ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

NIH_SPENDING_CATS: Neurosciences

ORG_CITY: ATLANTA

ORG_DEPT: ANATOMY/CELL BIOLOGY

ORG_NAME: EMORY UNIVERSITY

PHR: PROJECT NARRATIVE: Proper wiring of the brain’s neuronal circuits is critical for development and a key step in this process is axon guidance, during which the highly motile tip of axons, called a growth cone, can sense and respond to extracellular guidance cues to find target cells. The ability of growth cones to sense external cues is dependent on actin-based structures called filopodia, which are formed by actin bundling proteins, primarily Fascin1. Errors in axon guidance as well as irregularities in Fascin1 expression levels have both been linked to epilepsy.

PI_NAMEs: HARDIN, KATHERINE REBECCA (contact)

PROGRAM_OFFICER_NAME: MATTHEWS, MARGUERITE

PROJECT_TERMS: Actins;Adult;autism spectrum disorder;Axon;axon growth;axon guidance;axonal pathfinding;Biological Assay;Biological Models;Brain;Brain Diseases;Bundling;Cell Culture Techniques;cell motility;Cells;Central Nervous System;CRISPR/Cas technology;Cues;Cultured Cells;Cytoskeleton;Data;Defect;Development;Developmental Process;Drosophila genus;Embryonic Development;Environment;Epilepsy;extracellular;F-Actin;fascin;Fiber;Filament;Filopodia;Fingers;fly;Genes;Genetic;Growth Cones;Hippocampus;Image;Imaging Techniques;in vivo;insight;Knock-out;Knowledge;Label;Link;Lobe;Membrane;Memory;Microfilaments;migration;Modeling;Molecular;Molecular and Cellular Biology;Molecular Biology;Morphology;Motility;Movement;Mushroom Bodies;mutant;Nervous System Disorder;neural network;neuronal circuitry;Neurons;Olfactory Learning;Orthologous Gene;pharmacologic;Phosphorylation;Process;protein crosslink;Protein Kinase C;Proteins;Rattus;receptor;Regulation;response;RNA Interference;Role;Sampling;Sensory;Side;Signal Transduction;spatiotemporal;Structure;System;Testing;Training;training opportunity;Work

PROJECT_TITLE: Fascin1 in Growth Cone Motility and Guidance


ADMINISTERING_IC: VA

ARRA_FUNDED: N

FUNDING_MECHANISM: OTHERS

IC_NAME: Veterans Affairs

ORG_CITY: PROVIDENCE

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: PROVIDENCE VA  MEDICAL CENTER

ORG_STATE: RI

PI_NAMEs: BARREDO, JENNIFER LEIGH (contact)

PROJECT_TERMS: Age;Anatomy;Area;Award;Basal Ganglia;Basic Science;Behavior;Behavior Therapy;Behavioral;Bioinformatics;Biological;Biological Markers;biomarker identification;brain behavior;career;Cessation of life;Clinical;clinical care;clinical development;Clinical Sciences;Cognition;Cognitive;cognitive capacity;cognitive control;cognitive function;combat;combat veteran;Competence;Corpus striatum structure;Data;Data Set;Decision Making;Dedications;Depressed mood;Development;Diagnostic;Diffusion;discounting;Effectiveness;electronic health data;Electronic Health Record;Evaluation;Expectancy;Feeling suicidal;Foundations;Functional disorder;Functional Magnetic Resonance Imaging;Funding;Future;Goals;gray matter;Health Sciences;high risk;high risk population;Hospitalization;Image;imaging study;Impaired cognition;improved;Impulsivity;Individual;Informatics;innovation;insight;interdisciplinary approach;Intervention;K-Series Research Career Programs;Knowledge;Lateral;Lead;Learning;Life;Machine Learning;machine learning algorithm;machine learning method;machine learning model;Magnetic Resonance Imaging;Measures;Mentors;Mentorship;Methodology;Methods;military veteran;Mission;morphometry;multimodal neuroimaging;neural correlate;Neurobiology;Neurocognitive;neuroimaging;neuroregulation;Neurosciences;novel;Older Population;Participant;Patient Self-Report;Persons;Population;Positioning Attribute;predictive modeling;predictive tools;preference;Prefrontal Cortex;prevent;Prevention;Process;programs;Psychiatric Diagnosis;Psychological reinforcement;Publishing;Qualifying;Recording of previous events;Research;Rest;Reversal Learning;reward circuitry;Rewards;Risk;Risk Assessment;Risk Factors;Risk Marker;Sampling;Scientist;screening;Self-Injurious Behavior;Services;Severities;sex;Signal Transduction;skills;Specialist;Structure;Subgroup;suicidal;suicidal behavior;suicidal individual;suicidal morbidity;suicidal risk;Suicide;Suicide attempt;suicide model;suicide rate;System;Task Performances;Testing;Time;Training;Translating;Veterans;Vision;Work

PROJECT_TITLE: Identification of Veterans at-risk for Suicide: a Multidisciplinary Approach


FUNDING_MECHANISM: NON-SBIR/STTR RPGS

ORG_CITY: MATHER

ORG_NAME: VA NORTHERN CALIFORNIA HEALTH CARE SYS

ORG_STATE: CA

PHR: Thousands of Veterans suffer a stroke every year, and these individuals often suffer emotional and cognitive changes that negatively affect their quality of life as well as their ability to recover. In addition to traditional rehabilitation such as physical and occupational therapy, a number of alternative treatments are now being studied for their ability to enhance patients’ recovery following stroke. One of these treatments, Mindfulness-Based Stress Reduction or MBSR, involves an 8-week course that teaches individuals strategies such as breathing techniques, meditation, and movement therapy. The current study proposes to teach MBSR to a group of Veterans with a history of stroke to determine whether this type of intervention has beneficial effects on psychological and cognitive functioning. We hope to find that MBSR is a useful, additional intervention that can improve Veterans’ well-being and quality of life as they recover from stroke.

PI_NAMEs: BALDO, JULIANA V. (contact)

PROJECT_TERMS: active comparator;active control group;Acute;Address;Affect;Alternative Therapies;alternative treatment;American;Anxiety;anxiety symptoms;Area;Attention;Awareness;Blinded;Blood Vessels;brain health;Brain Injuries;Brain region;Breathing;Caring;Chronic;Chronic Phase;chronic stroke;Clinical;Cognitive;cognitive change;cognitive function;cognitive performance;cognitive task;cognitive testing;comparison group;Control Groups;Coping Skills;cost;daily functioning;Data;depressive symptoms;disability;Disease;Educational process of instructing;Emotional;Evaluation;Event;evidence base;follow up assessment;follow-up;Future;Goals;Hour;Impaired cognition;improved;Individual;Injury;innovation;Instruction;instructor;Intervention;Left;Lesion;Literature;Location;Longterm Follow-up;Magnetic Resonance Imaging;Maps;Measures;Meditation;Mental Depression;military veteran;mindfulness-based stress reduction;Movement;Music Therapy;neural correlate;Neuropsychology;novel strategies;Occupational Therapy;Outcome Measure;Participant;Patients;Performance;Personal Satisfaction;Phase;Physical therapy;Pilot Projects;Play;post intervention;predicting response;Prediction of Response to Therapy;predictive marker;Prefrontal Cortex;primary outcome;psychologic;Publishing;Quality of life;Questionnaires;Randomized;Randomized Controlled Clinical Trials;randomized, clinical trials;randomized, controlled study;Randomized, Controlled Trials;Recording of previous events;Recovery;recruit;reduce symptoms;Rehabilitation therapy;Research;Resources;Risk;Risk Reduction;Role;secondary outcome;Short-Term Memory;Site;Standardization;stress reduction;stress symptom;Stroke;stroke patient;symptomatology;Symptoms;System;Teacher Professional Development;Techniques;Testing;Time;Training;treatment group;treatment risk;Veterans;Well in self;Work;Yoga

PROJECT_TITLE: Mindfulness-Based Stress Reduction to Improve Neuropsychological Functioning in Acquired Brain Injury

STUDY_SECTION_NAME: Behavioral Health & Social Reintegration[RRD4]


ADMINISTERING_IC: EY

ED_INST_TYPE: BIOMED ENGR/COL ENGR/ENGR STA

FUNDING_MECHANISM: TRAINING, INDIVIDUAL

IC_NAME: NATIONAL EYE INSTITUTE

NIH_SPENDING_CATS: Aging;Bioengineering;Biomedical Imaging;Eye Disease and Disorders of Vision;Neurodegenerative;Neurosciences

ORG_CITY: Chicago

ORG_DEPT: BIOMEDICAL ENGINEERING

ORG_NAME: NORTHWESTERN UNIVERSITY

ORG_STATE: IL

PHR: Project Narrative: Treatment of glaucoma, the leading cause of irreversible blindness, centers around intraocular pressure management. Outflow of aqueous humor through the conventional outflow pathway regulates intraocular pressure, but it remains difficult to assess the physiology of the pathway noninvasively. This project investigates the usage of visible-light optical coherence tomography to 1) obtain anatomical information about the pathway and 2) assess the functional status of outflow pathway for the purpose of optimizing glaucoma management.

PI_NAMEs: FANG, RAYMOND  (contact)

PROGRAM_OFFICER_NAME: AGARWAL, NEERAJ

PROJECT_TERMS: 3-Dimensional;anatomic imaging;Anatomy;Angiography;Anterior;anterior chamber;aqueous;Aqueous Humor;Autopsy;Behavior;Biological Markers;Biomedical Engineering;Biophotonics;Blindness;Blood flow;Blood Vessels;Clinical;clinical care;Clinical Medicine;contrast imaging;Data;density;design;Development;Diameter;digital;Dimensions;Distal;Doctor of Philosophy;effective therapy;Effectiveness;Environment;Eye;eye chamber;Foundations;Frequencies;Functional Imaging;functional status;Glaucoma;glaucoma surgery;Goals;graph theory;Height;Heterogeneity;Human;Image;imaging modality;Imaging technology;improved;in vivo;Individual;innovative technologies;Intervention;Investigation;Light;Machine Learning;Maps;mathematical model;Measurement;Measures;mechanical properties;Mentors;meter;Methods;minimally invasive;Modeling;Motion;Mus;non-invasive imaging;Operating Rooms;Optical Coherence Tomography;optimal treatments;Pathway interactions;Pattern;Pharmaceutical Preparations;pharmacologic;Phase;Physicians;Physiologic Intraocular Pressure;Physiological;Physiology;Pilocarpine;Predisposing Factor;pressure;Procedures;Property;Publishing;Research;Research Personnel;Resistance;Resolution;response;retinal imaging;Rodent;Sampling;Scheme;Structure;Structure of sinus venosus of sclera;Structure-Activity Relationship;System;technical report;Testing;Three-Dimensional Imaging;Tissues;tool;Trabecular meshwork structure;Tracer;Training;Translating;Treatment Effectiveness;treatment strategy;Variant;Veins;Visible Radiation;Visualization;Width;Work

PROJECT_TITLE: Anatomical and functional imaging of the conventional outflow pathway


ADMINISTERING_IC: DK

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Digestive Diseases;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Nutrition;Obesity;Prevention

ORG_CITY: Boston

ORG_NAME: SYNTIS BIO INC

ORG_STATE: MA

PHR: NARRATIVE Obesity is a global disease with significant healthcare spending and co-morbidities, highlighting the need for effective, non-invasive, and affordable weight loss solutions. Roux-en-Y gastric bypass surgery (RYGB) the gold standard for weight loss, but is limited by its high cost and procedural risks. Syntis Bio has created a gastrointestinal synthetic epithelial lining (GSEL) that is orally administered and transiently blocks nutrient absorption in the small intestine, thereby safely mimicking the effects of RYGB. This project aims to further develop the GSEL as an effective, safe, and affordable therapeutic weight loss intervention.

