mammal;Molecular;Molecular Analysis;molecular diagnostics;Morphology;new technology;Operative Surgical Procedures;Optical Coherence Tomography;optical imaging;Optics;Outcome;Pain;Pain Free;Pathologic;Pathology;Penetration;Performance;Phase;Physiologic pulse;preconditioning;Primary Cell Cultures;Procedures;Process;Property;Protein Analysis;Proteins;Punch Biopsy;RNA;Sampling;screening;Screening for Skin Cancer;Screening procedure;Shapes;Skin;Skin Cancer;Slide;Specificity;Stains;standard of care;stem;Stratum Basale;Stratum corneum;Surface;Survival Rate;Techniques;Technology;Testing;Time;tissue culture;Tissue Harvesting;Tissue Viability;Tissues;tool;transcriptomics;tumor;United States Preventative Services Task Force;Visual;Work

PROJECT_TITLE: Precision Tumor Sampling of Melanoma Using Laser Microbiopsy

STUDY_SECTION_NAME: Special Emphasis Panel[ZCA1 TCRB-J (M1)]


ADMINISTERING_IC: MH

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

ORG_CITY: ANN ARBOR

ORG_NAME: SPIKE NEURO LLC

ORG_STATE: MI

PHR: Narrative Many neurological disorders and diseases have both electrophysiology and neurochemical etiologies; however, these biomarkers are rarely studied in tandem due to the lack of available tools. There is a critical need for neuroscience tools that enable multi-channel, high temporal recording of multiple neurochemicals and electrophysiology signals simultaneously to support the development of clinical multi-biomarker, closed-loop stimulation systems for the study and treatment of neurological conditions including Parkinson’s Disease, epilepsy, depression, drug abuse, and other neurological disorders. Dr. Alexander Zestos of American University and Spike Neuro are partnering together to develop carbon modified Silicon and Silicon-Carbide microelectrodes for dual-function neurochemistry and electrophysiology recording to address these gaps in the field.

PI_NAMEs: ZESTOS, ALEXANDROS GEORGE (contact)

PROGRAM_OFFICER_NAME: DURKIN, JACLYN MARIE

PROJECT_TERMS: Address;Adenosine;Adopted;American;Area;base;Biocompatible Materials;Biological Markers;biomaterial compatibility;Biosensor;Brain;Brain region;Carbon;carbon fiber;Chemicals;Chemistry;Chronic;Clinical;clinical application;clinical development;clinical practice;Cobalt;commercialization;commercially viable technology;Communities;cost effective;Coupled;Deep Brain Stimulation;Deposition;design;Detection;Development;Device or Instrument Development;Devices;Dopamine;Drug abuse;Electric Stimulation;Electrodes;Electrophysiology (science);Electroplating;Epilepsy;Etiology;FDA approved;Future;Glass;Goals;improved;In Vitro;in vitro testing;in vivo;innovation;interest;Longevity;Measurement;Measures;Medical Device;Mental Depression;Metals;Methods;Microelectrodes;Microfabrication;mid-career faculty;minimally invasive;multi-electrode arrays;Nervous System;Nervous System Disorder;Nervous System Physiology;neurochemistry;Neurologic;Neurosciences;Neurosciences Research;neurotransmission;Neurotransmitters;Norepinephrine;novel;Parkinson Disease;patient oriented;Periodicity;Play;Process;Production;prospective;Research;Resistance;Rodent;Role;Scanning;sensor technology;Serotonin;Shapes;Signal Transduction;Silicon;silicon carbide;Slice;Small Business Technology Transfer Research;Standardization;Structure;System;Techniques;technology platform;temporal measurement;Testing;Titanium;tool;tool development;Universities;vapor;Water;Work

PROJECT_TITLE: Dual-function Carbon Modified-Silicon Microelectrodes for Biomolecule Detection with Fast Scan Cyclic Voltammetry and Electrophysiology Recording and Stimulation

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


NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Dissemination and Implementation Research;Drug Abuse (NIDA only);Harm Reduction for Substance Misuse;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Homelessness;Mental Health;Prevention;Recovery Support Services;Social Determinants of Health;Substance Misuse

ORG_CITY: Springfield

ORG_NAME: OREGON RES BEHAVIORAL INTERVENTION STRAT

ORG_STATE: OR

PHR: Project Narrative Our proposed research centers on a pressing public health challenge: promoting the housing stability of people with substance use disorders (SUD) by intervening through direct support and staff training within permanent supportive housing (PSH) communities. To improve the stability of residents in PSH, we are proposing a Phase 1 SBIR to: 1) create and pilot a prototype of a harm reduction-focused voice-activated smart speaker intervention leveraging cognitive behavioral therapy informed skills and skills application combined with contingency management, and 2) conduct usability testing of a web-based harm reduction training for housing staff to improve ability and confidence to utilize harm reduction principles. The implementation of this integrated intervention that provides both resident support and housing staff training has the potential to improve residents’ outcomes by preventing the eviction of PSH residents for substance-use related reasons and thereby improving the long-term stability of people with SUD who are the most impacted by evictions.

PI_NAMEs: CIOFFI, CAMILLE C;SMITH, DAVID RANDOLPH (contact);SNOW-HILL, NYSSA

PROGRAM_OFFICER_NAME: FLOOD, MORRIS

PROJECT_TERMS: Abstinence;Address;Area;automated intervention;Behavior;Behavioral;Benchmarking;Caring;Cognitive Therapy;Collaborations;Communities;community based participatory research;community collaboration;community engaged research;community partners;Complex;Consolidated Framework for Implementation Research;contingency management;Country;Data;design;Discrimination;Education;Educational Intervention;Educational process of instructing;Effectiveness;Evaluation;evidence base;experience;Face;Feedback;Goals;Harm Reduction;Health Resources;Home;Housing;housing instability;implementation intervention;implementation strategy;improved;Incentives;Individual;innovation;Intensive Care;Intervention;Knowledge;Lead;Learning Module;marginalization;Marketing;Mental Health;Online Systems;Outcome;Overdose;Persons;Phase;physical conditioning;Population;Preparation;prevent;programs;Property;prototype;Public Health;Quality of Care;randomized trial;Recording of previous events;remote intervention;Reporting;Research;Resources;Security;Self Efficacy;skills;Small Business Innovation Research Grant;smart speaker;Social isolation;social stigma;Source;staff intervention;Standardization;substance use;Substance Use Disorder;supported housing;System;technological innovation;Technology;Testing;Training;United States;uptake;usability;Use Effectiveness;Voice;Work

PROJECT_TITLE: Innovating Technology Solutions for Residents in Supportive Housing Communities with SUD through Community-Engaged Research

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


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Clinical Research;Diabetes;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Networking and Information Technology R&D (NITRD);Neurodegenerative;Neurosciences;Peripheral Neuropathy;Prevention;Primary Health Care;Racial and Ethnic Minority Health Research;Rural Health;Social Determinants of Health

ORG_CITY: ALBUQUERQUE

ORG_NAME: VISIONQUEST BIOMEDICAL INC

ORG_STATE: NM

PHR: NARRATIVE Diabetic peripheral neuropathy (DPN) is the most common comorbidity of diabetes, but a lack of standard screening protocols creates an unmet need in resource limited settings, and no single tool objectively measures DPN symptoms. A shortage of providers also creates barriers to preventative care and treatment, especially in rural areas, yet research has shown that screening contributes to better medical and economic outcomes. VisionQuest’s development of more effective DPN screening tools for use with underserved populations will improve compliance with diabetic foot exams and prevent debilitating and costly complications that lead to ulcers and amputations.

PI_NAMEs: SOLIZ, PETER N (contact)

PROGRAM_OFFICER_NAME: COOKE, BRAD

PROJECT_TERMS: Address;Adherence;African American population;American Medical Association;Amputation;artist;Assessment tool;Awareness;bilingualism;Biological Markers;Blood Vessels;Body mass index;Books;Caring;Cellular Phone;Clinical;Clinical Data;clinical decision-making;clinical examination;Clinical Research;Collaborations;commercialization;Communication;comorbidity;Computer software;cost;Data;Databases;Decision Support Systems;Detection;Development;Devices;Diabetes Mellitus;diabetic;Diabetic Foot;diabetic patient;Diagnostic tests;Economic Burden;economic outcome;Economics;Education;Educational Materials;effectiveness testing;Eligibility Determination;Environmental Health;ethnic minority;experience;Exposure to;Eye;Failure;Feedback;foot;Glycosylated hemoglobin A;Grant;Health;health care availability;health inequalities;Image;imager;imaging capabilities;Imaging Device;imaging system;improved;Inequity;innovation;Journals;Latino Population;Measures;Medical;Medical Records;Minority Groups;Morbidity - disease rate;mortality;nerve conduction study;Nurses;outreach program;Patients;Performance;Periodicals;Peripheral Nervous System Diseases;Persons;Phase;Physiologic Thermoregulation;portability;prevent;Preventive care;Preventive treatment;Price;primary care setting;Printing;prospective;Provider;Questionnaires;racial minority;Recommendation;Reference Standards;Reporting;Research;Research Personnel;research study;Resource-limited setting;response;Risk;rural area;screening;Screening procedure;screening program;Sensory;Signal Transduction;Signs and Symptoms;smartphone based device;social;socioeconomics;Spanish/English;Specialist;Specificity;Symptoms;System;Systems Integration;Techniques;Technology;Temperature;Test Result;Testing;tool;Ulcer;underserved community;Underserved Population;Validation;Visual;Work

PROJECT_TITLE: Access to diabetic peripheral neuropathy screening for underserved communities


ADMINISTERING_IC: GM

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Cancer;Data Science;Gene Therapy;Genetics;Hematology;Immunotherapy;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Orphan Drug;Rare Diseases

ORG_CITY: DENVER

ORG_NAME: URSA ANALYTICS, INC.

