ORG_CITY: BIRMINGHAM

ORG_NAME: UNIVERSITY OF ALABAMA AT BIRMINGHAM

PHR: Project Narrative Unhealthy alcohol use represents an unaddressed barrier to achieving and maintaining control of the HIV epidemic globally. In the Zambia Alabama HIV Alcohol Comorbidities Program (ZAMBAMA), we will compare the effectiveness of an alcohol brief intervention and a transdiagnostic cognitive behavioral therapy-based model that can address unhealthy alcohol use and a range of comorbid mental health problems to improve HIV and alcohol outcomes among low-resource and underserved patients with HIV and unhealthy alcohol use in sub- Saharan Africa and the Southern United States. ZAMBAMA’s 2 research projects and 3 resource cores were designed for integration and synergy, which will not only strengthen our ability to address our specific aims, but will also create unique scientific opportunities that would not be possible without a program structure.

PI_NAMEs: CROPSEY, KAREN L (contact);VINIKOOR, MICHAEL JEFFREY

PROGRAM_OFFICER_NAME: ROACH, DEIDRA

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;addiction;Address;Adherence;Adult;Africa South of the Sahara;Alabama;alcohol comorbidity;Alcohol consumption;alcohol misuse;Alcohols;antiretroviral therapy;Anxiety;Apache;Arizona;Back;behavioral health;behavioral health intervention;brief alcohol intervention;brief intervention;Businesses;Caring;Clinic;Clinical;Clinical effectiveness;Cognitive Therapy;Collaborations;common treatment;Communities;community clinic;comorbidity;compare effectiveness;Complex;contextual factors;Continuity of Patient Care;cost;cost effective;COVID-19 pandemic;Data;Data Analyses;Data Collection;Data Element;data harmonization;Deep South;design;Diagnostic;Disparity;Disparity population;Educational Intervention;effectiveness testing;Elements;Epidemic;Evidence based intervention;Face;Funding;Gender;Geographic Locations;Health Personnel;HIV;HIV/AIDS;Human Resources;implementation determinants;implementation evaluation;improved;Incidence;Infectious Diseases Research;Interpersonal Violence;Intervention;Knowledge;Licensing;low and middle-income countries;Mental Depression;Mental disorders;Mental Health;Methods;Modeling;Monitor;mortality;National Institute on Alcohol Abuse and Alcoholism;Outcome;Pain;Participant;participant enrollment;Patients;peer;Persons;pilot test;population based;Population Heterogeneity;post-traumatic stress;post-traumatic symptoms;Prevalence;Prevention;Professional counselor;programs;Protocols documentation;Provider;Psychologist;Public Sector;Randomized Controlled Clinical Trials;Randomized, Controlled Trials;reduce symptoms;Research;Research Personnel;Research Project Grants;Resources;response;Rural Population;screening;Southern Africa;Structure;substance use;suicidal risk;synergism;Telemedicine;therapy adherence;Training;Translating;treatment as prevention;treatment effect;Treatment outcome;trial design;Underserved Population;United States;United States National Institutes of Health;Viral;Washington;Zambia


ADMINISTERING_IC: AA

ARRA_FUNDED: N

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Behavioral and Social Science;Brain Disorders;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Mental Health;Mental Illness;Patient Safety;Substance Misuse

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_STATE: AL

PHR: ADMINISTRATIVE CORE PROJECT NARRATIVE The goals of the ZAMBAMA Administrative Core are to 1) Synchronize scientific aims and foster shared scientific progress between the projects; 2) Manage overarching program business and regulatory requirements; and 3) Enhance collaboration among investigators within and outside of the program. Through these aims the core will ensure that the activities of Projects 1 and 2 are harmonized and efficiently supported by the other cores (the Common Elements Treatment Approach [CETA] and Methods and Analysis [MAC] Cores). The Admin Core will optimize the scientific contributions of this Program Project Grant, ultimately advancing the treatment of HIV, unhealthy alcohol use, and mental health comorbidities among people living with HIV in disadvantaged communities.

PI_NAMEs: CROPSEY, KAREN L (contact)

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;addiction;Adverse event;Advisory Committees;Alabama;alcohol comorbidity;Alcohol consumption;alcohol misuse;Alcohols;Amendment;Anxiety;Biological Markers;Businesses;career;Certification;Clinic;Clinical;Clinical Trials Data Monitoring Committees;Cognitive Therapy;Collaborations;Committee Members;Communication;Communities;comorbidity;contextual factors;Coordination and Collaboration;cost;Data Analyses;data dissemination;Data Element;data harmonization;depressive symptoms;Development;Diagnostic;Disadvantaged;Disparity population;effectiveness evaluation;effectiveness testing;Elements;Emergency Situation;Ensure;Event;Faculty;Fostering;Funding;Gender;Goals;Grant;HIV;human subject;implementation determinants;improved;Incentives;Individual;Infectious Diseases Research;Infrastructure;Institution;Institutional Review Boards;International;Intervention;Lead;Manuscripts;meetings;Mental disorders;Mental Health;Mentors;Methods;Monitor;multidisciplinary;National Institute on Alcohol Abuse and Alcoholism;neighborhood disadvantage;next generation;Outcome;Pain;Participant;payment;Persons;Policies;Post-Traumatic Stress Disorders;Postdoctoral Fellow;pre-doctoral;Preparation;Prevention;Program Research Project Grants;programs;Progress Reports;Protocols documentation;Public Sector;Reporting;Research;Research Design;Research Personnel;Research Project Grants;research study;Resource Sharing;Resources;Services;Shipping;substance use;Sum;symposium;Symptoms;Training;Travel;treatment effect;United States National Institutes of Health;Universities;Work;Zambia

PROJECT_TITLE: Admin Core


NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Mental Health;Prevention;Screening and Brief Intervention for Substance Misuse;Substance Misuse

PHR: Project Narrative People with HIV often have unhealthy alcohol use, which can be complicated by psychiatric and substance use comorbidities. The CETA Core within the Zambia Alabama HIV Alcohol Comorbidities (ZAMBAMA) Program will provide clinical oversight for two clinical trials of interventions to address unhealthy alcohol use in patients with HIV in sub-Saharan Africa and the U.S. Deep South. Through training, supervision, and competency assessment activities, the CETA core will help ZAMBAMA understand the intersection of HIV, unhealthy alcohol use, and common comorbidities and evaluate new treatment approaches targeted to people receiving care at under- resourced clinics.

PI_NAMEs: MURRAY, LAURA KAY (contact)

PROJECT_TERMS: Address;Adult;Africa South of the Sahara;Alabama;alcohol comorbidity;alcohol misuse;Alcohols;apprenticeship;brief alcohol intervention;brief intervention;Caring;Clinic;Clinical;Clinical Competence;Clinical Trials;Cognitive Therapy;Collaborations;Communities;comorbidity;Competence;Consultations;Controlled Clinical Trials;cost;Country;Data;Deep South;design;Diagnostic;Disparity population;Educational Intervention;Effectiveness;effectiveness testing;Elements;Epidemic;evidence base;Evidence based treatment;experience;Gender;Goals;Health Personnel;HIV;implementation determinants;improved;Income;innovation;Intervention;Intervention Trial;Knowledge;Licensing;low and middle-income countries;Low income;Manuals;Mental Health;Methods;Modeling;Nature;novel therapeutic intervention;Outcome;Patient Care;Patients;peer;Persons;Population;Problem behavior;Professional counselor;Program Research Project Grants;programs;Provider;provider intervention;Psyche structure;psychiatric comorbidity;Psychiatric therapeutic procedure;Public Health Schools;Randomized Controlled Clinical Trials;Research Project Grants;Resources;Safety;screening;Senior Scientist;Site;substance use;Supervision;Symptoms;synergism;Telemedicine;Training;Training Support;transfer learning;treatment effect;United States;United States National Institutes of Health;Universities;Zambia

PROJECT_TITLE: CETA-CORE


NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Behavioral and Social Science;Clinical Research;Comparative Effectiveness Research;Cost Effectiveness Research;Dissemination and Implementation Research;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Infectious Diseases;Prevention;Screening and Brief Intervention for Substance Misuse;Substance Misuse

PHR: Project Narrative Unhealthy alcohol use represents an unaddressed barrier to achieving and maintaining control of the HIV epidemic both in sub-Saharan Africa and in the rural United States. The Zambia Alabama HIV Alcohol Comorbidities (ZAMBAMA) program will test the effectiveness of two interventions, a brief alcohol intervention (BI) and a transdiagnostic cognitive behavioral therapy-based model called Common Elements Treatment Approach (CETA), in reducing unhealthy alcohol use and mental health comorbidities and in improving HIV outcomes among persons living with HIV in Zambia and Alabama. The Methods and Analysis Core (MAC) will support ZAMBAMA by providing expertise in data collection, management, and analyses within the CHARTZ (CETA HIV Alcohol Reduction Trial in Zambia) and TALC (Telemedicine for unhealthy Alcohol use with CETA) clinical trials, and by leveraging integrated approaches across the trials to create synergistic analyses within the P01 program.

PI_NAMEs: BOSOMPRAH, SAMUEL  (contact)

PROJECT_TERMS: Abstinence;Achievement;Address;Adoption;Africa;Africa South of the Sahara;Alabama;alcohol abstinence;alcohol abuse therapy;alcohol comorbidity;Alcohol consumption;alcohol epidemiology;alcohol intervention;alcohol misuse;Alcohols;Assessment tool;behavior change;Benchmarking;Biological Markers;Biomedical Research;brief alcohol intervention;Caring;Characteristics;Clinic;Clinical;Clinical Trials;Cognitive Therapy;comorbidity;Competence;contextual factors;cost;cost effectiveness;cost-effectiveness ratio;Data;Data Collection;data harmonization;data management;Databases;Diagnostic;Disparity population;Effectiveness;effectiveness evaluation;effectiveness testing;Elements;Ensure;Epidemic;Epidemiologist;Evaluation;experience;Funding;Gender;global health;Head;HIV;Human Resources;implementation determinants;implementation facilitators;implementation outcomes;implementation/effectiveness;improved;incremental cost-effectiveness;Infectious Diseases Research;Information Technology;Institution;International;Intervention;intervention effect;Interview;Laboratories;Measurement;Measures;Mediating;Mediation;Mediator;Mental Health;Methods;Modality;Modeling;multidisciplinary;Outcome;Outcome Measure;Participant;Patient Outcomes Assessments;Patient Self-Report;Persons;phosphatidylethanol;Policies;Practical Robust Implementation and Sustainability Model;primary outcome;Procedures;Professional counselor;Program Research Project Grants;programs;Provider;psychiatric comorbidity;Randomized;Research Methodology;Research Personnel;Resources;Role;Rural;scale up;secondary outcome;Site;Social Desirability;substance use;Symptoms;synergism;Telemedicine;Testing;Therapeutic Intervention;tool;treatment effect;Treatment outcome;underserved area;United States;Universities;Vulnerable Populations;Zambia

PROJECT_TITLE: METHODS AND ANALYSIS CORE


NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;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;Infectious Diseases;Mental Health;Prevention;Screening and Brief Intervention for Substance Misuse;Substance Misuse

PHR: Project Narrative Unhealthy alcohol use represents an unaddressed barrier to achieving and maintaining control of the HIV epidemic in sub-Saharan Africa because best practices for screening and treatment are lacking, existing treatments do not address mental/behavioral health comorbidities, and there are severe shortages of professional mental/behavioral health workers. In this trial, at public sector HIV clinics in Zambia, we will evaluate the effectiveness of two alcohol-reduction interventions, a brief alcohol intervention (BI) and a transdiagnostic cognitive behavioral therapy called Common Elements Treatment Approach (CETA), which can address comorbidities in people with HIV and unhealthy alcohol use, and measure critical implementation data to inform further use of these interventions when integrated into HIV clinical care. This research will advance treatments available to people with HIV in sub-Saharan Africa, which will help achieve individual and public health goals of the HIV response.