PI_NAMEs: SETHURAMAN, VASU  (contact)

PROGRAM_OFFICER_NAME: LUNSFORD, DWAYNE

PROJECT_TERMS: absorption;access disparities;Adoption;Animals;Area;bariatric surgery;Biological Assay;Blood Glucose;Body Weight decreased;Buffers;capsule;Cardiovascular Diseases;Cells;Chronic;Clinical;comorbidity;Complex;cost;crosslink;Dehydration;density;Deposition;Development;Devices;Diabetes Mellitus;Disease;Dosage Forms;Duodenum;efficacy testing;Engineering;Enteral;Enzymes;Epithelium;Equilibrium;Exclusion;experimental study;Exposure to;Family suidae;Fasting;Film;first-in-human;Formulation;Gastric Emptying;gastrointestinal;Glucose;Goals;Health Services Accessibility;Healthcare;Hormonal;Hour;Human;human study;in vivo;in vivo Model;Lead;Licensing;Liquid substance;Malignant Neoplasms;Malnutrition;manufacture;Metabolic Pathway;Modeling;nanoparticle;novel;Nutrient;nutrient absorption;Obesity;OGTT;Oral;Oral Administration;Oral Ingestion;Permeability;Pharmacotherapy;Phase;pill;porcine model;Powder dose form;Preparation;prevent;Property;Protocols documentation;radiological imaging;Residencies;Risk;Risk Factors;Safety;Signal Transduction;Small Business Innovation Research Grant;Small Intestines;socioeconomics;Solid;Source;Stomach;success;tablet formulation;Tablets;Technology;Testing;Therapeutic;Time;Tissues;Toxic effect;weight loss intervention;Work

PROJECT_TITLE: Development of an Oral Pill to Mimic the Effects of Gastric Bypass Surgery

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


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease Related Dementias (ADRD);Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Bioengineering;Biomedical Imaging;Brain Disorders;Clinical Research;Dementia;Frontotemporal Dementia (FTD);Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Neurodegenerative;Neurosciences;Orphan Drug;Parkinson's Disease;Precision Medicine;Rare Diseases

ORG_CITY: GAINESVILLE

ORG_NAME: AUTOMATED IMAGING DIAGNOSTICS, LLC

ORG_STATE: FL

PHR: NARRATIVE The growth rate in the number of people diagnosed with Parkinsonism is substantial, and misdiagnosis between forms of Parkinsonism is surprisingly high. Since the type of medication, disease progression, and level of disability can differ between types of Parkinsonism, obtaining an accurate diagnosis is essential for patient care and reducing healthcare costs. Automated Imaging Diagnostics is developing neuropacs™, a high-throughput brain image processing and AI-powered precision diagnostic tool. This Phase II project will further our efforts to develop a high-precision clinical decision support tool for Parkinsonism and position the company to achieve FDA approval milestones.

PI_NAMEs: BARMPOUTIS, ANGELOS  (contact)

PROGRAM_OFFICER_NAME: AUBRECHT, TARYN GRACE

PROJECT_TERMS: accurate diagnosis;Affect;Artificial Intelligence;atypical parkinsonism;Autopsy;Biological Markers;Board Certification;Brain imaging;cerebral atrophy;Classification;clinic ready;Clinical;clinical decision support;clinical diagnosis;clinical practice;clinical trial readiness;Clinical Trials;Computer software;Contrast Media;dashboard;Data;Data Set;Dementia;dementia risk;design;Devices;Diagnosis;Diagnostic;diagnostic accuracy;diagnostic biomarker;Diagnostic Imaging;diagnostic tool;Diffusion;Diffusion Magnetic Resonance Imaging;disability;Disease;disease diagnosis;Disease Progression;Dopamine;Evaluation;Florida;Goals;Growth;Health Care Costs;illness length;Image;image processing;imaging modality;improved;in vivo;individualized medicine;Internet;Letters;Libraries;Machine Learning;Magnetic Resonance Imaging;Marketing;Medical;Medical History;Meta-Analysis;Modeling;Motor;Movement Disorders;Multiple System Atrophy;Nerve Degeneration;Neurologist;Online Systems;Parkinson Disease;Parkinsonian Disorders;Pathologic;Pathology;Patient Care;Patients;Performance;performance tests;personalized diagnostics;personalized medicine;Persons;Pharmaceutical Preparations;Phase;Play;Positioning Attribute;prediction algorithm;Preparation;Probability;Prognosis;programs;Progressive Supranuclear Palsy;Qualifying;Quality of life;radiotracer;Reader;Records;recruit;Reporting;research clinical testing;Role;Scanning;Secure;Small Business Technology Transfer Research;Specialist;Standardization;Stroke;support tools;System;Techniques;Technology;Testing;timeline;tool;Translating;Traumatic Brain Injury;treatment planning;treatment strategy;Universities;Validation;Variant;Water;web app

PROJECT_TITLE: Clinical performance testing of neuropacs in Parkinsonism diagnosis

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


NIH_SPENDING_CATS: Bioengineering;Clinical Research;Clinical Trials and Supportive Activities;Diabetes;Disability Research;Prevention;Telehealth;Wound Healing and Care

ORG_CITY: CHARLOTTESVILLE

ORG_NAME: BARRON ASSOCIATES, INC.

ORG_STATE: VA

PHR: Project Narrative Products resulting from this grant will provide a multifaceted management/early warning system for preventing diabetic foot ulcers and their recurrence. SoleSaver sensor data, measured continuously in the patient’s free- living environment, will be used to: (1) identify early potential formation of a DFU to enable prompt and timely intervention (e.g., offloading); (2) quantify gait abnormalities and changes to gait that could result in a DFU; (3) ascertain peripheral arterial disease (PAD) status and changes thereto over time; (4) determine patterns of adherence to prescribed footwear; (5) quantify shear pressure in different areas of the plantar surface (both high impulse pressure and lower cumulative pressures) to issue alerts and enable expeditious offloading; (6) facilitate fabrication of custom footwear and; (7) assist in evaluating the effectiveness of custom footwear and other interventions in reducing plantar stresses and the formation of DFU. Additionally, SoleSaver can be used in clinical trials and other research to better understand the conditions that lead to DFU and the effect of new treatments.

PI_NAMEs: CLARK, BRIAN R (contact)

PROGRAM_OFFICER_NAME: LI, YAN

PROJECT_TERMS: Acute;Adherence;Adult;Age;American;Amputation;Ankle;Area;Caregivers;Categories;Cells;Cellular Phone;Cessation of life;Charge;Child;Chronic Disease;Clinic Visits;Clinical;Clinical Research;Clinical Trials;cloud based;Color;Communication;Complication;Computer software;Correlation Studies;cost;Custom;dashboard;Data;Data Storage and Retrieval;design;Development;Devices;Diabetes Mellitus;diabetic;Diabetic Foot Ulcer;Diagnosis;disability;Early identification;Economic Burden;effectiveness evaluation;efficacy evaluation;Environment;Epidemic;ergonomics;Evaluation;experimental study;fabrication;Feedback;flexibility;follow-up;foot;Freedom;Gait;Gait abnormality;Goals;Grant;Growth;Health;Healthcare;High Prevalence;Hospitalization;improved;Incidence;indexing;innovation;Intervention;Light;Maps;Measurement;Measures;Medical Care Costs;Methodology;Microprocessor;miniaturized device;Monitor;Non-Insulin-Dependent Diabetes Mellitus;Office Visits;Participant;Patient Monitoring;Patients;Pattern;Peripheral arterial disease;Peripheral Nervous System Diseases;Persons;Phase;phase 2 study;Photoplethysmography;portability;pressure;Prevalence;prevent;Prevention;Process;programs;prototype;Provider;Public Health;Quality of life;Recurrence;remote grading;Reporting;Research;research and development;Resistance;Risk Factors;Secure;sensor;sex;Shock;Small Business Innovation Research Grant;smartphone application;socioeconomics;Stress;Summary Reports;Surface;System;telehealth;Temperature;Time;Trauma;trend;Unsteady Gait;usability;Weight-Bearing state;wireless;wireless communication

PROJECT_TITLE: A system to enhance prevention of diabetic foot ulcers and their recurrence

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


ADMINISTERING_IC: AG

ED_INST_TYPE: OTHER SPECIALIZED SCHOOLS

FUNDING_MECHANISM: OTHER RESEARCH-RELATED

IC_NAME: NATIONAL INSTITUTE ON AGING

ORG_CITY: Los Angeles

ORG_NAME: UNIVERSITY OF SOUTHERN CALIFORNIA

PHR: Project Narrative In this project, we will determine whether plasma transfer approaches can reverse age-related epigenomic changes in microglia and identify genomic sites that could be targeted for mechanistic functional studies. We will also use single-cell molecular phenotypes, cell-specific translatomes, and microglia functional assays to characterize the dynamics of microglia populations in obesity and provide insights into aging- and obesity- associated neuroinflammation. Our long-term goal is to contribute mechanistic insights and knowledge into microglia aging and neuroinflammation and to develop novel strategies to promote healthy brain aging.

PI_NAMEs: ANSERE, VICTOR AFRIYIE (contact)

PROGRAM_OFFICER_NAME: HAAKENSON, CHELSEA MARIE

PROJECT_TERMS: Address;Affect;Affinity Chromatography;Age;age group;age related;age related changes;Aging;aging brain;Animals;anti aging;Applied Skills;Bioinformatics;Biological Assay;Biology;bisulfite sequencing;Blood Volume;BODIPY;Brain;Caloric Restriction;career;Cell Nucleus;cell type;Cells;chemokine;Communication;cytokine;Data;design;Development;diet-induced obesity;dietary;Disease;DNA;DNA Methylation;DNA Modification Process;Elements;Enhancers;Epigenetic age;epigenetic aging;epigenetic clock;Epigenetic Process;epigenome;epigenome editing;epigenomics;experience;Fatty acid glycerol esters;Fluorescence-Activated Cell Sorting;Foundations;functional decline;Functional disorder;Future;Gene Expression;Genes;Genomics;Goals;Grant;Heterogeneity;High Fat Diet;Hippocampus;immune activation;Impairment;improved;Inflammation;Inflammatory;innovation;insight;interest;Intervention;Knowledge;Laboratories;laboratory experience;late life;Lipids;Macrophage;Maintenance;Manuscripts;Mentors;Messenger RNA;Methylation;Microglia;Modeling;Molecular;molecular phenotype;Morphology;mouse model;Mus;Neurodegenerative Disorders;neuroinflammation;novel strategies;Nuclear;Nutritional;Obese Mice;Obesity;old mice;Operative Surgical Procedures;Oral;Pathologic;Pattern;Phagocytes;Phase;Phenotype;Physiological;Plasma;Population;prevent;Rejuvenation;Research;response;Ribosomes;RNA;Role;Saline;Scientist;sex;single-cell RNA sequencing;Site;skills;Sorting;Structure;systemic inflammatory response;Technical Expertise;Techniques;Technology;Testing;Thinness;Tissues;Training;transcriptome sequencing;transcriptomics;Translating;translational study;translatome;uptake;whole genome;Writing

PROJECT_TITLE: Reversing age-related epigenetic changes and characterizing microglia heterogeneity in obesity and aging


ADMINISTERING_IC: CA

ED_INST_TYPE: SCHOOLS OF MEDICINE

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Cancer;Emerging Infectious Diseases;HIV/AIDS;Infectious Diseases;Lymphatic Research;Rare Diseases

ORG_CITY: CHICAGO

ORG_DEPT: MICROBIOLOGY/IMMUN/VIROLOGY

ORG_NAME: NORTHWESTERN UNIVERSITY AT CHICAGO

PHR: PROJECT NARRATIVE Kaposi’s Sarcoma-associated herpesvirus (KSHV) is a major cause of AIDS-associated cancers and thus represents a significant public health burden. The proposed work seeks to establish and characterize an improved cell-based in vivo model for the KSHV-associated cancer, Kaposi’s Sarcoma. Results will be impactful, because they will strongly improve our ability to study mechanisms underlying Kaposi’s Sarcoma and to develop therapeutic strategies for this cancer.

PI_NAMEs: GOTTWEIN, EVA HENRIETTE (contact)

PROGRAM_OFFICER_NAME: READ-CONNOLE, ELIZABETH LEE

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;AIDS related cancer;Biological Markers;Blood Vessels;Cell Culture Techniques;Cell Proliferation;Cell Survival;cell type;Cells;Contact Inhibition;CRISPR screen;CRISPR/Cas technology;Data;experimental study;Fibrous capsule of kidney;Gene Expression;Genes;Gentian Violet;Herpesviridae Infections;Histology;Human;Human Herpesvirus 8;human imaging;Immunodeficient Mouse;Implant;implantation;improved;In Vitro;in vivo;in vivo Model;Infection;innovation;insight;Kaposi Sarcoma;Knock-out;Left;Lymphatic Endothelial Cells;Malignant Neoplasms;Measures;Mediating;Modeling;multiplexed imaging;Mus;neoplastic cell;neovasculature;novel therapeutic intervention;Oncogenic;Physiological;Preclinical Testing;Procedures;Proliferating;Protocols documentation;Public Health;Role;Solid Neoplasm;Stains;Standardization;Study models;subcutaneous;Subcutaneous Injections;Testing;Therapeutic;therapeutic evaluation;Therapeutic Intervention;Time;tumor;tumor xenograft;tumorigenesis;tumorigenic;Viral;Viral Markers;Work;Xenograft Model;Xenograft procedure

PROJECT_TITLE: Developing KSHV-Infected Lymphatic Endothelial Cell-Based Models of Kaposi’s Sarcoma

STUDY_SECTION: HCAC

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


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Autoimmune Disease;Biotechnology;Celiac Disease;Digestive Diseases;Immunotherapy;Nutrition;Prevention

ORG_CITY: St Louis

ORG_NAME: ANTIGER THERAPEUTICS INC.