ORG_STATE: CO

PHR: Project Narrative  A wealth of image information characterizing particles inherent to biologic drug products has been collected by the pharmaceutical industry, but only a fraction of the information content encoded in the images has been utilized to date. In this project, new unsupervised AI image analysis algorithms will be developed for analyzing large collections of high-throughput microscopy measurements of biological particles. This SBIR will focus on using the information extracted from the AI analysis to assist in quality control and efﬁcient CAR-T cell production.

PI_NAMEs: CALDERON, CHRISTOPHER PETER (contact);RANDOLPH, THEODORE W

PROGRAM_OFFICER_NAME: TAYLOR, VERONICA

PROJECT_TERMS: Academia;Address;Algorithmic Analysis;Algorithms;Allogenic;autoencoder;Autologous;Automobile Driving;Biological;Biological Products;Buffers;CAR T cell therapy;Catalogs;Categories;Cell Culture Techniques;cell injury;Cell Survival;Cells;cellular imaging;chimeric antigen receptor T cells;Collaborations;Collection;Communicable Diseases;Complex;Computer software;convolutional neural network;cost;cost effective;Cryopreservation;Cytoprotection;Data;density;design;Dimensions;Disease;Drug Formulations;Drug Industry;drug production;Exhibits;Face;falls;Flow Cytometry;Formulation;Freezing;Gold;Good Manufacturing Process;Government Agencies;Harvest;Human;Image;Image Analysis;image processing;Immersion;improved;Industry;instrument;interest;Isotonic Exercise;Label;lentivirally transduced;leukemia;Liquid substance;Lymphoma;Machine Learning;machine learning algorithm;machine learning method;Malignant Neoplasms;Mammalian Cell;manufacture;Marketing;Measurement;Measures;Medicine;Membrane;Methods;microscopic imaging;Microscopy;Modernization;Monitor;Monoclonal Antibodies;Morphology;Multiple Myeloma;neural network algorithm;Oils;Osmotic Shocks;particle;Particle Size;Particulate Matter;Patients;personalized medicine;Pharmaceutical Preparations;Pharmacologic Substance;Phase;Population;Process;process optimization;Production;Quality Control;Regulation;Research;Resolution;Safety;Semantics;side effect;Small Business Innovation Research Grant;small molecule;Software Tools;Specificity;Stains;statistics;success;supervised learning;System;T-Cell Receptor Therapy;T-Lymphocyte;Techniques;therapeutic protein;Time;tool;Training;unsupervised learning;Work

PROJECT_TITLE: High-Throughput, Label-Free, Unsupervised Image Analysis of CAR-T Cell Data

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


NIH_SPENDING_CATS: Biomedical Imaging;Biotechnology;Cancer;Orphan Drug;Ovarian Cancer;Prevention;Radiation Oncology;Rare Diseases;Women's Health Research

ORG_CITY: RALEIGH

ORG_NAME: ONCURIE INC.

ORG_STATE: NC

PHR: Project Narrative  Ovarian cancer is often only detected in late stages which limits treatment strategies and results in poor 5-year survival statistics. Oncurie has developed a novel targeted imaging radiopharmaceutical, O5, which selectively targets the folate receptor, a surface protein known to be upregulated in a range of malignancies including ovarian cancer. To date, O5 has been shown to reliably bind to ovarian cancer cells through the folate receptor and reveals xenograft tumors in murine models. This Phase I program will refine the structure, test its effectiveness in other ovarian cancer cells, and evaluate its ability to target human-derived cancer cells in murine models.

PI_NAMEs: LAPI, SUZANNE ELIZABETH (contact)

PROGRAM_OFFICER_NAME: BOZZA, WILLIAM PATRICK

PROJECT_TERMS: Acids;Advanced Development;advanced disease;Affinity;Alabama;analog;Antioxidants;Ascorbic Acid;Binding;Biodistribution;cancer cell;Cancer cell line;cancer imaging;Cell Nucleus;Cells;Cessation of life;chemical synthesis;Chemistry;Clinical Research;Collaborations;Control Groups;Copper;Cytosol;cytotoxic;Data;Death Rate;design;Development;Diagnosis;Diagnostic Imaging;diagnostic tool;Diet;Disease;disease diagnosis;Dissociation;Doctor of Philosophy;Dose;Effectiveness;efficacy testing;Ensure;Flow Cytometry;folate-binding protein;Folic Acid;Formulation;Future;Goals;Growth;Gynecologic Oncologist;Harvest;Hepatic;Hour;Human;human disease;Image;imaging agent;improved;in vitro testing;in vivo;Investigational New Drug Application;Kidney;Label;Ligands;Light;Malignant neoplasm of ovary;Malignant Neoplasms;manufacturing quality;Marketing;Mediating;Membrane Proteins;Metabolic Clearance Rate;Methods;Molecular;Molecular Structure;Monitor;mouse model;Mus;nanomolar;novel;novel diagnostics;Organ;overexpression;Pathogenesis;patient derived xenograft model;Patients;Phase;Photophobia;Positron-Emission Tomography;preservation;prevent;programs;Property;Radiation therapy;Radioisotopes;Radiolabeled;radiological imaging;Radiopharmaceuticals;Reaction;receptor;receptor binding;receptor expression;Reporting;Route;Safety;Small Business Innovation Research Grant;Small Business Technology Transfer Research;Specificity;statistics;Structure;success;Survival Rate;targeted agent;targeted imaging;targeted treatment;Testing;theranostics;Therapeutic;Time;Titrations;Toxicology;translational model;treatment strategy;Triazoles;tumor;tumor xenograft;Universities;uptake;Woman;Xenograft Model

PROJECT_TITLE: A novel platform for targeted radiopharmaceuticals for imaging and therapy of ovarian cancer

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


ADMINISTERING_IC: NR

IC_NAME: NATIONAL INSTITUTE OF NURSING RESEARCH

NIH_SPENDING_CATS: Back Pain;Behavioral and Social Science;Chronic Pain;Clinical Research;Clinical Trials and Supportive Activities;Networking and Information Technology R&D (NITRD);Neurosciences;Pain Research

ORG_CITY: SUNNYVALE

ORG_NAME: COGNIFISENSE, INC.

PHR: PROJECT NARRATIVE CognifiSense has developed a unique, patented virtual reality therapy for chronic pain, called Virtual Reality Neuroscience-based Therapy (VRNT), which is specifically designed to create substantial and lasting pain reduction by targeting the centralized drivers of pain chronification and amplification. In a SBIR Phase I clinical proof of concept trial VRNT demonstrated clinically meaningful post-treatment improvements in pain, and brain imaging data provided preliminary evidence of neuroplastic changes in the brain to parallel chronic pain reduction. The goal of this Phase II project is to make the VRNT system market-ready and demonstrate its efficacy in a pivotal randomized controlled trial.

PI_NAMEs: BAEUERLE, TASSILO ;CEKO, MARTA ;WAY, AMANDA  (contact)

PROGRAM_OFFICER_NAME: KEHL, KAREN

PROJECT_TERMS: Active Learning;Acute;Acute Pain;addiction;Address;Adult;Affect;Aftercare;American;Behavioral;biopsychosocial;Brain;brain based;Brain imaging;Caring;Central Nervous System;Chronic low back pain;chronic pain;chronic pain management;Clinical;Clinical Data;clinical efficacy;Clinical Trials;clinically significant;Code;Cognitive;Cognitive Therapy;Complex;Computer software;cost;Data;Data Set;design;Devices;disability;Educational process of instructing;Emotional;emotional functioning;Enrollment;Exercise;experience;Feedback;follow up assessment;follow-up;Fright;Funding;Goals;improved;Industry;Injections;Legal patent;Long-Term Effects;Marketing;Masks;Medical;Medical Device;Minor;Modification;Movement;neural;neural circuit;neuroimaging;Neuronal Plasticity;Neurosciences;novel;Operative Surgical Procedures;Outcome;Pain;pain catastrophizing;pain chronification;Pain intensity;Pain interference;Pain management;pain perception;pain reduction;pain signal;Participant;Patients;Peripheral;Persistent pain;Persons;Pharmaceutical Preparations;Pharmacological Treatment;Phase;phase 1 study;phase II trial;Physical therapy;Placebo Control;primary outcome;Process;programs;psychologic;randomized, clinical trials;Randomized, Controlled Trials;Recommendation;Reporting;Research;Research Support;Risk;satisfaction;secondary outcome;Self Efficacy;side effect;skills;skills training;Sleep;Small Business Innovation Research Grant;Software Design;Specific qualifier value;standard care;System;Technology;Testing;Therapeutic;Time;Training;treatment duration;treatment effect;United States National Institutes of Health;Update;usability;virtual reality;Waiting Lists;Work

PROJECT_TITLE: Efficacy of a Virtual Reality Neuroscience-based Therapy for Chronic Low Back Pain


ADMINISTERING_IC: AR

IC_NAME: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

NIH_SPENDING_CATS: Assistive Technology;Bioengineering;Clinical Research;Physical Injury - Accidents and Adverse Effects;Physical Rehabilitation;Rehabilitation

ORG_CITY: EUGENE

ORG_NAME: PENDERIA TECHNOLOGIES, INC.