PI_NAMEs: VINIKOOR, MICHAEL JEFFREY (contact)

PROJECT_TERMS: 18 year old;Acceleration;Address;Adult;Affect;Africa South of the Sahara;Alabama;Alcohol abuse;alcohol abuse therapy;alcohol comorbidity;Alcohol consumption;alcohol intervention;alcohol misuse;Alcohols;antiretroviral therapy;arm;Behavioral;behavioral health;Biological Markers;brief alcohol intervention;brief intervention;Caring;Clinic;Clinical;clinical care;Cognitive;Cognitive Therapy;comorbidity;comparative effectiveness;Complex;Computerized Medical Record;Continuity of Patient Care;cost;cost effective;cost effectiveness;cost-effectiveness ratio;Counseling;Data;depressive symptoms;design;Diagnostic;Effectiveness;effectiveness evaluation;effectiveness/implementation trial;Elements;Eligibility Determination;Enrollment;Epidemic;epidemic response;evidence base;experience;flexibility;follow-up;health goals;Health Personnel;health related quality of life;HIV;HIV Infections;HIV/AIDS;Hybrids;implementation determinants;implementation evaluation;improved;Incidence;incremental cost-effectiveness;Individual;Intervention;intervention delivery;low and middle-income countries;marginalized population;Measures;Mental disorders;Mental Health;Modeling;mortality;NIH Office of AIDS Research;novel;Outcome;Outcome Measure;Participant;Patient Outcomes Assessments;peer;Persons;Pharmaceutical Preparations;phosphatidylethanol;pilot test;Population;Prevalence;Prevention;Prevention program;Professional counselor;Program Research Project Grants;programs;Protocols documentation;Provider;Psyche structure;psychologic;Public Health;Public Sector;Randomized;Randomized Controlled Clinical Trials;randomized trial;Randomized, Controlled Trials;reduced alcohol use;Research;Research Project Grants;Resource-limited setting;response;screening;standard of care;substance use;Symptoms;Testing;therapy adherence;Translational trial;Trauma;trauma symptom;treatment effect;treatment program;trial design;Viral;Zambia

PROJECT_TITLE: CHARTZ


NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Dissemination and Implementation Research;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Infectious Diseases;Mental Health;Mental Illness;Prevention;Rural Health;Screening and Brief Intervention for Substance Misuse;Social Determinants of Health;Substance Misuse;Telehealth

PHR: Project Narrative Because unhealthy alcohol use and psychosocial comorbidities are obstacles to ending the HIV epidemic in the Deep South, there is a critical need to identify low barrier treatments for these comorbidities in order to end HIV disparities in the U.S. The TALC proposal will test a transdiagnostic behavioral intervention that shows potential as an accessible, cost-effective treatment to reduce these comorbidities and thus improve HIV outcomes among people living with HIV (PLWH) in Alabama. This research will critically advance treatment for unhealthy alcohol use in PLWH in underserved areas, with the potential to greatly reduce HIV disease progression and transmission in high priority areas like Alabama.

PI_NAMEs: EATON, ELLEN FLORENCE (contact)

PROJECT_TERMS: Achievement;Address;Adult;Alabama;alcohol comorbidity;Alcohol consumption;alcohol misuse;alcohol testing;alcohol use disorder;Alcohols;Anxiety;Apache;Area;Arizona;arm;Back;Behavior Therapy;behavioral health;brief alcohol intervention;brief intervention;Caring;Clinic;Clinical;Clinical Research;Cognitive Therapy;Collaborations;Communities;community clinic;Community Healthcare;comorbidity;Complex;Continuity of Patient Care;cost;cost effective;cost effective treatment;cost effectiveness;COVID-19 pandemic;Deep South;depressive symptoms;design;Diagnostic;Diagnostic Procedure;Disease Progression;disease transmission;effectiveness evaluation;effectiveness testing;Elements;Eligibility Determination;Enrollment;Epidemic;epidemic response;evidence base;experience;Funding;Geographic Locations;Goals;Government;Health Personnel;health related quality of life;Health Services;HIV;HIV disparities;HIV Infections;HIV/AIDS;Human immunodeficiency virus test;implementation determinants;implementation evaluation;implementation study;improved;Incidence;International;Intervention;low and middle-income countries;Low income;Measures;Mental Depression;Mental disorders;Mental Health;Modeling;NIH Office of AIDS Research;Opioid;Outcome;Outcome Measure;Participant;Patient Outcomes Assessments;Patient Self-Report;Patients;Persons;poor health outcome;Population;post-traumatic stress;Poverty;Prevalence;Prevention;Professional counselor;programs;Protocols documentation;Provider;psychosocial;Randomized;randomized trial;reduce symptoms;Reporting;Research;Research Activity;Resource-limited setting;routine care;Rural;Schedule;Services;Site;Specialist;Stimulant;substance use;Substance Use Disorder;Suicide prevention;Symptoms;Talc;Telemedicine;telephone delivery;Testing;tool;Training;Translating;transmission process;Transportation;underserved area;United States National Institutes of Health;United States Public Health Service;Viral;Viral Load result;Visit;Washington;Zambia

PROJECT_TITLE: TALC


ADMINISTERING_IC: AG

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Basic Behavioral and Social Science;Behavioral and Social Science;Brain Disorders;Dementia;Neurodegenerative;Neurosciences;Prevention

ORG_CITY: POTOMAC

ORG_NAME: CREATIVE BIO-PEPTIDES, INC.

ORG_STATE: MD

PHR: 8. Project Narrative There is strong evidence of co-morbid pathologies e.g. amyloid β (Aβ), tau and α-synuclein (αSyn) in Alzheimer’s Disease Related Dementias (ADRD) that account for up to 25% of all dementias in patients older than 65 years. Cognitive impairment is closely associated with synapse loss which occurs significantly prior to neuronal loss, suggesting that synaptic dysfunction is the key treatment target, and that ultimately synapse loss by multiple toxic oligomers (αSyn, Aβ, and tau) must be stopped. Creative Bio-Peptides is developing the oral chemokine antagonist peptide RAP-103 to prevent or reverse early synapse loss and cognitive decline in mixed-etiology dementias like ADRDs.

PI_NAMEs: RUFF, MICHAEL R (contact)

PROGRAM_OFFICER_NAME: MARTIN, ZANE

PROJECT_TERMS: Ache;Actins;Age;age related;alpha synuclein;Alzheimer's disease related dementia;Amyloid beta-Protein;Animal Model;animal safety;Animals;antagonist;Antibodies;Area;Astrocytes;Behavioral;Binding;Biological Markers;Blood;Brain;Canis familiaris;CCL2 gene;CCL3 gene;CCR5 gene;Cells;chemokine;chemokine receptor;cholinergic;Clinical;clinical phenotype;cofilin;Cognitive deficits;cognitive performance;comorbidity;Creativeness;cytokine;Dementia;Dendritic Spines;density;design;Development;Disease;Disease Marker;Disease Progression;Dose;effective therapy;Electrophysiology (science);Etiology;Exhibits;Female;Fiber;first-in-human;frontal lobe;Functional disorder;functional restoration;Glial Fibrillary Acidic Protein;Goat;Hippocampus;Histology;Human;human old age (65+);Immunohistochemistry;immunoreactivity;Impaired cognition;in vivo;Inflammation;Inflammatory;Innate Immune System;Interleukin-1 beta;Interleukin-6;Learning;Lewy Body Dementia;male;Measurement;Measures;Membrane;Memory Loss;Messenger RNA;Microglia;mixed dementia;morris water maze;mouse model;mRNA Expression;Mus;Nerve;Nerve Degeneration;Neurofibrillary Tangles;neuron loss;Neurons;novel;older patient;Optics;Oral;Pathologic;Pathology;Patients;Peptides;Performance;Pharmaceutical Preparations;Phase;phase 2 study;Plasma;postsynaptic;pre-clinical;pre-Investigational New Drug meeting;preclinical safety;preclinical study;presynaptic;Presynaptic Terminals;prevent;Production;progression marker;protein activation;Published Comment;RANTES;receptor;Research;response;Rod;Rodent;safety study;Serum;Signal Transduction;Slice;spatial memory;Structure;Synapses;synaptic function;Synaptophysin;System;tau aggregation;tau Proteins;Tauopathies;Testing;Therapeutic;Time;TNF gene;Transgenic Animals;Travel;volunteer

PROJECT_TITLE: A Synapse-Protecting Small Peptide to Treat a-Syn/Tau Mixed Proteinopathies in Alzheimer's Disease Related Dementias (ADRD)

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


ADMINISTERING_IC: GM

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Bioengineering;Biotechnology

ORG_CITY: Half Moon Bay

ORG_NAME: GENNEXT TECHNOLOGIES, INC.

ORG_STATE: CA

PHR: The importance of biopharmaceuticals and membrane protein targets has created a need for improved analytics to facilitate biopharmaceutical research. Our Phase II SBIR proposal will create a needed instrumentation means to study the higher order structure of membrane protein targets as well as other biopharmaceutical drug targets, facilitating proteomics and pharmaceutical research and development. Upon successful completion of our program, we will demonstrate the transformative nature of our new technology to positively impact biopharmaceutical research.

PI_NAMEs: WEINBERGER, SCOT RANDY (contact)

PROGRAM_OFFICER_NAME: SALVADOR MORALES, CAROLINA

PROJECT_TERMS: Adopted;Adoption;adverse drug reaction;Amino Acids;analytical tool;Antibodies;Appearance;Applied Research;aqueous;Behavior;Binding Sites;Biological Process;Biological Products;Biological Response Modifier Therapy;biopharmaceutical industry;chemical reaction;Chemistry;commercialization;Comparative Study;Computer software;computerized data processing;Coumarins;Dangerousness;Data Analyses;detector;dosimetry;Drug Targeting;Environment;experimental analysis;experimental study;Extracellular Protein;Fluorescence;G-Protein-Coupled Receptors;Generations;Goals;Higher Order Chromatin Structure;Human;Hydroxyl Radical;Immune response;improved;instrument;instrumentation;interest;Label;Lasers;Letters;Ligands;Link;Mass Spectrum Analysis;Measures;Membrane Proteins;Microfluidics;Modification;National Institute of General Medical Sciences;Nature;new technology;oxidation;pathogen;pathogenic virus;Patients;Performance;Pharmaceutical Preparations;Pharmacologic Substance;Pharmacology;Phase;Physiologic pulse;Play;Prion Diseases;Process;Production;programs;Protein Conformation;Protein Footprinting;Proteins;Proteome;Proteomics;Reaction;receptor;Reproducibility;Research;research and development;response;Role;Safety;Small Business Innovation Research Grant;Sodium;Source;Structure;success;Surface;System;Techniques;Technology;Testing;Time;tool;Toxin;Transmembrane Domain;Width

PROJECT_TITLE: Multi-Radical Protein Footprinting (MRPF™) Platform

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


ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

ORG_CITY: WESTON

ORG_NAME: VON MEDICAL, INC

ORG_STATE: FL

PHR: PROJECT NARRATIVE Strokes are the second leading cause of death worldwide yet despite improvements to mechanical thrombectomy techniques in recent years, revascularization of occluded vessels is not achieved in up to 33% of cases and only ~50% of cases have good clinical outcomes. Von Medical is developing an innovative aspiration pump to improve revascularization rates following stroke. This pump operates through a unique and novel mechanism that we will show, through the work described in this Phase I proposal, leads to high revascularization rates on the first pass with any diameter catheter currently on the market.