ORG_STATE: MO

PHR: PROJECT NARRATIVE/PUBLIC HEALTH RELEVANCE STATEMENT Celiac disease (CD) is a chronic autoimmune disease affecting 100 million people worldwide, with serious health risks such as malnutrition, anemia, reduced bone density, neurological disorders, and cancers like lymphoma. There is currently no cure for CD or specific treatment addressing the immunogenetic root cause of CD, which motivated this project to develop a novel immunotherapy to target pathogenic immune cells driving the onset and progression of CD. The ultimate product of this project should significantly advance our mission to improve the well-being of those afflicted by this severe and prevalent disease without compromising the protective immunity for infection and cancer control.

PI_NAMEs: GUO, HONGJIE  (contact)

PROGRAM_OFFICER_NAME: MINNICOZZI, MICHAEL

PROJECT_TERMS: Accidents;Address;Adherence;Affect;Anemia;Antibodies;Antigens;Autoantigens;Autoimmune Diseases;Automobile Driving;Biochemical;Biological;Biological Products;Biotechnology;Bone Density;Cancer Control;Celiac Disease;Cell Culture System;Cells;Chimeric Proteins;Chronic;chronic autoimmune disease;Collaborations;commercial application;Complex;Consumption;deamidation;Detergents;Development;dietary;dimer;Dimerization;Disease;Disease Management;disease model;disorder control;disorder prevention;disulfide bond;Disulfides;Economic Burden;Engineering;experience;Extracellular Domain;Fc Immunoglobulins;FDA approved;gastrointestinal symptom;global health;Gluten;Gluten-free diet;Goals;Graft Rejection;Grant;Health;HLA Antigens;Human;Hybridomas;IgG1;Immune;Immune response;Immune Tolerance;Immunity;Immunogenetics;immunogenicity;Immunosuppression;Immunotherapy;improved;In Vitro;Individual;Infection Control;Ingestion;innovation;Insulin-Dependent Diabetes Mellitus;Integral Membrane Protein;interest;Intestines;Investigational Drugs;Length;Licensing;Link;Lymphoma;Malignant Neoplasms;Malnutrition;Mammalian Cell;Marketing;Measures;Mediating;Membrane Proteins;Micelles;Mission;Modification;Mus;Mutate;Nervous System Disorder;novel;Outcome;Pathogenesis;Pathogenicity;Patients;Peptides;Personal Satisfaction;Persons;Pharmaceutical Preparations;Pharmacologic Substance;Phase;phase 2 study;Population;Populations at Risk;Preparation;preservation;Prevalence;prevent;Prevention;Production;Proteins;prototype;public health relevance;Recombinants;Recurrence;Refractory;Rheumatoid Arthritis;Risk;Site;Site-Directed Mutagenesis;Small Business Innovation Research Grant;Small Intestines;social implication;socioeconomics;Structure;success;Symptoms;T-Lymphocyte;technological innovation;Technology;Testing;Therapeutic;therapeutic target;Toxic effect;Transmembrane Domain;Work

PROJECT_TITLE: Peptide-HLA-DQ2 biologics for antigen-specific therapy in Celiac Disease

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


NIH_SPENDING_CATS: Bioengineering;Biotechnology;HIV/AIDS;Immunization;Infectious Diseases;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Prevention;Vaccine Related;Vaccine Related - AIDS

ORG_CITY: SEATTLE

ORG_DEPT: PATHOLOGY

ORG_NAME: UNIVERSITY OF WASHINGTON

ORG_STATE: WA

PHR: PROJECT NARRATIVE Here we will use an innovative combination of sequence-based bioinformatic tools, artificial intelligence and machine learning based in silico structural prediction approaches, and in vitro biochemical and immunologic studies to select HIV-1 envelope vaccine immunogens that maximize exposure of epitopes recognized by broadly neutralizing antibodies, including the CD4 binding site.

PI_NAMEs: DERDEYN, CYNTHIA ANN (contact);GNANAKARAN, SANDRASEGARAM

PROGRAM_OFFICER_NAME: WARREN, JON T

PROJECT_TERMS: Adjuvant;Affinity;Antibodies;Antibody Binding Sites;Antigens;Apical;Artificial Intelligence;Autologous;B-Lymphocytes;Base Sequence;Binding;Binding Sites;Biochemical;Bioinformatics;bioinformatics tool;breakthrough infection;Cell Lineage;Cell Separation;Characteristics;Chronic;Clinical;Clinical Research;Clonal Expansion;Complement;computational pipelines;Cryopreservation;Data;design;Development;Epitope Mapping;Epitopes;Evolution;Exposure to;Genomics;Germ Lines;Glycoproteins;glycosylation;HIV;HIV envelope protein;HIV Envelope Protein gp120;HIV-1;Homing;Immunization;Immunize;Immunologics;Immunology;in silico;In Vitro;Infection;innovation;insight;interest;Interferometry;Light;lymph nodes;Macaca mulatta;Machine Learning;Maps;Mediating;Methods;Modeling;Monoclonal Antibodies;multi-scale modeling;neutralizing antibody;nonhuman primate;novel;pathogenic virus;Pathway interactions;Persons;Phenotype;Plasma;Polysaccharides;Population;predictive tools;pressure;Process;Protein Conformation;receptor;Rectum;Resistance;response;Role;sample collection;Sequence Analysis;Series;Serum;simian human immunodeficiency virus;simulation;Site;Specificity;synergism;Testing;three dimensional structure;Time;transmission process;Vaccination;vaccination strategy;Vaccine Design;Vaccines;Variant;Viral;virus characteristic

PROJECT_TITLE: Exploiting glycan holes and sequence diversity of naturally occurring HIV envelope towards the design of vaccine immunogen panels for induction of neutralization breadth

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


ADMINISTERING_IC: MH

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Behavioral and Social Science;Brain Disorders;Child Abuse and Neglect Research;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Depression;Dissemination and Implementation Research;Mental Health;Pediatric;Prevention;Social Determinants of Health;Violence Research;Youth Violence

ORG_CITY: EUGENE

ORG_NAME: NORTHWEST PREVENTION SCIENCE INC

ORG_STATE: OR

PHR: Project Narrative This research will focus on examining the effectiveness of the Family Check-Up Online for improving mental and behavioral health in children and families when embedded in school delivery systems. School providers will be trained in the digital health intervention and will provide the treatment to underserved families in multiple districts. This research will significantly advance our understanding of effective behavioral health interventions that can be widely delivered in schools and has the potential to substantially improve public health in the United States.

PI_NAMEs: MAURICIO, ANNE MARIE;REITER, LISA ANN (contact);STORMSHAK, ELIZABETH A

PROGRAM_OFFICER_NAME: SWEENEY, MARY MARGARET

PROJECT_TERMS: academic preparation;acceptability and feasibility;Adolescent;Adoption;Adult;Award;Behavior;Behavior Disorders;Behavior Therapy;Behavioral;behavioral health;behavioral health intervention;Characteristics;checkup examination;Child;Child Behavior;Child Mental Health;Child Rearing;Clinical;Clinical Trials;commercialization;Communities;comparative effectiveness trial;conduct problem;COVID-19 impact;COVID-19 pandemic;Data;Data Collection;digital;digital health;digital technology;Early Intervention;effectiveness evaluation;effectiveness trial;effectiveness/implementation trial;efficacious treatment;Enrollment;evidence base;Evidence based practice;Evidence based program;experience;Family;Family Relationship;family support;Family Violence;Feedback;Funding;Future;Health Benefit;Health Technology;high risk;Home;Human Resources;Hybrids;implementation determinants;implementation framework;implementation strategy;improved;improved outcome;Intervention;Interview;junior high school;Maintenance;Marketing;Mental Depression;Mental Health;Mental Health Services;Methods;Modeling;Monitor;novel;Outcome;Parents;Personal Satisfaction;Persons;Phase;Population;preference;prevent;preventive intervention;Primary Schools;Problem behavior;Process;programs;Provider;Public Health;Randomized;Reach, Effectiveness, Adoption, Implementation, and Maintenance;Reporting;Research;Research Personnel;Resources;Risk;routine care;school environment;Schools;Series;Services;skills;Small Business Innovation Research Grant;Source;Students;Support System;System;Testing;therapy design;tool;Training;Trust;Underserved Population;United States;uptake;web app;Work;Youth

PROJECT_TITLE: A Digital Health Technology to Prevent Family Violence and Improve Child Mental Health

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


ADMINISTERING_IC: DC

IC_NAME: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

ORG_CITY: LADERA RANCH

ORG_NAME: FEMTOVOX INCORPORATED

PHR: With an economy increasingly prioritizing communication, chronic communication disorders related to the voice box, arising from both malignant and benign pathologies, are growing at a rate of 8-13% per year. FemtoVox’s technology, which includes automated surgery using a laser that causes 20-40x less damage and is guided by sophisticated imaging, can lower complications and shorten recovery times by 2-4 times, while also eliminating the risk of lethal airway fires. This technology offers a superior solution for the 120,000 annual larynx surgeries and provides a path forward for the 400,000 Americans diagnosed each year with benign pathologies, which are currently not operated on due to technology limitations.

PI_NAMEs: SHARMA, MANU  (contact)

PROGRAM_OFFICER_NAME: KOPF, LISA MARIE

PROJECT_TERMS: Ablation;Academic Medical Centers;Accreditation;American;Animals;Automation;Benign;Blood Vessels;Cadaver;career networking;Chick;chorioallantoic membrane;Chronic;Clinical;clinical application;clinically relevant;Coagulation Process;commercialization;Communication;Communication impairment;Complication;Data;design;Devices;Diagnosis;Dropout;Engineering;Epithelium;Equilibrium;Excision;experience;Failure;Fire - disasters;Goals;Head and Neck Surgeon;Health;Health Care Costs;Hemostatic function;Histology;Histopathology;Hospitals;Image;image guided;improved;in vivo;in vivo Model;Industry;Inflammation;instrument;Interview;Language Therapy;Larynx;Laser Surgery;Lasers;Lesion;Malignant - descriptor;Market Research;Medical Technology;member;membrane model;Mission;Modification;neurosurgery;Nodule;operation;Operative Surgical Procedures;Optical Coherence Tomography;Optics;Oral cavity;Outcome;Pathology;Patient Care;Patient-Focused Outcomes;Patients;Personal Satisfaction;Pharyngeal structure;Phase;Physiologic pulse;Polyps;Postoperative Period;pre-clinical;preservation;Privatization;Process;prototype;Quality of life;Recommendation;Records;Recovery;Repeat Surgery;research study;Retreatment;Risk;scalpel;Scanning;soft tissue;Solid;Speech;Speech Therapy;Speed;Spottings;Steel;Surgeon;surgery outcome;System;Techniques;Technology;technology platform;Thinness;Time;Tissue Preservation;Tissue Sample;Tissues;United States National Institutes of Health;Vascularization;Vendor;Veterinarians;Voice;Work;wound healing

PROJECT_TITLE: Image-guided automated ultrafast laser device for laryngeal surgery to expand treatment options and improve patient outcomes

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


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Biotechnology;Breast Cancer;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Women's Health Research

ORG_CITY: BOSTON

ORG_NAME: TRANSCODE THERAPEUTICS, INC.

PHR: NARRATIVE Metastatic disease is responsible for ~90% of cancer deaths and is the primary determinant in the life-limiting aspect of cancer. TransCode Therapeutics has developed a pharmacological inhibitor of miRNA-10b, called TTX-MC138, that has successfully regressed established metastatic disease in preclinical models of cancer and is currently performing a Phase 0 clinical trial. We propose to accelerate the development of the miR-10b inhibitor and move it towards commercialization by performing key translational experiments, including IND- enabling and IND-supported Phase Ia studies in advanced cancer patients.