PHR: Narrative Current standards in postoperative orthopedic rehabilitation rely on extremely conservative estimates of patient progress to prevent repair failure despite overwhelming evidence that early loading of the injury is critical in regaining range of motion and strength. Conversely, over aggressive treatment programs can result in reinjury of the repaired tissue, leading to increased healthcare costs, prolonging the healing process, and resulting in poor outcomes. The proposed wireless implantable sensor system for rotator cuff repairs will allow patient- specific and evidence-based orthopedic care, which will result in a significant cost savings by reducing repair failures, reducing healing times, and providing improved patient outcomes.

PI_NAMEs: KARIPOTT, SALIL SIDHARTHAN (contact)

PROGRAM_OFFICER_NAME: WANG, XIBIN

PROJECT_TERMS: achilles tendon;Address;aggressive therapy;Articular Range of Motion;Biofeedback;biomaterial compatibility;Biomechanics;Bluetooth;bone;bone healing;Caring;clinic ready;Clinical;clinical application;commercialization;Complex;cost;Cost Savings;data exchange;design;Detection;detection test;Development;Devices;Early Diagnosis;effectiveness study;Ensure;Environment;Evaluation;evidence base;experience;experimental study;fabrication;Failure;Feedback;fitness;Frequencies;functional restoration;Funding;Goals;Grant;Guidelines;healing;Health Care Costs;Human;human subject;Implant;implanted sensor;improved;Incidence;Industry;Injury;injury and repair;Interdisciplinary Study;Joint structure of shoulder region;limb movement;Limb structure;Marketing;Measurement;mechanical properties;Mechanics;Medical;Medical Device;Modeling;Monitor;Motion;Operative Surgical Procedures;Optics;Orthopedics;Outcome;pain perception;Pain Threshold;Patient-Focused Outcomes;Patients;Performance;Persons;Phase;physical therapist;Physical therapy;Play;Population;post-operative rehabilitation;Postoperative Period;preference;prevent;Privatization;Process;Protocols documentation;prototype;reconstruction;Recovery;Recovery of Function;regenerative rehabilitation;rehabilitation strategy;Rehabilitation therapy;repaired;research clinical testing;Rotator Cuff;rotator cuff injury;rotator cuff tear;Safety;Second Look Surgery;sensor;Shoulder;Site;Small Business Innovation Research Grant;sterility testing;Surgeon;Surgical sutures;System;Techniques;Technology;Tendon Injuries;Tendon structure;Testing;Time;tissue repair;Training;treatment program;United States;United States National Institutes of Health;Variant;wearable device;wireless;wireless electronic;wireless implant;wireless sensor

PROJECT_TITLE: Real-time Feedback for Post-Operative Rehabilitation of Rotator Cuff Repairs using Wireless Force-Sensing Suture Anchors

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-S (13)]


NIH_SPENDING_CATS: Bioengineering;Clinical Research;Digestive Diseases;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Nanotechnology;Organ Transplantation;Prevention;Rare Diseases;Rural Health;Transplantation;Vector-Borne Diseases

ORG_CITY: Seattle

ORG_NAME: INBIOS INTERNATIONAL, INC.

ORG_STATE: WA

PHR: Chagas disease is caused by Trypanosoma cruzi and transmitted by an insect vector, congenitally, and via blood transfusion and organ transplantation in Latin America and within immigrant communities in the US. We propose to deliver the FDA- cleared InBios Chagas DetectTM Plus Ver 2 test suitable for use in CLIA- waived settings, as a first in its class product for point- of- care detection of infection, population screening and monitoring.

PI_NAMEs: RAYCHAUDHURI, SYAMAL X (contact)

PROGRAM_OFFICER_NAME: JOY, DEIRDRE A

PROJECT_TERMS: Acceleration;acute infection;Algorithms;Antibodies;antibody detection;Antigens;Award;Blood Transfusion;Central America;Central American;Chagas Disease;Chronic;Chronic Phase;Clinical;Clinical Research;Communities;Country;Cyclic GMP;Detection;Development;Diagnosis;diagnostic algorithm;Dryness;Early treatment;Europe;Feedback;flexibility;Formulation;Gastrointestinal Diseases;Generations;Goals;Gold;Grant;Heart Diseases;Immigrant community;Immunoassay;Immunoglobulin G;improved;Individual;Infection;innovation;Insect Vectors;Insecta;Lateral;Latin America;Liquid substance;manufacture;Marketing;meetings;Mexican Americans;Mexico;migration;Monitor;Morbidity - disease rate;nanoGold;next generation;Organ Transplantation;Outcome;Performance;Persons;Phase;point of care;point-of-care detection;Population;prevent;Proteins;prototype;rapid test;Reader;Recommendation;Risk;Rural Community;screening;Sensitivity and Specificity;Serology test;serosurveillance;South America;South American;Specificity;Testing;timeline;Training;transmission process;Trypanosoma cruzi;vector;vector-borne;waiver

PROJECT_TITLE: Development of Next-gen Chagas DetectTM Plus Rapid test for sensitive and specific diagnosis of Chagas disease

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 DCAI-B (13)]


NIH_SPENDING_CATS: Bioengineering;Genetics;Hematology;Regenerative Medicine;Stem Cell Research;Stem Cell Research - Nonembryonic - Non-Human

ORG_CITY: Los Angeles

ORG_NAME: UNIVERSITY OF SOUTHERN CALIFORNIA

PHR: Project Narrative: In this proposal, we will investigate how stem and progenitor cells interact in the bone marrow with other cells to produce blood. This research can help improve the diagnosis and treatment of many diseases including bone marrow failure, leukemia and lymphoma, and provide new insights into blood and immune cell regeneration. In addition, our findings can help improve the bone marrow transplantation and develop new treatment strategies in regenerative medicine.

PI_NAMEs: ELOWITZ, MICHAEL B;LU, RONG  (contact)

PROGRAM_OFFICER_NAME: HATTANGADI, SHILPA MANOHAR

PROJECT_TERMS: Adult;Aging;Bar Codes;Blood;Blood Cells;Bone Marrow;Bone Marrow Cells;Bone marrow failure;Bone Marrow Transplantation;Cardiovascular Diseases;Cell Communication;Cell Fate Control;cell regeneration;cell stroma;Cell surface;cell type;Cells;chronic liver disease;Clinical;Clone Cells;Communication;Complex;Computational algorithm;cytokine;Decision Making;Diagnosis;Disease;Engineering;experimental study;Exposure to;Gene Expression;Genetic;Goals;Hematology;Hematopoiesis;Hematopoietic;hematopoietic stem cell fate;Hematopoietic stem cells;Hemorrhage;Heritability;Homeostasis;Image;Immune;Immunology;improved;In Situ;in situ imaging;in vivo;Individual;Infection;Injury;innovation;insight;intercellular communication;Intrinsic factor;leukemia/lymphoma;Malignant Neoplasms;Maps;Memory;migration;multi-task learning;Mutagenesis;Natural regeneration;Nature;new technology;novel;novel therapeutic intervention;Optics;Play;Population;Positioning Attribute;preservation;Process;programs;Proliferating;Reaction;reconstruction;Recording of previous events;Regenerative Medicine;Regulation;Research;response to injury;Role;Signal Pathway;Signal Transduction;Source;stem;stem cell differentiation;stem cell population;stem cells;Structure;Study models;success;System;Techniques;Technology;Time;Tissue Engineering;tissue regeneration;Tissues;transcriptome;transcriptomic profiling;transcriptomics;Work

PROJECT_TITLE: A spatial view of hematopoietic regeneration dynamics in the bone marrow

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


ORG_CITY: BOULDER

ORG_NAME: ASPERO MEDICAL, INC.

PHR: PROJECT NARRATIVE To remove cancerous tissues in the esophagus and stomach without full surgery, most doctors in the US do not use the most effective technique because it is difficult with the medical devices that are currently available. This project is intended to design and test a new device that would make this technique easier. Broad adoption of this new device is expected to improve patient outcomes including overall survival and a lower risk of cancer recurrence.

PI_NAMEs: RENTSCHLER, MARK  (contact)

PROGRAM_OFFICER_NAME: LUNSFORD, DWAYNE

PROJECT_TERMS: Address;Adoption;cancer recurrence;cancer risk;Cancerous;Clinical;clinical practice;Colon;Colonoscopy;commercialization;Communication;Data;design;Development;Device or Instrument Development;Devices;Disadvantaged;Dissection;Duodenum;Electrosurgery;Endoscopes;Endoscopy;Esophagus;evidence base;Excision;experience;flexibility;Freezing;gastrointestinal;Grant;high risk;improved;in vivo;innovation;Intervention;Intuition;Large Intestine;Lesion;Link;Marketing;Medical;Medical Device;Mucous Membrane;Operative Surgical Procedures;Patient Care;patient population;Patient-Focused Outcomes;Perforation;Performance;Phase;Positioning Attribute;Preclinical Testing;premalignant;Preparation;Procedures;Progression-Free Survivals;Recording of previous events;Recurrence;Risk;Risk Reduction;Rotation;Safety;Site;Small Business Innovation Research Grant;Small Intestines;Stomach;Submucosa;Techniques;Technology;Testing;Texture;Time;Tissues;tool;Tube;Upper digestive tract structure;Validation;verification and validation;Work

PROJECT_TITLE: Balloon Overtube Access Device for Improved Interventional Endoscopy in the Upper GI

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-W (12)]


ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

ORG_CITY: IRVINE

ORG_NAME: ZYMO RESEARCH CORPORATION

PHR: PROJECT NARRATIVE Stroke injury occurs over a long duration through pathologic changes leading to long-term neurologic dysfunction. We have developed an IV Xe-liposomal formulation (XKS07), that provides stabilization of ischemic injury and reduced stroke death rate and neurological dysfunction. In this proposal, we will finalize clinically essential strategies allowing maximal stabilization of ischemic injury during acute ischemic stroke and ensure compatibility with reperfusion therapies, develop this formulation and strategy through toxicology studies for FDA pre-IND discussion, and proceed to the IND application.