PI_NAMEs: HANSER, MANNING  (contact);STARKE, ROBERT MICHAEL

PROGRAM_OFFICER_NAME: AUBRECHT, TARYN GRACE

PROJECT_TERMS: Acute;Address;Algorithms;American Stroke Association;Animals;Arteries;aspirate;Biological Products;Brain;brain tissue;Cadaver;Caring;Carotid Arteries;Catheters;Cause of Death;Clinic;Clinical;Clinical Trials;clinically relevant;Coagulation Process;cohort;commercialization;Communities;Complement;cost;Data;design;Development;Devices;Diameter;disability;Distal;Early Intervention;Effectiveness;Embolism;Ensure;Evolution;Family suidae;Feedback;Femur;Freezing;functional independence;Generations;Health Care Costs;Healthcare Industry;Hospital Costs;Human;improved;improved outcome;In Vitro;in vitro testing;in vivo;in vivo evaluation;Industry;innovation;internal thoracic artery;Interview;Ischemic Stroke;Kidney;Long-Term Effects;Market Research;Marketing;Measures;Mechanics;Medical;Medical Waste;Modeling;Nature;Neurons;neurovascular;new technology;next generation;Notification;novel;operation;Outcome;Patients;Performance;Personal Satisfaction;Phase;Physicians;Physiological;porcine model;Positioning Attribute;Preclinical Testing;Preparation;Procedures;Property;Pump;Recommendation;Recovery;Reperfusion Therapy;Reporting;revascularization;Safety;Small Business Innovation Research Grant;standard of care;Stents;Stroke;stroke model;success;System;Techniques;Technology;Testing;Thrombectomy;Time;treatment guidelines;Update;usability;Visual;Work

PROJECT_TITLE: Development of a Novel Aspiration Pump for Neurointerventional Procedures

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


ADMINISTERING_IC: VA

FUNDING_MECHANISM: RESEARCH CENTERS

IC_NAME: Veterans Affairs

ORG_CITY: HINES

ORG_NAME: EDWARD HINES JR VA HOSPITAL

ORG_STATE: IL

PHR: Stroke is a leading cause of disability in the United States, affecting ~795,000 people annually. The Veteran's Health Administration provides over 60,000 outpatient visits for stroke-related care annually at a cost of over $250 million. Among ambulatory people with chronic stroke (PwCS), impaired balance is a common health concern that substantially limits mobility (those with the worst balance walk the least). This project will explore adaptive strategies employed by PwCS in balance challenging environments and if a novel gait training intervention using a robotic device to amplify a person's self-generated movements can improve walking balance. The development of effective interventions to increase walking balance among PwCS will positively impact Veterans' health, quality of life, and ability to participate in walking activities.

PI_NAMEs: GORDON, KEITH EDWARD (contact)

PROJECT_TERMS: Acceleration;Address;Affect;Age;Balance training;Biomechanics;Cardiovascular system;Caring;chronic stroke;Clinical Practice Guideline;Clinical Trials;clinically significant;cost;Custom;Development;disability;Educational Intervention;effective intervention;efficacy evaluation;Elements;Ensure;Environment;equilibration disorder;Equilibrium;Exertion;experimental study;Exposure to;Feasibility Studies;Feedback;foot;functional independence;Future;Gait;Gait abnormality;gait rehabilitation;Goals;Health;Heart Rate;improved;Intervention;Lateral;Learning;Locomotor adaptation;Maximum Heart Rate;Measures;Methods;Motion;Motor;motor learning;Movement;novel;Outcome;Outpatients;Pattern;Pelvis;Perception;Persons;Physical activity;post stroke;Protocols documentation;Quality of life;Randomized, Controlled Trials;Recommendation;Rehabilitation therapy;response;Robot;robotic device;Robotics;Speed;Spinal cord injury;Stroke;Time;tool;Training;treadmill;treadmill training;United States;Veterans;Veterans Health Administration;Visit;Walking;walking speed

PROJECT_TITLE: Movement Amplification Gait Training to Enhance Walking Balance Post-Stroke

STUDY_SECTION: RRDS

STUDY_SECTION_NAME: Rehabilitation Research and Development SPiRE Program[RRDS]


ADMINISTERING_IC: AI

ED_INST_TYPE: SCHOOLS OF ARTS AND SCIENCES

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Digestive Diseases;Digestive Diseases - (Peptic Ulcer);Infectious Diseases

ORG_CITY: SANTA CRUZ

ORG_DEPT: PUBLIC HEALTH & PREV MEDICINE

ORG_NAME: UNIVERSITY OF CALIFORNIA SANTA CRUZ

PHR: The proposed research is relevant to public health and specifically to NIH’s mission to seek fundamental knowledge about the behavior of living systems and apply that knowledge to enhance health and reduce the burden of disease. Our experiments will fill a gap in our understanding of basic Helicobacter pylori physiology and metabolism during colonization. This work will pave the way for new treatments that enhance antibiotic cure of H. pylori.

PI_NAMEs: OTTEMANN, KAREN M (contact)

PROGRAM_OFFICER_NAME: BAQAR, SHAHIDA

PROJECT_TERMS: Address;Affect;Antibiotics;Bacteria;Bacterial Infections;Behavior;Binding;Biochemical;Biological Assay;burden of illness;Cancer Etiology;Cancerous;Cessation of life;Chemoreceptors;Chemotaxis;Citrates;Collaborations;colonization resistance;Complement;Crystallization;Crystallography;Cues;Data;Disease;experimental study;extracellular;Frequencies;Fumarates;Gastrointestinal tract structure;gene product;Genes;Genetic Transcription;Gland;Growth;Health;Helicobacter Infections;Helicobacter pylori;host-microbe interactions;Immune;in vivo;Incidence;Individual;Infection;innovation;insight;Knowledge;Ligand Binding;Ligand Binding Domain;Ligands;malignant stomach neoplasm;Measures;Mediating;Metabolic;Metabolism;Methods;Microbe;Mission;Molecular Biology;Molecular Conformation;mouse model;Mucous Membrane;Mus;mutant;Nature;new therapeutic target;novel therapeutics;Organism;Outcome;pathogen;Pathogenesis;Pathogenicity;Persons;Physiology;Play;Population;Population Control;Population Dynamics;pressure;prevent;Process;Proteins;Public Health;receptor;Regulon;Research;Resistance;Resolution;response;Role;Series;Shapes;Signal Transduction;Signaling Molecule;Stomach;Structural Biologist;Structure;Testing;Therapeutic;Tissues;Ulcer;United States;United States National Institutes of Health;Waste Products;Work

PROJECT_TITLE: Research Supplement to Promote Diversity in Health-Related Research: Angela Lane


ORG_CITY: DURHAM

ORG_NAME: INSOMA BIO, INC.

ORG_STATE: NC

PHR: Project Narrative Fat grafting is a compelling option for over 1.6 million Americans in need of soft tissue repair procedures, however surgical harvesting of fat via liposuction destroys its structural integrity and viability, reducing the resilience of the repaired tissue. During this Phase I proposal, inSoma will collaborate with MTF Biologics to develop an off- the-shelf product capable of replicating the results of autologous fat grafting without the need for surgical tissue harvest. The resulting product would expand the range of surgical procedures suited to fat grafting and provide a safer and cost-effective in-office procedure that would eliminate the need for patients to undergo reconstructive surgery.

PI_NAMEs: ROBERTS, STEFAN  (contact)

PROGRAM_OFFICER_NAME: KODURI, SAILAJA

PROJECT_TERMS: Adipocytes;Adipose tissue;Adoption;Adverse effects;Adverse reactions;Allografting;American;Autologous;Autologous Transplantation;Behavior;Biological Products;Biosynthetic Proteins;Blood Vessels;Breast;breast lumpectomy;Cadaver;Clinical;Collaborations;Complement;cost;cost effective;craniofacial;Cues;Defect;design;Development;Diameter;Evaluation;Extracellular Matrix;Face;fat grafting;Fatty acid glycerol esters;Fermentation;Formulation;Foundations;Goals;Grant;Growth;Hand;Harvest;Height;Histologic;Hour;Human;Human body;Implant;in vivo;Industry;Inflammation;Injectable;Injections;Injury;Lead;Letters;Limb structure;lipid biosynthesis;Lipodystrophy;Liquid substance;manufacture;Marketing;minimally invasive;Modeling;Molds;Molecular Weight;Monitor;Musculoskeletal;Necrosis;Needles;Nude Mice;Office Visits;operation;Operative Surgical Procedures;Outcome;Outpatients;Package Insert;Pain;Patients;PECAM1 gene;Performance;perilipin A;Phase;phase 1 study;Phase Transition;Plastic Surgical Procedures;Population;Procedures;Process;programs;Property;Recombinant Proteins;Recommendation;reconstruction;Reconstructive Surgical Procedures;repaired;Resected;resilience;Risk;Safety;scaffold;Scaffolding Protein;Shapes;Silicon;Site;Small Business Innovation Research Grant;soft tissue;Source;Stains;Stream;subcutaneous;success;Suction Lipectomy;Surgeon;Temperature;Testing;Tissue Harvesting;tissue repair;Tissues;Transition Temperature;Transplantation;Variant;Vascularization;wasting;Width

PROJECT_TITLE: An off the shelf alternative to fat transfer for soft tissue repair

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


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Behavioral and Social Science;Cardiovascular;Childhood Obesity;Clinical Research;Heart Disease;Maternal Health;Nutrition;Obesity;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Physical Activity;Pregnancy;Prevention;Sleep Research;Women's Health Research

ORG_CITY: IOWA CITY

ORG_DEPT: PHYSIOLOGY

ORG_NAME: UNIVERSITY OF IOWA

ORG_STATE: IA

PHR: PROJECT NARRATIVE There is growing evidence that maternal health and behaviors in pregnancy, such as pre-pregnancy obesity, excessive gestational weight gain, poor diet, smoking, and adverse pregnancy outcomes, are linked to fetal programming for obesity and cardiovascular disease (CVD) risk in the offspring. Yet, there is a surprising lack of research on the role of prenatal sedentary behavior, physical activity, and sleep (conceptualized together as 24-hour behavior) on offspring obesity risk and CVD risk; this is an unfortunate research gap since there is strong physiological rationale that these behaviors in pregnancy could influence offspring health and are modifiable intervention targets in pregnancy. This multi-site observational cohort study will leverage state-of- the-art, 24-hour behavior assessment in each trimester of pregnancy, collected as part of the ongoing Pregnancy 24/7 cohort study and add additional assessments of offspring growth, adiposity, and CVD risk through 24 months to inform future primordial prevention interventions to decrease the risk of offspring obesity and CVD across the lifespan.

PI_NAMEs: BARONE GIBBS, BETHANY ;WHITAKER, KARA MARIE (contact)

PROGRAM_OFFICER_NAME: DONZE, LAURIE FRIEDMAN

PROJECT_TERMS: Address;Adult;adverse pregnancy outcome;Age Months;Area;Behavior;Behavior assessment;behavior prediction;Birth;Blood Pressure;Body mass index;Cardiovascular Diseases;cardiovascular disorder risk;cardiovascular health;cardiovascular risk factor;Child;Cohort Studies;Data;Development;Diet;Disease;Disparity;early childhood;early onset;Epidemic;Epidemiologic Methods;Face;Family;Family dynamics;Family health status;Family member;fetal programming;Foundations;Future;gestational weight gain;Goals;Growth;Health;Health behavior;Health Promotion;heart disease prevention;Heart Diseases;high risk;Hour;improved;in utero;Incidence;Individual;insight;interest;Intervention;Late pregnancy;life span;Link;Longitudinal Studies;Lung Diseases;Maternal Behavior;Maternal Exposure;Maternal Health;Measures;Medical Records;Mission;modifiable behavior;Monitor;mortality;Mothers;National Heart, Lung, and Blood Institute;novel;Obesity;obesity in children;obesity risk;observational cohort study;offspring;offspring obesity;Outcome;Parents;Participant;Pattern;Persons;Physical activity;Physiologic pulse;Physiological;Play;poor sleep;post pregnancy;postnatal;Postpartum Period;Pregnancy;Pregnancy Trimesters;prenatal;prenatal exposure;prepregnancy obesity;prevent;preventive intervention;primary outcome;prospective;Psychological Factors;Questionnaires;Reduce health disparities;Research;Research Personnel;response;Risk;Risk Reduction;Role;sedentary lifestyle;Site;Sleep;sleep pattern;Smoking;Socioeconomic Factors;Statistical Methods;theories;Time;Toy;Training;trend;Unhealthy Diet;vigorous intensity;Visit;Woman;Work

PROJECT_TITLE: Sedentary behavior, physical activity, and 24-hour behavior in pregnancy and offspring health: the Pregnancy 24/7 Offspring Study Gallagher Diversity Supplement

STUDY_SECTION: LHB

STUDY_SECTION_NAME: Lifestyle and Health Behaviors Study Section[LHB]


ADMINISTERING_IC: CA

ED_INST_TYPE: SCHOOLS OF MEDICINE

IC_NAME: NATIONAL CANCER INSTITUTE

ORG_CITY: PHILADELPHIA

ORG_DEPT: PATHOLOGY

ORG_NAME: UNIVERSITY OF PENNSYLVANIA

ORG_STATE: PA

PHR: Project Narrative The majority of biopsies in both basic and translational cancer studies are preserved in the format of archived formalin-fixed paraffin-embedded (FFPE) samples, and studying tumors in a spatial context will advance understanding of how the complex cross-talk between cancer and surrounding non-cancer cells. Accordingly, spatial omics profiling in archived FFPE tissue can be invaluable for cancer research and potential novel biomarker or molecular regulators discovery. This research proposal will develop a novel technology for spatially resolved co-mapping of epigenome, transcriptome, and proteins in FFPE tissues.