PI_NAMEs: MEDAROVA, ZDRAVKA O (contact)

PROGRAM_OFFICER_NAME: DJEMIL, SARRA

PROJECT_TERMS: Acceleration;Address;Advanced Malignant Neoplasm;Agreement;Animals;Antisense Oligonucleotides;Authorization documentation;Biological Markers;bone;Brain;Breast Cancer Model;Cancer Model;Cancer Patient;cancer type;Canis familiaris;Cells;Cessation of life;chemotherapy;Clinical;Clinical Data;clinical development;Clinical Research;Clinical Trials;cohort;commercialization;Communication;companion animal;Development;Dextrans;Disease;Disease-Free Survival;Disseminated Malignant Neoplasm;Distant Metastasis;Dose;Drug Delivery Systems;drug development;Drug Kinetics;efficacy study;efficacy trial;Evaluation;experimental study;exposed human population;Funding;Generations;In complete remission;in vivo;inhibitor;Injections;Institutional Review Boards;intravenous injection;Investigational Drugs;Investigational New Drug Application;iron oxide nanoparticle;Label;Legal patent;Life;life span;Lung;lymph nodes;Magnetic Resonance Imaging;Malignant - descriptor;Malignant Neoplasms;Mediating;Metastatic breast cancer;MicroRNAs;Modality;mouse model;Neoplasm Metastasis;neoplastic cell;nonhuman primate;novel therapeutics;Operative Surgical Procedures;Outcome;pancreatic cancer model;Patients;pharmacokinetics and pharmacodynamics;pharmacologic;Phase;Phase 0 Clinical Trial;Phase 0 Study;Phase 0 Trial;Phase I Clinical Trials;Positron-Emission Tomography;pre-clinical;Pre-Clinical Model;preclinical efficacy;preclinical study;Predisposition;primary endpoint;Primary Neoplasm;programs;Protocols documentation;Radiation therapy;Radiolabeled;Rattus;Recurrence;Recurrent disease;research clinical testing;response;Risk;Safety;safety study;Signal Transduction;Small Business Innovation Research Grant;Solid;Solid Neoplasm;success;systemic toxicity;Technology;Therapeutic;Therapeutic Agents;therapeutic development;Therapeutic Intervention;Time;Toxic effect;Toxicokinetics;Toxicology;trial design;tumor;Untranslated RNA;Visualization;War;Work

PROJECT_TITLE: Phase I Clinical Testing of a First-in-Class Therapy against Metastatic Cancer

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


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

ORG_CITY: LOS ANGELES

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: UNIVERSITY OF CALIFORNIA LOS ANGELES

PHR: PROJECT NARRATIVE/RELEVANCE TO PUBLIC HEALTH With chimeric antigen receptor gene therapy for cancer being a growing area of therapeutic promise, there is great unmet potential for application to HIV treatment. This project addresses a cellular immune defect specific to HIV that could enhance the utility of CARs for the functional cure of HIV infection.

PI_NAMEs: YANG, OTTO O (contact)

PROGRAM_OFFICER_NAME: POON, BETTY

PROJECT_TERMS: Abnormal Cell;Acute;adaptive immunity;Address;Antigens;Area;arm;Binding;BLT mice;cancer therapy;CAR T cell therapy;CD8-Positive T-Lymphocytes;Cell surface;Cells;chimeric antigen receptor;chimeric antigen receptor T cells;Chronic;chronic infection;Chronic Phase;Clinical Trials;Clonal Expansion;Coupling;Cytomegalovirus;Cytomegalovirus Infections;Cytoplasmic Protein;cytotoxic CD8 T cells;Cytotoxic T-Lymphocytes;Data;Defect;Dependence;Development;Effector Cell;effector T cell;Evolution;exhaustion;Exhibits;Frequencies;gene therapy;Generations;Genome Scan;Goals;Histocompatibility Antigens Class I;HIV;HIV Infections;HIV-1;Immune;immune activation;Immunity;In Vitro;in vivo;Infection;Infection Control;Macaca;Maintenance;Major Histocompatibility Complex;Malignant Neoplasms;Mediating;Memory;Morbidity - disease rate;mortality;mouse model;multicatalytic endopeptidase complex;Mutation;partial response;Pathogenesis;Pathogenicity;Pathway interactions;Peptides;Persons;Plasma;Play;Proteins;prototype;Public Health;response;Rest;Risk;RNA;Role;Sampling;Scanning;SIV;Source;T cell response;T-Cell Receptor;T-Lymphocyte;Therapeutic;Transportation;Viral;Viral Physiology;Viremia;Virus;Virus Replication

PROJECT_TITLE: Harnessing the Pathogenesis of CMV Against HIV

STUDY_SECTION: HIVD

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


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Biotechnology;Brain Disorders;Cancer;Drug Abuse (NIDA only);Electronic Nicotine Delivery Systems;Lung;Lung Cancer;Mental Health;Pediatric;Prevention;Substance Misuse;Tobacco;Tobacco Smoke and Health

ORG_CITY: PHILADELPHIA

ORG_NAME: FLIK THERAPEUTICS, INC.

ORG_STATE: PA

PHR: PROJECT NARRATIVE Over 80% of the 30 million+ smokers in the United States report a desire to quit, yet there is a severe lack of effective, FDA-approved smoking cessation therapies to support their efforts. In response to recent calls to action from Key Opinion Leaders and the Biden Administration, including a draft framework from the U.S. Department of Health and Human Services to “promote ongoing and innovative research to support and accelerate smoking cessation,” our goal is to develop a highly structured, multimodal nicotine cessation program with dramatically higher efficacy than the current standard of care. This Phase I proposal is intended to support the development of the novel FDA-regulated pharmacotherapy at the core of our platform.

PI_NAMEs: HEIDEN, BRENDAN  (contact)

PROGRAM_OFFICER_NAME: NGUYEN, TAM L

PROJECT_TERMS: Acceleration;Acquired Immunodeficiency Syndrome;addiction;Address;Adult;aerosolized;Aerosols;Alcohols;Alveolar;American;appropriate dose;aqueous;automobile accident;Behavioral;biopharmaceutical industry;Bupropion;Centers for Disease Control and Prevention (U.S.);Cessation of life;Chantix;Characteristics;Cigarette;cigarette smoke;cigarette smoking;Clinical;Collaborations;combustible cigarette;companion diagnostics;Complex;Computer Models;Computer software;Data;Deposition;Development;Devices;Disease;Drug Delivery Systems;drug inhalation;Drug Kinetics;effective therapy;Electronic cigarette;electronic cigarette use;Ensure;Excipients;FDA approved;first-in-human;Formulation;Generations;Goals;Health;Health Care Costs;Health Personnel;Health Policy;Healthcare;high school;High School Student;in vitro testing;Individual;Industry;Inhalation;Inhalators;innovation;Lung;Malignant Neoplasms;Measures;Medical;Modeling;Modernization;multimodality;Murder;Nebulizer;neuropsychiatry;Nicotine;nicotine cessation;Nicotine Dependence;nicotine inhalation;nicotine replacement;Nose;novel;novel therapeutics;Oral;Particle Size;Patients;Perception;Performance;Persons;Pharmaceutical Preparations;Pharmacotherapy;Phase;preclinical development;preventable death;product development;programs;Public Health;Publishing;Recreation;Reporting;Research;response;side effect;Smoker;Smoking;smoking addiction;smoking cessation;Sodium Chloride;stability testing;standard care;standard of care;statistics;Structure;success;Suicide;System;Technology;Testing;Therapeutic;Time;Tobacco;Toxicology;United States;United States Dept. of Health and Human Services;vaper;vaping;varenicline;vibration;Weaning;Work;young adult;Youth;Zyban

PROJECT_TITLE: Development of a novel therapeutic platform for smoking cessation and nicotine de-addiction


ORG_CITY: Boxborough

ORG_NAME: HELIXBIND, INC.

PHR: PROJECT NARRATIVE Sepsis, the body’s response to a bloodstream infection, is one of the leading causes of death and most expensive conditions to treat in US hospitals. Timely administration of appropriate antimicrobials is critical for improving patient outcomes. However, current diagnostics for identifying the infection, necessary for selection of the appropriate antimicrobials, require days to provide results and may fail to detect mixed infections or infection in patients on antimicrobials. This Direct-to-Phase II proposal is aimed at verifying and validating an automated, culture-free assay to identify bloodstream infections direct from blood in only a few hours. Successful completion of the proposed work will provide data necessary for a filing for FDA clearance of this novel device.

PI_NAMEs: SINGER, ALON  (contact)

PROGRAM_OFFICER_NAME: RITCHIE, ALEC

PROJECT_TERMS: Address;Adopted;Agreement;Antibiotic Resistance;antimicrobial;Antimicrobial Resistance;Biological Assay;Blood;Breakthrough device;Budgets;Caring;Cause of Death;Cessation of life;Clinical;Clinical Microbiology;Clinical Research;clinical research site;Collaborations;commercialization;Communicable Diseases;cost;Data;design;Detection;Deterioration;Development;Devices;Diagnostic;diagnostic strategy;Early Diagnosis;Enrollment;Ensure;experience;Hospitalization;Hospitals;Hour;improved;Infection;innovation;institutional financing;instrument;Intervention;Laboratories;Lead;Leadership;manufacture;Marketing;member;Methods;microbial;Molecular;mortality;novel;pathogen;pathogenic bacteria;pathogenic fungus;patient prognosis;Patient-Focused Outcomes;Patients;Phase;Preparation;Process;product development;Quality of life;Research Design;Resistance;Resistance development;response;Sampling;Sepsis;Septicemia;service utilization;standard of care;success;System;systemic inflammatory response;Technology;Temperature;Testing;Time;timeline;validation studies;verification and validation;Whole Blood;Work

PROJECT_TITLE: An automated culture-free system for the identification of bloodstream infections direct from blood

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


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease Related Dementias (ADRD);Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Amyotrophic Lateral Sclerosis (ALS);Brain Disorders;Dementia;Neurodegenerative;Neurosciences;Orphan Drug;Precision Medicine;Rare Diseases

ORG_CITY: ARLINGTON

ORG_NAME: NEURODEX INC

PHR: PROJECT NARRATIVE  Drug development for amyotrophic lateral sclerosis (ALS) is complicated by differences in patient rate of progression, the inclusion of misdiagnosed patients in clinical trials, and a lack of objective measures to track the pathology of the disease over time and in response to treatment. This project is designed to advance the development of a new biomarker to aid in predicting patient rate of progression, improving diagnosis, and tracking treatment response. Commercialization of this new biomarker is expected to improve the efficiency and success of clinical trials, leading to the availability of new and better drugs to treat patients with ALS.

PI_NAMEs: EITAN, EREZ  (contact)

PROJECT_TERMS: Address;Adopted;Advanced Development;Affect;ALS pathology;ALS patients;Alzheimer's Disease;Alzheimer's disease related dementia;Amyloid beta-Protein;Amyotrophic Lateral Sclerosis;amyotrophic lateral sclerosis therapy;analytical method;Biological Assay;Biological Markers;biomarker discovery;biomarker performance;Blood;blood-based biomarker;Brain;Cathepsins;Clinical;clinical care;Clinical Trials;Cohort Analysis;commercialization;Congresses;design;Development;Diagnosis;Diagnostic;diagnostic assay;diagnostic biomarker;Disease;disease model;Disease Progression;drug development;drug testing;end of life;Etiology;Evaluation;Exclusion;experience;extracellular vesicles;FDA approved;Frontotemporal Dementia;functional decline;Future;Genotype;Goals;Guidelines;Heterogeneity;improved;individual patient;innovative technologies;interest;Investments;Life Expectancy;Light;Longitudinal cohort;Market Research;Measures;Medical Research;Messenger RNA;Methods;mouse model;Nerve Degeneration;Neurodegenerative Disorders;neurofilament;neuron development;Neurons;novel therapeutics;Pathologic;Pathology;Patient Care;patient stratification;Patients;Performance;Persons;Pharmaceutical Preparations;Phase;Phenotype;phenylmethylpyrazolone;Plasma;Probability;Prognosis;programs;protein TDP-43;Proteins;Quality of life;response;response biomarker;Riluzole;Sample Size;Small Business Innovation Research Grant;Source;specific biomarkers;Specificity;Stratification;Subgroup;success;symptom management;tau Proteins;Testing;therapeutic candidate;Time;timeline;Tissues;tool;treatment response;Validation;validation studies;Work

PROJECT_TITLE: Blood-based Biomarker for Characterizing Progression and Therapeutic Response in Amyotrophic Lateral Sclerosis


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

ORG_CITY: Seattle

ORG_NAME: VIRTICI, LLC

PHR: Project Narrative Frontotemporal Lobar Degeneration (FTD) is a form of dementia that afflicts an estimated 60,000 patients in the US1. Inadequate methods for early-stage diagnosis have contributed to the poor characterization of patient subgroups, hindering the advancement and interpretation of therapeutic clinical trials, and leaving caregivers without a clear understanding of the likely progression of the disease. The goal of this project is to develop a blood test for early diagnosis of FTD.