PI_NAMEs: BOOHER, KEITH  (contact);HUANG, SHAOLING

PROGRAM_OFFICER_NAME: GILCHRIST, FLOY ANNETTE

PROJECT_TERMS: Acute;acute stroke;Address;Alteplase;Animals;Atrophic;Biological Markers;Blood;Blood flow;Brain;Brain hemorrhage;Brain Injuries;Cause of Death;cerebroprotection;Cerebrovascular system;Cessation of life;cGMP production;Clinical;Clinical Drug Development;Clinical Protocols;clinical translation;clinical trial protocol;Clinical Trials;clinically relevant;Cyclic GMP;Cytoprotection;Death Rate;design;disability;dosage;Dose;drug development;Drug Kinetics;Edema;efficacy study;Ensure;epigenetic marker;Epigenetic Process;experience;FDA approved;Feedback;Formulation;Future;global health;Goals;Health Sciences;Hemorrhage;Human;Infarction;Injury;Intravenous;ischemic injury;Ischemic Stroke;Lead;Life;liposomal formulation;Liposomes;Long term disability;long term recovery;manufacture;mathematical model;Maximum Tolerated Dose;Medical emergency;meetings;Middle Cerebral Artery Occlusion;Modeling;mortality;Neurologic Deficit;Neurologic Dysfunctions;No-Observed-Adverse-Effect Level;novel;Outcome;Pathologic;Pharmaceutical Preparations;pharmacokinetic model;Pharmacologic Substance;Pharmacology;Phase;Phase I Clinical Trials;physiologically based pharmacokinetics;Physiology;pre-clinical;pre-Investigational New Drug meeting;preclinical efficacy;Preparation;primary outcome;Protocols documentation;Quality Control;Recommendation;Reperfusion Therapy;Research;Research Contracts;secondary outcome;Small Business Technology Transfer Research;standard of care;Stroke;stroke model;stroke patient;stroke recovery;stroke therapy;System;Technology;Testing;Texas;Therapeutic;Thrombectomy;thrombolysis;Toxicology;translational model;Universities;Validation;Work;Xenon

PROJECT_TITLE: A Novel Xenon Delivery Platform for Cerebroprotection During Stroke


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

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

ORG_CITY: MONTROSE

ORG_NAME: HILLHURST BIOPHARMACEUTICALS, INC.

PHR: PROJECT NARRATIVE This proposal is intended to support research evaluating whether HBI-002, an oral low dose carbon monoxide (CO) drug product, can improve outcomes in animal models of cystic fibrosis. If successful, the project will provide proof-of-concept for further development of HBI-002 in treating cystic fibrosis as a promising therapeutic to improve outcomes in this devastating condition.

PI_NAMEs: BRUSCIA, EMANUELA MARINA;GOMPERTS, EDWARD  (contact)

PROGRAM_OFFICER_NAME: LACHOWICZ-SCROGGINS, MARRAH ELIZABETH

PROJECT_TERMS: Accidents;Acute;Acute Respiratory Distress Syndrome;Adult;Age Years;Animal Model;Animals;Anti-Inflammatory Agents;Binding;Biological Availability;Body Weight decreased;Carbon Monoxide;Chronic;Chronic Obstructive Pulmonary Disease;Clinical;clinical development;Clinical Research;Clinical Trials;clinically relevant;cost;Cystic Fibrosis;cystic fibrosis mouse;cystic fibrosis patients;Cystic Fibrosis Transmembrane Conductance Regulator;Data;Data Analyses;Defect;Development;Dose;Drug Kinetics;Enzymes;experience;Experimental Animal Model;Exposure to;follow-up;Gases;Genes;Goals;gut inflammation;Heme;heme oxygenase-1;Hereditary Disease;Homeostasis;Human Resources;immune function;Immune response;immunoregulation;improved outcome;in vivo;Individual;Infection;Inflammation;Inflammation Mediators;Inflammatory;Inhalation;Inhalation Exposure;Injury;innovation;Kinetics;Laboratories;Life;Life Expectancy;Lipopolysaccharides;Liquid substance;Literature;Lung;Lung infections;lung injury;Measures;Membrane;Methods;Modality;Modeling;Morbidity - disease rate;Mutation;neutrophil;Neutrophilia;novel;novel strategies;novel therapeutics;Oral;Pathologic;Patients;Persons;Pharmaceutical Preparations;Phase;Physiological;pre-clinical;preclinical efficacy;prevent;Privatization;Production;Proteins;Pseudomonas aeruginosa;Pseudomonas aeruginosa infection;Pulmonary Cystic Fibrosis;pulmonary function decline;Pulmonary Inflammation;Quality of life;Research;research clinical testing;Research Personnel;Research Support;Resolution;Respiratory physiology;response;Risk;Safety;Seasons;Stress;Structure of parenchyma of lung;Testing;Therapeutic;therapeutic development;Therapeutic Uses;therapeutically effective;Tissues;Toxic effect;Toxicology;Translations;Treatment Efficacy;ventilation

PROJECT_TITLE: HBI-002 for Cystic Fibrosis

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


NIH_SPENDING_CATS: Adolescent Sexual Activity;Behavioral and Social Science;Clinical Research;Contraception/Reproduction;Dissemination and Implementation Research;HIV/AIDS;Health Services;Infectious Diseases;Pediatric;Pediatric - AIDS;Prevention;Teenage Pregnancy;Women's Health Research

ORG_CITY: SEATTLE

ORG_DEPT: OBSTETRICS & GYNECOLOGY

ORG_NAME: UNIVERSITY OF WASHINGTON

PHR: PROJECT NARRATIVE Adolescent girls and young women (AGYW; age 15-24) in East Africa are disproportionately affected by poor sexual and reproductive health (SRH) outcomes, namely HIV acquisition and unintended pregnancy. In Kenya, despite increasing recognition of AGYW’s interrelated needs for HIV pre-exposure prophylaxis (PrEP) and family planning (FP) services, facility-based SRH programs struggle to reach at-risk AGYW; retail pharmacies are a promising venue for improving access these critical health services. This proposal leverages an ongoing pharmacy PrEP delivery cluster RCT among AGYW in Kisumu, Kenya to identify nuanced relationships between FP use and PrEP behaviors, and to evaluate the barriers and facilitators to implementing integrated FP and PrEP services in pharmacy settings.

PI_NAMEs: HARRINGTON, ELIZABETH K (contact)

PROGRAM_OFFICER_NAME: YATES, FRANKLIN WILLEM

PROJECT_TERMS: abortion;Address;Adherence;Affect;Africa;African;Age;AIDS prevention;avoid pregnancy;Behavior;Behavioral;care seeking;Caring;Clinic;cohort;Collaborations;Contraceptive methods;Counseling;Dapivirine;Data;design;Development;Educational workshop;effectiveness testing;Elements;emergency contraception;empowerment;Enrollment;Family dynamics;Family Planning;Female Adolescents;Future;future implementation;Gender;Goals;Guidelines;Health;Health care facility;Health Services;Health Services Accessibility;High Prevalence;HIV;human centered design;implementation research;implementation strategy;Improve Access;improved;Incidence;innovation;Interview;intimate partner violence;Kenya;Measures;Mental Depression;Methods;Modeling;multidisciplinary;novel;Nurses;Oral;Outcome;Participant;Pathway interactions;Pattern;Pharmacy facility;Positioning Attribute;pre-exposure prophylaxis;preference;Pregnancy;Prevalence;prevent;Prevention;prevention service;programs;psychosocial;Public Sector;Qualitative Evaluations;Quality of Care;Randomized;randomized, clinical trials;Recommendation;reproductive;Reproductive Health Services;Research;Research Personnel;Risk;Sampling;service delivery;Services;sexual and reproductive health;social stigma;sociodemographics;Southern Africa;synergism;Technology;Testing;Theoretical Domains framework;Time;Translating;unintended pregnancy;uptake;Vaginal Ring;Woman;Work;young woman

PROJECT_TITLE: Exploring synergies in pharmacy-based delivery of PrEP and contraception for adolescent girls and young women in Kenya

STUDY_SECTION: PPAH

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


NIH_SPENDING_CATS: Clinical Research;Clinical Trials and Supportive Activities;Drug Abuse (NIDA only);Emergency Care;Health Services;Opioids;Pain Research;Prescription Drug Misuse;Substance Misuse

ORG_CITY: NEW YORK

ORG_NAME: ADDINEX TECHNOLOGIES, INC.

ORG_STATE: NY

PHR: NARRATIVE The opioid epidemic continues to suffer from overprescribing, overuse, and lack of disposal. Based on successful results in a pilot study with post-surgical cancer patients, Addinex now proposes to adapt our medication control, monitoring, and disposal system for commercialization in a hospital setting by partnering with a hospital pharmacy and running a study of ambulatory patients being discharged after treatment for bone fractures. This intervention is designed to reduce misuse and diversion of post-surgical opioids by controlling access, providing clinician-derived automated feedback, and promoting disposal of unused pills without compromising pain control.