PI_NAMEs: DENG, YANXIANG  (contact)

PROGRAM_OFFICER_NAME: DUECK, HANNAH RUTH

PROJECT_TERMS: Address;Adopted;anti-cancer research;Archives;ATAC-seq;Bar Codes;Biochemistry;Biopsy;Brain;Cancer Biology;cancer subtypes;cell type;Cells;Chromatin;chromatin modification;Clinical;Complex;Consumption;cost;Data;data quality;Data Set;Diagnosis;DNA;Elements;Epigenetic Process;epigenome;epigenomic profiling;experience;Fluorescent in Situ Hybridization;Formalin;Freezing;Functional disorder;Gene Expression;genome-wide;Glioblastoma;Grant;Growth;histone modification;Human;human disease;Image;Immunofluorescence Immunologic;improved;Joints;Malignant - descriptor;Malignant Neoplasms;Maps;Measures;Messenger RNA;Methods;Microfluidics;Molecular;molecular imaging;Motivation;multiple omics;Mus;Neoplasm Metastasis;new technology;next generation sequencing;novel;novel marker;Paraffin Embedding;Pattern;preservation;Proteins;Publishing;Reagent;Reporting;Reproducibility;Research Proposals;Resolution;Resources;Sampling;Scheme;single molecule;Specimen;Stains;Technology;therapy resistant;Time;Tissue Banks;Tissue Embedding;tissue mapping;Tissue Sample;Tissues;transcriptome;transcriptome sequencing;transcriptomics;tumor;tumor heterogeneity;Tumor Tissue;Visit;Work

PROJECT_TITLE: Spatially resolved multi-omics sequencing of FFPE tissues at cellular level

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


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Behavioral and Social Science;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Complementary and Integrative Health;Drug Abuse (NIDA only);Fentanyl Misuse and Addiction;Natural Products;Neurosciences;Opioid Misuse and Addiction;Opioids;Substance Misuse

ORG_CITY: NEW YORK CITY

ORG_NAME: SPARIAN BIOSCIENCES, INC.

ORG_STATE: NY

PHR: NARRATIVE Opioids Use Disorder (OUD) is rapidly growing in the US with a current prevalence of ~5.6M and ~80K opioid-related overdose deaths/year. We propose to develop a novel agent, SBS-226, a partial MOR agonist / DOR antagonist for the treatment of OUD to help curb this rising epidemic with a novel pharmacological therapy.

PI_NAMEs: REICH, JEFFREY  (contact)

PROGRAM_OFFICER_NAME: WHITE, DAVID A

PROJECT_TERMS: Absence of pain sensation;Acute;Address;Agonist;Alkaloids;analog;antagonist;Attention;Automobile Driving;Awareness;Binding;Biological Sciences;Buprenorphine;Chemicals;Chronic Disease;Clinical;Clinical Trials;Country;COVID-19 pandemic;Data;delta opioid receptor;design;Development;Development Plans;Dose;Drug abuse;Drug Kinetics;drug production;Economics;effective therapy;Epidemic;Fentanyl;Fingers;first-in-human;Formulation;Goals;Government;Guidelines;in vivo;innovation;Label;Laws;Lead;lead candidate;Medical;Methadone;Mitragyna;Modeling;Molecular;Morbidity - disease rate;Morphine;Morphine Dependence;mortality;mu opioid receptors;Mus;Naloxone;Names;Natural product discovery;novel;novel therapeutics;Opioid agonist;Opioid Antagonist;opioid epidemic;opioid misuse;opioid overdose;opioid use;opioid use disorder;opioid withdrawal;Oral;overdose death;Pain;Patients;Persons;Pharmaceutical Preparations;pharmacologic;Pharmacotherapy;Phase;phase 1 study;Phase I Clinical Trials;Physical Dependence;Plants;pre-Investigational New Drug meeting;Prejudice;prescription opioid;Prevalence;Process;Property;Public Health;receptor binding;Regulation;Rewards;Risk;Risk Factors;Running;Safety;screening;Series;small molecule;social;social stigma;Societies;Therapeutic;Time;Toxicology;trend;Ventilatory Depression;virtual;Well in self;Withdrawal;Withdrawal Symptom

PROJECT_TITLE: Development of SBS-226, a MOR agonist / DOR antagonist, for OUD

STUDY_SECTION: NIDA

STUDY_SECTION_NAME: Medication Development Research Study Section[NIDA-L]


ADMINISTERING_IC: TR

FUNDING_MECHANISM: OTHER RESEARCH-RELATED

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

NIH_SPENDING_CATS: Behavioral and Social Science

ORG_CITY: CHICAGO

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: NORTHWESTERN UNIVERSITY AT CHICAGO

PHR: Key challenges to the sustenance of a workforce that conducts research which will impact individual and community health include inadequate training (a) in translational science, which is focused on understanding the scientific and operational principles underlying each step of the translational process, and to acquire the unique attributes of a translational scientist, and (b) to advance a culture of inclusive excellence that promotes problem solving and innovation by maximizing contributions from different perspectives and lived experiences. Our overarching goal is to train and nurture diverse clinical and translational scientists to be resilient leaders of high-functioning, interdisciplinary teams, leaders who are well positioned to tackle translational roadblocks, and who employ implementation science principles and partner with communities, affected/interested groups, and end-users.

PI_NAMEs: SHARMA, LEENA  (contact);YANEZ, BETINA

PROGRAM_OFFICER_NAME: RADMAN, THOMAS C

PROJECT_TERMS: Academy;Affect;Archives;Behavioral Sciences;Clinical;Clinical Sciences;Communication;Communities;Competence;Dedications;Development;digital repositories;disability;disadvantaged background;Effectiveness;Ethnic Origin;Evaluation;experience;Faculty;Foundations;Funding;Goals;Health Science Library;Hybrids;implementation science;improved;innovation;Institution;interdisciplinary collaboration;Interest Group;Interview;Knowledge;Leadership;life-long learning;Mentored Clinical Scientist Development Program;Mentors;Modeling;Monitor;Needs Assessment;novel;online delivery;operation;Outcome Assessment;outreach;Pathway interactions;peer;Positioning Attribute;programs;Race;Research;resilience;Series;social;social science research;Structure;tool;Training;Training Programs;Translational Research;translational scientist;Underrepresented Populations;United States National Institutes of Health;Universities

PROJECT_TITLE: NUCATS CTSA K12 Program at Northwestern University

STUDY_SECTION_NAME: Special Emphasis Panel[ZTR1 CI-7 (01)]


ADMINISTERING_IC: ES

IC_NAME: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

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

ORG_CITY: ANN ARBOR

ORG_NAME: BIOMEDWARE

ORG_STATE: MI

PHR: 8. Project Narrative Joinpoint regression developed by the NCI Surveillance Research Program is increasingly used to identify the timing and extent of changes in time series of health outcomes and to project future disease burden. Many analyses of population data (e.g., cancer stage at diagnosis, causes of death, and patterns of health behavior), including those often used in joinpoint regression, are based on percentages or proportions, as the focus is typically on relative, not absolute frequencies. Such time series of compositional variables need to be modeled simultaneously to guarantee the coherency of the individual temporal trends; that is the predicted percentages sum to 100% at each time step. This SBIR project is developing the first commercial software to offer tools for geostatistical noise-filtering and joinpoint regression analysis of time series of compositional variables in epidemiology.

PI_NAMEs: GOOVAERTS, PIERRE E (contact)

PROGRAM_OFFICER_NAME: SHAUGHNESSY, DANIEL

PROJECT_TERMS: Algorithms;analytical tool;Benchmarking;Biology;burden of illness;Cancer Surveillance Research Program;Cause of Death;Computer software;Congresses;County;Data;Data Analyses;Data Reporting;Databases;design;Development;Economics;Epidemiology;Evaluation;experience;Feedback;Frequencies;Future;geochemistry;Geology;Health;Health behavior;Health Sciences;hydrology;Individual;innovation;International;Literature;Malignant Neoplasms;Marketing;Methodology;Methods;Modeling;mortality;Nature;Noise;novel;novel strategies;Outcome;Paper;Pattern;Phase;Population Analysis;Protocols documentation;prototype;Publications;Regression Analysis;Research;Science;Series;simulation;Small Business Innovation Research Grant;software development;Soil;Stage at Diagnosis;Sum;Techniques;Technology;Test Result;Testing;theories;Time;Time Series Analysis;Time trend;tool;Uncertainty;United States National Institutes of Health;usability;user-friendly;Variant;Visualization;Visualization software;Work

PROJECT_TITLE: Software for Geostatistical Smoothing and Joinpoint Regression Modeling of Time Series of Compositional Variables in Epidemiology

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


ED_INST_TYPE: SCHOOLS OF VETERINARY MEDICINE

ORG_CITY: ITHACA

ORG_DEPT: OTHER BASIC SCIENCES

ORG_NAME: CORNELL UNIVERSITY

PHR: Project narrative  Defects in maintaining proteins in the right cellular location results in various human diseases. This program seeks to understand how conserved mechanisms maintain the correct localization of proteins in the secretory pathway in the cell. This knowledge will shed light on the core principles of cell biology and uncover new therapeutic targets.

PI_NAMEs: SARDANA, RICHA  (contact)

PROGRAM_OFFICER_NAME: WAIRKAR, YOGESH PRABHAKAR

PROJECT_TERMS: Anabolism;Cells;Cellular biology;Congenital disorders of glycosylation;Defect;Disease;Enzymes;Eukaryotic Cell;experimental study;Flow Cytometry;Functional disorder;Genetic;Glycoconjugates;Glycolipids;Glycoproteins;glycosyltransferase;Goals;Golgi Apparatus;Health;Homeostasis;Human;human disease;Image;Immune System Diseases;In Vitro;interest;Knowledge;Life;Location;Malignant Neoplasms;Maps;Membrane;Membrane Proteins;Membrane Transport Proteins;Molecular;new therapeutic target;novel;Pathway interactions;Play;Process;programs;Proteins;Proteomics;proteostasis;receptor;receptor recycling;reconstitution;Recycling;Role;solute;sugar nucleotide;Toxin;trafficking;vesicle transport;Virus

PROJECT_TITLE: Molecular mechanisms of membrane protein homeostasis at the Golgi


ADMINISTERING_IC: OH

IC_NAME: NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH

ORG_CITY: LOWELL

ORG_NAME: UNIVERSITY OF MASSACHUSETTS LOWELL

ORG_STATE: MA

PHR: The proposed “Commercial ﬁshing vessel stability and primary preven�on policy” project aims to review Coast Guard vessel loss inves�ga�on reports and to collect key informant interview data to objec�vely assess the desired policy for primary preven�on of vessel instability as a cause of persistent vessel casual�es and disasters. The assessment will document iden�ﬁable barriers to a regular, rou�ne stability assessment of ﬁshing vessels, regardless of age, and produce a strategy for its implementa�on. This work aligns with the interests of the NIOSH/USCG coopera�ve agreement as well as the NORA AFF goals and will be shared with stakeholders of health and safety enforcement and commercial industry.

PI_NAMEs: FULMER, SCOTT  (contact)

PROGRAM_OFFICER_NAME: GARRETT, BRIDGETTE E

PROJECT_TITLE: Commercial fishing vessel stability and primary prevention policy

STUDY_SECTION_NAME: Special Emphasis Panel[ZOH1 DH (02)]


FUNDING_MECHANISM: OTHERS

ORG_NAME: VETERANS HEALTH ADMINISTRATION

PHR: One-third of all Veterans have chronic low back pain (CLBP), and Veterans with CLBP are twice as likely to have co-occurring depression. Compared with the general population, Veterans are both more likely to have CLBP and their pain is more likely to be severe. Even though the proportion of Veterans with medical comorbidities such as diabetes or heart disease is stable or decreasing over time, chronic pain and depression are both increasing. Unfortunately, many Veterans with CLBP (especially those with comorbid depression) experience little to no functional improvement with current treatments. We propose to address this gap by developing an effective and acceptable treatment for Veterans with CLBP and comorbid depression. We will obtain extensive Veteran input during each phase of the project (development, pilot testing, and initial efficacy testing). This work will inform a high-quality clinical trial, thus aligning with the VA Office of Research and Development’s Strategic Research Priority of improving Veterans’ access to high-quality clinical trials.