PI_NAMEs: FANGER, NEIL A (contact)

PROJECT_TERMS: accurate diagnosis;Age;alpha synuclein;Alzheimer's Disease;Alzheimer's disease patient;Alzheimer's disease related dementia;Amyloid beta-Protein;Anterior;Antibodies;antibody detection;assay development;Autopsy;Behavior;Binding;Biological Assay;Biological Markers;Blinded;Blood;Blood specimen;Blood Tests;Brain;Brain imaging;Caregivers;Caring;Classification;Clinical Trials;Cognitive;Collection;Complex;Consensus;cost;Data;Data Set;Dementia;design;Detection;detection sensitivity;Development;Diagnosis;Diagnostic;Diagnostic tests;Disease;Disease Progression;drug development;Early Diagnosis;Electrophysiology (science);Frontotemporal Lobar Degenerations;FYN gene;Goals;Health;Immunoassay;innovation;Language;Lead;Lobe;Measures;Medical;Methods;Modeling;Neurodegenerative Disorders;Neurologic;Neurons;novel;Pathologic;patient stratification;patient subsets;Patients;Performance;performance tests;Phase;Plasma;Plasma Proteins;Positioning Attribute;Presenile Dementia;protein aggregation;protein oligomer;protein TDP-43;Proteins;Reaction;repository;Research Institute;Risk Behaviors;Sampling;Sensitivity and Specificity;skills;Small Business Innovation Research Grant;Source;Spinal Puncture;Standardization;Stratification;Subgroup;Symptoms;tau Proteins;Techniques;Testing;Therapeutic Clinical Trial;Time;tool;Training;Treatment outcome;validation studies;Variant;Work

PROJECT_TITLE: A Novel Blood Test for Early Diagnosis of Frontotemporal Lobar Degeneration


ADMINISTERING_IC: GM

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Biotechnology;Genetics

ORG_CITY: SHORELINE

ORG_NAME: DOTQUANT, LLC

PHR: NARRATIVE We propose to develop an innovative RNA synthesis kit capable of incorporating chemically modified nucleotides for increasing RNA circulation stability with an at least 10-fold higher yield than current kits. The high yield will significantly reduce the cost of RNA research and RNA drug development.

PI_NAMEs: LIU, HONG YAN  (contact)

PROGRAM_OFFICER_NAME: CHO, THOMAS Y

PROJECT_TERMS: Address;Affect;Antibodies;aptamer;Automobile Driving;Bacteriophage T7;Biological Process;Biomedical Research;Biotechnology;Buffers;Catalytic RNA;Cations;chemical synthesis;Chemicals;Circulation;Clinical;clinically significant;Communities;Complex;cost;CRISPR/Cas technology;Development;Digestion;DNA;DNA-Directed RNA Polymerase;drug development;Drug Industry;Engineering;Enzymes;Evaluation;FDA approved;fluoropyrimidine;Formulation;Future;gene editing technology;Genes;Genetic Transcription;genome editing;Goals;Healthcare;improved;In Vitro;innovation;innovative technologies;Institution;Insurance;interest;Ligands;Marketing;Medicine;Methods;Modification;Molecular Conformation;mutant;Mutate;Mutation;nuclease;Nucleotides;Patients;Pharmaceutical Preparations;Phase;Play;Polymerase;prevent;Production;protein expression;protein misfolding;Proteins;Protocols documentation;Research;Resistance;Ribose;RNA;RNA chemical synthesis;RNA Instability;RNA Interference;RNA Sequences;RNA Splicing;RNA Stability;Role;S phase;Series;Serum;Solid;Substrate Specificity;System;T7 RNA polymerase;Technology;Testing;therapeutic RNA;three dimensional structure;Transcript;Translations;Untranslated RNA;Vaccines

PROJECT_TITLE: Development of a WT RNAP-based kit for high-yield synthesis of chemically modified RNA

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


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Assistive Technology;Bioengineering;Cardiovascular;Emergency Care;Lung;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Preterm, Low Birth Weight and Health of the Newborn

ORG_CITY: MAPLE GROVE

ORG_NAME: ADVANCED MEDICAL ELECTRONICS CORPORATION

ORG_STATE: MN

PHR: Project Narrative This project involves creating a new device to assist providers in treatment of pneumothorax, which is a life- threatening condition in which air escapes the lungs causing the chest wall to expand and compress the lungs. Pneumothorax can occur in adults or children, but it is generally more severe in newborns as the lungs are not fully developed. The project will build and evaluate a new tool for the treatment of pneumothorax.

PI_NAMEs: STRUTT, JONATHAN R (contact)

PROGRAM_OFFICER_NAME: SOOD, BEENA G

PROJECT_TERMS: Acute;Adult;Air;Air Movements;aspirate;Breathing;Butterflies;Cannulas;Cardiovascular system;Cessation of life;Chest;Chest Tubes;Chest wall structure;Child;Childhood;clinical practice;Collaborations;commercialization;Consumption;Continuous Positive Airway Pressure;Critical Care;Dedications;design;Development;Device Designs;Device or Instrument Development;Devices;Diagnosis;Drainage procedure;efficacy trial;Emergency Medicine;Emergency Situation;Engineering;Evaluation;experience;Faculty;Feasibility Studies;Feedback;Heart Rate;Hypotension;Hypoxia;improved;Injury;innovation;interest;Intuition;Lead;Left;Life;Lung;lung injury;Manikins;manufacture;Marketing;Medical;Medical Device;Medical Device Designs;Medical Electronics;Methods;mid-career faculty;Minnesota;Modeling;Movement;Needles;Neonatal;Neonatal Intensive Care Units;Newborn Infant;Nose;novel;Organ;Oxygen;Patients;pediatric department;pediatric emergency;Pediatrics;Penetration;Phase;Physicians;Physiology;Pleural;Pleural cavity;Pneumothorax;premature;Premature Infant;prevent;Procedures;Production;professor;prototype;Provider;Pump;Recording of previous events;Research;Research Personnel;respiratory;respiratory distress syndrome;Risk;Risk Reduction;Safety;skills;Specialist;Specific qualifier value;standard of care;Structure;Structure of parenchyma of lung;surfactant;Symptoms;Syringes;System;Tachycardia;Technology;Therapeutic;Time;Tissues;tool;Training;ultrasound;Universities;ventilation

PROJECT_TITLE: Innovative Pneumothorax Decompression Device

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


NIH_SPENDING_CATS: Aging;Biotechnology;Chronic Obstructive Pulmonary Disease;Genetics;HIV/AIDS;Infectious Diseases;Lung;Prevention;Tobacco;Tobacco Smoke and Health

ORG_CITY: MIAMI

ORG_NAME: FLORIDA INTERNATIONAL UNIVERSITY

PHR: PROJECT NARRATIVE: Lung diseases such as COPD and recurrent lung infections are emerging as significant comorbidity in people living with HIV (PLWH) and its pathophysiological mechanism influenced by HIV Tat and effects of cigarette smoke regimen remains unclear. HIV Tat and TGF-β1 promotes an aberrant microRNAome in the primary bronchial epithelium and upregulates miR-126-3p, a microRNA known to suppress IRS-1 leading to PI3K/Akt hyperactivation and consequently NF-kβ-activated ADAM17 upregulation with consequent cellular senescence and inflammation. The project determines if IRS-1 specific microRNA antagonism to restore baseline IRS-1 with ADAM17 levels can mitigate its downstream effects on mitophagy, senescence and inflammation in the context of HIV and cigarette smoke.

PI_NAMEs: CHINNAPAIYAN, SRINIVASAN  (contact)

PROGRAM_OFFICER_NAME: MONGODIN, EMMANUEL FRANCK

PROJECT_TERMS: 3' Untranslated Regions;Abbreviations;Accounting;Aging;Air;Airway Disease;airway epithelium;airway surface liquid;antagonist;antiretroviral therapy;Asthma;autocrine;Bacterial Pneumonia;bronchial epithelium;Bronchoalveolar Lavage;Cell Aging;Cells;Chronic;Chronic lung disease;Chronic Obstructive Pulmonary Disease;chronic respiratory disease;cigarette smoke;cigarette smoke-induced;Clustered Regularly Interspaced Short Palindromic Repeats;comorbidity;Complex;Data;Development;Disintegrins;Emerging infection;Epithelial Cells;Event;Feedback;Functional disorder;Genes;Genetic Transcription;Goals;Guide RNA;HIV;HIV Infections;HIV Receptors;Homeostasis;Human;Impairment;improved;in silico;In Vitro;in vivo;Incidence;Inflammaging;Inflammation;insulin receptor substrate 1 protein;IRS1 gene;Life Expectancy;Liquid substance;Lung;Lung Diseases;lung health;Lung infections;Mediating;Metalloproteases;MicroRNAs;Mitochondria;Mitochondrial DNA;Molecular;Morbidity - disease rate;mortality;mouse model;Mus;novel;Oxidative Stress;paracrine;Pathologic;Pathway interactions;Patients;Pattern;Persons;PIK3CG gene;Play;Positioning Attribute;preservation;promoter;Proteins;pulmonary function decline;Pulmonary Inflammation;Pulmonary Surfactant-Associated Protein C;Recurrence;Regimen;Risk;Risk Factors;Role;senescence;senescence associated secretory phenotype;Severities;Signal Transduction;Site;Smoker;Smoking Status;Source;Stress;Testing;TGFB1 gene;therapeutic evaluation;TIMP3 gene;Tissues;Tobacco smoke;transcriptome;Transforming Growth Factor beta;Transgenic Mice;Transgenic Organisms;Untranslated Regions;Up-Regulation;Viral Load result

PROJECT_TITLE: A CRISP(e)R approach to alleviating HIV-associated COPD

STUDY_SECTION: HCCS

STUDY_SECTION_NAME: HIV Comorbidities and Clinical Studies Study Section[HCCS]


NIH_SPENDING_CATS: Biotechnology;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Digestive Diseases;Immunotherapy;Orphan Drug;Pancreatic Cancer;Rare Diseases

ORG_CITY: HOUSTON

ORG_NAME: MARKER THERAPEUTICS, INC.

ORG_STATE: TX

PHR: NARRATIVE This application will advance a novel T cell therapy, whereby white blood cells are trained in the laboratory to recognize and kill cancer cells. These killer cells have the capacity to recognize multiple surface markers expressed by the tumor cells but not healthy cells. Preliminary clinical data from the TACTOPS trial demonstrated a signal of efficacy including 1 Complete Response (CR) and 3 Partial Responses (PRs). To date, more than 200 patients have been treated in clinical studies with this type of therapy with no serious side effects. This project will advance cell therapy to treat patients with metastatic pancreatic adenocarcinoma in combination with existing frontline therapy, FOLFIRINOX.

PI_NAMEs: SMAGLO, BRANDON ;VERA, JUAN FERNANDO (contact)

PROGRAM_OFFICER_NAME: LOU, XING-JIAN

PROJECT_TERMS: advanced disease;antigen-specific T cells;Antigens;Autologous;Biologic Characteristic;Biological;Biological Products;Blood Component Removal;cancer cell;Cancer Control;cancer type;CD4 Positive T Lymphocytes;CD8-Positive T-Lymphocytes;CD8B1 gene;cell killing;Cell Therapy;Cells;Characteristics;chemotherapy;Clinical;Clinical Data;clinical efficacy;Clinical Protocols;Clinical Research;Clinical Trials;Combination Drug Therapy;Cryopreservation;Cyclic GMP;cytokine release syndrome;design;Desmoplastic;Diagnosis;Disease;Dose;effective therapy;efficacy outcomes;Eligibility Determination;Enrollment;Epitope spreading;Excision;Exclusion;follow-up;Future;gemcitabine;Grant;Growth;Hematologic Neoplasms;Immune;Immunologic Monitoring;Immunotherapy;improved;In complete remission;In Vitro;in vivo;Inflammatory;Infusion procedures;innovation;Intervention;Killer Cells;Laboratories;Leukapheresis;Leukocytes;Malignant neoplasm of pancreas;Malignant Neoplasms;manufacture;Medical;Metastatic Pancreatic Adenocarcinoma;neoplastic cell;neurotoxicity;novel;novel therapeutics;open label;Operative Surgical Procedures;Outcome;Paclitaxel;Pancreatic Adenocarcinoma;pancreatic cancer cells;pancreatic cancer patients;partial response;participant enrollment;Patient-Focused Outcomes;Patients;Performance;Phase;phase 1 study;Phenotype;Prognosis;Protocols documentation;Rare Diseases;Research Design;response;Safety;safety outcomes;safety testing;screening;side effect;Signal Transduction;Solid Neoplasm;Specificity;standard of care;success;Surface;T cell infiltration;T cell therapy;T-Cell Activation;T-Lymphocyte;targeted treatment;TCR Activation;therapeutic biomarker;Tissues;Toxic effect;Training;tumor;Tumor Antigens;Tumor Escape;tumor microenvironment;tumor-immune system interactions

PROJECT_TITLE: A Phase 1 Study of Patient-Derived Multi-Tumor Associated Antigen Specific T Cells (MT-601) Administered to Patients with Metastatic Pancreatic Cancer following frontline FOLFIRINOX

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


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Biotechnology;Emerging Infectious Diseases;Infectious Diseases;Lung;Orphan Drug;Rare Diseases;Tuberculosis

ORG_CITY: AUSTIN

ORG_NAME: VIA THERAPEUTICS, LLC

PHR: The proposed research is relevant to public health because we aim at developing and validating an inhaled phage product to treat tuberculosis, one of the most infectious and deadly diseases in human history. Therefore, the proposed research is relevant to the NIH’s mission of enhancing health, lengthening life, and reducing illness and disability.