PI_NAMEs: ROSLYAKOV, STANISLAV  (contact)

PROGRAM_OFFICER_NAME: SABIRZHANOV, BORIS YEVGENYEVICH

PROJECT_TERMS: Academic Medical Centers;Accident and Emergency department;addiction;Adult;Aftercare;arm;Cancer Patient;Child;Client satisfaction;Clinical;Clinical Research;Clinical Trials;Code;Collaborations;commercialization;comparison control;Congresses;Consumption;Control Groups;cost;Custom;Data;design;Development;Dose;Education;Effectiveness;effectiveness evaluation;Emergency Department patient;Emergency Medicine;Emergency Situation;Ensure;Environment;Evaluation;Feasibility Studies;Feedback;Fracture;Friction;Future;Goals;Grant;Hospitals;improved;Individual;Institution;Intervention;intervention effect;intervention participants;Journals;Legal patent;Limb structure;Measures;Mechanics;Medical;Medical Device;Medicare;Medication Management;Minor;misuse of prescription only drugs;Monitor;non-opioid analgesic;Notification;novel;Oncology;operation;Operative Surgical Procedures;Opioid;Opioid Analgesics;opioid disposal;opioid epidemic;opioid mortality;opioid use;Orthopedics;overdose death;Pain;Pain management;Participant;Patient Monitoring;Patients;pediatric patients;Peer Review;Personal Satisfaction;Persons;Pharmaceutical Preparations;Pharmacists;Pharmacy facility;Phase;pill;Pilot Projects;Policies;Population;Postdoctoral Fellow;prescription opioid;prescription pain reliever;Procedures;Process;Protocols documentation;Publishing;Reporting;Research Personnel;response;Rhode Island;Running;satisfaction;Schedule;Secure;Services;smartphone application;Speed;Surveys;System;Technology;Testing;Time;treatment duration;Work;Writing

PROJECT_TITLE: Integration of an opioid dispensing, monitoring, and disposal platform with a hospital pharmacy to reduce opioid use by discharged emergency department patients


NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Cancer;Lung

ORG_CITY: SAN DIEGO

ORG_NAME: 3DT HOLDINGS, LLC

PHR: NARRATIVE The Tracheoesophageal (TE) Button market has lacked significant innovation and continues to utilize the same materials for the past 20 years. The goal of this Phase I proposal is to introduce significant innovations from better biocompatible materials and unique designs that can address most of the TE Button issues, including the discomfort and tissue irritation induced by the device.

PI_NAMEs: HUBBARD, TERRY  (contact);KASSAB, GHASSAN S

PROGRAM_OFFICER_NAME: TRIPURANI, SWAMY KRISHNA

PROJECT_TITLE: Novel Tracheostoma Device


ORG_CITY: ROCHESTER

ORG_NAME: PAVAJ VASCULAR CORPORATION

PHR: Project Narrative: In 2017, there were ~750,000 US patients with end-stage kidney disease (ESKD) who required chronic hemodialysis (HD). Venous stenosis (VS) forms in two thirds of the patients with arteriovenous fistulas needed for adequate HD. Pavaj Vascular is developing and commercializing a novel therapy that can prevent AVF VS.

PI_NAMEs: MILLER, AARON  (contact);MISRA, SANJAY

PROGRAM_OFFICER_NAME: CONAGE-POUGH, JASON EDWARD

PROJECT_TERMS: Address;Affect;Anatomy;Angioplasty;Animals;Apoptosis;Arteriovenous fistula;Biological;Biology;biomaterial compatibility;Biotechnology;Blood flow;Blood Vessels;Calcium;Cannulations;Caring;Certification;Cholecalciferol;Chronic;Chronic Kidney Failure;Clinic;Clinical;commercialization;Cost Savings;cytotoxicity;Data;Development;Dialysis procedure;Drug Delivery Systems;Drug Kinetics;effective therapy;Encapsulated;End stage renal failure;ERG gene;Evaluation;evidence base;Failure;Family suidae;first-in-human;Formulation;Frequencies;Gene Expression Profiling;Genes;Genetic Engineering;Glycolates;Goals;good laboratory practice;Good Manufacturing Process;Guidelines;Health Care Costs;Hemodialysis;Histologic;Homeostasis;Hormones;Hydrogels;Hypercalcemia;Hyperplasia;improved;Industry;Inflammation;innovation;interest;Interventional radiology;Investigational Drugs;Kidney Transplantation;Legal patent;Licensing;local drug delivery;Magnetic Resonance Imaging;Measures;Medical;Medical Device;Methods;Modeling;Morbidity - disease rate;Mus;nanoparticle;nanoparticle delivery;Needles;Nephrology;New Drug Approvals;novel therapeutics;Operative Surgical Procedures;optimal treatments;Oral Administration;Outcome;Pathway interactions;Patients;Peritoneal Dialysis;Pharmaceutical Preparations;Phase;Population;porcine model;prevent;Publishing;Radiology Specialty;Recurrence;Regulation;Renal Replacement Therapy;Research Institute;restenosis;Safety;safety assessment;Scientist;Signal Pathway;Signal Transduction;Small Business Innovation Research Grant;Specimen;Stenosis;Technology;Testing;therapeutic target;Thrombosis;Time;Tissue-Specific Gene Expression;Toxin;transcriptome sequencing;transcriptomics;Transplantation;Uremia;Veins;Venous

PROJECT_TITLE: Development of a Treatment to Improve Arteriovenous Fistula Function

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


NIH_SPENDING_CATS: Autoimmune Disease;Clinical Research;Clinical Trials and Supportive Activities;Psoriasis

ORG_CITY: LOS ANGELES

ORG_NAME: UNIVERSITY OF CALIFORNIA LOS ANGELES

PHR: PROJECT NARRATIVE There is a lack of treatment satisfaction instruments that validly measures patient experience with dermatological treatments. We propose to validate a dermatology-specific treatment satisfaction instrument that captures the treatment impact on skin signs and symptoms. Valid assessment of patients’ satisfaction with dermatological therapies will help inform shared decision-making between clinicians and patients, predict treatment adherence, improve the likelihood of long-term treatment success, and markedly impact the design of future dermatology therapeutic studies.

PI_NAMEs: ARMSTRONG, APRIL W (contact)

PROGRAM_OFFICER_NAME: UNDALE, ANITA H

PROJECT_TERMS: Adherence;Adverse effects;Affect;Behavior;California;care delivery;Chronic small plaque psoriasis;Client satisfaction;Clinical;clinical decision-making;clinical practice;Clinical Trials;Clinical Trials Design;cohort;Consensus;Dermatologic;Dermatology;design;Development;Effectiveness;Evaluation;experience;Flare;Future;Generations;Goals;improved;instrument;International;Interview;Measurement;Measures;medication compliance;Methodology;novel;optimal treatments;Outcome;Outcome Measure;Patient Outcomes Assessments;patient population;Patient-Centered Care;Patients;Pharmaceutical Preparations;Prediction of Response to Therapy;Process;prospective;Psoriasis;recruit;Reporting;Research;Research Personnel;Sampling;satisfaction;shared decision making;side effect;Signs and Symptoms;Skin;Structure;success;systematic review;Testing;therapeutic candidate;Therapeutic Studies;treatment adherence;Treatment outcome;treatment pattern;Treatment Protocols;United States National Institutes of Health;Work

PROJECT_TITLE: Assessment of Treatment Satisfaction in Psoriasis

STUDY_SECTION: AMSC

STUDY_SECTION_NAME: Arthritis and Musculoskeletal and Skin Diseases Clinical Trials Study Section [AMSC]


ADMINISTERING_IC: EY

IC_NAME: NATIONAL EYE INSTITUTE

NIH_SPENDING_CATS: Biotechnology;Eye Disease and Disorders of Vision;Gene Therapy;Genetics;Neurodegenerative;Neurosciences;Orphan Drug;Rare Diseases

ORG_NAME: OPUS GENETICS INC.

PHR: PROJECT NARRATIVE  Currently there is no FDA approved treatment for any form of autosomal-dominant retinitis pigmentosa and there is an urgent unmet medical need to develop effective therapies. Opus Genetics is developing OPGx-RHO, a single, mutation-independent, AAV-based gene therapy vector for the treatment of any autosomal-dominant retinitis pigmentosa that results from mutations in the rhodopsin gene. Having demonstrated efficacy and safety in a T4R-Rho mutant canine model, this proposal will seek confirmation of efficacy and safety in a second animal model, TgP23H pigs.

PI_NAMEs: YERXA, BENJAMIN R (contact)

PROGRAM_OFFICER_NAME: LEE, PAEK-GYU

PROJECT_TERMS: Acute;Affect;Alleles;Animal Model;autosome;Bilateral;Body Weight;canine model;Canis familiaris;Capsid;Chemistry;Clinical;Clinical Chemistry;Clinical Pathology;Clinical Treatment;Clinical Trials;Coagulation Process;Codon Nucleotides;Collaborations;Complementary DNA;Cone;Data;Dependovirus;Development;Devices;Dose;effective therapy;efficacy evaluation;Electroretinography;Elements;Euthanasia;Eye;Eye diseases;Family suidae;FDA approved;first-in-human;Functional disorder;gain of function;Gene Mutation;Gene Proteins;gene therapy;Gene Transduction Agent;Genes;Genetic;Health;Hematology;Human;human disease;Image;Immunohistochemistry;improved;in vivo;Inheritance Patterns;Inherited;Injections;innovation;knock-down;Lasers;Left;Licensing;Light;manufacture;Measures;Medical;meetings;method development;Microscopic;Modeling;Morphology;mortality;mutant;Mutation;neuronal cell body;neutralizing antibody;Night Blindness;novel;Nuclear;Operative Surgical Procedures;Optical Coherence Tomography;Pathology;Patients;Peripheral;Persons;Phase;Physical Examination;porcine model;postnatal;pre-Investigational New Drug meeting;Predisposition;preservation;Readiness;Recommendation;Replacement Therapy;Resistance;response;Retina;Retinal Cone;Retinal Dystrophy;retinal rods;Retinitis Pigmentosa;rho;Rhodopsin;Rod;Safety;safety study;Satellite Viruses;Scanning;Serotyping;sex;Side;small hairpin RNA;Spatial Distribution;Stimulus;Structure;Syringes;Technology;Therapeutic;Thick;Tissues;Toxic effect;Toxicology;Transgenic Organisms;treatment group;treatment strategy;Universities;vector;Vertebrate Photoreceptors;Viral;Viral Genome;Work

PROJECT_TITLE: A single mutation-independent AAV gene therapy for the treatment of autosomal-dominant retinitis pigmentosa.