PI_NAMEs: POWELL, VICTORIA DIANE (contact)

PROJECT_TERMS: Address;alternative treatment;Analgesics;Anesthetics;anti-depressive agents;arm;Behavioral;career;chronic depression;Chronic Disease;Chronic low back pain;chronic pain;chronic pain management;Clinical Sciences;Clinical Treatment;clinical trial analysis;Clinical Trials;Cognitive;comorbid depression;comorbidity;Complex;Control Groups;Data;depressive symptoms;design;Development;Diabetes Mellitus;disability;Distress;Dose;Educational Materials;Effectiveness;efficacy testing;Environment;experience;Feedback;Feeling;Feeling suicidal;flexibility;functional improvement;General Population;Goals;Healthcare;Healthcare Systems;Heart Diseases;Hour;improved;improved outcome;Infusion procedures;innovation;Integrative Therapy;International;Intervention;intervention delivery;intervention effect;Interview;Ketamine;Maintenance;Manuscripts;Medical;Mental Depression;Mental Health;Mentorship;Modeling;Moods;multidisciplinary;open label;Opioid;Pain;Pain intensity;Pain interference;pain reduction;Palliative Care;Participant;Patients;Pattern;Perception;Persons;pharmacologic;Phase;phase 1 study;phase 2 study;Physicians;Pilot Projects;pilot test;Population;Post-Traumatic Stress Disorders;Prevalence;primary outcome;Process;Property;Protocols documentation;psychologic;psychosocial;Psychotherapy;Qualitative Methods;Randomized;Randomized, Controlled Trials;reducing suicide;Reporting;Research;research and development;Research Personnel;Research Priority;Sample Size;Scientist;Series;skills;Structure;Target Populations;Testing;therapy design;therapy development;Time;Training;treatment effect;treatment-resistant depression;Unemployment;United States;United States National Institutes of Health;Veterans;Work

PROJECT_TITLE: Ketamine-assisted integrative treatment for Veterans with chronic low back pain and comorbid depression

STUDY_SECTION_NAME: Special Emphasis Panel[ZRD1 NURP-N (01)]


ORG_CITY: LOS ANGELES

ORG_NAME: CEDARS-SINAI MEDICAL CENTER

PHR: PROJECT NARRATIVE:  Hypertension and cardiovascular disease occur at substantially greater rates in optimally treated people with HIV, though the etiology of this elevated comorbidity risk remains poorly understood. The gut microbiota of people with HIV exhibits a loss of microbes that metabolize dietary fiber into key metabolites that can ameliorate hypertension. We will investigate the dynamics of fiber metabolism and uptake in the setting of HIV, the role of these phenomena in cardiovascular comorbidities, and whether capacity for fiber metabolism can be restored within the HIV-associated gut microbiome.

PI_NAMEs: VUJKOVIC-CVIJIN, IVAN  (contact)

PROGRAM_OFFICER_NAME: OH, YOUNGSUK

PROJECT_TERMS: Anti-Retroviral Agents;antiretroviral therapy;Award;Biological Availability;blood pressure elevation;Cardiovascular Diseases;cardiovascular disorder risk;Cardiovascular Manifestation;Cardiovascular system;catalyst;comorbidity;Computational Biology;Dietary Fiber;effective therapy;Etiology;Exhibits;extend lifespan;Fermentation;Fiber;germ free condition;Gnotobiotic;gut microbiome;gut microbiota;high risk;HIV;Hypertension;Incidence;Individual;Mediating;Metabolism;Methods;Microbe;microbial;microbiota;Modality;Modeling;Mus;Pathway interactions;Persons;Population;Production;Research;Risk;Role;Series;Technology;Testing;Therapeutic;uptake;Volatile Fatty Acids;Work

PROJECT_TITLE: Gut microbiota-mediated fiber fermentation in HIV-associated cardiovascular disease

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 IIDB-P (55)]


ORG_CITY: DEER ISLE

ORG_NAME: REDDE, LLC

ORG_STATE: ME

PHR: Project Narrative: Commercial fishermen spend one third of their lives at sea participating in one of the most dangerous jobs in the world. REDDE Marine Safety offers its clients a “Full Service Safety System” which includes an initial vessel audit inspection followed by periodic mobile service and replacement on all safety equipment and specialized training for operation in northeast fisheries. Our company’s mission is to create a culture of safety among our region’s commercial fishermen.

PI_NAMEs: SHEPARD, PATRICK  (contact)

PROJECT_TITLE: Are you REDDE? Expanding a Mobile Vessel Safety and Training Service for Northeast Fishermen


NIH_SPENDING_CATS: Biotechnology;Lung;Prevention;Pulmonary Hypertension;Rare Diseases;Stem Cell Research;Stem Cell Research - Nonembryonic - Human

ORG_CITY: BALTIMORE

ORG_NAME: UNIVERSITY OF MARYLAND BALTIMORE

PHR: Project Narrative Pulmonary arterial hypertension (PAH) is a disease characterized by abnormal changes to the structure of lung arteries (i.e., ‘remodeling’), and is a major cause of heart failure and death among patients with various disorders of the heart, lung, blood, and connective tissue organ systems. Despite its importance to outcome in patients with PAH, effective therapies that reverse or prevent lung blood vessel remodeling are lacking. We propose an innovative approach that targets the key remodeling protein, NEDD9, selectively using a novel small molecule to establish a potential new treatment for PAH patients.

PI_NAMEs: DHE-PAGANON, SIRANO ;MARON, BRADLEY  (contact)

PROGRAM_OFFICER_NAME: XIAO, LEI

PROJECT_TERMS: 3-Dimensional;Ablation;adverse outcome;Affect;Affinity;analog;angiogenesis;Animal Model;Arterial Disorder;Arteries;arteriole;Attenuated;Binding;Biological Assay;Blood Vessels;Body System;Cancer cell line;Cell Line;Cell Proliferation;cell type;Cells;Cessation of life;Chemicals;Clinical;Complex;Connective Tissue;Data;design;Development;Disease;Distal;effective therapy;Endothelial Cells;Endothelium;Event;Experimental Models;experimental study;Extracellular Matrix;Fibrillar Collagen;Fibronectins;Fibrosis;Fluorescence Recovery After Photobleaching;Focal Adhesion Kinase 1;Focal Adhesions;gain of function;Genetic;Heart Diseases;Heart failure;Hematological Disease;Heparan Sulfate Proteoglycan;Heparitin Sulfate;high risk;Human;Impairment;improved;In Vitro;in vivo;innovation;Integrins;interstitial;ITGA5 gene;kinase inhibitor;Laboratories;Link;liquid chromatography mass spectrometry;loss of function;Lung;Lung Diseases;Malignant Neoplasms;Mass Spectrum Analysis;matrigel;Measures;Mediating;Membrane;Methods;molecular drug target;Morbidity - disease rate;mortality;mutant;nerve stem cell;Neural Groove;Neural Inhibition;novel;Outcome;overexpression;Pathogenesis;Pathway interactions;Patients;peptidomimetics;Pharmaceutical Preparations;Positioning Attribute;prevent;Process;Proliferating;protein complex;protein protein interaction;protein structure;Proteins;Proteomics;pulmonary arterial hypertension;Pulmonary arterial remodeling;pulmonary artery endothelial cell;Pulmonary Heart Disease;pulmonary vascular remodeling;Pulmonary Vascular Resistance;right ventricular failure;Scaffolding Protein;SH3 Domains;Signal Transduction;Small Interfering RNA;small molecule;Specificity;Structure;Sulfhydryl Compounds;targeted treatment;Testing;Time;Tissues;Vascular Endothelial Growth Factors;Vascular Proliferation;Vascular remodeling;X-Ray Crystallography

PROJECT_TITLE: Targeting FAK-NEDD9 protein-protein interaction to prevent focal adhesion assembly and vascular proliferation in pulmonary arterial hypertension

STUDY_SECTION: MSFA

STUDY_SECTION_NAME: Macromolecular Structure and Function A Study Section[MSFA]


NIH_SPENDING_CATS: Acute Respiratory Distress Syndrome;Bioengineering;Infectious Diseases;Lung;Patient Safety;Prevention;Rare Diseases

ORG_CITY: PITTSBURGH

ORG_NAME: RESPAIR, INC.

PHR: Project Narrative Every year silent aspiration during ventilation leads to nearly 500,000 pulmonary infections with a mortality rate of 1 in 3, adding more than $8 billion to healthcare spending in the United States. Respair is developing a novel endotracheal tube with ultra-soft baffles (thin, flexible discs) attached to the tube to create a seal that prevents silent aspiration while putting less force on the airway than current balloon sealing mechanisms. Respair aims to validate the baffle design through FDA verified safety and usability tests that will support the commercialization of a new device for patients on ventilators and create a technology platform for airway device innovation that further improves patient outcomes and reduces healthcare costs.

PI_NAMEs: BERESFORD, ROSS  (contact)

PROGRAM_OFFICER_NAME: SHENOY, SIDDHARTH KAUP

PROJECT_TERMS: 3D Print;Address;Adopted;Adoption;Adult;Area;aspirate;Award;Breathing;Cadaver;Clinical;commercialization;comparative;Coughing;Critical Care;Critical Pathways;Data;Death Rate;Decision Making;design;Development;Devices;endotracheal;Ensure;Environment;Excision;flexibility;Foundations;Freezing;Future;Health Care Costs;Healthcare;human error;improved;improved outcome;Infection;infection risk;innovation;Interview;Larynx;Licensing;Liquid substance;Lung;Lung infections;lung injury;manufacture;Manufacturer;Maps;Measures;Mechanical ventilation;Medical Device;meetings;migration;Modeling;mortality;Nosocomial Infections;novel;Outcome;Particulate;Patient Care;patient response;Patient-Focused Outcomes;Patients;Phase;Predisposition;Preparation;pressure;prevent;Production;Protocols documentation;prototype;Regulatory Pathway;Risk Reduction;Safety;safety and feasibility;safety testing;seal;Small Business Innovation Research Grant;success;technology platform;Testing;Thinness;Trachea;Trauma;Tube;United States;usability;ventilation;Ventilator;vocal cord;Work

PROJECT_TITLE: RelianceET: a novel endotracheal tube design with a superior sealing mechanism to improve clinical efficiency and reduce lung injury and infection for patients.

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


NIH_SPENDING_CATS: Cancer;Clinical Research;Clinical Trials and Supportive Activities;Dental, Oral, and Craniofacial Disease;Emerging Infectious Diseases;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Microbiome;Rare Diseases

ORG_CITY: Aurora

ORG_DEPT: MICROBIOLOGY/IMMUN/VIROLOGY

ORG_NAME: UNIVERSITY OF COLORADO DENVER

ORG_STATE: CO

PHR: Project Narrative In sub-Saharan Africa, where Kaposi’s sarcoma-associated herpesvirus (KSHV) seroprevalence and HIV incidence are highest in the world, the effects of the oral environment on oral KSHV reactivation and shedding in people living with HIV (PLWH) before Kaposi’s sarcoma (KS) development are unknown. We propose the first and largest longitudinal study to our knowledge that will assess the effects of oral health, oral environment, and the oral microbiome on KSHV reactivation and shedding in rural Ugandan adults living with and without HIV infection. We will leverage an experienced multi-disciplinary team, a strong study design, and innovative and validated research techniques to identify the effects of the oral environment on KSHV reactivation in PLWH, a profound knowledge gap integral to identifying pre-risk measures for oral cavity KS involvement and developing prevention tactics in the region most affected.