PI_NAMEs: WARNKEN, ZACHARY N (contact)

PROGRAM_OFFICER_NAME: BOYCE, JIM P

PROJECT_TERMS: Acceleration;Accounting;Address;aerosolized;Aerosols;Air;Alveolar Macrophages;Animal Model;Antibiotic Resistance;Antibiotic Therapy;Antibiotics;Area;Bacteria;Bacterial Infections;Bacteriophages;biocompatible polymer;Buffers;Cessation of life;Characteristics;Chronic;Complex;Deposition;disability;Disease;Dose;Drug Delivery Systems;Drug Kinetics;Drug resistance;Dryness;efficacy testing;Encapsulated;Ensure;Exhibits;experience;extracellular;Film;Freeze Drying;Freezing;Frequencies;Future;future outbreak;Genus Mycobacterium;Goals;Granuloma;Health;health care availability;Human;Immune;improved;Inhalation;Inhalators;interfacial;Leucine;Life;liquid formulation;Liquid substance;Lung;Macrophage;Mannitol;microbiota;Mission;mouse model;Mucous Membrane;Mycobacteriophages;Mycobacterium tuberculosis;Nebulizer;non-tuberculous mycobacterial infection;Oral;Oral Administration;particle;pathogenic bacteria;Patient Noncompliance;Persons;Phase;phase 2 study;Polymers;Porosity;Povidone;Powder dose form;Process;Property;prototype;Public Health;Recording of previous events;Refrigeration;Regimen;Research;Research Personnel;Risk;Salts;shear stress;Specificity;Stress;Suspensions;targeted delivery;Technology;Therapeutic;Therapeutic Effect;Thinness;treatment duration;Treatment Protocols;Trehalose;Tuberculosis;tuberculosis treatment;United States National Institutes of Health;Virus

PROJECT_TITLE: Inhalable dry powders of mycobacteriophages for tuberculosis therapy

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


NIH_SPENDING_CATS: Aging;Atherosclerosis;Cardiovascular;Clinical Research;Clinical Trials and Supportive Activities;Diabetes;Digestive Diseases;Heart Disease;Nutrition;Obesity;Pain Research;Prevention

ORG_CITY: CHAPEL HILL

ORG_NAME: BIOKIER, INC.

ORG_STATE: NC

PHR: Narrative Cardiometabolic diseases are major health risks that are increasing in all parts of the world. Currently available treatments are limited because they do not work well, cause painful side effects, are difficult to take (require injections), and/or are invasive and expensive. In order to provide a safer and more effective alternative, BioKier has developed an orally deliverable, colon-targeted prescription product containing a natural active ingredient that is designed to improve cardiovascular disease-related conditions, including high cholesterol.

PI_NAMEs: SZEWCZYK, JERZY  (contact)

PROGRAM_OFFICER_NAME: HASAN, AHMED A  K

PROJECT_TERMS: absorption;Active Sites;Address;Affect;Alpha-glucosidase;Amines;analog;Apolipoproteins;Arthralgia;Biological Markers;Butyrates;Cardiometabolic Disease;cardiometabolism;Cardiovascular Diseases;cardiovascular disorder risk;cardiovascular risk factor;Catheters;Cause of Death;Cholesterol;Chronic;clinical development;Clinical Research;Colon;commercialization;Complement;controlled release;cost;Data;design;Desire for food;Development;Diabetes Mellitus;diabetic rat;Diarrhea;Disease;Disease remission;disorder risk;Dose;Dose Limiting;Drug Approval;Drug Kinetics;Drug Prescriptions;effective therapy;efficacy trial;Ensure;Enteroglucagon;Event;Fatty Liver;Fiber;Formulation;Funding;GLP-2;glucagon-like peptide 1;Glucose;Glucosidase Inhibitor;Goals;Health;Hormone secretion;Hormones;Hour;Human;hypercholesterolemia;Hyperglycemia;Hyperlipidemia;Impairment;improved;Incidence;Individual;Infusion procedures;Ingestion;inhibitor;Injectable;Injections;Insulin;Insulin Resistance;insulin sensitivity;Intervention;L Cells;LDL Cholesterol Lipoproteins;Lipids;lipoprotein cholesterol;Marketing;Metabolic;Metabolism;meter;Modeling;Morbid Obesity;Morbidity - disease rate;mortality;Myalgia;Myocardial Infarction;Non-Insulin-Dependent Diabetes Mellitus;novel;novel strategies;novel therapeutics;Nutrient;Obesity;Operative Surgical Procedures;Oral;Oral Administration;Oral cavity;Outcome Study;Oxides;Pain;Patients;Pharmaceutical Preparations;Phase;phase 1 study;Phase I Clinical Trials;Phase II Clinical Trials;Physiological;Pilot Projects;Plasma;Positioning Attribute;preclinical study;prevent;Production;Proprotein Convertases;Rattus;Recommendation;recruit;reduce symptoms;Regulation;Resistance;response;restoration;Risk;Role;Safety;safety assessment;side effect;Signaling Molecule;Small Business Innovation Research Grant;Source;Stomach;Stroke;Subjects Selections;Subtilisins;success;tablet formulation;Tablets;Target Populations;Testing;Therapeutic;Triglycerides

PROJECT_TITLE: Clinical development of a colon-targeted butyrate tablet to evaluate effects on cholesterol and trimethyl amine oxide in subjects at risk for cardiovascular disease


NIH_SPENDING_CATS: HIV/AIDS;Infectious Diseases

ORG_CITY: PORTLAND

ORG_DEPT: OTHER BASIC SCIENCES

ORG_NAME: OREGON HEALTH & SCIENCE UNIVERSITY

PHR: We propose to characterize how HIV-1 Gag and envelope proteins interact to facilitate the assembly of envelope proteins into virus particles, and to regulate the functions of envelope proteins in virus particles. These investigations will help clarify how HIV Gag and envelope proteins cooperate, and will foster the development of novel approaches to interfere with HIV-1 replication.

PI_NAMEs: BARKLIS, ERIC W (contact)

PROGRAM_OFFICER_NAME: MCDONALD, DAVID JOSEPH

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;AIDS diagnosis;Binding;Binding Sites;Biochemical;C-terminal;Cell membrane;cell type;Ceramides;Cholesterol;Collaborations;Cytoplasmic Tail;Defect;Detergents;Development;env Gene Products;Epidemic;Fostering;Foundations;Funding;gag Gene Products;Glycoproteins;Goals;HIV;HIV-1;Impairment;insight;Intracellular Membranes;Investigation;Ligands;Lipids;Membrane;Membrane Microdomains;Methods;Modeling;Molecular Chaperones;Molecular Conformation;Monitor;mutant;Mutation;myristoylation;N-terminal;nanobodies;novel;novel strategies;Phosphatidylinositol 4,5-Diphosphate;Phospholipids;Protein Precursors;Proteins;RNA;RNA Binding;Role;Signal Transduction;Site;Sphingomyelins;Structure;therapy design;trafficking;Variant;Viral;Virion;Virus;Virus Assembly

PROJECT_TITLE: HIV-1 Gag Precursor Protein Interactions

STUDY_SECTION: HVCD

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


NIH_SPENDING_CATS: Cancer;Colorectal Cancer;Digestive Diseases;Immunotherapy;Orphan Drug;Rare Diseases

ORG_CITY: GAITHERSBURG

ORG_NAME: SONOVAL LLC

ORG_STATE: MD

PHR: Narrative Solid tumors, including breast, lung, pancreatic, bladder, colon and ovarian cancers are a leading and rising cause of death worldwide. This project by the biotech company Sonoval will advance a novel anti-cancer agent that targets regulatory T cells (Tregs) for treatment of major solid tumors. By transiently and potently depleting CD25+ cells while being non-toxic to other cell types, Sonoval’s lead drug, SON-211, has the potential to address a critical need for effective new therapeutic options, and this study will characterize the drug’s action in tumors and initiate the pre-IND studies required for human studies.

PI_NAMEs: BISHAI, WILLIAM RAMSES;MURPHY, JOHN R.;SUZDAK, PETER DAVID (contact)

PROGRAM_OFFICER_NAME: BOZZA, WILLIAM PATRICK

PROJECT_TERMS: Address;Affinity;American;anti-PD-1;anti-tumor immune response;Antineoplastic Agents;antitumor effect;B-Lymphocytes;Biological Assay;Biopsy;Biotechnology;Blood Vessels;cancer immunotherapy;Cause of Death;CD8B1 gene;cell type;Cells;Chimeric Proteins;Clinical;Colon;Colon Carcinoma;Combined Modality Therapy;Corynebacterium diphtheriae;CT26;Cutaneous T-cell lymphoma;cytotoxic;Data;Denileukin Diftitox;Detergents;Diphtheria Toxin;Disease Progression;Dose;drug action;Equilibrium;Excision;experience;FOXP3 gene;Gene Dosage;Generations;Homeostasis;Human;IL2 gene;IL2RA gene;Immune;Immune checkpoint inhibitor;Immunotherapy;improved;In Vitro;in vivo;Infiltration;Inflammatory;Interferon Type II;Interleukin 2 Receptor;invention;Japan;Kidney;Lead;Lymphocyte;Malignant Breast Neoplasm;Malignant neoplasm of lung;Malignant neoplasm of ovary;Malignant neoplasm of pancreas;Malignant neoplasm of urinary bladder;Malignant Neoplasms;manufacture;Marketing;MC38;Melanoma;member;Membrane;Methods;Modeling;monomer;mouse model;Mus;Mutation;Non-Small-Cell Lung Carcinoma;novel;novel anticancer drug;novel therapeutics;Patients;Pharmaceutical Preparations;Phase;Play;Population;pre-IND studies;preservation;Production;programmed cell death protein 1;promoter;protein aggregation;Refractory;Regulatory T-Lymphocyte;Renal Cell Carcinoma;response;Role;Safety;Self Tolerance;single-cell RNA sequencing;Solid Neoplasm;Sorting;Sprague-Dawley Rats;Syndrome;synergism;T-Cell Depletion;T-Lymphocyte;T-Lymphocyte Subsets;targeted agent;Toxic effect;Toxicology;Toxin;Treatment outcome;Treatment Protocols;tumor;tumor growth;tumor microenvironment;tumor progression;Tumor Promotion;virtual

PROJECT_TITLE: Immunotherapy to deplete key Treg subsets in solid tumors

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


NIH_SPENDING_CATS: Adolescent Sexual Activity;Behavioral and Social Science;Bioengineering;Clinical Research;Contraception/Reproduction;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Infectious Diseases;Pediatric;Prevention;Racial and Ethnic Minority Health Research;Sexually Transmitted Infections;Teenage Pregnancy

ORG_CITY: WEST COVINA

ORG_NAME: SENTIENT RESEARCH, INC.

PHR: PROJECT NARRATIVE The Entertainment-Education and Technology for Adolescent Sexual Health (EETASH) intervention combines a brief, engaging, and culturally and age appropriate entertainment-education video and a comprehensive mobile health (mHealth) website with to prevent sexually transmitted infections (STIs), including HIV, and unintended pregnancy among Black/African American and Hispanic/Latino youth ages 16-20. EETASH will promote routine STI testing and the use of research-supported effective STI prevention methods, such as condoms and HIV pre- exposure prophylaxis (PrEP), as well as effective contraceptive methods (including dual contraception). We will employ human-centered design in this Phase I SBIR project to develop mHealth and entertainment-education prototypes with high levels of feasibility, acceptability, usability, and uptake among Black/African American and Hispanic/Latino youth and sexual and reproductive health service providers who ultimately will implement the intervention.

PI_NAMEs: MONTOYA, JORGE ALEJANDRO (contact)

PROGRAM_OFFICER_NAME: CHUANG, ELEANORE JENNIFER

PROJECT_TERMS: 19 year old;Address;Adolescent;Adolescent and Young Adult;adolescent sexual health;advocacy organizations;African American;Age;AIDS prevention;Area;Assessment tool;Awareness;Behavior;behavior change;Birth Rate;Black race;Centers for Disease Control and Prevention (U.S.);Chlamydia;Clinic;Collaborations;commercialization;community clinic;community organizations;condoms;Contraceptive Agents;Contraceptive methods;Couples;Dedications;design;Developed Countries;Diagnosis;Disparity;disparity reduction;Education;effective intervention;Elements;Ensure;ethnic minority;Evaluation Studies;Evidence based intervention;experience;Female;Focus Groups;Gonorrhea;Health;Health Personnel;Hispanic;HIV;HIV diagnosis;human centered design;Human immunodeficiency virus test;Individual;innovation;interest;Intervention;intervention refinement;Interview;Latina;Latino;Letters;Marketing;Mediation;Methods;mHealth;minority children;Modeling;Not Hispanic or Latino;Phase;Plants;pre-exposure prophylaxis;Pregnancy;Pregnancy in Adolescence;pregnancy prevention;Prevention;Prevention Research;Prevention strategy;preventive intervention;Process;programs;prototype;Provider;racial minority;Randomized;Randomized, Controlled Trials;Recording of previous events;Reporting;Reproductive Health Services;Research;Research Activity;Research Personnel;research study;Research Support;Resources;Risk Assessment;risk perception;school district;Schools;Self Efficacy;service providers;sexual and reproductive health;sexual health intervention;Sexually Transmitted Diseases;skills;Small Business Innovation Research Grant;Spanish/English;STI prevention;Surveys;Syphilis;Technology;Testing;tool;unintended pregnancy;Universities;uptake;usability;web site;White Women;Youth


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

ORG_CITY: CLIFTON PARK

ORG_NAME: KITWARE, INC.