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 NV-M (12)]


NIH_SPENDING_CATS: Assistive Technology;Behavioral and Social Science;Bioengineering;Brain Disorders;Cerebrovascular;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Complementary and Integrative Health;Disability Research;Networking and Information Technology R&D (NITRD);Neurosciences;Patient Safety;Physical Activity;Physical Injury - Accidents and Adverse Effects;Physical Rehabilitation;Rehabilitation;Stroke

ORG_CITY: NASHVILLE

ORG_NAME: HEALING INNOVATIONS INC

ORG_STATE: TN

PHR: Project Narrative In the U.S. over 5 million people are living with paralysis at an annual cost of over $200B to the healthcare industry, more than half of which is due to patients with a stroke diagnosis. Gait training is a critical part of rehabilitation for these individuals to help them regain mobility, reduce secondary health complications, and improve quality of life. A variety of barriers including high cost, limited access, and physical limitations can prevent opportunities for gait training, which is why Healing Innovations is developing a best-in-class gait trainer that is the first device to bring high-dose gait training into the home.

PI_NAMEs: HARTMAN, JULIE ;TAYLOR, BEN  (contact)

PROGRAM_OFFICER_NAME: AJISAFE, TOYIN DELE

PROJECT_TERMS: Adherence;American Stroke Association;arm;Blood Vessels;Body Weight;Bone Density;Cardiovascular system;Circulation;Clinic;Clinical;Clinical Trials;Communities;community engagement;comparison control;cost;cost effective;Data;design;Development;Device Designs;Devices;Diagnosis;Dose;efficacy outcomes;Electromagnetics;Equipment;Exercise;exercise program;Exercise Therapy;exoskeleton;Fall prevention;falls;Feedback;Fostering;FPS-FES Oncogene;Future;Gait;gait rehabilitation;Goals;Head;healing;Health;Healthcare Industry;Home;Home environment;Human;Impairment;improved;Incidence;Individual;individualized medicine;innovation;Inpatients;Interview;kinematics;Leg;lymphatic dysfunction;Manuals;Marketing;Measures;Medical;Medical Technology;meetings;mobile application;mobility aid;Motor;Movement;Muscle Spasticity;Muscular Atrophy;Nervous System Trauma;Neurologic;new technology;novel;Outcome;Paralysed;Patient Education;patient population;Patient-Focused Outcomes;Patients;Pattern;Persons;Phase;Physicians;prevent;programs;Protocols documentation;prototype;Quality of life;Recommendation;Rehabilitation Centers;Rehabilitation device;Rehabilitation therapy;rehabilitative care;Reporting;respiratory;Robotics;Safety;safety outcomes;Secondary to;Skin;Small Business Innovation Research Grant;Social Interaction;Software Design;software systems;Software Validation;Spinal cord injury;Stroke;stroke patient;stroke rehabilitation;stroke survivor;System;Techniques;Technology;Testing;Time;Training;Traumatic Brain Injury;treadmill;treatment as usual;Urinary tract infection;usability;walker;Walking;walking speed;Work

PROJECT_TITLE: Development of a novel, cost-effective gait training device utilized at home for the neurological patient population

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


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging

ORG_CITY: SANTA BARBARA

ORG_NAME: PHOTOTHERMAL SPECTROSCOPY CORP.

PHR: Project narrative Infrared spectroscopy serves as a vital tool in life sciences research, allowing scientists to delve into the intricate biomolecular structures and interactions, offering deeper insights into biological processes and potential breakthroughs in healthcare. Currently available instruments, however, lack either the spatial resolution and/or measurement speed to address many critical challenges in life science research. This project aims to develop and commercialize a breakthrough new multi- modal microscope product that will enable high resolution video rate chemical imaging and spectroscopy with expected profound impacts for life sciences research in areas including metabolism, cancer, and neurodegenerative diseases such as Alzheimer’s.

PI_NAMEs: PRATER, CRAIG  (contact)

PROGRAM_OFFICER_NAME: BARNES, CHARLES ASHLEY

PROJECT_TERMS: absorption;Address;Alzheimer's Disease;Area;automated analysis;Biological;Biological Process;Biological Sciences;Biomedical Research;Boston;Cells;cellular imaging;Chemicals;Classification;Color;commercialization;Computer software;Confocal Microscopy;detector;Development;Disease;Endocytosis;Engineering;Evaluation;Fluorescence;Fluorescence Microscopy;Goals;Government;Healthcare;Heterogeneity;high throughput analysis;Hour;Image;infrared microscopy;infrared spectroscopy;insight;instrument;interest;Label;Lasers;lipid biosynthesis;Lipids;live cell imaging;Malignant Neoplasms;Measurement;metabolic abnormality assessment;metabolic imaging;Metabolism;meter;Microscope;Molecular;Molecular Analysis;Monitor;Multimodal Imaging;multimodality;nanomedicine;National Institute of Biomedical Imaging and Bioengineering;Neurodegenerative Disorders;novel;operation;optical imaging;Optics;Performance;Persons;Pharmaceutical Preparations;Phase;Physiologic pulse;Population;prototype;Publications;Raman Spectrum Analysis;Research;Resolution;response;Sampling;Scanning;Scientist;Small Business Innovation Research Grant;Source;Spectrum Analysis;Speed;Structure;success;Surface;System;Techniques;Temperature;Testing;Tissues;tool;ultra high resolution;United States National Institutes of Health;Universities

PROJECT_TITLE: Video Rate Photothermal Infrared Spectroscopy (VR-PTIR)

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


NIH_SPENDING_CATS: Cancer;Digestive Diseases;Esophageal Cancer;Genetic Testing;Genetics;Prevention;Rare Diseases

ORG_CITY: BELLE MEAD

ORG_NAME: PRE-CANCER DIAGNOSIS, LLC

ORG_STATE: NJ

PHR: PROJECT NARRATIVE The incidence of esophageal adenocarcinoma (EAC) has increased 600-700% in North America last 2-3 decades. The single major risk factor for the development of EAC is Barrett’s esophagus (BE), which affects approximately 5.4% of the adult population in the USA. With current therapy, EAC only has 18% 5 year-survival rate due to late-stage diagnosis. This project will develop a methylation diagnostic kit to differentiate BE- progressing and BE-non-progressing patients, which can lead to personal surveillance strategies. For high-risk patients, the early intervention including endoscopic mucosal resection will prevent the BE progressing to EAC, which will decrease the incidence of EAC and increase the patient’s survival.

PI_NAMEs: ZHOU, ZHONGREN  (contact)

PROGRAM_OFFICER_NAME: ZANE, LINDA KARINE

PROJECT_TERMS: Address;Adult;Affect;Alleles;analytical method;Anxiety;Area Under Curve;Barrett Esophagus;Biological Markers;Case/Control Studies;Clinical;clinical database;clinical predictors;Clinical Trials;Computer software;cost;Data;Development;Diagnosis;diagnostic development;diagnostic panel;Diagnostic Reagent Kits;diagnostic technologies;Diagnostic tests;Differentiated Gene;Disease;DNA;DNA Methylation;DNA methylation profiling;Early Intervention;Early treatment;Endoscopy;Epigenetic Process;Epithelium;Esophageal Adenocarcinoma;Esophageal mucous membrane;Excision;experience;follow-up;Fright;Future;General Hospitals;Genes;high risk;Hypermethylation;improved;Incidence;Intestines;melting;Methods;Methylation;methylation biomarker;methylation testing;Modeling;Mucous Membrane;North America;novel;Pathogenesis;Patient-Focused Outcomes;Patients;Phase;Population;power analysis;predictive marker;premalignant;prevent;Procedures;Radiofrequency Interstitial Ablation;Receiver Operating Characteristics;Research;Resolution;Risk;Risk Factors;risk prediction;Role;Sampling;Sensitivity and Specificity;Specificity;surveillance strategy;Survival Rate;Techniques;Testing;Triage;tumor progression;tumorigenesis;United States;whole genome

PROJECT_TITLE: Development of a highly sensitive DNA hypermethylation-based kit to identify Barrett's esophagus patients at high risk of progressing to esophageal adenocarcinoma

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CDPT-V (13)]


NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Clinical Research;Lung;Pediatric;Sleep Research

ORG_CITY: LOUISVILLE

ORG_NAME: PGXL TECHNOLOGIES, LLC

ORG_STATE: KY

PHR: PROJECT NARRATIVE  Approximately 3% of children have obstructive sleep apnea (OSA), but many remain undiagnosed due to limited testing capabilities. Polysomnography tests (overnight sleep studies) are the primary method for diagnosis of OSA in children, but these tests are highly expensive, have limited throughput, and can be difficult to administer in children. PGXL Technologies is developing a rapid, sensitive, and cost-effective urine-based test for detection of OSA in children, which will support rapid, cost-effective screening.