PI_NAMEs: SABOURIN, KATHERINE R (contact)

PROGRAM_OFFICER_NAME: DOMINGUEZ, GERALDINA

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Adult;Affect;Africa South of the Sahara;antiretroviral therapy;Area;Automobile Driving;Award;Caring;catalyst;Clinic;cohort;Data;Development;dysbiosis;Enrollment;Environment;Etiology;Exhibits;experience;Female;Foundations;General Population;Gingivitis;Healthcare;high risk population;HIV;HIV Infections;Human Herpesvirus 8;Immune;Immune response;Immunoglobulin A;Incidence;inflammatory marker;innovation;Intervention;Kaposi Sarcoma;Knowledge;Liquid substance;Longitudinal Studies;male;Malignant Neoplasms;Measures;mortality;Mouth Diseases;Mucositis;multidisciplinary;Newly Diagnosed;Oral;Oral cavity;Oral health;oral lesion;oral microbiome;Oral mucous membrane structure;Palate Kaposi's Sarcoma;Participant;Pathogenesis;Patients;Periodontitis;Persons;Prevention;Research;Research Design;Research Technics;Resolution;Ribosomal RNA;Risk;Role;Rural;Rural Population;Saliva;Seroprevalences;Techniques;Testing;Therapeutic;Uganda;Viral Load result

PROJECT_TITLE: Effects of the oral environment on KSHV shedding in Ugandan adults living with HIV


NIH_SPENDING_CATS: Biotechnology;Cost Effectiveness Research;Lung;Orphan Drug;Pulmonary Fibrosis;Rare Diseases

ORG_CITY: CAMDEN

ORG_NAME: VASARYA THERAPEUTICS, INC.

ORG_STATE: DE

PHR: Project Narrative This proposal focuses on the development of an IND-enabling drug candidate as a novel means to treat pulmonary fibrosis, an incurable disease with poor treatment options for patients. We will optimize and develop a drug candidate based on our tool compound that demonstrates anti-fibrotic activity through targeting a unique disease-associated cryptic epitope within diseased extracellular matrix.

PI_NAMEs: HU, PING  (contact)

PROGRAM_OFFICER_NAME: VUGA, LOUIS J

PROJECT_TERMS: Adverse effects;Affinity;Animal Model;Antibodies;Antibody Binding Sites;Binding;Biological Assay;candidate selection;Cell surface;Cell Surface Receptors;Cicatrix;Clinical Research;Cryoultramicrotomy;cytotoxicity;Data;Deposition;design;Development;Diagnosis;Disease;Dose;drug candidate;drug efficacy;ECM receptor;effective therapy;efficacy evaluation;efficacy study;Epitopes;Evaluation;Excision;Extracellular Matrix;FDA approved;Feedback;Fibroblasts;fibrogenesis;Fibronectins;Fibrosis;Formulation;functional improvement;Future;Goals;Human;idiopathic pulmonary fibrosis;Immunoglobulin G;improved;In Vitro;in vivo;Integrin alphaV;Integrins;Interruption;Intracellular Signaling Proteins;Length;Life;Lung;manufacture;Maps;Mediating;Methods;mimetics;Molecular Conformation;mouse model;mutation screening;Myofibroblast;nintedanib;novel;novel strategies;novel therapeutic intervention;novel therapeutics;Patients;Pharmaceutical Preparations;pharmacokinetics and pharmacodynamics;Phase;Pirfenidone;Process;Production;Proteins;Pulmonary Fibrosis;Quality-Adjusted Life Years;receptor;Research;Resolution;Reticulum;RGD (sequence);Risk;Safety;safety study;Series;Serious Adverse Event;side effect;Site;Small Business Innovation Research Grant;Specificity;Stains;Structure of parenchyma of lung;System;Testing;Therapeutic;Tissues;tool;Toxic effect;Transforming Growth Factor beta;Translating;Validation;Variant;wound healing

PROJECT_TITLE: Translating a Novel Therapeutic Approach to the Treatment for Idiopathic Pulmonary Fibrosis


ORG_NAME: VA GREATER LOS ANGELES HEALTHCARE SYSTEM

PHR: Narrative Sleep disorders are among the most common reasons for seeing a physician and chronic insomnia, which greatly increases the risk of suicide, is by far the most common sleep disorder. Our recent work suggests that sleep in the natural world is linked to daily and seasonal temperature rhythms and that the rhythmic alternation of nonREM and REM sleep is driven by the brainstem thermoregulation. Disruption of these rhythms may be responsible for insomnia and hypersomnia and a better understanding of these rhythms may lead to more effective treatment of these sleep disorders by regulating environmental temperature.

PI_NAMEs: SIEGEL, JEROME M (contact)

PROJECT_TERMS: Adult;Affect;Age Months;Air;Air Conditioning;alertness;Animals;attenuation;Bilateral;Binding;Birth;Brain;brain metabolism;Brain Stem;Cessation of life;Chronic Insomnia;Consumption;Darkness;Development;Devices;Dolphins;Dorsal;effective therapy;Electroencephalography;Energy consumption;Environment;Exhibits;experience;falls;Female;Fur Seals;Generations;Heating;Hour;Human;Hypersomnias;Hypothalamic structure;Implant;implantation;Incidence;Individual;Industrialization;Investigation;Laboratories;Laboratory Animals;Life;Light;Link;male;Mammals;Membrane;Metabolism;Microdialysis;Modeling;Modernization;Narcolepsy;Newborn Infant;non rapid eye movement;older adult;Operative Surgical Procedures;Periodicity;Physicians;Physiologic Thermoregulation;Pontine structure;Population;power analysis;Prosencephalon;Rattus;REM Sleep;Rest;Role;Seasons;sex;Site;Sleep;Sleep Disorders;Sleep disturbances;Sleep Fragmentations;Sleeplessness;Societies;Specific qualifier value;suicidal risk;System;Techniques;Temperature;Testing;Time;Variant;Video Recording;Water;Whales;wireless;Work

PROJECT_TITLE: Sleep and Brain Thermoregulation

STUDY_SECTION_NAME: Special Emphasis Panel[ZRD1 NURR-H (01)]


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Bioengineering;Biotechnology;Coronaviruses;Coronaviruses Vaccines;Emerging Infectious Diseases;Genetics;Immunization;Infectious Diseases;Influenza;Nanotechnology;Pneumonia and Influenza;Prevention;Vaccine Related

ORG_CITY: MOBILE

ORG_NAME: COMPOVAX, LLC

PHR: PROJECT NARRATIVE mRNA vaccines have led the way in controlling the COVID 19 pandemic in the United States and have the potential to be a rapid effective way to control other emerging infectious threats throughout the world. This proposal will test a novel design for an mRNA vaccine that is significantly less expensive and easier to produce than current mRNA vaccines.

PI_NAMEs: FOUTY, BRIAN W (contact)

PROGRAM_OFFICER_NAME: GORDON, JENNIFER L

PROJECT_TERMS: 2019-nCoV;Accounting;Agreement;Alabama;Animal Model;Antigens;Complex;cost;Cost Control;cost estimate;COVID-19 pandemic;Data;design;Development;DNA;Dose;Exonuclease;Exposure to;Formulation;Genetic Transcription;Hemagglutinin;Immune response;Immunize;improved;In Vitro;Inbred BALB C Mice;Influenza A virus;Influenza Hemagglutinin;Intellectual Property;Internal Ribosome Entry Site;Length;Licensing;lipid nanoparticle;Membrane Proteins;Messenger RNA;Moderna COVID-19 vaccine;Modification;mRNA lipid nano particle vaccine;Mus;novel;Paper;Pfizer-BioNTech COVID-19 vaccine;Phase;Poly A;Poly(A) Tail;Production;protective efficacy;protein expression;Proteins;Publications;Research Personnel;respiratory pathogen;RNA;RNA vaccination;RNA vaccine;SARS-CoV-2 spike protein;Small Business Technology Transfer Research;spleen exonuclease;Structure;success;System;Testing;Therapeutic;Transcript;Translation Initiation;Translations;United States;Universities;Vaccination;vaccine platform;Vaccines;vector

PROJECT_TITLE: Capless mRNA for use as a vaccine

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


ADMINISTERING_IC: DC

IC_NAME: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

NIH_SPENDING_CATS: Genetics;Hearing Loss;Neurosciences;Physical Injury - Accidents and Adverse Effects;Prevention

ORG_CITY: SAN FRANCISCO

ORG_DEPT: OTOLARYNGOLOGY

ORG_NAME: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

PHR: PROJECT NARRATIVE Noise-induced hearing loss affects nearly 40 million Americans. We have newly identified a pathway critically involved in the ear's early response to loud sound. In this grant, we aim to learn more about how this pathway is involved in hearing and deafness, so that we may develop drugs to target this pathway and prevent hearing loss.

PI_NAMEs: CHAN, DYLAN  (contact)

PROGRAM_OFFICER_NAME: CYR, JANET

PROJECT_TERMS: Affect;American;Apoptosis;Apoptotic;Biochemical;Calcium;Cell Death;Cell Line;Cell Survival;Cells;Cellular Stress;Clinical;Cochlea;conditional knockout;Critical Pathways;Cytoplasm;deaf;deafness;Development;Ear;Endoplasmic Reticulum;experimental study;Family;Foundations;Functional disorder;Genes;Genetic;genetic deafness;Genetic Techniques;Genetic Transcription;Grant;Hair Cells;Hearing;hearing impairment;Homeostasis;Hour;Human;Image;Impairment;in vivo Model;insight;Knock-out;Knockout Mice;Learning;Link;Loudness;Macromolecular Complexes;Mediator;Messenger RNA;Modeling;multidisciplinary;Mus;Noise;noise exposure;Noise-Induced Hearing Loss;normal hearing;novel;Pathway interactions;Pattern;Pharmaceutical Preparations;pharmacologic;Physiological;Predisposition;prevent;prevent hearing loss;Proteins;Public Health;release of sequestered calcium ion into cytoplasm;response;reuptake;Role;sound;Supporting Cell;targeted treatment;therapeutic target;Time;Trauma;Up-Regulation;Variant;Wild Type Mouse

PROJECT_TITLE: The role of TMTC4, endoplasmic reticulum Ca2+ flux, and the unfolded protein response in noise-induced hearing loss


ORG_CITY: ALACHUA

ORG_NAME: FOUNDATION FOR APPLIED MOLECULAR EVOLUTN

PHR: NARRATIVE  Cancer research is often driven by hypotheses that see a specific extracellular protein as important for the disease, hypotheses often tested by developing an antibody to that protein. The technology to be developed here will create a new capability, reagents that not only bind a target protein, but also cleave it, to be available from suppliers in weeks (not months) at 10-100 fold lower cost than antibodies. In addition to having a transformative impact on cancer research, the hitherto unavailable properties of this new reagent class may make them eventually available for cancer diagnostics, to guide therapy, or as therapeutic agents.

PI_NAMEs: BIONDI, ELISA  (contact)

PROGRAM_OFFICER_NAME: JOHNSON, ERIC MICHAEL

PROJECT_TERMS: Acids;Affinity;Amino Acids;Analytical Chemistry;Animals;Ankyrins;Anthrax disease;anthrax protective factor;anti-cancer research;Antibodies;Antibody Affinity;Antibody-drug conjugates;aptamer;base;Benchmarking;Binding;Biological;Biological Assay;Biopolymers;Blood;Breast Cancer Cell;cancer cell;Cancer Diagnostics;Catalysis;Cell Culture Techniques;Cell surface;Cells;chemical group;chemical synthesis;Clinical Laboratory Information Systems;Communities;comparative efficacy;Complex;cost;Diagnostic;Digestion;Disease;DNA;DNA-Directed RNA Polymerase;Drug Kinetics;empowerment;Evolution;extracellular;Extracellular Protein;falls;functional group;genetic information;Hand;Image;Immune system;Immunoglobulin G;Impairment;improved;In Vitro;in vivo;Information Systems;Laboratories;Laboratory Study;Letters;Libraries;Liquid substance;Literature;Malignant Breast Neoplasm;Malignant neoplasm of liver;Malignant Neoplasms;Mammalian Cell;manufacture;Modification;Molecular;Molecular Biology;Monoclonal Antibodies;new technology;nuclease;Nucleotides;Oligonucleotides;Pathway interactions;Peptides;Performance;Phage Display;Pharmaceutical Preparations;Polymerase;polypeptide;Preparation;Production;programmed cell death ligand 1;Property;protein degradation;Protein Fragment;Proteins;Reaction;Readiness;Reagent;recruit;Reproducibility;Research;Research Personnel;RNA;RNA-Directed DNA Polymerase;Role;Route;Services;Specificity;System;targeted cancer therapy;Technology;technology development;Testing;Therapeutic;Therapeutic Agents;Therapeutic antibodies;Time;Tissues;tool;Work

PROJECT_TITLE: Evolved Molecules that Destroy Cancer Relevant Proteins


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Kidney Disease

ORG_CITY: DALLAS

ORG_NAME: UT SOUTHWESTERN MEDICAL CENTER

ORG_STATE: TX

PHR: Project Narrative This institute aims to engage and train the next generation of kidney disease researchers. Students attend didactic lectures, lab courses and gain hands on lab experience at the hands of world-class researchers in one of the most exciting research institutions in the country. We will attempt to train 14 students per year for the duration of the grant.