ORG_STATE: NY

PHR: BANFF-AID: Banff Automated Nephrology Feature Framework - Artificial Intelligence Diagnosis Project Narrative (3 lines) Banff Lesion Scores are used by pathologists to assess kidney function before and after transplantation. We propose a web-based, Artificial Intelligence (AI)-powered software to automate Banff scoring. This will save time, decrease inter-observer variability, and improve the correlation of findings with clinical outcomes. 1

PI_NAMEs: CHAUDHARY, AASHISH  (contact)

PROGRAM_OFFICER_NAME: GOSSETT, DANIEL ROBERT

PROJECT_TERMS: Address;Adoption;Algorithms;allograft rejection;Allografting;Arteriosclerosis;Artificial Intelligence;artificial intelligence model;Artificial Intelligence platform;Atrophic;Automation;Biopsy;burnout;Classification;Clinical;Communities;community engagement;Computer Analysis;Computer software;computerized data processing;Consumption;Coupled;Custom;Data;data anonymization;Data Set;Decision Making;Development;Diagnosis;Diagnostic;Donor person;empowerment;Ensure;Evaluation;Event;experience;explainable artificial intelligence;Feedback;Fibrosis;Fostering;Foundations;Frozen Sections;Funding;Generations;glomerulosclerosis;Goals;Graft Survival;Grant;Health;Healthcare;Hematoxylin and Eosin Staining Method;Histopathology;Hospitals;Human;imaging Segmentation;improved;Individual;innovation;insight;intelligent diagnosis;interest;Interobserver Variability;interstitial;Intraobserver Variability;Kidney;kidney biopsy;Kidney Transplantation;Lesion;Manuals;Measurement;Measures;Medical;Metadata;Methodology;Methods;Mission;Modeling;Nature;Nephrology;Online Systems;open source;Organ;Organ Donor;Organ Transplantation;Outcome;outcome prediction;Paper;Pathologist;Patients;Phase;Play;Process;Process Assessment;process improvement;Renal function;Renal Tissue;Research;Retrospective Studies;Role;Shapes;Slide;Software Framework;Specimen;Stains;System;Time;tool;Transplantation;Trust;Tubular formation;United States National Institutes of Health;user-friendly;Visual;web based interface;web-accessible;whole slide imaging;Work;Workload


NIH_SPENDING_CATS: Bioengineering;Digestive Diseases;HIV/AIDS;Hepatitis;Hepatitis - C;Infectious Diseases;Liver Disease;Prevention;Substance Misuse

ORG_CITY: NEW HAVEN

ORG_DEPT: PUBLIC HEALTH & PREV MEDICINE

ORG_NAME: YALE UNIVERSITY

ORG_STATE: CT

PHR: Project Narrative No single intervention alone will be enough to stop the ongoing outbreaks of HIV and other infectious diseases among people who use drugs (PWUD) in the United States (US). In this application, we propose to develop better methods to predict outbreaks of infectious diseases among PWUD, to expeditiously detect these outbreaks when they emerge, and efficiently find cases of prevalent disease and get patients into treatment and care. The broad objective that guides this research is to provide a new set of tools to aid in ending the HIV epidemic among PWUD in the US.

PI_NAMEs: GONSALVES, GREGG STEVEN (contact);WARREN, JOSHUA LINDSEY

PROGRAM_OFFICER_NAME: DUNSTON, SHEBA KING

PROJECT_TERMS: Accounting;Address;Algorithms;Breathing;Caring;case finding;Collaborations;Communicable Diseases;Communities;Containment;Country;County;COVID-19 screening;Data;design;Detection;Development;Diagnosis;Disease;Disease Outbreaks;Drug usage;Drug user;Epidemic;Equity;Fingerprint;Flare;Goals;Health;Hepatitis C;Hepatitis C virus;high risk;HIV;HIV Infections;Hospitals;improved;improved outcome;Indiana;Infection;Infectious Skin Diseases;Infective endocarditis;innovation;Intervention;Life Cycle Stages;Locales;Mental Health;methamphetamine use;Methodology;Methods;Modeling;Municipalities;new outbreak;New York City;novel;opioid epidemic;outbreak concern;outbreak prediction;Overdose;overdose death;pathogen;Patients;Pattern;Pattern Recognition;Pharmaceutical Preparations;Pilot Projects;Population;Population Surveillance;Populations at Risk;prevent;Prevention;Public Health;Reporting;Research;Risk;Sampling;Sexually Transmitted Diseases;simulation;Soft Tissue Infections;Speed;Statistical Models;Strategic Planning;substance use;success;support tools;Syphilis;Technology;Test Result;Testing;Time;tool;transmission process;United States;United States National Institutes of Health;uptake;Work

PROJECT_TITLE: Predict, Detect, Diagnose: Confronting Outbreaks of HIV and Other Infectious Diseases Among People Who Use Drugs

STUDY_SECTION: PPAH

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


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

ORG_CITY: ANN ARBOR

ORG_NAME: GENETOBE INC.

ORG_STATE: MI

PHR: PROJECT NARRATIVE In the post-Trikafta era, Cystic fibrosis (CF) associated metabolic disorders are on the rise and have become the priority challenges in treating CF. In the present work, we propose to develop a first-in-class orally bioavailable Sodium/glucose cotransporter 1 (SGLT1) specific inhibitor as an adjunctive therapy for CF and to conduct preclinical testing in CF rabbits, based on the PI’s discovery that inhibiting SGLT1 may benefit CF associated metabolic disorders and the small business founders’ prior successes in drug discovery.

PI_NAMEs: REED, JESSICA ;XU, JIE  (contact)

PROGRAM_OFFICER_NAME: LI, YAN

PROJECT_TERMS: Address;Affect;Animal Disease Models;Animal Model;Artificial Intelligence;atorvastatin;Biological Assay;Biological Availability;Biological Models;Businesses;Clinical;Clinical Data;Cystic Fibrosis;cystic fibrosis patients;cystic fibrosis related diabetes;Cystic Fibrosis Transmembrane Conductance Regulator;Data;Dedications;design;Development;Diabetes Mellitus;Disease;Drug Design;drug discovery;Drug Interactions;Drug Kinetics;Evaluation;experimental study;Follow-Up Studies;Glucose;glucose metabolism;Half-Life;Heart failure;Hereditary Disease;Human;improved;in vivo evaluation;Individual;inhibitor;inhibitor therapy;Intestines;Kidney;Knowledge;Lead;lead optimization;Legal patent;Licensing;Literature;Liver;Liver diseases;liver function;Liver Microsomes;Lung;Marketing;Medical;Medicine;Metabolic;Metabolic Diseases;Michigan;Modeling;mortality;Mus;Mutation;novel;novel therapeutics;Obesity;Oral;Organ;Oryctolagus cuniculus;Outcome;overweight adults;Pancreas;Patients;Pharmaceutical Preparations;Phase;Phenotype;pre-clinical;Preclinical Testing;Prevalence;Process;pulmonary function;Rare Diseases;Regulator Genes;Reporting;Research;Research Priority;Sampling;Scientist;Small Business Technology Transfer Research;small molecule;Sodium;Specificity;Structure-Activity Relationship;success;symporter;Testing;therapy development;United States Food and Drug Administration;Universities;Work

PROJECT_TITLE: Novel Selective SGLT-1 Inhibitors for Adjunctive Therapy for Cystic Fibrosis Associated Metabolic Diseases


NIH_SPENDING_CATS: Autoimmune Disease;Lung;Orphan Drug;Pulmonary Fibrosis;Rare Diseases;Scleroderma

ORG_CITY: LEXINGTON

ORG_NAME: THENDOR THERAPEUTICS LLC

ORG_STATE: SC

PHR: NARRATIVE Lung fibrosis is a terminal complication of diseases such as idiopathic pulmonary fibrosis (IPF) and systemic sclerosis (SSc). We have identified a peptide with anti-fibrotic activity that is effective at blocking and reversing lung fibrosis. We propose to develop the peptide for the treatment of lung fibrosis.

PI_NAMEs: FEGHALI-BOSTWICK, CAROL A. (contact)

PROGRAM_OFFICER_NAME: VUGA, LOUIS J

PROJECT_TERMS: Amino Acids;Biodistribution;Bleomycin;C-terminal;Cause of Death;Cessation of life;chemical synthesis;Clinic;Collagen;Collagen Type XVIII;Complement Factor B;Complication;Connective Tissue Diseases;cost;Data;Developed Countries;Development;Disease;Disease Progression;Dose;Drug Kinetics;Early Diagnosis;effective therapy;Emotional;Endostatins;Environmental and Occupational Exposure;Environmental Risk Factor;Extracellular Matrix;Failure;FDA approved;Fibrosis;Financial Hardship;Frequencies;Genes;Genetic;Goals;Health Care Costs;Homeostasis;Human;human disease;human tissue;Hydroxyproline;idiopathic pulmonary fibrosis;In Vitro;in vitro activity;in vivo;Infection;intraperitoneal;Lung;Lung Transplantation;Malignant Neoplasms;manufacture;Messenger RNA;Modality;Morbidity - disease rate;mortality;mouse model;Mus;Oral;Organ;Organ Culture Techniques;Organ failure;Organ Transplantation;Patients;Peptides;Pharmaceutical Preparations;Pre-Clinical Model;prevent;Profibrotic signal;Pulmonary Fibrosis;Radiation therapy;response;Scleroderma;side effect;Structure of parenchyma of lung;synthetic peptide;Systemic Scleroderma;Therapeutic;Toxic effect;Transforming Growth Factors;Translating;Variant

PROJECT_TITLE: TT-036 for the treatment of scleroderma-associated pulmonary fibrosis


NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;HIV/AIDS;Infectious Diseases;Prevention;Sexually Transmitted Infections;Women's Health Research

ORG_CITY: SAN FRANCISCO

ORG_NAME: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

ORG_STATE: CA

PHR: PROJECT NARRATIVE Rates of bacterial sexually transmitted infections (STIs) are rising globally, demanding innovative interventions beyond the scope of current efforts to prevent STIs. The DoxyPEP Study has demonstrated the efficacy of doxycycline post-exposure prophylaxis (PEP) among men who have sex with men and transgender women; but puzzlingly, doxycycline PEP was found ineffective in cisgender women in the dPEP study, with preliminary data suggesting the low medication adherence may explain the null result. By study end, we will have developed adherence measurement methods for doxycycline in hair, blood, and urine, and will use these techniques to help interpret the dPEP study, and to examine the relative performance of these methods within the DoxyPEP trial, establishing adherence metrics for current and future rollout studies of doxy-PEP.

PI_NAMEs: SPINELLI, MATTHEW A. (contact)

PROJECT_TERMS: Adherence;Anti-Retroviral Agents;Benchmarking;Biological Assay;Blood;Blood specimen;Caring;cis-female;cis-male;Clinical;clinical predictors;Clinical Trials;cohort;Collection;compliance behavior;condoms;Congenital Syphilis;cost;Data;Databases;demographics;design;Detection;Development;Diagnostic;Directly Observed Therapy;Dose;Doxycycline;Drug Kinetics;Dryness;effective intervention;Enrollment;Epidemic;Estradiol;Estrogens;Frequencies;Future;Gender;gender affirming hormone therapy;Hair;Health;HIV;Immunoassay;Incidence;infection rate;innovation;Intervention;Knowledge;Laboratories;Measurement;Measures;medication compliance;men who have sex with men;Methods;Modeling;Participant;Patient Self-Report;Pattern;Performance;Persons;Pharmaceutical Preparations;Pharmacodynamics;pharmacologic;Pharmacology;pill;Plasma;point of care;point of care testing;pre-exposure prophylaxis;Prevention;Prophylactic treatment;Randomized;Rectum;Reporting;Risk;Role;Sampling;screening;sex;Sex Behavior;Sexually Transmitted Diseases;Spottings;statistics;STI prevention;Techniques;Tenofovir;Testing;Time;time use;transgender women;treatment arm;trend;Unsafe Sex;Urine;Vagina;Visit;Woman;Work

PROJECT_TITLE: Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP

STUDY_SECTION: HIBI

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


ORG_CITY: ITHACA

ORG_NAME: CYTEQUEST, INC.