PI_NAMEs: BURNS, CHRISTOPHER THOMAS (contact);VALDES, ROLAND

PROGRAM_OFFICER_NAME: DIXIT, SHILPY

PROJECT_TERMS: Academy;Adenoidectomy;Advanced Development;Affect;Algorithms;Antibodies;Apnea;Biological Assay;Biological Markers;biomarker panel;Child;Childhood;CLIA certified;Clinic;Clinical;clinical diagnostics;Clinical Research;Clinical Trials;clinically relevant;Collection;commercialization;cost;cost effective;design;Detection;detection test;Diagnosis;diagnosis standard;diagnostic algorithm;diagnostic development;Diagnostic Equipment;diagnostic platform;Diagnostic Procedure;Enzyme-Linked Immunosorbent Assay;experience;Frequencies;Future;Goals;Health;Home;Hypertension;Hypoxia;Immunoassay;Impaired cognition;improved;improved outcome;in-vitro diagnostics;indexing;Institutional Review Boards;Investments;Laboratories;Legal patent;Literature;Measures;Medicine;Methods;Multi-site clinical study;multiplex assay;Myocardial dysfunction;neurobehavioral;Neurocognitive Deficit;novel;Obstructive Sleep Apnea;Orosomucoid;Orthodontic;Patient Monitoring;Patient-Focused Outcomes;Patients;Phase;Physical Examination;Physicians;Polysomnography;Population;Prevalence;prospective;Prospective Studies;Proteins;prototype;rapid test;Recording of previous events;Reference Values;sample collection;Sampling;screening;Sensitivity and Specificity;sensor;Severities;Shipping;Site;Sleep;Sleep Apnea Syndromes;Sleep Disorders;Sleep disturbances;Snoring;Specific qualifier value;Specificity;Specimen;standard care;Stress;success;Supervision;System;systemic inflammatory response;Technology;Testing;Time;Tonsillectomy;UMOD gene;Urinary Kallikrein;Urine;urocortin;Validation

PROJECT_TITLE: UroMarker Test Panel for Obstructive Sleep Apnea


NIH_SPENDING_CATS: Cancer;Clinical Research;Clinical Trials and Supportive Activities;Dental, Oral, and Craniofacial Disease;Immunotherapy;Orphan Drug;Rare Diseases;Skin Cancer

ORG_CITY: PORTLAND

ORG_NAME: PROVIDENCE PORTLAND MEDICAL CENTER

PHR: Project Narrative More effective agents are critically needed for patients with advanced cancer because current therapies rarely cure metastatic disease. This proposal will test the hypothesis that the combination of a galectin-3 inhibitor (GR- MD-02; belapectin) plus checkpoint blockade (pembrolizumab) will result in enhanced response rates compared to pembrolizumab alone for patients with metastatic melanoma and head and neck squamous cell carcinoma. This strategy has the potential to improve immunotherapy efficacy, decrease side effects, and to create new options for patients with metastatic disease.

PI_NAMEs: CURTI, BRENDAN D (contact);REDMOND, WILLIAM L

PROGRAM_OFFICER_NAME: SONG, MIN-KYUNG H

PROJECT_TERMS: Advanced Malignant Neoplasm;anti-PD-1;anti-PD1 therapy;antitumor effect;Antitumor Response;Biopsy;cancer cell;candidate marker;CD8-Positive T-Lymphocytes;Cell Physiology;Cells;Clinical;clinical care;clinical development;clinical efficacy;Combination immunotherapy;Combined Modality Therapy;Data;Disease;disorder control;Double-Blind Method;effector T cell;efficacy evaluation;Environment;experience;Flow Cytometry;Frequencies;Funding;Galectin 3;Goals;Head and Neck Squamous Cell Carcinoma;Immune;immune checkpoint blockade;Immune signaling;Immune system;immune-related adverse events;Immunologic Monitoring;Immunologics;Immunosuppression;Immunotherapy;improved;Incidence;inhibitor;innovation;insight;Knowledge;Leukocytes;Malignant Neoplasms;Mediating;Melanoma;Metastatic Melanoma;Molecular;molecular marker;Monoclonal Antibodies;monocyte;Myeloid-derived suppressor cells;neoplastic cell;novel;objective response rate;Pathway interactions;Patient Care;Patients;PD-1 blockade;PD-1/PD-L1;pembrolizumab;Pharmaceutical Preparations;Phase;Phase I Clinical Trials;phase I trial;Phase II Clinical Trials;Phenotype;polarized cell;Population;potential biomarker;Prognostic Factor;programmed cell death ligand 1;programmed cell death protein 1;Proteins;Randomized;Regimen;Regulatory Pathway;Research;resistance mechanism;responders and non-responders;response;response biomarker;side effect;standard of care;Systemic Therapy;T cell response;T memory cell;T-Cell Activation;T-Lymphocyte;Testing;Time;tumor;tumor growth;Tumor Immunity;tumor microenvironment;tumor-immune system interactions;United States National Institutes of Health

PROJECT_TITLE: Phase II Clinical Development of Galectin-3 Inhibition and Anti-PD-1: Immune Monitoring and Tumor Response

STUDY_SECTION: CONC

STUDY_SECTION_NAME: Clinical Oncology Study Section[CONC]


ED_INST_TYPE: SCHOOLS OF ARTS AND SCIENCES

FUNDING_MECHANISM: TRAINING, INDIVIDUAL

NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Clinical Research;Mental Health;Pediatric

ORG_CITY: DURHAM

ORG_DEPT: PSYCHOLOGY

ORG_NAME: DUKE UNIVERSITY

PHR: PROJECT NARRATIVE When children feel like they do not belong, it increases their distress and their risk for later anxiety/depressive symptoms and drug use. Feelings of belonging can be undermined or strengthened by gossip (i.e., negative or positive talk about others), yet little is known about the origins of gossip in early childhood. The current proposal uses both experimental methods and naturalistic observations to identify the developmental genesis of gossip as well as the immediate and long-term effects of spreading gossip or being the target of gossip on children’s feelings of belonging and distress in peer groups, which is of critical importance to children’s social and psychological well-being.

PI_NAMEs: YUCEL, NAZLI MELTEM (contact)

PROGRAM_OFFICER_NAME: ESPOSITO, LAYLA E

PROJECT_TERMS: 7 year old;Acute;Address;Adolescent;Adult;Affect;Age;age group;Anxiety;boys;career;Child;Childhood;Chronic;Clinical Psychology;Code;Communication;Data;Data Set;depressive symptoms;Development;developmental psychology;Distress;Drug usage;early childhood;experience;Experimental Designs;experimental study;Feeling;Friends;Friendships;Genetic Transcription;Goals;Lead;Link;Literature;Long-Term Effects;Maps;Measures;member;Mental Health;Methods;Moral Development;novel;Pathway Analysis;peer;Peer Group;Play;Policies;programs;Research;Research Personnel;Risk;Schools;skills;social;Social Development;Social Network;social observations;Social Psychology;statistics;Testing;Training;Video Recording;Well in self;Work

PROJECT_TITLE: The Impact of Gossip on Children's Feelings of Belongingness

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-F16-L(20)L]


ADMINISTERING_IC: EB

FUNDING_MECHANISM: TRAINING, INSTITUTIONAL

IC_NAME: NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING

ORG_CITY: SAINT LOUIS

ORG_DEPT: RADIATION-DIAGNOSTIC/ONCOLOGY

ORG_NAME: WASHINGTON UNIVERSITY

ORG_STATE: MO

PHR: PROJECT NARRATIVE Biomedical imaging is key to unlocking the secrets of human health and disease, from the level of genes and proteins, to signaling pathways, to cells and tissues, and whole organisms--and ultimately to visualizing the effectiveness of therapies in action. The better imaging tools we develop, the greater our ability to treat disease and improve human health. To this end, the training of interdisciplinary imaging scientists is critical.

PI_NAMEs: CULVER, JOSEPH P (contact);O'SULLIVAN, JOSEPH A;SHOKEEN, MONICA

PROGRAM_OFFICER_NAME: GUTEKUNST, DAVID JOSEPH

PROJECT_TITLE: 21ST CENTURY IMAGING SCIENCES: GRADUATE STUDENT TRAINING


ED_INST_TYPE: ORGANIZED RESEARCH UNITS

NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Biomedical Imaging;Cancer;Cancer Genomics;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Complementary and Integrative Health;Digestive Diseases;Genetics;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Human Genome;Liver Disease;Microbiome;Nutrition;Obesity;Physical Activity;Prevention;Racial and Ethnic Minority Health Research;Social Determinants of Health

ORG_CITY: HONOLULU

ORG_NAME: UNIVERSITY OF HAWAII AT MANOA

ORG_STATE: HI

PHR: PROJECT NARRATIVE In past work, we demonstrated striking ethnic/racial disparities regarding propensity to accumulate fat intra- abdominally and in the strength of the association between obesity and cancer risk among the five racial/ethnic groups of the Multiethnic Cohort Study. We also demonstrated the feasibility of an intermittent energy restriction (IER) dietary intervention in a diverse population of Hawaii and the short-term effectiveness of IER in reducing intra-abdominal fat and modifying gut microbiome composition. We now propose an expanded, 24-week, randomized trial to compare IER to daily ER in reducing intra-abdominal fat and total body fat and in improving cancer-related biomarkers and gut microbiome functions, as well as to better understand behavioral predictors of adherence to IER.