PI_NAMEs: CARROLL, THOMAS JOSEPH (contact);HUEN, SARAH

PROGRAM_OFFICER_NAME: MARIC-BILKAN, CHRISTINE

PROJECT_TERMS: Academy;Acute;Adult;American;Anatomy;Biomedical Research;career;Career Choice;career development;Childhood;Chronic Kidney Insufficiency;Clinic;clinical investigation;Counseling;Country;Dialysis procedure;Disease;Epidemic;Event;experience;Exposure to;Faculty;Funding;Future Generations;Goals;Grant;grasp;Hand;hands on research;Healthcare Systems;Institution;interest;Kidney;kidney biopsy;Kidney Diseases;Kidney Transplantation;Knowledge;laboratory experience;Learning;lectures;Measures;Medical;Medical center;Medicine;member;Mentorship;Mind;nephrogenesis;Nephrology;next generation;Participant;Physiology;professor;programs;recruit;Renal function;Research;Research Institute;Research Personnel;Series;social organization;Societies;student mentoring;student participation;Students;success;symposium;teacher;therapy development;Time;Training;translational goal;Travel;Uncertainty;undergraduate research;undergraduate student;United States;United States National Academy of Sciences;Visit

PROJECT_TITLE: UTSW Summer Undergraduate Research Institute for the Study of Kidney Diseases

STUDY_SECTION: DDK

STUDY_SECTION_NAME: Kidney, Urologic and Hematologic Diseases D Study Section[DDK-D]


NIH_SPENDING_CATS: Behavioral and Social Science;Brain Disorders;Clinical Research;Dissemination and Implementation Research;Drug Abuse (NIDA only);Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Mental Health;Networking and Information Technology R&D (NITRD);Pediatric;Prevention;Primary Health Care;Rural Health;Social Determinants of Health;Substance Misuse;Telehealth

ORG_CITY: EUGENE

ORG_NAME: NORTHWEST PREVENTION SCIENCE INC

ORG_STATE: OR

PHR: Project Narrative This application focuses on examining the feasibility and commercial potential of an asynchronous, online training for a digital, web-based application for families of children at-risk for substance use in a range of community health settings. By interviewing providers, developing an online training program, and conducting usability and feasibility testing, we plan to evaluate a training model for the Family Check-Up Online product in order to promote wide-scale dissemination of this evidence-based treatment to community mental health and primary care organizations.

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

PROGRAM_OFFICER_NAME: FLOOD, MORRIS

PROJECT_TERMS: acceptability and feasibility;Address;Adolescence;Adolescent and Young Adult;adolescent substance abuse;adolescent substance use;Adult;Aggressive behavior;antisocial behavior;Anxiety;Area;Businesses;Cannabis;Certification;checkup examination;Child;Child Behavior;Child Care;Child Rearing;Childhood;Clinical Trials;commercialization;Communities;Community Health;community setting;Conflict (Psychology);cost;Country;Coupled;COVID-19;design;Development;digital;digital health;digital intervention;Dissemination and Implementation;early childhood;Effectiveness;eHealth;Emotional;Epidemic;Evaluation;evidence base;Evidence based intervention;Evidence based treatment;experience;Family;Family Relationship;family support;feasibility testing;Feedback;Goals;Health Personnel;Health Technology;Healthcare;high risk;implementation fidelity;improved;indexing;Inequity;Informal Social Control;interest;Intervention;Interview;Knowledge;Legal;Letters;Marketing;Mental Depression;Mental Health;Mental Health Services;Methodology;Methods;mHealth;middle childhood;Modeling;motivational enhancement therapy;National Institute of Drug Abuse;online intervention;Online Systems;opioid use;Oregon;Outcome;Parents;Pathway interactions;Phase;Population;Poverty;prevent;Prevention;Prevention program;Preventive;Preventive care;Primary Care;Problem behavior;Process;product development;programs;Provider;Recreation;recruit;Research;response;Risk;Risk Behaviors;Risk Factors;Risk Reduction;Rural Community;satisfaction;Schools;Self Efficacy;Series;Services;Site;skills;social health determinants;Stress;stress management;stress reduction;Substance abuse problem;substance use;Substance Use Disorder;substance use treatment;success;telehealth;Testing;Time;Training;Training Activity;Training Programs;Transportation;trauma exposure;usability;web app;Youth

PROJECT_TITLE: The Family Check-Up Online: Development of an asynchronous training program for providers to enhance wide-scale dissemination

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


ADMINISTERING_IC: HD

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

NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Clinical Research;Clinical Trials and Supportive Activities;Contraception/Reproduction;Dissemination and Implementation Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Networking and Information Technology R&D (NITRD);Prevention;Women's Health Research

ORG_CITY: Lancaster

ORG_NAME: OVARYIT, LLC

PHR: Modified Public Health Relevance Section  Pharmacist-prescribed contraceptive services have the potential to lower the rate of unplanned pregnancy in the US, however, several barriers must be addressed to enable widespread adoption. During Phase I, the OvaryIt Platform proved itself as a smart, contraceptive-specific electronic health record (EHR) system with embedded clinical decision support (CDS) tools to increase workflow efficiencies and assist pharmacists in delivering safe, high-quality contraceptive care to patients. The successful completion of this SBIR Phase II project is expected to result in the creation and commercialization of an end-user-driven SaaS platform that facilitates the adoption of pharmacist-prescribed contraceptive services.

PI_NAMEs: KUCEK, MARY  (contact)

PROGRAM_OFFICER_NAME: POPKIN, RONNA

PROJECT_TERMS: Address;Adopted;Adoption;Agreement;Caring;Client satisfaction;Clinical;clinical decision support;Clinical Decision Support Systems;combat;commercialization;commercialization readiness;Contraceptive Agents;contraceptive efficacy;Contraceptive Usage;cost;cost effective;County;Data;design;Development;District of Columbia;Economics;Education;Electronic Health Record;electronic health record system;Eligibility Determination;empowerment;Expenditure;Family;Family Planning;Feedback;Foundations;Frustration;Gender;Government;Guidelines;Health;health inequalities;Health Services Accessibility;Health system;improved outcome;Incentives;Inequity;interest;Length;Licensing;Life Cycle Stages;Maternal Mortality;Medical;Modification;Oral Contraceptives;Paper;Participant;Patient Self-Report;Patient-Focused Outcomes;Patients;performance tests;Pharmacists;Pharmacy facility;Phase;phase 1 study;Physicians;platform as a service;Population;Pregnancy Rate;prevent;profiles in patients;Progestins;programs;prototype;Provider;Psyche structure;Recurrence;Risk;Safety;Sampling;Services;Small Business Innovation Research Grant;social;software as a service;software development;Standardization;support tools;Surveys;System;Testing;unintended pregnancy;United States;United States Food and Drug Administration;United States Supreme Court;Universities;usability;Utah;Woman;Work;Workload

PROJECT_TITLE: Development and commercialization of support tools to promote safety and adoption of pharmacist prescribed contraceptive services.


ADMINISTERING_IC: PS

IC_NAME: NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STD AND TB PREVENTION

ORG_NAME: LURIE CHILDREN'S HOSPITAL OF CHICAGO

PHR: PROJECT NARRATIVE Black women experience one of the highest incidences of HIV among all U.S. subpopulations and despite national PrEP implementation efforts, uptake among Black women remains low with only 10% who could benefit from PrEP prescribed it in 2020. Given the 2021 PrEP guidance to inform all sexually active patients of PrEP and 2022 FDA approval of cabotegravir injections, it is essential that health systems implement interventions to increase PrEP uptake and improve persistence among Black women. Project PrOVIDE: PrEP Optimization Via Implementation, Dissemination, and Evaluation will evaluate implementation strategies to address barriers and increase uptake of and persistence on PrEP among Black cisgender women in six distinct counties.

PI_NAMEs: JOHNSON, AMY KRISTEN (contact)

PROJECT_TITLE: RFA-PS-23-001 - Project PrOVIDE: PrEP Optimization Via Implementation, Dissemination, and Evaluation


ADMINISTERING_IC: IP

IC_NAME: NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES

ORG_CITY: NEW DELHI

ORG_COUNTRY: INDIA

ORG_FIPS: IN

ORG_NAME: ALL-INDIA INSTITUTE OF MEDICAL SCIENCES

PHR: Project Narrative This study will generate information on health system and economic impact of Influenza and SARSCoV-2 related severe acute respiratory infections among adults in India. Such information from Low-middle income countries is sparse. In addition, this will strengthen capacity among the participating institutions to conduct disease registries and cohort to assess long-term sequelae of such infections. The evidence so generated will be disseminated to provincial and national government through a well thought out advocacy strategy leading to mitigation of the impact of these two infections in the community.

PI_NAMEs: KRISHNAN, ANAND  (contact)

PROJECT_TITLE: RFA-IP-22-001 - Burden and sequelae of influenza, SARS-CoV-2 and other respiratory viruses associated Severe Acute Respiratory Infections among Indian adult population aged 18-60yrs


ADMINISTERING_IC: GH

IC_NAME: Center for Global Health

ORG_CITY: LIVERPOOL

ORG_COUNTRY: UNITED KINGDOM

ORG_FIPS: UK

ORG_NAME: TMLIVERPOOL SCHOOL OF TROPICAL MEDICINE

ORG_ZIPCODE: L3 5QA

PHR: PROJECT NARRATIVE This CoAg supports a collaboration between the Kenya Medical Research Institute (KEMRI), the US CDC and the Liverpool School of Tropical Medicine (LSTM) to support the Kenyan Ministry of Health to achieve major reductions in the malaria burden in areas with intense year-round transmission in western Kenya by 2025. The partnership will support the expansion of the malaria surveillance infrastructure to track the progress towards malaria transmission targets, evaluate different combinations of area-wide interventions targeting the malaria vector and asymptomatic parasite reservoir to reduce malaria transmission and strengthen case management. These activities will provide pivotal critical scientific knowledge to inform and guide malaria program implementation and reduce malaria-associated morbidity and mortality through the identification and scale-up and continued evaluation of evidence-based intervention strategies.

PI_NAMEs: TER KUILE, FEIKO OLAF (contact)

PROJECT_TITLE: RFA-GH-20-002, Malaria Operations Research to Improve Malaria Control and Reduce Morbidity and Mortality in Western Kenya


ADMINISTERING_IC: FD

IC_NAME: FOOD AND DRUG ADMINISTRATION

PHR: PROJECT NARRATIVE The proposed phase 2 multicenter study will evaluate seliciclib in patients with Cushing disease caused by an adrenocorticotrophic hormone (ACTH)-secreting pituitary adenoma. Seliciclib is the only new agent currently in clinical trials in the US directly targeting pituitary corticotroph ACTH secretion and the consequent hypercortisolism that underlies excess morbidity and mortality associated with this rare disease. Results of the trial, conducted through a collaborative effort among all five major specialty pituitary centers in greater Los Angeles, will lay the foundation for additional trials of seliciclib in treating Cushing disease.

PI_NAMEs: MELMED, SHLOMO  (contact)

PROGRAM_OFFICER_NAME: MUELLER, CHRISTINE

PROJECT_TITLE: Ph 2 Multicenter study of seliciclib for Cushing Disease IND 120,848 (10/10/2017)


ORG_CITY: BUFFALO

ORG_NAME: ROSWELL PARK CANCER INSTITUTE CORP

PHR: The goal of this P01 Program is to develop novel strategies to selectively promote entry of antitumor killer cells (CTLs) into tumor microenvironments (TME) and reduce local accumulation of suppressive cells, in order to sensitize “cold” tumors to immune checkpoint inhibition (ICI) therapy. Our preclinical and early clinical data demonstrate that we can uniformly correct cancer TMEs using chemokine-modulating (CKM) regimen which concomitantly targets toll-like receptor-3 (TLR3), type-1 interferon (IFN) and prostaglandin systems, and specialized dendritic cell vaccines (αDC1). We will now test the immunologic and clinical efficacy of our novel therapies, identify the biomarkers of their antitumor effectiveness and potential undesirable effects, and will develop optimized and logistically feasible treatments for large groups of patients with immunotherapy- resistant tumors.