PHR: Project Narrative Cellular therapies, in which living cells are the drug administered to patients, have the potential to advance treatment for a variety of inherited and acquired diseases. CyteQuest is developing a flexible electroporation platform that can facilitate discovery and easily scale cell therapy manufacturing from the research level to the clinical level. CyteQuest’s goal is to expand the availability of cellular therapy to treat a wider range of diseases and extend treatment to a much broader patient community.

PI_NAMEs: CRAIGHEAD, HAROLD G (contact)

PROGRAM_OFFICER_NAME: TAYLOR, VERONICA

PROJECT_TERMS: Acceleration;Acute Lymphocytic Leukemia;Address;Adopted;Benchmarking;Bypass;CAR T cell therapy;Cell Reprogramming;Cell Survival;Cell Therapy;Cell Volumes;Cells;cellular engineering;Chemicals;chimeric antigen receptor;chimeric antigen receptor T cells;Clinical;clinically significant;Collaborations;Communities;Complex;Computer software;cost;Coupled;CRISPR/Cas technology;cytokine;cytotoxic;Dedications;design;Disease;DNA delivery;Electronics;Electroporation;Engineering;Engraftment;Equipment;flexibility;Generations;Genes;Goals;Good Manufacturing Process;Growth;Head;Hematologic Neoplasms;Human;immunogenicity;improved;in vivo evaluation;Inherited;Insertional Mutagenesis;instrument;Laboratories;leukemia;Liquid substance;manufacture;manufacturing process;manufacturing systems;manufacturing test;Measures;Methods;mouse model;operation;Patients;Pennsylvania;Performance;Pharmaceutical Preparations;Phase;plasmid DNA;Process;Production;programs;Proteins;prototype;Pump;Reagent;Reproducibility;Research;Research Personnel;RNA;Sampling;Scanning;skills;Sterility;System;T-Lymphocyte;Technology;Testing;Time;Transfection;trend;Tube;Universities;Viral;Viral Vector;Virus;voltage;Work

PROJECT_TITLE: Adaptable and scalable electroporation for cellular therapy

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 BBBT-F (10)]


ED_INST_TYPE: UNIVERSITY-WIDE

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

ORG_CITY: Los Angeles

ORG_NAME: UNIVERSITY OF SOUTHERN CALIFORNIA

PHR: PROJECT NARRATIVE The use of unnecessary or potentially harmful medications is a serious problem in older adults, particularly older adults with Alzheimer’s Disease and Related Dementias (ADRD). This project will develop and validate a risk prediction model that identifies older adults with ADRD at greatest need for medication review, will use a registry to monitor medications and risk factors for hospitalization, and will enroll them in a pharmacist-led intervention aimed at reducing potentially inappropriate medications. This proposal will also provide protected time for research and training for Michelle S. Keller, PhD, an early career investigator seeking to be a leader in the field of deprescribing.

PI_NAMEs: KELLER, MICHELLE SOPHIE (contact)

PROGRAM_OFFICER_NAME: SALIVE, MARCEL

PROJECT_TERMS: acceptability and feasibility;Accountability;accountable care organization;Address;Adult;adverse drug reaction;Adverse event;Age;Agreement;Alzheimer's disease related dementia;Appointment;beneficiary;career;career development;Caregivers;Caring;Case Manager;Cessation of life;Cholesterol;Chronic;Chronic Disease;Clinical Trials;community intervention;Contracts;cost;cost effective;Data;Data Analyses;Data Element;design;Development;diabetes management;Diabetes Mellitus;Doctor of Philosophy;effectiveness evaluation;Electronic Health Record;Emergency department visit;Enrollment;Environment;Exclusion;experience;fall risk;falls;feasibility testing;frailty;Future;Geriatrics;Health Care Costs;health care service utilization;Health Personnel;Health Services;Health system;Healthcare Systems;Hemorrhage;High Prevalence;high risk;Hospitalization;Hypertension;Impaired cognition;improved;Informatics;Infrastructure;Inpatients;Institution;Intervention;K-Series Research Career Programs;Life Style;Limited English Proficiency;Measures;Medicare;Medication Management;Mentors;Modeling;Monitor;mortality;multidisciplinary;older adult;Outcome;outreach;participant enrollment;Patient Care;Patients;Pharmaceutical Preparations;Pharmacists;Pharmacoepidemiology;Pharmacy facility;Physicians;pilot test;Polypharmacy;Population;population health;Pragmatic clinical trial;pressure;prevent;Primary Care Physician;primary outcome;professor;programs;Provider;Quality of life;Randomized Controlled Clinical Trials;Randomized, Controlled Trials;Registries;Reproducibility;Research;Research Personnel;Resources;Risk;Risk Factors;risk prediction model;Science;side effect;Testing;Time;Training;Validation;Visit;Work

PROJECT_TITLE: Developing and Testing a Population Health Approach to Deprescribing and Optimizing Medications in Older Adults

STUDY_SECTION: AGCD

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


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

NIH_SPENDING_CATS: Cardiovascular;Clinical Research;Dissemination and Implementation Research;Health Services;Heart Disease;Heart Disease - Coronary Heart Disease;Lung

ORG_CITY: PHILADELPHIA

ORG_NAME: PHRASE HEALTH, INC.

PHR: Project Narrative Clinical decision support (CDS) has the potential to improve patient outcomes by facilitating adherence to evidence-based practices, but it is burdensome to monitor and is oftentimes ineffective as a result. Phrase Health created Outcomes, a process evaluation web-based product to diagnose when and why CDS is not leading to the intended improvements. We are developing an “out of the box” library of quality improvement (QI) project templates for the Outcomes product for the inpatient management of pneumonia, congestive heart failure (CHF), acute myocardial infarction (AMI) and chronic obstructive pulmonary disease (COPD).

PI_NAMEs: TOBIAS, MARC  (contact)

PROGRAM_OFFICER_NAME: BOUGH, KRISTOPHER J

PROJECT_TERMS: Acceleration;Acute myocardial infarction;Address;Adherence;Adoption;Advocate;Agreement;Architecture;care delivery;Chronic Obstructive Pulmonary Disease;Clinical;clinical application;clinical care;clinical decision support;Clinical Practice Guideline;Clinical Trials;cognitive load;cohort;commercialization;Congestive Heart Failure;cost;Data;Data Sources;Diagnosis;Disease;Disease Management;effective intervention;Electronics;Engineering;Environment;evidence base;Evidence based practice;experience;Feedback;Financial cost;financial incentive;Future;graphical user interface;Guidelines;Health;health empowerment;Health system;hospital readmission;Hospitals;improved;improved outcome;Incentives;Inpatients;insight;Intervention;Interview;Investments;Knowledge;Knowledge Discovery;knowledge translation;Libraries;Link;Maps;Marketing;Measures;Meta-Analysis;Methods;Modeling;Monitor;Mus;Myocardial Infarction;novel;Online Systems;Outcome;Patient Care;Patient-Focused Outcomes;Patients;payment;phrases;Pneumonia;Population;Process;process evaluation;programs;Provider;Recommendation;research clinical testing;Sales;Sampling;Services;Sickle Cell Anemia;Site;Structure;support tools;Surveys;System;Time;tool;Traction;Translating;usability;Variant;Walking

PROJECT_TITLE: Establishing a Useful and Usable "Out of the Box" Quality Improvement Library for Enhanced Health System Efficiency and Outcomes

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


NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Dissemination and Implementation Research;Drug Abuse (NIDA only);Electronic Nicotine Delivery Systems;Pediatric;Prescription Drug Misuse;Prevention;Substance Misuse;Substance Misuse Prevention;Tobacco

ORG_CITY: WHITE PLAINS

ORG_NAME: NATIONAL HEALTH PROMOTION ASSOCIATES

PHR: NARRATIVE This SBIR Fast-Track proposal is designed to address the critical public health problem of vaping and prescription drug misuse (PDM) among youth using an evidence-based positive youth development prevention model. We will develop and test a hybrid primary prevention program designed to reduce risk of vaping and PDM among upper elementary utilizing online e-learning modules combined with interactive classroom sessions, based on the evidence-based Life Skills Training model. This research offers the potential to identify an innovative, flexibly designed hybrid prevention program that reduces risk for early-stage substance use behaviors among upper elementary school youth, minimizes time burden in the classroom, and fills a critical gap in primary prevention strategies with an evidence-based approach that can be widely disseminated throughout the country.

PI_NAMEs: WILLIAMS, CHRISTOPHER  (contact)

PROGRAM_OFFICER_NAME: FLOOD, MORRIS

PROJECT_TERMS: Address;Age of Onset;Attitude;Behavior;Behavioral;cohort;commercialization;Community Practice;Control Groups;Country;Data;design;digital technology;Drug Prescriptions;E-learning;Education;Educational process of instructing;Effectiveness of Interventions;effectiveness testing;elementary school;Evaluation;evidence base;Evidence based program;Feedback;flexibility;Focus Groups;follow up assessment;group intervention;hands-on learning;Health education;Hybrids;Informal Social Control;innovation;Intervention;intervention program;Knowledge;Learning Module;Life;Marketing;misuse of prescription only drugs;Modeling;Monitor;Outcome;Parents;Peer Review;Phase;positive youth development;prevent;Prevention;Prevention program;Prevention strategy;preventive intervention;Primary Prevention;process evaluation;programs;protective factors;prototype;Provider;Public Health;Publications;Randomized;randomized trial;Randomized, Controlled Trials;recruit;rehearsal;Reporting;Research;Risk;Risk Reduction;Series;skills;skills training;Small Business Innovation Research Grant;social;Students;substance abuse prevention;substance misuse;substance use;substance use prevention;teacher;Testing;Time;Training;Training Programs;treatment as usual;usability;vaping;Youth

PROJECT_TITLE: A Hybrid Program to Prevent Substance Use Risk among Upper Elementary School Students Using a Positive Youth Development Approach

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


ED_INST_TYPE: SCHOOLS OF PUBLIC HEALTH

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Cost Effectiveness Research;Dissemination and Implementation Research;HIV/AIDS;Health Services;Mental Health;Pediatric;Pediatric - AIDS;Prevention

ORG_CITY: SEATTLE

ORG_NAME: UNIVERSITY OF WASHINGTON

PHR: NARRATIVE Ending the HIV epidemic for youth living with HIV (YLH) will require implementation and optimization of evidence- based interventions that address barriers to treatment. The proposed implementation study will test a youth-led data-driven implementation strategy to scale-up an evidence-based Adolescent Transition Package (ATP) aimed at improving transition processes and post-transition clinical outcomes for YLH in Kenya.

PI_NAMEs: BEIMA-SOFIE, KRISTIN MARIE;JOHN-STEWART, GRACE C. (contact);NJUGUNA, IRENE NYAMBURA;WAMALWA, DALTON CHEKOKO

PROGRAM_OFFICER_NAME: POLLARD-BRANCHARD, SUZANNE LEE

PROJECT_TERMS: acceptability and feasibility;Address;Adolescent;Adoption;Adult;Age;barrier to care;budget impact;care systems;Caring;Cessation of life;chronic care model;Clinic;Clinic Visits;Clinical;Cluster randomized trial;community engaged approach;Consolidated Framework for Implementation Research;cost;cost comparison;cost effective;cost effectiveness;cost estimate;cost-effectiveness evaluation;County;Data;design;Diagnostic;Early Diagnosis;Educational Materials;effective therapy;Effectiveness;effectiveness/implementation design;effectiveness/implementation hybrid;Epidemic;Evaluation;evidence base;Evidence based intervention;Exposure to;Financial cost;Goals;Guidelines;Health;Health Personnel;Health Promotion;health training;HIV;Hybrids;implementation evaluation;implementation framework;implementation science;implementation strategy;implementation study;implementation/effectiveness;improved;improved outcome;incremental cost;Infrastructure;Intervention;intervention cost;intervention delivery;Interview;Kenya;Lead;Learning;Maintenance;markov model;microcosting;Modification;Morbidity - disease rate;Motion;Outcome;pragmatic implementation;Prevention;Procedures;Process;programs;Randomized;randomized, clinical trials;Reach, Effectiveness, Adoption, Implementation, and Maintenance;Readiness;Reporting;Research;scale up;screening;Site;standard of care;Structure;Testing;Time;tool;Trainers Training;Viral;Youth

PROJECT_TITLE: Scale-up of an evidence-based Adolescent Transition Package to support transitional care among youth living with HIV