PI_NAMEs: LE MARCHAND, LOIC  (contact);PARK, SONG-YI

PROGRAM_OFFICER_NAME: RISCUTA, GABRIELA

PROJECT_TERMS: Abdomen;abdominal fat;Accelerometer;actigraphy;active comparator;Adherence;adiponectin;Adult;Anthropometry;Asian;Behavior assessment;behavior prediction;Behavioral;Biological;Biological Markers;Blood;blood-based biomarker;Body fat;Body mass index;Body Weight;Body Weight decreased;Breast Cancer Risk Factor;cancer risk;Central obesity;Clinical;cohort;Cohort Studies;Conduct Clinical Trials;Consultations;DASH diet;Data;Diet;Diet Monitoring;Dietary intake;Dietary Intervention;Dietary Practices;dietary restriction;Dietitian;Disparity;dissemination research;Dual-Energy X-Ray Absorptiometry;East Asian;Eating;Effectiveness;ethnic difference;ethnic disparity;ethnic diversity;Ethnic Origin;Ethnic Population;Etiology;Expectancy;Fatty acid glycerol esters;Food;Frequencies;Future;General Population;good diet;group intervention;gut microbiome;gut microbiota;Hawaii;Health;healthy lifestyle;healthy weight;Heart;Hip region structure;IGFBP3 gene;improved;Insulin;Insulin-Like Growth Factor I;Intervention;Interview;Intra-abdominal;Leptin;lipid metabolism;Liver;Longevity;Magnetic Resonance Imaging;Malignant Breast Neoplasm;Malignant neoplasm of liver;Malignant Neoplasms;Measurement;Measures;Mediator;Mediterranean Diet;Metabolic;Metagenomics;microbial;microbiome composition;middle age;Modification;multi-ethnic;Native Hawaiian or Other Pacific Islander;new technology;non-alcoholic fatty liver disease;Obesity;Obesity associated cancer;obesity risk;Outcome;Pacific Islander;Participant;Phenotype;Physical activity;Play;Population;Population Heterogeneity;post intervention;Problem Solving;Production;Protocols documentation;Psychological reinforcement;psychosocial;Questionnaires;racial difference;racial disparity;racial population;Randomized;randomized trial;Recommendation;recruit;Reporting;Research;Risk;Risk Factors;Role;Safety;safety and feasibility;Self Efficacy;SHBG gene;Social support;Stimulus;Structure;systemic inflammatory response;Telephone;Testing;Time;Translational Research;Visceral;Visceral fat;Woman;Work

PROJECT_TITLE: Effects of Intermittent Energy Restriction on Intra-Abdominal Fat and the Gut Microbiome: A Randomized Trial


NIH_SPENDING_CATS: Brain Cancer;Brain Disorders;Cancer;Genetics;Neurosciences;Orphan Drug;Pediatric;Pediatric Cancer;Rare Diseases;Stem Cell Research;Stem Cell Research - Nonembryonic - Human

ORG_NAME: COLUMBIA UNIVERSITY HEALTH SCIENCES

PHR: PROJECT NARRATIVE These studies are focused on understanding the mechanisms underlying medulloblastoma, the most common malignant brain tumor in children. Successful completion will shed light on pathways required for tumor growth, identify novel therapeutic targets, and provide models to test therapies directed against these targets, enabling us to move them forward to the clinic.

PI_NAMEs: TAYLOR, MICHAEL D.;WECHSLER-REYA, ROBERT J. (contact);WEISS, WILLIAM A

PROGRAM_OFFICER_NAME: FINGERMAN, IAN M

PROJECT_TERMS: aggressive therapy;ATAC-seq;Automobile Driving;Brush Cell;Cells;Characteristics;Clinic;Clinical;Compensation;Complex;Core-Binding Factor;Cytoplasmic Granules;Data;Development;Disease;Engineering;Event;Genes;genetic corepressor;Genetic Transcription;GFI1 gene;Glutamates;Growth;high-throughput drug screening;histone demethylase;histone methyltransferase;Histones;Human;Immunocompromised Host;Impairment;improved outcome;In Vitro;in vivo;insight;Lip structure;Lysine;Malignant neoplasm of brain;Medulloblastoma;member;Modeling;Modification;Molecular;Monitor;Mus;Mutate;Mutation;Neuroepithelial;Neurons;new therapeutic target;novel;novel strategies;Oncogenes;Outcome;Pathway interactions;patient derived xenograft model;Patients;Pediatric Neoplasm;Polyproteins;Population;prevent;Process;progenitor;Reporter;Role;Route;SHH gene;side effect;single cell technology;single-cell RNA sequencing;small molecule;stem;stem cell fate;stem cells;Subgroup;Survivors;Testing;transcription factor;Transplantation;tumor;tumor growth;tumorigenesis

PROJECT_TITLE: Dysregulation of the Core Binding Factor Complex Inhibits Differentiation and Drives Group 4 Medulloblastoma

STUDY_SECTION: CNBT

STUDY_SECTION_NAME: Clinical Neuroimmunology and Brain Tumors Study Section[CNBT]


ADMINISTERING_IC: FD

IC_NAME: FOOD AND DRUG ADMINISTRATION

ORG_CITY: GAINESVILLE

ORG_NAME: UNIVERSITY OF FLORIDA

ORG_STATE: FL

PHR: Project Narrative Conduct a multicenter, open label Phase IIA trial of oral DCA in 40 surgical patients with recurrent GBM who have clinically indicated debulking surgery planned. Patients will be genotyped to establish safe dosing regimens and will be randomized to receive DCA (N=20) or no DCA (N=20) for one week prior to surgery, followed by all patients receiving DCA after surgery. Tumor tissue obtained at surgery will be assessed for phosphorylated PDC protein expression in tumor tissue.

PI_NAMEs: BETTEGOWDA, CHETAN ;GROSSMAN, STUART A;STACPOOLE, PETER WALLACE (contact)

PROGRAM_OFFICER_NAME: JOHNSON, LLOYD

PROJECT_TITLE: Phase IIA Trial of Dichloroacetate for Glioblastoma Multiforme, IND137007, 09172019


ADMINISTERING_IC: OD

IC_NAME: OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH

NIH_SPENDING_CATS: Aging;Bioengineering;Clinical Research;Data Science;Dental, Oral, and Craniofacial Disease;Eye Disease and Disorders of Vision;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Neurodegenerative;Neurosciences;Patient Safety;Precision Medicine;Prevention;Telehealth

ORG_CITY: LA JOLLA

ORG_DEPT: OPHTHALMOLOGY

ORG_NAME: UNIVERSITY OF CALIFORNIA, SAN DIEGO

PHR: PROJECT NARRATIVE A precision medicine approach is critical for early detection and treatment of glaucoma, an insidious chronic eye disease that can lead to blindness and severely decreased quality of life. The relationship between systemic conditions and treatments with glaucoma progression, as well as methods for monitoring and promoting glaucoma medication adherence, represent areas of glaucoma management that are not well-understood and are thus critical opportunities for technology-driven interventions. This study proposes the development and application of multi- modal health information technology innovations – such as machine learning-based predictive modeling, massive electronic datasets, wearable devices, and flexible sensor electronics – to enhance understanding of glaucoma pathophysiology and identify new potential therapeutic strategies.

PI_NAMEs: BAXTER, SALLY LIU (contact)

PROGRAM_OFFICER_NAME: MILLER, BECKY

PROJECT_TERMS: Accounting;Address;Adherence;Affect;African American population;Aging;All of Us Research Program;Area;Award;Big Data;biomedical informatics;Blindness;Blood Pressure;blood pressure regulation;Blood Vessels;Chronic;Chronic Disease;circadian regulation;Classification;Clinical;clinical phenotype;clinical practice;Clinical Research;cohort;comorbidity;cost;Counseling;Data;data integration;Data Science;Data Set;Dedications;Department chair;Development;Devices;Disease;Disease Management;Disease Progression;Early Diagnosis;early onset;Early treatment;electronic data;electronic health data;Electronic Health Record;electronic sensor;Electronics;Ensure;Exhibits;experience;Eye;Eye diseases;Eyedrops;faculty community;Fellowship;flexibility;flexible electronics;Foundations;Functional disorder;Future;Glaucoma;health information technology;Home;Home Blood Pressure Monitoring;Human Resources;Hypertension;Image;improved;Individual;Informatics;innovation;Institution;Intervention;Investigation;Latino Population;Leadership;Machine Learning;machine learning prediction;Measurement;Measures;medication compliance;Mentors;Methods;Modeling;Monitor;Morbidity - disease rate;multidisciplinary;multimodality;Nerve Degeneration;new therapeutic target;novel;novel therapeutic intervention;Operative Surgical Procedures;Ophthalmologist;Ophthalmology;Optic Nerve;Outcome;Participant;Patient Care;patient engagement;Patient Self-Report;Patient-Focused Outcomes;Patients;personalized management;Persons;Pharmaceutical Preparations;Physical activity;Pilot Projects;Population;precision medicine;Predictive Analytics;predictive modeling;Predictive Value;professor;programs;Public Health;Public Health Informatics;Qualifying;Quality of life;racial minority;Research;Resources;Risk;risk prediction model;risk stratification;Role;sensor;sensor technology;Sleep;smart watch;Symptoms;Techniques;technological innovation;Technology;Testing;Therapeutic;Time;Track and Field;Training;United States National Institutes of Health;Vision;Visual Fields;wearable device;Work

PROJECT_TITLE: Multi-modal Health Information Technology Innovations for Precision Management of Glaucoma

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