PI_NAMEs: KALINSKI, PAWEL  (contact)

PROGRAM_OFFICER_NAME: SONG, MIN-KYUNG H

PROJECT_TERMS: Adjuvant;Affect;anti-PD-1;Antigens;antitumor effect;Autologous;Biological Markers;Blood;Cancer Patient;cancer type;CD8-Positive T-Lymphocytes;CD8B1 gene;celecoxib;Cell Count;Cell Physiology;Cells;checkpoint inhibition;chemokine;chemokine receptor;Clinical;Clinical Data;Clinical effectiveness;clinical efficacy;Cohort Studies;colon cancer patients;Colorectal Cancer;combinatorial;Combined Modality Therapy;Complement;Correlative Study;Cross-Priming;Cytotoxic T-Lymphocytes;Data;Dendritic Cell Vaccine;design;Development;Dinoprostone;Disease;Effectiveness;Effector Cell;Future;Goals;Immune;immune checkpoint blockade;immune checkpoint blockers;immune clearance;Immune system;Immunologic Tests;Immunologics;Immunosuppression;Immunotherapy;improved;in situ vaccine;in vivo Model;Inpatients;Interferon alpha;Interferons;Killer Cells;Lesion;Ligands;Link;Liver;Malignant neoplasm of ovary;Malignant Neoplasms;Melanoma;Melanoma patient;metastatic colorectal;Microsatellite Repeats;Mus;Myeloid-derived suppressor cells;Natural Killer Cells;Neoplasms in Vascular Tissue;neoplastic cell;novel;novel strategies;novel therapeutics;objective response rate;Patients;Pattern;PD-1 blockade;PD-1/PD-L1;Peptide Vaccines;Peptides;Phase;phase I trial;phase II trial;pre-clinical;preclinical study;Prediction of Response to Therapy;Productivity;Program Research Project Grants;programmed cell death protein 1;programs;prospective;Prostaglandins;recruit;Refractory;refractory cancer;Regimen;Regulatory T-Lymphocyte;Resistance;response;Safety;Sequential Treatment;Solid Neoplasm;Specificity;Standardization;survival prediction;System;T cell infiltration;T cell therapy;tertiary lymphoid organ;Testing;Th1 Cells;Therapeutic;Therapeutic Effect;therapeutic effectiveness;therapeutic vaccine;therapy resistant;Tissues;TLR3 gene;TNF gene;tool;translational study;Treatment Efficacy;treatment optimization;tumor;tumor microenvironment;Vaccination;Vaccinee;Vaccines

PROJECT_TITLE: Targeting the Chemokine System to Sensitize Tumors to Immunotherapy


NIH_SPENDING_CATS: Cancer;Clinical Research;Colorectal Cancer;Digestive Diseases;Immunization;Immunotherapy;Vaccine Related

PHR: PROJECT 1 NARRATIVE We developed a novel combinatorial adjuvant (chemokine-modulatory regimen; CKM) to promote selective accumulation of anticancer immune cells (CTLs), uniformly throughout multiple colorectal cancer (CRC) lesions, but not healthy tissues, and suppress accumulation of tumor-promoting immune cells (Tregs). CKM showed immunologic and therapeutic efficacy in mice, showing strong synergy with checkpoint blockade in inducing cures in mice with established cancers and demonstrated safety end preliminary signs of local efficacy in patients with liver-metastatic CRC who received systemic (i.v) CKM (trial NCT01545141). Now, we propose to: 1) Perform phase IIa trial to demonstrate the immunologic activity of i.v.- administered CKM to promote in-patient increases in intratumoral CTL numbers; 2) Evaluate the impact of CKM on antitumor effectiveness of PD-1 blockade and vaccines in preclinical settings and identify the underlying mechanisms; and 3) Test the clinical activity of CKM combined with PD-1 blockade in CRC patients in inducing objective clinical responses (iRECIST).

PROJECT_TERMS: Adjuvant;Aftercare;anti-cancer;anti-PD-1;anticancer activity;Antigens;antitumor effect;Autologous;Biometry;Biopsy;celecoxib;Cells;chemokine;Clinical;clinical efficacy;Collaborations;colon cancer patients;Colorectal Cancer;combinatorial;conditioning;Data;Data Analyses;data dissemination;design;effective therapy;Effectiveness;effectiveness evaluation;Evaluation;Funding;Heterogeneity;human data;Image;Immune;immune checkpoint blockade;Immunity;Immunization;immunogenic;Immunologics;Immunotherapy;improved;In Vitro;in vivo;in vivo Model;individual patient;Infiltration;Inpatients;Interferon alpha;Interferon Type II;Lesion;Ligands;Liver;Malignant Neoplasms;MC38;metastatic colorectal;Microsatellite Instability;Microsatellite Repeats;Modeling;Multicenter Trials;Mus;Myeloid Cells;Natural Killer Cells;Neoplasms in Vascular Tissue;novel;patient response;patient subsets;Patients;Pattern;PD-1 blockade;PD-1/PD-L1;pembrolizumab;Peptides;Periodicity;Phase;phase 1 testing;phase I trial;Phase I/II Trial;phase II trial;Poly I-C;pre-clinical;preclinical study;predicting response;Production;programmed cell death ligand 1;programmed cell death protein 1;programs;prospective;PTGS2 gene;Regimen;Resistance;response;Rest;Role;Safety;Specificity;standard care;Stromal Cells;success;synergism;System;T-Lymphocyte;Testing;Therapeutic;Therapeutic Effect;tissue culture;Tissues;TLR3 gene;TNF gene;tool;Treatment Efficacy;tumor;Tumor Burden;tumor heterogeneity;tumor microenvironment;Tumor Promotion;Tumor Tissue;Tumor-infiltrating immune cells;Vaccination;Vaccines

PROJECT_TITLE: Project 1: Combinatorial adjuvants promote uniform and selective intratumoral CTL infiltration in colorectal cancer


NIH_SPENDING_CATS: Cancer;Cervical Cancer;Clinical Research;Clinical Trials and Supportive Activities;Dissemination and Implementation Research;HPV and/or Cervical Cancer Vaccines;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Immunization;Infectious Diseases;Pediatric;Prevention;Primary Health Care;Racial and Ethnic Minority Health Research;Rare Diseases;Sexually Transmitted Infections;Social Determinants of Health;Vaccine Related;Women's Health Research

ORG_CITY: DAVIS

ORG_NAME: UNIVERSITY OF CALIFORNIA AT DAVIS

PHR: The human papillomavirus (HPV) is a major public health threat that attributes to 34, 800 cancer cases annually in the United States, with the majority of these cases occurring in racial/ethnic minorities. Successful HPV vaccine coverage programs can reduce HPV-associated cancer disparities by ensuring that all populations are spared the morbidity and mortality due to HPV-related cancers. This proposal is relevant to the part of NCI's mission that pertains to leading the nation's research efforts to not only improve cancer prevention, but to also reduce disparities in cancer outcomes.

PI_NAMEs: DANG, JULIE  (contact)

PROGRAM_OFFICER_NAME: WALI, ANIL

PROJECT_TERMS: Address;Adolescent;adolescent patient;Adoption;Advocate;Affect;Age;aged;American;Area;arm;Behavior Therapy;Biostatistical Methods;boys;California;Cancer Burden;cancer health disparity;cancer prevention;career;career development;Cessation of life;Clinic;Clinical;Cluster randomized trial;Community Health;Community Physician;Computer software;Computerized Medical Record;Coupled;COVID-19 impact;COVID-19 pandemic effects;Data;Development;Development Plans;disparity reduction;Dissemination and Implementation;dissemination science;Dose;effectiveness evaluation;Ensure;ethnic disparity;ethnic minority;ethnic minority population;Ethnic Population;Evidence based intervention;experience;Feedback;Free Will;girls;Goals;health care service;Healthcare Systems;Herd Immunity;HPV vaccine acceptance;Human Papilloma Virus Vaccination;Human Papilloma Virus Vaccine;Human Papilloma Virus-Related Malignant Neoplasm;Human Papillomavirus;Immunization;implementation intervention;implementation research;implementation science;implementation strategy;improved;Influentials;Integrative Therapy;Intervention;Intervention Studies;Interview;Knowledge;Literature;Malignant neoplasm of cervix uteri;Malignant Neoplasms;Mentored Research Scientist Development Award;Mentors;Mentorship;Methods;Mission;Morbidity - disease rate;mortality;multidisciplinary;next generation;Outcome;Parents;Patients;people of color;Persons;Phase;Population;prevent;Prevention strategy;Preventive healthcare;Primary Care;primary care team;primary outcome;Primary Prevention;professor;Program Development;programs;Provider;Public Health;Race;racial disparity;racial minority;racial minority population;racial population;Randomized, Controlled Trials;Recommendation;recruit;Reporting;Research;Research Personnel;research study;Review Literature;Secure;Series;Site;skills;Structure;Surveys;systematic review;Techniques;Teenagers;Testing;Training;treatment as usual;trial design;United States;Universities;uptake;Vaccination;Vaccines;validation studies;Virus;Youth

PROJECT_TITLE: University of California, Davis: Human Papillomavirus Cancer Free (UCD: HPV Cancer Free)

STUDY_SECTION: NCI

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


NIH_SPENDING_CATS: Cancer;Clinical Research;Clinical Trials and Supportive Activities;Immunization;Immunotherapy;Orphan Drug;Ovarian Cancer;Rare Diseases;Vaccine Related;Women's Health Research

PHR: PROJECT NARRATIVE We propose to perform phase II component of the clinical trial (NCT02432378) to test if local chemokine modulating regimen (CKM) involving (i.p.) rintatolimod and IFNα is effective in guiding the αDC1 vaccine-induced CTLs to tumor tissues of patients with resectable ovarian cancer. We will evaluate COX2/PGE2 and PD-1/PD- L1/PD-L2 systems, as two complementary pathways of “secondary” suppression mobilized in OvCa TME in response to immune attack, and test and if the elimination of both these systems will result in therapeutic synergy in mice. Guided by the results of these studies, we will finalize the design and perform a trial to test if the combined treatment with αDC1 vaccines, CKM and PD-1 blockade, induces clinical responses in patients with unresectable OvCa.

PROJECT_TERMS: Adjuvant Chemotherapy;Animal Experiments;Animals;arginase;Blood;cancer immunotherapy;Cancer Model;Cancer Patient;CCL2 gene;CCL3 gene;CCR5 gene;CD8B1 gene;celecoxib;Cells;chemokine;chemotherapy;Clinical;Clinical Data;Clinical effectiveness;Clinical Research;Clinical Trials;cohort;Combined Modality Therapy;CXCL9 gene;CXCR3 gene;Data;Data Analyses;Dendritic Cells;design;Dinoprostone;Effectiveness;Effector Cell;efficacy clinical trial;Ensure;Evaluation;follow-up;Half-Life;Human;Immune;Immunosuppression;Immunotherapy;improved;Infiltration;insight;Interferon alpha;Interferon Type II;Interleukin-10;Ligands;Malignant neoplasm of ovary;Malignant Neoplasms;Mediating;Mediator;Mus;Natural Killer Cells;Neoadjuvant Therapy;NOS2A gene;Operative Surgical Procedures;Outcome;Pathway interactions;Patient-Focused Outcomes;Patients;Pattern;PD-1 blockade;PD-1/PD-L1;Peritoneal Fluid;Phase;Phase I/II Trial;pre-clinical;preclinical study;primary endpoint;Production;programmed cell death ligand 1;programmed cell death protein 1;programs;PTGS2 gene;Quality of life;Randomized;RANTES;Recurrence;Regimen;Regulatory T-Lymphocyte;Resectable;Resected;Resistance;response;Role;Safety;Signal Transduction;Site;synergism;System;Testing;Th1 Cells;Therapeutic;Therapeutic Effect;therapeutic effectiveness;TLR3 gene;TNF gene;Transplantation;Treatment Protocols;tumor;tumor microenvironment;Tumor Tissue;University of Pittsburgh Cancer Institute;Unresectable;Vaccinated;Vaccination;Vaccines;WFDC2 gene

PROJECT_TITLE: Project 2: Local immunotherapy corrects chemokine patterns in ovarian cancer